Clamping arm forceps to minimize tissue adhesion and improve tissue control

Abstract

An end effector and a surgical instrument including the end effector are disclosed. The end effector includes a clamp arm and an ultrasonic blade configured to acoustically couple to an ultrasonic transducer and electrically couple to one pole of a generator. The clamp arm includes a clamp jaw and a cantilever electrode configured to electrically couple to an opposite pole of the generator. The cantilever electrode is fixed to the clamp jaw at a proximal end and is free to deflect at a distal end. The clamp arm includes a control feature to adjust a tissue path relative to the clamp arm to form a predetermined contact location.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application Serial No. 62 / 955,292, entitled “COMBINATION ENERGY MODALITY END-EFFECTOR” and filed December 30, 2019, the disclosure of which is incorporated by reference herein in its entirety. TECHNICAL FIELD

[0003] The present disclosure relates generally to end effectors that are adapted and configured to operate with multiple energy modalities such that tissue sealing and cutting can be performed with energy modalities applied simultaneously, independently, or sequentially. More particularly, the present disclosure relates to end effectors that are adapted and configured to operate with surgical instruments that employ a combination of ultrasonic and electrosurgical systems, such as monopolar or bipolar radiofrequency (RF), such that tissue sealing and cutting can be performed with ultrasonic and electrosurgical energy modalities applied simultaneously, independently, or sequentially. The energy modalities can be applied based on tissue parameters or other algorithms. The end effectors can be adapted and configured to be coupled to a hand-held or robotic surgical system. BACKGROUND

[0004] Ultrasonic surgical instruments employing an ultrasonic energy modality are finding increasing use in surgical procedures by virtue of the unique performance characteristics of such instruments. Depending on the particular instrument configuration and operating parameters, an ultrasonic surgical instrument can substantially simultaneously effect cutting of tissue and hemostasis by coagulation, advantageously minimizing patient trauma. The cutting action is typically effected by an end effector, ultrasonic blade, or ultrasonic blade head at the distal end of the instrument, which transmits ultrasonic energy to tissue in contact with the end effector. The ultrasonic end effector can include an ultrasonic blade, clamp arm and pad, and other components.

[0005] Some surgical instruments use ultrasonic energy for both precise cutting and controlled coagulation. Ultrasonic energy cuts and coagulates by a blade in contact with tissue vibrating at high frequency (e.g., 55,500 times per second). The ultrasonic blade denatures proteins in the tissue to form a sticky coagulum with the high frequency vibrations. Pressure from the blade surface applied to the tissue collapses blood vessels and allows the coagulum to form a hemostatic seal. The precision of the cutting and coagulation is controlled by the surgeon’s technique and adjustment of power level, blade edge, tissue traction, and blade pressure.

[0006] Electrosurgical instruments for applying modalities of electrical energy to tissue to treat, seal, cut, and / or destroy tissue are also increasingly used in surgical procedures. Electrosurgical instruments generally include an instrument having a distally mounted end effector that includes one or more electrodes. The end effector can be positioned against 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., active electrode) and returned from the tissue through a second electrode (e.g., return electrode). During monopolar operation, electrical current is introduced into the tissue through an active electrode of the end effector and returned, e.g., through a return electrode such as a grounding pad that is separately coupled to the patient's body. The heat generated by the current flowing through the tissue can create a hemostatic seal within and / or between tissue and can thus be particularly useful, for example, to seal blood vessels. The end effector of an electrosurgical instrument can also include a cutting member that can be moved relative to the tissue and electrodes to transect the tissue. Electrosurgical end effectors can be adapted and configured to be coupled to hand-held instruments as well as robotic instruments.

[0007] Electrical energy applied by an electrosurgical instrument can be delivered to the instrument by a generator in communication with a handpiece. The electrical energy can be in the form of radiofrequency ("RF") energy. RF energy is a form of electrical energy that can be in the frequency range of 200 kilohertz (kHz) to 1 megahertz (MHz). In application, an electrosurgical instrument can deliver low frequency RF energy through tissue, which causes ionic agitation or friction, which in effect creates resistive heat, raising the temperature of the tissue. Because there is a distinct boundary between the affected tissue and the surrounding tissue, the surgeon is able to operate with high precision and control without damaging adjacent non-targeted tissue. The low operating temperatures of RF energy are suitable for removing, shrinking, or molding soft tissue while sealing blood vessels. RF energy is particularly effective for use with connective tissue, which is primarily composed of collagen and shrinks upon contact with heat.

[0008] RF energy can be in the frequency range described in EN 60601-2-2:2009+A11:2011, Definition 201.3.218 - High Frequency. For example, the frequency in monopolar RF applications can generally be limited to less than 5 MHz. However, in bipolar RF energy applications, the frequency can be almost any value. Monopolar applications can generally use frequencies higher than 200 kHz in order to avoid unwanted stimulation of nerves and muscles due to the use of low frequency currents. Bipolar applications can use lower frequencies if the risk analysis shows that the likelihood of neuromuscular stimulation has been mitigated to an acceptable level. Generally, frequencies higher than 5 MHz are not used in order to minimize problems associated with high frequency leakage currents. However, higher frequencies can be used in the case of bipolar applications. It is generally accepted that 10 mA is the lower threshold for tissue heating effects.

[0009] The ultrasonic and electrosurgical instruments described herein can be configured for open surgical procedures, minimally invasive surgical procedures, or non-invasive surgical procedures. Minimally invasive surgical procedures involve the use of cameras and instruments inserted through small incisions in order to visualize and treat conditions within a joint or body cavity. Minimally invasive procedures can be performed entirely within the body, or in some cases, can be used with smaller open procedures. These combined approaches are referred to, for example, as “arthroscopic, laparoscopic, or thoracoscopic-assisted surgical procedures.” The surgical instruments described herein can also be used for non-invasive procedures, such as, for example, endoscopic surgical procedures. These instruments can be controlled by a surgeon using handheld instruments or a robot.

[0010] A challenge with these surgical instruments is the inability to control and customize the individual or multiple energy modalities according to 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 of these operations. The combined energy modality end effectors described herein overcome these deficiencies and improve the quality of tissue treatment, sealing, or cutting, or a combination of these operations. SUMMARY

[0011] In one aspect, a device for dissecting and coagulating tissue is provided. The device includes a surgical instrument having an end effector adapted and configured to deliver multiple energy modalities to tissue located at a distal end thereof. The energy modalities can be applied simultaneously, independently, or sequentially. A generator is electrically coupled to the surgical instrument and configured to provide multiple energy modalities to the end effector. In one aspect, the generator is configured to provide electrosurgical energy (e.g., monopolar or bipolar radiofrequency (RF) energy) and ultrasonic energy to the end effector to allow the end effector to interact with tissue. The energy modalities can be provided to the end effector by a single generator or multiple generators.

[0012] In various aspects, the present disclosure provides a surgical instrument configured to deliver at least two energy types (e.g., ultrasonic, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue. The surgical instrument includes a first activation button for activating energy, a second button for selecting an energy mode for 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 through a connection to a generator or through a software update.

[0013] 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 jaw, a flexible 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 an ultrasonic generator. In one aspect, the at least one electrode acts as a deflectable support relative to the opposing ultrasonic blade. The at least one electrode passes through the ultrasonic blade and is configured to be deflectable relative to the clamp arm having a feature that changes the mechanical properties of tissue compression beneath the at least one electrode. The at least one electrode includes a feature that prevents accidental contact between the electrode and the ultrasonic blade.

[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 movable jaw, a flexible 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 an ultrasonic generator. In one aspect, the movable jaw includes at least one non-biased deflectable electrode to minimize contact between the ultrasonic blade and the RF electrode. The ultrasonic blade pad includes a feature for securing the electrode to the pad. As the pad wears down or is cut through, the height of the electrode relative to the jaw is adjusted in a gradual manner. Once the jaw is moved away from the ultrasonic blade, the electrode remains in its new position.

[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 movable jaw, a flexible 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 an ultrasonic generator. In one aspect, the at least one bipolar RF electrode is deflectable and has more distal bias than proximal bias. The bipolar RF electrode is deflectable relative to the jaw. The end effector is configured to change the mechanical properties of tissue compression from the proximal end to the distal end to create a more uniform or different pressure pattern than that created by clamping alone.

[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 flexible 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 an ultrasonic generator. In one aspect, the bipolar RF electrode is deflectable and the end effector provides variable compression / biasing along the length of the deflectable electrode. The end effector is configured to vary the mechanical properties of tissue compression under the electrode based on the amount of jaw closure or clamping.

[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 flexible 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 an ultrasonic generator. In one aspect, the pad includes asymmetric segments to provide support to the ultrasonic blade support and the electrode is movable. The asymmetric segmented pad is configured for cooperative engagement with 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 substantially higher than a second pad element. The first pad element extends entirely 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 are made of different materials.

[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 flexible 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 an ultrasonic generator. In one aspect, the physical parameters of the electrode are varied in conjunction with a deflectable electrode to vary the energy density and tissue interaction delivered to the tissue. The physical aspects of the electrode vary along its length so as to vary the contact area and / or energy density of the electrode to the tissue as the electrode is also deflected.

[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 movable clamp jaw, a flexible polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to the positive pole of an RF generator and the ultrasonic blade is coupled to the negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, an ultrasonic transducer control algorithm is provided to reduce the power delivered by the ultrasonic or RF generator upon detection of a contact short between the ultrasonic blade and the electrode, thereby preventing damage to the ultrasonic blade. The ultrasonic blade control algorithm monitors for an electrical short or contact of the ultrasonic blade with the electrode. This detection is used to adjust the power / amplitude level of the ultrasonic transducer when an electrical threshold minimum is exceeded, and the transducer power / amplitude threshold is adjusted to a level below the minimum threshold that can cause damage to the ultrasonic blade, the ultrasonic generator, the bipolar RF electrode, or the 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, the bipolar RF generator of the surgical device, or it can be a proportional response to the electrical parameter, pressure, or time, or any combination of these parameters.

[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 flexible polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to the positive pole of an RF generator and the ultrasonic blade is coupled to the negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, features or aspects of the clamp jaw are provided in the clamp arm to minimize tissue sticking and improve tissue control. The clamp arm tissue path or clamp area includes features configured to enable adjustment of the tissue path relative to the clamp arm / ultrasonic blade to create predetermined contact locations to reduce tissue sticking and charring.

[0021] 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 jaw, a flexible 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 an ultrasonic generator. In one aspect, a partially conductive clamp arm pad is provided to enable the electrode to wear through and minimize electrical shorting between the ultrasonic blade and the bipolar RF electrode. The clamp arm pad includes a conductive portion and a non-conductive portion, such that it acts as one of the bipolar RF electrodes while also acting as a wear-resistant support structure for the ultrasonic blade. The conductive portion of the clamp arm pad is positioned around the perimeter of the pad and not directly under the ultrasonic blade contact area. The conductive portion is configured to be able to deteriorate or wear away to prevent any contact with the ultrasonic blade from interrupting the conductivity of the remaining conductive pad.

[0022] In addition to the foregoing, various other method and / or system and / or program product aspects are set forth and described in the teachings of the present disclosure, such as in the text (e.g., claims and / or detailed description) and / or drawings of the present disclosure.

[0023] The foregoing is a summary and thus can include simplification, generalization, omissions, and / or the like. Consequently, it is to be understood that the summary is illustrative only and does not necessarily describe essential

[0024] In one or more aspects of the various aspects, the relevant system includes, but is not limited to, circuitry and / or programming for carrying out the method aspects cited herein; the circuitry and / or programming can be virtually any combination of hardware, software, and / or firmware configured to affect the method aspects cited herein according to the design choices of the system designer. In addition to the foregoing, various other method and / or system aspects are set forth and described in the teachings of the present disclosure, such as in the text (e.g., claims and / or detailed description) and / or drawings of the present disclosure.

[0025] Further, it should be appreciated that any one or more of the following forms, form expressions, examples can be combined with any one or more of the other forms, form expressions, and examples below.

[0026] The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments and features described above, those skilled in the art will readily appreciate some other aspects, embodiments and features based on the teachings of the figures and claims included herewith, including design of systems, mechanisms, instrumentalities and / or methods to perform the operations, operations, functions, and / or behaviors described in this summary and / or the accompanying detailed description, as follows. BRIEF DESCRIPTION OF DRAWINGS

[0027] The novel features of the form described in this summary are set forth with particularity in the claims that follow. The form, however, together with its best mode of practicing the form, can be better understood by reference to the following description, taken in conjunction with the accompanying drawings, in which:

[0028] Figure 1 is a perspective view of a clamp arm portion of an end effector for use with a combination ultrasonic / RF device in accordance with at least one aspect of the present disclosure.

[0029] Figure 2 is a perspective view of a frame in accordance with at least one aspect of the present disclosure. Figure 1 is an exploded view of a clamp arm shown.

[0030] Figure 3 and Figure 4 is a perspective view of a frame in accordance with at least one aspect of the present disclosure.

[0031] Figure 5 is a perspective view of an electrode in accordance with at least one aspect of the present disclosure.

[0032] Figure 6 is a perspective view of a clamp arm pad in accordance with at least one aspect of the present disclosure.

[0033] Figure 7 is a perspective top view of a large gap pad in accordance with at least one aspect of the present disclosure.

[0034] Figure 8 is a perspective top view of a small gap pad in accordance with at least one aspect of the present disclosure.

[0035] Figure 9 is a perspective bottom view of a small gap pad shown. Figure 8

[0036] Figure 10 to Figure 12 shows an effector including a shortened clamp arm suitable for a deflectable / jibbed electrode application in accordance with various aspects of the present disclosure, wherein:

[0037] Figure 10 is a side view of an end effector including a shortened clamp arm, an ultrasonic blade, an electrode, and a clamp arm pad in accordance with at least one aspect of the present disclosure;

[0038] Figure 11 is a top view of an end effector in accordance with at least one aspect of the present disclosure; and

[0039] Figure 12 shows a clamp arm including a clamp, an electrode, and a clamp arm pad in accordance with at least one aspect of the present disclosure.

[0040] Figure 13 ​An end effector clamp arm including a clamp, an electrode, and a clamp arm pad is shown in accordance with at least one aspect of the present disclosure.

[0041] Figure 14 An end effector clamp arm including a clamp, an electrode, and a clamp arm pad is shown in accordance with at least one aspect of the present disclosure.

[0042] Figure 15 An end effector clamp arm including a clamp, an electrode, and a clamp arm pad is shown in accordance with at least one aspect of the present disclosure.

[0043] Figure 16 Worn bottom retainer teeth are shown in accordance with at least one aspect of the present disclosure such that the electrode can move toward the clamp due to a preformed curve.

[0044] Figure 17 An end effector clamp arm including a clamp, an electrode, and a clamp arm pad is shown in accordance with at least one aspect of the present disclosure.

[0045] Figure 18 Retainer walls with a worn tapered profile are shown in accordance with at least one aspect of the present disclosure such that there is enough melt / flow off the retainer wall with the tapered profile area to allow the electrode to move toward the clamp due to a preformed curve.

[0046] Figure 19 to Figure 21 An end effector including a clamp arm, an ultrasonic blade, a mesh pad, a flexible electrode disposed above the mesh pad, and a plurality of hard spacers to set a gap between the flexible electrode and the ultrasonic blade is shown in accordance with at least one aspect of the present disclosure, wherein:

[0047] Figure 19 A clamp arm is shown open and a tissue (T 1a , T 2a , T 3a ) is disposed above the flexible electrode;

[0048] Figure 20 The clamp arm is shown closed to compress the tissue; and

[0049] Figure 21 An exploded view of the end effector shown in Figure 19 to Figure 20

[0050] Figure 22 A cross-sectional view of a conductive polymer clamp arm pad in accordance with at least one aspect of the present disclosure.

[0051] Figure 23 A perspective view of a clamp arm pad configured to be able to replace a conventional electrode in accordance with at least one aspect of the present disclosure. ​

[0052] Figure 24 A clamp arm is shown including a clamp jaw and a clamp arm pad configured as described in Figure 23 the clamp arm.

[0053] Figure 25 A clamp arm is shown including a clamp jaw and a clamp arm pad configured as described in Figure 23 to Figure 24 the clamp arm.

[0054] Figure 26 is a cross-sectional view of a clamp arm including a composite clamp arm pad in contact with tissue according to at least one aspect of the present disclosure.

[0055] Figure 27 A clamp arm is shown including a clamp jaw and a clamp arm pad configured as described in the clamp arm.

[0056] Figure 28 is a cross-sectional view taken along section 28-28 in Figure 27 .

[0057] Figure 29 is a cross-sectional view taken along section 29-29 in Figure 27 .

[0058] Figure 30 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 according to at least one aspect of the present disclosure.

[0059] Figure 31 is a cross-sectional view of an alternative implementation of a clamp arm including a clamp jaw, a bracket or stamp welded to the clamp jaw, a conductive pad, and a non-conductive pad according to at least one aspect of the present disclosure.

[0060] Figure 32 An insert molded electrode is shown according to at least one aspect of the present disclosure.

[0061] Figure 33 An end effector is shown including an ultrasonic blade, a clamp arm, and a clamp arm pad including a conductive film according to at least one aspect of the present disclosure.

[0062] Figure 34 A clamp arm is shown including a clamp jaw and a clamp arm pad configured as described in Figure 33 the clamp arm.

[0063] Figure 35 is a cross-sectional view of a clamp arm taken along section 35-35 in Figure 34 .

[0064] Figure 36 A clamp arm is shown including a clamp jaw and a clamp arm pad configured as described in the clamp arm.

[0065] Figure 37 A clamp arm is shown that includes a clamp jaw, a clamp arm pad having exposed teeth, according to at least one aspect of the present disclosure.

[0066] Figure 38 A clamp arm is shown that includes a clamp jaw having raised sidewalls and a raised lip, and a clamp arm pad having a plurality of teeth, according to at least one aspect of the present disclosure.

[0067] Figure 39 to Figure 42 An electrode having a peripheral wall is shown, according to at least one aspect of the present disclosure, wherein:

[0068] Figure 39 A clamp arm is shown that includes an electrode having a peripheral wall supported by a clamp jaw and a clamp arm pad, according to at least one aspect of the present disclosure;

[0069] Figure 40 is a cross-sectional view of a clamp jaw taken along section 40-40 in Figure 39 ; and

[0070] Figure 41 is an alternative or additional feature according to at least one aspect of the present disclosure, wherein a sealant such as silicone or other fluid polymer can be provided in the space below the electrode and above the clamp jaw to prevent tissue from traveling and accumulating below the electrode.

[0071] Figure 42 A clamp arm is shown that includes a clamp jaw, an electrode, a clamp arm pad having a plurality of teeth ( Figure 43 ), and a deflectable flange along the lateral sides of the electrode, according to at least one aspect of the present disclosure.

[0072] Figure 43 and Figure 44 is a cross-sectional view of the clamp arm shown in Figure 42 , wherein:

[0073] Figure 43 An electrode and a skirt are shown in an undeflected state; and

[0074] Figure 44 An electrode and a skirt are shown in a deflected state, wherein the skirt is laterally displaced in the direction shown by the arrow.

[0075] Figure 45 A clamp arm is shown that includes a clamp jaw, an electrode, and a sidewall extending downward from the electrode past a sidewall of the clamp jaw, and a clamp arm pad having a plurality of teeth ( Figure 46 ), according to at least one aspect of the present disclosure.

[0076] Figure 46is a cross-sectional view taken along section 46-46 Figure 45 is a cross-sectional view of the clamp arm shown.

[0077] Figure 47 is shown. Figure 45 to Figure 46 is an alternative clamp arm of the clamp arm shown.

[0078] Figure 48 is a top perspective view of an electrode according to at least one aspect of the present disclosure, the electrode including a lip extending downward from a top surface of the electrode.

[0079] Figure 49 is a top perspective view of an electrode according to at least one aspect of the present disclosure. Figure 48 is a bottom perspective view of the electrode shown, showing the lip extending downward.

[0080] Figure 50 is a bottom perspective view of an electrode according to at least one aspect of the present disclosure. Figure 48 to Figure 49 is a top perspective view of the electrode shown, wherein the clamp arm pad has a tooth extending through the aperture.

[0081] Figure 51 is a top perspective view of an electrode according to at least one aspect of the present disclosure, wherein the clamp arm pad has a tooth extending through the aperture. Figure 48 to Figure 49

[0082] Figure 52 is shown.

[0083] Figure 53 is shown.

[0084] Figure 54 is shown. Figure 53 is an assembled version of the end effector of the components shown.

[0085] Figure 55 is shown.

[0086] Figure 56 is shown.

[0087] Figure 57 is shown.

[0088] Figure 58 is a perspective view of the elastic / super-elastic block. ​

[0089] Figure 59 is a perspective view of a sub-assembly including a clamp, an electrode, and a single tissue pad unit according to at least one aspect of the present disclosure.

[0090] Figure 60 is a perspective view of a sub-assembly including a clamp, an electrode, and a single tissue pad unit according to at least one aspect of the present disclosure. Figure 58 is a perspective view of a clamp arm assembly including a resilient / super-elastic block of

[0091] Figure 61 is a perspective view of a sub-assembly including a clamp, an electrode, and a single tissue pad unit according to at least one aspect of the present disclosure.

[0092] Figure 62 shows a first assembly step according to at least one aspect of the present disclosure in which a single tissue pad unit is inserted into an electrode.

[0093] Figure 63 to Figure 65 shows a second assembly step according to at least one aspect of the present disclosure in which:

[0094] Figure 63 shows a single tissue pad unit locked into an electrode;

[0095] Figure 64 shows a tissue pad unit in an unlocked position; and

[0096] Figure 65 shows a tissue pad unit in a locked position.

[0097] Figure 66 shows a third assembly step according to at least one aspect of the present disclosure in which a single piece resilient / super-elastic block is incorporated into a clamp.

[0098] Figure 67 to Figure 72 shows a fourth assembly step according to at least one aspect of the present disclosure in which:

[0099] Figure 67 shows a first sub-assembly resulting from Figure 63 to Figure 65 the second assembly step described above being assembled with a second sub-assembly resulting from Figure 66 the third assembly described above in the step described above to result in a clamp arm;

[0100] Figure 68 shows a pad end in general alignment with a clamp arm slot;

[0101] Figure 69 shows an electrode incorporated into a clamp arm at a junction point;

[0102] Figure 70 shows a clamp arm feature preventing a tissue pad unit from appearing in the direction indicated by the arrow;

[0103] Figure 71 is a detail view of the electrode being bonded to the clamp arm at the bond point;

[0104] Figure 72 is a detail view of the electrode being bonded to the clamp arm at the bond point.

[0105] Figure 73 to Figure 74 shows a fifth assembly step in accordance with at least one aspect of the present disclosure, wherein:

[0106] Figure 73 shows the assembly of two small wear gap pads being press fit into the slots defined by the electrode and the large wear gap pad sliding into the slot defined by the electrode; and

[0107] Figure 74 is an end view of the clamp arm.

[0108] Figure 75 shows a clamp arm including a fill material between the electrode and the clamp jaw in accordance with at least one aspect of the present disclosure.

[0109] Figure 76 to Figure 78 shows various devices addressing these desired improvements in accordance with at least one aspect of the present disclosure, wherein:

[0110] Figure 76 shows a clamp arm that is easier to manufacture by eliminating a separate clamp arm electrode and establishing the clamp arm surface and eliminating a separate electrode knife;

[0111] Figure 77 shows a clamp arm that prevents tissue accumulation between the electrode and the clamp jaw by adding a skirt to the periphery of the electrode or alternatively to the periphery of the clamp jaw; and

[0112] Figure 78 shows a cross-sectional view of an end effector including an ultrasonic blade and a clamp arm configured to improve distal tissue grasp.

[0113] Figure 79 shows a clamp arm in accordance with at least one aspect of the present disclosure including a clamp jaw, an electrode, a clamp arm pad having a plurality of teeth, a drape on either side of the electrode to minimize a point of tissue extrusion, and a bullnose / clamp arm bumper that minimizes electrode delamination by contacting tissue first during blunt dissection.

[0114] Figure 80 to Figure 81 shows an alternative clamp arm in accordance with at least one aspect of the present disclosure including a clamp jaw, an electrode, a clamp arm pad having a plurality of teeth, and a drape on either side of the clamp arm pad, wherein:

[0115] Figure 80 is an exploded view of the clamp arm; and

[0116] Figure 81 is a cross-sectional view of a clamp arm.

[0117] Figure 82 is a side view of a clamp arm according to at least one aspect of the present disclosure.

[0118] Figure 83 is a side view of a clamp arm according to at least one aspect of the present disclosure, with a cantilever electrode in a deflected state to pull tissue out of the teeth of the clamp arm pad.

[0119] Figure 84 is a bottom perspective view of a clamp arm according to at least one aspect of the present disclosure.

[0120] Figure 85 is a bottom perspective view of a clamp arm according to at least one aspect of the present disclosure, with a cantilever electrode in a deflected state to pull tissue out of the teeth of the clamp arm pad.

[0121] Figure 86 shows a surgical device including a mode selection button switch on the device according to at least one aspect of the present disclosure.

[0122] Figure 87A to Figure 87C shows three options for selecting various modes of operation of a surgical device according to at least one aspect of the present disclosure, wherein:

[0123] Figure 87A shows a first mode selection option, wherein the button switch can be pressed forward or backward to cycle the surgical instrument between various modes;

[0124] Figure 87B shows a second mode selection option, wherein the button switch is pressed up or down to cycle the surgical instrument between various modes; and

[0125] Figure 87C shows a third mode selection option, wherein the button switch is pressed forward, backward, up, or down to cycle the surgical instrument between various modes.

[0126] Figure 88 shows a surgical device including a mode selection button switch on the back of the device according to at least one aspect of the present disclosure.

[0127] Figure 89A shows a first mode selection option, wherein as the mode button switch is pressed to switch between various modes, a colored light indicates the selected mode on the user interface.

[0128] Figure 89BA second mode selection option is shown, where the screen indicates the selected mode (e.g., LCD, e-ink) as the mode button switch is pressed to switch between various modes.

[0129] Figure 89C The third mode selection option is shown, where a marked light indicates the selected mode as the mode button switch is pressed to switch between various modes.

[0130] Figure 89D The fourth mode selection option is shown, where the marked button switch is lit up to indicate the selected mode when it is pressed to select a mode.

[0131] Figure 90 A surgical device including a trigger activation mechanism is shown according to at least one aspect of the present disclosure.

[0132] Figure 91 An alternative clamping arm, comprising a metal clamp, an electrode, a plurality of clamping arm pads, and a gap pad, is shown according to at least one aspect of the present disclosure.

[0133] Figure 92 A surgical system according to at least one aspect of this disclosure includes a surgical hub paired with a visualization system, a robotic system, and a smart device.

[0134] Figure 93 An example of a generator according to at least one aspect of this disclosure is shown.

[0135] Figure 94 It is a diagram of various modules and other components that can be combined to customize a modular energy system according to at least one aspect of this disclosure.

[0136] Figure 95A The first exemplary modular energy system configuration according to at least one aspect of this disclosure includes a head module and a display screen that presents a graphical user interface (GUI) for relaying information about modules connected to the head module.

[0137] Figure 95B It is installed on the cart according to at least one aspect of this disclosure. Figure 95A The modular energy system shown.

[0138] Figure 96 A perspective view of an exemplary surgical system according to at least one aspect of this disclosure is shown, the system having a generator and surgical instruments operable to process tissue using ultrasonic energy and bipolar RF energy.

[0139] Figure 97 At least one aspect of this disclosure is shown. Figure 96a top perspective view of an end effector of a surgical instrument having a clamp arm providing a first electrode and an ultrasonic blade providing a second electrode.

[0140] Figure 98 a top perspective view of an end effector of a surgical instrument is shown in accordance with at least one aspect of the present disclosure Figure 97 a bottom perspective view of an end effector of a surgical instrument.

[0141] Figure 99 a top perspective view of an end effector of a surgical instrument is shown in accordance with at least one aspect of the present disclosure Figure 96 a partial exploded perspective view of a surgical instrument.

[0142] Figure 100 a top perspective view of an end effector of a surgical instrument is shown in accordance with at least one aspect of the present disclosure Figure 96 an enlarged exploded perspective view of a distal portion of a shaft assembly of a surgical instrument and an end effector. DETAILED DESCRIPTION

[0143] Applicant of the present application owns the following U.S. Provisional Patent Applications that were filed on December 30, 2019 and the disclosure of each of which is herein incorporated by reference in its entirety:

[0144] • U.S. Provisional Patent Application Serial No. 62 / 955,294, entitled USER INTERFACE FOR SURGICAL INSTRUMENT WITH COMBINATION ENERGY MODALITY END-EFFECTOR;

[0145] • U.S. Provisional Patent Application Serial No. 62 / 955,299, entitled ELECTROSURGICAL INSTRUMENTS FOR COMBINATION ENERGY DELIVERY; and

[0146] • U.S. Provisional Patent Application Serial No. 62 / 955,306, entitled SURGICAL INSTRUMENTS.

[0147] Applicant of the present application owns the following U.S. Patent Applications that were filed on the same date as the present application and which are each herein incorporated by reference in their entirety:

[0148] • Attorney Docket No. END9232USNP1 / 190715-1, entitled USER INTERFACE FOR SURGICAL INSTRUMENT WITH COMBINATION ENERGY MODALITY END-EFFECTOR;

[0149] • Attorney Docket No. END9233USNP1 / 190716-1M, entitled METHOD OF OPERATING A COMBINATION ULTRASONIC / BIPOLAR RF SURGICAL DEVICE WITH A COMBINATION ENERGY MODALITY END-EFFECTOR;

[0150] • Attorney Docket No. END9233USNP2 / 190716-2, entitled DEFLECTABLE SUPPORT OF RF ENERGY ELECTRODE WITH RESPECT TO OPPOSING ULTRASONIC BLADE;

[0151] • Attorney Docket No. END9233USNP3 / 190716-3, entitled NON-BIASED DEFLECTABLE ELECTRODE TO MINIMIZE CONTACT BETWEEN ULTRASONIC BLADE AND ELECTRODE;

[0152] • Attorney Docket No. END9233USNP4 / 190716-4, entitled DEFLECTABLE ELECTRODE WITH HIGHER DISTAL BIAS RELATIVE TO PROXIMAL BIAS;

[0153] • Attorney Docket No. END9233USNP5 / 190716-5, entitled DEFLECTABLE ELECTRODE WITH VARIABLE COMPRESSION BIAS ALONG THE LENGTH OF THE DEFLECTABLE ELECTRODE;

[0154] • Attorney Docket No. END9233USNP6 / 190716-6, entitled ASYMMETRIC SEGMENTED ULTRASONIC SUPPORT PAD FOR COOPERATIVE ENGAGEMENT WITH A MOVABLE RF ELECTRODE;

[0155] • Attorney Docket No. END9233USNP7 / 190716-7, entitled VARIATION IN ELECTRODE PARAMETERS AND DEFLECTABLE ELECTRODE TO MODIFY ENERGY DENSITY AND TISSUE INTERACTION;

[0156] • Attorney Docket No. END9233USNP8 / 190716-8, entitled TECHNIQUES FOR DETECTING ULTRASONIC BLADE TO ELECTRODE CONTACT AND REDUCING POWER TO ULTRASONIC BLADE; and

[0157] • Attorney Docket No. END9233USNP10 / 190716-10, entitled PARTIALLY CONDUCTIVE CLAMP ARM PAD TO ENABLE ELECTRODE WEAR THROUGH AND MINIMIZE SHORT CIRCUITING.

[0158] Applicant of the present application owns the following U.S. Patent Applications that were filed on May 28, 2020 and which are each herein incorporated by reference in their entirety:

[0159] • U.S. Patent Application Serial No. 16 / 885,813, entitled METHOD FOR AN ELECTROSURGICAL PROCEDURE;

[0160] • U.S. Patent Application Serial No. 16 / 885,820, entitled ARTICULATABLE SURGICAL INSTRUMENT;

[0161] • U.S. Patent Application Serial No. 16 / 885,823, entitled SURGICAL INSTRUMENT WITH JAW ALIGNMENT FEATURES;

[0162] • U.S. Patent Application Serial No. 16 / 885,826, entitled SURGICAL INSTRUMENT WITH ROTATABLE AND ARTICULATABLE SURGICAL END EFFECTOR;

[0163] • U.S. Patent Application Serial No. 16 / 885,838, entitled ELECTROSURGICAL INSTRUMENT WITH ASYNCHRONOUS ENERGIZING ELECTRODES;

[0164] • U.S. Patent Application Serial No. 16 / 885,851, entitled ELECTROSURGICAL INSTRUMENT WITH ELECTRODES BIASING SUPPORT;

[0165] • U.S. Patent Application Serial No. 16 / 885,860, entitled ELECTROSURGICAL INSTRUMENT WITH FLEXIBLE WIRING ASSEMBLIES;

[0166] • U.S. Patent Application Serial No. 16 / 885,866, entitled ELECTROSURGICAL INSTRUMENT WITH VARIABLE CONTROL MECHANISMS;

[0167] • U.S. Patent Application Serial No. 16 / 885,870, entitled ELECTROSURGICAL SYSTEMS WITH INTEGRATED AND EXTERNAL POWER SOURCES;

[0168] • U.S. Patent Application Serial No. 16 / 885,873, entitled ELECTROSURGICAL INSTRUMENTS WITH ELECTRODES HAVING ENERGY FOCUSING FEATURES;

[0169] • U.S. Patent Application Serial No. 16 / 885,879, entitled ELECTROSURGICAL INSTRUMENTS WITH ELECTRODES HAVING VARIABLE ENERGY DENSITIES;

[0170] • U.S. Patent Application Serial No. 16 / 885,881, entitled ELECTROSURGICAL INSTRUMENT WITH MONOPOLAR AND BIPOLAR ENERGY CAPABILITIES;

[0171] • U.S. Patent Application Serial No. 16 / 885,888, entitled ELECTROSURGICAL END EFFECTORS WITH THERMALLY INSULATIVE AND THERMALLY CONDUCTIVE PORTIONS;

[0172] • U.S. Patent Application Serial No. 16 / 885,893, entitled ELECTROSURGICAL INSTRUMENT WITH ELECTRODES OPERABLE IN BIPOLAR AND MONOPOLAR MODES;

[0173] • U.S. Patent Application Serial No. 16 / 885,900, entitled ELECTROSURGICAL INSTRUMENT FOR DELIVERING BLENDED ENERGY MODALITIES TO TISSUE;

[0174] • U.S. Patent Application Serial No. 16 / 885,917, entitled CONTROL PROGRAM ADAPTATION BASED ON DEVICE STATUS AND USER INPUT;

[0175] • U.S. Patent Application Serial No. 16 / 885,923, entitled CONTROL PROGRAM FOR MODULAR COMBINATION ENERGY DEVICE; and

[0176] • U.S. Patent Application Serial No. 16 / 885,931, entitled SURGICAL SYSTEM COMMUNICATION PATHWAYS.

[0177] Before the various forms of the surgical instrument are described in detail, it is to be understood that the application of the exemplary forms is not limited in scope to the details of construction and the arrangement of the components shown in the figures and described in the specific embodiments. The exemplary forms can be implemented individually or in combination with other forms, variations, and modifications, and can be practiced or carried out in various ways. Further, the terms and expressions used herein are selected for the purpose of describing the exemplary forms and are not to be construed as limiting in nature.

[0178] Further, it should be appreciated that any one or more of the following forms, form expressions, examples, can be combined with any one or more of the other following forms, form expressions, and examples.

[0179] Various forms relate to improved ultrasonic and / or electrosurgical (RF) instruments configured for performing tissue treatment, dissection, cutting, and / or coagulation during surgical procedures. In one form, a combined ultrasonic and electrosurgical instrument can be configured for open surgical procedures, but also applies to other types of surgical procedures such as minimally invasive laparoscopic, visual or thoracoscopic procedures, e.g., non-invasive endoscopic procedures in hand-held or robotically assisted procedures. Multi-functionality is achieved by selectively applying multiple energy modalities simultaneously, independently, sequentially, or a combination thereof. For example, multi-functionality can be achieved by selectively using ultrasonic and electrosurgical energy (e.g., monopolar or bipolar RF energy) simultaneously, independently, sequentially, or a combination thereof.

[0180] In one aspect, the present disclosure provides an ultrasonic surgical clamping device comprising an ultrasonic blade and a deflectable RF electrode such that the ultrasonic blade and deflectable RF electrode cooperate to perform sealing, cutting, and clamping of tissue by the cooperation of the clamping mechanism of the device comprising the RF electrode and the associated ultrasonic blade. The clamping mechanism comprises a pivoting clamp arm that cooperates with the ultrasonic blade to grasp tissue therebetween. The clamp arm preferably has a clamping tissue pad (also referred to as a "clamp arm pad") having a plurality of axially spaced-apart clamping teeth, segments, elements, or individual units that cooperate with the ultrasonic blade of the end effector to achieve the desired sealing and cutting effects on tissue while facilitating grasping and clamping of tissue during a surgical procedure.

[0181] In one aspect, the end effectors described herein include an electrode. In other aspects, the end effectors described herein include alternative forms of electrodes to provide flexible coupling of RF energy to tissue, accommodate pad wear / thinning, minimize generation of excess heat (low coefficient of friction, pressure), minimize generation of sparks, minimize interruptions due to electrical shorts, or other combinations thereof. The electrode is fixed to the clamp jaw at a proximal end and is free to deflect at a distal end. Thus, throughout the present disclosure, the electrode can be referred to as a cantilevered beam electrode or deflectable electrode.

[0182] In other aspects, the end effectors described herein include a clamp arm mechanism configured to be able to apply high pressure between the pad and the ultrasonic blade to grasp and seal tissue, maximize the likelihood of the clamp arm electrode contacting tissue in restricted or difficult scenarios such as, for example, thin tissue, tissue under lateral tension, tissue tenting / vertical tension, especially when tented tissue is distanced from the clamp arm.

[0183] In other aspects, the end effectors described herein are configured to be able to balance the matching of surface area / current density between electrodes, balance and minimize heat conduction from tissue interfaces such as, for example, affecting lesion formation and symmetry, cycle time, residual thermal energy.

[0184] In other aspects, the end effectors described herein are configured to enable minimal adhesion, tissue adherence (minimal anchoring points) and can include small polyimide pads.

[0185] 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 movable jaw, a flexible 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 an ultrasonic generator. In various aspects, the end effector includes an electrode biasing mechanism.

[0186] In one general aspect, the present disclosure relates to a method of using a surgical device that includes a combination of ultrasonic and advanced bipolar RF energy and a movable RF electrode located on at least one jaw of an end effector. The movable RF electrode has a variable biasing force from a proximal end to a distal end of the movable RF electrode. The movable RF electrode is segmented into discrete portions and thus can be in electrical communication or isolated from one another. The movable RF electrode is made of a conductive or partially conductive material. It should be appreciated that any of the end effectors described in the present disclosure can be configured with an electrode biasing mechanism.

[0187] In one aspect, the present disclosure provides a limited electrode biasing mechanism to prevent damage to the electrode by the ultrasonic blade. Generally, in various aspects, the present disclosure provides an end effector for use with an ultrasonic / RF combination device, where the end effector includes an electrode. In one aspect, the combined ultrasonic / bipolar RF energy surgical device includes an electrode biasing mechanism. In one aspect, the limited electrode biasing mechanism is configured to prevent or minimize damage to the electrode by the ultrasonic blade. The electrode is fixed to the jaw at a proximal end and free to deflect at a distal end. Thus, throughout the present disclosure, the electrode can be referred to as a cantilevered beam electrode or a deflectable electrode.

[0188] In various aspects, the present disclosure provides a cantilevered electrode that is fixed at only one end that includes a biasing threshold mechanism. In one aspect, the deflectable cantilevered electrode is configured for use in a combined ultrasonic / bipolar RF energy surgical device.

[0189] In one aspect, a combined ultrasonic / RF energy surgical device includes an ultrasonic blade, a clamp arm, and at least one electrode passing through the ultrasonic blade. In one aspect, the electrode is configured to be deflectable relative to the clamp arm and includes a plurality of features for changing the mechanical properties of tissue under compression between the electrode and the ultrasonic blade. In another aspect, the electrode includes a feature that prevents accidental contact between the electrode and the ultrasonic blade to prevent or minimize damage to the electrode by the ultrasonic blade.

[0190] In various aspects, the electrode includes a metal spring element attached at a proximal end of a clamp jaw of an end effector. The metal spring element defines an opening for receiving one or more clamp arm pads (also referred to as "tissue pads" or "clamp tissue pads") therethrough and includes an integrated minimum gap element. This configuration of the electrode provides a method of preventing tissue buildup around the biasing mechanism, which can impact the performance of the electrode. The configuration also minimizes the binding between the wear pads and the biasing spring, enhances the strength of the electrode connection to the clamp arm, minimizes accidental release of the clamp arm pads by attaching the polyimide pads to the electrode, and achieves a balanced match of surface area / current density between the electrodes. The electrode is fixed to the clamp jaw at a proximal end and is free to deflect at a distal end. Thus, throughout this disclosure, the electrode is deflectable and can be referred to as a cantilevered beam electrode or deflectable electrode.

[0191] Figure 1 to Figure 9 One aspect of an end effector according to at least one aspect of the present disclosure is shown, including a deflectable / cantilevered electrode configured for use with a combined ultrasonic / bipolar RF energy device. Figure 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 aspect of the present disclosure. For brevity and clarity of the present disclosure, the ultrasonic blade, which serves as the other clamp arm of the end effector, is not shown. 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, causing the blade to break or short. Tissue being treated is clamped and compressed between the clamp arm 1000 and the ultrasonic blade.

[0192] The clamp arm 1000 includes a frame 1002, an electrode 1004, at least one non-conductive small gap pad 1006, at least one non-conductive large gap pad 1008, 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 enable setting 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 assist in sealing and cutting of the tissue. In other aspects, the non-conductive small gap pad and the non-conductive large gap pad are interchangeable. In other aspects, the non-conductive gap pads simply differ in size, regardless of the relative size difference between the non-conductive gap pads.

[0193] Pivoting movement of the clamp arm 1000 relative to the end effector is achieved by providing at least one (and preferably a pair of) lever portions 1012 of the frame 1002 of the clamp arm 1000 at its proximal end 1014. The lever portions 1012 are positioned on respective opposite sides of the ultrasonic waveguide and the end effector and are in operable engagement with the drive portion of the reciprocating actuation member. Reciprocating movement of the actuation member relative to the outer tubular sheath and the ultrasonic waveguide thereby effects pivoting movement of the clamp arm 1000 relative to the end effector about a pivot point 1016. The lever portions 1012 can be respectively positioned in a pair of openings defined by the drive portion, or otherwise suitably mechanically coupled therewith, whereby reciprocating movement of the actuation member acts through the drive portion and the lever portions 1012 to pivot the clamp arm 1000.

[0194] Figure 2 is in accordance with at least one aspect of the present disclosure Figure 1An exploded view of the clamp arm 1000 is shown. In various aspects, the electrode 1004 is made of a metal spring material that is attached to the proximal end 1014 of the frame 1002 of the clamp arm 1000 such that the electrode 1004 is deflectable. The metal spring electrode 1004 defines an opening 1018 for receiving an element of the clamp arm pad 1010 therethrough and defines additional openings 1020, 1021 for receiving gap pads 1006, 1008 to set a minimum gap between the electrode 1004 and the ultrasonic blade. At least one gap pad 1006 is disposed on a distal end 1022 of the electrode 1004. The gap pads 1006, 1008 are thus integrated with the electrode 1004. In this configuration, the electrode 1004 prevents tissue from accumulating around the biasing mechanism (e.g., cantilever spring), which can affect the performance of the electrode 1004. This configuration also minimizes the wear of the joint between the clamp arm pad 1010 and the biasing spring electrode 1004, enhances the strength of the electrode 1004 connection to the clamp arm, minimizes accidental release of the clamp arm pad 1018 by attaching the gap pads 1006, 1008 to the electrode 1004, and achieves a balanced match of surface area / current density between the electrodes. The electrode 1004 is attached to the frame 1002 by two tabs 1024. As Figure 3 and Figure 4 shown, the electrode tabs 1024 are attached to the proximal end 1014 of the frame 1002.

[0195] Figure 3 and Figure 4 are perspective views of the frame 1002 according to at least one aspect of the present disclosure. These figures 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 aspect, the electrode tabs 1024 are welded to the connection surface 1026 of the frame 1002 such that the electrode 1004 works in a deflectable manner.

[0196] Figure 5 is a perspective view of the electrode 1004 according to at least one aspect of the present disclosure. This figure shows the bias in the electrode 1004 made of a spring material as shown by the curvature of the electrode 1004 along the longitudinal length. The openings 1018, 1020, 1021 are for receiving the gap pads 1006, 1008 and the clamp arm pad 1010. In one aspect, the electrode 1004 has a thickness "d" of 0.010" and can be selected within a thickness range of, for example, 0.005" to 0.015". Reference is additionally made to Figure 8 and Figure 9 the size and configuration of the opening 1020 is set to receive a tab 1036 defined on a bottom portion of the gap pad 1006.

[0197] Figure 6is a perspective view of a clamp arm pad 1010 according to at least one aspect of the present disclosure. The clamp arm pad 1010 includes a plurality of clamp arm elements 1032 protruding from a main stem 1030. Throughout the present disclosure, the clamp arm elements 1032 are also referred to as "teeth." In one aspect, the clamp arm pad 1010 defines an aperture 1028 in a position where the gap pad 1006 is located on the electrode 1004. Reference is additionally made to Figure 8 and Figure 9 The size and configuration of the aperture 1028 defined by the clamp arm pad 1010 is set to receive the protrusion 1036 defined on the bottom portion of the gap pad 1006. In one aspect, the material of the clamp arm pad 1010 is softer than the material of the gap pads 1006, 1008. In one aspect, the clamp arm pad 1010 is made of a non-stick lubricious material, such as polytetrafluoroethylene (PTFE) or similar tetrafluoroethylene synthetic fluoropolymer. PTFE is a hydrophobic, non-wetting, high-density, and high-temperature-resistant, multi-purpose material and has non-stick properties. In contrast, the gap pads 1006, 1008 are made of a polyimide material, and in one aspect, for example, a durable high-performance polyimide-based plastic known by the trade name VESPEL and manufactured by DuPont, or other suitable polyimide, polyimide polymer alloy, or PET (polyethylene terephthalate), PEEK (polyether ether ketone), PEKK (polyether ketone ketone) polymer alloy. Unless otherwise noted below, the clamp arm pads and gap pads described below are made of the materials described in this paragraph.

[0198] Figure 7 is a perspective top view of a large gap pad 1008 according to at least one aspect of the present disclosure. The large gap pad 1008 includes a protrusion 1034 sized and configured to fit within an opening 1021 at the proximal end 1014 of the electrode 1004. Figure 8 is a perspective top view of a small gap pad 1006 according to at least one aspect of the present disclosure. Figure 9 is Figure 8 a perspective bottom view of the small gap pad 1006 as shown. As shown in Figure 8 and Figure 9 The small gap pad 1006 includes a protrusion 1036 at the bottom portion sized and configured to be received within the opening 1020 defined by the electrode 1004 and the aperture 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 aspect, a durable high-performance polyimide-based plastic known by the trade name VESPEL and manufactured by DuPont. The durability of the polyimide material ensures that the electrode gap remains relatively constant under normal wear and tear.

[0199] In one aspect, the present disclosure also provides additional end effector configurations for a combined ultrasonic and bipolar RF energy device. This section of the present disclosure provides end effector configurations for a combined ultrasonic and bipolar RF energy device. In these configurations, the end effector maintains a consistent gap between the RF electrode gap and the ultrasonic blade (which serves as one pole of the bipolar RF circuit) and the clamp arm (which serves as the opposite pole of the bipolar RF circuit). In traditional end effector configurations, the electrode gap is set by a soft PTFE clamp arm pad that can wear out during a procedure. When the clamp arm pad wears through, the ultrasonic blade can contact the electrode, causing blade breakage or electrical shorting, both of which are undesirable.

[0200] To overcome these and other limitations, aspects of the present disclosure employ a deflectable RF electrode in combination with a clamp arm pad comprising a non-stick, lubricious, flexible (e.g., PTFE) pad affixed to the clamp arm. The RF electrode comprises a wear-resistant, non-conductive pad that contacts the blade to set the blade-electrode gap. The flexible clamp arm pad extends through an opening defined by the electrode and reacts to clamping forces from the ultrasonic blade. As the flexible clamp arm pad wears, the electrode deflects to maintain a consistent gap between the blade and the electrode. This configuration provides a consistent gap between the electrode and the ultrasonic blade throughout the life of the device, prevents shorting and ultrasonic blade breakage that can occur when the ultrasonic blade contacts the electrode, and enables the electrode material to be positioned directly on the side opposite the ultrasonic blade to improve sealing performance. The electrode is fixed to the clamp jaw at the proximal end and is free to deflect at the distal end. Accordingly, throughout the present disclosure, the electrode can be referred to as a cantilevered beam electrode or a deflectable electrode.

[0201] In one aspect, the present disclosure provides an asymmetric fit of the clamp arm / electrode / pad to enable ultrasonic blade-RF electrode interaction. In one aspect, the present disclosure provides a shortened clamp arm. Figure 10 to Figure 12 An end effector comprising a shortened clamp arm suitable for deflectable / cantilevered electrode applications is shown in accordance with various aspects of the present disclosure. In one aspect, the end effector is configured for an asymmetric fit of the clamp arm, electrode, and clamp arm pad to enable ultrasonic blade / RF electrode interaction. The electrode is suitable for and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflecting under load, where the electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0202] In one aspect, the distal end of the clamp arm is shortened and the length of the clamp arm pad remains the same length such that the distal end of the clamp arm pad extends beyond the distal end of the clamp arm. This will allow the electrode to overextend to minimize the potential for electrical shorting at the distal end of the clamp arm. This can also have the beneficial effect of extending the life of the clamp arm pad as the otherwise exposed clamp arm pad material will be abraded away. This configuration can also eliminate the use of a distal and intermediate gap setting clamp arm pad, which has been previously referred to herein as, for example, an abradable clamp arm pad, for setting and maintaining a gap between the electrode and the ultrasonic blade.

[0203] Figure 10 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 aspect of the present disclosure. Figure 11 is a top view of the end effector 1680. As Figure 10 to Figure 11 shown, the length of the ultrasonic blade 1684 and the electrode 1686 are substantially the same. The clamp arm 1682 is shortened to allow the electrode 1686 to overextend to prevent electrical shorting. In one aspect, a gap setting pad 1690 is provided at the proximal end 1692 of the end effector 1680.

[0204] Figure 12 is shown a clamp arm 1700 including a clamp jaw 1702, an electrode 1704, and a clamp arm pad 1706 according to at least one aspect of the present disclosure. The distal space of the clamp arm is freed up. The clamp arm 1700 is configured for use with an end effector including an ultrasonic blade as disclosed in other sections herein. This configuration frees up the distal space 1708 on the clamp jaw 1702. The clamp arm pad 1706 (e.g., PTFE) is fully supported underneath, but the space in the t-slot region and on the sidewalls is freed up to allow more of the clamp arm pad 1706 to burn through and the electrode 1704 to deflect further away from the ultrasonic blade (not shown).

[0205] In one aspect, the present disclosure provides an end effector that utilizes the thermal behavior of a pad to deflect an electrode. In one aspect, the length of the clamp arm pad can be the same length as the length of 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 used to deflect the electrode out of the path of the ultrasonic blade.

[0206] In one aspect, a non-biased electrode and pad are provided. As the pad wears, the non-biased but deflectable pad changes position relative to the clamp arm. The non-biased electrode is configured to enable minimization of contact between the ultrasonic blade and the RF electrode. The clamp arm pad includes features for securing the electrode to the clamp arm pad. In one aspect, as the height of the clamp arm pad wears or is cut through, the height of the electrode relative to the clamp arm is adjusted in a progressive manner. In another aspect, once the clamp arm is moved away from the ultrasonic blade, the electrode remains in its new position. The electrode is fixed to the clamp arm at the proximal end and free to deflect at the distal end. Thus, throughout this disclosure, the electrode can be referred to as a cantilevered electrode or deflectable electrode.

[0207] The end effector including the deflectable / cantilevered electrode described above in relation to Figure 1 to Figure 12 may be combined with the biased electrode described below in relation to Figure 13 to Figure 18 .

[0208] In one aspect, the present disclosure provides an end effector for a combined ultrasonic / bipolar RF energy surgical device that employs pressure or clamp compression to adjust the height of the electrode as the clamp arm pad wears. In one aspect, the clamp arm pad follows a clamp arm biased electrode with an abradable stop. In one aspect, the clamp arm pad includes features for securing the electrode to the pad. As the height of the pad wears or is cut through, the height of the electrode relative to the clamp arm is adjusted in a progressive manner. Once the clamp arm is moved away from the ultrasonic blade, the electrode remains in its new position.

[0209] Achieving sufficient clamp arm pad life on a combined ultrasonic / bipolar RF energy surgical device requires maintaining a clamp arm pad-electrode gap that is sufficiently small but non-zero throughout the life of the instrument to provide the desired ultrasonic and bipolar RF tissue effects. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflecting under load, where the electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0210] The existing (seed) electrode is a flat electrode that is actually horizontal or parallel to the clamp arm in the free state (no load). The electrode is fixed to the clamp arm at the proximal end and free to deflect at the distal end. Thus, throughout this disclosure, the electrode can be referred to as a cantilevered electrode or deflectable / cantilevered electrode. When clamped on tissue, the tissue exerts a load on the electrode, causing it to deflect toward the clamp arm.

[0211] In one aspect, as the pad wears, the electrode "follows" the pad. In this aspect, the electrode is biased toward the free state of the clamp arm using any suitable fastening technique, such as welding, laser welding, brazing, soldering, pressing, and other fastening techniques (whether by forming / bending the electrode, or by attaching / welding the electrode non-parallel to the clamp arm). Worn stop features (on the pad or elsewhere) keep the electrode away from the clamp arm until they are worn away during use. Once worn away, the electrode is able to access the clamp arm. These features can be tooth or ratchet shaped, vertical tapering, or other.

[0212] In one aspect, the present disclosure provides a deflectable / cantilevered electrode, where in the free state, the electrode is biased toward the clamp arm and can be attached at an angle and made into a pre-shaped curve using any suitable fastening technique, such as welding, laser welding, brazing, soldering, pressing, and other fastening techniques.

[0213] In one aspect, the present disclosure provides an end effector with a deflectable / cantilevered electrode that includes a wear-away stop feature to prevent the electrode from reaching or contacting the clamp arm. As the stop feature wears away, the electrode moves toward the clamp arm until it reaches the next stop. In one aspect, the stop feature wears away simultaneously with the clamp arm pad to maintain the proper gap between the clamp arm pad and the electrode. These features can be completely separate from the clamp arm pad. These features can be configured to withstand the clamp load but be worn away due to heat (melting / flowing) or abrasion. 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).

[0214] Figure 13 An end effector clamp arm 1710 including a jaw 1712, an electrode 1714, and a clamp arm pad 1716 is shown in accordance with at least one aspect 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 the present disclosure. The clamp arm 1710 further includes a wear gap pad 1717 to set a gap between the electrode 1714 and the ultrasonic blade. As shown, in the free state, the electrode 1714 is biased in a flat or horizontal orientation 1718. The electrode 1714 is fixed to the jaw 1712 at a proximal end and is free to deflect at a distal end. Accordingly, throughout the present disclosure, the electrode 1714 can be referred to as a cantilevered beam electrode or a deflectable electrode.

[0215] Figure 14An end effector clamp arm 1720 including a clamp jaw 1722, an electrode 1724, and a clamp arm pad 1726 is shown in accordance with at least one aspect 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 the present disclosure. The clamp arm 1720 further includes a wear gap pad 1727 to set a gap between the electrode 1724 and the ultrasonic blade. As shown, in a free state, the electrode 1724 is configured to be pre-shaped, curved, or otherwise biased away from the horizontal 1718 toward the clamp jaw 1722 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. Accordingly, throughout the present disclosure, the electrode 1724 can be referred to as a cantilevered beam electrode or a deflectable electrode. To prevent the biased electrode 1724 from bending toward the clamp jaw 1722 under the biasing force, the clamp arm 1720 further includes a retainer to prevent the biased electrode 1724 from bending toward the clamp jaw 1722 and to maintain the biased electrode 1724 in a generally flat 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 in Figure 15 to Figure 18

[0216] Figure 15 An end effector clamp arm 1730 including a clamp jaw 1732, an electrode 1734, and a clamp arm pad 1736 is shown in accordance with at least one aspect 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 the present disclosure. The clamp arm 1730 further includes a wear gap pad 1737 to set a gap between the electrode 1744 and the ultrasonic blade. In a free state, the electrode 1734 is configured to be pre-shaped curved, bent, or otherwise biased toward the clamp jaw 1732. However, retainer teeth 1738 or similar features are provided on the clamp arm pad 1736 to prevent the electrode 1734 from snapping toward the clamp jaw 1732. In Figure 16

[0217] Figure 17 ​​An end effector clamp arm 1750 including a clamp jaw 1752, an electrode 1754, and a clamp arm pad 1756 is shown in accordance with at least one aspect 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 the present disclosure. The clamp arm 1750 further includes a wear gap pad 1757 to set a gap between the electrode 1754 and the ultrasonic blade. In a free state, the electrode 1754 is configured to be pre-shaped with a curve, kinked, or otherwise biased 1758 toward the clamp jaw 1752. However, a retainer wall 1760 or similar feature with a tapered profile is provided on the clamp arm pad 1756 to prevent the electrode 1754 from springing in toward the clamp jaw 1752.

[0218] In Figure 17 In accordance with at least one aspect of the present disclosure, when the tapered profile retainer wall 1760 is worn away, there is sufficient melt / flow away from the area of the tapered profile retainer wall 1760 to allow the electrode 1754 to move toward the clamp jaw 1752 due to the pre-shaped curve. The electrode 1754 is fixed to the clamp jaw 1752 at a proximal end and free to deflect at a distal end. Accordingly, throughout the present disclosure, the electrode 1754 can be referred to as a cantilevered beam electrode or deflectable electrode.

[0219] In one aspect, the present disclosure provides an end effector for a combined ultrasonic / bipolar RF energy surgical device that employs a constant pressure distribution biasing mechanism. In one aspect, the end effector includes a resiliently compressible support for mounting a deflectable electrode and insulating the deflectable electrode. In one aspect, a hollow honeycomb or chambered elastomeric support attachment pad can be employed to allow all or part of the electrode attached thereto to deflect but be biased toward the ultrasonic blade. This configuration can provide the additional benefit of thermally insulating the electrode from the rest of the metal clamp jaw. This will also provide an elastomeric "curtain" around the electrode to minimize tissue build-up behind the electrode. In one aspect, the non-strutted elastomeric unit suitable deflectable geometry will cause the deflection force to remain constant over a predetermined deflection range. The electrode is suitable for and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflecting under load, where the electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0220] The above configuration prevents the electrode from laterally deflecting under compression to prevent shorting. In addition, the deflectable electrode is attached to an elastomer and the elastomer is attached to a metal clamp arm. The physical height of the spring is limited by the amount of compression allowed by the drive, while maintaining as much metal clamp arm as possible. Heat conduction from the tissue interface is balanced and minimized - affecting lesion formation and symmetry, cycle time, and residual thermal energy.

[0221] The above configuration prevents the electrode from laterally deflecting under compression to prevent shorting. In addition, the deflectable electrode is attached to an elastomer and the elastomer is attached to a metal clamp arm. The physical height of the spring is limited by the amount of compression allowed by the drive, while maintaining as much metal clamp arm as possible. Heat conduction from the tissue interface is balanced and minimized - affecting lesion formation and symmetry, cycle time, and residual thermal energy.Figure 1 to Figure 12 The configuration of the end effector described above with respect to Figure 19 to Figure 21 may be combined with a flexible electrode disposed above a mesh spacer and a plurality of hard spacers to set a gap between the flexible electrode and the ultrasonic blade as described below with respect to .

[0222] The configuration of the bias electrode described above with respect to Figure 13 to Figure 18 may be combined with a flexible electrode disposed above a mesh spacer and a plurality of hard spacers to set a gap between the flexible electrode and the ultrasonic blade as described below with respect to Figure 19 to Figure 21 .

[0223] The configuration of the end effector comprising the combination of the deflectable / cantilevered electrode described above with respect to Figure 1 to Figure 12 and the bias electrode described above with respect to Figure 13 to Figure 18 may be combined with a flexible electrode disposed above a mesh spacer and a plurality of hard spacers to set a gap between the flexible electrode and the ultrasonic blade as described below with respect to Figure 19 to Figure 21 .

[0224] Figure 19 to Figure 20 An end effector 1810 is shown in accordance with at least one aspect of the present disclosure comprising a clamp arm 1812, an ultrasonic blade 1814, a mesh spacer 1816, a flexible electrode 1818 disposed above the mesh spacer 1816, and a plurality of hard spacers 1820 to set a gap between the flexible electrode 1818 and the ultrasonic blade 1814. Figure 21 is Figure 19 to Figure 20 an exploded view of the end effector 1810. A clamp arm pad 1822 is disposed within a slot 1825 formed within the mesh spacer 1816. The mesh spacer 1816 acts as a spring-like element. The hard spacers 1820 are used to set the gap between the flexible electrode 1818 and the ultrasonic blade 1814.

[0225] In Figure 19 , the clamp arm 1812 is open and the tissue 1824 of uneven thickness (T 1a , T 2a , T 3a ) is disposed above the flexible electrode 1818. In Figure 20 , the clamp arm 1812 is closed to compress the tissue 1824. The mesh spacer 1816 on the clamp arm 1812 results in uniform tissue 1824 (T 1b , T 2b , T 3b ) compression on the tissue 1824 of variable thickness (T 1a , T 2a , T 3a ) such that:

[0226]

[0227] Further background information can be found in EP3378427 and WO2019 / 006068, the full text of which is incorporated herein by reference.

[0228] In one aspect, this disclosure provides an end effector for a combined ultrasound / bipolar RF energy surgical device having means for ensuring distal end contact with a bias using a zero-gap bipolar RF energy system. In various aspects, this disclosure provides a deflectable electrode for a combined ultrasound / bipolar RF energy surgical device having a greater distal bias than a proximal bias. In one aspect, this disclosure provides a combined energy device including a bipolar electrode capable of deflecting relative to a clamping arm. The combined energy device includes features that alter the mechanical properties of tissue compression from proximal to distal to produce a more uniform or different pressure pattern than that produced by clamping alone. In one aspect, this disclosure provides a nonlinear distal distribution mechanism, and in another aspect, this disclosure provides an electrically nonlinear distribution of energy density. Electrodes are adapted and configured for use with a combined ultrasound / bipolar RF energy surgical device and are capable of deflection under load, wherein the electrode is one pole of a bipolar RF circuit and the ultrasonic scalpel is the opposite pole of the bipolar RF circuit.

[0229] Including the above about Figure 1 to Figure 12 The configuration of the end effector of the deflectable / cantilever electrode can be similar to that described below. Figure 22 to Figure 36 The aforementioned conductive polymer clamping arm pad assembly.

[0230] As mentioned above Figure 13 to Figure 18 The configuration of the bias electrode can be similar to that described below. Figure 22 to Figure 36 The aforementioned conductive polymer clamping arm pad assembly.

[0231] Flexible electrodes positioned above the mesh pad and as described above Figure 19 to Figure 21 The configuration of the plurality of rigid spacers used to create a gap between the flexible electrode and the ultrasonic scalpel can be similar to the following description. Figure 22 to Figure 36 The aforementioned conductive polymer clamping arm pad assembly.

[0232] As mentioned above Figure 13 to Figure 18 The configuration of the bias electrode can be combined with a flexible electrode disposed above the grid pad, and as described above regarding Figure 19 to Figure 21 The plurality of rigid spacers used to create a gap between the flexible electrode and the ultrasonic scalpel can be related to the following text. Figure 22 to Figure 36 The aforementioned conductive polymer clamping arm pad assembly.

[0233] As mentioned above Figure 13 to Figure 18The configuration of the bias electrode can be combined with a flexible electrode disposed above the grid pad, and as described above regarding Figure 19 to Figure 21 The plurality of rigid spacers used to create a gap between the flexible electrode and the ultrasonic scalpel can be related to the following text. Figure 22 to Figure 36 The aforementioned conductive polymer clamping arm pad assembly.

[0234] Including the above about Figure 1 to Figure 12 The deflectable / cantilever electrode mentioned above is related to the above. Figure 13 to 18 The configuration of the end effector with the aforementioned combination of bias electrodes is similar to that described below regarding... Figure 22 to Figure 36 The aforementioned conductive polymer clamping arm pad assembly.

[0235] Including the above about Figure 1 to Figure 12 The deflectable / cantilever electrode mentioned above is related to the above. Figure 13 to Figure 18 The configuration of the end effector with the aforementioned combination of bias electrodes can be combined with flexible electrodes disposed above the mesh pad, and as described above regarding Figure 19 to Figure 21 The plurality of rigid spacers used to create a gap between the flexible electrode and the ultrasonic scalpel can be related to the following text. Figure 22 to Figure 36 The aforementioned conductive polymer clamping arm pad assembly.

[0236] In various aspects, this disclosure provides a combined ultrasonic / bipolar RF energy surgical device comprising an ultrasonic pad having partially or fully conductive portions, such that the ultrasonic pad serves as both a scalpel support / wearing pad and a bipolar RF electrode. In one aspect, this disclosure provides a partially conductive clamping arm pad capable of abrading the electrode and minimizing short circuits in the combined bipolar RF and ultrasonic energy device, wherein the clamping arm pad has conductive and non-conductive portions, thereby allowing it to function as one electrode among the RF electrodes while also serving as an abrasive support structure for the ultrasonic scalpel. In another aspect, this disclosure provides a conductive portion surrounding the periphery of the clamping arm pad and not directly positioned on a side opposite the ultrasonic scalpel contact area. In yet another aspect, a portion of the conductive clamping arm pad is degradable or abrasive to prevent contact from the ultrasonic scalpel from interrupting the conductivity of the remaining portion of the conductive clamping arm pad.

[0237] In one aspect, this disclosure provides an end effector for a combined ultrasound / bipolar RF energy surgical device, the end effector comprising a conductive polymer ultrasound gripping arm pad. In another aspect, the end effector comprises a gripping arm pad doped with tin oxide. Figure 22is 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 includes tin oxide 2442 (Sn02) embedded in a polymer material 2444 such as polytetrafluoroethylene (PTFE) to make the clamp arm pad 2440 electrically conductive. Doping can be achieved using a cold spray process. Once doped, the conductive polymer clamp arm pad 2440 can achieve traditional ultrasonic tissue clamp arm pad functions such as, for example, contacting the ultrasonic blade, absorbing heat from the ultrasonic blade, and assisting in tissue grasping and clamping. The doped tin oxide clamp arm pad 2440 functions as one of the two electrodes or poles of a bipolar RF circuit to deliver RF energy to tissue grasped between the ultrasonic blade and the clamp arm pad 2440. The doped tin oxide clamp arm pad 2440 is biocompatible, electrically conductive, thermally conductive, such that a majority of the clamp arm pad 2440 can be used 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, where the electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0238] In one aspect, the present disclosure provides a conductive polymer ultrasonic clamp arm pad as an electrode substitute. To extend the life of an ultrasonic clamp arm pad and improve RF tissue effects, the present disclosure provides an improved, easier to manufacture, and less expensive electrode. In one aspect, the present disclosure provides a clamp arm pad comprising a hard polyimide polymer layer and a conductive layer to allow the clamp arm pad to achieve traditional functions and carry bipolar electricity, thereby combining the clamp arm of an energy end effector no longer requiring a separate electrode. As such, the forceps can be manufactured in a manner similar to a pure ultrasonic forceps, where the new clamp arm pad material is interchangeable with a traditional pure ultrasonic 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, where the electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0239] Benefits include improved ultrasonic performance, including clamp arm pad wear, similar to current pure ultrasonic instruments, as there are no electrode gaps between the elements "squares" of the polymer. The cost of the improved forceps will be similar to current pure ultrasonic forceps due to the elimination of a separate electrode component and the provision of multiple small polymer square elements. Additionally, the manufacturing steps required to manufacture the forceps are the same as those required to manufacture current pure ultrasonic forceps. Manufacturing the improved forceps only requires replacement of the clamp arm pad and does require production of additional electrode components to add to the forceps and eliminates an assembly step.

[0240] Figure 23is a perspective view of a clamp arm pad 2450 configured to be able to replace a conventional electrode according to at least one aspect of the present disclosure. The clamp arm pad 2450 includes a sandwiched configuration of a non-conductive layer 2452 and a conductive layer 2454. This configuration eliminates the need for a spring-loaded electrode plate. The non-conductive layer 2452 can be made of a polymer, polyimide, polytetrafluoroethylene (PTFE), and similar non-conductive materials. The conductive layer 2454 can be made of a thin conductive polymer, a metal foil, or a carbon-loaded material. The clamp arm pad 2450 can be manufactured such that a majority of the material that contacts the ultrasonic blade is the non-conductive layer 2452. In one aspect, 75% of the material that contacts the ultrasonic blade is a non-conductive material, such as PTFE. In another aspect, 85% of the material that contacts the ultrasonic blade is a non-conductive material, such as PTFE. In another aspect, 95% of the material that contacts the ultrasonic blade is a non-conductive material, such as PTFE. Additionally, as the clamp arm pad 2450 wears, the conductive layer 2452 will still have available surface area to conduct RF power through the tissue and return electrode (e.g., ultrasonic blade).

[0241] Figure 24 is shown a clamp arm 2460 including the clamp arm pad 2450 as described Figure 23 in accordance with at least one aspect of the present disclosure. The non- conductive layer 2452 has a large surface area compared to the conductive layer 2454, which appears as a thin layer or foil.

[0242] Figure 25 is shown a clamp arm pad as described in Figure 23 to Figure 24 the first clamp arm pad 2470 is new and includes teeth 2472 integrally formed therewith. The second clamp arm pad 2476 is new but does not have teeth. The third clamp arm pad 2478 is worn and can represent either the first clamp arm pad 2470 or the second clamp arm pad 2476.

[0243] In one aspect, the present disclosure provides a composite clamp arm pad for a combined ultrasonic / bipolar RF energy surgical device. Figure 26is a cross-sectional view of a clamp arm 2480 including 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 jaw 2486 and an adhesive 2488 to fixedly attach the composite clamp arm pad 2482 to the upper jaw 2486. The composite clamp arm pad 2482 includes a thin electrically non-conductive layer 2490 (e.g., PTFE) and a thin electrically conductive layer 2492 (e.g., thin stainless steel foil). The electrically conductive layer 2492 forms an electrode portion of the composite clamp arm pad 2482. As the electrically non-conductive layer 2490 (e.g., PTFE) is worn away, the electrically conductive layer 2492 (e.g., thin stainless steel foil) deforms. The thickness of the electrically conductive layer 2492 enables the electrode portion of the composite clamp arm pad 2482 to deform as the electrically non-conductive layer 2490 is worn away. Advantageously, the electrically conductive layer 2492 conducts some heat away from the electrically non-conductive layer 2490 to keep the composite clamp arm pad 2482 cooler. As described above, the composite clamp arm pad 2482 is fixed to the upper jaw 2486 by the adhesive 2488. The adhesive 2488 can be filled with carbon to make it electrically conductive and connect the electrode portion of the composite clamp arm pad 2482 to the upper jaw 2486. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflecting under a 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.

[0244] In one aspect, the clamp arm pad includes a cooperating electrically conductive portion and an insulating portion. In one aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device, where the clamp arm pad has an electrically conductive portion and an electrically non-conductive portion, allowing it to function as one of the RF electrodes, while also functioning as an abradable support structure for the ultrasonic blade. In another aspect, the electrically conductive portion of the clamp arm pad is disposed around the perimeter of the pad and is not positioned directly on the side opposite the area of contact with the ultrasonic blade. In another aspect, the electrically conductive portion of the clamp arm pad is degradable or abradable to prevent contact with the ultrasonic blade from interrupting the electrical conductivity of the remaining electrically conductive portion of the clamp arm pad.

[0245] In one aspect, the present disclosure provides a clamp arm pad for use with a combined ultrasonic / bipolar RF energy device, where a portion of the clamp arm pad includes an electrically conductive material and other portions include electrically non-conductive material. The electrode is adapted and configured for use with a combined ultrasonic / RF energy device and is capable of deflecting under a 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.

[0246] Various techniques can be used to manufacture clamping arm pads in various aspects. One technique involves a secondary injection molding process that molds conductive and non-conductive materials in the same mold. This process effectively forms a single clamping arm pad having parts that can be used as bipolar RF electrodes and other parts that will be used as electrical insulators. Another technique involves ultrasonically cold-spraying metallic elements into polymer (e.g., PTFE) pads or matrices. Another technique involves 3D printing of multiple materials (e.g., PTFE and doped conductive polymers) to print / transfer conductive or functional inks onto the clamping arm pad. Another technique involves applying metals and conductive materials (e.g., graphite / carbon) to the clamping arm pad using chemical vapor deposition, physical vapor deposition, sputtering deposition, vacuum deposition, vacuum metallization, or thermal spraying. Yet another technique involves conductive / loaded clamping arm pad electrodes providing continuity through pads with microscopically randomized and positioned particles or macroscopically oriented structures (e.g., fabrics, braids, length-constrained fibers). Another technology includes making the surface of the clamping arm pad conductive, providing through-hole electrodes, 3D printing, thermal spraying, cold spraying, coating / paint / epoxy resin, sheet / foil / wire / film winding or lamination, vacuum metallization, printing / transfer, etc. In another technology, the polymer electrodes are filled with conductive material.

[0247] In one aspect, the end effector gripper arm includes a fixed polymer electrode. Figure 27 A clamping arm 2500 according to at least one aspect of the present disclosure is shown, the clamping arm including a clamp 2502 for supporting a bracket 2504 or a stamped part attached to a clamp 2502, and a clamping arm pad 2506. The clamping arm pad 2506 includes 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 in a bipolar RF circuit. The clamp 2502 and the bracket 2504 may be made of stainless steel and attached using any suitable fastening technique, such as, for example, welding, laser welding, brazing, soldering, pressing, and other fastening techniques. The conductive pad 2508 may comprise a polymer, such as, for example, silicone, fluorosilicone, PTFE, and similar materials. The conductive pad 2508 is overmolded onto the support 2504 using PTFE, silicone resin, fluorosilicone resin filled with silver particles, silver-plated aluminum, silver-plated copper, copper, nickel, graphite, carbon (amorphous, chopped fiber), gold, platinum, stainless steel, iron or zinc, or combinations thereof.

[0248] Figure 28 It is along Figure 27 The sectional view taken from section 28-28 in the middle, and Figure 29 It is along Figure 27 The sectional view taken from section 29-29. Figure 28-28And 29-29 shows a clamp arm 2500 including a clamp jaw 2502, a support bracket 2504, a conductive pad 2508, and a non-conductive pad 2510.

[0249] Figure 30 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 aspect of the present disclosure. The conductive pad 2524 is made of a conductive polymer and functions as one of the electrodes of a bipolar RF circuit.

[0250] Figure 31 is a cross-sectional view of an alternative implementation of a clamp arm 2530 including a clamp jaw 2532, a bracket 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 aspect of the present disclosure. The conductive pad 2536 is made of a conductive polymer and functions as one of the electrodes of a bipolar RF circuit. The conductive pad 2536 is overmolded or stamped onto the bracket 2534.

[0251] In one aspect, the end effector clamp arm includes a film over metal insert molded electrode assembly. In one aspect, a film can be provided over a metal (e.g., stainless steel) insert molded electrode assembly. The film over metal such as stainless steel can form the electrode assembly in an insert molded manner. The film on the insert molded electrode can be etched to form micro-holes, slits, honeycombs, and other patterns to enable the conduction of RF energy as well as the cutting of the periphery of the part. The film can be formed on or bonded to the stainless steel electrode using the IML / FIM (in-mold labeling / film insert molding) process described below. The live film electrode can be placed in a polymer injection mold to mold the polymer to 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 capable of deflection 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.

[0252] Figure 32 shows an insert molded electrode 2540, in accordance with at least one aspect of the present disclosure. The insert molded electrode 2540 includes a conductive element 2546, a molded polymer pad 2548, and a film 2542 coating. Features 2550 such as micro-holes, slits, honeycombs, or similar features are formed in the film 2542 to allow the passage of RF energy. Retention features 2552 are also formed on the film 2542. The sidewalls 2558 of the film 2542 that extend below the bottom of the polymer pad 2548 can be folded around the bottom of the polymer pad 2548 and overmolded with the retention posts. The retention features 2552 are molded into the holes 2554 defined by the film 2542. Although shown with a gap between the two insert molded electrodes 2540, in practice, the two insert molded electrodes 2540 mate via the molded pressure lines on line 2556.

[0253] The conductive element 2546 can be made of a conductive metal such as stainless steel or similar conductive material. The conductive element 2546 can be about 0.010" thick and can be selected within a range of 0.005" to 0.015" thick and can be formed by ramming or machining. The film 2544 can be about 0.001" to 0.002" thick and can be made of polyimide, polyester or similar material. The film 2544 can be bonded directly to the conductive element 2546 as an alternative to mechanical retention such as a post. One example includes a DuPont Pyralux HXC Kapton film with epoxy adhesive backing that is 0.002" thick.

[0254] Advantageously, the non-stick surface prevents tissue adhesion to the insert molded electrode 2540. By providing a gap in the range of 0.002" to 0.004" along the entire length of the insert molded electrode 2540, the non-stick surface avoids shorting of the opposing electrode. The non-stick surface minimizes lateral propagation of RF energy due to the coverage of the sidewall 2558 of the insert molded electrode 2540. In addition, the insert molded electrode 2540 exhibits structural robustness and provides an easier and more robust electrical connection than a multi-layer flexible circuit.

[0255] In one aspect, the end effector includes a conductive clamp arm and pad configuration for a combined ultrasonic / bipolar RF energy surgical device. In one aspect, the present disclosure provides a clamp arm assembly including a conductive or selectively conductive film, foil or laminate applied to, around or on the clamp arm assembly for use as a durable "pole" in a combined ultrasonic / bipolar RF energy surgical device. Further, an algorithm, software or logic is provided to manage the condition of electrical shorting. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflection under load, wherein the electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0256] Figure 33 An end effector 2560 is shown including an ultrasonic blade 2562, a clamp arm 2564 and a clamp arm pad 2566 containing a conductive film 2568 in accordance with at least one aspect of the present disclosure.

[0257] Figure 34 An end effector 2560 is shown including an ultrasonic blade 2562, a clamp arm 2564 and a clamp arm pad 2566 containing a conductive film 2568 in accordance with at least one aspect of the present disclosure. Figure 33 The clamp arm 2564 is shown. The clamp arm 2564 includes a jaw 2570 to support the clamp arm pad 2566. A thin conductive film 2568 is disposed on the clamp arm pad 2566 to form an electrode of one of the poles of a bipolar RF circuit.

[0258] Figure 35 is along Figure 34A cross-sectional view of the clamp arm 2564 taken at section 35-35 in FIG. 35. The clamp jaw 2570 can be made of a metal such as stainless steel. The clamp arm pad 2566 can be made of a non-conductive flexible material such as PTFE, silicone, high temperature polymer, or similar material. The conductive film 2568 or foil can be made of a conductive material such as titanium, silver, gold, aluminum, zinc, and any alloys thereof, including stainless steel.

[0259] Figure 36 A clamp arm 2580 including a partially conductive clamp arm pad 2582 is shown in accordance with at least one aspect of the present disclosure. A conductive foil 2584 covers a portion of a non-conductive pad 2586. A non-conductive pad 2588 at a proximal end 2590 provides a gap between the clamp arm pad 2582 and the ultrasonic blade.

[0260] The conductive film 2568, foil, or laminate element can comprise, for example, a single layer of thin conductive material such as a metal (titanium, silver, gold, zinc, aluminum, magnesium, iron, etc. and alloys or stainless steel thereof), a plated metal (e.g., nickel first, then gold over copper), or a polymer heavily filled with a conductive material such as a metal powder or filler. Preferably, it is a biocompatible metal foil having a thickness selected from the range of 0.001" to 0.008" (0.025 mm to 0.20 mm), such as titanium, silver, gold, zinc, or stainless steel.

[0261] The film 2568, foil, or laminate can include a thin polymer coating, film, or layer overlying the thin conductive material described above. Such a coating, film, or layer is highly resistive, i.e., it is not an effective conductor of bipolar RF energy to adjacent tissue. The coating can be perforated to allow energy to be delivered from the electrode to tissue.

[0262] The conductive material can be perforated or include holes or windows through the full thickness of the conductive material to minimize the thermal capacity of the layer (testing has shown that long and / or thick foils result in longer transection times due to the removal of thermal energy from the treatment line of sight). These perforations, holes, or windows can also allow the foil to be held to other portions or layers. These perforations, holes, or windows can be patterned across the foil sheet, or can be positioned at or away from the treatment site, such as, for example, only on the sides of the clamp arm.

[0263] The thin polymer coating, film, or layer, if present, can be perforated or include holes or windows through the full thickness such that the conductive film, foil, or laminate is in direct communication with tissue for delivery of bipolar radiofrequency energy to the tissue. For a coating, these holes or windows can be formed by selective coating or coating removal.

[0264] Ideally, the conductive film 2568, foil, or laminate is in direct contact with the clamp arm structure, which is typically fabricated from stainless steel. The resulting conductive path then enables simplicity of construction, as the path is formed by the necessary structural components, i.e., the support tube or actuator that is directly connected to the clamp arm and then to the conductive film, foil, or laminate.

[0265] In one aspect, the conductive film 2568, foil, or laminate is supported by a relatively soft, high temperature, low wear polymer or elastomeric pad made from materials such as PTFE, silicone, polyimide, high temperature thermoplastics, and others. The compliance of this relatively soft pad allows for a wide range of component tolerances to achieve zero or near zero gap between the clamp and ultrasonic blade along its entire tissue-acting length when the clamp is fully closed, enabling sealing and cutting of tissue along this length. Compliance also eliminates or greatly attenuates any audible vibrations of the conductive layer that can occur when the ultrasonic blade is in close proximity to the conductive layer.

[0266] The conductive film 2568, foil, or laminate can include a rigid to semi-rigid polymer on its backside / back surface (i.e., the surface that is away from the tissue and toward the clamp arm). This component is made from a polymer or polymer alloy that can be injection molded and adhered to the film, foil, or laminate by film insert molding (FIM) or in-mold labeling (IML).

[0267] In testing, thin stainless steel, copper, or aluminum foil was quiet (no "squealing" or emitting a dull squeal) in operation. Thin stainless steel, copper, or aluminum foil provided a solid surface against which the ultrasonic blade could act. Solid enough that materials such as silicone rubber, which would otherwise tear and serve as a poor pad material, were usable and not prone to tearing or splitting.

[0268] The proximal portion of the clamp gripping surface can not include a conductive film, foil, or laminate, as this area of the clamp first contacts the blade and is more likely to cause a power shunt / short in this area.

[0269] In one aspect, the present disclosure provides a short circuit mitigation algorithm for activating an output comprising bipolar RF energy.

[0270] A short circuit alert is not given to the user after a short circuit occurs if the energy delivered for activation exceeds a threshold amount (indicating tissue thinning but possibly having received a sufficient dose of bipolar RF energy for sealing, coagulation of tissue), or an activation time threshold has been exceeded (again, indicating tissue thinning but possibly having received a sufficient dose), or both the energy threshold and the activation time threshold have been exceeded.

[0271] The process of making a film-coated stainless steel insert molded electrode assembly includes: etching the film and forming holes (micropores, slots, or honeycombs) for the transmission of RF energy; cutting the perimeter of the electrode component; forming the film on the stainless steel electrode if needed / bonding the film to the stainless steel electrode; placing the charged film and electrode in a polymer injection mold; molding the polymer to the back of the electrode and film.

[0272] In various aspects, the present disclosure provides a combination ultrasonic / bipolar RF energy surgical device configured to control tissue sticking, charring, and / or tissue sticking to the clamp arm, ultrasonic blade, or electrode. In one aspect, the clamp arm jaws are configured with features or aspects to minimize tissue sticking to the end effector components and improve tissue control. In one aspect, a tissue path or clamp arm region control feature is provided to adjust the tissue path relative to the clamp arm / ultrasonic blade to create a predetermined contact location to reduce tissue sticking to the clamp arm or ultrasonic blade and charring of tissue due to over heating or prolonged application of heat.

[0273] In one aspect, the end effector includes side guards to prevent tissue from accumulating on the end effector components. In one aspect, the end effector includes a tissue path or clamp arm region control feature to adjust the tissue path relative to the clamp arm / blade to create a predetermined contact location. The control feature is configured to reduce tissue sticking to the end effector elements such as the clamp arm jaws, clamp arm pads, or ultrasonic blade and tissue charring.

[0274] In one aspect, the present disclosure provides a clamp arm having raised side walls or guards to surround the electrode to prevent exposure and prevent tissue from entering the area inside the side walls. In one implementation, the side walls of the clamp arm can be extruded around the clamp arm pads to a degree but not enough to cause tissue to begin to fold over. The electrode is adapted and configured for use with a combination ultrasonic / bipolar RF energy surgical device and is capable of deflecting under load, where the electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0275] Figure 37 A clamp arm 2620 is shown that includes jaws 2622, a clamp arm pad 2624 having exposed teeth 2626 in accordance with at least one aspect of the present disclosure. The exposed teeth 2626 prevent tissue from entering the area inside the exposed teeth 2626.

[0276] Figure 38A clamp arm 2630 is shown according to at least one aspect of the present disclosure, including a jaw 2632 having a raised sidewall 2634 and a raised lip 2636 and a clamp arm pad 2638 having a plurality of teeth 2639. The raised sidewall 2634 and the raised lip 2636 prevent tissue from accumulating inside 2637 the sidewall 2634 and the raised lip 2636.

[0277] In one aspect, the present disclosure provides an end effector including an electrode having a peripheral wall and a silicone seal on the clamp arm. Figure 39 to Figure 41 An electrode is shown including a peripheral wall. Figure 39 A clamp arm 2640 is shown according to at least one aspect of the present disclosure, including an electrode 2642 having a peripheral wall 2644 supported by a jaw 2646 and a clamp arm pad 2647. Figure 40 is a cross-sectional view of the jaw 2640 taken along section 173-173 in Figure 39 Due to a desire to prevent or minimize tissue penetration and accumulation / adhesion between the electrode 2642 and the jaw 2644, in one aspect, the size and configuration of the peripheral wall 2644 around the electrode 2642 is set to prevent tissue from traveling under the electrode 2642 in a space 2643 defined between the electrode 2642, the jaw 2646, and the clamp arm pad 2647 and accumulating. The electrode 2642 is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflecting under load, where the electrode 2642 is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0278] Figure 41 is an electrode including Figure 39 to Figure 40 Alternative or additional features of the electrode shown. In Figure 41 In the aspect shown, a sealant 2648 such as silicone or other fluid polymer can be provided in a space 2645 under the electrode 2642 and over the jaw 2646 to prevent tissue from traveling under the electrode 2642 and accumulating, according to at least one aspect of the present disclosure.

[0279] In one aspect, the present disclosure provides an end effector including a skirt for a deflectable / cantilevered electrode. After heating tissue in an RF-based energy surgical device, it is common for tissue to adhere to the RF electrode and for fluid to accumulate between the electrode and the jaw. Thus, it is desirable to mitigate tissue / fluid accumulation between the electrode and the clamp arm or prevent tissue extrusion. In one aspect, the present disclosure provides an end effector including a skirt for a deflectable / cantilevered electrode. Figure 42 to Figure 44The illustrated electrode is used to prevent or minimize tissue and fluid buildup between the electrode and the clamp arm, thereby limiting the deflection function of the electrode or preventing the electrode from returning to a neutral position when not clamped. The electrode is fixed to the clamp at the proximal end and is free to deflect at the distal end. Thus, throughout this disclosure, the electrode can be referred to as a cantilevered beam electrode or deflectable electrode. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflecting under load, where the electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0280] The overlapping configuration of the skirt adds incremental stiffness to the deflectable electrode. When deflected, the skirt moves outward to clean / evacuate tissue around the clamp arm.

[0281] Figure 42 A clamp arm 2650 according to at least one aspect of the present disclosure is illustrated, including a clamp 2652, an electrode 2654, a clamp arm pad 2656 with a plurality of teeth 2657, Figure 43 ) and a deflectable flange 2658 along the lateral sides of the electrode 2654. Figure 43 to Figure 44 is taken along section 176-176 Figure 42 A cross-sectional view of the clamp arm 2650 is illustrated. Figure 43 The electrode 2654 and skirt 2658 are illustrated in an undeflected state, and Figure 44 The electrode 2654 and skirt 2658 are illustrated in a deflected state, where the skirt 2658 moves laterally in the direction shown by arrow 2659.

[0282] Referring now to Figure 42 to Figure 43 The clamp arm 2650 is configured for use with an end effector including an ultrasonic blade for a combined ultrasonic / bipolar RF energy device. For example, the proximal end 2660 of the electrode 2654 is attached to the clamp 2652 by any suitable fastener 2653 or fastening technique, such as welding, laser welding, brazing, soldering, pressing, and other fastening techniques. The distal end 2662 of the electrode 2654 is free to move as in a cantilevered beam. As previously mentioned, the clamp arm pad 2656 is made of a flexible material such as Teflon (PTFE), but can be replaced with similar polymers. The electrode 2654 is fixed to the clamp 2652 at the proximal end and is free to deflect at the distal end. Thus, throughout this disclosure, the electrode 2654 can be referred to as a cantilevered beam electrode or deflectable electrode.

[0283] The deflectable flange includes an overmolded elastomeric skirt 2658 disposed between the electrode 2654 and the clamp 2652 and overlapping the electrode 2654 on the lower perimeter of the electrode 2654. The overmolded skirt 2658 prevents tissue and fluid from accumulating or being extruded between the electrode and the clamp when the electrode 2654 and clamp 2652 are in a deflected state. Additionally, the overlapping configuration of the overmolded skirt 2658 to the clamp 2652 can stiffen the electrode 2654 if so desired for a particular implementation. As the electrode 2654 is deflected toward the clamp 2652, the overmolded skirt 2658 is displaced outward to clean and expel tissue from the periphery of the clamp arm 2658 electrode 2654 or clamp 2652.

[0284] In one aspect, the present disclosure provides an end effector comprising an electrode curtain. After heating tissue in RF-based energy surgical devices, it is common for tissue adhesion to occur between the clamp and the RF electrode. Thus, as previously mentioned, it is desirable to reduce tissue accumulation between the electrode and the clamp arm in a combined ultrasonic / bipolar RF energy surgical device. Thus, as disclosed herein Figure 45 to Figure 47 As shown, various clamp arms are configured to reduce tissue accumulation and sticking points. In one aspect, the clamp arm includes an electrode that extends down the side of the clamp arm similar to a curtain to reduce the gap in which tissue can enter and accumulate during RF sealing. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load, wherein the electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0285] Figure 45 A clamp arm 2670 is shown in accordance with at least one aspect of the present disclosure, including a clamp 2672, an electrode 2674, and a side wall 2676 extending down from the electrode 2674 past a side wall 2678 of the clamp 2672, and a clamp arm pad 2677 having a plurality of teeth 2679 Figure 46 ) from the electrode 2674. Figure 46 is a cross-sectional view of the clamp arm 2670 taken along section 46-46 Figure 45 shown in FIG. 27. With reference to Figure 45 to Figure 46The clamping arm 2670 is configured for use with an end effector comprising an ultrasonic blade for a combination ultrasonic / bipolar RF energy surgical device. The sidewall 2676 of the electrode 2674 covers the lateral sides of the clamp jaw 2672 and extends around the distal end 2684 of the clamp jaw 2672 to close the gap and prevent tissue from accumulating in the space 2680 defined between the electrode 2674 and the clamp jaw 2672. The arrow 2682 indicates the deflection path of the electrode 2674. As previously mentioned, the clamping arm pad 2686 is made of a flexible material such as PTFE or similar polymer material. The electrode 2674 is attached to the proximal end 2688 of the clamp jaw 2672 by any suitable fastener 2673 or fastening technique such as welding, laser welding, brazing, soldering, pressing, and other fastening techniques, for example. The electrode 2674 is fixed to the clamp jaw 2672 at the proximal end and is free to deflect at the distal end. Accordingly, throughout this disclosure, the electrode 2674 can be referred to as a cantilevered beam electrode or a deflectable electrode.

[0286] Figure 47 A top perspective view of an electrode 2710 is shown in accordance with at least one aspect of the present disclosure. The electrode 2710 includes a lip 2712 extending downward from a top surface 2714 of the electrode 2710. Figure 45 to Figure 46 An alternative clamping arm 2690 of the clamping arm 2670 is shown. The clamping arm 2690 includes a clamp jaw 2692, an electrode 2694, and a clamping arm pad 2697, wherein the electrode has a sidewall 2696 that extends downward from the electrode 2694 past a sidewall 2698 of the clamp jaw 2692. The sidewall 2698 prevents tissue from accumulating in a space 2691 defined between the electrode 2694 and the clamp jaw 2692. The clamping arm 2690 also includes a deflection stop surface 2700 distal to the tissue interface. The electrode 2694 is fixed to the clamp jaw 2692 at the proximal end and is free to deflect at the distal end. Accordingly, throughout this disclosure, the electrode 2694 can be referred to as a cantilevered beam electrode or a deflectable electrode.

[0287] In one aspect, the present disclosure provides an end effector comprising a deflectable / cantilevered electrode that includes a shielding lip to prevent tissue accumulation from occurring in the end effector or components thereof. After heating tissue in an RF-based energy surgical device, it is common for tissue adhesion to occur between the clamp jaw and the RF electrode. Accordingly, as previously mentioned, it is desirable to prevent or minimize tissue accumulation between the electrode and the clamp jaw. Figure 48 A top perspective view of an electrode 2710 is shown in accordance with at least one aspect of the present disclosure. The electrode 2710 includes a lip 2712 extending downward from a top surface 2714 of the electrode 2710. Figure 49 A bottom perspective view of the electrode 2710 is shown in accordance with at least one aspect of the present disclosure. The electrode 2710 includes a lip 2712 extending downward. Figure 48 A bottom perspective view of the electrode 2710 is shown in accordance with at least one aspect of the present disclosure. The electrode 2710 includes a lip 2712 extending downward. Figures 50-51 A top perspective view of the electrode 2710 is shown in accordance with at least one aspect of the present disclosure. The electrode 2710 includes a lip 2712 extending downward from a top surface 2714 of the electrode 2710. Figures 48-49 A top perspective view of the electrode 2710 is shown in accordance with at least one aspect of the present disclosure. The electrode 2710 includes a lip 2712 extending downward from a top surface 2714 of the electrode 2710.

[0288] Reference is now made to Figures 48-51 The electrode 2710 defines an aperture 2716 to accept the element of the clamp arm pad therethrough. The electrode 2710 is configured for use with an end effector comprising an ultrasonic blade for an ultrasonic / bipolar RF combined energy device. The electrode 2710 is fixed to the jaws at the proximal end and is free to deflect at the distal end. Thus, throughout this disclosure, the electrode 2710 can be referred to as a cantilevered beam electrode or deflectable electrode.

[0289] Thus, Figures 48-51 The shield lip 2712 for the electrode 2710 serves to prevent tissue build-up in the space defined between the electrode 2710 and the jaws. The lip 2712 encircles the clamp arm and electrode 2710 to prevent tissue from entering the space between the electrode 2710 and the jaws. An insulating coating can be added to the lip 2712 to prevent any electrode activity from the lip 2712. The electrode 2710 is fixed to the jaws at the proximal end and is free to deflect at the distal end. Thus, throughout this disclosure, the electrode can be referred to as a cantilevered beam electrode or deflectable electrode. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflecting under load, where the electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0290] In one aspect, the present disclosure provides an end effector comprising a deflectable / cantilevered electrode with a compression block and a single clamp arm pad unit. In one aspect, the deflectable / cantilevered electrode with a compression block and a single clamp arm pad unit is configured to reduce the trade-off decisions between ultrasonic and bipolar RF devices with precise dissection and multiple reliable sealing functions. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflecting under load, where the electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0291] In one aspect, the end effector utilizes a single clamp arm pad with a collar feature to prevent electrode delamination when the jaws are opened and a pre-compressed block to prevent tissue debris from entering the side gap between the electrode and the jaws to reduce the risk of jamming.

[0292] In one aspect, the end effector architecture comprises an end effector clamp arm side with multiple single clamp arm pad units. Each of the single clamp arm pad units has a collar feature to constrain electrode delamination when the jaws are opened, increase pad volume relative to the ultrasonic blade tip, and has a foot / end feature to align and be constrained by a slot feature on the clamp arm.

[0293] On the other hand, the end effector includes an electrode with a groove feature in a particular direction to allow for electrode assembly and help hold the clamping arm pad in place.

[0294] On another front, the end effector includes a compression block located between the electrode and the clamp to prevent tissue fragments from entering the side gaps and reduce the risk of getting stuck, help keep the components together, and ensure that there is no gap between the pad collar and the electrode before clamping the tissue.

[0295] Figure 52 An end effector 2720 comprising a clamping arm 2722 and an ultrasonic scalpel 2724 is shown according to at least one aspect of this disclosure. See also... Figures 53-54 The clamping arm 2722 includes a clamp 2726, an electrode 2728, a one-piece elastic / hyperelastic block 2734, a small wear-resistant gap pad 2736, and a large wear-resistant gap pad 2738, wherein the electrode is sized and configured to receive multiple orifices 2730 of multiple individual tissue pad units 2732. The one-piece elastic / hyperelastic block 2734 is made of an elastic or hyperelastic material to provide spring-like properties, such as, for example, porous, rubber, or sponge. The electrode 2728 serves as one pole of a bipolar RF circuit, and the ultrasonic scalpel 2724 serves as the opposite pole of the bipolar RF circuit. The electrode 2728 is fixed to the clamp 2726 at its proximal end and is freely deflectable at its distal end. Therefore, throughout this disclosure, the electrode 2728 may be referred to as a cantilever beam electrode or a deflectable electrode.

[0296] Figure 55 Various views of a single tissue pad unit 2732 according to at least one aspect of the present disclosure are shown. The tissue pad unit 2732 includes a pad collar 2742, a pad neck 2746, a pad foot 2748, and a pad end 2750. When tissue is clamped, the tissue pushes the electrode 2728 to a deflected state, while the electrode 2728 pushes a slightly compressed elastic block 2734 to a higher degree of compression. When the tissue is fully cut, the higher degree of compression block 2734 is pushed rearward against the electrode 2728 against the tissue pad collar 2740, and the block 2734 remains slightly compressed to maintain zero gap between the tissue pad unit 2732 and the electrode 2728. When the clamp 2726 is opened, the tissue pad collar 2740 prevents delamination of the electrode 2728.

[0297] Figure 56 An electrode 2728 according to at least one aspect of the present disclosure is shown. The electrode 2728 defines a plurality of orifices 2730. The plurality of orifices 2730 serve as grooves on the electrode 2728, having a... Figure 55 The pad portion 2748 shown has a similar shape. Electrode 2728 also defines two grooves 2752 for receiving small wear-resistant gap pads 2736 and another groove 2754 for receiving large wear-resistant gap pads 2738.

[0298] Figure 57 A cross-sectional view of the clamp arm 2722 is shown, showing the elastic / super-elastic block 2734, in accordance with at least one aspect of the present disclosure. In one aspect, the elastic / super-elastic block 2734 acts as a pre-compression block 2734 to push the electrode 2728 against the tissue pad collar 2740 and the clamp arm 2722 at the contact area against the pad foot 2748 (as shown by arrow 2756) to hold the components together and ensure no gap between the pad collar 2742 and the electrode 2728 prior to clamping tissue.

[0299] Figure 58 is a perspective view of the elastic / super-elastic block 2734. Figure 59 and Figure 61 is a perspective view of a sub-assembly 2760 including the clamp jaw 2726, the electrode 2728, and the single tissue pad unit 2732, in accordance with at least one aspect of the present disclosure. This view shows the side gap 2758 formed between the electrode 2728 and the clamp jaw 2726. Figure 60 is a perspective view of the clamp arm 2722 assembly including the elastic / super-elastic block 2734 of Figure 58 , assembled to the sub-assembly 2760, in accordance with at least one aspect of the present disclosure. Now referring to Figures 58-61 , the pre-compression block 2734 prevents tissue debris from entering the side gap 2758 between the electrode 2728 and the clamp jaw 2726, thereby reducing the risk of getting stuck.

[0300] Figure 62 A first assembly step is shown, in accordance with at least one aspect of the present disclosure. In this step, the single tissue pad unit 2732 is inserted into the electrode 2728. The tissue pad foot 2748 is aligned with the electrode pad slot 2730 and the tissue pad unit 2732 is inserted into the electrode pad slot 2730 until the tissue pad collar 2742 is seated against the electrode 2728.

[0301] Figures 63-65 A second assembly step is shown, in accordance with at least one aspect of the present disclosure. In this step, the single tissue pad unit 2732 is locked into the electrode 2728. The tissue pad unit 2732 is rotated counterclockwise 35° (see also Figure 56 ), in this “locked” position, the pad foot 2748 and pad collar 2742 features are against preventing the tissue pad unit 2732 from falling out of the electrode 2728. Also, in this position, the pad tip 2750 is approximately aligned for assembly into the clamp arm 2722. This results in a first sub-assembly 2762.

[0302] Figure 66A third assembly step in accordance with at least one aspect of the present disclosure is shown. In this step, the single piece elastic / super-elastic block 2734 is bonded to the clamp jaw 2726. This results in a second sub-assembly 2764.

[0303] Figures 67-72 A fourth assembly step in accordance with at least one aspect of the present disclosure is shown. In this step, the large wear gap pad 2738 is inserted into the slot 2754 defined by the electrode 2728. Figures 63-65 The first sub-assembly 2762 resulting from the second assembly step described is assembled with the second sub-assembly 2764 resulting from the third assembly described in the step as Figure 66 The first sub-assembly 2762 resulting from the second assembly step described is assembled with the second sub-assembly 2764 resulting from the third assembly described in the step as

[0304] Figures 73-74 A fifth assembly step in accordance with at least one aspect of the present disclosure is shown. In this step, two small wear gap pads 2736 are press fit into the slot 2752 defined by the electrode 2728 and the large wear gap pad 2738 is slipped into the slot 2754 defined by the electrode 2728.

[0305] In one aspect, the present disclosure provides an end effector that includes a filled gap between an electrode and a clamp arm. After heating tissue in RF-based energy surgical devices, it is a common occurrence that tissue adhesion occurs between the clamp jaw and the RF electrode. Thus, as previously described, it is desirable to prevent or minimize adhesion between the clamp jaw and the electrode in the clamp arm. Thus, Figure 75A clamp arm 2780 is shown that includes a filler material 2782 between the electrode 2784 and the clamp 2786 in accordance with at least one aspect of the present disclosure. The filler material 2782 can be a woven nylon or a 3D printed structure. The filler material 2782 prevents tissue from entering the space 2788 between the electrode 2784 and the clamp 2786. The 3D printed structure can be printed in a specific shape in order to maximize compression. The electrode 2784 is fixed to the clamp 2786 at a proximal end and is free to deflect at a distal end. Thus, throughout the present disclosure, the electrode 2784 can be referred to as a cantilevered beam electrode or a deflectable electrode. The electrode 2784 is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflecting under a load, where the electrode 2784 is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0306] In one aspect, the present disclosure provides an end effector that includes a deflectable / cantilevered electrode. It is desirable to improve the ease of manufacture of the electrode, reduce tissue accumulation between the electrode and the clamp. It is also desirable to prevent or minimize tissue adhesion to the electrode. Figures 76-78 Various devices are shown that address these desires for improvement in accordance with at least one aspect of the present disclosure. The electrode is fixed to the clamp at a proximal end and is free to deflect at a distal end. Thus, throughout the present disclosure, the electrode can be referred to as a cantilevered beam electrode or a deflectable electrode. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflecting under a 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.

[0307] In Figure 76 In the illustrated aspect, the clamp arm 2790 is easier to manufacture by eliminating a separate clamp arm electrode and establishing the surface 2792 of the clamp arm and eliminating a separate electrode blade. The clamp arm now becomes the electrode. A Vespel clamp arm pad 2794 is also overmolded onto the clamp 2796.

[0308] In Figure 77 In the illustrated aspect, the clamp arm 2800 prevents tissue accumulation between the electrode 2802 and the clamp 2804 by adding a skirt 2806 to the periphery of the electrode 2802 or alternatively to the periphery of the clamp 2804. This still allows the electrode 2802 to deflect but still prevents tissue accumulation. The electrode 2802 is fixed to the clamp 2804 at a proximal end and is free to deflect at a distal end. Thus, throughout the present disclosure, the electrode 2802 can be referred to as a cantilevered beam electrode or a deflectable electrode.

[0309] In Figure 78In the illustrated aspect, a cross-sectional view of an end effector 2810 including an ultrasonic blade 2812 and a clamp arm 2814 configured to improve distal tissue gripping is shown. The clamp arm 2814 defines a curvature 2816 at the distal end of the polyimide gap arm pad and / or the distal end of the teeth of the clamp arm pad (PTFE).

[0310] In one aspect, the present disclosure provides an end effector configured to minimize tissue sticking via electrode geometry and clamp arm bumper / horn element. After heating tissue in RF-based energy surgical devices, it is common for tissue to stick to the RF electrode. Thus, as previously mentioned, it is desirable to minimize or prevent tissue sticking to the RF electrode. This can be achieved by new electrode geometry and adding a clamp arm bumper / horn to the clamp to minimize electrode delamination. Figure 79 A clamp arm 2820 according to at least one aspect of the present disclosure is shown, which includes a clamp 2822, an electrode 2824, a clamp arm pad 2826 having a plurality of teeth 2836, a drape 2828 on either side of the electrode 2824 to minimize the point of extrusion of tissue, and a horn / bumper 2830 to minimize delamination of the electrode 2824 by contacting tissue first during blunt dissection. The clamp arm 2820 also includes a hard gap set pad 2832 at the proximal end 2834 of the clamp arm 2820. The clamp arm pad 2826 is made of a flexible polymer such as Teflon (PTFE) and the hard gap set pad 2832 is made of a hard polyimide material. The electrode 2824 is fixed to the clamp 2822 at the proximal end and is free to deflect at the distal end. Thus, throughout the present disclosure, the electrode 2824 can be referred to as a cantilevered beam electrode or a deflectable electrode. The electrode 2824 is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflecting under load, where the electrode 2824 is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0311] Figures 80-81 An alternative clamp arm 2840 according to at least one aspect of the present disclosure is shown, which includes a clamp 2842, an electrode 2844, a clamp arm pad 2846 having a plurality of teeth 2854, and a drape 2848 on either side of the clamp arm pad 2846. Figure 80 An assembled view of the clamp arm 2840 is shown, Figure 80 is an exploded view of the clamp arm 2840, and Figure 81is a cross-sectional view of the clamp arm 2840 taken along section 81-81. The curtain 2848 prevents tissue extrusion and improves manufacturability of the clamp arm 2840. The proximal end 2850 of the clamp arm 2840 includes a hard gap setting pad 2852. The electrode 2844 includes a plurality of apertures 2854 to receive a plurality of clamp arm pad 2846 teeth. The clamp arm pad 2846 is made of a flexible polymer such as Teflon (PTFE) and the hard gap setting pad 2852 is made of a hard polyimide material. The electrode 2844 is fixed to the clamp jaw 2842 at the proximal end and is free to deflect at the distal end. Thus, throughout this disclosure, the electrode 2844 can be referred to as a cantilevered beam electrode or a deflectable electrode.

[0312] In one aspect, the present disclosure provides an end effector including a deflectable electrode having anti-tissue adhesion features. After heating tissue in an RF-based energy surgical device, it is common for tissue to adhere to the RF electrode. The tissue typically separates and flows into the space around the electrode and then re-solidifies to form an anchor point for the larger tissue mass. It is desirable to prevent or separate the anchored tissue to ensure no tissue adhesion. Figures 82-85 A clamp arm 2860 is shown that includes a clamp jaw 2862, a cantilevered electrode 2864, a clamp arm pad 2866 having teeth 2868 received through apertures 2870 defined by the cantilevered electrode 2864, and hard gap setting pads 2872, 2874, in accordance with at least one aspect of the present disclosure. The electrode 2864 is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflecting under load, where the electrode 2864 is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0313] Figure 82 and Figure 84 are a side view and a bottom perspective view, respectively, of a clamp arm pad 2860 in accordance with at least one aspect of the present disclosure. Both views show the cantilevered electrode 2864 in an undeflected state. Figure 83 and Figure 85 are a side view and a bottom perspective view, respectively, of a clamp arm pad 2860 in accordance with at least one aspect of the present disclosure, where the cantilevered electrode 2864 is in a deflected state to pull tissue out of the teeth 2868 of the clamp arm pad 2866.

[0314] Referring now to Figures 82-84 In one method, the cantilevered electrode 2864 is moved past the end of the pad teeth 2868 to pull tissue out of the anchor point before the tissue cools. The cantilevered electrode 2864 can move independently of the clamp jaw 2862 and the clamp arm pad 2866 with a spring force. The apertures 2870 in the cantilevered electrode 2864 for the clamp arm pad 2866 can be moved away from the clamp arm pad 2866 to ensure that there is no anchor point after sealing.

[0315] In various aspects, the present disclosure provides combination ultrasonic / bipolar RF energy surgical devices and systems. Various forms involve a user interface for a surgical instrument having an ultrasonic and / or electrosurgical (RF) end effector configured for performing tissue treatment, dissection, cutting, and / or coagulation during a surgical procedure. In one form, a user interface is provided for a combination ultrasonic and electrosurgical instrument that can be configured for open surgical procedures, but also applies to other types of surgical procedures, such as minimally invasive laparoscopic, visual or thoracoscopic procedures, e.g., non-invasive endoscopic procedures in hand-held or robotically assisted procedures. Versatility is achieved by selectively applying multiple energy modalities simultaneously, independently, sequentially, or a combination thereof. For example, versatility can be achieved by selectively using ultrasonic and electrosurgical energy (e.g., monopolar or bipolar RF energy) simultaneously, independently, sequentially, or a combination thereof.

[0316] In one aspect, the present disclosure provides a user interface for a device that includes an ultrasonic blade and a clamp arm having a deflectable RF electrode, such that the ultrasonic blade and deflectable RF electrode cooperate to perform sealing, cutting, and clamping of tissue by cooperation of a clamping mechanism of the device including the RF electrode with the associated ultrasonic blade. The clamping mechanism includes a pivoting clamp arm that cooperates with the ultrasonic blade to grasp tissue therebetween. The clamp arm preferably has a clamping tissue pad (also referred to as a "clamp arm pad") having a plurality of axially spaced-apart clamping teeth, segments, elements, or individual cells that cooperate with the ultrasonic blade of the end effector to achieve desired sealing and cutting effects on tissue while facilitating grasping and clamping of tissue during a surgical procedure.

[0317] In one aspect, the end effectors described herein include an electrode. In other aspects, the end effectors described herein include alternative forms of electrodes to provide flexible coupling of RF energy to tissue, accommodate pad wear / thinning, minimize generation of excess heat (low coefficient of friction, pressure), minimize generation of sparks, minimize interruptions due to electrical shorts, or other combinations thereof. The electrode is fixed to the clamp at a proximal end and is free to deflect at a distal end. Thus, throughout the present disclosure, the electrode can be referred to as a cantilevered beam electrode or deflectable electrode.

[0318] In other aspects, the end effectors described herein include a clamp arm mechanism configured to be able to exert high pressure between the pad and the ultrasonic blade to grasp and seal tissue, maximize the likelihood of the clamp arm electrode contacting tissue in restricted or difficult scenarios, such as, for example, thin tissue, tissue under lateral tension, tissue tenting / vertical tension, especially when tented tissue is distanced from the clamp arm.

[0319] In other aspects, the end effectors described herein are configured to enable a balance of surface area / current density match between electrodes, balance and minimize heat conduction from tissue interfaces, such as for example, affecting lesion formation and symmetry, cycle time, residual thermal energy. In other aspects, the end effectors described herein are configured to enable minimize adhesion, tissue sticking (minimize anchor points) and can include small polyimide pads.

[0320] 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 energy, a second button switch for selecting an energy mode for the activation button switch. The second button switch is connected to a circuit that uses at least one input parameter to define the energy mode. The input parameter can be modified remotely through a connection to a generator or through a software update.

[0321] In one aspect, at least one of the energy modes is a simultaneous mix of RF energy and ultrasound energy, and the input parameter represents a duty cycle of the RF energy and ultrasound energy.

[0322] In one aspect, the second button switch is configurable to select from a predefined list of modes, and the number of modes in the list is defined by a second input parameter defined by a user.

[0323] In one aspect, the input parameter is a duty cycle, voltage, frequency, pulse width, or current.

[0324] In one aspect, the device further includes a visual indicator of the selected energy mode within the device in the surgical field.

[0325] In one aspect, the second button switch is a separate control from the end effector closure trigger.

[0326] In one aspect, the second button switch is configured to actuate a second stage of the closure trigger. The first stage of the closure trigger in the closing direction is to actuate the end effector.

[0327] In one aspect, at least one of the energy modes is selected from ultrasound, RF bipolar, RF monopolar, microwave, or IRE.

[0328] 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 at a predefined duty cycle or pulse algorithm.

[0329] In one aspect, at least one of the energy modes is selected from two or more of the following types of energy applied sequentially: ultrasound, RF bipolar, RF monopolar, microwave, or IRE.

[0330] In one aspect, at least one of the energy modes is a simultaneous mix of two or more of the following types of energy: ultrasound, RF bipolar, RF monopolar, microwave, and IRE.

[0331] In one aspect, at least one of the energy modes is a simultaneous mix of two or more of the following types of energy: ultrasound, RF bipolar, RF monopolar, microwave, and IRE, followed by one or more of the above energies.

[0332] In one aspect, at least one of the energy modes is one of the following types of energy: ultrasound, RF bipolar, RF monopolar, microwave, and IRE, followed by a simultaneous mix of two or more of the above energies.

[0333] In one aspect, at least one of the energy modes is a procedure or tissue specific predefined algorithm.

[0334] In one aspect, at least one of the energy modes is compiled from learned surgical behavior or activity.

[0335] In one aspect, the input parameters are at least one of the following: energy type, duty cycle, voltage, frequency, pulse width, current, impedance limit, activation time, or energy mix.

[0336] In one aspect, the second button switch is configurable to be able to select from a predefined list of modes, and the number of modes in the list is predefined or defined by a second input parameter defined by the user.

[0337] In one aspect, the above energy modes are made available to the user through a software update to the generator.

[0338] In one aspect, the above energy modes are made available to the user through a software update to the device.

[0339] In one aspect, the user’s preferred selection is made available to multiple generators through a network, cloud, or human transfer.

[0340] In one aspect, the device further comprises a visual indicator of the selected energy mode within the device’s portion in the surgical field.

[0341] As used herein, a pushbutton switch can be a hand, mechanical or electrically operated electromechanical device with one or more sets of electrical contacts connected to an external circuit. Each set of electrical contacts can be in one of two states: "closed" meaning the contacts are touching and electricity can flow between them, or "open" meaning the contacts are separated and the switch is non-conductive. The mechanism that actuates to switch between these two states (open or closed) can be of the "toggle" (flip the switch to a continuous "on" or "off) or "momentary" (push for "on" and release for "off) type.

[0342] In one aspect, the present disclosure provides a combination ultrasonic / bipolar RF energy surgical device that includes mode selection and visual feedback on the device. As surgical devices evolve and become more functional, the number of specialized modes in which they can be operated increases. Adding additional pushbutton switches to the device to accommodate these new additional modes would complicate the user interface and make the device more difficult to use. Accordingly, the present disclosure provides techniques for designating different modes to a single physical pushbutton switch, which can have more mode selections and not increase the complexity of the housing design (e.g., not add more and more pushbutton switches). In one aspect, the housing is in the form of a handle or pistol grip.

[0343] As more specialized modes become available, there is a need to provide the surgeon using the surgical device with multiple modes without creating a complicated user interface. Surgeons want to be able to control mode selection from the sterile field, rather than relying on a circulating nurse at the generator. Surgeons want real-time feedback so they have confidence in knowing which mode to select.

[0344] Figure 86 A surgical device 100 is shown in accordance with at least one aspect of the present disclosure that includes a mode selection pushbutton switch 130 on the device 100. The surgical device 100 includes a housing 102 that defines a handle 104 in the form of a pistol grip. The housing 102 includes a trigger 106 that is received into an interior space defined by the handle 104 when squeezed. The trigger 106 is used to operate the clamp arm 111 portion of the 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 by a shaft 108 that can be rotated by a knob 122.

[0345] The end effector 110 includes a clamp arm 111 and an ultrasonic blade 116. The clamp arm 111 includes 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-stick, lubricious material such as PTFE or similar tetrafluoroethylene synthetic fluoropolymer. PTFE is a hydrophobic, non-wetting, high-density, and high-temperature-resistant, multi-purpose material and has non-stick properties. The clamp arm pad 120 is non-conductive. In contrast, the electrode 118 is made of a conductive material to deliver electrical energy such as monopolar RF, bipolar RF, microwave, or irreversible electroporation (IRE). The electrode 118 can include a gap-set pad made of a polyimide material, and in one aspect, is made of a durable, high-performance polyimide-based plastic known by the trade name VESPEL and manufactured by DuPont or other suitable polyimide, polyimide polymer alloy, or PET (polyethylene terephthalate), PEEK (polyether ether ketone), PEKK (polyether ketone ketone) polymer alloy. Unless otherwise noted below, the clamp arm pad and gap pad described below are made of the materials described in this paragraph.

[0346] 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 certain implementations, 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 to actuate the ultrasonic blade 116. The electrical circuit can be housed in the housing 102 or can reside in the generator 133. The surgical device 100 is coupled to the generator 133 via a cable 131. The cable 131 conducts signals for the electrosurgical functions and the ultrasonic transducer.

[0347] In various aspects, the surgical device 100 is configured to deliver at least two energy types (e.g., ultrasonic, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue in 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 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 an electrical circuit that uses at least one input parameter to define the energy mode. The input parameter can be modified remotely through a connection to the generator or through a software update. The energy mode is displayed on a user interface 128.

[0348] In one aspect, the surgical instrument 100 provides mode switching through an on-device forward selector “mode” button switch 130. The user can press the mode button switch 130 to switch between different modes, and a colored light on the user interface 128 indicates the selected mode.

[0349] According to various aspects of the present disclosure, different modes of operation can be assigned to the surgical device by pressing the "mode" button switch 130, where each press or push and hold of the mode button switch 130 toggles the surgical device 100 between the available modes displayed on the user interface 128. Once a mode is selected, the generator 133 will provide the appropriate generator tone and the surgical device 100 will have an illuminated indicator on the user interface 128 to indicate which mode is selected.

[0350] In Figure 86 In the example shown, the "mode" selection button switch 130 is placed symmetrically on both sides of the housing 102. This allows right and left handed surgeons to select / toggle modes without using a second hand. In this regard, the "mode" selection button switch 130 can toggle in many different directions, allowing the surgeon to select from a list of options and navigate more complex selections remotely from the sterile field without requiring a circulator to make adjustments at the generator 133. In addition to the tone of the generator 133, the illuminated indicator on the user interface 128 of the surgical device 100 gives the surgeon feedback as to which mode is selected.

[0351] Figures 87A-87C Three options for selecting various modes of operation of the surgical device 100 are shown, according to at least one aspect of the present disclosure. In addition to the colored light user interface 128 on the housing 102 of the surgical device 100, feedback for mode selection is audible and / or visible through the interface of the generator 133, where the generator 133 announces the selected mode in voice and / or displays a description of the selected mode on the screen of the generator 133.

[0352] Figure 87A A first mode selection option 132A is shown, where the button switch 130 can be pressed forward 136 or backward 134 to cycle the surgical instrument 100 through various modes.

[0353] Figure 87B A second mode selection option 132B is shown, where the button switch 130 is pressed up 140 or down 138 to cycle the surgical instrument 100 through various modes.

[0354] Figure 87C A third mode selection option 132C is shown, where the button switch 130 is pressed forward 136, backward 134, up 149, or down 138 to cycle the surgical instrument 100 through various modes.

[0355] Figure 88A surgical device 150 is shown in accordance with at least one aspect of the present disclosure that includes a mode selection button switch 180 on the back of the device 150. The surgical device 150 includes a housing 152 that defines a pistol grip form of a handle 154. The housing 152 includes a trigger 156 that is received into an interior space defined by the handle 154 when squeezed. 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 by a shaft 158 that can be rotated by a knob 172.

[0356] The end effector 160 includes the clamp arm 161 and an ultrasonic blade 166. The clamp arm 161 includes the clamp jaw 162, an electrode 168, and a clamp arm pad 170. In one aspect, the clamp arm pad 170 is made of a non-stick, lubricious material such as PTFE or similar tetrafluoroethylene synthetic fluoropolymer. PTFE is a hydrophobic, non-wetting, high-density, and high-temperature-resistant, multi-purpose material and has non-stick properties. The clamp arm pad 170 is non-conductive. In contrast, the electrode 168 is made of a conductive material to deliver electrical energy such as monopolar RF, bipolar RF, microwave, or irreversible electroporation (IRE). The electrode 168 can include a gap-set pad made of a polyimide material, and in one aspect, a durable, high-performance polyimide-based plastic known by the trade name VESPEL and manufactured by DuPont or other suitable polyimide, polyimide polymer alloy, or PET (polyethylene terephthalate), PEEK (polyether ether ketone), PEKK (polyether ketone ketone) polymer alloy. Unless otherwise noted below, the clamp arm pads and gap pads described below are made of the materials described in this paragraph.

[0357] The electrode 168 and the ultrasonic blade 166 are coupled to a generator 133. The generator 133 is configured to be able to drive RF, microwave, or IRE energy to the electrode 168. The generator 133 is also configured to be able to drive an ultrasonic transducer acoustically coupled to the ultrasonic blade 166. In certain implementations, 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 to actuate the ultrasonic blade 166. The electrical circuit can be housed in the housing 152 or can reside in the generator 133. The surgical device 150 is coupled to the generator 133 via a cable 181. The cable 181 conducts signals for the electrosurgical functions and the ultrasonic transducer.

[0358] In various aspects, the surgical device 100 is configured to be able to deliver at least two energy types (e.g., ultrasonic, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue located in 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 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 uses at least one input parameter to define the energy mode. The input parameter can be modified remotely through a connection to the generator or through a software update. The energy mode is displayed on the user interface 128.

[0359] In one aspect, the surgical instrument 150 provides mode switching through an on-device forward selector "mode" button switch 180. The user can press the mode button switch 180 to switch between different modes, and a colored light on the user interface 178 indicates the selected mode.

[0360] According to various aspects of the present disclosure, different operating modes can be assigned to the surgical device by pressing the "mode" button switch 180, where each press or push and hold of the mode button switch 180 switches the surgical device 150 between available modes displayed on the user interface 178. Once a certain mode is selected, the generator 133 will provide the appropriate generator tone, and the surgical device 150 will have a lit indicator on the user interface 178 to indicate which mode is selected.

[0361] In Figure 88 In the example shown, the "mode" selection button switch 180 is placed on the back of the housing 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 a second hand is required to change modes. This is intended to prevent accidental activation. To change modes, the surgeon must intentionally press the mode button switch 180 with their second hand. In addition to the tone of the generator, a lit indicator on the user interface 178 of the surgical device 150 gives the surgeon feedback as to which mode is selected.

[0362] Figure 89A A first mode selection option is shown, where a colored light on the user interface 178 indicates the selected mode as the mode button switch 180 is pressed to switch between various modes.

[0363] Figure 89B A second mode selection option is shown, where a screen 182 indicates the selected mode (e.g., LCD, e-ink) as the mode button switch 180 is pressed to switch between various modes.

[0364] Figure 89CA third mode selection option is shown, where as the mode button switch 180 is depressed to switch between various modes, the labeled light 184 indicates the selected mode.

[0365] Figure 89D A fourth mode selection option is shown, where as the labeled button switch 186 is depressed to select a mode, it is illuminated to indicate the selected mode when the labeled button switch 180 is selected.

[0366] In one aspect, the present disclosure provides a combination ultrasonic / bipolar RF energy surgical device that is activated by a trigger closure. As more functionality is 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. Further, when using an advanced energy surgical device to control bleeding, the difficulty of using the user interface or the ability that is difficult to obtain will spend critical time and attention during a surgical procedure.

[0367] According to the present disclosure, monopolar RF energy or advanced bipolar RF energy is activated by closing the trigger by squeezing the trigger through a first closure click to a second activation click and holding the closure until the power in the generator is stopped. The energy can also be reapplied immediately by the number of times needed to slightly release and re-squeeze the trigger.

[0368] Figure 90 A surgical device 190 including an activation mechanism of a trigger 196 according to at least one aspect of the present disclosure is shown. 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 into an interior space defined by the handle 194 when squeezed. The housing 192 is coupled to an end effector by a shaft 198 that can be rotated by a knob 202. The surgical device 190 is coupled to a generator 206 via a cable 204. The cable 204 conducts signals for electrosurgical functions and an ultrasonic transducer.

[0369] The trigger 196 is configured to be able to operate the clamp arm portion of the end effector and to trigger electrosurgical energy, thus eliminating the need for Figure 86 and Figure 88 the activation button switches 126, 176 shown. The trigger 196 closes to a first audible and tactile click to close the forceps for grasping tissue and further closes to a second audible and tactile click to activate electrosurgical energy such as monopolar or bipolar RF, microwave, or IRE energy. The entire sequence is accomplished by activating the front button switch for cutting using ultrasonic energy.

[0370] Procedure for operating surgical device 190: Squeeze trigger 196 to the first audible and tactile click; verify the target tissue in the forceps; activate RF energy by further squeezing trigger 196 to the second audible and tactile click until the end tone is heard; cut until the tissue is split by pressing ultrasound pre-switch 200.

[0371] Modified procedure for operating surgical instrument 190 to gain additional capabilities: RF energy is activated and maintained with trigger 196, while the front push-button switch 200 is activated to activate the ultrasound transducer, which results in the simultaneous application of electrosurgical and ultrasound energy modes being delivered to the tissue at the same time.

[0372] In an alternative implementation, the front push-button switch 200 for activating ultrasound energy can be switched to different speeds via a mode selector on the surgical device 190 or the power generator 206.

[0373] For example, the above text combined Figures 86-90 The surgical instruments 100, 150, and 190 described, and the associated algorithms (including...) Figures 1-85 The end effector can be implemented, for example, in a surgical hub system in combination with a generator and a modular energy system.

[0374] Figure 91 An alternative clamping arm, comprising a metal clamp, an electrode, a plurality of clamping arm pads, and a gap pad, is shown according to at least one aspect of the present disclosure. Figure 91 An alternative clamping arm 2900 is shown according to at least one aspect of the present disclosure, comprising a metal clamp 2904, an electrode 2906, a plurality of clamping arm pads 2920 extending through a hole in the electrode 2906, a gap pad 2930, and a gap pad 2910. The electrode 2906 is attached to the metal clamp 2906 at a welding position 2908. The electrode 2906 encloses the metal clamp 2904 and is deflectable. The gap pad 2910 has a top PI layer 2912 and a bottom elastomeric layer 2914 for pressure control directly attached to the metal clamp 2904. The clamping arm pad 2920 is directly attached to the metal clamp 2904 and is a composite pad having a high-pressure central region 2922 made of PTFE for heat reduction and an outer region 2924 made of PI for deflection of the electrode 2906.

[0375] In one respect, the combined ultrasound / bipolar RF energy surgical device is configured to operate within a surgical hub system. Figure 92 Surgical system 3102, according to at least one aspect of this disclosure, includes a surgical hub 3106 paired with a visualization system 3108, a robotic system 3110, and a smart instrument 3112. See now. Figure 92Hub 3106 is depicted as being integrated with visualization system 3108, robotic system 3110, and [other components]. Figures 86-91 The handheld intelligent surgical instrument 3112 is constructed in a similar manner to the surgical instruments 100, 150, and 190. 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 some aspects, such as... Figure 92 As shown, hub 3106 also includes smoke extraction module 3126 and / or suction / flushing module 3128.

[0376] During surgical procedures, the application of energy to tissue for sealing and / or cutting is often associated with fumigation, aspiration of excess fluid, and / or tissue flushing. Fluid lines, power lines, and / or data lines from different sources often become entangled during surgical procedures. Resolving this issue during surgical procedures can result in lost valuable time. Disconnecting lines may require disconnecting the lines from their respective modules, which may necessitate module reset. The hub modular housing 3136 provides a unified environment for managing power lines, data lines, and fluid lines, reducing the frequency of entanglement between such lines.

[0377] Various aspects of this disclosure provide a surgical hub for use in surgical procedures involving the application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combined generator module slidably received in a docking base within the hub housing. The docking base includes data contacts and power contacts. The combined generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component, housed in a single unit. In one aspect, the combined generator module further includes a smoke extraction component, at least one energy delivery cable for connecting the combined generator module to surgical instruments, at least one smoke extraction component configured to exhaust smoke, fluid, and / or particles generated by applying therapeutic energy to tissue, and a fluid line extending from a remote surgical site to the smoke extraction component.

[0378] In one aspect, the fluid line is a first fluid line, and the second fluid line extends from a remote surgical site to a suction and flushing module slidably received within a hub housing. In another aspect, the hub housing includes a fluid interface.

[0379] Certain surgical procedures can require the application of more than one energy type to tissue. One energy type can be more beneficial for cutting tissue, while a different energy type can be more beneficial for sealing tissue. For example, a bipolar generator can be used to seal tissue, while an ultrasonic generator can be used to cut the sealed tissue. Aspects of the present disclosure provide a solution in which the hub modular housing 136 is configured to be able to accommodate different generators and facilitate interactive communication between them. One of the advantages of the hub modular housing 136 is to enable quick removal and / or replacement of the various modules.

[0380] Aspects of the present disclosure provide a modular surgical housing for use in surgical procedures involving the application of energy to tissue. The modular surgical housing includes a first energy generator module configured to generate a first energy for application to tissue, and a first docking bay including a first docking port including first data and power contacts, wherein the first energy generator module is slidably movable into electrical engagement with the power and data contacts, and wherein the first energy generator module is slidably movable out of electrical engagement with the first power and data contacts,

[0381] Further to the above, the modular surgical housing further includes a second energy generator module configured to generate a second energy different from the first energy for application to tissue, and a second docking bay including a second docking port including second data and power contacts, wherein the second energy generator module is slidably movable into electrical engagement with the power and data contacts, and wherein the second energy generator is slidably movable out of electrical contact with the second power and data contacts.

[0382] Further, the modular surgical housing further includes a communication bus between the first docking port and the second docking port configured to facilitate communication between the first energy generator module and the second energy generator module.

[0383] In one aspect, the present disclosure provides a generator configured to drive a combined ultrasonic / bipolar RF energy surgical device. Figure 93 An example of a generator 3900 according to at least one aspect of the present disclosure is shown. As shown, the generator 3900 is a form of generator configured to be coupled to the surgical instruments 100, 150, 190 as described above, and further configured to drive the surgical instruments 100, 150, 190 as described above. Figure 93 Figures 86-92 Figure 92 ​​Adaptive ultrasonic and electrosurgical control algorithms are executed in the surgical data network of the illustrated modular communication hub. The generator 3900 is configured to deliver multiple energy modalities to surgical instruments. The generator 3900 provides RF and ultrasonic signals for delivery to surgical instruments, either independently or simultaneously. The RF and ultrasonic signals can be provided separately or in combination, and can be provided simultaneously. As described above, at least one generator output can deliver multiple energy modalities (e.g., ultrasonic, 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 separately or simultaneously to an end effector to treat tissue. The generator 3900 includes a processor 3902 coupled to a waveform generator 3904. The processor 3902 and the waveform generator 3904 are configured to generate multiple signal waveforms based on information stored in a memory coupled to the processor 3902, which is not shown for clarity of the present disclosure. Digital information associated with a waveform is provided to the waveform generator 3904, which includes one or more DAC circuits to convert the digital input into an analog output. The analog output is fed 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 through the power transformer 3908 to the secondary side in the patient isolation side. A first signal of a first energy modality is provided to a surgical instrument between the terminals labeled ENERGY1 and RETURN. A second signal of a second energy modality is coupled across a capacitor 3910 and is provided to the surgical instrument between the terminals labeled ENERGY2 and RETURN. It will be appreciated that more than two energy modalities can be output, and thus the subscript“n” can be used to designate that up to n ENERGYn terminals can be provided, where n is a positive integer greater than one. It will also be appreciated that up to“n” return paths RETURNn can be provided without departing from the scope of the present disclosure.

[0384] The first voltage sense circuit 3912 is coupled across the terminals labeled ENERGY1 and RETURN path to measure the output voltage therebetween. The second voltage sense circuit 3924 is coupled across the terminals labeled ENERGY2 and RETURN path to measure the output voltage therebetween. As shown, the current sense circuit 3914 is disposed in series with the RETURN leg of the secondary side of the power transformer 3908 to measure the output current for either energy modality. If different return paths are provided for each energy modality, a separate current sense circuit should be provided in each return leg. The outputs of the first and second voltage sense circuits 3912, 3924 are provided to respective isolation transformers 3916, 3922, 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 outputs of the ADC circuits 3926 are provided to the processor 3902 for further processing and computation. The output voltage and current feedback information can be employed to regulate the output voltage and current provided to the surgical instrument, and to compute output impedance and other parameters. Input / output communication between the processor 3902 and the patient isolated circuitry is provided through the interface circuit 3920. Sensors can also be in electrical communication with the processor 3902 through the interface circuit 3920.

[0385] In one aspect, the impedance can be determined by the processor 3902 by dividing the output of the first voltage sense circuit 3912 coupled across the terminals labeled ENERGY1 / RETURN or the second voltage sense circuit 3924 coupled across the terminals labeled ENERGY2 / RETURN by the output of the current sense circuit 3914 disposed in series with the RETURN leg of the secondary side of the power transformer 3908. The outputs of the first and second voltage sense circuits 3912, 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. The digitized voltage and current sense measurements from the ADC circuits 3926 are provided to the processor 3902 for computation of impedance. For example, the first energy modality ENERGY1 can be ultrasonic energy, and the second energy modality ENERGY2 can be RF energy. However, other energy modalities include irreversible and / or reversible electroporation and / or microwave energy, among others, in addition to ultrasonic and bipolar or monopolar RF energy modalities. Also, while the power transformer 3908 is shown as a single transformer, separate transformers can be provided for each energy modality. Figure 93The illustrated example shows that a single return path RETURN can be provided for two or more energy modalities, but in other aspects, multiple return paths RETURNn can be provided for each energy modality ENERGYn. Thus, as described herein, the ultrasonic transducer impedance can be measured by dividing the output of the first voltage sensing circuit 3912 by the output of the current sensing circuit 3914, and the tissue impedance can be measured by dividing the output of the second voltage sensing circuit 3924 by the output of the current sensing circuit 3914.

[0386] As Figure 93 As shown in FIG. 39, a generator 3900 including at least one output port can include a power transformer 3908 having a single output and multiple taps to provide power to an end effector in the form of one or more energy modalities, such as ultrasonic, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, etc., for example, depending on the type of tissue treatment being performed. For example, the generator 3900 can deliver energy at a higher voltage and lower current to drive an ultrasonic transducer, at a lower voltage and higher current to drive an RF electrode for sealing tissue, or at a coagulation waveform for spot coagulation using a monopolar or bipolar RF electrosurgical electrode. The output waveforms from the generator 3900 can be manipulated, switched, or filtered to provide the frequency to the end effector of the surgical instrument. The connection of the ultrasonic transducer to the output of the generator 3900 would preferably be between the outputs labeled ENERGY1 and RETURN, as shown in FIG. 39. In one example, the connection of the RF bipolar electrode to the output of the generator 3900 would preferably be between the outputs labeled ENERGY2 and RETURN. In the case of a monopolar output, the preferred connections would be the active electrode (e.g., pencil or other probe) of the ENERGY2 output and a suitable return pad connected to the RETURN output. Figure 92

[0387] Additional details are disclosed in U.S. Patent Application Publication No. 2017 / 0086914, entitled “TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS,” published March 30, 2017, which is incorporated by reference herein in its entirety.

[0388] In one aspect, the present disclosure provides a modular energy system configured to be able to drive a combined ultrasonic / bipolar RF energy surgical device. Figure 94 is a diagram of a variety of modules and other components that can be combined to customize a modular energy system in accordance with at least one aspect of the present disclosure.​Figure 95A is a first example modular energy system configuration according to at least one aspect of the present disclosure, including a head module and a display screen presenting a graphical user interface (GUI) for relaying information about modules connected to the head module. Figure 95B is a modular energy system mounted to a cart according to at least one aspect of the present disclosure. Figure 95A is a modular energy system mounted to a cart according to at least one aspect of the present disclosure.

[0389] Reference is now made to Figures 93-95B Due to the number of devices required to perform a surgical procedure, ORs in every part of the world are a tangled web of cords, devices, and people. Surgical capital equipment tends to be a major contributor to this problem, as most surgical capital equipment performs a single specialized task. Due to its specialized nature, and because a surgeon needs to use multiple different types of devices during the course of a single surgical procedure, an OR can be forced to keep two or even more surgical capital devices (such as energy generators) on standby. Each of these surgical capital devices must be plugged into a power source separately, and can be connected to one or more other devices that pass between OR personnel, creating a tangle of cords that must be navigated. Another problem faced in modern ORs is that each of these specialized surgical capital devices has its own user interface, and must be controlled independently of other equipment within the OR. This creates complexity in properly controlling multiple different devices connected to one another, and forces users to accept training and to remember different types of user interfaces (which can change based on the task or surgical procedure being performed, in addition to changing between each capital device). This cumbersome, complex process can require more personnel to be stationed within the OR, and can create hazards if multiple devices cannot be properly controlled in tandem with one another. Therefore, consolidating surgical capital equipment technology into a single system that can flexibly meet the needs of surgeons to reduce the footprint of surgical capital equipment within the OR would simplify the user experience, reduce the chaos in the OR, and prevent the difficulties and hazards associated with controlling multiple capital devices at once. Furthermore, making such a system scalable or customizable would allow new technologies to be incorporated into the existing surgical system with ease, without requiring the entire surgical system to be replaced, and without requiring OR personnel to learn new user interfaces or device controls for each new technology.

[0390] A surgical hub can be configured to interchangeably receive a variety of modules, which in turn can interact with surgical devices (e.g., surgical instruments or smoke evacuators) or provide various other functionality (e.g., communication). In one aspect, a surgical hub can be embodied as a combination of Figures 94-95BA modular energy system 4000 is shown. The modular energy system 4000 can include a variety of different modules 4001 that can be connected together in a stacked configuration. In one aspect, the modules 4001 can be physically and communicably coupled together when stacked or otherwise connected together to form a single assembly. Further, the modules 4001 can be interchangeably connected together in different combinations or arrangements. In one aspect, each of the modules 4001 can include a uniform or universal array of connectors disposed along its upper and lower surfaces, allowing any module 4001 to be connected to another module 4001 in any arrangement (except that, in some aspects, certain module types, such as a header module 4002, can be configured to be usable as, for example, the uppermost module within a stack). In one alternative aspect, the modular energy system 4000 can include a housing configured to receive and hold the modules 4001, as shown. The modular energy system 4000 can also include a variety of different components or accessories that are also connectable to or otherwise associated with the modules 4001. In another aspect, the modular energy system 4000 can be embodied as the generator module 3140, 3900 of the surgical hub 3106 Figure 92 . In yet another aspect, the modular energy system 4000 can be a system that is distinct from the surgical hub 3106. In such aspects, the modular energy system 4000 can be communicably coupled to the surgical hub 3106 for the transmission and / or receipt of data therebetween. Figures 92-93

[0391] The modular energy system 4000 can be assembled from a variety of different modules 4001, some examples of which are shown in FIGS. 40A-40C. In one aspect, the modules 4001 can be physically and communicably coupled together when stacked or otherwise connected together to form a single assembly. Further, the modules 4001 can be interchangeably connected together in different combinations or arrangements. In one aspect, each of the modules 4001 can include a uniform or universal array of connectors disposed along its upper and lower surfaces, allowing any module 4001 to be connected to another module 4001 in any arrangement (except that, in some aspects, certain module types, such as a header module 4002, can be configured to be usable as, for example, the uppermost module within a stack). In one alternative aspect, the modular energy system 4000 can include a housing configured to receive and hold the modules 4001, as shown. The modular energy system 4000 can also include a variety of different components or accessories that are also connectable to or otherwise associated with the modules 4001. In another aspect, the modular energy system 4000 can be embodied as the generator module 3140, 3900 of the surgical hub 3106 Figure 94 ​Each of the different types of modules 4001 can provide different functionality, allowing the modular energy system 4000 to be assembled into 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 head module 4002 (which can include a display screen 4006), an energy module 4004, a technology module 4040, and a visualization module 4042. In the illustrated aspect, the head module 4002 is configured to be able to function as a top or uppermost module within a stack of modular energy systems, and thus can be free of connectors along its top surface. In another aspect, the head module 4002 can be configured to be able to be positioned at a bottom or lowermost module within a stack of modular energy systems, and thus can be free of connectors along its bottom surface. In yet another aspect, the head module 4002 can be configured to be able to be positioned at an intermediate position within a stack of modular energy systems, and thus can include connectors along both its bottom surface and its top surface. The head module 4002 can be configured to control system-level settings of each module 4001 and components connected thereto through physical controls 4011 on the head module and / or a graphical user interface (GUI) 4008 presented on the display screen 4006. Such settings can include activation of the modular energy system 4000, an amount of alarms, footswitch settings, a set icon, an appearance or configuration of the user interface, a surgeon profile logged into the modular energy system 4000, and / or a type of surgical procedure being performed. The head module 4002 can also be configured to provide communication, processing, and / or power to the modules 4001 connected to the head module 4002. The energy module 4004 (which can also be referred to as a generator module 3140, 3900 Figures 92-93 )) can be configured to generate one or more energy modalities for driving electrosurgical instruments and / or ultrasonic surgical instruments connected with the energy module, such as described above in connection with the generators 3900 shown in FIGS. 28-29. The technology module 4040 can be configured to provide additional or extended control algorithms (e.g., electrosurgical control algorithms or ultrasonic control algorithms for controlling energy output of the energy module 4004). The visualization module 4042 can be configured to interface with a visualization device (i.e., a viewing apparatus), and thus improve visualization capabilities. Figure 93

[0392] ​The modular energy system 4000 can also include a variety of accessories 4029 that can be connected to the modules 4001 for controlling their functions, or otherwise configured to work in conjunction with the modular energy system 4000. The accessories 4029 can 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 can be configured to control, for example, activation or functions of a particular energy modality output by the energy module 4004.

[0393] By utilizing modular components, the depicted modular energy system 4000 provides a surgical platform that is optimized as technology becomes available and can be customized to the needs of the facility and / or surgeon. Further, the modular energy system 4000 supports combined devices (e.g., dual electrosurgical and ultrasonic energy generators) and supports software driven algorithms for customizing tissue effects. Further, the surgical system architecture reduces capital footprint by combining multiple technologies essential to surgical procedures into a single system.

[0394] The various modular components that can be used in conjunction with the modular energy system 4000 can include a monopolar energy generator, a bipolar energy generator, a dual electrosurgical / ultrasonic energy generator, a display screen, as well as various other modules and / or other components, some of which are also described above in connection with the modular energy system 1000. Figures 1-91

[0395] Referring now to Figure 95A ​In some aspects, head module 4002 may include a display screen 4006 that presents a GUI 4008 for relaying information about modules 4001 connected to head module 4002. In some aspects, the GUI 4008 of display screen 4006 may provide a unified control point for all modules 4001 constituting a particular configuration of the modular power system 4000. In another aspect, head module 4002 may not include display screen 4006, or display screen 4006 may be detachably attached to housing 4010 of head module 4002. In such aspects, head module 4002 can be communicatively coupled to an external system configured to display information generated by modules 4001 of modular power system 4000. For example, in robotic surgical applications, modular power system 4000 can be communicatively coupled to a robot cart or robot console configured to display information generated by modular power system 4000 to an operator of the robotic surgical system. For example, the modular power system 4000 can be communicatively coupled to a mobile display that can be carried or attached to a surgical staff member for viewing. In yet another example, the modular power system 4000 can be communicatively coupled to a surgical hub 4100 or another computer system that may include a display 4104. Regarding the use of a user interface separate from or otherwise different from the modular power system 4000, the user interface can be wirelessly connected to the modular power system 4000 as a whole or to one or more modules 4001 thereon, allowing the user interface to display information from the connected module 4001.

[0396] See still Figure 95A The energy module 4004 may include a port assembly 4012 comprising a plurality of different ports configured to deliver different energy modes to corresponding surgical instruments that can be connected thereto. Figures 94-95B In a specific aspect shown, port assembly 4012 includes a bipolar port 4014, a first unipolar port 4016a, a second unipolar port 4018b, a neutral electrode port 4018 (to which a unipolar return pad can be connected), and a combined energy port 4020. However, this particular combination of ports is merely illustrative, and alternative combinations of ports and / or energy modes are possible for port assembly 4012.

[0397] As described above, the modular energy system 4000 can be assembled into different configurations. Furthermore, different configurations of the modular energy system 4000 can also be used for different types of surgical procedures and / or different tasks. For example, Figure 95A and Figure 95BA first exemplary configuration of the modular energy system 4000 is shown, which includes a head module 4002 (including a display 4006) and an energy module 4004 connected together. Such a configuration is suitable for, for example, laparoscopic and open surgical procedures.

[0398] Figures 96-100 An exemplary surgical system 10 with ultrasonic and electrosurgical features is shown, comprising any of the end effectors, surgical instruments, and generators described herein. Figure 96 A surgical system 10 is shown, comprising a generator 12 and surgical instruments 14. The surgical instruments 14 are operatively connected to the generator 12 via a power cable 16. The generator 12 is operable to power the surgical instruments 14 to deliver ultrasonic energy for cutting tissue and electrosurgical bipolar RF energy (i.e., therapeutic level RF energy) for sealing tissue. In one aspect, the generator 12 is configured to power the surgical instruments 14 to deliver ultrasonic energy and electrosurgical bipolar RF energy simultaneously or independently.

[0399] 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 comprising a pistol-grip 26 and energy control buttons 28, 30 configured for operation by a surgeon. A trigger 32 is coupled to a lower portion of the body 24 and 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 disposed externally to the body 24.

[0400] like Figure 97 and Figure 98 As shown, the end effector 22 includes an ultrasonic scalpel 36 and a clamping arm 38 configured to selectively pivot toward and away from the ultrasonic scalpel 36 to clamp tissue therebetween. The ultrasonic scalpel 36 is acoustically coupled to an ultrasonic transducer 34 configured to drive (i.e., vibrate) the ultrasonic scalpel 36 at an ultrasonic frequency for cutting and / or sealing tissue positioned in contact with the ultrasonic scalpel 36. The clamping arm 38 is operatively coupled to a trigger 32 such that the clamping arm 38 is configured to pivot toward the ultrasonic scalpel 36 to a closed position in response to pivoting of the trigger 32 toward the pistol grip 26. Additionally, the clamping arm 38 is configured to pivot away from the ultrasonic scalpel 36 to an open position in response to pivoting of the trigger 32 away from the pistol grip 26 (see, for example...). Figures 96-98Given the teachings presented herein, various suitable ways of connecting the clamping arm 38 to the trigger 32 will be apparent to those skilled in the art. In some configurations, one or more resilient members may be incorporated to bias the clamping arm 38 and / or the trigger 32 toward the open position.

[0401] A clamping pad 40 is attached to the clamping side of the clamping arm 38 facing the ultrasonic scalpel 36 and extends distally along that clamping side. The clamping pad 40 is configured to engage and clamp tissue against a corresponding tissue processing portion of the ultrasonic scalpel 36 when the clamping arm 38 is actuated to its closed position. At least one clamping side of the clamping arm 38 provides a first electrode 42, referred to herein as clamping arm electrode 42. Additionally, at least one clamping side of the ultrasonic scalpel 36 provides a second electrode 44, referred herein as scalpel electrode 44. Electrodes 42, 44 are configured to apply electrosurgical bipolar RF energy provided by generator 12 to tissue electrically connected to electrodes 42, 44. The clamping arm electrode 42 may be used as an active electrode, while the scalpel electrode 44 may be used as a return electrode, or vice versa. The surgical instrument 14 may be configured to apply electrosurgical bipolar RF energy through electrodes 42, 44 while, before, and / or after the ultrasonic scalpel 36 vibrates at an ultrasonic frequency.

[0402] like Figures 96-100 As shown, 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 conductor 50 supported within the inner tube 48. Figures 97-100 Ideally, the clamping arm 38 is coupled to the distal ends of the inner tube 48 and the outer tube 46. Specifically, the clamping arm 38 includes a pair of proximal connecting forks 52, which are received and pivotally coupled to the distal end 54 of the inner tube 48 therebetween, wherein a pivot pin 56 is received through a hole formed in the connecting forks 52 and the distal end 54 of the inner tube 48. A first connecting fork and a second connecting fork 58 extend downward from the connecting forks 52 and are pivotally coupled to the distal end 60 of the outer tube 46. Specifically, each connecting fork 58 includes a protrusion 62 that is rotatably received within a corresponding opening 64 formed in the sidewall of the distal end 60 of the outer tube 46.

[0403] In the present example, the inner tube 48 is longitudinally fixed relative to the handle assembly 18, and the outer tube 46 is configured to be translatable 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 is translated distally, the clamp arm 38 is pivoted about the pivot pin 56 toward its open position. As the outer tube 46 is translated proximally, the clamp arm 38 is pivoted in the opposite direction toward its closed position. The proximal end of the outer tube 46 is operatively coupled with the trigger 32, e.g., via a linkage assembly, such that actuation of the trigger 32 causes the outer tube 46 to translate relative to the inner tube 48, thereby causing the clamp arm 38 to open or close. In other suitable configurations not shown herein, the outer tube 46 can be longitudinally fixed, and the inner tube 48 can be configured to be translatable for moving the clamp arm 38 between its open and closed positions.

[0404] The shaft assembly 20 and the end effector 22 are configured to be rotatable together about the longitudinal axis relative to the handle assembly 18. Figure 99 The illustrated retention pin 66 extends transversely through the proximal portions of the outer tube 46, the inner tube 48, and the waveguide 50, thereby rotationally coupling these components relative to one another. In the present example, a knob 68 is provided at the 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 knob 68 is rotationally fixed to the shaft assembly 20 with the retention pin 66, which extends through a proximal collar of the knob 68. It will be appreciated that in other suitable configurations, the knob 68 can be omitted or replaced by an alternative rotational actuation structure.

[0405] The ultrasonic waveguide 50 is acoustically coupled at its proximal end to the ultrasonic transducer 34, e.g., by a threaded connection, and at its distal end to the ultrasonic blade 36, as Figure 100As shown, the ultrasonic scalpel 36 is integrally formed with the waveguide 50, such that the scalpel 36 extends directly distally from the distal end of the waveguide 50. Thus, the waveguide 50 acoustically connects the ultrasonic transducer 34 to the ultrasonic scalpel 36 and serves to transmit ultrasonic mechanical vibrations from the transducer 34 to the scalpel 36. Therefore, the ultrasonic transducer 34, the waveguide 50, and the ultrasonic scalpel 36 together define an acoustic assembly. During use, with or without the auxiliary clamping force provided by the clamping arm 38, the ultrasonic scalpel 36 can be positioned in direct contact with tissue to impart ultrasonic vibrational energy to the tissue and thereby cut and / or seal it. For example, the scalpel 36 can cut through tissue clamped between the clamping arm 38 and a first treatment side of the scalpel 36, or the scalpel 36 can cut through tissue, for example, tissue positioned in contact with a second treatment side opposite to the scalpel 36 during a "back-cut" movement. In some variations, the waveguide 50 can amplify the ultrasonic vibrations delivered to the scalpel 36. Additionally, waveguide 50 may include various features operable to control vibration gain, and / or features adapted to tune waveguide 50 to a selected resonant frequency. The additional features of the ultrasonic scalpel 36 and waveguide 50 are described in more detail below.

[0406] Waveguide 50 is supported within inner tube 48 by a plurality of nodal support elements 70 positioned along the length of waveguide 50, such as Figures 99-100 As shown. Specifically, the node support element 70 is positioned longitudinally along the waveguide 50 at a location corresponding to an acoustic node defined by the resonant ultrasonic vibration transmitted through the waveguide 50. The node support element 70 can provide structural support to the waveguide 50 and provide acoustic isolation between the waveguide 50 and the inner tube 48 and outer tube 46 of the shaft assembly 20. In a variant, the node support element 70 may include an O-ring. The waveguide 50 is supported at its distalest acoustic node by... Figure 100 The waveguide 50 is supported by a node support element in the form of a molded member 72. The waveguide 50 is longitudinally and rotatably secured within the shaft assembly 20 by a retaining pin 66 that passes through a transverse through-hole 74 formed in the waveguide 50 at a proximal acoustic node, such as, for example, the nearest acoustic node.

[0407] In this example, the distal end 76 of the ultrasonic scalpel 36 is located at a position corresponding to an antinode associated with the resonant ultrasonic vibration transmitted through the waveguide 50. This configuration allows the acoustic components of the instrument 14 to be tuned to a preferred resonant frequency f when the ultrasonic scalpel 36 is not loaded with tissue. o When the ultrasonic transducer 34 is powered by the generator 12 to transmit mechanical vibrations through the waveguide 50 to the blade 36, the distal end 76 of the blade 36 is caused to oscillate longitudinally, for example, in a peak-to-peak range of approximately 20 to 120 micrometers, and in some cases, at a predetermined vibration frequency f of approximately 50 kHz. oLongitudinally oscillate in the range of about 20 microns to 50 microns. When the ultrasonic blade 36 is positioned in contact with tissue, the ultrasonic oscillations of the blade 36 can simultaneously sever the tissue and denature the proteins in adjacent tissue cells, providing a coagulation effect with minimal thermal diffusion.

[0408] Example

[0409] Embodiments of various aspects of end effectors and surgical instruments of the present disclosure are provided below. One aspect of an end effector or surgical instrument can include any one or more of the following embodiments and any combination thereof:

[0410] Embodiment 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 a generator; wherein the clamp arm comprises: a clamp jaw; a cantilevered electrode configured to electrically couple to an opposite pole of the generator, wherein the cantilevered electrode is fixed to the clamp jaw at a proximal end and is free to deflect at a distal end; and wherein the clamp arm comprises a control feature to adjust a tissue path relative to the clamp arm to form a predetermined contact location.

[0411] Embodiment 2. The end effector of embodiment 1, wherein the control feature is configured to reduce charring and tissue sticking to the clamp arm.

[0412] Embodiment 3. The end effector of any one of embodiments 1-2, wherein the clamp jaw comprises raised sidewalls to encircle the cantilevered electrode, preventing exposure and preventing tissue from entering a region inside the raised sidewalls.

[0413] Embodiment 4. The end effector of embodiment 3, wherein the raised sidewalls encircling the cantilevered electrode are extruded and surround the clamp arm pad.

[0414] Embodiment 5. The end effector of any one of embodiments 1-4, wherein the clamp arm pad comprises exposed teeth to prevent tissue from entering a region inside the exposed teeth.

[0415] Embodiment 6. The end effector of any one of embodiments 1-5, wherein the clamp jaw comprises raised sidewalls and raised lips to prevent tissue from accumulating inside the raised sidewalls and raised lips.

[0416] Embodiment 7. The end effector of embodiment 6, wherein the clamp arm pad comprises a plurality of teeth.

[0417] Example 8. An end effector comprising: a clamp arm; and an ultrasonic blade configured to acoustically couple to an ultrasonic transducer and electrically couple to one pole of a generator; wherein the clamp arm comprises: a clamp jaw; a cantilevered electrode configured to electrically couple to an opposite pole of the generator, wherein the cantilevered electrode is fixed to the clamp jaw at a proximal end and is free to deflect at a distal end; and wherein the clamp arm comprises a control feature to adjust a tissue path relative to the ultrasonic blade to form a predetermined contact location.

[0418] Example 9. The end effector of Example 8, wherein the control feature is configured to reduce charring and tissue sticking to the ultrasonic blade.

[0419] Example 10. The end effector of any of Examples 8-9, wherein the clamp jaw comprises a shield to encircle the cantilevered electrode to prevent exposure and prevent tissue from entering an area inside the shield.

[0420] Example 11. The end effector of Example 10, wherein the shield encircling the cantilevered electrode is extruded and surrounds the clamp arm pad.

[0421] Example 12. The end effector of any of Examples 8-11, wherein the clamp arm pad comprises exposed teeth to prevent tissue from entering an area inside the exposed teeth.

[0422] Example 13. The end effector of any of Examples 8-12, wherein the clamp jaw comprises a shield and a raised lip to prevent tissue from accumulating inside the shield and the raised lip.

[0423] Example 14. The end effector of Example 13, wherein the clamp arm pad comprises a plurality of teeth.

[0424] Example 15. A surgical instrument comprising: a housing; an ultrasonic transducer; and an end effector comprising: a clamp arm; and an ultrasonic blade configured to acoustically couple to the ultrasonic transducer and electrically couple to one pole of a generator; wherein the clamp arm comprises: a clamp jaw; a cantilevered electrode configured to electrically couple to an opposite pole of the generator, wherein the cantilevered electrode is fixed to the clamp jaw at a proximal end and is free to deflect at a distal end; and wherein the clamp arm comprises a control feature to adjust a tissue path relative to the clamp arm and the ultrasonic blade to form a predetermined contact location.

[0425] Example 16. The surgical instrument of Example 15, wherein the control feature is configured to reduce tissue charring and tissue sticking to the clamp arm or the ultrasonic blade.

[0426] Example 17. The surgical instrument of any of Examples 15-16, wherein the clamp includes raised sidewalls or guards to encircle the cantilevered electrode, thereby preventing exposure and preventing tissue from entering the area inside the raised sidewalls or guards.

[0427] Example 18. The surgical instrument of Example 17, wherein the raised sidewalls or guards encircling the cantilevered electrode are extruded and surround the clamp arm pad.

[0428] Example 19. The surgical instrument of any of Examples 15-18, wherein the clamp arm pad includes exposed teeth to prevent tissue from entering the area inside the exposed teeth.

[0429] Example 20. The surgical instrument of any of Examples 15-19, wherein the clamp includes raised sidewalls or guards and raised lips to prevent tissue from accumulating inside the raised sidewalls or guards and raised lips.

[0430] Example 21. The surgical instrument of Example 20, wherein the clamp arm pad includes a plurality of teeth.

[0431] While a number of forms have been illustrated and described, it is not the intention of the Applicant to restrict or limit the scope of the appended claims to such detail. Numerous modifications, alterations, variations, combinations, and equivalents will become apparent to those skilled in the art in view of the disclosure, and it is contemplated that such modifications, alterations, variations, combinations, and equivalents are within the scope of the disclosure. Further, other alternative structures associated with each element described can be described as means for providing the function performed by the described element. Additionally, where materials are disclosed for certain components, other materials can be used. Thus, it is intended that the presently disclosed implementations cover all such modifications, combinations, and variations as come within the scope of the disclosure. Accordingly, the appended claims and their equivalents are intended to cover all such modifications, variations, changes, substitutions, modifications, and equivalents.

[0432] The detailed description set forth above describes various forms of the application in connection with the illustrative embodiments. It is to be understood that the terms "example," "exemplary," "for example," or the like are not used to mean that a particular aspect or aspect only is illustrated. Rather, these terms mean or intend to convey that the aspect is among various aspects to be considered in connection with the application. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The term "or" means "and / or" unless the context clearly dictates otherwise. The term "comprises" means "includes or is inclusive of, but not limited to" and allows for the possibility that other elements can be present in addition to those recited. The term "comprising" encompasses the terms "consisting of" and "consisting essentially of." The term "consisting essentially of" means that additional elements can be present in addition to those recited, but the additional elements do not materially alter the basic and novel characteristics of the application. The term "consisting of" means an exclusive list in which no additional elements can be present.

[0433] Instructions used to program logic to perform various disclosed aspects can be stored within a memory in the system, such as dynamic random access memory (DRAM), cache, flash memory, or other memory. Furthermore, instructions can be distributed via a network or by way of other computer readable media. Thus, a machine-readable medium can include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), but is not limited to, soft disks, optical disks, magnetic disks or tapes, optical disks, read-only memory (ROM), random access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), magnetic or optical cards, flash memory, or a tangible, machine-readable storage used in the transmission of information over the Internet via electrical, optical, acoustical or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Accordingly, non-transitory machine-readable medium includes any type of tangible machine-readable medium, except for a transitory propagating signal.

[0434] As used in any aspect herein, the term “control circuitry” can refer to, be implemented by, or otherwise be comprised of, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor including one or more individual instruction processing cores, processing units, processors, microcontrollers, microcontroller units, controllers, digital signal processors (DSPs), programmable logic devices (PLDs), programmable logic arrays (PLAs), field programmable gate arrays (FPGAs)), state machine circuitry, firmware that stores instructions executed by programmable circuitry, and any combination thereof. The control circuitry can be implemented, as a whole or part, as circuitry forming a portion of a larger system, such as 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 smart phone, and the like. As such, “control circuitry,” as used herein, includes, but is not limited to, electronic circuitry having a plurality of discrete electronic components, electronic circuitry having a plurality of integrated circuit devices, electronic circuitry having a plurality of application-specific integrated circuit devices, electronic circuitry forming a general-purpose computing device configured by a computer program (e.g., a general-purpose computer configured by computer program code to perform the methods and / or devices described herein, or a microprocessor configured by computer program code to perform the methods and / or devices described herein), electronic circuitry forming a memory device (e.g., forming a random access memory), and / or electronic circuitry forming a communications device (e.g., a modem, a communications switch, or an opto-electronic device). Those skilled in the art will recognize that the subject matter described herein can be implemented in an analog or digital fashion or some combination thereof.

[0435] As used in any aspect herein, the term “logic” can refer to an application program, software, firmware, and / or circuitry configured to enable, cause or conduct any of the foregoing operations. Software can be embodied as a software package, code, instructions, instruction sets, and / or data recorded in one or more non-transitory computer-readable storage media. Firmware can be embodied as code, instructions, or instruction sets and / or data that are hard-coded (e.g., non-volatile) in memory devices.

[0436] As used in any aspect herein, the terms “component,” “system,” “module” and the like can refer to or be comprised of computer-related entities, hardware, combinations of hardware and software, software, or software in execution.

[0437] As used in any aspect herein, an “algorithm” refers to a self-consistent sequence of steps leading to a desired result, where a “step” refers to a manipulation of physical quantities and / or logic states, which may, but need not, take the form of electrical or magnetic signals, that may, but need not, be stored, transferred, combined, compared, and otherwise manipulated in a computer system or similar electronic computing device. Commonly used terms such as bits, values, elements, symbols, characters, terms, numbers, and the like, can be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities.

[0438] The network can include a packet-switched network. The communication devices can be capable of communicating with each other using a selected packet-switched network communication protocol. One example communication protocol can include an Ethernet communication protocol that can be capable of allowing communication using the Transmission Control Protocol / Internet Protocol (TCP / IP). The Ethernet protocol can conform to or be compatible with the Ethernet standard entitled “IEEE 802.3 Standard” published by the Institute of Electrical and Electronics Engineers (IEEE) in December 2008 and / or a later version of this standard. Alternatively or additionally, the communication devices can be capable of communicating with each other using an X.25 communication protocol. The X.25 communication protocol can conform to or be compatible with a standard published by the International Telecommunication Union Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, the communication devices can be capable of communicating with each other using a Frame Relay communication protocol. The Frame Relay communication protocol can conform to or be compatible with a standard published by the Consultative Committee International Telegraph and Telephone (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers can be capable of communicating with each other using an Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol can conform to or be compatible with the ATM standard entitled “ATM-MPLS Network Interworking 2.0” published by the ATM Forum in August 2001 and / or a later version of this standard. Of course, different and / or later developed connection-oriented network communication protocols are likewise contemplated herein.

[0439] Unless specifically stated otherwise as apparent from the above disclosure, it is appreciated that, throughout described disclosure, discussions using terms such as “processing,” “computing,” “calculating,” “determining,” “displaying,” or the like, can refer to the action and processes of a computer system, or similar electronic

[0440] One or more components can be referred to herein as being“configured to,”“configurable to,”“operable / operable to,”“adapted to / adaptable to,”“capable of,”“suitable to / suitable for,”“to be adapted to / adapted to,” or the like. Those skilled in the art will recognize that, as used herein, “configured to” can cover active- state means d e / and / or inactive-state means d e / and / or standby state means d e.

[0441] The terms“proximal” and“distal” are used herein with respect to a clinician manipulating a handle portion of a surgical instrument. The term“proximal” refers to the portion closest to the clinician, and the term“distal” refers to the portion positioned away from the clinician. It will also be appreciated that, for conciseness and clarity, spatial terms such as“vertical,”“horizontal,”“up,” and“down,” can be used herein with respect to the accompanying drawings. However, surgical instruments are employed in many orientations and positions, and the terms are not intended to be limiting and / or absolute.

[0442] Those skilled in the art will recognize that, in general, the terms used herein, and particularly in the appended claims (e.g., in the body of the appended claims), are intended to be“open” terms (e.g., the term“including” is intended to be interpreted as“including but not limited to,” the term“having” is intended to be interpreted as“having at least,” the term“includes” is intended to be interpreted as“includes, but is not limited to,” etc.). Those skilled in the art will also recognize that, unless otherwise specified, a specific number of an introduced claim expression is not intended to be limiting, and in the absence of such recitation, no such intent exists. For example, to aid in understanding, the following appended claims can contain the use of the introductory phrases“at least one” and“one or more” to introduce claim expressions. However, the use of such phrases should not be taken to imply that the use of indefinite articles“a” or“an” to introduce claim expressions is limiting any particular claim to contain only one such expression, even when the same claim includes the introductory phrases“one or more” or“at least one” and indefinite articles such as“a” or“an” (e.g.,“a” and / or“an” should generally be interpreted to mean“at least one” or“one or more”); this also applies to the use of definite articles to introduce claim expressions.

[0443] Furthermore, even when a specific number of claims is explicitly stated, those skilled in the art should recognize that such a statement should generally be interpreted as referring to at least the number stated (e.g., in the absence of other modifiers, a bare statement of "two statements" generally means at least two statements, or two or more statements). Moreover, in cases where conventions such as "at least one of A, B, and C" are used, such constructions are generally intended to have a meaning that those skilled in the art will understand (e.g., "a system having at least one of A, B, and C" will include, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In cases where conventions such as "at least one of A, B, or C" are used, such constructions are generally intended to have a meaning that those skilled in the art will understand (e.g., "a system having at least one of A, B, or C" should include, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). Those skilled in the art should also understand that, generally, unless the context otherwise indicates, any transitional words and / or phrases presenting two or more alternative terms in the detailed description, claims, or drawings should be understood to cover the possibility of including one of the terms, any one of the terms, or both of the terms. For example, the phrase "A or B" will generally be understood to include the possibility of "A" or "B" or "A and B".

[0444] With respect to the appended claims, those skilled in the art will understand that the operations described herein can generally be performed in any order. Furthermore, although various operation flowcharts are shown in one or more sequences, it should be understood that the various operations may be performed in other orders than those shown, or may be performed simultaneously. Unless the context otherwise requires, examples of such alternative orderings may include overlapping, interleaving, interruption, reordering, incremental, preparatory, supplementary, simultaneous, reverse, or other altered orderings. Moreover, unless the context otherwise requires, terms such as “in response to,” “related,” or other past tense adjectives are generally not intended to exclude such variations.

[0445] It is worth noting that any reference to "one aspect," "one aspect," "one example," or "one example" means that the specific feature, structure, or characteristic described in connection with said aspect is included in at least one aspect. Therefore, the phrases "in one aspect," "in one aspect," "in one example," and "in one example" appearing in various places throughout the specification do not necessarily refer to the same aspect. Furthermore, specific features, structures, or characteristics may be combined in one or more aspects in any suitable manner.

[0446] Any patent application, patent, non-patent publication, or other disclosure material referred to in this specification, in any application data sheet, or in any other document filed in connection with this application is incorporated by reference herein, only to the extent that the incorporated material is not inconsistent with the explicit teachings of this specification. Accordingly, and to the extent necessary, the disclosure herein supersedes any conflicting material incorporated by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which contradicts the present definition, statement, or other disclosure material set forth herein, is only incorporated to the extent that the material is consistent with the existing disclosure material.

[0447] In general, numerous benefits have been described which result from the techniques described herein. The foregoing specific embodiments have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the application to the precise forms disclosed. Modifications and variations are possible in light of the above teachings or can be acquired from practice of the application. One or more forms have been chosen and described in order to provide a thorough description of the various forms the application can take. Other forms, but using the general principles of the application, can be employed as well. The claims are intended to cover all forms of the application.

Claims

1. An end effector, comprising: Clamping arm; as well as An ultrasonic scalpel, the ultrasonic scalpel being configured to be acoustically connected to an ultrasonic transducer and electrically connected to one pole of a generator; The clamping arm includes: clamp; A clamping arm pad, the clamping arm pad being configured to be physically connected to the clamp; A cantilever electrode, configured to be electrically connected to the opposite pole of the generator, wherein the cantilever electrode is fixed to the clamp at a proximal end and freely deflected at a distal end, and wherein the cantilever electrode includes an opening for receiving the clamping arm pad; and The clamping arm includes a control feature to adjust the tissue path relative to the clamping arm to form a predetermined contact position.

2. The end effector according to claim 1, wherein, The control feature is configured to reduce tissue carbonization and tissue adhesion to the clamping arm, and wherein the control feature includes one or more gap pads.

3. The end effector according to claim 1, wherein, The clamp includes raised sidewalls to surround the cantilever electrode, thereby preventing exposure and preventing tissue from entering the area inside the raised sidewalls.

4. The end effector according to claim 3, wherein, The raised sidewalls surrounding the cantilever electrode are extruded and surround the clamping arm pad.

5. The end effector according to claim 1, wherein, The clamping arm pad includes exposed teeth to prevent tissue from entering the area inside the exposed teeth.

6. The end effector according to claim 1, wherein, The clamp includes raised sidewalls and raised lips to prevent tissue from accumulating inside the raised sidewalls and raised lips.

7. The end effector according to claim 6, wherein, The clamping arm pad includes multiple teeth.

8. An end effector, comprising: Clamping arm; as well as An ultrasonic scalpel, the ultrasonic scalpel being configured to be acoustically connected to an ultrasonic transducer and electrically connected to one pole of a generator; The clamping arm includes: clamp; A clamping arm pad, the clamping arm pad being configured to be physically connected to the clamp; A cantilever electrode, configured to be electrically connected to the opposite pole of the generator, wherein the cantilever electrode is fixed to the clamp at a proximal end and freely deflected at a distal end, and wherein the cantilever electrode includes an opening for receiving the clamping arm pad; and The clamping arm includes a control feature to adjust the tissue path relative to the ultrasonic scalpel to form a predetermined contact position.

9. The end effector according to claim 8, wherein, The control feature is configured to reduce tissue carbonization and tissue adhesion to the ultrasonic scalpel, and wherein the control feature includes one or more gap pads.

10. The end effector according to claim 8, wherein, The clamp includes a protective element surrounding the cantilever electrode to prevent exposure and to prevent tissue from entering the area inside the protective element.

11. The end effector according to claim 10, wherein, The protective element surrounding the cantilever electrode is extruded and surrounds the clamping arm pad.

12. The end effector according to claim 8, wherein, The clamping arm pad includes exposed teeth to prevent tissue from entering the area inside the exposed teeth.

13. The end effector according to claim 8, wherein, The clamp includes a protective element and an elevated lip to prevent tissue from accumulating inside the protective element and the elevated lip.

14. The end effector according to claim 13, wherein, The clamping arm pad includes multiple teeth.

15. A surgical instrument comprising: shell; Ultrasonic transducer; as well as End effector, the end effector comprising: Clamping arms; and An ultrasonic scalpel, the ultrasonic scalpel being configured to be acoustically connected to an ultrasonic transducer and electrically connected to one pole of a generator; The clamping arm includes: clamp; A clamping arm pad, the clamping arm pad being configured to be physically connected to the clamp; A cantilever electrode, configured to be electrically connected to the opposite pole of the generator, wherein the cantilever electrode is fixed to the clamp at a proximal end and freely deflected at a distal end, and wherein the cantilever electrode includes an opening for receiving the clamping arm pad; and The clamping arm includes a control feature to adjust the tissue path relative to the clamping arm or the ultrasonic scalpel to form a predetermined contact position.

16. The surgical instrument according to claim 15, wherein, The control feature is configured to reduce tissue carbonization and tissue adhesion to the clamping arm or the ultrasonic scalpel, and wherein the control feature includes one or more gap pads.

17. The surgical instrument according to claim 15, wherein, The clamp includes raised sidewalls or guards to surround the cantilever electrode, thereby preventing exposure and preventing tissue from entering the area inside the raised sidewalls or guards.

18. The surgical instrument according to claim 17, wherein, The raised sidewall or protective element surrounding the cantilever electrode is extruded and surrounds the clamping arm pad.

19. The surgical instrument according to claim 15, wherein, The clamping arm pad includes exposed teeth to prevent tissue from entering the area inside the exposed teeth.

20. The surgical instrument according to claim 15, wherein, The clamp includes raised sidewalls or guards and raised lips to prevent tissue from accumulating inside the raised sidewalls or guards and the raised lips.

21. The surgical instrument according to claim 20, wherein, The clamping arm pad includes multiple teeth.

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