Asymmetric segmented ultrasound support pad for mating engagement with a movable RF electrode

Abstract

An end effector includes an ultrasonic blade configured to be acoustically coupled to an ultrasonic wave transducer and electrically coupled to one pole of a generator, and a clamp arm including a clamp jaw and a cantilever electrode secured to the clamp jaw. The cantilever electrode is configured to be electrically coupled to an opposite pole of the generator. The clamp arm can include an I-beam shaped clamp arm pad, and the cantilever electrode is disposed between the I-beams. The clamp jaw, the cantilever electrode, and the clamp arm pad can define a recess along a length that coincides with the ultrasonic blade. The clamp arm pad can be secured to the clamp jaw and disposed between the clamp jaw and the cantilever electrode, and can extend beyond a surface of the cantilever electrode. The clamp arm can include a stationary gap setting pad and a movable floating gap setting pad.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 955,292, filed December 30, 2019, entitled “COMBINATION ENERGY MODALITY END-EFFECTOR,” pursuant to 35 U.S.C., Section 119(e), the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure relates generally to an end effector adapted and configured to operate with multiple energy modes, enabling tissue sealing and cutting using energy modes applied simultaneously, independently, or sequentially. More specifically, this disclosure relates to an end effector adapted and configured to operate with surgical instruments employing combined ultrasound and electrosurgical systems, such as monopolar or bipolar radiofrequency (RF), enabling tissue sealing and cutting using ultrasound and electrosurgical energy modes applied simultaneously, independently, or sequentially. Energy modes may be applied based on tissue parameters or other algorithms. The end effector may be adapted and configured to be coupled to a handheld or robotic surgical system. Background Technology

[0004] Ultrasonic surgical instruments utilizing ultrasonic energy modes are increasingly used in surgical procedures due to their unique performance characteristics. Depending on the specific instrument configuration and operating parameters, ultrasonic surgical instruments can substantially simultaneously perform tissue cutting and hemostasis through coagulation, thereby advantageously minimizing patient trauma. The cutting action is typically achieved through an end effector, ultrasonic scalpel, or ultrasonic tip at the distal end of the instrument, which transmits ultrasonic energy to the tissue in contact with the end effector. The ultrasonic end effector may include an ultrasonic scalpel, clamping arms, pads, and other components.

[0005] Some surgical instruments use ultrasonic energy for both precise cutting and controlled coagulation. Ultrasonic energy is used to cut and coagulate by vibrating a blade in contact with the tissue. Through high-frequency vibrations (e.g., 55,500 times per second), the ultrasonic blade denatures proteins in the tissue to form a viscous coagulate. The pressure applied to the tissue by the blade surface causes blood vessels to collapse and allows the coagulate to form a hemostatic seal. The precision of the cutting and coagulation depends on the surgeon's skill and the control over the power level, blade edge, tissue traction, and blade pressure.

[0006] Electrosurgical instruments for applying electrical energy modes to tissue to treat, seal, cut, and / or destroy tissue are increasingly used in surgical procedures. Electrosurgical instruments typically include an end effector mounted distally, which comprises one or more electrodes. The end effector is positioned against the tissue so that current is introduced into the tissue. Electrosurgical instruments can be configured for bipolar or monopolar operation. During bipolar operation, current is introduced into the tissue through a first electrode (e.g., an active electrode) and returned from the tissue through a second electrode (e.g., a return electrode). During monopolar operation, current is introduced into the tissue through the active electrode of the end effector and returned through a return electrode, such as a grounding pad, connected separately to the patient's body. The heat generated by the current flowing through the tissue can create a hemostatic seal within and / or between tissues, and is therefore particularly suitable for, for example, sealing blood vessels. The end effector of the electrosurgical instrument may also include a cutting member movable relative to the tissue and electrodes to tranverse the tissue. Electrosurgical end effectors can be adapted and configured to be coupled to handheld instruments as well as robotic instruments.

[0007] Electrical energy applied by an electrosurgical instrument can be transmitted to the instrument via a generator connected to a handheld device. The electrical energy can be in the form of radio frequency (“RF”) energy. RF energy is electrical energy that can be in the frequency range of 200 kHz to 1 MHz. In application, the electrosurgical instrument transmits low-frequency RF energy through the tissue, which causes ion oscillations or friction, effectively resulting in resistive heating and thus raising the temperature of the tissue. Because a clear boundary is formed between the affected tissue and the surrounding tissue, the surgeon can operate with high precision and control without damaging adjacent non-target tissue. The low operating temperature of RF energy is suitable for removing, shrinking, or shaping soft tissue while sealing blood vessels. RF energy is particularly effective for connective tissue, which is primarily composed of collagen and shrinks upon contact with heat.

[0008] RF energy can be within the frequency range described in EN 60601-2-2:2009+A11:2011, definition 201.3.218 - High Frequency. For example, frequencies in monopolar RF applications are typically limited to less than 5 MHz. However, in bipolar RF energy applications, the frequency can be almost any value. Monopolar applications typically use frequencies above 200 kHz to avoid undesirable nerve and muscle stimulation due to the use of low-frequency current. Bipolar applications can use lower frequencies if a risk analysis shows that the possibility of neuromuscular stimulation has been mitigated to an acceptable level. Generally, frequencies above 5 MHz are not used to minimize the problems associated with high-frequency leakage current. However, higher frequencies can be used in the case of bipolar applications. 10 mA is generally considered to be the lower limit threshold for tissue thermal effects.

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

[0010] A challenge with these surgical instruments is the inability to control and customize single or multiple energy modes based on the type of tissue being treated. There is a desire to provide end effectors that overcome some of the limitations of current surgical instruments and improve the quality of tissue treatment, sealing or cutting, or combinations of these operations. The combined energy mode end effector described herein overcomes these limitations and improves the quality of tissue treatment, sealing or cutting, or combinations of these operations. Summary of the Invention

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

[0012] In various aspects, this disclosure provides a surgical instrument configured to deliver at least two types of energy (e.g., ultrasound, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue. The surgical instrument includes a first activation button for activating the energy and a second button for selecting an energy mode for the activation button. The second button is connected to circuitry that defines the energy mode using at least one input parameter. The input parameter can be modified remotely via a connection to a generator or via a software update.

[0013] In one aspect, this disclosure provides a combined ultrasound / bipolar RF energy surgical device. The combined ultrasound / bipolar RF energy surgical device includes an end effector. The end effector includes a clamping arm and an ultrasonic scalpel. The clamping arm includes a movable clamp, a flexible polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to the positive terminal of an RF generator, and the ultrasonic scalpel is coupled to the negative terminal of the RF generator. The ultrasonic scalpel is acoustically coupled to an ultrasonic transducer stack driven by an ultrasound generator. In one aspect, the at least one electrode serves as a deflectable support relative to an opposing ultrasonic scalpel. The at least one electrode passes through the ultrasonic scalpel and is configured to be deflectable relative to the clamping arm, which has features that alter the mechanical properties of tissue compression beneath the at least one electrode. The at least one electrode includes features that prevent accidental contact between the electrode and the ultrasonic scalpel.

[0014] In another aspect, this disclosure provides a combined ultrasound / bipolar RF energy surgical device. This combined ultrasound / bipolar RF energy surgical device includes an end effector. The end effector includes a clamping arm and an ultrasonic scalpel. The clamping arm includes a movable clamp, a flexible polymer pad, and at least one bipolar RF electrode. At least one electrode is coupled to the positive terminal of an RF generator, and the ultrasonic scalpel is coupled to the negative terminal of the RF generator. The ultrasonic scalpel is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, the movable clamp includes at least one non-biased deflectable electrode to minimize contact between the ultrasonic scalpel and the RF electrode. The ultrasonic scalpel pad includes features for securing the electrode to the pad. As the pad wears down or is cut through, the height of the electrode relative to the clamp is adjusted progressively. Once the clamp is removed from the ultrasonic scalpel, the electrode remains in its new position.

[0015] In another aspect, this disclosure provides a combined ultrasound / bipolar RF energy surgical device. This combined ultrasound / bipolar RF energy surgical device includes an end effector. The end effector includes a clamping arm and an ultrasonic scalpel. The clamping arm includes a movable clamp, a flexible polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to the positive terminal of an RF generator, and the ultrasonic scalpel is coupled to the negative terminal of the RF generator. The ultrasonic scalpel is acoustically coupled to an ultrasonic transducer stack driven by the ultrasound generator. In one aspect, the at least one bipolar RF electrode is deflectable and has a greater distal bias than a proximal bias. The bipolar RF electrode is capable of deflection relative to the clamp. The end effector is configured to alter the mechanical properties of tissue compression from the proximal end to the distal end to produce a more uniform or different pressure pattern than that produced by clamping alone.

[0016] In another aspect, this disclosure provides a combined ultrasound / bipolar RF energy surgical device. This combined ultrasound / bipolar RF energy surgical device includes an end effector. The end effector includes a clamping arm and an ultrasonic scalpel. The clamping arm includes a movable clamp, a flexible polymer pad, and at least one bipolar RF electrode. At least one electrode is coupled to the positive terminal of an RF generator, and the ultrasonic scalpel is coupled to the negative terminal of the RF generator. The ultrasonic scalpel is acoustically coupled to an ultrasonic transducer stack driven by the ultrasound 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 be able to change the mechanical properties of tissue compression beneath the electrode based on clamp closure or clamping amount.

[0017] In another aspect, this disclosure provides a combined ultrasound / bipolar RF energy surgical device. This combined ultrasound / bipolar RF energy surgical device includes an end effector. The end effector includes a clamping arm and an ultrasonic scalpel. The clamping arm includes a movable clamp, a flexible polymer pad, and at least one bipolar RF electrode. At least one electrode is coupled to the positive terminal of an RF generator, and the ultrasonic scalpel is coupled to the negative terminal of the RF generator. The ultrasonic scalpel is acoustically coupled to an ultrasonic transducer stack driven by the ultrasonic generator. In one aspect, the pad includes asymmetrical segments to provide support for the ultrasonic scalpel support, and the electrode is movable. The asymmetrical segmented pad is configured to cooperate 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 significantly higher than a second pad element. A first pad element extends entirely through the bipolar RF electrode, and a second pad element extends partially through the bipolar RF electrode. The first and second pad elements are made of different materials.

[0018] In another aspect, this disclosure provides a combined ultrasound / bipolar RF energy surgical device. This combined ultrasound / bipolar RF energy surgical device includes an end effector. The end effector includes a clamping arm and an ultrasonic scalpel. The clamping arm includes a movable clamp, a flexible polymer pad, and at least one bipolar RF electrode. At least one electrode is coupled to the positive terminal of an RF generator, and the ultrasonic scalpel is coupled to the negative terminal of the RF generator. The ultrasonic scalpel is acoustically coupled to an ultrasonic transducer stack driven by an ultrasound generator. In one aspect, variations in the physical parameters of the electrodes are used in conjunction with deflectable electrodes to alter the energy density delivered to the tissue and tissue interaction. The physical aspects of the electrodes vary along their length to change the contact area and / or energy density between the electrodes and the tissue as the electrodes are also deflected.

[0019] In another aspect, this disclosure provides a combined ultrasound / bipolar RF energy surgical device. This combined ultrasound / bipolar RF energy surgical device includes an end effector. The end effector includes a clamping arm and an ultrasonic scalpel. The clamping arm includes a movable clamp, a flexible polymer pad, and at least one bipolar RF electrode. At least one electrode is coupled to the positive terminal of an RF generator, and the ultrasonic scalpel is coupled to the negative terminal of the RF generator. The ultrasonic scalpel is acoustically coupled to an ultrasonic transducer stack driven by the ultrasound generator. In one aspect, an ultrasonic transducer control algorithm is provided to reduce the power delivered by the ultrasound or RF generator when a short circuit is detected between the ultrasonic scalpel and the electrode, thereby preventing damage to the ultrasonic scalpel. The ultrasonic scalpel control algorithm monitors for electrical short circuits or contact between the ultrasonic scalpel and the electrode. This detection is used to adjust the power / amplitude level of the ultrasonic transducer when a minimum electrical threshold is exceeded, and to adjust the transducer power / amplitude threshold to a level below a minimum threshold that could potentially damage the ultrasonic scalpel, the ultrasound generator, the bipolar RF electrode, or the bipolar RF generator. The monitored electrical parameter may be tissue impedance (Z) or electrical continuity. Power regulation can be for cutting off the ultrasound generator of a surgical device, a bipolar RF generator, or it can be a proportional response to electrical parameters, pressure, or time, or any combination of these parameters.

[0020] In another aspect, this disclosure provides a combined ultrasound / bipolar RF energy surgical device. This combined ultrasound / bipolar RF energy surgical device includes an end effector. The end effector includes a clamping arm and an ultrasonic scalpel. The clamping arm includes a movable clamp, a flexible polymer pad, and at least one bipolar RF electrode. At least one electrode is coupled to the positive terminal of an RF generator, and the ultrasonic scalpel is coupled to the negative terminal of the RF generator. The ultrasonic scalpel is acoustically coupled to an ultrasonic transducer stack driven by an ultrasound generator. In one aspect, clamping features or aspects are provided in the clamping arm to minimize tissue adhesion and improve tissue control. The tissue path or clamping region of the clamping arm includes features configured to adjust the tissue path relative to the clamping arm / ultrasonic scalpel to form a predetermined contact position thereby reducing tissue adhesion and charring.

[0021] In another aspect, this disclosure provides a combined ultrasound / bipolar RF energy surgical device. This combined ultrasound / bipolar RF energy surgical device includes an end effector. The end effector includes a clamping arm and an ultrasonic scalpel. The clamping arm includes a movable clamp, a flexible polymer pad, and at least one bipolar RF electrode. At least one electrode is coupled to the positive terminal of an RF generator, and the ultrasonic scalpel is coupled to the negative terminal of the RF generator. The ultrasonic scalpel is acoustically coupled to an ultrasonic transducer stack driven by the ultrasound generator. In one aspect, a partially conductive clamping arm pad is provided to allow the electrode to wear through and minimize electrical short circuits between the ultrasonic scalpel and the bipolar RF electrode. The clamping arm pad includes conductive and non-conductive portions, thereby acting as one of the bipolar RF electrodes while also serving as a wear-resistant support structure for the ultrasonic scalpel. The conductive portion of the clamping arm pad is positioned around the periphery of the pad and not directly below the ultrasonic scalpel contact area. The conductive portion is configured to degrade or wear through to prevent any contact with the ultrasonic scalpel from interrupting the conductivity of the remaining conductive pad.

[0022] In addition to the foregoing, various other methods and / or systems and / or program products are listed and described in the teachings such as the text of this disclosure (e.g., the claims and / or detailed embodiments) and / or the drawings.

[0023] The foregoing is an overview and may therefore include simplifications, generalizations, omissions of included parts and / or details; therefore, those skilled in the art will understand that this overview is merely illustrative and not intended to be limiting in any way. Other aspects, features, and advantages of the apparatus and / or processes and / or other subjects described herein will become apparent from the teachings set forth herein.

[0024] In one or more aspects, the relevant system includes, but is not limited to, circuitry and / or programming for performing the methods referenced herein; the circuitry and / or programming can be any combination of hardware, software, and / or firmware configured to influence the methods referenced herein based on 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 such as the text of this disclosure (e.g., the claims and / or detailed embodiments) and / or the accompanying drawings.

[0025] Furthermore, it should be understood that any one or more of the following forms, formal expressions, and examples may be combined with any one or more of the other forms, formal expressions, and examples described below.

[0026] The above-described invention is merely illustrative and not intended to be limiting in any way. Other aspects, embodiments, and features will become apparent from the accompanying drawings and the detailed description below, in addition to the illustrative aspects, embodiments, and features described above. Attached Figure Description

[0027] The novel features of this form are specifically set forth in the appended claims. However, the form relating to the organization and method of operation is best understood by referring to the following description in conjunction with the accompanying drawings, wherein:

[0028] Figure 1 This is a perspective view of the clamping arm portion of an end effector used with a combined ultrasonic / RF device according to at least one aspect of this disclosure.

[0029] Figure 2 It is based on at least one aspect of this disclosure Figure 1 An exploded view of the clamping arm is shown.

[0030] Figure 3 and Figure 4 It is a perspective view of the framework according to at least one aspect of this disclosure.

[0031] Figure 5 This is a perspective view of an electrode according to at least one aspect of this disclosure.

[0032] Figure 6 This is a perspective view of the clamping arm pad according to at least one aspect of this disclosure.

[0033] Figure 7 It is a perspective top view of a large gap pad according to at least one aspect of this disclosure.

[0034] Figure 8 It is a perspective top view of a small gap pad according to at least one aspect of this disclosure.

[0035] Figure 9 yes Figure 8 The bottom perspective view of the small gap pad shown.

[0036] Figures 10 to 12 An actuator comprising a shortened gripping arm suitable for deflectable / cantilever electrode applications is shown according to various aspects of this disclosure, wherein:

[0037] Figure 10 This is a side view of an end effector comprising a shortened clamping arm, an ultrasonic scalpel, an electrode, and a clamping arm pad, according to at least one aspect of this disclosure;

[0038] Figure 11 This is a top view of an end effector according to at least one aspect of this disclosure; and

[0039] Figure 12 A clamping arm comprising a clamp, an electrode, and a clamping arm pad is shown according to at least one aspect of the present disclosure.

[0040] Figure 13An end effector clamping arm comprising a clamp, an electrode, and a clamping arm pad is shown according to at least one aspect of the present disclosure.

[0041] Figure 14 An end effector clamping arm comprising a clamp, an electrode, and a clamping arm pad is shown according to at least one aspect of the present disclosure.

[0042] Figure 15 An end effector clamping arm comprising a clamp, an electrode, and a clamping arm pad is shown according to at least one aspect of the present disclosure.

[0043] Figure 16 The diagram shows worn bottom retainer teeth according to at least one aspect of the present disclosure, such that the electrode can be moved toward the clamp due to the pre-shaped curve.

[0044] Figure 17 An end effector clamping arm comprising a clamp, an electrode, and a clamping arm pad is shown according to at least one aspect of the present disclosure.

[0045] Figure 18 A retainer wall with a worn-out tapered profile is shown according to at least one aspect of the present disclosure, such that there is sufficient melting / flow away from the retainer wall with the tapered profile region to allow the electrode to move toward the clamp due to the pre-formed curve.

[0046] Figures 19 to 21 An end effector according to at least one aspect of the present disclosure is shown, the end effector comprising a clamping arm, an ultrasonic scalpel, a mesh pad, a flexible electrode disposed above the mesh pad, and a plurality of rigid spacers for defining a gap between the flexible electrode and the ultrasonic scalpel, wherein:

[0047] Figure 19 This shows tissue with open clamping arms and uneven thickness (T). 1a T 2a T 3a It is positioned above the flexible electrode;

[0048] Figure 20 The clamping arms are shown closing to compress the tissue; and

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

[0050] Figure 22 This is a cross-sectional view of a conductive polymer clamping arm pad according to at least one aspect of this disclosure.

[0051] Figure 23 This is a perspective view of a clamping arm pad configured to replace a conventional electrode according to at least one aspect of this disclosure.

[0052] Figure 24 The present disclosure illustrates at least one aspect including Figure 23 The clamping arm of the clamping arm pad.

[0053] Figure 25 At least one aspect of this disclosure is shown as follows Figures 23 to 24 The clamping arm pad with the structure described herein.

[0054] Figure 26 This is a cross-sectional view of a clamping arm including a composite material clamping arm pad that contacts tissue, according to at least one aspect of this disclosure.

[0055] Figure 27 A clamping arm according to at least one aspect of the present disclosure is shown, the clamping arm including clamps for supporting a bracket or stamping attached to a clamp and a clamping arm pad.

[0056] Figure 28 It is along Figure 27 The sectional view taken from section 28-28.

[0057] Figure 29 It is along Figure 27 The sectional view taken from section 29-29.

[0058] Figure 30 This is a cross-sectional view of an alternative embodiment of a clamping arm comprising a clamp, a conductive pad, and a non-conductive pad, according to at least one aspect of this disclosure.

[0059] Figure 31 This is a cross-sectional view of an alternative embodiment of a clamping arm comprising a clamp, a bracket or stamping welded to the clamp, a conductive pad, and a non-conductive pad, according to at least one aspect of this disclosure.

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

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

[0062] Figure 34 It shows Figure 33 The clamping arm shown.

[0063] Figure 35 It is along Figure 34 The sectional view of the clamping arm taken from section 35-35.

[0064] Figure 36 A clamping arm comprising a partially conductive clamping arm pad is shown according to at least one aspect of the present disclosure.

[0065] Figures 37 to 39 A clamping arm according to at least one aspect of the present disclosure is shown, the clamping arm comprising an I-beam shaped clamping arm pad configured for use with an end effector including clamps, an ultrasonic scalpel (not shown), and electrodes, wherein:

[0066] Figure 38 This is a top view of the clamping arm, showing the clamping arm pad as viewed from above the electrodes; and

[0067] Figure 39 This is a top view of the electrode, showing the longitudinal groove in which the clamping arm pad is slidably received.

[0068] Figures 40A to 40C Assembly according to at least one aspect of this disclosure is shown. Figures 37 to 39 The method of clamping arm shown, wherein:

[0069] Figure 40A The electrode is shown welded to the proximal end of the clamp at the welding point;

[0070] Figure 40B A clamping arm pad that can be slidably inserted into a longitudinal slot is shown; and

[0071] Figure 40C A hard, wear-resistant gap setting pad for setting the gap is shown, which can be slidably inserted into the clamp.

[0072] Figures 41 to 43 An end effector according to at least one aspect of the present disclosure is shown, the end effector providing a recess at a location within the electrode where it overlaps with the ultrasonic scalpel to minimize impact between the ultrasonic scalpel and the electrode, wherein:

[0073] Figure 41 This is a cross-sectional view of an end effector comprising a clamping arm, an ultrasonic scalpel, an electrode, and a heavy polymer support pad, according to at least one aspect of this disclosure;

[0074] Figure 42 This is a cross-sectional view of the end effector, showing wear on the polymer support pad and tissue clamped between the clamping arm and the ultrasonic scalpel; and

[0075] Figure 43 This is a magnified view of the end effector.

[0076] Figures 44 to 45 A clamping arm according to at least one aspect of the present disclosure is shown, the clamping arm comprising clamps and a stationary gap setting pad combined with a movable floating gap setting pad, wherein:

[0077] Figure 44 This is a top view of the clamping arm, showing the stationary clearance setting pad and the movable floating clearance setting pad; and

[0078] Figure 45 This is a side view of the clamping arm, showing the clamp, stationary gap setting pad, movable floating gap setting pad, electrode, and clamping arm pad.

[0079] Figure 46 An alternative clamping arm according to at least one aspect of the present disclosure is shown, the clamping arm including a clamp, a stationary clearance setting pad at a distal end, a stationary clamping arm pad, and a movable floating clearance setting pad at a proximal end.

[0080] Figure 47 An alternative clamping arm according to at least one aspect of the present disclosure is shown, the clamping arm including a clamp, a stationary clearance setting pad at a distal end, a stationary clamping arm pad, and a movable floating clearance setting pad at a proximal end.

[0081] Figures 48 to 49 A combined ultrasound / bipolar RF energy surgical device employing electrodes including small teeth, according to at least one aspect of this disclosure, is shown, wherein:

[0082] Figure 48 An end effector according to at least one aspect of this disclosure is shown, comprising a clamping arm, an ultrasonic scalpel, an electrode including multiple teeth, a flexible clamping arm pad, and a hard gap setting pad; and

[0083] Figure 49 An end effector comprising a clamping arm, an ultrasonic scalpel, an electrode, a flexible clamping arm pad, and a hard gap setting pad, according to at least one aspect of the present disclosure, is shown.

[0084] Figures 50 to 57 A clamping arm according to at least one aspect of the present disclosure is shown, the clamping arm comprising a reloadable electrode coupled with a clamping arm pad including teeth, wherein:

[0085] Figure 50 A reloadable electrode and clamping arm pad according to at least one aspect of this disclosure are shown;

[0086] Figure 51 A clamping arm is shown, including a reloadable electrode and a clamping arm pad located within the clamp;

[0087] Figure 52 This is a side view of the reloadable electrode and clamping arm pad that are slidably inserted into the clamp from the front.

[0088] Figure 53 This is a top view of the reloadable electrode and clamping arm pad that are slidably inserted into the clamp from the front.

[0089] Figure 54It is a cross-sectional view of the electrode support leg inserted into the clamp recess and the curved tab located in the groove of the clamp;

[0090] Figure 55 This is a detailed view of the recess in the clamping arm;

[0091] Figure 56 This demonstrates how to release the arm by pressing the bending tab; and

[0092] Figure 57 This is a detailed view of a reloadable electrode and arm as a stamping component, showing an extension of the metal sheet and orifices for receiving teeth of a clamping arm pad, orifices for receiving a hard wear-resistant gap pad, and orifices for receiving a hard wear-resistant gap pad.

[0093] Figures 58 to 60 An end effector comprising an ultrasonic scalpel and a clamping arm according to at least one aspect of the present disclosure is shown, the clamping arm comprising a spring-loaded clamping arm pad, wherein:

[0094] Figure 58 This is a perspective view of the end effector;

[0095] Figure 59 This is a cross-sectional view of the end effector; and

[0096] Figure 60 This is an exploded view of the end effector.

[0097] Figure 61 A spring-loaded clamping arm pad according to at least one aspect of the present disclosure is shown.

[0098] Figure 62 A clamping arm comprising a spring-loaded clamping arm pad is shown according to at least one aspect of the present disclosure.

[0099] Figure 63 A clamping arm comprising a spring-loaded clamping arm pad, an electrode, and a gap setting pad is shown according to at least one aspect of the present disclosure.

[0100] Figure 64 A clamping arm comprising a spring-loaded clamping arm pad uniformly raised by an elastomeric spring, according to at least one aspect of the present disclosure, is shown.

[0101] Figure 65 A clamping arm comprising a spring-loaded clamping arm pad is shown according to at least one aspect of the present disclosure.

[0102] Figures 66 to 82 An end effector according to at least one aspect of the present disclosure is shown, the end effector comprising a first configuration and a second configuration of a floating gripping arm combined with an ultrasonic scalpel, wherein:

[0103] Figure 66 Two configurations of the end effector are shown;

[0104] Figure 67 This is an exploded view of the clamp, electrode, and ultrasonic scalpel components, which are common to either the first or second configuration of the floating clamping arm.

[0105] Figure 68 The clamping arm pad unit and the one-piece elastic / hyperelastic block component of the first configuration of the floating clamping arm are shown;

[0106] Figure 69 The second configuration of the floating clamping arm is shown, including the clamping arm pad unit and the multi-piece elastic / hyperelastic block component.

[0107] Figure 70 The arrangement of clamping arm pad units, which protrude through orifices formed in the electrodes but do not contact each other, is shown according to at least one aspect of the present disclosure.

[0108] Figure 71 The aperture, defined by the electrodes, is shown to be configured to receive any of the clamping arm pad units;

[0109] Figure 72 It is an assembly diagram of the first configuration clamping arm, which includes a single-piece elastic / hyperelastic block;

[0110] Figure 73 This is a cross-sectional view of a first configuration of an end effector including a floating clamping arm and an ultrasonic scalpel according to at least one aspect of this disclosure.

[0111] Figure 74 This is a cross-sectional view of a second configuration of an end effector including a floating clamping arm and an ultrasonic scalpel according to at least one aspect of this disclosure.

[0112] Figure 75 A method for assembling a first-configuration end effector comprising a floating gripping arm and an ultrasonic scalpel according to at least one aspect of this disclosure is shown.

[0113] Figure 76 It shows that according to Figure 75 Assembled end effectors;

[0114] Figure 77 A single-piece elastic / hyperelastic block is shown being pushed into compression;

[0115] Figure 78 The location where the pressure between the ultrasonic scalpel and a single clamping arm pad unit can be balanced by a one-piece elastic / hyperelastic block is shown.

[0116] Figure 79A method for assembling a second-configuration end effector comprising a floating gripping arm and an ultrasonic scalpel according to at least one aspect of this disclosure is shown;

[0117] Figure 80 It shows that according to Figure 79 Assembled end effectors;

[0118] Figure 81 This demonstrates how, at locations with higher tissue volume, multi-piece elastic / hyperelastic blocks are pushed into compression by individual clamping arm pad units; and

[0119] Figure 82 The position where the pressure between the ultrasonic scalpel and a single clamping arm pad unit can be balanced by a multi-piece elastic / hyperelastic block is shown.

[0120] Figure 83 A clamping arm comprising selectively deployable pad teeth is shown according to at least one aspect of the present disclosure.

[0121] Figure 84 It is based on at least one aspect of this disclosure Figure 83 The shown is a cross-sectional view of a clamping arm, which includes selectively deployable pad teeth positioned in a retracted configuration within an orifice.

[0122] Figure 85 It is based on at least one aspect of this disclosure Figure 83 The shown is a cross-sectional view of a clamping arm, which includes selectively deployable pad teeth in an deployed configuration.

[0123] Figure 86 It is based on at least one aspect of this disclosure Figure 83 The detailed cross-sectional view shown includes a clamping arm with selectively deployable pad teeth in a retracted configuration.

[0124] Figure 87A The illustration shows that at least one aspect of the present disclosure is configured to accept such Figures 87B to 87C The end actuator of the heat dissipation material block shown.

[0125] Figure 87B It shows Figure 87A An example of an end effector is shown, in which a block of heat-dissipating material is added to or otherwise fixedly attached to a clamping arm pad supported by metal clamps.

[0126] Figure 87C A block of heat-dissipating material with worn clamping arm pads is shown.

[0127] Figure 88A An end effector comprising a metal clamp and an ultrasonic scalpel according to at least one aspect of the present disclosure is shown, wherein at least some portions of the metal clamp are made of a heat-dissipating material.

[0128] Figure 88B An alternative clamping arm pad is shown.

[0129] Figure 88C A heat dissipation material is shown, comprising one or both of materials having high thermal conductivity and high specific heat, and forming a large surface area feature to enhance heat diffusion as heat accumulates in the clamping arm pad.

[0130] Figure 89 It shows Figures 87A to 87C and 88A to Figure 88C The components of the end effector described herein.

[0131] Figure 90 A heat dissipation structure comprising fins for increasing the surface area of ​​a heat sink component is shown according to at least one aspect of the present disclosure.

[0132] Figure 91 Another heat dissipation structure according to at least one aspect of the present disclosure is shown, which includes holes for increasing the surface area of ​​the heat sink component.

[0133] Figure 92 A surgical device according to at least one aspect of the present disclosure is shown, the surgical device including a mode selection button switch on the device.

[0134] Figures 93A to 93C Three options for selecting various operating modes of the surgical device according to at least one aspect of this disclosure are shown, wherein:

[0135] Figure 93A The first mode selection option is shown, where a button switch can be pressed forward or backward to cycle the surgical instruments between various modes;

[0136] Figure 93B A second mode selection option is shown, in which pressing the button switch up or down cycles the surgical instruments between various modes; and

[0137] Figure 93C A third mode selection option is shown, where pressing the button switch forward, backward, up, or down cycles the surgical instruments between various modes.

[0138] Figure 94 A surgical device according to at least one aspect of the present disclosure is shown, the surgical device including a mode selection button switch on the back of the device.

[0139] Figure 95A The first mode selection option is shown, where colored light indicates the selected mode on the user interface as the mode button switch is pressed to switch between various modes.

[0140] Figure 95B A 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.

[0141] Figure 95C 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.

[0142] Figure 95D 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.

[0143] Figure 96 A surgical device including a trigger activation mechanism is shown according to at least one aspect of the present disclosure.

[0144] Figure 97 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.

[0145] Figure 98 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 instrument.

[0146] Figure 99 An example of a generator according to at least one aspect of this disclosure is shown.

[0147] Figure 100 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.

[0148] Figure 101A 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.

[0149] Figure 101B It is installed on the cart according to at least one aspect of this disclosure. Figure 101A The modular energy system shown.

[0150] Figure 102 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.

[0151] Figure 103At least one aspect of this disclosure is shown. Figure 102 A top perspective view of the end effector of a surgical instrument, the end effector having a clamping arm providing a first electrode and an ultrasonic scalpel providing a second electrode.

[0152] Figure 104 At least one aspect of this disclosure is shown. Figure 103 Bottom perspective view of the end effector.

[0153] Figure 105 At least one aspect of this disclosure is shown. Figure 102 A partial exploded perspective view of a surgical instrument.

[0154] Figure 106 At least one aspect of this disclosure is shown. Figure 102 An enlarged exploded perspective view of the distal portion of the shaft assembly and the end effector of a surgical instrument. Detailed Implementation

[0155] The applicant of this patent application owns the following U.S. provisional patent applications filed on December 30, 2019, the entire disclosure of each of which is incorporated herein by reference:

[0156] • U.S. Provisional Patent Application Serial No. 62 / 955,294, entitled "USER INTERFACE FOR SURGICALINSTRUMENT WITH COMBINATION ENERGY MODALITY END-EFFECTOR";

[0157] • U.S. Provisional Patent Application Serial No. 62 / 955,299, entitled ELECTROSURGICAL INSTRUMENTSFOR COMBINATION ENERGY DELIVERY; and

[0158] • U.S. Provisional Patent Application Serial No. 62 / 955,306, entitled SURGICAL INSTRUMENTS.

[0159] The applicant of this application owns the following U.S. patent applications filed on the same date as this application, each of which is incorporated herein by reference in its entirety:

[0160] • The agent's case file number is END9232USNP1 / 190715-1, and the title is USER INTERFACE FOR SURGICALINSTRUMENT WITH COMBINATION ENERGY MODALITY END-EFFECTOR;

[0161] • The agent's case file number is END9233USNP1 / 190716-1M, and the title is METHOD OF OPERATING ACOMBINATION ULTRASONIC / BIPOLAR RF SURGICAL DEVICE WITH A COMBINATION ENERGYMODALITY END-EFFECTOR;

[0162] • The agent's case file number is END9233USNP2 / 190716-2, and the title is DEFLECTABLE SUPPORT OF RFENERGY ELECTRODE WITH RESPECT TO OPPOSING ULTRASONIC BLADE;

[0163] • The agent's case file number is END9233USNP3 / 190716-3, and the title is Non-Biseted Deficient Electrode to Minimize Contact Between Ultrasonic Blade and Electrode;

[0164] • The agent's case file number is END9233USNP4 / 190716-4, and the title is DEFLECTABLE ELECTRODE WITHHIGHER DISTAL BIAS RELATIVE TO PROXIMAL BIAS;

[0165] • The agent's case file number is END9233USNP5 / 190716-5, and the title is DEFLECTABLE ELECTRODE WITH VARIABLE COMPRESSION BIAS ALONG THE LENGTH OF THE DEFLECTABLE ELECTRODE;

[0166] • The agent's case file number is END9233USNP7 / 190716-7, and the title is VARIATION IN ELECTRODE PARAMETERS AND DEFLECTABLE ELECTRODE TO MODIFY ENERGY DENSITY AND TISSUE INTERACTION;

[0167] • The agent's case file number is END9233USNP8 / 190716-8, and the title is TECHNIQUES FOR DETECTING ULTRASONIC BLADE TO ELECTRODE CONTACT AND REDUCING POWER TO ULTRASONIC BLADE;

[0168] • The agent's case file number is END9233USNP9 / 190716-9, titled "CLAMP ARM JAW TO MINIMIZETISSUE STICKING AND IMPROVE TISSUE CONTROL"; and

[0169] • The agent's case file number is END9233USNP10 / 190716-10, and the title is PARTIALLY CONDUCTIVECLAMP ARM PAD TO ENABLE ELECTRODE WEAR THROUGH AND MINIMIZE SHORT CIRCUITING.

[0170] The applicant of this application owns the following U.S. patent applications filed on May 28, 2020, each of which is incorporated herein by reference in its entirety:

[0171] • U.S. Patent Application Serial No. 16 / 885,813, entitled METHOD FOR AN ELECTROSURGICAL PROCEDURE;

[0172] • U.S. Patent Application Serial No. 16 / 885,820, entitled Artificial Surgicalinstrument;

[0173] • U.S. Patent Application Serial No. 16 / 885,823, entitled SURGICAL INSTRUMENT WITH JAWALIGNMENT FEATURES;

[0174] • U.S. Patent Application Serial No. 16 / 885,826, entitled SURGICAL INSTRUMENT WITHROTATABLE AND ARTICULATABLE SURGICAL END EFFECTOR;

[0175] • U.S. Patent Application Serial No. 16 / 885,838, entitled "ELECTROSURGICAL INSTRUMENT WITHASYNCHRONOUS ENERGIZING ELECTRODES";

[0176] • U.S. Patent Application Serial No. 16 / 885,851, entitled "Electrosurgical Instrument with Electrodes Biasing Support";

[0177] • U.S. Patent Application Serial No. 16 / 885,860, entitled "Electrosurgical Instruction with Fluxble Wiring Assemblies";

[0178] • U.S. Patent Application Serial No. 16 / 885,866, entitled "Electrosurgical Instrument with Valiable Control Mechanisms";

[0179] • US Patent Application Serial No. 16 / 885,870, entitled ELECTROSURGICAL SYSTEMS WITHINTEGRATED AND EXTERNAL POWER SOURCES;

[0180] • U.S. Patent Application Serial No. 16 / 885,873, entitled "ELECTROSURGICAL INSTRUMENTS WITH ELECTRODES HAVING ENERGY FOCUSING FEATURES";

[0181] • U.S. Patent Application Serial No. 16 / 885,879, entitled "ELECTROSURGICAL INSTRUMENTS WITHELECTRODES HAVING VARIABLE ENERGY DENSITIES";

[0182] • U.S. Patent Application Serial No. 16 / 885,881, entitled "ELECTROSURGICAL INSTRUMENT WITH MONOPOLARA AND BIPOLAR ENERGY CAPABILITIES";

[0183] • U.S. Patent Application Serial No. 16 / 885,888, entitled "ELECTROSURGICAL END EFFECTORS WITH THERMALLY INSULATIVE AND THERMALLY CONDUCTIVE PORTIONS";

[0184] • U.S. Patent Application Serial No. 16 / 885,893, entitled "Electrosurgical Instruction with Electrodes Operable in Biblolar and Monopolar Modes";

[0185] • U.S. Patent Application Serial No. 16 / 885,900, entitled "ELECTROSURGICAL INSTRUMENT FOR DELIVERING BLENDED ENERGY MODALITIES TO TISSUE";

[0186] • US Patent Application Serial No. 16 / 885,917, entitled "CONTROL PROGRAM ADAPTATION BASEDON DEVICE STATUS AND USER INPUT";

[0187] • U.S. Patent Application Serial No. 16 / 885,923, entitled "CONTROL PROGRAM FOR MODULARCOMBINATION ENERGY DEVICE"; and

[0188] • U.S. Patent Application Serial No. 16 / 885,931, entitled SURGICAL SYSTEM COMMUNICATION PATHWAYS.

[0189] Before detailing the various forms of surgical instruments, it should be noted that the application or use of the exemplary forms is not limited to the details of the construction and arrangement of the components shown in the accompanying drawings and detailed embodiments. The exemplary forms can be implemented alone or in combination with other forms, variations, and modifications, and can be practiced or performed in a variety of ways. Furthermore, unless otherwise specified, the terminology and expressions used herein are chosen for the convenience of the reader in describing the exemplary forms and are not intended to be restrictive.

[0190] Furthermore, it should be understood that any one or more of the following forms, formal expressions, and examples may be combined with any one or more of the other forms, formal expressions, and examples described below.

[0191] Various forms involve modified ultrasound and / or electrosurgical (RF) instruments configured to perform tissue treatment, dissection, cutting, and / or coagulation during surgical procedures. In one form, the combined ultrasound and electrosurgical instruments can be configured for open surgical procedures, but are also used in other types of surgical procedures, such as minimally invasive laparoscopic, visual, or thoracic procedures, such as non-invasive endoscopic procedures in handheld or robot-assisted procedures. Versatility is achieved by selectively applying multiple energy modalities simultaneously, independently, sequentially, or in combination. For example, versatility can be achieved by selectively using ultrasound and electrosurgical energy (e.g., monopolar or bipolar RF energy) simultaneously, independently, sequentially, or in combination.

[0192] In one aspect, this disclosure provides an ultrasonic surgical clamping device comprising an ultrasonic scalpel and a deflectable RF electrode, such that the ultrasonic scalpel and the deflectable RF electrode cooperate to perform tissue sealing, cutting, and clamping through a clamping mechanism of the device including the RF electrode in cooperation with the associated ultrasonic scalpel. The clamping mechanism includes a pivoting clamping arm that cooperates with the ultrasonic scalpel to grasp tissue therebetween. The clamping arm preferably has a tissue-holding pad (also referred to as a "clamping arm pad") having a plurality of axially spaced clamping teeth, segments, elements, or individual units that cooperate with the ultrasonic scalpel of the end effector to achieve desired sealing and cutting effects on the tissue, while facilitating tissue grasping and clamping during surgical procedures.

[0193] In one aspect, the end effector described herein includes electrodes. In other aspects, the end effector described herein includes alternative forms of electrodes to provide a flexible connection of RF energy to tissue, accommodate pad wear / thinning, minimize the generation of excessive heat (low coefficient of friction, pressure), minimize spark generation, minimize interruptions due to electrical short circuits, or combinations thereof. The electrodes are secured to the clamp at a proximal end and freely deflect at a distal end. Thus, throughout this disclosure, the electrodes may be referred to as cantilever beam electrodes or deflectable electrodes.

[0194] In other respects, the end effector described herein includes a clamping arm mechanism configured to apply high pressure between the pad and the ultrasonic scalpel to grip and seal tissue, maximizing the likelihood of the clamping arm electrode contacting tissue in confined or difficult scenarios such as, for example, thin tissue, tissue under lateral tension, tissue bulging / vertical tension, especially when bulging tissue is far from the clamping arm.

[0195] In other respects, the end effector described herein is configured to balance the surface area / current density matching between electrodes, balance and minimize thermal conduction from tissue interfaces, such as those affecting damage formation and symmetry, cycle time, and residual heat energy.

[0196] In other respects, the end effector described herein is configured to minimize adhesion, tissue adhesion (minimize anchor points) and may include small polyimide pads.

[0197] In various aspects, this disclosure provides a combined ultrasound / bipolar RF energy surgical device. The combined ultrasound / bipolar RF energy surgical device includes an end effector. The end effector includes a clamping arm and an ultrasonic scalpel. The clamping arm includes a movable clamp, a flexible polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to the positive terminal of an RF generator, and the ultrasonic scalpel is coupled to the negative terminal of the RF generator. The ultrasonic scalpel is acoustically coupled to an ultrasonic transducer stack driven by the ultrasound generator. In various aspects, the end effector includes an electrode biasing mechanism.

[0198] In a general aspect, this disclosure relates to a method of using a surgical device comprising a combination of ultrasound and advanced bipolar RF energy, and a movable RF electrode located on at least one clamp of an end effector. The movable RF electrode has a variable bias force from a proximal end to a distal end. The movable RF electrode is segmented into discrete portions, and therefore can be electrically connected or isolated from each other. The movable RF electrode is made of a conductive or partially conductive material. It should be understood that any end effector described in this disclosure may be configured with an electrode biasing mechanism.

[0199] In one aspect, this disclosure provides a restricted electrode biasing mechanism to prevent damage to the electrodes by an ultrasonic scalpel. Generally, in various aspects, this disclosure provides an end effector for use with an ultrasound / RF combination device, wherein the end effector includes electrodes. In one aspect, the combined ultrasound / bipolar RF energy surgical device includes an electrode biasing mechanism. In one aspect, the restricted electrode biasing mechanism is configured to prevent or minimize damage to the electrodes by an ultrasonic scalpel. The electrodes are secured to a clamp at a proximal end and freely deflect at a distal end. Therefore, throughout this disclosure, the electrodes may be referred to as cantilever electrodes or deflectable electrodes.

[0200] In various aspects, this disclosure provides an electrode cantilever beam fixed only at one end, including a bias threshold mechanism. In one aspect, the deflectable cantilever electrode is configured for use in a combined ultrasound / bipolar RF energy surgical device.

[0201] In one aspect, the combined ultrasound / RF energy surgical device includes an ultrasonic scalpel, a clamping arm, and at least one electrode passing through the ultrasonic scalpel. In another aspect, the electrode is configured to be deflectable relative to the clamping arm and includes multiple features for altering the mechanical properties of tissue under compression between the electrode and the ultrasonic scalpel. In yet another aspect, the electrode includes features to prevent accidental contact between the electrode and the ultrasonic scalpel, thereby preventing or minimizing damage to the electrode from the ultrasonic scalpel.

[0202] In various aspects, the electrode includes a metal spring element attached to the proximal end of the clamp of the end effector. The metal spring element defines an opening for receiving one or more clamping arm pads (also referred to as "tissue pads" or "tissue-holding pads") passing through it and includes an integrated minimum clearance element. This configuration of the electrode provides a method for preventing tissue buildup around the biasing mechanism, which could affect electrode performance. The configuration also minimizes the adhesion between the wear pad and the bias spring, strengthens the connection between the electrode and the clamping arm, minimizes accidental release of the clamping arm pads by attaching the polyimide pad to the electrode, and achieves a balanced match of surface area / current density between the electrodes. The electrode is secured to the clamp at the proximal end and freely deflects at the distal end. Therefore, throughout this disclosure, the electrode is deflectable and may be referred to as a cantilever electrode or a deflectable electrode.

[0203] Figures 1 to 9 An aspect of an end effector according to at least one aspect of the present disclosure is shown, the end effector including a deflectable / cantilever electrode configured for use with a combined ultrasonic / bipolar RF energy device. Figure 1 This is a perspective view of a portion of the clamping arm 1000 of an end effector used with a combined ultrasound / RF device according to at least one aspect of this disclosure. For the sake of brevity and clarity, the ultrasonic scalpel, which serves as another clamping arm of the end effector, is not shown. The end effector is configured such that the ultrasonic scalpel is one pole of a bipolar RF circuit and the clamping arm 1000 is the opposite pole. A consistent RF electrode gap is maintained between the clamping arm 1000 and the ultrasonic scalpel to prevent the ultrasonic scalpel from contacting the electrodes and causing scalpel breakage or short circuit. The tissue to be treated is clamped and compressed between the clamping arm 1000 and the ultrasonic scalpel.

[0204] The clamping 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, and at least one non-conductive clamping arm pad 1010. In one aspect, the small gap pad 1006 and the large gap pad 1008 are configured to set the gap between the electrode 1004 and the ultrasonic scalpel. The clamping arm pad 1010 is configured to grip tissue between the clamping arm 1000 and the ultrasonic scalpel to assist in tissue sealing and cutting. In other aspects, the non-conductive small gap pad and the non-conductive large gap pad are interchangeable. In still other aspects, the non-conductive gap pads differ simply in size, regardless of the relative dimensional differences between the non-conductive gap pads.

[0205] The pivotal movement of the clamping arm 1000 relative to the end effector is achieved by providing at least one (preferably a pair) lever portion 1012 of the frame 1002 of the clamping arm 1000 at its proximal end 1014. The lever portion 1012 is positioned on a corresponding opposite side of the ultrasonic guide and the end effector and is operatively engaged with a drive portion of a reciprocating actuation member. The reciprocating movement of the actuation member relative to the outer tubular sheath and the ultrasonic guide thereby achieves the pivotal movement of the clamping arm 1000 relative to the end effector about a pivot point 1016. The lever portion 1012 may be positioned in, or otherwise suitably mechanically connected to, a pair of openings defined by the drive portion, whereby the reciprocating movement of the actuation member acts via the drive portion and the lever portion 1012 to pivot the clamping arm 1000.

[0206] Figure 2 It is based on at least one aspect of this disclosure Figure 1An exploded view of the clamping arm 1000 is shown. In various aspects, the electrode 1004 is made of a metal spring material attached to the proximal end 1014 of the frame 1002 of the clamping arm 1000, allowing the electrode 1004 to deflect. The metal spring electrode 1004 defines an opening 1018 for receiving elements of the clamping arm pad 1010 passing through it, and additional openings 1020, 1021 for receiving gap pads 1006, 1008 for setting a minimum gap between the electrode 1004 and the ultrasonic scalpel. At least one gap pad 1006 is disposed on the 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 buildup around the biasing mechanism (e.g., a cantilever spring), which could affect the performance of the electrode 1004. This configuration also minimizes wear between the gripping arm pad 1010 and the bias spring electrode 1004, enhances the strength of the connection between the electrode 1004 and the gripping arm, minimizes accidental release of the gripping arm pad 1018 by attaching the gap pads 1006 and 1008 to the electrode 1004, and achieves a balanced match between the surface area and current density of the electrodes. The electrode 1004 is attached to the frame 1002 via two protrusions 1024. Figure 3 and Figure 4 As shown, the electrode protrusion 1024 is attached to the proximal end 1014 of the frame 1002.

[0207] Figure 3 and Figure 4 These are perspective views of a frame 1002 according to at least one aspect of the present disclosure. These figures show a connection surface 1026 on a proximal end 1014 of the frame 1002 for attaching a proximal end of an electrode 1004 to the frame 1002. In one aspect, an electrode protrusion 1024 is welded to the connection surface 1026 of the frame 1002, such that the electrode 1004 operates in a deflectable manner.

[0208] Figure 5 This is a perspective view of an electrode 1004 according to at least one aspect of this disclosure. The figure illustrates bias in the electrode 1004, made of a spring material, as shown by the bending of the electrode 1004 along its longitudinal length. Openings 1018, 1020, and 1021 are for receiving gap pads 1006 and 1008 and clamping arm pad 1010. In one aspect, the electrode 1004 has a thickness “d” of 0.010”, and can be selected within a thickness range, for example, from 0.005” to 0.015”. See also... Figure 8 and Figure 9 The opening 1020 is sized and constructed to receive the protrusion 1036 defined on the bottom portion of the gap pad 1006.

[0209] Figure 6This is a perspective view of a clamping arm pad 1010 according to at least one aspect of the present disclosure. The clamping arm pad 1010 includes a plurality of clamping arm elements 1032 projecting from a main shaft 1030. Throughout the present disclosure, the clamping arm elements 1032 are also referred to as “teeth”. In one aspect, the clamping arm pad 1010 defines an aperture 1028 in a location where a gap pad 1006 is positioned on an electrode 1004. See also... Figure 8 and Figure 9 The orifice 1028 defined by the clamping arm pad 1010 is sized and constructed to receive a protrusion 1036 defined on the bottom portion of the gap pad 1006. In one aspect, the material of the clamping arm pad 1010 is softer than the material of the gap pads 1006 and 1008. In one aspect, the clamping arm pad 1010 is made of a non-stick lubricating material, such as polytetrafluoroethylene (PTFE) or similar tetrafluoroethylene synthetic fluoropolymers. PTFE is a hydrophobic, non-wetting, high-density, and high-temperature resistant multi-purpose material with non-stick properties. In contrast, the gap pads 1006 and 1008 are made of polyimide material, and in one aspect, for example, of a durable, high-performance polyimide-based plastic known under the trade name VESPEL and manufactured by DuPont, or other suitable polyimide, polyimide polymer alloy, or PET (polyethylene terephthalate), PEEK (polyetheretherketone), or PEKK (polyetherketoneketone) polymer alloy. Unless otherwise stated below, the clamping arm pads and gap pads described below are made of the materials described in this paragraph.

[0210] Figure 7 This 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, which is sized and configured to fit within an opening 1021 at the proximal end 1014 of the electrode 1004. Figure 8 This is a perspective top view of the small gap pad 1006 according to at least one aspect of this disclosure. Figure 9 yes Figure 8 The small gap pad 1006 is shown in a perspective bottom view. Figure 8 and Figure 9 As shown, the small gap pad 1006 includes a protrusion 1036 located at the bottom portion, the protrusion being sized and configured to be received within an opening 1020 defined by the electrode 1004 and an aperture 1028 defined by the clamping arm pad 1010. Both the small gap pad 1006 and the large gap pad 1008 are made of polyimide material, and in one aspect, of a durable, high-performance polyimide-based plastic known under 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.

[0211] In one aspect, this disclosure also provides alternative end effector configurations for combined ultrasound and bipolar RF energy devices. This part of the disclosure provides end effector configurations for combined ultrasound and bipolar RF energy devices. In these configurations, the end effector maintains a consistent gap between the RF electrode gap and the ultrasonic scalpel (which serves as one pole of the bipolar RF circuit) and the clamping arm (which serves as the opposite pole of the bipolar RF circuit). In conventional end effector configurations, the electrode gap is set by a soft PTFE clamping arm pad, which may wear down during surgery. When the clamping arm pad wears through, the ultrasonic scalpel may come into contact with the electrodes, leading to scalpel breakage or an electrical short circuit, both of which are undesirable.

[0212] To overcome these and other limitations, aspects of this disclosure employ a combination of a deflectable RF electrode and a clamping arm pad comprising a non-stick, lubricated, flexible (e.g., PTFE) pad fixed to a clamping arm. The RF electrode includes a wear-resistant, non-conductive pad that contacts the blade to set the blade-electrode gap. The flexible clamping arm pad extends through an opening defined by the electrode and responds to clamping forces from the ultrasonic scalpel. As the flexible clamping arm pad wears, the electrode deflects to maintain a constant gap between the blade and the electrode. This configuration provides a consistent gap between the electrode and the ultrasonic scalpel throughout the device's lifespan, preventing short circuits and ultrasonic scalpel breakage that can occur when the ultrasonic scalpel contacts the electrode, and allowing the electrode material to be directly positioned on the side opposite the ultrasonic scalpel for improved sealing. The electrode is fixed to the clamp at a proximal end and freely deflects at a distal end. Therefore, throughout this disclosure, the electrode may be referred to as a cantilever electrode or a deflectable electrode.

[0213] In one aspect, this disclosure provides an asymmetrical fit of the clamping arm / electrode / pad to achieve ultrasonic scalpel-RF electrode interaction. In another aspect, this disclosure provides a shortened clamping arm. Figures 10 to 12 An actuator comprising a shortened clamping arm suitable for deflectable / cantilevered electrode applications is shown according to various aspects of this disclosure. In one aspect, the end effector is configured for asymmetrical engagement of the clamping arm, the electrode, and the clamping arm pad to achieve ultrasonic scalpel / RF electrode interaction. 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 scalpel is the opposite pole of the bipolar RF circuit.

[0214] In one aspect, the distal end of the clamping arm is shortened while the length of the clamping arm pad remains the same, such that the distal end of the clamping arm pad extends beyond the distal end of the clamping arm. This allows the electrode to extend excessively to minimize the possibility of an electrical short circuit at the distal end of the clamping arm. This also has the beneficial effect of extending the life of the clamping arm pad, as any additional exposed clamping arm pad material will wear through. This configuration also eliminates the need for a clamping arm pad with distal and intermediate gaps, which is previously referred to herein as, for example, an abrasive clamping arm pad, for setting and maintaining the gap between the electrode and the ultrasonic scalpel.

[0215] Figure 10 This is a side view of an end effector 1680 comprising a shortened clamping arm 1682, an ultrasonic scalpel 1684, an electrode 1686, and a clamping arm pad 1688, according to at least one aspect of this disclosure. Figure 11 This is a top view of the end effector 1680. (See attached image.) Figures 10 to 11 As shown, the ultrasonic scalpel 1684 and the electrode 1686 are substantially the same length. The clamping arm 1682 is shortened to allow the electrode 1686 to extend excessively to prevent electrical short circuits. In one aspect, a gap setting pad 1690 is provided at the proximal end 1692 of the end effector 1680.

[0216] Figure 12 A clamping arm 1700, comprising a clamp 1702, an electrode 1704, and a clamping arm pad 1706, is shown according to at least one aspect of this disclosure. The distal space of the clamping arm is released. The clamping arm 1700 is configured for use with an end effector comprising an ultrasonic scalpel as disclosed in other sections herein. This configuration releases a distal space 1708 on the clamp 1702. The clamping arm pad 1706 (e.g., PTFE) is fully supported underneath, but space is released in the T-groove region and on the sidewalls to allow further burn-through of the clamping arm pad 1706 and further deflection of the electrode 1704 away from the ultrasonic scalpel (not shown).

[0217] In one aspect, this disclosure provides an end effector that utilizes the thermal behavior of a pad to deflect an electrode. In one aspect, the length of the clamping arm pad may be the same as the length of the ultrasonic scalpel, and the thermal expansion properties of the clamping arm pad material (e.g., PTFE) can be used to deflect the electrode out of the path of the ultrasonic scalpel as the clamping arm pad expands or changes shape due to pressure or heat.

[0218] In one aspect, a non-biased electrode and a pad are provided. As the pad wears, the non-biased but deflectable pad changes its position relative to the clamping arm. The non-biased electrode is configured to minimize contact between the ultrasonic scalpel and the RF electrode. The clamping arm pad includes features for securing the electrode to the clamping arm pad. In one aspect, as the clamping arm pad wears or is cut through, the height of the electrode relative to the clamping arm is adjusted progressively. In another aspect, once the clamping arm is removed from the ultrasonic scalpel, the electrode remains in its new position. The electrode is secured to the clamping arm at its proximal end and freely deflects at its distal end. Therefore, throughout this disclosure, the electrode may be referred to as a cantilever electrode or a deflectable electrode.

[0219] Including the above about Figures 1 to 12 The configuration of the end effector of the deflectable / cantilever electrode can be similar to that described below. Figures 13 to 18 The aforementioned bias electrode assembly.

[0220] In one aspect, this disclosure provides an end effector for a combined ultrasonic / bipolar RF energy surgical device, wherein the end effector uses pressure or clamping compression to adjust the height of the electrode as the clamping arm pad wears. In one aspect, the clamping arm pad follows a clamping arm biasing electrode with a wear-resistant stop. In another aspect, the clamping 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 clamping arm is adjusted progressively. Once the clamping arm is removed from the ultrasonic scalpel, the electrode remains in its new position.

[0221] Achieving sufficient clamping arm pad life in a combined ultrasound / bipolar RF energy surgical device requires maintaining a sufficiently small, but non-zero, clamping arm pad-electrode gap throughout the device's lifespan to provide the desired ultrasound and bipolar RF tissue effects. The electrodes are adapted and configured for use with the combined ultrasound / bipolar RF energy surgical device and are capable of deflection under load, wherein the electrode is one pole of the bipolar RF circuit and the ultrasonic scalpel is the opposite pole of the bipolar RF circuit.

[0222] The existing (seed) electrode is a flat electrode that is practically horizontal or parallel to the clamping arm in its free state (no load). The electrode is fixed to the clamping arm at its proximal end and freely deflects at its distal end. Therefore, throughout this disclosure, the electrode may be referred to as a cantilever beam electrode or a deflectable / cantilever electrode. When clamped on tissue, the tissue applies a load to the electrode, causing it to deflect toward the clamping arm.

[0223] In one aspect, as the pad wears, the electrode “follows” the pad. In this aspect, using any suitable fastening technique, such as welding, laser welding, brazing, soldering, pressing, and other fastening techniques, the electrode is biased toward the free-standing clamping arm (whether by forming / bending the electrode or by attaching / welding the electrode not parallel to the clamping arm). Wearable stop features (on the pad or elsewhere) keep the electrode away from the clamping arm until said stop features are worn away during use. Once worn away, the electrode can then approach the clamping arm. These features can be toothed or ratchet-shaped, vertically tapered, or others.

[0224] In one aspect, this disclosure provides a deflectable / cantilevered electrode, wherein in a free state the electrode is biased toward a clamping arm and can be attached at an angle and formed into a pre-shaped curve using any suitable fastening technique (such as welding, laser welding, brazing, soldering, pressing, and other fastening techniques).

[0225] In one aspect, this disclosure provides an end effector having a deflectable / cantilevered electrode including wear-resistant stop features to prevent the electrode from reaching or contacting a clamping arm. As the stop features wear, the electrode moves toward the clamping arm until it reaches the next stop. In another aspect, the stop features wear simultaneously with the clamping arm pad to maintain a proper clearance between the clamping arm pad and the electrode. These features can be completely separable from the clamping arm pad. These features can be configured to withstand clamping loads but are worn away due to heat (melting / flow) or abrasion. Possible examples include teeth on one or more clamping arm pads (PTFE, polyimide, or others) and tapered profiles on one or more clamping arm pads (PTFE, polyimide, or others).

[0226] Figure 13 An end effector clamping arm 1710 according to at least one aspect of the present disclosure is shown, comprising a clamp 1712, an electrode 1714, and a clamping arm pad 1716. The clamping arm 1710 is configured for use with an end effector including an ultrasonic scalpel (not shown) as described throughout the present disclosure. The clamping arm 1710 also includes a wear-resistant clearance pad 1717 to establish a gap between the electrode 1714 and the ultrasonic scalpel. As shown, in the free state, the electrode 1714 is biased in a flat or horizontal direction 1718. The electrode 1714 is secured to the clamp 1712 at its proximal end and freely deflects at its distal end. Therefore, throughout the present disclosure, the electrode 1714 may be referred to as a cantilever electrode or a deflectable electrode.

[0227] Figure 14An end effector clamping arm 1720 according to at least one aspect of the present disclosure is shown, comprising a clamp 1722, an electrode 1724, and a clamping arm pad 1726. The clamping arm 1720 is configured for use with an end effector including an ultrasonic scalpel (not shown) as described throughout the present disclosure. The clamping arm 1720 also includes a wear-resistant clearance pad 1727 to establish a gap between the electrode 1724 and the ultrasonic scalpel. As shown, in its free state, the electrode 1724 is configured to be pre-shaped, bent, or otherwise oriented along line 1728 away from the horizontal plane 1718 and biased toward the clamp 1722. The electrode 1724 is secured to the clamping arm 1720 at its proximal end and freely deflected at its distal end. Therefore, throughout the present disclosure, the electrode 1724 may be referred to as a cantilever electrode or a deflectable electrode. To prevent the biased electrode 1724 from bending toward the clamp 1722 under the influence of the biasing force, the clamping arm 1720 also includes a retainer to prevent the biased electrode 1724 from bending toward the clamp 1722 and to hold the biased electrode 1724 in a generally flat configuration relative to the ultrasonic scalpel (e.g., parallel, flat, or horizontal). Below... Figures 15 to 18 Examples of retainers (such as retainer teeth 1738 and retainer walls 1760 with tapered profiles) are described in the text.

[0228] Figure 15 An end effector clamping arm 1730, comprising a clamp 1732, an electrode 1734, and a clamping arm pad 1736, is shown according to at least one aspect of the present disclosure. The clamping arm 1730 is configured for use with an end effector including an ultrasonic scalpel (not shown) as described throughout the present disclosure. The clamping arm 1730 also includes a wear-resistant clearance pad 1737 to establish a gap between the electrode 1744 and the ultrasonic scalpel. In its free state, the electrode 1734 is configured to be pre-formed, bent, or otherwise biased toward the clamp 1732. However, retainer teeth 1738 or similar features are provided on the clamping arm pad 1736 to prevent the electrode 1734 from springing toward the clamp 1732. Figure 16 In this disclosure, according to at least one aspect, when the bottom retainer teeth 1738 are worn away, the electrode 1734 can move toward the clamp 1732 due to a pre-shaped curve. The electrode 1734 is fixed to the clamping arm 1730 at its proximal end and freely deflects at its distal end. Therefore, throughout this disclosure, the electrode 1734 may be referred to as a cantilever beam electrode or a deflectable electrode.

[0229] Figure 17An end effector clamping arm 1750 according to at least one aspect of the present disclosure is shown, comprising a clamp 1752, an electrode 1754, and a clamping arm pad 1756. The clamping arm 1750 is configured for use with an end effector including an ultrasonic scalpel (not shown) as described throughout the present disclosure. The clamping arm 1750 also includes a wear-resistant clearance pad 1757 to establish a gap between the electrode 1754 and the ultrasonic scalpel. In its free state, the electrode 1754 is configured to be pre-shaped with a curve, bend, or otherwise biased toward the clamp 1752 1758. However, a retainer wall 1760 or similar feature with a tapered profile is provided on the clamping arm pad 1756 to prevent the electrode 1754 from springing toward the clamp 1752.

[0230] exist Figure 17 In accordance with at least one aspect of this disclosure, when the tapered profile retainer wall 1760 is worn away, there is sufficient melting / flow away from the region of the tapered profile retainer wall 1760 to allow the electrode 1754 to move toward the clamp 1752 due to the pre-formed curve. The electrode 1754 is fixed to the clamp 1752 at its proximal end and freely deflects at its distal end. Therefore, throughout this disclosure, the electrode 1754 may be referred to as a cantilever beam electrode or a deflectable electrode.

[0231] In one aspect, this disclosure provides an end effector for a combined ultrasound / bipolar RF energy surgical device, the end effector employing a constant pressure distribution biasing mechanism. In one aspect, the end effector includes an elastic compressible support for mounting a deflectable electrode and insulating the deflectable electrode. In one aspect, a hollow, honeycomb-like or chambered elastomeric support attachment pad may be used to allow all or part of the electrode attached thereto to be deflected but biased toward the ultrasonic scalpel. This configuration provides the additional beneficial effect of thermally insulating the electrode from the remainder of the metal clamp. This also provides an elastomeric “curtain” around the electrode to minimize tissue buildup behind the electrode. In one aspect, a non-strut deflectable geometry adapted to the elastomeric unit will keep the deflection force constant within a predetermined deflection range. The electrode is adapted and configured for use with the combined ultrasound / bipolar RF energy surgical device and is capable of deflection under load, wherein the electrode is one pole of the bipolar RF circuit and the ultrasonic scalpel is the opposite pole of the bipolar RF circuit.

[0232] The above configuration prevents the electrodes from laterally deflecting under compression to prevent short circuits. Furthermore, the deflectable electrode is attached to an elastomer, which in turn is attached to the metal clamping arms. The physical height of the spring is limited by the amount of compression allowed by the drive, while maintaining as much of the metal clamping arm as possible. Heat conduction from the tissue interface is balanced and minimized – impacting damage formation and symmetry, cycle time, and residual heat energy.

[0233] Including the above about Figures 1 to 12 The configuration of the end effector of the deflectable / cantilever electrode can be combined with a flexible electrode disposed above a mesh liner and multiple rigid spacers to establish a gap between the flexible electrode and the ultrasonic scalpel, as described below. Figures 19 to 21 As stated above.

[0234] As mentioned above Figures 13 to 18 The configuration of the bias electrode can be combined with a flexible electrode disposed above the mesh liner and multiple rigid spacers to establish a gap between the flexible electrode and the ultrasonic scalpel, as described below. Figures 19 to 21 As stated above.

[0235] Including the above about Figures 1 to 12 The deflectable / cantilever electrode mentioned above is related to the above. Figures 13 to 18 The configuration of the end effector of the bias electrode combination can be combined with a flexible electrode disposed above the mesh pad and multiple rigid spacers to set a gap between the flexible electrode and the ultrasonic scalpel, as described below. Figures 19 to 21 As stated above.

[0236] Figures 19 to 20 An end effector 1810 according to at least one aspect of the present disclosure is shown, the end effector including a clamping arm 1812, an ultrasonic scalpel 1814, a mesh pad 1816, a flexible electrode 1818 disposed above the mesh pad 1816, and a plurality of rigid spacers 1820 for setting a gap between the flexible electrode 1818 and the ultrasonic scalpel 1814. Figure 21 yes Figures 19 to 20 An exploded view of the end effector 1810 is shown. A clamping arm pad 1822 is disposed within a groove 1825 formed within a mesh pad 1816. The mesh pad 1816 serves as a spring-like element. A rigid spacer 1820 is used to create a gap between the flexible electrode 1818 and the ultrasonic scalpel 1814.

[0237] exist Figure 19 In the middle, the clamping arm 1812 is open and has uneven thickness (T 1a T 2a T 3a The tissue 1824 is disposed above the flexible electrode 1818. Figure 20 In the middle, the clamping arm 1812 closes to compress tissue 1824. The mesh pad 1816 on the clamping arm 1812 results in a variable thickness tissue 1824 (T 1a T 2a T 3a ) has a consistent organization 1824 (T) 1b T 2b T 3b Compression makes:

[0238]

[0239] Further background information can be found in EP3378427 and WO2019 / 006068, the full text of which is incorporated herein by reference.

[0240] 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 another aspect, 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.

[0241] Including the above about Figures 1 to 12 The configuration of the end effector of the deflectable / cantilever electrode can be similar to that described below. Figures 22 to 36 The aforementioned conductive polymer clamping arm pad assembly.

[0242] As mentioned above Figures 13 to 18 The configuration of the bias electrode can be similar to that described below. Figures 22 to 36 The aforementioned conductive polymer clamping arm pad assembly.

[0243] Flexible electrodes positioned above the mesh pad and as described above Figures 19 to 21 The configuration of the plurality of rigid spacers used to set the gap between the flexible electrode and the ultrasonic scalpel can be related to the following text regarding... Figures 22 to 36 The aforementioned conductive polymer clamping arm pad assembly.

[0244] As mentioned above Figures 13 to 18 The configuration of the bias electrode can be combined with a flexible electrode disposed above the grid pad, and as described above regarding Figures 19 to 21 The plurality of rigid spacers used to set the gap between the flexible electrode and the ultrasonic scalpel can be related to the following text regarding... Figures 22 to 36 The aforementioned conductive polymer clamping arm pad assembly.

[0245] As mentioned above Figures 13 to 18The configuration of the bias electrode can be combined with a flexible electrode disposed above the grid pad, and as described above regarding Figures 19 to 21 The plurality of rigid spacers used to set the gap between the flexible electrode and the ultrasonic scalpel can be related to the following text regarding... Figures 22 to 36 The aforementioned conductive polymer clamping arm pad assembly.

[0246] Including the above about Figures 1 to 12 The deflectable / cantilever electrode mentioned above is related to the above. Figures 13 to 18 The configuration of the end effector with the aforementioned combination of bias electrodes is similar to that described below regarding... Figures 22 to 36 The aforementioned conductive polymer clamping arm pad assembly.

[0247] Including the above about Figures 1 to 12 The deflectable / cantilever electrode mentioned above is related to the above. Figures 13 to 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 Figures 19 to 21 The plurality of rigid spacers used to set the gap between the flexible electrode and the ultrasonic scalpel can be related to the following text regarding... Figures 22 to 36 The aforementioned conductive polymer clamping arm pad assembly.

[0248] 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 / abrasion 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 disrupting the conductivity of the remaining portion of the conductive clamping arm pad.

[0249] 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 22This is a cross-sectional view of a conductive polymer gripping arm pad 2440 according to at least one aspect of this disclosure. The conductive polymer gripping arm pad 2440 includes tin oxide 2442 (SnO2) embedded in a polymer material 2444 such as polytetrafluoroethylene (PTFE) to make the gripping arm pad 2440 conductive. Doping can be achieved using a cold spraying process. Once doped, the conductive polymer gripping arm pad 2440 can perform the functions of a conventional ultrasonic tissue gripping arm pad, such as, for example, contacting an ultrasonic scalpel, absorbing heat from the ultrasonic scalpel, and aiding in tissue gripping and holding. The tin oxide-doped gripping arm pad 2440 serves as one of the two electrodes or poles of a bipolar RF circuit to deliver RF energy to tissue gripped between the ultrasonic scalpel and the gripping arm pad 2440. The tin oxide-doped gripping arm pad 2440 is biocompatible, conductive, and thermally conductive, allowing a large portion of the gripping arm pad 2440 to be used to improve its abrasion resistance, and is white. The electrode is adapted and configured for use with a combined ultrasound / bipolar RF energy surgical device and is deflectable under load, wherein the electrode is one pole of the bipolar RF circuit and the ultrasonic scalpel is the opposite pole of the bipolar RF circuit.

[0250] In one aspect, this disclosure provides a conductive polymer ultrasonic clamping arm pad as an electrode replacement. To extend the lifespan of the ultrasonic clamping arm pad and improve the RF tissue effect, this disclosure provides an improved electrode that is easier to manufacture and has a lower manufacturing cost. In another aspect, this disclosure provides a clamping arm pad comprising a rigid polyimide polymer layer and a conductive layer, allowing the clamping arm pad to perform conventional functions and carry bipolar electricity, thereby eliminating the need for a separate electrode in the clamping arm of a combined energy end effector. Thus, the clamp can be manufactured in a manner similar to a pure ultrasonic clamp, wherein the new clamping arm pad material is interchangeable with conventional pure ultrasonic clamping arm pads. 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 a bipolar RF circuit and the ultrasonic scalpel is the opposite pole of the bipolar RF circuit.

[0251] Beneficial effects include improved ultrasonic performance, including gripper arm pad wear, similar to current pure ultrasonic instruments because there are no electrode gaps between the polymer element "squares". Since no separate electrode components are needed and multiple small polymer square elements are provided, the cost of the improved clamp will be similar to that of current pure ultrasonic clamps. Furthermore, the manufacturing steps required to manufacture the clamp are the same as those required to manufacture current pure ultrasonic clamps. Manufacturing this improved clamp only requires replacing the gripper arm pads and does indeed require producing additional electrode components to add to the clamp, and eliminates the assembly step.

[0252] Figure 23This is a perspective view of a clamping arm pad 2450 configured to replace conventional electrodes according to at least one aspect of this disclosure. The clamping arm pad 2450 includes a sandwich-like configuration of a non-conductive layer 2452 and a conductive layer 2454. This configuration eliminates the need for spring-loaded electrode plates. The non-conductive layer 2452 may be made of polymers, polyimides, polytetrafluoroethylene (PTFE), and similar non-conductive materials. The conductive layer 2454 may be made of a thin conductive polymer, metal foil, or carbon-loaded material. The clamping arm pad 2450 may be manufactured such that the majority of the material in contact with the ultrasonic scalpel is the non-conductive layer 2452. In one aspect, 75% of the material in contact with the ultrasonic scalpel is a non-conductive material, such as PTFE. In another aspect, 85% of the material in contact with the ultrasonic scalpel is a non-conductive material, such as PTFE. In yet another aspect, 95% of the material in contact with the ultrasonic scalpel is a non-conductive material, such as PTFE. Additionally, as the clamping arm pad 2450 wears, the conductive layer 2452 will still have usable surface area for conducting RF power through tissue and return electrodes (e.g., ultrasonic scalpel).

[0253] Figure 24 The present disclosure illustrates at least one aspect including Figure 23 The clamping arm 2460 of the clamping arm pad 2450. In the clamping arm 2460 shown, the non-conductive layer 2452 has a large surface area compared to the conductive layer 2454, which is presented as a thin layer or foil.

[0254] Figure 25 At least one aspect of this disclosure is shown as follows Figures 23 to 24 The clamping arm pads are constructed as described herein. The first clamping arm pad 2470 is new and includes teeth 2472 integrally formed therewith. The second clamping arm pad 2476 is new but has no teeth. The third clamping arm pad 2478 is worn and may represent either the first clamping arm pad 2470 or the second clamping arm pad 2476.

[0255] In one aspect, this disclosure provides a composite material clamping arm pad for a combined ultrasound / bipolar RF energy surgical device. Figure 26This is a cross-sectional view of a clamping arm 2480 including a composite material clamping arm pad 2482 in contact with tissue 2484, according to at least one aspect of this disclosure. The end effector 2480 includes an upper clamp 2486 and an adhesive 2488 for securely attaching the composite material clamping arm pad 2482 to the upper clamp 2486. The composite material clamping arm pad 2482 includes a thin non-conductive layer 2490 (e.g., PTFE) and a thin conductive layer 2492 (e.g., a thin stainless steel foil). The conductive layer 2492 forms the electrode portion of the composite material clamping arm pad 2482. As the non-conductive layer 2490 (e.g., PTFE) wears away, the conductive layer 2492 (e.g., the thin stainless steel foil) deforms. The thickness of the conductive layer 2492 allows the electrode portion of the composite material clamping arm pad 2482 to deform as the non-conductive layer 2490 wears away. Advantageously, the conductive layer 2492 conducts some heat away from the non-conductive layer 2490 to keep the composite clamping arm pad 2482 relatively cool. As described above, the composite clamping arm pad 2482 is secured to the upper clamp 2486 by an adhesive 2488. The adhesive 2488 may be filled with carbon to make it conductive and to attach the electrode portion of the composite clamping arm pad 2482 to the upper clamp 2486. The electrode is adapted and configured for use with a combined ultrasound / bipolar RF energy surgical device and is capable of deflection under load, wherein the electrode is one pole of the bipolar RF circuit and the ultrasonic scalpel is the opposite pole of the bipolar RF circuit.

[0256] In one aspect, the clamping arm pad includes cooperating conductive and insulating portions. In another aspect, this disclosure provides a combined ultrasound / bipolar RF energy surgical device wherein the clamping arm pad has conductive and non-conductive portions, allowing it to function as one electrode in an RF electrode array while also serving as an abrasive support structure for an ultrasonic scalpel. In another aspect, the conductive portion of the clamping arm pad is disposed around the periphery of the pad and is not directly positioned on the side opposite the contact area with the ultrasonic scalpel. In yet another aspect, the conductive portion of the clamping arm pad is degradable or abrasive to prevent contact with the ultrasonic scalpel from disrupting the conductivity of the remaining conductive portion of the conductive clamping arm pad.

[0257] In one aspect, this disclosure provides a clamping arm pad for use with a combined ultrasonic / bipolar RF energy device, wherein a portion of the clamping arm pad comprises a conductive material, while other portions comprise a non-conductive material. Electrodes are adapted and configured for use with the combined ultrasonic / RF energy 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.

[0258] 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.

[0259] 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.

[0260] 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 28-28Figures 29-29 show a clamping arm 2500 including a clamp 2502, a support bracket 2504, a conductive pad 2508, and a non-conductive pad 2510.

[0261] Figure 30 This is a cross-sectional view of an alternative embodiment of a clamping arm 2520 comprising a clamp 2522, a conductive pad 2524, and a non-conductive pad 2526, according to at least one aspect of this disclosure. The conductive pad 2524 is made of a conductive polymer and serves as one of the electrodes in a bipolar RF circuit.

[0262] Figure 31 This is a cross-sectional view of an alternative embodiment of a clamping arm 2530 comprising a clamp 2532, a bracket 2534 welded to the clamp 2532 or a stamped part, a conductive pad 2536, and a non-conductive pad 2538, according to at least one aspect of this disclosure. The conductive pad 2536 is made of a conductive polymer and serves as one of the electrodes in a bipolar RF circuit. The conductive pad 2536 is overmolded or stamped onto the bracket 2534.

[0263] In one aspect, the end effector gripper arm includes a membrane-coated metal insert-molded electrode assembly. In another aspect, a membrane may be provided on the metal (e.g., stainless steel) insert-molded electrode assembly. The membrane-coated metal, such as stainless steel, can be formed into the electrode assembly in an insert-molding manner. The membrane on the insert-molded electrode can be etched to form micropores, slits, honeycombs, and other patterns to conduct RF energy and cut the periphery of the part. The membrane 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 charged membrane electrode can be placed in a polymer injection mold to mold the polymer to the back side of the electrode and the membrane. The electrode is adapted and configured for use with a combined ultrasound / bipolar RF energy surgical device and is deflectable 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.

[0264] Figure 32 An insert-molded electrode 2540 according to at least one aspect of the present disclosure is shown. The insert-molded electrode 2540 includes a conductive element 2546, a molded polymer pad 2548, and a membrane 2542 coating. Features 2550, such as micropores, slits, honeycombs, or similar features, are formed in the membrane 2542 to allow RF energy to pass through. A retaining feature 2552 is also formed on the membrane 2542. Sidewalls 2558 of the membrane 2542 extending below the bottom of the polymer pad 2548 are foldable around the bottom of the polymer pad 2548 and molded to cover a retaining post. The retaining feature 2552 is molded into an aperture 2554 defined by the membrane 2542. Although a gap exists between the two insert-molded electrodes 2540 shown, in practice, the two insert-molded electrodes 2540 are mated via a molding pressure wire-to-wire 2556.

[0265] The conductive element 2546 may be made of a conductive metal such as stainless steel or a similar conductive material. The conductive element 2546 may be about 0.010" thick and can be selected in the thickness range of 0.005" to 0.015" and can be formed by tamping or machining. The membrane 2544 may be about 0.001" to 0.002" thick and may be made of polyimide, polyester, or similar materials. As an alternative to mechanical retention such as a column, the membrane 2544 may be directly bonded to the conductive element 2546. One example includes a DuPont Pyralux HXC Kapton membrane with an epoxy adhesive backing and a thickness of 0.002"

[0266] Advantageously, the non-stick surface prevents tissue from adhering to the insert-molded electrode 2540. By providing a gap ranging from 0.002" to 0.004" along the entire length of the insert-molded electrode 2540, the non-stick surface avoids short circuits between opposite electrodes. Due to the coverage of the sidewalls 2558 of the insert-molded electrode 2540, the non-stick surface minimizes the lateral propagation of RF energy. Furthermore, the insert-molded electrode 2540 exhibits structural robustness and provides easier and more robust electrical connections than multilayer flexible circuits.

[0267] In one aspect, the end effector includes a conductive gripping arm and pad configuration for a combined ultrasonic / bipolar RF energy surgical device. In another aspect, this disclosure provides a gripping arm assembly including a conductive or selectively conductive film, foil, or laminate applied to, surrounding, or on the gripping arm assembly to serve as a durable “pole” in the combined ultrasonic / bipolar RF energy surgical device. Furthermore, algorithms, software, or logic are provided to manage conditions for electrical short circuits. Electrodes are adapted and configured for use with the combined ultrasonic / bipolar RF energy surgical device and are deflectable 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.

[0268] Figure 33 An end effector 2560 comprising an ultrasonic scalpel 2562, a clamping arm 2564, and a clamping arm pad 2566 including a conductive film 2568, is shown according to at least one aspect of the present disclosure.

[0269] Figure 34 It shows Figure 33 The clamping arm 2564 is shown. The clamping arm 2564 includes a clamp 2570 to support the clamping arm pad 2566. A thin conductive film 2568 is disposed on the clamping arm pad 2566 to form an electrode of one of the poles of a bipolar RF circuit.

[0270] Figure 35 It is along Figure 34The image shows a cross-sectional view of the clamping arm 2564 taken at section 35-35. The clamp 2570 may be made of a metal such as stainless steel. The clamping arm pad 2566 may be made of a non-conductive flexible material such as PTFE, silicone, high-temperature polymer, or similar materials. The conductive film 2568 or foil may be made of a conductive material such as titanium, silver, gold, aluminum, zinc, and any alloy thereof (including stainless steel).

[0271] Figure 36 A clamping arm 2580, comprising a partially conductive clamping arm pad 2582, is shown according to 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 establishes a gap between the clamping arm pad 2582 and the ultrasonic scalpel.

[0272] The conductive film 2568, foil, or laminate may comprise, for example, a single-layer thin conductive material, such as a metal (titanium, silver, gold, zinc, aluminum, magnesium, iron, etc., and their alloys or stainless steel), a plated metal (e.g., copper plated with nickel first, then gold), or a polymer substantially filled with a conductive material such as metal powder or filler. Preferably, it is a biocompatible metal foil, such as titanium, silver, gold, zinc, or stainless steel, having a thickness selected from 0.001" to 0.008" (0.025 mm to 0.20 mm).

[0273] The membrane 2568, foil, or laminate may include a thin polymer coating, film, or layer covering the aforementioned thin conductive material. This coating, film, or layer is highly resistive; that is, it is not an effective conductor for bipolar RF energy to adjacent tissue. The coating may be perforated to allow energy delivery from the electrode to the tissue.

[0274] The conductive material may be perforated or include holes or windows throughout its full thickness to minimize the heat capacity of the layer (tests have shown that long and / or thick foils result in longer traverse times due to heat removal from the treatment line of sight). These perforations, holes, or windows may also allow the foil to be held to other portions or layers. These perforations, holes, or windows may be patterned across the entire foil sheet or positioned at or away from the treatment site, such as, for example, only on the side of the clamping arm.

[0275] If present, the thin polymer coating, film, or layer may be perforated or include full-thickness holes or windows, allowing the conductive film, foil, or laminate to be in direct communication with the tissue for the delivery of bipolar radio frequency energy to the tissue. For coatings, these holes or windows can be formed through selective coating or coating removal.

[0276] Ideally, the conductive film 2568, foil, or laminate is in direct contact with the clamping arm structure, typically made of stainless steel. This results in a simple conductive path, as the path is formed by the necessary structural components: a support tube or actuator directly connected to the clamping arm and then to the conductive film, foil, or laminate.

[0277] In one aspect, the conductive film 2568, foil, or laminate is supported by a relatively soft, high-temperature, low-abrasion polymer or elastomer pad made of 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 clearance between the clamp and the ultrasonic scalpel along its entire tissue action length when the clamp is fully closed, thereby enabling sealing and cutting of tissue along that length. The compliance also eliminates or significantly attenuates any audible vibrations that may occur in the conductive layer when the ultrasonic scalpel approaches it.

[0278] The conductive film 2568, foil, or laminate may include a rigid to semi-rigid polymer on its back / back surface (i.e., the surface away from the tissue and facing the clamping arm). The component is made of a polymer or polymer alloy that can be injection molded and is adhered to the film, foil, or laminate by film insert molding (FIM) or in-mold labeling (IML).

[0279] In testing, thin stainless steel, copper, or aluminum foil operated quietly (without a "scream" or dull squeak). The thin stainless steel, copper, or aluminum foil provides a robust surface for the ultrasonic scalpel to work on. It is strong enough that materials that would otherwise tear and be used as poor padding materials, such as silicone rubber, are usable and do not easily tear or crack.

[0280] The proximal portion of the clamping surface may not include conductive film, foil, or laminate, because this area of ​​the clamp is the first to contact the blade and is more likely to cause power shunting / short circuits in this area.

[0281] In one aspect, this disclosure provides a short-circuit mitigation algorithm for activating an output that includes bipolar RF energy.

[0282] No short circuit alarm will be given to the user if the energy delivered for activation exceeds the threshold amount (which indicates that the tissue is thinning but may have received a sufficient dose of bipolar RF energy for sealing and coagulation of the tissue), or exceeds the activation time threshold (again, which indicates that the tissue is thinning but may have received a sufficient dose), or exceeds both the energy threshold and the activation time threshold.

[0283] The process for fabricating a film-coated stainless steel insert molded electrode assembly includes: etching a film and forming holes (micropores, grooves, or honeycombs) for transmitting RF energy; cutting the periphery of the electrode component; forming a film on a stainless steel electrode if necessary; bonding a film to a stainless steel electrode; placing the charged film and electrode in a polymer injection mold; and molding the polymer onto the back of the electrode and film.

[0284] In various aspects, this disclosure provides a combined ultrasound / bipolar RF energy surgical device including an ultrasound pad configuration. The end effector includes a compression element to limit heat generation in either the end effector or its components. In one aspect, this disclosure provides an asymmetric segmented ultrasound support clamping arm pad that engages with a movable RF electrode configured for use with the combined ultrasound / RF energy device. In another aspect, the asymmetric segmented ultrasound support clamping arm pad extends at least partially through the RF electrode. In another aspect, at least one element of the clamping arm pad is significantly higher than a second element of the clamping arm pad. In another aspect, a first clamping arm pad extends completely through the electrode, and a second clamping arm pad extends only partially through the electrode. In another aspect, the first element and the second element of the clamping arm pad are made of different materials. Further background material can be found in U.S. Patent Publication No. 2017 / 0164997, the entire contents of which are incorporated herein by reference.

[0285] In one aspect, the end effector includes a deflectable electrode configuration. In another aspect, this disclosure provides a segmented ultrasonic support clamping arm pad that at least partially extends through an RF electrode. In another aspect, at least one pad element is significantly higher than a second pad element. In another aspect, a first pad element extends entirely through the electrode, and a second pad element extends partially through the electrode. In another aspect, the first pad element and the second pad element are made of different materials.

[0286] In one aspect, this disclosure provides an electrode comprising destructive and non-destructive portions. Figures 1 to 9 The description is incorporated herein by reference. Figures 1 to 9 The clamping arm pad 1010 shown provides a large area of ​​elastic (e.g., PTFE) padding while still allowing the electrode 1004 to deflect. The electrode is secured to the clamp at the proximal end and freely deflects at the distal end. Therefore, throughout this disclosure, the electrode may be referred to as a cantilever electrode or a deflectable electrode. The electrode is adapted and configured for use with a combined ultrasound / bipolar RF energy surgical device and is capable of deflection under load, wherein the electrode is one pole of the bipolar RF circuit and the ultrasonic scalpel is the opposite pole of the bipolar RF circuit.

[0287] In one aspect, the end effector includes a clamping arm pad with an I-beam configuration. An I-beam clamping arm pad (e.g., Teflon or PTFE) is provided such that the bottom of the clamping arm pad slides into the clamping arm, and the top of the clamping arm pad slides over the electrode. The top portion of the clamping arm pad may be shaped into a modified pebble form to increase the electrode surface area on the side opposite the ultrasonic scalpel. This configuration also provides pads at the centerline and flange of the clamping arm pad above the electrode to prevent delamination between the clamping arm pad and the clamping arm. A proximal hard (e.g., polyimide) gap setting pad slides in from the rear (proximal end) to provide a gap setting structure and a "plug" to hold the clamping arm pad in place.

[0288] Figures 37 to 39 A clamping arm 1990 according to at least one aspect of the present disclosure is shown, the clamping arm including an I-beam shaped clamping arm pad 1992 configured for use with an end effector including a clamp 1994, an ultrasonic scalpel (not shown), and an electrode 1996. The clamping arm pad 1992 has an I-beam configuration including a top transverse portion 1998 and a bottom transverse portion 2000 separated by a middle portion 2002 to define a cross-sectional shape defined as “I”. The electrode 1996 is disposed between the top transverse portion 1998 and the bottom transverse portion 2000 of the I-beam shaped clamping arm pad 1992. The electrode 1996 is secured to the clamp 1994 at a proximal end and freely deflected at a distal end. Therefore, throughout the present disclosure, the electrode 1996 may be referred to as a cantilever beam electrode or a deflectable electrode. The clamp 1994 defines a longitudinal groove 2010 to slidably receive a portion of the bottom lateral portion 1998, 2000 and the middle portion 2002 of the I-beam shaped clamping arm pad 1992 passing through it.

[0289] Figure 38 This is a top view of the clamping arm 1990, showing the clamping arm pad 1992 as viewed from above the electrode 1996. Figure 39 This is a top view of electrode 1996, showing a longitudinal groove 2010 for slidably receiving clamping arm pad 1992 therein. (Reference) Figures 38 to 39 The top portion 1998 (referred to as the flange) of the I-beam segment of the clamping arm pad 1992 is positioned above the electrode 1996 to prevent delamination between the clamping arm pad 1992 and the clamp 1994. A hard, wear-resistant gap setting pad 2004 for setting a gap between the electrode 1996 and the ultrasonic scalpel (not shown) is also shown in this view. The electrode 1996 is securely attached to the clamp 1994 by welding the proximal end 2006 of the deflectable electrode 1996 to the clamp 1994 at welding point 2008. Other attachment techniques may be used, such as laser welding, brazing, soldering, pressing, and other fastening techniques.

[0290] Figures 40A to 40CAssembly according to at least one aspect of this disclosure is shown. Figures 37 to 39 The method of the clamping arm 1990 shown. Figure 40A In this configuration, electrode 1996 is welded to the proximal end 2006 of clamp 1994 at welding point 2008. Figure 40B In the middle, the clamping arm pad 1992 is slidably inserted into the longitudinal groove 2010. Figure 40C In the clamp 1994, a hard, wear-resistant gap setting pad 2004 for setting the gap is slidably inserted.

[0291] Combination Figures 37 to 40C The described clamping arm 1990 provides an electrode 1996 that deflects when clamped onto tissue. Tissue buildup points between segments of the clamping arm pad 1992 are eliminated, and delamination of the electrode 1996 is minimized. The clamping arm 1990 also eliminates the need for a small-gap setting pad and is easy to manufacture.

[0292] In one aspect, the end effector includes an interactive electrode recess and an ultrasonic scalpel support feature. Figures 41 to 43 An end effector 2020 according to at least one aspect of the present disclosure is shown, the end effector including an electrode 2026 defining a recess 2030 at an overlap position with an ultrasonic scalpel 2024 to minimize impact between the ultrasonic scalpel 2024 and the electrode 2026. Figure 41 This is a cross-sectional view of an end effector 2020 comprising a clamping arm 2022, an ultrasonic scalpel 2024, an electrode 2026, and a heavy polymer support pad 2028 (e.g., a polyamide pad) according to at least one aspect of this disclosure. Figure 42 This is a cross-sectional view of the end effector 2020, in which the heavy polymer support pad 2028 is worn and tissue 2032 is clamped between the clamping arm 2022 and the ultrasonic scalpel 2024. In the clamped state, the electrode 2026 is substantially flush with the ultrasonic scalpel 2024. Figure 43 This is an enlarged view of the end effector 2020. In the fully clamped state, the electrode 2026 is substantially flush with the ultrasonic scalpel 2024. When the ultrasonic scalpel 2024 rests in the recess 2030 defined by the heavy polymer support pad 2028, the plane 2034 defined by the top of the electrode 2026 and the plane 2036 defined by the bottom of the ultrasonic scalpel 2024 are substantially flush or horizontal when the ultrasonic scalpel is resting in the recess 2030 defined by the heavy polymer support pad 2028.

[0293] Now for reference Figures 41 to 43 Along the centerline of electrode 2026 (C LElectrode 2026 defines a recess 2029, and heavy polymer support pad 2028 defines an integrated recess 2030 corresponding to the position of ultrasonic scalpel 2024 to minimize interaction between electrode 2026 and ultrasonic scalpel 2024. The positions of these recesses 2030 may coincide with the positions of the heavier polymer support pad 2028, which will not be damaged by contact with ultrasonic scalpel 2024. In this way, electrode 2026 can be substantially flush with ultrasonic scalpel 2024 when clamped in a fully clamped state, but without metal-to-metal contact with ultrasonic scalpel 2024. Additional holes defined in the recessed area can be used to heat-fuse or fix the heavy polymer support pad 2028 to the electrode recess 2030. The electrode is adapted and configured for use with a combined ultrasound / RF energy device and is deflectable 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.

[0294] In one aspect, the end effector includes a polyimide front pad. Figures 44 to 45 A clamping arm 2040 according to at least one aspect of the present disclosure is shown, the clamping arm including a clamp 2042 and a stationary gap setting pad 2044 combined with a movable floating gap setting pad 2046. This configuration provides a combined arrangement to generate ultrasonic scalpel pressure while also setting a minimum gap between the electrode 2048 and the ultrasonic scalpel. The electrode 2048 is adapted and configured for use with a combined ultrasonic / RF energy device and is deflectable 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.

[0295] Figure 44 This is a top view of the clamping arm 2040, showing the stationary gap setting pad 2044 and the movable floating gap setting pad 2046. Figure 45 This is a side view of the clamping arm 2040, showing the clamp 2042, the stationary gap setting pad 2044, the movable floating gap setting pad 2046, the electrode 2048, and the clamping arm pad 2050. The stationary pad 2044 on the farthest side 2052 is attached to the clamp 2042 in a similar manner to the clamping arm pad 2050. The stationary gap setting pad 2044 on the farthest side 2052 will improve end pressure / grip and reduce the possibility of short circuit between the electrode 2048 and the ultrasonic scalpel due to burn-through of the stationary gap setting pad 2044.

[0296] Figures 46 to 47 An alternative clamping arm 2060 according to at least one aspect of the present disclosure is shown, the clamping arm including a clamp 2074, a stationary gap setting pad 2064 located at a distal end 2062, a stationary clamping arm pad 2066, and a movable floating gap setting pad 2070 located at a proximal end 2068. The clamping arm 2060 also includes an electrode 2072.

[0297] In one aspect, the end effector includes a deflectable / cantilevered electrode with teeth. Due to the smooth nature of the ultrasonic scalpel, tissue retention within an ultrasonic device can be difficult. Additional gripping features can be added to increase tissue gripping force. 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 the bipolar RF circuit and the ultrasonic scalpel is the opposite pole of the bipolar RF circuit.

[0298] Figures 48 to 49 A combined ultrasonic / bipolar RF energy surgical device employing electrodes including small teeth, according to at least one aspect of this disclosure, is illustrated. Electrode teeth can be added to achieve tissue retention. Teeth passing through the electrodes can be added to clamps. This configuration is relatively easy to implement and provides better tissue retention in ultrasonic devices. In one aspect, this disclosure provides a surgical device comprising an ultrasonic scalpel and an RF electrode for cutting and sealing tissue, wherein the RF electrode is implemented as a flexible member and wherein the flexible electrode includes a plurality of teeth that facilitate tissue grasping. In another aspect, this disclosure provides a surgical device comprising an ultrasonic scalpel and an RF electrode for cutting and sealing tissue, wherein the RF electrode is implemented as a flexible member and wherein a rigid movable clamp includes a plurality of protruding teeth passing through the flexible electrode that facilitate tissue grasping.

[0299] Figure 48 An end effector 2080 according to at least one aspect of the present disclosure is shown, comprising a clamping arm 2082, an ultrasonic scalpel 2084, an electrode 2086 including a plurality of teeth 2088, a flexible clamping arm pad 2090, and hard gap setting pads 2092, 2093. The clamping arm 2082 includes a clamp 2094 capable of pivoting about a pivot point 2096. The electrode 2086 is fixed to the clamp 2094 at a proximal end and freely deflected at a distal end. Thus, throughout the present disclosure, the electrode 2086 may be referred to as a cantilever electrode or a deflectable electrode. The electrode 2086 is adapted and configured for use with a combined ultrasound / bipolar RF energy surgical device and is capable of deflection under load, wherein the electrode 2086 is one pole of a bipolar RF circuit and the ultrasonic scalpel 2084 is the opposite pole of the bipolar RF circuit.

[0300] Figure 49An end effector 2100 according to at least one aspect of the present disclosure is shown, comprising a clamping arm 2102, an ultrasonic scalpel 2104, an electrode 2106, a flexible clamping arm pad 2110, and hard gap setting pads 2112, 2113. The clamping arm 2102 includes a clamp 2114 having teeth 2108 extending through the electrode 2106. The clamp 2114 is pivotally movable about a pivot point. The electrode 2106 is secured to the clamp 2114 at a proximal end and freely deflected at a distal end. Therefore, throughout the present disclosure, the electrode 2106 may be referred to as a cantilever electrode or a deflectable electrode.

[0301] In one aspect, the end effector includes an ultrasonically reloadable electrode subassembly. Figures 50 to 57 A clamping arm 2120 according to at least one aspect of the present disclosure is shown, the clamping arm including a reloadable electrode 2122 coupled with a clamping arm pad 2126 including teeth 2123. The reloadable electrode 2122 provides an advantageous solution to challenges commonly encountered with electrodes, such as wear, tissue buildup, and manufacturing difficulties. The clamping arm 2120 includes a pivot point 2121 that enables the clamping arm 2120 to be pivotally opened and closed. The electrode 2122 is adapted and configured for use with a combined ultrasound / bipolar RF energy surgical device and is capable of deflection under load, wherein the electrode 2122 is one pole of a bipolar RF circuit and the ultrasonic scalpel is the opposite pole of the bipolar RF circuit.

[0302] Figure 50 A reloadable electrode 2122 and a clamping arm pad 2126 according to at least one aspect of the present disclosure are shown. Figure 51 A clamping arm 2120 is shown, comprising a reloadable electrode 2122 located within a clamp 2127 and a clamping arm pad 2126. Hardened, wear-resistant gap pads 2125 and 2129 are disposed on or near the reloadable electrode 2122 to establish a gap between the reloadable electrode 2122 and an ultrasonic scalpel (not shown). The reloadable electrode 2122 includes an arm 2124 formed from a sheet metal extension bent into a spring within the clamping arm 2120 of the end effector. The clamping arm pad 2126 (Teflon, PTFE) can be captured and held within the spring form 2128 of the arm 2124 until it is loaded into the clamping arm 2120. The side portion 2130 of the reloadable electrode 2122 is bent inward to prevent tissue buildup between the clamping arm 2120 and the arm 2124. The reloadable electrode 2122 is secured to the clamp 2127 at the proximal end and freely deflects at the distal end. Therefore, throughout this disclosure, the reloadable electrode 2122 may be referred to as a cantilever beam electrode or a deflectable electrode.

[0303] Figure 52 and Figure 53These are side and top views, respectively, of a reloadable electrode 2122 and a clamping arm pad 2126 being slidably inserted into clamp 2127 from its front (distal end). Arm 2124 is assembled from the front of clamping arm 2120 and held by a curved tab 2132 that positions a slot 2134 within clamp 2127. Tab 2132 can be depressurized to allow replacement of the reloadable electrode 2122 and clamp 2127 during operation. The reloadable electrode 2122 includes a retaining leg 2136 that engages with a recess 2138 in clamping arm 2120. Retaining leg 2136 positions clamping arm 2120 and retains it from release during operation. A slot 2135 defined by clamp 2127 receives the reloadable electrode 2122. The assembly process is less expensive than welding and allows for reuse of the component if defects are found. Other aspects include the orientation of the reloadable electrode 2122 and the clamping arm pad 2126 loaded or reloaded into the clamp 2127, the shape and number of the pads of the clamping arm pad 2126, the configuration of the proximal pad, and the configuration of the electrode holding leg 2136.

[0304] Although the reloadable electrode 2122 is depicted as being loaded from the front (distal end) of the clamp 2127, alternatively, the reloadable electrode 2122 may be loaded from the rear (proximal end), side, or top of the clamp 2127. The shape and number of the clamping arm pads 2126 can be varied to suit a specific clinical task. In this respect, the proximal clamping arm pad 2126 is located on the clamping arm 2120. In terms of replaceability, the proximal clamping arm pad 2126 can be attached to the reloading side. The number and size of the electrode retaining legs 2136 can be varied. Another retaining feature besides the electrode retaining legs 2136 may be used.

[0305] Figure 54 It is a cross-sectional view of the electrode support 2136 in the recess 2138 of the insertion clamp 2127 and the curved tab 2132 located in the groove 2134 defined by the clamp 2127, and Figure 55 This is a detailed view of the clamping arm recess 2138. Figure 56 This demonstrates how to release arm 2124 by pressing the bending tab 2132. Figure 57 This is a detailed view of the reloadable electrode 2122 and arm 2124 formed as a stamping component, showing the extension of the metal sheet and the orifice 2142 sized and configured to receive the tooth 2123 protruding from the clamping arm pad 2126, the orifice 2144 sized and configured to receive the hard wear-resistant gap pad 2125, and the orifice 2146 sized and configured to receive the hard wear-resistant gap pad 2129.

[0306] The reloadable electrode 2122 offers several advantages and benefits, including preventing short circuits between the reloadable electrode 2122 and the ultrasonic scalpel 2104, overcoming insufficient tissue pressure due to wear of the polymer (e.g., Teflon, PTFE) clamping arm pad 2126, improving end gripping, reducing tissue tangles and adhesions, reducing tissue buildup between the replaceable electrode 2124 and the clamping arm 2120, preventing delamination between the replaceable electrode 2124 and the clamping arm 2120, improving manufacturability, and / or improving reliability / lifespan.

[0307] In one aspect, the end effector includes a supplementary pad configuration. This disclosure provides an end effector configured for use with a combined ultrasound / bipolar (RF) electrosurgical instrument. The end effector maintains a consistent gap between the bipolar RF electrode of the combined ultrasound / bipolar RF energy device and an ultrasonic scalpel, wherein the ultrasonic scalpel is one pole of the bipolar RF circuit and the clamping arm is the opposite pole of the bipolar RF circuit. In conventional end effector configurations, the gap between the bipolar RF electrode and the ultrasonic scalpel is set by a soft polymer (e.g., PTFE) clamping arm pad subjected to wear during surgical procedures. When the polymer pad wears through, there is a risk that the ultrasonic scalpel may come into contact with the electrode, resulting in interruption of ultrasound or a short circuit between the electrode and the ultrasonic scalpel. The electrode is adapted and configured for use with a combined ultrasound / bipolar RF energy surgical device and is capable of deflection under load, wherein the electrode is one pole of the bipolar RF circuit and the ultrasonic scalpel is the opposite pole of the bipolar RF circuit.

[0308] In one aspect, this disclosure provides an end effector incorporating an RF electrode fixed to a clamping arm. The electrode includes a wear-resistant, non-conductive pad that contacts the ultrasonic scalpel to set a scalpel-electrode gap. These wear-resistant gap-setting pads also respond to clamping forces applied to the ultrasonic scalpel. The electrode defines a series of orifices through which a flexible polymer (Teflon / PTFE) clamping arm pad protrudes and contacts the ultrasonic scalpel in the clamped position. The flexible polymer clamping arm pad is supported by a spring element positioned between the clamping arm pad and the clamping arm. The spring element maintains consistent contact between the clamping arm pad and the ultrasonic scalpel. As the flexible polymer clamping arm pad wears, more material is pushed through the electrode by the spring to maintain the clamping arm pad in ultrasonic scalpel contact throughout the lifespan of the combined ultrasonic / bipolar RF energy device. The spring can be a compression spring, a leaf spring, or an elastomer, or other types of springs.

[0309] Figures 58 to 60 An end effector 2150 comprising an ultrasonic scalpel 2152 and a clamping arm 2154 according to at least one aspect of the present disclosure is shown, the clamping arm including a spring-loaded clamping arm pad 2156. Figure 58 This is a perspective view of the end effector. Figure 59 This is a cross-sectional view of the end effector 2150, and Figure 60This is an exploded view of the end effector 2150. The clamping arm 2154 also includes a clamp 2158 and a clamping arm pad tooth 2155 assembly, the clamp being sized and configured to receive an aperture 2160 of the electrode 2162 therein. The electrode 2162 is also sized and configured to receive an aperture 2164 of the clamping arm pad tooth 2155 passing through it. A plurality of springs 2168 are located in corresponding bosses 2170. A backplate 2172 locks to the clamp 2158 and compresses the springs 2168 to apply a load to the clamping arm pad 2155. The load applied to the clamping arm pad 2155 causes the spring-loaded clamping arm pad 2156 to remain in contact with the ultrasonic scalpel 2152 as the spring-loaded clamping arm pad 2156 wears during use. Electrode 2162 is adapted and configured for use with a combined ultrasound / bipolar RF energy surgical device and is deflectable under load, wherein electrode 2162 is one pole of the bipolar RF circuit and ultrasonic scalpel 2152 is the opposite pole of the bipolar RF circuit.

[0310] Figure 61 A spring-loaded clamping arm pad 2180 according to at least one aspect of the present disclosure is shown. The clamping arm pad 2180 includes a clamp 2182, an electrode 2184, a flexible clamping arm pad 2186 (e.g., PTFE), and a hard gap setting pad 2188 (e.g., polyimide). A spring force is applied to the clamping arm pad 2186 to move the clamping arm pad 2186 relative to the electrode 2184 while the electrode 2184 remains fixed.

[0311] Figure 62 A clamping arm 2190, comprising a spring-loaded clamping arm pad 2192, is shown according to at least one aspect of the present disclosure. The clamping arm 2190 also includes a back plate 2194 and a plurality of springs 2196 located between a clamp 2198 and the back plate 2200. The base of the clamping arm pad 2192 is fixed to the back plate 2194, and protrusions 2202 (e.g., teeth) of the clamping arm pad 2192 extend through an aperture 2204 defined by an electrode 2206. In one aspect, the clamping arm 2190 further includes a plurality of gap-setting pads 2208 made of a hard, abrasion-resistant material to set a gap between the electrode 2206 and an ultrasonic scalpel (not shown). In one aspect, the spring-loaded clamping arm pad 2192 is made of a lubricated, non-stick, flexible material such as PTFE, and the gap-setting pads 2208 are made of a harder, abrasion-resistant material such as polyimide.

[0312] Figure 63A clamping arm 2210 according to at least one aspect of the present disclosure is shown, comprising a spring-loaded clamping arm pad 2212, an electrode 2214, and a gap setting pad 2216. A cutout 2218 in the clamping arm pad 2212 defines a protrusion 2215 serving as a spring element. The base of the clamping arm pad 2212 is fixed to the back of the electrode 2214, and a protrusion 2211 (e.g., a tooth) of the clamping arm pad 2212 extends through an aperture 2213 defined by the electrode 2214. In one aspect, the spring-loaded clamping arm pad 2212 is made of a lubricated, non-stick, flexible material such as PTFE, and the gap setting pad 2216 is made of a harder, abrasion-resistant material such as polyimide.

[0313] Figure 64 A clamping arm 2220 according to at least one aspect of the present disclosure is shown, comprising a spring-loaded clamping arm pad 2222 uniformly raised by an elastomeric spring 2224. The elastomeric spring 2224 may be formed of rubber, foam, or other elastic material. The elastomeric spring 2224 is positioned above a rigid plastic gap setting pad 2226. In one aspect, the spring-loaded clamping arm pad 2222 is made of a lubricated, non-stick, flexible material such as PTFE, and the gap setting pad 2226 is made of a harder, abrasion-resistant material such as polyimide.

[0314] Figure 65 A clamping arm 2230 comprising a spring-loaded clamping arm pad 2232 is shown according to at least one aspect of the present disclosure. A spring 2234 applies a load to the clamping arm pad 2232 such that the clamping arm pad 2232 maintains close contact with the ultrasonic scalpel during surgical procedures.

[0315] In one aspect, the end effector includes a floating gripper arm pad. Figures 66 to 82 An end effector 2240 according to at least one aspect of the present disclosure is shown, the end effector including a first configuration and a second configuration of floating clamping arms 2242, 2244 combined with an ultrasonic scalpel 2246. The configuration of the end effector 2240 includes clamping arm pad units 2248, 2250 supported by elastic / hyperelastic blocks 2252, 2254 and an electrode 2255 for use in combination with the ultrasonic scalpel 2246 to reduce wear on the clamping arm pad units 2248, 2250 and increase cutting speed at locations with higher tissue volumes. The elastic / hyperelastic blocks 2252, 2254 may be formed as a single piece or multiple individual pieces 2250. Individual clamping arm pad units 2248, 2250 may be biased against the elastic / hyperelastic block 2254 to accommodate a high-pressure region between the floating clamping arm 2244 and the ultrasonic scalpel 2246. Electrode 2255 is adapted and configured for use with a combined ultrasound / bipolar RF energy surgical device and is deflectable under load, wherein electrode 2255 is one pole of the bipolar RF circuit and ultrasonic scalpel 2246 is the opposite pole of the bipolar RF circuit.

[0316] In one aspect, the floating gripping arms 2242, 2244 include a plurality of individual gripping arm pad units 2248, 2250, each of the individual gripping arm pad units 2248, 2250 being seated abutting against a single-piece block 2252 or multiple-piece block 2254 attached to the floating gripping arms 2242, 2244. Each of the individual gripping arm pad units 2248, 2250 includes a collar 2264 to restrict movement of the individual gripping arm pad unit 2248, 2250 along a channel of electrode 2255 and between the clamp 2260 and electrode 2255. The single-piece block 2252 or multiple-piece block 2254 is made of an elastic or hyperelastic material to provide spring-like properties for balancing pressure between the sides of the floating gripping arms 2242, 2244 and the sides of the ultrasonic scalpel 2246. The material may be porous, rubber, or a similar electrically insulating material. Compressible blocks 2252 and 2254 enable the individual clamping arm pad units 2248 and 2250 to float. At locations with higher tissue volume, blocks 2252 and 2254 are pushed to be compressed by the individual clamping arm pad units 2248 and 2250, thereby inducing higher pressure on the tissue to increase the cutting speed in that area and enhance hemostasis. The compressed blocks 2252 and 2254 continue to push the individual clamping arm pad units 2248 and 2250 back against the tissue until the tissue is completely cut.

[0317] Figure 67 This is an exploded view of the clamp 2260, electrode 2255, and ultrasonic scalpel 2246 components, which are common to either the first or second configuration of the floating clamping arms 2242 and 2244.

[0318] Figure 68 The diagram shows a first configuration of the floating gripping arm 2242, including a gripping arm pad unit 2248 and a one-piece elastic / hyperelastic block 2252 component. The one-piece elastic / hyperelastic block 2252 supports the gripping arm pad unit 2248 and may be made of a porous, rubber, or similar electrically insulating material.

[0319] Figure 69 A second configuration of the floating gripping arm 2244 is shown, comprising a gripping arm pad unit 2250 and a multi-piece elastic / hyperelastic block 2254 component. Each of the multi-piece elastic / hyperelastic blocks 2254 supports each of the gripping arm pad units 2250 and may be made of a porous, rubber, or similar electrically insulating material. Each of the multi-piece elastic / hyperelastic blocks 2254 is coupled to each individual gripping arm pad unit 2250. Each of these configurations will be described in more detail below.

[0320] Figure 70A layout of clamping arm pad units 2250 protruding through an aperture 2262 defined by electrodes 2255 but not in contact with each other, according to at least one aspect of the present disclosure, is shown.

[0321] Figure 71 An aperture 2262, defined by electrode 2255 and configured to receive any of the clamping arm pad units 2248, 2250, is shown. The aperture 2262 defines a channel 2266 to guide movement of the individual clamping arm pad units 2248, 2250. A collar 2264 on each individual clamping arm pad unit 2248, 2250 constrains movement between the floating clamping arms 2242, 2244 and electrode 2255, and prevents the individual clamping arm pad units 2248, 2250 from escaping from electrode 2255.

[0322] Figure 72 It is an assembly diagram of the first configuration clamping arm 2248, including the single-piece elastic / hyperelastic block 2252. Figure 73 This is a cross-sectional view of a first configuration of an end effector 2270 including a floating gripping arm 2242 and an ultrasonic scalpel 2246 according to at least one aspect of this disclosure. The floating gripping arm 2242 includes a clamp 2260 and a plurality of individual gripping arm pad units 2248 positioned through an orifice 2262 defined by an electrode 2255 and supported by a one-piece elastic / hyperelastic block 2252. The plurality of individual gripping arm pad units 2248 engage tissue 2268 located between the ultrasonic scalpel 2246 and the electrode 2255.

[0323] Figure 74 This is a cross-sectional view of a second configuration of an end effector 2280 including a floating clamping arm 2244 and an ultrasonic scalpel 2246 according to at least one aspect of this disclosure. The floating clamping arm 2244 includes a clamp 2261 and a plurality of individual clamping arm pad units 2250 positioned through an orifice 2262 defined by an electrode 2255 and supported by a multi-piece elastic / hyperelastic block 2254. The plurality of individual clamping arm pad units 2250 engage tissue 2268 located between the ultrasonic scalpel 2246 and the electrode 2255.

[0324] Figure 75A method 2290 is shown for assembling a first-configuration end effector 2292 comprising a floating gripping arm 2242 and an ultrasonic scalpel 2246 according to at least one aspect of this disclosure. The first sub-assembly 2296 includes a single gripping arm pad unit 2248 assembled to an electrode 2255. The second sub-assembly 2298 includes a one-piece elastic / hyperelastic block 2252 assembled to a clamp 2260 by welding or screwing. A third sub-assembly 2300 includes the first sub-assembly 2296 assembled to the second sub-assembly 2298 to obtain a fully assembled floating gripping arm 2242. The end effector 2292 is completed by adding the ultrasonic scalpel 2246 to the third sub-assembly 2300.

[0325] Figure 76 It shows that according to Figure 75 Assembled end effector 2292. (e.g.) Figure 77 As shown, at a higher position in the volume of tissue 2268, the one-piece elastic / hyperelastic block 2252 is compressed by a single clamping arm pad unit 2248, thereby causing higher pressure on tissue 2268 to increase the cutting speed in that area, which may enhance hemostasis. The compressed one-piece elastic / hyperelastic block 2252 continues to press against tissue 2268, pushing the single clamping arm pad unit 2248, until tissue 2268 is completely cut, and the single clamping arm pad unit 2248 returns to its initial position.

[0326] Figure 78 Position 2249 is shown, where a one-piece elastic / hyperelastic block 2252 balances the pressure between the ultrasonic scalpel 2246 and the individual clamping arm pad unit 2248 when the ultrasonic scalpel 2246 is in direct contact with the individual clamping arm pad unit 2248, thereby reducing wear on the individual clamping arm pad unit 2248.

[0327] Figure 79 A method 2310 is shown for assembling a second configuration end effector 2312, including a floating gripping arm 2244 and an ultrasonic scalpel 2246, according to at least one aspect of this disclosure. A first sub-assembly 2316 includes a single gripping arm pad unit 2250 and a multi-piece elastic / hyperelastic block 2254 assembled to an electrode 2255. A second sub-assembly 2318 includes the first sub-assembly 2316 assembled to a clamp 2260 by any suitable fastening technique, such as welding, laser welding, brazing, soldering, pressing, and other fastening techniques such as screws. The end effector 2312 is completed by adding the ultrasonic scalpel 2246 to the second sub-assembly 2318.

[0328] Figure 80 It shows that according to Figure 79 Assembled end effector 2312. For example... Figure 81As shown, at a higher position in the volume of tissue 2268, the multi-piece elastic / hyperelastic block 2254 is pushed to be compressed by the individual clamping arm pad unit 2250, thereby causing higher pressure on the tissue 2268 to increase the cutting speed in that area, which may enhance hemostasis. The compressed multi-piece elastic / hyperelastic block 2254 continues to press against the tissue 2268, pushing the individual clamping arm pad unit 2250, until the tissue 2268 is completely cut, and the individual clamping arm pad unit 2250 returns to its initial position.

[0329] Figure 82 Position 2251 is shown, where, when the ultrasonic scalpel 2246 directly contacts the individual clamping arm pad unit 2250, the multi-piece elastic / hyperelastic block 2254 can balance the pressure between the ultrasonic scalpel 2246 and the individual clamping arm pad unit 2250, thereby reducing wear on the individual clamping arm pad unit 2250.

[0330] In one aspect, the end effector includes selectively deployable teeth. In combined ultrasound / bipolar RF energy devices, selectively deployable teeth may be desirable to facilitate different energy modes. This enables versatility without significant configurational trade-offs. In a retracted configuration, the ultrasound pad teeth provide increased surface area contact between tissue and electrode and are ideal for sealing tissue for applying a single RF energy mode. In a fully deployed configuration, the ultrasound pad teeth provide low-risk metal-to-metal contact between the ultrasonic scalpel and electrode and are ideal for tissue manipulation and applying a single ultrasound energy mode. In a partially deployed configuration, the ultrasound pad teeth are well-suited for simultaneously applying ultrasound and RF energy modes. The electrode is adapted and configured for use with a combined ultrasound / bipolar RF energy surgical device and is deflectable under load, wherein the electrode is one pole of the bipolar RF circuit and the ultrasonic scalpel is the opposite pole of the bipolar RF circuit.

[0331] Figure 83 A clamping arm 2320 according to at least one aspect of the present disclosure is shown, comprising selectively deployable pad teeth 2330. The clamping arm 2320 includes clamps 2322, electrodes 2324, a plurality of orifices 2326 defined by the electrodes 2324, and a drive tab 2328. The plurality of orifices 2326 defined by the electrodes 2324 include deployable pad teeth 2330. The drive tab 2328 is used to deploy or retract the deployable pad teeth 2330, such that the deployable pad teeth 2330 retract when the drive tab 2328 retracts and deploys when the drive tab 2328 advances. Alternatively, this configuration can be reversed, such that the deployable pad teeth 2330 deploy when the drive tab 2328 retracts and retracts when the drive tab 2328 advances. In one respect, the toothed plug 2330 is made of a lubricating flexible polymer material such as Teflon / PTFE.

[0332] Similar to a nail cylinder, the clamping arm 2320 assembly is formed by nesting a drive tab 2328 into a channel of the clamp 2322. Selectably deployable pad teeth 2330 are positioned within the actuator 2332. Figures 84 to 85 The electrode 2324 is located on the clamp 2322 and is situated within the subassembly by interfering with the electrode 2324. To complete the subassembly, the electrode 2324 can be securely attached to the clamp 2322 using any suitable fastening technique, such as welding, laser welding, brazing, soldering, pressing, and other fastening techniques. Within the clamp 2322, the translation actuator 2332 causes the selectively unfolded pad teeth 2330 to rise or fall relative to the surface of the electrode 2324.

[0333] Figure 84 It is based on at least one aspect of this disclosure Figure 83 The figure shows a cross-sectional view of a clamping arm 2320, which includes selectively deployable pad teeth 2330 positioned in a retracted configuration within an aperture 2236. As the actuator 2332 retracts toward the proximal side 2334, the selectively deployable pad teeth 2330 retract below the electrode 2324, as shown.

[0334] Figure 85 It is based on at least one aspect of this disclosure Figure 83 The figure shows a cross-sectional view of a clamping arm 2320, which includes selectively deployable pad teeth 2330 in an deployed configuration. As the actuator 2332 advances toward the distal side 2336, the selectively deployable pad teeth 2330 deploy above the electrode 2324, as shown.

[0335] Figure 86 It is based on at least one aspect of this disclosure Figure 83 A detailed cross-sectional view of the clamping arm 2320 shown is included, which comprises selectively deployable pad teeth 2330 in a retracted configuration. Each of the selectively deployable pad teeth 2330 has a shoulder 2338 larger than the orifice 2326 defined by electrode 2324 to retain the selectively deployable pad tooth 2330 within the clamp 2322. The geometry 2340 of the selectively deployable pad teeth 2330 is sized and configured to deploy through the orifice 2326. The interference geometry 2342 may be circular (as shown), angled, or a combination thereof to optimize the desired force profile for deploying the selectively deployable pad teeth 2330. Additional handle mechanisms (push / pull levers, additional tube drives) known in the art may be used to actuate the actuator 2332.

[0336] In one aspect, the end effector includes a clamping arm pad with a heat dissipation and cooling mechanism. In another aspect, the clamping arm pad includes a heat sink to protect the clamping arm pad of the ultrasound device by reducing heat buildup on the clamping arm pad. Various techniques can be used to reduce heat buildup on the clamping arm pad. The electrode is adapted and configured for use with a combined ultrasound / bipolar RF energy surgical device and is capable of deflection under load, wherein the electrode is one pole of the bipolar RF circuit and the ultrasonic scalpel is the opposite pole of the bipolar RF circuit.

[0337] Figure 87A The illustration shows that at least one aspect of the present disclosure is configured to accept such Figures 87B to 87C The end effector 2350 of the heat dissipation material block 2356 shown. The end effector 2350 includes a clamp 2352 and an ultrasonic scalpel 2354. Figure 87B It shows Figure 87A An example of the end effector 2350 shown is wherein a heat dissipation material block 2356 is added to or otherwise fixedly attached to a clamping arm pad 2358 supported by a metal clamp 2352. Figure 87C A heat dissipation material block 2356 with worn clamping arm pad 2359 is shown. The heat dissipation material block 2356 reduces heat buildup and will protect the clamping arm pad 2359 from overheating due to contact with the ultrasonic scalpel 2354.

[0338] Figure 88A An end effector 2360 comprising a metal clamp 2362 and an ultrasonic scalpel 2364 according to at least one aspect of the present disclosure is shown, wherein at least some portions of the metal clamp are made of a heat-dissipating material. In one aspect, the entire metal clamp 2362 is made of a heat-dissipating material and is tightly secured to... Figure 88B The clamping arm pad 2366 shown in the figure and Figure 88C The alternative clamping arm pad 2368 is shown in the figure. The heat dissipation material may include any one or both of materials having high thermal conductivity and high specific heat, and form a large surface area feature to enhance heat diffusion as heat accumulates in the clamping arm pads 2366, 2368 due to contact with the ultrasonic scalpel 2364.

[0339] Combination Figures 87A to 87C For components 88A to 88C, the heat dissipation material should have high thermal conductivity, such as aluminum, copper, their alloys, or other similar materials. Furthermore, the heat dissipation material forms a large surface area on the heat dissipation component to accelerate heat diffusion or dissipation. The most common heat dissipation material is aluminum alloy. Aluminum alloy 1050 has a relatively high thermal conductivity of 229 W / m·K, but is mechanically soft. Aluminum alloys 6060 (low stress), 6061, and 6063 can be used, with thermal conductivity values ​​of 166 W / m·K and 201 W / m·K, respectively.

[0340] Figure 89 It shows Figures 87A to 87C and 88A to Figure 88C The components 2350 and 2360 of the end effector described herein.

[0341] Figure 90 A heat dissipation structure 2367 is shown that includes fins 2369 for increasing the surface area of ​​a heat sink component, according to at least one aspect of the present disclosure.

[0342] Figure 91 Another heat dissipation structure 2370 according to at least one aspect of the present disclosure is shown, including holes 2372 for increasing the surface area of ​​the heat sink component.

[0343] In various aspects, this disclosure provides combined ultrasound / bipolar RF energy surgical devices and systems. Various forms relate to user interfaces for surgical instruments having ultrasound and / or electrosurgical (RF) end effectors configured to perform tissue treatment, dissection, cutting, and / or coagulation during surgical procedures. In one form, a user interface is provided for a combined ultrasound and electrosurgical instrument that can be configured for open surgical procedures but also for other types of surgical procedures, such as minimally invasive laparoscopic, visual, or thoracic procedures, such as non-invasive endoscopic procedures in handheld or robot-assisted procedures. Versatility is achieved by selectively applying multiple energy modalities simultaneously, independently, sequentially, or in combination thereof. For example, versatility can be achieved by selectively using ultrasound and electrosurgical energy (e.g., monopolar or bipolar RF energy) simultaneously, independently, sequentially, or in combination thereof.

[0344] In one aspect, this disclosure provides a user interface for a device including an ultrasonic scalpel and a clamping arm with deflectable RF electrodes, such that the ultrasonic scalpel and the deflectable RF electrodes cooperate to perform tissue sealing, cutting, and clamping through the cooperation of a clamping mechanism of the device including the RF electrodes and the associated ultrasonic scalpel. The clamping mechanism includes a pivoting clamping arm that cooperates with the ultrasonic scalpel to grasp tissue therebetween. The clamping arm preferably has a tissue-holding pad (also referred to as a "clamping arm pad") having a plurality of axially spaced clamping teeth, segments, elements, or individual units that cooperate with the ultrasonic scalpel of the end effector to achieve desired sealing and cutting effects on the tissue, while facilitating tissue grasping and clamping during surgical procedures.

[0345] In one aspect, the end effector described herein includes electrodes. In other aspects, the end effector described herein includes alternative forms of electrodes to provide a flexible connection of RF energy to tissue, accommodate pad wear / thinning, minimize the generation of excessive heat (low coefficient of friction, pressure), minimize spark generation, minimize interruptions due to electrical short circuits, or combinations thereof. The electrodes are secured to the clamp at a proximal end and freely deflect at a distal end. Thus, throughout this disclosure, the electrodes may be referred to as cantilever beam electrodes or deflectable electrodes.

[0346] In other respects, the end effector described herein includes a clamping arm mechanism configured to apply high pressure between the pad and the ultrasonic scalpel to grip and seal tissue, maximizing the likelihood of the clamping arm electrode contacting tissue in confined or difficult scenarios such as, for example, thin tissue, tissue under lateral tension, tissue bulging / vertical tension, especially when bulging tissue is far from the clamping arm.

[0347] In other respects, the end effector described herein is configured to balance the surface area / current density matching between electrodes, balance and minimize thermal conduction from tissue interfaces, such as those affecting damage formation and symmetry, cycle time, and residual heat. In other respects, the end effector described herein is configured to minimize adhesion, tissue adhesion (minimize anchoring points), and may include small polyimide pads.

[0348] In various aspects, this disclosure provides a surgical device configured to deliver at least two types of energy (e.g., ultrasound, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue. The surgical device includes a first activation push-button switch for activating the energy and a second push-button switch for selecting an energy mode for activating the push-button switch. The second push-button switch is connected to circuitry that defines the energy mode using at least one input parameter. The input parameter can be modified remotely via a connection to a generator or via a software update.

[0349] In one aspect, at least one energy mode in the energy mode is a simultaneous mixture of RF energy and ultrasonic energy, and the input parameters represent the duty cycle of the RF energy and the ultrasonic energy.

[0350] In one aspect, the second button switch can be configured to be able to select from a predefined list of modes, and the number of modes in the list is defined by a user-defined second input parameter.

[0351] In one respect, the input parameters are duty cycle, voltage, frequency, pulse width, or current.

[0352] In one aspect, the device also includes a visual indicator of the selected energy mode within the surgical field.

[0353] In one respect, the second push-button switch is a controller separate from the end actuator closing trigger.

[0354] In one aspect, the second push-button switch is configured to actuate the second stage of the closing trigger. The first stage of the closing trigger in the closing direction actuates the end effector.

[0355] In one aspect, at least one energy mode is selected from ultrasound, RF bipolar, RF monopolar, microwave, or IRE.

[0356] In one aspect, at least one of the energy modes is selected from ultrasound, RF bipolar, RF monopolar, microwave, or IRE and is configured to be applied with a predefined duty cycle or pulse algorithm.

[0357] In one aspect, at least one energy mode is selected from two or more of the following types of energy applied in sequence: ultrasound, RF bipolar, RF monopolar, microwave, or IRE.

[0358] In one respect, at least one energy mode in the energy mode is a simultaneous mixture of two or more of the following types of energy: ultrasound, RF bipolar, RF monopolar, microwave, and IRE.

[0359] In one aspect, at least one energy mode in the energy mode is a simultaneous mixture 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 aforementioned energies.

[0360] 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, and then a simultaneous mixture of two or more of the above energies.

[0361] In one respect, at least one energy mode in the energy pattern is a predefined algorithm specific to a procedure or organization.

[0362] In one respect, at least one energy pattern in the energy pattern is compiled from the learned surgical behavior or activity.

[0363] In one respect, 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.

[0364] In one aspect, the second button switch can be configured 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 user-defined second input parameter.

[0365] In one respect, the aforementioned energy modes can be made available to users through a software update of the generator.

[0366] In one respect, the aforementioned energy modes can be made available to users through software updates to the device.

[0367] In one aspect, multiple generators are available to users through network, cloud, or manual transmission, allowing for preferred options.

[0368] In one aspect, the device also includes a visual indicator of the selected energy mode within the surgical field.

[0369] As used herein, a push-button switch can be a manually, mechanical, or electrically operated electromechanical device having 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 in contact and electricity can flow between them, or "open," meaning the contacts are separated and the switch is not conductive. The mechanism that actuates to switch between these two states (open or closed) can be of the "alternating action" (toggling the switch to continuous "on" or "off") or "momentary" (pushing for "on" and releasing for "off") type.

[0370] In one aspect, this disclosure provides a combined ultrasound / 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 dedicated modes for operating them increases. Adding additional push-button switches to accommodate these new additional modes would complicate the user interface and make the device more difficult to use. Therefore, this disclosure provides techniques for assigning different modes to a single physical push-button switch, which enables more mode selection without increasing the complexity of the housing design (e.g., without adding more and more push-button switches). In one aspect, the housing is in the form of a handle or pistol grip.

[0371] As more specialized modes become available, there is a need to provide surgeons using surgical devices with multiple modes without creating a complex user interface. Surgeons want to be able to select modes from within a sterile area, rather than relying on a circulating nurse at the generator. Surgeons also want real-time feedback so they have confidence in which mode to choose.

[0372] Figure 92A surgical device 100 according to at least one aspect of the present disclosure is shown, the device including a mode selection push-button switch 130. The surgical device 100 includes a housing 102 defining a handle 104 in the form of a pistol grip. The housing 102 includes a trigger 106, which, when squeezed, is received in an internal space defined by the handle 104. The trigger 106 is used to actuate a clamping arm 111 portion of an end effector 110. The clamp 112 is pivotally movable about a pivot point 114. The housing 102 is coupled to the end effector 110 via a shaft 108 rotatable by a knob 122.

[0373] The end effector 110 includes a clamping arm 111 and an ultrasonic scalpel 116. The clamping arm 111 includes a clamp 112, an electrode 118, and a clamping arm pad 120. In one aspect, the clamping arm pad 120 is made of a non-stick lubricating material, such as PTFE or similar tetrafluoroethylene synthetic fluoropolymers. PTFE is a hydrophobic, non-wetting, high-density, and high-temperature resistant multi-purpose material with non-stick properties. The clamping 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). Electrode 118 may include a gap setting pad made of a polyimide material, and in one aspect be 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 (polyetheretherketone), or PEKK (polyetherketoneketone) polymer alloy. Unless otherwise stated below, the clamping arm pad and gap pad described below are made of the materials described in this paragraph.

[0374] Electrode 118 and ultrasonic scalpel 116 are coupled to generator 133. Generator 133 is configured to drive RF, microwave, or IRE energy to electrode 118. Generator 133 is also configured to drive an ultrasonic transducer acoustically coupled to ultrasonic scalpel 116. In some embodiments, electrode 118 is one pole of a circuit and ultrasonic scalpel 116 is the opposite pole of that circuit. Housing 102 includes switch 124 to actuate ultrasonic scalpel 116. The circuitry may be housed in housing 102 or may reside in generator 133. Surgical device 100 is coupled to generator 133 via cable 131. Cable 131 conducts signals for electrosurgical functions and the ultrasonic transducer.

[0375] In various aspects, the surgical device 100 is configured to deliver at least two types of energy (e.g., ultrasound, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue in an end effector 110 located between a gripping arm 111 and an ultrasonic scalpel 116. The housing 102 of the surgical device 100 includes a first activation push-button switch 126 for activating the energy and a second “mode” push-button switch 130 for selecting an energy mode for activating the push-button switch. The second push-button switch 130 is connected to circuitry that defines the energy mode using at least one input parameter. The input parameter can be modified remotely via a connection to a generator or via a software update. The energy mode is displayed on a user interface 128.

[0376] In one aspect, the surgical instrument 100 provides mode switching via a direction selector "mode" button switch 130 on the device. 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.

[0377] According to various aspects of this disclosure, different operating modes can be assigned to the surgical device by pressing the "mode" button switch 130, wherein each time the mode button switch 130 is pressed or pushed and held, the surgical device 100 switches between available modes displayed on the user interface 128. Once a mode is selected, the generator 133 will provide an appropriate generator tone, and the surgical device 100 will have an illuminated indicator on the user interface 128 to indicate which mode has been selected.

[0378] exist Figure 92 In the example shown, the "mode" selection button switch 130 is symmetrically positioned on both sides of the housing 102. This allows both right-handed and left-handed surgeons to select / switch modes without using a second hand. In this respect, the "mode" selection button switch 130 can be switched in many different directions, allowing the surgeon to select from a list of options and remotely navigate to more complex selections from the sterile area without requiring the circulating staff to adjust it at the generator 133. In addition to the tone of the generator 133, an illuminated indicator on the user interface 128 of the surgical device 100 also provides feedback to the surgeon regarding which mode has been selected.

[0379] Figures 93A to 93C Three options for selecting various operating modes of the surgical device 100 according to at least one aspect of this disclosure are shown. 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, on which the generator 133 announces the selected mode by voice and / or displays a description of the selected mode on the screen of the generator 133.

[0380] Figure 93A A first mode selection option 132A is shown, wherein a button switch 130 can be pressed forward 136 or backward 134 to cycle the surgical instrument 100 between various modes.

[0381] Figure 93B The second mode selection option 132B is shown, wherein pressing the button switch 130 up 140 or down 138 causes the surgical instrument 100 to cycle between various modes.

[0382] Figure 93C A third mode selection option 132C is shown, in which the button switch 130 is pressed forward 136, backward 134, up 149, or down 138 to cycle the surgical instrument 100 between various modes.

[0383] Figure 94 A surgical device 150 according to at least one aspect of the present disclosure is shown, the device including a mode selection button switch 180 on its rear side. The surgical device 150 includes a housing 152 defining a handle 154 in the form of a pistol grip. The housing 152 includes a trigger 156, which, when squeezed, is received in an internal space defined by the handle 154. The trigger 156 is used to operate a clamping arm 161 portion of an end effector 160. The clamp 162 is pivotally movable about a pivot point 164. The housing 152 is coupled to the end effector 160 via a shaft 158 ​​rotatable by a knob 172.

[0384] The end effector 160 includes a clamping arm 161 and an ultrasonic scalpel 166. The clamping arm 161 includes a clamp 162, an electrode 168, and a clamping arm pad 170. In one aspect, the clamping arm pad 170 is made of a non-stick lubricating material, such as PTFE or similar tetrafluoroethylene synthetic fluoropolymers. PTFE is a hydrophobic, non-wetting, high-density, and high-temperature resistant multi-purpose material with non-stick properties. The clamping 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). Electrode 168 may include a gap setting pad made of a polyimide material, and in one aspect 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 (polyetheretherketone), or PEKK (polyetherketoneketone) polymer alloy. Unless otherwise stated below, the clamping arm pad and gap pad described below are made of the materials described in this paragraph.

[0385] Electrode 168 and ultrasonic scalpel 166 are coupled to generator 133. Generator 133 is configured to drive RF, microwave, or IRE energy to electrode 168. Generator 133 is also configured to drive an ultrasonic transducer acoustically coupled to ultrasonic scalpel 166. In some embodiments, electrode 168 is one pole of a circuit and ultrasonic scalpel 166 is the opposite pole of that circuit. Housing 152 includes switch 174 to actuate ultrasonic scalpel 166. The circuitry may be housed in housing 152 or may reside in generator 133. Surgical device 150 is coupled to generator 133 via cable 181. Cable 181 conducts signals for electrosurgical functions and the ultrasonic transducer.

[0386] In various aspects, the surgical device 100 is configured to deliver at least two types of energy (e.g., ultrasound, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue in an end effector 110 located between a gripping arm 111 and an ultrasonic scalpel 116. The housing 102 of the surgical device 100 includes a first activation push-button switch 126 for activating the energy and a second “mode” push-button switch 130 for selecting an energy mode for activating the push-button switch. The second push-button switch 130 is connected to circuitry that defines the energy mode using at least one input parameter. The input parameter can be modified remotely via a connection to a generator or via a software update. The energy mode is displayed on a user interface 128.

[0387] In one aspect, the surgical instrument 150 provides mode switching via a direction selector "mode" button switch 180 on the device. 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.

[0388] According to various aspects of this disclosure, different operating modes can be assigned to the surgical device by pressing a “mode” button switch 180, wherein each time the mode button switch 180 is pressed or pushed and held, the surgical device 150 switches between available modes displayed on the user interface 178. Once a mode is selected, the generator 133 will provide an appropriate generator tone, and the surgical device 150 will have an illuminated indicator on the user interface 178 to indicate which mode has been selected.

[0389] exist Figure 94In the example shown, the "mode" selection button switch 180 is located on the back of the housing 150. The position of the "mode" selection button switch 180 is beyond the reach of the surgeon's hand holding the surgical device 150, thus requiring a second hand to change the mode. This is designed to prevent accidental activation. To change the mode, the surgeon must intentionally press the mode button switch 180 using their second hand. In addition to the tone of the generator, an illuminated indicator on the user interface 178 of the surgical device 150 also provides feedback to the surgeon regarding which mode has been selected.

[0390] Figure 95A The first mode selection option is shown, wherein as the mode button switch 180 is pressed to switch between various modes, a colored light indicates the selected mode on the user interface 178.

[0391] Figure 95B A second mode selection option is shown, wherein as the mode button switch 180 is pressed to switch between various modes, the screen 182 indicates the selected mode (e.g., LCD, e-ink).

[0392] Figure 95C A third mode selection option is shown, wherein a marked light 184 indicates the selected mode as the mode button switch 180 is pressed to switch between various modes.

[0393] Figure 95D A fourth mode selection option is shown, wherein when the marked button switch 186 is pressed to select a mode, the marked button switch 180 is illuminated to indicate the selected mode.

[0394] In one aspect, this disclosure provides a combined ultrasound / bipolar RF energy surgical device that includes energy activation via trigger closure. As more functionality is added to advanced energy surgical devices, additional push-button switches or controls are added to the surgical device. These additional push-button switches or controls make these advanced energy surgical devices complex and difficult to use. Furthermore, when using advanced energy surgical devices to control bleeding, a difficult-to-use user interface or limited accessibility will consume critical time and attention during surgical procedures.

[0395] According to this disclosure, unipolar RF energy or advanced bipolar RF energy is activated by closing the trigger, which is squeezed through a first closing click to a second activation click and held closed until energy delivery is stopped by the power supply in the generator. Energy can also be immediately reapplied by slightly releasing and re-squeezing the trigger a number of times as needed.

[0396] Figure 96A surgical device 190 according to at least one aspect of the present disclosure is shown, comprising an activation mechanism including a trigger 196. 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, which, when compressed, is received into an internal space defined by the handle 194. The housing 192 is coupled to an end effector via a shaft 198 rotatable 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 ultrasound transducer.

[0397] Trigger 196 is configured to operate the gripping arm portion of the end effector and trigger electrosurgical energy, thus eliminating the need for... Figure 92 and Figure 94 The activation button switches 126 and 176 are shown. Trigger 196 closes to a first audible and tactile click to close the forceps for gripping 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 completed by activating the front button switch for cutting using ultrasonic energy.

[0398] 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.

[0399] 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.

[0400] 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.

[0401] For example, the above text combined Figures 92 to 96 The surgical instruments 100, 150, and 190 described, and the associated algorithms (including...) Figures 1 to 91 The end effector can be implemented, for example, in a surgical hub system in combination with a generator and a modular energy system.

[0402] Figure 97 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 97An 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.

[0403] In one respect, the combined ultrasound / bipolar RF energy surgical device is configured to operate within a surgical hub system. Figure 98 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 98 Hub 3106 is depicted as being integrated with visualization system 3108, robotic system 3110, and [other components]. Figures 92 to 97 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 98 As shown, hub 3106 also includes smoke extraction module 3126 and / or suction / flushing module 3128.

[0404] 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.

[0405] 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.

[0406] 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.

[0407] Some surgical procedures may require the application of more than one type of energy to tissue. One type of energy may be more advantageous for cutting tissue, while another different type of energy may be more advantageous for sealing tissue. For example, a bipolar generator can be used to seal tissue, while an ultrasonic generator can be used to cut sealed tissue. Aspects of this disclosure provide a solution in which a hub modular housing 136 is configured to accommodate different generators and facilitate interactive communication between them. One advantage of the hub modular housing 136 is that it allows for the rapid removal and / or replacement of various modules.

[0408] This disclosure provides 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 base including a first docking port including first data and power contacts, wherein the first energy generator module is slidably movable to electrically engage 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.

[0409] Further describing the above, the modular surgical housing also 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 base including a second docking port including second data and power contacts, wherein the second energy generator module is slidably movable to electrically engage 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.

[0410] In addition, the modular surgical housing also includes a communication bus between the first docking port and the second docking port, which is configured to facilitate communication between the first energy generator module and the second energy generator module.

[0411] In one aspect, this disclosure provides a generator configured to drive a combined ultrasound / bipolar RF energy surgical device. Figure 99 An example of a generator 3900 according to at least one aspect of this disclosure is shown. For example... Figure 99 As shown, generator 3900 is a type of generator configured to be connected to, for example, Figures 92 to 97 The surgical instruments 100, 150, and 190 are further configured to be capable of including, for example, Figure 98Adaptive ultrasound and electrosurgical control algorithms are executed in the surgical data network of the modular communication hub shown. Generator 3900 is configured to deliver multiple energy modes to surgical instruments. Generator 3900 provides RF signals and ultrasound signals for independently or simultaneously delivering energy to surgical instruments. The RF signals and ultrasound signals may be provided individually or in combination, and may be provided simultaneously. As described above, at least one generator output can deliver multiple energy modes (e.g., ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation and / or microwave energy, etc.) through a single port, and these signals may be delivered separately or simultaneously to an end effector to process tissue. Generator 3900 includes a processor 3902 coupled to a waveform generator 3904. Processor 3902 and waveform generator 3904 are configured to generate multiple signal waveforms based on information stored in a memory coupled to processor 3902, which is not shown for clarity in this disclosure. Digital information associated with the waveform is provided to a 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 amplifier 3906 is coupled to a power transformer 3908. The signal is coupled to a secondary side in the patient isolation area via the power transformer 3908. A first signal of a first energy mode is provided to a surgical instrument between terminals labeled ENERGY1 and RETURN. A second signal of a second energy mode is coupled across a capacitor 3910 and provided to a surgical instrument between terminals labeled ENERGY2 and RETURN. It should be understood that more than two energy modes can be output, and therefore the subscript “n” can be used to specify that up to n ENERGYn terminals are available, where n is a positive integer greater than 1. It should also be understood that up to “n” return paths RETURNn can be provided without departing from the scope of this disclosure.

[0412] A first voltage sensing circuit 3912 is coupled to both ends of a terminal labeled ENERGY1 and RETURN path to measure the output voltage between them. A second voltage sensing circuit 3924 is coupled to both ends of a terminal labeled ENERGY2 and RETURN path to measure the output voltage between them. As shown, a current sensing circuit 3914 is connected in series with the RETURN branch on the secondary side of the power transformer 3908 to measure the output current of any energy mode. If a different return path is provided for each energy mode, a separate current sensing circuit should be provided in each return branch. The outputs of the first voltage sensing circuit 3912 and the second voltage sensing circuit 3924 are provided to corresponding isolation transformers 3916, 3922, and the output of the current sensing circuit 3914 is provided to another isolation transformer 3918. The outputs of the isolation transformers 3916, 3928, 3922 on the primary side (non-patient isolation side) of the power transformer 3908 are provided to one or more ADC circuits 3926. The digitized output of the ADC circuit 3926 is provided to the processor 3902 for further processing and calculation. Output voltage and current feedback information can be used to adjust the output voltage and current supplied to surgical instruments, and parameters such as output impedance can be calculated. Input / output communication between the processor 3902 and the patient isolation circuit is provided through the interface circuit 3920. Sensors can also communicate electrically with the processor 3902 via the interface circuit 3920.

[0413] In one aspect, impedance can be determined by processor 3902 by dividing the output of a first voltage sensing circuit 3912 coupled to the terminals labeled ENERGY1 / RETURN or a second voltage sensing circuit 3924 coupled to the terminals labeled ENERGY2 / RETURN by the output of a current sensing circuit 3914 connected in series with the RETURN branch on the secondary side of power transformer 3908. The outputs of the first voltage sensing circuit 3912 and the second voltage sensing circuit 3924 are provided to separate isolation transformers 3916, 3922, and the output of the current sensing circuit 3914 is provided to another isolation transformer 3916. Digital voltage and current sensing measurements from ADC circuit 3926 are provided to processor 3902 for impedance calculation. For example, the first energy mode ENERGY1 can be ultrasonic energy, and the second energy mode ENERGY2 can be RF energy. However, in addition to ultrasonic and bipolar or unipolar RF energy modes, other energy modes include irreversible and / or reversible electroporation and / or microwave energy, etc. Moreover, although Figure 99The example shown illustrates that a single return path RETURN can be provided for two or more energy modes, but in other respects, multiple return paths RETURNn can be provided for each energy mode ENERGYn. Therefore, 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.

[0414] like Figure 99 As shown, a generator 3900, including at least one output port, may include a power transformer 3908 having a single output and multiple taps to provide power to the end effector in one or more energy modes (such as ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation and / or microwave energy, etc.) depending on the type of tissue treatment being performed. For example, the generator 3900 may deliver energy with higher voltage and lower current to drive an ultrasound transducer, with lower voltage and higher current to drive an RF electrode for sealing tissue, or with a coagulation waveform for point coagulation using monopolar or bipolar RF electrosurgical electrodes. The output waveform from the generator 3900 may be manipulated, switched, or filtered to provide a frequency to the end effector of the surgical instrument. The connection between the ultrasound transducer and the output of the generator 3900 will preferably be located between the outputs labeled ENERGY1 and RETURN, as shown below. Figure 98 As shown. In one example, the connection between the RF bipolar electrode and the output of generator 3900 would preferably be located between the outputs labeled ENERGY2 and RETURN. In the case of unipolar output, the preferred connection would be the active electrode (e.g., a pencil or other probe) at the ENERGY2 output and a suitable return pad connected to the RETURN output.

[0415] Additional details are disclosed in U.S. Patent Application Publication 2017 / 0086914, entitled “TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICALINSTRUMENTS”, published on March 30, 2017, the entire contents of which are incorporated herein by reference.

[0416] In one aspect, this disclosure provides a modular energy system configured to drive a combined ultrasound / bipolar RF energy surgical device. Figure 100 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. Figure 101A 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. Figure 101A It is installed on the cart according to at least one aspect of this disclosure. Figure 101B The modular energy system shown.

[0417] Now for reference Figures 99 to 101B Due to the sheer number of devices required to perform surgical procedures, surgical operations centers (ORs) everywhere in the world are a tangled web of cords, devices, and people. Surgical capital devices are often a major contributing factor to this problem, as most perform a single, specialized task. Because of their specialized nature, and the fact that surgeons need to use multiple different types of devices during a single surgical procedure, ORs may be forced to keep two or more surgical capital devices (such as power generators) on standby. Each of these surgical capital devices must be plugged into a power source and can be connected to one or more other devices passing between OR personnel, creating a tangled web 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 devices within the OR. This creates complexity in properly controlling multiple different devices connected to each other and forces users to be trained and memorize different types of user interfaces (which can be changed not only between capital devices but also based on the task or surgical procedure being performed). This cumbersome and complex process may require more personnel within the OR and can pose dangers if multiple devices are not properly cascaded and controlled. Therefore, integrating 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 operating room (OR) will simplify the user experience, reduce clutter in the OR, and prevent the difficulties and dangers associated with simultaneously controlling multiple capital devices. Furthermore, making such systems scalable or customizable will allow for the easy integration of new technologies into existing surgical systems without replacing the entire surgical system or requiring OR personnel to learn new user interfaces or device controls for each new technology.

[0418] Surgical hubs can be configured to interchangeably accommodate multiple modules that can then interact with surgical devices (e.g., surgical instruments or fumigators) or provide various other functions (e.g., communication). In one aspect, a surgical hub can be embodied as a combination of... Figures 100 to 101BThe modular energy system 4000 is shown. The modular energy system 4000 may include a variety of different modules 4001 capable of being connected together in a stacked configuration. In one aspect, the modules 4001 may be physically and communicatively coupled together when stacked or otherwise connected together to form a single component. Furthermore, the modules 4001 may be interchangeably connected together in different combinations or arrangements. In one aspect, each module in the module 4001 may include a consistent or generic array of connectors disposed along its upper and lower surfaces, thereby allowing any module 4001 to be connected to another module 4001 in any arrangement (the difference being that, in some aspects, a particular module type (such as head module 4002) may be configured to be used as, for example, the topmost module within a stack). In another aspect, the modular energy system 4000 may include a housing configured to receive and retain the modules 4001, such as... Figure 98 As shown. The modular energy system 4000 may also include various different components or accessories that can be connected to or otherwise associated with module 4001. On the other hand, the modular energy system 4000 may be embodied as generator modules 3140, 3900 of surgical hub 3106. Figures 98 to 99 In another respect, the modular power system 4000 may be a different system from the surgical hub 3106. In this respect, the modular power system 4000 may be communicatively coupled to the surgical hub 3106 for transmitting and / or receiving data therebetween.

[0419] The modular energy system 4000 can be assembled from a variety of different modules 4001, some examples of which are shown in... Figure 100As shown in the diagram. Each module in the different types of modules 4001 can provide different functions, thereby 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. Modules 4001 of the modular energy system 4000 may include, for example, a head module 4002 (which may include a display 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 used as the top or uppermost module within the modular energy system stack, and therefore may not include connectors along its top surface. In another aspect, the head module 4002 may be configured to be positioned at the bottom or lowermost module within the modular energy system stack, and therefore may not include connectors along its bottom surface. In yet another aspect, the head module 4002 may be configured to be positioned at an intermediate location within the modular energy system stack, and therefore may include connectors along both its bottom and top surfaces. Head module 4002 can be configured to control system-level settings for each module 4001 and connected components via physical controls 4011 on the head module and / or a graphical user interface (GUI) 4008 presented on display 4006. Such settings may include activation of the modular energy system 4000, alarm levels, foot switch settings, setting icons, the appearance or configuration of the user interface, surgeon profiles logged into the modular energy system 4000, and / or the type of surgical procedures being performed. Head module 4002 can also be configured to provide communication, processing, and / or power to modules 4001 connected to it. Energy module 4004 (which may also be referred to as generator modules 3140, 3900) Figures 98 to 99 It can be configured to generate one or more energy modes for driving electrosurgical instruments and / or ultrasound surgical instruments connected to the energy module, such as those described above. Figure 99 As shown in the generator 3900. The technology module 4040 can be configured to provide additional or extended control algorithms (e.g., an electrosurgical control algorithm or an ultrasound control algorithm for controlling the energy output of the energy module 4004). The visualization module 4042 can be configured to interact with a visualization device (i.e., an observation device), and thus enhance visualization capabilities.

[0420] The modular energy system 4000 may also include various accessories 4029 that can be connected to the module 4001 for controlling its functions, or otherwise configured to work in conjunction with the modular energy system 4000. Accessories 4029 may include, for example, a single-pedal foot switch 4032, a double-pedal foot switch 4034, and a trolley 4030 for supporting the modular energy system 4000 thereon. Foot switches 4032 and 4034 may be configured to control the activation or function of, for example, a specific energy mode output by the energy module 4004.

[0421] 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 facilities and / or surgeons. Furthermore, the modular energy system 4000 supports combined devices (e.g., dual-electrosurgical and ultrasound energy generators) and software-driven algorithms for customized tissue effects. Moreover, the surgical system architecture reduces capital footprint by combining multiple technologies crucial for surgical procedures into a single system.

[0422] The various modular components that can be used with the Modular Energy System 4000 may include monopolar energy generators, bipolar energy generators, dual electrosurgical / ultrasound energy generators, displays, and various other modules and / or components, some of which are also incorporated above. Figures 1 to 97 It has been described.

[0423] See now Figure 101AIn 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.

[0424] See still Figure 101A 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 100 to 101B 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.

[0425] 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, Figures 101A to 101BA first exemplary configuration of a 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.

[0426] Figures 49 to 53 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 49 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.

[0427] 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.

[0428] like Figure 50 and Figure 51 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 49 to 51Given 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.

[0429] 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.

[0430] like Figures 49 to 53 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 50 to 53 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.

[0431] In this example, the inner tube 48 is longitudinally fixed relative to the handle assembly 18, and the outer tube 46 is configured to translate relative to the inner tube 48 and the handle assembly 18 along the longitudinal axis of the shaft assembly 20. As the outer tube 46 translates distally, the clamping arm 38 pivots about the pivot pin 56 toward its open position. As the outer tube 46 translates proximally, the clamping arm 38 pivots in the opposite direction toward its closed position. The proximal end of the outer tube 46 is operatively coupled to a trigger 32, for example 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 opening or closing the clamping arm 38. In other suitable configurations not shown herein, the outer tube 46 may be longitudinally fixed, and the inner tube 48 may be configured to translate to move the clamping arm 38 between its open and closed positions.

[0432] The shaft assembly 20 and the end effector 22 are configured to rotate together with respect to the shank assembly 18 about a longitudinal axis. Figure 52 The retaining pin 66 shown extends laterally through the proximal portions of the outer tube 46, inner tube 48, and waveguide 50, thereby rotatably connecting these components relative to each other. In this 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 shank assembly 18. The knob 68 is rotatably secured to the shaft assembly 20 by a retaining pin 66 extending through a proximal collar of the knob 68. It should be understood that in other suitable configurations, the knob 68 may be omitted or replaced by an alternative rotary actuation structure.

[0433] The ultrasonic waveguide 50 is acoustically connected to the ultrasonic transducer 34 at its proximal end, for example, via a threaded connection, and to the ultrasonic scalpel 36 at its distal end, as... Figure 53As 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.

[0434] 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 52 to 53 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 53 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.

[0435] 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. oIt oscillates longitudinally in the range of approximately 20 to 50 micrometers. When the ultrasonic scalpel 36 is positioned to contact the tissue, the ultrasonic oscillations of the scalpel 36 can simultaneously cut the tissue and denature proteins in adjacent tissue cells, thereby providing a coagulation effect with minimal heat diffusion.

[0436] Example

[0437] Embodiments of various aspects of the end effectors and surgical instruments disclosed herein are provided below. One aspect of the end effector or surgical instrument may include any one or more of the following embodiments, and any combination thereof:

[0438] Example 1. An end effector comprising: a clamping arm; and an ultrasonic scalpel configured to be coupled to an ultrasonic transducer and to a pole of a generator; wherein the clamping arm comprises: a clamp; a cantilever electrode configured to be coupled 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 an I-beam clamping arm pad, wherein the clamping arm pad defines a top transverse portion and a bottom transverse portion separated by a middle portion to define an “I” shape, wherein the cantilever electrode is disposed between the top transverse portion and the bottom transverse portion of the I-beam clamping arm pad.

[0439] Example 2. The end effector according to Example 1 further includes a hard wear-resistant gap setting pad disposed at the proximal end of the cantilever electrode to set a gap between the cantilever electrode and the ultrasonic scalpel.

[0440] Example 3. An end effector according to any one of Examples 1 to 2, wherein the cantilever electrode defines a slot opening at the proximal end to slidably receive the middle portion of an I-beam shaped clamping arm pad.

[0441] Example 4. An end effector according to any one of Examples 1 to 3, wherein the clamp defines a longitudinal groove to slidably receive the bottom lateral portion and a portion of the middle portion of an I-beam shaped clamping arm pad passing through it.

[0442] Example 5. An end effector comprising: a clamping arm; and an ultrasonic scalpel configured to be coupled to an ultrasonic transducer and to a pole of a generator; wherein the clamping arm comprises: a clamp; a cantilever electrode configured to be coupled 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 a clamping arm pad; wherein the clamp, the cantilever electrode, and the clamping arm pad define a recess along a longitudinal length coinciding with the ultrasonic scalpel.

[0443] Example 6. The end effector according to Example 5, wherein the cantilever electrode is substantially flush with the ultrasonic scalpel in a fully clamped state but does not make metal contact with the ultrasonic scalpel, wherein the clamping arm pad includes a heavy polymer support pad.

[0444] Example 7. The end effector according to Example 6 further includes an orifice defined in the defined recess to heat-melt or fix the heavy polymer support pad to the cantilever electrode recess.

[0445] Example 8. An end effector comprising: a clamping arm; and an ultrasonic scalpel configured to be coupled to an ultrasonic transducer and to a pole of a generator; wherein the clamping arm comprises: a clamp having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point; a cantilever electrode configured to be coupled to the opposite pole of the generator, wherein the cantilever electrode includes a proximal end fixed to the proximal end of the clamp and a freely deflectable distal end, and the cantilever electrode defines a surface configured to contact tissue and apply electrical energy to the tissue in contact therewith; and a clamping arm pad fixed to the clamp and having at least a portion disposed between the clamp and the cantilever electrode and another portion extending beyond the surface of the cantilever electrode to contact tissue.

[0446] Example 9. The end effector according to Example 8 further includes at least one gap pad, which is fixed to the cantilever electrode to set a gap between the ultrasonic scalpel and the cantilever electrode.

[0447] Example 10. The end effector according to Example 9, wherein the gap pad is located at the proximal end of the cantilever electrode.

[0448] Example 11. The end effector according to any one of Examples 9 to 10, wherein the gap pad is made of a material with a hardness greater than that of the clamping arm pad, such that the gap pad has a longer wear life than the clamping arm pad, wherein the gap pad material is non-flexible and the clamping arm pad material is flexible, and wherein the clamping arm pad is made of a flexible material.

[0449] Example 12. An end effector according to any one of Examples 9 to 11, wherein the cantilever electrode defines a gap pad located at the proximal end of the cantilever electrode, a gap pad located at the distal end of the cantilever electrode, and a gap pad located between the proximal end and the distal end.

[0450] Example 13. An end effector according to any one of Examples 8 to 12, wherein the clamping arm pad includes a base portion fixedly attached to the clamp and a plurality of teeth extending from the base in a direction toward the cantilever electrode.

[0451] Example 14. The end effector according to any one of Examples 8 to 13 further includes: at least one gap pad, the at least one gap pad fixing the cantilever electrode to establish a gap between the ultrasonic scalpel and the cantilever electrode; wherein the clamping arm pad includes a base portion fixedly attached to the clamp and a plurality of teeth extending from the base portion in a direction toward the cantilever electrode; and wherein the cantilever electrode defines a plurality of orifices, the orifices being sized and configured to receive at least one gap pad and the plurality of teeth passing through therethrough; wherein the cantilever electrode defines at least one orifice on the proximal side, thereby defining an open end to slidably receive one of the gap pads; and a gap pad located at the distal end of the cantilever electrode and a gap pad located between the distal end and the proximal end of the cantilever electrode, wherein the size of the proximal gap pad is larger than that of the distal gap pad and the inner gap pad.

[0452] Example 15. An end effector comprising: a clamping arm; and an ultrasonic scalpel configured to be coupled to an ultrasonic transducer and to a pole of a generator; wherein the clamping arm comprises: a clamp; a cantilever electrode configured to be coupled 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; a stationary gap setting pad located at the distal end of the clamping arm; and a movable floating gap setting pad, thereby forming a composite arrangement to generate ultrasonic scalpel pressure while also setting a minimum gap between the cantilever electrode and the ultrasonic scalpel.

[0453] Example 16. The end effector according to Example 15, wherein the clamping arm further includes a clamping arm pad attached to the clamp.

[0454] Example 17. An end effector according to any one of Examples 15 to 16, wherein a stationary clearance setting pad is attached to the clamp.

[0455] Example 18. An end effector according to any one of Examples 15 to 17, wherein the stationary gap setting pad is configured to apply end pressure and assist tissue gripping and prevent short circuit between the cantilever electrode and the ultrasonic scalpel.

[0456] Example 19. The end effector according to any one of Examples 15 to 18 further includes a stationary clamping arm pad, wherein a movable floating gap setting pad forms a composite arrangement to apply pressure to the ultrasonic scalpel and to set a minimum gap between the cantilever electrode and the ultrasonic scalpel.

[0457] Although several forms have been illustrated and described, the applicant does not intend to limit or restrict the scope of the appended claims to such details. Many modifications, variations, alterations, substitutions, combinations, and equivalents of these forms can be made without departing from the scope of this disclosure, and those skilled in the art will recognize such modifications, variations, alterations, substitutions, combinations, and equivalents. Furthermore, alternatively, the structure of each element associated with a described form can be described as a device for providing the function performed by said element. Additionally, where materials for certain components are disclosed, other materials may also be used. Therefore, it should be understood that the foregoing detailed descriptions and the appended claims are intended to cover all such modifications, combinations, and variations falling within the scope of the forms disclosed in this invention. The appended claims are intended to cover all such modifications, variations, alterations, substitutions, modifications, and equivalents.

[0458] The specific embodiments described above have illustrated various forms of apparatus and / or methods using block diagrams, flowcharts, and / or examples. Wherever such block diagrams, flowcharts, and / or examples contain one or more functions and / or operations, those skilled in the art will understand that each function and / or operation in such block diagrams, flowcharts, and / or examples can be implemented individually and / or collectively by various hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will recognize that some aspects of the forms disclosed herein can be equivalently implemented in an integrated circuit, wholly or partially, as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or as any combination thereof, and that designing circuit systems and / or writing software and / or hardware code according to this disclosure will be within the skill of those skilled in the art. Furthermore, those skilled in the art will recognize that the mechanisms of the subject matter described herein can be distributed as one or more program products in various forms, and that the exemplary forms of the subject matter described herein apply regardless of the specific type of signal-bearing medium used for actual distribution.

[0459] Instructions used for programming logic to execute various disclosed aspects may be stored in the system's memory, such as dynamic random access memory (DRAM), cache, flash memory, or other memory. Furthermore, the instructions may be distributed via a network or through other computer-readable media. Therefore, machine-readable media may include any means for storing or transmitting information in a machine-readable (e.g., computer-readable) form, but are not limited to floppy disks, optical disks, optical disc read-only memory (CD-ROM), and magneto-optical disks, read-only memory (ROM), random access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), magnetic cards or optical cards, flash memory, or tangible machine-readable storage devices used for transmitting information over the Internet via electrical signals, optical signals, acoustic signals, or other forms of propagation signals (e.g., carrier waves, infrared signals, digital signals, etc.). Therefore, non-transitory computer-readable media include any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a machine-readable (e.g., computer-readable) form.

[0460] As used in any aspect of this document, the term "control circuit" may refer to, for example, hardwired circuit systems, programmable circuit systems (e.g., computer processors 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 circuit systems, firmware storing instructions executed by the programmable circuit system, and any combination thereof. Control circuits may be implemented collectively or individually as part of a larger system, such as integrated circuits (ICs), application-specific integrated circuits (ASICs), system-on-a-chip (SoCs), desktop computers, laptop computers, tablet computers, servers, smartphones, etc. Therefore, as used herein, "control circuit" includes, but is not limited to, electronic circuits having at least one discrete circuit, electronic circuits having at least one integrated circuit, electronic circuits having at least one application-specific integrated circuit, and electronic circuits forming a general-purpose computing device configured by a computer program (e.g., a computer program at least partially implementing the methods and / or devices described herein).

[0461] The subject matter described herein can be implemented in a general-purpose computer configured by a computer program, or at least in part by a microprocessor configured by a computer program to implement the methods and / or devices described herein, electronic circuitry forming memory devices (e.g., random access memory), and / or electronic circuitry forming communication devices (e.g., modems, communication switches, or optoelectronic devices). Those skilled in the art will recognize that the subject matter described herein can be implemented in analog or digital modes, or some combination thereof.

[0462] As used in any aspect of this document, the term "logic" can refer to an application, software, firmware, and / or circuit system configured to perform any of the foregoing operations. Software can be embodied in software packages, code, instructions, instruction sets, and / or data recorded on a non-transitory computer-readable storage medium. Firmware can be embodied in hard-coded (e.g., non-volatile) code, instructions, or instruction sets and / or data in a memory device.

[0463] As used in any part of this document, the terms “component,” “system,” “module,” etc., can refer to computer-related entities, hardware, combinations of hardware and software, software, or software in execution.

[0464] As used in any aspect of this document, "algorithm" refers to a systematic sequence of steps that leads to a desired result, where "step" refers to the manipulation of physical quantities and / or logical states, which may (but not necessarily) take the form of electrical or magnetic signals that can be stored, transferred, combined, compared, and otherwise manipulated. These signals are commonly referred to as bits, values, elements, symbols, characters, terms, numbers, etc. These and similar terms may be associated with appropriate physical quantities and are merely convenient labels applied to these quantities and / or states.

[0465] The network may include a packet-switched network. Communication devices may be able to communicate with each other using a selected packet-switched network communication protocol. An exemplary communication protocol may include an Ethernet communication protocol that may allow communication using Transmission Control Protocol / Internet Protocol (TCP / IP). The Ethernet protocol may conform to or be compatible with the Ethernet standard entitled "IEEE 802.3 Standard" published by the Institute of Electrical and Electronics Engineers (IEEE) in December 2008 and / or a higher version of this standard. Alternatively or additionally, communication devices may be able to communicate with each other using the X.25 communication protocol. The X.25 communication protocol may conform to or be compatible with standards published by the International Telecommunication Union Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, communication devices may be able to communicate with each other using the Frame Relay communication protocol. The Frame Relay communication protocol may conform to or be compatible with standards published by the International Telegraph and Telephone Consultative Committee (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, transceivers may be able to communicate with each other using the Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard entitled "ATM-MPLS Network Interworking 2.0" and / or a higher version of that standard, published by the ATM Forum in August 2001. Of course, this document also envisions different and / or subsequently developed connectivity-oriented network communication protocols.

[0466] Unless otherwise expressly stated in the foregoing disclosure, it is understood that in the foregoing disclosure, discussions using terms such as “processing,” “estimating,” “calculating,” “determining,” and “displaying” refer to the actions and processes of a computer system or similar electronic computing device that manipulate data represented as physical (electronic) quantities in the registers and memories of the computer system and convert them into other data similarly represented as physical quantities in the memory or registers of the computer system or other such information storage, transmission, or display devices.

[0467] One or more components may be referred to herein as “configured to be,” “configurable to be,” “operable / operationally,” “suitable / adaptable,” “capable,” “adaptable / fittable,” etc. Those skilled in the art will recognize that, unless the context otherwise requires, “configured to be” generally encompasses components in an active state and / or in an inactive state and / or in a standby state.

[0468] The terms "proximal" and "distal" are used herein in relation to the clinician manipulating the handle portion of the surgical instrument. "Proximal" refers to the portion closest to the clinician, and "distal" refers to the portion furthest from the clinician's position. It should also be understood that, for brevity and clarity, spatial terms such as "vertical," "horizontal," "upper," and "lower" may be used in conjunction with accompanying drawings. However, surgical instruments are used in many orientations and locations, and these terms are not restrictive and / or absolute.

[0469] Those skilled in the art will recognize that, in general, the terminology used herein, and particularly in the appended claims (e.g., the text of the appended claims), is typically intended to be “open” terms (e.g., the term “comprising” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “at least having,” the term “including” should be interpreted as “comprising but not limited to,” etc.). Those skilled in the art will also understand that if a specific number of statements in the introduced claims is intended, such an intention will be explicitly stated in the claims, and if no such statement is present, such an intention does not exist. For example, to aid understanding, the appended claims below may contain the use of the introductory phrases “at least one” and “one or more” to introduce the claims. However, the use of such phrases should not be construed as implying that introducing a claim statement with the indefinite article "a" or "an" limits any particular claim containing such an introductory claim statement to a claim containing only one such statement, even when the same claim includes the introductory phrase "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 as meaning "at least one" or "one or more"); this also applies to the use of definite articles used to introduce a claim statement.

[0470] 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".

[0471] 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.

[0472] 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.

[0473] Any patent application, patent, non-patent publication, or other public material mentioned in this specification and / or listed in any application data sheet is incorporated herein by reference, provided that the incorporated material is inconsistent with this specification. Therefore, and to the extent necessary, the disclosures expressly listed herein replace any conflicting material incorporated herein by reference. Any material or portion thereof allegedly incorporated herein by reference that conflicts with existing definitions, statements, or other public materials listed herein will be incorporated only to the extent that the incorporated material does not conflict with existing public materials.

[0474] In summary, many beneficial effects resulting from employing the concepts described herein have been described. For illustrative and descriptive purposes, one or more of the specific embodiments described above have been provided. These embodiments are not intended to be exhaustive or limited to the precise forms disclosed in the invention. Modifications or variations may be made to the invention in accordance with the teachings above. The one or more forms chosen and described are intended to illustrate the principles and practical applications, thereby enabling those skilled in the art to utilize various forms and modifications suitable for the intended particular use. The claims filed herein are intended to define the full scope.

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 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 deflects at a distal end; and I-shaped beam clamping arm pad, wherein the clamping arm pad defines a top transverse portion and a bottom transverse portion separated by a middle portion to define an "I" shape, wherein the cantilever electrode is disposed between the top transverse portion and the bottom transverse portion of the I-shaped beam clamping arm pad.

2. The end effector according to claim 1, further comprising a hard wear-resistant gap setting pad disposed at the proximal end of the cantilever electrode to set a gap between the cantilever electrode and the ultrasonic scalpel.

3. The end effector according to claim 1, wherein, The cantilever electrode defines a slot opening at its proximal end to slidably receive the middle portion of the I-beam clamping arm pad.

4. The end effector according to claim 1, wherein, The clamp defines a longitudinal groove to slidably receive the bottom lateral portion and a portion of the middle portion of the I-beam clamping arm pad passing through the longitudinal groove.

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