A deflectable electrode having a variable compression bias along the length of the deflectable electrode

Abstract

An end effector is disclosed. The end effector includes a clamp arm and an ultrasonic blade configured to acoustically couple to an ultrasonic transducer and electrically couple to one pole of a generator. The clamp arm includes a jaw, a plurality of variable longitudinal support elements, and a cantilevered electrode configured to electrically couple to an opposite pole of the generator, the cantilevered electrode being fixed to the jaw at a proximal end and free to deflect at a distal end. The cantilevered electrode is supported by the variable longitudinal support elements. The variable longitudinal support elements exert a variable force on the cantilevered electrode from the proximal end to the distal end.

Description

[0001] Cross Reference to Related Applications

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

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

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

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

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

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

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

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

[0010] A challenge with these surgical instruments is the inability to control and customize the single or multiple energy modalities according to the type of tissue being treated. It would be desirable to provide an end effector that overcomes some of the deficiencies of current surgical instruments and improves the quality of tissue treatment, sealing, or cutting or a combination of these operations. The combined energy modality end effectors described herein overcome these deficiencies and improve the quality of tissue treatment, sealing, or cutting or a combination of these operations. SUMMARY

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

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

[0013] In one aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a movable jaw, a flexible polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, the at least one electrode acts as a deflectable support relative to the opposing ultrasonic blade. The at least one electrode passes through the ultrasonic blade and is configured to be deflectable relative to the clamp arm having a feature that changes the mechanical properties of tissue compression beneath the at least one electrode. The at least one electrode includes a feature that prevents accidental contact between the electrode and the ultrasonic blade.

[0014] In another aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a movable jaw, a flexible polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, the movable jaw includes at least one non-biased deflectable electrode to minimize contact between the ultrasonic blade and the RF electrode. The ultrasonic blade pad includes a feature for securing the electrode to the pad. As the pad wears down or is cut through, the height of the electrode relative to the jaw is adjusted in a gradual manner. Once the jaw is moved away from the ultrasonic blade, the electrode remains in its new position.

[0015] In another aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a movable jaw, a flexible polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, the at least one bipolar RF electrode is deflectable and has more distal bias than proximal bias. The bipolar RF electrode is deflectable relative to the jaw. The end effector is configured to change the mechanical properties of tissue compression from the proximal end to the distal end to create a more uniform or different pressure pattern than that created by clamping alone.

[0016] In another aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a movable clamp jaw, a flexible polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, the bipolar RF electrode is deflectable and the end effector provides variable compression / biasing along the length of the deflectable electrode. The end effector is configured to vary the mechanical properties of tissue compression under the electrode based on the amount of jaw closure or clamping.

[0017] In another aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a movable clamp jaw, a flexible polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, the pad includes asymmetric segments to provide support to the ultrasonic blade support and the electrode is movable. The asymmetric segmented pad is configured for cooperative engagement with the movable bipolar RF electrode. The segmented ultrasonic support pad extends at least partially through the bipolar RF electrode. At least one pad element is substantially higher than a second pad element. The first pad element extends entirely through the bipolar RF electrode and the second pad element extends partially through the bipolar RF electrode. The first pad element and the second pad element are made of different materials.

[0018] In another aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a movable clamp jaw, a flexible polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, the physical parameters of the electrode are varied in conjunction with a deflectable electrode to vary the energy density and tissue interaction delivered to the tissue. The physical aspects of the electrode vary along its length so as to vary the contact area and / or energy density of the electrode to the tissue as the electrode is also deflected.

[0019] In another aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a movable clamp jaw, a flexible polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to the positive pole of an RF generator and the ultrasonic blade is coupled to the negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, an ultrasonic transducer control algorithm is provided to reduce the power delivered by the ultrasonic or RF generator upon detection of a contact short between the ultrasonic blade and the electrode, thereby preventing damage to the ultrasonic blade. The ultrasonic blade control algorithm monitors for an electrical short or contact of the ultrasonic blade with the electrode. This detection is used to adjust the power / amplitude level of the ultrasonic transducer when an electrical threshold minimum is exceeded, and the transducer power / amplitude threshold is adjusted to a level below the minimum threshold that can cause damage to the ultrasonic blade, the ultrasonic generator, the bipolar RF electrode, or the bipolar RF generator. The electrical parameter monitored can be tissue impedance (Z) or electrical continuity. The power adjustment can be to shut off the ultrasonic generator, the bipolar RF generator of the surgical device, or it can be a proportional response to the electrical parameter, pressure, or time, or any combination of these parameters.

[0020] In another aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a movable clamp jaw, a flexible polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to the positive pole of an RF generator and the ultrasonic blade is coupled to the negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, features or aspects of the clamp jaw are provided in the clamp arm to minimize tissue sticking and improve tissue control. The clamp arm tissue path or clamp area includes features configured to enable adjustment of the tissue path relative to the clamp arm / ultrasonic blade to create predetermined contact locations to reduce tissue sticking and charring.

[0021] In another aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a movable jaw, a flexible polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator, and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, a partially conductive clamp arm pad is provided to enable the electrode to wear through and minimize electrical shorting between the ultrasonic blade and the bipolar RF electrode. The clamp arm pad includes a conductive portion and a non-conductive portion, such that it acts as one of the bipolar RF electrodes while also acting as a wear-resistant support structure for the ultrasonic blade. The conductive portion of the clamp arm pad is positioned around the perimeter of the pad and not directly under the ultrasonic blade contact area. The conductive portion is configured to be able to deteriorate or wear away to prevent any contact with the ultrasonic blade from interrupting the conductivity of the remaining conductive pad.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[0058] Figure 30 is a cross-sectional view of an alternative implementation of a clamp arm including a clamp jaw, a conductive pad, and a non-conductive pad according to at least one aspect of the present disclosure.

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

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

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

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

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

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

[0065] Figure 37 A clamp arm is shown including a clamp, a support having a hinged feature, an electrode, and a clamp arm pad according to at least one aspect of the present disclosure.

[0066] Figure 38 A clamp arm is shown according to at least one aspect of the present disclosure Figure 37 A cross-sectional view through the clamp arm pad is shown for the clamp arm in an unloaded condition.

[0067] Figure 39 A clamp arm is shown according to at least one aspect of the present disclosure Figure 37 A cross-sectional view of the clamp arm is shown in a loaded condition to collapse the support having a hinged feature under a force Fl applied to the electrode.

[0068] Figure 40 A clamp arm portion of an end effector is shown according to at least one aspect of the present disclosure, where the clamp arm includes a clamp, a clamp arm pad, a variable longitudinal support element, a tab extension, and an electrode supported by the variable longitudinal support element.

[0069] Figure 41A to Figure 41C A clamp arm is shown according to at least one aspect of the present disclosure in various loaded conditions Figure 40 A clamp arm is shown, where:

[0070] Figure 41A A clamp arm is shown in a new firing condition with no load or a uniformly distributed load;

[0071] Figure 41B A clamp arm is shown in a high load condition, where there is a high force at the distal end and a low force at the proximal end; and

[0072] Figure 41C A clamp arm is shown in a high load with a tab extension that is worn, where there is a high load at the distal end, a low load at the proximal end, and a median load at the center.

[0073] Figure 42 A general configuration of an end effector is shown according to at least one aspect of the present disclosure, including a clamp arm, an ultrasonic blade, an electrode, a flexible material that acts as a spring between the electrode and the clamp arm fixed to the clamp arm, and a hard wear-resistant material fixed to a proximal end of the electrode to set a gap between the electrode and the clamp arm.

[0074] Figure 43 A top view of an electrode is shown, showing an aperture for receiving a flexible material therethrough.

[0075] Figure 44 to Figure 45 A clamp arm is shown according to at least one aspect of the present disclosure Figure 42 to Figure 43A first configuration of the end effector is shown, including a leaf spring element at a distal end of the electrode.

[0076] Figure 45 is a magnified view of the distal end of the electrode, showing the leaf spring element.

[0077] Figure 46 to Figure 48 is shown according to at least one aspect of the present disclosure Figure 42 to Figure 43 A second configuration of the end effector is shown, including a leaf spring element at a distal end of the electrode; wherein

[0078] Figure 47 is a cross-sectional view of the tube, showing the ultrasonic blade and wire; and

[0079] Figure 48 is a cross-sectional view of the clamp arm, showing the electrode and leaf spring element.

[0080] Figure 49 is shown according to at least one aspect of the present disclosure Figure 42 to Figure 43 A third configuration of the end effector is shown, including a compressible material attached to a bottom portion of a distal end of the electrode.

[0081] Figure 50 is shown according to at least one aspect of the present disclosure

[0082] Figure 51A to Figure 51C is shown according to at least one aspect of the present disclosure for selecting various modes of operation of a surgical device, wherein:

[0083] Figure 51A is shown a first mode selection option, wherein the button switch can be pressed forward or backward to cycle the surgical instrument between various modes;

[0084] Figure 51B is shown a second mode selection option, wherein the button switch is pressed up or down to cycle the surgical instrument between various modes; and

[0085] Figure 51C is shown a third mode selection option, wherein the button switch is pressed forward, backward, up, or down to cycle the surgical instrument between various modes.

[0086] Figure 52 is shown according to at least one aspect of the present disclosure

[0087] Figure 53AA first mode selection option is shown, where a colored light indicates the selected mode on the user interface as the mode button switch is pressed to switch between various modes.

[0088] Figure 53B A second mode selection option is shown, where a screen indicates the selected mode (e.g., LCD, e-ink) as the mode button switch is pressed to switch between various modes.

[0089] Figure 53C A third mode selection option is shown, where a labeled light indicates the selected mode as the mode button switch is pressed to switch between various modes.

[0090] Figure 53D A fourth mode selection option is shown, where a labeled button switch is pressed to select a mode, and when the labeled button switch is selected, it is illuminated to indicate the selected mode.

[0091] Figure 54 A surgical device including a trigger activation mechanism is shown in accordance with at least one aspect of the present disclosure.

[0092] Figure 55 An alternative clamp arm including a metal clamp, an electrode, a plurality of clamp arm pads, and a gap pad is shown in accordance with at least one aspect of the present disclosure.

[0093] Figure 56 A surgical system including a surgical hub paired with a visualization system, a robotic system, and a smart instrument in accordance with at least one aspect of the present disclosure.

[0094] Figure 57 An example of a generator is shown in accordance with at least one aspect of the present disclosure.

[0095] Figure 58 A diagram of a variety of modules and other components that can be combined to customize a modular energy system in accordance with at least one aspect of the present disclosure.

[0096] Figure 59A A first example modular energy system configuration including a head module and a display screen that presents a graphical user interface (GUI) for relaying information about modules connected to the head module in accordance with at least one aspect of the present disclosure.

[0097] Figure 59B A modular energy system mounted to a cart in accordance with at least one aspect of the present disclosure. Figure 59A

[0098] Figure 60 ​A perspective view of an exemplary surgical system is shown in accordance with at least one aspect of the present disclosure, the system having a generator and a surgical instrument operable to treat tissue with ultrasonic energy and bipolar RF energy.

[0099] Figure 61 A perspective view of an exemplary surgical system is shown in accordance with at least one aspect of the present disclosure, the system having a generator and a surgical instrument operable to treat tissue with ultrasonic energy and bipolar RF energy. Figure 60 A top perspective view of an end effector of a surgical instrument is shown in accordance with at least one aspect of the present disclosure, the end effector having a clamp arm providing a first electrode and an ultrasonic blade providing a second electrode.

[0100] Figure 62 A perspective view of an exemplary surgical system is shown in accordance with at least one aspect of the present disclosure, the system having a generator and a surgical instrument operable to treat tissue with ultrasonic energy and bipolar RF energy. Figure 61 A bottom perspective view of an end effector is shown in accordance with at least one aspect of the present disclosure.

[0101] Figure 63 A perspective view of an exemplary surgical system is shown in accordance with at least one aspect of the present disclosure, the system having a generator and a surgical instrument operable to treat tissue with ultrasonic energy and bipolar RF energy. Figure 60 A partial exploded perspective view of a surgical instrument is shown in accordance with at least one aspect of the present disclosure.

[0102] Figure 64 A perspective view of an exemplary surgical system is shown in accordance with at least one aspect of the present disclosure, the system having a generator and a surgical instrument operable to treat tissue with ultrasonic energy and bipolar RF energy. Figure 60 An enlarged exploded perspective view of a distal portion of a shaft assembly of a surgical instrument and an end effector is shown in accordance with at least one aspect of the present disclosure. DETAILED DESCRIPTION

[0103] Applicant of the present application owns the following U.S. Provisional Patent Applications that were filed on December 30, 2019 and are each herein incorporated by reference in their entirety:

[0104] • U.S. Provisional Patent Application Serial No. 62 / 955,294, entitled USER INTERFACE FOR SURGICAL INSTRUMENT WITH COMBINATION ENERGY MODALITY END- EFFECTOR;

[0105] • U.S. Provisional Patent Application Serial No. 62 / 955,299, entitled ELECTROSURGICAL INSTRUMENTS FOR COMBINATION ENERGY DELIVERY; and

[0106] • U.S. Provisional Patent Application Serial No. 62 / 955,306, entitled SURGICAL INSTRUMENTS.

[0107] Applicant of the present application owns the following U.S. Patent Applications that were filed on the same date as the present application and which are each herein incorporated by reference in their entirety:

[0108] • Attorney Docket No. END9232USNP1 / 190715-1, entitled USER INTERFACE FOR SURGICAL INSTRUMENT WITH COMBINATION ENERGY MODALITY END-EFFECTOR;

[0109] • Attorney Docket No. END9233USNP1 / 190716-1M, entitled METHOD OF OPERATING A COMBINATION ULTRASONIC / BIPOLAR RF SURGICAL DEVICE WITH A COMBINATION ENERGY MODALITY END-EFFECTOR;

[0110] • Attorney Docket No. END9233USNP2 / 190716-2, entitled DEFLECTABLE SUPPORT OF RF ENERGY ELECTRODE WITH RESPECT TO OPPOSING ULTRASONIC BLADE;

[0111] • Attorney Docket No. END9233USNP3 / 190716-3, entitled NON-BIASED DEFLECTABLE ELECTRODE TO MINIMIZE CONTACT BETWEEN ULTRASONIC BLADE AND ELECTRODE;

[0112] • Attorney Docket No. END9233USNP4 / 190716-4, entitled DEFLECTABLE ELECTRODE WITH HIGHER DISTAL BIAS RELATIVE TO PROXIMAL BIAS;

[0113] • Attorney Docket No. END9233USNP6 / 190716-6, entitled ASYMMETRIC SEGMENTED ULTRASONIC SUPPORT PAD FOR COOPERATIVE ENGAGEMENT WITH A MOVABLE RF ELECTRODE;

[0114] • Attorney Docket No. END9233USNP7 / 190716-7, entitled VARIATION IN ELECTRODE PARAMETERS AND DEFLECTABLE ELECTRODE TO MODIFY ENERGY DENSITY AND TISSUE INTERACTION;

[0115] • Attorney Docket No. END9233USNP8 / 190716-8, entitled TECHNIQUES FOR DETECTING ULTRASONIC BLADE TO ELECTRODE CONTACT AND REDUCING POWER TO ULTRASONIC BLADE;

[0116] • Attorney Docket No. END9233USNP9 / 190716-9, entitled CLAMP ARM JAW TO MINIMIZE TISSUE STICKING AND IMPROVE TISSUE CONTROL; and

[0117] • Attorney Docket No. END9233USNP10 / 190716-10, entitled PARTIALLY CONDUCTIVE CLAMP ARM PAD TO ENABLE ELECTRODE WEAR THROUGH AND MINIMIZE SHORT CIRCUITING.

[0118] Applicant of the present application owns the following U.S. Patent Applications that were filed on May 28, 2020 and which are each herein incorporated by reference in their respective entirety:

[0119] • U.S. Patent Application Serial No. 16 / 885,813, entitled METHOD FOR AN ELECTROSURGICAL PROCEDURE;

[0120] • U.S. Patent Application Serial No. 16 / 885,820, entitled ARTICULATABLE SURGICAL INSTRUMENT;

[0121] • U.S. Patent Application Serial No. 16 / 885,823, entitled SURGICAL INSTRUMENT WITH JAW ALIGNMENT FEATURES;

[0122] • U.S. Patent Application Serial No. 16 / 885,826, entitled SURGICAL INSTRUMENT WITH ROTATABLE AND ARTICULATABLE SURGICAL END EFFECTOR;

[0123] • U.S. Patent Application Serial No. 16 / 885,838, entitled ELECTROSURGICAL INSTRUMENT WITH ASYNCHRONOUS ENERGIZING ELECTRODES;

[0124] • U.S. Patent Application Serial No. 16 / 885,851, entitled ELECTROSURGICAL INSTRUMENT WITH ELECTRODES BIASING SUPPORT;

[0125] • U.S. Patent Application Serial No. 16 / 885,860, entitled ELECTROSURGICAL INSTRUMENT WITH FLEXIBLE WIRING ASSEMBLIES;

[0126] • U.S. Patent Application Serial No. 16 / 885,866, entitled ELECTROSURGICAL INSTRUMENT WITH VARIABLE CONTROL MECHANISMS;

[0127] • U.S. Patent Application Serial No. 16 / 885,870, entitled ELECTROSURGICAL SYSTEMS WITH INTEGRATED AND EXTERNAL POWER SOURCES;

[0128] • U.S. Patent Application Serial No. 16 / 885,873, entitled ELECTROSURGICAL INSTRUMENTS WITH ELECTRODES HAVING ENERGY FOCUSING FEATURES;

[0129] • U.S. Patent Application Serial No. 16 / 885,879, entitled ELECTROSURGICAL INSTRUMENTS WITH ELECTRODES HAVING VARIABLE ENERGY DENSITIES;

[0130] • U.S. Patent Application Serial No. 16 / 885,881, entitled ELECTROSURGICAL INSTRUMENT WITH MONOPOLAR AND BIPOLAR ENERGY CAPABILITIES;

[0131] • U.S. Patent Application Serial No. 16 / 885,888, entitled ELECTROSURGICAL END EFFECTORS WITH THERMALLY INSULATIVE AND THERMALLY CONDUCTIVE PORTIONS;

[0132] • U.S. Patent Application Serial No. 16 / 885,893, entitled ELECTROSURGICAL INSTRUMENT WITH ELECTRODES OPERABLE IN BIPOLAR AND MONOPOLAR MODES;

[0133] • U.S. Patent Application Serial No. 16 / 885,900, entitled ELECTROSURGICAL INSTRUMENT FOR DELIVERING BLENDED ENERGY MODALITIES TO TISSUE;

[0134] • U.S. Patent Application Serial No. 16 / 885,917, entitled CONTROL PROGRAM ADAPTATION BASED ON DEVICE STATUS AND USER INPUT;

[0135] • U.S. Patent Application Serial No. 16 / 885,923, entitled CONTROL PROGRAM FOR MODULAR COMBINATION ENERGY DEVICE; and

[0136] • U.S. Patent Application Serial No. 16 / 885,931, entitled SURGICAL SYSTEM COMMUNICATION PATHWAYS.

[0137] Before the various forms of the surgical instrument are described in detail, it is to be understood that the application of the example forms is not limited in scope to the details of construction and the arrangement of the components shown in the figures and described in the specific embodiments. The example forms can be implemented or incorporated in other forms, variations and modifications, and can be practiced or carried out in various ways. Furthermore, the terms and expressions employed herein have been chosen for the purpose of describing the example forms for the convenience of the reader and are not for the purpose of limitation unless otherwise indicated.

[0138] Furthermore, it should be appreciated that any one or more of the following forms, form expressions, examples can be combined with any one or more of the following other forms, form expressions, and examples.

[0139] Various forms relate to improved ultrasonic and / or electrosurgical (RF) instruments configured for performing tissue treatment, dissection, cutting, and / or coagulation during surgical procedures. In one form, a combined ultrasonic and electrosurgical instrument can be configured for open surgical procedures, but also applies to other types of surgical procedures, such as minimally invasive laparoscopic, visual or thoracoscopic procedures, e.g., non-invasive endoscopic procedures in hand-held or robot-assisted procedures. The versatility is achieved by selectively applying multiple energy modalities simultaneously, independently, sequentially, or a combination thereof. For example, the versatility can be achieved by selectively using ultrasonic and electrosurgical energy (e.g., monopolar or bipolar RF energy) simultaneously, independently, sequentially, or a combination thereof.

[0140] In one aspect, the present disclosure provides an ultrasonic surgical clamping device comprising an ultrasonic blade and a deflectable RF electrode such that the ultrasonic blade and deflectable RF electrode cooperate to perform sealing, cutting, and clamping of tissue by the cooperation of the clamping mechanism of the device comprising the RF electrode and the associated ultrasonic blade. The clamping mechanism comprises a pivoting clamp arm that cooperates with the ultrasonic blade to grasp tissue therebetween. The clamp arm preferably has a clamping tissue pad (also referred to as a "clamp arm pad") having a plurality of axially spaced-apart clamping teeth, segments, elements, or individual units that cooperate with the ultrasonic blade of the end effector to achieve the desired sealing and cutting effects on tissue while facilitating grasping and clamping of tissue during a surgical procedure.

[0141] In one aspect, the end effectors described herein include an electrode. In other aspects, the end effectors described herein include alternative forms of electrodes to provide flexible coupling of RF energy to tissue, accommodate pad wear / thinning, minimize generation of excess heat (low coefficient of friction, pressure), minimize generation of sparks, minimize interruptions due to electrical shorts, or other combinations thereof. The electrode is fixed to the clamp jaw at a proximal end and is free to deflect at a distal end. Thus, throughout this disclosure, the electrode can be referred to as a cantilevered beam electrode or deflectable electrode.

[0142] In other aspects, the end effectors described herein include a clamp arm mechanism configured to be able to apply high pressure between the pad and the ultrasonic blade to grasp and seal tissue, maximize the likelihood of the clamp arm electrode contacting tissue in restricted or difficult scenarios, such as, for example, thin tissue, tissue under lateral tension, tissue tenting / vertical tension, especially when tented tissue is distanced from the clamp arm.

[0143] In other aspects, the end effectors described herein are configured to enable balancing of the surface area / current density match between electrodes, balancing and minimizing heat conduction from tissue interfaces, such as for example, affecting lesion formation and symmetry, cycle time, residual thermal energy.

[0144] In other aspects, the end effectors described herein are configured to minimize adhesion, tissue sticking (minimize anchoring points) and can include small polyimide pads.

[0145] In various aspects, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a movable jaw, a flexible polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator, and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In various aspects, the end effector includes an electrode biasing mechanism.

[0146] In one general aspect, the present disclosure relates to a method of using a surgical device that includes a combination of ultrasonic and advanced bipolar RF energy and a movable RF electrode located on at least one jaw of an end effector. The movable RF electrode has a variable biasing force from a proximal end to a distal end of the movable RF electrode. The movable RF electrode is segmented into discrete portions and thus can be in electrical communication or isolated from one another. The movable RF electrode is made of a conductive or partially conductive material. It should be appreciated that any of the end effectors described in the present disclosure can be configured with an electrode biasing mechanism.

[0147] In one aspect, the present disclosure provides a limited electrode biasing mechanism to prevent damage to the electrode by the ultrasonic blade. Generally, in various aspects, the present disclosure provides an end effector for use with an ultrasonic / RF combination device, where the end effector includes an electrode. In one aspect, the combined ultrasonic / bipolar RF energy surgical device includes an electrode biasing mechanism. In one aspect, the limited electrode biasing mechanism is configured to prevent or minimize damage to the electrode by the ultrasonic blade. The electrode is fixed to the jaw at a proximal end and free to deflect at a distal end. Thus, throughout the present disclosure, the electrode can be referred to as a cantilevered beam electrode or a deflectable electrode.

[0148] In various aspects, the present disclosure provides a cantilevered electrode that is fixed at only one end that includes a biasing threshold mechanism. In one aspect, the deflectable cantilevered electrode is configured for use in a combined ultrasonic / bipolar RF energy surgical device.

[0149] In one aspect, a combined ultrasonic / RF energy surgical device includes an ultrasonic blade, a clamp arm, and at least one electrode passing through the ultrasonic blade. In one aspect, the electrode is configured to be deflectable relative to the clamp arm and includes a plurality of features for changing the mechanical properties of tissue under compression between the electrode and the ultrasonic blade. In another aspect, the electrode includes a feature that prevents accidental contact between the electrode and the ultrasonic blade to prevent or minimize damage to the electrode by the ultrasonic blade.

[0150] In various aspects, the electrode includes a metal spring element attached at a proximal end of a clamp jaw of an end effector. The metal spring element defines an opening for receiving one or more clamp arm pads (also referred to as "tissue pads" or "clamp tissue pads") therethrough and includes an integrated minimum gap element. This configuration of the electrode provides a method of preventing tissue buildup around the biasing mechanism, which can impact the performance of the electrode. The configuration also minimizes the binding between the wear pads and the biasing spring, enhances the strength of the electrode connection to the clamp arm, minimizes accidental release of the clamp arm pads by attaching the polyimide pads to the electrode, and achieves a balanced match of surface area / current density between the electrodes. The electrode is fixed to the clamp jaw at a proximal end and is free to deflect at a distal end. Thus, throughout this disclosure, the electrode is deflectable and can be referred to as a cantilevered beam electrode or deflectable electrode.

[0151] Figure 1 to Figure 9 One aspect of an end effector configured for use with a combined ultrasonic / bipolar RF energy device according to at least one aspect of the present disclosure is shown. The end effector includes a deflectable / cantilevered electrode. Figure 1 is a perspective view of a clamp arm 1000 portion of an end effector for use with a combined ultrasonic / RF device according to at least one aspect of the present disclosure. For brevity and clarity in the present disclosure, the ultrasonic blade, which serves as the other clamp arm of the end effector, is not shown. The end effector is configured such that the ultrasonic blade is one pole of a bipolar RF circuit and the clamp arm 1000 is the opposite pole. A consistent RF electrode gap is maintained between the clamp arm 1000 and the ultrasonic blade to prevent the ultrasonic blade from contacting the electrode, which can cause the blade to break or short. Tissue being treated is clamped and compressed between the clamp arm 1000 and the ultrasonic blade.

[0152] The clamp arm 1000 includes a frame 1002, an electrode 1004, at least one non-conductive small gap pad 1006, at least one non-conductive large gap pad 1008, at least one non-conductive clamp arm pad 1010. In one aspect, the small gap pad 1006 and the large gap pad 1008 are configured to enable setting a gap between the electrode 1004 and the ultrasonic blade. The clamp arm pad 1010 is configured to grasp tissue between the clamp arm 1000 and the ultrasonic blade to assist in sealing and cutting of the tissue. In other aspects, the non-conductive small gap pad and the non-conductive large gap pad are interchangeable. In other aspects, the non-conductive gap pads simply differ in size, regardless of the relative size difference between the non-conductive gap pads.

[0153] Pivoting movement of the clamp arm 1000 relative to the end effector is achieved by providing at least one (and preferably a pair of) lever portions 1012 of the frame 1002 of the clamp arm 1000 at its proximal end 1014. The lever portions 1012 are positioned on respective opposite sides of the ultrasonic waveguide and end effector and are in operable engagement with the drive portion of the reciprocating actuation member. Reciprocating movement of the actuation member relative to the outer tubular sheath and ultrasonic waveguide thereby effects pivoting movement of the clamp arm 1000 relative to the end effector about a pivot point 1016. The lever portions 1012 can be respectively positioned in a pair of openings defined by the drive portion, or otherwise suitably mechanically coupled therewith, whereby reciprocating movement of the actuation member acts through the drive portion and the lever portions 1012 to pivot the clamp arm 1000.

[0154] Figure 2 is in accordance with at least one aspect of the present disclosure Figure 1An exploded view of the clamp arm 1000 is shown. In various aspects, the electrode 1004 is made of a metal spring material that is attached to the proximal end 1014 of the frame 1002 of the clamp arm 1000 such that the electrode 1004 is deflectable. The metal spring electrode 1004 defines an opening 1018 for receiving an element of the clamp arm pad 1010 therethrough and defines additional openings 1020, 1021 for receiving gap pads 1006, 1008 to set a minimum gap between the electrode 1004 and the ultrasonic blade. At least one gap pad 1006 is disposed on a distal end 1022 of the electrode 1004. The gap pads 1006, 1008 are thus integrated with the electrode 1004. In this configuration, the electrode 1004 prevents tissue from accumulating around the biasing mechanism (e.g., cantilever spring), which can affect the performance of the electrode 1004. This configuration also minimizes the wear of the joint between the clamp arm pad 1010 and the biasing spring electrode 1004, enhances the strength of the electrode 1004 connection to the clamp arm, minimizes accidental release of the clamp arm pad 1018 by attaching the gap pads 1006, 1008 to the electrode 1004, and achieves a balanced match of surface area / current density between the electrodes. The electrode 1004 is attached to the frame 1002 by two tabs 1024. As Figure 3 and Figure 4 shown, the electrode tabs 1024 are attached to the proximal end 1014 of the frame 1002.

[0155] Figure 3 and Figure 4 are perspective views of the frame 1002 according to at least one aspect of the present disclosure. These figures show the connection surface 1026 on the proximal end 1014 of the frame 1002 for attaching the proximal end of the electrode 1004 to the frame 1002. In one aspect, the electrode tabs 1024 are welded to the connection surface 1026 of the frame 1002 such that the electrode 1004 works in a deflectable manner.

[0156] Figure 5 is a perspective view of the electrode 1004 according to at least one aspect of the present disclosure. This figure shows the bias in the electrode 1004 made of a spring material as shown by the curvature of the electrode 1004 along the longitudinal length. The openings 1018, 1020, 1021 are for receiving the gap pads 1006, 1008 and the clamp arm pad 1010. In one aspect, the electrode 1004 has a thickness "d" of 0.010" and can be selected within a range of thicknesses of, for example, 0.005" to 0.015". Reference is additionally made to Figure 8 and Figure 9 the size and configuration of the opening 1020 is set to receive the tab 1036 defined on the bottom portion of the gap pad 1006.

[0157] Figure 6is a perspective view of a clamp arm pad 1010 according to at least one aspect of the present disclosure. The clamp arm pad 1010 includes a plurality of clamp arm elements 1032 protruding from a main stem 1030. Throughout the present disclosure, the clamp arm elements 1032 are also referred to as "teeth." In one aspect, the clamp arm pad 1010 defines an aperture 1028 in a position where the gap pad 1006 is located on the electrode 1004. Reference is additionally made to Figure 8 and Figure 9 The size and configuration of the aperture 1028 defined by the clamp arm pad 1010 is set to receive the protrusion 1036 defined on the bottom portion of the gap pad 1006. In one aspect, the material of the clamp arm pad 1010 is softer than the material of the gap pads 1006, 1008. In one aspect, the clamp arm pad 1010 is made of a non-stick lubricious material, such as polytetrafluoroethylene (PTFE) or similar tetrafluoroethylene synthetic fluoropolymer. PTFE is a hydrophobic, non-wetting, high-density, and high-temperature-resistant, multi-purpose material and has non-stick properties. In contrast, the gap pads 1006, 1008 are made of a polyimide material, and in one aspect, for example, a durable high-performance polyimide-based plastic known by the trade name VESPEL and manufactured by DuPont, or other suitable polyimide, polyimide polymer alloy, or PET (polyethylene terephthalate), PEEK (polyether ether ketone), PEKK (polyether ketone ketone) polymer alloy. Unless otherwise noted below, the clamp arm pads and gap pads described below are made of the materials described in this paragraph.

[0158] Figure 7 is a perspective top view of a large gap pad 1008 according to at least one aspect of the present disclosure. The large gap pad 1008 includes a protrusion 1034 sized and configured to fit within an opening 1021 at the proximal end 1014 of the electrode 1004. Figure 8 is a perspective top view of a small gap pad 1006 according to at least one aspect of the present disclosure. Figure 9 is Figure 8 a perspective bottom view of the small gap pad 1006 as shown. As shown in Figure 8 and Figure 9 The small gap pad 1006 includes a protrusion 1036 at the bottom portion sized and configured to be received within the opening 1020 defined by the electrode 1004 and the aperture 1028 defined by the clamp arm pad 1010. The small gap pad 1006 and the large gap pad 1008 are made of a polyimide material, and in one aspect, a durable high-performance polyimide-based plastic known by the trade name VESPEL and manufactured by DuPont. The durability of the polyimide material ensures that the electrode gap remains relatively constant under normal wear and tear.

[0159] In one aspect, the present disclosure also provides additional end effector configurations for a combined ultrasonic and bipolar RF energy device. This section of the present disclosure provides end effector configurations for a combined ultrasonic and bipolar RF energy device. In these configurations, the end effector maintains a consistent gap between the RF electrode gap and the ultrasonic blade (which serves as one pole of the bipolar RF circuit) and the clamp arm (which serves as the opposite pole of the bipolar RF circuit). In traditional end effector configurations, the electrode gap is set by a soft PTFE clamp arm pad that can wear out during a procedure. When the clamp arm pad wears through, the ultrasonic blade can contact the electrode, resulting in blade breakage or electrical shorting, both of which are undesirable.

[0160] To overcome these and other limitations, aspects of the present disclosure employ a combination of a deflectable RF electrode and a clamp arm pad comprising a non-stick, lubricious flexible (e.g., PTFE) pad fixed to the clamp arm. The RF electrode comprises a wear resistant, non-conductive pad that contacts the blade to set the blade-electrode gap. The flexible clamp arm pad extends through an opening defined by the electrode and reacts to clamping forces from the ultrasonic blade. As the flexible clamp arm pad wears out, the electrode deflects to maintain a consistent gap between the blade and the electrode. This configuration provides a consistent gap between the electrode and the ultrasonic blade throughout the life of the device, prevents shorting and ultrasonic blade breakage that can occur when the ultrasonic blade contacts the electrode, and enables the electrode material to be positioned directly on the side opposite the ultrasonic blade to improve sealing performance. The electrode is fixed to the clamp jaw at the proximal end and is free to deflect at the distal end. Accordingly, throughout the present disclosure, the electrode can be referred to as a cantilevered beam electrode or a deflectable electrode.

[0161] In one aspect, the present disclosure provides an asymmetric fit of the clamp arm / electrode / pad to enable ultrasonic blade-RF electrode interaction. In one aspect, the present disclosure provides a shortened clamp arm. Figure 10 to Figure 12 An end effector comprising a shortened clamp arm suitable for deflectable / cantilevered electrode applications is shown in accordance with various aspects of the present disclosure. In one aspect, the end effector is configured for an asymmetric fit of the clamp arm, electrode, and clamp arm pad to enable ultrasonic blade / RF electrode interaction. The electrode is suitable for and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflecting under load, where the electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0162] In one aspect, the distal end of the clamp arm is shortened and the length of the clamp arm pad remains the same length such that the distal end of the clamp arm pad extends beyond the distal end of the clamp arm. This will allow the electrode to overextend to minimize the potential for electrical shorting at the distal end of the clamp arm. This can also have the beneficial effect of extending the life of the clamp arm pad as the otherwise exposed clamp arm pad material will be abraded away. This configuration can also eliminate the use of a distal and intermediate gap setting clamp arm pad, which has been previously referred to herein as, for example, an abradable clamp arm pad, for setting and maintaining a gap between the electrode and the ultrasonic blade.

[0163] Figure 10 is a side view of an end effector 1680 including a shortened clamp arm 1682, an ultrasonic blade 1684, an electrode 1686, and a clamp arm pad 1688 according to at least one aspect of the present disclosure. Figure 11 is a top view of the end effector 1680. As Figure 10 to Figure 11 shown, the length of the ultrasonic blade 1684 and the electrode 1686 are substantially the same. The clamp arm 1682 is shortened to allow the electrode 1686 to overextend to prevent electrical shorting. In one aspect, a gap setting pad 1690 is provided at the proximal end 1692 of the end effector 1680.

[0164] Figure 12 is shown a clamp arm 1700 including a clamp jaw 1702, an electrode 1704, and a clamp arm pad 1706 according to at least one aspect of the present disclosure. The distal space of the clamp arm is freed up. The clamp arm 1700 is configured for use with an end effector including an ultrasonic blade as disclosed in other sections herein. This configuration frees up the distal space 1708 on the clamp jaw 1702. The clamp arm pad 1706 (e.g., PTFE) is fully supported underneath, but the space in the t-slot region and on the sidewalls is freed up to allow more of the clamp arm pad 1706 to burn through and the electrode 1704 to deflect further away from the ultrasonic blade (not shown).

[0165] In one aspect, the present disclosure provides an end effector that utilizes the thermal behavior of a pad to deflect an electrode. In one aspect, the length of the clamp arm pad can be the same length as the length of the ultrasonic blade, and as the clamp arm pad expands or changes shape due to pressure or heat, the thermal expansion properties of the clamp arm pad material (e.g., PTFE) can be used to deflect the electrode out of the path of the ultrasonic blade.

[0166] In one aspect, a non-biased electrode and pad are provided. As the pad wears, the non-biased but deflectable pad changes position relative to the clamp arm. The non-biased electrode is configured to enable minimization of contact between the ultrasonic blade and the RF electrode. The clamp arm pad includes features for securing the electrode to the clamp arm pad. In one aspect, as the height of the clamp arm pad wears or is cut through, the height of the electrode relative to the clamp arm is adjusted in a progressive manner. In another aspect, once the clamp arm is moved away from the ultrasonic blade, the electrode remains in its new position. The electrode is fixed to the clamp arm at the proximal end and free to deflect at the distal end. Thus, throughout this disclosure, the electrode can be referred to as a cantilevered electrode or deflectable electrode.

[0167] The end effector configurations described above with respect to Figure 1 to Figure 12 the deflectable / cantilevered electrode can be combined with the biased electrode described below with respect to Figure 13 to Figure 18 In one aspect, the present disclosure provides an end effector for a combined ultrasonic / bipolar RF energy surgical device that employs pressure or clamp compression to adjust the height of the electrode as the clamp arm pad wears. In one aspect, the clamp arm pad follows a clamp arm biased electrode with a wear stop. In one aspect, the clamp arm pad includes features for securing the electrode to the pad. As the height of the pad wears or is cut through, the height of the electrode relative to the clamp arm is adjusted in a progressive manner. Once the clamp arm is moved away from the ultrasonic blade, the electrode remains in its new position.

[0168] Achieving sufficient clamp arm pad life on a combined ultrasonic / bipolar RF energy surgical device requires maintaining a clamp arm pad-electrode gap that is sufficiently small but non-zero throughout the life of the instrument to provide the desired ultrasonic and bipolar RF tissue effects. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflecting under load, where the electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0169] The existing (seed) electrode is a flat electrode that is actually horizontal or parallel to the clamp arm in the free state (no load). The electrode is fixed to the clamp arm at the proximal end and free to deflect at the distal end. Thus, throughout this disclosure, the electrode can be referred to as a cantilevered electrode or deflectable / cantilevered electrode. When clamped on tissue, the tissue exerts a load on the electrode, causing it to deflect toward the clamp arm.

[0170] In one aspect, as the pad wears, the electrode "follows" the pad. In this aspect, the electrode is biased toward the free state of the clamp arm using any suitable fastening technique, such as welding, laser welding, brazing, soldering, pressing, and other fastening techniques (whether by forming / bending the electrode, or by attaching / welding the electrode non-parallel to the clamp arm). Worn stop features (on the pad or elsewhere) keep the electrode away from the clamp arm until they are worn away during use. Once worn away, the electrode is able to access the clamp arm. These features can be tooth or ratchet shaped, vertical tapering, or other.

[0171] In one aspect, the present disclosure provides a deflectable / cantilevered electrode, where in the free state, the electrode is biased toward the clamp arm and can be attached at an angle and made into a pre-shaped curve using any suitable fastening technique, such as welding, laser welding, brazing, soldering, pressing, and other fastening techniques.

[0172] In one aspect, the present disclosure provides an end effector with a deflectable / cantilevered electrode that includes a wear-away stop feature to prevent the electrode from reaching or contacting the clamp arm. As the stop feature wears away, the electrode moves toward the clamp arm until it reaches the next stop. In one aspect, the stop feature wears away simultaneously with the clamp arm pad to maintain the proper gap between the clamp arm pad and the electrode. These features can be completely separate from the clamp arm pad. These features can be configured to withstand the clamp load but be worn away due to heat (melting / flowing) or abrasion. Possible examples include teeth on one or more clamp arm pads (PTFE, polyimide, or other) and a tapered profile on one or more clamp arm pads (PTFE, polyimide, or other).

[0173] Figure 13 An end effector clamp arm 1710 including a jaw 1712, an electrode 1714, and a clamp arm pad 1716 is shown in accordance with at least one aspect of the present disclosure. The clamp arm 1710 is configured for use with an end effector including an ultrasonic blade (not shown) as described throughout the present disclosure. The clamp arm 1710 further includes a wear gap pad 1717 to set a gap between the electrode 1714 and the ultrasonic blade. As shown, in the free state, the electrode 1714 is biased in a flat or horizontal orientation 1718. The electrode 1714 is fixed to the jaw 1712 at a proximal end and is free to deflect at a distal end. Accordingly, throughout the present disclosure, the electrode 1714 can be referred to as a cantilevered beam electrode or a deflectable electrode.

[0174] Figure 14An end effector clamp arm 1720 including a clamp jaw 1722, an electrode 1724, and a clamp arm pad 1726 is shown in accordance with at least one aspect of the present disclosure. The clamp arm 1720 is configured for use with an end effector including an ultrasonic blade (not shown) as described throughout the present disclosure. The clamp arm 1720 further includes a wear gap pad 1727 to set a gap between the electrode 1724 and the ultrasonic blade. As shown, in a free state, the electrode 1724 is configured to be pre-shaped, curved, or otherwise biased away from the horizontal 1718 along a line 1728 toward the clamp jaw 1722. The electrode 1724 is fixed to the clamp arm 1720 at a proximal end and is free to deflect at a distal end. Accordingly, throughout the present disclosure, the electrode 1724 can be referred to as a cantilevered beam electrode or a deflectable electrode. To prevent the biased electrode 1724 from bending toward the clamp jaw 1722 under the biasing force, the clamp arm 1720 further includes a retainer to prevent the biased electrode 1724 from bending toward the clamp jaw 1722 and to maintain the biased electrode 1724 in a generally flat configuration (e.g., parallel, flat, or horizontal) relative to the ultrasonic blade. Examples of retainers, such as retainer teeth 1738 and retainer walls 1760 having a tapered profile, are described below in Figure 15 to Figure 18

[0175] Figure 15 An end effector clamp arm 1730 including a clamp jaw 1732, an electrode 1734, and a clamp arm pad 1736 is shown in accordance with at least one aspect of the present disclosure. The clamp arm 1730 is configured for use with an end effector including an ultrasonic blade (not shown) as described throughout the present disclosure. The clamp arm 1730 further includes a wear gap pad 1737 to set a gap between the electrode 1744 and the ultrasonic blade. In a free state, the electrode 1734 is configured to be pre-shaped curved, bent, or otherwise biased toward the clamp jaw 1732. However, retainer teeth 1738 or similar features are provided on the clamp arm pad 1736 to prevent the electrode 1734 from snapping toward the clamp jaw 1732. In Figure 16

[0176] Figure 17 ​​An end effector clamp arm 1750 including a clamp jaw 1752, an electrode 1754, and a clamp arm pad 1756 is shown in accordance with at least one aspect of the present disclosure. The clamp arm 1750 is configured for use with an end effector including an ultrasonic blade (not shown) as described throughout the present disclosure. The clamp arm 1750 further includes a wear gap pad 1757 to set a gap between the electrode 1754 and the ultrasonic blade. In a free state, the electrode 1754 is configured to be pre-shaped with a curve, kinked, or otherwise biased 1758 toward the clamp jaw 1752. However, a retainer wall 1760 or similar feature with a tapered profile is provided on the clamp arm pad 1756 to prevent the electrode 1754 from springing in toward the clamp jaw 1752.

[0177] In Figure 17 In accordance with at least one aspect of the present disclosure, when the tapered profile retainer wall 1760 is worn away, there is sufficient melt / flow away from the area of the tapered profile retainer wall 1760 to allow the electrode 1754 to move toward the clamp jaw 1752 due to the pre-shaped curve. The electrode 1754 is fixed to the clamp jaw 1752 at a proximal end and free to deflect at a distal end. Accordingly, throughout the present disclosure, the electrode 1754 can be referred to as a cantilevered beam electrode or deflectable electrode.

[0178] In one aspect, the present disclosure provides an end effector for a combined ultrasonic / bipolar RF energy surgical device that employs a constant pressure distribution biasing mechanism. In one aspect, the end effector includes a resiliently compressible support for mounting a deflectable electrode and insulating the deflectable electrode. In one aspect, a hollow honeycomb or chambered elastomeric support attachment pad can be employed to allow all or part of the electrode attached thereto to deflect but be biased toward the ultrasonic blade. This configuration can provide the additional benefit of thermally insulating the electrode from the rest of the metal clamp jaw. This will also provide an elastomeric "curtain" around the electrode to minimize tissue build-up behind the electrode. In one aspect, the non-strutted elastomeric unit adapted deflectable geometry will cause the deflection force to remain constant over a predetermined deflection range. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflecting under load, where the electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0179] The above configuration prevents the electrode from laterally deflecting under compression to prevent shorting. In addition, the deflectable electrode is attached to an elastomer and the elastomer is attached to a metal clamp arm. The physical height of the spring is limited by the amount of compression allowed by the drive, while maintaining as much metal clamp arm as possible. Heat conduction from the tissue interface is balanced and minimized - affecting lesion formation and symmetry, cycle time, and residual thermal energy.

[0180] The above configuration prevents the electrode from laterally deflecting under compression to prevent shorting. In addition, the deflectable electrode is attached to an elastomer and the elastomer is attached to a metal clamp arm. The physical height of the spring is limited by the amount of compression allowed by the drive, while maintaining as much metal clamp arm as possible. Heat conduction from the tissue interface is balanced and minimized - affecting lesion formation and symmetry, cycle time, and residual thermal energy.Figure 1 to Figure 12 The configuration of the end effector described above with respect to Figure 19 to Figure 21 may be combined with a flexible electrode disposed above a mesh spacer and a plurality of hard spacers to set a gap between the flexible electrode and the ultrasonic blade as described below with respect to .

[0181] The configuration of the bias electrode described above with respect to Figure 13 to Figure 18 may be combined with a flexible electrode disposed above a mesh spacer and a plurality of hard spacers to set a gap between the flexible electrode and the ultrasonic blade as described below with respect to Figure 19 to Figure 21 .

[0182] The configuration of the end effector comprising the combination of the deflectable / cantilevered electrode described above with respect to Figure 1 to Figure 12 and the bias electrode described above with respect to Figure 13 to Figure 18 may be combined with a flexible electrode disposed above a mesh spacer and a plurality of hard spacers to set a gap between the flexible electrode and the ultrasonic blade as described below with respect to Figure 19 to Figure 21 .

[0183] Figure 19 to Figure 20 An end effector 1810 is shown in accordance with at least one aspect of the present disclosure comprising a clamp arm 1812, an ultrasonic blade 1814, a mesh spacer 1816, a flexible electrode 1818 disposed above the mesh spacer 1816, and a plurality of hard spacers 1820 to set a gap between the flexible electrode 1818 and the ultrasonic blade 1814. Figure 21 is Figure 19 to Figure 20 an exploded view of the end effector 1810. A clamp arm pad 1822 is disposed within a slot 1825 formed within the mesh spacer 1816. The mesh spacer 1816 acts as a spring-like element. The hard spacers 1820 are used to set the gap between the flexible electrode 1818 and the ultrasonic blade 1814.

[0184] In Figure 19 , the clamp arm 1812 is open and the tissue 1824 of uneven thickness (T 1a , T 2a , T 3a ) is disposed above the flexible electrode 1818. In Figure 20 , the clamp arm 1812 is closed to compress the tissue 1824. The mesh spacer 1816 on the clamp arm 1812 results in uniform tissue 1824 (T 1b , T 2b , T 3b ) compression on the tissue 1824 of variable thickness (T 1a , T 2a , T 3a ) such that:

[0185]

[0186] Further background art disclosures can be found in EP 3378427, WO 2019 / 006068, which are incorporated herein by reference in their entirety.

[0187] In one aspect, the present disclosure provides an end effector for a combined ultrasonic / bipolar RF energy surgical device having means for ensuring distal tip contact with bias using a zero-gap bipolar RF energy system. In various aspects, the present disclosure provides a deflectable electrode for a combined ultrasonic / bipolar RF energy surgical device having more distal bias than proximal bias. In one aspect, the present disclosure provides a combined energy device including a bipolar electrode that is deflectable relative to a clamp arm. The combined energy device includes features that change the mechanical properties of proximal to distal tissue compression to create a more uniform or different pressure pattern than that created by clamping alone. In one aspect, the present disclosure provides a non-linear distal distribution mechanism and in another aspect, an electrical non-linear distribution of energy density. 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 blade is the opposite pole of the bipolar RF circuit.

[0188] The configurations of deflectable / cantilevered electrodes described above in relation to Figure 1 to Figure 12 may be combined with the conductive polymer clamp arm pads described below in relation to Figure 22 to Figure 36 .

[0189] The configurations of biased electrodes described above in relation to Figure 13 to Figure 18 may be combined with the conductive polymer clamp arm pads described below in relation to Figure 22 to Figure 36 .

[0190] The configurations of flexible electrodes disposed above a mesh pad and a plurality of hard spacers to set a gap between the flexible electrode and the ultrasonic blade described above in relation to Figure 19 to Figure 21 may be combined with the conductive polymer clamp arm pads described below in relation to Figure 22 to Figure 36 .

[0191] The configurations of biased electrodes described above in relation to Figure 13 to Figure 18 may be combined with flexible electrodes disposed above a mesh pad and a plurality of hard spacers to set a gap between the flexible electrode and the ultrasonic blade described above in relation to Figure 19 to Figure 21 may be combined with the conductive polymer clamp arm pads described below in relation to Figure 22 to Figure 36 .

[0192] The configurations of deflectable / cantilevered electrodes described above in relation to Figure 13 to Figure 18The configuration of the bias electrode can be combined with a flexible electrode disposed above the grid pad, and as described above regarding Figure 19 to Figure 21 The plurality of rigid spacers used to create a gap between the flexible electrode and the ultrasonic scalpel can be related to the following text. Figure 22 to Figure 36 The aforementioned conductive polymer clamping arm pad assembly.

[0193] Including the above about Figure 1 to Figure 12 The deflectable / cantilever electrode mentioned above is related to the above. Figure 13 to 18 The configuration of the end effector with the aforementioned combination of bias electrodes is similar to that described below regarding... Figure 22 to Figure 36 The aforementioned conductive polymer clamping arm pad assembly.

[0194] Including the above about Figure 1 to Figure 12 The deflectable / cantilever electrode mentioned above is related to the above. Figure 13 to Figure 18 The configuration of the end effector with the aforementioned combination of bias electrodes can be combined with flexible electrodes disposed above the mesh pad, and as described above regarding Figure 19 to Figure 21 The plurality of rigid spacers used to create a gap between the flexible electrode and the ultrasonic scalpel can be related to the following text. Figure 22 to Figure 36 The aforementioned conductive polymer clamping arm pad assembly.

[0195] 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.

[0196] In one aspect, this disclosure provides an end effector for a combined ultrasound / bipolar RF energy surgical device, the end effector comprising a conductive polymer ultrasound gripping arm pad. In another aspect, the end effector comprises a gripping arm pad doped with tin oxide. Figure 22is a cross-sectional view of a conductive polymer clamp arm pad 2440 according to at least one aspect of the present disclosure. The conductive polymer clamp arm pad 2440 includes tin oxide 2442 (Sn02) embedded in a polymer material 2444, such as polytetrafluoroethylene (PTFE), to make the clamp arm pad 2440 electrically conductive. Doping can be achieved using a cold spray process. Once doped, the conductive polymer clamp arm pad 2440 can achieve traditional ultrasonic tissue clamp arm pad functions, such as, for example, contacting the ultrasonic blade, absorbing heat from the ultrasonic blade, and assisting in tissue grasping and clamping. The doped tin oxide clamp arm pad 2440 functions as one of the two electrodes or poles of a bipolar RF circuit to deliver RF energy to tissue grasped between the ultrasonic blade and the clamp arm pad 2440. The doped tin oxide clamp arm pad 2440 is biocompatible, electrically conductive, thermally conductive, such that a majority of the clamp arm pad 2440 can be used to improve the wear resistance of the clamp arm pad 2440, and is white. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load, where the electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0197] In one aspect, the present disclosure provides a conductive polymer ultrasonic clamp arm pad as an electrode substitute. To extend the life of an ultrasonic clamp arm pad and improve RF tissue effects, the present disclosure provides an improved, easier to manufacture, and less expensive electrode. In one aspect, the present disclosure provides a clamp arm pad comprising a hard polyimide polymer layer and a conductive layer to allow the clamp arm pad to achieve traditional functions and carry bipolar electricity, thereby combining the clamp arm of an energy end effector no longer requires a separate electrode. As such, the forceps can be manufactured in a manner similar to a pure ultrasonic forceps, where the new clamp arm pad material is interchangeable with a traditional pure ultrasonic clamp arm pad. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load, where the electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0198] Benefits include improved ultrasonic performance, including clamp arm pad wear, similar to current pure ultrasonic instruments, as there are no electrode gaps between the elements "squares" of polymer. The cost of the improved forceps will be similar to current pure ultrasonic forceps due to the elimination of a separate electrode component and the provision of multiple small polymer square elements. Additionally, the manufacturing steps required to manufacture the forceps are the same as those required to manufacture current pure ultrasonic forceps. Manufacturing the improved forceps only requires replacement of the clamp arm pad and does require production of additional electrode components to add to the forceps and eliminates an assembly step.

[0199] Figure 23is a perspective view of a clamp arm pad 2450 configured to be able to replace a conventional electrode according to at least one aspect of the present disclosure. The clamp arm pad 2450 includes a sandwiched configuration of a non-conductive layer 2452 and a conductive layer 2454. This configuration eliminates the need for a spring-loaded electrode plate. The non-conductive layer 2452 can be made of a polymer, polyimide, polytetrafluoroethylene (PTFE), and similar non-conductive materials. The conductive layer 2454 can be made of a thin conductive polymer, a metal foil, or a carbon-loaded material. The clamp arm pad 2450 can be manufactured such that a majority of the material that contacts the ultrasonic blade is the non-conductive layer 2452. In one aspect, 75% of the material that contacts the ultrasonic blade is a non-conductive material, such as PTFE. In another aspect, 85% of the material that contacts the ultrasonic blade is a non-conductive material, such as PTFE. In another aspect, 95% of the material that contacts the ultrasonic blade is a non-conductive material, such as PTFE. Additionally, as the clamp arm pad 2450 wears, the conductive layer 2452 will still have available surface area to conduct RF power through the tissue and return electrode (e.g., ultrasonic blade).

[0200] Figure 24 is shown a clamp arm 2460 including the clamp arm pad 2450 as described according to at least one aspect of the present disclosure. In the illustrated clamp arm 2460, the non-conductive layer 2452 has a large surface area as compared to the conductive layer 2454 which appears as a thin layer or foil. Figure 23

[0201] Figure 25 is shown a clamp arm pad as constructed as described in Figure 23 to Figure 24 . The first clamp arm pad 2470 is new and includes teeth 2472 integrally formed therewith. The second clamp arm pad 2476 is new but does not have teeth. The third clamp arm pad 2478 is worn and can represent either the first clamp arm pad 2470 or the second clamp arm pad 2476.

[0202] In one aspect, the present disclosure provides a composite clamp arm pad for a combined ultrasonic / bipolar RF energy surgical device. Figure 26 ​is a cross-sectional view of a clamp arm 2480 including a composite clamp arm pad 2482 in contact with tissue 2484 according to at least one aspect of the present disclosure. The end effector 2480 includes an upper jaw 2486 and an adhesive 2488 to fixedly attach the composite clamp arm pad 2482 to the upper jaw 2486. The composite clamp arm pad 2482 includes a thin electrically non-conductive layer 2490 (e.g., PTFE) and a thin electrically conductive layer 2492 (e.g., thin stainless steel foil). The electrically conductive layer 2492 forms an electrode portion of the composite clamp arm pad 2482. As the electrically non-conductive layer 2490 (e.g., PTFE) is worn away, the electrically conductive layer 2492 (e.g., thin stainless steel foil) deforms. The thickness of the electrically conductive layer 2492 enables the electrode portion of the composite clamp arm pad 2482 to deform as the electrically non-conductive layer 2490 is worn away. Advantageously, the electrically conductive layer 2492 conducts some heat away from the electrically non-conductive layer 2490 to keep the composite clamp arm pad 2482 cooler. As described above, the composite clamp arm pad 2482 is fixed to the upper jaw 2486 by the adhesive 2488. The adhesive 2488 can be filled with carbon to make it electrically conductive and connect the electrode portion of the composite clamp arm pad 2482 to the upper jaw 2486. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflecting under a load, where the electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0203] In one aspect, the clamp arm pad includes a cooperating electrically conductive portion and an insulating portion. In one aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device, where the clamp arm pad has an electrically conductive portion and an electrically non-conductive portion, allowing it to function as one of the RF electrodes, while also functioning as an abradable support structure for the ultrasonic blade. In another aspect, the electrically conductive portion of the clamp arm pad is disposed around the periphery of the pad and is not positioned directly on the side opposite the area of contact with the ultrasonic blade. In another aspect, the electrically conductive portion of the clamp arm pad is degradable or abradable to prevent interruption of the electrical conductivity of the remaining electrically conductive portion of the clamp arm pad in contact with the ultrasonic blade.

[0204] In one aspect, the present disclosure provides a clamp arm pad for use with a combined ultrasonic / bipolar RF energy device, where a portion of the clamp arm pad includes an electrically conductive material and other portions include electrically non-conductive material. The electrode is adapted and configured for use with a combined ultrasonic / RF energy device and is capable of deflecting under a load, where the electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0205] 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.

[0206] 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.

[0207] 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.

[0208] 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.

[0209] 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.

[0210] 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.

[0211] 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.

[0212] The conductive element 2546 can be made of a conductive metal such as stainless steel or similar conductive material. The conductive element 2546 can be about 0.010" thick and can be selected within a range of 0.005" to 0.015" thick and can be formed by ramming or machining. The film 2544 can be about 0.001" to 0.002" thick and can be made of polyimide, polyester or similar material. The film 2544 can be bonded directly to the conductive element 2546 as an alternative to mechanical retention such as a post. One example includes a DuPont Pyralux HXC Kapton film with epoxy adhesive backing that is 0.002" thick.

[0213] Advantageously, the non-stick surface prevents tissue adhesion to the insert molded electrode 2540. By providing a gap in the range of 0.002" to 0.004" along the entire length of the insert molded electrode 2540, the non-stick surface avoids shorting of the opposing electrode. The non-stick surface minimizes lateral propagation of RF energy due to the coverage of the sidewall 2558 of the insert molded electrode 2540. In addition, the insert molded electrode 2540 exhibits structural robustness and provides an easier and more robust electrical connection than a multi-layer flexible circuit.

[0214] In one aspect, the end effector includes a conductive clamp arm and pad configuration for a combined ultrasonic / bipolar RF energy surgical device. In one aspect, the present disclosure provides a clamp arm assembly including a conductive or selectively conductive film, foil or laminate applied to, around or on the clamp arm assembly for use as a durable "pole" in a combined ultrasonic / bipolar RF energy surgical device. Further, an algorithm, software or logic is provided to manage the condition of electrical shorting. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflection under load, wherein the electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposing pole of the bipolar RF circuit.

[0215] Figure 33 An end effector 2560 including an ultrasonic blade 2562, a clamp arm 2564 and a clamp arm pad 2566 containing a conductive film 2568 is shown in accordance with at least one aspect of the present disclosure.

[0216] Figure 34 An end effector 2560 including an ultrasonic blade 2562, a clamp arm 2564 and a clamp arm pad 2566 containing a conductive film 2568 is shown in accordance with at least one aspect of the present disclosure. Figure 33 The clamp arm 2564 is shown. The clamp arm 2564 includes a jaw 2570 to support the clamp arm pad 2566. A thin conductive film 2568 is disposed on the clamp arm pad 2566 to form an electrode of one of the poles of a bipolar RF circuit.

[0217] Figure 35 is along Figure 34A cross-sectional view of the clamp arm 2564 taken at section 35-35 in FIG. 35. The clamp jaw 2570 can be made of a metal such as stainless steel. The clamp arm pad 2566 can be made of a non-conductive flexible material such as PTFE, silicone, high temperature polymer, or similar material. The conductive film 2568 or foil can be made of a conductive material such as titanium, silver, gold, aluminum, zinc, and any alloys thereof, including stainless steel.

[0218] Figure 36 A clamp arm 2580 including a partially conductive clamp arm pad 2582 is shown in accordance with at least one aspect of the present disclosure. A conductive foil 2584 covers a portion of a non-conductive pad 2586. A non-conductive pad 2588 at a proximal end 2590 provides a gap between the clamp arm pad 2582 and the ultrasonic blade.

[0219] The conductive film 2568, foil, or laminate element can comprise, for example, a single layer of thin conductive material such as a metal (titanium, silver, gold, zinc, aluminum, magnesium, iron, etc. and alloys or stainless steel thereof), a plated metal (e.g., nickel first, then gold over copper), or a polymer heavily filled with a conductive material such as a metal powder or filler. Preferably, it is a biocompatible metal foil having a thickness selected from the range of 0.001" to 0.008" (0.025 mm to 0.20 mm), such as titanium, silver, gold, zinc, or stainless steel.

[0220] The film 2568, foil, or laminate can include a thin polymer coating, film, or layer overlying the thin conductive material described above. Such a coating, film, or layer is highly resistive, i.e., it is not an effective conductor of bipolar RF energy to adjacent tissue. The coating can be perforated to allow energy to be delivered from the electrode to tissue.

[0221] The conductive material can be perforated or include holes or windows through the full thickness of the conductive material to minimize the thermal capacity of the layer (testing has shown that long and / or thick foils result in longer transection times due to the removal of thermal energy from the treatment line of sight). These perforations, holes, or windows can also allow the foil to be held to other portions or layers. These perforations, holes, or windows can be patterned across the foil sheet, or can be positioned at or away from the treatment site, such as, for example, only on the sides of the clamp arm.

[0222] The thin polymer coating, film, or layer, if present, can be perforated or include holes or windows through the full thickness such that the conductive film, foil, or laminate is in direct communication with tissue for delivery of bipolar radiofrequency energy to the tissue. For a coating, these holes or windows can be formed by selective coating or coating removal.

[0223] Ideally, the conductive film 2568, foil, or laminate is in direct contact with the clamp arm structure, which is typically fabricated from stainless steel. The resulting conductive path then enables simplicity of construction, as the path is formed by the necessary structural components, i.e., the support tube or actuator that is directly connected to the clamp arm and then to the conductive film, foil, or laminate.

[0224] In one aspect, the conductive film 2568, foil, or laminate is supported by a relatively soft, high temperature, low wear polymer or elastomeric pad made from materials such as PTFE, silicone, polyimide, high temperature thermoplastics, and others. The compliance of this relatively soft pad allows for a wide range of component tolerances to achieve zero or near zero gap between the clamp and ultrasonic blade along its entire tissue-acting length when the clamp is fully closed, enabling sealing and cutting of tissue along that length. Compliance also eliminates or greatly attenuates any audible vibrations of the conductive layer that can occur when the ultrasonic blade is in close proximity to the conductive layer.

[0225] The conductive film 2568, foil, or laminate can include a rigid to semi-rigid polymer on its backside / back surface (i.e., the surface that is away from the tissue and toward the clamp arm). This component is made from a polymer or polymer alloy that can be injection molded and adhered to the film, foil, or laminate by film insert molding (FIM) or in-mold labeling (IML).

[0226] In testing, thin stainless steel, copper, or aluminum foil was quiet (no "squealing" or emitting a dull squeal) in operation. Thin stainless steel, copper, or aluminum foil provided a solid surface against which the ultrasonic blade could act. Solid enough that materials such as silicone rubber, which would otherwise tear and serve as a poor pad material, were usable and not prone to tearing or splitting.

[0227] The proximal portion of the clamp gripping surface can not include a conductive film, foil, or laminate, as this area of the clamp first contacts the blade and is more likely to cause a power shunt / short in this area.

[0228] In one aspect, the present disclosure provides a short circuit mitigation algorithm for activating an output comprising bipolar RF energy.

[0229] A short circuit alert is not given to the user after a short circuit occurs if the energy delivered for activation exceeds a threshold amount (indicating tissue thinning but possibly having received a sufficient dose of bipolar RF energy for sealing, coagulation of tissue), or an activation time threshold has been exceeded (again, indicating tissue thinning but possibly having received a sufficient dose), or both the energy threshold and the activation time threshold have been exceeded.

[0230] The process of making a film-coated stainless steel insert molded electrode assembly includes: etching the film and forming holes (micropores, slots, or honeycombs) for the transmission of RF energy; cutting the perimeter of the electrode component; forming the film on the stainless steel electrode if needed / bonding the film to the stainless steel electrode; placing the charged film and electrode in a polymer injection mold; molding the polymer to the back of the electrode and film.

[0231] In various aspects, the present disclosure provides an end effector for a combined ultrasonic / bipolar RF energy surgical device, the end effector comprising an electrode support mechanism. In one aspect, the electrode support mechanism is configured to prevent delamination of the electrode from the clamp arm. In one aspect, the electrode is attached to the clamp arm with a continuous adhesive to prevent accidental shedding of the flexible electrode from the clamp arm. In one aspect, the present disclosure provides a flexible electrode adhered to a mechanical support member as described herein. The support member can be a metal-plastic hybrid with integrated hinges to minimize the likelihood of the structural mechanical support member separating from the clamp arm. Delamination can occur between the structural mechanical support member and the electrode member. The electrode member is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is capable of deflection under load, wherein the electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0232] Figure 37 A clamp arm 1850 is shown including a jaw 1852, a support with a hinge-like feature 1854, an electrode 1856, and a clamp arm pad 1858, in accordance with at least one aspect of the present disclosure. The clamp arm 1850 is configured for use with an end effector including an ultrasonic blade (not shown) as described throughout the present disclosure. The hinge-like feature 1854 is disposed around the perimeter of the electrode 1856 to prevent delamination. The electrode 1856 is fixed to the jaw 1852 at a proximal end and is free to deflect at a distal end. Thus, throughout the present disclosure, the electrode 1856 can be referred to as a cantilevered beam electrode or a deflectable electrode.

[0233] Figure 38 is a cross-sectional view of the clamp arm 1850 shown in a loaded condition with a force Fl applied to the electrode 1856 causing the support with the hinge-like feature 1854 to collapse, in accordance with at least one aspect of the present disclosure. Figure 37 is a cross-sectional view through the clamp arm pad 1858 of the clamp arm 1850 shown in an unloaded condition. Figure 39 is a cross-sectional view of the clamp arm 1850 shown in a loaded condition with a force Fl applied to the electrode 1856 causing the support with the hinge-like feature 1854 to collapse, in accordance with at least one aspect of the present disclosure. Figure 37 is a cross-sectional view through the clamp arm pad 1858 of the clamp arm 1850 shown in an unloaded condition.

[0234] In one aspect, the present disclosure provides a support and electrode attachment member. In one aspect, the electrode is a support structure and is attached at predefined locations where stress protection is needed. In another aspect, the mechanical support can be a metal base for easy attachment to the surrounding forceps using any suitable fastening technique such as welding, laser welding, brazing, soldering, pressing, and other fastening techniques.

[0235] In one aspect, the pressure characteristics of the end effector can be varied based on the support. In one aspect, the present disclosure provides variable compression / biasing along the length of the electrode for a combined ultrasonic / bipolar RF energy device. The combined energy device includes a bipolar RF electrode that is able to deflect relative to a clamp arm that has a feature that changes the mechanical characteristics of the tissue compression under the electrode based on the amount of forceps closure or clamping. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is able to deflect under load, where the electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0236] Further background art disclosure can be found in U.S. Patent No. 6,533,784, which is incorporated by reference herein in its entirety.

[0237] In one aspect, the variable longitudinal support also acts as an interactive support. The integrated interactive support feature is configured to affect the compressibility or spring constant of the flexible support structure. The support structure can also be a plastic metal composite or overmolded part to get the integrated interactive support feature that will limit the maximum deflection of the support structure via a plastic nub extension that will interact with the underlying forceps along its length. The integrated interactive support feature can also be a spring-like feature that is able to adjust the spring constant of the electrode proportionally along its length or relative to the amount of deflection that has already been induced.

[0238] Figure 40 A clamp arm 1860 portion of an end effector is shown in accordance with at least one aspect of the present disclosure, where the clamp arm 1860 includes a clamp jaw 1862, a clamp arm pad 1864, a variable longitudinal support element 1866, a nub extension 1867, and an electrode 1868 supported by the variable longitudinal support element 1866. The clamp arm 1860 is configured for use with an end effector that includes an ultrasonic blade (not shown) as described throughout the present disclosure. The variable longitudinal support element 1866 is configured to limit the maximum deflection of the electrode 1868. The variable longitudinal support element 1866 includes a plurality of springs with variable forces (Fl, F2, F3, F4). The nub extension 1867 limits the maximum deflection of the variable longitudinal support element 1866 with variable longitudinal spring forces (Sl, S2, S3, S4), where:

[0239] S4 > S3 > S2 > S1 > F4 > F3 > F2 > F1

[0240] Figure 41A to Figure 41C FIGS. 1-3 illustrate a clamp arm 1860 under various load conditions according to at least one aspect of the present disclosure. Figure 40 FIG. 1 illustrates the clamp arm 1860 under no load or uniformly distributed load 1869. Figure 41A FIG. 2 illustrates the clamp arm 1860 under new firing conditions with no load or uniformly distributed load 1869. In Figure 41B FIG. 3 illustrates the clamp arm 1860 under high load conditions with high force 1870 at the distal end and low force 1874 at the proximal end. As shown, the distal bump extension 1867 prevents the electrode 1868 from experiencing maximum deflection. In Figure 41C FIG. 4 illustrates the clamp arm 1860 under high load with a worn bump extension 1867 with high load 1870 at the distal end, low load 1874 at the proximal end, and median load 1872 at the center. The bump extension 1867 protects the electrode 1868 from maximum deflection.

[0241] In one aspect, the present disclosure provides an end effector comprising an integrated proximal spring / distal spring. Spring mechanisms can be added to both the distal end and the proximal end of the electrode. The spring mechanisms have multiple configurations, including an integral stamped leaf spring, a separate spring, or a flexible material that acts as a spring. These springs can be configured and tuned for a desired pressure profile. The proximal loading can be reduced to extend the clamp arm pad life or increased to provide better tip performance. All of the following configurations include a metal electrode on the top of the clamp arm, a wear resistant material on the metal electrode to set the gap between the metal electrode and the ultrasonic blade, and a more flexible material on the clamp arm. The metal electrode is also connected to one pole of a bipolar RF generator in a certain way, and opposite the clamp arm is a titanium ultrasonic blade that is connected to the other pole of the bipolar RF generator. The titanium ultrasonic blade can vibrate when driven by an ultrasonic transducer.

[0242] Figure 42 is a general configuration of an end effector 1880 according to at least one aspect of the present disclosure. Figure 43 is a top view of an electrode 1886 showing an aperture 1887 for receiving a flexible material 1888 therethrough. Referring now to Figure 42 to Figure 43 . The end effector 1880 includes a clamp arm 1882, an ultrasonic blade 1884, an electrode 1886, a flexible material 1888, and a hard wear resistant material 1890. The flexible material 1888 is fixed to the clamp arm 1882 to act as a spring between the electrode 1886 and the clamp arm 1882. The hard wear resistant material 1890 is fixed to the proximal end of the electrode 1886 to set a gap between the electrode 1886 and the clamp arm 1882.

[0243] Figure 44 to Figure 45 is a first configuration of an end effector 1880 shown in FIGS. 1 1 A-1 1 C, according to at least one aspect of the present disclosure. Figure 42 to Figure 43 is a first configuration of an end effector 1880 shown in FIGS. 1 1 A-1 1 C, according to at least one aspect of the present disclosure. Figure 45 is a first configuration of an end effector 1880 shown in FIGS. 1 1 A-1 1 C, according to at least one aspect of the present disclosure.

[0244] Figure 46 to Figure 48 is a second configuration of an end effector 1880 shown in FIGS. 12A-12C, according to at least one aspect of the present disclosure. Figure 42 to Figure 43 is a second configuration of an end effector 1880 shown in FIGS. 12A-12C, according to at least one aspect of the present disclosure. Figure 47 is a second configuration of an end effector 1880 shown in FIGS. 12A-12C, according to at least one aspect of the present disclosure. Figure 48 is a second configuration of an end effector 1880 shown in FIGS. 12A-12C, according to at least one aspect of the present disclosure.

[0245] Figure 49 is a third configuration of an end effector 1880 shown in FIGS. 13A-13C, according to at least one aspect of the present disclosure. Figure 42 to Figure 43 is a third configuration of an end effector 1880 shown in FIGS. 13A-13C, according to at least one aspect of the present disclosure.

[0246] Further background art disclosure can be found in WO 2017 / 198672, which is incorporated by reference herein in its entirety.

[0247] In various aspects, the present disclosure provides an end effector for a combined ultrasonic / bipolar RF energy surgical device configured to reduce tissue gap for RF welding while minimizing shorting of the electrode to the ultrasonic blade. In one aspect, components of the end effector include a DLC or PTFE (Teflon) coating to prevent the ultrasonic blade from shorting to the electrode while achieving zero gap. In one aspect, the end effector including a non-conductive support defines a minimum gap between the electrode and the ultrasonic blade to prevent the opposing electrode and ultrasonic blade from contacting in the return path defined by the ultrasonic blade and waveguide. In one aspect, a first polymer is positioned to interact with the ultrasonic blade and create proper pressure while minimizing damage to the ultrasonic blade and a second polymer spacer is provided to avoid being damaged by the ultrasonic blade and to minimize zero gap collision with the flexible metal electrode. In another aspect, a proximal end of the flexible metal electrode has a feature that interacts with the jaw support that is designed to cause deflection of the flexible metal electrode once the jaws are closed beyond a predetermined level.

[0248] In various aspects, the present disclosure provides combined ultrasonic / bipolar RF energy surgical devices and systems. Various forms relate to user interfaces for surgical instruments having ultrasonic and / or electrosurgical (RF) end effectors configured for performing tissue treatment, dissection, cutting, and / or coagulation during surgical procedures. In one form, a user interface is provided for a combined ultrasonic and electrosurgical instrument that can be configured for open surgical procedures, but also applies to other types of surgical procedures, such as minimally invasive laparoscopic, visual or thoracoscopic procedures, for example, non-invasive endoscopic procedures in hand-held or robotically-assisted procedures. Versatility is achieved by selectively applying multiple energy modalities simultaneously, independently, sequentially, or a combination thereof. For example, versatility can be achieved by selectively using ultrasonic and electrosurgical energy (e.g., monopolar or bipolar RF energy) simultaneously, independently, sequentially, or a combination thereof.

[0249] In one aspect, the present disclosure provides a user interface for a device including an ultrasonic blade and a clamp arm having a deflectable RF electrode such that the ultrasonic blade and deflectable RF electrode cooperate to perform sealing, cutting, and clamping of tissue by cooperation of a clamping mechanism of the device including the RF electrode with the associated ultrasonic blade. The clamping mechanism includes a pivoting clamp arm that cooperates with the ultrasonic blade to grasp tissue therebetween. The clamp arm preferably has a clamping tissue pad (also referred to as a "clamp arm pad") having a plurality of axially spaced-apart clamping teeth, segments, elements, or individual units that cooperate with the ultrasonic blade of the end effector to achieve desired sealing and cutting effects on tissue while facilitating grasping and clamping of tissue during a surgical procedure.

[0250] In one aspect, the end effectors described herein include electrodes. In other aspects, the end effectors described herein include alternative forms of electrodes to provide flexible coupling of RF energy to tissue, accommodate pad wear / thinning, minimize generation of excess heat (low coefficient of friction, pressure), minimize generation of sparks, minimize interruptions due to electrical shorts, or other combinations thereof. The electrodes are fixed to the clamp at a proximal end and are free to deflect at a distal end. Thus, throughout this disclosure, the electrodes can be referred to as cantilevered beam electrodes or deflectable electrodes.

[0251] In other aspects, the end effectors described herein include a clamp arm mechanism configured to be able to apply high pressure between the pad and the ultrasonic blade to grasp and seal tissue, maximize the likelihood of the clamp arm electrodes contacting tissue in restricted or difficult scenarios, such as, for example, thin tissue, tissue under lateral tension, tissue bulge / vertical tension, especially when the bulging tissue is distanced from the clamp arm.

[0252] In other aspects, the end effectors described herein are configured to be able to balance the matching of surface area / current density between electrodes, balance and minimize heat conduction from tissue interfaces, such as, for example, affecting lesion formation and symmetry, cycle time, residual thermal energy. In other aspects, the end effectors described herein are configured to be able to minimize adhesion, tissue sticking (minimize anchoring points) and can include small polyimide pads.

[0253] In various aspects, the present disclosure provides a surgical device configured to deliver at least two energy types (e.g., ultrasonic, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue. The surgical device includes a first activation button switch for activating energy, a second button switch for selecting an energy mode for the activation button switch. The second button switch is connected to a circuit that uses at least one input parameter to define the energy mode. The input parameter can be modified remotely through a connection to a generator or through a software update.

[0254] In one aspect, at least one of the energy modes is a simultaneous mix of RF energy and ultrasonic energy, and the input parameter represents a duty cycle of the RF energy and the ultrasonic energy.

[0255] In one aspect, the second button switch can be configured to select from a predefined list of modes, and the number of modes in the list is defined by a second input parameter defined by a user.

[0256] In one aspect, the input parameter is a duty cycle, a voltage, a frequency, a pulse width, or a current.

[0257] In one aspect, the device further includes a visual indicator of the selected energy mode within a portion of the device in the surgical field.

[0258] In one aspect, the second button switch is a separate control from the end effector closure trigger.

[0259] In one aspect, the second button switch is configured to enable actuation of a second stage of the closure trigger. The first stage of the closure trigger in the closure direction is actuation of the end effector.

[0260] In one aspect, at least one of the energy modes is selected from ultrasonic, RF bipolar, RF monopolar, microwave, or IRE.

[0261] In one aspect, at least one of the energy modes is selected from ultrasonic, RF bipolar, RF monopolar, microwave, or IRE and is configured to be applied at a predefined duty cycle or pulse algorithm.

[0262] In one aspect, at least one of the energy modes is selected from sequential application of two or more of the following types of energy: ultrasonic, RF bipolar, RF monopolar, microwave, or IRE.

[0263] In one aspect, at least one of the energy modes is a simultaneous mix of two or more of the following types of energy: ultrasonic, RF bipolar, RF monopolar, microwave, and IRE.

[0264] In one aspect, at least one of the energy modes is a simultaneous mix of two or more of the following types of energy: ultrasonic, RF bipolar, RF monopolar, microwave, and IRE followed by one or more of the above.

[0265] In one aspect, at least one of the energy modes is one of the following types of energy: ultrasonic, RF bipolar, RF monopolar, microwave, and IRE followed by a simultaneous mix of two or more of the above.

[0266] In one aspect, at least one of the energy modes is a procedure or tissue specific predefined algorithm.

[0267] In one aspect, at least one of the energy modes is compiled from learned surgical behavior or activity.

[0268] In one aspect, the input parameters are at least one of the following: energy type, duty cycle, voltage, frequency, pulse width, current, impedance limit, activation time, or energy mix.

[0269] In one aspect, the second button switch is configurable to select from a predefined list of modes and the number of modes in the list is predefined or defined by a second input parameter defined by the user.

[0270] In one aspect, the energy modes described above are made available to the user by a software update to the generator.

[0271] In one aspect, the energy modes described above are made available to the user by a software update to the device.

[0272] In one aspect, the user's preferred selection is made available to multiple generators by network, cloud, or manual transfer.

[0273] In one aspect, the device further comprises a visual indicator of the selected energy mode within the device in the surgical field.

[0274] As used herein, a pushbutton switch can be a hand, 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 touching and electricity can flow between them, or "open" meaning the contacts are separated and the switch is non-conductive. The mechanism that actuates to switch between these two states (open or closed) can be of the "toggle" (flipping the switch to a continuous "on" or "off) or "momentary" (pushing for "on" and releasing for "off) type.

[0275] In one aspect, the present disclosure provides a combination 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 specialized modes that can be operated on them increases. Adding additional pushbutton switches on the device to accommodate these new additional modes would complicate the user interface and make the device more difficult to use. Therefore, the present disclosure provides techniques for designating different modes to a single physical pushbutton switch, which can have more mode selections and not increase the complexity of the housing design (e.g., not add more and more pushbutton switches). In one aspect, the housing is in the form of a handle or pistol grip.

[0276] As more specialized modes become available, there is a need to provide the surgeon using the surgical device with multiple modes without creating a complicated user interface. Surgeons want to be able to control mode selection from the sterile field, rather than relying on a circulating nurse at the generator. Surgeons want real-time feedback so they have confidence in knowing which mode to select.

[0277] Figure 50A surgical device 100 is shown in accordance with at least one aspect of the present disclosure that includes a mode selection button switch 130 on the device 100. The surgical device 100 includes a housing 102 that defines a pistol grip form of a handle 104. The housing 102 includes a trigger 106 that is received into an interior space defined by the handle 104 when squeezed. The trigger 106 is used to operate a clamp arm 111 portion of an end effector 110. The clamp jaw 112 is pivotally movable about a pivot point 114. The housing 102 is coupled to the end effector 110 by a shaft 108 that can be rotated by a knob 122.

[0278] The end effector 110 includes the clamp arm 111 and an ultrasonic blade 116. The clamp arm 111 includes the clamp jaw 112, an electrode 118, and a clamp arm pad 120. In one aspect, the clamp arm pad 120 is made of a non-stick lubricious material, such as PTFE or similar tetrafluoroethylene synthetic fluoropolymer. PTFE is a hydrophobic, non-wetting, high-density, and high-temperature resistant, multi-purpose material and has non-stick properties. The clamp arm pad 120 is non-conductive. In contrast, the electrode 118 is made of a conductive material to deliver electrical energy, such as monopolar RF, bipolar RF, microwave, or irreversible electroporation (IRE). The electrode 118 can include a gap set pad made of a polyimide material, and in one aspect, a durable high-performance polyimide-based plastic known by the trade name VESPEL and manufactured by DuPont or other suitable polyimide, polyimide polymer alloy, or PET (polyethylene terephthalate), PEEK (polyether ether ketone), PEKK (polyether ketone ketone) polymer alloy. Unless otherwise noted below, the clamp arm pads and gap pads described below are made of the materials described in this paragraph.

[0279] The electrode 118 and the ultrasonic blade 116 are coupled to a generator 133. The generator 133 is configured to be able to drive RF, microwave, or IRE energy to the electrode 118. The generator 133 is also configured to be able to drive an ultrasonic transducer acoustically coupled to the ultrasonic blade 116. In certain implementations, the electrode 118 is one pole of an electrical circuit and the ultrasonic blade 116 is the opposite pole of the electrical circuit. The housing 102 includes a switch 124 to actuate the ultrasonic blade 116. The electrical circuit can be housed in the housing 102 or can reside in the generator 133. The surgical device 100 is coupled to the generator 133 via a cable 131. The cable 131 conducts signals for the electrosurgical functions and the ultrasonic transducer.

[0280] In various aspects, the surgical device 100 is configured to be able to deliver at least two energy types (e.g., ultrasonic, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue located in the end effector 110 between the clamp arm 111 and the ultrasonic blade 116. The housing 102 of the surgical device 100 includes a first activation button switch 126 for activating energy and a second "mode" button switch 130 for selecting an energy mode for the activation button switch. The second button switch 130 is connected to a circuit that uses at least one input parameter to define the energy mode. The input parameter can be modified remotely through a connection to a generator or through a software update. The energy mode is displayed on the user interface 128.

[0281] In one aspect, the surgical instrument 100 provides mode switching through an on-device direction selector "mode" button switch 130. The user can press the mode button switch 130 to switch through different modes, and a colored light on the user interface 128 indicates the selected mode.

[0282] According to various aspects of the present disclosure, different operating modes can be assigned to the surgical device by pressing the "mode" button switch 130, where each press or push and hold of the mode button switch 130 switches the surgical device 100 between available modes displayed on the user interface 128. Once a certain mode is selected, the generator 133 will provide the appropriate generator tone, and the surgical device 100 will have a lit indicator on the user interface 128 to indicate which mode is selected.

[0283] In Figure 50 In the example shown, the "mode" selection button switch 130 is placed symmetrically on both sides of the housing 102. This enables right- and left-handed surgeons to select / switch modes without using a second hand. In this aspect, the "mode" selection button switch 130 can switch in many different directions, which enables the surgeon to select from a list of options and navigate more complex selections remotely from the sterile field without requiring a circulator to make adjustments at the generator 133. In addition to the tone of the generator 133, the lit indicator on the user interface 128 of the surgical device 100 gives the surgeon feedback on which mode is selected.

[0284] Figure 51A to Figure 51C Three options for selecting various operating modes of the surgical device 100 are shown in accordance with at least one aspect of the present disclosure. In addition to the colored light user interface 128 on the housing 102 of the surgical device 100, feedback for mode selection is audible and / or visible through the interface of the generator 133, where the generator 133 announces the selected mode in voice and / or displays a description of the selected mode on the screen of the generator 133.

[0285] Figure 51A A first mode selection option 132A is shown, in which the push button switch 130 can be pressed forward 136 or backward 134 to cycle the surgical instrument 100 between various modes.

[0286] Figure 51B A second mode selection option 132B is shown, in which the push button switch 130 is pressed up 140 or down 138 to cycle the surgical instrument 100 between various modes.

[0287] Figure 51C A third mode selection option 132C is shown, in which the push button switch 130 is pressed forward 136, backward 134, up 149, or down 138 to cycle the surgical instrument 100 between various modes.

[0288] Figure 52 A surgical device 150 according to at least one aspect of the present disclosure is shown including a mode selection push button switch 180 on the back of the device 150. The surgical device 150 includes a housing 152 defining a pistol grip form of a handle 154. The housing 152 includes a trigger 156 that is received into an interior space defined by the handle 154 when squeezed. The trigger 156 is used to operate the clamp arm 161 portion of an end effector 160. The clamp jaw 162 is pivotally movable about a pivot point 164. The housing 152 is coupled to the end effector 160 by a shaft 158 that can be rotated by a knob 172.

[0289] The end effector 160 includes a clamp arm 161 and an ultrasonic blade 166. The clamp arm 161 includes a clamp jaw 162, an electrode 168, and a clamp arm pad 170. In one aspect, the clamp arm pad 170 is made of a non-stick, lubricious material, such as PTFE or similar tetrafluoroethylene synthetic fluoropolymer. PTFE is a hydrophobic, non-wetting, high-density, and high-temperature-resistant, multi-purpose material and has non-stick properties. The clamp arm pad 170 is non-conductive. In contrast, the electrode 168 is made of a conductive material to deliver electrical energy, such as monopolar RF, bipolar RF, microwave, or irreversible electroporation (IRE). The electrode 168 can include a gap-set pad made of a polyimide material, and in one aspect, is made of a durable, high-performance polyimide-based plastic known by the trade name VESPEL and manufactured by DuPont, or other suitable polyimide, polyimide polymer alloy, or PET (polyethylene terephthalate), PEEK (polyether ether ketone), PEKK (polyether ketone ketone) polymer alloy. Unless otherwise noted below, the clamp arm pads and gap pads described below are made of the materials described in this paragraph.

[0290] The electrodes 168 and the ultrasonic blade 166 are coupled to a generator 133. The generator 133 is configured to be able to drive RF, microwave, or IRE energy to the electrodes 168. The generator 133 is also configured to be able to drive an ultrasonic transducer acoustically coupled to the ultrasonic blade 166. In certain implementations, the electrodes 168 are one pole of an electrical circuit and the ultrasonic blade 166 is the opposite pole of the electrical circuit. The housing 152 includes a switch 174 to actuate the ultrasonic blade 166. The electrical circuit can be housed in the housing 152 or can reside in the generator 133. The surgical device 150 is coupled to the generator 133 via a cable 181. The cable 181 conducts signals for the electrosurgical functions and the ultrasonic transducer.

[0291] In various aspects, the surgical device 100 is configured to be able to deliver at least two energy types (e.g., ultrasonic, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue located in the end effector 110 between the clamp arm 111 and the ultrasonic blade 116. The housing 102 of the surgical device 100 includes a first activation button switch 126 for activating energy and a second "mode" button switch 130 for selecting an energy mode for the activation button switch. The second button switch 130 is connected to an electrical circuit that uses at least one input parameter to define the energy mode. The input parameter can be modified remotely through a connection to a generator or through a software update. The energy mode is displayed on the user interface 128.

[0292] In one aspect, the surgical instrument 150 provides mode switching through an on-device forward selector "mode" button switch 180. The user can press the mode button switch 180 to switch between different modes, and a colored light on the user interface 178 indicates the selected mode.

[0293] According to various aspects of the present disclosure, different modes of operation can be assigned to the surgical device by pressing the "mode" button switch 180, where each press or push and hold of the mode button switch 180 switches the surgical device 150 between available modes displayed on the user interface 178. Once a certain mode is selected, the generator 133 will provide the appropriate generator tone, and the surgical device 150 will have a lit indicator on the user interface 178 to indicate which mode is selected.

[0294] In Figure 52In the illustrated example, the "mode" selection button switch 180 is placed on the back of the housing 150. The "mode" selection button switch 180 is positioned out of reach of the surgeon's hand holding the surgical device 150, so a second hand is required to change modes. This is intended to prevent accidental activation. To change modes, the surgeon must intentionally press the mode button switch 180 with their second hand. In addition to the tone from the generator, a lit indicator on the user interface 178 of the surgical device 150 gives the surgeon feedback as to which mode is selected.

[0295] Figure 53A A first mode selection option is shown, where as the mode button switch 180 is pressed to switch between modes, a colored light indicates the selected mode on the user interface 178.

[0296] Figure 53B A second mode selection option is shown, where as the mode button switch 180 is pressed to switch between modes, a screen 182 indicates the selected mode (e.g., LCD, e-ink).

[0297] Figure 53C A third mode selection option is shown, where as the mode button switch 180 is pressed to switch between modes, a labeled light 184 indicates the selected mode.

[0298] Figure 53D A fourth mode selection option is shown, where as the labeled button switch 186 is pressed to select a mode, it is lit to indicate the selected mode when the labeled button switch 180 is selected.

[0299] In one aspect, the present disclosure provides a combination ultrasonic / bipolar RF energy surgical device that includes energy activation by trigger closure. As more functionality is added to advanced energy surgical devices, additional button switches or controls are added to the surgical device. The additional button switches or controls make these advanced energy surgical devices complex and difficult to use. Further, when using advanced energy surgical devices to control bleeding, the difficulty of using the user interface or the ability that is difficult to obtain will spend critical time and attention during a surgical procedure.

[0300] According to the present disclosure, monopolar RF energy or advanced bipolar RF energy is activated by closing the trigger by squeezing the trigger through a first closure click to a second activation click and holding the closure until the energy delivery is stopped by the power source in the generator. Energy can also be reapplied immediately by the number of times the trigger needs to be released and re-squeezed.

[0301] Figure 54A surgical device 190 including an activation mechanism of a trigger 196 is shown in accordance with at least one aspect of the present disclosure. The surgical device 190 includes a housing 192 defining a pistol grip form of a handle 194. The housing 192 includes a trigger 196 that is received into an interior space defined by the handle 194 when squeezed. The housing 192 is coupled to an end effector by a shaft 198 that can be rotated by a knob 202. The surgical device 190 is coupled to a generator 206 via a cable 204. The cable 204 conducts signals for electrosurgical functions and an ultrasonic transducer.

[0302] The trigger 196 is configured to be able to operate the clamp arm portion of the end effector and trigger electrosurgical energy, thus eliminating the need for Figure 50 and Figure 52 the activation button switches 126, 176 shown. The trigger 196 closes to a first audible and tactile click to close the forceps for grasping tissue and further closes to a second audible and tactile click to activate electrosurgical energy such as monopolar or bipolar RF, microwave or IRE energy. The entire sequence is accomplished by activating the front button switch for cutting using ultrasonic energy.

[0303] The procedure for operating the surgical device 190: squeeze the trigger 196 to the first audible and tactile click; verify the target tissue in the forceps; activate the RF energy by squeezing the trigger 196 further to the second audible and tactile click until an end tone is heard; cut by pressing the ultrasonic front switch 200 until the tissue is divided.

[0304] The modified procedure for operating the surgical instrument 190 for additional capabilities: activate the RF energy with the trigger 196 and hold, while activating the front button switch 200 to activate the ultrasonic transducer, which will result in simultaneous application of the electrosurgical and ultrasonic energy modalities being delivered to the tissue simultaneously.

[0305] In an alternative implementation, the front button switch 200 for activating ultrasonic energy can be switched via a mode selector on the surgical device 190 or the power source generator 206 to different speeds.

[0306] For example, the surgical instruments 100, 150, 190 and associated algorithms (including Figure 1 to Figure 49 the end effectors described above in connection with Figure 50 to Figure 54 may be implemented, for example, in connection with the following generator and modular energy systems in the following surgical hub systems.

[0307] Figure 55 An alternative clamp arm including a metal clamp jaw, an electrode, a plurality of clamp arm pads, and a gap pad is shown in accordance with at least one aspect of the present disclosure. Figure 55An alternative clamp arm 2900 including a metal clamp 2904, an electrode 2906, a plurality of clamp arm pads 2920 extending through holes in the electrode 2906, a gap pad 2930, and a gap pad 2910 is shown in accordance with at least one aspect of the present disclosure. The electrode 2906 is attached to the metal clamp 2906 at a weld location 2908. The electrode 2906 wraps around the metal clamp 2904 and the electrode 2906 is deflectable. The gap pad 2910 has a top PI layer 2912 and a bottom elastomer layer 2914 attached directly to the metal clamp 2904 for pressure control. The clamp arm pads 2920 are attached directly to the metal clamp 2904 and are composite pads having a high pressure center zone 2922 made of PTFE for heat reduction and an outer zone 2924 made of PI for electrode 2906 deflection.

[0308] In one aspect, the combination ultrasound / bipolar RF energy surgical device is configured to be operable within a surgical hub system. Figure 56 is a surgical system 3102 including a surgical hub 3106 paired with a visualization system 3108, a robotic system 3110, and a smart instrument 3112 in accordance with at least one aspect of the present disclosure. Referring now to Figure 56 , the hub 3106 is depicted in communication with the visualization system 3108, the robotic system 3110, and a handheld smart surgical instrument 3112 constructed in a similar fashion as the surgical instruments 100, 150, 190 described above. Figure 50 to Figure 55 The hub 3106 includes a hub display 3135, an imaging module 3138, a generator module 3140, a communication module 3130, a processor module 3132, and a storage array 3134. In certain aspects, as shown in Figure 56 , the hub 3106 also includes a smoke evacuation module 3126 and / or a suction / irrigation module 3128.

[0309] During a surgical procedure, energy application to tissue for sealing and / or cutting is often associated with smoke evacuation, suction of excess fluids, and / or irrigation of the tissue. Fluid lines, power lines, and / or data lines from different sources are often tangled during a surgical procedure. Addressing this issue during a surgical procedure can lose valuable time. Disconnecting the lines can require disconnecting the lines from their respective modules, which can require resetting the modules. The hub modular housing 3136 provides a unified environment for managing power lines, data lines, and fluid lines, which reduces the frequency of tangling between such lines.

[0310] Aspects of the present disclosure provide a surgical hub for use in a surgical procedure involving the application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combined generator module that is slidably receivable in a docking bay of the hub housing. The docking bay 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 that are seated in a single unit. In one aspect, the combined generator module further includes a smoke evacuation component for connecting the combined generator module to at least one energy delivery cable of a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid, and / or particulate generated by the application of therapeutic energy to tissue, and a fluid line extending from the remote surgical site to the smoke evacuation component.

[0311] In one aspect, the fluid line is a first fluid line, and a second fluid line extends from the remote surgical site to an aspiration and irrigation module slidably received in the hub housing. In one aspect, the hub housing includes a fluid interface.

[0312] Certain surgical procedures can require the application of more than one energy type to tissue. One energy type can be more advantageous for cutting tissue, while a different energy type can 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 the sealed tissue. Aspects of the present disclosure provide a solution in which the hub modular housing 136 is configured to accommodate different generators and facilitate interactive communication between them. One of the advantages of the hub modular housing 136 is to enable quick removal and / or replacement of the various modules.

[0313] Aspects of the present disclosure provide a modular surgical housing for use in a surgical procedure involving the application of energy to tissue. The modular surgical housing includes a first energy generator module configured to generate a first energy for application to tissue, and a first docking bay including a first docking port including first data and power contacts, wherein the first energy generator module is slidably movable into electrical engagement with the power and data contacts, and wherein the first energy generator module is slidably movable out of electrical engagement with the first power and data contacts,

[0314] Further to the above, the modular surgical housing further comprises 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 comprising a second docking port comprising second data and power contacts, wherein the second energy generator module is slidably movable into electrical engagement with the power and data contacts, and wherein the second energy generator is slidably movable out of electrical contact with the second power and data contacts.

[0315] Further, the modular surgical housing further comprises a communication bus between the first docking port and the second docking port configured to facilitate communication between the first energy generator module and the second energy generator module.

[0316] In one aspect, the present disclosure provides a generator configured to drive a combined ultrasonic / bipolar RF energy surgical device. Figure 57 An example of a generator 3900 according to at least one aspect of the present disclosure is shown. As Figure 57 shown, the generator 3900 is a form of generator configured to be coupled to a surgical instrument 100, 150, 190 as Figure 50 to Figure 55 described, and is further configured to drive the surgical instrument 100, 150, 190 in a manner including as Figure 56Adaptive ultrasonic and electrosurgical control algorithms are executed in the surgical data network of the illustrated modular communication hub. The generator 3900 is configured to deliver multiple energy modalities to surgical instruments. The generator 3900 provides RF and ultrasonic signals for delivery to surgical instruments, either independently or simultaneously. The RF and ultrasonic signals can be provided separately or in combination, and can be provided simultaneously. As described above, at least one generator output can deliver multiple energy modalities (e.g., ultrasonic, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, among others) through a single port, and these signals can be delivered separately or simultaneously to an end effector to treat tissue. The generator 3900 includes a processor 3902 coupled to a waveform generator 3904. The processor 3902 and the waveform generator 3904 are configured to generate multiple signal waveforms based on information stored in a memory coupled to the processor 3902, which is not shown for clarity of the present disclosure. Digital information associated with a waveform is provided to the waveform generator 3904, which includes one or more DAC circuits to convert the digital input into an analog output. The analog output is fed to an amplifier 3906 for signal conditioning and amplification. The conditioned and amplified output of the amplifier 3906 is coupled to a power transformer 3908. The signal is coupled through the power transformer 3908 to the secondary side in the patient isolation side. A first signal of a first energy modality is provided to a surgical instrument between the terminals labeled ENERGY1 and RETURN. A second signal of a second energy modality is coupled across a capacitor 3910 and is provided to the surgical instrument between the terminals labeled ENERGY2 and RETURN. It will be appreciated that more than two energy modalities can be output, and thus the subscript“n” can be used to designate that up to n ENERGYn terminals can be provided, where n is a positive integer greater than one. It will also be appreciated that up to“n” return paths RETURNn can be provided without departing from the scope of the present disclosure.

[0317] The first voltage sense circuit 3912 is coupled across the terminals labeled ENERGY1 and RETURN path to measure the output voltage therebetween. The second voltage sense circuit 3924 is coupled across the terminals labeled ENERGY2 and RETURN path to measure the output voltage therebetween. As shown, the current sense circuit 3914 is disposed in series with the RETURN leg of the secondary side of the power transformer 3908 to measure the output current for either energy modality. If different return paths are provided for each energy modality, a separate current sense circuit should be provided in each return leg. The outputs of the first and second voltage sense circuits 3912, 3924 are provided to respective isolation transformers 3916, 3922, and the output of the current sense circuit 3914 is provided to another isolation transformer 3918. The outputs of the isolation transformers 3916, 3928, 3922 on the primary side (non-patient isolated side) of the power transformer 3908 are provided to one or more ADC circuits 3926. The digitized outputs of the ADC circuits 3926 are provided to the processor 3902 for further processing and computation. The output voltage and current feedback information can be employed to regulate the output voltage and current provided to the surgical instrument, and to compute output impedance and other parameters. Input / output communication between the processor 3902 and the patient isolated circuitry is provided through the interface circuit 3920. Sensors can also be in electrical communication with the processor 3902 through the interface circuit 3920.

[0318] In one aspect, the impedance can be determined by the processor 3902 by dividing the output of the first voltage sense circuit 3912 coupled across the terminals labeled ENERGY1 / RETURN or the second voltage sense circuit 3924 coupled across the terminals labeled ENERGY2 / RETURN by the output of the current sense circuit 3914 disposed in series with the RETURN leg of the secondary side of the power transformer 3908. The outputs of the first and second voltage sense circuits 3912, 3924 are provided to separate isolation transformers 3916, 3922, and the output of the current sense circuit 3914 is provided to another isolation transformer 3916. The digitized voltage and current sense measurements from the ADC circuits 3926 are provided to the processor 3902 for computation of impedance. For example, the first energy modality ENERGY1 can be ultrasonic energy, and the second energy modality ENERGY2 can be RF energy. However, other energy modalities include irreversible and / or reversible electroporation and / or microwave energy, among others, in addition to ultrasonic and bipolar or monopolar RF energy modalities. Also, while the power transformer 3908 is shown as a single transformer, separate transformers can be provided for each energy modality. Figure 57The illustrated example shows that a single return path RETURN can be provided for two or more energy modalities, but in other aspects, multiple return paths RETURNn can be provided for each energy modality ENERGYn. Thus, as described herein, the ultrasonic transducer impedance can be measured by dividing the output of the first voltage sensing circuit 3912 by the output of the current sensing circuit 3914, and the tissue impedance can be measured by dividing the output of the second voltage sensing circuit 3924 by the output of the current sensing circuit 3914.

[0319] As shown in Figure 57 The generator 3900, which includes at least one output port, can include a power transformer 3908 having a single output and multiple taps to provide power to the end effector in the form of one or more energy modalities, such as ultrasonic, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, etc., for example, depending on the type of tissue treatment being performed. For example, the generator 3900 can deliver energy at a higher voltage and lower current to drive an ultrasonic transducer, at a lower voltage and higher current to drive an RF electrode for sealing tissue, or at a coagulation waveform for spot coagulation using a monopolar or bipolar RF electrosurgical electrode. The output waveforms from the generator 3900 can be manipulated, switched, or filtered to provide the frequency to the end effector of the surgical instrument. The connection of the ultrasonic transducer to the output of the generator 3900 would preferably be between the outputs labeled ENERGY1 and RETURN, as shown in Figure 56 In one example, the connection of the RF bipolar electrodes to the output of the generator 3900 would preferably be between the outputs labeled ENERGY2 and RETURN. In the case of a monopolar output, the preferred connections would be the active electrode (e.g., pencil or other probe) of the ENERGY2 output and a suitable return pad connected to the RETURN output.

[0320] Additional details are disclosed in U.S. Patent Application Publication No. 2017 / 0086914, entitled “TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS,” published March 30, 2017, which is incorporated by reference herein in its entirety.

[0321] In one aspect, the present disclosure provides a modular energy system configured to be able to drive a combined ultrasonic / bipolar RF energy surgical device. Figure 58 is a diagram of a variety of modules and other components that can be combined to customize a modular energy system in accordance with at least one aspect of the present disclosure.Figure 59A is a first example modular energy system configuration according to at least one aspect of the present disclosure, including a head module and a display screen presenting a graphical user interface (GUI) for relaying information about modules connected to the head module. Figure 59B is a modular energy system mounted to a cart according to at least one aspect of the present disclosure. Figure 59A is a modular energy system mounted to a cart according to at least one aspect of the present disclosure.

[0322] Reference is now made to Figure 57 to Figure 59B Due to the number of devices required to perform a surgical procedure, ORs in every part of the world are a tangled web of cords, devices, and people. Surgical capital equipment tends to be a major contributor to this problem, as most surgical capital equipment performs a single specialized task. Due to its specialized nature, and because a surgeon needs to use multiple different types of devices during the course of a single surgical procedure, an OR can be forced to keep two or even more surgical capital devices (such as energy generators) on standby. Each of these surgical capital devices must be plugged into a power source separately, and can be connected to one or more other devices that pass between OR personnel, creating a tangle of cords that must be navigated. Another problem faced in modern ORs is that each of these specialized surgical capital devices has its own user interface, and must be controlled independently of other equipment within the OR. This creates complexity in properly controlling multiple different devices connected to one another, and forces users to accept training and to remember different types of user interfaces (which can change based on the task or surgical procedure being performed, in addition to changing between each capital device). This cumbersome, complex process can require more personnel to be stationed within the OR, and can create hazards if multiple devices cannot be properly controlled in tandem with one another. Therefore, consolidating surgical capital equipment technology into a single system that can flexibly meet the needs of surgeons to reduce the footprint of surgical capital equipment within the OR would simplify the user experience, reduce the chaos in the OR, and prevent the difficulties and hazards associated with controlling multiple capital devices at once. Furthermore, making such a system scalable or customizable would allow new technologies to be incorporated into the existing surgical system with ease, without requiring the entire surgical system to be replaced, and without requiring OR personnel to learn new user interfaces or device controls for each new technology.

[0323] A surgical hub can be configured to interchangeably receive a variety of modules, which in turn can interact with surgical devices (e.g., surgical instruments or smoke evacuators) or provide various other functionality (e.g., communication). In one aspect, a surgical hub can be embodied as a combination of a surgical console and a surgical hub as described in connection with Figure 58 to Figure 59BA modular energy system 4000 is shown. The modular energy system 4000 can include a variety of different modules 4001 that can be connected together in a stacked configuration. In one aspect, the modules 4001 can be physically and communicably coupled together when stacked or otherwise connected together to form a single assembly. Further, the modules 4001 can be interchangeably connected together in different combinations or arrangements. In one aspect, each of the modules 4001 can include a uniform or universal array of connectors disposed along its upper and lower surfaces, allowing any module 4001 to be connected to another module 4001 in any arrangement (except that, in some aspects, certain module types, such as a header module 4002, can be configured to be usable as, for example, the uppermost module within a stack). In one alternative aspect, the modular energy system 4000 can include a housing configured to receive and hold the modules 4001, as shown. The modular energy system 4000 can also include a variety of different components or accessories that are also connectable to or otherwise associated with the modules 4001. In another aspect, the modular energy system 4000 can be embodied as the generator module 3140, 3900 of the surgical hub 3106 Figure 56 ). In yet another aspect, the modular energy system 4000 can be a system that is distinct from the surgical hub 3106. In such aspects, the modular energy system 4000 can be communicably coupled to the surgical hub 3106 for the transmission and / or receipt of data therebetween. Figure 56 to Figure 57

[0324] The modular energy system 4000 can be assembled from a variety of different modules 4001, some examples of which are shown in FIGS. 40A-40C. In one aspect, the modules 4001 can be physically and communicably coupled together when stacked or otherwise connected together to form a single assembly. Further, the modules 4001 can be interchangeably connected together in different combinations or arrangements. In one aspect, each of the modules 4001 can include a uniform or universal array of connectors disposed along its upper and lower surfaces, allowing any module 4001 to be connected to another module 4001 in any arrangement (except that, in some aspects, certain module types, such as a header module 4002, can be configured to be usable as, for example, the uppermost module within a stack). In one alternative aspect, the modular energy system 4000 can include a housing configured to receive and hold the modules 4001, as shown. The modular energy system 4000 can also include a variety of different components or accessories that are also connectable to or otherwise associated with the modules 4001. In another aspect, the modular energy system 4000 can be embodied as the generator module 3140, 3900 of the surgical hub 3106 Figure 58 ​As 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 screen 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 head module 4002. Energy module 4004 (which may also be referred to as generator modules 3140, 3900) Figure 56 to Figure 57 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 57 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.

[0325] The modular energy system 4000 can also include a variety of accessories 4029 that can be connected to the modules 4001 for controlling their functions, or otherwise configured to work in conjunction with the modular energy system 4000. The accessories 4029 can include, for example, a single-pedal footswitch 4032, a dual-pedal footswitch 4034, and a cart 4030 for supporting the modular energy system 4000 thereon. The footswitches 4032, 4034 can be configured to control, for example, activation or functions of a particular energy modality output by the energy module 4004.

[0326] By utilizing modular components, the depicted modular energy system 4000 provides a surgical platform that is optimized as technology becomes available and can be customized to the needs of the facility and / or surgeon. Further, the modular energy system 4000 supports combined devices (e.g., dual electrosurgical and ultrasonic energy generators) and supports software driven algorithms for customizing tissue effects. Further, the surgical system architecture reduces capital footprint by combining multiple technologies essential to surgical procedures into a single system.

[0327] The various modular components that can be used in conjunction with the modular energy system 4000 can include a monopolar energy generator, a bipolar energy generator, a dual electrosurgical / ultrasonic energy generator, a display screen, as well as various other modules and / or other components, some of which are also described above in connection with the modular energy system 1000. Figures 1-55

[0328] Referring now to Figure 59A ​In some aspects, the head module 4002 can include a display screen 4006 that presents a GUI 4008 for relaying information about the modules 4001 connected to the head module 4002. In some aspects, the GUI 4008 of the display screen 4006 can provide a consolidated control point for all of the modules 4001 that make up a particular configuration of the modular energy system 4000. In alternative aspects, the head module 4002 can not contain a display screen 4006, or the display screen 4006 can be detachably connected to the housing 4010 of the head module 4002. In such aspects, the head module 4002 can be communicably couplable to an external system configured to display information generated by the modules 4001 of the modular energy system 4000. For example, in a robotic surgical application, the modular energy system 4000 can be communicably couplable to a robotic cart or a robotic console configured to display information generated by the modular energy system 4000 to an operator of the robotic surgical system. As another example, the modular energy system 4000 can be communicably couplable to a mobile display that can be carried or affixed to a surgical staff for their viewing. In yet another example, the modular energy system 4000 can be communicably couplable to the surgical hub 4100 or another computer system that can include a display 4104. In aspects that utilize a user interface that is separate from or otherwise distinct from the modular energy system 4000, the user interface can be wirelessly connected to the modular energy system 4000 as a whole or one or more modules 4001 thereof, such that the user interface can display information from the connected modules 4001 thereon.

[0329] Still referring to Figure 59A The energy module 4004 can include a port assembly 4012 that includes a plurality of different ports configured to deliver different energy modalities to corresponding surgical instruments that can be connected thereto. In the illustrated aspect, the port assembly 4012 includes a bipolar port 4014, a first monopolar port 4016a, a second monopolar port 4018b, a neutral electrode port 4018 to which a monopolar return pad can be connected, and a combination energy port 4020. However, this particular combination of ports is merely illustrative, and alternative combinations of ports and / or energy modalities are possible for the port assembly 4012. Figures 58-59B

[0330] As described above, the modular energy system 4000 can be assembled into different configurations. Moreover, different configurations of the modular energy system 4000 can also be used for different surgical procedure types and / or different tasks. For example, Figure 59A and Figure 59B ​A first exemplary configuration of the modular energy system 4000 is shown, which includes a head module 4002 (including a display screen 4006) and an energy module 4004 connected together. Such a configuration can be suitable for, e.g., laparoscopic and open surgical procedures.

[0331] Figures 60-64 An exemplary surgical system 10 having ultrasonic features and electrosurgical features including any of the end effectors, surgical instruments, and generators described herein is shown. Figure 60 A surgical system 10 including a generator 12 and a surgical instrument 14 is shown. The surgical instrument 14 is operatively coupled with the generator 12 via a power cable 16. The generator 12 is operable to provide power to the surgical instrument 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 be able to provide power to the surgical instrument 14 to simultaneously or independently deliver ultrasonic energy and electrosurgical bipolar RF energy.

[0332] The surgical instrument 14 of the present example includes a handle assembly 18, a shaft assembly 20 extending distally from the handle assembly 18, and an end effector 22 disposed at a distal end of the shaft assembly 20. The handle assembly 18 includes a main body 24 including a pistol grip 26 and energy control buttons 28, 30 configured to be manipulated by a surgeon. A trigger 32 is coupled to a lower portion of the main body 24 and is pivotable toward and away from the pistol grip 26 to selectively actuate the end effector 22, as described in greater detail below. In other suitable variations of the surgical instrument 14, the handle assembly 18 can include, e.g., a scissors grip configuration. An ultrasonic transducer 34 is housed inside and supported by the main body 24. In other configurations, the ultrasonic transducer 34 can be disposed outside of the main body 24.

[0333] As shown in FIGS. 1 and 2, the end effector 22 includes an ultrasonic blade 36 and a clamp arm 38 configured to be selectively pivoted toward and away from the ultrasonic blade 36 for clamping tissue therebetween. The ultrasonic blade 36 is acoustically coupled with the ultrasonic transducer 34, which is configured to drive (i.e., vibrate) the ultrasonic blade 36 at an ultrasonic frequency for cutting and / or sealing tissue positioned in contact with the ultrasonic blade 36. The clamp arm 38 is operatively coupled with the trigger 32 such that the clamp arm 38 is configured to pivot toward the ultrasonic blade 36 to a closed position in response to pivoting of the trigger 32 toward the pistol grip 26. Additionally, the clamp arm 38 is configured to pivot away from the ultrasonic blade 36 to an open position in response to pivoting of the trigger 32 away from the pistol grip 26 (see, e.g., FIG. 2). Figure 61 and Figure 62 As shown, the end effector 22 includes an ultrasonic blade 36 and a clamp arm 38 configured to be selectively pivoted toward and away from the ultrasonic blade 36 for clamping tissue therebetween. The ultrasonic blade 36 is acoustically coupled with the ultrasonic transducer 34, which is configured to drive (i.e., vibrate) the ultrasonic blade 36 at an ultrasonic frequency for cutting and / or sealing tissue positioned in contact with the ultrasonic blade 36. The clamp arm 38 is operatively coupled with the trigger 32 such that the clamp arm 38 is configured to pivot toward the ultrasonic blade 36 to a closed position in response to pivoting of the trigger 32 toward the pistol grip 26. Additionally, the clamp arm 38 is configured to pivot away from the ultrasonic blade 36 to an open position in response to pivoting of the trigger 32 away from the pistol grip 26 (see, e.g., FIG. 2). Figures 60-62Given 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.

[0334] 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.

[0335] like Figures 60-64 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 61-64 As best viewed, 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 therebetween and pivotally coupled to the distal end 54 of the inner tube 48, 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.

[0336] In the present example, the inner tube 48 is longitudinally fixed relative to the handle assembly 18, and the outer tube 46 is configured to be translatable relative to the inner tube 48 and the handle assembly 18 along the longitudinal axis of the shaft assembly 20. As the outer tube 46 is translated distally, the clamp arm 38 is pivoted about the pivot pin 56 toward its open position. As the outer tube 46 is translated proximally, the clamp arm 38 is pivoted in the opposite direction toward its closed position. The proximal end of the outer tube 46 is operatively coupled with the trigger 32, e.g., via a linkage assembly, such that actuation of the trigger 32 causes the outer tube 46 to translate relative to the inner tube 48, thereby causing the clamp arm 38 to open or close. In other suitable configurations not shown herein, the outer tube 46 can be longitudinally fixed, and the inner tube 48 can be configured to be translatable for moving the clamp arm 38 between its open and closed positions.

[0337] The shaft assembly 20 and the end effector 22 are configured to be rotatable together about the longitudinal axis relative to the handle assembly 18. Figure 63 The illustrated retention pin 66 extends transversely through the proximal portions of the outer tube 46, the inner tube 48, and the waveguide 50, thereby rotationally coupling these components relative to one another. In the present example, a knob 68 is provided at the proximal end portion of the shaft assembly 20 to facilitate rotation of the shaft assembly 20 and the end effector 22 relative to the handle assembly 18. The knob 68 is rotationally fixed to the shaft assembly 20 with the retention pin 66, which extends through a proximal collar of the knob 68. It will be appreciated that in other suitable configurations, the knob 68 can be omitted or replaced by an alternative rotational actuation structure.

[0338] The ultrasonic waveguide 50 is acoustically coupled at its proximal end to the ultrasonic transducer 34, e.g., by a threaded connection, and at its distal end to the ultrasonic blade 36, as Figure 64The ultrasonic blade 36 is shown as being integrally formed with the waveguide 50 such that the blade 36 extends directly distally from the distal end of the waveguide 50. As such, the waveguide 50 acoustically couples the ultrasonic transducer 34 with the ultrasonic blade 36 and functions to transmit ultrasonic mechanical vibrations from the transducer 34 to the blade 36. Thus, the ultrasonic transducer 34, waveguide 50, and ultrasonic blade 36 together define an acoustic assembly. During use, the ultrasonic blade 36 can be positioned in direct contact with tissue, with or without the assistance of clamping force provided by the clamp arm 38, to impart ultrasonic vibrational energy to the tissue and thereby cut and / or seal the tissue. For example, the blade 36 can cut through tissue clamped between the clamp arm 38 and a first treatment side of the blade 36, or the blade 36 can cut through tissue positioned in contact with an oppositely disposed second treatment side of the blade 36, e.g., during a "back-cut" movement. In some variations, the waveguide 50 can amplify the ultrasonic vibrations delivered to the blade 36. Additionally, the waveguide 50 can include various features operable to control the gain of the vibrations, and / or features adapted to tune the waveguide 50 to a selected resonant frequency. Additional features of the ultrasonic blade 36 and waveguide 50 are described in greater detail below.

[0339] The waveguide 50 is supported within the inner tube 48 by a plurality of node support elements 70 positioned along the length of the waveguide 50, as shown. Figures 63-64 Specifically, the node support elements 70 are positioned longitudinally along the waveguide 50 at locations corresponding to acoustic nodes defined by the resonant ultrasonic vibrations transmitted through the waveguide 50. The node support elements 70 can provide structural support to the waveguide 50 and acoustic isolation between the waveguide 50 and the inner tube 48 and outer tube 46 of the shaft assembly 20. In variations, the node support elements 70 can comprise O-rings. The waveguide 50 is supported at its distal-most acoustic node by a node support element in the form of an overmolded member 72, as shown. Figure 64 The waveguide 50 is longitudinally and rotationally fixed within the shaft assembly 20 by a retaining pin 66 that passes through a transverse through-hole 74 formed at a proximally disposed acoustic node of the waveguide 50, such as, for example, the proximal-most acoustic node.

[0340] In the present example, the distal tip 76 of the ultrasonic blade 36 is located at a position corresponding to an anti-node associated with the resonant ultrasonic vibrations transmitted through the waveguide 50. Such a configuration enables the acoustic assembly of the instrument 14 to be tuned to a preferred resonant frequency f o When the ultrasonic transducer 34 is energized by the generator 12 to impart mechanical vibrations through the waveguide 50 to the blade 36, the distal tip 76 of the blade 36 is caused to longitudinally oscillate, for example, in a range of about 20 microns to 120 microns peak-to-peak, and in some cases, for example, at a predetermined vibration frequency f oLongitudinally oscillate in the range of about 20 microns to 50 microns. When the ultrasonic blade 36 is positioned in contact with tissue, the ultrasonic oscillations of the blade 36 can simultaneously sever the tissue and denature the proteins in adjacent tissue cells, providing a coagulation effect with minimal thermal diffusion.

[0341] Examples

[0342] Embodiments of various aspects of end effectors and surgical instruments of the present disclosure are provided below. One aspect of an end effector or surgical instrument can include any one or more of the following embodiments and any combination thereof:

[0343] Embodiment 1. An end effector, comprising: a clamp arm; and an ultrasonic blade configured to acoustically couple to an ultrasonic transducer and electrically couple to one pole of a generator; wherein the clamp arm comprises: a clamp jaw; a plurality of variable longitudinal support elements; and a cantilevered electrode configured to electrically couple to an opposite pole of the generator, wherein the cantilevered electrode is fixed to the clamp jaw at a proximal end and is free to deflect at a distal end, wherein the cantilevered electrode is supported by the variable longitudinal support elements, and wherein the variable longitudinal support elements exert a variable force on the cantilevered electrode from the proximal end to the distal end.

[0344] Embodiment 2. The end effector of Embodiment 1, wherein the variable longitudinal support elements limit a maximum deflection of the cantilevered electrode.

[0345] Embodiment 3. The end effector of any one of Embodiments 1-2, wherein the variable longitudinal support elements comprise a plurality of springs having a variable force (F).

[0346] Embodiment 4. The end effector of Embodiment 3, wherein the cantilevered electrode further comprises a tab extension on the cantilevered electrode between the cantilevered electrode and the clamp jaw.

[0347] Embodiment 5. The end effector of Embodiment 4, wherein the tab extension on the cantilevered electrode between the cantilevered electrode and the clamp jaw limits a maximum deflection of the variable longitudinal support elements with a variable longitudinal spring force (S).

[0348] Embodiment 6. The end effector of Embodiment 5, wherein the variable longitudinal spring force (S) is less than the variable force (F).

[0349] Embodiment 7. The end effector of any one of Embodiments 1-6, wherein the clamp arm further comprises a clamp arm pad.

[0350] Example 8. An end effector comprising: a clamp arm; and an ultrasonic blade configured to acoustically couple to an ultrasonic transducer and electrically couple to one pole of a generator; wherein the clamp arm comprises: a clamp jaw; a cantilevered electrode configured to electrically couple to an opposite pole of the generator; and a flexible material secured to the clamp jaw to support the cantilevered electrode and act as a spring between the cantilevered electrode and the clamp jaw.

[0351] Example 9. The end effector of Example 8, wherein the clamp arm further comprises a hard, wear-resistant material secured to the cantilevered electrode to set a gap between the cantilevered electrode and the ultrasonic blade.

[0352] Example 10. The end effector of Example 9, wherein the cantilevered electrode comprises a hard, wear-resistant material secured to a proximal end of the cantilevered electrode and a hard, wear-resistant material secured to a distal end of the cantilevered electrode.

[0353] Example 11. The end effector of any of Examples 8-10, wherein the cantilevered electrode defines an aperture for receiving the flexible material therethrough.

[0354] Example 12. An end effector comprising: a clamp arm; and an ultrasonic blade configured to acoustically couple to an ultrasonic transducer and electrically couple to one pole of a generator; wherein the clamp arm comprises: a clamp jaw; a cantilevered electrode configured to electrically couple to an opposite pole of the generator; and a leaf spring element disposed at a distal end of the cantilevered electrode.

[0355] Example 13. The end effector of Example 12, wherein a proximal end of the cantilevered electrode is fixedly attached to the clamp jaw.

[0356] Example 14. The end effector of any of Examples 12-13, further comprising a hard, wear-resistant pad disposed on a proximal end of the cantilevered electrode to set a gap between the cantilevered electrode and the clamp arm.

[0357] Example 15. The end effector of any of Examples 12-14, wherein the leaf spring defines a symmetrical element on a lateral side of the distal end of the cantilevered electrode.

[0358] Example 16. An end effector comprising: a clamp arm; and an ultrasonic blade; wherein the clamp arm comprises: a clamp jaw; a cantilevered electrode; and a compressible material attached to a distal end of the cantilevered electrode.

[0359] Example 17. The end effector of Example 16, wherein the compressible material attached to the distal end of the cantilevered electrode is disposed between the cantilevered electrode and the clamp jaw.

[0360] Example 18. The end effector of Example 16, wherein the distal end of the clamp jaw defines a pocket for receiving the compressible material.

[0361] Example 19. A surgical instrument comprising: a housing; an ultrasonic transducer; and an end effector comprising: a clamp arm; and an ultrasonic blade acoustically coupled to the ultrasonic transducer and electrically coupled to one pole of a generator; wherein the clamp arm comprises: a clamp jaw; a plurality of variable longitudinal support elements; and a cantilever electrode electrically coupled to an opposite pole of the generator, wherein the cantilever electrode is fixed to the clamp jaw at a proximal end and is free to deflect at a distal end, and wherein the cantilever electrode is supported by the variable longitudinal support elements; wherein the variable longitudinal support elements exert a variable force on the cantilever electrode from the proximal end to the distal end.

[0362] Example 20. The surgical instrument of Example 19, wherein the variable longitudinal support elements limit a maximum deflection of the cantilever electrode.

[0363] Example 21. The surgical instrument of any one of Examples 19-20, wherein the variable longitudinal support elements comprise a plurality of springs having a variable force (F).

[0364] Example 22. The surgical instrument of Example 21, wherein the cantilever electrode further comprises a tab extension on the cantilever electrode between the cantilever electrode and the clamp jaw.

[0365] Example 23. The surgical instrument of Example 22, wherein the tab extension on the cantilever electrode between the cantilever electrode and the clamp jaw limits a maximum deflection of the variable longitudinal support elements with a variable longitudinal spring force (S).

[0366] Example 24. The surgical instrument of Example 22, wherein the variable longitudinal spring force (S) is less than the variable force (F).

[0367] Example 25. The surgical instrument of any one of Examples 19-24, wherein the clamp arm further comprises a clamp arm pad.

[0368] Example 26. A surgical instrument comprising: a housing; an ultrasonic transducer; and an end effector comprising: a clamp arm; and an ultrasonic blade acoustically coupled to the ultrasonic transducer and electrically coupled to one pole of a generator; wherein the clamp arm comprises: a clamp jaw; a cantilever electrode electrically coupled to an opposite pole of the generator.

[0369] Example 27. The surgical instrument of Example 26, further comprising a flexible material fixed to the clamp jaw to support the cantilever electrode and act as a spring between the cantilever electrode and the clamp jaw.

[0370] Example 28. The surgical instrument of Example 27, wherein the clamping arm further comprises a hard, wear-resistant material fixed to the cantilevered electrode to set a gap between the cantilevered electrode and the ultrasonic blade.

[0371] Example 29. The surgical instrument of Example 28, wherein the cantilevered electrode comprises a hard, wear-resistant material fixed to a proximal end of the cantilevered electrode and a hard, wear-resistant material fixed to a distal end of the cantilevered electrode.

[0372] Example 30. The surgical instrument of any one of Examples 27-29, wherein the cantilevered electrode defines an aperture for receiving a flexible material therethrough.

[0373] Example 31. The surgical instrument of any one of Examples 26-30, further comprising a leaf spring element disposed at a distal end of the cantilevered electrode.

[0374] Example 32. The surgical instrument of Example 31, wherein a proximal end of the cantilevered electrode is fixedly attached to the clamp.

[0375] Example 33. The surgical instrument of any one of Examples 31-32, further comprising a hard, wear-resistant pad disposed on a proximal end of the cantilevered electrode to set a gap between the cantilevered electrode and the clamping arm.

[0376] Example 34. The surgical instrument of any one of Examples 31-33, wherein the leaf spring defines a symmetrical element on a lateral side of the distal end of the cantilevered electrode.

[0377] Example 35. The surgical instrument of any one of Examples 26-34, further comprising a compressible material attached to a distal end of the cantilevered electrode.

[0378] Example 36. The surgical instrument of Example 35, wherein the compressible material attached to the distal end of the cantilevered electrode is disposed between the cantilevered electrode and the clamp.

[0379] Example 37. The surgical instrument of Example 36, wherein a distal end of the clamp defines a dimple for receiving the compressible material.

[0380] Although a number of forms have been exemplified and described, the scope of the appended claims is not intended to be limited to the particular forms disclosed. Many modifications, variations, changes, substitutions, combinations, and equivalents will occur to those skilled in the art upon reading this disclosure and may be made without departing from the scope of the disclosure. Additionally, alternative forms will occur to practitioners of the art. For instance, the structural description of each element associated with the forms described can alternatively be described as a means for providing the function performed by the element. Furthermore, where materials are disclosed for certain components, other materials may, be used. Therefore, the above description and the appended claims should not be construed as limiting, but rather as exemplifying. The description and the claims are intended to cover all such modifications, combinations, and variations as come within the scope of the forms disclosed. The appended claims are intended to cover all such modifications, variations, changes, substitutions, modifications, and equivalents.

[0381] The detailed description set forth above exemplifies various forms of apparatus and / or methods. As such, the foregoing detailed description is to be regarded as merely illustrative rather than restrictive. The scope of the disclosure is to be limited solely by the appended claims. The foregoing detailed description and appended claims are to be interpreted in the broadest manner consistent with the principles of patent law. For example, the specification and the appended claims can be read to include any apparatus and / or method capable of accomplishing the functions described herein. Additionally, the components of the forms disclosed herein may

[0382] Instructions used to program logic to perform various disclosed aspects can be stored within a memory in the system, such as dynamic random access memory (DRAM), cache, flash memory, or other storage. Furthermore, instructions can be distributed via a network or by way of other computer readable media. Thus, a machine-readable medium can include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), but is not limited to, soft disks, optical disks, magnetic disks, Read Only Memory (ROM), Random Access Memory (RAM), erasable programmable read only memory (EPROM), electrically erasable programmable read only memory (EEPROM), flash memory, or any other suitable memory device. Furthermore, a machine-readable medium includes any medium that can be used to provide instructions to a processor or other processing unit, and includes both volatile and non-volatile media, removable and non-removable media, and includes media that is implemented in a client server relationship with additional circuits or turn. Accordingly, a non-transitory computer readable medium includes any type of tangible, machine- readable medium, including storage and transmission for programming instructions or data, states relating to a machine-readable medium that furnishes (i.e., supplies, provides) programming instructions, data, or both, to be used by or in connection with the instruction execution system, apparatus, or device, e.g., a general purpose computer, special purpose computer, or a microprocessor. The described machine-readable medium does not include a modulated data signal or carrier wave. The described features can also be implemented as a machine-readable medium comprising a non-transitory machine-readable medium (e.g., optical, semiconductor, or other implementation) encoded with the instructions that, when executed, cause a machine to perform methods as described herein.

[0383] As used herein in any aspect, the term "control circuitry" can refer to, be part of, or include, for example, hardwired circuitry, programmable circuitry (for example, a computer processor including one or more individual instruction processing cores, processing units, processors, microcontrollers, microcontroller units, controllers, digital signal processors (DSPs), programmable logic devices (PLD), programmable logic arrays (PLA), field programmable gate arrays (FPGA)), state machine circuitry, firmware that stores instructions executed by programmable circuitry, and any combination thereof. Control circuitry can be collectively, or individually, implemented as circuitry that forms a part of a larger system, for example, an integrated circuit (IC), an application-specific integrated circuit (ASIC), a system on a chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smart phone, and the like. As such, "control circuitry," as used herein, includes, but is not limited to, electronic circuitry having a plurality of discrete electronic components, electronic circuitry having a plurality of integrated circuits, electronic circuitry having a plurality of application-specific integrated circuits, electronic circuitry forming a general-purpose computing device configured by a computer program (for example, a general-purpose computer configured by computer program instructions to perform the methods and / or devices described herein, or a microprocessor configured by computer program instructions to perform the methods and / or devices described herein), electronic circuitry forming a memory device (for example, forming a random access memory), and / or electronic circuitry forming a communications device (for example, a modem, a communications switch, or an optical-electrical device). Those skilled in the art will recognize that the subject matter described herein can be implemented in an analog or digital form, or some combination thereof.

[0384] As used in any aspect herein, the term “logic” can refer to an application program, software, firmware, and / or circuitry configured to perform any of the aforementioned operations. Software can be embodied as a software package, code, instructions, instruction sets, and / or data recorded in one or more non-transitory computer-readable storage media. Firmware can be embodied as code, instructions, or instruction sets and / or data that are hard-coded (e.g., nonvolatile) in memory devices.

[0385] As used in any aspect herein, the terms “component,” “system,” “module” and the like can refer to a computer-related entity, either hardware, a combination of hardware and software, software, or software in execution.

[0386] As used in any aspect herein, “algorithm” refers to a self-consistent sequence of steps leading to a desired result, where a “step” refers to a manipulation of physical quantities and / or logic states, which may, but need not, take the form of electrical or magnetic signals, that may, but need not, be stored, transferred, combined, compared, and otherwise manipulated in a manner that is consistent with the nature of the physical quantities and / or logic states. Commonly used in referring to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms can be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities.

[0387] The network can include a packet-switched network. The communication devices can be capable of communicating with each other using a selected packet-switched network communication protocol. One example communication protocol can include an Ethernet communication protocol that can be capable of allowing communication using the Transmission Control Protocol / Internet Protocol (TCP / IP). The Ethernet protocol can conform to or be compatible with the Ethernet standard entitled “IEEE 802.3 Standard” published by the Institute of Electrical and Electronics Engineers (IEEE) in December 2008 and / or a later version of this standard. Alternatively or additionally, the communication devices can be capable of communicating with each other using an X.25 communication protocol. The X.25 communication protocol can conform to or be compatible with a standard published by the International Telecommunication Union Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, the communication devices can be capable of communicating with each other using a Frame Relay communication protocol. The Frame Relay communication protocol can conform to or be compatible with a standard published by the Consultative Committee International Telegraph and Telephone (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers can be capable of communicating with each other using an Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol can conform to or be compatible with an ATM standard entitled “ATM-MPLS Network Interworking 2.0” published by the ATM Forum in August 2001 and / or a later version of this standard. Of course, different and / or later developed connection-oriented network communication protocols are likewise contemplated herein.

[0388] Unless specifically stated otherwise as apparent from the above disclosure, it is appreciated that, throughout the foregoing disclosure, the use of terms such as "processing," "computing," "calculating," "determining," "displaying," or the like, can refer to the action and processes of a computer system, or similar electronic

[0389] One or more components can be referred to herein as "configured to," "configurable to," "operable / operative to," "adapted to / adaptable to," "capable of," "adapted to adaptably," etc. Those skilled in the art will recognize that "configured to" can generally include active- state components and / or inactive-state components and / or pending-state components unless context clearly dictates otherwise.

[0390] The terms "proximal" and "distal" are used herein with respect to a clinician manipulating a handle portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician, and the term "distal" refers to the portion positioned away from the clinician. It will also be appreciated that, for conciseness and clarity, spatial terms such as "vertical," "horizontal," "up," and "down," can be used herein with respect to the accompanying drawings. However, surgical instruments are employed in many orientations and positions, and the terms are not intended to be limiting and / or absolute.

[0391] Those skilled in the art will recognize that, in general, the terms used herein, and particularly in the appended claims (e.g., in the text of the appended claims) are intended to be "open" terms (e.g., the terms "including" and "including but not limited to", the terms "has" and "having" are intended to be interpreted as "including at least", the term "including" should be interpreted as "including without limitation", etc.). Those skilled in the art will also recognize that, where specific numbers can be mentioned in the claim language, these are intended to be "open" unless context clearly dictates otherwise, and there is no intention to limit the scope of the claims to the specific numbers recited unless context clearly indicates otherwise. For example, to aid understanding, the following appended claims can contain the use of the introductory phrases "at least one" and "one or more" to introduce claim language. However, the use of such phrases should not be taken to imply that the use of indefinite articles such as "a" or "an" to introduce claim language will limit any particular claim to contain only one such recitation, even when the same claim includes the introductory phrase "one or more" or "at least one" and the indefinite article such as "a" or "an" (e.g., "a" and / or "an" should generally be interpreted to mean "at least one" or "one or more"); this also applies to the use of the definite article "the" to introduce claim language.

[0392] 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".

[0393] 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.

[0394] 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.

[0395] Any patent application, patent, non-patent publication, or other disclosure material referred to in this specification, in any application data sheet, or in any correspondence, filed herewith, is hereby incorporated by reference, to the extent not inconsistent herewith, for all purposes. Accordingly, and to the extent necessary, the disclosure herein supersedes any contradictory or contradictory materials in any such incorporated-by-reference material. Any material, or portion thereof, that is said to be incorporated by reference herein, but which contradicts the present definition, statement, or other disclosure material set forth herein, is only incorporated to the extent that it is consistent with the present definition, statement, or other disclosure material.

[0396] In general, numerous benefits have been described which result from the techniques described herein. The foregoing detailed description has set forth various embodiments of the application via specific illustrative examples. These embodiments are indicative, however, of but a few of the various ways in which the principles of the application can be employed. Other objects, advantages, and novel features of the application will become apparent from the following detailed description when read in conjunction with the accompanying drawings. The detailed description is directed to certain specific embodiments of the application, but the application itself is not intended to be limited to these particular embodiments. The scope of the application should be determined by the appended claims and their equivalents, in which all patentable variations within the scope of the claims are reserved.

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; Multiple variable longitudinal support elements; and A cantilever electrode configured to be electrically connected to the opposite pole of the generator, wherein the cantilever electrode is fixed to the clamp at a proximal end and freely deflected at a distal end, wherein the cantilever electrode is supported by the variable longitudinal support element, and wherein the variable longitudinal support element applies a variable force on the cantilever electrode from the proximal end to the distal end.

2. The end effector according to claim 1, wherein, The variable longitudinal support element limits the maximum deflection of the cantilever electrode.

3. The end effector according to claim 1, wherein, The variable longitudinal support element includes multiple springs that apply different forces (F).

4. The end effector according to claim 3, wherein, The cantilever electrode also includes a protrusion extension on the cantilever electrode located between the cantilever electrode and the clamp.

5. The end effector according to claim 4, wherein, The protrusion extension on the cantilever electrode, located between the cantilever electrode and the clamp, limits the maximum deflection of the variable longitudinal support element with a variable longitudinal spring force (S).

6. The end effector according to claim 5, wherein, The variable longitudinal spring force (S) is greater than the force (F).

7. The end effector according to claim 1, wherein, The clamping arm also includes a clamping arm pad.

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