Clamp arm jaw for minimizing tissue attachment and improving tissue control

Abstract

Disclosed are an end effector and a surgical instrument including the end effector. 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 an electrical generator. The clamp arm includes a clamp jaw and a cantilever electrode configured to electrically couple to the opposite pole of the electrical generator. The cantilever electrode is fixed to the clamp jaw at a proximal end and is free to deflect at a distal end. The clamp arm includes a control function for adjusting a tissue path relative to the clamp arm to create a predetermined contact location.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims priority to U.S. Provisional Patent Application No. 62 / 955,292, filed Dec. 30, 2019, entitled "COMBINATION ENERGY MODALITY END - EFFECTOR", the entire disclosure of which is incorporated herein by reference under 35 U.S.C. § 119(e).

[0002] (Field of the Invention) The present disclosure generally relates to an end - effector adapted and configured to operate with multiple energy modalities and capable of sealing and cutting tissue by applying the multiple energy modalities simultaneously, independently, or sequentially. More specifically, the present disclosure relates to an end - effector adapted and configured to operate with a surgical instrument that uses a combined ultrasonic and electrosurgical system, such as, for example, monopolar or bipolar radio - frequency (RF), and is capable of sealing and cutting tissue by applying ultrasonic and electrosurgical energy modalities simultaneously, independently, or sequentially. The energy modalities can be applied based on tissue parameters or other algorithms. The end - effector can be adapted and configured to couple to a hand - held surgical system or a robotic surgical system.

Background Art

[0003] Ultrasonic surgical instruments using ultrasonic energy modalities are finding an increasingly wide range of applications in surgery due to the special performance characteristics of such instruments. Depending on the particular instrument configuration and operating parameters, ultrasonic surgical instruments can effect tissue cutting and hemostasis by coagulation substantially simultaneously and, desirably, minimize patient trauma. The cutting act is typically effected at the distal end of the instrument by an end effector, ultrasonic blade, or tip of an ultrasonic blade that transmits ultrasonic energy to tissue in contact with the end effector. An ultrasonic end effector can comprise, among other components, an ultrasonic blade, clamp arms, and pads.

[0004] Some surgical instruments utilize ultrasonic energy for both purposes of precise cutting and coagulation control. Ultrasonic energy cuts and coagulates by vibrating a blade in contact with tissue. The ultrasonic blade vibrates at a high frequency (e.g., 55,500 times per second), denaturing proteins in the tissue to form an adhesive clot. The pressure exerted by the blade surface on the tissue causes blood vessels to collapse, enabling the clot to form a hemostatic seal. The accuracy of cutting and coagulation is controlled by the surgeon's technique and adjustment of power level, blade edge, tissue traction, and blade pressure.

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

[0006] The electrical energy applied by an electrosurgical instrument can be transmitted to the instrument by a generator in communication with the handpiece. The electrical energy may be in the form of radiofrequency (RF) energy. RF energy is a form of electrical energy that can be in a frequency range of 200 kilohertz (kHz) to 1 megahertz (MHz). During application, the electrosurgical instrument can transmit low-frequency RF energy through tissue, which causes ion agitation or friction, i.e., resistive heating, thereby raising the temperature of the tissue. Since a distinct boundary is created between the tissue affected by the procedure and the surrounding tissue, the surgeon can operate with a high level of accuracy and control without sacrificing adjacent non-target tissue. The low operating temperature of RF energy is useful for removing, shrinking, or tunneling through soft tissue while simultaneously sealing blood vessels. Connective tissue is mainly composed of collagen and contracts when in contact with heat, so RF energy acts particularly well on connective tissue.

[0007] 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 typically be limited to less than 5 MHz. However, in bipolar RF energy applications, the frequency can be almost any frequency. Frequencies above 200 kHz can typically be used for monopolar applications to avoid unnecessary stimulation of nerves and muscles resulting from the use of low-frequency currents. If risk analysis indicates that the potential for neuromuscular stimulation has been mitigated to an acceptable level, lower frequencies can be used for bipolar applications. Frequencies above 5 MHz are not normally used to minimize problems associated with high-frequency leakage current. However, higher frequencies can be used in the case of bipolar applications. Generally, 10 mA is recognized as the lower threshold for the thermal effect on tissue.

[0008] The ultrasonic surgical instruments and electrosurgical instruments of the nature described in this specification can be configured for open surgery, minimally invasive surgery, or non-invasive surgery. Minimally invasive surgery involves the use of cameras and instruments inserted through small incisions to visualize and treat conditions within joints or body cavities. Minimally invasive procedures can be performed entirely within the body or, depending on the situation, used in conjunction with smaller access incisions. These combined approaches are known, for example, as "arthroscopic, laparoscopic, or thoracoscopic assisted surgery." The surgical instruments described in this specification can also be used in non-invasive procedures such as endoscopic surgery, for example. The instruments can be controlled by a surgeon using a handheld instrument or a robot.

SUMMARY OF THE INVENTION

PROBLEMS TO BE SOLVED BY THE INVENTION

[0009] The problem with using these surgical instruments is that, depending on the type of tissue being treated, single or multiple energy modalities cannot be controlled and customized. 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 combinations thereof. The energy modality composite end effector described herein overcomes the above deficiencies and improves the quality of tissue treatment, sealing, or cutting, or combinations thereof.

MEANS FOR SOLVING THE PROBLEMS

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

[0011] 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 the energy and a second button for selecting the energy mode of the activation button. The second button is connected to a circuit that defines the energy mode using at least one input parameter. The input parameter can be remotely modified via connection to the generator or software update.

[0012] In one aspect, the present disclosure provides an ultrasonic / bipolar RF energy composite surgical device. The ultrasonic / bipolar RF energy composite 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 shape conforming 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, the at least one electrode functions as a support that is deflectable relative to the opposing ultrasonic blade. The at least one electrode is configured to extend across the ultrasonic blade and be deflectable relative to the clamp arm, and has a function for varying the mechanical properties of tissue compression under the at least one electrode. The at least one electrode includes a feature for preventing unintentional contact between the electrode and the ultrasonic blade.

[0013] In another aspect, the present disclosure provides an ultrasonic / bipolar RF energy composite surgical device. The ultrasonic / bipolar RF energy composite 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 shape conforming 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, the movable clamp jaw includes at least one non-biased and deflectable electrode for minimizing contact between the ultrasonic blade and the RF electrode. The ultrasonic blade pad includes a function for fixing the electrode to the pad. As the height of the pad wears or is cut, the height of the electrode relative to the clamp jaw is gradually adjusted. Once the clamp jaw moves away from the ultrasonic blade, the electrode remains in its new position.

[0014] In another aspect, the present disclosure provides an ultrasonic / bipolar RF energy composite surgical device. The ultrasonic / bipolar RF energy composite surgical device comprises an end effector. The end effector comprises a clamp arm and an ultrasonic blade. The clamp arm comprises a movable clamp jaw, a shape conforming polymer pad, and at least one bipolar RF electrode. 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, at least one bipolar RF electrode is deflectable and is biased more distally than proximally. The bipolar RF electrode is deflectable relative to the clamp jaw. The end effector is configured to vary the mechanical properties of a tissue compression portion proximal to the distal end to create a more uniform or different pattern of pressure compared to the pressure pattern with clamping alone.

[0015] In another aspect, the present disclosure provides an ultrasonic / bipolar RF energy composite surgical device. The ultrasonic / bipolar RF energy composite surgical device comprises an end effector. The end effector comprises a clamp arm and an ultrasonic blade. The clamp arm comprises a movable clamp jaw, a shape conforming polymer pad, and at least one bipolar RF electrode. 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, the pad is such that 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 the tissue compression under the electrode based on the closure or clamping amount of the clamp jaw.

[0016] In another aspect, the present disclosure provides an ultrasonic / bipolar RF energy composite surgical device. The ultrasonic / bipolar RF energy composite surgical device includes an end effector. The end effector includes a clamping arm and an ultrasonic blade. The clamping arm includes a movable clamp jaw, a shape conforming polymer pad, and at least one bipolar RF electrode. 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, the pad includes an asymmetric segment for providing support to the ultrasonic blade support, and the electrode is movable. The asymmetric segmented pad is configured to cooperatively engage with the movable bipolar RF electrode. The segmented ultrasonic support pad extends at least partially through the bipolar RF electrode. At least one pad element is significantly higher than a second pad element. The first pad element extends completely through the bipolar RF electrode, and the second pad element extends partially through the bipolar RF electrode. The first pad element and the second pad element are made of dissimilar materials.

[0017] In another aspect, the present disclosure provides an ultrasonic / bipolar RF energy composite surgical device. The ultrasonic / bipolar RF energy composite surgical device includes an end effector. The end effector includes a clamping arm and an ultrasonic blade. The clamping arm includes a movable clamp jaw, a shape conforming polymer pad, and at least one bipolar RF electrode. 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, variations in the physical parameters of the electrode in combination with a deflectable electrode are used to vary the energy density delivered to the tissue and the tissue interaction. The physical surface of the electrode varies along its length and, as the electrode also deflects, varies the contact area of the electrode with the tissue and / or the energy density from the electrode to the tissue.

[0018] In another aspect, the present disclosure provides an ultrasonic / bipolar RF energy composite surgical device. The ultrasonic / bipolar RF energy composite 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 shape conforming polymer pad, and at least one bipolar RF electrode. 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 that reduces the power delivered by the ultrasonic generator or the RF generator when a short circuit in the contact between the ultrasonic blade and the electrode is detected, to prevent damage to the ultrasonic blade. The ultrasonic blade control algorithm monitors for an electrical short circuit or contact of the ultrasonic blade with the electrode. This detection is used to adjust the power / amplitude level of the ultrasonic transducer when a minimum electrical threshold is exceeded, to adjust the threshold of the transducer power / amplitude to a level lower than the minimum threshold that would cause damage to the ultrasonic blade, the ultrasonic generator, the bipolar RF electrode, or the bipolar RF generator. The electrical parameter being monitored can be the impedance (Z) or electrical continuity of the tissue. 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 any of the electrical parameter, pressure, or time or any combination of these parameters.

[0019] In another aspect, the present disclosure provides an ultrasonic / bipolar RF energy composite surgical device. The ultrasonic / bipolar RF energy composite 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 shape conforming polymer pad, and at least one bipolar RF electrode. 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, a clamp jaw feature or surface is provided on the clamp arm to minimize tissue adhesion and improve tissue controllability. The tissue path or clamp region of the clamp arm includes a feature configured to adjust the tissue path relative to the clamp arm / ultrasonic blade to create a predetermined contact position to reduce tissue adhesion and charring.

[0020] In another aspect, the present disclosure provides an ultrasonic / bipolar RF energy combined surgical device. The ultrasonic / bipolar RF energy combined 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 shape conforming polymer pad, and at least one bipolar RF electrode. 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, a partially conductive clamp arm pad is provided to allow the electrode to completely wear out and minimize an electrical short circuit between the ultrasonic blade and the bipolar RF electrode. The clamp arm pad includes a conductive portion and a non-conductive portion, whereby the clamp arm pad can function as one of the bipolar RF electrodes while also functioning as a wearable support structure for the ultrasonic blade. The conductive portion of the clamp arm pad is located around the perimeter of the pad and not directly under the ultrasonic blade contact area. The conductive portion is configured to break down or wear away without causing any contact with the ultrasonic blade to interrupt the conductivity of the remaining portion of the conductive pad.

[0021] In addition to the foregoing, various other methods, and / or systems, and / or aspects of program products are described and explained in the teachings of the present disclosure, such as in the text of the "claims" and / or detailed description and / or drawings.

[0022] The foregoing is a general overview and, as such, may contain simplifications, generalizations, inclusions, and / or omissions of detail. Accordingly, those skilled in the art will appreciate that this "Summary of the Invention" is merely exemplary and is not intended to be limiting in any way. Other aspects, features, and advantages of the devices and / or processes, and / or other subject matter described herein will become apparent from the teachings set forth herein.

[0023] In one or more various aspects, the associated system includes, without limitation, circuitry and / or programming for operating in accordance with aspects of the methods referenced herein. That circuitry and / or programming can be, in essence, any combination of hardware, software, and / or firmware configured to affect aspects of the methods referenced herein, depending essentially on the design choices of the system designer. In addition to the foregoing, various other method and / or system aspects are described and illustrated in the teachings of the present disclosure, such as in the specification (e.g., the claims and / or detailed description) and / or the drawings.

[0024] Furthermore, it should be understood that any one or more of the forms, embodiments, and examples described below can be combined with any one or more of the other forms, embodiments, and examples described below.

[0025] The above "Summary of the Invention" is merely exemplary and is not intended to be limiting in any way. In addition to the exemplary aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description.

Brief Description of the Drawings

[0026] The novel features of the described forms are particularly pointed out in the appended claims. However, the described forms can be best understood with reference to the following description, taken in conjunction with the accompanying drawings, in terms of both their construction and the manner of operation.

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【Figure 6 Shows a second assembly step according to at least one aspect of the present disclosure. Shows the tissue pad unit in the unlocked position. ​ Shows a second assembly step according to at least one aspect of the present disclosure. Shows the tissue pad unit in the locked position. ​ Shows a third assembly step in which a single-piece elastic / superelastic block is coupled to a clamp jaw according to at least one aspect of the present disclosure. ​Shows a fourth assembly process according to at least one aspect of the present disclosure. The first sub-assembly manufactured in the second assembly process described in FIGS. 63-65 is assembled with the second sub-assembly manufactured in the third assembly process as described in the process of FIG. 66, indicating that a clamp arm is being manufactured. ​ Shows a fourth assembly process according to at least one aspect of the present disclosure. Shows the pad tip substantially aligned with the clamp arm slot. ​ Shows a fourth assembly process according to at least one aspect of the present disclosure. Shows an electrode coupled to the clamp arm at the junction. ​ Shows a fourth assembly process according to at least one aspect of the present disclosure. Shows a clamp arm functional portion that prevents the tissue pad unit from exiting in the direction indicated by the arrow. ​ Shows a fourth assembly process according to at least one aspect of the present disclosure. It is a detailed view of an electrode coupled to the clamp arm at the junction. ​ Shows a fourth assembly process according to at least one aspect of the present disclosure. It is a detailed view of an electrode coupled to the clamp arm at the junction. ​ Shows a fifth assembly process according to at least one aspect of the present disclosure. Shows press-fitting an assembly of two small wear-resistant gap pads into the slot defined by the electrodes and sliding a large wear-resistant gap pad into the slot defined by the electrodes. ​ Shows a fifth assembly process according to at least one aspect of the present disclosure. It is an end view of the clamp arm. ​ Shows a clamp arm including a filling material filled between the electrode and the clamp jaw according to at least one aspect of the present disclosure. ​Shown are various devices for addressing these desired improvements, according to at least one aspect of the present disclosure. A clamp arm is shown that facilitates manufacturing by eliminating a separate clamp arm electrode, constructing the surface of the clamp arm, and eliminating a separate electrode blade. ​ Shown are various devices for addressing these desired improvements, according to at least one aspect of the present disclosure. A clamp arm is shown that prevents tissue accumulation between the electrode and the clamp jaw by adding a skirt around the electrode or alternatively around the clamp jaw. ​ Shown is a cross-sectional view of an end effector comprising an ultrasonic blade and a clamp arm configured to improve tissue grasping distally, according to at least one aspect of the present disclosure. ​ Shown is a clamp arm comprising a clamp jaw, an electrode, a clamp arm pad having a plurality of teeth, a curtain located on each side of the electrode to minimize the tissue clamping point, and a blunt nose / clamp arm bumper to minimize electrode detachment by first contacting the tissue while incising with a dull blade. ​ Shown is an alternative clamp arm comprising a clamp jaw, an electrode, a clamp arm pad including a plurality of teeth, and curtains located on both sides of the clamp arm pad. It is an exploded view of the clamp arm. ​ Shown is an alternative clamp arm comprising a clamp jaw, an electrode, a clamp arm pad including a plurality of teeth, and curtains located on both sides of the clamp arm pad. It is a cross-sectional view of the clamp arm. ​ Shown is a side view of a clamp arm, according to at least one aspect of the present disclosure. ​A side view of a clamp arm having a cantilever electrode in a deflected state for withdrawing tissue from teeth of a clamp arm pad, according to at least one aspect of the present disclosure. ​ A bottom perspective view of a clamp arm, according to at least one aspect of the present disclosure. ​ A bottom perspective view of a clamp arm having a cantilever electrode in a deflected state for withdrawing tissue from teeth of a clamp arm pad, according to at least one aspect of the present disclosure. ​ A device is shown that includes a mode selection button switch on a surgical device, according to at least one aspect of the present disclosure. ​ Three options for selecting various operating modes of a surgical device are shown, according to at least one aspect of the present disclosure. A first mode selection option is shown where the button switch is pressed forward and backward to sequentially switch the surgical instrument through various modes. ​ Three options for selecting various operating modes of a surgical device are shown, according to at least one aspect of the present disclosure. A second mode selection option is shown where the button switch is pressed up and down to sequentially switch the surgical instrument through various modes. ​ Three options for selecting various operating modes of a surgical device are shown, according to at least one aspect of the present disclosure. A third mode selection option is shown where the button switch is pressed forward, backward, up, and down to sequentially switch the surgical instrument through various modes. ​ A device is shown that includes a mode selection button switch on the back of a surgical device, according to at least one aspect of the present disclosure. ​ The first mode selection option is shown, where colored light indicates the selected mode on the user interface when the mode button switch is pressed to sequentially switch through various modes. ​It shows the second mode selection option. When the mode button switch is pressed and sequentially switched to various modes, the screen (for example, a liquid crystal display, e-ink) shows the selected mode. ​ It shows the third mode selection option. When the mode button switch is pressed and sequentially switched to various modes, the encoded light shows the selected mode. ​ It shows the fourth mode selection option. When the encoded button switch is selected and the mode in which the encoded button switch is pressed is selected, the encoded button switch emits light so as to show the selected mode. ​ It shows a surgical device with a trigger activation mechanism according to at least one aspect of the present disclosure. ​ It shows an alternative clamp arm including a metal clamp jaw, an electrode, a plurality of clamp arm pads, and a gap pad according to at least one aspect of the present disclosure. ​ It is a surgical system including a visualization system, a robotic system, and a surgical hub paired with an intelligent instrument according to at least one aspect of the present disclosure. ​ It shows an example of a generator according to at least one aspect of the present disclosure. ​ It is a diagram of various modules and other components that can be combined to customize a modular energy system according to at least one aspect of the present disclosure. ​ It is a configuration of a first exemplary modular energy system including a header module and a display screen representing a graphical user interface (GUI) for relaying information about a module connected to the header module. ​A modular energy system mounted on a cart, as shown in FIG. 95A, according to at least one aspect of the present disclosure. ​ A perspective view of an example of a surgical system having a generator and a surgical instrument operable to treat tissue using ultrasonic energy and bipolar RF energy, according to at least one aspect of the present disclosure. ​ A perspective top view of an end effector of a surgical instrument of FIG. 96, according to 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. ​ A perspective bottom view of the end effector of FIG. 97, according to at least one aspect of the present disclosure. ​ A partially exploded perspective view of the surgical instrument of FIG. 96, according to at least one aspect of the present disclosure. ​ An enlarged exploded perspective view of a distal portion of a shaft assembly and an end effector of the surgical instrument of FIG. 96, according to at least one aspect of the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION

[0027] The applicant of the present application owns the following US provisional patent applications filed on December 30, 2019, the entire disclosure of each of which is incorporated herein by reference: · US Provisional Patent Application No. 62 / 955,294, titled "USER INTERFACE FOR SURGICAL INSTRUMENT WITH COMBINATION ENERGY MODALITY END-EFFECTOR", · US Provisional Patent Application No. 62 / 955,299, titled "ELECTROSURGICAL INSTRUMENTS FOR COMBINATION ENERGY DELIVERY", and · US Provisional Patent Application No. 62 / 955,306, titled "SURGICAL INSTRUMENTS".

[0028] The applicant of the present application owns the following U.S. patent applications filed on the same day as the present application, each of which is hereby incorporated by reference in its entirety: · Attorney Docket No. END9232USNP1 / 190715-1, Title of Invention "USER INTERFACE FOR SURGICAL INSTRUMENT WITH COMBINATION ENERGY MODALITY END-EFFECTOR", · Attorney Docket No. END9233USNP1 / 190716-1M, Title of Invention "METHOD OF OPERATING A COMBINATION ULTRASONIC / BIPOLAR RF SURGICAL DEVICE WITH A COMBINATION ENERGY MODALITY END-EFFECTOR", · Attorney Docket No. END9233USNP2 / 190716-2, Title of Invention "DEFLECTABLE SUPPORT OF RF ENERGY ELECTRODE WITH RESPECT TO OPPOSING ULTRASONIC BLADE", · Attorney Docket No. END9233USNP3 / 190716-3, Title of Invention "NON-BIASED DEFLECTABLE ELECTRODE TO MINIMIZE CONTACT BETWEEN ULTRASONIC BLADE AND ELECTRODE", · Attorney Docket No. END9233USNP4 / 190716-4, Title of Invention "DEFLECTABLE ELECTRODE WITH HIGHER DISTAL BIAS RELATIVE TO PROXIMAL BIAS", · Attorney Docket No. END9233USNP5 / 190716-5, Title of Invention "DEFLECTABLE ELECTRODE WITH VARIABLE COMPRESSION BIAS ALONG THE LENGTH OF THE DEFLECTABLE ELECTRODE", · Attorney Docket No. END9233USNP6 / 190716-6, Invention Title "ASYMMETRIC SEGMENTED ULTRASONIC SUPPORT PAD FOR COOPERATIVE ENGAGEMENT WITH A MOVABLE RF ELECTRODE", · Attorney Docket No. END9233USNP7 / 190716-7, Invention Title "VARIATION IN ELECTRODE PARAMETERS AND DEFLECTABLE ELECTRODE TO MODIFY ENERGY DENSITY AND TISSUE INTERACTION", · Attorney Docket No. END9233USNP8 / 190716-8, Invention Title "TECHNIQUES FOR DETECTING ULTRASONIC BLADE TO ELECTRODE CONTACT AND REDUCING POWER TO ULTRASONIC BLADE", and · Attorney Docket No. END9233USNP10 / 190716-10, Invention Title "PARTIALLY CONDUCTIVE CLAMP ARM PAD TO ENABLE ELECTRODE WEAR THROUGH AND MINIMIZE SHORT CIRCUITING".

[0029] The applicant of this application owns the following U.S. patent applications filed on May 28, 2020, each of which is hereby incorporated by reference in its entirety: · U.S. Patent Application No. 16 / 885,813, Invention Title "METHOD FOR AN ELECTROSURGICAL PROCEDURE", · U.S. Patent Application No. 16 / 885,820, Invention Title "ARTICULATABLE SURGICAL INSTRUMENT", · U.S. Patent Application No. 16 / 885,823, Invention Title "SURGICAL INSTRUMENT WITH JAW ALIGNMENT FEATURES", · U.S. Patent Application No. 16 / 885,826, titled "SURGICAL INSTRUMENT WITH ROTATABLE AND ARTICULATABLE SURGICAL END EFFECTOR", · U.S. Patent Application No. 16 / 885,838, titled "ELECTROSURGICAL INSTRUMENT WITH ASYNCHRONOUS ENERGIZING ELECTRODES", · U.S. Patent Application No. 16 / 885,851, titled "ELECTROSURGICAL INSTRUMENT WITH ELECTRODES BIASING SUPPORT", · U.S. Patent Application No. 16 / 885,860, titled "ELECTROSURGICAL INSTRUMENT WITH FLEXIBLE WIRING ASSEMBLIES", · U.S. Patent Application No. 16 / 885,866, titled "ELECTROSURGICAL INSTRUMENT WITH VARIABLE CONTROL MECHANISMS", · U.S. Patent Application No. 16 / 885,870, titled "ELECTROSURGICAL SYSTEMS WITH INTEGRATED AND EXTERNAL POWER SOURCES", · U.S. Patent Application No. 16 / 885,873, titled "ELECTROSURGICAL INSTRUMENTS WITH ELECTRODES HAVING ENERGY FOCUSING FEATURES", · U.S. Patent Application No. 16 / 885,879, titled "ELECTROSURGICAL INSTRUMENTS WITH ELECTRODES HAVING VARIABLE ENERGY DENSITIES", · U.S. Patent Application No. 16 / 885,881, titled "ELECTROSURGICAL INSTRUMENT WITH MONOPOLAR AND BIPOLAR ENERGY CAPABILITIES", · U.S. Patent Application No. 16 / 885,888, titled "ELECTROSURGICAL END EFFECTORS WITH THERMALLY INSULATIVE AND THERMALLY CONDUCTIVE PORTIONS", · U.S. Patent Application No. 16 / 885,893, titled "ELECTROSURGICAL INSTRUMENT WITH ELECTRODES OPERABLE IN BIPOLAR AND MONOPOLAR MODES", · U.S. Patent Application No. 16 / 885,900, titled "ELECTROSURGICAL INSTRUMENT FOR DELIVERING BLENDED ENERGY MODALITIES TO TISSUE", · U.S. Patent Application No. 16 / 885,917, titled "CONTROL PROGRAM ADAPTATION BASED ON DEVICE STATUS AND USER INPUT", · U.S. Patent Application No. 16 / 885,923, titled "CONTROL PROGRAM FOR MODULAR COMBINATION ENERGY DEVICE", and · U.S. Patent Application No. 16 / 885,931, titled "SURGICAL SYSTEM COMMUNICATION PATHWAYS".

[0030] Before describing in detail various forms of the surgical instrument, it should be noted that the exemplary forms are not limited to the details of the structure and arrangement of the components illustrated in the accompanying drawings and description in terms of their application or use. The exemplary forms may be implemented or incorporated in other forms, variations, and modifications, and may be practiced or carried out in various ways. Further, unless otherwise indicated, the terms and expressions used herein are selected for the purpose of describing the exemplary forms for the convenience of the reader and are not intended to limit them.

[0031] Furthermore, it should be understood that any one or more of the forms, embodiments, and examples described below can be combined with any one or more of the other forms, embodiments, and examples described below.

[0032] The various forms are directed to improved ultrasonic and / or electrosurgical (RF) instruments configured to effect the treatment, incision, dissection, and / or coagulation of tissue during surgery. In one form, a combined ultrasonic and electrosurgical instrument can be configured for use in open surgery, but also has applications in other types of surgery, such as minimally invasive laparoscopy, arthroscopic surgery, or thoracoscopic surgery, in either a handheld or robot-assisted surgery, and in non-invasive endoscopy, for example. Versatility is achieved by selectively applying multiple energy modalities simultaneously, independently, sequentially, or in combinations thereof. For example, versatility can be achieved by selectively using ultrasonic and electrosurgical energy (e.g., monopolar or bipolar RF energy) in any of a simultaneous, independent, sequential, or combined manner.

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

[0034] In one aspect, the end effector described herein comprises an electrode. In other aspects, the end effector described herein comprises an alternative to the above electrode. Thereby, it provides RF energy coupling to the tissue that conforms to the shape of the tissue, adapts to wear / thinning of the pad, minimizes the generation of excessive heat (low coefficient of friction, pressure), minimizes the generation of sparks, minimizes interruptions due to electrical short circuits, or minimizes combinations thereof. The electrode is fixed at its proximal end to the clamp jaw and is free to deflect at its distal end. Thus, throughout the present disclosure, the electrode may be referred to as a cantilever beam electrode or a deflectable electrode.

[0035] In other aspects, the end effector described herein applies a high pressure between the pad and the ultrasonic blade to grip and seal tissue, for example, in restricted or difficult scenarios such as thin tissue, tissue under lateral tension, tissue under lifting / vertical tension, especially tissue that is lifted away from the clamp arm, so as to maximize the probability that the clamp arm electrode contacts the tissue. It comprises a clamp arm mechanism configured as such.

[0036] In other aspects, the end effector described herein is configured to balance the surface area / current density between the electrodes and minimize while balancing the heat conduction from the interface with the tissue, for example, affecting the formation and symmetry of the denatured part, and also affecting cycle time, residual heat energy, etc.

[0037] In other aspects, the end effector described herein is configured to minimize adhesion, tissue attachment (minimize anchor points) and may include small polyimide pads.

[0038] In various aspects, the present disclosure provides an ultrasonic / bipolar RF energy combined surgical device. The ultrasonic / bipolar RF energy combined surgical device includes an end effector. The end effector includes a clamping arm and an ultrasonic blade. The clamping arm includes a movable clamping jaw, a shape conforming polymer pad, and at least one bipolar RF electrode. 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 various aspects, the end effector includes an electrode biasing mechanism.

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

[0040] In one aspect, the present disclosure provides a limited electrode biasing mechanism for preventing the ultrasonic blade from damaging the electrode. Generally, in various aspects, the present disclosure provides an end effector for use with an ultrasonic / RF combined device, the end effector including an electrode. In one aspect, the ultrasonic / bipolar RF energy combined 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 at its proximal end to the clamping jaw and is free to deflect at its distal end. Thus, throughout the present disclosure, the electrode can be referred to as a cantilever beam electrode or a deflectable electrode.

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

[0042] In one aspect, an ultrasonic / RF energy composite surgical device includes an ultrasonic blade, a clamp arm, and at least one electrode extending across the ultrasonic blade. In one aspect, the electrode is configured to be deflectable relative to the clamp arm and includes a functional portion for changing mechanical properties of tissue compressed between the electrode and the ultrasonic blade. In another aspect, the electrode includes a functional portion for preventing inadvertent contact between the electrode and the ultrasonic blade to prevent or minimize damage to the electrode by the ultrasonic blade.

[0043] In various aspects, the electrode includes a metal spring element attached to the proximal end of the clamp jaw of the end effector. The metal spring element defines an opening through which one or more clamp arm pads (also known as "tissue pads" or "clamp tissue pads") are received. The metal spring element also includes an integrated minimum gap element. This configuration of the electrode provides a way to prevent tissue from accumulating around the biasing mechanism, which could potentially affect the performance of the electrode. This configuration also minimizes the coupling between the wear pad and the biasing spring, increases the strength of the connection of the electrode to the clamp arm, minimizes the inadvertent release of the clamp arm pad by attaching a polyimide pad to the electrode, and harmonizes the balance of surface area / current density between the electrodes. The electrode is fixed at the proximal end to the clamp jaw and is free to deflect at the distal end. Thus, throughout the present disclosure, the electrode is deflectable and may be referred to as a cantilever beam electrode or a deflectable electrode.

[0044] Figures 1-9 illustrate one aspect of an end effector comprising a deflectable / cantilever electrode configured for use with an ultrasonic / bipolar RF energy composite device, according to at least one aspect of the present disclosure. FIG. 1 is a perspective view of a portion of a clamp arm 1000 of an end effector for use with an ultrasonic / RF composite device, according to at least one aspect of the present disclosure. For purposes of brevity and clarity of the disclosure, the ultrasonic blade that functions 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 and causing damage or short circuit of the blade. The tissue being treated is clamped and compressed between the clamp arm 1000 and the ultrasonic blade.

[0045] The clamp arm 1000 includes a frame 1002, an electrode 1004, at least one small non-conductive gap pad 1006, at least one large non-conductive gap pad 1008, and at least one non-conductive clamp arm pad 1010. In one aspect, the small gap pad 1006 and the large gap pad 1008 are configured to set a gap between the electrode 1004 and the ultrasonic blade. The clamp arm pad 1010 is configured to grip tissue between the clamp arm 1000 and the ultrasonic blade to assist in sealing and cutting the tissue. In other aspects, the small and large non-conductive gap pads may be interchanged. In other aspects, the non-conductive gap pads are each simply sized differently, regardless of the relative size difference between the non-conductive gap pads.

[0046] The pivotal movement of the clamping arm 1000 relative to the end effector is effected by providing, at its proximal end 1014, at least one, and preferably a pair of, lever portions 1012 of the frame 1002 of the clamping arm 1000. The lever portions 1012 are disposed on opposite sides of the ultrasonic waveguide and the end effector, respectively, and are operatively engaged with the drive portion of the reciprocating member. Thereby, the reciprocating movement of the operating member relative to the outer tubular sheath and the ultrasonic waveguide causes the clamping arm 1000 to pivot relative to the end effector about the pivot point 1016. The lever portions 1012 can be respectively disposed within a pair of openings defined by the drive portion or otherwise suitably mechanically coupled to the drive portion, whereby the reciprocating movement of the operating member serves to pivot the clamping arm 1000 through the drive portion and the lever portions 1012.

[0047] Figure 2 is an exploded view of the clamp arm 1000 shown in Figure 1, according to at least one aspect of the present disclosure. In various aspects, the electrode 1004 is made of a metallic spring material and is attached to the proximal end 1014 of the frame 1002 of the clamp arm 1000 such that the electrode 1004 can be deflected. The metallic spring electrode 1004 defines an opening 1018 through which an element of the clamp arm pad 1010 is received. The metallic spring electrode 1004 defines additional openings 1020, 1021 through which the gap pads 1006, 1008 are received. Thereby, a minimum gap is set between the electrode 1004 and the ultrasonic blade. At least one of the gap pads 1006 is disposed on the distal end 1022 of the electrode 1004. Thus, the gap pads 1006, 1008 are integrated with the electrode 1004. In this configuration, the electrode 1004 prevents tissue from accumulating around a biasing mechanism, such as a cantilever spring, as such accumulation could negatively affect the performance of the electrode 1004. This configuration also minimizes the coupling between the wearable clamp arm pad 1010 and the biasing spring electrode 1004, increases the strength of the connection of the electrode 1004 to the clamp arm, minimizes an unintentional release of the clamp arm pad 1018 by attaching the gap pads 1006, 1008 to the electrode 1004, and harmonizes the surface area / current density balance between the electrodes. The electrode 1004 is attached to the frame 1002 by two protrusions 1024. The electrode protrusions 1024 are attached to the proximal end 1014 of the frame 1002 as shown in Figures 3 and 4.

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

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

[0050] FIG. 6 is 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 that project from a backbone 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 opening 1028 at a location where the gap pad 1006 is positioned on the electrode 1004. Referring also to FIGS. 8 and 9, the opening 1028 defined by the clamp arm pad 1010 is sized and configured to receive a protrusion 1036 defined at a bottom portion of the gap pad 1006. In one aspect, the material of the clamp arm pad 1010 is softer than the materials of the gap pads 1006, 1008. In one aspect, the clamp arm pad 1010 is made of a non-stick and lubricious material such as polytetrafluoroethylene (PTFE) or a similar synthetic fluoropolymer of tetrafluoroethylene. PTFE is a hydrophobic, non-wetting, high-density, high-temperature resistant, multi-purpose material with non-stick properties. In contrast, the gap pads 1006, 1008 are made of a polyimide material and, in one aspect, are made of a highly durable high-performance polyimide-based plastic, known by the trade name VESPEL, manufactured by DuPont, for example, or, for example, other suitable polyimides, polyimide polymer alloys, or PET (polyethylene terephthalate), PEEK (polyetheretherketone), PEKK (polyetherketoneketone) polymer alloys. Unless otherwise described separately below, the clamp arm pads and gap pads described hereinbelow are made of the materials described in this paragraph.

[0051] FIG. 7 is a perspective top view of the 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. FIG. 8 is a perspective top view of the small gap pad 1006 according to at least one aspect of the present disclosure. FIG. 9 is a perspective bottom view of the small gap pad 1006 shown in FIG. 8. As shown in FIGS. 8 and 9, the small gap pad 1006 includes a protrusion 1036 at the bottom, and the protrusion 1036 is sized and configured to be received within an opening 1020 defined by the electrode 1004 and an opening 1028 defined by the clamp arm pad 1010. The small gap pad 1006 and the large gap pad 1008 are made of a polyimide material and, in one aspect, are made of a highly durable high-performance polyimide-based plastic known by the trade name VESPEL, manufactured by DuPont. The durability of the polyimide material ensures that the electrode gap remains relatively constant assuming normal wear and tear.

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

[0053] To overcome these and other limitations, various aspects of the present disclosure incorporate a deflectable RF electrode in combination with a clamp arm pad that includes a non-stick, lubricious, flexible (e.g., PTFE) pad secured to the clamp arm. The RF electrode includes a wear-resistant non-conductive pad that contacts the blade to set a gap between the blade and the electrode. The flexible clamp arm pad extends through an opening defined by the electrode and reacts to the clamping force from the ultrasonic blade. As the flexible clamp arm pad wears, the electrode deflects to maintain a constant gap between the blade and the electrode. Such a configuration provides a consistent gap between the electrode and the ultrasonic blade throughout the life of the device, prevents short circuits and damage to the ultrasonic blade that can occur when the ultrasonic blade contacts the electrode, and allows the electrode material to be placed directly on the side facing the ultrasonic blade to improve sealing performance. The electrode is fixed at the proximal end to the clamp jaw and is free to deflect at the distal end. Thus, throughout the present disclosure, the electrode may be referred to as a cantilever beam electrode, or a deflectable electrode.

[0054] In one aspect, the present disclosure provides an asymmetric cooperation of the clamp arm / electrode / pad to effect an interaction between the ultrasonic blade and the RF electrode. In one aspect, the present disclosure provides a shortened clamp arm. FIGS. 10-12 illustrate an end effector with a shortened clamp arm for deflectable / cantilever electrode applications according to various aspects of the present disclosure. In one aspect, the end effector is configured for an asymmetric cooperation of the clamp arm, the electrode, and the clamp arm pad to effect an interaction between the ultrasonic blade and the RF electrode. The electrode is adapted and configured for use with an ultrasonic / bipolar RF energy composite surgical device and is deflectable when loaded. This electrode is one pole of a bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0055] In one aspect, the distal end of the clamp arm is shortened, but the length of the clamp arm pad is maintained at its original length, such that the distal end of the clamp arm pad extends beyond the distal end of the clamp arm. This allows the electrode to overextend, minimizing the possibility of electrically shorting the distal end of the clamp arm. Also, since the exposed clamp arm pad material is added to wear out completely, there may be an advantage of extending the life of the clamp arm pad. This configuration also eliminates the use of the clamp arm pads for gap setting at the distal and intermediate positions, previously mentioned herein as wear-resistant clamp arm pads for setting and maintaining the gap, for example, between the electrode and the ultrasonic blade.

[0056] FIG. 10 is a side view of an end effector 1680 comprising a shortened clamp arm 1682, an ultrasonic blade 1684, an electrode 1686, and a clamp arm pad 1688, according to at least one aspect of the present disclosure. FIG. 11 is a top view of the end effector 1680. As shown in FIGS. 10-11, the ultrasonic blade 1684 and the electrode 1686 are substantially the same length. The clamp arm 1682 is shortened to allow the electrode 1686 to 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.

[0057] FIG. 12 shows 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. There is an empty space above the distal side of the clamp arm. The clamp arm 1700 is configured to be used with an end effector including an ultrasonic blade, as disclosed in other sections of this specification. This configuration leaves the space 1708 above the distal side of the clamp jaw 1702 empty. The clamp arm pad 1706 (e.g., PTFE) is fully supported thereunder, but an empty space exists within the t-slot region and on the side walls, allowing more of the clamp arm pad 1706 to melt away and allowing the electrode 1704 to deflect further away from an ultrasonic blade (not shown).

[0058] In one aspect, the present disclosure provides an end effector that uses 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 ultrasonic blade, and as the clamp arm pad expands or changes shape due to pressure or heat, the thermal expansion characteristics of the clamp arm pad material (e.g., PTFE) can be utilized to deflect the electrode away from the path of the ultrasonic blade.

[0059] In one aspect, a non-biased electrode and pad are provided. The pad, while non-biased but deflectable, changes position relative to the clamp arm as the pad wears. The non-biased electrode is configured to minimize contact between the ultrasonic blade and the RF electrode. The clamp arm pad includes a feature for securing the electrode to the clamp arm pad. In one aspect, as the height of the clamp arm pad wears or is cut, the height of the electrode relative to the clamp arm is gradually adjusted. In another aspect, once the clamp arm moves 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 deflects freely at the distal end. Thus, throughout the present disclosure, the electrode can be referred to as a cantilever beam electrode or a deflectable electrode.

[0060] The configuration of the end effector including the deflectable / cantilever electrode described above with respect to FIGS. 1-12 can be combined with the biasing electrode as described below with respect to FIGS. 13-18.

[0061] In one aspect, the present disclosure provides an end effector for an ultrasonic / bipolar RF energy composite surgical device that uses pressure or compression by a clamp jaw to adjust the height of the electrode as the clamp arm pad wears. In one aspect, the clamp arm pad follows an electrode biased by a clamp arm having a wearable stop. In one aspect, the clamp arm pad includes a function for fixing the electrode to the pad. As the height of the pad wears or is cut, the height of the electrode relative to the clamp arm is gradually adjusted. As the clamp arm moves away from the ultrasonic blade, the electrode remains in its new position.

[0062] Achieving sufficient clamp arm pad life on an ultrasonic / bipolar RF energy composite surgical device requires maintaining a gap between the clamp arm pad and the electrode that is small enough but non-zero throughout the life of the instrument to provide the desired ultrasonic and bipolar RF effects on tissue. The electrode is adapted and configured for use with an ultrasonic / bipolar RF energy composite surgical device and is deflectable when loaded. This electrode is one pole of the bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0063] Existing (seed) electrodes are flat electrodes that are horizontal or substantially parallel to the clamp arm in a free state (no load). The electrode is fixed to the clamp arm at the proximal end and deflects freely at the distal end. Thus, throughout the present disclosure, the electrode may be referred to as a cantilever beam electrode or a deflectable / cantilever electrode. When the tissue is clamped, the tissue loads the electrode and the electrode deflects toward the clamp arm.

[0064] In one aspect, when the pad wears, the electrode “follows” it. In this aspect, the electrode is biased towards the clamping arm in a free state (whether it is a formed / bent electrode or the electrode is attached / welded non-parallel to the clamping arm), and among other fastening techniques, any suitable fastening technique such as welding, laser welding, brazing, soldering, pressing, etc. is used. The wearable stop function (on the pad or elsewhere) keeps the electrode away from the clamping arm until the stop function wears out during use. Once this wears out, the electrode can approach the clamping arm. These functional parts can be in the form of teeth or ratchet shapes, vertically tapered, or others.

[0065] In one aspect, the present disclosure provides a deflectable / cantilever electrode which, in a free state, is biased towards the clamping arm, can be attached at an angle, and can be made with a pre-formed curve. In this case, any suitable fastening technique such as welding, laser welding, brazing, soldering, compression, etc. is used among other fastening techniques.

[0066] In one aspect, the present disclosure provides an end effector comprising a deflectable / cantilever electrode with a wearable stop function to prevent the electrode from reaching or contacting the clamping arm. When the stop function wears, the electrode moves towards the clamping arm until it reaches the next stop function. In one aspect, the stop function wears simultaneously with the clamping arm pad to maintain an appropriate gap between the clamping arm pad and the electrode. These functional parts can be completely separated from the clamping arm pad. These functional parts can withstand the clamping load but can be configured to wear more by heat (melting / flowing) or by friction. Possible examples include teeth on one or more clamping arm pads (PTFE, polyimide, or others), and tapered profiles on one or more clamping arm pads (PTFE, polyimide, or others).

[0067] FIG. 13 shows an end effector clamp arm 1710 comprising a clamp jaw 1712, an electrode 1714, and a clamp arm pad 1716, according to at least one aspect of the present disclosure. The clamp arm 1710 is configured for use with an end effector comprising an ultrasonic blade (not shown), as described throughout the present disclosure. The clamp arm 1710 also includes a wear-resistant gap pad 1717 for setting a gap between the electrode 1714 and the ultrasonic blade. As shown, in a free state, the electrode 1714 is biased in a flat or horizontal 1718 orientation without inclination. The electrode 1714 is fixed to the clamp jaw 1712 at the proximal end and deflects freely at the distal end. Thus, throughout the present disclosure, the electrode 1714 may be referred to as a cantilever beam electrode, or a deflectable electrode.

[0068] FIG. 14 shows an end effector clamp arm 1720 comprising a clamp jaw 1722, an electrode 1724, and a clamp arm pad 1726, according to at least one aspect of the present disclosure. The clamp arm 1720 is configured to be used with an end effector comprising an ultrasonic blade (not shown), as described throughout the present disclosure. The clamp arm 1720 also includes a wear-resistant gap pad 1727 for setting a gap between the electrode 1724 and the ultrasonic blade. As shown, in a free state, the electrode 1724 is pre-formed in a certain shape, bent and configured, or otherwise deflected away from a horizontal 1718 orientation along line 1728 towards the clamp jaw 1722. The electrode 1724 is fixed to the clamp arm 1720 at its proximal end and is free to deflect at its distal end. Thus, throughout the present disclosure, the electrode 1724 may be referred to as a cantilever beam electrode, or a deflectable electrode. To prevent the biasing electrode 1724 from bending towards the clamp jaw 1722 under the biasing force, the clamp arm 1720 further includes a retainer that prevents the biasing electrode 1724 from bending towards the clamp jaw 1722 and maintains the bias electrode 1724 in a substantially flat configuration (e.g., parallel, flat, or horizontal) relative to the ultrasonic blade. Examples of retainers such as retainer teeth 1738 and a retainer wall 1760 having a tapered profile are described below with reference to FIGS. 15-18.

[0069] FIG. 15 shows an end effector clamp arm 1730 comprising a clamp jaw 1732, an electrode 1734, and a clamp arm pad 1736, according to at least one aspect of the present disclosure. The clamp arm 1730 is configured for use with an end effector comprising an ultrasonic blade (not shown), as described throughout the present disclosure. The clamp arm 1730 also includes a wear-resistant gap pad 1737 for setting a gap between the electrode 1744 and the ultrasonic blade. In a free state, the electrode 1734 is configured to be pre-formed, bent, or otherwise biased into a curved shape toward the clamp jaw 1732. However, a retainer tooth 1738 or similar feature is provided on the clamp arm pad 1736 to prevent the electrode 1734 from springing toward the clamp jaw 1732. In FIG. 16, according to at least one aspect of the present disclosure, when the bottom retainer tooth 1738 wears down, the electrode 1734 can move toward the clamp jaw 1732 by a pre-formed curve. The electrode 1734 is fixed to the clamp arm 1730 at its proximal end and is free to deflect at its distal end. Thus, throughout the present disclosure, the electrode 1734 may be referred to as a cantilever beam electrode, or a deflectable electrode.

[0070] FIG. 17 shows an end effector clamp arm 1750 comprising a clamp jaw 1752, an electrode 1754, and a clamp arm pad 1756, according to at least one aspect of the present disclosure. The clamp arm 1750 is configured for use with an end effector comprising an ultrasonic blade (not shown), as described throughout the present disclosure. The clamp arm 1750 also includes a wear-resistant gap pad 1757 for setting a gap between the electrode 1754 and the ultrasonic blade. In a free state, the electrode 1754 is configured to be pre-formed, bent, or otherwise biased 1758 to have a shape that curves toward the clamp jaw 1752. However, a retainer wall 1760 having a tapered profile or similar feature is provided on the clamp arm pad 1756 to prevent the electrode 1754 from springing toward the clamp jaw 1752.

[0071] In FIG. 17, according to at least one aspect of the present disclosure, when the tapered-profile retainer wall 1760 wears down, there is sufficient melt / flow away from the tapered-profile retainer wall 1760 region such that, due to the pre-formed curve, the electrode 1754 is able to move toward the clamp jaw 1752. The electrode 1754 is fixed to the clamp jaw 1752 at its proximal end and freely deflects at its distal end. Thus, throughout the present disclosure, the electrode 1754 may be referred to as a cantilever beam electrode or a deflectable electrode.

[0072] In one aspect, the present disclosure provides an end effector for an ultrasonic / bipolar RF energy composite surgical device that uses a constant pressure distribution biasing mechanism. In one aspect, the end effector includes an elastic compressive support for mounting and insulating a deflectable electrode. In one aspect, a hollow honeycomb-shaped or elastomeric support mounting cushion having chambers is used to enable all or a portion of the electrodes attached thereto to deflect or be biased toward an ultrasonic blade. This configuration can provide the additional advantage of thermally isolating the electrodes from the remainder of the metal clamp jaws. This also provides an elastomeric "curtain" around the electrodes to minimize tissue accumulation behind the electrodes. In one aspect, a deflectable geometry without struts for the elastomeric cells enables maintaining a constant biasing force over a predetermined range of deflection. The electrode is adapted and configured for use with an ultrasonic / bipolar RF energy composite surgical device and is deflectable when loaded. This electrode is one pole of a bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0073] The above configuration prevents the electrode from bending laterally under compression and prevents short circuits. Further, the deflectable electrode is attached to the elastomer, and the elastomer is fixed to the metal clamp arm. The spring contact height is limited by driving an acceptable compression while maintaining as much of the metal clamp arm as possible. Heat conduction from the tissue interface is balanced and minimized, affecting the formation and symmetry of the denatured portion, cycle time, and residual heat energy.

[0074] The configuration of the end effector with the deflectable / cantilever electrode described above with respect to FIGS. 1-12 can be combined with a flexible electrode disposed above a grid cushion and a plurality of hard spacers, as described below with respect to FIGS. 19-21, thereby setting a gap between the flexible electrode and the ultrasonic blade.

[0075] The configuration of the biasing electrode as described above with respect to FIGS. 13 to 18 can be combined with a flexible electrode disposed above the grid cushion and a plurality of hard spacers as will be described below with respect to FIGS. 19 to 21, thereby setting a gap between the flexible electrode and the ultrasonic blade.

[0076] The configuration of the end effector having the deflectable / cantilever electrode as described above with respect to FIGS. 1 to 12 in combination with the biasing electrode as described above with respect to FIGS. 13 to 18 can be combined with a flexible electrode disposed above the grid cushion and a plurality of hard spacers as will be described below with respect to FIGS. 19 to 21, thereby setting a gap between the flexible electrode and the ultrasonic blade.

[0077] FIGS. 19 to 20 show an end effector 1810 comprising a clamp arm 1812, an ultrasonic blade 1814, a grid cushion 1816, a flexible electrode 1818 disposed above the grid cushion 1816, and a plurality of hard spacers 1820 for setting a gap between the flexible electrode 1818 and the ultrasonic blade 1814, according to at least one aspect of the present disclosure. FIG. 21 is an exploded view of the end effector 1810 shown in FIGS. 19 to 20. The clamp arm pad 1822 is disposed inside a slot 1825 formed in the grid cushion 1816. The grid cushion 1816 functions as a spring-like element. The hard spacers 1820 are used to set a gap between the flexible electrode 1818 and the ultrasonic blade 1814.

[0078] In FIG. 19, the clamp arm 1812 is open, and a tissue 1824 of non-uniform thickness (T 1a , T 2a , T 3a ) is disposed covering the flexible electrode 1818. In FIG. 20, the clamp arm 1812 is closed and compresses the tissue 1824. The grid cushion 1816 on the clamp arm 1812 has a thickness (T 1a , T 2a , T 3a) across the tissue 1824, with a consistent thickness (T 1b 、T 2b 、T 3b ) resulting in the tissue 1824, i.e., realizing a compression for which the following relationship holds:

[0079]

Number

[0080] Additional background disclosure can be found in European Patent No. 3378427 and International Patent Application Publication No. 2019 / 006068, which are hereby incorporated by reference in their entirety.

[0081] In one aspect, the present disclosure provides an end effector for an ultrasonic / bipolar RF energy composite surgical device with means for ensuring that the biasing electrode and the distal tip do not come into contact using a zero-gap bipolar RF energy system. In various aspects, the present disclosure provides a deflectable electrode for an ultrasonic / bipolar RF energy composite surgical device having a distal biasing force greater than the proximal biasing force. In one aspect, the present disclosure provides an energy composite device comprising a bipolar electrode deflectable with respect to a clamp arm. The energy composite device comprises a functional portion that varies the mechanical properties of tissue compression from proximal to distal, creating a more uniform or more different pattern of pressure than by the clamping force alone. In one aspect, the present disclosure provides a non-linear distal distribution mechanism, and in another aspect, the present disclosure provides a non-linear distribution of electrical energy density. The electrode is adapted and configured for use with an ultrasonic / bipolar RF energy composite surgical device and is deflectable when loaded. This electrode is one pole of a bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0082] The configuration of the end effector including the deflectable / cantilever electrode described above with respect to FIGS. 1 to 12 can be combined with a clamp arm pad made of a conductive polymer as described below with respect to FIGS. 22 to 36.

[0083] The configuration of the biasing electrode as described above with respect to FIGS. 13 to 18 can be combined with a clamp arm pad made of a conductive polymer as described below with respect to FIGS. 22 to 36.

[0084] As described above with respect to FIGS. 19 to 21, the configuration of the flexible electrode and the plurality of hard spacers disposed above the lattice cushion for setting a gap between the flexible electrode and the ultrasonic blade can be combined with a clamp arm pad made of a conductive polymer as described below with respect to FIGS. 22 to 36.

[0085] The configuration of the biasing electrode as described above with respect to FIGS. 13 to 18 can be combined with the flexible electrode and the plurality of hard spacers disposed on the lattice cushion as described above with respect to FIGS. 19 to 21 to set a gap between the flexible electrode and the ultrasonic blade, and furthermore, can be combined with a clamp arm pad made of a conductive polymer as described below with respect to FIGS. 22 to 36.

[0086] The configuration of the biasing electrode as described above with respect to FIGS. 13 to 18 can be combined with the flexible electrode and the plurality of hard spacers disposed on the lattice cushion as described above with respect to FIGS. 19 to 21 to set a gap between the flexible electrode and the ultrasonic blade, and furthermore, can be combined with a clamp arm pad made of a conductive polymer as described below with respect to FIGS. 22 to 36.

[0087] The configuration of the end effector including the deflectable / cantilever electrode described above with respect to FIGS. 1 to 12 in combination with the biasing electrode described above with respect to FIGS. 13 to 18 can be combined with a clamp arm pad made of a conductive polymer as described below with respect to FIGS. 22 to 36.

[0088] The configuration of an end effector comprising a deflectable / cantilever electrode as described above with respect to FIGS. 1-12, in combination with a biasing electrode as described above with respect to FIGS. 13-18, can be combined with a flexible electrode disposed above a grid cushion and a plurality of hard spacers to set a gap between the flexible electrode and an ultrasonic blade as described above with respect to FIGS. 19-21, and furthermore, can be combined with a conductive polymer clamp arm pad as will be described below with respect to FIGS. 22-36.

[0089] In various aspects, the present disclosure provides an ultrasonic / bipolar RF energy composite surgical device comprising an ultrasonic pad having a partially or fully conductive portion, the pad serving as both a blade support / wear pad and a bipolar RF electrode. In one aspect, the present disclosure provides a clamp arm pad having partial conductivity, the pad allowing for wear of the electrode and minimizing short circuits in a bipolar RF and ultrasonic energy composite device in which the clamp arm pad has conductive and non-conductive portions. Thereby, this clamp arm pad functions as a wearable support structure for the ultrasonic blade while also being able to function as one of the RF electrodes. In another aspect, the present disclosure provides a conductive portion around the clamp arm pad, but this conductive portion is not located on the side directly facing the contact area of the ultrasonic blade. In another aspect, a portion of the conductive clamp arm pad is decomposable or wearable, preventing contact from the ultrasonic blade from interrupting the conductivity of the remaining portion of the conductive clamp arm pad.

[0090] In one aspect, the present disclosure provides an end effector for an ultrasonic / bipolar RF energy composite surgical device comprising a conductive polymer ultrasonic clamp arm pad. In one aspect, the end effector comprises a clamp arm pad doped with tin oxide. FIG. 22 is a cross-sectional view of a conductive polymer clamp arm pad 2440 according to at least one aspect of the present disclosure. The conductive polymer clamp arm pad 2440 includes tin oxide 2442 (SnO2) embedded in a polymer material 2444 such as Teflon (PTFE) to make the clamp arm pad 2440 conductive. Doping can be achieved using a cold spray process. When doping is performed, the conductive polymer clamp arm pad 2440 can, for example, come into contact with an ultrasonic blade, absorb heat from the ultrasonic blade, and perform the functions of a conventional ultrasonic tissue clamp arm pad, such as assisting in grasping and clamping tissue. The clamp arm pad 2440 doped with tin oxide functions as one of two electrodes or poles of a bipolar RF circuit to deliver RF energy to tissue gripped between the ultrasonic blade and the clamp arm pad 2440. The clamp arm pad 2440 doped with tin oxide is biocompatible, conductive, thermally conductive, can improve the wear resistance of the clamp arm pad 2440 using most of the clamp arm pad 2440, and is white. The electrode is adapted and configured for use with an ultrasonic / bipolar RF energy composite surgical device and is deflectable when loaded. This electrode is one pole of a bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0091] In one aspect, the present disclosure provides a conductive polymer ultrasonic clamp arm pad as an alternative to an electrode. To improve the life of the ultrasonic clamp arm pad and the effect of RF on tissue, the present disclosure provides electrodes that are improved, easier to fabricate, and less costly to fabricate. In one aspect, the present disclosure provides a clamp arm pad that includes a rigid polyimide polymer layer and a conductive layer, enabling the clamp arm pad to achieve conventional functions and eliminating the need to provide separate electrodes within the clamp arm of an energy composite end effector. In this way, the clamp jaws can be manufactured in the same manner as ultrasonic-only clamp jaws, and the new clamp arm pad material will be interchangeable with conventional ultrasonic-only clamp arm pads. The electrode is adapted and configured to be used with an ultrasonic / bipolar RF energy composite surgical device and is deflectable when loaded. This electrode is one pole of a bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0092] Advantages include improved ultrasonic performance, including wear of the clamp arm pad, similar to current ultrasonic-only instruments, since there is no electrode gap between the "phalanxes" of polymer elements. The cost of the improved clamp jaws is similar to current ultrasonic-only clamp jaws since separate electrode components are eliminated and multiple small polymer phalanx elements are provided. In addition, the manufacturing steps required to fabricate the clamp jaws are the same as those required to fabricate current ultrasonic-only clamp jaws. Manufacturing the improved clamp jaws requires only replacement of the clamp arm pad and does not require the manufacture of additional electrode components added to the clamp jaws and eliminates the assembly step.

[0093] FIG. 23 is a perspective view of a clamp arm pad 2450 configured to replace a conventional electrode, according to at least one aspect of the present disclosure. The clamp arm pad 2450 includes a non-conductive layer 2452 and a conductive layer 2454 in a sandwich-like configuration. This configuration eliminates the need for a spring-loaded electrode plate. The non-conductive layer 2452 can be made of a polymer, polyimide, Teflon (PTFE), and similar non-conductive materials. The conductive layer 2454 can be made of a thin conductive polymer, metal foil, or carbon-filled material. The clamp arm pad 2450 can be manufactured such that the majority of the material in contact with the ultrasonic blade is the non-conductive layer 2452. In one aspect, 75% of the material in contact with the ultrasonic blade is a non-conductive material such as PTFE. In another aspect, 85% of the material in contact with the ultrasonic blade is a non-conductive material such as PTFE. In yet another aspect, 95% of the material in contact with the ultrasonic blade is a non-conductive material such as PTFE. Also, as the clamp arm pad 2450 wears, the conductive layer 2452 still has a surface area available for conducting RF electricity through the tissue and the return electrode (e.g., the ultrasonic blade).

[0094] FIG. 24 shows a clamp arm 2460 including the clamp arm pad 2450 described in FIG. 23, according to at least one aspect of the present disclosure. In the illustrated clamp arm 2460, the non-conductive layer 2452 has a larger surface area compared to the conductive layer 2454, which appears as a thin layer or foil.

[0095] FIG. 25 shows clamp arm pads configured as described in FIGS. 23-24, according to at least one aspect of the present disclosure. The first clamp arm pad 2470 is new and 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.

[0096] In one aspect, the present disclosure provides a composite clamp arm pad for an ultrasonic / bipolar RF energy composite surgical device. FIG. 26 is a cross-sectional view of a clamp arm 2480 comprising a composite clamp arm pad 2482 in contact with tissue 2484, according to at least one aspect of the present disclosure. The end effector 2480 includes an upper clamp jaw 2486 and an adhesive 2488 for fixedly attaching the composite clamp arm pad 2482 to the upper clamp jaw 2486. The composite clamp arm pad 2482 includes a thin non-conductive layer 2490 (e.g., PTFE) and a thin conductive layer 2492 (e.g., a thin stainless steel foil). The conductive layer 2492 forms the electrode portion of the composite clamp arm pad 2482. The conductive layer 2492 (e.g., a thin stainless steel foil) deforms as the non-conductive layer 2490 (e.g., PTFE) wears. The thickness of the conductive layer 2492 allows the electrode portion of the composite clamp arm pad 2482 to deform as the non-conductive layer 2490 wears away. Advantageously, the conductive layer 2492 conducts and takes away some of the heat from the non-conductive layer 2490, keeping the composite clamp arm pad 2482 at a lower temperature. As described above, the composite clamp arm pad 2482 is fixed to the upper clamp jaw 2486 by an adhesive 2488. The adhesive 2488 is filled with carbon to make the adhesive 2488 conductive and connect the electrode portion of the composite clamp arm pad 2482 to the upper clamp jaw 2486. The electrode is adapted and configured for use with an ultrasonic / bipolar RF energy composite surgical device and is deflectable when a load is applied. This electrode is one pole of a bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0097] In one aspect, the clamp arm pad comprises a conductive portion and an insulating portion that cooperate. In one aspect, the present disclosure provides an ultrasonic / bipolar RF energy composite surgical device in which the clamp arm pad functions as a wearable support structure for the ultrasonic blade, while the presence of the conductive and non-conductive portions enables the clamp arm pad to function as one of the RF electrodes. In another aspect, the conductive portion of the clamp arm pad is located around the pad and not on the directly opposing side of the ultrasonic blade contact area. In another aspect, the conductive portion of the clamp arm pad is decomposable or wearable, and contact with the ultrasonic blade prevents interruption of the conductivity of the remaining conductive portion of the clamp arm pad.

[0098] In one aspect, the present disclosure provides a clamp arm pad for use with an ultrasonic / bipolar RF energy composite device, with a portion of the clamp arm pad including a conductive material and another portion including a non-conductive material. The electrode is adapted and configured for use with an ultrasonic / RF energy composite device and is deflectable under load. This electrode is one pole of a bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0099] In various aspects, the clamp arm pad can be manufactured using various techniques. One technique involves a two-shot process of molding conductive and non-conductive materials within the same compression mold. This process effectively creates a clamp arm pad that has a portion that can act as a bipolar RF electrode and another portion that functions as an electrical insulator. Another technique involves embedding metal elements into a polymer (e.g., Teflon, PTFE) pad or matrix by supersonic cold spraying. Another technique involves 3D printing of multiple materials (e.g., Teflon, PTFE, and doped conductive polymers), printing / transfer printing of conductive or functional inks onto the clamp arm pad. Another technique involves that metals and conductive materials (e.g., graphite / carbon) can be applied to the clamp arm pad using chemical vapor deposition, physical vapor deposition, sputter deposition, vacuum deposition, vacuum metallization, or thermal spraying. Another technique involves a conductive / filled clamp arm pad electrode that provides continuity through a pad having micro-randomly oriented and positioned particles or a macro-oriented structure (e.g., cloth, woven fabric, constrained long fibers). Another technique involves making the surface of the clamp arm pad conductive, including, among other techniques, providing a wearing electrode, 3D printing, thermal spraying, cold spraying, coating / painting / epoxy, sheet / foil / wire / film wrapping or laminating, vacuum metallization, printing / transfer, etc. In another technique, the polymer electrode is filled with a conductive material.

[0100] In one aspect, the end effector clamp arm comprises a fixed polymer electrode. FIG. 27 shows a clamp arm 2500 that includes a clamp jaw 2502 attached to a carrier 2504 or a stamping supporting a clamp jaw 2502 according to at least one aspect of the present disclosure, and a clamp arm pad 2506. The clamp 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 functions as one of the electrodes of a bipolar RF circuit. The clamp jaw 2502 and the carrier 2504 are made of stainless steel and can be attached using any suitable fastening technique, such as welding, laser welding, brazing, soldering, pressing, etc., among other fastening techniques. The conductive pad 2508 can include a polymer such as, for example, silicone, fluorosilicone, PTFE, and similar materials. The conductive pad 2508 is overmolded onto the carrier 2504 using PTFE, silicone, fluorosilicone filled with silver particles, silver on aluminum, silver on copper, copper, nickel, graphite, carbon (amorphous, short fiber), gold, platinum, stainless steel, iron, or zinc, or combinations thereof.

[0101] FIG. 28 is a cross-sectional view taken along the cut plane 28-28 in FIG. 27, and FIG. 29 is a cross-sectional view taken along the cut plane 29-29 of FIG. 27. Cross-sectional views 28-28 and 29-29 show a clamp arm 2500 that includes a clamp jaw 2502, a support carrier 2504, a conductive pad 2508, and a non-conductive pad 2510.

[0102] FIG. 30 is a cross-sectional view of an alternative implementation of a clamp arm 2520 that includes a clamp jaw 2522, a conductive pad 2524, and a non-conductive pad 2526 according to at least one aspect of the present disclosure. The conductive pad 2524 is made of a conductive polymer and functions as one of the electrodes within a bipolar RF circuit.

[0103] FIG. 31 is a cross-sectional view of an alternative implementation of a clamp arm 2530 including a clamp jaw 2532, a carrier 2534 or stamping welded to the clamp jaw 2532, a conductive pad 2536, and a non-conductive pad 2538, according to at least one aspect of the present disclosure. The conductive pad 2536 is made of a conductive polymer and functions as one of the electrodes in a bipolar RF circuit. The conductive pad 2536 is overmolded onto the carrier 2534 or stamping.

[0104] In one aspect, the end effector clamp arm includes a film on an insert molded metal electrode assembly. In one aspect, the film can be provided on an insert molded metal (e.g., stainless steel) electrode assembly. A film can be insert molded onto a metal such as stainless steel to form an electrode assembly. The film on the insert molded electrode can be etched to form, among other patterns, micro-holes, slots, honeycombs, etc., to conduct RF energy and cut around components. The film can be formed or bonded onto the stainless steel electrode using the IML / FIM (in-mold labeling / film insert molding) process described below. The filled film electrodes can be placed into a polymer injection molding tool to mold the polymer onto the back of the electrodes and the film. The electrodes are adapted and configured for use with an ultrasonic / bipolar RF energy composite surgical device and are deflectable when loaded. This electrode is one pole of a bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0105] FIG. 32 shows an insert - molded electrode 2540 according to at least one aspect of the present disclosure. The insert - molded electrode 2540 includes a conductive element 2546, a molded polymer pad 2548, and a coating by a film 2542. Functional features 2550 such as micro - holes, slots, honeycombs, or similar functional features are formed in the film 2542 to allow the passage of RF energy. A holding feature 2552 is also formed on the film 2542. The sidewall 2558 of the film 2542 may extend under the bottom of the polymer pad 2548 and may be folded around the bottom of the polymer pad 2548 or over - molded with holding posts. The holding mechanism 2552 is molded into a hole 2554 defined by the film 2542. Two insert - molded electrodes 2540 are shown with a gap between them, but in practice, the two insert - molded electrodes 2540 are fitted between lines 2556 via mold pressure.

[0106] The conductive element 2546 can be manufactured from a conductive metal, such as stainless steel or a similar conductive metal. The conductive element 2546 may be about 0.010 inches thick, may be selected within the range of 0.005 inches to 0.015 inches thick, and can be formed by stamping or machining. The film 2544 may be about 0.001 inches to 0.002 inches thick and can be manufactured from polyimide, polyester, or a similar material. Alternatively, for mechanical holding such as posts, the film 2544 can be directly bonded to the conductive element 2546. As an example, a DuPont Pyralux HXC Kapton film with an epoxy adhesive backing having a thickness of 0.002 inches can be mentioned.

[0107] Advantageously, the non-stick surface prevents tissue from adhering to the insert molded electrode 2540. The non-stick surface eliminates the occurrence of short circuits between opposing electrodes by setting a gap within the range of 0.002 inches to 0.004 inches along the entire length of the insert molded electrode 2540. The non-stick surface minimizes the lateral spread of RF energy by covering the sidewall 2558 of the insert molded electrode 2540. Also, the insert molded electrode 2540 exhibits structural integrity and provides an easier and more robust electrical connection than a multilayer flexible circuit.

[0108] In one aspect, the end effector comprises a conductive clamp arm and a pad structure for an ultrasonic / bipolar RF energy combined surgical device. In one aspect, the present disclosure provides a clamp arm assembly comprising a conductive or selectively conductive thin film, foil, or laminate applied around, on, or on the clamp arm assembly so as to function as a durable "pole" in a combined ultrasonic / bipolar RF energy surgical device. Further, an algorithm, software, or logic is provided to manage the conditions for the occurrence of an electrical short circuit. The electrode is adapted and configured for use with an ultrasonic / bipolar RF energy combined surgical device and is deflectable when a load is applied. This electrode is one pole of a bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0109] FIG. 33 shows an end effector 2560 comprising an ultrasonic blade 2562, a clamp arm 2564, and a clamp arm pad 2566 including a conductive film 2568, according to at least one aspect of the present disclosure.

[0110] FIG. 34 shows the clamp arm 2564 shown in FIG. 33. The clamp arm 2564 comprises a clamp jaw 2570 for supporting the clamp arm pad 2566. The thin conductive film 2568 is disposed covering the clamp arm pad 2566 to form an electrode of one of the poles of the bipolar RF circuit.

[0111] Figure 35 is a cross-sectional view of the clamp arm 2564 cut along the cut plane 35-35 of FIG. 34. The clamp jaw 2570 can be manufactured from a metal such as stainless steel. The clamp arm pad 2566 can be made of a flexible material having non-conductivity, such as PTFE, silicone, high-temperature polymer, or a similar material. The conductive film 2568 or foil can be made of a conductive material, such as any of their alloys including titanium, silver, gold, aluminum, zinc, and stainless steel.

[0112] Figure 36 shows a clamp arm 2580 with a partially conductive clamp arm pad 2582 according to at least one aspect of the present disclosure. The conductive foil 2584 covers a portion of the non-conductive pad 2586. The non-conductive pad 2588 at the proximal end 2590 sets a gap between the clamp arm pad 2582 and the ultrasonic blade.

[0113] Examples of the conductive film 2568, foil, or laminate element include a single layer of a thin conductive material, and such materials include, for example, metals (such as titanium, silver, gold, zinc, aluminum, magnesium, iron, etc., and their alloys, or stainless steel), plated metals (such as nickel plated on copper and then gold plated), or polymers filled with a high concentration of a conductive material or filler such as metal powder. Preferably, the above element is a biocompatible metal foil such as titanium, silver, gold, zinc, or stainless steel selected from a thickness in the range of 0.001 inches to 0.008 inches (0.025 mm to 0.20 mm).

[0114] The film 2568, foil, or laminate may include a thin polymer coating, film, or layer covering the thin conductive material. This coating, film, or layer has a high electrical resistance, that is, it is not a conductor that effectively conducts bipolar RF energy to adjacent tissues. The coating can be perforated to enable energy delivery from the electrode to the tissue.

[0115] The conductive material may be perforated or contain holes or windows through the entire thickness of the conductive material, which may minimize the thermal capacitance of this layer (testing has shown that longer and / or thicker foils result in longer times for tissue to be cut due to thermal energy being removed from the treatment site). These perforations, holes, or windows may also allow for retention of the foil to other parts or layers. These perforations, holes, or windows may be patterned throughout the sheet of foil, localized at the treatment site, or localized away from the treatment site, for example, only on the sides of the clamping arms.

[0116] When thin polymer coatings, films, or layers are present, they may be perforated or contain holes or windows through their entire thickness so that the conductive film, foil, or laminate is in direct communication with the tissue to deliver bipolar radiofrequency energy to the tissue. In the case of coatings, these holes or windows may be formed by selective coating or coating removal.

[0117] 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 therefore allows for a simple construction because the path is made from the necessary structural components: the support tube or actuator, which connects directly to the clamp arm, and then the conductive film, foil, or laminate.

[0118] In one aspect, the conductive film 2568, foil, or laminate is backed by a relatively soft, high-temperature, low-wear polymer or elastomeric pad made from materials such as PTFE, silicone, polyimide, high-temperature thermoplastics, among other materials. The flexibility of this relatively soft pad allows for a wide tolerance of components to obtain a zero or near-zero gap over the entire length that acts on the tissue between the jaws when the jaws are fully closed. Thus, it becomes possible to seal and cut the tissue along this length. The above flexibility also eliminates or significantly attenuates any audible vibrations of the conductive layer that may occur when the ultrasonic blade is closed against the conductive layer.

[0119] The conductive film 2568, foil, or laminate may include a rigid to semi-rigid polymer on its back side / rear surface (i.e., the surface far from the tissue and facing the clamp arm). This portion is made from an injection-moldable polymer or polymer alloy and is adhered to the film, foil, or laminate by film insert molding (FIM) or in-mold labeling (IML).

[0120] In tests, thin stainless steel, copper, or aluminum foils are quiet during surgery (do not make a "sharp, high-pitched sound" and do not make a dull, rasping sound). The thin stainless steel, copper, or aluminum foils provide a robust surface against which the ultrasonic blade can act. Since the foil is sufficiently robust, materials such as silicone rubber, which would be torn and function only as a poor pad material without the above foil, can be used and are not easily torn or cracked.

[0121] The proximal portion of the clamp surface of the jaws may not include the conductive film, foil, or laminate because this region of the jaws first contacts the blade and is more likely to cause short-circuit formation / short-circuit of the power in this region.

[0122] In one aspect, the present disclosure provides a short circuit mitigation algorithm for activating an output that includes bipolar RF energy.

[0123] If a short circuit occurs after the energy delivered for activation exceeds a threshold amount (which results in tissue thinning but indicates that the tissue likely received an adequate dose of bipolar RF energy to seal and coagulate the tissue), or after the activation time threshold is exceeded (individually again indicating that the tissue has thinned but is likely accepted and received an adequate dose), or after both the energy threshold and activation time threshold are exceeded, no short circuit alert will be issued to the user.

[0124] The process for fabricating a film on stainless steel insert molded electrode assembly involves etching the film to form openings (micro-holes, slots, or honeycomb) for RF energy passage, cutting around the electrode components, forming or adhesively bonding the film onto the stainless steel electrode as needed, placing the attached film and electrode into a polymer injection molding tool, and molding the polymer onto the back of the electrode and film.

[0125] In various aspects, the present disclosure provides combined ultrasonic / bipolar RF energy surgical devices configured to control tissue effect, charring, and / or tissue adhesion to the clamp arm, ultrasonic blade, or electrodes. In one aspect, the clamp arm jaws are configured with features or aspects to minimize tissue adhesion to the end effector components and improve tissue control. In one aspect, a tissue path or clamping area control feature is provided to adjust the tissue path relative to the clamp arm / ultrasonic blade to create a predetermined contact location, reducing tissue adhesion to the clamp arm or ultrasonic blade and tissue charring due to excessive or prolonged application of heat.

[0126] In one aspect, the end effector includes side guards to prevent tissue from accumulating on components of the end effector. In one aspect, the end effector includes a tissue path or a clamp arm area control feature to adjust the tissue path to the clamp arm / blade to create a predetermined contact location. The control feature is configured to reduce, for example, the adhesion and carbonization of tissue to end effector elements such as clamp arms. Clamp jaws, clamp arm pads, or ultrasonic blades.

[0127] In one aspect, the present disclosure provides a clamp arm having a raised sidewall or guard for surrounding an electrode to prevent exposure and prevent tissue from entering an area inside the sidewall. In one implementation, the sidewall of the clamp arm can be extruded outside and around the clamp arm pad but is not sufficient for the tissue to begin to fold. The electrode is adapted and configured for use with an ultrasonic / bipolar RF energy combined surgical device and is deflectable when a load is applied. This electrode is one pole of a bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0128] FIG. 37 shows a clamp arm 2620 including a clamp jaw 2622 and a clamp arm pad 2624 with exposed teeth 2626, according to at least one aspect of the present disclosure. The exposed teeth 2626 prevent tissue from entering an area inside the exposed teeth 2626.

[0129] FIG. 38 shows a clamp arm 2630 including a clamp jaw 2632 including a raised sidewall 2634 and a raised lip 2636, and a clamp arm pad 2638 with a plurality of teeth 2639, according to at least one aspect of the present disclosure. The raised sidewall 2634 and the raised lip 2636 prevent tissue from accumulating inside 2637 of the sidewall 2634 and the raised lip 2636.

[0130] In one aspect, the present disclosure provides an end effector comprising an electrode having a surrounding wall and a silicone seal located on a clamp arm. FIGS. 39-41 illustrate an electrode with a surrounding wall. FIG. 39 shows a clamp arm 2640 comprising an electrode 2642 having a surrounding wall 2644 supported by a clamp jaw 2646, and a clamp arm pad 2647. FIG. 40 is a cross-sectional view of the clamp jaw 2640 cut along the cut plane 173-173 of FIG. 39. Since it is desirable to prevent or minimize tissue penetration and tissue accumulation / adhesion between the electrode 2642 and the clamp jaw 2644, in one aspect, the surrounding wall 2644 around the electrode 2642 is sized and configured to prevent tissue from entering and accumulating in the space 2643 defined between the electrode 2642, the clamp jaw 2646, and the clamp arm pad 2647 below the electrode 2642. The electrode 2642 is adapted and configured for use with an ultrasonic / bipolar RF energy composite surgical device and is deflectable when loaded. This electrode 2642 is one pole of a bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0131] FIG. 41 illustrates alternative or additional features of the electrode with a surrounding wall shown in FIGS. 39-40. In the aspect shown in FIG. 141, in at least one aspect of the present disclosure, a sealant 2648, such as silicone or other fluid polymer, may be provided in the space 2645 below the electrode 2642 and above the clamp jaw 2646 to prevent tissue from entering and accumulating under the electrode 2642.

[0132] In one aspect, the present disclosure provides an end effector comprising a skirt portion for a deflectable / cantilever electrode. It is common for tissue to adhere to the RF electrode and for fluid to accumulate between the electrode and the clamp jaw after being heated by an RF-based energy surgical device. Thus, it would be desirable to reduce the accumulation of tissue / fluid between the electrode and the clamp arm or to prevent the tissue from being clamped. In one aspect, FIGS. 42-44 of the present disclosure show electrodes that prevent or minimize the accumulation of tissue and fluid between the electrode and the clamp arm, thereby restricting the deflection function of the electrode or preventing the electrode from returning to its neutral position when not clamped. The electrode is fixed at its proximal end to the clamp jaw and deflects freely at its distal end. Thus, throughout the present disclosure, the electrode may be referred to as a cantilever beam electrode or a deflectable electrode. The electrode is adapted and configured for use with an ultrasonic / bipolar RF energy composite surgical device and is deflectable under load. This electrode is one pole of a bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0133] By configuring the skirt portions to overlap, the stiffness of the deflectable electrode is increased. Upon deflection, the skirt portions are displaced outwardly to remove / discharge tissue around the clamp arm.

[0134] FIG. 42 shows a clamp arm 2650 comprising a clamp jaw 2652, an electrode 2654, a clamp arm pad 2656 having a plurality of teeth 2657 (FIG. 43), and a deflectable ledge 2658 along the lateral side of the electrode 2654, according to at least one aspect of the present disclosure. FIGS. 43-44 are cross-sectional views of the clamp arm 2650 shown in FIG. 42, cut along the incision plane 176-176. FIG. 43 shows the electrode 2654 and the skirt portion 2658 in an undeflected state, and FIG. 44 shows the electrode 2654 and the skirt portion 2658 in a deflected state, where the skirt portion 2658 is laterally shifted in the direction indicated by the arrow 2659.

[0135] 42-43 , a clamp arm 2650 is configured for use with an end effector comprising an ultrasonic blade for use in a combined ultrasonic / bipolar RF energy device. The proximal end 2660 of the electrode 2654 is attached to the clamp jaw 2652 by any suitable fastener 2653 or any suitable fastening technique, such as welding, laser welding, brazing, soldering, or stamping, among other fastening techniques. The distal end 2662 of the electrode 2654 is free to move, as in a cantilever. As previously mentioned, the clamp arm pad 2656 is made of a flexible material such as Teflon (PTFE), although similar polymers could alternatively be used. The electrode 2654 is fixed to the clamp jaw 2652 at its proximal end and is free to deflect at its distal end. Thus, throughout this disclosure, the electrode 2654 may be referred to as a cantilever beam electrode or a deflectable electrode.

[0136] The deflectable ledge is disposed between the electrode 2654 and the clamp jaw 2652 and includes an elastomeric skirt 2658 overmolded onto a lower periphery of the electrode 2654 to overlap the electrode 2654. The overmolded skirt 2658 prevents tissue and fluid from accumulating or becoming trapped between the electrode 2654 and the clamp jaw 2652 when they are in a deflected state. The configuration in which the overmolded skirt 2658 overlaps the clamp jaw 2652 can also reinforce the electrode 2654 if needed for a particular implementation. When the electrode 2654 is deflected toward the clamp jaw 2652, the overmolded skirt 2658 displaces outward to remove and expel tissue from around the clamp arm 2658, the electrode 2654, or the clamp jaw 2652.

[0137] In one aspect, the present disclosure provides an end effector comprising an electrode curtain. It is often seen that the tissue adheres between the clamp jaw and the RF electrode after being heated by an RF energy surgical device. Thus, as described above, in an ultrasonic / bipolar RF energy combined surgical device, it would be desirable to reduce the accumulation of tissue between the electrode and the clamp arm. Thus, as shown in FIGS. 45-47 of the present disclosure, various clamp arms are configured to reduce tissue accumulation and attachment points. In one aspect, the clamp arm comprises an electrode that extends downward along the side surface of the clamp arm like a curtain to reduce the gap where the tissue may enter and accumulate during RF sealing. The electrode is adapted and configured for use with an ultrasonic / bipolar RF energy combined surgical device and is deflectable when a load is applied. This electrode is one pole of a bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0138] FIG. 45 shows a clamp arm 2670 including a clamp jaw 2672, an electrode 2674, a sidewall 2676 extending downwardly from the electrode 2674 beyond a sidewall 2678 of the clamp jaw 2672, and a clamp arm pad 2677 ( FIG. 46 ) including a plurality of teeth 2679, in accordance with at least one embodiment of the present disclosure. FIG. 46 is a cross-sectional view of the clamp arm 2670 shown in FIG. 45 taken along section line 46-46. Referring to FIGS. 45-46 , the clamp arm 2670 is configured for use with an end effector including an ultrasonic blade for use in a combined ultrasonic / bipolar RF energy surgical device. The sidewalls 2676 of the electrode 2674 cover the sides of the clamp jaw 2672 and extend around the distal end 2684 of the clamp jaw 2672 to close the gap and prevent tissue buildup in the space 2680 defined between the electrode 2674 and the clamp jaw 2672. Arrow 2682 indicates the deflection path of the electrode 2674. As previously described, the clamp arm pad 2686 is made of a flexible material such as PTFE or a similar polymeric material. The electrode 2674 is attached to the proximal end 2688 of the clamp jaw 2672 by any suitable fastener 2673 or any suitable fastening technique such as, for example, welding, laser welding, brazing, soldering, stamping, among other fastening techniques. The electrode 2674 is fixed to the clamp jaw 2672 at its proximal end and is free to deflect at its distal end. Thus, throughout this disclosure, electrode 2674 may be referred to as a cantilever beam electrode, or a deflectable electrode.

[0139] FIG. 47 shows an alternative clamp arm 2690 to the clamp arm 2670 shown in FIGS. 45 - 46, according to at least one aspect of the present disclosure. The clamp arm 2690 includes a clamp jaw 2692, an electrode 2694 having a side wall 2696 that extends downwardly from the electrode 2694 beyond the side wall 2698 of the clamp jaw 2692, and a clamp arm pad 2697. The side wall 2698 prevents tissue from accumulating within the space 2691 defined between the electrode 2694 and the clamp jaw 2692. The clamp arm 2690 further includes a deflection stop surface 2700 that is remote from the interface with the tissue. The electrode 2694 is fixed to the clamp jaw 2692 at its proximal end and deflects freely at its distal end. Thus, throughout the present disclosure, the electrode 2694 may be referred to as a cantilever beam electrode or a deflectable electrode.

[0140] In one aspect, the present disclosure provides an end effector comprising a deflectable / cantilever electrode with a shield lip to prevent tissue accumulation within the end effector or its components. It is often seen that tissue adheres between the clamp jaw and the RF electrode after heating with an RF energy surgical device. Thus, as described above, it would be desirable to prevent or minimize tissue accumulation between the electrode and the clamp jaw. FIG. 48 is a perspective top view of an electrode 2710 having a lip 2712 that extends downwardly from the top surface 2714 of the electrode 2710, according to at least one aspect of the present disclosure. FIG. 49 is a bottom perspective view of the electrode 2710 shown in FIG. 48, showing the downwardly extending lip 2712. FIGS. 50 - 51 are perspective top views of the electrode 2710 shown in FIGS. 48 - 49, shown with a clamp arm pad 2718 having teeth 2719 that extend through an opening 2716.

[0141] 48-51 , the electrode 2710 defines an opening 2716 for receiving an element of a clamp arm pad therethrough. The electrode 2710 is configured for use with an end effector comprising an ultrasonic blade for use in a combined ultrasonic / bipolar RF energy device. The electrode 2710 is secured to the clamp jaws at its proximal end and is free to deflect at its distal end. Thus, throughout this disclosure, the electrode 2710 may be referred to as a cantilever beam electrode, or a deflectable electrode.

[0142] 48-51, the electrode 2710 exhibits a shielding lip 2712 to prevent tissue buildup within the space defined between the electrode 2710 and the clamp jaw. The lip 2712 surrounds the clamp arm and electrode 2710 to prevent tissue from entering the space between the electrode 2710 and the clamp jaw. An insulating coating may be added to the lip 2712 to prevent any electrode activity from emanating from the lip 2712. The electrode 2710 is secured to the clamp jaw at its proximal end and is free to deflect at its distal end. Thus, throughout this disclosure, the electrode may be referred to as a cantilever beam electrode or a deflectable electrode. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load. The electrode is one pole of a bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0143] In one aspect, the present disclosure provides an end effector including a deflectable / cantilever electrode with a compression block and a separate clamp arm pad unit. In one aspect, the deflectable / cantilever electrode with a compression block and a separate clamp arm pad unit is configured to reduce the trade-off decision between an ultrasonic device with precise cutting capabilities and a bipolar RF device with more reliable sealing capabilities. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load. The electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0144] In one aspect, the end effector utilizes individual clamp arm pads with collar features to prevent electrode delamination when the jaws are open, and the end effector utilizes a pre-compressed block to prevent tissue fragments from entering the side gap between the electrode and clamp jaws, reducing the risk of sticking.

[0145] In one aspect, the end effector architecture includes an end effector clamp arm side having a plurality of individual clamp arm pad units, each having a collar feature that constrains the electrode from peeling and increases the volume of the pad relative to the ultrasonic blade tip when the jaws are open, and each having a foot / tip feature that aligns with and is constrained by a slot feature on the clamp arm.

[0146] In another aspect, the end effector includes an electrode with a pad slot feature oriented in a particular direction that allows for assembly of the electrode and helps hold the clamp arm pad in place.

[0147] In yet another aspect, the end effector includes a compression block between the electrode and the clamp jaws that prevents tissue fragments from getting into the side gaps, reduces the risk of jamming, helps hold the parts together, and ensures there is no gap between the pad collar and the electrode before clamping the tissue.

[0148] FIG. 52 shows an end effector 2720 comprising a clamp arm 2722 and an ultrasonic blade 2724, according to at least one aspect of the present disclosure. Referring also to FIGS. 53-54, the clamp arm 2722 includes a clamp jaw 2726, an electrode 2728 defining a plurality of apertures 2730 sized and configured to receive a plurality of individual tissue pad units 2732, a single-piece elastic / superelastic block 2734, a small wear-resistant gap pad 2736, and a large wear-resistant gap pad 2738. The single-piece elastic / superelastic block 2734 is made of an elastic or superelastic material such as, for example, polythylene, rubber, or sponge, to provide spring-like characteristics. The electrode 2728 functions as one pole of a bipolar RF circuit, and the ultrasonic blade 2724 functions as the opposite pole of the bipolar RF circuit. The electrode 2728 is fixed to the clamp jaw 2726 at its proximal end and deflects freely at its distal end. Thus, throughout the present disclosure, the electrode 2728 may be referred to as a cantilever beam electrode, or a deflectable electrode.

[0149] FIG. 55 is various views of an individual tissue pad unit 2732, according to at least one aspect of the present disclosure. The tissue pad unit 2732 includes a pad collar 2742, a pad neck 2746, a pad foot 2748, and a pad tip 2750. When the tissue is clamped, the tissue pushes the electrode 2728 into a deflected state, and at the same time, the electrode 2728 pushes the slightly compressed elastic block 2734 into a more compressed state. When the tissue is completely severed, the more compressed block 2734 pushes the electrode 2728 back against the tissue pad collar 2740, but the block 2734 remains slightly compressed to maintain a zero gap between the tissue pad unit 2732 and the electrode 2728. When the clamp jaw 2726 is open, the tissue pad collar 2740 prevents the electrode 2728 from peeling off.

[0150] FIG. 56 shows an electrode 2728 according to at least one aspect of the present disclosure. The electrode 2728 defines a plurality of openings 2730. The plurality of openings 2730 have a shape similar to the pad foot 2748 shown in FIG. 55 and function as pad slots on the electrode 2728. The electrode 2728 also defines two slots 2752, one for receiving a small wear-resistant gap pad 2736 and the other, another slot 2754, for receiving a large wear-resistant gap pad 2738.

[0151] FIG. 57 shows a cross-sectional view of a clamp arm 2722 showing an elastic / superelastic block 2734 according to at least one aspect of the present disclosure. In one aspect, the elastic / superelastic block 2734 functions as a pre-compressed block 2734 to press the electrode 2728 against the tissue pad collar 2740 and hold the components together, at the contact region (shown by arrow 2756), to press the clamp arm 2722 against the pad foot 2748 and ensure that there is no gap between the pad collar 2742 and the electrode 2728 before clamping the tissue.

[0152] FIG. 58 is a perspective view of the elastic / superelastic block 2734. FIGS. 59 and 61 are perspective views of a subassembly 2760 comprising a clamp jaw 2726, an electrode 2728, and an individual tissue pad unit 2732 according to at least one aspect of the present disclosure. This figure shows a side gap 2758 formed between the electrode 2728 and the clamp jaw 2726. FIG. 60 is a perspective view of an assembly of a clamp arm 2722 comprising the elastic / superelastic block 2734 of FIG. 58 assembled to the subassembly 2760. Referring now to FIGS. 58 - 61, the pre-compressed block 2734 prevents tissue fragments from entering the side gap 2758 between the electrode 2728 and the clamp jaw 2726, reducing the risk of adhesion.

[0153] 62 shows a first assembly step according to at least one embodiment of the present disclosure, in which an individual tissue pad unit 2732 is inserted into the electrode 2728. The tissue pad foot 2748 is aligned with the electrode pad slot 2730, and the tissue pad unit 2732 is inserted into the electrode pad slot 2730 until the tissue pad collar 2742 abuts the electrode 2728.

[0154] 63-65 illustrate a second assembly step according to at least one embodiment of the present disclosure. In this step, the individual tissue pad unit 2732 is locked into the electrode 2728. The tissue pad unit 2732 is rotated counterclockwise through an angle of 35° (see also FIG. 56 ); in this “locked” position, the functional pairing of the pad foot 2748 and pad collar 2742 prevents the tissue pad unit 2732 from falling off the electrode 2728. Also in this position, the pad tip 2750 is roughly aligned for assembly into the clamp arm 2722. This creates a first subassembly 2762.

[0155] 66 illustrates a third assembly step, according to at least one embodiment of the present disclosure, in which a single-piece elastic / superelastic block 2734 is coupled to clamp jaws 2726. This creates a second subassembly 2764.

[0156] Figures 67-72 illustrate a fourth assembly step according to at least one aspect of the present disclosure. In this step, a first sub-assembly 2762 manufactured in the second assembly step described in FIGS. 63-65 is assembled with a second sub-assembly 2764 manufactured in the third assembly step, as described in the step of FIG. 66, to manufacture a clamp arm 2722. The pad tip 2750 is roughly aligned with the clamp arm slot 2766. Then, the first sub-assembly 2762 is inserted into the second sub-assembly 2764. The clamp arm slot 2766 functional portion functions to assist in aligning the pad tip 2750 and functions to restrict the rotational freedom of the tissue pad unit 2732 along the pad shaft direction indicated by the arrow 2768. Next, the three translational degrees of freedom and three rotational degrees of freedom of the tissue pad unit 2732 are completely restricted by the electrodes 2728 and the clamp arm 2722. The electrode 2728 is coupled to the clamp arm 2722 at the coupling point 2770. After assembly, the single-piece elastic / superelastic block 2734 is pre-compressed. The clamp arm functional portion 2772 prevents the tissue pad unit 2732 from exiting in the direction indicated by the arrow 2774.

[0157] Figures 73-74 illustrate a fifth assembly step according to at least one aspect of the present disclosure. In this step, two small wear-resistant gap pads 2736 are press-fitted into the slot 2752 defined by the electrode 2728, and a large wear-resistant gap pad 2738 is slid into the slot 2754 defined by the electrode 2728.

[0158] In one aspect, the present disclosure provides an end effector having a filled gap between the electrode and the clamp arm. It is common for tissue to stick between the clamp jaw and the RF electrode after heating with RF-based energy surgical devices. Therefore, as previously discussed, it may be desirable to prevent or minimize tissue from adhering within the clamp arm between the clamp jaw and the electrode. Accordingly, FIG. 75 illustrates a clamp arm 2780 including a filler material 2782 filled between the electrode 2784 and the clamp jaw 2786, according to at least one aspect of the present disclosure. The filler material 2782 may be a woven nylon fabric or a 3D-printed structure. The filler material 2782 prevents tissue from entering the space 2788 between the electrode 2784 and the clamp jaw 2786. The 3D-printed structure may be printed with a specific shape to maximize compression. The electrode 2784 is fixed to the clamp jaw 2786 at its proximal end and is free to deflect at its distal end. Thus, throughout this disclosure, electrode 2784 may be referred to as a cantilever beam electrode or a deflectable electrode. Electrode 2784 is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load. This electrode 2784 is one pole of a bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0159] In one aspect, the present disclosure provides an end effector with a deflectable / cantilever electrode. It would be desirable to improve the ease of manufacturing the electrode and reduce tissue buildup between the electrode and the clamp jaws. It is further desirable to prevent or minimize tissue from adhering to the electrode. FIGS. 76-78 illustrate various devices for addressing these desired improvements, according to at least one aspect of the present disclosure. The electrode is secured to the clamp jaws at its proximal end and is free to deflect at its distal end. Thus, throughout this disclosure, the electrode may be referred to as a cantilever beam electrode or a deflectable electrode. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load. The electrode is one pole of a bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0160] In the embodiment shown in FIG. 76, the clamp arm 2790 is easy to manufacture by eliminating a separate clamp arm electrode, constructing the surface 2792 of the clamp arm, and eliminating a separate electrode blade. Here, the clamp arm serves as the electrode. Also, a polyimide (Vespel) clamp arm pad 2794 is overmolded onto the clamp jaw 2796.

[0161] In the embodiment shown in FIG. 77, the clamp arm 2800 prevents tissue from accumulating between the electrode 2802 and the clamp jaw 2804 by adding a skirt portion 2806 around the electrode 2802 or, alternatively, by adding a skirt portion 2806 around the clamp jaw 2804. Thereby, not only can the electrode 2802 still deflect, but it can also prevent tissue accumulation. The electrode 2802 is fixed to the clamp jaw 2804 at the proximal end and deflects freely at the distal end. Thus, throughout the present disclosure, the electrode 2802 may be referred to as a cantilever beam electrode or a deflectable electrode.

[0162] In the embodiment shown in FIG. 78, a cross-sectional view of an end effector 2810 is shown, which includes an ultrasonic blade 2812 and a clamp arm 2814 configured to improve tissue grasping on the distal side. The clamp arm 2814 defines a curved portion 2816 at the distal end of a polyimide gap arm pad and / or at the distal end of the teeth of a clamp arm pad (PTFE).

[0163] In one aspect, the present disclosure provides an end effector configured to minimize tissue adhesion via the geometric shape of the electrodes and the clamp arm bumper / bulb elements. It is often seen that tissue adheres to the RF electrodes after being heated by an RF-based energy surgical device. Therefore, as described above, it would be desirable to minimize or prevent tissue adhesion to the RF electrodes. This is achieved by the new geometry of the electrodes and also by adding the clamp arm bumper / bulb nose to the clamp jaw, which can minimize electrode detachment. FIG. 79 shows a clamp arm 2820 comprising a clamp jaw 2822, an electrode 2824, a clamp arm pad 2826 having a plurality of teeth 2836, a curtain 2828 located on each side of the electrode 2824 to minimize the tissue clamping point, and a bulb nose / clamp arm bumper 2830 to minimize electrode detachment by first contacting the tissue while making an incision with a dull blade. The clamp arm 2820 further comprises a rigid gap setting pad 2832 at the proximal end 2834 of the clamp arm 2820. The clamp arm pad 2826 is made of a flexible polymer such as Teflon (PTFE), and the rigid gap setting pad 2832 is made of a rigid polyimide material. The electrode 2824 is fixed to the clamp jaw 2822 at the proximal end and deflects freely at the distal end. Thus, throughout the present disclosure, the electrode 2824 may be referred to as a cantilever beam electrode or a deflectable electrode. The electrode 2824 is adapted and configured for use with an ultrasonic / bipolar RF energy combined surgical device and is deflectable under load. This electrode 2824 is one pole of a bipolar RF circuit, and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0164] 80-81 illustrate an alternative clamp arm 2840 including a clamp jaw 2842, an electrode 2844, a clamp arm pad 2846 including a plurality of teeth 2854, and curtains 2848 positioned on either side of the clamp arm pad 2846, in accordance with at least one embodiment of the present disclosure. FIG. 80 shows an assembled view of the clamp arm 2840, FIG. 81 shows an exploded view of the clamp arm 2840, and FIG. 82 shows a cross-sectional view of the clamp arm 2840 taken along section plane 81-81. The curtains 2848 prevent tissue from being pinched and improve manufacturability of the clamp arm 2840. A proximal end 2850 of the clamp arm 2840 includes a rigid gap setting pad 2852. The electrode 2844 includes a plurality of openings 2854 for receiving the plurality of clamp arm pad 2846 teeth. The clamp arm pad 2846 is made of a flexible polymer such as Teflon (PTFE), and the hard gap setting pad 2852 is made of a hard polyimide material. The electrode 2844 is fixed to the clamp jaw 2842 at its proximal end and is free to deflect at its distal end. Thus, throughout this disclosure, the electrode 2844 may be referred to as a cantilever beam electrode, or a deflectable electrode.

[0165] In one aspect, the present disclosure provides an end effector with a deflectable electrode including anti-tissue adhesion features. It is common for tissue to adhere to the RF electrode after heating with RF-based energy surgical devices. The tissue typically separates and flows into the space around the electrode, then resolidifies, forming anchor points that become larger tissue masses. To ensure tissue adhesion is eliminated, the formation of anchored tissue must be prevented or removed after formation. FIGS. 82-85 show a clamp arm 2860 including a clamp jaw 2862, a cantilever electrode 2864, a clamp arm pad 2866 including teeth 2868 received through an opening 2870 defined by the cantilever electrode 2864, and rigid gap setting pads 2872, 2874, in accordance with at least one embodiment of the present disclosure. The electrode 2864 is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load. This electrode 2864 is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0166] FIG. 82 is a side view and FIG. 84 is a bottom perspective view of a clamp arm 2860, according to at least one embodiment of the present disclosure. Both figures show the cantilever electrode 2864 in an undeflected state. FIG. 83 is a side view and FIG. 85 is a bottom perspective view of a clamp arm 2860 with the cantilever electrode 2864 in a deflected state to pull tissue from the teeth 2868 of the clamp arm pad 2866, according to at least one embodiment of the present disclosure.

[0167] Referring now to FIGS. 82-84, in one method, the cantilever electrode 2864 passes through the end of the pad tooth 2868 to pull the tissue out of the anchor spot before the tissue cools. The cantilever electrode 2864 can move by a spring force independently of the clamp jaw 2862 and the clamp arm pad 2866. The opening 2870 of the cantilever electrode 2864 for the clamp arm pad 2866 can move away from the clamp arm pad 2866 to ensure that there is no anchor after sealing.

[0168] In various aspects, the present disclosure provides ultrasonic / bipolar RF energy composite surgical devices and systems. Various forms are directed to user interfaces for surgical instruments comprising ultrasonic and / or electrosurgical (RF) end effectors configured to effect treatment, incision, cutting, and / or coagulation of tissue during a surgical procedure. In one form, a user interface for a composite ultrasonic and electrosurgical instrument is provided, the instrument being configured for use in open surgery, but also having applications in other types of surgery, such as minimally invasive laparoscopy or non-invasive endoscopy, either in a hand-held or robot-assisted surgery. Versatility is achieved by selectively applying a number of energy modalities simultaneously, independently, sequentially, or in combinations thereof. For example, versatility can be achieved by selectively using ultrasonic and electrosurgical energy (e.g., monopolar or bipolar RF energy) in any of a simultaneous, independent, sequential, or combined manner.

[0169] In one aspect, the present disclosure provides a user interface for a device including an ultrasonic blade and a clamp arm including a deflectable RF electrode, which cooperate to seal, cut, and clamp tissue by cooperation of a clamping mechanism of the device including the RF electrode and an associated ultrasonic blade. The clamping mechanism includes a pivoting clamp arm that cooperates with the ultrasonic blade to grasp tissue therebetween. The clamp arm is preferably provided with a clamp tissue pad (also known as a "clamp arm pad") having a plurality of axially spaced apart grasping teeth, segments, elements, or individual units that facilitate grasping and gripping of tissue during surgery while cooperating with the ultrasonic blade of the end effector to achieve the desired sealing and cutting effect on the tissue.

[0170] In one aspect, the end effectors described herein comprise electrodes. In other aspects, the end effectors described herein comprise alternatives to the electrodes described above, which provide conformal RF energy coupling to tissue, accommodate pad wear / thinning, minimize excessive heat generation (low coefficient of friction, pressure), minimize spark generation, minimize interruptions due to electrical shorts, or a combination thereof. The electrodes are fixed at their proximal ends to the clamp jaws and are free to deflect at their distal ends. Thus, throughout this disclosure, the electrodes may be referred to as cantilever beam electrodes or deflectable electrodes.

[0171] In other aspects, the end effectors described herein comprise a clamp arm mechanism configured to apply high pressure between the pad and ultrasonic blade to grasp and seal tissue, maximizing the likelihood of tissue contact in constrained or difficult scenarios, such as thin tissue, tissue under lateral tension, tissue under lifted / vertical tension, and especially tissue that is lifted away from the clamp arm.

[0172] In other aspects, the end effectors described herein are configured to balance the surface area / current density harmony between electrodes and minimize the heat conduction balance from the interface with the tissue, for example, affecting the formation and symmetry of the denatured part, and also affecting the cycle time, residual heat energy, etc. In other aspects, the end effectors described herein are configured to minimize adhesion and tissue attachment (minimize anchor points) and may include small polyimide pads.

[0173] In various aspects, the present disclosure provides a surgical device configured to deliver at least two energy types (e.g., ultrasound, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue. The surgical device includes a first activation button switch for activating the energy and a second button switch for selecting the energy mode of the activation button switch. The second button switch is connected to a circuit that defines the energy mode using at least one input parameter. The input parameter can be remotely modified via a connection to the generator or a software update.

[0174] In one aspect, at least one of the energy modes is a simultaneous blend of RF energy and ultrasound energy, and the input parameter represents the duty cycles of the RF energy and the ultrasound energy.

[0175] In one aspect, the second button switch is configurable to select from a list of predetermined modes, and the number of modes in the list is defined by a second input parameter defined by the user.

[0176] In one aspect, the input parameter is any one of a duty cycle, voltage, frequency, pulse width, or current.

[0177] In one aspect, the device also includes a visual indicator of the selected energy mode within a portion of the device within the surgical field.

[0178] In one aspect, the second button switch is a separate control from the end effector closure trigger.

[0179] In one embodiment, the second button switch is configured to be actuated by a second stage of the closure trigger. A first stage of the closure trigger in the closing direction is to actuate the end effector.

[0180] In one aspect, at least one of the energy modes is selected from ultrasound, RF bipolar, RF monopolar, microwave, or IRE.

[0181] In one aspect, at least one of the energy modes is selected from ultrasound, RF bipolar, RF monopolar, microwave, or IRE and is configured to be applied with a predetermined duty cycle or pulse algorithm.

[0182] In one embodiment, at least one of the energy modes is selected from the sequential application of two or more of the following energy types: ultrasound, RF bipolar, RF monopolar, microwave, or IRE.

[0183] In one embodiment, at least one of the energy modes is a simultaneous blend of two or more of the following energy types: ultrasound, RF bipolar, RF monopolar, microwave, and IRE.

[0184] In one embodiment, at least one of the energy modes is a simultaneous blend of two or more of the following energy types: ultrasound, RF bipolar, RF monopolar, microwave, and IRE, followed by one or more of the aforementioned energy types.

[0185] In one embodiment, at least one of the energy modes is one of the following energy types: ultrasound, RF bipolar, RF monopolar, microwave, and IRE, followed by a simultaneous blend of two or more of the foregoing energy types.

[0186] In one aspect, at least one of the energy modes is a predetermined algorithm that is surgery-specific or tissue-specific.

[0187] In one aspect, at least one of the energy modes is compiled from learned surgical acts or activities.

[0188] In one aspect, the input parameter is at least one of energy type, duty cycle, voltage, frequency, pulse width, current, impedance limit, activation time, or blend of energy.

[0189] In one aspect, the second button switch is configurable to select from a list of predetermined modes, where the number of modes in the list is either predefined or defined by a second input parameter defined by the user.

[0190] In one aspect, the aforementioned energy modes become available to the user through a software update to the generator.

[0191] In one aspect, the aforementioned energy modes become available to the user through a software update to the device.

[0192] In one aspect, the user's preferred selections become available to multiple generators through either networking, cloud, or manual transfer.

[0193] In one aspect, the device also includes a visual indicator of the selected energy mode within the portion of the device within the surgical field.

[0194] As used herein, a button switch can be an electromechanical device that is manually, mechanically, or electrically operated and includes one or more sets of electrical contacts that are connected to an external circuit. Each set of electrical contacts can be in one of two states, where the "closed" state means that the contacts are touching and electricity can flow between them, and the "open" state means that the contacts are separated and the switch is not conducting electricity. The mechanism that actuates the transition between these two states (open or closed) can be of the "alternating action" type (where flipping the switch results in continuous "on" or "off") or the "momentary" type (where pressing it turns it "on" and releasing it turns it "off").

[0195] In one aspect, the present disclosure provides an ultrasonic / bipolar RF energy composite surgical device that includes mode selection and visual feedback on the device. As surgical devices have evolved and become more capable, the number of specialized modes in which those devices can operate has increased. Adding additional button switches on the device to accommodate these new additional modes complicates the user interface and makes the device more difficult to use. Accordingly, the present disclosure provides techniques for assigning different modes to a single physical button switch, which enables selection of modes from a wider range without adding complexity to the housing design (e.g., by adding ever more button switches). In one aspect, the housing is in the form of a handle or a pistol grip.

[0196] As more specialized modes become available, there is a need to provide a surgeon using a surgical device with many modes without creating a complex user interface. The surgeon desires to be able to control mode selection from within the sterile field rather than relying on a circulating nurse located at the generator. The surgeon desires real-time feedback so that they can be confident in knowing which mode is selected.

[0197] FIG. 86 shows a device 100 with a mode selection button switch 130 on a surgical device 100 according to at least one aspect of the present disclosure. The surgical device 100 includes a housing 102 that defines a handle 104 in the form of a pistol grip. The housing 102 includes a trigger 106, and when the trigger 106 is squeezed, the trigger 106 is received within an internal space defined by the handle 104. The trigger 106 is used to operate a clamp arm 111 portion of an end effector 110. The clamp jaw 112 is pivotably movable about a pivot point 114. The housing 102 is coupled to the end effector 110 via a shaft 108 that is rotatable by a knob 122.

[0198] The end effector 110 includes a clamp arm 111 and an ultrasonic blade 116. The clamp arm 111 includes a clamp jaw 112, an electrode 118, and a clamp arm pad 120. In one aspect, the clamp arm pad 120 is made of a non-stick and lubricious material such as PTFE or a synthetic fluoropolymer of similar tetrafluoroethylene. PTFE is a hydrophobic, non-wetting, high-density, high-temperature resistant, multi-purpose material with non-stick properties. The clamp arm pad 120 is non-conductive. In contrast, the electrode 118 is made of a conductive material for delivering electrical energy such as, for example, monopolar RF, bipolar RF, microwave, or irreversible electroporation (IRE). The electrode 118 can include a gap-setting pad made of a polyimide material and, in one aspect, is made of, for example, a high-durability, high-performance polyimide-based plastic known under the trade name VESPEL by DuPont, or, for example, other suitable polyimides, polyimide polymer alloys, or PET (polyethylene terephthalate), PEEK (polyetherketone), PEKK (polyetherketoneketone) polymer alloys. Unless otherwise described separately herein, the clamp arm pads and gap pads described hereinbelow are made of the materials described in this paragraph.

[0199] The electrode 118 and the ultrasonic blade 116 are coupled to a generator 133. The generator 133 is configured to drive RF, microwave, or IRE energy to the electrode 118. The generator 133 is also configured to drive an ultrasonic transducer acoustically coupled to the ultrasonic blade 116. In certain implementations, the electrode 118 is one pole of the electrical circuit, and the ultrasonic blade 116 is the opposite pole of the electrical circuit. The housing 102 includes a switch 124 for activating the ultrasonic blade 116. The circuit may be housed in the housing 102 or may be present within the generator 133. The surgical device 100 is coupled to the generator 133 via a cable 131. The cable 131 transmits signals for the electrosurgical function and the ultrasonic transducer.

[0200] In various aspects, the surgical device 100 is configured to deliver at least two energy types (e.g., ultrasonic, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue located within the end effector 110 between the clamp arm 111 and the ultrasonic blade 116. The housing 102 of the surgical device 100 includes a first activation button switch 126 for activating the energy and a second, “mode” button switch 130 for selecting the energy mode for the activation button switch. The second button switch 130 is connected to a circuit that defines the energy mode using at least one input parameter. The input parameter can be remotely modified via a connection to the generator or a software update. The energy mode is displayed on the user interface 128.

[0201] In one aspect, the surgical instrument 100 provides mode switching via a direction selector “mode” button switch 130 on the device. The user can press the mode button switch 130 to switch modes from different overall modes, and the colored light on the user interface 128 indicates the selected mode.

[0202] 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. However, each time the mode button switch 130 is pressed, or each time it is pressed and held, the surgical device 100 switches modes from among all the available modes displayed on the user interface 128. Once a certain mode is selected, the generator 133 provides an appropriate tone representing the generator, and the surgical device 100 has a lighting indicator on the user interface 128 to indicate which mode has been selected.

[0203] In the example shown in FIG. 86, the "Mode" selection button switch 130 is symmetrically disposed on both sides of the housing 102. This enables both right-handed and left-handed surgeons to select / switch a mode from among all the modes without using the non-dominant hand. In this aspect, the "Mode" selection button switch 130 can switch in many different directions, which allows the surgeon to select from a list of options remotely from the sterile field without having to ask a circulator to make adjustments at the location of the generator 133 and to navigate more complex selections. In addition to the tone representing the generator 133, the lighting indicator on the user interface 128 of the surgical device 100 provides feedback to the surgeon as to which mode is selected.

[0204] FIGS. 87A-87C show three options for selecting various operating modes of the surgical device 100 according to at least one aspect of the present disclosure. In addition to the colored light user interface 128 on the housing 102 of the surgical device 100, mode selection feedback can be heard and / or viewed through the interface of the generator 133, in which case the generator 133 verbally announces the selected mode and / or shows an explanation of the selected mode on the screen of the generator 133.

[0205] FIG. 87A shows a first mode selection option 132A in which the button switch 130 can be pushed forward 136 or backward 134 to cycle the surgical instrument 100 through various modes.

[0206] FIG. 87B shows a second mode selection option 132B in which the button switch 130 is pushed upward 140 or downward 138 to cycle the surgical instrument 100 through various modes.

[0207] FIG. 87C shows a third mode selection option 132C in which the button switch 130 is pushed forward 136, backward 134, upward 149, or downward 138 to cycle the surgical instrument 100 through various modes.

[0208] FIG. 88 illustrates a surgical device 150 including a mode selection button switch 180 on a rear surface of the device 150, according to at least one embodiment of the present disclosure. The surgical device 150 includes a housing 152 defining a handle 154 in the form of a pistol grip. The housing 152 includes a trigger 156 that, when squeezed, is received within an interior space defined by the handle 154. The trigger 156 is used to operate a clamp arm 161 portion of an end effector 160. The clamp jaw 162 is pivotally movable about a pivot point 164. The housing 152 is coupled to the end effector 160 via a shaft 158 that is rotatable by a knob 172.

[0209] 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 a similar synthetic fluoropolymer of tetrafluoroethylene. PTFE is a hydrophobic, non-wetting, high-density, high-temperature resistant, versatile material with non-stick properties. The clamp arm pad 170 is non-conductive. In contrast, the electrode 168 is made of a conductive material for delivering electrical energy such as, for example, monopolar RF, bipolar RF, microwave, or irreversible electroporation (IRE). The electrode 168 can include a gap-setting pad made of a polyimide material and, in one aspect, is made of a high-durability, high-performance polyimide-based plastic, such as that made by DuPont and known under the trade name VESPEL, or, for example, other suitable polyimides, polyimide polymer alloys, or PET (polyethylene terephthalate), PEEK (polyetheretherketone), PEKK (polyetherketoneketone) polymer alloys, unless otherwise described separately herein. The clamp arm pads and gap pads described hereinbelow are made of the materials described in this paragraph, unless otherwise noted.

[0210] The electrode 168 and the ultrasonic blade 166 are coupled to a generator 133. The generator 133 is configured to drive RF, microwave, or IRE energy to the electrode 168. The generator 133 is also configured to drive an ultrasonic transducer acoustically coupled to the ultrasonic blade 166. In certain implementations, the electrode 168 is one pole of an electrical circuit and the ultrasonic blade 166 is the opposite pole of the electrical circuit. The housing 152 includes a switch 174 for activating the ultrasonic blade 166. The circuit can be housed within the housing 152 or can be present within the generator 133. The surgical device 150 is coupled to the generator 133 via a cable 181. The cable 181 transmits signals for the electrosurgical function and the ultrasonic transducer.

[0211] In various aspects, the surgical device 100 is configured to deliver at least two energy types (e.g., ultrasonic, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue located within the end effector 110 between the clamp arm 111 and the ultrasonic blade 116. The housing 102 of the surgical device 100 includes a first activation button switch 126 for activating the energy and a second, "mode" button switch 130 for selecting the energy mode for the activation button switch. The second button switch 130 is connected to a circuit that defines the energy mode using at least one input parameter. The input parameter can be remotely modified via connection to the generator or software update. The energy mode is displayed on the user interface 128.

[0212] In one aspect, the surgical instrument 150 provides mode switching via a direction selector "mode" button switch 180 on the device. The user can press the mode button switch 180 to switch modes from among different overall modes, and the colored light on the user interface 178 indicates the selected mode.

[0213] According to various aspects of the present disclosure, different operating modes can be assigned to the surgical device by pressing the "mode" button switch 180, but each time the mode button switch 180 is pressed or pressed and held, the surgical device 150 switches modes from among the available modes displayed on the user interface 178. Once a particular mode is selected, the generator 133 provides an appropriate tone representing the generator, and the surgical device 150 has a lighted indicator on the user interface 178 to indicate which mode has been selected.

[0214] In the example shown in FIG. 88, the "Mode" selection button switch 180 is disposed on the back surface of the surgical device 150. Since the position of the "Mode" selection button switch 180 is outside the reach of the hand of the surgeon holding the surgical device 150, another hand is required to change the mode. This is intended to prevent inadvertent operation. To change the mode, the surgeon must intentionally press the mode button switch 180 using another hand. In addition to the tone representing the generator, the lighting indicator on the user interface 178 of the surgical device 150 gives the surgeon feedback on which mode is selected.

[0215] FIG. 89A shows a first mode selection option, where colored light indicates the selected mode on the user interface 178 when the mode button switch 180 is pressed and sequentially switched to various modes.

[0216] FIG. 89B shows a second mode selection option, where the screen 182 (e.g., liquid crystal display, e-ink) indicates the selected mode when the mode button switch 180 is pressed and sequentially switched to various modes.

[0217] FIG. 89C shows a third mode selection option, where the encoded light 184 indicates the selected mode when the mode button switch 180 is pressed and sequentially switched to various modes.

[0218] FIG. 89D shows a fourth mode selection option, where the encoded button switch emits light to indicate the selected mode when the encoded button switch 180 is selected and the encoded button switch 186 is pressed to select a mode.

[0219] In one aspect, the present disclosure provides an ultrasonic / bipolar RF energy composite surgical device that includes energy activation by trigger closure. As more functions are added to advanced energy surgical devices, additional button switches or controls are added to the surgical device. The additional button switches or controls make these advanced energy surgical devices complex and difficult to use. Further, when using an advanced energy surgical device to suppress bleeding, a user interface that is difficult to use or a function that is difficult to access will take a very important time and attention during the surgery.

[0220] According to the present disclosure, unipolar RF energy or advanced bipolar RF energy is activated by squeezing the trigger past a first closure click to a second actuation click and holding it in the closed state, and the energy activation state continues until the energy delivery is stopped by the power supply in the generator. The energy can also be reapplied immediately, as needed, by slightly releasing the trigger and then squeezing it again.

[0221] FIG. 90 shows a surgical device 190 having a trigger 196 activation mechanism according to at least one aspect of the present disclosure. The surgical device 190 includes a housing 192 that defines a handle 194 in the form of a pistol grip. The housing 192 includes a trigger 196 that, when squeezed, is received within an internal space defined by the handle 194. The housing 192 is coupled to an end effector via a shaft 198 that is rotatable by a knob 202. The surgical device 190 is coupled to a generator 206 via a cable 204. The cable 204 transmits signals for an electrosurgical function and an ultrasonic transducer.

[0222] The trigger 196 is configured to operate the clamp arm portion of the end effector and trigger electrosurgical energy, thus eliminating the start buttons switches 126, 176 shown in FIGS. 86 and 88. The trigger 196 closes the jaws to grasp tissue when closed to a first audible and tactile click, and further closes to a second audible and tactile click to activate electrosurgical energy such as monopolar, bipolar RF, microwave, or IRE energy. The entire sequence is completed by actuating a front button switch that disconnects the use of ultrasonic energy.

[0223] Procedure for operating the surgical device 190: Squeeze the trigger 196 to a first audible and tactile click, confirm the target tissue within the jaws, squeeze the trigger 196 further to a second audible and tactile click, i.e., until a tone indicating the end point is heard, to activate RF energy, and cut the tissue by pressing the ultrasonic front switch 200 until the tissue is divided.

[0224] Modified procedure for operating the surgical instrument 190 for additional functionality: Activate RF energy using the trigger 196 and hold it while simultaneously actuating the front button switch 200 to activate the ultrasonic transducer. This results in a simultaneous application where electrosurgical and ultrasonic energy modalities are delivered to the tissue simultaneously.

[0225] In an alternative implementation, the front button switch 200 for activating ultrasonic energy can be switched to different speeds via a mode selector on the surgical device 190 or on the power generator 206.

[0226] The surgical instruments 100, 150, 190, and related algorithms described above in connection with FIGS. 86 - 90 and comprising the end effectors described in FIGS. 1 - 85 can be implemented in the following surgical hub system in conjunction with, for example, the following generators and modular energy systems.

[0227] FIG. 91 shows an alternative clamping arm comprising a metal clamping jaw, an electrode, a plurality of clamp arm pads, and a gap pad, according to at least one aspect of the present disclosure. FIG. 91 shows an alternative clamping arm 2900 comprising a metal clamping jaw 2904, an electrode 2906, a plurality of clamp arm pads 2920 extending through holes in the electrode 2906, a gap pad 2930, and a gap pad 2910, according to at least one aspect of the present disclosure. The electrode 2906 is attached to the metal jaw 2906 at a welding location 2908. The electrode 2906 is wrapped around the metal clamping jaw 2904 and the electrode 2906 can be deflected. The gap pad 2910 has an upper PI layer 2912 and a bottom elastomeric layer 2914 for pressure control directly attached to the metal clamping jaw 2904. The clamp arm pads 2920 are directly attached to the metal clamping jaw 2904. Also, the clamp arm pads 2920 are composite pads having a high pressure central zone 2922 made of PTFE for reducing heat and an outer zone 2924 made of PI for deflection of the electrode 2906.

[0228] In one aspect, an ultrasonic / bipolar RF energy composite surgical device is configured to operate within a surgical hub system. FIG. 92 shows a surgical system 3102 comprising a visualization system 3108, a robotic system 3110, and a surgical hub 3106 paired with an intelligent instrument 3112, according to at least one aspect of the present disclosure. Referring now to FIG. 92, the hub 3106 is shown to communicate with a visualization system 3108, a robotic system 3110, and a handheld intelligent surgical instrument 3112 configured in a similar manner as the surgical instruments 100, 150, 190 as described in FIGS. 86 - 91. The hub 3106 includes a hub display 3135, an imaging module 3138, a generator module 3140, a communication module 3130, a processor module 3132, and a storage array 3134. In a particular aspect, as shown in FIG. 92, the hub 3106 further includes a smoke evacuation module 3126 and / or a suction / irrigation module 3128.

[0229] During surgery, applying energy to tissue for sealing and / or cutting is generally associated with smoke evacuation, aspiration of excess fluid, and / or perfusion of tissue. Fluid lines, power lines, and / or data lines from different sources often become entangled during surgery. Valuable time may be lost in dealing with this problem during surgery. To untangle the lines, it may be necessary to remove the lines from their corresponding modules, which may require resetting the modules. The modular enclosure 3136 of the hub provides a unified environment for managing power lines, data lines, and fluid lines, reducing the frequency of such line entanglements.

[0230] Aspects of the present disclosure present a surgical hub for use in a surgical procedure involving applying energy to tissue at a surgical site. The surgical hub includes a hub enclosure and a combined generator module slidably receivable within a docking station of the hub enclosure. The docking station includes data contacts and power contacts. The combined generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component housed within a single unit. In one aspect, the combined generator module also includes a smoke evacuation component, at least one energy supply cable for connecting the combined generator module to a surgical instrument, at least one smoke evacuation component configured to discharge smoke, fluid, and / or particulates generated by applying therapeutic energy to tissue, and a fluid line extending from a remote surgical site to the smoke evacuation component.

[0231] In one aspect, the fluid line is a first fluid line, and a second fluid line extends from a remote surgical site to an aspiration and perfusion module slidably received within the hub enclosure. In one aspect, the hub enclosure includes a fluid interface.

[0232] Certain surgical procedures may require the application of two or more energy types to tissue. One energy type may be more beneficial for cutting tissue, while another, different energy type may be more beneficial for sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut the sealed tissue. Aspects of the present disclosure present a solution in which the hub's modular enclosure 136 is configured to house various generators and facilitate interactive communication between them. One advantage of the hub's modular enclosure 136 is that it allows for quick removal and / or replacement of various modules.

[0233] Aspects of the present disclosure provide a modular surgical enclosure for use in a surgical procedure involving the application of energy to tissue, the modular surgical enclosure including a first energy generator module configured to generate a first energy for application to tissue, and a first docking station including a first docking port including first data contacts and first power contacts, the first energy generator module slidably movable into electrical engagement with the power contacts and the data contacts, and the first energy generator module slidably movable out of electrical engagement with the first power contacts and the first data contacts.

[0234] Further to the above, the modular surgical enclosure also includes a second energy generator module configured to generate a second energy for application to tissue, different from the first energy, and a second docking station including a second docking port including second data contacts and second power contacts, wherein the second energy generator module is slidably movable into electrical engagement with the power contacts and the data contacts, and the second energy generator module is slidably movable out of electrical engagement with the second power contacts and the second data contacts.

[0235] In addition, the modular surgical enclosure also includes a communication bus between the first docking port and the second docking port configured to facilitate communication between the first energy generator module and the second energy generator module.

[0236] In one aspect, the present disclosure provides a generator configured to drive an ultrasonic / bipolar RF energy composite surgical device. FIG. 93 shows an example of a generator 3900 according to at least one aspect of the present disclosure. As shown in FIG. 93, the generator 3900 is one form of a generator configured to couple to surgical instruments 100, 150, 190 as described in FIGS. 86 - 92, and is further configured to execute adaptive ultrasonic and electrosurgical control algorithms within a modular communication hub-equipped surgical data network as shown in FIG. 92. The generator 3900 is configured to deliver multiple energy modalities to a surgical instrument. The generator 3900 provides RF signals and ultrasonic signals for delivering energy to the surgical instrument, either alone or simultaneously. The RF signals and ultrasonic signals may be provided alone, in combination, or simultaneously. As described above, at least one generator output portion can deliver multiple energy modalities (e.g., among others, ultrasonic, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy) through a single port, and these signals can be delivered to the end effector individually or simultaneously for treating 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 various signal waveforms based on information stored in a memory (not shown for clarity of the disclosure) coupled to the processor 3902. Digital information related to the waveform is provided to the waveform generator 3904, which includes one or more DAC circuits for converting digital inputs to analog outputs. The analog output is supplied 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 across the power transformer 3908 to the secondary side on the patient isolation side. The first signal of the first energy modality is provided to the surgical instrument between terminals labeled ENERGY1 and RETURN.The second signal of the second energy modality is coupled across capacitor 3910 and provided to the surgical instrument between the terminals labeled ENERGY2 and RETURN. More than two energy modalities may be output, and thus the subscript "n" can be used to indicate that up to n ENERGYn terminals may be provided, where n is understood to be a positive integer greater than or equal to 2. It will also be understood that up to "n" return paths (RETURNn) may be provided without departing from the scope of the present disclosure.

[0237] The first voltage sensing circuit 3912 is coupled across the terminals labeled ENERGY1 and RETURN paths and measures the output voltage therebetween. The second voltage sensing circuit 3924 is coupled across the terminals labeled ENERGY2 and RETURN paths and measures the output voltage therebetween. The current sensing circuit 3914 is disposed in series with the RETURN section on the secondary side of the power transformer 3908 as shown, to measure the output current of any energy modality. If different return paths are provided for each energy modality, a separate current sensing circuit must be provided at each return section. The outputs of the first voltage sensing circuit 3912 and the second voltage sensing circuit 3924 are provided to the corresponding isolation transformers 3916, 3922, respectively, and the output of the current sensing circuit 3914 is provided to another isolation transformer 3918. The outputs of the isolation transformers 3916, 3928, 3922 on the primary side (non-patient isolation side) of the power transformer 3908 are provided to one or more ADC circuits 3926. The digitized output of the ADC circuit 3926 is provided to the processor 3902 for further processing and calculation. The feedback information of the output voltage and output current can be used to calculate, among other parameters, the output impedance, in order to adjust the output voltage and current provided to the surgical instrument. The input / output communication between the processor 3902 and the patient isolation circuit is provided via the interface circuit 3920. Sensors may also communicate electrically with the processor 3902 via the interface circuit 3920.

[0238] In one aspect, the impedance can be determined by the processor 3902 by dividing either the output of the first voltage sensing circuit 3912 connected across the terminals labeled ENERGY1 / RETURN or the output of the second voltage sensing circuit 3924 connected across the terminals labeled ENERGY2 / RETURN by the output of the current sensing circuit 3914 arranged in series with the RETURN section on the secondary side of the power transformer 3908. The outputs of the first voltage sensing circuit 3912 and the second voltage sensing circuit 3924 are provided to separate isolation transformers 3916, 3922, and the output of the current sensing circuit 3914 is provided to another isolation transformer 3916. The digitized voltage sensing measurements and current sensing measurements from the ADC circuit 3926 are provided to the processor 3902 for calculating the impedance. As an example, the first energy modality ENERGY1 may be ultrasonic energy, and the second energy modality ENERGY2 may be RF energy. Nevertheless, in addition to the ultrasonic energy modality and the bipolar RF energy modality or the monopolar RF energy modality, other energy modalities include, among others, irreversible electroporation energy and / or reversible electroporation energy, and / or microwave energy. Also, the example illustrated in FIG. 93 shows that a single return path RETURN may be provided for two or more energy modalities, but in other aspects, multiple return paths RETURNn may be provided for each energy modality ENERGYn. Thus, as described herein, the impedance of the ultrasonic transducer may be measured by dividing the output of the first voltage sensing circuit 3912 by the output of the current sensing circuit 3914, and the impedance of the tissue may be measured by dividing the output of the second voltage sensing circuit 3924 by the output of the current sensing circuit 3914.

[0239] As shown in FIG. 93, a generator 3900 having at least one output port can include a power transformer 3908 having a single output and a plurality of taps. The power transformer 3908 provides power to the end effector in the form of one or more energy modalities, such as, for example, among others, ultrasonic, bipolar RF or monopolar RF, irreversible electroporation energy and / or reversible electroporation energy, and / or microwave energy, depending on the type of treatment of the tissue being performed. For example, the generator 3900 can deliver high voltage and low current energy to drive an ultrasonic transducer, deliver low voltage and high current energy to drive an RF electrode to seal tissue, or deliver energy having a coagulation waveform for spot coagulation using either a monopolar RF electrosurgical electrode or a bipolar RF electrosurgical electrode. The output waveform from the generator 3900 can be inductively, switched, or filtered to provide a frequency to the end effector of the surgical instrument. The connection of the ultrasonic transducer to the output of the generator 3900 will preferably be located between the output labeled ENERGY1 and the output labeled RETURN shown in FIG. 92. In one embodiment, the connection of the RF bipolar electrode to the output of the generator 3900 will preferably be located between the output labeled ENERGY2 and the output labeled RETURN. For monopolar output, the preferred connection will be a connection of the active electrode (e.g., pencil type or other probe) to the ENERGY2 output and a connection of a suitable return pad to the RETURN output.

[0240] Additional details are disclosed in U.S. Patent Application Publication No. 2017 / 0086914, published Mar. 30, 2017, entitled “TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS,” which is hereby incorporated by reference in its entirety.

[0241] In one aspect, the present disclosure provides a modular energy system configured to drive an ultrasonic / bipolar RF energy combined surgical device. FIG. 94 is a diagram of various modules and other components that can be combined to customize the modular energy system according to at least one aspect of the present disclosure. FIG. 95A shows a configuration of a first exemplary modular energy system, including a header module and a display screen representing a graphical user interface (GUI) for relaying information about modules connected to the header module. FIG. 95B shows the modular energy system shown in FIG. 95A mounted on a cart according to at least one aspect of the present disclosure.

[0242] Referring now to FIGS. 93-95B, due to the amount of equipment required to perform surgery, operating rooms around the world are like a tangled web of cords, devices, and people. Most surgical capital equipment is designed to perform a single specialized task, and thus surgical capital equipment tends to be a major cause of this problem. Due to their specialized nature, surgeons need to use multiple different types of devices during the course of a single surgical procedure, and thus operating rooms may be forced to stock two-piece or even more pieces of surgical capital equipment such as energy generators. Each piece of this surgical capital equipment must be individually plugged into a power source and may also be connected to one or more other devices being passed around among the personnel in the operating room, resulting in cord tangles and the need for guidance. Another problem faced in modern operating rooms is that each of these specialized surgical capital equipment has its own user interface and must be controlled independently of other pieces of equipment in the operating room. This complicates the proper control of multiple different devices connected to each other, and users must receive training on and memorize different types of user interfaces (these user interfaces may further change based on the task or surgery being performed in addition to changes between each piece of capital equipment). This cumbersome and complex process may further require more individuals to be present in the operating room and may pose a danger if multiple devices are not properly controlled with respect to each other. Therefore, by integrating surgical capital equipment technology into a single system that can flexibly meet the needs of surgeons and reduce the footprint of surgical capital equipment in the operating room, the user experience will be simplified, the clutter in the operating room will be reduced, and the difficulties and dangers associated with simultaneously controlling multiple pieces of capital equipment will be prevented.Furthermore, by making such a system extensible or customizable, it becomes possible to conveniently incorporate new technologies into existing surgical systems, eliminating the need to replace the entire surgical system or for operating room personnel to learn new user interfaces or equipment controls for each new technology.

[0243] The surgical hub can be configured to interchangeably accept a variety of modules that can interface with surgical devices (e.g., surgical instruments or smoke evacuators) or provide a variety of other functions (e.g., communications). In one aspect, the surgical hub can be embodied as a modular energy system 4000, shown in connection with FIGS. 94-95B. The modular energy system 4000 can include a variety of different modules 4001 that are connectable to one another in a stacked configuration. In one aspect, the modules 4001 can be physically and communicatively coupled when stacked or otherwise connected together into a single assembly. Furthermore, the modules 4001 can be interchangeably connectable to one another in different combinations or arrangements. In one aspect, each of the modules 4001 can include a consistent or universal array of connectors disposed along their upper and lower surfaces, thereby allowing any module 4001 to be connected to another module 4001 in any arrangement (although in some aspects, a particular module type, such as a header module 4002, can be configured to function as the top-most module in a stack, for example). In an alternative aspect, the modular energy system 4000 can include a housing configured to receive and hold the module 4001, as shown in FIG. 92. The modular energy system 4000 can also include a variety of different components or accessories that can be connected to or otherwise associated with the module 4001. In another aspect, the modular energy system 4000 can be embodied as a generator module 3140, 3900 of the surgical hub 3106 (FIGS. 92-93). In yet another aspect, the modular energy system 4000 can be a system separate from the surgical hub 3106. In such an embodiment, the modular energy system 4000 may be communicatively coupleable to the surgical hub 3106 for transmitting and / or receiving data therebetween.

[0244] The modular energy system 4000 can be assembled from a variety of different modules 4001, some examples of which are shown in FIG. 94. Each of the different types of modules 4001 can provide different functions, thereby allowing the modular energy system 4000 to be assembled into different configurations to customize the functionality and capabilities of the modular energy system 4000 by customizing the modules 4001 included in each modular energy system 4000. The modules 4001 of the modular energy system 4000 can include, for example, a header module 4002 (which can include a display screen 4006), an energy module 4004, a technology module 4040, and a visualization module 4042. In the embodiment shown, the header module 4002 is configured to function as the top or uppermost module in the modular energy system stack and therefore may lack connectors along its top surface. In another embodiment, the header module 4002 can be configured to be positioned at the bottom or be the bottom module in the modular energy system stack and therefore may lack connectors along its bottom surface. In yet another aspect, the header module 4002 can be configured to be positioned in an intermediate position within the modular energy system stack and, therefore, can include connectors along both its bottom and top surfaces. The header module 4002 can be configured to control system-wide settings for each module 4001 and its connected components through physical controls 4011 on the header module 4002 and / or through a graphical user interface (GUI) 4008 displayed on the display screen 4006. Such settings could include activation of the modular energy system 4000, alarm volume settings, footswitch settings, settings icons, user interface appearance or configuration, surgeon profile logged into the modular energy system 4000, and / or the type of surgical procedure being performed.The header module 4002 may also be configured to provide communication, processing, and / or power for the modules 4001 connected to the header module 4002. The energy module 4004, which may also be referred to as a generator module 3140, 3900 (FIGS. 92-93), may be configured to generate one or more energy modalities for driving electrosurgical and / or ultrasonic surgical instruments connected to the energy module 4004, such as those described above in connection with the generator 3900 shown in FIG. 93. The technology module 4040 may be configured to provide additional or extended control algorithms (e.g., electrosurgical or ultrasonic control algorithms for controlling the energy output of the energy module 4004). The visualization module 4042 may be configured to interface with a visualization device (i.e., a scope) and therefore may provide enhanced visualization capabilities.

[0245] The modular energy system 4000 may further include various accessories 4029 connectable to the module 4001 to control the functionality of the module 4001 or otherwise configured to function in conjunction with the modular energy system 4000. The accessories 4029 may include, for example, a single pedal footswitch 4032, a dual pedal footswitch 4034, and a cart 4030 for supporting the modular energy system 4000 thereon. The footswitches 4032, 4034 may be configured, for example, to control the activation or function of a particular energy modality output by the energy module 4004.

[0246] By utilizing modular components, the illustrated modular energy system 4000 provides a surgical platform that grows with technology availability and is customizable to fit the needs of the facility and / or surgeon. Additionally, the modular energy system 4000 supports multiple devices (e.g., dual electrosurgical and ultrasonic energy generators) and software-driven algorithms for customized effects on tissue. Still further, the surgical system architecture reduces the capital equipment footprint by combining multiple technologies critical to the procedure into a single system.

[0247] The various modular components available in connection 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, and various other modules and / or components, some of which have also been previously described in connection with FIGS. 1-91.

[0248] 95A , the header module 4002, in some embodiments, may include a display screen 4006 that displays a GUI 4008 for relaying information regarding the modules 4001 connected to the header module 4002. In some embodiments, the GUI 4008 of the display screen 4006 may provide a unified control point for all of the modules 4001 that make up a particular configuration of the modular energy system 4000. In alternative embodiments, the header module 4002 may lack the display screen 4006, or the display screen 4006 may be removably connected to the housing 4010 of the header module 4002. In such embodiments, the header module 4002 may be communicatively coupleable to an external system configured to display information generated by the modules 4001 of the modular energy system 4000. For example, in robotic surgical applications, the modular energy system 4000 may be communicatively coupled to a robotic cart or robotic control console configured to display information generated by the modular energy system 4000 to an operator of the robotic surgical system. As another example, the modular energy system 4000 may be communicatively coupled to a mobile display carried by or attached to a surgical staff member to enable information to be viewed on the mobile display. In yet another example, the modular energy system 4000 may be communicatively coupled to a surgical hub 4100 or to another computer system that may include a display 4104. In embodiments utilizing a user interface that is separate or otherwise distinct from the modular energy system 4000, the user interface may be wirelessly connectable to the modular energy system 4000 as a whole, or to one or more of the modules 4001, such that the user interface can display information from the connected modules 4001.

[0249] Referring further to FIG. 95A, the energy module 4004 can include a port assembly 4012 that includes a number of different ports, where the ports are configured to deliver different energy modalities to corresponding surgical instruments connectable to each port. In the particular embodiment shown in FIGS. 94-95B, the port assembly 4012 includes a bipolar port 4014, a first monopolar port 4016a, a second monopolar port 4018b, a neutral port 4018 (the port to which a monopolar return pad can be connected), and a composite energy port 4020. However, this particular combination of ports is provided for illustrative purposes only, and alternative combinations of ports and / or energy modalities may be possible for the port assembly 4012.

[0250] As described above, the modular energy system 4000 can be assembled into different configurations. Further, the different configurations of the modular energy system 4000 may also be available for different types of surgical procedures and / or different tasks. For example, FIGS. 95A and 95B show a first exemplary configuration of the modular energy system 4000 that includes a header module 4002 (including a display screen 4006) connected together with an energy module 4004. Such a configuration may be suitable, for example, for laparoscopic and open abdominal surgeries.

[0251] Figures 96-100 illustrate an exemplary surgical system 10 having ultrasonic and electrosurgical capabilities, including any one of the end effectors, surgical instruments, and generators described herein. FIG. 96 shows a surgical system 10 including a generator 12 and a surgical instrument 14. The surgical instrument 14 is operably coupled to the generator 12 via a power cable 16. The generator 12 is operable to supply power to the surgical instrument 14 and deliver ultrasonic energy for cutting tissue and bipolar RF energy (i.e., therapeutic level RF energy) for sealing tissue. In one aspect, the generator 12 is configured to supply power to the surgical instrument 14 to deliver ultrasonic energy and bipolar RF energy simultaneously or independently of each other.

[0252] The surgical instrument 14 of the present embodiment includes a handle assembly 18, a shaft assembly 20 extending distally from the handle assembly 18, and an end effector 22 disposed at the distal end of the shaft assembly 20. The handle assembly 18 includes a body 24 that includes a pistol grip 26 and energy control buttons 28, 30 configured to be operated by a surgeon. A trigger 32 is coupled to the lower portion of the body 24. As described in more detail below, the trigger 32 is pivotable toward and away from the pistol grip 26 to selectively activate the end effector 22. In other suitable variations of the surgical instrument 14, the handle assembly 18 may comprise, for example, a scissor grip configuration. An ultrasonic transducer 34 is housed within and supported by the body 24. In other configurations, the ultrasonic transducer 34 may be provided outside of the body 24.

[0253] As shown in FIGS. 97 and 98, the end effector 22 includes an ultrasonic blade 36 and a clamp arm 38. The clamp arm 38 is selectively pivotable toward and away from the ultrasonic blade 36 and is configured to clamp tissue between the ultrasonic blade 36. The ultrasonic blade 36 is acoustically coupled to an ultrasonic transducer 34. The ultrasonic transducer 34 is configured to drive (i.e., vibrate) the ultrasonic blade 36 at an ultrasonic frequency to cut and / or seal tissue positioned in contact with the ultrasonic blade 36. The clamp arm 38 is operably coupled to a 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. Further, the clamp arm 38 is configured to pivot away from the ultrasonic blade 36 to an open position in response to pivoting of the trigger 32 away from the pistol grip 26 (see, e.g., FIGS. 96-98). In view of the teachings described herein, various suitable ways of coupling the clamp arm 38 to the trigger 32 will be apparent to those of ordinary skill in the art. In some variations, one or more elastic members may be incorporated to bias the clamp arm 38 and / or the trigger 32 toward the open position.

[0254] The clamp pad 40 is fixed to the clamp side of the clamp arm 38 facing the ultrasonic blade 36 and extends distally along the clamp side. The clamp pad 40 is configured to engage a corresponding tissue treatment portion of the ultrasonic blade 36 and clamp the tissue against that portion when the clamp arm 38 is actuated to its closed position. At least on the clamp side of the clamp arm 38, a first electrode 42, referred to herein as the clamp arm electrode 42, is provided. In addition, at least on the clamp side of the ultrasonic blade 36, a second electrode 44, referred to herein as the blade electrode 44, is provided. The electrodes 42, 44 are configured to apply electrosurgical bipolar RF energy provided by the generator 12 to tissue that is electrically coupled to the electrodes 42, 44. The clamp arm electrode 42 functions as the active electrode, while the blade electrode 44 may function as the return electrode, or vice versa. The surgical instrument 14 may be configured to apply electrosurgical bipolar RF energy through the electrodes 42, 44 while the ultrasonic blade 36 is vibrating at an ultrasonic frequency, before the ultrasonic blade 36 is vibrated at an ultrasonic frequency, and / or after the ultrasonic blade 36 has been vibrated at an ultrasonic frequency.

[0255] As shown in FIGS. 96 to 100, the shaft assembly 20 extends along the longitudinal axis and includes an outer tube 46, an inner tube 48 received within the outer tube 46, and an ultrasonic waveguide 50 supported within the inner tube 48. As best seen in FIGS. 97 to 100, the clamp arm 38 is connected to the distal ends of the inner tube 48 and the outer tube 46, respectively. Specifically, the clamp arm 38 includes a pair of clevis arms 52 that extend in the proximal direction, and the clevis arms 52 receive the distal end 54 of the inner tube 48 therebetween and are pivotally connected to the distal end 54 of the inner tube 48 by a pivot pin 56 received through through holes formed in the clevis arms 52 and the distal end 54 of the inner tube 48. The first finger 58 and the second clevis finger 58 depend downwardly from the clevis arms 52 and are pivotally connected to the distal end 60 of the outer tube 46. Specifically, each clevis finger 58 includes a projection 62 that is rotatably received within a corresponding opening 64 formed in the side wall of the distal end 60 of the outer tube 46.

[0256] In this embodiment, the inner tube 48 is fixed longitudinally relative to the handle assembly 18, and the outer tube 46 is configured to translate along the longitudinal axis of the shaft assembly 20 relative to the inner tube 48 and the handle assembly 18. As the outer tube 46 translates in the distal direction, the clamp arm 38 pivots about the pivot pin 56 toward its open position. As the outer tube 46 translates in the proximal direction, the clamp arm 38 pivots in the opposite direction toward its closed position. The proximal end of the outer tube 46 is operatively coupled to the trigger 32, for example via a linkage assembly, such that actuation of the trigger 32 causes the outer tube 46 to translate relative to the inner tube 48, thereby opening and closing the clamp arm 38. In other suitable configurations not shown herein, the outer tube 46 may be fixed longitudinally, and the inner tube 48 may be configured to translate to move the clamp arm 38 between its open and closed positions.

[0257] The shaft assembly 20 and the end effector 22 are configured to rotate together about the longitudinal axis relative to the handle assembly 18. The retaining pin 66 shown in FIG. 99 extends laterally through the proximal portions of the outer tube 46, the inner tube 48, and the waveguide 50, thereby rotatably connecting these components to each other. In this embodiment, a rotation knob 68 is provided at the proximal end portion of the shaft assembly 20 to facilitate the rotation of the shaft assembly 20 and the end effector 22 relative to the handle assembly 18. The rotation knob 68 is rotatably fixed to the shaft assembly 20 by a retaining pin 66 that extends through a proximal side collar of the rotation knob 68. It will be understood that in other suitable configurations, the rotation knob 68 may be omitted or replaced with an alternative rotational actuation structure.

[0258] As shown in FIG. 100, the ultrasonic waveguide 50 is acoustically coupled to the ultrasonic transducer 34 at its proximal end and to the ultrasonic blade 36 at its distal end, for example, by a screw connection. The illustrated ultrasonic blade 36 is formed integrally with the waveguide 50, and the blade 36 extends directly distally from the distal end of the waveguide 50. In this way, the waveguide 50 functions to acoustically couple the ultrasonic transducer 34 to the ultrasonic blade 36 and transmit ultrasonic mechanical vibrations from the transducer 34 to the blade 36. Thus, the ultrasonic transducer 34, the waveguide 50, and the ultrasonic blade 36 together define an acoustic assembly. In use, the ultrasonic blade 36 is placed in direct contact with the tissue, with or without the auxiliary clamping force provided by the clamp arm 38, and applies ultrasonic vibration energy to the tissue, thereby cutting and / or sealing the tissue. For example, the blade 36 can cut tissue clamped between the clamp arm 38 and the first treatment side of the blade 36, or the blade 36 can cut tissue positioned in contact with the second treatment side disposed on the opposite side of the blade 36, for example, during a "retraction cut" movement. In some variations, the waveguide 50 can amplify the ultrasonic vibrations delivered to the blade 36. Further, the waveguide 50 can include various mechanisms operable to control the gain of the vibration and / or mechanisms suitable for tuning the waveguide 50 to a selected resonant frequency. Further mechanisms of the ultrasonic blade 36 and the waveguide 50 are described in more detail below.

[0259] As shown in FIGS. 99 to 100, 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. Specifically, the node support elements 70 are arranged longitudinally along the waveguide 50 at positions corresponding to the acoustic nodes defined by the resonant ultrasonic vibrations transmitted through the waveguide 50. The node support elements 70 can provide structural support for the waveguide 50, and further, can also provide acoustic insulation between the waveguide 50 and the inner tube 48 and the outer tube 46 of the shaft assembly 20. In a variant, the node support element 70 may include an O-ring. The waveguide 50 is supported at its most distal acoustic node by a node support element in the form of an overmolded member 72 shown in FIG. 100. The waveguide 50 is longitudinally rotatably fixed within the shaft assembly 20 by a retaining pin 66 passing through a lateral through-hole 74 formed at an acoustic node disposed proximal to the waveguide 50, such as the most proximal acoustic node, for example.

[0260] In this embodiment, the distal tip 76 of the ultrasonic blade 36 is at a position corresponding to the antinode associated with the resonant ultrasonic vibrations transmitted through the waveguide 50. With such a configuration, when the ultrasonic blade 36 is not filled with tissue, the acoustic assembly of the instrument 14 can be tuned to a preferred resonant frequency f o . When the ultrasonic transducer 34 is energized by the generator 12 to transmit mechanical vibrations to the blade 36 through the waveguide 50, the distal tip portion 76 of the blade 36 vibrates longitudinally at a predetermined vibration frequency f o in the range between peaks of about 20 to 120 micrometers, for example, in the range of about 20 to 50 micrometers in some cases, for example, at about 50 kHz. When the ultrasonic blade 36 is positioned in contact with the tissue, the ultrasonic vibrations of the blade 36 can simultaneously provide a coagulation effect with minimal heat diffusion by cutting the tissue and denaturing the proteins within adjacent tissue cells.

Embodiment

[0261] Examples of various aspects of the end effectors and surgical instruments of the present disclosure are provided below. Aspects of the end effector or surgical instrument may include any one or more, and any combination, of the examples described below.

[0262] Example 1. An end effector comprising a clamp arm and an ultrasonic blade configured to acoustically couple to an ultrasonic transducer and electrically couple to one pole of an electrical generator, the clamp arm comprising a clamp jaw, a cantilever electrode configured to electrically couple to the opposite pole of the electrical generator, the cantilever electrode being fixed to the clamp jaw at a proximal end and freely deflecting at a distal end, and a control function for adjusting a tissue path relative to the clamp arm to create a predetermined contact location.

[0263] Example 2. The end effector of example 1, wherein the control function is configured to reduce charring of tissue and sticking to the clamp arm.

[0264] Example 3. An end effector described in any one of Examples 1 to 2, wherein the clamping jaws have raised side walls for surrounding the cantilever electrode, the raised side walls preventing exposure and preventing tissue from entering the area inside the raised side walls.

[0265] Example 4. The end effector of example 3, wherein a raised sidewall surrounding the cantilever electrode is extruded onto and around the clamp arm pad.

[0266] Example 5. An end effector according to any one of Examples 1 to 4, wherein the clamp arm pad comprises exposed teeth that prevent tissue from entering an area inside the exposed teeth.

[0267] Example 6. An end effector described in any one of Examples 1 to 5, wherein the clamp jaws have raised side walls and a raised lip that prevent tissue from accumulating inside the raised side walls and the raised lip.

[0268] Example 7. The end effector according to Example 6, wherein the clamp arm pad comprises a plurality of teeth.

[0269] Example 8. An end effector comprising a clamp arm and an ultrasonic blade acoustically coupled to an ultrasonic transducer and configured to be electrically coupled to one pole of an electrical generator, wherein the clamp arm is configured to be electrically coupled to the opposite pole of the clamp jaw and the electrical generator, and is fixed to the clamp jaw at the proximal end and is a cantilever electrode that deflects freely at the distal end, and a control function unit for adjusting the tissue path with respect to the ultrasonic blade to create a predetermined contact position.

[0270] Example 9. The end effector according to Example 8, wherein the control function unit is configured to reduce carbonization of the tissue and adhesion to the ultrasonic blade.

[0271] Example 10. The end effector according to any one of Examples 8 to 9, wherein the clamp jaw comprises a guard for surrounding the cantilever electrode, and the guard prevents exposure and prevents tissue from entering the area inside the guard.

[0272] Example 11. The end effector according to Example 10, wherein the guard surrounding the cantilever electrode is extruded outside and around the clamp arm pad.

[0273] Example 12. The end effector according to any one of Examples 8 to 11, wherein the clamp arm pad comprises exposed teeth, and the exposed teeth prevent tissue from entering the area inside the exposed teeth.

[0274] Example 13. The end effector according to any one of Examples 8 to 12, wherein the clamp jaw comprises a guard and a raised lip, and the raised side wall and the raised lip prevent tissue from accumulating inside the raised side wall and the raised lip.

[0275] Example 14. The end effector of example 13, wherein the clamp arm pad comprises a plurality of teeth.

[0276] Example 15. A surgical instrument comprising: a housing; an ultrasonic transducer; an end effector comprising a clamp arm and an ultrasonic blade configured to acoustically couple to the ultrasonic transducer and electrically couple to one pole of an electrical generator; wherein the clamp arm comprises a clamp jaw; a cantilever electrode configured to electrically couple to the opposite pole of the electrical generator, the cantilever electrode fixed to the clamp jaw at a proximal end and freely deflectable at a distal end; and a control function for adjusting a tissue path relative to the clamp arm or the ultrasonic blade to create a predetermined contact position.

[0277] Example 16. The surgical instrument of example 15, wherein the control function is configured to reduce charring and adhesion of tissue to the clamp arm or ultrasonic blade.

[0278] Example 17. A surgical instrument described in any one of Examples 15-16, wherein the clamp jaws have raised side walls or guards to surround the cantilever electrode, the raised side walls or guards preventing exposure and preventing tissue from entering the area inside the raised side walls or guards.

[0279] Example 18. The surgical instrument of Example 17, wherein a raised sidewall or guard surrounding the cantilever electrode is extruded onto and around the clamp arm pad.

[0280] Example 19. A surgical instrument according to any one of Examples 15 to 18, wherein the clamp arm pad comprises exposed teeth that prevent tissue from entering the area inside the exposed teeth.

[0281] Example 20. A surgical instrument described in any one of Examples 15 to 19, wherein the clamp jaws have a raised sidewall or guard and a raised lip, which prevent tissue from accumulating inside the raised sidewall or guard and the raised lip.

[0282] Example 21 The surgical instrument of example 20, wherein the clamp arm pad comprises a plurality of teeth.

[0283] While several embodiments have been shown and described, it is not the applicant's intention to restrict or limit the scope of the appended claims to such details. Numerous modifications, variations, changes, substitutions, combinations, and equivalents of these embodiments may be implemented and will occur to those skilled in the art without departing from the scope of the present disclosure. Moreover, the structure of each element associated with the described embodiments can alternatively be described as a means for providing the function performed by that element. Also, although materials are disclosed with respect to particular components, other materials may be used. It is therefore to be understood that the above description and the appended claims are intended to cover all such modifications, combinations, and variations as fall within the scope of the disclosed embodiments. The appended claims are intended to cover all such modifications, variations, changes, substitutions, modifications, and equivalents.

[0284] The foregoing detailed description has described various forms of apparatus and / or processes using block diagrams, flow diagrams, and / or examples. As long as such block diagrams, flow diagrams, and / or examples include one or more functions and / or operations, those skilled in the art will understand that each function and / or operation included in such block diagrams, flow diagrams, and / or examples can be implemented individually and / or collectively by a variety of hardware, software, firmware, or virtually any combination thereof. It should be understood by those skilled in the art that all or part of some aspects of the forms disclosed herein can be implemented equivalently on an integrated circuit as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or in virtually any combination thereof, and that designing the circuitry and / or writing the code for the software and / or firmware is within the scope of the skills of those skilled in the art in view of the present disclosure. Additionally, it should be understood by those skilled in the art that the mechanisms of the subject matter described herein can be distributed in a variety of forms as one or more program products, and that the specific forms of the subject matter described herein apply regardless of the particular type of signal-carrying medium used to actually carry out the distribution.

[0285] The instructions used to program the logic to implement the various disclosed aspects may be stored in system memory such as dynamic random access memory (DRAM), cache, flash memory, or other storage. Further, the instructions may be distributed via a network or by other computer-readable media. Thus, a machine-readable medium can include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), but is not limited to floppy disks, optical disks, compact disks, read only memory (CD-ROM), and magneto-optical disks, read only memory (ROM), random access memory (RAM), erasable programmable read only memory (EPROM), electrically erasable programmable read only memory (EEPROM), magnetic or optical cards, flash memory, or tangible machine-readable storage used to transmit information via the Internet via electrical, optical, acoustic, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Thus, a non-transitory computer-readable medium can include any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).

[0286] When used in any aspect of this specification, the term "control circuit" can refer to, for example, a hardwired circuit, a programmable circuit (e.g., a computer processor including one or more individual instruction processing cores, a processing unit, a processor, a microcontroller, a microcontroller unit, a controller, a digital signal processor (DSP), a programmable logic device (PLD), a programmable logic array (PLA), or a field programmable gate array (FPGA)), a state machine circuit, firmware storing instructions executed by a programmable circuit, and any combination thereof. The control circuit can be embodied, collectively or individually, as a circuit forming part of a larger system such as, for example, an integrated circuit (IC), an application specific integrated circuit (ASIC), a system on chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smartphone, etc. Thus, as used herein, "control circuit" includes, but is not limited to, an electrical circuit having at least one individual electrical circuit, an electrical circuit having at least one integrated circuit, an electrical circuit having at least one application specific integrated circuit, an electrical circuit forming a general-purpose computing device configured by a computer program (e.g., a general-purpose computer configured by a computer program that at least partially executes the processes and / or apparatuses described herein, or a microprocessor configured by a computer program that at least partially executes the processes and / or apparatuses described herein), an electrical circuit forming a memory device (e.g., in the form of a random access memory), and / or an electrical circuit forming a communication device (e.g., a modem, a communication switch, or an optical-electrical facility). One of ordinary skill in the art will recognize that the subject matter described herein may be implemented in analog form, digital form, or some combination thereof.

[0287] When used in any aspect of this specification, the term "logic" can refer to an application, software, firmware, and / or circuitry configured to perform any of the foregoing operations. The software may be embodied as a software package, code, instructions, instruction sets, and / or data recorded on a non-transitory computer-readable storage medium. The firmware may be embodied as code, instructions or instruction sets within a memory device, and / or hard-coded (e.g., non-volatile) data.

[0288] When used in any aspect of this specification, terms such as "component", "system", "module", etc. can refer to a computer-related entity that is either hardware, a combination of hardware and software, software, or software in execution.

[0289] When used in any aspect of this specification, an "algorithm" refers to a self-collision-free sequence of steps leading to a desired result, and a "step" refers to an operation of a physical quantity and / or logical state that is not necessarily required but can take the form of an electrical or magnetic signal capable of being stored, transferred, combined, compared, and otherwise manipulated. It is common practice to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, etc. These and similar terms may be associated with appropriate physical quantities and are merely convenient labels applied to these quantities and / or states.

[0290] Examples of networks include packet-switched networks. Communication devices can communicate with each other using a selected packet-switched network communication protocol. One exemplary communication protocol is the Ethernet communication protocol that enables communication using the Transmission Control Protocol / Internet Protocol (TCP / IP). The Ethernet protocol may conform to or be compatible with the "IEEE 802.3 Standard" published in December 2008 by the Institute of Electrical and Electronics Engineers (IEEE) and / or later versions of the Ethernet standard. Alternatively or additionally, communication devices can communicate with each other using the X.25 communication protocol. The X.25 communication protocol may conform to or be compatible with the standards published by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, communication devices can communicate with each other using the frame relay communication protocol. The frame relay communication protocol may conform to or be compatible with the standards published by the Consultative Committee for International Telegraph and Telephone (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be able to communicate with each other using the Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standards published by the ATM Forum under the title "ATM-MPLS Network Interworking 2.0" in August 2001 and / or later versions of this standard. Of course, different and / or later-developed connection-oriented network communication protocols are equally contemplated herein.

[0291] Unless expressly specified otherwise, as will be apparent from the foregoing disclosure, discussions throughout the foregoing disclosure using terms such as "processing," "computing," "calculating," "determining," "displaying," and the like will be understood to refer to the actions and processing of a computer system or similar electronic computing device that manipulates and transforms data represented as physical (electronic) quantities in the computer system's registers and memory into other data similarly represented as physical quantities in the computer system's memory or registers or other such information storage, transmission, or display device.

[0292] One or more components may be referred to herein as being "configured to," "configurable to," "operable / operative to," "adaptable," "capable to," "conformable / conformed to," etc. Those skilled in the art will understand that "configured to" may generally encompass active components and / or inactive components and / or standby components, unless the context requires otherwise.

[0293] The terms "proximal" and "distal" are used herein with reference to a clinician manipulating the 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 located away from the clinician. It will be further understood that for convenience and clarity, spatial terms such as "vertical," "horizontal," "up," and "down" may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and / or absolute.

[0294] Those skilled in the art will generally understand that the terms used herein, and particularly those used in the appended claims (e.g., the body of the appended claims), are generally intended to be "open" terms (e.g., the term "including" should be construed as "including but not limited to", the term "having" should be construed as "having at least", the term "includes" should be construed as "includes but is not limited to", etc.). Further, where a specific number is intended in an introduced claim recitation, such intent will be clearly recited in the claim, and where there is no such recitation, those skilled in the art will understand that no such intent exists. For example, for purposes of illustration, the following appended claims may include introductory phrases such as "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be construed as suggesting that any particular claim that introduces a claim recitation with an indefinite article such as "a" or "an" is limited to a claim that includes only one such recited item, even if the same claim includes introductory phrases such as "one or more" or "at least one" and the indefinite article "a" or "an" (e.g., "a" and / or "an" should generally be construed as meaning "at least one" or "one or more"). The same holds true when introducing a claim recitation with a definite article.

[0295] Additionally, even when a specific number is explicitly stated in an introduced claim, those skilled in the art will recognize that such a statement should typically be interpreted to mean at least the recited number (e.g., a statement simply stating "two items" without other modifiers generally means at least two items, or two or more items). Furthermore, when notation similar to "at least one of A, B, and C, etc." is used, such syntax is generally intended in the sense that one skilled in the art would understand the notation (e.g., "a system having at least one of A, B, and C" includes, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or all of A, B, and C, etc.). When notation similar to "at least one of A, B, or C, etc." is used, such syntax is generally intended in the sense that one of ordinary skill in the art would understand the notation (e.g., "a system having at least one of A, B, or C" includes, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or all of A, B, and C, etc.). Furthermore, one of ordinary skill in the art will understand that any disjunctive word and / or phrase presenting two or more alternative terms should typically be understood, whether in the specification, claims, or drawings, to contemplate the possibility of including one of those terms, either of those terms, or both of those terms, unless the context requires otherwise. For example, the phrase "A or B" will typically be understood to include the possibilities of "A" or "B" or "A and B."

[0296] Regarding the appended claims, those skilled in the art will understand that the recited operations herein can generally be performed in any order. Also, although the flowcharts of various operations are shown in sequence, it should be understood that the various operations may be performed in an order other than that shown, or may be performed simultaneously. Examples of such alternative orderings may include, unless the context dictates otherwise, repetition, interleaving, interruption, reordering, incremental, preparatory, additional, simultaneous, reverse, or other different orderings. Further, terms such as "responsive to," "associated with," or other past tense adjectives are generally not intended to exclude such variations, unless the context dictates otherwise.

[0297] Any reference to "one aspect," "aspect," "exemplary," "an exemplary," etc. is worth noting in that it means that the particular mechanism, structure, or characteristic described in relation to that aspect is included in at least one aspect. Thus, the phrases "in one aspect," "in an aspect," "exemplarily," and "an exemplarily" that appear in various places throughout this specification do not necessarily all refer to the same aspect. Further, the particular features, structures, or characteristics can be combined in any suitable manner in one or more aspects.

[0298] Any patent application, patent, non-patent publication, or other disclosure material referenced herein and / or listed in any application data sheet is incorporated herein by reference to the extent that the incorporated material is not inconsistent with this specification. In itself and to the extent necessary, the disclosure clearly set forth herein shall supersede any conflicting description incorporated herein by reference. Although it is referred to as being incorporated herein by reference, any content, or portions thereof, that conflict with the current definitions, views, or other disclosure content set forth herein shall be incorporated only to the extent that no conflict arises between the incorporated content and the current disclosure content.

[0299] In summary, many benefits resulting from using the concepts described herein have been described. The above description of one or more forms is presented for purposes of illustration and explanation. It is not intended to be exhaustive or to limit the disclosure to the precise forms disclosed. Modifications or variations are possible in light of the above teachings. One or more forms are selected and described in order to illustrate the principles and practical applications, thereby enabling one of ordinary skill in the art to utilize the various forms with various modifications as suitable for the particular uses contemplated. The claims presented with this specification are intended to define the overall scope.

[0300] 〔Embodiment〕 (1) A clamp arm, An ultrasonic blade acoustically coupled to an ultrasonic transducer and configured to be electrically coupled to one pole of an electric generator, An end effector comprising: wherein the clamp arm a clamp jaw, a cantilever electrode configured to be electrically coupled to the opposite pole of the electric generator, fixed to the clamp jaw at the proximal end, and freely deflected at the distal end, and a control function unit for adjusting the tissue path with respect to the clamp arm to create a predetermined contact position, comprising: an end effector. (2) The end effector according to Embodiment 1, wherein the control function unit is configured to reduce carbonization of tissue and adhesion to the clamp arm. (3) The end effector according to Embodiment 1, wherein the clamp jaw includes a raised side wall for surrounding the cantilever electrode, and the raised side wall prevents exposure and prevents tissue from entering the region inside the raised side wall. (4) The end effector according to Embodiment 3, wherein the raised side wall surrounding the cantilever electrode is extruded outside and around the clamp arm pad. (5) An end effector as described in embodiment 1, wherein the clamp arm pad has exposed teeth that prevent tissue from entering an area inside the exposed teeth.

[0301] (6) An end effector as described in embodiment 1, wherein the clamp jaws have raised side walls and raised lips that prevent tissue from accumulating inside the raised side walls and raised lips. (7) An end effector as described in embodiment 6, wherein the clamp arm pad comprises a plurality of teeth. (8) a clamp arm; an ultrasonic blade configured to acoustically couple to the ultrasonic transducer and electrically couple to one pole of the electrical generator; An end effector comprising: The clamp arm Clamp jaws, a cantilever electrode configured to be electrically coupled to an opposite pole of the electrical generator, the cantilever electrode being fixed to the clamping jaw at a proximal end and being free to deflect at a distal end; and a control function for adjusting a tissue path for the ultrasonic blade to create a predetermined contact location; Equipped with End effector. (9) The end effector of embodiment 8, wherein the control function is configured to reduce carbonization of tissue and adhesion to the ultrasonic blade. (10) An end effector as described in embodiment 8, wherein the clamp jaw includes a guard for surrounding the cantilever electrode, the guard preventing exposure and preventing tissue from entering the area inside the guard.

[0302] (11) An end effector as described in embodiment 10, wherein the guard surrounding the cantilever electrode is extruded onto and around the clamp arm pad. (12) The end effector according to embodiment 8, wherein the clamp arm pad has exposed teeth that prevent tissue from entering an area inside the exposed teeth. (13) The end effector according to embodiment 8, wherein the clamp jaw has a guard and a raised lip that prevent tissue from accumulating inside the guard and the raised lip. (14) The end effector according to embodiment 13, wherein the clamp arm pad has a plurality of teeth. (15) A housing, An ultrasonic transducer, An end effector comprising: A clamp arm, and An ultrasonic blade acoustically coupled to the ultrasonic transducer and configured to be electrically coupled to one pole of an electrical generator. An end effector; A surgical instrument comprising: Wherein the clamp arm A clamp jaw, A cantilever electrode configured to be electrically coupled to the opposite pole of the electrical generator, fixed to the clamp jaw at its proximal end, and freely deflectable at its distal end, and A control function unit for adjusting a tissue path to the clamp arm or the ultrasonic blade to create a predetermined contact position. Comprising: A surgical instrument.

[0303] (16) The surgical instrument according to embodiment 15, wherein the control function unit is configured to reduce carbonization of tissue and adhesion to the clamp arm or the ultrasonic blade. (17) The surgical instrument according to embodiment 15, wherein the clamp jaw has a raised sidewall or a guard for surrounding the cantilever electrode, and the raised sidewall or the guard prevents exposure and prevents tissue from entering an area inside the raised sidewall or the guard. (18) The surgical instrument according to embodiment 17, wherein the raised sidewall or the guard surrounding the cantilever electrode is extruded outside and around the clamp arm pad. (19) The surgical instrument according to embodiment 15, wherein the clamp arm pad has exposed teeth, and the exposed teeth prevent tissue from entering an area inside the exposed teeth. (20) The surgical instrument according to embodiment 15, wherein the clamp jaw has a raised sidewall or a guard and a raised lip, and the raised sidewall or the guard and the raised lip prevent tissue from accumulating inside the raised sidewall or the guard and the raised lip.

[0304] (21) The surgical instrument according to embodiment 20, wherein the clamp arm pad has a plurality of teeth.

Claims

1. A clamp arm, An ultrasonic blade acoustically coupled to an ultrasonic transducer and configured to be electrically coupled to one pole of an electrical generator, An end effector comprising: wherein the clamp arm comprises A clamp jaw, A clamp arm pad disposed on the clamp jaw, and A cantilever electrode configured to be electrically coupled to the opposite pole of the electrical generator, fixed to the clamp jaw at its proximal end, and freely deflectable at its distal end, the cantilever electrode being disposed on the clamp arm pad and having an opening therethrough, A part of the clamp arm pad protrudes from the opening to adjust the tissue path with respect to the clamp arm and create a predetermined contact position with the tissue, The end effector.

2. The end effector according to claim 1, wherein the cantilever electrode comprises a plurality of the openings arranged in the longitudinal direction of the cantilever electrode.

3. The end effector according to claim 1, wherein the clamp jaw comprises a raised side wall for surrounding the cantilever electrode, the raised side wall preventing exposure and preventing tissue from entering the area inside the raised side wall.

4. The end effector according to claim 3, wherein the raised side wall surrounding the cantilever electrode extends outside and around the clamp arm pad.

5. The end effector according to claim 1, wherein the part of the clamp arm pad defines teeth of the clamp arm pad, and the teeth are exposed from the opening.

6. The end effector according to claim 1, wherein the clamp jaw comprises a raised side wall and a raised lip, the raised side wall extending along the side of the cantilever electrode, and the raised lip extending along the distal end of the cantilever electrode, whereby the raised side wall and the raised lip surround the cantilever electrode and prevent tissue from accumulating inside the raised side wall and the raised lip.

7. The end effector according to claim 6, wherein the clamp arm pad comprises a plurality of teeth.

8. The end effector according to claim 7, wherein the clamp arm pad comprises an upper surface facing the cantilever electrode and a lower surface facing the clamp jaw, and the teeth extend from the upper surface.

9. The end effector according to claim 1, wherein the clamp arm is configured to cooperate with the ultrasonic blade to grip tissue therebetween.

10. A housing, an ultrasonic transducer, an end effector comprising a clamp arm, and an ultrasonic blade acoustically coupled to the ultrasonic transducer and configured to be electrically coupled to one pole of an electrical generator, the end effector comprising a surgical instrument comprising wherein the clamp arm a clamp jaw, a clamp arm pad disposed on the clamp jaw, and a cantilever electrode configured to be electrically coupled to the opposite pole of the electrical generator, fixed to the clamp jaw at the proximal end and freely deflectable at the distal end, the cantilever electrode being disposed on the clamp arm pad and having an opening therethrough, a portion of the clamp arm pad protruding from the opening to adjust the tissue path with respect to the clamp arm and create a predetermined contact position with the tissue, a surgical instrument.

11. The surgical instrument according to claim 10, wherein the clamp jaw comprises a raised sidewall for surrounding the cantilever electrode, the raised sidewall preventing exposure and preventing tissue from entering the region inside the raised sidewall.

12. The surgical instrument according to claim 11, wherein the raised sidewall surrounding the cantilever electrode extends outside and around the clamp arm pad.

13. The surgical instrument according to claim 10, wherein the portion of the clamp arm pad defines teeth of the clamp arm pad, and the teeth are exposed from the opening.

14. The surgical instrument according to claim  10, wherein the clamp jaw comprises a raised sidewall and a raised lip, the raised sidewall extending along the side of the cantilever electrode, and the raised lip extending along the distal end of the cantilever electrode, whereby the raised sidewall and the raised lip surround the cantilever electrode and prevent tissue from accumulating inside the raised sidewall and the raised lip.

15. The surgical instrument according to claim 14, wherein the clamp arm pad comprises a plurality of teeth.

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