SURGICAL INSTRUMENTS, SYSTEMS, AND METHODS INCORPORATING ULTRASONIC AND ELECTROSURGICAL FUNCTIONALITY

Abstract

A surgical system includes a processor and a surgical instrument having an end effector assembly. The end effector assembly includes an ultrasonic blade operably coupled to an ultrasonic transducer for receiving ultrasonic energy produced by the ultrasonic transducer, and a jaw member pivotable relative to the ultrasonic blade between an open position and a closed position for clamping tissue between the ultrasonic blade and the jaw member. The end effector assembly is configured to be activated in an ultrasonic state, in a bipolar state, and in a monopolar state. The processor is configured to determine a use profile of the surgical instrument upon activation of the surgical instrument and, based on the determined use profile, to initiate at least one of the ultrasonic state, the bipolar state, or the monopolar state.

Description

FIELD

The present disclosure relates to energy based surgical instruments and, more particularly, to surgical instruments, systems, and methods incorporating ultrasonic and electrosurgical functionality to facilitate energy based tissue treatment.

BACKGROUND

Ultrasonic surgical instruments and systems utilize ultrasonic energy, i.e., ultrasonic vibrations, to treat tissue. More specifically, ultrasonic surgical instruments and systems utilize mechanical vibration energy transmitted at ultrasonic frequencies to treat tissue. An ultrasonic surgical device may include, for example, an ultrasonic blade and a clamp mechanism to enable clamping of tissue against the blade. Ultrasonic energy transmitted to the blade causes the blade to vibrate at very high frequencies, which allows for heating tissue to treat tissue clamped against or otherwise in contact with the blade.

Electrosurgical instruments and systems conduct Radio Frequency (RF) energy through tissue to treat tissue. An electrosurgical instrument or system may be configured to conduct bipolar RF energy between oppositely charged electrodes and through tissue, e.g., tissue clamped between the electrodes or otherwise in contact therewith, to treat tissue. Alternatively or additionally, an electrosurgical instrument or system may be configured to deliver monopolar RF energy from an active electrode to tissue in contact with the electrode, with the energy returning via a remote return electrode device to complete the circuit.

SUMMARY

As used herein, the term “distal” refers to the portion that is described which is further from an operator (whether a human surgeon or a surgical robot), while the term “proximal” refers to the portion that is being described which is closer to the operator. Terms including “generally,” “about,” “substantially,” and the like, as utilized herein, are meant to encompass variations, e.g., manufacturing tolerances, material tolerances, use and environmental tolerances, measurement variations, and/or other variations, up to and including plus or minus 10 percent. Further, any or all of the aspects described herein, to the extent consistent, may be used in conjunction with any or all of the other aspects described herein.

Provided in accordance with aspects of the present disclosure is a surgical system including a surgical instrument having an end effector assembly including an ultrasonic blade operably coupled to an ultrasonic transducer for receiving ultrasonic energy produced by the ultrasonic transducer, and a jaw member pivotable relative to the ultrasonic blade between an open position and a closed position for clamping tissue between the ultrasonic blade and the jaw member. The end effector assembly is configured to be activated in an ultrasonic state wherein ultrasonic energy is transmitted to tissue via the ultrasonic blade, in a bipolar state wherein electrosurgical energy is conducted between the ultrasonic blade and the jaw member and through tissue disposed therebetween, and in a monopolar state wherein electrosurgical energy is conducted from at least one of the ultrasonic blade or the jaw member to tissue and is returned via a remote return device. The surgical system further includes a processor configured to determine a use profile of the surgical instrument upon activation of the surgical instrument and, based on the determined use profile, to initiate at least one of the ultrasonic state, the bipolar state, or the monopolar state.

In an aspect of the present disclosure, in at least one first use profile, the ultrasonic state and the bipolar state are initiated and the monopolar state is not initiated. In at least one second use profile, the ultrasonic state and the monopolar state are initiated and the bipolar state is not initiated. In aspects, in at least one third use profile, the bipolar state is initiated and the ultrasonic state and the monopolar state are not initiated.

In another aspect of the present disclosure, in at least one first use profile where at least the ultrasonic state is initiated, the ultrasonic energy is supplied in a low power mode. In at least one second use profile where at least the ultrasonic state is initiated, the ultrasonic energy is supplied in a high power mode.

In still another aspect of the present disclosure, in at least one first use profile where at least the monopolar state is initiated, the monopolar energy is supplied in a coagulation (“coag”) mode. In at least one second use profile where at least the monopolar state is initiated, the monopolar energy is supplied in a cut mode.

In yet another aspect of the present disclosure, the processor is configured to determine the use profile based on at least two of, at least three of, or all of: a position of an actuator, a position of the jaw member, a position of an activation button, or temporal considerations. Additionally or alternatively, field conditions, e.g., based on impedance feedback and/or other feedback data, may also be utilized to determine the use profile.

A method of supplying energy in a surgical system provided in accordance with the present disclosure includes determining a use profile of a surgical instrument based upon use of the surgical instrument upon activation, and initiating, based on the determined use profile, at least one state. The at least one state includes: an ultrasonic state, wherein ultrasonic energy is transmitted to tissue via an ultrasonic blade of the surgical instrument; a bipolar state wherein electrosurgical energy is conducted between the ultrasonic blade and a jaw member of the surgical instrument and through tissue disposed therebetween; and a monopolar state wherein electrosurgical energy is conducted from at least one of the ultrasonic blade or the jaw member to tissue and is returned via a remote return device.

In an aspect of the present disclosure, the initiating, in at least one first use profile, includes initiating the ultrasonic state and the bipolar state but not the monopolar state. The initiating, in at least one second use profile, includes initiating the ultrasonic state and the monopolar state but not the bipolar state. The initiating, in at least one third use profile, includes initiating the bipolar state only.

In another aspect of the present disclosure, in at least one first use profile where at least the ultrasonic state is initiated, the initiating includes initiating the ultrasonic energy in a low power mode. In at least one second use profile where at least the ultrasonic state is initiated, the initiating includes initiating the ultrasonic energy in a high power mode.

In yet another aspect of the present disclosure, in at least one first use profile where at least the monopolar state is initiated, the initiating includes initiating the monopolar energy in a coag mode. In at least one second use profile where at least the monopolar state is initiated, the initiating includes initiating the monopolar energy in a cut mode.

In still another aspect of the present disclosure, determining the use profile is based on at least two of, at least three of, or all of: a position of an actuator, a position of the jaw member, a position of an activation button, or temporal considerations. Additionally or alternatively, field conditions, e.g., based on impedance feedback and/or other feedback data, may also be utilized to determine the use profile.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other aspects and features of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings wherein like reference numerals identify similar or identical elements.

FIG. 1 is a side view of a surgical system provided in accordance with the present disclosure including a surgical instrument, a surgical generator, and a return electrode device;

FIG. 2 is perspective view of another surgical system provided in accordance with the present disclosure including a surgical instrument incorporating an ultrasonic generator, electrosurgical generator, and power source therein;

FIG. 3 is a schematic illustration of a robotic surgical system provided in accordance with the present disclosure;

FIG. 4 is a longitudinal, cross-sectional view of a distal end portion of the surgical instrument of FIG. 1;

FIG. 5 is a transverse, cross-sectional view of the end effector assembly of the surgical instrument of FIG. 1;

FIG. 6 is a transverse, cross-sectional view of another configuration of the end effector assembly of the surgical instrument of FIG. 1;

FIG. 7 is a chart in accordance with the present disclosure wherein a use of a surgical instrument or system is categorized into a use profile based on clamp lever position, activation state, jaw member position, and/or temporal relation to prior activation;

FIG. 8 is a chart indicating surgical tasks that may be performed for each of the use profiles of FIG. 7;

FIG. 9 is a chart indicating the energy modalities that may be activated for each of the use profiles of FIG. 7; and

FIG. 10 is a chart indicating the energy modalities and that may be activated, and the level of activation for certain energy modalities, for each of the use profiles of FIG. 7.

DETAILED DESCRIPTION

Referring to FIG. 1, a surgical system provided in accordance with aspects of the present disclosure is shown generally identified by reference numeral 10 including a surgical instrument 100, a surgical generator 200, and, in some aspects, a return electrode device 500, e.g., including a return pad 510. Surgical instrument 100 includes a handle assembly 110, an elongated assembly 150 extending distally from handle assembly 110, an end effector assembly 160 disposed at a distal end of elongated assembly 150, and a cable assembly 190 operably coupled with handle assembly 110 and extending therefrom for connection to surgical generator 200.

Surgical generator 200 includes a display 210, a plurality user interface features 220, e.g., buttons, touch screens, switches, etc., an ultrasonic plug port 230, a bipolar electrosurgical plug port 240, and active and return monopolar electrosurgical plug ports 250, 260, respectively. As an alternative to plural dedicated ports 230-260, one or more common ports (not shown) may be configured to act as any two or more of ports 230-260.

Surgical instrument 100 is configured to supply electrosurgical, e.g., Radio Frequency (RF), energy to tissue to treat tissue, e.g., in a monopolar configuration and/or a bipolar configuration, and to supply ultrasonic energy to tissue to treat tissue. Surgical generator 200 is configured to produce ultrasonic drive signals for output through ultrasonic plug port 230 to surgical instrument 100 to activate surgical instrument 100 to supply ultrasonic energy and to provide electrosurgical energy, e.g., RF bipolar energy for output through bipolar electrosurgical plug port 240 and/or RF monopolar energy for output through active monopolar electrosurgical port 250 to surgical instrument 100 to activate surgical instrument 100 to supply electrosurgical energy. Plug 520 of return electrode device 500 is configured to connect to return monopolar electrosurgical plug port 260 to return monopolar electrosurgical energy from surgical instrument 100 during monopolar electrosurgical use.

Continuing with reference to FIG. 1, handle assembly 110 includes a housing 112, an activation button 120, and a clamp lever 130. Housing 112 is configured to support an ultrasonic transducer 140. Ultrasonic transducer 140 may be permanently engaged within housing 112 or removable therefrom. Ultrasonic transducer 140 includes a piezoelectric stack or other suitable ultrasonic transducer components electrically coupled to surgical generator 200, e.g., via one or more of first electrical lead wires 197, to enable communication of ultrasonic drive signals to ultrasonic transducer 140 to drive ultrasonic transducer 140 to produce ultrasonic vibration energy that is transmitted along a waveguide 154 of elongated assembly 150 to blade 162 of end effector assembly 160 of elongated assembly 150, as detailed below. Feedback and/or control signals may likewise be communicated between ultrasonic transducer 140 and surgical generator 200. Ultrasonic transducer 140, more specifically, may include a stack of piezoelectric elements secured, under pre-compression between proximal and distal end masses or a proximal end mass and an ultrasonic horn with first and second electrodes electrically coupled between piezoelectric elements of the stack of piezoelectric elements to enable energization thereof to produce ultrasonic energy. However, other suitable ultrasonic transducer configurations, including plural transducers and/or non-longitudinal, e.g., torsional, transducers are also contemplated.

An activation button 120 is disposed on housing 112 and coupled to or between ultrasonic transducer 140 and/or surgical generator 200, e.g., via one or more of first electrical lead wires 197, to enable activation of ultrasonic transducer 140 in response to depression of activation button 120. In some configurations, activation button 120 may include an ON/OFF switch. In other configurations, activation button 120 may include multiple actuation switches to enable activation from an OFF state to different states corresponding to different activation settings, e.g., a first state corresponding to a first activation setting (such as a LOW power and/or tissue sealing setting) and a second state corresponding to a second activation setting (such as a HIGH power and/or tissue transection setting). In still other configurations, separate activation buttons may be provided, e.g., a first actuation button for activating a first activation setting and a second activation button for activating a second activation setting. Additional activation buttons, sliders, wheels, etc. are also contemplated to enable control of various different activation settings from housing 112.

Elongated assembly 150 of surgical instrument 100 includes an outer drive sleeve 152, an inner support sleeve 153 (FIG. 4) disposed within outer drive sleeve 152, a waveguide 154 extending through inner support sleeve 153 (FIG. 4), a drive assembly (not shown), a rotation knob 156, and an end effector assembly 160 including a blade 162 and a jaw member 164. Rotation knob 156 is rotatable in either direction to rotate elongated assembly 150 in either direction relative to handle assembly 110. The drive assembly operably couples a proximal portion of outer drive sleeve 152 to clamp lever 130 of handle assembly 110. A distal portion of outer drive sleeve 152 is operably coupled to jaw member 164 and a distal end of inner support sleeve 153 (FIG. 4) pivotably supports jaw member 164. As such, clamp lever 130 is selectively actuatable, e.g., between an un-actuated position and a fully actuated position, to thereby move outer drive sleeve 152 about inner support sleeve 153 (FIG. 4) to pivot jaw member 164 relative to blade 162 of end effector assembly 160 from an open position towards a closed position for clamping tissue between jaw member 164 and blade 162. The configuration of outer and inner sleeves 152, 153 (FIG. 4) may be reversed, e.g., wherein outer sleeve 152 is the support sleeve and inner sleeve 153 (FIG. 4) is the drive sleeve. Other suitable drive structures as opposed to a sleeve are also contemplated such as, for example, drive rods, drive cables, drive screws, etc. In aspects, a sensor 132 is provided to sense the position of clamp lever 130. Sensor 132 may be a contact or proximity sensor configured to sense whether clamp lever 130 is disposed in the fully actuated position (based on contact or proximity of clamp lever 130 to sensor 132), or may be any other suitable sensor configured to discretely or continuously sense one or more positions of clamp lever 130, e.g., the un-actuated position, the fully actuated position, and/or one or more positions therebetween, as an absolute distance, relative distance, absolute angle, or relative angle.

Referring still to FIG. 1, the drive assembly may be tuned to provide a jaw clamping force, or jaw clamping force within a jaw clamping force range, to tissue clamped between jaw member 164 and blade 162 or may include a force limiting feature whereby the clamping force applied to tissue clamped between jaw member 164 and blade 162 is limited to a particular jaw clamping force or a jaw clamping force within a jaw clamping force range. Regardless of the particular configuration for jaw clamping force control, and even with the lack thereof, flexibilities, tolerances, and/or deflections in clamp lever 130, the drive assembly, and/or end effector assembly 160 result in a disjunction between the position of clamp lever 130 and the position of jaw member 164 in at least some circumstances. For example, where relatively large diameter tissue, e.g., greater than 7 mm, is clamped between jaw member 164 and blade 162, clamp lever 130 may be moved to a fully actuated position while jaw member 164 is only moved to a partially closed position. On the other hand, and in other circumstances, the position of clamp lever 130 and the position of jaw member 164 may substantially correspond. For example, where relatively small diameter tissue, e.g., less than or equal to 7 mm, is clamped between jaw member 164 and blade 162, clamp lever 130 may be disposed in the fully actuated position and jaw member 164 may be disposed in the fully closed position. It is noted that the “fully actuated” and “fully closed” positions of clamp lever 130 and jaw member 164, respectively, are reference positions or reference ranges of positions and need not be physically limited positions, e.g., wherein clamp lever 130 abuts handle assembly 110 and jaw member 164 abuts blade 162. Indeed, the “fully actuated” and “fully closed” positions of clamp lever 130 and jaw member 164, respectively, may be defined as any positions within an actual distance (measured in distance units, e.g., mm) of a reference component, e.g., handle assembly 110 and blade 162, respectively, or other suitable component(s); may be defined as any positions within actual angles (measured in angular units, e.g., degrees) from reference angles; or may be defined as any positions within relative distances or angles (e.g., as percentages) compared to the full travel distances or travel arcs of clamp lever 130 and jaw member 164.

Waveguide 154, as noted above, extends from handle assembly 110 through inner sleeve 153 (FIG. 4). Waveguide 154 includes blade 162 disposed at a distal end thereof. Blade 162 may be integrally formed with waveguide 154, separately formed and subsequently attached (permanently or removably) to waveguide 154, or otherwise operably coupled with waveguide 154. Waveguide 154 and/or blade 162 may be formed from titanium, a titanium alloy, or other suitable electrically conductive material(s), although non-conductive materials are also contemplated. Waveguide 154 includes a proximal connector (not shown), e.g., a threaded male connector, configured for engagement, e.g., threaded engagement within a threaded female receiver, of ultrasonic transducer 140 such that ultrasonic motion produced by ultrasonic transducer 140 is transmitted along waveguide 154 to blade 162 for treating tissue clamped between blade 162 and jaw member 164 or positioned adjacent to blade 162.

Cable assembly 190 of surgical instrument 100 includes a cable 192, an ultrasonic plug 194, and an electrosurgical plug 196. Ultrasonic plug 194 is configured for connection with ultrasonic plug port 230 of surgical generator 200 while electrosurgical plug 196 is configured for connection with bipolar electrosurgical plug port 240 of surgical generator 200 and/or active monopolar electrosurgical plug port 250 of surgical generator 200. In configurations where generator 200 includes a common port, cable assembly 190 may include a common plug (not shown) configured to act as both the ultrasonic plug 194 and the electrosurgical plug 196.

Plural first electrical lead wires 197 electrically coupled to ultrasonic plug 194 extend through cable 192 and into handle assembly 110 for electrical connection to ultrasonic transducer 140 and/or activation button 120 to enable the selective supply of ultrasonic drive signals from surgical generator 200 to ultrasonic transducer 140 upon activation of ultrasonic energy. In addition, plural second electrical lead wires 199 are electrically coupled to electrosurgical plug 196 and extend through cable 192 into handle assembly 110. In bipolar configurations, separate second electrical lead wires 199 are electrically coupled to waveguide 154 and jaw member 164 (and/or different portions of jaw member 164) such that bipolar electrosurgical energy may be conducted between blade 162 and jaw member 164 (and/or between different portions of jaw member 164). In monopolar configurations, a second electrical lead wire 199 is electrically coupled to waveguide 154 such that monopolar electrosurgical energy may be supplied to tissue from blade 162. Alternatively or additionally, a second electrical lead wire 199 may electrically couple to jaw member 164 in the monopolar configuration to enable monopolar electrosurgical energy to be supplied to tissue from jaw member 164. In configurations where both bipolar and monopolar functionality are enabled, one or more of the second electrical lead wires 199 may be used for both the delivery of bipolar energy and monopolar energy; alternatively, bipolar and monopolar energy delivery may be provided by separate second electrical lead wires 199. One or more other second electrical lead wires 199 is electrically coupled to activation button 120 to enable the selective supply of electrosurgical energy from surgical generator 200 to waveguide 154 and/or jaw member 164 upon activation of electrosurgical energy.

As an alternative to a remote generator 200, surgical system 10 may be at least partially cordless in that it incorporates an ultrasonic generator, an electrosurgical generator, and/or a power source, e.g., a battery, thereon or therein. In this manner, the connections from surgical instrument 100 to external devices, e.g., generator(s) and/or power source(s), is reduced or eliminated. More specifically, with reference to FIG. 2, another surgical system in accordance with the present disclosure is shown illustrated as a surgical instrument 20 supporting an ultrasonic generator 310, a power source (e.g., battery assembly 400), and an electrosurgical generator 600 thereon or therein. Surgical instrument 20 is similar to surgical instrument 100 (FIG. 1) and may include any of the features thereof except as explicitly contradicted below. Accordingly, only differences between surgical instrument 20 and surgical instrument 100 (FIG. 1) are described in detail below while similarities are omitted or summarily described.

Housing 112 of surgical instrument 20 includes a body portion 113 and a fixed handle portion 114 depending from body portion 113. Body portion 113 of housing 112 is configured to support an ultrasonic transducer and generator assembly (“TAG”) 300 including ultrasonic generator 310 and ultrasonic transducer 140. TAG 300 may be permanently engaged with body portion 113 of housing 112 or removable therefrom.

Fixed handle portion 114 of housing 112 defines a compartment 116 configured to receive battery assembly 400 and electrosurgical generator 600 and a door 118 configured to enclose compartment 116. An electrical connection assembly (not shown) is disposed within housing 112 and serves to electrically couple activation button 120, ultrasonic generator 310 of TAG 300, and battery assembly 400 with one another when TAG 300 is supported on or in body portion 113 of housing 112 and battery assembly 400 is disposed within compartment 116 of fixed handle portion 114 of housing 112, thus enabling activation of surgical instrument 20 in an ultrasonic mode in response to appropriate actuation of activation button 120. Further, the electrical connection assembly or a different electrical connection assembly disposed within housing 112 serves to electrically couple activation button 120, electrosurgical generator 600, battery assembly 400, and end effector assembly 160 (e.g., blade 162 and jaw member 164 and/or different portions of jaw member 164) with one another when electrosurgical generator 600 and battery assembly 400 are disposed within compartment 116 of fixed handle portion 114 of housing 112, thus enabling activation of surgical instrument 20 to supply electrosurgical energy, e.g., bipolar RF energy, in response to appropriate actuation of activation button 120. To enable the supply of monopolar electrosurgical energy, plug 520 of return electrode device 500 may be configured to connect to surgical instrument 20 (electrosurgical generator 600 thereof, more specifically), to complete a monopolar circuit through tissue and between surgical instrument 20 (e.g., blade 162 and/or jaw member 164) and return electrode device 500.

Turning to FIG. 3, a robotic surgical system in accordance with the aspects and features of the present disclosure is shown generally identified by reference numeral 1000. For the purposes herein, robotic surgical system 1000 is generally described. Aspects and features of robotic surgical system 1000 not germane to the understanding of the present disclosure are omitted to avoid obscuring the aspects and features of the present disclosure in unnecessary detail.

Robotic surgical system 1000 generally includes a plurality of robot arms 1002, 1003; a control device 1004; and an operating console 1005 coupled with control device 1004. Operating console 1005 may include a display device 1006, which may be set up in particular to display three dimensional images; and manual input devices 1007, 1008, by means of which a person (not shown), for example a surgeon, may be able to telemanipulate robot arms 1002, 1003 in a first operating mode. Robotic surgical system 1000 may be configured for use on a patient 1013 lying on a patient table 1012 to be treated in a minimally invasive manner. Robotic surgical system 1000 may further include a database 1014, in particular coupled to control device 1004, in which are stored, for example, pre-operative data from patient 1013 and/or anatomical atlases.

Each of the robot arms 1002, 1003 may include a plurality of members, which are connected through joints, and an attaching device 1009, 1011, to which may be attached, for example, a surgical tool “ST” supporting an end effector 1050, 1060. One of the surgical tools “ST” may be surgical instrument 100 (FIG. 1), surgical instrument 20 (FIG. 2), or any other suitable surgical instrument 20 configured for use in both an ultrasonic mode and one or more electrosurgical (bipolar and/or monopolar) modes, wherein manual actuation features, e.g., actuation button 120 (FIG. 1), clamp lever 130 (FIG. 1), etc., are replaced with robotic inputs. In such configurations, robotic surgical system 1000 may include or be configured to connect to an ultrasonic generator, an electrosurgical generator, and/or a power source. The other surgical tool “ST” may include any other suitable surgical instrument, e.g., an endoscopic camera, other surgical tool, etc. Robot arms 1002, 1003 may be driven by electric drives, e.g., motors, that are connected to control device 1004. Control device 1004 (e.g., a computer) may be configured to activate the motors, in particular by means of a computer program, in such a way that robot arms 1002, 1003, their attaching devices 1009, 1011, and, thus, the surgical tools “ST” execute a desired movement and/or function according to a corresponding input from manual input devices 1007, 1008, respectively. Control device 1004 may also be configured in such a way that it regulates the movement of robot arms 1002, 1003 and/or of the motors.

Referring to FIGS. 4-6, end effector assembly 160 of surgical instrument 100 of surgical system 10 (FIG. 1) is detailed, although the aspects and features of end effector assembly 160 may similarly apply, to the extent consistent, to surgical instrument 20 (FIG. 2) and/or any other suitable surgical instrument or system. End effector assembly 160, as noted above, includes blade 162 and jaw member 164. Blade 162 may define a linear configuration, may define a curved configuration, or may define any other suitable configuration, e.g., straight and/or curved surfaces, portions, and/or sections; one or more convex and/or concave surfaces, portions, and/or sections; etc. With respect to curved configurations, blade 162, more specifically, may be curved in any direction relative to jaw member 164, for example, such that the distal tip of blade 162 is curved towards jaw member 164, away from jaw member 164, or laterally (in either direction) relative to jaw member 164. Further, blade 162 may be formed to include multiple curves in similar directions, multiple curves in different directions within a single plane, and/or multiple curves in different directions in different planes. In addition, blade 162 may additionally or alternatively be formed to include any suitable features, e.g., a tapered configuration, various different cross-sectional configurations along its length, cut outs, indents, edges, protrusions, straight surfaces, curved surfaces, angled surfaces, wide edges, narrow edges, and/or other features.

Blade 162 may define a polygonal, rounded polygonal, or any other suitable cross-sectional configuration(s). Waveguide 154 or at least the portion of waveguide 154 proximally adjacent blade 162, may define a cylindrical shaped configuration. Plural tapered surfaces (not shown) may interconnect the cylindrically shaped waveguide 154 with the polygonal (rounded edge polygonal, or other suitable shape) configuration of blade 162 to define smooth transitions between the body of waveguide 154 and blade 162.

Blade 162 may be wholly or selectively coated with a suitable material, e.g., a non-stick material, an electrically insulative material, an electrically conductive material, combinations thereof, etc. Suitable coatings and/or methods of applying coatings include but are not limited to Teflon®, polyphenylene oxide (PPO), deposited liquid ceramic insulative coatings; thermally sprayed coatings, e.g., thermally sprayed ceramic; Plasma Electrolytic Oxidation (PEO) coatings; anodization coatings; sputtered coatings, e.g., silica; ElectroBond® coating available from Surface Solutions Group of Chicago, IL, USA; or other suitable coatings and/or methods of applying coatings.

Continuing with reference to FIGS. 4-6, blade 162, as noted above, in addition to receiving ultrasonic energy transmitted along waveguide 154 from ultrasonic transducer 140 (FIG. 1), is adapted to connect to generator 200 (FIG. 1) to enable the supply of RF energy to blade 162 for conduction to tissue in contact therewith. In bipolar configurations, RF energy is conducted between blade 162 and jaw member 164 (or between portions of jaw member 164 and/or blade 162) and through tissue disposed therebetween to treat tissue. In monopolar configurations, RF energy is conducted from blade 162, serving as the active electrode, to tissue in contact therewith and is ultimately returned to generator 200 (FIG. 1) via return electrode device 500 (FIG. 1), serving as the passive or return electrode.

Jaw member 164 of end effector assembly 160 includes more rigid structural body 182 and more compliant jaw liner 184. Structural body 182 may be formed from an electrically conductive material, e.g., stainless steel, and/or may include electrically conductive portions. Structural body 182 includes a pair of proximal flanges 183a that are pivotably coupled to the inner support sleeve 153 via receipt of pivot bosses (not shown) of proximal flanges 183a within corresponding openings (not shown) defined within the inner support sleeve 153 and operably coupled with outer drive sleeve 152 via a drive pin 155 secured relative to outer drive sleeve 152 and pivotably received within apertures 183b defined within proximal flanges 183a. As such, sliding of outer drive sleeve 152 about inner support sleeve 153 pivots jaw member 164 relative to blade 162 from the open position towards the closed position to clamp tissue between jaw liner 184 of jaw member 164 and blade 162.

With reference to FIG. 5, structural body 182 may be adapted to connect to a source of electrosurgical energy, e.g., generator 200 (FIG. 1), and, in a bipolar configuration, is charged to a different potential as compared to blade 162 to enable the conduction of bipolar electrosurgical (e.g., RF) energy through tissue clamped therebetween, to treat the tissue. In a monopolar configuration, structural body 182 may be un-energized, may be charged to the same potential as compared to blade 162 (thus both defining the active electrode), or may be energized while blade 162 is not energized (wherein structural body 182 defines the active electrode). In either monopolar configuration, energy is returned to generator 200 (FIG. 1) via return electrode device 500 (FIG. 1), which serves as the passive or return electrode.

Referring to FIG. 6, as an alternative to the entirety of structural body 182 of jaw member 164 being connected to generator 200 (FIG. 1), the structural body may be formed from or embedded at least partially in an insulative material, e.g., an overmolded plastic. In such configurations, electrically conductive surfaces 188, e.g., in the form of plates, may be disposed on or captured by the overmolded plastic to define electrodes on either side of jaw liner 184 on the blade facing side of jaw member 164. The electrically conductive surfaces 188, in such aspects., are connected to generator 200 (FIG. 1) and may be energized for use in bipolar and/or monopolar configurations, e.g., energized to the same potential as one another and/or blade 162 and/or different potentials as one another and/or blade 162. In aspects, electrically conductive surfaces 188 are disposed at additional or alternative locations on jaw member 164, e.g., along either or both sides thereof, along a back surface thereof, etc.

Returning to FIGS. 4-6, jaw liner 184 is shaped complementary to a cavity 185 defined within structural body 182, e.g., defining a T-shaped configuration, to facilitate receipt and retention therein, although other configurations are also contemplated. Jaw liner 184 is fabricated from an electrically insulative, compliant material such as, for example, polytetrafluoroethylene (PTFE). The compliance of jaw liner 184 enables blade 162 to vibrate while in contact with jaw liner 184 without damaging components of ultrasonic surgical instrument 100 (FIG. 1) and without compromising the hold on tissue clamped between jaw member 164 and blade 162. Jaw liner 184 extends from structural body 182 towards blade 162 to inhibit contact between structural body 182 and blade 162 in the closed position of jaw member 164. The insulation of jaw liner 184 maintains electrical isolation between blade 162 and structural body 182 of jaw member 164, thereby inhibiting shorting.

In aspects, a sensor 161 is provided on or within end effector assembly 160. Sensor 161 may be any suitable sensor, e.g., a motion sensor, a proximity sensor, a contact sensor, etc., configured to sense whether jaw member 164 is disposed in the fully closed position, an extent to which jaw member 164 is closed, and/or an overall position of jaw member 164. Sensor 161 may be configured to discretely or continuously sense one or more positions of jaw member 164, e.g., the open position, the fully closed position, and/or one or more positions therebetween, as an absolute distance, relative distance, absolute angle, or relative angle. Sensor 161 may sense the position of jaw member 164 directly or indirectly, e.g., via sensing the position of one or more components coupled to jaw member 164 such as, for example, outer drive sleeve 152 and/or drive pin 155. Alternatively, sensor 161 may be disposed on or incorporated into a separate device, e.g., a surgical camera, configured to detect the position of jaw member 164.

With reference to FIG. 7, depending upon a surgical task to be performed and/or other factors, the use of a surgical instrument or system, e.g., surgical instrument 100 (FIG. 1), surgical instrument 20 (FIG. 2), or surgical system 1000 (FIG. 3), may vary. For example: the clamp lever (or other actuator) of the instrument or system may be fully actuated, partially actuated, or remain substantially un-actuated; the jaw member of the instrument or system may be fully closed or partially opened (even with the clamp lever in the fully actuated position); the activation button may be actuated to a particular state (or a particular activation device amongst a plurality of activation devices may be actuated to a particular state); and/or an activation may or may not occur in a defined temporal relation to a prior activation. Considering some or all of these variable features together, a use of a surgical instrument or system can be categorized into a use profile, e.g., corresponding to one or more surgical tasks to be performed.

In aspects, the use of a surgical instrument or system may be categorized at the time of activation and/or a change in condition (e.g., a change in activation, clamp lever position, jaw member position, etc.). With respect to surgical instrument 100 (FIG. 1) for example, the use may be categorized at the time of activation of activation button 120 (FIG. 1). The other variables may be determined based on sensed feedback and/or in any other suitable manner at the time of activation or any other suitable time. With respect to surgical instrument 100 (FIG. 1) for example, the position of clamp lever 130 (or whether clamp lever 130 is in the fully actuated position) may be determined by sensor 132 (see FIG. 1); the position of jaw member 164 (or whether jaw member 164 is fully closed or at least partially open) may be determined by sensor 161 (see FIG. 4); the activation state of activation button 120 (FIG. 1) may be known based on the signal(s) associated with actuation thereof; and/or activation information may be stored together with timestamp information to enable temporal considerations to be taken into account, e.g., a temporal relation between the start of an activation and the status of the sensed feedback, a temporal relation between activations, etc. This feedback information may be communicated to a processor, e.g., of generator 200 (FIG. 1), for determining a use profile based thereon, e.g., using a look-up table, algorithm, machine learning program, etc. The processor may further direct output of appropriate energy modalities and/or settings, e.g., ultrasonic, bipolar RF, and/or monopolar RF energy at appropriate energy levels, based on the determined use profile.

Continuing with reference to FIG. 7, a use may be categorized in use profile “A” when it is determined that the clamp lever is not fully actuated (i.e., is in any position but the fully-actuated position) and that the instrument or system is activated in a first state corresponding to a first activation setting (such as a LOW power and/or tissue sealing setting). This categorization may be made regardless of the jaw member position and/or temporal considerations.

A use may be categorized in use profile “B” when it is determined that the instrument or system is activated in a second state corresponding to a second activation setting (such as a HIGH power and/or tissue cutting setting). This categorization may be made regardless of the clamp lever position, the jaw member position, and/or temporal considerations.

Uses are categorized in one of use profiles “C,” “D,” “E,” or “F” when it is determined that the clamp lever is fully actuated and that instrument or system is activated in the first state corresponding to the first activation setting. Where it is further determined that the jaw member is fully closed and that the time since the start of the activation is less than a predefined threshold and/or no prior tissue seals have been completed (within a predefined threshold), the use is categorized in use profile “C.” Alternatively, where it is further determined that the jaw member is fully closed and that: the time since the start of the activation is longer than a predefined threshold; and/or that a tissue seal has been previously completed (within a predefined threshold), the use is categorized in use profile “D.”

Where it is further determined that the jaw member is partially open, e.g., not fully closed, and that the time since the start of the activation is less than a predefined threshold and/or no prior tissue seals have been completed (within a predefined threshold), the use is categorized in use profile “E.” Alternatively, where it is further determined that the jaw member is partially open, e.g., not fully closed, and that the time since the start of the activation is longer than a predefined threshold (but within a second predefined threshold) and/or a tissue seal has been previously completed (within a predefined threshold), the use is categorized in use profile “F.”

Turning now to FIG. 8, the various use profiles “A”-“F” may correspond to different surgical tasks such as, for example: use profile “A” may correspond to otomy formation and/or spot coagulation; use profile “B” may correspond to backscoring, otomy formation and/or dissection; use profile “C” may correspond to sealing relatively small diameter tissue; use profile “D” may correspond to transecting (previously sealed) relatively small diameter tissue; use profile “E” may correspond to sealing relatively large diameter tissue; and/or use profile “F” may correspond to transecting (previously sealed) relatively large diameter tissue.

In aspects, e.g., robotic or other at least partially-automated aspects, rather than determining the use profile based on a plurality of factors, e.g., clamp lever position, activation state, jaw member position, and temporal relation, the user may input an intended surgical task and the instrument or system may achieve the conditions, e.g., the clamp lever position (or corresponding position in aspects where a manual clamp lever is not utilized), activation state, jaw member position, and temporal considerations, for the use profile associated with that surgical task. The corresponding energy settings, as detailed below, may then be implemented. In other aspects, e.g., with respect to manual instruments or systems, instructions, recommendations, and/or warnings on how to operate the surgical instrument or system may be provided based on the conditions for a use profile associated with a user-input surgical task.

Referring to FIG. 9, as noted above, the use profile determined or selected may inform the energy modality(s) implemented. That is, upon an activation, once a use profile is determined, the appropriate energy modality(s) corresponding to that use profile is automatically initiated, e.g., to achieve the surgical task(s) associated with that use profile. For example, with respect to use profile “A,” e.g., to facilitate performing an otomy and/or for spot coagulation, and/or use profile “B,” e.g., to facilitate backscoring, otomy formation and/or dissection, bipolar energy may remain off while monopolar energy and ultrasonic energy are activated. With respect to use profile “C,” e.g., for sealing relatively small diameter tissue, and, subsequently, use profile “D,” for transecting (previously sealed) relatively small diameter tissue, bipolar energy and ultrasonic energy may be activated while monopolar energy is turned off. Use profile “E” may command bipolar energy only while monopolar and ultrasonic energy remain off, e.g., to facilitate sealing relatively large diameter tissue. Transecting (previously sealed) relatively large diameter tissue or otherwise operating with use profile “F,” may command both bipolar energy and ultrasonic energy while monopolar energy is turned off.

With reference to FIG. 10, in addition to the use of a specific energy modality(s) for the various use profiles, specific energy levels, e.g., for the monopolar and ultrasonic energies, where activated, may also be automatically implemented upon activation and determination of a use profile. For example, with respect to use profile “A,” where bipolar energy is off and monopolar and ultrasonic energy are activated, the monopolar energy may be activated in a coagulation mode and the ultrasonic energy may be activated in a low power mode. In use profile “B,” where bipolar energy is off and monopolar and ultrasonic energy are activated, the monopolar energy may be activated in a cut mode and the ultrasonic energy may be activated in a high power mode. With respect to use profile “C,” where bipolar energy and ultrasonic energy are activated while monopolar energy is turned off, the ultrasonic energy may be activated in a low power mode. In use profile “D,” where bipolar energy and ultrasonic energy are activated while monopolar energy is turned off, the ultrasonic energy may be activated in a high power mode. Use profile “E” involves the activation of bipolar energy only. With respect to use profile “F,” which utilizes both bipolar energy and ultrasonic energy while monopolar energy is turned off, the ultrasonic energy may be activated in a high power mode. In aspects, use profiles “D” and “F” may be merged into a single use profile corresponding to the transection of (previously sealed) tissue, regardless of the size of the tissue to be transected.

Although exemplary use profiles are detailed above, it is contemplated that any additional or alternative use profiles may be provided and determined based on the above/and or different information, e.g., using impedance feedback to determine a use profile. In aspects, machine learning may be implemented to determine, e.g., using the above information, impedance feedback, and/or any other available data from the instrument or other instruments, in order to determine a use profile. Machine learning may also be utilized to determine appropriate energy-delivery settings for each use profile.

While several aspects of the disclosure have been detailed above and are shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description and accompanying drawings should not be construed as limiting, but merely as exemplifications of particular aspects. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims

1. A surgical system, comprising: a surgical instrument having an end effector assembly, including: an ultrasonic blade operably coupled to an ultrasonic transducer for receiving ultrasonic energy produced by the ultrasonic transducer; anda jaw member pivotable relative to the ultrasonic blade between an open position and a closed position for clamping tissue between the ultrasonic blade and the jaw member,wherein the end effector assembly is configured to be activated in an ultrasonic state wherein ultrasonic energy is transmitted to tissue via the ultrasonic blade, in a bipolar state wherein electrosurgical energy is conducted between the ultrasonic blade and the jaw member and through tissue disposed therebetween, and in a monopolar state wherein electrosurgical energy is conducted from at least one of the ultrasonic blade or the jaw member to tissue and is returned via a remote return device; anda processor configured to determine a use profile of the surgical instrument upon activation of the surgical instrument and, based on the determined use profile, to initiate at least one of the ultrasonic state, the bipolar state, or the monopolar state.

2. The surgical system according to claim 1, wherein: in at least one first use profile, the ultrasonic state and the bipolar state are initiated and the monopolar state is not initiated; andin at least one second use profile, the ultrasonic state and the monopolar state are initiated and the bipolar state is not initiated.

3. The surgical system according to claim 2, wherein, in at least one third use profile, the bipolar state is initiated and the ultrasonic state and the monopolar state are not initiated.

4. The surgical system according to claim 1, wherein: in at least one first use profile where at least the ultrasonic state is initiated, the ultrasonic energy is supplied in a low power mode; andin at least one second use profile where at least the ultrasonic state is initiated, the ultrasonic energy is supplied in a high power mode.

5. The surgical system according to claim 1, wherein: in at least one first use profile where at least the monopolar state is initiated, the monopolar energy is supplied in a coag mode; andin at least one second use profile where at least the monopolar state is initiated, the monopolar energy is supplied in a cut mode.

6. The surgical system according to claim 1, wherein the processor is configured to determine the use profile based on at least two of: a position of an actuator, a position of the jaw member, a position of an activation button, a temporal relation to a prior activation, or field conditions.

7. The surgical system according to claim 1, wherein the processor is configured to determine the use profile based on at least three of: a position of an actuator, a position of the jaw member, a position of an activation button, temporal considerations, or field conditions.

8. The surgical system according to claim 1, wherein the processor is configured to determine the use profile based on: a position of an actuator, a position of the jaw member, a position of an activation button, and temporal considerations.

9. The surgical system according to claim 1, wherein the processor is configured to determine the use profile based on: a position of an actuator, a position of the jaw member, a position of an activation button, and field conditions.

10. A surgical system, comprising: a surgical instrument having an end effector assembly configured to be activated in an ultrasonic state wherein ultrasonic energy is transmitted from the end effector assembly to tissue, in a bipolar state wherein electrosurgical energy is conducted between different portions of the end effector assembly and through tissue disposed therebetween, and in a monopolar state wherein electrosurgical energy is conducted from the end effector assembly to tissue and is returned via a remote return device; anda processor configured to determine a use profile of the surgical instrument upon activation of the surgical instrument and, based on the determined use profile, to initiate at least one of the ultrasonic state, the bipolar state, or the monopolar state.

11. The surgical system according to claim 10, wherein: in at least one first use profile, the ultrasonic state and the bipolar state are initiated and the monopolar state is not initiated; andin at least one second use profile, the ultrasonic state and the monopolar state are initiated and the bipolar state is not initiated.

12. The surgical system according to claim 11, wherein, in at least one third use profile, the bipolar state is initiated and the ultrasonic state and the monopolar state are not initiated.

13. The surgical system according to claim 10, wherein: in at least one first use profile where at least the ultrasonic state is initiated, the ultrasonic energy is supplied in a low power mode; andin at least one second use profile where at least the ultrasonic state is initiated, the ultrasonic energy is supplied in a high power mode.

14. The surgical system according to claim 10, wherein: in at least one first use profile where at least the monopolar state is initiated, the monopolar energy is supplied in a coag mode; andin at least one second use profile where at least the monopolar state is initiated, the monopolar energy is supplied in a cut mode.

15. The surgical system according to claim 10, wherein the processor is configured to determine the use profile based on at least two of: a position of an actuator, a position of the jaw member, a position of an activation button, a temporal relation to a prior activation, or field conditions.

16. The surgical system according to claim 10, wherein the processor is configured to determine the use profile based on at least three of: a position of an actuator, a position of the jaw member, a position of an activation button, temporal considerations, or field conditions.

17. The surgical system according to claim 10, wherein the processor is configured to determine the use profile based on: a position of an actuator, a position of the jaw member, a position of an activation button, and temporal considerations.

18. The surgical system according to claim 10, wherein the processor is configured to determine the use profile based on: a position of an actuator, a position of the jaw member, a position of an activation button, and field conditions.