Patent Description:
Examples of ultrasonic surgical devices include the HARMONIC ACE® Ultrasonic Shears, the HARMONIC WAVE® Ultrasonic Shears, the HARMONIC FOCUS® Ultrasonic Shears, and the HARMONIC SYNERGY® Ultrasonic Blades, all by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio. Further examples of such devices and related concepts are disclosed in <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

Electrosurgical instruments utilize electrical energy for sealing tissue, and generally include a distally mounted end effector that can be configured for bipolar or monopolar operation. During bipolar operation, electrical current is provided through the tissue by active and return electrodes of the end effector. During monopolar operation, current is provided through the tissue by an active electrode of the end effector and a return electrode (e.g., a grounding pad) separately located on a patient's body. Heat generated by the current flowing through the tissue may form hemostatic seals within the tissue and/or between tissues, and thus may be particularly useful for sealing blood vessels, for example. The end effector of an electrosurgical device may also include a cutting member that is movable relative to the tissue and the electrodes to transect the tissue.

Electrical energy applied by an electrosurgical device can be transmitted to the instrument by a generator coupled with the instrument. The electrical energy may be in the form of radio frequency ("RF") energy, which is a form of electrical energy generally in the frequency range of approximately <NUM> kilohertz (kHz) to <NUM> megahertz (MHz). In use, an electrosurgical device can transmit lower frequency RF energy through tissue, which causes ionic agitation, or friction, in effect resistive heating, thereby increasing the temperature of the tissue. Because a sharp boundary is created between the affected tissue and the surrounding tissue, surgeons can operate with a high level of precision and control, without sacrificing un-targeted adjacent tissue. The low operating temperatures of RF energy may be useful for removing, shrinking, or sculpting soft tissue while simultaneously sealing blood vessels. RF energy works particularly well on connective tissue, which is primarily comprised of collagen and shrinks when contacted by heat.

An example of an RF electrosurgical device is the ENSEAL® Tissue Sealing Device by Ethicon Endo-Surgery, Inc. , of Cincinnati, Ohio. Further examples of electrosurgical devices and related concepts are disclosed in <CIT>; <CIT>; <CIT>; <CIT>;
<CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>.

Additional examples of electrosurgical devices and related concepts are disclosed in <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

Some instruments may provide ultrasonic and RF energy treatment capabilities through a single surgical device. Examples of such devices and related methods and concepts are disclosed in <CIT>; <CIT>; and <CIT>.

While various types of ultrasonic surgical instruments and electrosurgical instruments, including combination ultrasonic-electrosurgical instruments, have been made and used, it is believed that no one prior to the inventor(s) has made or used the invention described in the appended claims.

In <CIT>, there is described an apparatus comprising a body, an ultrasonic transducer assembly, a shaft assembly, and a coupling assembly.

In <CIT>, there is described a battery assembly for use with a surgical device having a battery terminal and operational parameters that include a housing having a shape formed to removably connect with the terminal.

In <CIT>, there is described an ultrasonic surgical clamp coagulator apparatus configured to effect cutting, coagulation, and clamping of tissue by cooperation of a clamping mechanism of the apparatus with an associated ultrasonic end-effector.

The invention is defined by appended independent claim <NUM>.

The following description of certain examples of the disclosure should not be used to limit the scope of the present disclosure.

Accordingly, the descriptions should be regarded as illustrative in nature and not restrictive.

For clarity of disclosure, the terms "proximal" and "distal" are defined herein relative to a surgeon, or other operator, grasping a surgical instrument having a distal surgical end effector. The term "proximal" refers to the position of an element arranged closer to the surgeon, and the term "distal" refers to the position of an element arranged closer to the surgical end effector of the surgical instrument and further away from the surgeon. Moreover, to the extent that spatial terms such as "upper," "lower," "vertical," "horizontal," or the like are used herein with reference to the drawings, it will be appreciated that such terms are used for exemplary description purposes only and are not intended to be limiting or absolute. In that regard, it will be understood that surgical instruments such as those disclosed herein may be used in a variety of orientations and positions not limited to those shown and described herein.

Hereby disclosed is an exemplary surgical system including a generator and a surgical instrument. Surgical instrument is operatively coupled with the generator via power cable. As described in greater detail below, generator is operable to power surgical instrument to deliver ultrasonic energy for cutting tissue, and electrosurgical bipolar RF energy (i.e., therapeutic levels of RF energy) for sealing tissue. In exemplary configurations, generator is configured to power surgical instrument to deliver ultrasonic energy and electrosurgical bipolar RF energy simultaneously.

Surgical instrument of the present example comprises a handle assembly, a shaft assembly extending distally from the handle assembly, and an end effector arranged at a distal end of the shaft assembly. Handle assembly comprises a body including a pistol grip and energy control buttons configured to be manipulated by a surgeon. A trigger is coupled to a lower portion of body and is pivotable toward and away from pistol grip to selectively actuate end effector, as described in greater detail below. In other suitable variations of surgical instrument, handle assembly may comprise a scissor grip configuration, for example. As described in greater detail below, an ultrasonic transducer is housed internally within and supported by body. In other configurations, ultrasonic transducer may be provided externally of body.

End effector includes an ultrasonic blade and a clamp arm configured to selectively pivot toward and away from ultrasonic blade, for clamping tissue therebetween. Ultrasonic blade is acoustically coupled with ultrasonic transducer, which is configured to drive (i.e., vibrate) ultrasonic blade at ultrasonic frequencies for cutting and/or sealing tissue positioned in contact with ultrasonic blade. Clamp arm is operatively coupled with trigger such that clamp arm is configured to pivot toward ultrasonic blade, to a closed position, in response to pivoting of trigger toward pistol grip. Further, clamp arm is configured to pivot away from ultrasonic blade, to an open position, in response to pivoting of trigger away from pistol grip. Various suitable ways in which clamp arm may be coupled with trigger will be apparent to those of ordinary skill in the art in view of the teachings provided herein. In some versions, one or more resilient members may be incorporated to bias clamp arm and/or trigger toward the open position.

A clamp pad is secured to and extends distally along a clamping side of clamp arm, facing ultrasonic blade. Clamp pad is configured to engage and clamp tissue against a corresponding tissue treatment portion of ultrasonic blade when clamp arm is actuated to its closed position. At least a clamping-side of clamp arm provides a first electrode, referred to herein as clamp arm electrode. Additionally, at least a clamping-side of ultrasonic blade provides a second electrode, referred to herein as a blade electrode. As described in greater detail below, electrodes are configured to apply electrosurgical bipolar RF energy, provided by generator, to tissue electrically coupled with electrodes. Clamp arm electrode may serve as an active electrode while blade electrode serves as a return electrode, or vice-versa. Surgical instrument may be configured to apply the electrosurgical bipolar RF energy through electrodes while vibrating ultrasonic blade at an ultrasonic frequency, before vibrating ultrasonic blade at an ultrasonic frequency, and/or after vibrating ultrasonic blade at an ultrasonic frequency.

Shaft assembly extends along a longitudinal axis and includes an outer tube, an inner tube received within outer tube, and an ultrasonic waveguide supported within inner tube. Clamp arm is coupled to distal ends of inner and outer tubes. In particular, clamp arm includes a pair of proximally extending clevis arms that receive therebetween and pivotably couple to a distal end of inner tube with a pivot pin received within through bores formed in clevis arms and distal end of inner tube. First and second clevis fingers depend downwardly from clevis arms and pivotably couple to a distal end of outer tube. Specifically, each clevis finger includes a protrusion that is rotatably received within a corresponding opening formed in a sidewall of distal end of outer tube.

In the present example, inner tube is longitudinally fixed relative to handle assembly, and outer tube is configured to translate relative to inner tube and handle assembly, along the longitudinal axis of shaft assembly. As outer tube translates distally, clamp arm pivots about pivot pin toward its open position. As outer tube translates proximally, clamp arm pivots in an opposite direction toward its closed position. A proximal end of outer tube is operatively coupled with trigger, for example via a linkage assembly, such that actuation of trigger causes translation of outer tube relative to inner tube, thereby opening or closing clamp arm. In other suitable configurations not shown herein, outer tube may be longitudinally fixed and inner tube may be configured to translate for moving clamp arm between its open and closed positions.

Shaft assembly and end effector are configured to rotate together about the longitudinal axis, relative to handle assembly. A retaining pin extends transversely through proximal portions of outer tube, inner tube, and waveguide to thereby couple these components rotationally relative to one another. In the present example, a rotation knob is provided at a proximal end portion of shaft assembly to facilitate rotation of shaft assembly, and end effector, relative to handle assembly. Rotation knob is secured rotationally to shaft assembly with retaining pin, which extends through a proximal collar of rotation knob. It will be appreciated that in other suitable configurations, rotation knob may be omitted or substituted with alternative rotational actuation structures.

Ultrasonic waveguide is acoustically coupled at its proximal end with ultrasonic transducer, for example by a threaded connection, and at its distal end with ultrasonic blade.

Ultrasonic blade is shown formed integrally with waveguide such that blade extends distally, directly from the distal end of waveguide. In this manner, waveguide acoustically couples ultrasonic transducer with ultrasonic blade, and functions to communicate ultrasonic mechanical vibrations from transducer to blade. Accordingly, ultrasonic transducer, waveguide, and ultrasonic blade together define acoustic assembly. During use, ultrasonic blade may be positioned in direct contact with tissue, with or without assistive clamping force provided by clamp arm, to impart ultrasonic vibrational energy to the tissue and thereby cut and/or seal the tissue. For example, blade may cut through tissue clamped between clamp arm and a first treatment side of blade, or blade may cut through tissue positioned in contact with an oppositely disposed second treatment side of blade, for example during a "back-cutting" movement. In some variations, waveguide may amplify the ultrasonic vibrations delivered to blade. Further, waveguide may include various features operable to control the gain of the vibrations, and/or features suitable to tune waveguide to a selected resonant frequency. Additional exemplary features of ultrasonic blade and waveguide are described in greater detail below.

Waveguide is supported within inner tube by a plurality of nodal support elements positioned along a length of waveguide. Specifically, nodal support elements are positioned longitudinally along waveguide at locations corresponding to acoustic nodes defined by the resonant ultrasonic vibrations communicated through waveguide. Nodal support elements may provide structural support to waveguide, and acoustic isolation between waveguide and inner and outer tubes of shaft assembly. In exemplary variations, nodal support elements may comprise o-rings. Waveguide is supported at its distal-most acoustic node by a nodal support element in the form of an overmold member and described in greater detail below. Waveguide is secured longitudinally and rotationally within shaft assembly by retaining pin, which passes through a transverse through-bore formed at a proximally arranged acoustic node of waveguide, such as the proximal-most acoustic node, for example.

In the present example, a distal tip of ultrasonic blade is located at a position corresponding to an anti-node associated with the resonant ultrasonic vibrations communicated through waveguide. Such a configuration enables the acoustic assembly of instrument to be tuned to a preferred resonant frequency fo when ultrasonic blade is not loaded by tissue. When ultrasonic transducer is energized by generator to transmit mechanical vibrations through waveguide to blade, distal tip of blade is caused to oscillate longitudinally in the range of approximately <NUM> to <NUM> microns peak-to-peak, for example, and in some instances in the range of approximately <NUM> to <NUM> microns, at a predetermined vibratory frequency fo of approximately <NUM>, for example. When ultrasonic blade is positioned in contact with tissue, the ultrasonic oscillation of blade may simultaneously sever the tissue and denature the proteins in adjacent tissue cells, thereby providing a coagulative effect with minimal thermal spread.

Distal end of inner tube may be offset radially outwardly relative to a remaining proximal portion of inner tube. This configuration enables pivot pin bore, which receives clamp arm pivot pin, to be spaced further away from the longitudinal axis of shaft assembly than if distal end where formed flush with the remaining proximal portion of inner tube. Advantageously, this provides increased clearance between proximal portions of clamp arm electrode and blade electrode, thereby mitigating risk of undesired "shorting" between electrodes and their corresponding active and return electrical paths, for example during back-cutting when ultrasonic blade flexes toward clamp arm and pivot pin in response to normal force exerted on blade by tissue. In other words, when ultrasonic blade is used in a back-cutting operation, ultrasonic blade may tend to deflect slightly away from the longitudinal axis of shaft assembly, toward pin. By having pivot pin bore spaced further away from the longitudinal axis than pivot pin bore otherwise would be in the absence of the radial offset provided by distal end of the present example, distal end provides additional lateral clearance between pivot pin and ultrasonic blade, thereby reducing or eliminating the risk of contact between ultrasonic blade and pivot pin when ultrasonic blade deflects laterally during back-cutting operations. In addition to preventing electrical short circuits that would otherwise result from contact between ultrasonic blade and pivot pin when end effector is activated to apply RF electrosurgical energy, the additional clearance prevents mechanical damage that might otherwise result from contact between ultrasonic blade and pivot pin when ultrasonic blade is vibrating ultrasonically.

Hereby disclosed are the additional details of overmold member. As described above, overmold member encircles waveguide at a distal-most acoustic node thereof, thereby supporting waveguide within inner tube and defining a distal-most waveguide support location. Waveguide includes an annular nodal flange at its distal-most acoustic node, and overmold member encircles nodal flange. Ultrasonic blade is integrally joined to waveguide at distal nodal flange and extends distally therefrom.

Overmold member includes a load bearing portion and an integrally formed sealing portion extending proximally from load bearing portion. As described below, each of load bearing support portion and sealing portion is configured to engage an inner surface of inner tube. Load bearing support portion includes an inner annular groove configured to receive distal nodal flange of waveguide in sealing engagement, such that load bearing support portion aligns with and encircles distal nodal flange while sealing portion extends proximally of distal nodal flange.

Load bearing support portion of overmold member includes a plurality of deforming elements spaced circumferentially about its exterior. Deforming elements define a maximum outer diameter of load bearing portion that is greater than an inner diameter of inner tube. Accordingly, deforming elements are configured to resiliently deform against the inner surface of inner tube so as to engage inner tube with an interference fit. Circumferential spacing between deforming elements enables elements to deform in a circumferential direction along the inner surface of inner tube. In this manner, load bearing support portion is configured to support waveguide in coaxial alignment with the longitudinal axis of shaft assembly, and mitigate radial displacement of distal nodal flange relative to the longitudinal axis when waveguide is driven with ultrasonic energy, as described above. Advantageously, this prevents unwanted direct contact between ultrasonic blade and clamp arm, or clamp arm pivot pin, which could otherwise cause mechanical failure of blade and/or electrical shorting of an RF electrical circuit of surgical instrument. Overmold member may be formed of any material or combination of materials suitable to acoustically isolate distal nodal flange relative to inner tube. For instance, at least deforming elements and sealing portion may be formed of a resiliently deformable polymeric material, such as silicone, for example.

Each deforming element is shown in the form of a rounded protrusion, or bump, integrally formed with load bearing support portion and projecting radially outwardly from an outer surface thereof, and extending axially. Load bearing support portion includes four deforming elements arranged with uniform circumferential spacing. In other configurations, any suitable quantity and circumferential spacing of deforming elements may be provided. A distal end of load bearing support portion may taper from deforming elements toward ultrasonic blade.

Sealing portion of overmold member is spaced proximally from load bearing support portion by an outer annular groove. Sealing portion includes an annular outer sealing edge configured as a wiper seal that resiliently deforms against, and thereby establishes a liquid-tight seal with, a full inner circumference of the inner surface of inner tube. As shown, an axial dimension of sealing edge is substantially less than an axial dimension of deforming elements. Accordingly, while deforming elements are configured to provide structural support to waveguide, sealing edge is configured to maintain a liquid-tight seal against inner tube to prevent proximal ingress of body fluids and tissue into shaft assembly along waveguide. Such ingress could yield undesirable reduction of ultrasonic energy delivery from waveguide to ultrasonic blade, and/or electrical coupling of waveguide to inner tube, which could result in shorting of the RF electrical circuit of surgical instrument. Outer sealing edge defines a maximum outer diameter of sealing portion, which may be equal to, slightly less than, or slightly greater than the maximum outer diameter of load bearing portion defined by deforming elements.

Hereby disclosed is another exemplary overmold member suitable for use with surgical instrument in place of overmold member. Overmold member is similar to overmold member described above except as otherwise described below. Similar to overmold member, overmold member encircles nodal flange at the distal-most acoustic node of waveguide to thereby support waveguide coaxially within inner tube. Unlike overmold member, an exterior of overmold member includes an annular rim that engages an inner surface of inner tube with an interference fit so as to function as both a load bearing portion and a sealing portion, similar to load bearing portion and sealing portion of overmold member described above.

Annular rim of overmold member of the present example is positioned at a medial portion of overmold member such that annular rim is aligned with distal nodal flange of waveguide. Annular rim extends continuously about a full circumference of overmold member such that rim is configured to establish a continuous seal with the inner surface of inner tube. Moreover, annular rim extends radially outwardly to define a maximum outer diameter of overmold member that provides a degree of interference with inner tube sufficient to provide both mechanical support and annular sealing about the full circumference of waveguide. In some examples, annular rim may provide a higher degree of interference with inner tube than deforming elements of overmold member. However, similar to deforming elements, at least annular rim of overmold member may be formed of a resiliently deformable polymeric material, such as silicone, for example. Though not shown, overmold member may include one or more additional annular features arranged proximally or distally of annular rim and configured to sealingly engage the inner surface of inner tube, for instance similar to annular sealing edge described above.

Overmold member of the present example further includes a proximal tapered portion that extends proximally from annular rim, a distal tapered portion that extends distally from annular rim, and a distal flap that extends distally from a distal end of distal tapered portion. Proximal tapered portion tapers inwardly from annular rim in a proximal direction, and distal tapered portion tapers inwardly from annular rim in a distal direction. Proximal and distal tapered portions may be formed with similar axial lengths and taper angles and are configured to facilitate axial assembly of inner tube over waveguide and overmold member. Distal flap overlaps a proximal end of ultrasonic blade and is configured to create an annular seal between overmold member and the corresponding portion of waveguide and ultrasonic blade covered by distal flap. It will be appreciated that various other versions of overmold member may be employed that incorporate one or more features from each of the overmold members to provide annular sealing and mechanical support about the circumference of waveguide within inner tube.

Similarly, those of ordinary skill in the art will recognize that various teachings herein may be readily combined with various teachings of any of the following: <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and/or <CIT>.

Use of such techniques, and the resulting reconditioned device, are all within the scope of the present disclosure.

Having shown and described various embodiments of the present disclosure, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present disclosure.

Claim 1:
A surgical instrument comprising:
(a) an ultrasonic transducer;
(b) a shaft extending distally relative to the ultrasonic transducer along a longitudinal shaft axis;
(c) a waveguide acoustically coupled with the ultrasonic transducer and extending distally through the shaft, wherein the waveguide includes an annular nodal flange at the distal-most acoustic node;
(d) an end effector arranged at a distal end of the shaft, wherein the end effector includes an ultrasonic blade acoustically coupled with the waveguide, wherein the ultrasonic blade integrally joins with the waveguide at the nodal flange, wherein the ultrasonic transducer is operable to drive the waveguide and the ultrasonic blade with ultrasonic energy; and
(e) a nodal support element positioned to support a nodal portion of the waveguide within the shaft, wherein the nodal support element includes a plurality of deformable elements configured to deform against an inner surface of the shaft, and the deformable elements are arranged with uniform circumferential spacing, and wherein an interior of the nodal support element includes an annular groove configured to receive the nodal flange in sealing engagement, such that the nodal support element aligns with and encircles the distal-nodal flange.