# Patent

## Title
Method for manufacturing an electrode assembly configured for use with an electrosurigcal instrument

## Abstract

A method for manufacturing an electrode configuration configured for use with an electrosurgical instrument is provided. A pre-assembled jaw configuration including jaw members including respective first and second electrodes is provided. One or more stop members are positioned on the first electrode. The first and second electrodes are approximated toward one another for contact therebetween so as to form an at least one indentation on the second electrode.

## Background
CROSS REFERENCE TO RELATED APPLICATION
The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/766,563, filed on Feb. 19, 2013, the entire contents of which are incorporated herein by reference.


BACKGROUND
Technical Field
The present disclosure relates to a method for manufacturing an electrode assembly configured for use with an electrosurgical instrument. More particularly, the present disclosure relates to a method for manufacturing an electrode assembly including a self-setting electrode configuration.
Description of Related Art
Electrosurgical instruments configured to electrosurgically treat tissue are well known in the art. Typically, the electrosurgical instrument includes a housing, shaft, and an end effector including a pair of jaw members. One or more suitable electrosurgical energy sources may be utilized to provide electrosurgical energy to the jaw members of the end effector. Depending on the electrical configuration of the jaw members, one or both of the jaw members will include an electrode configuration that is configured to supply current thereto for electrosurgically treating, e.g., coagulate, seal, fulgurate, desiccate, etc., tissue.
In certain instances, such as, for example, during a tissue sealing procedure, a precise, well maintained gap between opposing electrodes is required to ensure proper vessel sealing and grasping functions. This gap, which is commonly referred to in the art as “jaw gap,” is a function of the individual components as well as the final device assembly process. Variation in these areas may lead to overall variation in “jaw gap” that may result in degradation of performance.
SUMMARY
As can be appreciated, a method for manufacturing an electrode assembly including a self-setting electrode configuration may prove useful in the surgical arena.
Embodiments of the present disclosure are described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. As used herein, the term “distal” refers to the portion that is being described which is further from a user, while the term “proximal” refers to the portion that is being described which is closer to a user.
An aspect of the present disclosure provides a method for manufacturing an electrode configuration for an electrosurgical instrument. A jaw configuration including first and second jaw members including respective first and second electrodes thereon is provided. One or more stop members are positioned on the first electrode. The first and second jaw members including the electrodes are approximated toward one another for contact therebetween. And, one or more indentations are formed on the second electrode. The indentation(s) may be configured to provide a jaw gap that ranges from about 0.001 inches to about 0.006 inches. Moreover, during in-situ use of the pre-assembled jaw members, engagement between the at least one stop member and the at least one indentation is configured to prevent jaw splay.
Approximating the first and second jaw members including the electrodes may include compressing the first and second jaw members with a force that is at least twice as much as a force that is utilized to electrosurgically treat tissue in situ. Positioning the stop member(s) may include providing a stop member that is a ceramic dot.
A shim may be provided between the first and second opposing electrodes prior to approximating the first and second jaw members including the electrodes toward one another so as to control a depth of the at least one indentation. A portion of a bottom surface of the second electrode may be removed to facilitate forming the at least one indentation. The portion of the bottom surface may be located directly beneath the position of where the at least one indentation is to be formed. An etching process may be utilized to remove the portion of a bottom surface of the second electrode. Alternatively, a portion of a bottom surface of the second electrode may be chemically treated to facilitate forming the at least one indentation; the portion of the bottom surface is located directly beneath chemically.
An aspect of the present disclosure provides a method for manufacturing an electrode configuration for an electrosurgical instrument. A pre-assembled jaw configuration including first and second jaw members including respective first and second electrodes is provided. One or more stop members are positioned on the first electrode. A portion of a bottom surface of the second electrode is configured to deform when a predetermined force is applied thereto. The first and second jaw members including the electrodes are approximated toward one another for contact therebetween. And, one or more indentations are formed on the second electrode. The indentation(s) may be configured to provide a jaw gap that ranges from about 0.001 inches to about 0.006 inches. Moreover, during in-situ use of the pre-assembled jaw members, engagement between the at least one stop member and the at least one indentation is configured to prevent jaw splay.
Approximating the first and second jaw members including the electrodes may include compressing the first and second jaw members with a force that is at least twice as much as a force that is utilized to electrosurgically treat tissue in situ. Positioning the stop member(s) may include providing a stop member that is a ceramic dot.
A shim may be provided between the first and second opposing electrodes prior to approximating the first and second jaw members including the electrodes toward one another so as to control a depth of the at least one indentation. A portion of a bottom surface of the second electrode may be removed to facilitate forming the at least one indentation. The portion of the bottom surface may be located directly beneath the position of where the at least one indentation is to be formed. An etching process may be utilized to remove the portion of a bottom surface of the second electrode. Alternatively, a portion of a bottom surface of the second electrode may be chemically treated to facilitate forming the at least one indentation. The portion of the bottom surface may be located directly beneath the position of where the at least one indentation is to be formed.
An aspect of the present disclosure provides a method for manufacturing an electrode configuration for an electrosurgical instrument. A pre-assembled jaw configuration including first and second jaw members including respective first and second electrodes is provided. One or more stop members are positioned on the first electrode. A portion of a bottom surface of the second electrode is configured to deform when a predetermined force is applied thereto. A shim may be provided between the first and second opposing electrodes. The first and second jaw members including the electrodes are approximated toward one another for contact therebetween. And, one or more indentations are formed on the second electrode. The indentation(s) may be configured to provide a jaw gap that ranges from about 0.001 inches to about 0.006 inches. The shim may be provided between the first and second opposing electrodes prior to approximating the first and second jaw members including the electrodes toward one another so as to control a depth of the at least one indentation.



BRIEF DESCRIPTION OF THE DRAWING
Various embodiments of the present disclosure are described hereinbelow with references to the drawings, wherein:
FIG. 1 is a perspective view of an electrosurgical instrument configured for use with an end effector including jaw members having electrodes manufactured in accordance with an embodiment of the instant disclosure;
FIG. 2A is a schematic, side view of a pair of pre-assembled jaw members positioned in a pre-approximated configuration during a manufacturing process;
FIG. 2B is a schematic, side view of the pair of pre-assembled jaw members positioned in an approximated configuration during a manufacturing process;
FIG. 3 is a top, plan view of the pre-assembled jaw members subsequent to formation of an indent on an electrode of one of the jaw members; and
FIG. 4 is a flow-chart illustrating a method for manufacturing the jaw members.



DETAILED DESCRIPTION
Detailed embodiments of the present disclosure are disclosed herein; however, the disclosed embodiments are merely examples of the disclosure, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
FIG. 1 shows an electrosurgical forceps 4 configured for use with jaw members 26, 28 including electrodes 30, 32 formed via a method of manufacture according to an embodiment of the instant disclosure. Briefly, forceps 4 generally includes a housing 6, a shaft 16, a handle assembly 8, a rotating assembly 10 and a trigger assembly 12, which mutually cooperate with an end effector assembly 14 to grasp and treat tissue. Shaft 16 includes a distal end 18 that mechanically engages end effector assembly 14 and a proximal end 20 that mechanically engages housing 6 proximate the rotating assembly 10. Handle assembly 8 includes a fixed handle 22 and a movable handle 24. End effector assembly 14 includes jaw members 26, 28 that are movable from a first position wherein the jaw members 26, 28 are spaced relative to one another to a closed position wherein the jaw members 26 and 28 cooperate to grasp tissue therebetween. Each of the jaw members 26, 28 includes an electrically conductive tissue treatment surface 30, 32, e.g., electrodes 30, 32, that is connected to an energy source (e.g., a generator not explicitly shown) that communicates electrosurgical energy, e.g., RF energy, through tissue held between jaw members 26, 28.
With reference to FIGS. 2A-4, a method 100 utilized to manufacture jaw members 26, 28 is illustrated. In accordance with the instant disclosure, jaw members 26, 28 may, initially, be provided in a pre-assembled configuration (see FIG. 4 at step 102). Specifically, jaw members 26, 28 are manufactured with jaw housings 26a, 28a, respectively, that have been formed via one or more suitable manufacturing methods. In the illustrated embodiment, for example, jaw housings 26a, 28a are formed with respective electrodes 30, 32 coupled thereto via an overmolding process to form jaw members 26, 28.
In accordance with the instant disclosure, one or both of electrodes 30, 32 may be formed with an indention 40 and/or a stop member 42 (see FIGS. 2A-3 for example). For illustrative purposes, electrode 30 is formed with stop members 42 (see FIG. 4 at step 104) and electrode 32 is formed with indentations 40.
Stop members 42 may be formed or coupled to electrode 30 via any suitable forming or coupling methods. For example, in the illustrated embodiment stop members 42 are in the form of ceramic dots that have been affixed to a tissue contacting surface of electrode 30 via one or more suitable adhesives. Stop members 42 are configured to contact electrode 32 so as to provide a specific gap distance between jaw members 26, 28 when the jaw members 26, 28 are in a clamping configuration, see FIG. 2B for example. In accordance with the instant disclosure, a suitable gap distance between jaw members 26, 28 may range from about 0.001 inches to about 0.006 inches. In certain embodiments, the gap distance may be about 0.003 inches.
Additionally, stop members 42 are configured to contact a tissue contacting surface of electrode 32 so as to form a corresponding indentation 40 thereon. Specifically, during a manufacturing process of jaw members 26, 28, jaw members 26, 28 are approximated toward one another and compressed under a suitable compressive force so that stop members 42 contact the tissue contacting surface of electrode 32 and form a corresponding indentation thereon (see FIG. 4 at step 106), i.e., jaw members 26, 28 are “over pressurized” to form the indentation. In accordance with the instant disclosure, it has been found that a suitable compressive force to indent the opposing electrode 32 when no tissue is present would be about 6 kg/cm2 to about 32 kg/cm2 or about twice the normal compressive force that would be utilized to seal tissue.
In embodiments, one or more shims 44 formed from any suitable material, e.g., ceramic, may be placed between electrodes 30, 32 prior to approximating the jaw members 26, 28 including electrodes 30, 32 toward one another so as to control a depth of indentation 40. Shim(s) 44 include a height that is approximately equal to a desired gap distance. In the illustrated embodiment for example, shim(s) 44 include a height that ranges from about 0.001 inches to about 0.006 inches. In certain embodiments, the height of shim(s) 44 may be about 0.003 inches.
In embodiments, prior to the overmolding process, electrodes 30, 32 may be chemically or otherwise treated. Specifically, a portion 46 of a bottom surface electrode 32 may be removed to facilitate forming indentations 40 on electrode 32. For example, in one particular embodiment, an etching process may be utilized to remove portion 46 of a bottom surface of one of the jaw members, e.g., jaw member 28. Alternatively, a portion 46 of the bottom surface of electrode 32 may be chemically treated with one or more suitable chemicals, e.g., acid, to remove portion 46 from electrode 32. In either embodiment, portion 46 is located directly beneath a position of where indentation 40 is to be formed on electrode 32, see FIGS. 2A-2B.
Method 100 may be carried out in the following manner. A pre-assembled jaw configuration including jaw members 26, 28 including respective electrodes 30, 32 thereon may be provided (see FIG. 4 at step 102). Stop member(s) 42 may be positioned on electrode 30 via one or more of the aforementioned affixation methods (see FIG. 4 at step 104). In embodiments, shim(s) 44 may also be positioned between electrodes 30, 32 prior to approximating jaw members 26, 28 including electrodes 30, 32 towards one another. Jaw members 26, 28 including electrodes 30, 32 are approximated toward one another so as to form corresponding indentation(s) 40 on electrode 32.
As noted above, during in-situ use of jaw members 26, 28, indentation(s) 40 may be configured to provide gap distance that ranges from about 0.001 inches to about 0.006 inches when jaw members 26, 28 are in a clamping configuration. Specifically, when tissue is to be sealed, stop member(s) 42 engage indentation(s) 40 to provide a specific gap distance between electrodes 30, 32. Moreover, a ratchet mechanism or other suitable device (not explicitly shown) may be provided on forceps 4 and may be configured to maintain a specific compressive force on tissue when tissue is clamped between jaw members 26, 28. The compressive force applied to tissue may range from about 3 kg/cm2 to about 16 kg/cm2 or about half of the compressive force that is utilized to form indentation(s) 40 on electrode 32. Further, one or more controllers or control algorithms (not explicitly shown) may be operably coupled to the forceps 4 (or provided in the generator) to control the amount of electrosurgical energy that is provided to electrodes 30, 32. All of these three factors may contribute in providing an effective, uniform and consistent tissue seal.
In accordance with the instant disclosure, the unique method 100 of manufacture of electrodes 40, 42 eliminates the aforementioned variations by incorporating self-setting features therein to precisely set a given jaw gap between the jaw members 26, 28.
Moreover, during in-situ use of jaw members 26, 28, engagement between stop member(s) 42 and indentation(s) 40 is configured to prevent jaw splay of jaw members 26, 28.
From the foregoing and with reference to the various figure drawings, those skilled in the art will appreciate that certain modifications can also be made to the present disclosure without departing from the scope of the same. For example, while the aforementioned electrodes 30, 32 have been formed via method 100 and configured for use with an endoscopic electrosurgical instrument 4, electrodes 30, 32 may be formed via method 100 and configured for use with an open type electrosurgical forceps, e.g., scissor type forceps.
While several embodiments of the disclosure have been 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 should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

## Claims

1. A method for manufacturing an electrode configuration for an electrosurgical instrument, comprising:
providing first and second jaw members including respective first and second electrodes, the first electrode having at least one stop member;
removing at least a portion of a bottom surface of the second electrode to form a cavity therein;
approximating the first and second jaw members including the first and second electrodes toward one another; and
contacting the at least one stop member of the first electrode with a portion of a tissue-contacting surface of the second electrode to deform the portion of the tissue-contacting surface into the cavity in the bottom surface of the electrode to form at least one indentation on the second electrode.

2. The method according to claim 1, wherein approximating includes compressing the first and second jaw members with a compressive force that ranges from about 6 kg/cm2 to about 32 kg/cm2.

3. The method according to claim 1, wherein the at least one stop member is a ceramic dot.

4. The method according to claim 1, further comprising positioning a shim between the first and second electrodes prior to approximating the first and second jaw members including the first and second electrodes toward one another so as to control a depth of the at least one indentation.

5. The method according to claim 1, wherein the tissue-contacting surface and the bottom surface of the second electrode are disposed on opposite sides of the second electrode such that the cavity in the bottom surface of the second electrode and the at least one indentation formed on the tissue-contacting surface of the second electrode overlap one another.

6. The method according to claim 1, wherein the cavity is formed by chemically treating the portion of the bottom surface of the second electrode.

7. The method according to claim 1, wherein the at least one indentation is configured to provide a jaw gap that ranges from about 0.001 inches to about 0.006 inches.