CA2134899A1 - Bipolar surgical snare and methods of use - Google Patents

Bipolar surgical snare and methods of use

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Publication number
CA2134899A1
CA2134899A1 CA002134899A CA2134899A CA2134899A1 CA 2134899 A1 CA2134899 A1 CA 2134899A1 CA 002134899 A CA002134899 A CA 002134899A CA 2134899 A CA2134899 A CA 2134899A CA 2134899 A1 CA2134899 A1 CA 2134899A1
Authority
CA
Canada
Prior art keywords
electrodes
instrument
loop
support shaft
strand
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA002134899A
Other languages
French (fr)
Inventor
Philip E. Eggers
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Vital Medical Products Corp
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2134899A1 publication Critical patent/CA2134899A1/en
Abandoned legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206Generators therefor
    • A61B18/1233Generators therefor with circuits for assuring patient safety
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1402Probes for open surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/0091Handpieces of the surgical instrument or device
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206Generators therefor
    • A61B2018/1246Generators therefor characterised by the output polarity
    • A61B2018/1253Generators therefor characterised by the output polarity monopolar
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206Generators therefor
    • A61B2018/1246Generators therefor characterised by the output polarity
    • A61B2018/126Generators therefor characterised by the output polarity bipolar
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1405Electrodes having a specific shape
    • A61B2018/1407Loop
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1405Electrodes having a specific shape
    • A61B2018/1407Loop
    • A61B2018/141Snare
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/1815Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
    • A61B2018/1861Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves with an instrument inserted into a body lumen or cavity, e.g. a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/007Aspiration
    • A61B2218/008Aspiration for smoke evacuation

Abstract

A bipolar snare instrument (10) for use in surgery is provided.
The snare instrument (10) has a snaring loop (12) comprising a flexible continuous electrically-insulating loop (20) to provide localized selected necrosis and hemostasis of a patient's protruding tissue. Methods of performing surgery with such devices are also described.

Description

'V093/21845 PCT/US93/0q06~
213~899 BIPO~R SURGICAL SNARE AND METHQDS OF US~E
This invention relates to ~nares for use in surgery. ~ore particularly, ~his invention relates to a bipolar surgical snare, and me~hods of using such ~nares.
: : :
Bac~o~Dd nr The nvention : Bipolar ~urgical snare instruments for rem~ving protrud~ing tissue, such a~ tonsils, polyps and the~like, ~re~well known. For example, U.S. Patent Nos. 4,493,~320,~5,~026?371 and 5,078,716 ~ach d~scribe a polar snare~instrument that includes a pair o~
opposing~lexible electrically conducting uninsulated sna~e~wires~connec~ed by an electrically~insulating c~nnector:to~form a:snaring loopO The oppo~ing snare lS~ wire~form~the~ bipolar electrodes o~ the ins rument.
~ The~electrically-insulating conne~tor isolates~ the oppo~ing~ nare~wires o that a~:alternatin~:e~ctric potential~ can;~be~applied across the~electrodes of the snare loo~
20 :: ~ Each o~ the abo~e-described bipolar snàre instruments,:~suffers from one o~ more draw~acks associated~witb the use of the:~lectrically-insulating connector ~o isolate the ends of the opposing snare wires.~ Assembling the ends of the o~posing~snare wires :25 wit~ the electr~cally insulating connec~or adds to the : complexity of the manufacturing:process, -cince the ~ ::~ :

W093/2l~5 2 1 3 4 8 9 9 PC~/US91/~1~6 ~

connector must be made of an electrically-insulating material such as a plastic, ceramic, glass or epoxy-based material.
The electrically-insulating connector mu t form a sufficiently strong bond to the snare wires to support the loads generated during surgery. $his strength requirement of the connector may also add to the complexity o~ the snare design. For example, Treat U.S. Patent No. 4,493,320 describes elec~rically-~ 10 insulating connectors having V-shaped, solid ::: rectangular and circular-shaped forms, wherein the ends of the snare wires are imbedded in the connectorO
If the bond between snare wires and the insulating connector is not capable of su~porting the tensile stre~sses evol~ed during actuation ~ the : : snaring loop, the instrument may malfun~tion du~ing surgery. In an extreme case~ the connector may become : detached from bo~h snar~ wires and thus detach from the : snaring ins~rument altogether. In endoscopic surgery, 20 ~such a malfunction may have serious consequences, as it may be ex~remely diffi~ult to remotely retrieve the detached:~aonnector. Additionally, should detachment of he connector go unnoticed until after surgery has been completed, ~he patient may reguire additional
2;5 ~treatment.
further drawback of pre~iously known :bipolar snare~instrumsnts is the need to uni~ormly wi~hdraw and extend the opposing snare wires when :: operatiny the instrument. For effective selective 30 :necrosis and hemostasis of tissue, it: is desirable that thP lPnqths:~of the bipolar electrodes~be egual throughout the range of actua~ion of the instrument.
Some previously known bipolar snares permit the snare : wires forming the elec~rode to ~e withdrawn ~ 35 preferentially from side-to-side or cocked, so that the :;

~: :

`~093/21~ - 2 1 3 ~ ~ 9 9 P~T/~S93/Oq~5 lengths of th~ exposed electrodes become unaqual.
Consequently, the selective necrosis and hemostasis a hieved in such cases may be less than that desired to acc~mplish the objective of the surgery.
In light of the above, it would be desirable to provide an improved bipolar snare instrument for use in surgery that overcomes the drawbacXs of previously known snares~
~ It would also be desirable to pro~ide a snare : 10 ins~rument for use in surgery that does not have the ~:; design and manufacturing complexity associated with the electrically-insulating connector of pre~iously known bipolar snare instruments.
It would further be desirable to provide a snare instru~ent for use in surgery that reduces the likelihood that a component of the instrument will be de~osit~d in~the internal tissue reigions of a patient during surg~ry:should a malfunctio~ o cur.
It ~ould still furthe~ be desirable to provide a~bipolar snare instrument that promotes effective selective necrosis and hemostasis of tissue by providing:~uniformly equal lengths of bipolar electrodes~during all phases of operation, and which reduces the~potential for ineffec~ive necrosis and 5~ hemostasis;~aaused ~by preferential cocking of the opposing~snare wires.

Summarv:Of The~ r~ ion ~: : In view of the foregoing, i is an object of s ~ the present invention to provide an improved bipolar snare ins~rument for use in surgery that overcomes the drawbacks of previously known snares.
It is another object of the present inventiun to provide a snare instrument for use in surgery that ~; does not have the design and manufacturing complexity `~:

WO 93/21845 2 13 4 8 9 9 PCr/1)593/0406~r~

associated with the electrically-insulating connector of pre~iously known bipolar snare instruments.
It iS a further object of this invention to ~rovide a snare instrument for use in surgery that reduces the likelihood that a component will be deposited in the internal tissue regions of a patient : during ~urgery if a malfunction occurs.
: . It is a still further object of this : invention to provide a bipolar snare instrument that promotes effective selective necrosis and hemostasis of tissue by providing bipolar electrodes of equal length : during all phases of operation of the instrum~nt.
: In accordance with the present invention,there is provided a bipolar surgical snare instrument 15~ having a fl~xible snarinq loop comprising a strand of ;; continuous electrically-insulating material. First and econd electrodes are disposed:on the loop of electricial:ly insulating material to form the bipolar elèctrodes of the instrument.
0::~ The: snare instrument further comprises a sùpport ~haft having proximal and distal ends, with the snarinq loop~disposed from the distal end and actuatvr means disposed~from the proximal end:~or manipulating the:~inarlng~:loop.~
25 ~ he:~insulating loop~;and first and~second ;electrodes::of~the present învention;may be~configured so that the~;first~;~and second elec~rodes~are~disposed on opposing portions of the~insulating loop. In an : alternative~embodiment, the ~irst and second~electrodes 30~ extend cont~inuously along upper;and~ ower portions of ; the insulating:loop to define an~:electrically-isolating gap therebe~ween~
. In addition to providing a bipolar snare : instrument, the pres~nt invention~further includes methods of performing surgery on~a pa:~ient's protruding : , ~

, , :~;.::
~: :

'~0 93~21845 PCr/US93/~406~
~l3~9~

tissue using an instrument having a support shaft with a distal end and a proximal end, a snaring loop with first and second electrodes dispos~d from the distal end of the support shaft, and actuator means disposed from the proximal end of the support shaft for manipulating the instrument and varying the circumference of the snaring loop, the methods : comprising the steps of:
(a) connecting the first and secund : 10 electrodes of the bipolar snare instrumen~ to a power source for supplying AC electrical power to the instrument;
(b) creating an openin~ in a patient's body cavity or using a natural body orifice to provide access to the patient's tissuP;
(c) inserting the working surface and support shaft of the instrument through the access :opening so that the snaring loop i~ di~posed adjacent t~ thP pa~ient's protruding tissue;
(d) selecting and maintaining a substantially constant voltage level output across the power source, the voltage level output independent of the impedance:of the load connected across the power ;source; ~ ~
25 ~ e) placing the snaring loop around protruding tissue;
, ~
(f) operating the actuator means to reduce the Gircumference of the snaring loop so that the bipolar electrodes contact the protruding tissue;
30 and (g) activating the bipolar electrodes so that an alternating current is conducted between the electrodes and the protruding tissue to cause selective necrosis and hemostasis of the tissue.

` ` - 213 4 ~ 9 9 IP~lu$ 3 ~NOY 1993 Brief DescriPtion Of The Drawinqs The above and other objects and advantages of the present invention will be apparent upon consideration of ~he following detailed description, taken in conjunction with accompanying drawings, in which like reference characters refer to like parts throughout, and in which:
FIG. 1 is a perspective view of bipolar ;~ ~ surgical s:nare apparatus constructed in accordance with the principles of the present invention;
FIG. 2 is a detailed perspectlve view, partly section, of the working end of the bipolar surgical snare of FIG. 1;
FIG. 3A is a cross-sectional view of the !
snaring loop of the present invention, taken along line 3-3 of FIG. 2, howing a protruding tissue dispos~d within:the snare;
FIGS. 3B and:3C are views, similar to FIG. 3A
show~ing the snarin~g loop of FIG. 3A as it is closed 2~0~ upon the tissue, : FIG. 4::is~a detailed perspective view of a worklng end~ of ~an~ alternative embodiment of the snaring loop of the~presen~invention;
: FIG~.~5~is:a perspective cross-sectional view ::25~ o~ ;the~snaring loop of FIG. 4, taken along line 5-5 of FIG.~6~i:s a~fragmentary:;side~view, taken along line 6-~6:~of FIG. 5, showing:the snaring loop:
positionqd~around~protruding tissue;
:30 FIG. ~7:is a detailed perspective view of a working end of an alternative embodiment of the snaring loop of:the present invention; and : ~:
SVBSTITUIE SHEE~
: IPE~US
:::

.. . . .... = . ~ .. , ~ ., ~ . , .~ ~93/2184~ 2 1 ~ 4 ~ 9 9 PCT/~S93/040~

FIG. 8 is a perspective cross-sectional ~i~w of the snaring loop of FI~. 7, taken along line 8-8 of FIG. 7.

Detailed De~cr_E~i5~LC~_The Invention Reiferring to FIGS. 1-3, a f irst embodiment of snaring instrument lO of the pre~ent inventio~ is . described. S~aring instrument lO is used to severe pro~ruding tissue, such as polyps or the like, and to ~: . provide localized heating to such tissues to cause selective necrosis and hemostasis. Snaring instrument lO includes~support shaft ll having proximal and distal ~: ~ ends~ Support shaf~ ll may be either flexible or rigid, depending upon the intended application o~ the naring instrument. A working end comprising snaring loop 12 projec~s ~rom the distal end of support shaft ll, while~snare actuator 13 ~or facilitating : manipulation of the instrument and ac uation of the snaring loop is disposed from the proximal end of support shaft l~ Snaring loop 12 includes fir~t and 20 ~second electrodes, 14 and l5,~respectively, for providing~:~bipolar cauterization~ El ctrical leads 16 are~connected at one end to power source 17 (through electrical~;~connectors~l8a and 18b, r spectively) and at the other~:end,~:thr~ugh sn re actuator 13, to elactrodes 25~ 14 and l5,~ re~pectively.
eferring:particular1y to FIGS. 3A-3C, the opèration ;of snaring instrument~lO is~described. S~are actuator 13 is used ts manipulate the working end of instrument 10 so that snaring~loop~l2 is positioned around protruding tissue lO0, or other similar tissue (see FIG. 3A). The circumference 12a of snaring laop 12 ~ay then be reduced using actuator 13 so that snaring loop 12 contacts protruding tissue lO0 ~see ~
FIG. 3B). After contacting the tissue the , ~ ~

WO93/21~ 2 1 3 4 ~ ~ 9 PCT/US9310406~

circumference 12a of snaring loop 12 may be further contracted by ~ctua~or 13 so as to begin to severe protruding tissue 100. Alternatively, power supply 17 may be activated so as to supply an alternating-current (AC) voltage to electrodes 14 and 15 prior to further reduction in the cross-sectional area bounded by circumference 12a of snaring loop 120 A combination of these ~teps may also be performed, as suited for the pa~ticular surgical procedure ti.e., the snaring loop ~ 10 can be contracted while supplying an AC voltage; see : FIG. 3C).
: Power supply 17 s~pplies an alternating : current 1~ between electrodes 14 and 15 and through protruding tissue 100 (~ee FIG. 3C). This bipolar ; ~ 15 conduction process results in the localized heating of protruding tissue 100, in tissue regions adjacent ` electrodes 14 and 15. This localized heating results in elevated temperatures sufficient to cause selective : necrosis and hemostasis of the tissue. ~he bipolar : : 20 f~ature of snaring instrument 10 ensures that the : conduction of current through tissue remote from the : operative tissue is small.
:~
In accordance with the present invention, snaring loop 12 is a composite of electxically-conducting and electrically-insulating materials. As : s~own in FIG. 3, ~naring loop 12 is formed from a s~rand of electrically-insulating material having its nds connected to actuator 13 and its midsection projecting from the distal end of support shaft 11 to : : 30 form a continuous loop 20. Loop 20 may be retracted or expanded by operation of actuator 13. Electrodes 14 and 15 are positioned on the inner surface 20a of electrically-insulating loop 20 to supply an AC
~lectric potentiaI across the tissuP disposed within ~ : 35 the loop.

: ~ :

.-W093/21~5 PCT/US93/0406~
2~3~8~

g Loop 20 is formed fr~m a continuous strand of electrically-insulating flexible material suitable for carrying elec~rodes on it's working end. In particular, the material comprising loop 20 must be capable of withstanding the tensile loads imposed by operation of the instrument. Suitable materials include, for example, KAPT0~0, a polyamide material and ~YLAR~, a polyes~er material, both available from E.I.
du Pont de Nemours & Co., Inc., of Wilmington, Delaware.
. In a first embodiment of the present invention, insulating loop 20 shown in FIGS. 1-3 preferably comprises a ribbon having a width of approximately 3 mm with a thickness of approximately 1 to 2 mils ~5-50 microns). Of course, other geometries and dimensions are possible depending upon the particular material used and the intended application.
: Insulating loop 20 extends inside support : shaft 11 so that the ~nds of the loop are engaged with 20~ actuator 13 in the bore of support shaft 11.
ntermediate~connections may be disposed within the : bore of support shaft:11 to facilitate connection of actuator 13:to the proximal ends of loop 12, if ;desired. me circumference 12a of snaring loop 12 is 25~ adjusted by~rec~iprocating the proximal portions of :: loop 12 through loop holder ~1. As the loop is withdrawn into support shaft 11 through loop holder 21, tissue 100 disposed within the s~aring loop is first : contacted and then strangulated by t~e ioop. Seilective necrosis of the tissue contacting the loop, which necrosis is caused by the current passing between ; : electrodes~14 and 15 and the tissue, weakens the ti~sue and thereby permits the loop to sever the tissue.
FIG.: 1 shows only one illustrative type of ~ 35 actuator for reducing the circumference of snaring '~ ' :: :

WO93/21~5 2 1 3 4 8 9 9 PCT/US93/0406~

.

loop 12. ~owever, o~her ~ypes of actuators may be easily devised to provide the necessary action, such as pistol-and-trigger or sliding arrangem nts. The actuator need only provide for adjustment of the circumference, and thus cross-sectional area, of the snaring loop.
;~ Similarly, FIG. 1 shows only one illustrative type of support shaft for carrying the snaring loop of ~the present: in~en~ion. The carrying means should : : . 10 provide for~manipulation and contraction of thP snaring loop~ of the present invention as described heretofore.
:In ~ firs~ embodiment of the present invention, support sh~ft 11 preferably has a diameter of approximately 5 ~m so that it will fit through standard size co~.lercially-available trocar tubes. Of course, other diameters and geometrical shapes may be desired, : depending up~n the intended applica ion.
: ; : An~additional feature of the present invention is~that a portion of support shaft 11 near 20 :::the distal~end may be flexible so as to permit it's insertion with:in a patient's curved passageway.
Alternatively~,:the flexible portion may extend to the proximal: end so that ~he support:shaft may be insèrted to~a circuitous passageway, for~:example, an 25~intestinal tract. Such~a shaft allnws~snaring loop 12 to reach:remote treatment sites, e~gO, sites some di~stan~e~beyond~the entrance to the colon.
Electrodes 14 and 15 ar~ formed on the in~er surface;20a of insulating loop 20 (see FI~. 3) from an 30 electrically~ conducting material, preferably a metal c3r : metallic alloy. Suitable materials include, for example,;copp x and nickel. Electrodes 14 and 15 : extend into support tube 11 where they are electrically : connected~to electrical leads 16.~:Elec~rical leads 16 may be detachable or may be GoDnected to elec~rodes 14 , ~:~; : ,: ~

~0 93~2~845 PCr/US93/Q406~
`'' ' 21`~4899 ~nd lS using conventional techniques, f or example, crimping or soldering.
Electrode~; 14 and lS may l~e attached to th~
inner surface 20a in~;ulating loop 20 using onventional S techniques that provide an intimate and durable bond, such a~; plating, Yapor deposition or chemical bonding.
Elec:trodes 14 and 15 should adhere to insulating loop 2 0 with a ~;u~f iciently strong bond 50 tha~
separation of the electrodes from loop 20 does not occur during surgery. This bond should also be suf f iciently s~rong and durable to resist the : deteriorating effects o~ multiple sterilizations. In a f irst embodiment of the present invention, electrodes 14 and 15 are preferably approximately 0.5 lS to 2 mils (12 . 5 to 50 microns) thick. As will be recognized by one ~skilled in the art, other thicknes~es ;: may be used as needed depending upon the current densities that are expected to be applied to the snaring loop.
Electrodes 14 and lS are isolated from each other on the working end of insulating loop 20 by is;olation gap~22. Isolation gap 22 reduces the likelihood of direct shorting of electrode 14 to electrode~15. ~App~icant has determined that for a 25; first ambodiment:of the present invention isolation gap~22 sho~ld provide a gap of at least approximately 20 mils (0.5 ~m3~ between electrodes 14 and 150 Electrodes 14 and 15 are el~ctri~ally isolatéd from:each other within support shaft 11 by loop holder 21, which extends within the bore of : support shaft 11 ~see FIG. 23. ~Loop holder 21 is formed from an electrically-insulating material, preferably a nylon or teflon-based material, and is preferably formed by an extrusion process~ Loop ~ 35 holder 21 exkends through support tube 11 for a length : ~ :

WO93/2184~ PCT/US93/0~065 2 1 3 ~ 8 g 9 sufficîen~ to isolate electrodes 14 and 15 from each other and from support shaft 11. Of course, if snaring instrument 11 is to be inserted into an int stinal tract or other curved passageway, a~d support ~haft 11 is thus made from a flexible material, then loop holder 21 ~hould also be made of a flexible material to : accommodate the ~en~ing of support shaft 11.
In a cordance with another aspect of the present in~ention, if desired, electrodes 14 and 15 may also be coated with an electrically-conducting "non-stick" coating. Such a coa~ing reduces accumulation of coagulum on~the surface of loop 12. The'non-stick coating should pro~ide an intimate contact with the surface of loop 12 but not significantly impede :15 el ctrical current flow through the ~xotruding tissue.
Furthermore,; of course, if a non-stick coating is applied to loop 12, it should not allow electrodes 14 :: and 15 to electrically short together. Thus 9 the non-stick coating material should not be proviaed in 20~regions such as:isolation gap 22 or other similar régions where shorting between electrodes may occur if there is a contînuous path of elec~rically conductîng }~ non-stick coating ~e.g., the~outer surface of loop 12)~
Masking,~;selective removal steps~ or other conventional 25~ techniques~can:be~used to selectively~provide the non-stick:coating in desired regions and thereby prevent shorting~of the:electrodes.
If:a non-sticX coating is desired, its thicXness should preferably be în the range o~
approxîmate~ly 0.5 to 1 mil (12.5 to 25 microns).
Furthermore,~;the material may be, for example, a : ^composite of si:lver and teflon.. In partîcular, the coating may be product number ~W 271790A, available from Acheson-Colloids Company, a~divîsîon of Acheson :~"
,~ ~:::

~093/2t~5 P~T/US93/~06~
i 213~99 Industries, Inc~, Port ~uron, Michigan, which is asilver-filled teflon material. In accordance with an additional aspect of . the present invention, if desired, electrodes 14 and 15 : 5 may be coated with an overlayer of biocompatible metal : or metallic alloy that prevents chemical interaction between electrodes 14 and 15 and tissue. Such an : overlayer protects a patient from exposure to electrodes 14 and 15 should those electrod~s contain constituents: that might undesirably interact with a . patient's tissue. Preferred overlayer materials, include, for example, pla inum and titanium having a thickness of approximately 20 to 200 microns. Any conventional t.echnique to apply the biocompatible metal overlayer to the electrodes can be usPd, for example, : plating or vapor~deposition.
Referring now to FIGS~ 4-6, an alternative embodiment 30 of~:the present invention is described.
Snaring in~trumen~ 30 is similar in other respects to 2~0 ~ nar~iny instrument;lO~shown in FIGS0 1-3, except for the structure of snaring loop 40. Thu~, snaring instrument 30 includes support shaft 11, loop holder~21:,:~an~actuator (not shown) disposed ~rom the proximal~end of support shaft 11, and ~lectrical leads 25~ not shown)~for connecting the electrodes of snaring instrument~;30:~to a~p~wer source.
Snaring loop 40 includes electrodes 41 and 42 disposed :in parallel relation around the upper and lower portions,:respectively, of the inside surface 43 30~ of insulating loop 44. Electrodes 41 and 42 are : separated:by an isolation gap 45 tha~ serves the same purpose as i~solation gap 22 described with respect to : : the first embodiment of the~present in~ention shown in ~, :
: FIGS. 1-3, i.e., it electrically isolates e~ectrodes 41 : 35 ~nd 42. ~ ~
: ~ :

, ~ , , WO93/21~5 2 1 3 ~ 8 9 9 PCT1~S93/~4065~

With particular reference to FIG. 6, snaring instrument 30 provides for selecti~e necrosis and hemostasis o~ protruding tissue, such as polyps or the like, as follows. When ~naring loop 40 is positioned around and contacts a pro~ruding tissue lOl, an alternating-current electrical potential is provided acrass electrodes 4~ and 4~. Alterna~i~g current 45 conducted between electrodes 41 and 42 comprisss surface current 45a and bulk current 45b~
Surface current 45a conducts whenever there is a electric potential difference between electrodes 41 and 42. In accordance with the present invention, this current provides localized selective necrosis and : hemostasis to tissue lOl, since the distance of separation 46 between e~ectrodes 41 an~ 42 is fixed by the geometry of the snaring loop. In contrast to other types o~ bipolar snares ~here each e~ectrode forms half of the snaring loop, the current density of surface : curr~nt 45a is not generally dependent upon the 20~ circ~mference of ~naring loop 40. T~us, this ; embodiment provides large surace current den~ities to even large:diameter masses of protrudlng tissue, , ~ , : because the two bipolar electrodes are maintained at a fixed distance~from each other. The magnitude of this : 25~current density may therefore be fixed within a ;particular r~nge~by .election of the fixed separation distance 46~ between electrodes 41 and 42.
: A second type of current, bulk current 45b, is provided when the width 47 of protruding tissue lOl approaches the lateral separation distance 46 ~between electrodes 41 and 42. Bulk current 45~ conducts : through the bulk of protruding tissue 10l, as shown in F~G. 6, when ~he cross-sectional area of snaring ~ : loop 40 is contracted. Advantageously, a uniform ::~ 35 section of the protruding tissue is subjected to the :~:
:: :
, ~ 093/2~5 2 1 3 4 ~ 9 ~ PCT/US93/04~5 current passing between the electro~es. Thus, a larger region of the tissue is weakened by the current, facilitating severing of tissue by further contraction of the snare.
The fabrication of snaring loop 40, complete with electrode~ 41 and 42, is accomplished using the materials and principles discussed above with respect to the firs~ ~mbodimen~ of the snari~g instrument shown FIGS. 1-3, Preferably, the widths W1 and W2 (see :~ ~ 10 FIG. 5) of elect~odes 41 and 42, respec~ively, are approximately 1 mm. Furthermore, the separation W3 between electrodes 41 and 42, is also approximately 1 mm. Insulating loop 44 preferably has a thickness of ~ approximately 1 to 2 mils (25 to 50 microns3, and : : ~ 15 electr~des 41 ahd 42 preferably also have a thi~kness of approximately 0.5 to 2 mils ~12.5 to 50 microns).
Furthermore, snaring loop 40 may also contain a non-stick coating or biocompatible electrode overlayer as described heretofore with respect to snaring loop 12 of FT~S. 1-3.
. Referring now to FIGS. 7 and 8, another al*ernative:embodiment 50 of the present invention is described. Snaring instrument 50 is similar to snaring ~ ~: i~strument lO~shown in FIGS. 1-3, except for the `~ : 25 structure of snaring loop 60. Thus, sn~ring in~trument 50 includes support shaft 11, loop holder 51, an :::a~tuator ~no~ shown) di~pos d from the proximal end of support shaft 11, and electrical:leads (not shown) for connecting the electrodes of snaring instrument 50 to a :
::30 power source.
; Snaring loop 60 includes electrodes 51 and 62 disposed on a continuous insulating loop 63 of insulating materialO In turn, insulating loop 63 ~: comprises a continuous base loop 64 capable of withstanding typical tensile loads encountered by .
~ .

WO93J21~5 2 ~ 3 Ll 8 9 g PCT/US93/~06S~

snaring loop 60. Thus, in contrast to the previously described embodiments of the present inven~ion shown in FIGS. 1-6, the tensile loads of the snare are not imposed directly on the insulating loop of the instrument.
Base loop 64 may be a metallic wire or other similar material, preferably approximately 15 mils (Q.38 ~m~ in diameter. Base loop 64 may be covered with an eIectrically-insulating material to form insulating loop 63. Preferably, insulating loop 63 comprises a 0.5 ~o 2 mils (12.5 to 50 microns) thick coating of, for example a teflsn-based material. The working ~nd of snaring loop 60 is provided with an isolation gap ~5 that isola~es ~lectrode 61 from ~:~ 15 electrode 62. Snaring loop 60 m~y also contain a non-stick coating or biocompatible electrode overlayer, as described heretofore. ~
The pre~ent inven~ion also includes use of the above-described instruments in combina~ion with a ~ower supply tha* supplies an alternating-current wa~eform. Such de~ices are described, for example, in , ~ .
Schneiderman;U.S. Patent Ns. 4,092,986 and Farin U.SO
Patent No.~4,969:,~85.
More preferably, however, the present 2s inYention is used in combination with a power 5Upply and contro~ circuit that proYides an AC waYeform that provides a substantially co~stant voItage ou~put at user-sel~ctable levels, independent of the ~lectrical impedance éncountered b~ the electrodes. PrefPrably, the wave~orm allows for maximum power deli~ery using a ~ minimum peak-to-peak voltage level, su~h as provided by :~ the use of square waveforms. Such a power supply and control circuit is described in ~opending and commonly assigned U.S. patent application Serial No. 07~877,533, : 35 filed May l, 1992. This power suppIy and control ~ `'093/2l84~ 2 I 3 1 8 9 ~ - PCTIUS93/~4065 .

circuit is capable of delivering an AC waveform with a selec~able and substan~ially constant output ~oltage level in the form o~ a uni~orm square wave signal.
Tha constant output voltage-level feature of S the present in~ention allows for the reduction in the adherence of tissue ~o the working surface of the snaring instrument since applicant has observed that : coagulum buildup r~sults from the use of larger peak-to-peak voltag s. The use of such selectable and controllable voltages, in combination with the snaring instrument of the~present invention, produces an instrumen~ which provides substantially ~onsistent seIective necrosis and hemostasis, with little sticking : or coagulum buildup.
The present invention therefore includes the : method steps of~employing a snaring instrument with bipolar electrodes~, wherein operation of the instrument causes selective~necrosis and hemostasis of protruding issue, with little sticking or coagulum buildup on the : 20 ~snaring loop. :~s discussed above; the instrument p~eferably~is used in conjunction with an alternating current power~source having load-independen~
substantially~constant output voltaye:le~els.
Frequ~ncies~in he ~ange of approximateIy 10~0 kHz to 1 25:~:MHz and pe~ak-to-peak voltage~ in:~he range of apprsximately 10 to 120 volts (RMS) at the electrodes of:the snarin~;:instrument~ with~crest f~ctors (i.e., ratio of peak~voltage to RMS vo1tage) as clos~ to unity as possible (e.g., square waveforms3, are desirable.
30~ he methods of the present invention, suitable for:use in performing a greak variety of surgical procedures on various types~ of protruding tissue using an instrument having~ a~support shaft with a distal end and a proximal end~,~a snaring loop with ~irs~ and second electrodes disposed from the distal WO93/2184~ PCT/US93/04065~
213~ 899 end of the support shaf t, and an actuator means disposed from the proximal end of the support shaft for manipulating the instrument and for expanding and contracting the snaring loop, comprise the steps of:
(a) connecting the first and second electrodes of the ~ipolar snare instru~ent to a power source for supplying AC electrical power to the instrument;
~ ~b) creating an opening in a patient's body cavity or using a natural body ori~ice to pro~ide access to the patient's tissue;
: ~c) inserting the working surface and support shaft of the instrument through the access opening so that the snaring loop is disposed adjacent :~ 15 to the patient's protruding tissue;
(d) selecting and maintaining a substantially constant voltage level output across the power source, the voltage level output independent of :~ the impedance of t~e load ~onnected across the power : :
source;
(e) placing the snaring loop around :: : : :
: protruding issue;
(f)~ operating the actuator means to : reduce ~he cross-sectional area of the snaring loop ~o 25 :that the bipolar electrodes contact the protruding tissue; and : (g) activating the bipolar electrodes i ! 50 that an alternating current is conducted between the electrodes and through the protruding tissue to cause selective necrosis:and hemostasis of the tissue.
~:~:Operation of the apparatus in the range of 30 :~ :to 9o volts (RMS)~is desirable in many Gases, depending upon the impedance of the protruding tissu~ encountered during the surgical procedure. of course, one skilled in the art will also recognize that the above-stated ~ ~93/21~5 PCT/US93/0406~
~! 2 13 4~

-- 1 9 -- .:

voltages are those imposed across the electrodes of the bipolar instrument, rather than the output terminals of the power source, since allowance must be made for line losses encountered in the cables connecting the snaring instrument to the power source.
The use of a power source having a ~electable substantially constant voltage level output that is independent o~ load impedance provid~s sufficient power to cause selective necrosis and hemostasis of tissue.
Use of a substantially constant output level reduces the power delivered to the electrodes when they are not in contact with~tissue, i.e., open-circuited, ~nd reduces the likelihood of generating a current arc when : the elect:rodes are brought into contact ~ith the 15: tissue. Furthermore, use of a constant ~oltage level ; output that is independen~ of the load impedance i~hibits excessive current flow through ~he ti~sue : being operated upon. Consequently, th depth of tissue : necrosis can be more precisely controlled, and 2;0 l;ocalized overheating of the electrodes can be avoided.
Reduced localized heating of the electrodes inhibits qoagulum buildup,~which interferes with both efficient coagulation~and:the~snaring action of the instrument.
The~:various~embodiments described her in are 25 ~:~presented for;~purpose of illustration and not :limitation,~as~;the~present invention can be pract}ced with bipolar ~snarIng instruments;of any~type having two elertrodes di Q osed~on a snaring loop. The instruments - and methods of the present invention may be adaptedl as 30:~ may be required,~for use in operating on~any protruding tissue, vessel,~ or organ.
The described embodiments are presented for purposes of illustration and not of limitation, and the present invention is limited only by the claims that follow.

: : :

Claims (23)

WHAT IS CLAIMED IS:
1. A snare instrument for use in performing electrosurgery on protruding tissue, the instrument comprising:
a support shaft having a proximal end, a distal end, and a bore;
a strand of flexible electrically insulating material having first and second ends, the first and second ends of the strand engaged in the bore of the support shaft so that the strand forms a continuous snaring loop projecting from the distal end of the support shaft;
first and second electrodes disposed on the strand;
first and second electrical leads disposed from the proximal end of the support shaft, the first and second electrical leads connected to the first and second electrodes, respectively; and actuator means connected to the first and second ends of the strand for expanding and contracting the continuous snaring loop, the actuator means disposed from the proximal end of the support shaft, so that when the snaring loop is contracted around the protruding tissue, current may be selectively passed between the first and second electrodes to cause selective necrosis and hemostasis of the protruding tissue.
2. A snare instrument as defined in claim 1 wherein the first and second electrodes are spaced apart on the strand of flexible electrically insulating material to define an isolation gap therebetween.
3. A snare instrument as defined in claim 2 wherein the first electrode disposed on the strand ?O 93/21845 PCT/US93/04065 extends from the first end of the strand to the isolation gap and the second electrode disposed on the strand extends from the second end of the strand to the isolation gap.
4. A snare instrument as defined in claim 2 wherein the first and second electrodes and the isolation gap extend continuously from the first end to the second end of the strand, the isolation gap electrically isolating the electrodes from each other.
5. A snare instrument as defined in claim 3 wherein the strand further comprises an inner surface, and the first and second electrodes are disposed on the inner surface.
6. A snare instrument as defined in claim 4 wherein the strand further comprises a ribbon-like configuration having an inner surface, and the first and second electrodes are disposed on the inner surface.
7. A snare instrument as defined in claim 3 wherein the strand further comprises a substantially circular cross-section having an exterior surface, and the first and second electrodes comprise metallic coatings disposed on the exterior surface.
8. A snare instrument as defined in claim 1 wherein the strand of flexible electrically insulating material further comprises an inner strand of a high strength material having an exterior surface and a coating of electrically insulating material disposed on the exterior surface.
9. A snare instrument as defined in claim 7 wherein the strand of flexible electrically insulating material further comprises an inner strand of a high strength material having an exterior surface and a coating of electrically insulating material disposed on the exterior surface.
10. A snare instrument as defined in claim 1 wherein the support shaft further comprises a flexible portion near the distal end to permit insertion of the support shaft into a curved passageway.
11. A snare instrument as defined in claim 1 wherein the flexible portion extends to the proximal end to permit insertion of the support shaft into a patient's intestinal tract.
12. A snare instrument as defined in claim 1 wherein the first and second electrodes further comprise a biocompatible overlayer that prevents chemical interaction between said electrodes and a patient's tissue.
13. A snare instrument as defined in claim 1 wherein the first and second electrodes further comprise a coating of an electrically-conducting non-stick material.
14. A snare instrument as defined in claim 1 in combination with:
a source of high frequency current having a selectable substantially constant voltage level output independent of the load impedance across the output;

a first means for electrically connecting the first electrical lead to the output of the source; and a second means for electrically connecting the second electrical lead to the output of the source.
15. Apparatus as defined in claim 14 wherein the voltage level at the first and second electrodes is.
selectable from the range of approximately 10 to 120 volts (RMS) and the high frequency current is selectable from the range of approximately 100 kHz to 1 MHz.
16. A method of performing surgery on a patient's protruding tissue using an instrument having a support shaft with a distal end and a proximal end for use with a snaring loop having first and second electrodes, the snaring loop to be disposed from the distal end of the support shaft, and an actuator means disposed from the proximal end of the support shaft for manipulating the instrument and for expanding and contracting the snaring loop, the method comprising the steps of:
(a) providing a snaring loop comprising a strand of flexible electrically insulating material having first and second ends, the first and second ends disposed from the distal end of the support shaft, the strand forming a continuous snaring loop between the first and second ends;
(b) connecting the first and second electrodes of the bipolar snare instrument to a power source for supplying alternating-current electrical power to the instrument;

(c) using an opening in a patient's body to provide access to the patient's tissue;
(d) inserting the working surface and support shaft of the instrument through the opening so that the snaring loop is disposed adjacent to the patient's protruding tissue;
(e) selecting and maintaining a substantially constant voltage level output across the power source, the voltage level output independent of the impedance of the load connected across the power source;
(f) placing the snaring loop around protruding tissue;
(g) operating the actuator means to contract the snaring loop so that the first and second electrodes contact the protruding tissue; and (h) activating the first and second electrodes so that an alternating current passes between the first and second electrodes and the protruding tissue to cause selective necrosis and hemostasis of the tissue.
17. The method of claim 16 further comprising the step of setting the voltage level output of the power source so that the voltage across the electrodes of the instrument is in the range of approximately 10 to 120 volts (RMS).
18. The method of claim 16 further comprising selecting an alternating current voltage waveform having a crest factor near unity.
19. The method of claim 16 further comprising the step of setting the power source to provide a current with a frequency in the range of approximately 100 kHz to 1 MHz.
20. A method of performing surgery on a patient's protruding tissue using an instrument having a support shaft with a distal end and a proximal end, for use with a snaring loop having first and second electrodes, the snaring loop to be disposed from the distal end of the support shaft, and an actuator means disposed from the proximal end of the support shaft for manipulating the instrument and for expanding and contracting the snaring loop, the method comprising the steps of:
(a) providing the first electrode in the form of a continuous loop having first and second ends disposed from the distal end of the support shaft;
(b) providing the second electrode in the form of a continuous loop having first and second ends disposed from the distal end of the support shaft;

(c) connecting the first and second electrodes of the bipolar snare instrument to a power source for supplying alternating-current electrical power to the instrument;
(d) using an opening in a patient's body to provide access to the patient's tissue;
(e) inserting the working surface and support shaft of the instrument through the opening so that the snaring loop is disposed adjacent to the patient's protruding tissue;
(f) selecting and maintaining a substantially constant voltage level output across the power source, the voltage level output independent of the impedance of the load connected across the power source;

(g) placing the snaring loop around protruding tissue;
(h) operating the actuator means to contract the snaring loop so that the first and second electrodes contact the protruding tissue; and (i) activating the first and second electrodes so that an alternating current passes between the first and second electrodes and the protruding tissue to cause selective necrosis and hemostasis of the tissue; and (j) maintaining a uniform spacing between the first and second electrodes during expansion and contraction of the snaring loop, so that the first and second electrodes do not contact each other.
21. The method of claim 20 further comprising the step of setting the voltage level output of the power source so that the voltage across the electrodes of the instrument is in the range of approximately 10 to 120 volts (RMS).
22. The method of claim 20 further comprising selecting an alternating current voltage waveform having a crest factor near unity.
23. The method of claim 20 further comprising the step of setting the power source to provide a current with a frequency in the range of approximately 100 kHz to 1 MHz.
CA002134899A 1992-05-01 1993-04-30 Bipolar surgical snare and methods of use Abandoned CA2134899A1 (en)

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US07/877,538 US5318564A (en) 1992-05-01 1992-05-01 Bipolar surgical snare and methods of use
US07/877,538 1992-05-01

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US5318564A (en) 1994-06-07
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AU677782B2 (en) 1997-05-08
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ATE190479T1 (en) 2000-04-15
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EP0684791A1 (en) 1995-12-06

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