CA2241662A1 - An underwater electrosurgical instrument - Google Patents

An underwater electrosurgical instrument Download PDF

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Publication number
CA2241662A1
CA2241662A1 CA002241662A CA2241662A CA2241662A1 CA 2241662 A1 CA2241662 A1 CA 2241662A1 CA 002241662 A CA002241662 A CA 002241662A CA 2241662 A CA2241662 A CA 2241662A CA 2241662 A1 CA2241662 A1 CA 2241662A1
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Canada
Prior art keywords
electrode
tissue
electrosurgical instrument
tissue treatment
instrument
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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
CA002241662A
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French (fr)
Inventor
Nigel Mark Goble
Colin Charles Owen Goble
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Gyrus Medical Ltd
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Individual
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Priority claimed from GBGB9600377.7A external-priority patent/GB9600377D0/en
Application filed by Individual filed Critical Individual
Publication of CA2241662A1 publication Critical patent/CA2241662A1/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
    • A61B18/1485Probes or electrodes therefor having a short rigid shaft for accessing the inner body through natural openings
    • 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
    • A61B2018/1213Generators therefor creating an arc
    • 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
    • A61B2018/1425Needle
    • A61B2018/143Needle multiple needles
    • 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
    • A61B2018/1472Probes or electrodes therefor for use with liquid electrolyte, e.g. virtual electrodes
    • 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
    • A61B18/16Indifferent or passive electrodes for grounding
    • A61B2018/162Indifferent or passive electrodes for grounding located on the probe body
    • 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
    • A61B2218/002Irrigation
    • 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
    • A61B2218/002Irrigation
    • A61B2218/003Irrigation using a spray or a foam

Abstract

An electrosurgical instrument, which is used for the treatment of tissue in the presence of an electrically-conductive fluid medium, comprises an instrument shaft (10), and an electrode assembly (12) at one end of the shaft. The electrode assembly (12) comprises a tissue treatment electrode (14) and a return electrode (18) which is electrically insulated from the tissue treatment electrode by means of an insulation member (16). The tissue treatment electrode (14) is exposed at the distal end portion of the instrument (10), and the return electrode (18) has a fluid contact surface spaced proximally from the exposed end of the tissue treatment electrode by the insulation member (16). The exposed end of the tissue treatment electrode (14) is constituted by a plurality of tissue treatment filamentary members made of an electrically-conductive material, the filamentary members being electrically connected to a common electrical supply conductor.

Description

W O 97~4g94 PCT/GB97100066 AN UNDERWATER ELECTROSURGICAL INSTRUMENT

This invention relates to an electrosurgical instrument for the lle~ nt of tissue in the presence of an electrically conductive fluid medium, to electrosur ical api)al ~LIIS including such an instrument, and to an electrode unit for use in such an instrument.
Endoscopic electrosurgery is useful for treating tissue in cavities of the body, and is normally p~.ru,-l~ed in the presence of a dictencion me~ rn When the distension me~ lm is a liquid, this is commonly referred to as underwater electrosurgery, this term denotinu electrosurgery in which living tissue is treated usin~ an electrosurg2cal instrument with a 10 treatment electrode or electrodes imrnersed in li~uid at the operation site. A g~ceous medium is commonly emploved when endoscopic sur~ery is performed in a dictenci~le bodv cavity of larger potential volume in which a liquid medium would be nnctlit~hle, as is often the case in laparoscopic or gastroen~erolo~ical surgery.

1~ Underwater surgery is cornmonly pe~rullllcd using endoscopic techniques, in which the endoscope itself may provide a conduit (co.~ ol~ly rcfe. I ~d to as a working channel) for the passage of an electrode. Alternatively, the endoscope may be specifir~liy adapted (as in a resectoscope) to inc}ude means for mountin~ an electrode~ or the electrode may be introduced into a body cavity via a separate access means at an angle with respec~ to the 20 endoscope - a technique commonly referred to as tn~ng~ tiQn These variations in technique can be subdivided by sur~ical speciality, where one or other of the teçhni~ues has particular advantages given the access route to the specific body cavity. Fndoscopes with integral working ch~nnelc or those characterised as resectoscopes. are generally empioyed when the body cavity mav be ~ccecsed through a natural opening - such as the 2S cervical canal to access the endometrial cavity of the uterus, or the urethra to access the prostate gland and the bladder. FndQscopes specifically dec~ ed for use in the endometrial cavity are ~er~ d to as hysteroscopes. and those designed for use in the urinary tract include cystoscopes, urethroscopes and resectoscopes. The procedures of transurethal resection or ~dpOI ix.lion of the prostate gland are known as TURP and EVAP
30 respectively. When there is no natural body opening through which an endoscope may be passed. the terhni~lue of tri~n~ll~tion is commonlv employed. Tri~n~ tion is collllllonly R~l l~ltl) SHEET (RULE 91 ISA~EP

WO 97n4994 PCT/GB97/00066 used during underwater endoscopic surgery on jolnt cavities such as the knee and the shoulder. The endoscope used in these procedures is cornrnonly referred to as anarthroscope.

5 Electrosurgery is usually carried out usin~ either a monopolar instrument or a bipolar instrument. With monopolar electrosurgery, an active electrode is used in the opelaLil:~g reglon, and a conductive retum plate is secured to the patient's skin. With thisGe..~ current passes from the active electrode through the patient's tissues to the external retum plate. Since the patient ~ eprcsents a significant portion of the circuit, input 10 power levels have to be hi8h (typically 1~0 to 250 watts), to compensate for the resistive current limitin_ of the patient s tissues and. in the case of underwater electrosurgery, power losses due to the fluid merii~ which is rendered partially conduc~ive by the ,ese,lce of blood or other body fluids. Using high power with a monopolar ~ n~is also hazardous. due to the tissue heating that occurs at the return plate, which can cause 15 severe skin bums. There is also the risk of capaeili~e coupling between the ins~rument and patient tissues at the entry point into the body cavity.

With bipolar electrosurgery, a pair of electrodes (an active eiectrode and a retur electrode) are used together at the tissue application site. This arr~n~pm~nt has '~0 advanta_es from the safety standpoint. due to the relative proximity of the two electrodes so that radio frequency currents are limited to the region between the electrodes.
However, the depth of effect is directly related to the ~ict~n~e between the two electrodes, and. in arp~ic~tior-~ requiring very small electrodes, the iMer-electrode spacing becol"es very small, thereby lirniting tissue effect and output power. Spacing the electrodes further ~5 aparl would often obscure vision of the application site, and would require a mo~ific~tion in surgical tecl n~ e to ensure correct contact of both electrodes with tissue.

There are a number of variations to the basic design of the bipolar probe. For exarnple, U.S. Patent Specific~tion No. 4706667 describes one of the fitnri~m.ont~lc of the design, 30 narnely that the ratio of the contact areas of the retum electrode and of the active electrode is ereater than 7:1 and smaller than 20:1 for cutting purposes. This ransge relates only to RE~ ltU SHEET (RULE 91) IS.DJEP

W O 97n4994 PCT/GB97/00066 cuttine electrode configura~ions. When a bipolar instrument is used for desiccation or coa_.ulation, the ratio of the contacI areas of the two electrodes may be reduced to apl)ru~ aLely 1:1 to avoid di~l~-lLial electrical stresses occurrinP at the contact between the tissue and the electrodes s The electrical junction between the return electrode and tissue can be supported by wetting ofthe tissue by a con~ucfive solution such as normal saline. This ensures that the surgical effect is lirnited to the needle or active electrode~ with the electric circuit between the two electrodes being completed by the tissue. One of the obvious limit~tions with the design 10 is that the needle must be completely buried in the tissue to enable the return electrode to complete the circuit Another problem is one of the orientation even a relativeiY small chan_e in application angle from the ideal perpendic~ r contact with respect to the tissue surface, will change the contact area ratio~ so that a surgical effect can occur in the tissue in contact with the return electrode.
Cavity distension provides space for Paining access to the operation site, to improve Vicl~lic~tioTl~ and to allow for m~nip-ll~tion of instruments. In low volume body cavities, particularly where it is desirable to distend the cavity under higher pressure, liquid rather than gas is more commonly used due to better optical characteristics, and because it 20 washes blood away from the operative site.

Conventional underwater electrosurgery has been p~. ~v, ~"ed using a non-conductive li4uid (such as 1.~% glycine) as an irrigant, or as a ~ict~ncion me(lillm to elimin~te electrical con~uction losses. Glycine is used in isotonic conce"~ ions to prevent osmotic ch~n~s 25 in the blood when intra-vascular absorption occurs. In the course of an operation, veins may be seYered, with resultant infusion of the li~uid into the circulation, which could cause~
among other things, a dilution of serum sodium which can lead to a condition known as wata intoxir~ rl 30 The applicants have found that it is possible to use a conductive liquid mP~iilln~, such as norrnal saline~ in underwater endoscopic electrosurgery in place of non-conductive~

R~l;l l~ltU SHEET (RULE 91 ISA/EP

Wo 97t24994 PCT/Gs97/00066 eiectrolvte-free solutions. I~orrnal saline is the preferred distension medium in underwater endoscopic sureerv when electrosur~erv is not conlemplated~ or a non-electrical tissue effect such as laser treatmem is bein-~ used. ~Ithough norrnal saline (0.9%w/v, 1 50mmoll1) has an electrical conductivitv somewhat greater Ihan that of most body tissue, it has the advantage that displ~çement by absorption or e~travasation from the operative site produces little physiologicai effect, and the so-called water intoxication effects of non-conductive, electrolyte-free solutions are avoided.

Carbon dioxide is the preferl ed gaseous distension medium. primarily because of its non-10 toxic nature and high water solubility.

ln endoscopic procedures in which the distension medi~lm is a gas, the applicants have found that it is possible to use an electrically-conductive gas (such as argon) in place of carbon dioxide Argon is conductive when excited into a discharge state. and has been 1~ employed in both endoscopic and conventional monopolar electrosurgery as a method of increasing the dist~n~e between the tissue and the instrument~ by providing a conductlve path between the two when high volta~e electrosurgical ouputs such as spray or fulgurate are being used. The hi8h voltages used in this application result in a very low per.c~ .on ofthe electrosurgical effect into the tissue. making the technique only suitable to control 20 bleeding from multiple small blood vesseis. This allows the sur~eon to stanch bleeding from multiple sites in a surgical wound using a rapid "painting" technig~1e. rather than applying eiectrosurgery to each individual bleeding site. The ar~on gas is delivered through a hollow surgical instrument~ and passes over the monopolar electrode tA~,osed at the tip of the instrument as a strearn. This produces a region at the operative site which 25 i5 rich in argon, and which contributes to the distension of the body cavitv. High voltage monopolar eleclr~s~rgical outputs are undesirable in endoscopic surgery, because of the risks of A~m~ing structures outside the field of vision, bv either capacitive or direct courling to a portion of the instrument remote from the operative site often outside the field of vision of the operator.

REC~ D SHEET (RULE gl) ISAJEP

Wo 97/24994 PCT/Gs97/00066 The applicants have developed a bipolar inslrument suitable for underwater elec~rosurgery using a conductive iiquid or gaseous medium. This electrosur ical instrument for the L~ oftissue in the pleience of a fluid merii--m comprises an instrument bodv having a handpiece and an instmment shaft and an electrode assembly~ at one end of the shaft.
The electrode assembly comprises a tissue treatment electrode which is exposed at the extreme distal end of the instrument. and a return electrode which is electricallv inclllated from the tissue ~l eaL~l~cllL electrode and has a fluid contact surface spaced proximally from the exposed part of the tissue tre~trnent electrode. In use of the instrument. the tissue treatment elearode is applied to the tissue to be treated whilst the return electrode~ being 10 spaced proximally from the exposed part of the tissue llea~ ,nt electrode. Is normally spaced from the tissue and serves to complete an electrosurQicai current loop from the tissue ~leat.ll~ electrode through the tissue and the fluid medinm This electrosurgical instrument is described in the specification of the applicants' co-F)ending British Patent ApplicationNo. 9512889.8.
The electrode structure of this instrument, in co",~ination with an electricallv conductive fluid medium largely avoids the problcl"s experienced with monopolar or bipolar electrosurgery. In particular, input power levels are much lower than those Qenerally nec~aa ywith a monopola~ all~ ;f ~ (typically lO0 watts) Moreover, because of the 20 relativelv large spacin~ between its electrodes~ an improved depth of effect is oblained co."pared with conventional bipolar arrangement.

The aim of the invention is to provide an improved electrosurgical instrument of this type.
2 j The present invention provides an electrosurgical instrument for the ~ r, .ent of tissue in the pr~s~ ce of an electrically-con~ ctive fluid me~ m the instrument co",~ ng an insuument sha~, and an electrode assc.lll,ly at one end of the shaft, the electrode assembly comprising a tissue t-eal",e.,l electrode and a return electrode which is electricallv im~ ted from the tissue llcal~llclll electrode by means of an incui~tion member. the tissue 30 ~-eallncllt electrode being exposed at the distal end portion of the instrument, and the retum electrode havinP a fluid coMact surface spaced proximallv from the exposed end of REI~ ltl~ S~IEET (RULE 91) ISAIEP

W O 97/24994 PCTI&B97/00066 the tissue treatment electrode bv the insulation member, wherein the exposed end of the tissue treatmen~ electrode is constituted by a pluralitv of tissue l~e~ lrl~l fil~ y members made of an elec~ricallv-conductive materiaL the fil~m~nt~ry members being electrically connected to a common eiectrical supply conductor.

The return electrode is spaced from the tissue treatn~nt electrode so that~ in use, it does not contact the tissue to be treated~ and so that the electrical circuit is alwavs co",;lleted by the conductive fluid, and not simply by arcing between the electrodes. Indeed, the a~ nr~ ,l is such that arcing between the ~ cent parts of the electrode assembly is 10 avoided, thereby ensuring that the tissue tre~tment electrode can become enveloped m a vapour pocket so that tissue entering the vapour pocket becomes the pre~ d path for current to flow back to the return electrode via the conductive fluid The electrosurgica~ instrument of the invention is useful for cliccection~ resection, 1~ vaporisation, desiccation and co~S~ tion of tissue and col,lbinations of these filnctionc with particular applir~tiorl in hysteroscopic surgical procedures. Hysteroscopic operative procedures may include: removal of stlbm--coc~l fibroids, polyps and rn~lisJn~nt neoplasms, resection of co~a~ uterine anomalys such as septum or s ~l~se~Jt""~: division ofsynechiae (adhesiolysis); ablation of riice~ced or hypertrophic ~onrlo5nPtrial tissue; and ~O haemostasis.

The instrument of the invention is also useful for dissection~ resection, vapo~iaaLion, rOI-on and co~ tion of tissue and combin~tiQnc of these functions with particular application in arthroscopic surgery as it pertains to ~n~oscopic and percl~t~nçous 25 procedures ~.~""ed on joints of the body int.ll~riinv but not lirnited to~ such techniq~es as they apply to the spine and other non-synovial joints. Arthroscopic operativeprocedures may include: partial or complete ~ ;ccectomy of the knee joint inclu~linv ,r....~ 1 cystectomy; lateral retin~c~ r release of the knee joint; removal of anterior and posterior cruciate iiP,;~Il.f..~tc or re~.,.un~s thereof; labral tear rçsectio~ acromioplasty, 30 b~ e~,lu~"~r and subacromial deco-"~ession of the sho~llrler joint; anterior release of the L~"~u~"~...~.-.lil"!l~r joint; synovectomy, cartilage debridement. chondroplastv. division of RE~ U SH~R (RULE 91) ,SUEP

W O 97~4994 PCT/G B97/00066 intra-articular adhesions~ fracture and tendon debndement as applied to any of the svnovia~
joints ofthe bodv; in-lurinsg thermai shrinkage of joint capsules as a tre~tm~nt for recurrent disiocation, subluxation or repetitive stress injury to any aniculated joint of the body, disectomy either in the treatment of disc prolpase or as part of a spinal fusion via a 5 posterior or anterior approach to the cervical, thoracic and lumbar spine or any other fibrous joint for similar purposes; excision of f~ice~ced tissue; and h~Pmost~ci~.

The instrument of the invention is also useful for dissection, resection, vaporisation, ~erirc~tion and co~g~ tion of tissue and combinations of these Iunctions with particular 10 application in urological endoscopic (urethroscopy, cystoscopy, ureteroscopy and nephroscopy) and percutaneous surgerv Uroloeical procedures mav include: electro-~ o~ on of the prostate eland (EVAP) and other variants of the procedure commonlvreferred to as transurethrai resection of the prostate (TURP) inclu~ing, but not li~Lited to, interstitial ablation of the prostate gland by a percut~neous or perurethral route whether 15 pe,r~J"-,cd for benign or m~ nt disease; transurethral or perc~ npollc rPsectioJl of urinary tract tumours as they may arise as primary or seGonr~ary neoplasms and further as they may arise anywhere in the urolo_ical tract from the caiyces of the kidney to the external urethral meatus; division of strictures as they may arise at the pelviureteric junction (PUJ), ureter. ureteral orifice, bladder neck or urethra; correction of ureterocoele;
20 ~lu ' 3f of bladder diverticular; cystoplasty procedures as they per~ain to corrections of voiding dycfiln~tion; thermally induced shrinkage of peivic floor as a corrective L~eaL~ t for bladder neck descent: excision of ~ice~ced tissue, and haemostasis.

Surgical procedures using the instrument of the invention include introduing the electrode 25 assembly to the surgicai site through an artificial conduit (a cannula), or through a natural conduit which may be in an ~n~tQrniG~I body cavity or space or one created surgically. The caYity or space may be ~isten~ed during the procedure usinv a fluid or mav be naturallv held open bv ~n~tomlc~l structures. The surgical site may be bathed in a con~inuous flow of Gon~lctive fluid such as saline solution to fil} and distend the cavity. The procedures 30 may include Cimlllt~neous viewing of the site via an endoscope or usin_ an indirect .
vlClJ~ilc~tlQrl means.

R~l l~ltl) SHEE~ (~UL~ 91) IS~UEP

W O 97~4994 PCT/GB97/00066 In a plefell~d embodiment, a plurality of separate individual filaments constltute the fil~mPntArv members Advantageouslv~ the filamen~s each have a length Iyin~ within the range of from 0 j mrn to 5 mn~ in which case the inslrument is used for tissue removal by vapoli~d~ion Preferably, the filAmPntc each have a diameter Iying within the ranee of from 5 0 05 mm to 0 3 mm Alternativeiy. a single coiled filament constitutes the filamentarv members, the coils of the fil~m~nt Conctinltinsg the filAnlent~ry members 10 Preferably, the fi~mPnt~rv l-,e...be.~ extend longitlldin~lly from the extreme distal end of the instrument Alternatively~ the fil~..,f '-IA~ y members extend lalerally throueh a cut-out formed in a side surfâce of the insulation member ad3acent to the distal end thereof Conveniently, the return electrode is formed with a hood-like ex~ension which extends over the surface of the insulation l.-e.llber which is opposite the cut-out In another preferred embodiment, the fil~m~ntArv members are mounted within the in~Jl~tiotl u~ el in such a manner that they are axially movable relative to the inc~tion member between a first operating position, in which they extend partially from the ins ll~tion member. and a second operating position, in which thev extend fullv from the '~0 insulation member In this case. the instrument can be used for tissue removal by olisaLion when the fii~--e"Is are in the first operating position, and for desiccatlon when the fil~met~tc are in the second op~ Ling position Adv~nt~eously, the comrnon electrical supply conductor is a central conductor, the ~5 incul~tion I.lc.,.b~[ surrounding the central conductor The r,~ r ,lA,y members may be made from a precious metal such as plalinum or from a platinum alloy such as platinumiiridlum, piatinurNt--ngcten or platinumlcobalt The r.l~ "~1 Y ~e.l~er~ could also be made of nln~g~cten The insulation member mav be made 30 of a ceramic material, silicone rubber or glass Rk~ ltU SHEET (RULE 91 lSA/EP

wo 97/24994 PcT/Gss7/00066 Where the fil~ment~ry members are separate individual fil~mPnt~; they mav each have a len~th Iying within the ran~e of from ~ mm to I 0 mm. In this case. thev mav be made of stainless steel.

ln ye~ another pr~l~"ed embodiment~ the insulation member is forrned with at least one wing, the or each wing exlending distalh,~ from the insulation member to project beyond the tissue lrean~ L electrode. Preferably, the insulation member is formed with a pair of di~l~,LIically-opposed wings.

lO The invention also provides an electrode unit for an electrosur~ical instrument for the n taLmen~ of tissue in the ,~re~nce of an electricallv-condllcflve fluid meri j~lm the electrode unit CO~ ' a sha~ having at one end means for co~ F~ion to an insLI~lle~lL hAndp:f ce.
and, mounted on the other end of the shaft~ an electrode assembly cG~ llg a tissue Ir~ n electrode and a return electrode which is electrically incltl~ted from the tissue lleaLIll~,~lL electrode by means of an incuhtion Illemter, the tissue Ll~ f' ~l electrode being exposed at the distal end portion of the instrument, and the return electrode having a fluid contact surface spaced pl ~o~illlally from the exposed end of the Iissue trcalu~ent electrode by the insulation member, wherein the exposed end of the tissue tl~ t electrode is con~in-tlod by a plurality of tissue ~P~tll,c 1~ fil~ "l~. y members made of an electrically-20 conductive material, the filamentarv members bein ~ electrically connected to a co.-ll,lon electrical suppiy conductor.

The invention further provides electrosurgical ap~a.atus comprising a radio frequency generator and an electrosurgical instrument for the tr~tment of tissue in the p-~,se.-ce of 25 an ele~LI;~lly-condurtive ~uid m~flillm the instrument co~ lisill~' an instrument sha~, and an electrode assembly at one end of the shaft, the electrode assembly colll~ri:~ing a tissue Lre~ l electrode and a return electrode which is electricallv inc~ tf,~d from the tissue ele~,l,ode by means of an insulation member. the tissue ur<~ F .I electrode bein~
exposed at the distal end portion of the instrument, the return electrode havine a fluid 30 contact sur~ce spaced proximally from the exposed end of the tissue Ll eaLI-Ie.ll electrode by the insulation member. and the radio frequency venerator havinP a bipolar output P~E~ ltD SHEE~ (RIJLE gl) ISA/EP

W O 97~4994 PCT/GB97/00066 co~n~cted to the electrodes. wherein the exposed end of the tissue tr.o~tment electrode is conct~ ted by a pluralitv of tissue u~a~ nt fil~mPm~ry members madc of an e~ectrically-conductive material, the fil~mçnt~ry members being electrical~v connected to the radio fre~uency generator by a common electric supply conductor.

Advantageously, the radio frequency generator in~ludes control means for varying the output power delivered to the electrodes~ the control means being such as to provide output power in first and second output ranges, the first output range being for powering the electrosurgncal instrument for tissue dessication, and the second output range being for 10 powering the electrosurgical instrument for tissue removal by vaporisation. Preferably, the ~rst output ran_e is from about 150 volts to 200 volts~ and the second output ran_e is from about 250 votts to 600 volts, the voltage being peak voltages.

The invention will now ~e desc. ibcd in greater detail, by way of exarnple with r~,fe.~ce 15 to the drawings, in which:-Figure I is a .li..~ ;c side elevation of an electrode assembly at a distal end of a firstforrn of electrode unit constructed in accordance with the invention;

20 Fi ure 2 is a graph illustratin~ the hvsteresis which exists between the use of the electrode unit of Figure I in dçsicc~ting and vaporising modes;

Figure 3a is a dia~n.,...~ic side elevation of the first electrode unit, showing the use of such a unit for tissue removal by vaporisation;

Figure 3b is a diagrammatic side elevation of the first electrode unit, showin_ the use of such a unit for tissue desicr~-ion;

Figures 4a to 4c are dia~l a,.,.natic side elevations of the electrode assemblv of a second 30 form of electrode unit constructed in accordance with the invemion;

R~ll~ltL~ SHEET (RULE 91) ISAIEP

Figures ~a and 5b are diavrarnmatic side elevations of the electrode assembly of a third forrn of electrode unit constructed in accordance with the invention, Figures 6a and 6b are diagrammatic side eievations of the electrode assemblv of a fourth 5 form of electrode unit constructed in accordance with the invention;

Figures 7a and 7b are dia~rammatic side elevations of a fifth form of electrode unit constructed in acco~dance with the invention, 10 Figure 8 is a diagrammatic side elevation of a sixth form of electrode unit constructed in accordance with the invention, Figure 9 is a cross-section taken on the line A-A of Figure 8, 1~ Figure 10 is a dia~ ~ t I IC side elevation of a seventh forrn of electrode unit constructed in accordance with the invention;

Figures I l a to 1 I d are diag, a."",atic side elevations of further forrns of electrode unit constructed in accordance with she invention; and Figure 12 is a diagram showinS~ an electrosurgical al~pa~atus constructed in accordance with the invention.

Each of the electrode units described below is i~t~nded to be used with a conductive 25 diu~nci~n medium such as norrnal saline. and each unit has a dual-electrode structure, with the con~l~rtive medium ac~ing as a conductor between the tissue being treated and one of the electrodes, hereinafter called the return electrode. The other electrode is applied directly to the tissue, and is he.t:,l a~Ler called the tissue treatment ~actiYe) electrode. In many cases, the use of a liquid distension meriium is pl~e,able~ as it pr~,ve,~LSeXCeSSiYe 30 electrode te~l-p~,.at-lres in most circnmct~ncPC and largely ~ tes tissue sticlrina R~~ tv SHEET ~RULE 91 ~SAJEP

Referring to the drawings, Figure 12 shows electrosur~ical apparatus inçludinv agenerator I having an output socket 2 providing a radio frequencv (RF) output for an instrument in the form of a handpiece 3 via a connection cord 4 Activation of the generator I may be performed from the handpiece ~ via a control connection in the cord 5 4, or bv means of a foo~switch unit S. as shown. connected separatelv to the rear of the generator 1 by a footswitch connection cord 6 In the illustrated embodiment, thefootswitch unit 5 has two footswitches Sa and Sb for sPlectinp a desicç~tion mode and a vaporisation mode of Ihe generator I Icspe~ ely. The generator front panel has push buttons 7a and 7b for respectively setting decicc~tion and vaporisation power levels, which 10 are indicated in a display ~ Push buttons 9a are provided as an alternative means for selection between the desiccation and vaporisation modes.

The handpiece 3 mounts a detachable electrode unit E, such as the electrode units El to El I to be described below Figure I shows the first form of electrode unit El for det~ch~ble f~ct~ninP to the electrosurgical instrument handpiece 3~ the electrode Lmit comprising a shaft I 0, which is constituted by a semi-flexible tube made of ~t~inlecs steel or phynox electroplated in copper or gold, with an electrode assembly 12 at a distal end thereof At the other end 20 (not shown) of the shaft 10 means are provided for connect-ng the electrode unit EI to a h~nt~piece both mer.h~ni~lly and electrically.

The RF generator I (not shown in Fi~ure I ) delivers an electro-sur~ical current to the electrode assembly 1'. The generator incl~des means for varying the delivered output 25 power to suit di~renl electrosurgical requil e~ Ls. The generator may be as des.;~ cd in the specifi~tion of our co-pending British Patent Application 95 I 2888.0 The electrode assembly 12 in~ cles a central, tissue tre~l~..e..~ (active) electrode 14 in the fonn of a brush electrode. The active electrode 14 is connected to the generator I via an 30 integral central conductor 14a and a central copper con~ ctQr (not shown) positioned uithin the ~ ece ofthe instrument. The brush electrode 14 is conctinlted bv a pluralitv R~ll~tt~ S~IEE~ (RULE 91 IS~IEP

W O 97~4994 PCT/GB97/00066 of fil~ment~ oftl-nvcten, the fil~m~nt5 having ~ meters Iying in the range from 0.05mm to 0.3mm. A tapered ceramic insulation sleeve 16 surrounds the conductor 14a. A return electrode 18 which is constituted bv the distal end portion of the shaft 10. abuts the proximal end of the sleeve 16 An ouler in.~ ting coating 20 surrounds the pro,~ -al 5 portion of the shaft adjacent to the return electrode 18 The coating ~0 would be polyvinylidene fluoride, a polvimide. polytetrafuoroethylene~ a polyolefin, a polyester or ethylene tetrafluoroethylene.

By varying the output of the ge~ or I, the electrode unit E I of Figure I can be used for 10 tissue removal by vaporisation, or for desicc~tion Figure ~ illustrates how the RF
g~--c.alor I can be controlled to take advaMage of the hvsteresis which exists between the desiccation and the vaporising modes of the electrode unit El Thus, ~cqlmin~ theelectrode assembly 12 of the unit E I is h~ e. ~ed in a conductive mPr~ium such as saline~
there is an initial impedance "r" at point "O", the m~vnit~lde of which is defined by the 15 geometry of the electrode assembly and the electrical cond~rtivity of the fluid .~c~
The value of "r" will change when the active electrode 14 contacts tissue, the higher the value of "r" the greater the propensity of the electrode assembly 1~ to enter the ~apo~-sAIion mode. When RF power is applied to the electrode assembly 12 the fluid m~rlillm heats up ~ccllming the fluid metlillm is normal saline (0.9% w/v), the 20 te~per~LIlre coefficient of the fluid rneclium is positive, so that the correspondine ....pc~n~e co~ll.c,e~l is negative. Thus, as power is applied, the impedance initially falls and continues to fall with increasing power to point "B", at which point the saline in intim~te contact with the electrode assembly 12 reaches boiling point. Small vapour bubbles form on the surface ofthe active ele~,LIode 14 and the i.,.ped~nce then starts to 25 rise. Mer point "B", as power is increased funher, the positive power co~ffi~i~nt of i".~e~nce is domin~nt so that increasing power now brings about increasing impedance.

As a vapour pocket forms from the vapour bubbles, there is an increase in the power density at the residual electrode/saiine ~nterface. There is. however. an exposed area of the 30 ac~ive ele~ ode 14 not covered b,v vapour bubbles, and this funher stresses the interface~
producing more vapour bubbles and thus even higher power densitv. This is a run-awav R~ ltU SHEET (RULE 9t îSAfEP

W O 97/24g94 PCT/GB97100066 condition, with an e4uilibrium poin~ oniy occumng once the electrode is completely enveloped in vapour. For ~iven set of variables, there is a power threshold before this new equilibrium can be reached (point "C") 5 The re~ion of the Praph between the points "B'' and "C", therefore, represents the upper lisnit of the desiccation mode. Once in the vaporisation equilibrium state, the impedance rapidly increases to around 1000 ohms, with the absolute value depending on the system variables. The vapour pocket is then s~lst~ined by discharges across the vapour pocket between the active electrode 14 and the vapour/saline interface. The majority of power 10 ~ ;rgl-on occurs within this pockeI~ with concequ~nt heating ofthe active electrode 14.
The amoun~ of ener~y dissipation. and the size of the pocket. depends on the output voltage. If this is too low~ the pocket will not be sllct~in~ and if it is too high the electrode assembly 12 will be destroved. Thus, in order to prevent destruction of the elec2rode assembly 12, the power output of the generator I must be reduced once the 15 i~ eA~n~e has reached the point "D". It should be noted that, if the power is not reduced at this point, the power/impedance curve will continue to climb and electrode destruction would occur. The dotted line E in~ir~tes the power level above which electrode destmction is inevitable. As the power is reduced~ the impedance falls until, at point "A"~
the vapour pocket coll~pses and the electrode ass~ l.ly 12 reverts to the desicr~ n mode.
20 At this point, power ~lic~ ,Qn within the vapour pocket is insufficient to sustain it, so that direct contact between the active electrode 14 and the saline is re-est~bli~hPd. and the ped~1ce falls dr~m~tir~lly The power density at the active electrode 14 also falls, so that the t~,.."~c.a~L~re of the saline falls below boiling point. The electrode ass~ bly 12 is then in a stable dP ~ .ol- mode. With the generator described in the sperifir~tion of our 25 co-pending British patent application 9604770.9, the output is 350 to 550 volts peak for the ~/apolisalion mode, and aboul 170 volts peak for the d~siçc~tion mode.

It will be apparent that the elearode unit El of Figure I can be used for decicç~tion by opcd~illP the unit in the re~ion of the ~raph between the point "0" and a point in the region 30 between the points "B" and "C" In this case. ~he electrode assembly 12 would be introduced into a selected operation site with the actlve electrode 14 ~djacPnt to the t.issue ltU SHEET (RU~E 91) lSAJEP

CA 02241662 1998-06-2~

to ~e treated. and with the tissue, the active electrode and the return electrode 18 immersed in the saline. The RF _enerator I would then be activated (and cvclicallv controlled as described in the specification of our co-pendin British patent application 9604770.9) to supply sufficient power to the electrode assem~y 12 to m~int~in the saline S adjacent to the active electrode 14 at, or just below. its boiling poiM without creating a vapour pocket surrounding the active tip. The electrode assembly would then be m~nir-l~t~d to cause heatinP and dessication of the tissue in a required region adj~Gent to the active electrode 14. The electrode unit E I can be used for vaporisation in the region of the Yraph between the point "D" and the dotted line F which conctitl~tes the level below 10 which ~a~olisalion cannot occur The upper part of this curve is used for tissue removal bv vaporisation. It should also be apprecialed that the electrode unit E 1 could be used for cutting tissue. Ln the cuttin~ mode, the electrode unit E I still operates with a vapour pocket, but this pocket is much srslaller than that used for vaporisation, so that there is the least amount of tissue damane cornmpnctlrate with cutting. Typically, the Ye'~c~aLor 1 i operates at about 270 volts peak for cutting.

The temperature generated at the active electrode 14 is of the order of 1500~C in the vaporisation mode, so tha~ the active electrode is made of a malerial that can withstand such hi~h te.~ Lllres. Preferably, the active electrode 14 is made of tlln~c~n platinum 20 or a platinum allov ~ such as platinumliridium or piatinumJn~nvcten).

Figure 3a illustrates schPm~ric~lly the use of the electrode unit El of Figure 1 for tissue removal by ~,apo-lsaLion. Thus, the electrode unit E1 creates a sufficientlv hieh energy dencity at the active electrode 14 to vaporise tissue 2', and to create a vapour pocket 24 2~ surroundirlg the active electrode. The formation of the vapour pocket 24 creates about a 10-fold increase in contact ,l..ped~n~e with a concequent increase in output voltaYe. Arcs 26 are created in the vapour pocket 24 to complete the circuit to the return electrode 18.
Tissue 22 which contacts the vapour pocket 24 will lep~ese.ll a path of least electrical le~ -e to complete the circuit. The closer the tissue 22 comes to the active electrode 30 14, the more energy is conce,-L~ated to the tissue, to the extent that the cells explode as thev are struck bv the arcs 26. because the return path throuYh the conductive fluid (saline RECI l~ltu SHEET (RULE gl~
ISA~EP

in this case) is blocked by the high impedance barrier of the vapour pocket ~4. The saline solution also acts to dissolve the solid products of vaporisation.

Fieure 3b illustrates schematicallv the use of the electrode unit El for tissue desiccation.
S In the desicr~tion mode. output power is delivered to the electrode assemblv 12 in a first output range, so that current flows from the active electrode 14 to become heated~
~"~f, .~bly to a point at or near the boiling point of the saline solution. This creates small vapour bubbles on the surface of the active electrode 14 that incrcases the impedance about the active electrode.
The body tissue 2~ typicallv has a lower impedance than the impedance of the combination of vapour bubbles and saline soiution ~ eent to the active electrode 14 When the active electrode 14 surrounded by small vapour bubbles and saline solution is brought into contact with the tissue ''', the tissue bccon.es part of the preferred electrical current path.
15 Accol-l,n~ly, the preferred current path goes out of the active electrode 14 at the point of tissue contact. through the tissue 22. and then back to the return electrode 18 via the saline solution, as shown by the current path lines 28 in Figure 3b.

The invention has particular application in decsiç~tinp tissue. For tissue desicr~tin~ one 20 ~n,~.-cd ap~.uacl~ is to coMact only part of the active electrode 14 to the tissue ~ with the ~ -drr of the active electrode re.,.~ ing remote from the tissue and surrounded bv saline solution, so that current can pass from the aclive electrode to the return electrode 18 via the saline solution. without passing through the tissue For exarnple, in the embodiment shown in in Fi~ure 3b, only the distal portion of the active electrode 14 2~ CQ~ .1 c the tissue ~2, with the proximal portion rem~iQing spaced away from the tissue.

The invention can achieve dr~icc~tion with no or minim~l charring of the tissue ~. When the active electrode 14 comacts the tissue 22. current passes through the tissue. causing the tissue at. and around, the comact point to desicc~re The area and volume of 30 desicc~te~ tissue 30 expands eenerallv radially outwardly from the point of contact. As the tissue 2~ is d~ir.c~terl it loses its conductivity As the area and volume of decicr~ted R~~ ) SHEET (RULE g1 ISA/EP

tissue 30 grows. a point is reached where the conductivity of the tissue is less than the conductivitv of the heated saline solution surroundine the active electrode 14 The current wi!l prefer to follow the least-impedance path. Accordingly, as the impedance 5 of the tissue ~2 increases (due to desiccation~ to a point where il approaches or exceeds the impedance of the combination of vapour bubbles and saline solution surrounding the active electrode 14~ the preferred electrical current path will shift to a new path ~hrough the vapour bubbles and saline solution. Accord..l~l~, once a large enough portion of tissue is desicc~te~. most (or substantially all) the current flow necessarily shifts to pass directly 10 from the active electrode 14 into the saline solution Before the tissue 22 becomes charred or scorched. the increased il,~ped~nce of the d~-cicr-A~ed tissue 30 causes most of the current to follow the path through the saline solution. No current, or a very small amount of current, will continue to pass throu-~h the de~;c~Al~d tissue, and charrin~ will be prevented.

15 In the embodiment shown in Figure 3b~ the exposed~ stranded portion of the active electrode 14 allows parts of the active electrode to contact the tissue surface. while still InAllm~ ;llg most of the active electrode exposed portion out of contact with the tissue.
Re~'-AnSe most ofthe exposed portion of the active electrode 14 is out of contact with the tissue 22~ the current path will more easily shift~ upon desiccation of a sllffirient tissue 20 volume, from the path throu~h the tissue to a path that eoes directly from the active eiectrode to the saline solution.

When the electrode unit E I is in the d~sicc~tion mode, the flexibility of the brush electrode 14 offiers considerable advantages when working with small ~i~rn~ttor electrodes in irregular 2S body cavities in which large areas of tissue require decicc-AriQn. From a te~hnic~l CIA~ lO; 11, the renurn:active ratio is variable from > 1:1 in the "closed" form to ~ 1:1 in the "splayed" form. This variability of the return:active ratio is explained in oreater detail below with reference to Figures 4a to 4c.

30 Fieure 4 shows the second form of electrode unit E2 whose electrode assembly 3 2 inrl~ldes an active elearode 34 which is constituted by a pluralitv of fil~ ontc made of a conductive Rt~ ltD S~IEET (RIJLE 91 ISA/EP

material such as stainless steel. The fil~ments of the brush electrode 34 are much longer (lOmm as compared with 5mm) than the filaments of the brush electrode 14, as theelectrode unit E~ is intended primarilv for desiccation. In this embodiment~ thereturn:active ratio is variable from > ':1 in the "closed" form to ~ 1: 1 in the "splayed"
5 form. The electrode assembly 32 also includes a ceramic insulation sleeve 36. a return electrode 38 and an outer insulating~ sheath 40 The active electrode 34 is a brush electrode whose tip is flexible to provide a reproducible tissue effect which is subst~nti~lly independent of the application angle of the electrode with respect to the surface of the tissue T (see Figure 4c). Thus, the flexibility of the active eieclrode 34 results in 10 di~l; . ellLial contact areas of the active electrode dependent on the applied pressure. For example, Fiwre 4a shows the brush eiectrode 34 "closed" during the appiication of light pressure. and Figure 4b shows the brush "splayed" by firm tissue pressure. This enables the creation of a broader surgical effect than the di~mPt~r of the electrode 34 would otherwise allow, thereby reducinSg treatment time. Figures 4a to 4c also show the retum 15 path P for the current flow from the active electrode 34 to the return electrode 38 via the con~lctive me~ m This large variation in the return.active ratio is a feature which cannot be supported by conveMional bipolar designs. This variation in ratio can occur because the con~uctive path tO complete the electrical circuit is m~int~ined by the low impedance of the electrode contact with the con~ ctive fluid operating merii--m In order to sustain the iow impedance transfer of RF energy to the tissues, the RF generator must be controlled in such a way that vapour pockets cannot form at the interface between the active electrode and the tissue.
This allows the tissue contact to be continually wetted by the con~uctiye fluid so that, 25 whilst the tissue water is removed by thermal decicr~Tion, the impedance reaches an upper limit d~ ed by a point just below a voltage threshold above which vapour pockets will start to forrn. This, comhined with the greater insulation separation between the active and return electrodes, enables this type of electrode unit to deliver much higher powers effectively to the tissue for a given electrode dimension than anv known electrode unit.

RECI l~lttJ SH~ET (RULE 91) ISAIEP

W O 97~4994 PCT/GB97/00066 1~

Figures 5a and Sb show the third form of electrode unit E3 This unit E3 is a mo~lific~tion of the electrode unit ~. and its electrode assembly 42 includes an active eiectrode 44 which is co~ctinlted by plurality of filamen~s made of stainless steel. The active electrode 44 is, ~I,er~o~, a brush elearode and the fil~merlts of this electrode are of a similar length S to the fil~ments of the brush electrode 3~. The eiectrode unit Ei is, therefore, int~nrled primarily for desiccation. The electrode assembly 42 a}so includes a ceramic in~ tiQn sleeve 46, a return electrode 48 and an outer insul~ting sheath 50 The insulation sleeve 46 is made of a ceramic materia} and, like the insulation sleeve 16 of the electrode unit E I, it tapers towards the distal end of the electrode assembly 4~. Figure 5a shows the 10 electrode unit E3 in a non-operational position~ and Figure Sb shows the unit in desiçc~tinp mode against tissue T

Figures 6a and 6b show a fourth forrn of electrode unit E4 whose electrode assemb}y 52 includes an extensible active e}ectrode S4 in the forrn of a brush electrode. The fil~m~ntc 15 of the brush electrode 54 are made of t~lngcten~ pl~tim-n~, pl~tinllm/t~,n~ten or pl~tinllm/iridium. The electrode unit E4 also in~ des a ceramic inclll~tion sleeve 56, a return e}ectrode 58, and an inclll~ting sheath 60. As shown in Figure 6a, the active e}ectrode 54 can be withdrawn s~tbst~nti~lly within the insulation sleeve 56 so that on}y the free end por~ions of its fil~mPnts are exposed With the active electrode 54 in this position, 20 the electrode unit E4 can ~e used to vaporise tissue in the manner described above with l~f~,~, ce to Figure 3. On the other hand. if the active electrode ~4 is extended ~see Figure 6b), so that its fil~mentc extend fu}}y from the distal end of the sleeve 56, the electrode unit E4 can be used for desicc~tion. The ratio of the contact areas of the return to active e}ectrodes of the unit E4 can, therefore, be varied between the fu}ly retracted active 25 electrode position (in which the ratio is hi_h and the unit is used for vaporisation), and the ed position (in which the ratio is low and the unit is used for desir~tion) The unit E4 achieves its dual filnrtjo~ ity by varving the extent by which the fil~ tont~ of the active e}ectrode 54 are extended. Dua} functionality could also be achieved by varying axial separation between the active electrode 54 and the return electrode 58 ~for e~ le by 30 valying the length of the inClll~tion sleeve 56). With a large extension of the fil~ tc of the active electrode 54 or with a lar~e axial electrode separation. a lar e electric field is R~LIl~ltU SHE~T (RUI~ 91 I SAIEP

W O 97~4994 PCT/GB97/00066 ~0 created. so that more tissue is affec~ed With no extension of the fil~mentc of the active electrode 54 or with a reduced electrode separation, a smaller electric field is produced, and is used for cutting or vaporisation in circumstances where no collateral thermal damaee to tissue is desirable. The larger electric field pattern is desirable for desiccation~
5 or in circ~mct~nces where the desiccation of collateral tissue is desirable to prevent haemorrhage from a cut surface.

De~e~ upon the ratio of the return:active electrode area, therefore, the brush electrode of the invention can have a dessir~tion function (as exemplified by the embodiments of 10 Figures 4 and 5) a vaporisation function (as exempiified by the embodiment of Figure 3)~
or a dual desiccationivaporisation fi~nction (as exemplified bv the embodiment of Fieure 6).

As indicated above, the primary use for the desicr~tinP brush is in providinP a flexible, 15 broad area elec~rode for dPcicc~tin-~ large irregular areas of tissue. The require,-le.~l to treat such areas occurs in hysteroscopic surgery - desicc~tion of the endornetrial lining of the uterus, and in urological surgery - desiccation and shrinkage of bladder diverticular.
In both inct~nrec~ the electrode is introduced through the working channel of the entloscope.
lntroduction of the desiccatin~ brush with a long and flexible. fil~ment~rv structure can prove ~ c~lFm~tir~l when the working channel of the endoscope is angled or includes steps in the inner bore. This can deform the brush fi~ ents which, once inserted. cannot be adjusted and may not col~rl" to the area of tissue to be treated. Bendin_ back of the 25 fil~m~ntc may also inadvertently create an electrical short to the return electrode.

Whilst preserving the desired fimctions of flexibilitv and contact area ~eometrv dependent on the pressure of application, the basic desiccatin_ brush can be modified to overcome this p,c~ '-m For ~Y~rnri~ the brush f.l~ can be sirnply twisted together. Preferably.
30 however, the î.l~.n. ..lc are welded togaher at their dista} ends as shown in Fieure 7 which shows a fifth forrn of electrode unit E5. The electrode unit E5 inçl~des an active electrode RECII~tU SHE~ ~RULE 91) ~S~'~P

64 in the form of a brush electrode whose filaments are made of pl~tin~
pl~tinnm/tungsten or platinum~iridium The distal ends 64a of the fii~mPntc are welded together as shown in Figure 7a. This prevents distortion of the filaments in the working channel of an endoscope~ whilst perrnittin~ bowing of the fil~m~ntc (as shown in Figure 7b) 5 to increase tissue contact area The electrode unit E5 includes a ceramic insulation sleeve 66, a return electrode 68 and an outer inclll~ting sleeve 70 In the dual funclion brush electrode, the return:active electrode area can be elevated to a level which is capable of producing tissue ~al)ollsd1ion. Obviously, with a very srnall active 10 electrode area at the extreme of this range, the amount of tissue which can be desicr~t~d beco-"es too small to be practically usefiul. If ~ however, the ratio is confi ured in the mid-range, then the same electrode can be used to produce both effective desiccation and tissue removal by vaporisation The short brush described in ~igure I is one exarnple of such a dual purpose electrode. Given ~hat the fil~m~nt5 cannot be fabricated in ~ sc steel to 15 support vaporisation, tungsten fil~n~ents are the p~ef ,l~d material in the short brush due to their rigidity overcoming the issues of distortion during introduction. Platinum alloys withstand the high vdpG~ Lion te.l.pe~ res better than tuncgcten but, due to their flexibility and the ~nn~ling process during use, cannot be used in the short brush form.
Platinum alloy dual-function brush-type electrodes, therefore, require the mo(lific~tior~c of 20 twisting, braiding, or weldin~ of the distal tips to prevent distortion.

These co..~ Fd multi-fi~nctio~l brush electrode forms are particularly useful in removing tumour masses or polyps ~ncol~nte~ed during hysteroscopic and urological surgery. They can vaporise the tumour bulk, incise the stalks of polyps, and desiccate any ble~ding 25 vessels or the base of the tumour without the need to change electrodes.

ln these multi-functional forms, the active electrode area is maximised for desiccation whilst still being capable of vaporisation or cutting functions The minim~lm ratio dPpen~s on four important critera. namely The intrinsic impedance of the tar~et tissue.

REll~ltU SHEET (RULE 91 ISAIEP

2. The volume of the body cavity 3. The configuration of the active electrode.
4 The maxlmum output power from ~he RF generator 5 The configuratlon of the aclive electrode obviouslv influences the ratio~ with cvlindrical forms repres~ P the lowest ratio for a ~iven iength, but the other factors relate to the inability of the electrode tO retain a vapour bubble The filaments of the brush-type electrodes retain vapour bubbles~ which helps m~int~in the vaporisation condition.

10 An arthroscope electrode may be characterised as short (100-140rnrn), rigid with a workinP di~rneter up to 4mm. It can be introduced through a stab incision into a joint cavity (with or without a cannula) usinY the tri~n~ lation tec~ni~ue. When an arthroscope includes a brush electrode of the type desc, ;bed above, it is operated with a motion which co.. o,-ly moves the brush electrode between the 9 o'clock and 3 o'clock positions on the 15 arthroscopic image. As a result, the tissue to be treated is co,~ .only approached at a shallow workin~ angle with respect to the axis of the electrode. The electrode for ~ ll.oscol)y thus needs to have an effect cor Cistent with this aneled approach to the tissue.
The tissue to be treated. such as m~nisc~l cartilage, is co-..,.~nnly dense and of a high electrical imped~n~e such tissue having a free edge re,~lese,.~ a cornrnon injury site 20 where l~eatlllcnt is required The drawback of known arthroscope electrodes which are soiid form electrodes is that. because the joint spaces are commonlv small (the jolnt spaces in the knee being typically 60-100 mls under fluid ~lict~ncion)~ the vapour bubbles generated are large and tend to cause problems with visoqlls~tiorl 2~ Figure 8 shows an arthroscope electrode unit E6 constructed in accordance with the invention. The electrode unit F6 Ir~çludes an active electrode 74 which is con.ctinlte~t by a plurality of fii~mPntc made of tun_sten or an alloy of tun~sten or pl~tim~m The active (brush) electrode 74 is connected to an ~: eenerator (not shown) via a central copper conductor (also no~ shown). A ceramic insulation sleeve 76 surrounds the central30 conrl~)ctnr, the r~ 74a ofthe brush electrode passine alon the insulation sleeve and extending la2erallv therefrom through a cut-out 76a. A return electrode 78, which is R~ll~tU SHEET (RULE 91 ISA/EP

conslituted bv the distal end of the inslrumen~ shaft, surrounds the proximal end of the sleeve 76. Ar outer in.c~ ting coatin_ 80 (which would be polwinvlidene fluoride, a polyimide, polvtetrafluoroethvlene. a polyolefin, ~ polvester or ethylene tetrafluoroethvlene) surrounds the proximal portion of the shaft ad.~aeent to the return 5 electrode 78 The return eiectrode 78 is formed with a hood-like extension 78a which extends over the surface of the sleeve 76 which is opposite ~o the cut-out 76a. The electrode unit E6 can~ thus, provide maximum tissue engagemen~ for shallow working angle applications. and is known as a side-effect electrode.

10 Because of the higher Imr~e~ e of the tar_et tissue, Ihe arthroscopic multi-function brush electrode should support a lower ratio than electrodes desisgned for hysteroscopic and urological applications where the tissue is more vascular. Redncin~ the ratio does.
however, have one drawback in body cavities of srnall volume, such as the knee joint which is typically 60-80 mls, and that is heating of the surrounded irrigant or distension fluid.
1~ Heating occurs primarily during the application of power to reach the vaporisation threshold. Once the threshold has been reached~ the power requi~ typically falls by 30-50%. Pceducin~ the electrode ratio increases the power re~ui~.-,ent to reach the threshold so that. despite the hi~h i,l,~edance of the target tissue~ it is undesirable to reduce the ratio to the lowest value capable of supporting vaporisation In addition. the hiPh impedance is due to lack of vascuiarity of such tissues as meniscal cartilage. Except, therefore, when muscle or synovial tissue is being treated. the primary fimction of the athroscopic brush electrode is that it should provide rapid debulking of dense, avascular tissue. Desiccate fi~nrtion~lity is not a requirement of such an instrument.
25 Indeed, verv short rigid brush electrodes with electrode ratios greater than 5:1 are desirable. The only reason for not elevating the ratio filrther is the need to engage the maximum amount of tissue and simultaneously reduce procedure time.

A short, rigid brush eiectrode (of the type described above with refe, ~nce to Figure I or 30 Figure 6a~ can be thou~ht of as an end-effect electrode which has tissue debulking precision with minimal therrnal spread. Consequentlv~ it can be used to create discre~e R~ll~ltU SHEE~ (RULE 91 ISPJEP

W O 97n4994 PCT/GB97100066 ~4 holes in tissue~ ~hereby to creale an access channel to tissue deep to the surface. as may be required as part of an interstitial ablation technique on a tissue mass such as a prostate adenoma or a uterine fibroid (myolysis) This use of a vaporisinv~ end-effecl, techni~ue enables only the fibroid to be removed by complete debulking leaving a resection margin 5 corlfulllJng to the "false capsule" of the fibroid No normal tissue is removed and, due to control of collateral thermal effects at the endometrial resection margin, the scarring is reduced to a minin~llrn~ thereby increasing what chances there were of restorinQ fertility ~ltlition~lly~ of course, ~apuri~lion does not produce resection chiypi~l~,s to interfere with viC~ is~tion and prolong the procedure through the need to wash them out once the 10 resection is completed Conventional loop eiectrode resectoscopes require removal of normal tissue surroundin_ such fibroias. and this is disadvama eous because it increases the chance of blee~tng the risk of uterine perforation and the scarrinsg of the uterus This latter aspect is particularlv undesirable when the procedure is being pelro.ll,cd in an attempt to restore fertility Altematively, a short, rigid brush electrode can be used to debulk a tumour (such as a fibroid, a bladder tumour or a prostate adenom~), or it can be used with the mlllti~le puncture or drilling technique In this case, after removing the intrauterine portion, the intramurai portion can be treated by creating ("drilling") a series of holes into the abnol ,.lal 20 tissue whether. for example~ this is a fibroid or prostatic adenoma To assess the depth of p~ aLIOn, marks may be provided on the eiectrode shaft at measured di~t~ncec from the tip, and hence to co...~)a,e the depth of p~t;LIalion a_ainst the pre-operative results of tests pe,~ul.-.ed to çst~bli~h size of the turnour or adenoma The residual tissue bridges will shrink as part of the healing process Whilst not removing the whole tumour, this25 technique is safer and quicker than removing the entire fibroid or prostatic adenoma. when l~e.,l-..e--l is bein8 performed either for menorrhagia or bladder outflow obstruction.
c~Li~rely.

Another problem with workin~ in the confined space ûf a joint cavity is in preventing 30 damage to a~cent structures, particulariy when the vaporisine effect is e~-h lnce~l and both the tissue densitv and a~ AI;on anele make eng~gPmPnt and location difficult. This REt~ ltU SHEEt (RULE 91 ISAlEP

W O 97t24994 PCT/GB97/00066 protection feature is intnnsic in the side-effect brush of Figure 8, when the insulation sieeve 76 protects tissue above. beiow and behind the active electrode window 76a which onlv occupies a small arc of the cross-sectional form (as shown in Figure 9) 5 Fivure 10 shows the electrode assembly of the seventh form of electrode unit E7 This electrode assembly includes a central~ ~issue treatment (active) electrode conctitllted by a plurality of fil~m~nt~ made of tungsten or an alloy of tl-ngcten or pl~tin~lm a tapered cerarnic inc~ tjon sieeve 86, a retum eiectrode 88, and an outer inclll~tinE sleeve 90 The insulation sleeve 86 is formed with a pair of diametrically-opposed, f~. wardly-e~ct~n~in~
10 wings 86a which project beyond the active electrode 84 The fil~mPnt5 cor,,l;tu~;~,g the active eiectrode 86 extend onlv a short distance from the distal end of the insulation sleeve 86. thereby cosl~titl nins~ a very short brush electrode The electrode unit E7 has therefore~
a large return:active electrode ratio. so that this electrode unil is intenrlecl pnmarily for a tissue removal by vaporisation The electrode unit E7 is particu}arly useful for 15 electrosurgical operations on m~nicc~l cartilage or any other eiongate l~min~te structure which is to be treated from the side, as the wings 86a can be used to trap the cartilage against the active electrode 84 The configuration of the wings 86a also assists in preventing u~ ceCc~ y exposure of the active electrode 84, which may otherwise darnage adja~Pnt structures when workin~ in the confined spaces commonly encountered in 20 endoscopic sur~ely Figures I la to I ld show eighth, ninth, tenth and eieventh forms of electrode unit E8 to El 1, each of which i~COI ~o.~tes an active electrode in the forrn of a coiled spnng fil~m~lt 94 The electrode units E8 to El 1 each inc'ludPC an insulation sleeve 96, a return electrode 25 98 and an inc~ tinv sheath 100 The electrode unit E8 of Figure I l a is similar to that of Figure 5a, being intt~n~l~d primarilv for desic~:~tion. and the eiectrode unit E9 of Figure I Ib is similar to that of Figure R being Inlended primarily for vaporisation The eiectrode unit ~10 of Figure I Ic is similar to that of Figures 8 and 9, in that the coil electrode 94 is forrned in a cut-out 96a forrned in the side of the incul~tion sleeve 96. and the return 30 electrode 98 is forrned with a hood-like extension 98a which extends over the surface of the sleeve 96 which is opposite to the cut-out 96a The electrode unit E10 can, thus.

R~ll~ltl~ SHEE~ (RULE gl~
ISAfEP

provide maximum tissue engagement for shallow workinv anUle applicalions. and isanother form of side-effect electrode. The electrode unit E I I of Figure I I d is similar to that of Figure 10. in that the insulation sleeve 96 is formed with a pair of diametrically-opposed, forwardly-ex~endin~l wings 96b In each of these embodim~ms, the active 5 electrode 94 is made of an allov of pl~tin~lm The electrode units E8 to ~1 1 are similar to the brush-type electrodes of Figures I to 10, and have simi}ar surgical effects, apart from the fact that they elimin~te the risk of splaying (which is advantageous in certain electro-surgical procedures~ They have, however, the 10 advantage of simplifying the assembly procedure, particularlv when using platinum alloy materials.

lt will be apl)arc.~l that modification could be made to the electrosurgical instruments described above. For example, the insulation sleeves 16, 36, 46, 56, 66, 76, 86 and 96 15 could be made of a silicone rubber (such as a silicone polyurethene), glass, a polyimide or a the, Inoplastics material.

hE~ itL) SHEET (RULE gl~
ISA/EP

Claims (24)

1. An electrosurgical instrument for the treatment of tissue in the presence of an electrically-conductive fluid medium, the instrument comprising an instrument shaft, and an electrode assembly at one end of the shaft. the electrode assembly comprising a tissue treatment electrode and a return electrode which is electrically insulated from the tissue treatment electrode by means of an insulation member the tissue treatment electrode being exposed at the distal end portion of the instrument, and the return electrode having a fluid contact surface spaced proximally from the exposed end of the tissue treatment electrode by the insulation member, wherein the exposed end of the tissue treatment electrode is constituted by a plurality of tissue treatment filamentary members made of an electrically-conductive material, the filamentary members being electrically connected to a common electrical supply conductor.
2. An electrosurgical instrument as claimed in claim 1, wherein a plurality of separate, individual filaments constitute the filamentary members.
3. An electrosurgical instrument as claimed in claim 2, wherein the filaments each have a length lying within the range of from 0.5 mm to 5 mm.
4. An electrosurgical instrument as claimed in claim 2 or claim 3, wherein the filaments each have a diameter lying within the range of from 0.05 mm to 0.3 mm.
5. An electrosurgical instrument as claimed in claim 1, wherein a single coiled filament constitutes the filamentary members the coils of the filament constituting the filamentary members.
6. An electrosurgical instrument as claimed in any one of claims 1 to 5 wherein the filamentary members extend longitudinally from the extreme distal end of the instrument
7. An electrosurgical instrument as claimed in any one of claims 1 to 5 wherein the filamentary members extend laterally through a cut-out formed in a side surface of the insulation member adjacent to the distal end thereof.
8. An electrosurgical instrument as claimed in claim 7 wherein the return electrode is formed with a hood-like extension which extends over the surface of the insulation member which is opposite the cut-out.
9. An electrosurgical instrument as claimed in any one of claims 1 to 6 wherein the filamentary members are mounted within the insulation member in such a manner that they are axially movable relative to the insulation member between a first operating position in which they extend partially from the insulation member, and a second operating position in which they extend fully from the insulation member.
10. An electrosurgical instrument as claimed in any one of claims 1 to 6 wherein the insulation member is formed with at least one wing the or each wing extending distally from the insulation member to project beyond the tissue treatment electrode.
11. An electrosurgical instrument as claimed in claim 10. wherein the insulationmember is formed with a pair of diametrially-opposed wings.
12. An electrosurgical instrument as claimed in any one of claims 1 to 11 wherein the common electrical supply conductor is a central conductor the insulation member surrounding the central conductor.
13. An electrosurgical instrument as claimed in any one of claims 1 to 12 wherein the filamentary members are made of a precious metal such as platinum.
14. An electrosurgical instrument as claimed in any one of claims 1 to 12 wherein the filamentary members are made of a platinum alloy such as platinum/iridium, platinum/tungsten or platinum/cobalt.
15. An electrosurgical instrument as claimed in any one of claims 1 to 12, wherein the filamentary members are made of tungsten.
16. An electrosurgical instrument as claimed in claim 2, wherein the filaments each have a length lying within the range of from 5mm to 10mm.
17. An electrosurgical instrument as claimed in claim 16, wherein the filaments are made of stainless steel.
18. An electrosurgical instrument as claimed in any one of claims 1 to 17, wherein the insulation member is made of a ceramic material.
19. An electrosurgical instrument as claimed in any one of claims 1 to 17, wherein the insulation member is made of silicone rubber.
20. An electrode unit for an electrosurgical instrument for the treatment of tissue in the presence of an electrically-conductive fluid medium, the electrode unit comprising a shaft having at one end means for connection to an instrument handpiece, and, mounted on the other end of the shaft, an electrode assembly comprising a tissue treatment electrode and a return electrode which is electrically insulated from the tissue treatment electrode by means of an insulation member, the tissue treatment electrode being exposed at the distal end portion of the instrument, and the return electrode having a fluid contact surface spaced proximally from the exposed end of the tissue treatment electrode by the insulation member, wherein the exposed end of the tissue treatment electrode is constituted by a plurality of tissue treatment filamentary members made of an electrically-conductive material, the filamentary members being electrically connected to a common electrical supply conductor.
21. Electrosurgical apparatus comprising a radio frequency generator and an electrosurgical instrument for the treatment of tissue in the pressure of an electrically-assembly at one end of the shaft the electrode assembly comprising a tissue treatment electrode and a return electrode which is electrically insulated from the tissue treatment electrode by means of an insulation member, the tissue treatment electrode being exposed at the distal end portion of the instrument the return electrode having a fluid contact surface spaced proximally from the exposed end of the tissue treatment electrode by the insulation member, and the radio frequency generator having a bipolar output connected to the electrodes wherein the exposed end of the tissue treatment electrode is constituted by a plurality of tissue treatment filamentary members made of an electrically-conductive material the filamentary members being electrically connected to the radio frequency generator by a common electric supply conductor.
22. Apparatus as claimed in claim 21 wherein the radio frequency generator includes control means for varying the output power delivered to the electrodes.
23. Apparatus as claimed in claim 22 wherein the control means is such as to provide output power in first and second output ranges the first output range being for powering the electrosurgical instrument for tissue dessication and the second output range being for powering the electrosurgical instrument for tissue removal by vaporisation.
24. Apparatus as claimed in claim 23 wherein the first output range is from about 150 volts to 200 volts. and the second output range is from about 250 volts to 600 volts, the voltage being peak voltages.
CA002241662A 1996-01-09 1997-01-09 An underwater electrosurgical instrument Abandoned CA2241662A1 (en)

Applications Claiming Priority (4)

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GB9600377.7 1996-01-09
GBGB9600377.7A GB9600377D0 (en) 1996-01-09 1996-01-09 Electrosurgical instrument
GB9612996A GB2308980A (en) 1996-01-09 1996-06-20 Electrode construction for an electrosurgical instrument
GB9612996.0 1996-06-20

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JP (1) JP2000506405A (en)
AU (1) AU719565B2 (en)
BR (1) BR9706969A (en)
CA (1) CA2241662A1 (en)
DE (2) DE69734848T2 (en)
WO (1) WO1997024994A1 (en)

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DE69734848T2 (en) 2006-08-17
EP0873089B1 (en) 2003-10-22
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US6015406A (en) 2000-01-18
DE69725699T2 (en) 2004-07-22
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EP0873089A1 (en) 1998-10-28
WO1997024994A1 (en) 1997-07-17

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