CA2209248A1

CA2209248A1 - Expandable multifunctional instruments for creating spaces at obstructed sites endoscopically and methods therefor

Info

Publication number: CA2209248A1
Application number: CA002209248A
Authority: CA
Inventors: Inbae Yoon
Original assignee: Individual
Current assignee: Individual
Priority date: 1995-01-06
Filing date: 1995-12-29
Publication date: 1996-07-11
Also published as: US5823947A; EP0805699A4; AU4739796A; US6120437A; US6146401A; EP0805699A1; US5865802A; JPH10511589A; WO1996020749A1; AU712851B2; AU2700899A; US5800394A

Abstract

An expandable multifunctional instrument (10) for creating a space at an obstructed site in the body includes an elongate member (12) having a distal end (20) for being introduced in the body, a proximal end for being disposed externally of the body, and an expandable member (16) for being positioned at the obstructed site. The expandable member (16) is movable at the obstructed site from a non-expanded position to an expanded position to displace anatomical tissue to create a space at the obstructed site for performing various operative procedures. A method of creating a space at an obstructed site includes expanding an expandable member (16) at the obstructed site, and/or introducing fluid under pressure at the obstructed site to create a space where normally no space exists.

Description

W 096/20749 ~CTAJS9~tl6396 Expandable Multifunctional Instruments for Creating Spaces at C~bstructed Sites Endoscopically and Methods Therefor BACKGROUND OF THE INVENTION
Field of the Invention:
The present invention pertains to minimally invasive surgical procedures and, more particularly, to methods and instruments for creating operali,)g sp~ces to facilitate the pe, ~r",ance of minimally invasive surgical procedures.

Discussion of the Prior Art:
Endoscopic or ",i"i",ally invasive surgical procedures have become well ~c~e,~3d due ~o the reduced trauma and recovery time for the patient as well as the ~550~ lec dea~ase in hospil~ ;u,, time and cost. It is desirable to expand the types of proced.lres that can be pelrolll~ed using minimally invasive ~ techniques; however, for such procedures to be universally acce,oted, the procecJures must be capable of being pelfurmed in, at most, the same time required for th~ same procedure perro"~ ~ed by open surgery and must be capable of being ,ue~ fu~ med by su,geons of varying degrees of skill.

_ _ _ _ _ _ _ _ _ _ _ _ _ _ 096/20749 PCTrUS95/16396 There are many areas of surgery to which it wouid be desirable to extend minii,~ally invasive tecl",iques and one such area is the l,eal",enl of tissue disposed at po, lio"s of the analo"~/ other than in cavities providing sufficient space to pe, rO" ,~ ~rocedures such as, for exd" "~IE the aL,(JGr"e" and thorax. The terms "tissue" and "organ structure" are used herein synonymously and include portions or the enlir~lies of all analor"icdl parts. Ex~r"~lcs of such areas of treatment include for exd",ple preperiLo"eal hernia repair, bl~dder neck suspension ~ io" or biopsy of masses or tumors within a,)alor"ical parts such as the breast or the brain and the like. When procedures are peirormed in cavities such as the abdol "en conventional rel, aclors or other tissue marip~ ors can nG, 1 l lall~ be used for eYpos~ ~re of tissue to be treated; however where the tissue to be treated is loc~ted in obstructed andLol"ical sites such as in very small cavities in potentiai cavities such as between layers of anatomical walls in non-layered tissue or in a single layer of tissue visu~li7~tion of the operative site is obstructed as well as is space for maneuvering instruments making minimally invasive surgery extremely difficult to perform in an acceplable manner. As used herein, the term "obstructed site" refers to a"alo,nical sp~ces or cavities of such a small size that procedures cannot be vis~ i7ed and/or ~e, ro""ed as well as a"-dtor":--' loc~tiu, ,s where no space or cavity exists. In the ~ -latter case the obstructed site incl~ ~des ",uotential sp~ces or cdvities", such as between layers of andlor"ical wall that can be separaled or sp~ced such as the peritoneum fascia and muscles of the abdo",inal wall and the epidural sp~ces ~; bet~//cen the dura matter and the brain and spinal cord between tissue structure that is "o" "ally closed or collapsed as well as localions within hûmogenous tissue :

,i W 096120749 PCT~US95/16396 that is not separable on a layer-by-layer or CGI ,sliluent basis such as the breast the brain and the lung.

SUMMARY OF THE INVENTION
Accordingly, it is a primary object of the present invention to facilitate minimally invasive ,u(ucedures peiro""ed at obstructed a"dlu",ical sites by creating operal ing sp~ces ~ cent tissue to be treated.
Another object of the present invention is to create an operating space adjace,)t tissue to be treated allowing procedures to be carried out by single puncture techniques as well as multiple puncture techniques.
A further object of the present invention is to encircle tissue to be treated with an ex,..andable member to create an operating space adjacenl the tissue to be treated.
An add tional object of the present invention is to utilize a plurality of sp~ l. expe~"dable members to create an opereali"g space for treatment of tissue at an obstructed anatomical site.
The present invention has an ad-l;tiul ,al object in that ~peraling sp~ces are created at obstructed ane~lo",ical sites by exlJea,ldatle members remaining in place during mnimally invasive pr~cedures such that insufllation of the space can be accomplished but is not required.
In accordance with the ,c,t:senl invention operating sp~ces are created at obstructed a"e~o"lical sites with the use of ex~ andable ",e" Ibers rO""ed by fluid expansible or dislensible me"lbreanes or balloons mechanically ex,uandable devices such éas artic~ teC] arms or spines returned to a prerorlned shape upon 096/20749 PCTrUS95/16396 release of conallaints thereon and/or absor6ent ",alerials ex~a"dable upon absor~Jtio" of fluids. r, erera61y the outer surfaces of the expandable r"e"~bers are covered with an absG, 6ent material to permit removal of body fluids such as blood from the operali~/e site to e, 1l Idl ,ce vis~ tion. AddiLionally as ~lisclosed in the prior applicaliol ,s aspi, dlion of fluids from the absor6ent material can be accomplished while the expandable members remain in place. By arranging plural ex~.a, Idable " ,e" ,bera in spAced relation, the space between the ~A~,andable " ,embera can define the operating space, and the distance between the ex~.andable ,llem6ela can be adjustable by the use of collars, or by mounting the expandable members on telescoping or sliding tubes both disclosed in the prior applications. By shaping the expandable melllbera to form an opening or channel therein the tissue to be treated can be exposed by positioning the expandable rllell~bers such that the tissue is located in the opening.
The expandable ~embera are constructed in accordance with the tissue in which an operating space is to be created including the angular oriel llaliGI, of the e~"dabl~ member relative to the longitudinal axis of the instrument and the e;~dl laion means. Where prerurmed spines are used the ex~a"dable members ~ ' are p~ ~r~,~bly flat when introduced such that the spines maintain a predeter" ,i"ed - shape during positioning of the expandable members and the e~Ja,)dable -~' members are theredrler il,rldled. The use of a toroid or doughnut shape is particularly advant~geous as are multiple finger shapes with openings derille.l - between the fingers.
:;
- Other objects and adva"lages of the present invention will become apparent from the following desc,i~tion of the prefe"ed e"~bGdl",ents taken in .:.
-conjunction wi:h the acco",panying drawings wherein like parts in each of the several flgures are identified by the same reference characters.

BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 i9' a broken side view of an expandable multifu"ctiGnal instrument according to the present invention.
Fig. 2 s a broken side view partly in sectiGn of the expandable multifu,,~:liu,,al instrument of Fig. 1 with the outer member in a rel,acted position and the expan~iable member in an e,c~ a"ded position.
Fig. 3 is an exploded side view of the inner member and the ex~.a,1dable member for the ex~.&ndable multifunctional instrument of Fig. 1.
Fig. 4 is a broken perspective view of the expandable multifunctional instrument of Fig. 1 introdl ~ced at an obstructed site in analo",ical tissue.
Fig. 5 i~ a broken perspective view of the expandable multifunctional instrument of F ig. 4 c(ealing an initial space at the obstructed site.
Fig. 6 is a broken perspective view illustrating another method of creating a space at an obstructed site in analo",ical tissue showing fluid under pressure being introduc~d at the obstructed site.
Fig. 7 is a s~l,e".alic view of a directional control system for the e~anclable multifiJnctio~ ,al instrument of Fig. 1.
Fig. 8 is a broken per~pec~i~/e view of the expandable multifunctional instrument of Flg. 1 illu~ alil ,y use of the directional control system to adjust the angular orie, ,laliûn of the ex~.ar,daLI_ " ,e" lber.

~ CA 02209248 1997-09-16 - W 096/20749 PCTrUS95/16396 Fig. 9 is a broken side view partly in section of a modification of an . ~ expandable multif~" ,ctio"al instrument accG,ding to the present invention.
Fig. 10 is a broken side view of another lliodiricalio" of an ex~a"dable - ~ multifunctional instrument accordir~g to the present invention having an eA~andable ",e",ber defining a multiple finger shape.
Fig. 11 is a broken side view of a distal portion of a further ")odiricalion of an ex~,andable multifunctional instrument according to the present invention -. having an expandable member defining a three finger shape.
Fig. 12 is a broken side view of a distal portion of an add;tio"al modification of an expandable multifunctional instrument according to the present invention having an ex~andable member deri"i"g a four finger shape.
Fig. 13 is a broken side view of a distal portion of another modification of an expandable multifunctional instrument according to the present invention having an ex~andable member defining a five finger shape.
Fig. 14 is a broken side view of a distal portion of yet another modiricaLion - = of an ex,ua~ ,dat.le multifunctional instrument according to the present invention having an ex~a"dable member defining a curved J-shape.
- Fig. 15 is a broken side view of a modiricalion of an expandable ",e",ber - according to the presenl invention having a fan-like spine.
- Fig. 16 is a broken side view partly in section of a further modification of an ex~ andable multifu"ctional instrument accordi,)y to the ,urese,,l invention ~; having an ex,ua,-dable rne"~ber defining a C-shape.
~ , , ~ 6 . .

.. ~

W 096120749 PCTAUS95~16396 Fig. 17 is a broken side view partly in se~io~" of a distal portion of an additional Illodi i~alion of an expandable multif~,l,ctio"al instrument according to the presenl invention having an exuand~ble member ~kl :f~ ,ing a toroid shape.
Fig. 18 is a broken perspec1i~e view illusllaling a portal sleeve being introduced at an obstructed site in an analGmical wall.
Fig. 19 is a broken perspective view illustrating the expandable multifull~tional instrument of Fig. 17 introduce~ through the portal sleeve of Fig.
18 to create an initial space at the obstructed site.
Fig. 20 is a broken per~pe~i~e view of a distal portion of another ~"~Jific~lio" of ~n ex~andabl~ multifun~Aio,lal instrument accordi"g to the ~,rt:se"l invention.
Fig. 21 is a broken perspective view of a distal portion of a further ",~irica~ion of an e~andable multifu~cliol~al instrument acco,cling to the ~ senl invention.
Fig. 22 is a broken perspective view of a distal portion of yet another rnodiricalion of an ex~.andable multif~" Ic1io, lal instrument accordi, ~9 to the present invention.
Fig. 23 is a broken side view of a further modification of an ex~andable multifunctional instrument accorci;ng to the present invention.
Fig. 2~ is a broken perspective view of the inner member for the expandable m Jltifunctional instrument of Fig. 23.
Fig. 25 is a broken side view of the ex,ua"dable multifunctional instrument of Fig. 23 illus~rating the outer me,nber in a relracted position.

-.CA 02209248 1997-09-16 W 096/20749 PCTrUS95116396 Fig. 26 is a broken per~pec~ e view illu~ll aLil)g the ex,~.a, Idable multifu"clio"al instrument of Fig. 23 introduced at an obstructed site in an a"alo",ical wall.
Fig. 27 is a broken perspective view illusl~ali"y the ex~.andable me"lber:
of the ex~andable multifunctional instrument of Fig. 26 in an e~c~.a"ded ~osilion , . .
to create an initial space at the obstructed site.
Fig. 28 is a broken perspective view illuslldlilly the expandable ",er"bers of the ex~,andable multifunctional instrument of Fig. 27 creating a second larger space at the obstructed site and an additional portal sleeve placed in communication with the second space.
Fig. 29 is a broken perspective view illustrating an instrument introduced through the ~dditional portal sleeve of Fig. 28.
Fig. 30 is a broken side view of a distal portion of another modification of an expandable multifunctional instrument accordi"y to the present invention.
Fig. 31 is a broken side view of a distal portion of an addilio,lal modification - ~of an expandable multifunctional instrument according to the present invention.
Fig. 32 is a broken perspective view of a distal portion of still a further modification of an expandable multifu, l~tiGI ,al instrument according to the present invention.
-Fig. 33 is a broken per~pecti./e view illusl,aling use of the ex~,andable multifu"ctiGnal instrument of Fig. 17 in preperilol,eal endoscopic direct hernia repair.

r :- 8 :
.

W 09612074~ PCTAUS95J1639 Fig. 34 is a broken perspective view illustrating use of the ex,uandable multifunctional instrument of Fig. 22 in inlr~eriloneal e"dosco~ic direct hernia repair.
Fig. 35 .s a broken perspective view illusl,ating use of the expandable multif~."~ional instrument of Fig. 32 in extraperitoneal e"dosco~L direct hemia repair.
Fig. 36 is, a broken side view of a distal portion of a further rlludiri~liun of an ex,u~ndable multifunctional instrument according to the present invention.
Fig. 37 is an exploded perspective view of another modification of an ex~.andable multifi,,)ctional instrument according to the presenl invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS
An expandable multifunctional instrument 10 accord;ng to the present invention, as Illustrated in Figs. 1 and 2, incl~es an elongate inner tubular .,e..~ber 12, ar eh. ,ydte outer tubular me"lber 14 co"cent, ically ~is~osed around inner tubular member 12, an ex,uanda~le member 16 and a hub 18 mounting a pr~xi.,)al end af inner ,ne"lLer 12. Inneml,amber 12 can be made of any sl-it~hle rigid, semi-rigid, flexible or benddble medical grade material, such as metal or plastic, and can have any desirab.le cross-sectional configuration including cyli. ~dl ical or ~ubular configur~tions in accordanca with proced.lral use. Inner ~,~el,lber 12 can be ~;l.ai.Jlll, can have a pradeter",ined, curve, bend or angle or ~ can be selectively bent, angled or curved during use as ex~Jla;. .ed further below.
Inner l"e"lber 12 includes a distal end 20, a p~uxi~al end mounted to hub 18 and ~- CA 02209248 1997-09-16 =~ W 096/20749 ~ PCTrUS95/16396 . .' - a lumen or internal p~ssage exlei.Jing longitudinally between the distal and proxill~al inner ",ei"ber ends.
~anddble ",e"lLer 16 for instrument 10 as shown in Fig. 3 is carried at the distal end 20 of inner ",e",ber 12 and is formed of one or more layers of - -~ ",dlerial configured to define a body, envelope or bag having a closed distal end 24 and an open pr.,xi",al end 26 secured to inner ",e",ber distal end 20 with the -I inner member lumen in comm~",icalion with the interior of the ex~al)dable . .
",er,lber. The e~ anclable member ,vroxi,,,al end 26 can be secured to the inner- member 12 in many various ways including adhesively or with the use ofl"e~)dn ~i seals. The ~ ruxi",al end 26 of expandable member 16 is formed as r a tubular neck configured to fit closely over the distal end 20 of inner member 12 -- for sea~ r"e, ll thereto along a peri~herdl or circu,nrerenlial seal to form a sealed or fluid-tight envelope. Ex~andable ",er"ber 16 is movable from a non-ex~,anded - - - or c ~psecl position, shown in Fig. 3 allowing the ex~d~ ,da~le ",e",ber 16 to be '- received in outer ",e",ber 14 to an expanded position shown in Fig. 2 rO""i"g - an enlargement or protrusion at a distal end of instrument 10. The ex~Ja,ldable ,, -- member 16 can be made of an expandable, distensible, collapsible flexible resilient ~I,etcllable or elastic material such as medical grade silicone or latex .
rubber or sponge, or of a non-elastic non-sl,etc;l,able material such as plastic.
rlef~l~Lly, the e~andable ~e"lber 16 is made of a tearing or breakage-resislant material and is l,anspare"l to permit vis~ tion through the ~,ate,ial of the -- e~andable " ,er, lLer. The e~a"dable mer,~ber 16 can have any des;rable cross-~~ seclional configuration including various predeter",;ned or prero~ ed sl,apes.
- Expandable member 16 for instrument 10 is in the nature of a continuously =

' ; = . .

WO 96120749 PCr/17S95/16396 expandable or inflatable balloon or me"~brane made of sl~etcl~able elastic ",d~erial having a p~det~"~lined or prefo~ ed triangular configuration in side view in the ek,uanded posilion. The ex~.d"Jable member 16 can have various configurations in end view as . Ii5r.~0sed in prior ~ppli~l;on Serial No. 08/249 116.
A layer ,.,~",br;~ne or body 22 can be carried by the e~ar,daL,le ,nember 16 such as along all or part of the eAIe" ,al surface thereof as shown in Fig. 2 or within the e~ar,dableme~Tberasdesuibe~ inprior~ppli~-~l;ol,Serial No. 08/249,116. The layer or ",a"~b~a,le can be pe"nanenLly or removably or separably attached to or carried by the expandable member; and where removable or se~,d,dL,le the ~e"lbrc" ,e can be applied by the instrument to tissue structure or delaul ,ed from the instrument to be left in the body. The layer 22 can be formed of abso~ I~ent male,ial as disclosed in the prior application. The mer,lbrane 22 can be ror"~ed of or contain an anti-co~gul~ting or anti-adhesion agent or a co~gl ~ ing agent it being noted lhat me",br~"es conLaining co~glJl~ting agents normally dissolve in use whereas ,ne"lbra,)es conlaining anti-co~g~ ting agents normally do not dissolve in use but can be absorbed by the body. An example of a ",e",brane containing ant.-co~gu~ ng or anti-adhesion agents is Interceed marketed by Johnson & Johnson Medical Inc. of Allinyloll Texas. Examples of me"lb,d"es containing coagulating agents include Surgicel and Instat marketed by Johl~scil, & Jol ")son Medical Inc. of Al lington, Texas and Avitene marketed by Med Chem Products, Inc. of Wobum Massa~ ,usetts. The Illell~lJldl ,e can carry medica",e, lls such as antibio~ics and ~e" ,c~tl ,erape~ ~tic agents as well as any other agents for applic~ion to tissue.

W 096/20749 PCT~US9~/16396 ~ . .

- - Hub 18 can be made of any desirabie materiai such as plastic and can have any desirable configuration including a truncated triangular or conical configuration to facilitate grasping by a surgeon. If desired the configuration of hub 18 can be selected to cor,espG"d to a predetermi,)ed configuration of ~and~ble . "e" ,ber 16 in the e~a. ,decl posiliGn. A longitudinal pAcsage exte"ds - through hub 18 for receiving the prox;"-al end of inner ",e",ber 12 and the inner ;--"~er,Iber 12 can be pe", Idl ,erltly or removably secured to hub 18 in many variousways such as adhesively or with the use of threaded co"ne~ions. An inlet tube or conduit 28 extends into or communicates with the longitudinal passage of hub 18 from externally ll1e~or to communicate with the lumen of inner member 12 providing a working or Gperali"g channel through the instrument. Inlet tube 28 terminates proxi, nally at a Col " ,eclor 30 for being coupled with a source or supply of fluid. A valve 32 such as a stop cock communicates with tube 28 for corlt, ~II;ng the flow of fluid to and from expandable member 16. Valve 32 can be desiy"ed in many various ways to permit instruments to be introduced through the working channeJ to close off or seal the working channel when no instrument p~sses therelhrough.
Outer me mber 14 can be made of any desirable medical grade materials including metal or pl~stic with sLfficient rigidity to ~"ainlai,. the e~,udn-lable ..e.nber 16 in a collarsed or non-expanded posiliGn when the ex~andable ,.,ember 16 is disposed in the outer member 14. Outer "~e,.,ber 14 has an inner diameter or size to receive the inner member 12 while per"~illing relative ..
-movement of the inner me,.~ber 12 and/or the outer r"ernber 14. Outer member 14 terminates distally at a distal end 34 and pro3~i"~ally at a knob or flange 36.

,.~

W 096/20749 PCTrUS9Stl6396 t~ob 36 can ha~e any desired configuration to facilitate y(dSpin~a thereof by the hand yl~a,c;. ,~ hub 18 to move outer member 14 relative to inner member 12. As shown in Fig. ', knob 36 has an enlarged annular configuration with ridges or grooves ll ,er~:on to e nl'ldl ~ce yrasp:ng. Outer member 14 for the instrument 10 is slidably disposed on inner member 12 for movement betw00n an e~le"d~.l posi~ion, shown in Fig. 1, wherein the ex~ualldable member 16 is disposed within the outer member 14 to be l"ai"lai"ed in the non-ex~.a"ded position and a retracted position, shown in Fig. 2, wherein the ex~ual,dable member 16 is e~,~,osed for movement to the e~anded position. It should be apprecialed that various handle structure, other than the hub and knob shown, can be coupled with inner member 12 and with outer member 14 for moving the outer n,ember 14 betvl~cn the exl.ended and r~lld~ d po:,iliol ,s and that such handle structure can include various locking l l ,e~;hdn;sll ,s for fixing the relative position of the inner and outer Ill~ bels In instrument 10, the position of the outer n,e,l,ber 14 relative to the inner member 12 is retained by friction.
The instrument 10 as described above is represe"lali~/e of the suhject invention in basic form. However, it should be appreci~ted that various Illo~ ic-~liol IS a~d/or aclditions can be made to the subject invention as explained further below.
In use, he instrument 10 is normally provided with the outer member 14 in the e~ctendeo posilicil I such that the e~c~,anJable member 16, which is norlI,ally provided in the non~dl ,de-J positio, I is ~ ,oseJ within the outer r, lel l ~ber 14 as illus~ at~l in Fi!~. 1. With the outer me,nber 14 in the extended pOSiLiCil 1, the outer ,el,lber distal end 34 will be disposed distally of the inner member distal end 20 ~ CA 02209248 1997-09-16 - W 096/20749 PCTrUS95/16396 a distance that is at least as great as the length L of the portion of e~ andable ",er"ber 16 that protrudes from inner "ler,lber 12 such that no part of e~,udndable ",e"ll~r 16 is e~l ~secl during introduction in the body. With outer member 14 in .
the exle"ded posiliûn and exudndable member 16 in the non-e~ anded pOSiliGn, the instrument 10 is introduced at a potential space at an obstructed site in the body through an endoscopic portal which can be a relatively small size natural or i"..;sional opei~i"g or an instrument channel-such as a portal or trocar sleeve.
Fig. 4 illustrates the instrument 10 being introduced at a potential space at an obstructed anatomical site through the lumen of a portal or trocar sleeve S having a distal end positioned within the body typically via a penel,aliny ,nen~ber d;;,posed within the portal sleeve S and withdrawn therer,u,,, upon positioning of the portal sleeve distal end at the desired location. The obstructed site shown in Fig. 4 is within h omogenous tissue T and is obstructed in that there normally is no space in tissue T for visu~ ol I or for pel rul 1, ling operative procedures. The distal end 34 of outer member 14 is posilio,led at the obstructed site; and once the outer member distal end 34 is properly positioned at the pole"~ial space knob 36 is manually moved pr~xi",ally toward hub 18 as shown by the arrow in Fig. 4 to move outer me,llber 14 proxilnally relative to inner member 12 to the retracted ~ osition. It should be appr~c;dled that depending on procedural use the knob 36 and hub 18 can be ylds~ue-l with a single hand such that inner Illember 12 and outer mel .,ber 14 can both be moved relative to one anotl ~er in a sque~ing action to move the outer me"lber 14 to the r~ld~Aed position. Fig. 5 illusllales the outer member 14 in a fully rel,dc~ed position wherein the outer member distal end 34 is ,lisposed p~u~i"~ally of the exluandable ~e~ber distal end 24 a clislance equal .~

. . ., , _ W 096~20749 PC~AUS95116396 or suL sla, Itiall!~ equal to length L such that the entire or sl ~ s~nlially the entire portion of the e~andable rllelllber 16 that protrudes beyond the inner member is ex~.osed. However it should be ~ppreci ~d that the outer ."e"~ber 14 can be selectively manually moved to various inle""ediate r~l, a~:ted positions between the exter,decl position and the fully, t:ll dcted ~osilion where it is desire.l to exl ~ose less of the e~ucll ~dable r"e" Iber. Prior to moving e)-~,a"dable " ,e" ,L,er 16 from the non~anded posiliûn to the ex~Jdncled posi~iûl, a visu~ irlg instrument such as an endoscû~)e can be introd~ Iced in the lumen of inner ",ember 12 via inlet tube 28 to position an image receiving distal end 13 of the endosGope E within the e~ar,ddble member 16. Accordingly the position of exudllddble member 16 at the obstructed site can be conrir")ed visually prior to creation of the operaling space.
To creal* an oper~ling space at the obstructed site utilizing the instrument 10 fluid is sl Ir~l PC~ to the interior of exuandable member 16 through inlet tube 28 and the lumen ~f inner member 12 to move the e~,andable member 16 from the non-expanded position to the expanded position as illusl,d~d in Fig. 5. By controlling fluicl flow to and from ex~,d". able member 16 the size of exuandable member 16 in lhe ex~udl ,ded posiliu" can selectively be made larger or smaller in accorddnce with the size of space desired to be crealed and depe"di"y on pr~ced.lral use. Movement of ex~andable me" ,ber 16 to the e)~,UdlldedlJO5i~iOn causes an iniDial space S' to be created at the obstructed site due to pushing spl ce" ,enL ~ilatation ( li~sectio" or retraction of tissue by e~c~,andable r"el "ber 16. The initial space S' can be enlarged if nec~ss~y by moving the instrument 10 such as back and/or forth in a longitudinal direction as shown by the arrow in - W 096/20749 PCTrUS95116396 . ~
, . .. .
- Fig. 5, to further retract, ~lissect, separ~le or move the tissue T to create a second space s2 shown in dotted lines, and the initial and second sp~ces can be credled = . , .
under direct visu~ lio" by encloscope E.
Accordingly, the instrument 10 allows an actual operati"g space to be created from a pote"lial space at an obstructed site for visu~ tion and/or .
lreal",el,t of ~ljacent tissue and to permit various procedures to be pe,ror"~ed utilizing the thusiy created o~,erali"!a space. The pl~s~nl invention allows an operaling space to be created with a two-step ~rocedure whereby a small initial - space is created at the obstructed site for visualization and, upon visual . .
couril~ldlion of proper location of the initial space, a second larger space is created from the initial space to provide the room needed to perform various operalive procedures. By providing direct visl~li7~tion via the initial space, connecli~/e tissue structure can be cut, if necess~-y, under direct visualization to permit separation of the tissue to create the second, final space. Additionally, if the initial space is improperly lo~te~l. the proper location can be found without a larger final space already having been formed.
The instrument 10 can remain in place to ~l~ainlain the operating space , -, and/or to manip~ te tissue. The instrument itself can define an oper~li,lg or , ., working space within the ex~dl Idable ~llenlber via which various pro~dures can be pe,ror"led. Where the instrument remains in place, the instrument can be utilized to recreate the operating space in the event that the operali"y space collapses or is lost. The expandable Illel~lber 16 can have a p~ssa3e , .
ll ,ereU u ough as explained further below to allow fluid and/or various additional - instruments to be intro~luce~ at the o~ er~ling space. Although instrument 10 is ~ 16 , 7 _ .
'- '' !
_ _ _ _ W 096/20749 PC~US95/16396 illustrated in conjunction with a single portal, it shouid be a,c~,reci~ d that addilional port~ls can be placed in communication with the operaLi"g space for introduction of various instruments in multiplerpuncture proced.lres.
Subsequent to creation of initial space S', the second larger o~,~rali"5a space s2 can be crealed in various ways other-than and/or in addilion to moving the instrumen~l 10. One way of creating space s2 is by introducing insufflation fluid under pressure at the initial space S'. Slliphle fluids include CO2 N O, ~lisl;lled water, saline high density ~luc~se such as Hyscon Dextran lransparel~t medical grade jelly or viscoelastics such as Hilan. The insufflation fluid can be introduGed through sleeve S, enJosco~e E, instrument 10 where the instrument is provided with a l.~ssage or through a second portal in muitiple puncture ,~.roced,Jres. Another way to create space s2 is by introducing another e~.~"dable multiful l~tiU~ ,al instrument at the initial space S' through the p~ss~ge of instrument 10 or a second portal. Where the instrument 10 is withdrawn from sleeve S s~ ~hse~uent to crealio,- of the operating space the operating space can be maintained by introducing insufflation fluid, particularly Dextran or jelly, at the o~erdli, Ig spa~ e.
The si;~e and configuration of the space created with the expandable multifunc1iGnal instrument will depend on the size and configuration of the e~andable ""~,nber in the e~anJed positiGn and on the nature of the analo",ical tissue at the obstructed site. For example, in some cases the a"a~o",:-~ l tissue ~ will s~ ~-sl~nlicllly conror", to the ex~.a"Jable ",e"~6er in the e~,anded ,~.osilion such that a space co"es~ unJing s~ l.s~ntially in size and shape to the e~dl ,dable member will be formed, whereas in other cases a space larger in size W 096/20749 PCTrUS95/16396 ~-' than the ex~.anclable member will be for"~ed due to separalion of tissue layers.
. Depending on the nature of the tissue the instrument can be moved from e,.ler"ally of the body to gently manipu!~tQ cor" ,ecli~/e structure of the tissue to permit the tissue to be se~,araled to facililate crealion of the operaliny space.
- Various fluids can be utilized to move the e~andable ."e"~ber between the non-ex~d"ded position and the expanded position including the various insufflation fluids desa ibed herein. r, ere" ed s~ l~st~ .ces include Dextran high .
viscosity gels and other substances that are immiscible with blood such that : ~ visibility is not obscured in the event that the expandable member bursts in the - body as it would be in the case of immiscible S!lh5l~nCeS such as saline. Where -- all or part of the expandable member 16 is covered with the layer of absorbent ~-~ material 22 or formed of absorbent material the abso,L,enl mdlerial can be utilized to absorb or collect bodily fluids, such as blood. The ex~a"dable member ;: 16 and/or the absorL.e"l material 22 can carry various co~gul~ting anti-, ' 5 .
coagulating a, .liLiJlic and ll ,erapeutic sl Ihst~rlces. The outer surface of ~- expandable ",e",ber 16 can be irregular or rough to co"lacl and/or treat a"alo",ical tissue depe"ding on ~,roced.lral use. Various visu~li7ing devices including el)doscopes and charge coupled devices can be utilized for VjSl,lAii7AtjOn.
In acco,da"ce with a modification of the Illelllod ~Jesc~ibeJ above insufflation fluid is introd~ ~ced or injected at the obstructed site to create the initial --~ space S' prior to introduction of the e~a"Jable multifu"~ tional instrument or prior ~ .

,G~-- to movement of the ex~,anclable multif~ tional instrument to the expanded position. The fluid can be introiuced at the obstructed site through portal sleeve ..
.. 18 ~ ' ,, i S, the expancable multifun-;lional instrument or through another instrument or portal c ommunicating with the obstructed site. Many various instruments can be utilized to intro~uce or inject fluid under pressure at the obstructed site including ne,~dles, Tuohv needles, safety needles, Verres needles and s~andard and safety llOc~la with pressure syringes or pressure pumps with gauge in~ ur~. Fig. 6 illustrates flukl F being introducecl at an obstructed site within breast tissue TB
through portal sleeve S to ~lisplace tissue TB to create initial space S'. Creation of initial space S' in the ~esi,t:d loc;dlion can be co"ri""ed visually via eudoscope E intro~uced through the portal sleeve S or through a seco"d portal in multiple ~ puncture tech1iques. To create the operating space S2, the instrument 10 is introduced at the initial space S' through the portal sleeve S, through the instrument us~d to introduce fluid, through an additional portal communicaling with initial spac~e S' or through the endoscope E where the endoscope E has an operali"g channel. The ex~ and~ble member 16 is exposed in or ~ cent the initial space '-i' and is moved to the e~.~,anded position as described above to create operdliflg space S2. The methûd of creating sp~ces at an obstructed site by introducing fluid at the obstructed site is particularly useful in organ structures and procedure s including the breast, lungs, brain, structure ~lj-cent embolic or anuretic arteries or veins, retroperitoneal sp~ces, various layers of the spinal cord, preperi~oneal sp~c,es for ventral hernia or inguinal hernia repair, s~ neous tissue such as pr~cedures involving the removal of ganglia, benign lumps or meli~noma, bowel or bowel wall, liver, spleen, pancreas, kidney, gall bl~1~1er, uterin ~ wall, the spaoe of Retzius utilizing liquid injection or introdoction, pathologic~l Ic.~cations and localions ~5~c-e"t pathological localicjns.

~ CA 02209248 1997-09-16 ., .
~ W O 96/20749 PC~r~US9S/16396 ; ..' Some of the various IllodiricaLions that the ex~,ar,cJable multifu"c~ional instrument 10 can have include a spine 40 and a directional control system 42.
Spine 40 as illuslraled in Fig. 2 can be disposed inside of ex~.andable me"ll,er 16 within the ."dlenal forming ex~,~r,dable member 16 or o~tside of ex~andable .n~mber 16 for shaping rigidifying and/or ex,uanding the ex~andaLla member 16.
Spine 40 is disposed within ex~anda~le member 16 and incl-~des a plurality of arms 44 having ~roximal ends connected to the distal end of inner ..,e",ber 12 and distal ends joined to inwardly bent or angled fingers 46. Fingers 46 are bent or angled from arms 44 in the direction of a longitudinal axis of instrument 10 to ter",;,)dle at rounded nubs 47 forming a sr"oolll profile or surface configuration for expandable member 16. Spine 40 has a preror",ed triangular configuration in side view with arms 44 biased outwardly in a direction away from the instrument longitudinal axis to bias the ex~a~ Idable member 16 to the eA~anded position and the spine has a flat configuration in end view with arms 44 aligned with one anolher. Arms 44 are movable inwardly in the direction of the longitudinal axis of instrument 10 to permit e~andable me"~ber 16 to be moved to the non-expanded position. Various ",dl~rials including various spring ",alerials such as metals or plastics can be utilized for spine 40 and it is desired that the spine 40 have sufficient rigidity to maintain the shape of ex~anc3abl~ " ,e" ,ber 16 in the eA,uandecl posilion and to permit manirl''~tion of a"alo"lical tissue.
The dir~lional control system 42 is illustrated in Fig. 2 and sche",alically in Fig. 7. The directional control system 42 is for use with a flexible or partly flexible or bendable inner l"el"ber having at least a flexible distal end portion.
The directional control system 42 incl~des left and right control wires 48L and 48R and up and down control wires 48U and 48D exlencJi"g longitudinally along inner ~"e" Iber 12 and having distal ends connected with the inner member distal end 20 and proxi",dl ends con"ecled with left and right control wheels 50L and 50R and up an~i down control wheels 50U and 50D res~i-/ely, mounted on hub 18 only the lefl control wheel 50L being shown in Figs. 1 and 2. Winding of one or more of the control wires 48 via rota(ion of the c~r~esponding control whee!s 50 c~!lses correçponding selective angular movement or bending of the inner ~"e"~ber distal end and unwinding of the control wires via rotation of the control wheels causei the inner member to be straightened as disclosed in prior application Serial No. 08/249 116.
Use of instrument 10 having spine 40 and directional control system 42 is similar to that described above except that expandable member 16 is maintained in the non~xpanded position via con:.ll a;, ll of spine 40 by outer ,ne,nber 14 in the ext~"~led position. Movement of outer member 14 to the relracled position r~le~es arms ~4 to aulo,nalically spring outwardly to move ex~andable nnei"ber 16 to the expanded position to create an initial space at an obstructed site with the spine 40 ,naintaining and/or rigidifying-the ex~,a"d~ble member in the e~"ded posilion. Spine 40 can be utilized to move the ex~,a,)dable ,ne",ber to the expanded position mechanically with or without fluidic e,.,uansiG" of the ex,..d,)dable me"lber however in instrument 10 fluid can be supplied to the ex~,an.Jable member 16 as des-;,ibed above to fill out the configuration of the - e~andable member or to further ex,ua- ~d the e~ar,dable ~"el,lL,er 16 to increase the size of the e~ar,dable r"e"lL~er in the expanded position. In order to cl,ange the direction or o, ie, ItdtiCsl I of ex~andabl2 member 16 one or more of the control O 96/20749 PC~rrUS95/16396 .
wheeis 50 are rotaled to move the corresponding control wires 48 to ~;1 ,ange oradjust the angular orie"tdlion of expandable me"~ber 16. For example Fig. 8 illustrates the instrument 10 sl~hse~uent to angular adjusl",enl wherein a longitudinal axis of eA~.andable ",e"lber 16 is angularly offset from the longitudinal axis of instrument 10. As shown in Fig. 8 the outer l~e",ber 14 in the ret,d.;ted posilio,l is moved pro,(i,nally a di~lance sufficient to expose the flexible inner "~ember distal end portion. Alle",dli~/ely, at least the distal end portion of the outer member 14 can be made flexible or bendable such that the outer member distal end 34 can be aligned or 5l~hst~r,lially aligned with the inner ,nel"ber distal end 20 in the retracted position while per",illing angular adjustment. Fig. 8 illustrates the up control wire 48U exter,ded or advanced in the direction of the cor,t:sponding arrow and the down control wire 48D wound or relldcled in the direction of the corresponding arrow to move the inner member distal end portion angularly downwardly and the control wires can be utilized toartic~ te the expandable me",ber angularly. It should be appreci~t~d that angular movement of the expandable ~el~ber can be utili~ed to create a space at the obstructed site by (ell a~;ting or manipulating tissue. Instrument 10 having spine 40 is withdrawable from the body s~lhse~uent to release of fluid from expandable ",ember 16 and/or movement of outer ~ember 14 to the extended posilion to cGnsll ain spine 40.
Various spines can be utilized in the ex~..andable multifu"otional instruments of the present invention and the spines can be designed in many various ways to have various diverse pre-leter",;ned configurations in the e~, Ided posilio" including flat and non-flat configurations. The spines can be W 096120749 PC~r~US9SlI6396 des;~"ed as multiple articulating pivotable or jointed arms as ~isclosed in the prior applic~l;o"s. The spines can be allacl ,ed to various cG",ponents other than the inner "~e",ber or the spines can themselves be se~ldl~, independe.,l componenls as desc, ibed further below. The spines can be hollow or tubular to permit inflation of the ex~ua~dable Illelllbera through the spines, and the spines can be used for il l iyalio, I aspir~lio, I or cJI ainage and/or for supplying ",~ica")e,~ts. rhe spines can be n tili7P~l to rigidify the ex~uandable ",e"lbe,a for use in manipul~ting organ or tissue structure.
The expandable multifunctional instruments can be designed in many various ways tc provide the ex~.d. .dable members to be normally disposed at an angle with the instrument longitudinal axes. For example inslead of the directional control system any one or more of the inner ~el~ber the outer member or the spine can include a resilient flexible bendable or clefo,mable seg"~enl or nec~ having a pr~dele", lined bend curve angle or shape " ,er, ,OI y to normally position or bias the ex,~.anda61e member to a position where the longitudinal axi~ of the ex~.andable "~e"~ber is offset from the longitudinal axis of the instrument ,3S des~ ibed in prior application Serial No. 08/249 116. One way of forming the seyl "e, d or neck is as a spring segment such as a length of coiled wire having a precleter"lined bias or shape ",e"~o,y.
Fig. 9 i lustrates at 110 a modiri~lion of an ex~,a".lable multifu,!~;tional instrument accord;ng to the ~.rese"l invention having a hollow spine 140.
Ex~.andable multifu"ctio"al instrument 110 includes tubular inner member 112 outer ",el,lL,er 114 and e,~ar,dable ",ember 116. E~,al ,dable r"e"~ber 116 has an open distal end 124 connected to the distal end 120 of inner ~"el.,ber 112 at :

-- W 096120749 PCT~US95/16396 a circu",rerer,lial seal and an open pro~i",al end connected at a ciru,mrerenlial seal to a cyli"dl ical rioublc walled body 156 of spine 140. Inner n ,e"~ber 112 is ~1; ,posed within the cyli"dl ical body 156 and protrudes distally ll ,e, er, u, n such that the inner member 112 forms a central working or operaling l;l,annel through e~dndable ",er,~ber 116 for introriuction of fluids and/or instruments. Spine 140 inciudes tubular or hollow arms 144 c~- "~e~ Led with body 156 which has an inner circul,~~r~"lial wall 158 and an outer circu",r~r~"lial wall 160 sp~d from inner wall 158 to define a pAss~ge 162 therebetween commu. .icaLi. ,g with the inlerior-~of arms 144. Arms 144 are disposed within expandable member 116 with holes or apertures 164 in arms 144 providing fluid communication between p~ssage 162 and the interior of expandable member 116. Inner member 112 extends entirely - through hub 118 which has a truncated conical or triangular profile in side view to te,..,inaLe at valve 132 controlling opening and closing of the inner r~e"~ber lumen. Body 156 exte, IdS into hub 118 and supplemenLal inlet ports conduits or pACs~9es 180 extend transversely through hub 118 to communicate with passage 162. Vaives 182 are mounted exte" lally along hub 118 or within recesses of hub 118 for selectively controlling fluid flow through supplel~e~ ,tal inlet conduits 180 and thererulel through spine 140.
- Outer ",e"ll,er 114 temminates pn"~i",ally at a transverse flange 166 having - an exter.~al thread 168 ll ,ereo, l. Knob 136 for instrument 110 has an elongate distally tapeled configuration with a cylind~ ical internal p~ss~ge 170 defined by an inner cylin~;il ical wall having a thread 172 thereon. Flange 166 is disposed in I~Acs~ge 170 with thread 168 in cooperali.~e enga~el~enl with thread 172. Body - 156 extends entirely through the p~ss~-Je 170 and has a transverse flange 176 ~ 24 .

W 096/20749 PCT~US95/16396 mounted in a ecess in an end wall of knob 136 to permit rotation of knob 136 relative to the pine 140.
Operation of instrument 110 is similar to that desc~ ibed for instrument 10 except that the outer ~e~ber 114 is moved relative to the inner me~ber 112 between the e;~.le"ded and relldct~d posilions by manually r~lalin~ knob 136.
Fig. 9 illu~lldl~s flange 166 in dotted lines at a distal end of p~-ss~ge 170 at which time the outer nember 114 is in the exter,ded position. Rotation of knob 136 in a first direction of rotation will cause flange 166 via threads 168 and 172 to be moved p(oxi",ally along pA-ss~ge 170 causing cor, eS,uGI Idil Iy pro,~i"~al movement of outer member 114 relative to inner member 112 from the extended position to the relr~cled Fosition shown in Fig. 9. Movement of outer member 114 to the ,~act~d position G~uses arms 144 to spring outwardly to move the expandable member 116 from the non-ex~d"ded position to the ex~dnded position. The ex~,a"dable member 116 can be maintained in the expanded position or moved to a further ex~ nded posilion via il Inatio" through spine 140 in that supplemental inlet ports 180 c an be utilized to supply fluid to the interior of ekpandable member 116 via p~cs~ge 162 arms 144 and holes 164. Various instruments or fluids can be introd!~ced through the operating or working ul,a,)"el defined by the inner ,"er"L~r 112. The instrument 110 can include a penelraling member disposed in the inner " ,e, ~ Iber 112 for pe, lell -ali- ,9 analol "ical tissue to introduce e,~,uandable ",e"~ber 116 at the obstructed site. Knob 136 is rotaled in a second clil-eclion of - rotation to cause flange 166 and therefore outer member 114 to be moved distally toward the exte"ded position causing movement of expandable mei,)ber 'W 096/20749 PCTrUS95/16396 to the non-ex~anded position by cGnsl,aint of spring 140 for withdrawal of instrument 110 from the body.
Figs.10 - 13 illustrate various ,nodiri~lio,-s of ex~,sndable rnultifu".;tio"al instruments wherein the eA~usnddble n,e",bers have multiple fnger shapes - particularly adv&n~geo~s for holding re~,dc~i"g or manir!J'-~ing tissue or organ .
structure. Fig.10 illustrates an exud"ddble multifu"ctiû"al instrument 210 having a generally V-shaped ex,ua,,dable member 216 defining two outwardly angled fingers 217 with a space or opening 219 between fingers 217 for receiving tissue or organ structure. Expandable ",en,ber 216 has a proximal end ~isposed over and co"neuted to the distal end of inner ",e",ber 212 and a recessed end portion con"ec~ed to a distal end 223 of a control tube 225 d;sposed cGncer,l, ically within inner member 212. The pro,~i",al end of inner member 212 and a p,uxi",al end of control tube 225 are mounted to a hub 218 to position the distal end 223 of the control tube distally of the distal end of inner member 212 such that the control tube 225 defines an operdli"~ or working channel through ex~,andsbl~ member 216 communicating with or formed integrally with inlet tube 228. The outer diameter of control tube 225 is slightly smaller than the inner diameter of inner member 212 to define a ",ini",al gap or space 262 therebetween to permit fluid flow between the inner r"ember 212 and the control tube 225. The pro)~:i,nal ends of inner " ,er"ber 212 and control tube 225 extend into hub 218 and s;~l .ple. l ,enlal inlet ports 280 extend through hub 218 and the wall of inner member 212 to communicate with the gap 262 between inner ",e"~ber 212 and the control tube 225 for supplying fluid to the inle, ior of e~ud"dable n~e, nber 216.

W O 96120749 PCT~US95/16396 A spine 240 for instrument 210 includes a pair of arms 244 having proximal ends connected to the distal end of inner member 212. Arms 244 each include a first straight s ~~~" ,enl 245 extending distally beyond the distal end 223 of control tube 225 to ex~tend into a flnger 217 and a curved or U-sll~ped sey",~"l 249 defining a tip of finger 217 and joining a distal end of the first sl,ai~Jht se~",enl 245 to the distal end of a seco- Id straight segment 251 e~lending p, uxi,, ,ally from the curved s~,ne,)l 249 toward the distal end 223 of control tube 225 to terminate at a gently aJrved or angled end portion 252 at the base of ri"9ers 217. The first and second str~ight sey",e"ls 245 and 251 are parallel or s~ st~- ,lially parallel to one another- to define a width for fingers 217 with the first ~LI~i.Jhl sey",e, ILs defining an outer edge and the second straight segments defining an inner edge for ri~,ger-; 217. Spine 240 biases expandable member 216 to the ex,ua,lded position shown in Fig. 10 in that arms 244 are biased angularly outwardly in a direction awayfrom the instrument longitudinal axis to bias ri"gers 217 angularly outwardly. Wlen the ex~a"dable member 216 is r~;spose~l within the outer member 214 w ith the outer member in the extended position the expandable member 216 will be moved to the non-e~c,ud,,ded position due to collarse or constraint of spine 240 by the outer ,ne" ,ber 214. Movement of the outer " ,ember 214 from the e,~te"-Jed position to the retra~ed posiliGn c~ses arms 244 to spring outwardly thusly moving e~andable ",e,.,ber 216 to the ex~ anded posilion aut~",atically, and fluid can be supplied to the e)~a"dable member 216 through - supplemental inlet ports 280 and the gap 262 between the inner member 212 and the control tube 225.

~ = ~

. W 096/20749 PCTrUS95/16396 A " lodiricdliul) of an eA~Udl IdaLle multifu"~ lional instrument acco, clir,g to the sel IL invention is illu~lr~lad in Fig. 1 1 at 310 wherein only a distal portion of the instrument 310 is shown. Instrument 310 incl-l~es expandable n,e",ber 316 defining three distally protruding fingers with sp~ces 319 between the fingers.
E3/~Udl ,ddble " ,e" ,ber 316 is provided without a control or operating ~l ,annel and includes a central or inner finger 317' aligned or s~Jbsl~dially aligned with a longitudinal axis of instrument 310 and two lateral or outer r~ ~yel ~ 317N angularly ll;cposed on opposite sides of central finger 317'. Spine 340 for instrument 310 includes a central or inner U-shaped arm 344' and two lateral or outer arms 344"
coupled with inner member 312. Arm 344' has parallel first and second straight segments 345' and 351' extending distally into finger 317' to te""i"ale at a - curved s~y",ent 349' joining the straight segments 345' and 351 ' and defining a tip of finger 317'. Arms 344"~ which are similar to arms 244, each include a first straight sey~enl 345" extending distally into a finger 317" and a curved seymenl 349N joining a distal end of the first straight segment 345/' to the distal end of a proxi,)~ally exlendiny second straight segment 351" ter",ir,a~ing at curved end portion 352/' a~acen~ inner arm 344' at the base of fingers 317". Arms 344" are biased angularly outwardly in a direction away from a longitudinal axis of instrument 310 to bias ex~,andable member 316 to the expanded position when outer member 314 is moved to the r el, acted position as shown in Fig. 11.
Fig. 12 illuslrdles a distal portion of an instrument 410 including ex~andable ",e",ber 416 defining four fingers two inner ri,~gers 41i' and two outer fingers 417n with spaces 419 bet~rJccn the fingers. Instrument 410 incl- ~des a spine 440 having two arms 444 joined to a body 456 dispose~l in inner member CA 02209248 l997-09-l6 412. Each arrr 444 includes a straight segment 445N extending distally into an outer finger 417 n~ a first U-sl ,aped sey" ,e, ll 449~ joined to ~lraiyh~ seg" ,enl 445 "
and derini"y a tip of outer flnger 417~ and a second U-shaped seylllenl 449' defining a tip of an inner finger 417~ and co~)ne~ed to the first U-sl ,ap~J 5eylln3 by a curved segment 453~. The secGnd U-shaped se!J"~e"ls 449' terminate at curved end por~ions 452' ~ c-ent one another at the base of inner ringer:j 417~
to provide continuity and s" ,ootl " ,ess. Arms 444 are biased angulariy outwardly in a direction away from a longitudinal axis of instrument 410 to move the ex~nclable me~mber 416 to an expanded position automatically when the outer member 414 iS in the relracled position as shown in Fig. 12.
Fig. 13 illustrates a distal portion of an instrument 510 including an e~dn ~: l e rl ,el "ber 516 defining five fingers with spaces 519 ll ,ereL,elween. The fingers defineci by ex~dncJable member 516 include two outer fingers 517" and three inner fingl rs 517'. A spine 540 for instrument 510 incl~ ~des five arms 544, one for each fir ger. Arms 544 each include first straight seg" ~e, lls 545 exlending distally into the fingers U-shaped sey",ents 549 defining tips for the fingers and joining the fir~t straight segments to proxi",ally extending seco"d straight segments 551 ter",i"dling at curved end portions 552 at the base of the fingers with the ex~pllon of outer arm 544" which has a second slraighl segment 551 ~
extending ~ro~i"~ally along an outer side edge of ex~,a"daL,le ",e"lber 516 to te""inale at inner member 512. Arms 544 have a ~,recletermi"ed bias or shape mer"o~ to move the e~d"dable rllelllLJer 516 to the ex~anded posilion shown in Fig. 13 wherein the expandable member assumes an open, hand-like configuration Jvhen the outer member 514 is moved to the rel,acted position.

W 096120749 PCTrUS9S116396 .; , ~: Inner ~"~ ber 512 for instrument 510 has a distal end portion 543 for",ed with a - pr~deter,lli"ed bend or angle to angularly position the ex~ud-ldable member 516 aulolllalically in lesp-,-lse to movement of the outer member 514 to the rel(acted positiG, 1.
Fig. 14 illu-~l,dles a distal portion of an ex~.alldable multifunctional ~ instrument 610 including an elongale cylind~ ical e)~dndable Illeml)er 616 having -~ an elongate spine 640 therein normally assuming a curved J-shaped - configuration when outer member 614 is in the rellacted position as shown.
..
Spine 640 is moved to a substantially straight configuration by the outer l.le,llber 614 when the outer member is moved to the extended position. It should be apprecialed that the spines for the multiple finger- shaped ex~.andable mei l l6ers des~ ibed in Figs. 10 - 13 above can have a predeler~.li, led curve or J-shape as -' described for spine 640 to produce various curved multiple finger shapes. In particular, an ex~andable member having a curved, hand-like configuratiori is particularly useful for pulling the appe~ out from the retroperiloneal space.
The multiple finger shapes illustrated in Figs. 10-13, particularly when curved, are advdnI~geous for grabbing tissue and, in particular, for pulling tissue . ~
'r' aside and holding the tissue out of the way to create a space for operative procedures and for use in ~Yposllre and dissection. The fingers can be I; - individually controllably bent, angled or curved with the use of various directional - - adjusl.. ~en~ means.
- Fig. 15 illustrates at 716 a 1~ l~iri~lion of an eA~.a, Idable member wherein the expandable rllelnber 716 is ~lle~-a,-ically eA~anded via a spine 740 constructed as a fan-like spring plate. Spine 740 includes a plurality of flat arms , . .

; ., wo 96/20749 PCr/US9S/16396 744 having proxi",al ends pivotally coni,ected to one anoll,er in overlappin~
fashion at a joir-lt 754. Joint 754 includes a spring (not shown) rotationally biasing the arms 744 to assume an open fan-like configuration to move the ex~andable member 716 to the ex~,a"ded posilior, as shown. The eJ(~Jc~, ~dable member 716 is particularly useful for ~ ,edli"g an oper~ling space to ~ccess lumps between ~- ~5 ~ceot organs Anothemllo~Jiri~dtion of an expandable multifu"~tio"al instrument according to the present invention is ill- ~l,dted in Fig.16 at 810. Ex~e-~ndable multifunctional instrument 810 incl~ ~des expandable member 816 having a C-sha~ed configuration n the expanded position and formed of two semi-circular expandable member portions 816a and 816b. Portions 816a and 816b have tapered distal ends 824a and 824b sepé.,dled by a space 819 commu-,icali"~ with a central operating or working space 827 defined by the expandable ",e,.lber portions 816a and 816b such that the space 827 is ~ ~isposed within or circu",s~;-ibed by the e~ue-,ndable member. Ex~dnde~ble n,ember po,lions 816a and 816b have losed distal ends and pro~ al ends 826a and 826b secured to body portions 856a and 856b, respectively, of spine 840 to form two fluid-tight envelopes. Boc y po, liul ls 856a and 856b are ~lispose-l in inner member 812 and are tubular or hollow; Body ~, lions 856a and 856b extend longitudinally through inner member ~312 to ter"~indle p,oxi")ally in hub 818 in comm~",icaliG" with su p ple."e"lal inlet ports 880a and 880b respectively. Body portions 856a and 856b are distall~,~ joined to hollow semi-circular arms 844a and 844b respectively curving outwardly in a cJi,ectio" away from a longitudinal axis of the instrument 810. Arms 844a and 844b have inwardly proxi".ally curving distal end ,voiliGn~

:

096/20749 PCTrUS95116396 829a and 829b respectively forming a s,nooli, contour at opening 819 with rounded protuberd"ces 831 a and 831 b exlending into the tapered distal ends of the expandable me,nber pGI lions. Arms 844a and 844b communicate with the lumens of body po, lions 856a and 856b r~spe~ /ely and holes 864 are provided in arms 844a and 844b to permit fluid to be supplied to the inlerior of ex~.a"dable ",e",ber po,lio"s 816a and 816b. Hub 818 has a cyli"-l,ical configuration with an inlet tube 828 communicating with the lumen of inner me" lber 812 and supplemental inlet ports 880 angularly ~isposed on opposite sides of inlet tube 828. The proximal ends of inner member 812 and spine 840 are mounted to hub 818 to position body po, liol ,s 856a and 856b within inner member 812 and arms 844a and 844b within e~d"dable ~ ~ lember portions 816a and 816b respectively.
The outer l"el"ber 814 for instrument 810 has indicia 833 thereon for providing a visual indication of the depth of insertion of the outer member 814 in the body.

Use of instrument 810 is similar to that previously described in that arms 844a and 844b normally assume a semi~ircular configuration to shape or move the expandable ~ember pollions 816a and 816b respectively to the expanded pOSitiOI ~ when the outer me" lL,er 814 is fel,d~d as shown. Fluid can be supplied to one or both of the ex~,an~lable member portions 816a and 816b through spine 840 and supplemental inlet conduits 880a and 880b. The lumen of inner member 812 defines an ope(dlil ly cha"nel allowing fluids and/or various instruments to be introduc~d at space 827 whereby operalive procedures can be pel ron"ed within the space 827. The flexibility of spine 840 allows the expandable me~ber po, lions 816a and 816b to be moved toward or away from one anolher during use WO 96120749 PCT/~JS95J16396 in response ta conlact by tissue or other instruments to c;l,a"ge the size of operali,1g spacc~ 827 for adjustability.
Fig. 17 ill~lrales at 910 the distal portion of a Illudiricaliu~ of an ei~dndable mul~ifu"ctiGnal instrument wherein the e)~ nda61e m~")ber 916 has a closed annul~r ring toroid or doughnut-shaped configuration. Expandable ",em6er 916 includes an outer wall 935 and an inner wall 937 secured to tubular body portions '~56a and 956b of spine 940 to form a closed or sealed annular envelope or baç~. Inner wall 937 has a p~ss~e defining portion 938 aligned with the lumen of inner rllelllber 912 to define an operating or working channel communicating with O~l dlil "~ space 927. The outer and inner walls 935 and 937 are continuous at the distal end of ex~a~,dable ",ei"ber 916 to form a closed circular or oval shape. Spine 940, which is similar to spine 840, includes body polliul ~s 956a and 956b 1 ~;,posed in inner member 912 and co"necled with semi-circular or curved arms 944a and 944b exle"ding into expandable member 916.
Arms 944a and 944b are hollow or tubular to communicate with the lumens of body pol lions 9!-~6a and 956b, respe~ rely and holes 964 in arms 944a and 944b allow fluid to be supplied to the interior of e)~pandal)le ",e",ber 916 via supplemental i1let ports communicating with body portions 956a and 956b.
Various instruments and/or fluids can be introd~ ~ced at the G~erdli"g space 927 through the luml~n of inner r"ember 912 and the p~ssage defining ~.o, liol, 938 of e~.andable r"ei~lber 916. Arms 944a and 944b normally assume an outwardly curving configuration to move or shape the ex~.a"datle ",ember 916 to the e~a"cled positio" when the outer " ,e"lber 914 is moved to the rel, dcted position as shown.

= W O 96/20749 PC~rrUS95/16396 .~ .

Figs. 18 and 19 illustrate use of instrument 910 to create an operdling space at an obstructed site within an a.)alo"~ical wall such as wall W of the inguinal region which is obstructed due to the lack of space betv~ccn ~- 5 ~c~n~
layers of tissue forming wall W. As shown in Fig. 18, a pe~ l-dli"g instrument including a portal or trocar sleeve S and a pe"el~dling mer ~ber P such as a trocar disposed within the portal sleeve S is inse~, led into wall W. Pe, lelraling member P has an e)~te" ,ally ll " ~aded distal tip 939 which can be sharp or blunt for controlled penetration into the anatomical wall W via rotation of the pe-)~l.dling ~nen,ber P. The penel,aling member P is inserted into the wall W to position a distal end of the portal sleeve S at an obstructed site in accordance with procedural use and the threaded tip of the pe"elrali~ ~9 member allows the .
portal sleeve to be placed at the exact location or layer desired with red~ced force. Fig. 18 illu:,lr~les the distal end of sleeve S positioned between the transverse al~dor"inal muscle M and the layer of preperilo,-eal fat F . Once the distal end of portal sleeve S has been properly positioned the penel,aling member P is withdrawn from the portal sleeve S leaving the portal sleeve S in place. E~dndable multifu,.clional instrument 910 is then introduced through the portal sleeve S with the outer member 914 in the exlended position such that the ~anddble member 916 is maintained in the non-expanded position. Once the ,. ;
instrument 910 is ~. ope. Iy posiliu. ,ed at the obstructed site the outer member 914 is moved to the r~t, acted position to ex~ose the ex~Ja. ,dable me" Iber 916. Arms 944a and 944b of spine 940 autû,,,dlically spring outwardly to move the e~dn d_L 'e r. ,e, . ,ber 916 to the e;c~a. ,~ed position causing se~Jaralion of a ~; ~ce, ll layers of wall W to create an initial space S' between the layer of muscle M and ;. 34 W 096/20749 PCT~US9S/16396 layer of fat F as illustrated in Fig. 19. Fluid can be supplied to ex~,al,daL.le member 916 to maintain or fill out the shape of the ex~ ~l,da~1e ",e"~L,er or to move the expardable ",el,ll)er to a further expanded position to create a secGr,d larger space; rlOWeVer the second larger space can also be created in the various ways ~reviously des~ibed herein. A vislJ~I; ;.ly device such as endoscope E a~n be introdl Iced through the lumen of inner ~I~e"lber 912 and the p~ss~ge defining ,~GILicin of expandable member 916 to visually co,lfi"" proper space creation The thusly created operdLil,g space can be u till~ed to conduct various operal ive proce d.lres and various operative procedures can be conducted within the operating space 927 of expandable ~llember 916 under direct visu~ ti~n by encloscope E. Various other instruments and/or fluids can be introd~ced t~rough thé inner member 912 and the passage defining portion 938 of the exp .ndable member 916 or through the endoscope E. Accol dinyly with the present invention layers between the skin and perilol,eum can be separated or d;ssecle.~ to create an operating space for pel~n"ir,g operative procedures wit~ out entry into the peritoneum.
Various -ddilional "lodiricatiol ,s of expandable multifunctiGI ,ai instruments having exuandable members defining an operaling or working space are illusl,alecl in Fi!~s. 20 - 22 wherein only distal polliolls of the instruments are shown. The expandable member 1016 for the instrument 1010 shown in Fig. 20 has a triangulal configuration in.side view circL~",sclibing a central triangular operalil ,9 space 1027. The ex,uar,dable member 1016 is provided with a spine 1040 including ~:wo outer arms 1044 extending along the outer lateral sides of ex~ar,dable member 1016 and two inner arms 1044' exte"dil,g along the sides W 096/20749 PCTrUS95/16396 , .......... .

of operating space 1027. Arms 1044' and 1044" are similar to arms 44 except that inner arms 1044' have inler",ediate shaped sey",e,-ls 1047 cGnro,."i"g in shape to the lateral sides of triangular ope, alil ~y space 1027. Inner r~ ~e" ,ber 1012 and outer ."ernber 1014 for instrument 1010 have flexible distal end portions and control wires 1048U and 1048D for char,y"1g the angular orienlalio" of or for angularly articulating the ex~,andable member 1016 via selective controlled bendi"g and strai~hle"i.,g of the inner and outer me"lber~.
The instrument 1110 illustrated in Fig. 21 is similar to instrument 1010 except that the exuandable member 1116 defines a round operating space 1127.
Spine 1140 for instrument 1110 is similar to spine 1040 except that the inner arms 1144' have curved i~ llel",ediate segments 1147 conru""ing in shape to the lateral sides of operating space 1127. Inner member 1112 for instrument 1110 has a distal end portion 1143 formed of coiled wire having a predeten~,i"ed bend. The distal end portion 1143 is held in a straight or s~ ~hst~rltially straight co, Idilion by . .
the outer member 1114 in an ex~ended position and automatically returns to the predeten,~ined bent configuration when the outer member 1114 is moved proximally of the distal end portion 1143 in a retracted position as shown such that the angular direction of expandable member 1116 is adjusted automatically in response to relractiol, of the outer member 1114.
The instrument 1210 shown in Fig. 22 incl~ ~des ex~a. ,dable member 1216 that is similar to expandable mel"ber 916 except that ex~u~,ldable member 1216 has a cyli"~l, ical configuration of i"creased depth or thickness. Spine 1240 for expandable ,ne")l;,er 1216 is similar to spine 940 except that spine 1240 has a plurality of arms 1244a and 1244b aligned with one another along the depth or -... .

W O9~120749 PCTAUSgSJ16396 thicl~l,ess of expandable member 1216 and exlt:"di"g per,uen~3icularly from br~, lcl ,es 125~.
A modific;ation of an e~andable multifunctional instrument having multiple e,t,~,andabl~ members c~, l ie~3 by relatively movable inner and outer members is illustrated at 1 310 in Fig. 23. Instrument 1310 incl~les outer r"ember 1314 carrying expandable ~le~ber 1316a inner .nember 1312 disposed within outer m~n~ber 1314 and carrying ex,u~nl~ tle .ner.,ber 1316b and a penet~dting ...er.lber P ~ osecl within inner lll~lllber 1312. Inner m~,llber 1312 ter-l,inales distally at a distal end 132~ and proxi~.lally at a proximal end mounted to hub 1318. Outer ~,er,lL,er 1314 terminabs distally at a distal end 1334 and p,u,ci,,.ally at a ~ roxil,lal end mounted to hub 1318. The outer member 1314 carries a ll"eaded flange in cooperative engage"~enl with a threaded internal cylindrical wall of knob 1336 allowing the outer member 1314 to be moved longitudinally relative to inner member 1312 as described previously for outer member 114. Penetrating ",e"lber P can have various configurations accordiny to procedural use includingvarious solid h~llow and needle configurations. Penetrating member P has an exter"ally threaded distal tip 1339 for penetraling ana~o",ical tissue and a ~.ruxi,,,al end mounted to an end portion 1357 of hub 1318. The tip of penel, aling ~-,e"lberPcanbesharporbluntand inthecaseof instrument 1310 thetip 1339 is somewhat blunt for particularly adva"lageous use in pleural and pe, icardial ~rucedures. Hub 1318 includes a body portion 135~ mounting the proximal ends of inner ",e..~ber 1312 and outer member 1314 and end portion 1357 mounting the pr~Ai-nal end of penet,aling me..,ber P with the end po, lion being removably secured to the body portion such as with the use of any suitable releasable detent W 096/20749 PCTrUS95116396 allowing the pene~ dLill91l1ell Iber P to be withdrawn from the inner member 1312.
Body portion 1359 incl~des a valve assembly which can be conventional for - closing off or sealing the longitudinal p~ss~ge through body portion 1359 when the penel,dli"g member P is withdrawn from the inner ~"e"~L,er 1312. The expandable members 1316a and 1316b are carried ~5 ~enl the distal ends of outer ",e",ber 1314 and inner member 1312 respecti~/ely and are fon~ed as - outerwall po,lions of the outer ~e~lber 1314 and the inner member 1312 which are of double-wall construction. Fig. 24 illustrates the construction of inner member 1312 which is also illustrative of the construction of outer member 1314.
As shown in Fig.24 the inner .~,ember 1312 is of hollow double-wall construction having an outer wall 1361 and an inner wall 1363 joined by a transverse distal wall 1365 at inner " ,er, lber distal end 1320. The inner wall 1363 defines a lumen or passage 1367 through the inner member 1312 serving as an operating or working d ,dn"el for the p~ssAge of fluid and/or instruments. Expandable member 1316b includes a layer of stretchable elastic material fon~ing a circu",rerel)lial portion of outer wall 1361. A tube 1362 defining a fluid p~ss~ge is disposed between outer wall 1361 and inner wall 1363 to couple expandable ",el"ber 1316b with a supplel"enlal inlet port 1380b disposed in hub body portion 1359 The construction of outer member 1314 is similar to that desc,il,ed for inner ~ member 1312 with the fluid p~ss~ge for the outer member coupling expandable " ,e" ll~er 1316a with a s~ ~Pr le ,~enlal inlet port 1380a ~isposed in hub body portion 1359. An ~dditional supplemental inlet port 1380c is disposed in hub body portion 1359 for supplying fluid through the lumen of inner member 1312.

.

WO 96120749 PCT/US95~6396 It should be appreci~ed that the inner member 1312 and outer Illember 1314 can be designed or constructed in many various ways to couple the eApandable rne",bers 1316 with the supple",e,llal inlet ports and that the supple~enlal inlet ports can be ~;spose~ at various lo~a~iGns on the instrument 1310 in addition to the hub body po,lio" as shown. For exa",ple the space between the o~lter wall 1361 and the inner wall 1363 can be used as the fluid passage witho~t a separ;3le tube the inner and outer ~e~lbera can be of solid wall construction with the tube or p~ssa~e disposed in or formed by a channel drilled into the thickness of the solid wall or within a recess formed in the solid wall. The fluic p~-ssages 1362 and the supple",enlal inlet ports 1380 can be desiy"ed in marly various ways and can include various structure for establishing fluid communic~tion with the ex,~,andable members.
The inner member 1312 and the outer member 1314 are mounted to hub 1318 to normally ~Josilio" the outer member 1314 in an exle"ded position wherein ex~ardable member 1316a is disposed pruxi",ally of ex,l.a"dable ",e"lber 1316b ~s shown in Fig.23. In the extended position the outer member flange will be disposed at a distal end of the p~ss~ge of knob 1336 to maintain the outer memb~r 1314 in the eAte"ded position during penel,aliGn of analorr,ical tissue and the hub body portion 1359 has an internal configuration to permit proxi",al movement of outer member 1314 from the eAIe"ded position to a acled positon as shown in Fig. 25 to i"crease the separ~lion dislance between eA~,anliable ",e,nbers 1316a and 1316b. With the end portion 1357 of hub 1318 coupled with the body portion 1359, the penelrali"g member P is disposed withirl the inner member 1312 such that the penelraling ",e"~ber tip -; CA 02209248 1997-09-16 ~;~ W O 96/20749 PC~rAUS95/16396 - 1339 protrudes distally beyond the distal end 1320 of inner ",e"lber 1312 and the inner and outer ",e",ber~i form a portal sleeve for penel~ling ",en,ber P
- Figs. 26 - 29 illustrate use of instrument 1310 in extraperilo"eal inguinal hemia repair. As shown in Fig.26 the ~"el,aling " ,ember P is inse, led beneath the skin and sl ~hu It~rleous fat F' fo~ y wall W in the inguinal region. Prior to - or sl Ihse~l ~ent to inse, lio" of instrument 1310 into wall W the outer r"el,lber 1314 can be moved to the retracted position to increase the dislance between ~andable ",e"lbe(~ 1316a and 1316b in accordance with procedural use. Fig.
26 illustrates outer me",ber 1314 moved to the retracted position subsequent to l(aliol, of wall W by pe"~l, aling me.,lber P to position instrument 1310 along side a he",ialed bowel B with e~"dable "~e",ber~ 1316a and 1316b at ~posile ends of herniated bowel B. Once the expandable members 1316a and 1316b -- have been properly positioned, fluid is supplied via supple~"enlal inlet ports 1380a and 1380b to move the expandable members 1316a and 1316b, respectively to the ex~al)ded position and the pe"et, dling member P is withdrawn. By controlling the amount of fluid supplied to the ex~dndable - members the ex,uandable m~ bers 1316a and 1316b can be expanded to different sizes as shown in Fig. 27. Movement of expandable members 1316a and 1316b to the ex~ dnded ,t~osilion ~ses an initial space S' to be created :- l~tv~2~n the layers forming wall W and the space between ex~andatl- me"lbers 1316a and 1316b defines space S'.
As shown in Fig. 28, addilio~al fluid can be supplied to elcl.andable members 1316a and 1316b to inc,ease the size of the expandable members to create a second larger space S2. Allernali~/ely in conjunction with or in addition to further expan ;ion of e~andable ,nembers 1 316a and 1 316b the second space S2 can be creal.ed in the various ways previously described herein. In multiple puncture ,c,~,cedures an additional penel, dlil ~y instrument including a penet, ali, Ig Ill~lllber P' and a portal sleeve S' is introduced into wall W to posilion the portal sleeve S' in commu"~ n with the thusly ~atecl Gperali"y space S2. Once the portal sleeve S~ is properly ~.osilio"ed, the penel~ling ~l~elll~er P' is withdrawn therer,un, allowing various additional instruments 1, such as a foroeps, to be introdl ~cecl at the operdli"g space for use in repair ir ~9 the hernia as shown in Fig.
29. Once the fir1al operating space has been created the hernia is repaired via instruments intro~ ced through instrument 1310 or through additional portals and the hernia can be repaired by securing a mesh to the bowel.
Fig. 30 illustrates at 1410 a distal portion of a modification of an expandable m~ltifunctional instrument accordi"g to the present invention.
Instrument 141 ~ is similar to instrument 1310 except that expandable members 1416a and 141é3b are made from a non-elastic non-sl,etchable material such as plastic.
Another m Cidi~ 3tiGn of an ex~,a"dable multifu"~ tio,)al instrument a~ording to the presenl invention is illusllalecl at 1510 in Fig. 31 wherein only a distal portion of the instrument 1510 is shown. Instrument 1510 is similar to instrument 1310 except that instrument 1510 includes a single outem~ember 1514 receiving penetrating member P. Outer member 1514 is similar to outer member 1314 except that ouler ",e"ll)er 1514 inclucles one or more adjustable collars 1569 ~I;sposed over ex,uandable m~ ber 1516 to form a plurality of e,~andable ",e"~berportion~. Instrument 1510 has two collars 1569a and 1569b of dir~erenl O 96/20749 PCTrUS95/16396 sizes disposed over eA~,a,1da~le member 1516 to form expandable r"e"~ber po, lions 1516a 1516b and 1516c with expandable member portions 1516a and 1516b being separaled from one another by a distance that is ~~realer than the d;slance that eA,~Idnddble me,nber portions 1516b and 1516c are sepdl dted from one another. Various structure and a"a,)gement of eA~andable multifunctional instruments having adj~ ~st~hle collars are shown in the prior applications.
AnothemlloJirlcdlion of an eA~,andable multifu"~tio"al instrument accGrding to the present invention is illustrated at 1610 in Fig. 32 wherein only a distal portion of the instrument 1610 is shown. Instrument 1610 includes outer member 1614 and inner member 1612 carrying exyd"dable ~"e",ber 1616 which is made of an absorbent material such as sponge or gauze. EA~rdl)dable member 1616 has a first configuration in a non-expanded position wherein the expandable ",e,nl,er is in a dry state to be dicposed within outer member 1614 and a second configuration in an ex~dnded posilion wherein the ex~andable member is in a wet state. E~andable ,ner,lber 1616 in the non-expanded position is in the nature of a s~ onge or gauze stick and has a coiled configuration in the ex~rdnded position defining a cylindrical operating space 1627. Expandable member 1616 is particularly useful for being disposed around tissue or organ structure and for lifting or otherwise manipulating tissue or organ structure to create a space at an obstructed site. EA~Jdllddble member 1616 is moved to the eA~Jdllded ~osiliG"
upon retraction of outer member 1614 to expose the expandable member 1616 in the body. The eA~ andable member can be moved to the ex,~,anded posilion fluidically via absol~,lio" of body fluid by the absorbent ",alerial or via fluid supplied to the expa"dable member and/or ",echd"ically as previously desc, ibed .

herein. A spine -an be provided exter"ally of internally of or within the ll ldterial rO~ y the expandable member 1616 for shaping or rigidifying the ex~.andable men ,ber and/or f~r " ,a~;l ,a, .,~y moving the ex~dl ,ddble ll l~m~er to the eA~anded position. Wher~ a spine is provided the spine can be uti~ to supply fluid and/or medicina' or ll)erapeutic s~ st~- ,ces and fluid can be as~.i~led from the expandable menber through the spine to facilitate withdrawal from the body.
Various e3~andable "~eml~r:, made of absorbent ",alerial and having use in the present inventic~n are disclosed in applicant's prior applications Serial Nos.
07/600 775 filec October 23 1990 and 07/556 081 filed July 24 1990 the ;sclosl ~res of which are i. ,corporaled herein by rererence.
Figs. 33 - 35 illustrate expandable multifunctional instruments accordi"g to the prese"l invention in use in various operative p,ucec~ures. Fig. 33 illustrates instrument 910 in use in a three puncture procedure of preperitoneal endoscopic direct hemia repair. E~d"~lable member 916 is positioned along side herniated bowel B between the superficial fascia L and the exle",al oblique muscle M of wall W and is n~oved to the expanded position to create an operaling space l~tY/ccn the layers of wall W propd, ielal or e)clrap~ ietal with the bowel B being held in a cuppir;g ~a~"~er within the working space 927 of the exuandable member 916. F~'ortal slccvcs S' and S" are positioned in the wall W in communication with the thusly cr~aled operali, lg space allowing various instruments to be introduced therelh~uugh for use in repai. i"g the hernia. The instrument 910 ccln be introd~ced into wall W via a portal sleeve (not shown).
Fig. 34 illu~trates instrument 1610 in use in an ir,l,~,eriloneal e"dosco~ic direct hernia repair ~urocedure. The ex,us,,~lable me,nber 1616 is posiliûned r.~ , , - W 096/20749 PCTrUS95tl6396 a~jacent the her- ,idled bowel B between the inle, ~ ,al and exte~ ~ ,al oblique muscles .
M' and MN, respectively of wall W and the instrument 1610 can be introdu~ed through a portal sleeve (not shown). The expandable member 1616 is moved to the ex~uanded position M to create an operating space s2 i- ,ler~,a, ietal with the coiled configuration of the e~a. ~dable l l lel nl-er separaling ~- ~j ce, ll layers of wall W to ueate space s2 and provide an oper~li. ,g opening for receiving bowel B in a cupping ma~" ,er and/or providing an area for pe, rGl,l~;l l9 operali~/e p.ocedlJres.
Fig. 34 illustrates a two puncture technique in that an additional portal sleeve S
is inserted in wall W to allow various instruments or fluid to be introduced at the operating space.
Fig. 35 illustrates expandable multifunctional instrument 1210 in use in e~ aperiloneal endoscopic direct hernia repair. Expandable member 1216 is ~osilioned between the transversa fascia L' and the peritoneum L2 and is moved to the expanded position to create an operating space s2 rel,op~iietal or iut, ~pd(ietal between layers L' and L2. Various addilional instruments or fluid can be introduced through the working channel of instrument 1210 to repair the herniated bowel B via the operating space 1227.
Another mo~Jiricalion of an expdndable multifu"ctio"al instrument accordi,lg to the p,esenl invention is illusl~aled in Fig. 36 at 1710, only the distal portion of instrument 1710 being shown. Expandable multifun~tio"al instrument 1710 is similar to ex~.anda~le multifunctional instrument 1310 except that penel,alin~
",e"~Ler P which carries e~andable ,nember 1716a is cannulated or hollowwith an angled distal tip 1739. A remote visu~ tion device such as an endoscGpe E is .I;~posed within the ~nel,ati"g ll,er~lL,er P with an image receiving distal end W 096l20749 PCT~US95/16396 of the endosco ~e posili~ned relative to distal tip 1739 to provide visu~li7~tion at the distal end of instrument 1710. Use of instrument 1710 is similar to that previously described except that e,ldoscope E is introd~ced in the body along with pe"el,dli"g ",em~er P to visually identify and locate the polenlial space or proper site for c~edliol . of the actual initial space. In this manner the surgeon will know when the potenlial space has been reached at the obstructed site and ll,eredrlerthe e~a"dable n,e",ber 1716a and/or the ex~.a"dable me~ber 1716b carried by outer member 1714 is moved to the e~.l,c,,ded position to create an actual space at the obstructed site. Depending on the configuration of penel,ali"~ m~mber P the visualiza~ion device can fill the lumen of the pen~lle~lillg member or be disposed in a channel or passage of the penet~aling me",ber or along side the penet~ali"g member aligned with or non-aligned with a longitudinal axis of the ,uenellatill9 member.
Fig. 37 illustrates at 1810 a further modification of an expandable multifunctional instrument according to the present invention. Instrument 1810 is similar to imltrument 1310 and includes an outer member 1814 terminating distally at a distal end 1834 and plw(illlally at an enlargad U"eaded coupling 1871 having an open rearward end. A valve asserl!blyi such as a nipp!e va!ve 1873, is mounted in the coupling 1871 to prevent undesired fluid flow through outer member 1814. An inte"~ally II"eaded annular cap 1874 is mounted on the rearward end of coupling 1871 in e"~aye,..e,.t with the thread thereon. An elo,)gate tubular middle n,e",ber 1875 is disposed in outer n,ember 1814 and terminates distally at a distal end 1877 and pro~i",ally at a flange 1878. A
co,..p~ssics,~ spring 1879 is mounted in coupling 1871 in engagel"eul with flange 096/20749 PCTnUS95116396 1878 to bias the middle member 1875 distally. Expandable "~e"~ber 1816a is carried by outer n,ember 1814 which is of hollow double-wall construction d~rlnil lg a p~ss~ge between outer and inner walls thereof coupling e~d"dakle member 1816a with inlet port 1880a disposed along coupling 1871. Middle m~r,ll,er 1875 carries ex~andable ,ne,nber 1816b and is si",ilarly constructed of hollow double-wall construction to define an inLerior p~ss~ge coupling expandable ",e",ber 1816b with inlet port 1880b rlisposed on flange 1878. A
penetrating member P is disposed in middle member 1875 through an opening 1881 in cap 1874 and terminates distally at a faceted tip 1839 for penetrating analo",ical tissue. With the components of instrument 1810 assembled the tip 1839 of the pen~, dling ,ne" Iber will protrude distally beyond the distal end 1834 of the outer member 1814 and the middle member 1875 will be biased to protrude distally beyond the distal end 1834 of the outer ",e",ber 1814 such that expandable member 1816b will be disposed distally of expandable member 1816a. During penet,alion of al,atolllical tissue middle ",er"l,er 1875 will be moved pro,(i",ally against the bias of spring 1879 and upon a reduction in force from tissue contact at a distal end of instrument 1810 the middle member 1875 will move distally to position ex~Jdndable member 1816b distally of ex~andable member 1816a. It should be app,~c;~led that automatic distal movement of middle ~"err,~er 1875 can be obtained where the nature of the tissue at the obstructed site is such as to reduce the force from tissue contact at a distal end of the instrument 1810 to allow aulo,na~ic protrusion of the middle member 1875 however various structure can be provided in the instrument 1810 to allow extension of the middle member 1875 manually selectively when the potential W 096120749 PCT~US951163g6 space is reached. Once the instrument 1810 is properly posilicj"ed at the polenlial space with ex~Ja"da~le member 181 6b disposed distally of expandable member 1816a, the ex,~,a"dable ."e~,bers are utilized to create an actual initial space and operating space as described previously above.
The expandable multifunctional instruments according to the pr~:se~l invention c;an include any number of inner, middle and/or outer ,ne"lber:, c or,cenl~ically or non-conce"l,ically ~lis~Josed and any number of expandable ",e,nLe,~. The l~pandabl~ members can be carried on any of the inner members middle members and/or outer members and can be made of slretchable elastic material, non-stretchable or non-elastic material, absorbent material or any combination thereof. Where absorbent materials are utilized the e~"dable members can te utilized to absorb bodily fluids such as blood, for enha,lced visl ~ lion anc~or pe, ru, Illdl ,ce of oper~ti~e pr~cedures. Where the ex~andable members are ca~ried by the outer ",e",bers the outer members can define portal sle~vcs for receiving ~enel~ dl.il Iy members for penetrating tissue to introduce the expandable members at obstructed sites.
The expa~dable members can be provided with or without various spines for maintaining the shape of the expandable Illember~ in the expanded position for providing rigidity to the exl.andable members and/or for moving the expandable members to the expanded posilion. The spines c an be disposed exle, I ,ally of, inle" ,ally of or within the material of the ex,..andable members. The ~ spines can extend entirely through the instruments or partially through the instruments ancJ the spines can be hollow or tubular to allow fluid flow through the spines.

.-~W 096/20749 PCTrUS9S/16396 The expandable ,ne",bers can be moved to the ex,uanded position fluidically via inflation or via absorption of body fluids or fluids supplied to the . .
ex~andable me"lbe~s r"ecl~anically or any co",binalion thereof. Where the e;~"~able me~ are moved to the e~anded position fluidically fluid can be 'supplied through the inner r"er"bers, middle members spines control tubes between the inner r~er~lber~ and the control tubes between the inner ",e",be,:j - and the spines through the outer rnembers and/or through sq~a,ale fluid p~ss~ges coupling the expandable members with the inlet ports.
. .
The ex~a"dable ",ember~ can be continuously expandable to ~irrere"t sizes or can have various predeter",i"ed sizes in the expanded position. The expandable members can have various predeter" ,ined or prefor, ned configurations or shapes in the expanded position in accordance with procedural use including various shapes for holding or manipulating tissue and defining or circumscribing various working or opel clir ,g spaces. Some configurations for the e~a"d~ble " ,e, nbel ~ that are particularly adva"lageo~ ~s include triangular toroid, round multiplefinger J-shaped annularordonut-shaped C-shaped U-shaped spoon-shaped oval, single or multiple ball-shaped and coiled configurations.
With the use of certain shapes such as multiple finger shapes the e,c,~,andable n,e"lber~ can be used to retract or expose a"d~o",ical tissue. The e,.,uandable me~nber~ can be invertible to continuously roll or invert when instruments are r~ssed ll ,er~t~ " ough as ~:sclosecl in prior arplit~tion Serial No. 08/220 359 filed March 31 1994 the disclosure of which is incorporated herein by rererence.
The ex~ar,dable member:j can be ~I;sposed within the outer members to be unexposed during introduction in the body and/or to be ",ai"tained in a non-W 096/20749 PCTAUS951163g6 e;c,udnded posilion. The outer ",e",ber-~; are movable from an exle,)cled pOSiliG"
to a rel, acled p osition to expose the expandable me,nbers, to permit movement of the expand~ble "~embel:, to the expanded position and/or to increase the space or distance between multiple ex~a"d~L,le members. The ex~,~"dabl~
mel,lber~ can be moved to the eA~dll-Jed position aulo",dlically in response to retraction of the outer ,ne,nbers. Where multiple expandable ,)~e,),be,:j are provided, the cistance or separ~lion between the ex~andable n~el,)bers can be selectively adjusted with the use of relatively movable inner and outer members or with the use of adjustable collars. The angular orientation of the expandable members can be adjusted, and the e~ andable me",ber~ can be artiu~l~ted angularly via various spring mecl ,a"isr"s, wire adjusl" ,ent systems, ,u~ ele~ ined bent ",e",ber-~; and two-coiled tubing. The e)c,~,dl,dable me",be,:, can be aligned with the longitudinal axes of the instruments of offset thererro",.
The working or operali-lg p~ss~ges of the expandable mel"bt:r~ can be aligned with the longih~dinal axes of the expandable members of offset therer,un,. The expandable multifu,)ctional instruments can be designed in many various ways to permit drainage through the instruments.
According to the pr~senl invention, initial sp~ces are creale-i at obstructed sites by introducing or injecting fluid under pressure at the obstructed site or by ex~,anding exp~ndable ."embers at the obstructed sites. In particular, fluid can be intro~uced at obstructed sites in areas such as the breast, lung, brain, structure adjacent embolic or anuretic a, leries or veins, relroperiloneal sp~ces, layers of the sp nal cord, ~ pe, iloneal sp~c~s for ventral hemia or inguinal hemia repair, s~ Ihcl ~t~neous tissue for removal of ganglia, benign lumps or melanoma, W 096/20749 PCTrUS95/16396 .

bowel or bowel wall, liver, spleen, pan~as, kidney, gall bladder, uterine wall, the space of Retzius utilizing liquids, and pathological locations and locations adjacent patholog;cal localions. Upon c,edlio,) of the initial s~.~ces seco,ld spaces can be cr~dled by ex~a".Jir,g e.~Ja"dable members at the initial .sp~ces, by moving ex~ua"ded ex,.,zndable members at the initial sp~ces and/or by introducing fluid at the initial spaces The initial spaces can be of a size just large enough to permit visual observation such that the second sp~ces, which can be large enough in size to provide sufficient room for pe, ro",~ing operdlive procedures, can be credled subsequent to visual coilrir,l,~lion of the proper location of the initial sp~ses. Accordingly, if the initial sp~ces are not at the proper location, connective measures can be taken without excessively large sp~ces having been formed. The thusly created operating sp~ces can be maintained by leaving the expandable multifunctional instruments in place or by withdrawing the eA~Ja"dal,l_ multifunctional instruments and introducing fluid at the operating spAces. Where left in place, the e~ a"dable members prevent withdrawal of the instruments from the body allowing the instruments to be used as portal sleevcs without the risk of backing out from the body.

, .
Accordi"g to the present invention, creation of the initial and second spaces as well as procedLIres condu~ted prior and sl ~hse~uent tl,ereto can be visu~li7ed using rerllote visualization devices. Fluid introduced for insufflation, - - to create spaces or for 11 eat" ,enl procedures can be supplied via the ex~,ar,dable - multifunctional instruments, via the remote viewing devices, or via sepalale instruments and/or portals. The eA~Ja,)dal~le multifunctional instruments can be - introduced in the body via various single or multiple portals, via the remote viewing devices or via instruments used to supply fluid. Various penel,dli"g members can be used in the expandable multifunctional instruments for simultaneous pe"el,d~ion and positionin~ of the instruments in the body. By using remote viewing devices along with the ,ue"el, ~ling members, the obstructed sites can be located visually for co"ri""ialion of pe"el,dlion of the instruments to the desired depth or layer. Various additional instruments can be introrluced in the body via the expandable multifu"c~ional instruments or via separate portals, such additional instruments including ~issecting instruments, scissor:., combination biopsy and scissors instruments, forceps, suturing instruments, needle and suture needle holders, suction instruments, cutting instruments, combination suction and cutting instruments, clip applicators, ring applicators, coagulating instruments, cautery instruments and spo"ge sticks as well as other multifunctional ei4 a, .dc ': le instruments. Various procedures can be performed accordi"g to the present invention utilizing single or multiple puncture techniques. The present invention is par~icularly useful in hernia repair including repair of direct, i"direcl, encysted, funicular, vaginal and infantile hernias without entry into the abclomell.
In addition to Ihe areas previously described herein, other areas where the ,u,~senl inventicn is useful include liposuction, ileostomy, jeju.,oslo",y, colostomy and anaslon-ic procedures.
Inasmuch as the presenl invention is subject to many variations, m~Ji~icalions ar d cl~anges in detail, it is i. ,lendecl that all subject matter ~~iscusse~l ~ above or shown in the acco."panying drawings be inle- ~reled as illustrative only and not be taken in a limiting sense.

Claims

What is Claimed is:

1. A method of creating a space endoscopically at an obstructed site in anatomical tissue including the steps introducing an expandable multifunctional instrument in the anatomical tissue to position an expandable member of the expandable multifunctional instrument at the obstructed site;
moving the expandable member from a non-expanded position to an expanded position to displace the anatomical tissue to create a space at the obstructed site; and visualizing the thusly created space endoscopically.

2. The method as recited in claim 1 wherein said step of introducing includes introducing a penetrating member at the obstructed site along with the expandable member.

3. The method as recited in claim 2 wherein said step of introducing includes rotating the penetrating member into the anatomical tissue to reach the obstructed site.

4. The method as recited in claim 2 wherein said step of introducing includes introducing a remote visualization device at the obstructed site along with the penetrating member.

5. The method as recited in claim 4 wherein said step of introducing includes introducing an endoscope through the penetrating member.

6. The method as recited in claim 1 wherein said step of introducing includes introducing a plurality of expandable members.

7. The method as recited in claim 1 wherein said step of moving includes moving the expandable member to the expanded position fluidically.

8. The method as recited in claim 1 wherein said step of moving includes moving the expandable member to the expanded position mechanically.

9. The method as recited in claim 1 and further including, prior to said step of moving, the step of visualizing the obstructed site endoscopically.

10. The method as recited in claim 1 and further including the step of increasing the size of the space.

11. The method as recited in claim 10 wherein said step of increasing includes supplying fluid under pressure to the space.

12. The method as recited in claim 10 wherein said step of increasing includes manipulating the expandable member in the expanded position to further displace the anatomical tissue.

13. The method as recited in claim 10 wherein said step of increasing includes introducing an additional expandable multifunctional instrument, to position an expandable member of the additional expandable multifunctional instrument at the space and moving the expandable member of the additional expandable multifunctional instrument from a non-expandable to an expanded position.

14. The method as recited in claim 1 and further including subsequent to said step of moving the step of maintaining the space.

15. The method as recited in claim 14 wherein said step of maintaining includes leaving the expandable multifunctional instrument in place.

16. The method as recited in claim 14 wherein said step of maintaining includes withdrawing the expandable multifunctional instrument and supplying fluid under pressure to the space.

17. The method as recited in claim 1 and further including performing an operative procedure utilizing the space.

18. The method as recited in claim 17 wherein said step of performing includes performing an operative procedure within a working opening of the expandable member.

19. A method of creating an operating space endoscopically at an obstructed site in anatomical tissue including the steps of introducing fluid under pressure at the obstructed site to displace the anatomical tissue to create an initial space at the obstructed site;
visualizing the initial space endoscopically;
creating a second larger space at the obstructed site from the initial space;
and performing an operative procedure utilizing the second space.

20. The method as recited in claim 19 wherein said step of introducing fluid includes introducing an immiscible fluid.

21. The method as recited in claim 20 wherein said step of introducing includes introducing a gel.

22. The method as recited in claim 20 wherein said step of introducing includes introducing a viscoelastic material.

23. The method as recited in claim 20 wherein said step of introducing includes introducing a liquid.

24. The method as recited in claim 19 wherein said step of creating includes introducing an expandable multifunctional instrument at the initial space and moving an expandable member of the expandable multifunctional instrument from a non-expanded position to an expanded position to displace the anatomical tissue to create the second space.

25. An expandable multifunctional instrument for creating a space endoscopically at an obstructed site in anatomical tissue in the body comprising an elongate member having a distal end for being positioned at the obstructed site and a proximal end for being held externally of the body; and an expandable member carried at said distal end of said elongate member, said expandable member being movable from a non-expanded position to an expanded position to separate the anatomical tissue to create a space at the obstructed site.

26. The expandable multifunctional instrument as recited in claim 25 wherein said expandable member includes a balloon movable fluidically from said non-expanded position to said expanded position.

27. The expandable multifunctional instrument as recited in claim 25 wherein said expandable member includes a balloon movable mechanically from said non-expanded position to said expanded position.

28. The expandable multifunctional instrument as recited in claim 25 wherein said expandable member includes an absorbent material movable fluidically from said non-expanded position to said expanded position.

29. The expandable multifunctional instrument as recited in claim 25 wherein said expandable member includes an absorbent material movable mechanically from said non-expanded position to said expanded position.

30. The expandable multifunctional instrument as recited in claim 25 and further including an outer tubular member receiving said elongate member, at least one of said outer tubular member and said elongate member being movable relative to the other of said outer tubular member and said elongate member to position said outer tubular member in an extended position wherein said expandable member is disposed within said outer tubular member and to permit movement of said outer tubular member to a retracted position wherein said expandable member is exposed from said outer tubular member.

31. The expandable multifunctional instrument as recited in claim 30 wherein said expandable member is constrained by said outer member in said extended position to be maintained in said non-expanded position.

32. The expandable multifunctional instrument as recited in claim 31 wherein said expandable member is movable automatically to said expanded position in response to movement of said outer member to said retracted position.

33. The expandable multifunctional instrument as recited in claim 32 wherein said expandable member includes a spine for biasing said expandable member to said expanded position.

34. The expandable multifunctional instrument as recited in claim 25 and further including an outer tubular member receiving said elongate member and a second expandable member carried by said outer tubular member at least one of said outer tubular member and said elongate member being movable relative to the other of said outer tubular member and said elongate member to position said outer tubular member in an extended position wherein said expandable member is separated from said second expandable member by a separation distance and to permit movement of said outer tubular member to a retracted position wherein said expandable member is separated from said second expandable member by a second greater separation distance.

35. The expandable multifunctional instrument as recited in claim 25 wherein said elongate member is a penetrating member.

36. The expandable multifunctional instrument as recited in claim 25 wherein said expandable member in said expanded position defines a working opening within said expandable member for performing operative procedures.

37. The expandable multifunctional instrument as recited in claim 36 and further including a passage in said elongate member communicating with said working opening.

38. The expandable multifunctional instrument as recited in claim 35 wherein said penetrating member has a channel therethrough and further including an endoscope disposed in said channel.

39. The expandable multifunctional instrument as recited in claim 25 wherein said expandable member has a multiple finger configuration in said expanded position.