CA2109714A1 - Retraction apparatus and methods for endoscopic surgery - Google Patents

Abstract

A first inflatable retraction device has a first inflatable chamber (5) and a non-pressurized chamber (13) inside the main chamber. The non-pressurized chamber is expanded by inflating a second inflatable chamber (25). The non-pressurized chamber enables the main chamber to remain inflated when an aperture is cut in the envelope of the main chamber, through which treatment is carried out. A second inflatable retraction device has an inflatable retractor (103) and a maintainer (107). The inflatable retractor retracts the organ and the maintainer maintains the organ in its retracted condition after the inflatable retractor is deflated. The maintainer can be inflatable, and can be inside or outside the inflatable retractor. A self-retracting endoscope (201) has an optical assembly with an expandable retractor (211) fitted to its distal end. The distal end of the endoscope is inserted into the body with the retractor in a collapsed condition. The retractor is then expanded to retract organs that would otherwise obstruct the view from the distal end of the optical assembly. After observations are complete, the retractor is returned to its collapsed condition. An insertion tube (243) enables cylindrical objects, such as packaged inflatable retraction devices, to be pulled, instead of pushed, into the body. The additional chamber of an inflatable retraction device having two inflatable chambers is filled with a slurry of a particulate solid in a liquid. The liquid is removed and the additional chamber evacuated to consolidate the particulate solid. This increases the retracting strength of the additional chamber.

Description

;~. \/O,'~:t~l~A-~1t.E.~.C~tJ~ Jff : ~ Y;~: 1):;3;~ Ci'l r EC.U-- t~9 S~ '3Y4~tiS~

2iO9711 ~ATlO~AL APPlaCAT~C~N U~ER T~
PATi~ C~OP~TlC~

~IC~TION FOR PA.TE~T -.
~3TRACTI(:IN APPA~A~S A~ ~B~ODB ~ E;NIX)SCI:)PIC ~ l~Y

ede~c ~. M~ll, a~d . .
'~ E. Chin ..
3~eld ~ tht~ on T~e inven~ Ges t~7 deY~s ~ ~scopic suTgery, L~l pa~cuL~, devi~ pro~ ~on of aIl a~g~n to gain acc~s~ w ~ ~ obs~rc a ~e.
. ~ , Ba~g~uDtd ~ th~ e~io~ ~
5 ~s~p~ da~es ~ t~ the ~tm of the 20t~ C~h3ry. E~ly la~ t~pi~
~u~ ~e~ used p~y ~or diag~ic pu~po~e~ t~ v~7 the i~tte~nal o~
w~ the ~y of c~n~ro~al s~y. S~ ~, ~aroS~p,y has b~
used ~r ~ d, m~ ~ce~y, for su~g he~m~. U.S.~ Pa~ 4,~19)15 a~d 4,~443 ~ c~d with ~iq~ f~r 5~ he~ias. ~he~ ~

~ ublisb~i ~tB~ aion No. WC~A ~212~1, ~ a~plication o~ w~i~h ~i~ ap~ on ~s a Coc~ P~y descr;bu as~ 3 an~i methad whero~n t~
abd~niQal w~ i~ l~ed aw~ ~cla ~e und~ g abdow~l o~ b~ an i~fla~le wh~ ~ ~g ~ ~ a~ ~ the a~ or ~ue ~o be. ~d c~ ob~

20 ~CII, ~t la~xcpic p~ du~i uae ~ small ~esal or gh ~p~ af ~a ~use ~ch ~ h~ve a.~adYe~

. M~vcs, ~he re~irem~ fo~ a pl~r~lity ~f i~is~ ~o ~eal m~y d~y ~ ~?2~ent's 2S P~ hed I~erna~ ~p~ica~io~ No. W~A 92/21293 ~tbe "p~ a~lica~
o~ wl~ tl~ a~?li~on is al30 ~ conti~~ de~ib~ a ~nber o~

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.

de~ices ~ a~e ~ntroduc~d into the bo~y i~ a o~psed c~di1ion and, oncc ~n place, a~e expa~dzd by in~a~g a ~ infla~le ch~n~er~ to ~act organ~ or ~ and ~o pr~vide a~s3 to the org~ ot ~su~ being trea~d. The r~a~ ~ices de~csl~ L~
the appliG~on.~vido a r~a~ely lar~e ~ace area to t~e orga~ ~g S retra~ so t~ ~ac~ion ca~ t;~ke plæ~ w~th a ~ imal ns~ of dama~e to th~ re~act~d orga~ ~r ~issuc, Ib~e rda~vely large re~on d~ic~ inclu~ awdlia~ for maint~ning ~ sh~e ~er i~flatic~ ~ch aa an additional se~nd i~flatable ~hamber having a ca~l~e ~cnl~e, or a ~pnug :ago ~ment. The~e~au~liary means ~abb ~acdan ~ be maintai~ed a*es tbc mai~ c~b~r l~
10 by cu~g ~ in it to ~ain acces~ thwugh ~e re~ac~oQ de~ ~o ~eat tho or ~s~ue bei~g ~ea~ed.
rhe re~:ion del7~ce~ desc~ibed m :he p~ior a~plica~on provid~ a ~ignificant ~p~vc~ ~ P~t~8 a~ss to ~ o~gan or ffssuc W~g t~eated du~ing ~seopi~
r~ ~ch~v~es h~ep~oblems. Wh~ an infla~ablere~n 5 d~YiC8 ~ h ~l ~ cage s~ruct:ure prov~ g a re~xi~n affect ~i~t t~ that of the main cha~be~ is ill its c~l~ s~e, ~;s envolopo has a sign~icant ~ . The bul~- of a ~racSion dovic~ 11ap~ed s~o will b~ called the "c~lL~p~cd bu~" ~f the ~n ~e~ce A~ i~bb ~n devi~e that has a laræe collaps~
difflcul~ t~ pachge in i~ ate so ~ it eatl be inser~l i~ the body thrDugh 20 a ~ow tIocar ~be (14 mm or le~s m d3ame~Gr). Eve~ whe~ ~e pa~ge can be ~ate s~all.en~ugh, is can b~ a d~ it in ~he tracar ~ube, and pus~g ~uch ~ght-fi~ng pa~ages tb~ugh ~ ~rocar t~bo is diffi~l. rne pas~ t~nds to buc~le w~ push~d, ~t is al~o des~able to~ g endo~e to ~imp~ e~d~æopbc Ur~d S~ P~ ?~ 447,~1 ~Jf ~s, ~ow9 an number ~f mul~ 06e pate~ ;~ i~t~ed f~r use m a 1~. lf such deY~c~ were wd far Je~c~
they w~uld ~ct access ~o thc ~e. S~me of ~e dc~ inchl~e a~ in~erDal hlme~
.

~v~ng a~ss ~ f<:~r ~4 a ~ue.
~'~ St~e~ Patent No. ~774,S~6 to Co~k show~ v~ ~m ~68ng of plulal infla~le ~ ~vhich, whes~ ted, fonn a hexago~
35 I~m~diral ~ ~t tbe api~ of ~he pa~ls pro~de l~gitlldiD~ s~ffness~ and the p folded on tbo b~ o deNice is ~s~l al~d is adapted ~r ios~lioo into a body E V(?N:EP~ ,'E:~CHe.\l U6; : 6~ 9~3 ; ():;34 : ccln EC~ 9 ~S3 ';3~3S34~6~
- 210971~

a~e i~flat~d ~d u~d ~rom tbe basc ~ f~ t~e ~exag~al cylind~r. Ibe b~dy G~Vity Wi~ V8 an~ pI~ilbd m the i~lalabIe p~cls t~ pr~rido ~cc~s to the body ~.

acccss t~ ~ue ~ng ~. Howcv~, Caa3c'~ stn~ ~auld ~ot be scited to p~g re~on i~ hp~pic a~ In~g tl;~t p~c~ are ~la~vely in~i~ie~t in co~g in~ation ~ples~ i~ ~:nv~ ~orce. ~o~s~tLy, ~a pro~ide ~e ~acdnn ~rce re~i~ed to ~et~act a~l o~, a bigh in~ n pressu~ ~rould ~ve ta be uscd. ~ ~n, would ~ th~ th~ i~ats~bk p~els be cons~ed of a thicl~ ma~ ~ik of the thi~ material o~the inflalablepa~, ~a~ether w~
tbo l~ of the 1~ngi~ rads, and the buik of the base r~ake Coo~'s de~ce ill its collap~ed sta~e Do ~ f~r iDsenion throu~h a lapa~c~p~c incisio su~q a~ the ~Ol~.
e follow~s~ desaip~n, the w~ OI~a~n ui~. be llsed ta meaII aD o~m or a ~sue that ls leUaChsd by a~ ~tncticn dc~ Ihe wa~ ~n wi.~ used to mea~l Dd obs~. ~-~wo~ e~pl~se ;'tissuc to bc trea.l;cdn uill both be ~ to mca~ or the~ sue ~ is ~od ~ough o¢ inside a ~on dc~.

a ~ i~ r~aciDg tbc org~n w~ thc first infla~ble mean~ LS im1abd to a~ e~ded coadi~.~ ~:fin;t-i~Le:mealls includes a $~ c~vd~. The i~l~o ~on de~ice also;~iDcludes a~ means for ~ecti~ infl~g ~e ~
~o ~ into a~ ion~w~ placo ~n the body. Ibc int~tablo F3na~,~ ~ i~blo ~ dtvise~i~ciude~ an aCcc~ mcans f~ ding a EP.~ 3'~ C~i ~3~ ;-9;,~ .5 : CC 1'1~ EC:~I~ ~49 ~9 ~;3994~ 8 210971~

~ be dss~e ~s ~:d thr~agh the treatme~t window ~ ~ p~ ~ the f;r~ u~velope c~ve~d by ~e aon-p~ss~rized ~hambe~. ~ume~ts as~ passed from o~de the body tbrough a ~ ht p~ ~to the ~ iD~b~e c~amber. E7rom t~e fir8t iDf~

S ~ that ieakl a~uu inst~ll~3t~ a~ i~ se3f-sea~g ~h~ ~3e in~un~ent is wit~ awn, T~s mai~aills tho f~ inf~atabl~ c~amber m ~8 inR~ ~e. Alt~ ve-1~7~ al.l ~3X par~ of the second emr~pe ca~ b~ ~ade ~ a~ el~enc ma~ial ~hat pr~ acc~s~ means and ~ amu~ an inst~mc~t pa~ h it7 and is. s~
se~Lli~g ~v~on the i~um~t i~ ~wn. AS a t~d al~na~vc, :hc acc~s means can.
IO be ~ duct tl~ugh the ~t i~ata~le meaDs that ~abl~s i~en~s ~w be pa66~ from outside the i~flatable rwscti~n d~vice &ec~ly into ~ n-pres~zed chamber.
The col~apsed bu3~ of a~ iDfla~le re~ on de1fi~ ~g ~I:o thc 3~ pect of the ~ve~tion is le~ tha~ ~at of an e~uivalentl~ le n:~n dffvics o~ thc types ~e~n~ed in t~e ~ a~pl~on. ~l~ is ~ecause ~ Y~me ~he ~e~ of ths 1~ ~on-pr~s~ c~ambe~ and the seco~d imqa~e chamber is le~s th~ tb~ ltolum0 of t~e envelope ot~ ~he add;~o~al c~amber of th~ ~pes ~ ;m1atabl~ 9~ de~ic~
p~cYioll~y descr~
In a fl~t metl~od acc~rdi~ ~ tho ~e~tioll o~ using an il~flatable rcuacticn dev~ce æc~srdh2g to th~ aspoct c~ the imaltion ~o ~ ~ or~ iDs~ the b~ t~ gain 20 æces~ to a~ acent ~sue, ~h~ i~le r~m~io~ d~icc Ls pl~ l:n a c~llaps~d s~e adjace~t to ~e ~ue. Tb~ fi~t i~able ch~mbe~ is i i~ a~ axpa~ded condi~on to ~act the organ~ and the scco~ infla~ble chamber i5 iDflated to e~d t~e ~on-p I~ a ~ nd ~cd:~g to ~e in ~ ~u~ an in~table.~o~ d~Yice ~ ~o~e, ~o~ha w~th t~ inflalable re~ac~n dc~ ins~ted iDto the ~ a~dmoved ~ th~ ~e. lbe ~d i~a~71~ chambe~ of t~be ~ble 30 devi~ i~ cd t~ on-pre~æd ~l~mhr ~ aD

~doscopei to p~ace th~ a~ ~ p~alb ox~aDted n~p~ zod ~ adjacent to ~ ~e~ Ph~ly, ~he f~t i~ie chamber 2S infla~ed into a fi~lly~xpa~ ~n 35 to ~ac~ the or~a~. T~e xc~ med~d e~a~le~ the par~ o~ the elrvelopo ~f the firs~
i~atable chamber cav~ ~ ~e nf~-~u~d chamber to be pl~cod acc~y relati~e ~o ~e org~ ~ ~e trea~ 5~t ff~

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21~714 .
An ~nfla~ble ~e~ac~ ~ a~r~in~ to a ~ d a~cct o~ ~n c~mpri3es an eocpanda~le c~ge ~ C~L s~ ~ugh wbich a~ i~mont ca~l pas~. ~e appa~s add~lly ~mpri~es a main~blc c~ambOE ~av2~g ~m enYelapc of aD da~tomedc mat~l, ~nd a me~ ol~oly i~fla~g ~ ma~
S i~fla~le chambe~ ~vh~ ~ place witbi~ ody ~o ~act the or~an into a re~ted cham~r; i~ expa~, at lcast ~y, b~ l~ng. the mam ini~atable cllambcr; an~
def~.a~ '' '" ' '' 10 lil a ~rst Yaria~o~ an the ~Ja~le re~ dcvicc ~cord~g ta t~e secoDd a~ect of the i~ ~, thc ~b cagç is an addi~al i~a~ble chambær that ~8 ~ cage-lil~e ~troc~ and is indepe~ t af thc ma~ll ~le chambol. ~hc ma~ i~la~e c~mber is rcmoved anc~ db4 ad~nal i~ta~ chambe~ h ir~lai~d and ~he tissac i~
~eated usin~ ~ pasud ~ ~he exrandab~ ~agc. The addî~o~ fl~ble 15 c~ p~bly deployed on:~o ou~idc ~ thc ma~n i~ble cham~er, b~t can ~ a sccond ~ ion, tl~ e~par~bl~ cage i~s a str~ of a malle~ ~etal or pl~ c d~d ~ idb o~ ~e ma n mfl~le c~ e e~ndable cagc ~amber can b~ defla~ed: and ~20ved, a~d the ~?a~dabl~ e :maintai~ the o~

I~ ~ ~net~d acc~S ~to the~L~ven~on of u~g an i~ ~n de~
acco~5~to thC ~I ~spect a~ the ~Dven~on, the m~i~ a~ h ~. I~ fl~bb:~ber i8 i~fIated to ~a~ the ~ga~ a ~t co~on, ~ I~e mainbinçr is~:e~dcd to m~in ~he o~n in its rc~xl c~ndi~i~

` ~: 30 The G0~ f~ ble ra~on ~ &scr*ed i~ the pre~est appliaiiion aDd i~ pn~ appli~.~ be ~ by ~g ~he ~d~al ~g ~eS it caJI oD~y be~ade sn~ ;f it~ h îs i~sed In a ~ethod 35 chamb~ IB inCl~ased ~)y fil]iDg it w~th a solid ins~ad of a fl~id. 1~ t~e me~bod : ~ r~don device ~9 i~l~cd. Ihe ~ilional i~ble ch~m~ of the inflalab~

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re~on ~ is the~l filled ~ith a slu~y c~m~ng a par~uIa~ ~oL;d i~ a liq~

cl~mpor~t ~f ~e sI~ i~ ~noved from ~e a~di~l infEa~le ~umbe¢~ lea~mg the par~cu~ solid ~d. ~ally, t~ p~ o solid is compa~cd t~ f~cm a ~gid 5 swc~3rc m the addi~ l in~b~ chaml~cr. Irl the prefe~ed elnbadim~t, the p A~ative ways of c:5m~g the pa~1ate solid include heating and Goo~i~g tbe 50~id , '- ~
.4 sel ~ endos~ ~rd~g to thc f~h a~pect af tho ~IIYen~o~ ~nabl~
10 ~ndosc~pic o~s~a~ons to be G~ied out i~ ie body w~ the need for a sep~a~e ~et~on de~ . Acoordi~g ~ tho f~urth asp~t of the inve~n, a se~f-re~g endo~pe for o~serving a dssue ~side dle body i~cludes a~ opd~l devioe for obsu ving th~tissuc. l~ caldevicehas a cy~drical str~, and adis~l e~d 1~ ~acludes a ~or ~u is ~nble ~o rc~ct organ~ adJace~ to ~o ~s~uc tha~ woul~
~w3se ~b~ct ~ v~ew of ~he ~ue. I~e ~actor ia a~ached to ~e op~i~1 de~
~ace~t :o the dis~l c~d ~ ~ ~ic~l d~ice a~d Lg ir~ a c~psed s~e wken tiie dis~l end o~ the op~cal devic~ ~s iJ~ser~d into the bo~y. Tho ~r is ~panded o~ce the distal e~d ~ the op~cal dc~ i~ i~side ~e ~y, adjac~rlt ~ the ~ssue tQ bs o~os~fed.

2~ In the pr~fer~d anbo&e~ ~ ~ ~ flatabb, and i~ e~ded by in~ti~g it.
~e ~ a~ f th~ i~n~olt e~able~ a substaDb~cy~:al obie~, ~ch as a~

bu~ng ~r jamming~ :~A~ i~on ~ube a~ordmg io the fi~ ~spect af the inve~on cxnpsisa a~ elo&ptetu~u~ar~mb:ba~g a ~. Thebore recerve~ jcct, such the pn~1dm31 es~d of ~e ulbular m~b. ~ T~s 8~iDg ~paS~il~ insite ~e bore i~ capable of a~t t~ ~ p~ c~ af ~e objoc~
In a melbd ~ to~ in~ion ~ ~ng ~e i~D~ ~bc acco~ding ~ the d of ~e ol~jectt ~nd tho ~s~ eDd a~o obiect is iDser~d iDI;O the p~o~l ~d a~the the tllbU~ m~. l~C di8~ ald Q~ 1ar member is i~d into th~
; ~ :~:~. Th~ ~ ~4 to thepw~i e~d a~thc hlbul~ mcmber is pu~d ~ ~raw :~ :

w~ g2/212g2 2 17~ 9 7 1 4 Pcr/us92/04393 B~ief Descriptio~ Or the Drawirlgs Figure 1 shows a cross sectional vi~ew of a Type IIIA in~atable retraction device accord;ng to a first aspe~t of the invention in its ir~a~ed condition in the abdome~.
S Figure 2A is a cross sectional view ~ow~ng details of the n~n-pressurized chamber and the second i~atable c~amber of a Type IIIA inflatablo retraction device accordiug to a first aspect of t~e invention.
Figure 2B is a cross sec~onal v~ew sbow~g a version of the non-press~zed ch~nber in which the par~ of i~s envelope contacting the envelope of the ~rst 10 inflatable chamber is removed.
Figure 3A is a cross sectional view show~n~g the non-pressur~zed chamber and the second in~atable chamber of a Type IIIA inilatable retr~ction device according to a first aspect of the invention in which the second inflatable chamber is iDside the ~on-pressurized chamber and has its own envelope.
15 Figure 3B is a cross sectional view show~ng the non-pressurized chamber ~nd the second in~atable chamber of a l~pe IIIA inflatable retTaction device accordi~g to a ~rst aspect of the in~ention in which the second inflatable chamber is ~u~side the non-pr~ss~d chamber and has its own envelope.
Figure 4 is a c~oss sectional view of a Type mA inflatable re~action device 20 ~ a~cording to a ~t aspect of the i~vention in its infl~ted condition in the abdomen and hav~ng ducts through which ins~uments can be inserted into the non-pressurized chamber from outside the in~atable retraction device.
Fi~e S is a ~cross sectional view of a Type mB inflatable retraction device according ~ a f;rst a~pect of the ir~ventioll in its inflated condition ~ the ~25 abdomen. ~
~ Figures 6~ through 6C-show cross sectional views of the abdomen including . the bowel, the liver, and the gall bladder to illustrate a first method according to ~he iIlventio~ of using a ~pe IILA or a ~pe mB in~atable retra~o~ device - according tv ~e invendon to retract ~e bowel and lift the liver to gain access30 to treat tbe gall Uadder~
Fi~ure 6A :shows a packaged Type IIIA inflatable retra~ion device in its collapsed state inserted~ i~to the abdomen.
: Figure 6B shows the Type IIlA imlatable retraction device following inflation of the first i~flatable ~hamber to retract the bowel~ t the liver, and3S gain aceess to the gall bladder.

W0 ~2/21292 ~ ~ 8 PCr/US92~04393 Figure 6C shows the Type mA in~atable retraction de~ice following in~ation of its second in~atable chamber. An endos~ope and a cutting iDstrument has been inserted into the no~-press~d chamber to cut an aperture in the envelope of the main inflatable chamber through which to 5 treat the gall bladder.
Eiigures 7A ~hrough 7E illustrate a second method according to the invention of using a ~pe 3mA or a ~pe ~ inflatable re~raction device according to tbe invention to retract a~ organ:
Figure 7~ is a cross sectional view of a partially in~ated Type IILA
10 in~atable retra~on device according to a f~rst aspect of the invention being attached to an endoscope prior to packaging the inilatable retracti~n de~ice.
Pigures 7B through 7E show CI'QSS sectional views of the abdomen including the bowel, the liver, and the gall bladder:
Figure 7B shows a packaged Type IIIA in~atable retraction device attaGhed 15 in a collapsed state to an e~doscope prior to insertion into the abdomen.
Figure 7C shows the packaged Type IIIA inflatable retraction de~ice attached in a collapsed state to an endoscope after it has been ~erted ~nto the abd~men and thé ~ end of the endos~ope has been p1aced adjacent . to the gall bladder.
20 . ~ Figure 7D sh~ws :the Type IIIA inflatable retraction device attached to an endoscope ~ter the second inflatable chamber has been in~ated, and the endoscope has been mal~ipulated to align t~e treatment w~ndow iIl the second in~atable chamber ~nth the gall bladder. - .
Figare 7E shows ~e T~e IIL4 i~flatable retracdon device attached to an 25 endoscope aftçr: the first~ atable ~hamber has been inflated to retract the .- . ~ .. bowcl,: ~ the~ liver~ and provide access to ~reat th~ ~gall bladder.
- - . Figure 8~ is a schematic representatio~ of a Type IV inflatable retra~ion d~ce according :to a second aspect of the inve~ion.
Figure 8B is~a.perspective view af a Type IV~ iDflatable retraction device 30 accordiDg to a se~ond ~aspect of the inveIltion~ having an external i~atable rnailltai~er. ~
~ igure 8C is a ~ut-away perspe~ive view of a Type IV~ in~atable retraction device according ~o a second aspect of ~he invention having an interna~ atable maintainer.

wo 92/212g2 2 1 0~9 7 ,1 4~ PCT/VSg2~04393 9, Figure 9A shows a Type IVA inflat~ble r~tractioIl device unth an in~atable maintainer according to the inYention in its paekaged sta~ prior to insertion in~o the body.
Figures 9B through 9E show cross sectional views of the abdomen including S the bow~l, the liver7 atld the gall bladder to îllustrate t~e method ac~rding to the invention of using a l~pe IVA inaatable retraction device w~th all inflatable maintainer according to the inve:~tion to r~tract the bowel and lift the liver to g~ access to treat t~e gall bladder:
Figure 9B sh~ws a l~pe IVA in~atable retractioll device after the 10 in~atable chamber has been inflated to retract the bowel and lift the liver to pro~ide access to ~eat the gall bladder.
Figure 9C shows the Type IV~ atable retraction device after the maintainer has been inf~ated.
Figure 9D shows the Type IVA in~atable retraction dev~ce after the main 15 in~a~able chamber has been deflated~
Pigure 9E shows ~he in~atable ma~ntainer of a Type IVA in~atable re~ac~ion device in plase iIl the abdomen maintaining the bowel i~ its re~acted conditi~n aIId dle liver i~ its lifted co~dition after the in~a~aUe - retractor has :bee~ removcd f~om the abdomen.
20 Figures lOA through 10E illustra~e a Type IVB inflatable retraction device according to a second aspect of the~ invention having a mechanical maintainer.
Figure lOA is a perspectiv~ ~iew f the maintainer.
Figure lOB is a ~rspecti~e ~new of the in~atable retractor.
Figure lOC is a perspec~ve ~iew of the assembled Type IVB inflataUe 25 ; rctrac~on dc~nce ~ prior to: insertion~ to the ~ body. t '. ` .- - Figurei lOI~ perspec~ve view- of the maintainer in its expanded co~dition following:withdrawal~of ~e infl;table retractor, Fig~res llA ~rough llD show a ver~ical cross sectional vi¢w of a Type IA
atable ret~action devi~e ::to illustrate :~e high-strength inflation met~od 30 ~ccording to the LM~ention.~
Figure 1lA shows the infla~able retraction deYice a~er its additio~al - i~atable cham~er has be~n filled with a slurly of a par~iculate solid in a liquid.
Figure 11B shows the in~atable retraction ~evice after the liquid 3S component of the slurry has been removed its additional inilatable chamber.

wo 92/21292 ~ ) 9 7 ~i 4 Pcr/uss2/o43s3 Figure llC shows the i~atable r~traction device after its additional in~atable ~hamber has beeIl evacuated to consolidate the particulate solid.
Fi~ure llD shows the inflatable retraction device fitted witb an alternative provision ~or oonsol~dating ~he particulate solid.
5 Figures 12A through 12G illust~ate a self~retracting e~doscope according to a fourth aspect of the invention:
Figure 12A is a perspective ~riew of a self-retract~ng endoscope hav~ng an inflatable retractor comprising a stack of toroidal balloons. I~he in~table retractor is shown in its e~panded condition.
Figure 12B is a cross sectional view of an alternative configur~tion of the inflatable retractor.
Figure 12C is a perspective view of the self-re~racting ~ndosc~pe with its inflatable retractor in its collapsed colldition.
Figure 12D is a perspective view of a variatio~ of the self-re~racting endoscope having an i~flatable retractor with the in~atable retractor in its collapsec1 condiffon. ~ variation ~as a substaIltially constant diameter circular cross section and is especially suitable for use in msuf~ated body cavitîes.
Figure 12E is a ~oss sectional vi~w of the abdomen~shounng ~he bowel~
20 ~ the liver, ~he gall bladder, and the self-retract~Ilg endoscope with an in~atable retra~or retrac~g lbe liver to observe the gall bladder.
Figure :12F is a perspective view of a self retracting endoscope according to tl~e in~endon having a mschanical retractor w~b the mecbanical retractor ts co~llapsed condition, : : -2S Fguré 12G is a perspective view of the self-retracting endoscope having a .. ~ mec~ani~ r~ac~or:with the mei~ha~ical retractor i~ i~s expa~ded co~ ion.
~igures 13A ~raugh ~13C illustrate aIl inse~tion tube according~to a ~h aspect o éhe inYe~io~

3 ~ Figure 13A is a perspeictive view of a most b~sic inser~on tube.
~: 30 Figure 13B is a perspective view of a less basic ~nsertion ~be having an - eyelet.~
Figure 13C is a~perspec~ve view of an improved vi~rsior~ of the insertion tube having aIl exte~ l na~Tow bore tube~
Figure 13D :is a perspective view of an improved version of the insertion tube having an internal narrow bore tube.

wo 92/21292 2 1 O 9 7~ . P~r~Us92/o43~3 D~tailed Descr~ptiol~ of the ïrl~ention 1. TYPE ~ INFLAT~BLE RErRAcrIoN DEVIC~S
(a) Type IIIA J~nflatable Retraction Demce Figure 1 shows a vertical cross sectional view of a retra~tion devi~e according S to ~he first aspect of t~e invention. This ~ype of retraction device ~as a second in~atable chamber that expallds a non-press~d ~hamber into an e~anded condition when the second in~atable chamber ~s inflated, and u~ill be designatedas a Type m retractioll device. ~e Type III in~atable retra~tion device show~
i~ figure 1 with a segmented non-pressurized chamber w~ll be. designated as a 10 Type IIIA in~atable retraction device. The inflatable ret~action device 1 is shown in its in~ated condition. The in~atable retraction device 1 comprises a hrst envelope 3 enclosing a first in~atable chamber 5. Inside the f~rst in~atable chamber S is the non-pressunzed c~amber 13, which is maintai~ed in an expanded co~di'don ~y tbe seco~d inflatable chamber 25.
15 The i~atable retraction device 1 is shown being used in the abdomen A to re~a~t the bowel B, lift the liver L and provide access to treat the gall bladder GB. After the inflatable re~actio~ device 1 has bee~ deployed, an aperture 4 is cut in: the tr~atme~ window 6 to gain access to ~he gall bladder GB. The ~e8 window is the pa: of ~he ~t envelope 3 covered by the non-20: . pressurized chasnber 13. ~ Alte~n~tively, the infla~able retrac~ion d~vice 1 may besupplied with the :apertNre 4 ~eady cut in the treatment window 6. The non-pressuri~ed chamber 13, supported by ~he~second i~la~able chamber 25, isolates ~he aperture 4 ~ :the first i~atable chamber 5. ~his enables the first atable chamber:~to:remain inflated and to continue to prwide retraction ~ the 25 . bowol B. Because~of the aperhlre 4, ~he iIlterior of the non pressu ized chamber . . .13 is at atmosphedc pressure, or, if the ab~omerl A is insufflated, at thç ambient .prgssure of t~le abdomen.: .
~struments, such as the endoscope 33, pass into the first inflatable chamber : ~ 5 through :the :gas-tight port: 9 o~ the first inflation tube 7~ and thence through the ~30 gas-tigb~ port 31 i~to ~he non-pressunzed chamber 13 to observe or to t~eat the - ~ . gall bladder GB. Addido~ally or alternatively, instruments, such as the forceps ~, can pa~s ~brough the gas-tight port 32 into the first inflata~le chamber, andtheIIce ~hrough a gas-~ight por~, such as the port 36, into the non-pressurized 2 1 0 9 7 1 ~ 12 Pcr/~S92/0~393 chamber. The gas-tight ports 9, 31, 32, and 36 enable the first in~atable chamber to remain inflated.
The first envelope 3 of the inflatable retraction device 1 ca~ be made of a relatively inelastic alld tough film of a plastic such as Mylar0 or polyethylene.
5 The pre~erred relatively inelastic material is a polyethylene and nylon composite with a thiclmess in the range from 0.5 to 5 Ir~ls (13 to 130 microns). Alternative-ly, the first en~elope ~n be made of an elastomeric mate~ial such as latex, pc~lyure~hane, or silicone rubber wi~h a thich~ess in the range from 0.5 to 5 mils (13 to 130 microns).
10 The proximal end of a first in~lation tube 7 is sealed into the ~rst envelope3. The hrst inflation tube 7 allows an inflation gas to pass in~o a~d out of thefirst in~atable chamber 5. The in~lation gas is typically air, ~trogen or carbondioxide, although other suitable gases may be used. Typical infl~tion gas pressures are in tbe range 0.2 to 0.4 pounds per square i~cb (psi) (0.14 to 15 0.28 kPa), the preferred pres.sure being 0.3 psi (0.21 kPa). The first infl~ion tube 7 is provided w~th a gas-tight port 9 on its dis~al end, through which endoscopes and/or surgical instruments can be passed illto the first in1atable chamber 5.
~e port 9 allows the ~ation pressure of the first i~atable ~hamber 5 to be maintaiDed when surgical i~truments are passed through it.
20 Tbe first envelope 3 of the~ Type IIIA inflatable retraction device can be a polyhe~ structure cons~ ed from two se~nented, substantially flat pieces of matenal, whi~h gives the i~la~ble retraction device a substaJltially polyhedral sbape. Alternatively9 the in~a~able re~action dev~ce can be constructed ~m one or more curved pieces of plastic film, which give~r~he inflatable retr~ction device 25. : a subs~ata~ally: spherical,~ spheroid~l~ or ellipsoidal shape, as sh~wn in figure 1.
--- ~e size of i~flata~le: re~rac~ devices according to the inve~tion caD range ~om aboilt 2" (50 mm) wide by about 0.5" (12 mm~ high, ~or use inside the perica~dium, to 10"-14" (25~350 mm~ wide by 4n-8" (1~200 mm) high9 for use in the abdominal ca~iqO The size of inflatable retraction d~vice required ~or a 30 - gi~en application depends:on the applica~ion and the size of ~he patie~t.
The second envelope 11, which bounds the non-pressllrized ~hamber 13, is pr~e~ably made~ ~om substa~tially the same thiclaless of the ~ame material as the firsS e~velope 3. H~wever,~in some applications it may be advantageous make the second envelope 11 using a di~erent thickrless of the same matelial as the iirst35 e~velope, or using the same or a different thiclcness of a different material.

210971~
W~ 92J21292 . ; . I . ; Pcr/uss2/o4393 The second envelope 11 can be a polyhedral structure corlstructed ~om tWD
segmented, substantially flat pieces of material, with the edges of the segmentsjoined to give the non-pressurized chamber 13 a substantially polyhedral shape.
Altematively, the non-pressunzed chamber 13 ca~ be constructed from one or 5 more curved pieces of material, w~ich gives the non-pressurized chamber 13 a sllbs~tially spher~cal, spher~idal, or ellipsoidal shape. This form of cons~ruction is particularly appropliate i an elastomeric material is used for t}le second en~elope 11.
Despite its name, the non-pressur~zed chamber may be briefly ir~ated to assist 10 in expanding ig from its collapsed condi~ion to its expanded condition against the pressure e~erted OII it by ~he first inflatable chamber 3. If the non-pressu~ed ehamber is to be inflated~ i~ is provided with the second inflation tube 15.
The peApheIy 17 of the third envelope 19 is attached to t~le second envelope 11. This is shown in detail in figure 2A~ The third envelope is preferably 15 at~ached to the inside surface 21 of the second envelope. The third emelope 19 has a segmented shape such that, when its periphery 17 is attached to the se~nd envelope 11, and the second inflat~ble shamber 25 formed be~Nee~ ~he seco~d eIlvelope 11 and the third enYelope 19 is inflated, the second in~latable chamber 25 fo~ns a cage structure ~nside or outside the non-pressurized chamber 1~.
- 20 Figure 2A sbows ~e seoond inflatable chamber 25 ~ormed` inside the non-pres~ed c}l~nber 13. Alternatively, the third en~elope may be a~tached to the outside surfa~e 23 of the second envelope as shown iI! figure 1. When the non-pressurized cham~er 13 is a polyhedral s~ucture, the cage struch~re o~ the second in~atable cham~er is preferably formed on the ~aces o the polybedron.
: .~,X5 The third i~flation: tube-35 allows aIl ~ation gas ~o pass into and out of the second ~atable chamber 25. The inflation gas is t~pically air,~ ni~ogen or : - - carbon dio~ndej~:àlthough other~suitable gases may be used. Typical in~ation gas pressures are in the ra~ge 2 to ~ psi (1.4 to 3.5 kPa), the p~eferred pressure beirlg 3.5 psi (2.4 kPa). The inflation~gas pressure in the second in~atable 30 ~chamber 25 is coDsiderably higher tharl ~at in the first i~atable chamber 5 to enable the second inflatable chamber to exert suf~cient force to sapport the non-pressuri~ed chamber 13 aga~nst the pressure exerted on it by- the in~ation pressure in the first in~atable ~hamber.
In an embodiment of the Type IIIA retraction device designed ~r use in an 35 insufflated body c~vity, the second in~ation tube 15, if i~ltted, and the third 2 1 0 ~ 7 ~ ~ 14 pc~r/uss2/o4393 in~a~ion tube 35 are contained liv~thin the first in~ation tube 7, a shown i~ figure 1. The outer wall of the f;rst inflation tube 7 forms a gas~ t seal unth the trocar tube or introducer sleeve t~llgh which the first in~ation tube passes into the body. Alternatively, the three in~ation tubes ean all be mounted in a tube S sheath that forms a gas-tif~t se~il with the trocar Lube ~r introducer sle~ve through whic~ the tube sheath passes ~nto t~le body.
Figure 2A show~ the second in~atable chamber 25 fo~ed between part of the second envelope 11 and the third envelope 19. Figures 3A and 3B illustrate a~
alternative embodimeJlt in which the third envelope 19C is formed into a geodesic 10 tubular struchlre that provides the envelope for the second inflatable chamber 25C exclusively. In iigure 3A, the second inilatable chamber 25C is formed inside the non-pressu~ed chamber 13C. In thIs configuration, there is no Ileed to attach the second inilatable chamber to the inside surface 21C of the second envelope 11C. In figure 3B, the xec~nd inflatable chamber 191:) is attached to the 15 outside surface 23D of the se~nd envelope 11D.
Although providing the second infla~able chamber with its QWIl envelope, as showII in ISgure 3C, increases the volume of material used for the third envelope l9C, it e~ables a c~siderably ~er material to be used for the second envelope 11C aIld :t~us gives in a overall reducdon in the collapsed buLk of the20 . i~atable rebra~olli,d~ice. :A ~hi~er material.ca~ be used for ~e second envelope because the :second envelope is subject only to the in~ation pressure of the first inflatable ch~ber SC, and is not subJe~ to the much higher inflation pressure of the second in~atable chamber 25C. This alter~ative fo~ of construction is especially preferred when an elastomeric material is used for at25 least -part of -tbe ~se~nd- envelope 11C. The~ foregoing ~lso applies.to the . ~ embodime~t shown in figure-3D.- ~ ;sj -~
art of ~the outside sur~ace 23 of the seoond envelope is at~ached ~o the iDside .; sur~ce 27 of the f;rst envelope 3, as shown in i~gure 2A. ~he part of the ~rst eIlvelope ~co~ered ~by~ ~he no~-pressu~zed chamber 13 pr~vides ~the treatment 30 ~ window 6. . The second envelope 11 may be left inta~t o~er ~e ~eatment window 6:, in .w~ic~ case ~her~ is a:~double thickness of ~ material cove~ing ~e trea~ment .~ window 6, as shawn in figure 2A. - Alterna~ively9 as shown in iigure 2B, part of the second envelope 11B may be remov~d, s~lch as one face of the polyhedron if the no~-pressurized chamber is a polyhedron, to avoid a double thickness of WO 92/21292 ' 2 1 0 9 7~ PC~/USg2/04393 material over the treatment window 613. In either case, the second envelope mustbe attached to ~e first envelope to folm a gas-tight seal between them.
The parts of the second envelope 11 not obstructed by the second inflatable charnber 25 pr~vide a plural~ty of windows 29~ ~s shown in figure 1. At least one S of the windows is fitted uith a port 31 which enables a surgical instrument to be passed from the first i~flatable chamber S into the non-pressunzed chamber 13.
When an instrument, such as ~be endoscope 33, is passed throug~ the port 31, the port forms a gas-tight seal with the instrument. When the instrument is withdrawn from the port 31, the port once more fonns a gas-tight seal with itself.
10 The port 31 provides a gas-tight acoess from the first inflatable chamber 5 to the non-pressurized chamber 13 that maintains the inflation pressure in the first irLllatable chamber. The port 31 preferably includes a window of an elastomeric mater~al such as latex, poly!lret~ane, or silicone rubber. A slit ~nay be pre-cut in the window to make it easier to pass inst~uments through the window.
15 As an alternative to the port 31 shown in figure 1, an instrument may be passed directly through the window 29 if at least the part of the second envelope folming the window 29 is of an elastomeric material.
Figure 4 shows a~ alternativc to usLng some fonn of port between the first inflatable chamber and ~the ~non-pressurized ~chamber to allow a surgical instmment :2 Q to be passed into~the non-pressurized~chamber. In figure 4, features similar to those in figure l are indicatcd by the~same reference number with the letter "A"added. The inflatable retraction device lA is provided with a duct 37, which is a tube of all inelastic; plastic~ Dnaterial similar to that which may be used for the first envelope 3A.~ ~ The duct 37 is ~sealed into one of the windows 2~A iII the25 ~ ~second ~e nelope 1LA, passes pr ximally through the first in$1atable chamber SA, is sealed through the first e~nYelope;~3A, alld extends beyond the iirst envelope as ~hown.
Aiter the inilatable retraction~ device lA has been depl~yed, an incision I is made ~ll the ~abdon~inal wall BW, and the pro~mal end of ~he duct 37 is brought out through the in~ision ~ ~e duct 37~ provides ~a passage at atmospheric pressure through which a~ sur~cal r~strument can be passed from outside the bodydirectly into the nou-prcssu~ized chamber 13A, and thence ta the gall bladder GB.
rangement provides bener feel for the surgeon because movement of ~e ins~umerlt is not restricted by the two gas-tight ports 9 and 31 (figure 1).
~; 35 However, ~he duct 37 must be fitted with a gas-tight port if the inflatable 2 1 d ~ 7 i 4 1 6 PCT / us92/043~3 retractio~ device lA is used in arl insuf~ated body cavi~ to prevent insuf~ationgas from leal~ng out through the duct. In~atable retraction devices according ~othe invention may bave both ports and ducts.

~b) Type IIIB Inflatable Retra~tion Device S Figure S shows tbe Type II~ atable retraction device 3~, which is a va~iatio~ on the Type m~ atable r¢tractio~ de~ice havi~g a difeerent structl3re for the ~o~-press~ed chamber a~d the second inflatable chamber. In i~gure 5, t~e first i~flatable chamber 57 is subs~antially the same as t~e Srst in~atable ~hamber S shown in figure 1 and will t}~erefore ~ot be described further. The polyhedral or substantially spherical or spheroidal non-pressu~ized chamber 13 of figure 1 is replaced by a substantially cylindrical non-pressurized chamber 41.
The part of the iirst envelope 55 of the first inflatable chamber covered by the nonpressurized chamber 41 proYides a treatment window 60 in which an aperture 61 can be cut to gai~ access to the tissue being treated? ~ this example, the gall bladder GB. ~e nor-pressurized chamber 41 enables the ~rst inflatable chamber 57 to remain in its inilated state, and to conti~ue to pro~ide retraction, de~pite the presen~ of an~ aperture 61 in tbe treatmens wiIIdow 60. The ~on-pressulized chamber :41 is enclosed by part o~ the third eIlvelope 51, the treatment wi~dow 60, and the diap~agm S9~ e diaphragm is preferably made of an elasto~eric mate~ such as l~ex, polyuretharle or silico~e rubberO
l'he seco~d inflatable cbamber 43 compr~ses a stack o~ toroidal balloons which is enclosed: by the ~d envelope :$1. A:stack of ~ee toroidal balloons 45, 47, and 49 is shown: ~a~greater or;lesser number of toroidal balloons ~n be used, ~depelld;ng on;the application. ~The second in~able chamber-43 is attached to t:he i~e~ surfaco ~53 ~of ~e~-~irst e~elope 55 of the first in~table chamber 57.The third envelope Sl of ~he inflatable retraction d~ce 39 is ~de of a relatively-inelastic~ and tough iilm of a plastic such as Mylar~, polyethylene, or polyuredlane. The ~preferred ma~erial for the third envelope 51 is a polyethylene and nylon c~mposite. ~e ~thichless of the thi~d erlvel~pe 51 is ~pically from 0.5 t~ 5 mils (~13 to~l30 microns).
The no~pressurized chamber 41 can be briefly inflated by means of a second i~ation tube (not shown) to assi~ i~s initial expansi~n, as already descnbed. The second in~atable chamber 43 has a third iI~flation tube (not shown) sealed into i~ If a stack of toroidal balloons 45, 47, and 49 is used ~or the second inflatable W092/2l2g2 2 1 09 71 ~ ~ ~ Pcr/uS92/~4393 17 t r ~
~hamber 43, as shown in figure 5, t~ey may simply be interconnected, and a single third inilation tube used. Alternativel~, a third inllation tube rnay be fitted to each ~oroidal balloon to allow the height of the non-pressurized chamber to be adjusted by selectively in~ati~g the balloons i~ the stack. In a further alternative, S a single ~îrd in~lation tube ~ feed a manifold leading to each balloon througha llon return valve. All balloons in the stack are in~ated initially. The beight of the non-pressunzed chamber 41 can then be reduced by punctur~ng one or more of the balloons.
The diaphragm 59 provîdes one large window through which aII instrwnent, 10 sucb as the endoscope 63, may be passed from the first inflatable ~hamber 57 into the non pressunzed chamber 41. Gas-tight seals must be provided around such instruments. Using an elastomeric material for the diaphragm 59, or using a subxtantially inelastic material for the diaphragm 59 a~d ~Itting a port 65, similar to tbe port 31 in iigure 1 will provide suitable gas-tight seals. Alternatively, a 15 duct, similar to the duet 37 of figure 4, can be used in the retraction device 39 of lïgure 5, preferably attached to the diaphragm 59~ to provide a passage at atmospheric pressure from outside the body through the first inflatable chamber to the non-pressu~ized chamber 41.

(c)~ Fi~t ~hod of Use :~ ; - ; -20 ~ In the following description, the ~word "organ" will be used to mean an organ :
or a tissue that is re~acted by the inflatable retraction device. The word "treat"
u~ill be used to mean both treat and observe, and the word "trea~ent" will be :
used to mean both treatment and observadon. The word "tissue" or the phrase tissue to be tr~ated"~ will both be used to mean the organ or the ~;ssue that istreated t hrough; or iDside~ the retractio~ device. - ~-ib;~ ,Figures 6A through 6C show cross sectional elevational views of the abdomenA to illustrate the~:method~by which a~Type IILA- inflatable retraetion device according to the inYention is ùsed in the body to retr~ct an organ within the body to g~ ~access ~to treat a tissue. I n the method il}ustr~ted in Figures 6A through 30 6 C,~th~ inflatable retract;on device is inserted into the abdomen A and is used to retract an organ, the: bowel B, to 8ain access to treat a tissue, the gall bladder GB. The in~atable r~trac~on device alsv lifts the liver L ~he metbod according to ~he iIlvention can also be used to deploy a Type IILA in1atable retraction ; W0 92/21292 ~ 2 1 d ~7't'4 i' ~ ` 18 PCI~/US~2/04393 device in other par~ of the body, and to deplo~ a Type IIIB in~atable retractiondevice in the same or in other parts of the body.
The in~atable retraction device 1 is supplied in a collapsed state 91, as shown ~ figure 6A, in which it is tig~tly packaged in a con~guration that makes it S essentially a linear extension of tbe first inflation tube 7~ The collapsed i~flatable retraction device is introduced ~nto the body by pushing it through a suitable introducer sleeve or trocar tube T ~bat has been inserted through a suitable ~ncision I1 ~n tbe body wall BW. Alternatively, an introducer tube accordi~g to the fourth aspect of the invelltion, to be described below, can be used. The 10 trocar tube T is oriented so that, when the collapsed inflatable retraction device 91 is ejected f~om the trocar tube T, it is located adjacent to the organ as s~own.
The location of the collapsed retraction dev~ce is checked by an endoscope S
inserted into the body through a second ~ncision I2. Once the collapsed retraetion device 91 is cvrrectly located, it is released from its packag~ng.
15 Tbe iïrst in~ation tube 7 is connected to a source of inflation gas (not shown) and the gas supply is slowly turned on to in~ate the first inil~table chamber 5.The first in~latable chamber slowly expands, as shown in f;gure 6B, progrcssively retracting the bowel B and li~ing the liver L as its size ~ncreases. Throughout the e~pansion process, the iirst inflatable chamber S presents a relatively lalge 20 surface area to the bowel and the liver, and thus retracts the bowel and lifts the liver gen~y? pro~essively, and: without trauma. Although the ~rst in~atable ~: chamber S retracts ~he bowel and lifts the liver gently, it is capable of exerting the force necessaTy.to effect the retraction of the bowel a~d the lif~ng of the IiveL
Once the first iD~atabh chamber 5 has reached its fully-inflated ~ondition, the posi~don of the ~eàtment window 6 rela~ive to ~e tissue is c~ecked by observation . .through the endoscope S a~d/ar an endoscope (not sh~wn) inserted into! ~e iïrst iDflatable~ chamber 5~: ~ough; the first in~ation tube 7 and the gas-~ght port 9.
~: . ~e ~ue to be:~treated ::must be substantially centered in the t~eatment window 3 0 ~ 6. If .the in~atable re~action ~deYice 1 is supplied ~nth the aperture 4 already cut in the~ tre~ment ~window ~ ~he aperture 4 must be substa~tially centered on the tissue to be treatéd, i.e., the gall bladder in this ~xample. lf tbe in~atable retraction de~ce ;1: is not correctly positioned, the in~ation gas pressure is reduced slightly to partially de'date ~he ~rst in~atable chambe~ and the inflatable retraction WO 92/21292 ,~ I ~ 9~ 7 ~ US92/04393 device 1 is ma~ipulated to c~rrect its orielltation. The lirst iD~atable chamberS is then rein~ated.
Tbe non-presswized chamber 13 is next exp~ded. 'rhe source of inflation gas (not shown) is comlected to the second inflatlon tube 15 and the gas supply is 5 slowly ~ed on to in~ate ~he non-pressurized chamber 13 to its fully extended co~dition. An in~ation pressure sligbtl~ greater than that used to inflate tbe ~rst in~atable chamber S is used. The second inflation tube is clamped, and t~e source of inflation gas is tra~sferred to the third inflation tube 35. rhe gas supply is slowly turned on to i~ate the seco~d inilatable chamber 25. An 10 inflation pressure approximately ten times that used to in~ate ~e first in~atable chamber is used. Once the second in~atable chamber is fully inflated, inlla~ion pressure is released ~om the noll-pressurized chamber 13.
Tempora~ly inflating the non-pressurized chamber 13 ~efore inflating the seco~d inflatable chamber 25 is the preferred way of ex:panding the ~on-15 p~essurized chamber. Inflating the non-pressurized chamber first malces it easier to i~ate tbe second inflatable chamber, and enables ~he size of the second in~atable ch~ber to be reduced. More force is required to e~pand the non-pressurized chamber 13 from a collapsed condition against the in~ation pressure - of the f~rst in~table chamber ~ to maintain the non~ressulized chamberin an alread!y-e~anded cond;tion ag~st th~ inflation pressure of the fi~st ~atable chamber. However, inflating the Iwn-pressurized chamber is not essential, and ~e step o~ ating the llon-pressurized chamber can be omitted if desired. I~flation~ cannQt be used to help e~and the non-pressurized chamber if t~e i~atable :retrac~on device 1 is supplied wit~l the aperture 4 already cut in the ~treatment willdow 6. ~
If ~e ~per~re 4 is~ already cut in the ~reatmen~ window 6, treatment of the tissue can begin using o~e or more instruments passed t~rough the gas-tight port9 a~e f;rst in~ation ~ube 7 into the ~rst infla~ble ~hamber 5 and tbence . through ~he port 31 into the non-pressurized chamber 13.
If ~lhe aper~ure 4 is::to be cut in ~e ~reatment window 69 a~l endoscope 63 is passed ~hrQugh the port 9 and the f;rst infl~tion tube 7 into the first i~atablecham~er ~,~ and from ~he hrst ~ atable chamber S through the gas-tight port 31 into the nQn-pressurized chamber 13. A cut~ing instrument 67 is ~hen passed intoth~ iirst inflatable chamber thr~ugh the gas-tight port 69, and f~om the ~rst i~atable charnber to ~he non-pressurized chamber through the gas-tight port 71.

WO92~21292 t ~ t,~ ~ P{~/US92/043g3 ~1097~ 20 `) , The ~tting instrumen~ is ~hen used to make a cut in, and possibly to rem~ve partof, the trea~ment window 6 ~o provide the aperture 4. If the second envelope 11 co~ers the part of the first envelope cu~ or rem~ved (see figure 2A), this part of the second envelope must also be cut or removed.
S The tissue to be treated is treated us~ng instruments passed througb ports such as the port 31 into the non-press~d chamber 13. l~e ~nstruments are then passed out of the non-pressurized chamber thr~ugh the aperture 4 to treat the tissue. Alternatively, ~he tissue c~n be pulled into the non-pressurized chamberthr~ugb t~e aperh~re 4 and the treatment can be carried out inside the non-10 pressurized chamber. The edges of the aper~ure 4 form a seal against the tissueand keep blood, debAs, ete. safely inside the non-pressurized chamber, ~om wbence they can easily be removed.
If the in~atable retraction device is of ~he configuration shown in f;gure 4, and has a duct 37 instead of, or ill addition to, the gas-tight port 31, the duct 37 is 15 used to pass the endoscope 63 a~d the catting in~trument 67 into the non-pressulized chamber in the method described above. AlterIlatively9 both ducts and ports can be used.
The need for extensive ~pulation of the in~atable retraction device 1 to c~nter the ~ea~ent window 6 on the tissue being treated can be reduced by 20 providi~g further noll-pressuriæed ch~mbers attached to the first envslope 3. Each ~oll-pressurized chamber pro~des a di~eren~ly-oriented treatment unndow and has its ~wn sec~nd in~ata~le chamber. After the f~rst inflatable chamber S is inflated, the o:l~e or more non-presswized chambers that provide the most favourably ~igned treatmeIlt wiDdows relative ~o the tissue being ~reated are e~panded as 25 descnbed ab~ve, and are used to provide access to treat the ~issue.-:

(dJ : ~Second ~etho~ of Us~
, ~r,~ : " Figures 7B through 7E show cross sec~onal elevzltional views of the abdomen A to illustrate the~seco~d method ac~ording ~o ~he invention of using a Type mA
inflatable :ret~action d~ acco~dirlg to the in~ention to retract the bowel B and~;~ 30 lift the liver L to gain access to the gall bladder GB, as in the first method desc~ibe~ abo~e. l~e same method can be used with a Type IIIB in~atable retraction device, and the method can be adapted for use in -~onnection with ~e~ting other tissues.

i wo g2/21292 2 1 0 9 7 1 ~ Pcr/us92J~43g3 The first metbod of using a l~pe III in~atable retraction device involves a tedious process to align the treatment window 6 with the tissue to be treated.
The second method of using a Type m inilatable retraction device simplifies aligning the inflatable retractîo~ device 1 relative to the tissue to be treated.
S Before the inflatable retraction device 1 is inserted into the bQdy, both ~e lïrst inilatable chamber S and the second in~atable chamber 13 are paltially inflated, and the inf~atable retraction device is assembled witb the endoscope 33 as sh3wn in figure 7A. The distal end of the endoscope 33 is inserted into tbe first in~atable ch~mber S t~rough the first inflation tube 7 and the gas-tight port 10 9. The distal end of the endoscope 33 is pushed through the gas-tight port 31into tbe non-pressurized chamber 13 a~d is centered in the treatment window 6.
Alternatively, a gas-tight port specifically designed to seal with the endosc~pe 33 can be incorporated i~to the second envelope 11 to receive the endoscope. ~e first and second inflatable chambers are then collapsed by evacuatmg them.
15 The in~atable retraction device is then~ wrapped around the shaft of the endoscope 33~ adjacent to the distai end of the endoscope as shown in figure 7B.If an aperture is alrea~y cut in the treatment window 6, the tip of the endoscope is~ exposed. Otb Iwise, the; tip of the endosc~pe is covered by at least a layer of ~tbe first envelope 3, as shown Ln figure~ The collapsed in~atable re~action 20 device 91 is held in position by detac~)able lacing 93. Alterna~ively, the oollapsed ~inilatable ret~on device~ caD be held in position by a sleeve with detachable ; lacing, by a sleeve~ with a tear~ s~ip,; or by another suitable method. The paclcaged assembb ~has an ~verall diameter of about 11 ~ which enables the paclcage to~ fit through a~ 12 mm trocar~ ~be. ~
Before the assembly is illserted into the body, it may be necessary to iDsu~ate the aWomen A~ orarily~to create space in whicli~to m~aneuver the distal end of the endoscope/retractor assembb 95 into proxiII~ity with the ~ssue to be treated. Insuflla~on /techniques lare l~own and ~will not be described. The ~su~ated condition~ is indicated:by tbe.~broken ~line mark~d A' in figure 7B. An30 ins:ision ll is made~ in the~ abdominal ~wall ~;~BW aIld ~ a *ocar tube T is dr~ven ~rougb the wall. ~ ~Tbe~ endoscope/retractor ~assembly 95 is inserted in~o the abdomen tbrough~the t~oca~ tube (and a gas-tight port P on the trocar tube ;f the body ~nq is insufflated). While viewing through ~e endoscope 33, and, if desired, through~ an addi~ional endoscope 63 inserted into ~he abdomen in the 35 vicini~ of the gall bladder GB through an additional incisioII I2, the endosc~pe W092/212s2 ~ P~r/us92/o4393 2109714 æ
33 is manipulated to bring i~s dis~al end close to the gall bladder GB, as shownin figure 7C.
The in~atable retraction device 1 is then released from its pac~caging and the non-pressurized chamber 13 is expanded into its expanded condition as shown in figure 7D. If a~ aperture is not already cut in the treatment windoyv ~ e non-pressurized chamber is preferably expanded by temporarr,ly inflating it using the second inl~ation tube 15. The seoond i~flatable chamber 25 is then inflated withinflation gas through the third infladon tube 35. If the aperture is already cut"
or if the second infladon tube is not provided, ~he non~pressurized chamber is expanded by in~adng the second in~ation chamber 25 with inflation gas through t~e third inilation tube 35. With the non-pressurized chamber expanded, the endoscope 33 is then manipulated, while observing at least through the endoscope33, to center the treatment window :6 on the tissue to be treated, i.e., the gall bladder GB~ The endoscope 33 is then clamped in position to hold the non-pressurized chamber in its correct location relative to the gall bladder when the first inflatable chamber is inflated.
The first in~adon tube 7 is connected to the supply of inflation gas (not show~) and in~lation pressure is slowly; increased to expand the first inflatable ~ chamber 5. The expanding first inflatable chamber gently retracts the bQwel B, -. 20. Iifts the liver L~ and provides a:worlang space in front of the gall bladder GB, - as shown in iigure; 7E.
~ter the in~atable retraction device has been deployed according to the method just described~r~ments are passed into the first inilatable chamber S
and thence into the norl-pressulized chamber 13 to treat the gall bladder as 25 ~ descnbed above.: l`he~ method~described above can also readily be adapted to deploy ~ i~flatable; retraction~ device:~wîth du~ts, as shown in figure` 4.

2. TYPE IV IN~LATABLE ~R~ACrlON DEVIOES -' Figure 8A is a~ ;sche natic--representation of a basic T~e IV inflatable retr~ion d~vice:~according:to the~second aspect of the-invention. The Type IV
:~ 30 inffatable: retraction ~device is ~sh~ in its e~ ded :oondition. The Type IV
infl~table retraction dence lO1 has t-vo main components, the inflatable retractor 103 and the maintainer: 107.: Both the inflatable retractor and the maintainer are : ~ in a collapsed condition wherl the Type IV in~atable retraction device is inserted into the body.

WO 92/21292 2 1 0 9 7 1 ~ Pcr/uss2/o4393 ' 23 , , The f~rst main compo.nent of the Type IV inilatable re~action device, the in~atable retractor 103, has a main inilatable charnber 105 that is inflated to retract ~n organ into a retracted condition. The second main component, the maintainer 107 is expanded, at least pa~tially by inflating the inflatable retractor, S to maintain the retracted organ in its retracted condition and tQ. allow the inflatable retra~or 103 to be deflated and, possibly, removed.
~ e structure of ~e in~atable retractor 103 does not permit instruments to pass through it to treat the tissue. The maintainer 107 has an open structure that enables ~nstruments to pass through it to treat tbe tissue once tbe in~atable 10 retractor 103 has been deflated and, possibly, removed. The maintainer 107 may bave several different constructions that will be described below.

(a) Type IVA ~nflatable Retraction Device Figure 8B shows a Type IVA inflatable retraction device which has an in~latable maintainer 107A. The main in~atable ehamber 105 of the in~latable 15 retractor 103 LS ellclosed by a ~ain envelope 109, which is preferably a balloon of a suitable elastomeric mateAal such as latex, polyurethane, or silicone rubber.
The size and shape of the main in~atable chamber 105 depends on the - application. -For a given inflated size, a main envelope made of an elastomeric materi~ has considerably less collapsed bulk than a main envelope made of a 20 Iwn-elastic material, such as: Myla~0, polye~hylene, polye~hylene/nylon ~omposite, etc. Moreover, the main envelope of a Type IVA inflatable retraction deYice can be ~oDsiderably lighter and thinner tha~ the m in envelope OI a Type I retraction device because it need only remain inflated for a few minutes, and is subject toc~nsiderably lower pressures.~ The main :-i~atable cham~er is ir~lated by an ation gas-passed ~hrough the-main inflation tubè 111. i ;i- ~
he; in~atable main~er 107A showIi in figure 8B is a geodesic structure : ~ ~ formed from a plurali~ of interconnected in~atable plastic tubes 113. Tbe tubes 113 are formed ~om a substantially inelastic plastic material such as Mylar~ or polyethylene, ~r,~ preferably, ~a polyethylene/rlylon composité. T~e hlbes are 3 0 ~ interco~nected~ so that their bores commur~icate, which enables the maint~ner to be in~ated by ~e~ single~ additional inflation tube 115. T~e sIze and shape of the tubes 113 depends on the application. For instance9 a Type IV iDflatable . retrac~or suitable for retrac~ing the bowel and lifting the liver to gain access to the gall bladder has a struc~ure in which the tubes 113 are on the edges of a W~ 92~21292 ' ~ ~ f~ Pcr/uss~ 3s3 2~097~ 24 dodecahedron in the raIIge 8" to 12N (20 ~o 30 cm across. E~aeh tube is 0.4" to 0.8" (10 to 20 mm) in diameter, aald has a wall thickness in the ran8e 4 to 10 m~l. S~.l to 0.25 mm).

(b) Type IVA In~able Retrachon Device - Method of Use S For insertion ~nto the body, t~e ~pe IV~ inflatable retraction device is packaged as follows. The main in1atable chamber lQS of the in~atable retractor 103 is preferably ligbtly attached to ~he maintainer 107A before the in~atable retraction device 103 is packaged ill its collapsed state. This is to ensure that the main in~latable chamber remains inside the maintainer w~en thç main in~latable 10 chamber is in~ated. The main in~atable chamber and the Inaint~iner are is~ated unth the main inflatable chamber inside the maintainer, and are attached to one another using a suitable adhesive, or by we~ding.
The main in~atable chamber 105 and the maintainer 107~ are then both evacuated to collapse them, and then are packaged to form an extension OI the 15 ma~ infla~tion tube I11 and the additional inflation tube 115. The collapsed in~atable retraction device is held î~ its packaged condition by the sleeve 112 with deta~hable la~g 114" as shown i~ figure 9A. Alter~atively, the collapsed retra~on deYice ca~ be ~eld in its collapsed co~dition by detachable la~g, by a sleeve with a tea~ s~rip, or by another suitable method. The packaged assembly20 has an ove~all diameter o~ about 11 mm, which enables the package to f~t thr~ugh a 12 mm trocar tube.
~ igures 9B ~r~ugh 9E illustr~te the method according to the invention of us~g the Type ~VA ~atable retraction device 1û1 in the abdomen A to retract th~ b~vel B a~d to~lift~the liYer L ~o gain a~ess to -treat ~e gall bladder GB.
25 The method c~n also be ~used to treat other~ orga~s and tissues in t~e body.~ The t~ ~ pa~ged in~atable~retraction d~vice 1()1 is inserted in~o the body thro,ugh a suitable troca~ e T and placed adjacent to the tissue to be treated, i.e., the gall bladder GB. The i~atable retraction device lO1 is released ~om the sleeve 112 by pulling OIl the deta~hable laciIIg 114 (~lgure 9A). The main inflation tube 111 30 is connected ~o a source of in~ation gas (not sho~) and the in~ation g~s pressure is ~creased ~ the main in~atable chamber 1~5 begins to e~and.
When the mai~ i~atable chamber expands, it gently retr~cts the bowel B ~d lifts the liver L and also extends maintainer 107A over its sur~ace, as shown infigure 9B.

Wo 92/21292 s 2 1 0 9 7 1 ~ Pcr/u5g2/o4393 When tbe main inf~atable chamber 105 is e~ ded to the limits def~ned by the maintainer 107A, inflation is stdpped, the first in~lation tube 111 is clamped, and the source of i~lation gas is ~ans~erred to the additional inflation tube 115.
The maintainer is then inflated to a fully expanded condition, as shown in figure 5 9C This requires a lpressure in the range S to 10 pounds per square inch (3.5 to 7 k~a), ~ ation of ~he mai~ta~ner 107~ may be beglm before the main inflatable chamber 105 is fully inflated, if desired. An endoscope can be introduced into the m~ i~atable chamber through a gas-tight port 117 on the ~ inflation 10 tube 111 to check the position of the maiIltainer. Xf the maintainer o~structs access to the tissue to be treated, the partially inflated maintainer can be man~pulated to change its position. The maintainer and the main inflatable chamber are then fully inflated.
Once the maintainer 107A is fully inflated, the inflation pressure to the main 15 in~atable c~amber 105 is gradually released. During deflation of the main in~atable chamber, the struciural integrity of the maintainer is observed to ensure that the ma~iner retains the retracted organ in its retracted condition.
Manipula~don of the maintainer may be necessary to ensure that the organ remai~ ades~uately retracted. `
20 ~De~ating tbe m~ inflata~le chamber l~S detaches it from the maintainer lQ7~ Once the main ~i~fla~able chamber is iully defl~ted, as shown in figure 9D,it is evacuated to coll~pse it,~ and ~he inflatable retractor is removed ~om inside the mai~tainer~ a~d rem~ved from the body, leaving the maintainer alorle to keepthe bowel retracted ~d the liYer lifted, as sho~ in figure 9~.
The ~ue~ is ~then treated usi~g inst~uments passe~ into the body through suitable~ineisions`i~ the body wall B~` T~e~ instrun~ents ~arèipasséd through ~he large windows between-the in~atable ~ubçs 113 of the maintainer. The maintainer has no external envelope, so no time need be spent cut~ing ~pertures to gain access to-~the tissue to be treated.-~ ~

30: (c) Type I~A lnflat e Retra~tion Device with Internal Infl~able Main~ainer - The Type IVA in~atable ~e~rac;t;on de~ice may also be packaged with an in~atable mai tainer 107B inside ~ie main inflatable chamber 105. An internal maintainer eliminates the risk of the main inflatable chamber 105 escaping from inside the maintainer 107B during in~lation of the main inflatable chamber.

WO 92/2l2g2 ~ r ! ~ i. ~ i r~r/uss2/o4393 210971~ 26 ``;
Althougli, the maintainer cannot escape l~om the main inflatable chamber, it is still desiraWe to attach the maintainer to the iinside of the main envelope 109.In~ating the main inflatable chamber partially e~ands the ma~ntai~er 107B beforeit is inflated, whic~ malces it easier to in~ate the ma~ntainer. The inflatable S retraction device, with the ~ inflatable cbamber in its i~flated condition, is shown in figure 8C.
f~he internal maintainer variation of the ~pe IVA inflatable retraction device is deployed by the same method as the external ma~ntain,er variation described above. However, after in~a~ion pressure has been removed ~om the main 10 in~atable chamber 105, the main envelope 109 cannot simply be withdrawn from the outside of the maintainer. Instead, it m~st be cut up and removed.
Alternatively and preferably, it is left in place during treatment, and apertures are cut in the main envelope througb which treatment can be carried out. Leaving the main envelope in place enables the tissue to be pulled through the aper~re 15 in the mai~ e~velope and treated inside the main env~lope. The aperture in the main e~velope fonns a seal around the tissue being treated, and blood, debris, etc. a~e retained inside the main enYelope, whence they can easily be removed.

(d) Type fVA: lnf~atable Retraction De~ice with Me~hanical Ma*~ ner The~inflatable maintai~ler 107A of a Ij~ IVA i~flatable retractioll device can 20~ ~ be replaced by a mechanical maintainer ha~nng a bistable folding ri~ structure of metal, plastic, or some~other sl~itable material. Inflating the main in~atable chamber retrac~s tbe organ,~and also partially unfolds the ribs of the maintainer 3 ~ i~to ~ e~anded colldition as the~main i~flatable chamber expands. ~flating the atable:-chamber further fully e?~pands the maintainer by dnving its ribs illtO; ~s~abie,~ ~ver-center ,condi~ion.~ When tbe~ ation pressure in the main 3i . . iIlflaitable ~ChaIIlber iS reduced,~ the ribs stay i n their over-center co~dition. I~ this .. . ~). i . . ., I , i conditi~,~the maintainer has structurai integrity and can maintain the organ retracted by the~;main i~flatable chamber~ its retracted condition.
The mechani~ maintainer of a Type ~IVA inflatable retraction device is 30~ ~removed at ~e end~ of, ~the treatment~by~ dismantling it or cutting it up.
Al~tively, an infl e retractor can once more be placed inside the maintainer a~d in~ated to return the ribs *om their over-center condition. The in1atable retractor is then deflated, which enaWes the maintainer to collapse into `

WO 92~1292 - 2 i O 9 7 1 ~ PCr/U~92/~43g3 its folded conditionO The maiIltainer is then removed in its folded condition along with t~e in1atable retractor.

(e) Type I~ ~nfla~able ~traction Device The Type IVB in~atable retraction device uses the simple mech~cal S maintainer shown in ~gure 1~ e ~tainer 107C compr~ses a first hub 133 and a second hub 135 i~ter~ ected by a plurality of strips or wir~s 131 of a malleable metal or plastic. Alum~Ilum or steel is preferred. Alternatively, the maintainer can be made by maldng a number of longitudinal cuts almost ~om end-to-end of a tube of a suitable malleable ma~er~al. The outs~de diameter of 10 the ~ner 107C is about 11 mm, which enables it ~o pass easily through a 12 mm introducer sleeve.
I~ figure 10B, the main inflatable chamber 105 of the inflatable retractor 103 is pr~ferably a balloon enclosed by a main e~velope 109 of a sui~able elastomeric material such as latex or silicone rubber. The size and s~ape of the main 15 in~atable chamber 105 depe~ds on the application. Using an elastomelic material for the main enYelope enables an envelope of the required strength and in~ated si~e to fit within t~e m~er 107~. The main inflatable chamber is in~ated by a~ ation gas passed through the main in1ation tube 111. - ~
- i i Before ~nsertion into the body, the retractor 103 is assembled with the 20 maintainer 107C, as shown in figure 10(:. :The main inflation tube 111 is temporanly attached to the maintainer to make a single unit for iDsertion.
After the in~atable retraction: device 101 is inserted into ~he body, the main i~atable chamber 105 is iD~a~ed by passing an in~atio~ ~luid through the ation tube 111. . The main in~atable chamber expands radially, which retracts be orga~, and displa~; the stri~ 131 of the maiIltainer radially ouh~ds. ~This - ~ reduces the overall length ;of tbe maintainer. Figure 1ûD ~shows- the shape of the maintainer in i~s expanded co~dition at the end of the ~ation prooess.
fter the mai~ atable chamber 105 is fully inflated, and the-maiDtainer is ~ in ~ e~anded co~ditio~ as shown ~n figllre i10D, the inflation pressure in the30 main in~atable chamber is released~ and the main inflata~le chamber returns to i~s collapsed condi~ion. ~ l~e maintainer 107C in i~s exp~ded co~dition is sufficierltly stro~g to m~ in the organ in its retracted condition. The main in~ation ~ube 111 is then detached from the maintainer, and ~he retractor 103 iswithdrawn from the body. The tissue is treated by instruments passing ~om WIIE) 92/212g2 `' f' ~ ,''<~ " Pcr~u592/o4393 2~0g71~ ' 28 outside the body through the spaces be~veen the strips ~31 of the maintainer 107(:.
Altet~atively, ~he main i~atable c~ambet 105 can be released from the end of tbe main i~ation ~ube 111 and removed from the body. Tbe main inflation S tube is then used as a duct through which to pass instruments from outside tbebody to treat ~he tissue. The instruments pass from outside the body into the interior of t~e maL~tainer, and then pass ~rou~h the sp~ces between the strips 131 of t~e ~tai~er 1~7C to treat the t~ssue.

3. HIGH-STREN~ NPLATING M~THOD
10 A method ~ccording to the ~hird aspect of the invention ~or i~ating Type I, Type III, and Type IV inflatable retraction devices having a second or additional in~atable chamber (an "additional inflatable chamber") enables the collapsed bulk o such in~atable retraction devices to be reduced. The additional i~atable chamber of a~y of ~he above-mentioned inflata~le retraction devices relies on the 15 rigidi~ of its envelope under in~ation pressure for its strength. To pro~de the strength req~ed, the additio~ inflatable chamber must ha~e a rela~ively large ~oss sec~onal area aIld use a relatively high in~lation pressu~e (abou~ te~ times that used iIa ~e main in~atable cbamber). . This in tur~ requires t:hat the . ellvelope o~ the~additional ~atable chamber bcirelatively thi~k. The large area 20 L ~of ~elatively thick material required for tbe envelope of the additional in~atable chamber c~n~butes si~cantly ~o the collapsed bulk of t~e inflatable retraction device.
The~method accordi~g to ~he inve~on of filling the additioIlal in~atable ., . chamber of a~ ir~atable re~raction device fills: ~he additio~al inflatable ~hamber -. 25 . .un~h, a~ ~id .that, oIlce .in place, is made rigid~ -This enables the whole c~oss , . .., ., ... ~ .. .
~ectio~;area of the additional i~ata~le cbamber ~o ~ontribute ~o the strengtb og the add;~onal~ atabie chamber. ~or a ~ven strength, ~e cross-sectio~al area of the additional in~a~able chamber ca~ be:reduced, and lower pressures can~ be used, wbich enables: a s~aller area of a thinner material to be used for dle 30 . e~volope~ of the additional i~atable ~h~2ber. This results in a useful reduction in.:~he ¢~llapscd bulk o~ the additional i~atable chamber, and hence in the coll~psed buL~c of the in~atable retraction device as a whole.
In i~latable retra~ion devices in which the envelope of the main inflatable chamber forms part d the envelope of the addi~ional ir~latable chamber, a i , . ... ..... .. .... ,, ~ .. , ., ~ ~ .. .. ... ..... ...... .... . . . .

W~ g2/21292 ~ 1 ~ 9 7 ~ 4 Pcr/usg2/o4393 ~9 `
thinner material may also be uscd for the envelope of the main i~atable chamber, giving a fur~er reduction in the coll~psed bulk of ~}le inflatable re~action device.
In t~e method according to ~e invention, t~e main ~amber of the in~atable S retraction device is inflated iJI the normal way. The additional in~atable chamber is then filled with a slurIy of a non-soluble particulate solid in a fluid. Preferably7 ~he slurTy is a slurry of glass beads ~n water. Beads in the range 0.040" to 0.080"
(1 to 2 mm) in diameter are prefe~Ted. Alternatively, t~e beads ca~ be of a suitable plastic, such as polycarbonate or acrylic. The additional inflatable 10 chamber is preferably filled by evacuating it, and then pumpin~ the slu~ry in to fill it.
The ~luid is remo~ed from the additional inflatable ~hamber, leaving the parti~ulate solid behind. This is preferably done by inserting intv the in~ationtube a filter ~th a mesh small enough t~ trap the pa~ticulate solid while allouing 15 tbe fluid to pass. The fluid is then pumped out through the filter. The particulate solid is then compacted by evacuating the additional in~atable chamber, With ~e additional cha~nber evacuated, ambient air pressure a~ng ag~inst tbe envelope of t~e additioDal in~atable ch~ber pushes the pa~cula~e solid ~together7- and expels ~luid f~om beh~een the particles of the- solid. This 20 greatly increases ~the ~iCtiOIl between the panicles and allows the ~particles to bind together~to fo~n a pseudo-solid structure.
Trea~ment is carried out working through the inflatable retraction device as /
~o~ When treatment is complete, the ~acwm is released, and fluid is pumped back ~to the additio~al chamber once more to wash ~he parti~ulate solid 25~ out~ o f the addi~donal: i~aubIe ch~er and to allow the~ atable retraction ~; .. device to.be removed:~om the lbody. s The method according to the~ ventio3l is illustrated in fîgures 11A thr~ugh iiC, whi~ show~a~polyhedral Type I~ inflatable retraction de~ice 301, ~he main atable~l~hamber 303 is inflated with a suit~ble inflation gas passed through the30: ~ i~ation tube 305 .iD th~: normal way. ~The additional i~ation hlbe 307 for fîlling the additional intlatable chamber 309 is connected to the sl~ y filling : apparatus 311.
-l~he sluny filling apparatus comprises a reservoir R for the slurry S. The 3l S~ Iy S comprises particles, such as the particle P, of a particulate solid in a 35 liquid L. The reselvoir R has a slurry outlet that is connected to the forward s ~WO 92/212~2 ~ Pcrius9z/o4393 210~714 30 inlet of the reversible pump P. The forward outlet of the reversible pump P iscomlected tbrough the switchable filter F to the first port of the 2-way valve V.
The second port of the 2-way valve V is connected to a vacuum line VAC. ~he ~ommo~ port of the 2-way valve V is connected to the second inflation tube 307.
S The 2~way valve V is set to connect its first port to the common port and the ~ïlter F is set to its off posihan~ The pump P is operated in its fon~ard direction to pump the slurly S inta the addi~ional in~latable chamber 309. T~e in~atable retraction device 301 with its main i~atable ~tamber 303 inflated w~th inflationgas atld its additional in~atable chamber filled witb slurly S is shown in ~tgure 10 llA. Tbe slurIy S in the additional inflatable chamber comprises particles, such as the particle P', of a particulate solid ilt the liquid L.
The filter F is then switched to its on position and the pump P is reversed.
The pump P pumps the slur~ S out of the additional inflatable chamber 309, but the filter F traps the particles of the particulate solid component of the slurly 15 rema~n inside the additional in~atable chamber, and only ~e liquid component L of the slurIy S is retu~ned to the reservoir R The inflatable retraction dev~ce 301 with its main inflatable chamber 303 inflated with inflation gas and its additional in~atable chamber filled with particles, such as the pa~ticle P', of tbe par~culate solid compo~ent of the slu~y is show~ iD ~gure 11B.
20 I~e 2-way valve V is then set to con~ect its secon~ pori to its common port.
~ c~nnects the~ vacuum line VA(: to the additional i~l~tion~ tube 307. The vacuum ~e YAC reduces the ~ressure inside ~he additional chamber 309.
~xte~nal pressure olI the: eIlvelope of ~e additional chamber forces the envelope imvards aIId conso~dates the particles of the p~culate solid. ~ la~ion pressure the ~in~ atable chamber 303 is the~ reieased ;Figure 11C shows the in~ata~le re~action denee 301 af~er the~ addi~ional`iIIfla~able~ chamber 309 has-been evacuated. T~e particles, such-as the.pa~ticle P, of the par~ ate solid Gomponent of the sluIIy `are compacted and provide ~he additional i~atable ~ber 309 with :conside~ably more strength than if the-additi~nal in~atable - -30 c ~amber-were; ~lled~with an i~ation gas. The main inflatable chamber 303 is in its depressur3zed state and an aperhlre 313 has b~en cut in the énvelope of the main in~a~able chamber to provide access to the organ to be treated.
The-2-way valve V and the vacuum line VA~ can be dispensed with if lthe pump P is capable of plllling a vacuum of more than x mm of mercury (kPa~.
35 Tbe pump P is the left running after all the liquid has been removed from ~he Wo 92~21292 ~ 2 1 0 9 7 1 ~ Pcr/VS~2/o4393 additional inflatable chamber 309 ~o reduce the pressure in the additional inflatable ch~nber and consolidate the pa~ticulate solid.
With relatively small retraction devices, a large syringe can be used for the pump P and the re~ervoir R. The same or a different s3ringe cam also be used 5 to evacuate the additional ~f~atable chamber.
Particulate solids other than glass beads can be compacted by heating them or cooling ~lhem. Moreover, ~vith such particulate solids7 it may not be necessaly to remove the liquid compo~ent of the slur~r before oompacting takes place.
Figure 11D shows t~e ~pe IA in~atable retraction device 321, w~ich includes the 10 inner pipe 309 nmning through the additional int~atable chamber 309. Once t~eadditional inflatable cbamber has been f;lled with the slur~y, and the liquid componen~ of the slurry removed, if necessary, a fluid at a suitable temperatureis circulated ~hrough the inner pipe inlet 317~ an inner pipe outlet (not shown), and lhe inner pipe 315. The temperature chan~ caused by the fluid circulating 15 in the inner pipe 315 consolidates the matter ~llling the additional i~atablechamber. If the particulate solid is consolidated by heatillg, a suitable electrical hea~ng eleme~ ~ be substituted for the inner pipe 315.

4. SEL~ RE~ACrlNa ENDOSCOPE ~ ~
.. DuIing endosoopic observation vvi~n tbe body, it is often impossible to see~0 a u~de eIl~ugh area at one ~ime because other organs or tissues obstruct the field of view of the endoscope. Retrac~io~ devices of the type descnbed in ~his application, i~ the prior applica on, alld elsewhere can be used to provide ret~action aIld obtai~ an unobstructed ~iew. The process of correctly positioning ~., . the,retr~ctioll de~ice,~ deploying it, opening up o~e or more observation windows, d remo~g the ~ret~act;on device~ er the obser~tions a~e -complete is ; . ~$ ~ i cumbe~some. ~ A self-re~ng endoscope according -to the fourth aspect of the illveDtion p~o~ides 1QCa1 retraction in the vicinity ~ the distal end of the e~dosc~pe to provide an uIIobstructed wide: field. ~ view.

. (a) Inflat~ble Self-Retraaing Endoscope 30 AI1 inflat~ble self-retraction endoscope 201 according to the invention is shown ill ~gllNS 12A through 12D. The self retracting endoscope 201 c~mprises a subs~tially tubular optical assembly 203 and an inflatable retraction device 205.

WO g2/21292 ;. ~ ^ Pcr/us92/o4393 210971~ 32 l~e optical a~sembly 203 can be the same as ~he optical assembly used in k~own optical or video endos~ope.
The inflatable retraction device 205 is attached to the outer su~face 207 of theoptical assembly 203, close to the distal end of the optical assembly. The S inflatable retraction device 2~5 is provided unth an inflatio~ tube 209 thrQugh which it is in~ted ~nto t~e expanded condition s~own in figure 12A, once inside the body.
The i;nflatable retraction de~ce, when inl1ated, is shaped like a hollow frustumof a cone ha~g its narrow end towards the optical assembly 203. The shape of 10 the in~atable retraction device 205 is designed such that it does not obstruct the peripheral view ~om the optical assembly 203 when the optical assembly is set to its widest ~iewing angle.
In the preferred embodiment, the inilatable retraction device 205 comprises a stack of toroidal balloons 211 made of a suitable elastomeric or non-elastomeric 15 fle~ble material. The diameter of the toroidal balloons inc~eases in ~e distal direc~ion to prevent the inflatable retraction denee from redu~ng the ~eld of view of ~he optical assembly 203.
Alternatively, the version of the in~atable retraction device 205 sho~;vn in iigure 12B can be ~de ~om two sect~r-shaped pieces of an inelastic fle~ble 20 material 213 and 215, respe~ ~ely. Opposing straight sides of each piece of material are co~ected together to form a tru~ncat~d c~ne. The truncated cone ~ormed ~om m~teri~l 213 is placed over the truncated cone made from the material 215, and t~e culved sides of the truIlcated colles are joined together.l'he slanting sides of t}le truncated cones are also tacked together vnth the tacks 217 to give .~he resulting: bollow ~ustum substantially par~llel im~ér and outer : -The self-retracling endoscope 201 is supplied ~th the~inflatable retra~ion device pacl~ed i~ a~collapsed coIIdition 219 flat against ~e ~uter s~rface 207 of the ~ptical assembly ~203,~ showll in figure 12C - An alternative CODStru~ion of30 the self-retracting endoscope 201 for use in an insu~lated body cavi~ is sh~min f;gure 12D. The op~:cal assembly 203 includes a waisted~po~io~ 221 ~hat acco odates the in~atable :retractio~ device in its collapsed state 219 within the overall diameter of the optical assembly. ~he optical ~isembly 203 also accommodates ~e i~ation tube 209 internally so that the self-re~racting WO 92/21292 ` 2 1 0 9 7 1 4 Pcr/uss2/o~393 endoscope 201 has a subs~tially ~stant ci~ cross-section that carl form a seal with the gas-tight port of a troca~ tube.

(b) Methad ~f Using the Setf-Retracting Endosc~pe The method according to the inve~ion of usillg the self-retr~ endoscope

5 201 according to the iI~vention ~o malce observations within a body cavit~ is illustrated in figure 12E, in whic~ the endo~cope is used to observe the gall bladder. An incision I is made in the abdominal wall BW. A trocar tube T is inserted alld the abdomen ~s insuf~ated us~ng known techniques to provide working space. The self-retrac~ing endoscope 201 is inserted into the a~domen 10 through the gas-tig~t port P on the trocar tube T and is advanced past the bowel B a~d under the liver L into the vicini~ of the gall bladder GB.
With a conventional endoscope, pa}t of the gall bladder can be observed~ but attempts to see the gall bladder as a whole are thwarted by tbe liver L. When the collventional endoscope is drawn away from the gall bladder GB to obtain a 15 view of ~e gall bladder as a whole, the liver drops back into place and obstructs the view.
In the method according to the invention of using the self-re~raeting endoso~pe . 201 accor~g to tho inYention, the distal tip of ~he endosc~pe is placed close to the sur~ace ~ the gall: bladder GB, and a source of inflation gas (n~t shown) is;: 20 attached to the in~ation tube 209. The inflation gas pressure is graduallyincreased to e~ d the inflatable retraction device 205. As the in~atable r~raction device 2a5 ~xpands, it pushes ~e distal tip of the endoscope away ~om the gall Wadder, enlarging: the field of ~îew, and retracting the liver to pr&vent the liver ~ obs~ructing the~ view o~ the gall bladder.
ter ~e-obse~vations have beell made,-the in~ation pressure i~ t~e in~atable ~-; retraction device:205 is released to co}lapse ~he inflatable retraction device. The . . - iD~atable retraction device is then evacuated to retract it ~ully. The distal tip the self-re1:racting endoscope 201 can then :be m~ved ~o a difere~t obser~ation- ~ site (if accessible~ f~om the: incision I) and the inflatioll~observation deflation -- 30 ~ seque~ce is repea~ed. In some sircumstances, it may not be llecesary tv dei~e the inflatable retractioll device to change the obse vation site.

W092/2~292 ~ ,f,~ ~3 f, ~ P~/US~2/~04393 21097i4 34 (c) Self-Retr~ng Endoscope with A~ecf~ucal Retr~tor A self-retracting endoscope with a mechanical retractor according to the fourth aspect of the invention is shown in figures 12F and lZG. The self-retracting endoscope 201 comprises a substantially tubular optical assemb~y 203 and an S expandable mechaI~ical retractor 223. The optical assembly 203 can be the same as the optical assembly u~ed in Icnown optical or video endoscopes.
T~ffffffe expandable mechani~ retractofr 223 c,omprises a fixed hub 225 fand a slidable hub Z,27. The ~xed hub 2~f and the slidable hub æ7 are interconneffctedby a plurali~ of sprirfffffgy metf~l or plastic strips or ~nres 229. In the preferred embodiment, optical quality transparent strips are used. The fixed hub æs is affixed to the extension 231 on the distal end of the optical assembly 203. The extension 231 can be a plurality of thin, stiff wires, or can be a hollow ~ylinder of a transpa~ent plastic. The expandable mechanical retractor is expanded by slidiDg the slidable hub ~27 axially along the outer surface 207 of the optical assembly by a suitable mechanism (not shown). The mechanism allows the 3 slidable hub to be locked in position to keep it in its expanded condition. In its expanded condition, the ~ expandable mechanical retractor . retracts organs ~ ~ ob:tructing the field of view from the distal end of the optical assembly.
., ... ,. ~;~gure 12F:~:shows:.:the, expandable~ mechanical retractor in its collapsed 20, condition with:the:strips:.229 of:the retractor lying subst~ntially parallel to Sthe outer su~rface 207.~ of ~,the ~optical assembly. l~e self-retracting endoscope is inserted ~into the body~ in this. state. ~ Figure 12G shows the expandable mechanical retractor~ffl~ its~ Qded condition. The slidable hub 227 has been slid in : : : the distal dir:ction:~ially::alon~the outer surface 207 of the opStical assembly 25 203 ;and hàs been:,.locked~ place. ~ This causes the strips 229 to move radially outwards~ ,to -fo~ ,fthe~ structure ~shown~ .igure .12G, ?which retracts organs or , ,, tissues~,~hat, would,:.otherwise ~obstruct~ the ,view from the optical assembly.
Observaeions are carried.:out loold~g though tbe strips ;æs and the exte~ion 231.
. ., After~observa~ions,~.havé~beèn~ completed, the slidable hub 227 is slid pro~mally .30.,.~- along the outer surface~,207~of the op~ical assembly to returli the expandable . . . ret~or to its:::collapsed condition so: that the self-re~acting endoscope can be wi~d~wn; from ~thè~ body~

? ~ ~
~: : :::
::

Wo s2t21292 2 10 9 7 1 4 ~ ~ ~ pcl/uss2/o4393 5. INSERTION TusE
In~atable retraction devices in their collapsed state have conventionally been paclced in a substantially cylindrical package for insertion into the body prior to deployment. The c3~1indrical package has corlventionally been introduced into the S body by pushing it ~rough a suitably-sized trocar tube or introducer sleeve. If the outside diameter of the package ~as been close to the diameter of the diameter of the bore of the trocar tube, there is a tendency for tbe package to stick in the bore of the trocar tube. Pushing the package harder causes the package to buckle, and wedges the package more firmly. An inseItion tube 10 according to a ~fth aspect of the invention draws the packaged ~etraction device into the body and a~oids problems with the package sticldng.

(a) lnser~ion tubes -The most basic fo~m of the insertion tube 241 according to the fifth aspect of the invention is shown in figure 13A. The msertion tube 241 comprises a tube 15 243 aIld a string 249 having a firse end 2Sl~ and a second end 253. The first end 251 of the stnng passes distally outside the tube 243. At the distal eIId 244 ofthe tube, th~ first end of the string passes into the bore 247 of the tube, passes proximally ~rough~the bore, and emerges &om the proximal end 246 of the tube.
;- ~iThe;~first end 251~ of the string is attacbed to -~he pro~mal end 255 of the 20 packaged inflatable retraction device 257. To reduce friction be~Areen the string 249 and the distal end 2~4 of the tNbe, the ~ube 243 should have a relatively ~ick: wall, and ~the~ distal end ~44 should be ~;rounded. A radial g~oove can bemade in the~distal~end to locate the s~ring, if desired.
A less basic foIm of the insertion tube 241; according to the fifth aspect of the " ;~ 25 ~ entio~ is shown in~f;gure 13B.; The ~nsertion tube~241 comprises- a tube 243 ha~ng !a ismall ey~iet 245 ;attached to ;ts dist~l end 244. `-The insertion tube 241 also comprises a string 249 hàving a ~st end 251 and a second end 253. The ~t end 251 vf ~the string~ passes ~dist~lly~through the bore 247 of the tube~
thrQugh the eyelet 245, passes pro~imally back through the bore, and emerges 30 ~ from the~ pro~m~ end 246 ~of ~the tub~. The first end 251 of the string is attached to the prox~mal end 255 of the packaged inflatable ~etraction device 257.
An irllproved Ya~iation of the insertion tube 241 according to the illvention isshown in figure 13C In the improved variation, the string is contained within the ins~rtion tube, unlike the version shown in figure 13A, and the bore 247 of ~he WO 92~21292 2 1 0 9 7 ~ Pcr/US~2/o4393 tube 243 lacks the eyelet 245 ~at could snag the packaged ir~atable retraction device 257 in the version shown in figure ~3B. ~e improved version of the insertion tube 241 has a narrow-bore tube 255 attached to the outer wall 257 of the tube 243. 'rhe distal end of the narrow-bore tube extends slightly beyond the S dis~al end of the tube 243 to aid in ejecting the packaged in~atable retraction device 257 from the bore 247. To give the iDsertion tube a smooth outer wall, ~he tube 243 and the narrow-bore tube 255 are enclosed in an outer tube 259.
ll~e nalTow-bore tube 255 can also be attached to the bore 247 of the tubs, as shown ~ ffgure 13D~ This eliminates the need for the outer tube 2~9.
10 In the versions of the insertion tube shown in figures 13C a~d 13D, the firstend 251 of the stling 249 passes distally through the bore of the narrow-lbore tube 255. At the distal end of the nalT~w-bore tube, the first end of the string enters the bore 247 of the ~ube 243, passes proximally through the bore 247, and emerges from the pro~al end 246 of the tube. The first end 251 of the st~ing 15 is attached to the pro~al end 255 of the packaged inflatable retra~ion device.

(b)Method of Usutg an lnsertion Tube The methcd accord~ng to ~he invention of placing a substantially ~ylind~ical pac~age, fo~ oxample, an paclcaged in~atable retraction device, into the body using . an inso~on tube accordirlg to the invention is as follows. The distal end of tbe 20 inser~on tube is inserted into the body by inserting ;t into a trocar tube in place in the body. If ~e body is insuf~ated, the insertion tube ;s passed through a gas-tight port on the t~ocar tube, and is fitted unth a gas-tight port itself. The insertio~ tube is mani~ulated to bring its distal end close to ~he poin~ at which it is desired to deposit the i~1a~able re*action device. The ~rst end 251 ~f thec ~ 25 striDg is attached :to the ~pr ximal end 255 of the packaged in~latable re~action device. T~e ~ end of ~e packaged inflatable retraction device is inserted into the pro~dmal end of the~ bore ~47 of dle tube, and the packaged iD~atable retrac~o~ device is pushed into the bore of the tube as far as it will go.
- The inser~ion tllbe 241 is ~en grasped with one haIld a~d the second e~d 253 30 of the string is gras~ed ~nth the other. The second end o~ the string is thenpulled pr~ lly to draw the packaged inflatable retraction de~ce through the bore 247 of the tube. Becau~e ~e first end 251 of the s~ring is attached to the pr~ximal end 255 of the packaged retraction device, a final pull orl the second elld 253 of the string ejects the packaged in~atable retraction device frvm the WO g2/Z11292 q ~ r v ~ ~ t,"~. ,, "" ~ 9 71 ~L PCr/lJS92/04393 ; 37 bore of the tube. The insertion tube 241 is then withdrawn irom the trocar tulbe, and the in~atable retra~ion deYice is released from its packag~g. This also de~aches the str~ng 249 ~om the infla~able re~raction dev~ce. The string 249 a:~d the packaging ar~ withdrawn ~om the body ~hrough tbe trocar tube. The 5 inflatable ret~action device is then depl~yed in the normal way.

.
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Claims (69)

Claims We claim:

1. Apparatus (1) for retracting an organ (e.g., L) inside the body to gain access to an adjacent tissue (e.g., GB), the apparatus comprising:
a first inflatable means (5) for retracting the organ when the first inflatable means is inflated to an expanded condition, the first inflatable means having a first envelope (3), and means (7) for selectively inflating the first inflatable means into an expanded condition when in place in the body; characterized by:
a non-pressurized chamber (13) inside the first inflatable means, the non-pressurized chamber having a second envelope (11), part of the second envelope being attached to part of the envelope and providing a treatment window (6);
a second inflatable means (25), operably associated with the non-pressurized chamber, for expanding the non-pressurized chamber into an expanded condition when the second inflatable means is inflated;
means (35) for selectably inflating the second inflatable means; and means (31) for providing a substantially gas-tight passage for an instrument to pass into the non-pressurized chamber.

2. The apparatus of claim 1, further characterized in that the second inflatable means (25) has a cage structure.

3. The apparatus of claim 1, further characterized in that the second inflatable means includes a toroidal balloon (43).

4. The apparatus of any of claims 1 through 3, further characterized in that the means for providing a substantially gas-tight passage for an object to pass into the non-pressurized chamber comprises a gas-tight port (31) between the first inflatable chamber (3) and the non-pressurized chamber (13).

5. The apparatus of claim 4, further characterized in that:
at least part of the second envelope (11) comprises an elastomeric material (29), and the elastomeric material forms a gas-tight port (31).

6. The apparatus of any of claims 1 through 5, further characterized in that the means for providing a substantially gas-tight passage for an object to pass into the non-pressurized chamber (13) is additionally for maintaining the first inflatable means (3) in its expanded condition by providing:
(a) a substantially gas-tight seal around an object inserted into the gas-tight passage, and (b) a substantially gas-tight seal when the object is not inserted in the gas-tight passage.

7. The apparatus of any of claims 1 through 3, further characterized in that the means for providing a substantially gas-tight passage for an object to pass into the non-pressurized chamber comprises a duct (37) passing through the first inflatable means (5).

8. The apparatus of any of the preceding claims, further characterized in that the first envelope (3) comprises an elastomeric material.

9. The apparatus of any of the preceding claims, further characterized in that:
(a) the non-pressurized chamber (5) is a first non-pressurized chamber, (b) the apparatus further comprises:
(1) an additional non-pressurized chamber; and (2) a third inflatable means, operably associated with the additional non-pressurized chamber, for expanding the additional non-pressurized chamber into an expanded condition when the third inflatable means is inflated; and (c) the means (35) for inflating the second inflatable means (25) is additionally for inflating the third inflatable means, the means for inflating the second inflatable means inflating the second inflatable means or the third inflatable means depending on the positions of the first non-pressurized chamber and the additional non-pressurized chamber relative to the tissue when the first inflatable means (3) is inflated.

10. A method of retracting an organ inside the body to gain access to an adjacent tissue, the method comprising:
(a) providing an inflatable retractor, comprising:
(1) a first inflatable chamber having a first envelope, (2) a non-pressurized chamber inside the first inflatable chamber, the non-pressurized chamber having a second envelope attached to part of the first envelope, and (3) a second inflatable chamber operably associated with the non-pressurized chamber;
(b) placing the inflatable retractor in a collapsed condition adjacent to the tissue;
(c) inflating the first inflatable chamber to retract the organ; and (d) inflating the second inflatable chamber to expand the non-pressurized chamber into an expanded condition

11. The method of claim 10, wherein the step of inflating the second chamber to expand the non-pressurized chamber into an expanded condition comprises:
inflating the non-pressurized chamber into an expanded condition;
inflating the second inflatable chamber into an expanded condition; and deflating the non-pressurized chamber.

12. The method of claim 11, further comprising:
providing a cutting instrument;
providing a substantially gas-tight passage between the first inflatable chamber and the non-pressurized chamber;
passing the cutting instrument to the first inflatable chamber;
passing the cutting instrument through the substantially gas-tight passage into the non-pressurized chamber, the substantially gas-tight passage forming a substantially gas-tight seal with the cutting instrument; and piercing by means of the cutting instrument an aperture in the first envelope to gain access to the tissue.

13. The method of claim 12, further comprising pulling the tissue through the aperture into the non-pressurized chamber.

14. The method of claim 12, further comprising:
providing a surgical instrument; and treating the tissue by passing the surgical instrument through the aperture.

15. The method of claim 10 further comprising pulling the tissue through an aperture in the first envelope into the non-pressurized chamber.

16. The method of claim 10, further comprising:
providing a surgical instrument;
passing the surgical instrument into the non-pressurized chamber; and treating the tissue by passing the surgical instrument from the non-pressurized chamber through an aperture in the first envelope.

17. The method of claim 16, further comprising:
providing a substantially gas-tight port between the first inflatable chamber and the non-pressurized chamber; and wherein the step of passing the surgical instrument into the non-pressurized chamber includes passing the surgical instrument through the substantially gas-tight port.

18. The method of claim 16, further comprising:
providing a duct between the non-pressurized chamber and the first envelope; and wherein the step of passing the surgical instrument into the non-pressurized chamber includes passing the surgical instrument through the duct.

19. The method of claim 10 wherein the non-pressurized chamber includes a duct passing through the first inflatable chamber, and the method further comprises:
providing a cutting instrument;
passing the cutting instrument through the duct into the non-pressurized chamber; and piercing by means of the cutting instrument an aperture in the first envelope to gain access to the tissue.

20. The method of claim 19, further comprising pulling the tissue through the aperture into the non-pressurized chamber.

21. The method of claim 19, further comprising:
providing a surgical instrument; and treating the tissue by passing the surgical instrument through the aperture.

22. The method of claim 10, wherein:
the step of inflating the first inflatable chamber inflates the first inflatablechamber to a pressure in the range of 0.14 to 0.28 kilo-Pascals;
the step of inflating the second inflatable chamber inflates the second inflatable chamber to a pressure in the range of 1.4 to 3.5 kilo-Pascals; and the pressure in the non-pressurized chamber after the step of inflating the second inflatable chamber is substantially equal to atmospheric pressure.

23. A method of retracting an organ inside the body to gain access to an adjacent tissue, the method comprising:
(a) providing an inflatable retractor, comprising:
(1) a first inflatable chamber having a first envelope, (2) a non-pressurized chamber inside the first inflatable chamber, the non-pressurized chamber having a second envelope attached to part of the first envelope, and (3) a second inflatable chamber operably associated with the non-pressurized chamber;
(b) providing an endoscope having a proximal end and a distal end;
(c) securing the table retractor in a collapsed condition to the endoscope adjacent to the distal end of the endoscope;
(d) inserting the distal end of the endoscope together with the inflatable retractor into the body;
(e) inflating the second inflatable chamber to expand the non-pressurized chamber into an at least partially expanded condition;
(f) manipulating the endoscope while observing through the endoscope to locate the non-pressurized chamber adjacent to the tissue; and (g) inflating the first inflatable chamber into a fully-expanded condition to retract the organ.

24. The method of claim 23, wherein the step of securing the inflatable retractor in a collapsed condition to the endoscope adjacent to the distal end of the endoscope includes inserting the distal end of the endoscope into the non-pressurized chamber.

25. The method of claim 23, wherein the step of inflating the second chamber to expand the non-pressurized chamber into an expanded condition comprises:
inflating the non-pressurized chamber into an expanded condition;
inflating the second inflatable chamber into an expanded condition; and deflating the non-pressurized chamber.

26. The method of claim 25, further comprising:
providing a cutting instrument;
providing a substantially gas-tight passage between the first inflatable chamber and the non-pressurized chamber;
passing the cutting instrument into the first inflatable chamber;
passing the cutting instrument through the substantially gas-tight passage into the non-pressurized chamber, the substantially gas-tight passage forming a substantially gas-tight seal with the cutting instrument; and piercing by means of the cutting instrument an aperture in the first envelope to gain access to the tissue.

27. The method of claim 26, further comprising pulling the tissue through the aperture into the non-pressurized chamber.

28. The method of claim 26, further comprising:
providing a surgical; instrument; and treating the tissue by passing the surgical instrument through the aperture.

29. The method of claim 23, further comprising pulling the tissue through an aperture in the first envelope into the non-pressurized chamber.

30. The method of claim 23, further comprising:
providing a surgical instrument;
passing the surgical instrument into the non-pressurized chamber; and treating the tissue by passing the surgical instrument from the non-pressurized chamber through an aperture in the first envelope.

31. The method of claim 30, further comprising:
providing a substantially gas-tight port between the first inflatable chamber and the non-pressurized chamber; and wherein the step of passing the surgical instrument into the non-pressurized chamber includes passing the surgical instrument through the substantially gas-tight port.

32. The method of claim 30, further comprising:
providing a duct between the non-pressurized chamber and the first envelope; and wherein the step of passing the surgical instrument into the non-pressurized chamber includes passing the surgical instrument through the duct.

33. The method of claim 23, wherein the non-pressurized chamber includes a duct passing through the first inflatable chamber, and the method further comprises:
providing a cutting instrument;
passing the cutting instrument through the duct into the non-pressurized chamber; and piercing by means of the cutting instrument an aperture in the first envelope to gain access to the tissue.

34. The method of claim 33, further comprising pulling the tissue through the aperture into the non-pressurized chamber.

35. The method of claim 33, further comprising:
providing a surgical instrument; and treating the tissue by passing the surgical instrument through the aperture.

36. Apparatus (103) for retracting an organ (e.g., L) inside the body to gain access to an adjacent tissue (e.g., GB), the apparatus comprising an expandable cage (107) having an open structure wherethrough an instrument can pass, characterized in that:
the apparatus additionally comprises:
a main inflatable chamber (105) having an envelope (109) of an elastomeric material, and means (111) for selectively inflating the main inflatable chamber when in place within the body to retract the organ into a retracted condition; and the expandable cage is operatively associated with the main inflatable chamber, is expanded, at least partly, by inflating the main inflatable chamber; and maintains the organ in its retracted condition after the main inflatable chamber is deflated.

37. The apparatus of claim 36, further characterized in that the expandable cage comprises an additional inflatable chamber (107A).

38. The apparatus of claim 37, further characterized in that the additional inflatable chamber (107A) is outside the main inflatable chamber (105).

39. The apparatus of claim 38, further characterized in that the additional inflatable chamber (107A) comprises a cage-like structure.

40. The apparatus of claim 37, further characterized in that the additional inflatable chamber (107A) comprises a cage-like structure.

41. The apparatus of claim 36, further characterized in that:
the expandable cage (107C) comprises plural strips (131) of a malleable material arranged to form the curved surface of a cylinder, and the main inflatable chamber (105) is mounted inside the cylindrical cage.

42. The apparatus of claim 36, further characterized in that the expandable cage (107C) comprises:
a first hub (133) and a second hub (135), each hub being cylindrical and having a curved outer surface; and plural of strips (131) of a malleable material, each strip having a first end and a second end, the first end being attached to the curved outer surface of the first hub, and the second end being attached to the curved outer surface of the second hub.

43. The apparatus of claim 36, further characterized in that the expandable cage (107C) comprises a hollow cylinder of a malleable material, the hollow cylinder having a curved sidewall, a first end, and a second end, the curved sidewall being pierced by a plurality of longitudinal cuts extending from a point adjacent to the first end to a point adjacent to the second end to provide plural strips interconnecting the first end and the second end.

44. A method of retracting an organ inside the body to gain access to an adjacent tissue, the method comprising:
(a) providing a main inflatable chamber and maintainer;
(b) assembling the maintainer and the main inflatable chamber;
(c) placing the maintainer and main inflatable chamber assembly in a collapsed condition adjacent to the organ;
(d) inflating the main inflatable chamber to retract the organ into a retracted condition;
(e) expanding the maintainer to maintain the organ in its retracted condition; and (f) deflating the main inflatable chamber.

45. The method of claim 44, further comprising removing the main inflatable chamber from the body.

46. The method of claim 44, wherein the step of assembling the maintainer and the main inflatable chamber includes placing the maintainer inside the main inflatable chamber, and the step of expanding the maintainer to maintain the organ in its retracted condition includes inflating the maintainer.

46a

47. The method of claim 44, wherein the step of assembling the maintainer and the main inflatable chamber includes placing the main inflatable chamber inside the maintainer, and the step of expanding the maintainer to maintain the organ in its retracted condition includes further inflating the main inflatable chamber.

48. The method of claim 44, wherein the step of assembling the maintainer and the main inflatable chamber includes placing the main inflatable chamber inside the maintainer, and the step of expanding the maintainer to maintain the organ in its retracted condition includes inflating the maintainer.

49. A method of inflating an inflatable retraction device, the method comprising:
providing an inflatable retraction device having a main inflatable chamber and an additional inflatable chamber;
providing a slurry of a particulate solid in a liquid;
inflating the main inflatable chamber;
inflating the additional inflatable chamber with the slurry;
removing the liquid from the additional inflatable chamber, leaving the particulate solid behind; and compacting the particulate solid to form a substantially rigid structure.

50. The method of claim 49, wherein the particulate solid has particles of greater than a predetermined size; and the step of removing the liquid from the additional chamber leaving the particulate sold behind includes:
providing a filter having a mesh smaller than the size of the particles of the particulate solid, and pumping the liquid from the additional inflatable chamber through the filter.

51. The method of claim 49, wherein the step of compacting the particulate solid to form a rigid structure includes evacuating the additional inflatable chamber.

52. The method of claim 49, wherein the step of compacting the particulate solid to form a rigid structure includes heating the particulate solid.

53. The method of claim 49, wherein the step of compacting the particulate solid to form a rigid structure includes cooling the particulate solid.

54. Apparatus for observing a tissue inside the body, the apparatus comprising:
optical means for observing the tissue, the optical means having a substantially cylindrical structure, and a distal end that is inserted into the body;
retraction means for retracting an organ adjacent to the tissue that would otherwise obstruct observation of the tissue, the retraction means being attached to the optical means adjacent to the distal end of the optical means, and being in a collapsed condition when the distal end of the optical means is inserted into the body; and means for expanding the retraction means inside the body.

55. The apparatus of claim 54, wherein the retraction means includes an inflatable chamber, and the means for expanding the retraction means inside the body includes means for inflating the inflatable chamber.

56. The apparatus of claim 55, wherein the inflatable chamber has a hollow frustroconical shape, is substantially concentric with the optical means, and has a diameter that increases distally.

57. The apparatus of claim 55, wherein the inflatable chamber comprises a stack of inflatable toroidal balloons having progressively increasing diameters.

58. The apparatus of claim 54, wherein, the retraction means comprises:
a transparent collar attached to the distal end of the optical means, a collar slidably mounted on the optical means, a plurality of elongate flexible members attached to the transparent collar and to the collar, and the means for expanding the retraction means includes means for sliding the collar along the optical means towards the transparent collar.

59. The apparatus of claim 58, wherein the elongate flexible members are strips of a transparent plastic.

60. The apparatus of claim 58, wherein the elongate flexible members are wires.

61. Apparatus for inserting into the body a substantially cylindrical object having a proximal end and a distal end, the apparatus comprising:
an elongate tubular member having a bore, the bore slidably receiving the object and having a proximal end and a distal end;
a string passing from the proximal end to the distal end of the tubular member inside the bore, and returning to the proximal end of the tubular member;
means on the portion of the string passing inside the bore to enable the string to be attached to the proximal end of the object.

62. The apparatus of claim 61, wherein the string returns to the proximal end of the tubular member outside the bore.

63. The apparatus of claim 61, further comprising:
an eyelet at the distal end of the tubular member; and wherein the string passes through the eyelet, and returns to the proximal end of the tubular member through the bore.

64. The apparatus of claim 61, wherein the elongate tubular member is a first elongate tubular member;
the bore of the first elongate tubular member is a first bore;
the apparatus further comprises a second elongate tubular member attached to the first elongate tubular member, the second elongate tubular member having a second bore; and wherein the string returns to the proximal end of the first elongate tubular member through the second bore.

65. The apparatus of claim 64, wherein the second elongate tubular member is inside the first bore.

66. The apparatus of claim 64, wherein the second elongate tubular member is outside the first bore.

67. The apparatus of claim 64, wherein the second elongate tubular member has a distal end, and the distal end of the second elongate tubular member projects beyond the distal end of the first elongate tubular member.

68. A method of inserting into the body a substantially cylindrical object having a proximal and a distal end, the method comprising:
(a) providing an insertion tube comprising:
(1) an elongate tubular member having a distal end and a bore, the bore having a proximal end and a distal end, (2) a string passing from the proximal end to the distal end of the elongate tubular member inside the bore, and returning to the proximal end of the elongate tubular member;
(b) attaching the string passing inside the bore to the proximal end of the object;
(c) inserting the distal end of the object into the proximal end of the bore;
(d) inserting the distal end of the elongate tubular member into the body;
and (e) pulling on the string returning to the proximal end of the elongate tubular member to draw the object through the bore.

69. The method of claim 68, wherein the object is an inflatable retraction device in a collapsed condition, and the inflatable retraction device is for retracting an organ, the step of inserting the distal end of the elongate tubular member into the body includes placing the distal end of the elongate tubular member adjacent to the organ, and the step of pulling the string returning to the proximal end of the elongate tubular member additionally includes ejecting the inflatable retraction device from the bore adjacent to the organ.