CA2110153A1

CA2110153A1 - Endoscopic inflatable retraction devices, methods of using, and a method of making

Info

Publication number: CA2110153A1
Application number: CA002110153A
Authority: CA
Inventors: Frederic H. Moll; Albert K. Chin; Thomas R. Gadacz
Original assignee: Individual
Current assignee: Origin Medsystems LLC
Priority date: 1991-05-29
Filing date: 1992-05-29
Publication date: 1992-12-10
Also published as: US5402772A; EP0586561A1; US5531856A; EP0586555A1; CA2109803C; EP0804902A3; EP0586561B1; AU2145692A; WO1992021295A1; MX9202603A; US5575759A; US5361752A; ES2091476T3; EP0804902A2; US5454367A; ES2115672T3; JPH06507810A; CA2109803A1; DK0586555T3; AU2176892A

Abstract

Inflatable retraction devices for use in laparoscopic surgery are inserted into the body in a collapsed state adjacent to an organ, and are inflated into an expanded state to retract the organ to provide access to treat a tissue. In a first variation, the inflatable retraction device retracts the organ by exerting a force against adjacent organs. In a second variation, the inflatable retraction device retracts the organ by providing a retraction force from outside the body. An inflatable retraction device that provides the retraction force from outside the body can be made using a Foley catheter.

Description

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~` ` 21i~1~3 ` INTE'RNATIO~AI, Al'Pl~ lON U3'~'~D'R 1 : PAl~E~'T CC~OPF~ATIO~ ~E~TY
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APPLICAT101~' FOR PATENT
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ENI~OSC~PIC ~FLAT~LE RE~CI101~ J)EVlCF,S, MET3HODS O~ USl~G, ~ND ~ M131~1OD OF M~KING
i l ~nYcnto~s; Frederic H. Mol~
Albert ~ Chill ~; I'homas R. .Gadac~ -.; .
siField of the InYe~t~on ~The invention rela~es to de~aces ~or use jn laparoscnpic sl~rge~.~" in pærticul~r, 0~to devices t:hat pro nde ~etra~tion l~f an organ to gain acce~s to treat or obserYc a ti~sue.

.. 5 .Background o~ the InYenti~n Laparos~opy dates back to the turn of the 20th Centu~y. EarJy l~paro~copic `'~7~'1 teehniq~es wc~ used primar.ly fi)r diagnostic p~rposcs to ~,iew Ihe in~erndl organs, vi~out thc nec~sity of convenliona3 surgery. Since the 1~30s. lapa~os~opY ha~
. been u~e~ for steriliza~ion arld, more reccnlly, for the suturing of hernias. ~3.S.
10Patents ~,919,1S2 and 4,~44,44~ are ct~ncerned vrith techniques f~r su~rin~, herJua~. Anothcl ~ery rccent inno ation i~ the use of laparoscopic ~urger~ for remo~Dg thc gallhladder.
Published lnternational Application No. WO-~ 92/2~294 under ~h~ Pa;ent Cwpesati~n Treaty, of ~vhich applic~lion the parent of ~his application is a ;~1 15C~on~alion~ Part, dc~crib~s an appsra~us and n~ethod wherein the abdominal wall ~ l~fl~ awa~ from ~he u~derlying abdominal organs by an inflata~le device ~bic~ is introduccd laparocopica3ly and, onse in place, inflaled to engage and !ift nsivç area of thc abdominal wall.
.~, Even when such lifting ~cchniqucs are used, it is ~ill nece~sary to re~ract other 20 orga~s to gun access to thc organ OJ tissue to be ueated or observcd. Jn uther ~ pr~cedures, ta g~in access tO ~hc org~n or ~issue tP be trca~ed or o~ ved, it is i~ necessary to separate th~ organ to be trcated ~orn tissue surrou;ldi~g it. For cxample, to be a~le to obse~ve ~he outer surfac~ th~ he~rt, tbe outer surface of~be heart has IO l~e separ~ted ~om thc pencardium.
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2 1~ 3 ~lblisbed Lnterna~ional ~pplic~tion NQ. WO-A 92/2129~ under the Paten~
Coopcration Trea~ application of w~;ch this 8pplicaticn iS a Continua~i~)n-~! in-Part ~the '~a~ent app!icanon"~, de~ es i~Dat~ble retraction deviccs lhat retr~c~ org~s or tissues ~y means of an inflatable chan-~e~. l'hc resractior.
S deYice ~s illtroduced in ~ collap~ed state into the body throu~h a small incision, ~` and, once in pla~c, inflated ~o en~age an extensive arc~ o~ the organ or tissuc lO
~e retr~t~d, and t~ gently re~ract or displace the organ or lissl~c without ~ama~g it. Ounng pa~oscopic treatment a~d ob~rvatior. prccedure~, ~he rctraction delnce retair~ s expanded condition, aDd hcnce i~ abili~ to pro~idc retraction, whil~ providing acccss ~or surg;cal instrumcnts through itself tc, the organ o~ su~ being treated or observ~d, or allowing an ~rg,an or tissue to be brought inside itself ~or obscrvation or trcatnnellt.
Tbe infla~ble retrac~ion devices described in the parnt applic~ n, and one of thc inflat~ble rctraction deviccs describe,d in the present applicatir~n, are pl~ced ;~ 15 in the body through a small inc-sion, and, ~hen inflated, rct~ the organ by ``~ pushi~g aga~nst other adjacent orgarLs and tissue~. Tl;e forcc exerted by the se~raction de~qc~ again.~t othcr or~ans or tissues w~lhln ~he b(ld~ can t some~imes cause trallrna and eYen damage to the o~her organs. ~ence, it i~
s~mg~es preferable ~ pr~ide a. retraction ~c~ice that CaD intrnduced imt~ the ~ ltody ~hrough a small incision, anul ~hich pro~ides retractil~n with~ut exerting a .~i force aga~nst other adjacent org~n~ and ti~ s.
To pr~de a retr~tio~ from outside thc body, curren~ laparosc~pic prt~cedwes ~-~ u~e se~cs~l ~mall metal or plastic retracls)rs ins~rted ~hough a plur~lity of ;~ inc~sions. TJle retractor~ aJe fixed to a suitablc bar to hold them in place ~)nce the desired amoun~ of retra~ion has been a~ievcd. Bccause iuc}l retractors h~ve a r~lat~ely small su~face area tthc retractors haYe ~o ~e small cnough to fit ~5 thtough a- small incisioD), tbe~ tend ~o damage and/or c~use trauma to tbe j-,' re~actcd ~rgans. ~orco~cr, thc rcquired pluJali~y of inc ~.ions in the body wall :,~ undocE. somc of ~hc advanta~,e o~ using laparo~.copic techniques.
, S~nuy Or the In~tlon .: Thc pre~ent il~vcntion selalcs to inflatablc re1raction dc~icc~ that mechanically rctract srgw and tissucs to pro~nde access t~ trcat or observe other O.g'dllS ortiss~es. In tbe following descnption, ~he wo~d "organ~ ~iU be u~ed to mean an , osgan or a tissue that is rctracled by the retraction dG-.rice The word "~reat" will LI~CH a Ll~1BP,CH S,F, TO. ~"9 691~3.~9C~ Ll`l~.~CH s -- +4u 2113~53 be ~se~ ~ mean bo~h treat and o~er~e, and thc word "trça~mcnt" ~11 be uscd to ~nean bolh treatmcnt and o!oserv~tion. ~nc word "tissue" or the phsase "tissue ~o bc ~eated" will both ~c used to m~an ~he ~r~an or the lissue that is lr~ated a~er the organ has been retracted.
.~ 5 ~n inflatable retraclion device according t~ a firsl aspect oi the invention is used in th~ body ts) retrac~. a first organ fr~n a seco~d organ lo gain a~ess lOa t~ssuc adjace~ to the ~Irst orgaJl~ Thc inflatable retracnon de~nce comprise~ ~n ~ ~nflatable chamber for app3ying a I~rce be~wcen the first o~gan and ~hc second '~ to retrac~ thc first osgan from the secnnd organ. The ir~tab~e charnher is 3'' 1~ ~daptcd ~or insertion in a collapscd s~ate ~nto tbe b~y Ihr~ugh a lapar~copic incision, and has a thin, fl~uble cn-elopc. ThG apparatus al~o includcs a de~qcef~r ~elcctivcly i~flaung the in~latab3e chambcr to an ~xpar.~led ~tate while th~ir~latable chambet is in place withir, the. bod~.
~! ~e infla~able retrachon device i~ used ir~ appIicati~ns in wh;ch it can be plac~d so that i~ r~rac~s the organ w~itht)ut obstructing acces~ ~ thc tiss~le being trcatcd. Treatment of the tissuc is carned .l ut wor3dn~ around the retr~ctioll ., .
deYice. Surgical instruments a~e passed inlo the body through a ~i~cond sm~
inci~ion, a~d pass sround the oulsi~Je o~ the retraction device to reach t~le tissue.
In a first method accord;ng ~o th~ inven~i~n of using an in~latablc retraction de~n~e to ~tract a ~Irst ~rgan from a ~ccond organ in the b~dy in the cour~c )f,3 ~reating a ~issue adjacent t~ the first organ, an inflatable retr~clion device i~
ha~ing a coll~psed state arld an exl)andcd state is p-ovid~d. A small incisiot i~
rna~ in tbe body and ~he inllatabie r~tractioIl dev~ce in ~hc collapsed s~a~e is~ntroduccd into the body through the m~ ncision. The ir~la~able re~ inn 2S devicc ~n thc ~Da~sed state is placed ~ cn~een the first org~n and lhe sec~nd org~ a~d is i~ ted int~) the expanded state l~ apply a forcc belwcen the ~rst ~; or~ and the scc~nd organ to Ictract the ~Irst org~n fr~m thc second organ.
A~ atable Jetrac~o~ deYicc accoJding to a second a~pect of ~be invcntjon pJoYides a ~e~racti~n force fron uu~side the body tO retract ~n ~rgan irLside the ~ 3~ body ~o ga;n access to ~n adjacent tissue. Tbe infla~ahle rctraction ~e~icc .j ~mpnses an inflata~lc cbamber that enga~es w~sh the organ, and a shah ~or manipulati~g the inflatabJc cbamher ~o JC~aC~ tbe organ. l hc sb~ft has a distalcnd ~o which thc in~latable chamb~ is attached, a bore that communica~es ~nth ~, the in~atable cham~çr and allows thc inna~able chamber to be infla~cd to an j1 ~5 exp~ldcd state vvhcn thc in11atable chamber is in p!~c~ ithin the body. llle ,,, ~

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~;1 In z first variation, the iDflat~blc chamber is ~ubs~antially sphe~cal; in ase~ond var~ation, the inflatable chamb~s is nat, and substa~ttiall~ o~lvng; and ~n i~ 5 a ebird ~ariation, ~hei i~latablc retraaion dcvioe eomprises ~ balloon cat~eter with .~ a stylet inscrted into the tube of the balloon cathcter.

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211 ~ 3 ! 4 In a sec~d mcthod according to ~he invention ~r ret~ctin~, by mean~ of a `. retrastion force provided frcm outsidc thc body, an orga~ in the ~ody in 1he collrse of tre~ting as~ adjac~nt t.ssue, an in~latable r~tract~r is provided ha~1in~ ~n 1 inflatable cha~ber, an~ a hollow shaft haYing a distal end and a proximal end.
s S The inflatable chsmber is anaehed to thc distal end of the shaf~ in a collapscà
.; state. A un~ll indsion is madc in t~. boBy~ 'rhe proximal end of thc shaft is J manipuiated to pa~s the infl~atab3c chambçr and pan of ~he shaft into the body ~:! ~ou~ le ~mall i~cisio~, and ~o p~ace thc inflatahlc ch~mber ad~acen~ ~o the organ. A fluid is passed th~ough the sh~t to inflate the ~nnatable chambcr ;n~o 0 an cxpandcd s~ste~ Finally, the proximal end of the shah is m~nipula~ed toengage thc or~an with the inflata~le ch~mbcr, and to retr~ct the nrg~n~
In a method Iccord~ng to t~e ir~venti~n of makiD~ an inflatab~e retrac~ n ~' deYice, a balloon cathe~er ha~ing an inflatablc cb~mber and a flexihlc tu~e is provided. A rigid s:ylct is also prl)vid~d, and is inscrted in~o the flexiblc tuhc o~
the balloQn cathetcr~
'3 ~: - Brief Descrip~ion of tbe Drawi~s F~gllre lA shows a free ballc)t)n inflalable re~action device according to the venti~n in its expanded state.
~; Figuirc ~B shows a fri~e balln~)n infla~able retraction de~ ccording ~o ~he inYenti~n in its collapscd statc.
F~e ~A is a longitudina! cro~s se~lion ~ th~ abdomen showing 8 frcc balloon infla~b1e retraction devicc according to the inven~;on in its collapsed ~ta~e insertcd i~o the abdomen lhrough a small incision re 2B is ~ longi~udinal cross-sc~n of the a~domen sho~n~ a frce ba~loon inflatable retraction device according t~ the ~nvention in its e~pandc~
state pro~ding acccss for an endoscope ~o ~he gal~ bladder.
~: Figurc 2C ~s a partially cu~-away plan v~e~v of thc a~omcn show;ng a ~ec ~alloo~ at~le retraction devicc according to tbe invention in its expan~ed ~ s~t~ pr~dir,~ acee~s fi)r an en~oscope to ~he ~all bl~ddeJ.
Figurcs 3A throu~h 3E show an infla~ablc retrac~ion de~qce ~ccording lo the inventio~ that provides a retraction folce from outside the ~dy, whercin:
Pigure 3~ show~ thc inf'ia~a~le Jct.action de~ with its inllatab]e cha~nher iD its col1aps~d ~tate ou~side thc shaft.
. ,, W~ 92/21295 -- ~ 2 ~ ; 3 PCr/l)S92~04~07 .., `
~igure 3B shows the inflatable retra~ion device with its inflatable chamber ~- in its collapsed state inside the shaft.
~igure 3C shows the inflatable retraction device with its inflatable chamber in i~s expanded state.
Figure 3D shows a version of the in~latable retraction device made using a modified Foley catheter in its collapsed state.
,Figure 3E shows a versio~ of the inflatable retraction device made using a modified Foley catheter in its e~panded state.
~Figure 4A shows an inflatable retraction device according to the invention thati1provides a retraction force from outside the body with its inflatable chamber in its collapsed state, prior to insertion into the abdomen.
Figures 4B through 4E show a longitudinal cross-section of the abdomen with -the inflatable retraction device shown in figure 4A, wherein:
~igure 4B shows the inflatable retraction device after insertion adjacent to ~' the liver.
~,Pigure 4C shows the inflatable retraction device in contact with the liver after inflation of the inflatable chamber to its expanded state.
Figure 4D shows the inflatable retraction device being maniplllated to retract the liver.
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igure 4E~ shows-the inflatable retraction device clamped to a bar t~
maintain the liver in its retracted position.
.~1Figure SA shows an inflatable paddle retractor according to the invention that ,~provides a retraction force from outside the body cavity and has a substantially flat inflatable chamber.
- - Figare SB shows oIle configuration of inflatable chamber of the inflatable ~ir~traction device shown in figure 5A.~ -Figure SC shows an alternative configuration of the inflatable chamber of the in~atable retraction device shown in figure 5A.
~ igure 5D shows details of the shaft of the inflatable retraction device shown figure SA.
Figure 5E shows details of the inflation coupler of the inflatable retraction devioe shown in figure 5A.
~,iFigure SF shows the sheath for the inflatable retraction device shown in figure i. 5~

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~WO 92~21295 2 1 1 0 1 5 3 PCI/US92/04507 `~igure SG shows the inflatable chamber of the inflatable retraction device sh~wn in figure 5A retained in its rolied state by detachable lacillg.
Figure SH is a cross-section of the in~atable chamber shown in figure SB, showing tacking connecting opposite faces of the envelope.
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- iFigures 6A through 6D show a longitudinal cross-section of the abdomen with an inflatable paddle retractor according to the invention, wherein:
~Figure 6A shows the inflatable paddle retractor after insenion adjacent to `.' the liver.
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~Figure 6B shows the inflatable paddle retractor in its expanded state in :.~
contact with the liYer.
Figure 6C shows the inflatable paddle retractor being manipulated to retract the liver.
Figure 6D shows the inflatable paddle retractor clamped to a bar to maintain the liver in its retracted position.
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~Detailed Description of the Imention ,,~
1. FREE BALLOON INFLATABLE RETRAC rloN DEVICES

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(a) Free Balloon Infla~able Retraction Device Figures lA and lB show a free balloon inflatable retraction device according to a first aspect of the invention. The free balloon inflatable retraction device is inserted in a collapsed state into a part of the body, such as the abdomen, adjacent to the organ to be retracted. The free balloon inflatable retraction deviice is inserted into the body through a trocar inserted into a single small i~lcision about 10 - 20 mrn long in the body wall. Once in place~ thé free balloon -retractor is inflated into an expanded state to retract the organ;
Figure lA shows ~he inflatable retraction device 1 in its expanded s~ate. The ~,...... .
em~elope 6 encloses the inflatable charnber 11. The envelope 6 is made of a relatively inelastic and tough film of a plastic such as Mylar/l9, polyethylene, or ,. . .
po~rethane. The preferred material for the envelope is a polyethylene and `~~ylon composite. The thickness of the envelope is typically from 0.5 to 5 mils (13 ~o 130 n~icrons). The envelope can be a polyhedral structure constructed from two segmented, substantially flat pieces of plastic film, which gives the inflatable chamber a substantially polyhedral shape. Alternatively, two non-segmented, ., ,, .

: WO 92/2}29~ 7 2 1 1 0 1 5 3 PC~/US92/04507 substantially flat pieces of plastic film can be used to make a relatively flat inflatable chamber. In a further alternative, two curved pieces of plastic ~ilm can be used to give the inflatable chamber a substantially spherical or spheroidal shape. Preferably, the envelope is made of an elastomeric material, such as latex or silicone rubber, and the inflatable chamber is substantially spherical or spheroidal, as shown in figure 1~
The inflation tube 16 is sealed into the envelope 6. The i~flation tube is preferably a ri~d tube of metal or plastic having an outside diameter suitable for passing through a trocar. AlteFnatively, if a suitable manipulable introducer sleeve is used to place the inflatable retrac~ion device in its collapsed state adjacent to the organ to be retracted, the inflation tube 16 can be made of a flexible material such as plastic or rubber.
The inflation tube 16 allows an inflation fluid to pass into and out of the inflatable chamber 11. The inflation fluid is preferably a gas, typically air, nitrogen or carbon dioxide, although a liquid, such as saline solution, or othersuitable gases may be used. Typical inflation pressures are in the range 0.3 to û.7 psi (0.21 to 0.48 Pa), the preferred pressure being 0.5 psi (0.35 kPa). Oncethe inflatable charnber is fully inflated, and the organ has been retracted, theinfl~tion pressure can be reduced to about 0.3 psi ~0.21 kPa) to maintain the organ in its retracted state. The proximal end of the inflation tube 16 is provided with a valve 21 which controls the flow of inflation fluid.
~ he inf~atable retractor is shown in its collapsed state in figure lB. The main envelope ~not shown) is packed in a collapsed state, and is maintained in its packed state by the sleeve 26 and the detachable lacing 31. The sleeve 26 can alternatively be fitted with a tear strip (not shown) or detachable lacing can be -used alone without a sleeve. As a further alternative, the packed main envelopecan be accommodated within the inflation tube 16. - The cord 36 releases the detachable lacing, but remains attached to the sleeve 26 so that cord can be used to wi~hdraw the sleeve from the body.

(b) Method of Using a Free Balloon Inflatable Retraction Device The method according to the invention of using a free balloon inflatable retraction device according to the first aspect of the invention to separate thebs~wel and the liver to gain access to observe the gall bladder will now be described with reference to figures 2A and 2B.
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WO 92/2~295 ~ 0 1 S ~ Pcr/US~2/04507 ;4 ~' The free balloon ir~latable retraction de rice 1 is supplied with its envelope (not shown) packed in a collapsed state, and maintained in its collapsed state by .~ the sleeve 26. Two small incisions I1 and I2, each about 10 - 20 rnmS long, are made in the abdorninal wall AW, as shown in figure 2A. A trocar T1, suitable ~ti for receiSving the free balloon inflat~ble retraction device 1 in its collapsed state, -~. is driven through the incision I1 into the abdomen! AII additional trocar T2, , . .
1` suitable for receiS~ng the endoscope E, is driven through the i~cision I2 into the '~ abdomen.
~? l'he endoscope E is inserted into the trocar T2 and positioned so that the ~` intendèd deployment site of the free balloon inflatable retraction device 1 can be seen. The proximal end of the inflation tube 16 of the retractor is grasped and ;1 used to inser~ the distal end of the inflsation tube and the packed envelope 29 of `31 the inflatable chamber into the trocar T1. lhe inflation tube is advanced until the packaged envelope lies suitably positioned between the liver L and the bowelB, as shown in figure 2A.
The envelope 6 of the inflatable chamber is released from the sleeve 26 ~y pulliIIg the cord 36 to detach the detachable lacing 31. A supply of a suitable inflation fluid (not shown) is connected to the inflation tube 16. The valve 21 is turned on to allow the inflation fluid to pass through the inflation tube into the atable ch~nber 11. ~he inflation fluid expands the inflatable chamber to its ~: expanded state, as shown in figure 2B. lhe expanding inflatable chamber 11 lifts the liver L in the direction shown by the arrow 41, and retracts the bowel B in ~i the direction indicated by the arrow 46.
The expanding inflatable charnber 11 of the free balloon inflatable retraction device 1 lifts the liver L by exerting a force against the bowel B, and retracts the ... .
- bowel B by exerting a force against the liver L. ~ittle, if any~ of the retraction force is provided by the inflation tube 16.
l'he relative movement of the liver L and the bowel B opens up a passage through which the endoscope E can be advanced to observe the gall bladder GB, as sho~m in figure 2B. Pigure 2C is a plan view showing the off-center placementof the incision I2 which allows the endoscope E to pass to the side of the inflatable chamber 11 to observe the gall bladder GB. Additional small incisionscan bP made to receive trocars through which other instruments can be inserted 3 . to treat the gall bladder.

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. ., (a) S~sf~ Sphencal Ex~ nflata~le R~ra~tion Device ~i~ures 3A throu~b 3B show some v~ations (~n an in~atable retra~ion de~ice S tha~ provides a retracti~n orce frQn outside thc body. The inflata~le re~ract;n~i dc~tice is ~nscrted int~ a par~ of the body, such as the abdomen, through a ~oca~ ¦
'~'`! iDse~d in~o a singlc small incision about 10 - 20 mm long ~It thc bo~y wall. The '; i~flatabh retraction de~ice prov~des a relatively la~ge s~rface area over which a , retr~ction f~r~e provided from outside the body is app~ied.
0 T~e inflata~le retr~ction de~ce 2, shown in its inflated state ~ ~l~ure 3C, '!`'.~ compr~6es a small ~bout 2" ~Sû mm) ~'ameter) infla~ble chamber ? on the distal cnd 4 of a ho~low cylindrical plastic or metal shaft 12 about 0~ nm) in diameter. Thc i~flatable chamber has an envelope 9 prefcrably of ar. elastomeri~~,` material, such as latex, bu~ the envelope can be made of a norl-c!as~ic ma~eriai such as polye~hylene, polyurethane, Mylar~ r a polyethylenc and nylotl l composit~. The sha~t 1~ fits ii~sidc a slandard S.S m~ intemal ~ nete~r tro~ar. t 3 The pro~mal cnd 14 of thc shaft 12 inc~udcs a fittin~ 17 to Ylhich a sourcc of ir~atio~ ~luid (not shown) can be at~ached. rs~e ~;ttin~ 17 inc~l~des a Y~lve 22~; ~h~t enables th~ inflatable chamhcr 7 to bc main~ained in its inflated slale when .j 20 thc source of ir~alion fluid is disconnected.
FiguJc~ 3A and 3}3 show ~he infla~ahlc retrac~io~ dev.icc 2 with its h~a~
chamber 7 in h~o alterna~ive collapsed st~tes. In figu~e 3A, ~he envelope ~not ~how~) of the inflatable chamhcr i~ p~c~.ed into a small volume an~ is held in il~
., p~ d ~atc by thc sleeYC 27. The ~ Ye 27 is hcld in place by the detachablc la~ng 32. Tbc detacha~e lac;ng is detachcd by pulling the st)rd 37. Alternati-~c-, ., - ~, the slecve ~7 can includc a te~r sl~ip (not shown), or thc envelope can bc he]d s packcd statc by detachab~e laan~, alonc, or ~y ~omc other ~uisa~lc mea~.
.~ Thc pac~ccd cmclope fMms a lin~ar extc~sioD o~ ~hc shaf~ 12.
garc 3B, th~ enYelopc 9 of Ihe infla~blc chambcr i~ at~ached ~o the di~t~l cnd of the sh~ft 12 and ~ low v3caum is applicd ~o tl~e ~ing 17 to draw th~
cn~el~pc up inside ~he borc S of lhc ~b~ 12. Once ~h~ envelc~pe has ~e~n stored in ~be shafs 12, the v~ m may be relea~d. ln~ernal storage of thc 3 c~clope of tbe inflatablc ch~mber i5 prcferrcd, and is particularly suitable if thc c~vclppc i~ made of an clastomcr,c m~tcrial. With ~ non-ela~tomeric cnvelope, q _ ~

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~1 2110-153 :.1 10 t~c envclope musl be packèd be.fore it is drawn into ~he bore of thc ~h~.
`, Intc~na~ ~torage cannot be used if ~he packed envelope is too buIky to ~i~ in 1he boJe ~f thc sha~t 12.
. . .
~) ~ethod o~ Ma~ang an Ex~ern~ le Ret~tion De~Ji~ by MDdifying Ba~loon C~the~er An in~atable r~tractor o~ ~h~ type just descnbed for pro~iding a retraclion .~. forcc f~om outside ~he body can be made ~ ~nodify;ng a ~alloon cathe~er, s~lch as a Folcy cathet¢r, as shown in figurcs 3D and ~E. A balloon c~tl~eter has an çlasto~eric in1alable cham~e~ 42 on the cnd ~ a flcxible ~a~he~er 47. The in~latsble cham~er of t~e ball~n cathele~ prcvides the inflat~Je chamber 7 .~j ffigur~ 3C) ~ the inflatable relractor. 'rhe cathet~r of an unm~dificd balloon .~ cathcter, cven when inllated, is to~ nex~lc to allo~ the bal~oo~ ca~heter to apply a ~seabJe rctraction ~rce. A ~nndified balloon catheler according ~ the inv~ntion is shown in its c~l~apsed state in figure 3l), a~d in its expanded st~te 1~ guse 3E. T~e ballo~n ~h~te~ i~ m~ ed by inscrLing a s~ylet ~2 into thc:~ : cathetcr 47. Thc s~y.~t is preferablv in~er~ed such that the di.stal ~nd 57 vf lhc sty~ct substantially coincid~s with thc distal end 62 of tbe ca~beteri i.e., Iheju~ n of the ~atheter 47 and ~he inflatable c~amber 42. lhe rigid s~ylet togethcr with the flexi~lc catheter psovidcs the ~haft 12 ~flgure 3C~ of ~he ~0 l~atable retraction de~icc snd cDa~lcs the modificd balloon c~lhc~er ~o bc ~scd ~3 to re~ract organ~.

(cJ~e~hod of Usn~ a Sllbst~n~ially Spheric~ ern~l ~nf7atable ~e~raction De~ice ~ . .
A Dle~od of using an iDflatablc retraction devicc of the type shown in fig~lres 3~-3~ the livcr so tbat tbc gall bla~der can be observed will now he 't~ ' ,de5~bcd ~h refcrencc to figurc~ 4A through 4E. The ~nethod can ~lso be prac~ced ~Idng an inflatablc rc~ract;on device made ~ modifying a ~alloon c~ tcr, su~h a~ a Fol~y a~thcter.
Thc i~at~ibls rgtraction device 62 is supplied w~th its in~latable ~hambcr 67 3~ in a collapscd sta~c. The cnvc30pc (not shown) of the ;nflata~le chamber is pac3~ o thal it forms a linca~ extensic~n of the shaft 72, as shown in fi~ure 4A.
T~e c~velope is retaincd in its packcd ~tatc by the slc~ve 77 a~d the dctachable~, la~ng 82. ~Itcrnati ~ly, a slccve with a teas strip, detachablc lac~r,g alone, or `' ~3S~

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some other suitable mean3, caIl be used. Alternatively, the envelope can be mounted inside the tube 72, as shown in figure 3B.
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~o 92/21295 2 1 1 0 1 S 3 Pcr/US~2/04so7 . Referring to figure 4B, an incision I1 is made in the abdonunal wall AW and a 5.5 mm external diameter troc~r T1 is driven through the abdomiinal wall. A
`I second incision I2 is made so that a suitable endoscope E can be inserted into .j, the abdomen through an additional trocar T2. The cord 87 attached to the , 7 detachable lacing 82 is run along the length of the tube 72.
The proximal end of the shaft 72 is then grasped and manipula~ed to i~sert the packed envelope 70 and the distal part of the shaft into the abdomen through.i the trocar T1. Once the packed envelope has passed through the trocar T1, the proximal end of the shaft 72 is maniplllated to bring the packed envelope 70 close to the liver L. The shaft is then temporarily clamped in position by '~3 attaching it to a suitable bar (not shown).
-~ The cord 87 is pulled to detach ~he detachable lacing 82 from the sleeve 77.
~, This releases the sleeve from around the packed envelope 70. The cord and detachable lacing remain attached ~o the sleeve so that the sleeve can be withdrawn ~om the abdominal cavi~ through the trocar T1, either irnmediately or at the end of the operation.
A source of inflation fluid is attached to the f~g~ 92. The preferred i~flation fluid is air, although a different gas, such as carbon dioxide, or a liquid, such as saline solution, can be used. The valve 99 is turned on to enable i~ation fluid to flow through the bore of the shaft 72 into the inflatable chamber 67. This releases the envelope 69 from its packed state and inflates the inflatable chamber into its expanded condition, as sho~ in fi~ure 4C. When the inflatable chamber is fully expanded, the valve 99 is preferably turned off and the source of inflation fluid is disconnected. Alternatively, the source of inflation fluid can be left connected and the valve 99 left turned on.
. ~-; The pro~nmal end of the shaft 72 is gripped by the hand H, the shaft 72 is detached from the bar, and, while observing through the endoscope E, the pro~mal end of the shaft 72 is manipulated to engage the inflated inflatable ~: - chamber 67 with the liver L The shaft 72 is then further manipulated to push ,!~, ' ' ' - the inflated inflatable chamber 67 against the liver, as shown in figure 4D. The force applied to the liver by the relatively large area of the inflatable chamber ~' gently retracts the liver so that the gall-bladder GB can be seen through the . endoscope E. When the liver is suitably retracted, the shaft 72 is once rnore clamped to the bar B to hold the liver in its retracted condition. as shown in Sgure 4E.

.

., , ' ` Wo 92/2~29~ ` Pcr/US92/04507 `i 21101~3 12 -~ ter observation has been completed, the proximal end of the shaft 72 is once more gripped and the shaft is released from the bar B. The sha~t is then manipulated to allow the li~er to return to its norrnal, non-retracted position.The valve 99 is operated to release the inflation fluid from the inflatable chamber. The fitting 92 is also preferably cormected to a low vacuum to further collapse the inflatable cbarnber 67. With the inflatable chamber fully collapsed, the valve 99 is returned to its off position. The proximal end of the shaft 72 is manipulate~ to withdraw the inflatable chamber 67 and shaft 72 from the abdomen through the trocar T1. The cord 87, detachable lacing 82, and sheath 77 are withdrawn from the abdomen through the trocar T1 by pulling on the cord 87. Finally, the trocars are withdrawn from their respective incisions.
) `~ (d) Paddle Re~ractor In some procedures, the substantially spherical shape of the inflatable retraction devices just described causes them to obs~ruct access to the tissue to be treated. llle paddle retractor 3 shown in figure 5A has a considerably more compact inflatable chamber than a substantially spherical inflatable retraction device. The more compact inflatable chamber provides a large surface area to engage the organ but is less likely to obst~ct access to the tissue. The paddle ~ retractor is inserted into a part of the body, such as the abdomen, through a i trocar inserted into a single small incision about 10 - 20 mrn long in the body wall.
The paddle retractor 3 has a flat, rectangular, inflatable chamber 8 attached 3 to a hollow shaft 13. The inflatable chamber 8 is enclosed by an envelope 18 made of molded cellophane, about 0.002" to 0.005" (0.05 to 0.125 mm) thick.
Other materials that are capable of being collapsed into a relatively small volume but which conform to a molded shape when inflated can be used. Figure 5B
shows a version of the inflatable chamber 8A having a length of about 3.2"
~; (80 mm) and a width of about 0.8" (20 mm). The thickness of the in1atabie chamber is about 0.2" (5 rmn~. Opposite faces of the envelope 18A may be tacked together with the tacks 9, and as additionally shawn in the cross-sectional view in ffgure SH, to prevent the inflatable chamber 8A of the paddle retractor from ballooning out when inflated.
An alternative inflatable chamber 8B is shown in figure 5C. This inflatable chamber has a length of about 2.4" (60 rnrn), a width of about 2" (50 mm), and Fl;aOM:L11~9CH & L111EFICH 5.F. TO; +49 ~9 239~3446~ Sla lag3+*3 5 '3~94'~

1~ 2~1t~l~3 ~-'` a thic3~ess of a~out û~" ~S mm). The altcrna~e ir~laaable chamber may have the ~ne construction a~ thc inflata~le ch~mber sho~Arr. in Iigure SB.
ReturniDg to fig~rc SA, tbe en~elop~ ~8 is alt~ched to the coupl^~ 23, prefcrably by wdding. The coupler 2~ ~s madc ~ mctal, preferably stainles~ stee!, .. S is hollow, and internal~y threaded, as can be scen in fi~ure ~C.
The th~ the coupler 23 accept ~hc extcrnal tbreads 28 on the di~tal end -.~ of the shah 13 (figure ~D).
The sha~t 13, sho~n in d~tail ;n figurc 51::, has a~ in~ernal bore 93 a~ou~ 0.1~' (2.5 ~un) ~n diameteF~ Ihc shah 13 ha~ an external dia~netcr of about 0.1R"
~0 (4.5 mm) and a length that depcnds ~Il the applic~tion. The range of lengths is from a~out 6" ~lSO mm), Çor use in upper a~dominal opera~ions, to a~out 12"
(300 mm~, which reach to the pclvis ~or carry ng out ~uch operati~ns as ;~ - appendcctomy. The prox~m~l end ~f th~ shafl 13 alsD carries external ~hrc~ds 33.
Ibc cxt~l threads 3~ ~f the shaft 13 al'5 scrcw~d illt~) a couplcr ~, which form~ part of lhe inflation adapter 43, shown in deta~l in figare 5~. The coupler is similsr to ~hc coupler 23, and has ~ne end of ~ shor~ l~nglh of 0.12" (3 rr~n) I
ou~sidc diametcr p]as~ic ~ubing 48 attached t~ it. The p~astic tubing is prcfcrably ~: . polycthylenc, and the pref~cd attach~nen~ method is welding. Simil~ly ~tta~cd ~ to thc othcr end of the p~stic tube is a rc~lLx valve 5~, whieh in ludes the ?~' ~ 2~ coup~er 58, suitablc for acceptin~g a svringe ~n~t shown).
: 'rhe shaft 13 may bc at~ached directly to the envelope ~8 of ~he inflatable chamber B and to the ~flation adapter 43, instead ~f Yia the couple~s '~ and 38.Howeve~, it is preferred that th~ shdft ~3 be de~achable from the envclopc 18 an~l tbe i~fla~ion adaptcr 43, which neccssitatcs using the couplers 23 and 38. Tllis. 25 ~ay, the c~clopo 18 and the inflati~n ada~cr 43 can be disposa~le and thc shaft . 13 ~nd thc shcatb 63 ~ bc rc-steri3ized for furlher use.
lhe- shea~h 63 has a~ exteJna1 diamcter of about 0.22" ~5.5 mm), an internal d;amctcr of abo~t 0.18" (45 mm) aDd a ler.gth of about ~ (150 mm). lllc pro~md cnd of tbc ~heatb 63 is fit~cd urith thc ~lange 8~, w~ich is about 1"
(~5 mm) in dia~etes. lbc shcath fits i~L~ide a standard ~ mm in~err.al di~meter trocar a~d pr~Dects a~out 0.1" (2~ mm) bcyond its c~d.

(e) Me~had oJ IJsing a Padd~ Rerr~ctor 3 A mcthod of USiDg a paddlc Jcsractor to li~t ~he livcr so ~hat ~he gall ~ladde~
bc sbsc~vcd urill n~w be describcd.

3st~

WO 92/~129~ 2 1 1 0 ~ PCl/US92/0~7 `~`.The paddle retractor 3 is supplied with the envelope of the main inflatable , .
`i;chamber in a rolled sta~e such that it forms a linear extension of the coupler 23, as shown in figure SG. The envelope is retained in its rolled state by the sleeve .`S8 and the detacha~le laciing 73. Alternatively, a sleeve with a ~ear strip, or ~ .
"-detachable lacing alone, can be used.
An inciision Il is made in the abdominal wall AW and a 5.5 mm ex~ernal diame~er trocar T1 is driven through the abdorninal wall. The shea~h 63 is then inserted into the trocar T1. A second incision I2 is made so that a suitable -additional trocar T2 can be inserted into the abdomen. An endoscope E is irlserted through the trocar ~2 to observe the retraction procedure.
Thie inflatable retra~tion device is assembled by attaching the couplers 23 and :.38 to the dis~al and proximal ends, respectively, of the shaft 13. The cord 78attached to the detachable lacing 73 is run along the leng~h of the shaft 13.
-~;The proximal end of the shaft 13 is then grasped and manipulated to insert .~the rolled envelope 18 and the distal end of the shaft into the abdomen through the sheath 63. Once the rolled envelope 18 has passed through the sheath 63, the proximal end of the shaft 13 is manipulated to bring the rolled envelope close ~;to the liver, as shown in figure 6B. The shaft 13 is then temporarily clamped in position by attaching it to a suitable bar.
,~The cord 78 is pulled to detach the detachable lacing 73 from the sleeve 68.
;~;This releases the sleeve from around the rolled envelope 1&. The cord and .~'3detachable lacing remain attached to the sleeve so that the sleeve can be t"~'withdrawn from the abdominal cavity through the sheath 63 either immediatelyor at the end of the operation.
.c~.A large syr.inge S, approximately 50 ml, is filled with an inflation fluid and attached to the coupler 58. - The preferred inflation fluid is air, although a .~different gas, such as carbon dioxide, or a liquid, such as saline solution, can be `sused. The syTinge is then operated to drive the irlflation fluid through the reflux :~valve 53, the tube 48, and the shaft 13, in~o the ir~latable chamber 8, as shown in figure 6B. This unrolls the envelope 18 and inflates the inflatable chamber 8.
When the inflatable chamber is fully inflated, the syringe is detached from the coupler 58. The reflux valve closes automatically and maintains the inflation ^ipressure in the inflatable char,lber.
The proximal end of the shaft 13 is gripped, the shaft 13 is detached from the bar B, and, while observing through the endoscope E, the proximal end of the i,i ` WOg2/21295 ~ 7 2110~53 PCl/US92/04507 ..
: 15 shaft 13 is manipulated to engage the inflated inflatable chamber 8 with the ~iver L. The shaft 13 is then further manipulated to push the inflatable chamber .~ against the liver. The force applied to the liver by the relatively large area of the inflatable chamber gently retracts the liver, as shown in figure 6C, so that thegall-bladder GB can be seen through the endoscope E. When liveF is suitably retracted, the shaft 13 is once more clamped to the bar B, as shown in figure 6D.
.~ Ater obse~vation has been completed, the proximal end of the shaft 13 is . once more gripped and the shaft is released from the bar. The shaft is the manipulated to disengage the inffatable chamber 8 from the liver and to allow the liver to return to its normal, non-retracted position. The syringe, in its emptyposit}on, is reconnected to the coupler 58, which opens the reflux valve 53. The~^; syringe is operated to aspirate the inflation fluid from the inflatable chamber 8.
; `j The enYelope 18 returns to its rolled position, which enables the proximal end o ~ .
~; the shaft 13 once more to be maIlipulated to withdraw the inflatable retractior device frorn the abdominal cavity through the sheath S3. The cord 78, detachablelacing 73, and sheath 63 are withdrawn rom the abdominal cavity through the sheath 73 by pulling on the cord 78. Finally, the sheath 63 is withdrawn from the trocar T1.

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Claims

Claims We claim:

1. An apparatus for use inside the body for retracting a first organ from a second organ to gain access to a tissue adjacent to the first organ, the apparatus comprising:
an inflatable chamber means (11) for applying a force between the first organ (e.g.,L) and the second organ (e.g.,B) when in an expanded state to retract the first organ from the second organ to provide access to the tissue (e.g.,GB), the inflatable chamber means:
being adapted for insertion packed in a collapsed state into the body through a laparoscopic incision (I2), and having a thin flexible main envelope (6); and an inflating means (16) for selectively inflating the inflatable chamber means to the expanded state while the inflatable chamber is in place within the body

2. The apparatus of claim 1, wherein the main envelope (6) includes a substantially non-elastic material.

3. The apparatus of claim 1, wherein the main envelope (6) includes an elastomeric material.

4. The apparatus of any of claims 1, 2, or 3, wherein the inflating means (16) comprises a flexible tube sealed into the main envelope (6).

5. The apparatus of any of claims 1, 2, or 3, wherein the inflating means (16) comprises a rigid tube means scaled into the main envelope (6).

6. The apparatus of claim 5, wherein the rigid tube means (16) is for providing little, if any, of the retraction force.

7. The apparatus of any of claims 1 through 6, wherein the apparatus additionally comprises a detachable means (26) for maintaining the inflatable chamber means (11) packed in the collapsed state while the inflatable chamber means is inserted into the body through the laparoscopic incision.

8. The apparatus of claim 7, wherein the apparatus additionally comprises a means (36) for detaching the detachable means (26) prior to the inflatable chamber means being inflated to the expanded state.

9. The apparatus of any of claims 1 through 5, wherein the inflating means (16) is for providing little, if not any, of the retraction force.

10. The apparatus of any of claims 1 through 9, wherein the inflatable chamber means (11) has a substantially spherical shape in the expanded state.

11. An apparatus (2,3) for providing a retraction force from outside the body to retract an organ (e.g.,L) inside the body to gain access to an adjacent tissue (e.g.,GB), the apparatus comprising:
an inflatable chamber means (7,8) for engaging the organ; and a shaft means (12,13) for manipulating the inflatable chamber means to retract the organ, the shaft means including:
a distal end (4,23) to which the inflatable chamber means is attached, a bore means (5,93), communicating with the inflatable chamber means, for inflating the inflatable chamber means to an expanded state when the inflatable chamber means is in place within the body, and a proximal end (14,38), the proximal end remaining outside the body when the inflatable chamber means is in place in the body.

12. The apparatus of claim 11, wherein the inflatable chamber means (8) is flat, and substantially oblong.

13. The apparatus of claim 12, wherein the inflatable chamber means (8) has a width, a length, and a thickness, and the thickness of the inflatable chamber means is less than one tenth of the longer of the width or the length of the inflatable chamber.

14. The apparatus of claim 11, additionally comprising a reflux valve means (53), attached to the proximal end of the shaft means (13), for maintaining the inflatable chamber means (8) in its inflated state.

15. The apparatus of claim 11, wherein the inflatable chamber means (8) is defined by an envelope (18), the envelope is rolled (Fig. 5G) when the inflatable chamber means is in its collapsed state.

16. The apparatus of claim 15, additionally comprising detachable means (68) for maintaining the envelope (18) in its rolled state, the detachable means being detached before the inflatable chamber is inflated to its expanded state.

17. The apparatus of claim 11, wherein the inflatable chamber means (7) is substantially spherical when in its expanded state.

18. The apparatus of claim 11, comprising:
a balloon catheter (42 + 47) having an inflatable portion (42) and a flexible tube (47), the inflatable portion of the balloon catheter providing the inflatable chamber means (7); and a rigid stylet (52) inserted into the flexible tube, the rigid stylet and the flexible tube of the balloon catheter together providing the shaft means (12).

19. A method for retracting a first organ from a second organ in the body in the course of treating a tissue adjacent to the first organ, the method comprising the steps of:
providing an inflatable retraction device having a collapsed state and an expanded state;
making a small incision in the body;
introducing the inflatable retraction device in the collapsed state into the body through the small incision;
placing the inflatable retraction device in the collapsed state between the first organ and the second organ; and inflating the inflatable retraction device to the expanded state to apply a force between the first organ and the second organ to retract the first organ from the second organ.

20. The method of claim 19, wherein the step of providing an inflatable retraction device provides an inflatable retraction device comprising:
an inflatable chamber including a thin, flexible main envelope, and having a collapsed state, and a means for selectively inflating the inflatable chamber to an expanded state while in place within the body.

21. The method of claim 20, wherein:
the step of providing an inflatable retraction device provides an inflatable retraction device including a detachable means for maintaining the inflatable chamber in the collapsed state, the method additionally includes providing an insertion tube, the step of introducing the inflatable retraction device in the collapsed state into the body includes:
inserting the insertion tube into the body through the small incision, and pushing the inflatable chamber in the collapsed state through the insertion tube from outside the body, and the step of placing the inflatable retraction device in a collapsed state between the first organ and the second organ additionally includes the step of detaching the detachable means to release the inflatable chamber from the collapsed state.

22. The method of claim 19, wherein the step of providing an inflatable retraction device provides an inflatable retraction device including a detachable means for maintaining the inflatable retraction device in the collapsed state, the method additionally includes providing an insertion tube, the step of introducing the inflatable retraction device in the collapsed state into the body includes:
inserting the insertion tube into the body through the small incision, and pushing the inflatable retraction device in the collapsed state through the insertion tube from outside the body, and the step of placing the inflatable retraction device in the collapsed state between the first organ and the second organ additionally includes the step of detaching the detachable means to release the inflatable retraction device from the collapsed state.

23. The method of claim 22, wherein the detachable means includes a peelable sheath, the step of detaching the detachable means includes the step of peeling the peelable sheath away from the inflatable retraction device.

24. The method of claim 23, wherein the peelable sheath includes a tear strip, the step of peeling the peelable sheath includes the step of removing the tear strip to release the peelable sheath from the inflatable retraction device.

25. The method of claim 22, wherein the detachable means includes removable lacing, and the step of detaching the detachable means includes the step of releasing the removable lacing.

26. The method of claim 19, additionally comprising:
providing a surgical instrument;
making a second incision in the body; and passing the surgical instrument through the second incision, past the inflated inflatable retraction device, to treat the tissue.

27. A method for providing a retraction force from outside the body to retract an organ in the body in the course of treating adjacent tissue, the method comprising:
providing an inflatable retraction device including an inflatable chamber, and a hollow shaft having a distal end and a proximal end, the inflatable chamber being attached to the distal end of the shaft in a collapsed state;
making a small incision in the body;
manipulating the proximal end of the shaft to pass the inflatable chamber and part of the shaft into the body through the small incision, and to place the inflatable chamber adjacent to the organ;
passing a fluid through the shaft to inflate the inflatable chamber into an expanded state; and manipulating the proximal end of the shaft to engage the organ with the inflatable chamber and to retract the organ.

28. The method of claim 27, wherein:
the step of providing an inflatable retraction device provides an inflatable retraction device additionally including a detachable means for maintaining the inflatable chamber in its collapsed state, the method additionally includes the step of providing an insertion tube, and the step of manipulating the proximal end of the shaft to pass the inflatable chamber and part of the shaft into the body, and to place the inflatable chamber adjacent to the organ includes the steps of:
manipulating the shaft to push the inflatable chamber and part of the shaft through the insertion tube from outside the body, and detaching the detachable means from the inflatable retraction device.

29. The method of claim 28, wherein the detachable means includes detachable lacing, and the step of detaching the detachable means from the inflatable retraction device includes releasing the detachable lacing.

30. The method of claim 28, wherein the step of providing a detachable means includes providing a peelable sheath, and the step of detaching the detachable means from the inflatable retraction device includes peeling away the peelable sheath.

31. The method of claim 30, wherein the peelable sheath includes a tear strip, and the step of detaching the detachable means from the inflatable retraction device includes removing the tear strip to release the peelable sheath.

32. The method of claim 27, wherein:
the step of providing an inflatable retraction device provides an inflatable retraction device including an inflatable chamber having a substantially oblong face having a length and a breadth, and a thickness that is small compared with the length and breadth of the oblong face, and the step of manipulating the shaft to engage the organ with the inflatable chamber includes engaging the organ with the oblong face of the inflatable chamber.

33. The method of claim 27, wherein the step of providing an inflatable retraction device provides an inflatable retraction device having a substantially spherical inflatable chamber.

34. The method of claim 27, wherein the step of providing an inflatable retractor includes:
providing a balloon catheter having an inflatable chamber and a flexible tube, providing a stylet, and inserting the stylet into the flexible tube to provide the shaft.

35. The method of claims 27,32,33, or 34, additionally comprising the step of clamping the proximal end of the shaft to maintain the organ in its retracted state.

36. A method of making an inflatable retraction device for providing a retraction force from outside the body to retract an organ inside the body to gain access to an adjacent tissue, the method comprising:
providing a balloon catheter (42 + 47) comprising an inflatable chamber (42) and a flexible tube (47);
providing a rigid stylet (52); and inserting the rigid stylet into the flexible tube.

37. The method of claim 36, wherein the flexible tube (47) has a distal end (57) adjacent to the inflatable chamber (42), the rigid stylet (52) has a distal end (62), and in the step of inserting the stylet into the flexible tube, the stylet is inserted such that the distal end of the stylet substantially coincides with the distal end of the flexible tube.