CA2698729A1 - Device for intermittently obstructing a gastric opening and method of use - Google Patents

Abstract

The present invention relates to a device for intermittently obstructing a bodily opening, such as a gastric opening, and includes a proximal member connected to a distal member by a tether. The proximal member includes an apron member surrounding a first occluding member, which is formable from an elongated and narrower configuration to a contracted or expanded but wider configuration. When employed in the stomach, the device of the present invention is arranged transluminally, with the distal member disposed in the duodenum and the proximal member disposed against the pyloric valve, intermittently occluding the pyloric valve and preventing or delaying the flow of gastric contents through the pyloric valve. In certain embodiments, a reservoir may be included for releasing a substance of interest, for example for releasing insulin from a reservoir disposed in the distal member.
Sensors, actuators, and data transmission devices may also be included.

Description

I3EVIt;E FOR IN"[ ERANN-1l I.'I'EN"I'L1' 0B4"tRU('".C[NG A LaASTRK' OPENlNG
AND

M.~~THOD OF t.t S~."..~

C-ROSS-RFFERENCE `I`C) RELATED APP11t:A`I`I.ON`~

100011 This application claims the benefit of priority to U.S. Prov. Pat.
Ajlp.
64 `9'fl,ti 1 9 filed September 7, 2007; wh:icl:i is Rtc(yrpora3.ted herei.li by -reiel ~iiLe i11 iis ettti rety.

FIELD OF THE INVENTION

100021 The preseiit invention relates to aga4tro-lntestl.nstl tiev~ce for treating cgbesitv and other medical c:c4nditions, More partic.t.tlar(y, t(xu present i~ivuiition relates to a device that is positioned trati51umitially iÃ-t a pati~iit's =Fastro-inte5t:itial tract to interm:ittently obstruct or reduce the flow of gastric content4.

1.0 BACKGROUND OF TRE INVENTION

10003] Obesity is a condition of epidemic prcgporticgils in the United 5t.ates, Receiit government siudies_[lave ai-idicateti that up to 401' "0 of Americans are obese ~iid that, among those, almost 20% are morbidly dbese. C~be-sity is tiot t:lie, problem in and of itself, but is the source of m-L-ltip(e patholoWcal conci.it-ions, inclurlim, cardiovascular disease, heart disease, stroke, diabetes, and obstructive sleep apnea. Recent sttÃdies have iiiclic_ated that obesity can retiLice aper4olY's lifespan by an aversq>e c4f three years in adults and M.~enty years in c_1ai f dreii.
[00041 Many atten$pts h~~~e b~.~eri made in the prior art to provid~.~
triedications, c~evices, and sur9:ica:l p:roLetlures, for the treatinent of obesity, all of which either 1~ave yer:iotrs side effects or are basically ineffective. For example, z>ariotÃs diets, SUpplements and lal~arlnaceutiLala _[lave been developed aiid naar"keteti; bui ii~~i-ie have shown ~iiy significant benefits to date in the treatment of obesity with tbe exception of some pharz~~~~euticals, which have uniorttlnatelv been.t`ound Ã:c) cause a iilimber of sedo s, fit:ercÃh~~e'atening medical condit:iotis. To datez there al:e l~o cozrimer~iall~~ available supplements or drugs that have been. pro~~~~i-i to be effective in promoting significalit weiglit loss ~i-itl at the same time that are tree troni serious collateral side etfi~ct:s.

~

[0005I Re~og)-nizin`.~ that t7o ctire has beez3 s,leveluped to dti#e that i;s bot1i effective and satea the nicdical indtastry has imrotlut:.etl morc extre~-ne ~.~roc:~~duresa ai3 exam.p1e of'which is Ã1;7e houx Enr1~'` gastric bypass. This extensive and invasive surgerv.is 1~igh:[~~ effective bLiÃ
is also poteiitially lethaI, wit:li a 12% mortality rate, a six mt?rith recovery period, ~~id a :? cost of Ã~ii;-, of Ãi7c~us-ands of dollars, yet it is becoming ancreasi.tig1y laopLilar bec:.atise other available treatments do iiot prodtlce the desired results. Gastric redtlctioti, or simply ri`anoving a It~~ ge segment of the stomas;h, is ariotl~ier pros;edL3re that is sia-nilar to gastric by~pass and tliat, like gastric. bypass, has also beezi associated witb potentially, letlial complications. Data ~~om rec.erYt. 4tudie4 have indieated. that even in the lowest risk ;Froups, 1.0 obesity surgery causes ~~~ average one-year nioz-tality j.'ate of nearly 5~i,.
~00061 In another att~rnpt to treat obesity, devices liav~.~ also been developed in the prior art that are aimed at providing a sense of fu11ne;5 to a patietit so to catise the patient to redtice food iritake. Stich devic-es ii1ay be c~~ifigured as steiits that ~uplaort tizo stomach or the py[oric valve to or t[iaà rz-iav be configured as perrnarzent occlucclers.
t;#nfo.rt natelz, I;> these devices are implanted in the patient c?~~ an essetitially permanent basis atid tviiicallv include complex r-ziechanica:l or eIectricial .feiatures that r-ziztv stop working properly over tirne or that may require maintenance from time to t:itzie. l`:xaniples of such devices M the prior art can be fEgaind in U.S. Patent Nos. 5,509,95S; 6;067,991; 67,527,701;
6,6S9,046;
T,f3l lz62 l ; 7,737,344: 7,120,498; 7,122,058 and 7,167,750, and iri U.S.
Patent Application 20 Publications Nos. 2004/0172142' 2005/0273060;. 2007.'0016262:
21007:r0027548; and 2007f00832 -14.
100071 Evidetice bas been developed showing that beriefits can 1}e, Ãlerivetl. froill redaFci.n;~. wastroduodenal flow. In unpublished, b à reCezlily presented data at Ãhe.Americin Society for Bariatric Surgery conferc..nee: of Jt-~ie 2003, stimt:ilati~.~Ãi of thc:. gastric vagus 25 iierve with su~~~eq1~ent redticÃion in gastric motility restiltec,l in a[oss of over 20{'~"() of excess weig:llt over a nine month poriod. Furthermore, there is data suggesting that gastric.
va;=otomr, is alst? effective in the treatment of obesity trt?uuxh a similas-a-nechani;M.
t?nfortzinat:ely, these therapies reqtr:ire highly itivas:ive, sometimes irreversible, sur~?,:ical proc~.~klti:res, making them undesirable frgr a larg~.~ segtzient ofth~.s obese population.

OF TlJE lNVEibvTIO:'~

(04081 It is an object of tlao present invention to provide a device for the treatment of obesity and related. conditions that iiatermittentl~~ obstructs a traaaslumiaaal passage, sucla as a ;;awtrÃc capeni.114.~:.
100091 It is also an ol~ject of the pre~ent inv~.~rarion to ptovide a device for the t:i-ciitaiictit of obesity aud relfiÃ-ed conditicaus ilaaat is well tolerated by Ãhe s-ornaach and i.ta. ge~ieral., bsf the gastro-ialCi4Cit:fa1 tsact, 100101 It is a fiarther object of the present i~~~~entiora ti.~ provide a clevice for the treatment of obesity and related c;oÃ-tdiÃioxts t1aat c;axi be implanted and r~iiioved witl-t 1.0 n$odical procedLares that are saafo antt relatively sin$ple to p erforna.
100111 Brie-fly, the device of the present inventioaa Operates as a transluminal device that obstraicts the pylorus or other organ on aia intermittent basis and that causes a reduced flow of gastric contents iato the .iaitesi-incil mact. 'I'lae device of the present .Ãaiveaitiora ay-iay just t-acciipy space in tlae stomach aia~ occliide the pyloric valve, from time to tinae; or also 1.5 Taa<ay partially tat}sti-act the duocic:r:twri or the syaaa(l intesti.r:te, reducing overall gastro.i1.1tc:sti.laal tran4it. The intemiitteiit b1oc:kst~xe of the gyastroi.ntustina1 tract resti(ts in weight loss wi~.l also in an increa4ed. or sL3st.air:fed tee1ing of fii(1r:fess by the patient.
100121 The device of tlao present invention can be placed. aiad removed with si.11aple en~.losc_opic procedures and is c:ompIutely reversible. l:r:f ~.~sartic.uIar, t(xu device of'the present 20 iÃ-tveÃ-ttion c;axt 'lae iÃ-tsert~d aÃ-td reznc~~~ed orally, Ã-tasa11y or traÃ-tscaitaÃ-teoaislN, and, in ceriaiil enakaodinaents, c<$n be t.ri~gerjM externally or car.a be. causm:d to expand or c{iai self=expaa.rzcl tS.t1t;e 1.t1 the gasÃI'olI7tE'.StdTiaAl Sp<3cE'..
(0013] In one ei-ta~.~Ã~~diiaicaitw a device according to the present in-ti~e:ntion incltides a tjromÃanal Ã-neznber o.rÃeaiied in the direction of tl:ie sÃoznaLh. after imp:laiatat:ioai and a di;;#ril niember oriented in the direction of tlio duodenum after implantation that are, connected by, a totl wr.
100141 The proximal member is composed of a first occluding member stxa'rot.~~idecl -t~y an apron member. The first occluding t1iembur is formable from an elongated, narrower configuration to ~.~ co-ntrileÃeci, wider configuration, while tl~~ apron meaaiber bas 111 '30 essentially ey(intlrica( portion that surrounds the first ocx.:ltitliaig member an~.~ wi essentially cozi.ical pt~rÃ.iozi that z.on-nects the aaprora r~-iemtaer to the tetlaer, prtavidiai- the taprozi nier~~ber with a fun_nU(-li.ke sbape., In one embodiment, the c:ylintlrie.aI portion is spaced fi-oan the first occ1ur.1_ing member by an interstice, and t:he. cylindrical and conical portirfÃ-ls mav have.
d.i fferent wall thickness.
(OO151 I'lre first oc:.cluct..i~~~ member may be formable frott-i the narrmv:rr zo-nfiMtiaaiion to the wider coÃifiratioti bv injecting a stibqaÃiee witbin the first occitÃdiÃig member, or naav have a sol.id structure that can be compressed to assume a.ti ea.paiit.lerl sltape, :iti order to transition form tbe elongated ccÃnfigun, tion to the wider cont=Ãguratic?n.
100161 1i1. one eml;aodiaZ~ierit, the elongated c:orÃiig,ur-ation exh.ibitS a hel.ical contour wit:li a p1tarality of turns, and the wider configuration is tormetl -rom the helical configuration by nesting, the tLÃms e~~~e adjacent to the otber to provide a bulbous body. The wider 1.0 eonf"iouration is tlieÃi [ocked in place bv enga~g.ing. a connecting ÃiiembeÃ- at the proximal end of tb~.~ :{-irst occ1udin ~ rt~~~:Ã~~.1~e~~ d~~itli a Ã~~~Ãti.Ãi;= c.avit-4' at tlic c~ist~~l end of the t~rst c?cclÃ:~t~ing meÃyiber. Tki~ inay be acliiet~ed by having a clinician pull c~~i a string cotÃpled to the com1eCt#11g rTZeT3l1b1 .r in the d1r~ectli?Ii of ttie rllatlrlr cavity.
[00171 In otie embodiment, siiL:[l co pI.ing ytr.i~~~ extends outside ot.'Ãt7~
device aloii;.s its I;> entire length atid then enters a liÃaiien running ~-Ã~om the first occluding meniber to the secÃz.Ãid occluding i:Ã-~~rnI~er; through tl:ie tetl:ier. W~en ciiteri~-ig tl:~e first Ãzcc1tÃciif-ig naember, ttie string is loolaed through the connecting meÃ-iibe.Ã- and is removable f-rom the device after tlxt conÃ-iec ting Ã-nerziber has cris~aget1 the rziatching cavity'. The proxiÃ-nal end of the first occluding ~:~~.e~~tl,~~r Ãiia~~ be reinforced to increase its resistance to tear during the 20 cotlilare4,ion of the first occluding mersiber bv including, a reinforcing material in at least part of ttio structure of the proxinia1 ond..
100181 The transfcÃrniatic?n process from the eIonMated ~onfiguration. to the wider confi~.~aÃi-ation is reversible, so that the cle-vice c~i-i be imp(~i-ited in the stomach in the c:lÃ~~~~gated configuration, reside in tlie stomach aÃ-idf~.~r gaStrÃ~~-iiitestinal tract in the wider ~5 conti-uration; aÃid be removed froÃ-ii t[ie stomach ÃhÃ-olÃgh ttie eaoplaa.glÃy in the elongated contigurat:ion. In one embodiment, t:l~e, wider contigtirat:i~~~ reverses to ttie elongated confi;=Ur-atit3n br, severing tl~c connecting memb~.~r:{-roÃn the proximal ~.~nd, fc?t~ ~xarÃipl.e, by having a cli:Ãiician cut a string coupling the connecting member to the proximal end or to a:
t-~.'lea,e tnemb~.sÃ- in the proximal enci.
-30 100191 A device according to the present niaterial is matiutacttÃred frozll a material that is bioc~omtaatible., that is able to witlistatid the gastrointestinal environment, and that p~~evey-its or ativways m:ininai:r.es abrasion of the walls of the stoÃ-n.acl.Ã and duodeatÃna, particularly Of t.~~e. pyloric. valve. In one embodiment, the device is manufactiÃred from a resi1iet:tt plastic niaterial, for exarz-iple,, f:rom>Ã silicoiic material, aÃad the apron me.mbcr may be constructed to be flexible erizaugh to devezae t=rom a position surrounding a portiot) of the tether to a position surrounding the first occluding mernber, iri order to facilitate insertion in t[ie stomach aceot-ditag to oa7e i-aaeÃttod of Lise.
100201 The secc?ia~ occliidi~ig zneaaiber also may [iave a buIbotis slaape.
like a pod, and include aia iiiserà having a 1~~avier weiglat than the remaiia~er of the ~ecoliii oLcIuding aa~ember, so to fiaciIitate, disposition atad retention in t:~ie.
da.iodentiaal.

100211 The t~evic:e. of the present invention i.s stÃited not only for the treatment of f-)besity, but also for treating ottaer ailznezats, such as improper g1a.acose tolerance in a dia%+otic or prediwibetic subject and. the ~.-~roggres;ion of diabetes itself bv inhibiting hi4ting 1.0 iÃ-astaliia secretion c~~' glucose-stimulated insulin sec_reÃioxt. 'I'lie re5extt device is also stiiÃed toi= treating other ailments deriving ti~~~~~i obesity, including hyperphas;i.a, d4=slipiden$ia, Prader Wil.li 5~~ildTo-iiae, F.rcaolick`s syndro-me, Cohen 5~~ildTo-iiae, Stai-aamit syl:7drome, Alstr~ii~ syiidr~iiie. Borjese~~ sviadronie, i:3ardet-Biedi s}=ildronic, or hyperli~.suproteineaa.1ia, types 1, II; II_!, a~id IV.
I;? 100221 The device of'tbe preseiit itiventic?ia may also include sensors or transmitters to provide i`~edtwk aiid other datia to aii .Ãntx-arcorporeal or extriarcorpcaz~~~l processor, or may carry o"ne or more eompoLia7c~~ st~~~~ed iM a reservoir within the device or coated oia the t1evice. In. osxt enibodiment, iil&3lirl is released ii-itEg the gastro-intestiri4s1 tract by disposing an insulin reservoir in t:~ie. distal meznl~er of ttao device. ;5tich a release of itastiliza may be 20 controlled by the size of the orifice between the reserL'C)1r w1d the oLlter onvirotlment, or by a time-controlled actuator, or by an actuator ccantrolled. by one or aaiore sensors, for exa.rrqsle in respcaiase to ~.-~etec-tioia of sugar in the gastro-intestinal tract.
1.00231 C3tlier embodiments of the present invention, naethodR Of se Oi' ~1 deVi.ce manufactured according t~.~ the pre.sciat inventi~.~Ãi, aaid methods of tre.atme.nt of a variety of 2 5 aali-aaenÃ:s usa~~g the de~ iLe of the ~~reseizt i~~ve~~Ãac~ta are ~iiscLissed in ~iet~.i1 iiz t[~c fiallowing Sectii'3I3s.

BRIEF DESCRIPTION OF rl^HE SEVERAL VIEWS OF THE DRAWINGS

I0024] "('lte drawings constitute apark of this specification ai-ad iixcluÃI~
~~~tTaplary e~~ibvtli~~ieiiÃ-s of the inventiou, wliicli may be ernbodieal i.n vra_rious forms. :[Ã- is to be 30 rriaderstood thaà in sonae .inst:ances varioti5 aspects of the ia7vea7tioia may be slamw7 etiw~ggerated or clYlargeti to facilitsate. wY L3nel.erstaaidiaig of the invention.

[00251 Rt.f, iA illustrates a perspective vie1yv of a first eÃ-iibodimetii of the inventicsn in the elongated, narrower confid?'ltrc.itiZ)11.
(00261 FIG, 1B illlist-rat~s a perspective view c?f the emboelirt-~ent of FIG, l:'i in the contracted, wider contigurat:i~l.).
[00271 FIGS. tC'-lE illustrate reapectiveiv a cross-sectional view of the proximal ~~~ember of the embodiment of FIG, ii~3, to w[iieh a protective cap has ~~~~l added (FIG.
1C); a ;ide. view of tttc embodirni`nt of FiCi. 113 with t.l$e. protecti.~~~
cap (FiCi. 1D); a~~d a cross-sectional view of the embodiment of FIG. i D {FIG. 1E}.
100281 FIG, iF illustrates a cross-sectional side view of one eximp(e of a tlevice 1.0 having a sensor ineorporf'Ited wiÃhiil for confirming or detec_tixig whether the twc [udiniw mer~~ber has i~ecri locked isito its tiep1~~~~s-n~.~nt cosi#iguratic?n.
[00291 FI(_iS. 2A-2t_; illustrate r~~~~ectively a cross--~ectiunal sicle view atid top and bottom e~~d views of aiiotiier embudÃment.
[003{31 FIGS. 2D-2E i[l1i5trate respective side aticl cross-;~ecti~~~ial perspective views of the embodiment of FIGS. `-A-?{:'.
10031.1 E'IC3S. 3A-313 illusmate side and cross-sectional side views, respectively, of yet another embodiment where a~i occluding ~~~~ember is separately fabricated c~.ti~ removably attachable withisY iin aprEgn:tnember.
100321 FIG, 3C il1tistrates a cross-sectional side view of an assembled device from FIGS. 3Aar:fci ')B, 1903:~] FIG. 4 is a grapii depicting the efficacy of t.t~e, first eziibodiziient of the i~lveiltion in differeiit variaiits.
100341 HtF. 5.1s a partial cross-sectional side view of tl:~e proximal portion of 1 seec~i-ict eÃ~itiodiÃiieiit of the in-v~e:rition.
2 5 (00351 FIG, fiA ia a }~art.ial cross-sectional side view of a tlai.rccl embodiment of the i~ivetit:i~t.i. while FIG. 6i;3 is a side view of a variant of t[ie enibodimeiit of FIG. 611..
100361 FIG. 7 isa partial cross-sectional side view of the iri-iboctiti-iosit of FIG. 6A in partiillv deployed state.

100371 FIG, S is a partial cross-sectional 4ad.~.~ view of t(x~ ~t-nbodit-nent of FIG. 6A in 3 0 the elongated, narrower configuration.
190m] FIG. 9 is a partial c-ross- sectional side view of a fourth embodiment of tbe invention.

[00391 Rt.f, 10A is a partial cross-sectional side view of a detail of a fifth embodin-~ent:
of the it3vet3tiori, while F1Ci. 1013 is, a perspective vitvv of the first occluding mem:l~er ot'th~~
embodiment of FIG. 10A1.
100401 FIG. 11A is a cross-sectional side view of a detail of a sixth eziibodiment of tbe invention, while FIG. 1l:B is a perspective view of the first occ~.I dim~~
member of the embodiment of FIG, i i A.

100411 FTGS. I2A-12I3 are cross-sectional side views of a siveritl~ ~~~ibodii-lierit of t~ic in3~ent:ion, in adep1nyed state (FIG. i211.) and in a part:iallv deployed state (F:IC;i. 1213).
10042] FIGS. 13A-13B are partial cross-sectional side views of an eighth embodiment 1.0 of the invention.
[00431 FIG. 14A-1 4B are cro;s-,ec#-iona1. side views of a tiiTith embodiment of the invention, in the cloployed state (FIG. 14A) ar~id tiiitlep[oyed state {F[Ci.
14B1, wlzile HCi.
14C illustrates a detailed view of the cui-niect:~~~ ~id retaining menibers in t:iie. eiizbodisiie-iit of 1'It~3S, 14Ar 1.4.B.
100441 FIG, 15A is a furtber cross-sectional view of the embodiment of FIG.
14A, while I"IGS. 15Brc15D .iliustrate detailed views .if Ã:lte cotipIi~-ig of the connecting metriiier with the mating cavity.
100451 FYCi. 16A is a cros,-sec:tiosYa.l side view of a tenth embodiment of the i~~~~~i-itiosx, wbile FIG, 16B is a detailed view of the connecting element of the embodiment of FIG.
16B.
100461 FIG. 17 is across-sectiona1 side view of tbe embodiment of FIG. 16A in tbe un~:-~elaioved state.
1.00471 1:'ItF. (i; is a crossr sectic~~ial side view if a v>ar-iaiit of the embodiment of FIG.
I 6A.
2 5 100481 FIG, 19 is a c:.ross-seLt:ior7a1 view of a Ãwelftl~~ embodiment of the anvetiÃion.
100491 FiCS, 20A-243t : 21A-21B: and 22A212C are. side views of different ~s-tibodii-tietits of the iirst occltiti:irig member in the eti-iboclin$~iit of 1=TC-i. .19 atici of their ~~iocie of cleployment.
100501 FIGS. 23A-23C illustrate a device introduced in t(xc stc~rrivtch or other parà ofth~~
~~0 (Yastro-intestiria1 tract in an o1ong ated configuration i FIG. 23A:f, expanded to an inter~~~ediate configuration (1;IG, 23B) and to a final configuration (1;IG, 23C) by injecting a4bam ovrithan appropriate catheter.
100511 1FICS. 24:~-24C iliustrate a proc-ess sÃiiiilai- to that of FIGS. 23A-23"t;. e:~cepÃ

thatÃt substance such as water, a 1'Caw;e]t <3I7d;`fS.T' a f`.i~talyEit. is )i1}ect3'd thrt?13wl1 thC'. L`.at~7~:et.E'.I'.

[00521 FIGS. _25Ar~5C illustrate ~~~ematicall~ a mode of plaÃ.etnent ot'the devices of F1C-S. 23A-2'W 4ir-id 24A-~24C throtÃ~.sh a catheter i:tt:trotittced through the esopI~agtt; {FI.G.
25A), then Lised t.'tir intusing t.'oarn or a growtla slibat:ance (FI(J. 25I3}
atid eveniLially causing the device to become fttlly inserted (Fi(} 25C). Converse-1y, FIGS. 26A-261) illustrate tbe removal of ytiet7 a device by showing the device in its placed state (FIG.
26A), the attachment of a. device extractor (FIG. 2613), the activation of predetermined failure poitits (F1C'~. 26C), and t.lie extraction of the clovie,e (FIC'~. 26D).
100531 FIGS. 27A-27C illtastrate other embodiments, in wizich multiple distal bt,ilbs {FIC
i, 27A) or a larger di4tal bulb (FIG. 2713) may be present to slow transit of fcgoti i_tY the 1.0 aastrointestina[ tract, or in which tlo distal bulb.may be present axicl the device eati act as a spac~.~ filler (FIG. _17+C.}.
[00541 FI(_iS. 2SA--28C illustrate a mode by showingit7st.~rt:iot7 (Ff.G ?8A}, itif7;itiotl of tlze bulbs (FIG. 2811), atid tlze intestinal migration of the distal bulb (FIG. 28C). FIG. 2281=) il[tisÃrates t[ie obesity treatnienÃ: enhanced by adding gasÃric fille.rs in the stomach.
100551 FIG. 29A illttstrates a cross-sectional side view of ati embodiment whet'e, an Ãzcclticiir:tg r-ziember naav be toIdecl within ia .receivi.n.4,~ channel such that a ci:isÃaI protrusion is mated in a secured nia.t7net within a tz-iataitg cavity.

100561 FIG. 29B illustrates a eross -sect:ionttl side view of another embodiment where the distal protrusion is cc?nfigUred in a sbape which resists or inhibits withdrawal frotii the mating c's1vi C y.
100571 FIG. 29C illustrates crc~~~~seeÃional side views of yet atioÃber embodiment where t:lie, device z~~ay be c-o1lapsed by actuation ofa Ãetisit~tiiti,.y wire or string-la0: fi1 I:'IG& 30:'L ~i-ict 30B i11tistrate croqs-see.ftonal ~~~d views of a(tet7:iatÃve vat-1ltions of tlie dev-iee: of FIG. 29C where reSpe.cti-v~e: mating st.irface.s of the collapsed device Ã~la.v ?5 it7corpo.rate adhesion or itiier"[ockai-ig sttrta.ce teattii-es ttir securing the c.levice .in its collapsed eonfitwt.trat:i~l.).

DEr1lAIt..ED DESCRIPTION OF EMBODIMENi~S OF {l'HE -I:VEN':l^ION

100591 Detailed descriptions of embodiments of t;tic inv-etiÃion are provided herei.n. It is to be understood, 1.iowever, that the pre.sent inve.nt.iou may be ernbodied i.n various form.s.
Therefore, the specific details disclosed hezei~-i are not to'be interpreted as limit.ing, biiÃ
rather as a repr~~seiitative basis fcgr teaching oiie skillud in the art }iow to employ the t.-~r~~seilt nive.uti.on in virtually any de.-aile(l sysÃe:ni, structure, or nzan.ne.r.

[00601 Rt.f, IA depicts a l=irst embodit3-~ent of the i1.1venticsn, -whic;h is configured l(yr insertion into a patiem's orgar3, typically tlic stomac;li.. Device 30 i~-icltÃdt, a pt-oxintal member 32 and a distal naember 34, ~.~~hic_[i are connected ~~i-ie to the ot[ier by a tether 3&
-I'he relative sizes of proximal member 32 atid of distal iiiember 24 are such that, after insertion itiÃ:c) the stornach of a paÃient, the i-iaiiiral contrac:.tao"ns of the stomacl~ ~~-id, in general, tlie z~~ovezrients of tbe patient indtice distal member 34 to enter t:lie, pyloric part of the gastro-intestinal tract iiriti the tioodi`nunia while i.-~roxit~ial met~~ber 32 is retaizietl in the stomach and. cannot nic~~~e beyond the pyto:ric valve be~~~~se, its diameter is l'ir4.~e:r than tile py-Ioric Vwilve oponing.
1.0 I:0061~ N40re paÃ-Ãicularly, proximal Ã~iembei' 32 ixiclu~~s a fiinst occl-LidiÃi;A z3ieÃltbez- 38, disposed il3 a ;oi1tTal po51t1oI3 within an api't?l3 In"L'T3iber 40. FiTst occluding It`1e133bei' 38 T3-laF%
be. formed 1`Toi:~i an elongated, narrower c011fiigUrati.on as shown in Fl.Ci, 1A to a cont-~actedry wider e~~~~fiL,uration as sliown in FIG, lB. In t:lie, eniLiodiniciit illttstrated. in FiG, l A, first ocLl dim~x member 38 has a helical design with a plurality o1'tiirny 42, ~.~~hiel~ are config red I;> to nest ~~ie, ai:-l;jacont to the c?tlier to assume the compact, btilboiis shape illiistm, te~:-l in FIG.
1:I3.
(00621 Aproii tziember 40 wraps arOLÃttd first occluding s~ilember 38, providing proximal member 32 with a enlarged diameter and pr~~~eritin:;s the passage of proxirsial iiiember 322 t[irotigli t[ie pyloric valve. In one variant of the present embo~:-limetit; apron 20 mers~ber 40 includes arY essentially cylindrical proximal porticg~i 44 coniiectetl to an essentially conical distal portion 46 that extends from tether 36 to proximal portion 44.
-I'his configuration of apron iiiember 40 is designed to provide an intermitÃelit: plugging ef'#'ect on the py(orÃc va1-ve and to avoid or anyways minimize abrasive coritaet with the wall of the pylorfc valve during such pIu<xg'iig c'ttc'ct, so to preve:iit or ininim'ze patient ~5 discomfort ~i-id irritations or even laee.raÃiotis to the mucosa o1'the stornacl~ and, .in general, to tlie gastro-intestinal tract:.
100631 Distal portion 46 rnay have a smaller wall thickness than i-.)r-c?ximal portion 44, botli p:rovidin4~ a gentler, ~u lypler cantact: with. the pyloric valve, and also :l`icilitating the reversal of aprrgii member 44 citir:ing insertion into a patient's stomach fi-om a position 3) 0 substantially ali;.~n~d with tetlier 36 to t:l~e, pc?sitioti that wraps around first occluding ~~~e-mber :38, as explained in greater detail below.
[00641 In d.iff~~~~ent variatiÃ:s of the present emliociim~iit, apron menaber 40 irlcty extend proximally for various 1~~igtlis, stirroiitidi~ig first ocoltidir~~ iiiember 38 partially or complc:t:cly. Further, i.r:t d.iflereni variants of the present erilbodi~~~eiit, alaroii member 40 niav be spaced t:rot:zt first occluding r~~~triber 38' at various diqances to create az3 interstic~
48 of clii`tereiYt aanplittides 1=y?et\s~een first os;,cltidit3g member 38 ant1 apron 1-liers~ber 40.
(00651 Second occluding ~~~ember 34 rnay exhabit a variety o1'eotiÃours and in general, is shaped to fiacilitate, its transition otit of t.lie, stoziiacl~ and into the diiod~~~um, and to avoid or nun:imi.~e abrasive e~~i-itact with the walls of the stomach and of the pyIoriis. lil oiie enibodiment:, sect~ti~:-~ occluding z~~ember 34 has a biilbous shape, esseiitiallv f'c?rmed by t'~vo rotinded, &usto-s;on.icai portioris 50 c:otiriec:t:otl at their witler bases.
100661 Device 30 may be manufactured from a variety oi'~~iaterials, for e.~aniple, from a resilient plastie, stich as a silicone or urethane lalststic, which may be roinforced in selected 1.0 partic ns. I~~ general, t;[ic selected material should be biocoiiipatibfe, re5ism, ilt to the st~~rnach envirtlnt-nent, t~~r ex~~rnple to stor~~ach acitls, and soft tc? the contact with the st:caniach and dtiotieiial walls. The desired material sIaoul.d also provide device 30 with the desire-d shape wliile retaiiiirlg sufficierit flexibility for tizo insertion proc-ess in the stoniaciz, for later reverting to the desired position wiÃ:i7.in the gastro-rntest.inal tract, ~iid t.'tir adapt.rng to t:l~e, variotis mt~~~~rnents of the stomacl~ and., in generaI, of the body of the patient.
100671 hiseris i:ncxy be integrally iiicl-Licieel w:itt-da the bo(lv of device 30 to increase ~ertaiii niec17anicaI properties iii certain areas. For exai-iiple; ~ii ii-isert (slicla as a nietall.Ãc cylinder) tz~ay be embedded withii-i second occltidi~g mers~ber 34 to increase weight and to ~acilitate retention bv gravit~, within t:lie, pylorus. Another itisert (stich as a f'abric. piece) may- also be. er.1~.:ibedcleti in proximal crY~.~ 52 of first occ(L3ti_ir.~g mer.1~.:~ber 38, increasing resistance to tear wlieii prois.imal end 52 is pulled outwards to extend first ocoltldin~
member to the configuration of FItwi. 1, or inwards to stabilize first occlttdiii,.y z~~ember in its contracted, wider conf-i-.uratÃoii, as explained in a.reater detail below.
[t70681 The insertion ot tlevic~c 30 in a patie.tit's stomach will now be describc..d wit1i ?5 re:1`~~enee to FIC_i. 1(_". tt shoLilri be noted thaà FIG. IC i[lrrstrates, among oÃ:i7ez things, olie variant of the embodiment of FiG;5. IA and iB, iii which a stabilizing cap 54 is added to maintain first c3cciudin;= rn~.~anber- 38 111 the contracted, wider conffis::ur-ation, and also #-o increase bulk itid to prevent die ititrotlliction of food or other gistric protllicts wit:h:iii interstic~.~ 48.
-30 100691 in t~tie ziietbo~:-~ of use, ~.-leti=ice, 30 is introduced in a patierit's stomacll in tbe elongated, narrower configuration of F[G. lA;witit apron z~~ember 40 ori~tited in tbe opposite direction to that sliowii in 1''IC. 1A, thaà is, to cover tether 36 wIiile the free ettd of distal portion 46 is orietited prc?xinially, iti tbe directioii of second occluding ~~~ember 34.
Wheii in tl:ris configuration, device 30 is disposed withHi a tiibe (iaot shown) kiiid is ca~~sed to ex:ittlie Ãttl~~ ~%vit}.t proximal eiad 52 first, 1"`oI1ow-ed by t:lie rest of the r.Ievice. When ~~~-,-4ce 30 has partially exited the ttil.`~e (or alternatively, the t[tl=,ie 13as beesY retra~:~ted from cievie.e 301) so tc) leave aprc~ii member 40 outside ol='the tube, device 30 is p [ledinside t[ie iLibe, but becatise aprort znember 40 surrotinds atid wraps around the ond. of'tbe tLibe, sticb a pulling of device 30 itiovards inÃo the tube, causing al3rot7 member 40 to flip over ~lid cha~ige orientat:~~t.i: so to wrap around. first occlu~in,.y meziiber '38. After s~~~~
a flipping arotiiid of ~iproii. member 40 has k?e~~~ achievetl.a tlevic:e 30 is completely i~iocted ftoiii the ttxbo a.sid becomes disposed in tlie stomaeb. Alternatively, device 30 may be i:liÃrc~duced in a patient's stomach with apron mer.1iber 40 already orientud proximally, r.listking t.tiir:fec~~sa ny 1.0 the previously described flipping operatiott.
[00701 While the cosi#.iguratic?n of fis-st occluding g~~ern~~er 38 mak~.`s., it recoil and assuine the contracted configttration, sii-iiilar to tkaà shown in FICi. 1B, the 1`lilly cont-i-acÃed, wider configuratioii of first occluding meniber 318' is achieved and maintained as follows.
A connecting member 56 is colilaleccl (for exam13le. by a first string) to a release member 58.
I;> A sect~tid string 60 is looped around device 330: running outside and along device 30 starcii-i~~ fÃ~~~r~a a first tree e~:~ci_ ~,~r:~~i then extending -o~ritl~zi.i~. connecting r~ae.~~~t~er 56 through .. .
lumen 66, ~iid t17et7 (within a lu.riiet7 or a t~~~~l wiÃh.ii7 iLimy 42, successively entering a lumen 62 i:n. tether 36 iinil second oc:c lUdit~~ i-nember 34 (see also FIG-S.
1 D and. 1E), and eventually exiting device 3~.~ widi a secotid free end.
20 100711 After device 30 has beeii i.ntrculuc:ed in t(xu stcgmae.h, a clinician can bold both etids of sect~ti~:-l strinLy 60 and, bv pulling oti sec~ond. string 60 wliile devic-e 30 is c~onstraine~:~
witbin tbe st~~~~ach, the clinician causes connecting meniber 56 to travel in t:lie, direction ol:-naat:ing cavity 64õ shaped st) to constrain connecÃi~~~ member 56 (Bor example, by ivtL r#Qrence fit) and to prevei-ià coniieeÃi~ig meÃiil~~e:r 56 ftam beÃn<_x re.leet:sed. Tl~erefare, first ~5 occluding ~~~~ember 38 is locked it7to its cotiÃraLted, wider eotid.ition c~~~ ~~~~~~~~~i-iei-it basis.
100721 After device 30 bas beeii shaped as described; second string 6~.~ is removed bv pLilli~ig on ~~iie free ~~id and br, havi7:-gs; c~~iid string 60 slicle through the l.un$on; withirl device :30; evetitually exiting device 30 entirely. Device 30 is now free to move freely within the stfgn7.aC:}3q a3~Id the natural cfg3~Itm cC1.oTis of the stomach, in addition to any other ~0 movements of tl~o patient's 1~~dy; cause distal ~~~ember 34 to move iiito the pylonis, wbile the size of proximal member 32 preti=eiits it from moving into tl~o pylortis and forces it to reside in tl:ie stomach. "I'1:wrefore, distal tneui1~~~~ 34 will eventually be disposed in the pylorus, and any iiiserts of a heavier weight will f'acilitate, retention of distal meiiiber 34 in the pylortis, while proximal men:ibc:r 32 will. act as an int:ermittenà platg, against Ã1io py1or.ic va1ve, bec.at~~~ stornaÃ.h contractions and other body moveinents will 4aLise prox:itnal i3:1embe1' 32 to move towards a:lYd away from the p loi'1C. va.l~ve, acting as an ]i3teI't'n#ttk'.ttt plug and allowing the passage ot: sotne food from time to t.ime.
100731 Atic?tl~er embodiment is illiistm, te~:-1 in t[ie cross-sectional side view of FIG. 2A
~iid the top ~iid bottoi-ii etid views, resl~ectivelN, of FIGS. 2I3 atirl 2C.
tn this emborii~~~~i-it, device 31 may also inclttd~ a distal meniber 33 connected or attached via tetber 3-i to proxi-iiiiil meniber 37. As tiesc.ribed abc?ve, proxitiia1 iiiert~~ber 37 may comprise azi ap~~~~~~
~~ie-m6er 39 whic-h defiiies a ctarved or nt:heiivise arcuatesurl'ace whieb tapers radially from tether 35 at a distal portion l l. (which typically contacts the stor.1~.:~aclx interi.or sL3rface when 1.0 iÃi use) to a cLirveti: proximal portion 43 wliic1a has a relatively larger diaiiteteÃ- aÃ~d which rnay define a circuanfere7:-gtial lip or edge 53 which is atraun$atic #-t3 surrounding ti,sU~.~.
Apron member 39 may define a c:harine[ or interstice 45 within w:[lic1.7 first occl~idiilt) member 47 iiiay reside wizeri occludirig member 47 is in its contracted deployment con~`igrrz-aiion., as illrisÃ-raierl. Watla ocelridir~~~ ~~~~ember 47 contracted, alarc~~~ ~~~~ember 47 rnay I;> be configured to entirely or at least partially ~~icircle or ~~iclose occluding member 47, as illustrated in 1`ICiS. ?D and ''E wIiich respeLt::i-yelz show side atid cross-sectional perspective views. Moreover, i.tiÃersÃice 47 may be left ul~en when in riye in the laati~irt body or iin atldition.al cap i-netziber or c:Egvering may be optionally iittacl~ed to t%tl.ly enclose apr~~i mcziil~~~ 39 and occluding z~~ember 47 witliiii, if so desired.
20 100741 Oc:cl~iding t1~.:~ember 47 tnsty be forinetl iiito a coiled or wcgatnci structure having a plurality of tLirns an~.~ a distal ~~~d which is attacbed, coupled, or othen'v--i~~ ~orme~:~
integrally witli device 31 at connecting lsc?rtioii 49. Because of its coiled or wotiiid helical Strtic tUte, OCC( dÃzrw member 47 may be ext~i-icled in a low-pro#ile confl~.~pution, as above, for deli~'ery ii-iÃÃ~~ the paticiit body ai-itl tlie~-i allowed to compress or coritract iiito its coiled 25 structure whacla forms a diz-it-iieÃer or crossrcsecÃ:i~~i-ial area whicla is relatively larger tl~~~ii a diameter of distal member 33 to iiihibit: or prevent the passage of proximal member 37 throu~l~ the py1os-zts when in t~se. As in the afc?rerriesitic?ni ~rnbodirrient, occluding tiietiiber 47 t~iav be biased or cotifigtrred to selt-cont:rict.
Alter~iativelv, a string member or other locking tziec(xanism, as described herein, may, b~.~ Utt3at~.stl to compress and:or lock the 33 0 structure such that the expatided configuration is maintained ~~id prevented from releasing atid recoiitigtiriii4.y back itito its low=profile, configuration. Distal member :3:.~ may 1=~irther ciefirze a 1tir-zieii or chatitiel 51 to facilitate the plaL~~~~~i-it iand;~'or positiÃznin=;f of device 31 within tl~o patient body.

[00751 In yet another embodiment; the Ã:f4e.ltidirig ta~~enibe.Ã may be fabricated tis a scparate c~~~~~~~i-e:ti.t arid attached o-t- c:c?tip1ed witi-iiiY the aprEgri member at a later tinic rtither Ã17ali t:orrnim~x t[ie oLclud.i~~g member as a continuous integral Lornporzent. '['his partictilar embodiment allows for the size, and shape of the oc-cludin(y mertiber to be varied and alto-red :? according Ão aiiv patient-speLific parameters aiiccl attacl7~d within a Loninion apron member.
As shown in the side view of FIG. 3A an~:~ the cross-sectional side view of FIG. :.~13, occludint* member 61 aZ~~try be f:E}rtiied as a coiled or wcltizid hi`li.cal structure which defines a c-lianziel 65 aiid a rec-eivi~ig portion 63 whon in its collapsed deployed configuration. As previcgatsly described, occltittiiig member 61 may, be advanced into the pati.ent botly in an l.{.~ extextcled low-profile con~'ig.uratioÃ-t aitd tlieii eoll~~~~ed iiito its ~xpaxtcled and optionaliv locked conf.igura#it?rt, as shc~~vn, either via actuation or by allowing for sil.#'-reconfiguratit3D.
[00761 Because the coiled portion of occluding member 61 ~~~iay t:i~~~~~~~ a receiving ptarÃioii 6-3 in its collapsed c-oiifiguratioii, ptarÃioii 63 may 6e c~oupled to a complementary 5ecirrenaent meclaz-itiism laositiorzeil watlai.ii aprorz member 37. In this exariiple, the 15 soc~~~~~~~~ent ~~echariisni z~~ay be comprised of a cotiz~ectiii4.y portion 55 which extends distally witl:iiii ap.rof-i naember 3.". Connecting portion 55 naa;~~ lizive a securetvient ~~~eti-lber 57, ~~ich as a tapered portion, and a stop member 59 which each limit the rnovenient ol=_ t.-~ -ortion 63 relative to connecting porti.Egri 55, 100771 As illustrated in the cross-sectional side view of F1G. :aC, occluding iiieniber 61 20 is showii in its collapse~.1 and 1oc:ke~.1 confi.guration ivlii1e secttrecl wit}aiÃi iw'.L rw.ic~.Y 45 alid encircted by apron member 37. As shown, ~~curement member 57 may 1~e, advanced at le-ast partially witlii~i c[i~tinel 65 t:ortned by the wotin~ occludititw iiiember 61 to prevent t:lie, relative moverzieiit or release of occ:luciinc~ member 61 from co~~i-iectÃzrw portic~ii 55. The connecting portion 55 is illustrated a.s ari example and is iiÃ~~t inteiided to be limiting. Other ~5 k_nown secLiremei-zt mec:.baii.i~~~~~s may be titilized as practicable.
100781 in tk~~~~ and otber embodi~~~onts described herein, l~ecatise the devic~~ may be introduced iiitc3 the pation# body in a m.imtna11y invasive rnanner-, e.g., por-orally and through tlle esopha4~~.is :itito the patietit's stomach, the device may be delivered in its, low-profile conti{Furzztion. ~.~.g,, wher~.s the occluding mer~~ber is in its uncoiled or unwound '30 elongate c~onfiiguration. Alternatively, tbe device ~~av be delivered in a partially locked contiguration. C~~ice within the stomach: for instance, the ~evice may be coiled or wc?trti~:-l into its cteploznienÃ: con.figaration af-ici the occluding i-tiember may be ati-irr-natively locked into pt?sitiaii relative to tbe devic~~ stich that its enlarged profile nibibits or provents the pa~~agc of the device Ãhrougla the pylorl.is. Iii ensur.iiig tl:iaà the occlutli.n;~ ~~icrr~ber .is locked into its expanded configuration, ~~aris,3us tner:.hazusms mtiv be Litilized to c.ontarna its sc CUMIICrIt.
(00791 Ot7~ exanaple i~iclLides having the sirisa: for locking the occluding member be color-coded siich that one portit~ti of the string is of a different color, e 4,õ., red.. than ttao renaa:itider otthe stri.ntj. As the sÃrim, is ten5:iot7ed to lock the occIudim, metziber, ot7ce the color-coded pcartit?ii is exposed from tbe device, the tiser ~~~av visually c-olifiirzii that the occludi.no tiaeiaalaer is locked into its deployrt~~ent configuration.
Alternatively, the amount of tension required to lock the device may be calibrated to increase to a preset level otace t(au device is locked such that the tiser may c.onfim-~ by tactile feedback that the device is 1.0 i Ãa~~ed locked.
[00801 Other aitemative mechanisms for locking ct3nfirrnat.ion or c10tectic?n of the occludi.na device inay additiorral[v inclttclc s~~isors incorporated within the device. An example is illusÃrated in the cross-sectional sic~e, view of FIG. IF, wliich shows sensor 67 positi~~i-ied >it[iiii the rlevice. Sensor 67 may incorporaÃe at7~~ i-itimber of detection modalit:iesz e.(Y., acoustic, ultrasonic, electrical, electromagnetic, optical (for instance, deteLt:in ; chanaes if-i color, wave1en4.~tla, f:~-eziiiciic~. eic.), ~;l~er-zai~:~l, eic~. which may ;~e.~~.se c17atiges in the occluding mei-ii[aer from its coiled deploNl-irieni configuration or changes M
tlat str:ing, tension, connecting rsaernlaer.56, or release mem.btr 58.
100811 Based oii the toregoing, device 30 (and variations tla.ereof) assists in the treatment of cgbesitv by limitin9 the passage of food from the stotl.:fac(a into the intestine, atad at the sanae. tiziie by reducing t:lae, intake of tood by t[ie patient diie to tlao sense of fullness generated by the retention of food in the stomach for a longer tiiaae, and also by to the presezice of device 30 i11 the Rtornach, [00821 Experinaeiats pc:rf~.~rnaed with tlto above-described embodiments indicate a 2 5 :::dose-respotise" relaÃiotis_[lip betweei-i the tlaickiiess of the wall of distal portion 46 ca.tid ~~~igt loss of the pat~ent:. For example, a series of experiments performed on do,an~
surnt-riariz~.~ti in FIG. 4 itidicdrt~.~ that the greater the thickness of the wall of distal portion 46, the greater the rate of weight loss.
100831 In rg~~~~ version of the present ~~nbotlitnent, apron inen-iber 40 has a total l~.stagt(a 3 0 of 38 iiim, witla t:lae, proximal (cylindrical) portion laavitatw a leng-th of 15 zaim and an outer diameter of 53 mziiz and the distal (conical) portion having a lezagth of 23 zaim. 'I`k~e first ocLludÃzaa member 38 hias. in its contracted configuration, botl:i a length and a wi(lih of 35 iiim, while distal ziiember 34 has a leii(yÃb ot " ? 5 mzn and a diameter of 15 inni, widi device havi.ng a total 1~i-i~;ih of 14"? mm. hi th.is version, the wall of the ciistal portior:t 46 of aprot~ ineri-iE~er 40 may have a thickness of 13 mrn for a ta-mximum rti;i~ of weight loss, of 0.9 rnin for a r~ieditim. rate ol'weight loss, tirid of 0.5 mrsi for a lower rtite. ot'wed~.Yh~ iosis.
(00841 After device 30 laas- achieved its tlesi.rerl resiilÃ:, or whei-i it becotzi~s de:,irable to reznc~~~e device 30 for any reasons, different removal options are available to a cIiiii~iati.
Ã?~~~ removal option is siirgic:.a1 removal, for examl3le, lal3aro5cup:ie~
surgical removal.
Another option involves rez~~oval through the esophagus and tbe tliroat: by causing first occludino meniber 38 to reverse ii-om its corttr-actitla witler- con:{-:gL3ration to its e1osigated, narrower configuration. To achieve 5tich change of configuration, proxinial end 52 of first occ(L3d_ing r.1~.:~em.~~~~ 38 mtist bocor.1ie tlisenga;Fetl from connecting member 56, which is also 1.0 engaged in cavity 64. As previotisly described, connecting Ã~iember 56 is cotip1ed (for ~xarriisle, with the first string) to re1~.~as~.~ tnen$1~er 58, making it possible to disengage proximal end 52 1`roin cc~~inecting member 56 by ~eve.riiig the coupling (for e:.tianzple, the first striiit#} beÃ~~~~~i cuiuiecting iiieiiilrser 56 ~id release member 5S.
This c-an be achieved through a proced re perto.rnied by introducing art appropriate sLirgic:.al catheter (as kiiowti I;> to a person skilled in the art) in t:lie, stoziiacb of the pationt through the esophagus, with the as;~i,siance of a~~ endoscope, by severi~-ig the coupling betweeii connecting ivieÃ-tiI~er 56 criid release member 58, and bv siieceasivelv removint.~ device 30 through the eaoplaaglly.
100851 While the p:rosesYt embodiment hcis ~~~i-i described in re1ati.Egi-i to obesitv treatments, it mttst ~~e, noted that treatments of other ailznents throulgh device ~0 are, also 20 possible. Examples of sLacl:f treatments inch3de treatments to restore nor~ial ;Flu~~se tolerance to a diabetic or prediabetic sub~joct, or to delay or pr~~ ent the progression of diabotes in a subject, by inhibiting 1`asting insulin secretion or glucose-stimulated insulin seeretÃnzi. Other examples of such treatments. include the treatrr~ents of patiezits su.fter.ing f'rom ~~ie or morc.. diseases characterized by obesity including hyperpl~agia, dyslipidemia, ~5 Prader W.illi a;~iidrome, Froelich's s~ndrome, C'o1~en a;~iidrome, Silriim.it SN-i7drome, Alstroz~~ syiidrome, Borjesen syndrome, 13ard.et-Biedl syn~:~lrome, and hyperlipoproteinemia, types I. ll, II:f, and IV.
[00861 In ditTeretit variants of the present embodimejit, various ancillary ~ompc~~~ents may~ be included, ,atch as sensors, miniature tnotcars, or r~~sert:~oirs. In ~.~~-ie varhint, a serisor ~~ may be placed in litio witb t[ie lockin~ st~~i~~~. tt? prt~~~ide feedback inft~rz~~atit~~~ about tl~e trtiexlaect~d unlocking of the first oeclu~.-ling, meznber frozn its contracted configuration, indicating a fa.i1rFre of the locki.ng meihanisr-zi. In anot.l~er var-iaiit:, a miniature ecceiitric Z~~
iiiotor ~~av be i~ioltided tbat generates a vibrati~ig ~onsat:~on, for example, when a patient ni-est.s aia excessive amt~iint of fooel. <~~id food in excess of a predetermined threshold li<is aceu.nmI:it~-A towards the pyIox.=:c va1~~e. In still atiother ~r~rit~~rt. a reservoir ccslitaitling a thffai.~eWiC sUb,tance may b~.~ inc3z7cled that releases that substance over tinic, or areservoia' of a mi[dlv irritat.ing substance, that may be Ã:~rnporari1y opei-ied for release .inÃo the stomach wben a sensor perceives the ingestion of ati tiiidesired substance, such as sugar: so :? to gerze.raÃ:e an ~~~rpleasani reactiorz in the patient at7d break the 1~abit of ingesting tlie tiiidesired substance. "f}ie motor or the reservoir may be refilled with po~~~er, and:'or the reservoir may be refilled with the desired ;til=,astiirtc:e, through a catlieter iritrod~iced in t~ic esophagus azid. i:tiÃo ttie stomach or in tl-ie case of the motor, ttirt~ugb teleznetric ene:r4.~y t(<iiEsn3ksJio3l. Communication devices, data receivers, data .?tV'l<ige modules, 1.0 microprocessors and rechargeable power sources also Ãiiay be included in device 30. A
ther-apetitic substance ~~iay a1;c1 be in$pre;=nat~.~fi into the walls of device 30 to b ~.~ eluted over (0087] A-ZUtizer embodiment of the present invention is depicted in FIG. :?.
'fho, 6asic.
components of device 68 include a proximal rziember 70, a ieÃ:t7er 72 at7d a dista1 tziember 15 (iiot: sliown,) at t:l~~ end. of Ãetber 72 opposite to proxiziial member 70. Parts of this embodiment af-ici of the eÃ-nbodirnenÃ~s described hereinafter are comumcazi witl:i the p.reviouslz described emboccli~~~~i-iÃs, and will i-ioà be described again here for the sake ol:-brevi.t.y.
100881 Proximal member 70 includes apron member 74, w1~ie1i. surrounds first 20 occludim-x member 76 and. which is composeci of zi proximal, cylindrically shaped portiotx 80 a~id of a distal, conically-shaped portion 78 that cotiz~ects prc?xinial portit~ti 80 to totber 72. First occluding ~~~ember 76 iticttides a support ~~~ember that exteiids from the tip of distal pnrtior-i 78 (wh:icl:~ corresponds to flie proximal end o#'tetl:~er 7:2) :ii-ito the inner portion of apron mciiibe.r 74, and a cup-shaped me:iii~.~er 84 that is connected to suppoi t member 82 2 5 approximately midway a~id that has a cot7cavity facing proximally, with cup-shaped ~~ie-iiiber 84 being joiiied to stipport ~~~ember 82 by first joiiit 86. In ttiril. siipport z~~~rnber 82 is joineci: to the distal end o#'dista:l portion 78 (which corresponds to tl~c proxima1. end of tetller 72} by second joint 88.
100891 FTG. i illustrates t:(xc e1otYp ted, narrower c.c4nfigoration of cievic~.~ 68 prior to 3 0 introduction in the st~~~~ach or other organ of a pat~ent. In this elongated, narrower contigtirat:~~t.i: device 68 has apron member 74 or~~tited distally (towards the sect~ti~:-l occluding i-tiember), which requires that aprott ~~~etviber 74 be reversed to change orientation and to t~ecc~~~ie, directed proximally, as shown in FIG. 5 and as described in relation to e.rubÃfdii-r~ent 30. Alterna.tivelz, aproF-i ta~~eni:1~er 74 niay be or.ienterl proximally even duririg introduction into the sto-mat,h of the pat~~~l-it.
(00901 After introduction in the stomach, li.rst occluding ~~~~emb)er 76 is caused to assiime a ct~tiÃracted, wider ct~til~'taration t~~~~u'a[l ttie tise of a st:ring, as described in relati~~i-i to emboilii-iiet7t 30, that r iis ouÃ5ide of device 68 then through first ring 90 on al7 edge of cup-shaped member 84 and ftirt[ier t:lirc?tt(.yh sect~ti~:-1 ringy 92 at a lsroxinial ext.romitl=
of suppE}rt r~~~rnber 82, and still forther through a lumen withiz~ tether '12 azid. within tlle second occluding member. By pulling on the free eiids of Ãhat string, support member S2 is ~~~~se~.1 to arch in the direction of second joint 88, acqt.tiriiig arY~.l essentially closed shape, 1.0 and ctip-shal~ed Ãitember 84 is eatised to flip around, reversing orientation and overIavi~ig the essentially closed shap~.~ of s~ipport n$emb~.~r 82.
[0091] `G'here1=ore, :fiirsà c~CClittliiig ~~~~~~~~iber 76 is cat:i5ed to acquire a coi~~~~x-, [ayereil strÃicture, wit:li tlzo cusp oriented proximally. As in embodiment :+0, se-eond ring 92 or a conneLÃ.i~~~ member are catised to en;.gage a c~aviÃv or other structure in the area of yecotid joitià 88, becozning , pernianetit:ly eny~aged. Also as in embodimetit 30, removal of device 68 frc~rn the stoÃ-nach may be achieved tltrÃzwd:~ surt.~ical intervention, or a1terttafive:Iv through ttie esophagus by causing device 68 to revert tc) ttie narrower, elc~~~~ateccl LonfigUration by ;?everlllo ci string or other Y't'ti7.1:1i4.'`t that connects tl]<'.
4=i)Y]Y3t'4I1lYE,~ member to a rel't'iisC.' iiiember, .
100921 A third ers~boclimunt of the rnverYtion is depicted in FIGS. 6A-6B, FIG. 7antl FICi. 8. Device 94 i~icludes, as in tlio previ~~~~ embodiments; a proximal member 96 and. a disÃal member 98 connected by a to-ther 10~.~. In device 94, first occluding mezilber 102 inc( des a plurality Of sÃ-r ts :104, tl:iaà may be #:orr.nerl as indÃv.id al sÃrtits connecting the proximal and distal eÃids of first occluding mciiiber I02, in the fashÃoii ol'tlle ribs afa cagc,.
~5 or Ãhat may be t:ormeccl as sheets ea.tend.ing fi-om ttie longitudinal axis of t:irsi occluding member 102. in the fashion of pages ofa book. In one version of device 94, struts 104 are nianufactured #'ror~-1 "a silicc?T~~ rnateria.l, that is bioÃ:ompatit?le and that c'an withstand the gastric efiv:irozimefit. A silicone material ilso can i1so enable changes ol'curvature rangÃng between th~.s elongated, narrower configuration of FICY. 8, t'lle intermediate configuration of 3 0 FICi. 7, and tbe contracted, wider configuration of FiG. 6A. Like in the previous embodiments, first occluding member 1022 is structured to be, inserted in, and removed f~C?I3:t, i3:Ii i).t'`.:.,fa.ti slich as the StC3ixitii::b w1.1L3i it .is ci)nfigtll'Cd ]Il l'l1e ClC)1'1:gt1ted, l:itil'1`ower configuration of FIG. 8 atid atle-r it has beeti placed in the stomach or otlier or;.yaii, to be rec.oi~.f:~gured into the contracted, wider confi;~,*uration of F1G. 6:'i, This change of contigunation. is achieved by hav-i.rig a st-rir~-ig 106 disposed around and tl~aroLigl~ ~~~-,-4ce 94, 111 partictilar, through first occludiriÃ~ inemly?er 10.2 and through 1t3~~~eris isY tether 100 and. in distal member 98. Alternatively, st-ringy 1{)6 maNf be ew.mected Ãc) the proximal ~~id of t~.rsÃ
occltidin~ member 1.t.~2 and. run throug~:1~ lumens in tether 100 and. distal member 98. .~~~
laLilling orz string 106 when first ocLl dim~x member 102 is H7 the eIon4.~ated, narrower con~~guratit?n of FIG. 8, stnlts 104 are, catised to fleis. and to provide first occliidi~ig ~~~ember 1.02 witb tlic rotiritier configuration of FICY. 7 and then with t.lie. anore bulbous coni-igoration of FIG. 611.. The configuration of first occluding member 102 shown in 1 lG.
6A is maintairYUd thanks to a e.on_rYUcxim-, member (not showii) t(xat provides for a secure coL3p(ir:fg 1.0 betweeÃ-t the proximal at~d distal ends of first oec::[udiniw meniber 102.
~00931 Conversely, tc.) revert fi-oni. the conlis;airation of FIG. 6A to that of FIG. 8, a retainer tstrch as a string) cotipliilt) tl~~e connecting member with a release meinl~er 108 is severed, in a maiu1er similar to that described in relation to the previous ernbudirnents. In ww variant of t[ie preseiit embodiment, stri.tig 106 carries ~iiltmber ot.' spheres 110 or attachments of other shapes that tratislate through an area havi~ig walls where interference is presciit betweensucl:i spheres 110 aiid those wa11s. ~~~ich iiiterfer~~i-ice is overcotne by the force applied tc) string 106 >1~~i-i it .Ãs piillecl, biit ~.~~1~~~ii such force is not lar~~~i-it, the interference is sLif~:icient to block the tr~i-islatie~~i. of strinE,~ 1.Ã36 4sritl ,tabilize the configuration of first oceliidi~ig mertiber 102. In other variants of the present enibc?diz~~ent, spheres t 10 on string 106 en;-xst;.>e orYU or t1iore mating locking tl.ei ic:es, for etiwtmplu, one or more, of iiiati~ig locking devices 1.07, 109, or 111 disposed in a IongitLi~:-litia[ lumen through device 94 prc?xinially, in the zniddle, or distally of tetlier 100.
[00941 Oiie skilleci i.n the art will appreciate that struts 104 rnay be manuCactUred from a variety of materials, including metallic ancl. plastic materials, for example, silicones and 2 5 shape iiaemo.ry. materials. (?iie skilled in the art will further appreciate Ã17aà the materials may be izn-pregnat~d with a tberapeutic rnateriaI that is released in f1ie stomach and./or f:a:itTt?-1T1te5t123al tTact t?4 "L'.r t1T3-ie, and that a11G1l1.'c7t'\%
cS1Tnpt?#1"L'.Ftts, such feedback and radIo transmitters or re'servoir's of therapeutic t~iaterials, may also be included in device 94, as described with respect to the iirst embodiment.
-30 1 909--s ] FIG. 6B depicts a variant of the prese-tit einbodir~~ent; in whic-kt first occluding member 103 inclttdes otiter surface 105 (in the l;ashioti of a skiii) that provides a sziioother sLarfzice to the -asÃ-ric mticosa.
100961 A totirth eznbodiz~~ont of the invention is illustrated in FIG. 9. A
key clifterence betAvcei.~ device l:t 2 of the tiourtla embod.imc:r:tt ~i-ici the preyiou5(y described embod:imc:nts is that first occluding member 114 is- shaped iike a hollow ball haz:ing, a pluraliÃy ot"openirags 1. iti, so that it ciiri be contracted to provide 4iri clongatet1, narrower configuration sLiiiable ttir insertion and ~emova[ of device 112 .inÃo anccl from the stomach of a patient, or can be expanded laterally by pulling on a string running longitudinally through first occluili.ng naember 114, tether 118 at7t1 seLorzd occluiting naember 120, so to provide first occluding member 14 wit[i a cotiÃm, oted, wider configuration_ 100971 Orte skilled in the art will appreciate that first occluding anem1.3er l 14.may have a variety of oÃber sbapes equally appropriate for the interid.ed. purpose, for exanilsle, an ellipsoid shape, and that openings 116 also may- have a variety of shapes, for exat1.:fla1e, 1.0 hexagonal (as shown), polyg.c naI, round or ova[.
[00981 FIG. IOA depicts a fif'tli. ~.~tnl:?c?tiit~~ie7:-gt of the invention.
Device 118 is represciited wily in its prooi~~~ial porÃioti, whi.cb includes apron i-iiember 120, tirst. occluding rne~~.~6er 122 ~~id the proximal laortioii of t:ether 124. First oeclutli~~~ 1-1z0.1i-1ber 122 is il[tisÃrated in greater detail in FIG. 1[3t3 and has aii essentially semispberical oiiÃer surface 124, directed proximally (away trom t[ie pyloric. valve, after iiistaIlaÃion in the stoziiacb fand a plurality of ;trttts 1-26 that r-z-ia, be s1:ia1~ed as i.iiciividiia:I rods like the spok~s of aii u.riibrella, or as sheets, like the ski.tis of slices withi~-i aii orat7~~e or the blades of a roiary~ ~ari.
One of the advantages of the present embodiment is the very smooth surface presentetl by oiiter surface 124 to t:lie, 4.yastric mticosa.
100991 ~.~'bile maintaining the (l~~scriptive similarity of first occ.ltitli~~g mer.1~.:~ber with an trmbrella, it will be noted. that first oco1tidin~ ~~~niber 1214 may be contracted to an elongated, narrower configuration in t:lie, f'asbit~~~ of a elosed. umbrella during insertion ol:-cievice 1.18 in the stomach or other nrwanõ and may expanded tc) aii ex,pazlded, wider eonfiguratÃoii in tlie fashion of an ope.~~i u:rnbrollet: after installation to perform its food 2 5 block.ing l`~~~iciion at Ãt7e pyloric valve. "['he transiÃion from the elongated, cotiÃ-racted state to the expanded, wider state and vice versa is achieved with t[ie use of a striii,.y or equivalent joining protitict, f:or exaa~~iple, ty4 havi.r:-gs; a string 128 ext~iiti #-hrorigh one or a-riclre loops 1:30 (or rings or like extensions) on oute.r sur~ace 1 ~'4, t:l~~~l witl~ both ends, through a. lunieti (iloÃ
sho~~~~~) dispos~.~kl in the axial direction of first occ1t3ding tzienib~.sr 122, and th~.siY into a '30 Iuznen wiÃbin tetl~er 12-4 that coiitinties within a second occludin4.~
~~~niber, in a manner similar to the previously described embodiments. Also like in the previotisly described eÃ-nbodiÃ-rienÃ:s, the wider, e.a.pc~iidecl configtira:tion of FIGS. l0Ar l 0B
tnaz be retained by providing act?~~tiect:ing znember that ent#ages a corresponding cavity after first occludiiitw nierrit3c:r :122 has beer-i fully exlaaiaded, :uiti the w.icier, expkiiided z.onfiwuratimi may bc:

re-,=erted to the narrower, elomwated configuration by severing i:lie connection between the connec:tin;s ii:ters~ber tiriti a release member coopled to tlxc t,onr~ecting, membc:t'.
(olool t=)tie skilled iti the art will appreciate that varioLis feaÃu.~~~~ ~-nay be added to tbe prese-rit embodiment to intlsroti=e usability, for example, tbe ent.t-y point of strin(y 128 into oiiÃer au.rfzice 124 may be f m.neI shaped. Other features may also be added like in the p~~ovious embodiments, for example, feedback and data tratt.smissic?~~
devices, or resenoirs for therapeutic or selectively irritating Subst<1n.s;es. Ftirtl~er, device 1 1~ i-iiiiy be manufactured from a varietv of materials includin4.~ a resilient plastic with localized reiiifoi-cemer:fts, or with a plastic or metal material admixed or coated with a tber~~pet.ttic:
1.0 substatt.c:e t[t.at clutes over tiz3ie.
[010:1 j FI.CfS. 1 I A-1 1B illt3strate a sixth embotlim:~.~nt of the iri4 eritiosi #h'at bears a iiit~~~iber of similarities to the previotrs embodinienÃ- bttt a[sca a few cliffereiiees, scai-iie of whichare described hereinafter. Referring first to FIG. I IA, device 1332 (illust:ratecl uiilv in its proximal portion) irzLl rl~s a 1-:azat occluili.tig member 134 that .includes (see V-1Ci. 11I:~) a I5 ceiitral htib 136 having a Iori,.~itiidirial 1~~~~on 154 therein, orie or mo.re struts 138, and optionally, a connecting mer-ziber 1.40 exteiicli.ng dÃstallz.froul htib 136..
101021 First occluili.tw mernber 1.34 mav or mav iroà .Ãnclud~ ~i-i oLiter S
rfa:ce 142, directed d-istall.v (towards the pyloric val.vtg witb its cusp ~i-itl proximally (towards the esopbagus) witb its open edige. As in the provious embodiiiient, struts 1:.~8 exteiid radially 20 from hub 136 and may be shaped like rc4cls, in the fasbion of wheels spc4kes, or like sheets, in t[t.e fashion of fan blades.
101031 Otiter surface I42 (or htib l3t.~ w}ien ortter surface 142 is not present) is con~~ecÃed to tl:~e iii.tier tip of the conical 1~ort-ion of apror-i r.nerzi(3e.r 144 by taFbtiiar rzlember 146 t1iat, in ~.~Ãie emb~.~tlime.tit; is c..sse:iiÃially cylindrical and Iias a lumei-i niiriii~ig ~5 [om~xitudinallv alorza its len(Ãh.
101041 Cott.nect:ing member 140 includes a rod portion 150 and a conical pt?rti.on 1 ?2, and secures first occltiti:inux t~~~s-ti1~er 134 in place by extending connecting ~~~ember 140 itito the lLint.eii of tubtrlar member 146, wh:icii 1~~s a diameter narrower thiii the diameter of the ba,~.s of conical portion 152. Therefore, conical portion 152 travels ~0 along tbe ltrmoil of tubiilar menil~er 146, eventually exiting it when pulled; for exanilsle by a string that is disposed arotind and otitside device 132, arid. theii through the ltiziiett. 1 ~4 of h-Lib 136, tbezi tbrotigh Ã:lte 1~~imcf-i of txabular member 146, and tbezi tbrotigh Ãlte 1~~imcf-i of tetl~er 148. The pulling action on the string ~atises first occludirtg znember 134 to expand i:rt~m an eIon-ated-narrt~wer configuration siiit,,tble.i:t~r.ii.itx'oc~~icti.~~i-i i.ii the stomach throw~;(l the esophagus to a wider expanded c;OtIlagfftltics~~ stfital31e 1:or xn ainta.in ing apron member 1.44 in a:ti. expanded position.
(01051 I3ecati5e conical portioti 152 bas a di~i-i-ieter narrower t[-ia.n.
tlie 1umeti of tubular meziiber 146, conical portion 152 is prevented from traveling backwards through the 1t~rneii of tiibtilar mei-iiber 146 ~~i-ice it has exited that l~imen, locking first oLclud:i~~~
~~~ember 134 in a wi~.-ler, expanded lst?sitioti. At the same time, in a manner like in the precedin~* ezn1.3odimesit. first occlatdino anen$1.3er 134 mav be reverted froan the widera expanded configuration to the ziarrower, elongated configuration by severi:tig a Iitik,, for example a sti-ing that couples connecting ~~ember 140 to a release r.1~.:~einbur (not showii), 1.0 t1-tereby unlocking. first oec;luclixtg tnember 134. Also li:[;.e iÃi t1~e preceding etn(aoditrtents, di.{terent types of bic?cclml:satibte and gastric-resistant rnaterial.s may be employed to manufiacture clovice 132, aiitl tli:tTirent optional accessories, stieli as feeil~ac:k aiitl data coiitrullers ~~~~ siibstaiic-e reservoirs, may be iiim:.lii.detl. fiitu tl.evice, 132.
[01061 C)tie of the advantages ol='t[ie presciit: etzil7oditzieiit: lies in the strtictu.re of I5 first occluding meniber 134, which oriables an easy chan,.~eover from the elongated ccan.lÃ,mra.tion to the expa~ided cc~~~figtiratic~iis aiid vice ~~~~~sia, and i.n Ã:lte distal orientation of t17e Liisp of outer surface 142 (wla~ii included), or in the shape and dispositic~~i of fi.rst Oc:ClDd:ix~~ ~-nerziber 134 \,viilYin. apron rsit~-nber 144, whiclx in.creases the occluding strentah of ~.-1evice, 1 32 against tlic pyloric valve.
20 101071 FIGS. 121A and 121=i tiepict a ~eveiit.h ers~boclirsterYt of the invention, in which a ~.-1evice, 156 again includes a p~~oximal member 158 connected to a distal member 160 bv a tether 1622. In tLirÃt, proxiziial member 158 includes an aprt~ti member 164 that S UrOUT-I&s strUt:', 1.66, which tziav be shaped as spokes (in the fashion oCuni13re lla spokes) of have a more extended, arched pe:rÃimte:r like longitudinal slices of a corie that encompasses ?5 aà least a porta~~~-i of the i.nner perimeter o1`aprc~ii member 164. More particularly, VIG. 12A
shows devic-e 156 witb struts 166 in ati op~ti posit:i~t.i; eaga;.~ed by a base 168 Ãsk~~~~ ti in FIG. 12A iii (ii-o positioti;, c3n~.~ as it approaches st-ruts 166 and the otb~.~r as it has cc?Titacteci:
and enLmoed strtits 166), wh:ici~ has a wider portioti 170 aiid an elongated portion 172.
Base 1 68 has an axial Ium~.'n, extetitliti{F at least tl~rc4ragh the. wider porGiolY 1 70r 3 0 dimensioned to ongage rod. 174 (FlG. lZ13 ) Ãhat extends proximallv from the distal ~~id o1=-, alsrori ~~~ember 164, at its conical tip, iiitc? the interior of proxillial member 1.58. As base 1 68 travels towards the ÃtiÃ:erior of proxitncil mer-ziber 158, in the direction of rod 174 ( I-'ICi.
1213), sÃi tiÃs 166 are fbrc-ed to diverg~ and provide lateral support to aprc~~i member 164, t1ierebv ~~10si~11-11 prommal n--temlaer 158 to transition from <~~i elon-aÃeci, n;irrower contigunation. 4liitable 1~zsr introduction into the stomach f-rom the esophagus or i1.1toariother o:tpgan, to a witler, exparitlet1 configuration ,tiitable for ot;cltidit3g the pyloric t<ii1ve. Base 168 is reta.i~~ed iti a position ~~~iated with rod 1 i4by beLorning .restrained by retainers 176, suitably angled to promote tbe moti=emeiit of base 168 towards rod. 174, and to restrain tbe translation of base 168 in the opposite tlirectic~ii.
101081 Like in tlio previoi-ls embodiments, proxiiiial ziiember 158 may Ãransitioti ti~~~i-ii tl~ie ~iarrower, elongated c:E}nfigur-at:ion to the witler-, expanded c:E}nfigatrat:ion.by pL311ing oti an efxl of a string (ziot s11owzi), which travels outside and aloii4.~
device 156 and ilito the lumens of base 168, rod 174, tetlier 1621 and di-m1 mer.1.:fber 1 W Base 168 may also 1.0 iÃ-tc;lucle, in its iÃiterior portion, a connecting member that engages a tnatittg eavit~,.~ (for ~xarrilsl.e, by ititer-ference fitl to rod .174, or t?4' othes-inuxagirriesit; known tc~ a pers~~ii s.,ki11etI
in the art.
(0109] Conversety, b~~e, member 168 may be disengaged from struts 166 by lary H-T struts 166 olaeti z-itiil by releasing base 168 from retainers 176.
If base 168 also is I;> retai~ie-d in place by a cc?~~tiecting member, the disengagement of base t68 to revert device 156 tc) the el~~~~gia#ed, narrower Lont"it.~uriatÃon ittvÃzlves the severing of a coupling (for ~~amlale, a at:r.Ãrig) beto~~~~ii t17e connecting ~~~~ember and a release ~~~~ember. .Ãn a mar~i-ier sirsliltir to th.at de~cribed. for the previous er~~bodimesYt.s,, Also as fEgr the ~~~~se:tit embodiments, device 156 may be. znanufiactured from a variety of materials that are, 20 biocor.1~.:~laatible, resistant to the gastric environment and that ti.~
~iot cstu~e, erosions. of the pyloric wa[l. Device 1.56 also may include tee~:-1bac:1b. or data transmission devices or reservoirs o1=-t:herapeutic or predetermined IrriÃating stibsÃatices .
Iai1ol 1"lCiS. l 3A-1 3B depict an eighth emlioclimeiit of the invention.
Device 178 incltttles a proximal n1e:rnl.~aer 180 and a. distal inc..mber 18~~?.;
caiiiiectetl by a tether 184, 2 5 as.iti the 1~~~evio s1y described enabodinients, btit does i-ioà izielLide a first occluding member witbin apron ~~~ember 186, contrary to the proviously d.o-scril~~~
enibod~~~~onts. Instead, apron meniber 146 isicludes a coil 284 embedded within its wall 286. Coil 284 ~~iay have a variety- ol'confi4~~.irations, for example helical, or be formed by a:
plurality of parallel ci:rcles connected by transversal moinb~.'rs so that when one or more. of th~.~
parallel t:i.rCl~.~s i4 Pt31l~.sÃ:l ~0 t~ti, tbe tra~~sverse ziiembers cause t[ie circles to become separated oile from tlle otber lonaitiidinally atid to form a cage-like structure. 'I`lte helical c~onfiigiiration instea, d may be cielÃverecl coiled of-i itself to provide tor ~i-iarrc~~~~er cliameter, g:i-vi~-ig aproii member 1.86 a narrow, elongated configuration, whicli may be released after introduction in the stomach to aive ~prozi menibe:r (8t? a wider, cxpaziel.ed conli;~,*uration.

[w 1-1 Removal of device 178 Irc~in tlie stzsÃ~~iaLh; or frotn another or~~;a~t which it inav be disposed, retlt3_ires that device .178 be collapset1 to assume a-iY elosYgated, ~iarro _er configuration aga.in. )`3ec:.a se .~~everta~-ig coil 284 to the configuration with a narrower diameter mav be a ratber coznplex operatioti if perfornied through tlie es%-.6agus wbeii coil 284 is provided with the beliLal configuration, device 178 includes a tez-ir ii~~e 288, so that; by pulling on one eiid of coil 284, for example, t~ti ring 290 attached to c?iie eritl of coil 284 coil 284 rips tbrotit*h tear liz~~ 288 asid becotaieS
extoii.ded, ena1?(im; a clinician to remove it in essentially ~= ~~~ir~ l'c~rzi~. 'I`he remainder of device 178 eazi tlien be removed together witb coil 284, for exani1a1~~ by having the remainder of'tievice 178 remain 1.0 attached to coil 284 after coil 284 has torÃt tear Ii~ie 288., oi, may be reÃ~ioved separately ti=~~i-ii coi.1 284.
[01] 21 Like in tl~~e p.~~oviotts embocli.n~entsm a variety of i.rtaterial~
~~~ay be 2~~ed t:o mar~~~amire device 178 ~id a variet:y of ancillary clevice may also be provided, which will itoà be described here agai.ti for the sake of brevity. [ti l3articulc~.t-, co.il 284 may be ~~~anufactured from a plastic material, such as ~ivlon or polypropylene, or f'roz~~ a metallic miaterÃals, sticli as stainless steel or a slizipe nlemory mater.i'at.
101131 FIGS. 14Aw 14t; c~.tiil 15A-15D depict ~iii.titl~ embodi~~~~~-it of the isxv,esYt:ion. Device 188 ii-ic:ltÃtit;, like in the p:rov'ioti,ly descri:beti t~nbotiiine ntsa a proximal ~~~ember 1 90 and a distal member 1921 ct~tinected bv a tether 194. In this ellibt?diz~~ent, however, apron member 1.96 is foldable along a crease or living hi_a;Fe 198 t(xat extends al~~ig at least a portion of tl~o circuz~~~~~~ence of the proximal, essentially cylindrical portion 200. Proximal portion 200 may ba~~~ a wall of constant ~ectit~ti., as sliown in F1G. 14A, or of areliecl crossr ~ectioii, as sl:~own, in I/'I(_; 15A_ [01141 Duritig delive:iA," to a target Ã~~rgan, for example, through the esophagtas to ?5 reach the stomaL_[l, proximal portaoti 20{) is e:a.tet7ded, as shown.in dashed linesin FIG. 15A
atid in FIG. 14B. A. coupling device, such as a string. is connected at one or more points to tlle fi-e~.~ idgxi of prom~~l"al Pc?rtion 20Ã3, for ~xarripl~-, at two points 2Ã32, and travels tow'arcl the iii:tier tip of distal tconical} portioti ~'Ãt~ of apron member 196, where it engages connecting metziber '206r ancl. then extends ititca ltir~iens (iispo:~eci withiiY tether 194 and 3 0 distal member 192-101 1--s] FIGS. 14A and 14C anti FIC;iS, 15A-1 5D illustrate different sliapes and naechanisms by wl:~ich cotit~ectiii=.:; mena~er 206 mav beLC~rne locked with i:~iatÃm, cCxvitv 20& `~,1ore laartictilarll=, FlC.i. 14C illustrates connecting z~~ember 210 cotiple~.-1 with relew~e men-ibc:r ? 12 by a cx~~~iiecior, sucla as a string 214. Con.neeiilag, member 2 10 is s1i<ipecl to bc:

gai;ed in. a triating ca-,,iÃy 216, ~Tv-hich is situated within stippzsrÃ
member 218 that i~
positioneti at the internal tip of the clistal {conical} i.~ortion of apron niernber 1¾36. As a consequence ot: Ãl7e engag~~~~~enÃ: of cc~~inectin4.~ member '2l {) wiÃ:l7 mating cavity 216, aprc~li ~~ie-iiiber 196 becomes lc?cked. in place in its c~ont~guration, witb i`olded, a4jac~~rit walls in its :? proximal {cy1i.tiiiric~.a1} portion 200. Conversely, Ão extract device 1.88 fiom the target organ (fbr e:~ample, to extract device l ~~ trozn t[ie stomach through the esophagus), the coziiiec:tE}r between connecting i$iember 2 1.Ã3 and release member 2 12 is severed, z~~ver-tin~,~
device 188 to its elongated, narrower configuration (sbwvii in FIG. 14B) and faeiliÃating extraction.
1.0 I01161 l~lGS. 15Ã`-1513 illustrate variants of connecting z3ieÃiibez- 210.
More particu1aTl4=, FIG. .1SB illustrates a variant, i.n. which connecting rnearit?er 1-20 inclufies three annular portions disposed on a rod that become engaged wi.th. a correspondingly shaped matfiig cavity. FIG. 15C illiistrates cuiuiecting niember 2212 as having two instead of t:liree ~iinu1z-ir portions, biià a l3ersoii ski11er1 in the art will appreciate that connecting members I;> caii be provided having substatitiall~~ an1= nutril~er of'annular portioiis. FIG. 15D illustrates ccazineci-i.ng member 224 as 1iavi.ng a sca11o}~ed profile, in which a ixiÃ-tiber ca.f'riciges 2-26 are disposed oti a rod mer:ziber. Mati~-ig cavitv 228 coiitainy grooves 230 that have slaal~es, nxatc:hii-ig those of ridges 226. Ian i.~4irtieLil4ir, in one vari4si-it of this embodis-nent, rid~,rc, 226 are incli~ie.d; so to facilitate itisertioti into mating cavit~, 218 iiiit also to hinder removal.
20 Instuad, the walls of proximal portion :1.00 ~~~~~me. released- and can extend as in F1Ci. 1413 bv severing the coz~~~ection bet~~~~~ti ct~tinect:ing z~~ember 224 and release meniber 232: for example, by severiii(.y strititw 234 in a manner similar to that of the previous embodiziients.
1.01171 C)zie of the advant:a~.~es of the preseiit embodirnenà iS that tl:~ere is zlt) first occludin<x Ãiiember: providing for device 188 to liaktc.. a lower mass t1iall some of the 2 5 previousli d~scri~ed embodiments, ~iid therefore to be lighter atirl Iess rigid, iz=r.iiatang the stomacli less, and in partictilar, irritating the pyloric. valve loss. Like the preceding ~s-tibodiiiieTits, device 188 mar, be manufactured ti~~~~~i a variety of anaterial.s and rnay also be equipped witll a: nuniber of ~ccesso:rv ~~~~~~~ponents for feedback and d.ata tra:~~~taiss:ion and for subst.ant:e ~.sltitic4n. St3t:h tziater-ivtls aii(l accessories will iic4t b~.~ described again here 3 0 for t:lie, sake of brevity.
101181 FIGS. 16A-1 6B atid 17 depict a tenth embodiment of the iiiti=~litioli, in which a ci~-vice 236 ir-iclud~s a proxinacil mei:riber 238 and a distal i:rieÃ-rii~er 240 connected by a tether 242. Like. provioiisly described enibodiz~~ents, proxiziial member 2138 includes >ui apron. Tne.~~iber 244 and a i7irst. occ:ludin;~,* mc:rnber ?46, which, Ra the larc:sel-it enibodiniez3t, has a shape re.am.1iscent of the letter "Y," ir-I particular, has a sieni portion 2418, extending f`rom tl-ic inner conical til.~ of apron member 244 (which correspor-it1s to the proxi~-nal ei-id of tether 242) to sLipporà a. c rti~ed e[enaenà 250, typically a ser:z-i.i-c.ircular or semi=elliptical elez~~ent. More partictilarly. FIG. t txA sliows that ciirved e1~~~~ent 250 has a rei.tit:orced, doublerclayereil 5Ã:rtictlire formed by having c~.ti oLiÃer layer 252 assl~rne the curvature of a base layer 154., as sliown in FIG. 17. This "cup within a c-tipõ stnlctur~
provides for an e<~sy iti;ert:ioti iritE} azi or ;xiiri such as aii easy insertion itito t.lie. stornach from tlic esopbagi~s while device 236 is in tlio configuration of FIG. 17, btit also provides for a firm, rsiore rigid. ;ti-Licttire in the coiiti~iii-ation of FtC, 16A, dtie to the layured- structL3re. of 1.0 eun~ed eleiiieilt 250. `l'be e:bax~geovez- froz3i the sÃz-tictLire of FIG.
17 to that of FIG. 16 is enabled by provicli~ig a string 256, coupled to otites- layer 25-1, to #:rave1. through hia~~iens into stem 248, tet:her ~~?42 and distal member 240. As show.ii in HCi. 17, stri.twa 256 mav t~~
coupled with outer laver 2-52 in two points, but oiie, skilled in the art will appreciate that yt-zi~-ig 252 ~~~iav be coupled in oiie or r:ziore laoi.tiÃs. FIt~3S. lfiB and 17 tlirther show that a I;> recess Is cane~.-l in otiter layer 252 to house a release o1emetit:
,w}~ich, like in t:lie, previous embodiments, is ti;~ed to unlock first occluding rnember 246 prior to ~etnovial .f'rorn the stornaeh or ot~~er omam Alternatively, strin4~; ?~6 may be cot7tiectecl to one or more loops or rhYos 270 4it the periphery of otiter layer 252 and travtl through a conduit withisx outer layer 252, exiting that cotidtiit: in the area sliown in FIGS. l 6A- 1613.
20 101191 Otiter lay-er 2521 is locked against base layer '254 by pulling on string 2156 (for exaznple, bl= pulling on snare ball 258), aiid bv having protrusions 260 extending frotii strin,.~ 256 engage a Iockitig ring 262 disposed in the lumen either of stem 248 (as i11tisÃrated in FfG& 16A ai-icl ( ÃiB) or ot'tet1~er 242 (as i(lustrated.in FIG. 1.8, i.n relaÃ.inn to a similar eÃiil~~odiÃiiciit}. Protriisiotis 260 arc. showÃi as spherical protrusiotis in the illustrated ?~ embodiment, but oiie skilled in the z-irà will recognize that other shapes are also possib~le.
101201 FIG. lS d.epicts an elevetit:li eziibodiziient of the iti~ention, in which device 264 is constructed sirr$ilar-1y tc.) device 236, except that first occluding mern1~er 266 is ~io#:
coniposed of two separate azid distiiict layers attiched to a stem, blit itisteaci includes, ttvo layers attached to a stem that are t'orm~.~ki by having a clc4s~.~kl mers~ber '268 fold on itself in ~0 tl~o manner of'a def'lati~ig ball. ~~~~o of the advantages of device 264 over device 236 resides in the sznoot:l~ ed;.yes of first occluding member 266, as opposed to the sharper edges ot:-cLirved cIem~iit 250 i.n. device 236. LtiÃvim~x hiti~xes Or creases that facilitate the .f"o:lci:ing process may be optit-~tially prov~~ed. :Lookin~ and. uiilocki~ig mechanisms are t:lie. sa~~ie. as for device ---?36 and for both devices 236 and 264. A variety of m"iterials a.tid accessory cotiipor3ents mav be esYvisionet1, iri the sarsic manner tis for tl-ic pr-ecedisY~,~ eri:ibotliments-(Ol 211 1:rnbodi~~~~enÃs 236 and/'Or 2t~4 may be selectively reinforced in certain areas.
For example, if embo~.-limetit:s 236 and/or 264 ~~~~re, made of a silicc?r~e material, a fabric.
insert tz-iav be inserted in the area surrounding release elei-iiet7t 269, to decrease the risk of tear in that area.

101221 FIr. 19 depicts a twelf:t:li i`ank?otliment of the i~ivetitiori. Device 271? includos a proximal member 274 and a disÃal member 276, connected olle to, tlic other bv a tether 278, In tLam, proximal member 274 i.nc.lutlus aii apron Ã~~~~nibur 280, shaped like in the 1.0 previously described embodiments, and a first occ;ftidix~g i-neniber 282 that lias a bulbous shape, ~~iatie of a ~-o11et1: hayer in the l-ashit3n of a ~~iail. shell as described M US. patent app[icatiun serial rio. 11f7{3'?,888. For introtlucÃiun into an organ (for example, intTodUCtiOtI
irlta the stomach through Ãlhe esophagr.rsl. first occludÃn~~ meniber 282 is distended (not rolled rmil3); providing device 272 with a iiarrower, elongated shape. lii the disÃ~iided, elongated. state, first occlti~.-lirig z~~ember 282 exhibits a wider, more btilboiis base and a ~iarrÃzwer; tongue-like exiensaon. As shÃzovit iii FtGS. 24A-20C, a string extends ftÃzm tlle iil~
or an interinediate poi.tià ol'Ãhe ionguerli:ke exieiision atirl rnaz travels Ãb.roligh z-iti opening M
asxÃ1 ~icros; the base so that w1i:er3 tlxt string is ptÃllet1, the MgUe-like exteni.siEgn rolls on itself and catises first occluding meniber 282 to asstime its contracted, wider configuration showii in ivlC, 19. A bLit.toii-like retaini.m-> member on the te~~~gLrc-lik~e extension eventually travels Ãbrough an~.~ enages t:l':=e, opening in t[ie base, locking first occluding member 282 in the contracted configuration. That button- like, retaining men':=1~~~~ may be severed. from first c~CC( dÃziw member 282, enabli.r:rc~ first c~cel~idiziw member 282 to revert tc) its elor-igated, narrt~~ve:r shape.
2 5 10-1231 r'4[ÃernaÃive1y, as shc~~~~ii in :[tIC-;S. 21.A-21B, the string naav originate from the base of first occ-lti~.-lirig meziiber 282 arid travel to exit first occluding member 282 at tlie tip of the tc?tigtro,.lil:e exteti;io7:-g, so that a pulli.7:-gs: of the string catises first occluding iiiember 282 to roll oii itself and acqui:re the contracted contiguration, eventtially securing the string to a rel~.~a4~.~ men-iber. In rhi.s altertrate design, first rgce.ltakling metziber 281. may, 33 0 revert to tbe elongated, narrower configuration eit:lier by severirig the release member, or bv ptilling on the release member and by causing t.lie, string to c-tit t:lirc?tt;.~h a tear 1ine, ~~~i-iir:~g Lip first occliicliii=.:.,f mena~~r 282, as ;hc~~~~ii .Ãn 1-1G&
22Aw22(`.

[0124I i~ÃfllmimF Exarnp1e relates to the procecifize i-:zsr ir11plaz3tit.1g) and C, explantin~.r a trans-pyloric device, sUCh as device 30 cir;sc;ribeti abovea irr the stomach. of a r`Icrg.

TABLE [

S['EP DEVICE [ MPI_.ANT1'RC_}t"El;)t.s RE
`r, t AÃ-testlieÃize fiasted dov aiid place arl table.

~ EnstÃre. that the long endoscope will be r~~~~~ (Olyr~iptr; model CF Type 100 TI, or equivalent).

~ Insert vi.deEg tape into endoscopy equipment.

4 Place endosetspe through the estspl~agrzs; and iiit:o the stonia~h.
5 Drain stomach contents and iri#late the stomach.

6 Make sr.ire, endoscope video is r:er:.ording throughout the eritir~e.
pror:.~dlrre.

7 ~erfcrrm t1:rorough baseline er:rcic~scopÃc analysis of the sioniach, looking for ar-~z preexisting erosioris or trlr:.en, tions pa.1=ing partictrlar attention to the lower >6.sophagwal sph.ir.rcter, the ar.rts-al remora, <~~id the proÃirr--tai pylor-trs. Dcrciirz-iciit findings on tlevice insertion worksheet.

8 Place the scope through the py?l.onic cylirrf,ler;= to nile out mconzpeteut and/or patulous pylorus. Inspect the liiiiirg of the duodeirtain aird duodenal bulb for evideriLe of erosican iand;~Vr ulceration. Documef.ri t:i.riclin`.:.,fs of.r device insertion worksheet.

9 Pr:ill endosccape back out of pyktonrs to the Cl:-> jtri-ictÃoii (scope jtis# entering the stomach).

~ecorcl the er:rdoscope ciept:(-z at the CFEjUDC0.01-1 crti the device rrrwe.r-tior.r worksheet.
11 Mark depth of GE. jr.rnctit?n trri the delivery device wit:li respect tt?
the proximal end of the pE3ci (trs:i~-ig colored tape).

12 Record devic-e ID ori the devic-e insertion worksheet.

S'I'1:n.P ~.~E.l'[C1n.IM!'LANI PROCEDURE

X ') Lubricate tlte delivery device alottg,- its length witb surgical jeliy:

1=1 Insert delivery device Lif-iti:I G1; junLt:ion naar1s..is reaclied. This will ensure that the pod. is f.itlly- witbin the stomach. If necessary, insert delt~ ~ry cat:heter until res.istaiice ls iL:it and remove 4t.iff pod closLarL: rod from b{ilf of t1le delivery pod length, Theii atl.vanc~e deliver-~~, devie.e. atntil proximstl portion of tlle pod is past the GEzl l3nct1Cgn.

15 Itisert endoscope 6c..side delivery devicc.. a obtain image of pod in the stomach.
16 IZemove the stiff pod c1osu.re rod to1` [ly re:[ease the device from the pod.

17 Pull t.lie. pull-ring i~tit:il locking indicator is visua1ized.; this will look the imp1ant-18 Ctit the red fiber anc113LI11 the ring to ~~enim-e pttll eozd:.

I9 E;~ami~ie the stomach lining to cri.sure that no gross tissue damage has been catts~.~d by t[ie placement ati~.-l removal of the ~.-1evi~e, ati~.-l delivery system.
Inspeet the stot~~ach body, antrumz and pyI~rtis for evidence of erosion, lacerat:iott: or other forms of diatna4~e and ~~e~.c~~~~. c~t~se~~~~.ic~z~s c~ii the device placement ~~%c~~~k;~l~zeeÃ:.

20 If ~.-listal bulb ~omains in tl~~ proximal portion of the delivery pod, utilize the endoscope to manipulate the eliqa1 b (b clear of the de:Iiver-y pod.

20 Slowly rer.nc)ve the endo4cope., 21 ReÃiiove deIivezy system, 221 Awaken and recover aiiiiiiiil.

12-5 ] The aniÃ~ial will be theÃ1 be recover4d aiid lioused. Once the veterinarian detexm.itles that t(ie at7.imal's t~ecovei-z is ~otral3leÃ:e, the aninia:( wi:(X be tra~~~ed to a:(lous.it7, facility in an individtial itin. Water will ~~~ available cid fibitr,an.
Animal 1;eed, per 5 sLlaecclLiled t~edim~x, mav i~iclLide }~rophylaLt.ic antibiot.ics to protect aga.inst respiratory in:1`eciion.

SI'EI' DE.1'K_'l~. EXPLANT F'`F' OCEDURE

l Anesthetize f'asted. dog and place oji tatsIe:

2 ~~~i-isiire that the long eiidoscol~e will be used (C3lyinp~~~s model CI=
`T'ype I flO"I`I=-, or > Itisert videci tape into F'luoroscopy [~',quÃpment.

4 Insert video tape ir:ftca oncl.osec4lay Eqt.ti~.~sr#iont, ~ Place endoscope through the ~~opbaiwus axicl into stoÃiiacti.
6 Make sure endoscope video is recording.

7 Record posit.ion of deviee (t:rat7spy1oric, fiilly int.ragaatr.ic or not visible iiom ~..~a,ti-ic space, on tb~.~ device r~~~iova1 worksheet.

~ Perform thoro g[i endoscopic arta:[ysis of gastric space Ioo:king 1=or ero5.ior7s or ulcer-at.ions paying particular attention to the. lower esopha;xeal sphizicter, the proximal pyloruS and Ãl~eattÃr a:l region of the stomach.

9 If device was not visible from ~,~~.stri~c space ia~ 7, enter dt~~.~ele~~~.~~-.~ ~:sxd se~irclY for huplant, if found.. return to line 10: if not found, perform tltior~scc?py, to locate, implant antl go to line 22.

Cr.it the string at the top of tlte TPS to release t~ie, :lock:ing wu 1,,wztsm. Insert loop snat-e (240mm) into worki~~g c(xaii,txul of s;ndt}scop~.~ and srl~.-~re device retrieval ball.

11. Usi.7:-gg the stifire, position the retr-iev<i1 ball 3-4 c~~~ ~~~~~iv frc?tn the distal end of the endoscope.

12 Nl.Wntain:{-irtn grip ar-t?und retrieval ball witb tl:tes.7:-gare.

13) Remove ~ti~.~loseo}~e wliile maintaining the positioii of the siiare wit[l respect to the i.dE}Seope, sL3ch that the implant tollows the ~~idoSeope out through the eso}~hagus. As the implant is retr-ieved, the esop1ia4~ea:l orifice will cause the unlocketi. spiral to L3nfur1. The shell will collapse at tbe. lower esopliageaI
sphincter and. the entire device will be r~~~oved along wit.li t[ie endoscope.

SI'E1' DE.1'K_'1~. EXPLANT F'`R W1~;DURE

14 If device remains in animal, repeat steps 1 0-1 ~+.

15 Rinse the implani with water to remove any renaaÃziÃng sÃ<zmti.ch contents.
Label the device with t:l~e, animal ID number anci date and time of removal, and place, in Ziplock 1?aw for analysis. Note ~~~iY isstiL:4 wiÃli device removal or aiay observations made during the removal procedure cgil the Device removal worksheet.

16 Place the eÃidoSc~pe back through tlie esophagus into the stomach.
17 Advat7ce et7doseope across pzlorLis i.tiÃo the duodenum.

18 Perform Ãborough eiidt?scopic analysis of proximal 10 cm of dtiod~lium lookilitw ttir erosions or lileeratic~iis laaying part.icularattenÃion tc) the d.iatai pylori~s and the duodenal bulb.

19 Rernove encioseope and cont::inue.
20 Wak~ aninial and retiirn to cage.

[01261 A~~ endcsscopic eva1uat:ion procedure c?# the irril3lanted devii.e is described tioxt.
101271 After standard. fast, witb water provided ml libituttr, tlie, dog, will be brought into a ~.~atrposu-built operatin;F room, wbich will include an operating table ~~i-icl arlesrlletic:
tnacltine witlt ~O-!, re5piz-atory, a pulse rate mailitor, aiid a~~entilator.
AneSÃbeSia will be titrated #t3 rnaintain the do~.~ at the appropriate l~.~vel of anesthesia for at~ endoscopic procedure as deÃermir~~ed by the veteri.narian..All allin'la:[s stU<lied will be i-iic~ilitc~~~ed l`clr end-tidal volume COy, respiratory rate, ~~id pulse rate throughout tl~e, aiiestl-ietie procedure.
After a~-idtictic~ii, the doga wall be intul~ated endotracheally aild endoscopy will be per~ormed-[0i; 281 C ~irsory entlcscopic evaluation wili be pertormeci ~~ii anit-nals in Control.
Grotip 4 M order to ~i-iaiire similar treatment as ati.imals in Grc~~ips l, ?:
3 and 5. 'f horougla esxdoscopic: ee>altiati.Eg~-i will. bt complettd on all tinis-nals in C-3-rEgatps 1, 2a 3 tinci .5 Lintil they I;> are terrninate~:-l from the studvaccording to the following protocol:

I ABi_:l: ! ( f.

S {f :l' E NDOSCOPIC FVAL t.=ATION PROCEDURE
I Anesthetize fasted. dog and place oti, table.

I f<is rv that the Imrg encloscope will be used (Olyrnpu3 m(?ciel CF T~,pe 100 TL
or ec1L3ivaIerYt.).

3 Iiit;erà vi.tleo Ã~peiutc, endoscopy ecluiprnent..

4 Place er-itloscaf.=ae througli the esophagus, and iiito the StÃ~~mac.h, Drain sior:z-iac17 contents arid i.ritlate the siorii.-Ac17.

6 Make satre endoscope videc) is recording throughout the enti:rr;
proc:etltire.

7 l'erforni thorough endoscap:ic anilysiS of tlle stomach, looking for a:r~v erosions, ulceratioiis, filZrosis, sterio4is, se.arring, webbing or atresia, paying particular attention to the lower esophageal spl`#incter, the antral region, the gastric.
atid ~.-lr.rode,nal pyloric re,.yit~tis and tlio dtro~.-lerial btrlb. [:~~~~imei`#t findin(ys on endosLopic evaluation worksl:iecÃ:.

8 in t[i~ everit of irlcerat:~~t.i: assign the u1ceration a grade andbiopsv, if ~~equire~:~_ DociirtieziÃ: ti.ncli.nt.~s csi-i rriid~~seopa~ evaluation worksheet.

9 If a d-evic:e is present, tioctiment its orientation and position on t(xu uiitlcgseopic:
evaluation worksheet.

If a device is pi-e-scirt, perform tboroatglr analysis of tlic device including assessment of : 1) the intogr'ity of the shell, tet:her; ceritral spiral and, if visible, distal btilb, 2) t:lie. state, of t:lie, snare ball iricltiding absence or presence of tension in :[ockar'-ig cord arid ar~z larotniyioti of the snare 13al:[ otit of the central ~.-lelaression. Document findings on endosc-opi~ evaluation wc?rkshoet.

11 t:t a r`Iev ice is 13reser'-it, record the lareser'-ie~e atir`I location of aiiv foreign materials within the device (such as trapped fibers) and any notable discoloration.
Dociir-iiezit #i.nrli.n~.~s on ci}~.r~s~:c~l~i~. evaluation e~rt~r-(~.sl~eet..

12 Slowly remove t:lie, endosc-ope.

S'I'ln.P ENDOSCOPIC.. EVALUATION PROCEDURE

13 Awakenand recover animal.

~01291 -l'lje animals wil:l tlier~ be, recovered and liotised, Once the x=eterinarian.
de:i2rn}i3te's i'l:a'at the anitnal's recovery is complete, animals will be mor4(i to a housing facility in an individual riiti. Water will be available ad libitarm. Animal fee-d., per 4; schedtiled f~eding, may iticliide proplil=lactic. antibiotics to protect agai11sà r~spiraton~
infecÃion or p.t-otctn pttiitp ir:tltibiÃo.t-s to treat diagnosed itlcetution_ [01301 FIGS. 231A_2: s+.~', '4A-~~.4C, 25A-25C, 26A-26C, -')7Aa'-'):7C, at-iCl illustrate metlaoda of implarttrn4~ a device in the stomach or other cw gan based on inflati.n=.~
t17e device or othez~vise haviiw the device increase in size in the stomach from a smaller 1.Ã3 vol-ort-le during it~sert.ion. These figures should be understood to have a getieric illustrative latirpose ctiilv, and that the specific shapes of the devices as disposed in the gaatroit7testinal tract are tc? be. selected amona those describeti in the Pt-OV.iOtaS
embodiments.
(01m] More particularly, FIGS. 23}~ 233C illt.tstraÃe a device introdiicet:~
in tlie stomacll or cttber part of tlle gastro-intestinal tract in ati elongated conftg~ttratictn (Fi.G.
15 '23A), which is expaticclerl to att intermediate (FIG. 23I3) at-id evetit;Ltaliz a final cctntiguraÃi017 (1=~1G. 23C) by injecting a foam witli an approiariate catheter, causing a volut~~~ expansion.
101321 F [(FS, 24A-24(' illtt.,-,trate a process similar to that o#'Fit_i4.
23A 2:3(_'. ex,.ceDt that zi SLibstanc_e sttc_h as water, a rea~>~.~t~.t at~~~,c~r a catalyst, is iti jected through the catheter, which l.ipotl contact w1tli a pI`Cgdl1C't already present in the device causes a vC31llme expansion 20 of that prodLict-[01331 FIGS. 25A-25C illtistrftte schematically a tnc?fie of plac~.~tnertt of tb~.~ c1evice4 of FIGS. 23Arc23t; atid 24Arc24t` tb:roxtom a catheter introduced tlirotigh the esophagus (FIG. 25A), tlxcri. ti4ed for it3fitsii-ig foa:tn or a grcaWth st3bstattce (FIC`s. 15B), cattsing the device to become fully rtiset-terl (FIG. 25C). C'ot-iverselNf, FIGS. '26A--26D
illustrate the 15 removal of that device by showing the device in its placed state (FIG.
26A}, the attachment of a device extractor (FIG. 2613), the acti va.iion ofpredeÃ:ertni.nedfailure pctittÃ:s (FIG. 26C'), atid the extraction of the device (FIG. 26D).

101341 F1CS. 27.A-27C illwstiati other otzibotliments, in which rsittlt.iple distiil bulbs (1=~1G. 27A} or a larg.er distal btilb (FIG. 27.13) may be present to slow transit of food. in the gast-roag-ItestinaI tra4t. or in ~vhich t7o d:ist.al bulb m~iv be present atirl tl~~ ~e-,,ice can act as a space filler (FlCi. 2 7C'}.
(01351 In l3articular, FlG 27C illu5trates, device 293., which .Ãa z~o-nl=iMtired as an occltidin~ ~~~ember tbat resides in a stoz~~~~~ 29-5. :Ã~evice, 293 has no tother and no second ocLl riim~x member atiri in that respect, device 293 sla~~~~~ a varial7t possible for all embodiments of t:lie, iti~~~tition, namely: that while t:l~~ embodiments described hereinbefore, iiritl hereinafter have beert i11ust:rated as iii.s;ltad:irt ;x a proxin$<i1 r~~~t-riber, a tlistill I-neanber and a tother, the disÃal zneniber and./nr tlie teÃber may be not be ific-ltaded in variants of those embodiments. For example, a variant of er.1ibod_iment 30 may inclticl.~ only ~.-~rotiinial I.{.~ ~~~eniber 32, or proximal ~iieiiiber 322 aÃid distal ~iieiiiber 34 c;oÃiiiec;te~ one to the other witboztt tether 36, or witli a tether 36 of dif'#:er~iit lengths ~~id ct3nfigrrratit?ns. For examp1~~, tetlie.r 36 may connect mtrltiple tlist.al members as in the striICtUre of device 291 in HCi.
27A.
[01361 Additionally, device 293 ~~~iav include one or inore el~~~ieAtt_s structured tx?
alert the patient or a clinician or other att~ri~.-ling personnel of a failr~re, of the device, w'hetlier such fiffltire is real or potetit:ial. For example, a si~Y.~ia:l may be transmitted that alerts the patient or other attending persor~~i-iel of f[ic breach of wall 297 of device 293, making device 293~ at risk of migr~ting from stomach 295 and of passing into t1110ilCn0m 299, both losi~ig its functionality in the st~~~~ach and tiegatively affecting t[ie functionality of the intestinal tract, typically crYdirY;F tip etipelleti. from t(xu patient's botly, as feces. Such a si;.~nal may be provided b~;= tlio activation of an e~.~:.er~tri~. liiotc~r or of a ~~ect~a:al: electric.
or electronic al~~~in system associated wit.li the integrity oi`wall 297. For example, chan,.~es in pressure, mec(aaiiical s1~-ipe, conductivity, capaeiÃ-ance, resistance, pll, or optical properties of a fltiid caiitai~ied in device 293, or tlie activation of e:le.c-tric or e:leeÃr~.~ii1c ~5 monitoring systems associated thereto, naay trigger slicla a ;si~-nal.
101371 In one variant of f[ie present enibodi~~~ont, device 293 includes a patch 301 tlesis:ried to pl~~gan inflation c~~~~sung in the outer ,l:tell oi- dval.l 297 of device 29:3. Mt3r~.~
particularly, patch 301 defines a discrete region of increased hardness ancir`or thickness, Chrouo(x w(xic_h tiev it:~~ ?~3~ rfr~.y b~~ inflated or fil(c~~l. In t~~is vvtri~.~Yt., an alert syst.~'r.zi ~t~~
~~ may iiiteract: with sholl 297 of devi~e, 293 in any region of shell 297 or only with patch :301. 11.lort systems of tbis kind. are disclosed in PCT patent application WO
-1t.tf3fi;`t ~~~57, which are inLorpoutted herei.ii by reier~iiLe.

101381 In its simplest variatiÃ, devic-e 293 is lillecl: with a ncan=c.on.tluctiv~ aqueous niediatrri (for exanrp1e, witla po1yetlaylene glycol or witl:i >niother iit~~~-conciuctive, osmotic hydrophilic material dissolved in de-ionizec~ ~%vater}, and alerting system 303 simply nlonitors tlle cor-itlt.it,tivity or other electrical properties of tlxc flta:id, whicl-i \vill change rl.ramatically whei7 a breach occura in shell 297 of device 293.
Alternatively, device 293 may incorporate two electrod.o-s on taateli 303, otio of whicb face-s externally atid tlie, other otie internally, such that a voltage applied to c~iie electrode is only setised by the other electrode if there Is a breach in sbell 297, wbtch is btiilt of ahighly insulating material such iis silieozie. In this variiirit, device 293 ~~iay include a battery wit.h longevity greater than implant duratioii, as well as ati alertiii4.~ system. :30; (such as an ecc-er,~:Ãrie znotor, a radio-frequency a(er-t system, or an acoustic ~~nerator) to a1er-t the patient or attending persoii_tYUl I.{.t that a breach baS occui-red.
[01391 FIGS. 2SA-1-S+C, further illustrate the ~~ioc~o of'rise of a ;=astric :{illing (~ovice designed t-k} increase in vo[tume iii the stomach. I~~ ~~ar&U[arjICi. 28A
shows insertion of tizo deviee. FIG. 28B shows i~~flat:ioii of the bulbs, and FIG. 28C shows tize intestinal mi~xTaÃawl of the distal btilb. FIG. 28I3 iiistead shows t[iaÃ: obesity treat-~~~~ents may be I;> enhanced by adding gastric fillers in tbe stomacl'i_ 101401 FIGS. 29:^arc29C .illustrate a thirteenth embodiment of the .ini~ention; in whicli device 292 ii-icli~~~s a taroximal mei-ii1~er 294 that is coii.tiected tc) a distal mern~er by a tether (botb sxEgt shown) in the sa:ine rzi4ii-iner as in the previously ciesc:ribeÃ~ embodiments.
In tum; proximal ziiember 294 is composed. of an aproii ziiember 296 tliat surrounds a first 20 occludim-x meÃ~~ber 298, tl''=.isposeti. hY an essentially ceiit.ral position within apron member 296.
101411 First occluding ~~~e-mber 298 is ctrueture~.~ to be tormed from an elongated, s:i~-igle (aver ConfiguraÃ.inn used clUfÃrl- tlteirlse.rÃ.ion processinto the stomach or other nz~wIn of a patient ÃÃ~~ a tc:leSc:Ã~~piiig, multi-layered configuration after tm~.=aiantatioll in the stomach ?5 or other organ is aclai~~~ed. More partic [ar1y, first occluding ~~~~ember 298 includes a dista1 part 300, a ~ontral part 33021, and a proximal part 304, whic}.i: in variants of this ~s-tibodii-tieti t; ma4' be divi(ted c3n~.~ ftwi.i the other by liv isi;=
hinges 306, oi- by cr ~.~as ~.`~, or Vy slots, or bv localized thinning-, of the wall of first c~ccludhw member ~'98., or may iList be folkit~~i one otYt.o the other when pressur~.s is applied on prc4:~i.ma( part 304.
~~ 101421 Proxtmal part :.~04, i~icltides a proximal protrusion 308, exte-itding in a direction opposite tc? the Ãetber, a distal protrtision 31 U, extending in tbe direction of tbe tect~er af-ici sbaped to ir-iterferetice fit within mating cavity 112, a~id a body 3 ).1 4, supporting p~~oxiziial protrtisi~~i '308 and distal protrusion 310 at opposite ends. The interference fit betwceil distal prt~Ãrusi.on 310 and rnati~~g, eavit-v :312 causes first occ1tidi.ii- member ?98 to gnaintain its contracted shape after the telescopic l=Wdmg of proximal part 304, ceaii:rtll part 30~~ tiriii distal pcirt ~00 osYC onto l1YC other. TIYi, may be tichicved by t,orsii.~ressii3gptoxirnai p.rot.rusaoti 308 distally, for example watla a catheÃer.inserted into the staniach and pushing in the direction of t[ie tether, or by having a connector Ãs~~~h as a string) ain through mating cavity :~ 12 ~iid ÃhroLigh a lr~~~~~~ii in the tether and in the distal mei-iibe.r, to et7ab1e a clinician to pull distal proÃi-usi~n '31 U into mating cavity 3l2. In a vari==:alit: of f[le preseiit embotl_irt~~ent:, <is well <is in vari,an.ts of the previcltis1y deScr.ibeti embodimerits, the ;trin~,~
may exist devic~e 2922 not tliroiigh the distal member, but -rom an openitig situated in tile tether in device 292, 1.0 I01431 Wheil it is desired to reiiiove device 2.922 fiioni the stomach or oÃlter organ, first occluding rner~~ber 298 can be uiifol(ted to regain its elongated, r~ar-rt?z.i~er coni-iguratiOR
in different wavs. In or~~e variant of the -preseiit embodimenÃ, first occl~idiilt) member 298 ~~~i be iiilfulded. bv simply pulliiit# oii proximal prot:ruSi~~~i 30S, Ãher~~~~ overcoming the interference fit between disia[ protrusion 310 andmaÃi.ng cavity :T12.
_!nanoÃ:17er ~~ariant of I;> the present embo~.-limetit; proximal protrusion 308 and distal protrusion -3 10 ar~ co~iple~.-l t~lle to the other by a connector, such as a string, so that wher-i that Lt~iiy-iectcar is severecl (for ~~amlale, bv cutting t17e atr.a.1g), proximal protrusion TÃ~~ ~i-id distal protrus.Ãc~~i 3 10 become atncotipled, witb d:isttil protrLtsion 3 10 remaining cosxtainec1 within mating cavity 31.2 while p~~oxiziial protrusion 308 extends out~~--ardly.
20 101441 FIG. 29B illustrates the sa.~ne embodiment of the inveiition as shown in FIG.
29A, ex~~-pt: that disÃal protrusion 316 and mating cavity 318 do not have cyliti~.-lrical shapes: orz more general, the shapes of a parallelepiped, as in Ficj~ 29A, btit iiistead have more expa~-ideci sI:~apeR, for ~x-imple, 1iave the shape of a sphere supported by a cylinder illustrated in FIG. 2913w thcxebv proktidiÃig for a tigl-iÃer iÃlte~feretice fit Ãhet:ll in the ~~ embodiment s[io~~~~~ in FtCJ. 29A. Ot7e skilled in the art wi[l appreciate that distal protrusion 3 16 and mating cavity 3 18 may be shaped in a variety of other shapes as well, all which fa.ll witbiti tlic shape and scope of tl:-~e present ~01451 FIG. 29C
ffirthe:r illustrates the siniilar enibodi~~~enà of the i~ivetitioli as showti in FIC'i. 29R, except that no proximal or distal protrusions zzi-Ã.~
prÃ.~selit. More 30 particularly, FIG. 29C illustrates the translbrznatic?n of proximal meniber 320 i`rom tile elongated, narrower configura tion sliown on the left hand side to the wider, contracted configuration ;howr:~ ~~i-i tl:~e ri~Ylià batid side, and also s1iows l:~ow suct-i trartst:ozxniatiÃzn. Ã-~lav be attained. by ptilli~ig oii a stri~ig 3212, wbi~~ may be c~~~~~ected in one or ziiore poiiits to the Pro:Y.iMal end 3214 of proximal .~~ierribc:r 320. 1.11 its low ~larofile delivery z.c~rttiwuratimi, oeL1urIin4 mc~inber '34? may be titta.c,lieci wa c.irc-ular w-a11 sectizsras ~vlai4l~ may evert oz :l`o1d ttpon thernselt<es to fi~rni the deployment configuration shown. In this ptirti:t;tÃltir example, first ~~al sectioii .{ ~avir~~~ ~ii average taickiiess o1, e.g., 2 mm) rn~~~
exÃ:~i-i at a~~ angle to first interlockable wall section 334 (hati=iz~~~ a~~ avera(.ye t:liickness ra~ig~~ig from, e.I to 3 nim). A second i.titerlockable wall seLtiot7 338 (also 1~aving a~~ average thickness ratig:ing -rom; e.g,, I to 3 m.m) may extend from first interlockable wall section 3334 witli a coaZ~iplementary wal.l Sectioii. 332 (having an average thickness of, e..g., 2 mt-ri) witli occluding member 342 attaclied thereto.
101461 When ruconfigitrud for deployment, c4c:c.ltitliiig member 342 may be tirgecl 1.0 via string 3222 towards its distal eild sucla that 5ecottd interlockable wall sectioÃ-ts 338 Ãixay rotate,anti evert abt3u# hinged regiosi :326, e.g., living hisi;=e, such that first wall sur:{-iace 3:36 and second wa11. surface 340 cotize into apposition relative t-k} one aitotlter and complementary wall sectioii 332 pivots abotit hinged region 328 to eoÃtie, ilito contact against 1inst: wall sectioii 330.
I;? 101471 The apposed f'irst and second interlockable wall surfaces 334, 338 may be confiai~~~ed along tticir interi:'ace 144 to teiriporarily or pez~~~~i-inently adl~~ere to ~~i-ie another, e.g., via aii acl.laesive, as illtistrated in the crossrsectic~iial etirl view of lAG. 30A.
Alternat:ive1.v, each of'the t-esptcti.ve surf4ices :tnaV t1ei`ift. SttrfilCC
teatt3t-CS, interlocking ridges 346, whicb intordigitates relative to otio attotlter to prevent or inhibit t.lie, u:nfoldintw 20 or tiiilocking of the device back into its low-profile configuration, as i(1u4tratetl in the cross-sectiotial end. view of F1G. 30B.
101481 A device constrricted according to tlie -principl~s of the present invention (as described throiiff(a a nur.nlier of representative embodiments) iS s .Ãted t-iot only For the trc:et.tinent of obesity, btat also for treating other ailÃiietitS. Exari-iple:s of sticli treatments ?5 it7cltide treaÃments to restore noz~t'nal ~l cose tolerance to a diabetic or prediabetic sut:~jeLt, or to delay or provettt t[ie progression of diabetes in a su.l~ject by inbibiting fasting itisulin sicretic?Ti or gluccls~.~-stia-nulat~.~fi iti,tilisi secr-eti~~ii. Other examples of ,~ich tr-eati-nents include the treatinent~ of patients suffering frotti otie or niore diseases characterizerl bv obesity., int:iti(ling h~?P~~rpl~vtgi.~., ~.1~+4lipi~.l~~a~i.~, Pr,.tler ~~`i:lli ;~~`ti{~_ro~~~~, Froelich's 3) 0 st%nd:rt?me; Cohen s~~ ~idrome> Stiziittiit syndrome, Aistrotti syndrotnez Bor_jes~~~ sylidrome, Bardet-Biedl syndrotnez or hyporlipoproteiz~emia, types 1, 11, III, and IV.
[01491 WIiile an example ca.f'ttse of the presetià Ãzivezition for the trecxtmeiit of diff.i~reaà ailments has 1~~~ti described with ref~retice to the first enibodiment (device 30), the other ei-tiboditziez3ts described herein are eil'itallv suitable for i:lie treatnienà of Ãitose t~'~~s o:l't1isetises.
(01501 r'4:[so as previously mentioned, a iltt.ni1~er of a.acillary con-zlsonents n-lay be iticltided in a device coiistrticted according to tlie principles of tlic present invention, for exz-it-iiple a~~~sora or tra~~smiÃÃers that pr~~-,.4de feedback ~i-itl other data to at7 :itiÃra-Lor,aoreal or extra-corporeal processor. The device of ttie present iti~~~titioz~ ~~~av also be striicttlre~:-1 to release a therapeutic sL3b;t:a-ii.s;i to treat predetert.nined conditions, or a n$ildly irritating substance that is released when an undesirable substance (for e.~aniple, sugar) is detected in t(xu stomach or in t(xu organ where the device is tiispcgsecl, Stic:h a Subst.ance may be.
1.0 contained in a reservoir axtcl be dispersed in the gastro-intestinal tn, et either over t:ime, or upon opening of the reservoir bo, a sensor. AI#eri.iativet4', such a substance ~~iay be coated on the ~~evice, or ~~~iay'be ii:npregnatecl cail t[le surfaces o1`t:he device or witki.n pores on the device, a~.~n-iixed witli ttie const:itiwiit materials of the device, for exunple with a reSiii, to be released over time pc~ii contact with gastric s bsia~ices.
101511 7I'hi~ embodiment, as well as ativ ot[ier embodiment discussed herem, may be functional in Ã:lte fully giastric or in the transpyloric positÃon, a~id may or may f-iot .Ãnctucie an elemei-it desi4.~lied to spai7 the pyloriis. ALcorcl.ingly, z-itiz of ttie atorementiOr~~ed functions of thi.s or any other embod:irz~erits tz~ay be 4st:co-inplisheil wi.th. a ;h4si.-~e-mennory, locking or inflatable structure that is designed to reside l:iillv and. solelv witliiii the gastric slaace.
101521 In addition, when any of the embodiments described herein has a lcgckiilg capability (for ex.ample; by tising a stri~ig to enga;.~~ a connecting member witli a mating) cavity, an~.-l:'or by tisi~ig a stri~ig to coiiiiecx the connecting ~~~ember to a re-lease z~~e-mber S C1I tli-it asever:iitg of flie string causes. the device tc) lose its locked, 1~iilbous eonfigurati~r~), an alerting elc:Ãiieiit may be employed to detect a reduction in teiision ot'Ãhe ~5 [ockaitiz yÃ-rait~ ~iid to alert the Liser of y c17 ~i-iomaiv. in the embodiment depicted in FIGS.
1A61 E; ati alerting element may be eznlslol=ed. to moiiitor the tonsion of the string that causes connecting T3ie1I1b~.`i' 56 to cot#pl~.` wI[l:I mating GEivItG' 64, or to monitor the tension of the string that coliplea release menil7er 58 to connecting member 56. Similar ar:ran4~ements may~ be employed for all th~.s other embodimeiits of the invention described herein.
101531 More part:icttlarly, a reduction in string tension may be used as an indicator of a failure of ttie locking mecliaiiism of ttie device, and using) tecliriiclues similar to those described above with referetice to FIG. 27C, tliis.fiaalure may be reported to the patietiÃ: or to aÃtendn.ig, personnel to provide f.'or a rapid removal of the devic-e from the stoznach.

[0154I String Ãetisicsii in the string rnay be meastired :i~~ a ~~ariety- Ã:fl ways. for ex~~rs~l~l.c: bv=tt~~si~~ni~~Ã~ a ~;~ring cl~;ra~~er~t i~~ li~~~~ with the st~-it~g. so that two electrodes will come iiito cw.iÃact if the str.ing short~~~s, unexpectedly. This ytr.ifla shortening may generate a local si~rial, for ex.ample; a vibration or an acoustic sound, or mav be reported external11=, for example via radio-frequency communication.
101551 Stic-h o1emetit for detecting string teris~~~~ may be battery laowered;
wit:li a poaver sotÃrce havirt ;x a tisabli lifo that spans tlio entire duration of the implant, or mm~ be rechargeable, eiÃber through an endt~scnpieally-Mmided catheter izitr~~~iced in tile stomach of the patient or wirelu;sly, 5Liclx tletecticgii element also may be use(l to ensure that the 1.0 loc kin~~ ~triÃ-ia has been sufficiently deployed by c;atisiÃit) the device to provide a~~edback that the clovice has been f:zi1ly loaded c?T~ce tb~.~ 1ock. has conic under sufficiesit tesision.
[I}1561 ~~~e method of disease treatment of particular interest based oii a clovice according to the present inventiuii is the release of insulin, achieved 6y disposirigaZ fiisulin reservoir in the secotid occluda~-iiz member (for exatriple, an device 30, in second occluding I;? ~~~ember 34), whic-h becomes positioned in t:l~e, gastro-intestinal tn, ot after implantat:~on of Ãlteclevice. S~~ich a release of in;ulin z~~iay be c~~~i-itrolled ljassavely, f~br example, by choosing an orifice o:l`a certain size to control flow from the reservoir.ÃnÃo the o ter envi.t-onnaent, or nx~~~ ~e controlled actively, for example, m4sv be t:itziet1 by a time-controlled actuator as 1<.iioovn Ui the art, or may be actuated by one or iiiore s~tisors, for exaniIsle in response to the 20 detection of sL3~ar in tbe. gastro-irYtestinwil tract. In orYU embodiment, instiIirY rs~~~~ be released by having the c~~~~ or ziiore setisors actuate a punils. (ti another embodiment, release of insulin may be, actuated extra-corporeally, by the pat:~~tit, by a clinician or by an automatic device upon the wireless reception of certaili data f'rorz-i a sensor implanted in the body, for example, wheii sttgar level in a portion of the ii-iÃesÃitic exceeds a cortain level. In 25 still another embodi~~~~enÃ:, a feedback rnay be provided to the laaiiet7t or to attending pers~~inel that is related to t~~e, conditions causitig the release of i~~stiliti, and/or to tbe ~~~iozir:-gt and speed of'relea,e of the insulin.
~01571 Such ability to release insulin r~~ik-es a device ~ccortlinz to the pr~~ent:
inventirgii suitable tor the tr~.sattzient of obesity, diabetes and other diseases not only by 3 0 providiii;.y itisriliii or c?tl~~~~ compourid. in the gastro-intestinal tract; btit also throiigh tbe conibiriation of the ocoltiding action of t:lie, proximal ziiember and the release of tlie compound storecl in tl:ie device.
101581 ~~~re, particularly, diabetes may l~~ treated not otilv tlirough tt~e dispersioti, of Rasuli.r:t in the wastro-i.nÃesÃ.iiial tract Ãa, direct therapylytu ihtou~;h ti~ie conibilaafiiol:1 of i.rasulir-I disper4ic~i.i a.iid the slowed gastric en-iptzing causes bv tI-~e presetit device, ~%vhich retitices tl-ic requirement for isYstrlin ,atraply. (an indiret;t tlYC~~~py).
Di.abotes ni<iy also be treated by providing itisulin at the reqLiired intervals to patients that are eitt7er averse to other delivery met:liods (for example, that are averse to injections) or that ~~~e. non-comlal.ianà diic to inabiliÃ-y or lack of desire to maintain the required schedules.
101:591 Conversely, obesity ~~~av be treated by iise of tbe present devic-e lioà only by reducin9 fbotl eritrv itito tl~ie intestinal tract by th.c iriteri-iiitt.etit occluding ac:t.ion. oti tl~le pylo:rie valve aiid by reducing appetite due to the i'oe1in4.~ of satietv induced b1= having the present device reside in the stomach, but also by dispersing insulin in tlxu patient's ;,xastro-l.0 inteSÃinal traet, especially in the more morbid CaS~s of obeSity.
~01601 While the invention has been described in connection with tb ~~ above described embocliments, it is iiot intended to [imit the scope of the invention to the particiilar fariiiS set forth, biit on tizo eonÃraxy, it is intended to cover such alternatives, modificaÃiony, arzd equivaletiÃs as naay 'be iiielr~~ed within the scope of tt7e a~~~~~i-itiorz.
I;> Further, the scope of t:lie, present ~~iveiitioti fully encompasses c?t~~er embodiments that may become obvious to those skilled .Ãn the art af-icl tlie scope of Ã:lte present invention is lirnÃted only by the appeirded clainis.

Claims (63)

1. A device for intermittently obstructing a gastric opening, the device comprising:
a proximal member including a first occluding member and an apron member, and a distal member including a second occluding member connected to the proximal member with a tether, wherein the first occluding member is formable from an elongated, narrower configuration to a contracted, wider configuration, and wherein the apron member has a proximal open end surrounding the first occluding member and a distal closed end connected to the tether.

2. The device of claim 1, wherein the proximal end of the apron member is spaced from the first occluding member by an interstice.

3. The device of claim 1, wherein the first occluding member is formable from the elongated, narrower configuration to the contracted, wider configuration by injecting a substance within the first occluding member.

4. The device of claim 1, wherein the elongated, narrower configuration is a helical configuration having a plurality of turns, and wherein the contracted, wider configuration is formed by nesting the turns one adjacent to the other.

5. The device of claim 4, wherein the first occluding member is reversibly formable from the elongated, narrower configuration to the contracted, wider configuration.

6. The device of claim 4, wherein the first occluding member is formable from the elongated, narrower configuration to the contracted, wider configuration by causing a connecting member at a first end of the first occluding member to couple with a second end of the first occluding member.

7. The device of claim 6, wherein the connecting member is coupled to the second end by engaging the connecting member in a mating cavity at the second end.

8. The device of claim 6, wherein the connecting member is coupled to the second end by drawing distally a string connected to the connecting member.

9. The device of claim 8, wherein the string extends along the length of the device within a lumen extending from the first to the second occluding members through the tether, wherein the string is looped through the connecting member, and wherein the string is removable from the device after the connecting member has engaged the second end.

10. The device of claim 8, wherein the string comprises a portion having a first color different from a second color of a remainder of the string.

11. The device of claim 6, wherein the first end is reinforced by including of a reinforcing material in the first end having higher mechanical properties than the remainder of the first occluding member.

12. The device of claim 6, wherein the first occluding member is reversible from the contracted, wider configuration to the elongated, narrower configuration by severing the connecting member from the first end.

13. The device of claim 1, wherein the device is manufactured from a resilient plastic material.

14. The device of claim 1, wherein the apron member is reversible from surrounding the first occluding member to surrounding a proximal portion of the tether.

15. The device of claim 1, wherein the apron includes a proximal essentially cylindrical portion and a distal essentially conical portion connecting the proximal portion to the tether.

16. The device of claim 14, wherein the proximal portion and the distal portion have different wall thickness.

17. The device of claim 1, wherein the second occluding member includes an insert having a heavier weight that the remainder of the second occluding member.

18. The device of claim 1, wherein at least on of the first or second occluding members have a bulbous shape.

19. The device of claim 1, further comprising a lumen extending axially through the first occluding member, the tether, and the second occluding member.

20. The device of claim 1, wherein the device includes a compound elutable from the device into the gastro-intestinal tract.

21. The device of claim 20, wherein the compound is contained in a reservoir disposed in the second occluding member.

22. The device of claim 20, wherein the compound is disposed on an outer surface of the device.

23. The device of claim 20, wherein the therapeutic compound is insulin.

24. The device of claim 1, further comprising a locking mechanism coupled to occluding member and configured to maintain the first occluding member in its contracted configuration.

25. The device of claim 24, further comprising a sensor configured to confirm and/or detect the contracted configuration of the first occluding member.

26. The device of claim 25, wherein the sensor is configured to detect the contracted configuration via a modality selected from the group consisting of acoustic, ultrasonic, electrical, electromagnetic, optical (for instance, detecting changes in color, wavelength, frequency, etc.), chemical, and tension.

27. A method of treating a disease, the method comprising:

disposing a device in a patient's stomach, the device comprising, a proximal member including a first occluding member and an apron member, and a distal member including a second occluding member connected to the proximal member with a tether, wherein the apron member has a proximal open end surrounding the first occluding member and a distal closed end connected to the tether, and wherein movements of the stomach cause the device to intermittently obstruct a gastric opening by causing the apron member to become intermittently disposed against the gastric opening.

28. The method of claim 27, wherein the disease is one or more of obesity, hyperphagia, or dyslipidemia.

29. the method of claim 27, wherein the disease is one or more of Prader Willi syndrome, Froelich's syndrome, Cohen syndrome, Summit syndrome, Alstrom syndrome, Borjesen syndrome, Bardet-Biedl syndrome, or hyperlipoproteinemia, types I, II, III, and IV.

30. The method of claim 27, wherein the device is disposed in the patient's stomach by introducing the device in the patient's stomach in an elongated, narrower configuration, and by forming the first occluding member from the elongated, narrower configuration to a contracted, wider configuration.

31. The method of claim 27, further comprising the step of dispersing a compound from the device into the patient's gastro-intestinal tract.

32. The method of claim 31, wherein dispersing the compound comprises dispersing the compound from a reservoir contained in the device.

33. The method of claim 32, wherein dispersing the compound comprises dispersing the compound from a reservoir contained in the distal member.

34. The method of claim 31, wherein the compound is disposed on an outer surface of the device.

35. The method of claim 31, wherien the compound is insulin.

36. The method of claim 27, further comprising reconfiguring the first occluding member into a contracted, wider configuration within the apron member.

37. The method of claim 36, further comprising locking the first occluding member into its contracted configuration such that passage through the gastric opening in inhibited by the first occluding member.

38. The method of claim 37, further comprising confirming the contracted configuration of the first occluding member by visual confirmation.

39. The method of claim 37, further comprising confirming the contracted configuration of the first occluding member by a sensor configured to detect the contracted configuration via a modality selected from the group consisting of acoustic, ultrasonic, electrical, electromagnetic, optical (for instance, detecting changes in color, wavelength, frequency, etc.), chemical, and tension.

40. A method of treating diabetes, the method comprising:
disposing a device in a patient's stomach, the device comprising, a proximal member including a first occluding member and an apron member, and a distal member including a second occluding member connected to the proximal member with a tether, wherein the apron member has a proximal open end surrounding the first occluding member and a distal closed end connected to the tether, and wherein movements of the stomach cause the device to intermittently obstruct a gastric opening by causing the apron member to become intermittently disposed against the gastric opening; and dispersing insulin from the device into the patient's gastro-intestinal tract.

41. The method of claim 40, further comprising the step of managing glucose peaks by configuring the proximal member to slow gastric emptying to predetermined rations.

42. The method of claim 40, wherein dispersing the insulin comprises dispersing the insulin from a reservoir included in the device.

43. The method of claim 40, wherein dispersing the insulin comprises dispersing the insulin from a reservoir included in the distal member.

44. The method of claim 40, wherein dispersing the insulin from the device comprises eluting the insulin from a surface of the device.

45. The method of claim 40, wherein dispersing the insulin comprises dispersing the insulin passively.

46. The method of claim 40, wherein dispersing the insulin comprises dispersing the insulin by actuating an insulin dispersing system.

47. The method of claim 46, wherein the insulin dispersing system is a pump.

48. The method of claim 46, wherein the insulin dispersing system is actuated in response to detecting by the device of a predetermined condition.

49. The method of claim 48, wherein the predetermined condition comprises one or more of a carbohydrate level, a fat level, and a sugar level.

50. The method of claim 48, further providing the step of providing a feedback signal to the patient or to a clinician.

51. The method of claim 50, wherein the feedback signal provides a feedback on one or more of the predetermined condition and of an amount of dispersed insulin.

52. A combination method of treating obesity, the method comprising:
disposing a device in a patient's stomach, the device comprising, a proximal member including a first occluding member and an apron member, and a distal member including a second occluding member connected to the proximal member with a tether, wherein the apron member has a proximal open end surrounding the first occluding member and a distal closed end connected to the tether, and wherein movements of the stomach cause the device to intermittently obstruct a gastric opening by causing the apron member to become intermittently disposed against the gastric opening; and dispersing insulin from the device into the patient's gastro-intestinal tract.

53. The method of claim 52, further comprising the step of managing patient weight by configuring the proximal member to slow gastric emptying to predetermined ratios.

54. The method of claim 52, wherein dispersing the insulin comprises dispersing the insulin from a reservoir included in the device.

55. The method of claim 52, wherein dispersing the insulin comprises dispersing the insulin from a reservoir included in the distal member.

56. The method of claim 52, wherein dispersing the insulin comprises dispersing the insulin passively to reduce appetite of the patient.

57. The method of claim 52, wherein dispersing the insulin comprises dispersing the insulin by actuating an insulin dispersing system.

58. The method of claim 57, wherein the insulin dispersing system is a pump.

59. The method of claim 57, wherein the insulin dispersing system is time-actuated.

60. The method of claim 57, wherein the insulin dispersing system is actuated in response to detection by the device of a predetermined condition.

61. The method of claim 60, wherein the predetermined condition comprises one or more of a carbohydrate level, a fat level, and a sugar level.

62. The method of claim 60, further providing the step of providing a feedback signal to the patient or to a clinician.

63. The method of claim 62, wherein the feedback signal provides a feedback on one or more of the predetermined condition and of an amount of dispersed insulin.