CA2134090C

CA2134090C - Esophageal stent and delivery tool

Info

Publication number: CA2134090C
Application number: CA002134090A
Authority: CA
Inventors: Liann M. Johnson; Richard J. Thompson; John A. Scholl
Original assignee: Schneider USA Inc
Current assignee: Schneider USA Inc
Priority date: 1992-05-08
Filing date: 1993-03-10
Publication date: 1997-03-25
Anticipated expiration: 2013-03-10
Also published as: US5876448A; EP0888758B1; AU1905397A; JPH07502673A; EP0888758A2; EP0888758A3; US5645559A; AU678350B2; EP0639958A1; WO1993022986A1; AU3789793A; ATE247435T1; DE69333161D1; DE9390115U1; CA2134090A1; JP2660101B2; AU693054B2; DE69333161T2

Abstract

A radially self-expanding stent (90) particularly suited for treating esophageal strictures, includes a medial region (92) and proximal and distal cuffs (94, 96) having diameters greater than the medial region (92) diameter when the stent (90) is in the re-laxed state. A silicone coating circumscribes the medial region (92), but the cuffs (94, 96) are not coated and retain their open weave construction. As a result, the cuffs (94, 96) remain particularly well suited to immediately contact esophageal wall tissue and resist stent migration, while the silicone coated medial region (92) provides a barrier to tumor ingrowth, and has an enhanced radial restoring force to maintain an open passageway in the esophagus. A deployment device (16) for the stent (90) includes an interior catheter (26) surrounded by the stent (90) and having an esophageal dilation feature (28), along with an exterior catheter (18) that radially compresses the stent (90). A low durometer sleeve (54), fixed to the interior tube (26) and in surface engagement with the compressed stent (90), tends to fix the axial position of the stent (90) relative to the interior catheter (26) whenever the exterior catheter (18) is moved axially relative to the inner catheter (26). Consequently, precision in stent placement and the abili-ty to recapture a partially deployed stent are enhanced.

Description

~jO 93/22986 PCl'~llS93/0~ 966 E~OPHAGEAL ~TBNT AND DISLIVERY !rOOL
i3Ae~KuuNu OF THE INVENTION
The present invention relates to body implantable treatment devices, and more particularly 5 to stents and other prostheses intènded for fixation in body lumens PapeciAlly including the esophagus.
Carcinomas in the esophagus lead to progressive dysphagia, i.e. difficulty in swallowing, and the inability to swallow liquids in the most severe lo cases. While surgical removal is sometimes effective, the majority of patients have tumors that can not be surgically removed. Repeated dilations of the esophagus provide only` temporary relief.
Difficult or refractory cases often are treated 15 by intubation using rigid plastic prostheses, or laser therapy with an Nd:YAG laser. These techniques, while often effective, have disadvantages. Rigid plastic protheses are large, for example having a diameter of 10-12 mm and larger 20 (25-29 mm) outer end flanges. Pl~- L of rigid plastic stents i8 traumatic, and too frequently causes perforation of the ~coph~e~l wall. These protheses further are subject to migration, obstruction with food or tumor ingrowth, and late 25 pressure necrosis.
Laser therapy is expensive, typically requiring several treatment sessions. Tumor re~uLL~i-ce is frequent, in the range of 30-40 percent. 5-~ C..c:~
tumors, and certain pulmonary and breast tumors 30 causing dysphagia by esophageal . ~ssion, can not be treated by laser therapy.
The search for a more suitable ~ru~LIIcsis has lead to experiments with Gianturco stents, also known as Z-stents. U.S. Patent No. 4,800,882 tGianturco) _ _ _ W093/22986 - PCr/US93/01966 ~
~ ~4Q~a de6cribes such a device employed as an ~duv..F_ular stent. Such stents for the esv~lla~us have been constructed of o . 018 inch stainless steel wire, and provided with a ci 1 i cnnP cover to inhibit tumor 5 ingrowth. It was found necQccAry, however, to provide a distal c~ l; c~ne bumper to prevent trauma to the Psoph~geAl mucosa.
Self-PYr~n~l;n~ mesh 6tents al60 have been c~ncidPred for use as Pcv~hAgP~ vDLl.esQs. U.S.
10 Patent No. 4,655,771 (Wallsten) discloses a mesh ctent as a flexible tubular braided ~LLU~;LUre formed of hPlicAlly wound thread elements. Mesh stents appear unlikely to lead to ~, ennu~-: necrosis of the QCophi~PAl wall. With its inherent pliability the 15 mesh stent, as compared to a rigid plastic stent, is insertable with much less trauma to the patient.
Further, the stent can mold itself to and firmly fix itself against the esophageal wall, to resist - mlgratlon. However, the stent is subject to tumor 20 ingrowth because of the spaces between adjacent f ~ L~ .
A further ~l;ff;cl~lty with self-PYrAn~lin~ stents, conrPrnc their ~ccurate placement and deployment.
Typically a tube surrounds the self-PYr~n~lin~ stent 25 and radially compresses the stent into a reduced-radius delivery conf iguration . With the stent po6itioned at a treatment site, the outer tube is axially withdrawn, permitting the stent to radially self-expand. However, the larger size of an 30 esophageal stent (as compared to biliary and vascular applications, for example) gives rise to substantial friction at the stent/outer tubing interface. As a result, it is dif f icult to precisely maintain the position of the stent during deployment, and 2 ~ 34090 practically impossible to retract the stent after partial deployment .
It is desirable to provide a radially self-expanding stent including a freely radially self~ n~ing fixation region in combination with a barrier reg~on to inhibit tumor ingrowth. An esophageal prostheses is deployable with reduced trauma to the patient, has more resistance to migration, and provides a barrier to tumor ingrowth as effective as conventional rigid plastic prostheses The invention provides a device for fixation in a body lumen, including: a tubular stent of open weave construction having an axial length and a predetermined normal configuration and being radially compressible to a reduced-radius configuration to facilitate an axial insertion of the ~.
stent into a body lumen for delivery to a treatment site within the body lumen; and a continuous elastomeric film formed axially along the stent and having an axial length, said rontinl~7us film circumscribing the stent over substantially the entirety of said axial length to def ine a barrier region of the stent to substantially prevent growth of tissue through the stent along the barrier region, said axial length of Eaid film being at least about one-third the a~ial length of the stent; and wherein a portion oi the open weave construction of the stent is substAnti~l ly free of the continuous film to provide a fixation region of the stent for positively fixing the stent within the body lumen at the treatment site, by radial expansion of the stent into a surface engagement with a tissue wall segment defining the body lumen.

B

The invention also provides a device for fixation in a body lumen, including: a flexible tubular stent having a predetermined normal conf iguration and being radially elastically compressible responsive tQ the application of an external force to a reduced-radius configuration to facilitate an axlal insertion of the stent into a body lumen for delivery to a selected treatment site in the body lumen; said stent, following removal of said external force, tending to radially self-expand into a ~surface engagement with a tissue wall segment defining the body lumen, thereby to fix the stent within the body lumen; and an elastically deformable reinforcement sleeve means integral with the stent, disposed axially along the st~ent and substantially surrounding the stent over a reinforced region of the stent, said reinforced region requiring at least one hour to return to the normal configuration after removal of the external force; wherein a portion of the stent is substantially free of the reinforcement means to pr~vide a fixation region of the stent, and the fixation reglon, as compared to the reinforced region, tends to radially self-expand with less restoring force upon removal of said external f orce .
The inve~tion further provides a device ~or fixation in a body lumen, including: a tubular stent of open weave construction having a predetermined normal conf iguration and being radially compressible to a reduced-radius configuration to facilitate an axial insertion of the stent into a body lumen for delivery to a treatment site within the body lumen;
and a continuous elastomeric film formed axially along the stent and having an axial length, said -~ln~;nll~us film B

.. . .. . .. . . . .

circumscribing the stent over su'ost~nt;~lly the entirety of said axial length to def ine a barrier region of the stent to substantially prevent growth of tissue through the stent along the barrier region; wherein a portion of the stent is subst~nt;~lly free of the rf~ntlnllr/us film to provide a fixation reyion of the stent for positively fixing the stent within the body lumen at the treatment site, by radial expansion of the stent into a surface en-gagement with a tissue wall segment rlPf;n;nr the body lumen; and wherein the barrier region and the fixation region have respective first and second diameters when the stent is in the predetermined normal configuration, with said first diameter being less than the second diameter.
The preferred stent comprises a mesh formed of braided helical strands. The fixation region can comprise a proximal cuff and a distal cuff, with the barrier region being a medial sleeve of the stent positioned between the cuf f 8 .
Also, the barrier region preferably has a diameter less than the fixation region diameter when the stent is in its normal or relaxed configuration. A preferred material for the film is silicone. When properly controlled as to thickness, the silicone film provides a gradual self-expansion. More particularly, while the fixation region self-expands virtually instantaneously upon release of the stent, the medial barrier region, upon encountering a-tumor or other striction, can take up to 2~ hours to achieve a substantially complete radial self-expansion against the tumor This feature is particularly advantageous in connection with treating esophageal strictures, where - 4a -6~680-766 B

tlssue at the strlcture may be severely weakened, and where normal convulslons of the esophagus tend to cause stent mlgratlon. More partlcularly, the rapldly ~r~qn~11ng flxatlon reglons GOntact normal esophageal tlssue on elther slde of a strlcture, and are sufflclently pllable to ad~ust to esophageal convulslons. Meanwhlle, the barrler reglon of the stent experlences a gradual radlal expanslon, thus causlng mlnlmal dlsruptlon to tlssue along the strlcture.
IN THE DRAWINGS
For a ~urther appreclatlon of the above and other features and advantages, reference 18 made to the followlng detalled descrlptlon and to the drawlngs, ln whlch~
Flgure 1 18 a slde elevatlonal vlew o~ a stent deployment devl ce~
Flgure 2 18 an end elevatlon of the devlce~
Flgure 3 18 a sectlonal vlew taken along the llne 3-3 ln Flgure 2;
Flgure 4 18 a slde elevatlon of a stent ln a relaxed conf lgurat lon ~
Flgures 5-8 are sectlonal vlews slmllar to Flgure 3, showlng the devlce at several stages of deploylng a radlally self-~rr-qn~lln~ stent~
Flgure 9 18 a sectlonal vlew taken along the llne 8-8 ln Flgure 3, showlng a stent retalnlng layer~
Flgure 10 18 a sectlonal vlew slm~lar to Flgure 9, but showlng an alternatlve ~ ' ~lr ' devlce utlllzlng stent retalnlng strlps ln lleu o~ the retalnlng layer shown ln Flgure 9~
Flgure 11 18 a schematlc vlew o~ an esophageal '~A 64680-766 2 ~ 34(~90 prosthesis constructed ln accordance wlth the present lnvent lon;
Flgures 12 and 13 lllustrate alternatlve brald angle conf lgurat lons ~or sel~ Rr~n~l 1 n~ prostheses ~
Flgure 14 18 a slde elevatlonal showlng a mandrel used ln formlng the prosthesls of Flgure 11T
Flgure 15 schematlcally lllustrates the prostheses of Flgure ll ln an esophagus, a short tlme after lts deployment 1 Flgure 16 schematlcally lllustrates the prosthesls one day after lts deployment ~ and Flgure 17 lllustrates an alternatlve prostheses constructed accordlng to the present lnventlon, and deployed ln an esophagus, wlth a dlstal end o~ the prostheses protrudlng lnto the stomach.
DETAILED b~ LON OF THE ~ ;L) BM~ODIMENTS
Turnlng now to the drawlngs, there ls shown ln Flgure 1 a deployment devlce 16 ~or dellvering a stent or other prostheses to an lntended flRatlon ~) 93/22986 2 1 3 ~ ~ ~ Q PCl`/US93~03966 Figure 3 is a sect i on~ 1 view tsken along the line 3-3 ln Figure 2;
Figure 4 i8 a side elevation of ~stent in a relaxed configuration;
Figure6 5-8 are sectional views similar to Figure 3, showing the device at l:everal stages of deploying a radially self-oYp~n~lin~ stent;
Figure 9 is a sectional view taken along the line 8-8 in Figure 3, showing a gtent ret:~inin~
layer:
Figure lo is a sectional view similar to Figure 9, but showing an alternative ~ device utilizing stent retaining strips in lieu of the rotA i n 1 n~ layer shown in Figure 9;
Figure 11 is a schematic view of an esophageal prosthesis cc,l,DLLu~:Led in accordance with the present invention Figures 12 and 13 illustrate alternative braid angle configurations for self-oYp~n~l~n~ prostheses;
Figure 14 is a side elevational showing a mandrel used in forming the prosthesis of Figure 11:
Figure 15 schematically illustrates the prostheses of Figure 11 in an esophagus, a short time after its deployment Figure 16 schematically illustrates the prosthesis one day after its deployment; and Figure 17 illustrates an alternative pl--,Lheses constructed according to the present invention, and deployed in an esophagus, with a distal end of the prostheses protruding into the stomach.
n~ATr,~n DESCRIPTION OF THE ~K~ ;U ~r,~uL~
Turning now to the drawings, there is shown in Figure 1 a deployment device 16 for delivering a stent or other prostheses to an intended fixation WO 93/22986 PCr/US93/01966 ~
213~090 A
location within a body cavity, and then controllably releasing the stent for radial self-expansion to a fixation within the body cavity.
The device includes an elongate exterior 5 catheter or tubing 18 ~:u,i~Lu~;Led of a bi~ _tible polymer, e.g. polypropylene, FEP or Teflon, with an outside diameter of about 12 mm or less. A central lumen 20 runs the length of catheter 18. On the outside of catheter 18 are visible r-rkinqs: 22 designating cm. When using the device, e.g. in deploying a radially self-~Yp~nrlinq prostheses within the esophagus, a physician can determine the extent of insertion into the esophagus based upon these markings. Throughout deployment, the proximal end of exterior rAth~t~r 18 remains outside the patient. A
hub or handle 24 at the proximal end of the exterior catheter, facilitates manipulation of exterior catheter 18 by hand.
An interior catheter or tubing 26 runs through lumen 20, contained within the exterior catheter.
Interior catheter 26 has an outside diameter of approximately 6 mm or less, and is constructed of a biocompatible polymer, e.g. polypropylene, FEP, Hytrel or nylon.
At the distal end of interior catheter 26 is a distal tip 28. The distal tip i8 flexible, yet sufficiently rigid to be self ~ ~uLLing rather than pliable when encountering tissue. As a result, distal tip 28 can be used to dilate the esophagus along regions where a tumor or other stricture is present. Over the majority of its length, distal tip 28 has a ~ r substantially equal to the interior tubing diameter, with a distal converging end 30 formed as part of the tip.

~p 93~229X6 ~ ~ 3 ~ ~ 9 ~ PCIJUS9~JD1966 . . .

A proximal region 32 of interior catheter 26 extends proximally beyond hub 24. Visible ~-rkln~:
on the outer surface of catheter 26 define three adjacent segments of the proximal region, as 5 indicated at 34, 36 and 38, respectively. These segments can be different colors if desired, to enhance their recognition. These s- ~s, and more particularly the position of hub 24 along them, indicate the axial position of exterior catheter 18 10 relative to interior catheter 26. The segments f&rther indicate the stages of stent deploymeDt, as is later explained.
At the proximal end of interior catheter 26 is a hub or handle 40, which facilitates ~-nir--lation of 15 the interior catheter by hand . A lumen 4 2 t Figure 3 ) runs the length of interior catheter 26, to a. te a guidewire 44.
Figure 3 reveals further features of interior catheter 26, including a distal enlargement feature 20 46 positioned just proximally of tip 28. Enlargement feature 46 is cylindrical, and includes a mid-portion or medial region 48 having an outside diameter of about 11-12 mm, substantially equal to the diameter of lumen 20. Thus the enlargement feature is in 25 surface elly~g~ ~ with exterior catheter 18 as shown in Figure 3, and can slide relative to the exterior catheter .
Enlargement feature 46 also includes proximal and distal transition regions at 50 and 52, 30 respectively. Distal transition region 52 diverges proximally from the distal tip to the mid-portion of the enlargement feature. The proximal transition region Cullvt:Ly~s proximally from the mid-portion to the interior catheter.

WO 93/22986 PCr/US93/01966 ~
2~109~
ID
An annular restraining sleeve 54 .~UL~VUI.~8 a distal region 56 of the interior catheter. The sleeve iB formed by wrapping double sided adhesive tape around the interior catheter 80 that the sleeve adheres to the inner catheter and also exhibits a tackiness over its exterior gurface. R~Aiop~
markers 58, 60, 62 and 64 :.ULLVUlld the sleeve. These markers can be 2iULLVUllded by sleeve 54 if desired.
Surrounding sleeve 54 is a radially self-~Yr5`nA 1 mJ stent 66 . The stent preferably is of open weave or mesh construction, formed of multiple hPlic~lly wound strands or filaments of a flexible material such as body compatible stainle6s steel.
The durometer of sleeve 54 is substantially less than the durometer of catheters 18 and 26. R~ inin~
sleeve 54 is sized such that whenever exterior catheter 18 radially ~ es6es stent 66, the catheter also is pressing the stent into a surface engagement with the retaining sleeve, to the point of at least ~lightly elastically deforming thQ sleQvQ.
As a rQsult, friction bQtwQQn the stent and sleeve 54 ~u`v La~tially exceeds friction between the stent and the interior surface of catheter 18. Given the length and positioning of retaining sleeve 54, stent 66 when ~ :es~ed contacts the sleeve over its entire axial length. In any event, the stent should contact sleeve 54 over at least its entire medial region. Thus, there is no tendency in the stent to travel with exterior cathQter 18 as this catheter movQs axially rQlativQ to catheter 26. Rather, the stQnt rQmains Qssentially fixed in thQ axial direction rQlativQ to cathQter 26. As a result, the axial position of intQrior cathQter 26 servQs as a rQliable indication of thQ location of stent 66, not 93/22986 ~1 3~ ~ ~ O PCr/US93/01966 ~0 ~, only before deployment, but thLvu~l.vuL most of the deployment prvc~duL~.
An adhesive layer 68 on the exterior surface of retaining sleeve 54 of course further insures that 5 stent 66 remains axially fixed relative to the interior catheter. It has been found that adheslve is not necessary when deploying a stent of open weave or mesh con6truction over its entire length.
Friction due to the lower durometer of the retaining 10 sleeve, alone, has been found sufficient to anchor the stent. However, when a silicone or other polymeric film covers the 6tent medial region, the adhesive is a key factor, in combination with the low durometer, in retaining the stent during external 15 catheter withdrawal.
As shown in Figure 3, stent 66 is in a L~-lu~ed radius and axially elongated configuration. The stent is ~ised into this conf iguration due to the external radial force provided by exterior 20 catheter 18. When the exterior catheter is withdrawn, thus removing the external force, stent 66 assumes a normal or relaxed conf iguration shown 6chematically in Figure 4. More particularly, a medial region 70 of the stent assumes a diameter of 25 about 20 mm, and opposite end regions 72 and 74 of the stent assume a diameter of about 30 mm.
Hub 24 is fixed to exterior catheter 18, and has an opening to ~ te interior catheter 26 such that the interior catheter i5 slidable axially 30 relative to hub 24. Hub 40 has an opening formed therethrough, to ~ ' te guidewire 44.
An annular sleeve detent 76 ~.ULLVUlldS the proximal region of interior catheter 26, between hubs 24 and 40. When positioned as shown in Figure 1, WO 93/22986 ' PCr/US93/01966 ~
2~34090 retaining sleeve 76 ~-ULL~ d6 the interior aatheter and abuts the hubs to prevent any ~.uL,,iLa..Lial v~ - L of the interior catheter axially relative to exterior catheter 18. Sleeve 76 thu6 functions a~ a 5 safety detent, preventing premature deployment of the stent. Sleeve detent 76 has a lengthwise slit, and thus is easily removed from proximal region 32 for stent deployment.
Deployment of stent 66 within the corhAg~c is 10 cr)ncifi~red appropriate when a tumor, lesion or other ~tricture has constricted the ~cO~h ~A l passageway to a diameter less than about 15 mm. This Le~Lesent6 a severe constriction in light of the normal p~ A.j~ ..y diameter of about 22 mm. Deployment 15 begins by oral insertion and positioning of guidewire 44, using an elldos.~ e (not shown) in a manner well known in connection with treating not only the esophagus but other body lumens, e . g . arteries . The guidewire catheter has a diameter of about 0 . 035-20 0. 042 inches. Once the guidewire has been properlypositioned, the endoscope is withdrawn.
Next, deployment device 16, including stent 66 radially ~ _,2ssed as shown in Figure 3, is inserted over guidewire 44 and thus is directed toward the 25 desired t Leai L location as it is moved distally.
Eventually, distal tip 28 of the device encounters the esophageal stricture. At this point, the deployment device is firmly but carefully moved further in the distal direction, to utilize distal 30 tip 28 to dilate the region of the stricture. Once the distal tip has entered the region, distal transition region 52 and mid-portion 48 of the enlargement feature are used to further dilate the region of the 6tricture, eventually to the point ~093/22986 213~D PC~/US93~0~966 ~3 where the distal region of exterior catheter 18 i8 pa6sed through the region of the stricture. Thus, according to one feature of the present invention, the stent delivery device also dilates the region of 5 the esophageal stricture and no separate dilating tool i8 required.
With the distal end of the exterior catheter past the stricture, stent deployment is initiated.
More particularly, with interior catheter 26 held 10 substantially fixed, hub 24 is --n1r~llAted by hand to withdraw exterior catheter 18 in the proximal direction. When hub 24 encounters segments 34 along the proximal region 32 of the interior catheter, the distal end of the exterior catheter is near the 15 distal end of stent 66, meaning that deployment is about to begin. Before further withdrawal of the exterior catheter, it is advisable to re-examine the s~ent position, to insure that medial region 70 of the stent is aligned with the stricture, represented 20 in Figure 5 by a tumor 78 in ~ Al wall tissue 80. With stent 66 properly aligned, exterior catheter 18 is withdrawn proximally until hub 24 encounters segment 3 6 . As shown in Figure 5, by the time the hub encounters segment 36, distal end region 25 72 of stent 66 is released from the exterior catheter and radially self-expands until it encounters tissue 80 .
Figure 6 illustrates further withdrawal of exterior catheter 66, to the point where hub 24 30 encounters marked segment 38. This cc,LL~ u"~s to release of stent 66 over its distal region and medial region, i.e. roughly two-thirds deployment. one of the advantages of retaining sleeve 54 is that even at this advanced stage, it remains possible to r~cover W093/22986 ~ PCr/US93/01966 ~
~134~90 Pf or retract 6tent 66 by moving eYteriOr catheter 18 ,~ distally relative to interior catheter 26. Such stent ~ LuL~ occasionally i8 nec es~Ary, in order to reposition stent 66 relative to the P~ophA~PAl 5 stricture. More generally, the stent i8 virtually always retrsctable, even when a majority of lts axial length is released . With the stent retA i n i n~ means of the present invention, stents have been found to be retractable after up to 80 percent deployment.
Figure 7 illustrates full withdrawal of exterior catheter 18 to completely release stent 66, ~U.L~ ;n~ to proximal ~ l. to the point where hub 24 i6 at the proximal end of proximal segment 38.
Stent 66 is radially PyrAnrlpd (and axially shortened) 15 over its entire length, although not ~ 1PC1 to its normal, relaxed configuration. Rather, the stent expands only until the constraining force of esophageal tissue 80 and the L. ;n;n~ residual force in the 6tent reach an equilibrium. In the 20 eq~; 1 ;hrium state, stent 66 has a diameter substantially larger than the diameter of enlargement feature 46, in particular its mid-portion.
Accordingly, interior catheter 26 can be withdrawn proximally through the PYrAn~l~cl stent. Proximal 25 transition region 50 further insures against the possibility of enlargement feature 46 being caught during attempted withdrawal, either by stent 66 or a E;tricture in the esophagus. However, as a precaution against this event, the physician can advance 30 exterior tubing 18 distally through the deployed stent until its distal end once again ~,uLl~,ul.ds the enlargement feature as shown in Figure 1.
Figure 8 illustrates a proximal withdrawal of enlargement feature 46 and dist~l tip 28 pa~t stent ~093/22986 213~ PCr/US93/01966 66. Withdrawal of the delivery tool is followed by withdrawal of guidewire 44, unless the guidewire is retained for guiding another tool, e.g. an ~n~los~
into the esophagus.
Figure 9 illustrates the radial ~ ssion of stent 66 by exterior catheter 18 to press the stent into surface e~y~g~ - L with restraining sleeve 54.
Figure 10 is a view similar to Figure 9, but showing an alternative deployment device in which several strips 82, elongate in the axial direction, are spaced apart angularly in an array about an interior catheter 84. Like sleeve 54, the strips are ao~ u.:Led of a material having a substantially lower durometer than the catheter6. The strips are secured to the interior catheter and, if desired, are provided with adhesive coatings along their radially outward 8u, races, as indicated at 86 .
While stent 66 is satisfactory in many respects, it is unsuitable for treatment of certain cancerous 20 tissue in the ~C.,~.hi~ c, Such tissue is not as strong as healthy ~sv~hE.~al tissue, and thus is sub; ect to rupture or other damage f rom an excessively rapid and forceful expansion of a conventional open weave stent . The stent is sub; ect to tumor ingrowth due to its open weave ~UII~ L- U~.: Lion .
Further, pûints or edges at the opposite ends of the stent may perforate the ~s~rh~G~l wall.
A prostheses or stent 90, shown in Figure 11, is cu~.~L-u~Led to address all of these ~ . Like stent 66, stent 90 is of mesh or open weave construction, comprised of multiple braided and `' h~licllly wound strands. Stent 90 has a medial sleeve or region 92, a distal cuff 94 and proximal cuff 96. The proximal and distal ends of the stent WO 93/22986 PCr/lJS93/01966 21~9~
are directed radially inward, as indicated at 98 and 100. When stent 90 is in its relaxed or normal conf iguration as shown in the f igure, medial region 92 has a diameter of about 20 mm, and the cuffs have a diameter of about 30 mm. The fili LB forming the stent, preferably of a body compatible stainless steel, are about 0 . 22 mm or less in diameter.
While cuffs 94 and 96 are open, medial region 92 is circumscribed, i.e. completely covered, with a continuous polymeric film, preferably silicone. The silicone film is applied by dip coating of stent 90, in which event the f ilm initially covers one of the cuffs, and i8 removed from that cuff prior to using the stent. The preferred th;C~n~cc of the silicone film is in the range of 0.003 - 0.01 inches tO.075 -0 . 25 mm), and is controlled primarily by the number of dip coating applications. More specifically, from three to f ive dip coatings result in a thicknes6 within the preferred range.
The silicone film i8 elastic, and thus is radially self-~Yr~n~lin~ like the 1~ inrl~r of stent go. However, the silicone reinforces the medial region such that it has a much greater restoring force than the open weave portions of the stent. In particular, while cuffs 94 and 96 tend to recover virtually instant~n~ol~Cl y from a radially _s6ed configuration, a tumor would inhibit their recovery.
Medial region 92 recovers against a tumor, although it has been observed to take 24 hours for recovery.
It has been found that the L~Cu~e:ly rate of the medial region 92 can be controlled by controlling the thicknr~cc of the silicone film.
The gradual lecu~ely rate of the medial region against tumors affords several advantages which make ~0 93/22986 213 ~ O ~ ~ PCr~US93J01966 stent 90 particularly well suited for treating esophageal strictures. Certain advantages arise from the coated medial region itself, and other advantages ariae from the combination of the medial region with 5 cuffs 94 and 96. Conaidered alone, medial region 92 provides an effective barrier to tissue ingrowth, because of the continuous silicone film. The gradual recovery of medial sleeve 92, from the radially , ~ ssed state when the stent is deployed, 10 substantially reduces the chance that w ~koned cancerous tissue will be harmed during stent radial self-expansion. While a recovery rate of about one hour would significantly reduce most of the risk, the ObSeLved L-::Cu~ rate of 24 hours is highly i5 preferred. A further advantage arises from the fact that the residual force along the medial region is greater than the residual force along the more rapidly DYrAntl; ng cuffs. As a result, the maximum radial dilating force is provided along that portion 20 of stent 90 aligned with the osophA~oAl stricture.
As mentioned above, cuffs 94 and 96 radially expand rapidly upon their release from a stent confining meana such as exterior catheter 18. Thus, the cuffs rapidly contact and reach equilibrium with 25 healthy tissue of the esophageal wall. ~jr7~
force in the cuffs at equilibrium is much le3s than the residual force along medial region 92. ~s a result, cuffs 94 and 96 readily conform to changes in the esophageal wall during swallowing and other 30 convulsions cf the esophagus. Thus, the cuf Es are particularly effective in resisting either proximal or distal migration the stent. The open weave Cu~ uuLion of the cuffs does not give rise to the problem of tumor ingrowth, since medial region 92 is -WO 93/22986 PCr/US93/01966 ~
2l~aso /~
aligned with the stricture, while the cuffs engage healthy tissue . t Yet another advantage of the silicone film is that it proYides reinfoLI ~ along medial region 5 92, enabling the stent to be c~D~Lu~;~ed with a reduced braid angle. The braid angle i6 ~ d~
based on the fllament incllne from the axial dimension of the stent. Figures 12 and 13 illustrate a high braid angle and a low braid angle, respectively. In each case, the stent is oriented with its axial length in the horizontal direction.
Heretofore, 90 degrees has been considered a lower practical limit for the braid angle of a mesh or open weave stent. Employing the silicone film, however, enables a re~llrt; r n of the braid angle to as low as 70 degrees, as illustrated in Figure 13. The advantage of a lower braid angle resides in the fact that the braid angle ~t~rm; n~l: the ratio of stent axial shortening to radial increase, as the stent self-expands. With a reduced braid angle, there is less axial shortening for a given radial expansion.
Due to the reduced axial l'drift", the stent can be more accurately positioned within body lumens during its deployment.
Figure 14 illustrates a mandrel 102 particularly well suited for forming stent 90. Mandrel 102 includes a central shank 104, enlargements 106 and 108 on opposite sides of the shank, and end portions 110 and 112. To form the stent, the individual fll, ~5 or strands are wound in helical fashion to form an open weave cylinder. The cylinder is placed upon mandrel 102 and heated to a temperature in the range of from about 800-1, 000 degrees F. The f~l ~8, when cooled, retain the shape of the 21 3409~
.
deployed wl~h a tool substantially ldentlcal to deployment devlce 16.
Thus, ln accordance wlth the present inventlon, a radlally self-~1rr~n~lln~ stent lncludes a barrler reglon clrcumscrlbed by a slllcone fllm to reduce tumor lngrowth, ln comblnation wlth a flxatlon reglon of open weave constructlon.
The stent 18 reslstant to mlgratlon and to tumor lngrowth, and can be conf lgured to recover gradually along lts barrler reglon after deployment, to mlnlmlze harm to weakened, cancerous t lssue . The devlce ~or deploylng the stent lncorporates a dllatlon tlp and a further dllatlon feature proxlmally of the tlp, to ellmlnate the need for a separate esophageal dllatlng tool. Durlng dellvery and deployment, the stent surrounds and 18 radlally compressed agalnst a low durometer stent restralnlng sleeve. Thls flxes the stent axlally wlth respect to an lnterlor catheter o~ the deployment devlce, for enhanced accuracy ln stent posltlonlng and ~nh~ncl~d ablllty to recover or retract a partlally deployed st ent .

-~ -- 1 9 rA~i 64680-766

Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE PROPERTY OR
PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A device for fixation in a body lumen, including:
a tubular stent of open weave construction having an axial length and a predetermined normal configuration and being radially compressible to a reduced-radius configuration to facilitate an axial insertion of the stent into a body lumen for delivery to a treatment site within the body lumen; and a continuous elastomeric film formed axially along the stent and having an axial length, said continuous film circumscribing the stent over substantially the entirety of said axial length to define a barrier region of the stent to substantially prevent growth of tissue through the stent along the barrier region, said axial length of said film being at least about one-third the axial length of the stent; and wherein a portion of the open weave construction of the stent is substantially free of the continuous film to provide a fixation region of the stent for positively fixing the stent within the body lumen at the treatment site, by radial expansion of the stent into a surface engagement with a tissue wall segment defining the body lumen.

2. The device of Claim 1 wherein:
the stent is elastic, tending to assume the reduced-radius configuration in response to the application of an external force, and tending to assume the normal configuration in the absence of the external force.

3. The device of Claim 2 wherein:
the film reinforces the stent along the barrier region.

4. The device of Claim 3 wherein:
the film is formed of silicone.

5. The device of Claim 3 wherein:
the fixation region of the stent tends to exert lower restoring force in its return toward the normal configuration, as compared to the barrier region of the stent, upon removal of the external force.

6. The device of Claim 5 wherein:
the barrier region requires at least one hour to return toward the normal configuration when encountering a tumor.

7. The device of Claim 2 wherein:
the stent comprises a mesh formed of braided helical strands.

8. The device of Claim 2 wherein:
a braid angle, defined as the angle between two intersecting helical strands and encompassing a longitudinal axis of the stent, is approximately 70 degrees.

9. The device of Claim 2 wherein:
said fixation region is comprised of a proximal cuff and a distal cuff, and the barrier region is comprised of a medial sleeve of the stent between the proximal and distal cuffs.

10. The device of Claim 9 wherein:
the stent is formed of braided helical strands, with opposite ends of the strands at proximal and distal ends of the stent bent radially inward.

11. The device of Claim 1 wherein:
the barrier region has a diameter less than the diameter of the fixation region when the stent is in the normal configuration.

12. The device of Claim 13 wherein:
said continuous film reinforces the stent along the barrier region.

13. A device for fixation in a body lumen, including:
a flexible tubular stent having a predetermined normal configuration and being radially elastically compressible responsive to the application of an external force to a reduced-radius configuration to facilitate an axial insertion of the stent into a body lumen for delivery to a selected treatment site in the body lumen; said stent, following removal of said external force, tending to radially self-expand into a surface engagement with a tissue wall segment defining the body lumen, thereby to fix the stent within the body lumen; and an elastically deformable reinforcement sleeve means integral with the stent, disposed axially along the stent and substantially surrounding the stent over a reinforced region of the stent, said reinforced region requiring at least one hour to return to the normal configuration after removal of the external force;
wherein a portion of the stent is substantially free of the reinforcement means to provide a fixation region of the stent, and the fixation region, as compared to the reinforced region, tends to radially self-expand with less restoring force upon removal of said external force.

14. The device of Claim 13 wherein:
the elastic reinforcing means comprises a polymeric film.

15. The device of Claim 14 wherein:
the polymeric film is a silicone film.

16. The device of Claim 13 wherein:
the fixation region is comprised of proximal and distal cuffs, and the reinforced region is comprised of a medial region of the stent between the proximal and distal cuffs.

17. The device of Claim 16 wherein:
the proximal and distal cuffs have diameters larger than the diameter of the medial region when the stent is in the normal configuration.

18. A device for fixation in a body lumen, including:
a tubular elastic stent of open weave construction having a predetermined normal configuration and being radially compressible to a reduced-radius configuration in response to the application of an external force to facilitate an axial insertion of the stent into a body lumen for delivery to a treatment site within the body lumen, and tending to assume the normal configuration in the absence of the external force; and a continuous elastic polymeric film formed axially along the stent and circumscribing the stent over a barrier region of the stent to substantially prevent growth of tissue through the stent along the barrier region, said film reinforcing the stent along the barrier region; and wherein a portion of the stent is substantially free of the continuous film to provide a fixation region of the stent for positively fixing the stent within the body lumen at the treatment site, by radial expansion of the stent into a surface engagement with a tissue wall segment defining the body lumen, with the fixation region of the stent tending to exert a lower restoring force in its return toward a normal configuration, as compared to the barrier region of the stent, upon removal of the external force.

19. A device for fixation in a body lumen, including:
a tubular elastic stent of open weave construction tending to assume a predetermined normal configuration in the absence of an external force and being radially compressible to a reduced-radius configuration in response to an application of the external force to facilitate an axial insertion of the stent into a body lumen for delivery to a treatment site within the body lumen; and a continuous elastomeric film formed axially along the stent and having an axial length, said continuous film circumscribing the stent over substantially the entirety of said axial length to define a barrier region of the stent to substantially prevent growth of tissue through the stent along the barrier region;

wherein a portion of the stent is substantially free of the continuous film to provide a fixation region of the stent for positively fixing the stent within the body lumen at the treatment site, by radial expansion of the stent into a surface engagement with a tissue wall segment defining the body lumen.

20. The device of claim 19 wherein:
said fixation region, as compared to the barrier region, tends to radially self-expand with less restoring force upon removal of the external force.

21. The device of claim 19 wherein:
said barrier region requires at least one hour to return to the predetermined normal configuration after removal of the external force.

22. The device of claim 19 wherein:
said tubular elastic stent has an axial length, and the axial length of the continuous elastomeric film is at least about one-third of the axial length of said tubular elastic stent.

23. A device for fixation in a body lumen, including:
a tubular stent of open weave construction having a predetermined normal configuration and being radially compressible to a reduced-radius configuration to facilitate an axial insertion of the stent into a body lumen for delivery to a treatment site within the body lumen; and a continuous elastomeric film formed axially along the stent and having an axial length, said continuous film circumscribing the stent over substantially the entirety of said axial length to define a barrier region of the stent to substantially prevent growth of tissue through the stent along the barrier region;
wherein a portion of the stent is substantially free of the continuous film to provide a fixation region of the stent for positively fixing the stent within the body lumen at the treatment site, by radial expansion of the stent into a surface engagement with a tissue wall segment defining the body lumen, and wherein the barrier region and the fixation region have respective first and second diameters when the stent is in the predetermined normal configuration, with said first diameter being less than the second diameter.

24. The device of claim 23 wherein:
said tubular stent has an axial length, and the axial length of the continuous elastomeric film is at least about one-third of the axial length of said tubular stent.

25. The device of claim 23 wherein:
said tubular stent is radially elastically compressible under an external force,and fixation region, as compared to the barrier region, tends to radially self-expand toward the predetermined normal configuration with less restoring force upon removal of the external force.

26. The device of claim 25 wherein:
said barrier region requires at least one hour to return to the predetermined normal configuration after removal of the external force.