CA2199956A1 - Permanent shape memory alloy stent - Google Patents
Permanent shape memory alloy stentInfo
- Publication number
- CA2199956A1 CA2199956A1 CA002199956A CA2199956A CA2199956A1 CA 2199956 A1 CA2199956 A1 CA 2199956A1 CA 002199956 A CA002199956 A CA 002199956A CA 2199956 A CA2199956 A CA 2199956A CA 2199956 A1 CA2199956 A1 CA 2199956A1
- Authority
- CA
- Canada
- Prior art keywords
- stent
- supporting device
- shape
- tissue
- tissue supporting
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
- A61F2210/0023—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/902—Method of implanting
- Y10S623/903—Blood vessel
Abstract
A permanent tissue supporting device, and a method for supporting tissue, wherein a stent-like member comprising a shape-memory alloy is permanently positioned to support the tissue of a tubular organ of a living body. The shape-memory alloy of the positioned stent-like member is in the martensitic state and exhibits a strain on a horizontal plateau of a stress-strain curve of the shape-memory alloy when permanently positioned in the tubular organ.
Description
wo 96/09020 PCTIUS95/12092 PERMANE~ SHAPE MEMORY ALLOY STENT
~ rleld of the Invention The invention relates to tissue sup~ g devices (stents), preferably vascular stents for lcp~;--ng blood vessels, and more particularly, to non-S l~.no~ble devices which will ~ ~ nf ntly su~.l a dilated stenn~ic of atubular organ (hollow viscus) such as a blood vesse~.
- -k~, ~u--d of the I..~.h.on In the past, permanent or biodegrad~hle devices have been developed for i...pl~ht~l;nn within a body passageway to ~..Aint~;n vascular patency. These 10 devices are typically d~ lr. ;7~d by the ability of such an intravascular device to be enlarged radially after having been introduced ~,~;u~; n~!-cly, to be t.,.n~. ~d t~n~ll...,in~lly, and to be po~itinned in a desired loc~inn. These devices are eitha r ~l~Anded ~npcl~ni~?~lly~ such as by the e .lMn~:nn of a .,~dl~l positinnf~d inside the device, or are capable of lc~ ;n~ stored energy 15 to expand Ihr--.selves upon actu~tion within the body.
U.S. Patent Nos. 4,739,762, 4,776,337 and 4,733,665 ~ ose P-l-Andahle and deformable intr~ min~l vascular grafts in the form of thin-walled tubular ~1~1 .llbf~ which are eYp~n~led radially ou~waf~l:lly into contact with a body passageway, the ,..F ..bf ~ being pl~ti~ ~lly dero,l.led beyond their 20 elastic limit and the memhMs being ~",-~n~ ly fixed within the body.
Suitable m~tPri~l~ for the fabri~ti-n of these tubular-shaped ll~cmbe~ would in~lllde silver, t~nt~ m, st~inless steel, gold, ~ il,..., or other suitable pl~ti~lly derol,llable mat.ori~l~ which may be p~ nel~tly dero,nlad.
Pe~ n~nl defO~I"~liOn iS achieved when the m~tt~ri~l is subjected to a force 25 which creates a strain greater than the elastic limit of the m~t.o.ri~l which is utilized to make the tubular member. The open-mesh configuration of such devices is soon enca~ tPA by body tissue and cannot be removed. The e~r~ing of the elastic limit of the m~terj~l used in such devices is also b~liL.ed to co.llpro.l.ise the ~"-.ance of the devices in situ.
~ rleld of the Invention The invention relates to tissue sup~ g devices (stents), preferably vascular stents for lcp~;--ng blood vessels, and more particularly, to non-S l~.no~ble devices which will ~ ~ nf ntly su~.l a dilated stenn~ic of atubular organ (hollow viscus) such as a blood vesse~.
- -k~, ~u--d of the I..~.h.on In the past, permanent or biodegrad~hle devices have been developed for i...pl~ht~l;nn within a body passageway to ~..Aint~;n vascular patency. These 10 devices are typically d~ lr. ;7~d by the ability of such an intravascular device to be enlarged radially after having been introduced ~,~;u~; n~!-cly, to be t.,.n~. ~d t~n~ll...,in~lly, and to be po~itinned in a desired loc~inn. These devices are eitha r ~l~Anded ~npcl~ni~?~lly~ such as by the e .lMn~:nn of a .,~dl~l positinnf~d inside the device, or are capable of lc~ ;n~ stored energy 15 to expand Ihr--.selves upon actu~tion within the body.
U.S. Patent Nos. 4,739,762, 4,776,337 and 4,733,665 ~ ose P-l-Andahle and deformable intr~ min~l vascular grafts in the form of thin-walled tubular ~1~1 .llbf~ which are eYp~n~led radially ou~waf~l:lly into contact with a body passageway, the ,..F ..bf ~ being pl~ti~ ~lly dero,l.led beyond their 20 elastic limit and the memhMs being ~",-~n~ ly fixed within the body.
Suitable m~tPri~l~ for the fabri~ti-n of these tubular-shaped ll~cmbe~ would in~lllde silver, t~nt~ m, st~inless steel, gold, ~ il,..., or other suitable pl~ti~lly derol,llable mat.ori~l~ which may be p~ nel~tly dero,nlad.
Pe~ n~nl defO~I"~liOn iS achieved when the m~tt~ri~l is subjected to a force 25 which creates a strain greater than the elastic limit of the m~t.o.ri~l which is utilized to make the tubular member. The open-mesh configuration of such devices is soon enca~ tPA by body tissue and cannot be removed. The e~r~ing of the elastic limit of the m~terj~l used in such devices is also b~liL.ed to co.llpro.l.ise the ~"-.ance of the devices in situ.
-2- ~ 2 1 99 9 5 6 U.S. Patent No. 4,969,458 discloses a vascular stent formed from a wire co-..pol-~nt made of m~t~.ri~l, such as copper alloy, !;~n;l~..., or gold, wherein the wound configuration unwinds upon er~nn and beom~ a ~manellt prosth~ocic stent, similar to prior art devices ~ ose~ above, and is not removable.
U.S. Patent No. 4,969,890 discloses various configurations of shape-memory alloy members which have been previously radially collll,lessed and which, upon positi~ning within the body and th.o~n~l activation, expand by thems~lves to become a p~ lanenl prosthecis within the body. In this regard, the reference teaches a device which Opcndles in a similar fashion to the deviceAi~losod in U.S. Patent No. 4,485,816. U.S. Patent No. 4,485,816 ~li~loses a shape-memory alloy staple which, when heated, penel-dtes and cinches tissue logelhcl. Shape-memory alloy hictori~lly has been used to pclr~,ll.l work in such a fashion wherein the col--ponen~ llains in a strong ~.-c~enit;c state after te.ll~.dlulc: activation. That is, above its tr~nciti~ .e from n~nsile to ~stenite, and as the refe.ences above ~i~close, the shape-memor alloy either dilates an incGIl~pelent blood vessel or holds se~mentc of tissue loge~ r. Neither of these devices is practically removable by a method which does not require ~ulge ~.
Shape-memory alloys possess the useful charactçrictir- of being capable of ch~nging physical dimencionc upon heating above a first tr~ncition ~r~ e, Af, between a soft ~--arlcllsitic met~ lrgical state and a hard ~IJstel-;l;c m~Pllllrgical state of the alloys. A shape-memory alloy .~.e-..ber can be p~ ced while in a high te..-pe.dlule ~llctpnitic phase to take on a first 25 configuration. After cooling the shape-memory alloy member below a second t~nSiti~n telll~ldlule Mf between the ~l~ctenitic and martensitic states withoutchange of physical .1imencion~, the shape-memory alloy member can be ...e~hAnir~lly deformed into a second configu~tion. The shape-memory alloy member will remain in this second configuration until further heating to a 30 ~ e above Af at which time the shape-memory alloy m~mb~r will revert to its first configuration. A shape-memory alloy member can exert large ~3- 0 2 1 99 9 5 6 forces on ~ nt memhers during the transition from the second configuration to the first configul~ion. Numerous inventions have taken advantage of shape-MOl~ alloy members capable of exerting this thermally activated force.
Shape-l,.c"lol~ alloys have the further useful ch~r~~-t~rictic that, in the 5 "~t~nsilic phase, the stress-strain curve eyhihitc a plateau indic~ting that alimited increase in strain can be achieved with i",pGf~eplible increase in stress.
This "~t~.lsitic stress-strain plateau usually defines the range of .,.~,h~nir~lstrain which can be recovered by the applir~tion of heat. Fyce~l;ng the upper end of this strain range may result in non-heat recoverable deÇc,~ ;on.
U.S. Patent No. 5,197,978, hereby inc~ ted by lGr~nce, ~licrloses shape-",e"wl~ alloy tissue s..ppolling devices that are made to expand or shrinkradially upon ~~-ech~ni~l or thermal ~~tn~tion~ and, in particular, devices thatare removable from the body.
It would be advantageous to have a tissue s.-l.pol~ing device of a 15 genPr~lly tubular configuration which can be inselled into a body duct or cavity while in an ~u .~ ,pAnded shape and then be eYr~nded to provide pe- ,..~nent Su~ for the tissue forming the duct or cavity, such that the device when eYr~nded does not exert a radial load on the su~ ed duct or cavity and where the device when eYr~n~ed has sl~fficient crush recic~nce to provide s.~ for 20 the duct or cavity when the duct or cavity exerts a normal radial co",p~ssi~e load on the device as the result of major con~,aclions of the tissue.
It would be further advantageous to have a tissue ~.lppOlliflg device, for cimlllt~n~,Jc ~"ppoll of cavities of different sizes, in which larger e,~p~nd~
device sizes do not require higher exr~nci~ n l,r~ss.l~s than smaller device 25 sizes, so that the potenti~l for dicc-ection and/or tissue ~l~m~e is minimi7~d, and where further the device remains somewhat flexible to accommod~te mov~..,elll of soft tissue.
It would be further advantageous to have a heat-to-expand tissue s.~ ing device that does not need to be cooled prior to inct~ tion and 30 which provides pel",anent tissue support while in the ",~nsite state during service.
- -W O 96/09020 PCTrUS95/12092 It would be further advantageous to have a method for reversibly manipulating the configuration of a device decignpd for tissue support, in orderto fi~ itAte. m-~hinin~, debulling, etc. of hard-to-reach interior surfaces of the device wilhoul affecting the funrtiQnAlity of the device in a final product.
S~ ldr~ of the In~ention The invention provides a tissue s.~ ing device compricing a stent-like ~e~.-h of a shape-memory alloy which transforms from a martensitic mPt~ rgical state to an "llctenitir metallurgical state when heated above a first - tr~n~iti~nn te~ dtur~ Af and transforms from the g~t n;l;c state to the 10 ~ll~t~nsilic state when cooled below a second trAncition ~~ dture Mf. The stent-like mPmber is me~h ~ni~lly defGllllable without plastic defolllldtion in a body FACc~e of a living person from a first configuration while in the ll~nsitic state to a second configuration in the .ll~nsilic state and the Af and Mf ~nSitirJn telll~ldtul~s are snffici~Pntly above a body telllpelalul~ of the 15 living person to prevent recovery of the stent-like .~ ber to the first configuration by heating the stent-like mr~llb~ above Af without ~...-~nFrlly ~I~-"~h~g s.lllo..n~ling tissue of the living person, the stent-like mPmbPr exhibiting a strain on a hori70ntAl plat~au of a stress-strain curve of the shape-llle~llG~ alloy when permAnently po~itionP~l in the tubular organ.
The stent-like member can have various fea~ules. For inct, nr,e, the stent-like mPmber can have a tubular shape with a plurality of slots, each of the slots e~ten~ing parallel to a central ~cis of the stent-like mPml-er. The slots can be rectangular in shape and ends of the slots cil~;umr~.erltially ~djacP-nt to each other can be offset in an axial direction. The slots can form a l~nifollll pattern with at least two axially spaced-apart slots aligned with each other at locations spaced circumferentially around the stent-like ...r...~e~. In the eYr~n~ed cQndition, the stent like member can have an essPnti~lly cndrr~~ mesh-like shape which inhibitc thrombosis when eYr~nded in an artery of a living person.
The stent-like mPmbsr can include struts and the stent-like member can be 30 ra~ially eYr~n~ecl to an exr~ndPcl configuration wherein the stent-like member wo 96/09020 PCT/us95/12092 ,_ has a planar cylintlrirql profile and the struts are not twisted such that edgesthereof project radially outwardly. Radi_l eyrqncion of the cylin~rir-q-l stent-like device provides wlifo~ contact with the artery wall and a unifol~ cylinrlrirql lumen which allows l~....n~r blood flow or at least minimql turbulent flow.
5 Turhulent flow is known to promote platelet agg,cga~ion and the onset of .h~c;s. Similqrly~ ini~ ;on of stent twisting helps to m~inPin lqminqr flow as well as elimin~te cignifi~q~nt arterial wall ~q.na~,c attributable to the sharp edges of a twisted stent. Such arterial ~qma~e can lead to sub-acute ll~r~...bosic and/or extensive neointem~l proliferation. The shape-memory alloy 10 is preferably an alloy of Ni and Ti having an Af 2 62~C. The stent-like ..be~ can inrl~des at least one hinge-like mPmher eYtPn~ing between ~Aj~cPnt se~tion~ of the stent-like mprnber. The hinge-like member can be formed int~ral with the se~tion~ of the stent-like mPmber and the hinge-like ..b~l can have an axial length shorter than an axia~ length of each section of 15 the stent-like .ne~l~ber. The hinge-like member can comrrioes a single axially eYtçn~lin~ strip of the shape-memory alloy.
The invention also provides a method of imp1~nting a tissue su~po,Ling device comr~ ng a stent-like mPmber of a shape-l.~G~I-ol~ alloy having ",arte.~silic and ~ ;c m~t~lhlrgical states and a ~nsitinn te ~-pf ~lv.~ Af 20 th~l~bGl~GGn. The method includes mPrh~nirally eyr~n~ing the stent-like ..b~r in its martensitic state followed by heating the eyr~n~e~ stent-like ~--~---be~ above Af and further eYr~n~ing the stent-like mPmber after which the stent-like mçmber is cooled to body te~ dlule. The Af ~Illl~lA~lllc can be above 37~C and below 62~C, for inct~nce 40 to 50~C and the alloy can be a 25 NiTi alloy. The method can further include c-imring the tissue ;~u~ling device onto a balloon located at a distal end of a c~thPtçr and navigating the tissue su~olLing device to an application site within the tubular organ. The n-l;ng step can be carried out by ,ll~rh~nic~lly e~r~nding the tissue sup~ ing device until the balloon is fully infl~tP~
W O 96/09020 PC~r~US95/12092 Brief Dese, ;lJ~ion of the Drawin~
FIG. 1 shows a side view of a tissue ~.-p~ g device in accor~ce with the invention;
FIG. 2 shows a cross-sectinn~l view of a tissue a~ ing device in 5 acco~ance with the invention; and FIG. 3 shows a tissue ~up~lling device in accord~ce with the invention comrricing two tissue s.l~.ling c~ joined by a bridging system.
Detailed Des.. ;~tion of the Invention According to the invention, a tissue s~ ing device is provided which can be inserted into a body passage, such as a blood vessel, duct or caviey~ andused to ~uppo l the tissue forming the duct or cavity. In particular, a tissue s.,l,po.ling device compricing a m~t~ri~l which exhibits a stress-strain curve wht~,;n an increase in strain can be achieved with a negligible increase in 15 stress. The tissue suppolling device is of generally tubular shape is provided which can be inserted into a body duct or cavity in an ~lneyr~nded shape and tnen be eYr~nd~ at a desired pocition in the duct or cavity to form a pc ~--anent s.ll,~.ling SLI~ICIU1G for the tissue surrounding the eyr~nded device.
The tissue ~u~polling device can be fabricated from a shape memory 20 alloy such as a binary Ni-Ti alloy or NiTi alloy having one or more ~l~litiQn~
el~...ent~ added thereto. Other possibilities include shape memory alloys from the Cu-Al-Ni system. Such alloys have martensitic and ~)sle~ mPt~ rgical states and a tr~nCitir~n lenlpc~d~ thel~bel~n. The shape-memory alloy accor~ing to the invention is char~cteri7ed by a stress/strain curve in the 25 martensite state wl-~;n a limited increase in strain can be achieved with il"~ Lible increase in stress.
A tissue ~u~lling device according to the invention can be made from a Ni-Ti alloy whose tensile strength in the ..,a,lensilic state at human body te.ll~,dlule is 8 to 25 ksi. According to one embodiment of the invention, the 30 trancition ~ dl~re at which the alloy transforms from the martensitic to the _7_ ~ ~ ~ 9 ~ ~ 5 6 n;l;r state is preferably at a telllpcldture of 70~C or higher. At such t~--..pr-~ s, ~nown thermal recovery techniques for shrinking shape memory alloy tubular devices can not be used to recover the tissue ~.~ppo,ling device wil~oul C~J~;~ pe.,-lanel-t ~m~e to su.lounding tissue or blood due to 5 thermal trauma which has been found to occur when tissue/blood is eYpose~ to te~ u~.es above 62~C.
A first embo~limPnt of a tissue s~lppolLing device 1 in accor~ ce with the invention is shown in FIGS. 1 and 2. As shown in the side view of FIG. 1, the device 1 in~ludes a plurality of rectiline~r slots 2, 3. Slots 2 are arranged 10 in axially aligned pairs such that a first slot 2a intel~ts one axial end 4 of the device 1 and the other slot 2b intel~cls the other axial end 5 of the device 1.
Slots 3 are ~l~nged such that cil-;u..--er nlially ~dj~c~nt slots 3 are ~
by a pair of the aligned slots 2. Further, a single slot 3 is located between aYial ends 4, 5. As shown in FIG. 2, slots 2, 3 are distributed in a uniro 15 pattern around the devices. When the device 1 is ~p~nde~ by infl~ting a balloon of a balloon c~theter~ legs 6 eYten~ing bel~veen axial ends of slots 2, 3 are ~ ni~ally deformed such that they are no longer parallel to the center axis of device 1.
FIG. 3 shows a device 1 compricing first and second secti~nc la, lb 20 joined by bridging member 7. The bridging mPmher can have any suitable configuration such as a straight, helical (shown in pha~ltolll in FIG. 3) curvedor wavy strip. If desired, any number of sections of device 1 could be int~ n~ted by bridging members 7. Also, adjacent sections of device 1 can be CO~ CCI~ by a plurality of bridging ~~-f~--be~.S which are spaced apart and 25 di~LIib.l~d at dirrt;l~t locations around the ci-cu,llÇen_.~ce of the stent. The "l shown in FIG. 3 is ad~,an~g~ous for nego~iat ng tortuous body cavities such as blood vessels having sharply angled bends therein and for n~1;ng se~tiQn~ la, lb to different di~m~ters The stent-like member l according to the cl~im~ invention, when 30 fabricated from a Ni-Ti shape-memory alloy, can be eYp~nded in a blood vesselto a range of desired sizes by infl~ting a balloon cath~te~ to a pl~s~lle of 4-lO, WO 9~ 020 PCT/US95/12092 preferably 6-8 ~n--o5~h~res of ples~ure in the balloon c~thPtPr. When the stent is e~p~nt3~Pd, the slots are enlarged into generally tli~mQn~ shaped rectangularopenings ~l~ gPA in a uniform pattern that is in the form of a mesh-like lattice.
In the f-..bod;. .P-nt shown in FIG. 3, eYp~n~i~m of the individual stent-like S ~ b~ la, lb can be~lrol,lled s~ ~ly to achieve dirre.~nt~ m~pters.
Due to the eYr~nci~n in the martensitic con~3itiQn, stent-like mPmbers eYr~nt3~Pd to larger sizes do not require higher eyr~nci~n ~ s~uf~s than stent-like ",~ ---he-~ eYp~nt3~p~ to smaller sizes provided that the tissue ~ul)polling device co.~ ;~s stent-like .~.~ ..hets made from the sarne generally tubular shape-10 Illelllol~ alloy m~tPri~l. This embodiment offers the advantage of minimi7ingthe potPnti~l for r3icsPction and/or tissue damage and consequently minimi7Ps the need for ~ditit~n~l st~Pnting and the possibility of acute or sub-acute thrombosis.
The stent-like member 1 can be position~p~ at its application site in a low 15 profile configuration with radial tlimpncio~s small enough to allow navigation of orifice and ducts leading to the site of appli~tion The stent-like memher 1 can be positinnpd by means of a balloon catheter device having a lumen portion, balloon portion, and guide portion with the stent-like mPmber 1 ~u~ nt~ing the balloon portion. In a prefc~,ed embot3iment, stent-like mPmber 1 is 20 ,.~h~nit~lly crimpe~i securely to the balloon portion prior to insertion of the balloon c~thPtw device in a blood vessel. Other mPthotlc for ~csllring stent s~culily on the balloon are within the scope of this invention.
In use, the balloon portion is eYp~nd~P~, thus deÇol,~ g stent-like ,..P ..bt:l 1 radially outward against an inner wall of a blood vessel, and forming 25 a s~polLing structure for the blood vessel. The eyp~ncion of the stent-like .b~ according to the invention takes place in the elastic region of the stress-strain curve defined by the horizontal plateau in that curve. The deformed stent-like membPr 1 can comprise the tubular shape shown in FIGS.
1-3 or any other suitable shape which can be .~e~h~ni~lly deformed without 30 p~ nPn~ly derol-"ing the device. The stent is d~Pcign~P~ so that the strain in the eYp~nded stent-like member l is controlled such as by slot length of the slots 2, 3. Longer slots allow for longer beam elemf~ntc which can be ~leflf~t through any fixed fiictAnce at their extremities more easily than short beams.
Increase in fii~pl -~Pmf nt can be achieved with lower stresses than in the casewhere the beam elP ...~nl~ are longer. SimilArly, the cross-section of the beam - S Cl- .--f~n~C can be varied to provide more or less beam flexibility either by controlling the total areas or the geo,l,eLIy of the cross-s~tinm Use of a shapel"e...o,~ NiTi alloy for the device is advAntageous since such mqtrriAl can exhibit anti-tl"o.l.bolic pçù~ lies.
Once the balloon cAthetf r has been removed by cnllArcing the balloon 10 portion, stent-like mf mbe r 1 is left impl~qnte~ to pell..Anfelltly suppoll the blood vessel. The overall geometry of the stent-like member 1 ensures that the SV~a~I!A~'1r at e rAncinn is minimi7~d and is propcllional to the eYpAnf1e~ si_e of the stent-like l~r~b~ Since the implAntr~ stent-like mf mbf r exhibits a strain on a ho.;,nl-tAl plateau on a stress-strain curve for the shape---,e",oly15 alloy, the stent-like l"e",ber can support the blood vessel at e~c~nl;Ally constant stress. The eYrAn~ed ~iimp-ncions of the stent-like member 1 cannot be adjusted by the amount of force used to expand the device. Instead, the exrAndecl fl;A-I~cter is controlled by the ~imencions of the duct, cavity or, blood vessel, into which the stent-like membfer 1 is eYpAn~le~. According to the invention, 20 the shape Illenluly alloy of the stent-like ....~n~bcl 1 l~l"ains in the martensitic state when the stent-like member 1 is in service in a human body.
The duct ~ )o~ e pr~ ies of an implanted Illelllbf r can be controlled by the wall thirl~nf~ss of shape-memory alloy forming the tube-like ~lf .11~ , the length of lon~ituliinAl slots 2, 3 and by the degree of eYrAnCion of 25 the stent-like mf mber 1. An implqnt~P~ stent-like mPmber 1 has suffiripnt crush recictqnce to provide support for a duct or cavity or blood vessel when such duct or cavity or blood vessel exerts a nonnal radial co",~ si-Je load on the ~ stent-like member 1 as the result of a major contraction of the duct or cavity or blood vessel. Preferably the stent-like member 1 can be s--ffi~iPntly robust to 30 S~ )ll a coi~un~y artery when major contractions are inf1irqtP~. The ;...1.1A.~P~ stent-like member 1 eccentiqlly does not exert a radial load on the duct or cavity or blood vessel it is sup~o-ling. The imp1~nt~d stent-like --b~l 1 allows for a small amount of radial recoverable dPflçction at low loads as the suppol~d duct or cavity or blood vessel cont~rt~ The low force needed to cause el~tir~lly recoverable defl~Pction of stent-like mPmbPrs 1 in 5 re~l oncf to tissue duct contraction can advantageously minimi7e irrit~tion to the duct wall when small contr~rti~nc occur.
Although the invention has been described as useful in an angioplasty lOCedUlC, it is understood that the invention is not limited to such a procedureor the use of a stent-like member in a blood vessel. It should be appar~nt to 10 one sl~lled in the art that the invention is useful in sup~lling body tissue in general as well as various blood vessels, e.g., in s,~l~h~n~!us vein grafts, thevena cavae, the aorta, the renal artery, the iliac artery, the femoral artery, the l artery, the carotid artery, the cranial arteries, p~llmnn~ry arteries, etc.
The various çmhodimpnt~ of the invention are also useful with other tubular 15 organs inrlvtling but not limited to the pros~e, biliary tract, the esoph~us, the t~~h~, the fallopian tubes, the vas deferens, the ureters, the tear ducts, the salivary ducts, etc.
According to another embo~imPnt of the invention, a stent-like mPmber is given a memory shape which is larger in size than the lumen of the body 20 organ in which the stent is to be loc~t-P~. According to this embo~limPnt, the stent-like ~IlP~lb~P'l iS con~litione~ by techniques known to those skilled in the art to ...c~ . ;7~ a large ~ m~PtPr and the shape memory alloy from which the stent is made has tran~ol,-,alion ~e~ )clatulf s Mf and Af above body t~ C.
In use, the stent-like rnPmber is co."pr~sscd in the martensitic con~lition to have 25 a smaller ~i~metpr when the stent is put on a c~theter. Then the stent-like mpmber is introduced through a body organ by means of the c~thptrr and once P~ r positiQJled~ the stent is ll.t-~h,qlnir~lly e~cr~n~p~ by balloon e~r~n~ion without plastic de~l",ation of the stent, after which the stent is heated, in vivo, above body t~ ldlu~e to a tr~ncition lelllpeldlurt; Af to expand the stent into 30 the ~llsteni~ co~rlition and thus expand the stent-like mPmbçr to the memori larger ~l;z...f t. ~ shape. Subsequently, the stent-like mPmber is allowed to cool -to body ~ll~pe~dlure and return to the martensitic con~itioll. In a plef~ d emho~imPnt~ Af is above 37~C and below 62~C such as 40 to 50~C and Mf > 37~C.
The stent accG~ing to the second embodim~pnt can be used in various S ways. For ~ nc~c, this heat eYp~ndahle stent can be irnpl~nted by partialballoon c~ n~:on of the stent followed by co ,-lct~ on created by i~ti-)n of heat. The partial balloon eyr~nci~n would be sl~ffici~Pnt to locate the stent at the target site with final eYr~n~;~ n aimed at produçing a larger final ~i5.~. ~r to S~lppull the artery. The heat activated final PYr~ncion would exerta radial force on the artery wall inshnl;1nP~ously as the stent takes on its t.,n;t;c phase when heated to an elevated le.~ .alu~e. This radial force e~nbeds the stent in the artery wall in a controlled way as a result of interacti~
b~ ~n the natural recilienre of the arterial wall and predc~.illined final e-p~ ld~d ~ n~e~C~ of the stent. After the stent is heat eY~r~nde~d, the blood stream rapidly cools the stent into its martensitic phase. As a result, the enh~nr~d ductility of the martensitic phase allows the stent to accommo~te v~-iqtions in the ~ r of the artery and provides a fixed stent di~mPter which does not exert a radial force on the artery, but rather simply acts as a Sllp~ ll U~ ~Ul~.
The heat eYr~ded stent accolding to the second embodimPnt of the invention reduces the b~otldullla ~cc~:~P~I with normal balloon impl~nt~tinn of stents by convention~l balloon angioplasty. That is, it is well known that di~ n~ of arterial walls can be caused by eYr~n~ing balloons and internal ~duma can be ~ "pecl~d when any me~.hqni.~,ql force is applied to the arterial walls. In the case of balloon angioplasty, the total balloon area cont~~ts the inner arterial wall and the trauma is t;Al~.,si~re. Furth~.lllGre, balloons can protrude through stent structures and extend beyond the ends of stents to give asimilar effect. The heat eYr-qnded stent accor~ g to the second embotlimpnt can avoid the b~ problem since it is not n~,c~.y to fully expand the stent by balloon eYpqnciQl~. That is, by partial eY~r~n~iQn of the stent by using a bqllooll and final eYrqncion by application of heat there is less contact of the - 12 - ~ 2 1 9 9 9 5 6 inner arterial wall with foreign bodies such as the stent and balloon than in the case where a stent is fully eYp~n~ed by balloon r-p~ OIU Thus, the heat eYr~nded stent according to the second embodiment can be implanted in a ",aml~r which leaves the major area of the stented wall unarfecled whereby S lower levels of cell proliferation :lCC~ciat~d with recover,v from the trauma and hence less r~tc--o~;C will occur.
The tissue su~ ing device according to the r1~;...~ invention is non-.- a~n~l;c and corrosion resict~t- Further, the tissue ~u~ iJIg device can include means for making the stent visible and radiopaque under convention~l 10 nuol~)scopes when in the human body. For inst~nce, the radial wall thi~nesc of ~e tissue s.-p~lling device can be from 0.005 inches to 0.020 inches, thus making the stent visible by radiopaque techniques.
In yet another embo iiment of the invention, the stent-like member 1 with shape memor,v plol~e~lies can be reversibly manipulated during its 5 .~ r~~ e to f~ilit~t~ secon~ry ~l~esses without affecting the functionality of the final stent-like member 1 yr~duc~. For ey~mr~ the origin~ meter of the stent-like member 1 may be incl~sed to enable the intern~l surf~es to be nic~lly altered by ~locesses such as m~rhining, deb,llling, etc., and later, the ~ ~l~ ~ of the stent-like memher 1 can be r~lull,cd to its original 20 ~ fnc~ s by heating the stent-like ~lle,llber 1 above the tr~ncition ~Ill~e~ re of the shape Ill~llloly alloy. By this m~thod~ stent-like m~ombers with interiors... r~ ~c of exceptional ma~hined finish can be obt;~incd in a final stent-likepl~luct. ~sscs which may be used to create surface finiches of high quality include but are not restricted to m-~h~nical ~loCeSseS such as lapping and 25 g. ;r~ buffing and honing and various çhemir~l and electro-chpmir~l etching and poliching techniques. In ~ ition, the stent can be surface treated and/or coated with any sui~ble m~ l such as polymeric m~tPn~l found to be bPn~fici~l in providing a surface finish which minimi7es thrombogenicity or ~~st~--os;c or other adverse long or short term effects of stent deployment in 30 colvn~ arteries or other duct-like loc~tionc in the human body. The coating could be a drug or drug-like m~t~ l or could be a coating which accepts drugs of all types which when released in a site ~peçific manner are b~n~Pfici~l to contiguous tissue. Of particular interest would be drugs which are be-nPfiç
when applied in a site spe~-ific l.latmer but have adverse side effects when applied syste-mi~lly. If desired, the coating could also incol~olate additives for 5 drug delivery or other mP~iic~l pul~ses.
The stent accolding to the invention can provide benPfit~ in preventing l}llo,llbog~,c h",onc~ In particular, the stent geolllell~ can be controlled to provide a planar cylindric~l profile when eYr~nded with minim~l strut twisting and oulw~dly protruding stent strut te, .in~l;on~. That is, whereas the struts 10 forming the mesh-like structure of st~inless steel stents have a t~ndency to twist such that the edges thereof project radially oulw~ly when eyr~nd~pd by balloon infl~ti~m, the stent accor~ing to the invention can be eY~r~nd~Pd without such twisting of the struts. Further, colllp~c;d to a st~inlp~ steel stent having the same configuration, the stent according to the invention can be eYr~nd~Pd atlS much lower balloon Pyr~n~ion prcssu~s. The lower eYr~ncion pl~S~ul~S used in acco~ance with the invention ....ni...;~e barut,dullla and the smooth outer cylin~lniç~l surface of the exp~nded stent in accordance with the invention provides non-lh~lllbogcnic plupellies.
The forcgoing has described the principles, ~ere"ed embodiments and 20 modes of operation of the present invention. However, the invention should not be consl,ued as being limited to the particular embo~iimpnt~ di~c~ P~. Thus, the above-desçrihed embo liment~ should be regarded as illustrative rather than restrictive, and it should be app,~ciated that variations may be made in those embodimPnt~ by workers skilled in the art without departing from the scope of 25 the present invention as defined by the following claims.
U.S. Patent No. 4,969,890 discloses various configurations of shape-memory alloy members which have been previously radially collll,lessed and which, upon positi~ning within the body and th.o~n~l activation, expand by thems~lves to become a p~ lanenl prosthecis within the body. In this regard, the reference teaches a device which Opcndles in a similar fashion to the deviceAi~losod in U.S. Patent No. 4,485,816. U.S. Patent No. 4,485,816 ~li~loses a shape-memory alloy staple which, when heated, penel-dtes and cinches tissue logelhcl. Shape-memory alloy hictori~lly has been used to pclr~,ll.l work in such a fashion wherein the col--ponen~ llains in a strong ~.-c~enit;c state after te.ll~.dlulc: activation. That is, above its tr~nciti~ .e from n~nsile to ~stenite, and as the refe.ences above ~i~close, the shape-memor alloy either dilates an incGIl~pelent blood vessel or holds se~mentc of tissue loge~ r. Neither of these devices is practically removable by a method which does not require ~ulge ~.
Shape-memory alloys possess the useful charactçrictir- of being capable of ch~nging physical dimencionc upon heating above a first tr~ncition ~r~ e, Af, between a soft ~--arlcllsitic met~ lrgical state and a hard ~IJstel-;l;c m~Pllllrgical state of the alloys. A shape-memory alloy .~.e-..ber can be p~ ced while in a high te..-pe.dlule ~llctpnitic phase to take on a first 25 configuration. After cooling the shape-memory alloy member below a second t~nSiti~n telll~ldlule Mf between the ~l~ctenitic and martensitic states withoutchange of physical .1imencion~, the shape-memory alloy member can be ...e~hAnir~lly deformed into a second configu~tion. The shape-memory alloy member will remain in this second configuration until further heating to a 30 ~ e above Af at which time the shape-memory alloy m~mb~r will revert to its first configuration. A shape-memory alloy member can exert large ~3- 0 2 1 99 9 5 6 forces on ~ nt memhers during the transition from the second configuration to the first configul~ion. Numerous inventions have taken advantage of shape-MOl~ alloy members capable of exerting this thermally activated force.
Shape-l,.c"lol~ alloys have the further useful ch~r~~-t~rictic that, in the 5 "~t~nsilic phase, the stress-strain curve eyhihitc a plateau indic~ting that alimited increase in strain can be achieved with i",pGf~eplible increase in stress.
This "~t~.lsitic stress-strain plateau usually defines the range of .,.~,h~nir~lstrain which can be recovered by the applir~tion of heat. Fyce~l;ng the upper end of this strain range may result in non-heat recoverable deÇc,~ ;on.
U.S. Patent No. 5,197,978, hereby inc~ ted by lGr~nce, ~licrloses shape-",e"wl~ alloy tissue s..ppolling devices that are made to expand or shrinkradially upon ~~-ech~ni~l or thermal ~~tn~tion~ and, in particular, devices thatare removable from the body.
It would be advantageous to have a tissue s.-l.pol~ing device of a 15 genPr~lly tubular configuration which can be inselled into a body duct or cavity while in an ~u .~ ,pAnded shape and then be eYr~nded to provide pe- ,..~nent Su~ for the tissue forming the duct or cavity, such that the device when eYr~nded does not exert a radial load on the su~ ed duct or cavity and where the device when eYr~n~ed has sl~fficient crush recic~nce to provide s.~ for 20 the duct or cavity when the duct or cavity exerts a normal radial co",p~ssi~e load on the device as the result of major con~,aclions of the tissue.
It would be further advantageous to have a tissue ~.lppOlliflg device, for cimlllt~n~,Jc ~"ppoll of cavities of different sizes, in which larger e,~p~nd~
device sizes do not require higher exr~nci~ n l,r~ss.l~s than smaller device 25 sizes, so that the potenti~l for dicc-ection and/or tissue ~l~m~e is minimi7~d, and where further the device remains somewhat flexible to accommod~te mov~..,elll of soft tissue.
It would be further advantageous to have a heat-to-expand tissue s.~ ing device that does not need to be cooled prior to inct~ tion and 30 which provides pel",anent tissue support while in the ",~nsite state during service.
- -W O 96/09020 PCTrUS95/12092 It would be further advantageous to have a method for reversibly manipulating the configuration of a device decignpd for tissue support, in orderto fi~ itAte. m-~hinin~, debulling, etc. of hard-to-reach interior surfaces of the device wilhoul affecting the funrtiQnAlity of the device in a final product.
S~ ldr~ of the In~ention The invention provides a tissue s.~ ing device compricing a stent-like ~e~.-h of a shape-memory alloy which transforms from a martensitic mPt~ rgical state to an "llctenitir metallurgical state when heated above a first - tr~n~iti~nn te~ dtur~ Af and transforms from the g~t n;l;c state to the 10 ~ll~t~nsilic state when cooled below a second trAncition ~~ dture Mf. The stent-like mPmber is me~h ~ni~lly defGllllable without plastic defolllldtion in a body FACc~e of a living person from a first configuration while in the ll~nsitic state to a second configuration in the .ll~nsilic state and the Af and Mf ~nSitirJn telll~ldtul~s are snffici~Pntly above a body telllpelalul~ of the 15 living person to prevent recovery of the stent-like .~ ber to the first configuration by heating the stent-like mr~llb~ above Af without ~...-~nFrlly ~I~-"~h~g s.lllo..n~ling tissue of the living person, the stent-like mPmbPr exhibiting a strain on a hori70ntAl plat~au of a stress-strain curve of the shape-llle~llG~ alloy when permAnently po~itionP~l in the tubular organ.
The stent-like member can have various fea~ules. For inct, nr,e, the stent-like mPmber can have a tubular shape with a plurality of slots, each of the slots e~ten~ing parallel to a central ~cis of the stent-like mPml-er. The slots can be rectangular in shape and ends of the slots cil~;umr~.erltially ~djacP-nt to each other can be offset in an axial direction. The slots can form a l~nifollll pattern with at least two axially spaced-apart slots aligned with each other at locations spaced circumferentially around the stent-like ...r...~e~. In the eYr~n~ed cQndition, the stent like member can have an essPnti~lly cndrr~~ mesh-like shape which inhibitc thrombosis when eYr~nded in an artery of a living person.
The stent-like mPmbsr can include struts and the stent-like member can be 30 ra~ially eYr~n~ecl to an exr~ndPcl configuration wherein the stent-like member wo 96/09020 PCT/us95/12092 ,_ has a planar cylintlrirql profile and the struts are not twisted such that edgesthereof project radially outwardly. Radi_l eyrqncion of the cylin~rir-q-l stent-like device provides wlifo~ contact with the artery wall and a unifol~ cylinrlrirql lumen which allows l~....n~r blood flow or at least minimql turbulent flow.
5 Turhulent flow is known to promote platelet agg,cga~ion and the onset of .h~c;s. Similqrly~ ini~ ;on of stent twisting helps to m~inPin lqminqr flow as well as elimin~te cignifi~q~nt arterial wall ~q.na~,c attributable to the sharp edges of a twisted stent. Such arterial ~qma~e can lead to sub-acute ll~r~...bosic and/or extensive neointem~l proliferation. The shape-memory alloy 10 is preferably an alloy of Ni and Ti having an Af 2 62~C. The stent-like ..be~ can inrl~des at least one hinge-like mPmher eYtPn~ing between ~Aj~cPnt se~tion~ of the stent-like mprnber. The hinge-like member can be formed int~ral with the se~tion~ of the stent-like mPmber and the hinge-like ..b~l can have an axial length shorter than an axia~ length of each section of 15 the stent-like .ne~l~ber. The hinge-like member can comrrioes a single axially eYtçn~lin~ strip of the shape-memory alloy.
The invention also provides a method of imp1~nting a tissue su~po,Ling device comr~ ng a stent-like mPmber of a shape-l.~G~I-ol~ alloy having ",arte.~silic and ~ ;c m~t~lhlrgical states and a ~nsitinn te ~-pf ~lv.~ Af 20 th~l~bGl~GGn. The method includes mPrh~nirally eyr~n~ing the stent-like ..b~r in its martensitic state followed by heating the eyr~n~e~ stent-like ~--~---be~ above Af and further eYr~n~ing the stent-like mPmber after which the stent-like mçmber is cooled to body te~ dlule. The Af ~Illl~lA~lllc can be above 37~C and below 62~C, for inct~nce 40 to 50~C and the alloy can be a 25 NiTi alloy. The method can further include c-imring the tissue ;~u~ling device onto a balloon located at a distal end of a c~thPtçr and navigating the tissue su~olLing device to an application site within the tubular organ. The n-l;ng step can be carried out by ,ll~rh~nic~lly e~r~nding the tissue sup~ ing device until the balloon is fully infl~tP~
W O 96/09020 PC~r~US95/12092 Brief Dese, ;lJ~ion of the Drawin~
FIG. 1 shows a side view of a tissue ~.-p~ g device in accor~ce with the invention;
FIG. 2 shows a cross-sectinn~l view of a tissue a~ ing device in 5 acco~ance with the invention; and FIG. 3 shows a tissue ~up~lling device in accord~ce with the invention comrricing two tissue s.l~.ling c~ joined by a bridging system.
Detailed Des.. ;~tion of the Invention According to the invention, a tissue s~ ing device is provided which can be inserted into a body passage, such as a blood vessel, duct or caviey~ andused to ~uppo l the tissue forming the duct or cavity. In particular, a tissue s.,l,po.ling device compricing a m~t~ri~l which exhibits a stress-strain curve wht~,;n an increase in strain can be achieved with a negligible increase in 15 stress. The tissue suppolling device is of generally tubular shape is provided which can be inserted into a body duct or cavity in an ~lneyr~nded shape and tnen be eYr~nd~ at a desired pocition in the duct or cavity to form a pc ~--anent s.ll,~.ling SLI~ICIU1G for the tissue surrounding the eyr~nded device.
The tissue ~u~polling device can be fabricated from a shape memory 20 alloy such as a binary Ni-Ti alloy or NiTi alloy having one or more ~l~litiQn~
el~...ent~ added thereto. Other possibilities include shape memory alloys from the Cu-Al-Ni system. Such alloys have martensitic and ~)sle~ mPt~ rgical states and a tr~nCitir~n lenlpc~d~ thel~bel~n. The shape-memory alloy accor~ing to the invention is char~cteri7ed by a stress/strain curve in the 25 martensite state wl-~;n a limited increase in strain can be achieved with il"~ Lible increase in stress.
A tissue ~u~lling device according to the invention can be made from a Ni-Ti alloy whose tensile strength in the ..,a,lensilic state at human body te.ll~,dlule is 8 to 25 ksi. According to one embodiment of the invention, the 30 trancition ~ dl~re at which the alloy transforms from the martensitic to the _7_ ~ ~ ~ 9 ~ ~ 5 6 n;l;r state is preferably at a telllpcldture of 70~C or higher. At such t~--..pr-~ s, ~nown thermal recovery techniques for shrinking shape memory alloy tubular devices can not be used to recover the tissue ~.~ppo,ling device wil~oul C~J~;~ pe.,-lanel-t ~m~e to su.lounding tissue or blood due to 5 thermal trauma which has been found to occur when tissue/blood is eYpose~ to te~ u~.es above 62~C.
A first embo~limPnt of a tissue s~lppolLing device 1 in accor~ ce with the invention is shown in FIGS. 1 and 2. As shown in the side view of FIG. 1, the device 1 in~ludes a plurality of rectiline~r slots 2, 3. Slots 2 are arranged 10 in axially aligned pairs such that a first slot 2a intel~ts one axial end 4 of the device 1 and the other slot 2b intel~cls the other axial end 5 of the device 1.
Slots 3 are ~l~nged such that cil-;u..--er nlially ~dj~c~nt slots 3 are ~
by a pair of the aligned slots 2. Further, a single slot 3 is located between aYial ends 4, 5. As shown in FIG. 2, slots 2, 3 are distributed in a uniro 15 pattern around the devices. When the device 1 is ~p~nde~ by infl~ting a balloon of a balloon c~theter~ legs 6 eYten~ing bel~veen axial ends of slots 2, 3 are ~ ni~ally deformed such that they are no longer parallel to the center axis of device 1.
FIG. 3 shows a device 1 compricing first and second secti~nc la, lb 20 joined by bridging member 7. The bridging mPmher can have any suitable configuration such as a straight, helical (shown in pha~ltolll in FIG. 3) curvedor wavy strip. If desired, any number of sections of device 1 could be int~ n~ted by bridging members 7. Also, adjacent sections of device 1 can be CO~ CCI~ by a plurality of bridging ~~-f~--be~.S which are spaced apart and 25 di~LIib.l~d at dirrt;l~t locations around the ci-cu,llÇen_.~ce of the stent. The "l shown in FIG. 3 is ad~,an~g~ous for nego~iat ng tortuous body cavities such as blood vessels having sharply angled bends therein and for n~1;ng se~tiQn~ la, lb to different di~m~ters The stent-like member l according to the cl~im~ invention, when 30 fabricated from a Ni-Ti shape-memory alloy, can be eYp~nded in a blood vesselto a range of desired sizes by infl~ting a balloon cath~te~ to a pl~s~lle of 4-lO, WO 9~ 020 PCT/US95/12092 preferably 6-8 ~n--o5~h~res of ples~ure in the balloon c~thPtPr. When the stent is e~p~nt3~Pd, the slots are enlarged into generally tli~mQn~ shaped rectangularopenings ~l~ gPA in a uniform pattern that is in the form of a mesh-like lattice.
In the f-..bod;. .P-nt shown in FIG. 3, eYp~n~i~m of the individual stent-like S ~ b~ la, lb can be~lrol,lled s~ ~ly to achieve dirre.~nt~ m~pters.
Due to the eYr~nci~n in the martensitic con~3itiQn, stent-like mPmbers eYr~nt3~Pd to larger sizes do not require higher eyr~nci~n ~ s~uf~s than stent-like ",~ ---he-~ eYp~nt3~p~ to smaller sizes provided that the tissue ~ul)polling device co.~ ;~s stent-like .~.~ ..hets made from the sarne generally tubular shape-10 Illelllol~ alloy m~tPri~l. This embodiment offers the advantage of minimi7ingthe potPnti~l for r3icsPction and/or tissue damage and consequently minimi7Ps the need for ~ditit~n~l st~Pnting and the possibility of acute or sub-acute thrombosis.
The stent-like member 1 can be position~p~ at its application site in a low 15 profile configuration with radial tlimpncio~s small enough to allow navigation of orifice and ducts leading to the site of appli~tion The stent-like memher 1 can be positinnpd by means of a balloon catheter device having a lumen portion, balloon portion, and guide portion with the stent-like mPmber 1 ~u~ nt~ing the balloon portion. In a prefc~,ed embot3iment, stent-like mPmber 1 is 20 ,.~h~nit~lly crimpe~i securely to the balloon portion prior to insertion of the balloon c~thPtw device in a blood vessel. Other mPthotlc for ~csllring stent s~culily on the balloon are within the scope of this invention.
In use, the balloon portion is eYp~nd~P~, thus deÇol,~ g stent-like ,..P ..bt:l 1 radially outward against an inner wall of a blood vessel, and forming 25 a s~polLing structure for the blood vessel. The eyp~ncion of the stent-like .b~ according to the invention takes place in the elastic region of the stress-strain curve defined by the horizontal plateau in that curve. The deformed stent-like membPr 1 can comprise the tubular shape shown in FIGS.
1-3 or any other suitable shape which can be .~e~h~ni~lly deformed without 30 p~ nPn~ly derol-"ing the device. The stent is d~Pcign~P~ so that the strain in the eYp~nded stent-like member l is controlled such as by slot length of the slots 2, 3. Longer slots allow for longer beam elemf~ntc which can be ~leflf~t through any fixed fiictAnce at their extremities more easily than short beams.
Increase in fii~pl -~Pmf nt can be achieved with lower stresses than in the casewhere the beam elP ...~nl~ are longer. SimilArly, the cross-section of the beam - S Cl- .--f~n~C can be varied to provide more or less beam flexibility either by controlling the total areas or the geo,l,eLIy of the cross-s~tinm Use of a shapel"e...o,~ NiTi alloy for the device is advAntageous since such mqtrriAl can exhibit anti-tl"o.l.bolic pçù~ lies.
Once the balloon cAthetf r has been removed by cnllArcing the balloon 10 portion, stent-like mf mbe r 1 is left impl~qnte~ to pell..Anfelltly suppoll the blood vessel. The overall geometry of the stent-like member 1 ensures that the SV~a~I!A~'1r at e rAncinn is minimi7~d and is propcllional to the eYpAnf1e~ si_e of the stent-like l~r~b~ Since the implAntr~ stent-like mf mbf r exhibits a strain on a ho.;,nl-tAl plateau on a stress-strain curve for the shape---,e",oly15 alloy, the stent-like l"e",ber can support the blood vessel at e~c~nl;Ally constant stress. The eYrAn~ed ~iimp-ncions of the stent-like member 1 cannot be adjusted by the amount of force used to expand the device. Instead, the exrAndecl fl;A-I~cter is controlled by the ~imencions of the duct, cavity or, blood vessel, into which the stent-like membfer 1 is eYpAn~le~. According to the invention, 20 the shape Illenluly alloy of the stent-like ....~n~bcl 1 l~l"ains in the martensitic state when the stent-like member 1 is in service in a human body.
The duct ~ )o~ e pr~ ies of an implanted Illelllbf r can be controlled by the wall thirl~nf~ss of shape-memory alloy forming the tube-like ~lf .11~ , the length of lon~ituliinAl slots 2, 3 and by the degree of eYrAnCion of 25 the stent-like mf mber 1. An implqnt~P~ stent-like mPmber 1 has suffiripnt crush recictqnce to provide support for a duct or cavity or blood vessel when such duct or cavity or blood vessel exerts a nonnal radial co",~ si-Je load on the ~ stent-like member 1 as the result of a major contraction of the duct or cavity or blood vessel. Preferably the stent-like member 1 can be s--ffi~iPntly robust to 30 S~ )ll a coi~un~y artery when major contractions are inf1irqtP~. The ;...1.1A.~P~ stent-like member 1 eccentiqlly does not exert a radial load on the duct or cavity or blood vessel it is sup~o-ling. The imp1~nt~d stent-like --b~l 1 allows for a small amount of radial recoverable dPflçction at low loads as the suppol~d duct or cavity or blood vessel cont~rt~ The low force needed to cause el~tir~lly recoverable defl~Pction of stent-like mPmbPrs 1 in 5 re~l oncf to tissue duct contraction can advantageously minimi7e irrit~tion to the duct wall when small contr~rti~nc occur.
Although the invention has been described as useful in an angioplasty lOCedUlC, it is understood that the invention is not limited to such a procedureor the use of a stent-like member in a blood vessel. It should be appar~nt to 10 one sl~lled in the art that the invention is useful in sup~lling body tissue in general as well as various blood vessels, e.g., in s,~l~h~n~!us vein grafts, thevena cavae, the aorta, the renal artery, the iliac artery, the femoral artery, the l artery, the carotid artery, the cranial arteries, p~llmnn~ry arteries, etc.
The various çmhodimpnt~ of the invention are also useful with other tubular 15 organs inrlvtling but not limited to the pros~e, biliary tract, the esoph~us, the t~~h~, the fallopian tubes, the vas deferens, the ureters, the tear ducts, the salivary ducts, etc.
According to another embo~imPnt of the invention, a stent-like mPmber is given a memory shape which is larger in size than the lumen of the body 20 organ in which the stent is to be loc~t-P~. According to this embo~limPnt, the stent-like ~IlP~lb~P'l iS con~litione~ by techniques known to those skilled in the art to ...c~ . ;7~ a large ~ m~PtPr and the shape memory alloy from which the stent is made has tran~ol,-,alion ~e~ )clatulf s Mf and Af above body t~ C.
In use, the stent-like rnPmber is co."pr~sscd in the martensitic con~lition to have 25 a smaller ~i~metpr when the stent is put on a c~theter. Then the stent-like mpmber is introduced through a body organ by means of the c~thptrr and once P~ r positiQJled~ the stent is ll.t-~h,qlnir~lly e~cr~n~p~ by balloon e~r~n~ion without plastic de~l",ation of the stent, after which the stent is heated, in vivo, above body t~ ldlu~e to a tr~ncition lelllpeldlurt; Af to expand the stent into 30 the ~llsteni~ co~rlition and thus expand the stent-like mPmbçr to the memori larger ~l;z...f t. ~ shape. Subsequently, the stent-like mPmber is allowed to cool -to body ~ll~pe~dlure and return to the martensitic con~itioll. In a plef~ d emho~imPnt~ Af is above 37~C and below 62~C such as 40 to 50~C and Mf > 37~C.
The stent accG~ing to the second embodim~pnt can be used in various S ways. For ~ nc~c, this heat eYp~ndahle stent can be irnpl~nted by partialballoon c~ n~:on of the stent followed by co ,-lct~ on created by i~ti-)n of heat. The partial balloon eyr~nci~n would be sl~ffici~Pnt to locate the stent at the target site with final eYr~n~;~ n aimed at produçing a larger final ~i5.~. ~r to S~lppull the artery. The heat activated final PYr~ncion would exerta radial force on the artery wall inshnl;1nP~ously as the stent takes on its t.,n;t;c phase when heated to an elevated le.~ .alu~e. This radial force e~nbeds the stent in the artery wall in a controlled way as a result of interacti~
b~ ~n the natural recilienre of the arterial wall and predc~.illined final e-p~ ld~d ~ n~e~C~ of the stent. After the stent is heat eY~r~nde~d, the blood stream rapidly cools the stent into its martensitic phase. As a result, the enh~nr~d ductility of the martensitic phase allows the stent to accommo~te v~-iqtions in the ~ r of the artery and provides a fixed stent di~mPter which does not exert a radial force on the artery, but rather simply acts as a Sllp~ ll U~ ~Ul~.
The heat eYr~ded stent accolding to the second embodimPnt of the invention reduces the b~otldullla ~cc~:~P~I with normal balloon impl~nt~tinn of stents by convention~l balloon angioplasty. That is, it is well known that di~ n~ of arterial walls can be caused by eYr~n~ing balloons and internal ~duma can be ~ "pecl~d when any me~.hqni.~,ql force is applied to the arterial walls. In the case of balloon angioplasty, the total balloon area cont~~ts the inner arterial wall and the trauma is t;Al~.,si~re. Furth~.lllGre, balloons can protrude through stent structures and extend beyond the ends of stents to give asimilar effect. The heat eYr-qnded stent accor~ g to the second embotlimpnt can avoid the b~ problem since it is not n~,c~.y to fully expand the stent by balloon eYpqnciQl~. That is, by partial eY~r~n~iQn of the stent by using a bqllooll and final eYrqncion by application of heat there is less contact of the - 12 - ~ 2 1 9 9 9 5 6 inner arterial wall with foreign bodies such as the stent and balloon than in the case where a stent is fully eYp~n~ed by balloon r-p~ OIU Thus, the heat eYr~nded stent according to the second embodiment can be implanted in a ",aml~r which leaves the major area of the stented wall unarfecled whereby S lower levels of cell proliferation :lCC~ciat~d with recover,v from the trauma and hence less r~tc--o~;C will occur.
The tissue su~ ing device according to the r1~;...~ invention is non-.- a~n~l;c and corrosion resict~t- Further, the tissue ~u~ iJIg device can include means for making the stent visible and radiopaque under convention~l 10 nuol~)scopes when in the human body. For inst~nce, the radial wall thi~nesc of ~e tissue s.-p~lling device can be from 0.005 inches to 0.020 inches, thus making the stent visible by radiopaque techniques.
In yet another embo iiment of the invention, the stent-like member 1 with shape memor,v plol~e~lies can be reversibly manipulated during its 5 .~ r~~ e to f~ilit~t~ secon~ry ~l~esses without affecting the functionality of the final stent-like member 1 yr~duc~. For ey~mr~ the origin~ meter of the stent-like member 1 may be incl~sed to enable the intern~l surf~es to be nic~lly altered by ~locesses such as m~rhining, deb,llling, etc., and later, the ~ ~l~ ~ of the stent-like memher 1 can be r~lull,cd to its original 20 ~ fnc~ s by heating the stent-like ~lle,llber 1 above the tr~ncition ~Ill~e~ re of the shape Ill~llloly alloy. By this m~thod~ stent-like m~ombers with interiors... r~ ~c of exceptional ma~hined finish can be obt;~incd in a final stent-likepl~luct. ~sscs which may be used to create surface finiches of high quality include but are not restricted to m-~h~nical ~loCeSseS such as lapping and 25 g. ;r~ buffing and honing and various çhemir~l and electro-chpmir~l etching and poliching techniques. In ~ ition, the stent can be surface treated and/or coated with any sui~ble m~ l such as polymeric m~tPn~l found to be bPn~fici~l in providing a surface finish which minimi7es thrombogenicity or ~~st~--os;c or other adverse long or short term effects of stent deployment in 30 colvn~ arteries or other duct-like loc~tionc in the human body. The coating could be a drug or drug-like m~t~ l or could be a coating which accepts drugs of all types which when released in a site ~peçific manner are b~n~Pfici~l to contiguous tissue. Of particular interest would be drugs which are be-nPfiç
when applied in a site spe~-ific l.latmer but have adverse side effects when applied syste-mi~lly. If desired, the coating could also incol~olate additives for 5 drug delivery or other mP~iic~l pul~ses.
The stent accolding to the invention can provide benPfit~ in preventing l}llo,llbog~,c h",onc~ In particular, the stent geolllell~ can be controlled to provide a planar cylindric~l profile when eYr~nded with minim~l strut twisting and oulw~dly protruding stent strut te, .in~l;on~. That is, whereas the struts 10 forming the mesh-like structure of st~inless steel stents have a t~ndency to twist such that the edges thereof project radially oulw~ly when eyr~nd~pd by balloon infl~ti~m, the stent accor~ing to the invention can be eY~r~nd~Pd without such twisting of the struts. Further, colllp~c;d to a st~inlp~ steel stent having the same configuration, the stent according to the invention can be eYr~nd~Pd atlS much lower balloon Pyr~n~ion prcssu~s. The lower eYr~ncion pl~S~ul~S used in acco~ance with the invention ....ni...;~e barut,dullla and the smooth outer cylin~lniç~l surface of the exp~nded stent in accordance with the invention provides non-lh~lllbogcnic plupellies.
The forcgoing has described the principles, ~ere"ed embodiments and 20 modes of operation of the present invention. However, the invention should not be consl,ued as being limited to the particular embo~iimpnt~ di~c~ P~. Thus, the above-desçrihed embo liment~ should be regarded as illustrative rather than restrictive, and it should be app,~ciated that variations may be made in those embodimPnt~ by workers skilled in the art without departing from the scope of 25 the present invention as defined by the following claims.
Claims (12)
1. A permanent tissue supporting device, comprising a stent-like member having an essentially cylindrical, mesh-like shape when expanded, the stent-like member being of a shape-memory alloy which transforms from a martensitic metallurgical state to an austenitic metallurgical state when heatedabove a first transition temperature Af and transforms from the austenitic stateto the martensitic state when cooled below a second transition temperature Mf, the stent-like member being mechanically deformable without plastic deformation in a body passage of a living person from a first configuration while in the martensitic state to a second configuration in the martensitic state and the Af temperature being sufficiently above a body temperature of the livingperson to prevent recovery of the stent-like member to the first configuration by heating the stent-like member above Af without permanently damaging surrounding tissue of the living person, the stent-like member exhibiting a strain on a horizontal plateau of a stress-strain curve of the shape-memory alloy when permanently positioned in the tubular organ.
2. The tissue supporting device according to Claim 1, wherein the stent-like member has a tubular shape with a plurality of slots, each of the slots extending parallel to a central axis of the stent-like member.
3. The tissue supporting device according to Claim 2, wherein the slots are rectangular in shape.
4. The tissue supporting device according to Claim 2, wherein ends of the slots circumferentially adjacent to each other are offset in an axial direction.
5. The tissue supporting device according to Claim 4, wherein the slots form a uniform pattern with at least two axially spaced-apart slots aligned with each other at locations spaced circumferentially around the stent-like member.
6. The tissue supporting device according to Claim 1, wherein the stent-like member inhibits thrombosis when expanded in an artery of a living person.
7. The tissue supporting device according to Claim 1, wherein the stent-like member includes struts and the stent-like member is radially expandable to an expanded configuration wherein the stent-like member has a planar cylindrical profile and the struts are not twisted such that edges thereof project radially outwardly.
8. The tissue supporting device according to Claim 1, wherein the shape-memory alloy is an alloy of Ni and Ti and the stent-like member has inherent radiopacity.
9. The tissue supporting device according to Claim 1, wherein Af~
62°C and the stent-like member includes a coating providing a surface finish which minimizes thrombosis.
62°C and the stent-like member includes a coating providing a surface finish which minimizes thrombosis.
10. The tissue supporting device according to Claim 1, wherein the stent-like member includes at least one hinge-like member extending between adjacent sections of the stent-like member.
11. The tissue supporting device according to Claim 10, wherein the hinge-like member is formed integral with the sections of the stent-like member.
12. The tissue supporting device according to Claim 10, wherein the hinge-like member has an axial length shorter than an axial length of each
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/310,100 US5545210A (en) | 1994-09-22 | 1994-09-22 | Method of implanting a permanent shape memory alloy stent |
| US08/310,100 | 1994-09-22 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2199956A1 true CA2199956A1 (en) | 1996-03-28 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002199956A Abandoned CA2199956A1 (en) | 1994-09-22 | 1995-09-22 | Permanent shape memory alloy stent |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US5545210A (en) |
| EP (1) | EP0782415B1 (en) |
| JP (1) | JPH10508506A (en) |
| AT (1) | ATE255382T1 (en) |
| AU (1) | AU3721795A (en) |
| CA (1) | CA2199956A1 (en) |
| DE (1) | DE69532241D1 (en) |
| WO (1) | WO1996009020A1 (en) |
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-
1994
- 1994-09-22 US US08/310,100 patent/US5545210A/en not_active Expired - Lifetime
-
1995
- 1995-09-22 AT AT95935052T patent/ATE255382T1/en not_active IP Right Cessation
- 1995-09-22 JP JP8511098A patent/JPH10508506A/en not_active Ceased
- 1995-09-22 WO PCT/US1995/012092 patent/WO1996009020A1/en not_active Application Discontinuation
- 1995-09-22 AU AU37217/95A patent/AU3721795A/en not_active Abandoned
- 1995-09-22 CA CA002199956A patent/CA2199956A1/en not_active Abandoned
- 1995-09-22 EP EP95935052A patent/EP0782415B1/en not_active Expired - Lifetime
- 1995-09-22 DE DE69532241T patent/DE69532241D1/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| WO1996009020A1 (en) | 1996-03-28 |
| EP0782415B1 (en) | 2003-12-03 |
| US5545210A (en) | 1996-08-13 |
| DE69532241D1 (en) | 2004-01-15 |
| ATE255382T1 (en) | 2003-12-15 |
| EP0782415A1 (en) | 1997-07-09 |
| JPH10508506A (en) | 1998-08-25 |
| AU3721795A (en) | 1996-04-09 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |