CA2138394A1 - Method and apparatus for making a stent - Google Patents

Abstract

2138394 9400179 PCTABS00030 A stent comprising a coil including a plurality of arcuate sections (40, 42, 50, 52) that alternate directions around a central axis (38) each arcuate section including a pair of curved turns joined by a cusp (48, 58) and the cusps of adjacent arcuate sections intermeshing and defining at least one region of overlap, which in turn describes a helix around and along the length of the coil. In the preferred embodiment, there are two regions of overlap, which together describe a double helix. In another preferred embodiment, the stent is bifurcated so as to support a branched vessel or the like. A method for forming a stent, including the steps of providing a flat sheet of material, chemically etching said sheet to form a blank, and forming said blank into a cylindrical coil, is also disclosed. The coiling step is preferably carried out on a plurality of rollers.

Description

~WO 94/00179 2~ PCT/US93/0582~s ~

MErHOD AND APPARATUS FOR 1~3AKING A STENT `~ ' The present invention is a continuation-in-part of a copending applieation entitled " Artit'icial Support for a Blood Vessel," filed June 18~ 1992 and having Serial Numher 07/900.896.
TECHNICA~ FIELD OF THE INVENTION
The present invention relates to supports for collapsed or occluded hlood vessels~ ~nd more ' particularly, to a coiled wire stent for insertion and expansion in a collapsed or occluded blood vessel. Still more particularly, the present invention relates to a coiled, bit`urcated stent which '':
supports a Y-shaped juncture of two blood vessels. ' ' The present invention further relates to methods and apparatus for manufacturing artificial supports for blood vessels and more particularly~ to methods for making a wire coil having certain desired properties. Still more par~ ularly~ the present invention dis~lo~;es methods and apparatus for preparing a continuous loop and t`orming the loop into a ~:ylindrieal shape having a desired configuration.
BACKGROUND OF THE INVENTION -. ~.
IS A typical wire stent tor insertion and expansion in a collapsed or occluded hlood vessel is shown in U.S. Patent 4.800,882 and includes a coiled wire having a plurality of curved sections that are t'ormed into a generally eir~:ular ~:ontiguration. Ad jacent wrved sections are Joined hy a bend so that a series of alternating opposin, loops are t'ormed. The stent has ~ ~:ylindrical shape with a longitudinal opening through which ~ tolded balloon :atheter is inserted. The opposing loops are tightly contracted about the catheter so that the cylindrical shape has an overlapping region in which portions of adjacent loops circumt'erentially overlap. The loops are arranged so that when the balloon catheter is inflated~ adj;leent loops diverge circumt'erentially relative to each other, thereby decreasing the width ot' the overlapping region while increasing the diameter of the cylindrical shape. As the diameter ot` th~ ~ylindrieal stent iner~ses. the stent eng~g~ the inner surface of the hlood vess~
In operation, the stent is deployed at its desired position within the vessel in its collapsed state. by threading the balloon catheter up the vessel from an in~hiion some dist~nee away. and then expanded to its expanded state, tor supportive engagement with the intérior of the vessel wall~
The prior art stents have several de~lcien(:ies. As shown in Figure 7 of U.S. Patent 4,800,882, the alternating bends are aligned in relation to the longitudinal axis ot`the stent such that upon expansion ot th~ stent ~s sh~-wn in Figure 8. ~he opposing loops m~y he exp~nded su-:h that a longitudinal gap appears between the opposing hends ot` the lo()l)s~ leaving a longitudinal unsupported area along the oecluded blood vessel. Such ~n unsupported area is und~sirable Further, when it is desired to support a hr~n~:hed sætion of a hlood vessel without obstructinn the passageway of the vessel. it is necessary to utilize several conventional stents to support the main '`'.`~
,` '`., wo94/onl79 ~ Pcr/llS93/u58z3 vessel and the adjaeent two branch vessels. Deployment ot` multiple stents re4uires an extended medical procedbre:j and may produce unsatisfactory results it' any of the stent~ migrates away t'rom the juncture, leavin one leg of the Y-shaped juncture nt` the vessels unsupporled. Additionally~
the stents of the prior art often require the application of heat~ torsion~l t'oree~ or a shortening in length in order to attain their expanded state.
Alternatively, stents having no longitudinal gap may he compris~ spiral eoils. or other configurations that are radially expandable and provide the desired cir~umt'~renti~l support t`or collapsed vessel.
Because of the asymmetrical nature of many of the desired coil eonfigurations~ standard manufacturing methods are inapplicable. Thus. stents such as that diselosed in U.S. Patent 4,800,882, involve a high degree of labor to produce. The present invention discloses means and apparatus for producing ~ desired s~ent 4uickly an(l easily.
The present invention overeomes the det'ieieneies ot` the prior art.
SUMMARY OF THE INVENTION
The stént of the present invention l:omprises a eoil including a plurality ot` areuate sections that alternate clockwise and eounterelockwise directions around a ~entral longitudinal axis Ea~h arcuate section includes a pair ot` curved turns joined hy ~ eusp. The eusps ot adjaeent areuate sections intermesh, thereby det'ining at least one region ot overlap~ whi~:h in turn deserit)es a helix around and along the length of the coil. In the pret`erred emhodiment. there are two regions of overlap, which together form a douhle helix.
The present invention furthér discloses a Y-shaped~ hit`urcated stent. The hit`urcated stent comprises three eoils, each constru~t~d ~e~ording to a pret'erre(l ~oil pattern~ joine~l so as to torm an unobstructed support t`or a hranched vessel.
The stent of the present invention is radially expandahle without the use of heat~ torsional forces, or shortening of the stent. and is eonstructed to provide a region ot enhanced support which wraps helically around the stent. The branched stent fills the need t`or a reliahle device which is simple to install and effectively supports a branched blood vessel.
The present invention further diseloses a douhle-spiral stent that mav eomprise either a single eoil or a bit'ur~a~e-l eoil. ~nd ~ rih-e~ ype st~n~ that in~lud~s a lon itudinal spine supporting a plurality ot' looped rihs thereon.
Also disclosed is a method t'or making the t'oregoing stents that is rapid~ repeatahle and economical. The method ot' the present invention is not lahor intensive and is eapahk ot' producing even stents that do not have a lin~r axis ot symm~try. The present method includes creating a conlinuous loop, or blank~ hy photoetching a sheet ot` material. The blank produced by the .: . .
'~`' : !WO 94/00179 2138~94 PCI/US93/0582~ ~

photoetching technique has no ends or joints and is therefore superior tor internal applications , ~
because the likelihood of a puncture or other damage is minimized. - : -The present method further includes rolling the continuou~ hlar.k hetween a series ot`
rollers, to form a cylindrical coil. According to the present invention~ the precise configuration :
of the coil is determined by the shape of the blank that is rolled. Thus~ single-helix, double-helix and spiral configured stents may be constructed by rolling aceording to the present inventiom Alternatively, a method for constructing the desired coil shape hy hand is disclosed. The manual method comprises forming each loop of the coil around a mandril hy individually pulling the cusps of the coil into plaee. This manual method may of course be automated to increase speed and efficiency of production.
Other objects and advantages of the present invention will appear from the t`ollowing description. ~ ~ ~
BRIEF DESCRIPTION OF THE DRAWINGS ~ .
For a detailed description l)f a preferred emhodiment uf the invention. ret`erence will now be made to the accompanying drawings wherein:
Figure I is a perspective view of a douhle-hélix nonhifurcated stent according to the present ` -invention.
Figure 2 is an end view of the douhle-helix nonhifurc~ted stent ~)f Figure 1.
Figure 3 is an enlarged view of two full loops of the douhle-helix stent nf Figure I.
Figure 4 is a close-up view of two t`ull loops of the douhle-helix stent of Figure 1. r'' Figure S is a perspe~tive view ot` a single-helix nonhit`urcated stent.
Figure 6 is a perspective view ot` a douhle-helix hitureated stent aceor-ling to the present -:
invention.
Figure 7 is a perspective view ot` a hit`ure~ted stent in which the major .:oil is a douhle-helix and the two minor coils are single-helix.
Figure 8 is a side elevational view ot the stent of Fi_ure 6 in a :ollapsed state~ mounted - ~
on a balloon catheter within a blood vessel. - ` -Figure 9 is a side elevational view ot the stent of Figure 6 depl-)yed within a hit`urcated vessel and partially expanded. `
Figure 10 is a perspective view of a tirst nont)iturcated cross-over stent.
Figure 11 is ~ perspective view ot a se(:ond nonhifurcated eross-l)wr stent. " `
Figure 12 is ~ perspe(:tive view of a hihln:ated zig-za~ stent accl)rding to the present inventi(~n. ~ ;
Figure 13 is an enlarg~l view ot two ot the loops ot` the zig-zag slent ot Figure 1 Figure l~ is an is~metril: view ot a nonhiturcated rihhon stent.

3 ~ - ;```

WO 94/00179 ~138394 PCI /VS93/0~82?5 ~~

Figure 15 is an isometric view of a biturcated ribbon stent.
Figure l6 is a perspective view of a double-spiral ss~nt made aceording to the present invention;
Figure 17 is a perspective view of a bifurcated douhle-spiral stent made according to the present invention;
Figure 18 is a perspective view of a hifurcated stent in which the major ~:oil is a douhle-spiral and the minor coils are single spirals~
Figure 19 is an perspective view of a continuous loop blank that may be used to torm the stents of Figures 16 and 17;
Figure 19A is a cross section of the blank of Figure 19 taken along lines A-A of Figure 19;
Figure 20 is an elevational view of a continuous loop hlank that may t-e used to form the stents of Figures l and 6;
Figure 2~ is a perspective view ot` a ba-:khone blanl;;
Figure 22 is an end view of an apparatus that can he used according to the present . .~-.
invention to produce the stents of Figures I, 5, 6, 7~ 16, 17. and 2 l; . `
Figure 23 is a perspective view ut` the apparatus ot Figure 22 torming the loop of Figure --19 into the stent of Figure 16; .
Figure 24 is a perspective view of the apparatus of Figure 22 t`orming the loop of Figure 20 into the stent of Figure 1. and .-Figur~ 25 is a perspectiv~ vi~w of a st~nt form~d t`rom the rih-.:a~ hlanl; ot` Figure 21. -DETAILED DESCRIPTION OF A PREFERRED EMBO~IMENT .
Douhle Helix Stent Ret`erring initially to Figures I and 2, there is shown a preterred emt)odiment ot` a stent l0 according to the present inventiom Stent l0 is made of a single length of wire having a mid-point - at 12 torming two wire legs 14, 16 of approximately equal léngth. Legs l4. 16 are bent into a .`.
double-helix coil 22 as shown, torming individual spiral wire shell halves 18. 20 respectively. One ` -end 24 of coil 22 includes mid-point 1'. and the other end 26 ot coil 22 includes the terminal ends .. ~.:
28~ 30 of wire legs 14, 16. Terminal ends 28. 30 are connected at juncture 32 on coil end 26~ ` `
such as by soldering or the like. Upon the joining ot` terminal ends 28~ 30~ coil 22 effectively consists of a single continuous wire 34. The two wire shell halves 18. 20 are curved, as shown ..
. - .
in the end view ot` Figure 2, so that stent 10 is generall~ cylindrical in shape w ith a generally : :~
circular opening 36 t`ormed therein~ Stent lt) is shown having a central longitudinal axis 38 Referring now to Figure~ 1. 3~ and 4. ea~:h inùividual ~piral wire Shell h~lt 18. 20 include~
a series of alternating clockwise and count~rclocl;wise ar-:uate secti(ln~. For purr)oses ot : .. `

:WO94/~)~)179 Z13839'~ PCI`/1)593/058~?i description, the arcuate sections have been severed in Figure 3 to betler illustrate such sections.
The clockwise direction relative to the axis 38 has been arhitrarily selected and is indicated ~y the arrow CW. Wire shell half 18 includes alternating clockwise and counterclockwise arcuate sections 40, 42, respectively, and opposed wire shell half 20 includes al~ern~lino ~ounterclockwise ~nd S clockwise arcuate sections S0, 52, respectively. Clockwise ar-:uate section 40 is ~ypie~l ot` the other arcuate sections and includes two adjacent curved turns 44, 46 of wire joined hy ~ hend or cusp 48. Likewise, counterclockwise arcuate section S0 of shell half 20 includes two ad jacent curved turns 54, 56 joined by a cusp 58.
As best seen in Figur~ 1, wire leg 14 forms shell half 18. comprising clockwise arcuate sections 40a, 40b, 40c, etc., with cusps 48 pointing in the clockwise direction and counterclockwise arcuate sections 42a, 42b, 42c~ et.:.~ with cusps 48 pointing in the opposite counterclockwise direction. Likewise. wire leo 16 torms shell hall 20 comprising counterclockwise ~r~:uate sections 50a, 50b, SOc, etc. with cusps 58 and clockwise ar-:uate sections 52~, 52h~ S~ et~. with cusps 58.
The clockwise arcuate sections 40 of shell h~lt` 18 are in phase with the counterl:lockwise arcuate sections 50 of shell half 20 so that the clockwise arcuate sections 40 of halt 18 intermesh and extend hetween counterclockwise arcuate sections 50 of half 20. The same is true for counterclockwise arcuate sections 42 of half 18 and clockwise arcuate sections 52 of half 20.
Ret`erring now to Figure 4~ the in~ermeshing ot ~rcu~te sections 40~ S0 and 12~ 52 creates two regions of overlap in coil 22. Clockwise ~reu~te se~tions 40 ~nd ~:ount~rclockwise ~F~u~e sections 50 create a first overlap region 60 ~n ~ ounterclockwise areu~te seetions ~2 ~nd clockwise arcuate sections 52 create a second overlap region 70. Regions ot overlap 60~ 70 have diametrically opposed eenterlines 62. 72~ respectively.
Referring now to Figures I and 4. the extent of the regions of overlap 60. 70 will vary with the size of the hlood vl~ssel in which the stent 10 is deploye(l. The extenl ot the region of overlap 60. 70 is maximized in the contrac.ed r)osition of the stent 10 and is minimized in the expanded position of the s~ent 10. The inl~rmeshing ot` ad ja~:em arl:uale seclions 40. 50 and 42~ 52 defines an angle c~ at axis 38~ shown in Figure 1. Pret`erahly. in th~ ~:ontracl~d posilion. cY is al least tive longitudinal degrees. In Ihe Figures~ an inlermeshing ot`(jnly a t`ew longiludin~l degrees is shown, but it will be understood that the degree ot` intermeshing can he increased without departing from the spirit ot the invention and is actually increased when the stent is used. Cusps 48~ 58 of arcuate sections 40~ 42~ 50~ 52 shift circumt`erentially with e~-:h turn. In this manner. regions o t overlap 60, 70 descrihe a double-helix ~round c()il 22, hesl demonstrated hy retdrence cenlerlines 62~ 72, shown in Figure I. The advanlages of this construction will h~com~ apparent t`rom the dis-:ussion below.

Z~3839~
WO 94/00179 PCI/US93/0582?~

.`7 ~
Preferably, stent 10 is constructed of wire. although any suit~hle material may be substituted. The wire comprisin~, stent 10 is malleahle~ preferahly t`rom the group consisting of annealed stainless steel, tungsten and plalinum. This malleahle material must he sut`ficiently deformable to allow shell halves 18, 20 to expand radially when radially outward pressure is 5 applied by the inflation of the membrane that comprises the standard hallnon catheler. Because the stent material deforms plastically, rather than elastically~ the stent 10 retains the enlarged diameter aRer the balloon is deflated.
The material has sufficient strength and stiffness, however~ to avoid the stent 10 being displaced during insertion and to avoid the adjacent arcuate secliuns 40, 50 and 4~ 52 being torced into an overlying relation. Further, the stent 10 has sufficient strength and stittness to allow it to maintain its position in the vessel passageway an(l to resist heing diclodged atter the catheter has been deployed. One example of a suitahle wire has an outer diameter of 0.018 inches and is stainless steel AISI 315 alloy. Alternately, the stent 10 ot th~ present invention c~n he constructed of a memory metal, such as Nitinol~ that resumes a particular original shape~ t`ollowing deformation, when heat is applied.
In a pret`erred emhodiment, the surt`ace ot the stent is coaled with a hiocompatible substance~ pret`erahly a biolized collagen/gelatin coml-ound such as those diseussed in CharacterizatlonofR~h!~lrat~cl C~'kllinC~ Emot~net~ Arlih~i~lOr,(,~lln. 15tl):~9-34~ 1991 and incorporated herein hy ret`erence. The coating s~rvec tO incre~se hiocompatihility ot the stent and aid in blood flow around the device. The coating is a 5% glutaraldehyde cross-linked dried gelatin coating which can t e applied to a texturized surt`ace~ dehy(lrated~ sterilized~ and stored dry.
This type ot` gel~ when applied as a tilm~ l)rovides ~ smooth~ hiochemieally stahle protein coating with non-pseudointima properties~ very little platelet adhesiom and hi~h hlood compatihility.
To deploy a stent such as the stent 10 of Figure I in a hlood vt~ssel~ the stent is radially contracted or compresseLI until it a.csumes ~ outer diameter which is c~lihrat~ to allow insertion into a particular vessel passageway. Typically~ this means an outer diameter on the order of 3 millimeters. With regard to stent 10~ as the stent is compressed~ regions of overlap 60~ 70 widen and the cusps 48~ 58 are t`orced into deeper intermeshinn relationshil-. The sten~ 10 in its contracted state is threaded onto a halloon catheter (not shownJ prior to deployment in the vessel.
The compressed stent 10 and catheter are inserted at an ineision in the vessel and threaded up the vessel on a wire guide to th~ plaee of deployment. At that point~ pressure is applied to the halloon to expand it within the stent. As the hall~on is int1ated~ the clockwise and counter-clo(:kwise arcuate sections 40~ 50 and 4~ exr)and radially~ reducing the width ot` overlap regions 60~ 70 until the desired circumterence is attained. Thus~ the ett`ective diameter ot` stent 10 is increased ~3~94 :~-) WO 94/00179 PCr/US93/05823 - without thermal expansion~ application of Iorsional forces to the stent. or ~ reduction in overall length of the stent.
Sin~le Helix Stent Referring now to Figure 5, there is shown an alt~rnat~ nonbit`ur~:ated stent 61 comprising S a single helix coil 64. According to this embodiment, ~ wir~ is bent into ~ s~ri~s ot' al~rnating clockwise and countercloc~wise arcuate sections 63, 65. t`ormed by turns 66 and cusps 68. such that one region of overlap 71 is formed. The ends 67, 69 ot` the wire are iocated at opposite ends of coil 64. As described above with regard tO stent 10. arcu~te sections 63. 65 are constructed so that region of overlap 71 shifts longitudinally with each successive turn 66 and t`orms a spiral around coil 64. Because there is only one region of overlap. 71, coil 64 is referr~d to as a single~
helix coil. Stent 61 can he deployed in the manner discussed ahove with regard to stent 10.
Referring now to Figure 6, there is shown a pret`erred hit'urcated stent 80 according to the present invention. Bifur~ated stent 80 includes a m~jor c()il 8 and two minor coils 84. 86, In practice, major coil 82 may be placed~ for ex~mple, in the aortic vessel and minor coils 84~ 86 in the iliac vessels, As with stent 10, hifurcated stent 80 eomprises a single continuous wire 34, and each of coils 82~ 84, 86 comprises a part ot` the wire 3~. Major ~oil 8~ has the same douhle helix pattern as coil 22 of stent 10, with the exception that wire legs 14. 16 ~re extended to form minor coils 84. 86. respectively. which are also coiled in the douhl~ h~lix p~ttern of coil 2'~. As in coil 22, the terminal ends 88, 90 ot' wire legs 14. 16 ~re ,joined at a ,juncture 9~. Hence. a single wire loop is able to define and flexibly support a hranched vessel without ohstructing flow therethrough.
Ret`erring now to Figur~ 7, an ~Itern~te bit'ur-:ated stent 81 comprises one major eoil 83 constructed in the manner of douhle-helix ~:oil '~ of stent 10 shown in Figllre 1. and two minor coils 85, 87 conslructed in the manner ot' sing~le-helix coil 61 ot' stent 61 shown in Figure 5. As with bifurcated stent 80. bit'urcated stent 81 ~n he constructed t`rom ~ single piece ot' wire. In stent 81, wire le~gs 14, 16 termin~Ie ~t ends 88. 90~ which m~y b~ joined to ~oils 8~, 87, as shown at 91~ individually t`ormed into loops ~not sh(~wn), or oth~rwise prev~nted t`rom puncturing the vessel wall.
Deployment of a hifurcatecl stent is shown in Figures 8 and 9. usin~ the stent 80 shown in Figure 6. Stent 80, in a contracted state on halloon catheter 11', is threaded up one of the iliac vessels 108. 110 t'rom an incision in the leg. as shown in Fiu~ure 8. When it reaches the juncture 106 ot' vessels 108.110~ the stent 80 is push~d up into the aortic vessel 100 hy a guide wire 10 until one of the minor coils 8~86 ot' th~ stent 80 is :lear ot' th~ ,junctur~ 106. Then the stent 80.
still in a compr~ssed stat~ is ba-:ke-l down th~ iliac vessel 108 until it is in its pr~-per position t`or expansion. Figure 9'shows stent 80 in position ,t'or deployment ~vithin the vessel ,juncture 106 and , . ~
. : . .. : ~ : - : . .

2~8394 WO 94/0~179 PCT/US93/0582?~ ~
. s partially expanded. Bifurcated stents of the present inventiun h~ving a v~riety of coil patterns m~y be deployed in the manner described above with respect to stent 80.
As shown in Figures 8 and 9, a tri-wing balloon 112 may be used to inflate stent 80~ so that uniform pressure is applied to each coil ot stent 80 and the coils expand simultaneously. The S balloon material is flexible~ so that, once deflated, it may he easily remuv~(l through dny )pening in the stent 80. Preferahly, it is removed through an opening where the aorti~ se~tion hran~hes ~o form the iliac sections, or through the end of one ot the ilia~: seclions.
Cross-Over Stents Ret`erring now to Figure 10, an additional single-helix. nonhit`urcated coil 120~ is shown 10 ln coil 120, both wire ends 88, 90 are at one end of the coil 120, and one regiun of overlap 130 is formed. In alternate emhodiments ot eoil 120 (not shown)~ wire ends 88~ 90 may be joined as at 32 in Figure 1, formed into loops, or extended to form integral adJacent minor coils. Region ot` overlap 130 deserihes ~ helix ~round ~:oil 120~ ~s :lis.:ussell ahove with respect to coil ~
Unlike coil 22, however, where the materi~l torms twu uppusing in :lividual shell halves that do nut 15 cross, the material ot coil 120 torms twu generally cylindrh:al legs 124~ 126~ each comprisin of a series of alternating clockwise and counter-clockwise sections 132~ 134 having clockwise and counter-clockwise cusps 133~ 135~ respectively. Each leg 1?4~ 126 has its own region ot`overlap, and legs 124, 126 are intermeshed so that the regions ot` overlap ~:oincide. When intermeshed~ legs 124, 126 cross each other at a series ot` cross-overs 128~ For this reason~ coils such as coil 120 20 are hereinat`ter ret`erred to as cross-over coils~ It should he noted that in coil 120 :lockwise cusps 133 and counterclockwise eusps 13~ ~Itern~le ~lon~ reOion ot overl~r) 130.
Coil 120 provides a radially exp~ndahle eoil with an ~symmetri~al reOion ot` overlap~ The fact thal both wire ends 88~ 90 are al one end ot` coil 120 makes coil 120 suilable t`ur the construction of either a closed loop, nonhiturcaIed stent or ~ hit`urcated stent in whi~h the minor 2~ coils are tnrmed trom~ and are theret`ore integral with~ ends 88 and 90.
Reterring now to Figure 11~ an alternate sin~le-helix~ crosst)ver~ nonhit`urcaIed coil 120, is showm In coil 1'2~ as in eoil 120~ hoIh wire ends 88~ 90 are al one end ot` the coil 1~ and one region ot` overlap 130 is t`ormed. Region ot` overlap 130 descrihes a helix around eoil 122~ as discussed above with respecI to coil 120. As in coil 12U~ the material ot` coil 122 t`orms two 30 generally ~ylindri~al legs 124~ 126~ eaeh ~omprising ot a series ot` alternatinD clockwise and counter-clockwise sections 132~ 134 having clo kwise an(l coumer-clt)ckwise ~usps 133~ 13~
respectively. Each leg 124~ 126 has iIS own region ot overlap~ and legs 12~ 126 are imermeshe(l so that the regions of overlap coineide~ When intermeshe:l. Iegs 12~ 126 cross each oIher al a-series of cross-overs 128. Wire ends 88~ 90 ot coil 122 may he treate(i in Ihe same manner as 35 discussed ahove with regard I0 coil 120.

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- In coil 122, however, unlike coil 120, a pair of clockwise cusps t33 is tollowed hy a pair of counterclockwise cusps 135 etc., defining region of overlap 130 in a manner different from coil 120. The difference arises in the pitch of the turns of each leg. In coil 120, the turns have an uneven pitch, in that one leg 126 t`orms a first pair of adjacen; cusps 135a~ 133a and then passes behind the other leg 124, which forms the next pair of adjacent cusps 135h~ 133h~ and so on. In coil 122, the turns of each leg hàve a regular pitch~ hut do not form the alternating clockwise~
counterclockwise pattern of cusps at region of overlap 130.
zio-zao Stent In another alternate embodiment, shown in Figure 12, a hifurcated stent 140 comprises three radially expandable cylinders 14~, 144, 146 formed of wire in a zig-zao pattern. The diameter of minor cylinders 144~ 146 is approximately half the diameter (~f major cylinder 14~ and minor cylinders 144~ 146 are mounted adjacent to one another at one end of major cylinder 142.
so as to provide support tor a hranched ves~el without ohs~ru~ing tluid tlow therethrough. The attachment of minor cylinders 144, 146 lo major cylinder 142 may he by any suitahle means~ such as by t`orming a loop or hinge to provide a flexihle joint~ or by soldering the coils together.
As best seen in Figure 13. zig-zag stent 140 ~:omprises a plurality of straight sections 147 joined by a series of loops 148~ with a crossover 149 corresponding to each loop 148. The wire reverses directions at each loop 148~ so that each straight section 116 crosses the two adjacent straight sections at cross-overs 149, tormin~ a zig-zag pattern. A stent ot this contiguration has no longitudinal gap when expanded.
Stent 140 is radially expandahle without thermal exrlansion or the application ot` torsional forces to the stent. The loops avoid sharp hends in the wire which might otherwise occur between adjacent straight sections~ and, by enabling the straight wire sections to be crossed~ increase the strength and stability of the stent. Additionally. zig-zag stent 140 can be constructed of a single~
continuous piece of wire~ with the wire passin, torm major cylinder 14~ to each minor cylinder 144. 146 and hack at least once Spiral Stent Reterring now to Figures 14 and 15~ an alternate emhodiment of the present invention comprises a bifurcated stent 150 tormed t`rom a single. rihhon-iike piece ot` material 152~ The material used may be a solid strip ot sui~ahly det`ormahle metal or plastic or o~her hiocompatible substance, or it may be a mesh. such as ot woven me(al threads~ To torm a single coil 154, a strip of material having a desired width is woun(l aroun(l an ~xis 151. To torm hit`un:ated stent 150~
when the desired len_th of single coil 15~ is attaine(l~ the rem~ining~ unct)iled length of the strip is split lengthwise into two minor strips 155~ 156~ whi.:h are each coiled into a smaller hut similar coil 158~ 160.

WO 94/00179 Z138~94 PCI`/US93/05823 ~' It will be understood that a bifurcaled stent may be constructed by combinalions of the coil patterns disclosed herein other than the combinations shown in Figures 5 ~nd 9. For example. the : `
coil of Figure 1, which is shown as a closed loop, ~ould he opened and ~omhined with two minor coils such as coils 83~ 85. Such a ~:ombination would t`orm a hitur-:aled sten~ t`rom a single pie~e of wire with she wire ends terminating at the ends ot the min(lr ~oils. These :omhinations ~lo no~ `:
depart t`rom the spirit of the invention. `
The advantages of a stent coiled according to the ahove descriptiom and in parti~ular a ~:
.. .. .
bifurcated stent, are discussed below. Primarily, the present coil is an improvement on the art because the relative stiffness of the regions of overlap and the turns are distrihuted longitudinally evenly about the axis of the coils. This is advantageous~ as it is preferahle that a stent not have a bias toward bending in one direction over another.
When a stent constructed ac-:ording~ to the present invention is expanded into its supporting state~ the outside diameter of the coil increased hy decreasing the width of the regions of overlap.
If the stent is expanded too much~ the regions ot` overlap will disappear, as the intermeshed cusps will no longer overlap longitudinally. In the prior art this resulted in a longitudinal gap in the stent. across which the blood vessel was not supported. According to the present invention~ even if the stent is expanded to such an extent that a gap is tormed~ the gap is helical~ winding around the length of the .stent. It is helieved thal ~ helic~l gap is preterahle t`r(lm a me(liwl standpoint.
Because the stem ot the present invention can he uons~ructed trom ~ continuous loop ot`
wire, it eliminates the wire ends that are commonly present on the stents ot` the prior art. Such wire ends must he bent into loops~ or otherwise treated~ s~- as to decrease the likelihnod (lt puncturing the vessel wall.
Douhle Sniral Stents Reterring now to Figure 16~ a stent 100 having a douhle-spiral c(lnt`iguration~ as opposed to à douhle-helix~ is shown. As discussed ah(lve with resr)ect to stent 10~ stent 100 is pret`erahly tormed t`rom a single ~:ontinuous loop 102~ such ~s that sho- n in Fiuure 19 and discussed below.
Loop 102 is twisted ahout an axis 104~ such th~t a cylindric~ oil having ends 106 and 108 and side sections 110 ànd 112 is t`ormed. Each side section 110~ I 12 torms a spiral~ with the two spirals heing diametrically opposed except at ends 106~ 108. Like stents 10 and 80, stent 100 provides uniform support around the eir~:umteren~e of a vessel. That is~ it has no longitudinal gap Unlike stents 10 and 80~ however~ stent 100 shortens or unwinds as it expands. This is a result of the spiral ~:onstruetion ot` slent 100.
Again usinV spir~ onslru~tiom ~ hit`ur~ tJ ~lent 1'0. ~s shown in Fh ur~ 17~ m~! he formed. Bit`ureated st~nt 120 in~:ludes ~ dt)uhl~-slliral major ~oil 1" ~nd two douhle-sr)ir~l minor .:

' ~~ WO 94J00179 213839~ PCI /IJS93/0582~
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coils 124, 126. Stent 120 is pret'erably formed t'rom a single ~:ontinuous loop 1~8~ and major coil '~.' ' 122 and minor coils 124, 126 are t'ormed in the same manner as stent 100. ':
According to an alternate embodiment, shown in Figure 18~ loop 128 may be cut at one '` ' end of major coil 12~, and the resulting ends 130, 13~ m~y h~ individually coiled into single - ' spirals. In this embodiment it is preferred that the exposed ends be looped hack and connected to ~ '' their respective coils in order to reduce the possihility of their puncturing the ~essel in which they `' are installed, as at 134. ' ' Methods of Makin~
According to the present inventiom stents such as those descrihed ahove are t'ormed in a two-step process. The first step entails constructing a ~:ontinuous loop~ or hl;~nk~ in the desired ~i shape, while the second step entails t'ormin~ the hlank into a ~vlindrical ~:oil. Methods t'or carrying out each step are described in detail helow. I `
A. Forming a Continuous Loop or Blank Continuous flat loops~ or hlanks~ such as those shown in Figures 19 and ~0~ are pret`erahly `~;~
used to t`orm the stents disclosed ahove. A-:cording to a pret`erred emhodiment~ each hlank is formed by a photo-etching process. In this process~ a drawing1 is made ot the desired hlank shape.
The drawing is then reduced to actual size. The reduced drawing is used to produce a mask having the eontours of the finished product. This mask is then at`t;xed to the suhstance to be t`ormed, pret`erahly by means ot an adhesive. The masked suhstance is exposed to an etching chemical~
which eauses those portions ot` the suhstance that are not (:overed by the mask to he dissolved. The etching chemicàl is pret`erahly an aeid-hase suhstance~ such as are widely availahle. The selection and strength of the etching chemh:al will he delermined hy the composition ot` the suhstance to he etched.
Allernatively~ the blank may he tormed hy laser-etching a sheet ot the suhstance out of which the stent is to he c-)nstructed. La~er-etching i~; a con~entional cllttin~ te-:hni4u~ the details of whieh are well-known in th~ art. ~' The suhstance that is etched can he any ot` various metals or metal alloys having the desired properties. For example. in some instànces it may he pret`erahle to use stainless steel in the manut:acture of the stent~ hecau~e of its stren~th an~ orrosion resistance. In other eases~ h :~
memory metal~ such as Nitinol, may he used. ' .
If a memory metal is used to torm the stent. its shape-retaininn properties eàn he used to - '' advantage in two ways. First. it' a stent in the austenitic condition is tormed into the desired stent shape and allowed to cool into martensite. il :an he comr)r~ssed or collar)sed t`or deployment. ~, Collapsing of the stent det~)rms the martensite~ which retains the collapsed shape. The collàpsed - -stent can he deployed and then expanded hy a hriet` ap~ ation ot' heat~ therehy ohviating the need X~383g~
WO 94/001 79 . . t ' PCr/US93/0582 : . ,-for a balloon. This would be particularly advantageous in instances wh~re it is desirahle to deploy and expand a bifurcated stent, as it avoids the need to position and then rem-)ve a Y-shaped balloon.
The second uset'ul application ot' memory metals in v~ ular ~ur~r-on is where it i~ d~sired S to expand a vessel whose diameter has decreased to an unsafe de;,ree. In these instances~ an austenitic s~ent is pret`ormed such that it has a diameter slightly greater than that ot`the l:ollapsed vessel into which it is to be deployed. The material is selected so that it is "super-elastic" in the temperature range of the human body. Because the materi~l is theret`ore springy and can be subjected to significant stress without det'ormation~ the stent c~n he collapsed and deployed without the use of heat. Because the material does not deform durino~ ~ollapse~ it must he contained in a catheter tha~ is capahle of resistin,, the expansive spring t`oree ot the stent. On~e deployed. hecause the diameter of the stent is larger than th~ ~essel diameter~ th~ stent exerts a dilative radial t`orce on the vessel wall. This causes the vessel tn exr)and until the stent is t'ully expanLled. This would eliminate the present need to use balloons t~ expand a collapsed vessels and/or collapsed stents.
Once etching is complete, the m~sk is remov~d~ leaving only the cleanly cut metal hlank 150, as shown in Figures 19 and 20. Each hlank includes a pair ot` ends 152 and a pair ot' legs lS4 extending between ends 1~2. Because the starting material k)r the mask typically comprises a flat sheet~ mask 150 will hav~ ~ r~ctangular cr~ss-~eetion, ~s shown in Figure 19A. The thi-:kness of the sheet of starting material will determine th~ thickness ot` hlank IS0.
It will he n~ted that the legs 15~ ot' hlank 150 shown Figur~ 19 are essentially straight~
except where they curve together at ends 15~. In contrast~ each leg 154 ot` hlank 150 of Figure 20 is cut into an inclined, serpentin~ shape. Each serpentine leg torms cusps 155~ which are designed to intermesh when the hlank is t'orme(l into a cylin(lri~ al coil.
Still another type ot` blank that ean he etched and tormed according~ to the present invention is the rih-cage blank 160 shown in Figure ' I . This hlank in-:ludes a longitudinal spine 16~ with a plurality of looped rihs 164 cxtending theret`rom. Rihs 16~ ~r~ pret`erahly suhst~ntially U-shaped~
as shown. in order to minimize turhulence in th~ tluid p~ssin throu~ h th~ stented vessel~ to maximize conformahility of the stent to the interior (jt' the vessel~ and to minimize the likelihood of a puncture.
Other methods t`or tormin~, a eontinuous hlank may alternatively he employed. For example~ two ends of a piece ot' wire may he sol(l~r~d or w~lded and then maehined to produce a smooth couplim~ ~luwever these methods tor torming are less desired hecause they require additional manut`acturinn steps and do not p rodllce an integral piece as d(-es photoetching B. Coiling the Blank intn a Stent 1~ .

- "1W0 94~00179 2~3~39~ PCI~/US93/0582?s Once blank I50 has been formed. it is shaped into its ultimate cylindrh:al torm by one of the following methods.
Preferably, a plurality of secondary rollers 201-204 may he used ds ~ihown in Figure 22 to wrap blank 150 around a drive roller or mandril ~10. Secnnddry roller~ 201-204 are positioned so that they do not contact each other and are spaced slightly apart t`rom and parallel to drive roller 210. The space between each secondary roller 201-204 and drive roller ~10 is preterahly equal ~o or slightly less than the thickness of blank 150.
As shown in Figure 22, blank 150 is fed at a steady rate into the gap ~11 hetween the first secondary roller 201 and drive roll~r 210. The rvtating surt:dces of thes~ two rollers propel hlank 150 toward the succeeding gap 212 between secondarv roller 202 and dri~e roller )10. The rotating surt`aces vt` these two rvllers in turn propel hlank 150 low~rd su~:eedin;, gdp 213. In thi~
manner~ blank 150 is propelled completely around drive roller ~10. The passage ot hlank 150 around one circumt`erence ot` roller 210 results in blank 150 assumingJ a cylindrical shape.
If hlank i50 is fed at an ohli(lue dngle wilh respe~:t to the ~xis ot` drive roller 21 0 as shown in Figure 23, the opposite edges or sides ot` hlank 150 and the gap défined therehetween will form a longitudinal spiral arollnd the drive roller~ It a hlank having straight sides is used. such as is shown in Figure 19. a double-spiral stent like that shown in Figure 16 will he tormed. If.
however. a serpentine hlank i~ used, such ~s is shown in Figure ~0~ ~ douhle helix stent like that shown in Figure I will he tormed. The positioning ot eusps 155 ot each leg 151 with respect to cusps 155 of the other leg 154 will determine the pattern of cireumt`erential support provided by the stent to the vessel~ It has heen tound that an sl~nt~d s~rpentine hlank like that of Figure 20 will produce the desired douhle helix stent in whi~:h the longitu(Jinal gap or region of overlap hetween the cusps defines a spiral around the sten~
As abov~. rih-eage bl~nl; 160 m~y ~hi.~ he t~d int~ th~ rolling meih~nism l~ h~ tormed into a cylindrical shape. Reterring now to Figur~ ~5~ it` hlank 160 is t`ed inl~ th~ rollers ohli4uely~
spine 162 will descrihe a spiral an(l rihs 16~ will intermesh t~ more l~ompletely detine the desired cylindrical shape. Alternatively~ hlank 160 may he t`nrmed into the desired shape hy other mechanical means.
It will be recognized hy one sl~illed in th~ art that the toregoing method is superior to prior methods of formin~, a ,:omplex stent such ~s the douhl~-helix stent~ in that the present method allows rapid~ consistenl~ and symmetrieal assemhly ~)t` the desired shape and is not lahor intensive.
If, however~ the necessary e~luipment is un~vailahle~ the stents disclosed ahove may he t`ormed "hy hand." such as hy manu~lly wr~ppim~ or pulling the hl~nk into shape around a mandril.
While the t`oregoin~ stents descrihed may he used alone~ particulariy it they are coated with a biocompatihilized ~el as descrihe(J ahove. it m~y optionall!~ he desired to provide a casing tor the 1.

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deployed stent. Such ~ casing. or gratt ~s lh~y ar~ ealled. m~y ~:ompris~ a Iuh~-sh~p~d memher having an inside diameter only slightly larn~l than th~ circumt`~rence ot` the d~ployed stent. The ~ . .
casing may be mad~ ot lat~, silicone latex~ polytetrat1Ouroethylen~ polyethylene. dacron polyesters. polyurethane or other suitahle hiocompatihle m~terial. The graft material must he 5 flexible and durable, so that it can withstand the ettect~ of installation ~nd usag~. Depending on the material chosen, it may be preferahle to torm the grat`t in one ot several ways. For example, the grat`t may be extruded~ woven or t`ormed hy dippino ~ suhstrat~ in the desired material~
removing the material from the suhstrate~ and trimming the end ot` the material~ so as to t`orm a cylindrical tube having an opening ~t each end.
The graft is deployed simultaneously with the deployment ot the stent. Prior to deployment. the gratt is collapsed~ with the eollar)sed ~tenl inside it. As des~rihed~ the stent and graft may then he inserted into a ~atheter~ deployed~ and expanded hy pressurization of a halloom A graft deployed and supported in this mann~r may he us~d l~- seal an an~urysm or similar det`ect in a vessel. The tissue ot the vessel ad jacenl to the gratt will grow ont~- Ihe gra~`t~ so that the graft 1~ becomes an integral~ reint`orcing that part ot the vessel wall and helping to reduce the risk ot t`uture rupturès at that locatiom While a preterred emhodiment ot` th~ invention has heen shown and descrihed, modifications thereof can he m~de hy one skilled in the art without departing t`rom the spirit ot the invention. It will further be understood that stents according tO the present invention may he used 20 in other body passageways~ such as ~he urinary~ hiliary~ or esopha~eal tract~ with construction and deploymen~ of the stents heing essentially as des-:rih~(l ahov~.

:

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Claims (10)

Claims What is claimed is:

1. A stent for supporting a blood vessel, comprising:
a single length of material comprising a continuous loop;
said material being bent to form a coil about a longitudinal axis, said coil defining a helix around said longitudinal axis; and said coil being such that said material does not cross itself at any point.

2. A stent for supporting a blood vessel, comprising:
a continuous loop of material bent into a plurality of clockwise and counterclockwise arcuate sections each having an adjacent cusp at which the material reverses directions, said material not crossing itself at any point;
said arcuate sections forming a coil with a longitudinal axis about which said arcuate sections are circumferentially disposed;
said cusps of said clockwise and counterclockwise arcuate sections overlapping to form at least one region of overlap; and said region of overlap extending helically about the longitudinal axis.

3. (Amended) A method for forming the stent of claim 2, comprising the steps of:providing a sheet of material from which the stent is to be formed;
photoetching said sheet so as to form a continuous loop;
rolling said continuous loop obliquely between a series of rollers so as to form said continuous loop into a cylindrical stent; and removing said cylindrical stent from said rollers.

4. A double-helix stent, comprising:
a single length of material having first and second ends and forming first and second halves, each half comprising a series of arcuate sections, each section comprising a pair of curved turns, adjacent turns being joined by cusps, said material reversing direction at each cusp and never crossing over itself, said halves being constructed so that the cusps of said first half intermesh with the cusps of said second half, thereby forming two diametrically opposed regions of overlap, each region of overlap being shifted incrementally circumferentially with each turn so that the two regions of overlap describe a double helix around the stent.

5. The stent according to claim 4 wherein said first and second ends of said material are joined so as to form a continuous loop.

Kindly cancel claim 6.

7. A bifurcated stent for supporting a bifurcated vessel without obstructing fluid flow therethrough, comprising:
a major coil consisting essentially of the stent of claim 1; and two minor coils affixed to and integral with one end of the major coil;
said major and minor coils being constructed from a single piece of wire that does not cross itself.

8. The stent according to claim 7 wherein said major coil and said minor coils are all formed from a single continuous loop.

9. A stent for supporting a blood vessel, comprising:
a continuous loop of material wound into a cylindrical double spiral.

10. The stent according to claim 9 wherein said continuous loop includes a pair of ends and a pair of legs extending between said ends, said legs being serpentine.