.
`
`United States Patent [191
`Cragg
`
`US005405377A
`
`[11] Patent Number:
`[45] Date of Patent:
`
`5,405,377
`Apr. 11, 1995
`
`[54] [NTRALUMINAL STENT
`[75] Inventor; Andrew H, Cragg, Bloomington,
`
`5,057,092 10/1991 Webster, Jr. ...................... .. 604/282
`5,067,957 11/1991 Jervis ......... ..
`606/ 108
`
`Min
`
`5,078,736 1/1992 B6111 . . . . .
`
`. . . . . . .. 623/1
`
`[56]
`
`
`Assignee: EndoTech Ltd.’ Guernsey’ Islands
`[21] Appl. No‘: 839,911
`[22] Filed:
`Feb. 21, 1992
`[51] Int. (:1.6 .............................................. .. A61F 2/06
`[52] US. Cl. .... ..
`.. 623/1; 623/12;
`606/191; 606/194; 606/198
`[58] Field of Search .............. .. 604/281; 606/108, 191,
`606/192, 194, 198; 623/1, 12; 139/387 R;
`_
`140/ 11
`References C‘ted
`U-S- PATENT DOCUMENTS
`3,868,956 3/1975 Al?di et a1. ....................... .. 128/345
`3,890,977 6/1975 Wilson ....... ..
`128/418
`3,996,938 12/1976 Clark, 111
`128/348
`4’149’911 4/1979 clabbum
`148/11'5
`4306513 12/1931 Mano et a1
`_______ __ 3/1_4
`4,425,908 1/1984 Simon .... ..
`128/1
`4,503,569 12/ 1985 Dotter .... ..
`623/1
`4,512,338 4/1985 Balko et al
`...... .. 128/1
`4,553,545 11/1985 Maass etal
`128/341
`4,560,374 12/1985 Hammerslag
`.... .. 604/49
`4,580,568 4/1936 Gifmturco
`128/ 345
`128/344
`4949322 3/1987 wlkwr ------- -
`------
`;
`1117:1516“
`4,665,918 5/1987 Garza et al
`128/343
`4,681,110 7/1987 Wiktor ........... ..
`128/343
`4,729,766 3/1988 Bergentz et a1.
`...... .. 623/1
`4,732,152 3/1988 Wallsten et a1.
`128/343
`
`,
`
`,
`
`e s . . . . . . . . . . .
`
`. . . . ..
`
`Wiktor ..... 5,135,536 8/1992 Hillstead ..
`
`....
`606/195
`5,282,824 2/ 1994 Gianturco ......................... .. 606/ 198
`
`FOREIGN PATENT DOCUMENTS
`0145166 6/1985 Eumpean Pat- Off- ~
`wogiggégg
`3,11%! Kingdom -
`‘
`W°92°°°43 V1992 WIPO '
`OTHER PUBLICATIONS
`c. Dotter, R. Buschmann, M. McKinney and J. Rosch,
`“Transluminal Expandable Nitinol Coil Stent Grafting:
`Prehmmary Report,” 147 Radiology at 259760 (APY
`1983)
`“
`”
`L- Schetky, Shape-MéHJOfY Alloys, PP- 74-82
`K. Otsuka and K. Shumzu, “Shape-Memory Alloys-P
`seudoelasticity,” Metals Forum, vol. 4, No. 3, at 142-52
`(1981).
`Cragg, Andrew et al., “Nonsurgical Placement of Arte
`rial Endoprostheses: A New Technique Using Nitinol
`Wire,” Radiology, vol 147, No. 1, pp. 261-263 (Apr.
`1983).
`Cragg, Andrew H. et a1., “Percutaneous Arterial Graft
`ing,” Radiology, V01. 150, N0. 1, pp. 4549 (Jan. 1984).
`Duerig, T. W. et al., “An Engineer’s Perspective of
`ggflgégiaggclty’ The Mechamsm of Pseudaelasmty’
`.
`.
`Pr‘ma'i" Ex‘1m‘”e’—~ler°me,L~ Km“
`Attorney, Agent, or F1rm——T11ton, Fallon, Lungmus &
`
`-
`
`-
`
`a,
`
`-
`
`-
`
`-
`
`4,733,665 3/1988 Palmaz . . . . . . . . .
`
`. . . . .. 604/96
`
`Chestnut
`
`128/343
`4,739,762 4/ 1988 Palmaz
`:3: 1534333
`1:323:83? 311323 812221112511:
`128/343
`4,776,337 10/1988 Palmaz ....... ..
`128/343
`4,800,882 V1989 Gianmrco
`______ N 623/1
`4,320,298 4/1939 Leveen et a1_
`123/343
`4,330,003 5/19g9 Wolff et a1. __
`4,856,516 8/1989 HilStead ............... .. 604/96
`4,878,906 11/1989 Lindemann et al.
`...... .. 623/1
`4,886,062 12/ 1989 Wiktor ........... ..
`128/343
`4,913,141 4/1990 Hillstead ..
`606/108
`4,922,905 5/1990 Strecker
`606/195
`4,969,458 11/ 1990 Wiktor
`606/ 194
`5,019,090 5/1991 Pinchuk
`606/194
`5,041,126 8/1991 Gianturco ......................... .. 606/ 195
`
`ABSTRACT
`[57]
`helbs of
`4.9 919119 ' a1 stem 919111995 4
`zlg'zag We and 1°°P§ wh‘ch °°¥me°t adlacem aplces
`of the wire. The stent 1s compresslble and self-expanda
`ble substantially to a pre-compressed con?guration. A
`method of forming the stent includes bending a length
`Of Wire into a Zig-Zag Con?guration and a helix and
`connecting adjacent apices of the wire- A method im
`planting this stent includes compressing the stent radi
`ally, implanting it in apredetermined location of abody
`vessel, and allowing it to recoil to the con?guration it
`had before compression,
`
`6 Claims, 3 Drawing Sheets
`
`x
`
`W.L. Gore & Associates, Inc.
`Exhibit 1031-1
`
`

`

`
`
`W.L. Gore & Associates, Inc.
`Exhibit 1031-2
`
`

`

`US. Patent
`
`Apr. 11, 1995
`
`Sheet 2 of 3
`
`5,405,377
`
`____ _=
`
`Q N1
`
`W.L. Gore & Associates, Inc.
`Exhibit 1031-3
`
`

`

`US. Patent
`
`Apr. 11, 1995
`
`Sheet 3 of 3
`
`5,405,377
`
`U
`
`FIG. IO
`
`A ii é \l4
`
`(
`
`W.L. Gore & Associates, Inc.
`Exhibit 1031-4
`
`

`

`1
`
`INTRALUMINAL STENT
`
`5,405,377
`2
`graft is a ?exible, tubular shell which allows the wire
`helix to contract and recoil.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`For a more complete understanding of this invention
`one should now refer to the embodiments illustrated in
`greater detail in the accompanying drawings and de
`scribed below by way of examples of the invention. In
`the drawings:
`FIG. 1 is a perspective view of the intraluminal stent
`of the present invention;
`FIGS. 2-4 are side elevation views of a suture con
`nection for the stent of FIG. 1;
`FIG. 5 is a sectional view of the devices used to im
`plant the stent of FIG. 1;
`FIG. 6 is a sectional view of the sheath and catheter
`devices used to implant the stent, showing the catheter
`holding the stent in place as the sheath moves out of the
`body vessel.
`FIG. 7 is a side elevation view of an alternative em
`bodiment of the stent of the present invention;
`FIG. 8 is a sectional view taken along the line 8-8 in
`FIG. 7;
`FIG. 9 is a partial perspective view of the stent of
`FIG. 7, showing a suture connection for the stent; and
`FIG. 10 is a perspective view of the mandrel used to
`form the wire helix of the present invention.
`While the applicant will describe the invention in
`connection with preferred and alternative embodi
`ments, one should understand that the invention is not
`limited to those embodiments. Furthermore, one should
`understand that the drawings are not necessarily to
`scale. In certain instances, the applicant may have omit
`ted details which are not necessary for an understanding
`of the present invention.
`
`15
`
`20
`
`25
`
`30
`
`35
`
`BACKGROUND OF THE INVENTION
`1. Field Of The Invention
`The present invention generally relates to a vascular
`prosthesis, and more particularly to an intraluminal
`stent which has a ?exible and elastic tubular construc
`tion with suf?cient hoop strength to prevent elastic
`recoil of balloon-resistant strictures or to produce de
`layed dilation of those strictures.
`2. Description Of The Prior Art
`The prior art includes a wide variety of intraluminal
`stents and grafts. For example, Palmaz US. Pat. No.
`4,733,665 discloses a balloon-expandable intraluminal
`graft, including an embodiment comprising a wire mesh
`tube. Intersecting wire members, secured to one an
`other at their intersections by welding, soldering or
`gluing, form the wire mesh and de?ne a diamond-like
`pattern. This structure provides a relatively high resis
`tance to radial collapse; but it suffers a number of disad
`vantages. First it is a rigid structure which cannot easily
`assume the con?guration of a curved vessel which re
`ceives it. Second one must use a balloon catheter to
`expand and implant it. This requirement limits the
`length of the graft, as does the rigidity.
`Other prior stents have more ?exible constructions;
`but they suffer other disadvantages. Wiktor US. Pat.
`No. 4,886,062, for example, discloses a stent which has
`a relatively ?exible construction. This construction
`includes a deformable wire bent into a zig-zag design
`and coiled in a spiral fashion. The resulting wire tube
`has an open con?guration with a reduced hoop
`strength. Each hoop lies essentially isolated from the
`adjacent hoops and does not obtain substantial support
`from them. Moreover, the open con?guration increases
`the risk that plaque elements may herniate through the
`coil. Finally, one must use a balloon catheter to expand
`and implant it. Thus, the length of the stent cannot
`exceed the balloon length of available balloon catheters.
`The intraluminal stent of the present invention avoids
`the disadvantages of the prior art stents and grafts. It
`has suf?cient hoop strength to prevent elastic recoil of
`balloon-resistant strictures. The stent of the present
`invention has a ?exible construction which allows it to
`follow the curvature of the vessel which receives it. It
`has an elastic construction which allows implantation
`without a balloon catheter. This elasticity further al
`lows compression of the structure and recoil upon im
`plantation to produce delayed dilation of the receiving
`vessel.
`
`40
`
`45
`
`50
`
`DETAILED DESCRIPTION OF THE
`DRAWINGS
`Turning now to the drawings, FIG. 1 shows the
`intraluminal stent of the present invention generally at
`10. This stent includes a wire body 11 made out of a
`predetermined length of wire having a sinuous or zig
`zag con?guration and defining a continuous helix with
`a series of connected spirals or hoops. It also includes
`loop members 12 which connect adjacent apices of
`adjacent helix hoops to help de?ne the tubular stent.
`The loop members 12 may connect all or some of the
`pairs of adjacent apices.
`The wire body 11 is an elastic alloy which provides
`radial elasticity for the stent. Preferably, it is a nitinol
`alloy which has superior elasticity and fatigue resis
`tance. The wire has a round cross-section; but its cross
`section may also be any one of a variety of shapes, e.g.,
`triangular, rectangular, etc. Alternatively, any material
`of suf?cient strength and. elasticity and the other prop
`erties identi?ed above may form the wire body, includ
`ing stainless steel, tantalum, titanium, or any one of a
`variety of plastics.
`The loop members 12 connect adjacent apices of
`adjacent hoops of the wire body 11 so that the adjacent
`apices abut each other (See FIGS. 2-4). Thus, each
`hoop receives support from adjacent hoops, increasing
`the hoop strength of the overall stent, structure and
`minimizing the risk of plaque herniation. The loop
`members 12 are ligatures of suture material with the
`ends tied together to form a loop. This material is poly
`propylene material or any other biocompatible material
`
`55
`
`SUMMARY OF THE INVENTION
`In accordance with an embodiment of the present
`invention, an intraluminal stent includes a predeter~
`mined length of wire having a sinuous or zig-zag con?g
`uration and de?ning a continuous helix with a plurality
`of connected spirals or hoops. A plurality of loop mem
`bers connect adjacent apices of adjacent helix hoops.
`The stent is compressible and self-expandable substan
`tially to the con?guration prior to compression.
`In accordance with an alternative embodiment of the
`present invention, an intraluminal stent includes the
`continuous helix and the plurality of loop members
`described above. It also includes a prosthetic graft dis
`65
`posed longitudinally of the wire helix within its central
`opening (or around the wire helix). One or more of the
`loop members secures the graft to the wire helix. This
`
`60
`
`W.L. Gore & Associates, Inc.
`Exhibit 1031-5
`
`

`

`10
`
`20
`
`25
`
`30
`
`35
`
`5,405,377
`3
`4
`of suf?cient strength. Although sutures are the pre
`hold the stent at the location with the catheter, and then
`ferred connecting means, other connecting means such
`removing the sheath. The ?nal step involves removal of
`as staples and rings made of metal or plastic may pro
`the catheter to allow the stent to recoil.
`In applications in which the wire body is a nitinol
`vide the same function.
`The stent structure of the present invention allows
`metal, a user reduces the diameter of the stent by ?rst
`compression prior to implantation in a human or animal
`cooling it, e.g., by submerging it in ice water. This
`vessel. After implantation, upon release of the compres
`cooling places the nitinol in a martensitic phase and
`sive force, the stent structure recoils (or self-expands) to
`facilitates manual reduction of‘the diameter and inser
`its original con?guration. Thus, it continues to provide
`tion of the stent in the central bore of the device 16. The
`dilating force in the implanted state. The structure pro
`device 16 and the sheath 18 restrain the stent until de
`vides ?exibility which allows the stent to follow the
`ployment in a predetermined location. At that location
`curvature of the vessel which receives it.
`in a subject’s body, body ?uids warm the nitinol and
`place it in an austenitic phase which is the stable phase
`Turning now to FIGS. 7-9, an alternative embodi
`ment of the present invention includes the wire body
`of this metal and which corresponds to a fully opened
`or expanded con?guration of the stent (to its original
`and suture connections described above. This alterna
`tive also includes a prosthetic graft 13 disposed inside
`annealed diameter).
`the central opening of the wire body. The graft 13 is a
`While the above description and the drawings illus
`round, open tube made of polytetra?uoroethylene
`trate one embodiment and an alternative, one should
`(PTFE), dacron or any other suitable biocompatible
`understand, of course, that the invention is not limited
`material. It has an outside diameter slightly smaller than
`to those embodiments. Those skilled in the art to which
`the inside diameter of the wire body 11. One or more
`the invention pertains may make other modi?cations
`hoop members connect the graft 13 to the wire body 11
`and other embodiments employing the principals of this
`invention, particularly upon considering the foregoing
`as shown in FIG. 9. In place, the graft closes the
`diamond shaped openings of the stent structure to fur
`teachings. For example, one may use a deformable ma
`ther minimize plaque herniation and minimize the flow
`terial to construct the wire body 11 of the stent and then
`of ?uid and cellular elements through the structure.
`use a balloon catheter to deploy it. The applicant, there
`Alternatively, the graft 13 may lie around the outside
`fore, by the appended claims, intends to cover any mod
`of the wire helix. Furthermore, the graft 13 may be
`i?cations and other embodiments which incorporate
`co-extensive with the wire helix; or it may be shorter
`those features which constitute the essential features of
`than the wire helix. Finally, the graft 13 may include a
`this invention.
`plurality of segments disposed within the wire helix or
`What is claimed is:
`around the outside of the helix.
`1. An intraluminal stent comprising: a predetermined
`The method of making the stent of the present inven
`length of elastic wire having a zig-zag con?guration and
`tion includes bending a predetermined length of wire in
`de?ning a continuous helix with a plurality of hoops; a
`plurality of loop members for connecting adjacent api
`a zig-zag fashion between the pins 14 of the mandrel 15
`and around the mandrel, thus forming a helix (See FIG.
`ces of adjacent helix hoops; the loop members and the
`10). The next step includes removing the helix from the
`wire being separate members and made of different
`mandrel by removing the pins and sliding the helix off
`materials, the stent being compressible and self-expand
`the mandrel. The process further includes connecting
`able substantially to a pre-compressed con?guration.
`adjacent apices of adjacent helix hoops. A fabricator
`2. The stent of claim 1, wherein the loop members
`makes each connection by placing a ligature of suture
`connect the adjacent apices of the helix hoops in abut
`ting relation.
`material (or any other suitable material) around the wire
`segments which de?ne two adjacent apices and tying
`3. The stent of claim 1, wherein the elastic wire is a
`high shape memory nitinol alloy.
`the ends of the ligature together to form a loop. In
`applications in which the wire body is nitinol wire, the
`4. The stent of claim 1, wherein the loop members
`process includes securing the ends of the wire to the
`have a substantially greater ?exibility than the wire.
`mandrel and annealing the wire to a predetermined
`5. An intraluminal stent comprising: a predetermined
`temperature (and thus imparting a thermal memory for
`length of elastic wire having a zig-zag con?guration and
`the annealed shape) before removing the helix from the
`de?ning a continuous helix with a plurality of hoops; a
`plurality of loop members for connecting adjacent api
`mandrel.
`The method of implanting the stent of the present
`ces of adjacent helix hoops, each said loop member
`invention includes compressing it and placing it into the
`including a single ligature of suture material tied into a
`loop; the stent being compressible and self-expandable
`central bore of an introducing device 16. The next step
`includes coupling the device 16 with the hub 17 of a
`substantially to a pre-compressed con?guration.
`sheath 18 which extends to the implantation location.
`6. The stent of claim 5, wherein the suture material is
`The next step involves using a catheter 19 to push the
`made of polypropylene.
`compressed stent to the predetermined location and to
`* *
`
`40
`
`50
`
`65
`
`*
`
`W.L. Gore & Associates, Inc.
`Exhibit 1031-6
`
`