United States Patent [191
`Palmaz
`
`[11]
`[45]
`
`Patent Number:
`Date of Patent:
`
`4,733,665
`Mar. 29, 1988
`
`[54]
`
`[75]
`[73]
`
`[21]
`[22]
`[51]
`[52]
`[58]
`
`[56]
`
`EXPANDABLE INTRALUMINAL GRAFI‘,
`AND METHOD AND APPARATUS FOR
`IMPLANTING AN EXPANDABLE
`INTRALUMINAL GRAFT
`Inventor:
`Julio C. Palrnaz, San Antonio, Tex.‘
`Assignee: Expandable Grafts Partnership, San
`Antonio, Tex.
`Appl. No.: 796,009
`Filed:
`' Nov. 7, 1985
`
`Int. Cl.‘ ........................................... .. A61M 29/00
`US. Cl. .................................. .. 128/343; 604/104;
`604/96; 623/1
`Field of Search .............................. .. 128/343-344,
`128/1 R; 623/1; 604/96, 104, 106-109
`References Cited
`U.S. PATENT DOCUMENTS
`
`2,701,559 2/1955 Cooper .............................. .. 128/344
`3,774,596 11/ 1973 Cook .
`3,868,956 3/1975 Al?di et al. .
`3,882,845 5/1975 Buealo .............................. .. 128/1 R
`3,889,685 6/1975 Miller et a1.
`128/348
`4,018,230 4/ 1977 Ochiai et a1.
`.. 128/ 344
`4,140,126 2/ 1979 Choudhury .
`4,141,364 2/ 1979 Schultze .
`4,183,102 1/ 1980 Guiset .................................... .. 3/ 1.4
`4,299,226 11/1981 Banka .
`4,318,410 3/1982 Chin .
`4,416,028 11/1983 Erikson et al. .
`4,425,908 l/ 1984 Simon .
`4,483,339 ll/ 1984 Gillis .
`4,483,340 11/ 1984 Fogarty et a1. ................... .. 128/344
`4,503,569 3/1985 Dotter .................................... .. 3/ 1.4
`4,512,338 4/1985 Balko .
`4,553,545 1l/1985 Maass .
`4,560,374 12/ 1985 Hammerslag .
`4,562,596 l/ 1986 Kornberg .
`4,564,014 171986 Fogerty et a1. .
`4,577,631 3/1986 Kreamer .
`
`4,580,568 4/ 1986 Gianturco .
`4,650,466 3/ 1987 Luther ............................... .. 604/266
`FOREIGN PATENT DOCUMENTS
`0183372 4/1986 European Pat. Off. .
`2135585 9/1984 United Kingdom.
`
`OTHER PUBLICATIONS
`“Flexible Balloon-Expanded Stent for Small Vessels”,
`Radiology, Jan. 1987, pp. 276-280, vol. 162, No. 1.
`“Expandable Intraluminal Graft: A Preliminary
`Study”; Radiology Jul. 1985; paper presented at 70th
`Scienti?c Assembly and Annual Meeting of the Radio
`logical Society of North America, Nov. 25, 1984, by
`Julio C. Palmaz et al.
`“Percutaneous Endovascular Stents: An Experimental
`Evaluation”; Wright et al., Radiology 156; 1985.
`“Transluminal Expandable Nitinol Coil Stent Grafting:
`Preliminary Report” Dotter et al.; Radiology 147; 1983.
`“Non Surgical Placement of Arterial Endoprostheses:
`A New Technique Using Nitinol Wire”; Cragg et al.;
`Radiology 147, 1983.
`“Transluminally-Placed Coilspring Endurtorial Tube
`Grafts”; Dotter Investigative Radiology; Sep.—Oct.
`1969.
`“Radio Logical Follow-Up of Transluminally Inserted
`Vascular Endoprostheses: An Experimental Study
`Using Expanding Spirals”; Radiology 152; 1984.
`Primary Examiner—C. Fred Rosenbaum
`Assistant Examiner-Gene B. Kartchner
`Attorney, Agent, or Firm-—Ben D. Tobor
`[57]
`ABSTRACT
`An expandable intraluminal vascular graft is expanded
`within a blood vessel by an angioplasty balloon associ
`ated with a catheter to dilate and expand the lumen of a
`blood vessel. The graft may be a wire mesh tube.
`
`28 Claims, 6 Drawing Figures
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1008 - Page 1
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`

`

`US. Patent Mar. 29, 1988
`
`Sheet 1 of2
`
`4,733,665
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1008 - Page 2
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`

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`US. Patent Mar. 29, 1988
`
`Sheet 2 of2
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`4,733,665
`
`Pier-3
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`IIIIIIIIIIIIIIIIIIIIIIJ
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`Fig-4'
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1008 - Page 3
`
`

`

`1
`
`EXPANDABLE INTRALUMINAL GRAFT, AND
`METHOD AND APPARATUS FOR IMPLANTING
`AN EXPANDABLE INTRALUMINAL GRAFT
`
`Field of the Invention
`The government of the United States of America
`retains a non-exclusive, irrevocable, royalty-free license
`in this invention for all governmental purposes, pursu
`ant to 37 CPR. §l00.6(b) (2).
`The invention relates to an expandable intraluminal
`graft for use within a body passageway or duct and,
`more particularly, expandable intraluminal vascular
`grafts which are particularly useful for repairing ‘blood
`vessels narrowed or occluded by disease; and a method
`and apparatus for implanting expandable intraluminal
`grafts.
`
`5
`
`4,733,665
`2
`mounted angioplasty balloon. In this procedure, the
`angioplasty balloon is inflated within the stenosed ves
`sel, or body passageway, in order to shear and disrupt
`the wall components of the vessel to obtain an enlarged
`lumen. With respect to arterial atheroscleerotic lesions,
`the relatively incompressible plaque remains unaltered,
`while the more elastic medial and adventitial layers of
`the body passageway stretch around the plaque. This
`process produces dissection, or a splitting and tearing,
`of the body passageway wall layers, wherein the intima,
`or internal surface of the artery or body passageway,
`suffers ?ssuring. This dissection forms a “flap” of un
`derlying tissue which may reduce the blood ?ow
`through the lumen, or block the lumen. Typically, the
`distending intraluminal pressure within the body pas
`sageway can hold the disrupted layer, or flap, in place.
`If the intimal ?ap created by the balloon dilation proce
`dure is not maintained in place against the expanded
`intima, the intimal ?ap can fold down into the lumen
`and close off the lumen, or may even become detached
`and enter the body passageway. When the intimal ?ap
`closes off the body passageway, immediate surgery is
`necessary to correct this problem.
`Although the balloon dilation procedure is typically
`conducted in the catheterization lab of a hospital, be
`cause of the foregoing problem, it is always necessary to
`have a surgeon on call should the intimal ?ap block the
`blood vessel or body passageway. Further, because of
`the possibility of the intimal ?ap tearing away from the
`blood vessel and blocking the lumen, balloon dilations
`cannot be performed upon certain critical body passage
`ways, such as the left main coronary artery, which leads
`into the heart. If an intimal ?ap formed by a balloon
`dilation procedure abruptly comes down and closes off
`a critical body passageway, such as the left main coro
`nary artery, the patient could die before any surgical
`procedures could be performed.
`.
`Additional disadvantages associated with balloon
`dilation of elastic vascular stenoses is that many fail
`because of elastic recoil of the stenotic lesion. This
`usually occurs due to a high ?brocollagenous content in
`the lesion and is sometimes due to certain mechanical
`characteristics of the area to be dilated. Thus, although
`the body passageway may initially be successfully ex
`panded by a balloon dilation procedure, subsequent,
`early restenosis can occur due to the recoil of the body
`passageway wall which decreases the size of the previ
`ously expanded lumen of the body passageway. For
`example, stenoses of the renal artery at the ostium are
`known to be refractory to balloon dilation because the
`dilating forces are applied to the aortic wall rather than
`to the renal artery itself. Vascular stenoses caused by
`neointimal ?brosis, such as those seen in dialysis-access
`fistulas, have proved to be difficult to dilate, requiring
`high dilating pressures and larger balloon diameters.
`Similar difficulties have been observed in angioplasties
`of graft-artery anastomotic strictures and postendar
`terectomy recurrent stenoses. Percutaneous angioplasty
`of Takayasu arteritis and neuro?bromatosis arterial
`stenoses may show poor initial response and recurrence
`which is believed due to the ?brotic nature of these
`lesions.
`Accordingly, prior to the development of the present
`invention, there has been no expandable intraluminal
`vascular graft, and method and apparatus for expanding
`the lumen of a body passageway, which: prevents re
`currence of stenoses in the body passageway; can be
`
`60
`
`Description of the Prior Art
`Intraluminal endovascular grafting has been demon
`strated by experimentation to present a possible alterna
`tive to conventional vascular surgery. Intraluminal en
`dovascular grafting involves the percutaneous insertion
`into a blood vessel of a tubular prosthetic graft and its
`delivery via a catheter to the desired location within the
`vascular system. Advantages of this method over con
`ventional vascular surgery include obviating the need
`for surgically exposing, incising, removing, replacing,
`or bypassing the defective blood vessel.
`Structures which have previously been used as intra
`luminal vascular grafts have included coiled stainless
`steel springs; helically wound coil springs manufactured
`from an expandable heat~sensitive material; and expand
`ing stainless steel stents formed of stainless steel wire in
`a zig-zag pattern. In general, the foregoing structures
`have one major disadvantage in common. Insofar as
`these structures must be delivered to the desired loca
`tion within a given body passageway in a collapsed
`state, in order to pass through the body passageway,
`there is no effective control over the ?nal, expanded
`con?guration of each structure. For example, the ex
`panison of a particular coiled spring-type graft is prede
`termined by the spring constant and modulus of elastic
`ity of the particular material utilized to manufacture the
`coiled spring structure. These same factors predeter
`mine the amount of expansion of collapsed stents
`formed of stainless steel wire in a zig-zag pattern. In the
`case of intraluminal grafts, or prostheses, formed of a
`heat sensitive material which expands upon heating, the
`amount of expansion is likewise predetermined by the
`heat expansion characteristics of the particular alloy
`utilized in the manufacture of the intraluminal graft.
`Thus, once the foregoing types of intraluminal grafts
`are expanded at the desired location within a body pas
`sageway, such as within an artery or vein, the expanded
`55
`size of the graft cannot be changed. If the diameter of
`the desired body passageway has been miscalculated, an
`undesized graft might not expand enough to contact the
`interior surface of the body passageway, so as to be
`secured thereto. It may then migrate away from the
`desired location within the body passageway. Likewise,
`an oversized graft might expand to such an extent that
`the spring force, or expansion force, exerted by the graft
`upon the body passageway could cause rupturing of the
`body passageway.
`Another alternative to conventional vascular surgery
`has been percutaneous balloon dilation of elastic vascu
`lar stenoses, or blockages, through use of a catheter
`
`35
`
`45
`
`65
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1008 - Page 4
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`

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`4,733,665
`3
`4
`the body passageway. A further. feature of the present
`utilized for critical body passageways, such as the left
`main coronary artery of a patient’s heart; prevents re
`invention is that a catheter having an expandable, in?at
`coil of the body passageway wall; and allows the intra
`able portion associated therewith may be utilized; and
`expansion of the intraluminal graft and the portion of
`luminal graft to be expanded to a variable size to pre
`vent migration of the graft away from the desired loca
`the catheter is accomplished by in?ating the expand
`tion; and to prevent rupturing of the body passageway
`able, in?atable portion of the catheter.
`by the expanded graft. Therefore, the art has sought an
`A further feature of the present invention is that a
`expandable intraluminal vascular graft, and method and
`wire mesh tube may be utilized as the intraluminal graft,
`apparatus for expanding the lumen of a body passage
`the wire mesh tube having a ?rst predetermined, col
`way which: prevents recurrence of stenoses in the body
`lapsed diameter which permits the tube to be inserted
`passageway; is believed to be able to be utilized in criti
`within the body passageway at and delivered to the
`cal body passageways, such as the left main coronary
`desired location. Another feature of the present inven
`artery of the heart; prevents recoil of the body passage
`tion is that the wire mesh tube may be expanded to a
`way; and can be expanded to a variable size within the
`second diameter within the body passageway; the sec
`body passageway to prevent migration of the graft
`ond, expanded diameter being variable and determined
`away from the desired location; and to prevent ruptur
`by the desired expanded internal diameter of the body
`ing of the body passageway by the expanded graft.
`passageway, whereby the expanded wire mesh tube will
`not migrate from the desired location within the body
`SUMMARY OF THE INVENTION
`passageway and the expansion of the intraluminal graft
`In accordance with the invention the foregoing ad
`does not cause a rupture of the body passageway.
`vantages have been achieved through the present ex
`In accordance with the invention, the foregoing ad
`pandable intraluminal vascular graft. The present inven
`vantages have also been achieved through the present
`tion includes a tubular shaped member having ?rst and
`apparatus for intraluminally reinforcing a body passage
`second ends and a wall surface disposed between the
`way. The present invention includes: an expandable,
`?rst and second ends, the wall surface being formed by
`tubular shaped prosthesis having ?rst and second ends
`a plurality of intersecting elongate members, at least
`and a wall surface disposed between the ?rst and second
`some of the elongate members intersecting with one
`ends, the wall surface being formed by a plurality of
`another intermediate the ?rst and second ends of the
`intersecting elongate members; and a catheter, having
`,-,:;tubular shaped member; the tubular shaped member
`an expandable, in?atable portion associated therewith
`;;having a ?rst diameter which permits intraluminal de
`and including means for mounting and retaining the
`?livery of the tubular shaped member into a body pas
`expandable tubular shaped prosthesis on the expand
`sageway having a lumen; and the tubular shaped mem
`able, in?atable portion, whereby upon in?ation of the
`ber having a second, expanded diameter, upon the ap
`expandable, in?atable portion of the catheter, the pros
`plication fromthe interior of the tubular shaped mem
`thesis is forced radially into contact with the body pas
`ber of a radially, outwardly extending force, which
`sageway. A further feature of the present invention is
`second diameter is variable and dependent upon the
`that the mounting and retaining means may comprise a
`amount of force applied to the tubular shaped member,
`retainer ring member disposed on the catheter adjacent
`whereby the tubular shaped member may be expanded
`the expandable, in?atable portion and adjacent each end
`;. to expand the lumen of the body passageway.
`of the expandable, tubular shaped prosthesis.
`41': A further feature of the present invention is that the
`40
`The expandable intraluminal vascular graft, method
`v.vagplurality of elongate members may be a plurality of
`for expanding the lumen of a body passageway, and
`':i?{Wi1'CS, and the wires may be ?xedly secured to one
`apparatus for intraluminally reinforcing a body passage
`' another where the wires intersect with one another. An
`way of the present invention, when compared with
`additional feature of the present invention is that the
`previously proposed prior art intraluminal grafts, meth
`plurality of elongate members may be a plurality of thin
`ods for implanting them, and balloon dilation tech
`bars which are ?xedly secured to one another where the
`niques have the advantages of: preventing recurrence of
`bars intersect with one another. A further feature of the
`stenoses; is believed to permit implantation of grafts in
`present invention is that the tubular shaped member
`critical body passageways, such as in the left main coro
`may have a biologically inert coating on its wall surface,
`nary artery of the heart; prevents recoil of the body
`and the coating may include a means for anchoring the
`passageway; and permits expansion of the graft to a
`tubular shaped member to the body passageway.
`variable size dependent upon conditions within the
`In accordance with the invention, the foregoing ad
`body passageway.
`vantages have also been achieved through the present
`method for expanding the lumen of a body passageway.
`The method of the present invention comprises the
`steps of: inserting an intraluminal graft, disposed upon a
`catheter, into the body passageway until it is disposed
`adjacent a desired location within the body passageway;
`and expanding a portion of the catheter to cause the
`intraluminal graft to radially expand outwardly into
`contact with the body passageway until the lumen of
`the body passageway at the desired location of the body
`passageway has been expanded, whereby the intralu
`minal graft prevents the body passageway from collaps
`ing and decreasing the size of the expanded lumen.
`A further feature of the present invention is that the
`portion of the catheter in contact with the intraluminal
`graft may be collapsed, and the catheter removed from
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`In the drawings:
`FIG. 1A is a perspective view of an expandable intra
`luminal vascular graft, or prosthesis for a body passage
`way, having a ?rst diameter which permits delivery of
`the graft, or prosthesis, into a body passageway;
`FIG. 1B is a perspective view of the graft, or prosthe
`sis, of FIG. 1A, in its expanded con?guration when
`disposed within a body passageway;
`FIG. 2A is. a perspective view of another embodi
`ment of an expandable intraluminal vascular graft, or
`prosthesis for a body passageway, having a ?rst diame
`ter which permits intraluminal delivery of the graft, or
`prosthesis, into a body passageway; '
`
`60
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`4,733,665
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`FIG. 2B is a perspective view of the graft, or prosthe
`diameter, d, which, to be hereinafter described in
`greater detail, permits intraluminal delivery of the tubu
`sis, of FIG. 2A, shown in its expanded con?guration
`when disposed within a body passageway;
`lar shaped member 71 into a body passageway 80 hav
`ing a lumen (FIG. 3). With reference to FIG. 1B, upon
`FIG. 3 is a cross-sectional view of an apparatus for
`the application from the interior of the tubular shaped
`intraluminally reinforcing a body passageway, or for
`expanding the lumen of a body passageway, illustrating
`member ‘71 of a radially, outwardly extending force, to
`be hereinafter described in greater detail, tubular
`a prosthesis, or intraluminal vvascular graft, in the con
`?gurations shown in FIGS. 1A and 2A;
`shaped member 71 has a second, expanded diameter, d’,
`which second diameter d’ is variable in size and depen
`FIG. 4 is a cross-sectional view of the apparatus for
`intraluminally reinforcing a body passageway, or for
`dent upon the amount of force applied to the tubular
`shaped member 71.
`expanding the lumen of a body passageway, with a
`graft, or prosthesis, in the con?gurations shown in
`With reference to FIGS. 1A and 1B, elongate mem
`bers 75, 76, which form wall surface 74 of tubular
`FIGS. 1B and 2B.
`shaped member 71, may be any suitable material which
`When the invention will be described in connection
`is compatible with the human body and the bodily ?uids
`with the preferred embodiment, it will be understood
`(not shown) with which the vascular graft, or prosthe
`that it is not intended to limit the invention to that em
`bodiment. 0n the contrary, it is intended to cover all
`sis, 70 may come into contact. Elongate members 75, 76 ‘
`must also be made of a material which has the requisite
`alternatives, modi?cations, and equivalents, as may be
`strength and elasticity characteristics to permit the tu
`included within the spirit and scope of the invention as
`de?ned by the appended claims.
`bular shaped member 71 to be expanded from the con
`?guration shown in FIG. 1A to the con?guration
`DETAILED DESCRIPTION OF THE
`shown illustrated in FIG. 1B and further to permit the
`INVENTION
`tubular shaped member 71 to retain its expanded con?g
`uration with the enlarged diameter d’ shown in FIG.
`In FIGS. 1A and 2A, an expandable intraluminal
`vascular graft, or expandable prosthesis for a body pas
`1B. Suitable materials for the fabrication of tubular
`shaped member 71 would include silver, tantalum, stain
`sageway, 70 is illustrated. It should be understood that
`less steel, gold, titanium or any suitable plastic material
`the terms “expandable intraluminal vascular graf ” and
`having the requisite characteristics previously de
`“expandable prosthesis” are interchangeably used to
`scribed. Preferably, elongate members 75, 76 are fabri
`some extent in describing the present invention, insofar
`cated from stainless steel. Preferably, the elongate mem
`as the methods, apparatus, and structures of the present
`invention may be utilized not only in connection with
`bers 75, 76 illustrated in FIGS. 1A and 1B are small
`an expandable intraluminal vascular graft for expanding
`diameter stainless steel wires having a cylindrical cross
`partially occluded segments of a blood vessel, or body
`section. It should of course be understood that each
`elongate member 75, 76, could have other cross-sec
`passageway, but may also be utilized for many other
`tional con?gurations, such as triangular, square, rectan
`purposes as an expandable prosthesis for many other
`types of body passageways. For example, expandable
`gular, hexagonal, etc. Further, it is preferable that the
`plurality of elongate members 75, 76 are ?xedly secured
`prostheses 70 may also be used for such purposes as: (1)
`supportive graft placement within blocked arteries
`to one another where the elongate members 7 5, 76 inter
`opened by transluminal recanalization, but which are
`sect with one another, such as at the intersection points
`77. Elongate members 75, 76 could be ?xedly secured to
`likely to collapse in the absence of an internal support;
`(2) similar use followingcatheter passage through medi
`one another in any conventional manner, such as by
`astinal and other veins occluded by inoperable cancers;
`welding, soldering, or gluing, such as with a suitable
`epoxy glue; however, it is preferred that the intersection
`(3) reinforcement of catheter created intrahepatic com
`points 77 are soldered with silver. By ?xedly securing
`munications between portal and hepatic veins in pa
`tients suffering from portal hypertension; (4) supportive
`the elongate members 75, 76, to one another, tubular
`graft placement of narrowing of the esophagus, the
`member 71 is provided with a relatively high resistance
`intestine, the ureters, the urethra; and (5) supportive
`to radial collapse, and the tubular shaped member 71
`graft reinforcement of reopened and previously ob
`has the ability to retain its enlarged diameter, d’, as
`shown in FIG. 1B. Preferably, tubular shaped member
`structed bile ducts. Accordingly, use of the term “pros
`thesis” encompasses the foregoing usages within vari
`71 is made of continuous, stainless steel wire woven in a
`ous types of body passageways, and the use of the term
`criss-crossed tubular pattern to form what can be gener
`ally described as a wire mesh tube.
`“intraluminal vascular graf ” encompasses use for ex
`When fabricating tubular shaped member, or wire
`panding the lumen of a body passageway. Further, in
`this regard, the term “body passageway” encompasses
`mesh tube, 71, it can be initially fabricated in the con?g
`any duct within the human body, such as those previ
`uration shown in FIG. 1A with diameter, d. Alterna
`tively, it can be fabricated with a diameter which is
`ously described, as well as any vein, artery, or blood
`vessel within the human vascular system.
`larger than initial diameter d and after fabrication, tubu
`lar shaped member 71 could be carefully collapsed to
`Still with reference to FIG. 1A, the expandable intra
`luminal vascular graft, or prosthesis, 70 is shown to
`have diameter d shown in FIG. 1A. During the collaps
`generally comprise a tubular shaped member 71 having
`ing of tubular shaped member, or wire mesh tube, 71,
`?rst and second ends 72, 73 and a wall surface 74 dis
`care must be taken to insure that overlapping of adja
`posed between the ?rst and second ends 72, 73. Prefera
`cent elongate members 75, 76 is avoided. It should of
`bly, the wall surface 74 is formed by a plurality of inter
`course be understood that upon expansion of tubular
`secting elongate members 75, 76 with at least some of
`shaped member, or wire mesh tube, 71 into the con?gu
`the elongate members 75, 76 intersecting with one an
`ration shown in FIG. 1B, the distance between ?rst and
`65
`other intermediate the ?rst and second ends 72, 73 of the ‘
`second ends 72 and 73 will of course decrease.
`tubular shaped member 71, such as shown at intersec
`With reference now to FIGS. 2A and 2B, another
`embodiment of expandable intraluminal vascular graft,
`tion points 77. Tubular shaped member 71 has a ?rst
`
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1008 - Page 6
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`4,733,665
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`7
`In a conventional manner, the catheter 83 and graft,
`or prosthesis, 70, is illustrated. The same reference nu
`or prosthesis, 70 are delivered to the desired location
`merals are utilized and are applicable for elements pre
`viously described in FIGS. 1A and 1B. The intraluminal
`within the body passageway 80, whereat it is desired to
`expand the lumen 81 of body passageway 80 via intralu
`vascular graft, or prosthesis, 70 of FIGS. 2A and 2B
`differs from that previously described in connection
`minal graft 70, or where it is desired to implant prosthe
`with FIGS. 1A and 1B, in that the plurality of elongate
`sis 70. Fluoroscopy, and/or other conventional tech
`niques may be utilized to insure that the catheter 83 and
`members 75 and 76 are a plurality of thin bars 78, 79
`which are preferably ?xedly secured to one another
`graft, or prosthesis, 70 are delivered to the desired loca
`tion within the body passageway. Prosthesis, or graft,
`where the bars 78, 79 intersect with one another. Bars
`70 are then expanded by expanding the expandable,
`78, 79 preferably have a thin, rectangular cross-sec
`in?atable portion 84 of catheter 83, whereby the pros
`tional con?guration, and may be joined to one another
`thesis, or graft, 70 is forced radially, outwardly into
`in any conventional manner, such as by welding, braz
`ing, soldering, or may be formed integral with one an
`contact with the body passageway 80 as shown, in FIG.
`other. Preferably, tubular shaped member 71 is initially
`4. In this regard, the expandable, in?atable portion of
`a thin-walled stainless steel tube, and the openings 82
`catheter 83 may be a conventional angioplasty balloon
`88. After the desired expansion of prosthesis, or graft,
`between the intersecting bars 78 and 79 are formed by a
`70 has been accomplished, angioplasty balloon 88 may
`conventional etching process, such as electromechani
`cal or laser etching, whereby the resultant structure is a
`be collapsed, or de?ated, and the catheter 83 may be
`tubular shaped member 71 having a plurality of inter
`removed in a conventional manner from body passage
`secting elongate members 78, 79. The embodiment of
`way 80. If desired, as seen in FIG. 3, catheter 83, having
`20
`graft or prosthesis, 70 disposed thereon, may be initially
`graft, or prosthesis, 70 of FIG. 2A, likewise can assume
`an expanded con?guration as shown in FIG. 2B and as
`encased in a conventional Te?on TM sheath 89, which
`previously described in connection with FIG. 1B, upon
`is pulled away from prosthesis, or graft, 70, prior to
`the application from the interior of the tubular shaped
`expansion of the prosthesis, or graft, 70.
`member 71 of a radially, outwardly extending force. It
`Still with reference to FIGS. 3 and 4, it should be
`25
`should be further understood that the embodiment of
`noted that the tubular shaped member 71 of prosthesis,
`vascular graft, or prosthesis, 70 of FIGS. 2A and 2B,
`or graft, 70 initially has the ?rst predetermined, col
`could also be generally described as a wire mesh tube.
`lapsed diameter d as described in connection with
`FIGS. 1A and 2A, in order to permit the insertion of the
`M With reference now to FIGS. 3 and 4, the methods
`“'li'and apparatus of the present invention will be described
`wire mesh tube, or tubular shaped member, 71 into the
`Plin greater detail. Once again, it should be understood
`body passageway 80 as previously described. When it is
`desired to implant prosthesis 70 within a body passage
`- that the methods and apparatus of the present invention
`“are useful not only for expanding the lumen of a body
`way 80 for the purposes previously described, the wire
`mesh tube, or prosthesis 70, is expanded to the second
`passageway, such as an artery, vein, or blood vessel of
`diameter d’ and the second, expanded diameter d’ is
`the human vascular system, but are also useful to per
`form the previously described procedures to intralumi
`variable and determined by the internal diameter of the
`nally reinforce other body passageways or ducts, as
`body passageway 80, as shown in FIG. 4. Accordingly,
`the expanded prosthesis 70, upon de?ation of angio
`-‘ previously described. Still with reference to FIGS. 3
`and 4, an expandable intraluminal vascular graft, or
`plasty balloon 88 will not be able to migrate from the
`.:.:prosthesis, 70, which may be of the type previously
`desired location within the body passageway 80, nor
`will the expansion of the prosthesis 70 be likely to cause
`.radescribed in connection with FIGS. 1A or 2A, is dis
`.a‘aposed or mounted upon a catheter 83. Catheter 83 has
`a rupture of the body passageway 80.
`“an expandable, in?atable portion 84 associated there
`When it is desired to use expandable intraluminal
`with. Catheter 83 includes means for mounting and
`graft 70 to expand the lumen 81 of a body passageway
`retaining 85 the expandable intraluminal vascular graft,
`80 having an area of stenosis, the expansion of intralu
`or prosthesis, 70 on the expandable, inflatable portion 84
`minal vascular graft 70 by angioplasty balloon 88, al
`of catheter 83. Preferably, the mounting and retaining
`lows controlled dilation of the stenotic area and, at the
`means 85 comprises retainer ring members 86 disposed
`same time controlled expansion of the vascular graft 70,
`whereby vascular graft 70 prevents the body passage
`on the catheter 83 adjacent the expandable in?atable
`portion 84 of catheter 83; and a retainer ring member 86
`way 80 from collapsing and decreasing the size of the
`is disposed adjacent each end 72, 73 of the expandable
`previously expanded lumen 81. Once again, the second,
`intraluminal vascular graft, or prosthesis, 70. Prefera
`expanded diameter d’ of intraluminal vascular graft 70,
`bly, as seen in FIG. 3, while retainer ring members are
`as shown in FIG. 4 is variable and determined by the
`formed integral with catheter 83, and the retainer ring
`desired expanded internal diameter of body passageway
`member 86 adjacent the leading tip 87 of catheter 83
`80. Thus, the expandable intraluminal graft 70 will not
`slopes upwardly and away from catheter tip 87 in order
`migrate away from the desired location within the body
`to protect and retain graft or prosthesis, 70 as it is in
`passageway 80 upon de?ation of angioplasty balloon 88,
`serted into the lumen 81 of body passageway 80, as to be
`nor will the expansion of intraluminal graft 70 likely
`hereinafter described in greater detail. The remaining
`cause a rupture of body passageway 80. Further, should
`retainer ring member 86 as shown in FIG. 3, slopes
`an intimal ?ap, or ?ssure, be formed in body passage
`downwardly away from tip 87 of catheter 83, to insure
`way 80 at the location of graft 70, graft 70 will insure
`easy removal of catheter 83 from body passageway 80.
`that such an intimal ?ap will not be able to fold in
`After expandable intraluminal graft, or prosthesis, 70
`wardly into body passageway 80, nor tear loose and
`has been disposed upon catheter 83, in the manner pre
`flow through body passageway 80. In the situation of
`viously described, the graft, or prosthesis, 70 and cathe
`utilizing graft 70 in the manner previously described to
`ter 83 are inserted within a body passageway 80 by
`expand the lumen of a portion of the left main