US005195
`5,195,984
`[11] Patent Number:
`{15
`United States Patent
`Schatz
`[45] Date of Patent: Mar. 23, 1993
`
`
`nc
`
`{54} EXPANDABLE INTRALUMINAL GRAFT
`.
`[75]
`Inventor: Richard A. Schatz, Paradise Valley,
`Ariz.
`
`[73] Assignee: Expandable Grafts Partnership, San
`Antonio, Tex.
`
`4,776,337 10/1988 Palrmaz ......ssccsesessseseesererrersees 623/1
`
`1/1989 Gianturio..
`. 128/343
`4,800,882
`8/1989 Hillstead...
`4,856,516
`623/12
`4,969,458 11/1990 Wiktor..
`606/194
`
`$,102,417 4/1992 Palmaz ..
`606/195
`5,135,536 8/1992 Hillstead creo. 606/195
`OTHER PUBLICATIONS
`
`[21] Appl. No.: 657,296
`
`.
`
`[22] Filed:
`
`[63]
`
`[56]
`
`“Self-Expanding Endovacular Graft: An Experimental
`Feb. 19, 1991
`Study in Dogs” 151 AJR 673-76, Oct. 1988 (first made
`available to the public on Sep. 20, 1988).
`Related U.S. Application Data
`Primary Examiner—PaulPrebilic
`Continuation of Ser. No. 253,115, Oct. 4, 1988, aban.
`Attorney, Agent, or Firm—Ben D. Tobor
`doned.
`
`(S1] Ent, CUS noccccsscsssssscesetsssnssesseneesssveses A61M 29/00=‘[57] ABSTRACT
`[52] US. C1, ceseesessecstesesestesnteneerecess 606/195; 606/193;
`4 plurality of expandable and deformable intraluminal
`606/194; 623/1; 604/104; 604/96
`vascular grafts are expanded within a blood vessel by an
`[58] Field of Search .............-..+ 600/36; 604/96, 104;
`angioplasty balloon associated with a catheter to dilate
`606/193, 194, 195; 623/1, 12
`and expand the lumen of a blood vessel. The grafts may
`References Cited
`be thin-walled tubular members having a plurality of
`U.S. PATENT DOCUMENTS
`slots disposed substantially parallel to the longitudinal
`axis of the tubular members, and adjacent grafts are
`3,744,596 11/1973 Cook ......
`flexibly connected by a single connector memberdis-
`see 128/343
`
`al.
`4,512,338 4/1985 Balko et
`posed substantially parallel to the longitudinal axis of
`~~ 128/341
`128/341
`4,553,545 11/1985 Maass et al.
`
`the tubular members.
`. eon
`4,733,665
`3/1988 Palmaz......
`
`4,739,762 4/1988 Palmaz ..
` 6 Claims, 3 Drawing Sheets
`4,760,849
`8/1988 Kropf........
`
`Abbott
`Exhibit 1026
`Page 001
`
`Abbott
`Exhibit 1026
`Page 001
`
`

`

`U.S. Patent
`
`Mar.23, 1993
`
`Sheet 1 of 3
`
`5,195,984
`
`ay (PRIORART)
` fiy-
`
`(PRIORART)
`
`78
`
`1
`
`Abbott
`Exhibit 1026
`Page 002
`
`Abbott
`Exhibit 1026
`Page 002
`
`

`

`U.S. Patent
`
`Mar. 23, 1993
`
`Sheet 2 of 3
`
`5,195,984
`
`86
`
`95
`
`81
`
`Fic 3
`85
`72 70
`g5
`84
`93
`(PRIOR ART)
`
`
`és
`88
`85
`
`
`
`
`
`LILITLLIIITTI
`
`naonninTicS77freer
`
`Fic
`
`89
`
`}
`wera
`
`(PRIOR ART)
`
`Fig-5
`{PRIOR ART) _
`
`on
`
`#0
`
`1h
`
`94
`
`9h
`
`
`Fic 6
`
`(PRIOR ART)
`
`Abbott
`Exhibit 1026
`Page 003
`
`Abbott
`Exhibit 1026
`Page 003
`
`

`

`U.S. Patent
`
`Mar. 23, 1993
`
`Sheet 3 of 3
`
`5,195,984
`
`
`
`Abbott
`Exhibit 1026
`Page 004
`
`Abbott
`Exhibit 1026
`Page 004
`
`

`

`1
`
`5,195,984
`
`EXPANDABLE INTRALUMINAL GRAFT
`
`This application is a division of application Ser. No.
`07/253,115,filed Oct. 4, 1988 now abandoned.
`1. Field of the Invention
`
`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.
`
`15
`
`2. 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 percutaneousinsertion
`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 woundcoil springs manufactured
`from an expandableheat-sensitive material: and expand-
`ing stainless steel stents formedofstainiess 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 final, expanded
`configuration of each structure. For example, the ex-
`pansion ofa particular coiled spring-type graft is prede-
`termined by the spring constant and modulusofelastic-
`ity of the particular material utilized to manufacture the
`coiled spring structure. These same factors predeter-
`mine the amount of expansion of collapsed stents
`formedofstainless steel wire in a zig-zag pattern. In the
`case of intraluminal grafts, or prostheses, formed of a
`heatsensitive 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 expandedat the desired location within a body pas-
`sageway, such as within an artery or vein, the expanded
`size of the graft cannot be changed. If the diameter of
`the desired body passageway has been miscalculated, an
`undersized 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. Further,
`the constant outwardly
`radiating force exerted upon the interior surface of the
`body passageway can causeerosion of the internal sur-
`face, or intima, of the artery or body passageway.
`Anotheralternative to conventional vascular surgery
`has been percutaneous balloon dilation of elastic vascu-
`lar stenoses, or blockages, through use of a catheter
`
`40
`
`45
`
`50
`
`55
`
`60
`
`_ 65
`
`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 atherosclerotic 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 fissuring. This dissection forms a “flap” of un-
`derlying tissue which may reduce the blood flow
`through the lumen, or block the lumen. Typically, the
`distending intraluminal pressure within the body pas-
`sageway can hold the disrupted layerorflap,in place. If
`the intima! flap created by the balloon dilation proce-
`dure is not maintained in place against the expanded
`intima, the intimal flap can fold down into the lumen
`and close off the lumen, or may even become detached
`and enter the body passageway. Whentheintimal flap
`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 ofthe foregoing problem,it is always necessary to
`have a surgeon oncall should the intimal flap block the
`blood vessel or body passageway. Further, because of
`the possibility of the intimal flap tearing away from the
`blood vessel and blocking the lumen,balloon dilations
`cannot be performed uponcertain critical body passage-
`ways, such as the left main coronary artery, which leads
`into the heart. If an intimal flap formed by a balloon
`dilation procedure abruptly comes down and closesoff
`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 fibrocollagenous content in
`the lesion and is sometimes due to certain mechanical
`characteristics of the area to be dilated. Thus, although
`the body passageway mayinitially be successfully ex-
`panded by a balloon dilation procedure, subsequent,
`early restenosis can occur due to the recoil of the body
`passageway wall which decreasesthe size of the previ-
`ously expanded lumen of the body passageway. For
`example, stenoses of the renal artery at the ostium are
`knownto 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 fibrosis, 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 neurofibromatosis arterial
`stenoses may show poorinitial response and recurrence
`which is believed due to the fibrotic nature of these
`lesions.
`Forrepairing blood vessels narrowed or occluded by
`disease, or repairing other body passageways,
`the
`length of the body passageway which requires repair, as
`by the insertion of a tubular prosthetic graft, may pres-
`ent problemsif the length of the required graft cannot
`negotiate the curves or bends of the body passageway
`
`Abbott
`Exhibit 1026
`Page 005
`
`Abbott
`Exhibit 1026
`Page 005
`
`

`

`5,195,984
`
`4
`gate bar member, coplanar with adjacent tubular mem-
`bers. An additional feature of the present invention is
`that a first connector member may be disposed between
`the second end ofa first tubular member andthefirst
`end of a second tubular member; a second connector
`member maybe disposed between the second endofthe
`second tubular memberandthefirst end of a third tubu-
`lar member; the first and second connector members
`being angularly offset from one another with respect to
`the longitudinal axis of the tubular members.
`The expandable intraluminal vascular graft of the
`~ present
`invention, when compared with previously
`proposed prior art intraluminal grafts, has the advan-
`tages of: preventing recurrence of stenoses;is believed
`to permit implantation ofgrafts in critical body passage-
`ways, such as in the left main coronaryartery of the
`heart; prevents recoil of the body passageway; prevents
`erosion of the body passageway by the expanded graft;
`permits expansion of the graft to a variable size depen-
`dent upon conditions within the body passageway; per-
`mits tissue of an elongated section of a body passageway
`to be supported byan elongated graft; and provides the
`necessaryflexibility to negotiate the bends and curvesin
`tortuous body passageways, such as the vascular sys-
`tem.
`
`_ 0
`
`20
`
`3
`through which the graft is passed by the catheter. In
`other words, in many instances,it is necessary to sup-
`port a length of tissue within a body passageway by a
`graft, wherein the length of the required graft exceeds
`the length of a graft which can be readily delivered via
`a catheter to the desired location within the vascular
`system. Some grafts do not have the requisite ability to
`bend so as to negotiate the curves and bends present
`within the vascular system, particularly prostheses or
`grafts which are relatively rigid and resist bending with
`respect to their longitudinal axes.
`Accordingly, prior to the developmentof the present
`invention, there has been no expandable intraluminal
`vascular graft for expanding the lumen of a body pas-
`sageway, which:prevents recurrence of stenoses in the
`body passageway; can be utilized for critical body pas-
`sageways, such as the left main coronary artery of a
`patient’s heart; prevents recoil of the body passageway
`wall; allows the intraluminal graft to be expanded to a
`variable size to prevent migration of the graft away
`from the desired location and prevents rupturing and-
`/or erosion of the body passageway by the expanded
`graft; permits tissue of an elongated section of a body
`passageway to be supported by an elongated graft; and
`providesthe necessaryflexibility to negotiate the bends
`and curvesin the vascular system. Therefore, the art has
`sought an expandable intraluminal vascular graft which:
`prevents recurrence of stenoses in the body passage-
`way; is believed to be able to beutilized in critical body
`passageways, suchas the left main coronary artery of 30
`the heart; prevents recoil of the body passageway; can
`be expandedto a variable size within the body passage-
`way to prevent migration of the graft away from the
`desired location and to prevent rupturing and/or ero-
`sion of the body passageway by the expanded graft;
`per mits tissue of an elongated section of a body passage-
`way to be supported by an elongated graft; and pro-
`vides the necessary flexibility to negotiate the bends and
`curves in the vascular system.
`SUMMARYOF THE INVENTION
`
`In accordance with the invention, the foregoing ad-
`vantages have been achieved by the present expandable
`intraluminal vascular graft. The present invention in-
`cludes a plurality of thin-walled tubular members, each
`having first and second endsand a wall surface disposed
`between the first and second ends, the wall surface
`having a substantially uniform thickness and a plurality
`of slots formed therein, the slots being disposed substan-
`tially parallel to the longitudinal axis of each tubular
`member; a single connector member being disposed
`between adjacent tubular members to flexibly connect
`adjacent tubular members, the single connector member
`being disposed in a substantially parallel relationship
`with respect to the longitudinal axis of the tubular mem-
`bers and coplanar with each tubular member; each tubu-
`lar member having a first diameter which permits intra-
`luminal delivery of the tubular members into a body
`passageway having a lumen; and the tubular members
`having a second, expanded and deformed diameter,
`upon the application from the interior of the tubular
`members of a radially, outwardly extending force,
`which second diameter is variable and dependent upon
`the amount of force applied to the tubular members,
`whereby the tubular members may be expanded and
`deformed to expand the lumen of the body passageway.
`A further feature of the present invention is that the
`single connector member may be a thin-walled, elon-
`
`45
`
`50
`
`60
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`In the drawings:
`FIG.1Ais a perspective view of an expandable intra-
`luminal vascular graft, or prosthesis for a body passage-
`way, having a first 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 configuration when
`disposed within a body passageway;
`FIG. 2 is a cross-sectional view of the prosthesis
`taken along line 2—2 of FIG. 1B;
`FIG. 3 is a cross-sectional view of an apparatus for
`intraluminally reinforcing a body passageway, or for
`expanding the lumenof a body passageway,illustrating
`a prosthesis, or intraluminal vascular graft, in the con-
`figuration shown in FIG. 1A;
`FIG. 4 is a cross-sectional view of the apparatus for
`intraluminally reinforcing a body passageway, or for
`expanding the lumen of a body passageway, with the
`graft, or prosthesis, in the configurations shown in FIG,
`1B;
`FIGS.5 and 6 are perspective views of prostheses for
`a body passageway, with the grafts, or prostheses, hav-
`ing a coating thereon;
`FIG.7 is a perspective view of another embodiment
`of a graft or prosthesis in accordance with the present
`invention; and
`FIG.8 is a perspective view of the graft of FIG.7,
`wherein the graft has been bentor articulated.
`While the invention will be described in connection
`with the preferred embodiment, it will be understood
`that it is not intendedto limit the invention to that em-
`bodiment. On the contrary, it is intended to coverall
`alternatives, modifications, and equivalents, as may be
`included within the spirit and scope of the invention as
`defined by the appended claims.
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`In FIGS. 1A and 1B, an expandable intraluminal
`vascular graft, or expandable prosthesis for a body pas-
`sageway, 70 is illustrated. It should be understood that
`
`Abbott
`Exhibit 1026
`Page 006
`
`Abbott
`Exhibit 1026
`Page 006
`
`

`

`5,195,984
`
`—0
`
`_ th
`
`20
`
`25
`
`5
`the terms “expandable intraluminal vascular graft” and
`“expandable prosthesis” are interchangeably used to
`some extent in describing the present invention, insofar
`as the methods, apparatus, and structures of the present
`invention may be utilized not only in connection with
`an expandable intraluminal vascular graft for expanding
`partially occluded segments of a blood vessel, or body
`passageway, but mayalso be utilized for many other
`purposes as an expandable prosthesis for many other
`types of body passageways. For example, expandable
`prostheses 70 mayalso be used for such purposesas: (1)
`supportive graft placement within blocked arteries
`opened by transluminal recanalization, but which are
`likely to collapse in the absence of an internal support;
`(2) similar use following catheter passage through medi-
`astinal and other veins occluded by inoperable cancers;
`(3) reinforcementof catheter created intrahepatic com-
`munications between portal.and hepatic veins in pa-
`tients suffering from portal hypertension; (4) supportive
`graft placement ofnarrowing of the esophagus, the
`intestine, the ureters, the urethra; and (5) supportive
`graft reinforcement of reopened and previously ob-
`structed bile ducts. Accordingly, use of the term “pros-
`thesis” encompasses the foregoing usages within vari-
`ous types of body passageways,and the use of the term
`“intraluminal vascular graft” encompasses use for ex-
`panding the lumen of a body passageway. Further, in
`this regard, the term “body passageway” encompasses
`any duct within the human body, such as those previ-
`ously described, as well as any vein, artery, or blood
`vesse] within the human vascular system.
`Still with reference to FIGS. 1A and 1B, the expand-
`able intraluminal vascular graft, or prosthesis, 70 is
`shownto generally comprise a tubular member 71 hav-
`ing first and second ends 72, 73 and a wall surface 74
`disposed between thefirst and second ends 72, 73. Tu-
`bular member 71 has a first diameter, d, which, to be
`hereinafter described in greater detail, permits intralu-
`minal delivery of the tubular member 71 into a body
`passageway 80 having a lumen 81 (FIG.3). With refer-
`ence to FIG. 1B, upon the application from the interior
`of the tubular member 71 ofa radially, outwardly ex-
`tending force, to be hereinafter described in greater
`detail tubular member 71 has a second, expanded diame-
`ter, d’, which second diameter d, is variable in size and
`dependent upon the amountof force applied to deform
`the tubular member 71.
`Tubular member 71, may be any suitable material
`which is compatible with the human body and the bod-
`ily fluids (not shown) with which the vascular graft, or
`prosthesis, 70 may comeinto contact. Tubular member
`71 must also be made of a material which has the requi-
`site strength and elasticity characteristics to permit the
`tubular member 71 to be expanded and deformed from
`the configuration shown in FIG. 1A to the configura-
`tion shownillustrated in FIG. 1B and further to permit
`the tubular member 71 to retain its expanded and de-
`formed configuration with the enlarged diameter d’
`shownin FIG. 1B and resist radial collapse. Suitable
`materials for the fabrication of tubular member 71
`would include silver,
`tantalum, stainless steel, gold,
`titanium or any suitable plastic material having the req-
`uisite characteristics previously described.
`Preferably,
`tubular member 71 is initially a thin-
`walled stainless steel tube having a uniform wall thick-
`ness, and a plurality of slots 82 are formed in the wall
`surface 74 of tubular member 71. As seen in FIG. 1A
`when tubular member 71 has thefirst diameter d, the
`
`6
`slots 82 are disposed substantially parallel to the longitu-
`dinal axis of the tubular member71. As seen in FIG. 1A,
`the slots 82 are preferably uniformly and circumferen-
`tially spaced from adjacent slots 82, as by connecting
`members 77, which connecting members 77 preferably
`have a length equal to the width ofslots 82, as seen in
`FIG. 1A. Slots 82 are further uniformly spaced from
`adjacentslots 82 along the longitudinal axis of the tubu-
`lar member 71, which spacing is preferably equal to the
`width of connecting members 77. Thus, the formation
`of slots 82 results in at Jeast one elongate member 75
`being formed between adjacentslots 82, elongate mem-
`ber 75 extending between the first and second ends, 72,
`73 of tubular member 71, as seen in FIG. 1A.
`Still with reference to FIG. 1A, each slot will have
`first and second ends with a connecting member 77
`disposed atthefirst and second endsofslots 82. Prefera-
`bly, the first and second ends of each slot 82 are dis-
`posed intermediate the first and second endsof adjacent
`slots 82 along the longitudinal axis of the tubular mem-
`ber 71. Thus, connecting members 77, which are dis-
`posed at the first and second ends of each slot 82, and
`between elongate members 75, will in turn be disposed
`intermediate thefirst and second ends of adjacent slots
`82 along the longitudinal axis of the tubular member 71.
`Accordingly, slots 82 are preferably uniformly and
`circumferentially spaced from adjacentslots, and slots
`82 adjacentto one another along the longitudinal axis of
`tubular member 71 are in a staggered relationship with
`one another. Alternating slots disposed about the cir-
`cumference of tubular member 71 at both thefirst and
`second ends 72, 73 of tubular member 71 will only have
`a length equal to approximately one-half ofthe length of
`a completeslot 82, such half-slot 82 being bounded by
`members78, 79, at both thefirst and second ends 72, 73
`of tubular member 71. Although the graft, or prosthesis,
`70 of FIGS. 1A and 1Bis illustrated to have a length
`approximately equal to the length of twoslots 82,it
`should be apparent that the length of the graft 70 could
`be made longeror shorter as desired.
`The foregoing described construction of graft, or
`prosthesis, 70 permits graft, or prosthesis, 70 to be ex-
`panded uniformly, and outwardly, in a controlled man-
`ner into the configuration shown in FIG. 1B, upon the
`application of a suitable force from the interior of tubu-
`lar member 71, as will be hereinafter described in
`greater detail. The expansion of tubular member 71 into
`the configuration shown in FIG.1B is further uniform
`along the length of tubular member71, not only because
`of the uniform spacing between slots 82, as previously
`described, but also because the thickness of the wall
`surface 74, or the thickness of connecting members 77,
`elongate members 75, and members 78, 79, is the same
`uniform thickness. As illustrated in FIG. 2, the uniform
`thickness of elongate member 75 is shown, and the
`preferred cross-sectional configuration of elongate
`member 75, connecting member 77, and members 78,
`79, is illustrated, which configuration is rectangular. It
`should of course be understood by those skilled in the
`art, that the cross-sectional configuration of the forego-
`ing components ofgraft, or prosthesis, 70 could also be
`square, rectangular, or other cross-sectional configura-
`tions. As will be hereinafter described in greater detail,
`it is preferable that the outer surface 74 of graft, or
`prothesis, 70, which would be in contact with the body
`passageway 80 FIG.4, should be relatively smooth.
`With reference to FIG. iB, it is seen that after the
`graft, or prosthesis 70, has been expanded and deformed
`
`40
`
`45
`
`60
`
`Abbott
`Exhibit 1026
`Page 007
`
`Abbott
`Exhibit 1026
`Page 007
`
`

`

`= 0
`
`into the configuration of FIG. IB, the slots 82 will as-
`sume a substantially hexagonal configuration when the
`tubular member 71 has the second, expanded diameter,
`d’, as shown in FIG. 1B. Such a hexagonal configura-
`tion will result when theslots 82 initially have a substan-
`tially rectangular configuration when the tubular mem-
`ber 71 has the first diameter,d, illustrated in FIG. 1A.It
`should be noted that were the width of slots 82 to be
`substantially reduced, whereby the length of connect-
`ing member 77 would approximatea single point inter-
`section,
`the expansion of such a tubular member 71
`would result in slots 82 assuming a configuration which
`would be substantially a parallelogram (not shown).
`It should be noted that not only is tubular member 71
`expanded from the configuration shown in FIG. 1A to
`achieve the configuration shown in FIG. 1B, but tubu-
`lar member 71 is further “deformed” to achieve that
`configuration. By use of the term “deformed”is meant
`that the material from which graft, or prosthesis, 70 is
`manufactured is subjected to a force which is greater
`than the elastic limit of the material utilized to make
`tubular member 71. Accordingly, the force is sufficient
`to permanently bend elongate members 75 whereby
`segments of the elongate members 75 pivot about con-
`necting members 77 and movein a circumferential di-
`rection as they pivot, whereby the diameter ofthe tubu-
`lar member 71 increases from the first diameter, d, to
`the expanded diameter, d’, of FIG. 1B. The force to be
`applied to expand tubular member 71, which is applied
`in the manner which will be hereinafter described in
`greater detail, must thus be sufficient to not only expand
`tubular member71, but also to deform elongate member
`75, in the manner previously described, whereby the
`portions of the elongate members 75 which pivot about
`the ends of connecting members 77 do not “spring
`back” and assume their configuration shown in FIG.
`1A,but rather retain the configuration thereof in FIG.
`1B. Oncegraft, or prosthesis, 70 has been expanded and
`deformed into the configuration shown in FIG. 1B,
`graft, or prosthesis 70, will serve to prevent a body
`passageway from collapsing as will be hereinafter de-
`scribed in greater detail. It should be noted that when
`tubular member 71 has the first diameter, d, shown in
`FIG.1A,or after tubular member 71 has been expanded
`and deformed into the second, expanded diameter, a’, of 45
`FIG. 1B, tubular member 71 does not exert any out-
`ward, radial force, in that tubular member 71 is not a
`“spring-like” or
`“self-expanding member”, which
`would tend to exert an outwardly radial force.
`With reference now to FIGS. 3 and 4, apparatus of 50
`the present invention will be described in greater detail.
`Once again, it should be understood that the apparatus
`of the present invention is useful not only for expanding
`the lumen of a body passageway, such as an artery, vein,
`or blood vessel of the human vascular system, but are
`also useful to perform the previously described proce-
`dures to intraluminally reinforce other body passage-
`ways or ducts, as previously described. Still with refer-
`ence to FIGS.3 and 4, an expandable intraluminal vas-
`cular graft, or prosthesis, 70, of the type described in
`connection with FIGS. 1A and 1B,
`is disposed or
`mounted upon a catheter 83. Catheter 83 has an expand-
`able, inflatable portion 84 associated therewith. Cathe-
`ter 83 may include means for mounting andretaining 85
`the expandable intraluminal vascular graft, of prosthe-
`sis, 70 on the expandable, inflatable portion 84 of cathe-
`ter 83. The mounting and retaining means 85 could
`comprise retainer ring members 86 disposed on the
`
`40
`
`60
`
`65
`
`5,195,984
`
`8
`catheter 83 adjacent the expandable inflatable portion
`84 of catheter 83; and a retainer ring member86is dis-
`posed adjacent each end 72, 73 of the expandable intra-
`luminal vascular graft, or prosthesis, 70. As seen in FIG.
`3, retainer ring members could be formed integral with
`catheter 83, and the retainer ring member 86 adjacent
`the leading tip 87 of catheter 83 slopes upwardly and
`away from catheter tip 87 in order to protect and retain
`graft or prosthesis, 70 asit is inserted into the lumen 81
`of body passageway80, as to be hereinafter described in
`greater detail. The remaining retainer ring member 86
`as shownin FIG. 3, slopes downwardly away from tip
`87 of catheter 83, to insure easy removalof catheter 83
`from body passageway 80. After expandable intralu-
`minal graft, or prosthesis, 70 has been disposed upon
`catheter 83,
`in the manner previously described, the
`graft, or prosthesis, 70 and catheter 83 are inserted
`within a body passageway 80 by catheterization of the
`body passageway 80 in a conventional manner.
`In a conventional manner, the catheter 83 and graft,
`or prosthesis, 70 are delivered to the desired location
`within the body passageway 80, whereatit is desired to
`expand the lumen 81of body passageway 80 via intralu-
`minal graft 70, or whereit is desired to implant prosthe-
`sis 70. Fluoroscopy, and/or other conventional tech-
`niques maybeutilized to insure that the catheter 83 and
`graft, or prosthesis, 70 are delivered to the desired loca-
`tion within the body passageway. Prosthesis, or graft,
`70 is then controllably expanded and deformed by con-
`trollably expanding the expandable, inflatable portion
`84 of catheter 83, whereby the prosthesis, or graft, 70 is
`expanded and deformed radially, outwardly into
`contact with the body passageway 80, as shownin FIG.
`4. In this regard, the expandable, inflatable portion of
`catheter 83 may be a conventional angioplasty balloon
`88. After the desired expansion and deformation of
`prosthesis, or graft, 70 has been accomplished, angio-
`plasty balloon 88 maybe collapsed, or deflated, and the
`catheter 83 may be removed in a conventional manner
`from body passageway 80.If desired, as seen in FIG.3,
`catheter 83, having graft or prosthesis, 70 disposed
`thereon, may beinitially encased in a conventional Tef-
`lon sheath 89, or a sheath 89 made of another suitable
`material, which is pulled away from prosthesis, or graft,
`70, prior to expansion of the the prosthesis, or graft, 70.
`Still with reference to FIGS. 3 and 4, it should be
`noted that tubular member 71 of prosthesis, or graft, 70
`initially has the first predetermined, collapsed diameter,
`d, as described in connection with FIG.1A,in order to
`permit the insertion of the tubular member, 71 into the
`body passageway 80 as previously described. Whenitis
`desired to implant prosthesis 70 within a body passage-
`way 80 for the purposes previously described, the pros-
`thesis 70 is, controllably expanded and deformedto the
`second diameter, d’, and the second, expanded diame-
`ter, d,, is variable and determined bythe internal diame-
`ter of the body passageway80, as shown in FIG.4, and
`by the amountof expansionofthe inflatable portion 84
`of catheter 83. Accordingly,
`the expanded and de-
`formed prosthesis 70, upon deflation of angioplasty
`balloon 88 will not be able to migrate from the desired
`location within the body passageway 80, nor will the
`expansion of the prosthesis 70 be likely to cause a rup-
`ture of the body passageway 80. Furthermore,insofar as
`prosthesis, or graft, 70 is not a “spring-like” or “self-
`expanding member”, the prosthesis is not consistently
`applying an outward, radial force against the interior
`surface of body passageway 80,
`in excess of that re-
`
`Abbott
`Exhibit 1026
`Page 008
`
`Abbott
`Exhibit 1026
`Page 008
`
`

`

`_0
`
`oe uu
`
`20
`
`quired to resist radial collapse of the body passageway
`80. Thus, erosion of the interior surface, or intima, of
`the artery or body passageway is prevented.
`When it is desired to use expandable intraluminal
`graft 70 to expand the lumen 81 of a body passageway
`80 having an area of stenosis, the expansion of intralu-
`minal vascular graft 70 by angioplasty balloon 88, al-
`lows controlled dilation of the stenotic area and, at the
`same time controlled expansion and deformation of the
`vascular graft 70, whereby vascular graft 70 prevents
`the body passageway 80 from collapsing and decreasing
`the size of the previously expanded lumen 81. Once
`again, the second, expanded diameter d'ofintraluminal
`vascular graft 70, as shown in FIG.4, is variable and
`determined by the desired expanded internal diameter
`of body passageway 80. Thus, the expandableintralu-
`minal graft 70 will not migrate away from the desired
`location within the body passageway 80 upon deflation
`of angioplasty balloon 88, nor will the expansion of
`intraluminal graft 70 likely cause a rupture of body
`passageway 80, nor any erosion as previously described.
`Further, should an intimal flap, or fissure, be formed in
`body passageway 80 at the location