United States Patent [19]
`Lunn
`
`[54] BI-DIRECTIONAL CRIMPED GRAFT
`
`[75]
`
`Inventor: Anthony C. Lunn, Princeton, N.J.
`
`[73] Assignee: Ethicon, Inc., Somerville, N.J.
`
`[21] Appl. No.: 193,314
`
`Feb. 8,1994
`
`[22] Filed:
`[51] Int. CI.6
`[52] U.S. CI
`[58] Field of Search
`
`A61F 2/06
`623/1; 623/9; 623/12
`623/1, 12, 9; 606/192,
`606/194, 195, 197
`
`[56]
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3,688,317 9/1972 Kurtz
`3,878,565 4/1975 Sauvage
`4,164,045 8/1979 Bokros et al
`4,313,231 2/1982 Koyamada
`4,545,082 10/1985 Hood
`4,787,899 11/1988 Lazarus
`4,816,028 3/1989 Kapadia et al
`5,108,424 4/1992 Hoflinan et al
`5,282,847 2/1994 Trescony et al
`
`623/1
`623/1
`128/334
`623/1
`623/1
`623/1
`623/1
`623/1
`623/1
`
`inn in ii
`iiiiiiiiiiiiiiiiiiiniii
`5,476,506
`Dec. 19, 1995
`
`US005476506A
`[ii] Patent Number:
`[45] Date of Patent:
`
`4/1994
`11/1994
`
`Winston et al
`5,306,294
`Winston et al
`5,366,473
`Primary Examiner—David H. Willse
`Assistant Examiner—Bruce E. Snow
`Attorney, Agent, or Firm—Paul A. Coletti
`
`[57]
`
`ABSTRACT
`
`623/1
`623/12
`
`This invention relates to a graft for placement in a body
`passageway. The graft comprises a longitudinally extending
`thin walled cylinder having first and second open ends. The
`graft is divided into first and second axially extending end
`portions adjacent such open ends and an axially extending
`central portion therebetween. The walls of the central por(cid:173)
`tion are provided with circumferential crimps and the wall of
`the end portions are provided with axially extending crimps
`whereby the central portion can be extended longitudinally
`to vary the distance between the end portions and the end
`portions may be expanded radially to vary the diameter of
`the end portions. In preferred embodiment the end portions
`have a greater diameter than the central portion imparting to
`the graft a somewhat dumbbell like shape preferable in
`employing the graft in the reduced diameter lumen of a
`diseased blood vessel.
`
`21 Claims, 4 Drawing Sheets
`
`Edwards Lifesciences Corporation, et al. Exhibit 1134, Page 1 of 9
`
`

`

`U.S. Patent
`
`Dec. 19, 1995
`
`Sheet 1 of 4
`
`5,476,506
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`FIG.2
`
`FIG.3
`
`r 18
`
`VL-V-.V'rV-T^l
`
`D
`
`; S
`
`\ N ^
`
`Edwards Lifesciences Corporation, et al. Exhibit 1134, Page 2 of 9
`
`

`

`U.S. Patent
`
`Dec. 19, 1995
`
`Sheet 2 of 4
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`5,476,506
`
`F1G.4
`
`Edwards Lifesciences Corporation, et al. Exhibit 1134, Page 3 of 9
`
`

`

`U.S. Patent
`
`Dec. 19, 1995
`
`Sheet 3 of 4
`
`5,476,506
`
`CD
`
`sf o
`m
`CD
`Li.
`
`CO
`sf Q
`LO
`CD
`LL.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1134, Page 4 of 9
`
`

`

`U.S. Patent
`
`Dec. 19, 1995
`
`Sheet 4 of 4
`
`5,476,506
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`FIG.6A
`
`/
`
`16
`
`FIG.6B
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`/
`
`^0
`
`53
`
`Edwards Lifesciences Corporation, et al. Exhibit 1134, Page 5 of 9
`
`

`

`5,476,506
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`BI-DIRECTIONAL CRIMPED GRAFT
`
`freedom in choosing a proper graft size. Therefore, it is
`desirable for the manufacturer to provide the doctor with a
`wider range of elastic expansion than is assured by reliance
`on the inherent elasticity of the graft materials of construc(cid:173)
`tion.
`Accordingly, there is a need for a graft which provides
`great freedom of both longitudinal and radial expansion at
`the central and end portions, respectively.
`
`SUMMARY OF THE INVENTION
`
`In accordance with the teachings herein, a graft is pro(cid:173)
`vided which has longitudinal elasticity whereby the doctor
`employing the same may adjust the length of the graft within
`wide limits that are virtually independent of the materials of
`construction. Further, the graft is provided at its end portions
`with radial elasticity whereby the end portions may be
`expanded to diameters by such graft affixing devices as
`stents wherein such expansion again is virtually independent
`of the materials of construction.
`Consistent with the teachings herein, such a graft is
`provided for placement in a body passageway, the graft
`comprising a longitudinally extending thin walled hollow
`cylinder having first and second open ends. The graft is
`divided into first and second axially extending end portions
`adjacent such first and second open ends, respectively, and
`an axially extending central portion therebetween. The walls
`of the central portion are provided with circumferential
`crimps and the walls of the end portion are provided with
`axially extending crimps whereby the central portion can be
`extended longitudinally from its relaxed position to vary the
`distance between the end portions. ITie circumferential
`crimps serve also to render the central portion of the graft
`more flexible and capable of conforming to curves in the
`vascular system without undesirable kinking. The end por(cid:173)
`tions may be expanded radially to vary the diameter of said
`end portions as is advantageous, when affixing such end
`portions with an expandable stent. In a preferred embodi(cid:173)
`ment the end portions have greater diameter in the relaxed
`state than the central portion, imparting to the graft a
`somewhat dumbbell shape. Such shape is preferable in that
`it most closely resembles the shape of the lumen of a
`diseased section of blood vessel and hence, avoids kinks and
`folds which would otherwise occur in a graft of uniform
`diameter as it conforms to the lumen of the blood vessel.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a perspective view of a graft embodying the
`teaching of this invention;
`FIG. 2 is a transverse cross sectional view of an end
`portion of the graft of FIG. 1, taken through line 2—2 of
`FIG. 1;
`FIG. 3 is an axially extending, cross sectional view of the
`graft of FIG. 1, taken through line 3—3 of FIG. 1;
`FIG. 4 is a schematic axially extending cross sectional
`view of the graft of FIG. 1 placed within a diseased blood
`vessel;
`FIGS. 5a through 5d are schematic elevational views of
`the graft of FIG. 1 mounted on a balloon catheter delivery
`system in various stages in the course of emplacing such
`graft into a blood vessel; and
`FIGS. 6a and 6b are transverse cross sectional views
`illustrating one method of carrying the graft on the delivery
`system.
`
`5
`
`10
`
`BACKGROUND OF THE INVENTION
`This invention relates generally to prostheses for repairing
`diseased or damaged sections of a body passageway and
`more specifically to vascular grafts for repair of damaged or
`diseased sections of body vessels such as blood vessels.
`Diseased or damaged blood vessels which may weaken,
`develop into aneurysms and rupture have conventionally
`been treated by invasive surgical techniques which surgi(cid:173)
`cally expose the section to be repaired. The section is
`resected and replaced either by a section of healthy vessel
`removed from some other site of the patient or by a tubular
`synthetic graft. The graft is sutured in place. Alternatively, it 15
`has been suggested in U.S. Pat. Nos. 3,657,744 and 5,078,
`726, that the graft be held in place by stents disposed inside
`the end portions of the graft and expanded to firmly affix the
`end portion walls of the graft between the expanded stent
`and the vessel walls.
`Recently, it has been suggested to replace the invasive
`surgical techniques and the treatment of diseased or dam(cid:173)
`aged iliac or aortic vessels with so-called minimally invasive
`or interventional procedures whereby a small incision in a „
`femoral artery of the patient is made and the graft-stent
`combination is delivered to the desired site by way of
`catheterization. Once delivered, the graft is affixed in place
`by expanding the stent and, in order to do this without
`invasive surgery, such expansion is accomplished by use of 3Q
`one or more angioplasty-like balloon catheters with the
`inflation balloon or balloons employed to expand each of
`these stents. Such systems and suggestions are described in
`U.S. Pat. Nos. 4,577,631 and 5,078,726.
`
`20
`
`As described in the above-cited patents, the tubular graft 35
`is inserted into the vessel and is of a length sufficient to span
`the weakened sections of the blood vessel to be repaired and
`to overlap the healthy sections on either side of the weak(cid:173)
`ened section. Once emplaced, the ends of the graft are
`affixed to the healthy sections by expanding a stent placed 40
`therein. The length of the weakened section will of course,
`vary from case to case. Because it is desirable to employ a
`length of graft which is sufficient to span the weakened
`section and only a minimal length of healthy sections
`necessary for good retention, reasonably close tolerances are 45
`necessary in properly choosing a length of graft to be
`employed. Ultimately, irrespective of the length provided by
`the manufacturer or selected by the doctor, fine adjustments
`must be made in a length in order to properly emplace the
`graft. Heretofore, these adjustments have been accom- 50
`plished by virtue of the longitudinal elasticity, if any, present
`in the materials of construction from which the grafts are
`manufactured. Since such elasticity is relatively limited and,
`in some cases, nonexistent, the great burden of choosing the
`proper length of graft has been left to the skill of the doctor 55
`and frequently has presented the doctor with difficulties.
`A similar problem exists at the ends of the graft wherein
`the ends of the graft are held in place by being sandwiched
`between the healthy portion of the blood vessel and an
`expanded stent. In order to do this, the end portions of the 60
`graft must be such that they can be affixed to the stent when
`the stent is unexpanded and then increased in diameter,
`together with the stent as the stent is expanded towards the
`walls of the blood vessel. Accordingly, the ends of the graft
`must also have elasticity, albeit radial elasticity. Again, while 65
`to a degree and some graft materials are inherently elastic in
`the radial direction, it is important to increase the degrees of
`
`Edwards Lifesciences Corporation, et al. Exhibit 1134, Page 6 of 9
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`

`

`5,476,506
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`Referring now to the drawings, FIGS. 1-3 illustrate an
`embodiment of the graft of this invention as shown in the
`relaxed state. The graft 10 is generally a thin walled hollow
`cylinder having a first open end 12 and a second open end
`14. The graft is divided into ends portion 16 and 18 adjacent
`open ends 12 and 14 respectively, with central portion 20
`therebetween.
`As best viewed in FIG. 2, the end portion 18 is provided 10
`with a series of longitudinally extending pleats or crimps
`each comprised of a ridge 22 and a trough 24. End portion
`16, likewise is comprised of such crimps. The crimps
`thereby provide the end portion with a great degree of
`freedom in expanding the end portion to a selected diameter. 15
`The preferred geometry of the crimp may best be described
`in terms of the height of the crimp or "amplitude" and the
`distance between heights or "frequency" parameters.
`The amplitude, shown in FIG. 2 as the dimension A, is
`expressed as a percentage of the trough diameter of the end 20
`portion in the relaxed state i.e., the diameter taken from
`trough to diametrically opposed trough. It is believed that a
`preferred value for the amplitude ranges from about three
`percent to almost twenty percent of the trough diameter and
`preferably from about five percent to about fifteen percent of 25
`the trough diameter. Thus, for example, when trough diam(cid:173)
`eters, as may be typically employed, range from 26 to 30
`mm at the end portion of the graft, the height of the crimps
`or amplitudes may vary from about 0.78 mm to 6 mm and
`preferably, from about 1.3 mm to about 4.5 mm e.g., for 3 0
`example, a trough amplitude of 2 mm.
`The frequency, shown in FIG. 2 as the dimension F, is
`expressed as the distance between ridges 22 when the end
`portions are in the relaxed state. It is believed that preferred
`values for the frequency range from about 0.3 mm to about 35
`5 mm and preferably from about 1 mm to about 3 mm.
`When adhering to the broadest range of the above
`described parameters, the circumference of the graft at the
`end portions may be increased from a range of 10 to 300 %
`of the trough circumference (i.e., the circumference of the
`circle comprising the bottom of the troughs on the outer
`surface of the graft). Accordingly, the doctor when employ(cid:173)
`ing a balloon expanded stent to affix the graft will have a
`wide and, for practical purposes, an infinite degree of
`freedom in expanding to a diameter which will best suit the
`particular site of afiSxation.
`As best viewed in FIG. 3, the central portion 20 is
`provided with a series of circumferential crimps each of
`which are comprised of a ridge 26 and a trough 28. These 50
`crimps thereby provide the central portion with a great
`degree of freedom in extending the central portion to a
`selected length to conform to the site of application. Again
`the geometry of these circumferential crimps is best
`described in terms of the height of the crimp or "amplitude"
`and the distance between heights or "frequency" parameters.
`The amplitude for the central portion, shown in FIG. 3 as
`the dimension A', is again expressed as a percentage of the
`trough diameter of the central portion in the relaxed state and
`may vary through essentially the same range of values as for
`the end portions i.e., from about three to twenty percent and 60
`preferably from about five to fifteen percent. Similarly, the
`frequency, shown in FIG. 3 as the dimension F , is expressed
`as the distance between ridges 26 when the central portion
`is in the relaxed state. Again it is believed that preferred
`values for the frequency in the central portion may range 65
`from about 0.3 mm to about 5 mm and preferably from about
`1 mm to about 3 mm.
`
`55
`
`.,
`
`When adhering to the above parameters, the central
`portion may be expanded in length, from about 10 to about
`200 percent, based on the length of the crimped central
`portion in its unexpanded state. Accordingly the doctor,
`employing a single sized graft, may accommodate a wide
`variety of grafting applications.
`It should be understood that while the exemplified
`embodiment has been illustrated with specific geometry, a
`wide variation is possible within the broad teachings of this
`invention. For example, while the crimps in the central
`portions and in the end portions have been illustrated as
`having uniform amplitude and frequency,
`in certain
`instances it may be preferable to vary these parameters
`within a given portion or even to omit crimping in certain
`sections of a given portion.
`As best illustrated in FIGS. 1 and 3, the end portions 16
`and 18 of the graft 10 have greater diameters in the relaxed
`state than the central portion 20, thereby imparting the graft
`with a somewhat dumbbell-like shape. Such a shape is
`preferable in that it most closely resembles the shape of the
`lumen in the grafted section of a diseased blood vessel (i.e.,
`the section comprising the healthy portions of the vessel and
`the diseased portion there between) and hence avoids kinks
`and folds which would otherwise occur in a graft of uniform
`diameter as it conforms to the lumen of the blood vessel.
`Referring to FIG. 4, illustrated therein is an emplaced
`graft 10 of this invention in a blood vessel 30. As illustrated,
`the end portion 16 and 18 are employed, respectively, in
`healthy sections 32 and 34 of the vessel 30 and the stents 36
`and 38 expanded to sandwich the walls of the end portions
`16 and 18 between the stents and the vessel walls so as to
`affix the graft in place. As is typical, the diseased portion 36
`of vessel 30 displays an aneurysm i.e., a weakened,
`expanded wall. Additionally, as shown, the space between
`the graft and the aneurysm wall is filled with a gel-like clot,
`known as mural thrombus, which greatly decreases the
`lumen size in the diseased portion of the vessel as contrasted
`to the lumen size in the healthy portion. Accordingly, if the
`central portion of the graft is sized to have the same diameter
`as the end portions, when the central portion is emplaced, in
`order to conform to the reduced lumen size, the central
`portion must undesirably kink or fold. However, in accor(cid:173)
`dance with the teachings herein, because of the dumbbell(cid:173)
`like shape of the preferred graft of this invention, such
`kinking and folding is avoided.
`
`Referring back to FIG. 3, the geometrical parameters
`relating to the preformed dumbbell shape are best described
`in terms of the ratio of the largest ridge diameter of the
`largest end portion (D in FIG. 3) to the smallest ridge
`diameter of the central portion (D' in FIG. 3), wherein ridge
`diameter is the distance between the outer surface of a ridge
`to the outer surface of its diametrically opposed ridge (it
`should be noted that the end portions need not have the same
`ridge diameter and that the diameter within either end
`portion or the central portion does not necessarily have to be
`uniform). It is believed that this ratio may vary from about
`1.1 to about 4 and preferably from about 1.2 to about 1.4.
`Thus, for example, for a central portion ridge diameter of 22
`mm, the end ridge diameter preferably may vary from about
`24 to about 30 mm.
`Referring to FIGS. Sa-Sd and FIGS. 6a and 6b, illustrated
`therein schematically is the graft of this invention mounted
`on a double balloon catheter 40 and the method of employ(cid:173)
`ing the graft. As best seen in the right hand portion of FIG.
`Sd, the catheter 40 comprises a hollow tube 42 having a
`lumen therethrough 44. Affixed to the catheter tube 42 are
`
`Edwards Lifesciences Corporation, et al. Exhibit 1134, Page 7 of 9
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`5,476,506
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`two expansion balloons 46 and 48. The balloons are capable
`of being expanded by the action of introducing, under
`pressure, an expanding fluid such as air or water from a
`remote source and being deflated by depressuring such fluid.
`The means for so introducing fluid remotely through the
`catheter to the balloons are well known in the art of
`angioplasty balloon catheters and stent delivery systems and
`hence are not illustrated in the drawings for the sake of
`simplicity.
`As illustrated in FIGS. 6a and 6b, each end portion of the
`graft 10 (crimping omitted for clarity) is affixed to an
`expandable stent 50 by such means as suturing or employing
`an adhesive, staples, barbs, pins, or the like. Because the
`graft diameter is substantially larger than the unexpanded
`stent 50, it is desirable to fold the end portions of the graft
`51, 53 about the stent 50 (and consequently fold the central
`portion 20 about the catheter). Such folding is illustrated in
`FIG. 6b wherein the projecting ends of the graft 51, 53 are
`first folded flat (FIG. 6a) and then wrapped about the stent
`50 (and about the catheter in the central portion) in an
`s-shaped configuration (FIG. 6b). This folding greatly facili(cid:173)
`tates the unfolding of the graft upon expansion so as to be
`free of kinks and folds when emplaced.
`Referring to FIG. 5A, the graft, with its end portions 16
`and 18 affixed to stents 50 and 52, is folded as illustrated in
`FIG. 6b and is mounted on the catheter 40. Stent 50 is
`mounted on the unexpanded balloon 48 and stent 52 is
`mounted on the unexpanded balloon 46 with the central
`portion 20 of the graft folded about the catheter. The
`catheter, with the mounted stent-graft assembly, is then
`introduced into the body of the patient as, for example,
`through the femoral artery. The catheter is manipulated
`through the vascular system of the patient until the lead
`balloon 48 is in the correct position e.g., the cranial healthy
`portion of a diseased aorta. The doctor then expands the
`balloon 48, which in turn expands the stent 50 and the
`leading end portion 16 of the graft as illustrated in FIG. 5b.
`Because of the longitudinal crimps provided in such end
`portion 16 the doctor has the freedom to expand this end
`portion to precisely the degree required to trap and affix the
`walls of the graft between the walls of the cranial healthy
`portion of the vessel (not shown) and the stent.
`Next, with the expanded stent 50 and the end portion 16
`firmly affixed, the doctor deflates the balloon 48 and extends
`the central portion 20 of the graft proximally to locate the
`balloon 46 and its associated stent 52 and end portion 18 in
`the desired position on the caudal healthy portion of the
`vessel. Because of the circumferential crimps provided in
`the central portion, the doctor has the freedom to locate end
`portion 18 in precisely the desired position. The balloon 46
`is then expanded to expand stent 52 and trap and affix end
`portion 18 between the expanded stent 52 and the wall of the
`caudal healthy portion of the vessel (also not shown). This
`step is illustrated in FIG. 5c.
`Finally, the doctor deflates balloon 46 and removes the
`catheter from the patient, leaving graft 10 in place as is
`illustrated in FIG. 5d.
`The graft of this invention may be constructed of a variety
`of materials such as are now employed for vascular grafts.
`Such materials may be in the form of films and yams, woven
`or knitted into hollow cylinders, and employing such natu(cid:173)
`rally occurring polymers such as cellulose or silk. Addition(cid:173)
`ally synthetic polymers such as polyolefins e.g. polyethyl(cid:173)
`ene, polypropylene; polyethylene
`terephthalate; nylon;
`polytetrafluoroethylene or polyurethene may be employed.
`In addition to weaving or knitting yams into cylinders, the
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`cylinders may be formed by other methods known in the art
`such as by molding or extrusion. The crimping may be
`introduced by molding about an appropriately shaped mold
`or by first forming an uncrimped cylinder and then shrinking
`the cylinder about an appropriately shaped mandrel. Woven,
`knitted or otherwise shaped cylinders may be shrunk in such
`manner about a mandrel by means of heat shrinking, chemi(cid:173)
`cal shrinking means or by a combination of heat and water.
`The material of choice is polyethylene terephthalate which
`is woven into a cylinder having the requisite dumbbell
`shape. The central portion is then shrunk about a mandrel to
`introduce the circumferential crimp. Appropriate mandrels
`are then inserted into the end portion which are then shrunk
`to introduce the longitudinal crimps and the finished graft is
`then removed from the mandrels which may come apart for
`ease in removal.
`What is claimed is:
`1. A tubular graft for a body passageway comprising a
`longitudinally extending thin walled hollow cylinder having
`first and second open ends, first and second end portions
`adjacent said first and second open ends, respectively, and a
`central portion longitudinally extending between said end
`portions;
`the walls having circumferential crimps solely in said
`central portion and longitudinally extending crimps
`solely in said end portions;
`whereby said central portion can be extended longitudi(cid:173)
`nally from its relaxed position to vary the distance
`between the end portions and the end portions can be
`extended radially to vary the diameter of said end
`portions.
`2. The graft of claim 1 wherein said crimps in said
`portions each comprise a ridge and a trough defining an
`amplitude, a frequency, a trough diameter and a ridge
`diameter.
`3. The graft of claim 2 wherein the amplitude of the crimp
`in at least one said end portion, in the relaxed state ranges
`from about three percent to about twenty percent of the
`trough diameter of said crimps.
`4. The graft of claim 3 wherein the amplitude of the crimp
`in said end portion in the relaxed state ranges from about five
`to about fifteen percent of the trough diameter of said
`crimps.
`5. The graft of claim 2 wherein the frequency of the
`crimps in at least one of said end portions, in the relaxed
`state, ranges from about 0.3 mm to about 5 mm.
`6. The graft of claim 5 wherein the frequency of the
`crimps in at least one of said end portions, in the relaxed
`state, ranges from about 1 mm to about 3 mm.
`7. The graft of claim 2 wherein the amplitude of the
`crimps in at least one said end portion, in the relaxed state,
`ranges from about three percent to about twenty percent of
`the trough diameter of said crimp and the frequency of the
`crimps of said end portion, in the relaxed state, ranges from
`about 0.3 mm to about 5 mm.
`8. The graft of claim 2 wherein the amplitude of the
`crimps in the central portion, in the relaxed state, ranges
`from about three to about twenty percent of the trough
`diameter of said crimps.
`9. The graft of claim 8 wherein the amplitude of the
`crimps in the central portion, in the relaxed state, ranges
`from about five to about fifteen percent of the trough
`diameter of said crimps.
`10. The graft of claim 2 wherein the frequency of the
`crimps in the central portion, in the relaxed state, ranges
`from about 0.3 mm to about 5 mm.
`
`50
`
`55
`
`60
`
`65
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`10
`
`15
`
`11. The graft of claim 10 wherein the frequency of the
`crimps in the central portion, in the relaxed state, ranges
`from about 1 mm to about 3 mm.
`12. The graft of claim 2 wherein the amplitude of the
`crimps in the central portion, in the relaxed state, ranges
`from about three to about twenty percent of the trough
`diameter of said crimp and the frequency of the crimps in the
`central portion, in the relaxed state, ranges from about 0.3
`mm to about 5 mm.
`13. The graft of claim 2 wherein the crimps in at least one
`said end portion and the crimps in said central portion, in the
`relaxed state, have an amplitude ranging from about three
`percent to about twenty percent of the trough diameter of
`said crimps and a frequency, in the relaxed state, ranging
`from about 0.3 to about 5 mm.
`14. The graft of claim 2 wherein, in the relaxed state, the
`end portions of the graft each comprises crimps having
`greater ridge diameter than the smallest ridge diameter of
`crimps in the central portion.
`15. The graft of claim 14 wherein the ratio of said greater 20
`ridge diameter to said smallest ridge diameter ranges from
`about 1.4 to about 4.
`16. The graft of claim 15 wherein the ratio of said greater
`ridge diameter to said smallest ridge diameter range from
`about 1.2 to about 1.4.
`17. The graft of claim 1 wherein at least one said end
`portion is mounted over an expandable stent.
`18. The graft of claim 17 wherein both end portions are
`each mounted over separate expandable stents.
`19. The graft of claim 17 wherein said graft and expand(cid:173)
`able stent are mounted over a balloon catheter with said
`expandable stent mounted over the balloon.
`20. The graft of claim 18 wherein said graft and expand(cid:173)
`able stents are mounted over a double balloon catheter with
`
`25
`
`30
`
`8
`each of said expandable stent mounted over a balloon of said
`catheter.
`21. A tubular graft for a body passageway comprising
`longitudinally extending thin walled hollow cylinder having
`first and second open ends, first and second end portions
`adjacent said first and second open ends, respectively, and a
`central portion longitudinally extending between said end
`portions;
`the walls of said central portion having circumferential
`crimps and said end portions having longitudinally
`extending crimps, said crimps in said central and end
`portions each comprising a ridge and a trough defining
`an amplitude, a frequency, a trough diameter and a
`ridge diameter;
`the amplitude of the crimps in at least one of said end
`portions, in the relaxed state, ranging from about three
`percent to about twenty percent of the trough diameter
`of said crimp in said end portions and the frequency of
`the crimp in said end portion, in the relaxed state,
`ranging from about 0.3 to about 5 mm;
`the amplitude of the crimp in the central portion, in the
`relaxed state, ranging from about three percent to about
`twenty percent of the trough diameter of said crimp in
`said central portion and the frequency of the crimp in
`said central portion in the relaxed state ranging from
`about 0.3 to about 5 mm;
`wherein, in the relaxed state, the end portions of the graft
`each comprise crimps having a greater ridge diameter
`than the smallest ridge diameter of crimps in the central
`portion and wherein the ratio of said greater ridge
`diameter to said smallest ridge diameter ranges from
`about 1.4 to about 4.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1134, Page 9 of 9
`
`