I 1111111111111111 11111 1111111111 1111111111 1111111111 11111 111111111111111111
`US007025780B2
`
`c12) United States Patent
`Gabbay
`
`(IO) Patent No.:
`(45) Date of Patent:
`
`US 7,025,780 B2
`Apr. 11, 2006
`
`(54) VALVULAR PROSTHESIS
`
`(56)
`
`References Cited
`
`(76)
`
`Inventor: Shlomo Gabbay, #1 Randall Dr., Short
`Hills, NJ (US) 07078
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 213 days.
`
`(21) Appl. No.: 10/373,138
`
`(22) Filed:
`
`Feb. 24, 2003
`
`(65)
`
`Prior Publication Data
`
`US 2003/0149477 Al
`
`Aug. 7, 2003
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 09/659,882, filed on
`Sep. 12, 2000, now abandoned.
`
`(51)
`
`Int. Cl.
`A61F 2124
`(2006.01)
`(52) U.S. Cl. ..................... 623/2.13; 623/2.17; 623/900
`( 58) Field of Classification Search ... ... ... ... .. . 623/1.24,
`623/1.26, 2.14, 2.15, 2.16, 2.17, 2.18, 2.19,
`623/900
`See application file for complete search history.
`
`U.S. PATENT DOCUMENTS
`
`5,855,597 A
`5,855,601 A *
`5,935,163 A *
`6,425,916 Bl *
`2001/0020181 Al
`2001/0021872 Al
`
`1/1999 Jayaraman ................. 623/1.16
`1/1999 Bessler et al. .............. 623/900
`8/1999 Gabbay ..................... 623/2.14
`7/2002 Garrison et al. ........... 623/1.26
`9/2001 Layne
`9/2001 Bailey et al.
`
`OTHER PUBLICATIONS
`
`Ross D., Pulmonary valve autotransplantation (the Ross
`operation), Sep. 1988, J. Cardiac Surgery, 3:313-9.*
`
`* cited by examiner
`
`Primary Examiner-Brian E. Pellegrino
`(7 4) Attorney, Agent, or Firm-Tarolli, Sundheim, Covell &
`Tummino L.L.P.
`
`(57)
`
`ABSTRACT
`
`A valvular prosthesis and method of using the prosthesis are
`disclosed. A valve apparatus is located within a stent appa(cid:173)
`ratus, such that the prosthesis is deformable between a first
`condition and a second condition, in which the prosthesis
`has a reduced cross-sectional dimension relative to the first
`condition, whereby implantation of the prosthesis is facili(cid:173)
`tated when in the second condition.
`
`6 Claims, 5 Drawing Sheets
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 1 of 13
`
`

`

`U.S. Patent
`
`Apr. 11, 2006
`
`Sheet 1 of 5
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`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 2 of 13
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`

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`U.S. Patent
`
`Apr. 11, 2006
`
`Sheet 2 of 5
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`US 7,025,780 B2
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`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 3 of 13
`
`

`

`U.S. Patent
`
`Apr. 11, 2006
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 4 of 13
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`

`

`U.S. Patent
`
`Apr. 11, 2006
`
`Sheet 4 of 5
`
`US 7,025,780 B2
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`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 5 of 13
`
`

`

`U.S. Patent
`
`Apr. 11, 2006
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 6 of 13
`
`

`

`US 7,025,780 B2
`
`1
`VALVULAR PROSTHESIS
`
`RELATED APPLICATION
`
`This application is a continuation of U.S. patent applica-
`tion Ser. No. 09/659,882, which was filed on Sep. 12, 2000,
`now abandoned and entitled VALVULAR PROSTHESIS
`AND METHOD OF USING SAME, which is incorporated
`herein by reference.
`
`TECHNICAL FIELD
`
`The present invention relates to an implantable prosthetic
`device and, more particularly, to a valvular prosthesis and to
`a method of using the prosthesis.
`
`5
`
`2
`valve can then be permitted to expand from the reduced
`cross-sectional dimension to the expanded cross-sectional
`dimension such as to replace an insufficient heart valve or an
`insufficient venous valve.
`In accordance with one aspect, the stented valve may be
`deformed to the reduced cross-sectional dimension by place(cid:173)
`ment within a retaining mechanism, such as a generally
`cylindrical enclosure of a catheter apparatus. The enclosure
`may be employed to position the stented valve at a desired
`10 position and then discharge the prosthesis from the enclo(cid:173)
`sure. The stented valve then expands toward the expanded
`cross-sectional dimension and at least a portion of the outer
`surface of the stent engages surrounding tissue to inhibit
`axial movement of the stented valve relative to the surround-
`15 ing tissue.
`
`BACKGROUND
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`It is well known to utilize mechanical heart valves, such
`as the ball check valve, and natural tissue cardiac valves to 20
`replace defective aortic and mitral valves in human patients.
`One type of natural tissue heart valve typically employs a
`porcine valve for implantation in a human, as they are very
`similar to human valves of appropriate size and generally are
`easy to procure. Typically, the porcine valve is fixed by 25
`chemically treating it, such as with an appropriate glutaral(cid:173)
`dehyde solution. The treated porcine valve further may be
`mounted into a stent to support the valve at a fixed position.
`A stent typically is formed of a resilient material, such as
`a plastic ( e.g., DELRIN). Examples of various stent struc- 30
`tures are disclosed in U.S. Pat. No. 3,983,581, U.S. Pat. No.
`4,035,849. The stent usually is covered with a fabric mate(cid:173)
`rial, such as DACRON or a suitable textile material. The
`fabric material provides structure for securing the valve
`relative to the stent. The stented heart valve prosthesis may 35
`be implanted into a patient for a heart valve replacement.
`In order to surgically implant a heart valve into a patient,
`the patient typically is placed on cardiopulmonary bypass
`during a complicated, but common, open chest procedure. In
`certain situations, an individual requiring a heart valve 40
`replacement may be sufficiently ill, such that placing the
`individual on cardiopulmonary bypass may pose too great a
`risk. Such individuals may correspond to a class of patients
`who may have a non-functioning pulmonary valve or severe
`aortic valve insufficiency. In particular, older patients having 45
`a deficient aortic valve may be too ill to survive conventional
`open-heart surgery.
`Another class of individuals may be suffering from vas(cid:173)
`cular degeneration associated with the lower extremities.
`Such degeneration may include inoperative or otherwise 50
`ineffective venous valves resulting in one or more undesir(cid:173)
`able indications.
`These and other conditions would benefit from an
`improved valvular prosthesis that may be implanted by a
`less invasive and/or less time-consuming implantation pro(cid:173)
`cedure.
`
`SUMMARY
`
`To the accomplishment of the foregoing and related ends,
`certain illustrative aspects of the invention are described
`herein in connection with the following description and the
`annexed drawings. These aspects are indicative, however, of
`but a few of the various ways in which the principles of the
`invention may be employed and the present invention is
`intended to include all such aspects and their equivalents.
`Other advantages and novel features of the invention will
`become apparent from the following detailed description of
`the invention when considered in conjunction with the
`drawings, in which:
`FIG. 1 is an exploded isometric view of a valve and stent
`apparatus that may be utilized to form a prosthesis in
`accordance with the present invention;
`FIG. lAin enlarged view of part of the stent ofFIG.1 in
`a first condition;
`FIG. lB is enlarged view of part of the stent of FIG. 1,
`similar to FIG. lA, illustrating the part of the stent in a
`second condition;
`FIG. 2 is an example of a valvular prosthesis in accor(cid:173)
`dance with the present invention;
`FIG. 3 is another example of valvular prostheses in
`accordance with the present invention;
`FIG. 4 is an example of the valvular prostheses of FIG. 3
`implanted within a tubular member in accordance with the
`present invention;
`FIG. 5 is another example of a stent apparatus in accor(cid:173)
`dance with the present invention;
`FIG. 6A is an example of the stent of FIG. 5 mounted
`within an enclosure in accordance with the present inven(cid:173)
`tion;
`FIG. 6B is an example of valvular prostheses having the
`stent of FIG. 5 mounted therein in accordance with the
`present invention;
`FIG. 7 is an example of a valvular prosthesis, illustrating
`an outer sheath over the prosthesis of FIG. 6B in accordance
`55 with the present invention;
`FIG. 8 another example of a valvular prosthesis, illustrat(cid:173)
`ing an outer sheath over the prosthesis of FIG. 6B in
`accordance with the present invention;
`FIG. 9A is an example of enclosure that may be utilized
`60 for implanting a valvular prosthesis in accordance with the
`present invention;
`FIG. 9B is an example of another enclosure catheter
`mechanism that may be utilized for implanting a valvular
`prosthesis in accordance with the present invention;
`FIG. 10 is an example of a valvular prostheses implanted
`in an aortic position of a heart in accordance with the present
`invention; and
`
`The present invention relates to a valvular prosthesis
`operable to mitigate valvular insufficiency. The prosthesis
`includes a valve apparatus located within a stent apparatus
`to form a stented valve. The stented valve is deformable
`between reduced and expanded cross-sectional dimensions.
`For example, the stented valve may be deformed to the 65
`reduced cross-sectional dimension to facilitate positioning
`the stented valve to a desired implantation position. The
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 7 of 13
`
`

`

`US 7,025,780 B2
`
`3
`FIG. 11 is an example of a valvular prostheses implanted
`in a pulmonic position of a heart in accordance with the
`present invention.
`
`DESCRIPTION OF THE INVENTION
`
`FIG. 1 is an exploded view of a valvular prosthesis 10 in
`accordance with an aspect of the present invention. The
`prosthesis 10 includes a valve portion 12 and a stent portion
`14 that may be assembled to form the valvular prosthesis 10,
`such as shown in FIG. 2.
`The valve portion 12 includes inflow and outflow ends 16
`and 18 spaced apart from each other by a length of a
`generally cylindrical sidewall portion 20. While the inflow
`and outflow ends 16 and 18 are illustrated as being annular 15
`in FIGS. 1 and 2, those skilled in the art will understand and
`appreciate that other configurations (e.g., generally sinusoi(cid:173)
`dal ends) also could be used in accordance with the present
`invention.
`The valve portion 12 also includes one or more leaflets 22,
`24, and 26 that are attached to and extend from an interior
`of the sidewall portion 20. In the example illustrated in
`FIGS. 1 and 2, the valve portion 12 includes three leaflets 22,
`24 and 26, although other numbers of leaflets, such as a
`single leaflet or two leaflets, also could be used.
`The valve portion 12 may be formed of any substantially
`biocompatible valve apparatus. By way of example, the
`valve portion 12 may include an animal heart valve ( e.g.,
`pulmonic or aortic), a manufactured valve device (e.g., a
`valve as shown and described in U.S. Pat. No. 4,759,758 or
`U.S. Pat. No. 5,935,163) a venous valve (e.g., a bovine or
`equine jugular venous valve). Those skilled in the art will
`understand and appreciate that the foregoing list is not
`intended to be exhaustive but, instead, is intended illustrate
`a few examples of the types of valves that may be utilized
`in a valvular prosthesis 10 in accordance with an aspect of
`the present invention.
`If the valve portion 12 is formed of a natural tissue
`material, such as an animal heart valve, a venous valve, or
`a composite valve manufactured of natural tissue, the valve
`should be chemically fixed, such as in a suitable solution of
`glutaraldehyde in a closed condition (as is known in the art).
`The fixation process facilitates closure of the valve 12 under
`application of back flow pressure, while remaining open
`during normal forward blood flow through the valve 12. By
`way of example, the natural tissue valve may be cross-linked
`with glutaraldehyde and undergo a detoxification process
`with heparin bonding, such as according to a NO-REACT®
`treatment process from Shelhigh, Inc. of Millburn, N.J. The
`NO-REACT® treatment improves biocompatibility of the
`valve apparatus 12 and mitigates calcification and thrombus
`formation.
`In accordance with an aspect of the present invention, the
`valve portion 12 exhibits structural memory. That is, if the
`valve apparatus 12 is compressed, such as to a reduced
`diameter at the time of being implanted, it will return
`substantially to its original shape and configuration upon
`removal of radially inward forces. As a result, the valve
`apparatus 12 is able to maintain coaptation of the leaflets 22,
`24, and 26 even after being deformed. The memory feature
`of the valve is further improved by mounting it within the
`stent portion 14.
`Turning now to the stent portion 14, such as shown in
`FIGS. 1 and 2, the stent includes an inflow end 30 and an
`outflow end 32. In this example, the inflow and outflow ends 65
`30 and 32 are spaced apart from each other a distance that
`is greater than the distance between the corresponding ends
`
`4
`18 and 16 of the valve 12. In this way, the ends of the stent
`30 and 32 may extend beyond the respective ends 18 and 16
`of the valve 12 ( e.g., by about a few millimeters), such as
`shown in FIG. 2. The stent portion 14 also may include
`5 outwardly turned portions at the inflow and outflow ends 30
`and 32 of the stent, which, when implanted, may engage
`and/or be urged into the surrounding tissue to mitigate
`movement thereof.
`According to an aspect of the present invention, the stent
`10 14 may deformable between first and second conditions, in
`which the first condition has a reduced cross-sectional
`dimension relative to the second condition. FIGS. 1 and 2
`illustrate the stent portion 14 as being formed of a mesh or
`weave 34 extending between the ends 30 and 32. The mesh
`34 may be a metal, an alloy, or other suitable material that
`may help support a valve mounted therein and/or help
`anchor the valve at a desired position when implanted.
`By way of example, the mesh may be formed of a shape
`memory alloy material, such as may be formed of a nitinol
`20 (nickel-titanium alloy) wire. Shape memory (or thermal
`memory) is a characteristic in which a deformed part
`remembers and recovers to a pre-deformed shape upon
`heating. By forming the stent 14 of a shape memory alloy,
`the stent is inelastically deformable to new shape, such as a
`25 reduced cross-sectional dimension, when in its low-tempera(cid:173)
`ture (martensitic) form. For example, the stented valve (FIG.
`2) may be cooled, such as by being introduced to a cooling
`solution (e.g., water), and then compressed.
`When the stent 14 is heated to its transformation tem-
`30 perature, which may vary according to the alloy composi(cid:173)
`tion, it quickly reverts to its high-temperature (austenitic)
`form. The stented valve may retain the compressed condi(cid:173)
`tion by keeping it cooled. Alternatively, the stent and valve
`may be retained in the compressed position, such as with
`35 sutures circumscribing the structure, a cylindrical enclosure
`around the structure, etc. The prosthesis 10 will then return
`toward its high-temperature (or original) position upon
`removal of the retaining element.
`It is to be appreciated that, alternatively, the stent 14, in
`40 accordance with an aspect of the present invention, could be
`inelastically deformable so as to require an intervening force
`to return the deformed stent substantially to a desired
`configuration. For example, a balloon catheter or spring
`mechanism could be employed to urge the stent and the
`45 valve located therein generally radially outward so that, after
`being implanted to a desired position, the stent will engage
`the surrounding tissue in a manner to inhibit movement
`relative to the surrounding tissue.
`FIGS. lA and lB illustrate an enlarged view of part of the
`50 stent 14 in accordance with an aspect of the present inven(cid:173)
`tion. In this example, some strands of the mesh 34 are
`broken to define spaces 36 between adjacent lateral exten(cid:173)
`sions or spike portions 38 and 40. As the stent 14 is
`deformed, such as shown in FIG. lB, the spike portions 38'
`55 and 40' may extend radially outwardly from the stent in
`different directions. In addition, the inflow end 32' also may
`flare outwardly for engagement with surrounding tissue
`when implanted. For example, some spikes 40, 40' may
`extend generally outwardly and toward an outflow end of the
`60 stent 14, while others 38, 38' may extend generally out(cid:173)
`wardly and toward an inflow end 3 2, 3 2'. The spikes thus are
`operable to engage tissue, when implanted, so as to inhibit
`axial movement of the stent 14 relative to the surrounding
`tissue.
`Referring back to FIG. 2, the valve portion 12 is disposed
`generally coaxially within the cylindrical stent portion 14
`relative to the central axis A. The valve 12 may be affixed
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 8 of 13
`
`

`

`US 7,025,780 B2
`
`5
`relative to the stent portion 14, such as by one or more
`sutures 44. The sutures 44 may be located at the inflow and
`outflow ends 16 and 18 of the valve 12 to connect the valve
`to the stent 14 to inhibit axial movement of the valve relative
`to the stent. Alternatively or additionally, axial movement
`between the stent 14 and valve 12 may be mitigated due to
`friction fitting between the stent and valve portion. For
`example, as illustrated in FIG. 2, the valve portion 12 has a
`cross-sectional diameter that is slightly larger than that of the
`stent 14, such that the prosthesis 10 bulges somewhat in the 10
`middle and is narrower near the inflow and outflows ends 16
`and 18 of the valve portion 12.
`As mentioned above, the stent portion 14 may be formed
`of a shape memory alloy. In this way, the valvular prosthesis
`10 may be compressed to a reduced cross-sectional dimen- 15
`sion about the axis A and maintained at the reduced dimen-
`sion while being implanted. Once the valvular prosthesis 10
`is at a desired implantation position, the prosthesis may be
`permitted to return toward its original cross-sectional dimen(cid:173)
`sion so as to engage a valve wall or other surrounding tissue
`at the desired position. The engagement between the stented
`valvular prosthesis 10 and the surrounding tissue inhibits
`axial movement of the prosthesis relative to the tissue. In
`accordance with an aspect of the present invention, lateral
`extensions or spikes (see, e.g., FIGS. lA and 1B) may 25
`extend outwardly from the stent to further inhibit axial
`movement. Those skilled in the art will understand and
`appreciate that a valvular prosthesis 10, in accordance with
`the present invention, may be utilized to replace a heart
`valve or utilized as an intravascular implant to provide an
`operable venous valve.
`FIG. 3 illustrates another example of a stented valvular
`prosthesis 50 in accordance with an aspect of the present
`invention. The prosthesis 50 in this example includes a valve
`portion 52 mounted within a stent portion 54. The valve
`portion 52 in this example, has a generally sinusoidal
`outflow end 56 having a plurality of commissure posts 58,
`60, and 62 extending from an annular base portion 64, with
`corresponding sinuses located between each adjacent pair of
`posts. It is to be appreciated that, alternatively, a valve 40
`having a sidewall portion according to generally cylindrical
`configuration of FIGS. 1 and 2 also could be used in
`conjunction with the stent portion 54.
`The stent portion 54 in this example is formed of a
`deformable mesh, which may be substantially identical to 45
`that described above with respect to FIGS. 1-2. The stent
`portion 54 also includes a plurality of spikes extending
`generally radially outwardly from the stent portion. In
`particular, one set of spikes 66 extend from an inflow end 68
`of the stent portion 54 and another set of spikes 70 extend 50
`from an outflow end 72 of the stent.
`FIG. 4 illustrates the prosthesis 50 of FIG. 3 mounted in
`an expanded condition within a generally cylindrical side(cid:173)
`wall 74. The sidewall 74, for example, may be a venous
`valve wall, a pulmonary artery, an aorta, etc. In this example, 55
`the spikes 66 and 70 engage and/or extend into the valvular
`wall 74 to inhibit axial movement of the prosthesis 50
`relative to the valve wall 74.
`FIG. 5 illustrates another example of a stent apparatus 80
`which may be utilized as part of a valvular prosthesis in
`accordance with an aspect of the present invention. The stent
`80 includes a generally annular base portion 82 and a
`plurality of axially extending portions ( or stent posts) 84, 86
`and 88 extending generally axially from the base portion.
`The post portions 84, 86 and 88 are circumferentially spaced 65
`apart for generally radial alignment with corresponding
`commissure posts of an associated valve wall. While the
`
`6
`example of the stent 80 in FIG. 5 has three stent posts 84, 86
`and 88, those skilled in the art will understand and appre(cid:173)
`ciate that other numbers of posts also could be utilized in
`accordance with an aspect of the present invention. Typi-
`5 cally, however, the number of posts and their relative
`circumferential position correspond to the number ofleaflets
`of a valve to be mounted within the stent 80.
`In accordance with an aspect of the present invention,
`each of the stent posts 84, 86, 88 may extend radially
`outwardly an angle 8 relative to the axis A. By way of
`example, the angle 8 may range from about 10 to about 60
`degrees relative to a line drawn through the juncture of each
`post and the base 82 parallel to the central axis A. The
`outwardly extending posts 84, 86, and 88 facilitate engage(cid:173)
`ment between each respective post and surrounding tissue
`when implanted, as the posts (being resilient) tend to urge
`radially outwardly and into engagement with such tissue.
`The stent 80 also includes a plurality of spikes 90 and 92
`that extend radially outwardly from the stent. In particular,
`20 some outwardly extending spikes 90 are curved generally
`toward an outflow end of the stent and others 92 are curved
`generally toward an inflow end of the stent. In addition, a
`row of spikes 90 may extend outwardly relative to the stent
`80 at the inflow end thereof, which spikes also are curved
`generally toward the outflow end. The varying contour of the
`spikes 90 and 92 mitigates axial movement of the stent 80
`(in both axial directions) relative to tissue engaged thereby,
`such as after being implanted. It is to be understood and
`appreciated that, while a single row of spikes is illustrated
`30 near the inflow end of the stent in FIG. 5, two or more axially
`spaced apart rows of spikes extending generally radially
`outwardly from the stent 80 could also be utilized in
`accordance with an aspect of the present invention. The rows
`of spikes may be curved toward each other to provide a
`35 clamping function on surrounding tissue when implanted.
`FIG. 6A illustrates the stent of FIG. 5 mounted within a
`tubular structure 94 that has an inner diameter that is
`substantially commensurate with the outer diameter of the
`base portion 82 of the stent 80. The tubular structure 94 may
`be formed of a plastic or other material effective to hold the
`stent posts 84, 86, and 88 at a radial inward position. In this
`way, the tubular structure 94 urges the stent posts 84, 86, and
`88 radially inward to a position that facilitates mounting a
`valve 98 therein. For example, the valve 98 may be posi(cid:173)
`tioned within and connected to the stent 80, such as by
`sutures applied along the base portion 82 and the stent posts
`84, 86, and 88; without having to manually hold each of the
`posts against corresponding parts of the valve.
`FIG. 6B illustrates an example in which a valve 98 has
`been mounted within the stent 80 of FIG. 5 to form a
`valvular prosthesis 100. The valve 98 includes an inflow end
`102 and an outflow end 104. The inflow end 102 of the valve
`98 is positioned adjacent relative to the inflow end of the
`stent 80. The outflow end 104 of the valve 98 is contoured
`to include axially extending commissure posts 106, 108 and
`110 with sinuses 112, 114 and 116 located between each
`adjacent pair of posts. Valve leaflets 118, 120 and 122 extend
`between adjacent posts commensurate with the location of
`each of the sinuses 112, 114 and 116. The stent 80 may be
`60 connected to the valve 98 via sutures 124.
`In accordance with an aspect of the present invention, the
`prosthesis 100 of FIG. 6B is a stented valve, which may be
`covered with an outer sheath of a substantially biocompat(cid:173)
`ible material.
`FIG. 7 illustrates an example of a valvular prosthesis in
`which an outer sheath 130 has been applied over the stent 80
`and at least part of the exposed exterior portion of the valve
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 9 of 13
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`

`

`US 7,025,780 B2
`
`7
`98 in accordance with an aspect of the present invention. As
`illustrated, the outer sheath 130 may have inflow and out(cid:173)
`flow ends having generally the same contour as the sidewall
`of the valve 98 and the stent 80. The outer sheath 130 may
`be a sheath of natural tissue pericardium ( e.g., bovine, 5
`equine, porcine, etc.), another biological tissue material
`(e.g., collagen), or a synthetic material (e.g., Dacron). When
`a biological tissue is utilized, for example, it may be
`cross-linked with glutaraldehyde and detoxified with hep(cid:173)
`arin bonding, such as one of the NO-REACT® natural tissue 10
`products that are commercially available from Shelhigh, Inc.
`of Millburn, N.J.
`An implantation flange (or sewing ring) 132 may be
`formed at the inflow end of the prosthesis 100. The implan(cid:173)
`tation flange 132 may be formed of substantially the same 15
`material as the outer sheath 140, such as formed from the
`outer sheath 130 or by attaching a separate flange by other
`methods. The outer sheath 130 may be attached to the valve
`98 and/or to the stent 80 by applying sutures 134 and 136 at
`the respective inflow and outflow ends of the prosthesis 100. 20
`Some of the spikes 90, 92 may extend through the outer
`sheath 130 so as to mitigate axial movement of the pros(cid:173)
`thesis 100 relative to surrounding tissue when the prosthesis
`is implanted. Sutures 134 and 136 may be applied respec(cid:173)
`tively at the inflow and outflow ends to secure the outer 25
`sheath relative to the stent 80 and the valve 100. The outer
`sheath 130 may include an outflow end that conforms to the
`contour of the outflow end 104 of the valve 100.
`FIG. 8 illustrates another example of valvular prosthesis
`100 that is similar to that shown and described in FIG. 7, in
`which identical reference numbers refer to corresponding
`parts previously identified herein. The prosthesis 100
`includes having an outer sheath 140 that is disposed about
`the stent 80 and the valve 98 and having an outflow end that
`follows the contour of the prosthesis 100 (e.g., generally 35
`sinusoidal. In addition, the outer sheath 140 includes a
`plurality of axially extending lobes 142, 144 and 146 extend(cid:173)
`ing axially beyond the outflow attachment of the valve
`leaflets 118, 120, and 122. In this example, the lobes 142,
`144 and 146 extend axially a length beyond the commissure 40
`posts 106, 108 and 110 of the valve 98. The axially extend(cid:173)
`ing lobes 142, 144 and 146 provide additional structure that
`may be utilized to help secure the prosthesis 100 relative to
`surrounding tissue when being implanted. When the pros(cid:173)
`thesis 100 of FIG. 8 is implanted, for example, sutures may 45
`be applied through the lobes 142, 144 and 146 to help secure
`the commissure posts of the prosthesis relative to the sur(cid:173)
`rounding tissue. Additional sutures also could be applied at
`the inflow end to the implantation flange 132 located thereat.
`FIGS. 9A and 9B illustrate variations of an implantation 50
`apparatus 200 that may be utilized to implant a valvular
`prosthesis 202 in accordance with an aspect of the present
`invention. It is to be understood and appreciated that any of
`the prosthesis shown and/or described herein may be
`implanted with such an implantation apparatus.
`With reference to FIG. 9A, by way of example, the
`implantation apparatus 200 may be in the form of a catheter
`system. The implantation apparatus includes an elongated
`connecting element 204 extending between a trigger mecha(cid:173)
`nism 206 and an enclosure 208, in which the prosthesis 202 60
`is located. At least a portion of the prosthesis 202 is located
`within the enclosure 208. A plunger mechanism 210 is
`located at a proximal end of the enclosure 208 for urging the
`prosthesis 202 generally axially from the enclosure 208. An
`opposite end 212 of the enclosure 208 may be formed of a 65
`pliable material or a plurality of moveable members that
`may open as the prosthesis 202 is urged through an opening
`
`8
`214 located at a distal end. It is to be appreciated that the
`length of the connecting element 204 may vary according to
`where the valvular prosthesis 202 is to be implanted and the
`method of implantation.
`The valvular prosthesis 202 is illustrated within the enclo(cid:173)
`sure 208 in a compressed condition, such as described
`above. That is, the valvular prosthesis 202 within the enclo(cid:173)
`sure 208 has a cross-sectional dimension that is less than its
`normal cross-sectional dimension, being maintained in such
`position by the enclosure. Those skilled in the art will
`appreciate that the orientation of the valvular prosthesis 202
`will vary depending upon the direction in which blood is to
`flow through the valve when implanted.
`By way of example, the external stent of the valvular
`prosthesis 202 may be formed of a deformable material,
`such as a shape memory alloy material ( e.g., nitinol), which
`maintains its shape when cooled. Accordingly, the prosthesis
`202 may be cooled ( e.g., within a suitable fluid), compressed
`to a desired reduced cross-sectional dimension so as to fit
`within the enclosure 208, and then inserted within the
`enclosure. The prosthesis 202, after the stent being heated
`( e.g. to an ambient temperature), may desire to expand to its
`original dimension and configuration. However, the enclo(cid:173)
`sure 208 or another retaining mechanism, such as a suture or
`other tubular member around the prosthesis, may be used to
`restrict its expansion. The compression of the valvular
`prosthesis 202 may be performed just prior to surgery to
`mitigate undesired permanent deformation of the valvular
`prosthesis 202. The plunger mechanism may be urged in the
`30 direction of arrow 220, such as by activating the trigger 206.
`Movement of the plunger 210, in turn, causes the prosthesis
`202 to also be moved in the direction of the arrow 220. As
`the prosthesis 202 is urged through the opening 214 and
`discharged therefrom, the prosthesis may expand. Accord(cid:173)
`ingly, the opening 214 should be positioned at the location
`where the prosthesis 202 is to be implanted prior to dis-
`charge. When the prosthesis 202 expands toward its original
`condition, the sidewall of the stent and/or spikes associated
`with the stent may engage and/or be urged into surrounding
`tissue so as to mitigate axial movement of the prosthesis
`relative to the surrounding tissue. As a result, the prosthesis
`may be implanted without sutures to provide an operable
`valve, such as a heart valve or a venous valve. When a
`valvular prosthesis is being employed as a heart valve, in
`accordance with present invention, it will be appreciated that
`the prosthesis may be implanted either as part of an open
`chest procedure or the patient's chest may be closed. Addi(cid:173)
`tionally, other expandable stent structures also could be
`utilized in accordance with an aspect of the present inven(cid:173)
`tion.
`FIG. 9B illustrates another example of an enclosure 208
`which may be utilized, in accordance with an aspect of the
`present invention, to implant a prosthesis 202. The enclo