(12)
`
`United States Patent
`Eberhardt
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 6,350,282 B1
`*Feb. 26, 2002
`
`US006350282B1
`
`(54) STENTED BIOPROSTHETIC HEART VALVE
`
`(75) Inventor: Carol E. Eberhardt, Fullerton, CA
`(US)
`
`(73) Assignee: Medtronic, Inc., Minneapolis, MN
`(Us)
`
`(*) Notice:
`
`This patent issued on a continued pros-
`ecution application ?led under 37 CFR
`1.53(d), and is subject to the tWenty year
`patent term provisions of 35 U.S.C.
`154(21)(2)-
`_
`_
`_
`_
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(21) Appl' NO‘: 08/570’373
`(22) Filed;
`Dec_ 11, 1995
`
`Related US, Application Data
`
`(63) Continuation of application No. 08/231,603, ?led on Apr.
`22, 1994, now abandoned
`
`(51) Int. C].7 ................................................. .. A61F 2/24
`(52) US. Cl. .................................... .. 623/2.13; 623/2.14
`(58) Field of Search ......................... .. 623/2, 900, 2.13,
`623/214, 215, 216, 217, 218, 2,19
`
`(56)
`
`References Cited
`
`Us. PATENT DOCUMENTS
`
`3,365,728 A * 1/1968 Edwards et al. ............. .. 623/2
`4,035,849 A * 7/1977 Angell et al. ................ .. 623/2
`4,106,129 A * 8/1978 Carpentier et al. .......... .. 623/2
`4,345,340 A * 8/1982 Rosen ......................... .. 623/2
`4,451,936 A
`6/1984 Carpenter
`4,506,394 A * 3/1985 Bedard ........................ .. 623/2
`
`
`
`4,626,255 A * 12/1986 Reichart et al. 4,629,459 A * 12/1986 Ionescu et al. .............. .. 623/2
`
`4,692,164 A * 9/1987 Dzemeshkevich ........ .. 623/900
`4,816,029 A * 3/1989 Penny, III et al.
`5,037,434 A
`8/1991 Lane ........................... .. 623/2
`
`5,163,955 A * 11/1992 Love et a1. .................. .. 623/2
`5,258,021 A 11/1993 Duran ...... ..
`5,258,023 A * 11/1993 Regef ---- ~
`5,376,112 A * 12/1994 Duran ......................... .. 623/2
`
`FOREIGN PATENT DOCUMENTS
`2136533
`* 9/1984
`WO90/117738
`10/1990
`WO93/04643
`3/1993
`
`GB
`WO
`W0
`
`* cited by examiner
`
`Primary Examiner—Michael Milano
`(74) Attorney, Agent, or Firm—Thomas G. Berry; Daniel
`W_ Latham
`
`(57)
`
`ABSTRACT
`
`Asu orted bio rosthetic heart valve is rovided. The valve
`indulges a stent Iand a bilogical valve meIfnber. The stent has
`an annular frame de?ned by a support rail. The support rail
`is formed to de?ne a triad of axially-projecting
`circumferentially-spaced commissure posts, each post hav
`ing an inverted U-shaped con?guration and a pair of legs.
`Each of the pair of legs has an upper end and a loWer end.
`The loWer end of each leg merges smoothly With the loWer
`end of a leg of an adjacent commissure post. Asleeve having
`an in?ow end and an Out?ow end is ?tted around the annular
`frame. The biological valve member is de?ned by a tubular
`Wall and three lea?ets, the three lea?etsbeing attached to the
`tubular Wall and axially converging along three commis
`sures. The biological valve member has a shape Which ?ts
`the contour of the support rail and is disposed under the
`support rail. The biological valve member is sutured to the
`support rail and the out?oW end of the sleeve. The biopros
`thetic valve member also includes a suturing cuff Which is
`not rigidly attached to the support rail alloWing the valve to
`expand and contract in the lateral direction. The suturing
`cuff is formed by Wrapping the in?oW end of the sleeve
`around a ring-shaped cushion and suturing the sleeve to
`itself encapsulating thus the ring-shaped cushion. An in?oW
`support ring may also be provided Within the suturing cuff
`for added lateral support.
`
`17 Claims, 5 Drawing Sheets
`
`NORRED EXHIBIT 2313 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`Medtronic Corevalve, LLC
`v. Troy R. Norred, LLC
`Case IPR2014-00395
`
`

`
`U.S. Patent
`
`Feb. 26, 2002
`
`Sheet 1 0f 5
`
`US 6,350,282 B1
`
`FIG. 1
`
`FIG. 2
`
`NORRED EXHIBIT 2313 - Page 2
`
`

`
`U.S. Patent
`
`Feb. 26, 2002
`
`Sheet 2 0f 5
`
`US 6,350,282 B1
`
`FIG. 4
`
`NORRED EXHIBIT 2313 - Page 3
`
`

`
`U.S. Patent
`
`Feb. 26, 2002
`
`Sheet 3 0f 5
`
`US 6,350,282 B1
`
`FIG. 4A
`
`FIG. 4B
`
`NORRED EXHIBIT 2313 - Page 4
`
`

`
`U.S. Patent
`
`Feb. 26, 2002
`
`Sheet 4 0f 5
`
`US 6,350,282 B1
`
`FIG. 6
`
`NORRED EXHIBIT 2313 - Page 5
`
`

`
`U.S. Patent
`
`Feb. 26, 2002
`
`Sheet 5 0f 5
`
`US 6,350,282 B1
`
`ww
`
`wm
`
`b .UE
`
`NORRED EXHIBIT 2313 - Page 6
`
`

`
`US 6,350,282 B1
`
`1
`STENTED BIOPROSTHETIC HEART VALVE
`
`This application is a continuation of application Ser. No.
`08/231,603 ?led on Apr. 22, 1994, noW abandoned.
`
`FIELD OF THE INVENTION
`
`The present invention relates generally to arti?cial heart
`valves, and more particularly, is directed to a stented bio
`prosthetic heart valve.
`
`BACKGROUND OF THE INVENTION
`Diseased heart valves may either be repaired through
`surgical techniques or replaced With an arti?cial valve.
`Although reconstructive surgery has been shoWn to be
`superior to valve replacement, it is dif?cult to perform and
`is not alWays possible in every patient. The vast majority of
`patients have their valves replaced With arti?cial valves.
`There are tWo basic types of arti?cial valves. The ?rst type
`of arti?cial valve, called herein a “prosthetic” valve, is
`typically made of metal or a plastic material. The second
`type of arti?cial valve, called herein a “bioprosthetic” valve,
`comprises a prosthetic device and biological tissue. Both
`types of valves come in different shapes and diameters
`depending upon the particular valve being replaced (e.g.,
`mitral, aortic, tricuspid, or pulmonary) and the siZe of the
`individual patient’s heart. For example, a typical arti?cial
`aortic valve has an ori?ce opening of approximately 19—29
`mm in diameter and a typical arti?cial mitral valve has an
`ori?ce opening of 23—35 mm in diameter.
`The bioprosthetic valves comprise a biological valve
`member Which is typically an animal heart valve. The
`biological valve member is de?ned by a tubular Wall having
`an approximate thickness of 1.5 mm and three ?exible
`lea?ets integrally connected to the tubular Wall Which con
`verge axially along three commissures. The biological valve
`member may be a bovine pericardium or a porcine aortic
`valve Which is chemically treated. The porcine aortic valve
`is generally used for all valve replacements in the human
`heart. The siZe of the porcine aortic valve may vary,
`hoWever, depending on the type of valve being replaced in
`the patient (e.g., mitral, aortic, tricuspid, or pulmonary) and
`the siZe of the individual patient’s heart.
`Bioprosthetic valves are divided into tWo broadly de?ned
`classes. The ?rst class of bioprosthetic valves are stented
`having a frame (or stent) to Which the biological valve
`member is attached. The biological valve members are
`sutured to the stent Which provides support for the valve
`member in the patient’s body. The stent prevents the bio
`logical valve member from collapsing and simpli?es the
`insertion of the valve into the annulus of the patient after
`excision of the diseased valve. The stented bioprosthetic
`valves imitate the natural action of heart valves and provide
`a structure Which is relatively compatible With the cardio
`vascular system.
`The second class of bioprosthetic heart valves are stent
`less and thus do not have a frame. Rather, the biological
`valve member is sutured to a ?exible cloth material. The
`hemodynamics of a stentless valve more closely approxi
`mates that of a natural heart valve. AdraWback of a stentless
`valve, hoWever, is that it is more difficult to implant into the
`patient than a stented valve. Furthermore, a stentless valve
`can be collapsed and deformed by the action of the heart
`because it has no support structure. The action of the heart
`muscles on this type of valve can fold the valve material and
`create unexpected stress risers Which can eventually lead to
`failure.
`
`10
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`15
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`30
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`35
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`40
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`2
`The stented bioprosthetic valves are believed to have
`important clinical advantages over mechanical non-tissue
`prosthetic valves. Reports on the use of bioprosthetic valves
`indicate that the risks of thromboembolism are loWer, the
`need for long-term anticoagulation is minimiZed, and the
`nature of occasional valve failure is progressive, thereby
`permitting elective reoperation under optimal conditions.
`KnoWn stented bioprosthetic valves comprise a frame
`de?ned by a support rail Which is made of either a steel alloy
`or thermoplastic material, and a plastic Wall. The support rail
`has a circular cross-section and is formed to de?ne three
`commissure posts supporting the three lea?ets of the bio
`logical valve member. The plastic Wall conforms to the
`shape of the support rail de?ned by the three commissure
`posts providing a rigid support in the lateral direction. The
`support rails are typically ?exible, but not elastic, because
`the commissure posts are relatively rigid. As the valve
`lea?ets move from open to closed positions, bending
`stresses occur in the portion of the support rail connecting
`the commissures. HoWever, the commissure posts them
`selves do not bend signi?cantly.
`The frame is typically covered With a padded, gusseted
`and porous covering to facilitate attachment, tissue invasion,
`and encapsulation. A sleeve of porous biocompatible cloth is
`?tted about the frame and is loosely stitched thereto.
`Thereafter, a support ring having insert elements Which may
`be portions of a plastic Web is positioned outside of the
`sleeve betWeen each of the commissure posts. The sleeve is
`trimmed and secured by stitching to the margins of the insert
`elements. A covering of porous biocompatible cloth is then
`?tted about the stent, completely enclosing the frame and
`inserts. The support ring is thus rigidly attached to the frame
`making the valve in?exible in the lateral direction. Apadded
`suturing rim is formed about the outer periphery of the stent
`by either folding the cloth upon itself or enclosing an
`annulus of resilient foam or sponge rubber With the cloth
`covering.
`The cloth layers are typically formed of porous Woven or
`knitted Te?on or Dacron. The insert elements are formed
`from a sheet or sheets of polyglycol terephthalate (Mylar)
`although other biocompatible materials such as polypropy
`lene may be used.
`The insert elements serve as gussets for increasing the
`axial dimensions of the stent in the Zones betWeen the
`commissure posts and for providing an attachment surface
`for the cloth and the biological valve member. Each insert
`element of the connected series is typically provided With
`apertures through Which stitching is extended during fabri
`cation of the stent.
`With the prior art bioprosthetic valves, the biological
`tissue making up the biological valve member is stitched to
`the inner Wall of the stent. This construction reduces the
`overall opening through Which blood can ?oW through the
`valve. The overall thickness of the stented bioprosthetic
`valve Wall is therefore equal to the sum of the thicknesses of
`the frame Wall and the covering mounted thereon Which is
`approximately 1.5 mm (3 mm in cross-section) and the
`thickness of the tubular Wall of the biological valve member
`Which is approximately 1.5 mm (3 mm in cross-section) for
`a total thickness of approximately 6 mm in cross-section.
`Thus, With the prior art stented bioprosthetic valves the
`overall cross-sectional opening of the replaced valve is 6
`mm smaller than the patient’s natural heart valve.
`Accordingly, the blood ?oWing through the bioprosthetic
`valve is forced through a smaller area than Would ordinary
`?oW through a natural valve thus forcing the heart to Work
`
`NORRED EXHIBIT 2313 - Page 7
`
`

`
`US 6,350,282 B1
`
`3
`harder to circulate the blood through the patient’s body.
`Furthermore, this reduced opening has a greater risk of
`becoming blocked than a healthy natural valve.
`Recent efforts have been made to reduce the overall
`thickness of the valve Wall. These efforts have only concen
`trated on reducing the thickness of the stent Wall. HoWever,
`the thickness of the stent Wall can only be reduced so much
`before the stent loses its structural integrity. No efforts have
`been made to reduce the thickness component due to the
`biological valve member.
`The present invention is directed to overcoming or at least
`minimiZing some of the problems mentioned above.
`
`SUMMARY OF THE INVENTION
`
`In the embodiment of the invention disclosed herein, a
`supported bioprosthetic heart valve is provided. The valve
`includes a stent and a biological valve member. The stent has
`an annular frame de?ned by a support rail. The support rail
`is formed to de?ne a triad of axially-projecting
`circumferentially-spaced commissure posts. Each commis
`sure post has an inverted U-shaped con?guration having a
`rounded upper end and a pair of legs. Each of the pair of legs
`has an upper end and a loWer end. The loWer end of each leg
`merges smoothly With the loWer end of a leg of an adjacent
`commissure post. The biological valve member has an
`in?oW end and an out?oW end, de?ned by a tubular Wall and
`three lea?ets, the three lea?ets being attached to the tubular
`Wall and axially converging along three commissures. The
`out?oW end of the biological valve member is disposed
`under the support rail and has a shape Which ?ts the contour
`of the support rail. A sleeve having an in?oW end and an
`out?oW end is ?tted around the annular frame. The in?oW
`end of the sleeve is sutured to the in?oW end of the
`biological valve member and the out?oW end of the end of
`the sleeve is sutured to the support rail and the out?oW end
`of the biological valve member.
`The bioprosthetic heart valve also includes a suturing cuff
`Which is not rigidly attached to the support ring alloWing the
`valve to expand and contract in the lateral direction. The
`suturing cuff is formed by Wrapping the in?oW end of the
`sleeve around a ring-shaped cushion and suturing the sleeve
`to itself thus encapsulating the ring-shaped cushion. An
`in?oW support ring may also be encapsulated With the
`ring-shaped cushion by the sleeve for added support. In
`another embodiment, the suturing cuff is formed by Wrap
`ping the in?oW end of the sleeve upon itself and suturing the
`sleeve in place. In this latter embodiment, neither the
`ring-shaped cushion nor the in?oW support ring are used.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The foregoing and other features of the present invention
`Will be best appreciated With reference to the detailed
`description of a speci?c embodiment of the invention, Which
`folloWs When read in conjunction With accompanying
`draWings, Wherein:
`FIG. 1 is a perspective vieW of a bioprosthetic heart valve
`according to the present invention.
`FIG. 2 is a perspective vieW of a support rail for the valve
`shoWn in FIG. 1.
`FIGS. 3—6 are perspective vieWs illustrating steps in the
`fabrication of one embodiment of the bioprosthetic valve
`according to the present invention.
`FIG. 4A is perspective vieW illustrating the step shoWn in
`FIG. 4 in the fabrication of an alternate embodiment of the
`bioprosthetic valve according to the present invention.
`
`10
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`15
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`25
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`
`55
`
`65
`
`4
`FIG. 4B is a perspective vieW illustrating the step shoWn
`in FIG. 4 in the fabrication of yet another embodiment of the
`bioprosthetic valve according to the present invention.
`FIG. 7 is a vertical sectional vieW of a completed bio
`prosthetic mitral valve according to the present invention.
`While the present invention is susceptible to various
`modi?cations and alternative forms, speci?c embodiments
`have been shoWn by Way of example in the draWings and
`Will be described in detail herein. HoWever, it should be
`understood that the invention is not intended to be limited to
`the particular forms disclosed. Rather, the invention is to
`cover all modi?cations, equivalents and alternatives falling
`Within the spirit and scope of the invention as de?ned by the
`appended claims.
`
`DETAILED DESCRIPTION OF A SPECIFIC
`EMBODIMENT OF THE INVENTION
`Turning noW to the draWings and referring initially to
`FIG. 1, a bioprosthetic valve adapted for implantation in the
`mitral position is shoWn generally by reference numeral 10.
`Whether the valve is adapted for replacement of a natural
`mitral valve, aortic valve, tricuspid valve or pulmonary
`valve, depends on the siZe of the valve and the construction
`of its suturing cuff or ring. With respect to the present
`invention, all four types of valves have the same essential
`features and, therefore, a mitral valve has been selected for
`illustration purposes only.
`The valve 10 has an in?oW portion 12 and an out?oW
`portion 14. The valve 10 includes a stent 16 and a biological
`valve member 18. The biological valve member 18 has an
`in?oW end 17 and an out?oW end 19 and is de?ned by a
`tubular Wall 20, having an inner surface 22 and an outer
`surface 24 (shoWn in FIG. 7) and lea?ets 26, 28, and 30
`Which are integrally attached to the inner surface of the
`tubular Wall. The lea?ets 26, 28 and 30 converge axially
`along commissures 32. Although in the embodiment illus
`trated valve 10 has three lea?ets and three commissures, it
`should be understood that the concept disclosed herein
`Would be equally applicable to a valve having tWo or more
`lea?ets and commissures.
`The stent 16 includes a ?exible frame 34 Which may be
`made of a thin Wire or contoured thermoplastic material,
`e.g., polypropylene, celcon or acetyl homopolar. The ?ex
`ible frame 34 shoWn in FIG. 2 is de?ned by a support rail 36.
`The ?exible frame 34 is generally annular in con?guration
`having a diameter of 17—35 mm depending on the siZe and
`type of valve being replaced. The support rail 36 forming the
`?exible frame 34 has a triad of axially-projecting and
`circumferentially-spaced commissure posts 38, 40 and 42.
`The commissure posts 38, 40 and 42 project upWardly in the
`direction of the out?oW portion 14 of the valve 10. As shoWn
`in FIG. 2, each commissure post is generally of an inverted
`U-shaped con?guration having legs 44. Each leg 44 merges
`smoothly at its loWer end With a leg of an adjacent com
`missure post.
`The support rail 36 is generally circular in cross section
`and is of substantially uniform diameter throughout its entire
`extent. The diameter of the support rail 36 is approximately
`1 mm. Each inverted U-shaped commissure post has a
`rounded or smoothly-curved upper end. The loWer ends of
`the legs 44 of the commissure posts curve outWardly and
`merge smoothly With the loWer ends of adjacent legs, as
`shoWn in FIG. 2. The support rail 36 may be formed of any
`spring material Which is non-corrosive, fatigue resistant, and
`biocompatible. Stainless steel, a titanium alloy, other alloys
`having similar properties or a thermoplastic material might
`
`NORRED EXHIBIT 2313 - Page 8
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`

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`US 6,350,282 B1
`
`5
`be used. If stainless steel or an alloy is used, the support rail
`36 can serve as a radio paque marker Which can be detected
`from outside the body.
`The stent 16 also includes a generally ring-shaped cushion
`46 disposed at the in?oW portion 12 of the valve 10, as
`shoWn in FIG. 4. The cushion 46 is preferably formed of felt,
`silicone, or a foam material. The stent 16 may also include
`an in?oW support ring 47 (shoWn in FIG. 4) also disposed at
`the in?oW portion 12 of the valve 10 for added support. The
`in?oW support ring 47 is preferably formed of non
`corrosive, fatigue resistant and biocompatible material.
`FIGS. 3—6 illustrate the steps in the fabrication of the
`completed valve 10. First, the stent 16 is constructed. This
`is accomplished by ?rst ?tting a sleeve 48 of porous bio
`compatible fabric, having an in?oW end 50 and an out?oW
`end 52, around the support rail 36, as shoWn in FIG. 3. Next,
`the out?oW end 52 of the sleeve 48 is folded over the support
`rail 36. The outer portion of the sleeve 48 is then sutured to
`the folded portion along the perimeter of the support rail 36,
`as shoWn in FIG. 4. Next, the cushion 46 and the in?oW
`support ring 47 are placed around the in?oW end 50 of the
`sleeve 48, as shoWn in FIG. 4. The in?oW end 50 of the
`sleeve 48 is folded around the cushion 46 and in?oW support
`ring 47 and then sutured to itself encapsulating the cushion
`and in?oW support ring thereby forming a suturing cuff 54,
`as shoWn in FIG. 5.
`FIG. 4A shoWs the fabrication of an alternate embodiment
`of the valve 10 Where the suturing cuff 54 is formed Without
`the in?oW support ring 47. FIG. 4B shoWs the fabrication of
`another alternate embodiment of the valve 10 Where the
`suturing cuff 54 is formed by folding the in?oW end 50 of the
`sleeve 48 upon itself and stitching the sleeve in place. In this
`embodiment, the suturing cuff 54 is formed Without the
`ring-shaped cushion 46 or the in?oW support ring 47.
`The suturing cuff 54 forms a liquid tight seal betWeen the
`bioprosthetic valve 10 and the annulus of the patient pre
`venting blood from leaking through the valve. At the same
`time, the suturing cuff 54 is porous so that it can be sutured
`to the annulus of the patient and alloW the in groWth of tissue
`into the fabric. Because the suturing cuff 54 is not integrally
`formed and rigidly attached to the ?exible frame 34, as With
`the prior art devices, the valve 10 is permitted to ?ex, i.e.,
`expand and contract, in the lateral direction. This provides
`greater ?exibility for the biological valve member 10 mak
`ing it less susceptible to failure in the lateral direction.
`Next, the biological valve member 18 is mounted to the
`stent 12. Prior to mounting, the biological valve member 18
`is trimmed so that it conforms to the contour of the support
`rail 36. Once trimmed, the biological valve member 18 is
`?tted under the support rail 36. The out?oW end 19 of the
`biological valve member 18 is then sutured to the support
`rail 36 and the sleeve 48 along the perimeter of the support
`rail, as shoWn in FIGS. 6 and 7. The stitch is made by seWing
`a suture 56 through the tubular Wall 20 of the biological
`valve member 18, out through the sleeve 48, around the
`support rail 36 and back through the tubular Wall.
`The in?oW end 17 of the biological valve member 18 is
`then stretched and folded under itself so that the folded
`portion is sandWiched in betWeen the tubular Wall 20 and the
`inner layer of the in?oW end 50 of the sleeve 48. The in?oW
`end 17 of the biological valve member 18 is then sutured to
`the inner layer of the in?oW end 50 of the sleeve 48, as
`shoWn in FIG. 6. The stitch is made by seWing a suture 58
`through both layers of the in?oW end 17 of the biological
`valve member 18, through the inner layer of the in?oW end
`50 of the sleeve 48 and back out the sleeve 48 as best seen
`
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`55
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`6
`in FIG. 7. A stitch knoWn as a “box stitch” is particularly
`suitable for this purpose. It should be understood by those of
`ordinary skill in the art, hoWever, that other methods may be
`used in constructing the completed valve 10.
`By suturing the biological valve member 18 under the
`support rail 36, the tubular Wall 20 is integrated into the stent
`Wall rather than attached adjacent to it as With prior stented
`valves. Accordingly, the thickness of the valve Wall is equal
`to the thickness of the tubular Wall 20, Which is approxi
`mately 1.5 mm, plus the thickness of the tWo layers of the
`sleeve 48 (since it is folded over itself), Which is approxi
`mately 0.5 mm (0.25 mm for each layer), for a total
`thickness of approximately 2.0 mm. Since the biological
`valve member 18 is secured beneath the support rail 36
`rather than adjacent to it, the thickness of the support rail,
`Which is less than the thickness of the tubular Wall 20
`(approximately 1 mm), is not added to the overall thickness
`of the valve Wall. Therefore, by eliminating the thickness of
`the support rail 36 from the thickness of the stent Wall, the
`overall thickness of the valve Wall is reduced by approxi
`mately 2.0 mm in the cross-sectional direction.
`This construction provides a signi?cant advantage over
`the prior art. By reducing the thickness of the valve Wall by
`approximately 2.0 mm, the opening of the valve 10 is
`correspondingly increased by 2.0 mm. This alloWs blood to
`?oW through the valve 10 more freely than With prior art
`devices and hence reduces the chance of blockage. Also, the
`heart does not have to Work as hard to force blood through
`the valve 10 as it does With prior art valves having smaller
`openings. The valve 10, therefore, has the superior hemo
`dynamics of a stentless valve, While offering the ease of
`implantation associated With a stented valve.
`FIG. 7 illustrates details of the completed valve With the
`biological valve member 18 secured under the support rail
`36 by sutures 56. The con?guration and location of the
`suturing cuff 54 is particularly suited for use of the valve as
`a mitral valve replacement. The valve 10 illustrated in FIG.
`7 can be adapted for replacement of the aortic, tricuspid or
`pulmonary valve With minor modi?cation as those of ordi
`nary skill in the art Will appreciate. By modifying the shape
`and position of the suturing cuff 54 and as Well as the
`dimensions of the valve members taking into account those
`differences occasioned by the anatomical characteristics of
`those portions of the human heart to Which the respective
`valves are to be secured, the valve illustrated in FIG. 7 can
`be used for replacement of any human heart valve.
`I claim:
`1. A supported bioprosthetic heart valve having an in?oW
`and and out?oW side, the heart valve comprising:
`a) a stent having an annular frame de?ned by a support
`rail, the support rail having an in?oW and an out?oW
`side corresponding to the in?oW and out?oW sides of
`the heart valve, the annular frame de?ning relatively
`exterior and interior directions;
`b) a biological valve member de?ned by a tubular Wall
`and a plurality of lea?ets, the plurality of lea?ets being
`attached to the tubular Wall and axially converging
`along commisures of the plurality of lea?ets, the bio
`logical valve member extending
`i) from the out?oW side of the heart valve toWard the
`out?oW side of the heart valve and ending at the
`in?oW side of the support rail; and
`ii) not extending around the support rail; and
`c) a sleeve ?tted around and tangentially exterior to the
`annular frame, the sleeve having an in?oW end and an
`out?oW end, the out?oW end being folded interiorly
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`NORRED EXHIBIT 2313 - Page 9
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`US 6,350,282 B1
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`7
`over the support rail and secured to the support rail
`along the entire annular perimeter of the support rail
`such that a recess is formed along the entire annular
`perimeter of the support rail directly underneath the
`support rail, the sleeve also secured to the biological
`valve member such that an out?oW end of the tubular
`Wall of the biological valve member is secured to the
`sleeve Within the recess directly underneath the entire
`annular perimeter of the support rail and Whereby the
`overall thickness of the valve Wall at the tubular Wall of
`the biological valve member includes the thickness of
`the biological valve member and the sleeve and does
`not include the thickness of the support rail.
`2. The supported bioprosthetic heart valve of claim 1, in
`Which the in?oW end of the sleeve is folded upon itself and
`sutured in place to form a suturing cuff.
`3. The supported bioprosthetic heart valve of claim 1,
`further comprising a ring shaped cushion disposed around
`the sleeve at the in?oW end.
`4. The supported bioprosthetic heart valve of claim 3, in
`Which the in?oW end of the sleeve is Wrapped around the
`ring-shaped cushion and sutured to itself to encapsulate the
`ring-shaped cushion and form a suturing cuff.
`5. The supported bioprosthetic heart valve of claim 3,
`further comprising an in?oW support ring disposed around
`the sleeve at the in?oW end adjacent to the ring-shaped
`cushion.
`6. The supported bioprosthetic heart valve of claim 5, in
`Which the in?oW end of the sleeve is Wrapped around the
`ring-shaped cushion and the in?oW support ring and sutured
`to itself to encapsulate the ring-shaped cushion and in?oW
`support ring to form a suturing cuff.
`7. The supported bioprosthetic heart valve of claim 1, in
`Which the support rail comprises a triad of axially-projecting
`circumferentially-spaced commissure posts, each commis
`sure post having an inverted U-shaped con?guration com
`prising a rounded upper end and a pair of legs, each of the
`pair of legs comprising an upper end and a loWer end, the
`loWer end of each leg curving outWardly and merging
`smoothly With the loWer end of a leg of an adjacent
`commissure post.
`8. The supported bioprosthetic heart valve of claim 1
`Wherein the folded sleeve is secured to the support rail along
`a perimeter of the support rail by suturing an outer portion
`of the sleeve to the folded portion of the sleeve.
`9. The supported bioprosthetic heart valve of claim 1
`Wherein the tubular Wall of the biological valve member is
`secured to the sleeve Within the recess by a suture through
`the tubular Wall of the biological valve member, around the
`support rail and back through the tubular Wall.
`10. A supported bioprosthetic heart valve having an
`in?oW and an out?oW side, the heart valve comprising:
`a) a stent having an annular frame de?ning relatively
`exterior and interior directions, and including a support
`rail, the support rail having a contour de?ned by a triad
`of axially-projecting circumferentially-spaced commis
`sure posts, the support rail having an in?oW and an
`out?oW side corresponding to the in?oW and out?oW
`sides of the heart valve;
`b) a biological valve member having an in?oW end and an
`out?oW end, a tubular Wall and three lea?ets, the three
`
`10
`
`15
`
`25
`
`35
`
`45
`
`55
`
`8
`lea?ets being attached to the tubular Wall and axially
`converging along three commissures, the tubular Wall
`of the biological valve member extending from the
`in?oW side of the heart valve toWard the out?oW side
`of the heart valve and ending at the in?oW side of the
`support rail in a shape that conforms to the shape of the
`support rail, but not extending around, the support rail;
`and
`a sleeve ?tted around and tangentially exterior to the
`annular frame, the sleeve having an in?oW end and an
`out?oW end, the out?oW end being folded interiorly
`over the support rail and secured to the support rail
`along the entire annular perimeter of the support rail
`such that a recess is formed along the entire annular
`perimeter of the support rail directly underneath the
`support rail, the sleeve also secured to the biological
`valve member such that an out?oW end of the tubular
`Wall of the biological valve member is secured to the
`sleeve Within the recess directly underneath the entire
`annular perimeter of the support rail and Whereby the
`overall thickness of the valve Wall at the tubular Wall of
`the biological valve member includes the thickness of
`the biological valve member and the sleeve and does
`not include the thickness of the support rail.
`11. The supported bioprosthetic heart valve of claim 10,
`in Which the in?oW end of the sleeve is folded upon itself
`and stitched in place to form a cuff that is not rigidly attached
`to the support rail so that the valve may expand and contract
`in a lateral direction.
`12. The support bioprosthetic heart valve of claim 10,
`further comprising a ring-shaped cushion disposed around
`the sleeve at the inflow end.
`13. The supported bioprosthetic heart valve of claim 12,
`in Which the in?oW end of the sleeve is Wrapped around the
`ring-shaped cushion and sutured to itself to encapsulate the
`ring-shaped cushion and form a suturing cuff that is not
`rigidly attached to the support rail so that the valve may
`expand and contract in a lateral direction.
`14. The supported bioprosthetic heart valve of claim 12,
`further comprising an in?oW support ring disposed around
`the sleeve at the in?oW end adjacent to the ring-shaped
`cushion.
`15. The supported bioprosthetic heart valve of claim 14,
`in Which the in?oW end of the sleeve is Wrapped around the
`ring-shaped cushion and the in?oW support ring and is
`sutured to itself to encapsulate the ring-shaped cushion and
`in?oW support ring and form a supported suturing cuff that
`is not rigidly attached to the support rail so that the valve
`may expand and contract in a lateral direction.
`16. The supported bioprosthetic heart valve of claim 10
`Wherein the folded sleeve is secured to the support rail along
`a perimeter of the support rail by suturing an outer portion
`of the sleeve to the folded portion of the sleeve.
`17. The supported bioprosthetic hea