(12) United States Patent
`Gabbay
`
`US006264691B1
`US 6,264,691 B1
`Jul. 24, 2001
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`(54)
`
`(76)
`
`APPARATUS AND METHOD FOR
`SUPPORTING A HEART VALVE
`
`Inventor: Shl0m0 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 0 days.
`
`(21)
`(22)
`(51)
`(52)
`
`(58)
`
`(56)
`
`Appl. No.: 09/298,493
`Filed:
`Apr. 23, 1999
`
`Int. Cl.7 ..
`
`............................. .. A61F 2/24
`
`US. Cl. ..................... .. 623/2.14; 623/218; 623/238;
`623/904; 600/37
`Field of Search ................................ .. 623/238, 2.39,
`623/24, 212—219, 900, 904; 600/37
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3/1971 Hancock.
`3,570,014
`6/1973 Cooley et a1. .
`3,739,402
`7/1977 Angell et a1. .
`4,035,849
`10/1984 Totten et a1. .
`4,477,930
`7/1988 Gabbay.
`4,759,758
`7/1991 Alonso .
`5,032,128
`10/1992 Navia et a1. .
`5,156,621
`5,545,215 * 8/1996 Duran .............................. .. 623/21 X
`5,584,879
`12/1996 Reimold et a1. .
`
`FOREIGN PATENT DOCUMENTS
`
`95/28899 * 11/1995 (WO) ................................ .. 623/219
`
`OTHER PUBLICATIONS
`
`“An Appraisal of the Ross Procedure: Goals & Technical
`Guidelines”, Operative Techniques in Cardiac & Thoracic
`Surgery, vol. 2, No. 4, Nov. 1997; pp. 289—301.
`“Modi?ed Pulmonary Autograft Aortic Root Replacement:
`The Sinus Obliteration Technique”, Michael D. Black, MD,
`Jacques A. M. von Son, MD, PhD & Frank L. Hanley, MD,
`The Society of Thoracic Surgeons, 1995; 60:1434—6.
`
`* cited by examiner
`
`Primary Examiner—David H. Willse
`(74) Attorney, Agent, or Firm—Amin & Turocy, LLP
`(57)
`ABSTRACT
`
`An apparatus and method are disclosed for supporting a
`heart valve With a ?exible girdle. The girdle has an elongated
`cylindrical sideWall having an axial length at least commen
`surate With the heart valve. The girdle is disposed around a
`tubular valve Wall of the heart valve being implanted so that
`the in?ow end of the girdle is adjacent the in?ow end of the
`tubular valve Wall. The in?oW ends of the girdle and heart
`valve may then be sutured together to implant the valve. The
`girdle provides support to stabilize the heart valve and
`inhibit deformation thereof.
`
`44 Claims, 3 Drawing Sheets
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`NORRED EXHIBIT 2108 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case IPR2014-00110
`
`

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`U.S. Patent
`
`Jul. 24, 2001
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`Sheet 1 of3
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`US 6,264,691 B1
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`NORRED EXHIBIT 2108 - Page 2
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`U.S. Patent
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`Jul. 24, 2001
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`Sheet 2 of3
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`US 6,264,691 B1
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`MHHHHHHHHHH/ \
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`NORRED EXHIBIT 2108 - Page 3
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`U.S. Patent
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`Jul. 24, 2001
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`Sheet 3 of3
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`US 6,264,691 B1
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`NORRED EXHIBIT 2108 - Page 4
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`US 6,264,691 B1
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`1
`APPARATUS AND METHOD FOR
`SUPPORTING A HEART VALVE
`
`CROSS REFERENCE TO RELATED
`APPLICATION
`
`This application is related to US. patent application Ser.
`No. 09/1052,707, now US. Pat. No. 5,935,163, Which Was
`?led Mar. 31, 1998 and entitled Natural Tissue Heart Valve
`Prosthesis.
`
`TECHNICAL FIELD
`
`The present invention relates to an apparatus and method
`for supporting a heart valve. More particularly, the present
`invention relates to an apparatus and method for supporting
`a heart valve by disposing a girdle externally about the
`valve.
`
`BACKGROUND OF THE INVENTION
`
`The use of a patient’s healthy pulmonic valve as an
`autograft to replace a diseased aortic valve has been gaining
`WorldWide acceptance as a viable alternative for replacing
`the patient’s diseased aortic valve. This procedure is knoWn
`as the Ross procedure after the surgeon Who introduced the
`procedure in 1967.
`The Ross procedure is performed by transplanting a
`patient’s healthy pulmonic valve along With a portion of the
`pulmonary artery to replace the aortic valve and a feW
`centimeters of the aorta. The left and right coronary arteries
`are attached to the valve Wall of the pulmonary autograft
`after making small slits through the valve Wall into coronary
`sinuses of the autograft.
`The pulmonic valve is typically replaced by a homograft,
`such as a pulmonic or aortic heart valve from a cadaver. The
`Ross procedure is preferred over other heart valve replace
`ment procedures, especially for individuals Who are unable
`to take anticoagulation drugs. The Ross procedure has
`received substantial discussion in various publications.
`For example, Oury et al., An Appraisal of the Ross
`Procedure: Goals and Technical Guidelines, Operative Tech
`niques in Cardiac and Thoracic Surgery, Vol. 2, No. 4
`(November), 1997: pp. 289—301, describes the Ross proce
`dure as Well as some alternative techniques for performing
`the procedure.
`Black et al., Modi?ed Pulnronary Autograft Aortic Root
`Replacement: The Sinus Obliteration Technique, Ann Tho
`racic Surgery, 1995; 60:1434—1436, describes a rather com
`plicated technique to remedy a frequent problem of dilation
`of the pulmonary autograft folloWing the Ross procedure.
`This approach utiliZes large coronary buttons to replace the
`pulmonary sinus completely and leaves the non-coronary
`aortic sinus to support the non-coronary sinus of the pul
`monary autograft.
`
`SUMMARY OF THE INVENTION
`
`The present invention is directed to an external support
`apparatus for a heart valve that is disposed Within an
`elongated tubular valve Wall. The apparatus includes a girdle
`having an elongated cylindrical sideWall With in?oW and
`out?oW ends that are spaced apart an axial length that is at
`least substantially commensurate With the axial length of the
`heart valve disposed Within the tubular valve Wall.
`Preferably, at least tWo apertures are formed through the
`sideWall of the girdle and spaced axially from the in?oW end
`thereof. The apertures are spaced circumferentially apart for
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`generally radial alignment With corresponding sinuses of the
`heart valve Which is to be supported by the girdle. The
`in?oW end of the girdle preferably is folded toWard the
`out?oW end to provide additional support at its in?oW end.
`In another embodiment, the girdle, as described above, is
`further supported by a stent disposed externally about the
`sideWall of the girdle.
`Yet another embodiment of the present invention is
`directed to a method for improving implantation of a heart
`valve having in?oW and out?oW ends and located Within a
`tubular valve Wall. An elongated cylindrical girdle is dis
`posed about the tubular valve Wall and the heart valve
`located therein so as to inhibit deformation of the heart
`valve. The girdle has a cylindrical sideWall portion With
`in?oW and out?oW ends spaced apart an axial length at least
`substantially commensurate With the axial length of the heart
`valve located Within the Zubular valve Wall. The in?oW end
`of the girdle is positioned adjacent the in?oW end of the
`tubular valve Wall. During implantation of the heart valve,
`the in?oW ends of the valve and girdle preferably are secured
`together to an out?oW annulus of the heart.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The foregoing and other features and advantages of the
`present invention Will become apparent to those skilled in
`the art to Which the present invention relates upon reading
`the folloWing description With reference to the accompany
`ing draWings, Wherein:
`FIG. 1 is a ?rst embodiment of an apparatus in accordance
`With the present invention;
`FIG. 2 is a second embodiment of an apparatus in
`accordance With the present invention;
`FIG. 3 is a third embodiment of an apparatus in accor
`dance With the present invention;
`FIG. 4 is a fourth embodiment of an apparatus in accor
`dance With the present invention;
`FIG. 5 is a ?fth embodiment of an apparatus in accor
`dance With the present invention;
`FIG. 6 is a sixth embodiment of an apparatus in accor
`dance With the present invention;
`FIG. 7 is an is ometric vieW of the apparatus of FIG. I
`mounted to a heart valve being implanted to a patient’s
`heart;
`FIG. 8 is an isometric vieW, similar to FIG. 7, illustrating
`a completed heart valve transplant procedure using the
`apparatus of FIG. 1; and
`FIG. 9 is an isometric vieW of the apparatus of FIG. 5
`disposed about a heart valve in accordance With the present
`invention.
`
`DESCRIPTION OF PREFERRED
`EMBODIMENTS
`
`FIG. 1 illustrates a ?rst embodiment of a heart valve
`girdle 10 in accordance With the present invention. The
`girdle 10 has an in?oW end 14 and an out?oW end 16 spaced
`apart by a length of a cylindrical sideWall 18. The terms
`“in?oW” and “out?oW” are used herein to refer to ends of the
`girdle Which are to be positioned at corresponding ends of a
`heart valve.
`Because the girdle 10 is to be mounted externally about a
`heart valve, such as an autogenous or homogenous heart
`valve disposed Within a length of a tubular valve Wall, the
`axial length of the sideWall 18 is at least substantially
`commensurate With the axial length of the heart valve Which
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`is to be mounted therein. The girdle 10 also has an inner
`diameter substantially equal to the outer diameter of the
`tubular valve Wall surrounding the heart valve. The girdle 10
`my by provided in a variety of siZes from Which a surgeon
`may select an appropriate siZe of girdle. The elongated
`sideWall 18 supports and stabiliZes the heart valve from its
`in?oW end to its out?oW end, thereby inhibiting deformation
`of the valve When implanted.
`Preferably, the girdle 10 is formed from a sheet of a
`?exible material. The ?exible material may, for example, be
`a textile material, such as Dacron, or an animal tissue
`material, such as bovine pericardium, equine pericardium,
`porcine pericardium, human pericardium, or other biological
`materials. The girdle 10 alternatively could be formed of a
`?exible plastic-like material, such as a natural or synthetic
`polymer, for example, Delrin.
`In the preferred embodiment, the girdle 10 is formed from
`a strip of pericardium Which has been treated, or tanned, to
`render the tissue biocompatible, as is knoWn in the art. The
`cyLindrical sideWall 18 of the girdle 10 is, for example,
`formed from a rectangular strip of pericardium having ends
`that have been attached together end-to-end, such as by
`sutures 20. The pericardial tissue may be treated before
`and/or after the girdle 10 has been formed into its tubular
`con?guration. By treating the pericardial tissue material
`mounted over a right circular, cylindrical mandrel, for
`example, the girdle 10 is permanently ?xed in its desired
`tubular shape.
`At least tWo and preferably three apertures 22, 24 and 26
`are formed through the sideWall 18 of the girdle 10 at an
`axial location intermediate the ?rst and second ends 14 and
`16. In order to facilitate proper alignment of the girdle 10
`about the heart valve, each of the apertures 22, 24 and 26 is
`spaced circumferentially apart for generally radial alignment
`With a corresponding sinus of the heart valve to be mounted
`therein. By Way of example, a pulmonic autograft, as Well as
`a homograft, such as from a cadaver, has three lea?ets With
`sinuses located at the out?oW end of the valve betWeen
`commissures of each adjacent pair of lea?ets. The apertures
`22, 24, and 26 of the girdle 10 are spaced circumferentially
`apart from adjacent apertures, generally about 120° apart, so
`as to correspond to a location of a respective sinus of the
`heart valve.
`The in?oW end 14 of the girdle 10 preferably is folded
`radially outWard and toWard the out?oW end 16 of the girdle
`to form an outer folded portion 27. The radially outer folded
`portion 27 is connected to the radially inner portion of the
`sideWall 18, such as by sutures 28. This provides tWo
`overlapping layers of the sideWall 18 at the in?oW end 14 of
`the girdle 10 to further help stabiliZe the in?oW end of the
`heart valve. The folded portion 27 also provides an implan
`tation ?ange to facilitate implantation of the heart valve to
`an out?oW annulus of the heart as Well as to inhibit dilation
`of the heart valve.
`FIG. 2 illustrates a second embodiment of a girdle 10‘ in
`accordance With the present invention in Which reference
`numbers, modi?ed by adding a prime symbol, are used to
`refer to similar parts of the girdle of FIG. 1. The apertures
`22‘, 24‘, and 26‘ are substantially enlarged When compared to
`the apertures of FIG. 1. Speci?cally, the circumferential arc
`of the sideWall 18 extending betWeen adjacent apertures 22‘,
`24‘ and 26‘ is substantially less than the circumferential arc
`of each aperture. In addition, the axial length of sideWall
`portion 18‘ betWeen each aperture 22‘, 24‘ and 26‘ and the
`in?oW and out?oW ends 14‘ and 16‘ also is substantially less
`than the axial length of each aperture.
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`The girdle 10‘ of FIG. 2 advantageously facilitates the
`positioning of the girdle around the heart valve. This is
`because tWo of the large apertures 22‘, 24‘, 26‘ are more
`easily aligned With coronary sinuses of the heart valve being
`implanted. Attachment of the coronary arteries to the valve
`Wall of a heart valve mounted Within the girdle 101 also is
`facilitated because of the larger surface area of the valve’s
`sideWall exposed through each aperture 22‘, 24‘ and 26‘.
`FIG. 3 is a third embodiment of a girdle 100 in accordance
`With the present invention. The girdle 100 includes an
`elongated inner tubular sheath 102 having an elongated
`cylindrical sideWall 104 Which, like the embodiments of
`FIGS. 1 and 2, has an axial length at least substantially
`commensurate With the axial length of the heart valve to be
`mounted therein. The inner sheath 102 has an in?oW end 106
`and an out?oW end 108 spaced apart by the sideWall portion
`104.
`A stent 110 having an annular in?oW end 112 and an
`out?oW end 114 is disposed about the inner sheath 102
`intermediate its in?oW and out?oW ends 106 and 108,
`respectively. The stent 110 preferably ?ts snugly over the
`inner sheath 102. The stent 110 is formed of a ?exible
`material, suitably a resilient metal or a plastic-like material,
`such as Delrin. Other resilient, ?exible materials such as
`textile materials, pericardial tissue, or other biocompatible
`materials, also may be used to form the stent 110.
`At least the out?oW end 114 of the stent 110 is generally
`sinusoidal With alternating peaks 116, 118, 120 and sinuses
`122, 124, 126, respectively. The peaks 116, 118, and 120 are
`de?ned by elongated stent posts 128, 130, and 132, Which
`are spaced circumferentially apart. The sinuses 122, 124,
`and 126 are formed betWeen each adjacent pair of stent posts
`128, 130 and 132. The circumferential positioning of the
`stent posts 128, 130, and 132 corresponds to the circumfer
`ential positioning of the commissures of adjacent lea?ets of
`the heart valve.
`An outer sheath 134 of a biocompatible material, such as
`pericardium, a textile material, or any other biocompatible,
`?exible material, covers the stent 110 and at least a substan
`tial portion of the inner sheath 102. The outer sheath 134 has
`an in?oW end 136 and an out?oW end 138 spaced axially
`apart from the in?oW end 136 by a length of cylindrical
`sideWall 140.
`The in?oW end 136 of the outer sheath 134 is positioned
`adjacent the in?oW end 106 of the inner sheath 102. The
`overlapping Layers adjacent the in?oW ends 132 and 106
`provide additional support at the in?oW end of the heart
`valve, similar to the folded portions 27 and 27‘ of FIGS. 1
`and 2, respectively. A fold also may be added to one or both
`of the in?oW ends 106, 136 to provide further stabiliZation
`at the in?oW end of the heart valve.
`The out?oW end 138 of the outer sheath 134 is spaced
`from the out?oW end 114 of the stent 110. Preferably, the
`out?oW end 138 of the outer sheath 134 is contoured
`according to the out?oW end 114 of the stent 110. That is, it
`has elongated ?anges 142, 144 and 146, Which cover each of
`the respective stent posts 128, 130, and 132. Sinuses are
`formed betWeen adjacent pairs of ?anges 142, 144, 146. The
`out?oW end 138 of the outer sheath 134 is connected to the
`sideWall 104 of the inner sheath 102, such as by sutures 148.
`The sutures 148 limit or prevent axial movement of the stent
`110 in a direction from the in?oW end 106 toWard the
`out?oW end 108 of the inner sheath 102.
`The sideWall portions 104 and 140 alternatively could be
`coextensive, With the out?oW end 138 of the outer sheath
`134 connected to the out?oW end 108 of the inner sheath
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`102. In addition, the in?ow ends 106 and 136 and may be
`connected together by sutures (See FIG. 8) When the heart
`valve is implanted to an appropriate out?ow annulus of a
`patient’s heart. This maintains the axial as Well as angular
`positioning of the stent 110 betWeen the in?oW and out?oW
`ends 136 and 138 of the outer sheath 134.
`FIG. 4 is another embodiment of a girdle 100‘, in accor
`dance With the present invention, in Which a prime symbol
`(‘) has been added to the reference numbers of FIG. 3 to
`indicate corresponding parts. The girdle 100‘ is substantially
`identical to the girdle 100 of FIG. 3. HoWever, a plurality of
`apertures 150, 152 and 154 are formed through the sideWall
`104‘ of the inner sheath 102‘.
`The apertures 150, 152, and 154 are substantially identical
`to the apertures 22, 24 and 26 shoWn and described With
`respect to FIG. 1. The apertures 150, 152, and 154 are spaced
`axially apart from the in?oW and out?oW ends 106‘ and 108‘.
`The apertures 150, 152, and 154 also are spaced axially from
`the sinusoidal out?oW end 138‘ of the outer sheath 134‘. In
`addition, the apertures 150, 152, and 154 are spaced cir
`cumferentially apart and located intermediate adjacent stent
`posts 128‘, 130‘ and 132‘ for generally radial alignment With
`corresponding sinuses of a heart valve to be mounted
`therein. The apertures 150, 152, and 154 provide access to
`the sinuses of the heart valve, such as a pulmonary autograft,
`to facilitate connecting the left and right coronary arteries
`through the apertures and to the valve Wall surrounding the
`heart valve.
`FIG. 5 is another embodiment of a girdle 100“ in accor
`dance With the present invention in Which a double prime
`symbol (“) has been added to reference numbers of FIGS. 3
`and 4 to indicate corresponding parts. The girdle 100“ is
`substantially identical to the girdle 100‘ of FIG. 4, although
`the apertures 150“, 152“, and 154“ have been enlarged to
`facilitate alignment of tWo of the apertures 150“, 152“, and
`154“ With coronary sinuses of the heart valve to be mounted
`therein. Speci?cally, the outer sheath 134“ has a sinusoidal
`out?oW end 138“ With elongated ?anges 142“, 144“ and
`146“ radially aligned With and covering respective stent
`posts 128“, 130“ and 132“. Sinuses are formed betWeen
`adjacent ?anges 142“, 144“, 146“. The apertures 150“, 152“,
`and 154“ are formed through the inner sheath 102“ coex
`tensively With each such sinus of the outer sheath 134“. The
`circumferential arc of the sideWall portion 104“ extending
`betWeen adjacent apertures 150“, 152“ and 154‘‘, eg the
`circumferential arc length of ?anges 142“, 144“ and 146“, is
`substantially less than the circumferential arc of each aper
`ture.
`FIG. 6 illustrates yet another embodiment of a girdle 200
`in accordance With the present invention. The girdle 200 is
`generally similar to the girdles 100, 100‘, and 100“ of FIGS.
`3—5. The girdle 200 includes an elongated inner sheath 202
`having an in?oW end 204 and an out?oW end 206 spaced
`axially apart by a cylindrical sideWall portion 208.
`In this embodiment, the out?oW end 206 of the inner
`sheath 202 is sinusoidal to correspond to the contour of the
`out?oW end of a heart valve to be mounted therein.
`Speci?cally, the out?oW end 206 includes a plurality of
`elongated ?anges 210, 212, and 214 Which are spaced
`circumferentially apart. In this Way, sinuses 216, 218, and
`220 are formed in the out?oW end 206 betWeen each
`adjacent pair of ?anges 210, 212, and 214.
`A?exible stent or annular ring 222, Which is substantially
`identical to that shoWn and described With respect to FIGS.
`3—5, is disposed about the inner sheath 202 to provide
`additional radial support. The stent 222 includes axially
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`spaced apart in?oW and out?oW ends 224 and 226. The
`out?oW end 226 is sinusoidal With circumferentially spaced
`apart and elongated stent posts 228, 230, and 232 extending
`axially from the annular portion at in?oW end 224. Each
`stent post 228, 230, and 232 is radially aligned and extends
`substantially coextensively With one of the respective
`?anges 210, 212, and 214, as shoWn in FIG. 6. The stent 222
`also has sinuses 229, 231 and 233 formed betWeen adjacent
`pairs of stent posts 228, 230 and 232. The in?oW and out?oW
`ends 224 and 226 of the stent 222 are spaced axially apart
`from the respective in?oW and out?oW ends 204 and 206 of
`the inner sheath 202 to form a generally cylindrical sideWall
`portion therebetWeen.
`An outer sheath 236 of a ?exible material, such as a textile
`or animal tissue material, is disposed externally over the
`stent 222 and at least a portion of the inner sheath 202. The
`outer sheath 236 has an in?oW end 238 adjacent the in?oW
`end 204 of the inner sheath 202 and an out?oW end 240
`adjacent the out?oW end 206 of the inner sheath. Preferably,
`the out?oW end 240 of the outer sheath 236 also is sinusoidal
`With corresponding elongated peaks or ?anges 242, 244, and
`246 radially aligned and substantially coextensive With the
`respective ?anges 210, 212, and 214 of the inner sheath 202
`and the stent posts 228, 230, and 232. The out?oW end 240
`also has sinuses at its out?oW end intermediate adjacent
`pairs of the elongated peaks 242, 244, and 246, Which outer
`sheath sinuses are aligned With the inner sheath sinuses 216,
`218, and 220. The outer sheath 236 alternatively may have
`an axial length about equal With axial length of the inner
`sheath 202, so that the stent 222 is sandWiched betWeen
`concentric inner and outer cylindrical sheaths.
`In vieW of the various embodiments of girdles described
`above, their use may be better appreciated With reference to
`FIGS. 7—9. While FIGS. 7—9 disclose the use of tWo
`particular girdle embodiments, it Will be understood and
`appreciated that each of the girdle embodiments shoWn in
`FIGS. 1—6 may, in accordance With the present invention, be
`used to support a heart valve being implanted.
`FIG. 7 illustrates part of a surgical procedure in Which a
`girdle 300, as shoWn in FIG. 1, has been attached about an
`autogenous heart valve, preferably a pulmonary autograft
`302. The procedure preferably folloWs the steps of the Ross
`procedure, such as described in Oury et al., An Appraisal of
`the Ross Procedure: Goals and Technical Guidelines, Opera
`tive Techniques in Cardiac and Thoracic Surgery, Vol. 2, No.
`4 (November), 1997: pp. 289—301, Which is incorporated
`herein by reference.
`In FIG. 7, the Ross procedure is at an intermediate stage
`in Which the diseased aortic valve already has been removed
`and discarded. A pulmonary autograft 302 is formed of a
`healthy pulmonary heart valve 303 Which is disposed Within
`an elongated portion of the tubular valve Wall or pulmonary
`artery 306. The portion of the pulmonary artery 306 enclos
`ing the heart valve 303 has been excised from the pulmonary
`trunk of the patient.
`The external support girdle 300, in accordance With the
`present invention, is disposed about the pulmonary autograft
`valve 302. The girdle 300 has apertures 308 and 310 Which
`are radially and axially aligned With the sinuses of coronary
`lea?ets 312 and 314 of the pulmonary autograft 302.
`During the Ross procedure, small incisions or slits are
`made in the tubular valve Wall 306 of the pulmonary
`autograft 302 over Which buttons 318 and 320 are attached.
`The buttons 318 and 320 are formed of sideWall portions of
`the aortic valve Wall from the patient’s aortic valve Which
`has been removed. The buttons 318 and 320 are connected
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`With the right and left coronary arteries 322 and 324,
`respectively. The right and left coronary arteries 322 and 324
`terminate at the buttons 318 and 320 to form ostias or
`openings 326 and 328 Which are subsequently aligned With
`slits formed in the valve Wall 306 of the pulmonary autograft
`302.
`As shoWn in FIG. 7, the girdle 300 has an out?oW end 330
`located adjacent but spaced apart from an out?oW end 332
`of the pulmonary valve Wall 306. An in?oW end 334 of the
`girdle 300 is located adjacent an in?oW end 336 of the
`pulmonary valve Wall 306 and includes a fold 338, as
`described above, to help inhibit dilation at the in?oW end
`336 of the pulmonary autograft 302. The out?oW end 332 of
`the pulmonary valve Wall 306 is anastornosed to the aorta
`340, such as by sutures 342.
`Another girdle 348, in accordance With the present
`invention, is mounted over a hornograft heart valve 350. The
`hornograft 350 has an out?oW end 352 Which has been
`anastornosed to the pulmonary trunk 354. An in?oW end 356
`of the girdle 348 is positioned adjacent the in?oW end 358
`of the hornograft 350. An out?oW end 360 of the girdle 348
`preferably is spaced from the out?oW end 352 of the
`hornograft 350, although it easily could be made longer so
`that the girdle 348 and hornograft 350 are coextensive.
`While the girdle 348 is shoWn to include apertures 362
`and 364, such apertures are super?uous for the pulmonary
`valve replacement. HoWever, manufacturing costs may be
`reduced by fabricating a single type of girdle 300, 348 for
`use during the Ross procedure. The girdles 300, 348 typi
`cally are produced in various siZes Which are to be selected
`by the surgeon performing the procedure.
`FIG. 8 illustrates the completed procedure in Which the
`in?oW end 336 of the pulmonary autograft 302 and the
`in?oW end 334 of the girdle 300 have been connected
`together and anastornosed to the right ventricle out?oW tract
`370, suitably by interrupted or continuous sutures 372. In
`addition, the right and left coronary artery buttons 318 and
`320 have been connected over appropriate slits (not shoWn)
`formed in the pulmonary valve Wall 306 through the aper
`tures 308 and 310, thereby connecting the coronary arteries
`With coronary sinuses of the autograft 302. The in?oW end
`356 of the girdle 348 and the in?oW end of the pulmonary
`hornograft 350 also are connected together and are anasto
`rnosed to the left ventricle out?oW tract 376 by sutures 378.
`FIG. 9 illustrates a heart valve, such as a pulmonary valve
`401 disposed Within its outer tubular valve Wall 402 de?ne
`a pulmonary autograft 403. The autograft 403 is mounted
`Within a girdle 404, such as the girdle shoWn in FIG. 5. As
`can be seen, each sinus 406, 408, and 410 formed in the
`out?oW end of the valve 401 is aligned With a corresponding
`sinus 412, 414 and 416 of the girdle 404. An in?oW end 418
`of the girdle 404 is positioned ad.,acent the in?oW end 419
`of the valve Wall 402. The in?oW ends 418 and 419 are
`connected together and anastornosed to an out?oW annulus,
`schernatically indicated at 422, by sutures 424. An out?oW
`end 426 of the pulmonary valve Wall 402 extends axially
`beyond an out?oW end 428 of the tubular inner sheath 430
`of the girdle 404. The out?oW end 426 of the valve Wall 402
`Will be anastornosed to the aorta (not shoWn) in a manner
`knoWn in the art.
`Left and right coronary arteries 430 and 432 are attached
`to the valve Wall 402 through respective apertures 434 and
`436 of the girdle 404. In particular, the coronary arteries 430
`and 432 terminate in buttons 438 and 440 Which are anas
`tornosed to the valve Wall 402 over slits or apertures (not
`shoWn) that have been formed through the valve Wall. Such
`slits provide access into coronary sinuses 408 and 406 of the
`valve 401.
`
`10
`
`15
`
`25
`
`35
`
`45
`
`55
`
`65
`
`8
`Advantageously, a girdle, in accordance With the present
`invention, stabiliZes the base of the heart valve and supports
`the cornrnissures so as to inhibit their inWard de?ection. The
`girdle also increases the durability of the autograft and
`hornograft valve by inhibiting annular dilation and/or defor
`rnities which might otherWise occur during normal function
`ing of the heart. Such deforrnities often lead to rnalcoapta
`tion Which, in turn, tends to cause insuf?ciency and failure.
`The girdles advantageously prornote coaptation of the leaf
`lets of the autograft and hornograft. This, in turn, reduces the
`likelihood of failure and the need for reoperation after
`surgical procedures, such as the Ross procedure.
`Each of the girdles of FIGS. 1—6 also may be formed
`entirely of an absorbable synthetic or biological material,
`such as an absorbable textile material or an absorbable
`treated anirnal tissue material, for example, pericardiurn.
`The absorbable rnaterial girdle is especially advantageous
`for young patient’s undergoing the Ross procedure. Because
`the autograft is formed of the patient’s oWn tissue, for
`relatively young individuals, the autograft Will continue to
`groW after being irnplanted. As stated above, the absorbable
`girdle stabiliZes the transplanted pulrnonary autograft for an
`extended period of time. The absorbable girdle, by its very
`nature, is sloWly absorbed. This permits the transplanted
`autograft, including the heart valve and corresponding tubu
`lar valve Wall, to groW With the patient.
`From the above description of the invention, those skilled
`in the art Will perceive irnprovernents, changes and rnodi
`?cations. Such irnprovernents, changes and rnodi?cations
`Within the skill of the art are intended to be covered by the
`appended claims.
`Having described the invention, the folloWing is claimed:
`1. A external support apparatus for supporting a heart
`valve disposed Within an elongated tubular valve Wall, the
`apparatus comprising:
`a girdle having an elongated sideWall With in?oW and
`out?oW ends spaced apart an axial length at least
`subtantially commensurate with axial length of the
`valve lea?ets of the heart valve;
`a stent disposed about the sideWall of the girdle interme
`diate the in?oW and out?oW ends of the sideWall of the
`girdle; and
`a sheath of biocornpatible rnaterial covering the stent and
`at least a portion of the girdle, the sheath having an
`in?oW edge adjacent the in?oW end of the sideWall of
`the girdle, the sheath having an out?oW edge spaced
`axially beyond an out?oW end of the stent.
`2. An apparatus as set forth in claim 1 Wherein a sinus is
`de?ned by each valve lea?et at an out?oW end of the heart
`valve, said girdle further including at least tWo apertures
`extending through said sideWall of said girdle spaced axially
`from the in?oW end of said girdle, each of said apertures
`being spaced circurnferentially apart for generally radial
`alignment with a corresponding one of the sinuses of the
`heart valve.
`3. An apparatus as set forth in claim 1 Wherein a portion
`of said sideWall of said girdle adjacent said in?oW end is
`folded toWard the out?oW end of said girdle and connected
`to said sideWall of said girdle, Whereby the folded portion
`may be connected at an in?oW end of the heart valve to
`inhibit dilation of the heart valve.
`4. An apparatus as set forth in claim 3 Wherein a sinus is
`de?ned by each valve lea?et at an out?oW end of the heart
`valve, said girdle further including at least tWo apertures
`extending through said sideWall of said girdle spaced axially
`from the in?oW end of said girdle, each of said apertures
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`NORRED EXHIBIT 2108 - Page 8
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`US 6,264,691 B1
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`9
`being spaced circurnferentially apart for generally radial
`alignment With a corresponding one of the sinuses of the
`heart valve.
`5. An apparatus as set forth in claim 1 Wherein the out?ow
`edge of said sheath is connected to said sideWall of said
`girdle intermediate the out?oW end of said stent and the
`out?oW end of said girdle.
`6. An apparatus as set forth in claim 1 Wherein said sheath
`is formed of an animal tissue material.
`7. An apparatus as set forth in claim 1 Wherein said sheath
`is formed of a textile material.
`8. An apparatus as set forth in claim 1 Wherein the out?oW
`end of said girdle has a plurality of lobes Which extend
`axially beyond said out?oW end of said stent so as to extend
`beyond an out?oW end of the heart valve.
`9. An apparatus as set forth in claim 1 Wherein said girdle
`is formed of an animal tissue material.
`10. An apparatus as set forth in claim 1 Wh