United States Patent
`Gabbay
`
`[19]
`
`US005935163A
`[11] Patent Number:
`[45] Date 0f Patent:
`
`5,935,163
`Aug. 10, 1999
`
`NATURAL TISSUE HEART VALVE
`PROSTHESIS
`
`Inventor: Shlomo Gabbay, Short Hills, N.J.
`
`Assïgneeï Shelhigh’InC(cid:173)>MÍHbum>N~J~
`
`APPL N03 09/052’707
`Filed.
`Man 31 1998
`’
`
`5,156,621 10/1992 Navia et al. .
`5,336,258
`8/1994 Quintero et al..
`5,549,665
`8/1996 Vesely et al. .
`
`FOREIGNPATENTDOCUMENTS
`2136533 9/1994 UnitedKingdom
`
`623/2
`
`Primary Examiner-David H. Wíllse
`Attorney, Agent, 0r Firm-Tarollí, Sundheím, Covell
`Tummíno & Szabo
`
`1541
`
`1751
`
`1731
`
`1211
`1221
`5
`5
`[58]
`
`[56]
`
`NORRED EXHIBIT 2107 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case IPR2014-00110
`
`

`
`U.S. Patent
`
`Aug. 10,1999
`
`Sheet 1 0f3
`
`5,935,163
`
`NORRED EXHIBIT 2107 - Page 2
`
`

`
`U.S. Patent
`
`Aug. 10,1999
`
`Sheet 2 0f3
`
`5,935,163
`
`NORRED EXHIBIT 2107 - Page 3
`
`

`
`U.S. Patent
`
`Aug. 10,1999
`
`Sheet 3 0f3
`
`5,935,163
`
`NORRED EXHIBIT 2107 - Page 4
`
`

`
`5,935,163
`
`1
`NATURAL TISSUE HEART VALVE
`PROSTHESIS
`
`TECHNICAL FIELD
`
`The present invention relates to a BIOS-prosthesis, and
`more particularly to a natural tissue heart valve prosthesis
`and a method for making the prosthesis.
`
`BACKGROUND OF THE INVENTION
`
`Numerous types of heart valve prostheses have been
`developed for replacing defective heart valves in human
`patients. One common type of heart valve prosthesis
`includes a natural tissue heart valve mounted Within a sent.
`The sent generally provides strength and rigidity to the heart
`valve. Typically, the sent is covered With a teXtile material,
`such as DacronTM, Which provides a substrate to Which the
`heart valve may be secured. While the sent provides desired
`rigidity and strength, Which inhibits the invvard deñection of
`the sent posts, it also decreases the hemodynamics of the
`valve. This is because the stent substantially increases the
`side Wall thickness of the prosthesis, Which reduces the siZe
`of the How orifice for a prosthesis having a given outer
`diameter. The teXtile covering also tends to abrade cusps of
`the valve.
`In order to overcome the disadvantages associated With
`the stented heart valve prosthesis, there has been an increas
`ing tendency to form natural tissue heart valve prostheses
`With no stent. These are called stentless valves. Stentless
`valves eXhibit improved hemodynamics and are less resis
`tant to blood ñovv. In addition, stentless valves, as compared
`to stented valves, are more resistant to structural failure
`because the rigidity of a stent can cause damage to the
`moving cusps. The improved hemodynamic characteristics
`of stentless valves also can cause beneficial remodeling of
`the heart muscle. Specifically, it has been determined that
`several months after implantation of a stentless valve in the
`aortic position, there is a noticeable improvement in the siZe
`of a left ventricle.
`Even though a stentless prosthesis offers improved results
`over its stented counterpart, in practice, conventional stent
`less prostheses have not been completely satisfactory. It
`requires a greater degree of surgical proficiency to implant
`a stentless prosthesis. It usually also requires additional time
`to perform the procedure. Accordingly, a very small number
`of surgeons are Willing to implant a stentless valve.
`There also are technical problems associated With the
`implantation of a typical natural tissue heart valve prosthesis
`having no stent. In general, a stentless prosthesis is deform
`able. Thus, if the aortic annulus is calcified, the implanted
`valve can be deformed and become dysfunctional. Such
`deformation of the valve might cause the cusps to be
`unleveled, resulting in inadequate coaptation of the cusps
`and backñovv. It also has been determined that the siZing of
`stentless valves is not Well defined for surgeons. Therefore,
`a siZing mismatch may occur, Which can cause the valve to
`be stenotic or insufficient.
`
`SUMMARY OF THE INVENTION
`
`The present invention is directed to a heart valve pros
`thesis that includes a natural tissue heart valve having a
`generally cylindrical side Wall portion eXtending betvveen an
`inñovv end and an outñovv end of the heart valve. The side
`Wall portion has an outer surface. The heart valve also
`includes a plurality of leañets disposed Within the side Wall
`portion of the valve. Each of the leañets has an associated
`
`10
`
`15
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`2
`side Wall portion and side edges. Adjacent side edges of
`adjacent leañets and adjacent portions of their respective
`associated side Wall portions define commissures. The heart
`valve prosthesis also includes an outer sheath of natural
`tissue covering the outer surface of the heart valve. The outer
`sheath has an outñovv end that eXtends beyond the outñovv
`end of the heart valve adjacent the commissures to define a
`plurality of lobes.
`Another feature of the present invention is directed to a
`method of making a heart valve prosthesis. The method
`includes the step of providing a heart valve having an inñovv
`end, an outñovv end, and a generally cylindrical side Wall
`portion eXtending betvveen the inñovv end and the outñovv
`end. The heart valve also includes a plurality of leañets
`disposed Within the side Wall portion. Each of the leañets has
`an associated side Wall portion and a pair of side edges, With
`adjacent side edges of adjacent leañets and adjacent portions
`of their respective associated side Wall portions defining
`commissures. The method also includes attaching an annular
`ring of a substantially ñeXible material about the side Wall
`portion of the valve positioned intermediate the inñovv and
`outñovv ends of the valve. A sheath of pericardial tissue
`covers the annular ring and the outer surface of the heart
`valve. The sheath has an inñovv end portion and an outñovv
`end portion. The outñovv end portion of the sheath is
`eXtended beyond the outñovv end of the heart valve to define
`a plurality of lobes adjacent the commissures.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`Preferred embodiments of the present invention are illus
`trated in the accompanying drawings, in Which:
`FIG. 1 is a perspective vievv of a heart valve used in an
`embodiment of the present invention;
`FIG. 2 is a perspective vievv of a ring used in an embodi
`ment of the present invention;
`FIG. 3 is another embodiment of a ring Which may be
`used as a substitute for the ring of FIG. 2;
`FIG. 4 is yet another embodiment of a ring;
`FIG. 5 is a perspective vievv illustrating the ring of FIG.
`3 attached to the heart valve of FIG. 1;
`FIG. 6 is a perspective vievv of an embodiment of a heart
`valve prosthesis in accordance With the present invention;
`FIG. 7 is a perspective vievv illustrating the ring of FIG.
`3 attached to a valve structure, Which may be used in another
`embodiment of the present invention; and
`FIG. 8 is a perspective vievv of another embodiment of a
`heart valve prosthesis in accordance With the present inven
`tion.
`
`DESCRIPTION OF PREFERRED
`EMBODIMENTS
`
`FIG. 1 illustrates a preferred embodiment of a natural
`tissue heart valve, generally indicated at 10. The heart valve
`10 includes an inñovv end 12, an outñovv end 14 and a central
`aXis, indicated at A, eXtending through the inñovv and
`outñovv ends 12 and 14, respectively. The valve 10 also has
`a generally cylindrical side Wall portion 16 formed of a valve
`Wall eXtending betvveen the inñovv end 12 and the outñovv
`end 14. The heart valve 10 also includes a plurality of
`leañets or cusps 18, 20 and 22 mounted Within the side Wall
`portion 16. Each of the leañets 18, 20 and 22 has a respective
`associated side Wall portion 24, 26 and 28 and respective
`pairs of opposed side edges 30 and 32, 34 and 36 and 38 and
`40. Adjacent pairs of side edges 30 and 40, 32 and 34, 36 and
`38 together With adjacent portions of their respective asso
`
`NORRED EXHIBIT 2107 - Page 5
`
`

`
`5,935,163
`
`3
`ciated side Wall portions 24, 26 and 28 define commissures,
`indicated at 42, 44 and 46. The heart valve 10 also sinuses
`48, 50 and 52 formed in the outñovv end 14 of the valve 10
`between adjacent commissures 42 and 44, 44 and 46, and 46
`and 42, respectively.
`The heart valve illustrated in FIG. 1 is a tri-composite
`natural tissue heart valve. In particular, each of the leañets
`18, 20 and 22 are selected to be of similar siZe, shape and
`symmetry. Matching the leañets 18, 20 and 22 in this manner
`generally provides an improved operation of the tri
`composite valve over complete heart valves, Which have
`asymmetric valve leañets.
`Preferably, each of the leañets 18, 20 and 22 is a non
`coronary leañet, suitably from an aortic porcine valve.
`Non-coronary leañets generally eXperience enhanced dura
`bility because of. the fibrous attachment of each leañet 18,
`20 and 22 to its respective valve Wall portion 24, 26 and 28.
`The leañets 18, 20 and 22 and associated valve Wall portions
`24, 26 and 28 may be eXcised from an appropriate valve,
`Which has been tanned or fiXed. For eXample, a valve may
`be fixed in a 0.3 to 0.5 glutaraldehyde solution at a tem
`perature ranging betvveen about 15o C. and 25° C. Apressure
`betvveen 0 and 4 millimeters mercury (HG) may also be
`applied to the outllovv end of a valve to maintain the leañets
`in a desired closed position.
`The side edges 30 and 32, 34 and 36, and 38 and 40 of the
`associated valve Wall portion 24, 26 and 28 of each respec
`tive leañet 18, 20 and 22 of the composite heart valve 10 are
`attached, suitably by sutures, to the side edges of each
`adjacent associated leañet, as shovvn in FIG. 1. The tri
`composite heart valve 10 should be assembled such that
`there is substantial coaptation, or generally aXial engage
`ment along the aXis A, betvveen each of the leallets 18, 20
`and 22 When in the closed position. This arrangement
`provides for substantially simultaneous opening and closing
`of the leañets 18, 20 and 22 to permit blood llovv through the
`valve 10 as Well as to inhibit blood backñovv.
`It Will be apparent to those skilled in the art that the
`composite heart valve 10 is similar in appearance and
`operation to a complete heart valve. Acomplete heart valve,
`such as an aortic porcine valve or other suitable heart valve,
`may also be used in connection With the present invention.
`Referring to FIG. 5, an annular ring 60 is positioned
`around the valve Wall 16 intermediate the inñovv and outñovv
`ends 12 and 14, respectively. Three alternative embodiments
`of suitable rings 60, 70 and 80 are illustrated in FIGS. 2, 3
`and 4, respectively. Each of the rings 60, 70 and 80 is formed
`of a substantially ñeXible and resilient material, preferably
`having maXimum memory to return to its original shape
`after being stressed. In general, the ring 60, 70 and 80
`stabiliZes the heart valve prosthesis during implantation.
`The ring 60, 70 or 80 also has a known outer diameter,
`suitably ranging in a variety of predetermined siZes. This
`provides an practical and accurate Way to determine the siZe
`of the resulting prosthesis. Based upon the siZe of the ring
`60, 70 or 80, a surgeon may select an appropriately siZed
`prosthesis for implantation Without a significant likelihood
`of a siZing mismatch betvveen the prosthesis and the patient.
`The ring 60 illustrated in FIG. 2 is formed of a synthetic
`resin material, Which may be a plastic material, such as
`DelrinTM. Preferably, the ring 60 has a radial thickness of
`less than about 0.5 millimeters. The ring 60 also has an inner
`diameter that approXimates the outer diameter of the heart
`valve 10 to Which it is attached, such that the ring 60 engages
`the side Wall portion 16. The ring 60 has an outñovv edge 62
`dimensioned and configured according to the contour of the
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`4
`outñovv end 14 of the valve 10. Specifically, the outñovv
`edge 62 of the ring 60 is sinusoidal having peaks 66, 67 and
`68 that are spaced apart circumferentially to correspond to
`the circumferential positioning and shape of the commis
`sures 42, 44 and 46. Preferably, the aXial length of the ring
`60 at the peaks 66, 67 and 68 is from about 1/3 to about Z/ß the
`aXial length of the valve 10 along the respective commis
`sures 42, 44 and 46. The ring 60 also has inllovv edge 64
`contoured according to the inllovv end 12 of the valve 10.
`The ring 60 is positioned coaXially around the valve 10,
`such as by sliding it over the side Wall portion 16. The ring
`60 is positioned intermediate the inllovv and outllovv ends 12
`and 14, respectively, as shovvn in FIG. 5. The respective
`inñovv and outñovv edges 64 and 62 of the ring preferably are
`spaced apart from the respective inñovv and outñovv ends 12
`and 14 of the valve 10. The peaks 66, 67 and 68 are aligned
`With the respective commissures 42, 44 and 46. Once in
`position, one or more sutures 69 may be applied to secure the
`ring 60 to the side Wall portion 16 of the valve 10.
`With respect to the embodiment of FIG. 3, the ring 70
`includes an outñovv edge 72 and an inñovv edge 74, Which
`are dimensioned and configured to correspond to the contour
`of the respective outñovv end 14 and inñovv end 12 of the
`heart valve 10 to Which it is to be attached. The outñovv edge
`72 of the ring 70 is preferably sinusoidal, With peaks 76, 77
`and 78 dimensioned and configured according to the com
`missures 42, 44 and 46 of the valve 10. In this embodiment,
`the ring 70 is formed of tvvo spaced apart layers 71 and 73
`of thin, ñeXible and resilient Wire. A plurality of aXially
`eXtending connecting rods 75 are connected betvveen the
`layers 71 and 73 to maintain the spaced apart relationship of
`the layers 71 and 73.
`The annular ring 80 shovvn in FIG. 4 is formed of a single
`layer of a thin, ñeXible and resilient Wire. The single layer
`ring 80 is dimensioned and configured to correspond to the
`dimensions and configuration of the outñovv end 14 of the
`valve 10 to Which it is to be attached. Specifically, the ring
`80 includes peaks 82, 84 and 86 dimensioned and spaced
`according to the commissures 42, 44 and 46 of the valve 10.
`The double layer ring 70 and the single layer ring 80 are
`attached to a heart valve 10 in a manner substantially
`identical to that shovvn and described With respect to FIG. 5.
`Each ring 70 or 80 Will be positioned around the outer
`surface of the valve Wall 16 With the peaks 76, 77 and 78 or
`82, 84 and 86 of the ring 70 or 80 aligned With a respective
`commissure 42, 44 and 46. The rings 70 or 80 should be
`positioned intermediate the respective outñovv and inllovv
`ends 14 and 12 of the valve 10, such as is shovvn in FIG. 5
`for the ring 60. Once appropriately positioned, the rings 70
`or 80 may be secured to the side Wall portion 16 of the valve
`10, suitably by one or more sutures.
`It Will be apparent to those skilled in the art that While
`three embodiments of rings 60, 70 and 80 are shovvn and
`described herein, other configurations of ring structures may
`also be used. It also Will be apparent that the peaks of each
`respective ring 60, 70 or 80 Will be substantially symmetri
`cal for a tri-composite valve, such as shovvn in FIG. 1, and
`asymmetrical for a complete valve (not shown).
`A preferred embodiment of a heart valve prosthesis 88 in
`accordance With the present invention is illustrated in FIG.
`6. A thin sheath 90 of natural tissue is applied over and
`covers the ring 60 and the side Wall portion 16 of the valve
`10. The sheath 90 preferably is formed of pericardium,
`suitably porcine or equine pericardium Which has been
`appropriately fixed in a glutaraldehyde solution. The sheath
`90 has an inllovv end portion 92 that eXtends beyond the
`
`NORRED EXHIBIT 2107 - Page 6
`
`

`
`5,935,163
`
`5
`inñovv end 12 of the heart valve 10 to define an implantation
`llange, indicated at 94. The sheath 90 also includes an
`outllovv end portion 96 having a plurality of ear-shaped
`ñanges or lobes 98, 100 and 102 eXtending beyond the
`outllovv end 14 of the valve 10. The lobes 98, 100 and 102
`eXtend a predetermined distance beyond and lateral to each
`of the commissures 42, 44 and 46 at the outllovv end 14 of
`the valve 10. The lobes 98, 100 and 102 preferably eXtend
`from about three to about four millimeters above the respec
`tive commissures and 42, 44 and 46. The lobes 98, 100 and
`102 might also eXtend a greater distance beyond each
`respective commissure 42, 44 and 46. The surgeon implant
`ing the prosthesis 88 may thus cut the lobes 98, 100 and 102
`to a desired shape and siZe. The particular siZe of the lobes
`98, 100 and 102 also Will depend upon the siZe of the
`prosthesis 88. Intermediate each of the lobes 98, 100 and
`102, the outllovv end 96 of the sheath 90 also follovvs the
`contour of the valve sinuses 48, 50 and 52. The sheath 90 is
`secured to outllovv end 14 of the valve 10, such as by a
`plurality of sutures 104. Similarly, the inñovv end 12 of the
`valve 10 may be secured to the sheath 90 by sutures 105.
`When implanting prosthesis 88, the lobes 98, 100 and 102
`may conveniently be sevvn to the aortic valve Wall of the
`patient. Consequently, the aortic valve Wall of the patient
`Will inhibit the invvard deñection of the commissures 42, 44
`and 46, thereby maintaining a desired shape of the prosthesis
`88. Preferably,the ring 60, 70 or 80 configured to be sub
`stantially lleXible, such that the ring cannot of its ovvn
`strength inhibit the dellection of the commissures 42, 44 and
`46 during closure of the leallets 18, 20 and 22.
`The sheath 90 also includes a pair of side edges that are
`secured edge to edge, suitably by sutures, to form an aXial
`seam 108. The seam 108 preferably is positioned in the
`middle of one leañet 28 intermediate adjacent commissures
`42 and 46.
`The sheath 90 also is secured about the ring 60, such as
`by sutures 106 sevvn through the sheath 90 and through the
`side Wall portion of the 16 of the side Wall portion valve
`along the inllovv and outllovv edges 62 and 64 of the ring 60.
`Preferably, “mattress sutures” 106 betvveen the sheath 90
`and the ring 60 are used to maintain the aXial positioning of
`the ring 60 intermediate the inñovv and outllovv ends 12 and
`14 of the heart valve 10, as shovvn in FIG. 6.
`An alternative embodiment of a heart valve prosthesis 128
`is shovvn in FIG. 8. FIG. 7 illustrates an intermediate step in
`the fabrication process of the prosthesis 128 of FIG. 8. The
`prosthesis 128 includes a natural tissue heart valve 130,
`Which may be substantially similar to the valve 10 shovvn
`and described With respect to FIG. 1.
`The heart valve 130 may be a complete heart valve or a
`composite heart valve, although a composite valve is pre
`ferred. The heart valve 130 includes an inñovv end 132, an
`outllovv end 134 and a generally cylindrical side Wall portion
`136 eXtending betvveen the inllovv end 132 and the outllovv
`end 134. The side Wall portion 136 is defined by the valve
`Wall portion of the heart valve 10. The heart valve has an
`aXis, indicated at B, eXtending through the inñovv and
`outllovv ends 132 and 134, respectively. The composite heart
`valve 130 also includes a plurality of similarly siZed, simi
`larly shaped and symmetrical leallets 138, 140 and 142.
`Each leañet 138, 140 and 142 has an associated side Wall
`portion 144, 146 and 148, respectively, Which define the side
`Wall portion 136. In the composite valve 130, adjacent
`leallets 138, 140 and 142 are attached at their adjacent side
`edges of the side Wall portions 144, 146 and 148, suitably by
`suture, to define commissures, indicated at 150, 152 and
`154. The heart valve 130 also includes sinuses 151, 153, and
`
`10
`
`15
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`6
`155 formed in the outllovv end 134 of the valve 130 betvveen
`adjacent respective commissures 150 and 152, 152 and 154,
`and 154 and 150.
`The prosthesis 128 includes a first sheath 160 of natural
`tissue, such as a thin sheet of equine or porcine pericardium,
`covering the outer surface of the valve 130 intermediate the
`inñovv and outllovv end portions 132 and 134, respectively.
`The first sheath 160 is secured to the side Wall portion 136,
`suitably by sutures (not shown), along at least a portion of
`the inllovv and outllovv ends 132 and 134 of the valve 130.
`Preferably, the first sheath 160 covers substantially the entire
`side Wall portion 136 of the valve 130, as shovvn in FIG. 7.
`An annular ring 162, Which, for eXample, can be one of
`the rings 60, 70 and 80 shovvn and described With respect to
`FIGS. 2, 3 and 4, is positioned coaXially around the first
`sheath 160 and the valve 130 and intermediate the inllovv
`and outllovv ends 132 and 134 of the valve 130. The ring 162
`includes an outllovv end 164 dimensioned and configured
`according to the contour of the outllovv end 134 of the valve
`130. More particularly, the ring 162 has a sinusoidal outllovv
`end 164 having peaks 166 and 170 spaced circumferentially
`to correspond to the respective commissures 150 and 154.
`The ring 162 also includes an inñovv end 165 contoured
`according to the inllovv end 132 of the valve 130. The ring
`162 is positioned around the valve 130, such that the aXial
`length of the ring 162 at the peaks 166 and 170 eXtends from
`about 1/3 to about Z/ß the aXial length of the heart valve 130
`at the respective commissures 150 and 154. The ring 162
`May be secured to the first sheath 160 by one or more
`sutures, indicated at 171. This Will maintain a desired aXial
`position of the ring 162 until additional sutures may be
`applied as described belovv.
`After the ring 162 has been applied to the valve 130 and
`the first sheath 160, a cylindrical outer sheath 172 of a
`natural tissue, such as a thin sheet of pericardium, is applied
`around valve structure of FIG. 7. Specifically, the outer
`sheath 172 covers the ring 162, the first sheath 160, and the
`eXposed side Wall portion 136 of the heart valve 130, as
`illustrated in FIG. 8. The outer sheath 172 has an inñovv end
`portion 174 that eXtends beyond the inllovv end 132 of the
`heart valve 130 to define an implantation llange, indicated at
`176. The outer sheath 172 also includes an outllovv end
`portion 178 having a plurality of lobes 182, 184 and 186
`eXtending beyond the outllovv end 134 of the valve 130. The
`lobes 182, 184 and 186, Which may be ear-shaped ñanges,
`preferably eXtend a predetermined distance beyond and
`lateral to each of the commissures 150, 152 and 154 at the
`outllovv end 134 of the valve 130. The outllovv end portion
`178 of the outer sheath 172 also follovvs the contour of the
`sinuses 151, 153 and 155 intermediate each of the commis
`sures 150, 152 and 154. The outer sheath 172 is secured to
`the valve 130 and the inner sheath 160 along the inllovv and
`outllovv ends 132 and 134 of the valve 130, suitably by
`respective sutures 179 and 180. The lobes 182, 184 and 186
`may conveniently be sevvn to the aortic valve Wall of the
`patient, thereby, inhibiting the invvard dellection of the
`commissures 150, 152 and 154 during operation of the
`prosthesis 128.
`The outer sheath 172 includes an aXial seam 188, Which
`is formed by suturing its ends together. The seam 188
`preferably is positioned in the middle of one leañet 142
`betvveen adjacent commissures 150 and 154. The outer
`sheath 172 also is secured to the side Wall portion 136 of the
`valve 130 and about the ring 162, such as by “mattress
`sutures” 190. The sutures 190 maintain the aXial positioning
`of the ring 162 spaced apart from and intermediate the
`respective inñovv and outllovv ends 132 and 134 of the heart
`valve 130.
`
`NORRED EXHIBIT 2107 - Page 7
`
`

`
`5,935,163
`
`7
`From the foregoing description it will be apparent to those
`skilled in the art that the present invention provides an
`improved heart valve prosthesis 88 or 128, which may be
`termed “semi-stentless.” The prosthesis 88 or 128 eXhibits
`hemodynamics comparable to known stentless valves. The
`lleXible ring 60, 70, 80 or 162 provides a “skeleton” to
`stabilize the prosthesis 88 or 128, without significantly
`increasing its side wall thickness. The ring 60, 70, 80 or 162
`also will resist deformation of the prosthesis 88 or 128 and
`promote desired coaptation of the leallets 18, 20 and 22 or
`138, 140 and 142. In addition, the prosthesis 88 or 128
`eXposes only natural tissue and sutures, thereby providing
`biocompatibility with the patient.
`From the above description of the invention, those skilled
`in the art will perceive improvements, changes and modi
`fications. Such improvements, changes and modifications
`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 heart valve prosthesis comprising:
`
`a natural tissue heart valve having an inllow end, an
`outllow end, and a generally cylindrical side wall
`portion eXtending between said inllow end and said
`outllow end, said valve including a plurality of leallets,
`each of said leallets having an associated side wall
`portion and side edges, adjacent side edges of adjacent
`said leallets and adjacent portions of respective said
`associated side wall portions defining commissures;
`an annular ring of a substantially lleXible material posi
`tioned around said valve wall intermediate said inllow
`and outllow ends; and
`a sheath of natural tissue attached around said valve wall
`and said ring, said sheath having an inllow end eXtend
`ing beyond said inllow end of said heart valve and
`defining an implantation llange, said sheath having an
`outllow end with a plurality of lobes eXtending beyond
`said outllow end of said heart valve.
`2. The heart valve prosthesis of claim 1 further compris
`ing a sinus formed in said outllow end of said valve between
`adjacent said commissures.
`3. The heart valve prosthesis of claim 2 wherein said
`outllow end of said sheath follows the contour of each of
`said sinuses.
`4. The heart valve prosthesis of claim 1 wherein said
`sheath is made of pericardium.
`5. The heart valve prosthesis of claim 1 wherein each of
`said lobes eXtends a predetermined distance beyond and
`lateral to each of said commissures at said outllow end of
`said heart valve.
`6. The heart valve prosthesis of claim 5 wherein each of
`said lobes comprises an ear-shaped llange.
`7. The heart valve prosthesis of claim 1 wherein said heart
`valve comprises a composite heart valve formed of three
`heart valve leallets of generally similar siZe, shape and
`symmetry, each said leallet including a valve wall portion
`having an inllow end, an outllow end and a pair of generally
`opposed side edges eXtending between the inllow and out
`llow ends, said side edges of each of said leallets being
`attached to said side edges of adjacent leallets such that there
`is substantial coaptation between said leallets, adjacent side
`edges of adjacent leallets defining said commissures, and
`said valve wall portions of said composite heart valve
`leallets defining said side wall portion of said heart valve.
`8. The heart valve prosthesis of claim 7 wherein each of
`said leallets is a non-coronary leallet of an aortic heart valve.
`
`10
`
`15
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`8
`9. The heart valve prosthesis of claim 1 wherein said ring
`comprises a plastic material having a substantially thin side
`wall portion.
`10. The heart valve prosthesis of claim 9 wherein said side
`wall portion of said ring has a thickness less than about 0.5
`mm.
`11. The heart valve prosthesis of claim 9 wherein said side
`wall portion of said ring has a substantially short aXial length
`relative to the aXial length of said side wall portion of said
`heart valve.
`12. The heart valve prosthesis of claim 1 wherein said ring
`comprises a resilient thin wire member.
`13. The heart valve prosthesis of claim 1 wherein said ring
`is sinusoidal with peaks corresponding to the contour of said
`outllow end of said heart valve, said ring being attached
`around said heart valve such that the aXial length of said ring
`at said peaks is less than about two-thirds the aXial length of
`said valve along corresponding said commissures.
`14. A heart valve prosthesis comprising:
`a natural tissue heart valve comprising:
`a generally cylindrical side wall portion eXtending
`between an inllow end and an outllow end, said side
`wall portion having an outer surface; and
`a plurality of leallets dispose&ed within said side wall
`portion, each of said leallets having side edges and an
`associated side wall portion, adjacent side edges of
`adjacent said leallets and respective adjacent portions
`of said associated side wall portions defining commis
`sures;
`an outer sheath of natural tissue covers said outer surface
`of said heart valve, said outer sheath having an outllow
`end portion eXtending beyond said outllow end of said
`heart valve adjacent said commissures to define a
`plurality of lobes.
`15. The heart valve prosthesis of claim 14 wherein said
`outer sheath further comprises an inllow end portion eXtend
`ing beyond said inllow end of heart valve to define an
`implantation llange.
`16. The heart valve prosthesis of claim 14 further com
`prising a substantially lleXible annular ring positioned
`around said outer surface of said side wall portion spaced
`from and intermediate said outllow end of said heart valve,
`said outer sheath covering said ring and said heart valve.
`17. The heart valve prosthesis of claim 16 further com
`prising sutures to maintain said ring positioned intermediate
`said inllow and outllow ends of said heart valve.
`18. The heart valve prosthesis of claim 17 wherein said
`sutures secure said ring to said outer sheath.
`19. The heart valve prosthesis of claim 17 wherein said
`sutures secure said ring to said side wall portion of said heart
`valve.
`20. The heart valve prosthesis of claim 16 wherein said
`ring has a sinusoidal outllow edge corresponding to the
`contour of said outllow end of said heart valve.
`21. The heart valve prosthesis of claim 16 further com
`prising a second sheath of natural tissue covering said side
`wall portion of said heart valve intermediate said ring and
`said heart valve, said second sheath eXtending between said
`inllow and outllow ends of said heart valve.
`22. The heart valve prosthesis of claim 14 wherein each
`of said lobes eXtends a predetermined distance beyond and
`lateral to each of said commissures at said outllow end of
`said heart valve.
`23. The heart valve prosthesis of claim 22 wherein each
`of said lobes comprises an ear-shaped llange.
`24. The heart valve prosthesis of claim 14 wherein said
`heart valve comprises a composite heart valve formed of
`
`NORRED EXHIBIT 2107 - Page 8
`
`

`
`5,935,163
`
`three heart valve leallets of generally similar siZe, shape and
`symmetry, each said leallet including a valve Wall portion
`having an inllovv end, an outllovv end and a pair of generally
`opposed side edges eXtending between the inllovv and out
`llovv ends, said side edges of each of said leallets being
`attached to said side edges of adjacent leallets such that there
`is substantial coaptation betvveen said leallets, adjacent side
`edges of adjacent leallets and associated valve Wall portions
`defining said commissures, and said valve Wall portions of
`said leallets defining said side Wall portion of said heart
`valve.
`25. A method of making a heart valve prosthesis com
`prising the steps of:
`providing a natural tissue heart valve having an inllovv
`end, an outllovv end, a generally cylindrical side Wall
`portion eXtending betvveen said inllovv end and said
`outllovv end, said heart valve including a plurality of
`leallets disposed Within said side Wall portion, each of
`said leallets having a pair of side edges and an asso
`ciated side Wall portion, adjacent side edges of adjacent
`said leallets and respective adjacent portions of said
`associated side Wall portions defining commissures;
`
`10
`
`15
`
`10
`positioning an annular ring of a substantially lleXible and
`resilient material around said side Wall portion inter
`mediate said inllovv and outllovv ends of said heart
`valve;
`covering said annular ring and said outer surface of said
`heart valve With a sheath of natural tissue, an sheath
`having an inllovv end portion and an outllovv end
`portion; and
`eXtending said outllovv end portion of said sheath beyond
`said outllovv end of said heart valve to define a plurality
`of lobes adjacent said commissures.
`26. The method of claim 25 further comprising the step of
`eXtending said inllovv end portion of said sheath beyond said
`inllovv