(12)
`
`United States Patent
`Carpentier
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 6,338,740 B1
`Jan. 15, 2002
`
`US006338740B1
`
`(54) FLEXIBLE HEART VALVE LEAFLETS
`
`(75) Inventor; Alain E Carpentier, Paris (FR)
`
`(73) Assigneez Edwards Lifesciences Corporation,
`Irvine C A (Us)
`’
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U_S~C_ 154(k)) by 0 days'
`
`( * ) Notice:
`
`(21) Appl. No.: 09/491,990
`_
`(22) Flledi
`Jan- 26, 2000
`_
`_
`Related U'S' Apphcatlon Data
`
`(63) Continuation-in-part of application No. 09/332,759, ?led on
`Jun. 14, 1999.
`(60) Provisional application No. 60/117,445, ?led on Jan. 26,
`1999-
`(51) Int. Cl.7 ............................. .. A61F 2/06; A61F 9/00
`(52) Us Cl
`623/2 13_ 623/212 623/904
`58
`F: I'd
`'
`’
`623/1 26 2 1
`(
`)
`1e
`18 964 ’91'0’
`’
`’ 929’
`
`iiiiii """"" ii
`0 gig/c2
`'
`
`’
`
`'
`
`’
`
`'
`
`’
`
`'
`
`’
`
`'
`
`9/1995 Johnson
`5,449,384 A
`2/1996 Duran
`5,489,297 A
`5,702,368 A * 12/1997 Stevens et al.
`5,861,028 A
`1/1999 Angell
`5,964,770 A * 10/1999 Flomenblit et al. ......... .. 606/78
`5,895,420 A
`4/2000 Mirsch, II et al.
`6,074,419 A
`6/2000 Healy et al.
`FOREIGN PATENT DOCUMENTS
`
`604/170.03 x
`
`WO 00/00107
`W0
`* cited by examiner
`
`1/2000
`
`Primary Examiner—Bruce SnoW
`Assistant Examiner—Brian E Pellegrino
`(74) Attorney, Agent, or Firm—Debra D. Condino; John
`Christopher James; Guy L. Cumberbatch
`
`(57)
`
`ABSTRACT
`
`A heart Valve With a structural stent and radially moveable
`cusps and commissures. The stent may be of three separate
`elements’ each having a Cusp portion and two commissure
`portions. The commissures may be pivotally or ?exibly
`coupled, and may separate into independent lea?ets. A
`connecting band may be provided that folloWs the cusps and
`commissures and extend outWardly. The valve may be
`connected to the natural tissue along the undulating con
`necting band. A multi-legged holder having legs alternating
`betWeen each cusp and commissure may be used for implan
`tation. A method of implantation is also disclosed, as is a
`system for implanting independent valve lea?ets in the
`native annulus.
`
`25 Claims, 18 Drawing Sheets
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`9/1981 Reul
`4,291,420 A
`6/1984 Carpentier et al.
`4,451,936 A
`9/1992 Lane
`5,147,391 A
`5,258,023 A * 11/1993 Reger ...................... .. 623/218
`
`402
`
`4/0 /
`
`4/0
`
`404
`
`400
`
`400
`
`402
`
`4/2
`
`NORRED EXHIBIT 2109 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case IPR2014-00110
`
`

`

`U.S. Patent
`
`Jan. 15,2002
`
`Sheet 1 0f 18
`
`US 6,338,740 B1
`
`VENTRICULAR SYSTOLE
`
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`47551219
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`__
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`U.S. Patent
`US. Patent
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`0 0 2
`1
`5,
`n. a J
`Jan.15,2002
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`US 6,338,740 B1
`US 6,338,740 B1
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`NORRED EXHIBIT 2109 - Page 12
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`

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`US 6,338,740 B1
`
`1
`FLEXIBLE HEART VALVE LEAFLETS
`
`RELATED APPLICATIONS
`
`The present application is a continuation-in-part of US.
`application Ser. No. 09/332,759, ?led Jun. 14, 1999, Which
`claims priority from Provisional Application No. 60/117,
`445, ?led Jan. 26, 1999, both having the same title.
`
`FIELD OF THE INVENTION
`
`The present invention relates to prosthetic heart valves,
`and, more particularly, to a prosthetic tissue valve having
`increased ?exibility enabling it to folloW the motions of the
`annulus and sinus regions.
`
`BACKGROUND OF THE INVENTION
`
`Prosthetic heart valves are used to replace damaged or
`diseased heart valves. In vertebrate animals, the heart is a
`holloW muscular organ having four pumping chambers: the
`left and right atria and the left and right ventricles, each
`provided With its oWn one-Way out?oW valve. The natural
`heart valves are identi?ed as the aortic, mitral (or bicuspid),
`tricuspid and pulmonary valves. The valves of the heart
`separate chambers therein, and are each mounted in an
`annulus therebetWeen. The annuluses comprise dense
`?brous rings attached either directly or indirectly to the atrial
`and ventricular muscle ?bers. Prosthetic heart valves can be
`used to replace any of these naturally occurring valves,
`although repair or replacement of the aortic or mitral valves
`are most common because they reside in the left side of the
`heart Where pressures are the greatest. In a valve replace
`ment operation, the damaged lea?ets are excised and the
`annulus sculpted to receive a replacement valve.
`The four valves separate each ventricle from its associated
`atrium, or from the ascending aorta (left ventricle) or pul
`monary artery (right ventricle). After the valve excision, the
`annulus generally comprises a ledge extending into and
`de?ning the ori?ce betWeen the respective chambers. Pros
`thetic valves may attach on the upstream or doWnstream
`sides of the annulus ledge, but outside of the ventricles to
`avoid interfering With the large contractions therein. Thus,
`for example, in the left ventricle a prosthetic valve is
`positioned on the in?oW side of the mitral valve annulus (in
`the left atrium), or on the out?oW side of the aortic valve
`annulus (in the ascending aorta).
`TWo primary types of heart valve replacements or pros
`theses are knoWn. One is a mechanical-type heart valve that
`uses a ball and cage arrangement or a pivoting mechanical
`closure to provide unidirectional blood ?oW. The other is a
`tissue-type or “bioprosthetic” valve Which is constructed
`With natural-tissue valve lea?ets Which function much like a
`natural human heart valve, imitating the natural action of the
`?exible heart valve lea?ets Which seal against each other to
`ensure the one-Way blood ?oW.
`Prosthetic tissue valves comprise a stent having a rigid,
`annular ring portion and a plurality of upstanding commis
`sures to Which an intact xenograft valve or separate lea?ets
`of, for example, bovine pericardium are attached. The entire
`stent structure is typically cloth-covered and a seWing ring
`is provided around the periphery for attaching to the natural
`annulus. Because of the rigidity of the material used in the
`stent and/or Wireform, conventional valves have a diameter
`that is minimally affected by the natural motion of the heart
`ori?ce. In the aortic position, the commissures extend in the
`doWnstream direction a spaced distance from the Walls of
`the doWnstream aortic Wall. Movement of the aortic Wall or
`
`10
`
`15
`
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`
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`
`2
`sinuses does not directly affect movement of the cantile
`vered commissures, though ?uid ?oW and pressures gener
`ated by movement of the Walls ultimately does cause the
`commissures to dynamically ?ex to some extent (i.e., they
`are cantilevered doWnstream in the aorta). Because of the
`inherent rigidity in conventional heart valves, the natural
`dilatation of the annulus is restricted, imposing an arti?cial
`narroWing of the ori?ce, and increasing the pressure drop
`therethrough.
`Accordingly, there is a need for a more ?exible heart
`valve that responds to the natural motions of the annulus and
`doWnstream vessel Walls.
`
`SUMMARY OF THE INVENTION
`The present invention alloWs the prosthesis to folloW the
`aortic Wall motion as Well as that of the annulus during
`systole and diastole phases, thus reducing the loss in pres
`sure caused by restriction of such motions. The solution is a
`heart valve having a plurality of lea?ets, preferably three,
`directly sutured to the aortic Wall, replacing the native valve.
`The present invention provides a heart valve including a
`?exible Wireform or stent that alloWs relative cusp move
`ment or pivoting. The continuous maintenance of lea?et
`orientation at the commissures provides durability and pre
`dictability. Though the lea?ets are not Wholly independent,
`they are alloWed to move in regions of greatest anatomical
`motion.
`The present invention differs in another respect from
`bioprosthetic tissue valves of the prior art because it does not
`include a conventional seWing ring With attendant rigid
`stent. Alternating peripheral cusps and commissures of the
`prosthetic valve are attached to the annulus region and the
`sinus region of the ascending aorta of the host (in the aortic
`valve version), doWnstream from the location of the natural
`lea?ets (typically excised).
`In accordance With one aspect of the present invention, a
`prosthetic heart valve is provided including a ?exible, gen
`erally cylindrical stent having alternating cusps and com
`missures. A plurality of ?exible lea?ets is attached to the
`stent so as to form a one-Way valve Within the cylinder. A
`?exible band is attached along the stent and has a free edge
`extending aWay from the stent along the alternating cusps
`and commissures for connecting the heart valve to an
`anatomical ori?ce.
`Another aspect of the present invention is a highly ?exible
`heart valve including a stent/lea?et subassembly having a
`peripheral stent and a plurality of lea?ets disposed there
`Within. The stent/lea?et subassembly de?nes alternating
`cusps and the commissures. Aconnecting band is attached to
`the stent/lea?et subassembly and folloWs the alternating
`cusps and commissures. The band includes a free edge
`extending from the stent for connecting the heart valve to an
`anatomical ori?ce.
`In a still further aspect of present invention, a prosthetic
`heart valve comprises a plurality of ?exible lea?ets, each
`having an arcuate cusp edge and a coapting edge. The heart
`valve includes a stent With a plurality of cusps connected to
`each other at upstanding commissures to generally de?ne a
`substantially cylindrical volume therebetWeen. The lea?ets
`are attached to the stent Within the cylindrical volume and
`the cusps are free to move With respect to one another about
`the commissures.
`In another embodiment, the present invention provides a
`prosthetic heart valve comprising a stent having a plurality
`of stent members adjacently disposed generally around a
`circle to de?ne a substantially cylindrical volume therebe
`
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`US 6,338,740 B1
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`3
`tween. The stent includes a plurality of alternating cusps and
`commissures. Preferably, the stent members each have a
`cusp and two commissure regions, with adjacent commis-
`sure regions of the stent members together defining each of
`the commissures of the stent. The stent members may be
`coupled together to pivot or flexibly move with respect to
`one another. The coupling may be permanent, or may
`comprise a bio-resorbable structure that permits the stent
`members and associated leaflets to move independently
`from one another.
`
`A further aspect of the invention is a heart valve having
`three leaflets which are directly sutured to the aortic wall,
`replacing the native valve. In one embodiment, the commis-
`sures of adjacent cusps may be connected during implant,
`and can become independent thereafter. This gives the cusps
`and commissures freedom to move during systole and
`diastole, thus improving the pressure gradient. To facilitate
`implantation, the commissures may be initially temporarily
`connected, such as with a biodegradable material. In a
`minimally invasive contexts,
`the valve may be partially
`collapsible to facilitate delivery through a narrow channel to
`the implantation site.
`Alternatively, the invention provides a reduced pressure
`gradient prosthetic heart valve that has multiple, preferably
`three, totally or partially independent leaflets. The leaflets
`are directly sutured to the aortic wall, replacing the native
`valve. The commissures of adjacent leaflets may be con-
`nected during implant and become independent thereafter, or
`they may be linked together at
`the commissure. For
`example, adjacent commissures may be linked by fasteners
`that are either unique to each leaflet (a commissure clip or
`a clip in conjunction with a cusp support), or comprise a
`continuous scalloped wire or frame around all of the leaflets.
`The fastener must be sufliciently flexible to preserve the
`motion of the three leaflets during systole. Because of the
`independent (or flexibly coupled) nature of the leaflets, the
`commissures are free to move during the systole/diastole
`cycle, and the pressure gradient through the valve is there-
`fore significantly reduced.
`Still further, the invention contemplates the replacement
`of a single leaflet with an independent prosthetic leaflet,
`while the other native leaflets remain and are still functional.
`
`That is, if one native leaflet is not functioning because of
`disease or other condition,
`the entire valve need not be
`replaced, just the damaged leaflet. The present invention
`thus enables a less invasive procedure that obviates the
`removal of healthy leaflets. Still further, a minimally-
`invasive implantation device may be used to deliver and
`implant the independent leaflet(s).
`Desirably, the stent of the prosthetic heart valve of the
`present invention is configured to permit
`the cusps and
`commissures to move radially in and out.
`In one
`embodiment, the stent comprises a cloth covered rod-like
`structure. The cloth covering closely surrounds the stent and
`includes a flap projecting therefrom substantially the entire
`length of the cusps and commissures for connecting the stent
`to both the flexible band and the leaflets. The band prefer-
`ably comprises a suture-permeable inner member, such as
`silicone, covered by cloth. The cusps of the stent may be
`pivotally or flexibly coupled to each other at the commis-
`sures. Preferably, the stent comprises separate cloth-covered
`stent members that each define a cusp region and two
`commissure regions, adjacent commissure regions of the
`stent members together defining each of the commissures of
`the stent. The commissure regions of the separate stent
`members desirably remain spaced apart, with the leaflets
`extending therethrough to be attached between the cloth
`
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`covering and the outer connecting band. In this manner, the
`leaflets are connected to separate stent members, and not to
`each other to facilitate flexing of the valve.
`In another aspect of the present invention, a holder is
`provided for mounting the flexible heart valve. The holder
`includes a central hub with a plurality of radially outward
`upper legs, and a plurality of lower legs angled downward
`and outward. The upper and lower legs are adapted to
`connect
`to the alternating cusps and commissures of a
`flexible valve so as to maintain the position of the valve
`during implantation.
`The present invention further provides a combination of a
`flexible prosthetic heart valve and a rigid holder. The flexible
`heart valve includes alternating cusps and commissures in a
`generally cylindrical configuration adapted to move radially
`in and out with respect to one another. The holder includes
`structure for maintaining a fixed shape of the flexible
`prosthetic heart valve during implantation.
`In a still further aspect of the present invention, a heart
`valve leaflet is provided comprising a flexible, planar body
`having an arcuate cusp edge terminating at outer tips. The
`planar body includes a coapting edge that is defined by two
`relatively angled lines joined at an apex directed away from
`the cusp edge midway between the two tips. Desirably, the
`leaflet is made of pericardial tissue.
`The present
`invention further provides a method of
`implantation of a heart valve, including the steps of: pro-
`viding a flexible heart valve having alternating cusps and
`commissures in a generally cylindrical configuration and
`adapted to move radially in out with respect to one another;
`attaching a holder to the valve that restricts relative move-
`ment of the cusps and commissures; positioning the heart
`valve in proximity to an anatomical orifice; implanting the
`heart valve; and, disconnecting the holder from heart valve.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a sectional view through the left half of a human
`heart showing a systolic phase of left ventricular contrac-
`tion;
`FIG. 2 is a sectional view through the left half of a human
`heart showing a diastolic phase of left ventricular expansion;
`FIG. 3 is an exploded perspective view illustrating sub-
`assemblies of a prosthetic heart valve of the present inven-
`tion;
`FIG. 4A is a top plan view of an internal stent of the
`prosthetic heart valve of the present invention;
`FIG. 4B is an elevational view of the internal stent of FIG.
`4A;
`FIG. 5 is an elevational view of a stent assembly of the
`prosthetic heart valve;
`FIGS. 6A and 6B are sectional views through two loca-
`tions of the stent assembly, taken along lines 6A—6A and
`6B—6B of FIG. 5;
`FIGS. 7A, 7B, and 7C are plan views of leaflets suitable
`for use in the prosthetic heart valve of the present invention;
`FIG. 8 is an exploded perspective view of a stent/leaflet
`sub-assembly and a connecting band of the prosthetic heart
`valve of the present invention;
`FIG. 9 is an elevational view of an inner member of the
`
`connecting band;
`FIG. 10 is a cross-sectional view through a cusp of the
`connecting band shown in FIG. 8;
`FIG. 11 is a perspective view of an assembled prosthetic
`heart valve of the present invention;
`
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`5
`FIG. 12A is a cross-sectional view through a cusp region
`of the prosthetic heart valve of the present invention, taken
`along line 12A—12A of FIG. 11, and showing a portion of
`the host annulus in phantom;
`FIG. 12B is a cross-sectional view through a commissure
`region of the prosthetic heart valve of the present invention,
`taken along line 12B—12B of FIG. 11, and showing a
`portion of the host aortic wall in phantom;
`FIG. 13 is a schematic view showing relative movement
`of the aortic and annulus walls during systolic flow;
`FIG. 14A is a plan view of only the stent members of the
`prosthetic valve flexed in accordance with the anatomical
`motions during systole shown in FIG. 13;
`FIG. 14B is an elevational view of the stent members
`
`flexed in accordance with the anatomical motions during
`systole shown in FIG. 13;
`FIG. 15 is a schematic view showing relative movement
`of the aortic and annulus walls during diastolic flow;
`FIG. 16A is a plan view of only the stent members of the
`prosthetic valve flexed in accordance with the anatomical
`motions during diastole shown in FIG. 15;
`FIG. 16B is an elevational view of the stent members
`
`flexed in accordance with the anatomical motions during
`diastole shown in FIG. 15;
`FIG. 17 is a perspective view of an alternative stent
`assembly for use in a prosthetic heart valve in accordance
`with the present invention;
`FIG. 18 is a perspective view of an internal stent of the
`stent assembly of FIG. 17;
`FIG. 19 is an exploded view of a commissure tip region
`of the stent assembly of FIG. 17;
`FIGS. 20A—20E are elevational views of alternative stents
`
`for use in a prosthetic heart valve in accordance with the
`present invention;
`FIG. 21 is a detailed view of a commissure region of the
`alternative stent of FIG. 20E;
`FIG. 22 is a detailed view of a commissure region of a still
`further alternative stent accordance with the present inven-
`tion;
`FIG. 23 is an exploded perspective view of the prosthetic
`heart valve of the present invention and a holder used during
`implantation of the valve;
`FIG. 24 is a perspective view of the holder coupled to the
`valve;
`FIG. 25 is a top plan view of the holder coupled to the
`valve;
`FIG. 26 is a cross-sectional view through the holder and
`valve, taken along line 26—26 of FIG. 25;
`FIGS. 27A and 27B are perspective views of an alterna-
`tive holder for the prosthetic heart valve of the present
`invention used during implantation of the valve;
`FIG. 28A is a perspective exploded view of an indepen-
`dent leaflet for use with other such leaflets that are attached
`
`directly to an ascending aorta and function together as a
`prosthetic valve;
`FIG. 28B is a perspective assembled view of the inde-
`pendent leaflet of FIG. 28A;
`FIG. 29A is an elevational view of one embodiment of an
`
`attachment structure between two of the adjacent indepen-
`dent leaflets of FIG. 28B;
`FIG. 29B is an elevational view of a continuous structure
`
`for attaching the independent leaflets of FIG. 28B;
`FIG. 30 is a perspective view of an exemplary device for
`measuring the native tissue prior to select the appropriate
`sized independent leaflet of FIG. 28B for implantation;
`
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`35
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`40
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`45
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`50
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`55
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`60
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`65
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`FIGS. 31A—31C are schematic views of a device for
`
`leaflet of the
`automatically implanting an independent
`present invention, illustrating a collapsible articulated holder
`especially suited for minimally invasive environments;
`FIGS. 32A—32C are schematic views of a further device
`
`for automatically implanting an independent leaflet of the
`present invention, illustrating a multi-part holder for install-
`ing attachment staples; and
`FIG. 33 is a cross-sectional view through one embodi-
`ment of an attachment structure for the independent leaflet
`embodiment, or for multi-leaflet embodiments for that mat-
`ter.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`The present invention provides a highly flexible aortic
`heart valve that is attached generally along a scalloped or
`undulating perimeter downstream from where the natural
`leaflets were originally attached. The natural leaflets include
`arcuate cusp portions separated by common commissure
`portions. If the natural valve has three leaflets, and has a
`vertically oriented flow axis, the leaflets are evenly distrib-
`uted circumferentially 120° apart with lower cusp portions
`and upstanding commissure portions. The commissure por-
`tions are connected between the cusp portions and are
`generally axially aligned along the aortic wall. The annular
`root of an aortic valve is composed of fibrous tissue and
`generally conforms to the undulating perimeter of the valve
`to support the leaflets. In this respect, implanting the aortic
`heart valve of the present invention involves excising the
`natural
`leaflets and attaching the prosthetic heart valve
`proximate the fibrous annulus, but also in part up the aortic
`wall. Because of the particular construction of the present
`heart valve, as will be described below,
`the attachment
`means, be it sutures, staples, adhesives, or otherwise, may be
`anchored into the aortic wall itself, adjacent to the fibrous
`annulus.
`
`Anatomy
`To better illustrate the advantages of the flexible heart
`valve of the present
`invention, an understanding of the
`movement of the annulus and aorta is helpful. In this regard,
`FIGS. 1 and 2 illustrate the two phases of left ventricular
`function; systole and diastole. Systole refers to the pumping
`phase of the left ventricle, while diastole refers to the resting
`or filling phase. FIGS. 1 and 2 illustrate in cross section the
`left chamber of the heart with the left ventricle 20 at the
`
`bottom, and the ascending aorta 22 and left atrium 24
`diverging upward from the ventricle to the left and right,
`respectively. FIG. 1 illustrates systole with the left ventricle
`20 contracting, while FIG. 2 illustrates diastole with the left
`ventricle dilating. The aortic valve 28 is schematically
`illustrated here as having leaflets 30. Contraction of the
`ventricle 20 causes the mitral valve 26 to close and the aortic
`
`valve 28 to open, and ejects blood through the ascending
`aorta 22 to the body’s circulatory system, as indicated in
`FIG. 1 by the arrows 32. Dilation of the ventricle 20 causes
`the aortic valves 28 to close and mitral valve 26 to open, and
`draws blood into the ventricle from the left atrium 24, as
`indicated in FIG. 2 by the arrows 33.
`The walls of the left chamber of the heart around the
`
`aortic valve can be generally termed the annulus region 34
`and the sinus region 36. The annulus region 34 generally
`defines an orifice that is the narrowest portion between the
`ventricle 20 and ascending aorta 22, which as noted above
`is composed of generally fibrous tissue. The sinus region 36
`is that area just downstream from the annulus region 34 and
`includes somewhat elastic, less fibrous tissue. Specifically,
`
`NORRED EXHIBIT 2109 - Page 22
`NORRED EXHIBIT 2109 - Page 22
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`US 6,338,740 B1
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`7
`the sinus region 36 typically includes three identifiable,
`generally concave sinuses (formally known as Sinuses of
`Valsalva) in the aortic wall
`intermediate the upstanding
`commissures of the valve 28. The sinuses are relatively
`elastic and are constrained by the intermediate, more fibrous
`commissures of the aortic annulus. Those of skill in the art
`
`will understand that the annulus region 34 and sinus region
`36 are not discretely separated into either fibrous or elastic
`tissue, as the fibrous commissures of the annulus extend into
`the sinus region 36.
`The sinuses tend to move in and out to facilitate fluid
`
`dynamics of the blood in conjunction with systole and
`diastole. During systole, as seen in FIG. 1, the sinus region
`36 expands somewhat to a diameter A. This facilitates blood
`flow through the ascending aorta 22 to the rest of the body.
`In contrast, during the diastolic phase as seen in FIG. 2, the
`sinus region 36 contracts somewhat to a smaller diameter B.
`The diameters A and B are intended to be a measurement of
`
`the radial movement of the commissure regions of the valve
`28. In this regard it will be understood that the cross-sections
`shown are not taken in a single plane, but instead are taken
`along two planes angled apart 120° with respect one another
`and meeting at the midpoint of the aorta 22. The sinus region
`36 has a neutral, or relaxed diameter (not shown) somewhere
`in between diameters A and B.
`
`The annular region 34 also moves in and out during the
`systolic and diastolic phases. As seen in FIG. 1, the annular
`region 34 contracts somewhat
`to a diameter C during
`systole. In contrast, during the diastolic phase as seen in
`FIG. 2, the annular region 34 expands somewhat to a larger
`diameter D. Much like the sinus region 36,
`the annular
`region 34 has a neutral, or relaxed diameter (not shown)
`somewhere in between diameters C and D.
`
`As will be explained more fully below, the prosthetic
`valve of the present invention accommodates the in and out
`movements of both the annular region 34 and the sinus
`region 36. That is, alternating peripheral portions of the
`prosthetic valve are attached to the annular region 34 and the
`sinus region 36 and move accordingly. It is important to
`point out that the preceding discussion of dynamic move-
`ment of the annulus and sinus regions is based on prelimi-
`nary understanding of such movement. That is, direct mea-
`surements of these movements are problematic, and thus
`certain assumptions and predictions must be made. The
`actual dynamic movement in any particular human heart
`may be different, but the principles of the present invention
`would still apply. That is, relative movement in the annulus
`and sinus regions during systole and diastole does exist, and
`the flexible prosthetic heart valve of the present invention
`can accommodate any such movement.
`Valve Subassemblies
`
`With reference now to FIG. 3, the primary sub-assemblies
`of a preferred embodiment of the prosthetic heart valve 40
`of the present invention are shown in exploded view. For
`purposes of discussion, the directions up and down, upper
`and lower, or top and bottom, are used with reference to FIG.
`3, but of course the valve can be oriented in any direction
`both prior to and after implantation. From top to bottom, the
`heart valve 40 comprises a group 41 of three leaflets 42,
`three angled alignment brackets 44, a stent assembly 46, and
`a connecting band 48. Each of the sub-assemblies seen in
`FIG. 3 is procured and assembled separately (except for the
`group of leaflets, as will be explained), and then joined with
`the other sub-assemblies to form the fully assembled valve
`40 as seen in FIG. 11.
`
`The prosthetic valve 40 is a trifoliate valve with three
`leaflets 42. Although three leaflets are preferred, and mimic
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`10
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`15
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`20
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`25
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`30
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`35
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`40
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`45
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`50
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`55
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`60
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`65
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`8
`the natural aortic valve, the principles of the present inven-
`tion can be applied to the construction of a prosthetic valve
`with two or more leaflets, depending on the need.
`Each of the sub-assemblies seen in FIG. 3 include three
`
`cusps separated by three commissures. The leaflets 42 each
`include an arcuate lower cusp edge 50 terminating in
`upstanding commissure regions 52. Each leaflet 42 includes
`a coapting or free edge 54 opposite the cusp edge 50. In the
`assembled valve 40,
`the cusp edges 50 and commissure
`regions 52 are secured around the periphery of the valve,
`with the free edges 54 permitted to meet or “coapt” in the
`middle. The stent assembly 46 also includes three cusps 60
`separated by three upstanding commissures 62.
`In like
`manner, the connecting band 48 includes three cusp portions
`64 separated by three upstanding commissure portions 66.
`Each of the sub-assemblies will now be described in detail.
`
`Stent Assembly
`Various components of a preferred stent assembly 46 are
`seen in FIGS. 4—6. The stent assembly 46 comprises an inner
`stent 70 and an outer cloth cover 72. More specifically, the
`inner stent 70 desirably includes three identical and separate
`stent members 74, each of which has a separate cloth
`covering. As seen best in FIG. 4B, each stent member 74
`comprises an arcuate lower cusp region 76 and upstanding
`commissure regions 78 each terminating at a tip 80. The
`stent members 74 comprise elongate rods or wires, prefer-
`ably made out of an elastic biocompatible metal and/or
`plastic alloy, such as Elgiloy®, Nitinol, polypropylene, etc..
`The material selected for stent members 74 should be elastic
`
`to permit flexing along their lengths, but should possess a
`relatively high modulus of elasticity to avoid asymmetric
`deformation of the constructed valve 40. The stent 70
`
`supplies an inner frame for the valve 40 that is relatively
`more rigid than the other components. Therefore, the stent
`70 acts to limit total flexibility of the valve 40.
`The stent members 74 are desirably bent into the illus-
`trated shape, using conventional wire-forming techniques.
`Each of the stent members 74 is identical, and terminates in
`the tips 80 which are bent inward with respect to the arcuate
`cusp regions 76 to nearly form closed circles. As is seen in
`FIG. 4B, a gradual radially outward bend 82 (with respect to
`the cylindrical stent 70) is provided in the stent members 74
`at a transition between each of the commissure regions 78
`and the intermediate cusp region 76. This bend 82 permits
`each of the stent members 74 to remain in a circular
`
`configuration, as seen from above in FIG. 4A. That is, if the
`cusp regions 76 extended in a plane between each of the
`commissure regions 78, the plan view would be somewhat
`triangular. Instead, each of the cusp regions 76 includes a
`lower apex 84