(12)
`
`United States Patent
`Schreck
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 6,454,799 B1
`Sep. 24, 2002
`
`US006454799B1
`
`(54) MINIMALLY-INVASIVE HEART VALVES
`AND METHODS OF USE
`
`5,571,174 A 11/1996 Love et a1.
`5,582,607 A 12/1996 Lackman
`
`(75) Inventor: Stefan Schreck, Vista, CA (US)
`
`(73) Assignee: Edwards Lifesciences Corporation,
`Irvine CA (Us)
`,
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`( * ) Notice:
`
`DE
`EP
`EP
`
`(Llst Connnued on next page)
`FOREIGN PATENT DOCUMENTS
`
`5/1993
`4316971 A1
`4/1988
`0103546 B1
`4/1993
`0362113 B1
`(List Continued on next page)
`
`OTHER PUBLICATIONS
`
`(21) Appl. No.: 09/549,413
`(22) Filed
`Apr 6 2000
`
`.
`
`.
`
`,
`
`(51) Int. c1.7 ................................................. .. A61F 2/24
`(52) US. Cl. .................... .. 623/2.18; 623/2.1; 623/2.14;
`623/2_17; 623/228; 623/2_33
`(58) Field Of Search ............................... .. 623/21, 2.14,
`623/217, 218, 238, 233, 223, 228
`
`(56)
`
`References Cited
`
`U'S' PATENT DOCUMENTS
`3,755,823 A * 9/1973 Hancock ................... .. 623/21
`3,839,741 A 10/1974 Haller
`4,056,854 A 11/1977 Boretos et al.
`4,084,268 A
`4/ 1978 IOIleSCll et @1-
`4>477>93O A 10/1984 Tone“ et al-
`4’gO6’394 A
`3/1985 Bed‘lird
`19232332 2
`gigoiirs
`4’994’077 A
`2/1991 Dobben
`50677957 A 11/1991 Jewis
`5,163,953 A 11/1992 Vince
`5,332,402 A
`7/1994 Teitelbaum
`5,370,685 A 12/1994 Stevens
`5,397,351 A
`3/1995 Pavcnik et 91-
`57411552 A
`5/1995 Andersen et a1~
`2
`g
`Eoume etl a1‘
`5’531’785 A
`7;1996 13:22:21‘
`5’545’209 A
`8/1996 Roberts et'al'
`5,545,214 A
`8/1996 Stevens
`5,549,665 A * 8/1996 Vesely ...................... .. 623/21
`5,554,185 A
`9/1996 Block et al.
`
`20
`
`Lane et al., Pub. No. US 2002/0026238 A1, Pub Date Feb.
`28, 2002, application 09/982,609.*
`
`(Llst Con?rmed on next page‘)
`Primary Examiner—corrine McDermott
`Assistant Examiner—Cheryl L. Miller
`(74) Attorney, Agent, or Firm—D9bra D- Condino; John
`Christopher James; Guy L. Cumberbatch
`57
`ABSTRACT
`(
`)
`Expandable heart valves for minimally invasive valve
`replacement surgeries are disclosed. In a ?rst embodiment,
`an @Xpandable rife-assembled heart Valve includes 4
`plastically-expandable annular base having plurality of
`upstanding commissure posts. A tubular ?exible member
`including a prosthetic section and a fabric section is
`provided, With the prosthetic section being connected to the
`commissure posts and de?ning lea?ets therebetWeen, and
`the fabric section being attached to the annular base. In a
`second embodiment, an expandable heart valve includes an
`annular tissue-engaging base and a subassembly having an
`elastic Wireform and a plurality of lea?ets connected thereto.
`The annular base and subassembly are separately stored and
`connected just prior to delivery to the host annulus.
`Preferably, the lea?et subassembly is stored in its relaxed
`con?guration to avoid deformation of the lea?ets. The
`expandable heart valves may be implanted using a balloon
`catheter. Preferably, the lea?ets of the heart valves are
`secured to the commissure regions of the expandable stents
`usm a c am in arran ement to re uce stress.
`' g
`1
`P' g
`g
`91
`
`20 Claims, 10 Drawing Sheets
`
`NORRED EXHIBIT 2299 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case No. IPR2014-00395
`
`Exhibit 1009 - Page 1
`
`

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`US 6,454,799 B1
`Page 2
`
`US. PATENT DOCUMENTS
`
`3/1997 Camilli
`5,607,465 A
`5,612,885 A * 3/1997 Love ........................ .. 623/2.1
`5,669,919 A
`9/1997 Sanders et a1.
`5,674,279 A 10/1997 Wright et al.
`5,682,906 A 11/1997 Sterman et al.
`5,695,515 A 12/1997 Orejola
`5,716,370 A
`2/1998 Williamson, IV et al.
`5,716,399 A
`2/1998 Love
`5,716,417 A * 2/1998 Girard ...................... .. 623/2.1
`5,728,153 A
`3/1998 Menkis et a1.
`5,824,064 A 10/1998 Taheri
`5,840,081 A 11/1998 Andersen et a1.
`5,855,601 A
`1/1999 Bessler et a1.
`5,855,603 A
`1/1999 Reif
`5,928,281 A * 7/1999 Huynh ..................... .. 623/21
`5,935,163 A * 8/1999 Gabbay .................... .. 623/2.1
`5,957,949 A
`9/1999 Leonhardt et a1.
`5,980,570 A 11/1999 Simpson
`5,984,959 A 11/1999 Robertson et 211.
`213331223 2 * 3/5888 g‘iihéialfafilj .......... .. 623/211
`6,264,691 B1 * 6/2001 Gabbay ______ __
`623/214
`6,336,937 B1 * H2002 Vonesh et a1_
`623/113
`6,338,740 B1 * 1/2002 Carpentier
`623/213
`6,350,282 B1 * 2/2002 Eberhardt ................ .. 623/213
`2001/0002445 A1
`5/2001 Vesely
`2001/0007956 A1
`7/2001 Letfic et al-
`2001/0021872 A1
`9/2001 Balley et a1‘
`FOREIGN PATENT DOCUMENTS
`
`EP
`EP
`EP
`EP
`
`5/1996
`0532678 B1
`0804911 A2 11/1997
`0850607 A1
`7/1998
`1 057 460 A1 12/2000
`
`EP
`SU
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`WO
`W0
`WO
`WO
`W0
`WO
`W0
`WO
`
`1 088 529 A2
`1621912 A1
`WO 96/19159
`W0 96/40006
`WO 97/09947
`W0 97/O9949
`WO 97/46177
`W0 9960646
`WO 99/33414
`WO 99/53869
`WO 99/56665
`00/41652
`OO/44313
`00/45874
`00/47139
`00/453533
`01/52775 A1
`0154625 A1
`01/56512 A1
`
`4/2001
`2/1989
`6/1996
`12/1996
`3/1997
`3/1997
`12/1997
`6/1999
`7/1999
`10/1999
`11/1999
`7/2000
`8/2000
`8/2000
`8/2000
`8/2000
`7/2001
`8/2001
`8/2001
`
`OTHER PUBLICATIONS
`Rntnn, 6W1» Bnnnntnnnn Snnnnn An Intnnnnntnnn tn
`Materials in Medicine, Academic Press, 1996, p. 289*
`Grrsmer, et al.; A Suture Holder and Separator Attachment
`to the Starr—Edwards Prosthetic Valve Holders, Surgery,
`Gynecology & Obstetrics, pp. 583—584, Mar. 1965.
`Pavcnick, et al.; Development and Initial Experimental
`Evaluation of a Prosthetic Aortic Valve for Transcatheter
`Placement, Cardiovascular Radiology, vol. 183, No. 1, pp.
`151—154
`Bailey Percutaneous Expandable Prosthetic Valves, VIII—
`Valvuloplasty, Congenital and Pericardial Heart Disease, pp.
`1269_1276~
`
`* cited by examiner
`
`NORRED EXHIBIT 2299 - Page 2
`
`

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`U.S. Patent
`
`Sep. 24, 2002
`
`Sheet 1 0f 10
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`US 6,454,799 B1
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`Fig. 1
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`20<
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`v.
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`NORRED EXHIBIT 2299 - Page 3
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`Sep. 24, 2002
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`NORRED EXHIBIT 2299 - Page 4
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`Sep. 24, 2002
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`g
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`NORRED EXHIBIT 2299 - Page 5
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`Sep. 24, 2002
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`Sheet 4 0f 10
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`‘N w
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`NORRED EXHIBIT 2299 - Page 6
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`Sep. 24, 2 2
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`NORRED EXHIBIT 2299 - Page 7
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`Sep. 24, 2002
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`J11O
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`Sep. 24, 2002
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`Sep. 24, 2002
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`Sep. 24, 2002
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`Sep. 24, 2002
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`

`
`US 6,454,799 B1
`
`1
`MINIMALLY-INVASIVE HEART VALVES
`AND METHODS OF USE
`
`FIELD OF THE INVENTION
`
`The present invention relates generally to medical devices
`and particularly to expandable heart valve prostheses espe
`cially for use in minimally-invasive surgeries.
`
`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 valve. The natural heart
`valves are identi?ed as the aortic, mitral (or bicuspid),
`tricuspid and pulmonary valves. Prosthetic heart valves can
`be used to replace any of these naturally occurring valves,
`although repair or replacement of the aortic or mitral valves
`is most common because they reside in the left side of the
`heart Where pressures are the greatest.
`Where replacement of a heart valve is indicated, the
`dysfunctional valve is typically cut out and replaced With
`either a mechanical valve, or a tissue valve. Tissue valves are
`often preferred over mechanical valves because they typi
`cally do not require long-term treatment With anticoagulants.
`The most common tissue valves are constructed With Whole
`porcine (pig) valves, or With separate lea?ets cut from
`bovine (coW) pericardium. Although so-called stentless
`valves, comprising a section of porcine aorta along With the
`valve, are available, the most Widely used valves include
`some form of stent or synthetic lea?et support. Typically, a
`Wireform having alternating arcuate cusps and upstanding
`commissures supports the lea?ets Within the valve, in com
`bination With an annular stent and a seWing ring. The
`alternating cusps and commissures mimic the natural con
`tour of lea?et attachment. Importantly, the Wireform pro
`vides continuous support for each lea?et along the cusp
`region so as to better simulate the natural support structure.
`A conventional heart valve replacement surgery involves
`accessing the heart in the patient’s thoracic cavity through a
`longitudinal incision in the chest. For example, a median
`sternotomy requires cutting through the sternum and forcing
`the tWo opposing halves of the rib cage to be spread apart,
`alloWing access to the thoracic cavity and heart Within. The
`patient is then placed on cardiopulmonary bypass Which
`involves stopping the heart to permit access to the internal
`chambers. Such open heart surgery is particularly invasive
`and involves a lengthy and dif?cult recovery period.
`Recently, a great amount of research has been done to
`reduce the trauma and risk associated With conventional
`open heart valve replacement surgery. In particular, the ?eld
`of minimally invasive surgery (MIS) has exploded since the
`early to mid-1990s, With devices noW being available to
`enable valve replacements Without opening the chest cavity.
`MIS heart valve replacement surgery still requires bypass,
`but the excision of the native valve and implantation of the
`prosthetic valve are accomplished via elongated tubes or
`cannulas, With the help of endoscopes and other such
`visualiZation techniques.
`Some examples of MIS heart valves are shoWn in US.
`Pat. No. 5,980,570 to Simpson, U S. Pat. No. 5,984,959 to
`Robertson, et al., and PCT Publication No. WO 99/334142
`to Vesely. Although these and other such devices provide
`various Ways for collapsing, delivering, and then expanding
`a “heart valve” per se, none of them disclose an optimum
`structure for tissue valves. For instance, the publication to
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`Vesely shoWs a tissue lea?et structure of the prior art in FIG.
`1, and an expandable inner frame of the invention having
`stent posts in FIGS. 3A—3C. The lea?ets are “mounted to the
`stent posts 22 in a manner similar to that shoWn in FIG. 1.”
`Such a general disclosure stops short of explaining hoW to
`construct an optimum valve. In particular, the means of
`attaching the lea?ets to the MIS stent is critical to ensure the
`integrity and durability of the valve once implanted. All of
`the prior art MIS valves fall short in this regard.
`In vieW of the foregoing, it is evident that an improved
`seWing ring that addresses the apparent de?ciencies in
`existing expandable heart valves is necessary and desired.
`
`SUMMARY OF THE INVENTION
`
`The present invention provides an expandable prosthetic
`heart valve for placement in a host heart valve annulus,
`comprising an expandable stent system adapted to be deliv
`ered in a collapsed state to an implantation site and
`expanded, and a plurality of prosthetic lea?ets attached to
`the stent system. Each lea?et has an approximately semi
`circular cusp edge terminating at each end in commissure
`portions, and a coapting edge extending betWeen the com
`missure portions. Each lea?et is attached to the stent system
`substantially entirely along the cusp edge and at both
`commissure portions, With a coapting edge remaining unat
`tached. The stent system may comprise an expandable
`generally annular tissue-engaging base and an elastic gen
`erally annular Wireform attached thereto. The base is
`adapted to be delivered in a radially collapsed state and
`expanded into contact With the host annulus. The annular
`Wireform de?nes a plurality of upstanding commissures and
`a plurality of arcuate cusps betWeen adjacent commissures,
`and the prosthetic lea?ets are attached to the Wireform along
`the cusps and commissures, Wherein the Wireform and
`lea?ets are con?gured to be radially compressed.
`In one embodiment, the heart valve includes a plurality of
`upstanding posts attached to one of the tissue-engaging base
`and elastic Wireform, each post having a connector. A
`plurality of mating connectors are provided on the other of
`the tissue-engaging base and elastic Wireform for mating
`With the post connectors. The posts and mating connectors
`may be provided for each commissure and each cusp of the
`elastic Wireform so that the valve includes a number of posts
`and mating connectors equal to the number of commissures
`plus the number of cusps. Further, the expandable stent
`system may include an undulating Wireform de?ning a
`plurality of commissures and a plurality of cusps betWeen
`adjacent commissures. The cusp edge of each of the pros
`thetic lea?ets attaches along a Wireform cusp, and the
`commissure portions of each lea?et terminate in outWardly
`extending tabs that each attach to a Wireform commissure,
`Wherein tabs from adjacent lea?ets are attached together at
`each of the Wireform commissures.
`In another aspect of the invention, an expandable pros
`thetic heart valve for placement in a host heart valve annulus
`is provided. The heart valve comprises an expandable stent
`portion and an elastic lea?et portion connectable to the stent
`portion. The stent portion de?nes an in?oW end of the valve
`and is adapted to be delivered in a collapsed state and
`expanded into contact With the host annulus. The lea?et
`portion forms a one-Way ?oW occluder on an out?oW end of
`the valve and includes an elastic Wireform de?ning alter
`nating cusps and commissures and prosthetic tissue attached
`substantially entirely therealong. The stent portion desirably
`includes a tubular member and a plurality of connectors, and
`Wherein a plurality of connectors are provided on the elastic
`
`NORRED EXHIBIT 2299 - Page 13
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`US 6,454,799 B1
`
`3
`Wireform for mating With the tubular member connectors.
`The Wireform connectors may be provided on each com
`missure and on each cusp of the Wireform so that the valve
`includes a number of mating connectors equal to the number
`of commissures plus the number of cusps. In a preferred
`embodiment, the prosthetic tissue comprises a plurality of
`individual lea?ets secured along the alternating cusps and
`commissures of the elastic Wireform. Additionally, the Wire
`form may have a fabric covering, Wherein the individual
`lea?ets are stitched along the fabric covering. The fabric
`covering continues toWard an in?oW end of the valve in a
`skirt that surrounds the stent portion and is adapted to be
`captured betWeen the expanded stent portion and the host
`annulus. Aplurality of posts rigidly may connect to the stent
`portion and extend upWard Within the skirt into mating
`connection With the elastic Wireform.
`In a still further aspect, the present invention provides a
`tWo-part expandable prosthetic heart valve for placement in
`a host heart valve annulus, comprising:
`a lea?et subassembly having a Wireform de?ning a plu
`rality of upstanding commissures and a plurality of
`arcuate cusps extending betWeen adjacent
`commissures, a midpoint of each cusp being located
`approximately equidistant from the adjacent commis
`sures;
`a generally annular tissue-engaging base de?ning an axis;
`and
`a system for connecting the lea?et subassembly and the
`tissue-engaging base, including a plurality of mating
`connectors on the lea?et subassembly and on the tissue
`engaging base, Wherein one connector each is provided
`at each commissure, and one at each cusp midpoint.
`In the tWo-part heart valve, the tissue-engaging base
`preferably comprises an expandable tubular member that is
`deliverable to the host annulus in a collapsed state and
`expandable into contact With the host annulus to secure the
`valve therein. Furthermore, the tissue-engaging base forms
`an in?oW end of the valve, and the system for connecting the
`lea?et subassembly and tissue-engaging base includes a
`plurality of posts coupled to the tubular member and having
`varying lengths extending aWay from the in?oW end of the
`valve. A ?rst plurality of posts each having a ?rst length
`connects With the Wireform commissures, and a second
`plurality of posts each having a second length connects With
`the Wireform cusps shorter than the ?rst length. The mating
`connectors may be con?gured to be joined together by axial
`compression, preferably With a snap-?t con?guration.
`A further aspect of the invention includes a prosthetic
`heart valve having a support stent and a ?exible tubular
`member. The support stent includes a tubular base along an
`in?oW end a plurality of generally axially-extending com
`missure posts disposed evenly around the tubular base on an
`out?oW end thereof. The ?exible tubular member has a
`prosthetic section attached to the commissure posts so as to
`de?ne a plurality of the prosthetic valve lea?ets betWeen the
`posts, and a fabric section connected to the base. The
`prosthetic section and fabric section are desirably both
`generally tubular and attached together at a seam, Wherein
`the seam is spaced from the out?oW end of the tubular base
`so that only the fabric section of the ?exible tubular member
`contacts the tubular base. The commissure posts each may
`have an axial slot, Wherein the tubular member is primarily
`located Within the posts except for a plurality of loops that
`extend outWard through each slot on each post. A plurality
`of inserts siZed larger than the slots may be provided, each
`of Which insert is captured Within a loop extending outWard
`through each slot to retain the loop through the slot. In a
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`preferred embodiment, the commissure posts are integrally
`formed With the base, the base and commissure posts being
`initially formed from a ?at section of material, Wherein the
`commissure posts initially extend from the in?oW end of the
`base and are bent 180° to extend alongside the base and
`project beyond the base at the out?oW end thereof.
`A prosthetic heart valve of the present invention has a
`support stent including a tubular base along an in?oW end.
`Aplurality of generally axially-extending commissure posts
`each having an axial slot is disposed evenly around the
`tubular base on an out?oW end thereof. A ?exible tubular
`member having an out?oW edge is primarily located Within
`the posts except for a plurality of loops that extend outWard
`through each slot on each post. Further, a plurality of inserts
`siZed larger than the slots are provided, each of Which insert
`is captured Within a loop extending outWard through each
`slot to retain the loop through the slot, the out?oW edge of
`the tubular member de?ning a plurality of valve lea?ets. The
`tubular base may be plastically-expandable from a ?rst siZe
`adapted for minimally invasive delivery, to a second, func
`tional siZe that ?ts Within a heart valve annulus.
`A method of minimally-invasive heart valve replacement
`surgery on a patient is also provided by the present inven
`tion. The method includes the steps of:
`providing an annular tissue-engaging base, the base being
`expandable from a collapsed state;
`providing a generally annular elastic Wireform subassem
`bly having a plurality of prosthetic lea?ets connected
`thereto, the elastic Wireform subassembly having a
`relaxed, expanded siZe and a compressed, reduced siZe;
`connecting the Wireform and lea?ets to the base to form
`a heart valve;
`delivering the heart valve With the connected base in its
`collapsed state and Wireform subassembly in its
`reduced siZe to an annulus of the patient’s heart valve
`being replaced; and
`expanding the base into its expanded state in contact With
`the annulus.
`The step of delivering the heart valve to the annulus may
`be accomplished by passing the valve through the patient’s
`vasculature or via a minimally-invasive port in the patient’s
`chest. The tissue-engaging base may plastically-expandable
`from its collapsed state to its expanded state, and the step of
`expanding the plastically-expandable base comprises in?at
`ing a balloon Within the annular base.
`A further understanding of the nature and advantages of
`the invention Will become apparent by reference to the
`remaining portions of the speci?cation and draWings.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is an exploded perspective vieW of a ?rst embodi
`ment of an expandable heart valve of the present invention,
`including a support stent and a ?exible tubular member;
`FIG. 2 is an assembled perspective vieW of the expand
`able heart valve of FIG. 1;
`FIG. 3 is a longitudinal cross-sectional vieW taken along
`line 3—3 through a commissure of the expandable heart
`valve of FIG. 2;
`FIG. 4 is a transverse cross-sectional vieW taken along
`line 4—4 through the commissure of the expandable heart
`valve of FIG. 2;
`FIG. 5 is a top plan vieW of the expandable heart valve of
`FIG. 2;
`FIG. 6 is an exploded perspective vieW of a second
`embodiment of an expandable heart valve of present inven
`
`NORRED EXHIBIT 2299 - Page 14
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`US 6,454,799 B1
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`5
`tion having tWo detachable components designed to be
`assembled post-storage, including a tissue-engaging base
`and a Wireform-supported lea?et subassembly;
`FIG. 7 is an assembled perspective vieW of the expand
`able heart valve of FIG. 6, With a fabric skirt removed to
`illustrate details of a connecting system betWeen the base
`and lea?et subassembly;
`FIG. 8 is a plan vieW of an insert used to both attach
`individual lea?ets to commissures of the Wireform, and
`connect the commissures of the lea?et subassembly to the
`tissue-engaging base of the expandable heart valve of FIG.
`6;
`FIG. 9 is a plan vieW of an individual lea?et for use in the
`expandable heart valve of FIG. 6;
`FIG. 10 is a longitudinal cross-sectional vieW taken along
`line 10—10 of FIG. 7;
`FIG. 11 is a transverse cross-sectional vieW taken along
`line 11—11 of FIG. 7;
`FIG. 12 is a longitudinal cross-sectional vieW taken along
`line 12—12 of FIG. 7;
`FIG. 13 is a top plan vieW of the expandable heart valve
`taken along line 13—13 of FIG. 7;
`FIG. 14 is an enlarged perspective vieW of a commissure
`region of the expandable heart valve taken Within the circle
`14 of FIG. 7;
`FIG. 15 is an enlarged plan vieW of the commissure region
`of the expandable heart valve taken Within the circle 15 of
`FIG. 13; and
`FIGS. 16A—C illustrate a heart in section and several steps
`in a delivery and implantation procedure of the expandable
`valve of the present invention.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`The present invention discloses tWo different expandable
`heart valves for implantation in a host annulus, or host tissue
`adjacent the annulus. The valves may be implanted in any of
`the four valve positions Within the heart, but are more likely
`to be used in replacing the aortic valve because of the
`circular shape of the annulus.
`It should also be noted that the speci?c constructional
`details, including materials and shapes, may be varied from
`those shoWn. For example, an expandable tubular base is
`used in both valve embodiments, and is described as being
`a plastically-expandable structure that radially expands into
`contact With the annulus tissue. Alternatively, the tubular
`base may be elastically- or self-expandable, or expandable
`on the application of heat (i.e., using shape memory
`material). Further, various means are knoWn for plastically
`or elastically expanding structures into contact With ana
`tomical passageWays, and though the present invention
`illustrates and describes only one such structure, others may
`be used to practice the invention. For example, any
`plastically- or elastically-expandable structure may be modi
`?ed so as to have a suitable diameter for heart valves and
`used to practice the present invention. In addition, barbs,
`?anges, staples, and the like may be added to the tubular
`base for the purpose of greater attachment to the host tissue.
`In short, the present invention should not be construed to be
`limited to the particular structures and materials disclosed,
`the scope of the invention being solely de?ned by the
`appended claims.
`With reference to FIGS. 1—5, a ?rst embodiment of an
`expandable prosthetic heart valve 20 is shoWn and
`described. The prosthetic heart valve 20 is assembled prior
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`to storage. In a second embodiment, shoWn in FIGS. 6—15,
`a second embodiment of an expandable heart valve is shoWn
`and described. Detachable components of the expandable
`heart valve in the second embodiment are separately stored,
`and assembled just prior to insertion and delivery to the host
`annulus, Which provides certain advantages to be described.
`Pre-Assembled Expandable Heart Valve
`FIG. 1 illustrates the ?rst embodiment of the expandable
`heart valve 20 exploded, With a ?exible tubular member 22
`separated from a support stent 24 along a central axis 26.
`FIG. 2 illustrates the ?exible tubular member 22 attached to
`the support stent 24 to form the assembled heart valve 20.
`The heart valve 20 has an in?oW end 28 (the loWer end in
`the ?gure) and an out?oW end 30 (the upper end in the
`?gure).
`The ?exible tubular member 22 comprises a lea?et sec
`tion 32 connected to a fabric section 34 at a seam 36. As
`illustrated, both the lea?et section 32 and fabric section 34
`are desirably formed as tubes, such that the seam 36 de?nes
`a circle therebetWeen. Alternatively, the seam 36 may be
`other than circular if areas of the lea?et section 32 or fabric
`section 34 need to be expanded around their circumferential
`juncture. For example, the fabric section 34 may need to be
`increased in the commissure region of the valve 20, such as
`indicated by the dashed line 38 in FIG. 1. Whatever the
`con?guration, the fabric section 34 has a minimum axial
`height indicated at A.
`Desirably, the lea?et section 32 is formed from pericardial
`tissue, such as bovine or equine pericardium, suitably treated
`to render it biocompatible. Of course, any suitable lea?et
`material, including synthetics, may be used. The fabric
`section 34 is desirably a Woven polyester, such as polyeth
`ylene terepthalate. Alternatively, the fabric section 34 may
`be formed of polytetra?uoroethylene (PTFE), or other suit
`able biocompatible sheet material. Still further, the lea?et
`section 32 may extend the entire axial height of the ?exible
`tubular member 22, With the fabric section 34 being Wrapped
`around and attached to the in?oW end.
`As seen in FIG. 1, the support stent 24 comprises a tubular
`base 40 and a plurality of upstanding commissure posts 42
`distributed evenly around the periphery thereof. That is, the
`tubular base 40 is provided at the in?oW end 28 of the
`support stent 24, With the commissure posts 42 extending in
`the out?oW direction. Desirably, there are three such com
`missure posts 42 disposed at 120° intervals about the cir
`cumference of the stent 24. The tubular base 40 has an axial
`height indicated at B, Which height is less than the axial
`height A of the fabric section 34 of the ?exible tubular
`member 22. The commissure posts 42 extending upWard a
`suf?cient distance such that the entire axial dimension of the
`support stent 24 is slightly greater than the axial dimension
`of the ?exible tubular member 22, as indicated in the
`assembled vieW of FIG. 2.
`The tubular base 40 comprises a plastically-expandable
`material that can be expanded into the con?guration shoWn
`in the ?gures from a radially compressed con?guration (not
`shoWn). In this regard, the illustrated tubular base 40 essen
`tially comprises a non-self expanding stent that can be
`expanded from its compressed state using a balloon in?ated
`from Within the base, for example. Numerous con?gurations
`of such plastically-expandable tubes are available in the
`prior art, and as mentioned above, the present invention
`should not be considered limited to any one con?guration.
`Moreover, in other con?gurations the base 40 may be self
`or heat-expandable.
`With reference to FIG. 1, each commissure post 42
`attaches to or extends from an in?oW rim 44 of the tubular
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`NORRED EXHIBIT 2299 - Page 15
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`US 6,454,799 B1
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`base 40, continuing on the outside of the tubular base toward
`the out?ow end in an elongated axially-extending lower
`section 46, and terminating in an axially extending upper
`section 48. The upper section 48 commences at a predeter
`mined distance above an out?ow rim 50 of the tubular base
`40 and is stepped radially inward from the lower section 46
`at a transition region 52. An axial slot 54 is provided in the
`upper section 48 and in the transition region 52. The width
`of the axial slot 54 is desirably constant in the upper section
`48, but increases at a relief region 56 in the transition region
`52.
`In a preferred embodiment, the commissure posts 42 are
`formed of a biocompatible, elastic material, preferably
`metallic. For example, each commissure post 42 may be
`formed of stainless-steel, titanium, or Elgiloy. Alternatively,
`the commissure posts 42 may be a biocompatible polymer,
`such as Delrin or polyacetyl.
`In a preferred embodiment, the support stent 24 is formed
`from a single piece of ?at material. Speci?cally, the tubular
`base 40 initially comprises a ?at, narrow strip of uniform
`width material with the commissure posts 42 extending from
`one long side thereof. Using conventional means, the narrow
`strip of material is then rolled into the tubular shape shown
`in the ?gures, and the juxtaposed narrow ends joined by, for
`example, crimping. Each of the commissure posts 42 is then
`bent 180° outward to project in the opposite direction from
`their original direction. FIG. 1 illustrates such a con?gura
`tion in which a 180° bend 60 joins each commissure post 42
`to the in?ow rim 44. The radius of the bend 60 is such that
`a narrow space 62 is de?ned between the lower section 46
`of each commissure post 42 and the exterior of the tubular
`base 40.
`The ?exible tubular member 22 attaches to the support
`stent 24 as seen in FIG. 2,with the lea?et section 32
`connected to the commissure posts 42, and the fabric section
`34 connected to the tubular base 40. More speci?cally, the
`fabric section 34 surrounds the tubular base 40 and extends
`toward the in?ow rim 44 in the spaces 62 created inboard of
`each commissure post 42. Although not shown, the fabric
`section 34 may be attached to the exterior of the tubular base
`40, such as by sutures passed through the fabric and through
`openings in the tubular base. Because the axial dimension A
`of the fabric section 34 is greater than the axial dimension
`B of the tubular base 40, the seam 36 is disposed above the
`out?ow rim 50 (FIG. 1) of the base. This is more clearly
`shown in the cross-section of FIG. 3.
`The lea?et section 32 is disposed substantially between
`the commissure posts 42, except for a number of loops 70
`threaded outward through the axial slots 54. As seen FIGS.
`2—3, the loops 70 comprises regions of the tubular lea?et
`section 32 pinched and threaded through the axial slots 54.
`A plurality of inserts 72 are used to secure the loops 70 to
`the exterior of the commissure posts 42. That is, as seen FIG.
`4, the inserts 72 each have a width W that is greater than the
`circumferential width of the axial slots, 54. Because the
`inserts 72 are disposed within the loops 70, they prevent the
`loops from pulling inward again through the axial slot 54. A
`plurality of stitches 74 are preferably provided to secure the
`lea?et section 32 to the inserts 72. In addition, as seen in
`FIG. 3, stitching 76 passes through an aperture 78 in each
`insert 72, and through an aperture 80 provided in the out?ow
`end of each commissure post 42. In this manner, each insert
`72 is secured with respect to the support stent 24.
`With reference to FIGS. 2 and 5, a plurality of lea?ets 82,
`are de?ned between