(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2002/0032481 A1
`Gabbay
`(43) Pub. Date:
`Mar. 14, 2002
`
`US 20020032481A1
`
`(54) HEART VALVE PROSTHESIS AND
`SUTURELESS MPLANTATION OF A HEART
`WALVE PROSTHESIS
`(76) Inventor: Shlomo Gabbay, Short Hills, NJ (US)
`Correspondence Address:
`Gary J. Pitzer
`Amin & Turocy, LLP
`SES...th Floor
`Cleveland, OH 4i 4 (US)
`9
`(21) Appl. No.:
`
`09/973,609
`
`(22) Filed:
`
`Oct. 9, 2001
`Related U.S. Application Data
`
`(63) Continuation-in-part of application No. 09/659.882,
`filed on Sep. 12, 2000.
`
`Publication Classification
`
`(51) Int. Cl." ........................................................ A61F 2/24
`(52) U.S. Cl. ...................... 623/2.11; 623/2.18; 623/1.14;
`62.3/2.14
`
`(57)
`
`ABSTRACT
`
`A heart Valve prosthesis and method of implanting the
`prosthesis are disclosed. A valve is mounted within a Support
`apparatus that is deformable between a first condition and a
`Second condition. The prosthesis has a cross-sectional
`dimension in the Second condition that is less than a croSS
`Sectional dimension of the Supported valve when in first
`condition. The prosthesis can be implanted into a patient's
`heart, Such as during a direct vision procedure through a
`tubular implantation apparatus that maintains the prosthesis
`in its Second condition until discharged from the tubular
`apparatuS.
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 1 of 24
`
`

`

`Patent Application Publication Mar. 14, 2002
`
`Sheet 1 of 10
`
`US 2002/0032481 A1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 2 of 24
`
`

`

`Patent Application Publication Mar. 14, 2002. Sheet 2 of 10
`
`US 2002/0032481 A1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 3 of 24
`
`

`

`Patent Application Publication Mar. 14, 2002. Sheet 3 of 10
`
`US 2002/0032481 A1
`
`
`
`
`
`
`
`
`
`Fig.6B
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 4 of 24
`
`

`

`Patent Application Publication Mar. 14, 2002 Sheet 4 of 10
`
`US 2002/0032481 A1
`
`
`
`AnN NE
`Fig.9B
`
`as-a-la--, ----.
`
`as
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 5 of 24
`
`

`

`Patent Application Publication Mar. 14, 2002. Sheet 5 of 10
`
`US 2002/0032481 A1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 6 of 24
`
`

`

`Patent Application Publication Mar. 14, 2002. Sheet 6 of 10
`
`US 2002/0032481 A1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 7 of 24
`
`

`

`Patent Application Publication Mar. 14, 2002. Sheet 7 of 10
`
`US 2002/0032481 A1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 8 of 24
`
`

`

`Patent Application Publication Mar. 14, 2002 Sheet 8 of 10
`
`US 2002/0032481 A1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 9 of 24
`
`

`

`Patent Application Publication Mar. 14, 2002. Sheet 9 of 10
`
`US 2002/0032481 A1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`|
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 10 of 24
`
`

`

`Patent Application Publication Mar. 14, 2002. Sheet 10 of 10 US 2002/0032481 A1
`
`
`
`734
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 11 of 24
`
`

`

`US 2002/0032481 A1
`
`Mar. 14, 2002
`
`HEART VALVE PROSTHESIS AND SUTURELESS
`IMPLANTATION OF A HEART WALVE
`PROSTHESIS
`
`REFERENCE TO RELATED APPLICATION
`0001. This application is a continuation-in-part of U.S.
`patent application Ser. No. 09/659.882, which was filed on
`Sep. 12, 2000 and entitled VALVULAR PROSTHESIS
`AND METHOD OF USING SAME, which is incorporated
`herein by reference.
`
`TECHNICAL FIELD
`0002 The present invention relates to an implantable
`prosthetic device and, more particularly, to a heart Valve
`prosthesis and to a method of implanting the prosthesis.
`
`BACKGROUND
`0003. It is well known to utilize mechanical heart valves,
`Such as the ball check Valve, and natural tissue cardiac
`Valves to replace defective aortic and mitral valves in human
`patients. One type of natural tissue heart Valve typically
`employs a porcine valve for implantation in a human, as they
`are very Similar to human valves of appropriate size and
`generally are easy to procure. Typically, the porcine valve is
`fixed by chemically treating it, Such as with an appropriate
`glutaraldehyde Solution. The treated porcine valve further
`may be mounted into a stent to Support the valve at a fixed
`position.
`0004 Astent typically is formed of a resilient material,
`Such as a plastic (e.g., DELRIN). Examples of various stent
`structures are disclosed in U.S. Pat. No. 3,983,581, U.S. Pat.
`No. 4,035,849. The stent usually is covered with a fabric
`material, Such as DACRON or a Suitable textile material.
`The fabric material provides Structure for Securing the valve
`relative to the stent. The stented heart valve prosthesis may
`be implanted into a patient for a heart Valve replacement.
`0005. In order to surgically implant a heart valve into a
`patient, the patient typically is placed on cardiopulmonary
`bypass during a complicated, but common, open chest
`procedure. In certain situations, an individual requiring a
`heart Valve replacement may be Sufficiently ill, Such that
`placing the individual on cardiopulmonary bypass may pose
`too great of risk. Such individuals may correspond to a class
`of patients who may have a non-functioning pulmonary
`Valve or Severe aortic valve insufficiency. In particular, many
`older patients having a deficient aortic or pulmonic valve
`may be too ill to Survive conventional open-heart Surgery.
`0006 Patients exhibiting these and other conditions
`would benefit from an improved heart valve prosthesis that
`may be implanted by a leSS invasive and/or more efficient
`implantation procedure.
`
`SUMMARY
`0007. The following presents a simplified summary of the
`invention in order to provide a basic understanding of Some
`aspects of the invention. This Summary is not an extensive
`overview of the invention. It is intended to neither identify
`key or critical elements of the invention nor delineate the
`Scope of the invention. Its Sole purpose is to present Some
`concepts of the invention in a simplified form as a prelude
`to the more detailed description that is presented later.
`
`0008 One aspect of the present invention provides a
`heart Valve prosthesis. The prosthesis includes a generally
`cylindrical Support having a plurality of Support features that
`extend generally axially between opposed ends of the Sup
`port. For example, the Support features can be formed of
`elongated, thin resilient wire or rods. Adjacent Support
`features further can be connected together by biasing ele
`ments (e.g., Springs) that urge interconnected Support fea
`tures apart from each other So as to bias the Support radially
`outwardly. The biasing elements can be arranged in a
`circular array at each of the opposed ends of the Support,
`Such as to provide a cage-like cylindrical Support. A valve,
`Such as a treated natural tissue valve, is mounted within the
`Support to define a Supported valve. The Supported valve can
`be deformed between reduced and expanded cross-sectional
`conditions to facilitate implantation of the prosthesis, while
`also providing desired functionality and coaptation of the
`valve when it is implanted.
`0009. Another aspect of the present invention provides a
`method for implanting a heart Valve prosthesis. The heart
`Valve prosthesis can be of the type described in the preced
`ing paragraph, although other types of Valves also could be
`implanted according to Such method. The heart Valve pros
`thesis is inserted into a generally cylindrical and elongated
`enclosure, Such that the prosthesis has a reduced croSS
`Sectional dimension generally corresponding to an internal
`dimension of the cylindrical enclosure. An opening is
`formed in a blood vessel and the portion of the enclosure
`holding the prosthesis is inserted through the opening. The
`cylindrical enclosure is positioned at a desired position and
`the prosthesis is discharged from the enclosure. As a result,
`the discharged heart Valve prosthesis expands from the
`reduced cross-sectional dimension to an expanded croSS
`Sectional dimension, Such that an exterior portion of the
`heart Valve prosthesis engages adjacent tissue to mitigate
`axial movement of the prosthesis relative to the adjacent
`tissue. The method can be performed without cardiopulmo
`nary bypass as well as without opening the patient's heart.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0010. To the accomplishment of the foregoing and related
`ends, certain illustrative aspects of the invention are
`described herein in connection with the following descrip
`tion and the annexed drawings. These aspects are indicative,
`however, of but a few of the various ways in which the
`principles of the invention may be employed and the present
`invention is intended to include all Such aspects and their
`equivalents. Other advantages and novel features of the
`invention will become apparent from the following detailed
`description of the invention when considered in conjunction
`with the drawings, in which:
`0011 FIG. 1 is an exploded isometric view of a valve and
`Stent apparatus that may be utilized to form a prosthesis in
`accordance with the present invention.
`0012 FIG. 1A is an enlarged view of part of the stent of
`FIG. 1 in a first condition.
`0013 FIG. 1B is an enlarged view of part of the stent of
`FIG. 1, similar to FIG. 1A, illustrating the part of the stent
`in a Second condition.
`0014 FIG. 2 is an example of a valvular prosthesis in
`accordance with the present invention.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 12 of 24
`
`

`

`US 2002/0032481 A1
`
`Mar. 14, 2002
`
`FIG. 3 is another example of valvular prostheses in
`0.015
`accordance with the present invention.
`0016 FIG. 4 is an example of the valvular prostheses of
`FIG. 3 implanted within a tubular member in accordance
`with the present invention.
`0017 FIG. 5 is another example of a stent apparatus in
`accordance with the present invention.
`0018 FIG. 6A is an example of the stent of FIG. 5
`mounted within an enclosure in accordance with the present
`invention.
`0019 FIG. 6B is an example of valvular prostheses
`having the stent of FIG. 5 mounted therein in accordance
`with the present invention.
`0020 FIG. 7 is an example of a valvular prosthesis,
`illustrating an outer sheath over the prosthesis of FIG. 6B in
`accordance with the present invention.
`0021
`FIG. 8 is another example of a valvular prosthesis,
`illustrating an outer sheath over the prosthesis of FIG. 6B in
`accordance with the present invention.
`0022 FIG. 9A is an example of enclosure that may be
`utilized for implanting a valvular prosthesis in accordance
`with the present invention.
`0023 FIG. 9B is an example of another enclosure cath
`eter mechanism that may be utilized for implanting a val
`Vular prosthesis in accordance with the present invention.
`0024 FIG. 10 is an example of a valvular prostheses
`implanted in an aortic position of a heart in accordance with
`the present invention.
`0.025
`FIG. 11 is an example of a valvular prostheses
`implanted in a pulmonic position of a heart in accordance
`with the present invention.
`0.026
`FIG. 12 is an example of a support structure in
`accordance with an aspect of the present invention.
`0.027
`FIG. 13 is an example of another support structure
`in accordance with an aspect of the present invention.
`0028 FIG. 14 is an example of a heart valve prosthesis
`employing the Support Structure in accordance with an
`aspect of the present invention.
`0029 FIG. 15 is a cross-sectional view of a heart valve
`prosthesis taken along line 15-15 in FIG. 14.
`0030 FIG. 16 is an example of another type of support
`Structure in accordance with an aspect of the present inven
`tion.
`FIG. 17 is another example of a heart valve pros
`0.031
`thesis employing the Support structure of FIG. 16 in accor
`dance with an aspect of the present invention.
`0.032
`FIG. 18 is an example of a heart valve prosthesis
`employing a Support Structure in accordance with an aspect
`of the present invention.
`0.033
`FIG. 19 is an example of an implanter apparatus
`for implanting a prosthesis in accordance with an aspect of
`the present invention.
`0034 FIG.20 is an enlarged view of part of the implanter
`apparatus of FIG. 19.
`
`0035 FIG. 21 is an example of a prosthesis being
`implanted at a desired location in accordance with an aspect
`of the present invention.
`0036 FIG. 22 is an example of a prosthesis mounted at
`a pulmonary position of a patient's heart in accordance with
`an aspect of the present invention.
`
`DESCRIPTION OF THE INVENTION
`0037 FIG. 1 is an exploded view of a valvular prosthesis
`10 in accordance with an aspect of the present invention. The
`prosthesis 10 includes a valve portion 12 and a Stent portion
`14 that may be assembled to form the valvular prosthesis 10,
`Such as shown in FIG. 2.
`0038. The valve portion 12 includes inflow and outflow
`ends 16 and 18 spaced apart from each other by a length of
`a generally cylindrical sidewall portion 20. While the inflow
`and outflow ends 16 and 18 are illustrated as being annular
`in FIGS. 1 and 2, those skilled in the art will understand and
`appreciate that other configurations (e.g., generally sinusoi
`dal ends) also could be used in accordance with the present
`invention.
`0039 The valve portion 12 also includes one or more
`leaflets 22, 24, and 26 that are attached to and extend from
`an interior of the sidewall portion 20. In the example
`illustrated in FIG. 1 and 2, the valve portion 12 includes
`three leaflets 22, 24 and 26, although other numbers of
`leaflets, Such as a single leaflet or two leaflets, also could be
`used.
`0040. The valve portion 12 may be formed of any sub
`Stantially biocompatible valve apparatus. By way of
`example, the valve portion 12 may include an animal heart
`valve (e.g., pulmonic or aortic), a manufactured valve device
`(e.g., a valve as shown and described in U.S. Pat. No.
`4,759,758 or U.S. Pat. No. 5,935,163) a venous valve (e.g.,
`a bovine or equine jugular venous valve). Those skilled in
`the art will understand and appreciate that the foregoing list
`is not intended to be exhaustive but, instead, is intended
`illustrate a few examples of the types of valves that may be
`utilized in a valvular prosthesis 10 in accordance with an
`aspect of the present invention.
`0041) If the valve portion 12 is formed of a natural tissue
`material, Such as an animal heart Valve, a venous valve, or
`a composite valve manufactured of natural tissue, the valve
`should be chemically fixed, Such as in a Suitable Solution of
`glutaraldehyde in a closed condition (as is known in the art).
`The fixation process facilitates closure of the valve 12 under
`application of back flow pressure, while remaining open
`during normal forward blood flow through the valve 12. By
`way of example, the natural tissue valve may be croSS-linked
`with glutaraldehyde and undergo a detoxification proceSS
`with heparin bonding, such as according to a NO-REACTOR
`treatment process from Shelhigh, Inc. of Millburn, N.J. The
`NO-REACT(F) treatment improves biocompatibility of the
`Valve apparatus 12 and mitigates calcification and thrombus
`formation.
`0042. In accordance with an aspect of the present inven
`tion, the valve portion 12 exhibits structural memory. That
`is, if the valve apparatus 12 is compressed, Such as to a
`reduced diameter at the time of being implanted, it will
`return Substantially to its original shape and configuration
`upon removal of radially inward forces. As a result, the valve
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 13 of 24
`
`

`

`US 2002/0032481 A1
`
`Mar. 14, 2002
`
`apparatus 12 is able to maintain coaptation of the leaflets 22,
`24, and 26 even after being deformed. The memory feature
`of the valve is further improved by mounting it within the
`stent portion 14.
`0.043 Turning now to the stent portion 14, such as shown
`in FIGS. 1 and 2, the stent includes an inflow end 30 and
`an outflow end 32. In this example, the inflow and outflow
`ends 30 and 32 are spaced apart from each other a distance
`that is greater than the distance between the corresponding
`ends 18 and 16 of the valve 12. In this way, the ends of the
`stent 30 and 32 may extend beyond the respective ends 18
`and 16 of the valve 12 (e.g., by about a few millimeters),
`such as shown in FIG. 2. The stent portion 14 also may
`include outwardly turned portions at the inflow and outflow
`ends 30 and 32 of the stent, which, when implanted, may
`engage and/or be urged into the Surrounding tissue to
`mitigate movement thereof.
`0044 According to an aspect of the present invention, the
`stent 14 may deformable between first and second condi
`tions, in which the first condition has a reduced croSS
`Sectional dimension relative to the second condition. FIGS.
`1 and 2 illustrate the stent portion 14 as being formed of a
`mesh or weave 34 extending between the ends 30 and 32.
`The mesh 34 may be a metal, an alloy, or other suitable
`material that may help Support a valve mounted therein
`and/or help anchor the valve at a desired position when
`implanted.
`0.045 By way of example, the mesh may be formed of a
`shape memory alloy material, Such as may be formed of a
`nitinol (nickel-titanium alloy) wire. Shape memory (or ther
`mal memory) is a characteristic in which a deformed part
`remembers and recovers to a pre-deformed shape upon
`heating. By forming the Stent 14 of a shape memory alloy,
`the Stent is inelastically deformable to new shape, Such as a
`reduced cross-sectional dimension, when in its low-tempera
`ture (martensitic) form. For example, the Stented valve
`(FIG. 2) may be cooled, such as by being introduced to a
`cooling Solution (e.g., water), and then compressed.
`0046) When the stent 14 is heated to its transformation
`temperature, which may vary according to the alloy com
`position, it quickly reverts to its high-temperature (austen
`itic) form. The Stented valve may retain the compressed
`condition by keeping it cooled. Alternatively, the Stent and
`Valve may be retained in the compressed position, Such as
`with Sutures circumscribing the Structure, a cylindrical
`enclosure around the structure, etc. The prosthesis 10 will
`then return toward its high-temperature (or original) position
`upon removal of the retaining element.
`0047. It is to be appreciated that, alternatively, the stent
`14, in accordance with an aspect of the present invention,
`could be inelastically deformable So as to require an inter
`vening force to return the deformed Stent Substantially to a
`desired configuration. For example, a balloon catheter or
`Spring mechanism could be employed to urge the Stent and
`the valve located therein generally radially outward So that,
`after being implanted to a desired position, the Stent will
`engage the Surrounding tissue in a manner to inhibit move
`ment relative to the Surrounding tissue.
`0048 FIGS. 1A and 1B illustrate an enlarged view of
`part of the Stent 14 in accordance with an aspect of the
`present invention. In this example, Some Strands of the mesh
`
`34 are broken to define spaces 36 between adjacent lateral
`extensions or spike portions 38 and 40. As the stent 14 is
`deformed, such as shown in FIG. 1 B, the spike portions 38
`and 40' may extend radially outwardly from the stent in
`different directions. In addition, the inflow end 32' also may
`flare outwardly for engagement with Surrounding tissue
`when implanted. For example, some spikes 40, 40' may
`extend generally outwardly and toward an outflow end of the
`stent 14, while others 38, 38' may extend generally out
`wardly and toward an inflow end 32,32". The spikes thus are
`operable to engage tissue, when implanted, So as to inhibit
`axial movement of the Stent 14 relative to the Surrounding
`tissue.
`0049 Referring back to FIG. 2, the valve portion 12 is
`disposed generally coaxially within the cylindrical Stent
`portion 14 relative to the central axis A. The valve 12 may
`be affixed relative to the stent portion 14, such as by one or
`more sutures 44. The sutures 44 may be located at the inflow
`and outflow ends 16 and 18 of the valve 12 to connect the
`valve to the stent 14 to inhibit axial movement of the valve
`relative to the Stent. Alternatively or additionally, axial
`movement between the stent 14 and valve 12 may be
`mitigated due to friction fitting between the Stent and valve
`portion. For example, as illustrated in FIG. 2, the valve
`portion 12 has a croSS-Sectional diameter that is slightly
`larger than that of the stent 14, such that the prosthesis 10
`bulges. Somewhat in the middle and is narrower near the
`inflow and outflows ends 16 and 18 of the valve portion 12.
`0050 AS mentioned above, the stent portion 14 may be
`formed of a shape memory alloy. In this way, the valvular
`prosthesis 10 may be compressed to a reduced croSS-Sec
`tional dimension about the axis A and maintained at the
`reduced dimension while being implanted. Once the valvu
`lar prosthesis 10 is at a desired implantation position, the
`prosthesis may be permitted to return toward its original
`croSS-Sectional dimension So as to engage a valve wall or
`other Surrounding tissue at the desired position. The engage
`ment between the stented valvular prosthesis 10 and the
`Surrounding tissue inhibits axial movement of the prosthesis
`relative to the tissue. In accordance with an aspect of the
`present invention, lateral extensions or Spikes (see, e.g.,
`FIGS. 1A and 1B) may extend outwardly from the stent to
`further inhibit axial movement. Those skilled in the art will
`understand and appreciate that a valvular prosthesis 10, in
`accordance with the present invention, may be utilized to
`replace a heart Valve or utilized as an intravascular implant
`to provide an operable venous valve.
`0051 FIG. 3 illustrates another example of a stented
`valvular prosthesis 50 in accordance with an aspect of the
`present invention. The prosthesis 50 in this example includes
`a valve portion 52 mounted within a stent portion 54. The
`Valve portion 52 in this example, has a generally sinusoidal
`outflow end 56 having a plurality of commissure posts 58,
`60, and 62 extending from an annular base portion 64, with
`corresponding Sinuses located between each adjacent pair of
`posts. It is to be appreciated that, alternatively, a valve
`having a Sidewall portion according to generally cylindrical
`configuration of FIGS. 1 and 2 also could be used in
`conjunction with the stent portion 54.
`0052 The stent portion 54 in this example is formed of a
`deformable mesh, which may be substantially identical to
`that described above with respect to FIGS. 1-2. The stent
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 14 of 24
`
`

`

`US 2002/0032481 A1
`
`Mar. 14, 2002
`
`portion 54 also includes a plurality of Spikes extending
`generally radially outwardly from the Stent portion. In
`particular, one set of spikes 66 extend from an inflow end 68
`of the stent portion 54 and another set of spikes 70 extend
`from an outflow end 72 of the stent.
`0053 FIG. 4 illustrates the prosthesis 50 of FIG. 3
`mounted in an expanded condition within a generally cylin
`drical sidewall 74. The sidewall 74, for example, may be a
`venous valve wall, a pulmonary artery, an aorta, etc. In this
`example, the Spikes 66 and 70 engage and/or extend into the
`valvular wall 74 to inhibit axial movement of the prosthesis
`50 relative to the valve wall 74.
`0.054
`FIG. 5 illustrates another example of a stent appa
`ratus 80 which may be utilized as part of a valvular pros
`thesis in accordance with an aspect of the present invention.
`The stent 80 includes a generally annular base portion 82
`and a plurality of axially extending portions (or Stent posts)
`84, 86 and 88 extending generally axially from the base
`portion. The post portions 84, 86 and 88 are circumferen
`tially Spaced apart for generally radial alignment with cor
`responding commissure posts of an associated valve wall.
`While the example of the stent 80 in FIG. 5 has three stent
`posts 84, 86 and 88, those skilled in the art will understand
`and appreciate that other numbers of posts also could be
`utilized in accordance with an aspect of the present inven
`tion. Typically, however, the number of posts and their
`relative circumferential position correspond to the number
`of leaflets of a valve to be mounted within the stent 80.
`0055. In accordance with an aspect of the present inven
`tion, each of the stent posts 84, 86, 88 may extend radially
`outwardly an angle T relative to the axis A. By way of
`example, the angle T may range from about 10 to about 60
`degrees relative to a line drawn through the juncture of each
`post and the base 82 parallel to the central axis A. The
`outwardly extending posts 84, 86, and 88 facilitate engage
`ment between each respective post and Surrounding tissue
`when implanted, as the posts (being resilient) tend to urge
`radially outwardly and into engagement with Such tissue.
`0056. The stent 80 also includes a plurality of spikes 90
`and 92 that extend radially outwardly from the stent. In
`particular, Some outwardly extending Spikes 90 are curved
`generally toward an outflow end of the stent and others 92
`are curved generally toward an inflow end of the Stent. In
`addition, a row of spikes 90 may extend outwardly relative
`to the stent 80 at the inflow end thereof, which spikes also
`are curved generally toward the outflow end. The varying
`contour of the spikes 90 and 92 mitigates axial movement of
`the stent 80 (in both axial directions) relative to tissue
`engaged thereby, Such as after being implanted. It is to be
`understood and appreciated that, while a single row of Spikes
`is illustrated near the inflow end of the stent in FIG. 5, two
`or more axially spaced apart rows of Spikes extending
`generally radially outwardly from the stent 80 could also be
`utilized in accordance with an aspect of the present inven
`tion. The rows of spikes may be curved toward each other to
`provide a clamping function on Surrounding tissue when
`implanted.
`0057 FIG. 6A illustrates the stent of FIG. 5 mounted
`within a tubular structure 94 that has an inner diameter that
`is Substantially commenSurate with the outer diameter of the
`base portion 82 of the stent 80. The tubular structure 94 may
`be formed of a plastic or other material effective to hold the
`
`stent posts 84, 86, and 88 at a radial inward position. In this
`way, the tubular structure 94 urges the stent posts 84, 86, and
`88 radially inward to a position that facilitates mounting a
`valve 98 therein. For example, the valve 98 may be posi
`tioned within and connected to the stent 80, such as by
`Sutures applied along the base portion 82 and the Stent posts
`84, 86, and 88; without having to manually hold each of the
`posts against corresponding parts of the valve.
`0.058 FIG. 6B illustrates an example in which a valve 98
`has been mounted within the Stent 80 of FIG. 5 to form a
`valvular prosthesis 100. The valve 98 includes an inflow end
`102 and an outflow end 104. The inflow end 102 of the valve
`98 is positioned adjacent relative to the inflow end of the
`Stent 80. The outflow end 104 of the valve 98 is contoured
`to include axially extending commissure posts 106, 108 and
`110 with sinuses 112, 114 and 116 located between each
`adjacent pair of posts. Valve leaflets 118, 120 and 122 extend
`between adjacent posts commensurate with the location of
`each of the sinuses 112, 114 and 116. The stent 80 may be
`connected to the valve 98 via Sutures 124.
`0059. In accordance with an aspect of the present inven
`tion, the prosthesis 100 of FIG. 6B is a stented valve, which
`may be covered with an outer sheath of a substantially
`biocompatible material.
`0060 FIG. 7 illustrates an example of a valvular pros
`thesis in which an outer sheath 130 has been applied over the
`stent 80 and at least part of the exposed exterior portion of
`the valve 98 in accordance with an aspect of the present
`invention. As illustrated, the outer sheath 130 may have
`inflow and outflow ends having generally the same contour
`as the Sidewall of the valve 98 and the Stent 80. The Outer
`sheath 130 may be a sheath of natural tissue pericardium
`(e.g., bovine, equine, porcine, etc.), another biological tissue
`material (e.g., collagen), or a Synthetic material (e.g.,
`Dacron). When a biological tissue is utilized, for example, it
`may be cross-linked with glutaraldehyde and detoxified with
`heparin bonding, such as one of the NOREACTOR natural
`tissue products that are commercially available from Shel
`high, Inc. of Millburn, N.J.
`0061 An implantation flange (or sewing ring) 132 may
`be formed at the inflow end of the prosthesis 100. The
`implantation flange 132 may be formed of substantially the
`same material as the outer sheath 140, Such as formed from
`the Outer sheath 130 or by attaching a separate flange by
`other methods. The outer sheath 130 may be attached to the
`valve 98 and/or to the stent 80 by applying sutures 134 and
`136 at the respective inflow and outflow ends of the pros
`thesis 100. Some of the spikes 90, 92 may extend through
`the outer sheath 130 so as to mitigate axial movement of the
`prosthesis 100 relative to Surrounding tissue when the pros
`thesis is implanted. Sutures 134 and 136 may be applied
`respectively at the inflow and outflow ends to Secure the
`outer sheath relative to the Stent 80 and the valve 100. The
`outer sheath 130 may include an outflow end that conforms
`to the contour of the outflow end 104 of the valve 100.
`0062 FIG. 8 illustrates another example of valvular
`prosthesis 100 that is similar to that shown and described in
`FIG. 7, in which identical reference numbers refer to
`corresponding parts previously identified herein. The pros
`thesis 100 includes having an outer sheath 140 that is
`disposed about the stent 80 and the valve 98 and having an
`outflow end that follows the contour of the prosthesis 100
`
`Edwards Lifesciences Corporation, et al. Exhibit 1009, p. 15 of 24
`
`

`

`US 2002/0032481 A1
`
`Mar. 14, 2002
`
`(e.g., generally sinusoidal. In addition, the Outer sheath 140
`includes a plurality of axially extending lobes 142,144 and
`146 extending axially beyond the outflow attachment of the
`valve leaflets 118, 120, and 122. In this example, the lobes
`142, 144 and 146 extend axially a length beyond the
`commissure posts 106,108 and 110 of the valve 98. The
`axially extending lobes 142,144 and 146 provide additional
`Structure that may be utilized to help Secure the prosthesis
`100 relative to surrounding tissue when being implanted.
`When the prosthesis 100 of FIG. 8 is implanted, for
`example, Sutures may be applied through the lobes 142,144
`and 146 to help Secure the commissure posts of the proS
`thesis relative to the Surrounding tissue. Additional Sutures
`also could be applied at the inflow end to the implantation
`flange 132 located thereat.
`0063 FIGS. 9A and 9B illustrate variations of an
`implantation apparatus 200 that may be utilized to implant
`a valvular prosthesis 202 in accordance with an aspect of the
`present invention. It is to be understood and appreciated that
`any of the prosthesis shown and/or described herein may be
`implanted with Such an implantation apparatus.
`0064. With reference to FIG.9A, by way of example, the
`implantation apparatus 200 may be in the form of a catheter
`System. The implantation apparatus includes an elongated
`connecting element 204 extending between a trigger mecha
`nism 206 and an enclosure 208, in which the prosthesis 202
`is located. At least a portion of the prosthesis 202 is located
`within the enclosure 208. A plunger mechanism 210 is
`located at a proximal end of the enclosure 208 for urging the
`prosthesis 202 generally axially from the enclosure 208. An
`opposite end 212 of the enclosure 208 may be formed of a
`pliable material or a plurality of moveable members that
`may open as the prosthesis 202 is urged through an opening
`214 located at a distal end. It is to be appreciated that the
`length of the connecting element 204 may vary according to
`where the valvular prosthesis 202 is to be implanted and the
`method of implantation.
`0065. The valvular prosthesis 202 is illustrated within the
`enclosure 208 in a compressed condition, Such as described
`above. That is, the valvular prosthesis 202 within the enclo
`Sure 208 has a cross-sectional dimension that is less than its
`normal cross-sectional dimension, being maintained in Such
`position by the enclosure. Those skilled in the art will
`appreciate that the orientation of the valvular prosthesis 202
`will var