U.S. patent application number 17/204779 was filed with the patent office on 2021-07-01 for expandable valve prosthesis with sealing mechanism.
The applicant listed for this patent is Mayo Foundation for Medical Education and Research, Sorin Group Italia S.r.l.. Invention is credited to Eric Manasse, Rakesh M. Suri, W. Andrew Ziarno.
Application Number | 20210196458 17/204779 |
Document ID | / |
Family ID | 1000005462590 |
Filed Date | 2021-07-01 |
United States Patent
Application |
20210196458 |
Kind Code |
A1 |
Suri; Rakesh M. ; et
al. |
July 1, 2021 |
EXPANDABLE VALVE PROSTHESIS WITH SEALING MECHANISM
Abstract
A prosthetic heart valve includes at least one sealing member.
The sealing member is adapted to conform to any surface
irregularities found on the inner surface of the valve annulus,
including any calcium deposits formed on the valve leaflets. The
sealing member can be self-expanding or non-expanding. When
deployed, the sealing member is adapted to create a blood tight
seal between the prosthetic heart valve and the inner surface of
the valve annulus thereby minimizing and/or eliminating
perivalvular leakage at the implantation site.
Inventors: |
Suri; Rakesh M.; (Rochester,
MN) ; Ziarno; W. Andrew; (Thalheim, DE) ;
Manasse; Eric; (Milano, IT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Sorin Group Italia S.r.l.
Mayo Foundation for Medical Education and Research |
Milano
Rochester |
MN |
IT
US |
|
|
Family ID: |
1000005462590 |
Appl. No.: |
17/204779 |
Filed: |
March 17, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15834837 |
Dec 7, 2017 |
10966823 |
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17204779 |
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11871447 |
Oct 12, 2007 |
9848981 |
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15834837 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2230/0054 20130101;
A61F 2220/005 20130101; A61F 2/2418 20130101; A61F 2250/0069
20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. A method of using a heart valve prosthesis at a native heart
valve site of a patient, the method comprising: delivering a heart
valve prosthesis in a radially collapsed configuration to an
implantation position at the native heart valve site, the heart
valve prosthesis comprising a plurality of prosthetic leaflets
coupled to an anchoring structure and at least one non-inflatable,
outer sealing skirt coupled to and extending circumferentially
about a portion of the anchoring structure such that the anchoring
structure does not pass through a side wall of the at least one
non-inflatable, outer sealing skirt; transitioning the heart valve
prosthesis from the radially collapsed configuration to an expanded
configuration at the implantation position such that the at least
one non-inflatable, outer sealing skirt conforms to an inner
surface of a native annulus at the native heart valve site to
reduce paravalvular leakage; and permitting blood flow through the
heart valve prosthesis upon opening of the plurality of prosthetic
leaflets.
2. The method of claim 1, wherein the anchoring structure has a
generally cylindrical shape.
3. The method of claim 1, wherein the anchoring structure comprises
an inflow portion adapted to engage and secure the anchoring
structure to the heart valve site and an outflow portion adapted to
be disposed adjacent to a Valsalva sinus of the patient.
4. The method of claim 3, wherein the at least one non-inflatable,
outer sealing skirt extends circumferentially about at least a
portion of that inflow portion that does not impede blood flow into
a coronary ostia of the patient.
5. The method of claim 1, wherein delivering the heart valve
prosthesis to the implantation position comprises delivering the
heart valve prosthesis to the implantation position at a native
aortic valve site.
6. The method of claim 1, further comprising, prior to delivering
the heart valve prosthesis, removing native leaflets of the native
heart valve.
7. The method of claim 1, further comprising, prior to delivering
the heart valve prosthesis, measuring a valve size based on the
native annulus and selecting the heart valve prosthesis based on
the valve size.
8. The method of claim 1, further comprising expanding a balloon
within the heart valve prosthesis in the expanded configuration at
the implantation position to apply radial force against an interior
of the heart valve prosthesis.
9. The method of claim 1, wherein the at least one non-inflatable,
outer sealing skirt comprises at least one of a viscoelastic
material or pericardial tissue.
10. The method of claim 1, wherein the at least one non-inflatable,
outer sealing skirt comprises at least one of silicone rubber or
latex rubber.
11. A method of using a heart valve prosthesis at a native heart
valve site of a patient, the method comprising: delivering a heart
valve prosthesis in a radially collapsed configuration to an
implantation position at the native heart valve site, the heart
valve prosthesis comprising an anchoring structure comprising an
outflow portion adapted to be disposed adjacent to a Valsalva sinus
of the patient and an inflow portion adapted to engage and secure
the anchoring structure to the native heart valve site, a plurality
of prosthetic leaflets coupled to the anchoring structure, and at
least one non-inflatable, outer sealing skirt coupled to and
extending circumferentially about at least a portion of that inflow
portion of the anchoring structure and adapted to permit blood flow
into a coronary ostia of the patient; transitioning the heart valve
prosthesis from the radially collapsed configuration to an expanded
configuration at the implantation position such that the at least
one non-inflatable, outer sealing skirt conforms to an inner
surface of a native annulus at the native heart valve site to
reduce paravalvular leakage; and permitting blood flow through the
heart valve prosthesis upon opening of the plurality of prosthetic
leaflets.
12. The method of claim 11, wherein the anchoring structure has a
generally cylindrical shape.
13. The method of claim 11, wherein the anchoring structure does
not pass through a side wall of the at least one non-inflatable,
outer sealing skirt.
14. The method of claim 11, wherein delivering the heart valve
prosthesis to the implantation position comprises delivering the
heart valve prosthesis to the implantation position at a native
aortic valve site.
15. The method of claim 11, further comprising, prior to delivering
the heart valve prosthesis, removing native leaflets of the native
heart valve.
16. The method of claim 11, further comprising, prior to delivering
the heart valve prosthesis, measuring a valve size based on the
native annulus and selecting the heart valve prosthesis based on
the valve size.
17. The method of claim 11, further comprising expanding a balloon
within the heart valve prosthesis in the expanded configuration at
the implantation position to apply radial force against an interior
of the heart valve prosthesis.
18. The method of claim 11, wherein the at least one
non-inflatable, outer sealing skirt comprises at least one of a
viscoelastic material or pericardial tissue.
19. The method of claim 11, wherein the at least one
non-inflatable, outer sealing skirt comprises at least one of
silicone rubber or latex rubber.
20. The method of claim 11, wherein the at least one
non-inflatable, outer sealing skirt decreases in volume when the
heart valve prosthesis transitions from the radially collapsed
configuration to the expanded configuration.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The application is a continuation of U.S. application Ser.
No. 15/834,837, filed Dec. 7, 2017, which is a continuation of U.S.
application Ser. No. 11/871,447, filed Oct. 12, 2007, now U.S. Pat.
No. 9,848,981, issued Dec. 26, 2017, both of which are herein
incorporated by reference in their entirety.
TECHNICAL FIELD
[0002] The present invention relates to instruments for the in situ
positioning of implantable devices. In particular, the invention
relates to a sealing mechanism for expandable prosthetic heart
valves to prevent perivalvular leakage.
BACKGROUND
[0003] Natural heart valves, such as aortic valves, mitral valves,
pulmonary valves, and tricuspid valves, often become damaged by
disease in such a manner that they fail to maintain bodily fluid
flow in a single direction. A malfunctioning heart valve may be
stenotic (i.e., calcification of the valve leaflets) or regurgitant
(i.e., heart leaflets are wide open). Maintenance of blood flow in
a single direction through the heart valve is important for proper
flow, pressure, and perfusion of blood through the body. Hence, a
heart valve that does not function properly may noticeably impair
the function of the heart. Left untreated, coronary valve disease
can lead to death.
[0004] Recently, there has been increasing consideration given to
the possibility of using, as an alternative to traditional
cardiac-valve prostheses, valves designed to be implanted using
minimally-invasive surgical techniques or endovascular delivery
(so-called "percutaneous valves"). Implantation of a percutaneous
valve (or implantation using thoracic-microsurgery techniques) is a
far less invasive act than the surgical operation required for
implanting traditional cardiac-valve prostheses. Upon implantation
of a heart valve prosthesis, it is important to ensure that a
blood-tight seal is created between the prosthesis and the valve
annulus in order to minimize or eliminate perivalvular leakage.
SUMMARY
[0005] According to one embodiment of the present invention, an
expandable valve prosthesis includes: at least one sealing member,
the sealing member adapted to provide a seal between the expandable
prosthesis and an inner surface of a valve annulus, the sealing
member adapted to conform to the inner surface of the annulus upon
deployment of the prosthesis.
[0006] According to another embodiment, the present invention is a
method of replacing a diseased native heart valve and includes
placing at least a portion of an expandable heart valve prosthesis
over a calcification on a native valve leaflet, and conforming the
portion to the contours of the calcification.
[0007] According to another embodiment, the present invention can
be a kit for replacement of a diseased heart valve. The kit
includes an expandable heart valve prosthesis, a seal sized and
dimensioned to restrict the flow of blood between the heart valve
prosthesis and an inner surface of the valve annulus, and a
delivery system for deployment of the expandable heart valve
prosthesis.
[0008] According to yet another embodiment of the present
invention, an expandable heart valve prosthesis can include one or
more portions configured to create a seal between the prosthesis
and at least two heart valve leaflets upon deployment of the heart
valve prosthesis.
[0009] According to another embodiment the present invention is a
method of replacing a diseased native heart valve. According to
this embodiment, the method includes creating a non-naturally
occurring aperture in a heart valve by excising one or more heart
valve leaflets or portions thereof, deploying an expandable heart
valve prosthesis, and sealing any remaining portion between at
least two heart valve leaflets and the valve annulus to prevent an
undesirable flow of blood past the prosthesis. At least a portion
of the prosthesis is located in the aperture.
[0010] According to another embodiment, the present invention is an
expandable heart valve prosthesis comprising one or more portions
thereof configured to create a seal between the prosthesis and at
least two heart valve leaflets when the prosthesis is deployed, the
seal being formed in a manner that does not require the seal to
increase in volume.
[0011] While multiple embodiments are disclosed, still other
embodiments of the present invention will become apparent to those
skilled in the art from the following detailed description, which
shows and describes illustrative embodiments of the invention.
Accordingly, the drawings and detailed description are to be
regarded as illustrative in nature and not restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a sectional view of a human heart showing the
pulmonary, aortic, and mitral valves.
[0013] FIGS. 2A-2C are perspective views of an expandable
prosthetic heart valve including one or more sealing members
according to various embodiments of the present invention.
[0014] FIG. 3 is a sectional view of a sealing member according to
an embodiment of the present invention.
[0015] FIGS. 4A and 4B are schematic views showing deployment and
delivery of an expandable prosthetic heart valve including a
sealing member according to an embodiment of the present
invention.
[0016] FIG. 5 is a schematic view showing an expandable prosthetic
valve at an implantation site according to an embodiment of the
present invention.
[0017] While the invention is amenable to various modifications and
alternative forms, specific embodiments have been shown by way of
example in the drawings and are described in detail below. The
intention, however, is not to limit the invention to the particular
embodiments described. On the contrary, the invention is intended
to cover all modifications, equivalents, and alternatives falling
within the scope of the invention as defined by the appended
claims.
DETAILED DESCRIPTION
[0018] FIG. 1 is a sectional view of a human heart 6 with an
expandable prosthetic heart valve 10 implanted within or adjacent
an aortic valve 16. The natural flow path of blood through the
heart 6 starts from superior and inferior vena cavas 20 to a right
atrium 24 and through a tricuspid valve 28 to facilitate blood flow
from the right atrium 24 to a right ventricle 32. A pulmonary valve
36 facilitates blood flow from the right ventricle 32 to the
pulmonary arteries 40. The blood is then oxygenated by the lungs
and returned back to the heart via pulmonary veins 44. A mitral
valve 48 then facilitates blood flow from a left atrium 52 to a
left ventricle 56. The aortic valve 16 facilitates blood flow from
the left ventricle 56 to an aorta 60 for perfusion of oxygenated
blood through the peripheral body, as shown by the implanted heart
valve 10. The sinuses of Valsalva 58 are also shown. As will be
appreciated by those skilled in the art, the sinuses of Valsalva 58
are, in a normal heart, three in number, and are distributed in an
approximately angularly uniform way around the root of the artery
distal to the semilunar valve (i.e., the aortic or pulmonary
valve).
[0019] The expandable prosthetic heart valve 10 is suitable for
placement within or adjacent a valved intraluminal site. The valved
intraluminal site includes the aortic valve 16, tricuspid valve 28,
the pulmonary valve 36, and the mitral valve 48 annuluses of the
heart 6. It will be appreciated however that the present invention
may be applied to valved intraluminal sites other than in the
heart. For example, the present invention may be applied to venous
valves as well. The intraluminal site typically includes surface
irregularities on the inner surface of the valve annulus. For
example, calcium deposits may be present on the valve leaflets
(e.g., stenotic valve leaflets). Another example includes a valve
leaflet that was not fully excised leaving behind a stump. These
surface irregularities, whatever their underlying cause, can make
it difficult for conventional prosthetic valves to form a blood
tight seal between the prosthetic valve and the inner surface of
the valve annulus, causing undesirable leakage at the implantation
site.
[0020] Typically the valve annulus includes two or more valve
leaflets. Occasionally, it may be desirable or necessary to use a
valve excisor or similar tool to create an artificial aperture in
the valve annulus by removing all or a portion of one or more valve
leaflets. Thus, the term "valve annulus" includes the inner surface
of the valve (natural or artificial) and, if appropriate, includes
the valve leaflets and any deposits formed on the valve annulus
including the leaflets.
[0021] According to one embodiment of the present invention, the
expandable valve prosthesis 10 is self-expanding, and can be either
a stented or stentless valve, as are known to those of skill in the
art. Upon expansion, the self-expanding valve prosthesis 10 is
radially constrained by the inner geometry of the intraluminal
site. The expandable prosthesis 10 places sufficient radial
expansion force on the inner surface of the valve annulus so as to
secure and stabilize the prosthesis at the intraluminal site. The
self-expanding valve prosthesis may be delivered to the
intraluminal site by placing valve prosthesis 10 within a delivery
catheter or sheath and removing the sheath at the valved
intraluminal site. According to an alternative embodiment of the
present invention, the prosthetic heart valve 10 can be balloon
expandable.
[0022] FIGS. 2A-2C are perspective views of an expandable
prosthetic heart valve 10 according to various exemplary
embodiments of the present invention. FIG. 3 is a top
cross-sectional view of an expandable prosthetic heart valve 10
implanted within the aortic valve 16. Exemplary expandable
prosthetic heart valves are shown and described in U.S. Publication
2006/0178740 and U.S. Publication 2005/0197695, both of which are
incorporated herein by reference.
[0023] As shown in FIGS. 2A and 2B, the expandable prosthetic
valves 10 typically include an armature 64, which is able to
support and fix the valve prosthesis 10 in the implantation
position. According to one embodiment, as shown in FIG. 2A, the
armature 64 includes an annular structure 66 and anchoring members
68a and 68b. The annular structure 66 of the armature 64 is
designed to be located upstream of the sinuses of Valsalva and
prosthetic valve. The anchoring members 68a and 68b are generally
arched, projecting towards the outside of the prosthesis 10. When
expanded at an intraluminal site, the anchoring members 68a and 68b
expand so as to ensure firm anchorage in the sinuses of Valsalva.
Alternatively, the prosthetic valve includes a stent-like armature
64, as shown in FIG. 2B. According to yet another embodiment of the
present invention, the prosthetic valve 10 can be a stentless,
self-expanding valve, as shown in FIG. 2C.
[0024] The prosthetic valve 10 also includes elements 69a, 69b, and
69c, generally in the form of leaflets or flaps, which are stably
connected to the anchoring structure and are able to regulate blood
flow.
[0025] As shown in FIGS. 2A-2C, the prosthetic heart valve 10
includes at least one sealing member 70. The sealing member(s) 70
is attached by an adhesive or other attachment means to the
exterior of the anchoring structure 64, as shown in FIGS. 2A and
2B. Alternatively, the sealing means may be attached to the base of
the prosthetic valve 10, as shown in FIG. 2C. The sealing member(s)
70 is configured to conform to the internal geometry of the inner
surface of the valve annulus in which the prosthetic valve 10 is
implanted. More particularly, the sealing member(s) 70 is
configured to conform to any surface irregularities present on the
inner surface of the valve annulus or the valve leaflets. According
to one embodiment of the present invention, shown in FIG. 2C, the
prosthetic heart valve 10 includes two sealing members 70. When the
prosthetic heart valve 10 is deployed at a target intraluminal
site, the sealing member can be located at the valve annulus,
slightly above the valve annulus, or slightly below the valve
annulus (or some combination thereof). When two or more sealing
members 70 are provided, the sealing members 70 can be located in
the same or different locations.
[0026] As best shown in FIG. 3, the sealing member(s) 70 provides a
seal between the expandable prosthesis 10 and the inner surface of
a valve annulus 71. More particularly, the sealing member(s) 70
provides a seal between the expandable prosthesis 10 and one or
move of the native valve leaflets or a calcium deposit 72. The seal
minimizes and/or eliminates any perivalvular (also commonly
referred to as "paravalvular") leakage at the implantation site. In
other words, the sealing member is sizes and dimensioned to
minimize and/or eliminates the flow of blood between the prosthesis
10 and the inner surface of the valve annulus 71. The appropriate
size and dimensions of the sealing member 70 can be readily
determined by one of skill in the art, depending on the desired
implantation site and its particular dimensions. As is generally
known in the art, the size and dimensions of a native valve annulus
will vary widely from one patient to another, thus the size and
dimensions of the sealing member 70 may vary accordingly. According
to yet another embodiment, the sealing member 70 is sized and
dimensioned in a custom manner, such that the sealing member 70 is
configured or optimized to fit the native valve annulus 71 anatomy
of a particular patient.
[0027] According to one embodiment of the present invention, the
sealing member(s) 70 is self-expanding. Upon implantation of the
prosthetic valve 10 in a valve annulus the sealing member 70
automatically expands such that it engages and conforms to the
inner surface of the valve annulus including any surface
irregularities that may be present. The sealing member 70 is made
from an elastic, deformable material that is sufficiently resilient
to withstand the forces of the beating heart and deformable enough
to conform over any calcium deposits or other surface
irregularities in or near the valve annulus. Exemplary materials
include foams, gels, biocompatible polymers, and the like.
[0028] According to a further exemplary embodiment of the present
invention, the sealing member 70 is made from a viscoelastic
material. Viscous materials resist shear flow and strain linearly
with time when a stress is applied. Elastic materials strain
instantaneously when stretched and return to their original state
once the stress is removed. Viscoelastic materials have elements of
both viscous and elastic properties and, as such, exhibit
time-dependent strain. Exemplary viscoelastic materials include,
but are not limited to, silicone and latex rubbers and bioglue.
[0029] According to one such embodiment, the sealing member 70 may
be sufficiently compressed to allow for minimally invasive delivery
of the prosthetic valve 10 through a catheter or cannula. Upon
deployment at the target site (e.g., the aortic valve annulus), the
sealing member elastically returns to its original configuration,
except as otherwise constrained by the native valve annulus,
leaflets, calcium deposits, and the like. In this embodiment, the
sealing member 70 does not expand in volume from its original
state, but instead only attempts to return to its original
configuration upon deployment at the target site. According to a
further aspect of this embodiment, the sealing member 70 may also
experience a decrease in volume, as the prosthetic valve 10 expands
from a compressed delivery configuration to an expanded
implantation configuration. In other words, the expansion of the
prosthetic valve may compress the sealing member 70 between the
armature 64 and the valve annulus 71.
[0030] According to an embodiment of the present invention, the
sealing member(s) 70 is configured to be inflated with an inflation
medium. According to this embodiment, as shown in FIG. 2C, the
sealing member(s) 70 includes an inflation manifold 74 for delivery
of the inflation medium into the sealing member 70. Once the
sealing member(s) 70 has been sufficiently inflated such that a
satisfactory seal has been created between the prosthetic valve 10
and the inner surface of the valve annulus, the inflation manifold
74 can be sealed off to maintain constant pressure within the
sealing member 70. The inflation medium can include a variety of
materials. Exemplary materials include, gels, biocompatible
polymers including curable polymers, gases, saline, and the
like.
[0031] According to yet another embodiment of the present
invention, the sealing member(s) 70 includes one or more internal
chambers 78. The chambers 78 are adapted to be inflated with an
inflation medium such as described above. According to a further
embodiment, the chambers 78 are configured to be selectively
inflated as desired or necessary. Imaging techniques known to those
of skill in the art can be used to locate the prosthetic valve in
the valve annulus and to determine whether or not a sufficient seal
exists between the prosthetic valve and the valve annulus. If
leakage is present, the sealing member (s) 70 or chamber 78 at or
near the site of the leakage can be selectively inflated until a
seal has been created.
[0032] According to yet another embodiment of the present
invention, the sealing member(s) 70 includes an intracellular
matrix, (e.g. memory foam) within its interior. The intracellular
matrix gives the sealing member 70 the ability to deform about the
surface irregularities found on the inner surface of the valve
annulus.
[0033] According to a further embodiment of the present invention,
the sealing member(s) 70 includes an extracellular matrix on its
exterior surface. The extracellular matrix promotes tissue ingrowth
at the site of implantation. An exemplary extracellular matrix
includes collagen. Stem cells can be added to the collagen matrix
to further promote and direct tissue ingrowth at the site of
implantation. Stem cells can differentiate into a wide variety of
cell types and their presence may lend to more specialized
applications and/or procedures at the site of implantation.
[0034] In yet another embodiment, the present invention is a kit
for implanting an expandable prosthetic heart valve at a valved
intraluminal site. The kit includes an expandable prosthetic heart
valve and a delivery tool such as a catheter or a sheath.
Additionally, the kit can include a leaflet excision tool for
removal or excision of the valve leaflets prior to deployment of
the prosthetic valve. The leaflet excision tool also includes a
device for capturing the excised leaflet for external removal of
the valve leaflet.
[0035] FIGS. 4A and 4B show schematic views of an expandable
prosthetic heart valve 10 including at least one sealing member
according to an embodiment of the present invention, being
delivered and deployed within the aortic valve 16. As shown in FIG.
4A, an expandable prosthetic valve 10 according to various
embodiments of the present invention can be collapsed and inserted
within a delivery catheter or sheath 84. The prosthesis is then
endovascularly delivered to the targeted valved intraluminal site,
for example the annulus of the aortic valve 16. The delivery of the
prosthetic valve 10 can be accompanied by a variety of
visualization techniques known to those of skill in the art. If
necessary, a leaflet excision tool is used to remove all or a
portion of one or more leaflets within the valve needing repair
and/or replacement. In this embodiment, a leaflet capture device 88
is provided along with the leaflet excision tool to capture the
excised leaflet portion such that it can be removed from the
patient's body. Once a suitable position has been determined for
valve placement, the delivery catheter sheath 84 is removed
allowing the prosthetic valve 10 to expand, as shown in FIG. 4B. At
least a portion of the expandable prosthetic valve is placed over a
calcium deposit on the inner surface of the valve annulus.
[0036] According to one exemplary embodiment of the present
invention as shown in FIG. 4B, the expandable prosthetic valve 10
includes at least one sealing member 70. According to one
embodiment of the present invention, the sealing member is
self-expanding. According to another embodiment, the sealing member
is inflatable. In either embodiment, the sealing member conforms to
the inner surface geometry of the valve annulus including any
surface irregularities, such as calcium deposits, that are present.
As shown in FIG. 4B, the sealing member 70 is positioned on the
prosthesis such that it creates and maintains a seal slightly above
the annulus of the aortic valve 16. As further shown in FIG. 4B, an
inflow portion of the prosthetic valve 10 is formed of a material
capable of exerting a sufficient radial force to maintain a steady
state, expanded orifice in relation to calcified native valve
leaflets, after ballooning of the native valve leaflets.
[0037] FIG. 5 illustrates another embodiment of the invention
featuring a prosthetic valve 10 having a sealing skirt 100, which
is located above the annulus and above a lower skirt 110. The lower
skirt 110 is sutured to the prosthesis, while the sealing skirt 100
is only sutured at a hinge 120 so that a flap 130 is free to be
pushed down by blood back flow coming from above the annulus with
is seen during diastole during 2/3 of the cardiac cycle. The lower
skirt 110 provides sealing at the annulus. The sealing skirt 100
provides a minimized perivalvular leakage at the annular and
infrannular region. The hinge 120 is located at the junction of the
inflow ring of the prosthesis and the sinus of Valsalva in one
embodiment of the invention. The sealing skirt 100 is free to
conform to anatomical structure of the native annulus, and it is
appreciated that over time fibrosis creates a permanent seal. The
sealing skirt 100 is free floating at insertion. When the
prosthesis is delivered antegrade from the apex of the heart, it is
possible to position the prosthesis further up from its final
desired location, partially deploy it so that the sealing skirt 100
does not form a tunnel structures but rather lies flat in the
aortic aspect of the annulus. If the prosthesis is delivered
through the aorta, the sealing skirt may naturally be juxtaposed
upon insertion into its desired location. The sealing skirt 100 is
dimensioned or of an appropriate height so as not to impede blood
flow into the coronary ostia.
[0038] Various modifications and additions can be made to the
exemplary embodiments discussed without departing from the scope of
the present invention. For example, while the embodiments described
above refer to particular features, the scope of this invention
also includes embodiments having different combinations of features
and embodiments that do not include all of the described features.
Accordingly, the scope of the present invention is intended to
embrace all such alternatives, modifications, and variations as
fall within the scope of the claims, together with all equivalents
thereof.
* * * * *