U.S. patent application number 11/403077 was filed with the patent office on 2006-08-17 for self-molding annuloplasty ring.
Invention is credited to Salvador Marquez.
Application Number | 20060184241 11/403077 |
Document ID | / |
Family ID | 25472169 |
Filed Date | 2006-08-17 |
United States Patent
Application |
20060184241 |
Kind Code |
A1 |
Marquez; Salvador |
August 17, 2006 |
Self-molding annuloplasty ring
Abstract
A resilient self molding annuloplasty ring which may be enlarged
prior to implantation to facilitate implantation within a dilated
or otherwise incompetent valve annulus having sufficient
contractive force to render a valve competent. The self-molding
annuloplasty ring may further comprise integral attachment devices
to aid in the implantation process. The resilient self-molding
annuloplasty ring may be stretched to an expanded diameter and
attached to a heart valve annulus, then permitted to contract to
reduce the diameter of the annulus. The ring may be positioned on
an insertion device that maintains the ring in its expanded
diameter while attaching to the annulus.
Inventors: |
Marquez; Salvador; (Foothill
Ranch, CA) |
Correspondence
Address: |
EDWARDS LIFESCIENCES CORPORATION
LEGAL DEPARTMENT
ONE EDWARDS WAY
IRVINE
CA
92614
US
|
Family ID: |
25472169 |
Appl. No.: |
11/403077 |
Filed: |
April 12, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10777343 |
Feb 12, 2004 |
7063722 |
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11403077 |
Apr 12, 2006 |
|
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09938902 |
Aug 24, 2001 |
6726716 |
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10777343 |
Feb 12, 2004 |
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Current U.S.
Class: |
623/2.36 |
Current CPC
Class: |
A61F 2/2448 20130101;
A61F 2/2445 20130101; Y10S 623/902 20130101 |
Class at
Publication: |
623/002.36 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. A self-molding annuloplasty ring for implantation in a dilated
heart valve annulus having a dilated size, comprising: a resilient
inner sizing member positioned within an outer attachment sheath,
the annuloplasty ring defining a shape having a first diameter in
the absence of an external force, the resilient inner sizing member
having sufficient elasticity to permit pre-stretching such that the
annuloplasty ring attains an expanded diameter larger than the
first diameter and equivalent to the dilated size of the dilated
valve annulus, the resilient inner sizing member being biased
toward its relaxed diameter and having sufficient contractive force
to decrease the dilated size of the dilated valve annulus when the
expanded diameter annuloplasty ring is attached thereto.
2. The device of claim 1, further comprising support structure on
the annuloplasty ring that limits inward contraction of the inner
sizing member to a contracted diameter that is larger than its
relaxed diameter.
3. The device of claim 2, wherein the support structure includes a
series of support members positioned along the inner sizing member
which engage one another to limit inward contraction of the inner
sizing member.
4. The device of claim 3, wherein each support member comprises a
body member having a lumen formed therein, the lumen being sized to
receive the inner sizing member.
5. The device of claim 1, wherein the annuloplasty ring further
comprises a plurality of attachment devices positioned thereon and
extending outward from the outer attachment sheath.
6. The device of claim 5, wherein the plurality of attachment
devices is selected from the group consisting of: needles; barbs;
and hooks.
7. The device of claim 5, wherein the material of the plurality of
attachment devices is selected from the group consisting of:
stainless steel; titanium; and a nickel-titanium alloy.
8. The device of claim 1 wherein the inner sizing member comprises
a biologically compatible elastomer.
9. The device of claim 1, wherein the outer attachment sheath
comprises a medicament to induce tissue growth.
10. The device of claim 1, wherein the annuloplasty ring has a
closed shape selected from the group consisting of: a "D" shape; a
generally round shape; and an oval shape.
11. An annuloplasty device for implantation in a dilated heart
valve annulus, comprising: an insertion device; and an annuloplasty
ring having a resilient inner sizing member positioned within an
outer attachment sheath, the annuloplasty ring being expandable
from a first diameter to a larger expanded diameter, the
annuloplasty ring being positioned on the insertion device and
maintained at its expanded diameter; wherein, on the insertion
device the resilient inner sizing member is biased so as to urge
the annuloplasty ring toward its first diameter such that if the
insertion device is removed the annuloplasty ring contracts.
12. The device of claim 11, wherein the insertion device has a size
commensurate with the diameter of the dilated valve annulus.
13. The device of claim 11, further comprising support structure on
the annuloplasty ring that limits inward contraction of the inner
sizing member to a contracted diameter that is larger than its
relaxed diameter.
14. The device of claim 13, wherein the support structure includes
a series of support members positioned along the inner sizing
member which engage one another to limit inward contraction of the
inner sizing member.
15. The device of claim 11, wherein the annuloplasty ring further
comprises a plurality of attachment devices positioned thereon and
extending outward from the outer attachment sheath.
16. The device of claim 15, wherein the plurality of attachment
devices is selected from the group consisting of: needles; barbs;
and hooks.
17. The device of claim 15, wherein the material of the plurality
of attachment devices is selected from the group consisting of:
stainless steel; titanium; and a nickel-titanium alloy.
18. The device of claim 11 wherein the inner sizing member
comprises a biologically compatible elastomer.
19. The device of claim 11, wherein the outer attachment sheath
comprises a medicament to induce tissue growth.
20. The device of claim 11, wherein the annuloplasty ring has a
closed shape selected from the group consisting of: a "D" shape; a
generally round shape; and an oval shape.
Description
RELATED APPLICATIONS
[0001] The present application is a continuation of Ser. No.
10/777,343, filed Feb. 12, 2004, entitled METHOD OF IMPLANTING A
SELF-MOLDING ANNULOPLASTY RING, which is a continuation of Ser. No.
09/938,902, filed Aug. 24, 2001, entitled SELF-MOLDING ANNULOPLASTY
RING, now U.S. Pat. No. 6,726,716, which applications are expressly
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] The human heart is hollow muscular organ having four pumping
chambers separated by four heart valves. The mitral and tricuspid
valves, present at the left and right atrio-ventricular junctions,
open and close in response to a pressure gradient during each
cardiac cycle of relaxation and contraction to control the flow of
blood to a particular region of the heart.
[0003] These valves are comprised of a dense fibrous ring known as
the annulus, leaflets or cusps attached to the annulus, and a
complex of chordae tendineae and papillary muscles securing the
leaflets. The size of the leaflets or cusps is such that when the
heart contracts the resulting increased blood pressure formed
within the ventricular cavity forces the leaflets towards the
arterial cavity. As a result, the leaflets or cusps come in
apposition to each other thereby closing the atrio-ventricular
passage.
[0004] Natural defects and heart disease are common causes of
valvular dysfunction within the heart of a patient. One common
example of valvular dysfunction occurs when the annulus becomes
excessively dilated or the valve geometry results in ineffective
valve closure, which results in regurgitation. Due to the increased
diameter of the annulus, the leaflets or cusps fail to meet during
systolic contraction, thereby resulting in the regurgitation of
blood during ventricular contractions. As such, sufficient back
pressure exists within the chambers of the heart capable of forcing
some blood flow to traverse the atrio-ventricular junction from the
ventricle to the atria.
[0005] One manner of repairing this problem involves surgically
implanting a prosthetic ring (i.e. "annuloplasty ring") about the
dilated annulus, thereby restoring the annulus to the normal size
and shape and allowing the valve leaflets to function normally.
Commonly, a surgeon positions the annuloplasty ring near the valve
annulus and sutures the device in place.
[0006] One approach to correcting or remodeling the valve annulus
has required the implantation of a rigid annuloplasty ring.
Typically, an annuloplasty ring having the desired internal
diameter is positioned near the heart valve and sutured in place.
As a result, the diameter of the valve is reduced to the diameter
of the annuloplasty ring. This procedure utilizing current
annuloplasty rings has several shortcomings. For example, the
tissue comprising the heart, particularly in the area of the heart
valves, is flexible. The implantation of a rigid annuloplasty ring
restricts the natural flexibility of this tissue, and may impact
the heart's function. Also, the diameter of the dilated annulus is
substantially larger than the annuloplasty ring, thereby making the
implantation surgery unnecessarily time consuming. The surgeon is
required to position the prosthesis near a portion of the tissue
and suture the ring in place. Thereafter, the opposing tissue is
forced to engage the ring and is attached to the annuloplasty ring
with sutures. Consequently, the sutures may be under different
stress loads, and could result in an increased risk of ring
dehiscence.
[0007] There is thus a need for a flexible annuloplasty prosthesis
and implantation device that enables a surgeon to precisely
position and apply an annuloplasty ring to the dilated valve
annulus.
SUMMARY OF THE INVENTION
[0008] The present invention solves the aforementioned problems in
that the resilient annuloplasty ring of the present invention may
be stretched to the diameter of the dilated valve annulus prior to
implantation, thereby simplifying the implantation process. In
addition, the contractive force of the resilient annuloplasty ring
of the present invention may controllably reduce the diameter of an
incompetent dilated valve annulus to more competent diameter. Those
skilled in the art will appreciate the present invention is easy to
manufacture and may be manufactured from a plurality of
materials.
[0009] The annuloplasty ring of the present invention comprises a
resilient inner sizing member positioned within a flexible outer
attachment sheath. The resilient inner sizing member applies a
contractive force to the incompetent annulus tissue. The flexible
outer attachment sheath permits the surgeon to attach the device to
the annulus tissue in a plurality of manners including suturing and
stapling. The annuloplasty ring of the present invention may be
manufactured from a plurality of biologically compatible materials
having sufficient resiliency to permit stretching during
implantation and having sufficient contractive force to permit a
reduction in the diameter of the incompetent valve annulus.
[0010] An alternate embodiment of the present self molding
annuloplasty ring comprises an resilient inner sizing member
positioned within a flexible outer attachment sheath, the ring
further having a plurality of attachment members positioned
thereon. The attachment members may comprise a plurality of
devices, including, without limitation, needles, barbs, or hooks.
In addition, the attachment members may be manufactured from a
biologically compatible material such as, without limitation,
stainless steel, titanium, and Nitinol.
[0011] In yet another embodiment of the present invention, a self
molding annuloplasty ring having a predetermined contracted
diameter is disclosed. This embodiment comprises a resilient inner
sizing member positioned within a series of individual support
members. A flexible outer attachment sheath is positioned on the
exterior of the support members. This embodiment permits the
surgeon to predetermine the inner diameter of a repaired valve
annulus, thereby rendering an incompetent valve competent. Those
skilled in the art will appreciate that the support members may be
manufactured from a biologically compatible material such as,
without limitation, plastic and elastomer.
[0012] Other objects, features, and advantages of the present
invention will become apparent from a consideration of the
following description of the preferred embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The apparatus of the present invention will be explained in
more detail by way of the accompanying drawings, wherein:
[0014] FIG. 1 shows a top sectional view of the mitral and
tricuspid valves and valve annuli within a heart;
[0015] FIG. 2A shows a side view of the annuloplasty ring of the
present invention;
[0016] FIG. 2B shows a top view of the annuloplasty ring of the
present invention;
[0017] FIG. 2C shows a cross sectional view of the annuloplasty
ring of the present invention;
[0018] FIG. 2D shows an alternate embodiment of the annuloplasty
ring of the present invention having a support member positioned
therein;
[0019] FIG. 2E shows a perspective view of the annuloplasty ring of
the present invention;
[0020] FIG. 3A shows a top sectional view of the annuloplasty ring
of the present invention positioned within the valve annulus of the
mitral valve;
[0021] FIG. 3B shows a top view of an embodiment of the present
embodiment having a plurality of attachment devices disposed
thereon;
[0022] FIG. 3C shows a cross sectional view of the present
embodiment with an attachment device disposed thereon;
[0023] FIG. 3D shows a perspective view of the present embodiment
having a plurality of attachment devices disposed thereon;
[0024] FIG. 4A shows a top view of the present embodiment of the
present invention in a contracted state having a plurality of size
support members positioned thereon;
[0025] FIG. 4B shows a top view of the present embodiment of the
present invention in a stretched state having a plurality of size
support members positioned thereon; and
[0026] FIG. 4C shows a cross sectional view of the embodiment of
FIGS. 4A and 4B.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0027] The following detailed description and the accompanying
drawings are intended to describe and show certain presently
preferred embodiments of the present invention, and are not
intended to limit the scope of the invention in any way.
[0028] The self-molding annuloplasty ring of the present invention
is generally used in surgical procedures to repair an incompetent
tissue annulus. More specifically, the present invention is used to
render an otherwise incompetent heart valve competent by decreasing
the diameter of the opening at the valvular junction. As those
skilled in the art will appreciate, the present invention may be
manufactured with varying degrees of pre-tension and contractive
force, thereby permitting variations of the contraction of the
anterior and/or posterior annuli. In addition, the present
invention simplifies the implantation procedure by permitting
pre-stretching of the annuloplasty ring to the diameter of the
dilated annulus, and thereafter reducing the annulus with the
contractive force exerted by the self-molding annulus ring.
[0029] FIG. 1 shows a cross sectional view of the heart 10 having a
bicuspid or mitral valve 12 positioned near the mitral valve
annulus 14, and a tricuspid valve 16 positioned near the tricuspid
valve annulus 18.
[0030] Various views of the present invention are illustrated in
FIGS. 2A-2E. As shown in FIG. 2A, the self-molding annulus ring 20
comprises a first planar surface 22 and an opposing second planar
surface 24. FIG. 2B shows the annulus ring 20 having a rectilinear
segment 26 and an arcuate segment 28 connected by two curved ends
30 and 32, respectively. As illustrated, the preferred annuloplasty
ring 20 is generally "D" shaped to conform to the shape of a
typical mitral valve annulus. Alternatively, the ring 20 may be
manufactured in any shape suitable for implantation about an
annulus. For example, the present invention may be manufactured in
a generally round or oval shape thereby permitting use of the
present invention to remodel an otherwise incompetent tricuspid
valve. FIG. 2C shows a cross-sectional view of the annuloplasty
ring 20 having an elastic sizing member 36 positioned within an
attachment sheath 38. While the cross-sectional view illustrated in
FIG. 2C is substantially rectangular, it is to be appreciated that
the cross-section can alternatively be of another dimension such as
triangular, circular or any dimension that cooperates with the
native annulus.
[0031] The elastic sizing member 36 preferably comprises a
biologically-compatible materials such as, without limitation,
elastomer, silicon, or any other material having sufficient
resiliency to permit pre-stretching of the annuloplasty ring 20
prior to and during implantation, while having sufficient
contractive force to decrease the size of the valve annulus to a
desired diameter. The attachment sheath 38 provides a suitable
material for suturing or otherwise attaching the annulus ring 20 to
the annulus tissue and promoting tissue growth therein. The
attachment sheath 38 preferably comprises a biologically-compatible
material such as, without limitation, Dacron (polyethylene
terepthalate), polyester knit, PTFE knit, and ePTFE knit. The
attachment sheath may also be treated with a
biologically-compatible tissue growth factor or other medicament to
aid in treating the attachment area. Those skilled in the art will
appreciate that the present invention reduces or eliminates the
occurrence of systolic anterior motion (SAM), wherein the anterior
leaflet of the mitral valve bulges into the left ventricular
outflow track (LVOT) thereby obstructing blood flow into the
aorta.
[0032] An alternate embodiment of the present invention is shown in
FIG. 2D having support members 40 positioned between the sizing
member 36 and the attachment sheath 38. The support members 40 are
preferably fabricated from a biologically-compatible materials
having a comparable modulus of resiliency such as, without
limitation, elastomer, rubber, silicon, or another material having
sufficient resiliency to permit pre-stretching prior to
implantation while providing sufficient support to the valve
annulus. The support member 40 provides additional support of the
valve and valve annulus FIG. 2E shows a perspective view of the
annuloplasty ring of the present invention.
[0033] The annuloplasty ring of the present invention may be
attached to the annulus or surrounding tissue using a plurality of
devices. Referring to FIG. 3A, the annulus ring 20 may be attached
to the valve annulus, either 14 or 18, with sutures 42. FIG. 3B
shows an alternate embodiment of the present invention utilizing
attachment devices positioned on the annuloplasty ring. Like the
previous embodiments, the present embodiment of the ring 44
comprises a rectilinear segment 46 attached to an arcuate portion
48 with two curved ends 50 and 52 positioned therebetween. A number
of attachment devices 54 are positioned around the ring 44 to
facilitate attachment of the ring 44 to the annulus tissue. FIG. 3C
shows the internal materials of the present invention having a
sizing member 56 and an tissue-engaging sheath 58 disposed
thereon.
[0034] Like the previous embodiments, the sizing member 56 is
preferably manufactured from a biologically-compatible material
such as, without limitation, elastomer, silicon, or any other
material having sufficient resiliency to permit pre-stretching of
the annuloplasty ring 44 prior to and during implantation, while
having sufficient contractive force to decrease the size of the
valve annulus to a desired diameter. Similarly, the tissue-engaging
sheath 58 is preferably manufactured from a biologically-compatible
material having comparable resiliency, such as, without limitation,
Dacron (polyethylene terepthalate), polyester knit, PTFE knit, and
ePTFE knit, and may further incorporate tissue growth-enhancing
materials. The attachment device 54 may comprise various
tissue-engaging devices, including, for example, needles, barbs, or
hooks. Those skilled in the art will appreciate the attachment
devices 54 is preferably manufactured from a
biologically-compatible material such as, without limitation,
stainless steel, titanium, or Nickel-Titanium alloy (Nitinol). FIG.
3D shows a perspective view of the annuloplasty ring of the present
embodiment having a plurality of attachment devices 54 positioned
about the device body 44.
[0035] FIGS. 4A-4C show an alternative embodiment of the present
invention that includes size constraining support members. FIG. 4A
shows the annuloplasty ring 60 of the present embodiment in a
contracted state, wherein the ring 60 comprises a rectilinear
segment 62, an arcuate segment 64, and two curved ends 66 and 68
positioned therebetween. The ring 60 is comprised of a series of
support members 70 positioned about the device. The support members
70 are positioned immediately adjacent to each other in the
contracted state, though it is to be understood that the resilient
inner sizing member is biased toward a fully relaxed diameter that
is smaller than the diameter in the contracted state. In other
words, the plurality of support members 70 constrain contraction of
the inner sizing member 72 to a contracted diameter that is larger
than the fully relaxed diameter. FIG. 4B shows the ring 60
stretched prior to implantation, having the resilient inner sizing
member 72 positioned within the support members 70. As shown in
FIG. 4C, each support member 70 has a receiving lumen 74 formed
therein which is capable of receiving the inner sizing member 72.
The attachment sheath 76 may be positioned on the exterior of the
support members 70. Prior to implantation, the ring 60 is
pre-stretched to a fully expanded diameter roughly equivalent to
the diameter of the dilated valve annulus and the attachment sheath
is attached to the tissue using, for example, sutures, staples, or
barbs. Once the ring 60 is suitably positioned with the valve
annulus and attached thereto, the insertion device (not shown) is
removed and the ring 60 contracts causing each size support member
70 to engage the adjacent support members 70, thereby limiting the
degree of contraction that the ring 60 may achieve. Again, the
plurality of support members 70 constrain contraction of the inner
sizing member 72 to a contracted diameter that is smaller than the
fully expanded diameter but larger than the fully relaxed
diameter.
[0036] The support members 70 are preferably manufactured from a
biologically-compatible material such as, without limitation,
stainless steel, titanium, or plastic. Like the previous
embodiment, the inner sizing member 72 is preferably manufactured
from a biologically compatible material such as, without
limitation, elastomer, silicon, or any other material having
sufficient resiliency to permit pre-stretching of the annuloplasty
ring 60 prior to and during implantation, while having sufficient
contractive force to decrease the size of the valve annulus to a
desired diameter. Similarly, the attachment sheath 76 is preferably
manufactured from a resilient biologically-compatible material such
as, without limitation, Dacron (polyethylene terepthalate),
polyester knit, PTFE knit, and ePTFE knit, or may incorporate
tissue growth-enhancing materials.
[0037] The present invention further discloses a method of
repairing a dilated or otherwise incompetent annulus. An exemplary
open-chest surgical repair of a mitral valve will be disclosed
herein. It should be understood the method disclosed herein is not
intended to limit the scope of the present invention in any
way.
[0038] The mitral valve partially forms the atrio-ventricular
junction between the left atrium and left ventricle of the heart
and is most easily reached through the wall of the left atrium.
Those skilled in the art will appreciate that the wall of the left
atrium is may be accessed through a medial stemotomy procedure. To
gain access to the mitral valve during the stemotomy, the surgeon
rotates the heart to an anterior position, thereby providing access
to the left atrium. An incision is made in the left atrium, thereby
providing access to the mitral valve and the valve annulus.
[0039] To insert the annuloplasty ring of the present invention,
the ring 20 is stretched for positioning on an insertion device.
Those skilled in art will appreciate the present invention may be
inserted on a plurality of insertion devices know in the art.
Additionally, the annuloplasty ring may be positioned on the
insertion device at the time of manufacture or immediately prior to
implantation. Ideally, the annuloplasty ring should be stretched to
a size commensurate with the diameter of the dilated valve annulus.
The ring, positioned on the insertion device, is positioned
proximate to the valve annulus and attached to surrounding tissue
in a plurality of known and accepted manners, including, suturing,
stapling, or any other biologically-compatible attachment
technique. With the ring sufficiently attached, the insertion
device is removed, resulting in the annuloplasty ring contracting
to its pre-stretched diameter, thereby rendering the valve
competent. Those skilled in the art will appreciate the contractive
force of the annuloplasty ring will determine the amount of
post-implantation valvular dilation, thereby permitting the surgeon
to accurately predict the post-implantation valve diameter.
[0040] While the foregoing describes the preferred embodiments of
the invention, various alternatives, modifications, and equivalents
may be used. By way of example but not of limitation, alternative
insertion devices, and alternative attachment devices may be used.
It will thus be obvious that certain other modifications may be
practiced within the scope of the appended claims.
* * * * *