Title: Valve repair device
Abstract: A valve repair device and method of repair for the mitral valve of the heart is disclosed. The valve repair device includes a leaflet portion, a muscle portion, and a plurality of chords connecting the leaflet portion to the muscle portion. The valve repair device is attached to the diseased valve by suturing the leaflet portion to the affected leaflet and suturing the muscle portion to the affected muscle. The leaflet portion and muscle portion are constructed of cloth made from expanded polytetraflouroethylene. The chords are sutures also constructed from expanded polytetraflouroethylene. The suture position for the muscle portion is determined by positioning the valve repair device adjacent to a normal marginal chord. The valve repair device may be employed to repair the anterior leaflet or posterior leaflet of the mitral valve.
Patent Number: 6,997,950 Issued on 02/14/2006 to Chawla
| Inventors:
|
Chawla; Surendra K. (26 Balfour Dr., West Hartford, CT 06117)
|
| Appl. No.:
|
345750 |
| Filed:
|
January 16, 2003 |
| Current U.S. Class: |
623/2.1; 623/13.11; 606/151 |
| Current Intern'l Class: |
A61F 2/24 (20060101) |
| Field of Search: |
623/21,211-219,236,24,131.1
606/151,139,228,213,232
|
References Cited [Referenced By]
U.S. Patent Documents
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| |
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| |
| 5415667 | May., 1995 | Frater.
| |
| 5554184 | Sep., 1996 | Machiraju.
| |
| 5662704 | Sep., 1997 | Gross.
| |
| 6074417 | Jun., 2000 | Peredo.
| |
| 6143025 | Nov., 2000 | Stobie et al.
| |
| 6312447 | Nov., 2001 | Grimes.
| |
| 6332893 | Dec., 2001 | Mortier et al.
| |
| 6338240 | Jan., 2002 | Endo et al.
| |
| 6350282 | Feb., 2002 | Eberhardt.
| |
| 6358277 | Mar., 2002 | Duran.
| |
| 6409759 | Jun., 2002 | Peredo.
| |
| 6726715 | Apr., 2004 | Sutherland.
| |
| 6764510 | Jul., 2004 | Vidlund et al.
| |
| 6797002 | Sep., 2004 | Spence et al.
| |
| 2003/0105519 | Jun., 2003 | Fasol et al.
| |
| 2004/0106989 | Jun., 2004 | Wilson et al.
| |
| 2004/0122513 | Jun., 2004 | Navia et al.
| |
| 2004/0138745 | Jul., 2004 | Macoviak et al.
| |
| 2005/0010287 | Jan., 2005 | Macoviak et al.
| |
| 2005/0107871 | May., 2005 | Realyvasquez et al.
| |
Other References
"Long-Term Results of Mitral Valve Repairs for Myxomatous Disease With and Without
Chordal Replacement With Expeanded Polytetrafluoroethylene Sutures"; Authors: Tirone
e, David, MD, Ahmad Omran, MD, Susan Armstrong, MSc, Zhao Sun, PhD, Joan Ivanov,
MSc; pp. 1279-1286; The Jornal of Thoracic and Cardiovascular Surgery; Jun. 1998.
|
Primary Examiner: McDermott; Corrine
Assistant Examiner: Miller; Cheryl
Attorney, Agent or Firm: Cantor Colburn LLP
Claims
What is claimed is:
1. A device for repair of a valve of a heart comprising:
a first portion, said first portion comprising a flexible element, said flexible
element having an outer periphery, said outer periphery having an attachment area,
a second portion, said second portion comprising a flexible element,
at least one chord, said chord having opposite ends, one of said ends being attached
to said first portion, the other of said ends being attached to said second portion,
a first suture adapted to connect said first portion at least partially along
said outer periphery at said attachment area to the native leaflet of a heart valve,
wherein said first portion is configured to at least partially cover an opening,
wound or defect in said leaflet, and
a second suture adapted to connect said second portion to the papillary muscle
of a heart.
2. The device of claim 1, wherein said first portion comprises a cloth made of
expanded polytetraflouroethylene.
3. The device of claim 1, wherein said at least one chord is a plurality of chords,
each of said chords having opposite ends, one of each said ends being attached
to said first portion, the other of each said ends being attached to said second portion.
4. The device of claim 3, wherein said chords being attached at one of each said
ends to said first portion adjacent said outer periphery.
5. The device of claim 4, wherein said outer periphery is rounded.
6. The device of claim 3, wherein said chords are sewn to said first portion
and to said second portion.
7. The device of claim 3, wherein said second suture is affixed at a first end
to said second portion.
8. The device of claim 1, wherein said at least one chord are made of expanded polytetraflouroethylene.
9. The device of claim 1, wherein said outer periphery of said first portion
is rounded.
10. The device of claim 1, wherein said second portion comprises a cloth made
of expanded polytetraflouroethylene.
11. A method for repairing a heart valve, comprising:
providing a device for repairing a heart valve, said device having a first portion,
said first portion comprising a flexible element, said flexible element having
an outer periphery, said outer periphery having an attachment area,
a second portion, said second portion comprising a flexible element, at least
one chord, said chord having opposite ends, one of said ends being attached to
maid first portion, the other of said cads being attached to said second portion;
suturing said first portion at least partially along said outer periphery to
the native leaflet of a valve at said attachment area, wherein said first portion
at least partially covers an opening, wound or defect in said leaflet; and
suturing said second portion to a papillary muscle.
12. The method of claim 11 further comprising removing part of said first portion
prior to suturing said first portion to the leaflet.
13. The method of claim 11 further comprising removing part of said chord prior
to suturing said first portion to the leaflet.
14. The method of claim 11, wherein said first portion comprises a cloth made
of expanded polytetraflouroethylene.
15. The method of claim 11, wherein said at least one chord is a plurality of
chords, each of said chords having opposite ends, one of each said ends being attached
to said first portion, the other of each said ends being attached to said second portion.
16. The method of claim 11, wherein said at least one chord being attached at
one of each said ends to said first portion adjacent said outer periphery.
17. The method of claim 11, wherein said at least one chord are sewn to said
first portion and to said second portion.
18. The method of claim 11, wherein said second portion comprises a suture having
a first end attached to said second portion and a second end having a needle attached thereto.
19. The method of claim 11, wherein said first portion includes a rounded edge,
said edge being attached adjacent to the scalloped edge of the leaflet.
20. The method of claim 11, wherein said outer periphery is rounded.
Description
BACKGROUND OF THE INVENTION
The present disclosure relates to a valve repair device and a method for repairing
a heart valve. More particularly, this disclosure relates to a valve repair device
useful in the repair of the mitral valve.
The human heart has four chambers and four one way valves. The right upper chamber,
known as the right atrium, receives deoxygenated blood from the body and passes
the blood to the right lower chamber, known as the right ventricle, through the
tricuspid valve. The blood then passes through the pulmonary valve and is carried
via the pulmonary arteries to the lungs for oxygenation. After the blood is oxygenated,
it is received into the left side of the heart. The upper chamber, known as the
left atrium, receives the blood from the lungs by four pulmonary veins, two from
each lung. The blood is then passed to the left ventricle through the mitral valve.
The main pumping chamber, the left ventricle, then pushes the blood to the body
through the aortic valve.
The mitral valve is also known as a bicuspid valve, as it has two cusps or leaflets.
The leaflets consist of the anterior leaflet, which is located adjacent to the
aortic valve, and the posterior leaflet. The anterior leaflet is larger than the
posterior leaflet. At the junction of the leaflets, each leaflet has a scalloped
edge with three rounded portions, known as A
1, A
2, and A
3
for the anterior leaflet, and P
1, P
2 and P
3 for
the posterior leaflet. The leaflets are attached to the papillary muscles by the
chordae tendineae. The papillary muscles maintain the integrity of chordal leaflet
alignment, preventing prolapse of the leaflets. The mitral valve allows blood to
flow from the left atrium to the left ventricle but prevents blood from flowing
back to the left atrium.
The tricuspid valve and the pulmonary valves are usually less affected by the
disease process. Disease in the mitral valve and the aortic valve is more common
in the affected adult population.
Mitral valve stenosis, for example, consists of an obstructive lesion to the
leaflets of the valve. When the valves are narrow, also called "stenotic" valves,
there is an obstruction to the flow of blood to the receiving chamber and an associated
back up of blood. Dilatation of the left atrium develops and may be followed by
right-sided heart failure and pulmonary edema, causing lung congestion and symptoms
of shortness of breath. If the symptoms are severe, surgical intervention may be warranted.
Thickening and calcification is the commonest cause of narrowing of the
mitral valve, secondary to the long-term effects of rheumatic disease. The incidence
of mitral stenosis has decreased in the United States as the incidence of rheumatic
fever has decreased as a result of the early institution of antibiotics. However,
the leaking valve or the regurgitant valve incidence has increased in the last
two decades. Mitral regurgitation is commonly due to degeneration or myxomatous
disease leading to the lack of coaptation of the two mitral leaflets. The lack
of coaptation in turn leads to the blood being regurgitated into the left upper
chamber or the left atrium, causing pulmonary congestion and shortness of breath.
Other causes include rupture of the chordae tendinea or the papillary muscles which
are primarily needed to the support the two leaflets. Infection leading to the
destruction of the valve leaflet or congenital clefts can also cause mitral regurgitation.
Treatments for these conditions have varied. Opening of the mitral valve
was initiated in the 1950's in a closed method, known as a closed commisurotomy
(separation of commisures by dialators). With the advent of heart-lung machine
in 1955-56 by Dr. John H. Gibbons, Jr., open mitral comrnisurotomy was started
with success.
Due to the high recurrence of stenosis, mitral valve replacement with prosthetic
valves, typically constructed of a "ball and cage" (or ball valve), became the
normal procedure in the 1960's, as proposed by Dr. Albert Starr. These valves were
met with limited success as blood flow obstruction occurred with some frequency,
leading to thromboembolism, causing strokes. Other attempts to replace the mitral
valve were met with limited success. For example, Bjork Shiley valves were introduced
as tilting disc valves to decrease the blood flow obstruction, but a flaw in the
design led to strut fracture and their discontinuation. St. Jude valves, with a
double tilting disc design, were introduced in the late 1970's. These valves have
stood the test of durability and acceptable thromboembolism and are the preferred
prosthetic valve replacement in the younger population.
Bioprothesis valves, harvested from heterologous mammals, such as swine
and bovine, have also been successfully employed, however, such valves frequently
wear out due to degeneration and calcification. Moreover, the current designs for
the mitral valve are somewhat limited due to the specific VORTEX flow of the left
ventricle. U.S. Pat. No. 6,074,417 illustrates a total bioprosthesis mitral valve.
When possible, surgical repair of the defective valve is preferable over the
prosthetic replacement. The thrust of surgical repair has been to preserve the
integrity of the papillary muscle, the chordae tendineae and the leaflets. Numerous
studies have proved this hypothesis in terms of long-term results and the avoidance
of anticoagulation, which can cause life-threatening bleeding complications. In
the 1980's, Dr. A F Carpentier of France, pioneered several methods to repair the
mitral valve. Rupture of the chordae or the prolapse of the middle scallop of the
posterior leaflet was easily repaired by excising the diseased piece, repairing
the annulas, and suturing the two leaflets. This procedure has become a preferred
method and has produced consistent results. These repairs are supported by the
placement of a cloth-covered metallic ring to bring the annulus to the near normal level.
Despite the advancement in the surgical management of the posterior leaflet,
the repair of the anterior mitral leaflet has proven more difficult. Various surgical
techniques have been devised, but without consistent results. Triangular resection
of the leaflet, transposing part of the posterior leaflet to the anterior leaflet,
chordal shortening have been proposed. Recently the use of the prosthetic material
"goretex" sutures have been used as artificial chordae, with some early success.
Long Term Results of Mitral Valve Repair for Myxomatous Disease with and without
Chordal Replacement with Expanded Polytetrafluoroethylee, The Journal of Thoracic
and Cardiovascular Surgery, June 1998, 1279-1286.
The use of prosthetic sutures for the anterior or posterior leaflet requires
a great deal of skill on the part of the surgeon to make sure the sutures, duplicating
the chords, are of the appropriate length. Moreover, attachment of the sutures
to the leaflets and papillary muscles is delicate and cumbersome.
BRIEF SUMMARY OF THE INVENTION
The above discussed and other drawbacks and deficiencies are overcome or alleviated
by a valve repair device having a leaflet portion, a muscle portion, and a plurality
of chords connecting the leaflet portion to the muscle portion.
The valve repair device is attached to the diseased valve by suturing the leaflet
portion to the affected leaflet and suturing the muscle portion to the affected muscle.
As an additional feature, the leaflet portion and muscle portion are constructed
of cloth made from expanded polytetraflouroethylene. The chords are sutures also
constructed from expanded polytetraflouroethylene.
As an additional feature, the leaflet portion or muscle portion include a reinforced
attachment point for the sutures.
As an additional feature, the valve repair device may cut by the surgeon to eliminate
unnecessary area in the leaflet, or to eliminate an excess number of chords.
BRIEF DESCRIPTION OF THE DRAWINGS
Referring to the FIGURES wherein the like elements are numbered alike in
the several FIGURES
FIG. 1 shows a prospective view of the valve repair device;
FIG. 2 illustrates a prior art cross sectional view of the heart, illustrating
the mitral valve of the heart;
FIG. 3 shows a perspective view of the valve repair device sutured in the mitral valve;
FIG. 4 shows an exploded view of the placement of the valve repair device to
the repair site of an affected leaflet;
FIG. 5 shows a perspective view of the valve repair device sutured to an affected
leaflet and papillary muscle;
FIG. 5
a shows a perspective view of the valve repair device sutured to
an affected leaflet and papillary muscle in the heart;
FIG. 6 shows a perspective view of the valve repair device sutured to the anterior leaflet;
FIG. 7 shows a perspective view of the valve repair device sutured to the posterior leaflet;
FIG. 8 shows a prospective view of another use of the valve repair device;
FIG. 9 shows a prospective view of another use of the valve repair device;
FIG. 10 shows a prospective view of another use of the valve repair device;
FIG. 11 shows a prospective view of another use of the valve repair device;
FIG. 12 shows another embodiment of the valve repair device; and
FIG. 13 shows another embodiment of the valve repair device
DETAILED DESCRIPTION OF THE DRAWINGS
Referring to FIG. 1, a valve repair device
10 in accordance with
the present invention is illustrated. Valve repair device
10 includes a
leaflet portion
12. A plurality of chords
14 extend from the leaflet
portion
12 and are attached to the leaflet portion
12 adjacent end
16 at a plurality of attachment locations
18. Chords
14 connect
leaflet portion
12 to a muscle portion
20 at a plurality of respective
attachment locations
22 adjacent end
24 of muscle portion
20.
Leaflet portion
12 is a thin flexible element preferably constructed
of a biocompatible cloth. Preferably, leaflet portion
12 is constructed
of a plastic reinforced cloth, such as expanded polytetraflouroethylene. Gor-Tex®,
produced by W. L. Gore and Associates, Inc., Flagstaff, Ariz., is an example of
a suitable biocompatible cloth made from expanded polytetraflouroethylene. Leaflet
portion
12 provides an anchor to the leaflet of a valve of the heart for
chords
14, and may essentially replicate the leaflet, if the leaflet is
diseased. Chords
14 are preferably constructed from suture material, such
as expanded polytetraflouroethylene, such as GorTex® 5-0 ePTFE and/or 6-0
ePTFE. Leaflet portion
12 is sized for repair of the anterior or posterior
leaflet, and more specifically, to cover excised diseased material, such as after
a resection of a segment of a floppy valve, either a posterior or anterior leaflet.
End
16 may be rounded as the posterior and anterior leaflets are scalloped
shaped. More preferably, leaflet portion
12 is rounded at its outer periphery,
in a similar manner to the natural leaflets.
Muscle portion
20 is likewise a flexible element and preferably constructed
of a biocompatible cloth. Preferably, muscle portion
20 is constructed of
expanded polytetraflouroethylene, such as Gor-Tex®. Muscle portion
20
has a rounded portion
24, and is sized to be attached to the papillary muscle
of the heart. Muscle portion
20 provides an anchor for chords
14
to the papillary muscle. Muscle portion includes a pair of sutures
26 attached
to muscle portion
20, with needles
28 attached at the free end of
the sutures
26. Muscle portion
20 may be cylindrically shaped to
surround the papillary muscle.
Chords
14 connect leaflet portion
12 and muscle portion
20
and function as the chordae tendineae as explained in greater detail below. Chords
14 are sewn to leaflet portion
12 and muscle portion
20 at
respective attachment locations
18 and
22, and maybe reinforced by
weaving chords
14 into the weave pattern of leaflet portion
12 and
muscle portion
20. Alternatively, chords
14 may be fastened on leaflet
portion
12 or muscle portion
20, such as with a plastic clip or as
a contiguous part of the cloth or prosthetic material.
Referring to FIGS. 2 and 3, the repair of the posterior leaflet of the
mitral valve of the heart with valve repair device
10 is illustrated. As
shown in prior art FIG. 2, the chordae tendineae are attached to the respective
posterior leaflet or anterior leaflet and connect the leaflet to the papillary
muscle. During a typical repair of the mitral valve, the diseased portion of the
valve is excised, such as the elongated portion of a chordae or a ruptured chordae,
and the remaining leaflet material is then sutured together. If the chordae tendoneae
is diseased, it may also be excised, with sutures connecting the leaflet to the
papillary muscle. As shown in FIG. 3, and in accordance with the present invention,
valve repair device
10 is directly sutured to the mitral valve with suture
30 attaching leaflet portion
12 along its outer periphery to the
affected leaflet and sutures
26 attaching muscle portion
20 to the
affected papillary muscle so that chords
14 replicate the chordae tendineae.
Leaflet portion
12 is sutured over the excised diseased material with sutures
30, thereby reducing the impact to the leaflet and its function that is
associated with the prior art method of reconnecting the leaflet at the point of excision.
Turning now to FIGS. 3 and 4, during open-heart surgery, the physician will
assess the degree of disease, and determine the extent of the repair to the mitral
valve needed. The surgeon will first excise the diseased material, such as the
elongated scallop portion of a leaflet, the perforated portion of the leaflet,
the affected chordae tendineae, etc. An annular ring may be used to reinforce the
mitral valve. Next, the surgeon will determine the size of the valve repair device
10 needed to effectuate the repair and may reduce leaflet
12 by cutting,
such as illustrated by line
32, unneeded area
34 from leaflet portion
12. The physician also cuts unneeded chords
14, such as illustrated
by lines
36.
Referring to FIGS. 5 and 5
a, the surgeon sutures leaflet portion
12 over the affected area of the posterior or anterior leaflet with sutures
30 such that end
16 is positioned near the edge of the leaflet. Next,
the surgeon sutures muscle portion
20 to the papillary muscle with sutures
26. Prior to suturing muscle portion
20 to the papillary muscle,
the surgeon must determine the distance or location, as illustrated by dimension
D, to achieve an effective repair such that the leaflets will open and close effectively.
It is important that the leaflet be spaced at a length, as illustrated by dimension
L, from the papillary muscle so that the leaflet is positioned properly to open
and close effectively. Failure to accurately determine the location for muscle
portion
20 may result in an ineffective repair, causing prolapse of the
leaflet, which in turn may cause the valve to leak.
In order to accurately determine the location, as illustrated by dimension D,
the surgeon may estimate the needed chord length by comparing the relative length
of the adjoining chords. The chordae tendeneae comprise the marginal chord, the
secondary chord and the basilar chord. The marginal chord is located adjacent the
margin or edge of the respective anterior or posterior leaflet. The basilar chord
is located adjacent to the area adjoining the annulus of the mitral valve and the
secondary chord is positioned between the marginal chord and the basilar chord.
Disease in the mitral valve is typically associated with the marginal chord. Subsequent
to its removal, the surgeon may approximate the needed chord length, as illustrated
by dimension L, by positioning the valve repair device adjacent to a normal marginal
chord. The surgeon may also reference the chord length of the opposing anterior
or posterior leaflet chordae tendeneae. Preferably, the surgeon will suture a holding
stitch or a stay suture between the anterior and posterior leaflets at the level
of adjoining normal chordae to obtain accurate approximation of the desired chord
length. In this manner, the surgeon may suture muscle portion
20 to the
papillary muscle at a distance D to achieve the desired location to effectuate
a repair.
It should be understood by those of ordinary skill in the art that the surgeon
could suture muscle portion
20 to the papillary muscle with sutures
26
and then suture leaflet portion
12 to the leaflet with sutures
30,
provided that the location of leaflet portion
12 and muscle portion
20
allows the leaflets to open and close effectively.
As illustrated in FIGS. 6 and 7, valve repair device
10 may be used to
repair the anterior leaflet or the posterior leaflet, by positioning leaflet portion
such that end
16 is positioned along the outer edge of the leaflet to be
repaired. Moreover, valve repair device
10 may be offered in a variety of
sizes and specifically in a kit form. Prior to undertaking the repair of the mitral
valve, the surgeon will typically be acquainted with patient's specific physiology.
During the open-heart operation, time is an important factor, and a surgeon may
be confronted with an unknown defect in the valve. In use, valve repair device
10 eliminates the bulky process of affixing sutures from the papillary muscle
to the respective posterior or anterior leaflet. Leaflet portion
12 is sutured
directly to the leaflet with sutures
30, and muscle portion
20 is
sutured directly to the papillary muscle with sutures
26. The surgeon may
easily modify the size of valve repair device
10 by cutting excess areas
from leaflet
12 and/or muscle portion
20, saving time. Moreover,
the ease of attaching leaflet portion
12 to the leaflet as well as attaching
muscle portion
20 to the papillary muscle increases the surgeon's ability
to obtain the effective opening and closure of the valve, as the tedious and more
imprecise process of attaching sutures as chords is eliminated. The anterior leaflet
of the mitral valve is particularly difficult to repair given its proximity to
the aortic valve. The instant invention allows the surgeon to suture leaflet portion
to the anterior leaflet without affecting the aortic valve.
Referring now to FIG. 8, another use of valve repair device
10 is
illustrated. In use, the surgeon may encounter a leaflet with multiple diseased
areas but which is stable enough to sustain a repair as opposed to a total replacement
of the mitral valve. Leaflet portion
12 is cut for application to the affected
areas. Leaflet portion
12 may be cut into separate parts,
12a
and
12b, as shown, with each part connected to muscle portion
20 by chords
14. Leaflet portions
12a and
12b
are sutured to the affected areas of the leaflet to be repaired with suture
30. Unnecessazy chords
14 may be cut by the surgeon. Muscle portion
20 is attached to the papillary muscle as previously discussed above.
As shown in FIG. 9, another use of valve repair device
10 is illustrated.
Leaflet portion
12 has been cut to effectuate the repair of a healed perforation
of a leaflet secondary to endocorditis. In this use chords
14 and muscle
portion
20 have been removed from leaflet portion
12. Leaflet portion
12 has been sutured over the perforation with suture
30.
Turning now to FIG. 10, another use of valve repair device
10 is illustrated.
Leaflet portion
12 has been cut to effectuate the repair of a healed perforation
of a leaflet secondary to endocorditis. Chords
14 remain attached to leaflet
portion
12 and connect leaflet portion
12 to muscle portion
20.
Leaflet portion
12 is sutured over the perforation with suture
30
along most of the periphery of the cut leaflet portion
12. Muscle portion
20 is attached to the papillary muscle with sutures
26.
Referring now to FIG. 11, another use of valve repair device
10
is illustrated. It will be appreciated that a surgeon may be presented with a patient
having disease in both the anterior leaflet and posterior leaflet which lends itself
to a dual repair of the anterior leaflet and the posterior leaflet. In this use,
leaflet portion
12 is cut by the surgeon into two pieces
38 and
40,
as shown. Piece
38 is folded such that end
16 is position along the
edge of the anterior leaflet. Piece
40 is folded such that end
16
is positioned along the edge of the posterior leaflet. After sutured pieces
38
and
40 to the respective leaflets, the surgeon may position the valves in
the closed position and approximate the needed chord length by positioning the
valve repair device adjacent to the secondary or basilar chord, as discussed above.
The surgeon may also employ a stay stitch to temporarily connect muscle portion
20 to the papillary muscle.
As shown in FIG. 12, another embodiment of valve repair device
10 is illustrated.
Valve repair device
10 includes leaflet portion
12, chords
14,
and muscle portion
20 as in the first embodiment. Is this embodiment, two
pairs of attached sutures
26 with needles
28 are provided for attachment
of muscle portion
20 to the papillary muscle. It will be appreciated by
those of ordinary skill in the art that additional sets of sutures
26 and
needles
28.
As shown in FIG. 13, another embodiment of the valve repair device is shown at
50. Valve repair device
50 includes a leaflet portion
52.
A plurality of chords
54 extend from the leaflet portion
52 and are
attached to the leaflet portion
52 adjacent end
56 at a plurality
of attachment locations
58. Chords
54 connect leaflet portion
52
to a muscle portion
60 at a plurality of respective attachment locations
62 adjacent end
64 of muscle portion
60. Muscle portion includes
a pair of sutures
66 attached to muscle portion
60, with needles
68 attached at the free end of the sutures
66. Muscle portion
60
is sutured to the papillary muscle along a portion of the muscle. Leaflet portion
52 and muscle portion
60 are made of a flexible material, as described above.
While the invention has been described with reference to a preferred embodiment,
it will be understood by those skilled in the art that various changes may be made
and equivalents may be substituted for elements thereof without departing from
the scope of the invention. In addition, many modifications may be made to adapt
the invention to a particular situation or material to the teachings of the invention
without departing from the essential scope thereof. Therefore, it is intended that
the invention not be limited to the particular embodiment disclosed as the best
mode contemplated for carrying out this invention, but that the invention will
include all embodiments falling within the scope of the appended claims.
*