Surgery – Miscellaneous – Methods
Reexamination Certificate
1999-09-17
2001-06-26
Willse, David H. (Department: 3738)
Surgery
Miscellaneous
Methods
C623S002360, C623S904000
Reexamination Certificate
active
06250308
ABSTRACT:
BACKGROUND
The present invention is directed to a mitral valve annuloplasty ring and a method for implanting a mitral valve annuloplasty ring to treat mitral insufficiency in a patient. Mitral insufficiency, also known as mitral regurgitation, is a common cardiac abnormality wherein the heart's mitral valve does not properly close.
In a normally functioning heart, oxygenated blood passes from the left atrium through the opened mitral valve and into the left ventricle when the left ventricle is in a relaxed state. When the left ventricle contracts, the blood is pushed out of the left ventricle thereby closing the mitral valve to prevent blood flowing back or regurgitating into the left atrium. From the left ventricle, the oxygenated blood is pumped out of the heart and directed to the rest of the body.
With mitral insufficiency, the mitral valve does not fully close and a portion of blood leaks back into the left atrium when the left ventricle contracts. As a result, the heart has to work harder by pumping not only its regular volume of blood, but also the extra volume of blood that regurgitates back into the left atrium. The added workload creates an undue strain on the left ventricle. This strain can eventually wear out the heart and result in death when the condition is prolonged and severe enough. Consequently, a properly functioning mitral valve is critical to the pumping efficiency of the heart.
Mitral valve annuloplasty is a well known approach for treating mitral insufficiency, although other treatments are used which include replacing the mitral valve, repairing the mitral valve leaflets, and shortening or replacing the chordae tendinae. Mitral valve annuloplasty is the reparation of the mitral valve annulus which effects full closure of the leaflets by reestablishing the size and shape of the normal mitral valve annulus. Such an annuloplasty most commonly incorporates the use of a mitral annuloplasty ring wherein the ring is implanted on the mitral valve annulus.
There are three basic types of mitral annuloplasty rings used in annuloplasty procedures. They include a rigid ring, a flexible ring and a combined ring that has both a flexible component and a rigid component.
Due to their inflexibility, the rigid rings dictate the shape and contour of the mitral valve. The native mitral valve annulus flexes in response to the movement of the heart. However, with a rigid ring the annulus is not able to flex normally or move freely with the pumping action of the heart. As a result of the rigidity, the physiologic factors that normally shape the mitral valve annulus are not allowed to take precedence in shaping the valve.
Another drawback with rigid rings is that they can induce a heart condition known as systolic anterior motion in patients having a mitral valve posterior leaflet that is too “tall”. During ventricular contraction, the posterior leaflet pushes the anterior leaflet in a direction opposite to the anterior leaflet's normal movement, resulting in the obstruction of the left ventricle's outflow tract.
Overall, rigid annuloplasty rings do not allow the mitral valve annulus to reestablish its normal shape and form as dictated by the action of the heart pumping. The shape and contour of the annulus is established by the inflexible shape and form of the ring itself.
Flexible rings made of Dacron cloth, unlike the rigid rings, can allow the mitral valve annulus to move and flex as the heart contracts and relaxes. However, several drawbacks still exist. Proper shape and contour of the annulus is necessary in order for the mitral valve leaflets to close effectively. One shortcoming of the flexible ring is its predisposition to crimp during implantation. Crimping can be detrimental to the valve annulus, sometimes resulting in a mitral orifice that is too small. This can lead to stenosis of the valve. Furthermore, neither the flexible rings nor the combined rings will remain flexible indefinitely after annuloplasty. Since the rings are secured in place by a line of sutures attached directly to the annulus, scarring and resultant stiffening of the annulus inevitably develops. This loss of flexibility impedes the normal flexing and movement of the heart, particularly the left ventricle and, therefore, the heart cannot function optimally.
SUMMARY
The annuloplasty ring of the present invention is a combined ring which comprises a first section that is substantially rigid and a second flexible section. The ring can be readily adjusted to fit the annulus of any particular patient. The method of implanting the annuloplasty ring of the present invention comprises installing a ring within the fat pad of the atrioventricular groove which surrounds the mitral valve annulus. The method does not require a series of sutures extending through the mitral valve annulus tissue to hold the ring in place. Resultant scarring and stiffening of the annulus is thereby substantially eliminated.
The ring of the present invention when combined with the method of the present invention is positioned in the fat pad of the atrioventricular groove adjacent to the mitral valve annulus. The flexible section of the ring extends adjacent to the flexible posterior portion of the annulus, while the rigid section of the ring spans the substantially rigid inter-trigone section of the annulus. Since the flexible section of the ring is held in the atrioventricular groove of the posterior section of the annulus, it is not necessary to suture the flexible section directly to the mitral valve annulus. As a result, scarring of the annulus is substantially eliminated, thereby allowing the ring and annulus to remain flexible indefinitely. As in the normal heart, this flexibility enables the mitral valve annulus to flex in several planes during contraction and relaxation of the heart. The result is better postoperative functioning of the mitral valve and better postoperative functioning of the left ventricle, as well.
It is an object of the present invention to provide an annuloplasty ring that reestablishes the normal shape and contour of the mitral valve annulus.
It is a further object of the present invention to provide a method for performing an annuloplasty that substantially eliminates scarring of the mitral valve annulus tissue to preclude the loss of flexibility following the annuloplasty.
It is a further object of the present invention to provide a method for implanting the annuloplasty ring that allows the ring to maintain flexibility indefinitely.
It is a further object of the invention to provide an annuloplasty ring that is flexible enough to allow the mitral valve and annulus to flex through different planes, yet positioned such that the shape and contour of a normal mitral valve annulus is reestablished.
It is a further object of the present invention to provide a flexible annuloplasty ring that does not crimp during implantation.
It is a further object of the present invention to provide an annuloplasty ring that can be flexed in all manner that the native mitral valve annulus flexes.
It is a further object of the present invention to provide an annuloplasty ring and method of implanting the ring that maintains flexibility of the ring and the mitral valve annulus indefinitely.
It is a further object of the present invention to provide a method for implanting the annuloplasty ring that minimizes scarring of the mitral valve annulus and nearby tissue.
It is a further object of the present invention to provide an annuloplasty ring that assumes the shape of the normal mitral valve annulus to allow for effective functioning of the valve.
It is a further object of the present invention to provide an annuloplasty ring and method of implanting the ring that result in effective coaptation of the anterior and posterior leaflets of the mitral valve.
It is a further object of the present invention to provide an annuloplasty ring and method of implanting an annuloplasty ring that do not impede the movement of the left ventricle's base when the ventricle is contracting and relaxing, thereby allowing
Cardiac Concepts, Inc.
Cox Boyd D.
Jackson Suzette J.
Willse David H.
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