Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Heart valve – Flexible leaflet
Reexamination Certificate
1999-12-30
2002-06-25
Isabella, David J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Heart valve
Flexible leaflet
C623S900000
Reexamination Certificate
active
06409759
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to prosthetic heart valves. More particularly, the invention relates to prosthetic heart valves for the replacement of damaged. mitral or tricuspid heart valves.
Heart valve insufficiency can be a debilitating and possibly life threatening condition. For example, heart valve regurgitation, i.e., backward leakage of blood at a heart valve, results in reduced pumping efficiency. With respect to mitral valve. regurgitation, compensatory mechanisms such as hypeirtrophy and dilation of the ventricle suggest early treatment to prevent progressive deterioration of ventricular function. Diagnosis of mitral regurgitation can be performed using visualization with transesophageal echocardiography or by echocardiography. In particular, defective leaflet coaptation and the site and direction of he regurgitant flow can be examined to evaluate likely modes of failure.
Mitral valve prolapse, i.e., myxomatous degeneration of mitral valve leaflets, is the most common cause of mitral regurgitation in North America. Rheumatic heart disease was the most common cause of mitral regurgitation in the United States thirty years ago and is still the most common cause of mitral regurgitation in developing countries. Chronic rheumatic heart disease results in retraction, deformity and rigidity of one or both mitral valve cusps as well as structural abnormalities in the commissures, chordae tendineae and papillary muscles. Ischemic mitral regurgitation (IMR), i.e., anemia of the valve tissue due to reduced arterial blood flow feeding the valve tissue, is the second most common cause of mitral valve regurgitation. Studies suggest that annular irregularities and posterior papillary muscle fibrosis with scarring of the underlying ventricular wall may be associated with IMR.
Many cases of mitral regurgitation can be repaired by modifications of the original valve in a procedure generally referred to as valvuloplasty. For example, one repair technique uses an annuloplasty ring to provide structural support to the natural annulus of the native valve. For severe cases of heart valve damage, however, reconstructive valvular surgery may not be possible. In such cases, valve replacement may be required.
Physicians use a variety of prostheses to correct problems associated with the cardiovascular system, especially the heart. For example, the ability to replace or repair diseased heart valves with, prosthetic devices has provided surgeons with a method of treating heart valve deficiencies due to disease and congenital defects. A typical procedure involves removal of the native valve and surgical replacement with a prosthetic heart valve.
Both mechanical heart valve prostheses and tissue based heart valve bioprostheses have been used to replace damaged heart valves. Mechanical heart valves have the advantage of better durability, but patients with mechanical heart valves generally are required to use anticoagulants throughout their lifetimes. Anticoagulants have associated risks, such as hemorrhages, embolism and thromboembolism. Tissue based bioprostheses do not require the long term use of anticoagulants due to a lower incidence of thromboembolism.
SUMMARY OF THE INVENTION
In a first aspect, the invention pertains to a heart valve prosthesis comprising a harvested tissue heart valve with integral leaflets. The heart valve has an annulus at one end of the valve, and a sewing rim extends outwardly from the annulus.
In another aspect, the invention pertains to additional embodiments of a heart valve prosthesis comprising a harvested tissue heart valve with integral leaflets. The heart valve has an annulus at one end of the valve, and a belt secured around at least a substantial portion of an outer circumference of the annulus of the harvested tissue heart valve.
In a further aspect, the invention pertains to still further embodiments of a heart valve prosthesis comprising a harvested tissue heart valve with integral leaflets. The harvested tissue heart valve has an annulus at one end of the valve, and pledgeted suture constricts a portion of the circumference of the annulus.
Moreover, the invention pertains to a method of producing a heart valve prosthesis comprising a harvested tissue heart valve with integral leaflets, the heart valve having an annulus at one end of the valve, the method comprising attaching a sewing rim extending outward from the surface annulus of the harvested tissue heart valve.
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“New Horizons and the Future of Heart Valve Bioprostheses” by, Vetter et al., First Edition, 1994, pp. 93-104.
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International Search Report (PCT/US00/42199) dated Oct. 12, 2001.
Chattopadhyay Urmi
Dardi Peter S.
Finucane Hallie A.
Isabella David J.
Patterson Thuente Skaar & Christensen P.A.
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