Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Including valve
Patent
1999-06-10
2000-10-03
Willse, David H.
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Including valve
623910, 623918, 623925, 623 126, 623 213, A61F 206
Patent
active
061266868
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates to a tissue graft composition and method for its preparation and use. More particularly, the present invention is directed to non-immunogenic submucosal tissue graft compositions prepared from warm-blooded vertebrates and formed into vascular valves. The artificial vascular valves of the present invention are useful for replacing damaged or diseased valves of a warm-blooded vertebrate.
BACKGROUND AND SUMMARY OF THE INVENTION
There are four valves in the heart that direct the flow of blood through the two sides of the heart and out to the various organs of the body. The valves located on the left (systemic) side of the heart are: 1) the mitral valve, located between the left atrium and the left ventricle, and 2) the aortic valve, located between the left ventricle and the aorta. These two valves direct oxygenated blood coming from the lungs, through the left side of the heart and into the aorta for distribution to the body. On the right (pulmonary) side of the heart are: 1) the tricuspid valve, located between the right atrium and the right ventricle, and 2) the pulmonary valve, located between the right ventricle and the pulmonary artery. These two valves direct deoxygenated blood coming from the body, through the right side of the heart, into the pulmonary artery for distribution to the lungs, where it again becomes re-oxygenated to begin the circuit anew.
All four of these heart valves are passive structures in that they do not themselves expend any energy and do not perform any active contractile function. They consist of movable "leaflets" that are designed to open and close in response to differential pressures on either side of the valve. The mitral and tricuspid valves are referred to as "atrioventricular valves" because they are located between an atrium and a ventricle of the heart. The mitral valve has two leaflets whereas the tricuspid valve has three leaflets. The aortic and pulmonary valves each have three leaflets, which are more aptly termed "cusps".
Over 150,000 surgical procedures are performed each year to replace diseased cardiac valves worldwide. Two out of three procedures currently employ mechanical valve prostheses. Mechanical valves include caged-ball valves (such as Starr-Edwards valves), bi-leaflet valves (such as St. Jude valves), and titling disk valves (such as Medtronic-Hall or Omniscience valves). Caged ball valves typically comprise a ball made of a silicone rubber located inside a titanium cage, while bi-leaflet and tilting disk valves are made of various combinations of pyrolytic carbon and titanium. All of these valves have a cloth (usually Dacron.TM.) sewing ring so that the valve prosthesis can be sutured to the patient's native tissue to secure the implanted artificial valve.
The main advantage of mechanical valves is their long-term durability. However, currently available mechanical valves suffer from the disadvantage that they are thrombogenic and thus the patient requires lifetime anticoagulant therapy. If blood clots form on the valve, they may preclude the valve from opening or closing correctly or, more importantly, the blood clots may disengage from the valve and embolize to the brain, causing a stroke. Anticoagulant drugs can be administered to reduce the risk of blood clot formation, however such drugs are expensive and potentially dangerous in that they may cause abnormal bleeding which, in itself, can cause a stroke if the bleeding occurs within the brain.
One alternative to mechanical valves are valves constructed from natural tissues. Artificial valves constructed from natural tissues have superior hemodynamic characteristics, and accordingly the clinical use of tissue-based valves is growing faster than the overall valvular prosthesis market. Currently available tissue valves are constructed either by sewing the leaflets of pig aortic valves to a stent (to hold the leaflets in proper position), or by constructing valve leaflets from the pericardial sac (which surrounds the heart) of cows or pigs an
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Love. Autologous Tissue Heart Valves. R. G. Landes Company, 1993, pp. 1-22.
Badylak Stephen F.
Coffey Arthur C.
Geddes Leslie A.
Hiles Michael C.
Hong James
Pellegrino Brian
Purdue Research Foundation
Willse David H.
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