Prosthetic cardiac valve and method for making same
First Claim
1. A prosthetic valve for replacing a cardiac valve, said prosthetic valve comprising:
- an expandable support member;
at least two valve leaflets made of a first layer of biological material selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue;
a second layer of biological material attached to said support member, said second layer being selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue;
said second layer including a radially inwardly facing surface that defines a conduit for directing blood flow; and
said at least two valve leaflets extending across said conduit to permit unidirectional flow of blood through said conduit.
1 Assignment
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Accused Products
Abstract
A prosthetic valve for replacing a cardiac valve includes an expandable support member and at least two valve leaflets made of a first layer of biological material selected from peritoneal tissue, pleural tissue or pericardial tissue. A second layer of biological material is attached to the support member. The second layer is also made from peritoneal tissue, pleural tissue or pericardial tissue. The second layer includes a radially inwardly facing surface that defines a conduit for directing blood flow. The valve leaflets extend across the conduit to permit unidirectional flow of blood through the conduit. Methods for making and implanting the prosthetic valve are also provided.
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Citations
68 Claims
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1. A prosthetic valve for replacing a cardiac valve, said prosthetic valve comprising:
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an expandable support member;
at least two valve leaflets made of a first layer of biological material selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue;
a second layer of biological material attached to said support member, said second layer being selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue;
said second layer including a radially inwardly facing surface that defines a conduit for directing blood flow; and
said at least two valve leaflets extending across said conduit to permit unidirectional flow of blood through said conduit. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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24. A prosthetic valve for replacing an aortic valve, said prosthetic valve comprising:
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an expandable stent having inner and outer surfaces;
at least two valve leaflets made of a first layer of biological material selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue;
a second layer of biological material attached to said inner surface of said stent, said second layer being selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue;
said second layer including a radially inwardly facing surface that defines a conduit for directing blood flow; and
said at least two valve leaflets extending across said conduit to permit unidirectional flow of blood through said conduit. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45)
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46. A method for producing a prosthetic valve, said method comprising the steps of:
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harvesting a first layer of biological material comprising a single sheet of material selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue;
trimming the sheet of biological material to form at least two valve leaflets, each of the at least two valve leaflets having an oppositely disposed pair of lateral sides spaced apart by a free edge;
placing the lateral sides of each of the at least two valve leaflets adjacent each other and attaching them to each other to form an oppositely disposed pair of commissural sides separated by the free edges that are coaptable to permit unidirectional flow of blood;
attaching support means to the sheet of biological material to provide structural support for the at least two valve leaflets, the support means comprising an expandable stent;
harvesting a second layer of biological material selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue; and
attaching the second layer of biological material to an inner surface of the stent. - View Dependent Claims (47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59)
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60. A method for replacing a cardiac valve with a prosthetic valve, said method comprising the steps of:
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harvesting a first layer of biological material comprising a single sheet of material selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue;
trimming the sheet of biological material to form at least two valve leaflets, each of the at least two valve leaflets having an oppositely disposed pair of lateral sides spaced apart by a free edge;
placing the lateral sides of each of the at least two valve leaflets adjacent each other and attaching them to each other to form an oppositely disposed pair of commissural sides separated by the free edges that are coaptable to permit unidirectional flow of blood;
attaching support means to the sheet of biological material to provide structural support for the at least two valve leaflets, the support means comprising an expandable stent having oppositely disposed proximal and distal end sections and a center section disposed between the end sections, the at least two valve leaflets being attached to the center section of the stent;
harvesting a second layer of biological material selected from a group consisting of peritoneal tissue, pleural tissue and pericardial tissue;
attaching the second layer of biological material to an inner surface of the stent to complete the process of forming the prosthetic valve;
collapsing the stent of the prosthetic valve to a radially compressed condition;
inserting the prosthetic valve into the heart to the annulus of the cardiac valve in the compressed condition; and
expanding the stent of the prosthetic valve into engagement with the annulus. - View Dependent Claims (61, 62, 63, 64, 65, 66, 67, 68)
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Specification