Prosthetic cardiac value and method for making same

• US 7,377,938 B2
• Filed: 06/29/2004
• Issued: 05/27/2008
• Est. Priority Date: 07/19/2001
• Status: Expired due to Fees

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Sarac, Timur Paul, Smedira, Nicholas G.
• Primary Examiner(s): Stewart; Alvin J.
• Application Number:
  US10/880,277
• Publication Number:
  US 20040236411A1
• Time in Patent Office: 1,428 Days
• Field of Search: 623 124- 126, 623 211- 212, 623/2.14, 623/2.18
• US Class Current: 623/1.26
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3645 Connective tissue
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: Y10S 623/915 Method or apparatus for preparing biological material

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.

Claims

1. A prosthetic valve for replacing a cardiac valve, said prosthetic valve comprising:

an expandable support member comprising a 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;

said stent having oppositely disposed proximal and distal end sections and a center section disposed between said end sections, said at least two valve leaflets extending within said center section;

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 being attached to said inner surface;

said second layer including a radially inwardly facing surface that defines a conduit for directing blood flow;

said at least two valve leaflets extending across said conduit to permit unidirectional flow of blood through said conduit; and

wherein said center section of said stent has a convex shape in the axial direction for conforming to the shape of the cardiac wall downstream of the cardiac valve.

2. The prosthetic valve of claim 1 wherein said distal end section of said stent has a concave shape in the axial direction for conforming to the shape of the cardiac wall downstream of the cardiac valve.

3. A prosthetic valve for replacing a cardiac valve, said prosthetic valve comprising:

an expandable support member comprising a 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;

said stent having oppositely disposed proximal and distal end sections and a center section disposed between said end sections, said at least two valve leaflets extending within said center section;

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 being attached to said inner surface;

said second layer including a radially inwardly facing surface that defines a conduit for directing blood flow;

said at least two valve leaflets extending across said conduit to permit unidirectional flow of blood through said conduit; and

wherein at least one of said proximal, distal, and center sections of said stent is balloon-expanded;

at least one of said proximal, distal, and center sections of said stent is self-expanding; and

said proximal section of said stent is balloon-expanded and said distal and center sections are self-expanding.

4. A prosthetic valve for replacing an aortic valve, said prosthetic valve comprising:

an expandable stent having inner and outer surfaces, said stent having oppositely disposed proximal and distal end sections and a center section disposed between said end sections;

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, said at least two valve leaflets extending within said center section;

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;

said at least two valve leaflets extending across said conduit to permit unidirectional flow of blood through said conduit; and

wherein said center section of said stent has a convex shape in the axial direction for conforming to the shape of the cardiac wall downstream of the aortic valve.

5. The prosthetic valve of claim 4 wherein said distal end section of said stent has a concave shape in the axial direction for conforming to the shape of the cardiac wall downstream of the aortic valve.

6. A prosthetic valve for replacing an aortic valve, said prosthetic valve comprising:

an expandable stent having inner and outer surfaces, said stent having oppositely disposed proximal and distal end sections and a center section disposed between said end sections;

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, said at least two valve leaflets extending within said center section;

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;

said at least two valve leaflets extending across said conduit to permit unidirectional flow of blood through said conduit; and

wherein at least one of said proximal, distal, and center sections of said stent is balloon-expanded;

at least one of said proximal, distal, and center sections of said stent is self -expanding; and

said proximal section of said stent is balloon-expanded and said distal and center sections are self-expanding.