Valve apparatus, system and method

• US 8,512,399 B2
• Filed: 12/28/2009
• Issued: 08/20/2013
• Est. Priority Date: 04/15/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Lafontaine, Daniel M.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US12/648,221
• Publication Number:
  US 20100100173A1
• Time in Patent Office: 1,331 Days
• Field of Search: 623/2.11, 623/2.12, 623/2.14, 623/2.17, 623/2.18, 623/2.38, 623/1.24
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A cardiac valve with a first anchor frame and a cover on the first anchor frame for unidirectional flow of a liquid through the valve.

Claims

1. A cardiac valve prosthesis, comprising:

only a first anchor frame consisting of a first single frame member that forms a ring around a common axis, where an infinitely vast plane parallel with and passing through the common axis and extending beyond an overall width and an overall height of the single frame member can only pass through two portions of the first single frame member to define a cross-sectional profile for each of the two portions having only one contiguous edge, and where the first single frame member has an inner portion defining an opening through the first anchor frame and an upper portion generally orthogonal to the inner portion;

two or more leaflets coupled to the first anchor frame; and

a pair of anchor members vertically extending from an apex of the first single frame member, the pair of anchor members restrained under tension in a first predetermined shape with a deployment member passing between the pair of anchor members, where the pair of anchor members moves toward a second predetermined shape when the deployment member is removed from between the pair of anchor members.

2. The cardiac valve of claim 1, wherein the pair of anchor members extend parallel with the common axis that is perpendicular to a common plane extending through the first anchor frame.

3. The cardiac valve of claim 1, wherein the pair of anchor members extend at an acute angle relative a common plane extending through the first anchor frame.

4. The cardiac valve of claim 1, wherein the first anchor frame expands from a first predetermined configuration to a fully deployed configuration.

5. The cardiac valve of claim 1, including a sealing material on the first anchor frame to prevent leakage of a liquid outside of the opening after anchoring the cardiac valve to tissue.

6. The cardiac valve of claim 5, wherein the sealing material expands in volume upon contacting the liquid.

7. The cardiac valve of claim 1, includes a sealing material positioned between the first anchor frame and deployment member, where upon removing the deployment member and anchoring the cardiac valve to tissue the sealing material prevents leakage of a liquid outside of the cardiac valve.

8. A cardiac valve prosthesis, comprising:

a first anchor frame having first single contiguous frame member that forms a ring around a common axis and has an inner portion defining an opening through the first anchor frame and an upper portion generally orthogonal to the inner portion, the first anchor frame having a plurality of apexes;

two of more leaflets coupled to the first anchor frame; and

two or more anchor members on each apex of the first single contiguous frame member, the two or more anchor members restrained under tension in a first predetermined shape with a deployment member passing between the two of more anchor members, where the two or more anchor members move towards a second predetermined shape when the deployment member is removed from between the two or more anchor members.

9. The cardiac valve prosthesis of claim 8, wherein the one or more anchor members extend parallel with the common axis.

10. The cardiac valve prosthesis of claim 8, wherein the one or more anchor members extend at an acute angle relative a common plane extending through the first anchor frame.

11. The cardiac valve prosthesis of claim 8, wherein the first anchor frame expands from a first predetermined configuration to a fully deployed configuration.

12. The cardiac valve prosthesis of claim 8, including a sealing material on the first anchor frame that prevents leakage of a liquid outside of the opening after anchoring the cardiac valve to tissue.

13. The cardiac valve prosthesis of claim 8, including a sealing material positioned between the first anchor frame and the deployment member, where upon removing the deployment member and anchoring the cardiac valve to tissue the sealing material prevents leakage of liquid outside of the opening of the cardiac valve.