Body cavity prosthesis

• US 9,339,377 B2
• Filed: 03/05/2013
• Issued: 05/17/2016
• Est. Priority Date: 09/29/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Quadri, Arshad, Ratz, J. Brent
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US13/786,083
• Publication Number:
  US 20130184813A1
• Time in Patent Office: 1,169 Days
• Field of Search: 623/1.24, 623/1.36, 623/2.17, 623/2.4, 623/2.14
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: Y10T 29/49426 including metal shaping and diverse operation

Abstract

A prosthesis can be configured to be deployed within a body cavity. The prosthesis has an expandable frame, a plurality of proximal anchors, and a plurality of distal anchors, where the various anchors are connected to the frame. Radial expansion of the frame can cause the ends of the proximal anchors and the ends of the distal anchors to draw closer together.

Claims

1. A prosthesis configured to be deployed within a patient'"'"'s mitral valve having a mitral annulus, the prosthesis comprising:

an expandable frame comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the frame configured to radially expand and collapse for deployment within the mitral valve;

a plurality of proximal anchors each connected to the frame so that when the frame is in an expanded configuration, outermost ends of the proximal anchors are positioned radially outward from the frame and configured to be positioned on an atrial side of the mitral annulus; and

a plurality of distal anchors each connected to the frame so that when the frame is in an expanded configuration, the distal anchors curve radially outwardly and have outermost ends that are positioned radially outward from the frame and extend generally proximally so that the outermost ends of the distal anchors are proximal to where the distal anchors connect to the frame, the plurality of distal anchors each comprising a tip that extends proximally and substantially parallel to the longitudinal axis of the frame when the frame is in an expanded configuration, the distal anchors configured to be positioned on a ventricular side of the mitral annulus;

a valve body attached to the frame, wherein the valve body can move between (i) an open position wherein blood can flow from the proximal end toward the distal end to allow blood to flow from the left atrium to the left ventricle, and (ii) a closed position which blocks blood from flowing from the distal end toward the proximal end to block blood from flowing from the left ventricle to the left atrium;

wherein the outermost ends of the proximal anchors are circumferentially offset from the outermost ends of the distal anchors when the frame is in an expanded configuration; and

wherein the frame is configured such that radial expansion of the frame causes the proximal anchors and the distal anchors to draw closer together.

2. The prosthesis of claim 1, wherein the proximal anchors extend radially outwardly from the frame and comprise tips that extends distally when the frame is in an expanded configuration.

3. The prosthesis of claim 1, wherein the proximal anchors comprise protuberances extending from free apices of adjacent struts.

4. The prosthesis of claim 1, wherein the frame comprises a foreshortening portion.

5. The prosthesis of claim 4, wherein the distal anchors are connected to the foreshortening portion.

6. The prosthesis of claim 5, wherein the proximal anchors are connected to the foreshortening portion.

7. The prosthesis of claim 5, wherein the frame comprises a non-foreshortening portion and the proximal anchors are connected to the non-foreshortening portion.

8. The prosthesis of claim 1, wherein the frame comprises a material capable of self-expansion.

9. The prosthesis of claim 1, wherein the distal anchors are covered with a fabric portion to prevent direct engagement of the distal anchors with tissue.

22. The prosthesis of claim 1, wherein the proximal anchors extend generally distally so that the outermost ends of the proximal anchors are distal to where the proximal anchors connect to the frame.

23. The prosthesis of claim 1, wherein the proximal anchors extend longitudinally in a generally distal direction.

24. The prosthesis of claim 1, wherein each of the proximal anchors comprises at least a first strut and a second strut joined together to form a V-shape.

25. The prosthesis of claim 1, wherein each of the proximal anchors is connected to struts of the frame that have at least a portion thereof extending longitudinally.

26. The prosthesis of claim 1, wherein the distal anchors extend longitudinally in a generally proximal direction.

10. A prosthesis configured to be deployed within a body cavity, the prosthesis comprising:

an expandable frame comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the frame configured to radially expand and contract for deployment within the body cavity, wherein the frame comprises a foreshortening portion and a non-foreshortening portion, wherein;

the foreshortening portion comprises a plurality of interconnected cells having a proximal end and a distal end; and

the non-foreshortening portion comprising a plurality of struts having at least a portion thereof extending longitudinally so that the non-foreshortening portion is not substantially expandable in a longitudinal direction, the struts having distal ends that are connected to the proximal ends of the cells, wherein the portion of each of the struts that extends longitudinally extends only longitudinally for substantially the entire distance between the proximal ends of the cells and the proximal end of the frame;

a plurality of proximal anchors each connected to the non-foreshortening portion of the frame so that when the frame is in an expanded configuration, outermost portions of the proximal anchors are positioned radially outward from the frame; and

a plurality of distal anchors each connected to the foreshortening portion of the frame so that when the frame is in an expanded configuration, outermost portions of the distal anchors are positioned radially outward from the frame and extend proximally and substantially parallel to the longitudinal axis of the frame when the frame is in an expanded configuration;

wherein the frame is configured such that radial expansion of the frame causes the proximal anchors and the distal anchors to draw closer together.

11. The prosthesis of claim 10, wherein the foreshortening portion is located in a distal portion of the frame and the non-foreshortening portion is located at least in a proximal portion of the frame.

12. The prosthesis of claim 10, wherein when the frame is in an expanded configuration, the proximal anchors extend radially outwardly from the frame and comprise tips that extend distally, and the distal anchors extend radially outwardly from the frame and comprise tips that extend proximally.

13. The prosthesis of claim 10, wherein the proximal anchors comprise protuberances extending from free apices of adjacent struts.

14. The prosthesis of claim 10, wherein the frame comprises a material capable of self-expansion.

15. The prosthesis of claim 10, further comprising a valve body attached to the frame.

16. The prosthesis of claim 10, wherein the non-foreshortening portion comprises at least one row of circumferentially expansible elements, and wherein the struts extend transversely across the at least one row.

17. The prosthesis of claim 10, wherein the struts extend longitudinally over a length that is greater than the length of at least one cell.

18. The prosthesis of claim 10, wherein for each of the plurality of struts, the portion that extends longitudinally and the longitudinal axis both lie entirely within a common plane.

19. The prosthesis of claim 10, wherein the proximal anchors are connected to the non-foreshortening portion of the frame at a junction between the non-foreshortening portion and the foreshortening portion.

20. The prosthesis of claim 10, wherein the proximal anchors are connected to the non-foreshortening portion of the frame at a location on the struts proximally spaced from a junction between the non-foreshortening portion and the foreshortening portion.

21. The prosthesis of claim 10, wherein each of the proximal anchors comprises at least a first strut and a second strut joined together to form a V-shape.