Methods and Apparatus for Endovascular Heart Valve Replacement Comprising Tissue Grasping Elements

• US 20140243967A1
• Filed: 05/01/2014
• Published: 08/28/2014
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Salahieh, Amr, Hildebrand, Daniel K., Saul, Tom
• Granted Patent: US 10,314,695 B2
• Time in Patent Office: Days
• US Class Current: 623/2.19
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

The present invention provides an apparatus for endovascularly replacing a patient'"'"'s heart valve. In some embodiments, the apparatus includes an expandable anchor supporting a replacement valve, the anchor and replacement valve being adapted for percutaneous delivery and deployment to replace the patient'"'"'s heart valve, the anchor having a braid having atraumatic grasping elements adapted to grasp tissue in a vicinity of the patient'"'"'s heart valve.

Claims

1. A replacement heart valve comprising:

an expandable anchor comprising a radially expandable metallic framework, the framework defined by a plurality of interconnected circumferential undulating bands having peaks and valleys forming a closed cell configuration, the expandable anchor comprising a delivery configuration, an at-rest configuration, and a deployed configuration, the expandable anchor comprising three vertical posts equidistantly spaced about the circumference of the anchor and attached to the expandable metallic framework; and

a tri-leaflet valve, the tri-leaflet valve disposed within the expandable anchor and coupled to the posts.

2. The replacement heart valve of claim 1 wherein the at-rest configuration has a diameter larger than a diameter of the delivery configuration and smaller than a diameter of the deployed configuration.

3. The replacement heart valve of claim 1 wherein the expandable anchor comprises a braid.

4. The replacement heart valve of claim 3 wherein the expandable anchor comprises a proximal end and a distal end, said braid comprises a closed end at least at the proximal end of the expandable anchor.

5. The replacement heart valve of claim 4 wherein the braid comprises a closed end at both the proximal end and the distal end of the expandable anchor.

6. The replacement heart valve of claim 1 wherein said tri-leaflet valve is coupled to the expandable anchor at posts attached at a distal region of the anchor.

7. The replacement heart valve of claim 3 wherein the posts are attached to the braid of the expandable anchor.

8. The replacement heart valve of claim 7 wherein the posts are attached to a distal region of the braid of the expandable anchor, a central region of the braid of the expandable anchor, a proximal region of the braid of the expandable anchor, or a combination thereof.

9. The replacement heart valve of claim 1 wherein the tri-leaflet valve comprises metal, synthetic material or is derived from animal tissue.

10. The replacement valve of claim 1 wherein the tri-leaflet valve is secured within the expandable anchor.

11. The replacement heart valve of claim 1 wherein the posts comprise a two-part locking mechanism and the anchor comprises buckles, the two-part locking mechanism and the buckles are actuatable.

12. The replacement heart valve of claim 11 wherein said two-part locking mechanism is selectively reversible after an actuation of the two-part locking mechanism and buckles.

13. The replacement heart valve of claim 1 wherein the anchor is self-expanding.

14. The replacement heart valve of claim 1 wherein the anchor is actively expanding.

15. The replacement heart valve of claim 13 wherein the anchor comprises a shape memory material.

16. The replacement heart valve of claim 15 wherein the anchor comprises cobalt-chromium steel.

17. The replacement heart valve of claim 14 wherein the anchor comprises stainless steel.

18. The replacement heart valve of claim 1 wherein the expandable anchor comprises a braid, the expandable anchor comprises a distal end and a proximal end, at least one of the distal end and the proximal comprises closed end turns.

19. The replacement heart valve of claim 18 wherein the distal end and the proximal end of the expandable anchor comprise closed end turns.

20. The replacement heart valve of claim 18 wherein the expandable anchor comprises closed end turns of a substantially uniform cell size and shape.