Methods and apparatus for endovascular heart valve replacement comprising tissue grasping elements

• US 10,314,695 B2
• Filed: 05/01/2014
• Issued: 06/11/2019
• Est. Priority Date: 12/23/2003
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Salahieh, Amr, Hildebrand, Daniel K., Saul, Tom
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): Preston, Rebecca S
• Application Number:
  US14/267,498
• Publication Number:
  US 20140243967A1
• Time in Patent Office: 1,867 Days
• 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 apparatus comprising:

an expandable anchor comprising a radially expandable metallic framework forming closed cells, the expandable anchor comprising a delivery configuration, an at-rest configuration, and a deployed configuration; and

a replacement heart valve disposed within and coupled to the expandable anchor;

wherein the expandable anchor self-expands from the delivery configuration to the at-rest configuration upon removal from a delivery sheath;

wherein the expandable anchor requires active foreshortening by application of an axially-directed force to the expandable anchor to shift from the at-rest configuration to the deployed configuration;

wherein the expandable anchor comprises a braid.

2. The replacement heart valve apparatus 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 apparatus of claim 1 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.

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

5. The replacement heart valve apparatus of claim 1 wherein the replacement heart valve comprises metal, synthetic material or is derived from animal tissue.

6. The replacement heart valve apparatus of claim 1 wherein the anchor comprises a shape memory material.

7. The replacement heart valve apparatus of claim 6 wherein the anchor comprises cobalt-chromium steel.

8. The replacement heart valve apparatus of claim 1 wherein the anchor comprises stainless steel.

9. A replacement heart valve apparatus comprising:

an expandable anchor comprising a radially expandable metallic framework forming closed cells, the expandable anchor comprising a delivery configuration, an at-rest configuration, and a deployed configuration;

a replacement heart valve disposed within and coupled to the expandable anchor;

wherein the expandable anchor self-expands from the delivery configuration to the at-rest configuration upon removal from a delivery sheath;

wherein the expandable anchor requires active foreshortening by application of an axially-directed force to the expandable anchor to shift from the at-rest configuration to the deployed configuration; and

a two-part locking mechanism, wherein the replacement heart valve is supported by posts and the anchor comprises buckles, wherein the posts and the buckles are configured to engage each other in the deployed configuration.

10. The replacement heart valve apparatus of claim 9 wherein said two-part locking mechanism is selectively reversible after engagement of the posts and buckles.

11. The replacement heart valve apparatus of claim 9 wherein the posts are attached to the expandable anchor.

12. The replacement heart valve apparatus of claim 11 wherein the posts are attached to a distal region of the expandable anchor, a central region of the expandable anchor, a proximal region of the expandable anchor, or a combination thereof.

13. A replacement heart valve apparatus comprising:

an expandable anchor comprising a radially expandable metallic framework forming closed cells, the expandable anchor comprising a delivery configuration, an at-rest configuration, and a deployed configuration; and

a replacement heart valve disposed within and coupled to the expandable anchor;

wherein the expandable anchor self-expands from the delivery configuration to the at-rest configuration upon removal from a delivery sheath;

wherein the expandable anchor requires active foreshortening by application of an axially-directed force to the expandable anchor to shift from the at-rest configuration to the deployed configuration;

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 end comprises closed end turns.

14. The replacement heart valve apparatus of claim 13 wherein the distal end and the proximal end of the expandable anchor comprise closed end turns.

15. The replacement heart valve apparatus of claim 13 wherein the expandable anchor comprises closed end turns forming cells of a substantially uniform cell size and shape.