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

• US 10,258,465 B2
• Filed: 10/03/2016
• Issued: 04/16/2019
• Est. Priority Date: 12/23/2003
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Salahieh, Amr, Hildebrand, Daniel K., Saul, Tom
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): Preston, Rebecca
• Application Number:
  US15/283,867
• Publication Number:
  US 20170112621A1
• Time in Patent Office: 925 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 2/243 Deployment by mechanical expansion
• 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 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/885 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2210/0057 stretchable
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2220/0083 using hook and loop-type fasteners
• 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 2250/0017 differing in yarn density
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/0048 : differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/006 : modular
• CPC Class Codes: A61F 2250/0069 : Sealing means

Abstract

A method for endovascularly replacing a patient'"'"'s heart valve including the following steps: endovascularly delivering an anchor and a replacement valve supported within the anchor to a vicinity of the heart valve in a collapsed delivery configuration, the anchor having grasping elements adapted to grasp tissue in a vicinity of the heart valve; expanding the anchor, thereby rotating the grasping elements; and grasping the tissue with the rotating grasping elements.

Claims

1. A method for endovascularly replacing a patient'"'"'s native heart valve, the method comprising:

delivering a radially expandable anchor and a replacement valve supported within the anchor to a vicinity of the native heart valve, wherein the anchor defines a plurality of cells having a tubular shape extending from a downstream end of the plurality of cells to an upstream end of the plurality of cells, the anchor including leaflet engagement elements attached at the downstream end of the plurality of cells and extending distally therefrom;

sandwiching native valve leaflets between the distally extending leaflet engagement elements and the plurality of cells; and

radially expanding the anchor to a fully deployed configuration to secure the anchor within the native heart valve;

wherein the replacement valve allows the flow of blood downstream through the replacement valve in a first configuration and prevents the flow of blood through the replacement valve in a second configuration.

2. The method of claim 1, wherein the native valve leaflets are sandwiched between a downstream region of the plurality of cells and the leaflet engagement elements in the fully deployed configuration.

3. The method of claim 1, wherein the leaflet engagement elements are formed from arcuate wires attached to the plurality of cells at opposing ends of the arcuate wires.

4. The method of claim 3, wherein the opposing ends of the arcuate wires are circumferentially spaced apart around the plurality of cells.

5. The method of claim 1, wherein adjacent leaflet engagement elements are free from circumferential overlap with each other.

6. The method of claim 1, wherein adjacent leaflet engagement elements partially circumferentially overlap each other.

7. The method of claim 1, wherein the anchor further includes a seal extending downstream over the plurality of cells from the upstream end of the plurality of cells.

8. The method of claim 1, wherein the anchor is self-expandable from a delivery configuration to an at-rest configuration.

9. The method of claim 8, wherein the anchor requires active foreshortening to shift from the at-rest configuration to the fully deployed configuration.

10. A method for endovascularly replacing a patient'"'"'s native heart valve, the method comprising:

delivering a radially expandable anchor and a replacement heart valve supported within the anchor to a vicinity of the native heart valve;

wherein the anchor defines a tubular structure extending from a downstream end to an upstream end, the anchor including leaflet engagement elements attached at the downstream end of the tubular structure and extending distally therefrom;

deploying the leaflet engagement elements adjacent native valve leaflets, downstream of the native valve leaflets;

advancing the anchor and leaflet engagement elements upstream to sandwich the native valve leaflets between the leaflet engagement elements and an outer surface of the tubular structure downstream of an annulus of the native heart valve; and

radially expanding the anchor to a fully deployed configuration to secure the anchor within the native heart valve;

wherein the replacement heart valve allows the flow of blood downstream through the replacement heart valve in a first configuration and prevents the flow of blood through the replacement heart valve in a second configuration.

11. The method of claim 10, wherein the native valve leaflets are sandwiched against the outer surface of the tubular structure in the fully deployed configuration.

12. The method of claim 10, wherein the leaflet engagement elements are formed from arcuate wires having a first end directly attached to the tubular structure at the downstream end and a second opposing end directly attached to the tubular structure at the downstream end.

13. The method of claim 12, wherein the first and second ends of the arcuate wires are circumferentially spaced apart around the downstream end of the tubular structure.

14. The method of claim 10, wherein adjacent leaflet engagement elements are free from circumferential overlap with each other.

15. The method of claim 10, wherein adjacent leaflet engagement elements partially circumferentially overlap each other.

16. The method of claim 10, wherein the anchor further includes a seal extending downstream over the tubular structure from the upstream end of the tubular structure.

17. The method of claim 10, wherein the anchor is self-expandable from a delivery configuration to an at-rest configuration.

18. The method of claim 17, wherein the anchor requires active foreshortening to shift from the at-rest configuration to the fully deployed configuration.