Leaflet engagement elements and methods for use thereof

• US 10,335,273 B2
• Filed: 01/08/2018
• Issued: 07/02/2019
• Est. Priority Date: 12/23/2003
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Salahieh, Amr, Brandt, Brian D., Geshlider, Robert A., Morejohn, Dwight P., Saul, Tom
• Primary Examiner(s): Ganesan, Suba
• Application Number:
  US15/864,343
• Publication Number:
  US 20180125652A1
• Time in Patent Office: 540 Days
• 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 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/006 modular

Abstract

The present invention relates to apparatus for methods for endovascularly replacing a patient'"'"'s heart valve. The apparatus includes an expandable anchor with leaflet engagement elements on the proximal end of the anchor and a replacement valve. The leaflet engagement elements can be used to prevent distal migration and insure proper positioning of the apparatus.

Claims

1. An apparatus for endovascularly replacing a patient'"'"'s heart valve, the apparatus comprising:

an expandable anchor supporting a replacement valve disposed within a lumen of the expandable anchor; and

a delivery catheter defining a lumen, the delivery catheter being adapted to deliver the expandable anchor and replacement valve to a vicinity of the patient'"'"'s heart valve within the lumen in a collapsed configuration;

wherein the expandable anchor and replacement valve are adapted for percutaneous delivery and deployment to replace the patient'"'"'s heart valve;

wherein the expandable anchor comprises a plurality of closed cells forming a body portion of the expandable anchor and a proximal flange portion of the expandable anchor in a deployed configuration, the proximal flange portion extending radially outward from the body portion in the deployed configuration;

wherein closed cells forming the proximal flange portion are larger than closed cells forming the body portion, wherein the expandable anchor and the replacement valve are further adapted to permit blood flow through the replacement valve and to prevent blood backflow through the replacement valve after the replacement valve exits the delivery catheter and before the proximal flange portion exits the delivery catheter,

wherein an exterior surface of the expandable anchor is covered by a seal.

2. The apparatus of claim 1, wherein the proximal flange portion is adapted to be positioned proximally of native heart valve leaflets of the patient'"'"'s heart valve in the deployed configuration.

3. The apparatus of claim 1, wherein the exterior surface of the expandable anchor, excluding the proximal flange portion, is entirely covered by the seal.

4. The apparatus of claim 1, wherein the exterior surface of the expandable anchor, including the proximal flange portion, is entirely covered by the seal.

5. The apparatus of claim 1, wherein the exterior surface of the expandable anchor covered by the seal includes the proximal flange portion.

6. The apparatus of claim 1, wherein the expandable anchor is configured to self-expand from the collapsed configuration toward the deployed configuration when unconstrained.

7. The apparatus of claim 6, wherein the expandable anchor is further configured to be actively foreshortened into the deployed configuration when disposed outside of the lumen of the delivery catheter.

8. The apparatus of claim 7, further comprising a plurality of actuation elements reversibly coupled to a proximal end of the expandable anchor.

9. The apparatus of claim 8, wherein the plurality of actuation elements is adapted to apply a distally-directed force on the proximal end of the expandable anchor.

10. The apparatus of claim 8, further comprising at least one actuation element reversibly coupled to a distal end of the expandable anchor.

11. An apparatus for endovascularly replacing a patient'"'"'s heart valve, the apparatus comprising:

an expandable anchor supporting a replacement valve disposed within a lumen of the expandable anchor; and

a delivery catheter defining a lumen, the delivery catheter being adapted to deliver the expandable anchor and replacement valve to a vicinity of the patient'"'"'s heart valve within the lumen in a collapsed configuration;

wherein the expandable anchor and replacement valve are adapted for percutaneous delivery and deployment to replace the patient'"'"'s heart valve;

wherein the expandable anchor comprises a plurality of closed cells forming a body portion of the expandable anchor and a proximal flange portion of the expandable anchor in a deployed configuration, the proximal flange portion extending radially outward from the body portion in the deployed configuration;

wherein closed cells forming the proximal flange portion are larger than closed cells forming the body portion,

further comprising a plurality of actuation elements reversibly coupled to a proximal end of the expandable anchor,

wherein the plurality of actuation elements is adapted to apply a distally-directed force on the proximal end of the expandable anchor,

wherein at least one actuation element is reversibly coupled to a distal end of the expandable anchor, and

wherein the at least one actuation element reversibly coupled to the distal end of the expandable anchor does not extend through a center opening of the replacement valve.

12. The apparatus of claim 11, wherein the proximal flange portion is adapted to be positioned proximally of native heart valve leaflets of the patient'"'"'s heart valve in the deployed configuration.

13. The apparatus of claim 11, wherein an exterior surface of the expandable anchor is covered by a seal.

14. The apparatus of claim 13, wherein the exterior surface of the expandable anchor, excluding the proximal flange portion, is entirely covered by the seal.

15. The apparatus of claim 14, wherein the expandable anchor and the replacement valve are further adapted to permit blood flow through the replacement valve and to prevent blood backflow through the replacement valve after the replacement valve exits the delivery catheter and before the proximal flange portion exits the delivery catheter.

16. The apparatus of claim 13, wherein the exterior surface of the expandable anchor, including the proximal flange portion, is entirely covered by the seal.

17. The apparatus of claim 13, wherein the exterior surface of the expandable anchor covered by the seal includes the proximal flange portion.