Methods and apparatus for endovascularly replacing a patient's heart valve

• US 10,357,359 B2
• Filed: 12/15/2016
• Issued: 07/23/2019
• 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: Haug, Ulrich R., Valencia, Hans F., Geshlider, Robert A., Saul, Tom, Salahieh, Amr, Morejohn, Dwight P.
• Primary Examiner(s): Matthews, William H
• Application Number:
  US15/380,135
• Publication Number:
  US 20170189176A1
• Time in Patent Office: 950 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

The present invention provides methods and apparatus for endovascularly replacing a patient'"'"'s heart valve. The apparatus includes a replacement valve and an anchor having an expandable braid. In some embodiments, the expandable braid is fabricated from a single strand of wire. In some embodiments, the expandable braid comprises at least one turn feature. The anchor and the valve preferably are configured for endovascular delivery and deployment.

Claims

1. An apparatus for endovascularly replacing a heart valve, comprising:

a delivery system comprising an outer sheath and a control handle coupled to a proximal end of the outer sheath; and

a replacement heart valve implant comprising;

an expandable anchor having a central longitudinal axis, a delivery configuration and a deployed configuration; and

a replacement valve coupled to the expandable anchor;

wherein the expandable anchor includes a plurality of edge cells attached at their respective distal ends to a proximal circumference of the expandable anchor, the plurality of edge cells being inwardly canted toward the central longitudinal axis in the deployed configuration with the proximal extent of each edge cell of the plurality of edge cells being located radially inward of the distal end thereof.

2. The apparatus of claim 1, wherein a proximal portion of the expandable anchor forms a conical profile in the deployed configuration.

3. The apparatus of claim 1, wherein the delivery system includes a plurality of fingers engaged with a proximal portion of the expandable anchor.

4. The apparatus of claim 1, wherein the replacement heart valve implant is disposed within a distal end of the outer sheath in the delivery configuration.

5. The apparatus of claim 4, wherein the expandable anchor is configured to radially expand from the delivery configuration to the deployed configuration after the outer sheath is removed from an exterior of the replacement heart valve implant.

6. The apparatus of claim 1, wherein the replacement valve includes a plurality of valve leaflets.

7. The apparatus of claim 1, wherein an overall length of the expandable anchor axially shortens as the expandable anchor is expanded from the delivery configuration to the deployed configuration.

8. An apparatus for endovascularly replacing a heart valve, comprising:

a delivery system comprising an outer sheath and a control handle coupled to a proximal end of the outer sheath; and

a replacement heart valve implant comprising;

an expandable anchor having a central longitudinal axis, a plurality of proximal edge cells attached at their respective distal ends to the proximal circumference of the expandable anchor, a delivery configuration and a deployed configuration; and

a replacement valve coupled to the expandable anchor;

wherein the expandable anchor in the deployed configuration includes a proximal edge cell configuration having an initial outward cant in a proximal direction from a body portion of the expandable anchor and an inward cant proximal of the initial outward cant with the proximal extent of each edge cell of the plurality of proximal edge cells being located radially inward of the distal end thereof.

9. The apparatus of claim 8, wherein the inward cant provides a proximal circumference of the expandable anchor with a conical configuration in the deployed configuration.

10. The apparatus of claim 8, wherein the initial outward cant is configured to engage native leaflets of the heart valve in the deployed configuration.

11. The apparatus of claim 8, wherein the delivery system includes a plurality of fingers engaged with a proximal portion of the expandable anchor.

12. The apparatus of claim 8, wherein the replacement heart valve implant is disposed within a distal end of the outer sheath in the delivery configuration.

13. The apparatus of claim 12, wherein the expandable anchor is configured to radially expand from the delivery configuration to the deployed configuration after the outer sheath is removed from an exterior of the replacement heart valve implant.

14. The apparatus of claim 8, wherein the replacement valve includes a plurality of valve leaflets.

15. The apparatus of claim 8, wherein an overall length of the expandable anchor axially shortens as the expandable anchor is expanded from the delivery configuration to the deployed configuration.