Prosthesis, delivery device and methods of use

• US 10,004,599 B2
• Filed: 02/20/2015
• Issued: 06/26/2018
• Est. Priority Date: 02/21/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Rabito, Glen T., Ratz, J. Brent, Pesce, Luca, Quadri, Arshad, Lam, Lindsay, Liao, Yen, Sanchez, Julio Cesar, Landon, David, Johnson, Garrett Dallas, Cooper, Alexander H.
• Primary Examiner(s): Dang, Son
• Application Number:
  US14/628,034
• Publication Number:
  US 20150238315A1
• Time in Patent Office: 1,222 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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 2230/0067 conical
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

Devices, systems and methods are described herein a prosthesis for implantation within a lumen or body cavity and delivery devices for delivering the prosthesis to a location for implantation. A delivery system can include a plurality of components which are moveable relative to each other. The delivery system can include a nose cone which can cover at least a first end of the prosthesis, an outer elongate member which can cover at least a second end of the prosthesis, and a tether which can at least partially restrain the prosthesis from deployment.

Claims

1. A delivery system for controlled deployment of a replacement mitral valve, the delivery system comprising:

a first member configured to at least partially restrain a first end of the replacement mitral valve;

a second member configured to at least partially restrain a second end of the replacement mitral valve having a plurality of anchors extending towards the first end in a deployed position;

a tether configured to at least partially encircle the replacement mitral valve at a base of the anchors and radially restrain at least a portion of the replacement mitral valve after the second member has been removed from the second end of the replacement mitral valve but with the first member still at least partially restraining the first end of the replacement mitral valve; and

a tether retention assembly configured to restrain the tether such that the tether can be tensioned to restrain at least a portion of the replacement mitral valve, the tether retention assembly comprising a C-lock.

2. The delivery system of claim 1, wherein the first member comprises a first shaft and the second member comprises a second shaft, the second shaft being positioned over the first shaft and slidable relative to the first shaft.

3. The delivery system of claim 2, wherein the first member comprises a nose cone configured to receive and cover the first end of the replacement mitral valve, the nose cone being connected to a distal end of the first shaft.

4. The delivery system of claim 3, wherein the nose cone comprises a proximally-facing opening to receive at least a first end of the replacement mitral valve.

5. The delivery system of claim 3, wherein the nose cone comprises a taper towards the distal end of the nose cone.

6. The delivery system of claim 2, wherein the first member comprises an inner retention ring configured to engage the first end of the replacement mitral valve, the inner retention ring connected to a distal portion of an inner retention shaft, the inner retention shaft being positioned between the first shaft and the second shaft and being slidable relative to the first shaft.

7. The delivery system of claim 6, wherein the inner retention ring comprises a taper towards a proximal end of the inner retention ring.

8. The delivery system of claim 6, wherein the inner retention ring comprises a cavity at or near a distal end of the inner retention ring and a compressible member received at least partially within the cavity, the compressible member having a compressed diameter and an expanded diameter.

9. The delivery system of claim 2, wherein the second member further comprises an outer elongate hollow member configured to cover at least the second end of the replacement mitral valve, the outer elongate hollow member being at a distal end of the second shaft.

10. The delivery system of claim 9, wherein the outer elongate hollow member has a substantially constant diameter throughout the entirety of its length.

11. The delivery system of claim 2, wherein the first shaft is hollow to receive a guidewire.

12. The delivery system of claim 2, further comprising a replacement mitral valve, wherein:

a first end of the replacement mitral valve engages the first member; and

a second end of the replacement mitral valve engages the second member.

13. The delivery system of claim 1, wherein the tether retention assembly comprises an inner component and an outer component, the outer component configured to cooperate with the inner component to restrain the tether.

14. The delivery system of claim 13, wherein the outer component comprises a sheath.

15. The delivery system of claim 13, wherein the outer component is moveable relative to the inner component to release the tether.

16. The delivery system of claim 13, wherein the tether retention assembly further comprises a locking shaft, the outer component positioned at or near a distal end of the locking shaft.

17. A delivery system for controlled deployment of a replacement mitral valve, the delivery system comprising:

a first member configured to at least partially restrain a first end of the replacement mitral valve;

a second member configured to at least partially restrain a second end of the replacement mitral valve having a plurality of anchors extending towards the first end in a deployed position; and

a tether configured to at least partially encircle the replacement mitral valve at a base of the anchors and radially restrain at least a portion of the replacement mitral valve after the second member has been removed from the second end of the replacement mitral valve but with the first member still at least partially restraining the first end of the replacement mitral valve;

wherein the first member comprises a first shaft and the second member comprises a second shaft, the second shaft being positioned over the first shaft and slidable relative to the first shaft;

wherein the first member comprises an inner retention ring configured to engage the first end of the replacement mitral valve, the inner retention ring connected to a distal portion of an inner retention shaft, the inner retention shaft being positioned between the first shaft and the second shaft and being slidable relative to the first shaft; and

wherein the inner retention ring comprises a cavity at or near a distal end of the inner retention ring and a compressible member received at least partially within the cavity, the compressible member having a compressed diameter and an expanded diameter.

18. A delivery system for controlled deployment of a replacement mitral valve, the delivery system comprising:

a first member configured to at least partially restrain a first end of the replacement mitral valve;

a second member configured to at least partially restrain a second end of the replacement mitral valve having a plurality of anchors extending towards the first end in a deployed position;

a tether configured to at least partially encircle the replacement mitral valve at a base of the anchors and radially restrain at least a portion of the replacement mitral valve after the second member has been removed from the second end of the replacement mitral valve but with the first member still at least partially restraining the first end of the replacement mitral valve; and

a tether retention assembly configured to restrain the tether such that the tether can be tensioned to restrain at least a portion of the replacement mitral valve;

wherein the first member comprises a first shaft and the second member comprises a second shaft, the second shaft being positioned over the first shaft and slidable relative to the first shaft;

wherein the tether retention assembly comprises an inner component and an outer component, the outer component configured to cooperate with the inner component to restrain the tether; and

wherein the outer component is moveable relative to the inner component to release the tether.