PROSTHESIS, DELIVERY DEVICE AND METHODS OF USE

• US 20150238315A1
• Filed: 02/20/2015
• Published: 08/27/2015
• Est. Priority Date: 02/21/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Cardiaq Valve Technologies Incorporated
• Inventors: Rabito, Glen, Ratz, J. Brent, Pesce, Luca, Quadri, Arshad, Lam, Lindsay, Liao, Yen, Johnson, Garrett, Sanchez, Julio Cesar, Landon, David, Cooper, Alexander H.
• Granted Patent: US 10,004,599 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 valve, the delivery system comprising:

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

a second member configured to at least partially restrain a second end of the replacement valve; and

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

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 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 valve.

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

8. The delivery system of claim 2, wherein the first member comprises an inner retention ring configured to engage the first end of the replacement 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.

9. The delivery system of claim 8, wherein the inner retention ring comprises a taper towards a proximal end of the inner retention ring.

10. The delivery system of claim 8, 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.

11. The delivery system of claim 2, further comprising 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 valve.

12. The delivery system of claim 11, 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.

13. The delivery system of claim 12, wherein the inner component comprises a C-lock.

14. The delivery system of claim 12, wherein the outer component comprises a sheath.

15. The delivery system of claim 12, wherein the outer component is moveable relative to the inner component to release the tether.

16. The delivery system of claim 12, wherein the tether retention assembly further comprises a locking shaft, the outer component positioned at or near a distal end of the locking shaft.

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

20. The delivery system of claim 19, wherein the outer elongate hollow member has a substantially constant diameter throughout the entirety of its length.

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

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

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

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

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

a nose cone shaft having a proximal end and a distal end;

a nose cone connected to the distal end of the nose cone shaft, wherein the nose cone comprises a proximally-facing opening to receive at least a first end of the replacement valve;

an inner retention shaft having a proximal end and a distal end, the inner retention shaft being slidable over the nose cone shaft;

an inner retention ring connected to the distal end of the inner retention shaft, the inner retention ring configured to engage the first end of the replacement valve;

a tether retention member on the inner retention shaft;

a locking shaft having a proximal end and a distal end, the locking shaft being slidable over the inner retention shaft, wherein the locking shaft is configured to cooperate with the tether retention member to releasably engage a tether attached to the replacement valve;

an outer elongate hollow member shaft having a proximal end and a distal end, the outer elongate hollow member shaft being slidable over the locking shaft; and

an outer elongate hollow member connected to the distal end of the outer elongate hollow member shaft, the outer elongate hollow member having a proximal end and a distal end, wherein the outer elongate hollow member is configured to cover at least the second end of the replacement valve when the first end of the replacement valve is engaged with the inner retention ring and is covered by the nose cone;

wherein the outer elongate hollow member is moveable relative to the nose cone to uncover the second end of the replacement valve while the first end of the replacement valve remains engaged to the inner retention ring and is covered by the nose cone.

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45. A method of delivering an intralumenal frame assembly to intralumenal tissue at an in situ target location, the method comprising:

delivering an intralumenal frame assembly to the in situ target location while the frame assembly is in a radially compacted state within an outer member, the frame assembly comprising a frame having a first end, a second end and a longitudinal axis extending between the first and second ends, the frame further comprising a tether encircling at least a portion of the frame, the tether configured to restrain the radial dimension of the frame;

at least partially removing the outer member from the frame assembly, wherein the tether restrains the radial dimension of the frame after the outer member is at least partially removed; and

releasing the tether from the frame to allow at least a portion of the frame assembly to radially expand.

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