Devices and methods for delivery of valve prostheses

• US 9,907,650 B2
• Filed: 09/20/2013
• Issued: 03/06/2018
• Est. Priority Date: 03/30/2009
• Status: Active Grant

• Current Assignee: JC Medical, Inc.
• Original Assignee: Suzhou Jiecheng Medical Technology Co., Ltd
• Inventors: Zhang, Ji
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): NGUYEN, TIN DUC
• Application Number:
  US14/033,054
• Publication Number:
  US 20140052240A1
• Time in Patent Office: 1,628 Days
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2/9661 the proximal portion of the stent or stent-graft is released first
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/006 modular

Abstract

A valve prosthesis and implantation device, and methods for use are provided. The devices may be used for transcatheter delivery of an aortic valve prosthesis or transapical delivery of a mitral valve prosthesis. The implantation device utilizes movable claspers for both positioning and anchoring the valve prosthesis, reducing the extent of imaging needed during the implantation procedure.

Claims

1. An implantation device, comprising

a valve prosthesis comprising a support frame radially expandable between a compact condition and an expanded condition, the support frame having an outer surface and a longitudinal axis along an inflow-outflow direction and defining a central orifice about the longitudinal axis and at least one valve clasper movably attached to the support frame such that during valve delivery the at least one valve clasper is movable relative to the support frame along the longitudinal axis and between a nesting position with the outer surface of the support frame and an engagement position with a native cardiac valve sinus wherein the at least one valve clasper is physically separated from the support frame, and

a delivery device comprising

a control unit;

and

at least one track wire, the at least one track wire having a proximal end attached to the control unit and a distal end for contact with the at least one valve clasper.

2. The implantation device of claim 1, further comprising a first sheath which at least partially encases the support frame.

3. The implantation device of claim 2, further comprising a second sheath which at least partially encases the at least one valve clasper.

4. The implantation device of claim 3, wherein the first sheath is positioned serially and distally to the second sheath.

5. The implantation device of claim 3, wherein the second sheath is positioned serially and distally to the first sheath.

6. The implantation device of claim 2, wherein prior to delivery of the valve prosthesis, the support frame is fully encased by the first sheath.

7. The implantation device of claim 1, wherein the at least one track wire is reversibly attached to the at least one valve clasper.

8. The implantation device of claim 1, wherein the at least one valve clasper comprises three u-shaped members.

9. The implantation device of claim 1, wherein the at least one valve clasper is a multiplex unit comprising two or more u-shaped members and two or more apex members, wherein a first u-shaped member is permanently attached to a second u-shaped member via a first apex member and a second apex member.

10. The implantation device of claim 1, wherein the at least one valve clasper is a multiplex unit comprising three u-shaped members and three apex members, wherein each of the three u-shaped members is permanently attached to another of the three u-shaped members via one of the three apex members.

11. The implantation device according to claim 1, wherein the at least one valve clasper is comprised of a shape memory metal.

12. The implantation device of claim 1, wherein the support frame is comprised of a shape memory metal.

13. The implantation device of claim 1, wherein a plurality of leaflets is attached to the support frame, wherein the plurality of leaflets provides a one-way valve in the central orifice when the support frame is in its expanded condition.

14. The implantation device of claim 1, wherein the valve prosthesis comprises three valve claspers coupled to each other at respective apex members thereof, wherein the valve prosthesis further comprises three leg members coupled to and extending longitudinally from the apex members between adjacent valve claspers.

15. The implantation device of claim 14, wherein the three leg members each comprise barbs extending therefrom.

16. The implantation device of claim 1, wherein the valve prosthesis comprises three valve claspers, wherein each valve clasper comprises a u-shaped member and opposing apex members extending from the u-shaped member, wherein each apex member is curved.

17. The implantation device of claim 16, wherein adjacent valve claspers are joined together via the apex members, each apex member having a vertex, and wherein adjacent apex members intersect to form a valley between the vertices of the adjacent apex members.

18. The implantation device of claim 17, further comprising a hole formed between the adjacent apex members.

19. The implantation device of claim 1, wherein the valve prosthesis comprises three valve claspers that are joined together in series at respective apex joints, each apex joint having two vertices and a valley interposed between the two vertices.

20. The implantation device of claim 19, wherein each apex joint comprises a hole formed therein.