Catheter for implanting a valve prosthesis

• US 9,642,704 B2
• Filed: 10/16/2009
• Issued: 05/09/2017
• Est. Priority Date: 09/19/2006
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Inventors: Tuval, Yosi, Kilemnik, Ido, Benary, Raphael
• Primary Examiner(s): Templeton, Christopher L
• Application Number:
  US12/580,662
• Publication Number:
  US 20100137979A1
• Time in Patent Office: 2,762 Days
• Field of Search: 623 211, 623 111
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 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 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A catheter system configured to deploy a valve prosthesis can include a catheter tip at a distal end of the catheter system. The catheter tip can include a device holder releasably connected to and retaining the prosthesis. The catheter tip can also include a first housing portion that accommodates the first portion of the prosthesis, and a second housing portion that accommodates the second portion of the prosthesis. The first housing portion and the second housing portion are configured to move relative to one another such that the catheter system sequentially releases the prosthesis to an expanded state by uncovering the second portion of the prosthesis allowing the second portion of the prosthesis to expand.

Claims

1. A combination of a prosthesis and a catheter system for use in treating a heart valve, comprising:

the prosthesis comprising a frame and a prosthetic valve coupled to the frame, the prosthesis including an inflow end and an outflow end, wherein the prosthesis is configured for blood flow through the prosthesis from the inflow end to the outflow end, the frame comprising engagement arms that are configured, upon implantation, to

extend radially outward from a main body portion of the frame, and

be disposed radially outside of leaflets of the heart valve,

wherein the number of engagement arms equals the number of the leaflets of the heart valve;

the catheter system comprising;

a first housing portion configured to accommodate the inflow end of the prosthesis in a collapsed configuration; and

a second housing portion comprising a distal cap disposed distal of the first housing portion, wherein, the outflow end of the prosthesis and at least a portion of the engagement arms are disposed within an interior space of the second housing portion in a collapsed configuration and the inflow end of the prosthesis is disposed within the first housing portion,

wherein longitudinal ends of the first housing portion and the second housing portion face each other such that a proximally facing longitudinal end of the second housing portion faces a distally facing longitudinal end of the first housing portion when both the inflow end of the prosthesis and the engagement arms are disposed respectively within the first housing portion and the second housing portion,

wherein the first housing portion and the second housing portion are configured to move such that the catheter system sequentially releases the prosthesis to an expanded state by uncovering the engagement arms allowing the engagement arms to pivot outwardly while the inflow end of the prosthesis is accommodated within the catheter system.

2. The combination of claim 1, wherein the catheter system is configured for a transapical delivery of the prosthesis to the heart valve.

3. The combination of claim 1, further comprising a shaft coupled to the second housing portion, the shaft passing through an interior space of the first housing portion.

4. The combination of claim 1, wherein the heart valve is selected from the group consisting of a mitral valve, an aortic valve, a pulmonary valve, and a tricuspid valve.

5. The combination of claim 1, wherein the frame is fabricated as one integrated structure.

6. The combination of claim 1, wherein the frame is fabricated as separate components that are joined together.

7. The combination of claim 1, wherein the prosthesis is fabricated as separate components that are joined together before implantation.

8. The combination of claim 1, wherein the catheter system is configured for a transarterial delivery of the prosthesis to the heart valve.

9. The combination of claim 1, wherein the catheter system is configured for an endovascular-percutaneous delivery of the prosthesis to the heart valve.

10. The combination of claim 1, wherein the catheter system is configured for a transaortic delivery of the prosthesis to the heart valve.

11. The combination of claim 1, wherein the catheter system is configured for a transseptal delivery of the prosthesis to the heart valve.

12. The combination of claim 1, wherein the inflow end of the prosthesis comprises a flared portion.

13. The combination of claim 1, wherein the engagement arms are circumferentially spaced apart so as to define gaps therebetween, and wherein, upon implantation of the prosthesis, the engagement arms are configured to be positioned in rotational alignment with the leaflets of the heart valve, wherein the gaps are configured to be positioned in rotational alignment with commissures of the heart valve, and wherein the prosthesis is configured to trap without folding over the leaflets of the heart valve.

14. The combination of claim 1, wherein the catheter system is configured to uncover the engagement arms by moving the second housing portion distally relative to the first housing portion.

15. The combination of claim 14, wherein the catheter system is configured such that after the second housing portion is moved distally relative to the housing portion to uncover the engagement arms, the first housing portion is configured to be moved proximally relative to the second housing portion to release the inflow end of the prosthesis.

16. The combination of claim 15, wherein the catheter system is configured such that after the first housing portion is moved relative to the second housing portion to release the inflow end of the prosthesis, the second housing portion is configured to be moved distally to release the outflow end of the prosthesis.

17. The combination of claim 16, wherein the inflow end of the prosthesis comprises a skirt portion of the prosthesis.

18. A combination of a prosthesis and a catheter system for use in treating a heart valve, comprising:

the prosthesis comprising a frame and a prosthetic valve coupled to the frame, the frame including an inner support structure having an inflow end and an outflow end, wherein the prosthesis is configured for blood flow through the prosthesis from the inflow end to the outflow end, and engagement arms attached to the outflow end of the frame, wherein the number of engagement arms equals the number of the leaflets of the heart valve;

wherein the engagement arms are configured, upon implantation, to extend radially outward from a main body portion of the frame and be disposed radially outside of leaflets of the heart valve;

the catheter system comprising;

a first housing portion configured to accommodate the inflow end of the frame in a collapsed configuration; and

a second housing portion comprising a distal cap disposed distal of the first housing portion, wherein, the outflow end of the frame and at least a portion of the engagement arms are disposed within an interior space of the second housing portion in a collapsed configuration and the inflow end of the frame is disposed within the first housing portion,

wherein the second housing portion is configured to be moved distally to uncover the engagement arms allowing the engagement arms to pivot outwardly while the inflow end of the frame is disposed within the first housing portion in the collapsed configuration and the outflow end of the frame is disposed within the second housing portion in the collapsed configuration,

wherein after the second housing portion is moved distally, the first housing portion is configured to be moved proximally to uncover the inflow end of the frame allowing the inflow end of the frame to radially expand, and

wherein after the first housing portion is moved proximally, the second housing portion is configured to be moved further distally to uncover the outflow end of the frame allowing the outflow end of the frame to radially expand.

19. The combination of claim 18, wherein after the second housing portion is moved distally and before the first housing portion is moved proximally, the catheter system is configured to be moved proximally or distally such that the prosthesis is moved proximally or distally with the catheter system.