Valve prosthesis fixation techniques using sandwiching

• US 10,195,033 B2
• Filed: 06/26/2017
• Issued: 02/05/2019
• 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): Sweet, Thomas J
• Assistant Examiner(s): Shipmon, Tiffany
• Application Number:
  US15/632,426
• Publication Number:
  US 20180000582A1
• Time in Patent Office: 589 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 2/2418 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 prosthetic apparatus for implantation at a native valve complex includes a main body configured for placement within the native valve, at least one downstream arm and at least one upstream arm, each coupled to and disposed outside of the main body. The main body includes a compressed state for delivery and an expanded state. In the expanded state, a space exists between the downstream arm and an outer surface of the main body to receive an edge of a native valve leaflet. A portion of the downstream arm is configured to extend behind the received native leaflet and engage a downstream surface of the native valve complex while the edge of the received native leaflet is not engaged by the downstream arm. The upstream arm is configured to engage an upstream surface of the native valve complex at a location opposite the portion of the downstream arm.

Claims

1. A prosthetic apparatus for implanting at a native valve complex of a heart, the native valve having a native annulus and native valve leaflets, the prosthetic apparatus comprising:

a main body configured for placement within the native valve, the main body being compressible to a compressed state for delivery into the heart and expandable from the compressed state to an expanded state;

at least one downstream arm coupled to and disposed outside of the main body such that, in the expanded state, a space exists between the downstream arm and an outer surface of the main body to receive an edge of a native valve leaflet, a portion of the downstream arm being configured to extend behind the received native leaflet and engage a downstream surface of the native valve complex, while the edge of the received native leaflet is not engaged by the downstream arm; and

at least one upstream arm coupled to and disposed outside of the main body, the at least one upstream arm being configured to engage an upstream surface of the native valve complex, at a location opposite the portion of the downstream arm.

2. The prosthetic apparatus of claim 1, further comprising a valve portion coupled within the main body, the valve portion comprising valve leaflets that form a one-way valve within the main body.

3. A prosthetic valve for implanting at a native valve of a heart, the native valve having a native annulus and native valve leaflets, the prosthetic valve comprising:

an inner support member configured for placement within the native valve, the inner support member being compressible to a compressed state for delivery into the heart and expandable from the compressed state to an expanded state;

a valve portion coupled within the inner support member, the valve portion comprising valve leaflets that form a one-way valve within the inner support member; and

an outer support member coupled to a distal portion of the inner support member and extending in a proximal direction lengthwise of the inner support member, the outer support member disposed outside of the inner support member such that, in the expanded state, a space exists between the outer support member and an outer surface of the inner support member, an upstream portion of the outer support member being configured for placement within the native valve and to engage the native valve.

4. The prosthetic valve of claim 3, further comprising a downstream portion of the outer support member being configured to engage the native valve, at a location opposite the upstream portion.

5. The prosthetic valve of claim 3, wherein the prosthetic valve is configured for implantation at the native mitral valve of the heart.

6. The prosthetic valve of claim 3, wherein the prosthetic valve is configured for implantation at the native aortic valve of the heart.

7. The prosthetic valve of claim 3, wherein at least a proximal portion of the outer support member is configured to self-expand to a radially extended state when released from a delivery sheath while at least a portion of the inner support member is retained in a radially compressed state by the delivery sheath.

8. The prosthetic valve of claim 3, wherein at least a proximal portion of the outer support member is configured to self-expand to a radially extended state when released from a delivery sheath while the entire inner support member is retained in a radially compressed state by a delivery sheath.

9. The prosthetic valve of claim 3, wherein the outer support member comprises one or more tissue piercing elements.

10. The prosthetic valve of claim 3, wherein the outer support member comprises one or more barbs.

11. The prosthetic valve of claim 3, wherein at least a portion of the outer support member comprises a covering.

12. The prosthetic valve of claim 3, wherein at least a portion of upstream portion of the outer support member is configured to engage an upstream surface of the native valve.

13. The prosthetic valve of claim 12, further comprising a downstream portion of the outer support member being configured to engage a downstream surface of the native valve, at a location opposite the upstream portion.