Annuloplasty devices and related heart valve repair methods

• US 20040167620A1
• Filed: 02/26/2004
• Published: 08/26/2004
• Est. Priority Date: 07/06/2000
• Status: Active Grant

• Current Assignee: Medtentia International Ltd. Oy
• Original Assignee: Medtentia
• Inventors: Ortiz, Mark, Spence, Paul A., Whedon, Randy
• Granted Patent: US 6,964,684 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0033 electrically, e.g. heated by resistor
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/006 modular

Abstract

Devices for repairing and replacing a heart valve in various embodiments, the devices include at least first and second support rings connected together in a coiled configuration to abut opposite sides of a valve annulus. A replacement valve may be secured to the coil-shaped device. Various alternative fastening systems include suture fastening systems, mechanical fastening systems, shape memory alloy fastening systems and other fastening systems relying only on the resilience between adjacent coils. A method generally includes inserting a first end of the coil-shaped member through a valve annulus, rotating a first ring of the coil-shaped member into position on one side of the valve annulus and positioning at least a second ring of the coil-shaped member on an opposite side of the valve annulus.

Claims

1. A device for repairing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the device comprising:

a valve support device configured for attachment to at least one side of the heart valve, and

a coil-shaped carrier removably coupled with said valve support device for allowing said valve support device to be turned into position on said at least one side and secured to a portion of the valve tissue to support the heart valve.

2. A device for repairing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the device comprising:

a catheter having a lumen and an open end,

an elongate valve support member carried within said lumen and movable from said open end, said elongate valve support member having an uncoiled configuration within said lumen and assuming a coiled configuration when extended from said open end.

3. The device of claim 2, wherein said elongate valve support member including an inner core covered by an outer layer, said inner core formed from a more rigid material than said outer layer.

4. The device of claim 2, wherein said elongate valve support member has a generally triangular-shaped cross section.

7. The device of claim 2, wherein said elongate valve support member is formed from a shape memory alloy.

5. The device of 2 further comprising:

an actuator carried within said lumen and operable to extend said elongate valve support member from said open end.

6. The device of claim 5, wherein said actuator further comprises a gripping element operable to grip and allow releasing of one end of said elongate valve support member.

8. A device for repairing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the device comprising:

a first support member at least partially formed from a shape memory alloy operable to assume an activated shape and an inactivated shape, and

a second support member at least partially formed from said shape memory alloy and connected to said first support member, said first support member configured to abut one side of the valve and said second support member configured to abut an opposite side of the valve, whereby a portion of the valve tissue is trapped between said first and second support members upon said shape memory alloy assuming said activated shape.

9. The device of claim 8, wherein said first and second support members are ring shaped.

10. The device of claim 8 further comprising:

a plurality of fastening elements on at least one of said first and second support members for engaging the valve tissue when the shape memory alloy is in the activated shape.

11. The device of claim 10, wherein said first support member includes at least one projection and said second support member includes at least one fastening portion to receive said projection.

12. A method of replacing a heart valve of a patient, the method comprising:

inserting a first end of a coil-shaped support through an area of valve tissue,

rotating at least a first ring of the coil-shaped support to position the first ring on a first side of the valve tissue,

positioning at least a second ring of the coil-shaped support on an opposite second side of the valve tissue,

coupling a replacement valve to at least one of the first and second rings, and

wherein coupling the replacement valve further comprises suturing a cuff on the replacement valve to a cuff on one of the first and second rings.

13. The method of claim 12, wherein coupling the replacement valve further comprises suturing a cuff on the replacement valve to a cuff on one of the first and second rings.

14. The method of claim 12, wherein coupling the replacement valve further comprises rotating the replacement valve into sealing engagement with one of the first and second rings.

15. The method of claim 12, wherein coupling the replacement valve further comprises rotating a cuff on the replacement valve over one of the first and second rings.

16. The method of claim 12, wherein coupling the replacement valve further comprises activating a fastening element formed from a shape memory alloy.