DEVICE AND METHOD FOR IMPROVING HEART VALVE FUNCTION

• US 20070270943A1
• Filed: 05/17/2007
• Published: 11/22/2007
• Est. Priority Date: 05/18/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Solem, Jan Otto, Alon, David
• Granted Patent: US 8,932,348 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0453 threaded elements, e.g. set screws
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2240/002 Designing or making customized prostheses

Abstract

The invention is device and method for reducing regurgitation through a mitral valve. The device and method is directed to an anchor portion for engagement with the heart wall and an expandable valve portion configured for deployment between the mitral valve leaflets. The valve portion is expandable for preventing regurgitation through the mitral valve while allowing blood to circulate through the heart. The expandable valve portion may include apertures for reducing the stagnation of blood. In a preferred configuration, the device is configured to be delivered in two-stages wherein an anchor portion is first delivered and the valve structure is then coupled to the anchor portion. In yet another embodiment, the present invention provides a method of forming an anchor portion wherein a disposable jig is used to mold the anchor portion into a three-dimensional shape for conforming to a heart chamber.

Claims

1. A device for improving the function of a valve in a heart, comprising:

a flow-blocking member configured for insertion between the leaflets of the valve;

a body portion extending from the flow-blocking member, the body portion having a body portion coupling member; and

an anchor having a first portion configured to be secured to the body portion and a second portion configured for securement within a wall of the heart on a first side of the valve;

wherein the anchor first portion includes an anchor coupling member configured to be coupled to a body portion coupling member for allowing the body portion to be coupled to the anchor after the anchor has been secured to the wall of the heart.

2. The device of claim 1, wherein the flow-blocking member comprises an expandable member.

3. The device of claim 2, wherein the expandable member comprises a canopy portion and tethers for attaching the canopy portion to the body portion.

4. The device of claim 3, wherein the canopy portion is formed with one or more apertures.

5. The device of claim 1, wherein the anchor comprises an anchor line coupling member configured to receive and hold an anchor line.

6. The device of claim 1, wherein the anchor has an unexpanded configuration and an expanded configuration, and the anchor is biased toward the expanded configuration.

7. The device of claim 1, further comprising:

a leash, the leash having a first end attached to the canopy portion and a second end configured for attachment to the heart wall on a second side of the valve, wherein the second side of the valve is opposite to the first side of the valve.

8. A method for improving the function of a valve in a heart of a patient, comprising:

providing a flow-blocking member configured to at least partially block bloodflow through the valve;

accessing a first chamber of the human heart;

deploying an anchor in the heart wall within the first chamber;

coupling the expandable member to the anchor; and

disposing the expandable member between the leaflets of the valve.

9. The method of claim 8, wherein the flow-blocking member comprises an expandable member, the expandable member having an expanded configuration for preventing bloodflow through the valve, the expandable member having a contracted configuration for allowing bloodflow through the valve.

10. The method of claim 8, wherein the anchor portion is configured to encourage tissue ingrowth thereon, and coupling the expandable member to the anchor is performed after the anchor portion has been deployed and after at least some tissue ingrowth has occurred.

11. The method of claim 8, wherein accessing the chamber of the human heart comprises accessing the human heart through an opening in the patient'"'"'s chest wall.

12. The method of claim 8, further comprising:

coupling the flow-blocking member to the heart wall within a second chamber via a leash.

13. A system for improving the function of a valve in the heart of a patient, comprising:

a treatment device having an anchor portion and a flow-blocking portion, wherein the anchor portion is configured to be secured to the flow-blocking portion;

a first delivery catheter configured to deliver the anchor portion within a chamber of the heart and to secure the anchor portion to the heart wall of the chamber;

a second delivery catheter configured to delivery the flow-blocking portion within the chamber of the patient'"'"'s heart and to secure the flow-blocking portion to the anchor portion.

14. The system of claim 13, further comprising:

an anchor line passing from the anchor portion to a position outside of the patient.

15. The system of claim 14, wherein the second catheter is configured to be advanced along the anchor line to the anchor portion.

16. The system of claim 14, wherein the anchor line is releasably secured to the anchor portion.

17. The system of claim 16, wherein the anchor line comprises an anchor connection, the anchor portion comprises an anchor line connection, and the anchor connection is configured to interactively connect with the anchor line connection.

18. The system of claim 17, wherein the anchor line comprises a wire, and the anchor connection comprises a threaded screw-like member.

19. The system of claim 13, wherein the first delivery catheter comprises a distal end containing the anchor portion, and the first delivery catheter further comprises an expandable balloon positioned on the distal end.

20. The system of claim 13, wherein the anchor portion has an expanded condition and an unexpanded condition, wherein the anchor portion is biased toward the expanded condition, and wherein the first catheter comprises a distal end sheath and the anchor portion is slidingly positioned within the distal end sheath.