DEVICE AND METHOD FOR IMPROVING HEART VALVE FUNCTION

• US 20150134050A1
• Filed: 01/13/2015
• Published: 05/14/2015
• 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 O., Alon, David
• Granted Patent: US 9,827,101 B2
• Time in Patent Office: Days
• US Class Current: 623/2.1
• 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 a 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 preferably 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 method for improving the function of a mitral valve in a heart, comprising:

providing a self-expanding anchor having a tubular body and a plurality of elongated prongs radially disposed about the tubular body and adapted to deflect radially outwardly when released from a delivery catheter, the self-expanding anchor including an anchor coupling member adapted to extend upwardly into the left ventricle;

deploying the self-expanding anchor from the delivery catheter such that the plurality of elongated prongs embed into a wall of the left ventricle,

deploying a flow-blocking portion between leaflets of the mitral valve such that the flow-blocking portion expands against the leaflets of the mitral valve during systole for blocking regurgitation of blood through the mitral valve and collapses away from the leaflets of the mitral valve during diastole for allowing blood to flow around the flow-blocking member, the flow-blocking member comprising a parachute-like portion, the parachute-like portion having an expanded state including a substantially convex proximal outer surface; and

coupling an elongate body portion to the anchor coupling member, the elongate body portion attached to the flow-blocking member and extending downwardly into the left ventricle;

wherein the elongate body portion is coupled to the anchor coupling portion after the plurality of elongated prongs of the self-expanding anchor are embedded in the wall of the left ventricle.

2. The method of claim 1, further comprising at least one tether extending between a periphery of the flow-blocking member and the elongate body portion.

3. The method of claim 2, wherein the at least one tether includes a plurality of tethers.

4. The method of claim 3, wherein the parachute-like portion includes one or more apertures in the substantially convex proximal outer surface.

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

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

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

embedding an expandable anchor within a wall of a heart chamber, the expandable anchor positioned at a distal end of an elongate body portion, the anchor having a plurality of prongs adapted to deflect radially outwardly; and

deploying a flow-blocking member within a heart valve, the flow-blocking member adapted to block regurgitation of blood through the heart valve during systole while allowing blood to pass through the heart valve during diastole, wherein the flow-blocking member is coupled to the expandable anchor via the elongate body portion;

wherein the flow-blocking member is slidable along the elongate body portion relative to the expandable anchor.

8. The device of claim 7, wherein the flow-blocking member includes a parachute-like configuration adapted to expand during systole and collapse during diastole.

9. The device of claim 7, wherein the anchor further includes a tubular body and the plurality of prongs are disposed radially about the tubular body.

10. The device of claim 7, wherein the flow-blocking member is configured to be positioned between leaflets of the heart valve.

11. The device of claim 7, wherein a distal end of the elongate body portion includes a coupling member configured to connect to an anchor coupling member of the anchor.

12. The device of claim 7, wherein the flow-blocking member includes an aperture.