Device and method for improving heart valve function

• US 8,932,348 B2
• Filed: 05/17/2007
• Issued: 01/13/2015
• Est. Priority Date: 05/18/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Solem, Jan Otto, Alon, David
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): LAUER, CHRISTINA C
• Application Number:
  US11/750,272
• Publication Number:
  US 20070270943A1
• Time in Patent Office: 2,798 Days
• Field of Search: 623/2.11, 623/23.72
• US Class Current: 623/2.11
• 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. An implantable device for improving the function of a mitral valve in a heart, comprising:

a flow-blocking member comprising a parachute-like portion, the parachute-like portion having an expanded state including a substantially convex proximal outer surface, the parachute-like portion configured for deployment between leaflets of the mitral valve, wherein the parachute-like portion is adapted to expand against the leaflets of the mitral valve during systole to block regurgitation of blood through the mitral valve and to collapse away from the leaflets of the mitral valve during diastole to allow blood to flow around the flow-blocking member;

an elongate body portion configured to extend downward from the flow-blocking member into a left ventricle, the elongate body portion having a body portion coupling member at a bottom end; and

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 outward when released from a delivery catheter, the prongs configured to embed into a wall of the left ventricle, the anchor having an anchor coupling member configured to protrude upward into the left ventricle after the prongs have been embedded into the wall of the left ventricle;

wherein the anchor coupling member is configured to be coupled to the body portion coupling member for allowing the body portion to be coupled to the anchor after the prongs have been embedded in the wall of the left ventricle.

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

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

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 flow-blocking member and a second end configured for attachment to a wall of the left atrium for further stabilizing the flow-blocking member.

8. An implantable device for improving the function of a heart valve in a heart, comprising:

a flow-blocking member adapted to block the flow of blood through the heart valve during systole while allowing blood to pass through the heart valve during diastole;

an elongate body portion configured to extend away from the flow-blocking member into a heart chamber; and

an expandable anchor having a plurality of prongs adapted to deflect radially outward and embed into a wall of the heart chamber;

wherein the anchor and the elongate body portion are configured to be delivered to the heart independently of one another, and wherein the anchor and the elongate body portion are configured to be connected to each other within the heart after the anchor is embedded in the wall of the heart chamber.

9. The device of claim 8, wherein the heart valve is a mitral valve and the heart chamber is a left ventricle.

10. The device of claim 8, wherein the flow-blocking member includes one or more apertures.

11. The device of claim 8, wherein the anchor further includes a tubular body, and the plurality of prongs are disposed radially about the tubular body.

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

13. The device of claim 12, further comprising at least one tether extending between a periphery of the flow-blocking member and the elongate body portion.