Prosthetic insert for treating a mitral valve

• US 8,968,395 B2
• Filed: 04/04/2012
• Issued: 03/03/2015
• Est. Priority Date: 06/01/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Hauser, David L., Solem, Jan Otto, Alon, David
• Primary Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US13/439,336
• Publication Number:
  US 20120191182A1
• Time in Patent Office: 1,063 Days
• Field of Search: 623/2.11, 623/2.15, 623/2.17, 623/2.18, 623 236- 238
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• 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 2002/0835 with deformation of anchor parts, e.g. expansion of dowel by set screw
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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

Abstract

A prosthetic insert member for improving the function of a mitral valve is disclosed. The insert member is configured for insertion between leaflets of mitral valve. The insert member has an elongated cross-sectional profile for conforming to the opening in the mitral valve. The device also includes an anchoring member for attachment to heart tissue for maintaining the insert member in the mitral valve. In operation, the insert member fills the opening between the leaflets of the mitral valve and reduces regurgitation while preferably allowing the leaflets to function in a substantially normal manner. In one embodiment, the insert member is formed with a valve member disposed in a passageway for allowing blood to pass through the insert member in one direction.

Claims

1. A device for treating a mitral valve, comprising:

a collapsible and expandable prosthetic insert member having first and second longitudinally extending walls, the first and second longitudinally extending walls defining an elongated, crescent-shaped, cross-sectional profile, the insert member having a height sized to extend above and below the mitral valve such that the leaflets of the mitral valve contact the first and second walls of the insert member during ventricular systole for creating a tight seal to prevent regurgitation of blood from the left ventricle to the left atrium, the insert member shaped for permitting the leaflets of the mitral valve to open and close, the insert member formed with a passageway between the first and second walls and a valve member comprising at least one leaflet, the valve member disposed within the passageway for allowing blood to flow through the passageway of the insert member from the left atrium to the left ventricle;

an anchoring member coupled to the insert member, the anchoring member comprising an elongated body portion; and

a penetration member adapted for engaging tissue along a wall of the left ventricle, the penetration member coupled to a bottom end of the elongated body portion,

wherein the anchoring member is dimensioned for positioning the insert member between the leaflets of the mitral valve when the penetration member is engaged with tissue near an apex of the left ventricle,

wherein the elongated, crescent-shaped cross-sectional profile is dimensioned to conform to an opening between the native leaflets of the mitral valve.

2. The device of claim 1, wherein the insert member comprises an outer layer defining the first and second walls of the insert member, the outer layer comprising a biological material to inhibit abrasion of the leaflets of the mitral valve when the leaflets contact the first and second walls of the insert member.

3. The device of claim 2, wherein the outer layer is formed of pericardial tissue.

4. The device of claim 1, further comprising two plates configured to be disposed on opposite sides of the heart wall for anchoring the penetration member.

5. The device of claim 1, wherein the insert member is self-expandable.

6. A system for treating a mitral valve, comprising:

a delivery catheter;

a prosthetic insert member having a collapsed state and an expanded state, wherein the insert member has an elongated-crescent-shaped, cross-sectional profile in the expanded state for insertion between the leaflets of the mitral valve, the insert member adapted for plugging a gap between the leaflets of the mitral valve and reducing regurgitation, while permitting the leaflets to open and close, the insert member having an outer surface formed with biological tissue;

an anchoring member coupled to the insert member, the anchoring member comprising an elongated body portion for positioning the insert member between the leaflets of the mitral valve when the penetration member is engaged with tissue near an apex of the left ventricle; and

a penetration member adapted for engaging tissue along a wall of the left ventricle, the penetration member coupled to a bottom end of the elongated body portion,

wherein the elongated, crescent-shaped, cross-sectional profile is dimensioned to conform to an opening between leaflets of the mitral valve, and

wherein the prosthetic insert member is capable of reducing regurgitation through the mitral valve,

wherein the insert member includes a passageway extending along a longitudinal axis and a valve member disposed within the passageway.

7. The device of claim 6, wherein the penetration member comprises a plurality of radially-expandable engagement members for penetrating the tissue.

8. A device for treating a mitral valve, comprising:

a collapsible and expandable prosthetic insert member shaped for contacting the leaflets of the mitral valve, while permitting the leaflets to open and close, the insert member formed with a passageway and a valve member disposed within the passageway for allowing blood to flow through the insert member from the left atrium to the left ventricle;

an anchoring member coupled to the insert member, the anchoring member comprising an elongated body portion; and

a penetration member adapted for engaging tissue along a wall of the left ventricle, the penetration member coupled to a bottom end of the elongated body portion,

wherein the device is configured for anchoring only to the wall of the left ventricle, and

wherein the device for treating a mitral valve is configured to improve the function of the mitral valve by reducing regurgitation.

9. The device of claim 8, wherein the insert member has a flattened and elongated cross-sectional profile.