Actively controllable heart valve implant and method of controlling same

• US 10,226,335 B2
• Filed: 06/22/2016
• Issued: 03/12/2019
• Est. Priority Date: 06/22/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Cartledge, Richard, Deville, Derek Dee, Smith, Kevin W., Greene, James L., Jimenez, Jorge
• Primary Examiner(s): Snow, Bruce E
• Application Number:
  US15/189,786
• Publication Number:
  US 20160367360A1
• Time in Patent Office: 993 Days
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/0052 T-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability

Abstract

A mitral valve implant includes a force-expanding mitral valve lattice having an interior orifice and a self-expanding valve trampoline attached at the interior orifice of the force-expanding mitral valve lattice. The mitral valve lattice is self-expandable to a first configuration and force expandable from the first configuration to a second configuration. The configurations can be circular or D-shaped. The mitral valve lattice comprises jack screws adjusting configurations of the mitral valve lattice. The valve trampoline has a cylindrical central region comprising valve leaflets. An outwardly flaring implant skirt is attached to the mitral valve lattice exterior. Wall-retaining wires are attached to the mitral valve lattice, are petal-shaped, and have a pre-set, radially outward, memory shape. The wires and skirt impart a force on a respective side of the native mitral valve when the mitral valve lattice is expanded within an annulus of the native mitral valve.

Claims

1. A mitral valve implant, comprising:

an expandable mitral valve lattice having an inflow end portion and an outflow end portion;

a self-expanding valve trampoline lattice attached to the outflow end portion of the mitral valve lattice;

a self-expanding skirt lattice attached to an exterior surface of the mitral valve lattice, wherein the skirt lattice is covered by a fluid-resistant material; and

a plurality of jack screws rotatably connected to the mitral valve lattice,

wherein the mitral valve lattice is configured to self-expand from a compressed configuration to a first expanded configuration, and

wherein the jack screws are configured to expand the mitral valve lattice from the first expanded configuration to a second expanded configuration, which is radially larger than the first expanded configuration.

2. The implant according to claim 1, wherein the first expanded configuration is one of circular and D-shaped.

3. The implant according to claim 2, wherein the second expanded configuration corresponds in shape to the one of circular and D-shaped first expanded configuration.

4. The implant according to claim 1, wherein the jack screws are configured to compress the mitral valve lattice from the second expanded configuration to the first expanded configuration.

5. The implant according to claim 1, wherein the mitral valve lattice is made of a shape memory material and is shape-set to the first expanded configuration.

6. The implant according to claim 1, wherein the valve trampoline lattice has a cylindrical central region comprising valve leaflets.

7. The implant according to claim 6, wherein the valve trampoline lattice comprises a D-shaped portion.

8. The implant according to claim 7, wherein:

the valve leaflets have an inflow side; and

the D-shaped portion is located on an inflow side of the valve leaflets.

9. The implant according to claim 1, wherein the skirt lattice has an outflow end portion that extends radially outwardly relative to the mitral valve lattice and has a first outer diameter, and wherein the first outer diameter of the skirt lattice is larger than a second outer diameter of the valve trampoline lattice.

10. The implant according to claim 9, wherein the skirt lattice has an inflow end portion comprising wall-retaining wires extending radially outwardly relative to the mitral valve lattice, wherein the wall-retaining wires are shaped to be positioned on a side of the native mitral valve.

11. The implant according to claim 10, wherein the wall-retaining wires are in the shape of petals and have a pre-set, radially outward, memory shape to impart a force on the side of the native mitral valve when the mitral valve lattice is expanded within an annulus of the native mitral valve.

12. The implant according to claim 11, wherein:

the outflow end portion of the skirt lattice is shaped to be positioned on a ventricular side of the native mitral valve when the mitral valve lattice is expanded within the annulus of the native mitral valve; and

the wall-retaining wires of the skirt lattice are shaped to be positioned on an atrial side of the native mitral valve when the mitral valve lattice is expanded within the annulus of the native mitral valve.

13. The implant according to claim 1, wherein the valve trampoline lattice has an inflow end portion attached to the outflow end portion of the mitral valve lattice, and wherein the skirt lattice has an outflow end portion that has a larger diameter than diameters of the inflow end portions of the mitral valve lattice and the valve trampoline lattice.

14. The implant according to claim 1, wherein when the mitral valve lattice is in the second expanded configuration, an outflow end portion of the valve trampoline lattice is spaced radially inwardly from the outflow end of the mitral valve lattice.