Balloon Mitral Spacer

• US 20070255399A1
• Filed: 05/14/2007
• Published: 11/01/2007
• Est. Priority Date: 10/26/2005
• Status: Active Grant

• Current Assignee: Cardiosolutions, Inc.
• Original Assignee: Cardiosolutions, Inc.
• Inventors: Eliasen, Kenneth, Maurer, Christopher, Tallarida, Steven, Wilson, Jonathan
• Granted Patent: US 8,449,606 B2
• Time in Patent Office: Days
• US Class Current: 623/2.360
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

A heart valve implant according to one embodiment may include a shaft and an anchor disposed on one end of the shaft, the anchor configured to engage tissue. The heart valve implant may further include an expandable member disposed over at least part of the shaft, the expandable member comprising a resiliently deformable internal layer and a resiliently deformable external layer disposed over the internal layer, the expandable member defining a chamber and being configured to receive an inflation medium in the chamber to expand the expandable member, the expandable member further configured to deform upon contact with at least a portion of at least one leaflet of a heart valve to at least partially conform to the shape of the leaflet.

Claims

1. A heart valve implant comprising:

a shaft;

an anchor disposed on one end of the shaft, the anchor configured to engage tissue; and

an expandable member disposed over at least part of the shaft, the expandable member comprising a resiliently deformable internal layer and a resiliently deformable external layer disposed over the internal layer, the expandable member defining a chamber and being configured to receive an inflation medium in the chamber to expand the expandable member, the expandable member further configured to deform upon contact with at least a portion of at least one leaflet of a heart valve to at least partially conform to the shape of the leaflet.

2. The heart valve implant according to claim 1, wherein the resiliently deformable internal layer is a scaffold structure comprising a matrix of interconnected individual members.

3. The heart valve implant according to claim 2, wherein the scaffold structure includes a shape memory alloy.

4. The heart valve implant according to claim 1, wherein the resiliently deformable internal layer includes a foam material.

5. The heart valve implant according to claim 1, wherein the resiliently external layer is constructed out of a high silicone content, polyurethane copolymer.

6. The heart valve implant according to claim 1, wherein the inflation medium is selected from the group comprising at least one of a gas, liquid, gel, and/or flouro-visible material.

7. The heart valve implant according to claim 1, wherein the expandable member is further configured to receive a hardening gel.

8. The heart valve implant according to claim 1, wherein the expandable member is controllably expandable to expand the member to a selectable cross-sectional diameter.

9. The heart valve implant according to claim 1, wherein the expandable member is expanded to a shape selected from the group consisting of round, pear-shaped, elliptical, hourglass-shaped, oval and heart-shaped.

10. The heart valve implant according to claim 1, wherein the expandable member is removably attached to the shaft.

11. The heart valve implant according to claim 1, wherein the expandable member is slidably coupled to the shaft.

12. The heart valve implant according to claim 1, wherein the expandable member is configured to determine the distance between a first leaflet and a second leaflet of a heart valve.

13. The heart valve implant according to claim 1, further comprising a connecting member removably coupled to the shaft.

14. The heart valve implant according to claim 1, wherein the external layer includes a plurality of ridges.

15. The heart valve implant according to claim 1, wherein the shaft includes an adjustment mechanism configured to permit the axial movement of the expandable member along the shaft.

16. A method comprising:

providing a heart valve implant comprising a shaft, an anchor operatively connected to the shaft and an expandable member operatively connected to the shaft;

at least partially collapsing the heart valve implant;

percutaneously inserting the at least partially collapsed heart valve implant into a heart;

securing the at least partially collapsed heart valve implant within the heart; and

expanding the collapsed heart valve implant to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through the heart valve in a closed position.

17. The method according to claim 16, further comprising determining the size of a heart valve.

18. The method according to claim 16, wherein percutaneously inserting is performed via a catheter.

19. The method according to claim 16, further comprising detaching the expandable member from the shaft and removing the expandable member via a catheter.

20. The method according to claim 16, further comprising insufflating the expandable member via a connecting member.

21. The method according to claim 16, further comprising deflating the expandable member via a connecting member.

22. The method according to claim 16, further comprising adjustably positioning the expandable member about the shaft.