Balloon mitral spacer

• US 8,894,705 B2
• Filed: 04/23/2013
• Issued: 11/25/2014
• Est. Priority Date: 10/26/2005
• Status: Active Grant

• Current Assignee: Cardiosolutions, Inc.
• Original Assignee: Cardiosolutions, Inc.
• Inventors: Eliasen, Kenneth Arden, Tallarida, Steven Joseph, Maurer, Christopher William, Wilson, Jonathan Edward
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): LAUER, CHRISTINA C
• Application Number:
  US13/868,399
• Publication Number:
  US 20130310925A1
• Time in Patent Office: 581 Days
• Field of Search: 623/2.11, 623/2.36, 623/1.24, 606/195
• US Class Current: 623/2.11
• 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 method comprising:

providing a heart valve implant comprising heart valve implant;

a shaft;

an anchor coupled to one end of the shaft, the anchor configured to secure the heart valve implant to a patient'"'"'s heart;

an expandable member coupled to a 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 resiliently deformable internal layer comprising a scaffold, wherein the expandable member defines a chamber configured to receive an inflation medium from an inflation device and to expand the expandable member from a compressed position to an expanded position; and

a valve configured to seal said inflation medium within said chamber in the expanded position after disconnection from said inflation device such that the expandable member, when in the expanded position, is configured to at least partially restrict a flow of blood through a heart valve during systole upon contact with at least a portion of at least one leaflet of the heart valve;

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.

2. The method according to claim 1, further comprising determining the size of the heart valve.

3. The method according to claim 1, wherein percutaneously inserting is performed via a catheter.

4. The method according to claim 1, further comprising detaching the expandable member from the shaft and removing the expandable member via a catheter.

5. The method according to claim 1, further comprising insufflating the expandable member via a connecting member.

6. The method according to claim 1, further comprising deflating the expandable member via a connecting member.

7. The method according to claim 1, further comprising adjustably positioning the expandable member about the shaft.

8. The method of claim 1, wherein the resiliently deformable internal layer is a scaffold structure comprising a matrix of interconnected individual members.

9. The method of claim 8, wherein the scaffold structure includes a shape memory alloy.

10. The method of claim 1, wherein the resiliently external layer is constructed out of a high silicone content, polyurethane copolymer.

11. The method of claim 1, wherein the inflation medium is selected from the group comprising at least one of a gas, liquid, gel, and/or fluoro-visible material.

12. The method of claim 1, wherein said expanding comprises expanding the expandable member with a hardening gel.

13. The method of claim 1, wherein said expanding comprises expanding the expandable member to a selectable cross-sectional diameter.

14. The method of 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.

15. The method of claim 1, wherein the expandable member is removably attached to the shaft.

16. The method of claim 1, wherein the expandable member is slidably coupled to the shaft.

17. The method of claim 1, further comprising determining the distance between a first leaflet and a second leaflet of a heart valve with said expandable member.

18. The method of claim 1, wherein the heart valve implant further comprises a connecting member removably coupled to the shaft.

19. The method of claim 1, wherein the external layer includes a plurality of ridges.

20. The method of claim 1, wherein the shaft includes an adjustment mechanism, and the method further includes axially moving the expandable member along said shaft with said adjustment mechanism.