Annuloplasty Ring with Anchors Fixed by Curing Polymer

• US 20120296419A1
• Filed: 09/23/2011
• Published: 11/22/2012
• Est. Priority Date: 05/17/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Richardson, Leonard B., Edmunds, Kevin D.
• Granted Patent: US 8,523,940 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

Annuloplasty rings and methods for inserting annuloplasty rings are herein disclosed. The annuloplasty ring has a ring shell and a plurality of anchoring fasteners for anchoring the ring shell to adjacent hear tissue. To maintain the shape of the annuloplasty ring upon attachment of the ring to the patient'"'"'s heart, a hardening polymer is inserted into the ring shell, which is permitted to cure, thereby providing support for the annuloplasty ring and the patient'"'"'s heart valve.

Claims

1. An annuloplasty device comprising:

a deployed configuration and an undeployed configuration;

a ring shell, the ring shell defining an outer surface of the device;

a plurality of anchoring fasteners each having a first end and a second end, the first end disposed within the ring shell;

the second end extending exteriorly to the ring shell when the device is in the deployed configuration; and

a hardening polymer disposed within the ring shell when the device is in the deployed configuration.

2. The annuloplasty device of claim 1 further comprising a stiffening wire disposed within the ring shell.

3. The annuloplasty device of claim 1 further comprising a stiffening member disposed within the ring shell.

4. The annuloplasty device of claim 1 further comprising an expandable balloon disposed within the ring shell, the expandable balloon contacting the plurality of anchoring fasteners upon expansion of the expandable balloon.

5. The annuloplasty device of claim 1 further comprising a sheath, the sheath extending exteriorly to the ring shell when the device is in the undeployed configuration.

6. The annuloplasty device of claim 1 further comprising an injection port located on the ring shell.

7. The annuloplasty device of claim 6 further comprising at least one fill tube, the at least one fill tube connected to the injection port.

8. A method of treating a heart valve comprising:

providing an annuloplasty ring having a ring shell and a plurality of anchoring fasteners;

inserting the annuloplasty ring into the heart adjacent to the heart valve;

securing the anchoring fasteners into a portion of the heart;

providing a polymer;

injecting the polymer into the ring shell; and

hardening the polymer.

9. The method of claim 8, wherein the polymer comprises a radiopaque material.

10. The method of claim 8, wherein the step of securing the anchoring fasteners comprises:

providing an inflatable balloon;

expanding the inflatable balloon; and

deploying the anchoring fasteners with the inflatable balloon.

11. The method of claim 8, wherein the step of securing the anchoring fasteners comprises:

providing a retractable sheath, the retractable sheath disposed over the anchoring fasteners, the anchoring fasteners having an anchoring end and an attached end, the attached end being attached to the ring shell;

retracting the retractable sheath;

releasing the anchoring end of the anchoring fasteners; and

positioning the anchoring end of the anchoring fasteners into heart tissue.

12. The method of claim 8, wherein the step of injecting the polymer includes the steps of injecting the polymer through a fill tube, the fill tube being connected to the ring shell.

13. The method of claim 12 further comprising disconnecting the fill tube from the ring shell.

14. The method of claim 13 further comprising:

filling the ring shell with a fluid prior to injecting the polymer;

verifying the location of the ring shell via the fluid; and

removing the fluid from the ring shell prior to injecting the polymer.