PARAVALVULAR LEAK OCCLUSION DEVICE FOR SELF-EXPANDING HEART VALVES

• US 20140277425A1
• Filed: 03/12/2013
• Published: 09/18/2014
• Est. Priority Date: 03/12/2013
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: AGA Medical Corporation (Abbott Laboratories)
• Inventors: Dakin, Gregory James
• Granted Patent: US 9,339,274 B2
• Time in Patent Office: Days
• US Class Current: 623/2.38
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2310/00011 Metals or alloys

Abstract

An occluder for sealing gaps between a medical device and adjacent body tissue includes an expandable body configured to fill the gaps between the medical device and the body tissue. The occluder includes a fastener at one end of the body and adapted to couple to a first end of the medical device, and an expandable disk at the other end of the body and adapted to couple to the medical device at a position spaced from the first end.

Claims

1. An occluder device for occluding a gap between a medical device and adjacent body tissue, the occluder device comprising:

an expandable body having a first end and a second end;

a fastener coupled to the first end of the body; and

an expandable disk coupled to the second end of the body.

2. The occluder device of claim 1, wherein the medical device is a prosthetic heart valve having a collapsible and expandable stent forming cells, and a valve assembly disposed in the stent for controlling the flow of blood through the stent.

3. The occluder device of claim 2, wherein the disk is expandable from a collapsed configuration to a relaxed configuration

4. The occluder device of claim 3, wherein the disk in the relaxed configuration has a size larger than the size of at least some of the cells of the stent.

5. The occluder device of claim 2, wherein the stent includes a plurality of struts and the fastener is coupleable to at least one of the plurality of the struts.

6. The occluder device of claim 1, wherein the body includes at least one of a metallic mesh or a shape-memory material.

7. The occluder device of claim 1, wherein the body has an elliptical longitudinal cross-section.

8. The occluder device of claim 1, wherein the body includes a metal mesh and polyester fiber intertwined with the metal mesh.

9. The occluder device of claim 1, wherein the fastener includes a loop for coupling to the medical device.

10. The occluder device of claim 1, wherein the disk includes at least one of a metallic mesh or a shape-memory material.

11. The occluder device of claim 1, further comprising a connector attached to the disk for coupling to a delivery device.

12. The occluder device of claim 1, wherein the body includes multiple segments, each segment being capable of independent radial expansion from the other segments.

13. A system for occluding a gap between a medical device and adjacent body tissue, the system comprising:

the occluder device of claim 1; and

a delivery system including an outer sheath, an inner wire disposed within and translatable with respect to the outer sheath, and a connector attached to the inner wire, the connector being configured to couple the inner wire to the expandable disk of the occluder.

14. The system of claim 13, wherein the outer sheath is adapted to house the occluder device in a contracted configuration, the medical device is a prosthetic heart valve having a collapsible and expandable stent forming cells and a valve assembly disposed in the stent for controlling the flow of blood through the stent, and the outer sheath is sized to pass through a cell of the expandable stent.

15. A method for occluding a gap between a prosthetic heart valve and adjacent body tissue, the method comprising:

delivering an occluder into an interior of the heart valve, the occluder including (i) an expandable body, (ii) a fastener coupled to one end of the body, and (iii) an expandable disk coupled to another end of the body;

advancing the occluder through a cell of the heart valve to an outside of the heart valve;

coupling the fastener to one end of the prosthetic heart valve; and

coupling the expandable disk to the prosthetic heart valve at a position spaced from the one end.

16. The method of claim 15, wherein the fastener is a loop and the step of coupling the fastener includes positioning the loop around an apex of a cell at the one end of the prosthetic heart valve.

17. The method of claim 15, wherein the disk in the relaxed configuration has a size larger than the size of at least one of the cells of the stent, and the step of coupling the disk includes disposing the disk on the outside of the at least one cell so that the disk cannot pass therethrough.

18. The method of claim 15, wherein delivering the occluder comprises disposing the occluder within a delivery system and advancing the delivery system into an interior of the heart valve.

19. The method of claim 18, further comprising the step of coupling the expandable disk to an inner wire of the delivery system.

20. The method of claim 19, further comprising the step of decoupling the expandable disk from the inner wire after coupling the expandable disk to the prosthetic heart valve.