Paravalvular leak occlusion device for self-expanding heart valves

• US 9,339,274 B2
• Filed: 03/12/2013
• Issued: 05/17/2016
• Est. Priority Date: 03/12/2013
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Dakin, Gregory James
• Primary Examiner(s): Miles, Jonathan W
• Assistant Examiner(s): Rwego, Kankindi
• Application Number:
  US13/797,513
• Publication Number:
  US 20140277425A1
• Time in Patent Office: 1,162 Days
• Field of Search: 604/96.01, 606/158, 606/191, 606/192, 606/194, 606/195, 606/198, 623 21- 235
• US Class Current: 1/1
• 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. A system for replacing native valve function, the system comprising:

a prosthetic heart valve having a collapsible and expandable stent forming cells, the stent having a plurality of sections including an annulus section, a transition section and an aortic section, and a valve assembly disposed in the stent; and

an 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 to a selected strut of the stent at a first position on the annulus section of the stent, and an expandable disk coupled to the second end of the body and passing through a cell of the stent to couple the occluder device to the stent at a second position in a section other than the annulus section.

2. The system of claim 1, wherein the disk is expandable from a collapsed configuration to a relaxed configuration.

3. The system of claim 2, wherein the disk in the relaxed configuration has a size larger than the size of at least some of the cells of the stent.

4. The system of claim 1, wherein the stent includes a plurality of struts and the fastener is coupleable to at least one of the plurality of the struts.

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

6. The system of claim 1, wherein the body has an elliptical longitudinal cross-section.

7. The system of claim 1, wherein the body includes a metal mesh and polyester fiber intertwined with the metal mesh.

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

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

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

11. The system of claim 1, further comprising:

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 device.

12. The system of claim 11, wherein the outer sheath is adapted to house the occluder device in a contracted configuration, and the outer sheath is sized to pass through a cell of the expandable stent.

13. The system of claim 1, wherein the annulus section has a first diameter, the transition section has a second diameter, the first diameter being different than the second diameter, and the expandable disk passes through the cell of the stent in the transition section.

14. The system of claim 1, wherein the expandable body is entirely disposed between the fastener and the expandable disk.

15. A system for replacing native valve function, the system comprising:

a prosthetic heart valve having a collapsible and expandable stent forming cells, and a valve assembly disposed in the stent; and

an occluder device comprising an expandable body having a first end and a second end, the first end and the second end being disposed on opposite ends of the body, a fastener extending in a first direction and coupled to the first end of the body, the fastener capable of latching onto an apex of a cell at a first position, and an expandable disk extending in a second direction, opposite the first direction, and coupled to the second end of the body, the expandable disk passing through a cell of the stent to couple the occluder device to the stent at a second position.

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

providing;

(1) a prosthetic heart valve having a collapsible and expandable stent forming cells, the stent having a plurality of sections including an annulus section, a transition section and an aortic section, and a valve assembly disposed in the stent; and

(2) an 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 to a selected strut of the stent at a first position on the annulus section of the stent, and an expandable disk coupled to the second end of the body and passing through a cell of the stent to couple the occluder device to the stent at a second position in a section other than the annulus section;

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 prosthetic heart valve to an outside of the heart prosthetic 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.

17. The method of claim 16, 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.

18. The method of claim 16, 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.

19. The method of claim 16, wherein delivering the occluder comprises disposing the occluder within a delivery system and advancing the delivery system into an interior of the prosthetic heart valve.

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