Repositionable endoluminal support structure and its applications

• US 9,005,272 B2
• Filed: 05/19/2011
• Issued: 04/14/2015
• Est. Priority Date: 07/21/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Jenesis Surgical LLC
• Inventors: White, Jennifer K.
• Primary Examiner(s): Matthews, Howie
• Application Number:
  US13/111,855
• Publication Number:
  US 20110288629A1
• Time in Patent Office: 1,426 Days
• Field of Search: 623/1.11, 623 115- 116, 623 124- 126, 623 21- 219, 623/2.38
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2421 with non-pivoting rigid closure members
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An endoluminal support structure includes strut members interconnected by pivot joints to form a series of linked scissor mechanisms. The structure can be remotely actuated to compress or expand its shape by adjusting the scissor joints within a range of motion. In particular, the support structure can be repositioned within the body lumen or retrieved from the lumen. The support structure can be employed to introduce and support a prosthetic valve within a body lumen.

Claims

1. An implantable medical device, comprising:

a frame comprising a first opening, a second opening, and a longitudinal axis therebetween, and comprising a plurality of struts interconnected by a plurality of joints, wherein the joints comprise a rotation axis perpendicular to the longitudinal axis of the frame; and

an actuation mechanism coupled to the frame at two anchor points and configured to selectively actuate expansion and collapse of the frame by applying longitudinal forces to the two anchor points to move the two anchor points longitudinally relative to each other,

wherein the actuation mechanism is self-locking to maintain the frame at a desired diameter,

wherein the actuation mechanism comprises a rotational interface that comprises a rod and a first threaded mount, wherein the rod comprises a first helical thread, and the first threaded mount is configured to cooperate with the first helical thread, and

wherein the implantable medical device is configured to be inserted into a patient.

2. The implantable medical device of claim 1, wherein the actuation mechanism is fixedly attached to the frame.

3. The implantable medical device of claim 2, wherein the actuation mechanism is fixedly attached to an inner surface of the frame.

4. The implantable medical device of claim 1, wherein the actuation mechanism is configured to asymmetrically apply longitudinally oriented force along a circumference of the frame.

5. The implantable medical device of claim 4, wherein the longitudinally oriented force is applied to a single longitudinal region of the frame.

6. The implantable medical device of claim 5, wherein the frame is configured to circumferentially expand or collapse from the force applied along the single longitudinal region of the frame.

7. The implantable medical device of claim 1, wherein the actuation mechanism is configured to expand the frame when manipulated in a first direction and to collapse the frame when manipulated in a second direction.

8. The implantable medical device of claim 7, wherein the first direction and the second direction are opposite directions.

9. The implantable medical device of claim 1, wherein the rod further comprises a second helical thread configured with an opposite thread direction of the first helical thread.

10. The implantable medical device of claim 9, wherein the actuation mechanism comprises a second threaded mount configured to cooperate with the second helical thread.

11. The implantable medical device of claim 10, wherein the plurality of struts comprises first, second, third and fourth strut members.

12. The implantable medical device of claim 11, wherein the first threaded mount is coupled to the first and second strut members.

13. The implantable medical device of claim 12, wherein the second threaded mount is coupled to the third and fourth strut members, and wherein the first strut member articulates with the third strut member, and the second strut member articulates with the fourth strut member.

14. The implantable medical device of claim 1, wherein the rod further comprises a first end adjacent to the first helical thread, wherein the first end comprises a non-circular cross-sectional shape.

15. The implantable medical device of claim 1, wherein the first helical thread comprises a thread count of at least about 240 turns/inch.

16. The implantable medical device of claim 1, wherein the actuation mechanism is located along an inner surface of the frame.

17. The implantable medical device of claim 1, wherein each of the plurality of strut members articulates with three other strut members.

18. The implantable medical device of claim 1, wherein the plurality of joints comprises rivet members.

19. The implantable medical device of claim 18, wherein the rivet members are located in openings in the plurality of strut members.

20. The implantable medical device of claim 1, further comprising a leaflet valve attached to the frame.

21. The implantable medical device of claim 20, wherein the leaflet valve comprises pericardial tissue.