Repositionable endoluminal support structure and its applications

• US 9,259,314 B2
• Filed: 06/10/2011
• Issued: 02/16/2016
• 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:
  US13/158,232
• Publication Number:
  US 20110245918A1
• Time in Patent Office: 1,712 Days
• Field of Search: 623/1.11, 623 115- 116, 623 124- 126, 623 21- 219, 623/2.38
• US Class Current: 1/1
• 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 swivel 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 plurality of strut members wherein each of the plurality of strut members is directly connected to and pivots relative to a different strut member at each of three pivot joints and wherein none of the different strut members is directly connected to and pivots relative to one another, and wherein a portion of at least some strut members of the plurality of strut members comprises multiple layers; and

a prosthetic valve comprising a plurality of leaflets, wherein at least a portion of each of the plurality of leaflets is sandwiched between the multiple layers of at least one strut member of the plurality of strut members.

2. The implantable medical device of claim 1, wherein the plurality of strut members comprises strut openings.

3. The implantable medical device of claim 2, wherein the prosthetic valve is attached to the plurality of strut members using the strut openings.

4. An implantable medical device, comprising:

a plurality of struts, wherein a portion of at least some struts of the plurality of struts comprises multiple layers;

a plurality of pivoting joints between the plurality of struts, wherein the plurality of pivoting joints is greater in number than the plurality of struts; and

a prosthetic valve comprising a plurality of leaflets, wherein at least a portion of each of the plurality of leaflets is sandwiched between the multiple layers of at least one strut of the plurality of struts.

5. The implantable medical device of claim 4, wherein the plurality of pivoting joints comprises a first group of end joints, a second group of end joints, and a group of middle joints.

8. The implantable medical device of claim 4, wherein the plurality of struts comprises at least six strut members.

9. The implantable medical device of claim 4, wherein the plurality of struts comprises eighteen strut members.

6. An implantable medical device, comprising:

an implantable frame, comprising a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends, and a plurality of struts, wherein a portion of at least some struts of the plurality of struts comprises multiple layers, and wherein the implantable frame is configured to expand or collapse via rotation in response to application of first and second forces, wherein the first and second forces are parallel to the longitudinal axis; and

a prosthetic valve comprising a plurality of leaflets, wherein at least a portion of each of the plurality of leaflets is sandwiched between the multiple layers of at least one strut of the plurality of struts.

7. The implantable medical device of claim 6, wherein the one ply struts and multi ply struts form an uninterrupted loop configuration.

10. An implantable medical device, comprising:

a stent comprising a plurality of struts arranged as a chain of linkages forming a cylinder, wherein a portion of at least some struts of the plurality of struts comprises multiple layers, and wherein the cylinder is configured to expand in a radial fashion using a first force applied to compress one linkage of the stent and configured to collapse in a radial fashion using a second force applied to expand one linkage of the stent; and

a prosthetic valve comprising a plurality of leaflets, wherein at least a portion of each of the plurality of leaflets is sandwiched between the multiple layers of at least one strut of the plurality of struts.

11. The device of claim 10, wherein at least one of the first force or second force is a rotational force.