Repositionable endoluminal support structure and its applications

• US 8,685,080 B2
• Filed: 07/21/2009
• Issued: 04/01/2014
• 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): Pellegrino, Brian E.
• Application Number:
  US13/055,441
• Publication Number:
  US 20110288632A1
• Time in Patent Office: 1,715 Days
• Field of Search: 623/1.15, 623/1.16, 623 214- 219, 623/1.24, 623/17.15, 606/200
• US Class Current: 623/1.26
• 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 endo luminal support structure (10) includes strut members (11) interconnected by swivel joints (15) 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 (100) within a body lumen.

Claims

1. A support implantable within a biological lumen, comprising:

a plurality of elongated strut members interlinked by a plurality of swivel joints forming a tubular support structure having a longitudinal axis, wherein the swivel joints cooperate with the strut members such that the strut members are swivelable in a plane parallel to the longitudinal axis to adjustably define a shaped structure between a compressed orientation and an expanded orientation,

further comprising an actuator mechanism mounted to two swivel joints aligned on the same longitudinal axis and configured to expand the plurality of elongated strut members by decreasing distances between swivel joints aligned on the same longitudinal axis,

wherein the tubular support structure is incrementally and reversibly adjustable between the compressed and expanded orientations in response to force parallel to the longitudinal axis from the actuator mechanism,

further comprising a prosthetic valve coupled to the plurality of elongated strut members interlinked by a plurality of swivel joints,

wherein the prosthetic valve comprises;

a first structural valve member coupled to the strut members;

a second structural valve member rotatable relative to the first structural member; and

a plurality of pliable valve members connecting the first structural valve member with the second structural valve member such that rotation of the second structural valve member relative to the first structural valve member urges the pliable valve members between an open and a closed state.

2. The support of claim 1, wherein the rotation of the second structural valve member is responsive to the natural flow of a biological fluid.

3. A support implantable within a biological lumen, comprising:

a plurality of elongated strut members interlinked by a plurality of swivel joints forming a tubular support structure having a longitudinal axis, wherein the swivel joints cooperate with the strut members such that the strut members are swivelable in a plane parallel to the longitudinal axis to adjustably define a shaped structure between a compressed orientation and an expanded orientation,

further comprising an actuator mechanism mounted to two swivel joints aligned on the same longitudinal axis and configured to expand the plurality of elongated strut members by decreasing distances between swivel joints aligned on the same longitudinal axis,

wherein the tubular support structure is incrementally and reversibly adjustable between the compressed and expanded orientations in response to force parallel to the longitudinal axis from the actuator mechanism,

further comprising a prosthetic valve coupled to the plurality of elongated strut members interlinked by a plurality of swivel joints,

wherein the prosthetic valve includes a plurality of pliable valve leaflets having commissures at the intersection of two strut members.

4. A support implantable within a biological lumen, comprising:

a plurality of elongated strut members interlinked by a plurality of swivel joints forming a tubular support structure having a longitudinal axis, wherein the swivel joints cooperate with the strut members such that the strut members are swivelable in a plane parallel to the longitudinal axis to adjustably define a shaped structure between a compressed orientation and an expanded orientation,

further comprising an actuator mechanism mounted to two swivel joints aligned on the same longitudinal axis and configured to expand the plurality of elongated strut members by decreasing distances between swivel joints aligned on the same longitudinal axis,

wherein the tubular support structure is incrementally and reversibly adjustable between the compressed and expanded orientations in response to force parallel to the longitudinal axis from the actuator mechanism,

further comprising a prosthetic valve coupled to the plurality of elongated strut members interlinked by a plurality of swivel joints,

wherein the prosthetic valve includes a skirt material coupled to the strut members.

5. A method of fabricating a support implantable within a biological lumen, comprising:

interlinking a plurality of elongated strut members with a plurality of swivel joints at three locations of each elongated strut member, such that the swivel joints cooperate with the strut members to adjustably define a tubular shaped structure between a compressed orientation and an expanded orientation, wherein the tubular shaped structure comprises a longitudinal axis, and wherein the strut members are swivelable in a plane parallel to the longitudinal axis; and

coupling an adjustment mechanism to the strut members configured to exert a force to urge the strut members about the swivel joints within a range of motion, wherein the tubular shaped structure is incrementally and reversibly adjustable between the compressed and expanded orientations in response to force from the adjustment mechanism parallel to the longitudinal axis.

6. The method of claim 5 further comprising coupling a prosthetic valve to the strut members.

7. The method of claim 6, wherein at least one of the plurality of elongated strut members is a multi-ply strut, and wherein the prosthetic valve comprises a plurality of leaflets, and wherein coupling a prosthetic valve to the strut members comprises sandwiching a leaflet between a multi-ply strut.

8. A support implantable within a biological lumen, comprising:

a plurality of elongated strut members interlinked by a plurality of swivel joints forming a tubular support structure having a longitudinal axis, wherein the swivel joints cooperate with the strut members such that the strut members are swivelable in a plane parallel to the longitudinal axis to adjustably define a shaped structure between a compressed orientation and an expanded orientation,

further comprising an actuator mechanism mounted to two swivel joints aligned on the same longitudinal axis and configured to expand the plurality of elongated strut members by decreasing distances between swivel joints aligned on the same longitudinal axis,

wherein the tubular support structure is incrementally and reversibly adjustable between the compressed and expanded orientations in response to force parallel to the longitudinal axis from the actuator mechanism,

further comprising a prosthetic valve coupled to the plurality of elongated strut members interlinked by a plurality of swivel joints,

wherein at least one of the plurality of elongated strut members is a multi-ply strut, and wherein the prosthetic valve comprises a plurality of leaflets, and wherein at least one of leaflets is sandwiched between a multi-ply strut.