Stentless support structure

• US 9,089,423 B2
• Filed: 05/10/2011
• Issued: 07/28/2015
• Est. Priority Date: 05/10/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: HLT, Inc. (Bracco SPA)
• Inventors: Gainor, John, Thill, Gary A., Wilson, Robert Foster, Banick, Christopher M.
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US13/104,866
• Publication Number:
  US 20120065728A1
• Time in Patent Office: 1,540 Days
• Field of Search: 623/2.11
• US Class Current: 1/1
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0067 conical

Abstract

A stentless support structure capable of being at least partly assembled in situ. The support structure comprises a braided tube that is very flexible and, when elongated, becomes very long and very small in diameter, thereby being capable of placement within a small diameter catheter. The support structure is preferably constructed of one or more thin strands of a super-elastic or shape memory material such as Nitinol. When released from the catheter, the support structure folds itself into a longitudinally compact configuration. The support structure thus gains significant strength as the number of folds increase. This radial strength obviates the need for a support stent. The support structure may include attachment points for a prosthetic valve.

Claims

1. A method of delivering a support structure comprising:

providing a support structure having two axially-spaced preformed folds;

positioning said support structure within a target location;

folding a portion of said support structure between said preformed folds into itself;

wherein said folding is at least partially effected by acting on a distal portion of said support structure with a pull wire attached to said support structure near a more distal of said preformed folds while pushing on a proximal portion;

releasing said support structure from said pull wire by activating a release mechanism;

retracting said pull wire from within said support structure.

2. The method of claim 1 wherein folding said support structure into itself comprises folding said distal portion into said proximal portion.

3. The method of claim 1 wherein positioning said support structure within a target location comprises navigating a catheter containing said support structure through the apex of a heart, through the left ventricle and positioning a distal end of the catheter within or near the aortic valve of the heart.

4. The method of claim 1 wherein positioning said support structure within a target location comprises pushing said distal portion out of a delivery catheter distal of said target location.

5. The method of claim 4 wherein folding said support structure into itself comprises folding said distal portion into said proximal portion, said proximal portion being located at said target location.

6. The method of claim 1 wherein positioning said support structure within a target location comprises sliding a delivery catheter containing said support structure over a guidewire leading to said target location.

7. The method of claim 1 wherein said acting on a distal portion of said support structure with a pull wire while pushing on a proximal portion comprises preventing proximal movement of said support structure with a catheter while pulling proximally with said pull wire.

8. The method of claim 1 wherein acting on a distal portion of said support structure with a pull wire comprises acting on a distal portion of said support structure with a pull wire that passes through at least a portion of said support structure.

9. A delivery device for an invertible, implantable support structure comprising:

a delivery catheter configured to contain an invertible, implantable support structure in an unfolded, elongated state;

an inversion mechanism passing through said delivery catheter, at least partially through an interior of said invertible, implantable support structure, and releasably connected to said invertible, implantable support structure;

wherein said inversion mechanism is usable to initiate inversion of said invertible, implantable support structure during delivery by acting on a distal portion of said invertible, implantable support structure.

10. The delivery device of claim 9 wherein said inversion mechanism comprises a pull wire.

11. The delivery device of claim 9 wherein said inversion mechanism is releasably connected to said invertible, implantable support structure distal of a preformed fold formed in said invertible, implantable support structure.

12. The delivery device of claim 11 wherein said inversion mechanism is releasably connected to a distal end of said support structure.

13. The delivery device of claim 11 wherein said invertible, implantable support structure comprises two axially spaced preformed folds and said inversion mechanism is releasably connected to said invertible, implantable support structure near a distal-most preformed fold.

14. The delivery device of claim 13 wherein said preformed folds cause said invertible, implantable support structure to form a folded structure, upon inversion, having three plies in at some point along an axial length of said folded structure.

15. A method for initiating inversion of a support structure comprising:

pushing at least a distal portion of a support structure having a preformed fold formed therein out of a delivery catheter in an elongated, unfolded state, said distal portion being material at or distal of said preformed fold;

acting on said distal portion near said fold with an inversion mechanism in a direction opposite of a direction of said pushing until said support structure folds into itself along said preformed fold;

releasing said support structure from said inversion mechanism; and

retracting said inversion mechanism through an interior of said support structure.

16. The method of claim 15 wherein pushing at least a distal portion of a support structure having a preformed fold formed therein out of a delivery catheter in an elongated, unfolded state, said distal portion being material at or distal of said preformed fold comprises pushing at least a distal portion of a support structure having at least two preformed folds formed therein out of a delivery catheter in an elongated, unfolded state, said distal portion being material at or distal of a distal-most preformed fold.

17. The method of claim 15 wherein said preformed folds are axially displaced such that, upon inversion, at least a part of the support structure becomes three-ply.