Stentless support structure

• US 10,646,337 B2
• Filed: 10/09/2017
• Issued: 05/12/2020
• Est. Priority Date: 05/27/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: HLT, Inc. (Bracco SPA)
• Inventors: Thill, Gary A., Wilson, Robert Foster, Gainor, John P., Banick, Christopher M.
• Primary Examiner(s): Prone, Christopher D.
• Assistant Examiner(s): Shipmon, Tiffany P
• Application Number:
  US15/728,006
• Publication Number:
  US 20180028312A1
• Time in Patent Office: 946 Days
• 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 for delivering 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 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.

2. The method of claim 1 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.

3. The method of claim 1 wherein said preformed folds are axially displaced such that, upon inversion, at least a part of the support structure becomes three-ply.

4. The method of claim 1 wherein acting on said distal portion with said inversion mechanism in said direction opposite of said direction of said pushing until said support structure folds into itself along said preformed fold comprises folding said distal portion into a proximal portion.

5. The method of claim 4 wherein folding said proximal portion is located at a target location.

6. The method of claim 1 wherein acting on said distal portion with an inversion mechanism comprises acting on said distal portion with at least one pull-wire.

7. The method of claim 6 wherein said pull-wire passes through at least a portion of said support structure.

8. The method of claim 1 wherein pushing at least said distal portion of said support structure comprises pushing at least said distal portion of a braided support structure.

9. The method of claim 1 wherein pushing at least a distal portion of said support structure having said preformed fold formed therein out of said delivery catheter comprises preventing proximal movement of said support structure while proximally retracting said delivery catheter.

10. The method of claim 1 further comprising the step of releasing said support structure from said delivery catheter.

11. The method of claim 10 further comprising the step of verifying a functionality of said support structure prior to said step of releasing said support structure from said delivery catheter.