Stentless support structure

• US 10,022,221 B2
• Filed: 07/01/2015
• Issued: 07/17/2018
• 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:
  US14/789,875
• Publication Number:
  US 20160095702A1
• Time in Patent Office: 1,112 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 of delivering a support structure comprising:

navigating to a target location, a support structure having two unfolded axially-spaced preformed folds defining a distal portion, a middle portion, and a proximal portion;

positioning said support structure within the target location;

allowing said two unfolded axially-spaced preformed folds to assume folded configurations, thereby causing said middle portion to invert such that said distal portion is pulled into said proximal portion.

2. The method of claim 1 wherein allowing said two unfolded axially-spaced preformed folds to assume folded configurations comprises pulling said distal portion toward said proximal portion.

3. The method of claim 1 wherein navigating to 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 1 wherein allowing said two unfolded axially-spaced preformed folds to assume folded configurations, thereby causing said middle portion to invert such that said distal portion is pulled into said proximal portion comprises allowing said two unfolded axially-spaced preformed folds to assume folded configurations, thereby causing said middle portion to invert such that said distal portion is pulled 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 allowing said two unfolded axially-spaced preformed folds to assume folded configurations comprises preventing proximal movement of said support structure with a catheter while pulling proximally with a pull wire.

8. The method of claim 7 wherein preventing proximal movement of said support structure with a catheter while pulling proximally 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 system for implanting an invertible support structure comprising:

an implantable valve assembly including a proximal portion, a middle portion, and a distal portion, the distal portion at least partially comprising a valve mechanism;

a delivery catheter configured to contain the implantable valve assembly in an unfolded, elongated state;

an inversion mechanism that causes the middle portion to inwardly invert, thereby drawing the distal portion into the proximal portion.

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

11. The system of claim 9 wherein said implantable valve assembly comprises a mesh tube constructed of memory metal.

12. The system of claim 11 wherein said inversion mechanism comprises a preformed fold in said mesh tube that regains a folded state when released from said delivery catheter.

13. The delivery device of claim 11 wherein said inversion mechanism is releasably connected to said mesh tube distal of a preformed fold formed in said support structure.

14. The delivery device of claim 13 wherein said inversion mechanism is releasably connected to a distal end of said mesh tube.

15. The delivery device of claim 9 wherein said valve mechanism comprises a wireform having a distal end and a proximal end, the proximal end attached to a distal end of the middle portion.

16. The delivery device of claim 11 wherein said mesh tube comprises two axially spaced preformed folds.

17. The delivery device of claim 16 wherein said inversion mechanism is releasably connected to said mesh tube near a distal-most preformed fold.

18. The delivery device of claim 16 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.

19. A prosthetic valve assembly comprising:

a distal portion, a middle portion and a proximal portion;

said proximal portion separated from said middle portion by an inward-facing preformed fold;

said distal portion including a prosthetic valve;

wherein at least said proximal portion and said middle portion comprise a mesh tube constructed of memory metal;

wherein, when released, said inward-facing preformed fold resumes a folded configuration that draws said distal portion into said middle portion.

20. The prosthetic valve assembly of claim 19 wherein said distal portion comprises a distal end of said mesh tube and is separated from said proximal portion by an outward-facing preformed fold in said mesh tube that, when released, resumes a folded configuration that prevents said distal portion from inverting with said middle portion.