Stentless support structure

• US 9,814,575 B2
• Filed: 10/03/2016
• Issued: 11/14/2017
• 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): Sweet, Thomas J
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US15/284,227
• Publication Number:
  US 20170020665A1
• Time in Patent Office: 407 Days
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0039 differing in diameter

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 prosthetic heart valve frame that is radially expandable from a compressed configuration to an expanded configuration, comprising:

a support portion adapted to anchor against a heart valve annulus, the support portion defining a lumen therethrough; and

a continuous annular wireform adapted to form at least one valve leaflet, wherein when the prosthetic valve frame is in the expanded configuration, at least a portion of the wireform is positioned within the lumen defined by the support portion, and wherein at least a part of the wireform is configured to undergo flexion during pulsatile loading.

2. The prosthetic heart valve frame according to claim 1 wherein the wireform has commissural points separated by arcuate portions and wherein in the expanded configuration, at least part of each of the arcuate portions are positioned inside the lumen of the support.

3. The prosthetic heart valve frame according to claim 2, wherein in the compressed configuration, the arcuate portions are configured to be spaced apart from the support portion along a longitudinal direction defined by the lumen of the support portion.

4. The prosthetic heart valve frame according to claim 1, wherein an inflow end of the support portion is flared outward in the expanded configuration, the inflow end being opposite the wireform.

5. The prosthetic heart valve frame of claim 1 wherein said wireform portion configured to undergo flexion during pulsatile loading facilitates natural and efficient opening and closing of the at least one valve leaflet.

6. The prosthetic heart valve frame of claim 2 wherein said arcuate portions are attached to an inside surface of the support portion.

7. The prosthetic heart valve frame of claim 2 wherein said arcuate portions are attached to an outside surface of said support portion, when said support portion is in said compressed configuration.

8. The prosthetic heart valve frame of claim 1 wherein said support portion comprises a mesh.

9. The prosthetic heart valve frame of claim 8 wherein said support portion folds in on itself when expanding from said compressed configuration.

10. A prosthetic heart valve frame that radially expands from a delivery configuration to deployed configuration, comprising:

a support portion adapted to anchor against a heart valve annulus, the support portion defining a lumen therethrough; and

a continuous annular wireform adapted to form at least one valve leaflet, wherein when the prosthetic valve frame is in the deployed configuration, at least a portion of the wireform is pulled into the lumen defined by the support portion, and wherein at least a part of the wireform is configured to undergo flexion during pulsatile loading.

11. The prosthetic heart valve frame according to claim 10 wherein the wireform has commissural points separated by arcuate portions and wherein in the deployed configuration, at least part of each of the arcuate portions are positioned inside the lumen of the support.

12. The prosthetic heart valve frame according to claim 10, wherein in the delivery configuration the arcuate portions are configured to be spaced apart from the support portion along a longitudinal direction defined by the lumen of the support portion.

13. The prosthetic heart valve frame according to claim 10, wherein an inflow end of the support portion is flared outward in the deployed configuration, the inflow end being opposite the wireform.

14. The prosthetic heart valve frame of claim 10 wherein said wireform portion configured to undergo flexion during pulsatile loading facilitates natural and efficient opening and closing of the at least one valve leaflet.

15. The prosthetic heart valve frame of claim 10 wherein the support portion folds inward in the deployed configuration.

16. The prosthetic heart valve frame of claim 15 wherein the at least a portion of the wireform that is pulled into the lumen defined by the support portion is pulled into the lumen during the folding of the support portion.

17. A prosthetic heart valve frame that radially expands when released from a catheter comprising:

a support portion adapted to anchor against a heart valve annulus, the support portion defining a lumen therethrough; and

,

a continuous annular wireform adapted to form at least one valve leaflet;

wherein when the prosthetic valve frame is released from a catheter, at least a portion of the wireform is pulled into the lumen defined by the support portion due to an inversion of the support portion; and

,

wherein at least a part of the wireform is configured to undergo flexion during pulsatile loading.

18. The prosthetic heart valve frame according to claim 17, wherein an inflow end of the support portion flares outwardly when released from a catheter, the inflow end being opposite the wireform.

19. The prosthetic heart valve of claim 17 wherein said wireform portion configured to undergo flexion during pulsatile loading facilitates natural and efficient opening and closing of the at least one valve leaflet.

20. The prosthetic heart valve of claim 17 wherein said support portion comprises a mesh.