Stentless support structure

• US 10,080,655 B2
• Filed: 09/30/2016
• Issued: 09/25/2018
• 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:
  US15/282,617
• Publication Number:
  US 20170020664A1
• Time in Patent Office: 725 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 method of implanting a prosthetic heart valve, comprising:

radially compressing a prosthetic heart valve to a compressed configuration, wherein the prosthetic heart valve comprises a support portion configured to anchor the prosthetic heart valve to a patient'"'"'s native valve and a leaflet-supporting structure;

delivering the compressed prosthetic heart valve to or near a patient'"'"'s native valve annulus;

positioning the leaflet-supporting structure of the prosthetic heart valve supraannularly to a patient'"'"'s aortic valve; and

,

expanding the prosthetic heart valve to an expanded configuration, wherein the diameter of the prosthetic heart valve in the expanded configuration is greater than the diameter of the prosthetic heart valve in the compressed configuration, and wherein in the expanded configuration at least a portion of the leaflet-supporting structure is drawn within a lumen of the support portion;

wherein expanding the prosthetic heart valve comprises;

pushing a distal segment of said support portion out of a delivery catheter, thereby allowing said distal segment to self-expand;

pushing a proximal segment of said support portion into distal segment.

2. The method according to claim 1, wherein the prosthetic heart valve includes a one-piece prosthetic heart valve frame.

3. The method according to claim 1, wherein expanding the prosthetic heart valve effectively anchors the prosthetic heart valve without suturing the valve to the native valve.

4. The method of claim 1 further comprising:

observing said prosthetic heart valve function to control the flow of blood prior to releasing said prosthetic heart valve.

5. The method of claim 1 wherein expanding the prosthetic heart valve to an expanded configuration comprises causing said support portion to fold in on itself, thereby shortening said support portion and increasing a thickness and radial strength of said support portion.

6. The method of claim 1 wherein said step of pushing a proximal segment of said support portion into said distal segment, results in a portion of said proximal segment to remain outside of said distal segment, such that said leaflet-supporting structure is axially spaced from said distal segment when expanded.

7. The method of claim 1 wherein said step of expanding the prosthetic heart valve to an expanded configuration results in said support portion to form at least one flared end, said flared end assisting in anchoring said prosthetic heart valve to the native valve without suturing.

8. The method of claim 1 wherein delivering the compressed prosthetic heart valve to or near a patient'"'"'s native valve annulus comprises percutaneously delivering said compressed prosthetic heart valve via a delivery catheter.