Prosthesis seals and methods for sealing an expandable prosthesis

• US 10,420,658 B2
• Filed: 03/13/2014
• Issued: 09/24/2019
• Est. Priority Date: 03/13/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Symetis SA (Boston Scientific Corporation)
• Inventors: Delaloye, Stephane, Essinger, Jacques, Hefti, Jean-Luc, Biadillah, Youssef, Mantanus, Luc, Lombardi, Fabien, Flaction, Lionel, Wanakoht, Yutit
• Primary Examiner(s): Woznicki, Jacqueline
• Application Number:
  US14/775,666
• Publication Number:
  US 20160022444A1
• Time in Patent Office: 2,021 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/0056 differing in wettability, e.g. in hydrophilic or hydrophobic behaviours
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

Embodiments of the present disclosure are related to devices and techniques for para-valve sealing of an expandable stent-valve implanted using a catheter. In some embodiments, a stent-valve is provided which comprises a seal sleeve/cuff containing material that swells when contacted by blood. A piercing tool may be included and used to permit a user to puncture the sleeve/cuff prior to introduction into a patient'"'"'s body. In some embodiments, the sleeve/cuff has an integral tubular structure configured to withstand balloon expansion of the stent-valve during or after implantation. In some embodiments, the seal is provided as a separate component from the stent-valve.

Claims

1. An apparatus configured for delivery from a delivery catheter, comprising:

a stent-valve disposable, in a compressed configuration, within the delivery catheter, the stent-valve comprising an accommodation region for accommodating a seal component to form a seal around the exterior of the stent-valve, and the stent-valve being expandable from the compressed configuration to an operative configuration after delivery from the delivery catheter;

the seal component comprising swellable material that swells in response to contact with blood or a blood component, the seal component being mountable and/or introducible to the accommodation region to form a combined assembly with the stent-valve, in the compressed configuration, prior to delivery of the stent-valve from the delivery catheter;

wherein the accommodation region comprises an accommodation channel configured to receive the seal component therein, the accommodation channel being attached to the exterior of the stent-valve; and

a loading filament slidably disposed within the accommodation channel along a predefined path extending circumferentially around the stent-valve, the loading filament being configured to circumferentially pull the seal component into the accommodation channel along the predefined path thereby forming the combined assembly;

wherein the combined assembly is disposed within the delivery catheter prior to delivery.

2. The apparatus of claim 1, wherein the accommodation channel is a continuous accommodation channel.

3. The apparatus of claim 1, wherein the seal component comprises a tube surrounding the swellable material.

4. The apparatus of claim 1, wherein the seal component comprises exposed swellable material.

5. The apparatus of claim 1, wherein the accommodation channel defines a cuff for confining the swellable material in use.

6. The apparatus of claim 1, further comprising an introducer tube for facilitating mounting or introduction of the seal component to the stent-valve.

7. The apparatus of claim 1, wherein the accommodation channel is a discontinuous accommodation channel.

8. The apparatus of claim 7, wherein the accommodation channel is formed by a series of spaced-apart loops disposed circumferentially about the stent-valve.

9. The apparatus of claim 1, wherein the stent-valve includes a stent having an inflow portion and an outflow portion each formed by a lattice structure of the stent, and a plurality of stabilization arches extending downstream from the outflow portion.

10. The apparatus of claim 9, wherein the inflow portion includes an extremity formed with a zig-zag shape comprising upstream apexes and downstream apexes;

wherein the accommodation region is disposed between the downstream apexes and the outflow portion.