Stent Seals and Methods for Sealing an Expandable Stent

• US 20140128964A1
• Filed: 11/07/2013
• Published: 05/08/2014
• Est. Priority Date: 11/08/2012
• Status: Abandoned Application

• Current Assignee: Symetis SA (Boston Scientific Corporation)
• Original Assignee: Symetis SA (Boston Scientific Corporation)
• Inventors: Delaloye, Stephane
• Application Number:
  US14/074,505
• Publication Number:
  US 20140128964A1
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: Y10T 29/49412 with assembly, disassembly or composite article making

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 cuff containing material that swells when contacted by blood. A piercing tool may be included and used to permit a user to puncture the cuff prior to introduction into a patient'"'"'s body. In some embodiments, the cuff has an integral tubular structure configured to withstand balloon expansion of the stent-valve during or after implantation.

Claims

1. A stent-valve for transcatheter implantation to replace a cardiac valve, the stent-valve being compressible to a compressed configuration for delivery, and expandable to an operative state for implantation, the stent-valve comprising a stent, a plurality of leaflets defining a prosthetic valve, and a seal for sealing against surrounding tissue, wherein the seal comprises:

a hollow cuff arranged to extend in a circumferential direction substantially around the stent and containing swellable material that swells when contacted by blood to distend the hollow cuff, the hollow cuff comprising an integral tubular structure.

2. The stent-valve of claim 1, wherein the hollow cuff comprises a tubular extrusion or blow molded tubing.

4. The stent-valve of claim 1, wherein the hollow cuff defines a hollow toroid shape around the stent, the toroid shape being closed-loop or split or helical.

5. The stent-valve of claim 4, wherein the hollow cuff comprises an elongate tubular member bent to define the toroid shape.

6. The stent-valve of claim 5, wherein the ends of the elongate tubular member are joined together to define a closed-loop toroid shape.

7. The stent-valve of any preceding claim, wherein the hollow cuff comprises a tubular segment from a valvuloplasty balloon.

8. The stent-valve of claim 1, wherein the hollow cuff comprises a laminate of (i) plastics film and (ii) a diffusion barrier layer to obstruct diffusion of liquids from outside the hollow cuff to the hollow interior, the diffusion barrier layer comprising metal or a metal compound.

10. The stent-valve of claim 8, wherein the diffusion barrier layer is a plasma vapor deposited layer.

3. A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed configuration for delivery, and expandable to an operative state for implantation, the stent-valve comprising a stent, a plurality of leaflets defining a prosthetic valve, and a seal for sealing against surrounding tissue, wherein the seal comprises:

a hollow cuff arranged to extend in a circumferential direction substantially around the stent and containing swellable material that swells when contacted by blood to distend the hollow cuff, wherein the hollow cuff comprises a tubular extrusion or blow molded tubing.

9. A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed configuration for delivery, and expandable to an operative state for implantation, the stent-valve comprising a stent, a plurality of leaflets defining a prosthetic valve, and a seal for sealing against surrounding tissue, wherein the external seal comprises:

a hollow cuff arranged to extend in a circumferential direction substantially around the stent and containing swellable material that swells when contacted by blood to distend the hollow cuff, comprising a laminate of (i) plastics film and (ii) a diffusion barrier layer to obstruct diffusion of liquids from outside the hollow cuff to the hollow interior, the diffusion barrier layer comprising a layer comprising metal or a metal compound.

11. The stent-valve of claim 9, wherein the diffusion barrier player is formed (i) on an interior face of the cuff, or (ii) as a non-surface layer of the laminate.

12. The stent-valve of claim 9, wherein the diffusion barrier layer has a thickness of less than 100 nm, optionally less than 50 nm, optionally less than 10 nm.

13. The stent-valve of claim 9, wherein the diffusion barrier layer remains in position on the stent-valve when the valve is implanted.

14. The stent-valve of claim 9, wherein the hollow cuff is configured to withstand post-implantation balloon expansion of the stent-valve against a calcified anatomy without substantial loss of structural integrity of the hollow cuff.

16. The stent-valve of claim 9, wherein the cuff is configured to be manually pierceable at one or more points to define liquid admitting punctures permitting liquid entry into the cuff.

17. The stent-valve of claim 9, wherein the cuff has one or more liquid admitting punctures made therein, prior to introduction of the stent-valve into the body of a patient, for admitting liquid into the seal.

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