PROSTHESIS SEALS AND METHODS FOR SEALING AN EXPANDABLE PROSTHESIS

• US 20160022444A1
• Filed: 03/13/2014
• Published: 01/28/2016
• 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, Stphane, Essinger, Jacques, Hefti, Jean-Luc, Mantanus, Luc, Lombardi, Fabien, Biadillah, Youssef, Flaction, Lionel, Wanakoht, Yutit
• Granted Patent: US 10,420,658 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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. A kit comprising:

a stent-valve; and

a seal comprising swellable material that swells in response to contact with blood;

wherein at least a component of the seal is provided as a separate item from the stent-valve, and is mountable to and/or introducible to the stent-valve.

2. The kit of claim 1, wherein the component of the seal is mountable to the stent-valve prior to introduction of the stent-valve into a patient'"'"'s body.

3. The kit of claim 1, further comprising a first container compartment containing the stent-valve immersed in liquid.

4. The kit of claim 3, further comprising a second container compartment containing the at least a component of the seal in a dry environment.

5. The kit of claim 4, wherein the second container compartment is outside the first container compartment.

6. An apparatus comprising:

a stent-valve comprising an accommodation region for accommodating a seal component to form a seal around the exterior of the stent-valve; and

a 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.

7. The apparatus of claim 6, wherein the accommodation region comprises a substantially continuous or discontinuous accommodation channel.

8. The apparatus of claim 7, wherein a loading filament is provided within the accommodation channel.

9. The apparatus of claim 6, wherein the seal component comprises a tube surrounding the swellable material.

10. The apparatus of claim 6, wherein the seal component comprises exposed swellable material.

11. The apparatus of claim 6, wherein the accommodation defines a cuff for confining the swellable material in use.

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

13-18. -18. (canceled)

19. A method comprising:

(a) providing a stent-valve contained in a storage liquid;

(b) rinsing the stent-valve to substantially remove the storage liquid from the stent-valve;

(c) after rinsing, introducing and/or mounting to the stent-valve at least a component of a seal for the stent-valve, the seal comprising swellable material that swells in response to contact with blood or a blood component.

20. The method of claim 19, wherein the step (c) comprises using a loading filament to draw a seal component into an accommodation channel of the stent-valve.

21. The method of claim 19, wherein the step (c) is performed while the stent-valve is outside a patient'"'"'s body.

22. The method of claim 19, wherein the method is performed as part of a pre-implantation preparation process.

23. A method comprising:

providing a stent-valve with an accommodation region for at least a component of a seal; and

providing at least a component of the seal, the component comprising swellable material that swells in response to contact with blood or a blood component; and

mounting the seal component at the accommodation region of the stent-valve.

24. The method of claim 23, wherein the accommodation region comprises an accommodation channel, and wherein the step of mounting comprises sliding the seal component into the accommodation channel.

25. The method of claim 24, wherein the step of providing the stent-valve comprises providing a loading filament within the accommodation channel, and wherein the step of sliding comprises using the loading filament to slide the seal component into the channel.

26-93. -93. (canceled)