Transcatheter stent-valves

• US 10,258,464 B2
• Filed: 03/25/2013
• Issued: 04/16/2019
• Est. Priority Date: 03/22/2012
• 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
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Shipmon, Tiffany
• Application Number:
  US14/777,503
• Publication Number:
  US 20160038281A1
• Time in Patent Office: 2,213 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2210/0061 swellable
• 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 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation, the stent-valve comprising a stent, a plurality of leaflets for defining a prosthetic valve, an inner skirt, an outer skirt, and a paravalve seal for sealing against surrounding tissue. In some embodiments, the paravalve seal comprises material that swells in response to contact with blood. In some embodiments, the seal comprises a flap or pocket that is distensible in response to backpressure and/or paravalve back-flow of blood.

Claims

1. A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation, the stent-valve comprising:

a stent,

a plurality of leaflets for defining a prosthetic valve, and

a paravalve seal for sealing against surrounding tissue,

wherein the seal comprises a skirt, at least a first portion of which is captive with respect to the stent, and at least a second portion of which is free to deploy or float relative to the stent,

wherein the skirt is an outer skirt carried on an exterior of the stent, and wherein the stent-valve has an inlet end and an outlet end, wherein;

the stent-valve further comprises an inner skirt communicating with the leaflets and carried on an interior of the stent,

wherein;

the outer skirt is attached directly to the inner skirt at one or more attachment positions, said attachment positions spaced from an end of the outer skirt closest to the outlet end of the stent-valve, to obstruct leakage of blood between the inner skirt and outer skirt,

the first portion of the outer skirt extends outside the stent from the one or more attachment positions towards the inlet end of the stent-valve; and

the second portion of the outer skirt extends from the one or more attachment positions, outside the stent towards the outlet end of the stent-valve, whereby in use the second portion can distend outwardly to seal against surrounding tissue under backpressure or back-flow of blood.

2. The stent-valve of claim 1, wherein the second portion of the outer skirt forms a wall of a pocket, the pocket being open towards the outlet end of the stent-valve.

3. The stent-valve of claim 1, wherein the inner skirt extends further than the outer skirt towards the outlet end of the stent-valve.

4. The stent-valve of claim 1, wherein the outer skirt extends further than the inner skirt towards the inlet end of the stent-valve.

5. The stent-valve of claim 4, wherein the inner skirt extends further than the outer skirt towards the outlet end of the stent-valve.

6. The stent-valve of claim 1, further comprising one or more control attachments between the second skirt portion and the stent.

7. The stent-valve of claim 1, wherein the stent comprises:

a lower tubular portion;

an upper crown communicating with the lower tubular portion;

a plurality of upstanding commissural supports communicating with the lower tubular portion and upstanding relative to the upper crown portion; and

a plurality of stabilization arches communicating with the commissural supports.

8. A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation, the stent-valve comprising:

a stent,

a plurality of leaflets for defining a prosthetic valve, and

a paravalve seal for sealing against surrounding tissue,

wherein the seal comprises a skirt, at least a first portion of which is captive with respect to the stent, and at least a second portion of which is free to deploy or float relative to the stent,

wherein the skirt is an outer skirt carried on an exterior of the stent, and wherein the stent-valve has an inlet end and an outlet end, wherein;

the stent-valve further comprises an inner skirt communicating with the leaflets and carried on an interior of the stent,

wherein;

the outer skirt is attached directly to the inner skirt at one or more attachment positions, said attachment positions spaced from an end of the outer skirt closest to the outlet end of the stent-valve, to obstruct leakage of blood between the inner skirt and outer skirt,

the first portion of the outer skirt extends from the one or more attachment positions towards the inlet end of the stent-valve; and

the second portion of the outer skirt extends from the one or more attachment positions to the end of the outer skirt closest to the outlet end of the stent-valve, defining a wall of a pocket open towards the outlet end of the stent valve, whereby in use the second portion can distend outwardly to seal against surrounding tissue under back-pressure or back-flow of blood.

9. The stent-valve of claim 8, wherein the inner skirt extends further than the outer skirt towards the outlet end of the stent-valve.

10. The stent-valve of claim 8, wherein the outer skirt extends further than the inner skirt towards the inlet end of the stent-valve.

11. The stent-valve of claim 10, wherein the inner skirt extends further than the outer skirt towards the outlet end of the stent-valve.

12. The stent-valve of claim 8, further comprising one or more control attachments between the second skirt portion and the stent.

13. The stent-valve of claim 8, wherein the stent comprises:

a lower tubular portion;

an upper crown communicating with the lower tubular portion;

a plurality of upstanding commissural supports communicating with the lower tubular portion and upstanding relative to the upper crown portion; and

a plurality of stabilization arches communicating with the commissural supports.

14. A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation, the stent-valve comprising:

a stent,

a plurality of leaflets for defining a prosthetic valve, and

a paravalve seal for sealing against surrounding tissue,

wherein the seal comprises a skirt, at least a first portion of which is captive with respect to the stent, and at least a second portion of which is free to deploy or float relative to the stent,

wherein the skirt is an outer skirt carried on an exterior of the stent, and wherein the stent-valve has an inlet end and an outlet end, wherein;

the stent-valve further comprises an inner skirt communicating with the leaflets and carried on an interior of the stent, the inner skirt extending further than the outer skirt towards the outlet end of the stent valve,

wherein;

the outer skirt is attached directly to the inner skirt at one or more attachment positions, said attachment positions spaced from an end of the outer skirt closest to the outlet end of the stent-valve, to obstruct leakage of blood between the inner skirt and outer skirt,

the first portion of the outer skirt extends from the one or more attachment positions towards the inlet end of the stent-valve; and

the second portion of the outer skirt extends from the one or more attachment positions to the end of the outer skirt closest to the outlet end of the stent-valve, whereby in use the second portion can distend outwardly to seal against surrounding tissue under back-pressure or back-flow of blood.

15. The stent-valve of claim 14, wherein the outer skirt extends further than the inner skirt towards the inlet end of the stent-valve.

16. The stent-valve of claim 14, further comprising one or more control attachments between the second skirt portion and the stent.

17. The stent-valve of claim 14, wherein the stent comprises:

a lower tubular portion;

an upper crown communicating with the lower tubular portion;

a plurality of upstanding commissural supports communicating with the lower tubular portion and upstanding relative to the upper crown portion; and

a plurality of stabilization arches communicating with the commissural supports.

18. A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation, the stent-valve comprising:

a stent,

a plurality of leaflets for defining a prosthetic valve, and

a paravalve seal for sealing against surrounding tissue,

wherein the seal comprises a skirt, at least a first portion of which is captive with respect to the stent, and at least a second portion of which is free to deploy or float relative to the stent,

wherein the skirt is an outer skirt carried on an exterior of the stent, and wherein the stent-valve has an inlet end and an outlet end, wherein;

the stent-valve further comprises an inner skirt communicating with the leaflets and carried on an interior of the stent,

wherein;

the outer skirt extends further than the inner skirt towards the inlet end of the stent-valve, and is attached directly to the inner skirt at one or more attachment positions, said attachment positions spaced from an end of the outer skirt closest to the outlet end of the stent-valve, to obstruct leakage of blood between the inner skirt and outer skirt,

the first portion of the outer skirt extends from the one or more attachment positions towards the inlet end of the stent-valve; and

the second portion of the outer skirt extends from the one or more attachment positions to the end of the outer skirt closest to the outlet end of the stent-valve, whereby in use the second portion can distend outwardly to seal against surrounding tissue under back-pressure or back-flow of blood.

19. The stent-valve of claim 18, further comprising one or more control attachments between the second skirt portion and the stent.

20. The stent-valve of claim 18, wherein the stent comprises:

a lower tubular portion;

an upper crown communicating with the lower tubular portion;

a plurality of upstanding commissural supports communicating with the lower tubular portion and upstanding relative to the upper crown portion; and

a plurality of stabilization arches communicating with the commissural supports.