Stent-valves for valve replacement and associated methods and systems for surgery

• US 10,716,662 B2
• Filed: 04/12/2013
• Issued: 07/21/2020
• Est. Priority Date: 08/21/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Limited (Boston Scientific Corporation)
• Inventors: Delaloye, Stephane, Hefti, Jean-Luc, Delaloye, Serge
• Primary Examiner(s): Ganesan, Suba
• Application Number:
  US13/861,782
• Publication Number:
  US 20140039614A1
• Time in Patent Office: 2,657 Days
• Field of Search: 623 21, 623 212, 623 214, 623 217, 623 218, 623 236, 623 238, 623 115, 623 124, 623 126, 623 136, 623 137
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2250/0018 differing in elasticity, stiffness or compressibility

Abstract

A stent-valve having a valve component and a stent component for housing the valve component, as well as associated methods and systems for delivery of the stent-valve via minimally-invasive surgery. The stent-valve can be configurable between two or more configurations to assist in delivery of the stent-valve to an implantation site of a patient.

Claims

1. A replacement valve for use within a human body comprising:

a valve component comprising an outer surface covered at least partially with a fabric skirt configured to extend below the valve component; and

a stent component for housing the valve component,

wherein the stent component and valve components are configurable into at least a collapsed configuration for percutaneous delivery and an expanded configuration after implantation, a free edge of the fabric skirt wraps a bottom portion of the stent component and is affixed to the stent component via a plurality of sutures; and

at least a portion of the fibers of the fabric skirt are oriented at substantially 45 degrees with respect to a longitudinal axis of the valve component in the expanded configuration.

2. The replacement valve of claim 1, wherein the free edge of the skirt comprises at least one cut oriented in a direction of a longitudinal axis of the stent component.

3. The replacement valve of claim 2, wherein a plurality of cuts are made along the free edge between sutures of the plurality of sutures of the free edge to the stent component.

4. The replacement valve of claim 3, wherein the free edge includes a plurality of flexible flaps around a circumference of the stent component.

5. The replacement valve of claim 4, wherein the plurality of flexible flaps is configured to at least one of promote blood clotting to establish a blood barrier and assist the skirt in conforming to the stent component.

6. The replacement valve of claim 1, wherein the bottom portion of the stent component has an undulating lower edge, and wherein the free edge of the skirt that wraps the bottom portion is affixed to the stent component at one or more locations above the undulating lower edge.

7. The replacement valve of claim 6, wherein the bottom portion of the stent component is defined by multiple installations of a strut having an apex, wherein there are at least ten installations.

8. The replacement valve of claim 1, wherein the skirt comprises first and second separate pieces of fabric joined by a plurality of sutures.

9. A replacement valve for use within a human body comprising:

a valve component comprising an outer surface covered at least partially with a fabric skirt configured to extend below the valve component; and

a stent component for housing the valve component,

wherein the stent component and the valve component are configurable into at least a collapsed configuration for percutaneous delivery and an expanded configuration after implantation, a free edge of the fabric skirt wraps a bottom portion of the stent component and affixed to the stent component via a plurality of sutures; and

at least a portion the fabric skirt includes fibers which are oriented substantially plus 45 degrees with respect to a longitudinal axis of the valve component and fibers which are oriented substantially minus 45 degrees with respect to a longitudinal axis of the valve component in the expanded configuration.

10. The replacement valve of claim 9, wherein the free edge of the fabric skirt comprises at least one cut oriented in a direction of a longitudinal axis of the stent component.

11. The replacement valve of claim 10, wherein a plurality of cuts are made along the free edge between sutures of the plurality of sutures of the free edge to the stent component.

12. The replacement valve of claim 11, wherein the free edge includes a plurality of flexible flaps around a circumference of the stent component.

13. The replacement valve of claim 12, wherein the plurality of flexible flaps are configured to promote at least one of blood clotting to establish a blood barrier and to assist the fabric skirt in conforming to the stent component.

14. The replacement valve of claim 10, wherein the bottom portion of the stent component has an undulating lower edge, and wherein the free edge of the fabric skirt wraps the bottom portion and is affixed to the stent component at one or more locations above the undulating lower edge.

15. The replacement valve of claim 14, wherein the bottom portion of the stent component is defined by multiple installations of a first strut having an apex and a second strut located within the first strut,

wherein the end of the second struts connected to the end of the first strut, which multiple installations include at least ten installations.

16. The replacement valve of claim 9, wherein the fabric skirt comprises a first separate piece of fabric and a second separate piece of fabric joined by a plurality of sutures.

17. The replacement valve of claim 9, further comprising a strip having a first portion having a first width and a second portion having a second width extending longitudinally from the first portion, wherein the first portion having a first width includes a slit transverse to a longitudinal direction of the strip, the slit having transverse extents within the first portion which are less than the first width and greater than the second width.

18. A replacement valve for use within a human body comprising:

a valve component comprising an outer surface covered at least partially with a fabric reinforcement;

a stent component housing the valve component therein; and

a fabric skirt;

wherein the stent component and valve components are configurable into at least a collapsed configuration for percutaneous delivery and an expanded configuration after implantation;

wherein at least a portion of the fabric skirt is disposed on an outer surface of the stent component and affixed to the stent component via at least one suture; and

wherein at least a portion of the fibers of the fabric reinforcement are oriented at substantially 45 degrees with respect to a longitudinal axis of the valve component in the expanded configuration.

19. The replacement valve of claim 18, wherein the fabric reinforcement is affixed to the stent component via at least one suture.

20. The replacement valve of claim 18, wherein the fabric skirt is directly connected to the fabric reinforcement.