Leaflet stitching backer

• US 10,231,829 B2
• Filed: 04/25/2017
• Issued: 03/19/2019
• Est. Priority Date: 05/04/2016
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Backus, Andrew J. H., Pham, Anh Thu
• Primary Examiner(s): Ganesan, Suba
• Application Number:
  US15/496,600
• Publication Number:
  US 20170319335A1
• Time in Patent Office: 693 Days
• 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 2/243 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 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A replacement heart valve post and leaflet assembly may include at least a first post member including a body portion, a cantilevered leg portion, and a hinge portion configured to connect the body portion and the cantilevered leg portion and one or more leaflets. The cantilevered leg portion may comprise a longitudinally extending slot defined therein. At least a portion of a leaflet may extend through the slot. A backing element may be positioned over a portion of a leaflet such that the leaflet is secured between the cantilevered leg portion and the backing element.

Claims

1. A replacement heart valve post and leaflet assembly, the assembly comprising:

a first post member including a body portion, a cantilevered leg portion, and a hinge portion configured to connect the body portion and the cantilevered leg portion, wherein the cantilevered leg portion comprises a longitudinally extending slot defined therein;

a first leaflet comprising at least a first sleeve, a second sleeve, and a body portion, wherein the first sleeve of the first leaflet extends through the slot of the cantilevered leg portion of the first post member and rests against an inner surface thereof;

a second leaflet comprising at least a first sleeve, a second sleeve, and a body portion, wherein the first sleeve of the second leaflet extends through the slot of the cantilevered leg portion of the first post member and rests against an inner surface thereof; and

a backing element positioned over the first sleeve of the first leaflet and the first sleeve of the second leaflet such that the first sleeves are positioned between the backing element and the cantilevered leg portion of the first post member,

further comprising a first plurality of apertures extending longitudinally along a first side of the backing element and a second plurality of apertures extending longitudinally along a second side of the backing element.

2. The replacement heart valve post and leaflet assembly of claim 1, wherein the first sleeves of the first and second leaflets extend laterally beyond a lateral edge of the cantilevered leg portion of the first post member.

3. The replacement heart valve post and leaflet assembly of claim 1, wherein the backing element extends laterally beyond at least one lateral edge of the cantilevered leg portion of the first post member.

4. The replacement heart valve post and leaflet assembly of claim 1, wherein the backing element is sutured to at least one of the first sleeves of the first and second leaflets.

5. The replacement heart valve post and leaflet assembly of claim 1, wherein the backing element is sutured to both of the first sleeves of the first and second leaflets.

6. The replacement heart valve post and leaflet assembly of claim 1, wherein the first sleeves of the first and second leaflets are free from direct fixation to the cantilevered leg portion of the first post member.

7. The replacement heart valve post and leaflet assembly claim 1, wherein the backing element comprises a polymeric material.

8. The replacement heart valve post and leaflet assembly claim 1, wherein the backing element comprises a metallic material.

9. The replacement heart valve post and leaflet assembly of claim 1, further comprising a hole formed in the backing element adjacent a top edge thereof.

10. The replacement heart valve post and leaflet assembly of claim 9, wherein the backing element is sutured to the cantilevered leg portion of the first post member through the hole.

11. The replacement heart valve post and leaflet assembly of claim 1, wherein the backing element is configured to prevent the first sleeves of the first and second leaflets from passing through the longitudinally extending slot of the first post member.

12. A replacement heart valve post and leaflet assembly, the assembly comprising:

a first post member including a body portion, a cantilevered leg portion, and a hinge portion configured to connect the body portion and the cantilevered leg portion, wherein the cantilevered leg portion comprises a longitudinally extending slot defined therein;

a first leaflet comprising at least a first sleeve, a second sleeve, and a body portion, wherein the first sleeve of the first leaflet extends through the slot of the cantilevered leg portion of the first post member and rests against an inner surface thereof;

a second leaflet comprising at least a first sleeve, a second sleeve, and a body portion, wherein the first sleeve of the second leaflet extends through the slot of the cantilevered leg portion of the first post member and rests against an inner surface thereof; and

a backing element comprising a first plurality of apertures extending longitudinally along a first edge thereof and a second plurality of apertures extending longitudinally along a second edge thereof, the backing element positioned over the first sleeve of the first leaflet and the first sleeve of the second leaflet such that the first sleeves are positioned between the backing element and the cantilevered leg portion of the first post member and the backing element is configured to prevent the first sleeves of the first and second leaflets from passing through the longitudinally extending slot of the first post member.

13. The replacement heart valve post and leaflet assembly of claim 12, wherein the first sleeves of the first and second leaflets extend laterally beyond a lateral edge of the cantilevered leg portion of the first post member.

14. The replacement heart valve post and leaflet assembly of claim 12, wherein the backing element extends laterally beyond at least one lateral edge of the cantilevered leg portion of the first post member.

15. The replacement heart valve post and leaflet assembly of claim 12, wherein the backing element is sutured to at least one of the first sleeves of the first and second leaflets through at least one of the first or second plurality of apertures.

16. The replacement heart valve post and leaflet assembly of claim 12, wherein the first sleeves of the first and second leaflets are free from a direct coupling to the cantilevered leg portion of the first post member.

17. The replacement heart valve post and leaflet assembly of claim 12, further comprising a hole formed in the backing element adjacent a top edge thereof.

18. The replacement heart valve post and leaflet assembly of claim 17, wherein the backing element is sutured to the cantilevered leg portion of the first post member through the hole.

19. A replacement heart valve post and leaflet assembly, the assembly comprising:

a first post member including a body portion, a cantilevered leg portion, and a hinge portion configured to connect the body portion and the cantilevered leg portion, wherein the cantilevered leg portion comprises a longitudinally extending slot defined therein;

a second post member including a body portion, a cantilevered leg portion, and a hinge portion configured to connect the body portion and the cantilevered leg portion, wherein the cantilevered leg portion comprises a longitudinally extending slot defined therein;

a third post member including a body portion, a cantilevered leg portion, and a hinge portion configured to connect the body portion and the cantilevered leg portion, wherein the cantilevered leg portion comprises a longitudinally extending slot defined therein;

a first leaflet comprising at least a first sleeve, a second sleeve, and a body portion, wherein the first sleeve of the first leaflet extends through the slot of the cantilevered leg portion of the first post member and rests against an inner surface thereof and the second sleeve of the first leaflet extends through the slot of the cantilevered leg portion of the second post member and rests against an inner surface thereof;

a second leaflet comprising at least a first sleeve, a second sleeve, and a body portion, wherein the first sleeve of the second leaflet extends through the slot of the cantilevered leg portion of the first post member and rests against an inner surface thereof and the second sleeve of the second leaflet extends through the slot of the cantilevered leg portion of the third post member and rests against an inner surface thereof;

a third leaflet comprising at least a first sleeve, a second sleeve, and a body portion, wherein the first sleeve of the third leaflet extends through the slot of the cantilevered leg portion of the second post member and rests against an inner surface thereof and the second sleeve of the third leaflet extends through the slot of the cantilevered leg portion of the third post member and rests against an inner surface thereof;

a first backing element positioned over the first sleeve of the first leaflet and the first sleeve of the second leaflet such that the first sleeve of the first leaflet and the first sleeve of the second leaflet are positioned between the backing element and the cantilevered leg portion of the first post member;

a second backing element positioned over the second sleeve of the first leaflet and the first sleeve of the third leaflet such that the second sleeve of the first leaflet and the first sleeve of the third leaflet are positioned between the backing element and the cantilevered leg portion of the second post member; and

a third backing element positioned over the second sleeve of the second leaflet and the second sleeve of the third leaflet such that the second sleeve of the second leaflet and the second sleeve of the third leaflet are positioned between the backing element and the cantilevered leg portion of the third post member,

further comprising a first plurality of apertures extending longitudinally along a first side of the backing elements and a second plurality of apertures extending longitudinally along a second side of the backing elements.