Stented prosthetic heart valve and methods for making

• US 9,232,994 B2
• Filed: 03/15/2013
• Issued: 01/12/2016
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Original Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Inventors: Miller, Noam
• Primary Examiner(s): Prone, Christopher D
• Assistant Examiner(s): Diop, Rokhaya
• Application Number:
  US13/833,436
• Publication Number:
  US 20140277418A1
• Time in Patent Office: 1,033 Days
• Field of Search: 623/1.26, 623/2.1, 623/2.12, 623/2.13, 623/2.14, 623/2.15, 623/2.16, 623/2.17, 623/2.18, 623/2.19, 623/23.7
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A stented prosthetic heart valve including a stent, a plurality of leaflets, and a coupling apparatus. The stent includes a plurality of struts combining to define a generally tubular body, with the struts forming strut segments. The leaflets are mounted to the stent, and include a leaflet provided as part of a first leaflet layer that further forms a tab region. The coupling apparatus is configured for connecting the first leaflet layer to the stent, and includes a backing layer, a guide plate, and a pin. The guide plate and the pin are formed apart from the stent. In this regard, a portion of the backing layer and the tab region are secured between the guide plate and the pin. Further, another portion of the backing layer is attached to at least one of the strut segments to mount the leaflet of the first leaflet layer to the stent.

Claims

1. A stented prosthetic valve comprising:

a stent including a plurality of struts combining to define a tubular body, the plurality of struts forming first and second strut segments;

a plurality of leaflets mounted to the stent, a first one of the leaflets being provided as part of a first leaflet layer having a first tab region; and

a first coupling apparatus for connecting the first leaflet layer to the stent, the first coupling apparatus including;

a first backing layer,

a guide plate apart from the stent,

a pin apart from the stent,

wherein a portion of the backing layer and the first tab region are captured between the guide plate and the pin;

wherein the backing layer is attached to at least one of the first and second strut segments to mount the first leaflet to the stent;

wherein the backing layer includes a base and a first flap projecting from the base, and further wherein the base abuts the first tab region at an interface established between the guide plate and the pin, and even further wherein the first flap projects from the interface and is wrapped about the first strut segment;

wherein the backing layer further includes a second flap projecting from the base, and further wherein the second flap is wrapped about the second strut segment.

2. The stented prosthetic valve of claim 1, wherein the backing layer is attached to a commissure region defined by the stent.

3. The stented prosthetic valve of claim 1, wherein the guide plate forms a passageway, and further wherein the first tab region and the backing layer extend through the passageway.

4. The prosthetic valve of claim 1, wherein the first tab region and the backing layer are frictionally held between the guide plate and the pin.

5. The prosthetic valve of claim 4, wherein the first coupling apparatus further includes a first suture affixing the guide plate to the support pin, the first suture being free of the stent, the first tab region and the backing layer.

6. The prosthetic valve of claim 1, wherein the first coupling apparatus further includes a second backing layer, and further wherein the first tab region is disposed between the first and second backing layers.

7. The prosthetic valve of claim 6, wherein the second backing layer includes a base and a first flap, and further wherein:

the first tab region is disposed between the base of the first backing layer and the base of the second backing layer;

and

the first flap of the second backing layer is wrapped about a third strut segment.

8. The prosthetic valve of claim 7, wherein the first and second backing layers each further include a second flap projecting from the corresponding base, and further wherein

the second flap of the second backing layer is wrapped about a fourth strut segment.

9. The prosthetic valve of claim 1, wherein the plurality of leaflets further includes a second leaflet provided as part of a second leaflet layer having a first tab region, and the first coupling apparatus further includes a second backing layer, the backing layers each including a base and a flap, and further wherein the first tab region of the first and second leaflet layers are disposed between the base of the first backing layer and the base of the second backing layer.

10. The prosthetic valve of claim 9, wherein the guide plate forms a passageway, and further wherein the first tab regions and the bases collectively define a tongue extending through the passageway, including the first backing layer abutting the first leaflet layer, the second leaflet layer abutting the first leaflet layer opposite the first backing layer, and the second backing layer abutting the second leaflet layer opposite the first leaflet layer.

11. The prosthetic valve of claim 10, wherein the pin is disposed between the first and second leaflet layers adjacent the guide plate.

12. The prosthetic valve of claim 11, wherein the guide plate is connected to the pin to frictionally secure the backing layers and the leaflet layers between the guide plate and the support pin.

13. The prosthetic valve of claim 9, wherein the plurality of leaflets further includes a third leaflet provided as part of a third leaflet layer having a first tab region, wherein each of the first, second and third leaflet layers each including a second tab region opposite the corresponding first tab region, the prosthetic valve further including second and third coupling apparatuses each including a backing layer, and further wherein:

the first coupling apparatus connects the first tab region of the first leaflet layer and the first tab region of the second leaflet layer to the stent, including a flap of the backing layer of the first coupling apparatus wrapped about a first strut segment;

the second coupling apparatus connects the second tab region of the first leaflet layer and the first tab region of the third leaflet layer to the stent, including a flap of the backing layer of the second coupling apparatus wrapped about a second strut segment; and

the third coupling apparatus connects the second tab region of the second leaflet layer and the second tab region of the third leaflet layer to the stent, including a flap of the backing layer of the third coupling apparatus wrapped about a third strut segment.

14. The prosthetic valve of claim 1, wherein the backing layer is a polyester material.

15. The stented prosthetic heart valve of claim 7, wherein the plurality of leaflets further includes a second leaflet layer having a first tab region;

wherein the respective tab regions of the first and second leaflet layers are affixed between the bases of the first and second backing layers;

and further wherein the flaps of the first backing layer and the flap of the second backing layer do not overlap, the first and second strut segments combining to form a portion of a cell of the stent.

16. The prosthetic valve of claim 1, wherein the backing layer is wrapped about one of the first and second strut segments at least two full turns.

17. The prosthetic valve of claim 1, wherein the backing layer defines a receiving slot, and further wherein the first flap is wrapped about the first strut segment and passes through the receiving slot.

18. The prosthetic valve of claim 1, wherein relative to a central axis defined by the stent the pin is radially outward of the guide plate, and the first strut segment is radially outward of the pin.