Stented Prosthetic Heart Valve and Methods for Making

• US 20140277418A1
• Filed: 03/15/2013
• Published: 09/18/2014
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Original Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Inventors: Miller, Noam
• Granted Patent: US 9,232,994 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• 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 generally tubular body, the struts forming 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 frame,

a pin apart from the stent frame,

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 strut segments to mount the first leaflet to the stent.

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 slot.

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 support 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.

6. The prosthetic valve of claim 1, wherein the backing layer is wrapped about a plurality of the strut segments of the stent.

7. The prosthetic valve of claim 1, wherein the backing layer includes a base and a first flap, 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 a first one of the strut segments.

8. The prosthetic valve of claim 7, wherein the backing layer further includes a second flap projecting from the base, and further wherein the second flap is wrapped about a second one of the strut segments.

9. 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.

10. The prosthetic valve of claim 9, wherein the first and second backing layers each include a base and a first flap, and further wherein:

the first tab region is disposed between the bases;

the first flap of the first backing layer is wrapped about a first strut segment; and

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

11. The prosthetic valve of claim 10, 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 first backing layer is wrapped about a third strut segment; and

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

12. 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.

13. The prosthetic valve of claim 12, 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.

14. The prosthetic valve of claim 13, wherein the pin is disposed between the first and second leaflet layers adjacent the guide plate.

15. The prosthetic valve of claim 14, 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.

16. The prosthetic valve of claim 12, 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-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.

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

18. A stented prosthetic heart valve comprising:

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

a plurality of leaflet assemblies mounted to the stent, wherein at least one of the leaflet assemblies includes;

first and second backing layers each including a base and a flap,

first and second leaflet layers each including a leaflet and a tab region,

wherein the tab regions of the leaflet layers are affixed between the bases;

wherein the flap of the first backing layer is attached to a first strut segment and the flap of the second backing layer is attached to a second strut segment, the first and second strut segments combining to form a portion of a cell of the stent.

19. A method of manufacturing a stented prosthetic valve, the method comprising:

securing a leaflet layer to a backing layer at an interface between a guide plate and a pin;

attaching the backing layer to a strut segment formed by a stent to provide a leaflet assembly affixed to the stent, the stent including a plurality of struts combining to define a tubular body;

wherein the guide plate and the pin are independent of the struts comprising the stent.

20. The method of claim 19, wherein the step of securing a leaflet layer to a backing layer includes:

inserting a tab region of the leaflet layer and a base of the backing layer through a passageway defined by the guide plate;

lodging the tab region and the base between the pin and the guide plate; and

connecting the pin and the guide plate to frictionally secure the tab region and the base to one another in an abutting relationship.

21. The method of claim 20, wherein the backing layer includes a flap projecting from the base, and further wherein the base abuts the tab region between the guide plate and the pin, and even further wherein the step of attaching the backing layer to a strut segment formed by the stent frame includes wrapping the flap about the strut segment.