Holders for prosthetic aortic heart valves

• US 20070244551A1
• Filed: 04/14/2006
• Published: 10/18/2007
• Est. Priority Date: 04/14/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Stobie, Robert
• Granted Patent: US 7,806,926 B2
• Time in Patent Office: Days
• US Class Current: 623/2.100
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

A holder for a flexible leaflet prosthetic aortic heart valve that is less bulky than earlier holders and minimizes obstructions to vision and working space around the valve to facilitate implantation thereof. The holder may have a central hub and three outwardly extending legs that connect directly and exclusively to tips of the commissures of the aortic heart valve for better tactile feedback when parachuting and seating the valve in the annulus. The legs are sized so that they do not overlap the commissure tips and therefore afford a better view of the sewing ring adjacent the commissures. The legs may be narrow in the midsection or split into two rails to increase visibility of the valve leaflets. The hub may be vaulted axially upward relative to the outer ends of the legs to further increase visibility of the valve. A more secure engagement between the central hub and a delivery handle is also provided to ensure the holder/handle connection does not become loose during suture placement through the sewing ring and fewer handle revolutions are required to screw in and unscrew the handle from the holder.

Claims

1. A prosthetic aortic heart valve and holder combination, comprising:

a prosthetic aortic heart valve having an inflow end and an outflow end, the outflow end being defined by a plurality of generally axially extending commissure posts terminating in commissure tips;

a holder for the prosthetic aortic heart valves having a central hub and a plurality of legs radially outwardly projected from the hub such that an outer end of each of the legs is located in proximity with one of the commissure tips; and

at least one attachment member connecting each of the legs exclusively and directly to a corresponding tip of one of the commissure posts, the attachment member extending from the holder just to the commissure tip.

2. The combination of claim 1, wherein the prosthetic aortic heart valve has flexible leaflets.

3. The combination of claim 2, wherein the prosthetic aortic heart valve is constructed with a fabric-covered inner stent member that extends up the commissure posts to the commissure tips, and wherein the holder legs project radially outward to contact the commissure tips at the radial location of the inner stent member but not as far as an outer radial extent of the commissure posts.

4. The combination of claim 1, wherein the commissure tips are fabric-covered and have a rounded configuration, and wherein an inflow side of the outer ends of each of the holder legs has a concave configuration to match the rounded commissure tips.

5. The combination of claim 1, wherein the outer end of each of the legs has valve attachment structure and a first width as seen in axial plan view, each of the legs further including a mid-section extending between the central hub and the outer end that has a total material width as seen in axial plan view that is less than 50% of the first width for enhanced visibility of the valve.

6. The combination of claim 5, wherein the total material width as seen in axial plan view of each mid-section is less than 33% of the outer end width.

7. The combination of claim 5, wherein each of the legs has a single member mid-section narrower than the outer ends.

8. The combination of claim 1, wherein each of the legs has a mid-section that is split into two slim rails that are joined together at the outer end, and wherein a radial gap is formed between the rails enabling direct axial viewing of the heart valve therethrough.

9. The combination of claim 1, wherein each of the legs has an axial component so as to vault the central hub away from the heart valve.

10. The combination of claim 1, wherein the attachment members are sutures and each holder leg includes a cavity over which the corresponding attachment suture passes to enable the suture to be easily severed using a sharp.

11. A prosthetic heart valve holder comprising a central hub defining a central axis and a plurality of elongated legs projecting outwardly from an inflow end of the hub, each of the legs terminating at an outer end having valve attachment structure and a first width as seen in axial plan view, each of the legs further including an elongated mid-section extending between the central hub and the outer end that has a total material width as seen in axial plan view that is less than 50% of the first width for enhanced visibility of a valve secured to the holder.

12. The holder of claim 11, wherein the mid-section of each of the legs is split into two slim rails that are joined together at the outer end, and wherein a radial gap is formed between the rails enabling direct axial viewing of a heart valve attached to the holder.

13. The holder of claim 12, wherein the two slim rails have a total material width as seen in axial plan view that is less than 50% of the first width.

14. The holder of claim 12, wherein each of the two slim rails has an axial component so as to vault the central hub axially from the outer ends of the legs.

15. The holder of claim 11, wherein each of the legs has an axial component so as to vault the central hub axially from the outer ends of the legs.

16. The holder of claim 15, wherein each of the legs has an axially and radially angled segment and a purely radial segment.

17. The holder of claim 11, wherein each of the legs has a single member mid-section narrower than the outer ends.

18. The holder of claim 17, wherein each of the legs has an axial component so as to vault the central hub axially from the outer ends of the legs.

19. The holder of claim 11, wherein the elongated mid-section has a total material width as seen in axial plan view that is less than 33% of the first width.

20. The holder of claim 11, wherein an inflow side of the outer ends of each of the holder legs has a concave configuration.