Quick-Release Annuloplasty Ring Holder

• US 20090299470A1
• Filed: 05/07/2009
• Published: 12/03/2009
• Est. Priority Date: 05/09/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rao, Anand R., Fann, Hilda Z.
• Granted Patent: US 8,152,844 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• 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
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

A holder for an annuloplasty ring having a template defining a proximal face opposite the distal face, and a peripheral edge about which the annuloplasty ring conforms. The annuloplasty ring anchors to the template using one or more flexible filaments. The template includes a single cutting well on its proximal face over which the flexible filament is suspended. Desirably, the single cutting well is located adjacent the peripheral edge so as to be away from any handle connections for ease of access. The flexible filament emerges above the proximal face of the template at only one location at the cutting well, thus presenting a one cut quick-release structure that is highly visible to the surgeon. The annuloplasty ring may have a relatively rigid inner core surrounded by a suture-permeable cover, and the peripheral edge may be formed by a lower axial wall and an upper radial ledge that projects outward from the rigid inner core but not quite as far as a sewing margin of the ring. The ring and holder may be for mitral annuloplasty rings and generally have a D shape in plan view, and may be three-dimensional with upward anterior and posterior bows.

Claims

1. An annuloplasty ring and holder assembly, comprising:

an annuloplasty ring including a suture-permeable outer cover;

a template having an upper, proximal face and a lower, distal face and a peripheral edge sized and adapted to receive the annuloplasty ring in conformal contact therewith, the template further including a single cutting well adjacent the peripheral edge defined by a pair of spaced apart walls extending upward from the proximal face, and two spaced cleats adjacent the template peripheral edge each positioned at least 90°

circumferentially around the peripheral edge from the cutting well; and

a flexible connecting filament having its free ends anchored to the two spaced cleats and a mid-portion passing through at least two points on the annuloplasty ring outer cover and emerging above the proximal face of the template at only one location where it is suspended across the cutting well.

2. The assembly of claim 1, wherein the two spaced cleats are equidistantly positioned circumferentially around the peripheral edge from the cutting well.

3. The assembly of claim 1, wherein the template peripheral edge defines a substantially angled channel for receiving the annuloplasty ring formed by a generally axially-extending distal wall and an outwardly extending proximal ledge defining an outer extent of the template.

4. The assembly of claim 3, wherein the included angle of the angled channel between the distal wall and the proximal ledge varies around the peripheral edge.

5. The assembly of claim 1, wherein the template peripheral edge includes an outwardly extending proximal ledge, and wherein the two spaced cleats are each formed by a first pair of holes through the proximal ledge recessed below the proximal face.

6. The assembly of claim 5, further including a second pair of holes through the proximal ledge located between each of the first pairs of holes and the cutting well, wherein the filament ties to each first pair of holes, passes through the annuloplasty ring outer cover, loops up and down through the second pair of holes, and continues under the proximal ledge until emerging above the proximal face of the template to be suspended across the cutting well.

7. The assembly of claim 1, wherein the template further includes a coupler to which a handle member connects, the coupler being located adjacent the peripheral edge diametrically opposite the cutting well.

8. The assembly of claim 1, wherein the annuloplasty ring includes a generally rigid inner core surrounded by the suture-permeable outer cover, the template peripheral edge is partly formed by an outwardly extending proximal ledge defining an outer extent of the template, and wherein the proximal ledge extends radially outward from the rigid inner core when the annuloplasty ring is received in conformal contact with the peripheral edge and the suture-permeable outer cover extends outward from the proximal ledge.

9. The assembly of claim 1, further including a second flexible connecting filament anchored to the template at two free ends near to and on opposite sides of the cutting well, wherein a portion of the second flexible connecting filament extends between the two free ends above the proximal face of the template where it is suspended across the cutting well.

11. The holder of claim 9, wherein the template peripheral edge has a major axis and major dimension and a minor axis and minor dimension smaller than the major dimension, and the single cutting well is located along the minor axis.

12. The holder of claim 9, wherein the template peripheral edge circumscribes at least one visibility window that occupies a majority of the cross-sectional area within the peripheral edge.

13. The holder of claim 9, wherein the template peripheral edge defines a substantially angled channel for receiving the annuloplasty ring formed by a generally axially-extending distal wall and an outwardly extending proximal ledge defining an outer extent of the template.

14. The holder of claim 13, wherein the included angle of the angled channel between the distal wall and the proximal ledge varies around the peripheral edge.

15. The holder of claim 9, wherein the template includes two spaced cleats adjacent the template peripheral edge each positioned at least 90°

circumferentially around the peripheral edge from the cutting well and to which a flexible connecting filament may be anchored.

17. The method of claim 13, wherein the template peripheral edge has a major axis and major dimension and a minor axis and minor dimension smaller than the major dimension, and the single cutting well is located along the minor axis.

18. The method of claim 14, wherein the annuloplasty ring is for the mitral annulus, and the template peripheral edge has a posterior segment opposite an anterior segment across the minor axis, and the single cutting well is located on the posterior segment.

19. The method of claim 13, wherein the template peripheral edge circumscribes at least one visibility window that occupies a majority of the cross-sectional area within the peripheral edge, the method including viewing the target annulus through the visibility window.

20. The method of claim 13, wherein the template peripheral edge defines a substantially angled channel for receiving the annuloplasty ring formed by a generally axially-extending distal wall and an outwardly extending proximal ledge defining an outer extent of the template.

10. An annuloplasty ring holder, comprising:

a template having an upper, proximal face and a lower, distal face and a peripheral edge sized and adapted to receive an annuloplasty ring in conformal contact therewith, the template including a single flexible connecting filament cutting well adjacent the peripheral edge defined by a pair of spaced apart walls extending upward from the proximal face, wherein the template further includes a coupler to which a handle member connects, the coupler being located adjacent the peripheral edge diametrically opposite the cutting well.

16. A method of delivering an annuloplasty ring to a target annulus, comprising:

preparing an annuloplasty ring and template assembly for delivery, the template having an upper, proximal face and a lower, distal face and a peripheral edge sized and adapted to receive the annuloplasty ring in conformal contact therewith, the template further including a single cutting well adjacent the peripheral edge defined by a pair of spaced apart walls extending upward from the proximal face, wherein a flexible connecting filament anchored to the template holds the annuloplasty ring against the peripheral edge and bridges the cutting well, the template further including a coupler on the peripheral face to which a handle member connects, the coupler being located adjacent the peripheral edge diametrically opposite the cutting well;

connecting a handle member to the coupler;

distally advancing the annuloplasty ring and template assembly into proximity with the target annulus; and

severing the flexible connecting filament at the cutting well thus releasing the annuloplasty ring from the template with a single severing step.

21. A set of annuloplasty ring holders, each comprising:

a template having an upper, proximal face and a lower, distal face and a peripheral edge sized and adapted to receive the annuloplasty ring in conformal contact therewith, the peripheral edge defining a 3-dimensional contour, and wherein templates for different sized rings have different contours proportionally.