Annuloplasty Ring and Holder Combination

• US 20110015727A1
• Filed: 05/24/2010
• Published: 01/20/2011
• Est. Priority Date: 03/23/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Ingle, Aaron S., Adzich, W. Vaso, Fann, Hilda Zhang
• Granted Patent: US 8,216,304 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

An annuloplasty ring holder includes an angled post for improved visibility and access by the surgeon. The post may be configured to be adjusted in angle and rotation. The ring holder can include a relatively open lower template, including relatively narrow extending radial arms with short, generally arcuate ring-retaining distal portions. The invention includes placements of suture holes and cutting wells which, in combination with improved suture routing, afford the user improved access to cutting the suture that is used to retain the annuloplasty ring to the holder. Another annuloplasty ring and ring holder combination disclosed includes a generally triangular-shaped ring and a generally T-shaped holder. The ring holder has a base portion forming the top of the T shape and engaging against a first segment of the ring, with a radial arm extending from the base portion and forming the post of the T. The radial arm engages against a junction between two segments of the ring.

Claims

1. An annuloplasty ring and holder assembly combination, comprising:

an annuloplasty ring having a continuous periphery with an elongated generally oval-shape in plan view defining a major axis and a corresponding major axis dimension across a widest span, and a minor axis perpendicular to the major axis and across the middle of the annuloplasty ring, and a corresponding minor axis dimension, the major axis dimension being substantially longer than the minor axis dimension; and

a ring holder, comprising;

an upstanding post having an attachment assembly to which a handle can be removably secured;

a lower template portion secured to the post and including first and second narrow arms extending outward in generally opposite directions from the post and terminating in first and second ring securing segments having suture holes, each of the ring securing segments having an arcuate shape oriented to be convex outward and being narrow in a radial direction so as to form a T-shape with the associated narrow arm, and wherein the ring securing segments are spaced apart a distance approximately equal to the major axis dimension so that the ring securing segments each engage and conform to an inner edge of the annuloplasty ring, wherein the narrow arms and narrow arcuate ring securing segments leave open a large portion of the area enclosed by the annuloplasty ring thus enhancing visibility therethrough; and

restraining sutures between the ring securing segments and the arcuate sides of the annuloplasty ring releasably securing the ring holder to the annuloplasty ring.

2. The combination of claim 1, wherein in plan view the annuloplasty ring has a posterior portion opposite an anterior portion both generally aligned with the major axis, and arcuate sides generally aligned with the minor axis, and wherein a mid-section of the posterior portion bows inward toward the anterior portion.

3. The combination of claim 1, wherein in plan view the annuloplasty ring has a posterior portion opposite an anterior portion both generally aligned with the major axis, and arcuate sides generally aligned with the minor axis, and wherein a mid-section of the posterior portion bows inward toward the anterior portion and upward in a Z-direction perpendicular to both the major and minor axes.

4. The combination of claim 3, wherein the lower template portion further includes a pair of knobs extending outward in generally opposite directions from the post and generally perpendicular to the first and second narrow arms, each knob extending a distance so as to engage an inner edge of the anterior and posterior portions of the annuloplasty ring, respectively.

5. The combination of claim 4, further including restraining sutures between the each knob and the anterior and posterior portions of the annuloplasty ring, respectively.

6. The combination of claim 1, wherein the major axis dimension is more than twice as long as the minor axis dimension.

7. The combination of claim 1, wherein the annuloplasty ring comprises an inner titanium substrate and an outer biocompatible fabric cover.

8. The combination of claim 1, further comprising a handle releasably secured to the upstanding post, wherein the post includes structure to adjust and fix the angle of attachment of the handle relative to the lower template.

9. An annuloplasty ring and holder assembly combination, comprising:

an annuloplasty ring having a continuous periphery with an elongated generally oval-shape in plan view defining a posterior portion opposite an anterior portion both generally aligned with a major axis, the continuous periphery having a corresponding major axis dimension across a widest span, the continuous periphery further defining arcuate sides generally aligned with a minor axis perpendicular to the major axis and across the middle of the annuloplasty ring, and a corresponding minor axis dimension, the major axis dimension being longer than the minor axis dimension, and wherein a mid-section of the posterior portion bows inward toward the anterior portion and upward in a Z-direction perpendicular to both the major and minor axes.

a ring holder, comprising;

an upstanding post having an attachment assembly to which a handle can be removably secured;

a lower template portion secured to the post and including first and second narrow arms extending outward in generally opposite directions from the post and terminating in first and second arcuate segments oriented to be convex outward and being spaced apart a distance approximately equal to the major axis dimension so that the arcuate segments each engage and conform to an inner edge of the arcuate sides of the annuloplasty ring;

a pair of knobs extending outward in generally opposite directions from the post and generally perpendicular to the first and second narrow arms, each knob extending a distance so as to engage a portion of the inner edge of the anterior and posterior portions of the annuloplasty ring, respectively, the knobs being offset from each other in the Z-direction; and

restraining sutures between the ring holder and the annuloplasty ring releasably securing the ring holder to the annuloplasty ring.

10. The combination of claim 9, wherein restraining sutures secure the arcuate segments to the arcuate sides of the annuloplasty ring.

11. The combination of claim 9, wherein restraining sutures secure each knob to the anterior and posterior portions of the annuloplasty ring, respectively.

12. The combination of claim 9, wherein the major axis dimension is more than twice as long as the minor axis dimension.

13. The combination of claim 9, wherein the annuloplasty ring comprises an inner titanium substrate and an outer biocompatible fabric cover.

14. The combination of claim 9, further comprising a handle releasably secured to the upstanding post, wherein the post includes structure to adjust and fix the angle of attachment of the handle relative to the lower template.

15. An annuloplasty ring and holder assembly combination, comprising:

an annuloplasty ring having a continuous periphery with an elongated generally oval-shape in plan view defining a major axis and a corresponding major axis dimension across a widest span, and a minor axis perpendicular to the major axis and across the middle of the annuloplasty ring, and a corresponding minor axis dimension, the major axis dimension being at least twice as long as the minor axis dimension; and

a ring holder, comprising;

an upstanding post having an attachment assembly to which a handle can be removably secured;

a lower template portion secured to the post and including first and second arms extending outward in generally opposite directions from the post and terminating in first and second securing segments spaced apart a distance approximately equal to the major axis dimension so that the securing segments each engage an inner edge of the annuloplasty ring, each securing segment defining at least one suture cutting well therein;

at least one restraining suture between each securing segment and the engaged portion of the annuloplasty ring that extends over the cutting well in the corresponding securing segment to releasably secure the ring holder to the annuloplasty ring, wherein there are no other restraining sutures than those that secure the securing segments to the annuloplasty ring.

16. The combination of claim 15, wherein a mid-section of the posterior portion bows inward toward the anterior portion.

17. The combination of claim 15, wherein a mid-section of the posterior portion bows inward toward the anterior portion and upward in a Z-direction perpendicular to both the major and minor axes.

18. The combination of claim 17, wherein the lower template portion further includes a pair of knobs extending outward in generally opposite directions from the post and generally perpendicular to the first and second narrow arms, each knob extending a distance so as to engage an inner edge of the anterior and posterior portions of the annuloplasty ring, respectively, the knobs being offset from each other in the Z-direction.

19. The combination of claim 15, wherein the annuloplasty ring comprises an inner titanium substrate and an outer biocompatible fabric cover.

20. The combination of claim 15, further comprising a handle releasably secured to the upstanding post, wherein the post includes structure to adjust and fix the angle of attachment of the handle relative to the lower template.