Partially-adjustable annuloplasty structure

• US 9,011,530 B2
• Filed: 06/23/2011
• Issued: 04/21/2015
• Est. Priority Date: 12/22/2008
• Status: Expired due to Fees

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Reich, Tal, Hammer, Tal, Pomerantz, Uriel Aba, Cabiri, Oz
• Primary Examiner(s): Woznicki, Jacqueline
• Application Number:
  US13/167,444
• Publication Number:
  US 20120022644A1
• Time in Patent Office: 1,398 Days
• Field of Search: 623/2.37
• US Class Current: 623/2.37
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• 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
• CPC Class Codes: A61F 2250/0004 adjustable

Abstract

Apparatus and methods are described including an annuloplasty structure configured for implantation along an annulus of an atrioventricular valve of a heart of a subject. The structure includes a coiled element comprising at least one first portion thereof which is flexible and longitudinally compressible, and at least one second portion thereof in series with the first portion, the second portion being flexible and less longitudinally compressible than the first portion. Other applications are also described.

Claims

1. Apparatus, comprising:

an annuloplasty structure configured for implantation along an annulus of an atrioventricular valve of a heart of a subject, the structure comprising;

a sleeve defining a lumen therethrough;

an elongate coiled element disposed entirely within the lumen of the sleeve, the coiled element comprising;

at least one first coiled portion having coils that are flexible and longitudinally compressible; and

at least one second coiled portion in series with the first coiled portion, the second coiled portion having coils that are flexible and less longitudinally compressible than the coils of the first coiled portion;

a contracting member disposed within a lumen of the coiled element, the contracting member being slidable through the first and second coiled portions of the coiled element in order to adjust a perimeter of the annuloplasty structure; and

a contracting mechanism coupled to a portion of the contracting member, the contracting mechanism being;

attached to the coiled element at the second coiled portion, and

configured to adjust the perimeter of the annuloplasty structure by applying a force to the contracting member,

wherein a length of the second coiled portion is 10-50 mm.

2. The apparatus according to claim 1, wherein the second coiled portion comprises first and second second-coiled-portion-elements, wherein the contracting mechanism is attached to the coiled element at the second coiled portion between the first and second second-coiled-portion-elements, and wherein the length of the second coiled portion comprises a combined length of the first and second second-coiled-portion-elements.

3. The apparatus according to claim 1, wherein a radius of curvature at a center of the first coiled portion is smaller than a radius of curvature at a center of the second coiled portion, when no external force is applied to the annuloplasty structure.

4. A method, comprising:

positioning an annuloplasty structure along an annulus of an atrioventricular valve of a subject, the annuloplasty structure including;

a sleeve defining a lumen therethrough, and

an elongate coiled element disposed entirely within the lumen of the sleeve, the coiled element including;

at least one first coiled portion having coils that are flexible and longitudinally compressible; and

at least one second coiled portion in series with the first coiled portion, the second coiled portion having coils that are flexible and less longitudinally compressible than the coils of the first coiled portion and having a length of 10-50 mm;

a contracting member disposed within a lumen of the coiled element, the contracting member being slidable through the first and second coiled portions of the coiled element in order to adjust a perimeter of the annuloplasty structure; and

a contracting mechanism coupled to a portion of the contracting member, the contracting mechanism being;

attached to the coiled element at the second coiled portion, and

configured to adjust the perimeter of the annuloplasty structure by applying a force to the contracting member;

fastening the annuloplasty structure to the annulus; and

adjusting the perimeter of the annuloplasty structure by applying the force to the contracting member and compressing the first coiled portion of the coiled element.

5. Apparatus, comprising:

an annuloplasty structure configured for implantation along an annulus of an atrioventricular valve of a heart of a subject and shaped so as to define a substantially “

D”

-shaped configuration having a straight portion and a curved portion, the structure comprising;

a sleeve defining a lumen therethrough;

an elongate coiled element disposed entirely within the lumen of the sleeve, the coiled element comprising;

at least one first coiled portion having coils that are flexible and longitudinally compressible, the curved portion of the annuloplasty structure comprising the first coiled portion; and

at least one second coiled portion in series with the first coiled portion, the second coiled portion having coils that are flexible and less longitudinally compressible than the coils of the first coiled portion, the straight portion of the annuloplasty structure comprising the second coiled portion;

a contracting member disposed within a lumen of the coiled element, the contracting member being slidable through the first and second coiled portions of the coiled element in order to adjust a perimeter of the annuloplasty structure; and

a contracting mechanism coupled to a portion of the contracting member, the contracting mechanism being;

attached to the coiled element at the straight portion of the annuloplasty structure, and

configured to adjust the perimeter of the annuloplasty structure by applying a force to the contracting member.

6. The apparatus according to claim 5, wherein the annuloplasty structure comprises an annuloplasty ring.

7. The apparatus according to claim 5, further comprising a contraction-restricting element configured to be coupled to the second coiled portion of the coiled element, wherein the second coiled portion is configured to be flexible and less longitudinally compressible than the first coiled portion at least in part by virtue of the contraction-restricting element being coupled thereto.

8. The apparatus according to claim 7, wherein the contraction-restricting element comprises an element selected from the group consisting of:

a suture, a staple, a ratchet mechanism, and a bracket.

9. The apparatus according to claim 5, wherein the valve includes a native mitral valve of the subject, and wherein the structure is configured for implantation along a native annulus of the native mitral valve in a manner in which at least the first coiled portion of the annuloplasty structure is disposed along a portion of the annulus at a posterior leaflet of the valve.

10. The apparatus according to claim 9, wherein the second coiled portion is configured to restrict contraction of the second coiled portion while facilitating radial movement of the second coiled portion of the annuloplasty structure.

11. The apparatus according to claim 5,

wherein the atrioventricular valve includes a mitral valve,

wherein the coiled element comprises a plurality of second-coiled-portion-elements, and

wherein the annuloplasty structure is configured for implantation along the annulus in a manner in which:

a first second-coiled-portion-element of the second-coiled-portion-elements is configured to be coupled to the annulus in a vicinity of a left trigone adjacent to the mitral valve, and

a second second-coiled-portion-element of the second-coiled-portion-elements is configured to be coupled to the annulus in a vicinity of a right trigone adjacent to the mitral valve.

12. The apparatus according to claim 11, wherein a combined length of the first and second second-coiled-portion-elements is 10-50 mm.

13. The apparatus according to claim 5, wherein:

the sleeve has first and second end portions and a body portion that is between the first and second end portions; and

the contracting member extends along the body portion between the first and second end portions of the sleeve, the contracting member having first and second end portions, the first end portion of the contracting member being coupled to the sleeve in a vicinity of the first end portion thereof, and the second end portion of the contracting member being coupled to the sleeve in a vicinity of the second end portion thereof.

14. The apparatus according to claim 13, wherein the annuloplasty structure is configured to be implanted along an annulus of a mitral valve of the subject in a manner in which the annuloplasty structure is formed into at least a portion of an annuloplasty ring.

15. The apparatus according to claim 5, wherein the coiled element is longitudinally slidable within the lumen of the sleeve.

16. The apparatus according to claim 5, wherein the contracting member is threaded one or more times through the sleeve.

17. The apparatus according to claim 5, wherein a radius of curvature at a center of the first coiled portion is smaller than a radius of curvature at a center of the second coiled portion, when no external force is applied to the annuloplasty structure.

18. A method, comprising:

positioning along an annulus of an atrioventricular valve of a subject an annuloplasty structure shaped so as to define a substantially “

D”

-shaped configuration having a straight portion and a curved portion, the annuloplasty structure including;

a sleeve defining a lumen therethrough, and

an elongate coiled element disposed entirely within the lumen of the sleeve, the coiled element including;

at least one first coiled portion having coils that are flexible and longitudinally compressible, the curved portion of the annuloplasty structure comprising the first coiled portion; and

at least one second coiled portion in series with the first coiled portion, the second coiled portion having coils that are flexible and less longitudinally compressible than the coils of the first coiled portion, the straight portion of the annuloplasty structure comprising the second coiled portion;

a contracting member disposed within a lumen of the coiled element, the contracting member being slidable through the first and second coiled portions of the coiled element in order to adjust a perimeter of the annuloplasty structure; and

a contracting mechanism coupled to a portion of the contracting member, the contracting mechanism being;

attached to the coiled element at the straight portion of the annuloplasty structure, and

configured to adjust the perimeter of the annuloplasty structure by applying a force to the contracting member;

fastening the annuloplasty structure to the annulus; and

adjusting the perimeter of the annuloplasty structure by applying the force to the contracting member and compressing the first coiled portion of the coiled element.

19. The method according to claim 18, further comprising coupling a contraction-restricting element to an outer surface of the annuloplasty structure.

20. The method according to claim 18, wherein adjusting comprises restricting contraction of the second coiled portion of the annuloplasty structure while facilitating radial movement of the second coiled portion of the annuloplasty structure.

21. The method according to claim 18, wherein positioning the annuloplasty structure along the annulus of the atrioventricular valve comprises positioning the annuloplasty structure in a manner in which the curved portion of the annuloplasty structure is disposed along a portion of the annulus at a posterior leaflet of the valve, and the straight portion is disposed along a portion of the annulus at an anterior leaflet of the valve.