Actively-engageable movement-restriction mechanism for use with an annuloplasty structure

• US 8,353,956 B2
• Filed: 02/17/2010
• Issued: 01/15/2013
• Est. Priority Date: 02/17/2009
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Miller, Eran, Gross, Amir, Cabiri, Oz, Beinart, Iftah, Baum, Aviram
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US12/706,868
• Publication Number:
  US 20100211166A1
• Time in Patent Office: 1,063 Days
• Field of Search: 623/2.36, 623/2.37
• US Class Current: 623/2.37
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

Apparatus is provided, including a locking mechanism, an implant, and a flexible strip within the implant having a plurality of recesses. A perimeter of the strip shortens and expands when the first end of the strip is advanced bidirectionally with respect to a second end of the strip. The locking mechanism includes a moveable recess-engaging portion, a mechanical support removably coupled to the recess-engaging portion, and a force applicator which maintains the recess-engaging portion in a position in which the recess-engaging portion is not disposed in any of the recesses. Upon decoupling of the mechanical support from the recess-engaging portion, the force applicator restricts motion of the plurality of recesses of the strip with respect to the second end of the strip, by facilitating positioning of the recess-engaging portion in one of the plurality of recesses. Other embodiments are also described.

Claims

1. Apparatus, comprising:

a locking mechanism;

a housing surrounding the locking mechanism;

an implant shaped so as to define an implant lumen therethrough; and

a flexible strip disposed at least in part within the implant lumen, the strip shaped so as to define;

a first end,

a second end, and

a plurality of recesses,

wherein the first and second ends are coupled to the locking mechanism such that the strip defines a closed loop and a perimeter thereof which (a) shortens when the first end is advanced through the locking mechanism in a first direction and (b) expands when the first end is advanced in a second direction opposite the first direction,

wherein the locking mechanism comprises;

a moveable recess-engaging portion;

a lever arm coupled to the recess-engaging portion;

a mechanical support, removably coupled to the recess-engaging portion by being removably positioned between the recess-engaging portion and the

plurality of recesses so as to prevent the recess-engaging portion from engaging

any one of the plurality of recesses; and

a force applicator which maintains the recess-engaging portion in a position in which the recess-engaging portion is not disposed in any of the recesses during the advancing of the first end, and which, upon decoupling of the mechanical support from the recess-engaging portion, restricts motion of the plurality of recesses of the strip with respect to the second end of the strip, by facilitating positioning of the recess-engaging portion in one of the plurality of recesses,

wherein during the decoupling of the mechanical support, the mechanical support is pulled away from the lever arm, which allows the lever arm to pivot along the force applicator such that (1) the lever arm lies in parallel with a longitudinal axis of the housing, and (2) the recess-engaging portion is disposed within one of the plurality of recesses.

2. The apparatus according to claim 1, wherein the force applicator comprises a spring.

3. The apparatus according to claim 1, wherein, for each one of the recesses, the strip is shaped to provide first and second opposing walls which define the recess, the first wall having a dimension that is substantially the same as a dimension of the second wall.

4. The apparatus according to claim 1, wherein the implant comprises expanded polytetrafluoroethylene (ePTFE).

5. The apparatus according to claim 1, wherein the implant is coated with polytetrafluoroethylene.

6. The apparatus according to claim 1, wherein the apparatus is configured to be implanted along an annulus of a mitral valve of a patient, and wherein the apparatus is configured to be transcatheterally advanced toward the annulus.

7. The apparatus according to claim 1, further comprising a flexible member disposed within the lumen of the implant and alongside the strip, the flexible member being configured push against the strip to contract the strip and facilitate passive advancement of the first end of the strip through the locking mechanism.

8. The apparatus according to claim 7, wherein:

the implant is configured to be implanted along an annulus of a mitral valve of a patient,

the flexible member is configured to contract the implant when the flexible member is pulled, and

the implant is configured to contract the annulus in response to the contraction thereof.

9. The apparatus according to claim 1, wherein:

the implant comprises an outer body portion shaped to define the lumen,

when formed into the closed loop, the flexible strip is shaped to provide an inner surface and an outer surface, and

the apparatus further comprises an inner body portion coupled at at least a portion thereof to the outer surface of the strip, the inner body portion being shaped so as to define an inner body lumen therethrough.

10. The apparatus according to claim 9, wherein the apparatus further comprises a flexible member configured for slidable advancement through the inner body lumen, the flexible member being configured to push against the strip to contract the strip and to facilitate passive advancement of the first end of the strip with respect to the second end of the strip.

11. The apparatus according to claim 9, wherein the inner body portion is compressible.

12. The apparatus according to claim 9, wherein the inner body portion comprises expanded polytetrafluoroethylene (ePTFE).

13. The apparatus according to claim 1, wherein:

the apparatus is configured to be implanted along an annulus of a mitral valve of a heart of a patient,

a first section of the implant is flexible and longitudinally-compressible, and

a second section, in series with the first section of the implant, is flexible and less longitudinally-compressible than the first section.

14. The apparatus according to claim 13, wherein the second section is not longitudinally-compressible.

15. The apparatus according to claim 13, wherein a radius of curvature at a center of the first section is smaller than a radius of curvature at a center of the second section, when no external force is applied to the implant.

16. The apparatus according to claim 13, wherein the second section of the implant has first and second ends thereof and a body portion disposed between the first and second ends of the second section, the second section of the implant being configured to be disposed along a portion of the annulus in a manner in which:

the first end of the second section is configured to be coupled to the annulus in a vicinity of a left trigone of the heart that is adjacent to the mitral valve of the patient,

the second end of the second section is configured to be coupled to the annulus in a vicinity of a right trigone of the heart that is adjacent to the mitral valve, and

the body portion is configured to be disposed along the annulus in a vicinity of the annulus that is between the left and right trigones.

17. The apparatus according to claim 16, wherein the body portion disposed between the first and second ends of the second section of the implant has a length of 10-50 mm.

18. Apparatus, comprising:

an implant comprising a flexible longitudinal member having first and second ends that are opposable to form the longitudinal member into a closed loop having a perimeter thereof which (a) shortens when the first end is advanced in a first direction with respect to the second end in a first direction and (b) expands when the first end is advanced with respect to the second end in a second direction opposite to the first direction, and

when formed into the closed loop, the longitudinal member is shaped to provide an inner surface and an outer surface with respect to a center of the closed loop;

a body portion coupled at at least a portion thereof to the outer surface of the longitudinal member, the body portion being shaped so as to define a body portion lumen therethrough;

a flexible contracting member being disposed within and slidably advanceable through the body portion lumen to facilitate a modulation of a perimeter of the body portion, which, in turn facilitates a modulation of a perimeter of the longitudinal member; and

a tubular structure shaped so as to define a tubular structure lumen therethrough, wherein;

the flexible longitudinal member is disposed at least in part within the tubular structure lumen, and

the longitudinal member is configured to facilitate a modulation of a perimeter of the tubular structure in response to the modulation of the perimeter of the longitudinal member.

19. The apparatus according to claim 18, wherein the implant comprises an annuloplasty ring.