Segmented ring placement

• US 8,926,695 B2
• Filed: 12/05/2007
• Issued: 01/06/2015
• Est. Priority Date: 12/05/2006
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Gross, Amir, Beinart, Iftah, Eliachar, Eliahu, Lilach, Nir, Grossfeld, Ram, Golom, Dmitry, Meyer-Brodnitz, Gideon, Mosaiuf, Arnon
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US11/950,930
• Publication Number:
  US 20080262609A1
• Time in Patent Office: 2,589 Days
• Field of Search: 623/2.36, 623/2.37
• US Class Current: 623/2.36
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• 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 2017/00783 Valvuloplasty
• 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 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2250/006 modular

Abstract

Apparatus is provided for repairing a valve of a patient, the valve including an annulus and at least first and second leaflets. The apparatus includes at least a first discrete segment and a second discrete segment of an annuloplasty structure, each segment being shaped to provide a respective lateral wall, each lateral wall being shaped to define at least one lumen of the respective segment. The apparatus further includes at least a first and a second control wire, each control wire configured for sliding advancement through both the first and second segments. The first control wire is configured to control a relative disposition of a first end of the first segment and a first end of the second segment. The second control wire is configured to control a relative disposition of a second end of the first segment and a second end of the second segment. Other embodiments are also described.

Claims

1. Apparatus for repairing a valve of a body of a patient, the valve including an annulus and at least first and second leaflets, comprising:

at least a first segment and a second segment of an annuloplasty structure, the first segment being shaped to define at least one first lumen, and the second segment being shaped to define at least one second lumen that is separate from the at least one first lumen of the first segment; and

at least a first and a second control wire, wherein;

a first slidable coupling arrangement, coupling the first control wire and the first segment via the at least one first lumen, and a second slidable coupling arrangement, coupling the second control wire and the second segment via the at least one second lumen, facilitate control by the control wires of relative dispositions of the first and second segments, at least in part in response to an application of pulling forces to the control wires.

2. The apparatus according to claim 1, wherein:

the first segment defines a first lateral wall that surrounds the first lumen,

the second segment defines a second lateral wall that surrounds the second lumen,

for each of the first and second lateral walls of each segment, the lateral wall has a first and a second portion, and the segment is shaped to provide a channel extending from the first portion to the second portion, and

the apparatus further comprises a bar configured to be disposed within the channel.

3. The apparatus according to claim 2, further comprising a flexible longitudinal guide member configured to be removably coupled to the bar.

4. The apparatus according to claim 3, further comprising an anchoring structure, wherein, while the guide member is disposed within the body of the patient, the anchoring structure is configured to be advanced via the guide member, through the channel, and subsequently anchored to the annulus of the patient.

5. The apparatus according to claim 4, wherein, while the guide member is disposed within the body of the patient, the anchoring structure is configured to be advanced along the guide member from a site outside the body of the patient.

6. The apparatus according to claim 5, wherein, while the guide member is disposed within the body of the patient, the guide member is configured to be decoupled from the bar subsequent to the anchoring of the anchoring structure to the annulus.

7. The apparatus according to claim 1, further comprising at least first and second flexible longitudinal guide members, the first and second guide members configured to be removably coupled to the first and second segments, respectively, each guide member being configured to facilitate anchoring of the respective segment to the annulus of the patient.

8. The apparatus according to claim 1, wherein the first and second control wires are configured to expand the first and second segments.

9. The apparatus according to claim 1, wherein the first and second control wires are configured to facilitate positioning of the first and second segments along the annulus.

10. The apparatus according to claim 1, wherein the first and second segments are configured to be advanced toward the valve of the patient in a generally straight configuration of the first and second segments, and wherein the first and second control wires are configured to pull the first and second segments into a curved configuration.

11. The apparatus according to claim 1, wherein the first control wire is configured to compress the first segment at least in part in response to an application of a pulling force to at least a portion of the first control wire, and wherein the second control wire is configured to compress the second segment at least in part in response to an application of a pulling force to at least a portion of the second control wire.

12. The apparatus according to claim 4, wherein:

the anchoring structure comprises a helical element, the helical element shaped to define at least two adjacent distal rotational subunits and at least two adjacent proximal rotational subunits, wherein a distance between the two adjacent distal rotational subunits is greater than a distance between the two adjacent proximal rotational subunits,

the distance between the distal rotational subunits enables the distal rotational subunits to be corkscrewed around the bar and subsequently into tissue of the patient, and

the distance between the proximal rotational subunits restricts the proximal rotational subunits from being corkscrewed into tissue of the patient.

13. The apparatus according to claim 1, further comprising a catheter, wherein the first and second segments are configured to be conveyed simultaneously through the catheter and toward the valve during a single transcatheter advancment.

14. The apparatus according to claim 13, wherein the catheter is shaped to provide a lumen along a longitudinal axis thereof, and wherein the catheter provides an arrangement for the placing of the first and second segments in the lumen of the catheter, linearly along the longitudinal axis in a manner in which one of the segments is disposed distally to the other segment.

15. The apparatus according to claim 1, wherein:

the first segment defines a first lateral wall that surrounds the first lumen,

the second segment defines a second lateral wall that surrounds the second lumen,

for each of the first and second lateral walls of each segment, the lateral wall has a first and a second portion, and the segment is shaped to provide a channel extending from the first portion to the second portion, and

the apparatus further comprises a flexible longitudinal guide member configured to be removably coupled to a portion of the wall of the segment in a vicinity of the channel.

16. The apparatus according to claim 15, further comprising an anchoring structure, wherein the anchoring structure is disposed at a distal end of the guide member, and wherein the distal end of the guide member is coupled to the portion of the wall of the segment.

17. The apparatus according to claim 12, wherein a diameter of the bar is greater than the distance between the proximal rotational subunits, and wherein during an attempt to corkscrew the proximal rotational subunits around the bar:

the bar restricts the proximal rotational subunits from being corkscrewed into tissue of the patient by applying a counterforce to a torque applied to the helical element in response to rotation thereof, and

the proximal rotational subunits are configured to expand radially in response to the counterforce applied by the bar.

18. The apparatus according to claim 17, further comprising a hollow tube configured to:

be reversibly coupled to the helical element,

push the anchoring structure toward the annuloplasty structure, and

provide torque to the helical element in response to rotation of the tube, and

wherein the helical element is configured to be detached from the hollow tube in response to the radial expansion of the proximal rotational subunits.

19. The apparatus according to claim 1, wherein the annuloplasty structure comprises an annuloplasty ring.

20. The apparatus according to claim 1, further comprising one or more flexible longitudinal guide members, each guide member configured to be removably coupled to respective portions of the annuloplasty structure, and wherein the annuloplasty structure and the one or more guide members are configured to be simultaneously advanced toward the valve of the patient.

21. The apparatus according to claim 1, wherein the annuloplasty structure comprises a partial annuloplasty ring.

22. The apparatus according to claim 1, wherein:

the annuloplasty structure has at least first and second free ends,

a first end of the first segment defines the first free end of the annuloplasty structure, and

a first end of the second segment defines the second free end of the annuloplasty structure.

23. The apparatus according to claim 10, wherein:

the straight configuration of the first and second segments defines a longitudinal axis of the annuloplasty structure,

at least a portion of the annuloplasty structure is shaped to define one or more compressible units, and

wherein the compressible units are compressible in parallel with the longitudinal axis.

24. The apparatus according to claim 23, wherein the compressible units are compressible in response to an application of a pulling force applied to one or more control wires selected from the group consisting of:

the first control wire and the second control wire.

25. The apparatus according to claim 1, wherein:

the first segment has a first lateral wall that defines the first lumen,

the second segment has a second lateral wall that defines the second lumen, and

the first and second lateral walls are discrete from each other.

26. The apparatus according to claim 1, wherein the first and second segments are discrete from each other.

27. The apparatus according to claim 1, wherein:

the first segment has first and second ends that define first and second ends, respectively, of the first lumen,

the second segment has first and second ends that define first and second ends, respectively, of the second lumen, and

one end of the first segment is positioned corresponding to a nearest end of the second segment in a manner in which a logitudinal axis of the first lumen at the end of the first segment is disposed at a non-zero angle with respect to a longitudinal axis of the second lumen at the nearest end of the second segment, when the first and second slidable coupling arrangements facilitate control by the control wires of the relative dispositions of the first and second segments.

28. The apparatus according to claim 1, wherein:

the first segment has first and second ends that define first and second ends, respectively, of the first lumen,

the second segment has first and second ends that define first and second ends, respectively, of the second lumen, and

one end of the first segment is positioned corresponding to a nearest end of the second segment in a manner in which one end of the first lumen faces a nearest end of the second lumen.