Implantation of repair chords in the heart

• US 8,252,050 B2
• Filed: 09/21/2009
• Issued: 08/28/2012
• Est. Priority Date: 12/22/2008
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Maisano, Francesco, Miller, Eran, Cabiri, Oz, Herman, Yaron, Weitzman, Yoseph, Gross, Yossi, Sheps, Tal
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US12/563,952
• Publication Number:
  US 20100161043A1
• Time in Patent Office: 1,072 Days
• Field of Search: 606/108, 606139-150, 606/213, 606/232, 623/2.11, 623/2.36, 623/2.37, 623/2.39, 623/23.72
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

Apparatus is provided for adjusting at least one dimension of an implant, including a rotatable structure having first and second openings and a channel extending between the first and second openings. The channel allows passage therethrough of an elongate tool. The second end of the structure has a lower surface having one or more recesses along a circumference thereof. A mechanical element provides a protrusion that is disposed within one of the recesses of the rotatable structure during a resting state of the mechanical element, in a manner that restricts rotation of the rotatable structure. The mechanical element includes a depressible portion coupled to the protrusion disposed in communication with the second opening of the lower surface, and configured to dislodge the protrusion from within the recess in response to a force applied thereto by the elongate tool. Other applications are also described.

Claims

1. Apparatus, comprising:

a rotatable structure having a first end shaped to define a first opening, and a second end shaped to define a second opening, the rotatable structure being shaped to define a channel extending from the first opening to the second opening, the channel being configured for passage therethrough of an elongate tool, and the second end of the rotatable structure having a lower surface thereof shaped to define one or more recesses;

a mechanical element having a surface coupled to the lower surface of the rotatable structure, the mechanical element being shaped to provide;

a protrusion protruding out of a plane of the surface of the mechanical element, the protrusion being disposed within one of the recesses during a resting state of the mechanical element, in a manner that restricts rotation of the rotatable structure, and

a depressible portion coupled to the protrusion, the depressible portion being disposed in communication with the second opening of the second end, and configured to dislodge the protrusion from within the recess in response to a force applied to the depressible portion by the elongate tool; and

a flexible, longitudinal member having first and second end portions thereof, at least the first end portion of the longitudinal member being coupled to the rotatable structure in a manner in which, as a result of rotation of the rotatable structure;

the first end portion of the longitudinal member advances with respect to the rotatable structure, and

a configuration of the longitudinal member changes,

wherein;

the longitudinal member comprises an implant comprising an artificial chorda tendinea, and the apparatus is for adjusting at least one dimension of the implant,

the rotatable structure is implantable at a first portion of tissue facing a ventricular lumen of a ventricle of a patient,

the second end portion of the longitudinal member is couplable to at least one leaflet of an atrioventricular valve of the patient, and

the rotatable structure is rotatable to advance the first end portion of the longitudinal member with respect to the rotatable structure, in a manner which alters a distance between the second end portion of the longitudinal member and the rotatable structure.

2. The apparatus according to claim 1,

wherein, during a first period:

the elongate tool is configured to maintain the protrusion in a position in which it is dislodged from the recess, and

the elongate tool is configured to rotate the rotatable structure, and

wherein, during a second period;

the elongate tool is removable from the channel to position the protrusion in the recess, and

the rotatable structure is restricted from being rotated.

3. The apparatus according to claim 2, wherein during the first period, the rotatable structure is rotatable in first and second directions, the first direction being opposite the second direction.

4. The apparatus according to claim 1, further comprising a housing surrounding the rotatable structure, the housing being coupled in part to a cap having a surface that is disposed in parallel with the lower surface of the rotatable structure, wherein the depressible portion is disposed between the lower surface of the rotatable structure and the cap, and wherein the cap is shaped to define a recessed portion thereof configured to receive the depressible portion during a depressed state of the depressible portion.

5. The apparatus according to claim 1, further comprising a housing surrounding the rotatable structure, the housing being shaped to define a recessed portion thereof configured to receive the protrusion during the resting state of the mechanical element.

6. The apparatus according to claim 1, further comprising a tissue anchor, wherein the rotatable structure is coupled to the tissue anchor, and wherein the rotatable structure is implantable at an intraventricular site such that the tissue anchor does not extend beyond a pericardium of a heart of the patient.

7. Apparatus, comprising:

a rotatable structure having a first end shaped to define a first opening, and a second end shaped to define a second opening, the rotatable structure being shaped to define a channel extending from the first opening to the second opening, the channel being configured for passage therethrough of an elongate tool, and the second end of the rotatable structure having a lower surface thereof shaped to define one or more recesses;

a mechanical element having a surface coupled to the lower surface of the rotatable structure, the mechanical element being shaped to provide;

a protrusion protruding out of a plane of the surface of the mechanical element, the protrusion being disposed within one of the recesses during a resting state of the mechanical element, in a manner that restricts rotation of the rotatable structure, and

a depressible portion coupled to the protrusion, the depressible portion being disposed in communication with the second opening of the second end, and configured to dislodge the protrusion from within the recess in response to a force applied to the depressible portion by the elongate tool; and

a flexible, longitudinal member having first and second end portions thereof, at least the first end portion of the longitudinal member being coupled to the rotatable structure in a manner in which, as a result of rotation of the rotatable structure;

the first end portion of the longitudinal member advances with respect to the rotatable structure, and

a configuration of the longitudinal member changes,

wherein;

the apparatus comprises an annuloplasty device having at least one end portion,

the annuloplasty device comprises an implant, and the apparatus is for adjusting at least one dimension of the implant,

the rotatable structure is coupled to the annuloplasty device,

the longitudinal member is coupled at the second end portion thereof to the at least one end portion of the annuloplasty device, and

the rotatable structure is rotatable to advance the first end portion of the longitudinal member with respect to the rotatable structure in a manner which alters a distance between the second end portion of the longitudinal member and the rotatable structure.

8. The apparatus according to claim 7,

wherein, during a first period:

the elongate tool is configured to maintain the protrusion in a position in which it is dislodged from the recess, and

the elongate tool is configured to rotate the rotatable structure, and

wherein, during a second period;

the elongate tool is removable from the channel to position the protrusion in the recess, and

the rotatable structure is restricted from being rotated.

9. The apparatus according to claim 8, wherein during the first period, the rotatable structure is rotatable in first and second directions, the first direction being opposite the second direction.

10. The apparatus according to claim 7, further comprising a housing surrounding the rotatable structure, the housing being coupled in part to a cap having a surface that is disposed in parallel with the lower surface of the rotatable structure, wherein the depressible portion is disposed between the lower surface of the rotatable structure and the cap, and wherein the cap is shaped to define a recessed portion thereof configured to receive the depressible portion during a depressed state of the depressible portion.

11. The apparatus according to claim 7, further comprising a housing surrounding the rotatable structure, the housing being shaped to define a recessed portion thereof configured to receive the protrusion during the resting state of the mechanical element.

12. Apparatus for adjusting at least one dimension of an implant, comprising:

a rotatable structure having a first end shaped to define a first opening, and a second end shaped to define a second opening, the rotatable structure being shaped to define a channel extending from the first opening to the second opening, the channel being configured for passage therethrough of an elongate tool, and the second end of the rotatable structure having a lower surface thereof shaped to define one or more recesses;

a mechanical element having a surface coupled to the lower surface of the rotatable structure, the mechanical element being shaped to provide;

a protrusion protruding out of a plane of the surface of the mechanical element, the protrusion being disposed within one of the recesses during a resting state of the mechanical element, in a manner that restricts rotation of the rotatable structure, and

a depressible portion coupled to the protrusion, the depressible portion being disposed in communication with the second opening of the second end, and configured to dislodge the protrusion from within the recess in response to a force applied to the depressible portion by the elongate tool; and

a flexible, longitudinal member having first and second end portions thereof, at least the first end portion of the longitudinal member being coupled to the rotatable structure in a manner in which, as a result of rotation of the rotatable structure;

the first end portion of the longitudinal member advances with respect to the rotatable structure, and

a configuration of the longitudinal member changes,

wherein the rotatable structure comprises a spool, and

wherein the longitudinal member is coupled at at least the first end portion thereof to the spool and is wrapped around the spool in response to rotation of the spool in a first direction.

13. The apparatus according to claim 12, wherein the lower surface is shaped to provide at least a portion thereof having a circumference, and wherein the one or more recesses are disposed along the circumference.

14. The apparatus according to claim 12, wherein the first end portion of the longitudinal member is reversibly coupled to the spool.

15. The apparatus according to claim 12, wherein:

the longitudinal member defines the implant,

the second end portion of the longitudinal member is couplable to a portion of tissue of a heart of a patient, and

the spool is rotatable to advance the first end portion of the longitudinal member with respect to the spool, in a manner which alters a distance between the second end portion of the longitudinal member and the spool.

16. The apparatus according to claim 12,

wherein, during a first period:

the elongate tool is configured to maintain the protrusion in a position in which it is dislodged from the recess, and

the elongate tool is configured to rotate the spool, and

wherein, during a second period;

the elongate tool is removable from the channel to position the protrusion in the recess, and

the spool is restricted from being rotated.

17. The apparatus according to claim 16, wherein during the first period, the spool is rotatable in first and second directions, the first direction being opposite the second direction.

18. The apparatus according to claim 12,

wherein the spool is configured for implantation in a first portion of heart tissue that defines a ventricular lumen of a ventricle of a patient,

wherein the longitudinal member is couplable at the second end portion thereof to a second portion of heart tissue that defines the ventricular lumen of the ventricle of the patent, and

wherein, in response to rotation of the spool in a first direction thereof, the longitudinal member is configured to be wound around the spool, and, responsively, to shorten a distance between the second end portion of the longitudinal member and the spool.

19. The apparatus according to claim 12, further comprising a housing surrounding the spool, the housing being coupled in part to a cap having a surface that is disposed in parallel with the lower surface of the spool, wherein the depressible portion is disposed between the lower surface of the spool and the cap, and wherein the cap is shaped to define a recessed portion thereof configured to receive the depressible portion during a depressed state of the depressible portion.

20. The apparatus according to claim 12, further comprising a housing surrounding the spool, the housing being shaped to define a recessed portion thereof configured to receive the protrusion during the resting state of the mechanical element.

21. A method for adjusting at least one dimension of an implant, comprising:

providing a rotatable structure including a spool, the spool having a first end shaped to define a first opening, and a second end shaped to define a second opening, the spool being shaped to define a channel extending from the first opening to the second opening, the channel being configured for passage therethrough of an elongate tool, and the second end of the spool having a lower surface thereof shaped to define one or more recesses, the spool and being coupled to;

a mechanical locking element having a surface coupled to a lower surface of the spool, the mechanical element being shaped to provide;

a protrusion protruding out of a plane of the surface of the mechanical element, the protrusion being disposed within one of the recesses during a resting state of the mechanical element, in a manner that restricts rotation of the spool, and

a depressible portion coupled to the protrusion, the depressible portion being disposed in communication with the second opening of the second end, and configured to dislodge the protrusion from within the recess in response to a force applied to the depressible portion by the elongate tool, and

a flexible, longitudinal member having first and second end portions thereof, at least the first end portion of the longitudinal member being coupled to the spool in a manner in which, as a result of rotation of the spool in a first direction;

the first end portion of the longitudinal member advances with respect to and is wrapped around the spool, and

a configuration of the longitudinal member changes;

implanting the spool in cardiac tissue;

advancing an elongate tool through a channel provided by the spool;

unlocking the spool from the mechanical locking element by pushing the depressible portion of the surface of the locking element;

responsively to the pushing of the depressible portion, dislodging a protrusion protruding out of a plane of the surface of the mechanical element from within a recess defined by the spool; and

in response to the dislodging, rotating the spool.

22. The method according to claim 21, wherein the spool is coupled to a tissue anchor, and wherein implanting the spool in the cardiac tissue comprises implanting the spool at an intraventricular site, such that the tissue anchor does not extend beyond a pericardium of a heart of the patient.

23. The method according to claim 21,

wherein rotating the spool comprises, during a first period,

facilitating the rotating of the spool by:

pushing the depressible portion; and

maintaining the protrusion in a position in which it is dislodged from the recess, and

wherein the method further comprises, during a second period;

removing the elongate tool from within the channel and facilitating positioning of the protrusion in the recess; and

restricting rotation of the spool.

24. The method according to claim 21, wherein rotating the spool comprises rotating the spool in first and second directions, the first direction being opposite the second direction.

25. The method according to claim 21, wherein rotating the spool comprises rotating the spool in a first direction, and wherein the method further comprises advancing the first end portion of the longitudinal member in a first direction with respect to the spool, responsively to the rotating of the spool in the first direction.

26. The method according to claim 25, further comprising:

rotating the spool in a second direction; and

responsively to the rotating of the spool in the second direction, advancing the first end portion of the longitudinal member in a second direction with respect to the spool, the second direction being opposite the first direction.

27. The method according to claim 25, wherein:

the longitudinal member adjusts at least one dimension of an implant including an annuloplasty device,

the second end portion of the longitudinal member is coupled to at least one end portion of the annuloplasty device, the end portion being selected from the group consisting of;

a first end portion of the annuloplasty device and a second end portion of the annuloplasty device, and

the method further comprises adjusting the at least one dimension of the implant responsively to the rotating by altering a distance between the second end portion of the longitudinal member and the spool.

28. The method according to claim 25, wherein advancing the first end portion of the longitudinal member in the first direction comprises wrapping at least a portion of the first end portion of the longitudinal member around the spool.

29. The method according to claim 28, further comprising:

rotating the spool in a second direction opposite the first direction; and

unwrapping the at least a portion of the first end portion of the longitudinal member from around the spool.

30. The method according to claim 25, further comprising coupling the second end portion of the longitudinal member to a portion of tissue of a heart of a patient, and wherein advancing the first end portion of the longitudinal member comprises drawing the portion of tissue and the spool toward each other.

31. The method according to claim 30, wherein coupling the second end portion of the longitudinal member to the portion of tissue of the heart of the patient comprises coupling the second end portion of the longitudinal member to at least one leaflet of an atrioventricular valve of the patient, and wherein advancing the first end portion of the longitudinal member comprises drawing the at least one leaflet and the spool toward each other.

32. A method for adjusting at least one dimension of an implant, comprising:

providing a rotatable structure having a first end shaped to define a first opening, and a second end shaped to define a second opening, the rotatable structure being shaped to define a channel extending from the first opening to the second opening, the channel being configured for passage therethrough of an elongate tool, and the second end of the rotatable structure having a lower surface thereof shaped to define one or more recesses, the rotatable structure being coupled to;

a mechanical locking element having a surface coupled to a lower surface of the rotatable structure, the mechanical element being shaped to provide;

a protrusion protruding out of a plane of the surface of the mechanical element, the protrusion being disposed within one of the recesses during a resting state of the mechanical element, in a manner that restricts rotation of the rotatable structure, and

a depressible portion coupled to the protrusion, the depressible portion being disposed in communication with the second opening of the second end, and configured to dislodge the protrusion from within the recess in response to a force applied to the depressible portion by the elongate tool, and

a flexible, longitudinal member defining the implant, the flexible, longitudinal member including an artificial chorda tendineae, the longitudinal member having first and second end portions thereof, at least the first end portion of the longitudinal member being coupled to the rotatable structure in a manner in which, as a result of rotation of the rotatable structure;

the first end portion of the longitudinal member advances with respect to and is wrapped around the rotatable structure, and

a configuration of the longitudinal member changes;

implanting the rotatable structure at a first portion of tissue facing a ventricular lumen of a ventricle of a patient;

coupling the second end portion of the longitudinal member to at least one leaflet of an atrioventricular valve of the patient; and

altering a distance between the second end portion of the longitudinal member and the rotatable structure by rotating the rotatable structure to advance the first end portion of the longitudinal member with respect to the rotatable structure.

33. The method according to claim 32, wherein the rotatable structure is coupled to a tissue anchor, and wherein implanting the rotatable structure comprises implanting the rotatable structure at an intraventricular site, such that the tissue anchor does not extend beyond a pericardium of a heart of the patient.

34. The method according to claim 32,

wherein rotating the rotatable structure comprises, during a first period, facilitating the rotating of the rotatable structure by:

pushing the depressible portion; and

maintaining the protrusion in a position in which it is dislodged from the recess, and

wherein the method further comprises, during a second period;

removing the elongate tool from within the channel and facilitating positioning of the protrusion in the recess; and

restricting rotation of the rotatable structure.

35. The method according to claim 32, wherein rotating the rotatable structure comprises rotating the rotatable structure in first and second directions, the first direction being opposite the second direction.

36. A method for adjusting at least one dimension of an implant, comprising:

providing a rotatable structure having a first end shaped to define a first opening, and a second end shaped to define a second opening, the rotatable structure being shaped to define a channel extending from the first opening to the second opening, the channel being configured for passage therethrough of an elongate tool, and the second end of the rotatable structure having a lower surface thereof shaped to define one or more recesses, the rotatable structure being coupled to;

a mechanical locking element having a surface coupled to a lower surface of the rotatable structure, the mechanical element being shaped to provide;

a protrusion protruding out of a plane of the surface of the mechanical element, the protrusion being disposed within one of the recesses during a resting state of the mechanical element, in a manner that restricts rotation of the rotatable structure, and

a depressible portion coupled to the protrusion, the depressible portion being disposed in communication with the second opening of the second end, and configured to dislodge the protrusion from within the recess in response to a force applied to the depressible portion by the elongate tool, and

a flexible, longitudinal member having first and second end portions thereof, at least the first end portion of the longitudinal member being coupled to the rotatable structure in a manner in which, as a result of rotation of the rotatable structure;

the first end portion of the longitudinal member advances with respect to and is wrapped around the rotatable structure, and

a configuration of the longitudinal member changes;

implanting in a body of a patient an annuloplasty device defining the implant, the annuloplasty device;

having at least one end portion

being coupled to the rotatable structure, and

being coupled at the at least one end portion thereof to the second end portion of the longitudinal member; and

altering a distance between the second end portion of the longitudinal member and the rotatable structure by rotating the rotatable structure to advance the first end portion of the longitudinal member with respect to the rotatable structure.

37. The method according to claim 36,

wherein rotating the rotatable structure comprises, during a first period, facilitating the rotating of the rotatable structure by:

pushing the depressible portion; and

maintaining the protrusion in a position in which it is dislodged from the recess, and

wherein the method further comprises, during a second period;

removing the elongate tool from within the channel and facilitating positioning of the protrusion in the recess; and

restricting rotation of the rotatable structure.

38. The method according to claim 36, wherein rotating the rotatable structure comprises rotating the rotatable structure in first and second directions, the first direction being opposite the second direction.