Adjustable repair chords and spool mechanism therefor

• US 8,147,542 B2
• Filed: 05/04/2009
• Issued: 04/03/2012
• 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
• Primary Examiner(s): Tyson, Melanie
• Application Number:
  US12/435,291
• Publication Number:
  US 20100161041A1
• Time in Patent Office: 1,065 Days
• Field of Search: 623/2.11, 606/139, 606144-150, 606/232
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• 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: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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

Abstract

A method and device is provided, including implanting, at an intraventricular site of a ventricle of a patient, a spool coupled to a first end portion of a longitudinal member, and coupling a second end portion of the longitudinal member to a portion of tissue facing a lumen of the ventricle. Other embodiments are also described.

Claims

1. Apparatus, comprising:

a delivery tool comprising;

a handle portion defining a handle lumen; and

a shaft (a) being slidable with respect to the handle portion, and (b) having a proximal portion thereof being slidable into the handle lumen during proximal sliding of the shaft;

a spool reversibly couplable to a distal end of the delivery tool and configured to be positioned in an intraventricular site of a ventricle of a patient, wherein;

the spool has 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 rotation tool, and

the second end of the spool has a lower surface thereof shaped to define one or more recesses at locations along a circumference; and

at least one longitudinal member having opposite first and second end portions, the first end portion being coupled to the spool and the second end portion configured to be coupled to a first portion of heart tissue that surrounds a ventricular space of the ventricle of the patient, the longitudinal member;

configured to be wound around the spool in response to rotation of the spool in a first direction thereof, and, responsively, to draw the second end portion of the longitudinal member and the first portion of heart tissue toward the first end portion of the longitudinal member.

2. The apparatus according to claim 1, wherein the shaft is shaped to provide at least one shaft lumen configured for housing a section of the longitudinal member that is between the first and second end portions thereof.

3. The apparatus according to claim 1, wherein the longitudinal member comprises expanded polytetrafluoroethylene (ePTFE).

4. The apparatus according to claim 1, wherein at least a portion of the longitudinal member is shaped to define a coil, and wherein the coil is configured to apply a tensioning force to the first portion of heart tissue.

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

6. The apparatus according to claim 1, further comprising a locking mechanism coupled to the spool and configured to restrict rotation of the spool.

7. The apparatus according to claim 1, further comprising at least one guide wire coupled to the spool, and wherein, subsequently to the positioning of the spool, the delivery tool is configured to be:

decoupled from the spool and removed from the ventricle, and

advanceable along the guide wire.

8. The apparatus according to claim 7, wherein the spool is configured to be implanted at the intraventricular site, and wherein the guide wire is configured to facilitate access of a torque-delivering-tool to the spool following the implantation of the spool at the intraventricular site.

9. The apparatus according to claim 1, further comprising a torque-delivering-tool, wherein:

the shaft is shaped to define at least a primary shaft lumen,

the torque-delivering-tool is coupled at a proximal end thereof to the handle portion and is disposed in the primary shaft lumen, and

the shaft is slidable with respect to the torque-delivering-tool.

10. The apparatus according to claim 9, wherein the delivery tool is configured to be advanceable between leaflets of an atrioventricular valve of the patient, and wherein the shaft is slidable with respect to the torque-delivering-tool in a manner that reduces a diameter of a portion of the delivery tool that is disposed between the leaflets of the valve.

11. The apparatus according to claim 9, wherein the handle lumen has a handle-lumen-length of between 50 mm and 100 mm, and wherein the shaft is slidable in a proximal direction to advance the proximal portion thereof into the handle lumen.

12. The apparatus according to claim 11, wherein a distal portion of the torque-delivering-tool is configured to be positioned within the ventricular space of the heart and defines a torque-delivering-tool-length at the distal portion of between 50 mm and 100 mm, and wherein a ratio of the handle-lumen-length and the torque-delivering-tool-length at the distal portion is between 0.7:

1 and 1.3;

1.

13. The apparatus according to claim 1, wherein:

the first portion of heart tissue includes an atrioventricular valve having at least first and second leaflets thereof,

the at least one longitudinal member comprises at least first and second longitudinal member portions having respective first and second end portions thereof,

the first end portions of the first and second longitudinal member portions are coupled to the spool,

the second end portion of the first longitudinal member portion is configured to be coupled to the first leaflet of the valve,

the second end portion of the second longitudinal member portion is configured to be coupled to the second leaflet of the valve, and

in response to rotation of the spool, the first and second longitudinal member portions are tightened and pull on the respective second end portions thereof toward the spool.

14. The apparatus according to claim 13, wherein in response to rotation of the spool in the first direction, the respective first end portions of the first and second longitudinal member portions are configured to be wound around the spool, and, responsively, to pull the respective second end portions of the first and second longitudinal member portions toward the spool, and responsively to draw the first and second leaflets toward each other.

15. The apparatus according to claim 1, further comprising a mechanical element having a surface coupled to the 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 lower surface, and configured to dislodge the protrusion from within the recess in response to a force applied thereto by the elongate rotation tool.

16. The apparatus according to claim 15, 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, and wherein the depressible portion is disposed between the lower surface of the spool and the cap.

17. The apparatus according to claim 15, 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.

18. The apparatus according to claim 15, further comprising a torque-delivering-tool disposed within a primary lumen of the shaft, wherein the torque-delivering tool is coupled at a distal end thereof to the elongate rotation tool, and wherein the torque-delivering-tool is configured to facilitate rotation of the spool by facilitating rotation of the elongate rotation tool.

19. The apparatus according to claim 18, wherein:

during a first period;

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

the torque-delivering-tool is configured to rotate the spool, and during a second period;

the torque-delivering-tool is configured to remove the elongate rotation tool from the channel and thereby to position the protrusion in the recess, and

in response to the positioning, the spool is restricted from being rotated.

20. The apparatus according to claim 1, wherein:

the at least one longitudinal member comprises at least first and second longitudinal members having respective first and second end portions thereof,

the first end portions of the first and second longitudinal members are coupled to the spool,

the second end portion of the first longitudinal member is configured to be coupled to a first portion of tissue of an inner wall of the ventricle,

the second end portion of the second longitudinal member is configured to be coupled to a second portion of tissue of the inner wall of the ventricle, and

in response to rotation of the spool, the first and second longitudinal members are tightened and pull the first and second portions of tissue of the inner wall toward one other.

21. The apparatus according to claim 1, further comprising an elongate tube coupled at a first end to the spool and configured, at a second end thereof, to be coupled to subcutaneous tissue of the patient, wherein the elongate tube is configured to facilitate accessing of a torque-delivering-tool to the spool following (a) the positioning of the spool at the intraventricular site and (b) subsequent removal of the delivery tool.

22. The apparatus according to claim 1, wherein:

the intraventricular site comprises a second portion of heart tissue that surrounds the ventricular space,

the spool is configured to be coupled to the second portion of heart tissue that surrounds the ventricular space, and

in response to the rotation of the spool, the longitudinal member is configured to draw the first and second portions of heart tissue toward each other.

23. The apparatus according to claim 22, wherein:

the first portion of heart tissue includes a first portion of an inner wall of the ventricle,

the second end portion of the longitudinal member is configured to be coupled to the first portion of the inner wall of the ventricle, and

in response to the rotation of the spool, the longitudinal member is configured to draw the first portion of the inner wall of the ventricle toward the second portion of heart tissue.

24. The apparatus according to claim 23, wherein:

the second portion of heart tissue includes a papillary muscle of the ventricle,

the spool is configured to be coupled to the papillary muscle, and

in response to the rotation of the spool, the longitudinal member is configured to draw the first portion of the inner wall of the ventricle toward the papillary muscle.

25. The apparatus according to claim 23, wherein:

the second portion of heart tissue includes a second portion of the inner wall of the ventricle,

the spool is configured to be coupled to the second portion of the inner wall of the ventricle, and

in response to the rotation of the spool, the longitudinal member is configured to draw the first and second portions of the inner wall of the ventricle toward one other.

26. The apparatus according to claim 22, wherein:

the first portion of heart tissue includes a leaflet of an atrioventricular valve of the patient,

the second end portion of the longitudinal member is configured to be coupled to the leaflet of the atrioventricular valve of the patient,

the second portion of heart tissue includes tissue of a papillary muscle of the ventricle,

the spool is configured to be implanted in the tissue of the papillary muscle of the ventricle, and

the spool is configured to adjust a length of the longitudinal member between the papillary muscle and the leaflet of the atrioventricular valve.

27. The apparatus according to claim 22, wherein:

the first portion of heart tissue includes a leaflet of an atrioventricular valve of the patient,

the second end portion of the longitudinal member is configured to be coupled to the leaflet of the atrioventricular valve of the patient,

the second portion of heart tissue includes a second portion of an inner wall of the ventricle,

the spool is configured to be coupled to the second portion of the inner wall of the ventricle, and

the spool is configured to adjust a length of the longitudinal member between the second portion of the inner wall and the leaflet of the atrioventricular valve.