Annuloplasty Device Having a Helical Anchor and Methods for its Use

• US 20070244553A1
• Filed: 04/12/2007
• Published: 10/18/2007
• Est. Priority Date: 04/12/2006
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Douk, Nareak, Rafiee, Nasser, Finney, Michael, Mas, Juan-Pablo, House, Morgan, Mac Donald, Stuart, Barone, David, Bloom, Eliot, Huynh, Rany
• Granted Patent: US 8,454,683 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

A system for modifying a heart valve annulus includes a helically helical anchored annuloplasty device delivered to the annulus via an elongated delivery member. The helical anchors of the devices disclosed herein are rotated into the valve annulus along an anchor guide by using a driver that is movably disposed in the delivery member. A tether is disposed within an inner channel of the helical anchor and a locking device is used to secure the annuloplasty device after the valve annulus has been modified. The annuloplasty device can be delivered to the annulus using, traditional surgical approach or a minimally invasive or catheter based methods.

Claims

1. A system for modifying a heart valve annulus, comprising:

at least one elongated, generally tubular delivery member having a delivery lumen, a distal end, and a proximal end;

at least one elongated driver having a distal end and a proximal end, the driver being movably inserted into the delivery lumen;

at least one anchor guide;

at least one helical anchor having a long axis, a distal end, a proximal end, and a plurality of coils, the proximal end of the at least one helical anchor being releasably connected to the distal end of the at least one driver;

the distal end of the at least one helical anchor having a sharpened tip portion

the coils of the at least one helical anchor defining an inner channel that communicates along the length of the helical anchor;

an elongated flexible tether having a first end and a second end, and the tether being insertable into the system such that one of the first end or the second end of the tether extends from the distal end of the delivery member and the other of the first end or the second end of the tether extends in a proximal direction from the proximal end of the delivery member.

2. The system of claim 1 wherein the at least one anchor guide is affixed to the distal end of the at least one delivery member and the at least one anchor guide is shaped to match the curvature of at least a portion of a heart valve annulus.

3. The system of claim 1 wherein the at least one anchor guide is an extension of the distal end of the at least one delivery member that extends beyond a distal opening of the delivery lumen and the at least one anchor guide is shaped to match the curvature of at least a portion of a heart valve annulus.

4. The system of claim 1 wherein the at least one driver is a generally tubular member with an anchor guide lumen communicating therethrough and the at least one anchor guide is an elongated flexible member that is inserted into the anchor guide lumen;

the anchor guide having a lumen for receiving the tether; and

the at least one anchor guide is movable between a delivery position within the guide lumen and a deployment position wherein the at least one anchor guide extends from the distal end of the at least one delivery member.

5. The system of claim 1 wherein the at least one delivery member further includes a tether lumen extending along at least a portion thereof, the tether lumen having a distal opening located adjacent the distal end of the at least one delivery member and a proximal opening located distal to the proximal end of the at least one delivery member and the tether is insertable into the tether lumen.

6. The system of claim 1 further comprising means for releasably connecting the at least one helical anchor to the distal end of the at least one driver.

7. The system of claim 6 wherein the distal end of the at least one driver includes a helical anchor receiving portion for releasably holding the at least one helical anchor and the at least one helical anchor includes a driver portion for insertion into the helical anchor receiving portion.

8. The system of claim 1 wherein a portion of the distal end of the at least one delivery member is movable between a substantially linear insertion configuration and curved delivery configuration.

9. The system of claim 1 wherein the at least one anchor guide portion is a flexible steerable member having a lumen for receiving the tether.

10. The system of claim 1 further comprising a handle mounted on the proximal end of the at least one delivery member, and a torque knob on the proximal end of the at least one driver.

11. The system of claim 1 wherein the at least one delivery member comprises a plurality of delivery members, the at least one driver comprises a plurality of drivers, the at least one anchor guide comprises a plurality of anchor guides, and the at least one helical anchor comprises a plurality of helical anchors.

12. The system of claim 1 wherein the at least one helical anchor comprises a plurality of helical anchors.

13. The system of claim 1 wherein the at least one anchor guide comprises a plurality of anchor guides;

and

wherein each of the plurality of anchor guides has a shape that matches a specific portion of a heart valve annulus.

14. The system of claim 1 wherein the at least one driver is rotatably and axially movable within the at least one delivery member to drive the at least one helical anchor through a heart valve annulus along the at least one anchor guide.

15. The system of claim 1 further comprising means for securing the first end and second end of the tether such that the tether forms a loop.

16. The system of claim 15 wherein the means for securing the first end and second end of the tether is a snell knot.

17. The system of claim 15 wherein the means for securing the first end and second end of the tether is at least one stop member that has a size and shape such that it cannot pass through the inner channel of the at least one helical anchor;

the at least one stop member having at least one tether channel passing therethrough; and

the tether further comprising a plurality of locking members spaced along at least a portion thereof.

18. The system of claim 17 wherein the at least one stop member having at least one tether channel is a single stop member having two tether channels.

19. The system of claim 17 wherein the at least one stop member having at least one tether channel is two stop members, each having a single tether channel.

20. A system for modifying a heart valve annulus, comprising:

an elongated, generally tubular delivery member having a delivery lumen, a distal end, and a proximal end;

an elongated driver having a distal end and a proximal end, the driver being movably inserted into the delivery lumen;

an anchor guide;

a helical anchor having a long axis, a distal end, a proximal end, and a plurality of coils, the proximal end of the at least one helical anchor being releasably connected to the distal end of the at least one driver;

the distal end of the helical anchor having a sharpened tip portion

the coils of the helical anchor defining an inner channel that communicates along the length of the helical anchor;

an elongated flexible tether having a first end and a second end, and the tether being insertable into the system such that one of the first end or the second end of the tether extends from the distal end of the delivery member and the other of the first end or the second end of the tether extends in a proximal direction from the proximal end of the delivery member.

21. The system of claim 20 wherein the anchor guide is affixed to the distal end of the delivery member and the anchor guide is shaped to match the curvature of at least a portion of a heart valve annulus.

22. The system of claim 20 wherein the anchor guide is an extension of the distal end of the delivery member that extends beyond a distal opening of the delivery lumen and the anchor guide is shaped to match the curvature of at least a portion of a heart valve annulus.

23. The system of claim 20 wherein the driver is a generally tubular member with an anchor guide lumen communicating therethrough and the anchor guide is an elongated flexible member that is inserted into the anchor guide lumen;

the anchor guide having a lumen for receiving the tether; and

the at least one anchor guide is movable between a delivery position within the guide lumen and a deployment position wherein the at least one anchor guide extends from the distal end of the at least one delivery member.

24. The system of claim 20 wherein the delivery member further includes a tether lumen extending along at least a portion thereof, the tether lumen having a distal opening located adjacent the distal end of the delivery member and a proximal opening located distal to the proximal end of the delivery member and the tether is insertable into the tether lumen.

25. The system of claim 20 further comprising means for releasably connecting the at least one helical anchor to the distal end of the at least one driver.

26. The system of claim 25 wherein the distal end of the driver includes a helical anchor receiving portion for releasably holding the helical anchor and the helical anchor includes a driver portion for insertion into the helical anchor receiving portion.

27. The system of claim 20 wherein a portion of the distal end of the delivery member is movable between a substantially linear insertion configuration and curved delivery configuration.

28. The system of claim 20 wherein the anchor guide portion is a flexible steerable member having a lumen for receiving a tether.

29. The system of claim 20 further comprising a handle mounted on the proximal end of the delivery member, and a torque knob on the proximal end of the driver.

30. The system of claim 20 wherein the delivery member comprises a plurality of delivery members, the driver comprises a plurality of drivers, the anchor guide comprises a plurality of anchor guides, and the helical anchor comprises a plurality of helical anchors.

31. The system of claim 20 wherein the helical anchor comprises a plurality of helical anchors.

32. The system of claim 20 wherein the anchor guide comprises a plurality of anchor guides;

and

wherein each of the plurality of anchor guides has a shape that matches a specific portion of a heart valve annulus.

33. The system of claim 20 wherein the driver is rotatably and axially movable within the delivery member to drive the helical anchor through a heart valve annulus along the anchor guide.

34. The system of claim 20 further comprising means for securing the first end and second end of the tether such that the tether forms a loop.

35. The system of claim 34 wherein the means for securing the first end and second end of the tether is a snell knot.

36. The system of claim 34 wherein the means for securing the first end and second end of the tether is at least one stop member that has a size and shape such that it cannot pass through the inner channel of the helical anchor;

the stop member having at least one tether channel passing therethrough; and

the tether further comprising a plurality of locking members spaced along at least a portion thereof.

37. The system of claim 36 wherein the stop member having at least one tether channel is a single stop member having two tether channels.

38. The system of claim 36 wherein the stop member having at least one tether channel is two stop members, each having a single tether channel.

39. A device for altering the shape of a heart valve annulus comprising:

at least one helical anchor having a long axis, a distal end, a proximal end, and a plurality of coils;

the distal end of the at least one helical anchor having a sharpened tip portion

the coils of the at least one helical anchor defining an inner channel that communicates along the length of the helical anchor;

an elongated flexible tether having a first end and a second end, and the tether being insertable into the inner channel of the at least one helical anchor.

40. The device of claim 39 further comprising means for securing the first end and second end of the tether such that the tether forms a loop.

41. The device of claim 40 wherein the means for securing the first end and second end of the tether is a snell knot.

42. The device of claim 40 wherein the means for securing the first end and second end of the tether is at least one stop member that has a size and shape such that it cannot pass through the inner channel of the at least one helical anchor;

the at least one stop member having at least one tether channel passing therethrough; and

the tether further comprising a plurality of locking members spaced along at least a portion thereof.

43. The device of claim 42 wherein the at least one stop member having at least one tether channel is a single stop member having two tether channels.

44. The system of claim 42 wherein the at least one stop member having at least one tether channel is two stop members, each having a single tether channel.