HEART VALVE REPAIR DEVICES AND METHODS

• US 20130006352A1
• Filed: 06/21/2012
• Published: 01/03/2013
• Est. Priority Date: 06/29/2011
• Status: Active Grant

• Current Assignee: Mitralix Ltd.
• Original Assignee: Mitralix Ltd.
• Inventors: YARON, Ira
• Granted Patent: US 9,364,326 B2
• Time in Patent Office: Days
• US Class Current: 623/2.37
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2310/00011 Metals or alloys

Abstract

Devices and methods for the repair of the functioning of heart valves are provided. A device may comprise a first section having a generally spiral shape and a second section connected to the first section. A method involves positioning the device such that chords associated with the heart valve are positioned within the path of the generally spiral shape of the first section and positioning the second section on an opposite side of the heart valve. The first section may be turned in a manner such that the chords move closer to the center of the first section. The first section draws the chords closer together, thereby pulling the valve leaflets closer together in order to facilitate their coaptation and proper closing.

Claims

1. A device for assisting the functioning of a heart valve comprising:

a first section having a generally spiral shape adapted to be positioned on a ventricular side of the heart valve such that chords associated with the heart valve are positioned within the path of the generally spiral shape of the first section; and

a second section adapted to be positioned on an atrial side of the heart valve;

wherein the first section is connected to the second section.

2. A device as in claim 1, wherein the first section is substantially flat.

3. A device as in claim 1, wherein the first section is substantially conical.

4. A device as in claim 1, wherein the generally spiral shape of the first section is substantially circular.

5. A device as in claim 1, wherein the generally spiral shape of the first section is substantially elliptical.

6. A device as in claim 1, wherein the second section has a generally spiral shape.

7. A device as in claim 6, wherein the second section is substantially flat.

8. A device as in claim 6, wherein the second section is substantially conical.

9. A device as in claim 6, wherein the generally spiral shape of the second section is substantially circular.

10. A device as in claim 6, wherein the generally spiral shape of the second section is substantially elliptical.

11. A device as in claim 1, further comprising a connector connecting the first section to the second section.

12. A device as in claim 11, wherein the connector is substantially straight.

13. A device as in claim 11, wherein the connector is curved.

14. A device as in claim 1, wherein the device, including the first section, comprises a wire, bundle of wires, strip, rod, tube or a combination thereof

15. A device as in claim 14, wherein the wire, bundle of wires, strip, rod or tube has a circular cross-section.

16. A device as in claim 14, wherein the wire, bundle of wires, strip, rod or tube has an elliptical cross-section.

17. A device as in claim 14, wherein the wire, bundle of wires, strip, rod or tube has a rectangular, square or other non-round cross-section.

18. A device as in claim 14, wherein the wire, bundle of wires, strip, rod or tube has different cross-sections at different places along its length.

19. A device as in claim 14, wherein at least one end of the wire, bundle of wires, strip, rod or tube is rounded.

20. A device as in claim 14, wherein the wire, bundle of wires, strip, rod or tube has a groove in its outer surface.

21. A device as in claim 20, wherein the groove in the outer surface of the wire, bundle of wires, strip, rod or tube extends around the perimeter of the wire, bundle of wires, strip, rod or tube.

22. A device as in claim 20, wherein the groove in the outer surface of the wire, bundle of wires, strip, rod or tube extends in the direction of the length of the wire, bundle of wires, strip, rod or tube.

23. A device as in claim 20, wherein the groove in the outer surface of the wire, bundle of wires, strip, rod or tube extends in a substantially helical path along the wire, bundle of wires, strip, rod or tube.

24. A device as in claim 14, wherein the wire, bundle of wires, strip, rod or tube has one or more holes.

25. A device as in claim 14, further comprising a coating on the wire, bundle of wires, strip, rod or tube.

26. A device as in claim 25, wherein the coating is a drug-release coating.

27. A device as in claim 1, wherein the device is comprised at least in part of a metallic material.

28. A device as in claim 1, wherein the device is comprised at least in part of a shape memory metal material.

29. A device as in claim 1, wherein the device is comprised at least in part of nitinol.

30. A device as in claim 1, wherein the device is comprised at least in part of a plastic material.

31. A device as in claim 1, wherein the device is comprised at least in part of a composite material.

32. A device as in claim 1, wherein the device further comprises at least one anchoring element for anchoring the device to heart tissue.

33. A device as in claim 1, wherein the device further comprises a sensor.

34. A device as in claim 33, wherein the sensor is at least one of a pressure sensor, a temperature sensor, or a velocity sensor.

35. A method of repairing a heart valve comprising:

delivering a heart valve assisting device to the area of the heart valve, the device comprising a first section having a generally spiral shape and a second section connected to the first section;

positioning the first section on a ventricular side of the heart valve such that chords associated with the heart valve are positioned within the path of the generally spiral shape of the first section; and

positioning the second section on an atrial side of the heart valve.

36. A method as in claim 35, wherein the step of positioning the first section comprises turning the first section in a first direction such that the chords move closer to the center of the first section.

37. A method as in claim 36, wherein the step of positioning the first section comprises positioning the first section such that chords associated with the anterior papillary muscle and chords associated with the posterior papillary muscle are positioned within the path of the generally spiral shape of the first section and wherein the turning of the first section in the first direction reduces a gap between chords associated with the anterior papillary muscle and chords associated with the posterior papillary muscle.

38. A method as in claim 36, wherein the step of positioning the first section comprises, after turning the first section in a first direction, turning the first section in a second direction such that the chords move further from the center of the first section, to adjust the positioning of the chords in the device.

39. A method as in claim 35, wherein the device, including the first section, is formed from a tube, and further comprising the step of inserting a stiffening element into the tube to increase the stiffness of the first section.

40. A method as in claim 35, wherein the step of delivering the heart valve assisting device to the area of the heart valve comprises delivering the device using a femoral approach.

41. A method as in claim 35, wherein the step of delivering the heart valve assisting device to the area of the heart valve comprises delivering the device using a transseptal approach.

42. A method as in claim 35, wherein the step of delivering the heart valve assisting device to the area of the heart valve comprises delivering the device using a transapical approach.

43. A method as in claim 35, wherein the step of delivering the heart valve assisting device to the area of the heart valve comprises using a delivery system including a catheter, and the step of positioning the first section of the device comprises using the delivery system to push the first section of the device from the catheter to the ventricular side of the heart valve.

44. A method as in claim 43, wherein the step of positioning the first section of the device comprises, after pushing the first section of the device from the catheter, using the delivery system to pull the first section of the device adjacent the heart valve.

45. A method as in claim 35, wherein the step of positioning the first section comprises using the delivery system to turn the first section in a first direction such that the chords move closer to the center of the first section.

46. A method as in claim 35, further comprising the step of using a delivery system to grasp the device and to withdraw the device.

47. A device for assisting the functioning of a heart valve comprising:

an annuloplasty device having a first diameter at which the annuloplasty device is configured to be anchored to an annulus of the heart valve;

wherein the annuloplasty device is configured for reduction in diameter after being anchored to the annulus in order the reduce the diameter of the annulus.

48. A device as in claim 47, wherein the annuloplasty device has an interior lumen and further comprising a deflecting element configured to be inserted into or removed from the interior lumen of the annuloplasty device in order to reduce the diameter of the annuloplasty device after the annuloplasty device is anchored to the annulus.

49. A device as in claim 47, further comprising a biodegradable coating configured to hold the annuloplasty device in the first diameter and wherein the biodegradable coating biodegrades after the annuloplasty device is anchored to the annulus in order to permit the reduction in diameter of the annuloplasty device.

50. A device as in claim 47, wherein the annuloplasty device has an interior lumen and further comprising a deflecting element in the interior lumen of the annuloplasty device wherein the deflecting element is configured to be pulled in order to reduce the diameter of the annuloplasty device after the annuloplasty device is anchored to the annulus.