ACCESS TO THE LEFT ATRIUM AND REDUCTION OF MITRAL VALVE LEAFLET MOBILITY

• US 20100298930A1
• Filed: 12/02/2008
• Published: 11/25/2010
• Est. Priority Date: 12/02/2007
• Status: Abandoned Application

• Current Assignee: Mor Research Applications Ltd. (Clalit Health Services)
• Original Assignee: Mor Research Applications Ltd. (Clalit Health Services)
• Inventors: Orlov, Boris
• Application Number:
  US12/745,700
• Publication Number:
  US 20100298930A1
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

Disclosed are a method for engaging cardiac valve leaflets, including a) directing a distal end of an elongated catheter body of a leaflet-engaging device into a coronary sinus of a heart, b) passing a first leaflet-engaging component located proximate to the distal end of the elongated catheter body of the leaflet-engaging device through cardiac tissue separating the coronary sinus and a left atrium of the heart to enter a left atrium of the heart, and c) engaging a first cardiac valve leaflet with the first leaflet-engaging component, thereby engaging at least one cardiac valve leaflet. Related apparatus and methods are also described.

Claims

1. A method for engaging mitral valve leaflets, comprising:

a) directing a distal end of an elongated catheter body of a leaflet-engaging device into a coronary sinus of a heart;

b) passing a first leaflet-engaging component located proximate to said distal end of said elongated catheter body of said leaflet-engaging device through cardiac tissue separating said coronary sinus and a left atrium of said heart to enter a left atrium of said heart; and

c) engaging a first mitral valve leaflet with said first leaflet-engaging component,

thereby engaging at least one mitral valve leaflet.

3. The method of claim 1, wherein said first leaflet-engaging component engages said mitral valve leaflet at an atrial face of said first mitral valve leaflet.

5. The method of claim 1, wherein said engaging of said first mitral valve leaflet comprises application of suction through said first leaflet-engaging component, and further comprising said first leaflet-engaging component sliding along a face of said first mitral valve leaflet.

8. The method of claim 1, further comprising engaging a second mitral valve leaflet.

11. The method of claim 8, wherein said engaging of said second mitral valve leaflet is with a second leaflet-engaging component located proximal to said distal end of said leaflet-engaging device, and wherein said second leaflet-engaging component engages said second mitral valve leaflet at an atrial face of said second mitral valve leaflet.

15. The method of claim 11, wherein said first leaflet-engaging component and said second leaflet-engaging component of said leaflet-engaging device are independently maneuverable, and further comprising:

moving said first leaflet-engaging component and said second leaflet-engaging component one relative to the other so as to change the relative orientation of said engaged first leaflet and said engaged second leaflet.

21. The method of claim 1, further comprising:

directing a second leaflet-engaging device to proximity of a second mitral valve leaflet; and

engaging a second mitral valve leaflet with said second leaflet-engaging device.

wherein said directing of said second leaflet-engaging device to proximity of said second mitral valve leaflet is through a left ventricle of said heart.

22. The method of claim 1, further comprising:

directing a second leaflet-engaging device to proximity of a second mitral valve leaflet; and

engaging a second mitral valve leaflet with said second leaflet-engaging device,

wherein said directing of said second leaflet-engaging device to proximity of said second mitral valve leaflet is through a left atrium of said heart.

2. (canceled)

4. (canceled)

6-7. -7. (canceled)

9-10. -10. (canceled)

12-14. -14. (canceled)

16-20. -20. (canceled)

23-26. -26. (canceled)

27. A device for engaging cardiac valve leaflets, comprising:

a) an elongated catheter body with a proximal end and a distal end, said distal end shaped for passage into a heart of a mammalian body; and

b) a first leaflet-engaging component located proximate to said distal end of said catheter body.

28. The device of claim 27 in which said first leaflet-engaging component comprises a suction device.

29. The device of claim 27 in which said distal end is at an angle of between about 70°

to 110°

to a longitudinal axis of said elongated catheter body, said angle located proximally to said distal end, and in which said angle is located at about 5 centimeters +/−

20% from said distal end.

32. The device of claim 27, wherein:

said elongated catheter body comprises a main lumen passing from a proximal end of said elongated catheter body and terminating at a port proximal to and at a side of said distal end of said elongated catheter body;

said first-leaflet-engaging component is configured to move into and out of said main lumen through said port; and

said first leaflet-engaging component is functionally associated with a first leaflet-engaging component director, said first leaflet-engaging component director passing from said proximal end to said distal end of said elongated catheter body and through said main lumen of said elongated catheter body, said first leaflet-engaging component director is configured so that manipulation of said first leaflet-engaging component director affects said moving of said first leaflet-engaging component into and out of said main lumen through said port.

33. The device of claim 27, wherein said first leaflet-engaging component comprises a suction port configured for communication with a vacuum source through a vacuum lumen passing through said elongated catheter body.

38. The device of claim 32, further comprising:

a reversible anchoring component proximate to said distal end of said elongated catheter body, said anchoring component having at least two states;

i) a first non-anchoring state; and

ii) a second anchoring state, wherein said anchoring component engages walls of a coronary sinus in which said distal end is located so as stabilize a position of said distal end in said coronary sinus; and

an anchoring component actuator functionally associated with said anchoring component, configured to allow changing of said anchoring component from said first non-anchoring state to said second anchoring state.

40. The device of claim 38, in which the reversible anchoring component envelops said elongated catheter body, and comprises a side opening allowing a component to move into and out of said elongated catheter body through said port and through said side opening.

41. The device of claim 38, wherein said anchoring component is configured to avoid complete obstruction of a lumen of said coronary sinus when in said second anchoring state.

48. A kit comprising the device of claim 27, and a separate, additional leaflet augmentation device for augmenting at least one mitral valve leaflet.

49. A kit comprising the device of claim 27, and a separate, additional cardiac valve obstructor for obstructing at least part of a cardiac valve.

30-31. -31. (canceled)

34-37. -37. (canceled)

39. (canceled)

42-47. -47. (canceled)

50. A device suitable for defining a minimally invasive conduit to a left atrium of a mammalian heart, comprising:

a) an elongated catheter body with a proximal end, a distal end and a distal tip, said distal end configured for passage into a coronary sinus from a peripheral region of a mammalian body;

b) a main lumen passing from said proximal end to said distal end of said elongated catheter body, said main lumen terminating at a side port located at a side of said distal end of said elongated catheter body;

c) a reversible anchoring component in proximity of said distal end of said elongated catheter body, said anchoring component having at least two states;

i) a first non-anchoring state; and

ii) a second anchoring state, wherein said anchoring component engages walls of a coronary sinus in which said distal end is located so as stabilize a position of said distal end in said coronary sinus; and

d) an anchoring component actuator functionally associated with said anchoring component, configured to allow changing of said anchoring component from said first non-anchoring state to said second anchoring state, wherein said anchoring component is configured to anchor on a side of said elongated catheter body opposite said side port.

51. The device of claim 50 and further comprising an elongated piercing component configured for passage through said main lumen from said proximal end to emerge out through said side port so as to puncture tissue proximate to said side port.

53. The device of claim 50, wherein said elongated catheter body is configured for passage of said distal end into a coronary sinus so that said side port faces a cardiac wall separating said coronary sinus from a left atrium.

54. The device of claim 53 in which said distal end is at an angle of between about 70°

to 110°

to a longitudinal axis of said elongated catheter body, said angle located proximally to said distal end, and in which said angle is located at about 5 centimeters +/−

20% from said distal end.

52. (canceled)

55. (canceled)

56. A method for defining a minimally invasive conduit to a left atrium of a mammalian heart, comprising:

a) providing a device including;

i) an elongated catheter body with a proximal end, a distal end and a distal tip, said distal end configured for passage into a coronary sinus from a peripheral region of a mammalian body; and

ii) a main lumen passing from said proximal end to said distal end of said elongated catheter body, said main lumen terminating at a side port located at a side of said distal end of said elongated catheter body;

b) directing said distal end of said elongated catheter body of said device into a coronary sinus of a heart so that said side port faces a cardiac wall separating said coronary sinus from a left atrium; and

c) passing an elongated piercing component through said side port so as to puncture said cardiac wall separating said coronary sinus from a left atrium.

60. The method of claim 56, further comprising:

pressing said side port against said cardiac wall separating said coronary sinus from said left atrium.

65. The method of claim 56 wherein said distal end of said elongated catheter body is configured to avoid complete obstruction of a lumen of said coronary sinus at least when in an anchoring state.

57-59. -59. (canceled)

61-64. -64. (canceled)