Method and apparatus for circulatory valve repair

• US 20040199183A1
• Filed: 04/28/2004
• Published: 10/07/2004
• Est. Priority Date: 06/27/1997
• Status: Active Grant

• Current Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Original Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Inventors: Levin, Howard R., Allen, William, Oz, Mehmet C., Lemole, Gerald M., Umana, Juan P., Lotvin, Alan
• Granted Patent: US 7,464,712 B2
• Time in Patent Office: Days
• US Class Current: 606/142
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/0686 having a forming anvil staying below the tissue during stapling
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• 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 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

An apparatus for the repair of a cardiovascular valve has leaflets comprising a grasper capable of grabbing and co-apting the leaflets of the valve. In a preferred embodiment the grasper has jaws that grasp and immobilize the leaflets, and then a fastener is inserted to co-apt the leaflets. The apparatus is particularly useful for repairing mitral valves to cure mitral regurgitation.

Claims

1-28. -28. (cancelled)

29. A method for repairing a circulatory valve having leaflets in a patient suffering from regurgitation or insufficiency, said method comprising the steps of:

(a) grasping two leaflets to immobilize said leaflets, wherein the patient'"'"'s heart is not stopped; and

(b) fastening the leaflets together in a position intended to resolve the regurgitation or insufficiency.

30. A method as in claim 29, wherein the patient suffers from insufficiency and the circulatory valve is a venous valve.

31. A method for repairing a circulatory valve having leaflets in a patient suffering from regurgitation or insufficiency, said method comprising the steps of:

(a) providing a grasper capable of grasping and coapting the leaflets of the valve;

(b) grasping and immobilizing the leaflets of the valve; and

(c) inserting a fastener into the leaflets to coapt the leaflets in a position which resolves the regurgitation or insufficiency.

32. A method as in claim 31, wherein the leaflets are grasped and immobilized while the heart is not stopped.

33. A method as in claim 31, wherein the patient suffers from insufficiency and the circulatory valve is a venous valve.

34. A method of repairing a circulatory valve in a patient, the valve having leaflets, the method comprising:

accessing the valve through a blood vessel or through a controlled-bleeding entry site in a wall of the patient'"'"'s heart;

positioning distal sections of the leaflets together or substantially adjacent each other in a coapted configuration; and

securing the leaflets in the coapted configuration.

35. The method of claim 34, wherein the positioning step comprises grasping an exterior side of each leaflet.

36. The method of claim 34, wherein the distal sections of the leaflets are clamped together in the coapted configuration.

37. The method of claim 34, wherein the leaflets are fixed in opposition in the coapted configuration.

38. The method of claim 34, wherein the step of securing comprises applying a fastener to the leaflets.

39. The method of claim 38, wherein the fastener at least partially penetrates the leaflets.

40. The method of claim 39, wherein the fastener is selected from staples, coils, sutures, dual button fasteners, cufflink-like fasteners and clips.

41. The method of claim 34, wherein the step of securing comprises applying a clip to the leaflets.

42. The method of claim 41, wherein the clip does not fully penetrate the leaflets.

43. The method of claim 41, wherein the clip is U-shaped.

44. The method of claim 34, wherein the valve is in the heart.

45. The method of claim 44, wherein the valve is a mitral valve.

46. The method of claim 44, wherein accessing the valve through a controlled-bleeding entry site comprises placing an instrument through an incision in the heart wall and placing a suture around the incision to control bleeding therethrough.

47. The method of claim 44, wherein the step of accessing comprises positioning an instrument through a vein or artery into the heart.

48. The method of claim 47, wherein the step of accessing comprises introducing the instrument through an interatrial septum in the heart.

49. The method of claim 44, wherein the patient is off bypass during each step.

50. A method of repairing a circulatory valve in a patient, the valve having leaflets, the method comprising:

positioning a grasper near the valve through a blood vessel or through a controlled-bleeding entry site in a wall of the patient'"'"'s heart;

grasping the leaflets with the grasper to position distal sections of the leaflets together or substantially adjacent each other in a coapted configuration; and

securing the leaflets in the coapted configuration.

51. The method of claim 50, wherein the grasping step comprises grasping an exterior side of each leaflet.

52. The method of claim 50, wherein the distal sections of the leaflets are clamped together in the coapted configuration.

53. The method of claim 50, wherein the leaflets are fixed in opposition in the coapted configuration.

54. The method of claim 50, wherein the step of securing comprises applying a fastener to the leaflets.

55. The method of claim 54, wherein the fastener at least partially penetrates the leaflets.

56. The method of claim 55, wherein the fastener is selected from staples, coils, sutures, dual button fasteners, cufflink-like fasteners and clips.

57. The method of claim 54, wherein the fastener is applied by the grasper.

58. The method of claim 54, wherein the fastener comprises a portion of the grasper.

59. The method of claim 50, wherein the step of securing comprises applying a clip to the leaflets.

60. The method of claim 59, wherein the clip does not fully penetrate the leaflets.

61. The method of claim 59, wherein the clip is U-shaped.

62. The method of claim 50, wherein the valve is in the heart.

63. The method of claim 62, wherein the valve is a mitral valve.

64. The method of claim 62, wherein the grasper is positioned through an incision in the heart wall, the method further comprising placing a suture around the incision to control bleeding therethrough.

65. The method of claim 62, wherein the grasper is positioned through a vein or artery into the heart.

66. The method of claim 62, wherein the grasper is positioned through an interatrial septum in the heart.

67. The method of claim 62, wherein the patient is off bypass during each step.