METHOD AND SYSTEM FOR POSITIONING AN ENERGY SOURCE

• US 20100049099A1
• Filed: 07/17/2009
• Published: 02/25/2010
• Est. Priority Date: 07/18/2008
• Status: Abandoned Application

• Current Assignee: Auris Health, Inc. (Johnson & Johnson)
• Original Assignee: VytronUS, Inc. (Johnson & Johnson)
• Inventors: THAPLIYAL, Hira V., ARENSON, James W., GALLUP, David A.
• Application Number:
  US12/505,326
• Publication Number:
  US 20100049099A1
• Time in Patent Office: Days
• US Class Current: 601/2
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 34/70 Manipulators specially adapted for use in surgery
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

An ablation system for treating atrial fibrillation in a patient comprises an inner shaft having proximal and distal ends as well as a lumen therebetween. A distal tip assembly is adjacent the inner shaft distal end, and the distal tip assembly comprises an energy source and a sensor. The energy source is adapted to deliver energy to a target tissue so as to create a zone of ablation in the target tissue. This blocks abnormal electrical activity and thus reduces or eliminates atrial fibrillation in the patient. The system also has an outer shaft with proximal and distal ends, and a lumen therebetween. The inner shaft is slidably disposed in the outer shaft lumen, and the inner shaft is rotatable, bendable and linearly slidable relative to the outer shaft. The outer shaft is rotatable, bendable and linearly slidable relative to the target tissue.

Claims

1. An ablation system for treating atrial fibrillation in a patient, said system comprising:

an elongate inner shaft having a proximal end, a distal end and a lumen therebetween;

a distal tip assembly adjacent the distal end of the inner shaft, the distal tip assembly comprising an energy source and a sensor, wherein the energy source is adapted to deliver energy to a target tissue so as to create a zone of ablation in the target tissue that blocks abnormal electrical activity thereby reducing or eliminating the atrial fibrillation in the patient; and

an elongate outer shaft having a proximal end, a distal end and a lumen therebetween,

wherein the inner shaft is slidably disposed in the outer shaft lumen, and wherein the inner shaft is rotatable, bendable and linearly slidable relative to the outer shaft, and wherein the outer shaft is rotatable, bendable and linearly slidable relative to the target tissue.

2. The system of claim 1, wherein the distal tip assembly comprises an outer housing, the energy source and sensor being disposed therein.

3. The system of claim 2, wherein the outer housing comprises an open end.

4. The system of claim 2, wherein the housing comprises a plurality of slots on one end forming a castellated region.

5. The system of claim 2, wherein the energy source is recessed from a distal end of the housing such that the energy source does not contact the target tissue when the energy source delivers energy.

6. The system of claim 1, wherein the energy source comprises an ultrasound transducer.

7. The system of claim 1, wherein the energy source delivers one of radiofrequency energy, microwaves, photonic energy, thermal energy, and cryogenic energy.

8. The system of claim 1, wherein the energy source delivers the energy at an angle ranging from 65 to 115 degrees relative to a surface of the target tissue.

9. The system of claim 1, wherein the zone of ablation follows an arcuate path.

10. The system of claim 1, wherein the zone of ablation follows a linear path.

11. The system of claim 1, wherein the sensor is adapted to detect gap distance between a surface of the target tissue and the energy source.

12. The system of claim 1, wherein the sensor is adapted to detect an angle between the energy source and a surface of the target tissue.

13. The system of claim 1, wherein the sensor is adapted to determine thickness of the target tissue.

14. The system of claim 1, wherein the sensor is adapted to determine characteristics of the target tissue.

15. The system of claim 1, wherein the sensor comprises an ultrasound transducer.

16. The system of claim 15, wherein the energy source comprises the same ultrasound transducer.

17. The system of claim 1, wherein the sensor comprises one of an infrared sensor and a radiofrequency sensor.

18. The system of claim 1, wherein the sensor comprises a positioning mechanism adjacent the distal end of the outer shaft, wherein the positioning mechanism is adapted to facilitate location of an anatomic structure and also adapted to anchor the ablation system to the anatomic structure.

19. The system of claim 18, wherein the inner shaft is rotatable around the positioning mechanism.

20. The system of claim 18, wherein the positioning mechanism is positionable in the outer shaft lumen, and wherein the positioning mechanism is in a substantially linear configuration while disposed therein.

21. The system of claim 18, wherein the positioning mechanism comprises a coil.

22. The system of claim 18, wherein the positioning mechanism comprises a plurality of wires biased to flare radially outward when unconstrained.

23. The system of claim 18, wherein the positioning mechanism is adapted to exert an outward biasing force against the anatomic structure, thereby anchoring the ablation system thereto.

24. The system of claim 18, wherein the anatomic structure comprises a pulmonary vein, and wherein the positioning mechanism is positionable in the pulmonary vein and adapted to indicate an angle of entry of the inner shaft into the pulmonary vein.

25. The system of claim 1, further comprising a guide catheter, the outer shaft being slidably positioned in the guide catheter.

26. The system of claim 1, wherein the target tissue comprises heart tissue.

27. The system of claim 1, wherein the target tissue comprises a pulmonary vein or tissue adjacent thereto.

28. The system of claim 1, wherein the inner shaft or the outer shaft comprises a braided portion.

29. The system of claim 1, wherein the inner shaft or the outer shaft comprises a spring coil.

30. The system of claim 25, further comprising an anchoring mechanism coupled with the ablation system and configured to stabilize the distal tip assembly.

31. The system of claim 30, wherein the anchor mechanism comprises an expandable member.

32. The system of claim 31, wherein the expandable member comprises a balloon.

33. The system of claim 30, wherein the anchor member comprises a shapeable wire coupleable with the target tissue.

34. The system of claim 30, wherein the anchor member comprises one or more tissue engaging barbs or hooks.

35. The system of claim 1, further comprising a bending mechanism operably coupled with the inner shaft.

36. The system of claim 35, wherein the bending mechanism comprises a pull wire operably coupled adjacent the distal end of the inner shaft and wherein a portion of the pull wire is disposed along an outer surface of the inner shaft such that when the pull wire is actuated, the inner shaft deflects radially inward or outward relative to the portion of the pull wire outside of the inner shaft, and wherein the portion of the pull wire remains in a substantially linear configuration.

37. The system of claim 35, wherein the bending mechanism comprises a first and a second pull wire, the first pull wire coupled with a distal region of the inner shaft and the second pull wire coupled with a proximal region of the inner shaft, the pull wires adapted to bend the inner shaft in two locations, a first bend and a second bend.

38. The system of claim 37, further comprising an actuator disposed near a proximal end of the inner shaft and adapted to actuate the pull wires thereby bending the inner shaft and forming the first bend and the second bend along the inner shaft.

39. The system of claim 38, wherein the first bend and the second bend are in different planes.

40. The system of claim 1, further comprising a bending mechanism operably coupled with the outer shaft.

41. The system of claim 40, wherein the bending mechanism comprises a first and a second pull wire, the first pull wire coupled with a distal region of the outer shaft and the second pull wire coupled with a proximal region of the outer shaft, the pull wires adapted to bend the outer shaft in two locations, a first bend and a second bend.

42. The system of claim 41, further comprising an actuator disposed near a proximal end of the outer shaft and adapted to actuate the pull wires thereby bending the inner shaft and forming the first bend and the second bend along the inner shaft.

43. The system of claim 42, wherein the first bend and the second bend are in different planes.

44. A method for treating atrial fibrillation in a patient by ablating tissue, said method comprising:

providing an ablation system comprising an outer shaft and an inner shaft having a distal tip assembly, the distal tip assembly comprising an energy source and a sensor, wherein the outer shaft is slidably disposed over at least a portion of the inner shaft;

positioning the distal tip assembly adjacent the tissue;

manipulating the inner shaft or the outer shaft so as to place the energy source in a desired position relative to the tissue;

delivering energy from the energy source to the tissue; and

creating a partial or complete zone of ablation in the tissue thereby blocking abnormal electrical activity and reducing or eliminating the atrial fibrillation.

45. The method of claim 44, wherein the ablation system further comprises a guide sheath, the method further comprising positioning a distal portion of the guide sheath across an atrial septum of the patient'"'"'s heart.

46. The method of claim 44, wherein the step of positioning comprises advancing the distal tip assembly intravascularly into the patient'"'"'s heart.

47. The method of claim 44, wherein the step of manipulating comprises slidably moving the inner shaft relative to the outer shaft.

48. The method of claim 44, wherein the step of manipulating comprises rotating the inner shaft relative to the outer shaft.

49. The method of claim 44, wherein the step of manipulating comprises bending the inner shaft.

50. The method of claim 49, wherein the bending comprises bending the inner shaft in two or more locations.

51. The method of claim 50, wherein the two or more bends lie in the same plane.

52. The method of claim 49, wherein the bending comprises actuating one or more pull wires coupled to the inner shaft.

53. The method of claim 44, wherein the step of manipulating comprises slidably moving the outer shaft.

54. The method of claim 44, wherein the step of manipulating comprises rotating the outer shaft.

55. The method of claim 44, wherein the step of manipulating comprises bending the outer shaft.

56. The method of claim 55, wherein the bending comprises bending the outer shaft in two or more locations.

57. The method of claim 56, wherein the two or more bends lie in the same plane.

58. The method of claim 55, wherein the bending comprises actuating one or more pull wires coupled to the outer shaft.

59. The method of claim 44, wherein the step of manipulating comprises rotating either the inner or the outer shaft in a first direction and rotating the inner or the outer shaft in a second direction opposite the first direction so as to reduce binding or torque buildup in the inner or the outer shaft.

60. The method of claim 44, wherein the step of manipulating comprises moving the energy source so as to direct the energy from the energy source to the tissue in a raster pattern.

61. The method of claim 44, wherein the step of manipulating comprises synchronizing movement of the energy source with the patient'"'"'s heart rate.

62. The method of claim 44, wherein the energy source comprises an ultrasound transducer and the step of delivering the energy comprises delivering an ultrasound beam from the transducer to the tissue.

63. The method of claim 44, wherein the step of delivering the energy comprises delivering one of radiofrequency energy, microwave energy, photonic energy, thermal energy, and cryogenic energy.

64. The method of claim 44, wherein the step of creating the zone of ablation comprises forming a circular ablation path.

65. The method of claim 64, wherein the ablation path encircles at least one pulmonary vein.

66. The method of claim 44, wherein the step of creating the zone of ablation comprises forming a linear ablation path.

67. The method of claim 44, wherein the ablation system further comprises a sensor, the method further comprising sensing characteristics of the tissue with the sensor.

68. The method of claim 67, wherein the sensor comprises an ultrasound transducer.

69. The method of claim 68, wherein the energy source comprises the same ultrasound transducer.

70. The method of claim 69, further comprising switching modes between delivering energy from the ultrasound transducer and sensing with the ultrasound transducer.

71. The method of claim 67, wherein the characteristics of the tissue comprise position of the tissue relative to the energy source.

72. The method of claim 71, wherein the position comprises a gap distance between the tissue and a surface of the energy source.

73. The method of claim 71, wherein the position comprises a relative angle between the energy source and the tissue.

74. The method of claim 71, wherein the characteristics of the tissue comprise thickness of the tissue or thickness of the ablation zone.

75. The method of claim 67, wherein the sensor comprises a positioning mechanism, the method further comprising advancing the positioning mechanism from either the inner or the outer shaft into the tissue or tissue adjacent thereto, the positioning mechanism facilitating locating an anatomical structure.

76. The method of claim 75, wherein the positioning mechanism comprises a plurality of wires, the method further comprising positioning the wires into a pulmonary vein while observing the shape of the wires.

77. The method of claim 71, further comprising guiding the energy based on the characteristics that are sensed.

78. The method of claim 72, further comprising maintaining the gap at a desired value.

79. The method of claim 44, wherein the tissue comprises left atrial tissue.

80. The method of claim 44, wherein the tissue comprises a pulmonary vein or tissue adjacent thereto.

81. The method of claim 44, further comprising cooling the energy source.

82. The method of claim 44, further comprising anchoring the distal tip assembly relative to the tissue.

83. The method of claim 82, wherein the anchoring step comprises coupling a wire with the tissue.

84. The method of claim 82, wherein the anchoring step comprises expanding an expandable member disposed on the outer shaft.

85. The method of claim 84, wherein the expandable member comprises a balloon.