Epicardial Ablation Catheter and Method of Use

• US 20100114093A1
• Filed: 03/13/2008
• Published: 05/06/2010
• Est. Priority Date: 03/13/2007
• Status: Active Grant

• Current Assignee: University of Virginia
• Original Assignee: University of Virginia Patent Foundation (University of Virginia)
• Inventors: Gillies, George T., Mahapatra, Srijoy
• Granted Patent: US 10,166,066 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• 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 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00035 with return means
• CPC Class Codes: A61B 2018/00363 Epicardium
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 2218/007 Aspiration
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

An aspect of various embodiments of the present invention system and method provide, but not limited thereto, a novel means for epicardial ablation using a double-curve steerable sheath and a double-curve deflectable open irrigated-tip/suction catheter that can be guided around the apex of the heart and adjusted so as to position the distal tip optimally. The catheter can also both deliver fluid to and withdraw fluid from the pericardial space. Access to the epicardial surface of the heart is via a subxiphoid entry. The method and means presented include, but are not limited to, steering, energy delivery, bipolar mapping, placement and use of electrodes, irrigation, suction of irrigation fluid, and other details of the subject invention.

Claims

1. An ablation catheter system for ablation of epicardial tissue of a heart of a subject, said system comprising:

an ablation catheter, said ablation catheter comprising a distal end, proximal end, and longitudinal wall there between;

one or more electrodes in communication with said ablation catheter; and

one or more distal irrigation apertures at said distal end, said distal irrigation apertures in communication with one or more irrigation lumens extending longitudinally toward said proximal end, or

one or more distal suction apertures at said distal end, said distal suction apertures in communication with one or more suction lumens extending longitudinally toward said proximal end.

2. The system of claim 1, wherein said system comprises both of said one or more irrigation apertures and said one or more suction apertures.

3. The system of claim 1, wherein said one or more irrigation apertures and said one or more suction apertures comprise the same aperture.

4. The system of claim 1, wherein said one or more irrigation lumens and said one or more suction lumens comprise the same one or more lumens.

5. The system of claim 1, wherein said one or more irrigation and said one or more suction lumens are multi-flow channels.

6. The system of claim 1, further comprising:

an access needle, said access needle adapted to be inserted into the epicardial region.

7. The system of claim 6, further comprising:

a guidewire.

8. The system of claim 7, wherein said guidewire is adapted to be introduced into said access needle.

9. The system of claim 1, further comprising:

a sheath, said sheath comprising a distal end, proximal end, and longitudinal wall there between, and wherein said sheath is adapted for receiving said ablation catheter therein.

10. The system of claim 9, further comprising:

an access needle, said access needle adapted to be inserted into the epicardial region.

11. The system of claim 10, further comprising:

a guidewire.

12. The system of claim 11, wherein said guidewire is adapted to be inserted into said access needle.

13. The system of claim 11, wherein said sheath is positioned over said guidewire.

14. The system of claim 9, wherein said sheath comprises a dilator at its distal end.

15. The system of claim 9, further comprising a sealant device, said sealant device adapted to remain in a closed position in the absence of said ablation catheter.

16. The system of claim 15, wherein said sealant device prevents the leakage of fluids through the annular space between said ablation catheter and said sheath while it remains in the closed position.

17. The system of claim 15, wherein said sealant device comprises at least one of the following:

an o-ring diaphragm, a septum-like diaphragm, a valve diaphragm, a hinged diaphragm or a wall or any combination thereof.

18. The system of claim 15, wherein said sealant device creates a seal between the outer wall of the catheter and the inner wall of the sheath.

19. The system of claim 18, wherein said sealant device creates a seal at or in the vicinity of the most proximal portion of the sheath.

20. The system of claim 15, wherein the sealant device may be in the closed position while the catheter is within the sheath.

21. The system of claim 9, wherein the sheath receives the ablation catheter within a multi-flow channel.

22. The system of claim 1, wherein said ablation catheter is comprised of a distal segment, a medial segment, and a proximal segment.

23. The system of claim 22, wherein said distal segment is no greater than 5 cm in length, said medial segment is no greater than 15 cm in length, and said proximal segment is no greater than 10 cm in length.

24. The system of claim 22, wherein said distal segment is no greater than 15 cm in length, said medial segment is no greater than 45 cm in length, and said proximal segment is no greater than 30 cm in length.

25. The system of claim 1, wherein said ablation catheter has a total length of less than 200 cm.

26. The system of claim 1, wherein said ablation catheter has a total length of less than 100 cm.

27. The system of claim 1, wherein said ablation catheter has a total length of less than 50 cm.

28. The system of claim 1, wherein said ablation catheter has a total length of less than 25 cm.

29. The system of claim 1, further comprising:

a steering means for orienting said ablation catheter about the heart.

30. The system of claim 29, further comprising a control device, wherein said control device manipulates said steering means.

31. The system of claim 30, wherein said control device comprises a control handle.

32. The system of claim 29, wherein said steering means are comprised of one or more of the following:

wire, rod, chain, band, chord, rope, string, tubes, filaments, threads, fibers, strands, or any combination thereof.

33. The system of claim 29, wherein said longitudinal wall of said ablation catheter comprises pre-formed curved geometries.

34. The system of claim 33, wherein said longitudinal walls are not straight in the absence of any force applied by said steering means and can be straightened by actuating said steering means.

35. The system of claim 29, wherein said longitudinal wall of said ablation catheter is straight in the absence of any force applied by said steering means and that can be curved by actuating said steering means.

36. The system of claim 1, wherein said ablation catheter comprises a distal center of curvature and a proximal center of curvature.

37. The system of claim 1, wherein said ablation catheter comprises a distal center of curvature or a proximal center of curvature.

38. The system of claim 37, further comprising:

a distal steering means for orienting said ablation catheter about said distal center of curvature and a proximal steering means for orienting the catheter about said proximal center of curvature.

39. The system of claim 38, wherein said distal steering means attach at or in the vicinity of said distal center of curvature

40. The system of claim 38, wherein said proximal steering means attach at or in the vicinity of said proximal center of curvature.

41. The system of claim 38, wherein said distal steering means attach to the control device.

42. The system of claim 38, wherein said proximal steering means attach to the control device.

43. The system of claim 1, wherein said ablation catheter is disposed in the thorax of the subject for said epicardial ablation.

44. The system of claim 43, wherein said disposal is accomplished by interventional procedure.

45. The system of claim 43, wherein said disposal is accomplished by a surgical procedure.

46. The system of claim 1, further comprising a temperature sensor in communication with said system.

47. The system of claim 46, wherein said temperature sensor is comprised of one or more of the following:

thermocouples, thermistors, fiber optic sensors, resistive temperature devices, semiconductor temperature sensors, and temperature transducers or any combination thereof.

48. The system of claim 46, wherein said temperature sensor provides information on temperatures of tissues on and around the exterior region of the heart.

49. The system of claim 46, wherein said temperature sensor is disposed on said distal end of said ablation catheter.

50. The system of claim 1, further comprising one or more proximal suction apertures in communication with said one or more suction lumens.

51. The system of claim 50, wherein said one or more proximal suction apertures comprises one or more of the following:

branch channel, side channel, connector, port hole, outlet, window, point of egress or any combination thereof.

52. The system of claim 1, further comprising one or more proximal irrigation apertures in communication with said one or more irrigation lumens.

53. The system of claim 52 wherein said one or more proximal irrigation apertures comprises one or more of the following:

branch channel, side channel, connector, port hole, outlet, window, point of ingress or any combination thereof.

54. The system of claim 1, wherein one or more of said distal irrigation apertures each comprise a hole with a circular geometry.

55. The system of claim 1, wherein one or more of said distal suction apertures each comprise a hole with a circular geometry.

56. The system of claim 1, wherein one or more of said distal irrigation apertures each comprise a hole with a non-circular geometry.

57. The system of claim 1, wherein one or more of said distal suction apertures each comprise a hole with a non-circular geometry.

58. The system of claim 1, wherein said distal irrigation apertures are arranged in a circumferential array around the distal end of the catheter.

59. The system of claim 1, wherein said distal suction apertures are arranged in a circumferential array around the distal end of the catheter.

60. The system of claim 1, wherein said one or more electrodes comprise one or more anodes and one or more cathodes.

61. The system of claim 1, wherein said one or more electrodes are arranged in a circumferential array around said distal end.

62. The system of claim 1, in which said one or more electrodes are longitudinally separated on said distal end of said ablation catheter.

63. The system of claim 1, wherein said electrodes are independently controlled.

64. The system of claim 63, wherein said independent controlling comprises varying the energy level of said one or more electrodes.

65. The system of claim 1, wherein said lumens are capable of delivering drugs or other therapeutic agents to said subject.

66. The system of claim 1 wherein said subject is a human being.

67. The system of claim 1, wherein said subject is intubated.

68. The system of claim 1, wherein said subject is not intubated.

69. A method for ablating epicardial tissue of a heart of a subject, said method comprising:

ablating the epicardial tissue of the heart using one or more electrodes on an ablation catheter; and

irrigating in a region of the epicardial tissue, or

suctioning in a region of the epicardial tissue.

70. The method of claim 69, wherein said method comprises both said irrigating and said suctioning.

71. The method of claim 69, further comprising:

inserting a sheath to a region of the epicardial tissue.

72. The method of claim 71, further comprising:

inserting said ablation catheter into said sheath.

73. The method of claim 72, further comprising:

inserting an access needle into the epicardial region.

74. The method of claim 73, further comprising:

inserting a guidewire into said access needle

75. The method of claim 74, further comprising positioning said sheath coaxially over said guidewire.

76. The method of claim 72, wherein said sheath comprises a dilator at its distal end.

77. The method of claim 71, further comprising:

sealing said sheath around said ablation catheter.

78. The method of claim 71, wherein said ablation catheter is comprised of a distal segment, a medial segment, and a proximal segment.

79. The method of claim 78, wherein said distal segment is no greater than 5 cm in length, said medial segment is no greater than 15 cm in length, and said proximal segment is no greater than 10 cm in length.

80. The method of claim 78, wherein said distal segment is no greater than 15 cm in length, said medial segment is no greater than 45 cm in length, and said proximal segment is no greater than 30 cm in length.

81. The method of claim 71, wherein said ablation catheter has a total length of less than 200 cm.

82. The method of claim 71, wherein said ablation catheter has a total length of less than 100 cm.

83. The method of claim 71, wherein said ablation catheter has a total length of less than 50 cm.

84. The method of claim 71, wherein said ablation catheter has a total length of less than 25 cm.

85. The method of claim 69, further comprising:

steering said ablation catheter about the heart.

86. The method of claim 69, wherein said ablation catheter comprises a distal center of curvature and a proximal center of curvature.

87. The method of claim 86, further comprising:

steering said ablation catheter about said distal center of curvature; and

steering said ablation catheter about said proximal center of curvature.

88. The method of claim 69 wherein said ablation catheter comprises a distal center of curvature or a proximal center of curvature.

89. The method of claim 69, further comprising:

disposing said ablation catheter in the thorax of the subject for said epicardial ablation.

90. The method of claim 89, wherein said disposal is accomplished by interventional procedure.

91. The method of claim 89, wherein said disposal is accomplished by surgical procedure.

92. The method of claim 69, further comprising:

sensing information on temperatures of tissues on and around the exterior region of the heart.

93. The method of claim 69, further comprising:

sensing information on temperatures of tissues in a region of the epicardial tissue

94. The method of claim 69, wherein said one or more electrodes are independently controlled.

95. The method of claim 94, wherein said independent controlling comprises varying the energy level of said one or more electrodes.

96. The method of claim 69, further comprising lumens capable of delivering drugs or other therapeutic agents to said subject.

97. The method of claim 69 wherein said subject is a human being.

98. The method of claim 69 wherein said subject is intubated.

99. The method of claim 69 wherein said subject is not intubated.