Epicardial ablation catheter and method of use

• US 10,166,066 B2
• Filed: 03/13/2008
• Issued: 01/01/2019
• 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: Mahapatra, Srijoy, Gillies, George T.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): Vahdat, Khadijeh
• Application Number:
  US12/530,938
• Publication Number:
  US 20100114093A1
• Time in Patent Office: 3,946 Days
• Field of Search: 606 44, 606 23- 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 ablation catheter system comprising:

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

a plurality of electrodes in communication with said ablation catheter;

a catheter steering mechanism configured to orient said ablation catheter about the heart;

a catheter control device, wherein said catheter control device is configured to manipulate said catheter steering mechanism;

one or more distal irrigation apertures at said distal end of said ablation catheter, said one or more distal irrigation apertures are in communication with one or more irrigation lumens extending longitudinally toward said proximal end of said ablation catheter;

one or more distal suction apertures at said distal end of the ablation catheter, said one or more distal suction apertures are in communication with one or more suction lumens extending longitudinally toward said proximal end of said ablation catheter;

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

a sheath steering mechanism configured to orient said sheath about the heart; and

a sheath control device, wherein said sheath control device is configured to manipulate said sheath steering mechanism;

wherein, said plurality of electrodes comprise at least one of;

an anode and a cathode,

a plurality of electrodes arranged in a circumferential array around said distal end of said ablation catheter, and

a plurality of electrodes longitudinally separated on said distal end of said ablation catheter, and

wherein, at least one of said one or more distal irrigation apertures or said one or more distal suction apertures comprises a plurality of apertures arranged in a circumferential array around the distal end of the ablation catheter.

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

3. The ablation catheter system of claim 1, further comprising:

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

4. The ablation catheter system of claim 3, further comprising:

a guidewire.

5. The ablation catheter system of claim 4, wherein said guidewire is adapted to be introduced into said access needle.

6. The ablation catheter system of claim 4, wherein said sheath is positioned over said guidewire.

7. The ablation catheter system of claim 1, wherein said sheath comprises a dilator at its distal end.

8. The ablation catheter system of claim 1, further comprising a sealant device, said sealant device adapted to remain in a closed position in absence of said ablation catheter.

9. The ablation catheter system of claim 8, wherein said sealant device prevents leakage of fluids through an annular space between said ablation catheter and said sheath while it remains in the closed position.

10. The ablation catheter system of claim 8, 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.

11. The ablation catheter system of claim 8, wherein said sealant device creates a seal between an outer wall of the ablation catheter and an inner wall of the sheath.

12. The ablation catheter system of claim 11, wherein said sealant device creates a seal at or in vicinity of a most proximal portion of the sheath.

13. The ablation catheter system of claim 8, wherein the sealant device is configured to be in the closed position while the ablation catheter is within the sheath.

14. The ablation catheter system of claim 1, wherein the sheath is configured to receive the ablation catheter within a multi-flow channel of the sheath.

15. The ablation catheter system of claim 1, wherein said ablation catheter is comprised of a distal segment, a medial segment, and a proximal segment, an orientation of at least two of said distal segment, said medial segment, and said proximal segment being separately controllable by said catheter control device.

16. The ablation catheter system of claim 15, 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.

17. The ablation catheter system of claim 15, 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.

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

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

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

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

22. The ablation catheter system of claim 1, wherein said catheter control device comprises a control handle.

23. The ablation catheter system of claim 1, wherein said catheter steering mechanism comprises of one or more of the following:

wire, rod, chain, band, chord, rope, string, tubes, filaments, threads, fibers, strands.

24. The ablation catheter system of claim 1, wherein said longitudinal wall of said ablation catheter comprises pre-formed curved geometries.

25. The ablation catheter system of claim 24, wherein said longitudinal wall is not straight in absence of any force applied by said catheter steering mechanism and is configured to be straightened at a preconfigured center of curvature by actuating said catheter steering mechanism.

26. The ablation catheter system of claim 1, wherein said longitudinal wall of said ablation catheter is straight in the absence of any force applied by said catheter steering mechanism and is configured to be curved at a preconfigured center of curvature by actuating said catheter steering mechanism.

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

28. The ablation catheter system of claim 27, wherein said catheter steering mechanism further comprises:

a distal steering mechanism configured to orient said ablation catheter about said preconfigured distal center of curvature and a proximal steering mechanism configured to orient the ablation catheter about said preconfigured proximal center of curvature.

29. The ablation catheter system of claim 28, wherein said distal steering mechanism is attached at said preconfigured distal center of curvature.

30. The ablation catheter system of claim 28, wherein said proximal steering mechanism is attached at said preconfigured proximal center of curvature.

31. The ablation catheter system of claim 28, wherein said distal steering mechanism is attached to said catheter control device.

32. The ablation catheter system of claim 28, wherein said proximal steering mechanism is attached to said catheter control device.

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

34. The ablation catheter system of claim 1, wherein said ablation catheter is configured to be disposed in a thorax of the subject.

35. The ablation catheter system of claim 1, wherein said ablation catheter is configured to be disposed in a thorax of the subject by interventional procedure.

36. The ablation catheter system of claim 1, wherein said ablation catheter is configured to be disposed in a thorax of the subject by a surgical procedure.

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

38. The ablation catheter system of claim 37, 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.

39. The ablation catheter system of claim 37, wherein said temperature sensor is configured to provide information on temperatures of tissues on and around an exterior region of the heart.

40. The ablation catheter system of claim 37, wherein said temperature sensor is disposed on said distal end of said ablation catheter.

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

42. The ablation catheter system of claim 41, 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.

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

44. The ablation catheter system of claim 43 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.

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

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

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

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

49. The ablation catheter system of claim 1, wherein the one or more distal irrigation apertures comprises a plurality of distal irrigation apertures, wherein said plurality of distal irrigation apertures are arranged in a circumferential array around the distal end of the ablation catheter.

50. The ablation catheter system of claim 1, wherein the one or more distal suction apertures comprises a plurality of distal suction apertures, wherein said plurality of distal suction apertures are arranged in a circumferential array around the distal end of the ablation catheter.

51. The ablation catheter system of claim 1, wherein said plurality of electrodes comprise one or more anodes and one or more cathodes.

52. The ablation catheter system of claim 1, wherein said plurality of electrodes are arranged in a circumferential array around said distal end.

53. The ablation catheter system of claim 1, wherein said plurality of electrodes are longitudinally separated on said distal end of said ablation catheter.

54. The ablation catheter system of claim 1, wherein at least two of said plurality of electrodes are configured to be activated and deactivated independently from one another by an operator of the ablation catheter system.

55. The ablation catheter system of claim 1, wherein an energy level provided to at least two of said plurality of electrodes is configured to be varied independently from one another by an operator of the ablation catheter system.