Ablation catheter

• US 7,850,685 B2
• Filed: 06/20/2006
• Issued: 12/14/2010
• Est. Priority Date: 06/20/2005
• Status: Active Grant

• Current Assignee: Medtronic Ablation Frontiers LLC (Medtronic Plc)
• Original Assignee: Medtronic Ablation Frontiers LLC (Medtronic Plc)
• Inventors: Kunis, Christopher G., Roman, Ricardo David, Flaherty, J. Christopher, Asconeguy, Alexander J., Werneth, Randell L.
• Primary Examiner(s): Cohen; Lee S
• Application Number:
  US11/471,467
• Publication Number:
  US 20070083194A1
• Time in Patent Office: 1,638 Days
• Field of Search: 606/41
• US Class Current: 606/41
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• 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 18/1815 using microwaves
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

Devices, systems and methods are disclosed for the mapping of electrical signals and the ablation of tissue. Embodiments include an ablation catheter that has an array of ablation elements attached to a deployable carrier assembly. The carrier assembly can be transformed from a compact, linear configuration to a helical configuration, such as to map and ablate pulmonary vein ostia.

Claims

1. An ablation catheter for performing a medical procedure on a patient comprising:

an elongated, flexible, tubular body member having a proximal end, a distal end and a lumen extending therebetween;

a first control shaft coaxially disposed and slidingly received within the lumen of the tubular body member; and

a flexible carrier assembly retractable within the tubular body member including at least two discrete ablation elements configured to deliver energy to tissue;

wherein retraction of the first control shaft causes the at least two discrete ablation elements to transform from a near linear geometry to a partial helical geometry; and

a second control shaft slidingly received within the tubular body member, wherein a proximal end of the carrier assembly is attached to the second control shaft, and a distal end of the carrier assembly is attached to the first control shaft.

2. The catheter of claim 1 wherein the catheter is configured to create a continuous, curvilinear lesion in tissue of a patient.

3. The catheter of claim 2 wherein the catheter is configured to create lesions proximate the ostium of the pulmonary veins of a patient.

4. The catheter of claim 1 wherein the catheter is configured to treat a patient with an arrhythmia.

5. The catheter of claim 4 wherein the arrhythmia is atrial fibrillation.

6. The catheter of claim 1 wherein the catheter is configured to be advanced over a guidewire, wherein the distal end of the guidewire is placed in the pulmonary vein of the patient.

7. The catheter of claim 1 wherein the control shaft includes a proximal end and a distal end and a lumen extending therebetween, said lumen configured to slidingly receive a guidewire.

8. The catheter of claim 7 wherein at least one of the shaft proximal end, shaft distal end and shaft lumen includes a braided reinforcement.

9. The catheter of claim 8 wherein the braided reinforcement terminates proximally of the at least one of the shaft proximal end, shaft distal end and the shaft lumen.

10. The catheter of claim 1 wherein the first control shaft includes a distal end and an atraumatic cap at least partially surrounding said distal end.

11. The catheter of claim 10 wherein the carrier assembly includes a distal end and the atraumatic cap further surrounds at least a portion of said distal end of the carrier assembly.

12. The catheter of claim 11 wherein the atraumatic cap prevents motion between the distal end of the first control shaft and the distal end of the carrier assembly.

13. The catheter of claim 1 wherein the carrier assembly is resiliently biased in the near linear geometry.

14. The catheter of claim 1 wherein the carrier assembly is resiliently biased in the partial helical geometry.

15. The catheter of claim 1 wherein the carrier assembly comprises a single carrier arm including a proximal end and a distal end.

16. The catheter of claim 15 wherein the carrier arm proximal end is attached to the second control shaft, and the carrier arm distal end is attached to the first control shaft.

17. The catheter of claim 15 wherein the carrier arm includes a cross-sectional geometry selected from the group consisting of:

circular;

oval;

triangular;

rectangular;

trapezoidal; and

combinations thereof.

18. The catheter of claim 15 wherein the carrier arm is attached to the tubular body member at a location 90°

offset from the attachment to the control shaft.

19. The catheter of claim 15 wherein the carrier arm exits the distal end of the tubular body member.

20. The catheter of claim 15 wherein the tubular body member includes a side hole proximal to its distal end, and the carrier arm exits said side-hole.

21. The catheter of claim 1 wherein the carrier assembly is made at least partially from Nitinol.

22. The catheter of claim 21 wherein the Nitinol is resiliently biased via a heat treatment.

23. The catheter of claim 1 wherein the carrier arm further comprises an interior volume and an outer surface, and wherein the carrier arm further includes at least one side hole configured to allow a wore to pass from a location inside the carrier arm to an electrode on the outer surface of the carrier arm.

24. The catheter of claim 1 further comprising at least one temperature sensor.

25. The catheter of claim 24 wherein the at least one temperature sensor is integral to an ablation element.

26. The catheter of claim 25, wherein the temperature sensor is located on the tissue to ablation element interface.

27. The catheter of claim 24 wherein the at least one temperature sensor is located at a point on the catheter more distal than the most distal ablation element.

28. The catheter of claim 1 wherein the carrier assembly is configured such that the ablation elements make contact with pulmonary vein ostium/antrum tissue of the patient when said ablation elements are in the partial helical geometry.

29. The catheter of claim 1 wherein the carrier assembly is configured such that refraction of the control shaft a first distance causes the ablation elements to make contact with pulmonary vein ostium tissue of the patient and retraction of the control shaft a second distance also causes the ablation elements to make contact with pulmonary vein ostium tissue of the patient.

30. The catheter of claim 1 wherein at least one ablation element is an electrode configured to deliver at least electrical energy.

31. The catheter of claim 30, wherein the ablation element is radiopaque.

32. The catheter of claim 30, wherein the ablation element has a low thermal time constant.

33. The catheter of claim 1 wherein at least one ablation element is configured to deliver energy selected from the group consisting of:

sound energy such as acoustic energy and ultrasound energy;

electromagnetic energy such as electrical, magnetic, microwave and radiofrequency energies;

thermal energy such as heat and cryogenic energies;

chemical energy such as energy generated by delivery of a drug;

light energy such as infrared and visible light energies;

mechanical and physical energy;

radiation; and

combinations thereof.

34. The catheter of claim 1 wherein the at least two ablation elements are configured to deliver radiofrequency energy.

35. The catheter of claim 34 wherein at least one ablation element is configured to deliver monopolar energy to a ground pad.

36. The catheter of claim 34 wherein the at least two ablation elements are configured to transmit bipolar energy between said at least two ablation elements.

37. The catheter of claim 1 comprising at least four ablation elements.

38. The catheter of claim 37 comprising at least six ablation elements.

39. The catheter of claim 37 comprising at least eight ablation elements.

40. The catheter of claim 37 comprising at least ten ablation elements.

41. The catheter of claim 37 wherein said at least four ablation elements are substantially equally distributed along a line when the catheter is in a near linear configuration.

42. The catheter of claim 1 wherein the at least two discrete ablation elements are spaced apart at a distance between 1 and 4 mm.

43. The catheter of claim 1 wherein the at least two discrete ablation elements are spaced apart at a distance of about 1 mm.

44. The catheter of claim 1 wherein the at least two discrete ablation elements each have a length of about 3 mm.

45. The catheter of claim 1 wherein the at least two discrete ablation elements are further configured to map electrical signals present in tissue of a patient.

46. The catheter of claim 1 wherein the at least two discrete ablation elements are further configured to pace the heart of a patient.

47. The catheter of claim 1 wherein the at least two discrete ablation elements each include a heat-sinking fin.

48. The catheter of claim 1 wherein the carrier assembly has a helical diameter between 15 and 32 mm when said ablation elements are in the partial helical geometry.

49. The catheter of claim 1 further comprising a guidewire.

50. The catheter of claim 49 wherein the tubular body member is configured to slidingly receive the guidewire.

51. The catheter of claim 49 wherein the first control shaft is configured to slidingly receive the guidewire.

52. The catheter of claim 51 wherein the control shaft is configured to be advanceable toward a pulmonary vein ostium of a patient'"'"'s heart after a distal end of the guidewire is placed into the pulmonary vein.

53. The catheter of claim 50 wherein the tubular body member includes a second lumen extending between its proximal and distal ends, and said second lumen slidingly receives the guidewire.

54. The catheter of claim 50 wherein the guidewire is fixedly attached to one of the tubular body member, control shaft, and carrier assembly.

55. The catheter of claim 1 further comprising a handle on the proximal end of the tubular body member.

56. The catheter of claim 55 wherein the handle includes a control configured to operably retract the first control shaft.

57. The catheter of claim 56 wherein the control is a rotating knob.

58. The catheter of claim 57 wherein the handle includes a control configured to manipulate delivery of energy to the tissue of a patient.

59. The catheter of claim 55 further comprising a pull wire and wherein the handle includes a control operably attached to said pull wire such that operation of the control deflects the distal end of the tubular body member in a first plane.

60. The catheter of claim 59 further comprising a second pull wire and wherein the handle includes a second control operably attached to said second pull wire such that operation of the second control deflects the distal end of the tubular body member in a second plane.

61. The catheter of claim 55 wherein the handle includes a control configured to rotate the first control shaft.

62. The catheter of claim 1 further comprising an anchoring element carried by the catheter configured to be anchored in a pulmonary vein of the patient.

63. The catheter of claim 62 wherein the anchoring element comprises a balloon.

64. The catheter of claim 62 wherein the anchoring element comprises an expandable cage.

65. The catheter of claim 62 wherein the control shaft includes a distal end and the anchoring element is configured to center said distal end in the pulmonary vein ostium.

66. The catheter of claim 1 wherein advancing the second control shaft causes the at least two discrete ablation elements to transform from a near linear geometry to a partial helical geometry.

67. An ablation catheter comprising:

an elongated, flexible, tubular body member having a proximal end, a distal end and a lumen extending therebetween;

a first control shaft coaxially disposed and slidingly received within the lumen of the tubular body member; and

a flexible carrier assembly retractable within the tubular body member including at least two discrete ablation elements configured to deliver energy to tissue, wherein the carrier assembly comprises a single carrier arm including a proximal end and a distal end, wherein retraction of the first control shaft causes the at least two discrete ablation elements to transform from a near linear geometry to a partial helical geometry, and wherein the carrier arm is configured such that the same can be fully retracted within the tubular body member; and

a second control shaft slidingly received within the tubular body member, wherein the proximal end of the carrier arm is attached to the second control shaft and the distal end of the carrier arm is attached to the first control shaft.