Methods of epicardial ablation

• US 6,237,605 B1
• Filed: 09/21/1998
• Issued: 05/29/2001
• Est. Priority Date: 10/22/1996
• Status: Expired due to Term

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: Epicor Inc. (Evoqua Water Technologies Corp.)
• Inventors: Shah, Ajit S., Merrick, Daniel D., deClerq, Casper, Vaska, Matthias
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/157,824
• Time in Patent Office: 981 Days
• Field of Search: 128/898, 606/41, 607/101, 607/116, 607/122, 600/374
• US Class Current: 128/898
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• 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 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/149 bow shaped or with rotatable body at cantilever end, e.g. for resectoscopes, or coagulating rollers
• 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 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and body
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00363 Epicardium
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/145 wherein the effectors remain parallel during closing and opening
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 34/20 : Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/287 : Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61N 1/06 : for high-frequency therapy

Abstract

The invention provides apparatus and methods for mapping conduction pathways and creating transmural lesions in the heart wall for the treatment of atrial fibrillation. The apparatus may include at least one epicardial ablation probe having a plurality of electrodes for creating a transmural lesion. The apparatus and method facilitate the formation of a transmural lesion which electrically isolates the pulmonary veins from the surrounding myocardium without cutting or penetrating the pericardial reflections.

Claims

1. A method of forming a lesion in a wall of the heart, the heart being surrounded by a pericardium, the method comprising:

providing a first ablation device and a second ablation device each having at least one ablating element, the first ablation device passing through the second ablation device and being slidably received by the second ablation device;

placing the first and second ablation devices through a thoracic incision and through a pericardial penetration so that the first and second ablation devices are disposed in contact with an epicardial surface of the heart wall; and

ablating the heart wall to create at least one lesion with the ablating elements of the first and second ablation devices positioned at the epicardial surface of the heart wall.

2. The method of claim 1 wherein the at least one lesion formed by the first and second ablation devices extends continuously to form an elongate lesion.

3. The method of claim 1 wherein the at least one lesion extends continuously around four of the pulmonary veins.

4. The method of claim 1 wherein the at least one lesion electrically isolates the pulmonary veins from a portion of the heart wall.

5. The method of claim 1 wherein the first ablation device has a catch device, and the step of positioning comprises engaging the locating device with at least one of a pulmonary vein, vena cava, aorta, pulmonary artery, atrial appendage, or pericardial reflection.

6. The method of claim 1 wherein at least one of the first and second ablation devices has at least one electrode mounted thereto and the step of ablating comprises applying energy to the heart wall through said electrode.

7. The method of claim 1 wherein the at least one of the first and second ablation devices has a plurality of ablating elements and the step of ablating comprises applying energy to the heart wall through said plurality of ablating elements to create a substantially continuous lesion therebetween.

8. The method of claim 1 wherein the thoracic incision is in a subxiphoid position.

9. The method of claim 1 further comprising viewing the heart using a technique selected from fluoroscopy, echocardiography, endoscopy, transillumination and magnetic resonance imaging during at least one of the steps of placing, positioning and ablating.

10. The method of claim 1 further comprising urging at least one of the first and second ablation devices against the epicardial surface.

11. The method of claim 1 wherein the step of positioning comprises shaping a distal end of the ablation device in a preselected shape.

12. The method of claim 11 wherein the step of shaping comprises moving a steering mechanism coupled to the distal end.

13. The method of claim 12 wherein the step of moving comprises tensioning a wire coupled to the distal end.

14. A method of forming a transmural lesion in a wall of the heart adjacent to or on the pulmonary veins, the heart being surrounded by a pericardium, the method comprising:

placing at least one ablation device through a thoracic incision and through a pericardial penetration so that the at least one ablation device is disposed in contact with an epicardial surface of the heart wall;

positioning the at least one ablation device adjacent to the pulmonary veins on a posterior aspect of the heart while leaving the pericardial reflections intact;

ablating the heart wall to create a lesion around the pulmonary veins with at least one ablation device positioned at the epicardial surface of the heart wall; and

urging the ablation device against the epicardial surface, wherein the step of urging comprises applying suction through at least one suction port in the ablation device.

15. A method of forming a transmural lesion in a wall of the heart adjacent to or on the pulmonary veins, the heart being surrounded by a pericardium, the method comprising:

placing at least one ablation device through a thoracic incision and through a pericardial penetration so that the at least one ablation device is disposed in contact with an epicardial surface of the heart wall;

positioning the at least one ablation device adjacent to the pulmonary veins on a posterior aspect of the heart while leaving the pericardial reflections intact; and

ablating the heart wall to create a lesion around the pulmonary veins with at least one ablation device positioned at the epicardial surface of the heart wall; and

expanding an expandable member on the ablation device between the pericardium and the epicardium, the expandable member being configured to engage the pericardium to urge the ablation device toward the epicardium.

16. A method of forming a transmural lesion in a wall of the heart adjacent to or on the pulmonary veins, the heart being surrounded by a pericardium, the method comprising:

placing at least one ablation device through a thoracic incision and through a pericardial penetration so that the at least one ablation device is disposed in contact with an epicardial surface of the heart wall;

positioning the at least one ablation device adjacent to the pulmonary veins on a posterior aspect of the heart while leaving the pericardial reflections intact;

ablating the heart wall to create a lesion around the pulmonary veins with at least one ablation device positioned at the epicardial surface of the heart wall; and

retracting extracardiac tissue away from the ablation device during the step of ablating.

17. The method of claim 16 wherein the step of retracting comprises expanding and expandable member on the ablation device, the expandable member engaging and retracting the extracardiac tissue away from the ablation device.

18. A method of forming a transmural lesion in a wall of the heart adjacent to or on the pulmonary veins, the heart being surrounded by a pericardium, the method comprising:

placing at least one ablation device through a thoracic incision and through a pericardial penetration so that the at least one ablation device is disposed in contact with an epicardial surface of the heart wall, wherein the at least one ablation device comprises first and second free ends;

positioning the at least one ablation device adjacent to the pulmonary veins on a posterior aspect of the heart while leaving the pericardial reflections intact;

ablating the heart wall to create a lesion around the pulmonary veins with at least one ablation device positioned at the epicardial surface of the heart wall; and

positioning the first and second free ends on opposite sides of a tissue layer and approximating the first and second free ends in opposing alignment separated by the tissue layer.

19. The method of claim 18 wherein the step of approximating comprises magnetically attracting the first free end to the second free end.

20. A method of forming a lesion in a wall of the heart, the heart being surrounded by a pericardium, the method comprising:

providing a first ablating device having an ablating element and at least one suction port, the at least one suction port being coupled to a source of vacuum;

placing the first ablation device through a thoracic incision and through a pericardial penetration so that the first ablation device is disposed in contact with an epicardial surface of the heart wall;

ablating the heart wall with the first ablating device to create an elongate continuous lesion in the heart wall with the first ablation device positioned at the epicardial surface of the heart wall; and

applying suction through the at least one suction port in the ablation device to urge the ablating device into contact with the epicardial surface of the heart wall.

21. The method of claim 20, wherein:

the placing step is carried out with the first ablating device having a plurality of ablating elements which are spaced apart from one another.

22. The method of claim 21, wherein:

the ablating step is carried out to create an elongate continuous lesion.

23. The method of claim 22, wherein:

the ablating step is carried out to create a closed loop.

24. The method of claim 23, wherein:

the ablating step is carried out to create an elongate continuous lesion around the pulmonary veins.

25. The method of claim 20, wherein:

the ablating step is carried out with the first ablating device having a curved shape to conform to the epicardial surface heart.

26. The method of claim 20, wherein:

the positioning step is carried out with the device having means for locating the device at an anatomical structure.

27. The method of claim 26, wherein:

the positioning step is carried out with the locating means positioned at an exterior surface of one of a pulmonary vein, vena cava, aorta, pulmonary artery, atrial appendage, and pericardial reflection.

28. A method of forming a lesion in a wall of the heart, the heart being surrounded by a pericardium, the method comprising:

providing a first ablation device having an expandable member;

placing the first ablation device through a thoracic incision and through a pericardial penetration so that the first ablation device is disposed in contact with a location on an epicardial surface of the heart wall;

ablating the heart wall to create a lesion with the first ablation device positioned at the epicardial surface of the heart wall; and

expanding the expandable member on the first ablation device to hold the first ablation device at the location on the epicardial surface of the heart wall.

29. The method of claim 28, wherein:

the expanding step is carried out to retract extracardiac tissue away from the first ablation device during the step of ablating.

30. The method of claim 28, further comprising the step of:

applying suction through the at least one suction port in the first ablation device to urge the first ablation device into contact with the epicardial surface of the heart wall.

31. The method of claim 28, wherein:

the placing step is carried out with the first ablating device having a plurality of ablating elements which are spaced apart from one another.

32. The method of claim 28, wherein:

the ablating step is carried out to create an elongate continuous lesion.

33. The method of claim 32, wherein:

the ablating step is carried out to create a closed loop.

34. The method of claim 33, wherein:

the ablating step is carried out to create an elongate continuous lesion around the pulmonary veins.

35. The method of claim 28, wherein:

the ablating step is carried out with the first ablating device having a curved shape to conform to the epicardial surface heart.

36. The method of claim 28, wherein:

the positioning step is carried out with the device having means for locating the device at an anatomical structure.

37. The method of claim 36, wherein:

the positioning step is carried out with the locating means positioned at an exterior surface of one of a pulmonary vein, vena cava, aorta, pulmonary artery, atrial appendage, and pericardial reflection.

38. A method of forming a lesion in a wall of the heart, the heart being surrounded by a pericardium, the method comprising:

placing at least one ablation device through a thoracic incision and through a pericardial penetration so that the at least one ablation device is disposed in contact with an epicardial surface of the heart wall, wherein the at least one ablation device has a first end and a second free end;

positioning the at least one ablation device at an epicardial location while leaving a pericardial reflection intact;

ablating the heart wall to create a lesion at the epicardial location of the heart wall; and

positioning the first and second free ends on opposite sides of the pericardial reflection and approximating the first and second free ends in opposing alignment separated by the pericardial reflection.

39. The method of claim 38, wherein:

the ablating step is carried out with the at least one ablation device ablating tissue beneath the pericardial reflection while leaving the pericardial reflection intact.

40. The method of claim 38, wherein:

the providing step is carried out with the at least one ablating device comprising a first ablating device and a second ablating device, the first ablating device having the first end and the second ablating element having the second end.

41. The method of claim 38, wherein:

the positioning step is carried out by magnetically attracting the first free end to the second free end.

42. The method of claim 38, further comprising the step of:

applying suction through at least one suction port to urge the at least one ablating device into contact with an epicardial surface.

43. The method of claim 38, wherein:

the placing step is carried out with the at least one ablating device having a plurality of ablating elements which are spaced apart from one another.

44. The method of claim 43, wherein:

the ablating step is carried out to create an elongate continuous lesion.

45. The method of claim 44, wherein:

the ablating step is carried out to create a closed loop.

46. The method of claim 45, wherein:

the ablating step is carried out to create an elongate continuous lesion around the pulmonary veins.

47. The method of claim 38, wherein:

the ablating step is carried out with the at least one ablating device having a curved shape to conform to an epicardial surface.

48. The method of claim 38, wherein:

the positioning step is carried out with the at least one ablating device having means for locating the at least one ablating device at an anatomical structure.

49. The method of claim 48, wherein:

the positioning step is carried out with the locating means positioned at an exterior surface of one of a pulmonary vein, vena cava, aorta, pulmonary artery, atrial appendage, and pericardial reflection.