Device and method for forming a circumferential conduction block in a pulmonary vein

• US 6,164,283 A
• Filed: 01/29/1999
• Issued: 12/26/2000
• Est. Priority Date: 07/08/1997
• Status: Expired due to Term

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Lesh, Michael D.
• Primary Examiner(s): Nguyen, Dinh X.
• Application Number:
  US09/240,068
• Time in Patent Office: 697 Days
• Field of Search: 128/898, 128/897, 607/122, 607/119, 607/115, 607/96, 607/98, 607/99, 607/101, 606/1, 606/32, 604/22, 601/1
• US Class Current: 128/898
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/10 Power sources therefor
• 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 2017/22038 with a guide wire
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00107 Coatings on the energy applicator
• CPC Class Codes: A61B 2018/00148 with metal
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• 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 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

A method of treatment of a patient diagnosed with atrial arrhythmia by forming a circumferential conduction block in a region of tissue at a location where a pulmonary vein extends from an atrium. The method includes either forming one such circumferential conduction block around one of the pulmonary vein ostia, forming multiple such circumferential conduction blocks around each one of the pulmonary vein ostia or in subset combinations thereof. The circumferential conduction block may also surround a pulmonary vein in order to bridge the adjacent ends of two linear lesions also extending along the left posterior atrial wall and between the pulmonary vein and another adjacent pulmonary vein in a less-invasive "maze"-type procedure. The circumferential conduction block may also be formed to intersect with another similar circumferential conduction block around an adjacent pulmonary vein ostium in a modified and improved version of the "maze"-type procedure. A circumferential ablation device is provided which is adapted for forming the circumferential conduction block and includes a pear-shaped expendable member with a circumferential ablation element located along a contoured, tapered surface of the pear shape such that the circumferential ablation element is adapted to engage the circumferential path of tissue along the atrial wall when at least a portion of the expendable member is engaged within the pulmonary vein ostium. Another device is also provided for use according to the inventive method and includes a "loop"-shaped ablation member which is adapted to form the circumferential lesion by advancing the looped ablation member against the tissue to be ablated.

Claims

1. A method for treating atrial arrhythmia in a patient, comprising:

forming a circumferential conduction block in a circumferential region of tissue at a location where a pulmonary vein extends from an atrium in the patient,

wherein the circumferential conduction block formed is continuous along the circumferential region of tissue, and

wherein the circumferential conduction block is formed without contacting the tissue with an ablative fluid medium.

2. The method of claim 1, wherein the atrial arrhythmia originates at least in part from an arrhythmogenic origin located along the pulmonary vein wall, and wherein the circumferential conduction block is located at a position along the longitudinal axis which includes the arrhythmogenic origin.

3. The method of claim 1, wherein the atrial arrhythmia originates at least in part from an arrhythmogenic origin located along the pulmonary vein wall, and wherein the circumferential conduction block is located at a position which is between the arrhythmogenic origin and the left atrial wall, such that the left atrium is isolated from the electrical conduction propagating from the arrhythmogenic origin.

4. The method of claim 1, further comprising:

ablating the circumferential region of tissue with a circumferential ablation device assembly having a circumferential ablation element coupled to a circumferential ablation member located on a distal end portion of an elongate catheter body, thereby forming a circumferential lesion which comprises the circumferential conduction block.

5. The method of claim 4, wherein the circumferential region of tissue defines an ablation region where the circumferential conduction block is to be desirably formed, said method further comprising:

positioning the circumferential ablation element within the pulmonary vein lumen at or adjacent to the ablation region; and

actuating the circumferential ablation element and ablating the circumferential region of tissue to thereby form the circumferential conduction block.

6. The method of claim 5, further comprising:

forming the circumferential lesion to have a lesion width along the longitudinal axis and also a lesion circumference circumscribing the pulmonary vein, wherein the lesion width is less than two-thirds the lesion circumference.

7. The method of claim 5, wherein the ablation region is in the region of the pulmonary vein ostium.

8. The method of claim 5, wherein the distal end portion of the elongate body further comprises a sensing element that is coupled to a signal monitoring circuit, said method further comprising:

monitoring electrical conduction signals along the pulmonary vein wall adjacent to the sensing element with the signal monitoring circuit; and

identifying an origin of atrial arrhythmia in the pulmonary vein based upon the monitored electrical conduction signals.

9. The method of claim 8, further comprising:

selecting the ablation region located between the identified origin of atrial arrhythmia and the left atrium.

10. The method of claim 5, wherein the circumferential ablation member further comprises an expandable member that is adjustable between a radially collapsed position and a radially expanded position and that includes a working length coupled to and extending longitudinally of the circumferential ablation element, with an expanded outer diameter of the working length when in the radially expanded position that is larger than a collapsed outer diameter of the working length when in the radially collapsed position, the expanded outer diameter being sufficient to engage an inner circumference of the pulmonary vein wall, said method further comprising:

expanding the expandable member from the radially collapsed position to the radially expanded position such that at least a portion of the circumferential outer surface engages the pulmonary vein wall along the ablation region.

11. The method of claim 10, further comprising:

expanding the expandable member from the radially collapsed position to the radially expanded position while the expandable member is positioned within the left atrium; and

advancing the expandable member when in the radially expanded position into the pulmonary vein ostium until at least a portion of the working length coupled to the ablation element circumferentially engages the pulmonary vein wall in a region of the pulmonary vein ostium.

12. The method of claim 10, wherein the expandable member further comprises a balloon which is fluidly coupled to a pressurizeable fluid source, said method further comprising:

expanding the balloon to the radially expanded position by pressurizing the balloon with fluid from the pressurizeable fluid source.

13. The method of claim 10, further comprising forming the circumferential lesion to have a lesion width relative to the longitudinal axis which is less than two-thirds of the working length of the expandable member.

14. The method of claim 10, wherein the distal end portion of the elongate catheter body further includes a perfusion lumen extending between a distal perfusion port located distally of the expandable member and a proximal perfusion port located proximally of the expandable member, said method further comprising:

allowing antegrade blood flow to perfuse into the distal perfusion port, through the perfusion lumen, and out the proximal perfusion port when the expandable member is in the radially expanded position.

15. The method of claim 10, further comprising:

providing a kit which includes a plurality of said circumferential ablation device assemblies, the working length of each expandable member of each circumferential ablation device assembly in the kit having a different expanded outer diameter than the other expanded outer diameters of the other expandable members in the kit, when in the radially expanded position, said method further comprising;

measuring a diameter of the pulmonary vein lumen at the ablation region where the circumferential conduction block is to be desirably formed; and

selecting a circumferential ablation device from the kit of circumferential ablation devices according to the measured diameter.

16. The method of claim 15, wherein the ablation region includes the pulmonary vein ostium.

17. The method of claim 15, further comprising:

injecting contrast material into at least one of a right atrium, a right ventricle, and a pulmonary artery;

forming an X-ray image of the pulmonary vein as the contrast material flows through the pulmonary vein in the ablation region; and

measuring the diameter of the pulmonary vein at the ablation region using the X-ray image of the pulmonary vein.

18. The method of claim 15, further comprising:

inserting an ultrasound imaging probe into an esophagus in a region adjacent to a heart and the pulmonary vein;

forming a transesophageal ultrasonic image of the pulmonary vein using the ultrasound imaging probe; and

measuring the diameter of the pulmonary vein at the ablation region using the transesophageal ultrasonic image.

19. The method of claim 5, wherein the circumferential ablation device assembly further comprises a linear lesion ablation member adjacent to the circumferential ablation element, said linear lesion ablation member including a linear lesion ablation element, method further comprising:

contacting an elongate region of tissue adjacent to the ablation region with the linear lesion ablation element; and

actuating the linear lesion ablation element and forming a linear lesion in the elongate region of tissue.

20. The method of claim 19, wherein the pulmonary vein ostium is a first ostium of a pair of adjacent ostia formed along the left atrial wall by the pulmonary vein and a second pulmonary vein adjacent to the pulmonary vein, and wherein the linear lesion ablation member has a distal end adjacent to the circumferential ablation member and also has an opposite proximal end located along the distal end portion of the elongate catheter body, said method further comprising:

anchoring the distal end of the linear lesion ablation member with a first anchor by expanding the expandable member to the radially expanded position such that the working length engages the pulmonary vein wall; and

anchoring the proximal end of the linear lesion ablation member with a second anchor in the region of the other of the pair of adjacent ostia.

21. The method of claim 19, wherein the circumferential lesion and the linear lesion are formed such that they intersect at least at one location.

22. The method of claim 5, wherein the distal end portion of the elongate catheter body further comprises a distal guidewire tracking member which is adapted to slideably track and advance over a guidewire, said method further comprising:

advancing a distal guidewire end portion of the guidewire from the left atrium and into the pulmonary vein through the pulmonary vein ostium; and

advancing the distal guidewire tracking member over the guidewire until the circumferential ablation element is located at least in part within the pulmonary vein in the ablation region.

23. The method of claim 22, wherein the distal guidewire tracking member further forms a bore extending between a first distal guidewire port located on the elongate catheter body distally of the working length and a second distal guidewire port located along the elongate catheter body proximally of the distal guidewire port, the distal guidewire tracking member being adapted to slideably track over the guidewire slideably received into the distal bore through the first and second distal guidewire ports, said method further comprising:

slideably coupling the guidewire with the distal guidewire tracking member by engaging the guidewire within the distal bore through the first and second distal guidewire ports.

24. The method of claim 23, wherein the second distal guidewire port is located on the distal end portion of the elongate body, and wherein the guidewire distal end portion is advanced into the pulmonary vein before the guidewire is slideably coupled with the distal guidewire tracking member.

41. A method as recited in claim 1, further comprising forming the circumferential conduction block without delivering an electrical current through an ablative fluid medium.

42. A method as recited in claim 1, further comprising forming the circumferential conduction block without contacting the tissue with an ablative fluid medium that chemically ablates the tissue.

43. A method as recited in claim 1, further comprising forming the circumferential conduction block with an ablation element selected from the group of ablation elements consisting of an ultrasound ablation element, a thermal ablation element, a cryogenic ablation element, a microwave ablation element, and an optical ablation element.

25. A method for treating atrial arrhythmia in a left atrium which includes a left posterior atrial wall having a plurality of pulmonary vein ostia, comprising:

forming a conduction block around a first ostium of the plurality of pulmonary vein ostia from a portion of the left posterior atrial wall which includes at least one of the other pulmonary vein ostia.

26. The method of claim 25, wherein the portion is a first portion, and further comprising forming a conduction block around a second ostium of the plurality of pulmonary vein ostia from a second portion of the left posterior atrial wall which includes at least the first ostium.

27. The method of claim 25, further comprising:

forming a circumferential conduction block along a circumferential path of tissue in the left posterior atrial wall which surrounds the first ostium and which electrically isolates the first ostium from the portion.

28. The method of claim 27, wherein the plurality of pulmonary vein ostia further includes two adjacent ostia which are located vertically and horizontally adjacent to the first ostium, respectively, and further comprising:

forming two linear lesions along the left posterior atrial wall such that each of the linear lesions extends between the first ostium and a different one of the two adjacent ostia,

wherein the circumferential conduction block intersects with and connects the two linear lesions.

29. The method of claim 28, wherein the two linear lesions are formed before forming the circumferential conduction block.

30. The method of claim 28, wherein the two linear lesions are formed after forming the circumferential conduction block.

31. The method of claim 27, wherein the circumferential conduction block is a first circumferential conduction block, the circumferential path of tissue is a first circumferential path of tissue, and the portion is a first portion, and further comprising

forming a second circumferential conduction block along a second circumferential path of tissue in the left posterior atrial wall which surrounds a second ostium and which electrically isolates the second ostium from a second portion of the left posterior atrial wall that includes the first ostium.

32. The method of claim 31, further comprising:

forming a first linear conduction block along a linear path of tissue extending between the first and second ostia and which intersects with the first and second circumferential conduction blocks.

33. The method of claim 31, wherein the first and second circumferential conduction blocks intersect.

34. The method of claim 33, wherein the first and second ostial are vertically adjacent superior and inferior pulmonary vein ostia, respectively.

35. The method of claim 31, wherein the plurality of pulmonary vein ostia further includes third and fourth ostia, and further comprising:

forming a third circumferential conduction block along a third circumferential path of tissue in the left posterior atrial wall which surrounds the third ostium and which electrically isolates the third ostium from a third portion of the left posterior atrial wall which includes the first and second ostia; and

forming a fourth circumferential conduction block along a fourth circumferential path of tissue in the left posterior atrial wall which surrounds the fourth ostium and which electrically isolates the fourth ostium from a fourth portion of the left posterior atrial wall that includes the first, second, and third ostia.

36. The method of claim 35, further comprising:

forming a first linear lesion along the left posterior atrial wall and which intersects with and extends between a first pair of the circumferential conduction blocks; and

forming a second linear lesion along the left posterior atrial wall and which intersects with and extends between a second pair of the circumferential conduction blocks.

37. The method of claim 36, wherein the first and second ostia form a first pair of vertically adjacent pulmonary vein ostia, the third and fourth ostia form a second pair of vertically adjacent pulmonary vein ostia, the first and second circumferential conduction blocks intersect, the third and fourth circumferential conduction blocks intersect, the first pair of the circumferential conduction blocks includes the first and third circumferential conduction blocks, and the second pair of the circumferential conduction blocks includes the second and fourth circumferential conduction blocks.

38. The method of claim 37, wherein a box-shaped conduction block is formed by the combination of the first, second, third, and fourth circumferential conduction blocks and the first and second linear lesions, and wherein the left atrium further comprises a mitral valve annulus, and further comprising:

forming a third linear lesion between the box-shaped conduction block and the mitral valve annulus.

39. The method of claim 36, further comprising:

forming a third linear lesion along the left posterior atrial wall and which intersects with and extends between one of the first pair and one of the second pair of circumferential conduction blocks; and

forming a fourth linear lesion along the left posterior atrial wall and which intersects with and extends between the other of the first pair and the other of the second pair of circumferential conduction blocks.

40. The method of claim 39, wherein a box-shaped conduction block is formed by the combination of the first, second, third, and fourth circumferential conduction blocks and the first and second linear lesions, and wherein the left atrium further comprises a mitral valve annulus, and further comprising:

forming a third linear lesion along the left posterior atrial wall and which extends between the box-shaped conduction block and the mitral valve annulus.

44. A method as recited in claim 27, further comprising forming the circumferential conduction block with an ablation element selected from the group of ablation elements consisting of an ultrasound ablation element, a thermal ablation element, a cryogenic ablation element, a fluid delivery ablation element, a microwave ablation element, and an optical ablation element.