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

• US 6,012,457 A
• Filed: 07/08/1997
• Issued: 01/11/2000
• 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): Vu, Mickey
• Assistant Examiner(s): Nguyen, Dinh X.
• Application Number:
  US08/889,835
• Time in Patent Office: 917 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, 601/2
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2018/00011 with fluids
• 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 2018/0016 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 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• 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 2018/00369 Heart valves
• 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 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 : measured by a thermistor
• 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 2018/00898 : Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/00994 : combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
• CPC Class Codes: A61B 2018/1407 : Loop
• CPC Class Codes: A61B 2218/002 : Irrigation
• 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

This is a method for treating a patient diagnosed with atrial arrhythmia by forming a circumferential conduction block along a circumferential path of tissue in a pulmonary vein wall that circumscribes the pulmonary vein lumen and transects the electrical conductivity of the pulmonary vein such that conduction is blocked along the longitudinal axis of the vein wall and into the left atrial wall. The method is performed to treat a patient with a focal arrythmogenic origin along the pulmonary vein wall by either ablating the focal origin or by isolating the focal origin from the atrial wall with the circumferential conduction block. The circumferential conduction block is also formed in a pulmonary vein in order to bridge the adjacent ends of two linear lesions, wherein each linear lesion is formed to extend between the pulmonary vein and another adjacent pulmonary vein in a less-invasive "maze"-type procedure. A circumferential ablation element in a circumferential ablation device assembly is used in a percutaneous translumenal catheter technique in order to form the circumferential conduction block in the pulmonary vein wall.

Claims

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

introducing a circumferential ablation member into the left atrium, said circumferential ablation member comprising an expandable member and an ablation element;

positioning the circumferential ablation member along a location where a pulmonary vein extends from the left atrium;

expanding the expandable member until the expandable member engages a circumferential region of tissue along the location; and

ablating the circumferential region of tissue with the circumferential ablation element while the expandable member is expanded and engaged to the circumferential region of tissue.

2. The method of claim 1, wherein the left atrial arrhythmia originates at least in part from an arrhythmogenic origin located along the pulmonary vein, and further comprising ablating the circumferential region of tissue at the location which includes the arrhythmogenic origin.

3. The method of claim 1, wherein the left atrial arrhythmia originates at least in part from an arrhythmogenic origin located along the pulmonary vein, and further comprising ablating the circumferential region of tissue at the location which is between the arrhythmogenic origin and the left atrium, such that the left atrium is electrically isolated from the arrhythmogenic origin.

4. The method of claim 1, further comprising:

forming a circumferential lesion by ablating the circumferential region of tissue such that the circumferential lesion has a lesion width and also a lesion circumference, wherein the lesion width is less than two-thirds the lesion circumference.

5. The method of claim 1, further comprising ablating the circumferential region of tissue at the location which includes the pulmonary vein ostium.

6. The method of claim 1, further comprising:

monitoring electrical conduction signals along the pulmonary vein; and

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

7. The method of claim 6, further comprising:

selecting the location at a position between the identified origin of atrial arrhythmia and the left atrium.

8. The method of claim 1, further comprising engaging the expandable member with the circumferential region of tissue by:

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

advancing the expandable member when in the radially expanded position toward the pulmonary vein until the expandable member engages the pulmonary vein wall.

9. The method of claim 1, wherein the expandable member further comprises a balloon which is fluidly coupled to a pressurizeable fluid source, and further comprising:

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

10. The method of claim 1, further comprising forming a circumferential lesion by ablating the circumferential region of tissue such that the circumferential lesion has a lesion width which is less than two-thirds of a working length of the expandable member.

11. The method of claim 1, further comprising:

allowing antegrade blood flow to perfuse from the pulmonary vein and into the left atrium through the location when engaging the expandable member with the circumferential region of tissue and also while ablating the circumferential region of tissue with the circumferential ablation element.

12. The method of claim 1, further comprising:

providing a plurality of circumferential ablation device assemblies, each having a circumferential ablation member with a circumferential ablation element and also an expandable member with a different expanded outer diameter than the other expandable members; and

measuring an inner diameter along the location; and

selecting one of the circumferential ablation device assemblies for ablating the circumferential region of tissue based upon comparing the expanded outer diameter of the selected circumferential ablation device assembly with the measured inner diameter.

13. The method of claim 12, further comprising:

measuring the inner diameter along the location at the pulmonary vein ostium; and

engaging the expandable member with the pulmonary vein ostium while ablating the circumferential region of tissue with the circumferential ablation element.

14. The method of claim 12, further comprising:

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

forming an X-ray image of the location while the contrast material flows along the location; and

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

15. The method of claim 12, further comprising:

inserting an ultrasound imaging probe into a region adjacent to the location;

forming an ultrasonic image of the location using the ultrasound imaging probe; and

measuring the inner diameter using the ultrasonic image.

16. The method of claim 1, further comprising:

ablating an elongate region of tissue located along a left atrial wall of the left atrium with a linear lesion ablation element provided along a linear lesion ablation member.

17. The method of claim 16, further comprising:

coupling a first end portion of the linear lesion ablation member to the circumferential ablation member;

anchoring the first end portion of the linear lesion ablation member by positioning an expandable member provided along the circumferential ablation member within the pulmonary vein and expanding the expandable member to a radially expanded position to thereby engage the pulmonary vein; and

anchoring a second end portion of the linear lesion ablation member with a second anchor positioned at least in part within another pulmonary vein; and

ablating the elongate region of tissue with a linear lesion ablation member provided between the first and second ends along the linear lesion ablation member.

18. The method of claim 16, further comprising

forming a circumferential lesion by ablating the circumferential region of tissue;

and

forming a linear lesion by ablating the elongate region of tissue, wherein the circumferential lesion and the linear lesion are formed such that they intersect.

19. The method of claim 1, further comprising:

advancing a guidewire from the left atrium and into the pulmonary vein; and

tracking a guidewire tracking member coupled to the circumferential ablation member over the guidewire until the circumferential ablation member is positioned along the location.

20. The method of claim 19, wherein the guidewire tracking member further forms a bore extending between a distal guidewire port located on the elongate catheter body distally of the working length and a proximal guidewire port located along the elongate catheter body proximally of the distal guidewire port, the guidewire tracking member being adapted to slideably track over the guidewire received into the distal bore through the distal and proximal guidewire ports, said method further comprising:

coupling the guidewire with the guidewire tracking member by engaging the guidewire within the bore through the distal and proximal guidewire ports.

21. The method of claim 20, further comprising positioning the guidewire at least in part within the pulmonary vein before coupling the guidewire with the guidewire tracking member.

22. The method of claim 1, wherein the ablation element is located at least in part within and is at least in part surrounded by the expandable member, and further comprising:

ablating the circumferential region of tissue by ablatively coupling the circumferential ablation element with the circumferential region of tissue through the expandable member.

23. The method of claim 22, wherein the expandable member comprises a wall, and further comprising:

contacting the circumferential region of tissue with the wall when the expandable member is expanded; and

ablating the circumferential region of tissue by ablatively coupling the circumferential ablation element with the circumferential region of tissue through the wall of the expandable member.

24. The method of claim 1, wherein the expandable member comprises an outer surface and the ablation element is located at least in part along the outer surface, and further comprising:

contacting at least a portion of the circumferential region of tissue with the ablation element when the expandable member is expanded;

ablating the circumferential region of tissue with the ablation element while the ablation element is in contact with at least the portion of the circumferential region of tissue.

25. The method of claim 1, wherein the expandable member comprises first and second end portions and an intermediate region therebetween, and further comprising:

engaging the first and second end portions with first and second adjacent regions of tissue, respectively, located on opposite sides of the circumferential region of tissue while engaging only the intermediate region with the circumferential region of tissue; and

ablatively coupling the circumferential ablation element to only a circumferential area that surrounds the intermediate region such that only the circumferential region of tissue is ablated when the intermediate region is engaged to the circumferential region of tissue and the first and second end portions are respectively engaged with the first and second adjacent regions of tissue.

26. The method of claim 1, further comprising:

engaging the expandable member with the circumferential region of tissue by positioning the expandable member along the location in a radially collapsed position and then expanding the expandable member from the radially collapsed condition to a radially expanded position which engages the circumferential region of tissue.

27. The method of claim 1, wherein the ablation element comprises an ultrasound ablation element, and further comprising:

ablating the circumferential region of tissue at least in part by energizing the ultrasound ablation element to ultrasonically couple to the circumferential region of tissue.

28. The method of claim 1, wherein the ablation element comprises a thermal ablation element, and further comprising:

ablating the circumferential region of tissue at least in part by thermally coupling the thermal ablation element to the circumferential region of tissue.

29. The method of claim 1, wherein the ablation element comprises a cryogenic ablation element, and further comprising:

ablating the circumferential region of tissue at least in part by activating the cryogenic ablation element to cool the circumferential region of tissue.

30. The method of claim 1, wherein the ablation element comprises a fluid delivery ablation element, and further comprising:

ablating the circumferential region of tissue at least in part by exposing an ablative fluid from the fluid delivery element to the circumferential region of tissue.

31. The method of claim 1, wherein the ablation element comprises a microwave ablation element, and further comprising:

ablating the circumferential region of tissue at least in part by inductively coupling the microwave ablation element with the circumferential region of tissue.

32. The method of claim 1, wherein the ablation element comprises an optical ablation element, and further comprising:

ablating the circumferential region of tissue at least in part by optically coupling the optical ablation element with the circumferential region of tissue.