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

• US 20030065307A1
• Filed: 08/30/2002
• Published: 04/03/2003
• Est. Priority Date: 05/09/1997
• Status: Active Grant

• Current Assignee: Michael D. Lesh
• Original Assignee: Michael D. Lesh
• Inventors: Lesh, Michael D.
• Granted Patent: US 7,044,135 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• 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 invention 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 atrial arrhythmia comprising forming a circumferential conduction block in a pulmonary vein,

wherein the pulmonary vein has a longitudinal axis, a pulmonary vein wall, a pulmonary vein lumen, a pulmonary vein ostium located along a left atrial wall of a left atrium, and electrical conductivity along the pulmonary vein wall relative to the longitudinal axis, and wherein

the circumferential conduction block formed is continuous along a circumferential region of tissue along the pulmonary vein wall and thereby circumscribes the pulmonary vein lumen and transects the electrical conductivity of the pulmonary vein by blocking electrical conduction along the longitudinal axis.

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 guide wire 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 guide wire 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.