Process for the treatment of atrial arrhythima using a catheter guided by shaped giding introducers

• US 5,690,611 A
• Filed: 11/14/1994
• Issued: 11/25/1997
• Est. Priority Date: 07/08/1994
• Status: Expired due to Term

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: Daig Corporation (Abbott Laboratories Incorporated)
• Inventors: Swartz, John F., Ockuly, John D.
• Primary Examiner(s): Bockelman, Mark
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/337,722
• Time in Patent Office: 1,107 Days
• Field of Search: 128/695, 128/702, 128/705, 604/49, 604/53, 604/281, 607/96, 607/101, 607/115, 607/119, 607/15
• US Class Current: 604/528
• 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 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6855 with a distal curved tip
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems

Abstract

A process for the treatment of atrial arrhythmia by use of ablation and/or mapping procedures comprising ablating discrete ablation tracks within the left and right atrium of the heart by use of precurved left and right atrium guiding introducers, including preferably a guiding introducer system for use in the left atrium comprising an inner and an outer guiding introducer. Also disclosed are shapes for the guiding introducers and the guiding introducer system to be used for the ablation and/or mapping of the discrete tracks within the left and right atrium.

Claims

1. A process for the treatment of atrial arrhythmia within the atria of a human heart by use of ablation and mapping procedures whereby said procedures comprise

(a) introducing into the atria a guiding introducer system comprised of an inner and an outer guiding introducer, each containing a lumen running therethrough and a proximal and a distal end, wherein the inner guiding introducer passes through the lumen of the outer guiding introducer,

(b) introducing into the lumen of the inner guiding introducer an ablation and mapping catheter,

(c) guiding the catheter to a selected location within the atria by use of the inner and outer guiding introducers, and

(d) mapping and ablating the selected location within the atria by use of the catheter.

2. The process of claim 1 wherein the selected location for the ablation is within the left atrium.

3. The process of claim 2 wherein the left atrial appendage is isolated from the pulmonary veins.

4. The process of claim 1 wherein the selected location for the ablation is within the right atrium.

5. The process of claim 1 wherein the selected location is within the left atrium and the right atrium.

6. The process of claim 1 wherein the selected location for ablation comprises a plurality of tracks in the left atrium.

7. The process of claim 6 wherein the ablation of the plurality of tracks results in the following:

(a) isolation of the left atrial appendage from the pulmonary veins;

(b) isolation of the left pulmonary veins from the right pulmonary veins;

(c) isolation of the left interior pulmonary vein from the left superior pulmonary vein; and

(d) isolation of the right interior pulmonary vein from the right superior pulmonary vein.

8. The process of claim 1 wherein the selected location for ablation comprises a plurality of tracks in the right atrium.

9. The process of claim 1 wherein the selected location for ablation comprises a plurality of tracks in the left atrium and the right atrium.

10. The process of claim 1 wherein pharmacological procedures are utilized along with the ablation procedures for the treatment of atrial arrhythmia.

11. The process of claim 1 wherein the ablation procedures utilize one of the energy sources selected from the following:

direct current (high energy, low energy and fulgutronization), radio frequency, microwave, ultrasound, and laser.

12. The process of claim 11 wherein the ablation procedures utilize radio frequency energy.

13. The process of claim 1 wherein the inner guiding introducer is comprised of a first and second sections.

14. The process of claim 1 wherein the inner guiding introducer is comprised of a first, second and third sections.

15. The process of claim 1 wherein the outer guiding introducer is comprised of a first and second sections.

16. The process of claim 1 wherein the outer guiding introducer is comprised of a first, second and third sections.

17. The process of claim 1 wherein the inner guiding introducer is comprised of a first, second and third sections each with proximal and distal ends, wherein the first section is a generally elongated straight section, wherein merged with the distal end of said first section is the second section, wherein the second section is comprised of a first curved portion followed by a first straight portion, wherein the first curved portion is a curve with a radius of about 0.4 to about 0.8 in. which forms an arc of approximately 110°

to about 170°

, wherein the first straight portion is about 1.0 to about 2.0 in. in length, wherein merged with the distal end of the second section is the third section, wherein the third section is comprised of a second curved portion followed by a second straight portion, wherein the second curved portion is curved with a radius of about 0.1 to about 0.5 in. and an arc of about 70°

to about 110°

, and wherein the second straight portion is about 0.5 to about 1.0 in. in length, ending in the distal end of the third section of the inner guiding introducer.

18. The process of claim 17 wherein the outer guiding introducer is comprised of a first and second sections each with proximal and distal ends, wherein the first section is a generally elongated straight section, wherein merged with the distal end of said first section of said outer guiding introducer is the second section which is comprised of a curved section, followed by a straight section, wherein the curved section curves with a radius of about 0.2 to about 0.5 in. and an arc of about 50°

to about 80°

, wherein the straight section is from about 0.2 to about 0.5 in. in length, ending in the distal end of the second section of the outer guiding introducer.

19. The process of claim 1 wherein the inner guiding introducer is comprised of a first and second sections each with proximal and distal ends, wherein the first section is a generally elongated straight section, wherein merged with the distal end of said first section is the second section which is a curved section, curved with a radius of about 0.2 in. to about 0.5 in. to form an arc of approximately 100°

to 140°

, ending in the distal end of the second section of the inner guiding introducer.

20. The process of claim 19 wherein the outer guiding introducer is comprised of a first, second and third sections each with proximal and distal ends, wherein the first section is a generally elongated straight section, wherein merged with the distal end of said first section is the second section which is comprised of a first curved portion followed by a first straight portion, wherein the first curved portion curves with a radius of about 0.3 in. to about 0.7 in. to form an arc of about 20°

to about 60°

, wherein the first straight portion of the second section is about 0.1 to about 0.5 in. in length, wherein merged with the distal end of the second section is the third section which is comprised of a second curved portion followed by a second straight portion, wherein the second curved portion curves with a radius of about 0.2 to about 0.5 in. and an arc of about 30°

to about 70°

, wherein the second straight section is about 0.4 to about 0.9 in. in length, ending in the distal end of the third section of the outer guiding introducer.

21. A process for the treatment of atrial fibrillation within the left side of the heart comprising

(a) introducing into the left side of the heart a guiding introducer system comprised of an inner and an outer guiding introducer, each containing a lumen passing therethrough, a proximal and a distal end;

(b) introducing the inner guiding introducer into the lumen of the outer guiding introducer and extending the distal end of said inner guiding introducer through the lumen of the outer guiding introducer;

(c) introducing into the lumen of the inner guiding introducer a catheter with a distal tip, wherein said catheter has one or more electrodes located at or near the distal tip of the catheter; and

(d) extending said distal tip of the catheter through the lumen of the inner guiding introducer and beyond the distal tip of the inner guiding introducer for treatment of atrial fibrillation.

22. The process of claim 21 wherein the inner guiding introducer is comprised of a first, second and third sections each with proximal and distal ends, wherein the first section is a generally elongated straight section, wherein merged with the distal end of said first section is the second section, wherein the second section is comprised of a first curved portion followed by a first straight portion, wherein the first curved portion is curved with a radius of about 0.4 to about 0.8 cm. to form an arc of approximately 110°

to about 170°

, wherein the first straight portion is about 1.0 to about 2.0 cm. in length, wherein merged with the distal end of the second section is the third section, wherein the third section is comprised of a second curved portion followed by a second straight portion, wherein the second curved portion is curved to the left with a radius of about 0.1 to about 0.5 cm. to form an arc of about 70°

to about 110°

, and wherein the second straight portion is about 0.5 to about 1.0 cm. in length ending in the distal end of the third section of the inner guiding introducer.

23. The process of claim 22 wherein the outer guiding introducer is comprised of a first and second sections, wherein the first section is a generally elongated straight section containing a proximal and distal end, wherein merged with the distal end of said first section is the second section which is comprised of a curved section followed by a straight section, wherein the curved section curves with a radius of about 0.2 to about 0.5 cm. and an arc of about 50°

to about 80°

, wherein the straight section is from about 0.2 to about 0.5 cm. in length ending in the distal end of the second section of the outer guiding introducer.

24. The process of claim 21 wherein the inner guiding introducer is comprised of a first and second sections each with proximal and distal ends, wherein the first section is a generally elongated straight section, wherein merged with the distal end of said first section of said inner guiding introducer is the second section which is a curved section, wherein said curved section is curved in a radius of about 0.2 cm. to about 0.5 cm. to form an arc of approximately 100°

to 140°

, ending in the distal end of the second section of the inner guiding introducer.

25. The process of claim 24 wherein the outer guiding introducer is comprised of a first, second and third sections each with a proximal and distal ends, wherein the first section is a generally elongated straight section, wherein merged with the distal end of said first section is the second section which is comprised of a first curved portion followed by a first straight portion, wherein the first curved portion curves with a radius of about 0.3 cm. to about 0.7 cm. to form an arc of about 20°

to about 60°

, wherein the first straight portion of the second section is about 0.1 to about 0.5 cm. in length, wherein merged with the distal end of the second section is the third section which is comprised of a second curved portion followed by a second straight portion, wherein the second curved portion curves to the right with a radius of about 0.2 to about 0.5 cm. to form an arc of about 30°

to about 70°

, and wherein the second straight section is about 0.4 to about 0.9 cm. in length, ending in the distal end of the third section of the outer guiding introducer.

26. A process for the treatment of atrial arrhythmia which includes the use of ablation and mapping procedures comprising

(a) introducing a precurved, right atrium guiding introducer into the right atrium of a human heart;

(b) positioning a mapping and ablation catheter within the right atrium using the right atrium guiding introducer;

(c) mapping and ablating a preselected track within the right atrium by use of the ablation and mapping catheter and the right atrium guiding introducer;

(d) repeating steps a, b and c as needed using the same or a different precurved, right atrium guiding introducer to ablate and/or map one or more selected tracks within the right atrium;

(e) introducing a guiding introducer system comprised of an inner and outer guiding introducer into the left atrium of a human heart, both inner and outer guiding introducer containing a lumen passing therethrough and a proximal and a distal end, wherein the inner guiding introducer passes through the lumen of the outer guiding introducer;

(f) positioning an ablation and mapping catheter within the left atrium using the guiding introducer system;

(g) mapping and ablating a preselected track within the left atrium by use of the ablation and mapping catheter and the guiding introducer system;

(h) repeating steps e, f and g as needed using the same or different guiding introducer system to ablate one or more preselected tracks within the left atrium.

27. The process of claim 26 wherein the preselected track within the left atrium isolates the left atrial appendage from the pulmonary veins.

28. The process of claim 26 wherein the preselected tracks within the left atrium

(a) isolate the left atrial appendage from the pulmonary veins,

(b) isolate the left pulmonary veins from the right pulmonary veins,

(c) isolate the left interior pulmonary vein from the left superior pulmonary vein, and

(d) isolate the right interior pulmonary vein from the right superior pulmonary vein.

29. The process of claim 28 wherein the left interior pulmonary vein is isolated from a portion of the left atrium.

30. The process of claim 26 wherein the ablation procedure in the left atrium creates four separate tracks designed to divide the left atrium into five discreet sections wherein the first track will extend from the atrioventricular groove at a point anterior to the left pulmonary vein to the interatrial septum, wherein the second track will extend from the interatrial septum to the atrioventricular groove on a course between the right and left pulmonary veins, wherein the third ablation track will extend from a point superior and lateral from the left interior pulmonary vein and extending between the left pulmonary veins to intersect with the second track, and wherein the fourth track will extend from the posterior aspect of the interatrial septum anterior between the right superior and inferior pulmonary veins to intersect the second track.

31. The process of claim 30 wherein a fifth track is created, directed to extend from the fossa ovalis, superior to the septal roof along the interatrial septum.

32. The process of claim 26 wherein ablation tracks in the right atrium are made around the superior vena cava to the inferior vena cava and between the inferior vena cava and the tricuspid valve.

33. The process of claim 26 wherein the ablation tracks in the right atrium comprise a first track along the crista terminals around the superior and inferior vena cava, a second track directed at the tissue separating the tricuspid valve from the inferior vena cava and a third track along the atrio-septal wall between the superior vena cava and the inferior vena cava.

34. The process of claim 33 wherein a fourth track is produced directed from the medial aspect of the superior vena cava near the crista terminalis track anterior to a tip of the right atrial appendage.

35. The process of claim 34 wherein a fifth track is created, designed to extend from the fossa ovalis, superior to the septal roof along the interatrial septum.