Process for the nonsurgical mapping and treatment of atrial arrhythmia using catheters guided by shaped guiding introducers

• US 5,575,766 A
• Filed: 07/08/1994
• Issued: 11/19/1996
• Est. Priority Date: 11/03/1993
• Status: Expired due to Term

• Current Assignee: St. Jude Medical, Atrial Fibrillation Division, Inc. (Abbott Laboratories)
• Original Assignee: Daig Corporation (Abbott Laboratories)
• Inventors: Swartz, John F., Ockuly, John
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/272,014
• Time in Patent Office: 865 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, 600/15-17
• US Class Current: 604/508
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04

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. Also disclosed are shapes for the guiding introducers 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

introducing into the atria a precurved, guiding introducer, wherein said introducer contains a proximal and a distal end and a lumen running within said guiding introducer from proximal to distal ends,

introducing into said lumen of said guiding introducer an ablation and mapping catheter,

guiding the catheter to a selected area of the atria by use of the guiding introducer, wherein a portion of said catheter extends out the distal end of the lumen of the guiding introducer, and

mapping and ablating the selected area of the atria by use of the catheter thereby producing an ablation track.

2. The process of claim 1 wherein the selected area 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 2 wherein five guiding introducers are utilized for the ablation procedures in the left atrium.

5. The process of claim 1 wherein the selected area for the ablation is within the right atrium.

6. The process of claim 1 wherein the selected area is within the left atrium and the right atrium.

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

8. The process of claim 7 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.

9. The process of claim 8 wherein five guiding introducers are utilized for the ablation procedures in the left atrium.

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

11. The process of claim 10 wherein the area for ablation within the right atrium comprises tracks around the superior vena cava to the inferior vena cava and between the inferior vena cava and the tricuspid valve.

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

13. The process of claim 1 wherein pharmacological procedures are utilized along with the ablation procedures to assist in the treatment of atrial arrhythmia.

14. The process of claim 1 wherein the ablation procedures utilize one of the following:

direct current, radio frequency, microwave, ultrasound, laser procedures, and fulgutronization procedures as the source for the ablation.

15. The process of claim 14 wherein the ablation procedures are performed utilizing radio frequency energy.

16. The process of claim 1 wherein noncurved guiding introducers, as well as the precurved, guiding introducer are utilized in conjunction with the catheter to assist in the treatment of atrial arrhythmia.

17. The process of claim 1 wherein the guiding introducer is tapered at the distal end.

18. The process of claim 1 wherein the guiding introducer has vent holes near a distal tip of the guiding introducer.

22. The process of claim 7 wherein the left interior pulmonary vein is isolated from the remaining portion of the left atrium.

19. 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, wherein said guiding introducer contains a proximal and distal ends and a lumen running within said guiding introducer from proximal to distal ends;

(b) positioning a mapping and ablation catheter within the right atrium using the right atrium guiding introducer, wherein a portion of said catheter extends out the distal end of the lumen of the 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 map one or more selected tracks within the right atrium;

(e) introducing a precurved, left atrium guiding introducer into the left atrium of a human heart, wherein said guiding introducer contains a proximal and distal ends and a lumen running within said guiding introducer from proximal to distal ends;

(f) positioning an ablation and mapping catheter within the left atrium using the left atrium guiding introducer, wherein a portion of said catheter extends out the distal end of the lumen of the guiding introducer;

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

(h) repeating steps e, f and g as needed using the same or different guiding introducers to ablate one or more preselected tracks within the left atrium, thereby creating a generally uninterrupted pathway for electrical impulses from the sinoatrial node to the atrioventricular node while also permitting atrial contraction mediated by the SA node, as well as enhanced atrioventricular synchrony.

20. The process of claim 19 wherein the preselected track within the left atrium isolates the left atrial appendage from the pulmonary veins.

21. The process of claim 19 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.

23. The process of claim 19 wherein the ablation and mapping 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.

24. The process of claim 23 wherein a fifth track is created, directed to extend from the fossa ovalis, superior to the septal roof along the interatrial septum.

25. The process of claim 19 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.

26. The process of claim 19 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.

27. The process of claim 26 wherein a fourth track is produced directed from the medial aspect of the superior vena cava at the crista terminalis track anterior to the right atrial appendage.

28. The process of claim 27 wherein a fifth track is created, designed to extend from the fossa ovalis, superior to the septal roof along the interatrial septum.

29. 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

introducing into the atria a precurved, guiding introducer, wherein said introducer contains a proximal and a distal end,

introducing into said guiding introducer an ablation and mapping catheter,

guiding the catheter to a selected area of the atria by use of the guiding introducer, wherein the selected area for ablation comprises a plurality of tracts in the left atrium, and

mapping and ablating the selected area of the atria by use of the catheter, thereby producing an ablation track.

30. The process of claim 29 wherein the left atrial appendage is isolated from the pulmonary veins.

31. The process of claim 29 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 form the right superior pulmonary vein.

32. The process of claim 31 wherein five guiding introducers are utilized for the ablation procedures in the left atrium.

33. The process of claim 29 wherein noncurved guiding introducers, as well as precurved, guiding introducers may be utilized in conjunction with the ablation catheter to assist in the treatment of atrial arrhythmia.

34. The process of claim 29 wherein five guiding introducers are utilized for the ablation procedures in the left atrium.

35. The process of claim 29 wherein the guiding introducer has vent holes near the distal end of the guiding introducer.

36. 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

introducing into the atria a precurved, guiding introducer, wherein said introducer contains a proximal and a distal end,

introducing into said guiding introducer an ablation and mapping catheter,

guiding the catheter to a selected area of the atria by use of the guiding introducer, wherein the selected area for ablation comprises a plurality of tracks in the right atrium, and

mapping and ablating the selected area of the atria by use of the catheter.

37. The process of claim 36 wherein the area for ablation within the right atrium comprises tracks around the superior vena cava to the inferior vena cava and between the inferior vena cava and the tricuspid valve.

38. The process of claim 36 wherein noncurved guiding introducers, as well as precurved, guiding introducers may be utilized in conjunction with the ablation catheter to assist in the treatment of atrial arrhythmia.

39. The process of claim 36 wherein the guiding introducer has vent holes near the distal end of the guiding introducer.

40. 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

introducing into the atria a precurved, guiding introducer, wherein said introducer contains a proximal and a distal end,

introducing into said guiding introducer an ablation and mapping catheter,

guiding the catheter to a selected area of the atria by use of the guiding introducer, wherein the selected area for ablation comprises a plurality of tracks in the left atrium and the right atrium, and

mapping and ablating the selected area of the atria by use of the catheter.

41. The process of claim 40 wherein noncurved guiding introducers, as well as precurved, guiding introducers may be utilized in conjunction with the ablation catheter to assist in the treatment of atrial arrhythmia.

42. The process of claim 40 wherein the guiding introducer has vent holes near the distal end of the guiding introducer.