Mapping and ablation catheter system

• US 5,687,723 A
• Filed: 06/08/1995
• Issued: 11/18/1997
• Est. Priority Date: 12/03/1993
• Status: Expired due to Term

• Current Assignee: Boaz Avitall
• Original Assignee: Boaz Avitall
• Inventors: Avitall, Boaz
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US08/487,492
• Time in Patent Office: 894 Days
• Field of Search: 128/642, 607/98, 607/99, 607/101, 607/122, 607/125, 607/126, 607/127, 606/41
• US Class Current: 600/374
• CPC Class Codes: A61B 18/14 Probes or electrodes 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 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00029 open
• 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 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 2562/043 in a linear array
• 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: A61B 5/6856 : with a distal loop
• CPC Class Codes: A61B 5/6859 : with multiple distal splines
• CPC Class Codes: A61N 1/06 : for high-frequency therapy

Abstract

A recording and ablation catheter method and system for creating linear lesions in an atrial or other cardiac chamber of interest is described which includes an array of readily controlled electroded arcuate distal working catheter shapes that are easily deployed to contact the desired inner wall surface of a cardiac chamber in a manner that enables easy recording and mapping of impulses and thereafter facilitates sustained contact so that linear lesions can be produced from an array of mapping and ablation electrode devices serially spaced along the working catheter shape. Auxiliary cooling may also be provided.

Claims

1. A recording and ablation system for accessing a cardiac chamber of interest, mapping, creating linear ablation lesions in said cardiac chamber of interest comprising:

(a) a guide member for aiding the navigation of a catheter or sheath in the vascular system of a patient, and for threading through a guide member eye said guide member comprising a distal stop means for containing the distal travel of a guide member eye, threaded thereover;

(b) a hollow outer catheter or sheath having a distal opening;

(c) an inner catheter member carried by and operable within said outer catheter or sheath and including a flexible distal recording and ablation device having a working electroded section extendable to protrude from a distal opening in said outer catheter or sheath, said working electroded section being axially adjustable relative to said guide member and having at least a distal guide member eye slidably threaded over said guide member to said distal stop means such that the electroded section proximal said distal guide is member eye can be adjustably arcuately flexed outward according to the relative motion of said distal guide member eye and said electroded section protruding from said distal opening to produce a desired shape to address an inner surface of said chamber of interest; and

(d) a plurality of spaced serial electrodes carried by said electroded section of said recording and ablation device.

2. The apparatus of claim 1 wherein said outer catheter or sheath is a sheath and further comprises a directional sheath deflection system proximal said distal opening for enhancing control of the shape assumed by the sheath proximal to said distal opening.

3. The apparatus of claim 2 wherein said directional sheath deflection system further comprises a double directional sheath system having inner and outer concentric sheath layers having radially diverse directional tendencies, wherein one of said directional sheath layers extends distally beyond the other to produce a compound deflection curve.

4. The apparatus of claim 2 further comprising means for controlling the deflection of said directional sheath deflection system.

5. The apparatus of claim 3 further comprising means for controlling the deflection of said directional sheath deflection system.

6. The apparatus of claim 1 wherein said serial electrodes are selected from the group consisting of ring and bead electrodes and are provided with cooling openings or ports.

7. The apparatus of claim 6 further comprising a cooling device comprising fluid infusion means selectively connected to said cooling ports.

8. The apparatus of claim 1 further comprising a cooling device for cooling said electrodes comprising fluid infusion means.

9. The apparatus of claim 8 wherein said cooling device further comprises:

(a) elongated infusion tube means disposed movably inside said outer catheter or sheath and extending substantially the length thereof including said working electroded section, said infusion tube means having a proximal infusion port for receiving cooling fluid and a plurality of distal effusion openings;

(b) wherein said working electroded section and said plurality of electrodes are provided with a plurality of spaced aligned effusion pores or cooling ports such that relative motion of the infusion tube and the working electroded section can align the effusion openings of the infusion tube means with the cooling ports in the electrodes to allow effusion of cooling fluid.

10. The apparatus of claim 1 further comprising an intermediate control element attached to said working electroded section of said recording and ablation device intermediate the ends thereof for modifying the shape of the working electroded section.

11. The apparatus of claim 10 wherein said intermediate control element is an independently operable tensioning element.

12. The apparatus of claim 1 further comprising radiopaque marker means on the distal end of said outer catheter or sheath.

13. The apparatus of claim 12 wherein said radiopaque marker means is asymmetrical.

14. The apparatus of claim 1 further comprising a semi-rigid tube member threaded over said guide member proximal said guide member eye.

15. The apparatus of claim 14 wherein said semi-rigid tube member is non-linear.

16. The apparatus of claim 1 wherein said guide member is designed with sufficient rigidity to penetrate a heart septum wall prior to deployment of said working electroded section and is retractable back through said septum after a procedure is completed.

17. The apparatus of claim 14 further comprising an intermediate control element attached to said working electroded section of said recording and ablation device intermediate the ends thereof for modifying the shape of the working electroded section.

18. The apparatus of claim 17 wherein said intermediate control element is an independently operable tensioning element.

19. A recording and ablation catheter system for a vascular cardiac catheter for creating linear lesions to produce segmentation in a cardiac chamber comprising:

(a) an elongated outer catheter or sheath having a distal end and an opening in said distal end;

(b) a vascular navigating guide member disposed to protrude from said distal end of said catheter or sheath;

(c) an inner catheter carried by and operable within said outer catheter or sheath comprising a single member flexible distal working catheter or spine section having a proximal and a distal end and a guide member eye proximate said distal end, said inner catheter deployed over said guide member from said opening in the distal end of said outer catheter or sheath and a plurality of spaced, separately connected, serially situated electrodes on said single member working catheter or spine section;

(d) shaping means for causing said working catheter section to assume an adjustable posture enabling positioning for the production of substantially linear ablation lesions along a predetermined line of a cardiac chamber surface using said spaced electrodes, said shaping means further comprising;

(1) travel limiting means on said guide member for limiting travel of the distal end of the guide member eye so that further relative distal axial displacement of a more proximal portion of the distal working catheter section produces an arcuate protrusion thereof, and

(2) an intermediate shaping control means comprising at least one intermediate shaping control element connected to said working catheter section at a distance proximal said guide member eye and operable to modify the shape of said working catheter section.

20. The apparatus of claim 19 wherein said intermediate shaping control element is an independently operable tensioning element.

21. The apparatus of claim 19 wherein said intermediate shaping means contains a plurality of intermediate shaping control elements.

22. The apparatus of claim 21 wherein each said intermediate control element is an independently operable tensioning element.

23. The apparatus of claim 19 further comprising semi-rigid tube member threaded over said guide member proximal said guide member eye.

24. The apparatus of claim 23 wherein said intermediate control element is an independently operable tensioning element.

25. The apparatus of claim 19 further comprising means for cooling said electrodes.

26. The apparatus of claim 25 wherein said cooling means further comprises:

(a) elongated infusion tube means disposed movably inside said outer catheter or sheath and extending substantially the length thereof including said working electroded section, said infusion tube means having a proximal infusion port for receiving cooling fluid and a plurality of distal effusion openings;

(b) wherein said working electroded section and said plurality of electrodes are provided with a plurality of spaced aligned effusion pores or cooling ports such that relative motion of the infusion tube means and the working electroded section can align the effusion openings of the infusion tube with the cooling ports in the electrodes to allow effusion of cooling fluid.

27. A recording and ablation system for accessing a cardiac chamber of interest, mapping, creating linear ablation lesions in said cardiac chamber of interest comprising:

(a) a hollow outer catheter or sheath having a distal opening;

(b) an elongate inner catheter system inserted and operable in said hollow outer catheter or sheath and having a proximal and a distal area, the distal area of said inner catheter system comprising an electroded section extendable to protrude from said distal opening in said outer catheter or sheath, said electroded section being axially adjustable relative to said catheter or sheath;

(c) wherein said electroded section comprises a plurality of serially spaced electrodes;

(d) a plurality of individually controllable control tensioning elements each having a distal end and a proximal end, the distal end of each being connected to said electroded section at spaced intervals therealong, the axial displacement of which at the proximal end thereof produces corresponding deflection changes in said electroded section.

28. A method of mapping and ablating tissue in the left atrial cardiac chamber of a heart having right and left atrial chambers using a vascular catheter or sheath comprising the steps of:

(a) navigating a hollow catheter or sheath, said hollow catheter or sheath having a distal end and an opening in said distal end and carrying there within a deployable flexible distal working catheter section, through the vascular system of a patient of interest;

(b) causing the distal end of the catheter to enter the right atrial chamber through a vessel selected from the group consisting of the superior vena cava and the inferior vena cava;

(c) wherein said catheter or sheath comprises;

(1) a vascular navigating guidewire disposed to protrude from a distal end of said catheter or sheath;

(2) a single member flexible working catheter section having a proximal and a distal end and adapted to be deployed from said catheter or sheath via a lumen therein for containing said working catheter section and a plurality of spaced separately connected serially situated electrodes on said single member working catheter section;

(3) means for causing said working catheter section to assume an arcuate shape of controlled curvature for contacting an internal surface of said chamber and assuming an adjustable posture enabling positioning for the production of substantially linear ablation lesions along a predetermined line of the chamber surface using said plurality of spaced electrodes;

(d) causing said guidewire to penetrate from said right atrial chamber into the left atrial chamber through the atrial septum in a manner such that the working catheter section can be deployed in said left atrial chamber;

(e) causing the distal end of the working catheter section to assume a controlled curvature in contact with a desired inner atrial surface of said left atrial chamber such that a relatively linear ablation lesion of a predetermined length can be formed by energizing a plurality of said spaced serial electrodes;

(f) adjusting and positioning said working catheter section to ablate desired areas of said inner atrial surface;

(g) ablating tissue to form linear lesions where indicated; and

(h) reversing steps (d), (b) and (a).

29. The method of claim 28 further comprising the step of adjusting the length of said working catheter section deployed in the left atrial chamber.

30. The method of claim 29 further comprising the step of adjusting and positioning and using said working catheter section to map electrical activity prior to ablation to determine correct ablation locations.

31. The method of claim 28 further comprising the step of adjusting and positioning and using said working catheter section to map electrical activity prior to ablation to determine correct ablation locations.

32. The method of claim 28 further comprising the step of causing the distal end of said guidewire to enter a pulmonary vein prior to deploying said working catheter section to aid in positioning said working catheter section in said chamber.

33. The method of claim 28 further comprising the step of directing the distal end of said guidewire through a mitral valve prior to deploying said working catheter section to aid in positioning said working catheter section in said left atrial chamber.

34. The method of claim 33 further comprising the step of adjusting and positioning and using said working catheter section to map electrical activity prior to ablation to determine correct ablation locations.

35. The method of claim 32 further comprising the step of adjusting and positioning and using said working catheter section to map electrical activity prior to ablation to determine correct ablation locations.

36. The method of claim 28 wherein said catheter or sheath is caused to enter through the inferior vena cava.

37. The method of claim 28 comprising the step of flowing fluid coolant from cooling ports in said electrodes to cool said electrodes.

38. A method of mapping and ablating tissue in the left atrial cardiac chamber of a heart including a left atrial chamber and a left ventricle chamber separated by a mitral valve using a vascular catheter or sheath comprising the steps of:

(a) navigating a catheter or sheath having a distal end and carrying a deployable flexible distal working catheter section through the vascular system of a patient of interest;

(b) causing the distal end of the catheter to enter the left ventricle chamber through the aortic arch and proceed into the left atrial chamber through the mitral valve;

(c) wherein said catheter or sheath comprises;

(1) a vascular navigating guidewire disposed to protrude from a distal end of said catheter or sheath;

(2) a single member flexible working catheter section having a proximal and a distal end and adapted to be deployed from said catheter or sheath via a lumen therein for containing said working catheter section and a plurality of spaced separately connected serially situated electrodes on said single member working catheter section;

(3) means for causing said working catheter section to assume an arcuate shape of controlled curvature for contacting an internal surface of said chamber and assuming an adjustable posture enabling positioning for the production of substantially linear ablation lesions along a predetermined line of the chamber surface using said plurality of spaced electrodes;

(d) causing the distal area of the working catheter section to assume a controlled curvature in contact with a desired inner atrial surface of said left atrial chamber such that a relatively linear ablation lesion of a predetermined length can be formed by energizing a plurality of said spaced serial electrodes;

(e) adjusting and positioning said working catheter section to ablate desired areas of said inner atrial surface;

(f) ablating tissue to form linear lesions where indicated; and

(g) reversing steps (b) and (a).

39. The method of claim 38 further comprising the step of causing the distal end of said guidewire to enter a pulmonary vein prior to deploying said working catheter section to aid in positioning said working catheter section in said chamber.

40. The method of claim 38 further comprising the step of adjusting the length of said working catheter section deployed in the left atrial chamber.

41. The method of claim 39 further comprising the step of adjusting the length of said working catheter section deployed in the left atrial chamber.

42. The method of claim 38 further comprising the step of adjusting and positioning and using said working catheter section to map electrical activity prior to ablation to determine correct ablation locations.

43. The method of claim 39 further comprising the step of adjusting and positioning and using said working catheter section to map electrical activity prior to ablation to determine correct ablation locations.