Electrode array catheter

• US 5,938,694 A
• Filed: 02/21/1996
• Issued: 08/17/1999
• Est. Priority Date: 11/10/1993
• Status: Expired due to Term

• Current Assignee: Medtronic Cardiorhythm (Medtronic Plc)
• Original Assignee: Medtronic Cardiorhythm (Medtronic Plc)
• Inventors: Reyes, Ramiro L., Jaraczewski, Richard S., Maguire, Mark A., Ladd, Kevin C.
• Primary Examiner(s): Casler, Brian L.
• Application Number:
  US08/603,561
• Time in Patent Office: 1,273 Days
• Field of Search: 128/642, 607/122, 607/125, 607/126, 607/127, 607/119, 607/101, 607/102, 607/116, 607/118, 607/148, 600/373
• US Class Current: 607/122
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 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 2018/00577 Ablation
• 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 2018/1425 Needle
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1432 curved
• CPC Class Codes: A61B 2018/1435 Spiral
• 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 5/6852 Catheters
• CPC Class Codes: A61B 5/6855 with a distal curved tip
• CPC Class Codes: A61B 5/6857 with a distal pigtail shape
• CPC Class Codes: A61B 5/6859 with multiple distal splines
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/06 : for high-frequency therapy

Abstract

An electrode array catheter, typically used for mapping, pacing and ablation, includes a flexible delivery sheath (36, 64) and an electrode assembly (2, 62) slidably mounted within the delivery sheath for movement between retracted and deployed positions. The electrode assembly includes an ablation electrode (10, 90) and a plurality of mapping electrodes (26, 114) which are grouped in pairs and naturally assume a three-dimensional array when deployed. The electrodes are distributed to contact a portion of the chamber wall (130) surrounding the target site. The electrode assembly tip has a coiled conical shape (24) in one embodiment and has a number of axially extending, radially outwardly curved arms (118) in another embodiment. A flat flexible circuit (110), having axially extending electrode traces (112) connecting proximal terminals (108) to distal electrode pads (114), is slit (116) axially and is preformed and to create the curved arms.

Claims

1. A steerable electrode array catheter, for insertion into a heart chamber for placement of multiple electrodes against the heart chamber wall in the vicinity of a target site, comprising:

an electrode assembly including a distal end, said distal end comprising;

a free, unattached tip;

an elongate electrode body which naturally assumes a curved shape when in an unconstrained, deployed position, said curved shape having one or more curved regions curving substantially more than 360°

;

at least four electrodes mounted to the electrode body and positioned over more than about 360°

of the one or more curved regions of the electrode body, said electrodes being electrically isolated from one another and naturally assuming an array when said distal end is unconstrained, said electrodes distributed along said distal end to be able to contact a portion of the chamber wall surrounding the target site, said portion being substantially less than the entire chamber wall;

means for steering the distal end of the electrode assembly within the heart chamber to the target site; and

a flexible delivery sheath having a hollow interior, a proximal end and a distal end, the electrode assembly slidably mounted within the hollow interior of the delivery sheath for movement between a retracted position, at least substantially housed within the hollow interior, and a deployed position, extending from the distal end of the delivery sheath, the delivery sheath having an electrode at said distal end of the delivery sheath.

2. The catheter of claim 1 wherein the electrode assembly includes an ablation electrode.

3. The catheter of claim 2 wherein the ablation electrode includes a temperature sensing means for sensing the temperatures at a position adjacent the ablation electrode.

4. The catheter of claim 2 wherein the length of the ablation electrode is about 1 to 10 mm.

5. The catheter of claim 1 wherein at least some of said electrodes are arranged in pairs.

6. The catheter of claim 5 wherein the electrodes in said electrode pairs are spaced apart by about 0.5 mm-10 mm.

7. The catheter of claim 1 wherein said array is a three-dimensional array.

8. The catheter of claim 1 wherein said array is a two-dimensional array.

9. The catheter of claim 1 wherein the steering means includes means for directly deflecting the distal end of the electrode assembly.

10. The catheter of claim 9 wherein the directly deflecting means deflects the distal end of the electrode assembly laterally.

11. The catheter of claim 1 wherein the steering means includes means for deflecting the distal end of the delivery sheath.

12. The catheter of claim 11 wherein the deflecting means deflects the distal end of the delivery sheath laterally.

13. The catheter of claim 1 wherein the steering means includes means for rotating at least the distal end of the electrode assembly within the delivery sheath.

14. The catheter of claim 1 wherein the one or more curved regions curve about 720°

.

15. The catheter of claim 1 wherein the electrode body is a resilient electrode body which includes a super-elastic NiTi spring material.

16. The catheter of claim 1 wherein at least substantially all of the electrodes are paired, said pairs being spaced apart along the electrode body.

17. The catheter of claim 1 wherein the electrode body naturally assumes a distally-extending, three-dimensional, coiled, conical shape when in the deployed position.

18. The catheter of claim 17 wherein the distally-extending, three-dimensional, coiled, conical shape is a diverging coiled conical shape.

19. The catheter of claim 1 wherein the electrode assembly includes at least one pair of ablation electrodes.

20. A method for performing an electrophysiology procedure at a target site within a heart chamber comprising the following steps:

selecting an electrode array catheter having a distal end, movable between constrained and unconstrained conditions, the distal end comprising a tip and an elongate electrode body, which naturally assumes a distally-extending, three-dimensional, coiled, conical shape when the distal end is in the unconstrained condition, said curved shape having one or more curved regions curving substantially more than 360°

, the one or more curved regions of the electrode body comprising at least four electrodes electrically isolated from one another and arranged in distally-extending, three-dimensional, coiled, conical array when said distal end is in the unconstrained condition;

steering the distal end into the heart chamber;

unconstraining the distal end so that the electrode body assumes said curved shape with said curved regions curving substantially more than 360°

, said electrodes extend over more than about 360°

of the electrode body and said tip being free and unattached;

directing the array of electrodes against the endocardial wall within the heart chamber to the target site by remotely deflecting the distal end within the heart chamber; and

performing a chosen electrophysiology procedure, said distally-extending, three-dimensional, coiled, conical curved shape of the distal end chosen so each said electrode engages the endocardial wall at the target site.

21. The procedure of claim 20 wherein the selecting step is carried out by selecting an electrode array catheter which has said array of electrodes sized to cover substantially less than the entire endocardial wall when said distal end is unconstrained.

22. The procedure of claim 20 further comprising the step of deploying, once the distal end is within the heart chamber, the distal end from the constrained condition to the unconstrained condition to permit said electrodes to assume said array.

23. The procedure of claim 20 wherein the remotely deflecting step is carried out by deflecting a distal end of a delivery sheath.

24. The procedure of claim 20 wherein the remotely deflecting step is carried out by directly deflecting the distal end of the electrode array catheter.

25. The procedure of claim 20 wherein the chosen procedure includes the step of mapping the endocardial wall at the target site.

26. The procedure of claim 20 wherein the chosen procedure includes the step of ablation of a portion of the endocardial wall at the target site.

27. The procedure of claim 26 wherein the ablation step is carried out using at least one pair of ablation electrodes.

28. An electrode array catheter, for insertion into a heart chamber for placement of multiple electrodes against the heart chamber wall in the vicinity of a target site, comprising:

an electrode assembly including a distal end, said distal end comprising;

an elongate electrode body which naturally assumes a distally-extending, three-dimensional, coiled, generally conical shape when in an unconstrained, deployed position; and

at least four electrodes mounted to the electrode body and positioned over more than about 360°

of electrode body, said electrodes being electrically isolated from one another and naturally assuming a distally-extending, three-dimensional, coiled, generally conical array when said distal end is unconstrained, said electrodes distributed along said distal end to be able to contact a portion of the chamber wall surrounding the target site, said portion being substantially less than the entire chamber wall.

29. The catheter according to claim 28 further comprising a flexible delivery sheath having a hollow interior, a proximal end and a distal end, the electrode assembly slidably mounted within the hollow interior of the delivery sheath for movement between a retracted position, at least substantially housed within the hollow interior, and a deployed position, extending from the distal end of the delivery sheath.

30. An electrode array catheter, for insertion into a heart chamber for placement of multiple electrodes against the heart chamber wall in the vicinity of a target site, comprising:

an electrode assembly including;

a distal end having a single elongate, resilient, conformable electrode body; and

a plurality of electrodes distributed along the electrode body so that said electrodes naturally assume an array when said electrode body is unconstrained, said electrodes being distributed along the electrode body so as to be able to contact a limited portion of the chamber wall surrounding the target site;

a flexible delivery sheath, having a hollow interior, a proximal end and a distal end, the electrode assembly being slidably mounted within the hollow interior of the delivery sheath for movement between a retracted position, at least substantially housed within the hollow interior, and a deployed position, extending from the distal end of the delivery sheath; and

the sheath having a distal tip which acts as an electrode.

31. The catheter of claim 30 wherein the electrode body naturally assumes a two-dimensional shape when unconstrained.

32. The catheter of claim 31 wherein the two-dimensional shape is a serpentine shape.

33. The catheter of claim 31 wherein the two-dimensional shape is a flat coil.

34. The catheter of claim 30 wherein the electrode body naturally assumes a three-dimensional, coiled, conical shape when in the deployed position.

35. The catheter of claim 34 wherein the coiled, conical shape is a diverging coiled, conical shape.

36. The catheter of claim 30 wherein the electrodes include a plurality of mapping/pacing electrodes and at least one ablation electrode.

37. The catheter of claim 30 wherein the electrode assembly includes a temperature-sensing ablation electrode.