Biplanar deflectable catheter for arrhythmogenic tissue ablation

• US 5,327,905 A
• Filed: 12/11/1992
• Issued: 07/12/1994
• Est. Priority Date: 02/14/1992
• Status: Expired due to Term

• Current Assignee: Boaz Avitall
• Original Assignee: Boaz Avitall
• Inventors: Avitall, Boaz
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US07/989,804
• Time in Patent Office: 578 Days
• Field of Search: 128/656, 128/657, 128/658, 128/772, 128/639, 128/642, 128/784, 128/785, 128/786, 128/790, 606/45, 606/46, 606/47, 606/48, 606/49, 604/53, 604/280, 604/281, 604/282, 607/115, 607/119, 607/122, 607/72
• US Class Current: 600/585
• 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 2017/2923 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2018/00946 slidable
• CPC Class Codes: A61B 2018/00952 rotatable
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/06 for high-frequency therapy

Abstract

A vascular catheter has a highly flexible distal section. A biplanar control system is provided for enabling and controlling the movement of the distal catheter section and tip in any direction in a manner such that the distal tip is capable of accessing any point on the wall of the chamber entered. Dual-wire biplanar control system embodiments include a vertical deflection control wire operable to deflect the distal tip of the catheter in a controlled manner in a vertical plane substantially parallel to the longitudinal axis of the tubular catheter and a lateral deflection control wire operable to deflect the distal tip of the catheter in a controlled manner in a lateral plane substantially perpendicular to the longitudinal axis of the tubular catheter. A one-wire system for both vertical and lateral control is also described.

Claims

1. A catheter comprising:

(a) a flexible, tubular distal catheter section extending a main catheter tube and describing a distal catheter lumen and having a working distal tip area to be precisely controlled and including a distal tip;

(b) a single multi-function manipulation control means for manipulative control of the distal tip area and having a distal end anchored at or near the distal tip of the distal catheter section and operable in a manner such that the application of controlled longitudinal tension to the multi-function manipulation control means produces a corresponding controlled longitudinal bending of the distal tip area and the controlled application of rotational torque to the multi-function deflection control means produces a corresponding controlled radial deflection of the distal tip area in a plane substantially parallel to a direction of the applied rotational torque; and

(c) wherein the combined application of longitudinal tension and rotational torque to the control element provides three-dimensional manipulative control of the working distal tip section.

2. The apparatus of claim 1 further comprising a tail segment attached to or as a continuation of the distal tip of the distal catheter section to aid in positioning and stabilizing the distal tip area.

3. The apparatus of claim 1 wherein the manipulation control means is a tension and torque transmitting control wire, said apparatus further comprising torque control means comprising:

a self-locking, hand-rotatable knob for applying controlled rotational torque to said control wire.

4. The apparatus of claim 3 wherein said manipulation control means comprises a hand-operable reciprocating piston means for applying controlled longitudinal tension to said control wire.

5. The apparatus of claim 2 wherein at least a portion of the distal catheter section is predisposed to assume a predetermined non-linear shape, such that the shape is resumed upon deployment of the distal section.

6. The apparatus of claim 5 wherein the working distal tip area of the distal catheter section further comprises a plurality of spaced electrodes suitable for both mapping and ablation.

7. The apparatus of claim 1 wherein the working distal tip area of the distal catheter section further comprises a plurality of spaced electrodes suitable for both mapping and ablation.

8. The apparatus of claim 1 wherein the manipulation control means is characterized by having greater flexibility in a portion traversing the distal catheter lumen.

9. The apparatus of claim 1 further comprising system control means for applying said longitudinal tension and rotational torque to the multi-function manipulation control means.

10. The apparatus of claim 1 wherein the manipulation control means is a control wire and wherein the manipulation control means is threaded through the distal catheter lumen.

11. The apparatus of claim 10 further comprising a main catheter tube describing a lumen and wherein the manipulation control means is threaded through the main catheter tube.

12. The apparatus of claim 1 wherein at least a portion of the distal catheter section is predisposed to assume a predetermined non-linear shape, such that the shape is resumed upon deployment of the distal catheter section.

13. The apparatus of claim 12 wherein the working distal tip area of the distal catheter section further comprises a plurality of spaced electrodes suitable for both mapping and ablation.

14. A single element manipulation control system for a catheter comprising:

(a) a main catheter tube describing a lumen therein;

(b) a flexible, tubular distal catheter section extending the main catheter tube, having an external surface and describing a distal catheter lumen and having a working distal tip area to be precisely controlled and including a distal tip;

(c) electrode means for establishing electrical connection with adjacent tissue surfaces comprising at least one electrode carried by the working distal tip area in communication with the external surface of the distal catheter section;

(d) a control system for controlling said working distal tip area comprising an independent multi-function manipulation control element threaded loosely within the main catheter tube and the distal catheter lumen and having a distal end anchored at or near the distal tip of the distal catheter section and operable in a manner such that the application of tension to the control element axially displaces the control element and produces a corresponding controlled axial deflection or bending of the distal tip and the application of rotational torque to the control element produces a corresponding controlled radial deflection of the distal tip in a plane substantially parallel to a direction of the applied rotational torque;

(e) wherein the application of a combination of axial tension and rotational torque to the control element provides three-dimensional manipulative control of the working distal tip section; and

(f) control means for applying said axial tension and rotational torque to the multi-function manipulation control element comprising;

(1) a control handle means for manipulating the distal tip area containing a cylindrical recess, a reciprocal piston means for operating the control means with the control handle means disposed in and reciprocally operable in the cylindrical recess and attached to the control means such that reciprocal motion of the piston causes a corresponding axial displacement of the multi-function manipulation control element and thereby controls the axial deflection of the distal tip; and

(2) wherein the piston means is retained in hand-rotatable relation to the handle means such that the rotation of the piston means with respect to the handle means applies said rotational torque to the multi-function manipulation control element which the control element transmits to the distal tip thereby causing the distal tip to deflect radially correspondingly as desired.

15. The apparatus of claim 14 wherein at least a portion of the distal catheter section is predisposed to assume a predetermined non-linear shape, such that the shape is resumed upon deployment of the distal section.

16. The apparatus of claim 15 further comprising a tail segment attached to or as a continuation of the distal tip of the distal catheter section to aid in positioning and stabilizing the electrode means.

17. The apparatus of claim 14 wherein the electrode means further comprises a plurality of spaced electrodes suitable for both mapping and ablation.

18. The apparatus of claim 14 further comprising means for providing and adjusting an initial longitudinal tension in the control means.

19. The apparatus of claim 14 wherein the piston means further comprises an external, hand-operable piston handle means for controlling the movement of the piston means.

20. The apparatus of claim 19 further comprising locking means for preventing the unwanted relative movement of the piston means.

21. The apparatus of claim 20 wherein the piston locking means further comprises at least one series including a plurality of longitudinally spaced, aligned retention ridges subtending a minor arc on a surface of the piston means and a laterally mounted retention means for limiting travel of the piston means fixed to the control means handle and extending across a segment of the cylindrical recess, the piston means further having a corresponding flat sector rotated from the retention ridges, cooperation being such that the piston means is freely reciprocally adjustable in the cylindrical recess when rotated so that the flat sector addresses the lateral retention means and is retained in position when rotated so that a retention ridge addresses the lateral retention means.

22. The apparatus of claim 21 further comprising a pair of oppositely disposed series of retention ridges separated by a pair of oppositely disposed flat sectors and wherein said laterally mounted retention means includes a pair of oppositely disposed laterally mounted retention means.

23. The apparatus of claim 14 further comprising relative rotation limiting means associated with and limiting the relative rotation of the handle and the piston means.

24. The apparatus of claim 23 wherein the rotating limiting means includes:

(a) a threaded rider means for limiting travel along and adapted to ride between predetermined extremes on a threaded shaft for carrying the threaded rider means fixed to the distal end of the piston means and including rotation preventing means preventing the rider means from rotating with the threaded shaft such that rotation of the threaded shaft causes relative displacement of the threaded rider means therealong; and

(b) stop means limiting the travel of the rider means such that relative rotation between the rider means and the threaded shaft means and so torque applied to the control means is limited in either direction.

25. The apparatus of claim 24 wherein the rotation preventing means includes at least one lateral projection means for preventing rotation and wherein the cylindrical recess is provided with one or more longitudinal grooves for receiving the projection means and in which it rides.

26. A method of mapping the electrical cardiac depolarization potentials and ablating tissue comprising the steps of:

(a) introducing a deflectable cardiac mapping and ablation catheter system into a vascular system of a patient, the catheter system comprising;

(1) a catheter having a flexible, tubular distal catheter section describing a distal catheter lumen and having a distal tip sought to be precisely controlled;

(2) a single element control means for axial and radial deflection control disposed and extending within the distal catheter lumen and having a distal end anchored at a point at or near the distal end of the flexible distal catheter section and operable in a manner such that the reciprocal movement of the control means deflects or bends the distal tip of the catheter in a plane substantially parallel a direction of movement of the control means and such that the application of rotational torque to the control means when the tip is bent produces a corresponding deflection of the distal tip of the catheter in a radial plane substantially parallel to the direction of the applied rotational torque;

(3) means for reciprocally displacing the single element control means along the flexible distal catheter lumen; and

(4) means for applying rotational torque to the single element control means;

(5) tip electrode means comprising at least one electrode carried by an electrode segment of the distal catheter section connected through the catheter system and in communication with an external surface of the distal catheter section;

(b) adjusting the combined tension and torsion in the single element control means to deflect and steer the electrode means to access the tissue surface of the chamber as required;

(c) using the tip electrode means to detect and map cardiac depolarization potentials; and

(d) operating said tip electrode means to ablate early activation sites as indicated.

27. The method of claim 26 further comprising the steps of:

(d) using a distal tip segment of the flexible tubular distal catheter section configured in a predetermined non-linear shape to more closely match the shape of a surface of a designated cardiac area; and

(e) maneuvering the predetermined non-linear shape to match and map and/or ablate the tissue surface of said specifically designated cardiac area.

28. A system for controlling manipulation of a catheter tip area in three-dimensional space comprising:

(a) a catheter device having a proximal and a distal end an axis and a distal catheter tip area to be controlled at or proximate the distal end thereof;

(b) independent manipulation means associated with said catheter device, the manipulation means further comprising a control element for the controlled bending of said catheter tip area, in a plane substantially parallel to the axis thereof, responsive to the application or relaxation of axial tension, and for the controlled radial manipulation of the catheter tip area, by the application of rotational torque, such that a combined application of axial tension and rotational torque to the control element produces three-dimensional manipulative control of the catheter tip; and

(c) control means associated with said manipulation means for applying or relaxing axial tension and rotational torque thereto.

29. The apparatus of claim 28 wherein the manipulation means comprises a single wire element.

30. The apparatus of claim 29 wherein the catheter device further comprises a catheter tube having a wall and describing a lumen therein and wherein said single wire element is threaded along said catheter tube and loosely contained within the catheter lumen and attached to the tube wall in the catheter tip area.

31. A dual-element catheter tip control system comprising:

(a) a catheter having a highly flexible, tubular distal catheter section having a distal end and describing a distal catheter lumen and having a distal tip sought to be precisely controlled;

(b) a first deflection control element threaded within the distal catheter lumen and having a distal end anchored at a point at or near the distal end of the flexible distal catheter section in a manner such that the axial displacement thereof deflects the distal tip of the catheter axially in a plane substantially parallel a direction of element movement;

(c) means for axially displacing the first deflection control element further comprising;

(1) a hand-operated control handle having an axially displaceable section attached to the first deflection control element, the axial motion of which causes a corresponding axial displacement of the first deflection control element and thereby controls the axial deflection of the distal tip;

(d) a second deflection control element threaded within the distal catheter lumen and having a distal end anchored at or near the distal end of the flexible distal catheter section in a manner such that the application of rotational torque to the second deflection control element produces a corresponding radial deflection of the distal tip of the catheter in a plane substantially parallel to the direction of the applied rotational torque; and

(e) means for applying said rotational torque to the second deflection control element further comprising;

(1) a self-locking, hand-rotatable radial adjustment control knob mounted from the control handle and attached to the second deflection control element in a manner such that rotation of the knob left or right applies a corresponding rotational torque to the second deflection control element which transmits it to the distal tip thereby causing the distal tip to deflect radially as desired.

32. A dual-element catheter tip control system comprising:

(a) a catheter having a highly flexible, tubular distal catheter section having a distal end and describing a distal catheter lumen and having a distal tip sought to be precisely controlled;

(b) a first deflection control element threaded within the distal catheter lumen and having a distal end anchored at a point at or near the distal end of the flexible distal catheter section in a manner such that the movement of the first deflection control element axially along in the distal catheter lumen deflects the distal tip of the catheter in a plane substantially parallel a direction of element movement;

(c) means for axially displacing the first deflection control element along the flexible distal catheter lumen comprising;

(1) a hand-operated control handle having a longitudinally displaceable section attached to the first deflection control element, the longitudinal motion of which causes a corresponding longitudinal displacement of the first deflection control element and thereby controls the axial deflection of the distal tip;

(d) a second deflection control element threaded within the distal catheter lumen and having a distal end anchored at or near the distal end of the flexible distal catheter section in a manner such that the application of rotational torque to the second deflection control element produces a corresponding radial deflection of the distal tip of the catheter in a plane substantially parallel to the direction of the applied rotational torque; and

(e) means for applying said rotational torque to the second deflection control element further comprising;

(1) a rotatable ring gear means associated with an internal pinion gear connected to the second deflection control wire in a manner such that rotation of the ring gear causes a corresponding opposite rotation of the pinion gear, rotation of the pinion gear applying a corresponding amount of rotational torque to the second deflection control element which, in turn, transmits the torque to the distal tip and translating the torque into control to cause the distal tip to deflect radially as desired.