Multicurve deflectable catheter

• US 5,487,757 A
• Filed: 02/21/1995
• Issued: 01/30/1996
• Est. Priority Date: 07/20/1993
• Status: Expired due to Term

• Current Assignee: Medtronic Cardiorhythm
• Original Assignee: Medtronic Cardiorhythm
• Inventors: Truckai, Csaba, Nguyen, Frank, West, Scott H., Jaraczewski, Richard S.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): VANOVER, PERRY
• Application Number:
  US08/391,333
• Time in Patent Office: 343 Days
• Field of Search: 607/122, 607/123, 607/116, 607/119, 604/95, 604/264, 604/265, 604/280, 606/33, 606/41, 606/46, 606/48, 606/49, 606/50, 128/642, 128/668, 128/670, 128/695
• US Class Current: 604/264
• 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 2017/003 Steerable
• CPC Class Codes: A61B 2018/00065 porous
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/0091 Handpieces of the surgical instrument or device
• CPC Class Codes: A61B 2018/00946 slidable
• CPC Class Codes: A61B 2018/00952 rotatable
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0141 having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0144 having flexible regions as a result of inner reinforcement means, e.g. struts or rods
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61N 1/056 : Transvascular endocardial electrode systems

Abstract

An electrophysiology catheter (20) comprises a shaft (22) having a first bending stiffness and a deflectable tip (28) secured to the distal end (24) of the shaft with a second bending stiffness less than the first bending stiffness. At least one electrode (34, 36) is mounted to the tip for delivering current to or monitoring electrical activity of tissue. A manipulator wire (58) is coupled to the distal end of the deflectable tip, whereby the deflectable tip may be deflected by axial force applied to the manipulator wire. A stiffener member (66) is axially slidable relative to the tip so as to adjust the tip curvature without removing the catheter from the body. The catheter may further include a core wire (72) configured to rotate the deflectable tip about a longitudinal axis (2) without rotating the proximal end (26) of the catheter shaft, wherein the distal end of the deflectable tip remains in a substantially constant axial position, preferably in a plane perpendicular to the longitudinal axis.

Claims

1. A steerable electrophysiology catheter comprising:

a shaft with a first bending stiffness, the shaft having a proximal end, a distal end, and an axial lumen therebetween;

a deflectable tip with a second bending stiffness less than the first bending stiffness, the deflectable tip having a proximal end secured to the distal end of the shaft, a distal end and an axial tip lumen in communication with the axial lumen of the shaft;

at least one electrode secured to the deflectable tip;

means for conducting current between the proximal end of the shaft and the electrode;

a manipulator wire extending through the axial lumen of the shaft and the tip lumen, the manipulator wire having a distal end secured to the distal end of the deflectable tip and a proximal end near the proximal end of the shaft;

an elongate, flexible stiffener element slidably disposed in the axial lumen of the shaft and the tip lumen, the stiffener element having a third bending stiffness;

means at the proximal end of the shaft for applying axial force to the manipulator wire to deflect the deflectable tip into a first curvature; and

means at the proximal end of the shaft for axially moving the stiffener element relative to the deflectable tip such that at least a portion of the deflectable tip assumes a second curvature.

2. The catheter of claim 1 wherein the shaft further includes means embedded in a wall thereof for reinforcing the shaft.

3. The catheter of claim 2 wherein the reinforcing means comprises a wire mesh.

4. The catheter of claim 1 wherein the stiffener element is a stiffener wire.

5. The catheter of claim 1 further comprising means for rotating the deflectable tip about a longitudinal axis without rotating the proximal end of the shaft.

6. The catheter of claim 1 further comprising:

a core wire disposed in the axial lumen of the shaft and the tip lumen, the core wire having a distal end rotatably driveably coupled to the deflectable tip and a proximal end near the proximal end of the shaft; and

means for exerting torque on the proximal end of the core wire so to rotate the deflectable tip about a longitudinal axis without rotating the proximal end of the shaft.

7. The catheter of claim 6 wherein the proximal end of the tip is secured to the core wire so to transmit torque from the core wire to the tip at the proximal end of the tip.

8. The catheter of claim 6 wherein the axial tip lumen of the deflectable tip comprising a first, radially offset, axial tip lumen housing the manipulator wire, a second axial tip lumen housing the stiffener element, and a third axial tip lumen, the core wire being disposed in the third axial tip lumen.

9. The catheter of claim 8 wherein the core wire has a distal portion having a cross-sectional width and thickness, the width being substantially greater than the thickness.

10. The catheter of claim 9 wherein the distal portion of the core wire has first and second sections with first and second cross-sectional widths and thicknesses.

11. The catheter of claim 9 wherein the third axial lumen has a cross-sectional width and height, the width being substantially greater than the height.

12. The catheter of claim 1 wherein the shaft includes an outer surface layer having a Durometer reading in the range of 35 D to 75 D.

13. The catheter of claim 1 wherein the deflectable tip includes an outer surface layer having a Durometer reading in the range of 30 D to 55D.

14. The catheter of claim 1 wherein the deflectable tip is deflectable about an angle of at least about 360°

relative to the shaft.

15. The catheter of claim 1 further comprising a handle secured to the proximal end of the shaft, wherein the means for moving the stiffener wire and the means for applying force to the manipulator wire are coupled to the handle.

16. The catheter of claim 15 wherein the means for moving the stiffener wire comprises a first slide axially slidable on the handle and secured to the proximal end of the stiffener wire.

17. The catheter of claim 15 wherein the means for applying force to the manipulator wire comprises a slide axially slidable on the handle and secured to the proximal end of the manipulator wire.

18. The catheter of claim 17 further comprising means in the handle for adjustably applying friction to the slide so as to hold the manipulator wire in tension.

19. The catheter of claim 15 wherein the handle comprises at least two detachable sections, a first detachable section including the means for moving the stiffener wire and a second detachable section including the means for applying force to the manipulator wire.

20. The catheter of claim 19 wherein the handle further comprises a third detachable section including means for rotating the deflectable tip about a longitudinal axis without rotating the proximal end of the shaft.

21. The catheter of claim 19 wherein the first and second detachable sections comprise universal means for connecting the detachable sections to each other.

22. The catheter of claim 21 wherein the universal connecting means comprises a snap fit coupling.

23. A method of electrophysiological treatment comprising:

introducing a catheter through a vessel so that a distal end of the catheter is positioned in the heart, the catheter having a shaft with a first bending stiffness;

applying axial force to a manipulator wire coupled to a deflectable tip secured to a distal end of the shaft to deflect the deflectable tip in a first curvature, the deflectable tip having a second bending stiffness less than the first bending stiffness;

axially translating a stiffener wire slidably disposed in an axial lumen of the deflectable tip such that the deflectable tip assumes a second curvature; and

electrically operating at least a first electrode on the deflectable tip associated with a target site on a wall of the heart.

24. The method of claim 23 wherein the electrically operating step is carried out by applying a current through at least the first electrode.

25. The method of claim 23 wherein the stiffener wire is translated to a position coextensive with only a proximal portion of the deflectable tip, whereby the proximal portion of the deflectable tip assumes a curvature which is different than a distal portion of the deflectable tip.

26. The method of claim 23 wherein the deflectable tip is deflected through an angle of at least 90°

relative to the shaft.

27. The method of claim 23 further comprising rotating the deflectable tip about a longitudinal axis parallel to the shaft without rotating a proximal end of the shaft.

28. The method of claim 27 wherein the deflectable tip is rotated such that a distal end of the tip remains generally within a plane perpendicular to the shaft.

29. A steerable electrophysiology catheter comprising:

a shaft with a first bending stiffness, the shaft having a proximal end, a distal end, and an axial lumen therebetween;

a deflectable tip with a second bending stiffness less than the first bending stiffness, the deflectable tip having a proximal end secured to the distal end of the shaft, a distal end, a first radially offset axial tip lumen, a second axial tip lumen and a third axial tip lumen, each of said first, second and third axial tip lumens being in communication with the axial lumen of the shaft;

at least one electrode secured to the deflectable tip;

means for delivering current from the proximal end of the shaft to the electrode;

a manipulator wire extending through the axial lumen of the shaft and the first axial tip lumen, the manipulator wire having a distal end secured to the distal end of the deflectable tip and a proximal end near the proximal end of the shaft;

means at the proximal end of the shaft for applying axial force to the manipulator wire to deflect the deflectable tip into a first curvature;

a core wire disposed in the axial lumen of the shaft and the second axial tip lumen, the core wire having a distal end secured to the distal end of the deflectable tip and a proximal end near the proximal end of the shaft;

means for exerting torque on the proximal end of the core wire so to rotate the deflectable tip about a longitudinal axis without rotating the proximal end of the shaft;

a stiffener wire slidably disposed in the axial lumen of the shaft and the third axial tip lumen; and

means at the proximal end of the shaft for axially moving the stiffener wire relative to the deflectable tip such that at least a portion of the deflectable tip assumes a second curvature.

30. The catheter of claim 29 wherein the core wire has a distal portion having a cross-sectional width and thickness, the width being substantially greater than the thickness.

31. The catheter of claim 29 wherein the second axial lumen has a cross-sectional width and height, the width being substantially greater than the height so as to prevent rotation of the distal portion of the core wire relative to the distal tip.

32. The catheter of claim 29 wherein the proximal end of the tip is secured to the core wire so to transmit torque from the core wire to the tip at the proximal end of the tip.

33. The catheter of claim 32 wherein the distal portion of the core wire has first and second sections with first and second cross-sectional widths and thicknesses.

34. A steerable electrophysiology catheter comprising:

a handle;

a shaft with a first bending stiffness, the shaft having a proximal end secured to the handle, a distal end, and an axial lumen therebetween;

a deflectable tip with a second bending stiffness less than the first bending stiffness, the deflectable tip having a proximal end secured to the distal end of the shaft, a distal end and an axial tip lumen in communication with the axial lumen of the shaft;

at least one electrode secured to the deflectable tip;

means for conducting current between the proximal end of the shaft and the electrode;

a manipulator wire extending through the axial lumen of the shaft and the tip lumen, the manipulator wire having a distal end secured to the distal end of the deflectable tip and a proximal end near the proximal end of the shaft;

an elongate, flexible stiffener element slidably disposed in the axial lumen of the shaft and the tip lumen, the stiffener element having a proximal end and a third bending stiffness;

means, coupled to the handle, for applying axial force to the manipulator wire to deflect the deflectable tip into a first curvature;

means, including a first slide axially slidable on the handle and secured to the proximal end of the stiffener wire, for axially moving the stiffener element relative to the deflectable tip such that at least a portion of the deflectable tip assumes a second curvature;

the handle including an outer surface, opposite which the first slide is positioned, and an inner surface; and

the stiffener element moving means including a ball and slider element secured to the first slide and positioned against the inner surface of the handle, the ball slider element having at least one low friction element in contact with the inner surface of the handle.

35. The catheter of claim 34 wherein the low friction elements are metal spherical elements.