Bidirectional steerable cathether with bidirectional control handle

• US 6,183,463 B1
• Filed: 08/28/1998
• Issued: 02/06/2001
• Est. Priority Date: 12/01/1997
• Status: Expired due to Term

• Current Assignee: Cordis Webster, Inc.
• Original Assignee: Cordis Webster, Inc.
• Inventors: Webster, Wilton W. Jr.
• Primary Examiner(s): THOMPSON, MICHAEL M
• Assistant Examiner(s): THOMPSON, MICHAEL M
• Application Number:
  US09/143,426
• Time in Patent Office: 893 Days
• Field of Search: 604/95, 604/264, 604/194, 604/114, 604/22, 604/19, 604/528-9
• US Class Current: 604/528
• 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 2018/00029 open
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• 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 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A bidirectional steerable catheter comprises a catheter body, a tip section and a control handle. The catheter body has a tubular wall, proximal and distal ends, and at least one lumen extending therethrough. The tip section comprises flexible tubing having proximal and distal ends and at least one lumen extending therethrough. The proximal end of the tip section is fixedly attached to the distal end of the catheter body. The control handle is mounted at its distal end to the proximal end of the catheter body. The control handle comprises a housing having proximal and distal ends. A distal piston is mounted in the distal end of the housing and fixedly attached to the proximal end of the catheter body. The distal piston is slidably movable relative to the housing. First and second proximal pistons are mounted in the housing proximal to the distal piston. Each of the proximal pistons is slidably movable relative between proximal and distal positions to the housing. The control handle further comprises a movable member capable of selectively and releasably engaging one of the proximal pistons to prevent slidable movement of that engaged proximal piston relative to the housing while allowing slidable movement of the other non-engaged proximal piston relative to the housing so that proximal movement of the housing relative to the distal piston and catheter body results in proximal movement of the engaged proximal piston relative to the distal piston and catheter body. The catheter further comprises a pair of puller wires having proximal and distal ends. Each puller wire extends from the control handle, through a lumen in the catheter body and into an off axis lumen in the tip section. The distal end of each puller wire is fixedly attached to the tip section, and the proximal end of each puller wire is anchored to a separate associated proximal piston in the control handle. In practice, proximal movement of the selectively engaged proximal piston and its associated puller wire relative to the catheter body results in deflection of the tip section in the direction of the off axis lumen into which that associated puller wire extends.

Claims

1. A bidirectional steerable catheter comprising:

a catheter body having a tubular wall, proximal and distal ends, and at least one lumen extending therethrough;

a tip section comprising flexible tubing having proximal and distal ends and at least one lumen extending therethrough, the proximal end of the tip section being fixedly attached to the distal end of the catheter body;

a control handle mounted at its distal end to the proximal end of the catheter body comprising;

a housing having proximal and distal ends;

a distal piston mounted in the distal end of the housing and fixedly attached to the proximal end of the catheter body, said distal piston being slidably movable relative to the housing;

first and second proximal pistons mounted in the housing proximal to the distal piston, each of said proximal pistons being slidably movable between proximal and distal positions relative to the housing;

a movable member capable of selectively and releasably engaging one of the proximal pistons to prevent slidable movement of that engaged proximal piston relative to the housing while allowing slidable movement of the other non-engaged proximal piston relative to the housing so that proximal movement of the housing relative to the distal piston and catheter body results in proximal movement of the engaged proximal piston relative to the distal piston and catheter body; and

a pair of puller wires having proximal and distal ends, each puller wire extending from the control handle, through a lumen in the catheter body and into an off axis lumen in the tip section, the distal end of each puller wire being fixedly attached to the tip section and the proximal end of each puller wire being anchored to a separate associated proximal piston in the control handle,

wherein proximal movement of the selectively engaged proximal piston and its associated puller wire relative to the catheter body results in deflection of the tip section in the direction of the off axis lumen into which that associated puller wire extends.

2. A catheter according to claim 1, wherein the distal end of the distal piston extends outside the handle housing and the distal piston comprises a thumb rest mounted near its distal end.

3. A catheter according to claim 1, wherein the member is manually moveable and extends transversely through the handle housing and is moveable transversely between first and second positions, wherein, in its first position, the member engages the first proximal piston in its proximal position to prevent distal movement of that first proximal piston relative to the housing without preventing longitudinal movement of the second proximal piston relative to the housing and, in its second position, the member engages the second proximal piston in its proximal position to prevent distal movement of that second proximal piston relative to the housing without preventing longitudinal movement of the first proximal piston relative to the housing.

4. A catheter according to claim 3, wherein:

each proximal piston has a select diameter along its length and comprises a circumferential notch section along its length having a reduced diameter less than the selected diameter, and

the member comprises a generally dumbbell-shaped slot having a generally rectangular center section having a width greater than the reduced diameter of the circumferential notch section and less than the select diameter of the proximal pistons, and further comprising first and second generally circular sections at the ends of the center section, the diameter of each circular section being greater than the select diameter of the proximal pistons,

wherein, when the member is in its first position, the center section of the slot engages the circumferential notch section of the first proximal piston, preventing longitudinal movement of the first proximal piston relative to the handle housing and the first of the generally circular sections is positioned to allow longitudinal movement of the second proximal piston therethrough; and

when the moveable member is in its second position, the center section of the slot engages the circumferential notch section of the second proximal piston, preventing longitudinal movement of the second proximal piston relative to the handle housing, and the second of the generally circular sections is positioned to allow longitudinal movement of the first proximal piston therethrough.

5. A catheter according to claim 1, wherein the movable member comprises a longitudinally fixed rotatable sleeve in surrounding relation to the distal piston, said sleeve extending proximally to a position adjacent the distal ends of the proximal pistons when the proximal pistons are in their proximal positions, said sleeve comprising a slot at its proximal end, said slot having a width larger than the diameter of each proximal piston,

wherein the sleeve is rotatable between a first position where the slot is aligned with the first proximal piston, thereby allowing distal movement of the first proximal piston while preventing distal movement of the second proximal piston;

and a second position where the slot is aligned with the second proximal piston, thereby allowing distal movement of the second proximal piston while preventing distal movement of the first proximal piston.

6. A catheter according to claim 1, wherein the distal piston contains an axial hole extending along its length to permit the puller wires to extend therethrough.

7. A catheter according to claim 1, wherein the proximal pistons are mounted in opposite quadrants of the housing.

8. A bidirectional steerable catheter comprising:

a catheter body having a tubular wall, proximal and distal ends, and at least one lumen extending therethrough;

a tip section comprising flexible tubing having proximal and distal ends and at least one lumen extending therethrough, the proximal end of the tip section being fixedly attached to the distal end of the catheter body;

a control handle mounted at its distal end to the proximal end of the catheter body comprising;

a housing having proximal and distal ends;

a distal piston mounted in the distal end of the housing and fixedly attached to the proximal end of the catheter body, said distal piston being slidably movable relative to the housing and containing an axial hole extending along its length;

first and second proximal pistons mounted in the housing proximal to the distal piston, each of said proximal pistons being slidably movable between proximal and distal positions relative to the housing;

a member for selectively preventing simultaneous longitudinal movement of the proximal pistons relative to the housing, said member being moveable between a first position, wherein the first proximal piston is releasably fixed in its proximal position relative to the handle housing and the second proximal piston is permitted slidable movement relative to the handle housing, and a second position, wherein the second proximal piston is releasably fixed in its proximal position relative to the handle housing and the first proximal piston is permitted slidable movement relative to the handle housing; and

a pair of puller wires having proximal and distal ends, each puller wire extending from the control handle, through a lumen in the catheter body and into an off axis lumen in the tip section, the distal end of each puller wire being fixedly attached to the tip section and the proximal end of each puller wire being anchored to a separate associated proximal piston in the control handle,

wherein proximal movement of the housing relative to the distal piston and catheter body results in proximal movement of one proximal piston and its associated puller wire relative to the catheter body, which in turn results in deflection of the tip section in the direction of the off axis lumen into which that associated puller wire extends.

9. A catheter according to claim 8, wherein the member is manually moveable and extends transversely through the handle housing and is moveable transversely between first and second positions, wherein, in its first position, the member engages the first proximal piston in its proximal position to prevent distal movement of that first proximal piston relative to the housing without preventing longitudinal movement of the second proximal piston relative to the housing and, in its second position, the member engages the second proximal piston in its proximal position to prevent distal movement of that second proximal piston relative to the housing without preventing longitudinal movement of the first proximal piston relative to the housing.

10. A catheter according to claim 9, wherein:

each proximal piston has a select diameter along its length and comprises a circumferential notch section along its length having a reduced diameter less than the selected diameter, and

the member comprises a generally dumbbell-shaped slot having a generally rectangular center section having a width greater than the reduced diameter of the circumferential notch section and less than the select diameter of the proximal pistons, and further comprising first and second generally circular sections at the ends of the center section, the diameter of each circular section being greater than the select diameter of the proximal pistons,

wherein, when the member is in its first position, the center section of the slot engages the circumferential notch section of the first proximal piston, preventing longitudinal movement of the first proximal piston relative to the handle housing and the first of the generally circular sections is positioned to allow longitudinal movement of the second proximal piston therethrough; and

when the moveable member is in its second position, the center section of the slot engages the circumferential notch section of the second proximal piston, preventing longitudinal movement of the second proximal piston relative to the handle housing, and the second of the generally circular sections is positioned to allow longitudinal movement of the first proximal piston therethrough.

11. A catheter according to claim 9, wherein the movable member comprises a longitudinally fixed rotatable sleeve in surrounding relation to the distal piston, said sleeve extending proximally to a position adjacent the distal ends of the proximal pistons when the proximal pistons are in their proximal positions, said sleeve comprising a slot at its proximal end, said slot having a width larger than the diameter of each proximal piston,

wherein the sleeve is rotatable between a first position where the slot is aligned with the first proximal piston, thereby allowing distal movement of the first proximal piston while preventing distal movement of the second proximal piston;

and a second position where the slot is aligned with the second proximal piston, thereby allowing distal movement of the second proximal piston while preventing distal movement of the first proximal piston.

12. A bidirectional steerable catheter comprising:

a catheter body having a tubular wall, proximal and distal ends, and at least one lumen extending therethrough;

a tip section comprising flexible tubing having proximal and distal ends and a pair of off-axis lumens extending therethrough, the proximal end of the tip section being fixedly attached to the distal end of the catheter body;

a control handle mounted at its distal end to the proximal end of the catheter body comprising;

a housing having proximal and distal ends;

a distal piston mounted in the distal end of the housing and fixedly attached to the proximal end of the catheter body, said distal piston being slidably movable relative to the housing;

first and second proximal pistons mounted in opposite quadrants of the housing proximal to the distal piston, each of said proximal pistons being slidably movable relative to the housing between proximal and distal positions, each having a select diameter along its length, and each comprising a circumferential notch section along its length having a reduced diameter less than the select diameter; and

a manually moveable member extending transversely through the handle housing and moveable transversely between first and second positions, the manually moveable member comprising a generally dumbbell-shaped slot having a generally rectangular center section having a width greater than the reduced diameter of the circumferential notch section and less than the select diameter of the proximal pistons, and further comprising first and second generally circular sections at ends of the center section, the diameter of each circular section being greater than the select diameter of the proximal pistons, wherein, when the member is in its first position, the center section of the slot engages the circumferential notch section of the first proximal piston, preventing longitudinal movement of the first proximal piston relative to the handle housing, and the first of the generally circular sections is positioned to allow longitudinal movement of the second proximal piston relative to the handle housing; and

when the moveable member is in its second position, the center section of the slot engages the circumferential notch section of the second proximal piston, preventing longitudinal movement of the second proximal piston relative to the handle housing, and the second of the generally circular sections is positioned to allow longitudinal movement of the first proximal piston relative to the handle housing; and

a pair of puller wires having proximal and distal ends, each puller wire extending through the axial hole of the distal piston in the control handle, through a lumen in the catheter body and into an off axis lumen in the tip section, the distal end of each puller wire being fixedly attached to the tip section and the proximal end of each puller wire being anchored to a separate associated proximal piston in the control handle,

wherein proximal movement of the housing relative to the distal piston and catheter body results in proximal movement of one proximal piston and its associated puller wire relative to the catheter body, which in turn results in deflection of the tip section in the direction of the off axis lumen into which that associated puller wire extends.

13. A bidirectional steerable catheter comprising:

a catheter body having a tubular wall, proximal and distal ends, and at least one lumen extending therethrough;

a tip section comprising flexible tubing having proximal and distal ends and at least one lumen extending therethrough, the proximal end of the tip section being fixedly attached to the distal end of the catheter body;

a control handle mounted at its distal end to the proximal end of the catheter body comprising;

a housing having proximal and distal ends;

a distal piston mounted in the distal end of the housing and fixedly attached to the proximal end of the catheter body, said distal piston being slidably movable relative to the housing;

first and second proximal pistons mounted in opposite quadrants of the housing proximal to the distal piston, each of said proximal pistons being slidably movable between proximal and distal positions relative to the housing, each having a select diameter along its length, and each comprising a circumferential notch section along its length having a reduced diameter less than the select diameter; and

a manually moveable member comprising a sleeve in surrounding relation to the distal piston, said sleeve extending proximally to a position adjacent the distal ends of the proximal pistons when the proximal pistons are in their proximal positions, said sleeve comprising a slot at its proximal end, said slot having a width larger than the diameter of each proximal piston, wherein the sleeve is rotatable between a first position where the slot is aligned with the first proximal piston, thereby allowing distal movement of the first proximal piston while preventing distal movement of the second proximal piston; and

a second position where the slot is aligned with the second proximal piston, thereby allowing distal movement of the second proximal piston while preventing distal movement of the first proximal piston; and

a pair of puller wires having proximal and distal ends, each puller wire extending through the axial hole of the distal piston in the control handle, through a lumen in the catheter body and into an off axis lumen in the tip section, the distal end of each puller wire being fixedly attached to the tip section and the proximal end of each puller wire being anchored to a separate associated proximal piston in the control handle,

wherein, when the sleeve is positioned to receive the first proximal piston, distal movement of the distal piston results in distal movement of the catheter body relative to the handle body and second proximal piston, causing deflection of the tip section in the direction of the puller wire anchored to the second proximal piston, and when the cover is rotated to receive the second proximal piston, distal movement of the distal piston results in distal movement of the catheter body relative to the handle body and first proximal piston, causing deflection of the tip section in the direction of the puller wire anchored to the first proximal piston.