Remotely steered catheterization device

• US 5,415,633 A
• Filed: 07/28/1993
• Issued: 05/16/1995
• Est. Priority Date: 07/28/1993
• Status: Expired due to Fees

• Current Assignee: Active Control eXperts, Inc. (ASML Holding NV)
• Original Assignee: Active Control eXperts, Inc. (ASML Holding NV)
• Inventors: Fish, Richard D., Crawley, Edward E., Lazarus, Kenneth B.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): TSOSIE, BRYAN
• Application Number:
  US08/098,205
• Time in Patent Office: 657 Days
• Field of Search: 604/95, 604/281, 128/657, 128/772
• US Class Current: 604/95.05
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 2025/0915 having features for changing the stiffness
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0158 with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A remotely steerable guidewire, catheter or insertable active implement is disclosed. A steerable guidewire or a catheter for coronary and peripheral catheterizations is illustrated, using smart materials such as piezoelectrics for controlling its motions inside the body via control inputs applied from outside the body. A steerable portion of the device, which may be either an active flexible tip or an active region along the length of the implement, controls the shaft position or modifies its stiffness. In one embodiment, manipulation of electrical control inputs permits deflection of the steerable region through a range of motion about the axis of the implement in a single plane. In further embodiments, the tip may deflect in multiple planes about its longitudinal axis, or the catheter may be selectively stiffened to assume an arc shape or to firmly lodge the tip in position in a vessel.

Claims

1. A remotely steerable catheterization device, such device comprising

an elongated body having proximal and distal ends, and being axially incompressible for advancing within a patient'"'"'s body when pushed from the proximal end

a steering tip at the distal end,, said steering tip including a flexible shim and a piezoceramic strain element attached to the shim by high shear strength bonding, and

electrical conductor means extending in said body from the proximal end to the steering tip for conducting electricity thereto

wherein said strain element controllably deflects the steering tip in response to control signals applied thereto via said electrical conductor means to steer the tip past vessel branches from said proximal end.

2. A remotely steerable catheterization device according to claim 1, wherein said body is tubular.

3. A remotely steerable catheterization device according to claim 1, wherein said body is a guidewire.

4. A remotely steerable catheterization device according to claim 1, wherein said body is a guide catheter.

5. A remotely steerable catheterization device according to claim 1, wherein said body is a catheter having a lumen for effecting a diagnostic or treatment regimen at said tip via said lumen.

6. A remotely steerable catheterization device according to claim 1, wherein said strain element forms a piezoelectric bender.

7. A remotely steerable catheterization device according to claim 1, wherein said steering tip includes a lever arm that is displaced by actuating a piezoelectric element.

8. A remotely steerable catheterization device according to claim 1, wherein said strain element includes plural distinct strain actuators placed at axially-separated positions along said steering tip.

9. A remotely steerable catheterization device according to claim 8, wherein said plural distinct strain actuators include actuators of different sizes.

10. A remotely steerable catheterization device according to claim 8, wherein said strain element includes piezoelectric elements of a thickness to be fully actuated by a signal that is safe for cardiac applications.

11. A remotely steerable catheterization device according to claim 1, wherein said strain element has a stiffness approximating a stiffness of a cardiac catheterization guidewire.

12. A remotely steerable catheterization device according to claim 1, wherein said strain element forms a piezoelectric actuator extending over a substantial length of the tip for holding the tip in a stiff curve.

13. A remotely steerable catheterization device according to claim 1, further comprising a control handle operatively holding the elongated body for manipulation of the body by said control handle, and including first means for advancing the distal end by pushing said body.

14. A remotely steerable catheterization device according to claim 13, wherein said handle includes electrical means for applying electrical signals to said electrical conduction means.

15. An insertable catheterization device comprising

an elongated body having proximal and distal ends, for advancing within a patient'"'"'s body when pushed from the proximal end

a steering tip at the distal end

electrical conduction means extending in said body for conducting electricity from the proximal end, and

a piezoceramic strain element means mounted by a shear-free coupling to a flexible shim in said device so as to receive electrical actuation signals via said electrical conduction means and bend the steering tip for physically controlling said device from its proximal end as it moves through branching vessels.

16. An insertable catheterization device according to claim 15, wherein said strain element means includes means distributed along the body for stiffening the body to lodge it securely in position within a vessel.

17. An insertable catheterization device according to claim 15, wherein said strain element means includes means distributed at said steering tip for actively bending the tip.

18. An insertable catheterization device according to claim 15, wherein said strain element means is a crystal.

20. An insertable catheterization device according to claim 15, further comprising an insulating flexible sheath enclosing said piezoceramic strain element means.

21. An insertable catheterization device according to claim 20, further comprising an exterior protective coil about said sheath.

19. A device for insertion into the body of a patient, such device comprising

an elongated flexible body including a tip

piezoceramic strain elements extending along at least a portion of the body and bonded by high shear strength coupling to produce a bending actuator of at least said portion of the body

conductive means for delivering a signal to the piezoceramic strain elements, and

control means for selectively providing said signal to the conductive means to physically control the portion covered by the strain elements.

22. An insertable catheterization device according to claim 19, wherein the strain elements are bonded to a metal shim in said portion.

23. An insertable catheterization device according to claim 22, wherein the metal shim is a common electrode of said strain elements.

24. A steerable catheterization device comprising

a long thin and flexible body including a flexible tip

said body including an inextensible element at said tip and a piezoceramic strain element which is actuated by applying a voltage across opposite sides thereof, said strain element extending adjacent the inextensible element to steer the tip when the strain element is actuated,

electrical conductors extending along said body for conducting electricity to the strain element, and

for selectively providing a voltage to said strain element to actuate the strain element and steer the tip in a desired direction.

25. A steerable catheterization device according to claim 24, wherein the strain element is a piezoceramic plate having a thickness to be fully actuated by a potential under thirty volts.

26. A steerable catheterization device according to claim 24, wherein the inextensible element is selected from a set including a shim or a pivot element.