Steerable medical device

• US 4,998,916 A
• Filed: 01/04/1990
• Issued: 03/12/1991
• Est. Priority Date: 01/09/1989
• Status: Expired due to Term

• Current Assignee: Scope Medical, Inc.
• Original Assignee: Gary R. Hammerslag, Julius G. Hammerslag
• Inventors: Hammerslag, Gary R., Hammerslag, Julius G.
• Primary Examiner(s): Yasko, John D.
• Application Number:
  US07/461,049
• Time in Patent Office: 432 Days
• Field of Search: 604/95, 604/164, 604/170, 604/280, 604/281, 604/282, 128/657, 128/772
• US Class Current: 604/528
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• 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: A61M 25/09025 with sliding mandrils

Abstract

An elongate steerable implement is disclosed, which may be either a steerable guidewire or catheter for coronary angioplasty applications. A floppy steerable tip on a steering region at the distal end of the implement and a control device at the proximal end are connected by means of a plurality of axially movable deflection wires extending throughout the implement. Manipulation of the control permits deflection of the steering region throughout a full 360° range of motion about the axis of the implement, without axial rotation or "torquing" thereof.

Claims

1. A steerable guidewire for percutaneous transluminal insertion into the coronary vascular system and controlled negotiation of branches and turns therein to guide an angioplasty catheter to an arterial stenosis or other treatment site, said guidewire comprising:

an elongate flexible shaft having a proximal and a distal end and at least one lumen extending therethrough, said distal end being provided with a floppy, resilient tip;

a deflection wire guide disposed within a steering region on the distal end of said flexible shaft, said wire guide secured to substantially prevent axial displacement thereof;

a deflection wire anchor disposed within the steering region distally of the wire guide; and

at least three deflection wires axially movably disposed within the lumen of said flexible shaft and extending from a distal point of attachment to the wire anchor throughout the length of the flexible shaft to the proximal end thereof;

wherein axial movement of any one of said deflection wires in a proximal direction displaces the axis of the steering region in a unique lateral direction, and through combinations of proximal axial displacement of said deflection wires, said steering region is caused to deflect laterally and rotate throughout a full 360°

range of motion about the axis of the flexible shaft.

29. The steering device of claim 1, wherein the deflection wire anchor comprises an elongate tubular body for receiving a deflection wire therethrough.

2. A steering device for controlling a flexible steering region on the distal end of an elongate implement, comprising:

a deflection wire guide having proximal and distal ends positioned within the steering region of said elongate implement;

a deflection wire anchor displaced axially in a distal direction from the wire guide; and

at least one deflection wire secured to the deflection wire anchor and extending proximally adjacent the deflection wire guide;

wherein the deflection wire is axially movably disposed in contact with the wire guide.

3. A steering device as in claim 2, wherein the elongate implement comprises a flexible catheter.

4. A steering device as in claim 2 wherein the elongate implement comprises a flexible guidewire.

30. The steering device of claim 2, wherein the deflection wire guide comprises a proximal wire guide for guiding at least one deflection wire and wherein the deflection wire anchor comprises a distal wire guide for guiding at least one deflection wire.

5. A steerable implement, comprising:

an elongate housing for transmitting a first force in a distal direction;

a resilient tip on the distal end of the housing, said tip moveable between a first position on the axis of the housing and a second position displaced radially from the axis of the housing;

at least one deflection wire within the housing for selectively transmitting a second force in a proximal direction; and

a deflection wire anchor disposed in the housing for transmitting a radial component of said second force to the housing;

wherein movement of the deflection wire in a proximal direction along the housing deflects the tip from the first position to the second position.

6. A steerable implement as in claim 5, wherein the housing comprises a flexible coiled wire.

7. A steerable implement as in claim 6, comprising at least three deflection wires approximately equally radially spaced about the housing and extending axially in the proximal direction so that selective proximal movement of the deflection wires will result in a full 360°

range of motion of said tip.

8. A steerable implement as in claim 7, comprising four deflection wires radially symmetrically spaced about the axis of the housing.

31. The steerable implement of claim 5, having a plurality of deflection wires and wherein the deflection wire anchor comprises a plurality of distal wire guides equal in number to the number of deflection wires.

9. A steerable implement, comprising:

an elongate flexible housing having proximal and distal ends and a central lumen extending therebetween, the distal end of the housing being flexible in a lateral direction;

an axially extending steering post secured in the housing, and adapted to displace the distal end of the housing in a lateral direction, said steering post having a wire anchor region and a wire guide region thereon;

at least one deflection wire having proximal and distal ends extending along the housing, said wire being attached to the anchor region of the steering post; and

a control at the proximal end of the housing for engaging the proximal end of the deflection wire to cause said deflection wire to be displaced axially, in relation to said catheter;

wherein the axis of the steering post is displaced laterally in response to axial displacement of the deflection wire, thereby causing the distal end of said housing to bend out of the line of the housing longitudinal axis.

10. A steerable implement as in claim 9, comprising at least three deflection wires.

11. A steerable implement as in claim 9, comprising four deflection wires.

12. The implement of claim 9, further comprising a flexible tip attached to the distal end of the housing.

13. A steerable implement as in claim 9, wherein the cross-sectional area of the steering post at a point intermediate the anchor region and guide region is less than the cross-sectional area of the steering post in at least one of the guide region and the anchor region.

32. The steerable implement of claim 9, wherein the wire anchor region comprises at least one distal wire guide for guiding at least one deflection wire.

14. A steering device for a steerable guidewire of the type made from an elongate flexible tubular spring coil having proximal and distal ends, a central lumen extending therethrough and a flexible steering region, comprising:

a central post having proximal and distal ends, secured against axial movement in the proximal direction relative to the spring coil and extending axially within the steering region of the spring coil;

at least one proximal wire guide for guiding at least one deflection wire; and

at least one deflection wire extending axially through the spring coil and through a unique proximal wire guide to the distal end of the post.

15. The steering device of claim 14, additionally comprising a distal wire guide for each deflection wire.

16. The steering device of claim 15, wherein the post extends in a distal direction beyond the distal end of the distal wire guide, so as to cause the steering region to form an elbow bend when a deflection wire is displaced in an axial direction.

17. The steering device of claim 15, wherein the number of deflection wires, proximal wire guides and distal wire guides are all equal.

18. The steering device of claim 14, wherein there are at least three deflection wires, so as to allow complete 360°

steerability of the guidewire.

19. The steering device of claim 14, wherein there are two deflection wires, and wherein axial proximal displacement of a first of the two deflection wires causes the steering region to be displaced laterally such as to negotiate a branch or turn in an artery and axial proximal displacement of the second of the two deflection wires causes the laterally displaced steering region to substantially straighten out again.

20. A steering device for controlling a flexible steering region on the distal end of an elongate implement, comprising:

a steering post adapted to displace the distal end of the implement in a lateral direction;

a plurality of deflection wires, wherein axial displacement of the deflection wires causes lateral deflection of the distal end of the implement;

a plurality of proximal wire guides secured to the steering post for guiding each of the plurality of deflection wires; and

a plurality of distal wire guides secured to the steering post distally of the proximal wire guides, wherein each of the plurality of distal wire guides correspond to each of the deflection wires.

22. The steering device of claim 20, wherein there are at least three deflection wires, each deflection wire having a unique proximal wire guide and a unique distal wire guide.

23. The steering device of claim 20, wherein each of the deflection wires is secured to the distal end of the post.

24. The steering device of claim 20, wherein there is a continuous wire looping across the distal end of the post to form two of the deflection wires.

25. The steering device of claim 24, wherein there are four deflection wires formed from two continuous wires looping across the distal end of the post.

26. The steering device of claim 20, wherein the proximal wire guides comprise elongate tubular bodies for receiving the corresponding deflection wire therethrough, the tubular bodies having inner diameters sufficient that a deflection wire extending therethrough is capable of reciprocal motion with sufficiently low friction that steering of the implement may be accomplished.

27. The steering device of claim 26, wherein the distal wire guides comprise elongate tubular bodies for receiving the corresponding deflection wire therethrough, the tubular bodies having inner diameters sufficient that a deflection wire extending therethrough is capable of reciprocal motion with sufficiently low friction that steering of the implement may be accomplished.

28. The steering device of claim 20, comprising two deflection wires, thereby providing for lateral displacement of the guidewire throughout a single plane.

21. The steering device of claim 21, wherein the proximal wire guides are spaced substantially equidistant around the periphery of the post.