Steerable angioplasty device

• US 5,037,391 A
• Filed: 08/01/1990
• Issued: 08/06/1991
• Est. Priority Date: 01/09/1989
• Status: Expired due to Fees

• Current Assignee: Scope Medical, Inc.
• Original Assignee: Pilot Cardiovascular Systems, Inc.
• Inventors: Hammerslag, Gary R., Hammerslag, Julius G.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US07/562,455
• Time in Patent Office: 370 Days
• Field of Search: 604/95, 604/164, 604/170, 604/280-282, 128/657, 128/772
• US Class Current: 604/528
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• 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, comprising:

an axially elongate flexible housing having distal and proximate ends, said distal end being provided with a resilient tip;

a flexible steering region displaced intermediate said distal and proximate ends of said housing; and

at least one deflection wire for causing lateral deflection of said steering region upon axial displacement of said deflection wire along said housing.

2. The device of claim 1 wherein said steering region comprises a different material than the remainder of said body.

3. The device of claim 1, wherein said body comprises a wound coil.

4. The device of claim 3, wherein said coil has fewer revolutions per unit of axial distance along said body in said steering region.

5. The device of claim 1, wherein said body has a diameter less than 0.125 inches.

6. The device of claim 5, wherein said body has a diameter between 0.014 inches and 0.018 inches.

7. The device of claim 1, comprising at least three deflection wires.

8. A steering mechanism for a steerable guidewire having a flexible steering region, comprising:

a steering post secured to said steering region in a manner that substantially prevents axial displacement thereof yet permits lateral deflection of the axis of said steering post away from the axis of said steerable guidewire;

at least one deflection wire secured to said steering post; and

a control device for axially displacing said deflection wires so as to laterally displace said steering post and said steering region.

9. The steering mechanism of claim 8, wherein said steering post has proximal and distal ends and wherein said deflection wire has proximal and distal ends and the distal end of said deflection wire is secured at a point intermediate said proximal and distal ends of said steering post.

10. The steering mechanism of claim 8, wherein said control device comprises a pivotably mountable circular plate secured to said deflection wires.

11. The steering mechanism of claim 8, wherein said control device comprises a single lever secured to said deflection wires, said lever being displaceable to any position throughout a nearly hemispherical range of motion.

12. The steering mechanism of claim 8, wherein said control device is provided with a stop to prevent bending of said steering post or said guidewire beyond their elastic limits.

13. A method of steering a guidewire of the type having at least one deflection wire for steering said guidewire and an elongate flexible shaft with a proximal and a distal end, said distal end being provided with a tip, through branches and turns in the coronary vascular system, comprising:

introducing said guidewire into the coronary vascular system;

advancing said guidewire through the coronary vascular system until a branch or a turn is encountered;

steering said tip of said guidewire into said turn by axial displacement of said deflection wires and advancing said guidewire through said turn;

straightening said guidewire by axial displacement of said deflection wire; and

further advancing said guidewire through the coronary vascular system.

14. The method of claim 13, wherein said guidewire has more than one deflection wire and wherein the straightening step comprises axial displacement of a different deflection wire than the deflection wire axially displaced in the steering step.

15. The method of claim 13, wherein said guidewire has at least three deflection wires and wherein axial movement of any one of said deflection wires in a proximal direction causes lateral deflection of said tip and allows a full 360°

range of motion about the axis of said flexible shaft.

16. A steerable guidewire, comprising:

an elongate flexible housing having a diameter less than 0.125 inches and having proximal and distal ends and a central lumen extending therebetween, the distal end of said housing being flexible in a lateral direction; and

at least two deflection wires extending along the housing for causing lateral deflection of said distal end of said housing.

17. A steerable guidewire as in claim 16, additionally comprising a resilient tip on the distal end of said housing, said tip being movable between a first position on the axis of said housing and a second position displaced radially from the axis of said housing.

18. A steerable guidewire as in claim 16, wherein said housing has a diameter between 0.014 inches and 0.018 inches.

19. A steerable device for controlled negotiation through branches and turns, comprising:

an axially elongate body having distal and proximal ends and a central lumen therebetween;

a flexible steering region disposed intermediate said distal and proximal ends of said body;

a deflecting means within said central lumen; and

at least one deflection wire secured to said deflecting means for causing deflection of said steering region upon axial displacement of said deflection wire.

20. A guidewire as in claim 19, wherein there are at least three deflection wires so that through combinations of 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 said flexible shaft.

21. A guidewire as in claim 19, wherein said deflecting means is a steering post.

22. A guidewire as in claim 19, additionally comprising a support for said deflecting means wherein said deflecting means is in pivotable contact with said support.