Steerable medical device

• US 5,108,368 A
• Filed: 09/17/1990
• Issued: 04/28/1992
• Est. Priority Date: 01/04/1990
• 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:
  US07/583,819
• Time in Patent Office: 589 Days
• Field of Search: 604/95, 604/164, 604/170, 604/194, 604/227, 604/280-283, 128/657, 128/756, 128/757, 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 25/09 Guide 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. In another embodiment, a steering ribbon is disclosed which permits steering by lateral deflection of the tip into a deflected or bent position and then permits straightening the tip back to its original position.

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 housing having a proximal and a distal end and at least one lumen extending therethrough;

a flexible steering ribbon secured within the lumen, and adapted to displace the distal end of the housing in a lateral direction;

at least one deflection wire guide disposed on the steering ribbon;

at least one deflection wire anchor disposed on the steering ribbon distally of the wire guide; and

at least two deflection wires axially movably disposed within the lumen of the flexible housing 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 one of said deflection wires in a proximal direction displaces the axis of a portion of the housing in a lateral direction and axial movement of the other of said deflection wires in a proximal direction returns the axis of a portion of the housing to its original, undisplaced position.

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

a steering ribbon positioned within the steering region of said elongate implement;

at least two deflection wire guides having proximal and distal ends positioned on each of at least two sides of said steering ribbon;

at least two deflection wires secured relative to the steering ribbon and extending proximally adjacent the deflection wire guide;

wherein axial proximal displacement of a first of said 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 said two deflection wires causes the laterally displaced steering region to substantially straighten out again.

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.

5. A steering device as in claim 2, wherein said steering ribbon is of rectangular cross section.

6. 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;

a flexible steering ribbon secured within the lumen, and adapted to displace the distal end of the housing in a lateral direction;

a hinge on the steering ribbon to provide a predicted flexing point along the ribbon; and

at least two deflection wires secured to the ribbon;

wherein movement of the first of the two deflection wires in a proximal direction along the housing deflects the distal end from a first position to a second position and movement of the second of the two deflection wires in a proximal direction deflects the distal end from the second position back to the first position.

7. A steerable guidewire as in claim 6, wherein said at least two deflection wires are spaced directly opposite each other with respect to the steering ribbon so that selective proximal movement of the deflection wires will result in a range of motion of said tip within a plane which includes the axis of the flexible shaft.

8. A steerable guidewire as in claim 6, wherein said hinge comprises a living hinge.

9. A steerable guidewire as in claim 6, wherein said hinge comprises an indentation in said steering ribbon.

10. A steerable guidewire as in claim 8, wherein said hinge comprises a cut out portion in the steering ribbon.

11. A steerable implement as in claim 6, wherein said hinge comprises a space between two axially separate components disposed on said ribbon.

12. A steerable implement as in claim 11, wherein said components comprise a steering guide and anchor.

13. 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 ribbon secured in the housing, and adapted to displace the distal end of the housing in a lateral direction, said steering ribbon having a hinge thereon for allowing motion in either of two directly opposite directions;

at least two deflection wires having proximal and distal ends extending along the housing, said wires being secured to the steering ribbon; and

a control at the proximal end of the housing for engaging the proximal ends of the deflection wires to enable said deflection wires to be displaced axially, in relation to said implement;

wherein the axis of at least a portion of the steering ribbon is displaced laterally in one of the directions of movement of said hinge in response to axial displacement of the first of said deflection wires, thereby causing the distal end of said housing to bend out of the line of the housing longitudinal axis, and the axis of the displaced portion of the steering ribbon is returned to its original position by axial displacement of the second of the deflection wires.

14. A steerable implement as in claim 13, comprising two deflection wires.

15. The implement of claim 13, further comprising a flexible tip attached to the distal end of the housing.

16. A steerable implement as in claim 13, wherein the cross-sectional area of the steering ribbon at the hinge is less than the cross-sectional area of the steering ribbon adjacent to the hinge.

17. A method of steering a guidewire through branches and turns in the coronary vascular system, said guidewire of the type having at least two deflection wires for steering said guidewire and an elongate flexible shaft with a proximal and a distal end, said distal end being provided with a tip which is deflectable out of alignment with the adjacent portion of guidewire to negotiate a turn and then back into substantial alignment with the adjacent portion of guidewire, said method comprising:

introducing said guidewire into the coronary vascular system;

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

rotating said guidewire until said turn is aligned with a direction in which said tip is deflectable;

steering said tip of said guidewire into said turn by axial displacement of a first of said deflection wires to deflect the tip out of alignment with the adjacent portion of guidewire and in the direction of the turn;

advancing said guidewire through said turn; and

thereafter

substantially straightening said guidewire by axial displacement of the second of said deflection wires.

18. 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 housing having aproximal and a distal end and at least one lumen extending therethrough;

a flexible steering ribbon secured within the lumen, and adapted to displace the distal end of the housing in a lateral direction;

at least two deflection wires axially movably disposed within the lumen of the flexible housing and extending from a distal point of attachement to the steering ribbon throughout the length of the flexible shaft to the proximal end thereof; and

wherein axial movement of one of said deflection wires in a proximal direction displaces the axis of a portion of the housing in a lateral direction and axial movement of the other of said deflection wires in a proximal direction returns the axis of a portion of the housing to its original, undisplaced position.

19. A steerable guidewire as in claim 18, further comprising a hinge on the steering ribbon.

20. A steerable guidewire as in claim 19, wherein the hinge comprises a region of reduced rigidity in the steering ribbon.

21. A steerable guidewire as in claim 19, wherein the cross-sectional area of the steering ribbon at the hinge is less than the cross-sectional area of the steering ribbon adjacent to the hinge.