Control device and mechanism for deploying a self-expanding medical device

• US 6,755,854 B2
• Filed: 07/31/2001
• Issued: 06/29/2004
• Est. Priority Date: 07/31/2001
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Gillick, Matthew J., Stalker, Kent C. B.
• Primary Examiner(s): Bui, Vy Q.
• Application Number:
  US09/919,491
• Publication Number:
  US 20030028236A1
• Time in Patent Office: 1,064 Days
• Field of Search: 623/1.11, 623/1.13, 623/1.15, 623/903, 606/108, 606/191, 606/194, 606/198, 606/200
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube

Abstract

A control device and mechanism for deploying a self-expanding medical device includes an actuating mechanism which allows the user to retract a restraining sheath from the self-expanding medical device by using a motion that is in angle to the line of motion of the restraining sheath, which helps prevent movement of the catheter portion of the control device within the patient. The control mechanism allows the physician to obtain a longer retracting stroke to the restraining sheath with a shorter actuating motion reducing the amount of manual actuation needed to be performed by the physician when retracting the sheath. The control mechanism can also reduce the amount of actuating force needed to retract the restraining sheath by utilizing springs or biasing members in connection with the actuating mechanism which combines with the actuating force supplied by the physician to cause the retraction of the restraining sheath.

Claims

1. A control device for deploying a self-expanding medical device within a body vessel, the control device comprising:

a restraining sheath having a proximal end and a distal end, the restraining sheath being adapted to extend over a self-expanding medical device to maintain the medical device in a collapsed position and to be retractable to expose the collapsed medical device for deployment; and

a control mechanism including a slider assembly coupled to the proximal end of the restraining sheath for retracting the restraining sheath, the slider assembly being movable in a line of motion, the retraction of the restraining sheath being actuated by an actuating force applied by a user to a movable component of the control mechanism which moves in a linear path which is at a constant angle substantially different from zero degree to the line of motion of the slider assembly.

2. The control device of claim 1, wherein:

the angle at which the actuating force is to be applied to the movable component of the control mechanism is between about 30 and 90 degrees with the line of motion of the slider assembly.

3. The control device of claim 1, wherein:

the angle at which the actuating force is to be applied to the movable component of the control mechanism is substantially perpendicular to the line of motion of the slider assembly.

4. The control device of claim 1, wherein:

the actuating force placed on the movable component of the control mechanism causes translation of the movable component, the control mechanism causing the length of retraction of the restraining sheath to be larger than the length of translation of the movable component.

5. The control device of claim 4, wherein:

the control mechanism includes means for varying the length of retraction of the restraining sheath in response to the length of translation of the movable component.

6. The control device of claim 4, wherein:

the control mechanism includes means for reducing the amount of actuating force needed to translate the movable component to fully retract the restraining sheath from the medical device.

7. The control device of claim 6, wherein:

the means for reducing the amount of actuating force needed to translate the movable component are biasing means coupled to the movable component which places a force on the movable component in the direction of translation of the movable component.

8. The control device of claim 1, further including:

an elongate inner member upon which the restraining sheath is coaxially disposed, the inner member having a proximal end coupled with the control mechanism and a distal end having a mounting portion for mounting the self-expanding medical device.

9. The control device of claim 8, further including:

a housing for the control mechanism, the proximal end of the restraining sheath being movable in the housing in a line of motion with the proximal end of the inner member being affixed within the housing to maintain the inner member stationary as the restraining sheath is being retracted.

10. The control device of claim 9, wherein:

the control mechanism includes a movable rack and pinion assembly mounted within the housing, the movable component being a movable rack adapted to receive the actuating force for retracting the retraining sheath, the pinion being coupled with the slider assembly.

11. A control device for deploying a self-expanding medical device within a body vessel, the control device comprising:

a housing;

a catheter system coupled with the housing, the catheter system including a restraining sheath having a proximal end and a distal end and an inner member having a proximal end mounted within the housing and a distal end having a mounting portion for mounting a self-expanding medical device, the restraining sheath being disposed over the inner member with the distal end of the restraining sheath being extendable over the self-expanding medical device to maintain the medical device in a collapsed position, the restraining sheath being retractable to expose the collapsed medical device for deployment; and

a control mechanism mounted within the housing and including slider assembly coupled to the proximal end of the restraining sheath for retracting the restraining sheath, the slider assembly being movable in a line of motion, the retraction of the restraining sheath being actuated by an actuating force applied by a user to a movable component of the control mechanism which moves in a linear path which is at a constant angle substantially different from zero degree to the line of motion of the slider assembly.

12. The control device of claim 11 wherein:

the proximal end of the restraining sheath is movable within the housing in a line of motion with the proximal end of the inner member being affixed within the housing to maintain the inner member stationary as the restraining sheath is being retracted.

13. The control device of claim 12, wherein:

the control mechanism includes a movable rack and pinion assembly mounted within the housing, the movable component being a movable rack adapted to receive the actuating force for retracting the retraining sheath, the pinion being coupled with the slider assembly.

14. The control device of claim 13, wherein:

the movable rack is coupled to biasing element which places a force on the movable rack which reduces the actuating force needed to translate the movable rack in order to retract the restraining sheath.

15. The control device of claim 11, wherein:

the angle at which the actuating force is to be applied to the moveable component of the control mechanism is between 30 and 90 with the line of motion of the sliding assembly.

16. The control device of claim 11, wherein:

the angle at which the actuating force is to be applied to the movable component of the control mechanism is substantially perpendicular to the line of motion of the sliding assembly.

17. The control device of claim 11, wherein:

the actuating force placed on the movable component of the control mechanism causes translation of the movable component, the control mechanism causing the length of retraction of the restraining sheath to be larger than the length of translation of the movable component.

18. The control device of claim 17, wherein:

the control mechanism includes means for varying the length of retraction of the restraining sheath in response to the length of translation of the movable component.

19. The control device of claim 18, wherein:

the control mechanism includes means for reducing the amount of actuating force needed to translate the movable component to fully retract the restraining sheath from the medical device.

20. The control device of claim 19, wherein:

the means for reducing the amount of actuating force needed to translate the movable component are biasing means coupled to the movable component which places a force on the movable component in the direction of translation of the movable component.

21. A control device for deploying a self-expanding medical device within a body vessel, the control device comprising:

an inner member having a proximal portion and a distal end and being adapted to receive a self-expanding medical device;

a restraining sheath adapted to extend over the self-expanding medical device to maintain the self-expanding medical device in a collapsed position, the restraining sheath being retractable to expose the self-expanding medical device for deployment; and

a control mechanism mounted within a housing, the control mechanism coupled with the restraining sheath for moving the restraining sheath to expose the self-expanding medical device, wherein the proximal portion of the inner member extends within the housing and defines a line of motion, the movement of the restraining sheath being accomplished by an actuating force applied by the user to a control member which moves in a linear path being at a constant angle substantially different from zero degree with the line of motion defined by the proximal portion of the inner member.

22. The control device of claim 21, wherein:

the direction of the actuating force applied by the user to the movable component of the control mechanism is between about 30 and 90 degrees with the line of motion defined by the proximal portion of the inner member.

23. The control device of claim 21, wherein:

the direction of the actuating force applied by the user to the movable component of the control mechanism is substantially perpendicular to the line of motion defined by the inner member.

24. The new control device of claim 21, wherein:

the inner member includes a lumen for receiving a guide wire.

25. A control device for deploying a self-expanding medical device within a body vessel, the control device comprising:

a housing;

a restraining sheath adapted to extend over the self-expanding medical device to maintain a self-expanding medical device in a collapsed position, the restraining sheath being retractable to expose the self-expanding medical device for deployment; and

a control mechanism associated with the housing and coupled to the restraining sheath for moving the restraining sheath to expose the self-expanding medical device, the control mechanism including a control knob within the housing and a sliding component which moves substantially linearly within the housing, the sliding component being coupled to the restraining sheath and being movable by an actuating motion applied by the user to the control knob, which control knob moves in a linear fashion to form a constant angle substantially different from zero degree with the linear movement of the sliding component.

26. The control device of claim 25, wherein:

the movement of the control knob is substantially perpendicular to the linear movement of the sliding component.

27. A control device for deploying a self-expanding medical device within a body vessel, the control device comprising:

a restraining sheath having a proximal end and a distal end, the restraining sheath being adapted to extend over a self-expanding medical device to maintain the medical device in a collapsed position and to be retractable to expose the collapsed medical device for deployment;

an elongate inner member upon which the restraining sheath is disposed, the inner member having a mounting portion for mounting the self-expanding medical device; and

a housing associated with a control mechanism, the control mechanism including a slider assembly movable within the housing and coupled to the proximal end of the restraining sheath for retracting the restraining sheath in a line of motion, the control mechanism including a movable rack and pinion assembly mounted within the housing, the movable rack being adapted to receive an actuating force for retracting the retraining sheath, the pinion assembly being coupled with the slider assembly, a gear connected to the pinion and means connecting the slider assembly to the gear for translating the slider assembly when the gear is rotated by the rotation of the pinion, the retraction of the restraining sheath being actuated by an actuating force applied by a user to the movable rack which moves in a linear direction which is at a constant angle substantially different from zero degree to the line of the restraining sheath, the proximal end of the inner member being affixed within the housing to maintain the inner member stationary as the restraining sheath is being retracted.

28. A control device for deploying a self-expanding medical device within a body vessel, the control device comprising:

a housing;

a catheter system coupled with the housing, the catheter system including a restraining sheath having a proximal end and a distal end and an inner member having a proximal end mounted within the housing and a distal end having a mounting portion for mounting a self-expanding medical device, the restraining sheath being disposed over the inner member with the distal end of the restraining sheath being extendable over the self-expanding medical device to maintain the medical device in a collapsed position, the restraining sheath being retractable to expose the collapsed medical device for deployment, the proximal end of the restraining sheath being movable within the housing and the proximal end of the inner member being affixed within the housing to maintain the inner member stationary as the restraining sheath is being retracted; and

a control mechanism mounted within the housing, the control mechanism including a slider assembly coupled to the proximal end of the restraining sheath for retracting the restraining sheath in a line of motion, the retraction of the restraining sheath being actuated by an actuating force applied by a user to a movable rack which moves in a linear direction which is at a constant angle substantially different from zero degree to the line of motion of the restraining sheath, the control mechanism including a pinion assembly coupled with the slider assembly, a gear connected to the pinion assembly and means connecting the slider assembly to the gear for translating the slider assembly when the gear is rotated by the rotation of the pinion.

29. The control device of claim 28, wherein:

the gear has a larger diameter than the pinion to cause the length of retraction of the restraining sheath to be larger than the length of translation of the movable rack.