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

• US 20030028236A1
• Filed: 07/31/2001
• Published: 02/06/2003
• 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.
• Granted Patent: US 6,755,854 B2
• Time in Patent Office: Days
• 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 the 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 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 to the control mechanism at an angle to the line of motion of the restraining sheath.

2. The control device of claim 1, wherein:

the angle at which the actuating force is to be applied to the control mechanism is between 30 and 90 with the line of motion of the restraining sheath.

3. The control device of claim 1, wherein:

the angle at which the actuating force is to be applied to the control mechanism is substantially perpendicular to the line of motion of the restraining sheath.

4. The control device of claim 1, wherein:

the actuating force is placed on a movable component of the control mechanism which 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 rack being adapted to receive the actuating force for retracting the retraining sheath, the pinion being coupled with a slider assembly attached to the proximal end of the retraining sheath and movable within the housing.

11. The control device of claim 10, further including:

a gear connected to the pinion and means connecting the slider assembly to the rear for translating the slider assembly when the gear is rotated by the rotation of the pinion.

12. 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 the self-expanding medical device, the restraining sheath being coaxially 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 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 to the control mechanism at an angle to the line of motion of the restraining sheath.

13. The control device of claim 12, 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.

14. The control device of claim 13, wherein:

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

15. The control device of claim 14, wherein:

the control mechanism includes a gear connected to the pinion and means connecting the slider assembly to the rear for translating the slider assembly when the gear is rotated by the rotation of the pinion.

16. The control device of claim 15, 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.

17. The control device of claim 14, 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.

18. The control device of claim 12, wherein:

the angle at which the actuating force is to be applied to the control mechanism is between 30 and 90 with the line of motion of the restraining sheath.

19. The control device of claim 12, wherein:

the angle at which the actuating force is to be applied to the control mechanism is substantially perpendicular to the line of motion of the restraining sheath.

20. The control device of claim 12, wherein:

the actuating force is placed on a movable component of the control mechanism which 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.

21. The control device of claim 20, 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.

22. The control device of claim 21, 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.

23. The control device of claim 22, 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.