Locking handle deployment mechanism for medical device and method

• US 20030074045A1
• Filed: 06/19/2002
• Published: 04/17/2003
• Est. Priority Date: 10/12/2001
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Feller, Frederick III, Buzzard, Jon
• Granted Patent: US 6,866,669 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 2025/09116 Design of handles or shafts or gripping surfaces thereof for manipulating guide wires

Abstract

A system for delivering at least one medical device to a desired location for treatment, and then selectively deploy it in position, includes an improved handle. One of the possible features of the handle may be to selectively hold the delivery system components at any desired configuration during deployment and positioning of the medical device. Another possible feature of the handle may be more than one mode of operation, in which the deployment of the medical device can selectively proceed at more than one speed. Yet another possible feature of the handle may be a locking mechanism that resists inadvertent or accidental movement or retraction of the stent delivery system components during packaging, sterilization, shipping, storage, handling and preparation of the stent delivery system.

Claims

1. A medical device delivery system for therapeutically treating a patient, comprising:

an inner shaft, having proximal and distal ends;

a tubular outer sheath, at least a portion of which surrounds a portion of the inner shaft member;

a medical device within the outer sheath in an initial configuration;

a handle operatively coupled with the inner shaft and the outer sheath;

the handle having a first and second actuator for adjusting the relative positions of the inner shaft and the outer sheath, each of the first and second actuators providing a different amount of mechanical advantage between an input to one of the first and second actuators by a physician and a resulting relative position of the inner shaft and the outer sheath respectively; and

a locking member that releasably holds the outer sheath relative to the inner shaft in an initial configuration, thereby holding the outer sheath in the initial configuration and tending to resist inadvertently uncovering the medical device.

2. The medical device delivery system of claim 1, wherein the locking member has first and second surfaces, such that in the initial configuration the first surface releasably holds a component attached to the outer sheath, and the second surface releasably holds a portion of the handle.

3. The medical device delivery system of claim 1, wherein the locking member has one or more flanges that releasably resist movement of one or more of the first and second actuators.

4. The medical device delivery system of claim 1, wherein the first actuator provides a mechanical advantage of 1:

1.

5. The medical device delivery system of claim 1, wherein the first actuator is adapted to slide along a longitudinal slot defined by the handle.

6. The medical device delivery system of claim 1, wherein the second actuator provides a mechanical advantage greater than 1:

1, to facilitate an operator to overcome initial resistance to changing the initial relative position of the inner shaft and the outer sheath.

7. The medical device delivery system of claim 1, wherein the second actuator is adapted to rotate around a threaded base.

8. The medical device delivery system of claim 1, wherein the second actuator provides a variable mechanical advantage that can be selected by an operator from among a pre-selected range of possible mechanical advantages.

9. The medical device delivery system of claim 1, wherein on of the first and second actuators is formed as a lever.

10. The medical device delivery system of claim 1, further comprising a guidewire lumen for slidably receiving a flexible guidewire.

11. The medical device delivery system of claim 1, wherein the medical device is a stent.

12. The medical device delivery system of claim 11, wherein the stent is of the self-expanding type.

13. The medical device delivery system of claim 1, further comprising a unified actuator knob, wherein the first actuator is a slider coupled to the outer shaft adapted to slide with respect to the handle, wherein the second actuator is a threaded coupling between the knob and the slider;

such that the unified actuator knob is adapted to operate both the first and second actuators.

14. A handle for manipulating a medical device delivery system for therapeutically treating a patient, comprising:

a housing;

first and second shaft members;

the first shaft member being affixed to the housing;

the second shaft member being movably coupled to the first shaft member, such that the second shaft member can be moved longitudinally with respect to the first shaft member;

first and second means for selectively moving the second shaft member with respect to the first shaft member;

the first means being adapted for precise and sensitive adjustment of the position of the second shaft member, and the second means being adapted for rapid and relatively large-scale movement of the second shaft member; and

a locking member that releasably holds the first and second shafts in a constant initial relative position.

15. A handle for manipulating a stent delivery system to therapeutically treat a patient, comprising:

a housing having a slot and a drive shoulder;

inner and outer shaft members;

the inner shaft member being affixed to the housing;

at least a portion of the outer shaft member surrounding a portion of the inner shaft member, such that the outer shaft member can be moved longitudinally with respect to the inner shaft member;

a hub assembly affixed to a proximal end of the outer shaft member and being longitudinally movable within the housing;

the hub assembly having a grasping knob and a threaded drive member;

the grasping knob extending outward through the housing slot;

wherein the hub assembly may be directly moved in a longitudinal direction relative to the inner shaft member by pulling on the grasping knob;

a rotatable actuator having a bearing surface and being mounted about the threaded drive member in threaded engagement;

such that rotation of the actuator in a selected direction about the threaded drive member causes the rotatable actuator to press on the bearing surface, thereby pulling in a proximal direction the threaded drive member, hub and outer shaft member;

whereby the position of the outer shaft member relative to the inner shaft member may be adjusted by the rotatable actuator in a precise and sensitive manner, while movement of the grasping knob causes rapid and relatively large-scale movement of the outer shaft member relative to the inner shaft member; and

a locking member that releasably holds the inner and outer shafts in a constant initial relative position.

17. The method as set forth in claim 15, further comprising, between steps (d) and (e), the additional steps of:

evaluating in greater detail the position of the medical device compared to the position of the desired site to be treated; and

adjusting the position of the medical device delivery system based on the evaluation.

19. The method as set forth in claim 17, further comprising, between steps (d) and (e), the additional steps of:

evaluating in greater detail the position of the medical device compared to the position of the desired site to be treated; and

adjusting the position of the medical device delivery system based on the evaluation.

16. A method for therapeutically treating a patient, comprising the steps of:

(a) providing a medical device delivery system having proximal and distal ends;

a handle near the proximal end;

a medical device for delivery by the delivery system and for performing a therapeutic procedure at a desired site for treatment;

a delivery mechanism for selectively and progressively releasing the medical device; and

a locking member that holds the delivery mechanism in an initial configuration, the locking member tending to releasably resist inadvertent release of the medical device by the delivery mechanism;

wherein the medical device is positioned within the delivery mechanism;

wherein the handle has a first and second actuator coupled to the delivery mechanism;

(b) inserting the medical device delivery system along a body passage until the distal end of the delivery system is positioned at or near the desired site for treatment;

(c) unlocking the locking member;

(d) moving the first actuator on the handle a first selected amount;

such movement of the first actuator causing the delivery mechanism to move an amount at a first proportional rate in a precise manner, and causing the delivery mechanism to partially release the medical device;

(e) moving the second actuator on the handle, causing the delivery mechanism to move at a second greater proportional rate in a rapid manner, to fully release the medical device; and

(f) withdrawing and removing the medical device delivery system from the body passage, and allowing the medical device to remain at the desired site for treatment.

18. A method for therapeutically treating a patient, comprising the steps of:

(a) providing a medical device delivery system having proximal and distal ends;

a handle near the proximal end;

a medical device for delivery by the delivery system and for performing a therapeutic procedure at a desired site for treatment;

a delivery mechanism for selectively and progressively releasing the medical device; and

a locking member that holds the delivery mechanism in an initial configuration, the locking member tending to releasably resist inadvertent release of the medical device by the delivery mechanism;

wherein the medical device is positioned within the delivery mechanism;

the handle has a first and second actuator coupled to the delivery mechanism;

the first actuator is a rotatable knob; and

the second actuator is a longitudinal slider;

(b) inserting the medical device delivery system along a body passage until the distal end of the delivery system is positioned at or near the desired site for treatment;

(c) unlocking the locking member;

(d) rotating the first actuator on the handle a selected amount;

such rotation of the first actuator causing the delivery mechanism to move an amount in a precise manner, and causing the delivery mechanism to partially release the medical device;

(e) sliding the second actuator on the handle longitudinally, causing the delivery mechanism to move in a rapid manner, to fully release the medical device; and

(f) withdrawing and removing the medical device delivery system from the body passage, and allowing the medical device to remain at the desired site for treatment.