RATCHET-SLIDE HANDLE AND SYSTEM FOR FIDUCIAL DEPLOYMENT

• US 20140243844A1
• Filed: 02/13/2014
• Published: 08/28/2014
• Est. Priority Date: 02/26/2013
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Clancy, Michael, McGrath, Darach, Toomey, Ciaran, Campbell, Triona, Mulcahy, Patrick, Keady, Fionan
• Granted Patent: US 9,522,264 B2
• Time in Patent Office: Days
• US Class Current: 606/117
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00407 Ratchet means
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 25/013 One-way gripping collars
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027

Abstract

Embodiments include a fiducial deployment system with a handle configured for actuation of same. A fiducial may include one or more protuberances configured to engage one or more slots in a needle of the system. The needle may be configured to deliver a plurality of fiducials to a target location in serial fashion, one at a time. In certain embodiments, echogenic placement of fiducials may present certain advantages. The handle includes an actuation mechanism with a toothed rack and actuation member(s) configured for incrementally or otherwise controlledly deploying one or more fiducials at a time by advancing a stylet through and/or retracting the body of a slotted needle in which fiducials are disposed with a fiducial protrusion extending into the needle slot, which also includes retaining structures that do not impede the needle lumen.

Claims

1. A ratcheted handle for a fiducial deployment system comprising:

a fiducial deployment needle configured to retain and to distally deploy, in a controlled serial manner, a plurality of fiducials;

an advancement mechanism for said fiducial deployment, the advancement mechanism comprising;

an elongate handle member defining a central longitudinal axis;

a stylet disposed longitudinally through the needle, extending proximally into the handle member;

a central rack member affixed to the stylet and longitudinally movable in the handle, the central rack member including a plurality of laterally-protruding teeth; and

at least one tooth-engagement actuation member

disposed movably through a wall of the handle member and

engaged into contact with at least one tooth of the rack.

2. The handle of claim 1, where the at least one tooth-engagement actuation member includes an opposing pair of tooth-engagement sliders, each disposed longitudinally, reciprocatingly slidably through a handle aperture that limits the longitudinal sliding reciprocation distance,

where moving the sliders distally along a full length of the handle aperture engages and moves the rack with the stylet distally by a distance corresponding to a distal-needle-end deployment of a predetermined number of the plurality of fiducials.

3. The handle of claim 2, where the rack is spring-urged distally, the sliders are spring-urged proximally, or both.

4. The handle of claim 2, where the rack teeth, the sliders or both, are configured for unidirectional distal-advancing engagement when the sliders are moved distally, and are configured to allow non-rack-moving proximal reciprocation of the sliders from a distal aperture end toward a proximal aperture end.

5. The handle of claim 2, comprising a keeper member that effectively prevents proximal movement of the rack relative to the handle member.

6. The handle of claim 2, where the teeth are recessible into the rack when subjected to proximal contact from the sliders, the sliders are movable laterally relative to the teeth sufficiently to slide proximally therepast without proximally moving the rack, or both.

7. The handle of claim 2, where the rack includes indicia, viewable through a window in the handle member, of the number of fiducials deployed by distalward movement of the rack.

8. The handle of claim 1, where the at least one tooth-engagement actuation member includes at least one slider with a button oriented generally transverse to the longitudinal axis, where the button is biased or urged to engage against or between teeth of the rack.

9. The handle of claim 8, where the at least one tooth-engagement actuation member includes two sliders, each with the button, and operates effectively to move the rack and stylet distally relative to the handle member when the buttons are engaged and the sliders are moved distally relative to the handle member.

10. The handle of claim 8, where the rack includes indicia, viewable through a window in the handle member, of the number of fiducials deployed by distalward movement of the rack.

11. The handle of claim 8, where the rack is spring-urged distally, the sliders are spring-urged proximally, or both.

12. The handle of claim 8, comprising a keeper member that effectively prevents proximal movement of the rack relative to the handle member.

13. The handle of claim 1, where the actuation member is configured as a button that is depressible through the handle member wall, and that button is biased or urged generally transversely relative to and away from the longitudinal axis of the handle member.

14. The handle of claim 13, where the teeth are depressible into the rack by depressing actuation of the button toward the longitudinal axis;

where the rack is urged distally along the longitudinal axis by a spring; and

where a distal-most non-depressed tooth engages a keeper element effectively to prevent distal rack movement unless that distal-most tooth is depressed out of engagement with the keeper element.

15. The handle of claim 14, where the button is biased by a spring.

16. The handle of claim 14, where the keeper element comprises an indentation of an inner handle wall surface configured to capture and effectively to stop distalward movement of a non-depressed tooth.

17. The handle of claim 14, where the rack and the handle wall each are generally cylindrical with an outer diameter of the rack—

exclusive of the teeth—

about the same or slightly less than an inner diameter of the handle wall, and where the inner diameter wall includes a recessed track allowing longitudinal movement of non-depressed teeth of the rack, and a distal end of the recessed track comprises the keeper element.

18. The handle of claim 14, where the rack includes indicia, viewable through a window in the handle member, of the number of fiducials deployed by distalward movement of the rack.

19. The handle of claim 1, where a single depression of the button depresses one tooth and effects distally-urged movement of the rack with the stylet by a distance corresponding to a distal-needle-end deployment of a predetermined number of the plurality of fiducials.

20. A medical device handle configured for controlled incremental lengthwise stylet advancement through a cannula such as a fiducial needle, the handle comprising:

an elongate outer handle body defining a longitudinal handle lumen;

an elongate cannula attached directly or indirectly to a distal end of the handle body, the cannula defining a longitudinal cannula lumen in mechanical communication with the handle lumen;

a rack member, including a plurality of longitudinally-aligned protruding teeth, where the rack member is disposed—

and is distally spring-biased—

within the handle lumen;

a stylet extending distally from the rack member into the cannula lumen; and

at least one actuation member with a portion of the actuation member engaging against one of or between two or more of the plurality of teeth, where actuating of the actuation member by moving it transversely against, and/or longitudinally relative to, the teeth is effective to move the rack distally by a predetermined increment.