System and method for fiducial deployment

Patent metadata

Field	Value
Publication number	US-9072542-B2
Application number	US-96406210-A
Country	US
Kind code	B2
Filing date	Dec 9, 2010
Priority date	Dec 18, 2009
Publication date	Jul 7, 2015
Grant date	Jul 7, 2015

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 may include structures configured for incrementally or otherwise controlledly deploying one or more fiducials by advancing a stylet through and/or retracting the body of a needle in which fiducials are disposed.

First claim

The invention claimed is:

1. A handle for a fiducial deployment system comprising:
a first handle member attached to an elongate outer sheath, the outer sheath including a sheath lumen longitudinally disposed therethrough;
a second handle member disposed longitudinally slidably along the first handle member, the second handle member attached to an elongate needle disposed longitudinally slidably through the sheath lumen, wherein the needle includes a needle lumen disposed longitudinally therethrough;
a stylet disposed longitudinally slidably through the needle lumen;
a plurality of at least three separate and independent fiducials disposed in the needle lumen, where each of the fiducials includes a predetermined fiducial body length between end termini of the fiducial; and
an advancement mechanism attached to a proximal portion of the second handle and to the stylet in a manner configured for effecting longitudinal movement of one of the stylet and the needle relative to the other of the stylet and the needle by predetermined increments, where the predetermined increments are the same distance as the predetermined fiducial body lengths.

2. The handle of claim 1 , further comprising a third handle member disposed longitudinally positionable relative to the first handle member and configured for incrementally fixable, longitudinally-adjustable attachment of the first handle member to an external device.

3. The handle of claim 2 , wherein the third handle member is configured to attach to a working channel of an endoscope.

4. The handle of claim 1 , wherein the advancement mechanism comprises a threaded rotatable advancement member in mechanical communication with the stylet and an anchor member attached to the second handle member, the advancement mechanism configured such that rotation of the advancement member relative to the anchor member will move the stylet longitudinally relative to the second handle member.

5. The handle of claim 4 , wherein the rotation is indexed by visual indicia, tactile indicia, audible indicia, or any combination thereof, and wherein said indicia corresponds to a pre-determined longitudinal movement distance of the stylet.

6. The handle of claim 1 , wherein the advancement mechanism comprises an advancement member including at least one first detent in mechanical communication with the stylet and an anchor member including at least one second detent attached to the second handle member, the advancement mechanism configured such that a longitudinal movement of the advancement member relative to the anchor member will move the stylet longitudinally relative to the second handle member, and wherein the at least one first detent engages the at least one second detent when longitudinally distally advanced relative to the second handle member by the predetermined increment.

7. The handle of claim 6 , wherein the longitudinal movement is indexed by visual indicia, tactile indicia, audible indicia, or a combination thereof, and wherein said indicia corresponds to a known longitudinal movement distance of the stylet.

8. The handle of claim 6 , wherein at least one of the first detents or second detents comprises a plurality of detents that engages at least one of the other of the first detents or second detents.

9. The handle of claim 1 , further comprising a visual index indicating relative movement of the first and second handle members and indicating extension of the needle relative to the sheath.

10. The handle of claim 1 ,
wherein the needle includes
a tubular cannula body defining the needle lumen and
a distal needle end region, the distal end region comprising
a distal needle end opening at a distal end of the needle lumen; and
at least one generally longitudinal needle slot extending radially through at least a thickness portion of the cannula body and open to the needle lumen, where the needle slot includes at least one detent disposed within and across a width of the needle slot;

wherein each fiducial comprises
a generally columnar body including
a central fiducial portion slidably disposed in the needle lumen; and
at least one side protuberance projecting into the needle slot; and

wherein the stylet is configured to advance each fiducial past the at least one detent and out of the distal needle end opening.

11. The handle of claim 10 ,
wherein the advancement mechanism comprises a threaded rotatable advancement member in mechanical communication with the stylet and an anchor member attached to the second handle member, the advancement mechanism configured such that a predetermined degree of rotation of the advancement member relative to the anchor member will move the stylet longitudinally distally through the needle by a first of the predetermined increments.

12. The handle of claim 11 , wherein the rotation is indexed by visual indicia, tactile indicia, audible indicia, or a combination thereof, and wherein said indicia of rotation corresponds to a known longitudinal movement distance of the stylet.

13. The handle of claim 11 , wherein the advancement mechanism is configured such that moving the rotatable advancement member in one direction by the predetermined degree of rotation will advance the stylet distally by the first predetermined increment and will advance a distal-most of the plurality of fiducials past the at least one detent and out of the distal needle end opening.

14. The handle of claim 13 , further comprising visual indicia of a distance advanced distally by the stylet and of a number of one or more fiducials advanced past the detent and out of the distal needle end opening.

15. The handle of claim 11 , wherein the rotatable advancement member is generally cylindrically shaped.

16. The handle of claim 15 , the rotatable advancement member further comprising at least one lateral extension that provides increased rotational leverage.

17. A method of placing a fiducial into a patient body, the method comprising the steps of
providing the fiducial deployment system handle of claim 13 ;
directing the distal needle end through an endoscope to near a first target site in a patient body;
deploying a fiducial by rotating the rotatable advancement member by the predetermined degree of rotation, thereby pushing the fiducial past the at least one detent surface and into the first target site.

18. The method of claim 17 , further comprising the steps of:
withdrawing the needle proximally from the target site, but not entirely into the endoscope;
directing the needle to a second target site; and
repeating the deploying step to deploy another fiducial.

19. A fiducial deployment system comprising:
a flexible elongate needle sheath configured for passage through a working channel of an endoscope, the needle sheath including
a sheath lumen extending longitudinally through its length;

a flexible elongate needle extending slidably through the sheath lumen, the needle including
a tubular cannula body defining a needle lumen disposed through at least a lengthwise portion of the cannula body and
a distal needle end region, the distal end region comprising
a distal needle end opening at a distal end of the needle lumen; and
at least one generally longitudinal needle slot extending radially through at least a thickness portion of the cannula body and open to the needle lumen, where the needle slot includes at least one detent;

a plurality of at least three separate and independent fiducials, each including
a generally columnar body including
a central fiducial portion sl

Assignees

• Ducharme Richard W
• Surti Vihar C
• Mclawhorn Tyler E
• Skelton Eugene
• Bruggeman Martin J
• Cook Medical Technologies Llc

Inventors

• Ducharme Richard W
• Surti Vihar C
• Mclawhorn Tyler E
• Skelton Eugene
• Bruggeman Martin J

Classifications

• A61B2018/00273

  Anchoring means for temporary attachment of a device to tissue · CPC title

• A61B2019/5425

  Human Necessities · mapped topic

• A61B1/018

  for receiving instruments · CPC title

• A61B17/0401

  Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors (A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811) · CPC title

• A61B17/06166

  Sutures (suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M) · CPC title