Endoscopic ultrasound fine needle fiducial system

Patent metadata

Field	Value
Publication number	US-10485583-B2
Application number	US-201615284683-A
Country	US
Kind code	B2
Filing date	Oct 4, 2016
Priority date	Oct 7, 2015
Publication date	Nov 26, 2019
Grant date	Nov 26, 2019

Abstract

Methods, apparatuses and systems are described for implanting a plurality of fiducial markers into a tissue. Systems include a needle, a stylet sized to slide within a lumen of the needle, and a multi-stop stylet spacer having stopping features configured to engage with the stylet to stop the distal end of the stylet at one or more predetermined distances from the distal end of the needle. Methods for implanting a plurality of fiducial markers into a tissue are described and include inserting a needle preloaded with fiducial markers into a tissue, adjusting a multi-stop stylet spacer from a safety position to a first deployment position, deploying a first fiducial marker into the tissue, adjusting the stylet spacer from the first deployment position to a second deployment position, and deploying a second fiducial marker into the tissue.

First claim

The invention claimed is:

1. A device for implanting a plurality of fiducial markers into a tissue, comprising:
a needle having a proximal end, a distal end, and a lumen extending therebetween;
a stylet having a proximal end, a distal end, and a proximal hub attached to the proximal end, wherein the distal end is sized to slide within the lumen of the needle; and
a multi-stop stylet spacer having a plurality of stopping features arranged in a stair-stepped configuration and configured to engage with the proximal hub of the stylet and stop the distal end of the stylet at a plurality of predetermined distances from the distal end of the needle, wherein:
the multi-stop stylet spacer is adjustable between a plurality of positions by translating, relative to the stylet, the multi-stop stylet spacer in a plane orthogonal to a longitudinal axis of the stylet;
in a first position, a first stopping feature engages with the proximal hub and prevents distal movement of the stylet;
in a second position, the first stopping feature disengages from the proximal hub and allows distal movement of the stylet until a second stopping feature engages with the proximal hub and prevents distal movement of the stylet, wherein the multi-stop stylet spacer translates from the first position to the second position along the plane orthogonal to the longitudinal axis of the stylet; and
in a third position, the second stopping feature disengages from the proximal hub and allows distal movement of the stylet until a third stopping feature engages with the proximal hub and prevents distal movement of the stylet, wherein the multi-stop stylet spacer translates from the second position to the third position along the plane orthogonal to the longitudinal axis of the stylet.

2. The device of claim 1 , further comprising a plurality of fiducial markers housed within the lumen of the needle, wherein:
in the first position the first stopping feature prevents deployment of any of the plurality of fiducial markers from the distal end of the needle; and
in the second position the second stopping feature permits the deployment of a first of the plurality fiducial markers while preventing the deployment of a second of the plurality of fiducial markers.

3. The device of claim 1 , wherein the plurality of predetermined distances are based on a number and a size of a plurality of fiducial markers housed within the lumen of the needle.

4. The device of claim 1 , further comprising a plurality of fiducial markers housed within the lumen of the needle separated by at least one fiducial marker spacer.

5. The device of claim 1 , further comprising a fiducial marker retention member coupled with the distal end of the needle.

6. The device of claim 5 , wherein the fiducial marker retention member comprises bone wax.

7. The device of claim 5 , wherein the fiducial marker retention member comprises a cap configured to fit over the distal end of the needle.

8. The device of claim 5 , wherein the fiducial marker retention member comprises one or more detents disposed within the lumen of the needle.

9. The device of claim 1 , wherein the stylet is tapered such that the distal end has a smaller diameter than the proximal end.

10. A system for implanting a plurality of fiducial markers into a tissue, comprising:
a handle member assembly having a proximal end, a distal end, and a lumen extending therebetween;
a sheath having a proximal end, a distal end, and a lumen extending therebetween, the proximal end of the sheath being coupled with the distal end of the handle member assembly forming a continuous lumen from the proximal end of the handle member to the distal end of the sheath;
a needle having a proximal end, a distal end, and a lumen extending therebetween and being sized to advance through the continuous lumen of the handle member assembly and the sheath;
a plurality of fiducial markers housed within the lumen of the needle;
a stylet having a proximal end, a distal end, and a proximal hub attached to the proximal end and sized to advance through the lumen of the needle; and
a multi-stop stylet spacer having a plurality of stopping features arranged in a stair-stepped configuration configured to engage with the proximal hub of the stylet and controllably deploy the plurality of fiducial markers from the distal end of the needle, wherein:
the multi-stop stylet spacer is adjustable between a plurality of positions by translating, relative to the stylet, the multi-stop stylet spacer in a plane orthogonal to a longitudinal axis of the stylet;
in a first position, a first stopping feature engages with the proximal hub and prevents distal movement of the stylet;
in a second position, the first stopping feature disengages from the proximal hub and allows distal movement of the stylet until a second stopping feature engages with the proximal hub and prevents distal movement of the stylet, wherein the multi-stop stylet spacer translates from the first position to the second position along the plane orthogonal to the longitudinal axis of the stylet; and
in a third position, the second stopping feature disengages from the proximal hub and allows distal movement of the stylet until a third stopping feature engages with the proximal hub and prevents distal movement of the stylet, wherein the multi-stop stylet spacer translates from the second position to the third position along the plane orthogonal to the longitudinal axis of the stylet.

11. The system of claim 10 , wherein a first of the plurality of stopping features engages with the stylet to prevent the stylet from deploying any of the plurality of fiducial markers from the distal end of the needle.

12. The system of claim 11 , wherein a second of the plurality of stopping features engages with the stylet to permit the stylet to deploy a first fiducial marker from the distal end of the needle, and wherein a third of the plurality of stopping features engages with the stylet to permit the stylet to deploy a second fiducial marker from the distal end of the needle.

13. The system of claim 10 , wherein the multi-stop stylet spacer is adjustable between three positions, wherein:
in the first position the proximal end of the stylet engages the first stopping feature to stop the distal end of the stylet to prevent any of the plurality of fiducial markers from being deployed from the distal end of the needle;
in the second position the proximal end of the stylet engages the second stopping feature to stop the distal end of the stylet to permit the deployment of a first of the plurality fiducial markers while preventing the deployment of a second of the plurality of fiducial markers; and
in the third position the proximal end of the stylet engages the third stopping feature to stop the distal end of the stylet to permit the deployment of the second of the plurality of fiducial markers.

14. The system of claim 10 , further comprising at least one fiducial marker spacer disposed between at least two of the plurality of fiducial markers.

Assignees

• Covidien Lp

Inventors

• Campbell Eugene
• Mcweeney John O
• Tinkham Brian
• Tully Stephen J

Classifications

• A61B2090/3987

  Applicators for implanting markers · CPC title

• A61B2090/3925

  ultrasonic · CPC title

• A61B2090/0811

  for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument · CPC title

• A61B2090/0807

  Indication means · CPC title

• A61B90/39

  Markers, e.g. radio-opaque or breast lesions markers · CPC title