Marker delivery device for tissue marker placement

• US 8,670,818 B2
• Filed: 12/30/2008
• Issued: 03/11/2014
• Est. Priority Date: 12/30/2008
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Ranpura, Himanshu, Van Liere, Chad C.
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): PARK, PATRICIA JOO YOUNG
• Application Number:
  US12/595,010
• Publication Number:
  US 20110028836A1
• Time in Patent Office: 1,897 Days
• Field of Search: 600/432
• US Class Current: 600/432
• 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

Abstract

A marker delivery device is configured for deploying a tissue marker. The marker delivery device includes a handle having a chamber, and a cannula. According to one aspect, the cannula has a flexible portion formed by a slot arrangement having of a plurality of spaced-apart substantially parallel peripheral slots extending through the side wall of the cannula to the lumen. A marker introducer rod is movably disposed in the lumen of the cannula for deploying the mark, and has a flexible region that corresponds to the flexible portion of the cannula. According to another aspect, a retraction mechanism is mounted to the handle and is configured to facilitate a complete retraction of both the cannula and the marker introducer rod into the chamber of the housing of the handle upon an actuation of the retraction mechanism.

Claims

1. A marker delivery device configured for deploying a tissue marker, comprising:

a handle having a chamber;

a cannula configured for holding the tissue marker for deployment;

a marker introducer rod movably disposed in the lumen of the cannula;

a deployment mechanism mounted to the handle and configured to displace the marker introducer rod for deploying the tissue marker upon an actuation of the deployment mechanism, and

a retraction mechanism mounted to the handle and configured to facilitate a complete retraction of both the cannula and the marker introducer rod into the chamber of the housing of the handle upon an actuation of the retraction mechanism, wherein the deployment mechanism includes a first shear member that has a first region of reduced cross section dimension configured to shear during retraction of the marker introducer rod to limit the marker delivery device to a single use for marker deployment.

2. The marker delivery device of claim 1, wherein the retraction mechanism includes a retraction trigger and a second shear member having a second region of reduced cross section dimension coupled to the retraction trigger, and configured such that the second region of reduced cross section dimension is sheared to separate the retraction trigger from the second shear member when the retraction trigger is actuated so as to prevent the cannula and the marker introducer rod from extending outside the chamber after the complete retraction of the cannula and the marker introducer rod into the chamber.

3. A marker delivery device configured for deploying a tissue marker, comprising:

a handle configured to be grasped by a user;

a cannula having a proximal end and a distal end, the proximal end being coupled to the handle; and

a marker introducer rod movably disposed in the lumen of the cannula to effect a deployment of the tissue marker from the distal end of the cannula, wherein the handle includes a housing having a front end and a back end, with a chamber having a longitudinal extent between the front end and the back end, and having a hole leading to the chamber for receiving the cannula, and further comprising;

an introducer rod guide block attached to the actuation end of the marker introducer rod, the introducer rod guide block being slidably disposed in the chamber of the housing;

a first shear member that has a first region of reduced cross section dimension configured to shear during retraction of the marker introducer rod;

a marker deployment trigger accessible at an exterior of the housing, the marker deployment trigger being linked to the introducer rod guide block by the first shear member, wherein an actuation of the marker deployment trigger causes the first shear member to displace the marker introducer rod to move the marker introducer rod along the lengthwise extent of the cannula to deploy the tissue marker from the lumen of the cannula;

a retraction trigger accessible at the exterior of the housing;

a second shear member having a second region of reduced cross section dimension coupled to the retraction trigger, and configured such that the second region of reduced cross section dimension is sheared to separate the retraction trigger from the second shear member when the retraction trigger is actuated;

a cannula guide block attached to the proximal end of the cannula, the cannula guide block being slidably disposed in the chamber of the housing, the retraction trigger being linked to the cannula guide block by the second shear member to hold the cannula guide block stationary relative to the housing of the handle; and

a spring located between the front end of the housing and the cannula guide block, the spring being in a compressed state prior to actuation of the retraction trigger to provide a preload on the cannula guide block.

4. The marker delivery device of claim 3, configured such that an actuation of the retraction trigger displaces the second shear member in a first direction and the spring decompresses to displace the cannula guide block in a second direction to shear the second shear member at the second region of reduced cross section dimension and to shear the first shear member at the first region of reduced cross section dimension to cause a complete retraction of both the cannula and the marker introducer rod into the chamber of the housing of the handle.

5. The marker delivery device of claim 3, configured such that an actuation of the retraction trigger moves the second region of reduced cross section dimension from a support position within a side wall of the housing to an exposed position in the chamber of the housing, resulting in a release of the spring from the compressed state to force the cannula guide block to move toward the back end of the housing to shear the second shear member at the second region of reduced cross section dimension to begin an initial retraction of the cannula, and wherein a continued decompression of the spring causes the cannula guide block to impact the introducer rod guide block to shear the first shear member at the first region of reduced cross section dimension, whereby beginning a simultaneous retraction of both the cannula and the marker introducer rod into the chamber of the housing of the handle.

6. The marker delivery device of claim 5, wherein the simultaneous retraction of both the cannula and the marker introducer rod into the handle terminates after both the cannula and the marker introducer rod are completely contained in the chamber of the housing of the handle.

7. The marker delivery device of claim 3, wherein a spacing device is positioned between the introducer rod guide block and the cannula guide block, the spacing device having a length along the lengthwise extent such that the cannula guide block is in operable contact with the introducer rod guide block when the introducer rod guide block is positioned in the marker deployed position, such that the first shear member and the second shear member are sheared simultaneously when the retraction trigger is actuated, resulting in a complete simultaneous retraction of both the cannula and the marker introducer rod into the chamber of the housing.

8. The marker delivery device of claim 3, further comprising a lock mechanism to lock the marker deployment trigger in a marker deployed position after the tissue marker has been deployed.

9. The marker delivery device of claim 3, wherein:

the marker deployment trigger includes a first lock member and the housing includes a second lock member, and

wherein the first lock member permanently engages the second lock member when the marker deployment trigger is positioned in the marker deployed position.

10. The marker delivery device of claim 9, wherein one of the first lock member and the second lock member is a lock channel and the other of the first lock member and the second lock member is a spring-loaded insert member that engages the lock channel lock when the marker deployment trigger is positioned in the marker deployed position.

11. A marker delivery device configured for deploying a tissue marker, comprising:

a handle configured to be grasped by a user, the handle including a housing having a front end and a back end, with a chamber located between the front end and the back end, and having a hole leading from the chamber to the exterior of the handle;

a cannula having a proximal end, a distal end, and a lumen extending along a lengthwise extent of the cannula between the proximal end and the distal end, the cannula being positioned in the handle such that the cannula retractably extends through the hole beyond the front end of the housing;

a marker introducer rod movably disposed in the lumen of the cannula to effect a deployment of the tissue marker from the distal end of the cannula, the marker introducer rod having an actuation end and a marker deployment end;

a deployment mechanism mounted to the housing, the deployment mechanism being coupled to the actuation end of the marker introducer rod, the deployment mechanism being configured to displace the marker introducer rod for deploying the tissue marker upon an actuation of the deployment mechanism;

a retraction mechanism mounted to the housing, the retraction mechanism being coupled to the proximal end of the cannula, the retraction mechanism being configured to facilitate a complete retraction of both the cannula and the marker introducer rod into the chamber of the housing of the handle upon an actuation of the retraction mechanism; and

a shear mechanism having a shear region of reduced cross section dimension, the shear mechanism configured to be manually displaced by a user and configured such that when manually displaced the shear region is exposed to a force exerted by the retraction mechanism to shear the shear mechanism at the shear region to enable the retraction.

12. The marker delivery device of claim 11, wherein the deployment mechanism includes:

an introducer rod guide block attached to the actuation end of the marker introducer rod, the introducer rod guide block being slidably disposed in the chamber of the housing;

a first shear member that has a first region of reduced cross section dimension configured to shear during retraction of the marker introducer rod; and

a marker deployment trigger accessible at an exterior of the housing, the marker deployment trigger being linked to the introducer rod guide block by the first shear member, wherein an actuation of the marker deployment trigger causes the first shear member to displace the marker introducer rod to move the marker introducer rod along the lengthwise extent of the cannula to deploy the tissue marker from the lumen of the cannula, and configured such that when the first shear member is sheared the marker deployment trigger is permanently disconnected from the introducer guide block.

13. The marker delivery device of claim 12, wherein:

the housing includes a trigger slot that extends through a side wall of the housing,

the marker deployment trigger being mounted to the housing for sliding movement along the trigger slot from an initial position to a marker deployed position,

the marker deployment trigger includes a first lock member and the housing includes a second lock member, and

the first lock member permanently engages the second lock member when the marker deployment trigger is positioned in the marker deployed position.

14. The marker delivery device of claim 13, wherein one of the first lock member and the second lock member is a lock channel and the other of the first lock member and the second lock member is a spring-loaded insert member that engages the lock channel lock when the marker deployment trigger is positioned in the marker deployed position.

15. The marker delivery device of claim 11, wherein the retraction mechanism includes:

a retraction trigger accessible at the exterior of the housing, the retraction trigger;

a second shear member;

a cannula guide block attached to the proximal end of the cannula, the cannula guide block being slidably disposed in the chamber of the housing, the retraction trigger being linked to the cannula guide block by the second shear member to hold the cannula guide block stationary relative to the housing of the handle;

the second shear member having a second region of reduced cross section dimension configured to shear during a retraction of the cannula guide block, and wherein when the second shear member is sheared the retraction trigger is permanently disconnected from the cannula guide block; and

a spring located between the front end of the housing and the cannula guide block, the spring being in a compressed state prior to actuation of the retraction trigger to provide a preload on the cannula guide block, and configured to decompress to initiate the retraction of the cannula guide block within the housing to shear the second shear member at the second region of reduced cross section dimension when the retraction trigger is actuated.

16. The marker delivery device of claim 15, wherein an actuation of the retraction trigger causes a complete retraction of both the cannula and the marker introducer rod into the chamber of the housing of the handle.

17. The marker delivery device of claim 15, configured such that an actuation of the retraction trigger moves the second region of reduced cross section dimension from a support position within a side wall of the housing to an exposed position in the chamber of the housing, resulting in a release of the spring from the compressed state to force the cannula guide block to move toward the back end of the housing to shear the second shear member at the second region of reduced cross section dimension to begin an initial retraction of the cannula, and wherein a continued decompression of the spring causes the cannula guide block to impact the introducer rod guide block to shear the first shear member at the first region of reduced cross section dimension, whereby beginning a simultaneous retraction of both the cannula and the marker introducer rod into the chamber of the housing of the handle.

18. The marker delivery device of claim 17, wherein the simultaneous retraction of both the cannula and the marker introducer rod into the handle terminates after both the cannula and the marker introducer rod are completely contained in the chamber of the housing of the handle.

19. The marker delivery device of claim 15, wherein a spacing device is positioned between the introducer rod guide block and the cannula guide block, the spacing device having a length along the lengthwise extent such that the cannula guide block is in operable contact with the introducer rod guide block when the introducer rod guide block is positioned in the marker deployed position, such that the first shear member and the second shear member are sheared simultaneously when the retraction trigger is actuated, resulting in a complete simultaneous retraction of both the cannula and the marker introducer rod into the chamber of the housing.

20. The marker delivery device of claim 11, wherein:

the cannula has a flexible portion formed by a slot arrangement having of a plurality of peripheral slots extending through a side wall of the cannula to the lumen, the plurality of peripheral slots being spaced apart to be substantially parallel along the lengthwise extent of the cannula to facilitate a flexure at the flexible portion of the cannula; and

the marker introducer rod has a flexible region that corresponds to the flexible portion of the cannula.

21. The marker delivery device of claim 20, wherein the flexible portion of the cannula is located closer to the distal end of the cannula than to the proximal end of the cannula.

22. The marker delivery device of claim 20, wherein the plurality of peripheral slots are configured to facilitate the flexure at the flexible portion of the cannula along a single predetermined plane.

23. The marker delivery device of claim 20, wherein the plurality of peripheral slots include a first set of peripheral slots having a first circumferential extent and a second set of peripheral slots having a second circumferential extent.

24. The marker delivery device of claim 23, wherein the first circumferential extent is circumferentially alternatingly staggered with respect to the second circumferential extent.

25. The marker delivery device of claim 20, wherein the side wall of the cannula includes an axial slot linking at least a portion of the plurality of peripheral slots.

26. The marker delivery device of claim 20, wherein the cannula is formed from a metallic material, and at least the flexible region of the marker introducer rod is formed as a flexible metallic element.

27. The marker delivery device of claim 26, wherein the cannula is formed from a metallic material, and at least the flexible region of the marker introducer rod is formed as a flexible plastic element.

28. The marker delivery device of claim 11, wherein the retraction mechanism includes a first retraction mechanism configured for retracting the marker introducer rod and a second retraction mechanism configured for retracting the cannula, wherein an initial retraction of the introducer rod occurs before a retraction of the cannula.

29. The marker delivery device of claim 11, wherein the retraction mechanism includes a first retraction mechanism configured for retracting the marker introducer rod and a second retraction mechanism configured for retracting the cannula, wherein a complete retraction of the introducer rod occurs before a retraction of the cannula.

30. The marker delivery device of claim 11, wherein the retraction mechanism includes:

an introducer rod guide block attached to the actuation end of the marker introducer rod, the introducer rod guide block being slidably disposed in the chamber of the housing;

a cannula guide block attached to the proximal end of the cannula, the cannula guide block being slidably disposed in the chamber of the housing;

a first spring engagingly located between the introducer guide block and the cannula guide block; and

a marker deployment trigger accessible at an exterior of the housing, the marker deployment trigger being linked to the introducer rod guide block by a first shear member of the shear mechanism, and configured such that an actuation of the marker deployment trigger to a first position causes the first shear member to displace the marker introducer rod to move the marker introducer rod along the lengthwise extent of the cannula to deploy the tissue marker from the lumen of the cannula and to simultaneously compress the first spring, and a further actuation of the marker deployment trigger to a second position different from the first position releases the first spring for decompression to shear the first shear member to retract the marker introducer rod into the chamber of the housing of the handle.

31. The marker delivery device of claim 30, wherein the decompression of the first spring results in a shearing of the first shear member, and the complete retraction of the marker introducer rod into the chamber of the housing of the handle.

32. The marker delivery device of claim 30, further including:

a retraction trigger mounted to the housing, the retraction trigger being coupled to the cannula guide block; and

a second spring engagingly located between the front end of the housing and the cannula guide block, the second spring being in a compressed state prior to actuation of the retraction trigger to provide a preload on the cannula guide block,

wherein an actuation of the retraction trigger results in a decompression of the second spring causing a complete retraction of the cannula into the chamber of the housing of the handle.