Expandable brachytherapy apparatus and methods for using them

• US 7,862,498 B2
• Filed: 10/06/2007
• Issued: 01/04/2011
• Est. Priority Date: 10/08/2006
• Status: Active Grant

• Current Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Original Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Inventors: Nguyen, Than, Nguyen, Tommy G., Sutton, Doug S.
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): DORNA, CARRIE R
• Application Number:
  US11/868,483
• Publication Number:
  US 20080091055A1
• Time in Patent Office: 1,186 Days
• Field of Search: 600 1- 8, 606191-200
• US Class Current: 600/7
• CPC Class Codes: A61N 2005/1018 with multiple channels for guiding radioactive sources
• CPC Class Codes: A61N 5/1014 Intracavitary radiation therapy
• CPC Class Codes: A61N 5/1015 Treatment of resected cavities created by surgery, e.g. lumpectomy

Abstract

Apparatus for delivering brachytherapy to a target tissue region includes an elongate body including a proximal end, a distal end sized for introduction into a tissue tract and carrying a plurality of elongate members including pathways for receiving a source of radiation. The elongate members are movable between collapsed and expanded configurations. During use, a tract is created through tissue, and the elongate body carrying the elongate members is advanced through the tract into a target location with the elongate members in the collapsed configuration. The elongate members are directed to the expanded configuration at the target location, and radiation is delivered to treat tissue at the target location, e.g., by introducing one or more radiation sources along the pathways. The apparatus may include features to prevent overexpansion of the elongate members and/or to facilitate rapid collapse of the elongate members.

Claims

1. A brachytherapy treatment apparatus, comprising:

an elongate core member comprising a proximal end and a distal end configured for introduction into a tract through tissue, the proximal and distal ends defining a longitudinal axis;

a distal hub coupled to the distal end of the core member;

a proximal hub on the proximal end of the core member and movable axially relative to the distal hub; and

a plurality of elongate members coupled to the proximal and distal hubs and extending between the proximal and distal ends of the core member, the elongate members movable from a collapsed configuration extending substantially parallel to the longitudinal axis for introduction through a tissue tract to a target location, and an expanded configuration when the proximal hub is directed distally relative to the distal hub, the elongate members comprising pathways for receiving a source of radiation therealong,

wherein the core member comprises first and second telescoping tubes, the first tube coupled to one of the proximal hub and the distal hub and the second tube coupled to the other of the proximal hub and the distal hub such that rotation of the first tube relative to the second tube causes the proximal hub to move distally to direct the elongate members towards the expanded configuration, and

wherein the first and second tubes are telescopingly coupled such that the first tube telescopes at least partially into the second tube and external first threads on the first tube mate with internal second threads on the second tube, the second tube including an unthreaded region located adjacent the internal second threads and having a diameter larger than an outer diameter of the external first threads, such that, when the first tube is rotated sufficiently to direct the elongate members to the expanded configuration, the external first threads pass entirely through the internal second threads and enter the unthreaded region of the second tube to disengage the threads, thereby limiting further distal movement of the proximal hub.

2. The apparatus of claim 1, wherein at least one of the first and second tubes comprises a stop to prevent further distal movement of the first tube relative to the second tube when the elongate members are directed to the expanded configuration and the threads are disengaged, thereby preventing overexpansion of the elongate members.

3. The apparatus of claim 1, wherein the proximal hub and the first tube include mating features that couple rotation of the first tube to axial movement of the proximal hub.

4. The apparatus of claim 1, further comprising a release mechanism on at least one of the first tube and the proximal hub for disengaging the proximal hub from the first tube to allow rapid collapse of the elongate members from the expanded configuration.

5. The apparatus of claim 4, wherein the release mechanism comprises a retaining ring disposed around the first tube to prevent proximal movement of the proximal hub relative to the first tube unless a predetermined axial force is applied to at least one of the proximal hub and the first tube.

6. The apparatus of claim 1, wherein the distal hub is substantially radiolucent.

7. The apparatus of claim 1, further comprising a release mechanism on at least one of the core member and the proximal hub for disengaging the proximal hub to allow rapid collapse of the elongate members from the expanded configuration.

8. The apparatus of claim 1, further comprising a plurality of supports for supporting respective elongate members when the elongate members are directed to the expanded configuration.

9. The apparatus of claim 8, wherein the supports comprise first ends secured to the proximal hub and second ends disposed adjacent to distal ends of the elongate members.

10. The apparatus of claim 9, wherein the first ends of the supports are received within respective grooves within the proximal hub.

11. The apparatus of claim 9, wherein the first ends of the supports are secured to the proximal hub by a locking ring.

12. The apparatus of claim 8, wherein the elongate members comprise tubular members and wherein the supports extend along outer surfaces of the tubular members.

13. The apparatus of claim 12, wherein the supports are attached to the outer surfaces using shrink tubing.

14. The apparatus of claim 1, wherein the core member comprises a pathway for receiving a source of radiation.

15. The apparatus of claim 1, further comprising a plurality of marker devices removably receivable along the pathways of respective elongate members.

16. The apparatus of claim 15, wherein the marker devices comprise radiopaque material.

17. The apparatus of claim 15, wherein the pathways comprise lumens extending between proximal and distal ends of the elongate members, and wherein the marker devices are receivable within the lumens such that the marker devices extend through the lumens to the distal ends of the elongate members.

18. The apparatus of claim 17, wherein the marker devices comprise end caps for engaging the proximal ends of the elongate members when the marker devices are received within the lumens to substantially seal the lumens.

19. The apparatus of claim 1, further comprising a source of radiation introduceable along the pathways for delivering radiation to the target location.

20. The apparatus of claim 1, wherein the elongate members comprise a three dimensional array in the expanded configuration.

21. The apparatus of claim 20, wherein the three dimensional array provides multiple layers of radiation sources when one or more sources of radiation are introduced into the elongate members.

22. The apparatus of claim 1, further comprising an expansion tool removably connectable to the core member for directing the proximal hub axially relative to the distal hub.

23. The apparatus of claim 1, wherein the mating threads provide an audible click when the external threads enter the unthreaded region to provide confirmation that the elongate members are fully expanded to the expanded configuration.

24. The apparatus of claim 1, wherein the mating threads are configured such that, when the first tube is rotated to collapse the elongate members, the external threads reengage the internal threads to direct the proximal hub proximally.

25. The apparatus of claim 1, wherein the first tube includes an unthreaded region adjacent the external first threads having an outer diameter smaller than the internal second threads such that, when the external first threads enter the unthreaded region of the second tube, the unthreaded region of the first tube is disposed within the internal second threads.

26. The apparatus of claim 1, wherein the first tube is configured to spin freely within the second tube when the first and second threads are disengaging without causing further axial movement of the first tube to provide tactile feedback that the elongate members have been fully expanded to the expanded configuration.

27. A brachytherapy treatment apparatus, comprising:

an elongate core member comprising a proximal end and a distal end configured for introduction into a tract through tissue, the proximal and distal ends defining a longitudinal axis, the core member comprising first and second tubes telescopingly coupled relative to one another such that the first tube telescopes at least partially into the second tube, the first tube comprising external first threads that mate with internal second threads on the second tube;

a distal hub coupled to one of the first tube and the second tube;

a proximal hub coupled to the other of the first tube and the second tube such that rotation of the first tube relative to the second tube causes the proximal hub to move axially relative to the distal hub; and

a plurality of elongate members coupled to the proximal and distal hubs and extending between the proximal and distal ends of the core member, the elongate members movable from a collapsed configuration extending substantially parallel to the longitudinal axis for introduction through a tissue tract to a target location, and an expanded configuration when the proximal hub is directed distally relative to the distal hub, the elongate members comprising pathways for receiving a source of radiation therealong,

wherein the core member comprises features that limit distal movement of the proximal hub to prevent overexpansion of the elongate members in the expanded configuration, the features comprising an unthreaded first region on the first tube adjacent the external first threads and an unthreaded second region within the second tube adjacent the internal second threads, the unthreaded first region having an outer diameter smaller than an inner diameter of the internal second threads, the unthreaded second region having a length longer than the external first threads and a diameter larger than an outer diameter of the external first threads such that, when the first tube is rotated sufficiently to direct the elongate members to the expanded configuration, the external first threads on the first tube pass entirely through the internal second threads and enter the unthreaded second region and the unthreaded first region is disposed within the internal second threads, thereby disengaging the first and second threads and limiting further distal movement of the proximal hub.

28. The apparatus of claim 27, wherein the features further comprise a stop to prevent further distal movement of the first tube relative to the second tube when the elongate members are directed to the expanded configuration and the threads are disengaged.

29. The apparatus of claim 27, wherein the mating threads provide an audible click when the external threads enter the unthreaded region to provide confirmation that the elongate members are fully expanded to the expanded configuration.

30. The apparatus of claim 27, wherein the mating threads are configured such that, when the first tube is rotated to collapse the elongate members, the external threads reengage the internal threads to direct the proximal hub proximally.

31. The apparatus of claim 27, further comprising a release mechanism on at least one of the first tube and the proximal hub for disengaging the proximal hub from the first tube to allow rapid collapse of the elongate members from the expanded configuration.

32. The apparatus of claim 27, wherein the core member comprises a pathway for receiving a source of radiation.