Expandable brachytherapy apparatus and methods for using them

• US 8,517,907 B2
• Filed: 11/24/2008
• Issued: 08/27/2013
• Est. Priority Date: 12/16/2007
• Status: Active Grant

• Current Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Original Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Inventors: Chi Sing, Eduardo, Nguyen, Tommy G., Hermann, George D., Nguyen, Than, Sutton, Doug S.
• Primary Examiner(s): Matthews, Christine
• Assistant Examiner(s): LANNU, JOSHUA DARYL DEANON
• Application Number:
  US12/277,286
• Publication Number:
  US 20090156882A1
• Time in Patent Office: 1,737 Days
• Field of Search: 600/7, 600/1, 600/3, 604/508, 604/509, 604/510, 604/107, 604/108, 604/109, 604/104, 604/105, 604/106
• US Class Current: 600/7
• CPC Class Codes: A61N 2005/1018 with multiple channels for guiding radioactive sources
• 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.

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, at least one of the proximal hub and the distal hub movable axially relative to the other of the proximal hub and the distal hub;

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;

tubular extensions extending proximally from the proximal hub and communicating with respective pathways for directing a source of radiation into the elongate members; and

a release mechanism distal to proximal ends of the tubular extensions on at least one of the proximal hub and the core member adjacent the proximal hub for irreversibly disengaging the proximal hub from the core member to allow rapid collapse of the elongate members from the expanded configuration.

2. The apparatus of claim 1, wherein the core member comprises first and second telescoping tubes, the first tube coupled to the proximal hub and the second tube coupled to 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.

3. The apparatus of claim 2, wherein the first and second tubes are telescopingly coupled by mating threads, and wherein the threads are disengaged when the first tube is rotated sufficiently to direct the elongate members to the expanded configuration, thereby limiting further distal movement of the proximal hub.

4. The apparatus of claim 3, 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, thereby preventing overexpansion of the elongate members.

5. The apparatus of claim 2, wherein the release mechanism comprises features on one of the proximal hub and the first tube that are disengaged upon application of a desired axial force to disengage the proximal hub and allow the proximal hub to be pulled proximally without rotation to rapidly collapse the elongate members from the expanded configuration towards the collapsed configuration.

6. The apparatus of claim 2, 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.

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

10. A system for brachytherapy treatment of tissue adjacent a cavity within a body, comprising the apparatus of claim 1, the system further comprising:

a prep catheter comprising a proximal end, a distal end sized for introduction through the tissue tract into a body cavity, and an expandable member on the prep catheter distal end for dilating tissue surrounding the body cavity before introducing the apparatus therein.

12. A system for brachytherapy treatment of tissue adjacent a cavity within a body, comprising the apparatus of claim 1, the system further comprising:

an introducer sheath comprising a proximal end, a distal end sized for introduction through a tissue tract into a body cavity, and defining a lumen therebetween sized for receiving the apparatus therein in the collapsed configuration, the sheath including a slit extending at least partially between the sheath proximal and distal ends to facilitate removal of the sheath from around the apparatus.

13. The system of claim 12, further comprising a trocar received through the lumen of the introducer sheath to facilitate advancing the sheath directly through tissue, the trocar being removable from the sheath after introducing the sheath into the cavity.

8. A method for brachytherapy treatment of tissue within a body, comprising:

creating a tract through tissue to a target location adjacent to a cavity;

advancing a distal portion of an elongate body carrying a plurality of elongate members through the tract into the target location with the elongate members in a collapsed configuration wherein the elongate body comprises a proximal hub that is movable axially relative to the elongate body when an expansion tool is rotated for directing the elongate members to an expanded configuration;

directing the elongate members to the expanded configuration at the target location to position the elongate members away from a central axis;

delivering radiation to the target location to treat tissue at the target location, wherein directing the elongate members to the expanded configuration comprises rotating the expansion tool in a first direction, and wherein, upon directing the elongate members to the expanded configuration, threads on the distal portion are disengaged such that further rotation of the expansion tool in the first direction no longer expands the elongate members; and

disengaging the proximal hub from the elongate body, and pulling the proximal hub without rotation to collapse the elongate members.

9. The method of claim 8, wherein a stop is contacted after the expansion tool is rotated to direct the elongate members to the expanded configuration to prevent further expansion of the elongate members.

11. A method for brachytherapy treatment of tissue, comprising:

creating a tract through tissue to a target location adjacent to a cavity;

introducing a distal end of a prep catheter through the tract into the cavity;

expanding an expandable member on the distal end of the prep catheter within the cavity;

removing the prep catheter;

advancing a distal portion of an elongate body carrying a plurality of elongate members through the tract into the target location with the elongate members in a collapsed configuration;

rotating an expansion tool in a first direction to direct the elongate members to an expanded configuration at the target location to position the elongate members away from a central axis, wherein, upon reaching the expanded configuration, threads on the distal portion are disengaged such that further rotation of the expansion tool in the first direction no longer expands the elongate members; and

delivering radiation to the target location to treat tissue at the target location.

14. A brachytherapy treatment apparatus, comprising:

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

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

a proximal hub on the proximal end of the core member, at least one of the proximal hub and the distal hub movable axially relative to the other of the proximal hub and the distal hub;

a guide member on the core member disposed between the proximal and distal hubs; 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 comprising pathways for receiving a source of radiation therealong, the elongate members movable between a collapsed configuration wherein intermediate regions of the elongate members are received in respective recesses in the guide member for introduction through a tissue tract to a target location, and an expanded configuration when one of the proximal and distal hubs is directed towards the other of the proximal and distal hubs, the intermediate regions moving radially out of the respective recesses as the elongate members are directed towards the expanded configuration.

15. The apparatus of claim 14, wherein the elongate members are received in the recesses in the collapsed configuration such that the elongate members do not extend substantially parallel to the longitudinal axis.

16. The apparatus of claim 14, wherein the elongate members are received in the recesses in the collapsed configuration such that the elongate members are arched in the collapsed configuration.

17. The apparatus of claim 14, wherein the recesses comprise side walls that prevent substantial lateral motion of the elongate members while the intermediate regions are received in the recesses.

18. The apparatus of claim 14, wherein the recesses comprise grooves that extend substantially parallel to the longitudinal axis.

19. A method for brachytherapy treatment of tissue within a body, comprising:

creating a tract through tissue to a target location adjacent to a cavity;

advancing a distal portion of an elongate body through the tract into the target location with the distal portion in a collapsed configuration, the distal portion comprising a plurality of elongate members disposed around an elongate core member with intermediate regions of the elongate members being received in respective recesses in a guide member between proximal and distal hubs on the core member at the distal portion in the collapsed configuration;

directing the distal portion to an expanded configuration at the target location wherein the elongate members expand away from a central axis and the intermediate regions exit the respective recesses; and

delivering radiation to the target location via the distal portion to treat tissue at the target location.

20. A brachytherapy treatment apparatus, comprising:

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

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

a proximal hub on the proximal end of the core member, at least one of the proximal hub and the distal hub movable axially relative to the other of the proximal hub and the distal hub;

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 comprising pathways for receiving a source of radiation therealong, the elongate members movable between a collapsed configuration for introduction through a tissue tract to a target location, and an expanded configuration when one of the proximal and distal hubs is directed towards the other of the proximal and distal hubs; and

a guide member on the core member disposed between the proximal and distal ends, the guide member having a size such that intermediate regions of the elongate members contact the guide member in the collapsed configuration such that the elongate members do not extend substantially parallel to the longitudinal axis.

21. The apparatus of claim 20, wherein the elongate members are received in respective recesses in the guide member in the collapsed configuration.

22. The apparatus of claim 20, wherein the elongate members are arched in the collapsed configuration.

23. A method for brachytherapy treatment of tissue within a body, comprising:

creating a tract through tissue to a target location adjacent to a cavity;

advancing a distal portion of an elongate body through the tract into the target location with the distal portion in a collapsed configuration, the distal portion comprising a plurality of elongate members disposed around an elongate core member with intermediate regions of the elongate members being received in respective recesses in a guide member on the core member in the collapsed configuration;

directing the distal portion to an expanded configuration at the target location wherein the elongate members expand away from a central axis and the intermediate regions exit the respective recesses; and

delivering radiation to the target location via the distal portion to treat tissue at the target location,

wherein the elongate members are arched in the collapsed configuration, the elongate members arching further in the expanded configuration.