Expandable brachytherapy apparatus and methods for using them

• US 8,771,161 B2
• Filed: 12/18/2009
• Issued: 07/08/2014
• 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: Sutton, Doug S., Hermann, George D.
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): Dorna, Carrie R
• Application Number:
  US12/642,626
• Publication Number:
  US 20100099939A1
• Time in Patent Office: 1,663 Days
• Field of Search: 600 1- 8, 604 19- 21, 604/27, 604/28, 604/36, 604/48, 604/57, 604/93.01, 604/96.01, 604/103.03, 604506-510
• 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 body comprising a proximal end and a distal end configured for introduction into a tract through tissue to a target location within a patient'"'"'s body;

a plurality of elongate members comprising a distal portion adjacent the distal end and a proximal portion configured to extend from the patient'"'"'s body when the distal portion is introduced into the target location, the elongate members comprising lumens extending from openings in the proximal portion to the distal portion for receiving a source of radiation therealong, the distal portion of the elongate members being movable from a collapsed configuration for introduction through a tissue tract to a target location, and an expanded configuration; and

a plurality of marker devices removably receivable into the openings and along the lumens of respective elongate members, each marker device comprising an elongate solid cable,

wherein the marker devices are receivable within the lumens such that the marker devices extend through the lumens to the distal portion of the elongate members, and

wherein the marker devices comprise end caps for engaging the openings in the elongate members when the marker devices are received within the lumens to substantially seal the lumens.

2. The apparatus of claim 1, wherein the marker devices comprise radiopaque material.

3. The apparatus of claim 1, wherein the marker devices have sufficient strength to support the elongate members.

4. The apparatus of claim 1, wherein the marker devices include distal ends that extend into the distal portion when the marker devices are fully received within the respective lumen, and wherein the marker devices include one or more markers on the distal ends thereof.

5. The apparatus of claim 4, wherein the markers are radiopaque markers to enhance radiopacity of the distal ends.

6. The apparatus of claim 1, wherein the marker devices provide relatively strong yet flexible support when received along the lumens of the elongate members to prevent kinking or other deformation or damage to the elongate members between treatments.

7. The apparatus of claim 1, further comprising an expansion tool adjacent the proximal portion and coupled to the elongate body for directing the elongate members between the collapsed configuration and the expanded configuration.

8. A brachytherapy treatment apparatus, comprising:

an elongate body comprising a proximal end and a distal end configured for introduction into a tract through tissue to a target location within a patient'"'"'s body;

a plurality of tubular members comprising a distal portion carried by the elongate body and a proximal portion configured to extend from the patient'"'"'s body when the distal portion is introduced into the target location, the tubular members comprising lumens extending between openings in the proximal portion to the distal portion for receiving a source of radiation therealong; and

a plurality of devices removably receivable into the openings and along the lumens of respective tubular members, each device comprising an end cap for engaging the opening of the respective tubular member when the device is received within the lumen of the tubular member to substantially seal the lumen.

9. The apparatus of claim 8, wherein the devices comprise radiopaque material.

10. The apparatus of claim 8, wherein the devices are receivable within the lumens such that the devices extend through the lumens to the distal portion.

11. The apparatus of claim 8, wherein the devices have sufficient strength to support the tubular members.

12. The apparatus of claim 8, wherein the devices provide relatively strong yet flexible support when inserted into the tubular members to prevent kinking or other deformation or damage to the tubular members between treatments.

13. The apparatus of claim 8, wherein the distal portion is movable from a collapsed configuration for introduction through a tissue tract to a target location, and an expanded configuration.

14. The apparatus of claim 8, wherein the devices include one or more markers on distal ends thereof.

15. The apparatus of claim 14, wherein the markers are radiopaque markers to enhance radiopacity of the distal ends.

16. 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 to a target location, 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;

a plurality of tubular members coupled to the proximal and distal hubs and comprising a distal portion extending between the proximal and distal ends of the core member and a proximal portion extending proximally from the proximal hub and configured to extend from the patient'"'"'s body when the distal portion is introduced into the target location, the distal portion of the tubular 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 tubular members comprising lumens extending from openings in the proximal portion to the distal portion for receiving a source of radiation therealong; and

a plurality of devices removably receivable along the lumens of respective tubular members, each device comprising an elongate body including a distal end sized for introduced into the opening and lumen of a respective tubular member, and an end cap on a proximal end of the elongate body that is receivable over the proximal end of the respective tubular member when the device is received within the lumen of the tubular member to substantially seal the lumen.

17. The apparatus of claim 16, wherein the devices include one or more markers on the distal ends thereof.

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

19. The apparatus of claim 18, wherein the devices comprise radiopaque markers to enhance radiopacity of distal ends of the tubular members.

20. The apparatus of claim 16, wherein the devices are receivable within the lumens such that the devices extend through the lumens to the distal portion of the tubular members.

21. The apparatus of claim 16, wherein the devices have sufficient strength to support the tubular members.

22. The apparatus of claim 16, wherein the devices provide relatively strong yet flexible support when inserted into the tubular members to prevent kinking or other deformation or damage to the tubular members between treatments.

23. The apparatus of claim 16, further comprising an expansion tool adjacent the proximal portion and coupled to the core member for moving the proximal hub axially relative to the distal hub to direct the elongate members between the collapsed configuration and the expanded configuration.

24. A brachytherapy treatment apparatus, comprising:

an elongate body comprising a lumen extending from an opening in a proximal end of the elongate body to a closed distal end of the elongate body for receiving a source of radiation therein, the elongate body sized for introduction into a tract through tissue to a target location within a patient'"'"'s body;

a plurality of tubular members comprising a distal portion adjacent the distal end of the elongate body and a proximal portion configured to extend from the patient'"'"'s body when the distal portion is introduced into the target location, the distal portion of the tubular members movable from a collapsed configuration for introduction through a tissue tract to a target location, and an expanded configuration for contacting surrounding tissue at the target location, the tubular members comprising lumens extending from openings in the proximal portion to closed ends in the distal portion for receiving a source of radiation; and

a plurality of devices removably receivable into the openings and along the lumens of respective tubular members and the lumen of the elongate body, each device comprising an end cap for engaging the opening of the respective tubular member when the device is received within the lumen of the tubular member to substantially seal the lumen.

25. The apparatus of claim 24, further comprising an expansion tool adjacent the proximal portion and coupled to the elongate body for directing the tubular members between the collapsed configuration and the expanded configuration.