Expandable brachytherapy device

• US 7,662,082 B2
• Filed: 11/04/2005
• Issued: 02/16/2010
• Est. Priority Date: 11/05/2004
• Status: Active Grant

• Current Assignee: Theragenics Corporation (Juniper Investment Co. LLC)
• Original Assignee: Theragenics Corporation (Juniper Investment Co. LLC)
• Inventors: Griffith, Nathan Christopher, Govil, Amit Prakash, Bergman, Joshua J., Stephens, David Wesley, Millage, Kyle Kevin, White, Jack C.
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): MATTHEWS, CHRISTINE HOPKINS
• Application Number:
  US11/266,994
• Publication Number:
  US 20060100475A1
• Time in Patent Office: 1,565 Days
• Field of Search: 600 1- 8, 600/14, 600/19, 600/27, 600/96.01, 600/99.01, 600/101.01, 600/102.03, 600/133.11, 600/103.12, 600/433, 604/35, 604/164.03, 604/164.1, 604/165.01, 604/165.02, 604/177, 604/264, 604/20, 604/21, 604/28
• US Class Current: 600/3
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61N 2005/1008 Apparatus for temporary insertion of sources, e.g. afterloaders
• CPC Class Codes: A61N 2005/1018 with multiple channels for guiding radioactive sources
• CPC Class Codes: A61N 2005/1024 Seeds
• CPC Class Codes: A61N 5/1007 Arrangements or means for the introduction of sources into the body
• CPC Class Codes: A61N 5/1015 Treatment of resected cavities created by surgery, e.g. lumpectomy

Abstract

A brachytherapy device for the provision of brachytherapy is disclosed. The brachytherapy device has at least one source lumen located outside a movable surface of the device. The source lumen may be secured to the movable outer surface in a manner whereby relative movement of the source lumen relative to the movable outer surface is permitted. The brachytherapy device is inserted into a body cavity. After insertion, the movable surface is moved to position the at least one source lumen closer to the tissue boundary of the cavity. One or more sources of radiation are then placed within the at least one source lumen to provide a customizable treatment. Also disclosed are methods for providing brachytherapy via body cavities.

Claims

1. A brachytherapy device comprising:

an elongate member comprising a proximal portion and a distal portion;

a movable surface portion surrounding at least the distal portion of the elongate member;

structure associated with said movable surface portion for causing movement of the movable surface portion from a first position to a second position;

a plurality of source lumen tubes surrounding the elongate member, the source lumen tubes secured to said proximal portion and associated with the movable surface portion, distal ends of the source lumen tubes secured to the distal portion of the elongate member, the source lumen tubes extending a sufficient distance along said proximal portion such that said source lumen tubes extend outside a body when said movable surface portion is positioned for brachytherapy in a surgical cavity and the source lumen tubes define a curved configuration within the surgical cavity, the source lumen tubes defining respective source lumens; and

a source of radiation suitable for insertion into the source lumens.

2. The brachytherapy device of claim 1, wherein the plurality of source lumen tubes comprise at least two source lumens.

3. The brachytherapy device of claim 1, wherein the plurality of source lumen tubes comprise at least four source lumens.

4. The brachytherapy device of claim 1, wherein the plurality of source lumen tubes comprise at least six source lumens.

5. The brachytherapy device of claim 1, comprising eight or nine source lumens.

6. The brachytherapy device of claim 1, wherein the elongate member comprises an internal lumen into which a radiation source may be inserted for providing brachytherapy treatment.

7. The brachytherapy device of claim 1, wherein said movable surface portion is formed by an inflatable balloon and said structure for causing movement of said movable surface portion comprises an inflation lumen.

8. The brachytherapy device of claim 7, wherein the elongate member comprises an internal lumen into which the radiation source may be inserted for providing brachytherapy treatment.

9. The brachytherapy device of claim 1, wherein said source lumens are located in a predetermined location relative to a longitudinal axis of the device when said movable surface portion is moved to said second position.

10. The brachytherapy device of claim 9, wherein said source lumen tubes are attached to a movable portion of said proximal portion to allow said source lumen tubes to move relative to said movable surface portion during movement of said movable surface portion from said first position to said second position.

11. The brachytherapy device of claim 1, wherein said source lumen tubes comprise a shape memory material.

12. The brachytherapy device of claim 1, further comprising an outer sheath around the device to act as a barrier to limit tissue ingrowth and/or retain liquid inside the device.

13. The brachytherapy device of claim 1, further comprising a coating on at least one outer surface of said device in order to reduce adhesion to body tissue.

14. The brachytherapy device of claim 1, further comprising an outer sheath comprising a material suitable to reduce a dose gradient in a treatment area.

15. A brachytherapy device comprising:

a proximal portion;

a movable surface portion;

structure associated with said movable surface portion for causing movement of the movable surface portion from a first position to a second position;

at least one tube that defines at least one source lumen attached to said proximal portion and associated with, and located outside, the movable surface portion, said at least one tube extending a sufficient distance along said proximal portion such at said at least one source lumen extends outside a body when said movable surface portion is positioned for brachytherapy in said body;

a source of radiation suitable for insertion into said at least one source lumen; and

an outer sheath around the device to act as a barrier to limit tissue ingrowth and/or retain liquid inside the device, wherein the outer sheath is bio-absorbable.

16. The brachytherapy device of claim 15, wherein the outer sheath is formed integrally with an element of the device.

17. A device for use in brachytherapy comprising:

a proximal portion;

a plurality of source lumen tubes comprising proximal ends adjacent the proximal portion and distal ends coupled together, the source lumen tubes defining an expandable structure adjacent the distal ends thereof, the source lumen tubes defining source lumens that extend from the proximal portion to the distal ends of the source lumen tubes for receiving a source of radiation therein;

an inner tube extending from the proximal portion to the distal ends of the source lumen tubes, the inner tube comprising a source lumen for receiving a source of radiation therein;

an actuator operatively associated with the source lumen tubes for causing the proximal and distal ends of the source lumen tubes to move towards one another to direct the expandable structure from a first contracted position to a second expanded position; and

a cap fixed to the distal ends of the source lumen tubes and a distal end of the inner tube.

18. The device of claim 17, wherein a proximal portion of each source lumen tube extends a sufficient distance such that a proximal portion of each source lumen tube is located outside a body when the device is positioned for brachytherapy in a body cavity.

19. The device of claim 17, further comprising a source of radiation receivable sequentially within the source lumens.

20. The device of claim 17, further comprising a membrane to help sculpt tissue adjacent the surgical cavity.

21. The device of claim 20, wherein the membrane extends between the source lumen tubes and the inner tube.

22. The device of claim 20, wherein the membrane is liquid-tight.

23. The device of claim 17, wherein the actuator comprises a plunger coupled to the source lumen tubes.

24. The device of claim 17, wherein at least a portion of the actuator is removable from the device.

25. The device of claim 17, further comprising an outer tube surrounding the proximal portion that is disposed adjacent the source lumen tubes in the second expanded condition.

26. The device of claim 17, further comprising a high dose radiation source receivable sequentially in the source lumens of the inner tube and the source lumen tubes.

27. The device of claim 17, further comprising an expandable member surrounding the expandable structure defined by the source lumen tubes.

28. The device of claim 17, wherein the expandable member comprises expandable material that opens by unfolding from a tightly folded shape into a conformed shape.