Expandable brachytherapy device

• US 8,568,284 B2
• Filed: 02/22/2010
• Issued: 10/29/2013
• 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: White, Jack C., Stephens, David Wesley, Govil, Amit Prakash, Bergman, Joshua J., Griffith, Nathan Christopher, Millage, Kyle Kevin
• Primary Examiner(s): MATTHEWS, CHRISTINE HOPKINS
• Application Number:
  US12/710,308
• Publication Number:
  US 20100152519A1
• Time in Patent Office: 1,345 Days
• Field of Search: 600 1- 8, 604 19- 21
• 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 method for brachytherapy in a lumpectomy cavity of a breast including, positioning a distal end of a brachytherapy device within the cavity, expanding an expandable surface portion located between proximal and distal ends of the device within the cavity, the source lumen tubes defining a curved configuration within the cavity; and positioning a source of radiation sequentially within one or more source lumens of the source lumen tubes according to a brachytherapy treatment plan. The device includes an inner tube, and a plurality of source lumen tubes located around the inner tube and including distal ends secured together with the inner tube at the distal end disposed within the body cavity, the source lumen tubes comprising proximal portions sufficiently long to extend outside the breast.

Claims

1. A method for brachytherapy in a lumpectomy cavity of a breast, comprising the steps of:

positioning a distal end of a brachytherapy device within the cavity, the brachytherapy device comprising an inner tube, and a plurality of source lumen tubes defining source lumens and which source lumen tubes are located around the inner tube and include distal ends secured together with the inner tube at the distal end of the device, the inner tube and source lumen tubes comprising proximal portions sufficiently long to extend outside the breast when the device is positioned for brachytherapy;

expanding a single expandable surface portion surrounding the distal portions of the source lumen tubes and within the cavity; and

positioning one or more sources of radiation within the plurality of the source lumens according to a brachytherapy treatment plan.

2. The method of claim 1, wherein the expandable surface portion acts as a barrier to retain liquid inside the device.

3. The method of claim 1, wherein the expandable surface portion acts as a barrier between the source lumen tubes and tissue surrounding the cavity.

4. The method of claim 1, wherein the expandable surface portion helps sculpt tissue surrounding the cavity.

5. The method of claim 1, further comprising returning the expandable surface portion to an unexpanded state upon completion of brachytherapy.

6. The method of claim 1, wherein the brachytherapy treatment plan is determined by modeling radiation dosages and dose rates of the one or more sources of radiation based at least in part on one or more of a shape of the cavity, a distance to tissue to be treated, a desired depth of tissue irradiation, and an existence of areas of healthy or different tissue for which it is desirable to reduce or minimize a radiation dose.

7. The method of claim 1, wherein the brachytherapy treatment plan is determined using a computer program for modeling radiation dosages and dose rates.

8. The method of claim 1, wherein the one or more sources of radiation are positioned sequentially within said source lumens.

9. The method of claim 1, wherein the inner tube defines a source lumen and the one or more sources of radiation are positioned in the source lumen defined by the inner tube as part of the brachytherapy treatment plan.

10. The method of claim 1, wherein the source lumen tubes are positioned at predetermined locations relative to a longitudinal axis of the device.

11. The method of claim 1, wherein the source lumens are parallel during said step of positioning a distal end of a brachytherapy device within the cavity.

12. The method of claim 1, wherein the source lumen tubes are flexible.

13. The method of claim 6, wherein the radiation dose delivered to the tissue is customized to take into account the shape of the cavity.

14. The method of claim 6, wherein the radiation dose is customized to ensure that predetermined areas of tissue are sufficiently irradiated.

15. The method of claim 6, wherein the radiation dose is customized to minimize radiation to healthy tissue.

16. The method of claim 6, wherein the radiation dose is customized to take into account the distance from the one or more sources of radiation to the tissue to be treated.

17. A device for use in brachytherapy in a lumpectomy cavity of a breast comprising:

an inner tube comprising a proximal portion, a distal portion terminating in a distal end, and a source lumen extending from the proximal portion to the distal end for receiving a source of radiation therein;

a plurality of source lumen tubes located around the inner tube and comprising proximal portions and distal portions terminating at distal ends that are secured together at the inner tube distal end, the source lumen tubes defining source lumens that extend through the proximal portions to the distal ends of the source lumen tubes for receiving a source of radiation therein; and

an expandable member located around the distal portions of the source lumen tubes to help sculpt tissue adjacent the cavity, and

an attachment means which attaches a proximal end of the expandable member to the proximal portions of the source lumen tubes and the proximal portions of the source lumen tubes are sufficiently long to extend from the proximal end of the expandable member to a location outside the breast when the device is positioned for brachytherapy.

18. The device of claim 17, wherein the expandable member is liquid-tight.

19. The device of claim 18, further comprising a cap in which the distal ends of the source lumen tubes and the inner tube are captured.

20. The device of claim 19, further comprising an outer tube surrounding the proximal portion of the inner tube and the proximal portions of the source lumen tubes.

21. The device of claim 20, wherein the outer tube is made from relatively rigid material compared to the source lumen tubes.

22. The device of claim 17, wherein the expandable member is elastic.

23. The device of claim 17, wherein the expandable member provides a spacing structure that reduces a dose gradient in a treatment zone.

24. The device of claim 17, further comprising a high dose radiation source receivable sequentially in the source lumens.

25. The device of claim 17, wherein the expandable member is configured to act as a barrier between the source lumen tubes and tissue surrounding the cavity.

26. The device of claim 17, further comprising a manifold for securing the proximal portions of the source lumen tubes in position.

27. The device of claim 17, wherein the source lumen tubes are parallel prior to expansion of said expandable member.

28. The device of claim 17, wherein the source lumen tubes are flexible.

29. The device of claim 17, wherein the expandable member limits tissue ingrowth into the device.

30. The device of claim 17, wherein the attachment means is selected from the group consisting of an adhesive, melt bonding, staples and clips.

31. A device for use in brachytherapy in a lumpectomy cavity comprising:

an inner tube comprising a proximal portion, a distal portion terminating in a distal end, and a source lumen extending from the proximal portion to the distal end for receiving a source of radiation therein;

a plurality of source lumen tubes located around the inner tube and comprising proximal portions and distal portions terminating at distal ends that are secured together at the inner tube distal end, the source lumen tubes defining source lumens that extend through the proximal portions to the distal ends of the source lumen tubes for receiving a source of radiation therein;

an expandable member located around the distal portions of the source lumen tubes to help sculpt tissue adjacent the cavity; and

an outer tube surrounding the proximal portions of the inner tube and the proximal portions of the source lumen tubes, wherein the outer tube is provided with indicia identifying one or more of the source lumen tubes.