Brachytherapy apparatus and methods for using same

• US 8,323,171 B2
• Filed: 10/04/2007
• Issued: 12/04/2012
• Est. Priority Date: 09/10/2002
• Status: Active Grant

• Current Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Original Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Inventors: Lebovic, Gail S., Hermann, George D.
• Primary Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US11/867,625
• Publication Number:
  US 20080027266A1
• Time in Patent Office: 1,888 Days
• Field of Search: 600 1- 8
• US Class Current: 600/3
• CPC Class Codes: A61N 2005/1011 Apparatus for permanent insertion of sources
• CPC Class Codes: A61N 2005/1023 Means for creating a row of seeds, e.g. spacers
• CPC Class Codes: A61N 2005/1094 Shielding, protecting against radiation
• CPC Class Codes: A61N 5/1027 Interstitial radiation therapy

Abstract

Apparatus, systems and methods are provided for delivering brachytherapy to a target tissue region of a human or other mammalian body. In some embodiments, a flexible brachytherapy device is implanted that includes a therapy delivery portion having one or more radioactive sources securely retained thereto, and a tail portion extending from the therapy delivery portion. Once implanted, the tail portion may extend outside the body, where it may be folded and secured flat against the skin. The device may be removed at therapy completion. Other embodiments of the invention are directed to systems and methods for delivering brachytherapy devices to the body.

Claims

1. A method for brachytherapy treatment of a target tissue region within a breast using a therapy device comprising a therapy delivery portion and a tail portion, comprising:

creating a puncture through the breast into the target tissue region;

advancing the therapy delivery portion of the therapy device through the puncture in a straight configuration;

deploying the therapy delivery portion within or around the target tissue region in a curved configuration; and

delivering radiation therapy to the target tissue region by introducing one or more radiation sources into the therapy delivery portion in accordance with a predefined therapy profile.

2. The method of claim 1, further comprising removing the therapy device from the target tissue region after delivering radiation therapy.

3. The method of claim 2, wherein the therapy device is removed from the target tissue region using the tail portion of the therapy device.

4. The method of claim 1, wherein a plurality of therapy delivery portions are placed at the target tissue region in curved configurations.

5. The method of claim 4, wherein the plurality of therapy delivery portions are placed at the target tissue region to provide conformance to the shape of the target tissue region.

6. The method of claim 1, wherein advancing the therapy delivery portion comprises:

introducing a tubular member through the puncture into the target tissue region; and

advancing the therapy delivery portion of the therapy device through the tubular member.

7. The method of claim 1, wherein the target tissue region comprises a tumor or lesion.

8. The method of claim 1, wherein the target tissue region comprises a cavity created by tumor excision.

9. The method of claim 1, wherein the target tissue region comprises surrounding tissue associated with a lumpectomy cavity of a breast.

10. The method of claim 1, further comprising surgically creating a cavity in the target tissue region before deploying the therapy delivery portion within or around the target tissue region.

11. The method of claim 10, wherein advancing the therapy delivery portion of the therapy device comprises positioning the therapy delivery portion at or near the cavity.

12. The method of claim 1, wherein deploying the therapy delivery portion of the therapy device comprises advancing the therapy delivery portion through a tubular member in the straight configuration and deploying the therapy delivery portion from the tubular member in the curved configuration within or around the target tissue region.

13. The method of claim 1, wherein the tubular member comprises a support member extending along and encased within the therapy delivery portion of the tubular member.

14. The method of claim 1, further comprising folding or securing the tail portion relative to skin adjacent the puncture.

15. The method of claim 1, wherein the therapy device has a uniform outer size between the therapy delivery portion and the tail portion.

16. A method for brachytherapy treatment of a target tissue region within a breast using a therapy device comprising a therapy delivery portion and a tail portion, the therapy delivery portion comprising a support member formed to impart directional curvature of the therapy delivery portion, the method comprising:

advancing the therapy delivery portion of the therapy device through tissue in a straight configuration;

deploying the therapy delivery portion within or around the target tissue region in a curved configuration; and

delivering radiation therapy to the target tissue region with the therapy delivery portion in accordance with a predefined therapy profile,

wherein the support member is formed to have curvature in its relaxed state, and wherein the support member is constrained in the straight configuration during advancement through tissue.

17. A method for brachytherapy treatment of a tumor cavity within a breast using a therapy device comprising a therapy delivery portion and a tail portion, comprising:

creating a puncture through the breast into the target tissue region;

advancing the therapy delivery portion of the therapy device through the puncture into the breast in a straight configuration;

deploying the therapy delivery portion within or around the tumor cavity in a curved configuration; and

delivering radiation therapy to tissue adjacent the tumor cavity by introducing one or more radiation sources into the therapy delivery portion in accordance with a predefined therapy profile.

18. A method for brachytherapy treatment of a target tissue region within a breast using a plurality of therapy devices comprising therapy delivery portions and tail portions, comprising:

advancing the therapy delivery portions of the therapy devices simultaneously through tissue in a straight configuration;

deploying the therapy delivery portions within or around the target tissue region in a curved configuration; and

delivering radiation therapy to the target tissue region with the therapy delivery portions in accordance with a predefined therapy profile.

19. The method of claim 18, further comprising removing the therapy devices from the target tissue region after delivering radiation therapy.

20. The method of claim 19, wherein the therapy devices are removed simultaneously from the target tissue region after delivering radiation therapy.

21. The method of claim 18, wherein the target tissue region comprises a cavity created by tumor excision.

22. The method of claim 18, wherein the target tissue region comprises surrounding tissue associated with a lumpectomy cavity of a breast.

23. The method of claim 18, wherein the target tissue region comprises a tumor or lesion.

24. A method for brachytherapy treatment of a target tissue region within a breast using a therapy device comprising a therapy delivery portion and a tail portion, comprising:

identifying a target tissue region comprising a tumor cavity within the breast via ultrasound imaging;

creating a puncture through the breast into the target tissue region;

advancing the therapy delivery portion of the therapy device through the puncture tissue in a straight configuration via ultrasound imaging;

deploying the therapy delivery portion within or around the target tissue region in a curved configuration; and

delivering radiation therapy to the target tissue region by introducing one or more radiation sources into the therapy delivery portion in accordance with a predefined therapy profile.

25. The method of claim 24, wherein advancing the therapy delivery portion comprises advancing a plurality of therapy devices through tissue into the target tissue region.

26. The method of claim 25, wherein advancing the therapy delivery portion of the therapy device comprises simultaneously locating the therapy delivery portions of the plurality of therapy devices within or around the tumor cavity.

27. The method of claim 24, further comprising surgically creating the tumor cavity in the target tissue region.

28. A method for brachytherapy treatment of a target tissue region within a breast using a plurality of therapy devices comprising therapy delivery portions and tail portions, comprising:

advancing the therapy delivery portions of the therapy devices simultaneously through tissue into the target tissue region;

deploying the therapy delivery portions within or around the target tissue region in a curved configuration; and

delivering radiation therapy to the target tissue region with the therapy delivery portions in accordance with a predefined therapy profile.

29. The method of claim 28, wherein the target tissue region comprises a cavity created by tumor excision.

30. The method of claim 28, wherein the target tissue region comprises surrounding tissue associated with a lumpectomy cavity of a breast.

31. The method of claim 28, wherein each of the therapy devices comprises a tubular member comprising a lumen extending between the therapy delivery portion and the tail portion of the respective tubular member, and wherein delivering radiation therapy to the target tissue region with the therapy delivery portions comprises introducing one or more sources of radiation into each of the tubular members.

32. The method of claim 28, further comprising removing the therapy devices from the target tissue region after delivering radiation therapy.

33. The method of claim 28, wherein the target tissue region comprises a tumor or lesion.

34. A method for brachytherapy treatment of a target tissue region including a cavity created by tumor excision within a breast using a treatment system including a plurality of tubular members, each tubular member comprising a lumen extending between a therapy delivery portion and a tail portion, the method comprising:

advancing the tubular members through tissue until the therapy delivery portions are positioned within the cavity in a curved configuration; and

delivering one or more radiation sources through the lumen of each of the tubular members into the therapy delivery portions to deliver radiation to the target tissue region,

wherein each of the tubular members comprises a support member extending along the therapy delivery portion, and wherein the support member is encased within each of the respective tubular members.

35. The method of claim 34, further comprising removing the therapy devices from the target tissue region after delivering radiation therapy.

36. The method of claim 34, wherein the support member maintains the therapy delivery portion of the tubular member in a fixed or static position within the cavity in the curved configuration.

37. A method for brachytherapy treatment of a target tissue region within a breast using a therapy device comprising a therapy delivery portion and a tail portion, comprising:

introducing a cannula through tissue to a cavity created by tumor excision within the target tissue region;

advancing the therapy device through the cannula such that the therapy delivery portion is positioned within the cavity in a curved configuration; and

delivering one or more radiation sources through the therapy delivery portion in accordance with a predefined therapy profile.

38. The method of claim 37, wherein the therapy delivery portion comprises a tubular member comprising a lumen extending between the therapy delivery portion and the tail portion and a support member extending along the therapy delivery portion, and wherein delivering one or more radiation sources comprises introducing a source of radiation through the lumen of the tubular member into the therapy delivery portion.

39. The method of claim 37, wherein the support member substantially maintains the therapy delivery portion of the tubular member in a fixed or static position within the cavity in the curved configuration.

40. The method of claim 37, wherein the therapy delivery portion comprises a tubular member comprising a lumen extending between the therapy delivery portion and the tail portion and a support member that substantially maintains the therapy delivery portion of the tubular member in a fixed or static position within the cavity in the curved configuration, and wherein delivering one or more radiation sources comprises introducing a source of radiation through the lumen of the tubular member into the therapy delivery portion.