Expandable brachytherapy device

• US 9,623,260 B2
• Filed: 04/11/2013
• Issued: 04/18/2017
• 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:
  US13/861,195
• Publication Number:
  US 20130225902A1
• Time in Patent Office: 1,468 Days
• Field of Search: 600 1- 8, 604 21
• 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 brachytherapy device for treating tissue surrounding a body cavity within a patient, comprising:

a) an elongated shaft having a longitudinal axis and a distal shaft portion and having a plurality of tubular members that extend along the distal shaft portion, the distal shaft portion being configured to be deployed within the body cavity, the plurality of tubular members being configured to be radially off-set from the longitudinal axis at the distal shaft portion to facilitate asymmetric irradiation of the body cavity when the distal shaft portion is deployed within the body cavity, wherein the plurality of tubular members are configured to selectively expand away from the distal shaft portion;

b) an expandable member coupled to the elongated shaft to define an expandable volume around the distal shaft portion, and wherein the expandable member is configured to be spaced apart from the plurality of tubular members when the plurality of tubular members are expanded; and

c) a cap located on the distal shaft portion, and a distal end of each of the tubular member is secured in the cap.

2. The brachytherapy device of claim 1, wherein the expandable member is configured to expand separately from the plurality of tubular members.

3. A brachytherapy device for facilitating asymmetrical irradiation of a body cavity, comprising:

an elongated shaft having a proximal end, a distal end, and a distal shaft portion proximal to the distal end, the elongated shaft having a centrally located longitudinal axis; and

an expandable member coupled to the elongated shaft to define an expandable volume at the distal shaft portion,

the elongated shaft including;

a plurality of off-set radiation delivery lumens, each off-set radiation delivery lumen of the plurality of off-set radiation delivery lumens having a respective off-set treatment portion radially off-set from the longitudinal axis within the expandable volume defined by the expandable member, and with each off-set radiation delivery lumen of the plurality of off-set radiation delivery lumens being configured to selectively expand away from the longitudinal axis and receive a radiation source and guide the radiation source into the respective off-set treatment portion;

an inflation lumen coupled in fluid communication with the expandable volume defined by the expandable member, the inflation lumen being configured for connection to an inflation fluid source, wherein the expandable member is configured to be spaced apart from the plurality of off-set radiation delivery lumens when the plurality of off-set radiation delivery lumens are expanded; and

a cap located on the distal shaft portion, and a distal end of each of the off-set radiation delivery lumens is secured in the cap.

4. The brachytherapy device of claim 3, wherein each respective off-set radiation delivery lumen is configured to slidably hold the radiation source at a selected dwell position within the respective off-set treatment portion.

5. The brachytherapy device of claim 3, wherein the elongated shaft further includes a central radiation delivery lumen having a central treatment portion located within the expandable volume on the longitudinal axis, with each respective off-set treatment portion being radially off-set from the central treatment portion.

6. The brachytherapy device of claim 5, wherein each respective off-set treatment portion and the central treatment portion extends longitudinally across the expandable volume defined by the expandable member.

7. The brachytherapy device of claim 5, wherein each respective off-set treatment portion and the central treatment portion is located at a respective fixed position relative to the longitudinal axis.

8. The brachytherapy device of claim 5, wherein each of the plurality of off-set radiation delivery lumens, the central radiation delivery lumen, and the inflation lumen has a respective proximal portion that extends proximally from the proximal end of the elongated shaft.

9. The brachytherapy device of claim 8, wherein at least the respective proximal portion of each of the plurality of off-set radiation delivery lumens, the central radiation delivery lumen, and the inflation lumen is flexible to facilitate movement of the respective proximal portion relative to the elongated shaft.

10. The brachytherapy device of claim 5, comprising three off-set treatment portions equally disposed around the central treatment portion.

11. The brachytherapy device of claim 3, comprising multiple off-set treatment portions equally disposed around the longitudinal axis.

12. The brachytherapy device of claim 3, wherein the expandable member is a balloon.

13. The brachytherapy device of claim 3, wherein the expandable member is configured to expand separately from the plurality of off-set radiation delivery lumens.

14. A brachytherapy device for facilitating asymmetrical irradiation of a body cavity, comprising:

an elongated shaft having a proximal end, a distal end, and a distal shaft portion proximal to the distal end; and

an expandable member coupled to the elongated shaft to define an expandable volume at the distal shaft portion,

the elongated shaft including;

a central radiation delivery lumen having a central treatment portion located within the expandable volume,

a plurality of off-set radiation delivery lumens, each off-set radiation delivery lumen of the plurality of off-set radiation delivery lumens having a respective off-set treatment portion radially off-set from the central treatment portion within the expandable volume, wherein the plurality of off-set radiation delivery lumens are configured to expand away from the central radiation delivery lumen,

the central radiation delivery lumen and each off-set delivery lumen of the plurality of off-set radiation delivery lumens being respectively configured to receive a radiation source and guide the radiation source into the respective treatment portion,

an inflation lumen coupled in fluid communication with the expandable volume defined by the expandable member, wherein the expandable member is configured to be spaced apart from the plurality of off-set radiation delivery lumens when the plurality of off-set radiation delivery lumens are expanded, and

a cap located on the distal shaft portion, and a distal end of each of the off-set radiation delivery lumens is secured in the cap.

15. The brachytherapy device of claim 14, wherein each respective off-set radiation delivery lumen is configured to slidably hold the radiation source at a selected dwell position within the respective off-set treatment portion.

16. The brachytherapy device of claim 14, wherein the central radiation delivery lumen is configured to slidably hold the radiation source at a selected dwell position within the central treatment portion.

17. The brachytherapy device of claim 14, wherein each respective off-set treatment portion and the central treatment portion extends longitudinally across the expandable volume defined by the expandable member.

18. The brachytherapy device of claim 14, wherein each respective off-set treatment portion and the central treatment portion is located at a respective fixed position relative to a central longitudinal axis of the elongated shaft.

19. The brachytherapy device of claim 14, wherein each of the plurality of off-set radiation delivery lumens, the central radiation delivery lumen, and the inflation lumen has a respective proximal portion that extends proximally from the proximal end of the elongated shaft.

20. The brachytherapy device of claim 19, wherein at least the respective proximal portion of each of the plurality of off-set radiation delivery lumens, the central radiation delivery lumen, and the inflation lumen is flexible to facilitate movement of the respective proximal portion relative to the elongated shaft.

21. The brachytherapy device of claim 14, comprising three off-set treatment portions equally disposed around the central treatment portion.

22. The brachytherapy device of claim 14, comprising multiple off-set treatment portions equally disposed around the central treatment portion.

23. The brachytherapy device of claim 14, wherein the expandable member is configured to expand separately from the plurality of off-set radiation delivery lumens.