Expandable brachytherapy device

• US 9,808,650 B2
• Filed: 07/08/2015
• Issued: 11/07/2017
• 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:
  US14/794,551
• Publication Number:
  US 20150306421A1
• Time in Patent Office: 853 Days
• 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) a shaft having a proximal portion, a distal portion, a distal treatment portion proximate to the distal portion, and a longitudinal axis, the shaft having a plurality of flexible tubes defining off-set radiation delivery lumens radially off-set from the longitudinal axis, each of the plurality of off-set radiation delivery lumens being configured to receive a radiation source, and the plurality of off-set radiation delivery lumens are deformable into an arcuate shape;

b) an expandable member coupled to the shaft to define an expandable volume that surrounds the distal treatment portion, the expandable member being configured to provide spacing between said distal treatment portion and a treatment zone to reduce a dose gradient to said treatment zone treated by said distal treatment portion; and

c) a cap located on the distal portion of the shaft, and a distal end of each of the plurality of flexible tubes is secured in the cap.

2. The brachytherapy device of claim 1 wherein the plurality of off-set radiation delivery lumens on the distal shaft portion have an arcuate shape with an intermediate portion extending away from the distal shaft portion.

3. The brachytherapy device of claim 2 wherein each of the intermediate portions of the off-set radiation delivery lumens is deflectable toward a first portion of tissue surrounding the cavity so that the lumen in each of the intermediate portions of the off-set radiation delivery lumens is closer to a first portion of tissue surrounding the cavity than a second portion of tissue.

4. The brachytherapy device of claim 2 including a support member extending within the distal shaft portion to support the plurality of off-set radiation delivery lumens extending within the distal shaft portion in the arcuate shape.

5. The brachytherapy device of claim 4 wherein the support member has a central radiation delivery lumen which is axially aligned and configured to receive a radiation source.

6. The brachytherapy device of claim 4, wherein the support member has a plurality of channels configured to receive the plurality of off-set radiation delivery lumens.

7. The brachytherapy device of claim 1 wherein the plurality of off-set radiation delivery lumens include at least 4 off-set radiation delivery lumens.

8. The brachytherapy device of claim 1 wherein the expandable member is configured to at least partially fill the body cavity.

9. The brachytherapy device of claim 8 wherein the expandable member is an inflatable balloon having an interior configured to receive inflation fluid.

10. The brachytherapy device of claim 9 wherein one of the plurality of off-set radiation delivery lumens is an inflation lumen in fluid communication with an inner lumen extending within the shaft which is in fluid communication with the interior of the inflatable balloon.

11. A brachytherapy device for treating tissue surrounding a body cavity within a patient, comprising:

a) a shaft having a proximal portion, a distal portion, a distal treatment portion proximate to the distal portion, and a longitudinal axis, the shaft having a plurality of flexible tubes defining off-set radiation delivery lumens radially off-set from the longitudinal axis and a central radiation delivery lumen extending into the distal treatment portion, each of the a plurality of off-set radiation delivery lumens being configured to receive a radiation source, wherein the plurality of off-set radiation delivery lumens are deformable into an arcuate shape;

b) an expandable member coupled to the shaft to define an expandable volume that surrounds the distal treatment portion, the expandable member being configured to provide spacing between said distal treatment portion and a treatment zone to reduce a dose gradient to said treatment zone treated by said distal treatment portion; and

c) a cap located on the distal portion of the shaft, and a distal end of each of the plurality of flexible tubes is secured in the cap.

12. The brachytherapy device of claim 11 wherein the plurality of off-set radiation delivery lumens on the distal shaft portion have an arcuate shape with an intermediate portion extending away from the distal shaft portion.

13. The brachytherapy device of claim 12 wherein the intermediate portion of each of the off-set radiation delivery lumens is deflectable toward a first portion of tissue surrounding the cavity so that the lumens in the intermediate portions of the off-set radiation delivery lumens is closer to a first portion of tissue surrounding the cavity than a second portion of tissue.

14. The brachytherapy device of claim 12 including a support member extending within the distal shaft portion to support the plurality of off-set radiation delivery lumens extending within the distal shaft portion in the arcuate shape.

15. The brachytherapy device of claim 14, wherein the support member has a plurality of channels configured to receive the plurality of off-set radiation delivery lumens.

16. The brachytherapy device of claim 11 wherein the plurality of off-set radiation delivery lumens include at least 4 off-set radiation delivery lumens.

17. The brachytherapy device of claim 11 wherein the expandable member is configured to at least partially fill the body cavity.

18. The brachytherapy device of claim 17 wherein the expandable member is an inflatable balloon having an interior configured to receive inflation fluid.

19. The brachytherapy device of claim 18 wherein one of the plurality of off-set radiation delivery lumens is an inflation lumen in fluid communication with an inner lumen extending within the shaft which is in fluid communication with the interior of the inflatable balloon.

20. The brachytherapy device of claim 19 wherein the inflation lumen has a barrier for retaining the fluid in the inflatable balloon when the barrier is in a closed position.