Expandable brachytherapy device

• US 8,562,504 B2
• Filed: 05/07/2010
• Issued: 10/22/2013
• 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:
  US12/775,636
• Publication Number:
  US 20100222628A1
• Time in Patent Office: 1,264 Days
• Field of Search: 600 1- 8, 604/508
• US Class Current: 600/7
• 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 treating tissue surrounding a body cavity of a patient, comprising:

a) providing a device having a distal portion, a treatment location at the distal portion of a shaft of the device and a plurality of treatment lumens extending into the treatment location configured to receive a radiation source;

b) inserting the device into the patient until the treatment location is deployed within the body cavity;

c) positioning the plurality of treatment lumens within the body cavity so that a first lumen of the plurality of treatment lumens is closer to a first portion of tissue surrounding the body cavity than a second portion of tissue surrounding the body cavity; and

d) asymmetrically irradiating tissue surrounding the body cavity by positioning a radiation source in the first lumen of the plurality of treatment lumens within the treatment location to asymmetrically irradiate tissue surrounding the body cavity.

2. The method of claim 1, further comprising:

removing the radiation source from the first lumen; and

asymmetrically irradiating tissue surrounding the body cavity by positioning the radiation source in a second lumen of the plurality of treatment lumens within the treatment location to asymmetrically irradiate tissue at a body site.

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

a. an elongated shaft having proximal and distal shaft portions and a plurality of lumens extending within an interior of the elongated shaft such that said plurality of lumens are surrounded by the elongated shaft from the proximal shaft portion to the distal shaft portion;

b. a plurality of tubular members on the distal shaft portion which have inner lumens in fluid communication with the plurality of lumens extending within an interior of the elongated shaft and configured to receive a radiation source therein;

c. an expandable member on the distal shaft portion surrounding the plurality of tubular members, having a contracted and expanded configurations and being spaced from the plurality of tubular members in the expanded configuration;

d. an adapter on the proximal shaft portion having a plurality of tubular members with inner lumens, each of which are aligned with one of the inner lumens extending within the interior of the elongated shaft and the inner lumens of the tubular members are configured to direct a radiation source to one of the lumens extending within the elongated shaft that are aligned therewith.

4. The brachytherapy device of claim 3 wherein the tubular members on the distal shaft portion have an arcuate shape with an intermediate portion extending away from the distal shaft portion.

5. The brachytherapy device of claim 4 wherein the intermediate portion of the tubular members having an arcuate shape are configured so a radiation source therein is located closer to a first portion of tissue surrounding the cavity than to an opposed second portion of tissue surrounding the cavity.

6. The brachytherapy device of claim 4 wherein the intermediate portion of the arcuate shaped tubular members is deflectable toward a first portion of tissue surrounding the cavity so that the inner lumen in the intermediate portion of each of the tubular members on the distal shaft portion is closer to a first portion of tissue surrounding the cavity than a second portion of tissue.

7. The brachytherapy device of claim 4, including a support member extending within the distal shaft portion to support the tubular members on the distal shaft portion in the arcuate configuration.

8. The brachytherapy device of claim 7 wherein the support member has a centrally disposed lumen which is axially aligned and configured to receive a radiation source.

9. The brachytherapy device of claim 7 wherein the support member has a plurality of channels configured to receive the tubular members.

10. The brachytherapy device of claim 8 wherein the tubular members on the distal shaft portion are off-set from a longitudinal axis.

11. The brachytherapy device of claim 10 wherein at least 4 tubular members on the distal shaft portion are off-set from the longitudinal axis.

12. The brachytherapy device of claim 3 wherein the expandable member is configured to at least partially fill the body cavity.

13. A brachytherapy device of claim 11 wherein the expandable member is an inflatable balloon having an interior configured to receive inflation fluid.

14. The brachytherapy device of claim 13 wherein one of the tubular members of the adapter is an inflation member with the inner lumen in fluid communication with one of said lumens extending within the elongated shaft which is in fluid communication with the interior of the inflatable balloon.

15. The device of claim 3 wherein the inner lumens of the tubular members on the distal shaft portion are defined by the tubular members on the distal shaft portion having arcuate shapes with intermediate portions extending away from the distal shaft portion.

16. The brachytherapy device of claim 15 wherein an inner lumen in the intermediate portion of one of the tubular members having an arcuate shape is configured so a radiation source therein is located closer to a first portion of tissue surrounding the cavity than to an opposed second portion of tissue surrounding the cavity.

17. A brachytherapy device for treating tissue surrounding a body cavity within a patient'"'"'s breast, comprising:

a) an elongated shaft having a distal shaft portion with a longitudinal axis, a proximal shaft portion and a plurality of lumens extending within the elongated shaft from the proximal shaft portion to the distal shaft portion;

b) a plurality of guides along the distal shaft portion which are in fluid communication with the plurality of lumens extending within the elongated shaft and which are configured to receive a radiation source therein, with at least one of the guides having an arcuate shape in a longitudinal direction and having an intermediate portion thereof extending away from a longitudinal axis a greater distance than portions of the arcuate shaped guide proximal and distal to the intermediate portion to provide asymmetric radiation;

c an expandable member on the distal shaft portion surrounding the plurality of guides, said expandable member having an expanded configuration that is independent of and spaced from the plurality of guides.

18. The device of claim 17 wherein the the guides are lumens.

19. The device of claim 18 wherein the lumens are defined at least in part by tubular members.

20. The device of claim 17 including a radiation source within at least one of the guides.

21. The device of claim 20 wherein the radiation source comprises brachytherapy seeds.

22. The brachytherapy device of claim 17 including a support member extending within the distal shaft portion to support the guides along the distal shaft portion in the arcuate shape.

23. The brachytherapy device of claim 22 wherein the support member has a centrally disposed lumen which is axially aligned and configured to receive a radiation source.

24. The brachytherapy device of claim 22 wherein the support member has a plurality of channels cofigured to receive the guides.

25. The brachytherapy device of claim 22 wherein the plurality of guides along the distal shaft portion are supported off-set from a longitudinal axis.

26. The brachytherapy device of claim 22 wherein at least 4 guides along the distal shaft portion are off-set from the longitudinal axis.

27. The brachytherapy device of claim 18 wherein the expandable member is configured to at least partially fill the body cavity.

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

29. The brachytherapy device of claim 28 wherein the elongated shaft has an inner inflation lumen which is in fluid communication with the interior of the inflatable balloon.