EXPANDABLE BRACHYTHERAPY DEVICE

• US 20100222628A1
• Filed: 05/07/2010
• Published: 09/02/2010
• 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: GOVIL, AMIT PRAKASH, WHITE, JACK C., GRIFFITH, NATHAN CHRISTOPHER, STEPHENS, DAVID WESLEY, BERGMAN, JOSHUA J., MILLAGE, KYLE KEVIN
• Granted Patent: US 8,562,504 B2
• Time in Patent Office: Days
• 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 first lumen 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 treatment location within the body cavity so that the first lumen is closer to a first portion of tissue surrounding the body cavity than a second portion of tissue surrounding the body cavity; and

d) irradiating tissue surrounding the body cavity by a radiation source in the first lumen within the treatment location to asymmetrically irradiate tissue at the body site.

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

a) an elongated shaft having proximal and distal portions and a plurality of lumens extending within the shaft from the proximal portion to the distal portion;

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

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

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

3. The brachytherapy device of claim 2 wherein the tubular members on the distal shaft portion have an arcuate shape with an intermediate portion extending away from the distal shaft portion.

4. The brachytherapy device of claim 3 wherein the intermediate portion of the arcuate shaped tubular member is deflectable toward a first portion of tissue surrounding the cavity so that the lumen in the intermediate portion of the tubular member is closer to a first portion of tissue surrounding the cavity than a second portion of tissue.

5. The brachytherapy device of claim 3 including a support member extending within the distal shaft section to support the tubular members extending within the distal shaft section in the arcuate configuration.

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

7. The brachytherapy device of claim 5, wherein the support member has a plurality of channels configured to receive the tubular members.

8. The brachytherapy device of claim 6 wherein the plurality of tubular members on the distal shaft portion are off-set from a longitudinal axis.

9. The brachytherapy device of claim 8 wherein at least 4 tubular members on the distal shaft portion are off-set from the longitudinal axis.

10. The brachytherapy device of claim 2 wherein the expandable member is configured to at least partially fill the body cavity.

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

12. The brachytherapy device of claim 11 wherein one of the tubular members of the adapter is an inflation member having an inner lumen in fluid communication with an inner lumen extending within the elongated shaft which is in fluid communication with the interior of the inflatable balloon.

19. The brachytherapy device of claim 2 wherein the plurality of lumens along the distal shaft portion are defined by tubular members on the distal shaft portion having arcuate shapes with intermediate portions extending away from the distal shaft portion.

13. A brachytherapy device for treating tissue surrounding a body cavity within a patient, 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 shaft from the proximal portion to the distal portion; and

b) a plurality of guides along the distal shaft portion which are in fluid communication with 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 allow asymmetric radiation.

14. The device of claim 13 wherein the guides are lumens.

15. The device of claim 14 wherein the lumens are defined at least in part by tubular members.

16. The device of claim 13 including an expandable member on the distal shaft portion surrounding the plurality of guides, having an expanded configuration that is independent of and spaced from the plurality of guides.

17. The device of claim 13 including a radiation source within at least one of the guides.

18. The device of claim 17 wherein the radiation source comprises brachytherapy seeds.

20. The brachytherapy device of claim 13 including a support member extending within the distal shaft section to support the guides extending within the distal shaft section in the arcuate configuration.

21. The brachytherapy device of claim 20 wherein the support member has a centrally disposed lumen which is axially aligned and configured to receive a radiation source.

22. The brachytherapy device of claim 20 wherein the support member has a plurality of channels configured to receive the guides.

23. The brachytherapy device of claim 20 wherein the plurality of guides on the distal shaft portion are supported off-set from a longitudinal axis.

24. The brachytherapy device of claim 20 wherein at least 4 guides on the distal shaft portion are off-set from the longitudinal axis.

25. The brachytherapy device of claim 14 wherein the expandable member is configured to at least partially fill the body cavity.

26. The brachytherapy device of claim 25 wherein the expandable member is an inflatable balloon having an interior configured to receive inflation fluid.

27. The brachytherapy device of claim 26 wherein the elongated shaft has an inner inflation lumen which is in fluid communication the interior of the inflatable balloon.