Expandable brachytherapy device

• US 8,684,899 B2
• Filed: 01/27/2010
• Issued: 04/01/2014
• 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:
  US12/694,741
• Publication Number:
  US 20100130807A1
• Time in Patent Office: 1,525 Days
• Field of Search: 600 1- 8
• US Class Current: 600/3
• 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 brachytherapy in a lumpectomy cavity of a breast, comprising:

positioning a distal end of a brachytherapy device within the cavity, the brachytherapy device comprising 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;

expanding an expandable surface portion located between a proximal end and the distal end of the device within the cavity, the source lumen tubes defining a curved configuration within the cavity;

positioning a source of radiation within one source lumen of the source lumen tubes, and

positioning a source of radiation within another source lumen of the source lumen tubes when in the curved configuration, said positioning steps carried out according to a brachytherapy treatment plan.

2. The method of claim 1, wherein the expandable surface portion comprises a membrane extending between the inner tube and the source lumen tubes, the expandable surface portion being expanded by movement of the source lumen tubes to position proximal ends and the distal ends of the source lumen tubes closer together.

3. The method of claim 1, wherein the expandable surface portion comprises an expandable member that acts as a barrier between the source lumen tubes and tissue surrounding the cavity.

4. The method of claim 3, wherein expanding the expandable surface portion comprises the expandable member opening by unfolding from a tightly folded shape.

5. The method of claim 1, wherein the expandable surface portion comprises elastic material.

6. The method of claim 1, wherein the expandable surface portion expands by unfolding from a tightly folded shape.

7. The method of claim 1, wherein the expandable surface portion comprises a membrane that helps sculpt tissue surrounding the cavity.

8. The method of claim 1, further comprising returning the expandable surface portion to an unexpanded state upon completion of brachytherapy.

9. The method of claim 8, further comprising:

removing the source of radiation from the one or more source lumens; and

thereafter, removing the brachytherapy device from the cavity.

10. The method of claim 1, wherein the brachytherapy treatment plan is determined by modeling radiation dosages and dose rates of the radiation source based at least in part on one or more of the shape of the lumpectomy cavity, the distance to the tissue to be treated, the desired depth of tissue irradiation, and the existence of areas of healthy or different tissue for which it is desirable to reduce or minimize the radiation dose.

11. The method of claim 1, wherein the brachytherapy treatment plan is determined using a computer program for modeling radiation dosages and dose rates.

12. A method for brachytherapy in a body cavity of a body comprising:

positioning a distal end of a brachytherapy device within the body cavity, the brachytherapy device comprising 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 body;

expanding an expandable surface portion located between a proximal end and the distal end of the device within the body cavity, the source lumen tubes defining a curved configuration within the body cavity, the expandable surface portion being expanded by moving a rod in a longitudinal direction towards the proximal end of the brachytherapy device; and

positioning a source of radiation within one source lumen of the source lumen tubes, and

positioning a source of radiation within another source lumen of the source lumen tubes, said positioning steps carried out according to a brachytherapy treatment plan.

13. The method of claim 12, wherein the expandable surface portion comprises a membrane extending between the inner tube and the source lumen tubes, the expandable surface portion being expanded by movement of the source lumen tubes to position proximal ends and the distal ends of the source lumen tubes closer together.

14. The method of claim 12, wherein the expandable surface portion comprises a membrane extending between the inner tube and the source lumen tubes.

15. The method of claim 12, further comprising returning the expandable surface portion to an unexpanded state upon completion of brachytherapy.

16. A device for use in brachytherapy comprising:

an inner tube comprising a proximal portion, a distal portion terminating in a distal end, and a source lumen extending from the proximal portion to the distal end for receiving a source of radiation therein; and

a plurality of source lumen tubes located around the inner tube and comprising proximal ends adjacent the proximal portion of the inner tube and distal ends secured together at the inner tube distal end, the source lumen tubes defining a curved configuration when positioned within a surgical cavity, the source lumen tubes defining source lumens that extend from the proximal ends to the distal ends of the source lumen tubes for receiving a source of radiation therein, and

a membrane to help sculpt tissue in the surgical cavity, said membrane being located at the distal portion of the device such that the membrane is positioned within the surgical cavity when the source lumen tubes are positioned in the same surgical cavity, and wherein the source lumen tubes are not connected to the membrane such that a distance between the membrane and the source lumen tubes can be varied.

17. The device of claim 16, wherein the membrane extends between the source lumen tubes.

18. The device of claim 16, wherein the membrane is liquid-tight.

19. The device of claim 16, further comprising an actuator operatively associated with the source lumen tubes for causing movement of the source lumen tubes to position the proximal and distal ends of the source lumen tubes closer together to direct the source lumen tubes from a contracted configuration to the curved configuration.

20. The device of claim 19, wherein the actuator comprises a plunger coupled to the source lumen tubes.

21. The device of claim 19, wherein at least a portion of the actuator is removable from the device.

22. The device of claim 16, further comprising a cap fixed to the distal ends of the source lumen tubes and the inner tube.

23. The device of claim 16, further comprising an outer tube surrounding the proximal portion that is disposed adjacent the source lumen tubes in the curved configuration.

24. The device of claim 23, wherein the outer tube is made from relatively rigid material compared to the source lumen tubes.

25. The device of claim 16, further comprising a high dose radiation source receivable sequentially in the source lumen of the inner tube and the source lumen tubes.

26. A device for use in brachytherapy comprising:

an inner tube comprising a proximal portion, a distal portion terminating in a distal end, and a source lumen extending from the proximal portion to the distal end for receiving a source of radiation therein;

a cap on the distal end of the inner tube;

a plurality of source lumen tubes located around the inner tube and comprising proximal ends adjacent the proximal portion of the inner tube and distal ends captured in the cap, the source lumen tubes defining a curved configuration when positioned within a surgical cavity, the source lumen tubes defining source lumens that extend from the proximal ends to the distal ends for receiving a source of radiation therein; and

an expandable member surrounding the source lumen tubes, and wherein the source lumen tubes are not connected to the expandable member such that a distance between the expandable member and the source lumen tubes can be varied.

27. The device of claim 26, wherein the expandable member comprises expandable material that opens by unfolding from a tightly folded shape into a conformed shape.

28. The device of claim 26, further comprising a high dose radiation source receivable sequentially in the source lumens of the inner tube and the source lumen tubes.

29. The device of claim 26, wherein the expandable member is configured to act as a barrier between the source lumen tubes and tissue surrounding the surgical cavity.

30. The device of claim 26, wherein the expandable member is configured to help sculpt tissue adjacent the surgical cavity.

31. The device of claim 26, wherein the expandable member extends between the source lumen tubes.

32. The device of claim 26, wherein the expandable member is liquid-tight.