Brachytherapy apparatus and methods for using same

• US 8,795,145 B2
• Filed: 05/07/2009
• Issued: 08/05/2014
• Est. Priority Date: 09/10/2002
• Status: Active Grant

• Current Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Original Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Inventors: Hermann, George D., Lebovic, Gail S.
• Primary Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US12/437,534
• Publication Number:
  US 20090216064A1
• Time in Patent Office: 1,916 Days
• Field of Search: 600 1- 8
• US Class Current: 600/3
• CPC Class Codes: A61N 2005/1011 Apparatus for permanent insertion of sources
• CPC Class Codes: A61N 2005/1023 Means for creating a row of seeds, e.g. spacers
• CPC Class Codes: A61N 2005/1094 Shielding, protecting against radiation
• CPC Class Codes: A61N 5/1027 Interstitial radiation therapy

Abstract

Apparatus, systems and methods are provided for delivering brachytherapy to a target tissue region of a human or other mammalian body. A flexible brachytherapy device may be implanted that includes a therapy delivery portion having one or more radioactive sources securely retained thereto, and a tail portion extending from the therapy delivery portion. Once implanted, the tail portion may extend outside the body, where it may be folded and secured flat against the skin. The device may be removed at therapy completion.

Claims

1. A system for delivering brachytherapy to a target tissue region within a breast, the system comprising a plurality of elongate therapy devices, each therapy device comprising:

an elongate tubular member comprising a tail portion including a proximal end, and a therapy delivery portion including a distal end sized for introduction through tissue of a breast to a target tissue region, and a first lumen extending between an opening in the proximal end and the distal end;

a support member extending along the therapy delivery portion of the tubular member outside the first lumen without extending to the tail portion, the support member substantially fixed relative to the therapy delivery portion;

the therapy delivery portion positionable in a curved configuration within the breast for delivery of radiation to the target tissue region, wherein the support member biases the target therapy portion for advancement through tissue in a straight configuration and allows deployment to the curved configuration within the target tissue region, the support member substantially maintaining the therapy delivery portion in a fixed or static position in the curved configuration when deployed within the target tissue region; and

the tail portion sufficiently long to extend from the breast when the target delivery portion is introduced into the target tissue region of the breast,

whereby the plurality of elongate therapy devices is advanceable through tissue until the therapy delivery portion of each of the tubular members is positioned within or around the target tissue region in the curved configuration, allowing a radiation source to be introduced into the first lumen of the each of the tubular members through the opening in the proximal end for delivering radiation therapy to the target tissue region.

2. The system of claim 1, wherein each therapy delivery portion is configured in the curved configuration to provide conformance of the therapy delivery portion to a shape of the target tissue region to be irradiated.

3. The system of claim 1, further comprising means for delivering the plurality of elongate therapy devices through tissue to the target tissue region.

4. The system of claim 3, wherein the means for delivering the plurality of elongate therapy devices comprises a plurality of tubular members for receiving respective therapy devices therethrough.

5. The system of claim 1, further comprising one or more radiation sources introduceable into the first lumen through the opening in the proximal end for delivering radiation therapy to the target tissue region.

6. The system of claim 5, wherein the one or more radiation sources comprise a plurality of radioactive seeds spaced apart along each of the therapy delivery portions.

7. The system of claim 5, wherein the one or more radiation sources comprise a HDR afterload cable.

8. The system of claim 1, wherein the tubular member comprises heat shrink tubing.

9. The system of claim 1, wherein the support member has curvature in its relaxed state.

10. The system of claim 1, wherein the support member is sufficiently flexible to permit curved implantation.

11. The system of claim 1, wherein the tubular member comprises a second lumen containing the support member.

12. The system of claim 1, wherein the support member is encased within the tubular member.

13. The system of claim 1, wherein the tubular member and support member comprise a plastic co-extrusion.

14. The system of claim 1, wherein the support member is configured for attenuating or shielding radiation to surrounding tissue.

15. The system of claim 1, wherein the support member comprises a strip of material.

16. The system of claim 1, wherein the support member has a cross-section defining a width extending transversely relative to the first lumen and a height orthogonal to the width, the height being smaller than the width.

17. The system of claim 16, wherein the support member is disposed adjacent the first lumen such that the width of the support member extends only partially around the first lumen.

18. The system of claim 1, wherein the support member has a flat cross-section.

19. The system of claim 1, wherein the support member has an arcuate cross-section.

20. An implantable brachytherapy treatment system for treating a target tissue region within a breast, comprising:

at least one elongate tubular member comprising a proximal end, a distal end sized for introduction through tissue of a breast to a target tissue region, and a first lumen extending between an opening in the proximal end and the distal end; and

a support member extending along a therapy delivery portion between the proximal end and distal end of the tubular member outside the first lumen, the support member substantially fixed relative to the therapy delivery portion, the support member offset asymmetrically relative to the first lumen for delivering the tubular member through tissue in a straight configuration and deploying the target delivery portion in a curved configuration within or around the target tissue region, wherein the support member biases the therapy delivery portion for advancement through tissue in a straight configuration and allows deployment to the curved configuration within the target tissue region; and

a radiation source receivable in the first lumen of the tubular member through the opening in the proximal end for delivering radiation therapy to the target tissue region in the curved configuration after the target delivery portion has been introduced into the target tissue region.

21. The system of claim 20, wherein the support member substantially maintains the therapy delivery portion in a fixed or static position in the curved configuration when deployed within the target tissue region.

22. The system of claim 20, wherein the wherein the at least one tubular member comprises heat shrink tubing.

23. The system of claim 20, wherein the support member is enclosed within the tubular member along the therapy delivery portion.

24. The system of claim 20, wherein the tubular member comprises a second lumen extending along the therapy delivery portion adjacent the first lumen, and wherein the support member is substantially fixed within the second lumen.

25. The system of claim 20, wherein the support member comprises a strip of material.

26. The system of claim 20, wherein the support member is configured for attenuating or shielding radiation to surrounding tissue.

27. The system of claim 20, wherein the support member has curvature in its relaxed state, the system further comprising a cannula for constraining the tubular member in the straight configuration for introduction through tissue.

28. The system of claim 20, wherein the radiation source comprises an afterload HDR cable.

29. The system of claim 20, wherein the support member has a flat cross-section.

30. The system of claim 20, comprising a plurality of tubular members including the at least one tubular member, the plurality of tubular members configured for simultaneous introduction through tissue of a breast to a target tissue region in a straight configuration and deployable in a curved configuration within or around the target tissue region.