Brachytherapy apparatus and method for treating a target tissue through an external surface of the tissue

• US 20050101825A1
• Filed: 11/07/2003
• Published: 05/12/2005
• Est. Priority Date: 11/07/2003
• Status: Active Grant

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Proxima Therapeutics, Inc.
• Inventors: Patrick, Timothy J., Stubbs, James B., Winkler, Rance A., Salazar, Bartolome J.
• Granted Patent: US 7,494,457 B2
• Time in Patent Office: Days
• US Class Current: 600/3
• CPC Class Codes: A61N 2005/1021 Radioactive fluid
• CPC Class Codes: A61N 5/1015 Treatment of resected cavities created by surgery, e.g. lumpectomy

Abstract

A brachytherapy device is provided for treating a target tissue through an external surface area of the target tissue. The device includes an insertion member having a proximal portion, a distal portion, and at least one lumen extending therethrough. A fluid retaining member is mated to the distal portion of the insertion member and has a first surface shaped to conform to a predetermined external surface area of a tissue to be treated, and a cavity formed therein in fluid communication with the at least one lumen in the insertion member. A plurality of anchor members can be distributed about a periphery of the first surface to anchor the first surface to an external surface area of a tissue to be treated.

Claims

1. A brachytherapy device for treating a target tissue through an external surface area of the target tissue, comprising:

an insertion member having a proximal portion, a distal portion, and at least one lumen extending therethrough; and

a fluid retaining member mated to the distal portion of the insertion member and having a first surface shaped to conform to a predetermined external surface area of a tissue to be treated, and a cavity formed therein in fluid communication with the at least one lumen in the insertion member;

wherein the brachytherapy device is adapted to receive a radiation source through the at least one lumen into the cavity in the fluid retaining member for delivering radiation to the tissue to be treated.

2. The device of claim 1, wherein the fluid retaining member includes a plurality of anchor members distributed about a periphery of the first surface to anchor the first surface to an external surface area of a tissue to be treated.

3. The device of claim 2, wherein the plurality of anchor members are selected from the group consisting of an eyelet, a hook, an adhesive, and combinations thereof.

4. The device of claim 1, wherein the fluid retaining member is shaped to provide a uniform radiation dosage throughout the first surface when the fluid retaining member is filled with a radioactive fluid.

5. The device of claim 1, wherein the radiation source received through the at least one lumen is a solid radiation source.

6. The device of claim 1, wherein the radiation source received through the at least one lumen is in the form of a gas.

7. The device of claim 4, further comprising a radiation source in the form of a liquid and wherein the fluid retaining member is effective to removably receive the radiation source.

8. The device of claim 1, wherein the first surface is substantially planar.

9. The device of claim 1, wherein the fluid retaining member includes a second surface opposed to the first surface, and a peripheral wall extending between the first and second surfaces to define the cavity therein.

10. The device of claim 9, wherein the peripheral wall has a substantially uniform depth.

11. The device of claim 9, wherein the fluid retaining member is substantially disk-shaped.

12. The device of claim 9, wherein at least a portion of at least one of the second surface and the peripheral wall are radio-opaque to protect non-targeted tissue from radiation.

13. The device of claim 1, wherein the fluid retaining member is movable between a closed position in which the fluid retaining member is disposed adjacent the insertion member, and an open position in which the fluid retaining member extends outward from the insertion member.

14. The device of claim 13, wherein the fluid retaining member is an expandable balloon member that is inflated in the open position and deflated in the closed position.

15. The device of claim 14, wherein the expandable balloon member has a predetermined shape in the open position such that, when inflated, the expandable balloon member is effective to cover a predetermined area of tissue.

16. The device of claim 15, wherein the predetermined shape of the expandable balloon member is substantially disk-shaped.

17. The device of claim 13, wherein the fluid retaining member is formed of a shape memory material, and wherein the fluid retaining member has a three-dimensional shape in the open position, and a substantially folded shape in the closed position.

18. The device of claim 17, wherein the fluid retaining member is substantially disk-shaped in the open position.

19. The device of claim 1, wherein the insertion member is a flexible catheter.

20. The device of claim 1, wherein the tissue to be treated is a lung.

21. A brachytherapy device, comprising:

an elongate catheter member having a proximal portion, a distal portion, and at least one lumen extending therethrough;

a balloon member disposed around the distal portion of the elongate catheter member and having a cavity formed therein and in fluid communication with at least one lumen in the elongate catheter, the balloon member having a first tissue contacting surface shaped to conform to a predetermined external surface area of a tissue to be treated; and

a radiation source in the form of a liquid disposed within the cavity of the balloon.

22. The device of claim 21, wherein the balloon member includes a plurality of anchor members distributed about a periphery of the first surface to anchor the first surface to an external surface area of a tissue to be treated.

23. The device of claim 22, wherein the plurality of anchor members are selected from the group consisting of an eyelet, a hook, an adhesive, and combinations thereof.

24. The device of claim 21, wherein the balloon member is shaped to provide a uniform radiation dosage throughout the first surface.

25. The device of claim 21, wherein the first surface is substantially planar.

26. The device of claim 21, wherein the balloon member includes a second surface opposed to the first surface, and a peripheral wall extending between the first and second surfaces to define the cavity therein.

27. The device of claim 26, wherein the peripheral wall has a substantially uniform depth.

28. The device of claim 26, wherein the balloon member is substantially disk-shaped.

29. The device of claim 26, wherein at least a portion of at least one of the second surface and the peripheral wall are radio-opaque to protect non-targeted tissue from radiation.

30. The device of claim 21, wherein the balloon member is movable between a closed, deflated position in which the fluid retaining member is disposed adjacent the insertion member, and an open, inflated position in which the fluid retaining member extends outward from the insertion member.

31. The device of claim 30, wherein the expandable balloon member has a predetermined shape in the open position such that, when inflated, the expandable balloon member is effective to cover a predetermined area of tissue.

32. The device of claim 31, wherein the predetermined shape of the expandable balloon member is substantially disk-shaped.

33. The device of claim 21, wherein the insertion member is a flexible catheter.

34. A brachytherapy device for treating a target tissue through an external surface area of the target tissue, comprising:

an insertion member having a proximal portion, a distal portion, and at least one lumen extending therethrough; and

an balloon member mated to the distal portion of the insertion member and having a first surface shaped to conform to a predetermined external surface area of a tissue to be treated, and a first and a second cavity formed therein, each cavity in fluid communication with at least one lumen in the insertion member;

wherein the brachytherapy device is adapted to receive a radiation source through a lumen into at least one of the first and second cavities in the fluid retaining member for delivering radiation to the tissue to be treated.

35. The device of claim 34, wherein the first cavity is positioned between the second cavity and the tissue to be treated.

36. The device of claim 35, wherein the first cavity is effective to space a radiation source positioned in the second cavity a distance apart from a tissue surface.

37. The device of claim 35, wherein the first cavity is adapted for receiving and delivering a therapeutic agent to the tissue to be treated.

38. The device of claim 37, wherein the first surface is formed of a porous material for delivering a therapeutic agent.

39. The device of claim 37, wherein the therapeutic agent is selected form the group consisting of a chemotherapy agent, an anti-neoplastic agent, an anti-angiogenesis agent, an immunomodulator, a hormonal agent, an immunotherapeutic agent, an antibiotic, and combinations thereof.

40. A method for treating a target tissue through an external surface area of the target tissue, comprising:

providing at least one brachytherapy apparatus for delivering radioactive emissions, the apparatus having

a catheter member having proximal and distal ends and at least one lumen extending therethrough,

at least one fluid retaining member disposed proximate to the distal end of the catheter member, the fluid retaining member including a cavity formed therein in communication with the at least one lumen in the catheter member, and a first surface shaped to conform to a predetermined external surface area of a tissue to be treated;

intraoperatively placing the at least one brachytherapy apparatus on an external tissue surface of a tissue to be treated;

introducing a controlled dose of a radiation source through the at least one lumen in the catheter to the fluid retaining member to treat tissue.

41. The method of claim 40, wherein the radiation source is placed into the brachytherapy apparatus after placement of the apparatus on a tissue surface.

42. The method of claim 40, further comprising the steps of removing the radiation source from the apparatus, and removing the apparatus.

43. The method of claim 40, further comprising the step of attaching the fluid retaining member to the predetermined external surface area of a tissue to be treated.

44. The method of claim 43, wherein the fluid retaining member is attached to the predetermined external surface area of a tissue to be treated using a fastening device selected from the group consisting of staples, sutures, clips, pins, nails, screws, barbs, and combinations thereof.

45. The method of claim 40, wherein the fluid retaining member is effective to removably receive the radiation source, and wherein the radiation source is in a fluid form.

46. The method of claim 40, wherein the fluid retaining member is movable between a closed position in which the fluid retaining member is disposed adjacent the catheter member, and an open position in which the fluid retaining member extends outward from the catheter member

47. The method of claim 46, wherein the fluid retaining member is an expandable balloon member that is inflated in the open position and deflated in the closed position.

48. The method of claim 47, wherein the expandable balloon member has a predetermined shape in the open position such that, when inflated, the balloon member is effective to cover the predetermined external surface of a tissue to be treated.

49. The method of claim 48, wherein the predetermined shape of the balloon member is substantially disk-shaped.

50. The method of claim 40, wherein the fluid retaining member is formed of a shape memory material, and wherein the fluid retaining member has a three-dimensional shape in the open position, and a substantially folded shape in the closed position.

51. The method of claim 50, wherein the fluid retaining member is substantially disk-shaped in the open position.

52. The method of claim 40, wherein the fluid retaining member has a size adapted to receive a predetermined amount of a fluid radiation source.