BRACHYTHERAPY APPLICATOR

• US 20110257459A1
• Filed: 02/11/2011
• Published: 10/20/2011
• Est. Priority Date: 02/12/2010
• Status: Active Grant

• Current Assignee: Varian Medical Systems Incorporated (Siemens AG)
• Original Assignee: Varian Medical Systems Incorporated (Siemens AG)
• Inventors: LEBOVIC, Gail S., DREWS, Michael, HERMANN, George D., SUTTON, Douglas S.
• Granted Patent: US 9,642,999 B2
• Time in Patent Office: Days
• US Class Current: 600/7
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61N 2005/1018 with multiple channels for guiding radioactive sources
• CPC Class Codes: A61N 5/1016 Gynaecological radiation therapy

Abstract

Described here are brachytherapy applicators that comprise a modular support matrix. The modular support matrix may define the arrangement of radiation source lumens within the brachytherapy applicator. The modular support matrix can be adjusted to position the radiation sources to obtain a certain dose and dose profile. A series of modular support matrices may be operably connected according to patient anatomy or dosing requirements. Systems and methods for using such modular brachytherapy applicators are also described.

Claims

1. A gynecological brachytherapy applicator comprising an elongate cylindrical body having a proximal end and a distal end, the elongate body comprising a modular support matrix having a plurality of source lumens extending at least partially therethrough and defining an arrangement of the source lumens within the elongate body.

2. The gynecological brachytherapy applicator of claim 1, wherein the modular support matrix comprises a plurality of segments.

3. The gynecological brachytherapy applicator of claim 2, further comprising a membrane at least partially surrounding the elongate body.

4. The gynecological brachytherapy applicator of claim 3, wherein the membrane comprises a polymer.

5. The gynecological brachytherapy applicator of claim 4, wherein the polymer is selected from the group consisting of fluoropolymers, natural and synthetic latex, polyurethane, silicone, and combinations thereof.

6. The gynecological brachytherapy applicator of claim 2, wherein the elongate body has an unexpanded configuration and a radially expanded configuration.

7. The gynecological brachytherapy applicator of claim 6, wherein the plurality of segments define a lumen within the elongate body, the segments comprising an elongate segment body having a proximal end, a distal end, and a wall extending therebetween.

8. The gynecological brachytherapy applicator of claim 7, wherein the plurality of source lumens are symmetrically arranged within the elongate segment body.

9. The gynecological brachytherapy applicator of claim 7, wherein the plurality of source lumens are asymmetrically arranged within the elongate segment body.

10. The gynecological brachytherapy applicator of claim 7, further comprising a dilator slidably coupled to the plurality of segments within the elongate body lumen.

11. The gynecological brachytherapy applicator of claim 10, wherein the plurality of segments and the dilator each comprise one or more mating elements.

12. The gynecological brachytherapy applicator of claim 2, wherein the modular support matrix comprises a plurality of stacking components.

13. The gynecological brachytherapy applicator of claim 12, wherein the plurality of stacking components are releasably attached to one another.

14. The gynecological brachytherapy applicator of claim 12, wherein the stacking components comprise an array of channels and an integrated wall circumferentially disposed around the array.

15. The gynecological brachytherapy applicator of claim 14, wherein the channels of each segment operably connect to form the plurality of source lumens.

16. The gynecological brachytherapy applicator of claim 15, further comprising at least one conduit slidably disposed within the plurality of source lumens.

17. The gynecological brachytherapy applicator of claim 12, wherein the stacking components comprise a base having a plurality of openings and a plurality of members having a lumen extending from the base.

18. The gynecological brachytherapy applicator of claim 17, wherein the member lumens of one stacking component are connected to the member lumens of another stacking component via the openings in a base to cooperatively form source lumens.

19. The gynecological brachytherapy applicator of claim 1, wherein the applicator further comprises a central lumen extending at least partially through the elongate body.

20. The gynecological brachytherapy applicator of claim 1, wherein the applicator further comprises a hub at the proximal end of the elongate body, the hub having a proximal end and a distal end, and a proximal end diameter and a distal end diameter.

21. The gynecological brachytherapy applicator of claim 20, wherein the diameter of the hub proximal end is larger than the diameter of the hub distal end.

22. The gynecological brachytherapy applicator of claim 1, wherein the applicator further comprises an applicator tip at the distal end of the elongate body.

23. The gynecological brachytherapy applicator of claim 22, wherein the applicator tip comprises an impressible material.

24. The gynecological brachytherapy applicator of claim 23, wherein the source lumens have a distal portion embedded within the impressible material.

25. The gynecological brachytherapy applicator of claim 1, wherein the modular support matrix comprises a polymer selected from the group consisting of silicones, polyvinylchloride, latex rubber, polystyrene, and polyurethane.

26. The gynecological brachytherapy applicator of claim 1, wherein the distal end of the elongate body is flared.

27. The gynecological brachytherapy applicator of claim 1, wherein the applicator further comprises a radiation source.

28. The gynecological brachytherapy applicator of claim 27, wherein the radiation source comprises a radioactive liquid, an x-ray source, a radiation seed, or combinations thereof.

29. The gynecological brachytherapy applicator of claim 27, wherein the radiation source comprises radionuclides selected from the group consisting of cesium, iridium, iodine, cobalt, palladium, strontium, yttrium, gold, ruthenium, californium, and combinations thereof.

30. The gynecological brachytherapy applicator of claim 1, wherein the elongate body comprises between 5 and 13 source lumens.

31. The gynecological brachytherapy applicator of claim 30, wherein the elongate body comprises between 8 and 13 source lumens.

32. The gynecological brachytherapy applicator of claim 30, wherein the elongate body comprises between 10 and 13 source lumens.

33. The gynecological brachytherapy applicator of claim 30, wherein the elongate body comprises 13 source lumens.

37. The gynecological brachytherapy applicator of claim 2, wherein the modular support matrix comprises a plurality of compressible segments.

38. The gynecological brachytherapy applicator of claim 37, wherein the plurality of compressible segments comprise a hinge.

39. The gynecological brachytherapy applicator of claim 38, wherein the plurality of compressible segments comprise a lumen scaffold, an array of channels, and peripheral lumens.

40. The gynecological brachytherapy applicator of claim 39, wherein a single extension of the lumen scaffold connects the peripheral lumens to the array of channels.

41. The gynecological brachytherapy applicator of claim 39, wherein two extensions of the lumen scaffold connect the peripheral lumens to the array of channels.

34. A brachytherapy system comprising a plurality of stacking components, at least one hub, and at least one removable handle.

35. The brachytherapy system of claim 34, wherein the system further comprises one or more tips.

36. The brachytherapy system of claim 34, wherein the system further comprises one or more slidably advanceable conduits.

42. A brachytherapy system comprising:

a gynecological applicator, the applicator comprising an elongate cylindrical body having a proximal end, a distal end, and a support matrix, the support matrix comprising a wall and defining a lumen between the proximal and distal ends, wherein the support matrix has an unexpanded configuration and a radially expanded configuration, and a plurality of source lumens within the wall; and

one or more dilators for expanding the support matrix.

43. The brachytherapy system of claim 42, wherein the plurality of source lumens are symmetrically spaced within the wall.

44. The brachytherapy system of claim 42, wherein the plurality of source lumens are asymmetrically spaced within the wall.

45. The brachytherapy system of claim 42, further comprising a radiation source.

46. A method for delivering radiation therapy to a gynecological tissue comprising:

advancing a gynecological brachytherapy applicator adjacent to a target tissue, the gynecological brachytherapy applicator comprising an elongate cylindrical body having a proximal end and a distal end, the elongate body comprising a modular support matrix having a plurality of source lumens extending at least partially therethrough and defining an arrangement of the source lumens within the elongate body; and

delivering radiation therapy to the target tissue using the brachytherapy applicator.

47. The method of claim 46, wherein the modular support matrix comprises a plurality of segments.

48. The method of claim 46, wherein the modular support matrix comprises a plurality of stackable components.

49. The method of claim 46, further comprising expanding the elongate body from an unexpanded configuration to a radially expanded configuration.

50. The method of claim 46, further comprising removing the brachytherapy applicator from the vaginal canal.

51. The method of claim 46, wherein the radiation therapy is delivered by a radiation source.

52. The method of claim 51, wherein the radiation source comprises a radioactive liquid, an x-ray source, a radiation seed, or combinations thereof.

53. The method of claim 52, wherein the radiation source comprises radionuclides selected from the group consisting of cesium, iridium, iodine, cobalt, palladium, strontium, yttrium, gold, ruthenium, californium, and combinations thereof.

54. The method of claim 53, wherein the radiation source comprises iridium.

55. The method of claim 51, wherein the radiation source is loaded into the plurality of source lumens using an afterloader.

56. The method of claim 46, wherein the target tissue is the elongate portion of the uterus.

57. The method of claim 46, wherein the target tissue is the cervix.

58. The method of claim 46, wherein the target tissue is tissue of the vaginal wall or vaginal cuff.

59. The method of claim 51, wherein the radiation source is used to treat a gynecological cancer.

60. The method of claim 59, wherein the gynecological cancer is selected from the group consisting of cervical cancer, endometrial cancer, uterine cancer, ovarian cancer, and vaginal cancer.

61. The method of claim 60, wherein the gynecological cancer is endometrial cancer.

62. The method of claim 61, wherein the radiation source delivers a radiation dose of about 10 Gy to about 30 Gy to the target tissue to treat the endometrial cancer.

63. The method of claim 62, wherein the gynecological cancer is cervical cancer.

64. The method of claim 63, wherein the radiation source delivers a radiation dose of about 30 Gy to about 45 Gy to the target tissue to treat the cervical cancer.