Brachytherapy applicator

• US 9,642,999 B2
• Filed: 02/11/2011
• Issued: 05/09/2017
• Est. Priority Date: 02/12/2010
• Status: Expired due to Fees

• Current Assignee: Varian Medical Systems Incorporated (Siemens AG)
• Original Assignee: Varian Medical Systems Incorporated (Siemens AG)
• Inventors: Sutton, Douglas S., Hermann, George D., Drews, Michael, Lebovic, Gail S.
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US13/026,041
• Publication Number:
  US 20110257459A1
• Time in Patent Office: 2,279 Days
• Field of Search: 600 1- 8
• 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 in a longitudinal axis, the elongate body comprising a modular support matrix comprising a plurality of discreet units having a plurality of source lumens extending at least partially through the plurality of discreet units, and the plurality of discreet units collectively defining an arrangement of the source lumens within the elongate body, wherein the plurality of discreet units are radially expandable, providing the elongate body an unexpanded configuration and a radially expanded configuration;

wherein the plurality of discreet units comprise a plurality of modular segments assembled around the longitudinal axis to collectively define a central lumen, wherein each of the plurality of modular segments has a shape in the unexpanded configuration of the elongate body and retains the shape in the radially expanded configuration of the elongate body.

2. The gynecological brachytherapy applicator of claim 1, wherein the plurality of discreet units comprise a plurality of segments having a similar configuration.

3. The gynecological brachytherapy applicator of claim 2, wherein the plurality of modular segments are held together by one or more flexible membranes in the radially expanded configuration of 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, each of 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 at least two or more of the plurality of source lumens are symmetrically arranged within the elongate segment body relative to the longitudinal axis.

9. The gynecological brachytherapy applicator of claim 7, wherein at least two or more of the plurality of source lumens are asymmetrically arranged within the elongate segment body relative to the longitudinal axis.

10. The gynecological brachytherapy applicator of claim 1, further comprising a dilator configured to engage with the plurality of modular segments in the central lumen to allow the elongate body to radially expand, wherein the plurality of segments and the dilator each comprise one or more mating elements, and the mating elements of the plurality of segments comprising central protrusions defining an outer perimeter of the center lumen.

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

12. 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.

13. The gynecological brachytherapy applicator of claim 12, wherein the diameter of the hub proximal end is larger than the diameter of the hub distal end.

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

15. The gynecological brachytherapy applicator of claim 14, wherein the applicator tip comprises an impressible material.

16. The gynecological brachytherapy applicator of claim 15, wherein the source lumens have a distal portion embedded within the impressible material.

17. 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.

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

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

20. The gynecological brachytherapy applicator of claim 19, wherein the radiation source comprises source selected from the group consisting of a radioactive liquid, an x-ray source, a radiation seed, and combinations thereof.

21. The gynecological brachytherapy applicator of claim 19, 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.

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

23. The gynecological brachytherapy applicator of claim 22, wherein the elongate body comprises between 8 and 13 source lumens.

24. The gynecological brachytherapy applicator of claim 22, wherein the elongate body comprises between 10 and 13 source lumens.

25. The gynecological brachytherapy applicator of claim 22, wherein the elongate body comprises 13 source lumens.

26. The gynecological brachytherapy applicator of claim 1 wherein the plurality of discreet units are rigid.

27. The gynecological brachytherapy applicator of claim 1 wherein the plurality of discreet units are semi-rigid.

28. A gynecological brachytherapy applicator, comprising:

an elongate cylindrical body having a proximal end and a distal end and comprises a plurality of discreet units having a plurality of source lumens extending at least partially through the plurality of discreet units, and the plurality of discreet units collectively defining an arrangement of the source lumens within the elongate body;

wherein the plurality of discreet units comprise a plurality of stacking components connected in a series, defining a longitudinal length of the elongate cylindrical body;

wherein each of the stacking components has a cylindrical configuration and comprises an array of channels, a scaffold structure positioning the array of channels, and an integrated wall in the cylindrical configuration circumferentially disposed around the array of channels, and

wherein the integrated walls of the plurality of stacking components are releasably connected to one another in series wherein the channels of each stacking component operably connect to form the plurality of source lumens.

29. The gynecological brachytherapy applicator of claim 28, wherein the plurality of stacking components are releasably attached to one another.

30. The gynecological brachytherapy applicator of claim 28, further comprising at least one conduit slidably disposed within the plurality of source lumens.

31. The gynecological brachytherapy applicator of claim 28, wherein the stacking components comprise a base having a plurality of openings and a plurality of members having a lumen extending from the base.

32. The gynecological brachytherapy applicator of claim 31, 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.

33. A brachytherapy system, comprising:

a plurality of stacking components, at least one hub, and at least one removable handle,

wherein each of the stacking components has a cylindrical configuration and comprises an array of channels, a scaffold structure positioning the array of channels, and an integrated wall in the cylindrical configuration circumferentially disposed around the array of channels, and wherein the integrated walls of the plurality of stacking components are releasably attached to one another in series, defining a longitudinal length of the brachytherapy system, wherein channels of each stacking components operably connect to form a plurality of source lumens.

34. The brachytherapy system of claim 33, wherein the system further comprises one or more tips.

35. The brachytherapy system of claim 33, wherein the system further comprises one or more slidably advanceable conduits.

36. A gynecological brachytherapy applicator, comprising:

an elongate cylindrical body comprising a plurality of elongate compressible segments each having a length, an array of channels extending longitudinally and continuously along the length of the plurality of elongate compressible segments and supported by the plurality of elongate compressible segments, and a plurality of peripheral lumens extending longitudinally and continuously along the length of the plurality of elongate compressible segments and supported by the plurality of elongate compressible segments,

wherein the plurality of compressible segments provide the applicator a compressed state for advancement of the applicator to a target tissue and an uncompressed deployed state, and each of the plurality of compressible segments comprises a lumen scaffold connecting the plurality of peripheral lumens to the array of channels.

37. The gynecological brachytherapy applicator of claim 36, wherein the lumen scaffold comprises a hinge.

38. The gynecological brachytherapy applicator of claim 36, wherein the lumen scaffold has a single-extension configuration connecting the peripheral lumens to the array of channels.

39. The gynecological brachytherapy applicator of claim 36, wherein the lumen scaffold has a multi-extension configuration connecting the peripheral lumens to the array of channels.

40. 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 having a length extending continuously between the proximal and distal ends of the elongate cylindrical body and defining a lumen between the proximal and distal ends, wherein the wall has an unexpanded configuration and a radially expanded configuration, and a plurality of source lumens embedded within the wall and extending longitudinally and continuously along the length of the wall; and

wherein the wall is constructed from an elastic material and the plurality of source lumens are received by the elastic material constructing the wall.

41. The brachytherapy system of claim 40, wherein the plurality of source lumens are symmetrically spaced within the wall relative to a longitudinal axis of the elongate cylindrical body.

42. The brachytherapy system of claim 40, wherein the plurality of source lumens are asymmetrically spaced within the wall.

43. The brachytherapy system of claim 40, further comprising a radiation source.

44. The brachytherapy system of claim 40 wherein the wall of the support matrix includes an end portion having a curved contour, and the plurality of source lumens within the wall have a section of a curved shape generally corresponding to the curved contour of the end portion.

45. 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 comprising a plurality of discreet units having a plurality of source lumens extending at least partially through the plurality of discreet units, and the plurality of discreet units collectively defining an arrangement of the source lumens within the elongate body, wherein the plurality of discreet units are radially expandable, providing the elongate body an unexpanded configuration and a radially expanded configuration, and wherein the plurality of discreet units comprise a plurality of modular segments assembled around a longitudinal axis of the elongate cylindrical body to collectively define a central lumen, wherein each of the plurality of modular segments has a shape in the unexpanded configuration of the elongate body and retains the shape in the radially expanded configuration of the elongate body; and

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

46. The method of claim 45, wherein the plurality of discreet units comprise a plurality of segments having a similar configuration.

47. The method of claim 45, wherein the plurality of discreet units comprise a plurality of stackable components connected in a series.

48. The method of claim 45, further comprising expanding the elongate body from an unexpanded configuration to a radially expanded configuration.

49. The method of claim 45, further comprising removing the brachytherapy applicator from a vaginal canal.

50. The method of claim 45, wherein the radiation therapy is delivered by a radiation source.

51. The method of claim 50, wherein the radiation source comprises a radioactive liquid, an x-ray source, a radiation seed, or combinations thereof.

52. The method of claim 51, 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.

53. The method of claim 52, wherein the radiation source comprises iridium.

54. The method of claim 50, wherein the radiation source is loaded into the plurality of source lumens using an afterloader.

55. The method of claim 50, wherein the radiation source is used to treat a gynecological cancer.

56. The method of claim 55, wherein the gynecological cancer is selected from the group consisting of cervical cancer, endometrial cancer, uterine cancer, ovarian cancer, and vaginal cancer.

57. The method of claim 56, wherein the gynecological cancer is endometrial cancer.

58. The method of claim 57, wherein the radiation source delivers a total radiation dose of 10 Gy to 30 Gy to the target tissue to treat the endometrial cancer.

59. The method of claim 56, wherein the gynecological cancer is cervical cancer.

60. The method of claim 59, wherein the radiation source delivers a total radiation dose of 30 Gy to 45 Gy to the target tissue to treat the cervical cancer.

61. The method of claim 45, wherein the target tissue is the elongate portion of the uterus.

62. The method of claim 45, wherein the target tissue is the cervix.

63. The method of claim 45, wherein the target tissue is tissue of the vaginal wall or vaginal cuff.