Method of radiation delivery to the eye

• US 6,875,165 B2
• Filed: 02/22/2001
• Issued: 04/05/2005
• Est. Priority Date: 02/22/2001
• Status: Expired due to Fees

• Current Assignee: TDH Partners Incorporated
• Original Assignee: Retinalabs, Inc. (Iridex Corporation)
• Inventors: Hallen, Paul, Dejuan, Eugene Jr.
• Primary Examiner(s): Krishnamurthy, Ramesh
• Application Number:
  US09/790,486
• Publication Number:
  US 20020115902A1
• Time in Patent Office: 1,503 Days
• Field of Search: 128/898, 600/1, 600/2, 600/3, 600/4, 600/5, 600/6, 600/7, 600/8, 604/294
• US Class Current: 600/3
• CPC Class Codes: A61N 2005/1089 Electrons
• CPC Class Codes: A61N 5/1017 Treatment of the eye, e.g. for "macular degeneration"

Abstract

A surgical device for localized delivery of beta radiation in surgical procedures, particularly ophthalmic procedures. Preferred surgical devices include a cannula with a beta radiotherapy emitting material at the distal end of the cannula. The surgical device is particularly suitable for use in the treatment of treat Age Related Macular Degeneration (AMD).

Claims

1. A method for delivery of radiation to a sub-retinal region of the eye, comprising:

detaching a portion of the retina from the sub-retinal region, and

exposing the sub-retinal region to ionizing radiation.

2. A method in accordance with claim 1 wherein the sub-retinal region is exposed to radiation for a time period of about 1 minute or more.

3. A method in accordance with claim 1 wherein the sub-retinal region is exposed to radiation for a time period of about 15 minutes or less.

4. A method in accordance with claim 1 wherein the sub-retinal region is exposed to radiation for a time period between about 1 minute and about 15 minutes.

5. A method in accordance with claim 4 wherein the time period comprises a period between about 2 minutes and about 10 minutes.

6. A method in accordance with claim 1 wherein the ionizing radiation is from a source having an energy sufficient to provide a dose rate of about 50 cGy/sec or more.

7. A method in accordance with claim 1 wherein the ionizing radiation comprises beta radiation.

8. A method in accordance with claim 1 wherein the ionizing radiation comprises a therapeutic radiation component.

9. A method in accordance with claim 8 wherein the therapeutic radiation component comprises essentially pure beta radiation.

10. A method in accordance with claim 1 wherein the sub-retinal region is exposed to sufficient radiation to treat neovascularization.

11. A method in accordance with claim 10 wherein the sub-retinal region comprises blood vessels.

12. A method in accordance with claim 1 wherein the exposing comprises targeting the radiation only at a selected area of the sub-retinal region.

13. A method of claim 12 wherein the selected area comprises blood vessels.

14. A method in accordance with claim 1 wherein the exposing comprises providing an ionizing radiation source and positioning the radiation source spaced from the sub-retinal region.

15. A method in accordance with claim 14 wherein the spacing is about 1 mm or more.

16. A method in accordance with claim 14 wherein the spacing is about 3 mm or less.

17. A method in accordance with claim 14 wherein the spacing is between about 1 mm and about 3 mm.

18. A method in accordance with claim 1 wherein the exposing comprises providing an ionizing radiation source and contacting the sub-retinal region with the radiation source.

19. A method in accordance with claim 1 wherein the exposing comprises providing an ionizing radiation source and positioning the radiation source so that radiation emitted from the radiation source targets only sub-retinal tissue.

20. A method for treating macular degeneration of the eye, comprising:

detaching a portion of the retina of the eye to provide access to a sub-retinal region;

introducing an ionizing radiation source between the retina and the sub-retinal region; and

exposing the sub-retinal region to ionizing radiation from the ionizing radiation source.

21. A method in accordance with claim 20 wherein the sub-retinal region is exposed to the radiation for a time period of about 1 minute or more.

22. A method in accordance with claim 20 wherein the sub-retinal region is exposed to the radiation for a time period of about 15 minutes or less.

23. A method in accordance with claim 20 wherein the sub-retinal region is exposed to the radiation for a time period between about 1 minute and about 15 minutes.

24. A method in accordance with claim 23 wherein the time period comprises a period between about 2 minutes and about 10 minutes.

25. A method in accordance with claim 20 wherein the radiation source has an energy sufficient to provide a dose rate greater than or equal to about 50 cGy/sec.

26. A method in accordance with claim 20 wherein the radiation source comprises a beta radiation emitter.

27. A method in accordance with claim 20 wherein the radiation source comprises a therapeutic radiation component.

28. A method in accordance with claim 27 wherein the therapeutic radiation component comprises essentially a pure beta radiation emitter.

29. A method in accordance with claim 20 wherein the sub-retinal region is exposed to sufficient radiation to treat neovascularization.

30. A method in accordance with claim 29 wherein the sub-retinal region comprises blood vessels.

31. A method in accordance with claim 20 wherein the exposing comprises targeting the radiation at a selected area of the sub-retinal region.

32. A method of claim 31 wherein the selected area comprises blood vessels.

33. A method in accordance with claim 20 further comprising positioning the radiation source spaced from the sub-retinal region.

34. A method in accordance with claim 33 wherein the spacing is about 1 mm or more.

35. A method in accordance with claim 33 wherein the spacing is about 3 mm or less.

36. A method in accordance with claim 33 wherein the spacing is between about 1 mm and about 3 mm.

37. A method in accordance with claim 20 further comprising contacting the sub-retinal region with the radiation source.

38. A method in accordance with claim 20 wherein the exposing comprises positioning the radiation source so that radiation emitted from the radiation source targets only the sub-retinal region.

39. A method in accordance with claim 20 further comprising providing a shield for shielding at least a portion of the radiation source.

40. A method in accordance with claim 39 wherein the shield and the radiation source are relatively movable so as to allow shielding of the radiation source when desired.

41. A method in accordance with claim 20 wherein the radiation source is disposed within an elongated cannula having a distal end and the cannula tapers toward the distal end.

42. A method in accordance with claim 20 wherein the radiation source is disposed within a curved cannula for ease of introducing the radiation source.

43. A method in accordance with claim 20 wherein the radiation source has a length between about 2 mm and about 6 mm.

44. A method for treating the eye, comprising:

detaching the macula from a sub-macular membrane;

introducing an ionizing radiation source into the vitreous of the eye;

directly accessing the sub-macular membrane with the ionizing radiation source; and

targeting sub-macular tissue with ionizing radiation from the ionizing radiation source.

45. A method in accordance with claim 44 wherein the sub-macular tissue is targeted with radiation for a time period of about 1 minute or more.

46. A method in accordance with claim 44 wherein the sub-macular tissue is targeted with radiation for a time period of about 15 minutes or less.

47. A method in accordance with claim 44 wherein the sub-macular tissue is targeted with radiation for a time period between about 1 minute and about 15 minutes.

48. A method in accordance with claim 47 wherein the time period comprises a period between about 2 minutes and 10 minutes.

49. A method in accordance with claim 44 wherein the radiation source has an energy sufficient to provide a dose rate greater than or equal to about 50 cGy/sec.

50. A method in accordance with claim 44 wherein the radiation source is a beta radiation emitter.

51. A method in accordance with claim 44 wherein the radiation source comprises a therapeutic radiation component.

52. A method in accordance with claim 51 wherein the therapeutic radiation component is essentially a pure beta radiation emitter.

53. A method in accordance with claim 44 further comprising positioning the radiation source spaced from the sub-macular tissue.

54. A method in accordance with claim 53 wherein the spacing is about 1 mm or more.

55. A method in accordance with claim 53 wherein the spacing is about 3 mm or less.

56. A method in accordance with claim 53 wherein the spacing is between about 1 mm and about 3 mm.

57. A method in accordance with claim 44 further comprising contacting the sub-macular tissue with the radiation source.

58. A method in accordance with claim 44 wherein the targeting comprises positioning the radiation source so that the radiation emitted from the radiation source targets only the sub-macular tissue.

59. A method in accordance with claim 44 further comprising providing a shield for shielding at least a portion of the radiation source.

60. A method in accordance with claim 59 wherein the shield and the radiation source are relatively movable so as to allow shielding of the radiation source when desired.

61. A method in accordance with claim 44 wherein the radiation source is disposed within an elongated cannula having a distal end and the cannula tapers toward the distal end.

62. A method in accordance with claim 44 wherein the radiation source is disposed within a curved cannula for ease of introducing the radiation source.

63. A method in accordance with claim 44 wherein the radiation source has a length between about 2 mm and about 6 mm.

64. A method for the treatment of wet macular degeneration of the eye, comprising:

providing a radiation source delivery cannula having a distal end and the cannula being tapered toward the distal end;

detaching the macula to provide direct access to a sub-macular membrane comprising blood vessels;

introducing the distal end of the cannula through the sclera into the interior of the eye;

directly accessing the sub-macular membrane with the distal end of the cannula;

providing an ionizing radiation source at the distal end of the cannula;

positioning the ionizing radiation source between about 1 mm and about 3 mm from the blood vessels; and

exposing the blood vessels to sufficient ionizing radiation to treat choroidal neovascularization.

65. A method in accordance with claim 64 wherein the ionizing radiation source is disposed at the proximal end of the cannula before introducing the distal end of the cannula through the sclera into the interior of the eye.