METHODS AND DEVICES FOR MINIMALLY-INVASIVE EXTRAOCULAR DELIVERY OF RADIATION TO THE POSTERIOR PORTION OF THE EYE

• US 20100004581A1
• Filed: 01/07/2009
• Published: 01/07/2010
• Est. Priority Date: 01/07/2008
• Status: Active Grant

• Current Assignee: Salutaris Medical Devices, Inc.
• Original Assignee: Salutarismd
• Inventors: Hamilton, Russell J., Marsteller, Laurence J., Brigatti, Luca, Voevodsky, Michael
• Granted Patent: US 8,430,804 B2
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61F 9/00 Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand caps with means for protecting the eyes A42B1/018; visors for helmets A42B3/22; retractors A61B17/02; manipulators specially adapted for use in surgery A61B34/70; appliances to aid invalids to move about A61H3/00; exercisers for the eyes A61H5/00; eye baths A61H35/02; sunglasses or goggles having the same features as spectacles G02C
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61N 5/1017 Treatment of the eye, e.g. for "macular degeneration"

Abstract

Methods and devices for minimally-invasive delivery of radiation to the posterior portion of the eye including a cannula comprising a distal portion connected to a proximal portion and a means for advancing a radionuclide brachytherapy source (RBS) toward the tip of the distal portion; a method of introducing radiation to the human eye comprising inserting a cannula between the Tenon'"'"'s capsule and the sclera of the human eye and emitting the radiation from the cannula on an outer surface of said sclera.

Claims

1. A method of irradiating a target of an eye in a patient, said method comprising inserting a cannula into a potential space under a Tenon'"'"'s capsule of the eye of the patient,

the cannula having a radionuclide brachytherapy source (RBS) at a treatment position, whereby the RBS is positioned over the target, and the RBS irradiates the target.

2. The method of claim 1, wherein the Tenon'"'"'s capsule guides insertion of the cannula and provides positioning support for the cannula.

3. The method of claim 1, wherein the target is located on a vitreous side of the eye.

4. The method of claim 1, wherein the RBS is loaded into the cannula before the cannula is inserted.

5. The method of claim 1, wherein the RBS is loaded into the cannula after the cannula is inserted.

6. The method of claim 1, wherein the cannula is a fixed shape cannula.

7. The method of claim 1, wherein the cannula is a flexible cannula, including an endoscope.

8. The method of claim 1, wherein the target is a lesion associated with a retina of the eye.

9. The method of claim 8, wherein the lesion is a neovascular lesion.

10. The method of claim 8, wherein the lesion is a benign growth or a malignant growth.

11. The method of claim 1, wherein the RBS provides a dose rate of between about 0.1 to 1 Gy/min to the target.

12. The method of claim 1, wherein the RBS provides a dose rate of between about 1 to 10 Gy/min to the target.

13. The method of claim 1, wherein the RBS provides a dose rate of between about 10 to 20 Gy/min to the target.

14. The method of claim 1, wherein the RBS provides a dose rate of between about 20 to 30 Gy/min to the target.

15. The method of claim 1, wherein the RBS provides a dose rate of between about 30 to 40 Gy/min to the target.

16. The method of claim 1, wherein the RBS provides a dose rate of between about 40 to 50 Gy/min to the target.

17. The method of claim 1, wherein the RBS provides a dose rate of between about 50 to 75 Gy/min to the target.

18. The method of claim 1, wherein the RBS provides a dose rate of between about 75 to 100 Gy/min to the target.

19. The method of claim 1, wherein the cannula is inserted at a limbus of the eye.

20. The method of claim 1, wherein the cannula is inserted at a point posterior to a limbus of the eye.

21. The method of claim 1 wherein the cannula Is inserted at a point between a limbus and a fornix of the eye.

27. The method of claim 1, wherein the cannula is tapered, having a larger circumferential area at a portion of the cannula that remains in the Tenon'"'"'s capsule upon insertion.

22. A method of irradiating a target of an eye in a patient, said method comprising:

(a) inserting a cannula into a potential space under a Tenon'"'"'s capsule of the eye of the patient;

(b) placing a distal portion of the cannula on or near a sclera behind the target;

(c) advancing a RBS through the cannula to a treatment position of the distal portion via a means for advancing a RBS; and

(d) exposing the target to the RBS.

23. The method of claim 22, wherein the cannula is inserted at a limbus of the eye.

24. The method of claim 22, wherein the cannula is inserted at a point posterior to a limbus of the eye.

25. The method of claim 22, wherein the cannula is inserted at a point between a limbus and a fornix of the eye.

26. The method of claim 22, wherein the distal portion of the cannula is designed for placement around a portion of a globe of an eye;

wherein the distal portion has a radius of curvature between about 9 to 15 mm and an arc length between about 25 to 35 mm;

the cannula further comprising a proximal portion having a radius of curvature between about an inner cross-sectional radius of the cannula and about 1 meter; and

an inflection point which is where the distal portion and the proximal portions connect with each other;

wherein an angle θ

₁ between a line l₃ tangent to the globe of the eye at the inflection point and the proximal portion is between greater than about 0 degrees to about 180 degrees.

28. A hollow fixed shape cannula comprising:

(a) a distal portion for placement around a portion of a globe of an eye;

wherein the distal portion has a radius of curvature between about 9 to 15 mm and an arc length between about 25 to 35 mm; and

(b) a proximal portion having a radius of curvature between about an inner cross-sectional radius of the cannula and about 1 meter; and

(c) an inflection point which is where the distal portion and the proximal portions connect with each other;

wherein an angle θ

₁ between a line l₃ tangent to the globe of the eye at the inflection point and the proximal portion is between greater than about 0 degrees to about 180 degrees.

29. The cannula of claim 28, wherein both the distal portion and the proximal portion lie in a plane P₁.

30. The cannula of claim 28, wherein the distal portion lies in a plane P₁ and the proximal portion lies in a plane P₂.

31. The cannula of claim 28, wherein the distal portion has a radius of curvature of about 12 mm and the distal portion has an arc length of about 30 mm.

32. The cannula of claim 28, wherein the radius of curvature of the distal portion is constant.

33. The cannula of claim 28, wherein the radius of curvature of the distal portion is variable.

34. The cannula of claim 28 having an outer cross sectional shape that is generally round.

35. The cannula of claim 28 having an outer cross sectional shape that is oval, rectangular, egg-shaped or trapezoidal.

36. The cannula of claim 28 having an internal cross sectional shape configured to allow a RBS to glide through.

37. The cannula of claim 28 having an internal cross sectional shape that is generally round.

38. The cannula of claim 28 having an internal cross sectional shape that is oval, rectangular, egg-shaped, or trapezoidal.

39. The cannula of claim 28, wherein the cannula further comprises a handle connected to the proximal portion of the cannula.

40. The cannula of claim 39, wherein the handle comprises a radiation shielding pig for shielding a RBS.

41. The cannula of claim 28, wherein a means of advancing a RBS is disposed within the cannula;

wherein the cannula is for delivering the RBS to the back of the eye.

42. The cannula of claim 41, wherein the means for advancing a RBS toward a tip of the distal portion is selected from the group consisting of a guide wire, a non-wire plunger, an air pressure mechanism, a vacuum mechanism, a hydrostatic pressure mechanism employing a fluid, or a combination thereof.

43. The cannula of claim 28 having a window located on a side of the distal portion, wherein the side is adjacent to the sclera, wherein the window comprises a radiotransparent material.

44. The cannula of claim 28, wherein the cannula further comprises a protuberance disposed on the distal portion, wherein the protuberance is for resting on the limbus of the eye.

46. The cannula of claim 28, wherein a proximal end of the distal portion of the cannula is tapered such that a circumference of the proximal end is larger than a circumference of a distal end of the distal portion.

45. A fixed shape cannula comprising:

(a) a distal portion for placement around a portion of a globe of an eye;

wherein the distal portion has a radius of curvature between about 9 to 15 mm and an arc length between about 25 to 35 mm; and

(b) a proximal portion having a radius of curvature between about an inner cross-sectional radius of the cannula and about 1 meter; and

(c) an inflection point which is where the distal portion and the proximal portions connect with each other;

wherein once a distal end of the distal portion is positioned within the vicinity of the target, the proximal portion is curved away from the visual axis as to allow a user to have direct visual access in the eye.

47. A cannula with a fixed shape, said cannula comprising:

(a) a distal portion for placement around a portion of a globe of an eye; and

(b) a proximal portion connected to the distal portion via an inflection point;

wherein the distal portion has a shape of an arc formed from a connection between two points located on an ellipsoid, the ellipsoid having an x-axis dimension “

a”

, a y-axis dimension “

b,” and

a z-axis dimension “

c,”

wherein “

a”

is between about 0 to 1 meter, “

b”

is between about 0 to 1 meter, and “

c”

is between about 0 to 1 meter;

wherein the proximal portion has a shape of an arc formed from a connection between two points on an ellipsoid, the ellipsoid having an x-axis dimension “

d”

, a y-axis dimension “

e,” and

a z-axis dimension “

f,”

wherein “

d”

is between about 0 to 1 meter, “

e”

is between about 0 to 1 meter, and “

f”

is between about 0 to 1 meter.

wherein an angle θ

₁ between a line l₃ tangent to the globe of the eye at the inflection point and the proximal portion is between greater than about 0 degrees to about 180 degrees.

48. The cannula of claim 47, wherein “

a”

is between about 0 to 50 mm, “

b”

is between about 0 and 50 mm, and “

c”

is between about 0 and 50 mm.

49. The cannula of claim 47, wherein “

d”

is between about 0 to 50 mm, “

e”

is between about 0 and 50 mm, and “

f”

is between about 0 and 50 mm.

50. The cannula of claim 47, wherein the inflection point creates a soft bend between the distal portion and the proximal portion.

51. The cannula of claim 47, wherein the distal portion has an arc length of between about 25 to 35 mm.

52. The cannula of claim 47, wherein the proximal portion has an arc length of between about 10 to 75 mm.

53. A method of delivering a radiation to an eye, said method comprising irradiating a target on a vitreous side of the eye from an outer surface of a sclera, wherein the target receives a dose rate of greater than about 10 Gy/min.

54. The method of claim 53, wherein a hollow cannula is used to deliver a RBS to the sclera region corresponding to the target, the cannula is inserted between a Tenon'"'"'s capsule and a sclera of the eye;

the cannula having a fixed shape, said cannula comprises a distal portion for placement on a portion of the globe of the eye and a proximal portion connected to the distal portion via an inflection point.

55. The method of claim 53, wherein the RBS provides a dose rate of greater than about 11 Gy/min to the target.

56. The method of claim 53, wherein the RBS provides a dose rate of greater than about 12 Gy/min to the target.

57. The method of claim 53, wherein the RBS provides a dose rate of greater than about 13 Gy/min to the target.

58. The method of claim 53, wherein the RBS provides a dose rate of greater than about 14 Gy/min to the target.

59. The method of claim 53, wherein the RBS provides a dose rate of greater than about 15 Gy/min to the target.

60. The method of claim 53, wherein the RBS provides a dose rate between about 15 to 30 Gy/min to the target.

61. The method of claim 53, wherein the RBS provides a dose rate between about 30 to 60 Gy/min to the target.

62. The method of claim 53, wherein the RBS provides a dose rate between about 60 to 100 Gy/min to the target.

63. The method of claim 53, wherein the target is a neovascular tissue

64. The method of claim 53, wherein the target is a macula.

65. The method of claim 53, wherein the target is a benign growth or a malignant growth.

66. A method of irradiating a target associated with a retina of an eye in a patient, said method comprising placing a radionuclide brachytherapy source (“

RBS”

) at or near a sclera portion of the eye that corresponds with the target, the RBS irradiates the target through the sclera, wherein more than 1% of a radiation from the RBS is deposited on a tissue at or beyond a distance of 1 cm from the RBS.

67. The method of claim 66, wherein about 1% to about 15% of the radiation from the RBS is deposited on a tissue at or beyond a distance of 1 cm from the RBS.

68. The method of claim 66, wherein about less than 99 % of the radiation from the RBS is deposited on a tissue at a distance less than 1 cm from the RBS.

69. A method of irradiating a target of an eye in a patient, said method comprising inserting a cannula between a Tenon'"'"'s capsule and a sclera of the eye of the patient,

the cannula has a radionuclide brachytherapy source (“

RBS”

) at a distal end, wherein the RBS is positioned over the sclera portion that corresponds with the target, the RBS irradiates the target through the sclera;

wherein the target receives a dose rate of greater than about 10 Gy/min;

wherein the cannula is a fixed shape cannula; and

wherein the RBS is loaded into the cannula after the cannula is inserted

70. The method of claim 69, wherein the target is a lesion associated with a retina of the eye.

71. The method of claim 70, wherein the lesion is a neovascular lesion.