Methods and devices for minimally-invasive extraocular delivery of radiation to the posterior portion of the eye

• US 8,430,804 B2
• Filed: 01/07/2009
• Issued: 04/30/2013
• Est. Priority Date: 01/07/2008
• Status: Active Grant

• Current Assignee: Salutaris Medical Devices, Inc.
• Original Assignee: Salutaris Medical Devices, Inc.
• Inventors: Brigatti, Luca, Hamilton, Russell J., Marsteller, Laurence J., Voevodsky, Michael
• Primary Examiner(s): Matthews, Christine
• Assistant Examiner(s): KUHLMAN, CATHERINE BURK
• Application Number:
  US12/350,079
• Publication Number:
  US 20100004581A1
• Time in Patent Office: 1,574 Days
• Field of Search: 600 1- 8, 604 19- 21, 424 111- 189
• US Class Current: 600/3
• 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, wherein the target is a neovascular lesion and is located on a vitreous side of the eye, said method comprising inserting a cannula having a radionuclide brachytherapy source (RBS), into a potential space between a sclera and a Tenon'"'"'s capsule of the eye of the patient, positioning the RBS over the target, irradiating the target, and removing the RBS and cannula.

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 RBS is loaded into the cannula before the cannula is inserted.

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

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

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

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

8. The method of claim 7, wherein the lesion is a benign growth or a malignant growth.

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

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

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

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

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

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

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

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

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

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

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

20. 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.

21. A method of irradiating a target of an eye in a patient, wherein the target is a neovascular lesion and is located on a vitreous side of the eye, said method comprising:

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

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

(c) advancing a radionuclide brachytherapy source (RBS) through the cannula to a treatment position adjacent the distal portion of the cannula;

(d) exposing the target to the RBS; and

(e) removing the RBS and cannula.

22. The method of claim 21, wherein the cannula is inserted at a limbus of the eye.

23. The method of claim 21, wherein the cannula is inserted at a point posterior to a limbus of the eye.

24. The method of claim 21, wherein the cannula is inserted at a point between a limbus and a fornix of the eye.

25. The method of claim 21, 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 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.

26. A method of delivering a radiation to an eye using a cannula having a radionuclide brachytherapy source (RBS) adjacent an end thereof, said method comprising irradiating a target on a neovascular lesion on a vitreous side of the eye from a location between an outer surface of a sclera and a Tenon'"'"'s capsule of the eye, wherein a hollow cannula is used to deliver a RBS to a 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, and wherein the target receives a dose rate of greater than about 10 Gy/min.

27. The method of claim 26, wherein the RBS provides a dose rate of greater than about 11 Gy/min to the target.

28. The method of claim 26, wherein the RBS provides a dose rate of greater than about 12 Gy/min to the target.

29. The method of claim 26, wherein the RBS provides a dose rate of greater than about 13 Gy/min to the target.

30. The method of claim 26, wherein the RBS provides a dose rate of greater than about 14 Gy/min to the target.

31. The method of claim 26, wherein the RBS provides a dose rate of greater than about 15 Gy/min to the target.

32. The method of claim 26, wherein the RBS provides a dose rate between about 15 to 30 Gy/min to the target.

33. The method of claim 26, wherein the RBS provides a dose rate between about 30 to 60 Gy/min to the target.

34. The method of claim 26, wherein the RBS provides a dose rate between about 60 to 100 Gy/min to the target.

35. The method of claim 26, wherein the target is a macula.

36. The method of claim 26, wherein the target is a benign growth or a malignant growth.

37. A method of irradiating a target of an eye in a patient, wherein the target is adjacent the macula and is located on a vitreous side of the eye, 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.

38. The method of claim 37, wherein the target is a lesion associated with a retina of the eye.

39. The method of claim 38, wherein the lesion is a neovascular lesion.