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

• US 8,608,632 B1
• Filed: 05/19/2011
• Issued: 12/17/2013
• Est. Priority Date: 07/03/2009
• 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): Lacyk, John
• Assistant Examiner(s): KUHLMAN, CATHERINE BURK
• Application Number:
  US13/111,780
• Time in Patent Office: 943 Days
• Field of Search: 600 1- 8, 2504931-504 H, 252625-647, 378119-144, 424 111- 189, 604 19- 21
• US Class Current: 600/7
• 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: 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:

(a) inserting a cannula into a potential space under a Tenon'"'"'s capsule and above a sclera of the eye of the patient, the cannula configured to have a radionuclide brachytherapy source (RBS) at a treatment position,

(b) observing through a pupil the position of the treatment position in a posterior pole of the eye,

(c) adjusting the cannula that is under the Tenon'"'"'s capsule to achieve fine positioning of the treatment position, the fine positioning is achieved when the treatment position is over a target,

(d) irradiating the target with the RBS.

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. 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 and above a sclera of the eye of the patient;

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

(c) observing through a pupil the position of the distal portion of the cannula in a posterior pole of the eye;

(d) adjusting the cannula that is under the Tenon'"'"'s capsule to achieve fine positioning of the distal portion of the cannula, the fine positioning is achieved when a treatment position of the distal portion is positioned over a target,

(e) advancing a radionuclide brachytherapy source (RBS) through the cannula to the treatment position of the distal portion via a means for advancing a RBS; and

(f) exposing the target to the RBS.

20. 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 via a cannula comprising a radionuclide brachytherapy source (RBS) inserted under Tenon'"'"'s capsule, wherein the target receives a dose rate of greater than about 10 Gy/min, the method further comprises:

(a) observing through a pupil a position of a treatment position in a posterior pole of the eye,

(b) adjusting the cannula that is under the Tenon'"'"'s capsule to achieve fine positioning of the treatment position, the fine positioning is achieved when the treatment position is over a target.