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

• US 9,056,201 B1
• Filed: 08/27/2013
• Issued: 06/16/2015
• Est. Priority Date: 01/07/2008
• Status: Active Grant

• Current Assignee: Salutaris Medical Devices, Inc.
• Original Assignee: Salutaris Medical Devices, Inc.
• Inventors: Hamilton, Russell J., Marsteller, Laurence J., Voevodsky, Michael, Hyman, Samuel, Shriver, Timothy
• Primary Examiner(s): KUHLMAN, CATHERINE BURK
• Application Number:
  US14/011,516
• Time in Patent Office: 658 Days
• Field of Search: 600 1- 8, 2504931-504 H, 252625-647, 378119-144, 424 111- 189, 604 19- 21
• US Class Current: 1/1
• 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 25/0662 Guide tubes
• CPC Class Codes: A61N 2005/1009 Apparatus for loading seeds into magazines or needles
• CPC Class Codes: A61N 5/1007 Arrangements or means for the introduction of sources into the body
• 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 eye (such as the posterior portion of the eye) including cannulas with afterloading systems for introducing radionuclide brachytherapy sources to the cannulas, for example following insertion and positioning of the cannulas. The afterloaders may house the radionuclide brachytherapy source in a vault and connect to the cannula via a guide tube. The afterloaders can advance and retract the source and ensure accurate placement of the source within the cannula.

Claims

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

(a) inserting a cannula (100) into a potential space between a sclera and a Tenon'"'"'s capsule of the eye of the patient, the cannula (100) is operatively connected to an afterloading system (700) having a radionuclide brachytherapy source (RBS) (400);

(b) placing a distal portion (110) of the cannula (100) on or near the sclera and positioning a treatment position (118) of the distal portion (110) of the cannula (100) near the target;

(c) advancing the RBS (400) from the afterloading system (700) through the cannula (100) to the treatment position (118) in the distal portion (110) of the cannula (110);

(d) exposing the target to the RBS (400);

(e) retracting the RBS (400); and

(f) removing the cannula (100).

2. The method of claim 1, wherein the afterloading system (700) comprises:

(a) a vault (710) for storage of the RBS (400), wherein the RBS (400) is attached to an advancing means (722);

(b) a guide tube (720) extending from the vault (710), the guide tube (720) is removably attachable to the cannula (100); and

(c) a source-drive mechanism (730) operatively connected to the advancing means (722), wherein the source-drive mechanism (730) advances the RBS (400) through the guide tube (720) to the treatment position (118) in the cannula (100) and retracts the RBS (400) from the treatment position (118).

3. The method of claim 2, wherein the source-drive mechanism (730) is operatively connected to a computer (740) or other control system.

4. The method of claim 3, wherein the computer (740) or other control system is operatively connected to a control console (744), the control console (744) allows for manipulation of the computer (740) or other control system.

5. The method of claim 1, wherein the afterloading system (700) measures dwell time of the RBS (400) in the treatment position (118).

6. The method of claim 1, wherein the RBS (400) provides a dose rate of between about 1 to 10 Gy/min to the target.

7. The method of claim 1, wherein the cannula (100) comprises a distal portion (110) and a proximal portion (120) connected by an inflection point (130), the distal portion (110) has a radius of curvature between about 9 to 15 mm and an arc length between about 25 to 35 mm and the proximal portion (120) has a radius of curvature between about an inner cross-sectional radius of the cannula (100) and about 1 meter.

8. The method of claim 1, wherein the afterloader system (700) is operatively connected to the cannula (100) after the cannula (100) is positioned in between the Tenon'"'"'s capsule and sclera.

9. The method of claim 1, wherein the afterloader system (700) is operatively connected to the cannula (100) before the cannula is positioned in between the Tenon'"'"'s capsule and sclera.

10. The method of claim 1, wherein both (a) the afterloader system (700) is operatively connected to the cannula (100) and (b) the RBS (400) is advanced before the cannula (100) is positioned in between the Tenon'"'"'s capsule and sclera.

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

(a) inserting a cannula (100) into a potential space between a sclera and a Tenon'"'"'s capsule of the eye of the patient;

(b) placing a distal portion (110) of the cannula (100) on or near the sclera and positioning a treatment position (118) of the distal portion (110) of the cannula (100) near the target;

(c) operatively connecting an afterloading system (700) having a radionuclide brachytherapy source (RBS) (400) to the cannula (100);

(d) advancing the RBS (400) from the afterloading system (700) through the cannula (100) to the treatment position (118) in the distal portion (110) of the cannula (110);

(e) exposing the target to the RBS (400); and

(f) retracting the RBS (400); and

(g) removing cannula (100).

12. The method of claim 11, wherein the afterloading system (700) comprises:

(a) a vault (710) for storage of the RBS (400), wherein the RBS (400) is attached to an advancing means (722);

(b) a guide tube (720) extending from the vault (710), the guide tube (720) is removably attachable to the cannula (100); and

(c) a source-drive mechanism (730) operatively connected to the advancing means (722), wherein the source-drive mechanism (730) advances the RBS (400) through the guide tube (720) to the treatment position (118) in the cannula (100) and retracts the RBS (400) from the treatment position (118).

13. The method of claim 12, wherein the source-drive mechanism (730) is operatively connected to a computer (740) or other control system.

14. The method of claim 13, wherein the computer (740) or other control system is operatively connected to a control console (744), the control console (744) allows for manipulation of the computer (740) or other control system.

15. The method of claim 11, wherein the afterloading system (700) measures dwell time of the RBS (400) in the treatment position (118).

16. The method of claim 11, wherein the RBS (400) provides a dose rate of between about 1 to 10 Gy/min to the target.

17. The method of claim 11, wherein the cannula (100) comprises a distal portion (110) and a proximal portion (120) connected by an inflection point (130), the distal portion (110) has a radius of curvature between about 9 to 15 mm and an arc length between about 25 to 35 mm and the proximal portion (120) has a radius of curvature between about an inner cross-sectional radius of the cannula (100) and about 1 meter.

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

(a) inserting a cannula (100) into a potential space between a sclera and a Tenon'"'"'s capsule of the eye of the patient, the cannula (100) is operatively connected to an afterloading system (700) having a radionuclide brachytherapy source (RBS) (400);

(b) positioning the RBS (400) over the target;

(c) irradiating the target with the RBS (400); and

(d) removing the cannula (100).

19. The method of claim 18, wherein the afterloading system (700) comprises:

(a) a vault (710) for storage of the RBS (400), wherein the RBS (400) is attached to an advancing means (722);

(b) a guide tube (720) extending from the vault (710), the guide tube (720) is removably attachable to the cannula (100); and

(c) a source-drive mechanism (730) operatively connected to the advancing means (722), wherein the source-drive mechanism (730) advances the RBS (400) through the guide tube (720) to a treatment position (118) in the cannula (100).

20. The method of claim 19, wherein the source-drive mechanism (730) is operatively connected to a computer (740) or other control system.