Extraocular device

• US 20060095108A1
• Filed: 05/23/2005
• Published: 05/04/2006
• Est. Priority Date: 11/02/2004
• Status: Active Grant

• Current Assignee: Sydney Biotech Pty Limited
• Original Assignee: Sydney Biotech Pty Limited
• Inventors: Coroneo, Minas Theodore, Chowdhury, Vivek, Morley, John William
• Granted Patent: US 7,877,148 B2
• Time in Patent Office: Days
• US Class Current: 607/141
• CPC Class Codes: A61F 9/08 Devices or methods enabling eye-patients to replace direct visual perception by another kind of perception
• CPC Class Codes: A61N 1/0543 Retinal electrodes
• CPC Class Codes: A61N 1/36046 of the eye

Abstract

A medical device for use on the human eye is described. The device is placed in an extrocular location in a patient and delivers an electrical current that stimulates the retina of patients who are blind or have vision disorders. It has at least one electrode that makes contact with the scleral surface of the eye, the electrode typically being activated by an electrical stimulator. The device produces electrical pulses which pass through the electrodes on the scleral surface of the eye, to activate the retina of the eye, which causes the patient to experience improved vision, visual sensations or the prevention of deterioration of vision. By this means, sight can be restored or improved where patients have disorders of their retina or other parts of their visual system.

Claims

1. An extraocular device comprising:

at least one electrode; and

a stimulator; and

a conducting means for electrically connecting the one or more electrodes to the stimulator;

wherein the electrode is retained on an outer scleral surface of an eye of a subject, the stimulator providing an electrical impulse that travels through the conducting means to said one or more electrodes and the outer scleral surface of the eye, to stimulate retinal tissue in the eye.

2. The device according to claim 1, wherein the one or more electrodes are embedded in a continuous base member housing said one or more electrodes and permitting intimate physical contact between said one or more electrodes and the outer scleral surface of the eye.

3. The device according to claim 2, wherein the base member is retained on the scleral surface by sutures.

4. The device according to claim 2, wherein the base member is retained on the scleral surface by a bioadhesive glue.

5. The device according to claim 1, wherein the one or more electrodes are embedded in separate bases.

6. The device according to claim 5, wherein each base is retained on the scleral surface by sutures.

7. The device according to claim 5, wherein each base is retained on the scleral surface by a bioadhesive glue

8. The device according to claim 2, wherein the base member is shaped to conform to the external scleral surface of the eye of a subject.

9. The device according to claim 8, wherein the base member is shaped to conform to the external scleral surface of the globe of the eye.

10. The device according to claim 8, wherein the shape of the base member retains it on the scleral surface of the eye.

11. The device according to claim 2, wherein the base member includes perforations to decrease the degree of separation of connective tissues from the sclera of the eye.

12. The device according to claim 2, wherein the base member is a strip shape comprising a linear array of electrodes.

13. The device according to claim 2, wherein the base member is shaped to be placed on the scleral surface of the eye without disrupting attachment of the optic nerve.

14. The device according to claim 13, wherein the base member is shaped to be placed on the scleral surface of the eye to fit around further anatomical structures of the eye.

15. The device according to claim 14, wherein the base member is shaped to fit around the attachment of one or more rectus muscles.

16. The device according to claim 15, wherein the base member completely surrounds the sclera of the eye.

17. The device according to claim 2, wherein the base member surrounds a portion of the sclera of the eye.

18. The device according to claim 2, wherein a posterior portion of the base member has an elongate aperture allowing sliding placement of the base member about the optic nerve of the eye.

19. The device according to claim 1, wherein the device has between 1 and 1000 electrodes.

20. The device according to claim 19, wherein each electrode has an independent conducting means, each conducting means being insulated.

21. The device according to claim 1, wherein the stimulator is implanted in the body of the subject.

22. The device according to claim 21, wherein the stimulator is implanted inside the orbit of the subject.

23. The device according to claim 1, wherein the stimulator is located outside of the body, the conducting means exiting the body through a percutaneous connection to meet the stimulator.

24. The device according to claim 1, wherein the stimulator is powered by a battery.

25. The device according to claim 1, wherein the stimulator is powered and controlled by an inductive link from a transmission coil that has been placed outside the body.

26. The device according to claim 2, wherein the base member comprises a biocompatible material.

27. The device according to claim 26, wherein the biocompatible material is a silicone elastomer.

28. The device according to claim 1, wherein the conducting means is insulated with a biocompatible material.

29. The device according to claim 28, wherein the biocompatible material covers a connection between the conducting means and the stimulator.

30. The device according to claim 1, wherein the stimulator is controlled by a preprogrammed sequence of electrical stimulation.

31. The device according to claim 1, wherein the at least one electrode is platinium or a platinium alloy.

32. The device according to claim 1, wherein the electrical impulse provided by the stimulator comprises a monopolar, bipolar or multi-polar electrical impulse.

33. The device according to claim 1, wherein the stimulator provides an electrical impulse that is a constant-current pulse having a duration between 10 μ

s and 10 ms.

34. The device according to claim 1, wherein the stimulator provides an electrical impulse having a current intensity between 1 μ

A and 10 mA.

35. The device according to claim 1, wherein the stimulator provides an electrical impulse that is a biphasic pulse or a monophasic pulse.

36. The device according to claim 1, wherein the stimulator provides an electrical impulse having a frequency between 0.01 Hz and 250 Hz.

37. An extraocular device comprising:

at least one electrode; and

means for electrically stimulating the one or more electrodes

wherein the one or more electrodes are retained on an outer scleral surface of an eye of a subject, with electrical stimulation of the one or more electrodes providing an electrical impulse in the one or more electrodes and the outer scleral surface of the eye, to stimulate retinal tissue in the eye.

38. The device of claim 37, wherein the means for electrically stimulating the electrodes is a laser light source.

39. A method of restoring, improving or preventing deterioration of visual perception in a patient having a visual disorder, the method comprising applying an extraocular electrical impulse to a scleral surface and of an eye and thereby to retinal cells of the eye of the patient.

41. The method of claim 39, wherein the visual disorder is a retinal dystrophy selected from the group comprising retinitis pigmentosa, Usher syndrome, age-related macular degeneration, Stargardt macular dystrophy, Leber congenital amaurosis or Bardet-Biedl syndrome.

42. The method of claim 39, wherein the electrical impulse is delivered to the scleral surface using the device.

40. A method for generating a phosphene in a patient having a visual disorder, the method comprising applying an extraocular electrical impulse to a scleral surface of an eye and thereby to retinal cells of the eye of the patient.

43. An extraocular device or method of restoring, improving or preventing deterioration of visual perception in a patient, or method for generating a phosphene in a patient, substantially as hereinbefore described, with reference to the accompanying Examples and/or Drawings.