Corneal denervation for treatment of ocular pain

• US 10,596,038 B2
• Filed: 08/23/2017
• Issued: 03/24/2020
• Est. Priority Date: 10/23/2009
• Status: Active Grant

• Current Assignee: Journey1, Inc.
• Original Assignee: Journey1, Inc.
• Inventors: Alster, Yair, Gifford, Hanson S., Reich, Cary J., De Juan, Jr., Eugene, Scholl, John A., Alejandro, Jose D., Sutton, Douglas, Refaeli, Omer
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US15/684,010
• Publication Number:
  US 20180000639A1
• Time in Patent Office: 944 Days
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61F 2009/00872 Cornea
• CPC Class Codes: A61F 2009/00893 Keratoconus
• CPC Class Codes: A61F 9/0079 using non-laser electromagnetic radiation, e.g. non-coherent light or microwaves
• CPC Class Codes: A61F 9/008 using laser
• CPC Class Codes: A61F 9/00804 Refractive treatments
• CPC Class Codes: A61F 9/009 Auxiliary devices making contact with the eyeball and coupling in laser light, e.g. goniolenses apparatus for eye examination A61B3/0008
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36046 of the eye
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

Methods and apparatus for the treatment of the eye to reduce pain can treat at least an outer region of the tissue so as to denervate nerves extending into the inner region and reduce the pain. For example, the cornea of the eye may comprise an inner region having an epithelial defect, and an outer portion of the cornea can be treated to reduce pain of the epithelial defect. The outer portion of the cornea can be treated to denervate nerves extending from the outer portion to the inner portion. The outer portion can be treated in many ways to denervate the nerve, for example with one or more of heat, cold or a denervating noxious substance such as capsaicin. The denervation of the nerve can be reversible, such that corneal innervation can return following treatment.

Claims

1. A method of treating a cornea of an eye, comprising:

applying an apparatus to an anterior surface of a cornea, wherein the cornea comprises an epithelium, a stroma, an inner portion and an outer portion; and

applying energy from the apparatus to denervate a region of the cornea corresponding to a denervation treatment profile,

wherein denervating comprises severing axons in the region of the cornea.

2. The method of claim 1, wherein treating comprises denervating the inner portion of the cornea.

3. The method of claim 1, wherein the apparatus comprises an annular ring configured to contact the cornea.

4. The method of claim 1, wherein the energy comprises radiofrequency energy, heating, cooling, light, or ultrasound.

5. The method of claim 1, wherein applying energy comprises applying energy to the outer portion according to the denervation treatment profile.

6. The method of claim 1, wherein denervation comprises severing axons with the nerve sheath intact.

7. The method of claim 1, wherein the denervation treatment profile comprises an annular denervation treatment profile.

8. The method of claim 1, wherein the denervation treatment profile corresponds to a depth within the cornea.

9. The method of claim 1, wherein the denervation treatment profile is localized substantially to the stroma.

10. The method of claim 1, wherein the denervation treatment profile encompasses nerve bundles.

11. The method of claim 1, wherein the denervation treatment profile is determined by the intensity of the energy, the duration the energy is applied, or a combination thereof.

12. The method of claim 1, wherein the denervation treatment profile is localized substantially to the epithelial layer.

13. The method of claim 1, wherein the treatment profile is configured to denervate nerves at a predetermined depth within the cornea.

14. The method of claim 1, wherein the treatment profile is configured to denervate nerves of the epithelium without substantial penetration to nerves below a Bowman'"'"'s membrane of the eye, or to denervate nerves extending along lamella of a stroma disposed between the epithelium and an endothelium of the outer portion.

15. The method of claim 1, wherein the treatment profile is configured to denervate nerves in the outer portion of the cornea without causing substantial damage to endothelial cells.

16. A method of treating a cornea of an eye, comprising:

applying an apparatus to an anterior surface of a cornea, wherein the cornea comprises an epithelium, a stroma, an inner portion and an outer portion; and

applying energy from the apparatus to denervate a region of the cornea corresponding to a

denervation treatment profile,

wherein denervation comprises stunning corneal nerves, increasing the threshold of the corneal nerves, inhibiting corneal nerve transmission, blocking the corneal nerve transmission, or a combination of any of the foregoing.

17. A method of treating a cornea of an eye, comprising:

applying an apparatus to an anterior surface of a cornea, wherein the cornea comprises an epithelium, a stroma, an inner portion and an outer portion; and

applying energy from the apparatus to denervate a region of the cornea corresponding to a

denervation treatment profile,

wherein denervation comprises denervating nerves without causing substantial damage to the endothelium.