Therapeutic device for pain management and vision

• US 9,943,401 B2
• Filed: 04/06/2009
• Issued: 04/17/2018
• Est. Priority Date: 04/04/2008
• Status: Active Grant

• Current Assignee: Journey1, Inc.
• Original Assignee: Forsight Labs, LLC
• Inventors: de Juan, Jr., Eugene, Reich, Cary J., Boyd, Stephen, Alster, Yair, Sierra, David, Gifford, Hanson S., Alejandro, Jose D., Lindstrom, Richard L., Macfarlane, K. Angela, Sutton, Douglas, Scholl, John Anthony
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US12/384,659
• Publication Number:
  US 20100036488A1
• Time in Patent Office: 3,298 Days
• Field of Search: 35115923
• CPC Class Codes: A61F 2/14 Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
• CPC Class Codes: A61F 2/142 Cornea, e.g. artificial corneae, keratoprostheses or corneal implants for repair of defective corneal tissue
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• 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: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: G02C 7/047 Contact lens fitting; Contact lenses for orthokeratology; Contact lenses for specially shaped corneae

Abstract

A therapeutic lens for the treatment of an epithelial defect comprises a layer of therapeutic material disposed over the stroma and/or Bowman'"'"'s membrane to inhibit water flow from the tear liquid to the stroma and/or Bowman'"'"'s membrane, such that corneal deturgescence can be restored to decrease corneal swelling and light scattering. The layer may cover and protect nerve fibers to decrease pain. The layer may comprise an index of refraction to inhibit light scatter from an anterior surface of the stroma and/or Bowman'"'"'s membrane. The lens may comprise a curved anterior surface that provides functional vision for the patient when the epithelium regenerates. The layer of therapeutic material can be positioned on the eye in many ways, for example with a spray that is cured to adhere the layer to the exposed surface of the stroma and/or Bowman'"'"'s membrane.

Claims

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

placing a covering on the cornea, wherein,

the cornea comprises an epithelium;

the covering, when applied to the cornea, is adhered to the cornea to reduce swelling of the cornea; and

the covering comprises;

an inner portion, wherein the inner portion comprises an inner rigidity, an inner thickness, and an inner durometer; and

an outer portion, wherein the outer portion comprises an outer rigidity;

wherein the inner rigidity is greater than the outer rigidity; and

wherein the inner durometer is within a range of Shore 20 A to Shore 70 A.

2. The method of claim 1 further comprising placing a speculum against the eyelids to expose the eye such that the cornea dries and wherein the covering is placed on the cornea when the speculum is positioned against the eyelids.

3. The method of claim 2 further comprising ablating an exposed stromal tissue of the cornea with a laser beam to correct vision of the eye.

4. The method of claim 3 wherein at least a portion of the covering is placed against the exposed stromal tissue of the dried cornea and wherein the portion of the covering placed against the exposed stromal tissue comprises an amount of hydration that corresponds to less than physiological hydration when the covering is placed against the exposed stromal tissue.

5. The method of claim 1 wherein the covering forms a seal between the cornea and at least a portion of the covering to decrease water flow into the cornea.

6. The method of claim 1 wherein the covering comprises an outer periphery and wherein the epithelium grows over at least a portion of the outer periphery.

7. The method of claim 6 wherein the covering is placed on the epithelium such that the epithelium is disposed under the outer periphery when the epithelium grows over the outer periphery.

8. The method of claim 1 wherein the covering is placed over an epithelial defect of the cornea, the method further comprising:

removing the covering when the epithelial defect is healed.

9. The method of claim 8 wherein the epithelium remains on the cornea and separates from the covering when the covering is removed.

10. The method of claim 9 further comprising providing water to the eye to loosen the covering from the epithelium when the covering is removed.

11. The method of claim 1 wherein the covering comprises a lower surface that is hydrophilic to inhibit sliding.

12. The method of claim 1 wherein the covering comprises a substantially water impermeable material to at least one of deturgesce or inhibit swelling of the cornea when the seal is formed.

13. The method of claim 1 wherein the cornea comprises an epithelial defect and wherein the covering comprises at least one of a lower surface or a lower material configured to suck down against the stroma and adhere to the stroma when the seal is formed and wherein the at least one of the lower surface or lower material is configured to adhere substantially less to the epithelium than to the stroma.

14. The method of claim 13 wherein the at least one of the lower surface or the lower material comprises a hydrophilic lower surface to contact the stroma and wherein the hydrophilic lower surface comprises less adherence to the epithelium than to the stroma when the epithelium covers the epithelial defect.

15. The method of claim 1 wherein the covering comprises a substantially oxygen permeable material.

16. The method of claim 1 wherein the cornea comprises an epithelial defect when the covering is placed on the cornea, the method further comprising removing the covering when the epithelial defect is healed.

17. The method of claim 1 further comprising:

measuring the cornea to determine a characteristic of the covering; and

selecting the covering from among a plurality of coverings in response to the characteristic such that a seal is formed when the covering is placed on the cornea.

18. The method of claim 17 wherein the cornea is measured to determine a curvature of the cornea and the characteristic comprises a radius of curvature of a lower surface of the covering.

19. The method of claim 17 wherein the covering comprises an optical power within a range from about −

5 D to about +5 D.

20. The method of claim 19 wherein the optical power is within a range from about −

1 D to about +1 D.

21. The method of claim 1, wherein,

treating comprises treating an eye of a patient following PRK;

the cornea comprises an epithelial defect and an ablated stoma; and

placing comprises placing the covering over the eye to form a seal with an unablated region of the epithelium.

22. The method of claim 21 wherein,

the covering comprises at least one of a surface or a material to inhibit water flow through the covering and deturgesce the cornea when the seal is formed;

and

the covering comprises at least an inner portion comprising a hydrophilic surface to adhere the covering to the ablated stroma when the seal is formed and to release the covering from the epithelium when the epithelium regenerates and covers the epithelial defect.

23. The method of claim 1, wherein the inner thickness is within a range from 50 μ

m to 200 μ

m.