Conformable therapeutic shield for vision and pain

• US 8,459,793 B2
• Filed: 09/13/2012
• Issued: 06/11/2013
• Est. Priority Date: 10/23/2009
• Status: Active Grant

• Current Assignee: Journey1, Inc.
• Original Assignee: Nexisvision, Inc.
• Inventors: de Juan, Eugene Jr., Reich, Cary J., Alster, Yair, Macfarlane, K. Angela, Rimer, Doug, Sutton, Douglas, Carson, Dean, Barragan, Enrique, Clarke, Matt, Tuan, Ashley, Levy, Brian
• Primary Examiner(s): HASAN, MOHAMMED A
• Application Number:
  US13/615,111
• Publication Number:
  US 20130025606A1
• Time in Patent Office: 271 Days
• Field of Search: 351200-246
• US Class Current: 351/207
• CPC Class Codes: A61F 13/124 specially adapted for the eyes
• CPC Class Codes: A61F 2/145 Corneal inlays, onlays, or lenses for refractive correction
• CPC Class Codes: A61F 2/147 Implants to be inserted in the stroma for refractive correction, e.g. ring-like implants
• CPC Class Codes: A61F 2009/00853 Laser thermal keratoplasty or radial keratotomy
• CPC Class Codes: A61F 2009/00893 Keratoconus
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• 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: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/008 using laser
• CPC Class Codes: A61F 9/00802 for photoablation
• CPC Class Codes: A61F 9/00804 Refractive treatments
• CPC Class Codes: A61F 9/013 Instruments for compensation of ocular refraction A61F9/008 takes precedence; Instruments for use in cornea removal, for reshaping or performing incisions in the cornea
• CPC Class Codes: A61F 9/0136 Mechanical markers
• CPC Class Codes: A61F 9/04 Eye-masks ; Devices to be worn on the face, not intended for looking through; Eye-pads for sunbathing eye-bandages A61F13/12; protective face-masks A41D13/11; protectors for shampooing A45D
• CPC Class Codes: A61L 2430/16 for reconstruction of eye parts, e.g. intraocular lens, cornea
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: G02C 2202/06 Special ophthalmologic or optometric aspects
• CPC Class Codes: G02C 7/047 Contact lens fitting; Contact lenses for orthokeratology; Contact lenses for specially shaped corneae
• CPC Class Codes: G02C 7/048 Means for stabilising the orientation of lenses in the eye
• CPC Class Codes: G02C 7/049 : Contact lenses having special fitting or structural features achieved by special materials or material structures

Abstract

A conformable covering comprises an outer portion with rigidity to resist movement on the cornea and an inner portion to contact the cornea and provide an environment for epithelial regeneration. The inner portion of the covering can be configured in many ways so as to conform at least partially to an ablated stromal surface so as to correct vision. The conformable inner portion may have at least some rigidity so as to smooth the epithelium such that the epithelium regenerates rapidly and is guided with the covering so as to form a smooth layer for vision. The inner portion may comprise an amount of rigidity within a range from about 1×10-4 Pa*m3 to about 5×10-4 Pa*m3 so as to deflect and conform at least partially to the ablated cornea and smooth an inner portion of the ablation with an amount of pressure when deflected.

Claims

1. A method of treating an eye of a patient, the eye comprising a cornea having an ablated stroma, an epithelium and a sclera, the ablated stroma having an ablated profile, the method comprising:

providing an unflexed covering comprising;

an inner portion having an inner modulus and at least one inner radius of curvature; and

an outer portion having an outer modulus and at least one outer radius of curvature;

wherein the inner modulus is greater than the outer modulus;

applying the covering against the eye so that the covering flexes with the inner portion at least partially disposed along and conforming to the ablated stroma and with the outer portion engaging the eye along the epithelium, the sclera, or a combination thereof; and

resisting movement of the inner portion relative to the eye using the engagement of the outer portion and the eye.

2. The method of claim 1, wherein the inner portion comprises a first curved portion and the outer portion comprises a second curved portion and a third curved portion;

and wherein;

the first curved portion comprises a first lower surface having a first radius of curvature;

the second curved portion comprises a second lower surface having a second radius of curvature; and

the third curved portion comprises a third lower surface having a third radius of curvature; and

further comprising,

inhibiting movement of the inner portion relative to the eye by deforming the third curved portion during the applying of the covering so as to promote motion-inhibiting engagement of the third lower surface against the sclera of the eye.

3. The method of claim 1, wherein the inner portion comprises a substantially uniform thickness.

4. The method of claim 1, wherein inner modulus comprises a modulus in a range from 1 MPa to 35 MPa.

5. The method of claim 1, wherein the inner portion comprises a diameter from about 3 mm to about 8 mm.

6. The method of claim 1, wherein the inner radius of curvature comprises a radius of curvature less than the optical power of the ablated stroma, and further comprising deforming the inner portion during the applying of the covering so that the inner radius of curvature of the inner portion conforms to the ablated stroma.

7. The method of claim 1, wherein the inner radius of curvature is flatter than the ablated stroma by about 1 D to about 3 D, and further comprising deforming the inner portion during the applying of the covering so that the inner radius of curvature of the inner portion conforms to the ablated stroma.

8. The method of claim 1, wherein the outer modulus comprises a modulus of no more than 5 MPa.

9. The method of claim 1, wherein the inner portion comprises an index of refraction that corresponds substantially to the index of refraction of the cornea.

10. The method of claim 1, wherein treating comprises treating an eye of a patient following photorefractive keratectomy (“

PRK”

).

11. The method of claim 10, wherein following treatment with the method, at least about 90% of a population of patients sees 20/40 or better between about 24 hours and 72 hours following PRK.

12. The method of claim 11, further comprising promoting growth of the epithelium over the entire ablated stroma within about 2 days following PRK.

13. The method of claim 1, wherein the inner portion and the outer portion comprise a first material extending along a posterior surface of the covering, and the inner portion comprises a second material disposed anteriorly of the first material, the second material being more rigid than the first material, and further comprising:

promoting an optical shape of an anterior surface of the applied covering over the eye with the second material; and

promoting comfort of the covering by cushioning between the ablated stroma and the first material with the second material.

14. A covering for an eye of a patient, the eye comprising a cornea having an ablated stroma, an unablated stroma, an epithelium, and a sclera, the covering comprising:

an inner portion having an inner modulus and at least one inner radius of curvature; and

an outer portion having an outer modulus and at least one outer radius of curvature;

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

wherein the covering, when applied to the eye, is configured to flex with the inner portion at least partially disposed along and conforming to the ablated stroma and with the outer portion engaging the eye along the epithelium, the sclera, or a combination thereof; and

resisting movement of the inner portion relative to the eye.

15. The covering of claim 14, wherein the outer portion is configured to provide engagement with the eye sufficient to resist movement of the inner portion relative to the eye.

16. The covering of claim 14, wherein the inner portion comprises a first curved portion and the outer portion comprises a second curved and an third curved portion, wherein

the first curved portion comprises a first lower surface having a first radius of curvature;

the second curved portion comprises a second lower surface having a second radius of curvature; and

a third curved portion comprises a third lower surface having a third radius of curvature;

wherein the third curved portion is configured to inhibit movement of the inner portion relative to the eye by deforming the third curved portion during the applying of the covering so as to promote motion-inhibiting engagement of the third lower surface against the sclera of the eye.

17. The covering of claim 16, wherein

the first radius of curvature is configured to at least partially conform to the ablated stroma;

the second radius of curvature is configured to at least partially conform to the unablated stroma and to the epithelium; and

the third radius of curvature is configured to engage the epithelium, the sclera, or a combination thereof;

when the covering is applied to the eye.

18. The covering of claim 16, wherein the third radius of curvature is no more than about 9 mm.

19. The covering of claim 14, wherein the inner portion comprises a substantially uniform thickness.

20. The covering of claim 14, wherein the inner portion comprises a modulus from 1 MPa to 35 MPa.

21. The covering of claim 14, wherein the inner portion comprises a diameter from about 3 mm to about 8 mm.

22. The covering of claim 14, wherein the inner portion comprises a radius of curvature less than the optical power of the ablated stroma, and is configured to deform during the application of the covering so that the inner radius of curvature of the inner portion conforms to the ablated stroma.

23. The covering of claim 14, wherein the inner portion is flatter than the ablated stroma by about 1 D to about 3 D.

24. The covering of claim 14, wherein the outer portion comprises a modulus of no more than 5 MPa.

25. The covering of claim 14, wherein the inner portion comprises an index of refraction that corresponds substantially to the index of refraction of the cornea.

26. The covering of claim 14, wherein the ablated stroma results from photorefractive keratectomy (PRK).

27. The covering of claim 26, wherein the covering promotes growth of the epithelium over the entire ablated stroma within about 2 days following PRK.

28. The covering of claim 14, wherein the inner portion and the outer portion comprise a first material extending along a posterior surface of the covering, and the inner portion comprises a second material disposed anteriorly of the first material, the second material being more rigid than the first material;

wherein the second material is configured to promote a beneficial optical shape of an anterior surface of the applied covering over the eye; and

wherein the first material is configured to promote comfort of the covering by cushioning between the ablated stroma and the first material.

29. The covering of claim 14, wherein the lower surface of the inner portion comprises an aspherical surface.

30. A method of treating an eye of a patient, the eye comprising a cornea having an ablated stroma, an epithelium and a sclera, the ablated stroma having an ablated profile, the method comprising:

providing an unflexed covering comprising;

an inner portion having an inner modulus and at least one inner radius of curvature, wherein the at least one inner radius of curvature comprises a radius of curvature less than a radius of curvature of the ablated stroma, wherein the inner portion comprises a substantially uniform thickness; and

an outer portion having an outer modulus and at least one outer radius of curvature;

wherein the inner modulus is greater than the outer modulus;

applying the covering against the eye so that the covering flexes, with the inner portion at least partially disposed along and deforming so that the at least one inner radius of curvature of the inner portion conforms to the ablated stroma and the outer portion engages the eye along the epithelium, the sclera, or a combination thereof; and

resisting movement of the inner portion relative to the eye using the engagement of the outer portion and the eye.