Conformable therapeutic shield for vision and pain

• US 8,926,096 B2
• Filed: 05/14/2013
• Issued: 01/06/2015
• 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, Rimer, Doug, Sutton, Douglas, Carson, Dean, Barragan, Enrique, Clarke, Matt, Tuan, Ashley, Levy, Brian, MacFarlane, K. Angela
• Primary Examiner(s): HASAN, MOHAMMED A
• Application Number:
  US13/894,176
• Publication Number:
  US 20140069438A1
• Time in Patent Office: 602 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 extending along an optical portion of the cornea, the method comprising:

providing a covering comprising;

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

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

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

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

the engagement holds the inner portion on the optical portion of the cornea;

the inner rigidity is from 2.5E-6 Pa-m³ to 6.41E-3 Pa-m³; and

the outer rigidity is no more than 4E-5 Pa-m³.

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 optical portion of the cornea 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 covering is formed from a material selected from silicone, silicone hydrogel, and a combination thereof.

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

and comprises an index of refraction that substantially corresponds to the index of refraction of the cornea.

5. The method of claim 1, wherein the outer portion is configured to center the covering on the cornea.

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 profile, and further comprising deforming the inner portion during the applying of the covering so that the inner radius of curvature of the inner portion substantially conforms to the ablated profile.

7. The method of claim 1, wherein the inner radius of curvature is flatter than the ablated profile 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 substantially conforms to the ablated profile.

8. The method of claim 1, wherein treating comprises treating the eye of the patient following refractive surgery.

9. The method of claim 1, wherein treating comprises treating the eye of the patient following photorefractive keratectomy (“

PRK”

).

10. The method of claim 1, wherein the patient is in a population of patients, each of the population of patients treated with the method, and following treatment with the method, at least about 90% of the population of patients sees 20/40 or better between about 24 hours and 72 hours following PRK.

11. The method of claim 1, wherein treating comprises treating an eye of a patient following laser-assisted in situ keratomileusis (LASIK).

12. The method of claim 1, wherein the patient is in a population of refractive surgery patients after a refractive procedure, and wherein treating the eye of the patient provides a therapy selected from improving post-operative visual acuity, reducing the time to restore full visual acuity following refractive surgery, increasing comfort, improving epithelial healing, reducing edema, reducing light scattering, smoothing the central 2 mm to 3 mm surface of the cornea, and a combination of any of the foregoing in the population of refractive surgery patients, compared to a population of refractive surgery patients undergoing a similar procedure and not wearing the covering.

13. The method of claim 1, wherein when applied to the eye of a patient, the covering seals the cornea.

14. 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 extending along an optical portion of the cornea, the method comprising:

providing a covering comprising;

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

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

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

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

wherein the engagement holds the inner portion on the optical portion of the cornea,

wherein the inner portion is characterized by a thickness from about 50 μ

m to about 250 μ

M.

15. 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 extending along an optical portion of the cornea, the method comprising:

providing a covering comprising;

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

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

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

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

wherein the engagement holds the inner portion on the optical portion of the cornea,

wherein material forming the covering is characterized by a water content of no more than 1%;

an Ionoton Ion Permeability Coefficient of no more than about 2.6×

10<sup>−

6</sup> mm²/min; and

an oxygen permeability Dk of 100 or more.

16. 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 extending along an optical portion of the cornea, the method comprising:

providing a covering comprising;

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

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

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

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

wherein,

the engagement holds the inner portion on the optical portion of the cornea;

inner modulus comprises a modulus in a range from 1 MPa to 35 MPa; and

the outer portion comprises a modulus of no more than 5 MPa.

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

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

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

wherein the inner rigidity 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 over and substantially conforming to the ablated profile and with the outer portion configured to engage the eye along the epithelium, the sclera, or a combination thereof; and

wherein,

the inner portion is centered on an optical portion of the cornea;

the inner portion comprises a modulus from 1 MPa to 35 MPa; and

the outer portion comprises a modulus of no more than 5 MPa.

18. The covering of claim 17, wherein the outer portion is configured to provide engagement with the eye sufficient to resist movement of the inner portion relative to the optical portion of the cornea.

19. The covering of claim 17, 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 optical portion of the cornea 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, the epithelium, or both the sclera and the epithelium of the eye.

20. The covering of claim 17, wherein the inner portion comprises a substantially uniform thickness;

and comprises an index of refraction that substantially corresponds to the index of refraction of the cornea.

21. The covering of claim 17, wherein the covering is formed from a material selected from silicone, silicone hydrogel, and a combination thereof.

22. The covering of claim 17, wherein the inner portion comprises a radius of curvature less than the optical power of the ablated profile, and is configured to deform during the application of the covering so that the inner radius of curvature of the inner portion substantially conforms to the ablated profile.

23. The covering of claim 17, wherein the lower surface of the inner portion comprises an aspherical surface.

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

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

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

wherein the inner rigidity 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 over and substantially conforming to the ablated profile and with the outer portion configured to engage the eye along the epithelium, the sclera, or a combination thereof; and

wherein,

the inner portion is centered on an optical portion of the cornea;

the inner rigidity is from 2.5E-6 Pa-m³ to 6.41E-3 Pa-m³; and

the outer rigidity is no more than 4E-5 Pa-m³.

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

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

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

wherein the inner rigidity 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 over and substantially conforming to the ablated profile and with the outer portion configured to engage the eye along the epithelium, the sclera, or a combination thereof; and

wherein,

the inner portion is centered on an optical portion of the cornea; and

the inner portion is characterized by a thickness from about 50 μ

m to about 250 μ

m.

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

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

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

wherein the inner rigidity 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 over and substantially conforming to the ablated profile and with the outer portion configured to engage the eye along the epithelium, the sclera, or a combination thereof and wherein,

the inner portion is centered on an optical portion of the cornea; and

material forming the covering is characterized by a water content of no more than 1%;

an Ionoton Ion Permeability Coefficient of no more than about 2.6×

10<sup>−

6</sup> mm²/min; and

an oxygen permeability Dk of 100 or more.