Conformable therapeutic shield for vision and pain

• US 9,498,385 B2
• Filed: 10/25/2010
• Issued: 11/22/2016
• Est. Priority Date: 10/23/2009
• Status: Expired due to Fees

• 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): Mack, Ricky
• Assistant Examiner(s): O'Neill, Gary
• Application Number:
  US13/503,842
• Publication Number:
  US 20130070200A1
• Time in Patent Office: 2,220 Days
• Field of Search: 128/858, 351/159.23, 351200-246, 606/5, 623 511- 514
• US Class Current: 1/1
• 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 covering for an eye of a patient, the eye comprising a cornea, an epithelial defect, and an epithelium, the covering comprising:

an inner portion comprising an inner rigidity and an inner modulus, wherein the inner rigidity is characterized by a relative rigidity within a range from about 1×

10<sup>−

4</sup> Pa-m³ to about 5×

10<sup>−

3</sup> Pa-m³ and the inner modulus is within a range from 1 MPa to 35 MPa; and

an outer portion comprising an outer rigidity;

wherein the rigidity of the inner portion is greater than the rigidity of the outer portion;

wherein, when applied to an eye of a patient the outer portion of the covering at least partially conforms to the cornea, and wherein the inner portion provides a chamber between a posterior surface of the inner portion and the cornea in a region of the epithelial defect.

2. The covering of claim 1, wherein the epithelial defect comprises an ablated stroma.

3. The covering of claim 2, wherein the chamber provides an environment configured to promote growth of the epithelium extending over the epithelial defect of at least about 6 mm across within about 2 days of a photorefractive keratectomy (PRK) ablation.

4. The covering of claim 2, wherein the inner portion has an optical power of no more than about +/−

1 D to correct vision of the patient.

5. The covering of claim 2, the patient comprising a member of a population having post photorefractive keratectomy (PRK) surgery eyes, the PRK surgery comprising epithelial removal from a region of the cornea of the eye and ablation of stroma of the cornea underlying the region such that the eye, with an appropriate standard contact lens disposed on the cornea and without the use of the covering, would have visual acuity of worse than 20/40 throughout the period between 24 to 72 hours after the PRK surgery, wherein the covering further comprises:

a concave surface configured for receiving the cornea with the inner portion disposed over the ablated stroma and a convex surface over which an eyelid of the eye will pass without dislodging the curved body from the cornea during blinking of the eye when the concave surface receives the cornea, the covering being transparent and configured to mitigate the epithelial removal so as to improve the visual acuity of at least 40% of the population of eyes therethrough to at least about 20/40 between 24 to 72 hours after the PRK surgery.

6. The covering of claim 1, wherein the inner portion has a relative rigidity within a range from 1×

10<sup>−

4</sup> Pa-m³ to 5×

10<sup>−

4</sup> Pa-m³.

7. The covering of claim 6, wherein the inner portion is characterized by a thickness from 100 μ

m to 250 μ

m.

8. The covering of claim 1, the epithelium of the eye having a defect defining an irregularity on the ablated surface of the stroma and having an irregularity profile with spatial frequencies, the inner portion being configured to cover the irregularity and having an upper surface;

wherein the inner region is configured to provide a low pass filter such that an upper surface profile has spatial frequencies lower than the spatial frequencies of the irregularity profile to correct vision and smooth the irregularity when the outer portion engages the epithelium disposed around the epithelial defect.

9. The covering of claim 1, wherein the inner portion comprises a first curved portion and the outer portion comprises a second curved portion, wherein the first curved portion comprises a first lower surface having a first radius of curvature configured to fit an ablated region of a cornea the eye, the second curved portion comprising a second lower surface having at least one second radius of curvature configured to fit a region of the cornea of the eye without the epithelial defect.

10. The covering of claim 1, wherein the inner portion comprises a thickness and a modulus such that a first area of the covering about 3 mm across deflects about 5 μ

m in response to a first pressure when the first pressure is within a first range from about 200 Pa to about 920 Pa.

11. The covering of claim 1, wherein the outer rigidity comprises a rigidity configured to indent the epithelium when the outer portion is adhered to the cornea.

12. The covering of claim 1, wherein the inner portion comprises silicone and the outer portion comprises silicone.

13. The covering of claim 1, wherein the inner portion comprises a thickness within a range from about 50 μ

m to about 250 μ

m.

14. The covering of claim 1, the outer portion having a plurality of fenestrations extending through a thickness of the covering.

15. The covering of claim 1, the inner portion comprising a first layer of a first material and a second layer of a second material, the first material comprising a first modulus within a first range from about 5 MPa to about 35 MPa, the second material comprising a modulus from about 0.1 MPa to about 5 MPa.

16. A covering to treat an eye of a patient, the eye comprising a cornea and the covering comprising:

a curved body to fit the eye, the body having an inner portion characterized by a modulus within a range from about 4 MPa (Mega Pascal) to about 20 MPa, a relative rigidity within a range from about 1×

10<sup>−

4</sup> Pa-m³ to about 5×

10<sup>−

3</sup> Pa-m³, and the inner modulus is within a range from 1 MPa to 35 MPa; and

when applied to an eye of a patient provides a chamber between a posterior surface of the inner portion and the cornea in a region of an epithelial defect.

17. A covering to treat an eye of a patient, the eye comprising a cornea and the covering comprising:

a curved body to fit the eye, the body comprising an inner portion and an outer portion, the inner portion having a relative rigidity within a range from 1×

10<sup>−

4</sup> Pa-m³ to 5×

10<sup>−

4</sup> Pa-m³ and an inner modulus is within a range from 1 MPa to 35 MPa, the outer portion having a relative rigidity less than the relative rigidity of the inner portion; and

when applied to an eye of a patient the outer portion of the covering provides a chamber between the inner portion and an epithelial defect of the cornea when the covering is positioned on the cornea.

18. The covering of claim 17, wherein the inner portion is characterized by a thickness from 100 μ

m to 250 μ

m.