Eye covering and refractive correction methods for lasik and other applications

• US 10,039,671 B2
• Filed: 10/23/2013
• Issued: 08/07/2018
• Est. Priority Date: 09/11/2012
• Status: Active Grant

• Current Assignee: Nexis Vision Liquidating Trust
• Original Assignee: Nexisvision, Inc.
• Inventors: de Juan, Jr., Eugene, Reich, Cary J., Alster, Yair, Clarke, Matt, Tuan, Kuangmon Ashley, Levy, Brian
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): Kong, Qingjun
• Application Number:
  US14/061,311
• Publication Number:
  US 20140069439A1
• Time in Patent Office: 1,749 Days
• Field of Search: 606 4, 606 5, 623 511- 514
• CPC Class Codes: A61F 13/01025 made of a single layer
• CPC Class Codes: A61F 13/01029 made of multiple layers
• CPC Class Codes: A61F 13/124 specially adapted for the eyes
• CPC Class Codes: A61F 9/008 using laser
• CPC Class Codes: A61F 9/00804 Refractive treatments
• 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: G02C 2202/16 Laminated or compound lenses
• CPC Class Codes: G02C 7/047 Contact lens fitting; Contact lenses for orthokeratology; Contact lenses for specially shaped corneae
• CPC Class Codes: G02C 7/049 Contact lenses having special fitting or structural features achieved by special materials or material structures

Abstract

A method for providing faster visual and functional recovery of patients following refractive surgery such as laser assisted in situ keratomileusis (LASIK) is disclosed. The method comprises providing a covering to the eye of a patient 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.

Claims

1. A method of treating an eye of a patient following refractive surgery, the eye comprising a cornea having an anterior surface, an ablated stroma, and a flap having an anterior surface, the flap surrounded by epithelium and a sclera, the ablated stroma providing the anterior surface of the flap a post-ablation profile when the flap is disposed on the ablated stroma, the method comprising:

providing a covering comprising;

an inner portion characterized by an inner rigidity and a thickness, and comprising an upper surface and a lower surface; and

an outer portion characterized by an outer rigidity, and comprising an upper surface, a lower surface, and a peripheral portion;

wherein the inner rigidity is from 1.2E-6 Pa-m³ to 3.1E-3 Pa-m³ and the outer rigidity is from 5.4E-9 Pa-m³ to 1.5E-4 Pa-m³;

applying the covering to an eye of a patient following the refractive surgery by;

centering the covering on the cornea; and

applying a pressure against the covering to flex the covering against the cornea, wherein,

the covering being applied to the eye, the inner portion of the covering conforms to the optical region of cornea and to the anterior surface of the flap; and

at least a portion of the outer portion of the covering physically contacts the epithelium.

2. The method of claim 1, wherein:

the lower surface of the inner portion is characterized by at least one inner radius of curvature; and

the peripheral portion comprises a lower peripheral surface characterized by at least one peripheral radius of curvature; and

further comprising engaging a peripheral edge of the flap and the adjacent epithelium with the lower peripheral surface of the covering so that the eye views through the flap and the inner portion.

3. The method of claim 2,

wherein the at least one inner radius of curvature comprises a radius of curvature that corresponds to or is less than that associated with the curvature of the ablated stroma;

and

further comprising deforming the inner portion during the applying of the covering so that the upper surface of the inner portion conforms to a shape of the stroma.

4. The method of claim 1,

wherein the outer portion comprises one or more intermediate portions, each of the one or more intermediate portions is independently characterized by an intermediate radius of curvature;

and

further comprising inhibiting movement of the inner portion relative to the eye by deforming at least the peripheral portion during the applying of the covering so as to promote motion-inhibiting engagement of the peripheral portion against the epithelium, the sclera, or a combination thereof, of the eye.

5. The method of claim 1, wherein the inner portion is characterized by a substantially uniform thickness.

6. The method of claim 1, wherein the inner portion is characterized by a shape that does not correct refractive error.

7. The method of claim 1, wherein the inner portion and the outer portion comprise a material selected from silicone, a silicone hydrogel and a combination thereof.

8. The method of claim 1, wherein,

the inner portion comprises a material characterized by an inner modulus;

the outer portion comprises a material characterized by an outer modulus; and

the inner modulus is greater than the outer modulus.

9. The method of claim 1, wherein,

the inner portion comprises a material characterized by an inner modulus;

the outer portion comprises a material characterized by an outer modulus; and

the inner modulus is substantially the same as the outer modulus.

10. The method of claim 1, wherein,

the inner portion is configured to at least partially conform to the post-ablation profile of the flap;

the outer portion comprises at least one intermediate portion configured to at least partially conform to the anterior surface of the cornea; and

the outer portion comprises at least one peripheral portion configured to engage the epithelium, the sclera, or a combination thereof, when the covering is applied to the eye.

11. The method of claim 10, wherein:

a lower surface of the inner portion is characterized by at least one inner radius of curvature from 6 mm to 11 mm;

a lower surface of the at least one intermediate portion is characterized by an intermediate radius of curvature from 7 mm to 9 mm; and

a lower surface of the peripheral portion is characterized by a peripheral radius of curvature from 8 mm to 15 mm.

12. The method of claim 1, wherein,

the lower surface of the inner portion is characterized by an inner radius of curvature that corresponds to or is less than that associated with the curvature of the cornea following refractive surgery;

and

the inner portion is configured to deform during the application of the covering to the eye so that the lower surface of the inner portion at least partially conforms to the anterior surface of the flap.

13. The method of claim 1, wherein,

the inner portion is characterized by a thickness is from 100 μ

m to 150 μ

m.

14. The method of claim 1, wherein the inner portion is characterized by a water content less than 10%.

15. The method of claim 1, wherein the peripheral portion comprises a lower surface characterized by at least one radius of curvature configured to deform or flex to engage the cornea along the epithelium, the sclera, or a combination thereof to resist movement of the inner portion.

16. The method of claim 1, wherein the outer portion comprises at least one intermediate portion between the inner portion and the peripheral portion.

17. The method of claim 16, wherein the intermediate portion is configured to engage the flap so as to hold the flap against the cornea and thereby promote healing.

18. The method of claim 16, wherein,

the at least one intermediate portion is configured to at least partially conform to the cornea and the peripheral portion is configured to engage the cornea so as to prevent movement of the inner portion;

and

both the at least one intermediate portion and the peripheral portion are configured to flex or deform when applied to an eye of the patient.

19. The method of claim 1, wherein, the inner portion is characterized by a curvature that is 1 D to 3 D less than a curvature of the ablated profile.

20. The method of claim 1, wherein, the inner portion of the covering is characterize by at least one inner radius of curvature, wherein the inner radius of curvature is less than a curvature of the ablated profile;

and the outer portion of the covering is characterized by at least one outer radius of curvature, wherein the at least one outer radius of curvature is from OD to 3 D less than a curvature of an outer portion of the anterior surface of the cornea.

21. The method of claim 1, wherein, the inner portion of the covering is characterized by a curvature from 1 D to 2.5 D less than a curvature of the ablated profile;

and the outer portion of the covering comprise an intermediate portion between the inner portion and the peripheral portion, wherein the intermediate portion is characterized by a curvature from 1 D to 2.5 D less than a curvature of an outer portion of the cornea.

22. A method of treating an eye of a patient following refractive surgery, the eye comprising a cornea having an anterior surface, an ablated stroma, and a flap having an anterior surface, the flap surrounded by epithelium and a sclera, the ablated stroma providing the anterior surface of the flap a post-ablation profile when the flap is disposed on the ablated stroma, the method comprising:

providing a covering comprising;

an inner portion characterized by an inner rigidity and a thickness, and comprising an upper surface and a lower surface, wherein the thickness is from 100 μ

m to 150 μ

m and the inner rigidity is from 1.2E-6 Pa-m³ to 3.1E-3 Pa-m³; and

an outer portion characterized by an outer rigidity, and comprising an upper surface, a lower surface, and a peripheral portion;

wherein the inner rigidity is greater than the outer rigidity;

applying the covering to an eye of a patient following the refractive surgery by;

centering the covering on the cornea; and

applying a pressure against the covering to flex the covering against the cornea, wherein,

the covering being applied to the eye, the inner portion of the covering conforms to the optical region of cornea and to the anterior surface of the flap; and

at least a portion of the outer portion of the covering physically contacts the epithelium.

23. A method of treating an eye of a patient following refractive surgery, the eye comprising a cornea having an anterior surface, an ablated stroma, and a flap having an anterior surface, the flap surrounded by epithelium and a sclera, the ablated stroma providing the anterior surface of the flap a post-ablation profile when the flap is disposed on the ablated stroma, the method comprising:

providing a covering comprising;

an inner portion comprising a first lower surface characterized by at least one inner radius of curvature and a material characterized by an inner modulus, wherein the at least one inner radius of curvature comprises a radius of curvature less than a radius of curvature of the post-ablation profile of the anterior surface of the cornea, wherein the inner portion is characterized by a substantially uniform thickness from 100 μ

m to 550 μ

m and the inner portion is characterized by a rigidity from 1.2E-6 Pa-m³ to 3.1E-3 Pa-m³; and

an outer portion characterized by a second lower surface characterized by at least one outer radius of curvature; and

applying the covering to an eye of a patient following the refractive surgery by;

centering the covering on the cornea; and

applying a pressure against the covering to flex the covering against the cornea, wherein,

the covering being applied to the eye, the inner portion of the covering conforms to the optical region of cornea and to the anterior surface of the flap; and

at least a portion of the outer portion of the covering physically contacts the epithelium.