Corneal inlay with nutrient transport structures

• US 9,427,311 B2
• Filed: 08/13/2010
• Issued: 08/30/2016
• Est. Priority Date: 08/13/2009
• Status: Active Grant

• Current Assignee: Corneagen, Inc. (SightLife, Inc.)
• Original Assignee: Acufocus, Inc.
• Inventors: Christie, Bruce, Peterson, Edward W., van de Pol, Corina
• Primary Examiner(s): Willse, David H
• Application Number:
  US13/390,080
• Publication Number:
  US 20120143325A1
• Time in Patent Office: 2,209 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/1451 Inlays or onlays
• CPC Class Codes: A61F 2/15 Implant having one or more holes, e.g. for nutrient transport, for facilitating handling
• CPC Class Codes: A61F 2250/0024 made from both porous and non-porous parts, e.g. adjacent parts
• CPC Class Codes: G02C 7/046 Contact lenses having an iris pattern
• CPC Class Codes: G02C 7/165 with stenopaeic apertures

Abstract

Corneal inlays and masks and methods of improving vision of a patient with corneal inlays and masks are provided. Masks with an aperture can improve the vision of a patient, such as by increasing the depth of focus of an eye of a patient. For example, a mask can have an annular portion with a relatively low visible light transmission surrounding a relatively high transmission central portion, such as a clear lens or aperture. This provides an annular mask with a small aperture for light to pass through to the retina to increase depth of focus. The mask may also include nutrient transport structures that provide nutrient flow through mask to prevent nutrient depletion. These nutrient transport structures can be configured to concentrate nutrient transmission near a center region of the mask to provide more nutrient flow near the center region.

Claims

1. A corneal inlay comprising:

an anterior surface configured to reside adjacent a first corneal layer;

a posterior surface configured to reside adjacent a second corneal layer;

an opening configured to transmit light therethrough, the opening sized to increase depth of focus sufficiently to treat presbyopia in a human patient;

an outer zone adapted to substantially prevent transmission of light therethrough, the outer zone having nutrient transport structures disposed therein, the outer zone being configured to provide a peak nutrient flow at locations having nutrient transport structures that are spaced away from an inner periphery of the outer zone compared with locations having nutrient transport structures that are adjacent to the inner periphery of the outer zone;

an inner peripheral region disposed between an inner periphery of the corneal inlay and the inner periphery of the outer zone, the inner peripheral region being substantially devoid of holes;

an outer peripheral region disposed between an outer periphery of the outer zone and an outer periphery of the corneal inlay, the outer peripheral region being substantially devoid of holes;

wherein the outer zone comprises a plurality of annular bands, each of the plurality of annular bands having nutrient transport structures, at least some of the plurality of annular bands having different rates of nutrient transport; and

wherein the peak nutrient flow is located in an annular band of the plurality of annular bands that is closer to the inner periphery of the corneal inlay than the outer periphery of the corneal inlay.

2. The corneal inlay of claim 1, wherein the plurality of annular bands comprises a first annular band and a second annular band disposed between the first annular band and the opening;

wherein the first annular band is configured to have enhanced nutrient transport compared with the second annular band; and

wherein the plurality of annular bands further comprises a third annular band disposed between the first annular band and the outer periphery of the corneal inlay, the first annular band having greater nutrient transport than the third annular band.

3. The corneal inlay of claim 1, wherein locations spaced away from the outer periphery of the outer zone have higher porosity than locations adjacent to the outer periphery of the outer zone.

4. The corneal inlay of claim 1, wherein the opening is centrally located, and wherein each of the nutrient transport structures is substantially smaller than the opening.

5. The corneal inlay of claim 1, wherein the peak nutrient flow through the corneal inlay is provided at a location closer to the inner periphery of the outer zone than the outer periphery of the outer zone.

6. The corneal inlay of claim 1, wherein the peak nutrient flow through the corneal inlay is disposed at a location between 20% and 60% of the annular width of the mask from the inner periphery of the corneal inlay.

7. The corneal inlay of claim 1, wherein the peak nutrient flow through the corneal inlay is disposed at a location about 40% of the annular width of the mask from the inner periphery of the corneal inlay.

8. The corneal inlay of claim 1, wherein the inlay comprises a constant thickness.

9. The corneal inlay of claim 1, wherein the outer zone is disposed at least partially within the imaging area of the inlay.

10. The corneal inlay of claim 1, wherein each of the plurality of annular bands comprises a different average nutrient transport structure size.

11. The corneal inlay of claim 1, wherein each of the plurality of annular bands has a same surface area.

12. The corneal inlay of claim 1, wherein the nutrient transport structures in each of the plurality of annular bands are a same size.

13. The corneal inlay of claim 1, wherein each of the plurality of annular bands comprises a same number of nutrient transport structures.

14. The corneal inlay of claim 1, wherein the plurality of bands comprises ten annular bands.

15. The corneal inlay of claim 1, wherein a rate of nutrient transport increases from the inner periphery of the outer zone toward a central region of the outer zone and from the outer periphery of the outer zone toward the central region of the outer zone.

16. A mask configured to be implanted in a cornea of a human patient to increase the depth of focus of the human patient, the mask comprising:

an anterior surface configured to reside adjacent a first corneal layer;

a posterior surface configured to reside adjacent a second corneal layer;

an aperture configured to transmit light therethrough, the aperture sized to increase depth of focus sufficiently to treat presbyopia in the human patient, an inner periphery of the mask forming the aperture;

a substantially opaque portion extending from the aperture toward an outer periphery of the mask, the opaque portion comprising an inner region, an outer region, and a central region disposed radially between the inner and outer regions;

a plurality of holes disposed in the inner, outer and central regions and extending between the anterior surface and the posterior surface;

wherein the central region comprises a first porosity, the inner region comprises a second porosity, the outer region comprises a third porosity, and the first porosity is greater than the second porosity and the third porosity;

wherein the holes in the central region have an average hole size that is greater than an average hole size of the holes in the inner region and an average hole size of the holes in the outer region; and

wherein each of the holes in the central region is closer to the inner periphery of the mask than the outer periphery of the mask.

17. The mask of claim 16, wherein the central region is located at less than about 40 percent of the annular width of the mask from the inner periphery of the mask.

18. The mask of claim 16, wherein a maximum porosity is located at about 40 percent or less of the annular width of the mask from the inner periphery of the mask.

19. The mask of claim 16, wherein the holes are positioned at irregular locations to minimize the generation of visible artifacts due to the transmission of light through the holes.

20. The mask of claim 16, wherein the tendency of the holes to produce visible diffraction patterns is reduced by having a plurality of the holes having a first hole size, shape, or spacing and at least another plurality of the holes with a second hole size, shape, or spacing different from the first hole size, shape, or spacing.

21. The mask of claim 16, further comprising an inner peripheral region disposed between the inner region and the inner periphery of the mask, the inner peripheral region substantially devoid of holes.

22. The mask of claim 16, further comprising an outer peripheral region disposed between the outer region and the outer periphery of the mask, the outer peripheral region substantially devoid of holes.

23. The mask of claim 22, further comprising an inner peripheral region disposed between the inner region and the inner periphery of the mask, the inner peripheral region substantially devoid of holes.

24. The mask of claim 16, wherein the mask comprises a constant thickness.

25. The mask of claim 16, wherein the substantially opaque portion is configured to be at least partially disposed within the imaging area of the mask.

26. The mask of claim 16, wherein the central region is disposed at a location between 20% and 60% of the annular width of the mask from the inner periphery of the mask.

27. The mask of claim 16, wherein each of the holes in the central region is larger than each of the holes in the inner region and the outer region.

28. A mask configured to be implanted in a cornea of a human patient to increase the depth of focus of the human patient, the mask comprising:

an anterior surface configured to reside adjacent a first corneal layer;

a posterior surface configured to reside adjacent a second corneal layer;

an aperture configured to transmit light therethrough, the aperture sized to increase depth of focus sufficiently to treat presbyopia in the human patient, an inner periphery of the mask forming the aperture;

a substantially opaque portion extending from the aperture toward an outer periphery of the mask, the opaque portion comprising an inner region, an outer region, and a central region disposed radially between the inner and outer regions, each of the inner region, central region, and outer region having nutrient transport structures, the inner region being spaced apart from an inner periphery of the substantially opaque portion and the outer region being spaced apart from an outer periphery of the substantially opaque portion;

wherein the central region comprises a first nutrient transport rate between the posterior and anterior surfaces, the inner region comprises a second nutrient transport rate between the posterior and anterior surfaces, the outer region comprises a third nutrient transport rate between the posterior and anterior surfaces, and the first nutrient transport rate is greater than the second and third nutrient transport rates; and

wherein the central region comprises an inner periphery and an outer periphery, a distance between the inner periphery of the mask and the inner periphery of the central region being less than a distance between the outer periphery of the mask and the outer periphery of the central region.

29. The mask of claim 28, wherein the mask comprises a constant thickness.

30. The mask of claim 28, wherein the substantially opaque portion is configured to be at least partially disposed within the imaging area of the mask.

31. The mask of claim 28, wherein the mask is configured to provide no more than 10% glucose depletion at any location along the substantially opaque portion.

32. A method for improving the vision of a human patient, the method comprising:

providing a mask comprising;

an anterior surface configured to reside adjacent a first corneal layer,

a posterior surface configured to reside adjacent a second corneal layer,

an aperture configured to transmit along an optical axis substantially all incident light, the aperture sized to increase depth of focus sufficiently to treat presbyopia in the human patient, an inner periphery of the mask forming the aperture,

a substantially opaque portion extending from the aperture toward an outer periphery of the mask, the opaque portion comprising an inner region, an outer region, and a central region disposed radially between the inner and outer regions, the inner region being spaced apart from an inner periphery of the substantially opaque portion and the outer region being spaced apart from an outer periphery of the substantially opaque portion,

a plurality of holes extending between the anterior surface and the posterior surface, wherein the holes are positioned at locations in the inner, outer and central regions, and the central region comprises a first porosity, the inner region comprises a second porosity, the outer region comprises a third porosity, and the first porosity is greater than the second porosity and the third porosity, wherein each of the holes in the central region is closer to the inner periphery of the mask than the outer periphery of the mask; and

inserting the mask into a cornea.

33. The method of claim 32, wherein the mask is configured to provide no more than 10% glucose depletion at any location along the substantially opaque portion.