Corneal optic formed of degradation resistant polymer

• US 7,976,577 B2
• Filed: 04/14/2005
• Issued: 07/12/2011
• Est. Priority Date: 04/14/2005
• Status: Active Grant

• Current Assignee: Healthcare Royalty Partners II LP (Toronto-Dominion Bank)
• Original Assignee: Acufocus, Inc.
• Inventors: Silvestrini, Thomas A.
• Primary Examiner(s): Matthews; William H.
• Application Number:
  US11/106,043
• Publication Number:
  US 20060235514A1
• Time in Patent Office: 2,280 Days
• Field of Search: 623 41- 513, 623/5.16, 623/6.11, 623/6.14, 623/6.17
• US Class Current: 623/5.13
• CPC Class Codes: A61F 2/14 Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
• CPC Class Codes: A61F 2/145 Corneal inlays, onlays, or lenses for refractive correction
• CPC Class Codes: A61F 2/15 Implant having one or more holes, e.g. for nutrient transport, for facilitating handling
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: A61F 9/00834 Inlays; Onlays; Intraocular lenses [IOL]
• CPC Class Codes: A61L 2430/16 for reconstruction of eye parts, e.g. intraocular lens, cornea
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: C08L 27/16 Homopolymers or copolymers or vinylidene fluoride
• CPC Class Codes: G02C 7/02 Lenses; Lens systems ; Methods of designing lenses
• CPC Class Codes: G02C 7/04 Contact lenses for the eyes disinfection or sterilisation of contact lenses A61L12/00
• CPC Class Codes: G02C 7/165 with stenopaeic apertures

Abstract

Disclosed are mask optics configured to be implanted in a cornea of a patient. In one embodiment, the body of the optic has a light transmitting portion, a light blocking portion disposed about the light transmitting portion, and an outer periphery surrounding the light blocking portion. The optic is adapted to reside between two intracorneal layers of a cornea. The mask optic may be formed from a material comprising a highly fluorinated polymeric material and an opacification agent. Preferred highly fluorinated polymeric materials include polyvinylidene fluoride (PVDF) and preferred opacification agents include carbon. The highly fluorinated polymeric material is preferably resistant to degradation upon exposure to ultraviolet light.

Claims

1. An implantable mask, comprising:

a central optical axis;

an anterior surface extending between an outer periphery and an inner periphery of the mask, the anterior surface configured to reside adjacent a first layer of the stroma of a cornea;

a posterior surface extending between the outer periphery and the inner periphery of the mask, the posterior surface configured to reside adjacent a second layer of the stroma of the cornea;

a mask thickness between the anterior and posterior surfaces of less than about 20 microns;

a substantially opaque annular portion extending between the anterior and posterior surfaces and from the inner periphery toward the outer periphery, the opaque portion configured to substantially prevent transmission of light;

an aperture disposed about the central optical axis and configured to transmit substantially all light directed toward the aperture, the aperture having a dimension generally transverse to the optical axis of about 2.2 millimeters or less, wherein the aperture is surrounded by an inner peripheral region, a hole region, and an outer peripheral region wherein the inner peripheral region is generally concentric with and located between the aperture and the hole region, and the hole region extends from the inner peripheral region to the outer peripheral region; and

a plurality of transport holes having a hole entrance at the anterior surface and extending from the anterior surface to the posterior surface, the hole entrances configured such that sufficient transport of tissue maintaining substances through the mask between the first and second stromal layers is adapted to prevent depletion of tissue maintaining substances that would harm adjacent stromal layers;

wherein substantially all of the holes are located in the hole region and the holes are positioned at irregular locations to minimize the generation of visible artifacts due to the transmission of light through the holes, the inner peripheral region and the outer peripheral region are substantially free of holes, and

the implantable mask is formed from a material comprising a highly fluorinated polymeric material in which the number of carbon-fluorine bonds equals or exceeds the number of carbon-hydrogen bonds in the highly fluorinated polymeric material.

2. The mask of claim 1, wherein the highly fluorinated polymeric material comprises polyvinylidene fluoride (PVDF).

3. The mask of claim 1, wherein the opaque portion comprises an opacification agent selected from the group consisting of organic dyes, organic pigments, inorganic dyes, and inorganic pigments.

4. The mask of claim 3, wherein the opacification agent is carbon.

5. The mask of claim 4, wherein the highly fluorinated polymeric material comprises PVDF.

6. The mask of claim 1, wherein the light transmitting portion comprises the aperture that is sized to transmit a fraction of the light incident on the anterior surface.

7. The mask of claim 6, wherein the aperture is substantially circular.

8. The mask of claim 7, wherein the aperture has a diameter of about 1.8 mm or less.

9. The mask of claim 1, wherein the plurality of holes are configured to substantially eliminate diffraction patterns visible to the patient.

10. The mask of claim 9, wherein a non-uniform spacing is provided between a substantial number of the plurality of holes.

11. The mask of claim 1, wherein a wall thickness is defined as the shortest distance between adjacent holes, the wall thickness being no less than about 20 microns.

12. The mask of claim 1, wherein at least one of the holes extends along a transport axis and is configured to substantially prevent propagation of light from the anterior surface to the posterior surface through the at least one hole.

13. The mask of claim 12, wherein the transport axis of at least one hole is formed at an angle relative to an optic axis of the mask, the angle being large enough to prevent the projection of most of an anterior end of the hole from overlapping a posterior end of the hole.

14. The mask of claim 1, wherein the mask has a substantially constant thickness between the anterior and posterior surfaces.

15. The mask of claim 1, wherein the material comprises about 80-100% highly fluorinated polymeric material.

16. The mask of claim 1, wherein the material comprises about 40-60% highly fluorinated polymeric material.

17. The mask of claim 1, wherein the material further comprises a second material.

18. The mask of claim 17, wherein the second material includes a UV absorbing component.

19. The mask of claim 1, wherein the hole entrances have a transverse dimension of at least about 5 microns.

20. The mask of claim 1, further comprising a lens along the optical axis of the mask.

21. A mask optic comprising:

an aperture having a major axis of about 2.2 mm or less; and

an annular body extending between the aperture and an outer periphery of the mask, the annular body being substantially opaque, wherein the annular body comprises

an anterior surface, a posterior surface, and a plurality of holes extending between the anterior surface and the posterior surface, said holes being positioned at irregular locations to minimize diffraction patterns visible to the patient;

an inner peripheral region and a hole region, the inner peripheral region being located between the aperture and the hole region, wherein the inner peripheral region is substantially devoid of holes;

and wherein the annular body is formed of a material comprising a highly fluorinated polymeric material, wherein the number of carbon-fluorine bonds in the highly fluorinated polymeric material equals or exceeds the number of carbon-hydrogen bonds, and an opacification agent, the opacification agent being present in sufficient quantity to prevent at least a substantial portion of light incident on the anterior surface from being transmitted from the anterior surface to the posterior surface.

22. The mask of claim 21, wherein the highly fluorinated polymeric material comprises polyvinylidene fluoride (PVDF).

23. The mask of claim 21, wherein the opacification agent is selected from the group consisting of organic dyes, organic pigments, inorganic dyes, and inorganic pigments.

24. The mask of claim 23, wherein the opacification agent is carbon.

25. The mask of claim 24, wherein the highly fluorinated polymeric material comprises PVDF.

26. The mask optic of claim 21, wherein the anterior surface is configured to reside adjacent a first intracorneal layer of a cornea, and the posterior surface is configured to reside adjacent a second intracorneal layer.

27. The mask of claim 26, wherein the annular body is adapted to substantially maintain nutrient transport between the first and second intracorneal layers.

28. The mask optic of claim 26, wherein the mask optic does not substantially alter the curvature of a cornea following application of the mask to a cornea.

29. The mask optic of claim 21, wherein the annular body has a substantially constant thickness between the anterior and posterior surfaces.

30. The mask optic of claim 21, wherein the annular body has a thickness between the anterior and posterior surfaces of about 20 microns or less.

31. The mask optic of claim 21, wherein the annular body has a thickness between the anterior and posterior surfaces of about 8 microns.

32. The mask of claim 21, wherein the material comprises about 80-100% highly fluorinated polymeric material.

33. The mask of claim 21, wherein the material comprises about 40-60% highly fluorinated polymeric material.

34. The mask of claim 21, wherein the material further comprises a second material.

35. The mask of claim 34, wherein the second material includes a UV absorbing component.

36. A corneal inlay for treating presbyopia, comprising:

an anterior surface extending between an outer periphery and an inner periphery of the corneal inlay, the anterior surface configured to reside adjacent a first layer of the stroma of a cornea;

a posterior surface extending between the outer periphery and the inner periphery of the corneal inlay, the posterior surface configured to reside adjacent a second layer of the stroma of the cornea;

a corneal inlay thickness between the anterior and posterior surfaces of less than about 20 microns;

a substantially opaque portion extending between the anterior and posterior surfaces and between the outer periphery and the central optical axis, the opaque portion comprising an inner region, an outer region, and a central region disposed between the inner and outer regions, the opaque portion configured to substantially prevent transmission of light;

an aperture disposed about the central optical axis and configured to transmit substantially all incident light, the aperture having a dimension generally transverse to the optical axis, the dimension being about 2.2 millimeters or less;

a plurality of transport holes having a hole entrance at the anterior surface and extending from the anterior surface to the posterior surface, the hole entrances providing an open area of the corneal inlay such that sufficient transport of tissue maintaining substances through the corneal inlay between the first and second stromal layers is enabled to prevent depletion of tissue maintaining substances that would harm adjacent stromal layers;

wherein the holes are positioned at irregular locations between the inner region and the outer region to minimize the generation of visible artifacts due to the transmission of light through the holes;

wherein the inner region and outer region are devoid of open area; and

the corneal inlay is formed from a material comprising a highly fluorinated polymeric material in which the number of carbon-fluorine bonds equals or exceeds the number of carbon-hydrogen bonds in the highly fluorinated polymeric material.