Inserting lenses into corneal epithelial pockets to improve vision

• US 7,828,844 B2
• Filed: 09/12/2003
• Issued: 11/09/2010
• Est. Priority Date: 09/13/2002
• Status: Expired due to Fees

• Current Assignee: Forsight Labs, LLC
• Original Assignee: Forsight Labs, LLC
• Inventors: Hollrigel, Greg S., Back, Arthur, Marmo, J. Christopher
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US10/661,400
• Publication Number:
  US 20050080484A1
• Time in Patent Office: 2,615 Days
• Field of Search: 623/5.11, 623/5.14, 623/5.16, 623/906
• US Class Current: 623/5.11
• CPC Class Codes: A61F 2/145 Corneal inlays, onlays, or lenses for refractive correction
• CPC Class Codes: A61F 2/1453 Corneal lenses connected to distinct attachment means
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• 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: A61L 2430/16 for reconstruction of eye parts, e.g. intraocular lens, cornea
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3813 Epithelial cells, e.g. keratinocytes, urothelial cells
• CPC Class Codes: A61L 27/3839 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3895 using specific culture conditions, e.g. stimulating differentiation of stem cells, pulsatile flow conditions
• CPC Class Codes: Y10S 623/906 Corneal

Abstract

Methods of correcting vision are described. The methods include inserting a lens into a corneal epithelial pocket or a pocket created between a corneal epithelium of an eye of a patient and Bowman'"'"'s membrane of the eye. A lens is inserted into the pocket to correct vision. Certain methods include one or more steps of cooling the corneal epithelium, and applying an aqueous liquid to the eye. The lenses that are inserted into the pocket can include collagen, including recombinant collagen, synthetic polymeric materials, and combinations thereof.

Claims

1. A method for vision correction of an eye having a corneal epithelium and a Bowman'"'"'s membrane disposed under the corneal epithelium, the method comprising:

separating the corneal epithelium from the Bowman'"'"'s membrane to form an epithelial cell layer separated from the Bowman'"'"'s membrane and a pocket extending between the epithelial cell layer and the Bowman'"'"'s membrane, the epithelial cell layer separated from the Bowman'"'"'s membrane having a periphery substantially attached to the Bowman'"'"'s membrane to fix a lens to the eye; and

inserting the lens into the pocket between the epithelial cell layer and the Bowman'"'"'s membrane of the eye, such that the lens is substantially fixed on the Bowman'"'"'s membrane of the eye with the epithelial cell layer.

2. The method of claim 1, further comprising forming an incision in the epithelium to create the pocket.

3. The method of claim 2, wherein the step of forming an incision includes forming an incision on an approximate nasal portion, a temporal portion, a superior portion, and/or inferior portion of the epithelium.

4. The method of claim 2, wherein the step of forming an incision includes forming an incision on an approximate medial portion of the epithelium to form a first pocket and a second pocket, each pocket sized to accommodate a portion of the lens.

5. The method of claim 1, further comprising deforming the lens prior to the inserting step.

6. The method of claim 1, further comprising removing the lens from the eye, and inserting another vision correcting lens into the pocket.

7. The method of claim 1, wherein the lens comprises a synthetic material.

8. The method of claim 1, wherein the lens comprises a synthetic polymeric material.

9. The method of claim 1, further comprising forming a plurality of incisions in the epithelium.

10. The method of claim 1, wherein the inserting step occurs substantially without damaging Bowman'"'"'s membrane.

11. The method of claim 1, wherein the inserting step occurs substantially without damaging a portion of a stroma of the cornea of the eye.

12. The method of claim 1, further comprising administering a healing agent to the eye in an amount effective to promote healing of the epithelium.

13. The method of claim 1, further comprising forming an incision in the epithelium, and passing the lens through the incision.

14. The method of claim 13, wherein the epithelium is lifted using a vacuum.

15. The method of claim 13, wherein the epithelium is lifted by delivering a fluid beneath the epithelium.

16. The method of claim 1, further comprising applying an effective amount of an epithelium preserving agent to the epithelium.

17. The method of claim 16, wherein the epithelium preserving agent includes a gel.

18. The method of claim 16 wherein the epithelium preserving agent comprises a component selected from the group consisting of water soluble polymeric materials, water swellable polymeric materials and mixtures thereof.

19. The method of claim 16, wherein the epithelium preserving agent includes at least one cellulosic component.

20. The method of claim 19, wherein the epithelium preserving agent includes hydroxymethylcellulose.

21. The method of claim 1, further comprising creating the pocket using a sharp blade to slice through the epithelium.

22. The method of claim 1, further comprising creating the pocket using a blunt instrument to separate the epithelium substantially without slicing the epithelium.

23. The method of claim 1, wherein the creating step comprises using a microkeratome.

24. The method of claim 22, wherein the blunt instrument is a spatula or a wire.

25. The method of claim 15, wherein the fluid includes sodium chloride or other tonicity agent.

26. The method of claim 15, wherein the fluid is a hypertonic aqueous liquid.

27. The method of claim 1, further comprising:

applying a liquid to the corneal epithelium, the liquid being effective in loosening the epithelium substantially without killing epithelial cells;

treating the epithelium to provide or maintain the epithelium in a moisturized state;

wherein the epithelial cell layer is separated by raising a portion of the loosened, moisturized epithelium from the Bowman'"'"'s membrane located below the epithelium; and

forming one or more incisions in the raised portion of the epithelium to accommodate the lens.

28. The method of claim 27, wherein the steps occur sequentially.

29. The method of claim 27, further comprising, prior to the forming step, delivering a substance beneath the raised portion of the corneal epithelium to maintain a spaced apart relationship between the epithelium and Bowman'"'"'s membrane.

30. The method of claim 27, wherein the liquid that is applied includes sodium chloride or other tonicity agent.

31. The method of claim 27 wherein the liquid that is applied is a hypertonic aqueous liquid.

32. The method of claim 27, further comprising scoring a portion of the epithelium to create an epithelial defect prior to applying the liquid.

33. The method of claim 27, wherein the treating step comprises applying a gel to the epithelium.

34. The method of claim 33, wherein the gel-containing composition comprises a component selected from the group consisting of water soluble polymeric materials, water swellable polymeric materials and mixtures thereof.

35. The method of claim 33, wherein the gel-containing composition comprises at least one cellulosic component.

36. The method of claim 35 wherein the gel-containing composition comprises hydroxymethylcellulose.

37. The method of claim 27, wherein the step of separating the epithelium from the Bowman'"'"'s membrane includes using a blunt dissection apparatus.

38. The method of claim 27, wherein the substance that is delivered to beneath the raised portion of the epithelium is a gel-containing composition.

39. The method of claim 38, wherein the gel-containing composition comprises a component selected from the group consisting of water soluble polymeric materials, water swellable polymeric materials and mixtures thereof.

40. The method of claim 38, wherein the gel-containing composition comprises a cellulosic component.

41. The method of claim 38, wherein the gel-containing composition includes hydroxymethylcellulose.

42. The method of claim 27, wherein the forming step comprises forming a plurality of incisions in the raised portion of the epithelium.

43. The method of claim 1, further comprising administering a moisturizer to the epithelium effective in providing and/or maintaining the epithelium in a moisturized state.

44. The method of claim 1, further comprising:

applying a liquid to the corneal epithelium, the liquid being effective in loosening the epithelium substantially without killing epithelial cells;

wherein the epithelial cell layer is separated by raising a portion of the loosened epithelium from the Bowman'"'"'s membrane located below the epithelium;

delivering a substance beneath the raised portion of the epithelium to maintain a spaced apart relationship between the epithelium and the surface of the cornea;

forming one or more elongated incisions in the raised portion of the epithelium to accommodate the lens.

45. The method of claim 44, wherein the liquid that is applied includes sodium chloride or other tonicity agent.

46. The method of claim 44, wherein the liquid that is applied is a hypertonic aqueous liquid.

47. The method of claim 44, further comprising scoring a portion of the epithelium to create an epithelial defect prior to applying the liquid.

48. The method of claim 44, wherein the step of raising a portion of the epithelium includes using a vacuum.

49. The method of claim 44, wherein the step of separating the epithelium from the surface of the cornea includes using a blunt dissection apparatus.

50. The method of claim 49, wherein the blunt dissection apparatus comprises a spatula or a wire.

51. The method of claim 44, wherein the substance that is delivered to beneath the raised portion of the epithelium is a gel-containing composition.

52. The method of claim 51, wherein the gel-containing composition comprises a component selected from the group consisting of water soluble polymeric materials, water swellable polymeric materials and mixtures thereof.

53. The method of claim 51, wherein the gel-containing composition comprises at least one cellulosic component.

54. The method of claim 53, wherein the gel-containing composition includes hydroxymethylcellulose.

55. The method of claim 44, wherein the one or more incisions are formed using a microkeratome.

56. The method of claim 44, wherein the forming step comprises forming a plurality of incisions in the raised portion of the epithelium.

57. The method of claim 44, further comprising applying a healing agent to the epithelium at the one or more incisions.

58. The method of claim 1, further comprising applying an aqueous fluid to the eye.

59. The method of claim 58, wherein the aqueous fluid is selected from the group consisting of water and saline.

60. The method of claim 58, further comprising cooling the corneal epithelium.

61. The method of claim 1, wherein a biodegradable adhesive is applied to the epithelium and wherein the lens forms a natural bond to the Bowman'"'"'s membrane.

62. The method of claim 1, wherein the lens comprises a cellular attachment element.

63. The method of claim 1, wherein the lens comprises an agent selected from the group consisting of growth factors, extracellular matrix proteins, fragments thereof, and combinations thereof.

64. The method of claim 1, wherein the lens comprises collagen.

65. The method of claim 1, wherein the lens comprises recombinant collagen.

66. The method of claim 1, wherein the lens comprises collagen and a synthetic polymeric material.

67. The method of claim 1, wherein the lens is free of donor corneal tissue.

68. The method of claim 1, wherein the lens comprises collagen Type I.

69. The method of claim 1, wherein the lens comprises collagen other than collagen Type I.

70. The method of claim 27, wherein the forming step comprises applying a fluid to the corneal epithelium.

71. The method of claim 27, wherein the forming step comprises applying a chemical to the corneal epithelium.

98. The method of claim 1 wherein the lens forms a natural bond with the Bowman'"'"'s membrane to hold the lens in place.

99. The method of claim 98 wherein an adhesive is applied to the epithelium.

100. The method of claim 1 further comprising forming an incision in the epithelium and wherein the lens is inserted into the pocket through the incision.

101. The method of claim 100 wherein the incision comprises an incision size and the pocket comprises a pocket size, and wherein the incision size is less than the pocket size.

102. The method of claim 101 wherein the lens is deformed to fit through the incision when the lens is inserted into the pocket and wherein the lens is at least one of folded or rolled to deform the lens to fit through the incision.

103. The method of claim 1 wherein the lens comprises an edge configured to promote epithelial cell migration over the edge of the lens.

104. The method of claim 103 wherein the edge comprise a thickness less than about 30 micrometers to promote epithelial cell migration over the edge of the lens.

105. The method of claim 103 wherein the lens comprises an anterior surface and a posterior surface, the edge comprising a rounded portion of the anterior surface and an apex along the posterior surface to promote the epithelial cell migration.

106. The method of claim 1 wherein the lens is configured to correct astigmatism of the eye and wherein the lens is held in a fixed position by the epithelium to maintain an orientation of the lens on the eye.

107. The method of claim 1 wherein the lens is configured to correct aberration of the eye and wherein the lens is held in a fixed position by the epithelium to maintain an orientation of the lens on the eye.

108. The method of claim 107 wherein the aberration comprises an asymmetrical higher-order wavefront aberration and wherein the lens is configured to maintain a desired orientation to correct the higher-order asymmetrical wavefront aberration.

109. The method of claim 1 wherein the lens is configured to correct presbyopia of the eye and wherein the lens is held in a fixed position by the epithelium to maintain correct the presbyopia of the eye.

72. A method for vision correction of an eye having a corneal epithelium and a Bowman'"'"'s membrane disposed under the corneal epithelium, the method comprising:

cooling the corneal epithelium of eye;

separating the corneal epithelium from the Bowman'"'"'s membrane to form an epithelial cell layer separated from the Bowman'"'"'s membrane and a pocket extending between the epithelial cell layer and the Bowman'"'"'s membrane, the epithelial cell layer separated from the Bowman'"'"'s membrane having a periphery substantially attached to the Bowman'"'"'s membrane to fix a lens to the eye with the corneal epithelial layer; and

inserting a lens into the pocket between the epithelial cell layer and the Bowman'"'"'s membrane of the eye, such that the lens is substantially fixed on the Bowman'"'"'s membrane with the epithelial cell layer.

73. The method of claim 72, wherein the cooling is effective in protecting corneal epithelial cells of the corneal epithelium from cellular injury resulting from creation of the pocket.

74. The method of claim 72, wherein the pocket is created using a separator, and the separator is cooled to cool the corneal epithelium.

75. The method of claim 72, further comprising applying an aqueous liquid to the eye.

76. The method of claim 75, wherein the aqueous liquid is selected from the group consisting of water and saline.

77. The method of claim 72, wherein a biodegradable adhesive is applied to the epithelium and wherein the lens forms a natural bond to the Bowman'"'"'s membrane.

78. The method of claim 72, wherein the lens comprises collagen.

79. The method of claim 72, wherein the lens comprises recombinant collagen.

80. The method of claim 72, wherein the lens comprises a synthetic polymeric material.

81. The method of claim 72, wherein the lens comprises collagen and a synthetic polymeric material.

82. The method of claim 72, wherein the lens is free of donor corneal tissue.

83. The method of claim 72, wherein the lens comprises collagen Type I.

84. The method of claim 72, wherein the lens comprises collagen other than collagen Type I.

85. The method of claim 72, wherein the lens comprises a cellular attachment element.

86. The method of claim 72, wherein the lens comprises an agent selected from the group consisting of growth factors, extracellular matrix proteins, fragments thereof, and combinations thereof.

87. The method of claim 72, further comprising creating the pocket using a microkeratome.

88. A method for vision correction of an eye having a corneal epithelium and a Bowman'"'"'s membrane disposed under the corneal epithelium, the method comprising:

separating the corneal epithelium from the Bowman'"'"'s membrane to form an epithelial cell layer separated from the Bowman'"'"'s membrane and a pocket extending between the epithelial cell layer and the Bowman'"'"'s membrane, the epithelial cell layer separated from the Bowman'"'"'s membrane having a periphery substantially attached to the Bowman'"'"'s membrane to fix a lens on the Bowman'"'"'s membrane with the corneal epithelial layer;

inserting the lens into the pocket between the epithelial cell layer and the Bowman'"'"'s membrane of the eye, such that the lens is substantially fixed to the eye with the epithelial cell layer; and

applying an effective amount of an epithelium preserving agent to the epithelium, wherein the epithelium preserving agent includes at least one cellulosic component.

89. The method of claim 88, wherein the epithelium preserving agent includes hydroxymethylcellulose.

90. A method for vision correction of an eye having a corneal epithelium and a Bowman'"'"'s membrane disposed under the corneal epithelium, the method, comprising:

applying a liquid to the corneal epithelium of the eye, the liquid being effective in loosening the epithelium substantially without killing epithelial cells;

treating the epithelium to provide or maintain the epithelium in a moisturized state, wherein the treating step comprises applying a gel containing composition to the epithelium;

raising a portion of the loosened, moisturized epithelium to separate the portion of the corneal epithelium from the Bowman'"'"'s membrane to form an epithelial cell layer separated from the Bowman'"'"'s membrane and a pocket, the pocket extending between the epithelial cell layer and the Bowman'"'"'s membrane, the epithelial cell layer separated from the Bowman'"'"'s membrane having a periphery substantially attached to the Bowman'"'"'s membrane to fix a lens to the eye;

forming one or more incisions in the raised portion of the epithelium to access the pocket between the corneal epithelium and Bowman'"'"'s membrane; and

inserting a lens into the pocket through the one or more incisions such that the lens is substantially fixed on the Bowman'"'"'s membrane of the eye with the epithelial cell layer.

91. The method of claim 90, wherein the gel-containing composition comprises a component selected from the group consisting of water soluble polymeric materials, water swellable polymeric materials and mixtures thereof.

92. The method of claim 90, wherein the gel-containing composition comprises at least one cellulosic component.

93. The method of claim 92, wherein the gel-containing composition comprises hydroxymethylcellulose.

94. A method for vision correction of an eye having a corneal epithelium and a Bowman'"'"'s membrane disposed under the corneal epithelium, the method comprising:

applying a liquid to a corneal epithelium of an eye, the liquid being effective in loosening the epithelium substantially without killing epithelial cells;

raising a portion of the loosened, moisturized epithelium to separate the portion of the corneal epithelium from the Bowman'"'"'s membrane to form an epithelial cell layer separated from the Bowman'"'"'s membrane and a pocket, the pocket extending between the epithelial cell layer and the Bowman'"'"'s membrane, the epithelial cell layer separated from the Bowman'"'"'s membrane having a periphery substantially attached to the Bowman'"'"'s membrane to fix a lens to the eye;

delivering, a gel-containing composition beneath the raised portion of the epithelium to maintain a spaced apart relationship between the epithelial cell layer and the Bowman'"'"'s membrane surface of the cornea;

forming one or more elongated incisions in the raised portion of the epithelium to access the pocket between the corneal epithelium and Bowman'"'"'s membrane; and

inserting a lens into the pocket through the one or more incisions such that the lens is substantially fixed on the Bowman'"'"'s membrane of the eye with the epithelial cell layer.

95. The method of claim 94, wherein the gel-containing composition comprises a component selected from the group consisting of water soluble polymeric materials, water swellable polymeric materials and mixtures thereof.

96. The method of claim 94, wherein the gel-containing composition comprises at least one cellulosic component.

97. The method of claim 96, wherein the gel-containing composition includes hydroxymethylcellulose.