Corneal Onlay Devices and Methods

• US 20110208300A1
• Filed: 10/04/2010
• Published: 08/25/2011
• Est. Priority Date: 04/04/2008
• Status: Active Grant

• Current Assignee: Forsight Labs, LLC
• Original Assignee: Forsight Labs, LLC
• Inventors: Alejandro, Jose D., Sierra, David, Reich, Cary J., Boyd, Stephen, de Juan, Eugene JR.
• Granted Patent: US 9,125,735 B2
• Time in Patent Office: Days
• US Class Current: 623/5.14
• CPC Class Codes: A61F 2/142 Cornea, e.g. artificial corneae, keratoprostheses or corneal implants for repair of defective corneal tissue
• CPC Class Codes: A61F 2/1451 Inlays or onlays
• CPC Class Codes: A61F 2/1453 Corneal lenses connected to distinct attachment means
• CPC Class Codes: A61F 2250/0019 differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery

Abstract

A corneal only is configured to adhere to the cornea so as to inhibit epithelial growth under the onlay. Structures can be provided on the onlay to adhere the onlay to the eye. At least one of an epithelial layer or the water inhibiting layer can be provided on or over the onlay, for example a natural epithelial layer or water inhibiting layer that inhibits, for example minimizes, water penetration into the onlay, so as to adhere the onlay to the eye with pumping of the endothelium. The water inhibiting layer may comprise a therapeutic covering positioned over the onlay to inhibit swelling of the cornea. The posterior surface of the onlay may be shaped so as to fit the anterior exposed surface of the cornea.

Claims

1. A corneal onlay for placement on an exposed surface of a cornea of an eye to correct vision of the eye, the onlay comprising:

a lens comprising an optically transmissive material, wherein the lens is configured to adhere to the cornea.

8. The corneal onlay of claim 1 wherein the lens is configured to adhere to a Bowman'"'"'s membrane and/or a stroma with mechanical adhesion.

9. The corneal onlay system of claim 8 further comprising a glue for adhesion of the onlay to the stroma and/or to Bowman'"'"'s membrane.

2-7. -7. (canceled)

10-62. -62. (canceled)

63. A corneal onlay lens for placement on a cornea of an eye to correct vision of the eye, the onlay comprising:

a lens comprising a biocompatible material, the lens configured to adhere to the cornea with at least one of an epithelium or a water inhibiting material disposed over the lens.

64. The corneal onlay lens of claim 63 wherein the lens is configured to adhere to the cornea without an adhesive.

65. The corneal onlay lens of claim 63 wherein the at least one of the epithelium or the water inhibiting material comprises the water inhibiting material.

66. The corneal onlay lens of claim 65 wherein the water inhibiting material comprises a degradable material.

67. The corneal onlay lens of claim 66 wherein the degradable material is configured to degrade when epithelium is positioned over the onlay.

68. The corneal onlay lens of claim 66 wherein the degradable material is configured to degrade within about one week of placement on the cornea.

69. The corneal onlay lens of claim 67 wherein the degradable material comprises at least one of poly lactic acid (PLA), poly glycolic acid (PGA) or PLA/PGA copolymer.

71. The corneal onlay lens of claim 63 wherein the lens comprises an anterior water inhibiting layer, a posterior water permeable layer with a posterior surface shaped to fit an anteriorly exposed surface of the cornea, such that the lens is configured to adhere to the cornea in response to a pumping of water from the cornea with an endothelium of the cornea.

72. The corneal onlay of claim 71 wherein the anterior water resistant layer comprises an epithelial layer and the posterior water permeable layer comprises a stromal layer, and wherein the posterior surface and the anteriorly exposed surface of the cornea each comprise laser micromachined structures to connect the posterior surface with the anteriorly exposed surface.

216. The corneal onlay lens of claim 63 wherein the lens is configured to adhere to the cornea with an adhesive.

70. (canceled)

73-85. -85. (canceled)

86. An apparatus to form a lens on an exposed surface, the apparatus comprising:

at least one jet forming structure configured to form a jet; and

at least one cartridge coupled to the at least one jet forming structure, the at least one cartridge comprising at least one material component of the lens;

wherein the jet forming structure is configured to deliver the at least one material to the exposed surface to form the lens.

87. A deposition process to form a lens in a cornea of an eye, the cornea comprising an epithelium and a Bowman'"'"'s membrane and/or a stroma, the process comprising:

applying a material to the cornea to penetrate the epithelium and deposit the material in or on the Bowman'"'"'s membrane and/or the stroma and wherein the material is deposited over time to form the lens in or on the Bowman'"'"'s membrane and/or the stroma.

88-90. -90. (canceled)

91. A method of adhering an onlay on a cornea, the method comprising:

adhering the onlay to a surface of the cornea with Van der Waals forces.

92. A corneal onlay for placement on an exposed Bowman'"'"'s membrane and or cornea, the onlay comprising:

a lens comprising an anterior surface and a posterior surface, wherein the posterior surface comprises nano-structures to adhere the onlay to the cornea via Van der Waals forces.

93. A method of adhering an onlay on a cornea, the method comprising:

sealing the anterior surface of the cornea with a covering positioned over the onlay to adhere the onlay to the cornea with endothelial pumping of water from the cornea.

94. A method of adhering an onlay on a cornea, the method comprising:

sealing the anterior surface of the cornea with the onlay to adhere the onlay to the cornea with suction.

95. The method of claim 94 wherein the suction comprises water suction.

96. A method of adhering an onlay on a cornea, the cornea comprising a stroma and/or a Bowman'"'"'s membrane, the method comprising:

cutting and/or excising a peripheral portion of the stroma and/or Bowman'"'"'s membrane; and

inserting a peripheral portion of the onlay into the peripheral portion.

97-103. -103. (canceled)

104. A method of treating a keratoconus of a cornea of an eye, the cornea comprising an epithelium and a Bowman'"'"'s membrane and/or a stroma, the method comprising:

removing at least a central portion of the epithelium to expose an anterior surface of the Bowman'"'"'s membrane and/or the stroma; and

adhering a corneal onlay to the exposed anterior surface of the Bowman'"'"'s membrane and/or the stroma.

105. An onlay to treat a cornea of the eye, the cornea comprising an epithelium and a Bowman'"'"'s membrane and/or a stroma, onlay comprising:

a first portion configured to correct an optical defect of the eye;

a second portion configured to adhere a to a conjunctiva of the eye; and

a third portion extending from the second potion to third portion to anchor the onlay to the conjunctiva.

106. A system to correct vision of an eye having a cornea, the cornea comprising a stroma and/or Bowman'"'"'s membrane under an epithelium, the system comprising:

an onlay configured to correct vision when positioned on the stroma and/or Bowman'"'"'s membrane; and

a covering, the covering comprising a layer of a water impermeable material positionable over the onlay on the stroma and/or Bowman'"'"'s membrane of the eye.

107. The system of claim 106 wherein the covering is configured to inhibit swelling of the cornea.

108. The system of claim 107 wherein the layer is configured to inhibit swelling of the cornea for a plurality of days when positioned on the eye over the onlay.

109. The system of claim 108 wherein the layer is configured to minimize swelling of the cornea for the plurality of days.

113. The system of claim 106 wherein the layer is configured to adhere to the epithelium for a plurality of days.

114. The system of claim 113 wherein the therapeutic covering is configured to separate from the epithelium such that the epithelium remains on the onlay and the Bowman'"'"'s and/or stroma.

110-112. -112. (canceled)

115-117. -117. (canceled)

118. A system to correct vision of an eye having a cornea, the cornea comprising a stroma and/or Bowman'"'"'s membrane, the system comprising:

an onlay configured to correct vision when positioned on the stroma and/or Bowman'"'"'s membrane; and

a covering, the covering comprising at least one layer of a therapeutic material, the covering positionable over onlay to inhibit water flow to the stroma and/or Bowman'"'"'s membrane.

120. The system of claim 118 wherein the at least one layer is configured to decrease swelling of the cornea to within about 5% of a thickness of a pre-operative value of the cornea.

127. The system of claim 118 further comprising an anterior refracting surface disposed on the at least one layer to correct vision of the eye.

119. (canceled)

121-123. -123. (canceled)

129-132. -132. (canceled)

133. A system to correct vision of an eye of a patient, the eye comprising a cornea, the system comprising:

an onlay configured for placement on a Bowman'"'"'s membrane of the eye; and

a covering comprising a first portion comprising a lens configured for positioning on the eye;

at least a second portion configured to conform to irregularities of the epithelium to adhere to the first portion and the onlay to the cornea to inhibit motion.

134. The system of claim 133 wherein the at least the second portion is configured with a lower hydrophobic surface to adhere the first lens portion and the onlay to the cornea with mechanical resistance sufficient to resist a blink of the eyelid.

135. A system to correct vision of an eye having a cornea having an epithelium, the system comprising:

an onlay to correct the vision of the patient; and

a covering comprising at least one region adapted to conform to the shape of cornea to decrease swelling of the cornea and adhere the onlay to the cornea.

136. The system of claim 135, wherein the covering is configured to at least one of deturgesce or minimize swelling of the cornea when the covering is placed on the cornea over the onlay.

137. The system of claim 135, wherein the covering comprises a thickness of no more than about 200 microns and a width of at least about 5 mm to conform to the cornea and the onlay.

138. The system of claim 135, wherein the covering comprises at least one of a hydrophobic layer or an upper hydrophobic surface extending along at least an inner portion of the covering to inhibit water flow through the covering.

143. The system of claim 135, wherein the covering comprises a thickness within a range from about 25 to about 100 microns and an oxygen Dk parameter of at least about 80.

144. The system of claim 143, wherein the Dk comprises an oxygen permeability parameter and wherein the Dk comprise at least about 350 or more to inhibit swelling when the covering is worn for a plurality of days.

145. The system of claim 135, wherein the covering comprises an upper optical surface extending along at least an inner portion of the covering.

149. The system of claim 135, wherein the covering comprises a lower curved surface extending along at least an outer portion of the covering, the lower curved surface shaped to fit the cornea away from the onlay.

150. The system of claim 149, wherein the outer portion is adapted to form a seal with an epithelium of the cornea away from the onlay.

151. The system of claim 150 wherein the outer portion comprises a covering with a radius of curvature and is configured to stretch when the peripheral portion of the covering is placed against a peripheral portion of cornea away from the onlay and wherein the covering radius of curvature is less than a radius of curvature of the cornea.

155. The system of claim 135, further comprising a contact lens configured to hold the covering against an epithelial defect when the epithelial defect heals, wherein the covering is adapted to conform to a curved surface contour of the cornea when the contact lens retains the covering against the epithelial defect.

139-142. -142. (canceled)

146-148. -148. (canceled)

152-153. -153. (canceled)

156. A method of correcting vision of a patient having an eye and a cornea, the method comprising:

providing an onlay on the cornea to correct vision; and

placing a covering on the cornea over the onlay, wherein the covering is adhered to the cornea to reduce swelling of the cornea.

157. The method of claim 156 wherein the epithelium is separated from a Bowman'"'"'s membrane to position the onlay on the Bowman'"'"'s membrane and wherein the epithelium regenerates between the onlay and the covering.

158. The method of claim 157 wherein the onlay is positioned in an epithelial pocket with epithelium disposed between the onlay and the covering.

159. The method of claim 157 wherein the epithelium is debrided to expose the Bowman'"'"'s membrane and the onlay positioned on the Bowman'"'"'s membrane.

160. The method of claim 157 wherein the onlay is molded in situ on the cornea.

161. The method of claim 156 wherein the covering forms a seal with the cornea to decrease water flow into the cornea.

162. The method of claim 156 wherein the covering comprises an outer periphery and wherein the epithelium grows over at least a portion of the outer periphery.

163. The method of claim 162 wherein the covering is placed on the epithelium such that the epithelium is disposed under the outer periphery when the epithelium grows over the outer periphery.

164. The method of claim 156 wherein the covering is placed over an epithelial defect of the cornea and wherein the covering is removed when the epithelial defect is healed.

165. The method of claim 164 wherein the epithelium remains on the cornea and the onlay and separates from the covering when the covering is removed.

166. The method of claim 165 further comprising providing water to the eye to loosen the covering from the epithelium when the covering is removed.

167. The method of claim 156 wherein the covering comprises a substantially water impermeable material to inhibit swelling of the cornea when the seal is formed.

168. The method of claim 156 wherein the covering comprises a substantially oxygen permeable material.

169. The method of claim 156 wherein the cornea comprises an epithelial defect when the covering is placed on the cornea, the method further comprising removing the covering when the epithelial defect is healed.

170. The method of claim 156 further comprising:

measuring the cornea to determine a characteristic of the covering; and

selecting the covering from among a plurality of coverings in response to the characteristic such that the seal is formed when the covering is placed on the cornea.

171-173. -173. (canceled)

174. A system to correct vision of an eye of a patient, the eye having a cornea, the system comprising:

an onlay configured for placement on the cornea to correct the vision of the patient; and

a covering comprising,

an inner portion comprising a lens; and

an outer portion configured to conform to irregularities of the cornea of the eye to retain the inner portion comprising the lens over the onlay.

175-205. -205. (canceled)

206. A method of treating vision of an eye having a cornea, the method comprising:

providing an onlay on the cornea; and

placing a covering on the cornea of the eye over the onlay, wherein swelling of the cornea decreases when the covering is positioned over the onlay and adhered to the cornea.

207. The method of claim 206 wherein the covering is adhered to the cornea with water suction.

208. The method of claim 207 wherein the endothelium pumps water from the cornea to suck the covering onto the cornea.

209. The method of claim 206 wherein a contact lens is placed over the covering to adhere the covering to the cornea.

210. The method of claim 209 wherein the contact lens is removed from the covering when the covering is adhered to the cornea with the onlay positioned under the covering.

211-215. -215. (canceled)