Device for electrophysiological recording from the eye

Abstract

The present disclosure provides electroretinography devices configured to detect biopotential signals from an eye of a subject. In some embodiments, the device is configured to prevent the subject's eyelids from closing over the device when placed in contact with the anterior surface of the subject's eye. In some embodiments, the device has a Young's modulus of no more than about 50 MPa. In some embodiments, the device includes a diffusing or refracting element configured to scatter, focus or diverge incident light. In other embodiments, the device includes a void through which incident light can enter the subject's eye without passing through any portion of the device.

I/We claim: 
     
         1 . An ocular device configured to detect one or more biopotential signals from a patient, the ocular device comprising:
 an ocular region configured to be placed in contact with an anterior surface of an eye, wherein the ocular region is monolithic and comprises—
 a distal portion including an outermost sidewall and a distalmost edge defining a plane extending laterally across the ocular region; 
 a distal surface extending across at least a portion of the ocular region, wherein the distal surface is proximal to the plane defined by the distalmost edge; and 
 a proximal portion coupled to the distal portion and including a flange region extending from the sidewall of the distal portion in a radially outward direction, the flange region including an outer surface configured to abut an eyelid of the patient when the device is disposed over the eye; and 
   a conductor disposed within the ocular region and configured to be operatively connected to a signal relay.   
     
     
         2 . The ocular device of  claim 1 , wherein the distal surface is convex and extends between outer regions of the ocular region. 
     
     
         3 . The ocular device of  claim 1 , wherein the distal portion has a first maximum cross-sectional dimension and the proximal portion has a second maximum cross-sectional dimension greater than the first maximum cross-sectional dimension. 
     
     
         4 . The ocular device of  claim 1 , wherein, when the device is disposed over the eye, the distal portion is configured to inhibit the eyelid from blocking light received by the eye. 
     
     
         5 . The ocular device of  claim 1 , wherein the proximal portion comprises an inner surface having a first region with a first curvature, and a second region radially outward of the first region and having a second curvature different than the first curvature. 
     
     
         6 . The ocular device of  claim 1 , wherein the conductor is disposed within the ocular region such that a portion of the conductor is exposed, and wherein, when the device is disposed over the eye, the conductor is spaced apart from the anterior surface of the eye. 
     
     
         7 . The ocular device of  claim 1 , wherein the conductor consists of a conductive element forming an open or closed loop. 
     
     
         8 . The ocular device of  claim 1 , wherein the flange region extends from the sidewall of the distal portion such that a cross-sectional dimension of the flange region within the proximal portion decreases in a distal direction. 
     
     
         9 . An electroretinography device, comprising:
 an ocular region comprising—
 a first portion including an outermost sidewall and a distalmost surface defining a plane; 
 a second portion positioned radially inward of the sidewall and extending across the ocular region, the second portion including a generally convex distal surface that is proximal to the plane defined by the first portion; and 
 a third portion proximal to the first portion and the second portion, the third portion including a flange region extending from the sidewall of the first portion in a radially outward direction, the flange region including an inner surface and an outer surface each of which is curved such that, when the device is disposed over the eye, the outer surface abuts an eyelid of the eye and the inner surface abuts a sclera of the eye; and 
   a conductor disposed within the ocular region and configured to be operatively connected to a signal relay.   
     
     
         10 . The electroretinography device of  claim 9 , wherein, when the device is disposed over the eye, only a portion of the conductor, facing at least partially toward the eye, is exposed through the ocular region. 
     
     
         11 . The electroretinography device of  claim 9 , wherein the conductor is a single conductive element forming an open or closed loop. 
     
     
         12 . The electroretinography device of  claim 9 , wherein, when the device is disposed over the eye, the conductor is spaced apart from the anterior surface of the eye. 
     
     
         13 . The electroretinography device of  claim 9 , wherein the inner surface of the flange region includes a portion configured to conform to and contact a sclera of the eye when the device is disposed over the eye. 
     
     
         14 . The electroretinography device of  claim 9 , wherein the inner and outer surfaces of the flange region have a first thickness, and wherein the first portion has a second thickness greater than the first thickness. 
     
     
         15 . The electroretinography device of  claim 9 , wherein the flange region extends partially distally in a radially outward direction. 
     
     
         16 . The electroretinography device of  claim 9 , further comprising a stabilizing element disposed within the ocular region, wherein the single material of the ocular region is a first material having a first rigidity and the stabilizing element is formed of a second material having a second rigidity greater than the first rigidity. 
     
     
         17 . The electroretinography device of  claim 9 , wherein the ocular region is formed of a single material and comprises a continuous surface extending along an entirety of the ocular region. 
     
     
         18 . The electroretinography device of  claim 9 , wherein when the device is disposed over the eye, the ocular region covers an entire anterior surface of the eye and holds open the eyelid of the patient. 
     
     
         19 . The electroretinography device of  claim 18 , wherein the ocular region is formed of a single material and comprises a continuous surface extending along an entirety of the ocular region. 
     
     
         20 . The electroretinography device of  claim 9 , wherein the first portion has a first maximum cross-sectional dimension and the third portion has a second maximum cross-sectional dimension greater than the first maximum cross-sectional dimension. 
     
     
         21 . The electroretinography device of  claim 9 , wherein the inner surface comprises a first region having a first curvature and a second region, radially outward of the first region, having a second curvature different than the first curvature. 
     
     
         22 . The electroretinography device of  claim 21 , wherein the second curvature has a larger radius of curvature than that of the first curvature. 
     
     
         23 . An electroretinography device, comprising:
 a first portion including an outermost sidewall and a distalmost surface defining a plane;   a second portion positioned radially inward of the sidewall and extending across the ocular region, the second portion including a convex distal surface that is proximal to the plane defined by the first portion; and   a third portion proximal to the first portion and including a flange region extending from the sidewall of the first portion in a radially outward direction, the flange region including inner and outer surfaces each of which is curved such that, when the device is disposed over the eye, the outer surface abuts an eyelid of the eye and the inner surface covers an anterior surface of the eye,   wherein the first portion, the second portion, and the third portion are formed of a single material.