DEVICE FOR ELECTROPHYSIOLOGICAL RECORDING FROM THE EYE
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.
The present application is a divisional application of U.S. patent application Ser. No. 17/188,130 filed Mar. 1, 2023, which is a continuation of U.S. patent application Ser. No. 16/132,257 filed Sep. 14, 2018, which is a continuation of U.S. patent application Ser. No. 15/407,450 filed Jan. 17, 2017, which is a continuation of U.S. patent application Ser. No. 14/338,640 filed on Jul. 23, 2014, which claims priority to U.S. Provisional Patent Application Ser. No. 61/857,674, filed on Jul. 23, 2013, the disclosures of which are incorporated herein by reference in their entireties.
BACKGROUNDThe retina is the thin sheet of neural tissue that lines the inside of the eye, and which is responsible for converting the light that enters the eye into visual information that is then passed to the brain in the form of nerve impulses. Electroretinography (ERG) is the process of recording the bioelectric response of the retina in response to a visual stimulus, such as a brief flash of light. The response that is recorded when performing electroretinography is a voltage versus time waveform that can be analyzed to reveal a great deal of information about the physiology and health of the retina. ERG recording is therefore a commonly employed technique in vision science and ophthalmology. For instance, in ophthalmology, ERG recording can be used to diagnose a disease that affects the retina, such as glaucoma, or to monitor the effects of a treatment strategy aimed at a halting or reversing the damage caused by a retinal disease. ERG recording is non-invasive and is routinely performed in human subjects and animals such as mice, rats and cats.
ERG recording is accomplished by placing a recording electrode in gentle contact with the cornea, and then presenting a visual stimulus to the subject. The recording electrode can take one of several different forms.
Current reusable electroretinography devices can be expensive, scarce in the market, difficult to clean for reuse, uncomfortable for the subject, difficult to insert on the eye, and pose a risk of corneal abrasion due to the stiff materials used for construction. Current disposable electroretinography devices are typically highly unstable on the eye and produce inconsistent signals. Improved electroretinography devices are needed.
SUMMARYThe present disclosure provides electroretinography devices having the stability of a reusable device with the convenience of a disposable device formed primarily from a flexible, non-abrasive material to enhance subject comfort and safety. In some embodiments, the electroretinography device includes an electrode configured to contact the surface of a subject's eye. In some embodiments, a method of recording electroretinographic data includes contacting the surface of a subject's eye with an electrode housed in an electroretinography device disclosed herein.
In some embodiments, the present disclosure provides an electroretinography device comprising an ocular portion configured to detect a biopotential signal from an eye of a subject, the ocular portion including a proximal portion configured to be placed in contact with an anterior surface of the eye, a distal portion including at least one side wall, and a conductive element housed in the ocular portion; and a signal relay operatively connected to the conductive element and configured to transmit the biopotential signal from the conductive element to a signal processor.
Additional embodiments of the present technology may comprise the combination of one or more of the features described above, as well as variations of each feature that will be apparent to those of ordinary skill in the art based on the descriptions and figures included herein.
Many aspects of the present technology can be better understood with reference to the following drawings. The relative dimensions in the drawings may be to scale with respect to some embodiments. With respect to other embodiments, the drawings may not be to scale. For ease of reference, throughout this disclosure identical reference numbers may be used to identify identical or at least generally similar or analogous components or features.
These and other embodiments of the present technology are described in further detail below.
DETAILED DESCRIPTIONThe present disclosure generally provides electroretinography devices configured to detect a biopotential signal from an eye of a subject or a portion thereof (e.g., the retina) and transmit same to a processor. In some embodiments, the electroretinography device includes an ocular portion including a conductive element and a signal relay operatively connecting the conductive element and a signal processor.
A person of ordinary skill in the art will understand that embodiments of the present technology can have components and/or procedures in addition to those shown or described herein, and that these and other embodiments can be without several of the components and/or procedures shown or described herein without deviating from the present technology. The headings provided herein are for convenience only.
For ease of reference, throughout this disclosure identical reference numbers are used to identify similar or analogous components or features, but the use of the same reference number does not imply that the parts should be construed to be identical. Indeed, in many examples described herein, the identically-numbered parts are distinct in structure and/or function.
Generally, unless the context indicates otherwise, the terms “distal” and “proximal” within this disclosure reference a position or direction with respect to a subject's eye. “Distal” or “distally” therefore refer to a position distant from or in a direction away from the subject's eye, while the terms “proximal” and “proximally” refer to a position near or in a direction toward the subject's eye.
Unless the context clearly requires otherwise, throughout the description and the claims, the words ‘comprise’, ‘comprising’, and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.” Words using the singular or plural number also include the plural and singular number, respectively. Additionally, the words “herein,” “above,” and “below” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of the application.
The description of embodiments of the disclosure is not intended to be exhaustive or to limit the disclosure to the precise form disclosed. While the specific embodiments of, and examples for, the disclosure are described herein for illustrative purposes, various equivalent modifications are possible within the scope of the disclosure, as those skilled in the relevant art will recognize.
Specific elements of any foregoing embodiments can be combined or substituted for elements in other embodiments. Furthermore, while advantages associated with certain embodiments of the disclosure have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the disclosure.
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The proximal portion 28 may include one or two distinct contours to enable the ocular portion 20 to securely contact the anterior surface of the subject's eye. In some embodiments, the proximal portion 28 includes a single contour, for example that is complementary or substantially complementary to the curvature of at least a portion of the cornea. In other embodiments, such as that shown in
The ocular portion 20 may be formed of any suitable material that is biocompatible and transparent or translucent. In some embodiments, the material is flexible to reduce (e.g., minimize) the risk of mechanical abrasion to the anterior surface of the eye and/or the eyelids when the device is positioned on the subject's eye. In some embodiments, the material has a Young's modulus of elasticity of no more than about 50 mega-Pascals (50 MPa). In some embodiments, the materials comprise a component commonly used in the manufacture of soft contact lenses. In some embodiments, the material comprises, consists essentially of, or consists of polydimethylsiloxane (“PDMS”), which has a Young's modulus of elasticity of about 0.05 MPa to about 4.0 MPa.
The ocular portion 20 may be formed by any suitable fabrication techniques depending on the type of material(s) selected for the ocular portion 20. For example, the ocular portion 20 may be molded (e.g., injection molded) when the ocular portion 20 is formed predominantly of PDMS.
The conductive element 38 includes one or more wires configured to detect a biopotential signal from the subject's eye, for example from the retina. Any suitable electrically conductive material may be used to form the conductive element 38. For example and without limitation, the conductive element 38 may comprise, consist essentially of, or consist of stainless steel, gold, platinum, a conductive hydrogel, a conductive polymer, a conductive silicone, a doped silicon, a conductive saline, or combinations thereof. The conductive element 38 is housed at least partially in the ocular portion 20. For example, the conductive element 38 can be included at least partially within the distal portion 23, at least partially within the proximal portion 24, or at least partially in both, so long as the conductive element 38 is in electrical connectivity with the biopotential signals produced by the subject's eye.
The conductive element 38 can be configured to form any suitable shape, such as a curved shape or a polygon. In some embodiments, the conductive element 38 forms a shape such as a loop (e.g., a discontinuous loop such as that shown in
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In embodiments wherein the ocular portion 20 includes only one conductive element, a second conductive element separate from the electroretinography device 10 is typically attached to a portion of the subject's body to serve as a reference electrode. However, in other embodiments, the ocular portion 20 includes a first conductive electrode configured to detect biopotential signals from a subject's eye and a second conductive element configured to contact a different portion of the subject's eye. As shown in
In some embodiments, the ocular portion 20 may include a second conductive element positioned to contact a portion of the subject that is not a portion of the anterior surface of the eye, such as one or both eyelids. For example, as shown in
In some embodiments, the proximal portion 24 is configured to allow one or both eyelids to slide over the proximal portion 24. As shown in
In some embodiments, the ocular portion 20 is configured to permit incident light to reach the anterior surface of the eye unimpeded (e.g., without first passing through any portion of the ocular portion 20). In such embodiments, the ocular portion 20 may include a void 26a extending through the ocular portion 20. In some embodiments, such as that shown in
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The stabilizing element 40 may be positioned at any suitable location within the ocular portion 20, and may be configured in any suitable shape to provide rigidity to the ocular portion 20. In some embodiments, the stabilizing element 40 has a general ring shape and is positioned inside the distal portion 23 of the ocular portion 20, such as shown in
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In some embodiments, the ocular portion 20 further includes a diffusing component which has an index of refraction different than the index of refraction of the flexible material used to form the ocular portion 20. As shown in
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This disclosure is not intended to be exhaustive or to limit the present technology to the precise forms disclosed herein. Although specific embodiments are disclosed herein for illustrative purposes, various equivalent modifications are possible without deviating from the present technology, as those of ordinary skill in the relevant art will recognize. In some cases, well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Although steps of methods may be presented herein in a particular order, alternative embodiments may perform the steps in a different order. Similarly, certain aspects of the present technology disclosed in the context of particular embodiments can be combined or eliminated in other embodiments. While advantages associated with certain embodiments of the present technology may have been disclosed in the context of those embodiments, other embodiments can also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages or other advantages disclosed herein to fall within the scope of the present technology. Accordingly, this disclosure and associated technology can encompass other embodiments not expressly shown or described herein.
Claims
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.
Type: Application
Filed: Aug 17, 2023
Publication Date: Dec 7, 2023
Inventors: John R. Hetling (Dyer, IN), Safa Rahmani (Northbrook, IL), Tamas Ban (Grayslake, IL)
Application Number: 18/451,302