METHOD OF TESTING TEARS AS A BIOMARKER FOR CANNABINOIDS

Abstract

A method of obtaining and processing a tear sample from an individual, includingobtaining a sample of tears from an individual by use of a flexible tapered polymer structure having opening at a distal end thereof, the opening having a diameter of less than 1 millimeter and placing the distal end of the flexible tapered polymer structure into contact with the tears adjacent the eye and applying negative pressure to the flexible tapered polymer structure. The method further includes buffering the sample of tears by addition of a buffering solution, analyzing the sample of tears to identify cannabinoids within the sample of tears; and presenting results of analysis of the sample of tears.

Claims

1. A method of obtaining and processing a tear sample from an individual, comprising; obtaining a sample of tears from an individual by use of a flexible tapered polymer structure having opening at a distal end thereof, the opening having a diameter of less than 1 millimeter; placing the distal end of the flexible tapered polymer structure into contact with the tears adjacent the eye and applying negative pressure to the flexible tapered polymer structure; buffering the sample of tears by addition of a buffering solution; analyzing the sample of tears to identify cannabinoids within the sample of tears; and presenting results of analysis of the sample of tears.

2. The method as claimed in claim 1, further comprising obtaining the sample of tears by application of a micropipette as the flexible tapered polymer structure.

3. The method as claimed in claim 1, further comprising obtaining the sample of tears by application of a capillary tube as the flexible tapered polymer structure.

4. The method as claimed in claim 1, further comprising obtaining the sample of tears by further application of an absorbent material.

5. The method as claimed in claim 1, further comprising analyzing the sample to identify the cannabinoids by application of color testing.

6. The method as claimed in claim 1, further comprising analyzing the sample to identify the cannabinoids by application of gas chromatography.

7. The method as claimed in claim 1, further comprising analyzing the sample to identify the cannabinoids by application of high performance or high pressure liquid chromatography.

8. The method as claimed in claim 1, further comprising analyzing the sample to identify the cannabinoids by application of gas chromatography-flame ionization detection (GC-FID).

9. The method as claimed in claim 1, further comprising analyzing the sample to identify the cannabinoids by application of gas chromatography-mass spectrometry (GC-MS).

10. The method as claimed in claim 1, further comprising analyzing the sample to identify the cannabinoids by application of thin layer chromatography (TLC).

11. The method as claimed in claim 1, further comprising analyzing the sample to identify the cannabinoids by application of spectrometry.

12. The method as claimed in claim 1, further comprising analyzing the sample to identify the cannabinoids by application of the mass spectrometry.

13. Method as claimed in claim 1, further comprising separating a lipid fraction of the tear sample from aqueous components, mucin component or both of the tear sample for testing.

14. A device that facilitates detecting cannabinoids in tears, comprising: a sampling structure including a flexible tapered polymer structure having opening at a distal end thereof, the opening having a diameter of less than 1 millimeter; a sampling device applying negative pressure to the flexible tapered polymer structure; a container adapted to store a buffering solution formulated to buffer the sample of tears for testing; analyzing the sample of tears to identify cannabinoids within the sample of tears; and presenting results of analysis of the sample of tears.

15. The device of claim 14, wherein the sampling structure is internal to the device.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Subject matter hereof may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying figures, in which:

[0048] FIG. 1 is a schematic depiction of the eye and tear film including the tear film layers;

[0049] FIG. 2 is a block diagram of a tear film sampling and testing device according to an example embodiment of the invention;

[0050] FIG. 3 is a flow chart depicting a sampling and testing method according to an example embodiment of the invention;

[0051] FIG. 4 is a flow chart depicting a sampling and testing method according to an example embodiment of the invention; and

[0052] FIG. 5 is a depiction of a sampling device according to an example embodiment of the invention.

[0053] While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the claimed inventions to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.

DETAILED DESCRIPTION

[0054] Referring to FIG. 1, the tear film is schematically depicted within an eye 100. The tear film generally is considered to include 3 layers. Starting from the surface of the cornea 102 these layers include the mucin layer 104, the aqueous layer 106, and a lipid layer 108. Because of gravity, some of the tear film tends to accumulate at the junction where the cornea meets the lower eyelid in what is commonly referred to as the tear meniscus 20.

[0055] Referring to FIG. 2, a block diagram of tear film cannabis testing device 10 is depicted. Testing device 10 generally includes sampling structure 12 and testing structure 14. Testing structure 14 may include internal testing structure 16, external testing structure 18, or both. Sampling structure 12 is utilized to obtain a sample from, for example, tear film meniscus 20. Testing device 10 may also include a storage structure 22 configured to store at least one of the sampling structure 12 and the testing structure 14. For example, storage structure 22 may be configured to store external testing structure 18.

[0056] Referring to FIG. 3, a flowchart of a method according to an example embodiment of the invention is depicted. According to the exemplary embodiment, a sample of the tear film meniscus 20 is obtained (step 24) via the sampling structure 12 and analyzed (step 26) via the testing structure 14. In some embodiments, the sample is analyzed using internal testing structure 14. In other embodiments, the sample is analyzed using external testing structure 16. Embodiments of the method may also include presenting results of the analysis at step 28.

[0057] According to example embodiments of the invention, tear samples may be obtained by use of a micropipette, capillary tube or absorbent material such as absorbent filter paper. Absorbent filter paper may take the form of a strip of material to be placed into the lower cul-de-sac much in a similar fashion to the use of a Schirmer's strip. Absorbent material sampling may also include the use of filter paper discs, cellulose sponges and polyester rods as well as other fabric-based materials. Absorbent materials utilized should be packaged in a sterile fashion for single use and applied to the tear film to gather a consistently measured quantity of the tear film. Similarly, a micropipette or capillary tube should be packaged in a sterile fashion for single use.

[0058] According to an example embodiment of the invention, the presence of cannabinoids in the tear film can be analyzed by application of color testing, gas chromatography, high-performance liquid chromatography or high-pressure liquid chromatography, gas chromatography-flame ionization detection (“GC-FID”), thin layer chromatography (“TLC”), spectrometry, or mass spectrometry.

[0059] Referring to FIG. 4, according to another example embodiment of the invention, a method of obtaining and processing a tear sample from an individual, includes obtaining a sample of tears from an individual by use of a flexible tapered polymer structure having opening at a distal end thereof. S30 For example, the opening has a diameter of less than 2 millimeters or less than 1 millimeter, in another example the opening is less than 0.5 mm, in a further example less than 0.2 mm. The method includes placing the distal end of the flexible tapered polymer structure into contact with the tears adjacent the eye and applying negative pressure to the flexible tapered polymer structure. S32 The method further includes buffering the sample of tears by addition of a buffering solution S34 followed by analyzing the sample of tears to identify cannabinoids within the sample of tears S36 and presenting results of analysis of the sample of tears S38.

[0060] The method may further include obtaining the sample of tears by application of a micropipette as the flexible tapered polymer structure. S40

[0061] The method may also include obtaining the sample of tears by application of a capillary tube as the flexible tapered polymer structure. S42

[0062] The method may further include obtaining the sample of tears by further application of an absorbent material. S44

[0063] In another embodiment, the method may further include analyzing the sample to identify the cannabinoids by application of color testing. S46

[0064] In other example embodiments the method may include analyzing the sample to identify the cannabinoids by application of gas chromatography S48; by application of high performance or high pressure liquid chromatography S50; by application of gas chromatography-flame ionization detection (GC-FID) S52; by application of gas chromatography-mass spectrometry (GC-MS) S54; or by application of thin layer chromatography (TLC) S56.

[0065] Example methods may include analyzing the sample to identify the cannabinoids by application of spectrometry S58; or by application of the mass spectrometry S60.

[0066] The method may include separating a lipid fraction of the tear sample from aqueous components, mucin component or both of the tear sample for testing. S62.

[0067] According to another example embodiment, a device that facilitates detecting cannabinoids in tears, including: a sampling structure including a flexible tapered polymer structure having opening at a distal end thereof, the opening having a diameter of less than 1 millimeter; a sampling device applying negative pressure to the flexible tapered polymer structure and a container adapted to store a buffering solution formulated to buffer the sample of tears for testing.

[0068] The sampling structure may be internal to the device. The device may include the storage structure being configured to receive the sampling structure and the testing structure. The sampling structure may be external.

[0069] A further example embodiment may include a method of detecting cannabinoids including obtaining a sample of tears from an individual; and analyzing the sample of tears to identify cannabinoids within the sample of tears.

[0070] In yet a further example embodiment of the invention the method of identifying cannabinoids in tear film may further comprise separating a lipid fraction of the tear sample from an aqueous component, a mucin component or both the aqueous and mucin component of the tear sample prior to analysis for the presence of cannabinoids. In this exemplary embodiment, the storage structure 22 may be configured to store the materials required to perform the separation and store the resultant components.

[0071] Referring to FIG. 5, a further example embodiment of the invention includes a device 64 that facilitates detecting cannabinoids in tears, including a sampling structure 66 including a flexible tapered polymer structure 68 having opening 70 at a distal end thereof, opening 70 having a diameter of less than 1 millimeter; a sampling device 72 structured to apply negative pressure to the flexible tapered polymer structure 68; a container adapted to store a buffering solution formulated to buffer the sample of tears for testing; and a structure that is adapted for analyzing the sample of tears to identify cannabinoids within the sample of tears; and to present results of analysis of the sample of tears.

[0072] For example, the sampling structure may be internal to the device.

[0073] According to an example, a storage structure may be configured to receive the sampling structure and the testing structure.

[0074] Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions.

[0075] Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.

[0076] Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended.

[0077] Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.

[0078] For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. § 112(f) are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.