Patent Application
20210307732
All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
This application claims the benefit of the filing date of U.S. Provisional Application 62/718,851, filed Aug. 14, 2018, the contents of which are incorporated herein by reference in their entirety for all purposes.
Roadside driver tests to detect marijuana and other drugs are increasing in importance because drug availability and usage is increasing. Further, it is currently very difficult to enforce Driving Under the Influence of Drug (DUID) laws with existing oral fluid (i.e., saliva), breath, and blood tests. The lack of adequate roadside drug testing and effective DUID enforcement can result in a larger number of serious and/or fatal accidents.
According to an April 2017 poll, approximately 22% of American adults, or −54.5 million people, currently use marijuana, with 63% of this group indicating regular use. There are thus nearly as many marijuana users as there are cigarette smokers (˜59 million cigarette smokers). This number is expected to increase as marijuana legalization becomes more common. Additionally, the Department of Justice reports that the overall availability of controlled prescription and illegal drugs in the U.S. is also increasing or remaining stable at high rates. In a 2017 National Drug Threat report, the DEA noted that more individuals report current use of controlled prescription drugs than for cocaine, heroin, and methamphetamine combined, making controlled prescription drug use second only to marijuana.
As a result of increased drug usage, there are more drug-impaired drivers on the road than ever before. Indeed, drivers in fatal crashes are now more likely to be under the influence of drugs than alcohol. In Colorado, one of the first states to legalize recreational marijuana (2012), a November 2017 survey conducted by the Colorado Department of Transportation found that 55% of marijuana users believed it is safe to drive while under the influence. However, studies show that under the influence of THC, the psychoactive compound in marijuana, a user's reaction time and perception of distance and speed are both impaired.
There is currently not an efficient and reliable quantitative roadside test for marijuana and other drug use.
Accordingly, an efficient and reliable quantitative roadside test for marijuana and other drugs is desired.
In general, in one embodiment, a system for drug testing includes a collector configured to collect saliva, a processor configured to mate with the collector, and a detector. The processor is configured to automatically extract a first sample of the saliva and a second sample of the saliva. The detector is configured to mate with the processor and to analyze the first sample to detect an amount of drug in the collected saliva.
This and other embodiments can include one or more of the following features. The collector can be disposable. The processor can be disposable. The processor can be configured to fit within the detector. The system can be portable. The system can be less than 3,000 cubic inches. The system can weigh less than 10 kg. The processor can include automatic cleaning features therein for cleaning between uses. The processor can include a sample concentrator therein configured to automatically concentrate and prepare the first sample.
In general, in one embodiment, a device for collecting a saliva sample includes a hollow elongate body, a hollow bulb at a proximal end of the hollow elongate body, and a vent in fluid communication with the elongate body. The hollow bulb is configured to be chewed by the user. A proximal end of the hollow bulb has an opening therein to allow saliva to be transferred therethrough and into the hollow elongate body. The vent is configured to allow air to pass therethrough from the hollow elongate body.
In general, in one embodiment, a method of drug testing includes: (1) obtaining a saliva sample from a collector having a chewable bulb, (2) automatically generating a concentrated sample with a processor, and (3) inserting the concentrated sample into a portable detector to detect whether drug is present in the sample.
In one aspect, provided herein is a device for collecting a liquid sample, such as saliva, comprising: (a) a mouthpiece comprising an opening communicating with an internal space, the mouthpiece comprising a pliable material, and configured to receive the liquid, e.g., saliva, through the opening and into the space; (b) an elongate body comprising a lumen communicating with the space and configured to receive the liquid, e.g., saliva, from the internal space; (c) a vent, separate from the mouthpiece, comprising one or a plurality of apertures in fluid communication with the lumen and configured to allow air to pass therethrough and out of the device; and (d) a collection portion comprising a collection space configured to collect the liquid, e.g., saliva received into the lumen; wherein the device has dimensions configured to allow a user to chew the mouthpiece when the device inserted into the user's mouth. In one embodiment the device has a length between about 5 cm and about 20 cm, e.g., about 8 cm and about 15 cm. in another embodiment the mouthpiece has a bulb shape that is wider than the elongate body at a point of communication. In another embodiment the mouthpiece comprises a material selected from rubber and a plastic (e.g., low-density polyethylene, PVC, ABS, polystyrene, rubber, silicone, peek and tygon). In another embodiment the opening in the internal space has a volume of about 0.5 ml to about 5 ml, e.g., about 2 ml. In another embodiment the opening in the mouthpiece has a widest diameter of about 2 mm to about 10 mm, e.g., about 4 mm to about 8 mm. In another embodiment the mouthpiece comprises a composition that promotes salivation. In another embodiment the composition has a sour or sweet taste. In another embodiment the composition comprises citric acid, acetic acid malic acid, fumaric acid, and tartaric acid, sucrose, sodium chloride or an artificial sweetener (e.g., Splenda, saccharin, aspartame)). In another embodiment the lumen comprises surface features that promote breaking of bubbles in saliva. In another embodiment the vent comprises a plurality of apertures. In another embodiment the elongate body comprises a proximal portion positioned proximal to the mouthpiece and a distal portion positioned proximal to the collection portion, wherein the proximal portion is positioned radially within the distal portion wherein a plurality of the apertures are positioned radially with respect to an axis of the lumen. In another embodiment the proximal portion and the distal portion are configured as barrels wherein the proximal barrel is fitted radially into the distal barrel and defines an annular space between the two barrels, through which air can vent from the device. In another embodiment the elongate body comprises an elongate portion communicating through the one or more apertures with a vent tube oriented off-axis to the elongate member, wherein the vent tube comprises an aperture venting to air. In another embodiment the vent tube comprises a valve to inhibit escape of liquid from the vent tube. In another embodiment the one or a plurality of apertures are positioned between the mouthpiece and the collection space. In another embodiment the device is comprised in a single piece. In another embodiment the elongate body and the mouthpiece are comprised in separate pieces, fitted together. In another embodiment the elongate body and the mouthpiece are comprised in a single piece. In another embodiment the elongate body and the collection portion are comprised in separate pieces, fitted together. In another embodiment the elongate body and the collection portion are comprised in a single piece. In another embodiment the collection portion comprises a breakable seal which, when broken, allows collection of liquid from the collection portion. In another embodiment the seal is a friable seal. In another embodiment the seal comprises a foil. In another embodiment the device further comprises a mating element configured to mate the device with an interface of a processor and transmit liquid thereto. In another embodiment the mating element comprises a nipple, a tee, a valve, a screw lock or threaded tip (e.g., a luer lock) or a friction fit. In another embodiment the device further comprises a pump configured to promote air flow from the vent. In another embodiment the pump comprises a diaphragm pump. In another embodiment the pump exerts suction on the lumen.
In another aspect, provided herein is a method comprising: (a) providing a device comprising: (i) a mouthpiece comprising an opening communicating with an internal space, the mouthpiece comprising a pliable material, and configured to receive the liquid, e.g., saliva, through the opening and into the space; (ii) an elongate body comprising a lumen communicating with the space and configured to receive the liquid, e.g., saliva, from the internal space; (iii) a vent, separate from the mouthpiece, comprising one or a plurality of apertures in fluid communication with the lumen and configured to allow air to pass therethrough and out of the device; and (iv) a collection portion comprising a collection space configured to collect the liquid, e.g., saliva received into the lumen; wherein the device has dimensions configured to allow a user to chew the mouthpiece when the device inserted into the user's mouth; b) chewing on the mouthpiece of a device stimulate saliva production; c) collecting the saliva in collection space of the collection portion. In one embodiment the method further comprises using a pump to pump air out of the device. In another embodiment the method further comprises: d) detecting the presence of a drug in the collected liquid, e.g., saliva. In another embodiment the drug comprises a cannabinoid (e.g., delta-9-tetrahydrocannabinol (“THC”), cannabidiol (“CBD”), cannabinol (“CBN”), or tetrahydrocannabivarin (“THCV”). In another embodiment detecting is performed at the site of collecting (e.g., without sending the sample to laboratory remote from the point of collection. In another embodiment detecting is performed within 30 minutes of the time of collecting. In another embodiment collecting is performed by a law enforcement official. In another embodiment, collection is performed at a roadside. In another embodiment, collection can be performed at a location remote from detection, for example, in another building, in another city, at least 1 mile from the point of collection, at least 5 miles from the point of collection or at least 25 miles from the point collection.
In another aspect provided herein is a system for drug testing, comprising: a collector configured to collect saliva; a processor configured to mate with the collector, the processor configured to automatically extract a first sample of the saliva and a second sample of the saliva; and a detector configured to mate with the processor, the detector configured to analyze the first sample to detect an amount of drug in the collected saliva. In one embodiment the collector is disposable. In another embodiment the processor is disposable. In another embodiment the processor is configured to fit within the detector. In another embodiment the system is portable. In another embodiment the system is less than 3,000 cubic inches. In another embodiment the system weighs less than 10 kg. In another embodiment the processor includes automatic cleaning features therein for cleaning between uses. In another embodiment the processor includes a sample concentrator therein configured to automatically concentrate and prepare the first sample.
In another aspect provided herein is a device for collecting a saliva sample, comprising: a hollow elongate body; hollow bulb at a proximal end of the hollow elongate body configured to be chewed by the user, a proximal end of the hollow bulb having an opening therein to allow saliva to be transferred therethrough and into the hollow elongate body; and a vent in fluid communication with the hollow elongate body and configured to allow air to pass therethrough from the hollow elongate body.
In another aspect provided herein is a method of drug testing comprising: obtaining a saliva sample from a collector having a chewable bulb; automatically generating a concentrated sample with a processor; and inserting the concentrated sample into a portable detector to detect whether drug is present in the sample.
The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:
Described herein are portable drug testing apparatuses, systems, and methods that can be efficiently and reliably used to both collect evidentiary oral fluid samples and collect and analyze oral fluid samples to provide quantitative results quickly for driver impairing substances. The apparatuses, systems, and methods described herein can be performed on-site (e.g., on the roadside), can be fully automated, and can provide quantitative results for a large number of substances.
Referring to
An exemplary system 300 for testing for impairing substances is shown in
A saliva collection device of this disclosure includes: (a) a mouthpiece comprising an opening communicating with an internal space, the mouthpiece comprising a pliable material, and configured to receive saliva through the opening and into the space; (b) an elongate body comprising a lumen communicating with the space and configured to receive saliva from the internal space; (c) a vent, separate from the mouthpiece, comprising one or a plurality of apertures in fluid communication with the lumen and configured to allow air to pass therethrough and out of the device; and (d) a collection portion comprising a collection space configured to collect fluid received into the lumen; wherein the device has dimensions configured to allow a user to chew the mouthpiece when the device inserted into the user's mouth.
A close-up of an exemplary collector device 431 is shown in
Further, the device 431 can comprise a collection portion at an end of the elongate member distal from the mouthpiece and comprising a collection space 460 to collect liquid received from the mouthpiece into the lumen.
The elongate member can terminate distal to the mouthpiece in a mating element 437 configured to mate with an interface of a processor. The mating element 437 can comprise, for example, a nipple, a tee, a valve, a screw lock or a threaded tip (e.g., a luer lock), or a friction fit. The mating element 437 typically includes an opening that is typically sealed with a removable or breakable seal 447. So, for example, the mating element 437 can comprise a threaded tip. The sealed opening 447 (e.g., a plastic or foil seal) can retain the oral fluid sample until the collector device 431 is mated with the processor. Upon mating, the seal can break. This can be a college, for example, by providing a piercing or tearing element such as a pin or a sharp protrusion. In some embodiments, the elongate member 445 can include markers thereon to indicate the volume of collected fluid. In some embodiments the elongate member can have antioxidants to help preserve the sample. In some embodiments the elongate member can be coated with pH buffering material. The buffer can be dry or liquid. The pH buffer aids in stabilizing and preparing the oral fluid for analysis. In some embodiments the elongate member 445 can be curved to allow for collection of oral fluid near the bottom of the mouth. In some embodiments, the elongate member 445 can include a sensor to indicate the volume of collected fluid.
In use, the user (e.g., the driver or test subject) can place the mouthpiece 441 into the mouth with the elongate member 445 positioned substantially vertically (e.g., with the distal end 437 pointed downwards). The user can then chew on the mouthpiece 441 to activate the salivary glands. Accordingly, the device 431 can have dimensions such that when inserted into the mouth, the mouthpiece can be chewed, for example, by the molars of an adult human user. The saliva can drop downwards through the opening 443 into space 442 of the mouthpiece 441 and onwards into the lumen 446 of hollow elongate member 445. Advantageously, the salivary glands can be activated by chewing on the mouthpiece 441 even if the user is experiencing dry mouth, e.g., caused by tetrahydrocannabinol (THC). The user can continue to chew on the mouthpiece 441 until the desired amount of saliva has been collected in the hollow elongate member 445. In some embodiments, the mouthpiece 441 can comprise, e.g., be coated (externally or internally) with a chemical composition to enhance oral fluid production (e.g., citric acid, acetic acid malic acid, fumaric acid, and tartaric acid, sucrose, sodium chloride, and artificial sweetener (e.g., Splenda, saccharin, aspartame)).
Samples collected by the device may be frothy, that is, may contain bubbles. These bubbles may interfere with collection of liquid in the sample. Accordingly, device 431 can comprise a venting mechanism such that gas released from bubbles is vented from the device into the environment, e.g., the air. The venting mechanism can comprise one or a plurality of apertures in the device to allow passage of gas from the lumen of the elongate body into the environment.
Collection devices of this disclosure comprise a vent to allow air to escape from spaces internal to the device. The vent includes one or more apertures in the elongate member that communicate with the environment, e.g., with air.
One embodiment of a vent is shown in
In some embodiments the collection portion 493 is split into two collectors. This allows one sample to be archived for later analysis.
In another embodiment, as shown in
The vent can have a pump attached. The pump removes the air and assists in collecting the oral fluid. The pump can be battery operated or manual operated. The pump can be disposable or reusable. The pump can comprise a diaphragm pump, a syringe pump or other pump.
Referring to
As shown in
THC and other drugs are known to degrade over time due to oxygen. For samples that require prolonged storage a radical/oxygen reagent can be added, such as Butylated hydroxytoluene or other known preservatives. In addition, a secondary compound which has a decay that correlates with THC can be added in order to determine the amount of THC at time of collection. This includes but is not limited to synthetic cannabinoids (not found in nature).
The processor 533 can be used to extract the chemical(s) for which testing is being performed from the saliva sample. For example, the processor 533 can be configured to extract THC from the sample. Such extraction can be useful because tetrahydrocannabinolic acid (THCA), the carboxylic acid form of THC, is present in marijuana in high concentrations, sometimes exceeding the THC concentration. THCA is not psychoactive, and the presence in oral fluid is not an indicator of intoxication. However, THCA can cause false positives in analysis.
Additionally, in some embodiments, the processor 533 can be configured to separate the extracted sample into separate samples—one for analysis and one for storage (e.g., for evidentiary purposes and/or further analysis). The second sample (e.g., for evidentiary purposes) can be configured to be stored within the processor 533 until it is needed. The two samples can each be, for example, between 1μ-10 ml in size.
Referring back to
In some embodiments, as shown in
As shown in
The overall method of gathering the oral fluid through analysis is shown in
It should be understood that any feature described herein with respect to one embodiment can be substituted for, or used in addition to, any feature described herein with respect to another embodiment.
When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.
Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present disclosure.
Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps. The term “consisting essentially of” refers to the inclusion of recited elements and other elements that do not materially affect the basic and novel characteristics of a claimed combination.
As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical range recited herein is intended to include all sub-ranges subsumed therein.
Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US19/46217 | 8/12/2019 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62718851 | Aug 2018 | US |
