Throat specimen collection device with tongue depressor for positioning collection container

Abstract

Throat specimen collection devices and methods of using the same are provided. In certain embodiments, a throat specimen collection device includes i) a tongue depressor configured to restrain a subject's tongue, and ii) a collection container including an elongate member and a collection member, where the elongate member is positioned to depress the subject's tongue when the tongue depressor is positioned to depress the subject's tongue and the collection container is in a collection position. The acquisition component touches a subject's throat and acquires a throat specimen from the subject. Also provided is a method of collecting a throat specimen, the method comprising applying the throat specimen collection device to a mouth of a subject and collecting the throat specimen.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 429,365, filed December 1, 2022, which is incorporated by reference herein in its entirety. BACKGROUND

[0003] Collecting a throat specimen typically involves a healthcare professional introducing a throat specimen collection device into a subject’s mouth. The throat specimen collection device is a generally elongated structure with a throat specimen collection container at an end. The healthcare professional introduces the throat specimen collection device into the subject’s open mouth and touches the throat with the collection container.

[0004] These devices and methods are often unpleasant for the subject. For example, certain patients, particularly children, exhibit anxiety about the collection device and process. Certain patients can experience unpleasant vomiting during collection. Thus, collecting a throat specimen from a subject is often challenging and unpleasant for both the subject and the healthcare professional. SUMMARY

[0005] The present disclosure provides throat specimen collection devices and methods of collecting throat specimens using such devices. The throat specimen collection devices disclosed herein address the above-discussed problems with existing devices and collection methodologies.

[0006] The throat specimen collection devices and methods disclosed herein can be used to avoid some of the unpleasant experiences in throat specimen collection. For example, when used on children, the throat specimen collection devices and methods disclosed herein can reduce anxiety in children during throat specimen collection. In addition, the throat specimen collection devices and methods disclosed herein can avoid unpleasant vomiting during collection in certain subjects.

[0007] In certain embodiments, a throat specimen collection device comprises:

[0008] i) a tongue depressor, and

[0009] ii) a collection container comprising an elongated member and a collection member,

[0010] wherein, when the tongue depressor is positioned to depress a subject’s tongue and the collection container is in a collection position, the collection member touches the subject’s throat and collects a throat specimen from the subject.

[0011] The collection container can comprise an elongated member with a collection member at one end. The collection member can be a cotton swab or a brush head, such as a block silicon brush head. The collection member can also be a rayon swab, a polyester swab, a foam swab, or a flocked swab.

[0012] A tongue depressor can be constructed to restrain a subject's tongue. For example, a tongue depressor can be longitudinally flat, cylindrical, or popsicle-shaped to fit in the subject's mouth, particularly above the subject's tongue. The tongue depressor can be made of any suitable material, such as wood, plastic, rubber, cardboard, or silicone. Tongue depressors can also be flavored.

[0013] When the tongue depressor is positioned to restrain the subject's tongue, the collection container can be in the collection position, where the collection component touches the subject's throat. Alternatively, when the tongue depressor is positioned to restrain the subject's tongue, the collection container can be in the insertion position, where the collection component does not touch the subject's throat. The collection container can then be moved from the insertion position to the collection position. For example, the collection container in the insertion position can be moved through the tongue depressor to the collection position.

[0014] In some cases, the collection container in the introduction position can slide into the collection position over the tongue depressor. Such sliding can be achieved via a sliding engagement between the collection container holder and the tongue depressor. In even further embodiments, the collection container is physically separated from the tongue depressor during operation.

[0015] In some cases, throat specimen collection devices include an illuminator element. The illuminator element may be automated or user-operated. Positioned within the collection device, the illuminator element illuminates the inside of the subject's mouth during use, thereby making the subject's mouth more visible and facilitating better control of specimen collection, such as better control over the position of the specimen inside the subject's mouth.

[0016] Methods for collecting throat specimens using a throat specimen collection device are also provided. These methods include:

[0017] i) Positioning the tongue depressor of the throat specimen collection device to restrain the subject's tongue, and

[0018] ii) Collect a throat specimen from the subject while the collection container is in the collection position.

[0019] In some cases, the method involves moving the collection container from the introduction position to the collection position. In other cases, the method involves illuminating the subject's mouth using an illuminator element. Attached Figure Description

[0020] Figure 1 An example of a throat specimen collection device is shown.

[0021] Figure 2 An example of a throat specimen collection device is shown.

[0022] Figure 3 Another embodiment of the throat specimen collection device is shown.

[0023] Figure 4 This is yet another embodiment of the throat specimen collection device.

[0024] Figure 5 This shows an example of a block-shaped silicon brush head that can be used as a collection component.

[0025] Figure 6 This is yet another embodiment of the throat specimen collection device.

[0026] Figure 7 Displayed in operation Figure 6 Throat specimen collection device.

[0027] Figure 8 This illustration shows an embodiment of a throat specimen collection device including an illuminator element.

[0028] Figure 9 show Figure 8 Certain components within an exemplary throat specimen collection device.

[0029] Figure 10 Displayed in operation Figure 8 and Figure 9 An exemplary throat specimen collection device.

[0030] Figure 11 An example of a throat specimen collection device is shown.

[0031] Figure 12 Displayed in operation Figure 11 An exemplary throat specimen collection device. Detailed Implementation

[0032] Provides a throat specimen collection device and a method for collecting throat specimens using the device.

[0033] In some embodiments, the throat specimen collection device includes:

[0034] i) Tongue depressor, and

[0035] ii) A collection container, comprising an elongated component and a collection component.

[0036] Specifically, when the tongue depressor is positioned to depress the subject's tongue and the collection container is in the collection position, the collection component touches the subject's throat and collects a throat specimen from the subject.

[0037] Methods for collecting throat specimens using the throat specimen collection device disclosed herein are also provided. Some of these methods include:

[0038] i) Positioning the tongue depressor of the throat specimen collection device to restrain the subject's tongue, and

[0039] ii) Collect a throat specimen from the subject while the collection container is in the collection position.

[0040] Before describing this disclosure in more detail, it will be understood that this disclosure is not limited to the particular embodiments described, and therefore such particular embodiments may be modified. It will also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting, as the scope of this disclosure will be limited only by the appended claims.

[0041] When a range of values ​​is provided, it is understood that, unless the context explicitly specifies otherwise, each intermediate value (one-tenth of a unit to the lower limit) between the upper and lower limits of the range is also specifically disclosed. Each smaller range between any specified value or intermediate value within the specified range and any other specified or intermediate value within that specified range is included in this disclosure. The upper and lower limits of these smaller ranges may be independently included or excluded from the range, and each range that includes any limit, excludes both limits, or includes both limits within a smaller range is also included in this disclosure, subject to any specifically excluded limits within the specified range. If a specified range includes one or both limits, a range that excludes any or both of these included limits is also included in this disclosure.

[0042] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. While any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this disclosure, some potential and exemplary methods and materials are described herein. Any and all publications mentioned herein are incorporated herein by reference to disclose and describe methods and / or materials relating to the cited publications. It is understood that, to the extent that there is a conflict, this disclosure supersedes any disclosure of the incorporated publications.

[0043] It must be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly specifies otherwise. Thus, for example, a reference to “means” includes a plurality of such means. It should also be noted that claims may be drafted to exclude any element, such as any optional element. In this regard, this statement is intended to serve as a prior basis for the use of exclusive terms such as “uniquely,” “only,” etc., in relation to the recitation of claim elements or the use of “negative” limitations.

[0044] The publications discussed herein refer solely to those published prior to the filing date of this application. Furthermore, the dates of the publications provided may differ from the actual publication dates, which may require independent verification. To the extent that any definition or usage of any term herein conflicts with the definition or usage of any term in the application or reference incorporated herein by reference, this application shall prevail.

[0045] As will be apparent to those skilled in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features that can be readily separated from or combined with features of any of the other several embodiments without departing from the scope or spirit of this disclosure. Any described method may be performed in the order of the described events or in any other logically possible order.

[0046] Definitions

[0047] As used herein, the term "throat specimen" refers to a biological specimen obtained from the posterior part of the subject's mouth at the top of the tubes that lead into the subject's stomach and lungs. A throat specimen typically includes microorganisms from the subject's throat and may also contain the subject's cells, mucus, saliva, and other secretions. The term "specimen" is used interchangeably with "throat specimen" and retains the same meaning.

[0048] A swab is an absorbent pad or piece of material used to collect specimens.

[0049] A "tongue depressor" is a part of a throat specimen collection device that is placed in the subject's mouth to restrain the subject's tongue.

[0050] As used herein, “collection component” refers to a portion of a collection container configured to obtain a specimen from a subject’s throat. The collection container includes an elongated component at one end, which may be a swab, for obtaining a specimen from the subject’s throat.

[0051] In some embodiments, the throat specimen collection device includes a collection container holder. The collection container may be physically fitted into the collection container holder. For example, the collection container may be available as a consumable for use with the throat specimen collection device disclosed herein. The collection container may also be physically integrated into the collection container holder.

[0052] The term “restraining the subject’s tongue” indicates that the tongue depressor covers the subject’s tongue and holds it in place. The subject may still be able to move his / her tongue with some force, but in the absence of any intentional tongue movement by the subject, the tongue depressor may be used by the user (e.g., the subject or the healthcare professional collecting the throat specimen) to hold the subject’s tongue in place with moderate effort.

[0053] Throat specimen collection device

[0054] As described above, in some embodiments, the throat specimen collection device includes:

[0055] i) Tongue depressor, and

[0056] ii) A collection container, comprising an elongated component and a collection component.

[0057] Specifically, when the tongue depressor is positioned to depress the subject's tongue and the collection container is in the collection position, the collection component touches the subject's throat and collects a throat specimen from the subject.

[0058] The collection container can be a physically integrated component of a throat specimen collection device. Alternatively, the collection container can be a physically separate unit, but can be physically fitted into a tongue depressor to form a throat specimen collection device.

[0059] In some cases, the collection container is in the collection position when the tongue depressor is positioned to restrain the subject's tongue. In the collection position, the collection container is positioned such that the collection component touches the subject's throat and collects a throat specimen from the subject.

[0060] In some cases, the collection container can move between an introduction position and a collection position. The introduction position is where the collection component does not touch the subject's throat, for example, when the collection container is introduced into the tongue depressor. The collection container in the introduction position can move to the collection position, where the collection component touches the subject's throat. In some cases, the collection container in the introduction position can slide through the tongue depressor into the collection position.

[0061] In some cases, the collection container in the introduction position can slide over the tongue depressor into the collection position via a slidable engagement between the tongue depressor and the collection container holder.

[0062] In some cases, when the tongue depressor is positioned to restrain the subject's tongue, the collection container is in the insertion position, in which the collection component does not touch the subject's throat. The collection container in the insertion position can be moved to the collection position, in which the collection component touches the subject's throat and collects a throat specimen from the subject.

[0063] Figure 1 The present invention describes a non-limiting example of a throat specimen collection device. In this embodiment, the throat specimen collection device 100 is placed in the mouth of a subject to restrain the subject's tongue. In particular, a tongue depressor 101 may be placed over the subject's tongue to restrain the subject's tongue.

[0064] like Figure 1As shown, the collection container 102 is in the collection position 106, in which the collection component 103 touches the subject's throat. Before the collection component touches the subject's throat, a user (who may be the subject or another person, such as a healthcare professional) may introduce the collection container 102 into the tongue depressor 101 in the introduction position, where the collection component does not touch the subject's throat. The user can then move the collection container from the introduction position to the collection position 106 by pushing the collection container 102 through the tongue depressor 101, thereby pushing the collection component 103 toward the subject's throat and into the collection position 106. In the collection position 106, the collection component 103 touches the subject's throat and collects a throat specimen from the subject. The collection container may also include a knob 107 for gripping the collection container 102, pushing it through the tongue depressor 101, or turning or rotating the collection component 103 while in the collection position 106, thereby facilitating the collection of a throat specimen.

[0065] In some cases, the collection container is physically separated from the tongue depressor, for example, as... Figure 1 and Figure 2 As shown in the image. In some cases, when the tongue depressor is placed in the subject's mouth to restrain the subject's tongue, the collection container can be introduced into the tongue depressor at the introduction position, where the collection component does not touch the subject's throat. The collection container, then in the introduction position, can be moved to the collection position, where the collection component touches the subject's throat and collects a throat specimen from the subject.

[0066] For example, such as Figure 2 As shown, after the tongue depressor is positioned to restrain the subject's tongue, the collection container 202, detached from the tongue depressor 201, can be introduced into the introduction position. A user (who may be the subject or another person, such as a healthcare professional) can move the collection container from the introduction position to the collection position by pressing knob 205, which in turn pushes the collection component 203 toward the subject's throat and into the collection position. In the collection position, the collection component 203 touches the subject's throat and collects a throat specimen from the subject. After collecting the throat specimen, a spring 204 in the collection container 202 facilitates the retraction of the collection container 203 from the collection position.

[0067] Figure 3 and Figure 4 The text provides another non-limiting example of an embodiment in which the tongue depressor and the collection container are physically separated. Figure 3 and Figure 4In this embodiment, collection containers 302 and 402 can be physically fitted into tongue depressors 301 and 401 to form throat specimen collection devices 300 and 400. In these embodiments, tongue depressor 301 or 401 can be used to restrain the subject's tongue. Collection containers 302 or 402, physically separate from tongue depressors 301 or 401, can be fitted into an introduction position in which collection component 303 or 403 does not touch the subject's throat. The user (who may be the subject or another person, such as a healthcare professional) can then move the collection container from the introduction position to the collection position, where collection component 303 or 403 touches the subject's throat and collects a throat specimen from the subject.

[0068] The size of the tongue depressor can vary depending on the size of the subject's mouth. For example, a shorter tongue depressor can be used for children, while a longer tongue depressor can be used for adults.

[0069] In some cases, when a tongue depressor is used to restrain a subject's tongue, the collection container can be introduced towards the subject's lips. Therefore, the collection container can be introduced into the subject's mouth near the lips, and then moved into the subject's mouth so that the collection component touches the subject's throat.

[0070] In some cases, the throat specimen collection container is a longitudinal component 502, which has a collection component 503 at one end for collecting throat specimens. The collection component for collecting throat specimens may be a cotton swab or a brush head, such as... Figure 5 The block-shaped silicon brush head 503 is shown in the image. The collection component can also be a rayon swab, polyester swab, foam swab, or flocked swab.

[0071] In some cases, throat specimen collection devices include a tongue depressor that slidably engages with a collection container holder. Figure 6 and Figure 7 Exemplary embodiments of such throat specimen collection devices are provided. Figure 6 In the throat specimen collection device 600 depicted, a longitudinally oriented and flat tongue depressor 601 is used to restrain the subject's tongue. The tongue depressor 601 has a slidable engagement 602 with a collection container holder 603. The slidable engagement 602 may include an elongated body, such as an elongated cylindrical body, which engages with a collection container holder via a corresponding elongated slot in the collection container holder, the corresponding elongated slot fitting above the elongated body, allowing the collection container holder to slide above the elongated body of the tongue depressor.

[0072] In addition to the slidable engagement, the tongue depressor retainer may also have a rotatable engagement with the tongue depressor. Using such a rotatable engagement, the user can rotate the collection container retainer in the direction indicated by the bidirectional arrow 604. This rotatable movement facilitates the collection of a throat specimen from the subject by scraping the throat with the collection part 606.

[0073] In some cases, the acquisition container is physically fitted onto the acquisition container holder 603. For example, Figure 3 and Figure 4 The acquisition container, shown as 302 or 402, can be physically fitted onto the acquisition container holder 603. Alternatively, the acquisition container 605 can be physically integrated with the acquisition container holder 603.

[0074] Figure 7 Displayed in operation Figure 6 An exemplary embodiment of the throat specimen collection device. When Figure 7 When the device 700 is in operation, the user restrains the subject's tongue using the tongue depressor 701. The collection container 705 is in the insertion position (not shown), in which the collection component 706 does not touch the subject's throat. The user can move the collection container from the insertion position to the collection position, in which the collection component 706 touches the subject's throat to collect a throat specimen. Such movement can be achieved by using the slidable engagement 702 between the two to slide the collection container holder 703 over the tongue depressor, so that the collection container slides over the tongue depressor and the collection component touches the subject's throat to collect a throat specimen.

[0075] When the tongue depressor has a rotatable engagement with the collection container holder, the user can use this rotatable engagement to rotate the collection container in the direction indicated by the bidirectional arrow 604. This rotatable movement facilitates the use of the collection part 606 to scrape the subject's throat, thereby collecting a throat specimen from the subject.

[0076] In some cases, throat specimen collection devices include an illuminator element. Figure 8 This illustrates one such embodiment of a throat specimen collection device. In this embodiment, the throat specimen collection device 800 includes an illumination element 801, such as an LED, which illuminates the inside of the subject's mouth during use. The illumination element can be turned on and off using a switch 804. A collection container 802 may be physically fitted onto or physically integrated with a collection container holder 803.

[0077] Figure 9 show Figure 8Certain components within an exemplary throat specimen collection device. The throat specimen collection device 900 includes an illuminator element 904, which is powered by a power source (such as a battery) 903. The battery is connected to the illuminator element 904 via terminals 901 and 902.

[0078] Figure 10 Displayed in operation Figure 8 and Figure 9 An exemplary throat specimen collection device is described. The user uses switch 1004 to turn on the illumination element 1001 on the throat specimen collection device 1000. When the throat specimen collection device 1000 is placed in the subject's mouth, the illumination element 1001 illuminates the inside of the subject's mouth. The user can then use the collection component 1006 to touch the subject's throat to collect a throat specimen.

[0079] Figure 11 This illustrates another embodiment of the throat specimen collection device. In this embodiment, Figure 10 The throat specimen collection device also includes a tongue depressor. Figure 11 The throat specimen collection device 1100 includes an illuminator element 1101, which can be turned on by a user using a switch 1104. The throat specimen collection device also includes a tongue depressor mounting element 1103, to which a tongue depressor 1102 can be physically fitted. Alternatively, the tongue depressor 1102 can be physically integrated into the throat specimen collection device.

[0080] Figure 12 Displayed in operation Figure 11 An exemplary throat specimen collection device is described. When the throat specimen collection device 1200 is placed in the mouth of a subject, the illuminator element 1201 illuminates the inside of the subject's mouth. The user can turn on the illuminator element 1201 and restrain the subject's tongue using the tongue depressor 1202. The user can then use the physically detachable collection container 1203 to touch the subject's throat and the collection component 1204 to touch the subject's throat to collect a throat specimen.

[0081] In some cases, the tongue depressor used in the throat specimen collection apparatus described herein is popsicle-shaped or rectangular. Rectangular tongue depressors may have rounded corners. Tongue depressors may also be semicircles that match the contours of the subject's teeth. The shapes listed herein are merely illustrative, and any suitable shape may be used that fits in the subject's mouth and effectively restrains the subject's tongue without causing unnecessary discomfort.

[0082] Tongue depressors can be made of any suitable material, such as cardboard, rubber, plastic, or silicone.

[0083] Because a tongue depressor touches the subject's tongue, it can be configured to avoid unpleasant tastes / flavors and / or provide pleasant tastes / flavors. For example, the tongue depressor can be flavored, for instance, by incorporating flavoring substances into the materials used to manufacture it. When the tongue depressor touches the subject's tongue, such flavoring substances dissolve into the subject's saliva and provide a pleasant taste. In particular, a pleasantly flavored tongue depressor will facilitate obtaining throat specimens from children, as children can be distracted from the unpleasant experience of obtaining a throat specimen and instead enjoy the pleasant taste.

[0084] In some cases, the tongue depressor is marked to indicate the proper placement of the tongue depressor in the subject's mouth to restrain the subject's tongue. Proper placement of the tongue depressor ensures that when the subject's tongue is restrained by placing the tongue depressor in the subject's mouth, the collection component can properly reach the throat and collect a throat specimen from the subject. The markings on the tongue depressor indicating the proper placement in the subject's mouth are designed to prevent situations where: 1) the collection container does not reach the subject's throat, thus failing to obtain a throat specimen; or 2) the collection container is too close to the subject's throat, potentially causing injury and / or pain.

[0085] Method of collecting a throat specimen

[0086] This article also provides a method for collecting throat specimens using the throat specimen collection device described herein.

[0087] Therefore, some embodiments provide a method comprising:

[0088] i) Positioning the tongue depressor of the throat specimen collection device to restrain the subject's tongue, and

[0089] ii) Collect a throat specimen from the subject while the collection container is in the collection position.

[0090] As discussed above, in some embodiments of the device, when the tongue depressor is positioned to restrain the subject's tongue, the collection container is in the collection position, in which the collection component touches the subject's throat and collects a throat specimen from the subject. Therefore, when using such a device, the method includes: i) positioning the tongue depressor of the device to restrain the subject's tongue, and ii) collecting a throat specimen from the subject when the collection container is in the collection position.

[0091] Furthermore, in some embodiments of the device, when the tongue depressor is positioned in the subject's mouth to restrain the subject's tongue, the collection container is in an insertion position where the collection component does not touch the subject's throat. The collection container in the insertion position can be moved to a collection position where the collection component touches the subject's throat and collects a throat specimen from the subject. Therefore, when using such a device, the methods disclosed herein include: i) positioning the tongue depressor of the device to restrain the subject's tongue, and ii) moving the collection container from the insertion position to the collection position, thereby collecting a throat specimen from the subject.

[0092] Furthermore, in some cases, the collection container is a physically separate unit, but can be physically fitted into the tongue depressor. In such cases, when the tongue depressor is positioned in the subject's mouth to restrain the subject's tongue, the collection container can be fitted into the tongue depressor at an insertion position, in which the collection component does not touch the subject's throat. The collection container in the insertion position can be moved to a collection position, in which the collection component touches the subject's throat and collects a throat specimen from the subject. Therefore, when using such a device, the method disclosed herein includes: i) positioning the tongue depressor of the throat specimen collection device to restrain the subject's tongue, ii) inserting the collection container into the insertion position, and ii) moving the collection container from the insertion position to the collection position, thereby collecting a throat specimen from the subject.

[0093] In some cases, where the collection container is physically detachable but can be physically fitted into the tongue depressor, the collection container can be physically fitted into the tongue depressor before the tongue depressor is placed in the subject's mouth. In such cases, the methods disclosed herein include: i) physically fitting the collection container into the tongue depressor, ii) positioning the tongue depressor of the device to restrain the subject's tongue, and iii) collecting a throat specimen from the subject.

[0094] If the collection container attached to the tongue depressor is in a position where the tongue depressor is positioned in the subject's mouth to restrain the subject's tongue, the collection component touches the subject's throat. Alternatively, when the tongue depressor is positioned in the subject's mouth to restrain the subject's tongue and the collection component does not touch the subject's throat, the collection container can be moved from the introduction position to the collection position, thereby collecting the subject's throat specimen.

[0095] As described above, some throat specimen collection devices of this disclosure include an illumination element. Therefore, in some embodiments, the methods disclosed herein include activating the illumination element of the throat specimen collection device to illuminate the inside of the subject's mouth.

[0096] Utility

[0097] The throat specimen collection apparatus and methods for collecting throat specimens disclosed herein are typically used in medical testing and diagnosis. As those skilled in the art will recognize, throat specimens from a subject can be tested for infections, such as bacterial or viral infections. Throat specimens from a subject can be tested for DNA-based diagnostics using cells collected from the subject. Cells collected from a subject can also be tested for the presence of tumors.

[0098] In some cases, throat specimens from a subject can be tested to detect infections with pathogens such as viruses, bacteria, or fungi.

[0099] Pathogens that can be tested in throat specimens from subjects include one or more of the following: human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), human papillomavirus (HPV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), polyomavirus BK (BKV), methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile (C. Diff.), and vancomycin-resistant enterococci (VRE). ), adenovirus, Mycobacterium tuberculosis (TB), varicella-zoster virus (VZV), herpes simplex virus (HSV), John Cunningham virus (JCV), enterovirus, lymphogranuloma venereum (LGV), respiratory viral cluster virus (RVP), human herpesvirus 6 (HHV6), Trichomonas vaginalis, Mycoplasma genitalium, norovirus, Zika virus, respiratory syncytial virus (RSV), streptococcal pathogens such as Streptococcus pyogenes and Streptococcus agalactiae, Severe Acute Respiratory Syndrome Coronavirus 2, and influenza virus.

[0100] Throat specimens from test subjects can also be tested for toxicology screening, such as for detecting drugs or other chemicals. Drugs or compounds tested in throat specimens include alcohol, amphetamines, barbiturates, benzodiazepines, cocaine, cannabis, methamphetamine, opioids, and phencyclidine.

[0101] For completeness, various aspects of the present invention are set forth in the following numbered clauses:

[0102] Clause 1. A throat specimen collection device, comprising:

[0103] i) Tongue depressor, and

[0104] ii) A collection container, comprising an elongated component and a collection component.

[0105] Specifically, when the tongue depressor is positioned to depress the subject's tongue and the collection container is in the collection position, the collection component touches the subject's throat and collects the throat specimen from the subject.

[0106] Clause 2. The throat specimen collection device according to Clause 1, wherein the collection container is fitted in the tongue depressor such that when the tongue depressor is placed in the mouth of the subject to restrain the subject's tongue, the collection container is in the throat specimen collection position.

[0107] Clause 3. The throat specimen collection device according to Clause 1 or 2, wherein the collection container is movable between the introduction position and the collection position.

[0108] Clause 4. The throat specimen collection device according to Clause 3, wherein the collection container in the introduction position is slidable through the tongue depressor into the collection position.

[0109] Clause 5. A throat specimen collection device according to any one of Clauses 1 to 4, wherein the collection container includes the longitudinal component having the collection component at one end.

[0110] Clause 6. A throat specimen collection device according to any one of Clauses 1 to 5, wherein the collection component is a cotton swab, a brush head, a rayon swab, a polyester swab, a foam swab, or a flocked swab.

[0111] Clause 7. The throat specimen collection device according to Clause 6, wherein the brush head of the collection component is a block-shaped silicon brush head.

[0112] Clause 8. A throat specimen collection device according to any one of Clauses 1 to 7, wherein the tongue depressor is a longitudinally flat component.

[0113] Clause 9. The throat specimen collection device according to any one of Clauses 1 to 7, wherein the tongue depressor is cylindrical.

[0114] Clause 10. The throat specimen collection device according to any one of Clauses 1 to 7, wherein the tongue depressor is popsicle shaped.

[0115] Clause 11. A throat specimen collection apparatus according to any one of Clauses 1 to 10, wherein the tongue depressor is made of cardboard.

[0116] Clause 12. The throat specimen collection device according to any one of Clauses 1 to 10, wherein the tongue depressor is made of silicone.

[0117] Clause 13. The throat specimen collection device according to any one of Clauses 1 to 10, wherein the tongue depressor is made of plastic.

[0118] Clause 14. The throat specimen collection device according to any one of Clauses 1 to 13, wherein the tongue depressor is flavorful.

[0119] Clause 15. The throat specimen collection device according to any one of Clauses 1 to 14, wherein, when the tongue depressor is positioned to restrain the subject's tongue, the introduction position of the collection container faces the subject's lips.

[0120] Clause 16. A method for collecting a throat specimen from a subject using a throat specimen collection device, comprising:

[0121] i) Positioning the tongue depressor of the throat specimen collection device to restrain the subject's tongue, and

[0122] ii) When the collection container is in the collection position, a throat specimen is collected from the subject.

[0123] Clause 17. The method according to Clause 16, the method further comprising moving the collection container from the introduction location to the collection location.

[0124] Clause 18. The method according to Clause 17, the method further comprising introducing the collection container at the introduction location before moving the collection container from the introduction location to the collection location.

[0125] Clause 19. The method according to any one of Clauses 16 to 18, the method further comprising collecting the collection component to obtain the throat specimen from the collection container.

[0126] Clause 20. A throat specimen collection device, comprising:

[0127] i) A tongue depressor, configured to restrain the subject's tongue, and

[0128] ii) Collect container holder,

[0129] The tongue depressor is slidably engaged with the collection container holder.

[0130] Clause 21. The throat specimen collection device according to Clause 20, wherein the tongue depressor is a longitudinal and flat element for restraining the subject's tongue.

[0131] Clause 22. The throat specimen collection device according to Clause 20 or 21, wherein the slidable engagement includes an elongated body on the tongue depressor, the elongated body engaging with the collection container holder via a corresponding elongated groove, the corresponding elongated groove fitting above the elongated body such that the collection container holder slides above the elongated body of the tongue depressor.

[0132] Clause 23. The throat specimen collection device according to any one of Clauses 20 to 22, the throat specimen collection device further comprising a rotatable engagement between the tongue depressor and the collection container holder.

[0133] Clause 24. The throat specimen collection apparatus according to any one of Clauses 20 to 23, wherein the collection container is physically fitted onto the collection container holder.

[0134] Clause 25. The throat specimen collection apparatus according to any one of Clauses 20 to 23, wherein the collection container and the collection container retainer are physically integrated.

[0135] Clause 26. The throat specimen collection device according to any one of Clauses 20 to 25, wherein the throat specimen collection device further comprises an illuminator element.

[0136] Clause 27. A throat specimen collection device comprising: a collection container holder and an illuminator element.

[0137] Clause 28. The throat specimen collection device according to Clause 27, the throat specimen collection device further comprising a collection container.

[0138] Clause 29. The throat specimen collection apparatus according to Clause 28, wherein the collection container is physically fitted onto the collection container holder.

[0139] Clause 30. The throat specimen collection apparatus according to Clause 28, wherein the collection container and the collection container retainer are physically integrated.

[0140] Clause 31. The throat specimen collection device according to any one of Clauses 27 to 30, wherein the throat specimen collection device further comprises a tongue depressor.

[0141] Clause 32. The throat specimen collection device according to Clause 31, wherein the tongue depressor is physically fitted into the device via mounting elements.

[0142] Clause 33. The throat specimen collection device according to Clause 31, wherein the tongue depressor is physically integrated into the throat specimen collection device.

[0143] Clause 34. A throat specimen collection device according to any one of Clauses 20 to 34, wherein the tongue depressor has one of the following shapes: popsicle shape, rectangle, rectangle with rounded corners, and semicircle matching the contour of the subject's teeth.

[0144] Clause 35. A method for collecting a throat specimen from a subject using a throat specimen collection device, the method comprising:

[0145] i) Position the tongue depressor of the throat specimen collection device to restrain the subject's tongue.

[0146] ii) When the collection container is in the collection position, a throat specimen is collected from the subject.

[0147] Clause 36. The method according to Clause 35, the method further comprising moving the collection container from the introduction location to the collection location.

[0148] Clause 37. The method according to Clause 36, the method further comprising introducing the collection container at the introduction location before moving the collection container from the introduction location to the collection location.

[0149] Clause 38. The method according to any one of Clauses 35 to 37, the method further comprising collecting a collection component to obtain the throat specimen from the collection container.

[0150] Clause 39. The method according to any one of Clauses 38 to 38, wherein the throat specimen collection device includes an illuminator element, and the method includes turning on the illuminator element and positioning the throat specimen collection device in the mouth of the subject to illuminate the mouth of the subject.

[0151] Although the foregoing disclosure has been described in considerable detail by way of illustration and example for purposes of clarity, it will be apparent to those skilled in the art, given the ease with which the teachings of this disclosure are received, that certain changes and modifications may be made to this disclosure without departing from the spirit or scope of the appended claims.

[0152] Therefore, the foregoing is merely illustrative of the principles of this disclosure. It will be appreciated that those skilled in the art will be able to design various arrangements, although not explicitly described or shown herein, which embody the principles of this disclosure and are included within its spirit and scope. Furthermore, all instances and conditional language described herein are primarily intended to assist the reader in understanding the principles of this disclosure and the ideas contributed by the inventors to further development in the art, and are to be interpreted as not being limited to such specific instances and conditions. Moreover, all statements herein that describe the principles, aspects, and embodiments of this disclosure, as well as specific examples thereof, are intended to cover both their structural and functional equivalents. Furthermore, it is intended that such equivalents include both currently known equivalents and future-developed equivalents, i.e., any elements developed that perform the same function regardless of structure. Furthermore, nothing disclosed herein is intended as an attempt to publish, whether or not such disclosure is expressly stated in the claims.

[0153] Therefore, the scope of this disclosure is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of this disclosure are embodied in the appended claims. In the claims, 35 U.S.SC §112(f) is expressly invoked only if the exact phrase "device for..." or "step for..." is recited at the beginning of such a limitation in the claim; if the limitation in the claim does not use such an exact phrase, 35 U.S.SC §112(f) is not invoked.

Claims

1. A throat specimen collection device, comprising: i) Tongue depressor, and ii) A collection container, comprising an elongated component and a collection component. Specifically, when the tongue depressor is positioned to depress the subject's tongue and the collection container is in the collection position, the collection component touches the subject's throat and collects the throat specimen from the subject.

2. The throat specimen collection device according to claim 1, wherein, The collection container is fitted into the tongue depressor such that when the tongue depressor is placed in the subject's mouth to restrain the subject's tongue, the collection container is in the throat specimen collection position.

3. The throat specimen collection device according to claim 1 or 2, wherein, The collection container is movable between the introduction position and the collection position.

4. The throat specimen collection device according to claim 3, wherein, The collection container, located at the introduction position, can slide through the tongue depressor into the collection position.

5. The throat specimen collection device according to any one of claims 1 to 4, wherein, The collection container includes the longitudinal component having the collection component at one end.

6. The throat specimen collection device according to any one of claims 1 to 5, wherein, The collection components are cotton swabs, brush heads, rayon swabs, polyester swabs, foam swabs, or flocked swabs.

7. The throat specimen collection device according to claim 6, wherein, The brush head of the acquisition component is a block-shaped silicon brush head.

8. The throat specimen collection device according to any one of claims 1 to 7, wherein, The tongue depressor is a longitudinally flat component.

9. The throat specimen collection device according to any one of claims 1 to 7, wherein, The tongue depressor is cylindrical.

10. The throat specimen collection device according to any one of claims 1 to 7, wherein, The tongue depressor is popsicle shaped.

11. The throat specimen collection device according to any one of claims 1 to 10, wherein, The tongue depressor is made of cardboard.

12. The throat specimen collection device according to any one of claims 1 to 10, wherein, The tongue depressor is made of silicone.

13. The throat specimen collection device according to any one of claims 1 to 10, wherein, The tongue depressor is made of plastic.

14. The throat specimen collection device according to any one of claims 1 to 13, wherein, The tongue depressor has a flavor.

15. The throat specimen collection device according to any one of claims 1 to 14, wherein, When the tongue depressor is positioned to restrain the subject's tongue, the insertion position of the collection container is toward the subject's lips.

16. A method for collecting a throat specimen from a subject using a throat specimen collection device, comprising: i) Positioning the tongue depressor of the throat specimen collection device to restrain the subject's tongue, and ii) When the collection container is in the collection position, a throat specimen is collected from the subject.

17. The method of claim 16, further comprising moving the collection container from the introduction position to the collection position.

18. The method of claim 17, further comprising introducing the collection container at the introduction location before moving the collection container from the introduction location to the collection location.

19. The method according to any one of claims 16 to 18, the method further comprising collecting the collection component to obtain the throat specimen from the collection container.

20. A throat specimen collection device, comprising: i) A tongue depressor, configured to restrain the subject's tongue, and ii) Collect container holder, The tongue depressor is slidably engaged with the collection container holder.

21. The throat specimen collection device according to claim 20, wherein, The tongue depressor is a longitudinal and flat element used to restrain the subject's tongue.

22. The throat specimen collection device according to claim 20 or 21, wherein, The slidable engagement includes an elongated body on the tongue depressor, which engages with the collection container holder via a corresponding elongated groove, the corresponding elongated groove fitting above the elongated body, allowing the collection container holder to slide above the elongated body of the tongue depressor.

23. The throat specimen collection device according to any one of claims 20 to 22, further comprising a rotatable engagement between the tongue depressor and the collection container holder.

24. The throat specimen collection device according to any one of claims 20 to 23, wherein, The collection container is physically fitted onto the collection container holder.

25. The throat specimen collection device according to any one of claims 20 to 23, wherein, The acquisition container and the acquisition container holder are physically integrated.

26. The throat specimen collection apparatus according to any one of claims 20 to 25, wherein the throat specimen collection apparatus further comprises an illuminator element.

27. A throat specimen collection device, comprising: Collect container holders and lighting components.

28. The throat specimen collection device according to claim 27, wherein the throat specimen collection device further comprises a collection container.

29. The throat specimen collection device according to claim 28, wherein, The acquisition container is physically fitted onto the acquisition container holder.

30. The throat specimen collection device according to claim 28, wherein, The acquisition container and the acquisition container holder are physically integrated.

31. The throat specimen collection device according to any one of claims 27 to 30, wherein the throat specimen collection device further comprises a tongue depressor.

32. The throat specimen collection device according to claim 31, wherein, The tongue depressor is physically fitted into the device via mounting elements.

33. The throat specimen collection device according to claim 31, wherein, The tongue depressor is physically integrated into the throat specimen collection device.

34. The throat specimen collection device according to any one of claims 20 to 34, wherein, The tongue depressor has one of the following shapes: popsicle shape, rectangle, rectangle with rounded corners, and semicircle that matches the contour of the subject's teeth.

35. A method for collecting a throat specimen from a subject using a throat specimen collection device, the method comprising: i) Position the tongue depressor of the throat specimen collection device to restrain the subject's tongue. ii) When the collection container is in the collection position, a throat specimen is collected from the subject.

36. The method of claim 35, further comprising moving the collection container from the introduction position to the collection position.

37. The method of claim 36, further comprising introducing the collection container at the introduction location before moving the collection container from the introduction location to the collection location.

38. The method according to any one of claims 35 to 37, the method further comprising acquiring a collection component to obtain the throat specimen from the collection container.

39. The method according to any one of claims 38 to 38, wherein, The throat specimen collection device includes an illuminator element, and the method includes turning on the illuminator element and positioning the throat specimen collection device in the subject's mouth to illuminate the subject's mouth.

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