Throat specimen collection devices with a bite element for positioning the collection receptacle

Abstract

Throat specimen collection devices and methods of using the same are provided. In certain embodiments, a throat specimen collection device includes i) an occlusal element, and ii) a collection container including an elongate member and a collection member, where when a subject bites on the occlusal element to constrain the element within the mouth of the subject, and the collection container is inserted into the throat to a collection position, the collection position of the collection member is adjusted to 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

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202380085160.8 (22) Application Date 2023.12.01 (30) Priority Data 63 / 429353 2022.12.01 US (85) PCT International Application Entering National Phase Date 2025.06.11 (86) PCT International Application Application Data PCT / US2023 / 082180 2023.12.01 (87) PCT International Application Publication Data WO2024 / 119143 EN 2024.06.06 (71) Applicant Abbott Diagnostics Scarborough Company Address Maine, USA (72) Inventors V. Shapiro B. Johnson B. Gibson (74) Patent Agency China Patent Agency (Hong Kong) Limited 72001 Patent Attorneys Yang Zhong and Wang Lei (51) Int.Cl. A61B 10 / 02 (2006.01) A61B 17 / 32 (2006.01) (54) Title of Invention: Throat Specimen Collection Device with Occlusive Elements for Positioning Collection Container (57) Abstract: A throat specimen collection device and a method of using the same are provided. In some embodiments, the throat specimen collection device includes: i) an occlusive element, and ii) a collection container including an elongated part and a collection part, wherein, when a subject bites down on the occlusive element to restrain the element within the subject's mouth, and the collection container is inserted into the throat to the collection position, the collection part touches the subject's throat and collects a throat specimen from the subject. A method of collecting a throat specimen is also provided, comprising using the throat specimen collection device in the subject's mouth and collecting a throat specimen. Claims (2 pages), Description (9 pages), Drawings (8 pages), CN 120916704 A, 2025.11.07, CN 1 20 91 67 04 A 1. A throat specimen collection device comprising: i) an occlusal element, ii) a collection container including an elongated portion and a collection portion, wherein, when the subject bites down on the occlusal element to restrain the element in the subject's mouth, and the collection container is inserted into the throat to a collection position, the collection portion 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 occlusal element is configured to allow the subject to bite down on the occlusal element to restrain the occlusal element in the subject's mouth.3. The throat specimen collection device of claim 2, wherein when the subject bites on the occlusal element to restrain the occlusal element in the subject's mouth, and the collection container is in the collection position, the collection container touches the subject's throat and collects the throat specimen from the subject. 4. The throat specimen collection device of any one of claims 1 to 3, wherein the collection container is operable within the device such that when the subject bites on the occlusal element, the collection container is in the collection position. 5. The throat specimen collection device of any one of claims 1 to 4, wherein the collection container is movable between an introduction position and the collection position. 6. The throat specimen collection device of claim 5, wherein the collection container, when in the introduction position, is slidable through the occlusal element into the collection position. 7. The throat specimen collection device of any one of claims 1 to 6, wherein the collection container is an elongated component having the collection member at one end. 8. The throat specimen collection device according to any one of claims 1 to 7, wherein the collection component is a cotton swab, a brush head, a rayon swab, a polyester swab, a foam swab, or a flocked swab. 9. The throat specimen collection device according to claim 8, wherein the brush head of the collection component is a block-shaped silicone brush head. 10. The throat specimen collection device according to any one of claims 1 to 9, wherein the occlusal element is configured such that when the subject bites down on the occlusal element using the subject's anterior teeth, the occlusal element restrains the subject's tongue. 11. The throat specimen collection device according to claim 10, wherein when the subject bites down on the occlusal element, the occlusal element restrains the subject's tongue. 12. The throat specimen collection device according to any one of claims 1 to 3, wherein the occlusal element is popsicle-shaped. 13. The throat specimen collection device according to any one of claims 1 to 3, wherein the occlusal element is made of cardboard. 14. The throat specimen collection device according to any one of claims 1 to 3, wherein the occlusal element is made of silicone. 15. The throat specimen collection device according to any one of claims 1 to 3, wherein the occlusal element is flavorful. 16. The throat specimen collection device according to any one of claims 1 to 3, wherein the occlusal element is marked to indicate the appropriate position for the subject to bite down on the occlusal element.Claims 1 / 2 Page 2 CN 120916704 A 17. The throat specimen collection device according to claim 5, wherein, when the subject bites on the occlusal element with the subject's anterior teeth to restrain the occlusal element, the introduction position of the collection container faces the subject's lips. 18. The throat specimen collection device according to any one of claims 1 to 3, wherein the occlusal element is configured such that, in order to restrain the occlusal element in the subject's mouth, the subject bites on the occlusal element with the subject's premolars and / or molars. 19. The throat specimen collection device according to claim 18, wherein, when the subject bites on the occlusal element with the subject's premolars and / or molars to restrain the occlusal element, the introduction position of the collection container is close to the subject's cheek. 20. A method for collecting a throat specimen from a subject using a throat specimen collection device, comprising: i) the subject biting down on the occlusal element of the throat specimen collection device to restrain the occlusal element in the subject's mouth; ii) collecting the throat specimen from the subject while the collection container is in the collection position. 21. The method of claim 20, further comprising moving the collection container from an introduction position to the collection position. 22. The method of claim 21, further comprising introducing the collection container at the introduction position before moving the collection container from the introduction position to the collection position. 23. The method of claim 20, further comprising collecting the collection component to obtain the throat specimen from the collection container. Claims 2 / 2 Page 3 CN 120916704 A Throat specimen collection device with occlusal element for positioning collection container

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 429353, filed December 1, 2022, which is incorporated herein by reference in its entirety. Background Art

[0003] Throat specimen collection typically involves a healthcare professional introducing a throat specimen collection device into the mouth of a subject. The throat specimen collection device is a generally elongated structure having a throat specimen collection container at its 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 generally unpleasant for the subject. For example, some patients, particularly children, exhibit anxiety about the collection device and procedure. Some patients may experience unpleasant vomiting during collection. Therefore, collecting throat specimens from a subject is generally challenging and unpleasant for both the subject and the healthcare professional.

[0005] This disclosure provides a throat specimen collection apparatus and a method for collecting throat specimens using such an apparatus. The throat specimen collection apparatus disclosed herein addresses the problems discussed above regarding existing apparatuses and collection methods.

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

[0007] In some embodiments, a throat specimen collection apparatus includes:

[0008] i) an occlusal element, and

[0009] ii) a collection container including an elongated portion and a collection portion,

[0010] wherein, when a subject bites down on the occlusal element to restrain the element within the subject's mouth, and the collection container is inserted into the throat to the collection position, the collection container touches the subject's throat and collects a throat specimen from the subject.

[0011] In some cases, the collection container is movable between an introduction position and a collection position. The introduction position of the collection container is a position in which the collection container does not touch the subject's throat, for example, when the collection container is introduced into the occlusal element. When in the introduction position, the collection container can be moved to the collection position, in which the collection component touches the subject's throat.

[0012] The collection container may include an elongated component having a collection component at one end. The collection component may be a cotton swab or a brush head, such as a block silicone brush head. The collection component may also be a rayon swab, a polyester swab, a foam swab, or a flocked swab.

[0013] When the subject bites down on the occlusal element using the subject's front teeth, the occlusal element may be configured to hold itself within the subject's mouth. In some devices, the occlusal element also restrains the subject's tongue when the subject bites down on the occlusal element. In such embodiments, the occlusal element may be popsicle-shaped to fit in the subject's mouth, particularly above the subject's tongue. The occlusal element can be made of any suitable material, such as wood, plastic, rubber, cardboard, or silicone. The occlusal element can also be flavored.

[0014] When the subject bites down on the occlusal element, the collection container can be moved to the collection position, where the collection component touches the subject's throat. Alternatively, when the subject bites down on the occlusal element, the collection container can be in an introduction position in which the collection component does not touch the subject's throat. The collection container can then be moved from the introduction position to the collection position. For example, the collection container in the introduction position can be moved through the occlusal element to the collection position.

[0015] A method for collecting a throat specimen using a throat specimen collection device is also provided.Such methods include:

[0016] i) the subject bites down on the occlusal element of the throat specimen collection device to restrain the occlusal element in the subject's mouth;

[0017] ii) collecting a throat specimen from the subject while the collection container is in the collection position.

[0018] In some cases, the method includes moving the throat specimen collection container from the introduction position to the collection position. Brief Description of the Drawings

[0019] Figures 1A-1C show embodiments of the throat specimen collection device.

[0020] Figures 2A-2B show embodiments of the throat specimen collection device.

[0021] Figures 3A-3B show another embodiment of the throat specimen collection device.

[0022] Figures 4A-4B show yet another embodiment of the throat specimen collection device.

[0023] Figure 5 shows an example of a block-shaped silicon brush head that can be used as a collection component. Detailed Description

[0024] A throat specimen collection device and a method for collecting throat specimens are provided. In some embodiments, the throat specimen collection device includes:

[0025] i) an occlusal element, and

[0026] ii) a collection container including an elongated portion and a collection portion,

[0027] wherein, when a subject bites down on the occlusal element to restrain the element, and the collection container is in the collection position, the collection portion touches the subject's throat and collects a throat specimen from the subject.

[0028] A method for collecting a throat specimen using the throat specimen collection device disclosed herein is also provided. The method includes:

[0029] i) a subject bites down on the occlusal element of the throat specimen collection device to restrain the occlusal element in the subject's mouth, and

[0030] ii) collecting a throat specimen from the subject when the collection container is in the collection position.

[0031] Before describing the present disclosure in more detail, it will be understood that the present disclosure is not limited to any particular embodiment described. 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 the present disclosure will be limited only by the appended claims.

[0032] Where 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 the 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 wherein any limit included, excludes, or includes both limits 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 excluding any or both of these included limits is also included in this disclosure.

[0033] 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 practice or testing of this disclosure, some potential and exemplary methods and materials may now be described. Any and all publications mentioned herein are incorporated by reference to disclose and describe methods and / or materials associated with the cited publications. It is understood that, to the extent that there is a conflict, this disclosure supersedes any disclosure of the incorporated publications.

[0034] 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 “apparatus” includes a plurality of such apparatuses. 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 the "negative" limitation.

[0035] The publications discussed herein are provided exclusively for their disclosure prior to the filing date of this application. Furthermore, the date of the publication provided may differ from the actual publication date, 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, the definition or usage of this application shall prevail.

[0036] 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 recounted method may be performed in the order of the recounted events or in any other logically possible order.

[0037] Definitions

[0038] As used herein, the term “throat specimen” refers to a biological specimen obtained from the posterior part of a subject’s mouth at the top portion of the tubes that enter the subject’s stomach and lungs. Throat specimens typically include microorganisms from the subject’s throat and may also contain the subject’s cells, mucus, saliva, and other secretions. The term specimen may be used interchangeably with “throat specimen” and retains the same meaning.

[0039] A “swab” is an absorbent pad or piece of material used to collect a specimen.

[0040] A “occlusal element” refers to a portion of a throat specimen collection device configured to allow the subject to bite and restrain the occlusal element in the subject’s mouth so that the occlusal element remains substantially stationary in the subject’s mouth.

[0041] As used herein, a “collection component” refers to a portion of a collection container configured to obtain a specimen from the subject’s throat.The collection container includes an elongated component with a collection member at one end, which may be a swab for obtaining a specimen from the subject's throat.

[0042] The term "anterior teeth" refers to the teeth at the front of the subject's mouth. These teeth typically include incisors and canines.

[0043] Throat Specimen Collection Device

[0044] As described above, in some embodiments, the throat specimen collection device includes:

[0045] i) an occlusal element, and

[0046] ii) a collection container including the elongated component and the collection member,

[0047] wherein, when the subject bites down on the occlusal element to restrain it, and the collection container is in the collection position, the collection member touches the subject's throat and collects a throat specimen from the subject.

[0048] The collection container may be a physically integrated element of the throat specimen collection device. Alternatively, the collection container may be a physically separate unit, but may be physically fitted into the occlusal element to constitute the throat specimen collection device.

[0049] In some cases, the collection container is in the collection position when the subject bites down on the occlusal element. When 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.

[0050] In some cases, the collection container is movable between an insertion position and a collection position. The insertion position is a position in which the collection container does not touch the subject's throat, for example, when the collection container is inserted into the occlusal element. In the insertion position, the collection container can be moved to the collection position, where the collection component touches the subject's throat. In some cases, the collection container is slidable through the occlusal element to the collection position when in the insertion position.

[0051] In some cases, the collection container is in the insertion position when the subject bites down on the occlusal element, where the collection container does not touch the subject's throat. In the insertion position, the collection container can be moved to the collection position, where the collection container touches the subject's throat and collects a throat specimen from the subject.

[0052] Non-limiting examples of this embodiment are provided in Figures 1A-1C.

[0053] Figure 1A shows an exemplary embodiment of a throat specimen collection device. The device includes an occlusal element 101 and a throat specimen collection container 102. The throat collection container includes a longitudinal rod 105 and a collection member 103.

[0054] As shown in Figure 1B, in this embodiment, when the throat specimen collection device 100 is placed in the mouth of a subject, the subject can use their premolars and / or molars to bite down on the occlusal element 101 to restrain the occlusal element in the subject's mouth. The occlusal element 101 may have a rough surface 104 to provide the subject with a stronger grip on the occlusal element compared to a smooth surface.The rough surface 104 may have ridges, raised dots, recessed dots, undulations, or other suitable patterns that will provide the subject with a stronger grip on the occlusal element.

[0055] As shown in the top panel of Figures 1B and 1C, the throat specimen collection container 102 is in the introduction position 106 indicated by the dashed line in Figure 1C. Therefore, the introduction position 106 includes any position in which the collection component does not touch the subject's throat, i.e., not in the collection position. In the top panel of Figure 1C, the collection component 103 (not shown) is concealed within the occlusal element 101. In the introduction position, the collection component 103 does not touch the subject's throat. A healthcare professional can move the collection container from the introduction position 106 (Figure 1C, top panel, dashed line) to the collection position 107 (Figure 1C, bottom panel, dashed line) by advancing the longitudinal lever 105, which in turn pushes the throat specimen collection container 103 toward the subject's throat and into the throat specimen collection position 107. When in the collection position 107, the collection component 103 touches the subject's throat and collects a throat specimen from the subject, as shown in the bottom panel of FIG1C.

[0056] In cases where the subject uses their premolars and / or molars to bite on the occlusal element to restrain it, the introduction position of the collection container may be towards the subject's cheek. Thus, the collection container may be introduced into the subject's mouth near the subject's cheek, and then the collection container may be moved into the subject's mouth such that the collection component touches the subject's throat.

[0057] In some cases, the collection container is physically separated from the device, for example, as shown in FIG1A and FIG2A. When the subject bites on the occlusal element, the collection container may be introduced into the device at the introduction position where the collection component does not touch the subject's throat. Then, the collection container in the introduction position may be moved into the collection position where the collection component touches the subject's throat and collects a throat specimen from the subject.

[0058] For example, as shown in the top panel of FIG1C, after the subject bites down on the restraining occlusal element, the collection container 102, separated from the occlusal element 101, can be introduced into the introduction position 106. A healthcare professional can move the collection container from the introduction position to the collection position by advancing the longitudinal rod 105, which in turn pushes the collection member 103 toward the subject's throat and into the collection position 107. In the collection position 107, the collection member 103 touches the subject's throat and collects a throat specimen from the subject, as shown in FIG1C.

[0059] Another non-limiting example in which the occlusal element and the collection container are physically separated is also provided in FIG2A-2B as a throat specimen collection device 200. The collection container 202 includes a retainer 208, a longitudinal member 205, and a collection member 203.The collection container can be physically fitted into the occlusal element to form a throat specimen collection device. In this embodiment, the subject bites down on the occlusal element 201 using the subject's front teeth to restrain the occlusal element 201 in the subject's mouth. The collection container 202, physically separated from the occlusal element 201, can be fitted into an insertion position (not shown) where the collection component does not touch the subject's throat. Then, a healthcare professional can move the collection container from the insertion position (not shown) to a collection position 207, where the collection component 203 touches the subject's throat and collects a throat specimen from the subject, as shown in FIG2A.

[0060] The size of the occlusal element 201 can vary depending on the size of the subject's mouth. For example, as shown in FIG2B, a smaller occlusal element 201 (left) can be used for children, while the occlusal element 201 (right) can be used for adults.

[0061] Figures 3A-3B provide another non-limiting example of a throat specimen collection device 300, wherein the collection container 302 is physically separated from the occlusal element 301. In this embodiment, the subject bites down on the occlusal element 301 using the subject's front teeth to restrain the occlusal element in the subject's mouth. The collection container 302, separated from the device, can be inserted into an insertion position 306, in which the collection member 303, hidden within the occlusal element 301, does not touch the subject's throat. A healthcare professional can then move the throat specimen collection container from the insertion position to a collection position (not shown), in which the collection member 303 touches the subject's throat and collects a throat specimen.

[0062] Where the subject bites down on the occlusal element using the subject's front teeth to restrain the occlusal element in the subject's mouth, the insertion position of the throat specimen collection container can be oriented towards the subject's lips. Therefore, the collection container can be introduced into the subject's mouth near the subject's lips, and then the collection container can be moved into the subject's mouth such that the collection component touches the subject's throat.

[0063] In some cases, the collection container may contain more than one collection component. For example, as shown in Figures 3A-3B, the collection container includes two locations where an elongated component can be loaded to contain a throat specimen collection container. Although two such containers are not shown in Figures 3A and 3B, it is readily apparent from these figures that the throat specimen collection container shown in Figures 3A and 3B may contain two elongated components, each having a collection component.

[0064] In some cases, the occlusal element may include a device for adjusting the length of the occlusal element such that the occlusal element can be lengthened or shortened based on the size of the subject's mouth. For example, the occlusal element 401 may include a hinge 408, as shown in Figures 4A-4B.Alternatively, the occlusal element may have a serrated surface 409 that can extend or retract to adjust the length of the occlusal element. The occlusal element 401 restrains the subject's tongue. The throat specimen collection device also includes a throat specimen collection container comprising an elongated portion 402 and a collection portion 403.

[0065] In some cases, the collection container is an elongated portion 502 having a collection portion 503 at one end for collecting a throat specimen. The collection portion may be a cotton swab or a brush head, such as a blocky silicone brush head as shown in FIG. 5. The collection portion may also be a rayon swab, a polyester swab, a foam swab, or a flocked swab.

[0066] In some cases, the occlusal element restrains the subject's tongue when the subject bites down on the occlusal element to restrain it. In some such cases, the occlusal element is popsicle-shaped and covers the subject's tongue to restrain it.

[0067] The occlusal element may be made of any suitable material, such as cardboard, rubber, plastic, or silicone.

[0068] Because the occlusal element can touch the subject's tongue, it can be configured to avoid unpleasant tastes / flavors and / or provide pleasant tastes / flavors. For example, the occlusal element can be flavored by incorporating flavoring substances into the materials used to manufacture the occlusal element. When the occlusal element touches the subject's tongue, such flavoring substances can dissolve into the subject's saliva and provide the subject with a pleasant taste. In particular, an occlusal element with a pleasant taste will facilitate the acquisition of throat specimens from children, as children can be distracted from the unpleasant experience of obtaining a throat specimen and instead enjoy the pleasant taste.

[0069] In some cases, the occlusal element is marked to indicate the proper position for the subject's biting. The proper position for the occlusal element (page 5 / 9 of CN 120916704 A) ensures that when the subject restrains the occlusal element, it is correctly placed in the subject's mouth so that the collection component can properly touch the throat and collect a throat specimen from the subject. Markings on the occlusal element indicate the appropriate position for the subject to bite, to avoid 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.

[0070] Method for collecting a throat specimen

[0071] Some embodiments provide a method comprising:

[0072] i) the subject bites down on the occlusal element of the throat specimen collection device to restrain the occlusal element in the subject's mouth, and

[0073] ii) collecting a throat specimen from the subject when the collection component is in the collection position.

[0074] In some embodiments of the device, the collection container is in the collection position when the subject bites down on the occlusal element to restrain the occlusal element in the subject's mouth. In this position, the collection component of the collection container touches the subject's throat and collects a throat specimen from the subject.Therefore, when using such a device, the method includes i) the subject biting down on the occlusal element of the throat specimen collection device to restrain the occlusal element in the subject's mouth, and ii) collecting the subject's throat specimen when the collection component container is in the collection position.

[0075] Furthermore, in some embodiments of the device, when the subject bites down on the occlusal element, the collection container is in an insertion position in which the collection component does not touch the subject's throat. Then, 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 the throat specimen from the subject. Therefore, when using such a device, the method disclosed herein includes: i) the subject biting down on the occlusal element of the throat specimen collection device to restrain the occlusal element in the subject's mouth, and ii) moving the collection component from the insertion position to the collection position, thereby collecting the subject's throat specimen.

[0076] Furthermore, in some cases, the collection container is a physically separate unit, but can be physically fitted within the occlusal element. In these cases, when the subject bites down on the occlusal element, the collection container can be fitted into the device at the introduction position, where the collection component does not touch the subject's throat. The collection container in the introduction position can then be moved to the 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 disclosed method includes: i) the subject biting down on the occlusal element of the throat specimen collection device to restrain the occlusal element in the subject's mouth, ii) introducing the collection container into the introduction position, and iii) moving the collection component from the introduction position to the collection position, thereby collecting the subject's throat specimen.

[0077] When the collection container is physically separable but can be physically fitted within the occlusal element, the collection container can be physically fitted within the occlusal element before the device is placed in the subject's mouth. In such cases, the method includes: i) physically fitting the collection container into the occlusal element, ii) the subject biting down on the occlusal element of the throat specimen collection device to restrain the occlusal element in the subject's mouth, and iii) collecting the subject's throat specimen.

[0078] A throat specimen can be collected if the collection container within the occlusal element is positioned such that the collection component touches the subject's throat when the subject bites down on the occlusal element. Alternatively, the collection container can be moved from the introduction position to the collection position, whereby the subject's throat specimen is collected, even when the subject bites down on the occlusal element and the collection component does not touch the subject's throat.

[0079] Applicability

[0080] The throat specimen collection device and method for collecting throat specimens disclosed herein are typically used in medical testing and diagnosis. As will be recognized by those skilled in the art, 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 the presence of cells collected from the subject for DNA-based diagnostic purposes. (Instructions for use, pages 6 / 9, CN 120916704 A) Cells collected from the subject can also be tested for the presence of a tumor.

[0081] In some cases, throat specimens from a subject can be tested for infection with pathogens such as viruses, bacteria, or fungi.

[0082] Pathogens that can be tested using throat specimens 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. Diffie) 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.

[0083] Throat specimens from subjects may 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, opioids, and phencyclidine.

[0084] For completeness, various aspects of the invention are set forth in the following numbered clauses:

[0085] Clause 1. A throat specimen collection device comprising:

[0086] i) an occlusal element,

[0087] ii) a collection container including an elongated portion and a collection portion,

[0088] wherein, when the subject bites down on the occlusal element to restrain the element in the subject's mouth, and the collection container is inserted into the throat to a collection position, the collection portion touches the subject's throat and collects the throat specimen from the subject.

[0089] Clause 2. The throat specimen collection device according to Clause 1, wherein the occlusal element is configured to allow a subject to bite down on the occlusal element to restrain the occlusal element in the subject's mouth.

[0090] Clause 3. The throat specimen collection device according to Clause 2, wherein when the subject bites on the occlusal element to restrain the occlusal element in the subject's mouth, and the collection container is in the collection position, the collection container touches the subject's throat and collects the throat specimen from the subject.

[0091] Clause 4. The throat specimen collection device according to any one of Clauses 1 to 3, wherein the collection container is operable within the device such that when the subject bites on the occlusal element, the collection container is in the collection position.

[0092] Clause 5. The throat specimen collection device according to any one of Clauses 1 to 4, wherein the collection container is movable between an introduction position and the collection position.

[0093] Clause 6. The throat specimen collection device according to Clause 5, wherein the collection container, when in the introduction position, is slidable through the occlusal element into the collection position.

[0094] Clause 7. The throat specimen collection device according to any one of Clauses 1 to 6, wherein the collection container is an elongated component having the collection member at one end.

[0095] Clause 8. The throat specimen collection device according to any one of Clauses 1 to 7, wherein the collection member is a cotton swab, a brush head, a rayon swab, a polyester swab, a foam swab, or a flocked swab.

[0096] Clause 9. The throat specimen collection device according to Clause 8, wherein the brush head of the collection member is a block-shaped silicone brush head. Specification 7 / 9 pages 10 CN 120916704 A

[0097] Clause 10. The throat specimen collection device according to any one of Clauses 1 to 9, wherein the occlusal element is configured such that when the subject bites down on the occlusal element using the subject's anterior teeth, the occlusal element is restrained in the subject's mouth.

[0098] Clause 11. The throat specimen collection device according to Clause 10, wherein the occlusal element restrains the subject's tongue when the subject bites down on the occlusal element.

[0099] Clause 12. The throat specimen collection device according to any one of Clauses 1 to 3, wherein the occlusal element is popsicle shaped.

[0100] Clause 13. The throat specimen collection device according to any one of Clauses 1 to 3, wherein the occlusal element is made of cardboard.

[0101] Clause 14. The throat specimen collection device according to any one of Clauses 1 to 3, wherein the occlusal element is made of silicone.

[0102] Clause 15. The throat specimen collection device according to any one of Clauses 1 to 3, wherein the occlusal element has a flavor.

[0103] Clause 16. A throat specimen collection device according to any one of Clauses 1 to 3, wherein the occlusal element is marked to indicate an appropriate position for the subject to bite down on the occlusal element.

[0104] Clause 17. A throat specimen collection device according to Clause 5, wherein the introduction position of the collection container faces the subject's lips when the subject bites down on the occlusal element with the subject's anterior teeth to restrain the occlusal element.

[0105] Clause 18. A throat specimen collection device according to any one of Clauses 1 to 3, wherein the occlusal element is configured such that the subject bites down on the occlusal element with the subject's premolars and / or molars in order to restrain the occlusal element in the subject's mouth.

[0106] Clause 19. A throat specimen collection device according to Clause 18, wherein the introduction position of the collection container is close to the subject's cheek when the subject bites down on the occlusal element with the subject's premolars and / or molars to restrain the occlusal element.

[0107] Clause 20. A method of collecting a throat specimen from a subject using a throat specimen collection device, comprising:

[0108] i) the subject biting down on the occlusal element of the throat specimen collection device to restrain the occlusal element in the subject's mouth;

[0109] ii) collecting the throat specimen from the subject while the collection container is in the collection position.

[0110] Clause 21. The method of Clause 20, further comprising moving the collection container from an introduction position to the collection position.

[0111] Clause 22. The method of Clause 21, further comprising introducing the collection container at the introduction position before moving the collection container from the introduction position to the collection position.

[0112] Clause 23. The method of Clause 20, further comprising collecting the collection component to obtain the throat specimen from the collection container.

[0113] Although the foregoing disclosure has been described in considerable detail by way of illustration and example for purposes of clarity, it will be readily apparent to those skilled in the art, and in light of the teachings of this disclosure, that certain changes and modifications may be made to this disclosure without departing from the spirit or scope of the appended claims.

[0114] 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 expressly described or shown herein, which embody the principles of this disclosure and are included within the spirit and scope of its specification on pages 8 / 9 of CN 120916704 A.Furthermore, all instances and conditional language described herein are primarily intended to help the reader understand the principles of this disclosure and the ideas contributed by the inventors to further the development of the art, and are to be interpreted as not being limited to such specific instances and conditions. Furthermore, 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. Moreover, it is intended that such equivalents include both currently known equivalents and future-developed equivalents, i.e., any element developed that performs the same function regardless of its structure. Furthermore, nothing disclosed herein is intended to be intended for publication, whether or not such disclosure is expressly stated in the claims.

[0115] 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 explicitly invoked only if the exact phrase “device for…” or “step for…” is used 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. Instruction manual page 9 / 9 12 CN 120916704 A Figure 1A Figure 1B Instruction manual drawing page 1 / 8 13 CN 120916704 A Figure 1C Instruction manual drawing page 2 / 8 14 CN 120916704 A Figure 2A Instruction manual drawing page 3 / 8 15 CN 120916704 A Figure 2B Instruction manual drawing page 4 / 8 16 CN 120916704 A Figure 3A Instruction manual drawing page 5 / 8 17 CN 120916704 A Figure 3B Instruction manual drawing page 6 / 8 18 CN 120916704 A Figure 4A Instruction manual drawing page 7 / 8 19 CN 120916704 A Figure 4B Figure 5 Instruction manual drawing page 8 / 8 20 CN 120916704 A.

Claims

1. A throat specimen collection device comprising: i) a bite element, ii) a collection container comprising an elongated member and a collection member, wherein when the subject bites down on the bite element to restrain the element in the subject's mouth and the collection container is inserted into the throat to a collection position, the collection member touches the subject's throat and collects the throat specimen from the subject.

2. The throat specimen collection device of claim 1, wherein, The bite element is configured to allow a subject to bite on the bite element to restrain the bite element in the subject's mouth.

3. The throat specimen collection device of claim 2, wherein, When the subject bites on the bite element to restrain the bite element in the subject's mouth and the collection container is in the collection position, the collection container touches the subject's throat and collects the throat specimen from the subject.

4. The throat specimen collection device of any one of claims 1 to 3, wherein, The collection container is fitted within the device such that when the subject bites on the bite element, the collection container is in the collection position.

5. The throat specimen collection device of any one of claims 1 to 4, wherein, The collection container is movable between an introduction position and the collection position.

6. The throat specimen collection device of claim 5, wherein, The collection container is slidable through the bite element into the collection position when in the introduction position.

7. The throat specimen collection device of any one of claims 1 to 6, wherein, The collection container is an elongated member having the collection member at one end.

8. The throat specimen collection device of any one of claims 1 to 7, wherein, The collection member is a cotton swab, a brush head, a rayon swab, a polyester swab, a foam swab, or a flocked swab.

9. The throat specimen collection device of claim 8, wherein, The brush head of the collection member is a block silicon brush head.

10. The throat specimen collection device of any one of claims 1 to 9, wherein, The bite element is configured such that when the subject bites down on the bite element using the subject's front teeth, the bite element is restrained in the subject's mouth.

11. The throat specimen collection device of claim 10, wherein, The bite element restrains the subject's tongue when the subject bites down on the bite element.

12. The throat specimen collection device according to any one of claims 1 to 3, wherein, The bite element is ice-lolly shaped.

13. The throat specimen collection device according to any one of claims 1 to 3, wherein, The bite element is made of cardboard.

14. The throat specimen collection device according to any one of claims 1 to 3, wherein, The bite element is made of silicone.

15. The throat specimen collection device according to any one of claims 1 to 3, wherein, The bite element is flavored.

16. The throat specimen collection device according to any one of claims 1 to 3, wherein, The bite element is marked to indicate the proper position for the subject to bite down on the bite element.

17. The throat specimen collection device of claim 5, wherein, The introduction position of the collection container is towards the subject's lips when the subject bites on the bite element using the subject's front teeth to restrain the bite element.

18. The throat specimen collection device according to any one of claims 1 to 3, wherein, The bite element is configured such that to restrain the bite element in the subject's mouth, the subject bites on the bite element using the subject's premolars and / or molars.

19. The throat specimen collection device of claim 18, wherein, The collection container introduction position is close to the subject's cheek when the subject bites on the bite element using the subject's premolars and / or molars to restrain the bite element.

20. A method of collecting a throat specimen from a subject using a throat specimen collection device comprising: i) the subject biting down on the bite element of the throat specimen collection device to restrain the bite element in the subject's mouth, ii) collecting the throat specimen from the subject when the collection container is in the collection position.

21. The method of claim 20, further comprising moving the collection container from an introduction position to the collection position.

22. The method of claim 21, further comprising introducing the collection container at the introduction position prior to moving the collection container from the introduction position to the collection position.

23. The method of claim 20, further comprising collecting the collection component to obtain the throat specimen from the collection container.

Images