WO2022104433A1

WO2022104433A1 - Mucus collection device

Info

Publication number: WO2022104433A1
Application number: PCT/AU2021/051385
Authority: WO
Inventors: Eric BERT; Simon LOGSDAIL; Rafael DE SOUZA; Joshua GUTHRIE
Original assignee: 3DMEDiTech Pty Ltd
Priority date: 2020-11-19
Filing date: 2021-11-19
Publication date: 2022-05-27

Abstract

Embodiments relate to a mucus collection device or swab comprising a handle connected to a head. The head comprises a central hub and a plurality of protrusions extending radially away from the hub. Each pair of adjacent ones of the plurality of protrusions defines an open channel extending at least partially around the hub between the pair of adjacent protrusions. For example, the protrusions may comprise a plurality of discs arranged in parallel extending away from the central hub. The mucus collection device may be used to collect a fluid sample (such as bodily fluids, saliva, vaginal fluid/mucus or cervical mucus, for example) from a patient for testing, and may form part of a testing kit, including a vial to contain at least part of the collection device along with the sample, for example.

Description

"Mucus collection device"

Technical Field

[0001] Embodiments generally relate to a mucus collection device or swab and a kit comprising the mucus collection device. The mucus collection device may be used to collect a fluid sample (such as bodily fluids, saliva, vaginal fluid/mucus or cervical mucus, for example) from a patient for testing. For example, saliva may be collected to test a patient for the presence of a virus, such as the COVID- 19 virus. Other applications include the collection of vaginal or cervical mucus for analysis, such as HPV testing, for example.

Background

[0002] Various techniques and devices are used for collecting saliva samples and other mucus samples from patients. For example, flocked swabs or funnel/cup type devices.

[0003] However, some devices are difficult to use without spilling saliva/mucus, and the volumes of saliva or mucus collected with flocked swabs are sometimes insufficient for certain tests.

[0004] It is desired to address or ameliorate one or more shortcomings or disadvantages associated with existing saliva collection devices or to at least provide a useful alternative.

[0005] Throughout this specification the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

[0006] Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present disclosure as it existed before the priority date of each of the appended claims.

Summary

[0007] Some embodiments relate to a mucus or saliva collection device or swab comprising a handle connected to a head, the head comprising a central hub and a plurality of protrusions extending radially away from the hub, wherein each pair of adjacent ones of the plurality of protrusions defines an open channel extending at least partially around the hub between the pair of adjacent protrusions.

[0008] The mucus collection device or swab may comprise a saliva collection device or a cervical mucus swab, for example. The swab may also be suitable for collecting samples or specimens of other bodily fluids and types of mucus, including respiratory tract mucus, digestive mucus, saliva, or gastrointestinal tract mucus, for example.

[0009] In some embodiments, the mucus or saliva collection device may further comprise a break-off portion or neck connecting and extending between the handle and the head. The break-off portion may be connected to the handle by a breakpoint portion having a smaller diameter than the handle and the break-off portion. This may allow separation of the head and break-off portion from the handle to facilitate accommodation of the head and break-off portion in a vial to contain a saliva sample for testing, for example.

[0010] In some embodiments, the plurality of protrusions includes at least three of the protrusions. For example, the plurality of protrusions may include 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or more protrusions.

[0011] In some embodiments, each of the plurality of protrusions is substantially similar. The protrusions may define any suitable shape. For example, round, flat, tapered, disc- shaped, elliptical, obround, rectangular, concave, convex, helical, or any suitable combination of shapes.

[0012] In some embodiments, each of the plurality of protrusions is continuous with the rest of the protrusions, such that the channels defined between each adjacent pair of protrusions form a single continuous channel. For example, the protrusions may cooperate to define a helical thread.

[0013] The mucus or saliva collection device may be formed as a single contiguous piece of material. For example, the mucus or saliva collection device may be formed by additive manufacturing, 3D printing, Selective Laser Sintering (SLS), Stereolithography (SLA), Direct Light Processing (DLP) or injection moulding.

[0014] The mucus or saliva collection device may be formed of any suitable material, including polymers, biocompatible polymers, medical grade polymers, UV cured photopolymers, acrylics, epoxies, polyesters, urethanes, silicones, polystyrenes, Acrylonitrile butadiene styrene (ABS), lower ductility polypropylenes, nylon or nylon 12, for example.

[0015] The surface finish of the head may have an average roughness (Ra) in the range of 0.01pm to 100pm, 1pm to 50pm, 2pm to 40pm, 3pm to 30pm, 5pm to 25pm, 10pm to 20pm, 13 pm to 17pm, or about 15pm, for example.

[0016] A volume of each channel defined between adjacent protrusions may be in the range of 5pL to 50pL, lOpL to 30pL, 15pL to 25pL, 18pL to 22pL, or about 20pL, for example.

[0017] An open volume of the head, defined by the combined volume of all of the channels defined between adjacent protrusions, may be in the range of lOpL to 2000pL, 20pL to lOOOpL, 50pL to 500pL, lOOpL to 500pL, 150pL to 350pL, 200pL to 300pL, lOOpL to 150pL, 150pL to 200pL, 200pL to 250pL, 250pL to 300pL, 300pL to 350pL, or about 200pL, for example. [0018] A solid volume of the head may be in the range of lOOpL to 5000pL, 200pL to 2000pL, 500pL to 1500pL, 750pL to 1250pL, or about lOOOpL, for example.

[0019] A head envelope volume, defined by a prismatic envelope extending the length of the head with an axial cross-sectional profile corresponding to a maximum radial extent of the protrusions, may be in the range of lOOpL to 5000pL, 200pL to 2000pL, 500pL to 1500pL, 750pL to 1250pL, or about lOOOpL, for example.

[0020] The open volume, as a proportion of the head envelope volume, may be in the range of 5% to 80%, 10% to 50%, 15% to 35%, 20% to 30%, or about 25%, for example.

[0021] A ratio between a solid volume of the head and an open volume of the head, defined relative to a prismatic envelope extending the length of the head with an axial cross-sectional profile corresponding to a maximum radial extent of the protrusions (i.e., the open volume corresponding to the difference between the head envelope volume and the solid volume), may be in the range of 1 to 8, 2 to 6, 3 to 5, about 4, or about 3, for example.

[0022] In some embodiments, the protrusions are evenly distributed in a longitudinal direction along the length of the head. The protrusions may be longitudinally distributed with a pitch of at least 1mm, at least 1.5mm, at least 2mm, or in the range of 1mm to 4mm, 1.5mm to 3mm, 1.5mm to 2.5mm, 1.8mm to 2.2mm, or about 2mm, for example.

[0023] An average gap distance between the adjacent protrusions may be in the range of 1mm to 2.5mm, 1.2mm to 2.3mm, 1.5mm to 2mm, about 1.7mm or about 2mm, for example.

[0024] A maximum diameter of the head may be in the range of 4mm to 20mm, 4mm to 12mm, 6mm to 10mm, or about 8mm, for example. In some embodiments, the maximum diameter of the head is less than 20mm, less than 15mm, less than 13mm, less than 12mm, or less than 10mm, for example.

[0025] A ratio between a minimum diameter of the hub and the maximum diameter of the head may be in the range of 15% to 70%, 15% to 50%, 20% to 40%, 25% to 35%, or about 30%.

[0026] The length of the head may be in the range of 10mm to 45mm, 15mm to 35mm, 20mm to 30mm, about 25mm, or about 23mm.

[0027] The surface area of the head may be in the range of 400mm² to 4000mm², 500mm² to 3500mm², 600mm² to 3000mm², 700mm² to 2500mm², 800mm² to 2000mm², 1000mm² to 1500mm², 1200mm² to 1300mm², or about 1250mm².

[0028] Some embodiments relate to a test kit comprising a mucus or saliva collection device according to any one of the described embodiments.

[0029] The test kit may further comprise a vial containing a transport medium and configured to receive and enclose part of the mucus or saliva collection device.

[0030] In some embodiments, a length of the vial is similar to a total length of the head and break-off portion of the saliva collection device when separated from the handle.

[0031] In some embodiments, the handle comprises a closure configured to engage and close a vial with the head disposed within the vial.

Brief Description of Drawings

[0032] Embodiments will now be described, for exemplary purposes only, with reference to the drawings, in which: [0033] Figure 1A is a side view of a mucus or saliva collection device according to some embodiments;

[0034] Figure IB is a close-up side view of a head of the device of Figure 1A;

[0035] Figures 1C is a close-up perspective views of the head of the device of Figure 1A;

[0036] Figure ID is a close-up side view of a head of the device of Figure 1A illustrating features in further detail;

[0037] Figure IE is a distal end view of the device of Figure 1A;

[0038] Figure IF is a lateral cross-section of the head of the device of Figure 1 A illustrating the hub and protrusions of the head according to some embodiments;

[0039] Figure 1G is a proximal end view of the device of Figure 1A;

[0040] Figure 1H is a close-up side view of a breakpoint portion of the device of Figure 1A, according to some embodiments;

[0041] Figure 2 is a schematic diagram of a test kit comprising a mucus or saliva collection device according to some embodiments;

[0042] Figure 3A is a perspective view of a head of a mucus or saliva collection device according to some embodiments;

[0043] Figure 3B is an end view of the head of the device of Figure 3A;

[0044] Figure 3C is a side view of the head of the device of Figure 3 A;

[0045] Figure 3D is a top view of the head of the device of Figure 3A; [0046] Figure 3E is a cross-sectional side view of the head of the device of Figure 3A;

[0047] Figure 4A is a perspective view of a head of a mucus or saliva collection device according to some embodiments;

[0048] Figure 4B is an end view of the head of the device of Figure 4A;

[0049] Figure 4C is a side view of the head of the device of Figure 4A;

[0050] Figure 4D is a cross-sectional side view of the head of the device of Figure 4A;

[0051] Figure 5 A is a perspective view of a head of a mucus or saliva collection device according to some embodiments;

[0052] Figure 5B is an end view of the head of the device of Figure 5A;

[0053] Figure 5C is a side view of the head of the device of Figure 5A;

[0054] Figure 5D is a top view of the head of the device of Figure 5A;

[0055] Figure 5E is a cross-sectional side view of the head of the device of Figure 5A;

[0056] Figure 6A is a perspective view of a head of a mucus or saliva collection device according to some embodiments;

[0057] Figure 6B is an end view of the head of the device of Figure 6A;

[0058] Figure 6C is a side view of the head of the device of Figure 6A;

[0059] Figure 7A is a side view of a mucus collection device, according to some embodiments; [0060] Figure 7B is a close up side view of the head of the mucus collection device of Figure 7A;

[0061] Figure 7C is a proximal end view of the mucus collection device of Figure 7A;

[0062] Figure 7D is a cross-sectional view of the head of the mucus collection device of Figure 7A, through section A-A indicated in Figure 7C;

[0063] Figure 7E is a close up perspective view of the head of the mucus collection device of Figure 7A;

[0064] Figure 8 is a close up side view of a breakpoint portion, according to some embodiments;

[0065] Figure 9A is a perspective view of a mucus collection device, according to some embodiments;

[0066] Figure 9B is a second perspective view of the mucus collection device of Figure 9A;

[0067] Figure 9C is a side view of the mucus collection device of Figure 9A;

[0068] Figure 9D is a close-up side view of a closure of the mucus collection device of Figure 9A;

[0069] Figure 10 is a close-up side view of an alternative closure for the mucus collection device of Figure 9A;

[0070] Figure 11 A is a close-up side view of an alternative closure for the mucus collection device of Figure 9A defining a gasket seat;

[0071] Figure 1 IB is a close-up side view of the closure of Figure 11A including a gasket disposed in the gasket seat; [0072] Figure 12 is a side view of an alternative mucus collection device with a breakaway handle;

[0073] Figure 13A is a side view of a mucus collection device with an alternative breakaway handle; and

[0074] Figure 13B is a perspective view of the device of Figure 13A.

Description of Embodiments

[0075] Embodiments generally relate to a mucus or saliva collection device or swab and a kit comprising the mucus or saliva collection device. The swab or device may be used to collect a fluid sample from a patient for testing. For example, mucus or saliva may be collected to test for the presence of a virus or other biological indicators.

[0076] Some embodiments described herein are referred to as a saliva collection device, but each of the various embodiments may have other applications and may be suitable for use in collecting other fluid samples, including bodily fluids, mucus, vaginal fluids, cervical mucus, respiratory tract mucus, digestive mucus, saliva, or gastrointestinal tract mucus, for example..

[0077] Each of the features described in relation to certain embodiments herein may be combined with other features described in relation to other embodiments to form additional embodiments encompassed by the scope of the claims.

[0078] Referring to figures 1A to 1H, a swab or saliva collection device 100 is shown, according to some embodiments. All dimensions in the present disclosure are provided for exemplary purposes only.

[0079] The saliva collection device 100 comprises a handle 101 connected to a head 110. The head 110 comprises a central hub 114 and a plurality of protrusions 112 extending radially away from the hub 114 relative to a longitudinal axis 102 of the saliva collection device 100. [0080] Each pair of adjacent ones of the plurality of protrusions 112 (for example, protrusions 112a and 112b in Figure IB) defines an open channel 116 extending at least partially around the hub 114 between the pair of adjacent protrusions 112.

[0081] In some embodiments, the saliva collection device 100 may further comprise a break-off portion or neck 105 connecting and extending between the handle 101 and the head 110. The break-off 105 portion may be connected to the handle by a breaknotch or breakpoint portion 106 having a smaller diameter than the handle 101 and the break-off portion 105. This may allow separation of the head and break-off portion from the handle to facilitate accommodation of the head and break-off portion in a vial to contain a saliva sample for testing, for example.

[0082] In some embodiments, the saliva collection device 100 may comprise a tapered portion 118 between the head 110 and the break-off portion 105, as shown in Figures IB and ID.

[0083] In some embodiments, the plurality of protrusions includes at least three of the protrusions. The saliva collection device 100 shown in Figures 1A to 1H comprises 12 protrusions, but different numbers of protrusions may be used for different applications that may require a particular range of saliva collection volume. For example, the plurality of protrusions may include 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or more protrusions.

[0084] In some embodiments, each of the plurality of protrusions 112 is substantially similar. Though the protrusions 112 may differ from each other in other embodiments.

[0085] The protrusions 112 may define any suitable shape. For example, round, flat, tapered, disc- shaped, elliptical, obround, rectangular, concave, convex, helical, or any suitable combination of shapes. Some alternative protrusions shapes are illustrated in Figures 3 to 6, for example. [0086] The protrusions 112 of the saliva collection device 100 shown in Figures 1 A to 1H are substantially disc shaped. Each protrusion 112 has a disc-shaped body 120 defining tapered surfaces 122 on either side of the body 120, which taper to form a ridge 124 at the furthest extent of the protrusion 112 from the hub 114. The ridge 124 may be rounded.

[0087] The tapered surfaces 122 define side walls of the open channel 116 between each pair of adjacent protrusions 112. The protrusions 112 extend away from the hub 114 on either side of a valley 126 where the protrusions 112 are connected to the hub 114. The valley 126 and connections between protrusions 112 and hub 114 may be rounded or radiused.

[0088] The taper angle of the tapered surfaces 122 may be in the range of 1° to 45°, 5° to 30°, 10° to 15°, or about 12.5° from perpendicular to the longitudinal axis 102, for example. The ridges 124 and valleys 126 may be rounded with a radius in the range of 0.1mm to 1mm, 0.2mm to 0.8mm, 0.3mm to 0.6mm, or about 0.3mm, for example.

[0089] The tapered surfaces 122 and rounded ridges 124 and valleys 126 may facilitate certain manufacturing procedures associated with different fabrication methods, such as mould removal after injection moulding, or excess powder removal after selective laser sintering, for example.

[0090] The saliva collection device 100 may be formed as a single contiguous piece of material. For example, the saliva collection device 100 may be formed by additive manufacturing, 3D printing, Selective Laser Sintering (SLS), Stereolithography (SLA), Direct Light Processing (DLP) or injection moulding.

[0091] For example, the saliva collection device 100 may be formed with selective laser sintering using EOS P396 (Electro Optical Systems). Tensile strength may be lesser in the z-direction when building up a part with selective laser sintering. Therefore, it may be preferable to fabricate the saliva collection device 100 with the longitudinal axis 102 aligned horizontally, i.e., in the x-y plane perpendicular to the z- direction.

[0092] Alternatively, various elements of the saliva collection device 100 may be fabricated separately and connected together by welding or adhesive bonding, for example.

[0093] The saliva collection device may be formed of any suitable material, including polymers, biocompatible polymers, medical grade polymers, UV cured photopolymers, acrylics, polystyrenes, Acrylonitrile butadiene styrene (ABS), lower ductility polypropylenes, nylon or nylon 12, for example.

[0094] The surface finish of the head may have an average roughness (Ra) in the range of 0.01pm to 100pm, 1pm to 50pm, 2pm to 40pm, 3pm to 30pm, 5pm to 25pm, 10pm to 20pm, 13 pm to 17pm, or about 15pm, for example.

[0095] A volume of each channel defined between adjacent protrusions may be in the range of 5pL to 50pL, lOpL to 30pL, 15pL to 25pL, 18pL to 22pL, or about 20pL, for example.

[0096] A depth of each channel 116 may be in the range of 1mm to 10mm, 2mm to 5mm, 0.5mm to 3.5mm, 1mm to 2mm, at least 0.5mm, at least 1mm, about 1mm or about 1.5mm, for example.

[0097] An average width of each channel 116 may be in the range of 0.5mm to 5mm, 1mm to 4mm, 2mm to 3mm, 1mm to 2mm, 1.5mm to 2.5mm, or about 2mm, for example.

[0098] An open volume of the head, defined by the combined volume of all of the channels defined between adjacent protrusions, may be in the range of lOpL to lOOOpL, 50pL to 500pL, lOOpL to 500pL, 150pL to 350pL, 200pL to 300pL, lOOpL to 150pE, 150pE to 200pE, 200pE to 250pE, 250pE to 300pE, 300pE to 350pE, or about 200pE, for example.

[0099] The volume of each channel and/or the number of protrusions may be modified to change the total open volume to achieve a specified range of saliva collection volume required for a specific test. The collected saliva volume may be less than the total open volume of the saliva collection device 100, as saliva collected in the channels 116 between the protrusions 112 may form a meniscus between the ridges 124 or between the tapered surfaces 122.

[0100] The expected saliva collection volume as a proportion of the total open volume may be in the range of 30% to 100%, 50% to 95%, 60% to 90%, 70% to 80%, or about 75%, for example. This proportion may vary depending on the particular geometry and dimensions of the protrusions 112 and channels 116 defined therebetween.

[0101] A solid volume of the head may be in the range of lOOpL to 5000pL, 200pL to 2000pL, 500pL to 1500pL, 750pL to 1250pL, or about lOOOpL, for example.

[0102] A head envelope volume, defined by a prismatic envelope extending the length of the head with an axial cross-sectional profile corresponding to a maximum radial extent of the protrusions, may be in the range of lOOpL to 5000pL, 200pL to 2000pL, 500pL to 1500pL, 750pL to 1250pL, or about lOOOpL, for example.

(NOTE: For the saliva collection device 100 with circular disc protrusions 112 shown in Figures 1A to 1H, the prismatic envelope would be a cylinder the length of the head 110 with a diameter corresponding to the maximum diameter of the protrusions 112 taken at the ridge 124).

[0103] The open volume, as a proportion of the head envelope volume, may be in the range of 5% to 80%, 10% to 50%, 15% to 35%, 20% to 30%, or about 25%, for example. [0104] A ratio between a solid volume of the head and an open volume of the head, defined relative to a prismatic envelope extending the length of the head with an axial cross-sectional profile corresponding to a maximum radial extent of the protrusions (i.e., the open volume corresponding to the difference between the head envelope volume and the solid volume), may be in the range of 1 to 8, 2 to 6, 3 to 5, about 4, or about 3, for example.

[0105] The surface area of the head 110 may be in the range of 400mm² to 4000mm², 500mm² to 3500mm², 600mm² to 3000mm², 700mm² to 2500mm², 800mm² to 2000mm², 1000mm² to 1500mm², 1200mm² to 1300mm², or about 1250mm².

[0106] In some embodiments, the protrusions 112 are evenly distributed in a longitudinal direction along the length of the head. The protrusions 112 may be longitudinally distributed with a pitch (from one ridge 124 to the next ridge 124 in an axial direction) of at least 1mm, at least 1.5mm, at least 2mm, or in the range of 1mm to 4mm, 1.5mm to 3mm, 1.5mm to 2.5mm, 1.8mm to 2.2mm, about 3mm, or about 2mm, for example.

[0107] An average gap distance between the adjacent protrusions 112 may be in the range of 1mm to 2.5mm, 1.2mm to 2.3mm, 1.5mm to 2mm, about 1.7mm or about 2mm, for example.

[0108] A maximum diameter of the head 110 may be in the range of 4mm to 20mm, 4mm to 12mm, 6mm to 10mm, or about 8mm, or about 5mm, for example. In some embodiments, the maximum diameter of the head 110 is less than 20mm, less than 15mm, less than 13mm, less than 12mm, less than 10mm, less than 8mm, less than 7mm, less than 6mm, or less than 5mm, for example. The maximum diameter of the head 110 may be designed for accommodation in a standard vial or test tube, such as a vial with an inner diameter of 13mm 8mm, or 6.8mm, for example.

[0109] A ratio between a minimum diameter of the hub 114 and the maximum diameter of the head 110 may be in the range of 15% to 70%, 15% to 50%, 20% to 40%, 25% to 35%, 30% to 50%, 35% to 45%, 38% to 42%, about 40%, or about 30%, for example.

[0110] A ratio between the pitch spacing of the protrusions 112 and the maximum diameter of the head 110 may be in the range of 5% to 100%, 20% to 90%, 30% to 80%, 40% to 70%, 45% to 65%, 50% to 60%, 55% to 65%, about 50%, about 55%, or about 60%, for example.

[0111] The length of the head 110 may be in the range of 10mm to 45mm, 15mm to 35mm, 20mm to 30mm, about 30mm, about 25mm, or about 23mm, for example.

[0112] The length of the saliva collection device 100 may be in the range of 100mm to 200mm, or 120mm to 175mm, for example.

[0113] The break-off portion 105 may have a length in the range of 25mm to 60mm, or 30mm to 50mm, for example.

[0114] The combined length of the head 110 and break-off portion 105 may be in the range of 40mm to 150mm, 50mm to 100mm, 60mm to 80mm, or less than 150mm, less than 120mm, less than 100mm, less than 80mm, less than 75mm, less than 50mm, or about 75mm or about 50mm, for example. The head 110 and break-off portion 105 may be configured to be accommodated within a standard vial, with a combined length of the head 110 and break-off portion 105 being less than an internal enclosed length of a standard vial.

[0115] The handle 101 and break-off portion 105 may have similar or different thicknesses in the range of 1.5mm to 3.5mm, or 2mm to 3mm.

[0116] The breakpoint portion 106 may have a reduced diameter compared with the handle 101 and break-off portion 105 to concentrate stress in the breakpoint portion 106 to facilitate separation of the break-off portion 105 from the handle 101 and into a vial, for example to contain a saliva sample. A transition 107 between the handle 101 and breakpoint portion 106 may be tapered or radiused to promote breaking closer to the break-off portion 105. An alternative breakpoint portion is described below in relation to Figure 8, for example.

[0117] The breakpoint portion 106 may have a diameter in the range of 0.8mm to 1.5mm, 1mm to 1.4mm, 1mm to 2mm, 1.3mm to 1.6mm, about 1.6mm, about 1.3mm, or about 1.2mm, for example.

[0118] All recited dimensions are for exemplary purposes only, and may vary in some embodiments, depending (for example) on the selection of material and fabrication method, and the resulting yield strength and flexibility will determine suitable thicknesses for the handle 101, break-off portion 105 and breakpoint portion 106.

[0119] The head 110 and protrusions 112 may be substantially rigid. However, in some embodiments, based on material selection, the head 110, hub 114, and/or protrusions 112 may be configured to be flexible.

[0120] The total length of the break-off portion 105 and head 110 may be designed for accommodation within a standard sized vial for containment of the saliva sample, such as less than 100mm, less than 75mm, or less than 50mm, for example.

[0121] The saliva collection device 100 may be used by inserting the head 110 in a patient’s mouth; asking them to suck or coat the head 110 in saliva; and then removing the saliva collection device 100 from the patient. Once the saliva has been collected on the head 110, the head 110 and break-off portion 105 may be inserted into a vial and the handle 101 bent down against a rim of the vial so as to break the break-off portion away from the handle 101. This allows the head 110, neck 111 and break-off portion 105 to be stored in the vial while the handle 101 is discarded.

[0122] Referring to Figure 2, a test kit 200 is shown according to some embodiments. The test kit 200 comprises a saliva collection device 100 according to any one of the described embodiments. [0123] The saliva collection device 100 may be enclosed in a sterile package 210, which may be sterilized with an autoclave, gamma radiation, or Ethylene oxide sterilization.

[0124] The test kit 200 may further comprise a vial 220 containing a transport medium and configured to receive and enclose part of the saliva collection device 100. The vial 220 may comprise a certain volume of transport medium (e.g., 2-3mL). For example, the transport medium may comprise saline, Universal Transport Medium, liquid amines, or Viral Transport Medium, depending on the application.

[0125] A length of the vial 220 may be similar to or slightly larger than a total length of the saliva collection device head 110 and break-off portion 105 when separated from the handle 101.

[0126] The test kit 200 may further comprise a sample package 230 (such as a biohazard bag, for example) to receive the vial 220 containing the saliva collection device 110 once the saliva sample has been taken. The test kit 200 may further comprise a procedure package 202 to accommodate the saliva collection device 100, sterile package 210, vial 220 and sample package 230. The procedure package 202 may or may not be sterilised depending on the application of the test kit 200.

[0127] Referring to Figures 3 to 6, various alternative designs of the head 110 are shown according to some embodiments, for the purposes of example only. Dimensions are also given for example only. It will be understood that variously shaped protrusions 112 of different shapes, proportions and spacing may be designed in different embodiments without departing from the scope of the claims following this detailed description of certain embodiments illustrated for exemplary purposes.

[0128] Figures 3A to 3E show a head 110 with concave obround protrusions 112, which each define a cavity 301 on one side, as shown in perspective 3A and crosssection 3E, and channels 116 between the protrusions 112. [0129] Figures 4A to 4D show a head 110 with circular dish-shaped protrusions 112, which each define a concave surface 401 on one side, as shown in perspective 4 A and cross-section 4D, and channels 116 between the protrusions 112.

[0130] Figures 5A to 5E show a head 110 with elliptical dish-shaped protrusions 112, which each define a concave surface 501 on one side, as shown in perspective 5A and cross-section 5E, and channels 116 between the protrusions 112.

[0131] In some embodiments, each of the plurality of protrusions 112 may be continuous with the rest of the protrusions 112, such that the channels 116 defined between each adjacent pair of protrusions 112 form a single continuous channel.

[0132] For example, the protrusions may cooperate to define a helical thread, as shown in Figures 6 A to 6C.

[0133] Each protrusion 112 (e.g., protrusions 112a, 112b, 112c) connects to and is continuous with the next adjacent protrusion 112 (e.g., protrusions 112a, 112b, 112c) to form a continuous thread 612. The thread is shown with a pitch in the range of 2mm to 4mm, for example. Each channel 116 connect to each adjacent channel 116 (e.g., channels 116a, 116b, 116c) to form a single continuous channel 616, which (in some embodiments) extends from one end of the head 110 to the other.

[0134] The head 110 may comprise flat or parallel end portions 601 and 602 that define ends of the channel 616, as shown in Figure 6C.

[0135] In various other embodiments, the head 110 and protrusions 112 may comprise any suitable shape or combinations of shapes, and a head 110 may comprise a combination of different protrusions 112 to define differently shaped channels 116.

[0136] Referring to Figures 7A to 7E, a mucus collection device or swab 700 is shown according to some embodiments. The mucus collection device 700 shares many similar features collection device 100, with like features indicated with like reference numerals, and may embody any of the features described in relation to collection device 100, in a similar range of dimensions as set out in relation to collection device 100. One suitable configuration of dimensions is indicated in drawings 7A and 7B, for example.

[0137] The mucus collection device 700 comprises a handle 101 connected to a head 110. The head 110 comprises a central hub 114 and a plurality of protrusions 112 extending radially away from the hub 114 relative to a longitudinal axis 102 of the mucus collection device 700.

[0138] Each pair of adjacent ones of the plurality of protrusions 112 defines an open channel 116 extending at least partially around the hub 114 between the pair of adjacent protrusions 112.

[0139] The mucus collection device 700 may further comprise a break-off portion or neck 105 connecting and extending between the handle 101 and the head 110. The break-off 105 portion may be connected to the handle by a break- notch or breakpoint portion 106 having a smaller diameter than the handle 101 and the break-off portion 105. This may allow separation of the head and break-off portion from the handle to facilitate accommodation of the head and break-off portion in a vial to contain a mucus sample for testing, for example.

[0140] In some embodiments, the mucus collection device 700 may comprise a tapered portion 118 between the head 110 and the break-off portion 105, as shown in Figures 7B and 7D.

[0141] In some embodiments, the plurality of protrusions includes at least three of the protrusions. The mucus collection device 700 shown in Figures 7A to 7H comprises 12 protrusions, but different numbers of protrusions may be used for different applications that may require a particular range of mucus collection volume. For example, the plurality of protrusions may include 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or more protrusions. [0142] In some embodiments, each of the plurality of protrusions 112 is substantially similar. Though the protrusions 112 may differ from each other in other embodiments.

[0143] The protrusions 112 of the mucus collection device 700 shown in Figures 7A to 7E are substantially similar to the protrusions of collection device 100 shown in Figures 1A to ID, and may comprise any of the features and dimensions described in relation to collection device 100. In other embodiments, the protrusions 112 may define other geometries, such as those shown in Figures 3A to 6C, for example, or any other suitable geometries.

[0144] The mucus collection device 700 may comprise a rounded tip 710, which may define a distal end of the head 110 and the mucus collection device 700. The rounded tip 710 may facilitate insertion of the head 110 into a passage of a patient for sample collection. For example, the mucus collection device 700 may be used for the collection of vaginal fluid or cervical mucus, and the rounded tip 710 may reduce discomfort for the patient.

[0145] The tip 710 may define any suitable geometry including part ellipsoid, paraboloid, prolate spheroid, part spherical or hemispherical, for example. A diameter of the rounded tip may be similar to the lateral extent of the protrusions 112, and may have a similar or identical lateral radius as the protrusions 112. The rounded tip 710 may have an axial extent (i.e., along longitudinal axis 102) which is similar to or within 10%, 20%, 30%, 40%, or 50% more or less than the lateral radius of the tip 710. For example, the rounded tip 710 may define a hemispherical surface with a radius of 4mm, as shown in Figure 7B.

[0146] The mucus collection device 700 may be formed as a single contiguous piece of material. Alternatively, various elements of the mucus collection device700 may be fabricated separately and connected together by welding or adhesive bonding, for example. [0147] The mucus collection device 700 may be formed of any suitable material using any suitable manufacturing technique, such as those described in relation to collection device 100.

[0148] For example, the mucus collection device 700 may be formed with selective laser sintering using EOS P396 (Electro Optical Systems). Tensile strength may be lesser in the z-direction when building up a part with selective laser sintering.

Therefore, it may be preferable to fabricate the mucus collection device 700 with the longitudinal axis 102 aligned horizontally, i.e., in the x-y plane perpendicular to the z- direction.

[0149] The mucus collection device 700 may be provided in a kit 200, as described in relation to Figure 2, and may be sterilised as described above.

[0150] Referring to Figure 8, an alternative breakpoint portion 806 is shown according to some embodiments. The breakpoint portion 806 may comprise similar features to those described in relation to breakpoint portion 106, and may alternatively be included in any one of the described embodiments, mucus or saliva collection devices 100, 700, instead of breakpoint portion 106.

[0151] The breakpoint portion 806 defines a reduced diameter between the handle 101 and the break-off portion 105. The breakpoint 806 may define a continuous curved surface extending between a first edge 801 defining a transition to the handle 101 and a second edge 805 defining a transition to the breakoff portion 105.

[0152] The breakpoint portion 806 may comprise an asymmetric fillet extending between the first edge 801 and the second edge 805. For example, the radius curvature of the asymmetric fillet may vary from 3.3mm at the first edge 801 to 0.6mm at the second edge 805. The narrowest diameter of the breakpoint portion 806 may be 1.6mm, for example. However, any suitable dimensions may be used, as set out in relation to breakpoint portion 106 described above. [0153] Referring to Figures 9A to 9D another mucus collection device 900 is shown, according to some embodiments.

[0154] The mucus collection device 900 shares many similar features collection device 100, with like features indicated with like reference numerals, and may embody any of the features described in relation to collection device 100, in a similar range of dimensions as set out in relation to collection device 100. One suitable configuration of dimensions is indicated in Figure 9C, for example.

[0155] In contrast to device 100, the mucus collection device 900 comprises a closure 920 connected to a head 110. The closure 920 may comprise a lid configured to close a container or vial, such that the head is contained within the vial. The closure 920 may be configured to close a standard vial, such as FluidX 96-Format, 0.9ml Internal Thread, Next-Gen Jacket, Tri-Coded Tube, or Micronic 1.4ml internal thread tube with u-bottom or v-bottom, for example. The closure 920 may also serve as a handle for holding and manipulating the device 900.

[0156] The head 110 comprises a central hub 114 and a plurality of protrusions 112 extending radially away from the hub 114 relative to a longitudinal axis 102 of the mucus collection device 900.

[0157] Each pair of adjacent ones of the plurality of protrusions 112 defines an open channel 116 extending at least partially around the hub 114 between the pair of adjacent protrusions 112.

[0158] The mucus collection device 900 may further comprise a neck 105 connecting and extending between the closure 920 and the head 110. The neck 105 may be relatively short compared to the head 110 depending on the size of the vial in which it is to be contained. In some embodiments, the neck 105 may be omitted with the head 110 being connected directly to the closure 920. [0159] In some embodiments, the plurality of protrusions includes at least three of the protrusions. The mucus collection device 900 shown in Figures 9A to 9C comprises 10 protrusions, but different numbers of protrusions may be used for different applications that may require a particular range of mucus collection volume. For example, the plurality of protrusions may include 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or more protrusions.

[0160] In some embodiments, each of the plurality of protrusions 112 is substantially similar. Though the protrusions 112 may differ from each other in other embodiments.

[0161] The protrusions 112 of the mucus collection device 900 shown in Figures 9A to 9D are substantially similar to the protrusions of collection device 100 shown in Figures 1A to ID, and may comprise any of the features and dimensions described in relation to collection device 100. In other embodiments, the protrusions 112 may define other geometries, such as those shown in Figures 3A to 6C, for example, or any other suitable geometries.

[0162] The mucus collection device 900 may comprise a pointed tip 910, which may define a distal end of the head 110 and the mucus collection device 900. For example, the pointed tip 910 may define a conical surface extending distally from the distal-most protrusion 112. The pointed tip 910 may facilitate insertion of the head 110 into a vial to contain a mucus sample, and reduce or mitigate against a piston effect between the head 110 and the vial. For example, this may be beneficial if the outer diameter of the protrusions is similar to an internal diameter of the vial.

[0163] The closure 920 comprises a lid 922, which may also serve as a handle, and a coupling portion 924. The lid 922 may have a larger diameter than the coupling portion 924 and define a flange or shoulder 923 to abut an opening edge of the vial to facilitate sealing of the vial. In some embodiments, the closure 920 may comprise a sealing portion 930. The sealing portion 930 may be disposed between the lid 922 and coupling portion 924, and may comprise any suitable seal for sealing the vial. [0164] The sealing portion 930 may be configured to seal against the opening edge of the vial, or against an internal surface of the vial. For example, the sealing portion 930 shown in Figure 9D comprises a substantially cylindrical surface with a diameter similar to or slightly larger than an internal diameter of the vial. In some embodiments, the sealing portion 930 may define a tapered surface having a maximum diameter similar to or slightly larger than an internal diameter of the vial.

[0165] The coupling portion 924 may comprise a female threaded surface configured to engage and couple the closure 920 to a standard vial. In some embodiments, the engagement of the coupling portion 924 with the vial may also provide a sufficient seal between the closure 920 and the vial. In some embodiments, the closure 920 may further comprise a sealing portion, as shown in Figures 10, 11A and 11B. In some embodiments, the coupling portion 924 may comprise the sealing portion.

[0166] Figure 10 shows an alternative closure 1020 for the device 900 defining a sealing portion 1030. The sealing portion 1030 may comprise one or more disc protrusions 1032 with an outer diameter similar to that of the vial to seal against. The disc protrusions 1032 may define rounded edges configured to seal against an internal surface of the vial. The disc protrusions 1032 may be integrally formed with the closure 1020.

[0167] The disc protrusions 1032 extend radially from a central sealing portion hub 1034. The sealing portion hub 1034 may have a lesser diameter than a diameter of the coupling portion 924.

[0168] In some embodiments, the disc protrusions 1032 may have a larger diameter than an internal diameter of the vial. In which case, the discs 1032 may be configured to deform when inserted into the vial.

[0169] Figures 11 A and 1 IB show an alternative closure 1120 for the device 900 defining a sealing portion 1130. The sealing portion 1130 may comprise a gasket 1132 (as shown in Figure 1 IB), which may be formed separately to the rest of the closure 1120. The sealing portion 1130 defines a gasket seat 1133 (as shown in Figure 11A) which is configured to support the gasket 1132 to seal against the internal surface of the vial. The gasket 1132 may comprise an o-ring, for example.

[0170] Referring to Figure 12, in some embodiments, the mucus collection device 900 may further comprise a break-away handle 901 to facilitate manipulation of the head 110 in use.

[0171] The break-away handle 901 may be connected to the closure 920 by a breaknotch or breakpoint portion 906 having a smaller diameter than the handle 901. This may allow separation of the head 110 and closure 920 from the handle 901 once the closure 920 is coupled to the vial to close the vial with the head 110 contained in the vial with a mucus sample for testing, for example.

[0172] The break-away handle 901 and breakpoint portion 906 may comprise any of the features described in relation to the handle 101 and breakpoint portion 106 described above in the context of the device 100.

[0173] Referring to Figures 13A and 13B, an alternative break-away handle 1301 for the device 900 is shown, according to some embodiments. The break-away handle 1301 is a similar diameter to the lid 922. The break-away handle 1301 (and/or lid 922) may be substantially cylindrical and hollow, and may define internal and/or external ridges or flutes to contribute to strength and rigidity in the handle 1301 or grip for a user.

[0174] The break-away handle 1301 is connected to the lid 922 by a breakpoint portion 1306. The breakpoint portion 1306 comprises a plurality of connection portions 1307 which cooperate to connect the break-away handle 1301 to the lid 922. The connection portions 1307 may be arranged circumferentially around an edge of the lid 922 adjacent the handle 1301. [0175] The connection portions 1307 may comprise frangible portions configured to connect the break- away handle 1301 to the lid 922 with sufficient strength to support manipulation of the head 110 by a user holding the handle 1301 while being readily disconnected by the user twisting the break-away handle 1301 to break free of the lid 922 once the lid 922 is connected to the vial containing the head 110.

[0176] The mucus collection device 900 may be formed as a single contiguous piece of material. Alternatively, various elements of the mucus collection device 900 may be fabricated separately and connected together by welding or adhesive bonding, for example, or simply assembled without bonding, such as the gasket 1132 in the gasket seat 1133, for example.

[0177] The mucus collection device 900 may be formed of any suitable material or materials using any suitable manufacturing technique, such as those described in relation to collection device 100.

[0178] For example, the mucus collection device 900 may be formed with selective laser sintering using EOS P396 (Electro Optical Systems). Tensile strength may be lesser in the z-direction when building up a part with selective laser sintering.

Therefore, it may be preferable to fabricate the mucus collection device 900 with the longitudinal axis 102 aligned horizontally, i.e., in the x-y plane perpendicular to the z- direction.

[0179] The mucus collection device 900 may be provided in a kit 200, as described in relation to Figure 2, and may be sterilised as described above. The closure 920 may be configured to engage with and close the vial 220 of the kit.

[0180] It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the above-described embodiments, without departing from the broad general scope of the present disclosure. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive. [0181] The table below shows the technical specifications for Nylon 12 material fabricated with selective laser sintering, as one suitable example of material and fabrication technique for manufacturing a mucus or saliva collection device 100, 700, 900 in accordance with the disclosed embodiments, for example only.

Claims

28 CLAIMS:

1. A mucus collection device comprising a handle connected to a head, the head comprising a central hub and a plurality of protrusions extending radially away from the hub, wherein each pair of adjacent ones of the plurality of protrusions defines an open channel extending at least partially around the hub between the pair of adjacent protrusions.

2. The mucus collection device of claim 1, wherein the plurality of protrusions includes at least three of the protrusions.

3. The mucus collection device of claim 2, wherein a combined volume of all of the channels defined between adjacent protrusions is in the range of lOpL to 2000pL.

4. The mucus collection device of any one of claims 1 to 3, wherein a ratio between a solid volume of the head and an open volume of the head, defined relative to a prismatic envelope extending the length of the head with an axial cross-sectional profile corresponding to a maximum radial extent of the protrusions, is in the range of 1 to 8.

5. The mucus collection device of any one of claims 1 to 4, wherein a volume of each channel defined between adjacent protrusions is in the range of IpL to lOOpL.

6. The mucus collection device of any one of claims 1 to 5, wherein the protrusions are evenly distributed in a longitudinal direction along the length of the head.

7. The mucus collection device of claim 6, wherein the protrusions are longitudinally distributed with a pitch of at least 1mm.

8. The mucus collection device of any one of claims 1 to 7, wherein an average gap distance between the adjacent protrusions is in the range of 1mm to 2.5mm.

9. The mucus collection device of any one of claims 1 to 8, wherein a maximum diameter of the head is in the range of 4mm to 20mm.

10. The mucus collection device of any one of claims 1 to 9, wherein a ratio between a minimum diameter of the hub and the maximum diameter of the head is in the range of 15% to 75%.

11. The mucus collection device of any one of claims 1 to 10, wherein the length of the head is in the range of 10mm to 45mm.

12. The mucus collection device of any one of claims 1 to 11, wherein the surface area of the head is in the range of 400mm² to 4000mm².

13. The mucus collection device of any one of claims 1 to 12, wherein each of the plurality of protrusions is substantially similar.

14. The mucus collection device of any one of claims 1 to 13, wherein the protrusions are round.

15. The mucus collection device of any one of claims 1 to 14, wherein the protrusions are substantially disc shaped.

16. The mucus collection device of any one of claims 1 to 14, wherein each of the plurality of protrusions is continuous with the rest of the protrusions, such that the channels defined between each adjacent pair of protrusions form a single continuous channel.

17. The mucus collection device of any one of claims 1 to 16, further comprising a break-off portion connecting and extending between the handle and the head, the break- off portion being connected to the handle by a breakpoint portion having a smaller diameter than the handle and the break-off portion.

18. The mucus collection device of any one of claims 1 to 17, wherein the mucus collection device is formed as a single contiguous piece of material.

19. The mucus collection device of any one of claims 1 to 18, wherein the mucus collection device is formed of a medical grade polymer.

20. A test kit comprising a mucus collection device according to any one of claims 1 to 19.

21. The test kit of claim 20, further comprising a vial containing a transport medium and configured to receive and enclose part of the mucus collection device.

22. The test kit of claim 21, when directly or indirectly dependent on claim 17, wherein a length of the vial is similar to a total length of the head and break-off portion of the mucus collection device when separated from the handle.

23. Any one of the structures, features, integers and/or elements disclosed herein or indicated in the specification of this application, or any combination of two or more of said structures, features, integers and/or elements.