Fluid collection unit and related devices and methods

Abstract

Described herein is a fluid collection unit comprising: a container for passively collecting a fluid sample; and a fluid flow path in fluid communication with the container, the fluid flow path passing through the unit for directing the fluid sample from the container to an opposite end of the unit.

Description

[0001] This application is a divisional application of the following application.

[0002] The original application number was 201880026800.7.

[0003] The original application was filed on March 8, 2018.

[0004] Original application title: Fluid collection unit and related apparatus and method Technical Field

[0005] This invention relates to the collection of fluid samples. More specifically, the invention relates in several aspects to a fluid collection unit and related methods and apparatus comprising the fluid collection unit. Background Technology

[0006] Saliva testing devices are known, and typically require the subject to spit saliva into a small tube, which is both difficult and uncomfortable. Furthermore, this usually produces a sample containing many air bubbles. Other conventional devices involve sponges or pads for collecting saliva from the mouth. These require a large amount of saliva, and often saliva needs to be squeezed out of the sponge or pad before use.

[0007] For example, U.S. Patent No. 6,248,598 describes an apparatus representing a device for absorbing material. The apparatus described in this patent is a saliva sampling device comprising a squeeze cup, an absorbent foam swab capable of absorbing a fluid specimen, and a flexible tether attached to the foam swab. The foam swab is used to collect a fluid specimen (such as a saliva sample), and the tether is adapted to allow a user to hygienically pull a saturated foam swab into the squeeze cup, in which the foam swab is compressed; and the absorbed fluid is expelled from the squeeze cup drop by drop. The apparatus may also include a platform with a reagent strip for absorbing the expelled fluid to display test results. The apparatus may also include a separator for dividing the expelled fluid into two or more samples prior to testing, such that one sample can be used for fluid confirmation or subsequent testing. In one embodiment, the squeeze cup includes a tapered cross-section to achieve gradual compression of the foam swab.

[0008] U.S. Patent Application Publication No. 2005 / 0096563 describes an apparatus for collecting and testing spit-out oral fluid samples. The apparatus includes a collection chamber having a sample storage space and a top space, an vent, and a hollow tube in the sample storage space capable of guiding oral fluid from the mouth of an oral fluid donor into the collection chamber. The top space is for storing oral fluid foam, and the vent is for escaping air from the collection chamber as the oral fluid is collected. The tube and collection chamber are permanently connected or detached from a device having a connection mechanism that allows both to be connected. The apparatus may further include a laboratory reagent component for detecting analytes in the oral fluid sample. This apparatus provides a simple means of collecting and testing oral fluid and is particularly suitable for point-of-care testing of oral fluid samples. Alternative compositions are needed to overcome or mitigate at least some of the deficiencies of the prior art, or useful alternatives are required. Summary of the Invention

[0009] According to one aspect, a fluid collection unit is provided, comprising:

[0010] Containers for passively collecting fluid samples; and

[0011] A fluid flow path in fluid communication with the container, the fluid flow path passing through the unit, for guiding the fluid sample from the container to the opposite end of the unit.

[0012] On one hand, the container is contained within a notch in the fluid collection unit.

[0013] On the one hand, the notch is essentially cylindrical.

[0014] In one aspect, the notch includes an open sidewall in fluid communication with the fluid flow path.

[0015] In one aspect, the collection unit further includes a recessed area for guiding fluid toward the container.

[0016] On one hand, the recessed area is formed in the wall of the unit.

[0017] On one hand, the recessed area is substantially parallel to and above the fluid flow path.

[0018] In one aspect, the recessed region includes an open sidewall in fluid communication with the fluid flow path.

[0019] On one hand, the dimensions of the open bottom wall are set to allow sufficient surface pressure so that, in use, fluid will not enter the fluid flow path through the open bottom until the leading edge of the fluid reaches the open bottom as it passes through the fluid flow path.

[0020] On one hand, the dimensions of the open bottom wall are set such that large air bubbles or solid materials can be prevented from entering the fluid flow path.

[0021] In one respect, the fluid flow path includes a proximal constriction.

[0022] In one aspect, the fluid flow path accommodates approximately 10 μl to approximately 200 μl of fluid.

[0023] In one aspect, the fluid flow path accommodates approximately 25 μl to approximately 50 μl of fluid.

[0024] On one hand, the fluid flow path accommodates approximately 40 μl of fluid.

[0025] In one respect, the fluid flow path is in communication with the transverse flow membrane.

[0026] In one respect, the fluid flow path is formed by merging the upper half of the unit with the lower half of the unit.

[0027] On one hand, the unit allows the fluid to be collected in a single step and flow from the proximal end of the unit to the distal end, and into a transverse flow membrane in fluid communication with the unit.

[0028] In one respect, the fluid is oral fluid.

[0029] In one respect, the collection unit further includes a cover.

[0030] On one hand, the cover is completely removable.

[0031] On one hand, the cover is hinged, so that the cover remains attached to the unit when the unit is in use.

[0032] On one hand, the collection unit does not include an absorbent pad or sponge for collecting the fluid.

[0033] On the one hand, the collection unit does not require the addition of buffers or diluents to achieve the fluid flow through the fluid flow path.

[0034] According to one aspect, a transverse flow device comprising the fluid collection unit described herein is provided.

[0035] On one hand, the fluid collection unit can be detached from the transverse flow device.

[0036] On one hand, the device includes a window through which test results can be viewed.

[0037] In one respect, the device is transparent.

[0038] In one respect, the device includes a handle.

[0039] On one hand, the handle is a grooved circle for supporting the thumb or fingers.

[0040] On one hand, the handle is detachable from the device.

[0041] In one aspect, the device includes a transverse flow membrane.

[0042] According to one aspect, a method for collecting samples in one step is provided, the method comprising inserting the collection unit described herein into or near the sample and allowing the sample to be drawn into a fluid flow path.

[0043] In one aspect, the sample is saliva, and the method includes inserting the collection unit into the mouth, such as under the tongue or in a cheek pouch.

[0044] On the one hand, the obtained samples are essentially bubble-free.

[0045] Other features and advantages of the invention will become apparent from the following detailed description. However, it should be understood that while the detailed description and specific examples indicate embodiments of the invention, they are given by way of illustration only, as various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from the aforementioned detailed description. Attached Figure Description

[0046] The present invention will be further understood with reference to the accompanying drawings and the following description, wherein:

[0047] Figure 1 A perspective view of the first embodiment of the transverse flow device described herein is shown.

[0048] Figure 2 exhibit Figure 1 A top view of the transverse flow device.

[0049] Figure 3 exhibit Figure 1 A bottom view of the transverse flow device.

[0050] Figure 4 exhibit Figure 1 A side view of the transverse flow device.

[0051] Figure 5 exhibit Figure 1 Front view of the transverse flow device.

[0052] Figure 6 exhibit Figure 1 Rear view of the transverse flow device.

[0053] Figure 7 exhibit Figure 1 An exploded perspective view of the top of the transverse flow device, with the transverse flow membrane and device cover added.

[0054] Figure 8 exhibit Figure 1 An exploded perspective view of the bottom of the transverse flow device, with the transverse flow membrane and device cover added.

[0055] Figure 9 Display along Figure 1 The cross-sectional view of line 9-9 of the transverse flow device.

[0056] Figure 10 A top plan view of a second embodiment of the transverse flow device described herein is shown.

[0057] Figure 11 exhibit Figure 10 A bottom view of the transverse flow device.

[0058] Figure 12 exhibit Figure 10 A side view of the transverse flow device.

[0059] Figure 13 exhibit Figure 10 Front view of the transverse flow device.

[0060] Figure 14 exhibit Figure 10 Rear view of the transverse flow device.

[0061] Figure 15 exhibit Figure 10 Exploded perspective view of the top and bottom of the transverse flow device.

[0062] Figure 16 exhibit Figure 10 An exploded perspective view of the top of the transverse flow device in the presence of the transverse flow membrane and the device cover.

[0063] Figure 17 This is an exploded top perspective view of a third embodiment of the transverse flow device described herein.

[0064] Figure 18 Display along Figure 17 A cross-sectional view of the fluid collection unit of the transverse flow device, line 18-18.

[0065] Figure 19 exhibit Figure 17 A top view of the transverse flow device without the device cover.

[0066] Figure 20 exhibit Figure 17A bottom view of the transverse flow device without the device cover.

[0067] Figure 21 exhibit Figure 17 A side view of the transverse flow device without the device cover.

[0068] Figure 22 exhibit Figure 17 Front view of the transverse flow device without the device cover.

[0069] Figure 23 exhibit Figure 17 Rear view of the transverse flow device.

[0070] Figure 24 exhibit Figure 17 A perspective view of the main body of the reader of the transverse flow device. Detailed Implementation

[0071] This document describes, in several respects, a fluid collection unit for obtaining fluid samples. The fluid collection unit can advantageously be incorporated as part of a lateral flow device. While the fluid collection units described herein are particularly advantageous for collecting saliva samples, they can be used to collect any type of fluid sample. In certain respects, the fluid collection unit passively collects samples, such as saliva, thus eliminating the need to spit out saliva. The device can be simply placed in a position within the mouth, allowing the user to comfortably push saliva to the top fluid collection opening. In some respects, the fluid collection unit can be placed under the tongue or in the cheek pocket. Through a combination of capillary action and gravity, a sufficient but small amount of saliva will be collected in the unit.

[0072] In this way, the collection unit described herein avoids collecting air bubbles and / or large particles in saliva, which can affect precise volume control and fluid flow that can lead to subsequent test failures. It also avoids the multiple steps required when collecting saliva with a sponge or pad, followed by squeezing the saliva out of the sponge or pad. Due to its high fluid recovery rate and the associated reduction in fluid waste, the fluid collection unit described herein allows for easier fluid collection.

[0073] In several respects, the collection unit and lateral flow device described herein can achieve a one-step operation in which the device is placed in the mouth to collect saliva and obtain test results without the need for additional steps such as removing the sample from a sponge or pad, applying a buffer solution and waiting for more samples to be collected, or waiting for bubbles to settle out of the fluid sample.

[0074] definition

[0075] As used herein, the term "proximal end" refers to the portion of a collection unit or device closer to the end containing the container, while the term "distal end" refers to the portion of a collection unit or device closer to the end containing the handle. The terms "upstream" and "downstream" refer to the flow of fluid from the proximal end (upstream) to the distal end (downstream).

[0076] The term "analyte" is intended to encompass any chemical or biological substance measured quantitatively or qualitatively. Typically, analytes are found in saliva samples. Analytes can include small molecules, proteins, antibodies, DNA, RNA, nucleic acids, carbohydrates, lipids, organic assimilates or metabolites, viral components or intact viruses, bacterial components or intact bacteria, cellular components or intact cells, and their complexes and derivatives. Human salivary gland secretions contain a rich mixture of biochemical substances, electrolytes, proteins, genetic material, polysaccharides, and other molecules. The concentration of each saliva component varies considerably depending on an individual's health condition and the presence of disease (oral or systemic) or drugs. By measuring these components in saliva, it is possible to screen for a wide variety of things, including but not limited to infections, allergies, endocrine disorders, tumors, drug use, and to obtain genetic material for subsequent testing.

[0077] For example, the collection unit described herein has specific uses in point-of-care devices for identifying drug overdose or roadside detection devices for identifying drivers under the influence of alcohol or marijuana. Drugs that can be tested using the collection unit described herein include, but are not limited to, hallucinogens, stimulants, sedatives, depressants, abuse inhalers, hypnotics, and alcohol. According to specific embodiments, one or more analytes to be detected are one or more drugs selected from the group consisting of: alcohol, opiates, cocaine, cannabinoids such as tetrahydrocannabinol (THC), amphetamine, methamphetamine, morphine, benzodiazepines, 1-(1'-phenylcyclohexyl)piperidine (PCP), barbiturates, methadone, and heroin or other opioids with morphine-like effects, such as, but not limited to, codeine, papaverine, noscapine, hydrocodone, or fentanyl. Derivatives or metabolites of these drugs may also be detected.

[0078] The analyte can be a drug of abuse, some of which are listed above, or a drug that is frequently misused and overdosed, such as paracetamol. Additionally, the analyte can be a disease biomarker, such as troponin or carbon-reactive protein. Numerous examples of such biomarkers exist and are well known to those skilled in the art.

[0079] In other respects, the analytes to be tested can be genetic samples, such as those used by 23andMe™ or other DNA testing companies. These companies typically require the end-user to collect a saliva sample and return it to the company for testing. The saliva collection tubes used by these companies are usually the type you have to spit out, which may not be a comfortable experience for the user.

[0080] The term "passive" or "passively" in relation to saliva sample collection aims to exclude active effort by the end user to spit or expel the collection unit. Instead, passive collection means that the collection unit is placed in the mouth, typically under the tongue or in the cheek pouch, and saliva secretions are collected simply by placing the collection unit near the secretions. Some mouth movement will be expected during use, and such movement is covered by the term "passive" provided it is not an active act of spitting into the collection unit.

[0081] In understanding the scope of this application, the articles “a,” “an,” “the,” and “the” are intended to mean the presence of one or more elements. Furthermore, as used herein, the term “comprising” and its derivatives are intended to be open-ended terms that specify the presence of stated features, elements, parts, groups, integers, and / or steps, but do not exclude the presence of other unstated features, elements, parts, groups, integers, and / or steps. The foregoing also applies to words with similar meanings, such as the terms “comprising,” “having,” and their derivatives.

[0082] It should be understood that any aspect described as “comprising” certain components may also be “composed of” or “essentially composed of” (and vice versa), where “composed of” has a closed or limiting meaning, and “essentially composed of” means including the specified components but excluding components other than materials present as impurities, unavoidable materials present as a result of the process for providing the components, and components added for purposes other than achieving the technical effects of the invention.

[0083] It should be understood that any component defined herein as included may be expressly excluded from the claimed invention by means of provisos or negative limitations, whether implicitly or explicitly defined herein. For example, in one aspect, the apparatus of this invention does not use a sponge or collecting pad to absorb saliva as an initial step in the testing method.

[0084] Furthermore, all ranges given in this article include the ends of the ranges as well as any intermediate points, whether or not explicitly stated.

[0085] Finally, degree terms used in this paper, such as “substantially,” “about,” and “approximately,” imply a reasonable amount of deviation from the modified term such that the final result is not significantly altered. These degree terms should be understood to include at least ±5% deviation from the modified term if such deviation does not negate the meaning of the modified word.

[0086] Lateral flow device

[0087] Figures 1 to 9 A first transverse flow device 10 is shown. As shown, device 10 includes a fluid collection unit 12 and a body 14. Body 14 contains a handle 16 and a window 18 through which test results can be visually viewed or read by a machine. Device 10 is typically transparent, but can be any desired color and opacity and combination thereof, as long as the test can still be read. It will be understood that in a fully transparent device 10, the window 18 is optional.

[0088] The fluid collection unit 12 typically comprises an elongated body that includes a recessed region 20 and a container 22. Both the recessed region 20 and the container 22 lead to a fluid flow path 24, which... Figure 8 The fluid flow path 24 is used to guide the fluid sample from container 22 to the transverse flow membrane 26 at the opposite end of collection unit 12.

[0089] In some respects, the volume maintained by the fluid flow path 24 is reasonably chosen to be equal to or greater than the volume required for the accurate functioning of the transverse flow membrane 26. In this way, testing will not begin until a sufficient amount of sample is present in the collection unit 12, because the fluid front must reach the transverse flow membrane 26 for the testing to commence. In several respects, the fluid flow path 24 has a volume of approximately 10 μl to approximately 200 μl, such as approximately 10 μl to approximately 100 μl, such as approximately 25 μl to approximately 50 μl, such as approximately 40 μl.

[0090] Container 22 is typically a cylindrical recess integrally formed within collection unit 12. Container 22 has open sidewalls 28 through which fluid in container 22 can enter fluid flow path 24. Recessed area 20 assists in guiding additional fluid toward container 22.

[0091] As shown in the figure, the recessed region 20 is formed in the wall above the fluid flow path 24 and includes three sloping walls 30 that converge at the open bottom wall 32 adjacent to the fluid flow path 24. As shown in the figure, two of the sloping side walls 30 cooperate to partially form the container 22.

[0092] The dimensions of the open bottom wall 32 of the recessed region 20 are configured to allow surface pressure to stop fluid flow, such that during use, fluid will not enter the fluid flow path 24 through the open bottom wall 32 until the leading edge of the fluid from the container 22 reaches the open bottom wall 32 while passing through the fluid flow path 24. This helps to draw fluid from the recessed region 20 while reducing the possibility of air bubbles entering the fluid flow path 24, or otherwise interrupting the fluid in the fluid flow path 24 with air.

[0093] like Figure 8 and Figure 9 As shown, the fluid flow path 24 includes a constriction 34 near the container 22. The constriction 34 is simply a narrowing of the fluid flow path 24, thereby locally reducing its cross-sectional area. In this way, the constriction 34 increases the capillary force on the fluid surface at the leading edge of the fluid sample in the fluid flow path 24 relative to the remaining surface of the fluid sample. If there is too little fluid in the container 22 upstream of the constriction 34, the fluid in the fluid flow path 24 will not flow, ensuring that testing will not begin without sufficient sample. However, once enough fluid has accumulated in the container 22, the disruption of the fluid surface at the constriction 34 will allow the fluid to continue flowing along the fluid flow path 24. The size of the constriction 34 is chosen to reduce the likelihood of air bubbles entering the fluid flow path 24.

[0094] The collection unit 12 may be integral with the device 10, or it may be detachable from the remainder of the device 10. In some respects, the collection unit 12 is brittlely attached to the device 10 such that it can be easily broken after being used for processing and / or for inserting at least a portion of the device 10 into a reader for measuring test results, because the size of such a reader may not be suitable for the collection unit 12 when attached to the body 14.

[0095] Collection unit 12 typically has the following features: Figure 7 and Figure 8 The cover 36 is shown. The cover 36 is removable, allowing access to the collection unit 12. For hygiene and / or protection reasons, the cover 36 can then be placed back onto the collection unit 12. The cover 36 can be completely removed, or in some respects, it can remain partially attached to the device 10 and / or the collection unit 12 to reduce the possibility of the cover 36 being misplaced or contaminated.

[0096] Device 10 typically includes a handle 16, which, like the collection unit 12, is brittlely attached to device 10 such that the handle 16 can be broken off from the remainder of device 10, and a conventional reader can be used with the remainder of device 10. The handle 16 is typically a round shape with grooves sized for easy operation with the thumb or fingers.

[0097] like Figure 7 and Figure 8 As shown, the device 10 is typically formed by mating upper portions 38 and lower portions 40 to facilitate the fabrication and insertion of the desired transverse flow membrane 26. The device 10 can also be formed as a single unit. As shown, mating fasteners 42 hold the upper portions 38 and lower portions 40 together. The upper portions 38 and lower portions 40 also include guides 44 that securely hold the transverse flow membrane 26 in place, allowing the transverse flow membrane 26 to fluidly communicate with the fluid flow path 24.

[0098] like Figure 7 and Figure 8 As can be seen, the container 22, the recessed area 20, and the fluid flow path 24 are all formed in the upper part 38 of the device 10. It will be understood that one or more of these features may be partially or entirely formed in the bottom 40 of the device 10.

[0099] Figures 10 to 16 A second lateral flow device 110 is shown, which is constructed slightly differently from the first lateral flow device 10, but operates on a similar principle. As shown, device 110 includes a fluid collection unit 112 and a body 114. Body 114 contains a handle 116 and a window 118 through which test results can be visually viewed or read by a machine. Device 110 is typically transparent, but can be any desired color and opacity and combination thereof, as long as the test can still be read. It will be understood that in a fully transparent device 110, the window 118 is optional.

[0100] The fluid collection unit 112 typically comprises an elongated body that includes a recessed region 120 and a container 122. In this respect, the container 122 is more than described above. Figures 1 to 9 The described container 22 is much smaller. Container 122 is merely a small channel or opening leading to the fluid flow path 124. This design effectively reduces the dead volume in the fluid collection unit 112. As mentioned above, the recessed region 120 also leads to the fluid flow path 124. The fluid flow path 124 is used to guide the fluid sample from container 122 to the transverse flow membrane 126 at the opposite end of the collection unit 112. Figure 10 and Figure 16 As shown, container 122 is surrounded by flange 156, which helps to collect fluid samples and guide the fluid samples toward container 122.

[0101] In some respects, the volume maintained by the fluid flow path 124 is reasonably chosen to be equal to or greater than the volume required for the accurate functioning of the transverse flow membrane 126. In this way, testing will not begin until a sufficient amount of sample is present in the collection unit 112, because the fluid front must reach the transverse flow membrane 126 for the test to commence. In several respects, the fluid flow path 124 has a volume of approximately 10 μl to approximately 200 μl, such as approximately 10 μl to approximately 100 μl, such as approximately 25 μl to approximately 50 μl, such as approximately 40 μl.

[0102] Container 122 is typically a smaller vertical channel integrally formed within collection unit 112. Container 122 has an open sidewall 128 through which fluid in container 122 can enter fluid flow path 124. Recessed region 120 assists in directing additional fluid toward container 122.

[0103] As shown, a recessed region 120 is formed in the wall above the fluid flow path 124 and includes three sloping walls 130 that converge at an open bottom wall 132 adjacent to the fluid flow path 124. As shown, two sloping sidewalls 130 cooperate to partially form a container 122, which is also partially formed by sloping protrusions 108.

[0104] The dimensions of the open bottom wall 132 of the recessed region 120 are configured to effectively prevent air bubbles and large particles from entering the fluid flow path 124. This dimension also allows surface pressure to stop the initial fluid flow, ensuring that, in use, fluid will not enter the fluid flow path 124 through the open bottom wall 132 until the leading edge of the fluid from container 122 reaches the open bottom wall 132 as it passes through the fluid flow path 124. This facilitates fluid intake from the recessed region 120 while reducing the likelihood of air bubbles entering the fluid flow path 124, or otherwise interrupting the fluid flow in the fluid flow path 124 with air.

[0105] like Figure 11 , Figure 15 and Figure 16As shown, the fluid flow path 124 includes an vent 135 located near the container 122 in the bottom wall of the fluid flow path. Typically, the opening of the vent 135 is significantly wider than the openings of the container 122 and the open bottom wall 132, thereby allowing for a reduction in surface pressure. For example, the vent 135 is typically about 1.5 to about 2.5 times wider than the openings of the container 122 and / or the open bottom wall 132, such as about 1.5 times, about 1.6 times, about 1.7 times, about 1.8 times, about 1.9 times, about 2.0 times, about 2.1 times, about 2.2 times, about 2.3 times, about 2.4 times, or about 2.5 times wider. In a particular aspect, the vent 135 is typically about 0.8 to about 1.0 mm wide, while the openings of the container 122 and / or the open bottom wall 132 are about 0.3 to about 0.5 mm wide.

[0106] If there is no fluid above the fluid flow path 124, once the fluid flow path 124 is completely or partially filled, the fluid surface formed at the openings of the container 122 and the open bottom wall 132 may stop the downstream flow of fluid in the fluid flow path 124 due to the opposing surface pressures generated by surface tension at the openings of the container 122 and the open bottom wall 132. However, air can enter the fluid flow path 124 through the vent 135, thereby promoting continuous downstream fluid flow in the fluid flow path 124.

[0107] In other words, the fluid normally enters the fluid flow path 124 until there is no more fluid above the fluid flow path 124 at the container 122 or the open bottom wall 132. At this point, the new surfaces formed at the openings of the container 122 and the open bottom wall 132 will stop the fluid flow in the fluid flow path 124 because the fluid flow path 124 is much wider than the openings of the container 122 and the open bottom wall 132. Therefore, the capillary force generated in the downstream direction is less than the opposing capillary force generated by the surfaces at the openings of the container 122 and the open bottom wall 132. The fluid also cannot overcome the capillary force at the vent 135 because the fluid flow path 124 and the vent 135 have similar dimensions. However, if the fluid has reached the transverse flow membrane 126 with stronger capillary forces, then the fluid will be able to overcome the capillary force at the vent 135, causing the fluid to continue flowing towards the transverse flow membrane 126, even if it may still not be able to overcome the opposing capillary forces at the openings of the container 122 and the open bottom wall 132.

[0108] The collection unit 112 may be integrated with the device 110, or it may be detachable from the remainder of the device 110. In some respects, the collection unit 112 is brittlely attached to the device 110 such that it can be easily broken after being used for processing and / or for inserting the remainder of the device 110 into a reader for measuring test results, because the size of such a reader may not be suitable for the collection unit 112 when attached to the body 114.

[0109] Collection unit 112 typically has the following features: Figure 16 The cover 136 is shown. The cover 136 is removable, allowing access to the collection unit 112. For hygiene and / or protection reasons, the cover 136 can then be placed back onto the collection unit 112. The cover 136 can be completely removed, or in some respects, it can remain partially attached to the device 110 and / or the collection unit 112 to reduce the possibility of the cover 136 being misplaced or contaminated.

[0110] Device 110 typically includes a handle 116, which, like the collection unit 112, is brittlely attached to device 110 such that the handle 116 can be broken off from the remainder of device 110, and a conventional reader can be used with the remainder of device 110. The handle 116 is typically a round shape with grooves sized for easy operation with the thumb or fingers.

[0111] like Figure 15 and Figure 16 As shown, the device 110 is typically formed by mating upper portions 138 and lower portions 140 to facilitate the fabrication and insertion of the desired transverse flow membrane 126. The device 110 can also be formed as a single unit. As shown, mating fasteners 142 hold the upper portions 138 and lower portions 140 together. The upper portions 138 and lower portions 140 also include guides 144 that securely hold the transverse flow membrane 126 in place, allowing the transverse flow membrane 126 to fluidly communicate with the fluid flow path 124.

[0112] like Figure 15 and Figure 16 As can be seen, the recessed region 120 and the fluid flow path 124 are formed in the upper part 138 of the device 110. The container 122 is formed in the lower part 140 of the device 110. It will be understood that one or more of these features may be formed partly or entirely by any part 138, 140 of the device 110.

[0113] Figures 17 to 24A third lateral flow device 210 is shown, similar to the second lateral flow device 110, but made in several pieces, making a portion of device 210 removable so that it can be fitted into a conventional reader device. As shown, device 210 includes a holder 202, a reader body 204 consisting of an upper portion 238 and a lower portion 240, and a cover 236 for the reader body 204. When assembled, device 210 includes a fluid collection unit 212 and a body 214, very similar to devices 10 and 110 described above. The body 214 contains a handle 216 and a chamber for holding the reader body 204, which has a window 218 through which test results can be visually viewed or read by machine. Device 210 is typically transparent, but can be any desired color and opacity and combination thereof, as long as the test can still be read. It will be understood that in a fully transparent device 210, the window 218 is optional.

[0114] As described above, the fluid collection unit 212 typically comprises an elongated body containing a recessed region 220 and a container 222. The container 222 is simply a small channel or opening leading to a fluid flow path 224. As described above, the recessed region 220 also leads to the fluid flow path 224. The fluid flow path 224 is used to guide the fluid sample from the container 222 to a transverse flow membrane 226 at the opposite end of the collection unit 212. Figures 17 to 20 As shown, container 222 is surrounded by flange 256, which helps to collect fluid samples and guide the fluid samples toward container 222.

[0115] from Figure 17 and Figure 18 As can be seen, the fluid flow path 224 is formed by tightly fitting the fluid collection portion 206 to the proximal end of the holder 202 and by tightly fitting the top 238 and bottom 240 of the reader body 204. The top 238 and bottom 240 of the reader body 204 include protrusions 246 that overlap with the surface of the fluid flow path 224. This overlap prevents the formation of a gap between the proximal and distal ends of the fluid flow path 224, wherein the proximal end of the fluid flow path 224 is formed by tightly fitting the fluid collection portion 206 to the proximal end of the holder 202, and the distal end of the fluid flow path is formed by tightly fitting the top 238 and bottom 240 of the reader body 204.

[0116] In some respects, the volume maintained by the fluid flow path 224 is reasonably chosen to be equal to or greater than the volume required for the accurate functioning of the transverse flow membrane 226. In this way, testing will not begin until a sufficient amount of sample is present in the collection unit 212, because the fluid front must reach the transverse flow membrane 226 for the test to commence. In several respects, the fluid flow path 224 has a volume of approximately 10 μl to approximately 200 μl, such as approximately 10 μl to approximately 100 μl, such as approximately 25 μl to approximately 50 μl, such as approximately 40 μl.

[0117] Container 222 is typically a smaller vertical channel integrally formed within collection unit 212. Container 222 has an open sidewall 228 through which fluid in container 222 can enter fluid flow path 224. Recessed region 220 assists in guiding additional fluid toward container 222.

[0118] As shown in the figure, a recessed region 220 is formed in the wall above the fluid flow path 224 and includes three inclined walls 230 that converge at an open bottom wall 232 adjacent to the fluid flow path 224. As shown in the figure, two inclined side walls 230 cooperate to partially form a container 222, which is also partially formed by inclined protrusions 208.

[0119] The dimensions of the open bottom wall 232 of the recessed region 220 are configured to allow surface pressure to stop fluid flow, such that during use, fluid will not enter the fluid flow path 224 through the open bottom wall 232 until the leading edge of the fluid from container 222 reaches the open bottom wall 232 as it passes through the fluid flow path 224. This helps to draw fluid from the recessed region 220 while reducing the likelihood of air bubbles entering the fluid flow path 224, or otherwise interrupting the fluid in the fluid flow path 224 with air.

[0120] like Figure 18 and Figure 20As shown, the fluid flow path 224 includes an vent 235 located near the container 222 in the bottom wall of the fluid flow path. Typically, the opening of the vent 235 is significantly wider than the openings of the container 222 and the open bottom wall 232, thereby allowing for a reduction in surface pressure. If there is no fluid above the fluid flow path 224, once the fluid flow path 224 is completely or partially filled, the fluid surfaces formed at the openings of the container 222 and the open bottom wall 232 can stop the downstream flow of fluid in the fluid flow path 224 due to the opposing surface pressures generated by surface tension at the openings of the container 222 and the open bottom wall 232. However, air can enter the fluid flow path 224 through the vent 235, thereby promoting continuous downstream fluid flow in the fluid flow path 224. In other words, fluid normally enters the fluid flow path 224 until there is no more fluid above the fluid flow path 224 at the container 222 or the open bottom wall 232. At this point, the new surface formed at the openings of container 222 and open bottom wall 232 will stop the fluid flow in fluid flow path 224, because fluid flow path 224 is much wider than the openings of container 222 and open bottom wall 232. Therefore, the capillary force generated in the downstream direction is less than the opposing capillary force generated by the surfaces at the openings of container 222 and open bottom wall 232. The fluid also cannot overcome the capillary force at vent 235, because fluid flow path 224 and vent 235 have similar dimensions. However, if the fluid has reached the transverse flow membrane 226, which has stronger capillary forces, then the fluid will be able to overcome the capillary force at vent 235, causing the fluid to continue flowing towards the transverse flow membrane 226, even if it may still not be able to overcome the opposing capillary forces at the openings of container 222 and open bottom wall 232. If the fluid has not yet reached the transverse flow membrane 226 and there is no remaining sample above fluid flow path 224, then the flow will stop until more sample is added. In this way, the configuration of the apparatus ensures that the test will only be initiated when there is a sufficient sample in the apparatus.

[0121] In this regard, the shape and size of the reader body 204 are designed to fit conventional reader devices and are removable from the holder 202 for insertion into the reader device. Once the test is complete, the reader body 204 is removed from the device 210, an optional cover 236 is placed on the reader body 204 to prevent contamination of the reader device, and the reader body 204 is inserted into the reader for measuring the test results. Figure 24 In the image, the reader body 204, along with the cover 236, is shown as separate from the device 210.

[0122] Therefore, it will be understood that the reader body 204 can be disposable, while the holder 202 can be reusable and optionally sterilizable. In this way, a single patient requiring repeated testing can reuse the holder multiple times, or the holder can be sterilized for use between different patients in a clinic or hospital setting. The holder 202, reader body 204, and cap 236 can be made of the same or different materials and can be independently transparent, translucent, or opaque, or a combination thereof.

[0123] like Figure 17 and Figure 20 As shown, the retainer 202 includes an opening region 248 that facilitates the removal of the reader body 204 from the retainer 202. For example, a user can push through the opening region 248 to push the reader body 204 out of the retainer 202. In several aspects, the retainer 202 also includes a protrusion 250 that helps to properly align the reader body 204 in the retainer 202 and optionally provides a fastening engagement that helps to firmly hold the reader body 204 in the retainer 202 until it is desired to be removed by force.

[0124] As described above, the reader body 204 typically has the following features: Figure 17 and Figure 24 The cover 236 is shown. Cover 236 is removable, allowing the reader body 204 to be inserted into and used in the holder 202. Cover 236 can then be placed back onto the reader body 204 when it is removed from the holder 202 for hygiene and / or protection reasons and / or for proper assembly in the reader device. Cover 236 can be completely removed, or in some respects, partially attached to the device 210 and / or the reader body 204 to reduce the possibility of misplacement or contamination.

[0125] The holder 202 typically includes a handle 216, which is typically a circle with a groove, the size of which facilitates operation with the thumb or finger.

[0126] like Figure 17 and Figure 24 As shown, the reader body 204 is typically formed by mating upper portions 238 and lower portions 240 to facilitate the fabrication and insertion of the desired transverse flow membrane 226. The reader body 204 can also be formed as a single unit. As shown, mating fastener components 242 hold the upper portions 238 and lower portions 240 together. The upper portions 238 and lower portions 240 also include guides (not shown) that securely hold the transverse flow membrane 226 in place, allowing the transverse flow membrane 226 to fluidly communicate with the fluid flow path 224.

[0127] like Figure 17 and Figure 18 As shown, the retainer 202 is similarly formed by mating upper portions 252 and lower portions 254. The lower portion 254 includes a handle 216, a body 214, and the lower half of the proximal end of the fluid flow path 224. The upper portion 252 is much smaller than the top portion 254 and includes a recessed area 220 and an open bottom wall 232. These upper portions 252 and lower portions 254 are mated together by friction to form the proximal end of the fluid flow path 224.

[0128] like Figure 17 and Figure 18 As can be seen, the recessed region 220 and the fluid flow path 224 are formed in the upper part 252 of the holder 202. The container 222 is formed in the lower part 254 of the holder 202. It will be understood that one or more of these features may be formed partly or entirely by any part 252, 254 of the holder 202.

[0129] It will be understood that any transverse flow membrane can be used in the apparatus described herein and / or in conjunction with the collection unit described herein. In certain aspects, transverse flow membranes are as described in U.S. Patent Nos. 7,785,865, 8,119,393, or 7,238,538, or International Patent Application Publication Nos. WO 2009 / 143601 or WO 2013 / 155617.

[0130] While the collection units described herein are particularly suitable for collecting saliva samples, it should be understood that they can be used to collect any fluid, such as serum, blood, plasma, cell suspension, cell culture supernatant, saliva, oral fluid, cerebrospinal fluid, amniotic fluid, milk, colostrum, mammary gland secretions, lymph, urine, sweat, tears, gastric juice, synovial fluid, mucus, or combinations thereof.

[0131] Furthermore, the collection units described herein have been intended for use in conjunction with lateral flow assays, where small sample volumes are typically required. However, it should be understood that these collection units can be used to collect saliva for any purpose and can be appropriately sized to collect any desired volume of saliva, which may vary depending on the intended end use. For example, if the saliva is collected for the end use of DNA sequencing, then up to approximately 5 ml of saliva may be collected, such as from approximately 0.5 ml to approximately 5 ml, such as from approximately 1 ml to approximately 3 ml, such as approximately 2 ml.

[0132] As described above, the contraction 34 is typically formed by reducing the cross-sectional area of ​​the fluid flow path 24, such as by increasing the thickness of the top wall of the fluid flow path 24. It will be understood that the contraction 34 can be formed by increasing the thickness of the top and / or bottom walls of the fluid flow path, and the contraction 34 can have any desired shape, such as a gradual or abrupt narrowing of the flow path in the upstream or downstream direction.

[0133] How to use

[0134] In use, the fluid collection units 12, 112, 212 described herein are placed near or in the vicinity of a fluid sample. When the fluid sample is saliva, the fluid collection units 12, 112, 212 are placed in the mouth, such as under the tongue or in the cheek area. However, as saliva is produced in the mouth, the collection units 12, 112, 212 passively collect the saliva without needing to spit it out or otherwise wipe the mouth.

[0135] When fluid is collected in containers 22, 122, and 222, it is drawn into fluid flow paths 24, 124, and 224 via capillary action. When a constriction section 34 is present, it increases capillary forces opposite to the fluid flow direction when insufficient liquid is available, thereby reducing the likelihood of air bubbles entering fluid flow paths 24, 124, and 224. As the leading edge of saliva flows along fluid flow paths 24, 124, and 224, it collects fluid that has entered recessed regions 20, 120, and 220 due to the disruption of fluid surface tension at the open bottom walls 32, 132, and 232, thus preventing fluid in recessed regions 20, 120, and 220 from entering fluid flow paths 24, 124, and 224.

[0136] The dimensions of the open bottom walls 32, 132, and 232 at the bottom of the recessed regions 20, 120, and 220 are designed such that the surface pressure is sufficient to stop fluid from flowing into the fluid flow paths 24, 124, and 224 via the open bottom walls 32, 132, and 232, unless the fluid flow paths 24, 124, and 224 are filled with fluid or until the fluid front in the fluid flow paths 24, 124, and 224 contacts the fluid at the open bottom walls 32, 132, and 232, thereby drawing fluid into the fluid flow paths 24, 124, and 224. This not only reduces the risk of the container becoming clogged by solid materials (such as cells and bacteria) present in the fluid sample, but also reduces the likelihood of air bubbles entering the fluid flow paths 24, 124, and 224. Therefore, when the leading edge of the fluid is drawn in along the fluid flow paths 24, 124, and 224 via capillary action, the liquid surface at the open bottom walls 32, 132, and 232 is removed, allowing the fluid held at the open bottom walls 32, 132, and 232 by surface pressure to be drawn into the fluid flow paths. This increases the efficiency of the collection units 12, 112, and 212 because it can collect fluid from the recessed regions 20, 120, and 220 in addition to the fluid present in the containers 22, 122, and 222.

[0137] When the fluid reaches the end of fluid flow paths 24, 124, and 224, it can enter the transverse flow membranes 26, 126, and 226, where it will be analyzed and the test results can be observed. The fluid may be used in other ways or may be collected and stored for future use.

[0138] The foregoing disclosure generally describes the invention. Changes in form and substitutions of equivalents are considered to be appropriate if circumstances suggest or favor them. Although specific terminology is used herein, such terminology is intended to be descriptive rather than limiting.

[0139] All announcements, patents and patent applications cited above are incorporated herein by reference in their entirety, to the same extent that each individual announcement, patent or patent application is specifically and individually indicated to be incorporated herein by reference in its entirety.

[0140] Although preferred embodiments of the invention have been described in detail herein, those skilled in the art will understand that changes may be made to the invention without departing from the spirit of the invention or the scope of the appended claims.

Claims

1. A fluid collection unit, characterized in that, The fluid collection unit comprises: A container for passively collecting fluid samples, wherein the container includes a substantially cylindrical notch in the fluid collection unit; and A fluid flow path in fluid communication with the container, the fluid flow path passing through the unit, is used to guide the fluid sample from the container to the opposite end of the unit. The fluid flow path includes a proximal constriction near the container, which narrows the fluid flow path, thereby locally reducing its cross-sectional area and reducing the possibility of bubbles entering the fluid flow path. Wherein, the notch includes an open sidewall in fluid communication with the fluid flow path; and The fluid sample is an oral fluid sample.

2. The collection unit according to claim 1, characterized in that, The fluid flow path includes an exhaust port.

3. The collection unit according to claim 2, characterized in that, The vent is located in the bottom wall of the fluid flow path.

4. The collection unit according to claim 3, characterized in that, The vent is located at the proximal end of the fluid flow path.

5. The collection unit according to claim 1, characterized in that, The container further includes a channel in fluid communication with the fluid flow path.

6. The collection unit according to claim 5, characterized in that, The container is formed within an inclined protrusion.

7. The collection unit according to claim 1, characterized in that, The container is surrounded by a flange to guide the fluid sample into the container.

8. The collection unit according to claim 1, characterized in that, It further includes a recessed area for guiding fluid toward the container.

9. The collection unit according to claim 8, characterized in that, The recessed area is formed in the wall of the unit.

10. The collection unit according to claim 9, characterized in that, The recessed area is substantially parallel to and above the fluid flow path.

11. The collection unit according to claim 10, characterized in that, The recessed region includes an open bottom wall that is in fluid communication with the fluid flow path.

12. The collection unit according to claim 11, characterized in that, The dimensions of the open bottom wall are set to allow sufficient surface pressure so that, during use, fluid will not enter the fluid flow path through the open bottom wall until the fluid front reaches the open bottom wall as it passes through the fluid flow path.

13. The collection unit according to claim 12, characterized in that, The dimensions of the open bottom wall are set such that large air bubbles or solid materials can be prevented from entering the fluid flow path.

14. The collection unit according to claim 1, characterized in that, The fluid flow path includes a proximal constriction.

15. The collection unit according to claim 1, characterized in that, The fluid flow path accommodates fluids ranging from 10 μl to 200 μl.

16. The collection unit according to claim 15, characterized in that, The fluid flow path accommodates 25 μl to 50 μl of fluid.

17. The collection unit according to claim 16, characterized in that, The fluid flow path accommodates 40 μl of fluid.

18. The collection unit according to claim 1, characterized in that, The fluid flow path is connected to the transverse flow membrane.

19. The collection unit according to claim 1, characterized in that, The fluid flow path is formed by merging the upper half of the unit with the lower half of the unit.

20. The collection unit according to claim 1, characterized in that, The unit allows the fluid to be collected in a single step and flow from the proximal end of the unit to the distal end, and into a transverse flow membrane in fluid communication with the unit.

21. The collection unit according to claim 1, characterized in that, Further includes a cover.

22. The collection unit according to claim 21, characterized in that, The cover is completely removable.

23. The collection unit according to claim 22, characterized in that, The cover is hinged so that it remains attached to the unit when the unit is in use.

24. The collection unit according to claim 1, characterized in that, The collection unit does not contain an absorbent pad or sponge for collecting the fluid.

25. The collection unit according to claim 11, characterized in that, The collection unit does not require the addition of buffers or diluents to achieve fluid flow through the fluid flow path.

26. A transverse flow device, characterized in that, The lateral flow device includes a fluid collection unit according to any one of claims 1 to 25.

27. The apparatus according to claim 26, characterized in that, The fluid collection unit can be detached from the transverse flow device.

28. The apparatus according to claim 27, characterized in that, The device includes a window through which test results can be viewed.

29. The apparatus according to claim 26, characterized in that, The device is transparent.

30. The apparatus according to claim 26, characterized in that, The device includes a handle.

31. The apparatus according to claim 30, characterized in that, The handle is a grooved circle designed to support the thumb or fingers.

32. The apparatus according to claim 30, characterized in that, The handle is detachable from the device.

33. The apparatus according to claim 26, characterized in that, It includes a transverse flow membrane.

34. A reader body, characterized in that, The reader body is configured to be combined with a fluid collection unit according to any one of claims 1 to 25.

35. The reader body according to claim 34, characterized in that, A fluid flow path includes a fluid flow path in fluid communication with the fluid collection unit, such that the fluid sample can flow from the proximal end of the fluid collection unit to the distal end of the fluid collection unit and into the reader body.

36. The reader body according to claim 35, characterized in that, It includes at least one protrusion, which is used to overlap with the fluid flow path of the fluid collection unit.

37. The reader body according to any claim 34, characterized in that, The reader body includes a window through which test results can be viewed.

38. The reader body according to claim 34, characterized in that, The reader body is transparent.

39. The reader body according to claim 34, characterized in that, The reader body is configured to be combined with the holder.

40. The reader body according to claim 39, characterized in that, The fluid flow path of the fluid collection unit is formed by engaging the proximal end of the retainer with the fluid collection unit.

41. The reader body according to claim 39, characterized in that, The holder includes a handle.

42. The reader body according to claim 41, characterized in that, The handle is a grooved circle designed to support the thumb or fingers.

43. The reader body according to claim 34, characterized in that, It includes a transverse flow membrane.

44. A method for collecting samples in one step, characterized in that, The method includes inserting the collection unit according to any one of claims 1 to 25 alone into or near the sample, or inserting the collection unit in combination with the reader body according to any one of claims 34 to 43 or the device according to any one of claims 26 to 33 into or near the sample, and allowing the sample to be drawn into the fluid flow path.

45. The method according to claim 44, characterized in that, The sample is saliva, and the method includes inserting the collection unit into the mouth.

46. ​​The method according to claim 45, characterized in that, The obtained sample was essentially bubble-free.

47. The method according to claim 45, characterized in that, The method involves inserting the collection unit under the tongue or in a cheek pouch.

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