Liquid Collection Device
A liquid specimen collection device. Various embodiments implement oral fluid collection, extraction, storage, and/or testing. The device can be used to collect fluid, and to then extract and prepare the fluid for analysis, which can eliminate human error in collection and reduce complexity in diagnostic analysis. The disclosed device may be used to collect any liquid specimen. Any instance when liquid should be collected, stored, and tested may benefit from use of this disclosure.
This application is a continuation application of U.S. Application No. 17/866,178 titled “Liquid Collection Device”, and filed Jul. 15, 2022, which claims the benefit of U.S. Application No. 17/459,508 titled “Liquid Collection Device,” filed Aug. 27, 2021 and issued as U.S. Pat. No. 11,419,587, which claims the benefit of U.S. Provisional Application Serial No. 63/071,870 titled “Oral Fluid Collection Extraction and Purification Device and Methods of the Same” and filed Aug. 28, 2020; U.S. Provisional Application Serial No. 63/089,409 titled “Oral Fluid Collection Device” and filed Oct. 8, 2020; and U.S. Provisional Application Serial No. 63/132,819 titled “Liquid Collection Device” and filed Dec. 31, 2020, the entire contents of which are hereby incorporated by reference.
FIELD OF THE DISCLOSUREAccording to certain embodiments of this disclosure, there is provided a liquid specimen collection device. Various embodiments implement oral fluid collection, extraction, storage, and/or testing. The device can be used to collect fluid, and to then extract and prepare the fluid for analysis, which can eliminate human error in collection and reduce complexity in diagnostic analysis. The disclosed device may be used to collect any liquid specimen. Any instance when liquid should be collected, stored, and tested may benefit from use of this disclosure.
BACKGROUNDOral fluid collection devices are widely used in the medical diagnostics industry for safe and convenient sample collection and disease identification. For examples, U.S. Pat. Nos. 9,198,641; 5,339,829; and 8,025,851 disclose devices that use a plunger, a collection pad, an adequacy indicator buffer, a compression seal, a filter, and a cartridge in various forms and combinations. There are also saliva collection systems manufactured by DNA Genotek, Ancestry, Oasis Diagnostics Corp., and Saliva Diagnostic Systems.
All the above disclosures focus on sufficiency and filtration of macro level particulates. In many applications, it is desirable to filter out specific molecular particulates such as proteins including mucins, amylases, albumin, etc. from the oral fluid. It is also desirable that some components are added to or extracted from the fluid sample prior to processing in a lab. Existing methods of collecting passive drool in a cup are prone to errors which can impact the efficacy of testing. Other methods of using an absorbent pad to collect the saliva does not provide sufficient filtration options, sufficient usability, or sufficient transport options for ease and use. Accordingly, the present disclosure addresses these needs.
SUMMARYThe present disclosure relates to a fluid sample collection device that can indicate sample sufficiency, filter specific proteins and cellular debris from the sample, add reagents to the collected sample, transport the sample to testing lab, receive a test strip to test the sample on site, or any combination thereof. The disclosed device can be used in applications ranging from human genomics, infectious disease testing, hormone testing, drug testing, microbiome testing, non-infectious disease testing, or any other appropriate test that can use a body fluid as a base sample. The disclosed device is particularly suited for collection of oral fluid such as saliva, but it should be understood that it may be used in connection with collecting and testing of other fluids as well. The disclosed device may be used to collect any liquid specimen, including but not limited to oral fluid/saliva, urine, blood, sweat, tears, or any other fluid. It may also be used to collect liquid from a stream or puddle for further testing. Any instance when liquid should be collected, stored, and tested may benefit from use of this disclosure.
It is generally envisioned that the collected fluid, which is described herein as being bodily fluid such as saliva, may be collected for various types of testing.
The device can purify samples during storage and transport to remove cells, mucins, and debris such that centrifuging steps or other chemical filtration steps such as solid phase extraction may not be required prior to analysis. The device can also extract nucleic acids from the sample such that nucleic acid extraction steps may not be required in a lab prior to analysis. These various types of testing include but are not limited to diagnostic testing, testing for infectious disease or other afflictions, genetic testing, hormone testing, endocrinology testing, drug testing, microbiome testing, non-infectious disease testing (for any type of health area such as cancer testing, cardiology testing, diabetes testing, or any other appropriate testing that can be done with bodily fluids) or any type of tests that may be run on collected fluid in order to identify an internal condition of a subject. It is also possible for the testing to include chemical testing, water chemistry analysis, chlorine testing, contaminant testing, or any other appropriate analysis that may be conducted on a liquid.
In one example, there is provided a fluid collection device, comprising: a collection pad; a device body; and a collection container, wherein the collection pad is secured to a first end of the device body and wherein the collection container is positioned at a second end of the device body.
In the above or any subsequent examples, the collection container may be integrally formed with the device body to provide a one-piece device.
In any of the above or any subsequent examples, the collection container may be removeably secured to the device body. For example, the collection container may be threadingly secured to the device body.
In any of the above or any subsequent examples, there is a nozzle positioned within the device body for directing collected fluid.
In any of the above or any subsequent examples, fluid collected via the collection pad is collected at a first end of the collection pad, travels through the collection pad, and exits at a second end of the collection pad, into the collection container.
In any of the above or any subsequent examples, there is provided a filter positioned to filter collected fluid. The filter may be fiber components, track-etched-membranes, sintered particles, or any combination thereof.
In any of the above or any subsequent examples, there may be provided a cap with a length configured to be positioned over and cover the collection pad.
In any of the above or any subsequent examples, there is a buffer, additive, or reagent incorporated into the fluid collection device. The buffer, additive, or reagent may be incorporated into the collection device via any of the following or any combination thereof: a cap that is positioned over the collection pad and when pressure is applied to the collection pad via the cap, the buffer additive, or reagent is released; a filter through which collected fluid travels on its way to the collection container; in the collection container; in a buffer pouch that releases buffer during use; in a separate buffer container; or in a separate buffer sponge.
In any of the above or any subsequent examples, there may further be a funnel positioned with respect to the device body.
In any of the above or any subsequent examples, the collection container may be a dropper bottle.
In any of the above or any subsequent examples, there may be provided one or more venting features. The one or more venting features may be a porous vent gasket, threads between the device body and the collection container, an exhaust vent, a plunger, or a vent tube with side openings on the device body.
In any of the above or any subsequent examples, there may be provided a sample sufficiency indicator.
In any of the above or any subsequent examples, there may be a moveable base.
In any of the above or any subsequent examples, a seal between the device body and the collection pad may be created by an adapter.
In any of the above or any subsequent examples, there may be provided an access point on the collection container configured to allow sample extraction from a collection container that remains integral with the device body or from a collection container that is removed from the device body.
In any of the above or any subsequent examples, there may be provided an oral fluid sample collection and testing device, comprising: a buffer solution contained within or associated with a buffer container; a collection pad for use in collecting a saliva sample from a patient; and a test strip; wherein the buffer solution and the saliva sample are contacted with one another and then contacted with the test strip.
In any of the above or any subsequent examples, the buffer solution may be provided in a buffer ampule or a buffer cup.
The terms invention,” “the invention,” “this invention” “the present invention,” “disclosure,” “the disclosure,” and “the present disclosure,” used in this patent are intended to refer broadly to all of the subject matter of this patent and the patent claims below. Statements containing these terms should be understood not to limit the subject matter described herein or to limit the meaning or scope of the patent claims below. Embodiments of the invention covered by this patent are defined by the claims below, not this summary. This summary is a high-level overview of various aspects of the invention and introduces some of the concepts that are further described in the Detailed Description section below. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used in isolation to determine the scope of the claimed subject matter. The subject matter should be understood by reference to appropriate portions of the entire specification of this patent, any or all drawings and each claim.
In one embodiment, the device incorporates a collection pad for collecting a liquid sample, a filter, and a collection container. The device may also incorporate a cap that is used to squeeze the liquid sample that is collected by the collection pad through the filter and into the collection container. Other embodiments do not use a filter, but include a collection pad and a device body that can hold the collected sample.
Referring now to
The device body 14 incorporates a collection pad 12 that is in fluid communication with the collection container 18. In a specific example, the collection pad 12 may be connected to one end of the device body 14 and the collection container 18 may be connected to the other end of the device body. Other connection options are possible, such as a direct connection or an indirect connection between the collection pad 12/device body 14 and/or the device body 14/collection container 18.
In the example illustrated by
In one example, the filter 20 may have an outer diameter (OD) that closely matches the inner diameter (ID) of the upper open end 22 such that it is press fit into place. It is also possible for the OD of the upper open end 22 to have external grooves that can receive the one or more O-rings 24 for a liquid tight seal with the cap 16.
In one example, a nozzle 15 may be provided inside the device body 14, extending the length between the collection pad 12 and the collection container 18. The nozzle 15 can be a hollow tube that helps facilitate movement of the saliva to the collection container 18, after passing through the filter 20. The nozzle 15 effectively reduces the size of the cavity 26 between the collection pad 12 and the collection container 18. It is a thin hollow tube positioned within the cavity that has a smaller diameter than the diameter of the device body. The nozzle 15 allows more of the collected fluid to pass into the collection container 18 rather than getting stuck on sides of the device body during sample collection or transfer. This can be particularly useful for collection of smaller amounts of fluid, such as saliva. The nozzle 15 also extends down into the collection container 18 in order to help prevent leakage and/or splashing of the collected fluid near/around the connection between the device body 14 and the collection container 18. For example, if this connection is a threaded connection, the presence of nozzle 15 helps ensure that the collected saliva stays away from the threads when the container is opened. The nozzle 15 provides a pathway between the pad and the collection container. The nozzle can be connected to and a part of the device body 14. In the example shown by
The collection container 18 is secured at a second end 28 of the device body 14. The collection container 18 may be secured to the device body 14 in any appropriate manner. A threaded fit has been found to be most effective. Threaded connections are illustrated by
A cap 16 is provided to cover and protect the collection pad 12 prior to use of the device 10. In use, the cap 16 is removed and fluid is collected. Once the fluid has been collected, the cap 16 is replaced over the collection pad 12, as shown in
When the collection pad 12 is compressed via the cap 16, fluid contained therein is released from the collection pad 12, passes through the optional filter 20 if provided, and into the collection container 18. Because compression of the collection pad 12 takes place in the closed environment of the device 10, it may be necessary to provide a venting option in order to achieve a good compression. Various venting options are described in more detail below.
After collection of the fluid from the collection pad 12 takes place and is delivered to collection container 18, the collection container 18 is preferably removable from the device body 14, such that the fluid can be transported elsewhere for subsequent testing/processing. A collection container cap 30 may be provided that can be secured to an upper open end 32 of the collection container 18 once it has been removed. The collection container cap 30 may be threadably secured to the upper open end 32, it may be a fliptop cap, or any other appropriate capping or sealing option. In alternate embodiments, the collection container 18 may be a squeeze tube 44, similar to an eye dropper, that is squeezed to transfer liquid to a testing assay, such as a rapid diagnostic test. Examples are shown by
Reference will now be made to specific features/options of the disclosed collection device 10.
Collection PadThe fluid that may be absorbed by collection pad 12 may be any appropriate fluid to be collected and/or tested. Non-limiting examples include but are not limited to oral fluid, saliva, urine, blood, diarrhea/feces, sweat, vaginal fluids, semen, or any other appropriate fluid. Although described in connection with healthcare, it should be understood that the disclosed device may be used for a myriad of other fluid collection uses. The collection pad may be associated with a sufficiency indicator that can change color or otherwise provide a visual indication that the collection pad is sufficiently wet with the fluid to be collected.
The collection pad is intended to absorb and hold liquid, but to also release the held liquid upon compression. The material of collection pad could comprise of fibers, foams or particulate materials made from polyesters, polyurethanes, polyethylene, polypropylene, PTFE, PVDF, elastomeric materials, thermoplastic polyurethane, thermoplastic polyethylene, nylon, cellulose, cellulose acetate, natural fibers, fabric, paper, polymer hydrogel (dry form and/or wet form) such as HEMA, NIPAM, etc., a natural or man-made material, sponge, cotton, or any combination thereof. The collection pad may be treated with dried buffer, saliva-production stimulants such as citrates, materials that prevent target analyte binding to the material, surfactants to help collect and release liquid, or any other appropriate material, or any combination thereof. It is also possible to provide a hollow collection pad, such that the collection pad is a tube that has a hollow tubular length.
CapA cap 16 may be provided that can protect the collection pad 12 during transport and that can be pressed against the collection pad in order to force collected liquid sample out of the pad 12 and into the collection container 18. In some instances, the collected liquid sample travels through a filter on its way into the collection container 18. In a specific example, the cap 16 is designed and positioned such that it covers the collection pad 12. Pressure or force against the cap 16 can consequently apply pressure or force against the collection pad 12. This can squeeze the collected liquid through the filter (if provided) and into the collection container 18. In another specific example, the cap can form a seal with the outside of the collection device to ensure all fluid is directed through the collection pad (and optional filter) and into the collection container, and prevent leaking of fluid to the outside of the device. For example, when the cap 16 is pressed, a seal between the O-rings 24 of the side of the device body 14 and the inner diameter of the cap 16 can create a liquid-tight seal.
In use, the cap 16 is pressed onto the device body 14 and pressure causes the liquid collected in the collection pad 12 to be transferred through the device body 14, through the nozzle 15 (if provided), through an optional filter 20, and into the collection container 18. O-rings 24 positioned around an upper portion of the device body 14 can help create a liquid tight seal when the cap 16 is pressed down. Pressure from compressed air that is pressed through the device body can be released through a vent option, various options of which are described below. In one example, the vent option may be threads between the device body 14 and the collection container 18. Additional solutions are described further below. There may also be a feature 17 on the inside of the cap that adds extra compression to extract the maximum amount of liquid from the collection pad. This may be an interior plunger, spikes inside the cap, or any other appropriate feature. When the cap 16 reaches the end of its completed travel, detent features can fit over the device body 14 and engage to ensure a completed lock and snap into place. Detent features may be positioned at the end/bottom of the cap flange 38 and can snap over the body flange 39 just above where the collection container 18 is secured to the device 10.
The cap 16 and lower flange 38 may also be provided with feedback features that allow a user to know that the cap has been secured to the device body 14. Feedback features also indicate that the cap 16 has reached its full travel distance and that the swab has been fully compressed, signaling that no further action is needed and that all collected fluid available to transfer has been transferred to the collection container. In one example, the feedback features are provided as a detent/protrusion system that gives a tactile click feeling. This may be provided by a small internal protrusion 86 on the cap 16 and a similarly-shaped detent 87 on the ledge 38, which is illustrated by
The filter 20 is generally positioned below (or downstream of) the collection pad 12 and functions to filter out unwanted media from the liquid collected. The filter 20 can filter out undesired particles or other contaminants in the collected sample. Providing a filter 20 can help eliminate later centrifuging steps that would otherwise be required during testing of the collected sample. Providing a filter 20 can help concentrate the sample. Providing a filter 20 can help provide sample homogenization. Bio junks such as mucin clusters can be eliminated or grinded by passing through the filter 20, thus reducing the sample viscosity and facilitating liquid handling.
Non-limiting examples of particles that may be filtered out of the sample include but are not limited to molecular particulates, cells, proteins, cellular debris, nucleic acids, mucins, glycoproteins, bacteria, viruses, large biomolecule clusters, large size bacterial particles, dust particles, fibers, other environment contaminates, or any combination thereof.
Non-limiting examples of materials that may comprise the filter include but are not limited to fiber components, track-etched-membranes, and sintered particles that can offer various porosities or void volume to the filter. Porex, the current assignee of this application, manufactures and holds patent protection on various filters and/or filtration systems that may be usable in connection with this disclosure. The filter may be used to mechanically and/or chemically filter out any of the above-described particles from the liquid sample. It is possible to incorporate reagents, additive, or buffers into the filter that can be mixed with the collected fluid as it passes through. Such reagents, additives, or buffers can be added in order stabilize the liquid sample/saliva or analytes and/or to allow more accurate detection and/or to provide for viral inactivation, viral lysis, to stop or prevent bacterial growth, or any other appropriate reason for use of reagents, additives, and/or buffers.
Collection ContainerThere is a tight seal made when the collection container 18 is screwed (or otherwise joined) onto the device body 14. The collection container 18 may be any type of container that can collect, hold, and/or transport a liquid sample. Embodiments include but are not limited to vials, centrifuge tubes, cryo vials, blood collection tubes, saliva collection tubes, syringes, dropper bottles with a lower dispenser tip or dropper that allows the sample to be squeezed out of the collection container once collected (and filtered, etc.), syringes, or any combination thereof.
The collection container 18 may be connected to the device body 14 in any appropriate manner. Non-limiting examples of various joining mechanisms include but are not limited to a threaded connection, a press fit connection, a cone-in-cone friction fit connection, a magnetic connection, side clip arms or fastener connection, or any other appropriate type of joining mechanism. (As described elsewhere herein, it should also be understood that the collection container may be made integral with the device body, such that the entire device is sent out for testing.)
In one embodiment illustrated by
Regardless of configuration, the collection container 18 may be pre-filled with reagents, additives, and/or buffers. These materials be provided in liquid or dry or lyophilized (freeze-dried) form. In a further embodiment, a buffer or other reagent or additional additive may be provided associated with the collection pad 12, anywhere within the liquid collection device 10, or provided in a separate pad or container designed to release the buffer or other reagent or additional additive. This material may be any fluid, buffer, preservative, viral inactivation liquid, or any other appropriate material that can be contacted with a collected sample and help with stabilization, preservation, safe transport, lab safety, clinical safety, or support or enhance further processing for diagnosis or testing. Examples are described further below.
FunnelIn order to collect an oral fluid sample, it may be possible for the user to put the collection pad 12 directly into his/her mouth. Alternatively, there may be provided a funnel 50 at a top portion of the device body 14 that allows a user to spit into the top of the device. It is also possible for the patient to be administered an oral rinse prior to delivering saliva, which can help generate saliva. Alternatively, it is possible for a different type of fluid to be poured into the funnel 50. As shown by
The collection pad 12 can absorb some of the fluid, but the remaining fluid remains in the funnel 50. The user can then position a top/cap 52 over or within the funnel 50 and press down to compress the collection pad 12 and/or to force the fluid through the collection pad 12 (and optional filter 20, if provided) into the collection container 18. It is possible to provide a visual indicator mark 58 on the side of the funnel 50 that can show how much fluid is needed (shown as a dotted line on the funnel, indicating the level of collected fluid requested, although other indicator options are possible.) This funnel 50 embodiment can potentially eliminate a step or other component in the collection process with oral rinse or greater amounts of fluid specimens to be collected. The funnel 50 can be designed to only transfer a specific amount of liquid into the device body 14 when it is compressed and hold the rest in the funnel.
In order to collect a different type of liquid sample, the collection pad 12 may be positioned in or near the liquid to be tested. For example, if river water is being tested, the collection pad 12 can be dipped in the water. If blood is being tested, the collection pad 12 can be dipped in the blood. If urine is being tested, the user may urinate on the collection pad 12 or in the funnel 50 embodiment, if provided.
Movable BottomOne example for venting is to provide a movable bottom or base 56 of either the collection container 18 or the device body 14 itself, collectively referred to below as a tubular body 60. In this embodiment, the tubular body 60 may have an upper opening 58 that receives the collected sample, and a moveable base 56 positioned within the tubular body 60. A lower opening 62 of the tubular body 60 is generally open, but may have an inward ledge 64 that functions as a moveable bottom stop. In one example, the movable base may be shaped like a syringe plunger end, but without a plunger shaft. An example is shown by
In use, the movable base 56 begins positioned close to the upper opening 58 of the tubular body 60. The movable base 56 starts at the top/upper opening 58 and moves down the tubular body 60 as the tubular body 60 is filled with sample. More specifically, as the collection pad 12 is compressed (which may be via a cap or plunger or any other compression member), the movable base 56 is caused to move lower into and through the tubular body 60 as the volume of the liquid sample is moved downward (along with air that cannot be compressed, thus the function of the movable base 56 as a venting feature). The moveable base 56 may maintain a seal with the side of the tubular body 60 in order to prevent air, gas, and/or liquid from moving between the top opening 58 and the lower opening 62. This venting feature maintains the collection device as a closed system.
Venting FeaturesBecause the liquid collection device 10 is generally a closed system, during movement of liquid sample from the collection pad 12 into the collection container 18, pressure may build up. Thus, various venting options may be provided. Any of the venting features described herein may be used individually or collectively in any of the described embodiments.
One example of a venting feature described briefly above is to provide a tortuous path through threads (or any other joining mechanism) that connect the collection pad 12 with the collection container 18 (albeit this connection is an indirect connection in most cases). These threads may be located at the bottom of the device body 14 where the collection container 18 is connected to the device body 14.
Another venting option is to provide an internal air plunger 68, as illustrated by
A further venting option illustrated by
A further embodiment of a side air vent tube 72 is illustrated by
A further venting option incorporates an exhaust filter 80. This is illustrated by
Another option is to provide a venting gasket/washer 82.
The structure of the vent gasket 82 may be a circular design with an internal opening that allows liquid to pass through the interior of the device body 14. One example is illustrated by
The vent gasket 82 may be made of sintered particles, fiber, foam, or track-etched-membrane. The sintered particles may be mixed with other particles, such as self-sealing particles. The sintered particles (or material combination) may be mixed with material that allows air to pass through but not liquid. One example of such a material is an IP68 rated material. Exemplary filter material that may be used for vent gasket 82 are manufactured and sold by the current assignee, Porex.
A sample sufficiency indicator may be provided. An exemplary sample sufficiency indicator 88 is illustrated by
Referring now to
In any of the embodiments described herein, the buffer solution may function as a cell and viral particle lysing agent, anti-bacterial, DNA stabilizer, antigen stabilizer, or any combination thereof. The buffer may also contain a chemical that extracts the DNA/RNA from any source (human, animal, bacteria or viruses) which can allow an extraction-free analysis in the lab. Various additional or alternative buffer, reagent, or additional additive options, as well as structures for containing these materials, are described below.
Pressure from the plunger results in squeezing the pad 12 against the buffer/reagent pouch/pad 98 (either directly or indirectly, via way of the filter 20, the cap 16, or any other pressure device). Pouch/pad 98 could also be designed to be punctured in use. Pouch/pad 98 could also be designed to dissolve when comes in contact with saliva or other collected fluid. It should be understood that there are also other methods of breaking the barrier of the pouch/pad 98 that result when the pouch/pad 98 is mechanically squeezed in use. Buffer/reagent is then released and mixed with the collected sample and passed into the collection container 18 connected at the end of the device. If provided as a buffer pad 98, the buffer pad can be made of fibers, foams or sintered particles with varying pore sizes (1 - 200 microns). The void volume may range from 20 to 99%. The fiber or sintered particles could be made from polyesters, polyurethanes, polyethylene, polypropylene, PTFE, PVDF and elastomeric materials such as thermoplastic polyurethane, and thermoplastic polyethylene or a combination thereof. The buffer pad may be treated to mechanically and/or chemically filter out particulates, protein molecules, or any other type of other debris, contaminants, or desired molecules from the oral fluid sample, such that an additional filter 20 is not required. The buffer pad may contain absorptive additives such as activated carbon, molecular sieves, polymeric absorptive resins, or any of the other additive described throughout this application. The filtrates may include the 5 mucins in saliva (MUC5B -5700AA, MUC7 -357AA, MUC1, MUC4, MUC19), bacterial cells, viral proteins, amylases, albumin, or any other appropriate filtrates, or any combination thereof.
In another example of
In these plunger embodiments, it is still desirable to be able to maintain the seal of the collection container 18 to the device body 14 in order to maintain the sample integrity within the collection container (e.g., not introduce outside air), but still be able to vent air through the collection device. Accordingly, any of the above described vent options are possible for incorporation with this embodiment as well.
Both
As described above, the collection container 18 at the end of the device body 14 may be detachable and can be used to ship the sample to a lab for analysis.
In another embodiment of
In another embodiment, the device may have a collection pad that is permanently attached to the device. The collection pad is exposed during sample collection and retracted once sufficient sample is collected. All other components are within the device along with the collection pad. This provides a one component system. Examples are illustrated by
Referring now to
The fluid collection device is provided in the configuration shown in
In use, the user opens the swab cap 178 and presses the plunger 180 into the body housing 176 in order to expose the collection pad 12. In some embodiments, the swab cap 178 may be provided with a series of openings and non-openings that are used to allow the collection pad 12 to pass through or push against. In this embodiment, the swab cap 176 always stays “on” the body housing and just rotates through the open and closed positions, much like a dial (similar to a rotary phone). In order to maintain the device as a single piece, the swab cap 178 may be attached to the body housing 176 via a living hinge 188. Once the collection pad has been extended and exposed as shown by
Once collection has taken place, the user retracts the plunger 180 in order to pull the collection pad 12 back into the body housing 176 and replaces the swab cap 178. The liquid collection device will then resemble
As the collection pad 12 is compressed, collected fluid exits the body housing 176 through the one-way valve 186. If a filter 20 is provided, the fluid also passes through the filter 20 on its way to the collection container 18.
Once the fluid has been collected in the collection container 18, it is possible to remove the collection container 18 for further analysis of the collected sample. The collection container 18 may be snap fit to the body housing 176 for easy removal thereof. In one example, the body housing 176 may be formed with an internal groove that receives the external curvature of the collection container 18, as shown by
In one example, the collection container 18 may have a septum to assist with lab analysis. In another example, there may be provided a buffer pouch 98 associated with the collection container 18, as shown by
Alternatively, the body may be twisted so that the pad retracts 12 into the body 176. This embodiment may incorporate additional buttons, knobs, handles to push/pull/twist, but not extra components to handle.
A reagent material or additional additive or buffer may be incorporated into the liquid collection device 10. The design of the disclosed device can allow for automatic mixing of the reagent/additional additive/buffer with the collected sample without any additional steps required by the user. The material can be provided pre-loaded with the device. Non-limiting exemplary options of how the material may be incorporated are provided.
This material may be on or within the filter 20, the collection pad 12, the cap 16, the collection container 18, in a mixing chamber, in a separate pouch, or provided as an additional component or as any part of the device in the fluid path between collection pad and the collection tube. In general, a reagent or additional additive may be provided or otherwise incorporated into one or more components of the liquid collection device in any way that allows or otherwise causes the reagent or additional additive to contact the collected liquid sample.
In a specific example, the buffer or other reagent or additive material may be a liquid contained in the cap 16 (within an absorbent pad or by itself) such that, when compressed with the collection pad 12, the material is released and flushes the collected sample through the collection pad 12 and into the collection container 18. (If an optional filter is provided, the sample may also pass through the filter during compression.) If a filter 20 is provided, the filter 20 may contain the same liquids or a powder versions of the material that can be reconstituted when saliva comes in contact with the material. In another example, the material may be provided in its own mixing chamber. Exemplary buffer or other reagent or additive materials are described further below.
The reagent or additional additive could be loose material, a liquid in a pouch, in a swab, in a membrane, in a foil seal that is pierced or broken for release, in a powder form that is reconstituted when the liquid sample passes by or through it, in a form of a pellet (formulated pill), as a capsule provided in the collection container or any part of the device, or any combination thereof.
In one example, a reagent or additional additive may be provided in the collection pad. In another example, the filter may be treated or at least partially coated with a reagent or additional additive. In another example, a reagent or additive may be stored behind a barrier that dissolves when it comes in contact with liquid. In another example, a reagent or additional additive may be stored in a cap, such that the reagent or additional additive is released when the cap applies pressure to the collection pad. For example, a reagent or additional additive may be provided in a swab positioned within the cap that can be dosed with the reagent/additional additive and released upon compression in order to mix with the collected sample. A reagent or additional additive may be provided in a foil seal that is broken/released upon pressure. In another example, a reagent or additional additive may be liquid, powder, a coating on an interior of any part of the collection container (e.g., its walls or base), or a loose liquid contained in the collection container, or any other appropriate component that can contact the liquid sample while it is contained within the liquid collection device. Any combination of the above options may be incorporated with one another.
Non-limiting examples of reagents/additional additives include but are not limited to a buffer (dried or in solution), a preservative, a cell or a viral particle lysing agent, a viral inactivation agent, a chemical inactivator that can inactivate infectious particles but leave them intact for later testing, a bacterial static solution that does not kill bacteria but prevents further bacteria growth, a particle stabilizer (e.g., a DNA stabilizer or antigen stabilizer), an antibacterial, cortisol, progesterone, a viral transport media (VTM), dye, organic solvent (to precipitate/isolate the DNA/RNA), reagent required by assay, beads for grinding, beads with antibody/antibodies, flavorings, stimulants to induce saliva production, chemicals that can create an isothermal reaction to raise or lower the temperature of the solution (for controlling bacterial or viral growth, inactivation, transportation stabilization, or even to induce molecular diagnostic reactions such as LAMP - oop-mediated isothermal amplification), a reagent or additive that can react with collected sample and provide a diagnostic result shown as color changed liquid in the final collection container or collection window, or any combination thereof.
More specifically, the reagent or additional additive may be an inactivation buffer. One example is a lysis buffer. Exemplary compositions of possible buffers are outlined in the below table:
Possible buffers will typically include one or more of the following components, either alone or in various combinations: tri-n-Butyl phosphate; Tween® 80 (Polysorbate); Triton® X-100; Sodium laureth sulphate; Benzalkonium chloride; Chlorhexidine; Chlorhexidine with CphC; CPyC; Ag nanoparticles suspension; Polymers; polyethylenimine (PEI) disrupt lipid envelope; β-cyclodextrins (βCDs); Proteinases; protease K; Brij-97; LDAO; QACs; LAS; or any combination thereof.
One general goal of the reagent or additional additive is to allow release of analytes from the collection pad for later testing. Another general goal of the reagent or additive is to preserve the sample for later analysis, or to enhance the overall safety or efficacy of the collection system.
Additional FeaturesThe device can be designed to ensure ease of transfer for high throughput lab processing using automated equipment. For example, the collection container could have a cap that allows for direct connection to automation equipment to remove samples in the lab or at the point of care. The device could have a sample extraction port so the user sends the whole device to the lab (once sample collection is complete) and the lab can just drop the device into the automation equipment. The device can have QR codes with sample information and can allow results be scanned into a database through an app to issue a certificate of testing.
Automation/TestingIt is possible to design a custom rack 210 that is designed to fit one or more embodiments of the disclosed fluid collection device 10, 200, its tubular body 60, 112, 176, or any other component. The device can be designed to allow the liquid handling robot to directly pull the collected sample out of the device without having to remove the cap 16. A user can insert the device into the rack 210, and the liquid handling machine can remove the collected sample through an access point of the collection container. In a specific example, the access point is a port 206 in the collection container 18. The port 206 can be designed to receive a pipette top 204. (This port 206 could be a needleless port, could incorporate a port valve, could be an access point covered by a foil (or other accessible) seal, or any other appropriate access point/port option.) The nozzle 15 and gasket (shown immediately below the nozzle 15 in
The device may be provided with a unique bar-code identifier on a label placed on each device or on the collection container that is later disconnected and sent to the lab for further processing. This unique identifier can be used to help trace the device and link test results in a system to an individual. This linking may be done via a mobile app. The device may include a QR code that can automatically download and install an app prior to testing. The app can automatically include information on the unique identifier.
The developing company can generate and maintain a database of test results. It is also possible to integrate the identifier with apps and databases created by other assay developers. During testing, the unique identifier can be automatically scanned into the system using the bar code. Test results that are generated can be automatically linked to this identifier. The app can then connect to the database of test results, and read and display the results along with a time stamp. This can allow test results to be displayed to the end user. In some public disease situations or outbreaks, the database/app can also generate a “passport” to allow easy access to public venues. In a specific example, if the test of the sample is conducted to determine whether a tested subject has COVID or some other virus or affliction, the testing can be relayed to the patient to allow the patient to show that s/he is “cleared/free of virus antibodies” in order to board a flight, gain access to a public gathering, show family members and friends that they are clear, or any other purpose.
Incorporated Test StripThe next set of figures provides embodiments that incorporate devices that function to collect an oral fluid sample from a patient, mix that sample with a buffer, and then contact the mixed sample/buffer with a test strip. Various options for the device are described herein. It should be understood that these are provided as examples only and that any of these plunger/test strip embodiments may be modified for use in connection with the above described device 10 of
In the embodiment illustrated by
A further embodiment provides a buffer solution inside a glass (or breakable) ampule. One example is illustrated by
Another embodiment elaborates further on the various buffer options described above. In this version, if the buffer container 110 and the tubular body 112 are provided in transparent plastic or other see-through material, it is possible for the plunger itself to act as a sample sufficiency indicator. For example, when the collection pad 12 is moistened, it may become translucent, indicating that it has collected enough fluid. In another embodiment, the collection pad 12 could be designed to change colors when contacted with fluid. In further embodiment, there may be provided a foam component between the plunger and the swab. If the foam becomes moistened, it can change color based on a pH reaction, a thermochromatic reaction, or other aqueous reaction, indicating sufficient sample has been collected/received by device.
In another example shown by
In a further example, the collection pad 12 may be held or otherwise supported by a barb 134 that extends from the plunger. One example is illustrated by
In a further example, the filter itself is a filter barb 138. Other shapes are possible and considered within the scope of this disclosure. The general concept that the filter itself can create a mechanical lock with the collection pad 12. One example is illustrated by
A further embodiment shown by
Any combination of any of the above described features of any components of the disclosed liquid collection device may be interchanged with one another as possible and considered within the scope of this disclosure.
The subject matter of certain embodiments of this disclosure is described with specificity to meet statutory requirements, but this description is not necessarily intended to limit the scope of the claims. The claimed subject matter may be embodied in other ways, may include different elements or steps, and may be used in conjunction with other existing or future technologies. This description should not be interpreted as implying any particular order or arrangement among or between various steps or elements except when the order of individual steps or arrangement of elements is explicitly described.
It should be understood that different arrangements of the components depicted in the drawings or described above, as well as components and steps not shown or described are possible. Similarly, some features and sub-combinations are useful and may be employed without reference to other features and sub-combinations. Embodiments of the invention have been described for illustrative and not restrictive purposes, and alternative embodiments will become apparent to readers of this patent. Accordingly, the present invention is not limited to the embodiments described above or depicted in the drawings, and various embodiments and modifications may be made without departing from the scope of the claims below.
Claims
1. A device for collecting a liquid sample, the device comprising:
- a. a collector configured to collect a liquid sample;
- b. a container in fluid communication with the collector and configured to receive the liquid sample from the collector in a condition in which the collector and container define a closed environment; and
- c. a vent configured to release pressure from compressed air in the closed environment.
2. The device of claim 1, wherein the vent comprises a vent gasket positioned at a connection between the collector and the container.
3. The device of claim 2, wherein the connection between the collector and the container comprises a threaded connection, and wherein the vent comprises the vent gasket and the threaded connection.
4. The device of claim 3, wherein the threaded connection comprises a tortuous venting pathway.
5. The device of claim 1, wherein the vent comprises a movable body in combination with a vent opening.
6. The device of claim 5, wherein the device is configured such that the movable body moves in response to the container receiving the liquid sample.
7. The device of claim 6, wherein the collector comprises a liquid sample passageway including a distal end where the liquid sample is dispensed into the container, wherein the movable body is located between the distal end and the vent opening.
8. The device of claim 7, wherein the device is configured such that the movable body moves away from the distal end of the liquid sample passageway and towards the vent opening as the liquid sample is dispensed into the container.
9. The device of claim 6, wherein the movable body comprises a movable bottom of a collection chamber in the container.
10. The device of claim 6, wherein the collector comprises a collector body, wherein the movable body is located inside the collector body, wherein the vent opening is a hole in the collector body.
11. The device of claim 10, wherein the collector body comprises a liquid sample passageway in an interior of the collector body, wherein the liquid sample passageway extends through the movable body, wherein the movable body seals against the liquid sample passageway and an interior wall of the collector body.
12. The device of claim 1, wherein the vent extends through a wall of the collector, wherein the device is configured such that air is forced from the container, into the collector, and out of the vent as the container receives the liquid sample from the collector.
13. The device of claim 12, wherein the collector further comprises an exhaust filter configured to allow air to pass through the filter and configured to prevent liquid from passing through the filter, wherein the device is configured such that air is forced from the container, into the collector, through the filter, and out of the vent as the container receives the liquid sample from the collector.
14. The device of claim 1, wherein the vent comprises a tortuous venting pathway.
15. The device of claim 1, wherein the collector comprises a vent tube that extends into the container.
16. The device of claim 15, wherein the device is configured such that air is forced from the container, into the vent tube, and out of a vent opening of the collector as the container receives the liquid sample from the collector.
17. The device of claim 15, wherein the vent tube and the container are configured so that the liquid sample received in the container cannot enter the vent tube when the device is moved through a plurality of orientations.
18. The device of claim 15, wherein a distal end of the vent tube is located proximate a central portion of the container so that the liquid sample received in the container cannot enter the vent tube when the device is moved through a plurality of orientations.
19. The device of claim 1, wherein the collector comprises a liquid sample passageway including a distal end where the liquid sample is dispensed into the container, wherein the distal end of the liquid sample passageway is centrally located in an interior space of the container.
20. A device for collecting a liquid sample, the device comprising:
- a. a collector configured to collect a liquid sample;
- b. a container in fluid communication with the collector and configured to receive the liquid sample from the collector in a condition in which the collector and container define a closed environment;
- c. wherein the device further comprises at least one of a reagent, additive, or buffer, and wherein the device is configured such that the collected liquid sample is retained in the container in combination with the reagent, additive, or buffer; and
- d. a one way valve configured to prevent back flow of at least one of the liquid sample and the reagent, additive, or buffer.
21. The device of claim 20, wherein the collector comprises a liquid sample passageway for directing the collected liquid sample into the container, wherein the one way valve is located in the liquid sample passageway.
Type: Application
Filed: May 31, 2023
Publication Date: Oct 12, 2023
Inventors: Avi Robbins (Atlanta, GA), Robert Carpio (Suwanee, GA), Yuan Chang (Atlanta, GA), Kathleen Fitzpatrick (Blacksburg, VA), Rahul Maharsia (Peachtree City, GA), Saman Mahdavi Shahidani (Decatur, GA), Hayden Shelly (Atlanta, GA), Micah Streiff (Decatur, GA)
Application Number: 18/203,770