Patent Application
20230074519
Not applicable.
Filter paper (e.g., Whatman #903 paper) is used to collect blood samples to detect contaminants in the blood (e.g., heavy metals). However, current sample collection methods can negatively impact safety of personnel conducting the procedure, can negatively impact accuracy of testing of contaminants, and can decrease the speed of the testing process. Thus, it would be desirable to have improved systems and methods for biological sample collection.
Some embodiments of the disclosure provide a container for collecting a sample. The container can include a housing, an enclosure that is configured be pivotally coupled to and slidably engaged with the housing, and a sample holder slidably engaged with and received within the enclosure. The sample holder can include a substrate configured to receive the sample. The container in a first configuration can include the enclosure being engaged with the housing to enclose and seal the substrate within an interior volume of the container. The container in a second configuration can include the enclosure exposing the substrate to the ambient environment.
The foregoing and other aspects and advantages of the present disclosure will appear from the following description. In the description, reference is made to the accompanying drawings that form a part hereof, and in which there is shown by way of illustration one or more exemplary versions. These versions do not necessarily represent the full scope of the disclosure.
The following drawings are provided to help illustrate various features of non-limiting examples of the disclosure, and are not intended to limit the scope of the disclosure or exclude alternative implementations.
Filter paper is an established substrate for the collection and preservation of samples, including whole blood. Typically, the sample after being collected on the filter paper is allowed to dry in the ambient environment to preserve the sample on the paper. In this way, quantification of the amount of blood and thus concentration of contaminants in the blood can be more accurate when dried as it is associated with a surface area on the filter paper. In other words, if blood does not completely dry on the filter paper, the amount of blood analyzed is artificially high due to remaining water and thus the calculated concentration of contaminates would be lower than the actual concentration. In addition, allowing blood to completely dry mitigates pathogen exposure to laboratory personal as there is a significantly lower risk from pathogen transmission from being exposed to dried blood as opposed to liquid blood. Once the blood sample is dried and preserved on the filter paper, the dried samples can be shipped and stored prior to laboratory analysis.
In some cases, it can take up to two or more hours to adequately dry the blood sample on the filter paper, which involves exposing the filter paper to the ambient environment during drying. However, exposing the filter paper to the ambient environment can increase the risk of biohazard exposure (e.g., pathogen exposure) to personnel interacting with the filter paper, and can lead to sample contamination (e.g., external contaminates contacting the filter paper). For example, particulates floating in the ambient environment can be lodged onto the filter paper or the sample, which can disrupt proper accurate sample analysis.
Some embodiments of the disclosure provide advantages to these issues (and others) by providing improved systems and methods for biological sample collection. For example, some embodiments of the disclosure provide a biological sample container that can contain a substrate having a biological sample thereon, and can seal the substrate from the ambient environment while the biological sample dries. In this way, the sample container can protect the filter paper from contamination before collection, and the sample after collection. In some configurations, the sample container can include a built-in desiccant, which can facilitate drying of the biological sample by absorbing water vapor inside the container when the substrate is sealed from the ambient environment. In this way, the biological sample is not required to be exposed to the ambient environment to dry the sample (e.g., for two hours), which can expose the sample to contamination, and can limit the ability to collect samples. For example, by drying the biological sample while sealed from the ambient environment facilitates faster and more efficient sample collection (e.g., because the samples do not have to be left out for at least two hours, which may prevent sample collection in some areas, including those in which the humidity is too high in the ambient environment).
In some embodiments, the sample container can be easy to hold in a practitioner's hand (e.g., is ergonomic), regardless of the configuration of the sample container (e.g., whether the sample container is enclosed, open, etc.). In some cases, the sample container can include a housing, an enclosure pivotally coupled to the housing, and a sample holder received within the enclosure. The housing can be pivoted about the enclosure to move the housing past the substrate thereby freeing the substrate from being situated within the housing. In this way, the substrate can be placed into contact with a sample without requiring the practitioner to grasp the substrate. Thus, the practitioner can simply continue holding the housing, which can be more rigid than the substrate (e.g., a filter paper), to bring the substrate into contact with the sample. This can facilitate sample collection as typical systems are difficult to hold, contain flaps that interfere with sample collection, or require the practitioner to remove the substrate and bring the flimsy substrate into contact with the sample, each of which can interfere with proper sample collection (e.g., introducing smearing, blotting, etc., of the sample on the substrate that can interfere with proper blood quantification).
In some embodiments, the sample container can be used for collecting biological samples, or other samples that are not necessarily biological (e.g., but may include biological components). For example, the sample container can be used for biological samples including blood from humans (e.g., in a community, in a hospital-based setting, in research and health screenings, in self-collection at home, etc.), blood from animals (e.g., in veterinary applications, in farm applications including those for farm animals, etc.), other biological fluids including saliva, urine, breastmilk, etc. As another example, the sample container can be used for other samples (e.g., that are not necessarily biological in nature) including water from water sources (e.g., in environmental sampling, household water quality testing, well water testing, etc.).
In some embodiments, the sample container can include a substrate that is a filter paper. Filter paper has been routinely used to collect capillary blood for more than 60 years as part of hospital-based neonatal metabolic screening programs. It is also now used for a wide range of clinical, research, and direct-to-consumer testing purposes, primarily focusing on blood. However, as assay (and other) technology improves, it is becoming possible to quantify more and more markers in smaller and smaller volumes of blood. In addition, other bodily fluids including saliva, urine, and breastmilk can be tested. In these cases, the use of filter paper reduces the cost of sample collection, and increases convenience in transporting and shipping dried samples. For example, dried samples are more stable than liquid samples, dried samples take up less space and are easier to ship than liquid samples, and dried samples are not subject to the same level of biohazard regulation (e.g., due to less issues with transmissibility of blood borne pathogens). The sample container described herein can utilize filter paper (e.g., to take advantage of the benefits of a filter paper-based sample collection processes and systems), while overcoming the disadvantages associated with current dried blood collection systems.
In some embodiments, the housing 102 can include legs 118, 120, 122, 124, 126, 128, 130, 132 that extend away from the housing 102. For example, the legs 118, 120, 122, 124 are integrally formed with (or are coupled to) a top side of the housing 102, while the legs 126, 128, 130, 132 are integrally formed with (or are coupled to) a bottom side of the housing 102 (e.g., opposite the top side of the housing). As shown in
In some embodiments, the container 100 can include a chamber 134. The housing 102 can include a first end 136 opposite a second end 138 of the housing. The chamber 134 can be coupled to and in engagement with the housing 102. For example, the chamber 134 can be engaged with the housing 102 at the first end 136 of the housing 102.
In some configurations, the housing 102 can be pivotally coupled to the enclosure 104 (or vice versa). In this way, the housing 102 can rotate about the enclosure 104, or the enclosure 104 can rotate about the housing 102. In some cases, the housing 102 (or the enclosure 104) can rotate only after the enclosure 104 slides to extend a predetermined distance from the housing 102. For example, each protrusion 142, 144 can include a cylinder coupled to or internally formed with the respective protrusion (e.g., at an end, or other portion of the respective protrusion) proximate to the second end 138 of the housing 102. Correspondingly, each channel 146, 148 can include a cylindrical bore in fluid communication with the respective channel 146. In some cases, each bore can be directed into an end of each channel 146, 148 proximate the end of the enclosure 104 that includes the opening that defines the cavity 112. Regardless, each cylinder of each protrusion 142, 144 can engage with a respective cylindrical bore of a respective channel 146, 148 so that housing 102 can rotate about the enclosure 104 (or vice versa). For example, as the enclosure 104 is slid along the housing 102, each cylinder of each protrusion 142, 144 slides along a respective channel until each cylinder engages (e.g., snaps into engagement) with a respective cylindrical bore of the respective channel. At this point, the housing 102 can rotate about the cylindrical bores, but is blocked from sliding. However, once the housing 102 (or the enclosure 104) is rotated substantially (i.e., deviating by less than 10% from) 180 degrees, 360 degrees, etc., forcing of the enclosure 104 in a direction towards the first side 136 of the housing 102 removes the cylinders from each cylindrical bore and forces the protrusions 142, 144 into engagement with the respective channel 146, 148 thereby sliding the enclosure 104 towards the first side 136 of the housing 102, while blocking rotation of the enclosure 104 about the housing 102 (and vice versa).
In some embodiments, when the enclosure 104 is configured to slide relative to the housing 102, the enclosure 104 is blocked from rotating about the housing 102. Similarly, when the enclosure is configured to rotate relative to the housing 102, the enclosure 104 is blocked from sliding along the housing 102. In some configurations, the protrusions 142, 144 can extend substantially linearly along a length of the housing 102 (e.g., defined from the first end 136 to the second 138 of the housing 102), and the channels 146, 148 can extend substantially linearly along a length of the enclosure 104. In this way, the enclosure 104 slides in a straight manner along the housing 102.
In some embodiments, while the housing 102 has been described as including protrusions 142, 144 (and cylinders) and the enclosure 104 has been described as including channels 146, 148 (and cylindrical bores), any protrusion can be replaced with a corresponding slot (and vice versa) as appropriate. In addition, each cylinder can be replaced with each cylindrical bore (and vice versa) as appropriate. As an example, the enclosure 104 can include the protrusions 142, 144 (and the cylinders), while the housing 102 can include the channels 146, 148 (and the cylindrical bores).
The enclosure 104 can have a cavity 112, which can include a sample positioned therein. The sample holder 106 can be coaxially received within the cavity 112 of the enclosure 104, and can be slideably engaged within the cavity 112. For example, the sample holder 106 can be slid out of the cavity 112 as the enclosure 104 is slid along the housing 102. Thus, in some cases, the length of the cavity 112 can be longer than the length of the sample holder 106. In some embodiments, the sample holder 106 can include a body 150, an extension 152 coupled to the body 150, a gasket 154, and a substrate 156. As shown in
In some configurations, the substrate 156 can be planar, and can be formed out of different materials. For example, the substrate 156 can be filter paper. Regardless of the configuration, the substrate 156 can be configured to wick away and absorb a liquid (e.g., a bodily fluid, such as blood). In some cases, the substrate 156 can include indicia, which can include, for example, a barcode, a data matrix, an identifier, a serial number, a shape (e.g., a circle), etc.
In some cases, the chamber 134 can be removably coupled with the housing 102. For example, the chamber 134 can be removed and replaced. In one non-limiting example, the container 100 can include a desiccant 140 that is contained within chamber 134. Thus, after a period of time during which the desiccant has absorbed water vapor or liquid from the sample, the desiccant 140 can be replaced. The chamber 134 can be decoupled from the housing 102, the used desiccant 140 removed, the new desiccant 140 inserted, and the chamber 134 coupled to the housing 102.
Regardless of the configuration, the chamber 134 can define an interior space that can be in fluid communication with the interior volume 110 of the enclosure 104 when the container 100 is in the first configuration (e.g., the enclosure 104 is in a first configuration in which the enclosure 104 contacts the housing 102). In this way, the sample can be in fluid communication with the desiccant 140 while the container 100 is sealed from the ambient environment as shown in
As shown in
In some embodiments, the sample holder 106 can be pivotally coupled to the housing 102. In this way, as the enclosure 104 is slid along the housing 102 (or vice versa), the sample holder 106 maintains a consistent position (e.g., relative to the housing 102) so that the sample holder 106 (and the substrate 156) can be advanced into (or out of) the cavity 112. In other words, by the sample holder 106 being pivotally coupled to the housing 102, the sample holder 106 is blocked from sliding along with the enclosure 104 (or the housing 102). In some configurations, the housing 102 can include pins that are received within respective bores of the enclosure 104, while in other configurations, the housing 102 can have bores that receive respective pins of the enclosure 104.
In some embodiments, the chamber 134 rather than being removably coupled from the housing 102 can form part of the housing 102. For example, one or more walls of the housing 102 can define the chamber 134. In this case, then, the clip that retains the desiccant 140 can be coupled to the housing 102 (e.g., at a wall of the housing 102).
In some embodiments, the container 100 can move between the four different configurations, as appropriate. For example, the container 100 can move in the reverse order from the fourth configuration, to the third configuration, to the second configuration, and back to the first configuration.
In operation, the container 100 can move from the first configuration as shown in
Once the substrate 156 has received the sample, the enclosure 104 can slide along the channels 146, 148 to cover the substrate. Alternatively, the enclosure 104 can pivot 180 degrees relative to the housing 102 such that the substrate 156 is in position between the opposing walls of the housing 102. In this configuration, the substrate 156 is partially protected from contamination or physical contacts. The enclosure 104 can slide along the channels 146, 148 to return to the first configuration. In this configuration, the substrate 156 is enclosed. The peripheral edge 114 makes a sealing contact with peripheral edge 116 such that the liquids from the environment are prevented from contacting the substrate 156 within cavity 112. When the container 100 is in the first configuration, the sample on the substrate 156 is protected from contamination.
In another non-limiting example, the sample on the substrate 156 can be analyzed while held by the sample holder 106 in the container 100 in the third configuration or by removing the substrate from the container 100.
In yet another non-limiting example, a portion of the substrate can be cut, excised, punched out, or otherwise removed for analysis, while the remainder of the substrate 156 with the sample thereon is stored within the container 100 or elsewhere as a reserve sample. After the portion of the substrate is removed for analysis, the reserved portion of the substrate and reserved sample thereon may be protected from contamination by returning the container 100 to the first configuration.
In some embodiments, the sample may be analyzed by eluting one or more components of the sample from the substrate or removed portion of the substrate 156, and detecting for the one or more the analytes of interest in the eluent. Any appropriate form of analysis can be used (e.g., destructive methods, spectroscopic) to detect analytes of interest in the sample as eluted from the substrate or alternatively the substrate can be analyzed directly. The examples given are not meant to be limiting.
If a desiccant 140 is included in the chamber 134, the sample can dry while held inside the container 100. If numerous samples are collected, the containers 100 can be stacked to improve the user experience by saving space. Because the container 100 can be stacked with another of container 100, the user is provided with a means of organizing the container 100. By way of non-limiting example, the containers can be stacked according to subject, chronology, type of sample, location the sample was collected, or any other criteria as designated by the practitioner.
Some embodiments of the disclosure can provide a self-contained collection device that protects filter paper from contamination before and after collection. In some embodiments, a desiccant can be built into the device can protect the sample and can facilitate transportation of the sample immediately after collection, with no waiting time for drying (e.g., because the sample can dry while being enclosed by the device). In some cases, different types of filter paper can be inserted into the device, which can increase flexibility for different applications. In some configurations, the device can be easily held, which can enhance control during sample collection thereby increasing the quality of the sample collected. In some cases, the device can include an attachment point for the filter paper, so the filter paper can be easily installed and removed. In some configurations, the device can include a clip that holds onto a desiccant cartridge, which can be easily replaced.
Some embodiments of the disclosure overcome the limitations of previous devices that make it more difficult to apply samples to filter paper. In addition, the embodiments disclosed herein can be designed for flexibility in application, and can be used to collect capillary whole blood, saliva, urine, breastmilk, etc. Thus, human, veterinary, and other applications are possible. The device can also be used for environmental sampling to facilitate, for example, testing of domestic water sources for contamination with lead. In some applications, drying of the sample can advantageously be completed while the sample remains protected during transport and storage (e.g., which can facilitate faster sample collection).
The present disclosure has described one or more preferred embodiments, and it should be appreciated that many equivalents, alternatives, variations, and modifications, aside from those expressly stated, are possible and within the scope of the invention.
It is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless specified or limited otherwise, the terms “mounted,” “connected,” “supported,” and “coupled” and variations thereof are used broadly and encompass both direct and indirect mountings, connections, supports, and couplings. Further, “connected” and “coupled” are not restricted to physical or mechanical connections or couplings.
As used herein, unless otherwise limited or defined, discussion of particular directions is provided by example only, with regard to particular embodiments or relevant illustrations. For example, discussion of “top,” “front,” or “back” features is generally intended as a description only of the orientation of such features relative to a reference frame of a particular example or illustration. Correspondingly, for example, a “top” feature may sometimes be disposed below a “bottom” feature (and so on), in some arrangements or embodiments. Further, references to particular rotational or other movements (e.g., counterclockwise rotation) is generally intended as a description only of movement relative a reference frame of a particular example of illustration.
In some implementations, devices or systems disclosed herein can be utilized or installed using methods embodying aspects of the disclosure. Correspondingly, description herein of particular features, capabilities, or intended purposes of a device or system is generally intended to inherently include disclosure of a method of using such features for the intended purposes, a method of implementing such capabilities, and a method of installing disclosed (or otherwise known) components to support these purposes or capabilities. Similarly, unless otherwise indicated or limited, discussion herein of any method of manufacturing or using a particular device or system, including installing the device or system, is intended to inherently include disclosure, as embodiments of the disclosure, of the utilized features and implemented capabilities of such device or system.
As used herein, unless otherwise defined or limited, ordinal numbers are used herein for convenience of reference based generally on the order in which particular components are presented for the relevant part of the disclosure. In this regard, for example, designations such as “first,” “second,” etc., generally indicate only the order in which the relevant component is introduced for discussion and generally do not indicate or require a particular spatial arrangement, functional or structural primacy or order.
As used herein, unless otherwise defined or limited, directional terms are used for convenience of reference for discussion of particular figures or examples. For example, references to downward (or other) directions or top (or other) positions may be used to discuss aspects of a particular example or figure, but do not necessarily require similar orientation or geometry in all installations or configurations.
This discussion is presented to enable a person skilled in the art to make and use embodiments of the disclosure. Various modifications to the illustrated examples will be readily apparent to those skilled in the art, and the generic principles herein can be applied to other examples and applications without departing from the principles disclosed herein. Thus, embodiments of the disclosure are not intended to be limited to embodiments shown, but are to be accorded the widest scope consistent with the principles and features disclosed herein and the claims below. The following detailed description is to be read with reference to the figures, in which like elements in different figures have like reference numerals. The figures, which are not necessarily to scale, depict selected examples and are not intended to limit the scope of the disclosure. Skilled artisans will recognize the examples provided herein have many useful alternatives and fall within the scope of the disclosure.
Various features and advantages of the disclosure are set forth in the following claims.
This application claims priority to U.S. Provisional Patent Application No. 63/237,910, filed Aug. 27, 2021, which is incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63237910 | Aug 2021 | US |
