Sample collection device

Abstract

A device, system, and method for collecting samples for medical testing. The sample collection device includes a collection chamber coupled to a main body. The collection chamber extends from a first collection chamber end to a second collection chamber end. The collection chamber includes an opening adjacent to the second collection chamber end. The opening is configured to receive a first volume of biological sample. A projection extends into the collection chamber. The collection chamber is configured to translate between a first position and a second position relative to the projection, and the translation of the collection chamber from the first position to the second position causes a second volume of biological sample to be released from the collection chamber through the opening.

Description

Technical Field

[0004] , ,

[0001] Cross - Reference to Related Applications This application claims the benefit and priority of U.S. Patent Provisional Application No. 63 / 470,267, filed on June 1, 2023, the entire disclosure of which is incorporated herein by reference.

[0002] This technology generally relates to systems and methods for collecting samples for testing.

Background Art

[0003] Sample collection devices can be configured to collect cells and other biological materials, including, for example, those from urine, blood, plasma, saliva, etc.

Summary of the Invention

Means for Solving the Problems

[0004] A set of embodiments relates to a sample collection device for collecting a biological sample for analysis in a detection system. The sample collection device includes a body portion that extends along a body axis from a first body end to a second body end. The sample collection device includes a collection chamber coupled to the body portion and extending from a first collection chamber end to a second collection chamber end. The collection chamber includes an opening proximate to the second collection chamber end. The opening is configured to receive a biological sample. The sample collection device includes a wick positioned within the collection chamber. The wick is configured to receive the biological sample from the opening and store a first volume of the biological sample. The sample collection device includes a plunger extending from the body portion proximate to the second body end such that a portion of the plunger is positioned within the collection chamber. The collection chamber is configured to translate relative to the plunger along the body axis between a first position and a second position. By translating the collection chamber from the first position to the second position, a second volume of the biological sample is released from the wick and dispensed from the opening within the collection chamber.

[0005] In various embodiments, the first volume is larger than the second volume. The main body portion may include a shoulder adjacent to the second end of the main body, which prevents the collection chamber from translating beyond the second position. The collection chamber may include a vent adjacent to the first end of the collection chamber, the opening being in fluid communication with the vent while the collection chamber is in the first position, and the opening being sealed from the vent while the collection chamber is in the second position. The plunger may include a sealing member adjacent to the end of the plunger, the sealing member including an overmolded portion. The sample collection device may include a shroud coupled to the main body portion such that the shroud encloses at least a portion of the plunger. The shroud may include a projection configured to interface with the collection chamber to prevent the collection chamber from translating beyond the first position. The vent may be one of a plurality of vents equally spaced around the outer diameter of the collection chamber. The opening may be one of a plurality of openings equally spaced around the second end of the collection chamber. The sample collection device may include a shroud coupled to a portion of the main body adjacent to a second end of the main body, the shroud configured to receive a portion of the collection chamber and fix the collection chamber in the second position. The collection chamber may include a transparent portion, thereby making the wick visible through the transparent portion. The wick may be configured so that a visual indicator becomes visible when the wick receives a biological sample and the wick becomes saturated.

[0006] Another set of embodiments relates to a system. The system includes a cartridge device including a cartridge opening. The system includes a sample collection device configured to collect a biological sample for analysis and discharge the biological sample into the cartridge opening. The sample collection device includes a body portion extending along the body axis from a first body end to a second body end, and a collection chamber configured to be inserted into the cartridge opening and coupled to the body portion, extending from a first collection chamber end to a second collection chamber end. The collection chamber includes an opening adjacent to the second collection chamber end, the opening configured to receive a biological sample. The body portion includes a wick positioned within the collection chamber, the wick configured to receive a biological sample from the opening and to store a first volume of the biological sample. The body further includes a plunger extending adjacent to the second body end from the body portion, such that a portion of the plunger is positioned within the collection chamber. The collection chamber is configured to translate between a first and second position along the body axis relative to the plunger in response to an axial force applied to the body while the collection chamber is positioned within the cartridge opening. As the collection chamber translates from the first to the second position, a second volume of biological sample is released from the wick and distributed into the cartridge opening.

[0007] In various embodiments, the first volume is larger than the second volume. The main body portion may include a shoulder adjacent to the second end of the main body, which prevents the collection chamber from translating beyond the second position. The collection chamber may include a vent adjacent to the first end of the collection chamber, the opening of which is in fluid communication with the vent while the collection chamber is in the first position, and the opening which is sealed from the vent while the collection chamber is in the second position. The plunger may include a sealing member adjacent to the end of the plunger, the sealing member of which includes an overmolded portion. The sample collection device may include a shroud coupled to the main body portion such that the shroud encloses at least a portion of the plunger. The shroud may include a projection configured to interface with the collection chamber to prevent the collection chamber from translating beyond the first position. The sample collection device may further include a shroud coupled to the main body portion adjacent to the second end of the main body, the shroud configured to receive a portion of the collection chamber and fix the collection chamber in the second position.

[0008] Another set of embodiments relates to a sample collection device for collecting biological samples for analysis within a detection system. The sample collection device is coupled to a main body and includes a collection chamber extending from a first collection chamber end to a second collection chamber end. The collection chamber includes an opening adjacent to the second collection chamber end. The opening is configured to receive a first volume of biological sample. The sample collection device includes a projection extending into the collection chamber. The collection chamber is configured to translate between a first position and a second position relative to the projection, and as the collection chamber translates from the first position to the second position, a second volume of biological sample is discharged from the collection chamber through the opening.

[0009] According to various embodiments, the collection chamber includes a vent adjacent to a first collection chamber end, the opening being in fluid communication with the vent while the collection chamber is in a first position, and the opening being sealed from the vent while the collection chamber is in a second position.

[0010] Exemplary embodiments are described below with reference to the attached drawings. Similar figures represent similar elements. [Brief explanation of the drawing]

[0011] [Figure 1A] A schematic diagram of an analyte detection system for analyzing the presence, absence, and / or quantity of one or more target analytes in a collected sample is provided, according to an exemplary embodiment, showing unconnected components. [Figure 1B] A schematic diagram of an analyte detection system for analyzing the presence, absence, and / or quantity of one or more target analytes in a collected sample is provided according to an exemplary embodiment, showing the components coupled for analysis and charging. [Figure 1C] A schematic diagram of another analyte detection system for analyzing the presence, absence, and / or quantity of one or more target analytes in a collected sample is provided according to an exemplary embodiment, and a charger is not provided. [Figure 2] An illustrative perspective view of a sample collection device in a first orientation, according to an exemplary embodiment, is shown. [Figure 3] Figure 2 shows a perspective view of the sample collection device with the shroud removed. [Figure 4] Figure 2 illustrates a perspective view of the sample collection device in the second orientation. [Figure 5] Figure 4 shows a perspective view of the sample collection device with the shroud removed, illustrating this point. [Figure 6] Let's illustrate this with an exploded view of the sample collection device shown in Figure 2. [Figure 7] Figure 2 shows a cross-sectional view of the sample collection device, illustrating this point. [Figure 8A] Figure 2 illustrates a partial cross-sectional view of the sample collection device. [Figure 8B] Figure 2 illustrates a partial cross-sectional view of the sample collection device. [Figure 9] Figure 2 illustrates the perspective view of the collection chamber of the sample collection device. [Figure 10] Figure 9 shows another perspective view of the collection chamber, illustrating this point. [Modes for carrying out the invention]

[0012] The following detailed description refers to the accompanying drawings which form part of this specification. The embodiments described in the drawings and description are intended to be illustrative and not limiting. Where used herein, the term “example” means “to serve as an example or illustration” and should not necessarily be construed as being preferable or advantageous to other embodiments. Other embodiments may be utilized and modified without departing from the scope of the subject matter presented herein. As described and illustrated herein, aspects of this disclosure may be arranged, combined, modified and designed in a variety of different configurations, all of which are expressly construed and form part of this disclosure.

[0013] One aspect of this disclosure relates to a system for detecting molecules. In various embodiments, the system includes a cartridge device, a reader device detachably coupled to the cartridge device, and a sample collection device. According to various embodiments, the sample device is configured to be exposed to a sample for analysis, and the sample collection device receives the sample for medical testing. The sample collection device may be further configured to be inserted into the cartridge device, and the cartridge device may be inserted into the reader device. The cartridge device and / or the reader device may be used to perform medical testing on a portion of the sample collected by the sample collection device.

[0014] Sample collection devices in various embodiments are configured to collect samples from specimens. A sample collection device may be configured to collect cells and other biomaterials such as urine, blood, plasma, and saliva. One exemplary sample collection device includes a sample collection chamber configured to aspirate a first volume of urine and selectively distribute a second volume of urine into the opening of a cartridge device. In other embodiments, a sample collection device may be configured to collect biomaterials, particulate matter, or other chemicals from the environment, such as from a liquid like tap water, or from a physical surface or other structure.

[0015] Sample collection devices in various embodiments are sized and shaped to collect a sufficiently large sample from a suitable location on a specimen and dispense a precise volume of sample, thereby enabling the detection of the presence, absence, and / or quantity of one or more target analytes in and / or on the specimen using other devices described below. For example, a sample collection device configured to collect urine may be suitable for collecting target analytes for various tests, including, for example, tests to track testosterone levels, drug levels, vitamin levels, and / or fertilization. Furthermore, a sample collection device may be suitable for collecting target analytes associated with one or more blood disorders, such as HIV. According to various embodiments, a sample collection device may be configured to collect fluids such as urine, blood, plasma, or saliva and may include a function to compress the wicking portion of the device and eject a precise volume of sample absorbed onto the wicking portion for analysis of the ejected sample.

[0016] In various embodiments, the cartridge comprises a housing that defines an opening and a sealed space. The cartridge has various functions that enable it to receive a sample containing a target analyte from a sample collection device, store the sample using a sample preparation reagent, provide a space for mixing and binding the target analyte with the sample preparation reagent, provide an analysis zone where the bound target analyte is localized for detection on a sensor, provide a fluid medium for transporting the bound target analyte to the analysis zone, store and provide a substrate that can undergo a detectable reaction when introduced to the bound target analyte, provide a fluid medium for transporting the substrate to the bound target analyte within the analysis zone, and provide a waste collection zone where waste is stored, among one or more of these actions.

[0017] In various embodiments, the cartridge is a substantially closed system in which the reactions necessary to detect the presence, absence, and / or amount of one or more target analytes occur within the cartridge. The cartridge of such embodiments is said to be "substantially closed" because the only inputs necessary to the cartridge system are one or more of a sample from a specimen, energy to facilitate mixing and binding, and a magnetic force to facilitate the localization of the bound target analyte within the analysis zone. The only output from the cartridge is an electrical signal. In various embodiments, the cartridge is target analyte specific, with included sample preparation reagents selected to detect one or more specific target analytes. Different cartridge types contain different reagents intended to identify different target analytes. For example, different cartridge types can include inflammation, influenza, testosterone, fertility, HIV, and vitamin D, each containing use-specific reagents intended to identify different target analytes.

[0018] Referring now to FIGS. 1A and 1B, an analyte detection system according to an exemplary embodiment is shown. The detection system 100 may include a sample collection device 200, a cartridge device 300, a reader device 400, a charger 500, and / or a software-based detection interface system 600. The detection system 100 may be used to detect the presence, absence, and / or amount of one or more target analytes.

[0019] The sample collection device 200 is configured to be exposed to a sample for analysis. For example, the sample collection device 200 may be exposed to a biological sample such as blood, plasma, urine, saliva, mucus, cellular material, and / or other biological materials to determine the presence, absence, and / or amount of one or more target analytes in the sample, but is not limited thereto. According to various embodiments, the sample collection device 200 is configured to be immersed in a container that holds the sample. For example, the container may be used to collect urine, and a portion of the sample collection device 200 may be immersed in the urine to collect the sample.

[0020] The cartridge device 300 is configured to analyze a sample collected using the sample collection device 200. The cartridge device 300 may include an input tunnel 301 that extends into the cartridge housing from an aperture 302. The input tunnel 301 is configured to allow insertion of the sample collection device 200, as shown in FIG. 1B, whereby the collected sample can be analyzed within the cartridge device 300. The cartridge device 300 is configured to generate an electrical signal indicative of the presence, absence, and / or amount of one or more target analytes in the sample based on the analysis.

[0021] The reader device 400 is configured to electrically couple with the cartridge device 300 to enable the transmission of electrical signals indicating the presence, absence, and / or quantity of one or more target analytes in a sample generated by the cartridge device 300. The cartridge device 300 may be electrically coupled to the reader device 400 by inserting the cartridge device 300 into the reader opening 401 of the reader device 400, as shown in Figure 1B, thereby causing the respective electrical connectors of the cartridge device 300 and the reader device 400 to make contact with each other. The reader device 400 may include a computer-readable medium containing instructions, when executed by the processor of the reader device 400, that cause the electrical components of the cartridge device 300 to perform steps for analyzing a sample on the sample collection device 200. According to various embodiments, for example, as shown in Figure 1B, the instructions are not executed until the cartridge device 300 is electrically coupled to the reader device 400 and the sample collection device 200 is suitably disposed within the cartridge device 300.

[0022] In one embodiment, the sample collection device 200 and the cartridge device 300 are each disposable and designed for single use, while the reader device 400 is designed for multiple uses and is designed to accept many different cartridge devices throughout the lifespan of the reader device 400, so that many samples are analyzed by the reader device 400 to determine the presence, absence, and / or quantity of one or more target analytes in each sample. Such a configuration is expected to promote hygienic use of the system because the components exposed to the sample are disposable, while reducing costs because components with more expensive electronics, such as the reader device 400, can be reused.

[0023] The charger 500 is configured to charge one or more batteries in the reader device 400, for example, via induction coils disposed within the housings of the charger 500 and the reader device 400. The charger 500 may be plugged into a conventional socket, for example, via a cord or a cord with an AC-DC power converter, in order to charge the components within the charger 500 and enable charging of the reader device 400.

[0024] It should be understood that the detection system does not require a charger. For example, referring to Figure 1C, the detection system 100' is configured similarly to the detection system 100 in Figures 1A and 1B, and similar components are identified by similar reference numbers with dashes. Thus, for example, the cartridge device 300' in Figure 1C corresponds to the cartridge device 300 in Figures 1A and 1B, etc. As can be observed by comparing Figures 1C and 1B, the detection system 100' does not include a charger 500. In such embodiments, the reader device 400' may be plugged into a conventional socket, for example, via a cord or a cord with an AC-DC power converter, to supply power to the components of the reader device 400', and / or the reader device 400' may include a suitable battery, such as a replaceable battery or a rechargeable battery, and the reader device 400' may include a circuit for charging the rechargeable battery and a detachable power cord.

[0025] In Figures 1A and 1B, according to various exemplary embodiments, a software-based detection interface system 600 is installed and runs on a computing device 601, allowing a user to review analyte detection test results, for example, on the display 602 of the computing device 601. The computing device 601 may be, for example, a smartphone, smartwatch, tablet, wearable device, laptop, or other computer. As shown in Figures 1A and 1B, the reader device 400 may communicate wirelessly with the computing device 601 to transmit data indicating the presence, absence, and / or quantity of one or more target analytes based on electrical signals generated in the cartridge device 300. In addition, or alternatively, a detachable wired connection, such as a cable connection, may be provided between the reader device 400 and the computing device 601. The software-based detection interface system 600 may include a computer-readable medium having instructions that, when executed by the processor of the computing device 601, cause the display 602 to display information indicating the presence, absence, and / or quantity of one or more target analytes. It should be understood that, according to various embodiments, the software-based detection interface system 600 may be omitted from the detection system 100. For example, the reader device 400 may include a display or other visual display system that provides results and / or other information to the user of the detection system 100 without requiring an external computing device 601 and / or the software-based detection interface system 600.

[0026] Referring here to Figures 2 to 5, an exemplary embodiment of the sample collection device 700 is illustrated. The sample collection device 700 may share one or more features with other sample collection devices described herein (e.g., sample collection device 200). For example, the sample collection device 700 may be used in conjunction with the detection system 100 in the same or similar manner as the sample collection device 200, as described above.

[0027] The sample collection device 700 is configured to collect a sample and distribute a desired volume of the sample to a desired location to be analyzed. The sample collection device 700 is configured to be fully or partially inserted into the cartridge device 300 after sample collection. The sample collection device 700 extends along the axis 701 from a first sample collection device end 702 to a second sample collection device end 704. The sample collection device 700 includes a body 800, which includes a handle portion 802. During use, the user can grasp the sample collection device 700 via the handle portion 802. The handle portion 802 includes multiple ridges, which can increase the frictional force between the user's fingers and the handle portion 802 to improve the user's grip.

[0028] The sample collection device 700 includes a shroud 900 (see Figures 2 and 4) coupled to the main body 800 between a first sample collection device end 702 and a second sample collection device end 704. As shown in Figures 2 and 4, various components are positioned at least partially within the internal volume of the shroud 900. Therefore, Figures 3 and 5 illustrate the sample collection device 700 with the shroud 900 removed to provide a better understanding of the sample collection device 700.

[0029] The sample collection device 700 includes a collection chamber 1000 adjacent to a second sample collection device end 704. The collection chamber 1000 includes an opening 1030 adjacent to the second sample collection device end 704. When the sample collection device 700 is in a first orientation and the collection chamber 1000 is in a first position (for example, as shown in Figures 2 and 3), the opening 1030 is configured to be exposed to the sample so that a minimum desired volume (e.g., a first volume) of the sample is collected into the internal volume of the collection chamber 1000. For example, the sample collection device 700 may include a wick 1100 (see Figure 6) positioned within the collection chamber 1000. When the opening 1030 is exposed to the sample (e.g., immersed in urine), the wick 1100 functions to absorb a minimum desired volume of the sample through the opening 1030, as discussed herein. Once the sample is absorbed by the wick 1100, the air located within the collection chamber 1000 may be released through one or more vents 1020 within the collection chamber 1000.

[0030] The sample collection device 700 is further configured to discharge a desired volume (e.g., a second volume) from the collection chamber 1000 through the opening 1030. The collection chamber 1000 is configured to discharge a desired volume of sample by translating along the axis 701 (e.g., relative to the body 800) between a first orientation (e.g., shown in Figures 2 and 3) and a second position (e.g., shown in Figures 4 and 5). For example, after a first volume of sample has been collected in the collection chamber 1000 while the collection chamber 1000 is in the first position, an axial force can be applied (e.g., along the axis 701) to the second sample collection device end 704 to move the collection chamber 1000 from the first position to the second position, thereby placing the sample collection device 700 in the second orientation. When the collection chamber 1000 transitions to a second position (for example, as shown in Figures 4 and 5), the plunger 820 translates into the collection chamber 1000, and a desired volume (for example, a second volume) of sample is discharged from the opening 1030, as will be further described below. According to various embodiments, the sample collection device 700 is inserted into the aperture 302 within the cartridge device 300 until the second sample collection device end 704 interfacially bonds with a rigid structure within the aperture 302. The user may continue to push the sample collection device 700 into the aperture 302, thereby generating a minimum axial force acting on the second sample collection device end 704, which in turn translates the collection chamber 1000 along axis 701 from the first position to the second position, distributing the sample into the aperture 302.

[0031] As shown, the main body 800 includes a shoulder 826 configured to restrict the translation of the collection chamber 1000 along the axis 701. For example, when the collection chamber 1000 is in a second position, the first collection chamber end 1002 interfacially bonds with the shoulder 826 to prevent the collection chamber 1000 from translating further toward the first sample collection device end 702. By limiting the distance the collection chamber 1000 translates along the axis 701, the volume of sample released from the opening 1030 can be controlled. Furthermore, the total volume released from the opening 1030 when the collection chamber 1000 translates from the first position to the second position depends on the distance the collection chamber 1000 translates along the axis 701. Thus, the sample collection device 700 can be configured to distribute sample volumes within a predetermined range of volumes (e.g., greater than or equal to a minimum desired volume and less than or equal to a maximum desired volume) by adjusting the distance the collection chamber 1000 moves between the first and second positions.

[0032] As will be further discussed herein, when the sample collection device 700 is removed from its package and the shoulder 826 limits the total distance the collection chamber 1000 can move along axis 701 so that a predetermined volume of sample is released from the collection chamber 1000, the collection chamber 1000 can be fixed in a first position via one or more tabs (e.g., projections 1010 shown in Figure 10). The distribution of a predetermined volume of sample is expected to improve the accuracy of analyte analysis, as a substantially known amount of sample is analyzed.

[0033] According to various embodiments, at least a portion of the collection chamber 1000 is transparent, allowing the collector to verify that the wick 1100 is sufficiently saturated. For example, the wick 1100 may include an indicator 1110 (such as a colored thread, as shown in Figure 8A) embedded within the wick 1100. When the wick 1100 is saturated, the indicator 1110 within the wick becomes visible through the transparent portion of the collection chamber 1000, which can indicate to the user that a sufficient volume (e.g., a first volume) has been collected.

[0034] It should be understood that in some exemplary embodiments, the volume of sample collected by the sample collection device 700 can be greater than the volume of sample released by the sample collection device 700. For example, the wick 1100 may be configured to absorb a first volume of sample (e.g., when fully saturated). Since the range of motion of the collection chamber 1000 is limited (e.g., via the shoulder 826), the sample collection device 700 may be configured to distribute a second volume of sample less than the first volume. In other words, the sample collection device 700 may release all of the sample absorbed by the wick, and after use, the excess sample can be discarded along with the sample collection device 700. The sample collection device 700 may be pre-packaged in sterile packaging and configured for single use.

[0035] Referring now to Figure 6, an exploded view of the sample collection device 700 is shown. The sample collection device 700 includes a body 800, a plunger 820, a shroud 900, a collection chamber 1000, and a wick 1100. Although some components are shown as separate components, it should be understood that one or more of the components may be formed integrally with each other. For example, the body 800 and the plunger 820 are shown as integrally formed components in Figure 6.

[0036] The main body 800 extends from a first main body end 812 to a second main body end 814. As discussed above, the main body 800 includes a handle portion 802 adjacent to the first main body end 812. The handle portion 802 is configured to be held by the user during sample collection. The main body 800 further defines a shoulder 826 adjacent to the second main body end 814. The shoulder 826 defines an outer diameter larger than the inner diameter of the collection chamber 1000 so as to prevent the collection chamber 1000 from translating beyond a desired position relative to the plunger 820.

[0037] The plunger 820 includes a projection 821 extending from the body 800 adjacent to the second body end 814. For example, the projection 821 is shown to extend from the first plunger end 822 (adjacent to, for example, the shoulder 826) to the second plunger end 824. The projection 821 defines an elongated body configured to be received within the internal volume of the collection chamber 1000.

[0038] The plunger 820 further includes a sealing member 830. As shown in the figure, projection 821 defines a sealing ring 828 adjacent to the second plunger end 824. The sealing ring 828 is configured to receive the sealing member 830 and to connect the sealing member 830 to projection 821. The sealing member 830 may include a sealing ring 832, which interfacially bonds with the inner wall of the collection chamber 1000 and is configured to prevent the sample from flowing over the sealing ring 832 or to reduce the amount of sample that flows over the sealing ring 832. For example, the sealing ring 832 defines a diameter that is the same as or slightly larger than the inner diameter of the collection chamber 1000 so that the sealing ring 832 compresses within the collection chamber 1000 to create a seal. According to various embodiments, the sealing ring 832 is formed of an elastic material such as rubber or polyvinyl.

[0039] According to various embodiments, the sealing member 830 is overmolded onto a projection 821 adjacent to the second plunger end 824. For example, the sealing member 830 may be overmolded onto the projection 821 as part of the manufacturing process. According to various embodiments, the relatively small size of the sealing member 830 may make it difficult to join the sealing member 830 to the projection 821 after both components of the sealing member 830 and the projection 821 have been formed separately. Therefore, in some exemplary embodiments, overmolding the sealing member 830 onto the end of the projection 821 may reduce the manufacturing time and difficulty associated with assembling the sample collection device 700.

[0040] Referring further to Figure 6, the collection chamber 1000 extends from the first collection chamber end 1002 to the second collection chamber end 1004. The collection chamber 1000 includes a projection 1010 adjacent to the first collection chamber end 1002. As will be discussed further below, the projection 1010 interface with a projection 920 of the shroud 900 (see Figure 8B) to prevent the collection chamber 1000 from translating away from the shroud 900. Furthermore, as will be discussed further below, the projection 1010 interface with a recess 910 of the shroud 900 (see Figure 8B) to restrict unwanted movement of the collection chamber 1000 into the shroud. For example, a minimum threshold axial force (e.g., around axis 701) may be required to translate the collection chamber 1000 from a first position to a second position.

[0041] Continuing to refer to Figure 6, the collection chamber 1000 further includes a vent 1020 adjacent to the first collection chamber end 1002. The vent 1020 is configured to allow air to escape from the collection chamber 1000 when a sample is drawn into the collection chamber through the opening 1030 while the collection chamber 1000 is in a first position. For example, when the collection chamber 1000 is in a first position, the sealing ring 832 may be positioned between the first collection chamber end 1002 and the vent 1020 so that the opening 1030 is in fluid communication with the vent 1020. Since the vent 1020 and the opening 1030 are in fluid communication, a sample can be drawn into the collection chamber 1000 and air can be released from the vent 1020. According to various embodiments, the collection chamber 1000 includes a plurality of vents 1020 surrounding the collection chamber 1000. For example, the collection chamber 1000 may include two or more vents that are equally spaced around the collection chamber 1000.

[0042] As the collection chamber 1000 is translated toward the second position, the sealing ring 832 passes through the vent 1020 and is positioned between the vent 1020 and the second end of the collection chamber 1004. After the sealing ring 832 has passed through the vent 1020, the vent 1020 is blocked from the opening 1030 so that the vent 1020 and the opening 1030 are no longer in fluid communication. As the plunger 820 is translated into the collection chamber 1000, the wick 1100 is compressed, thereby pushing at least a portion of the collected sample out of the opening 1030. The sealing ring 832 blocks the vent 1020 from the wick 1100 so that the sample is not pushed out of the opening 1030 and released from the vent 1020.

[0043] Referring here to Figures 7 to 8B, cross-sectional and partial cross-sectional views of the sample collection device 700 are shown, respectively. The collection chamber 1000 is shown in the first position in Figures 7 to 8B. Furthermore, the collection chamber 1000 is configured to translate from the first position to the second position along the axis 701 with respect to the shroud 900 and the plunger 820. According to various embodiments, the shoulder 826 of the body 800 prevents the collection chamber 1000 from moving beyond the second position. Since the distance the collection chamber 1000 moves from the first position to the second position is predetermined, the sample collection device 700 is configured to dispense a precise volume of sample for analysis (for example, into the aperture 302 of a cartridge device 300).

[0044] The collection chamber 1000 includes a projection 1010 that is received in a recess 910 (e.g., a stopper) within the shroud 900 while the collection chamber 1000 is in a first position. The projection 1010 includes an inclined surface, as shown in Figure 10, which interface with the recess 910 such that the collection chamber 1000 moves only from the first position toward the second position in response to a minimum axial force applied to the end 704 of the second sample collection device. Since only a minimum force is required to translate the projection 1010 out of the recess 910, the possibility of accidental sample ejection can be reduced. For example, if the end 704 of the second sample collection device is subjected to an accidental axial force less than the required minimum axial force, the collection chamber 1000 may not translate along axis 701 toward the second position.

[0045] The collection chamber 1000 includes an angled edge 1120 adjacent to the second sample collection device end 704. The angled edge 1120 forms an angle 1101 with respect to the axis 701. The angle 1011 may be less than 90 degrees. For example, the angle 1001 may be less than 60 degrees. For example, the angle 1001 may be approximately 45 degrees. The angled edge 1120 is configured to interfacially bond with an angled surface corresponding to the aperture 302 of the cartridge device 300, which may facilitate the centering of the collection chamber 1000 within the aperture 302. According to various embodiments, centering the collection chamber within the aperture 302 may reduce the risk of compressing the wick 1100 before the second sample collection device end 704 is positioned in the desired location.

[0046] The projection 1010 is further configured to interface with projection 920 in the shroud 900 to prevent the collection chamber 1000 from translating beyond the first position (for example, to prevent the collection chamber 1000 from being detached from the shroud 900). The distance between the first position and the second position can also be controlled by controlling the position of the collection chamber 1000 while the collection chamber 1000 is in the first position, so that the collection chamber 1000 is configured to dispense a precise volume of collected sample.

[0047] The wick 1100 includes an indicator 1110. According to various embodiments, the wick 1100 may be opaque before the sample is collected, such that the indicator 1110 (e.g., a colored thread) is not visible or is otherwise difficult to see (e.g., through the transparent portion of the collection chamber 1000). As the wick 1100 draws out the sample and becomes at least partially saturated, the indicator 1110 within the wick may become visible. For example, as the sample is absorbed by the wick 1100 so that the indicator 1110 is visible, the wick 1100 may become more transparent. Once the user can see the indicator 1110, the wick 1100 may be sufficiently saturated, and a desired volume may be released from the sample collection device 700 (e.g., in response to the sample collection device 700 being inserted into the cartridge device 300).

[0048] As shown in Figure 8B, the collection chamber 1000 includes a projection 1010 (e.g., a shoulder) adjacent to the first collection chamber end 1002. The projection 1010 interfacially bonds with a projection 920 extending from the inner surface of the shroud 900 to prevent the collection chamber 1000 from translating away from the shroud 900 (e.g., to prevent the collection chamber 1000 from translating beyond a first position).

[0049] Referring here to Figures 9 and 10, perspective views of the collection chamber 1000 are shown. The collection chamber 1000 is configured to collect a sample and release a precise volume of the collected sample for analysis. The collection chamber 1000 extends from a first collection chamber end 1002 to a second collection chamber end 1004. The collection chamber 1000 includes an opening 1030, shown as a plurality of apertures 1032 adjacent to the second collection chamber end 1004. The plurality of apertures 1032 are equally spaced around a central axis (e.g., axis 701 shown in Figure 8A). According to various embodiments, the plurality of apertures 1032 can distribute the sample in a relatively evenly distributed manner when released from the collection chamber 1000.

[0050] Unless otherwise defined, each technical or scientific term used herein has the same meaning as that commonly understood by those skilled in the art to which this disclosure pertains. According to the following claims and disclosures provided herein, the following terms are defined as follows, unless otherwise expressly stated:

[0051] The terms "approximately" or "nearly," when used before a numerical notation or range (e.g., pressure or dimension), indicate an approximation that may vary by only (+) or (-) 5%, 1%, or 0.1%.

[0052] Where used herein and in the claims, the singular forms “a,” “an,” and “the” refer to both singular and plural objects unless otherwise clearly indicated by the context. For example, the term “molecule” may and is assumed to include multiple molecules. Sometimes, the claims and disclosures may include terms such as “multiple,” “one or more,” or “at least one,” but the absence of such terms is not intended to mean that plural is not assumed, nor should it be interpreted as meaning that plural is not assumed.

[0053] As used herein and in the claims, “at least one of” means including, but not limited to, one or more of any combinations of the following: For example, “at least one of A, B, and C” or “at least one of A, B, or C” means, but not limited to, A(plural) or B(plural) or C(plural) or A(plural) and B(plural) or A(plural) and C(plural) or B(plural) and C(plural) or A(plural) and B(plural) and C(plural) or A(plural) and B(plural) and C(plural) and none of them exclude other elements such as D(plural), E(plural).

[0054] Where used herein, the terms “comprising” or “comprises” are intended to mean that a device, system, and method includes the enumerated elements and may additionally include any other elements. “Essentially consisting of” means that a device, system, and method includes the enumerated elements and excludes other elements that are essentially important to the combination for the specified purpose. Thus, a device or method that is essentially consisting of elements as defined herein would not exclude other materials or steps that do not substantially affect the basic and novel features of the claimed invention. “Consists of” means that a device, system, and method includes the enumerated elements and excludes any elements or steps that are trivial or insignificant. Embodiments defined by each of these transitional terms are within the scope of this disclosure.

[0055] While the above includes illustrative and detailed descriptions of several embodiments, it will be readily apparent to those skilled in the art that, in light of the teachings of these embodiments, numerous changes and modifications can be made without departing from the spirit or scope of the appended claims.

Claims

1. A sample collection device for collecting biological samples for analysis in a detection system, A main body portion extending along the main body axis from the first main body end to the second main body end, A collection chamber connected to the main body portion and extending from the end of a first collection chamber to the end of a second collection chamber, wherein the collection chamber includes an opening adjacent to the end of the second collection chamber, and the opening is configured to receive the biological sample. A wick positioned within the collection chamber, wherein the wick is configured to receive the biological sample through the opening and to store a first volume of the biological sample, A plunger, which extends from the main body portion in close proximity to the second end of the main body, thereby positioning a portion of the plunger within the collection chamber, A sample collection device wherein the collection chamber is configured to translate along the axis of the main body relative to the plunger between a first position and a second position, and by translating the collection chamber from the first position to the second position, a second volume of the biological sample is released from the wick and distributed from the opening in the collection chamber.

2. The sample collection device according to claim 1, wherein the first volume is larger than the second volume.

3. The sample collection device according to claim 1, wherein the main body portion includes a shoulder adjacent to the second end of the main body, and the shoulder prevents the collection chamber from translating beyond the second position.

4. The sample collection device according to claim 1, wherein the collection chamber includes a vent adjacent to the first end of the collection chamber, the opening is in fluid communication with the vent while the collection chamber is in the first position, and the opening is not in fluid communication with the vent while the collection chamber is in the second position.

5. The sample collection device according to claim 4, wherein the vent is one of a plurality of vents equally spaced around the outer diameter of the collection chamber.

6. The sample collection device according to claim 1, wherein the plunger includes a sealing member adjacent to the end of the plunger, and the sealing member includes an overmolded portion.

7. The sample collection device according to claim 1, further comprising a shroud coupled to the main body portion and encompassing at least a portion of the plunger, wherein the shroud includes a projection configured to interfacially bond with the collection chamber to prevent the collection chamber from translating beyond a first position.

8. The sample collection device according to claim 1, wherein the opening is one of a plurality of openings equally spaced around the end of the second collection chamber.

9. The sample collection device according to claim 1, further comprising a shroud coupled to the main body portion adjacent to the second end of the main body, wherein the shroud is configured to receive a portion of the collection chamber and fix the collection chamber to the second position.

10. The sample collection device according to claim 1, wherein the collection chamber includes a transparent portion, thereby allowing the wick to be visible through the transparent portion.

11. The sample collection device according to claim 10, wherein the wick is configured to make a visual indicator visible when the wick receives the biological sample and the wick becomes saturated.

12. It is a system, A cartridge device having a cartridge opening, A sample collection device configured to collect a biological sample for analysis and discharge the biological sample into the cartridge opening, wherein the sample collection device is A main body portion extending along the main body axis from the first main body end to the second main body end, A collection chamber is inserted into the cartridge opening, coupled to the main body portion, and configured to extend from the end of a first collection chamber to the end of a second collection chamber, wherein the collection chamber includes an opening adjacent to the end of the second collection chamber, and the opening is configured to receive the biological sample. A wick positioned within the collection chamber, wherein the wick is configured to receive the biological sample through the opening and to store a first volume of the biological sample, A plunger, which extends from the main body portion in close proximity to the second end of the main body, thereby positioning a portion of the plunger within the collection chamber, The collection chamber is configured to translate relative to the plunger between a first position and a second position along the axis of the main body in response to an axial force applied to the main body portion while the collection chamber is positioned within the cartridge opening. A system in which the collection chamber is translated from the first position to the second position, thereby releasing a second volume of the biological sample from the wick and distributing it to the cartridge opening.

13. The system according to claim 12, wherein the first volume is greater than the second volume.

14. The system according to claim 12, wherein the main body portion includes a shoulder adjacent to the second end of the main body, the shoulder preventing the collection chamber from translating beyond the second position.

15. The system according to claim 12, wherein the collection chamber includes a vent adjacent to the first end of the collection chamber, the opening being in fluid communication with the vent while the collection chamber is in the first position, and the opening not being in fluid communication with the vent while the collection chamber is in the second position.

16. The system according to claim 12, wherein the plunger includes a sealing member adjacent to the end of the plunger, and the sealing member includes an overmolded portion.

17. The system according to claim 12, further comprising a shroud coupled to the main body portion such that the shroud encompasses at least a portion of the plunger, the shroud including a projection configured to interface with the collection chamber so as to prevent the collection chamber from translating beyond the first position.

18. The system according to claim 12, further comprising a shroud coupled to the main body portion adjacent to the second end of the main body, wherein the shroud is configured to receive a portion of the collection chamber and fix the collection chamber in the second position.

19. A sample collection device for collecting biological samples for analysis in a detection system, A collection chamber connected to the main body portion and extending from the end of a first collection chamber to the end of a second collection chamber, wherein the collection chamber includes an opening adjacent to the end of the second collection chamber, and the opening is configured to receive a first volume of the biological sample; A sample collection device comprising a projection extending within the collection chamber, wherein the collection chamber is configured to translate relative to the projection between a first position and a second position, and by translating the collection chamber from the first position to the second position, a second volume of the biological sample is discharged from the collection chamber through the opening.

20. The sample collection device according to claim 19, wherein the collection chamber includes a vent adjacent to the first end of the collection chamber, the opening is in fluid communication with the vent while the collection chamber is in the first position, and the opening is not in fluid communication with the vent while the collection chamber is in the second position.

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