Swab assembly and assay system
Through the cooperation of the swab device made of injection molded plastic and the annular blade part, combined with the design of locking sheets and foils, the problem of poor sample collection and retention in the prior art is solved, and more efficient biological sample collection and Determine the safety and accuracy of the system.
Patent Information
- Application Number
- CN202380037171.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-04-29
- Filing Date
- 2023-04-26
- Publication Date
- 2025-01-03
AI Technical Summary
There is room for improvement in existing swab components and assay systems in terms of safety and effectiveness, especially in sample collection tip materials and design, which makes it difficult to effectively collect and retain biological samples and ensure the accuracy of sample size.
A swab device made of injection molded plastic is adopted, and the sample collection tip has multiple equidistant linear grooves and is used in conjunction with the annular blade part. The metering device is engaged with the swab device through the annular blade part to ensure the sample's Collect and retain, the assay system prevents the swab device from retraction by the design of locking sheets and foils, and controls the propulsion and determination of the sample through a stepper motor.
More efficient biological sample collection and retention is achieved, ensuring sample sizes are within a narrow range, improving the accuracy and safety of the assay, and has advantages over traditional soft sample collection tip swab devices.
Smart Images
Figure CN119255765A_ABST
Abstract
Description
background Technical Field
[0002] The present disclosure generally relates to swab assemblies, including nasal swab assemblies for collecting biological specimens, and assay systems, including systems capable of receiving such swab assemblies.
[0003] Description of Related Technology
[0004] A variety of swabs and assay devices are commercially available. However, there is room for improvement in these devices, including with respect to safety and efficacy.
[0005] Brief Overview
[0006] The swab assembly can be summarized as comprising: a swab device; and a metering device; wherein the swab device extends through the interior of the metering device. The swab device can be made of a single integral piece of injection molded plastic. The swab device can have a sample collection tip and a plurality of grooves formed on the outer surface of the sample collection tip. The plurality of grooves can include four grooves, and the four grooves are circumferentially spaced from each other equidistantly around the outer surface of the sample collection tip. Each of the grooves can be linear and aligned with the central longitudinal axis of the swab device. Each of the grooves can be longer than the distance from the groove to the end tip of the swab device. Each of the grooves can have a width of about 0.5 mm, a depth of about 0.34 mm, and a length of about 4.52 mm. The metering device can include an annular blade portion engaged with the outer surface of the sample collection tip of the swab device. The annular blade portion can engage with the outer surface of the sample collection tip of the swab device with an interference fit.
[0007] An assay system configured to receive a swab device may be summarized as comprising: a substantially cylindrical body; an open window extending through a sidewall of the substantially cylindrical body; and a locking tab extending from the substantially cylindrical body and partially through the open window; wherein the locking tab is configured to engage with the swab device to prevent the swab device from being withdrawn out of the assay system. The locking tab may extend along an axis substantially aligned with a central longitudinal axis of the assay system and may extend at least partially inwardly into the interior of the substantially cylindrical body. The system may further include a first foil; wherein the swab device pierces the first foil when the swab device is inserted into the assay system. The system may further include a second foil; wherein the window is configured to receive a tool, the tool being configured to interact with the swab device to move the swab device when the swab device is inside the substantially cylindrical body, and wherein the swab device pierces the second foil when the swab device is moved by the tool. The tool may be configured to be controlled by a stepper motor.
[0008] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0009] Figure 1 A perspective view of a swab assembly is shown.
[0010] Figure 2 Shows Figure 1 A cross-sectional view of a swab assembly.
[0011] Figure 3 Shows Figure 1 A perspective view of the metering device of the swab assembly.
[0012] Figure 4 Shows Figure 1 A perspective view of a swab device of a swab assembly.
[0013] Figure 5 Shows Figure 4 A first side view of a swab tip of a swab device.
[0014] Figure 6 Shows Figure 4 A second side view of a swab tip of a swab device opposite to the first side view.
[0015] Figure 7 shows a device configured to receive Figure 4 A perspective view of a portion of an assay system of a swab device.
[0016] Figure 8 Shows Figure 7 Another perspective view of a portion of an assay system.
[0017] Fig. 9 Shows Figure 7 A perspective view of some components of a portion of an assay system, including a first foil or membrane.
[0018] Fig.10 Shows Fig. 9 The same components as part of the measurement system Fig. 9 , with the first foil or film removed.
[0019] Fig.11 Shows Figure 7 A perspective view of some components of a portion of an assay system, including a second foil or membrane.
[0020] Fig.12 Shows Fig.11 The same components as part of the measurement system Fig.11 , with the second foil or film removed.
[0021] Detailed Description
[0022] In the following description, certain specific details are set forth to provide a thorough understanding of the various disclosed embodiments. However, one skilled in the relevant art will recognize that the embodiments may be practiced without one or more of these specific details, or with other methods, components, materials, etc. In other instances, well-known structures associated with the technology are not shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.
[0023] Figure 1 A perspective view of the swab assembly 100 is shown, and Figure 2 A cross-sectional view of the swab assembly 100 is shown. Figure 1 and Figure 2 As shown, the swab assembly 100 includes an outer metering device 102 , which may be referred to as a “squeegee,” and an inner swab device 104 , which may extend through the interior of the metering device 102 . Figure 3 The metering device 102 is shown by itself, with the swab device 104 removed, and Figure 4 The swab device 104 is shown by itself, with the metering device 102 removed. Figure 5 and Figure 6 An opposing side view of a sample collection tip portion of the swab device 104 is shown, with the view exaggerated to improve visibility of features therein.
[0024] like Figure 5 and Figure 6As shown, an O-ring seal 106 can be located on the swab device 104 adjacent to the sample collection tip of the swab device 104. The O-ring seal 106 can provide a seal to other components such as an assay system. In some embodiments, the entirety of the swab device 104, except for the O-ring seal 106, can be made from a single, integral piece of injection molded plastic material. This is different from many existing or conventional swab devices, which include a soft sample collection tip. Also, as shown in FIG. Figure 5 and Figure 6 As specifically shown, the sample collection tip portion of the swab device 104 includes a plurality of grooves 108 formed on an outer surface thereof. In the illustrated embodiment, the swab device 104 includes four grooves 108 equidistantly spaced from one another circumferentially around the outer surface of the sample collection tip portion of the swab device 104. However, in alternative embodiments, the swab device 104 may include other numbers of grooves 108, such as one, two, three, five, six, eight, ten, twelve, or more grooves 108. Further, in alternative embodiments, the grooves 108 may be unequally spaced from one another.
[0025] In the illustrated embodiment, each of the grooves 108 is linear and extends along a respective axis that is parallel to the central longitudinal axis of the swab device 104 as a whole and to the axes of the other grooves 108. In alternative embodiments, the grooves may have other shapes and / or may follow other paths such that, for example, they are not parallel to the central longitudinal axis of the swab device 104 and / or are not parallel to each other. In the illustrated embodiment, each of the grooves 108 has a respective first end that is closest to the tip of the proximal end of the swab device 104, and the first ends of the grooves 108 are collectively located on a single circle centered on the central longitudinal axis of the swab device 104 and in a single plane perpendicular to the central longitudinal axis of the swab device 104. Thus, the first ends of the grooves 108 are equidistant from the tip of the proximal end of the swab device 104. In the illustrated embodiment, each of the grooves 108 has a respective second end that is farthest from the adjacent end tip of the swab device 104, and the second ends of the grooves 108 are collectively located on a single circle centered on the central longitudinal axis of the swab device 104 and in a single plane perpendicular to the central longitudinal axis of the swab device 104. Therefore, the second ends of the grooves 108 are equidistant from the adjacent end tip of the swab device 104.
[0026] Thus, each of the grooves 108 has the same total length from its respective first end to its respective second end. In some embodiments, the total length of the grooves 108 is greater than the distance from the first end of the grooves 108 to the adjacent end tip of the swab device 104. For example, the length of the grooves 108 can be at least two, three, or four times the distance from the first end of the grooves 108 to the adjacent end tip of the swab device 104. In some embodiments, the grooves 108 can have a width or thickness greater than 0.1 mm, 0.2 mm, 0.3 mm, or 0.4 mm, and / or less than 0.6 mm, 0.7 mm, 0.8 mm, or 0.9 mm, or about 0.5 mm. In some embodiments, the grooves 108 can have a depth greater than 0.1 mm, 0.2 mm, or 0.3 mm, and / or less than 0.4 mm, 0.5 mm, 0.6 mm, or 0.7 mm, or about 0.34 mm. In some embodiments, the groove 108 can have a length greater than 1.0 mm, 2.0 mm, 3.0 mm, or 4.0 mm, and / or less than 5.0 mm, 6.0 mm, 7.0 mm, or 8.0 mm, or approximately 4.52 mm.
[0027] like Figure 1 and Figure 2 As specifically shown, the swab assembly 100 including the metering device 102 and the swab device 104 can be provided as an assembled unit, wherein the swab device 104 is located within and extends through a cavity within the metering device 102. The metering device 102 includes an annular blade portion 110 that engages with an outer surface of a sample collection tip portion of the swab device 104, such as with an interference fit, so that the annular blade portion 110 contacts and engages and presses against the outer surface of the sample collection tip portion of the swab device 104.
[0028] In practice, a patient, physician or other medical professional, or user or operator of the swab assembly 100 may insert the sample collection tip of the swab device 104 into the patient's nostril and rotate the sample collection tip of the swab assembly 100 several times (e.g., five times) within the patient's nostril to collect a biological sample on the swab assembly 104. The user or operator may then insert the sample collection tip of the swab device 104 into the patient's other nostril and rotate the sample collection tip of the swab assembly 100 several times (e.g., five times) therein to collect an additional biological sample on the swab assembly 104. Once the sample has been collected on the sample collection tip of the swab assembly 100, the user or operator may remove the sample by pulling the swab device 104 through the metering device 102 (i.e., by rotating the swab assembly 104 in the same manner as described above). Figure 2 The swab device 104 is removed from the metering device 102 by pulling the swab device 104 upward relative to the metering device 102 in the direction shown.
[0029] When the user or operator removes the swab device 104 from the metering device 102 in this manner, the annular blade portion 110 of the metering device 102 slides over the length of the sample collection tip of the swab device 104. In doing so, the metering device 102 wipes off the sample collected on the outer surface of the sample collection tip of the swab device 104, but leaves the sample retained in the groove 108, given the engagement between the annular blade portion 110 of the metering device 102 and the outer surface of the sample collection tip of the swab device. In this sense, the metering device 102 acts as a squeegee and meters the volume of the sample collected and retained on the sample collection tip of the swab device 104. For example, the volume of the sample collected and retained for further determination may be 0.01 to 1.00 microliters. In other words, the metering device 102 can be used to ensure that the volume of the sample collected and retained for further determination conforms to a relatively narrow volume range (e.g., two orders of magnitude), which is narrower than many existing or conventional swab devices with soft sample collection tips, and may be advantageous in subsequent determinations.
[0030] In some embodiments, the metering device 102 and / or the swab device 104 can be partially or completely made of a hard plastic material and / or a flexible or elastic material. In the illustrated embodiment, the sample collection tip portion of the swab device 104 has a circular or cylindrical cross-sectional profile. In alternative embodiments, the profile can have other shapes, including oval, elliptical, triangular, square, etc. Such shapes can be selected to improve performance in terms of sample collection, comfort, metering, etc.
[0031] Figure 7 and Figure 8 A perspective view of an assay system 200 configured to receive a swab device 104 is shown. Figure 7 and Figure 8 As shown, the measuring system 200 has a generally cylindrical shape and has a first opening or hole 202 at its first end along its central longitudinal axis, through which the swab device 104 can be longitudinally inserted into the measuring system 200. Figure 7 and Figure 8 As shown, the assay system 200 includes a second opening or window 204 that extends through a side wall of the assay system 200 and through which a tool may be inserted into the assay system 200 to operate on the assay system 200 and / or the swab device 104 therein. Figure 7 and Figure 8As further shown, the assay system 200 includes a protrusion, clip, finger, or locking tab 206. The locking tab 206 extends from a first side wall of the window 204 proximate the hole 202 into the window 204 and slightly radially inward into the interior of the assay system 200 along an axis that is substantially aligned with the central longitudinal axis of the assay system 200.
[0032] Fig. 9 and Fig.10 The assay system 200 is shown to include a first foil or membrane 208 proximate to the aperture 202 through which the swab device 104 is inserted into the assay system 200 . Fig.11 and Fig.12 The assay system 200 is shown to include a second foil or membrane 210 distal from the aperture 202 through which the swab device 104 is inserted into the assay system 200 (relative to the first foil or membrane 208). The assay system 200 can have a first internal reaction chamber located between and sealed from the external environment by the first and second foils or membranes 208, 210, and a second internal reaction chamber located within a tip 212 of the assay system 200 distal from the aperture 202 through which the swab device 104 is inserted into the assay system 200. Each of these chambers can contain various reagents or other materials for performing an assay on a biological sample collected on the sample collection tip of the swab device 104.
[0033] In use, once the user or operator has removed the swab device 104 from the metering device 102, the user or operator may longitudinally insert the sample collection tip portion of the swab device 104 through the aperture 202 into the assay system 200. When the swab device 104 is longitudinally inserted into the assay system 200 through the aperture 202 in this manner, the swab device 104 contacts the locking tab 206, temporarily moving the locking tab 206 radially outward as the wider portion of the swab device 104 passes through the locking tab 206, and allowing the locking tab 206 to return radially inward as the narrower portion of the swab device 104 passes through the locking tab 106. When this occurs, tactile feedback is provided to the user by the action of the locking tab 206 interacting with the swab device 104. The operator may press the swab device 104 into the assay system until the distal surface of the swab device 104 is flush with the distal surface of the assay system 200. When the swab device 104 is fully inserted into the assay system 200 in this manner, the locking tab 206 engages with a flange or other mechanical component of the swab device 104 to prevent the swab device 104 from being withdrawn directly out of the assay system 200 through the aperture 202. Additionally, when the swab device 104 is inserted in this manner, the sample collection tip portion of the swab device 104 can pierce the first foil or membrane 208 and introduce the biological sample into the reagents in the first internal reaction chamber for reaction and assay therein.
[0034] The user or operator can insert the assay system 200 into a base station for further manipulation, testing, and reaction and / or assay steps. Once the assay system 200 has been inserted into the base station, the swab device 104 can be manipulated through the window 204 and further pushed along the central longitudinal axis of the assay system 200. For example, in some embodiments, the user or operator can extend a finger or tool into the assay system 200 through the window 204 to further push the swab device 104 along the central longitudinal axis of the assay system 200. In other embodiments, the base station can include a stepper motor and an actuator controlled by the stepper motor, the stepper motor being configured to engage the swab device 104 through the window 204 and further push the swab device 104 along the central longitudinal axis of the assay system 200. When the swab device 104 is pushed in this manner, the sample collection tip of the swab device 104 can pierce the second foil or membrane 210 and introduce the biological sample or its product into the reagent in the second internal reaction chamber for further reaction and assay therein.
[0035] In the illustrated embodiment, the metering device 102 and its annular blade portion 110 are components of the swab assembly 100. However, in alternative embodiments, the metering device 102 and / or its annular blade portion 110 may be components of the assay system 200. In such an embodiment, the metering device 102 and / or the annular blade portion 110 may remain stationary while the swab device 104 and the sample collection tip of the swab device 104 are pushed through the metering device 102 and / or the annular blade portion 110. In such an embodiment, the movement of the sample collection tip of the swab device 104 through the annular blade portion 110 may be automated and / or controlled by a base station (e.g., by a stepper motor), and the metering device 102 and / or its annular blade portion 110 may be made of a resilient material.
[0036] Aspects of the various embodiments described above can be combined to provide further embodiments. These and other changes can be made to the embodiments in light of the above detailed description. Generally, in the appended claims, the terms used should not be interpreted as limiting the claims to the specific embodiments disclosed in the specification and claims, but should be interpreted as including all possible embodiments and the full range of equivalents to which these claims are entitled.
Claims
1. Swab assembly, including: Swab device; as well as Metering devices; Wherein the swab device extends through the interior of the metering device.
2. The swab assembly of claim 1, wherein the swab device is made from a single integral piece of injection molded plastic. 3 . The swab assembly according to claim 1 , wherein the swab device has a sample collection tip portion and a plurality of grooves formed on an outer surface of the sample collection tip portion. 4 . The swab assembly of claim 3 , wherein the plurality of grooves comprises four grooves that are equally spaced from one another circumferentially around the outer surface of the sample collection tip.
5. The swab assembly of claim 3, wherein each of the grooves is linear and aligned with a central longitudinal axis of the swab device.
6. The swab assembly of claim 3, wherein each of the grooves is longer than a distance from the groove to a distal tip of the swab device.
7. The swab assembly of claim 3, wherein each of the grooves has a width of about 0.5 mm, a depth of about 0.34 mm, and a length of about 4.52 mm.
8. The swab assembly of claim 1, wherein the metering device comprises an annular blade portion engaged with an outer surface of a sample collection tip portion of the swab device.
9. The swab assembly of claim 8, wherein the annular blade portion engages an outer surface of the sample collecting tip portion of the swab device with an interference fit.
10. An assay system configured to receive a swab device, comprising: A substantially cylindrical body; an open window extending through a side wall of the substantially cylindrical body; as well as a locking tab extending from the substantially cylindrical body and partially extending through the open window; The locking piece is configured to engage with the swab device to prevent the swab device from being withdrawn out of the assay system.
11. The assay system of claim 10, wherein the locking tab extends along an axis substantially aligned with a central longitudinal axis of the assay system and extends at least partially inwardly into the interior of the substantially cylindrical body.
12. The assay system according to claim 10, further comprising: First foil; Wherein, when the swab device is inserted into the measuring system, the swab device pierces the first foil.
13. The assay system according to claim 12, further comprising: a second foil; wherein the window is configured to receive a tool configured to interact with the swab device to move the swab device when the swab device is inside the substantially cylindrical body, and wherein the swab device pierces the second foil when the swab device is moved by the tool.
14. The assay system of claim 13, wherein the tool is configured to be controlled by a stepper motor.