Portable kits and devices for detecting or identifying diseases or disorders by collecting biological samples from human subjects

Abstract

Portable kits and devices are provided for detecting or identifying a disease or disorder by obtaining a biological sample from a human subject. [Solution] A device for detecting or identifying a disease or disorder by collecting a biological sample from a human subject includes a pump unit, a first unit, a second unit, a breathable filter, and a collector. The first unit includes a first chamber and a gas detection unit. The second unit includes a second chamber, an outlet portion, and an inlet portion. The breathable filter is provided in an upstream region of the second chamber. The collector is provided in a downstream region of the second chamber. The pump unit is configured, when activated, so that the outlet portion generates negative pressure in an airflow path formed by communication between the first chamber and the second chamber, forcibly guiding ambient airflow from the outside through the inlet portion and into the second chamber and the first chamber.

Description

[Technical Field]

[0001] The present invention relates to the technical field of biotechnical detection devices, and more particularly to portable kits and devices for detecting or identifying diseases or disorders by taking biological samples from human subjects. [Background technology]

[0002] Clinical decision-making is largely based on laboratory test and physical examination data, but traditional testing processes can take days or even weeks to complete. Obtaining accurate test information early during patient triage (determining treatment priorities during disasters, etc.) would help facilitate earlier treatment and improve the efficiency of disease management, leading to improved treatment outcomes and reduced healthcare costs.

[0003] There is currently a need to analyze analytes in the field, or without the use of expensive and difficult-to-operate auxiliary equipment in hospitals, laboratories, or testing facilities. In many cases, there is a need for a device that is portable and easy to operate, without the need for additional equipment. Furthermore, in some practical applications, the ability to detect analytes from fluids in real time or near real time is a necessary or desirable characteristic. Furthermore, accuracy and reliability are important factors when performing such detection. Summary of the Invention

[0004] The present invention discloses an apparatus for detecting or identifying a disease or disorder by collecting a biological sample from a human subject, the apparatus comprising: a pump unit, a first unit, a second unit, a breathable filter, and a collector, the first unit including a first chamber in fluid communication with the pump unit and a gas detection unit disposed within the first chamber, the second unit including a second chamber, an outlet in fluid communication between the second chamber and the first chamber, and an inlet in fluid communication between the second chamber and the outside, the pump unit configured such that, when activated, the outlet generates negative pressure in an airflow path formed by communication between the first chamber and the second chamber, and ambient airflow is forcibly guided from the outside through the inlet and flows into the second chamber and the first chamber. The breathable filter is disposed in an upstream region of the second chamber, and the collector is disposed in a downstream region of the second chamber, the collector configured to temporarily fix a biological sample from a human subject. A purified airflow is generated from an ambient airflow drawn through the breathable filter and carries volatile compounds of the biological sample from the second chamber to the first chamber. [Brief explanation of the drawings]

[0005] [Figure 1] FIG. 1 is a perspective view of a portable kit of the present invention. [Figure 2] FIG. 2 is a side cross-sectional view of the portable test device shown in FIG. [Figure 3] FIG. 3 is an exploded view of the portable test device shown in FIG. [Figure 4] FIG. 4 is an exploded view of the box component shown in FIG. [Figure 5] FIG. 5 is an enlarged view of a portion of the portable test device. [Figure 6] FIG. 6 is an enlarged fragmentary view of another portion of the portable test device. [Figures 7A-7D] 7A to 7D are process diagrams for analyzing biological samples according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0006] The definitions of terms defined and used herein take precedence over dictionary definitions, definitions in cited documents, and / or ordinary meanings of the defined terms. Unless clearly stated to the contrary, the indefinite articles "a" and "a kind" as used in this specification and claims should be understood to mean "at least one."

[0007] The present invention relates to portable devices and kits for detecting or identifying diseases or disorders by collecting biological samples from humans. In one example, the devices and kits preferably detect analytes in one or more biological samples from humans. The biological sample may be a bodily fluid or secretion, such as exhaled breath, exhaled breath, vaginal secretions, blood, serum, urine, saliva, cerebrospinal fluid, sweat, tears, vaginal fluid, mucus, or semen.

[0008] FIG. 1 illustrates a portable kit for use in analyzing at least one analyte in a body fluid or secretion, the kit including a collection tool 10 and a test module 20.

[0009] The collection tool 10 includes an absorbent portion 11 connected to the rod portion 12, and a rod portion 12 (sometimes called a collector) designed to collect or temporarily secure a biological sample from a human subject. In this example, the collection tool 10 may be a swab. The test module 20 includes a portable test device 21 and a box portion 22.

[0010] 2 and 3 , the portable test device 21 includes a head portion 211, a housing 212, a cavity 213 (sometimes referred to as a second unit, and the interior space of the cavity 213 is sometimes referred to as a second chamber), a pump 214 (sometimes referred to as a pump unit), a controller 215, and a battery element 216. The head portion 211 is attached to a top end 2121 of a housing 212, which includes a first half 2122 and a second half 2123, and the cavity 213, the pump 214, the controller 215, and the battery element 216 are provided inside the housing 212. The portable test device 21 further includes a sensing unit 217 provided in the cavity 213, which may be a gas sensing circuit including one or more gas sensors. The gas sensor may be a solid-state semiconductor sensor capable of adaptively reacting with a biological sample from a human subject, and the sensing unit 217 is connected to the controller 215. The controller 215 includes a processor that determines whether the results of the reaction between the gas sensor and the biological sample correspond to results associated with one or more diseases or disorders. The pump 214 is operably connected to the cavity 213 and generates a negative pressure in the cavity 213.

[0011] Referring to FIG. 4 , the box part 22 (sometimes referred to as a first unit, and the internal space of the box part 22 as a first chamber) holds the biological sample. The box part 22 may include a base 221 (sometimes referred to as an outlet part), a lid part 222 (sometimes referred to as an inlet part), a cutting element 223, and a breathable filter 224. The base 221 includes a housing 2211, a bottom partition 2212, one or more exhaust holes 2213, a duct wall 2214, and a top opening 2215. The housing 2211 is generally cylindrical and extends longitudinally. The bottom partition 2212 is disk-shaped and is disposed within the housing 2211. The bottom partition 2212 has a base and an outer edge. The duct wall 2214 extends upward from the periphery of the base to define a cavity 2216. A vent hole 2213 is provided at the outer edge of the bottom partition 2212. A cutting element 223 is provided above the top opening 2215 and is located above the tube wall 2214, thereby exposing a cavity 2216 to the interior of the base 221.

[0012] The cutting element 223 includes a sleeve 2231, an annular portion 2232, an axial bore 2233, and a blade structure 2234. The sleeve 2231 is designed to be received within the housing 2211. The blade structure 2234 is formed at the peripheral edge of the axial bore 2233, and the blade structure 2234 may include a plurality of sawtooth formed along the periphery of the axial bore 2233, and the blade structure 2234 cuts the collection tool 10, leaving the absorbent portion 11 in the cavity 2216, as will be further described below.

[0013] The cavity 2216 is aligned with the axial hole 2233 to accommodate the collection tool 10 after cutting. The exhaust holes 2213 are located on the outer edge of the bottom divider 2212 to prevent the biological sample from spilling out of the exhaust holes 2213.

[0014] The lid component 222 may include a main body 2221, a top portion 2222, an aperture 2223, and a bottom opening 2224. The main body 2221 and the top portion 2222 may collectively be referred to as a housing, and the main body 2221 is generally cylindrical and defines an interior space 2225. The aperture 2223 is formed in the top portion 2222 to allow gas or liquid to pass through. The interior space 2225 has a first area 2225a and a second area 2225b, where the first area 2225a is closer to the top portion 2222 and the second area 2225b is closer to the bottom opening 2224. The first area 2225a may be defined as an upstream area of ​​the second chamber, and the second area 2225b may be defined as a downstream area of ​​the second chamber.

[0015] The breathable filter 224 can be formed as a barrel-shaped structure and mounted within the first area 2225a, and can be inserted into the first area 2225a and cover the opening 2223. In one example, the breathable filter 224 is a carbon filter.

[0016] The lid component 222 is configured to releasably fit over, securely engage, or otherwise connect to the base 221, thereby forming a substantially watertight and airtight seal between the lid component 222 and the base 221. When the lid component 222 is attached to the base 221, the tube wall 2214 and the cutting element 223 are contained within the second area 2225b of the lid component 222.

[0017] The box part 22 holds the absorbent part 11 of the collection tool 10. In this example, the collection tool 10 is a cotton swab, and the biological sample is deposited in or absorbed by the absorbent part 11. Before testing, the cover part 222 is separated from the base 221, and the collection tool 10 is placed into the base 221. As shown in FIG. 5 , the collection tool 10 is inserted into the axial hole 2233, so that the disposable part 10a of the collection tool 10 is positioned above the axial hole 2233 and the holding part 10b (sometimes called a collector) is positioned below the axial hole 2233, and the holding part 10b includes at least a portion of the absorbent part 11. When the rod part 12 of the collection tool 10 is moved, the collection tool 10 is cut by the blade structure 2234, and the holding part 10b is released from the disposable part 10a. Because the axial hole 2233 and the cavity 2216 are coaxially aligned, the holding part 10b falls into the cavity 2216 after release. Next, the cover part 222 is attached to the base 221 again.

[0018] Because the lid part 222 and the base 221 are connected in a watertight and airtight manner, gas flows from the opening 2223 through the breathable filter 224 and downward to the exhaust hole 2213, and the biological sample attached to or absorbed in the absorption section 11 is transported along with the gas flow flowing through the chamber defined by the lid part 222 and the base 221 or the surrounding gas flow.

[0019] In this example, the box component 22 is configured to be assembled into the portable test device 21. In some cases, the lid component 222 and the breathable filter 224 can be assembled into the portable test device 21 independently as a single unit, without including the base 221 and the cutting element 223, as will be described later.

[0020] The size and shape of the head portion 211 of the portable test device 21 are designed to accommodate the box member 22. As shown in Fig. 2, the head portion 211 includes a tube portion 2110, an insertion portion 2111, a valve member 2112, and a stopper 2113. The tube portion 2110 includes a hollow portion that fits into the base 221 of the box member 22. The portable test device 21 may further include a removable lid member 218 connected to the tube portion 2110. The insertion portion 2111 is provided within the hollow portion and includes a fixed holding portion 2111a, a circumferential extending portion 2111b, an outer protruding edge 2111c, a top edge 2111d, and a communicating pipe 2111e. The fixed holding portion 2111a is formed as a cylindrical groove, thereby operably connected to the valve component 2112, the circumferential extending portion 2111b and the outer protruding edge 2111c protrude radially outward from the fixed holding portion 2111a, which may be annular in shape, the circumferential extending portion 2111b can be adaptively connected to the first half 2122 and the second half 2123 of the housing 212, the outer protruding edge 2111c can be adaptively connected to the lower receiving portion 2217 of the base 221, and the communicating pipe 2111e opens in the cylindrical groove of the fixed holding portion 2111a and is in fluid communication with the cavity 213 via a first connecting pipe 219a. As shown in FIG. 2, the cavity 213 is further in fluid communication with the pump 214 via a second connecting pipe 219b.

[0021] 6, when the lower support portion 2217 of the base 221 is assembled to the outer protruding edge 2111c of the insertion portion 2111, an annular chamber is formed between the lower edge of the base 221 and the upper edge of the insertion portion 2111, and an annular gap is formed between a stepped portion in the lower support portion 2217 and the top edge 2111d of the insertion portion 2111. The valve component 2112 is disposed between the lower support portion 2217 of the base 221 and the fixed holder 2111a, and includes a valve body 2112a, one or more air inlet ports 2112b, an annular rib 2112c, a lower chamber 2112d, an upper recess 2112e, and a lower recess 2112f. The valve body 2112a is formed as a vertical tube and designed to engage with the cylindrical groove of the fixed holder 2111a.

[0022] The air inlet 2112b passes axially through the center of the valve body 2112a and is in fluid communication with the lower chamber 2112d. The annular rib 2112c extends outward along the outer periphery of the valve body 2112a and is located in the annular gap formed between the stepped portion of the lower receiving portion 2217 and the top edge 2111d of the insertion portion 2111. O-rings are provided in the upper recess 2112e and the lower recess 2112f to ensure that the valve body 2112a, the base 221, and the insertion portion 2111 are sealed together in a watertight and airtight manner.

[0023] The stopper 2113 is disposed within the mounting portion 2111 and is located between the bottom wall of the mounting portion 2111 and the lower chamber 2112d, and includes a circular baffle 2113a and a pillar 2113b, which is fixed to the bottom wall of the mounting portion 2111 and the circular baffle 2113a is disposed on the pillar 2113b. The diameter of the circular baffle 2113a is larger than the opening of the lower support portion 2217, and the diameter of the pillar 2113b is smaller than the opening of the lower support portion 2217, so that the circular baffle 2113a is suspended within the mounting portion 2111.

[0024] The circular baffle 2113a is made of a material having elastic deformation ability, and when the pump 214 is turned off and there is no negative pressure in the cavity 213 (or the cylindrical groove of the fixed holding portion 2111a), the circular baffle 2113a seals and closes the opening of the lower receiving portion 2217 (i.e., it is in a normal state), i.e., the fluid communication between the cylindrical groove of the fixed holding portion 2111a and the lower chamber 2112d of the valve component 2112 is closed.

[0025] When the pump 214 is activated and negative pressure is generated in the cavity 213, the suction force bends the circular baffle 2113a downward, forming an annular gap between the lower receiving portion 2217 and the deformed circular baffle 2113a, thus opening the lower receiving portion 2217 and allowing fluid communication between the cylindrical groove of the fixed holding portion 2111a and the lower chamber 2112d of the valve component 2112.

[0026] The following is a detailed process of an example of a diagnostic test method. In operation, a pre-cleaning step is first performed, and then the box part 22 containing no biological sample is assembled into the portable test device 21, as shown in FIG. 7A. The base 221 is inserted into the insertion part 2111, thereby fluidly connecting the cavity 2216, the exhaust hole 2213, the lower support part 2217, and the valve part 2112 along the vertical direction. This places the valve part 2112 and the lower chamber 2112d of the valve part 2112 in fluid communication with the connecting pipe 2111e. After the installation is complete, a gas flow path is established from the opening 2223 of the cover part 222 through the breathable filter 224, the exhaust hole 2213, the air inlet 2112b of the valve part 2112, and the connecting pipe 2111e, in this order, to the cavity 213. When pump 214 is activated, ambient air 90 is drawn into cavity 213 along the gas flow path, where it is purified after passing through breathable filter 224, and purified air 91 (also called purified airflow) flows along the gas flow path due to the suction generated by pump 214. When pump 214 is turned off, purified air 91 is retained within cavity 213, thereby ensuring that the test environment contains few or only very low concentrations of airborne particles or contaminants.

[0027] Alternatively, the pre-cleaning step may not necessarily involve the base 221 and cutting element 223, as shown in Figure 7A. In other words, the pre-cleaning step may involve only the lid piece 222 and the breathable filter 224. The breathable filter 224 is placed in the lid piece 222, which is then connected to the portable test device 21.

[0028] After the pre-cleaning step is completed, a biological sample is subsequently obtained from the human subject. The biological sample can be obtained by scraping, wiping, or sectioning. In one embodiment, the biological sample is obtained using a collection tool 10, such as a brush, a cotton swab, a spatula, a rinsing or cleaning solution, a punching and slicing device, a needle puncture cavity, or a surgical instrument. After the biological sample is obtained from the human subject with the collection tool 10, the cover part 222 is removed from the base 221 (see FIG. 7B), and the collection tool 10 is inserted into the base 221 of the box part 22, as shown in FIG. 7C.

[0029] Next, as described above, the collecting tool 10 is folded to retain the holding portion 10b within the cavity 2216 of the base 221, and after the holding portion 10b containing the absorbent portion 11 is retained in the base 221, the lid part 222 with the breathable filter 224 attached thereto is reattached to the base 221, thereby obtaining the assembled box part 22, see FIG. 7D.

[0030] Next, the pump 214 is started again, and the outside air 90 is drawn along the gas flow path into the cavity 213. Volatile compounds (e.g., volatile organic compounds (VOCs)) derived from the biological sample then flow into the cavity 213 together with the purified air 91 (purified airflow).

[0031] Compounds in the biological sample can react with the gas sensor, and the reaction can be analyzed by a processor to determine whether the reaction between the gas sensor and the biological sample is consistent with an outcome associated with one or more diseases or disorders.

[0032] One advantage of the present invention is that analysis of biological samples can be performed in a clean environment by performing a pre-cleaning step prior to analysis. Furthermore, by placing a filter material in the gas flow path and containing the biological sample within the box components, the effects of ambient air contamination can be minimized. Removable and replaceable box components are also advantageous for point-of-care testing. [Explanation of symbols]

[0033] 10 Collection Tools 10a Disposable part 10b Holding part 11 Absorption section 12 Rod section 20 Test Modules 21 Portable Test Equipment 211 Head 2110 Pipe section 2111 Insertion part 2111a Fixed holding part 2111b Circumferential extension part 2111c Outer protruding edge 2111d Apical margin 2111e Connecting pipe 2112 Valve parts 2112a Valve body 2112b Air supply port 2112c Annular rib 2112d Lower Chamber 2112e Upper recess 2112f Lower recess 2113 Plug body 2113a Circular Baffle 2113b Columnar part 212 Housing 2121 Apex 2122 First Half 2123 Second Half 213 Cavity 214 Pump 215 Controller 216 Battery Elements 217 Detection Unit 218 Removable lid part 219a First connecting pipe 219b Second connecting pipe 22 Box parts 221 Base 2211 Housing 2212 Bottom partition plate 2213 Exhaust vent 2214 Tube wall 2215 Top opening 2216 Cavity 2217 Lower receiving part 222 Lid parts 2221 Main unit 2222 Top 2223 Open hole 2224 Bottom opening 2225 Interior Space 2225a First Area 2225b Second Area 223 Cutting Elements 2231 Sleeve 2232 Circular section 2233 Shaft hole 2234 Blade structure 224 Breathable Filter 90 Outside air 91 Purified Air

Claims

1. 1. An apparatus for detecting or identifying a disease or disorder by obtaining a biological sample from a human subject, comprising: A pump unit; a first unit including a first chamber in fluid communication with the pump unit and a gas detection unit disposed within the first chamber; a second unit including a second chamber, an outlet portion fluidly communicating between the second chamber and the first chamber, and an inlet portion fluidly communicating between the second chamber and the outside, wherein the pump unit is configured such that, when activated, the outlet portion generates a negative pressure in an airflow path formed by communicating the first chamber and the second chamber, and ambient airflow is forcibly guided from the outside through the inlet portion and flows into the second chamber and the first chamber; a breathable filter provided in an upstream region of the second chamber; a collector disposed in a downstream region of the second chamber, the collector configured to temporarily fix a biological sample from a human subject; a purified airflow is generated from ambient airflow drawn through the breathable filter and carries volatile compounds of the biological sample from the second chamber to the first chamber; A device for detecting or identifying a disease or disorder by taking a biological sample from a human subject.

2. a housing having a head portion and a slot formed in the head portion; a valve body disposed within the slot of the housing; a controller; and the first unit, the pump unit, and the controller are provided inside the housing; the second unit is releasably coupled to the slot of the housing and is in fluid communication with the second unit via the valve body; 2. The device for detecting or identifying a disease or disorder by collecting a biological sample from a human subject as described in claim 1, wherein a removable cover part is provided on the slot when the second unit is not coupled to the slot of the housing.

3. The second unit comprises: a base including a bottom partition, one or more exhaust holes extending through the bottom partition, a tube wall extending upwardly from the bottom partition and defining a cavity, and a top opening located above the tube wall, the exhaust holes being in fluid communication with the first chamber; a lid part attached to the base to form the second chamber, the lid part including a housing defining an internal space, an aperture formed at a top of the housing, and a bottom opening; The upstream region of the second chamber is adjacent to the opening, the downstream region of the second chamber is adjacent to the upstream region, the breathable filter is provided in the upstream region and seals the opening, and the pipe wall is located within the downstream region; the hollow portion of the base is covered from above by the breathable filter and is circumferentially sealed by the housing; a cutting element is provided in the top opening, the cutting element including an axial hole and a blade structure formed on a periphery of the axial hole; 2. The device for detecting or identifying a disease or disorder by obtaining a biological sample from a human subject as recited in claim 1, wherein said aperture is coaxially aligned with said axial aperture.

4. 1. A portable kit for detecting or identifying a disease or disorder by obtaining a biological sample from a human subject, comprising: a collection tool including an absorbent portion and an extension portion connected to the absorbent portion, the absorbent portion configured to temporarily immobilize a biological sample from a human subject; a test module, A pump unit; a first unit including a first chamber in fluid communication with the pump unit and a gas detection unit disposed within the first chamber; a second unit including a second chamber, an outlet portion fluidly communicating between the second chamber and the first chamber, and an inlet portion fluidly communicating between the second chamber and the outside, wherein the pump unit is configured such that, when activated, the outlet portion generates a negative pressure in an airflow path formed by communicating the first chamber and the second chamber, and ambient airflow is forcibly guided from the outside through the inlet portion and flows into the second chamber and the first chamber; a breathable filter provided in an upstream region of the second chamber; a test module including: Including, at least a portion of the absorbent portion of the collection tool is disposed within a downstream region of the second chamber; a purified airflow is generated from ambient airflow drawn through the breathable filter and carries volatile compounds of the biological sample from the second chamber to the first chamber; A portable kit for detecting or identifying a disease or disorder by obtaining a biological sample from a human subject.

5. a housing having a head portion and a slot formed in the head portion; a valve body disposed within the slot of the housing; a controller; and the first unit, the pump unit, and the controller are provided inside the housing; 5. A portable kit for detecting or identifying a disease or disorder by collecting a biological sample from a human subject as described in claim 4, wherein the second unit is releasably coupled to the slot of the housing and is in fluid communication with the second unit via the valve body.

6. The second unit comprises: a base including a bottom partition, one or more exhaust holes extending through the bottom partition, a tube wall extending upwardly from the bottom partition and defining a cavity, and a top opening located above the tube wall, the exhaust holes being in fluid communication with the first chamber; a lid part attached to the base to form the second chamber, the lid part including a housing defining an interior space, an aperture formed at a top of the housing, and a bottom opening; The upstream region of the second chamber is adjacent to the opening, the downstream region of the second chamber is adjacent to the upstream region, the breathable filter is provided in the upstream region and seals the opening, and the pipe wall is located within the downstream region; 5. A portable kit for detecting or identifying a disease or disorder by collecting a biological sample from a human subject as described in claim 4, wherein the cavity of the base is covered from above by the breathable filter and circumferentially sealed by the housing.

7. 7. The portable kit for detecting or identifying diseases or disorders by collecting biological samples from a human subject according to claim 6, wherein a cutting element is provided at the top opening, the cutting element including an axial hole and a blade structure formed around the axial hole, the collection tool is inserted into the axial hole so that the absorbent portion passes through the axial hole and a portion of the collection tool is close to the blade structure, and when the collection tool is forced toward the blade structure, the collection tool is cut by the blade structure into a disposable portion and a retaining portion, the retaining portion including at least a portion of the absorbent portion, and the retaining portion is contained within the cavity of the base after cutting.

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