Biosensor system and method of controlling the same

Abstract

The present invention relates to a biosensor system and a control method thereof. The control method of the biosensor system includes a shaft alignment step of aligning an actuator shaft of a valve actuator rotating a valve part provided in a biosensor cartridge and an actuator shaft of a pump actuator rotating a pump part to an initial position, a loading step of moving the valve actuator and the pump actuator downward when the biosensor cartridge is inserted, and a diagnosis step of rotating the valve part and the pump part to sense a biological substance, thereby achieving an effect that the biological substance can be automatically diagnosed by a simple process of inserting the biosensor cartridge into a diagnosis device.

Description

Technical Field

[0001] This invention relates to a biosensor system and its control method, and more specifically, to a biosensor system and its control method for detecting biological substances, generating electrical signals, sensing them, and diagnosing the biological substances. Background Technology

[0002] In recent years, with the development of science and technology and increased attention to quality of life, the importance of disease diagnosis and prevention, food, and the environment in people's lives has been growing. As a result, the necessity of measuring the concentration of organic or inorganic substances in samples for specific processes in the fields of food chemistry and industrial chemistry, or for analyzing pollutants in the environmental field, has gradually increased, and much effort has been put into this endeavor.

[0003] A biosensor is a device that integrates biological substances such as enzymes, microorganisms, antibodies, receptors, and DNA probes into an electrochemical or physicochemical element (transducer). It senses signals and measures concentrations of electrode-active substances or physical changes generated by the reaction with the analyte through electrochemical, optical, thermal, or piezoelectric methods.

[0004] In general, the detection of biological substances using biosensors involves a combination of complex processes such as filtering, metering, mixing, transporting, reacting, and washing. Therefore, historically, the detection of biological substances was performed manually in laboratory units utilizing various facilities.

[0005] Therefore, with the development of biosensor technology, the simultaneous development of fluid processing technologies to automate and standardize the diagnostic process has become very important in order to achieve low-cost and high-efficiency diagnosis.

[0006] Equipment used for biological substance detection requires cleaning the flow path before measuring each biological sample. To diagnose multiple samples, large volumes of buffer solution need to be stored in tanks, posing a risk of spoilage and necessitating the periodic emptying of waste solution after diagnosis. When using such equipment, diagnostic speed and accuracy decrease when diagnosing large numbers of samples, thus limiting its effectiveness.

[0007] To address this issue, disposable biosensor cartridges with built-in flow paths for buffer and sample solutions can be used. These cartridges are used only once, eliminating the need for separate cleaning processes. Furthermore, each cartridge is provided with a disposable buffer solution, eliminating the possibility of buffer solution deterioration. Finally, the waste solution can be emptied when the cartridge is discarded.

[0008] Relatedly, a field diagnosis molecular diagnostic system is disclosed in Korean Patent Publication KR10-2022-0047600A.

[0009] The aforementioned on-site diagnostic molecular diagnostic system includes a box and diagnostic instruments. Biological samples are stored in the box and inserted into the diagnostic instruments for various sample processing steps.

[0010] The aforementioned on-site diagnostic molecular diagnostic system is configured such that the box is inserted into the diagnostic instrument while standing upright in the vertical direction.

[0011] Furthermore, a pneumatic device is provided to allow the buffer solution or sample solution to flow. When the box is inserted, pneumatic power is supplied to the inside of the box to allow the buffer solution or sample solution to flow.

[0012] However, as mentioned above, when the box is inserted in a direction perpendicular to the ground, the buffer solution or sample solution may flow due to gravity. Therefore, the flow of the buffer solution or sample solution is independent of the operation of the diagnostic instrument and cannot be precisely controlled.

[0013] In addition, the relatively large pneumatic devices need to be installed in the diagnostic instruments, which can lead to an increase in the size of the diagnostic equipment, causing inconvenience when transporting it to the site where the diagnosis is needed or when setting it up on-site.

[0014] In addition, pneumatic devices are difficult to control in fine detail, making it difficult to control the flow rate and velocity of the buffer solution or sample solution flowing inside the box. This can lead to errors in diagnostic data, resulting in decreased accuracy and limitations. Summary of the Invention

[0015] Technical issues

[0016] The present invention was proposed to improve the problems mentioned above, and the purpose of the present invention is to provide a biosensor cartridge that allows users to easily diagnose biological substances through a simple process.

[0017] In addition, the present invention aims to provide a biosensor box that can easily diagnose biological substances at the site where diagnosis is needed, without spatial limitations.

[0018] In addition, the present invention aims to provide a biosensor box that can be compactly configured into the size of a diagnostic device, is easy to transport to the site where diagnosis is required, and can perform diagnosis without space limitations.

[0019] In addition, the present invention aims to provide a biosensor box that can stably control the flow rate and velocity of a buffer solution or sample solution flowing within the box.

[0020] In addition, the present invention aims to provide a biosensor cartridge that can prevent the decrease in sensing accuracy due to the inconsistent flow rate of the solution in each diagnostic biosensor cartridge.

[0021] In addition, the present invention aims to provide a biosensor box that can miniaturize the size of a biosensor while stably maintaining the flow of buffer solution or sample solution and stably transmitting electrical signals.

[0022] In addition, the present invention aims to provide a biosensor box that allows for easy replacement of only the biosensor without disassembling the entire box in the event of a biosensor failure.

[0023] In addition, the present invention aims to provide a biosensor cartridge that can be easily injected with a buffer solution and prevent the buffer solution from being contaminated.

[0024] In addition, the present invention aims to provide a biosensor cartridge that can automatically flow a buffer solution or sample solution to a biosensor and sense biological substances through the biosensor via a simple process of insertion into a diagnostic device.

[0025] means of solving technical problems

[0026] To address the aforementioned issues, the biosensor system of the present invention may include: a biosensor cartridge comprising: a frame disposed within a housing; a channel formed in the frame providing a flow path for a buffer solution or a sample solution; a biosensor attached to the frame for detecting biological material; and a pump unit for generating flow force on the buffer solution or sample solution flowing in the channel; and a diagnostic device comprising: a diagnostic device housing having a cartridge inlet for inserting the biosensor cartridge; and a pump actuator disposed within the diagnostic device housing and coupled to the pump unit to rotate the pump unit.

[0027] At this time, when the biosensor box is inserted into the diagnostic device, the pump actuator descends and engages with the pump unit.

[0028] Alternatively, the biosensor box may further include a valve that selectively opens or closes the buffer solution channel into which the buffer solution flows or the sample solution channel into which the sample solution flows, so that the buffer solution or the sample solution flows into the biosensor.

[0029] Alternatively, the diagnostic device may further include a valve actuator that is coupled to the valve knob of the valve section to rotate the valve knob.

[0030] At this time, when the biosensor box is inserted into the diagnostic device, the valve actuator descends and engages with the valve section.

[0031] Alternatively, the pump actuator may include: an actuator shaft that is coupled to the pump unit to rotate the pump unit; an alignment guide that has a larger diameter than the actuator shaft, forms a guide gap, and rotates integrally with the actuator shaft; and an alignment sensing unit that senses the position of the guide gap when the alignment guide rotates.

[0032] At this time, the pump actuator can rotate the actuator shaft before the biosensor box is inserted into the diagnostic device, thereby aligning the alignment sensing part and the guide slot onto a vertical line.

[0033] At this time, the aforementioned channel may include: a buffer solution channel, into which the buffer solution flows; a sample solution channel, into which the sample solution flows; and a sensing channel, which guides the buffer solution or the sample solution to the biosensor, wherein the valve connects the buffer solution channel and the sensing channel and then connects the sample solution channel and the sensing channel.

[0034] Alternatively, the aforementioned channel may also include a pre-filled channel, which is connected to the aforementioned sample solution channel, and the aforementioned sample solution flows in the pre-filled channel.

[0035] Alternatively, the valve section can connect the pre-filling channel and the sensing channel, and then connect the buffer solution channel and the sensing channel.

[0036] Alternatively, the pump actuator can be operated when the valve section stops rotating.

[0037] Alternatively, the valve actuator may include an actuator shaft that is coupled to the valve portion to rotate the valve portion, wherein the actuator shaft rotates one revolution after the valve actuator moves downward.

[0038] To address the aforementioned issues, the control method for the biosensor system of the present invention may include: an axis alignment step, aligning the actuator shaft of a valve actuator that rotates the valve section of the biosensor housing and the actuator shaft of a pump actuator that rotates the pump section to an initial position; a loading step, when the biosensor housing is inserted, causing the valve actuator and the pump actuator to move downwards; and a diagnostic step, rotating the valve section and the pump section to sense the biological substance.

[0039] At this point, in the above-mentioned shaft alignment step, the actuator shaft can be rotated, and the guide gap that rotates together with the actuator shaft can be sensed by the alignment sensing unit.

[0040] Alternatively, during the loading step described above, the loading plate, which is coupled with the valve actuator and the pump actuator described above, can be lowered and moved.

[0041] Alternatively, the diagnostic steps may include: a pre-loading step, in which the valve actuator is operated to rotate the connection channel formed in the valve section to a first position; a buffer solution circulation step, after the pre-loading step, in which the valve actuator is operated to rotate the connection channel to a second position different from the first position; and a sample solution circulation step, after the buffer solution circulation step, in which the valve actuator is operated to rotate the connection channel to a third position different from the first and second positions.

[0042] Invention Effects

[0043] As described above, the biosensor system according to the present invention has the following effect: by providing a valve section and a pump section in the biosensor box, biological substances can be automatically diagnosed through a simple process of inserting the biosensor box into a diagnostic device.

[0044] In addition, it has the following effect: by integrating the valve and pump into the biosensor box, the valve and pump can be operated without spatial limitations to sense biological substances when necessary.

[0045] In addition, it has the following advantages: the valve and pump sections are built into the biosensor box, so only a simple actuator is required in the diagnostic device. Therefore, the diagnostic device can be compactly constructed and is easy to transport, eliminating spatial limitations of the installation location.

[0046] In addition, it has the following effect: when the pump rotates, pressing the tube enables the buffer solution or sample solution to flow stably.

[0047] In addition, it has the following advantages: miniaturization and sensitive sensing can be achieved by using graphene-based biosensors.

[0048] In addition, it has the following effect: a hydrophilic adhesive layer using a hydrophilic band is formed between the bottom frame and the upper frame, so that the flow rate of the solution can be kept constant regardless of the environment in which the diagnosis is performed.

[0049] In addition, the present invention aims to provide a biosensor box that can miniaturize the size of a biosensor while stably maintaining the flow of buffer solution or sample solution and stably transmitting electrical signals.

[0050] In addition, it has the following effect: in the event of a biosensor failure, only the biosensor needs to be replaced after separating the sensor cover.

[0051] In addition, the presence of a buffer blister allows for easy injection of the buffer solution by simply breaking open the sealed blister, thus preventing contamination of the buffer solution.

[0052] In addition, the buffer solution and sample solution can be automatically flowed sequentially by rotating the valve. Attached Figure Description

[0053] Figure 1 This is a diagram illustrating a biosensor box and diagnostic device according to an embodiment of the present invention.

[0054] Figure 2 This is a perspective view illustrating a biosensor box according to an embodiment of the present invention.

[0055] Figure 3 yes Figure 2 An exploded 3D diagram.

[0056] Figure 4 yes Figure 2 Top view.

[0057] Figure 5 It is used for in Figure 4 A top view illustrating the state of the upper shell removed.

[0058] Figure 6 This is an exploded perspective view used to illustrate the framework of one embodiment of the present invention.

[0059] Figure 7 This is a top view used to illustrate the upper frame of one embodiment of the present invention.

[0060] Figure 8 This is a cross-sectional view of the frame according to an embodiment of the present invention.

[0061] Figure 9 This is a bottom view used to illustrate a channel formed on the upper frame in one embodiment of the present invention.

[0062] Figure 10 This is a diagram illustrating the combination of the frame, biosensor, and printed circuit board in a biosensor box according to an embodiment of the present invention.

[0063] Figure 11 This is a diagram illustrating the sensor junction in a biosensor box according to an embodiment of the present invention.

[0064] Figure 12 This is a diagram illustrating the state in which a biosensor is incorporated into a biosensor box according to an embodiment of the present invention.

[0065] Figure 13 This is a cross-sectional view illustrating the contact between the biosensor and the printed circuit board in a biosensor box according to an embodiment of the present invention.

[0066] Figure 14 and Figure 15 This is a cross-sectional view used to illustrate the configuration of the biosensor and printed circuit board in a biosensor box according to an embodiment of the present invention, as well as the configuration of the flow path flowing on the biosensor.

[0067] Figure 16 and Figure 17 This is a diagram illustrating the process of opening and closing the sensor cover in a biosensor box according to an embodiment of the present invention.

[0068] Figure 18 This is an exploded perspective view illustrating the valve and pump sections in a biosensor box according to an embodiment of the present invention.

[0069] Figure 19 This is an exploded perspective view illustrating the valve section in a biosensor box according to an embodiment of the present invention.

[0070] Figure 20 This is a perspective view illustrating the channel plate of the valve section in a biosensor box according to an embodiment of the present invention.

[0071] Figure 21 This is a bottom view used to illustrate the pump section in a biosensor box according to an embodiment of the present invention.

[0072] Figure 22 This is a diagram illustrating the process of tube compression along the rotation of the pump section in a biosensor box according to an embodiment of the present invention.

[0073] Figure 23 This is a diagram illustrating the process of introducing a buffer solution into a biosensor cartridge as the buffer blister is broken, according to an embodiment of the present invention.

[0074] Figure 24 This is a diagram illustrating the process of adding a sample solution to a biosensor cartridge according to an embodiment of the present invention.

[0075] Figure 25 This is a perspective view illustrating the state in which a biosensor cartridge of one embodiment of the present invention is inserted into a diagnostic device.

[0076] Figure 26 This is a perspective view illustrating the internal structure of a diagnostic device according to an embodiment of the present invention.

[0077] Figure 27 This is a diagram illustrating the actuator in a diagnostic device according to an embodiment of the present invention.

[0078] Figure 28 This is a diagram illustrating the structure for aligning actuators in a diagnostic apparatus according to an embodiment of the present invention.

[0079] Figure 29 This is a diagram illustrating the process of an actuator descending and combining with a biosensor box in a diagnostic device according to an embodiment of the present invention.

[0080] Figure 30 This is a diagram illustrating the process of aligning the position of the valve section by rotating the actuator in a diagnostic device according to an embodiment of the present invention.

[0081] Figure 31a This is a diagram illustrating the rotation of the valve section during the pre-loading step in a biosensor box and diagnostic device according to an embodiment of the present invention.

[0082] Figure 31b This is a diagram illustrating the flow of sample solution in the pre-loading step of a biosensor box and diagnostic device according to an embodiment of the present invention.

[0083] Figure 32a This is a diagram illustrating the rotation of the valve in the buffer solution circulation step of a biosensor box and diagnostic device according to an embodiment of the present invention.

[0084] Figure 32b This is a diagram illustrating the flow of the buffer solution in the buffer solution circulation step of a biosensor box and diagnostic device according to an embodiment of the present invention.

[0085] Figure 33a This is a diagram illustrating the rotation of the valve in the sample solution circulation step of a biosensor box and diagnostic device according to an embodiment of the present invention.

[0086] Figure 33bThis diagram illustrates the flow of the sample solution in the sample solution circulation step of a biosensor box and diagnostic device according to an embodiment of the present invention.

[0087] Figure 34 This is a block diagram illustrating the control relationships in a biosensor box and diagnostic device according to an embodiment of the present invention.

[0088] Figure 35 This is a sequence diagram illustrating a control method for a diagnostic device according to an embodiment of the present invention. Detailed Implementation

[0089] The preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0090] This invention can have various modifications and embodiments, with specific embodiments illustrated in the accompanying drawings and detailed descriptions provided. This invention is not limited to specific embodiments, but includes all modifications, equivalents, and substitutions falling within the scope of the invention's concept and technology.

[0091] In describing this invention, terms such as "first" and "second" are used to describe various constituent elements, but these terms do not limit the constituent elements. These terms are only used to distinguish one constituent element from others. For example, without departing from the scope of this invention, a first constituent element may be named a second constituent element, and similarly, a second constituent element may be named a first constituent element.

[0092] The term “and / or” can include a combination of multiple related items or any one of multiple related recorded items.

[0093] When a constituent element is mentioned as being "connected" or "linked" to other constituent elements, it can be understood either as being directly connected or linked to other constituent elements, or as having other constituent elements in between. Conversely, when a constituent element is mentioned as being "directly connected" or "directly linked" to other constituent elements, it can be understood as having no other constituent elements in between.

[0094] The terminology used in this application is for illustrative purposes only and is not intended to limit the scope of the invention. Unless otherwise specified herein, singular expressions include plural meanings.

[0095] In this application, terms such as "comprising" or "having" refer to the presence of features, figures, steps, actions, constituent elements, components, or combinations thereof as described in the specification, and do not preclude the existence or possibility of one or more other features or figures, steps, actions, constituent elements, components, or combinations thereof.

[0096] Unless otherwise defined herein, all terms used herein, including technical or scientific terms, shall have the same meaning as understood by a person skilled in the art in the ordinary sense. Predefined terms used in the ordinary sense shall be understood to have the same meaning as understood in the relevant art text, and shall not be construed as having an ideal or overly formal meaning unless explicitly defined in this application.

[0097] Furthermore, the following embodiments are provided to illustrate the invention more fully to those skilled in the art. For clarity, the shapes and sizes of the elements in the accompanying drawings may be exaggerated.

[0098] Figure 1 The diagram illustrates a biosensor box and diagnostic device according to an embodiment of the present invention. Figures 2 to 4 A diagram is shown illustrating a biosensor cartridge for illustrating one embodiment of the present invention. Figure 5 Showing the use of Figure 4 A top view illustrating the state of the upper shell removed.

[0099] For reference, in this invention, target materials, referring to biological substances representing specific substrates, can be interpreted as having the same meaning as analytes. In this invention, probe materials, referring to biological substances that specifically bind to target materials, can be interpreted as having the same meaning as receptors or acceptors. In this embodiment, biological substances can be antigens, antibodies, DNA, low-molecular-weight organic compounds, proteins, peptides, amino acids, ligand proteins, etc.

[0100] Reference Figures 1 to 5 The biosensor box 1 of one embodiment of the present invention is described below.

[0101] One embodiment of the biosensor system of the present invention includes a biosensor box 1 and a diagnostic device 2. The biosensor box 1, in one embodiment of the present invention, is integrated with the diagnostic device 2 to sense biological substances, thereby enabling the diagnosis of diseases, etc.

[0102] At this time, the biosensor cartridge 1 of the present invention is inserted into the diagnostic device 2 in a horizontally arranged state. In addition, the biosensor cartridge 1 allows the buffer solution and sample solution to flow inside, and causes the biosensor 400 to generate an electrochemical reaction with the biological material, and the resulting electrical change can be transmitted to the diagnostic device 2 through the printed circuit board 500.

[0103] Specifically, the biosensor box 1 includes a housing 100, a frame 200, a canister 300, a biosensor 400, a printed circuit board 500, a channel 600, a tube 700, a valve section 800, and a pump section 900.

[0104] At this time, a frame 200 is housed inside the outer casing 100, a can 300 is formed on the upper side of the frame 200, and a channel 600 is formed inside the frame 200. In addition, a tube 700, a valve section 800, and a pump section 900 are combined in the frame 200, and a biosensor 400 and a printed circuit board 500 are detachably combined in the frame 200.

[0105] For reference, in this invention, with frame 200 as a reference, the direction in which the buffer solution is immersed is called the upper side, and with frame 200 as a reference, the opposite direction of the upper side is called the lower side. Additionally, the direction in which the biosensor cartridge 1 is inserted into the diagnostic device 2 can be called the front. That is, the direction in which the printed circuit board 500 is disposed relative to the housing 100 can be called the front. Furthermore, the opposite direction of the front can be called the rear. Additionally, when viewing the front from the rear end of the housing 100, the direction disposed on the left can be called the left side, and the direction disposed on the right can be called the right side.

[0106] The outer shell 100 forms the shape of the biosensor box 1, and can house the frame 200, the can 300, the biosensor 400, the printed circuit board 500, the channel 600, the tube 700, the valve 800 and the pump 900 inside.

[0107] The outer casing 100 includes an upper outer casing 110 and a lower outer casing 120.

[0108] For example, the upper outer shell 110 is formed as a four-cornered box with the lower side open, and a buffer solution inlet hole 111, a sample solution inlet hole 112, a valve connection hole 113 and a pump connection hole 114 can be formed on the upper surface.

[0109] The buffer solution inlet 111 can be formed to allow the buffer solution to flow into it. The buffer solution inlet 111 can also be formed in the blister packing tank 111a. In this case, the blister packing tank 111a can be positioned vertically at the upper part of the buffer solution tank 310. Therefore, the buffer solution inlet 111 can also be positioned vertically at the upper side of the buffer solution tank 310, and the buffer solution inlet 111 can be formed to communicate with the internal space of the buffer solution tank 310.

[0110] The blister pack 3 can be attached to the blister pack storage groove 111a. The blister pack storage groove 111a is formed by a downward recess on the upper surface of the upper outer shell 110, corresponding to the shape of the blister pack 3. For example, the blister pack storage groove 111a is formed in the shape of a square groove or a circular groove on the upper surface of the upper outer shell 110. In addition, at least one blister pack piercing portion 111d is formed protrudingly in the blister pack storage groove 111a to pierce the blister pack 3. At this time, the blister pack piercing portion 111d is arranged in a circumferential direction with the buffer solution inlet hole 111 as the origin.

[0111] With this structure, when the buffer blister 3 is housed inside the blister storage tank 111a and pressurized, the blister 3 is broken open by the blister puncture part 111d, thereby allowing the buffer solution to flow into the buffer solution tank 310 through the buffer solution inlet hole 111.

[0112] On the other hand, according to an embodiment, at least one or more vent holes 111b and 116 may be formed on the upper surface of the upper housing 110. The vent holes 111b and 116 can exhaust air from the interior of the housing 100 to the outside.

[0113] Specifically, a first vent 111b can be formed on the upper surface of the upper outer casing 110. The first vent 111b can be positioned vertically at the upper part of the buffer solution tank 310. Therefore, the first vent 111b can be configured to communicate with the internal space of the buffer solution tank 310. With this structure, when the buffer solution flows into the buffer solution tank 310, air inside the buffer solution tank 310 can be discharged to the outside through the first vent 111b. Therefore, it has the advantage of preventing an increase in internal air pressure within the buffer solution tank 310 and reducing the probability of air being mixed into the buffer solution.

[0114] Additionally, according to the embodiment, a first air passage 111c may be formed on the upper surface of the upper housing 110. The first air passage 111c is formed to communicate with the first vent 111b and can be formed in the shape of a groove along the upper surface of the upper housing 110. At this time, the air passage 111c can be formed as a straight groove or as a shape that bends multiple times on the upper surface of the upper housing 110. This is to ensure the maximum flow path length within a limited area. With such a structure, when the label 130 is adhered to the upper surface of the upper housing 110, the first air passage 111c forms a space between the upper housing 110 and the label 130 and can collect the air discharged through the first vent 111b.

[0115] The sample solution inlet hole 112 is configured to allow sample solution to flow into it. The sample solution inlet hole 112 is positioned vertically on the upper side of the sample solution container 320. Therefore, the sample solution inlet hole 112 communicates with the internal space of the sample solution container 320. On the other hand, a stopper 112a is detachably attached to the sample solution inlet hole 112. Therefore, when the stopper 112a is attached, the sample solution inlet hole 112 can be blocked. Furthermore, when the stopper 112a is removed, the sample solution inlet hole 112 is opened, allowing sample solution to be added. On the other hand, after adding sample solution, blocking the sample solution inlet hole 112 with the stopper 112a prevents foreign matter from entering the sample solution inlet hole 112.

[0116] The valve connection hole 113 can be formed such that a portion of the valve portion 800 passes through it. The valve connection hole 113 can be disposed on the upper side of the valve joint portion 223. In this case, the valve connection hole 113 is formed into a circular hole shape, and the valve knob 820 can be disposed through the valve connection hole 113. Furthermore, the valve knob 820 can rotate within the valve connection hole 113.

[0117] The pump connection hole 114 can be formed so that a portion of the pump section 900 passes through it. The pump connection hole 114 can be disposed on the upper side of the valve connection portion 223. Specifically, the pump connection hole 114 can be disposed on the upper side of the pump receiving groove 222a. In this case, the pump connection hole 114 is formed into a circular hole shape, and the pump knob 910 can be disposed to pass through the valve connection hole 113. Furthermore, the pump knob 910 can rotate within the pump connection hole 114.

[0118] On the other hand, a support protrusion 115 for supporting the printed circuit board 500 is formed on the upper surface of the upper housing 110, protruding inward toward the housing 100. The support protrusion 115 can be disposed on the vertical upper side of the substrate joint portion 221 of the frame 200. The support protrusion 115 contacts the upper surface of the printed circuit board 500 and can support the printed circuit board 500.

[0119] On the other hand, according to the embodiment, a second vent 116 is also formed on the upper surface of the upper outer casing 110. In this case, the second vent 116 can be disposed vertically at the upper part of the waste solution tank 330. Therefore, the second vent 116 can be configured to communicate with the internal space of the waste solution tank 330. With this structure, when the buffer solution or sample solution flows into the waste solution tank 330, the air inside the waste solution tank 330 can be discharged to the outside through the second vent 116. Therefore, it is possible to prevent the internal air pressure of the waste solution tank 330 from rising.

[0120] Furthermore, according to the embodiment, a second air passage 116a is formed on the upper surface of the upper housing 110. The second air passage 116a is formed to communicate with the second vent 116 and is formed in the shape of a groove along the upper surface of the upper housing 110. At this time, the second air passage 116a can not only be formed as a straight groove, but also as a shape that bends multiple times on the upper surface of the upper housing 110. This is to ensure the maximum flow path length within a limited area. With such a structure, when the label 130 is adhered to the upper surface of the upper housing 110, the second air passage 116a forms a space between the upper housing 110 and the label 130 to accommodate the air discharged through the second vent 116.

[0121] The lower outer shell 120 is combined with the upper outer shell 110 to form a space inside that can accommodate the frame 200, the tank 300, the biosensor 400, the printed circuit board 500, the channel 600, the tube 700, the valve section 800, and the pump section 900.

[0122] For example, the lower outer shell 120 is formed as a four-cornered box with an open upper side, so that it can be combined with the upper outer shell 120. At this time, on the side wall of the lower outer shell 120, a plurality of hooks are formed protruding toward the upper outer shell 110 and are engaged with grooves (not shown) formed on the side wall of the upper outer shell 110.

[0123] At this point, welding or bonding can be performed on the edge attachment areas of the upper housing 110 and the lower housing 120 to further strengthen the attachment between them. Such welding can be performed by ultrasonic welding, but is not limited to this, and can be achieved by additional bonding components. This prevents moisture or foreign matter from penetrating into the interior from the outside.

[0124] On the other hand, a sensor insertion hole 121 for inserting a biosensor 400 may be formed on the lower surface of the lower housing 120. In this case, the diameter of the sensor insertion hole 121 may be larger than the diameter of the sensor coupling portion 211 described later. For example, the sensor insertion hole 121 may be formed in a circular hole shape, and a pair of cap coupling portions 121a may be formed radially inward on at least a portion of the sidewall surrounding the sensor insertion hole 121. The cap coupling portions 121a can be supported by engaging with the hooks 122a of the sensor cap 122.

[0125] Furthermore, a sensor cover 122 can be attached to the lower surface of the lower housing 120. The sensor cover 122 can cover the sensor insertion hole 121 and prevent the biosensor 400 attached to the frame 200 from detaching.

[0126] The sensor cover 122 includes a hook 122a, a sensor support portion 122b, and a connecting guide groove 122c. For example, the sensor cover 122 is generally formed in a disk shape, with the hook 122a and sensor support portion 122b protruding from the upper surface of the sensor cover 122, and the connecting guide groove 122c recessed from the lower surface of the sensor cover 122. In this case, the diameter of the sensor cover 122 can be formed to correspond to the diameter of the sensor insertion hole 121. For example, the diameter of the sensor cover 122 can be formed to be the same as the diameter of the sensor insertion hole 121.

[0127] Hooks 122a are formed protruding upwards from the upper surface of the sensor cover 122, with their upper ends protruding radially outwards. For example, a pair of hooks 122a are formed in opposite positions and at a predetermined angle along the circumferential direction. With this structure, after the hooks 122a are inserted into the sensor insertion hole 121 where the cover joint 121a is not formed, they can be positioned on the upper side of the cover joint 121a when the sensor cover 122 is rotated. Therefore, by positioning the cover joint 121a between the hooks 122a and the upper surface of the sensor cover 122, the sensor cover 122 can be prevented from detaching.

[0128] The sensor support portion 122b is formed protruding upward along the circumferential direction on the upper surface of the sensor cover 122. For example, the sensor support portion 122b may be formed as a circular rib with the radial center of the sensor cover 122 as the origin. The sensor support portion 122b may be formed in such a way that it contacts and supports the lower surface of the biosensor 400. Therefore, when the sensor cover 122 is attached to the lower housing 120 and blocks the sensor insertion hole 121, the sensor support portion 122b can contact and support the biosensor 400. This prevents the biosensor 400 from shaking, thereby preventing errors in the measurement values ​​of the biosensor 400.

[0129] On the other hand, refer to Figure 16 and Figure 17The illustration shows the process of the sensor cover 122 being fixed by engaging with the sensor insertion hole 121. At this time, a cover engagement guide 123 is provided on the lower housing 120, and an engagement guide groove 122c is formed on the lower surface of the sensor cover 122. The cover engagement guide 123 is configured to allow the user to visually identify whether the sensor cover 122 is in a fixed state or a detachable state. For example, the cover engagement guide 123 is formed radially outward of the sensor insertion hole 121, and unlocking markings 123a and locking markings 123b are arranged at predetermined intervals along the circumferential direction. The cover engagement portion 121a can be arranged radially inward of the locking marking 123b. Furthermore, the engagement guide groove 122c can be formed in the shape of a rectangular groove on the lower surface of the sensor cover 122. A hook 122a can be arranged along the long axis (length direction) of the engagement guide groove 122c. Therefore, the user can separate the sensor cover 122 and the lower housing 120 by aligning the extension line of the guide groove 122c in the longitudinal direction with the unlock mark 123a. Alternatively, with the sensor cover 122 blocking the sensor insertion hole 121, the sensor cover 122 can be rotated with the extension line of the guide groove 122c in the longitudinal direction aligning with the locking mark 123b to lock the sensor cover 122 in the engaged state.

[0130] With this structure, users can easily attach the sensor cover 122 and intuitively identify and execute methods to lock or unlock the attachment state.

[0131] Therefore, according to the present invention, even users with low proficiency can easily assemble and disassemble the biosensor 400 from the biosensor box 1.

[0132] On the other hand, a label 130 may be attached to the outer casing 100. The label 130 may be attached to the upper surface of the upper casing 110. Information about the biosensor cartridge 1 may be displayed on the label 130. For example, the label 130 may display information such as the manufacturer's name, the location for adding the buffer solution, the location for adding the sample solution, and the direction for inserting the diagnostic device 2.

[0133] With this structure, even users with low proficiency can easily use the biosensor box 1.

[0134] Additionally, a QR code (Quick Response Code) can be displayed on label 130. This QR code stores sensor information, including the product ID and manufacturing serial number used for genuine product authentication. The QR code can include all sensor information used for genuine product authentication. For example, it may include not only the product ID and manufacturing serial number, but also biosensor information and cartridge information. The biosensor information may include the sensing substance activated in the biosensor 400, the disease to be diagnosed, the biosensor manufacturing date, manufacturing location, and manufacturing serial number. The cartridge information may include the assembly date, inspection date, shelf life, and sensor ID of the biosensor cartridge 1. The stored QR code is read from the QR reading module of the diagnostic device 2 and the genuine product authentication process is performed via a cloud server. Through this authentication step, errors can be identified, including those indicating a danger to the current type of biosensor cartridge 1.

[0135] on the other hand, Figure 6 An exploded perspective view is shown to illustrate a framework for one embodiment of the present invention. Figure 7 A top view is shown to illustrate the upper frame of one embodiment of the invention. Figure 8 A cross-sectional view of a frame according to an embodiment of the present invention is shown.

[0136] Reference Figures 6 to 8 The frame 200 and the can 300 formed on the frame of a biosensor box 1 according to an embodiment of the present invention are described below.

[0137] The frame 200 is disposed inside the housing 100, and channels 600 for the flow of buffer solution and sample solution are formed therein. In addition, the biosensor 400 and the printed circuit board 500 can be detachably attached to the frame 200, so that the biosensor 400 can detect biological substances in the sample solution flowing in the channels 600.

[0138] The frame 200 includes a bottom frame 210, an upper frame 220, a hydrophilic adhesive layer 230, and a micro-flow path forming adhesive layer 240. The hydrophilic adhesive layer 230 is stacked on the upper side of the bottom frame 210, the micro-flow path forming adhesive layer 240 is stacked on the upper side of the hydrophilic adhesive layer 230, and the upper frame 220 can be stacked on the upper side of the micro-flow path forming adhesive layer 240.

[0139] The biosensor 400 can be detachably attached to the bottom frame 210. The bottom frame 210 is attached to the biosensor 400 and can support the biosensor 400. For example, the bottom frame 210 can be formed in the shape of a generally four-cornered flat plate, and can be formed with a sensor attachment 211 for attaching to the biosensor 400.

[0140] The sensor connector 211 can be positioned opposite the sensor insertion hole 121. Specifically, the sensor connector 211 can be positioned vertically above the sensor insertion hole 121. In this case, the sensor connector 211 can have a diameter smaller than the diameter of the sensor insertion hole 121. Thus, the biosensor 400 can be separated or connected through the sensor insertion hole 121.

[0141] The sensor connector 211 can be detachably coupled to the biosensor 400. The sensor connector 211 is generally formed with a hole shape corresponding to the shape of the biosensor 400, and may have a frame extending transversely through the hole along its minor axis. A pair of ports 631 and 632 may be formed in the frame. For example, the sensor connector 211 may be formed with a quadrangular hole, and its diameter in the front-back direction and its diameter in the left-right direction may be the same as the length in the front-back direction and the width in the left-right direction of the biosensor 400.

[0142] Therefore, the biosensor 400 can be fitted into the sensor junction 211. Furthermore, at least a portion of the sidewall surrounding the sensor junction 211 can be greater than the thickness of the biosensor 400. Therefore, with the biosensor 400 fitted into the sensor junction 211, the biosensor 400 can be stably supported.

[0143] On the other hand, holes for fixing the valve section 800 and the pump section 900 can be formed in the bottom frame 210. Fixing components such as screws pass through the holes and can be connected to the valve section 800 and the pump section 900 disposed on the upper side of the upper frame 210.

[0144] A can 300 may be formed on the upper frame 220. Specifically, a can 300 may be formed on the upper surface of the upper frame 220. The can 300 will be described later.

[0145] A channel 600 may be formed in the upper frame 220. Specifically, a channel 600 may be formed on the lower surface of the upper frame 220. The channel 600 will be described later.

[0146] At this point, the upper frame 220 can be formed of a resin material. For example, the upper frame 220 can be formed of PMMA (Polymethyl methacrylate) resin. This allows for the formation of fine channels 600 through injection molding and enables mass production. Simultaneously, the upper frame 220 and the bottom frame 210 can be easily bonded together using a tape.

[0147] A substrate bonding portion 221 can be formed on the upper surface of the upper frame 220. A printed circuit board 500 is detachably bonded to the substrate bonding portion 221. A sensor bonding portion 211 can be disposed on one side of the frame 200, and the substrate bonding portion 221 can be disposed on the other side of the frame 200. In this case, the substrate bonding portion 221 can be positioned opposite the sensor bonding portion 211, separated from the frame 200. Specifically, at least a portion of the substrate bonding portion 221 can be disposed on the upper side of the sensor bonding portion 211. With this structure, the distance between the biosensor 400 and the printed circuit board 500 can be minimized. Therefore, the information sensed by the biosensor 400 can be transmitted to the printed circuit board 500 quickly and accurately.

[0148] The substrate bonding portion 221 may include bonding guide portions 221a for guiding the sliding bonding of the printed circuit board 500. The bonding guide portions 221a are formed by protruding upwards from the upper surface of the upper frame 220, forming a pair relative to each other, and then bending and extending in opposite directions. In this case, the spacing between the pair of bonding guide portions 221a may be the same as the width of the printed circuit board 500. Therefore, the pair of bonding guide portions 221a can stably support the printed circuit board 500 and prevent the printed circuit board 500 from wobbling in the horizontal direction. Furthermore, the protrusion height of the pair of bonding guide portions 221a is the same as or slightly greater than the thickness of the printed circuit board 500. This prevents the printed circuit board 500 from moving in the vertical direction.

[0149] Additionally, the substrate bonding portion 221 may also include a substrate support portion 221b that guides the bonding position of the printed circuit board 500 and supports the printed circuit board 500. A pair of opposing substrate support portions 221b are formed protruding upwards from the upper surface of the upper frame 220. In this case, the substrate support portions 221b may be formed corresponding to the shape of the two ends in the width direction (minor axis direction) of the printed circuit board 500. For example, if semi-circular grooves are formed at both ends in the width direction of the printed circuit board 500, the pair of substrate support portions 221b may be formed in a semi-circular protrusion towards each other. Furthermore, the shortest distance between the pair of substrate support portions 221b may be the same as the shortest distance in the width direction of the printed circuit board 500. Thus, when the printed circuit board 500 is bonded, it is fitted with the substrate support portions 221b to guide the bonding position, preventing the printed circuit board 500 from moving along the insertion direction.

[0150] As a result, the substrate bonding portion 221 can prevent the printed circuit board 500, which is bonded by the bonding guide portion 221a and the substrate support portion 221b, from wobbling in the horizontal and vertical directions.

[0151] Therefore, the following effect is achieved: the substrate bonding portion 221 stably supports the bonded printed circuit board 500, thereby preventing the printed circuit board 500 from shaking and causing data errors.

[0152] Additionally, a clamping hole 221c for receiving the contact clip 450 can be formed in the substrate bonding portion 221. A pair of clamping holes 221c can be disposed on the substrate bonding portion 221. At this time, at least a portion of one of the clamping holes 221c can be disposed between a pair of bonding guide portions 221a. In addition, at least a portion of the other clamping hole 221c can be disposed between a pair of substrate support portions 221b.

[0153] This prevents the contact clip 450, which is housed in the clip storage hole 221c, from falling out of its designated position.

[0154] Additionally, a pair of clip receiving holes 221c may be configured to communicate with the sensor coupling portion 211. In this case, at least a portion of each of the pair of clip receiving holes 221c may be positioned opposite to the sensor coupling portion 211. For example, the sensor coupling portion 211 may be positioned between the pair of clip receiving holes 221c, and portions of both ends of the sensor coupling portion 211 in the longitudinal direction (front-back direction) may overlap with at least a portion of each of the pair of clip receiving holes 221c.

[0155] With this structure, a step for attaching the contact clip 450 can be formed when the bottom frame 210 and the upper frame 220 are stacked. Furthermore, the contact clip 450 itself can directly contact the biosensor 400 and the printed circuit board 500. As a result, the biosensor cartridge 1 of the present invention can improve the accuracy of data transmission via the contact clip 450.

[0156] On the other hand, a tube storage section 222 may be formed in the upper frame 220. The tube storage section 222 is formed protruding upward on the upper surface of the upper frame 220. The tube storage section 222 can guide the arrangement position of the tube 700 on the upper frame 220.

[0157] Specifically, the pipe receiving section 222 is formed in a block shape on the upper surface of the upper frame 220, and a pump receiving groove 222a and a pipe guiding groove 222b can be formed inside it.

[0158] The pump receiving groove 222a can internally accommodate at least a portion of the tube 700 and the pump section 900. In this case, the tube 700 is arranged circumferentially, and at least a portion of the pump section 900 can be rotatably housed inside the wound tube 700. Furthermore, at least a portion of the pump section 900 can be arranged in contact with the tube 700 within the pump receiving groove 222a. For example, the pump receiving groove 222a is formed in a circular groove shape, the tube 700 is wound along its inner circumferential surface, and the pump section 900 can be rotatably arranged inside the tube 700.

[0159] With this structure, when the pump section 900 rotates, the pipe 700 disposed between the side wall of the pump receiving groove 222a and the pump section 900 can be squeezed.

[0160] The pipe guide groove 222b is configured to communicate with the pump receiving groove 222a and can receive at least a portion of the pipe 700. Specifically, one side and the other side of the wound pipe 700 at the pump receiving groove 222a can be received in the pipe guide groove 222b respectively. At this time, one side and the other side of the pipe 700 are received in the pipe guide groove 222b in a crisscrossing manner. That is, the groove for receiving one side of the pipe 700 and the groove for receiving the other side of the pipe 700 merge into one, and the merging point 222c can communicate with the pump receiving groove 222a.

[0161] Therefore, when the pump section 900 rotates, at least a portion of the pipe 700 can remain in contact with the pump section 900. Thus, when the pump section 900 rotates, backflow in the solution flowing in the pipe 700 can be prevented.

[0162] On the other hand, a valve engagement portion 223 may be formed on the upper frame 220. The valve engagement portion 223 may be formed protruding upward on the upper surface of the upper frame 220. For example, the valve engagement portion 223 may be formed protruding in the form of a rib on the upper surface of the upper frame 220. The valve engagement portion 223 may be formed to surround at least a portion of the outer side of the valve portion 800. Therefore, the valve engagement portion 223 may guide the engagement position of the valve portion 800.

[0163] On the other hand, multiple ports may be formed in the upper frame 220. These ports provide space for the buffer solution or sample solution to flow into the channel 600 or to drain from the channel 600. Specifically, the upper frame 220 may have a buffer solution inflow port 315, a buffer solution port 615, a sample solution port 625, a sensing port 635, a pre-filling port 645, a waste solution port 655, a first tube connection port 660, and a second tube connection port 670.

[0164] At this time, the buffer solution inlet port 315 is disposed inside the buffer solution tank 310 so that the buffer solution in the buffer solution tank 310 flows into the channel 600.

[0165] Furthermore, the buffer solution port 615, sample solution port 625, sensing port 635, and pre-filling port 645 are configured to be connected via the valve section 800. For example, the buffer solution port 615, sample solution port 625, and pre-filling port 645 can be arranged on concentric circles with the sensing port 635 as the origin. In this case, the buffer solution port 615, sample solution port 625, and pre-filling port 645 are arranged with a predetermined angular difference relative to the sensing port 635 as the origin.

[0166] Furthermore, the first pipe connection port 660 and the second pipe connection port 670 can be configured to connect to the pipe 700. In this case, the first pipe connection port 660 and the second pipe connection port 670 are arranged adjacent to the pump section 900. For example, the second pipe connection port 670 is arranged on one side of the upper frame 220 along the length direction with reference to the pump section 900, and the first pipe connection port 660 is arranged on the other side of the upper frame 220 along the length direction with reference to the pump section 900.

[0167] On the other hand, in the case of conventional biosensor boxes, channels are formed inside the frame to allow liquid to flow, but the accuracy of the sensing decreases each time a sample solution is tested because the flow rate of the solution is not constant.

[0168] To address this issue, a hydrophilic coating is sometimes applied to the bottom frame. However, this increases production costs due to the added coating process and also has the drawback of increasing the defect rate due to uneven coating.

[0169] Therefore, in this invention, the flow rate of the solution is kept constant by means of the hydrophilic adhesive layer 230, while the rate of increase in production costs and the rate of defective products are minimized.

[0170] A hydrophilic adhesive layer 230 may be disposed between the bottom frame 210 and the upper frame 220. The hydrophilic adhesive layer 230 may also be disposed between the bottom frame 210 and the micro-flow path forming adhesive layer 240. For example, the hydrophilic adhesive layer 230 may be a hydrophilic tape or a hydrophilic film. The hydrophilic adhesive layer 230 is disposed on the upper side of the bottom frame 210 to facilitate the flow of fluid in the channel 600. Therefore, it has the effect that the flow rate of the solution can be stably maintained by the hydrophilic adhesive layer 230.

[0171] In addition, it also has the following advantages: even during the manufacturing process, bonding can be performed by a simple process of placing a hydrophilic adhesive layer 230 on the upper side of the bottom frame 210 and forming an adhesive layer 240 and an upper frame 220 under pressure without the need for additional heating steps.

[0172] The hydrophilic adhesive layer 230 may be formed in a shape corresponding to that of the upper frame 220. For example, a clamping hole 231 may be formed in the hydrophilic adhesive layer 230. The clamping hole 231 of the hydrophilic adhesive layer 230 may be formed at a position opposite to the clamping hole 221c of the upper frame 220, and may be formed in the same size and shape.

[0173] Additionally, the hydrophilic adhesive layer 230 can be formed into a shape corresponding to the shape of the bottom frame 210. For example, ports can be formed in the hydrophilic adhesive layer 230. The ports of the hydrophilic adhesive layer 230 can be formed at positions opposite to the ports 631a and 632a of the bottom frame 210, and can be formed into the same size shape.

[0174] The micro-flow path forming adhesive layer 240 can be disposed between the hydrophilic adhesive layer 230 and the upper frame 220. The micro-flow path forming adhesive layer 240 can bond the hydrophilic adhesive layer 230 and the upper frame 220. At this time, the micro-flow path forming adhesive layer 240 can be formed into a shape corresponding to the shape of the upper frame 220.

[0175] Specifically, the micro-flow path forming adhesive layer 240 may have channel gaps 242 communicating with the channels 600 formed on the upper frame 220. The channel gaps 242 may be formed at a position opposite to the channels 600. In this case, the width of the channel gaps 242 may be greater than the width of the channels 600. With this structure, even if there are errors in the positions of the channels 600 and the channel gaps 242, errors in the flow of the solution can be prevented.

[0176] Additionally, a receiving hole 241 may be formed in the adhesive layer 240 formed in the microflow path. The receiving hole 241 of the adhesive layer 240 formed in the microflow path is formed at a position opposite to the receiving hole 221c of the upper frame 220, and may be formed in the same size shape.

[0177] The container 300 is formed on the upper surface of the frame 200 and provides space for receiving buffer solutions and / or sample solutions. For example, the container 300 may be formed in a shape that protrudes from the upper surface of the upper frame 220 and surrounds a defined space.

[0178] Tank 300 may include buffer solution tank 310. Buffer solution flows into buffer solution tank 310, which at least temporarily holds the buffer solution, allowing the buffer solution to flow to channel 600.

[0179] The buffer solution tank 310 can be disposed on the rear side (one side in the length direction) of the frame 200. The buffer solution tank 310 can also be disposed on the opposite side of the substrate joint 221 on the frame 200.

[0180] Additionally, the buffer solution tank 310 can be configured on the left side (one side in the short axis direction) of the frame 200. The buffer solution tank 310 can also be configured on the frame 200 on the opposite side of the waste solution tank 330.

[0181] The buffer solution tank 310 is formed as a wall protruding from the upper surface of the upper frame 220. For example, the buffer solution tank 310 is formed as a four-cornered wall. A buffer solution inlet port 315 can be formed in the upper frame 220, and the buffer solution inlet port 315 can be configured to communicate with the buffer solution channel 610. The buffer solution inlet port 315 can be formed inside the buffer solution tank 310. Furthermore, an inclined surface 311 and a guide groove can be formed inside the buffer solution tank 310 to guide the buffer solution flow to the buffer solution inlet port 315. For example, the inclined surface is formed to slope downwards from the rear end of the buffer solution tank 310 towards the front. Simultaneously, the inclined surface is formed to slope downwards from both sides of the buffer solution tank 310 towards the center in the left-right direction. Therefore, a guide groove can be formed on the inner bottom surface of the buffer solution tank 310 along the front-rear direction. And the buffer solution inlet port 315 can be formed on the guide groove.

[0182] Therefore, the buffer solution tank 310 can surround the space in which the buffer solution flows. Thus, the buffer solution can be contained in the buffer solution tank 310, and can be discharged into the channel 600 as the pump unit 900 operates.

[0183] The container 300 may include a sample solution container 320. The sample solution is flowed into the sample solution container 320, which at least temporarily holds the sample solution, allowing the sample solution to flow into the channel 600.

[0184] The sample solution container 320 can be disposed on the rear side of the frame 200. The sample solution container 320 can also be disposed on the opposite side of the substrate bonding portion 221 on the frame 200.

[0185] Additionally, at least a portion of the sample solution container 320 may be disposed in the central part of the frame 200 in the left-right direction. The sample solution container 320 may be disposed between the buffer solution container 310 and the waste solution container 330.

[0186] The sample solution container 320 is formed protrudingly as a wall on the upper surface of the upper frame 220. For example, the sample solution container 320 is formed protruding as a circular wall. In this case, the upper frame 220 may be configured such that at least a portion of the lower side of the internal space of the sample solution container 320 is open. The internal space of the sample solution container 320 may be configured to communicate with the sample solution channel 620.

[0187] Therefore, the sample solution container 320 can surround the space in which the sample solution flows. Thus, the sample solution can be contained in the sample solution container 320, and can be discharged into the channel 600 when the pump unit 900 is operated.

[0188] Tank 300 may include waste solution tank 330. Waste solution may flow into waste solution tank 330 for storage.

[0189] The waste solution tank 330 can be disposed on the rear side of the frame 200. The waste solution tank 330 can also be disposed on the opposite side of the substrate joint 221 on the frame 200.

[0190] Additionally, the waste solution tank 330 can be configured on the right side of the frame 200.

[0191] The waste solution tank 330 is formed protrudingly as a wall on the upper surface of the upper frame 220. For example, the waste solution tank 330 is formed as a four-cornered wall. In this case, a waste solution port 655 may be formed in the upper frame 220, and the waste solution port 655 may be configured to communicate with the waste solution channel 650. The waste solution port 655 may be formed inside the waste solution tank 330.

[0192] Therefore, the waste solution tank 330 surrounds the space in which the waste solution flows. Thus, with the operation of the pump unit 900, the waste solution can flow from the channel 600 into the waste solution tank 330 for storage.

[0193] on the other hand, Figure 9 A bottom view is shown to illustrate a channel formed on the upper frame of an embodiment of the present invention.

[0194] Reference Figure 9 The channel 600 of the biosensor box 1 according to one embodiment of the present invention is described below.

[0195] Channel 600 may be formed inside frame 200 to provide a flow path for buffer solution or sample solution. Specifically, channel 600 may be formed on the lower surface of upper frame 220.

[0196] Channel 600 includes a buffer solution channel 610 connected to the buffer solution tank 310 and for the flow of buffer solution. Specifically, one side of the buffer solution channel 610 is connected to the buffer solution inlet port 315. Therefore, one side of the buffer solution channel 610 is connected to the internal space of the buffer solution tank 310 through the buffer solution inlet port 315. Additionally, the other side of the buffer solution channel 610 is connected to the buffer solution port 615. With the operation of the valve section 800, the other side of the buffer solution channel 610 can be connected to the sensing channel 630 through the buffer solution port 615.

[0197] The buffer solution channel 610 guides the buffer solution flowing into the buffer solution tank 310 to the valve section 800. For example, the buffer solution channel 610 may be formed along the length direction (major axis direction) of the frame 200. In this case, according to the embodiment, the buffer solution channel 610 may be formed in a shape that bends at least once at a predetermined angle. For example, the buffer solution channel 610 is formed entirely along the length direction (major axis direction) of the frame 200 and is formed with a portion that bends twice.

[0198] On the other hand, the buffer solution inlet port 315 can serve as the inlet of the buffer solution channel 610, and the buffer solution outlet port 615 can serve as the outlet of the buffer solution channel 610.

[0199] At this time, the buffer solution channel 610 can be configured such that the width of the inlet side and the width of the outlet side are different. For example, the width of the outlet side of the buffer solution channel 610 can be configured such that the width of the outlet side is greater than the width of the inlet side. As a result, the buffer solution can be sufficiently present on the outlet side of the buffer solution channel 610, which can prevent the flow rate of the buffer solution through the valve section 800 from decreasing. Therefore, it has the effect of stably maintaining the flow rate of the buffer solution.

[0200] Channel 600 includes a sample solution channel 620 connected to the sample solution container 320 and for supplying sample solution flow. Specifically, one side of the sample solution channel 620 is in communication with the internal space of the sample solution container 320. Additionally, the other side of the sample solution channel 620 is in communication with the sample solution port 625. With the operation of the valve section 800, the other side of the sample solution channel 620 can be connected to the sensing channel 630 via the sample solution port 625.

[0201] The sample solution channel 620 guides the sample solution flowing into the sample solution container 320 to the valve section 800. For example, the sample solution channel 620 is formed from the sample solution container 320 along a direction intersecting the length direction (major axis direction) of the frame 200, then bent and formed along the length direction of the frame 200, and then bent and formed along a direction intersecting the length direction. Therefore, the internal space of the sample solution container 320 can serve as the inlet of the sample solution channel 620, and the sample solution port 625 can serve as the outlet of the sample solution channel 620.

[0202] On the other hand, the internal space of the sample solution container 320 can serve as the inlet of the sample solution channel 620, and the sample solution port 625 can serve as the outlet of the sample solution channel 620.

[0203] At this time, the diameter of the internal space of the sample solution container 320 can be greater than the width of the outlet side of the sample solution channel 620. Furthermore, the width of at least a portion of the sample solution channel 620 can vary. For example, the sample solution channel 620 may be configured such that the width of the inlet side and the width of the outlet side are the same, while there is a narrowing section in between.

[0204] This prevents the flow rate of the sample solution flowing in the sample solution channel 620 from dropping instantaneously as the pump unit 900 operates. Therefore, it effectively maintains a stable flow rate of the sample solution.

[0205] Channel 600 may include a sensing channel 630 connected to buffer solution channel 610 or sample solution channel 620 and guiding the buffer solution or sample solution to biosensor 400. Specifically, one side of sensing channel 630 may communicate with sensing port 635. Additionally, the other side of sensing channel 630 may communicate with first tube connection port 660. With the operation of valve section 800, the other side of sensing channel 630 may communicate with a flow path formed inside tube 700 via first tube connection port 660.

[0206] The sensing channel 630 guides the buffer solution or sample solution flowing in through the valve section 800 to the biosensor 400, allowing it to pass through the biosensor 400. Specifically, the sensing channel 630 may include a first sensing channel 631 and a second sensing channel 632.

[0207] At this time, the first sensing channel 631 can guide the buffer solution or sample solution that has passed through the valve section 800 to the biosensor 400. For example, after the first sensing channel 631 is formed from the sensing channel 630 along the length direction (major axis direction) of the frame 200, it is bent and formed in a direction intersecting the length direction. As an example, after the first sensing channel 631 is formed from the sensing port 635 along the length direction (major axis direction) of the frame 200, it is bent and formed in the width direction. The other side of the first sensing channel 631 can communicate with the internal space of the sensor junction 211. Specifically, the first sensing channel 631 allows the buffer solution or sample solution to flow into the internal space of the sensor junction 211 through the inflow port 631a formed in the bottom frame 210.

[0208] With this structure, the buffer solution or sample solution passing through the first sensing channel 631 can flow on the upper surface of the biosensor 400.

[0209] On the other hand, the sensing port 635 can serve as the inlet of the first sensing channel 631, and the sensor joint 211 can serve as the outlet of the first sensing channel 631.

[0210] At this time, the width of the inlet side of the first sensing channel 631 can be greater than the width of the outlet side of the first sensing channel 631. Therefore, the buffer solution or sample solution can be sufficiently present at the inlet side of the first sensing channel 631, preventing the flow rate of the buffer solution or sample solution flowing in the first sensing channel 631 from dropping instantaneously with the operation of the pump unit 900. Thus, it has the effect of stably maintaining the flow rate of the buffer solution or sample solution.

[0211] Furthermore, the second sensing channel 632 can guide the buffer solution or sample solution that has passed through the biosensor 400 to the tube 700. For example, the second sensing channel 632 can communicate with the discharge port 632a formed in the bottom frame 210 and be formed along the left-right direction to communicate with the first tube connection port 660. In this case, the second sensing channel 632 can be arranged in a straight line with the downstream side of the first sensing channel 631. With such a structure, the flow path through the biosensor 400 can be formed into a straight shape, and the flow rate and / or flow volume of the buffer solution or sample solution flowing in the biosensor 400 can be stably maintained. Thus, the biosensor cartridge 1 of the present invention can improve the sensing accuracy of biological substances.

[0212] Channel 600 may include a pre-filled channel 640 communicating with sample solution channel 620 for sample solution flow. Specifically, one side of pre-filled channel 640 may communicate with sample solution channel 620. Additionally, one side of pre-filled channel 640 may communicate with sample solution port 625. Furthermore, the other side of pre-filled channel 640 may communicate with pre-filled port 645.

[0213] The pre-fill channel 640 can guide the sample solution that has passed through the sample solution channel 620 to the pre-fill port 645. For example, the pre-fill channel 640 may be configured to communicate with the sample solution channel 620 and be bent multiple times to communicate with the pre-fill port 645.

[0214] At this point, the width of at least a portion of the pre-filling channel 640 may vary. For example, the width of the inlet side of the pre-filling channel 640 may be the same as the width of the outlet side, with a narrowing interval in between.

[0215] Additionally, a valve 641 with a width greater than that of the inlet and outlet can be provided in the pre-filling channel 640. The valve 641 has the largest width in the pre-filling channel 640, and the inlet width into which the sample solution flows is the narrowest in the pre-filling channel 640. Thus, in the event of a large amount of sample solution flowing into the pre-filling channel 640 instantaneously, it is possible to prevent the sample solution from being discharged into the pre-filling port 645.

[0216] Channel 600 may include a waste solution channel 650 that guides the buffer solution or sample solution that has passed through tube 700 to waste solution tank 330. Specifically, one side of waste solution channel 650 may be connected to a second tube connection port 670. Additionally, the other side of waste solution channel 650 may be connected to a waste solution port 655. Therefore, when pump unit 900 is operating, the buffer solution or sample solution that has passed through tube 700 is stored in waste solution tank 330.

[0217] on the other hand, Figure 10 The diagram illustrates the integration of a biosensor and a printed circuit board into a frame within a biosensor cartridge according to one embodiment of the present invention. Figure 11 The diagram illustrates a sensor junction in a biosensor cartridge according to an embodiment of the present invention. Figure 12 A diagram is shown to illustrate the state of the biosensor in a biosensor cartridge according to an embodiment of the present invention. Figure 13 A cross-sectional view is shown to illustrate the contact between the biosensor and the printed circuit board in a biosensor cartridge according to an embodiment of the present invention. Figure 14 and Figure 15 A cross-sectional view is shown illustrating the configuration of the biosensor and printed circuit board in a biosensor box according to an embodiment of the present invention, as well as the configuration of the flow path flowing on the biosensor.

[0218] Reference Figures 10 to 15 The biosensor 400, contact clip 450 and printed circuit board 500 of a biosensor box 1 according to an embodiment of the present invention are described below.

[0219] The biosensor 400 can be detachably attached to the frame 200 and can sense biological substances. The biosensor 400 can be inserted through the sensor insertion hole 121 of the lower housing 120 and can be attached to the sensor attachment 211 of the bottom frame 210.

[0220] The biosensor 400 combines a biological receptor that has the function of recognizing specific biological substances with an electrical transducer to convert biological interactions and recognition responses into electrical signals to selectively sense a very small amount of biological substances to be analyzed.

[0221] The biosensor 400 of the present invention can be an electrochemical-based biosensor. Electrochemical-based biosensors combine the analytical capabilities of electrochemical methods with the specificity of biological recognition. They immobilize or contain biologically specific substances (sensing substances) such as enzymes, antigens, antibodies, and biochemical substances on the electrode surface, thereby detecting biological recognition phenomena of the target substance as changes in current or potential.

[0222] For example, a sensing element may be provided on the upper surface of the biosensor 400. A biological receptor may be disposed in the sensing element. A buffer solution and a sample solution may flow in the sensing element. The sensing element is connected to a circuit and can transmit an electrical signal generated by the sensing element.

[0223] The biosensor 400 may be configured with circuitry that can be electrically connected to the printed circuit board 500 via a contact clip 450.

[0224] One embodiment of the present invention provides a biosensor 400 that includes a graphene-based FET (Field Effect Transistor) in which a graphene layer is used as a channel.

[0225] The biosensor 400 includes: a substrate; a source electrode and a drain electrode disposed on the substrate spaced apart from each other; and a graphene layer disposed on the substrate with one end connected to the source electrode and the other end connected to the drain electrode.

[0226] On the other hand, the biosensor 400 may also include an insulating layer disposed on the substrate.

[0227] The source electrode, drain electrode, and graphene layer can be disposed on an insulating layer. This can improve the sensing sensitivity of the graphene-based sensor.

[0228] The substrate, as a semiconductor substrate, can be a silicon substrate. The insulating layer on the substrate can be formed of silicon oxide (SiO2) or silicon nitride. As an example, a silicon oxide-based insulating layer can be formed on the surface through heat treatment. On the other hand, a graphene layer can be formed on the insulating layer.

[0229] A portion of the graphene layer is left open for sensing, while other areas are covered by doped layers.

[0230] On the other hand, multiple graphene layers can be formed within the biosensor 400. Graphene layers can be formed on a portion of the insulating layer. Furthermore, the source electrode and drain electrode are spaced apart from each other and can be formed on both the insulating layer and a portion of the graphene layers.

[0231] The sample solution can come into contact with the open areas in the graphene layer of the biosensor 400 and a portion of the gate electrode.

[0232] On the other hand, in order to achieve a smooth connection between the sensing material and the graphene layer, a linker material can be attached. The linker material can vary depending on the graphene layer and the sensing material.

[0233] When the graphene layer is a polymer structure with nanoscale dimensions, the linker material may be composed of at least one of polyurethane, polydimethylsiloxane, NOA (Norland Optical Adhesives), epoxy resin, polyethylene terephthalate, polymethyl methacrylate, polyimide, polystyrene, polyethylene naphtharate, polycarbonate, and combinations thereof.

[0234] Alternatively, the linker material can be composed of a combination of polyurethane and NOA (e.g., NOA 68). However, the linker material is not limited to this and can be composed of various polymers with flexibility.

[0235] On the other hand, when a sample solution is introduced and corresponding voltages are applied to the source electrode, drain electrode, and gate electrode, and the target material is present in the sample solution, the target material and the sensing material react, thereby charging the graphene layer with specific charge carriers. This results in a depletion state of charge accumulation in the graphene layer, and the drain current flowing in the drain electrode increases.

[0236] On the other hand, when a sample solution is introduced and corresponding voltages are applied to the source electrode, drain electrode, and gate electrode respectively, and the target substance is not present in the sample solution, the drain current flowing in the drain electrode flows at a level much lower than the drain current when the target substance is present.

[0237] On the other hand, as a biological substance, a sample solution can represent a solution diluted with bodily fluids such as saliva and sweat, blood, serum, or plasma.

[0238] A seal 410 may be disposed on the upper side of the biosensor 400. The seal 410 may be disposed at the sensor joint 211. A flow path forming portion 411 may be formed in the seal 410. For example, the seal 410 may be formed in a cuboid shape, and the flow path forming portion 411 may be a slit shape formed along the left-right direction.

[0239] At this time, the flow path forming part 411 can be disposed on the lower side of the frame formed in the sensor joint 211. Specifically, the flow path forming part 411 is disposed on the lower side of the inflow port 631a and the discharge port 632a formed in the sensor joint 211, and can communicate with the inflow port 631a and the discharge port 632a. With this structure, the buffer solution and sample solution flowing in the first sensing channel 631 flow through the inflow port 631a in the flow path inside the flow path forming part 411, and can flow into the second sensing channel 632 through the discharge port 632a.

[0240] Additionally, the flow path forming portion 411 may be disposed on the upper side of the sensing portion of the biosensor 400. In this case, the seal 410 may be formed in a shape that surrounds the outer contour of the sensing portion. The seal 410 can achieve airtightness to the outer contour of the flow path forming portion 411, and can prevent the buffer solution and sample solution flowing inside the flow path forming portion 411 from flowing out to the outside.

[0241] The printed circuit board 500 can be detachably attached to the frame 200. At least a portion of the biosensor 400 can be inserted into the upper housing 110 and detachably attached to the substrate attachment portion 221 of the upper frame 220. The printed circuit board 500 can be supported by the attachment guide portion 221a and the substrate support portion 221b.

[0242] Specifically, the printed circuit board 500 may include a substrate body 510, a connector 520, and a guide portion 530. For example, the substrate body 510 may be generally formed in the shape of a rectangular flat plate. Circuitry is mounted on the substrate body 510 and can be electrically connected to the biosensor 400.

[0243] On the other hand, a connector 520 may be provided at the front end of the substrate body 510. The connector 520 can be connected to a circuit provided on the substrate body 510. Therefore, when the biosensor cartridge 1 is combined with the diagnostic device 2, an electrical signal can be sent to the diagnostic device 2 through the connector 520. In addition, when the biosensor cartridge 1 is combined with the diagnostic device 2, power can be applied to the printed circuit board 500 and the biosensor 400 through the connector 520.

[0244] The guide portion 530 may be formed at both ends of the substrate body 510 in the left-right direction and may be combined with the substrate support portion 221b of the substrate bonding portion 221. For example, the guide portion 530 is formed in a curved shape at both ends of the substrate body 510 in the left-right direction. Thus, combined with the protruding shape of the substrate support portion 221b, it can guide the printed circuit board 500 to the correct bonding position, and can stably support the printed circuit board 500 when it is bonded.

[0245] On the other hand, a contact clip 450 may be disposed between the biosensor 400 and the printed circuit board 500. The contact clip 450 is coupled to the sensor coupling portion 211 and can contact the printed circuit board 500 and the biosensor 400. In addition, the contact clip 450 is disposed through the clip receiving hole 221c and through the hole of the sensor coupling portion 211, and at least a portion of it is supported on the bottom frame 210.

[0246] Multiple contact clips 450 may be provided. An even number of contact clips 450 may be provided. In this case, multiple pairs of contact clips 450 are arranged side by side, and a pair of contact clips 450 may be arranged symmetrically at opposite positions. As an example, six contact clips 450 are formed, with three pairs of contact clips 45 arranged side by side, and each pair of contact clips 45 is arranged symmetrically at opposite positions.

[0247] Specifically, the contact clip 450 may be formed of a conductive material. For example, the contact clip 450 may be formed of a metallic material. Each contact clip 450 may include a substrate contact portion 451, a sensor contact portion 452, and a connecting portion 453.

[0248] The substrate contact portion 451 is configured via a receiving hole 221c. In this configuration, the substrate contact portion 451 can contact a terminal (not shown) disposed on the printed circuit board 500. That is, the substrate contact portion 451 can be electrically connected to a circuit mounted on the printed circuit board 500. For example, the substrate contact portion 451 can be a plate-shaped component extending in the front-back direction.

[0249] The sensor contact portion 452 is configured through a hole formed in the sensor connection portion 211 and can contact a terminal (not shown) provided on the biosensor 400. That is, the sensor contact portion 452 can be electrically connected to a circuit installed on the biosensor 400. For example, the sensor contact portion 452 can be in the form of a plate that extends downward from the connection portion 453, is then bent, and extends upward.

[0250] At this point, the total height of the contact clip 450 in the vertical direction is longer than the shortest distance between the biosensor 400 and the printed circuit board 500.

[0251] With this structure, when the sensor contact 452 comes into contact with the biosensor 400, the sensor contact 452 elastically deforms and applies pressure to the biosensor 400, minimizing the contact area with the biosensor 400 while maintaining a firm contact.

[0252] The connecting portion 453 can be formed to connect the substrate contact portion 451 and the sensor contact portion 452. In this case, the connecting portion 453 can be formed by bending and extending downward from the substrate contact portion 451, and then bending and extending along the front-back direction, and bending and extending downward to connect with the sensor contact portion 452. The connecting portion 453 can contact the bottom frame 210 and be supported.

[0253] Therefore, the contact clip 450 is mounted on the frame 200, with its upper side able to contact the printed circuit board and its lower side able to contact the biosensor 400. Thus, while the buffer solution and sample solution flow between the printed circuit board 500 and the biosensor 400 via the contact clip 450, the electrical signal generated by the biosensor 400 is transmitted to the printed circuit board with the shortest distance.

[0254] on the other hand, Figure 18 An exploded perspective view is shown for illustrating the valve section and pump section in a biosensor box according to an embodiment of the present invention. Figure 19 An exploded perspective view is shown for illustrating the valve section in a biosensor cartridge according to an embodiment of the present invention. Figure 20 A perspective view is shown illustrating a channel plate for illustrating a valve section in a biosensor cartridge according to an embodiment of the present invention. Figure 21 A bottom view is shown for illustrating the pump section in a biosensor cartridge according to an embodiment of the present invention. Figure 22 A diagram illustrating the process of tube compression as the pump rotates in a biosensor cartridge according to an embodiment of the present invention is shown.

[0255] Reference Figures 18 to 22 The tube 700, valve section 800 and pump section 900 of a biosensor box 1 according to an embodiment of the present invention are described below.

[0256] Tube 700 is connected to channel 600 for the flow of buffer solution or sample solution. Tube 700 is formed of a flexible material and has internal flow paths for fluid flow.

[0257] One end of tube 700 can be connected to a first tube connection port 660, and the other end of tube 700 can be connected to a second tube connection port 670. Thus, one side of tube 700 can communicate with the sensing channel 630, and the other side of tube 700 can communicate with the waste solution channel 650. Therefore, buffer solution or sample solution that has passed through the sensing channel 630 can flow into tube 700, and buffer solution or sample solution can be discharged into the waste solution channel 650.

[0258] The tube 700 can be attached to the tube receiving section 222. Specifically, the tube 700 is arranged along the inner circumferential surface of the pump receiving groove 221a and can surround at least a portion of the pump knob 910. At this time, a portion of the tube 700 is pressed between the pump knob 910 and the inner circumferential surface of the pump receiving groove 221a, causing it to elastically deform. Therefore, when the pump knob 910 is rotated, the tube 700 is pressed sequentially along the circumferential direction, thereby allowing the internal buffer solution or sample solution to flow. In addition, as the buffer solution or sample solution flows within the tube 700, a negative pressure is formed in the sensing channel 630, causing the buffer solution or sample solution to flow in. Furthermore, the buffer solution or sample solution is discharged into the waste solution channel 650 and discharged into the waste solution tank 330.

[0259] On the other hand, in conventional structures where fluid flows by pressing the tube as the pump rotates, even if the inflow and outflow sides are positioned close together, the tube is sharply bent in the area immediately before it is rolled into a circle, with the inflow and outflow sides bending in opposite directions. This creates an area where the tube cannot be pressed during the pump's 360-degree rotation.

[0260] In this situation, the tube pressed by the pump is instantly restored, causing backflow of the fluid flowing inside the tube. Therefore, there is a problem of backflow occurring throughout the entire flow path. In particular, when the flow rate of buffer solutions or sample solutions, such as in biosensor cartridges, needs to be kept stable, there is a potential for measurement errors.

[0261] To address this problem, in this invention, the tube 700 is arranged circumferentially around the pump knob 910, with the inflow and outflow sides intersecting each other. In this configuration, either the inflow or outflow side of the tube 700 can be stacked on top of the other. With this structure, the tube 700 completely surrounds the pump knob 910 at least once, preventing backflow of the buffer solution or sample solution during rotation of the pump knob 910.

[0262] Specifically, one side and the other side of the pipe 700 along its length can be respectively housed in the pipe guide groove 222b. At this time, the pipe guide groove 222b can be formed such that the grooves on one side and the other side of the pipe 700 merge into one, communicating with the pump receiving groove 222a. Furthermore, one side and the other side of the pipe 700 are housed in the merged pipe guide groove 222b in a stacked state.

[0263] Therefore, according to the present invention, the tube 700 is wound at least one turn, so that the flow rate and velocity of the buffer solution and / or sample solution can be stably maintained when the pump section 900 is running.

[0264] The valve part 800 can be rotatably coupled to the frame 200.

[0265] Specifically, the valve part 800 includes a valve housing 810, a valve knob 820, and a channel plate 830. At this time, at least a portion of the valve knob 820 is rotatably housed inside the valve housing 810, and the channel plate 830 can be attached to the lower side of the valve knob 820.

[0266] The valve portion 800 can be attached to the upper side of the upper frame 220. Specifically, the valve housing 810 can be attached to the valve connection portion 223. At this time, the valve housing 810 can be fixed to the frame 200 by attaching it with a fixing component such as a screw. At this time, the fixing component can pass through the bottom frame 210 and the upper frame 220 and be attached to the valve housing 810.

[0267] For example, the valve housing 810 may include a fixing portion 811 attached to the upper side of the upper frame 220 and a support portion 812 extending upward from the fixing portion. In this case, the fixing portion 811 may have a fixing component receiving portion, which is formed as a hollow circular block and extends radially outward to connect with the fixing component. Furthermore, the fixing portion 811 may have a knob receiving hole with a predetermined inner diameter formed at its radial center. Conversely, the support portion 812 is formed as a cylinder, and the inner diameter of the support portion 812 may be smaller than the inner diameter of the knob receiving hole of the fixing portion 811. That is, the inner circumferential surface of the valve housing 810 may be formed as a step.

[0268] The valve knob 820 can be set to rotate when subjected to external force.

[0269] At least a portion of the valve knob 820 is rotatably housed in the valve housing 810. For example, the valve knob 820 is formed in a cylindrical shape, and its outer peripheral surface may be formed into a step. That is, the valve knob 820 includes a large-diameter portion 821 and a small-diameter portion 822, the outer diameter of the large-diameter portion 821 being larger than the outer diameter of the small-diameter portion 822, and the large-diameter portion 821 being disposed further down than the small-diameter portion 822. In addition, the large-diameter portion 821 can be housed in the fixing portion 811 of the valve housing, and the small-diameter portion 822 can be housed in the support portion 812 of the valve housing.

[0270] This prevents the valve knob 820 from moving along the axial direction. As a result, the movement of the channel plate 830 located below the valve knob 820 in the axial direction (vertical direction) is restricted, which keeps the flow rate of the buffer solution or sample solution flowing along the flow path formed in the channel plate 830 stable.

[0271] On the other hand, a knob groove 823 is formed in the valve knob 820 to allow the application of external force. When the biosensor cartridge 1 is integrated into the diagnostic device 2, the knob groove 823 can engage with the valve actuator 24 provided in the diagnostic device 2. At this time, when the valve knob 820 is rotated, the knob groove 823 can guide the initial position. For example, the knob groove 823 can be formed with an uneven diameter. Thus, the knob groove 823 can be keyed with the valve actuator 24. With such a structure, the knob groove 823 and the valve actuator 24 can be induced to engage in the correct position.

[0272] On the other hand, the channel plate 830 is attached to the lower side of the valve knob 820 and can rotate together with the valve knob 820. Specifically, the channel plate 830 may include a plate body 831 and a connection guide hole 832. For example, the plate body 831 is formed in the shape of a disc and can be attached to the lower end of the valve knob 820. At this time, at least one or more connection protrusions (not shown) may be formed protrudingly on the lower end surface of the valve knob 820. At the same time, a connection guide hole 832 may be formed at a position on the plate body 831 opposite to the connection protrusion.

[0273] With this structure, when the engagement protrusion of the valve knob 820 engages with the engagement guide hole 832, the valve knob 820 and the channel plate 830 rotate in tandem. Furthermore, the position of the connection channel 833, described later, can be determined by the degree of rotation of the knob groove 823.

[0274] A connecting channel 833 may be formed in the channel plate 830. The connecting channel 833 may be formed on the lower surface of the channel plate 830, and at least two ports formed in the upper frame 220 may be connected to each other as the channel plate 830 rotates. For example, the connecting channel 833 may be formed in a recessed shape similar to a dumbbell. This allows the buffer solution or sample solution to flow in and out sufficiently, providing a stable flow rate and velocity.

[0275] The connection channel 833 can be configured to connect at least two of the buffer solution port 615, sample solution port 625, sensing port 635, and pre-filling port 645 to each other. As an example, the connection channel 833 can be configured as a single channel, with one side connected to the sensing port 635, and the other side connected to any one of the buffer solution port 615, sample solution port 625, and pre-filling port 645 as the channel plate 830 rotates. As another example, the connection channel 833 can be configured as two channels, respectively connected to the buffer solution port 615, sample solution port 625, sensing port 635, and pre-filling port 645, and the connected ports change as the channel plate 830 rotates.

[0276] Therefore, through the connection channel 833, the sensing port 635 can be connected to any one of the buffer solution port 615, the sample solution port 625 and the pre-filling port 645, so that when the pump unit 900 is running, the buffer solution or the sample solution flows into the sensing port 635.

[0277] Therefore, the valve knob 820 can open or close the channel 600 as it is rotated, so that the buffer solution or sample solution can selectively flow to the biosensor 400.

[0278] The pump unit 900 is rotatably coupled to the frame 200, and as it rotates, it applies pressure to the tube 700 to generate flow force for the buffer solution or sample solution flowing in the channel 600.

[0279] The pump unit 900 may include a pump knob 910 and a bearing 920.

[0280] The pump knob 910 can be disposed on the upper surface of the upper frame 220. The pump knob 910 can be rotatably engaged within the pipe housing 222. The pump knob 910 can be rotatably housed within the pump housing slot 222a.

[0281] Specifically, the pump knob 910 includes a shaft 911, a support portion 912, and a drive groove 913. The shaft 911 is formed in a cylindrical shape, providing the rotation axis for the pump knob 910. The radius of the shaft 911 from the rotation axis to its outer circumferential surface is not constant. That is, a cam 911a with the largest radius from the rotation axis can be formed on the shaft 911. Therefore, the shaft 911 has a cam-shaped outer circumferential surface, and thus the position of the pressing tube 700 can change as the shaft 911 rotates.

[0282] The support portion 912 can be disposed on the upper part of the shaft 911 and on the lower side of the upper housing 110.

[0283] The support portion 912 can be formed in the shape of a circular block. The support portion 912 can be integrally formed with the shaft 911. Therefore, the support portion 912 and the shaft 911 can rotate together.

[0284] The outer diameter of the support portion 912 can be larger than the maximum outer diameter of the shaft 911. In this case, the diameter of the support portion 912 can be larger than the diameter of the state in which the shaft 911, the bearing 920 surrounding the outer peripheral surface of the shaft, and the tube 700 surrounding the outer peripheral surface of the bearing 920 are combined. For example, the diameter of the support portion 912 can be the same as the diameter of the pump receiving groove 222a.

[0285] Thus, the support portion 912 can prevent the bearing 920 or the tube 700 from disengaging from the outside of the pump receiving groove 222a when the shaft 911 rotates.

[0286] In addition, the support portion 912 is supported by contact with the upper housing 110, thereby preventing the shaft 911 from shaking when an external rotational force is applied to the shaft 911.

[0287] The drive groove 913 can be disposed on the upper end of the support portion 912. The drive groove 913 can be formed to be subjected to external force. When the biosensor cartridge 1 is combined with the diagnostic device 2, the drive groove 913 can be combined with the pump actuator 25 provided in the diagnostic device 2. The drive groove 913 can be formed corresponding to the shape of the pump actuator 25. For example, the drive groove 913 can be formed in the shape of a cross groove.

[0288] Therefore, after the pump actuator 25 is coupled to the drive slot 913, a rotational force can be applied to the pump knob 910 when the pump actuator rotates.

[0289] The bearing 920 surrounds the outer circumferential surface of the shaft 911. When the shaft 911 rotates, the bearing 920 can come into contact with the tube 700. This prevents the shaft 911 from directly rubbing against the tube 700.

[0290] on the other hand, Figures 25 to 28 The figure shown illustrates the structure of a diagnostic device according to an embodiment of the present invention.

[0291] Reference Figures 25 to 28 The diagnostic device 2 is described below. Diagnostic device 2 can be a diagnostic device for biosensors.

[0292] When the biosensor box 1 is integrated, the diagnostic device 2 drives the valve section 800 and pump section 900 of the biosensor box 1 to receive the electrical signal generated by the biosensor 400 and diagnose the presence or absence of biological substances.

[0293] The diagnostic device 2 senses changes in electrical current related to the presence of trace amounts of target substances from the biosensor box 1, thereby diagnosing diseases and transmitting the results to the user.

[0294] The diagnostic device 2 includes a preprocessing procedure to correct the sensing signal from the biosensor box 1, so as to interpret subtle signal changes, thereby enabling it to compensate for the reproducibility and non-uniformity of the sensor.

[0295] The diagnostic device 2 may include: a QR reader that reads the QR code displayed on the biosensor box 1 and receives environmental information for performing authenticity authentication of the biosensor box 1; and a communication module that can send and receive signals for authenticating the biosensor box 1 with an external cloud server.

[0296] The diagnostic device 2 may be equipped with a program algorithm or application for measuring and analyzing sensing signals from the biosensor box 1 for diagnosing diseases, and different algorithms may be executed depending on the type of biosensor box 1.

[0297] The diagnostic device 2 may include a diagnostic device housing 21, a drive unit frame 22, a loading unit 23, a valve actuator 24, a pump actuator 25, and a diagnostic device control unit 26.

[0298] The diagnostic device housing 21 can form the appearance of the diagnostic device 2. The diagnostic device housing 21 can internally house the drive unit frame 22, the loading unit 23, the valve actuator 24, the pump actuator 25, and the diagnostic device control unit 26.

[0299] The diagnostic device housing 21 may include an operation unit 21a, a display 21b, and a cartridge slot 21c. The operation unit 21a is designed for user operation. For example, the operation unit 21a may be a dial. The display 21b may show the operating status of the diagnostic device 2 and display diagnostic results. Alternatively, according to an embodiment, the display 21b may be a touchscreen. In this case, the user can input commands via the display 21b. In this case, the operation unit 21a and the display 21b may be positioned on the upper part of the diagnostic device housing 21. This allows for easy operation by the user.

[0300] A cartridge inlet 21c may be formed in the diagnostic device housing 21 for inserting the biosensor cartridge 1. In this case, the width of the cartridge inlet 21c in the horizontal direction may be greater than its height in the vertical direction. That is, the biosensor cartridge 1 is positioned and inserted horizontally. This allows for stable flow of the buffer solution or sample solution flowing inside the biosensor cartridge 1.

[0301] On the other hand, the drive unit frame 22 can be disposed inside the diagnostic device housing 21 to support the loading unit 23, the valve actuator 24, and the pump actuator 25. The drive unit frame 22 can be coupled to the diagnostic device housing 21 for support.

[0302] The loading unit 23 is combined with the valve actuator 24 and the pump actuator 25, enabling the valve actuator 24 and the pump actuator 25 to move downwards and upwards. Specifically, the loading unit 23 may include a loading plate 23a and a loading actuator 23b. The loading plate 23a may be combined with the valve actuator 24 and the pump actuator 25. Furthermore, the loading plate 23a is connected to the loading actuator 23b via gears or the like, and can move upwards or downwards as the loading actuator 23b operates.

[0303] On the other hand, the valve actuator 24 can be coupled to the valve section 800. Specifically, the valve actuator 24 can be coupled to the valve knob 820 to rotate the valve knob 820.

[0304] Valve actuator 24 can be connected to actuator shaft 24a. For example, valve actuator 24 includes valve motor 24d, which is connected to actuator shaft 24a via gears connected to valve motor 24d, and actuator shaft 24a can be rotated by operation of valve motor 24d.

[0305] The actuator shaft 24a can be engaged with the knob slot 823 of the valve knob 820. When the loading plate 23a descends, the actuator shaft 24a can be engaged with the knob slot 823 of the valve knob 820.

[0306] At this time, the actuator shaft 24a can be coupled to the key frame 24ab. The key frame 24ab can be arranged in a direction intersecting the length direction of the actuator shaft 24a. For example, the key frame 24ab is formed in a cylindrical shape, arranged in a direction intersecting the length direction of the actuator shaft 24a, and can be configured to pass through the actuator shaft 24a. With such a structure, when the actuator shaft 24a descends, the key frame 24ab can be coupled to the knob slot 823. Furthermore, with the key frame 24ab coupled to the knob slot 823, when the actuator shaft 24a rotates, the valve knob 820 rotates in conjunction with it.

[0307] The actuator shaft 24a is formed in a cylindrical shape and can house a spring inside. A key frame 24ab can be configured at the lower end of the spring.

[0308] Therefore, when the loading plate 23a descends, if the key frame 24ab is not retracted into the knob slot 823, the spring is compressed, and the key frame 24ab can remain in contact with the upper end of the valve knob 820. In this state, when the actuator shaft 24a rotates, the key frame 24ab rotates together with the actuator shaft 24a. When the key frame 24ab is positioned on the vertical upper side of the knob slot 823, it engages with the knob slot 823 by the elastic force of the spring. Subsequently, when the actuator shaft 24a rotates, the valve knob 820 rotates in conjunction with it.

[0309] On the other hand, the actuator shaft 24a may include an alignment guide portion 24b. For example, the alignment guide portion 24b may be formed in the shape of a disk, through which the actuator shaft 24a may pass. A guide gap 24ba may be formed in the alignment guide portion 24b. The guide gap 24ba may be formed radially.

[0310] The alignment guide 24b can sense the original position of the actuator shaft 24a through the alignment sensing unit 24c. At this time, the alignment sensing unit 24c can sense the original position of the actuator shaft 24a by sensing the guide gap 24ba. For example, the alignment sensing unit 24c can be a photo interrupter. That is, the alignment sensing unit 24c includes a light source and a light receiving unit, either of which can be configured above the alignment guide 24b, and the other can be configured below the alignment guide 24b. Therefore, when the guide gap 24ba is configured between the light source and the light receiving unit, the original position of the actuator shaft 24a can be sensed.

[0311] On the other hand, the pump actuator 25 can be combined with the pump section 900. For example, the pump actuator 25 includes a pump motor 25d, which is connected to the actuator shaft 25a via a gear connected to the pump motor 25d, and the actuator shaft 25a is rotated by the operation of the pump motor 25d.

[0312] Pump actuator 25 can be connected to actuator shaft 25a. Pump actuator 25 is connected to actuator shaft 25a via gears, which allows actuator shaft 25a to rotate.

[0313] The actuator shaft 25a can be engaged with the drive slot 913 of the pump knob 910. When the loading plate 23a is lowered, the actuator shaft 25a can be engaged with the drive slot 913 of the pump knob 910.

[0314] At this time, a key frame (not shown) can be attached to the actuator shaft 25a. Additionally, an alignment guide 25b can be provided on the actuator shaft 25a. Furthermore, an alignment sensing part 25c can be provided on the pump actuator 25.

[0315] On the other hand, to avoid repetition, the key frame, alignment guide 25b and alignment sensing part 25 of the pump actuator 25 have the same structure and effect as the key frame 24ab, alignment guide 24b and alignment sensing part 24c of the pump actuator 24, so their contents can be quoted.

[0316] Reference Figure 34 The control relationship between the biosensor box 1 and the diagnostic device 2 of the present invention is explained below.

[0317] The diagnostic device control unit 26 can be configured inside the diagnostic device housing 21.

[0318] The diagnostic device control unit 26 may be composed of a printed circuit board and components mounted on the printed circuit board.

[0319] Although not shown, the diagnostic device control unit 26 may include a memory and a timer. This allows for the storage of preset data and the execution of control commands within a set time period.

[0320] The diagnostic device control unit 26 can control the loading actuator 23b. The diagnostic device control unit 26 controls the loading actuator 23b to raise or lower the loading unit 23.

[0321] On the other hand, the diagnostic device control unit 26 can control the valve actuator 24. Furthermore, the diagnostic device control unit 26 controls the valve actuator 24 to rotate the actuator shaft 24a. At this time, the diagnostic device control unit 26 can control the rotation angle of the actuator shaft 24a. For example, the diagnostic device control unit 26 can control the rotation of the valve motor 24d via an encoder, thereby controlling the rotation angle of the actuator shaft 24a. Thus, the diagnostic device control unit 26 can rotate the connection channel 833 of the valve section 800 to the correct position and accurately switch the connected channel 600.

[0322] Furthermore, the diagnostic device control unit 26 can be signal-connected to the alignment sensing unit 24c to sense whether the actuator shaft 24a is in its original position. Therefore, the diagnostic device control unit 26 controls the valve motor 24d to rotate the actuator shaft 24a back to its original position.

[0323] On the other hand, the diagnostic device control unit 26 can control the pump actuator 25. The diagnostic device control unit 26 can control the pump actuator 25 to rotate the actuator shaft 25a. At this time, the diagnostic device control unit 26 can control the rotational speed of the actuator shaft 25a. For example, the diagnostic device control unit 26 can control the rotational speed of the pump motor 25d via an encoder, thereby controlling the rotational speed of the actuator shaft 25a. Therefore, the diagnostic device control unit 26 can control the rotational speed of the pump unit 900 and thus control the flow rate of the buffer solution and sample solution flowing in the channel 600 and tube 700.

[0324] Furthermore, the diagnostic device control unit 26 can be signal-connected to the alignment sensing unit 25c to sense whether the actuator shaft 25a is in its original position. Therefore, the diagnostic device control unit 26 controls the pump motor 25d to rotate the actuator shaft 25a back to its original position.

[0325] Furthermore, the diagnostic device control unit 26 can be signal-connected to the operation unit 21a and the display 21b. When a user command is input, the diagnostic device control unit 26 can receive the user's command from the operation unit 21a. Additionally, the diagnostic device control unit 26 can send information to the display 21b. Thus, the current status of the diagnostic device 2 can be displayed.

[0326] Furthermore, the diagnostic device control unit 26 can be electrically connected to the biosensor box 1. Specifically, the diagnostic device control unit 26 can be electrically connected to the printed circuit board 500 disposed on the biosensor box 1. The diagnostic device control unit 26 receives electrical signals from the printed circuit board 500 and can sense the presence or absence of biological substances. In addition, the type of biological substance can be diagnosed based on pre-stored data.

[0327] Although not shown, the diagnostic device control unit 26 may include a communication unit. The diagnostic device control unit 26 can communicate with a terminal (not shown) via the communication unit. The communication unit can support wireless communication with other devices located outside the diagnostic device 2, including the terminal (not shown). As a wireless communication module for supporting wireless communication, it may include a short-range communication module or a long-range communication module. Thus, the status of the diagnostic device 2 or diagnostic results regarding biological substances can be sent to the user, and control commands from the user can be received remotely.

[0328] on the other hand, Figures 23 to 35 The diagram illustrates the process of diagnosing a sample solution placed into a biosensor cartridge using a diagnostic apparatus according to an embodiment of the present invention.

[0329] Reference Figures 23 to 35 The process of diagnosing a sample solution placed into a biosensor cartridge using a diagnostic apparatus according to an embodiment of the present invention is described below.

[0330] The biosensor cartridge 1 is in a state of being combined with the biosensor 400 and the printed circuit board 500. However, if the biosensor 400 and the printed circuit board 500 are faulty, the user can replace them.

[0331] The user can inject the buffer solution into the biosensor cartridge 1. Specifically, the user can inject it into the buffer solution inlet 111. In this invention, a buffer blister 3 can be used to inject the buffer solution into the buffer solution inlet 111.

[0332] For example, the upper part of the blister pack 3 can be formed in a dome shape, and the lower part can be formed in a planar shape. In this case, the upper part of the blister pack 3 is formed of a deformable material, and the lower part of the blister pack 3 is formed of a tearable material.

[0333] The buffer blister 3 can be stored in the blister storage slot 111a. At this time, the buffer blister 3 can not only be fixed to the blister storage slot 111a, but the buffer blister 3 can also be detachably attached to the blister storage slot 111a.

[0334] Therefore, with the blister pack 3 positioned inside the blister pack storage slot 111a, the user applies downward pressure to the blister pack 3 using their fingers or the like. In this situation, the upper part of the dome-shaped blister pack 3 deforms downwards, increasing the internal pressure. Simultaneously, the blister piercing portion 111d, protruding from the blister pack storage slot 111a, pierces the lower surface of the blister pack 3, breaking it open. Consequently, the buffer solution stored inside the blister pack 3 flows downwards due to gravity and into the buffer solution inlet 111 (see reference). Figure 23 ).

[0335] Furthermore, the buffer solution passing through the buffer solution inlet hole 111 can be collected in the buffer solution tank 310. It can also flow along the inclined surface 311 into the buffer solution inlet port 315. A portion of the buffer solution collected in the buffer solution tank 310 can flow along the buffer solution channel 610. However, when the pump unit 900 is not operating, it may not flow to the sensing channel 630.

[0336] On the other hand, the user can inject the sample solution into the sample solution inlet 112. At this time, the user can use the sample injection tool 4, including a dropper, to inject the sample solution into the sample solution inlet 112.

[0337] On the other hand, the buffer solution and the sample solution can be injected simultaneously, or the sample solution can be injected first and then the buffer solution, or the buffer solution can be injected after the sample solution.

[0338] The sample solution that has passed through the sample solution inlet 112 can be collected into the sample solution container 320. Furthermore, a portion of the sample solution collected in the sample solution container 320 flows along the sample solution channel 620. However, if the pump 900 is not operating, it may not flow into the sensing channel 630.

[0339] As a result, after adding the buffer solution and sample solution, the user can insert the biosensor box 1 into the diagnostic device 2.

[0340] On the other hand, before inserting the biosensor box 1 into the diagnostic device 2, the diagnostic device control unit 26 can confirm whether the actuator shafts 24a and 25a of the valve actuator 24 and the pump actuator 25 are aligned to their initial positions (original positions) (S10). That is, the diagnostic device control unit 26 can activate the alignment sensing units 24c and 25c, and sense whether the guide gaps 24ba and 25ba are in their initial positions through the alignment sensing units 24c and 25c.

[0341] When the user inserts the biosensor box 1 into the box inlet 21c formed in the diagnostic device 2, the valve knob 820 can be positioned vertically below the actuator shaft 24a of the valve actuator 24, and the pump knob 910 can be positioned vertically below the actuator shaft 25a of the pump actuator 25.

[0342] Additionally, although not shown, when the biosensor cartridge 1 is inserted into the diagnostic device 2, the printed circuit board 500 can be electrically connected to the terminals built into the diagnostic device 2. Power can then be applied to the printed circuit board 500 and the biosensor 400. Furthermore, the diagnostic device control unit 26 can sense the electrical signals received through the printed circuit board 500. Therefore, when power is applied from the diagnostic device 2 to the printed circuit board 500, the diagnostic device control unit 26 can sense that the biosensor cartridge 1 has been connected (S20).

[0343] On the other hand, although not shown, the diagnostic device 2 may also include a bonding sensing unit composed of a contact sensor such as a microswitch or a non-contact sensor such as an IR sensor. Through the bonding sensing unit, the diagnostic device control unit 26 can sense that the biosensor box 1 is bonded.

[0344] When the biosensor cartridge 1 is sensed being inserted into the diagnostic device 2, the diagnostic device control unit 26 can activate the loading actuator 23b. The diagnostic device control unit 26 can activate the loading actuator 23b to lower the loading plate 23a (S30). Therefore, the valve actuator 24 and the pump actuator 25 can move downwards. Thus, the actuator shaft 24a of the valve actuator 24 can be engaged with the valve knob 820, and the actuator shaft 25a of the pump actuator 25 can be engaged with the pump knob 910.

[0345] On the other hand, after the loading actuator 23b finishes operating, the diagnostic device control unit 26 operates the valve actuator 24 and / or the pump actuator 25, causing the actuator shafts 24a and 25a to rotate one revolution (S40). That is, the actuator shaft 24a of the valve actuator 24 and / or the actuator shaft 25a of the pump actuator 25 can rotate 360 ​​degrees. Therefore, even if the key frame 24ab initially provided on the actuator shafts 24a and 25a is not housed in the knob slot 823 or the drive slot 913, it can engage with the knob slot 823 or the drive slot 913 during one revolution of the actuator shafts 24a and 25a (see reference). Figure 30 Therefore, in subsequent processes, the valve knob 820 and / or the pump knob 910 can be aligned to their original positions, and the valve section 800 and the pump section 900 can be precisely controlled by the valve actuator 24 and / or the pump actuator 25.

[0346] Subsequently, the diagnostic device control unit 26 drives the valve actuator 24 and the pump actuator 25, and receives the electrical signal sensed by the biosensor 400 to sense biological substances.

[0347] First, the diagnostic device control unit 26 can perform a pre-loading step (S50).

[0348] In the pre-loading step (S50), the diagnostic device control unit 26 operates the valve actuator 24 to connect the pre-loading port 645 and the sensing port 635. At this time, the diagnostic device control unit 26 controls the valve actuator 24 so that the connection channel 833 is in a preset first position (see reference). Figure 31a ).

[0349] Furthermore, the diagnostic device control unit 26 operates the pump actuator 25 while the pre-filling port 645 and the sensing port 635 are connected. At this time, the diagnostic device control unit 26 can operate the pump actuator 25 for a preset time period. Thus, the sample solution stored in the sample solution container 320 flows into the pre-filling channel 640 (see reference 635) after passing through the sample solution channel 620. Figure 31b This results in the sample solution channel 620 being filled with sample solution, allowing air bubbles to be expelled into the pre-filling channel 640.

[0350] Afterwards, the diagnostic device control unit 26 can perform buffer solution circulation (step S60).

[0351] In the buffer solution circulation step (S60), the diagnostic device control unit 26 operates the valve actuator 24 to connect the buffer solution port 615 and the sensing port 635.

[0352] Therefore, the diagnostic device control unit 26 can control the valve actuator 24 so that the connection channel 833 is in a preset second position (see reference). Figure 32a ).

[0353] Furthermore, the diagnostic device control unit 26 can operate the pump actuator 25 while the buffer solution port 615 and the sensor port 635 are connected. At this time, the diagnostic device control unit 26 can operate the pump actuator 25 for a preset time period. Thus, the buffer solution contained in the buffer solution tank 310 can flow through the buffer solution channel 610 and then through the sensor channel 630 (see reference). Figure 32b ).

[0354] However, according to an embodiment, the pump actuator 25 may stop operating during the operation of the valve actuator 24. This is to prevent bubbles, buffer solution, or sample solution from leaking into the sensing channel 630 while the pump section 900 is operating during the change of the connected channel 600 of the valve section 800.

[0355] At this time, the diagnostic device control unit 26 can sense the electrical signals received through the printed circuit board 500. Therefore, the diagnostic device control unit 26 can determine whether there are errors in the printed circuit board 500 and / or the biosensor 400.

[0356] Afterwards, the diagnostic device control unit 26 can perform the sample solution circulation step (S70).

[0357] In the sample solution circulation step (S70), the diagnostic device control unit 26 operates the valve actuator 24 to connect the sample solution port 625 and the sensing port 635. At this time, the diagnostic device control unit 26 can control the valve actuator 24 so that the connection channel 833 is in a preset third position (see reference). Figure 33a ).

[0358] Furthermore, the diagnostic device control unit 26 operates the pump actuator 25 while the sample solution port 625 and the sensor port 635 are connected. At this time, the diagnostic device control unit 26 can operate the pump actuator 25 for a preset time period. Thus, the sample solution stored in the sample solution container 320 can flow through the sample solution channel 620 and then through the sensor channel 630 (see reference). Figure 33b ).

[0359] At this time, the diagnostic device control unit 26 can sense the electrical signal received through the printed circuit board 500 (S80). Furthermore, the diagnostic device control unit 26 compares the electrical signal value in the buffer solution circulation step (S60) and the electrical signal value in the sample solution circulation step (S70) to determine the presence or absence of biological substances.

[0360] Subsequently, the diagnostic device control unit 26 can display the presence or absence of biological substances on the display 21b.

[0361] Additionally, the diagnostic device control unit 26 can operate the valve actuator 24 to connect the buffer solution port 615 and the sensing port 635. At this time, the diagnostic device control unit 26 can control the valve actuator 24 so that the connection channel 833 is in a preset first position.

[0362] Furthermore, the diagnostic device control unit 26 can operate the pump actuator 25 while the buffer solution port 615 and the sensor port 635 are connected. At this time, the diagnostic device control unit 26 can operate the pump actuator 25 for a preset time period. As a result, the buffer solution stored in the buffer solution tank 320 flows to the waste solution tank 330 through the buffer solution channel 610, the sensor channel 630, and the pipe 700. During this process, the buffer solution cleans the channel 600 and the pipe 700.

[0363] Therefore, the flow path formed in the biosensor box 1 can be automatically cleaned, and some components of the biosensor box 1 can be reused.

[0364] Subsequently, when the pump actuator 25 stops operating, the diagnostic device control unit 26 can activate the loading actuator 23b. The diagnostic device control unit 26 activates the loading actuator 23b, causing the loading plate 23a to rise. Therefore, the valve actuator 24 and the pump actuator 25 can move upwards. As a result, the actuator shafts 24a and 25a can be separated from the valve knob 820 and the pump knob 910.

[0365] Afterwards, the diagnostic device control unit 26 can notify the user, through the display 21b, etc., that the diagnosis of the biosensor box 1 has ended.

[0366] Afterwards, the user can pull and separate the biosensor box 1 inserted into the diagnostic device 2.

[0367] The present invention has been described in detail above through specific embodiments. However, this is only for the purpose of specific description of the present invention. The present invention is not limited thereto, and those skilled in the art can make modifications or improvements within the technical concept of the present invention.

[0368] Simple modifications and alterations to this invention fall within the scope of this invention, and the specific scope of protection of this invention can be clearly understood through the appended claims.

Claims

1. A biosensor system, characterized in that, It includes: A biosensor cartridge includes: a frame disposed within a housing; a channel formed in the frame, providing a flow path for a buffer solution or a sample solution; a biosensor attached to the frame for detecting biological substances; and a pump that generates flow dynamics for the buffer solution or sample solution flowing in the channel; and A diagnostic device includes: a diagnostic device housing having a cartridge inlet for inserting the biosensor cartridge; and a pump actuator disposed within the diagnostic device housing and coupled to the pump unit to rotate the pump unit.

2. The biosensor system according to claim 1, characterized in that, When the biosensor box is inserted into the diagnostic device, the pump actuator descends and engages with the pump unit.

3. The biosensor system according to claim 1, characterized in that, The aforementioned biosensor box also includes: The valve selectively opens or closes the buffer solution channel into which the buffer solution flows or the sample solution channel into which the sample solution flows, so that the buffer solution or the sample solution flows into the biosensor.

4. The biosensor system according to claim 3, characterized in that, The aforementioned diagnostic device also includes: A valve actuator, which engages with the valve knob of the aforementioned valve section to rotate the aforementioned valve knob.

5. The biosensor system according to claim 4, characterized in that, When the biosensor box is inserted into the diagnostic device, the valve actuator descends and engages with the valve section.

6. The biosensor system according to claim 1, characterized in that, The above-mentioned pump actuator includes: An actuator shaft, which is connected to the aforementioned pump unit to rotate the aforementioned pump unit; The alignment guide portion has a diameter larger than the aforementioned actuator shaft, forms a guide slot, and rotates integrally with the aforementioned actuator shaft; and The alignment sensing unit senses the position of the guide gap when the alignment guide unit rotates. The pump actuator rotates the actuator shaft before the biosensor box is inserted into the diagnostic device, thereby aligning the alignment sensing part and the guide slot onto a vertical line.

7. A biosensor system, characterized in that, It includes: A biosensor cartridge includes: a frame disposed within a housing; a channel formed in the frame providing a flow path for a buffer solution or a sample solution; a biosensor attached to the frame for detecting biological substances; and a valve selectively opening and closing the channel to allow the buffer solution or the sample solution to flow into the biosensor; and A diagnostic device includes: a diagnostic device housing having a cartridge inlet for inserting the biosensor cartridge; and a valve actuator disposed within the diagnostic device housing, which engages with the valve portion to rotate the valve portion. The aforementioned channels include: Buffer solution channel, through which the aforementioned buffer solution flows; The sample solution channel, through which the aforementioned sample solution flows; and A sensing channel that guides the aforementioned buffer solution or sample solution to the aforementioned biosensor; After the valve connects the buffer solution channel and the sensing channel, it connects the sample solution channel and the sensing channel.

8. The biosensor system according to claim 7, characterized in that, The aforementioned channels also include: A pre-filling channel is connected to the sample solution channel, in which the sample solution flows.

9. The biosensor system according to claim 8, characterized in that, After the valve connects the pre-filling channel and the sensing channel, it connects the buffer solution channel and the sensing channel.

10. The biosensor system according to claim 7, characterized in that, The aforementioned biosensor box also includes: The pump unit generates flow force on the buffer solution or sample solution flowing in the aforementioned channel.

11. The biosensor system according to claim 10, characterized in that, The aforementioned diagnostic device also includes: A pump actuator, disposed within the housing of the diagnostic device and coupled to the pump unit, causes the pump unit to rotate. When the valve section stops rotating, the pump actuator is activated.

12. The biosensor system according to claim 7, characterized in that, When the biosensor box is inserted into the diagnostic device, the valve actuator descends and engages with the valve section.

13. The biosensor system according to claim 12, characterized in that, The aforementioned valve actuator includes: The actuator shaft, which is coupled to the aforementioned valve section, causes the valve section to rotate. After the valve actuator moves downward, the actuator shaft rotates one revolution.

14. A control method for a biosensor system, the control method being a control method for a diagnostic device, the diagnostic device being coupled to a biosensor cartridge including a biosensor, and sensing biological substances contained in a sample solution introduced into the biosensor cartridge, the control method being characterized in that it includes: The shaft alignment step aligns the actuator shaft of the valve actuator that rotates the valve section of the biosensor box and the actuator shaft of the pump actuator that rotates the pump section to their initial positions. In the loading step, when the biosensor cartridge is inserted, the valve actuator and the pump actuator are lowered and moved; and The diagnostic step involves rotating the valve and pump sections to sense the biological substance.

15. The control method for the biosensor system according to claim 14, characterized in that, In the above axis alignment steps, The actuator shaft is rotated, and the guide gap that rotates together with the actuator shaft is sensed by the alignment sensing unit.

16. The control method for the biosensor system according to claim 14, characterized in that, In the above loading steps, The loading plate, which is combined with the aforementioned valve actuator and pump actuator, moves downward.

17. The control method for the biosensor system according to claim 14, characterized in that, The above diagnostic steps include: The pre-loading step involves operating the valve actuator to rotate the connection channel formed in the valve section to a first position. The buffer solution circulation step, following the pre-filling step, involves operating the valve actuator to rotate the connection channel to a second position different from the first position; and The sample solution circulation step involves, after the buffer solution circulation step, operating the valve actuator to rotate the connection channel to a third position different from the first and second positions.

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