Biosensor system and control method thereof

Abstract

The present invention relates to a control method of a biosensor system, the method comprising: a shaft alignment step of aligning, to initial positions, an actuator shaft of a valve actuator for rotating a valve unit provided in a biosensor cartridge and an actuator shaft of a pump actuator for rotating a pump unit; a loading step of moving the valve actuator and the pump actuator downward when the biosensor cartridge is inserted; and a diagnosis step of detecting a biomaterial by rotating the valve unit and the pump unit, and thus being capable of diagnosing a biomaterial through a simple process of inserting the biosensor cartridge into a diagnostic device.

Description

Biosensor system and control method thereof

[0001] The present invention relates to a biosensor system and a control method thereof, and more specifically, to a biosensor system and a control method thereof that detects biological material to generate an electrical signal and detects the signal to diagnose the biological material.

[0002]

[0003] With the recent advancement of science and technology and the growing interest in the quality of life, the importance of disease diagnosis and prevention, as well as food and the environment, in human life is expanding day by day. As a result, there is an increasing need to measure the concentration of organic or inorganic substances in samples to diagnose human diseases, for specific processes in the fields of food chemistry and industrial chemistry, or to analyze pollutants in the environmental field, and many efforts are being made to address this.

[0004] A biosensor refers to a device that measures concentration by binding biomaterials, such as enzymes, microorganisms, antibodies, receptors, and DNA probes, to electrical or physicochemical transducers and detecting signals through electrochemical, optical, thermal, or piezoelectric methods based on electrode active substances or physical changes generated from reactions with the analyte to be measured.

[0005] Generally, the detection of biomaterials using biosensors is achieved through a combination of complex processes such as filtering, metering, mixing, transport, reaction, and washing. Therefore, conventionally, the detection of biomaterials is carried out manually at the laboratory level using various equipment.

[0006] Therefore, alongside the advancement of biosensor technology, the simultaneous development of fluid processing technology to automate and standardize the diagnostic process is crucial for low-cost, high-efficiency diagnosis.

[0007] Among these, equipment for detecting biomaterials requires flushing the internal flow paths before measuring each biological sample. Additionally, since large volumes of buffer solution must be stored in tanks to diagnose multiple samples, there is a risk of degradation, and there is the inconvenience of having to periodically empty the waste solution after diagnosis. Using such equipment presents limitations, as it may lead to reduced diagnostic speed and accuracy when a large volume of samples is required.

[0008] To solve this, a disposable biosensor cartridge with a built-in flow path through which buffer solution and sample solution can flow can be used. Since the disposable biosensor cartridge is used only once, a separate cleaning process is unnecessary. Additionally, since a single-use buffer solution is provided for each cartridge, there is no possibility of the buffer solution deteriorating, and the waste solution is emptied along with the cartridge when it is discarded.

[0009] In this regard, Korean published patent KR 10-2022-0047600A discloses a point-of-care molecular diagnostic system.

[0010] The above-described point-of-care molecular diagnostic system includes a cartridge and a diagnostic device, and can accommodate a biological sample in the cartridge and insert it into the diagnostic device to undergo various sample processing steps.

[0011] The above point-of-care molecular diagnostic system is configured to insert the cartridge into the diagnostic instrument by standing it upright.

[0012] In addition, a pneumatic device is provided to flow the buffer solution or sample solution; when a cartridge is inserted, pneumatic pressure is supplied to the inside of the cartridge to flow the buffer solution or sample solution.

[0013] However, as described above, when the cartridge is inserted in a direction perpendicular to the ground, the buffer solution or sample solution may flow due to gravity, so there is a limitation in that the buffer solution or sample solution flows regardless of the operation of the diagnostic device, making precise control impossible.

[0014] In addition, since a relatively bulky pneumatic device must be equipped in the diagnostic device, the volume of the diagnostic equipment may increase, which may cause inconvenience when transporting to the site where diagnosis is required or when installing it at the site.

[0015] In addition, since pneumatic devices have difficulty with fine control of output, it is difficult to control the flow rate and velocity of the buffer solution or sample solution flowing inside the cartridge, which leads to errors in diagnostic data and a decrease in accuracy, thus presenting a limitation.

[0016]

[0017] The present invention was created to improve upon the problems described above, and aims to provide a biosensor cartridge that allows a user to easily diagnose biomaterials through a simple process.

[0018] In addition, the purpose is to provide a biosensor cartridge that enables easy diagnosis of biomaterials at the site where diagnosis is required, without spatial constraints.

[0019] In addition, the purpose is to provide a biosensor cartridge that allows for diagnosis without spatial constraints and facilitates easy transport to sites requiring diagnosis by configuring the diagnostic device in a compact size.

[0020] In addition, the purpose is to provide a biosensor cartridge capable of stably controlling the flow rate and velocity of a buffer solution or sample solution flowing within the cartridge.

[0021] In addition, the purpose is to provide a biosensor cartridge that can prevent the decrease in sensing accuracy caused by inconsistent solution flow rates for each diagnostic biosensor cartridge.

[0022] In addition, the purpose is to provide a biosensor cartridge that can stably maintain the flow of a buffer solution or sample solution and stably transmit electrical signals while miniaturizing the size of the biosensor.

[0023] In addition, the purpose is to provide a biosensor cartridge that allows only the biosensor to be easily replaced without disassembling the entire cartridge in the event of a defect in the biosensor.

[0024] In addition, the purpose is to provide a biosensor cartridge that allows for easy injection of a buffer solution and prevents contamination of the buffer solution.

[0025] In addition, the purpose is to provide a biosensor cartridge capable of automatically flowing a buffer solution or sample solution into a biosensor and detecting biomaterials through the biosensor with only a simple process of insertion into a diagnostic device.

[0026]

[0027] To solve the problem described above, a biosensor system according to the present invention comprises: a biosensor cartridge including a frame disposed within a housing, a channel formed in the frame that provides a path for a buffer solution or a sample solution to flow through, a biosensor coupled to the frame to detect a biomaterial, and a pump unit that generates a flow force for the buffer solution or the sample solution flowing through the channel; a diagnostic device housing having a cartridge inlet formed therein into which the biosensor cartridge is inserted, and a pump actuator disposed within the diagnostic device housing and coupled to the pump unit to rotate the pump unit.

[0028] At this time, when the biosensor cartridge is inserted into the diagnostic device, the pump actuator can descend and be coupled to the pump unit.

[0029] Additionally, the biosensor cartridge may further include a valve portion that selectively opens or closes a buffer solution channel into which the buffer solution is introduced or a sample solution channel into which the sample solution is introduced, thereby introducing the buffer solution or the sample solution toward the biosensor.

[0030] Additionally, the diagnostic device may further include a valve actuator that is coupled to the valve knob of the valve part and rotates the valve knob.

[0031] At this time, when the biosensor cartridge is inserted into the diagnostic device, the valve actuator can descend and be coupled to the valve part.

[0032] Meanwhile, the pump actuator may include: an actuator shaft coupled to the pump unit and rotating the pump unit; an alignment guide unit formed with a larger diameter than the actuator shaft and having a guide slit formed therein, and rotating integrally with the actuator shaft; and an alignment detection unit that detects the position of the guide slit when the alignment guide unit rotates.

[0033] At this time, the pump actuator can rotate the actuator shaft to position the alignment detection part and the guide slit on a vertical line before the biosensor cartridge is inserted into the diagnostic device.

[0034] At this time, the channel comprises: a buffer solution channel into which the buffer solution is introduced; a sample solution channel into which the sample solution is introduced; and a sensing channel that guides the buffer solution or the sample solution to the biosensor; and the valve portion can connect the buffer solution channel and the sensing channel, and then connect the sample solution channel and the sensing channel.

[0035] Additionally, the channel may further include a prefill channel in which the sample solution flows, which is in communication with the sample solution channel.

[0036] Meanwhile, the valve section can connect the prefill channel and the normal sensing channel, and then connect the buffer solution channel and the sensing channel.

[0037] Meanwhile, the pump actuator can be operated when the rotation of the valve part stops.

[0038] Meanwhile, the valve actuator includes an actuator shaft coupled to the valve part and rotating the valve part; and after the valve actuator moves downward, the actuator shaft can rotate one full turn.

[0039] Meanwhile, to solve the problem described above, a control method for a biosensor system according to the present invention comprises: a shaft alignment step of aligning the actuator shaft of a valve actuator that rotates a valve part provided in a biosensor cartridge and the actuator shaft of a pump actuator that rotates 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 diagnostic step of detecting the biomaterial by rotating the valve part and the pump part.

[0040] At this time, in the shaft alignment step, while rotating the actuator shaft, a guide slit rotating together with the actuator shaft can be detected through the alignment detection unit.

[0041] In addition, during the loading step, the loading plate combined with the valve actuator and the pump actuator can be moved downward.

[0042] Additionally, the diagnostic step may include: a prefill step of operating the valve actuator to rotate the connection channel formed in the valve part to a first position; a buffer solution circulation step of operating the valve actuator to rotate the connection channel to a second position different from the first position after the prefill step; and a sample solution circulation step of operating the valve actuator to rotate the connection channel to a third position different from the first position and the second position after the buffer solution circulation step.

[0043]

[0044] As explained above, the biosensor system according to the present invention has the effect of automatically diagnosing biomaterials through a simple process of inserting the biosensor cartridge into a diagnostic device by equipping the biosensor cartridge with a valve part and a pump part.

[0045] In addition, since the valve and pump units are embedded in the biosensor cartridge, it is possible to detect biomaterials by operating the valve and pump units without spatial constraints when necessary.

[0046] In addition, since the valve and pump sections are embedded in the biosensor cartridge and the diagnostic device is equipped with only a simple actuator, the device can be configured compactly for easy transport and effectively eliminate spatial constraints on the installation location.

[0047] In addition, when the pump unit rotates, it presses the tube, which has the effect of stably flowing the buffer solution or sample solution.

[0048] In addition, using a graphene-based biosensor offers the advantage of enabling both miniaturization and sensitive sensing.

[0049] In addition, since a hydrophilic adhesive layer is formed using a hydrophilic tape between the base frame and the top frame, the flow rate of the solution can be maintained at a constant level regardless of the environment in which the diagnosis is performed.

[0050] In addition, the purpose is to provide a biosensor cartridge that can stably maintain the flow of a buffer solution or sample solution and stably transmit electrical signals while miniaturizing the size of the biosensor.

[0051] In addition, if a defect occurs in the biosensor, it has the effect of allowing only the biosensor to be replaced after removing only the sensor cover.

[0052] In addition, by providing a buffer blister, the buffer solution can be injected by simply bursting the sealed buffer blister, and the buffer solution can be prevented from being contaminated.

[0053] In addition, the rotation of the valve section has the effect of automatically flowing the buffer solution and sample solution sequentially.

[0054]

[0055] FIG. 1 is a drawing for explaining a biosensor cartridge and a diagnostic device according to one embodiment of the present invention.

[0056] FIG. 2 is a perspective view illustrating a biosensor cartridge according to one embodiment of the present invention.

[0057] Figure 3 is an exploded perspective view of Figure 2.

[0058] Figure 4 is a plan view of Figure 2.

[0059] FIG. 5 is a plan view illustrating the state in which the upper housing has been removed from FIG. 4.

[0060] FIG. 6 is an exploded perspective view for explaining a frame according to one embodiment of the present invention.

[0061] FIG. 7 is a plan view for explaining a top frame according to one embodiment of the present invention.

[0062] FIG. 8 is a cross-sectional view of a frame according to one embodiment of the present invention.

[0063] FIG. 9 is a bottom view illustrating a channel formed in a top frame according to one embodiment of the present invention.

[0064] FIG. 10 is a diagram illustrating the combination of a biosensor and a printed circuit board to a frame in a biosensor cartridge according to one embodiment of the present invention.

[0065] FIG. 11 is a drawing for explaining a sensor coupling portion in a biosensor cartridge according to one embodiment of the present invention.

[0066] FIG. 12 is a diagram illustrating the state in which a biosensor is coupled in a biosensor cartridge according to one embodiment of the present invention.

[0067] FIG. 13 is a cross-sectional view illustrating the contact between a biosensor and a printed circuit board in a biosensor cartridge according to one embodiment of the present invention.

[0068] FIGS. 14 and 15 are cross-sectional views illustrating the arrangement of a biosensor and a printed circuit board and the arrangement of a flow path flowing over the biosensor in a biosensor cartridge according to one embodiment of the present invention.

[0069] FIGS. 16 and 17 are drawings for explaining the process of opening and closing a sensor cover in a biosensor cartridge according to one embodiment of the present invention.

[0070] FIG. 18 is an exploded perspective view for explaining the valve part and the pump part in a biosensor cartridge according to one embodiment of the present invention.

[0071] FIG. 19 is an exploded perspective view for explaining the valve portion in a biosensor cartridge according to one embodiment of the present invention.

[0072] FIG. 20 is a perspective view illustrating a channel plate of a valve portion in a biosensor cartridge according to one embodiment of the present invention.

[0073] FIG. 21 is a bottom view illustrating a pump portion in a biosensor cartridge according to one embodiment of the present invention.

[0074] FIG. 22 is a diagram illustrating the process of compressing a tube according to the rotation of a pump part in a biosensor cartridge according to one embodiment of the present invention.

[0075] FIG. 23 is a diagram illustrating the process of introducing a buffer solution as a buffer blister bursts in a biosensor cartridge according to one embodiment of the present invention.

[0076] FIG. 24 is a diagram illustrating the process of introducing a sample solution into a biosensor cartridge according to one embodiment of the present invention.

[0077] FIG. 25 is a perspective view illustrating the state in which a biosensor cartridge according to one embodiment of the present invention is inserted into a diagnostic device.

[0078] FIG. 26 is a perspective view illustrating the internal configuration of a diagnostic device according to one embodiment of the present invention.

[0079] FIG. 27 is a drawing for explaining an actuator in a diagnostic device according to one embodiment of the present invention.

[0080] FIG. 28 is a diagram illustrating a configuration for aligning actuators in a diagnostic device according to an embodiment of the present invention.

[0081] FIG. 29 is a diagram illustrating the process of an actuator descending and being coupled with a biosensor cartridge in a diagnostic device according to an embodiment of the present invention.

[0082] FIG. 30 is a diagram illustrating the process of aligning the position of a valve part while an actuator rotates in a diagnostic device according to an embodiment of the present invention.

[0083] FIG. 31a is a drawing illustrating the rotation of a valve portion during the prefill stage in a biosensor cartridge and diagnostic device according to one embodiment of the present invention.

[0084] FIG. 31b is a diagram illustrating the flow of a sample solution in the prefill step of a biosensor cartridge and diagnostic device according to one embodiment of the present invention.

[0085] FIG. 32a is a diagram illustrating the rotation of a valve part in the buffer solution circulation step of a biosensor cartridge and diagnostic device according to one embodiment of the present invention.

[0086] FIG. 32b is a diagram illustrating the flow of a buffer solution in the buffer solution circulation step of a biosensor cartridge and diagnostic device according to one embodiment of the present invention.

[0087] FIG. 33a is a diagram illustrating the rotation of a valve portion during the sample solution circulation step in a biosensor cartridge and diagnostic device according to one embodiment of the present invention.

[0088] FIG. 33b is a diagram illustrating the flow of a sample solution in the sample solution circulation step of a biosensor cartridge and diagnostic device according to one embodiment of the present invention.

[0089] FIG. 34 is a block diagram illustrating control relationships in a biosensor cartridge and diagnostic device according to one embodiment of the present invention.

[0090] FIG. 35 is a flowchart for explaining a control method of a diagnostic device according to an embodiment of the present invention.

[0091]

[0092] Preferred embodiments of the present invention will be described in detail below with reference to the attached drawings.

[0093] The present invention is capable of various modifications and may have various embodiments, and specific embodiments are illustrated in the drawings and described in detail in the detailed description. This is not intended to limit the present invention to specific embodiments, and should be interpreted to include all modifications, equivalents, and substitutions that fall within the spirit and scope of the invention.

[0094] In describing the present invention, terms such as "first," "second," etc., may be used to describe various components, but said components may not be limited by said terms. Such terms are used solely for the purpose of distinguishing one component from another. For example, without departing from the scope of the present invention, the first component may be named the second component, and similarly, the second component may be named the first component.

[0095] The term "and / or" may include a combination of multiple related listed items or any of the multiple related listed items.

[0096] When it is stated that one component is "connected" or "connected" to another component, it can be understood that while it may be directly connected or connected to that other component, there may also be other components in between. On the other hand, when it is stated that one component is "directly connected" or "directly connected" to another component, it can be understood that there are no other components in between.

[0097] The terms used in this application are used merely to describe specific embodiments and are not intended to limit the invention. Singular expressions may include plural expressions unless the context clearly indicates otherwise.

[0098] In this application, terms such as “comprising” or “having” are intended to indicate the existence of the features, numbers, steps, actions, components, parts, or combinations thereof described in the specification, and should be understood as not excluding in advance the existence or addition of one or more other features, numbers, steps, actions, components, parts, or combinations thereof.

[0099] Unless otherwise defined, all terms used herein, including technical or scientific terms, may have the same meaning as generally understood by those skilled in the art to which the present invention pertains. Terms such as those defined in commonly used dictionaries may be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and may not be interpreted in an ideal or overly formal sense unless explicitly defined in this application.

[0100] In addition, the following embodiments are provided to explain more completely to those with average knowledge in the industry, and the shapes and sizes of the elements in the drawings may be exaggerated for clearer explanation.

[0101]

[0102] FIG. 1 illustrates a diagram for explaining a biosensor cartridge and a diagnostic device according to an embodiment of the present invention, FIG. 2 to FIG. 4 illustrates a diagram for explaining a biosensor cartridge according to an embodiment of the present invention, and FIG. 5 illustrates a plan view for explaining the state in which the upper housing in FIG. 4 has been removed.

[0103] For reference, in the present invention, target materials are biomaterials representing a specific substrate and can be interpreted as having the same meaning as analytes. In the present invention, probe materials are biomaterials that specifically bind to target materials and can be interpreted as having the same meaning as receptors or acceptors. In this embodiment, biomaterials may be antigens, antibodies, DNA, small molecule organics, proteins, peptides, amino acids, ligand proteins, etc.

[0104]

[0105] Referring to FIGS. 1 to 5, a biosensor cartridge (1) according to one embodiment of the present invention is described as follows.

[0106] A biosensor system according to one embodiment of the present invention includes a biosensor cartridge (1) and a diagnostic device (2). The biosensor cartridge (1) according to one embodiment of the present invention is coupled to the diagnostic device (2) to detect biomaterials and thereby diagnose diseases, etc.

[0107] At this time, the biosensor cartridge (1) of the present invention can be inserted into the diagnostic device (2) in a state arranged along the horizontal direction. Additionally, the biosensor cartridge (1) can flow buffer solution and sample solution inside to cause the biosensor (400) to undergo an electrochemical reaction with the biomaterial, and can transmit the resulting electrical change to the diagnostic device (2) through the printed circuit board (500).

[0108] Specifically, the biosensor cartridge (1) includes a housing (100), a frame (200), a tank (300), a biosensor (400), a printed circuit board (500), a channel (600), a tube (700), a valve section (800), and a pump section (900).

[0109] At this time, a frame (200) is accommodated inside the housing (100), a tank (300) is formed on the upper side of the frame (200), and a channel (600) may be formed inside the frame (200). Additionally, a tube (700), a valve section (800), and a pump section (900) are coupled to the frame (200), and a biosensor (400) and a printed circuit board (500) may be detachably coupled.

[0110] For reference, in the present invention, the direction in which the buffer solution is introduced relative to the frame (200) can be called the upper side, and the direction opposite to the upper side relative to the frame (200) can be 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 placed relative to the housing (100) can be called the front. Additionally, the direction opposite to the front can be called the rear. Furthermore, when looking forward from the rear end of the housing (100), the direction placed on the left can be called the left side, and the direction placed on the right can be called the right side.

[0111] The housing (100) forms the outer shape of the biosensor cartridge (1) and can accommodate a frame (200), a tank (300), a biosensor (400), a printed circuit board (500), a channel (600), a tube (700), a valve section (800), and a pump section (900) inside.

[0112] The housing (100) includes an upper housing (110) and a lower housing (120).

[0113] For example, the upper housing (110) may be formed in the shape of a square 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) may be formed on the upper side.

[0114] The buffer solution inlet hole (111) can be formed to allow the buffer solution to flow in. The buffer solution inlet hole (111) can be formed in the blister receiving groove (111a). At this time, the blister receiving groove (111a) can be positioned vertically above the buffer solution tank (310). Accordingly, the buffer solution inlet hole (111) is also positioned vertically above the buffer solution tank (310), and the buffer solution inlet hole (111) can be formed to communicate with the internal space of the buffer solution tank (310).

[0115] A buffer blister (3) can be coupled to the blister receiving groove (111a). The blister receiving groove (111a) may be formed by being recessed downward on the upper side of the upper housing (110) in correspondence with the shape of the buffer blister (3). For example, the blister receiving groove (111a) may be formed by being recessed in the shape of a square groove or a circular groove on the upper side of the upper housing (110). Additionally, at least one blister punch (111d) for piercing the buffer blister (3) may be formed protrudingly in the blister receiving groove (111a). At this time, the blister punch (111d) may be arranged along the circumferential direction with the buffer solution injection hole (111) as the origin.

[0116] With this configuration, when the buffer blister (3) is pressurized while being received inside the blister receiving groove (111a), the blister punch (111d) bursts the buffer blister (3), allowing the buffer solution to pass through the buffer solution inlet hole (111) and flow into the buffer solution tank (310).

[0117] Meanwhile, according to an embodiment, at least one ventilation hole (111b, 116) may be formed on the upper surface of the upper housing (110). The ventilation hole (111b, 116) may be formed so that air inside the housing (100) can be discharged to the outside.

[0118] Specifically, a first ventilation hole (111b) may be formed on the upper surface of the upper housing (110). At this time, the first ventilation hole (111b) may be positioned vertically above the buffer solution tank (310). Thus, the first ventilation hole (111b) may be formed to communicate with the internal space of the buffer solution tank (310). With this configuration, when the buffer solution flows into the buffer solution tank (310), the air inside the buffer solution tank (310) can be discharged to the outside through the first ventilation hole (111b). Therefore, there is an advantage in preventing the air pressure inside the buffer solution tank (310) from rising and reducing the probability of air mixing with the buffer solution.

[0119] Additionally, according to an embodiment, a first ventilation channel (111c) may be further formed on the upper surface of the upper housing (110). The first ventilation channel (111c) is formed to communicate with the first ventilation hole (111b) and may be formed in a groove shape along the upper surface of the upper housing (110). At this time, the ventilation channel (111c) may be formed not only as a straight groove but also in a shape that is bent multiple times on the upper surface of the upper housing (110). This is to secure the maximum length of the channel within a limited area. With this configuration, when a label (130) is attached to the upper surface of the upper housing (110), the first ventilation channel (111c) can form a space between the upper housing (110) and the label (130) to receive air discharged through the first ventilation hole (111b).

[0120] The sample solution inlet hole (112) can be formed to allow the sample solution to flow in. The sample solution inlet hole (112) can be positioned vertically above the sample solution tank (320). Thus, the sample solution inlet hole (112) can be formed to communicate with the internal space of the sample solution tank (320). Meanwhile, a stopper (112a) can be detachably connected to the sample solution inlet hole (112). Thus, when the stopper (112a) is connected, the sample solution inlet hole (112) can be blocked. Also, when the stopper (112a) is removed, the sample solution inlet hole (112) is opened so that the sample solution can be injected. Meanwhile, after the sample solution is injected, if the sample solution inlet hole (112) is blocked through the stopper (112a), it is possible to prevent foreign substances from flowing into the sample solution inlet hole (112).

[0121] The valve connection hole (113) may be formed so that a part of the valve portion (800) passes through it. The valve connection hole (113) may be positioned on the upper side of the valve coupling portion (223). At this time, the valve connection hole (113) may be formed in the shape of a circular hole, and a valve knob (820) may be positioned to pass through the valve connection hole (113). The valve knob (820) may rotate within the valve connection hole (113).

[0122] The pump connection hole (114) may be formed so that a part of the pump section (900) passes through it. The pump connection hole (114) may be positioned above the valve connection section (223). Specifically, the pump connection hole (114) may be positioned above the pump receiving groove (222a). At this time, the pump connection hole (114) may be formed in the shape of a circular hole, and the pump knob (910) may be positioned to pass through the valve connection hole (113). The pump knob (910) may rotate within the pump connection hole (114).

[0123] Meanwhile, a support projection (115) may be formed protruding from the upper surface of the upper housing (110) to support the printed circuit board (500) into the interior of the housing (100). The support projection (115) may be positioned vertically above the substrate coupling portion (221) of the frame (200). The support projection (115) may contact the upper surface of the printed circuit board (500) to support the printed circuit board (500).

[0124] Meanwhile, according to an embodiment, a second ventilation hole (116) may be further formed on the upper surface of the upper housing (110). In this case, the second ventilation hole (116) may be positioned vertically above the waste solution tank (330). Accordingly, the second ventilation hole (116) may be formed to communicate with the internal space of the waste solution tank (330). With this configuration, when a 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 ventilation hole (116). Accordingly, it is possible to prevent the air pressure inside the waste solution tank (330) from rising.

[0125] Additionally, according to an embodiment, a second ventilation channel (116a) may be further formed on the upper surface of the upper housing (110). The second ventilation channel (116a) is formed to communicate with the second ventilation hole (116) and may be formed in a groove shape along the upper surface of the upper housing (110). At this time, the second ventilation channel (116a) may be formed not only as a straight groove but also in a shape that is bent multiple times on the upper surface of the upper housing (110). This is to secure the maximum length of the channel within a limited area. With this configuration, when a label (130) is attached to the upper surface of the upper housing (110), the second ventilation channel (116a) forms a space between the upper housing (110) and the label (130) to accommodate air discharged through the second ventilation hole (116).

[0126]

[0127] The lower housing (120) can be combined with the upper housing (110) to form a space that accommodates a frame (200), a tank (300), a biosensor (400), a printed circuit board (500), a channel (600), a tube (700), a valve section (800), and a pump section (900) inside.

[0128] For example, the lower housing (120) may be formed in the shape of a square box with an open top and may be combined with the upper housing (120). At this time, a plurality of hooks may be formed protruding toward the upper housing (110) on the side wall of the lower housing (120) and may be inserted into a groove (not shown) formed on the side wall of the upper housing (110) to be combined.

[0129] At this time, the attachment between the upper housing (110) and the lower housing (120) can be further strengthened by performing fusion or bonding on the edge attachment area of ​​the upper housing (110) and the lower housing (120). Such fusion can be achieved by ultrasonic fusion, but is not limited thereto, and can be achieved through a separate adhesive member. Through this, moisture or foreign substances from the outside can be prevented from penetrating into the interior.

[0130] Meanwhile, a sensor insertion hole (121) into which a biosensor (400) can be inserted may be formed on the lower surface of the lower housing (120). At this time, the diameter of the sensor insertion hole (121) may be larger than the diameter of the sensor coupling part (211) to be described later. For example, the sensor insertion hole (121) may be formed in the shape of a circular hole, and a pair of cover coupling parts (121a) may be formed protruding radially inward on at least a part of the side wall surrounding the sensor insertion hole (121). The cover coupling part (121a) may be coupled with and supported by the hook (122a) of the sensor cover (122).

[0131] Additionally, a sensor cover (122) may be attached to the lower side 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.

[0132] The sensor cover (122) includes a hook (122a), a sensor support (122b), and a coupling guide groove (122c). For example, the sensor cover (122) may be formed in the shape of a disc overall, with the hook (122a) and the sensor support (122b) protruding from the upper surface of the sensor cover (122), and the coupling guide groove (122c) recessed from the lower surface of the sensor cover (122). At this time, the diameter of the sensor cover (122) may be formed to correspond to the diameter of the sensor insertion hole (121). For example, the diameter of the sensor cover (122) may be formed to be the same as the diameter of the sensor insertion hole (121).

[0133] The hook (122a) is formed to protrude upward from the upper surface of the sensor cover (122), and the upper portion may be formed to protrude radially outward. For example, a pair of hooks (122a) may be formed in a position facing each other and may be formed along a predetermined angle range along the circumferential direction. With this configuration, the hook (122a) can be positioned above the cover coupling part (121a) when the sensor cover (122) is rotated after being inserted into the sensor insertion hole (121) where the cover coupling part (121a) is not formed. Accordingly, the cover coupling part (121a) is positioned between the hook (122a) and the upper surface of the sensor cover (122), thereby preventing the sensor cover (122) from coming off.

[0134] The sensor support (122b) may be formed to protrude upward along the circumferential direction from the upper surface of the sensor cover (122). For example, the sensor support (122b) may be formed to protrude in the shape of a circular rib with the radial center of the sensor cover (122) as the origin. The sensor support (122b) may be formed to protrude so as to contact and support the lower surface of the biosensor (400). Thus, when the sensor cover (122) is coupled to the lower housing (120) and blocks the sensor insertion hole (121), the sensor support (122b) can contact and support the biosensor (400). Through this, the biosensor (400) is prevented from shaking, thereby preventing errors from occurring in the measurement value of the biosensor (400).

[0135] Meanwhile, referring to FIGS. 16 and 17, the process of a sensor cover (122) being coupled and fixed to a sensor insertion hole (121) is illustrated. At this time, a cover coupling guide part (123) is disposed in the lower housing (120), and a coupling guide groove (122c) may be formed on the lower surface of the sensor cover (122). The cover coupling guide part (123) is formed so that a user can intuitively recognize whether the coupling state of the sensor cover (122) is fixed or whether the sensor cover (122) is in a detachable state. For example, the cover coupling guide part (123) may be formed on the radial outer side of the sensor insertion hole (121), and an unlock indicator (123a) and a lock indicator (123b) may be disposed at a predetermined interval along the circumferential direction. At this time, a cover coupling part (121a) may be disposed on the radial inner side of the lock indicator (123b). Additionally, the coupling guide groove (122c) may be formed in the shape of a rectangular groove on the lower surface of the sensor cover (122). At this time, a hook (122a) may be positioned along the long axis direction (length direction) of the coupling guide groove (122c). Therefore, the user can separate the sensor cover (122) and the lower housing (120) by directing the longitudinal extension of the coupling guide groove (122c) toward the release indicator (123a). Furthermore, while the sensor cover (122) is blocking the sensor insertion hole (121), the user can lock the coupling state of the sensor cover (122) by rotating the sensor cover (122) so that the longitudinal extension of the coupling guide groove (122c) toward the lock indicator (123b).

[0136] With this configuration, the user can easily attach the sensor cover (122) and intuitively recognize and perform the method of locking or unlocking the attachment state.

[0137] Accordingly, according to the present invention, even when the user's proficiency is low, the biosensor (400) can be easily attached to and detached from the biosensor cartridge (1).

[0138] Meanwhile, a label (130) may be attached to the housing (100). The label (130) may be attached to the upper surface of the upper housing (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 injection location of the buffer solution, the injection location of the sample solution, and the direction of insertion into the diagnostic device (2).

[0139] With this configuration, there is an advantage that the biosensor cartridge (1) can be easily used even when the user's skill level is low.

[0140] Additionally, the label (130) may display a QR code containing sensor information, such as a product ID and a manufacturing serial number, for authenticating the product. The QR code may contain all sensor information for authenticating the product. For example, it may include not only the product ID and the manufacturing serial number, but also biosensor information and cartridge information. The biosensor information may include the detection substance activated in the biosensor (400), the disease to be diagnosed, the biosensor manufacturing date, the manufacturing location, and the manufacturing serial number. Additionally, the cartridge information may include the assembly date, inspection date, expiration date, and sensor ID of the biosensor cartridge (1). The QR code stored in this manner can be read from the QR reading module of the diagnostic device (2) to proceed with the authentication process to the cloud server. Through this authentication procedure, it is possible to verify errors containing risks regarding the biosensor cartridge (1) of the corresponding type.

[0141]

[0142] Meanwhile, FIG. 6 shows an exploded perspective view for explaining a frame according to one embodiment of the present invention, FIG. 7 shows a plan view for explaining a top frame according to one embodiment of the present invention, and FIG. 8 shows a cross-sectional view of a frame according to one embodiment of the present invention.

[0143] Referring to FIGS. 6 to 8, the frame (200) of a biosensor cartridge (1) and the tank (300) formed in the frame according to one embodiment of the present invention are described as follows.

[0144] A frame (200) is positioned inside a housing (100) and can form a channel (600) through which a buffer solution and a sample solution flow. Additionally, a biosensor (400) and a printed circuit board (500) are detachably coupled to the frame (200) so that the biosensor (400) can detect biomaterials in the sample solution flowing through the channel (600).

[0145] The frame (200) includes a base frame (210), a top frame (220), a hydrophilic adhesive layer (230), and a microchannel forming adhesive layer (240). At this time, the hydrophilic adhesive layer (230) may be laminated on the upper side of the base frame (210), the microchannel forming adhesive layer (240) may be laminated on the upper side of the hydrophilic adhesive layer (230), and the top frame (220) may be laminated on the upper side of the microchannel forming adhesive layer (240).

[0146] The base frame (210) can be detachably coupled to the biosensor (400). The base frame (210) can be coupled to the biosensor (400) to support the biosensor (400). For example, the base frame (210) may be formed in the shape of a roughly rectangular flat plate, and a sensor coupling part (211) coupled to the biosensor (400) may be formed.

[0147] The sensor coupling portion (211) may be positioned facing the sensor insertion hole (121). Specifically, the sensor coupling portion (211) may be positioned vertically above the sensor insertion hole (121). At this time, the sensor coupling portion (211) may be formed to have a diameter smaller than the diameter of the sensor insertion hole (121). Through this, the biosensor (400) can pass through the sensor insertion hole (121) and be separated or coupled.

[0148] The sensor coupling portion (211) can be detachably coupled to the biosensor (400). The sensor coupling portion (211) is formed in the shape of a hole corresponding to the overall shape of the biosensor (400), and a frame may be formed that crosses the hole along the short axis direction. A pair of ports (631, 632) may be formed in the frame. For example, the sensor coupling portion (211) may be formed in the shape of a square hole, and the front-rear diameter and left-right diameter may be formed to be equal to the front-rear length and left-right width of the biosensor (400).

[0149] Accordingly, the biosensor (400) can be fitted and coupled to the sensor coupling portion (211). Additionally, at least a portion of the side wall surrounding the sensor coupling portion (211) can be formed to be larger than the thickness of the biosensor (400). Thus, the biosensor (400) can be stably supported while fitted into the sensor coupling portion (211).

[0150] Meanwhile, a hole may be formed in the base frame (210) to fix the valve part (800) and the pump part (900). A fixing member, such as a screw, may pass through the hole and be coupled with the valve part (800) and the pump part (900) positioned on the upper side of the top frame (210).

[0151] A tank (300) may be formed on the top frame (220). Specifically, a tank (300) may be formed on the upper surface of the top frame (220). The tank (300) will be described later.

[0152] A channel (600) may be formed in the top frame (220). Specifically, a channel (600) may be formed on the lower surface of the top frame (220). The channel (600) will be described later.

[0153] At this time, the top frame (220) can be formed from a resin material. For example, the top frame (220) can be formed from PMMA (Polymethyl methacrylate) resin. Through this, it is possible to mass-produce while forming fine channels (600) through injection molding. In addition, there is an advantage that the top frame (220) and the base frame (210) can be easily bonded together using tape.

[0154] A substrate coupling portion (221) may be formed on the upper surface of the top frame (220). A printed circuit board (500) may be detachably coupled to the substrate coupling portion (221). A sensor coupling portion (211) may be disposed on one side of the frame (200), and a substrate coupling portion (221) may be disposed on the other side of the frame (200). At this time, the substrate coupling portion (221) may be positioned facing the sensor coupling portion (211) with the frame (200) in between. Specifically, at least a portion of the substrate coupling portion (221) may be disposed on the upper side of the sensor coupling portion (211). With such a configuration, the distance between the biosensor (400) and the printed circuit board (500) can be minimized. Accordingly, information detected by the biosensor (400) can be transmitted quickly and accurately to the printed circuit board (500).

[0155] The substrate coupling portion (221) may include a coupling guide portion (221a) that guides the slide coupling of the printed circuit board (500). The coupling guide portion (221a) may be formed by protruding a pair facing upward from the upper surface of the top frame (220), and then being bent and extended in a direction facing each other. At this time, the gap between the pair of coupling guide portions (221a) may be equal to the width of the printed circuit board (500). Accordingly, the pair of coupling guide portions (221a) can stably support the printed circuit board (500) to prevent the printed circuit board (500) from shaking in the horizontal direction. In addition, the protrusion height of the pair of coupling guide portions (221a) may be equal to or slightly larger than the thickness of the printed circuit board (500). Through this, the printed circuit board (500) can be prevented from moving in the vertical direction.

[0156] Additionally, the substrate coupling portion (221) may further include a substrate support portion (221b) that guides the coupling position of the printed circuit board (500) and supports the printed circuit board (500). A pair of substrate support portions (221b) may be formed protruding upward from the upper surface of the top frame (220). At this time, the substrate support portions (221b) may be formed corresponding to the shape of both ends in the width direction (short axis direction) of the printed circuit board (500). For example, if semicircular grooves are formed at both ends in the width direction of the printed circuit board (500), a pair of substrate support portions (221b) may be formed in a shape that protrudes in a semicircular manner toward the direction facing each other. Additionally, the shortest distance between a pair of substrate support portions (221b) may be formed to be the same as the shortest distance in the width direction of the printed circuit board (500). Through this, when the printed circuit board (500) is coupled, it can guide the coupling position by being fitted with the board support (221b) and prevent the printed circuit board (500) from moving along the insertion direction.

[0157] As a result, the substrate coupling portion (221) can prevent the printed circuit board (500) coupled through the coupling guide portion (221a) and the substrate support portion (221b) from shaking in the horizontal and vertical directions.

[0158] Accordingly, the substrate coupling portion (221) stably supports the coupled printed circuit board (500), thereby preventing errors in data from occurring as the printed circuit board (500) shakes.

[0159] Additionally, a clip receiving hole (221c) for receiving a contact clip (450) may be formed in the substrate coupling portion (221). A pair of clip receiving holes (221c) may be arranged on the substrate coupling portion (221). At this time, at least a portion of one of the pair of clip receiving holes (221c) may be placed between a pair of coupling guide portions (221a). Additionally, at least a portion of the other of the pair of clip receiving holes (221c) may be placed between a pair of substrate support portions (221b).

[0160] Through this, the contact clip (450) received in the clip receiving hole (221c) can be prevented from coming out of its designated position.

[0161] Additionally, a pair of clip receiving holes (221c) may be formed to communicate with the sensor coupling portion (211). At this time, at least a portion of each of the pair of clip receiving holes (221c) may be positioned facing the sensor coupling portion (211). For example, the sensor coupling portion (211) may be positioned between the pair of clip receiving holes (221c), such that a portion of both ends in the longitudinal direction (front-back direction) of the sensor coupling portion (211) overlaps with at least a portion of each of the pair of clip receiving holes (221c).

[0162] With this configuration, a base frame (210) and a top frame (220) can be stacked to form a stage to which a contact clip (450) is coupled. Additionally, there is an advantage that the contact clip (450) itself can directly contact the biosensor (400) and the printed circuit board (500). As a result, the accuracy of data transmission via the contact clip (450) can be improved in the biosensor cartridge (1) according to the present invention.

[0163] Meanwhile, a tube receiving portion (222) may be formed in the top frame (220). The tube receiving portion (222) may be formed to protrude upward from the upper surface of the top frame (220). The tube receiving portion (222) may guide the position where the tube (700) is placed on the top frame (220).

[0164] Specifically, the tube receiving portion (222) is formed to protrude in a block shape from the upper surface of the top frame (220), and a pump receiving groove (222a) and a tube guide groove (222b) may be formed inside.

[0165] The pump receiving groove (222a) may accommodate at least a portion of the tube (700) and the pump unit (900) inside. At this time, the tube (700) is arranged along the circumferential direction, and at least a portion of the pump unit (900) may be rotatably accommodated inside the wound tube (700). Additionally, at least a portion of the pump unit (900) may be placed within the pump receiving groove (222a) in contact with the tube (700). For example, the pump receiving groove (222a) may be formed in the shape of a circular groove, the tube (700) may be wound along the inner surface, and the pump unit (900) may be rotatably accommodated inside the tube (700).

[0166] With this configuration, when the pump unit (900) is rotated, the tube (700) placed between the side wall of the pump receiving groove (222a) and the pump unit (900) can be compressed.

[0167] The tube guide groove (222b) is formed to communicate with the pump receiving groove (222a) and can accommodate at least a portion of the tube (700). Specifically, the tube guide groove (222b) can accommodate one side and the other side of the tube (700) wound in the pump receiving groove (222a), respectively. At this time, the tube guide groove (222b) can accommodate the one side and the other side of the tube (700) so that they intersect each other. That is, the groove accommodating one side of the tube (700) and the groove accommodating the other side of the tube (700) can be joined together, and the joined point (222c) can be formed to communicate with the pump receiving groove (222a).

[0168] Through this, when the pump unit (900) rotates, at least a portion of the tube (700) can maintain contact with the pump unit (900). Therefore, backflow in the solution flowing through the tube (700) can be prevented when the pump unit (900) rotates.

[0169] Meanwhile, a valve coupling portion (223) may be formed on the top frame (220). The valve coupling portion (223) may be formed to protrude upward from the upper surface of the top frame (220). For example, the valve coupling portion (223) may be formed to protrude in a rib shape from the upper surface of the top frame (220). The valve coupling portion (223) may be formed to surround the outer side of at least a portion of the valve portion (800). Accordingly, the valve coupling portion (223) can guide the position where the valve portion (800) is coupled.

[0170] Meanwhile, a plurality of ports may be formed in the top frame (220). At this time, the ports may provide a space through which a buffer solution or a sample solution passes and flows into the channel (600), or through which the buffer solution or the sample solution is discharged from the channel (600). Specifically, a buffer solution inlet port (315), a buffer solution port (615), a sample solution port (625), a sensing port (635), a prefill port (645), a waste solution port (655), a first tube connection port (660), and a second tube connection port (670) may be formed in the top frame (220).

[0171] At this time, the buffer solution inlet port (315) is positioned within the buffer solution tank (310) to allow the buffer solution within the buffer solution tank (310) to flow into the channel (600).

[0172] Additionally, the buffer solution port (615), sample solution port (625), sensing port (635), and prefill port (645) may be arranged to be connected by the valve section (800). For example, the buffer solution port (615), sample solution port (625), and prefill port (645) may be arranged on concentric circles with the sensing port (635) as the origin. At this time, the buffer solution port (615), sample solution port (625), and prefill port (645) may be arranged with a predetermined angle difference with the sensing port (635) as the origin.

[0173] Additionally, the first tube connection port (660) and the second tube connection port (670) may be provided to be connected to the tube (700). At this time, the first tube connection port (660) and the second tube connection port (670) may be positioned adjacent to the pump unit (900). For example, the second tube connection port (670) may be positioned on one side in the longitudinal direction of the top frame (220) relative to the pump unit (900), and the first tube connection port (660) may be positioned on the other side in the longitudinal direction of the top frame (220) relative to the pump unit (900).

[0174]

[0175] Meanwhile, in the case of conventional biosensor cartridges, channels were formed inside the frame to allow liquid to flow, but there was a limitation in that the accuracy of sensing was low because the flow rate of the solution was not constant whenever a sample solution was tested.

[0176] To address this, hydrophilic coatings were applied to the base frame; however, while the addition of the coating process increased production costs, it had the disadvantage of raising the defect rate due to coating non-uniformity.

[0177] Accordingly, in the present invention, the flow rate of the solution can be maintained constant through the hydrophilic adhesive layer (230), while minimizing the increase in production costs and the defect rate.

[0178] A hydrophilic adhesive layer (230) may be placed between the base frame (210) and the top frame (220). A hydrophilic adhesive layer (230) may be placed between the base frame (210) and the microchannel 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) may be placed on the upper side of the base frame (210) to facilitate the flow of fluid flowing through the channel (600). Thus, the hydrophilic adhesive layer (230) has the effect of stably maintaining the flow rate of the solution.

[0179] In addition, there is an advantage that bonding is possible through a simple process of placing a hydrophilic adhesive layer (230), a micro-channel forming adhesive layer (240), and a top frame (220) on the upper side of a base frame (210) and applying pressure, without a separate heating process during the manufacturing process.

[0180] A shape corresponding to the shape of the top frame (220) may be formed in the hydrophilic adhesive layer (230). For example, a clip receiving hole (231) may be formed in the hydrophilic adhesive layer (230). The clip receiving hole (231) of the hydrophilic adhesive layer (230) may be formed in a position facing the clip receiving hole (221c) of the top frame (220) and may be formed in a shape of the same size.

[0181] Additionally, the hydrophilic adhesive layer (230) may be formed with a shape corresponding to the shape of the base frame (210). For example, a port may be formed in the hydrophilic adhesive layer (230). The port of the hydrophilic adhesive layer (230) may be formed in a position facing the port (631a, 632a) of the base frame (210) and may be formed in a shape of the same size.

[0182]

[0183] A microchannel forming adhesive layer (240) can be placed between a hydrophilic adhesive layer (230) and a top frame (220). The microchannel forming adhesive layer (240) can bond the hydrophilic adhesive layer (230) and the top frame (220). At this time, the microchannel forming adhesive layer (240) can be formed with a shape corresponding to the shape of the top frame (220).

[0184] Specifically, the micro-channel forming adhesive layer (240) may have a channel slit (242) formed in communication with the channel (600) formed in the top frame (220). The channel slit (242) may be formed at a position facing the channel (600). At this time, the width of the channel slit (242) may be formed to be larger than the width of the channel (600). With this configuration, even if an error occurs in the position of the channel (600) and the channel slit (242), an error in the flow of the solution can be prevented.

[0185] Additionally, a clip receiving hole (241) may be formed in the micro-channel forming adhesive layer (240). The clip receiving hole (241) of the micro-channel forming adhesive layer (240) may be formed in a position facing the clip receiving hole (221c) of the top frame (220) and may be formed in the same size.

[0186]

[0187] A tank (300) is formed on the upper surface of the frame (200) and can provide a space in which a buffer solution and / or a sample solution can be received. For example, the tank (300) may be formed by protruding from the upper surface of the top frame (220) and forming a shape that surrounds a predetermined space.

[0188] The tank (300) may include a buffer solution tank (310). The buffer solution tank (310) may receive a buffer solution, at least temporarily contain the buffer solution, and allow the buffer solution to flow into a channel (600).

[0189] The buffer solution tank (310) may be positioned on the rear side (one side in the longitudinal direction) of the frame (200). The buffer solution tank (310) may be positioned on the opposite side of the substrate coupling portion (221) on the frame (200).

[0190] Additionally, the buffer solution tank (310) may be placed on the left side (one side in the short direction) of the frame (200). The buffer solution tank (310) may be placed on the opposite side of the waste solution tank (330) on the frame (200).

[0191] The buffer solution tank (310) may be formed protruding in the form of a wall on the upper side of the top frame (220). For example, the buffer solution tank (310) may be formed protruding in the form of a square wall. At this time, a buffer solution inlet port (315) may be formed in the top frame (220), and the buffer solution inlet port (315) may be formed to communicate with the buffer solution channel (610). The buffer solution inlet port (315) may be formed within the buffer solution tank (310). Additionally, an inclined surface (311) and a guide groove may be formed within the buffer solution tank (310) to guide the buffer solution to flow into the buffer solution inlet port (315). For example, the inclined surface may be formed to slope downward from the rear end of the buffer solution tank (310) toward the front. Along with this, the inclined surface may be formed to slope downward from both sides in the left and right directions toward the center in the left and right directions. Accordingly, a guide groove may be formed along the front-rear direction on the inner bottom surface of the buffer solution tank (310). And, a buffer solution inlet port (315) may be formed on the guide groove.

[0192] Accordingly, the buffer solution tank (310) can surround the perimeter of the space into which the buffer solution is introduced. Accordingly, the buffer solution can be contained in the buffer solution tank (310), and the buffer solution can be discharged into the channel (600) according to the operation of the pump unit (900).

[0193] The tank (300) may include a sample solution tank (320). The sample solution tank (320) may receive a sample solution, at least temporarily receive the sample solution, and allow the sample solution to flow into a channel (600).

[0194] The sample solution tank (320) may be placed on the rear side of the frame (200). The sample solution tank (320) may be placed on the opposite side of the substrate coupling portion (221) on the frame (200).

[0195] Additionally, at least a portion of the sample solution tank (320) may be positioned in the left-right central part of the frame (200). The sample solution tank (320) may be positioned between the buffer solution tank (310) and the waste solution tank (330).

[0196] The sample solution tank (320) may be formed to protrude in the form of a wall from the upper side of the top frame (220). For example, the sample solution tank (320) may be formed to protrude in the form of a circular wall. In this case, the top frame (220) may be formed such that at least a portion of the lower side of the internal space of the sample solution tank (320) is open. The internal space of the sample solution tank (320) may be formed to communicate with the sample solution channel (620).

[0197] Accordingly, the sample solution tank (320) can surround the perimeter of the space into which the sample solution is introduced. Accordingly, the sample solution can be contained in the sample solution tank (320), and the sample solution can be discharged into the channel (600) according to the operation of the pump unit (900).

[0198] The tank (300) may include a waste solution tank (330). The waste solution tank (330) may receive waste solution and store waste solution.

[0199] The waste solution tank (330) may be placed on the rear side of the frame (200). The waste solution tank (330) may be placed on the opposite side of the substrate coupling part (221) on the frame (200).

[0200] Additionally, the waste solution tank (330) can be placed on the right side of the frame (200).

[0201] The waste solution tank (330) may be formed protruding in the form of a wall on the upper side of the top frame (220). For example, the waste solution tank (330) may be formed protruding in the form of a square wall. At this time, a waste solution port (655) may be formed in the top frame (220), and the waste solution port (655) may be formed to communicate with the waste solution channel (650). The waste solution port (655) may be formed within the waste solution tank (330).

[0202] Accordingly, the waste solution tank (330) can surround the perimeter of the space into which the waste solution flows. Accordingly, the waste solution can flow from the channel (600) into the waste solution tank (330) and be stored according to the operation of the pump unit (900).

[0203]

[0204] Meanwhile, FIG. 9 shows a bottom view illustrating a channel formed in a top frame according to one embodiment of the present invention.

[0205] Referring to FIG. 9, the channel (600) of the biosensor cartridge (1) according to one embodiment of the present invention is described as follows.

[0206] A channel (600) is formed inside the frame (200) and can provide a flow path through which a buffer solution or sample solution can be agitated. Specifically, the channel (600) can be formed on the lower side of the top frame (220).

[0207] The channel (600) is connected to the buffer solution tank (310) and includes a buffer solution channel (610) through which the buffer solution flows. Specifically, one side of the buffer solution channel (610) may be in communication with a buffer solution inlet port (315). Thus, one side of the buffer solution channel (610) may be in communication with 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) may be in communication with a buffer solution port (615). The other side of the buffer solution channel (610) may be in communication with a sensing channel (630) through the buffer solution port (615) depending on the operation of the valve section (800).

[0208] The buffer solution channel (610) can guide the buffer solution introduced into the buffer solution tank (310) to the valve section (800). For example, the buffer solution channel (610) may be formed along the longitudinal direction (long 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 is bent at least once at a predetermined angle. For example, the buffer solution channel (610) may be formed along the longitudinal direction (long axis direction) of the frame (200) in its entirety, but may have a portion that is bent twice.

[0209] Meanwhile, the buffer solution inlet port (315) can serve as an inlet for the buffer solution channel (610), and the buffer solution port (615) can serve as an outlet for the buffer solution channel (610).

[0210] At this time, the buffer solution channel (610) may be formed with a width on the inlet side and a width on the outlet side that are different. For example, the buffer solution channel (610) may be formed with a width on the outlet side that is larger than the width on the inlet side. Through this, the buffer solution can be sufficiently present on the outlet side of the buffer solution channel (610), and the flow rate of the buffer solution passing through the valve section (800) can be prevented from decreasing. Therefore, there is an effect of maintaining a stable flow rate of the buffer solution.

[0211] The channel (600) includes a sample solution channel (620) through which the sample solution flows, which is connected to the sample solution tank (320). Specifically, one side of the sample solution channel (620) may be in communication with the internal space of the sample solution tank (320). Additionally, the other side of the sample solution channel (620) may be in communication with the sample solution port (625). The other side of the sample solution channel (620) may be in communication with the sensing channel (630) through the sample solution port (625) according to the operation of the valve section (800).

[0212] The sample solution channel (620) can guide the sample solution introduced into the sample solution tank (320) to the valve section (800). For example, the sample solution channel (620) can be formed along a direction intersecting the longitudinal direction (long axis direction) of the frame (200) from the sample solution tank (320), then folded to form along the longitudinal direction of the frame (200), and subsequently folded to form along a direction intersecting the longitudinal direction. Thus, the internal space of the sample solution tank (320) can serve as an inlet for the sample solution channel (620), and the sample solution port (625) can serve as an outlet for the sample solution channel (620).

[0213] Meanwhile, the internal space of the sample solution tank (320) can serve as an inlet for the sample solution channel (620), and the sample solution port (625) can serve as an outlet for the sample solution channel (620).

[0214] At this time, the diameter of the internal space of the sample solution tank (320) may be formed to be larger than the width of the discharge side of the sample solution channel (620). Additionally, the width of at least a portion of the sample solution channel (620) may be changed. For example, the sample solution channel (620) may be formed such that the width of the inlet side and the width of the discharge side are the same, while having a section where the width narrows in between.

[0215] Through this, it is possible to prevent the flow rate of the sample solution flowing through the sample solution channel (620) from decreasing instantaneously depending on the operation of the pump unit (900). Therefore, there is an effect of maintaining the flow rate of the sample solution stably.

[0216] The channel (600) may include a sensing channel (630) that is connected to a buffer solution channel (610) or a sample solution channel (620) and guides the buffer solution or sample solution to the biosensor (400). Specifically, one side of the sensing channel (630) may be in communication with a sensing port (635). Additionally, the other side of the sensing channel (630) may be in communication with a first tube connection port (660). The other side of the sensing channel (630) may be in communication with a flow path formed inside the tube (700) through the first tube connection port (660) according to the operation of the valve part (800).

[0217] The sensing channel (630) can guide the buffer solution or sample solution introduced through the valve section (800) to the biosensor (400) and allow 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).

[0218] 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, the first sensing channel (631) can be formed along the length direction (long axis direction) of the frame (200) from the sensing channel (630), then folded to form along a direction intersecting the length direction. As an example, the first sensing channel (631) can be formed along the width direction by being formed along the length direction (long axis direction) of the frame (200) from the sensing port (635), then folded. The other side of the first sensing channel (631) can be in communication with the internal space of the sensor coupling section (211). Specifically, the first sensing channel (631) can flow the buffer solution or sample solution into the internal space of the sensor coupling section (211) through the inlet port (631a) formed in the base frame (210).

[0219] With this configuration, the buffer solution or sample solution that has passed through the first sensing channel (631) can flow on the upper surface of the biosensor (400).

[0220] Meanwhile, the sensing port (635) can serve as an inlet for the first sensing channel (631), and the sensor coupling part (211) can serve as an outlet for the first sensing channel (631).

[0221] At this time, the width of the inlet side of the first sensing channel (631) can be formed to be larger than the width of the outlet side of the first sensing channel (631). Through this, the buffer solution or sample solution can be sufficiently present on the inlet side of the first sensing channel (631), and the flow rate of the buffer solution or sample solution flowing through the first sensing channel (631) instantaneously according to the operation of the pump unit (900) can be prevented from decreasing. Therefore, there is an effect that the flow rate of the buffer solution or sample solution can be stably maintained.

[0222] Additionally, 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) may be connected to the discharge port (632a) formed in the base frame (210) and may be connected to the first tube connection port (660) formed along the left and right directions. At this time, the second sensing channel (632) may be positioned in a straight line with the downstream side of the first sensing channel (631). With such a configuration, the flow path passing through the biosensor (400) can be formed in a straight line, and the flow rate and / or flow rate of the buffer solution or sample solution flowing through the biosensor (400) can be stably maintained. Accordingly, the biosensor cartridge (1) of the present invention can increase the sensing accuracy for biomaterials.

[0223] The channel (600) may include a prefill channel (640) through which the sample solution flows, which is in communication with the sample solution channel (620). Specifically, one side of the prefill channel (640) may be in communication with the sample solution channel (620). Additionally, one side of the prefill channel (640) may be in communication with the sample solution port (625). Additionally, the other side of the prefill channel (640) may be in communication with the prefill port (645).

[0224] The prefill channel (640) can guide the sample solution that has passed through the sample solution channel (620) to the prefill port (645). For example, the prefill channel (640) is formed to communicate with the sample solution channel (620) and can be formed by bending it multiple times to communicate with the prefill port (645).

[0225] At this time, the width of at least a portion of the prefill channel (640) may be changed. For example, the prefill channel (640) may be formed such that the width of the inlet side and the width of the outlet side are the same, but there is a section in between where the width narrows.

[0226] Additionally, the prefill channel (640) may be equipped with a valve (641) formed to be wider than the inlet and outlet. The valve (641) may be formed to be the widest in the prefill channel (640), while the width of the inlet entering the valve (641) may be formed to be the narrowest in the prefill channel (640). Through this, when a large amount of sample solution is instantaneously introduced into the prefill channel (640), the sample solution may be prevented from being discharged into the prefill port (645).

[0227] The channel (600) may include a waste solution channel (650) that guides the buffer solution or sample solution passing through the tube (700) to the waste solution tank (330). Specifically, one side of the waste solution channel (650) may be in communication with a second tube connection port (670). Additionally, the other side of the waste solution channel (650) may be in communication with a waste solution port (655). Thus, when the pump unit (900) is operated, the buffer solution or sample solution passing through the tube (700) can be stored in the waste solution tank (330).

[0228]

[0229] Meanwhile, FIG. 10 illustrates a diagram for explaining the coupling of a biosensor and a printed circuit board to a frame in a biosensor cartridge according to an embodiment of the present invention, FIG. 11 illustrates a diagram for explaining a sensor coupling part in a biosensor cartridge according to an embodiment of the present invention, FIG. 12 illustrates a diagram for explaining the state in which a biosensor is coupled in a biosensor cartridge according to an embodiment of the present invention, FIG. 13 illustrates a cross-sectional view for explaining the contact between a biosensor and a printed circuit board in a biosensor cartridge according to an embodiment of the present invention, FIG. 14 and FIG. 15 illustrate cross-sectional views for explaining the arrangement of a biosensor and a printed circuit board and the arrangement of a flow path flowing over the biosensor in a biosensor cartridge according to an embodiment of the present invention.

[0230] Referring to FIGS. 10 to 15, the biosensor (400), contact clip (450), and printed circuit board (500) of the biosensor cartridge (1) according to one embodiment of the present invention are described as follows.

[0231] The biosensor (400) is detachably coupled to the frame (200) and can detect biomaterials. The biosensor (400) can be inserted through the sensor insertion hole (121) of the lower housing (120), and the biosensor (400) can be coupled to the sensor coupling part (211) of the base frame (210).

[0232] A biosensor (400) can selectively detect a minute amount of biomaterial to be analyzed by combining a bioreceptor having a recognition function for a specific biomaterial with an electrical transducer to convert biological interactions and recognition responses into electrical signals.

[0233] The biosensor (400) of the present invention may be an electrochemical-based biosensor. An electrochemical-based biosensor combines the analytical capability of an electrochemical method with the specificity of biological recognition, and detects the biological recognition phenomenon of a target substance as a change in current or potential by immobilizing or containing a substance having biological specificity, such as an enzyme, antigen, antibody, or biochemical substance, on the electrode surface.

[0234] For example, a sensing portion may be provided on the upper surface of the biosensor (400). A bio-receptor may be placed in the sensing portion. A buffer solution and a sample solution may flow through the sensing portion. The sensing portion may be connected to a circuit to transmit an electrical signal generated in the sensing portion.

[0235] A circuit may be placed on the biosensor (400) and may be electrically connected to the printed circuit board (500) by a contact clip (450).

[0236] A biosensor (400) according to one embodiment of the present invention comprises a graphene-based field effect transistor (FET) using a graphene layer as a channel.

[0237] The biosensor (400) includes a substrate, a source electrode and a drain electrode spaced apart from each other on the substrate, 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.

[0238] Meanwhile, the biosensor (400) may further include an insulating layer disposed on a substrate.

[0239] The source electrode, drain electrode, and graphene layer can be disposed on an insulating layer. Accordingly, the sensing sensitivity of the graphene-based sensor can be improved.

[0240] The substrate, as a semiconductor substrate, may be a silicon substrate. The insulating layer on the substrate may be formed of silicon oxide (SiO2) or silicon nitride. As an example, a silicon oxide-based insulating layer may be formed on the surface through heat treatment. Meanwhile, a graphene layer is formed on the insulating layer.

[0241] For sensing, some regions of the graphene layer are left open, while other regions are covered by a doping layer.

[0242] Meanwhile, the graphene layer may be formed in multiple places within the biosensor (400). The graphene layer may be formed in a part of the insulating layer. Meanwhile, the source electrode and the drain electrode may be spaced apart from each other and formed on a part of the insulating layer and the graphene layer.

[0243] The sample solution can be in contact with an open region of the graphene layer of the biosensor (400) and a part of the gate electrode.

[0244] Meanwhile, a linker material may be attached to ensure a smooth connection between the sensing material and the graphene layer. The linker material may vary depending on the graphene layer and the sensing material.

[0245] When the graphene layer is a polymer structure having a nanoscale, the linker material may be composed of at least one of polyurethane, polydimethylsiloxane, NOA (Norland Optical Adhesives), epoxy, polyethylene terephthalate, polymethyl methacrylate, polyimide, polystyrene, polyethylene naphthalate, polycarbonate, and combinations thereof.

[0246] In addition, the linker material may be composed of a combination of polyurethane and NOA (e.g., NOA 68). However, the linker material is not limited to this and may be composed of various flexible polymers.

[0247] Meanwhile, when a sample solution is introduced and a corresponding voltage is applied to the source electrode, drain electrode, and gate electrode, respectively, if a target substance is present in the sample solution, the graphene layer becomes charged with a specific carrier as the target substance reacts with the sensing substance. Accordingly, a depletion state in which charge accumulates in the graphene layer proceeds, and the drain current flowing through the drain electrode increases.

[0248] Meanwhile, when a sample solution is introduced and the corresponding voltage is applied to the source electrode, drain electrode, and gate electrode, respectively, if there is no target substance in the sample solution, the drain current flowing through the drain electrode flows at a significantly lower level than the drain current when the target substance is present.

[0249] Meanwhile, the sample solution may refer to a solution diluted with biological material such as saliva, body fluids including sweat, blood, serum, or plasma.

[0250]

[0251] A sealer (410) may be disposed on the upper side of the biosensor (400). The sealer (410) may be disposed on the sensor coupling portion (211). A flow path forming portion (411) may be formed in the sealer (410). For example, the sealer (410) may be formed in the shape of a rectangular parallelepiped, and the flow path forming portion (411) may be in the shape of a slit formed along the left and right directions.

[0252] At this time, the flow path forming part (411) may be positioned on the lower side of the frame formed in the sensor coupling part (211). Specifically, the flow path forming part (411) may be positioned on the lower side of the inlet port (631a) and the outlet port (632a) formed in the sensor coupling part (211), and may be in communication with the inlet port (631a) and the outlet port (632a). With this configuration, the buffer solution and sample solution flowing through the first sensing channel (631) may flow through the flow path inside the flow path forming part (411) via the inlet port (631a), pass through the outlet port (632a), and be introduced into the second sensing channel (632).

[0253] Additionally, the flow path forming part (411) may be positioned above the sensing part of the biosensor (400). At this time, the sealer (410) may be formed to surround the outer edge of the sensing part. The sealer (410) seals the outer edge of the flow path forming part (411) to prevent the buffer solution and sample solution flowing inside the flow path forming part (411) from leaking out.

[0254] The printed circuit board (500) can be detachably coupled to the frame (200). At least a portion of the biosensor (400) can be inserted into the upper housing (110) and detachably coupled to the substrate coupling portion (221) of the top frame (220). The printed circuit board (500) can be supported by the coupling guide portion (221a) and the substrate support portion (221b).

[0255] Specifically, the printed circuit board (500) may include a board body (510), a connector (520), and a guide portion (530). For example, the board body (510) may be formed in the shape of a roughly rectangular flat plate. A circuit may be mounted on the board body (510) and electrically connected to the biosensor (400).

[0256] Meanwhile, a connector (520) may be provided at the front end of the substrate body (510). The connector (520) may be connected to a circuit provided in the substrate body (510). Thus, when the biosensor cartridge (1) is coupled to the diagnostic device (2), an electrical signal can be transmitted to the diagnostic device (2) through the connector (520). Additionally, when the biosensor cartridge (1) is coupled to the diagnostic device (2), power can be applied to the printed circuit board (500) and the biosensor (400) through the connector (520).

[0257] The guide portion (530) can be formed at both ends of the substrate body (510) in the left and right directions and can be coupled with the substrate support portion (221b) of the substrate coupling portion (221). For example, the guide portion (530) can be formed as a recessed curved shape at both ends of the substrate body (510) in the left and right directions. Through this, it can be coupled with the protruding shape of the substrate support portion (221b) to guide the accurate coupling position of the printed circuit board (500) and stably support the printed circuit board (500) in the coupled state.

[0258] Meanwhile, 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 may come into contact with the printed circuit board (500) and the biosensor (400). Additionally, the contact clip (450) may be disposed to pass through the clip receiving hole (221c) and to pass through the hole of the sensor coupling portion (211), while at least a portion may be supported by the base frame (210).

[0259] 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) may be arranged side by side, and one pair may be symmetrically arranged in a position facing each other. For example, six contact clips (450) may be provided, and three pairs may be arranged side by side, and each pair may be symmetrically arranged in a position facing each other.

[0260] Specifically, the contact clip (450) may be formed of a conductive material. For example, the contact clip (450) may be formed of a metal material. Each contact clip (450) may include a substrate contact portion (451), a sensor contact portion (452), and a connection portion (453).

[0261] The substrate contact portion (451) may be positioned to pass through the clip receiving hole (221c). At this time, the substrate contact portion (451) may come into contact with a terminal (not shown) provided on the printed circuit board (500). That is, the substrate contact portion (451) may be electrically connected to a circuit mounted on the printed circuit board (500). For example, the substrate contact portion (451) may be in the form of a plate extending along the front-rear direction.

[0262] The sensor contact portion (452) is positioned to pass through a hole formed in the sensor coupling portion (211) and can come into contact with a terminal (not shown) provided in the biosensor (400). That is, the sensor contact portion (452) can be electrically connected to a circuit mounted on the biosensor (400). For example, the sensor contact portion (452) may be in the form of a plate that is formed extending downward from the coupling portion (453), then folded and extended upward.

[0263] At this time, the total height of the contact clip (450) in the vertical direction can be formed to be longer than the shortest distance between the biosensor (400) and the printed circuit board (500).

[0264] With this configuration, when the sensor contact portion (452) comes into contact with the biosensor (400), the sensor contact portion (452) can apply pressure to the biosensor (400) while elastically deforming, and can maintain a strong contact state while minimizing the contact area with the biosensor (400).

[0265] The connecting portion (453) may be formed to connect the substrate contact portion (451) and the sensor contact portion (452). At this time, the connecting portion (453) is formed by bending and extending downward from the substrate contact portion (451), and then is bent and extended along the front-rear direction, and can be connected to the sensor contact portion (452) by bending and extending downward. The connecting portion (453) may be supported by contacting the base frame (210).

[0266] Therefore, the contact clip (450) is seated on the frame (200), so that the upper side is in contact with the printed circuit board and the lower side is in contact with the biosensor (400). Thus, while allowing the buffer solution and sample solution to flow between the printed circuit board (500) and the biosensor (400) through the contact clip (450), the electrical signal generated from the biosensor (400) can be transmitted to the printed circuit board over the shortest distance.

[0267]

[0268] Meanwhile, FIG. 18 shows an exploded perspective view for explaining the valve section and the pump section in a biosensor cartridge according to one embodiment of the present invention, FIG. 19 shows an exploded perspective view for explaining the valve section in a biosensor cartridge according to one embodiment of the present invention, FIG. 20 shows a perspective view for explaining the channel plate of the valve section in a biosensor cartridge according to one embodiment of the present invention, FIG. 21 shows a bottom view for explaining the pump section in a biosensor cartridge according to one embodiment of the present invention, and FIG. 22 shows a diagram for explaining the process of compressing a tube according to the rotation of the pump section in a biosensor cartridge according to one embodiment of the present invention.

[0269] Referring to FIGS. 18 to 22, the tube (700), valve part (800), and pump part (900) of a biosensor cartridge (1) according to one embodiment of the present invention are described as follows.

[0270] The tube (700) is connected to the channel (600) and can flow a buffer solution or a sample solution. The tube (700) is formed of a flexible material and has a flow path formed inside through which fluid can flow.

[0271] One end of the tube (700) can be connected to a first tube connection port (660), and the other end of the tube (700) can be connected to a second tube connection port (670). Through this, one side of the tube (700) can be connected to a sensing channel (630), and the other side of the tube (700) can be connected to a waste solution channel (650). Accordingly, the tube (700) can receive a buffer solution or sample solution that has passed through the sensing channel (630) and discharge the buffer solution or sample solution to the waste solution channel (650).

[0272] The tube (700) can be coupled to the tube receiving portion (222). Specifically, the tube (700) can be positioned along the inner circumference of the pump receiving groove (221a) to wrap around at least a portion of the pump knob (910). At this time, a portion of the tube (700) can be elastically deformed by being pressed between the pump knob (910) and the inner circumference of the pump receiving groove (221a). Thus, when the pump knob (910) is rotated, the tube (700) is sequentially pressed along the circumference, allowing the buffer solution or sample solution inside to flow. Additionally, as the buffer solution or sample solution within the tube (700) flows, negative pressure is formed in the sensing channel (630), causing the buffer solution or sample solution to flow in. Then, the buffer solution or sample solution can be discharged into the waste solution channel (650) to discharge the buffer solution or sample solution into the waste solution tank (330).

[0273] Meanwhile, in a conventional structure in which fluid is flowed by pressing the tube according to the rotation of the pump, even if the inlet side and the discharge side are positioned close together, the tube bends sharply in the region just before the tube is wound in a circle, and since the inlet side and the discharge side bend in opposite directions, a region is created in which the tube cannot be pressed while the pump rotates 360 degrees.

[0274] In this case, as the tube compressed by the pump is instantaneously restored, backflow occurs in the fluid flowing through the tube. Consequently, there is a problem of backflow occurring in the entire fluid path. In particular, when the flow rate of a buffer solution or sample solution must be maintained stably, such as in a biosensor cartridge, there is a problem that errors may occur in the measurement values.

[0275] To solve this, in the present invention, a tube (700) is arranged along the circumferential direction to surround the pump knob (910), with the inlet side and the discharge side intersecting each other. In this case, either the inlet side or the discharge side of the tube (700) may be stacked on top of the other. With this configuration, the tube (700) can completely surround the pump knob (910) at least once, and prevent the buffer solution or sample solution from flowing back while the pump knob (910) is rotating.

[0276] Specifically, one side and the other side in the longitudinal direction of the tube (700) can be received in the tube guide groove (222b), respectively. At this time, the tube guide groove (222b) can be formed so that the groove receiving one side of the tube (700) and the groove receiving the other side of the tube (700) merge into one and communicate with the pump receiving groove (222a). Then, the one side and the other side of the tube (700) can be received in a stacked state in the tube guide groove (222b) that has merged into one.

[0277] Accordingly, according to the present invention, the tube (700) is wound at least once so that the flow rate and flow velocity of the buffer solution and / or sample solution can be stably maintained during the operation of the pump unit (900).

[0278]

[0279] The valve part (800) can be rotatably coupled to the frame (200).

[0280] Specifically, the valve section (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 accommodated inside the valve housing (810), and the channel plate (830) can be coupled to the lower side of the valve knob (820).

[0281] The valve portion (800) can be coupled to the upper side of the top frame (220). Specifically, the valve housing (810) can be coupled to the valve coupling portion (223). At this time, the valve housing (810) can be fixed to the frame (200) by being coupled with a fixing member such as a screw. At this time, the fixing member can be coupled to the valve housing (810) by penetrating the base frame (210) and the top frame (220).

[0282] For example, the valve housing (810) may include a fixing part (811) coupled to the upper side of the top frame (220) and a supporting part (812) extending upward from the fixing part. In this case, the fixing part (811) may be formed in the shape of a hollow circular block, and a fixing member receiving part may be formed that extends radially outward to be coupled with a fixing member. Additionally, a knob receiving hole having a predetermined inner diameter may be formed at the radial center of the fixing part (811). On the other hand, the supporting part (812) may be formed in a cylindrical shape, and the inner diameter of the supporting part (812) may be formed smaller than the inner diameter of the knob receiving hole of the fixing part (811). That is, the inner surface of the valve housing (810) may be formed to form a step.

[0283] The valve knob (820) may be provided to rotate when an external force is applied.

[0284] At least a portion of the valve knob (820) may be rotatably received in the valve housing (810). For example, the valve knob (820) may be formed in a cylindrical shape, and the outer surface of the valve knob (820) may be formed to form 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) is formed to be larger than the outer diameter of the small diameter portion (822), and the large diameter portion (821) may be positioned lower than the small diameter portion (822). Additionally, the large diameter portion (821) may be received in the fixed portion (811) of the valve housing, and the small diameter portion (822) may be received in the support portion (812) of the valve housing.

[0285] Through this, the valve knob (820) can be prevented from moving along the axial direction. As a result, the axial (up and down) movement of the channel plate (830) positioned below the valve knob (820) is restricted, and the flow rate of the buffer solution or sample solution flowing along the flow path formed in the channel plate (830) can be stably maintained.

[0286] Meanwhile, a knob groove (823) may be formed in the valve knob (820) so that an external force can be applied. When the biosensor cartridge (1) is coupled to the diagnostic device (2), the knob groove (823) may be coupled to the valve actuator (24) provided in the diagnostic device (2). At this time, the knob groove (823) may be formed to guide the initial position when the valve knob (820) is rotated. For example, the knob groove (823) may be formed with an uneven diameter. Accordingly, the knob groove (823) may be key-coupled to the valve actuator (24). With this configuration, the knob groove (823) and the valve actuator (24) can be coupled in the correct position.

[0287] Meanwhile, the channel plate (830) is coupled to the lower side of the valve knob (820) and can rotate together with the rotation of the valve knob (820). Specifically, the channel plate (830) may include a plate body (831) and a coupling guide hole (832). For example, the plate body (831) may be formed in the shape of a disc and coupled to the lower end of the valve knob (820). At this time, at least one coupling projection (not shown) may be formed protruding from the lower surface of the valve knob (820). Along with this, a coupling guide hole (832) may be formed in the plate body (831) at a position facing the coupling projection.

[0288] With this configuration, when the coupling projection of the valve knob (820) and the coupling guide hole (832) are coupled, the valve knob (820) and the channel plate (830) can rotate in conjunction. Additionally, there is an advantage in that the position of the connecting channel (833), which will be described later, can be determined through the degree to which the knob groove (823) is rotated.

[0289] A connecting channel (833) may be formed in the channel plate (830). The connecting channel (833) is formed on the lower surface of the channel plate (830) and can connect at least two ports formed in the top frame (220) to each other according to the rotation of the channel plate (830). For example, the connecting channel (833) may be formed as a recess similar to a dumbbell shape. Through this, a buffer solution or sample solution can be sufficiently introduced and discharged, and a stable flow rate and flow velocity can be provided.

[0290] The connection channel (833) may be formed to connect at least two of the buffer solution port (615), sample solution port (625), sensing port (635), and prefill port (645) to each other. In one example, the connection channel (833) may be formed as a single channel, with one side communicating with the sensing port (635) and the other side communicating with any one of the buffer solution port (615), sample solution port (625), and prefill port (645) depending on the rotation of the channel plate (830). In another example, the connection channel (833) may be formed as two channels, communicating with the buffer solution port (615), sample solution port (625), sensing port (635), and prefill port (645), respectively, but the connected port may change depending on the rotation of the channel plate (830).

[0291] Accordingly, the sensing port (635) can be connected to any one of the buffer solution port (615), sample solution port (625), and prefill port (645) by the connection channel (833), and when the pump unit (900) is operated, the buffer solution or sample solution can be introduced into the sensing port (635).

[0292] Therefore, the valve knob (820) can open and close the channel (600) to selectively flow the buffer solution or sample solution into the biosensor (400) depending on the rotation.

[0293]

[0294] The pump unit (900) is rotatably coupled to the frame (200) and, as it rotates, pressurizes the tube (700) to generate a flow force in the buffer solution or sample solution flowing through the channel (600).

[0295] The pump unit (900) may include a pump knob (910) and a bearing (920).

[0296] The pump knob (910) can be positioned on the upper surface of the top frame (220). The pump knob (910) can be rotatably coupled within the tube receiving portion (222). The pump knob (910) can be rotatably received within the pump receiving groove (222a).

[0297] Specifically, the pump knob (910) includes a shaft (911), a support member (912), and a drive groove (913). The shaft (911) is formed in a cylindrical shape and provides the rotation axis of the pump knob (910). At this time, the radius from the rotation axis to the outer surface of the shaft (911) is formed to be non-uniform. That is, a cam (911a) can be formed on the shaft (911) at the largest radius from the rotation axis. Therefore, since the shaft (911) has an outer surface in the shape of a cam, the position where the tube (700) is pressed can be changed according to the rotation of the shaft (911).

[0298] The support member (912) is positioned on the upper part of the shaft (911) and can be positioned on the lower side of the upper housing (110).

[0299] The support member (912) can be formed in the shape of a circular block. The support member (912) can be formed integrally with the shaft (911). Therefore, the support member (912) and the shaft (911) can rotate together.

[0300] The outer diameter of the support member (912) may be formed to be larger than the maximum outer diameter of the shaft (911). At this time, the diameter of the support member (912) may be larger than the diameter of the combined state of the shaft (911), the bearing (920) surrounding the outer surface of the shaft, and the tube (700) surrounding the outer surface of the bearing (920). For example, the diameter of the support member (912) may be equal to the diameter of the pump receiving groove (222a).

[0301] Through this, the support member (912) can prevent the bearing (920) or tube (700) from coming out of the pump receiving groove (222a) when the shaft (911) rotates.

[0302] Additionally, the support member (912) is in contact with the upper housing (110) to prevent the shaft (911) from shaking when an external rotational force is applied to the shaft (911).

[0303] The driving groove (913) may be positioned on the upper part of the support member (912). The driving groove (913) may be formed to allow external force to be applied. When the biosensor cartridge (1) is coupled to the diagnostic device (2), the driving groove (913) may be coupled to the pump actuator (25) provided in the diagnostic device (2). The driving groove (913) may be formed corresponding to the shape of the pump actuator (25). For example, the driving groove (913) may be formed in the shape of a cross groove.

[0304] Therefore, after the pump actuator (25) is coupled to the drive groove (913), when the pump actuator () rotates, rotational force can be applied to the pump knob (910).

[0305] The bearing (920) can wrap around the outer surface of the shaft (911). The bearing (920) can come into contact with the tube (700) when the shaft (911) rotates. This prevents the shaft (911) from directly rubbing against the tube (700).

[0306]

[0307] Meanwhile, FIGS. 25 to 28 illustrate a diagram for explaining the configuration of a diagnostic device according to an embodiment of the present invention.

[0308] Referring to FIGS. 25 to 28, the diagnostic device (2) is described as follows. The diagnostic device (2) may be a diagnostic device for a biosensor.

[0309] When the biosensor cartridge (1) is coupled to the diagnostic device (2), the valve part (800) and pump part (900) of the biosensor cartridge (1) are driven, and an electrical signal generated by the biosensor (400) is received to diagnose the presence of biomaterial.

[0310] The diagnostic device (2) can detect a change in current in the presence of a small amount of target substance from the biosensor cartridge (1), diagnose a disease accordingly, and deliver the result to the user.

[0311] The diagnostic device (2) may include a function to compensate for the reproducibility and non-uniformity of the sensor, including a preprocessing process for correcting the detection signal from the biosensor cartridge (1) so that minute signal changes can be read.

[0312] The diagnostic device (2) may include a QR reader capable of reading a QR code displayed on a biosensor cartridge (1) and receiving environmental information for authenticating the biosensor cartridge (1) to perform authentication, and a communication module capable of transmitting and receiving signals for authentication with an external cloud server.

[0313] The diagnostic device (2) may have a program algorithm or application installed to diagnose a disease by measuring and analyzing detection signals from the biosensor cartridge (1), and different algorithms can be executed depending on the type of each biosensor cartridge (1).

[0314]

[0315] The diagnostic device (2) may include a diagnostic device housing (21), a driving frame (22), a loading unit (23), a valve actuator (24), a pump actuator (25), and a diagnostic device control unit (26).

[0316] The diagnostic device housing (21) can form the exterior of the diagnostic device (2). The diagnostic device housing (21) can accommodate a drive unit frame (22), a loading unit (23), a valve actuator (24), a pump actuator (25), and a diagnostic device control unit (26) inside.

[0317] The diagnostic device housing (21) may be equipped with an operating unit (21a), a display (21b), and a cartridge insertion port (21c). The operating unit (21a) may be provided so that a user can operate it. For example, the operating unit (21a) may be a dial. Additionally, the display (21b) may display the operating status of the diagnostic device (2) and the diagnostic results. Meanwhile, according to an embodiment, the display (21b) may be a touch screen. In this case, the user can input commands through the display (21b). At this time, the operating unit (21a) and the display (21b) may be positioned on the upper part of the diagnostic device housing (21). Through this, the user can easily operate it.

[0318] A cartridge inlet (21c) is formed in the diagnostic device housing (21), and a biosensor cartridge (1) can be inserted therein. At this time, the width of the cartridge inlet (21c) in the horizontal direction may be greater than the height in the vertical direction. That is, the biosensor cartridge (1) can be inserted by being positioned along the horizontal direction. Through this, the buffer solution or sample solution flowing inside the biosensor cartridge (1) can flow stably.

[0319] Meanwhile, the drive unit frame (22) is provided inside the diagnostic device housing (21) and can support the loading unit (23), valve actuator (24), and pump actuator (25). The drive unit frame (22) can be coupled to and supported by the diagnostic device housing (21).

[0320] The loading section (23) is coupled with a valve actuator (24) and a pump actuator (25) and can move the valve actuator (24) and the pump actuator (25) downward and upward. Specifically, the loading section (23) may include a loading plate (23a) and a loading actuator (23b). The valve actuator (24) and the pump actuator (25) may be coupled to the loading plate (23a). The loading plate (23a) is connected to the loading actuator (23b) by means of a gear or the like, and can be moved upward or downward depending on the operation of the loading actuator (23b).

[0321] Meanwhile, the valve actuator (24) can be coupled with the valve part (800). Specifically, the valve actuator (24) can be coupled with the valve knob (820) to rotate the valve knob (820).

[0322] The valve actuator (24) can be connected to the actuator shaft (24a). For example, the valve actuator (24) includes a valve motor (24d) and is connected to the actuator shaft (24a) through a gear connected to the valve motor (24d), and can rotate the actuator shaft (24a) through the operation of the valve motor (24d).

[0323] The actuator shaft (24a) can be coupled to the knob groove (823) of the valve knob (820). The actuator shaft (24a) can be coupled to the knob groove (823) of the valve knob (820) when the loading plate (23a) is lowered.

[0324] At this time, a key frame (24ab) may be coupled to the actuator shaft (24a). The key frame (24ab) may be positioned along a direction intersecting the longitudinal direction of the actuator shaft (24a). For example, the key frame (24ab) may be formed in a cylindrical shape, positioned along a direction intersecting the longitudinal direction of the actuator shaft (24a), and positioned to penetrate the actuator shaft (24a). With this configuration, when the actuator shaft (24a) descends, the key frame (24ab) may be coupled to the knob groove (823). Then, while the key frame (24ab) is coupled to the knob groove (823), when the actuator shaft (24a) rotates, the valve knob (820) may rotate together in conjunction with it.

[0325] The actuator shaft (24a) is formed in a cylindrical shape and can accommodate a spring inside, and a key frame (24ab) can be placed at the bottom of the spring.

[0326] Accordingly, when the loading plate (23a) descends, if the key frame (24ab) is not received into the knob groove (823), the spring is compressed, and the key frame (24ab) can remain in contact with the top 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), and when the key frame (24ab) is positioned vertically above the knob groove (823), the key frame (24ab) can be fitted into the knob groove (823) by the elastic force of the spring. After that, when the actuator shaft (24a) rotates, the valve knob (820) can rotate together in conjunction with it.

[0327] Meanwhile, the actuator shaft (24a) may be provided with an alignment guide (24b). For example, the alignment guide (24b) may be formed in the shape of a disc, and the actuator shaft (24a) may pass through it. A guide slit (24ba) may be formed in the alignment guide (24b). The guide slit (24ba) may be formed along the radial direction.

[0328] The alignment guide section (24b) can detect the original position of the actuator shaft (24a) by the alignment detection section (24c). At this time, the alignment detection section (24c) can detect the original position of the actuator shaft (24a) by detecting the guide slit (24ba). For example, the alignment detection section (24c) may be a photo interrupter. That is, the alignment detection section (24c) includes a light source and a light receiver, and either the light source or the light receiver may be positioned on the upper side of the alignment guide section (24b), and the other may be positioned on the lower side of the alignment guide section (24b). Therefore, when the guide slit (24ba) is positioned between the light source and the light receiver, it can be detected that the actuator shaft (24a) is positioned in its original position.

[0329] Meanwhile, the pump actuator (25) can be combined with the pump unit (900). For example, the pump actuator (25) includes a pump motor (25d), is connected to an actuator shaft (25a) through a gear connected to the pump motor (25d), and can rotate the actuator shaft (25a) through the operation of the pump motor (25d).

[0330] The pump actuator (25) can be connected to the actuator shaft (25a). The pump actuator (25) is connected to the actuator shaft (25a) through a gear and can rotate the actuator shaft (25a).

[0331] The actuator shaft (25a) can be coupled to the drive groove (913) of the pump knob (910). The actuator shaft (25a) can be coupled to the drive groove (913) of the pump knob (910) when the loading plate (23a) is lowered.

[0332] At this time, a key frame (not shown) may be coupled to the actuator shaft (25a). Additionally, an alignment guide part (25b) may be provided on the actuator shaft (25a). Furthermore, an alignment detection part (25c) may be provided on the pump actuator (25).

[0333] Meanwhile, to avoid repeated explanations, the key frame, alignment guide (25b), and alignment detection (25c) of the pump actuator (25) have the same structure and effect as the key frame (24ab), alignment guide (24b), and alignment detection (24c) of the pump actuator (24), so they can be utilized.

[0334]

[0335] Referring to FIG. 34, the control relationship between the biosensor cartridge (1) and the diagnostic device (2) of the present invention is explained as follows.

[0336] The diagnostic device control unit (26) can be placed inside the diagnostic device housing (21).

[0337] The diagnostic device control unit (26) may be composed of a printed circuit board and components mounted on the printed circuit board.

[0338] Although not shown, the diagnostic device control unit (26) may be equipped with a memory and a timer. Through this, preset data can be stored and control commands can be executed for a set period of time.

[0339] The diagnostic device control unit (26) can control the loading actuator (23b). The diagnostic device control unit (26) can raise or lower the loading unit (23) by controlling the loading actuator (23b).

[0340] Meanwhile, the diagnostic device control unit (26) can control the valve actuator (24). Additionally, the diagnostic device control unit (26) can control 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) through an encoder, and thereby control the rotation angle of the actuator shaft (24a). Through this, the diagnostic device control unit (26) can rotate the connection channel (833) of the valve unit (800) to an accurate position and accurately switch the connected channel (600).

[0341] Additionally, the diagnostic device control unit (26) is signal-connected to the alignment detection unit (24c) to detect whether the actuator shaft (24a) is in its original position. Accordingly, the diagnostic device control unit (26) can control the valve motor (24d) to rotate the actuator shaft (24a) back to its original position.

[0342] Meanwhile, 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) through an encoder, and thereby control the rotational speed of the actuator shaft (25a). Through this, the diagnostic device control unit (26) can control the rotational speed of the pump unit (900) to control the flow rate of the buffer solution and sample solution flowing through the channel (600) and tube (700).

[0343] Additionally, the diagnostic device control unit (26) is signal-connected to the alignment detection unit (25c) to detect whether the actuator shaft (25a) is in its original position. Accordingly, the diagnostic device control unit (26) can control the pump motor (25d) to rotate the actuator shaft (25a) back to its original position.

[0344] Additionally, the diagnostic device control unit (26) can be signal-connected to the operation unit (21a) and the display (21b). When a user's 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 transmit information to the display (21b). Through this, the current status of the diagnostic device (2) can be displayed.

[0345] Additionally, the diagnostic device control unit (26) can be electrically connected to the biosensor cartridge (1). Specifically, the diagnostic device control unit (26) can be electrically connected to the printed circuit board (500) provided in the biosensor cartridge (1). The diagnostic device control unit (26) can detect the presence of biomaterial by receiving an electrical signal received from the printed circuit board (500). Additionally, it can diagnose the type of biomaterial based on pre-stored data.

[0346] Although not shown, the diagnostic device control unit (26) may be equipped with a communication unit. The diagnostic device control unit (26) may communicate with a terminal (not shown) through the communication unit. The communication unit may support wireless communication with other devices located outside the diagnostic device (2), including the terminal (not shown). A short-range communication module or a long-range communication module may be provided as a wireless communication module to support wireless communication. Through this, the status of the diagnostic device (2) or the diagnostic results regarding the biomaterial can be transmitted to the user, and control commands can be received remotely from the user.

[0347]

[0348] Meanwhile, FIGS. 23 to 35 illustrate a process for diagnosing a sample solution introduced into a biosensor cartridge using a diagnostic device according to an embodiment of the present invention.

[0349] Referring to FIGS. 23 to 35, the process of diagnosing a sample solution introduced into a biosensor cartridge using a diagnostic device according to one embodiment of the present invention is described as follows.

[0350] The biosensor cartridge (1) may have a biosensor (400) and a printed circuit board (500) combined therein. However, if there is an error in the biosensor (400) and the printed circuit board (500), the user may replace them.

[0351] The user can inject the buffer solution into the biosensor cartridge (1). Specifically, the user can inject it into the buffer solution injection hole (111). In this case, the present invention may use a buffer blister (3) to inject the buffer solution into the buffer solution injection hole (111).

[0352] For example, the buffer blister (3) may be formed with a circular dome shape at the top and a flat shape at the bottom. In this case, the top of the buffer blister (3) may be formed of a deformable material, and the bottom surface of the buffer blister (3) may be formed of a tearable material.

[0353] The buffer blister (3) can be received in the blister receiving groove (111a). At this time, the buffer blister (3) may be provided in a fixed state in the blister receiving groove (111a), and the buffer blister (3) may also be detachably coupled to the blister receiving groove (111a).

[0354] Accordingly, the user can press the buffer blister (3) downward using a finger or the like while the buffer blister (3) is placed inside the blister receiving groove (111a). In this case, the upper part of the dome-shaped buffer blister (3) is deformed downward, and the internal pressure of the buffer blister (3) can be increased. At the same time, the blister punch (111d) protruding from the blister receiving groove (111a) can pierce and burst the lower surface of the buffer blister (3). Accordingly, the buffer solution stored inside the buffer blister (3) can flow downward due to gravity and enter the buffer solution injection hole (111) (see FIG. 23).

[0355] And, the buffer solution that has passed through the buffer solution inlet hole (111) can be contained in the buffer solution tank (310). And, it can flow into the buffer solution inlet port (315) along the inclined surface (311). And, some of the buffer solution contained in the buffer solution tank (310) can flow along the buffer solution channel (610). However, unless the pump unit (900) is operating, it may not flow into the sensing channel (630).

[0356] Meanwhile, the user can inject the sample solution into the sample solution injection hole (112). At this time, the user can inject the sample solution into the sample solution injection hole (112) using a sample injection tool (4) including a dropper.

[0357] Meanwhile, it is possible to inject the buffer solution and the sample solution simultaneously, to inject the sample solution first and then the buffer solution, or to inject the buffer solution first and then the sample solution.

[0358] The sample solution that has passed through the sample solution inlet hole (112) can be received in the sample solution tank (320). And, some of the sample solution received in the sample solution tank (320) can flow along the sample solution channel (620). However, unless the pump unit (900) is operated, it may not flow into the sensing channel (630).

[0359] As a result, after the buffer solution and sample solution are introduced, the user can insert the biosensor cartridge (1) into the diagnostic device (2).

[0360] Meanwhile, before the biosensor cartridge (1) is inserted into the diagnostic device (2), the diagnostic device control unit (26) can check whether the actuator shafts (24a, 25a) of the valve actuator (24) and the pump actuator (25) are aligned to the initial position (original position) (S10). That is, the diagnostic device control unit (26) can operate the alignment detection unit (24c, 25c) and can detect whether the guide slit (24ba, 25ba) is in the initial position through the alignment detection unit (24c, 25c).

[0361] When a user inserts a biosensor cartridge (1) into a cartridge inlet (21c) formed in a diagnostic device (2), a valve knob (820) may be positioned vertically below the actuator shaft (24a) of a valve actuator (24), and a pump knob (910) may be positioned vertically below the actuator shaft (25a) of a pump actuator (25).

[0362] Additionally, although not illustrated, when the biosensor cartridge (1) is inserted into the diagnostic device (2), the printed circuit board (500) can be electrically connected to a terminal embedded in the diagnostic device (2). Power can be supplied to the printed circuit board (500) and the biosensor (400). The diagnostic device control unit (26) can detect an electrical signal received through the printed circuit board (500). Therefore, when power is supplied from the diagnostic device (2) to the printed circuit board (500), the diagnostic device control unit (26) can detect that the biosensor cartridge (1) is coupled (S20).

[0363] Meanwhile, although not shown, the diagnostic device (2) may further include a combined detection unit composed of a contact sensor such as a micro switch or a non-contact sensor such as an IR sensor, and the diagnostic device control unit (26) may detect that the biosensor cartridge (1) is combined through the combined detection unit.

[0364] When the diagnostic device control unit (26) detects that the biosensor cartridge (1) has been inserted into the diagnostic device (2), the diagnostic device control unit (26) can operate the loading actuator (23b). The diagnostic device control unit (26) can operate the loading actuator (23b) to lower the loading plate (23a) (S30). Thus, the valve actuator (24) and the pump actuator (25) can be moved downward. Through this, the actuator shaft (24a) of the valve actuator (24) can be coupled with the valve knob (820), and the actuator shaft (25a) of the pump actuator (25) can be coupled with the pump knob (910).

[0365] Meanwhile, the diagnostic device control unit (26) can operate the valve actuator (24) and / or pump actuator (25) to rotate the actuator shaft (24a, 25a) once after the operation of the loading actuator (23b) is terminated (S60). That is, the actuator shaft (24a) of the valve actuator (24) and / or the actuator shaft (25a) of the pump actuator (25) can be rotated 360 degrees. Through this, even if the key frame (24ab) provided on the actuator shaft (24a, 25a) is not initially received in the knob groove (823) or the driving groove (913), it can be coupled with the knob groove (823) or the driving groove (913) during the process of one rotation of the actuator shaft (24a, 25a) (see FIG. 30). Accordingly, in the subsequent process, the valve knob (820) and / or pump knob (910) can be aligned to their original positions, and the valve section (800) and the pump section (900) can be precisely controlled through the control of the valve actuator (24) and / or pump actuator (25).

[0366]

[0367] Afterwards, the diagnostic device control unit (26) can detect biomaterials by receiving the electrical signal detected by the biosensor (400) while driving the valve actuator (24) and the pump actuator (25).

[0368] First, the diagnostic device control unit (26) can perform a prefill step (S50).

[0369] In the prefill step (S50), the diagnostic device control unit (26) can operate the valve actuator (24) to connect the prefill port (645) 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 positioned at a preset first position (see FIG. 31a).

[0370] And, the diagnostic device control unit (26) can operate the pump actuator (25) while the prefill 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. Accordingly, the sample solution contained in the sample solution tank (320) can flow into the prefill channel (640) after passing through the sample solution channel (620) (see FIG. 31b). Through this, the sample solution can be made to fill the sample solution channel (620) completely, and bubbles can be removed through the prefill channel (640).

[0371] Afterwards, the diagnostic device control unit (26) can perform a buffer solution circulation step (S60).

[0372] In the buffer solution circulation step (S60), the diagnostic device control unit (26) can operate the valve actuator (24) to connect the buffer solution port (615) and the sensing port (635).

[0373] To this end, the diagnostic device control unit (26) can control the valve actuator (24) so ​​that the connection channel (833) is positioned at a preset second position (see FIG. 32a).

[0374] And, the diagnostic device control unit (26) can operate the pump actuator (25) while the buffer solution port (615) 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. Accordingly, the buffer solution contained in the buffer solution tank (310) can flow through the sensing channel (630) after passing through the buffer solution channel (610) (see FIG. 32b).

[0375] However, according to the embodiment, the pump actuator (25) may be stopped from operating while the valve actuator (24) is operating. This is to prevent the pump unit (900) from operating while the valve unit (800) is converting the channel (600) to which it connects, thereby preventing air bubbles from entering the sensing channel (630) or the buffer solution or sample solution from leaking.

[0376] At this time, the diagnostic device control unit (26) can detect an electrical signal received through the printed circuit board (500). Through this, the diagnostic device control unit (26) can determine whether there is an error in the printed circuit board (500) and / or the biosensor (400).

[0377] Afterwards, the diagnostic device control unit (26) can perform the sample solution circulation step (S70).

[0378] In the sample solution circulation step (S70), the diagnostic device control unit (26) can operate 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 positioned at a preset third position (see FIG. 33a).

[0379] And, the diagnostic device control unit (26) can operate the pump actuator (25) while the sample solution port (625) 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. Accordingly, the sample solution contained in the sample solution tank (320) can flow through the sensing channel (630) after passing through the sample solution channel (620) (see FIG. 33b).

[0380] At this time, the diagnostic device control unit (26) can detect an electrical signal received through the printed circuit board (500) (S80). Then, the diagnostic device control unit (26) can determine whether there is a biomaterial by comparing the electrical signal value in the buffer solution circulation step (S60) with the electrical signal value in the sample solution circulation step (S70).

[0381] Afterwards, the diagnostic device control unit (26) can indicate whether there is a biomaterial through the display (21b).

[0382] 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 positioned at a preset first position.

[0383] Additionally, the diagnostic device control unit (26) can operate the pump actuator (25) while the buffer solution port (615) 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. Accordingly, the buffer solution contained in the buffer solution tank (320) can flow through the buffer solution channel (610), the sensing channel (630), and the tube (700) to the waste solution tank (330). In this process, the buffer solution can clean the channel (600) and the tube (700).

[0384] Through this, the flow path formed in the biosensor cartridge (1) can be automatically cleaned, and there is an advantage in that some parts of the biosensor cartridge (1) can be reused.

[0385] Afterward, when the operation of the pump actuator (25) is terminated, the diagnostic device control unit (26) can operate the loading actuator (23b). The diagnostic device control unit (26) can operate the loading actuator (23b) to raise the loading plate (23a). Thus, the valve actuator (24) and the pump actuator (25) can be moved upward. Through this, the actuator shafts (24a, 25a) can be separated from the valve knob (820) and the pump knob (910).

[0386] Afterwards, the diagnostic device control unit (26) can notify the user through the display (21b), etc., that the diagnosis for the biosensor cartridge (1) has been completed.

[0387] Afterwards, the user can pull out and detach the biosensor cartridge (1) that was inserted into the diagnostic device (2).

[0388]

[0389] Although the present invention has been described in detail through specific embodiments, this is for the purpose of specifically explaining the invention and is not limited thereto. It is evident that modifications or improvements can be made by those skilled in the art within the technical scope of the present invention.

[0390] All simple variations or modifications of the present invention fall within the scope of the present invention, and the specific scope of protection of the present invention will be clarified by the appended claims.

Claims

1. A biosensor cartridge comprising a frame disposed within a housing, a channel formed in the frame providing a path for a buffer solution or sample solution to flow through, a biosensor coupled to the frame to detect a biomaterial, and a pump unit that generates a flow force for the buffer solution or sample solution flowing through the channel; and A diagnostic device comprising: a diagnostic device housing having a cartridge input port into which the biosensor cartridge is inserted; and a pump actuator disposed within the diagnostic device housing and coupled to the pump unit to rotate the pump unit; A biosensor system including 2. In Paragraph 1, A biosensor system characterized in that when the biosensor cartridge is inserted into the diagnostic device, the pump actuator descends and is coupled to the pump unit.

3. In Paragraph 1, The above biosensor cartridge is, A valve unit that selectively opens and closes a buffer solution channel into which the buffer solution is introduced or a sample solution channel into which the sample solution is introduced, thereby introducing the buffer solution or the sample solution toward the biosensor; A biosensor system further comprising 4. In Paragraph 3, The above diagnostic device is, A valve actuator coupled to the valve knob of the above valve part and rotating the valve knob; A biosensor system further comprising 5. In Paragraph 4, A biosensor system characterized in that when the biosensor cartridge is inserted into the diagnostic device, the valve actuator descends and engages with the valve part.

6. In Paragraph 1, The above pump actuator is, An actuator shaft coupled to the pump unit and rotating the pump unit; An alignment guide portion formed with a larger diameter than the actuator shaft, having a guide slit formed therein, and rotating integrally with the actuator shaft; and An alignment detection unit that detects the position of the guide slit when the alignment guide unit rotates; Includes, The above pump actuator is, A biosensor system characterized by rotating the actuator shaft to position the alignment detection part and the guide slit on a vertical line before the biosensor cartridge is inserted into the diagnostic device.

7. A biosensor cartridge comprising a frame disposed within a housing, a channel formed in the frame providing a path for a buffer solution or sample solution to flow through, a biosensor coupled to the frame for detecting biomaterials, and a valve portion for selectively opening and closing the channel to introduce the buffer solution or sample solution toward the biosensor; and A diagnostic device comprising: a diagnostic device housing having a cartridge input port into which the biosensor cartridge is inserted; and a valve actuator disposed within the diagnostic device housing and coupled to the valve portion to rotate the valve portion; Includes, The above channel is, A buffer solution channel into which the above buffer solution flows; A sample solution channel into which the above sample solution flows; and A sensing channel that guides the buffer solution or the sample solution to the biosensor; Includes, The above valve part is, A biosensor system characterized by connecting the buffer solution channel and the sensing channel, and then connecting the sample solution channel and the sensing channel.

8. In Paragraph 7, The above channel is, A prefill channel connected to the sample solution channel and through which the sample solution flows; A biosensor system including additional 9. In Paragraph 8, The above valve part is, A biosensor system characterized by connecting the above-mentioned prefill channel and the above-mentioned normal sensing channel, and then connecting the above-mentioned buffer solution channel and the above-mentioned sensing channel.

10. In Paragraph 7, The above biosensor cartridge is, A pump unit that generates a flow force in the buffer solution or sample solution flowing through the channel; A biosensor system further comprising 11. In Paragraph 10, The above diagnostic device is, A pump actuator disposed within the housing of the diagnostic device and coupled to the pump unit to rotate the pump unit; Includes more, The above pump actuator is, A biosensor system characterized by operating when the rotation of the above valve part stops.

12. In Paragraph 7, A biosensor system characterized in that when the biosensor cartridge is inserted into the diagnostic device, the valve actuator descends and engages with the valve part.

13. In Paragraph 12, The above valve actuator is, An actuator shaft coupled to the above valve part and rotating the above valve part; Includes, A biosensor system characterized by the actuator shaft rotating one full turn after the valve actuator moves downward.

14. A method for controlling a diagnostic device that detects a biomaterial contained in a sample solution introduced into the biosensor cartridge, wherein the biosensor cartridge including the biosensor is combined, A shaft alignment step for aligning the actuator shaft of a valve actuator that rotates a valve part provided in the biosensor cartridge and the actuator shaft of a pump actuator that rotates 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 diagnostic step of detecting the biomaterial by rotating the valve part and the pump part; A control method for a biosensor system including 15. In Paragraph 14, In the shaft alignment step above, A control method for a biosensor system characterized by detecting a guide slit that rotates together with the actuator shaft through an alignment detection unit while rotating the actuator shaft.

16. In Paragraph 14, In the above loading step, A control method for a biosensor system characterized by the loading plate, to which the valve actuator and the pump actuator are combined, moving downward.

17. In Paragraph 14, The above diagnostic step is, A prefill step of operating the valve actuator to rotate the connection channel formed in the valve part to a first position; After the above prefill step, a buffer solution circulation step of operating the valve actuator to rotate the connection channel to a second position different from the first position; and After the buffer solution circulation step above, a sample solution circulation step in which the valve actuator is operated to rotate the connection channel to a third position different from the first position and the second position; A control method for a biosensor system including

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