Biosensor cartridge and biosensor device including same

By designing a biosensor box composed of multi-electrodes and partitions, using spatial separation technology and electrochemiluminescent signals, the problem that existing in vitro diagnostic equipment cannot meet the high performance and miniaturization needs under the new trend is solved, and high sensitivity and rapid in vitro diagnosis are achieved.

CN119790295APending Publication Date: 2025-04-08ELIBUS DIAGNOSTICS +1
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Patent Information

Application Number
CN202380062971.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-07-29
Filing Date
2023-07-27
Publication Date
2025-04-08

AI Technical Summary

Technical Problem

Existing in vitro diagnostic equipment cannot meet the needs of high performance, decentralization, decentralization and miniaturization/field under the new trend, especially in early disease diagnosis and prevention and treatment.

Method used

A biosensor box is designed, including multiple electrodes and divisions, forming a signal chamber and a multiple reaction chamber through spatial separation, using electrochemiluminescent signals to achieve high sensitivity in vitro diagnosis, and achieving rapid diagnosis through miniaturized devices.

Benefits of technology

It realizes high sensitivity in vitro diagnosis, has a rapid diagnosis speed and a compact structure, and is suitable for on-site popularization. It can diagnose multiple samples at the same time, significantly improving the diagnosis speed.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention discloses a biosensor cartridge. A biosensor cartridge according to one embodiment of the present invention detects a biological substance and generates an electrochemiluminescence signal, the biosensor cartridge comprising: an electrode unit including a plurality of electrodes; and a division unit disposed on the electrode unit so as to divide the entire space formed on the electrode unit into a signal chamber and N reaction chambers surrounding the signal chamber, the electrode unit including: a first electrode at least partially disposed in the reaction chambers; a second electrode disposed in the signal chamber; and N connection electrodes arranged so as to link the chemical reaction in the reaction chamber with the electrochemiluminescence signal generated in the signal chamber.
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Description

Technical Field

[0001] The present invention relates to a biosensor cartridge, and more particularly, to a biosensor cartridge for detecting biological substances to generate electrochemiluminescent signals and a biosensor device including the same. Background Art

[0002] In vitro diagnostic technology is generally divided into molecular diagnostic technology for quantitative / qualitative analysis of specific genes, immunodiagnostic technology for analyzing specific antigens / proteins, clinical chemical analysis technology for analyzing the concentration of biological single molecules, and analysis technology for extracellular vesicles (EV) generated during cell metabolism. This in vitro diagnostic technology is widely used in various fields such as infectious diseases, diabetes, oncology, cardiology, autoimmune diseases, and new drug development.

[0003] On the other hand, regarding in vitro diagnostic technology, recently, as the demand for early diagnosis and preventive treatment and health monitoring for diagnosing diseases at an earlier stage increases, there is a trend of shifting from diagnostic examinations centered on large hospitals to decentralized / on-site diagnostic examinations centered on patients.

[0004] In order to respond to this new trend, it is necessary to develop in vitro diagnostic equipment that can achieve high performance, decentralization, and miniaturization / on-site effects.

[0005] However, current in vitro diagnostic equipment is polarized into two types based on the form of examination: high-performance / large / high-priced diagnostic equipment for central examination rooms and low-performance / small / low-priced field diagnostic equipment. Therefore, there is currently no alternative technical solution that can adapt to the new trend. Summary of the invention

[0006] The present invention is used to solve the above-mentioned problems. The purpose of the present invention is to provide the following biosensor box and the biosensor device including the same, which have high-sensitivity in vitro diagnostic performance and have a rapid diagnostic speed and a compact structure so as to facilitate on-site popularization.

[0007] The problems of the present invention are not limited to the problems mentioned above, and ordinary technicians in the technical field to which the present invention belongs can clearly understand other problems not mentioned from the following description.

[0008] According to one embodiment of the present invention, the present invention provides a biosensor box, which detects biological substances to generate electrochemical luminescence signals, the above-mentioned biosensor box includes: an electrode portion, including a plurality of electrodes; and a dividing portion, arranged on the above-mentioned electrode portion to divide the entire space formed on the above-mentioned electrode portion into a signal chamber and N reaction chambers surrounding the above-mentioned signal chamber, the above-mentioned electrode portion includes: a first electrode, at least a portion of which is arranged in the above-mentioned reaction chamber; a second electrode, which is arranged in the above-mentioned signal chamber; and N connecting electrodes, which are arranged in a manner that the chemical reaction in the above-mentioned reaction chamber is linked to the above-mentioned electrochemical luminescence signal occurring in the above-mentioned signal chamber.

[0009] In this case, the connection electrode may include a detection portion disposed in the reaction chamber and a light emitting portion disposed in the signal chamber to be formed as one body.

[0010] In this case, the detection portion of the connecting electrode may surround at least a portion of the first electrode while being spaced apart from the first electrode by a predetermined distance, and the light emitting portion of the connecting electrode may be arranged toward the second electrode with an end portion having a tapered shape.

[0011] In this case, the connecting electrode may be in a Y shape as a whole.

[0012] In this case, the electrode portion may be formed in a circular shape, and the outer portion of the partition portion may be formed in a circular shape so as to correspond to the shape of the electrode portion.

[0013] In this case, the dividing portion may include: an outer wall, which is arranged at the outermost side of the dividing portion and forms a side portion of the N reaction chambers; an inner wall, which is arranged on the inner side of the outer wall and divides the signal chamber; and a partition extending from the inner circumferential surface of the outer wall to the outer circumferential surface of the inner wall, and the N partitions are arranged to be spaced apart along the circumferential direction of the inner wall.

[0014] In this case, the outer wall and the inner wall may be formed in a circular shape, and the eight partitions may be arranged at equal intervals to form eight reaction chambers between the inner wall and the outer wall.

[0015] In this case, the second electrode may have an octagonal shape.

[0016] In this case, the inner wall may be arranged so as to cross the N connection electrodes, and an insulator may be arranged at a portion of the N connection electrodes where the inner wall is arranged.

[0017] In this case, the first electrode may include a support portion formed in a single closed curve shape and divided into N parts by the dividing portion.

[0018] In this case, the support portion may be formed in a circular shape centered on the second electrode.

[0019] In this case, the first electrode may further include N reaction portions protruding from the support portion in a direction toward the second electrode, and the N reaction portions are disposed in the N reaction chambers one by one.

[0020] In this case, the reaction portion may be formed in a circular shape, and the one end portion of the connection electrode may surround the reaction portion while being spaced apart from the reaction portion by a predetermined distance.

[0021] In this case, different samples collected from separate entities may be introduced into the N reaction chambers.

[0022] In this case, the same sample collected from the same individual may be introduced into the N reaction chambers, and different detection reagents may be introduced into the same sample in order to detect a plurality of biological substances.

[0023] In this case, the above-mentioned biological substance may refer to a substance used to detect whether it is an infectious disease, a metabolic disease, an immune disease or a cancer, and may be at least one of DNA, RNA, protein, metabolites and extracellular vesicles.

[0024] According to another embodiment of the present invention, the present invention includes: the above-mentioned biosensor box; a main body portion, which is formed with a housing space in a manner of housing the above-mentioned biosensor box; a voltage applying portion, which is arranged on the above-mentioned housing space side of the above-mentioned main body portion and applies voltage to the above-mentioned electrode portion side of the above-mentioned biosensor box; and an image sensor portion, which is used to capture the above-mentioned electrochemical luminescence signal generated from the second chamber of the above-mentioned biosensor box.

[0025] In this case, the biosensor cartridge may be disposable.

[0026] In this case, the partition portion may include at least one insertion protrusion protruding outward at a portion thereof, and the main body portion may be formed with at least one insertion groove for inserting and fixing the insertion protrusion at a position corresponding to the insertion protrusion.

[0027] In this case, the present invention may further include a magnetic force applying member disposed at a position corresponding to the reaction chamber in the accommodation space of the body in such a manner as to apply a magnetic force to the reaction chamber side.

[0028] According to the above structure, the biosensor cartridge according to the embodiment of the present invention forms an optimized reaction condition in each chamber by spatial separation based on the partitioning part, thereby obtaining a highly sensitive detection result.

[0029] Furthermore, the biosensor cartridge of the embodiment of the present invention has multiple reaction chambers so that multiple samples can be diagnosed simultaneously, and multiple light-emitting parts are arranged in a single signal chamber so that the test results can be confirmed immediately, thereby significantly improving the diagnosis speed.

[0030] Furthermore, in the biosensor cartridge according to an embodiment of the present invention, the detection portion and the light emitting portion respectively have connection electrodes with optimized structures, thereby further improving the detection sensitivity.

[0031] Furthermore, the biosensor device according to the embodiment of the present invention can be driven only by an ultra-miniaturized device, and therefore can be easily popularized in medical fields.

[0032] The effects of the present invention are not limited to the above-mentioned effects, but include all effects that can be inferred from the structure of the invention described in the detailed description of the present invention or the scope of claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 FIG. 1 is an exploded perspective view showing a biosensor device according to an embodiment of the present invention.

[0034] Figure 2 FIG. 1 is a diagram briefly showing the structure of a biosensor device according to an embodiment of the present invention.

[0035] Figure 3 The front and rear surfaces of the biosensor cartridge according to one embodiment of the present invention are shown for distinction.

[0036] Figure 4 This is a diagram showing a biosensor cartridge according to an embodiment of the present invention as viewed from above.

[0037] Figure 5 FIG. 1 is a diagram partially showing a portion of an electrode portion of a biosensor cartridge according to an embodiment of the present invention.

[0038] Figure 6 This is a diagram showing another example of the electrode portion of the biosensor cartridge according to one embodiment of the present invention.

[0039] Figure 7 FIG. 1 is a diagram showing connection electrodes of a biosensor cartridge according to an embodiment of the present invention.

[0040] Figure 8 The graphs show how current density was measured by changing the shapes of a plurality of connection electrodes included in a biosensor cartridge according to an embodiment of the present invention.

[0041] Fig. 9 The figure schematically shows the process of pre-treating a sample using magnetic beads.

[0042] Fig.10It is an explanatory diagram for explaining the spatial structure of a biosensor cartridge and the chemical reaction in each chamber according to an embodiment of the present invention.

[0043] Fig.11 It is an explanatory diagram for explaining the spatial structure of a biosensor device according to the prior art.

[0044] Fig.12 A diagram showing the signal chamber before and after voltage is applied to a biosensor cartridge according to an embodiment of the present invention for differentiation. DETAILED DESCRIPTION

[0045] Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings so that a person skilled in the art can easily implement the present invention. The present invention can be embodied in a variety of different forms and is not limited to the embodiments described herein. In order to clearly illustrate the present invention, parts not related to the description are omitted in the accompanying drawings, and the same or similar structural elements are given the same reference numerals throughout the specification.

[0046] The words and terms used in this specification and the scope of protection of the invention should not be interpreted as the usual or dictionary meanings, but should be interpreted as the meanings and concepts that are consistent with the ideas described in the present invention based on the principle that inventors can appropriately define terms and concepts in order to explain their inventions in the best way.

[0047] Figure 1 FIG. 1 is an exploded perspective view showing a biosensor device according to an embodiment of the present invention. Figure 2 FIG. 1 is a diagram briefly showing the structure of a biosensor device according to an embodiment of the present invention. Figure 3 The front and rear surfaces of the biosensor cartridge according to one embodiment of the present invention are shown for distinction. Figure 4 This is a diagram showing a biosensor cartridge according to an embodiment of the present invention as viewed from above. Figure 5 FIG. 1 is a diagram partially showing a portion of an electrode portion of a biosensor cartridge according to an embodiment of the present invention. Figure 6 This is a diagram showing another example of the electrode portion of the biosensor cartridge according to one embodiment of the present invention. Figure 7 FIG. 1 is a diagram showing connection electrodes of a biosensor cartridge according to an embodiment of the present invention. Figure 8 The graphs show how current density was measured by changing the shapes of a plurality of connection electrodes included in a biosensor cartridge according to an embodiment of the present invention.

[0048] For example, the biosensor device 100 according to an embodiment of the present invention is a device that can be used in various fields such as medical fields and research fields where biomaterials need to be detected, and is a device that generates an electrochemical luminescence (ECL) signal based on whether a biomaterial contained in a sample is detected.

[0049] In this case, the biosensor device 100 of one embodiment of the present invention can improve the detection sensitivity by having a biosensor box 10 with multiple reaction chambers 26 and a single signal chamber 27 that are spatially separated from each other, and can quickly diagnose whether multiple samples contain biological substances. The following description will focus on the above-mentioned biosensor box 10.

[0050] The biosensor cartridge 10 according to an embodiment of the present invention is a component for containing a sample as a detection target of a biological substance. Figure 1 As shown, it may include a dividing portion 20 and an electrode portion 30 .

[0051] First, the partitioning portion 20 is a member for partitioning the entire space G formed on the upper portion of the electrode portion 30 described later into a plurality of spaces 26 and 27 .

[0052] More specifically, the partition part 20 may be divided into a signal chamber 27 configuring the entire space G inside and a reaction chamber 26 configured outside.

[0053] In this case, if Figure 4 As shown, the signal chamber 27 is a space arranged in the center of the entire space G, and may exist alone. In this case, a light-emitting portion 37 connected to an electrode 35 described later may be arranged in the signal chamber 27, so that an electrochemical luminescence signal can be observed, which will be described in detail in the corresponding part.

[0054] Next, unlike the signal chamber 27, there may be a plurality of reaction chambers 26. In this case, the plurality of reaction chambers 26 may be arranged so as to surround the signal chamber 27 at the center. For example, as shown in the figure, there may be eight reaction chambers 26, but the number of reaction chambers 26 is not limited to the example shown. That is, when there are two or more reaction chambers 26, there may be a plurality (for example, 24).

[0055] Moreover, although the figure shows that the electrode part 30 is formed in a circle, thereby the entire space G is divided into a circular signal chamber 27 and a reaction chamber 26 in the shape of an unfolded cone, in addition to this, the electrode part 30 can have a variety of shapes such as a positive direction and a rectangle, and is not limited to the shapes of the signal chamber 27 and the reaction chamber 26 or the above-mentioned examples.

[0056] On the other hand, the reaction chamber 26 can contain a sample, and when a voltage is applied to the electrode unit 30, a chemical reaction can be generated in the reaction chamber 26 depending on whether the sample contains biological substances. For the convenience of explanation, this will be comprehensively described in the following part.

[0057] In one embodiment of the present invention, Figure 4As shown, the partition 20 may include an outer wall 21 , an inner wall 22 and a partition 23 .

[0058] First, the outer wall 21 is a portion disposed at the outermost side of the partitioning portion 20 to form a plurality of reaction chambers 26 . As an example, as shown in the figure, the outer wall 21 may be formed into a circular shape having a radius corresponding to the electrode portion 30 .

[0059] Furthermore, the inner wall 22 is a portion disposed inside the partition portion 20 so as to partition the signal chamber 27 , and may be formed in a circular shape having a smaller radius than the outer wall 21 , for example.

[0060] Next, the partition 23 may extend from the inner circumference of the outer wall 21 to the outer circumference of the inner wall 22 in a manner of dividing the space between the outer wall 21 and the inner wall 22. In this case, unlike the outer wall 21 and the inner wall 22, a plurality of partitions 23 may be provided, and preferably, they may be spaced apart at equal intervals in a manner of forming signal chambers 27 of the same size.

[0061] As a specific example, as shown in the figure, in correspondence with the circular electrode portion 30, when the outer wall 21 and the inner wall 22 are also formed in a circular shape, eight partitions 23 can be arranged at equal intervals to form eight reaction chambers 26 having the same volume. As described above, when the outer wall 21 and the inner wall 22 are both formed in a circular shape, the plurality of reaction chambers 26 can have the same volume and shape, so that the reaction chambers 26 can be uniformly formed.

[0062] However, in the above description, the electrode portion 30 and the partition portion 20 are both formed in a circular shape. However, the shapes of the electrode portion 30 and the partition portion 20 are not limited thereto, and may be formed in various shapes as described above.

[0063] In one embodiment of the present invention, for example, the partition part 20 can be bonded and fixed to the electrode part 30 using an adhesive or the like as a medium. Thus, the airtightness between the partition part 20 and the electrode part 30 is ensured to prevent the fluid (sample or reagent) contained in the reaction chamber 26 or the signal chamber 27 from moving to the other chamber side through the fine gap formed at the bottom of the partition part 20.

[0064] In one embodiment of the present invention, the electrode part 30 is a component disposed at the lower side of the partition part 20 to form the signal chamber 27 and the reaction chamber 26 together with the partition part 20. In this case, the electrode part 30 may include a plurality of conductive electrodes 31, 34, and 35, thereby applying a voltage for guiding an electrochemical luminescence signal.

[0065] Specifically, the electrode part 30 may include a plate 39 and a plurality of electrodes 31 , 34 , 35 .

[0066] First, the electrode 39 may be a known printed circuit board (PCB). In this case, the board 39 may be formed in a plate shape having a prescribed thickness, for example, as shown in the figure, may be formed in a circular shape.

[0067] In this case, if Figure 3 As shown in part (a) of FIG. 3 , a first electrode 31, a second electrode 34, and a connecting electrode 35 may be disposed on one surface of a plate 39. In this case, the first electrode 31, the second electrode 34, and the connecting electrode 35 are known electrodes formed of a conductive material in a conductive manner, for example, disposed in a patterned form on the plate 39 by an electroless plating process.

[0068] In one embodiment of the present invention, the first electrode 31 is an electrode at least partially disposed in the reaction chamber 26 , and can function as a medium for generating electrical potential energy in the reaction chamber 26 by chemically reacting in the reaction chamber 26 .

[0069] As a specific example, Figure 4 As shown, the first electrode 31 may include: a support portion 32 extending along the outer side of the plate 39; and a reaction portion 33 protruding from the support portion 32 in a direction toward a second electrode 34 described later.

[0070] In this case, as shown in the figure, the support portion 32 may be formed in a shape corresponding to the overall shape of the electrode portion 30 , and may be formed in a single closed curve shape such as a circle or a square.

[0071] As described above, the support portion 32 of a single form may be divided into a plurality of portions corresponding to the plurality of reaction chambers 26 by the dividing portion 20. In this case, in the support portion 32, each portion divided by the dividing portion 20 may be disposed in an individual reaction chamber 26.

[0072] When a voltage is applied by the voltage applying unit 50 , the supporting portion 32 can realize a chemical reaction involving a sample, and the plurality of reaction portions 33 can be electrically connected to each other so as to form an equipotential.

[0073] Next, when a voltage is applied to the first electrode 31, the reaction portion 33 is a portion that expands the area of ​​the first electrode 31 in order to induce a more active chemical reaction, and is connected to a portion of the support portion 32, as an example. Figure 5 In this case, the number of reaction parts 33 corresponds to the number of reaction chambers 26 , and one reaction part 33 is arranged in each reaction chamber 26 .

[0074] Just, if Figure 3 and Figure 4As shown, the first electrode 31 including the supporting portion 32 and the reaction portion 33 is only an example. Figure 6 As shown, the first electrode 31 may be formed of only the support portion 32 without the reaction portion 33. In this case, the chemical reaction can be sufficiently performed on the support portion 32.

[0075] In one embodiment of the present invention, a single number of second electrodes 34 may be disposed inside the signal chamber 27. In this case, the second electrode 34 may be applied with a voltage by the voltage applying unit 50 together with the first electrode 31. In this case, a lower potential than the first electrode 31 may be formed at the second electrode 34, thereby forming a predetermined potential difference such as 0.4V between the first electrode 31 and the second electrode 34.

[0076] In this case, if Figure 5 As shown, the second electrode 34 may be formed into a regular polygon. For example, when the entire reaction chamber 26 is divided into eight by the dividing portion 20, the second electrode 34 may have an octagonal shape, thereby not applying a bias voltage to any chamber, thereby maintaining uniformity.

[0077] Refer again Figures 3 to 5 , a connection electrode 35 for electrically connecting the reaction chamber 26 and the signal chamber 27 may be disposed between the first electrode 31 and the second electrode 34. To this end, as shown in the figure, the connection electrode 35 may form an integrated structure as a whole without being physically separated, with a portion 36 disposed in the reaction chamber 26 and another portion 37 disposed in the signal chamber 27. That is, the connection electrode 35 may pass through both the reaction chamber 26 and the signal chamber 27, in which case the inner wall 22 of the partition 20 may be disposed in a manner of crossing the connection electrode 35.

[0078] Through the connection electrode 35, the reaction chamber 26 and the signal chamber 27 can be separated by the partition 20 in a manner that does not allow fluid flow in space and electrically connected to each other. The electrical connection may mean that the electrical action of one of the signal chamber 27 and the reaction chamber 26 affects the electrical action of the other chamber.

[0079] In one embodiment of the present invention, the connection electrode 35 may include a detection portion 36 disposed in the reaction chamber 26 together with the first electrode 31 and a light emitting portion 37 disposed in the signal chamber 27 together with the second electrode 34. In this regard, when a voltage is applied to the first electrode 31 and the second electrode 34, a chemical reaction is formed in the detection portion 36, thereby forming an electrochemical luminescence reaction in the light emitting portion 37, which will be described later.

[0080] In this case, the connection electrode 35 may be disposed on a plurality of plates 39 in a manner corresponding to the number of reaction chambers 26. Also, as shown in the figure, both ends of the connection electrode 35 may be disposed at a predetermined interval from the first electrode 31 and the second electrode 34 so that charges cannot be directly transferred.

[0081] Reference Figure 4 When a plurality of connection electrodes 35 are disposed on the board 39 , the detection portion 36 of each connection electrode 35 can be respectively disposed in one of the plurality of reaction chambers 26 . On the contrary, the light emitting portion 37 can be disposed in the signal chamber 27 .

[0082] On the other hand, as an illustrative example of the shape of the connection electrode 35, refer to Figure 7 , the detection portion 36 of the connection electrode 35 can be arranged at a predetermined interval from the reaction portion 33 of the first electrode 31, and is formed in a manner of surrounding the reaction portion 33. As described above, in the biosensor cartridge 10 of one embodiment of the present invention, the detection portion 36 of the connection electrode 35 is formed in a manner of surrounding the reaction portion 33 of the first electrode 31, thereby increasing the electrode area where the charges between the detection portion 36 and the reaction portion 33 of the first electrode 31 can be moved, and the movement of the charges in the connection electrode 35 guided by the chemical reaction in the reaction portion 33 of the first electrode 31 can be further immediately guided. As a result, the chemical reaction of the reaction chamber 26 and the electrochemical luminescence reaction of the signal chamber 27 can be linked more quickly and accurately.

[0083] Refer again Figure 7 The light emitting portion 37 of the connection electrode 35 may have various shapes. For example, as shown in the figure, it may be formed into a pointed tip with a tapered end, or formed into a circular shape similar to the reaction portion 33 of the first electrode 31. It may have various shapes according to the intensity or voltage of the electrochemical luminescence signal required, or the sensitivity of the image sensor unit 70 described later.

[0084] However, in the electrode portion 30 and the dividing portion 20, Figure 4 In the case where the second electrode 34 has an octagonal shape (particularly, the case where the second electrode 34 has an octagonal shape), the inventors of the present invention have observed that the most active electrochemical luminescence reaction is formed in the connecting electrode 35 of the light-emitting portion 37 having a pointed structure with a tapered end (refer to Figure 8 ).

[0085] In summary, the connecting electrode 35 includes a detection portion 36 branched into a two-way structure and a light emitting portion 37 extending in one direction at both ends, so that the whole may be in a Y shape. As a result, the biosensor cartridge 10 of one embodiment of the present invention can maximize the mutual connection between the reaction chamber 26 and the signal chamber 27 through the detection portion 36 and optimize the electrochemical luminescence reaction in the light emitting portion 37.

[0086] In one embodiment of the present invention, referring to Figure 4 In the connection electrode 35, an insulator 38 may be arranged at the portion of the inner wall 22 where the partition 20 is arranged (between the detection portion 36 and the light emitting portion 37) to prevent conduction. As described above, by arranging the insulator 38 at the lower portion of the inner wall 22, the direct electrical connection between the reaction chamber and the signal chamber 27 is disconnected, and the electrical connection is achieved only through the connection electrode 35, thereby further improving the reliability of detection.

[0087] Fig. 9 The figure schematically shows the process of pre-treating a sample using magnetic beads. Fig.10 It is an explanatory diagram for explaining the spatial structure of a biosensor cartridge and the chemical reaction in each chamber according to an embodiment of the present invention. Fig.11 It is an explanatory diagram for explaining the spatial structure of a biosensor device according to the prior art. Fig.12 A diagram showing the signal chamber before and after voltage is applied to a biosensor cartridge according to an embodiment of the present invention for differentiation.

[0088] Hereinafter, the chemical reaction and the electrochemical luminescence reaction in the reaction chamber 26 and the signal chamber 27 of the biosensor cartridge 10 will be described in detail with reference to the drawings.

[0089] First, before the sample is introduced into the reaction chamber 26 of the biosensor cartridge 10, the sample may be subjected to a pretreatment process. Fig. 9 As shown, after the target contained in the sample is captured by immunomagnetic beads, the captured target can be additionally labeled with an oxidase such as glucose oxidase (GOx) through probe antibodies.

[0090] Next, the enzyme-labeled beads and glucose solution are added to the reaction chamber 26, and luminol and hydrogen peroxide are added to the signal chamber 27. 2 O 2 ) and other electrochemiluminescence reagents (ECL reagents).

[0091] Afterwards, when a voltage is applied to the first electrode 31 and the second electrode 34 by the voltage applying unit 50, the following chemical reaction may be formed in the reaction chamber 26 (see Fig.10 ).

[0092] Chemical formula 1

[0093] -First electrode (anode): glucose + O2 →Gluconate + H 2 O 2 (GOx, enzyme reaction), H 2 O 2 →O 2 +2H + +2e -

[0094] -Detection part (cathode) connected to the electrode: 1 / 2O 2 +2H + +2e - →H 2 O

[0095] In this case, in the reaction chamber 26, hydrogen peroxide is generated by the enzyme reaction of the oxidase (GOx) of the enzyme-labeled beads with glucose, and the generated hydrogen peroxide is oxidized in the first electrode 31. Moreover, oxygen and oxygen are reduced in the detection portion 36 connected to the electrode 35. In this case, the number of electrons participating in the reaction is the same as the number of electrons participating in the reaction in the signal chamber 27.

[0096] Through the chemical reaction in the reaction chamber 26 described above, the following chemical reaction can be induced in the signal chamber 27 .

[0097] Chemical formula 2

[0098] - The light-emitting part (anode) connected to the electrode: luminol + H 2 O 2 →O 2 +2H + +N 2 +2e - +3 - AP*, 3 - AP* → 3 - AP+hλ

[0099] - Second electrode (cathode): 1 / 2O 2 +2H + +2e - →H 2 O

[0100] In this case, in the light emitting portion 37 of the signal chamber 27, an electrochemical luminescence reaction is induced in which a chemical substance such as luminol or Ru(bpy) directly emits light based on the movement of electrons caused by the chemical reaction induced in the reaction chamber 26. Therefore, the number of photons generated varies depending on the type and degree of the reaction occurring in the plurality of reaction chambers 26, and the intensity of the light also varies.

[0101] In summary, when a voltage is applied to the first electrode 31 and the second electrode 34, the enzyme-labeled beads will promote a redox reaction in the reaction chamber 26, thereby causing an electrochemical luminescence reaction in the signal chamber 27. In this case, the intensity of the electrochemical reaction in the signal chamber 27 is proportional to the concentration of the target protein. Fig.12 As shown, the light-emitting portion 37 that did not emit light before the voltage was applied to the electrode portion 30 forms an electrochemiluminescence reaction with different intensities according to the concentration of the target protein contained in each reaction chamber 26 after the voltage was applied.

[0102] As described above, the biosensor box 10 of one embodiment of the present invention is spatially separated into a reaction chamber 26 for forming an initial chemical reaction and a signal chamber 27 for forming an electrochemical luminescence reaction by a dividing portion 20. Thus, each chamber 26, 27 can perform each process under optimal reaction conditions without crosstalk, based on which improved detection sensitivity can be achieved.

[0103] More specifically, oxidase (GOx) exhibits effective enzyme activity at a medium pH, whereas electrochemiluminescent reagents (ECL reagents) such as luminol increase their solubility at an alkaline pH above pH 10, and the chemical reactions in the reaction chamber 26 and the signal chamber 27 may mutually change the optimal pH. In view of this problem, the biosensor cartridge 10 of an embodiment of the present invention forms optimal reaction conditions for the two chambers 26 and 27, respectively, thereby achieving a high signal-to-noise ratio.

[0104] However, if Fig.11 As shown, when the signal chamber and the reaction chamber are not spatially separated from each other, it is impossible to form reaction conditions that can optimize both reactions. That is, in this case, such as pH 8.5, only reaction conditions corresponding to the intermediate value of the above two optimal conditions can be formed. Therefore, when based on a single chamber structure, the high level of signal-to-noise ratio of the present invention cannot be expected.

[0105] On the other hand, the above-mentioned pretreatment process or the reagents put into each chamber are only illustrative examples, and the application of the present invention is not limited to the above-mentioned examples. That is, the designer can select the optimal pretreatment process and reagents in various ways according to the target biological substance.

[0106] Various samples can be put into the multiple reaction chambers 26 of the biosensor cartridge 10 according to one embodiment of the present invention. For example, when the biosensor cartridge 10 includes eight reaction chambers 26, eight samples collected from eight different individuals can be put into each chamber. As described above, different samples are put into each chamber, and the light emitting portion 37 that notifies the detection result of the target substance contained in the sample is arranged in a single signal chamber 27.

[0107] Thus, the biosensor cartridge 10 of one embodiment of the present invention has the advantage that multiple individuals can be examined simultaneously, and the results can be simultaneously confirmed by photographing a single signal chamber 27, significantly increasing the detection speed only with a small device.

[0108] Hereinafter, a biosensor device 100 according to an embodiment of the present invention will be described.

[0109] Reference Figure 1 and Figure 2 The biosensor device 100 according to an embodiment of the present invention may include a biosensor cartridge 10 , a body portion 40 , a voltage applying portion 50 and an image sensor portion 70 .

[0110] First, if Figure 1 As shown, the main body 40 is a component for mounting the biosensor cartridge 10, and can stably support the biosensor cartridge 10. To this end, the main body 40 can form a receiving space 41 in which the biosensor cartridge 10 can be inserted. In addition, an insertion groove 42 of a corresponding size can be formed on one side of the receiving space 41 of the main body 40, so that the insertion protrusion 25 formed to protrude from the partition 20 of the biosensor cartridge 10 to the outside direction can be inserted and fixed.

[0111] Next, a voltage applying unit 50 for applying voltage to the electrode unit 30 side of the biosensor cartridge 10 installed in the housing space 41 may be disposed in the housing space 41 of the main body 40. In this case, the voltage applying unit 50 may be electrically connected to the contact electrode 31a formed on the back side of the electrode unit 30 through a known terminal member such as a bare electrode or a spring electrode or a pogo pin.

[0112] On the other hand, in the accommodation space 41, a magnetic force applying member 60 for applying a magnetic force to the magnetic beads in the reaction chamber 26 may be provided at a position corresponding to the reaction chamber 26 of the electrode unit 30. In this case, the magnetic force applying member 60 is arranged adjacent to the first electrode 31, thereby applying an attractive force in a manner that causes the magnetic beads to be located on the first electrode 31 to increase the density of the magnetic beads located on the first electrode 31, thereby inducing a more active chemical reaction.

[0113] On the other hand, Figure 2 As shown, an image sensor unit 70 for photographing the electrochemiluminescence signal generated from the signal chamber 27 may be disposed on the upper side of the biosensor cartridge 10. In this case, the image sensor unit 70 may include a camera, a charge coupled device (CCD), an integrated circuit such as a CMOS, or a known image sensor such as a photomultiplier tube.

[0114] On the other hand, when additional testing is required, the biosensor cartridge 10 can be disposable so that it can be replaced immediately and repeatedly, thereby further significantly saving the time required for testing.

[0115] As described above, the biosensor cartridge 10 according to an embodiment of the present invention obtains highly sensitive detection results by spatial separation based on the partitioning portion 20. In addition, the biosensor cartridge 10 according to an embodiment of the present invention has a plurality of reaction chambers 26 in a manner that allows for simultaneous diagnosis of a plurality of samples, and a plurality of light emitting portions 37 are arranged in a single signal chamber 27 so that the detection results can be confirmed immediately, thereby significantly improving the diagnosis speed. Therefore, compared to the existing high-priced devices, the biosensor device 100 according to an embodiment of the present invention can be driven only by an ultra-miniaturized device, and therefore can be easily popularized in medical fields.

[0116] Therefore, the biosensor device 100 of one embodiment of the present invention requires rapid diagnosis and requires an expensive device, and can be effectively used for early diagnosis of serious diseases including sepsis or novel coronavirus infection (COVID19) that require frequent diagnosis on site.

[0117] The above describes one embodiment of the present invention. The concept of the present invention is not limited to the embodiment disclosed in this specification. Ordinary technicians in the technical field of the present invention can easily propose other embodiments within the same scope of the concept by adding, changing, deleting, and appending structural elements, which also falls within the scope of the concept of the present invention.

[0118] Description of Reference Numerals

[0119] 10: Biosensor cartridge 20: Division unit

[0120] 30: Electrode part 40: Main body part

[0121] 50: voltage applying unit 60: magnetic force applying member

[0122] 70: Image sensor unit 100: Biosensor device

Claims

1. A biosensor cartridge for detecting biological substances to generate electrochemiluminescent signals, characterized in that: include: an electrode portion including a plurality of electrodes; and a dividing portion, arranged on the electrode portion, to divide the entire space formed on the electrode portion into a signal chamber and N reaction chambers surrounding the signal chamber, The electrode unit includes: A first electrode, at least a portion of which is disposed in the reaction chamber; A second electrode is disposed in the signal chamber; and The N connecting electrodes are arranged in such a way that the chemical reaction in the reaction chamber is linked to the electrochemical luminescence signal generated in the signal chamber.

2. The biosensor cartridge according to claim 1, wherein: The connection electrode includes a detection portion disposed in the reaction chamber and a light emitting portion disposed in the signal chamber to form a whole.

3. The biosensor cartridge according to claim 2, wherein: The detection portion of the connection electrode surrounds at least a portion of the first electrode while being spaced apart from the first electrode by a predetermined distance. The light emitting portion of the connection electrode is arranged toward the second electrode, and the end portion thereof is tapered.

4. The biosensor cartridge according to claim 3, wherein: The connecting electrode is in a Y shape as a whole.

5. The biosensor cartridge according to claim 1, wherein: The electrode portion is formed in a circular shape. The outer portion of the partition portion is formed in a circular shape so as to correspond to the shape of the electrode portion.

6. The biosensor cartridge according to claim 1, wherein: The above divisions include: An outer wall, disposed at the outermost side of the partition, forming a side portion of the N reaction chambers; an inner wall, disposed on the inner side of the outer wall, dividing the signal chamber; and The partition plate extends from the inner peripheral surface of the outer wall to the outer peripheral surface of the inner wall, and N partition plates are arranged at intervals along the circumferential direction of the inner wall.

7. The biosensor cartridge according to claim 6, wherein: The outer wall and the inner wall are formed in a circular shape. The eight partitions are arranged at equal intervals to form eight reaction chambers between the inner wall and the outer wall.

8. The biosensor cartridge according to claim 7, wherein: The second electrode has an octagonal shape.

9. The biosensor cartridge according to claim 6, wherein: The inner wall is arranged so as to cross the N connection electrodes, and an insulator is arranged at a portion of the N connection electrodes where the inner wall is arranged.

10. The biosensor cartridge according to claim 1, wherein: The first electrode includes a support portion formed in a single closed curve shape and divided into N parts by the dividing portion.

11. The biosensor cartridge according to claim 10, wherein: The support portion is formed in a circular shape centered on the second electrode.

12. The biosensor cartridge according to claim 10, wherein: The first electrode further includes N reaction portions, which are formed to protrude from the support portion in a direction toward the second electrode. The N reaction parts are arranged one by one in the N reaction chambers.

13. The biosensor cartridge according to claim 12, wherein: The reaction part is formed into a circular shape. One end of the connection electrode surrounds the reaction portion while being spaced a predetermined distance from the reaction portion.

14. The biosensor cartridge according to claim 1, wherein: Different samples collected from separate individuals are introduced into the N reaction chambers.

15. The biosensor cartridge according to claim 1, wherein: The same sample collected from the same individual is introduced into the N reaction chambers, and different detection reagents are respectively introduced into the same sample in order to detect a plurality of biological substances.

16. The biosensor cartridge according to claim 1, wherein: The above-mentioned biological substance refers to a substance used to detect whether it is an infectious disease, a metabolic disease, an immune disease or a cancer, and is at least one of DNA, RNA, protein, metabolites, and extracellular vesicles.

17. A biosensor device, characterized in that: include: The biosensor cartridge according to any one of claims 1 to 16; The main body is formed with a receiving space in a manner of receiving the biosensor cartridge; a voltage applying section disposed on the housing space side of the main body section and applying a voltage to the electrode section side of the biosensor cartridge; and The image sensor unit is used to capture the electrochemical luminescence signal generated from the second chamber of the biosensor cartridge.

18. The biosensor device according to claim 17, characterized in that The above biosensor cartridge is disposable.

19. The biosensor device according to claim 17, wherein: The dividing portion includes at least one insertion protrusion protruding outward in a part thereof. The main body is formed with at least one insertion groove to insert and fix the insertion protrusion at a position corresponding to the insertion protrusion.

20. The biosensor device according to claim 17, wherein The invention further includes a magnetic force applying member, which is arranged at a position corresponding to the reaction chamber in the accommodation space of the main body in a manner of applying a magnetic force to the reaction chamber side.