KR20220130275A - Rapid bio diagnostic kit - Google Patents

Abstract

The present invention provides a rapid bio-diagnostic kit which comprises: a first substrate (100) having a first through-hole (103) formed in a part of a body (105); a second substrate (200) coupled to a lower surface of the first substrate (100), having a second through-hole (204) formed in the part of the body, and having a circuit pattern formed thereon; and a third substrate (300) coupled to a lower surface of the second substrate (200). The present invention can fundamentally block the leakage of an electrolyte solution through a positive electrode and a negative electrode in contact with the electrolyte solution.

Description

Rapid bio diagnostic kit

The present invention relates to a biodiagnostic kit, and more particularly, to a rapid biodiagnostic kit capable of fundamentally preventing leakage of an electrolyte solution.

A nanopore is a small hole (eg, having a diameter of about 1 nm to about 1000 nm) that can detect the flow of electrons through the hole by altering the ion current and/or the tunneling current.

Each nucleotide of a nucleic acid (e.g., adenine, cytosine, guanine, thymine, uracil of RNA) Measuring the change in current flowing through the nanopore can be used to directly sequence nucleic acid molecules passing through the nanopore, as it affects the current density across the nanopore in a specific way.

Nanopore technology is based on electrical sensing, which can detect nucleic acid molecules at much smaller concentrations and volumes than are required for other conventional sequencing methods.

1 schematically shows a solid-state based two-dimensional nanopore device according to the prior art.

In use, the nanopore device is disposed in an intermediate chamber separating the top and bottom chambers such that the top and bottom chambers are fluidly coupled by the nanopore pillars. The top, middle, and bottom chambers contain an electrolyte solution that holds charged particles (eg, DNA) to be detected. Different electrolyte solutions can be used for the detection of different charged particles.

A sensor including such a nanopore device is mounted on a diagnostic kit, and the electrical signal of the sensor is read by a reader.

2 illustrates the structure of a conventional diagnostic kit. Referring to FIG. 2, the conventional diagnostic kit forms an accommodation space 43 by stacking a plate 40 and a wall 41 on the upper surface of the plate 40, and a sensor including a nanopore device in the receiving space 43 ( 30) is seated, and the electrolyte solution containing the particles to be detected is put into the receiving space 43 and the receiving groove 44, and then the positive power supply 10 and the negative power supply 20 are partially (11, 21). When power is applied through the reader while exposed to the electrolyte solution, the electrolyte solution drawn by the power has a structure in which the nanopore device flows. In addition, an adhesive tape 42 is attached to the lower portion of the negative electrode 20 to prevent leakage of the electrolyte solution.

However, in the diagnostic kit having such a structure, there is a possibility that the electrolyte may leak through the positive electrode 10 or the negative electrode 20 . When the electrolyte solution leaks as described above, the reader is contaminated by viruses, for example, contained in the electrolyte solution, so that it is impossible to reuse the reader.

Therefore, there is a need for a biodiagnostic kit that can be reused without contaminating the reader and can stably supply or transmit electrical signals.

Domestic Patent Publication No. 10-2020-0086267 (published on July 16, 2020)

An object of the present invention is to provide a rapid biodiagnostic kit that can be reused without contaminating a reader and can stably supply or transmit an electrical signal.

The present invention provides a first substrate in which a first through hole is formed in a portion of a body; a second substrate coupled to a lower surface of the first substrate, a second through hole formed in a portion of the body, and a circuit pattern formed thereon; There is provided a rapid biodiagnostic kit comprising a third substrate coupled to a lower surface of the second substrate.

According to an embodiment, the electrolyte solution containing the sensing unit and the sample is accommodated through the first through hole.

According to an embodiment, the sensing unit includes a nanopore device.

According to an embodiment, a groove is formed on one wall surface of the first through hole, a copper foil circuit is coated or deposited on the surface of the groove to act as an anode, and a portion of the electrolyte solution accommodated in the first through hole is exposed to the anode.

According to an embodiment, a first electrolyte inlet through which an electrolyte solution can be injected and a first gas outlet through which gas can be discharged when electrolyte is injected are formed outside the first through hole of the first substrate.

According to an embodiment, a support portion is formed around the second through hole, the detection portion is seated on the support portion, and the circuit formed in the detection portion is wire-bonded with the circuit pattern of the second substrate formed around the support portion. bonding) method.

According to an embodiment, a copper foil circuit for connection with the anode is formed on the upper surface of the second substrate.

According to an embodiment, a cathode copper foil circuit serving as a cathode is formed on a lower surface of the second substrate.

According to an embodiment, a second electrolyte inlet and a second gas outlet are formed through the second substrate.

According to an embodiment, the second electrolyte inlet and the second gas outlet communicate with the first electrolyte inlet and the first gas outlet formed on the first substrate, respectively.

According to one embodiment, an electrolyte injection groove and a gas exhaust groove are formed in a portion of the body of the third substrate.

According to one embodiment, an electrolyte accommodating groove capable of accommodating an electrolyte solution is formed inside the third substrate.

According to one embodiment, the electrolyte receiving groove communicates with the electrolyte injection groove and the gas exhaust groove.

According to one embodiment, when the electrolyte is injected through the electrolyte injection groove, the gas existing inside the electrolyte receiving groove is discharged to the outside along the gas discharge groove, the electrolyte solution is accommodated in the electrolyte receiving groove.

According to an embodiment, the second substrate is formed to be longer in the longitudinal direction than that of the first and third substrates, and a connection portion capable of being coupled to a connector of a reader is formed on one side of the protruding second substrate. do.

According to an embodiment, the first substrate, the second substrate, and the third substrate are formed of a PCB material.

According to an embodiment, the PCB material may be any one of paper phenol, paper polyester, paper epoxy, glass paper epoxy, glass base epoxy, or glass cloth epoxy.

According to an embodiment, the first substrate, the second substrate, and the third substrate are firmly adhesively bonded by a multilayer PCB stacking method so that the electrolyte does not leak.

According to an embodiment, the first substrate and the third substrate may be thicker than the second substrate 200 .

According to an embodiment, an anode copper foil circuit acting as a cathode may be formed on the lower surface of the second substrate, so that the electrolyte solution accommodated in the electrolyte accommodating groove may be exposed to the cathode copper foil circuit.

The present invention has the effect of fundamentally blocking the leakage of the electrolyte solution through the positive electrode and the negative electrode in contact with the electrolyte solution.

The present invention has the effect of stably injecting the electrolyte into the electrolyte receiving groove.

In the present invention, leakage of the electrolyte solution through the bonding surface does not occur by using a plurality of PCB substrates as raw materials and manufacturing them by a multi-layer stacking method.

1 is a schematic diagram of a two-dimensional nanopore device according to the prior art.
Figure 2 is a schematic diagram of a conventional diagnostic kit.
3 is a perspective view of a biodiagnostic kit according to an embodiment of the present invention;
4 is a conceptual view of a front surface and a rear surface of a second substrate according to an embodiment of the present invention;
5 is a perspective view of a third substrate according to an embodiment of the present invention;
FIG. 6 a cutaway view along line AA of FIG. 3 .
7 is a real photograph of a bio-diagnostic kit before mounting a sensing unit according to an embodiment of the present invention.
8 is a real photograph of a bio-diagnostic kit after mounting a sensing unit according to an embodiment of the present invention.

Embodiments of the present disclosure are exemplified for the purpose of explaining the technical spirit of the present disclosure. The scope of the rights according to the present disclosure is not limited to the embodiments presented below or specific descriptions of these embodiments.

All technical and scientific terms used in this disclosure, unless otherwise defined, have the meanings commonly understood by one of ordinary skill in the art to which this disclosure belongs. All terms used in the present disclosure are selected for the purpose of more clearly describing the present disclosure and not to limit the scope of the present disclosure.

As used in this disclosure, expressions such as "comprising", "including", "having", etc. are open-ended terms connoting the possibility of including other embodiments, unless otherwise stated in the phrase or sentence in which the expression is included. (open-ended terms).

Expressions in the singular described in this disclosure may include the meaning of the plural unless otherwise stated, and the same applies to expressions in the singular in the claims.

Referring to FIG. 3 , the rapid biodiagnostic kit of the present invention includes a first substrate 100 having a first through hole 103 formed in a part of a body 105 , and coupled to a lower surface of the first substrate 100 , the body 105 . It includes a second substrate 200 having a second through hole 204 formed in a portion thereof and having a circuit pattern formed thereon, and a third substrate 300 coupled to a lower surface of the second substrate 200 .

The first substrate 100 has a thin rectangular plate shape. The first through-hole 103 formed in the body 105 of the first substrate 100 may receive an electrolyte solution containing a sensing unit 400 and a sample to be described later.

Here, the sample means a detection target solution, and is a substance suspected of containing an analyte. For example, the sample may include saliva, mucus, blood, cerebrospinal fluid, sweat, urine, ascites, and the like.

In addition, the specimen may be directly obtained from a biological source and used, or may be used after pre-treatment to modify the characteristics of the specimen. Pretreatment may include methods such as filtration, precipitation, dilution, mixing, concentration, inactivation of interfering components, lysis, addition of reagents, and the like.

The first through hole 103 may be obtained by perforating a portion of the body of the first substrate 100 . The shape of the first through hole 103 is not limited, but preferably, the first through hole 103 may have a rectangular cross-section.

The sensing unit 400 may be a biosensor including a nanopore device. The biosensor may receive power through a circuit pattern formed on the first substrate 100 or the second substrate 200 or may transmit a signal to a reader (not shown).

A groove 104 may be formed in one wall of the first through hole 103 . Preferably, the groove 104 may have a semicircular cross-section extending from the upper surface to the lower surface of the body 105 . A copper foil circuit may be coated or deposited on the surface of the groove 104 to act as an anode. Therefore, when the electrolyte solution is injected into the first through hole 103 , a part of the electrolyte solution may be exposed to the positive electrode.

On the outside of the first through hole 103 of the first substrate 100, the first electrolyte injection hole 101 through which the electrolyte solution can be injected, and the gas (particularly, air) present inside the substrate when the electrolyte is injected can be discharged. The first gas outlet 102 may be formed through.

Preferably, the shapes of the first electrolyte inlet 101 and the first gas outlet 102 are not limited as long as they can penetrate the first substrate 100 , and may preferably have a circular cross-sectional shape.

Referring to FIG. 4 , the upper surface of the second substrate 200 may be adhesively bonded to the lower surface of the first substrate 100 . The second substrate 200 may have a thin rectangular plate shape. Circuits or circuit patterns for supplying power from the reader and data communication with the reader may be formed on the upper and lower surfaces of the second substrate 200 .

A connection unit 207 capable of receiving power from the reader or exchanging data with the reader may be formed on one side of the second substrate 200 . For example, the connection unit 207 may be implemented in a form similar to a USB (Universal Serial Bus).

The second substrate 200 may be formed to be longer in the longitudinal direction than the first substrate 100 and the third substrate 300 . Therefore, the connection part 207 of the second board 200 can be formed to protrude from the first board 100 and the third board 300 , so that it can be easily combined with the connector of the reader.

A second through hole 204 may be formed in the body of the second substrate 200 . The second through hole 204 may be obtained by perforating a portion of the second substrate 200 . Preferably, the second through hole 204 may have a rectangular cross-section.

The area of the second through hole 204 may be narrower than that of the first through hole 103 formed in the first substrate 100 .

A support portion 205 in which a circuit pattern is not formed may be formed around the second through hole 204 . The sensing unit 400 may be seated on the support unit 205 . The circuit formed in the sensing unit 400 may be connected to the circuit of the second substrate 200 formed around the support unit 205 by wire bonding.

If the wire bonding portion is molded with epoxy, the sensing unit 400 may be firmly supported on the second substrate 200 and the wire bonding portion may be protected.

A copper foil circuit 203 for connection with an anode formed in the surface of the groove 104 of the first substrate 100 may be formed outside the support 205 .

Furthermore, a cathode copper foil circuit 206 acting as a cathode may be formed on a lower surface of the second substrate 200 corresponding to the support 205 . The negative copper foil circuit 206 may be exposed to the electrolyte solution by a method to be described later.

A second electrolyte inlet 201 and a second gas outlet 202 may be formed through the second substrate 200 . The shapes of the second electrolyte inlet 201 and the second gas outlet 202 are not limited as long as they can penetrate the second substrate 200 .

The second electrolyte inlet 201 and the second gas outlet 202 may communicate with the first electrolyte inlet 101 and the first gas outlet 102 formed in the first substrate 100, respectively.

Referring to FIG. 5 , an electrolyte injection groove 301 and a gas exhaust groove 302 may be formed in a portion of the body 304 of the third substrate 300 . An electrolyte receiving groove 303 capable of accommodating an electrolyte solution is formed in the third substrate 300 , and the electrolyte receiving groove 303 can communicate with the electrolyte injection groove 301 and the gas exhaust groove 302 . have.

The electrolyte injection groove 301 and the gas discharge groove 302 are ring-shaped, and the electrolyte receiving groove 303 may have a rectangular groove shape, but is not limited as long as the electrolyte flows or has a shape that can accommodate it.

When the electrolyte is injected through the electrolyte injection groove 301 , the gas existing inside the electrolyte receiving groove 303 is discharged to the outside along the gas discharge groove 302 , and the electrolyte solution can be accommodated in the electrolyte receiving groove 303 . have.

When the area of the electrolyte accommodating groove 303 is formed to be larger than the area of the negative copper foil circuit 206 formed under the second substrate 200 , the electrolyte solution accommodated in the electrolyte receiving groove 303 is exposed to the negative copper foil circuit 206 . can

Referring to FIG. 6 , the first substrate 100 , the second substrate 200 , and the third substrate 300 may be adhesively bonded to each other. More specifically, the lower surface of the first substrate 100 and the upper surface of the second substrate 200 are adhesively bonded, and the lower surface of the second substrate 200 and the upper surface of the third substrate 200 are adhesively bonded. can do.

The first substrate 100 , the second substrate 200 , and the third substrate 300 have the same width, but the second substrate 200 has a length compared to the first substrate 100 and the third substrate 300 . direction can be formed longer.

As described above, since the second substrate 200 is longer in the longitudinal direction than the first substrate 100 and the third substrate 300, a connection portion 207 may be formed on one side of the protruding second substrate 200, , the connector 207 can be easily combined with the connector of the reader.

Also, the first through hole 103 of the first substrate 100 and the second through hole 204 of the second substrate 200 may be coupled to exist at corresponding positions. Accordingly, the sensing unit 400 may be seated on the support unit 205 formed around the second through hole 204 of the second substrate 200 through the first through hole 103 of the first substrate 100 . .

The first electrolyte inlet 101 and the first gas outlet 102 of the first substrate 100 communicate with the second electrolyte inlet 201 and the second gas outlet 201 formed in the second substrate 300, respectively. can be combined. Further, the second electrolyte injection port 201 and the second gas discharge port 202 of the second substrate 200 are coupled to communicate with the electrolyte injection groove 301 and the gas discharge groove 302 of the third substrate 300 . can

Therefore, when the electrolyte solution is injected through the first electrolyte injection port 101, an injection flow path of the electrolyte solution is formed along the first electrolyte injection port 101, the second electrolyte injection port 201, and the electrolyte injection groove 301, The electrolyte solution may be accommodated in the electrolyte accommodating groove 303 , and a gas discharge path is formed along the first gas outlet 102 , the second gas outlet 201 , and the gas outlet groove 302 , so that the gas is discharged to the outside. can be

The first substrate 100 , the second substrate 200 , or the third substrate 100 may be formed of a general PCB material. That is, the first substrate 100, the second substrate 200, or the third substrate 100 is made of any one material of paper phenol, paper polyester, paper epoxy, glass paper epoxy, glass base epoxy, or glass cloth epoxy. can be formed.

Circuit patterns are not printed on the first substrate 100 and the third substrate 300 , but may be formed of a PCB material in order to improve assembly with the second substrate 200 and improve adhesion.

As above, the first substrate 100 and the third substrate 300 use a PCB material that is not coated with copper foil, and the second substrate 200 uses a PCB material on which a copper foil circuit is formed, so that the first, second, and third substrates are It can be firmly adhesively bonded by a known multi-layer PCB stacking method.

As in the present invention, when the first substrate 100 , the second substrate 200 , and the third substrate 300 use a PCB material and combine the substrates in a multilayer PCB stacking method, the electrolyte is applied to the first, second, and third substrates. (100, 200, 300) does not leak between the adhesive parts. Accordingly, even when the connection portion 207 of the second substrate 200 is connected to the reader, the reader is not contaminated and it is possible to reuse the reader.

The first substrate 100 and the third substrate 300 may be thicker than the second substrate 200 . Preferably, the first substrate 100 and the third substrate 300 may have a thickness of 1.6 mm, and the second substrate 200 may have a thickness of 1 mm.

Alternatively, the first substrate 100 and the third substrate 300 may have the same thickness or different thicknesses. That is, when the thickness of the sensing unit 400 is thick, the first substrate 100 may be thick to accommodate the sensing unit 400 . In addition, when it is necessary to accommodate a large-capacity electrolyte solution, the thickness of the third substrate 300 may be adjusted in proportion thereto.

As described above, the sensing unit 400 is fixed to the support unit 205 of the second substrate 200 through the first through hole 103 of the first substrate 100 , and the first through hole of the first substrate 100 is fixed. (103) An anode having a groove 104 shape is formed on one side wall surface, a cathode is formed on a lower surface of the second substrate 200, and an electrolyte receiving groove 303 formed by the cathode on the third substrate 300. Formed to be positioned inside, and when power is applied to the anode and the cathode, the electrolyte solution may move between the first through hole 103 , the sensing unit 400 , and the electrolyte receiving groove 303 .

7 shows an actual photograph of the bio-diagnostic kit according to the present invention before the sensing unit 400 is mounted.

8 shows an actual photograph of the biodiagnostic kit according to the present invention after the sensing unit 400 is mounted.

Although the above-described embodiments have been described with respect to the most preferred examples of the present invention, it is not limited to the above-described embodiments, and it is apparent to those skilled in the art that various modifications are possible without departing from the technical spirit of the present invention.

30: sensor
40: plate
41 : wall
42: adhesive tape
43: accommodation space
10, 20: positive, negative
100: first substrate
200: second substrate
300: third substrate
101: first electrolyte inlet
102: first gas outlet
103: first through hole
104: home
201: second electrolyte inlet
202: second gas outlet
203: copper foil circuit
204: second through hole
205: support
206: cathode copper foil circuit
207: connection part
301: electrolyte injection groove
302: gas exhaust groove
303: electrolyte receiving groove
400: sensing unit

Claims (20)

a first substrate having a first through hole formed in a portion of the body;
a second substrate coupled to a lower surface of the first substrate, a second through hole formed in a portion of the body, and a circuit pattern formed thereon;
and a third substrate coupled to a lower surface of the second substrate.
The rapid biodiagnostic kit according to claim 1, wherein the electrolyte solution containing the sensing unit and the sample is accommodated through the first through hole.
The rapid biodiagnosis kit according to claim 2, wherein the sensing unit is a biosensor including a nanopore device.
The method according to claim 2, wherein a groove is formed on one wall surface of the first through hole, a copper foil circuit is coated or deposited on the surface of the groove to act as an anode, and a part of the electrolyte solution accommodated in the first through hole is A rapid bio-diagnostic kit exposed to the anode.
The rapid biodiagnostic kit according to claim 1, wherein a first electrolyte inlet for injecting an electrolyte solution and a first gas outlet for discharging gas during electrolyte injection are formed outside the first through hole of the first substrate.
According to claim 3, wherein a support portion on which the detection unit is seated is formed around the second through hole, and the circuit formed in the detection portion is wire-bonded with the circuit pattern of the second substrate formed around the support portion. A rapid bio-diagnostic kit that is connected in a way.
The rapid biodiagnostic kit according to claim 4, wherein a copper foil circuit for connection with the anode is formed on the upper surface of the second substrate.
The rapid biodiagnostic kit according to claim 7, wherein a cathode copper foil circuit acting as a cathode is formed on the lower surface of the second substrate.
The rapid biodiagnostic kit according to claim 5, wherein the second electrolyte inlet and the second gas outlet 202 are formed through the second substrate.
The rapid biodiagnostic kit according to claim 9, wherein the second electrolyte inlet and the second gas outlet communicate with the first electrolyte inlet and the first gas outlet formed on the first substrate, respectively.
The rapid biodiagnosis kit according to claim 1, wherein an electrolyte injection groove and a gas exhaust groove are formed in a part of the body of the third substrate.
The rapid biodiagnostic kit according to claim 11, wherein an electrolyte accommodating groove capable of accommodating an electrolyte solution is formed inside the third substrate.
The rapid biodiagnosis kit according to claim 12, wherein the electrolyte receiving groove communicates with the electrolyte injection groove and the gas exhaust groove.
14. The rapid biodiagnostic kit according to claim 13, wherein when the electrolyte is injected through the electrolyte injection groove, the gas existing inside the electrolyte receiving groove is discharged to the outside along the gas discharge groove, and the electrolyte solution is accommodated in the electrolyte receiving groove. .
According to claim 1, wherein the second substrate is formed longer than the first substrate and the third substrate in the longitudinal direction, one side of the protruding second substrate is formed with a connection portion that can be coupled to the connector of the reader. , rapid bio-diagnostic kit.
The rapid biodiagnosis kit according to claim 1, wherein the first substrate, the second substrate, and the third substrate are formed of a PCB material.
The rapid biodiagnostic kit according to claim 16, wherein the PCB material is any one of paper phenol, paper polyester, paper epoxy, glass paper epoxy, glass substrate epoxy, and glass cloth epoxy.
The rapid biodiagnostic kit according to claim 17, wherein the first substrate, the second substrate and the third substrate are firmly adhesively bonded by a multilayer PCB stacking method so that the electrolyte does not leak.
The rapid biodiagnostic kit of claim 1 , wherein the first substrate and the third substrate are thicker than the second substrate.
The rapid biodiagnostic kit according to claim 12, wherein an anode copper foil circuit acting as a cathode is formed on the lower surface of the second substrate so that the electrolyte solution accommodated in the electrolyte accommodating groove can be exposed to the cathode copper foil circuit.

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