JP2008113771A - Biosensor cartridge - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a biosensor cartridge which achieves an inexpensive production while reducing burden on users by accurately drawing and analyzing a slight amount of sample. <P>SOLUTION: A closing member 20 is so arranged as to be opened outside only through a sample drawing port 14 while wrapping a biosensor chip 11. The closing member 20 is deformed to reduce the capacity of the internal space and then, released. As a result, the closing member 20 returns to the original shape by its return force. In the process, a negative pressure is generated inside the closing member 20 to cause a suction through the sample drawing port 14. So, puncturing is done with a device 12 for puncturing sticking out of the tip of the chip body 11 and then, likewise, a sample is sucked and drawn through the sample drawing port 14 provided at the tip of the biosensor chip 11 to be guided into a hollow reaction part 13. This enables the accurate drawing of even a small amount of sample, thereby reducing burden on users. In the manufacturing, the closing member 20 can be disposed outside any biosensor chip equivalent to that presently used, thereby achieving an easier and inexpensive production. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a biosensor cartridge that punctures a specimen, collects a sample, and performs measurement and analysis of the sample using a reagent accommodated in a hollow reaction part of a biosensor chip.

Conventionally, in order to analyze a characteristic component in a biological sample such as blood, a technique is known in which a sample is punctured with a puncture needle and the sample is collected (see, for example, Patent Documents 1 and 2).
As shown in FIG. 8, the bodily fluid collecting device 100 described in Patent Document 1 is similar to a dropper-like bodily fluid collecting container 102 having a bellows portion 101 and a puncture needle 103 housed in the bodily fluid collecting container 102. It has the electrode part 104 accommodated in the bodily fluid collection container 102, and the lead wire 105 connected with the electrode part 104. FIG. The rear end portion of the puncture needle 103 is fixed to the rear portion 102a of the body fluid collection container 102, and is provided toward the distal end of the dropper-like body fluid collection container 102. The tip portion 102b of the dropper-like body fluid collection container 102 has a hollow tubular shape, and the electrode portion 104 is fixed in the hollow tube. The rear end portion of the lead wire 105 connected to the electrode portion 104 forms a contact point 105 a in the rear portion 102 a of the body fluid collection container 102.

  Therefore, when collecting body fluid, the bellows portion 101 is first compressed in the distal direction, the puncture needle 103 is protruded from the tip of the body fluid collection container 102, and puncture is performed. Restore it with the restoring force of it, or extend it with external force. As a result, the inside of the body fluid collection container 102 is in a reduced pressure state, so that the body fluid flowing out from the puncture port formed by puncture is sucked and contacts the electrode unit 104. At the same time, the puncture needle 103 is accommodated in the body fluid collection container 102.

As shown in FIGS. 9A and 9B, the biosensor 110 described in Patent Document 2 includes an insulating substrate 111, an electrode 112 formed on the upper surface of the insulating substrate 111, and the electrode. A reagent layer 113 formed on the upper surface of 112 and an internal space forming portion 115 that covers the reagent layer 113 so as to form an internal space 114 in which the reagent layer 113 is exposed. A sample introduction port 116 for supplying a sample to the internal space 114 is provided at the tip of the internal space 114, and the internal space 114 communicates with the outside through only the sample introduction port 116. The internal space forming section 115 is provided with a negative pressure generating means 117 so that the negative pressure generating means 117 can generate a negative pressure in the internal space 114.
A method of collecting a sample using the biosensor 110 described in Patent Document 2 is as follows. That is, the negative pressure generating means 117 of the biosensor 110 is pressed in the state shown in FIG. 8A, and the volume of the internal space 114 is reduced to the state shown in FIG. Puncturing with a puncture device, releasing the pressing force and returning to the state shown in FIG. 8 (a), generates a negative pressure in the internal space 114, and sucks the sample from the sample introduction port 116 onto the electrode 112. It is made to react with the reagent layer 113 provided.
JP-A-9-108202 (FIG. 8) Japanese Patent Laid-Open No. 2000-121591 (FIG. 9)

By the way, conventionally, in order to accurately analyze a sample, it has been necessary to collect a certain amount of sample. Therefore, it is necessary for a user who collects a sample for frequent examination like a lifestyle-related disease test. There is a problem that the burden was large. For this reason, it has been desired to manufacture a biosensor chip that can be analyzed with a very small amount of sample at a low cost.
However, the bodily fluid collection device 100 described in Patent Document 1 includes the puncture needle 103 and the electrode unit 104 inside the bellows unit 101 and is not in the form of a sensor chip, so a sample collected for analysis. The problem of increasing the amount of was unable to be solved.
In addition, the biosensor 110 described in Patent Document 2 takes the form of a sensor chip, but it is difficult to reliably collect a small sample unless the chip itself is airtight, and the manufacturing is troublesome. There is an inconvenience that the cost increases.

  The present invention has been made in view of the above-described problems, and the purpose of the present invention is to reduce the burden on the user by reliably collecting and analyzing a small amount of sample, and can be manufactured at low cost. It is to provide a sensor chip.

    In order to achieve the above-mentioned object, the first feature of the biosensor cartridge according to the present invention is that a biosensor chip having a sample collection port for collecting a sample at the tip, and a tip fixed to a part of the biosensor chip A biosensor cartridge having a protruding puncture device including a sample collection port provided at a tip of the biosensor chip and a puncture port formed in a subject by the puncture device An elastic body is formed at the tip of the biosensor chip, encloses the biosensor chip, is in close contact with the elastic body, and is provided with a sealing member that opens to the outside only through the sampling port; and The sealing member is deformable.

  In the biosensor cartridge configured as described above, since the sealing member that includes the biosensor chip and opens to the outside only through the sampling port is provided, it is deformed so as to reduce the volume of the internal space of the sealing member. After that, when the sealing member is released, it tries to return to its original shape by its restoring force. At this time, a negative pressure is generated inside the sealing member, and the outside air is sucked from the sampling opening that is open to the outside. Therefore, the elastic body provided at the tip of the biosensor chip is compressed, and the biosensor chip After puncturing with the puncture device protruding from the tip of the sample, the sample is sucked from the sample collection port provided at the tip of the chip body and introduced into the hollow reaction part. For this reason, even a small amount of sample can be reliably collected, and the burden on the user can be reduced. Moreover, since it can manufacture by providing a sealing member in the outer side of the biosensor chip | tip similar to being used now, it can manufacture easily and cheaply.

  A second feature of the biosensor cartridge according to the present invention is that, in the first feature of the present invention, the sealing member and the elastic body are integrated.

  In the biosensor cartridge configured as described above, air can be prevented from leaking from between the sealing member and the elastic body, and a sample can be reliably collected. Moreover, it can be manufactured easily and inexpensively. The sealing member and the elastic body do not need to be made of the same material, but are preferably made of the same material because the sealing performance is further improved.

The biosensor cartridge according to the third aspect of the present invention is characterized in that a biosensor chip having a sample collection port for collecting a sample at the tip, and a puncture device that is fixed to a part of the biosensor chip and protrudes from the tip An elastic body that includes a sample collection port provided at a tip of the biosensor chip and a puncture port formed in the subject by the puncture device to form a sealed space, Provided at the tip of the biosensor chip,
The biosensor cartridge and the elastic body are covered with a deformable sealing member.

  In the biosensor cartridge configured as described above, since the biosensor cartridge and the elastic body are covered with the deformable sealing member, the internal space in the sealing member is depressurized to be in a vacuum state and sealed in the sealing member. By doing this, the biosensor cartridge can be stored until it is used without touching the outside air, and the user can use a clean biosensor cartridge. In use, the internal member in the sealing member is released from the reduced pressure by penetrating the sealing member with the piercing device. At this time, the sample flowing out from the puncture port of the specimen that has been punctured almost simultaneously is sucked from the sample collection port of the biosensor chip when the decompression of the sealed space is released and the negative pressure is reached.

  According to a fourth aspect of the biosensor cartridge of the present invention, in the biosensor cartridge according to any one of the first to third aspects of the present invention, an end of the sealing member on the puncture device side is provided. It has a cross section, and the other end has a closed shape.

  In the biosensor cartridge configured as described above, the end portion on the puncture device side is a cross section, and therefore, it is suitable for providing a puncture device and a sample collection port protruding from the chip body. Also, since the other end is closed, the detection electrode provided on the chip body protrudes and is sealed, and this detection electrode is connected to a measuring instrument for analysis and measurement. Is suitable. Furthermore, in the biosensor cartridge configured in this way, the sealing member has a shape in which one end is a cross section and the other end is closed, so that one end from the other end By pressing in the direction, it can be efficiently and easily deformed so as to reduce the volume of the internal space.

  According to a fifth aspect of the present invention, there is provided a sample collection method using the biosensor cartridge according to any one of the first to fourth aspects of the present invention, wherein the sealing member is disposed in the internal space. After deforming in the direction of decreasing the volume and puncturing the specimen with the puncture device, the external force that deforms the sealing member is removed, and the sealing member is restored to its original shape with a restoring force, so that the inside of the hollow reaction part In the sample collection method, a negative pressure is generated in the sample, and the sample is sucked and collected from the sample collection port.

  In the sample collecting method configured as described above, the sealing member is punctured by the puncture device provided at the tip of the chip body in a state where the volume of the internal space is reduced by deforming the sealing member, and then the sealing member The external force that is deforming is removed, and the sealing member is restored to its original shape by the restoring force, so that a negative pressure is generated in the hollow reaction part. For this reason, a sample is sucked and collected from a sample collection port provided at the tip of the hollow reaction part and opened to the outside, and introduced into the hollow reaction part. For this reason, even a small amount of sample can be reliably collected, and the burden on the user can be reduced.

  According to a sixth aspect of the present invention, there is provided a sample collection method using the biosensor cartridge according to the third or fourth aspect of the present invention, wherein the internal space of the sealing member is depressurized in advance. The puncture instrument penetrates the sealing member and punctures the specimen, and the sealing member is restored to its original shape by the restoring force released from the decompression of the sealing member, thereby causing negative pressure in the hollow reaction part. A pressure is generated, and a sample is sucked and collected from the sample collection port.

  In the sample collecting method configured as described above, by depressurizing the internal space of the sealing member in advance, when the puncture instrument penetrates the sealing member, the inside of the sealing member becomes negative, and the inside of the biosensor chip The hollow reaction part also becomes negative pressure. At this time, the sample flowing out from the puncture port of the specimen that has been punctured at the same time is sucked and collected into the hollow reaction part in the biosensor chip where the negative pressure has been reached, and even a small amount of sample can be collected quickly and reliably. Can reduce the burden on the user.

  According to the present invention, since the sealing member enclosing the biosensor chip and opening to the outside only through the sampling port is provided, the sealing member is deformed so as to reduce the volume of the internal space of the sealing member. When released, a negative pressure is generated inside the sealing member, and the sample is sucked from the sample collection port and introduced into the hollow reaction part. For this reason, even a small amount of sample can be reliably collected, and the burden on the user can be reduced. Moreover, since it can manufacture by providing a sealing member in the outer side of the biosensor chip | tip similar to being used now, it can manufacture easily and cheaply.

DESCRIPTION OF EMBODIMENTS Hereinafter, embodiments according to the present invention will be described in detail with reference to the drawings.
1 is a perspective view showing a first embodiment of the biosensor cartridge of the present invention, FIG. 2 (A) is a front view of a sealing member, and FIG. 2 (B) is a side view seen from the direction B in FIG. 2 (A). FIG. 2 (C) is a side view seen from the direction C in FIG. 2 (A), FIG. 3 (A) is a cross-sectional view taken along the line AA in FIG. 3 (B), and FIG. 3A is a cross-sectional view taken along the line B-B, FIG. 3C is a side view seen from the direction C in FIG. 3A, and FIG. 4A is a side view showing an example of a device for flattening the sealing member. FIGS. 4A and 4B are plan views of an instrument for flattening the sealing member, FIGS. 5A to 5E are process diagrams illustrating a sampling method, and FIG. 6 is a configuration diagram of a biosensor device.

As shown in FIG. 1, the biosensor cartridge 10 according to the first embodiment of the present invention has a puncture device 12 and a biosensor chip 11 provided with the puncture device 12 protruding from a tip 11a. Although 11 is not shown in FIG. 1, it has the sample collection port 14 for collecting a sample at the front-end | tip, and has the hollow reaction part 13 with which the sample extract | collected inside and the reagent 15 react. The biosensor chip 11 is included, and a sealing member 20 that is opened to the outside only through the sample collection port 14 is provided. The sealing member 20 reduces and restores the volume of the internal space. It can be deformed.
In the present invention, the puncture device is a needle, a lancet needle, a cannula or the like, and is preferably made of a biodegradable material.

  As shown in FIGS. 3A to 3C, the chip body 11 includes two substrates 16a and 16b facing each other and a spacer layer 17 sandwiched between the two substrates 16a and 16b. It has in the laminated state. Detection electrodes 18a and 18b are provided on the surface of at least one substrate 16a of the two substrates 16a and 16b on the spacer layer 17 side, and tips (lower ends in FIG. 3A) are mutually connected. It is bent in an L shape in the opposite direction to maintain a predetermined interval. A hollow reaction portion 13 is formed by the two substrates 16 a and 16 b and the spacer layer 17 from the tip 11 a of the chip body 11 to the portion where the two detection electrodes 18 a and 18 b face each other. At the tip of the hollow reaction part 13, there is a sample collection port 14 for introducing a sample R (see FIG. 5 (E)) collected by puncturing the specimen M (see FIG. 5) with the puncture device 12 into the hollow reaction part 13. Is provided. Note that at least one of the substrates 16a and 16b in the vicinity of the rear end portion of the hollow reaction portion 13 (the upper end portion in FIG. 3A) is a through hole 16c that allows the hollow reaction portion 13 and the outside of the substrates 16a and 16b to communicate with each other. Is provided.

That is, the hollow reaction part 13 is formed by the substrates 16a and 16b and the detection electrodes 18a and 18b on both upper and lower surfaces, and a rectangular space is formed with the spacer layer 17 cut into a predetermined shape as a side wall. For this reason, in the hollow reaction part 13, the detection electrodes 18a and 18b are exposed, and for example, an enzyme and a mediator are fixed immediately above or in the vicinity of the detection electrodes 18a and 18b in the hollow reaction part 13 in the blood R. A reagent 15 that reacts with glucose to generate an electric current is provided. Accordingly, the hollow reaction portion 13 is a portion where the sample R collected and received from the sample collection port 14 undergoes a biochemical reaction with the reagent 15.
As shown in FIG. 3C, at the rear end portion 11b of the chip body 11, the substrate 16a on which the detection electrodes 18a and 18b are provided protrudes from the spacer layer 17 and the other substrate 16b. It has been.

  Examples of the reagent 15 include enzymes such as glucose oxidase (GOD), glucose dehydrogenase (GDH), cholesterol oxidase, uricase, and electron acceptors. For example, in the case of a glucose biosensor chip that measures the amount of glucose in the blood, this portion includes a glucose oxidase layer, a glucose oxidase-electron acceptor (mediator) mixture layer, a glucose oxidase-albumin mixture layer, or a glucose oxidase-electron. A receptor-albumin mixture layer or the like is formed. These layers may be formed using enzymes other than glucose oxidase, such as glucose dehydrogenase. Moreover, you may include a buffering agent, a hydrophilic polymer, etc. in a chemical | medical agent as an additive.

  The volume of the hollow reaction part 13 is preferably 1 μL (microliter) or less, particularly preferably 300 nL (nanoliter) or less in consideration of the burden on the subject. With such a minute hollow reaction part 13, a sufficient blood volume of the subject can be collected even if the diameter of the puncture device 12 is small, and preferably the diameter is 1000 μm or less.

As shown in FIG. 3A, an elastic body 30 is attached to the tip 11a of the biosensor chip 11. The elastic body 30 can be exemplified by a cylindrical one having a through hole 32 for forming a sealed space 31 in the center. The through-hole 32 is larger than the outer diameter of the puncture device 12 because the puncture device 12 is inserted therethrough. Further, the thickness of the elastic body 30 is set to a thickness that can reliably cover the distal end 12a of the puncture device 12. The elastic body 30 is not particularly limited as long as it has elasticity, but rubber such as silicone, urethane, acrylic rubber or the like, rubber or sponge made of a single polymer or copolymerized polymer such as ethylene or styrene, polyethylene and polypropylene Polyolefin such as polyethylene, polyester such as polyethylene terephthalate and polybutylene terephthalate, polytetrafluoroethylene, and fluororesin such as PFA which is a copolymer of perfluoroalkoxyethylene and polyfluoroethylene can be used.
The elastic body 30 may be solid or hollow.

  It is desirable that the elastic body 30 is made of a material such as adhesive silicone rubber or acrylic rubber, or the elastic body has the adhesive 33 or is coated with the adhesive 33. Thereby, the adhesiveness between the elastic body 30 and the subject M can be improved, the displacement from the puncture position can be prevented, and the sealed space 31 can be reliably formed. Further, it is desirable that the inner peripheral surface of the through hole 32 is made of a hydrophilic material, or at least the inner peripheral surface is subjected to a hydrophilic treatment. Thereby, the sample R to be collected can be easily passed, and even a small amount of the sample R can be reliably collected.

As shown in FIG. 2, for the sealing member 20 including the biosensor chip 11, for example, a material that can be sealed and has elasticity such as silicone rubber can be used. The material of the sealing member 20 and the elastic body 30 can be used. The same material may be the same, and in the case of the same material, it can manufacture integrally. The end portion 21 on the puncture device side is open in cross section, and the other end portion 22 is closed, preferably in the form of a so-called toothpaste tube.
The sealing member 20 can be efficiently and easily reduced in volume of the internal space by pressing in the direction from the other end 22 toward the end 21 on the puncture device side (the direction of arrow A in FIG. 2A). Can be transformed into Further, since the end portion 21 on the puncture device side is a cross section, it is suitable for providing the puncture device 12 and the sample collection port 14 protruding from the biosensor chip 11. Further, since the other end 22 is closed, it is suitable for projecting the detection electrodes 18 a and 18 b provided on the rear end 11 b of the chip body 11 to the outside of the sealing member 20.

  The end 21 on the puncture device side is provided with a collar 21a. In the end portion 21 on the puncture device side, the sealing member except for the collar portion 21a is in close contact with the elastic body. The flange portion 21a is preferably sandwiched between the chip body 11 and the elastic body 30 so as not to leak air. The other end portion 22 is provided with a substrate 16a protruding rearward of the biosensor chip 11 and a rear opening portion 22a through which the rear end portions of the detection electrodes 18a and 18b can pass, so that air does not leak. To be sealed.

  In addition, although it is possible to deform | transform in the direction which reduces the internal volume of the sealing member 20 by pinching the sealing member 20 with a finger | toe and pressing it, it can also be deformed more completely using an instrument. As such an instrument 23, for example, as shown in FIG. 4, a pair of upper and lower arm members 24, 24 are rotatably connected, and a pair of rollers 25a, 25b are opposed to the tip of the arm member 24 so as to be rotatable. Can be provided. At this time, it is preferable that a stopper 26 is provided between the rollers 25a and 25b so as to maintain a constant distance larger than the thickness of the chip body 11 so that the chip body 11 is not excessively pressed. In such an instrument 23, the sealing member 20 can be flattened by pinching both arm members 24, 24 with fingers to bring both rollers 25 a, 25 b closer. It is also possible to provide a spring that urges the rollers 25a and 25b toward each other so that the sealing member 20 is crushed by the force of the spring. Alternatively, a spring that urges the rollers 25a and 25b in a direction to separate them is provided, and the arm member 24 and 24 are rotated in the opening direction by weakening the finger force to release the sealing member 20. Also good.

  Therefore, when the sealing member 20 is deformed in the direction of reducing the volume of the internal space, the gap between the rollers 25a and 25b is increased to sandwich the rear end portion 22 of the sealing member 20, and the upper and lower arm members 24 are sandwiched between fingers. Then, the sealing member 20 is pressed by both rollers 25a and 25b. In this state, the instrument 23 is moved to the distal end 21 side of the sealing member 20, and the air in the internal space of the sealing member 20 is expelled from the sampling port 14 and crushed. In addition, when both the rollers 25a and 25b are separated and the instrument 23 is removed, the sealing member 20 expands to the original shape by the restoring force. At this time, outside air is absorbed from the sampling port 14.

  In the biosensor cartridge 10 described above, since the sealing member 20 that includes the biosensor chip 11 and opens to the outside only through the sample collection port 14 is provided, the volume of the internal space of the sealing member 20 is reduced. When the sealing member 20 is released after being deformed, it tries to return to its original shape by its restoring force. At this time, since a negative pressure is generated inside the sealing member 20 and is sucked from the sample collection port 14, after puncturing with the puncture instrument 12 protruding from the tip 11 a of the biosensor chip 11, the biosensor chip 11 Blood R is sucked and collected from the sample collection port 14 provided at the tip 11a and introduced into the hollow reaction part. For this reason, even a small amount of blood R can be reliably collected, and the burden on the user can be reduced. Moreover, since it can manufacture by providing the sealing member 20 in the outer side of the same biosensor chip | tip currently used, it can manufacture easily and cheaply.

  Next, a biosensor cartridge according to a second embodiment of the present invention will be described. A biosensor cartridge according to a second embodiment of the present invention is shown in FIG. The same members as those in FIG. The biosensor cartridge of FIG. 7 is characterized in that both the biosensor cartridge 10 and the elastic body 30 are covered with a sealing member 20. In the biosensor cartridge having such a configuration, the internal space in the sealing member is depressurized to be in a vacuum state, and the sealing member 20 is sealed, so that the biosensor cartridge can be used without touching the outside air. It can be stored until time. In use, the internal member in the sealing member is released from the reduced pressure by penetrating the sealing member with the piercing device. At this time, the sample flowing out from the puncture port of the specimen that has been punctured simultaneously is inhaled from the sample collection port of the biosensor chip when the decompression of the sealed space is released and the negative pressure is reached. Therefore, even a small amount of sample R can be reliably collected, and the burden on the user can be reduced. Moreover, since it can manufacture by providing the sealing member 20 in the outer side of the same biosensor chip | tip currently used, it can manufacture easily and cheaply.

Next, referring to FIGS. 5A to 5C, a method for collecting blood for measuring blood glucose level using the biosensor chip 10 is described using the biosensor cartridge according to the first embodiment as an example. Explained.
From the original state shown in FIG. 5A, as shown in FIG. 5B, the sealing member 20 is deformed in a direction to reduce the volume of the internal space. At this time, the other end portion 22 which is the rear end portion of the sealing member 20 is sealed in a state where the substrate 16a and the detection electrodes 18a and 18b are protruded. It passes through the hollow reaction part 13 from the through holes 16c of 16a and 16b, and is discharged to the outside from the sample collection port 14 provided at the tip of the hollow reaction part 13.

  In the state of FIG. 5 (B), as shown in FIG. 5 (C), the elastic body 30 is brought into contact with the blood collection location of the subject M, and the biosensor cartridge 10 is pressed against the subject M. As a result, the elastic body 30 is crushed and the puncture device 12 protrudes from the tip of the elastic body 30 to puncture the subject M.

  Subsequently, as shown in FIG. 5D, the biosensor cartridge 10 is pulled up to remove the puncture device 12 from the subject M, and the external force (rollers 25a and 25b) that deforms the sealing member 20 is removed. At this time, the distal end surface 30 a of the elastic body 30 is not separated from the subject M. As a result, as shown in FIG. 5 (E), the sealing member 20 is restored to its original shape, and the internal space is expanded to generate a negative pressure, so that the through hole 32 of the elastic body 30 passes through the sampling port 14. Outside air is sucked into the hollow reaction part 13. At the same time, the sample R flowing out from the puncture port is sucked into the hollow reaction unit 13.

  In the sample sampling method configured as described above, since a negative pressure is generated in the hollow reaction portion by the restoring force of the sealing member 20 and the sample is sucked and collected, even a small amount of sample R can be reliably collected. , The burden on the user can be reduced.

The biosensor cartridge of the present invention is not limited to the embodiment described above, and appropriate modifications and improvements can be made.
For example, in the above-described embodiment, a so-called toothpaste tube shape is exemplified as the shape of the sealing member 20, but the shape can also be applied to other shapes.
It is also possible to reduce the pressure inside the sealing member 20 with a pump or the like and to suck and collect the sample R with the restoring force of the sealing member 20. In this case, the instrument 23 or the like for deforming the sealing member 20 is not necessary.

In the sample collection method described above, suction is started after the puncture device 12 is removed from the subject M. However, the sample may be sucked with the puncture device 12 punctured.
In the above-described sample collection method, when the blood R is collected, the sealing member 20 is flattened and then punctured. However, when the biosensor chip 10 is manufactured, it is flattened and the air hole is plugged in advance. The inside of the member 20 may be depressurized, and a stopper may be taken when the sample is collected. In this case, the instrument 23 for crushing the sealing member 20 is not necessary.

  Furthermore, as shown in FIG. 6, a measuring device 41 that obtains information on the collected blood R can be connected to the detection electrodes 18 a and 18 b of the biosensor chip 10 to obtain a biosensor device 40. The measuring instrument 41 includes a power source 42, a control device 43, a terminal insertion unit 44, and a display unit 45, which are connected to each other. The rear end portion 11b of the chip body 11 of the biosensor chip 10 is inserted and fixed in the terminal insertion portion 44, and the detection electrodes 18a and 18b exposed at the rear end portion 11c of the chip body 11 are electrically connected. To be connected to. When this biosensor system 40 is used, a series of operations such as puncture, sample R collection, and analysis can be performed in a short time, and the burden on the user can be reduced.

  As described above, when the biosensor cartridge according to the present invention is deformed so as to reduce the volume of the internal space of the sealing member and then the sealing member is released, a negative pressure is generated inside the sealing member, and the sample sampling port Since the sample is sucked and collected and introduced into the hollow reaction part, even a small amount of sample can be reliably collected, and the burden on the user can be reduced. Moreover, since it can be manufactured by providing a sealing member on the outside of the same biosensor chip as currently used, it has the effect that it can be manufactured easily and inexpensively, and a sample is collected by puncturing the sample. It is useful as a biosensor cartridge or the like for measuring and analyzing a sample using a reagent accommodated in the hollow reaction part of the chip.

It is a perspective view which shows 1st Embodiment which concerns on the biosensor cartridge of this invention. (A) is a front view of a sealing member. (B) is the side view seen from the B direction in FIG. 2 (A). (C) is the side view seen from the C direction in FIG. 2 (A). (A) is sectional drawing of the AA position in FIG.3 (B). (B) is sectional drawing of the BB position in FIG. 3 (A). (C) is the side view seen from C in FIG. 3 (A). (A) is a side view which shows an example of the instrument which crushes a sealing member. (B) is a top view of an instrument. (A)-(E) are process drawings which show the sampling method which concerns on this invention. It is a block diagram of a biosensor apparatus. It is a perspective view which shows 2nd Embodiment which concerns on the biosensor cartridge of this invention. It is sectional drawing which shows the conventional biosensor. It is sectional drawing which shows the conventional biosensor.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Biosensor cartridge 11 Biosensor chip 11a Tip 12 Puncture instrument 13 Hollow reaction part 14 Sample collection port 15 Reagent 20 Sealing member 21 End part on puncture instrument side 22 The other end R Sample

Claims (6)

A biosensor cartridge having a biosensor chip having a sample collection port for collecting a sample at the tip, and a puncture device fixed to a part of the biosensor chip and protruding from the tip,
An elastic body that encloses a sample collection port provided at the tip of the biosensor chip and a puncture port formed in the subject by the puncture device to form a sealed space is provided at the tip of the biosensor chip;
A biosensor including the biosensor chip, provided with a sealing member that is in close contact with the elastic body and opens to the outside only through the sampling port, and the sealing member is deformable cartridge.   The biosensor cartridge according to claim 1, wherein the sealing member and the elastic body are integrated. A biosensor cartridge having a biosensor chip having a sample collection port for collecting a sample at the tip, and a puncture device fixed to a part of the biosensor chip and protruding from the tip,
An elastic body that encloses a sample collection port provided at the tip of the biosensor chip and a puncture port formed in the subject by the puncture device to form a sealed space is provided at the tip of the biosensor chip;
A biosensor cartridge, wherein the biosensor cartridge and the elastic body are covered with a deformable sealing member.   The biosensor cartridge according to any one of claims 1 to 3, wherein the end of the sealing member on the side of the puncture device has a cross section, and the other end is closed. A method for collecting a sample using the biosensor cartridge according to any one of claims 1 to 4,
After the sealing member is deformed in the direction of reducing the volume of the internal space, the specimen is punctured by the puncture device, and then the external force that is deforming the sealing member is removed, and the sealing member is restored to its original shape by a restoring force. A sample collecting method, wherein a negative pressure is generated in the hollow reaction part by restoring the sample, and the sample is sucked and collected from the sample collection port. A method for collecting a sample using the biosensor cartridge according to claim 3 or 4,
The internal space of the sealing member is depressurized in advance, the puncture instrument penetrates the sealing member and punctures the specimen, and the sealing member is restored to its original shape with a restoring force that releases the depressurization of the sealing member. A sample collecting method, wherein a negative pressure is generated in the hollow reaction part by restoring the sample to suck and sample the sample from the sample collection port.

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