JP4924932B2 - Biosensor cartridge, method of using biosensor cartridge, and biosensor device - Google Patents

Description

  The present invention relates to a biosensor cartridge, for example, a biosensor cartridge that measures and analyzes a chemical substance using a reagent contained in a hollow reaction part of a chip.

Conventionally, for example, a biosensor chip that detects the concentration of glucose in blood is known (see, for example, Patent Document 1).
FIG. 8 is an exploded perspective view showing the glucose sensor described in Patent Document 1. As shown in FIG. As shown in FIG. 8, a glucose sensor 100 that is a biosensor has a counter electrode 101 and a working electrode 102. The counter electrode 101 has a hollow needle shape half cut in the length direction, and a tip portion 103 thereof is obliquely cut into an injection needle shape so as to be easily punctured. The cut surfaces that have been cut are generally coated with insulating layers 104 and 104 'that also serve as adhesive layers, such as epoxy resin adhesives, silicone adhesives, or glass. The insulating layers 104 and 104' The working electrode 102 is attached via The working electrode 102 is a flat plate member to which glucose oxidase (GOD) is immobilized, and is adhered to the counter electrode 101 with the so-called immobilized GOD 105 surface side to which the GOD is immobilized facing inward.
Therefore, blood is collected by puncturing the subject 103 with the tip 103 of the needle-shaped counter electrode 101, and the reaction between the collected blood and the immobilized GOD 105 is detected by the working electrode 102 to determine glucose.

In addition, a biosensor in which a biosensor chip and a lancet are integrated is disclosed (see, for example, Patent Document 2).
9A is a perspective view of the sensor described in Patent Document 2, and FIG. 9B is an exploded perspective view of the sensor. As shown in FIG. 9, the lancet-integrated sensor 110 includes a chip body 111, a lancet 113, and a protective cover 115. The chip body 111 has a cover 111a and a substrate 111b that can be opened and closed, and an internal space 112 is formed on the inner surface of the cover 111a. The internal space 112 has a shape that can accommodate the lancet 113 in a movable manner.

  The needle 114 provided at the tip of the lancet 113 can be projected and retracted from an opening 112 a formed at the front end of the internal space 112 of the chip body 111 as the lancet 113 moves. The shape of the internal space 111a is curved so that the width thereof is slightly narrower than that of the lancet 113 at the end where the protrusion 113a is located, and the lancet 113 is locked to the chip body 111 by mutual pressing force and frictional force. It is like that. The protective cover 115 has a tube portion 115 a into which the needle 114 is inserted, and the tube portion 115 a can be accommodated inside the chip body 111 as the needle 114 moves. Therefore, in a state before use, the protective cover 115 is put on the needle 114 to protect the needle 114 and prevent the user from being accidentally injured. Note that the substrate 111b is provided with a pair of electrode terminals 116 so that it can be electrically connected to a biosensor device (not shown).

  In use, the protective cover 115 is removed and the lancet 113 is pushed to cause the needle 114 to protrude from the tip body 111. After puncturing the subject in this state, the needle 114 is housed inside the chip body 111, the opening 112a provided at the front end of the chip body 111 is brought close to the puncture port, and the outflowed blood is collected.

The biosensor disclosed in Document 3 has a needle-integrated structure in which an inspection chip is provided with a detection unit and a needle made of test paper, and the subject is punctured. This is a structure that uses a vacuum pump to collect blood to the detection unit later.
JP-A-2-120655 International Publication No. 02/056769 Pamphlet JP 2002-085384 A

However, in the glucose sensor 100 described in Patent Document 1, since the needle-like counter electrode 101 and the working electrode 102 are bonded to each other, the diameter of the puncture needle is approximately the same as the width of the glucose sensor 100 and increases. For this reason, there is a problem in that the amount of blood collected increases, pain during puncture increases, and the burden on the user increases.
In addition, the lancet-integrated sensor 110 described in Patent Document 2 has a structure that absorbs blood flowing out from the puncture port from the opening 112a, but the structure is complicated.
Furthermore, the biosensor described in Patent Document 3 also has a problem that the structure of the biosensor device is complicated, such as using a vacuum pump.

  The present invention has been made in view of the above-described problems, and an object of the present invention is to reduce the burden on the user by reducing the amount of sample collected for measurement and to bring the sample collection port closer to the puncture port. An object of the present invention is to provide a biosensor cartridge that can not only take a sample of a puncture opening and perform measurement without requiring an operation, but also enables more accurate measurement.

In order to achieve the above-described object, a first feature of the biosensor cartridge according to the present invention is a biosensor having a biosensor chip and a puncture device that is fixed to a part of the biosensor chip and has a tip protruding. A cartridge,
An elastic body having a sample collection port provided at the tip of the biosensor chip and a through hole that encloses a puncture port formed in the subject by the puncture device is provided at the tip of the biosensor chip, The elastic body includes an air passage that passes between an inner wall surface that forms the through hole and an outer wall surface of the elastic body.

In the biosensor cartridge configured in this way, when one end of the biosensor chip is pressed against the subject, the elastic body provided in a part of the biosensor chip is compressed and the puncture device protrudes. The subject can be punctured. Further, when the pressing force is weakened, the puncture device is extracted from the subject by the restoring force of the elastic body, and the sample flows out from the puncture port, and the sample can be collected.
Further, according to this biosensor cartridge, it is possible to prevent the puncture device from protruding from the distal end surface of the elastic body before use, thereby protecting the puncture device and protecting the user. it can. Furthermore, it is possible to prevent the puncture device from protruding from the distal end surface of the elastic body when it is discarded after use, and thus it can be safely and properly disposed of.

A second feature of the biosensor cartridge according to the present invention is that the biosensor cartridge according to the present invention is formed in the subject by the sample collection port provided at the tip of the biosensor chip and the puncture device. The puncture opening is connected to the through hole.
In the biosensor cartridge configured in this way, at the time of puncturing, the puncture port and the sample collection port provided at the tip of the biosensor chip are connected by a space formed by an elastic body, so even a small amount of sample can be used. A sample can be easily taken.

  The biosensor cartridge according to the third aspect of the present invention is the biosensor cartridge according to the first or second aspect of the present invention, wherein the elastic body has an inner diameter of a hole on the side in contact with the subject. It exists in being comprised larger than the internal diameter of the hole of the side in contact.

  In the biosensor cartridge configured as described above, since the opening of the through hole for sample collection is configured to be large, the positional relationship necessary for sample collection between the puncture port and the space of the elastic body is reliably maintained during puncture. Inadvertent contact between the sample and the elastic body is avoided, and the collected sample is guided to the biosensor chip without oozing out to the contact portion between the subject and the elastic body.

Further, a fourth feature of the biosensor cartridge according to the present invention is that, in the third feature of the present invention described above, on the side where the elastic body is in contact with the subject, the inner wall surface forming the through hole is elastic. It is a configuration that protrudes toward the tip of the body. Thereby, the sample in the through hole first comes into contact with the surface on which the inner wall surface is raised and is guided above the through hole.
The fifth feature of the biosensor cartridge according to the present invention is the first to fourth features of the present invention, wherein the ventilation path is a groove provided on an end surface of the elastic body on the subject side. That is to be configured.

  In the biosensor cartridge configured as described above, the ventilation path can be formed at the contact portion between the subject and the elastic body by the groove. Further, this groove is very easy to form and does not complicate the manufacture of the elastic body.

  According to a sixth aspect of the biosensor cartridge of the present invention, in the first to fourth aspects of the present invention, the vent path is an open through hole formed substantially along the radial direction of the elastic body. Is composed of

  In the biosensor cartridge configured as described above, the open through-hole is configured only by an elastic body without using the subject as a constituent element, so that the cross-sectional shape and the like can be easily set and the state of the subject can be set. It is not affected.

  Further, a seventh feature of the biosensor cartridge according to the present invention is that, in the first to sixth features of the present invention, a plurality of the air passages are formed in the elastic body, and the arrangement is elastic. That is, it is configured symmetrically in the elastic body radial direction around the center axis of the body.

  In the biosensor cartridge configured as described above, the arrangement of the air passages is symmetrical in the elastic body radial direction around the central axis of the elastic body, so that the elastic force of the elastic body is centered on the central axis. For example, when the elastic body is compressed, the balance of elasticity can be maintained evenly.

  An eighth feature of the biosensor cartridge according to the present invention is that, in any one of the first to seventh features of the present invention, the biosensor cartridge has a drive mechanism for puncturing the subject with the puncture instrument.

  In the biosensor cartridge configured as described above, the puncture device can be punctured into the subject by the drive mechanism, so that the puncture time can be shortened, and pain when collecting the sample can be reduced. Is possible.

  A ninth feature of the biosensor cartridge according to the present invention is that in any one of the first to eighth features of the present invention, the elastic body has adhesiveness. In particular, the surface in contact with the subject is preferably sticky, and when the material of the elastic body itself is sticky, or when the pressure sensitive adhesive is kneaded into the elastic body, a method of coating with a pressure sensitive adhesive can be mentioned. .

  In the biosensor cartridge configured as described above, since the elastic body has adhesiveness, the elastic body can be in close contact with the subject, and the sample can be reliably collected by preventing the puncture position from shifting. .

  A tenth feature of the biosensor cartridge according to the present invention is the biosensor cartridge according to any one of the first to ninth features of the present invention, wherein the elastic body adheres to the tip of the biosensor chip. Fixed with adhesive, or fixed with adhesive or double-sided tape.

  In the biosensor cartridge configured as described above, the elastic body can be reliably attached to the tip of the biosensor chip. When using a pressure-sensitive adhesive, if there is a gap between the elastic body and the biosensor chip, the adhesive can be applied so as to crush the gap, so that reliable bonding can be achieved and the sample is collected. Sample leakage can be prevented.

  The biosensor cartridge according to the present invention is characterized in that, in any of the first to tenth aspects of the present invention, the elastic body is punctured by pressing and compressing an elastic body against the specimen, and the elasticity The object is to extract the puncture device from the subject by the restoring force of the body and collect the sample while opening the through hole to the atmosphere.

  In such a method of using the biosensor cartridge, when one end of the biosensor chip is pressed against the subject, the elastic body provided at the one end of the biosensor chip is compressed and the puncture device protrudes. The subject can be punctured. Thereafter, the puncture device is pulled out by the restoring force of the elastic body, and the sample flowing out from the puncture port is collected from the sample collection port in the space formed by the elastic body. Therefore, after puncturing, the sample collection port is positioned at the puncture port. The sample can be reliably collected without any problems.

  The biosensor device according to the present invention is characterized in that the biosensor cartridge having any one of the first to tenth configurations of the present invention and a sample collected by connecting to the detection electrode of the biosensor cartridge And a measuring instrument for obtaining information.

  In the biosensor device configured as described above, since the sample is collected by the biosensor cartridge described above, the puncture and sample collection can be performed by a series of operations, and the sample collection port of the biosensor chip can be opened as in the past. It is not necessary to align with the puncture opening, and the sample can be collected easily and reliably. In addition, since information on the sample is transmitted to the measuring device via the detection electrode, the measurement can be easily performed in a short time, so that the burden on the subject can be reduced.

  According to the present invention, since the elastic body is provided at one end of the biosensor chip, after puncturing, the puncture device can be extracted by the restoring force of the elastic body, and a sample can be collected from an appropriate space formed by the elastic body. Therefore, even a small amount of sample can be easily collected by the sample collection port. Further, since the space for sampling the sample has an air passage that can be opened to the atmosphere, the sample can be stably introduced into the sample sampling port, and a biosensor cartridge capable of performing a reliable test, its method of use, and bio A sensor device can be provided.

DESCRIPTION OF EMBODIMENTS Hereinafter, embodiments according to the present invention will be described in detail with reference to the drawings.
1A is a longitudinal cross-sectional view (a cross-sectional view taken along the line AA in FIG. 1B) of a main part of an embodiment of the biosensor cartridge of the present invention as viewed from the side. (B) is a horizontal sectional view (sectional view at the position BB in FIG. 1 (A)) showing the main part of the embodiment of the biosensor cartridge of the present invention. FIG. 2 is an exploded perspective view showing an example of a joint portion between the biosensor chip and the elastic body. FIG. 3 is a cross-sectional view of the joint between the elastic body and the biosensor chip. FIG. 4 is a block diagram showing an embodiment of the biosensor device of the present invention. FIGS. 5A to 5C are a series of explanatory views showing a sample collecting operation using the biosensor device according to the present invention.

  As shown in FIGS. 1A, 1B and 2, a biosensor cartridge 10 according to an embodiment of the present invention is fixed to a biosensor chip 11 and one end portion 11a of the biosensor chip 11, and a tip 12a. Has a puncture device 12 protruding from the surface and an elastic body 20. That is, by pressing against the subject M, a sealed semi-open space 23 that encloses the sample collection port 13 provided at the tip 11a of the biosensor chip 11 and the puncture port formed in the subject M by the puncture device 12. Is formed at the tip 11 a of the biosensor chip 11.

  In the biosensor cartridge 10, as shown in FIGS. 2 and 3, the surface 25 of the elastic body 20 that contacts the biosensor chip 11 and the surface 11 a of the biosensor chip 11 that contacts the elastic body 20 are appropriately joined.

  The elastic body 20 has a groove 28 that forms a ventilation path that penetrates between the inner wall surface defining the sealed semi-open space 23 formed by the through hole 22 through which the puncture device 12 passes and the outer wall surface of the elastic body 20. I have.

  In the present invention, the puncture device 12 is a generic term for a needle, a lancet needle, a cannula, and the like, and is preferably made of a biodegradable material.

  The biosensor chip 11 has two substrates 16a and 16b facing each other, and a spacer layer 17 sandwiched between the two substrates 16a and 16b. 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, at one end (the lower end in FIG. 1A). Are bent in an L-shape in directions opposite to each other to maintain a predetermined interval.

  As shown in FIG. 3, the biosensor chip 11 has a hollow reaction portion 15 formed by two substrates 16 a and 16 b and a spacer layer 17 from the tip 11 a to a portion where the two detection electrodes 18 a and 18 b face each other. Is formed. Blood D (see FIG. 5C) as a sample collected by puncturing the subject M (see FIG. 5) with the puncture device 12 at the tip (bottom end in FIG. 3) of the hollow reaction portion 15. A sample collection port 13 to be introduced into the hollow reaction unit 15 is provided.

  That is, the hollow reaction part 15 is formed of 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 15, 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 15 in the blood D. A reagent 14 that reacts with glucose to generate an electric current is provided. Therefore, the hollow reaction part 15 is a part where the blood D such as blood collected from the sample collection port 13 undergoes a biochemical reaction with the reagent 14.

  As the material of the substrates 16a and 16b and the spacer layer 17, an insulating material film is selected. As the insulating material, ceramics, glass, paper, biodegradable material (for example, polylactic acid microorganism-producing polyester), poly Examples thereof include thermoplastic resins such as vinyl chloride, polypropylene, polystyrene, polycarbonate, acrylic resin, polybutylene terephthalate and polyethylene terephthalate (PET), thermosetting resins such as epoxy resins, and plastic materials such as UV curable resins. A plastic material such as polyethylene terephthalate is preferable because of its mechanical strength, flexibility, and ease of chip fabrication and processing. Representative PET resins include Melinex and Tetron (trade names, manufactured by Teijin DuPont Films, Inc.), Lumirror (trade names, manufactured by Toray Industries, Inc.), and the like.

Examples of the reagent 14 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 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, hydrophilic polymer, etc. as an additive in a chemical | medical agent.

As shown in FIGS. 2 and 3, the elastic body 20 attached to the tip 11 a of the biosensor chip 11 has, for example, a cylindrical shape having a through hole 22 for forming a sealed semi-open space 23 in the center. Can be illustrated. The through hole 22 is larger than the outer diameter of the puncture device 12 because the puncture device 12 is inserted therethrough.
The elastic body 20 is configured such that the inner diameter W2 of the through hole 22 which is the sealed semi-open space 23 on the side in contact with the subject M is larger than the inner diameter W1 of the hole on the side in contact with the biosensor chip 11.

The opening of the through hole 22 is configured to be large (with an inner diameter W2), and the so-called through hole 22 having a raised portion 26 in which the wall surface around the through hole 22 is raised is configured as an entrance. Thus, the blood D that has flowed into the sealed semi-open space 23 can be first brought into contact with the raised portion 26 around the through hole 22 and led to the through hole 22.
In this way, in the sealed semi-open space 23, the blood D is configured to be in a region close to the through hole 22 in the portion in contact with the inner wall surface, so that the blood D and the distal end surface 21 of the elastic body 20 are covered. It is possible to prevent oozing to the contact area with the specimen M.

  In addition, the thickness t of the elastic body 20 is configured to be able to reliably cover the tip of the puncture device 12.

The material of the elastic body 20 is not particularly limited as long as it has elasticity, but rubber such as silicone, urethane, acrylic rubber, rubber or sponge made of a single polymer or copolymerized polymer such as ethylene, styrene, Polyolefins such as polyethylene and polypropylene, polyesters such as polyethylene terephthalate and polybutylene terephthalate, fluororesins such as polytetrafluoroethylene and PFA which is a copolymer of perfluoroalkoxyethylene and polyfluoroethylene, and the like can be used.
The elastic body 20 may be solid or hollow as long as the air passage is formed.

  The distal end surface 21 that is a surface in contact with the subject M of the elastic body 20 is made of a material such as adhesive silicone rubber or acrylic rubber, or the elastic body has the adhesive 24 or is coated with the adhesive 24. It is desirable that The adhesive 24 is not particularly limited as long as the elasticity is not impaired. As a result, the adhesion between the elastic body 20 and the subject M can be improved, the displacement from the puncture position can be prevented, and the sealed semi-open space 23 can be reliably formed. Further, it is desirable that the inner peripheral surface of the through hole 22 is made of a hydrophilic material, or at least the inner peripheral surface is subjected to a hydrophilic treatment. Thereby, blood D to be collected can be easily passed, and even a small amount of blood D can be reliably collected.

As shown in FIG. 2, the tip 11a of the biosensor chip 11 and the upper surface 25 (lower side in FIG. 2) of the elastic body 20 are appropriately joined to the tip surface 21 (upper side in FIG. 2) of the elastic body 20. Two grooves 28 are formed so as to be symmetrical with respect to the axis C of the elastic body 20. The groove 28 can form a ventilation path to open the sealed semi-open space 23 to the atmosphere even when the distal end surface 21 is closed by the subject M.
The elastic body 20 does not have to be made of the same material for the inner wall surface forming the through-hole and the outer wall surface in contact with the subject, but it is preferable that the elastic body 20 is formed integrally to collect blood.

As shown in FIG. 3, it is desirable to securely fix the biosensor chip 11 and the elastic body 20 with an adhesive 27. At this time, in the case where a gap is formed between the elastic body 20 and the biosensor chip 11, the adhesion can be ensured by applying an adhesive so as to crush the gap. Moreover, it is possible to prevent blood D collected from the joint from leaking.
Note that when an adhesive is applied to the contact surface between the biosensor chip 11 and the elastic body 20, care should be taken so that it does not protrude into a portion that becomes a flow path for blood D, the inside of the biosensor chip 11, or the like. There is a need.

Next, the biosensor device according to the present invention will be described.
FIG. 4 shows a configuration of a biosensor device 30 using the biosensor cartridge 10 described above.
As shown in FIG. 4, the biosensor device 30 includes a biosensor cartridge 10 and a measuring instrument 31 that obtains information on blood D collected by connecting to the detection electrodes 18 a and 18 b of the biosensor cartridge 10. And a protective cap 36 for the biosensor cartridge. Note that the configuration of the biosensor cartridge 10 is as described above, and the same reference numerals are given to the portions common to the biosensor cartridge 10 described above, and the description thereof is omitted here.

  The measuring device 31 includes a power supply 32, a control device 33, a terminal insertion unit 34, and a display unit 35, which are connected to each other. The rear end portion 11b of the biosensor chip 11 of the biosensor cartridge 10 is inserted and fixed to the terminal insertion portion 34, and detection electrodes 18a and 18b exposed at the rear end portion 11c of the biosensor chip 11 are provided. It is designed to be electrically connected. The biosensor system 30 is small in size, for example, a handy type that a subject can hold with one hand.

Next, with reference to (A) to (C) of FIG. 5, a usage method will be described by taking as an example a case where a blood glucose level is measured using the biosensor device 30.
First, as shown in FIG. 4, the rear end portion 11 b of the biosensor chip 11 of the biosensor cartridge 10 is inserted into the terminal insertion portion 34 of the measuring instrument 31 and fixed and electrically connected. The power source 32 of the biosensor system 30 is turned on and it is confirmed whether or not it is normally activated.

  Then, as shown in FIG. 5A, the elastic body is attached to the tip 11a of the biosensor cartridge 10 by holding the biosensor device 30 and pressing the protective cap 36 against the subject to make the puncture site congested. 20 is brought into contact with the blood collection site of the subject M. Here, since the pressure sensitive adhesive 24 is coated on the front end surface of the elastic body 20, it is possible to prevent displacement in subsequent operations.

  Next, as shown in FIG. 5B, the biosensor cartridge 10 is pressed against the subject M. As a result, the elastic body 20 is crushed and the puncture instrument 12 protrudes from the tip of the elastic body 20 to puncture the subject M.

As shown in FIG. 5C, when the force for pressing the biosensor cartridge 10 is weakened, the elastic body 20 returns to the original state (the state shown in FIG. 5A) due to the restoring force. Can escape from the subject M, and the blood D coming out of the subject M can travel between the raised portion 26 of the through hole 22 and the puncture device 12 to collect the blood D.
At this time, in the through hole 22 including the puncture opening, the groove 28 is affected by the deformation of the elastic body 20, but it is not always necessary to collapse and completely close the hole. It is sufficient that the negative pressure is obtained even by a small amount due to the deformation. Thereafter, the through hole 22 is opened to the atmosphere by forming a ventilation path by the groove 28 by the restoration of the elastic body 20.

  Further, since the inner peripheral surface of the through hole 22 is subjected to a hydrophilic treatment, the blood D is collected from the sample collection port 13 along the inner peripheral surface of the through hole 22 due to the surface tension, capillary action, and the like. The collected blood D is introduced into the hollow reaction unit 15. At this time, since the sample collection port 13 is located in the sealed semi-open space 23 together with the puncture port formed by the puncture device 12, the blood D is collected easily and reliably without moving the biosensor cartridge 10. can do. For this reason, it can be used even with the subject M whose visual acuity has been lowered, and since it can be measured with a small amount of blood, the burden on the subject at the time of blood collection can be reduced. Further, since the sealed semi-open space 23 is blocked to some extent from the external air, the blood D is solidified so that it can be easily collected.

  When a predetermined amount of blood is collected, the biosensor device 30 is separated from the subject M, and the measurement result is displayed on the display unit 35. The blood D introduced into the hollow reaction unit 15 reacts with the reagent 14, and the current value or charge value (charge amount) data measured by the detection electrodes 18 a and 18 b is sent to the control device 33. A calibration curve data table is stored in the control device 33, and the blood sugar level is calculated based on the measured current value (charge value). When the calculation is completed, the measurement result is displayed on the display unit 35. For example, the blood glucose level can be expressed as a numerical value. Finally, the biosensor cartridge 10 is removed from the measuring instrument 31. At this time, since the elastic body 20 has returned to its original height, the puncture instrument 12 does not protrude from the tip 11a of the biosensor chip 11. ing. Thereby, the used biosensor cartridge 10 can be appropriately processed without the user being damaged by the puncture device 12.

  Puncturing may use a drive mechanism in addition to puncturing the biosensor cartridge 10 against the subject M. Examples of the drive mechanism for puncturing the subject with the puncture device include a spring and a motor. By using these drive mechanisms, the time required for puncturing can be shortened, and pain during puncturing can be reduced.

  In consideration of the blood collection burden of the subject, the volume of the hollow reaction part 15 is preferably 1 μL (microliter) or less, and particularly preferably 300 nL (nanoliter) or less. With such a minute hollow reaction part 15, even if the diameter of the puncture device 12 is small, a sufficient blood volume of the subject can be collected. Preferably, the diameter is 1000 μm or less.

  As described above, according to the biosensor cartridge 10 and the biosensor device 30 described above, when the one end 11a of the biosensor chip 11 is pressed against the subject M, the elastic body 20 is compressed and the puncture instrument 12 for puncture projects. Therefore, the subject M can be punctured. When the pressing force is weakened, the puncture device 12 is extracted from the subject M by the restoring force of the elastic body 20, and the blood D flows out from the puncture port. At this time, the puncture port and the sample collection port 13 provided at the tip 11a of the biosensor chip 11 are enclosed in the sealed semi-open space 23 of the elastic body 20, and after the puncture, the elastic body 20 returns to its original shape. To do. Moreover, since even a small amount of blood D can be easily collected and analyzed by the sample collection port 13, the burden on the subject M can be reduced.

  Further, by preventing the puncture device 12 from protruding from the distal end surface 21 of the elastic body 20 before use, the puncture device 12 and the user can be protected. Further, even when discarded after use, the puncture device 12 can be safely and properly disposed of by preventing it from protruding from the distal end surface 21 of the elastic body 20.

  In addition, puncture and sample collection can be performed by a series of operations, and it is not necessary to align the sample collection port 13 of the biosensor chip with the puncture port as in the prior art, and sample collection can be performed easily and reliably. it can. In addition, since the blood D information is transmitted to the measuring device 31 via the detection electrodes 18a and 18b, the measurement can be easily performed in a short time, so that the burden on the subject M 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, the case where the puncture device 12 is provided in the biosensor chip 11, that is, in the spacer layer 17 sandwiched between both the substrates 16 a and 16 b is illustrated, but the biosensor cartridge 10 of the present invention. Is not limited to this.

  For example, as shown in FIGS. 6A and 6B, the puncture device 12 can be provided along the outer surface of one substrate 16a. In the case of this biosensor cartridge 10B, the thickness of the biosensor chip 11 can be reduced to form the thin biosensor cartridge 10. However, since the puncture device 12 and the sampling port 13 are somewhat separated from each other, the cross-sectional shape of the through-hole 22 is made oval or the like, and the inside of the outer peripheral surface of the puncture device 12 and the through-hole 22 of the elastic body 20 It is desirable to make the gap formed between the peripheral surface as small as possible. In FIG. 6, parts that are the same as those of the biosensor cartridge 10 already described are denoted by the same reference numerals, and redundant description is omitted.

  In the embodiment described above, the case where the elastic body 20 is provided with the two grooves 28 has been described. However, the number of grooves is not limited to this, and a configuration as shown in FIG. You can also

  The configuration shown in FIG. 7 is a configuration in which an open through hole 29 that is a ventilation path is provided on the side surface of the elastic body 20. Further, the sealed semi-open space 23 is configured to have a raised portion 26 in which the wall surface around the through hole 22 is raised as in the above-described embodiment, but in this embodiment, the outer peripheral wall surface 26a of the raised portion 26 is provided. However, it is the structure which inclined suitably (it is also curving with inclination in this embodiment). That is, the tip of the raised portion 26 is pointed. According to such a configuration, blood D can be more effectively guided to the through hole 22.

  Furthermore, in the above-described embodiment, the case where the blood D is collected by the surface tension or capillary phenomenon has been described. However, for the application of the present invention, a device such as a pump that sucks up the blood D that has flowed out to the puncture port is used. I can. Further, the detection electrodes 18a and 18b are not L-shaped but may be linear as shown in FIG.

  As described above, since the biosensor cartridge according to the present invention is provided with an elastic body at the tip of the biosensor chip, after puncturing, the puncture instrument is extracted by the restoring force of the elastic body, and the sample is formed by the elastic body. Since the air flow when the sampling space changes from the negative pressure state to the open atmosphere can be used for sampling, even a small amount of sample can be easily collected by the sampling port, and it can be collected in the hollow reaction part of the chip. It is useful as a biosensor cartridge for measuring and analyzing chemical substances using the contained reagent. In addition, according to the present invention, it is possible to provide a method of using a biosensor cartridge and a biosensor device that can perform a reliable test.

(A) is explanatory drawing of the general | schematic longitudinal cross-section in embodiment of the biosensor cartridge which concerns on this invention. (B) is explanatory drawing of the general | schematic horizontal cross section in embodiment of the biosensor cartridge which concerns on this invention. It is a disassembled perspective view which shows the junction part of the elastic body and biosensor chip | tip in embodiment of the biosensor cartridge which concerns on this invention. It is sectional drawing which shows the junction part of the elastic body and biosensor chip | tip in embodiment of the biosensor cartridge which concerns on this invention. 1 is a schematic plan view showing an embodiment of a biosensor device according to the present invention. (A)-(C) are explanatory drawings which show the operation | movement which measures a blood glucose level using the biosensor apparatus concerning this invention. (A) is explanatory drawing which shows another embodiment of the biosensor cartridge which concerns on this invention. (B) is explanatory drawing which shows another embodiment of the biosensor cartridge which concerns on this invention. It is sectional drawing which shows the junction part of the elastic body and biosensor chip in another embodiment of the biosensor cartridge which concerns on this invention. It is a disassembled perspective view which shows the conventional biosensor chip. (A) is a perspective view which shows the conventional biosensor chip. (B) is an exploded perspective view showing a conventional biosensor chip.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Biosensor cartridge 11 Biosensor chip 11a One end part 12 Puncture device 12a Tip 13 Sample collection port 18a, 18b Detection electrode 20 Elastic body 22 Through-hole 21 Tip surface (surface in contact with subject)
23 Sealed semi-open space (space)
24 Adhesive 25 Surface in contact with biosensor chip 26 Raised portion 28 Groove (ventilation path)
29 Opening through hole (air passage)
30 Biosensor device 31 Measuring instrument D Blood (sample)
M subject

Claims (11)

A biosensor cartridge comprising a biosensor chip and a puncture device that is fixed to a part of the biosensor chip and has a protruding tip,
An elastic body having a sample collection port provided at the tip of the biosensor chip and a through hole that encloses a puncture port formed in the subject by the puncture device is provided at the tip of the biosensor chip,
The biosensor cartridge according to claim 1, wherein the elastic body includes a ventilation path that passes between an inner wall surface forming the through hole and an outer wall surface of the elastic body.   2. The bio according to claim 1, wherein a sample collection port provided at a tip of the biosensor chip and the puncture port formed in the subject by the puncture device are connected by the through hole. Sensor cartridge.   3. The biosensor cartridge according to claim 1, wherein the elastic body is configured such that an inner diameter of a hole in contact with the subject is larger than an inner diameter of a hole in contact with the biosensor chip.   4. The biosensor cartridge according to claim 3, wherein the elastic body has a configuration in which an inner wall surface forming the through hole is raised toward a tip of the elastic body on a side in contact with the subject.   The biosensor cartridge according to any one of claims 1 to 4, wherein the air passage is configured by a groove provided on an end surface of the elastic body on the subject side.   The biosensor cartridge according to any one of claims 1 to 4, wherein the ventilation path is configured by an open through hole formed substantially along a radial direction of the elastic body.   The said ventilation path is formed in two or more by the said elastic body, The arrangement | positioning was comprised symmetrically with the elastic body radial direction centering | focusing on the center axis line of this elastic body. The biosensor cartridge according to any one of the above.   The biosensor cartridge according to any one of claims 1 to 7, further comprising a drive mechanism for puncturing the subject with the puncture device.   The biosensor cartridge according to claim 1, wherein the elastic body has adhesiveness.   The said elastic body is fixed to the front-end | tip of the said biosensor chip with the adhesiveness of the elastic body itself, it is fixed with an adhesive agent, or it is fixed with the double-sided tape, It is characterized by the above-mentioned. The biosensor cartridge according to any one of the above. A biosensor comprising: the biosensor cartridge according to any one of claims 1 to 10; and a measuring instrument that obtains information on a sample collected by connecting to a detection electrode of the biosensor cartridge. apparatus.

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