JP2008125754A - Biosensor cartridge, method of using biosensor cartridge, and biosensor device - Google Patents

Abstract

[PROBLEMS] To reduce the burden on the user by reducing the amount of sample collected for measurement, and easily collect the sample from the puncture port without the need to move the sample collection port close to the puncture port. A biosensor cartridge that can be provided is provided.
One end of a biosensor chip 11 is pressed against a subject M, punctured with a puncture device 12 protruding from a sealed half-open space 23 of an elastic body 20, and immediately after the puncture, the volume of the elastic body 20 is expanded. The puncture device 12 is extracted from the subject M, and the sample B is caused to flow out from the puncture port. At this time, since the puncture port and the sample collection port 13 provided in the biosensor chip 11 are contained in the sealed semi-open space 23 formed by the expanded elastic body 20, even a small amount of sample B can be collected easily. be able to.
[Selection] Figure 1

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 the substrate 111b can be electrically connected to a measuring apparatus (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.

JP-A-2-120655 WO02-056769

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.

  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. It is an object of the present invention to provide a biosensor cartridge that can easily collect and measure a sample of a puncture opening without requiring an operation.

  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. An elastic body that is a cartridge and includes a sample collection port provided at a tip of the biosensor chip and a puncture port formed in a subject by the puncture device to form a space necessary for sample collection, The elastic body is provided at the tip of the biosensor chip, and the elastic body has an internal space in which the internal pressure can be varied, and is configured to be volume-expanded by an increase in the internal pressure of the internal space.

In the biosensor cartridge configured as described above, a puncture device that protrudes from between elastic bodies provided in a part of the biosensor chip by pressing one end of the biosensor chip against the subject After that, the elastic body expands in volume in the direction of removing the tip of the puncture device from the subject due to an increase in internal pressure of the internal space, so that the puncture device is extracted from the subject and puncture is performed. The sample flows out from the mouth, and the sample can be introduced into the sampling port.
In addition, according to this biosensor cartridge, it is possible to prevent the puncture device from protruding from the distal end surface of the elastic body even when it is discarded after use, and thus it can be disposed of safely and appropriately.

  A second feature of the biosensor cartridge according to the present invention is that, in the first feature of the present invention described above, puncture interlocking means that operates in response to the puncture operation of the puncture device is provided, The internal pressure fluctuation is configured to be performed by the puncture interlocking means. With this configuration, the puncture device can be quickly and effectively removed from the subject in conjunction with the puncture operation.

  A third feature of the biosensor cartridge according to the present invention is that, in the first or second feature of the present invention, the internal space is configured in an annular shape surrounding a space necessary for sampling. It is in. With this configuration, the elastic member has a uniform and stable expansion operation in the direction in which the tip of the puncture device is removed from the subject.

Further, a fourth feature of the biosensor cartridge according to the present invention is that, in the third feature of the present invention, the puncture interlocking means is constituted by a pressure sensor that senses an impact of the puncture operation of the puncture device. There is. With this configuration, the elastic member detects the pressure when the tip of the puncture device is pierced by the subject, so that an expansion operation for removing the tip immediately after the puncture operation can be started by this detection.

A fifth feature of the biosensor cartridge according to the present invention is that, in the first to fourth features of the present invention described above, the biosensor cartridge has a drive mechanism for puncturing the subject with the puncture device. is there.
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 sixth feature of the biosensor cartridge according to the present invention is that, in the first to fifth features of the present invention, the puncture interlocking means is configured to interlock with the drive mechanism. With this configuration, in conjunction with the puncturing drive mechanism, an expansion operation for removing the tip can be started almost immediately after the tip of the puncture device is stabbed into the subject.

A seventh feature of the biosensor cartridge according to the present invention is that in any one of the first to sixth features of the present invention, the elastic body has adhesiveness. In particular, it is preferable that the surface in contact with the subject has adhesiveness, and when the material of the elastic body itself has adhesiveness, or when the adhesive is kneaded into the elastic body, a method of coating with the adhesive is included. .

  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. .

  Further, an eighth feature of the biosensor cartridge according to the present invention is that in any one of the first to ninth features of the present invention, the elastic body has an adhesive property of the elastic body itself at a 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 is securely 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.

  In addition, the biosensor cartridge according to the present invention is characterized in that the biosensor cartridge according to any one of the first to eighth aspects of the present invention is punctured by pressing an elastic body against the specimen, The elastic body is expanded by its internal pressure increase, and the puncture device is extracted from the subject to collect a sample.

  In such a method of using the biosensor cartridge, one end of the biosensor chip is pressed against the subject, and the puncture device provided on the biosensor chip punctures the subject. The puncture device is removed, and the sample that flows out from the puncture port is collected from the sample collection port in the space formed by the elastic body. Therefore, after puncture, the sample is collected without positioning the sample collection port at the puncture port. can do. In addition, since analysis can be performed with a small amount of sample, the burden on the subject can be reduced.

  The biosensor device according to the present invention is characterized in that the biosensor cartridge having any one of the first to eighth 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, by transmitting the sample information 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 capable of volume expansion is provided at one end of the biosensor chip, the puncture device is extracted by the force with which the elastic body expands after puncturing, and formed by the elastic body continuously with this extraction operation. Since a sample can be collected from the appropriate space, even a small amount of sample can be easily collected by the sample collection port. In addition, according to the present invention, it is possible to provide a biosensor cartridge, a method of using the same, and a biosensor device that can perform a reliable test.

DESCRIPTION OF EMBODIMENTS Hereinafter, embodiments according to the present invention will be described in detail with reference to the drawings.
FIG. 1A is a longitudinal cross-sectional view (a cross-sectional view taken along the line AA in FIG. 1B) as viewed from the side in an expanded state of the elastic body in the embodiment of the biosensor cartridge of the present invention. FIG. 1B is a horizontal cross-sectional view (a cross-sectional view taken along the line BB in FIG. 1A) showing the main part of the embodiment of the biosensor cartridge of the present invention. FIG. 2 is an exploded perspective view of a partial cross section of the biosensor chip and the elastic body. FIG. 3 is an enlarged cross-sectional view of a main part of the elastic body and the biosensor chip before expansion. 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 protruding puncture device 12 and an expandable elastic body 20 (shown in an expanded state in FIG. 1). As will be described in detail later, when the elastic body 20 is operated so as to be pressed against the subject M, the elastic body 20 expands after the tip 12a punctures the subject M, so that the tip 11a of the biosensor chip 11 is expanded. A sealed semi-open space 23 is formed that encloses the sample collection port 13 provided in the puncture device 12 and the puncture port formed in the subject M by the puncture device 12. Further, the spring means 50 can be used as a drive mechanism when the biosensor cartridge 10 is punctured into the subject M. By using this drive mechanism, the time required for puncturing can be shortened, and pain during puncturing can be reduced.
2 and 3, in the biosensor cartridge 10, a surface 25 of the elastic body 20 that contacts the biosensor chip 11 and a surface 11a of the biosensor chip 11 that contacts the elastic body 20 are appropriately joined ( The elastic body 20 shown in FIGS. 2 and 3 is in a state before expansion).

The elastic body 20 is formed with a sealed semi-open space 23 through which the puncture device 12 passes. That is, a space necessary for sample collection is formed by including a puncture port formed in the subject M by the sample collection port 13 provided at the tip of the biosensor chip 11 and the puncture device 12. Further, the elastic body 20 includes an internal space 20A. The internal pressure of the internal space 20A rises when the gas generating means 20B is activated (the state in FIG. 1 indicates the state after being activated). The elastic body 20 expands in volume by the pressure increase in the internal space 20B. That is, the initial thickness t (see FIGS. 2 and 3) from which the tip 12a of the puncture device 12 protrudes becomes the expansion thickness T (see FIG. 1), and the tip 12a of the puncture device 12 is pulled out from the subject M. Can work. The internal space 20 </ b> A is configured in an annular shape surrounding the sealed semi-open space 23.
The elastic body 20 is provided with a pressure sensor 28 that functions as a puncture interlocking unit that operates in response to the puncture operation of the puncture device 12. The pressure sensor 28 and the gas generating means 20B are appropriately connected via a control device 33 of the biosensor device 30 (see FIG. 4).
The gas generating means 20B is not particularly limited as long as it has a function of generating gas, but a well-known one applied to an inflator or the like of a vehicle airbag can be used. That is, for example, it can be configured to have sodium nitride nitrite as the gas generating agent, boron potassium nitrate as the igniting agent, and a heater and zirconium perchloric acid as the ignition means.

  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 (FIG. 1 and FIG. 5C) as a sample collected by puncturing the subject M (see FIG. 5) with the puncture device 12 at the tip (lower end in FIG. 3) of the hollow reaction part 15 A sampling port 13 is provided for introducing the gas into the hollow reaction part 15.

  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 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.

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 has an inner diameter W1 that is larger than the outer diameter of the puncture device 12 since the puncture device 12 is inserted therethrough. The inner wall surface defining the sealed semi-open space 23 has an opening inner diameter W2 on the subject M side larger than an inner diameter W1 of the through hole 22 when the elastic body 20 is expanded, as shown in FIG. It is configured as follows.
This is because the front opening of the sealed semi-open space 23 is configured to be large, so that the positional relationship required for sampling the sample D can be reliably maintained between the puncture port and the open space of the elastic body 20. Moreover, the unexpected contact with the sample D and the elastic body 20 is avoided, and the sample D is led to the hollow reaction part 15 of the biosensor chip 11 without oozing out to the contact part.
Further, the sealed half-open space 23 has a so-called through-hole 22 in which the so-called through-hole 22 has a raised portion 26 in which the wall surface around the through-hole 22 is raised. According to such a configuration, the blood D that has flowed out into the sealed semi-open space 23 first comes into contact with the raised portion 26 around the through hole 22 and is guided to the through hole 22.
Further, when the elastic body 20 expands due to a pressure increase in the internal space 20 </ b> A, the thickness t becomes an expansion thickness T that covers 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 distal end surface 21 which 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 20 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. When the pressure sensor 28 provided on the upper side contacts the subject M, the pressure sensor 28 senses the pressure or impact and sends the signal to the control device 33. The gas generating means 20B is activated based on the signal from the control device 33.

As shown in FIG. 3, it is desirable to securely fix the biosensor chip 11 and the elastic body 20 with an adhesive. 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. Thereby, it can prevent that the blood D extract | collected from the junction part leaks.
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 terminal insertion portion 34 is inserted with the rear end portion 11b of the biosensor chip 11 of the biosensor cartridge 10 and is fixed via the spring means 50, and is also exposed to the rear end portion 11c of the biosensor chip 11. The electrodes 18a and 18b are electrically connected. The biosensor device 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 device 30 is turned on and it is confirmed whether it is normally activated.
Then, as shown in FIG. 5A, the biosensor device 30 is held and pressed against the subject M (in the direction of the arrow X). Then, as shown in FIG. 5B, after the protective cap 36 is pressed against the subject to make the puncture site congested, the spring means 50 is operated by an operation button (not shown) or the like provided on the biosensor device 30. Let As a result, the biasing force of the spring means 50 acts, and the biosensor cartridge 10 punctures the blood collection site of the subject M with the puncture device 12 attached to the tip 11a.
Here, since the adhesive 24 is coated on the distal end surface of the elastic body 20, the elastic body 20 can be in close contact with the subject M to prevent displacement.

  As shown in FIG. 5B, when the tip 12a of the puncture device 12 punctures the subject M, the pressure sensor 28 detects the puncture state by the collision with the subject M. As a result, the gas generating means 20B is activated to generate gas. As a result, the elastic body 20 expands as shown in FIG.

In this way, the volume of the elastic body 20 expands due to the increase in internal pressure of the internal space 20A, and the thickness becomes the expanded thickness T due to this expansion, so that the tip 12a of the puncture device 12 comes out of the subject M, and the puncture port Blood D flows out from The blood D that has flowed into the sealed semi-open space 23 first contacts the raised portion 26 around the through hole 22, and the blood D is collected from the sample collection port 13 along the inner peripheral surface of the through hole 22. Is done.
In addition, since the inner peripheral surface of the through-hole 22 is hydrophilically treated here, the blood D is collected from the sampling port 13 along the inner peripheral surface of the through-hole 22 by its surface tension and capillary phenomenon. It is introduced into the hollow reaction part 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, a series of blood D can be easily and reliably transferred without moving the biosensor cartridge 10. It can be collected by the operation. Thereby, even a user (subject M) whose visual acuity has deteriorated can be used very easily. In addition, since measurement can be performed with a small amount of blood D, the burden on the subject during blood collection can be reduced. Furthermore, since the sealed semi-open space 23 is shielded to some extent from the external air, the blood D can be delayed in coagulation and collected easily.

When a predetermined amount of blood D 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 device 31. Since the elastic body 20 maintains the expanded size at the time of removal, the puncture device 12 does not protrude from the tip 11a of the biosensor chip 11. Thereby, a user can also be prevented from being damaged by the puncture device 12, and the used biosensor cartridge 10 can be processed safely.
In the present embodiment, the puncture with the puncture device 12 may use a motor, an air spring, or the like in addition to the drive mechanism using the spring means 50.

  In consideration of the blood collection burden of the subject M, 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, the distal end 12a is punctured by pressing the one end 11a of the biosensor chip 11 against the subject M, and the elastic body 20 expands for puncture. The tip 12a of the instrument 12 is extracted from the subject M, and blood D flows out from the puncture opening. At this time, since the puncture port and the sample collection port 13 provided at the tip 11a of the biosensor chip 11 are contained in the sealed semi-open space 23 of the elastic body 20, the blood D is discharged from the minute puncture port after puncture. Can be reliably collected, and pain of the subject M can be reduced. In addition, since a small amount of blood D can be easily collected and analyzed by the sample collection port 13, the burden on the subject M is small.

  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 configuration in which the gas generating means 20B is provided in the internal space 20A of the elastic body 20 has been described. However, as shown in FIG. It can also be set as the structure which connects the space 20A with the gas supply path 29. FIG. The puncture interlocking means is not limited to the pressure sensor 28, and any electric sensor or mechanical operation mechanism may be employed as long as it has a function capable of detecting the puncture operation. However, the present invention is not limited to the above-described embodiment, and can be installed at appropriate places as necessary. Moreover, the structure which does not have a drive mechanism like the spring means 50 may be sufficient.

  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 the expandable elastic body at the tip of the biosensor chip, immediately after the puncture operation, the puncture device is extracted by the expansion of the elastic body, and formed by the elastic body. The sampled space is used for sampling, so even a small amount of sample can be easily and reliably collected by the sampling port, and chemical substances can be measured and analyzed using the reagent contained in the hollow reaction part of the chip. It is useful as a biosensor cartridge to be used. 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), (B), (C) is explanatory drawing which shows 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 a schematic longitudinal cross-section of the principal part in other 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 instrument 12a Tip 13 Sample collection port 18a, 18b Detection electrode 20 Elastic body 20A Internal space 22 Through hole 21 Tip surface (surface in contact with subject)
23 Sealed semi-open space (space)
24 Adhesive 25 Face in contact with biosensor chip 26 Raised portion 28 Pressure sensor (puncture interlocking means)
29 Opening through hole (air passage)
30 Biosensor device 31 Measuring instrument 50 Spring means (drive mechanism)
D Blood (sample)
M subject

Claims (10)

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 that includes 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 space necessary for sample collection is provided at the tip of the biosensor chip. It is provided in
The biosensor cartridge is characterized in that the elastic body has an internal space in which an internal pressure can be varied, and is configured to expand in volume as the internal pressure in the internal space increases.   The puncture interlocking means which operates corresponding to the puncture operation of the puncture device is provided, and the internal pressure fluctuation of the internal space is configured to be performed by the puncture interlocking means. Biosensor cartridge.   The biosensor cartridge according to claim 1 or 2, wherein the internal space is formed in an annular shape surrounding a space necessary for sampling.   The biosensor cartridge according to any one of claims 1 to 3, wherein the puncture interlocking means includes a pressure sensor that senses an impact of a puncture operation of the puncture device.   The biosensor cartridge according to any one of claims 1 to 5, further comprising a drive mechanism for puncturing the subject with the puncture device.   The biosensor cartridge according to claim 5, wherein the puncture interlocking unit is configured to interlock with the drive mechanism.   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 is fixed with the double-sided tape, It is characterized by the above-mentioned. The biosensor cartridge according to any one of the above.   Using the biosensor cartridge according to any one of claims 1 to 8, the elastic body is pressed against the specimen and punctured, and then the elastic body is expanded by an increase in internal pressure thereof, and the puncture device A method for using a biosensor cartridge, which comprises extracting a sample from a subject and collecting a sample.   A biosensor comprising: the biosensor cartridge according to any one of claims 1 to 8; 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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