US20110070633A1 - Analytical tool, analytical tool pack, cartridge including plurality of packs, method of making analytical tool pack, analyzer, and mechanism for taking out object - Google Patents

Abstract

The present invention relates to an analytical tool pack (1) including an analytical tool (13) accommodated in one or between a plurality of sealing sheets (12a,12b). The analytical tool pack (1) includes a stopper portion (146) for holding the analytical tool (13) with the analytical tool (13) caused to project from the sealing sheets (12a,12b). Preferably, the analytical tool pack (1) further comprises a base film (14) bonded to the sealing sheets (12a,12b). For example, the stopper portion (146) comprises the bonded portion of the sealing sheets (12a,12b) and the base film (14). The present invention further relates to an analyzer which uses the analytical tool pack (1). The analyzer comprises an opening mechanism for making a cut (15) in the analytical tool pack (1), and a pushing mechanism for moving the analytical tool (13) relative to the sealing sheets (12a,12b) to cause the analytical tool (13) to project through the cut (15).

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application is a Division of U.S. Ser. No. 10/515,713 filed Nov. 23, 2004, which is a U.S. National Stage of PCT/JP03/06240, filed May 19, 2003, which applications are incorporated herein by reference.
TECHNICAL FIELD
• The present invention mainly relates to a technique for analyzing a particular component in a sample liquid. It also relates to a technique for taking out an object from an object-containing pack such as an analytical tool pack.
BACKGROUND ART
• For diabetics, it is preferable to regularly measure his or her own glucose level in blood and take appropriate measures such as medicine administration in accordance with the measurements. JP-A-H08-262026 and JP-A-2001-33418, for example, disclose devices for measuring a blood glucose level.
• As shown inFIG. 45, in a first device disclosed in JP-A-H08-262026, when anoperation portion91 provided on ahousing90 is operated, a sensor S partially projects through anopening90aformed at the front end of thehousing90. In the first device, when the blood of the user is applied to a predetermined portion of the sensor S, the measurement circuit (not shown) in thehousing90 computes the glucose level in blood, and the measurement result is displayed on adisplay92.
• As shown inFIG. 46, in the first device, the sensor S is accommodated in thehousing90 as a package (cartridge)95. Thepackage95 includes abase member95aformed with a plurality of radially extendingrecesses96, and afilm95bbonded to the base member. Each of therecess96 serves to accommodate a sensor S.
• As shown inFIGS. 47A and 47B, when theoperation portion91 is operated to take out the sensor S, ablade97abreaks through part of thefilm95bof thepackage95 and then pushes the rear end of the sensor S toward the outer circumference of thepackage95. As a result, the sensor S breaks through part of thefilm95band is pushed to the opening90aof thehousing90.
• With such a structure, by setting thepackage95 in thehousing90, measurement of the glucose level in blood can be performed a plurality of times by successively using the plurality of sensors S.
• In the first device, when the sensor S is taken out from thepackage95, the sensor S itself breaks through thefilm95b. Therefore, the front end of the sensor S needs to be made sharp. However, since the user may touch the front end of the sensor S, the sharp front end may cause the user to fear and hence is not preferable. Moreover, the sensor S may not break thefilm95beasily, so that taking out of the sensor S by breaking thefilm95bby the sensor S itself is sometimes difficult.
• In a second device disclosed in JP-A-2001-33418, a film member accommodating a sensor is placed in a device. The sensor is taken out by breaking the film and used for measuring a blood glucose level, for example.
• In the second device, the sensor is taken out from the film member, and the measurement is performed. Therefore, the number of parts which need be disposed of after the measurement is large. That is, two parts, i.e. the empty film member and the sensor need be disposed of. Moreover, since the timing at which the film becomes unnecessary does not coincide with the timing at which the sensor becomes unnecessary, the two parts need be disposed of separately, which is inconvenient.
DISCLOSURE OF THE INVENTION
• A first object of the present invention is to make it possible to properly take out a stored object such as a sensor without making sharp the front end of the stored object. A second object of the present invention is to reduce the burden of disposing of the used parts after the analysis.
• According to a first aspect of the present invention, there is provided an analytical tool pack comprising a wrapping member made of a sealing sheet, and an analytical tool accommodated in the wrapping member. The analytical tool pack further comprises a stopper portion for holding the analytical tool with the analytical tool caused to project from the wrapping member.
• The sealing sheet may comprise a pair of sheet elements or a single sheet. When the sealing sheet comprises a pair of sheet elements, the wrapping member is formed by directly or indirectly bonding the paired sheet elements to each other at the peripheries thereof. When the sealing sheet comprises a single sheet, the wrapping member may be formed by folding the sheet.
• Preferably, the wrapping member further comprises a base film bonded to the sealing sheet. For example, in this case, the stopper portion comprises the bonded portion of the sealing sheet and the base film.
• Preferably, the analytical tool includes an engagement portion for engaging with the stopper portion.
• Preferably, at least one of the sealing sheet and the base film retains desiccant. The desiccant may be contained in the sealing sheet and the base film or applied to the surfaces thereof. Alternatively, the desiccant may be held by the base film or the analytical tool.
• Preferably, the analytical tool is caused to project through a cut formed in the sealing sheet by using a cutter, and the base film includes a through-hole for allowing the insertion of the cutter.
• Preferably, the analytical tool includes an end which is caused to project through a cut formed in the sealing sheet by using a cutter, and the end is entirely rounded.
• Preferably, the analytical tool is moved relative to the wrapping member by using a pushing member, the base film includes a through-hole for allowing the movement of the pushing member, and the analytical tool further includes an engagement portion for engaging the pushing member.
• The through-hole of the base member may have an outline which is in the form of a closed loop or an outline which is partially cut away (i.e., part of the through-hole is open to a side of the base film).
• Preferably, the analytical tool includes a substrate, a plurality of electrodes formed on the substrate, and a plurality of holes each for partially exposing a respective one of the electrodes selectively. The electrodes may be continuously exposed.
• Preferably, the analytical tool pack of the present invention further comprises an information providing portion for outputting information relating to the analytical tool. For example, the information providing portion is capable of outputting information by the combination of conduction/non-conduction between a plurality of pairs of conductors, or by correlation with a resistance between conductors, or by correlation with locations where a projection and a recess are formed.
• For example, the analytical tool pack in use is loaded in an accommodation portion of an analyzer. Preferably, in this case, the analytical tool pack further comprises a pack orientation checker for preventing improper loading of the analytical tool into the accommodation portion. Preferably, the analytical tool caused to project from the wrapping member can be restored in the wrapping member for accommodation again.
• According to a second aspect of the present invention, there is provided an analytical tool pack comprising a wrapping member, and an analytical tool accommodated in the wrapping member, the analytical tool pack further comprising an information providing portion for outputting information relating to the analytical tool.
• For example, the information providing portion is capable of outputting information by the combination of conduction/non-conduction between a plurality of pairs of conductors, or by correlation with a resistance between conductors, or by correlation with locations where a projection and a recess are formed. Preferably, the information providing portion is provided at an obverse surface of the wrapping member.
• According to a third aspect of the present invention, there is provided an analytical tool accommodated in a wrapping member for providing an analytical tool pack and caused to project from the wrapping member in use, the analytical tool pack including a stopper portion for holding the analytical tool. The analytical tool includes an engagement portion for engaging with the stopper portion.
• According to a fourth aspect of the present invention, there is provided analytical tool accommodated in a wrapping member for providing an analytical tool pack and caused to project from the wrapping member in use, the analytical tool pack being capable of moving the analytical tool relative to the wrapping member by using a pushing member. The analytical tool includes an engagement portion for engaging with the pushing member.
• According to a fifth aspect of the present invention, there is provided an analytical tool accommodated in a wrapping member for providing an analytical tool pack and including an end which is caused to project from the wrapping member in use of the analytical tool, and the end is entirely rounded.
• According to a sixth aspect of the present invention, there is provided a cartridge including a container accommodating a plurality of analytical tool packs, each of the analytical tool packs including a wrapping member, and an analytical tool accommodated in the wrapping member. The container is formed with a through-hole communicating with the inside of the container and utilized for pushing out the analytical tool pack accommodated in the container.
• Preferably, the plurality of analytical tool packs are bundled in the container. For example, the analytical tool packs are bundled together by applying an adhesive element on a surface of each tool pack and stacking the packs for bonding together, by maintaining the stacked state of tool packs by using a member in the form of a strip, or connecting side surfaces of the stacked analytical tool packs by using an adhesive sheet.
• According to a seventh aspect of the present invention, there is provided a method of making an analytical tool pack comprising the steps of placing an analytical tool on a punch film or a sealing film, and bonding the sealing film to the punch film. The analytical tool is kept at an appropriate position relative to the punch film at least for a time period from when the placing step is completed and till when the bonding step is started.
• For example, the position keeping is performed by using a suction unit.
• According to an eighth aspect of the present invention, there is provided a method of making an analytical tool pack comprising fixing an analytical tool to a sealing film or a punch film. The fixing step is performed simultaneously with respect to a plurality of analytical tools by using a plurality of pressing heads, and the pressing heads are capable of setting respective heights individually.
• According to a ninth aspect of the present invention, there is provided an analyzer for analyzing a sample by using an analytical tool pack including a wrapping member and an analytical tool accommodated in the wrapping member, the analysis being performed with the analytical tool caused to project from the wrapping member. The analyzer comprises an opening mechanism for making a cut in the wrapping member, and a pushing mechanism for moving the analytical tool relative to the wrapping member to cause the analytical tool to project through the cut.
• Preferably, the analyzer of the present invention obtains output relating to analysis results from the analytical tool, with the analytical tool caused to project from the wrapping member.
• For example, the pushing mechanism comprises a first and a second members which are movable relative to each other in a first direction, and a pushing member which is movable in a second direction crossing the first direction in accordance with the relative movement between the first and the second members, the pushing member serving to move the analytical tool relative to the wrapping member.
• For example, the pushing member is pivotally fixed to the first member while being connected to the second member for relative movement to the second member. Preferably, in this case, the second member is provided with a guide for moving a portion connected to the pushing member in the second direction. Preferably, the pushing member comprises a blade.
• For example, the pushing mechanism further comprises a holder for moving the wrapping member together with the first member or the second member. Preferably, in this case, the pushing mechanism further comprises a releaser for releasing the holding of the analytical tool by the holder.
• For example, the releaser increases the distance between the first member and the second member in the second direction when a particular positional relationship is established between the first member and the second member.
• Preferably, the analyzer of the present invention further comprises a restorer for restoring the analytical tool projected from the wrapping member into the wrapping member for accommodation again.
• Preferably, the restorer is provided by the pushing member.
• In the analyzer of the present invention, the second member performs reciprocating movement between a first predetermined position and a second predetermined position relative to the first member twice in a single sample analysis operation. In this case, the pushing member engages and moves the analytical tool to cause the analytical tool to project from the wrapping member when the second member moves from the first position toward the second position in the first reciprocating movement. On the other hand, when the pushing member engages and moves the analytical tool to restore the analytical tool into the wrapping member when the second member moves from the second position toward the first position in the second reciprocating movement.
• In this case, it is preferable that the second member is provided with a cam groove for controlling the operation of the pushing member. For example, the cam groove has a configuration which makes the pushing member operate differently during the first reciprocating movement and during the second reciprocating movement.
• As the analytical tool pack, use may be made of one in which the wrapping member comprises a sealing sheet, and a base film formed with a through-hole and bonded to the sealing sheet. In this case, the opening mechanism includes a cutter for making a cut in the wrapping member, and the cutter and the pushing member move through the through-hole.
• For example, the opening mechanism includes an operation button, and a cutter which moves together with the operation button.
• For example, the analyzer of the present invention may further comprise an accommodation portion into which the analytical tool pack is to be loaded. Preferably, in this case, the accommodation portion includes a pack orientation checker for preventing improper loading of the analytical tool pack into the accommodation portion.
• For example, the analyzer of the present invention comprises a device body including an accommodation portion for accommodating a plurality of analytical tool packs, and a lid connected to the device body. The analytical tool packs are accommodated while being pressed against each other by a pressing member. Preferably, in this case, the lid is connected to the pressing member to release the pressing of the analytical tool packs in opening the accommodation portion.
• According to a tenth aspect of the present invention, there is provided an object taking-out mechanism for taking out an object from a pack in which the object is accommodated in a wrapping member. The mechanism comprises an opening mechanism for making a cut in the wrapping member, and a pushing mechanism for pushing out the object through the cut.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is an entire perspective view showing an analyzer according to a first embodiment of the present invention.
• FIG. 2 is a perspective view showing the analyzer ofFIG. 1 in the state in which the lid is opened.
• FIG. 3 is a sectional view showing a principal portion of the analyzer ofFIG. 1.
• FIG. 4A is a sectional view of the analyzer shown inFIG. 1, whereasFIG. 4B is a sectional view of the state in which the lid is opened in the analyzer.
• FIG. 5A is a sectional view taken along lines Z1-Z1 inFIG. 4A, whereasFIG. 5B is a sectional view corresponding toFIG. 5A for showing another example of sensor pack.
• FIG. 6 is an exploded perspective view of a sensor cartridge.
• FIG. 7 is a sectional view of a sensor cartridge.
• FIG. 8A-8C each is a perspective view for showing a manner of bundling of a plurality of sensor packs.
• FIG. 9 is an entire perspective view of a sensor pack.
• FIG. 10A is a sectional view taken along lines Z2-Z2 inFIG. 9, whereasFIG. 10B is a sectional view taken along lines Z3-Z3 inFIG. 9.
• FIGS. 11A and 11B are perspective views for describing the operation for forming a cut in the sensor pack.
• FIGS. 12A and 12B are perspective views for describing the operation for projecting a biosensor from the sensor pack.
• FIG. 13 is an exploded perspective view of a sensor pack.
• FIG. 14A-14H each is a schematic view for describing the manner of recognizing the information relating to the biosensor by utilizing the information providing portion.
• FIGS. 15A and 15B each is a schematic view for describing another example of information providing portion.
• FIG. 16 is an entire perspective view of a biosensor.
• FIG. 17 is an exploded perspective view of a biosensor.
• FIG. 18A is a sectional view taken along lines Z4-Z4 inFIG. 16, whereasFIG. 18B is a sectional view taken along lines Z5-Z5 inFIG. 16.
• FIG. 19 is a schematic view showing a manufacturing apparatus to describe a method of manufacturing a sensor pack.
• FIGS. 20A and 20B each is a perspective view showing a principal portion to describe a method of manufacturing a sensor pack.
• FIG. 21 is a sectional view taken along lines Z6-Z6 inFIG. 19.
• FIGS. 22A and 22B each is a perspective view showing a principal portion to describe a method of manufacturing a sensor pack.
• FIG. 23 is a sectional view taken along lines Z7-Z7 inFIG. 19.
• FIG. 24 is an entire perspective view of a measurement mechanism.
• FIG. 25 is a sectional view taken along lines Z8-Z8 inFIG. 24.
• FIG. 26 is a sectional view taken along lines Z9-Z9 inFIG. 25.
• FIG. 27 is a front view of a slide block.
• FIGS. 28A and 28B each is a sectional view of a principal portion to describe means for holding a sensor pack in the measurement mechanism.
• FIG. 29A-29C are sectional views showing a principal portion to describe the movement of a movable cutter.
• FIGS. 30A and 30B are sectional views showing a principal portion to describe the operation for projecting a biosensor from a sensor pack.
• FIG. 31 is a sectional view showing a principal portion of a measurement mechanism.
• FIG. 32 is a sectional view showing a principal portion to describe the operation for discharging a sensor pack from the measurement mechanism.
• FIG. 33 is a sectional view showing a slide guide of a measurement mechanism according to a second embodiment of the present invention.
• FIG. 34 is a sectional view taken along lines Z10-Z10 inFIG. 33.
• FIG. 35 is a sectional view taken along lines Z11-Z11 inFIG. 33.
• FIG. 36 is an entire perspective view of a biosensor.
• FIG. 37A is a sectional view showing a measurement mechanism in feeding a biosensor, whereasFIG. 37B is an entire perspective view showing a biosensor which is being fed.
• FIG. 38A is a sectional view showing a measurement mechanism in feeding a biosensor, whereasFIG. 38B is an entire perspective view showing a biosensor which is being fed.
• FIG. 39A is a sectional view showing a measurement mechanism in which the blade is escaping, whereasFIG. 39B is an entire perspective view showing a biosensor in the escaping movement.
• FIG. 40A is a sectional view showing a measurement mechanism in which the biosensor is being returned, whereasFIG. 40B is an entire perspective view showing the biosensor in the returning movement.
• FIG. 41 is an entire perspective view showing another example of biosensor which can be used in the second embodiment.
• FIG. 42 is an exploded perspective view showing another example of sensor pack.
• FIGS. 43A and 43B are an exploded perspective view and an entire perspective view, respectively, for describing another example of sensor pack.
• FIG. 44 is an entire perspective view showing another example of biosensor.
• FIG. 45 is a perspective view showing the appearance of an example of prior art measurement device.
• FIG. 46 is a perspective view showing an example of prior art cartridge and film for covering a sensor.
• FIGS. 47A and 47B show the operation of a prior art measurement device.
BEST MODE FOR CARRYING OUT THE INVENTION
• Preferred embodiments of the present invention will be described below with reference to the accompanying drawings.
• A sensor pack according to the present invention encloses a biosensor and is used for analyzing a sample liquid such as blood supplied to the biosensor, specifically, for measuring e.g. the glucose level in blood. In use, the sensor pack is set to an analyzer X shown inFIGS. 1 and 2.
• The analyzer X comprises adevice body2 formed with anaccommodation portion20 for accommodating asensor pack1, and comprises alid3 which is attached to thedevice body2 in an openable and closeable manner. Thelid3 is provided with adisplay30 and awindow31. Thedisplay30, serving to show measurement results, comprises an LCD, for example. Thewindow31 is used for checking the number of remaining sensor packs1 in theaccommodation portion20. Thewindow31 may be formed by covering anopening32 provided in thelid3 by atransparent member33.
• As shown inFIG. 3, in addition to theaccommodation portion20, thedevice body2 includes anopening mechanism4, ameasurement mechanism5, apassage21 extending from theaccommodation portion20 to themeasurement mechanism5 through a wait position (stop position at which theopening mechanism4 performs the opening operation), and afeeder22 for moving thesensor pack1 within thepassage21.
• As shown inFIGS. 2 through 4, theaccommodation portion20 serves to accommodate a plurality of sensor packs1 as stacked. As shown inFIG. 5A, theaccommodation portion20 is formed with a taperedportion23 for preventing improper loading of the sensor packs (loading of the sensor packs1 upside down or inside out). Though not clearly shown in the figure, the taperedportion23 extends in a direction perpendicular to the sheet surface. On the other hand, eachsensor pack1 is formed with atapered surface10 provided by chamfering one of the corners. Therefore, thesensor pack1 can be loaded properly in theaccommodation portion20 when the taperedsurface10 of thesensor pack1 is aligned with respect to the taperedportion23 of theaccommodation portion20. Thesensor pack1 cannot be loaded properly without such alignment. Thus, improper loading of thesensor pack1 is prevented. The means for preventing the improper loading of thesensor pack1 is not limited to the example shown inFIG. 5. For example, as shown in FIG.5B′, theaccommodation portion20 may be formed with aprojection23′ while thesensor pack1 is formed with arecess10, or another arrangement may be employed.
• Theaccommodation portion20 further accommodates a pushingmember24. The pushingmember24 is fixed to thedevice body2 via a resilient member25 (illustrated as a coil spring inFIGS. 3 and 4). By the resilient force of theresilient member25, thesensor pack1 is pushed in the direction indicated by the arrow A in the figure. Thesensor pack1, thus held in the pushed state, is then held at the wait position and finally transferred to themeasurement mechanism5 by the movement of thefeeder22 . Preferably, thefeeder22 is moved automatically by a motor, for example. Alternatively, thedevice body2 or thelid3 may be provided with an operation knob projecting therefrom and movable together with thefeeder22, so that thefeeder22 is moved manually by moving the operation knob.
• As shown inFIGS. 4A and 4B, the pushingmember24 is connected to thelid3 via arod26. Therod26 has a first end connected to the pushingmember24 for pivotal movement and a second end connected to thelid3 via anelongated hole34 formed in thelid3. As shown inFIG. 4A, theelongated hole34 extends in the direction indicated by the arrows AB in the state in which thelid3 is closed. Therefore, when thelid3 is closed, the second end of therod26 can move smoothly within theelongated hole34. Accordingly, following the movement of the pushingmember24, therod26 can move in the direction indicated by the arrows AB in the figure, whereby the pushingmember24 can maintain the state for properly pushing thesensor pack1.
• As shown inFIG. 4B, in opening or closing thelid3, the direction in which theelongated hole34 extends becomes non-parallel to the direction indicated by the arrows AB. In this state, the second end of therod26 cannot move smoothly within theelongated hole34. Therefore, when thelid3 is opened, thepush member24, following the movement of thelid3, moves in the direction indicated by the arrow B, whereby a space is defined between thepush member24 and thesensor pack1. The space is utilized for additionally loading asensor pack1 into thedevice body2.
• As shown inFIGS. 6 and 7, a plurality of sensor packs1 for additional loading are preferably stored as accommodated in acontainer6. The illustratedcontainer6 includes acontainer body60 for accommodating a plurality of sensor packs1, and alid61 attached to thecontainer body60 and provided with ahook62. Thecontainer body60 is provided with aprojection63 and anopening64. Theprojection63 serves to engage thehook62. By this engagement, the state in which thelid61 is closed is maintained properly. As better shown inFIG. 7, the sensor packs1 accommodated in thecontainer body60 can be pushed up by inserting e.g. a finger into theopening64. Thus, a required number of sensor packs1 can be taken out easily.
• Preferably, in thecontainer body60, a plurality of sensor packs1 are stored as stacked and bundled together. Specifically, the bundle of sensor packs1 is made by using anadhesive element11asuch as a double-sided adhesive tape or an adhesive as shown inFIG. 8A, by using astrip11bas shown inFIG. 8B or by using afilm11chaving an adhesive surface as shown inFIG. 8C. The methods shown inFIGS. 8A-8C are merely examples, and the sensor packs1 may be bundled by methods other than those shown in the figures.
• As shown inFIGS. 9 and 10, thesensor pack1 includes a pair of sealingsheets12a,12b, and abiosensor13 and abase film14 which are enclosed between the sealing sheets. In using thesensor pack1, aslit15 is formed at the front end as shown inFIGS. 11, and thebiosensor13 is caused to project from theslit15, as shown inFIG. 12B.
• For example, each of the sealingsheets12a,12bmay be a laminate formed by disposing an aluminum foil between resin sheets . As shown inFIG. 13, the sealingsheet12ahas an obverse surface provided with aninformation providing portion16 for outputting information relating to thebiosensor13. Examples of the information relating to thebiosensor13 may include data (correction information) which enables computation based on the sensitivity of thebiosensor13, or individual information on the biosensor13 (the date of production, the expiry date, the manufacturer, the place of production (e.g. country or factory), and the identification information of the lot (lot number) in which thebiosensor13 is included. In this embodiment, the formation pattern of theinformation providing portion16 is selected depending on the content of the information to be outputted. For example, as shown inFIGS. 14A-14H, theinformation providing portion16 includes acommon electrode16ain the form of a strip and threeindividual electrodes16b. With respect to each of theindividual electrodes16b, whether or not theindividual electrode16bis connected to thecommon electrode16avia aconductor16cis selected, whereby an appropriate pattern (information) can be selected from eight patterns. The number of the individual electrodes and the number of patterns are not limited to those illustrated in the figures. Theinformation providing portion16 can be provided with an intended pattern by screen printing or vapor deposition, for example. The recognition manner of the information provided by theinformaticn providing portion16 will be described later.
• The information providing portion may have another structure as shown inFIGS. 15A and 15B. The information providing portion16A shown inFIG. 15A includes a pair ofpads16d,16econnected to each other via aresistor16f. In the information providing portion16A, the resistance of theresistor16fis set depending on the content of the information to be outputted. The resistance of theresistor16fis adjusted by selecting the thickness, width, length or material of theresistor16f. Theinformation providing portion16B shown inFIG. 15B can output information of an intended content by selecting whether or not acutout16gis formed at a predetermined portion. Obviously, the information providing portion may have a structure different from those shown inFIGS. 13,15A and15B.
• As shown inFIGS. 11 through 13, thebase film14 has a T-shaped through-hole140. The through-hole140 comprises an unsealinggroove141 and aguide groove142 connected to each other. As better shown inFIG. 11, the unsealinggroove141 is utilized for forming theslit15 in the front end of thesensor pack1. Theslit15 is formed by breaking thesensor pack1 with ablade41, and the unsealinggroove141 is provided to help the penetrating movement of theblade41. Theguide groove142 is utilized for causing thebiosensor13 to project from thesensor pack1. Specifically, thebiosensor13 is caused to project from thesensor pack1 by moving thebiosensor13 by using ablade553, and theguide groove142 guides the movement of theblade553. The configuration of the through-hole140 is not limited to the illustrated one. For example, part of the through-hole may be open to a side of the base film.
• Thebase film14 having the above configuration is bonded to one of the sealingsheets12aat the periphery thereof and more specifically at abonding region143 which is cross-hatched inFIG. 13. Though not illustrated in the figure, thebase film14 is bonded also to the other one of the sealingsheets12bin a similar manner.
• Thebonding region143 includes a pair ofextensions144. With the provision of theextensions144, aspace145 accommodating thebiosensor13 is defined between the sealingsheet12aand thebase film14. As shown inFIGS. 9,10A and10B, the width of thespace145 is narrow at a portion corresponding to theextensions144. The narrow portion serves as astopper portion146 for stopping the movement of thebiosensor13, as will be described later.
• The provision of thestopper portion146 eliminates the need for providing a stopper mechanism for stopping the movement of thebiosensor13 in the analyzer X, whereby the analyzer X is advantageous in terms of the manufacturing cost. Further, the handling of thebiosensor13 for measurement or disposal, for example, can be performed while keeping thebiosensor13 integral with the pack. Moreover, thebiosensor13 after use can be easily accommodated again just by pushing thebiosensor13 into thesensor pack1.
• Since thespace145 accommodates thebiosensor13, it is preferable to keep the humidity in thespace145 low. Thebase film14 can be made of a resin material such as polyethylene, polyethylene terephthalate or polyamide. Therefore, desiccant powder such as silica or molecular sieve may be contained in thebase film14 to provide dehumidifying function. In this case, the content of the desiccant powder is preferably 1 to 60% by weight, and more preferably 20 to 40% by weight relative to the total weight of thebase film14. The desiccant powder may be contained or applied to the sealingsheet12a, or thebiosensor13 itself may have dehumidifying function.
• The containing or the like of the desiccant powder eliminates the need for loading a desiccant in thespace145 and provides an advantage in terms of the manufacturing cost. Since dropping of the desiccant from thespace145 does not occur in opening thesensor pack1, troubles due to the dropped desiccant can be avoided.
• As shown inFIGS. 13,16 and17, thebiosensor13 has a rounded front end, and a rear end provided with acutout130 and astopper portion131. As better shown inFIGS. 12A and 12B, thecutout130 serves to allow the penetration of theblade553 through thesensor pack1 and the pushing of thebiosensor13 by theblade553. Thestopper portion131 of thebiosensor13 engages thestopper portion146 of thesensor pack1 when thebiosensor1 has moved to stop the movement of thebiosensor13. As shown inFIGS. 16 and 17, thebiosensor13 comprises asubstrate132, and aspacer18 and acover19 which are stacked on the substrate. As shown inFIG. 18A, aflow path133 is defined on thesubstrate132.
• As shown inFIGS. 17 and 18A, thespacer18 is formed with anarrow slit180 having an open end, and theslit180 defines theflow path133. Thecover19 is formed with ahole190 communicating with theslit180 so that gas in theflow path133 can be discharged to the outside through thehole190. Therefore, when a sample liquid is supplied through the front open end (sample introduction port)181 of theslit180, the sample liquid travels through theflow path133 toward thehole190 by capillary action.
• As shown inFIGS. 16 and 17, on thesubstrate132 are provided anoperative electrode134, acounterpart electrode135, a pair ofdetection electrodes136, and areagent layer137 continuously bridging the electrodes134-136. As shown inFIG. 18B, each of the electrodes134-136 is partially exposed via through-holes138 penetrating through both of thespacer18 and thecover19. With this arrangement, probes591-594, which will be described later, can be brought into contact with the electrodes134-136 through the through-holes138, whereby the application of a voltage to thereagent layer137 and the measurement of the responsive current when the voltage is applied can be performed.
• Thereagent layer137, which may be solid, is prepared by dispersing a relatively small amount of oxidoreductase in a relatively large amount of mediator (electron carrier), for example.
• As the electron carrier, use may be made of iron complex or Ru complex, for example. In this case, examples of usable iron complex include potassium ferricyanide, whereas examples of usable Ru complex include one having NH₃as a ligand.
• The selection of the oxidoreductase depends on the kind of the particular component as the measurement target substance. Examples of particular component include glucose, cholesterol and lactic acid. Examples of oxidoreductase for such particular components include glucose dehydrogenase, glucose oxidase, hexokinase, cholesterol dehydrogenase, cholesterol oxidase, lactic acid dehydrogenase and lactic acid oxidase.
• For example, the above-describedsensor pack1 can be manufactured by the method which will be described below with reference toFIGS. 19-23. Herein, it is assumed that thebiosensor13 to be accommodated in thesensor pack1 is manufactured in advance, and the description of the manufacturing method is omitted.
• As shown inFIG. 19, thesensor pack1 is formed by placing thebiosensor13 at an appropriate position on apunch film70, bonding sealingfilms71 and72, and then cutting the bonded member.
• Specifically, as shown inFIG. 20A, a plurality of basefilm forming regions700 are defined on thepunch film70. Each of the basefilm forming regions700 is formed with a generally T-shaped throughhole701. Each of the basefilm forming regions700 is supported relative to aflame portion702 and/or an adjacent basefilm forming region700 via asupport bar703. As shown inFIG. 19, thepunch film70 is transferred by abelt conveyor8. Thebelt8A of thebelt conveyor8 is made porous or in the form of a mesh to have excellent breathability.
• As shown inFIGS. 19 and 21, the placing of thebiosensor13 on thepunch film70 is performed automatically by using avacuum collet80, for example. As will be understood from e.g.FIGS. 20B and 21, the placing operation is performed individually with respect to each of the basefilm forming region700. Alternatively, a plurality ofbiosensors13 may be placed simultaneously. Thebiosensors13 thus placed are kept at respective positions by a plurality ofsuction nozzles81 provided below thepunch film70. Specifically, since the through-hole701 is formed in each of the basefilm forming regions700 and thebelt8A has excellent breathability, when each of thesuction nozzles81 is placed directly below thebiosensor13 to suck the biosensor, thebiosensor13 is pulled toward thesuction nozzle81 while being kept in close contact with the basefilm forming region700.
• The suction nozzles81 are movable together with thepunch film70 in the direction indicated by arrows CD inFIG. 19. Therefore, each of thebiosensors13 is transferred together with thepunch film70 while being positioned at the basefilm forming region700. The positioned state is maintained until the subsequent step for bonding the sealingfilm71 is completed.
• The bonding of the sealingfilm71 is performed by laying the sealingfilm71 on thepunch film70 as an overlying layer as shown inFIG. 22A, and then applying thermal energy by using a plurality of (three in the figure) fusingstamps82 as shown inFIGS. 19 and 23. The sealingfilm71 is supplied from theroll78. The sealingfilm71 is formed, in advance, with information providing portions (indicated byreference sign16 inFIG. 13) at portions corresponding to the basefilm forming portions700. The information providing portions may be formed after the sealingfilm71 is bonded.
• The fusingstamps82, which are spaced in the widthwise direction of thebelt conveyor8, fuse the sealingfilm71 to a plurality ofbase forming regions700 simultaneously. Each of the fusingstamps82 has an end surface having a configuration corresponding to the hatchedportion85 inFIG. 22B so that thermal energy can be applied selectively to the peripheral portion of each of the basefilm forming regions700. Each of the fusingstamps82 is individually movable up and down by the driving force of a non-illustrated pump, for example. Therefore, even when the regions (fusion portions) to which the fusingstamps82 are to apply thermal energy differ from each other in height, such a problem can be properly addressed, and proper bonding can be achieved. Specifically, as a result of the individual driving of the fusingstamps82, each of the fusingstamps82 can be located at its own height position. Therefore, even when the fusion portions have height variation, each of thefusion stamps82 can be located at a position corresponding to the higher fusion portion. Thus, thermal energy can be properly applied to each fusion portion, whereby thermal fusing can be properly performed.
• After the thermal fusing, thebiosensor13 is retained at an appropriate position between thepunch film70 and the sealingfilm71. The suction of thebiosensor13 by using thesuction nozzle81 is released.
• Subsequently, after the sealingfilm71 is cut, the sealingfilm71 and thepunch film70 are turned over and transferred onto abelt conveyor8′ for bonding a sealing film72 (SeeFIG. 19). With the sealingfilm72 placed on thepunch film70 as an overlying layer, the sealingfilm72 is bonded. As a result, the biosensor is hermetically sealed between the paired sealingfilms71 and72. The bonding of the sealingfilm72 is performed by using fusingstamps82′ which are similar to those described above. Thereafter, cutting is performed at a portion corresponding to each of thefilm forming regions700, whereby individual sensor packs1 as shown inFIGS. 9 and 13 are obtained.
• Each of the sealingfilms71,72 is not limited to one in the form of a hoop, and use may be made of one which has been cut to a size corresponding to the size of thepunch film70. The bonding of the sealingfilm72 may be performed by placing the sealingfilm72 on thebelt conveyor8′ in advance, placing the sealingfilm71 and thepunch film70 on the sealingfilm72 without turning over, and then performing fusing.
• Theopening mechanism4 shown inFIG. 3 serves to open thesensor pack1 held at the wait position. Theblade41 and anoperation button40 are included in theopening mechanism4. Theoperation button40 is accommodated in aspace27 defined in thedevice body2 while being biased toward the front side of the device body2 (in the direction indicated by the arrow A in the figure) by a resilient member42 (illustrated as a coil spring inFIG. 3). Theblade41 is integrally formed on theoperation button40 to move together with theoperation button40. Therefore, when a pushing force to push theoperation button40 toward the deeper side of the device body (in the direction indicated by the arrow B in the figure) is applied to the button, theblade41 moves together with theoperation button40 in the arrow B direction to penetrate through the front end of thesensor pack1, as shown inFIG. 11A. Accompanying the pushing of theoperation button40, a power source for driving themeasurement mechanism5, for example, may be turned on or thefeeder22 shown inFIG. 3 may be moved to automatically feed asensor pack1 toward themeasurement mechanism5. When the force exerted to theoperation button40 is released, theoperation button40 and theblade41 return to their original positions. Thus, theslit15 as shown inFIG. 11B is formed at the front end of thesensor pack1, whereby thesensor pack1 is opened. Although theblade91 moves integrally with theoperation button40 in the illustrated example, the blade may be so arranged as to move following the movement of the operation button. In this case, the following movement may be realized by a mechanical system or an electrical system.
• At the wait position, information relating to thebiosensor13 is read by utilizing theinformation providing portion16 before thesensor pack1 is opened. Specifically, as will be understood fromFIGS. 14A-14H, thedevice body2 is provided with a singlecommon terminal43 and three individual terminals44. When thesensor pack1 is at the wait position, thecommon terminal43 comes into contact with thecommon electrode16aof thesensor pack1, whereas the tree individual terminals44 come into contact with respectiveindividual electrodes16bof thesensor pack1. The information of theinformation providing portion16 is recognized based on the presence or absence of conduction between each of the individual terminals44 and thecommon terminal43 as well as the combination thereof. As will be understood fromFIGS. 14A-14H, eight kinds of information distinguishable from each other can be recognized in this embodiment. When the information providing portion16A as shown inFIG. 15A is utilized, asingle measurement terminal44A is provided in the device body2 (SeeFIGS. 2 and 3). When theinformation providing portion16B as shown inFIG. 15B is utilized, a plurality ofswitches45 and a plurality ofmovablemembers46 capable of individually opening and closing theswitches45 are provided in the device body. In this case, eachswitch45 is kept open when the relevantmovable member46 is received in acutout16gof thesensor pack1, whereas theswitch45 is closed when themovable member46 is located at a portion which is not formed with acutout16g. The information of theinformation providing portion16B is recognized based on the combination of ON/OF of eachswitch45.
• For example, when thesensor pack1 is provided with information on the lot and the usable period, the device may automatically perform correction so as not to perform the measurement when the usable period of thesensor pack1 is expired. With such an arrangement, when a user additionally loads sensor packs1 into the accommodation portion (SeeFIGS. 2 and 3), the user need not pay attention to the lot and usable period of eachsensor pack1 to be loaded, which is convenient.
• Themeasurement mechanism5 serves to cause thebiosensor13 to project from thesensor pack1 opened and transferred from the wait position and to measure the concentration of a particular component in the sample liquid supplied to thebiosensor13. As shown inFIG. 24, themeasurement mechanism5 includes abase50, and aslider51 slidably connected to the base. Theslider51 is reciprocally movable by known means such as a rack and pinion mechanism by utilizing the driving force of e.g. a motor (not shown).
• As shown inFIGS. 24-26, thebase50 includes abase portion52 andside walls53 extending upward from opposite side edges of thebase portion52. The base50 further includes opposite ends provided with plate frames501,502. Theplate frame501 is formed with anopening503 for introducing thesensor pack1, whereas theplate frame502 is formed with anopening504 for discharging thesensor pack1. The plate frames501,502 support aguide rod505.
• Thebase portion52 has an upper surface formed with twoguide grooves520 and is formed with aspace54 at the center portion thereof, as shown inFIG. 25. Amovable cutter55 is arranged in thespace54, and anelongated hole541 is formed at aside wall540 defining thespace54. Themovable cutter55 comprises ablade553 and a holdingblock552 for holding the blade. Themovable cutter55 has opposite ends one of which is pivotally connected to thebase50 via ashaft portion550. The other end of themovable cutter55 is connected to theelongated hole541 via ashaft portion554, so that the pivoting range of themovable cutter55 is defined by theelongated hole541. Each of theside walls53 has an upper portion formed with anelongated hole530, and anupper surface531 formed with a taperedportion532 at an end thereof.
• Theslider51 includes aslide guide56 and aslider block57. Theslider guide56 and theslider block57 are connected to each other via a resilient member510 (illustrated as a coil spring in the figure) and pins511. Therefore, theslide guide56 and theslider block57 can move together relative to thebase50 and move vertically relative to each other.
• As shown inFIGS. 24-27, theslider block57 is provided with a pair of front hooks570 and a pair of rear hooks571. As better shown inFIG. 27, the front hooks570 and the rear hooks571 serve to hold thesensor pack1 and are so arranged that the distance between thefront hooks570 and the rear hooks571 corresponds to the length of thesensor pack1. Though not clearly shown in the figure, the distance between the paired front hooks570 and the distance between the pairedrear hooks571 are set to be smaller than the width of thesensor pack1 and larger than the width of thebiosensor13.
• Each of the front hooks570 is formed integrally on theslider block57. However, the front hook may be made separately from the slider block. Each of the rear hooks571 is connected to the rear end of theslider block57 via ashaft572. Therear hook571 is pivotally supported by theslider block57 while being biased downward by aresilient member573. The rear end of therear hook571 has a curved surface.
• As noted above, thesensor pack1 is transferred to themeasurement mechanism5 by thefeeder22. Specifically, as shown inFIG. 28A, thesensor pack1 is transferred onto thebase portion52 of the base50 through theopening503 of theplate frame501. When thesensor pack1 is further pushed from this position, thesensor pack1 moves while coming into contact with the curved surface of the rear hooks571, whereby the rear hooks571 are lifted. As shown inFIG. 28B, when thesensor pack1 is moved until the front end of thesenor pack1 engages the front hooks570, the front hooks570 hinder further advancement of thesensor pack1. Since the distance between thefront hooks570 and the rear hooks571 corresponds to the length of thesensor pack1, the rear end of thesensor pack1 engages the rear hooks571, whereby thesensor pack1 is snugly held between thefront hooks570 and the rear hooks571. In this state, thesensor pack1 is movable together with theslider block57, and hence, with theslider51.
• As shown inFIGS. 24-26, theslider guide56 includes anupper frame portion560, andside walls561 extending downward from opposite side edges of theupper frame portion560. Theupper frame portion560 is formed with a through-hole562. Theguide rod505 is inserted in the through-hole562, whereby theupper frame portion560, and hence, theslide guide56 is supported by theguide rod505. With this arrangement, theslide guide56, and hence the entirety of theslider51 is movable along theguide rod505.
• Theside wall561 is formed with acam groove563. Thecam groove563 has opposite ends respectively provided with a first and a secondstraight movement portions564 and565 which differ from each other in height position. Thestraight movement portions564 and565 are connected to each other via an up/downmovement portion566. Thecam groove563 receives theshaft portion554 of themovable cutter55. Therefore, when the position of theshaft portion554 in thecam groove563 is changed by moving theslide guide56, themovable cutter55 pivots, whereby the height position of theblade553 of themovable cutter55 changes.
• Specifically, as shown inFIGS. 28B and 29A, when theslider51 is positioned on the right side in the figure and theshaft portion554 is positioned in the firststraight movement portion564, theblade553 of themovable cutter55 is positioned at the bottom dead center. As shown inFIG. 29B, when theslide guide56 is moved to move theshaft portion554 from the firststraight movement portion564 toward the secondstraight movement portion565 through the up/downmovement portion566, theblade553 of themovable cutter55 moves upward. As shown inFIG. 29C, when theshaft portion554 reaches the secondstraight movement portion565, theblade553 is positioned at the top dead center.
• As shown inFIG. 12A, theblade553 moved upward in the above manner penetrates through thesensor pack1. Theblade553 then engages thecutout130 of thebiosensor13. In this state, when theslider51 is moved relative to the base50 in the direction indicated by the arrow E in the figures (SeeFIGS. 29A-29C), thesensor pack1 moves together with theslider51 in the arrow E direction, because thesensor pack1 is held by the front hooks570 and the rear hooks571, as shown inFIG. 30. During this movement, theshaft portion554 is positioned in the secondstraight movement portion565, so that theblade553 of themovable cutter55 is kept at the top dead center. As a result, the engagement of theblade553 with thebiosensor13 is maintained, so that thebiosensor13 moves relative to the sensor pack1 (relative to the sealingsheets12a,12band thebase film14, to be exact) in the direction indicated by the arrow F.
• As a result, as shown inFIG. 12B, thebiosensor13 projects through theslit15 previously formed in thesensor pack1. Since the distance between the paired front hooks570 is larger than the width of thebiosensor13, thebiosensor13 projects from between the front hooks570. Since the front end of thebiosensor13 is rounded, the projecting operation can be performed smoothly. The movement of thebiosensor13 is stopped when thestopper portion131 of thebiosensor13 engages thestopper portion146 of thesensor pack1. Thus, the plurality of through-holes138, and hence, the electrodes134-136 of thebiosensor13 are exposed to the outside. In this embodiment, the exposed area of each electrode134-136 is made as small as possible by the provision of the through-holes138. Therefore, the electrodes134-136 of thebiosensor13 projecting from the slit are prevented from coming into contact with the nearby portion of theslit15 of the sealingsheet12a, whereby short circuiting between the electrodes134-136 are prevented.
• As shown inFIG. 30B, when theslide guide56 is moved in the arrow F direction in the figure, theshaft portion554 moves from the secondstraight movement portion565 toward the firststraight movement portion564 through the up/downmovement portion566, whereby theblade553 of themovable cutter55 moves downward. At this time, the entirety of thesensor pack1 including thebiosensor13 moves in the arrow F direction, so that thebiosensor13 projects from themeasurement mechanism5, and hence, from anopening29 of thedevice body2 shown inFIGS. 1 and 2. As will be understood fromFIG. 18A, to thebiosensor13 in this state, the sample liquid is supplied through thesample introduction port181 for performing analysis of the sample liquid.
• As shown inFIG. 31, four probes591-594 are fixed to theslider block57. As shown inFIG. 18B, the probes591-594 are so arranged as to come into contact with the electrodes134-136, respectively, through the through-holes138 when thebiosensor13 is in the state shown inFIG. 12B. With this arrangement, a voltage can be applied to thereagent layer137 shown inFIGS. 17 and 18A, and the responsive current can be measured. Based on the responsive current, analysis of the sample (e.g. computation of the concentration of a particular component in the sample liquid) can be performed, or the introduction of the sample liquid into theflow path133 can be detected.
• As shown inFIGS. 24 and 27, the upper end of theslider block57 is formed with a pair offlanges59 projecting widthwise outward of theslider block57. Each of theflanges59 slides on theupper surface531 of thecorresponding side wall53 of the base50 when the slider block57 (slider51) moves relative to thebase50. As noted above, a taperedportion532 is formed at an end of theupper surface531. Therefore, as shown inFIGS. 27 and 32, when theflange59 rides on the tapered portion, the end of the slider block57 (slider51) is lifted relative to thebase50. As a result, the engagement between thefront hooks570 and thesensor pack1 is released, whereby thesensor pack1 together with thebiosensor13 is released from themeasurement mechanism5, or from the opening29 (SeeFIGS. 1 and 2) of thedevice body2. In the analyzer X, the entirety of thebiosensor13 may be accommodated again in thesensor pack1 before the disposal of thesensor pack1. In this case, the user can dispose of the biosensor without touching the biosensor1 (particularly blood), which is preferable from a hygienic point of view.
• As described above, since the front end of the biosensor need not be made sharp, the user does not feel fear and is not hurt by thebiosensor13. Thesensor pack1 after the analysis can be disposed of together with and at the same time as thebiosensor13. Therefore, the number of parts to be disposed of is small, and thesensor pack1 can be disposed of with little trouble.
• Next, a second embodiment of the present invention will be described below with reference toFIGS. 33-40. InFIGS. 33-40, elements which are identical or similar to those of the first embodiment described above are designated by the same reference signs, and the description thereof is omitted below.
• As shown inFIG. 33, theslide guide56C of the measurement mechanism of the analyzer includes aside wall561C formed with anon-penetrating cam groove563C. Thecam grove563C includes an upper groove portion567AC, a lower groove portion567BC, a downwardmovement groove portion568C connecting between the groove portions567AC and567BC, and an upwardmovement groove portion569C.
• The upper groove portion567AC includes a first and a secondstraight movement portions564C and565C which differ from each other in height position, and an up/downmovement portion566C connecting between thestraight movement portions564C and565C. As will be understood fromFIGS. 33-35, the first and the secondstraight movement portions564C,565C and the up/downmovement portion566C have the same depth.
• The lower groove portion567BC extends below the first and the secondstraight movement portions564C,565C and in parallel with the first and the secondstraight movement portions569C,565C. The lower groove portion567BC has a uniform depth which is generally equal to that of the upper groove portion567AC.
• Thedownward movement portion568C connects an end of the upper groove portion567AC and an end of the lower groove portion567BC to each other, and the part of the downward movement portion connected to the end of the lower groove portion567BC is smaller in depth than the lower groove portion567BC, as better shown inFIG. 34.
• As shown inFIG. 33, theupward movement portion569C connects the upper groove portion567AC and the lower groove portion567BC to each other at a position deviated from thedownward movement portion568C in the arrow E direction. As better shown inFIG. 35, the part of theupward movement portion569C connected to the upper groove portion567AC is smaller in depth than the upper groove portion567AC.
• As will be understood from e.g.FIG. 37A, thecam groove563C receives theshaft portion554 of themovable cutter55. Therefore, by moving theslide guide56C, the position of theshaft portion554 in thecam groove563C changes. As a result, themovable cutter55 pivots so that the height position of themovable cutter55 changes. In thecam groove563C having the above configuration, it is preferable that theshaft portion554 is biased toward theside wall561C.
• In this embodiment, abiosensor13C as shown inFIG. 36 is used, for example. The illustratedbiosensor13C is similar in basic structure to the biosensor13 (SeeFIG. 16) used in the first embodiment but differs from thebiosensor13 in structure for engagement with theblade553 of themovable cutter55. Specifically, the portion for engagement with theblade553 comprises a through-hole130C.
• In this embodiment, theslide guide56C is caused to reciprocate twice in the arrow EF direction in the figure in a single sample analysis operation (SeeFIG. 33). Specifically, the first reciprocal movement is performed to cause thebiosensor13 to project from theslit15 of thesensor pack1C similarly to the first embodiment (SeeFIG. 38B), whereas the second reciprocal movement is performed to pull thebiosensor13C into thesensor pack1C to accommodate thebiosensor13C again (SeeFIG. 40B).
• As shown inFIG. 33, the movement route of the shaft portion554 (See e.g.FIG. 37A) of themovable cutter55 in thecam groove563C differs between the first reciprocal movement (for pushing out thebiosensor13C (SeeFIG. 38B)) and the second reciprocal movement (for accommodating thebiosensor13C again (SeeFIG. 40B)). Thus, theblade553 of themovable cutter55 operates differently between the first reciprocal movement and the second reciprocal movement. InFIG. 33, the movement route of theshaft portion554 in the first reciprocal movement is indicated by a single dashed line, whereas the movement route of theshaft portion554 in the second reciprocal movement is indicated by a chain line.
• In the first reciprocal movement, the shaft portion554 (See e.g.FIG. 37A) starts from the point P1 and pass through the points P2-P5 before reaching the point P6.
• Specifically, when theslide guide56C moves in the arrow E direction, theshaft portion554 moves through the firststraight movement portion564C, the up/downmovement portion566C, and the secondstraight movement portion565C, similarly to the first embodiment. It is to be noted that, when theshaft portion554 reaches the point P8, the shaft portion does not enter theupward movement portion569C but moves straight in the arrow F direction to reach the point P4, because the secondstraight movement portion565C is larger in depth than the part of theupward movement portion569C connected to the secondstraight movement portion565C.
• As will be understood fromFIG. 37A, when theshaft portion554 is positioned in the firststraight movement portion564C (between the points P1 and P2), theblade553 of themovable cutter55 is located at a first bottom dead center. When theslide guide56C is moved in the arrow E direction to move theshaft portion554 from the firststraight movement portion564C toward the secondstraight movement portion565C through the up/downmovement portion566C (between the points P2 and P3), theblade553 of themovable cutter55 moves upward. When theshaft portion554 reaches the secondstraight movement portion565C (point P3), theblade553 is positioned at the top dead center.
• As shown inFIG. 37B, theblade553 moved upward in the above manner penetrates through thesensor pack1C and is inserted into the through-hole130C of thebiosensor13C for engagement with the inner surface of the through-hole130C. In this state, when theslider51 is moved relative to the base50 in the direction indicated by the arrow E in the figures, thesensor pack1C moves together with theslider51 in the arrow E direction, as shown inFIGS. 38A and 38B. During this movement, theshaft portion554 is positioned in the secondstraight movement portion565C, so that theblade553 is kept at the top dead center. As a result, as better shown inFIG. 38B, the engagement of theblade553 with the through-hole130C of thebiosensor13C is maintained, so that thebiosensor13 moves relative to the sensor pack1 (relative to the sealingsheets12a,12band thebase film14, to be exact) in the direction indicated by the arrow F. As a result, thebiosensor13C projects from theslit15 of thesensor pack1C.
• With thebiosensor13C projecting from thesensor pack1C, a sample is supplied to thebiosensor13C, whereby the concentration of a particular component in the sample is computed, similarly to the above-described first embodiment.
• Unlike the first embodiment, when theslide guide56C moves in the arrow F direction, theshaft portion554 moves through thedownward movement portion568C (between the points P4 and P5) to move to a lower position and then moves straight through the lower groove portion567BC (between the points P5 and P6) to reach the point P6, as will be understood fromFIG. 33.
• As can be seen fromFIGS. 38A and 39A, when theslide guide56C moves through thedownward movement portion568C (between the points P4 and P5 inFIG. 33) , theblade553 of themovable cutter55 moves downward. When theshaft portion554 reaches the lower groove portion567BC (the point P5 inFIG. 33), theblade553 is positioned at a second bottom dead center.
• By moving theblade553 downward in the above manner, theblade553 is pulled out from thesensor pack1C, as shown inFIGS. 39A and 39B. In this state, when theslide guide56C is moved in the arrow F direction in the figure, theshaft portion541 moves straight through the lower groove portion567BC (between the points P5 and P6 inFIG. 33) while keeping theblade553 at the bottom dead center.
• In the second reciprocal movement, the shaft portion554 (See e.g.FIG. 37A) starts from the point P6 and pass through the points P7, P8 and P2 to reach the point P1, as shown inFIG. 33.
• Specifically, when theslide guide56C moves in the arrow E direction, theshaft portion554 moves straight through the lower groove portion567BC from the point P6 toward the point P7, and then moves through theupward movement portion569C (P7, P8) to reach the point P8. It is to be noted that, when theshaft portion554 reaches the point P7, the shaft portion does not enter thedownward movement portion568C but moves through theupward movement portion569C, because theupward movement portion569C is larger in depth than the part of thedownward movement portion568C connected to the lower groove portion567BC (SeeFIG. 34).
• As will be understood fromFIGS. 33 and 39A, when theshaft portion554 is located in the lower grove portion567BC (between the points P6 and P7), theblade553 of themovable cutter55 is located at the second bottom dead center. When theshaft portion554 moves through theupward movement portion569C (between the points P7 and P8), theblade553 of themovable cutter55 moves upward. When theshaft portion554 reaches the secondstraight movement portion565C (the point P8) , theblade553 is positioned at the top dead center.
• Theblade553 moved upward in the above manner is inserted again into the through-hole130C of thebiosensor13C for engagement with the inner surface of the through-hole130C (SeeFIG. 38B). In this state, when theslider51 is moved relative to the base50 in the direction indicated by the arrow F in the figures, thesensor pack1C moves together with theslider51 in the arrow F direction. During this movement, theshaft portion541 is positioned in the secondstraight movement portion565C, so that theblade553 is kept at the top dead center. As a result, as better shown inFIG. 40B, the engagement of theblade553 with the through-hole130C of thebiosensor13C is maintained, so that thebiosensor13C moves relative to thesensor pack1C (relative to the sealingsheets12a,12band thebase film14, to be exact) in the direction indicated by the arrow E. As a result, thebiosensor13C is accommodated again in thesensor pack1C.
• Similarly to the first embodiment, when theslide guide56C moves in the arrow F direction, theshaft portion554 moves through the secondstraight movement portion565C, the up/downmovement portion566C and the firststraight movement portion564C. In this process, theblade553 of themovable cutter55 moves from the top dead center to the first bottom dead center. Thus, theblade553 is pulled out from thesensor pack1C to become a state similar to that shown inFIG. 39B.
• After thebiosensor1C is accommodated again, theslider51 is moved relative to the base50 in the arrow E direction in the figure, whereby thesensor pack1C is disposed of in a manner similar to that in the first embodiment.
• In this embodiment, thesensor pack1C after use is disposed of with thebiosensor1C accommodated in the sensor pack. Therefore, thebiosensor13C can be disposed of integrally with the wrapping member, which reduces the number of parts to be disposed of and which is preferable from a hygienic point of view.
• As the biosensor for providing the sensor pack, use may be made of abiosensor13D shown inFIG. 41. In thebiosensor13D, the portion for engagement with theblade553D of the movable cutter in moving thebiosensor13 is provided at opposite sides of thebiosensor13D. Specifically, thebiosensor13D has opposite side edges each of which is provided with a pair ofprojections130D,131D. Ablade553D is inserted between theprojections130D and131D for engagement with theprojections130D,131D.
• Theprojection130D serves to engage with theblade553D when thebiosensor13D is moved in the arrow F direction, and also serve as a stopper for preventing the movement of thebiosensor13D relative to the sealing sheets or the base film of the sensor pack. Theprojection131D serves to engage with theblade553D when thebiosensor13D is moved in the arrow F direction.
• When thebiosensor13D is utilized, twoblades553 need be provided in the measurement mechanism.
• The present invention is not limited to the first and the second embodiments described above, and may be modified in various ways. For example, the sensor pack and the biosensor may have structures as shown inFIGS. 42-44.
• Thesensor pack1 shown inFIG. 42 includes abase film14, a sealingsheet12b, abiosensor13 and a sealingsheet12awhich are stacked in the mentioned order.
• The sensor pack shown inFIGS. 43A and 43B does not include a base film, and the biosensor is enclosed only by the sealingsheets12a,12b.
• In thebiosensor13 shown inFIG. 44, the electrodes134-136 are exposed continuously.
• The opening mechanism of the first embodiment can be used not only for opening the sensor pack in the analyzer but also for various purposes. For example, when a wrapping member contains an object in a solid state other than a biosensor or an object in a liquid or gel state, the opening mechanism can be used for opening the wrapping member to take out the content. The content may be taken out by a method similar to that of the above analyzer when the content is in a solid state. Alternatively, the content may be taken out by squeezing out with the use of a roller, regardless of the state of the content.

Claims (25)

1-19. (canceled)

20. An analytical tool accommodated in a wrapping member for providing an analytical tool pack and caused to project from the wrapping member in use, the analytical tool pack being made so that the analytical tool is moved by a pushing member relative to the wrapping member,

wherein the analytical tool includes an engagement portion with which the pushing member is engaged.

21. An analytical tool accommodated in a wrapping member for providing an analytical tool pack and including an end which is caused to project from the wrapping member in use of the analytical tool,

wherein the end is entirely rounded.

22. A cartridge including a container accommodating a plurality of analytical tool packs, each of the analytical tool packs including a wrapping member in which an analytical tool is accommodated,

wherein the container is formed with a through-hole communicating with an inside of the container and utilized for pushing out the analytical tool pack accommodated in the container.

23. The cartridge according toclaim 22, wherein the plurality of analytical tool packs are bundled and retained in the container.

24. A method of making an analytical tool pack comprising the steps of placing an analytical tool on a punch film or a sealing film, and bonding the sealing film to the punch film,

wherein the analytical tool is kept at an appropriate position relative to the punch film at least for a time period from when the placing step is completed and till when the bonding step is started.

25. The method of making the analytical tool pack according toclaim 24, wherein the position keeping is performed by using a suction unit.

26. A method of making an analytical tool pack comprising fixing an analytical tool to a sealing film or a punch film,

wherein the fixing step is performed simultaneously with respect to a plurality of analytical tools by using a plurality of pressing heads; and

wherein the pressing heads are capable of setting respective heights individually.

27. An analyzer for analyzing a sample by using an analytical tool pack including a wrapping member and an analytical tool accommodated in the wrapping member, the analysis being performed with the analytical tool caused to project from the wrapping member;

wherein the analyzer comprises an opening mechanism for making a cut in the wrapping member, and a pushing mechanism for moving the analytical tool relative to the wrapping member to cause the analytical tool to project through the cut.

28. The analyzer according toclaim 27, wherein, with the analytical tool caused to project from the wrapping member, the analyzer obtains output relating to analysis results from the analytical tool.

29. The analyzer according toclaim 27, wherein the pushing mechanism comprises a first and a second members which are movable relative to each other in a first direction, and a pushing member which is movable in a second direction crossing the first direction in accordance with the relative movement between the first and the second members, the pushing member serving to move the analytical tool relative to the wrapping member.

30. The analyzer according toclaim 29, wherein the pushing member is pivotally fixed to the first member while being connected to the second member for relative movement to the second member, and

wherein the second member is provided with a guide for moving a portion connected to the pushing member in the second direction.

31. The analyzer according toclaim 29, wherein the pushing member comprises a blade.

32. The analyzer according toclaim 29, wherein the pushing mechanism further comprises a holder for moving the wrapping member together with the first member or the second member.

33. The analyzer according toclaim 32, wherein the pushing mechanism further comprises a releaser for releasing the holding of the analytical tool by the holder.

34. The analyzer according toclaim 33, wherein the releaser increases a distance between the first member and the second member in the second direction when a particular positional relationship is established between the first member and the second member.

35. The analyzer according toclaim 27, further comprising a restorer for restoring the analytical tool projected from the wrapping member into the wrapping member for accommodation again.

36. The analyzer according toclaim 29, further comprising a restorer for restoring the analytical tool projected from the wrapping member into the wrapping member for reaccommodation,

wherein the restorer is provided by the pushing member.

37. The analyzer according toclaim 36, wherein the second member performs reciprocating movement between a first predetermined position and a second predetermined position relative to the first member twice in a single sample analysis operation,

wherein the pushing member engages with and moves the analytical tool to cause the analytical tool to project from the wrapping member when the second member moves from the first position toward the second position in the first reciprocating movement, and

wherein the pushing member engages with and moves the analytical tool to restore the analytical tool into the wrapping member when the second member moves from the second position toward the first position in the second reciprocating movement.

38. The analyzer according toclaim 37, wherein the second member is provided with a cam groove for controlling operation of the pushing member, and

wherein the cam groove has a configuration causing the pushing member to operate differently during the first reciprocating movement and during the second reciprocating movement.

39. The analyzer according toclaim 29, wherein the wrapping member comprises a sealing sheet, and a base film formed with a through-hole and bonded to the sealing sheet, and

wherein the opening mechanism includes a cutter for making a cut in the wrapping member, and

wherein the cutter and the pushing member move through the through-hole.

40. The analyzer according toclaim 27, wherein the opening mechanism includes an operation button, and a cutter which moves together with the operation button.

41. The analyzer according toclaim 27, further comprising an accommodation portion into which the analytical tool pack is to be loaded,

wherein the accommodation portion includes a pack orientation checker for preventing improper loading of the analytical tool pack into the accommodation portion.

42. The analyzer according toclaim 27, wherein the analyzer comprises a device body including an accommodation portion for accommodating a plurality of analytical tool packs, and a lid connected to the device body;

wherein the analytical tool packs are accommodated while being pressed against each other by a pressing member; and

wherein the lid is connected to the pressing member to release the pressing of the analytical tool packs in opening the accommodation portion.

43. An object taking-out mechanism for taking out an object from a pack in which the object is accommodated in a wrapping member;

the mechanism comprising an opening mechanism for making a cut in the wrapping member, and a pushing mechanism for pushing out the object through the cut.

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