JP2008237876A - Sensor device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To sufficiently introduce blood taken from a fingertip into a specimen space of a sensor chip in a lancet needle-integrated type sensor body in which a lancet needle is fixed to the sensor chip. <P>SOLUTION: The sensor device 1 is detachably equipped with a needle integrated type sensor body 20 including a sensor chip 100, a lancet needle 300 fixed to one end of a sensor chip 300, and a flow passage forming body 170 formed at the one end of the sensor chip 100, to which the lancet needle 300 is fixed, so as to be compressible and restorable. The sensor device 1 is provided with a piercing mechanism (drive spring 31) for inserting the sensor body 20 into a subject and a pressing mechanism (pressing spring 32) for biasing the sensor body 20 in a degree sufficient to prevent the sensor body 20 from separating from the subject by restoring force of the flow forming body 170 after the insertion. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a sensor device, specifically, a sensor device suitable for mounting a lancet needle integrated sensor body in which a biosensor chip and a lancet needle are integrated.

  A patient collects blood by using a lancet device for blood collection, and measures a blood sugar level or the like in the collected blood. The lancet device is generally composed of a lancet needle such as a puncture needle and a lancet main body for driving the lancet needle. is there.

  Conventionally, blood sugar levels and the like have been measured using such a lancet device and a separate measurement device. Recently, however, a combination of a biosensor and a lancet device is used to collect blood from a blood sample. A lancet-needle integrated sensor device has been proposed that can perform measurement up to a single operation.

  For example, the sensor device described in Patent Document 1 includes a chip body having an internal space, a lancet body having a lancet needle, and a device body on which the chip body is mounted. The lancet body is manufactured to be movable in the internal space of the chip body. After the lancet body is stored in the chip body, the lancet body is set in the device body, and the tip of the lancet needle is projected from the sample introduction port opened at the tip of the chip body by the driving device in the device body. .

  The chip body includes a substrate having a recess for forming an internal space and a cover in which a biosensor is configured. On the inner surface of the cover, a pair of electrodes constituting the biosensor and a terminal portion connected to the electrodes by wiring are provided. The electrode is provided so as to face a groove-like sample space extending from the sample introduction port to the internal space, and a biosensor is constituted by the electrode and a reagent layer applied to the surface of the electrode.

  However, this sensor device has a structure in which the needle is moved in the sample space between the substrate and the cover, and blood is introduced into the sample space from the sample introduction port at the tip of the chip body. Becomes larger. Moreover, since the sample inlet is relatively large and requires a large amount of blood, the pain to the patient is considerably large.

  On the other hand, sensor chips that are very small and can be mass-produced by a simple method have been developed. The biosensor chip shown in Patent Document 2 has almost the same structure as the biosensor chip shown in FIG. 4, and a cover and a substrate are formed by bending an insulating plate member, and both are formed by an adhesive layer. By bonding, a sample introduction port is formed at the tip of the chip, and a sample space for introducing blood is formed between the two. The plate member is formed with an electrode and an electrode connected with the electrode by a method such as sputtering, and the electrode provided near the sample inlet and the surface of the electrode and the vicinity thereof are applied. A biosensor is constituted by the reagent layer. Since this sensor chip has a structure in which plate members are bonded together, it is expected to be very thin and small, reduce the amount of blood required, and significantly reduce the physical burden on the patient. The

International Publication No. WO02 / 056769 International Publication No. WO05 / 010519

  By the way, when a lancet needle such as a needle and a biosensor chip are integrated, in order for blood to be introduced into the sample space from the sample inlet of the biosensor chip, it is necessary to sufficiently spread the blood to the sample inlet. However, when using a thin biosensor chip as in Patent Document 2, a needle having rigidity that can puncture the skin from the sample space to the sample introduction port (that is, a certain thickness is required). ), A structure in which the tip of the needle is popped out from the sample introduction port as in the sensor chip described in Patent Document 1, and then stored in the sample space is not feasible.

  Thus, it is conceivable to fix the needle to the upper surface or the lower surface of the cover of the biosensor chip described in Patent Document 2. However, since the sample introduction port of this biosensor chip is very narrow, there is a possibility that the blood does not sufficiently enter the sample space if the blood transmitted through the needle just contacts the sample introduction port. Further, since the sample introduction port is located away from the needle tip (needle axis), there is a risk that the blood that has bleed will not travel through the needle and reach the sample introduction port.

  On the other hand, it is also conceivable to fix the needle so as to be sandwiched between the folded plate members. In this case, since the needle protrudes from the sample introduction port, it is considered that blood can be easily induced as compared with the case where the needle is fixed to the upper surface (or the lower surface) of the biosensor chip. However, when the needle is removed from the fingertip, the sensor chip is also separated from the fingertip together with this, so that the blood that has bleed is not sufficiently distributed to the sample inlet.

  In either case, in order to bring the sample introduction port of the sensor chip closer to the blood (blood drop) that has bleed from the puncture site, the lancet needle that has been removed from the skin after puncture is brought closer to the puncture site, and the blood and sample introduction port are It may be possible to keep them in contact. However, if it is pushed with a strong force, the lancet needle will enter the puncture site again, bleeding will stop, and not only will blood not flow into the sample space, but it will also give the user pain again. It was thought that there would be a problem of becoming twice (through twice).

  The present invention has been made in view of the above background art, and the present invention relates to a sensor device in which a lancet needle integrated sensor body in which a lancet needle such as a puncture needle is fixed to a sensor chip is mounted. Even after the fingertip is removed, a blood flow path is secured between the puncture mark and the sample introduction port of the sensor chip, and the blood is filled therewith, so that the blood is forcibly introduced into the sample space. It is aimed.

  That is, the sensor device of the present invention includes a sensor chip, a lancet needle fixed to one end portion of the sensor chip, and a flow path provided to be compressed and restored at one end portion of the sensor chip to which the lancet needle is fixed. A sensor device that detachably attaches a needle-integrated sensor body comprising a formed body, and a puncture mechanism that punctures a subject with the needle-integrated sensor body, and a mechanism that is different from the puncture mechanism, It is characterized by having a pressing mechanism that urges the needle-integrated sensor body from the subject to be separated from the subject by the restoring force of the flow path forming body after puncturing.

  According to the present invention, sufficient blood can be distributed to the sample introduction port without the user passing it twice. Therefore, even if a thin and small biosensor chip as disclosed in Patent Document 2 is used, good measurement can be performed. That is, measurement can be performed with a small amount of blood. In addition, the sensor device itself can be made small.

  Hereinafter, the present invention will be specifically described with reference to the accompanying drawings. 1 is a schematic perspective view of a sensor device 1 of the present invention, FIG. 2 is a schematic internal structure diagram of the sensor device 1 equipped with a lancet needle integrated sensor body 20, and FIG. 4 is a schematic perspective view of the sensor chip 100 constituting the sensor main body 30, FIG. 5 is a schematic explanatory view in which a part of the sensor main body 30 is enlarged, and FIG. 6 is an operation explanatory view of the sensor device 1 of the present invention. is there.

  The sensor device 1 of the present invention has a device body 10 to which a sensor body 20 having a sensor chip 100 and a lancet needle 300 is detachably mounted. The sensor body 20 includes a sensor body 30 in which the sensor chip 100 and the lancet needle 300 are integrally formed, and a sensor body 40 for mounting on the device body 10. The sensor body 30 is formed by integrating a lancet needle 300, which is a puncture needle for damaging and bleeding the skin, and a small blade-like object, and a sensor chip 100 by a fixing member 150 and a support member 160. The sensor body 20 is provided as a so-called disposable product.

  As shown in FIG. 4, in the sensor chip 100, the cover 120 and the substrate 110 are bonded together with an adhesive layer 140 so as to form a sample space 130 between the cover 120, which is an insulating plate member, and the substrate 110. The sample introduction port 101 connected to the sample space 130 is opened at the tip of the sensor chip 100. Further, at the rear end of the sample space 130, vent holes 141 connected to the sample space 130 and the outside of the sensor chip 100 are extended on both sides thereof. A pair of electrodes 111 is formed on the substrate 110 so as to face the sample space 130. A voltage extraction terminal 112 electrically connected to the electrode 111 through a conductor is formed at the end of the substrate opposite to the sample introduction port 101. The cover 120 is provided with a reagent layer 121 that faces the sample space 130 and reacts with a sample (specifically, a body fluid such as blood). The pair of electrodes 111 and the reagent layer 121 constitute a biosensor. Examples of such a sensor chip 100 include a chip in which a plate member as described in Patent Document 2 is bent to produce a substrate and a cover. However, in the present invention, the structure shown in Patent Document 2 does not matter, and the sample introduction port 101 is provided between the substrate 110 and the cover 120, and the sample is introduced from the sample introduction port 101. Any structure can be applied.

  The lancet needle 300 is disposed on the cover 120 of the sensor chip 100 and is fixed to the sensor chip 100 by being sandwiched between the fixing member 150 and the support member 160. The lancet needle 300 is fixed by protruding the tip of the lancet needle 300 from the tip of the sensor chip 100 in order to damage the skin (subject). Further, the lancet needle 300 is arranged so that the axis of the lancet needle 300 is substantially parallel to the arrangement direction of the sample space 130 so that the bodily fluid coming out of the skin can be quickly guided to the sample introduction port 101. It is arranged so as to be close to 101, preferably just above the sample inlet 101. In the present invention, since the flow path forming body 170 is mounted as described later, as long as the flow path forming body 170 is positioned within the flow path 171 (flow path cross section) formed by the flow path forming body 170, the sample introduction port 101 is somewhat It does not matter if it is in a remote location.

  The support member 160 has a function of holding the sensor chip 100 from the lower surface of the sensor chip 100, and is made of, for example, a plastic material. In addition, the support member 160 includes a wing portion 161 that can be easily held between two fingers so that the support member 160 can be easily fixed to the sensor body 40 or attached to and detached from the device body 10. The fixing member 150 has a function of protecting the sensor chip 100 from the upper surface of the sensor chip 100, and is made of, for example, a plastic material. The fixing member 150 also has a function of fixing the lancet needle 300, and a notch (not shown) for fixing the lancet needle 300 is formed on the lower surface thereof. Of course, the fixing member 150 and the support member 160 may be integrally formed.

  The sensor body 30 is attached to a sensor body 40 having a substantially cylindrical shape as shown in FIG. 3, for example. The sensor body 40 is used for mounting on the device main body 10 and electrically connects a terminal 112 of the sensor chip 100 and a measurement circuit (not shown) of the device main body 10 inside thereof. Connector 41 is provided. Further, a cylindrical drive spring mounting portion 42 having a smaller outer diameter than the front end side of the body is provided on the rear end side of the sensor body 40, and the inside of the cylinder is a pressing spring mounting portion 43. Yes.

  A flow path forming body 170 is provided on the front surface of the sensor body 20 as shown in FIGS. As will be described later, the flow path forming body 170 promptly guides the body fluid flowing out from the puncture site to the sample introduction port 101. The flow path forming body 170 shown in the figure is produced in a substantially cylindrical shape, and the inside of the cylinder is a flow path 171 through which a body fluid flows. In the flow path forming body 170, the axis of the lancet needle 300 and the sample introduction port 101 are positioned in the back surface opening 173 of the flow path forming body 170. Further, the back opening end thereof is in close contact with the front surface of the sensor body 20 (sensor body 30) so that the body fluid does not leak from the flow path 171 to the outside. As this attachment method, for example, a projection (not shown) is provided on the fixing member 150 and the support member 160 of the sensor body 20, and the rear opening 173 of the flow path forming body 170 is covered on the tip of the sensor body 20. It is conceivable to stop the sensor body 40 or to cover the front end of the sensor body 40 with the rear opening 173 of the flow path forming body 170. But the flow path formation body 170 should just be able to form the flow path 171 in the inside, and may make the front-end | tip opening a lid | cover and open the puncture hole 172 in the cover part.

  The flow path forming body 170 is produced in such a size that the tip of the lancet needle 300 is positioned inside the puncture hole 172 when it is attached to the sensor body 30 in a natural state. It also has the function. The flow path forming body 170 is a polymer material having elasticity and airtightness, for example, rubber such as silicone, urethane, acrylic rubber, etc., rubber or sponge made of a single polymer such as ethylene or styrene, or a polymer copolymerized therewith, polyethylene and polypropylene And the like, polyesters such as PET and PBT, and fluororesins such as PTFE and PFA. The airtightness is sufficient if it does not allow body fluid to pass, and the elastic force is compressed so that the tip of the lancet needle 300 pops out from the puncture hole 173 when the sensor body 20 popped out from the device 1 collides with the skin. Then, it is necessary to restore the lancet needle 300 that has pierced the skin to such an extent that it can be removed from the skin. Then, the body fluid that has flowed out from the puncture site (puncture mark) from which the lancet needle 300 has been removed is guided to the sample introduction port 101 from the flow channel 171 formed inside the flow channel formation body 170.

  The sensor body 20 provided with the flow path forming body 170 is attached to the device body 10 by inserting the vicinity of the proximal end of the wing portion 161 into the guide slit 44 of the sensor body 40 (see FIG. 1). The device main body 10 has a puncture mechanism for puncturing the mounted sensor body 20 against the skin, a conversion circuit for converting an electromotive voltage generated in the sensor chip 100 into a measured value, and a display mechanism for displaying the measured value. (Not shown). The puncture mechanism is constituted by a spring mechanism, for example. The spring mechanism includes a drive spring 31 provided at the rear portion of the sensor body 20 and a holding mechanism that holds the drive spring 31 in a compressed state and releases the hold state by the drive button 11. The drive spring 31 is attached to the sensor body 40 so that the drive spring mounting portion 42 is inserted into a part of the distal end side, and the other end can be pressed into the wall surface 14 at a predetermined position of the device body 10 in the device body 10. Stored. Further, the illustrated drive spring 31 is not fixed to the device body 10 and can move with the natural length when the contracted drive spring 31 returns to the natural length. Of course, one end of the drive spring 31 may be fixed to the device body 10 (for example, the wall surface 14).

  The holding mechanism includes a hook fixing recess 45 formed in the sensor body 40, a hook member 46 that interlocks with the drive button 11, and a holding spring 47. The holding spring 47 urges the drive button 11 upward (in the push-up direction), and locks the hook 48 provided at the tip of the hook member 46 in the recess 45. When the sensor body 20 is inserted into the device body 10, the hook 48 at the tip of the hook member 46 engages with the recess 45 and holds the drive spring 31 in a compressed state. Next, when the drive button 11 is pressed, the hook 48 is released from the recess 45 and the drive spring 31 is released. As a result, the sensor body 20 jumps out forward with its restoring force. As a result, the lancet needle 300 that has collided with the skin overcomes the repulsive force of the flow path forming body 170 and its tip pierces the skin. Thereafter, the lancet needle 300 is detached from the skin by the restoring force of the flow path forming body 170, and the body fluid flowing out from the skin flows into the flow path 171.

  Further, in the sensor device 1 of the present invention, a pressing mechanism is provided in order to fill the flow path 171 of the flow path forming body 170 with the body fluid and sufficiently ensure the flow of the body fluid. The pressing mechanism may be any mechanism that can press the flow path forming body 170 that collides with the skin against the skin and secure the flow path 171 until the end of the measurement. For example, a pressing spring 32 is used as the pressing mechanism. The pressing spring 32 is mounted by inserting its tip into the pressing spring mounting portion 43 of the sensor body 20. The rear end of the pressing spring 32 is fixed to a predetermined wall surface 15 in the device body 10. When the sensor body 20 is mounted in the device body 10, the pressing spring 32 is stored in the device body 10 in a compressed state, and urges the sensor body 20 toward the distal end side. When the drive spring 31 is released by the operation of the drive button 11, the sensor body 20 (flow path forming body 170) is urged toward the skin by the restoring force, and the front surface of the flow path forming body 170 is brought into contact with the skin. . That is, when operated only by the drive spring 31 without the pressing spring 32, the lancet needle 300 is detached from the skin by the restoring force of the flow path forming body 170, and body fluid flows into the flow path 171. Since it is in a free state, the front surface of the flow path forming body 170 is separated from the skin, and the flow of fluid (flow path) is interrupted. For this reason, the body fluid is not sufficiently filled in the flow channel 171, and a necessary amount of body fluid may not flow into the sample space 130. Therefore, in the present invention, the flow path forming body 170 is pressed against the skin even after puncture by the pressing spring 32 so that the blood flows in the flow path 171 sufficiently even after the lancet needle 300 is detached from the skin. I have to. When the flow path forming body 170 is positioned near the skin immediately after puncture so that such a function can be achieved, the restoring force of the pressing spring 32 is at least substantially the same as the restoring force of the flow path forming body 170. Is desired to be smaller. However, even if the restoring force of the pressing spring 32 is smaller than the restoring force of the flow path forming body 170, the natural length of the pressing spring 32 is the length for pressing the flow path forming body 170 to the skin at the minimum. is required. Moreover, as long as the flow path 171 is filled with the body fluid and the flow of the body fluid can be secured, the front surface of the flow path forming body 170 may be slightly separated from the skin. On the other hand, even if the restoring force of the pressing spring 32 is larger than the restoring force of the flow path forming body 170, the lancet needle may come off from the skin due to the repulsive force at the time of collision with the skin. However, it is necessary that the restoring force of the pressing spring 32 is not so great that the lancet needle that has come out of the skin is prevented from puncturing the skin again.

  Further, in order to protect the mounted sensor body 20, the device body 10 is usually provided with a cap body 16 detachably at the distal end portion of the device body 10. At the time of puncturing, since the tip of the cap body 16 is punctured against a fingertip or the like, the puncturing location is located inside the tip of the cap body 16. Therefore, if the cap body 16 is not provided or if the entire device 1 is assumed to be disposable, the restoring force of the pressing spring 32 may be as described above.

  However, when the cap body 16 is provided, if the flow path forming body 170 is positioned inside the cap body 16 after puncturing, body fluid attached to the flow path forming body 170 may adhere to the cap body 16, When removing the sensor body 20, body fluid contaminates the inner surface of the cap body 16, and a situation that is not preferable for repeated use of the device body 10 is assumed.

  Therefore, when the fingertip is released from the tip of the cap body 16, the pressure spring has a restoring force that can restore the front surface of the flow path forming body 170 to the front of the tip opening (launch port) of the cap body 16. 32, that is, it is preferable to use the pressing spring 32 having a natural length longer than the distance from the fixed wall surface 15 of the pressing spring 32 in the device body 10 to the tip of the cap body 16. Of course, it is possible to use the pressing spring 32 having such a length that the entire flow path forming body 170 protrudes beyond the tip of the cap body 16. As a result, when the fingertip is separated from the device 1 after puncturing, the front surface of the flow path forming body 170 is positioned outside the cap body 16, and contamination of the cap body 16, particularly the inner surface thereof is prevented.

  That is, in the present invention, regardless of the presence or absence of the cap body 16, the structure of the device body 10, for example, the cap, is achieved in order to achieve these purposes (securing the flow path after puncturing and preventing contamination of the cap body 16). Depending on the presence / absence of the body 16, the distance from the fixing position of the pressing spring 32 to the front surface of the flow path forming body 170, the length of the flow path forming body 170, etc. The elastic force of the body 170 is adjusted comprehensively.

  Next, the operation of the sensor device 1 of the present invention will be described as follows based on the operation explanatory diagram of FIG. First, when the sensor body 20 to which the flow path forming body 170 is attached is inserted deeply into the device body 10, the hook 48 of the driving mechanism is fitted into the recess 45 of the sensor body 40, and the driving spring 31 and the pressing spring 32 are compressed. In a state, it is set at a predetermined position (see FIG. 2). When the sensor body 20 is set in the device body 10, the measurement circuit is turned on, and when the drive button 11 is pressed with the fingertip pressed against the tip of the cap body 16, the hook 48 is detached from the recess 45 and the drive spring 31. And the pressing spring 32 extends. Then, the sensor body 10 vigorously collides with the fingertip, and the tip of the lancet needle 300 protruding from the puncture hole 172 of the compressed flow path forming body 170 is pierced into the fingertip (FIG. 6A). Thereafter, the distal end of the lancet needle 300 is removed from the fingertip by the restoring force of the flow path forming body 170 and the front surface of the flow path forming body 170 is maintained in substantially contact with the fingertip by the restoring force of the pressing spring 32 (FIG. 6). (B)). When the fingertip is removed from the sensor device 1 after the measurement is finished, the flow path forming body 170 is further pushed forward by the restoring force of the pressing spring 32, and the front surface of the flow path forming body 170 is moved from the tip of the cap body 16. In the protruding state, the flow path forming body 170 stops (FIG. 6C). Thereafter, the sensor body 20 is detached from the device body 10 to finish the measurement. When the sensor body 20 is detached from the device body 10, the measurement circuit is turned off, and the removed sensor body 20 is discarded.

  As described above, in the sensor device 1 of the present invention, the substantially cylindrical flow path forming body 170 that can be compressed and restored in the puncture direction of the lancet needle 300 is provided at the tip of the sensor chip 100. Is provided with a pressing mechanism, for example, a pressing spring 32, that urges the distal end surface of the flow path forming body 170 in the fingertip direction so as not to contact the fingertip. A flow path through which the blood that has flowed out is ensured, and a sufficient amount of blood is supplied in the vicinity of the sample introduction port 101. Then, blood is quickly supplied from the sample introduction port 101 to the sample space 130. In addition, since a force can be applied to the flow path forming body filled with blood in the compressing direction, the blood can be further spread from the sample introduction port into the sample space of the biosensor chip. As a result, accurate measurement can be performed even using a very small sensor chip 100 as disclosed in Patent Document 2. Therefore, the examination can be performed with a very small amount of blood collected, and pain to the patient is considerably reduced. Moreover, since the force in the compressing direction presses the tip of the lancet needle so that the tip of the lancet needle does not contact the surface to be punctured, the puncture mark is not blocked by the needle tip, and the user may be again pained. Absent.

  When the sensor device 1 includes the cap body 16, the restoring force of the pressing spring 32 so that the front surface of the flow path forming body 170 protrudes from the tip of the cap body 16 when the fingertip is released after puncturing. Is adjusted so that contamination of the body fluid on the inside of the cap body 16 is prevented, and the device body 10 can be used repeatedly in a sanitary manner without being forced to replace the cap body 16.

  In the above embodiment, the case where the sensor chip 100 in which the lancet needle 300 is disposed on the upper surface is used has been described. For example, as illustrated in FIG. 7, the lancet needle 300 is provided between the cover 120 made of a plate member and the substrate 110. The sensor chip 100 in which the axis of the lancet needle 300 is positioned in the sample introduction port 101 formed between the cover 120 and the substrate 110 can also be used. Although not shown, the lancet needle 300 can be disposed on the lower surface.

  Next, still another embodiment of the present invention will be described. 8 is a schematic perspective view of the sensor device 1, FIG. 9 is a schematic perspective view showing a state where the lid 210 is opened, FIG. 10 is a schematic sectional view showing a state where the lid 210 is opened, and FIG. 11 is shown in FIG. FIG. 12 is a diagram showing a spring connector 270 that connects the drive spring 31 and the pressing spring 32, and FIG. 13 is a diagram showing a lid body 210 to which the sensor body 20 is attached. FIG. 14 is a schematic cross-sectional view of the sensor device 1 with the sensor body 20 attached and the lid body 210 opened.

  The sensor device 1 has a sensor body 20 and a device body 10 to which the sensor body 20 is detachably attached. The sensor body 20 includes a sensor body 30 in which the sensor chip 100 and the lancet needle 300 are integrally formed, and a sensor body 40 for mounting on the sensor body 30. The sensor body 30 is an integrated body in which the lancet needle 300 and the sensor chip 100 are sandwiched between a fixing member 150 and a support member 160. The sensor main body 30 has the same configuration as that of the sensor main body 30 of the first embodiment, but the support member 160 does not have the wing portion 161, and the sensor main body 30 has a substantially cylindrical shape as a whole. The lengths of the fixing member 150 and the support member 160 are shorter than the length of the sensor chip 100, and the terminal 112 of the sensor chip 100 is in a position protruding rearward from the sensor body 30. The sensor body 40 is composed of two semi-cylindrical body forming members 40 a and 40 b and does not have the drive spring mounting portion 42, the pressing spring mounting portion 43, and the connector 41. The lengths of the body forming members 40a and 40b are shorter than the length of the sensor chip 100, and are almost the same as the lengths of the fixing member 150 and the support member 160, and the terminals 112 of the sensor chip 100 are located rearward from the sensor body 40. It is in the position that popped out. And the attachment location of the flow-path formation body 170 with which the front surface of the sensor main body 20 was mounted | worn is pinched | interposed by the two body formation members 40a and 40b.

  The device body 10 includes a lid body 210 and a housing 220 that house a measurement circuit and a display mechanism (both not shown). The lid 210 is attached to the housing 220 through an attachment member 221 so as to be opened and closed. The housing 220 has a box shape with an upper surface opened. A cylindrical contact member 230 is provided on the front surface of the housing 220, and a launch port 231 is provided. By applying the contact member 230 to the puncture target surface, the puncture target site is raised in the launch port 231 to facilitate bleeding. However, the contact member 230 is not an essential member, and the launch port 231 may be formed directly in the housing 210.

  The housing 220 has a fixed frame 240 having a rectangular frame shape in plan view fixed in the housing 220. Further, the housing 220 includes a fixed socket 250 and a movable socket 260 in which the sensor body 20 is detachably mounted in the fixed frame 240 and moves in the mounting direction of the center body 20 in the fixed socket 250. The movable socket 260 is formed in a substantially rectangular tube shape, and four inner corners are squared inside the square frame in order to temporarily hold the sensor body 20 inserted from the front in the tube. The fixed socket 250 has a rectangular tube shape, and is attached to the fixed frame 240 so as to be rotatable around the rotation member 252 at the lower rear portion of the fixed socket 250. The inner frame of the fixed socket 250 is formed in substantially the same shape as the outer frame of the movable socket 260, and is attached so that the movable socket 260 can freely slide along the inner frame of the fixed socket 250. A large opening 255 is formed on the upper surface of the fixed socket 250.

  On the upper surface of the movable socket 260, a rail 214 is provided in the opening 255 of the fixed socket 250 in the attaching / detaching direction of the sensor body 20. One end of the column 211 is attached to the mounting member 213 moving on the rail 214 so that the angle formed by the rod-shaped column 211 connected to the rail 214 and the lid 210 changes. The other end of the column 211 is attached to the back surface of the lid 210 by another mounting member 212 so that the angle formed by the column 211 and the lid 210 can be changed. The support column 211 can be expanded and contracted, and is fixed to a fixed length when extended or shortened.

  The rail 214 has stoppers (not shown) at both ends thereof. When the lid 210 is closed, the mounting member 213 moves forward with the column 211 contracted, and is positioned at the front stopper position. When the lid 210 is opened, the strut 211 in a contracted state is stretched according to the opening of the lid 210. Then, when the lid 211 is opened until the column 211 is extended to the maximum, the attachment member 213 moves rearward on the rail 214 in accordance with the opening of the lid 210. Thereafter, after the mounting member 213 has moved to the rear stopper position, the movable socket 260 is pulled up according to the opening of the lid 210, and the fixed socket 250 rotates around the rotating member 252. When the lid 210 is opened, the front of the movable socket 260 is pulled up in this way (see FIG. 10). When the lid 210 is closed, the movable socket 260 is placed in a horizontal position together with the fixed socket 250 when the lid 210 is closed by the opposite movement (see FIGS. 13 and 14). In addition, an electrical switch (not shown) is disposed on the rear stopper, and when the mounting member 213 moves to the front stopper position, the switch is turned on and the measurement circuit is turned on. When the lid 210 is opened and the attachment member 231 moves rearward from the front stopper position, the switch is turned off and the measurement circuit is turned off.

  The movable socket 260 includes a connector 261 that is electrically connected to the terminal 112 of the sensor chip 100 in the vicinity of the center of the sensor body 20 in the insertion direction. The connector 261 exposes an extraction terminal 262 for electrical connection to the measurement circuit. Then, a conductive wire (not shown) that electrically connects the extraction terminal 262 and the measurement circuit is drawn out from the electrode outlet 263 of the movable socket 260 and the opening 255 of the fixed socket 250. The movable socket 260 has a cylindrical spring arrangement space 265 in which the drive spring 31 and the pressing spring 32 extend and retract in the attaching / detaching direction of the sensor body 20 behind the electrode connecting connector 261.

  This sensor device 1 also has a puncture mechanism that allows the sensor body 20 to jump out and collide with the surface of the puncture target, such as skin, and the flow path forming body 170 that collides with the skin after puncture is pressed against the surface of the puncture target. A pressing mechanism having a pressing spring 32 for securing the path 171 is provided. The puncture mechanism includes a driving spring 31 disposed behind the sensor body 20 and a holding mechanism that holds the driving spring 31 in a compressed state and releases the holding state by the driving button 11.

  The holding mechanism includes a hook fixing recess 45 formed on the lower surface of the movable socket 260, a hook member 46 that interlocks with the drive button 11, the drive button 11, the push pin 12, and the return spring 13. The hook member 46 is formed in an L shape and is pivotally supported on the rotation shaft 49 at a portion bent in the L shape. Further, the hook member 46 has a hook 48 that is engaged with the recess 45 at one end. Therefore, when the lid 210 is opened, the movable socket 260 moves rearward, so that the hook 48 is locked in the recess 45.

  The drive button 11 is provided on the back surface of the housing 220 and is urged in the back direction by a return spring 13 provided between the inner surface of the housing 220 and the back surface of the fixed frame 240. The push button 12 is provided on the back surface of the drive button 11 to push the other end of the hook member 46 (the end without the hook 48). Therefore, when the drive button 11 is pressed, the push pin 12 jumps forward and the hook 48 is removed from the recess 45, and the drive spring 31 tries to return to its natural length by its restoring force. Further, the push pin 12 moves into the shaft of the drive button 11 in conjunction with the opening of the lid 210, and the tip of the push pin 12 is located at a position where the rotation of the fixed socket 250 is not hindered (see FIG. 10). .

  The pressing spring 32 is arranged in series with the driving spring 31 via the spring connector 270 inside the movable socket 260. When the pressing spring 32 is arranged inside the drive spring 31 as in the sensor device 1 shown in FIG. 1, the two springs are entangled during assembly, and the assembly cannot be performed properly, or the two springs are entangled during operation. There was concern that it would not work properly. In this regard, such a concern is solved by arranging the drive spring 31 and the pressing spring 32 in series.

  The drive spring 31 and the pressing spring 32 are arranged in series in the spring arrangement space 265 via the spring connector 270. The spring connector 270 is formed in a cylindrical shape as shown in FIG. The spring connector 270 moves in the spring arrangement space 265 in the attaching / detaching direction of the sensor body 20. The spring connector 270 has a protrusion 271 that holds one end of the pressing spring 32 on the front surface, and the protrusion 271 is inserted into one end (rear end) of the pressing spring 32. A rear surface of the spring connector 270 has a recess 272 for inserting and supporting one end of the drive spring 32.

  The electrode connection connector 261 has a protrusion 264 that holds one end of the pressing spring 32 on the back surface thereof, and the protrusion 264 is inserted into the end (front end) of the pressing spring 32. The pressing spring 32 is supported by the two protrusions 271 and 264 and is held in the spring arrangement space 265 of the movable socket 260. In addition, one end (front end) of the drive spring 31 is fixed to the protrusion 253 on the inner surface of the fixed socket 250, and the drive spring 31 is supported between the recess 272 of the spring connector 270 and held in the spring arrangement space 265. Is done.

  When the lid 210 is opened, the movable socket 260 moves rearward, and the tip of the movable socket 260 is lifted as shown in FIG. In this state, the driving spring 31 and the pressing spring 32 are maintained in a compressed state by the holding mechanism. In this state, when the sensor body 20 is inserted and attached to the movable socket 260 and the lid body 210 is closed, the fixed socket 260 is set in a horizontal state and becomes measurable (see FIGS. 13 and 14).

  The drive spring 31 has a function of causing the sensor body 20 to collide with the surface to be punctured, and thus has a large restoring force and requires a considerably strong force to compress it. However, in this sensor device 1, since the movable socket 260 moves rearward when the lid 210 is opened, the drive spring 31 can be compressed with a relatively small force. Further, when the drive spring 31 tries to return to the natural length, the spring connector 270 is pushed forward with a large restoring force. After the sensor body 20 collides with the puncture target surface, a force is applied in a direction in which the drive spring 31 is temporarily compressed by the restoring force of the flow path forming body 170, but the driving spring 31 has a large restoring force. Therefore, the drive spring 31 does not shrink.

  Since the pressing spring 32 collides with the surface to be punctured and is supported by the drive spring 31 via the spring connector 270, the front surface of the flow path forming body 170 is pressed against the surface to be punctured by the restoring force of the pressing spring 32 itself. Can do. At this time, the restoring force of the pressing spring 32 is adjusted so that the tip of the lancet needle 300 does not touch the puncture target surface. But since the flow path formation body 170 should just contact the puncture object surface, the press spring 32 may return to natural length. Furthermore, it is preferable that the pressing spring 32 has a restoring force that allows the front surface of the flow path forming body 170 to be positioned in front of the launch port 231 after the measurement is completed. In other words, when the pressing spring 32 returns to the natural length, it is desirable that at least the front surface of the flow path forming body 170 is positioned in front of the launch port 231. By doing so, blood adhering to the front surface of the flow path forming body 170 is prevented from adhering to the inner surface of the contact member 230. On the other hand, when the lid 210 is open, it is preferable that the tip surface of the movable socket 260 is kept protruding from the tip surface of the fixed socket 250 as shown in FIG. For this purpose, the pressing spring 32 needs a restoring force to push out the movable socket 260 without being compressed by its own weight when the lid 210 is opened. That is, also in this sensor device 1, depending on the structure of the device body 10, for example, the mass and length of the movable socket 260, the length of the fixed socket 250, the length of the drive spring 31, the size of the spring socket 270, etc. Thus, the spring constant and the length of the pressing spring 32 and the elastic force of the flow path forming body 170 are adjusted comprehensively.

  Next, the operation of the sensor device 1 of the present invention will be described as follows based on the operation explanatory diagram of FIG. With the sensor body 20 mounted on the movable socket 260 and the lid body 210 closed, the contact member 230 is pressed against the puncture target surface, for example, the fingertip M. When the drive button 11 is pressed, the hook 48 is removed from the recess 45 and the drive spring 31 and the press spring 32 are extended. Then, the sensor body 20 vigorously collides with the fingertip, and the tip of the lancet needle 300 protruding from the puncture hole 172 of the compressed flow path forming body 170 pierces the fingertip M (FIG. 15A). Thereafter, the tip of the lancet needle 300 is removed from the fingertip by the restoring force of the flow path forming body 170 and the front surface of the flow path forming body 170 is maintained in contact with the fingertip M by the restoring force of the pressing spring 32 (FIG. 15). (B)). Then, after finishing the measurement, when the fingertip is separated from the sensor device 1, the flow path forming body 170 is further pushed forward by the restoring force of the pressing spring 32, and the front surface of the flow path forming body 170 is separated from the tip of the cap body 16. The flow path forming body 170 stops in the protruding state (FIG. 15C). Thereafter, the sensor body 20 is pulled out from the distal end opening of the puncture portion, and the measurement is finished.

  Thus, the drive spring 31 and the pressing spring 32 are arranged in series via the spring connector 270 so that the flow path forming body 170 is pressed against the puncture target surface by the pressing spring 32 after the sensor body 20 collides. Good. This configuration facilitates assembly and ensures operation.

  Of course, the present invention is not limited to the above embodiments, and various embodiments are possible. For example, the sensor body 40 constituting the sensor body 20 is not an essential constituent element, and the sensor body 30 in which the lancet needle 300 is integrally formed may be directly attached to the device body 10. Further, as a puncture mechanism that causes the sensor body 20 to jump out and collide with the skin, a puncture mechanism using compressed air or a puncture mechanism using the rotational force of a motor can be used.

  According to the present invention, there is provided a measuring apparatus that can reduce a physical burden on a patient. Since this measurement apparatus can reliably measure even a small amount of blood, a very small biosensor chip can be used. In addition, the sensor device itself is miniaturized, and a sensor device that is convenient to carry is provided.

It is a schematic perspective view of the sensor device of the present invention. It is a schematic internal structure figure of the sensor device equipped with the sensor body. It is the schematic perspective view which fractured | ruptured the sensor body with which a sensor device is mounted | worn partially. It is a schematic perspective view of the sensor chip which comprises a sensor main body. It is the schematic explanatory drawing which expanded a part of sensor main part, (a) is the front view, (b) is the sectional drawing. It is operation | movement explanatory drawing of the sensor device of this invention. It is the schematic explanatory drawing to which a part of sensor main body which is another embodiment was expanded, (a) is the front view, (b) is the sectional drawing. It is a schematic perspective view of the sensor device which is another embodiment of this invention. It is a schematic perspective view which shows the state which opened the cover body. It is a schematic sectional drawing which shows the state which opened the cover body. It is the schematic perspective view which fractured | ruptured partially the sensor body with which the sensor device shown in FIG. 8 is mounted | worn. It is a figure which shows the spring connector which connects a drive spring and a press spring, Comprising: (a) is the perspective view, (b) is the sectional drawing. It is a schematic plan view of the sensor device with the sensor body mounted and the lid body opened. It is a schematic sectional drawing of the sensor device with which the sensor body was mounted | worn and the cover body was opened. It is operation | movement explanatory drawing of the sensor device shown in FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Sensor device 10 Device main body 11 Drive button 15 Wall 16 of the device main body which fixes one end of a press spring Cap body 20 Sensor body 30 Sensor main body 31 Drive spring 32 Press spring 40 Sensor body 41 Connector 42 Drive spring mounting part 43 Press spring mounting Portion 44 Guide slit 45 Recess 46 Hook member 47 Holding spring 48 Hook 100 Sensor chip 101 Sample inlet 110 Substrate 120 Cover 121 Reagent layer 130 Sample space 140 Adhesive layer 150 Fixing member 160 Support member 161 Wing portion 170 Flow path forming body 171 Flow path 172 Puncture hole 173 Back opening 210 Lid 220 Housing 240 Fixed frame 250 Fixed cassette 260 Movable cassette 270 Spring connector 300 Lancet needle

Claims (5)

A needle integrated type comprising: a sensor chip; a lancet needle fixed to one end of the sensor chip; and a flow path forming body provided to be compressed and restored at one end of the sensor chip to which the lancet needle is fixed. A sensor device for detachably mounting a sensor body,
A puncture mechanism for puncturing the subject with the needle-integrated sensor body;
It is a mechanism different from the puncture mechanism, and has a pressing mechanism that urges the needle-integrated sensor body from the subject to be separated from the subject by the restoring force of the flow path forming body after puncturing. Sensor device.   The sensor device includes a cap body having an opening for puncturing the subject with a lancet needle, and the pressing mechanism is configured so that at least the front surface of the flow path forming body is at least when the subject is separated from the opening of the cap body after puncturing. 2. The sensor device according to claim 1, wherein the sensor device is biased to the extent that it protrudes from the opening of the cap body.   The sensor device according to claim 1, wherein the pressing mechanism and / or the puncturing mechanism includes a spring mechanism.   The sensor device according to any one of claims 1 to 3, wherein the flow path forming body is made of a polymer material having airtightness and elasticity.   The said sensor chip is comprised by the cover and board | substrate which consist of plate members, and the sample space with which a sample and a reagent layer react between the cover and the board | substrate was provided. A sensor device according to one claim.

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