WO2014162383A1

WO2014162383A1 - Sensor retention device and vital sign measurement system

Info

Publication number: WO2014162383A1
Application number: PCT/JP2013/059821
Authority: WO
Inventors: 大越隆弘; 松本淳
Original assignee: テルモ株式会社
Priority date: 2013-04-01
Filing date: 2013-04-01
Publication date: 2014-10-09

Abstract

A blood glucose measurement system (12) which is a vital sign information measurement system comprises: a sensor (14) which is retained such that at least a portion is exposed upon the surface of the body of a subject for measurement, and which is capable of detecting vital sign information of the subject for measurement; and a sensor retaining device (10), further comprising a transmitter (24) which processes a signal which includes the vital sign information from the sensor (14). The blood glucose measurement system (12) further comprises an insertion device (16) for holding the sensor retaining device (10) and inserting the sensor (14) into the body of the subject for measurement, and after the insertion into the body, covers the sensor (14) which is exposed on the surface of the body in a non-contact state with a cover (20).

Description

Sensor indwelling device and biological information measuring system

The present invention relates to a sensor placement device and a biological information measurement system that are placed on a body surface of a measurement target and acquire biological information of the measurement target.

Conventionally, a sensor is placed on a person to be measured (patient), and an analyte (eg, glucose, pH, cholesterol, protein, etc.) in blood or body fluid is continuously detected by the sensor, and the detection result is detected by the person to be measured. Treatment managed as biometric information is performed. For example, by inserting a sensor into the body of a person to be measured and continuously measuring glucose in the blood (also called Continuous Glucose Monitoring: CGM), the fluctuation of the blood glucose level can be ascertained. It is useful for blood sugar management.

JP 2002-526137 A discloses a remote trait monitor system (blood glucose measurement system) that implements this CGM. The blood glucose measurement system includes a sensor that detects a blood glucose level, a transmitter that transmits blood glucose level information detected by the sensor, and a data receiving device that receives blood glucose level information of the transmitter. The blood glucose measurement system has a state in which the blood glucose level can be transmitted by the tip of the sensor being punctured under the subject's skin and the base end exposed to the body surface of the subject and connected to the transmitter. Become. The blood glucose level is automatically measured while the measurement subject is living with the sensor and the transmitter placed on the body surface.

By the way, the sensor is placed in a place where the subject's body surface is relatively difficult to receive external force, but from various things in the measurement subject's life (for example, the measurement subject's clothes), Receives external force from contact. When the external force is directly applied to the sensor in this way, there is a possibility that inconveniences such as removal of the sensor or indwelling of the sensor or failure of the sensor (for example, wiring becomes poor contact) may occur.

The present invention has been made in order to overcome the above-described disadvantages, and prevents the transmission of external force directly to the sensor placed on the body surface of the object to be measured with a simple configuration, thereby stabilizing the sensor. It is an object of the present invention to provide a sensor indwelling device and a biological information measurement system that can be used for the purpose of grasping and managing biological information satisfactorily.

In order to achieve the above object, a sensor indwelling device according to the present invention is a sensor indwelled so that at least a part thereof is exposed on a body surface of a measurement target and capable of detecting biological information of the measurement target. A signal processing unit that is connected to the sensor and processes a signal including biological information from the sensor, and a cover that covers the sensor exposed to the body surface in a non-contact state.

Based on the above, the sensor indwelling device can prevent an external force directly directed to the sensor exposed on the body surface of the measurement target from being covered by the cover by a simple configuration including the cover that covers the sensor in a non-contact manner. . Therefore, the sensor indwelling device can stably use the sensor while suppressing inconveniences such as the sensor coming off due to an external force applied or the failure of the sensor. As a result, it is possible to satisfactorily grasp and manage the biological information acquired by the sensor.

In this case, the sensor is held by a sensor holder that is affixed to the body surface via a first affixing unit, and the signal processing unit is a signal process that is affixed to the body surface via a second affixing unit. Preferably, the sensor holder and the signal processing unit holder are held on the body surface in a non-contact manner.

Thus, even if an external force is applied to the signal processing unit or the signal processing unit holder because the sensor is held by the sensor holding unit and the sensor holding unit is not in contact with the signal processing unit holding unit, the sensor In contrast, it is possible to prevent external force from being applied directly. Therefore, the sensor can be used more continuously and stably.

Further, it is preferable that the signal processing unit holder has a hole in which the sensor holder can be arranged in a non-contact manner, and the cover is fitted to a frame surrounding the hole.

In this way, the cover and the sensor can be surely brought into a non-contact state by fitting the cover to the frame surrounding the hole where the sensor holding part can be arranged in a non-contact manner. Can be supported.

The cover is preferably attached to the signal processing unit or the signal processing unit holder through a connection mechanism.

As described above, the cover is attached to the signal processing unit or the signal processing unit holder via the connection mechanism, so that the sensor and the cover are brought into a non-contact state, and the cover is interposed via the signal processing unit or the signal processing unit holder. Can be easily placed on the body surface.

In this case, the signal processing unit holder has a locking unit that locks a puncture device that punctures the sensor into the body, and the cover is engaged by the locking unit as the connection mechanism. It is preferable to have a stop.

In this way, the connection mechanism needs to provide another configuration for attaching the cover to the signal processing unit holder by engaging the locked portion of the cover with the locking portion to which the puncture device is locked. Therefore, the sensor indwelling device can be configured more easily.

Alternatively, the connection mechanism may be configured by a recess formed in the signal processing unit and a projection formed in the cover and fitable in the recess.

Thus, since the connection mechanism is constituted by the concave portion and the convex portion, the cover can be easily attached by fitting the concave portion and the convex portion when the cover is attached. In addition, since the signal processing unit is easily increased in size as compared with a sensor or the like, the recess can be easily formed.

The sensor may include a detection unit inserted into the body, and may be reinforced by a reinforcing member harder than the detection unit and placed in the body.

As described above, since the detection portion of the sensor is reinforced by the reinforcing member, even a flexible detection portion can be easily inserted into the body. In addition, since the reinforcing member is covered with the cover after the placement, even if an external force is applied to the cover, the reinforcing member is not transmitted to the reinforcing member, and the living body can be prevented from being damaged by the reinforcing member.

Furthermore, the sensor can be configured to be connected to the signal processing unit only by a flexible cable on the body surface.

As described above, the sensor and the signal processing unit are connected only by the cable, that is, other parts are not in contact with each other, so that even if an external force is applied to the signal processing unit, the external force is transmitted to the sensor. Can be prevented.

Here, the cover may cover the signal processing unit together with the sensor.

Thus, the cover covers the sensor and the signal processing unit, so that the sensor and the signal processing unit can be integrally protected from external force. Moreover, the beauty | look at the time of visually recognizing a sensor placement device improves from the outside.

In order to achieve the above object, the present invention is a sensor that is placed so that at least a part of the body surface of the measurement target is exposed, and that can detect biological information of the measurement target, and the sensor A sensor indwelling device that includes a signal processing unit that processes a signal including biological information from the sensor, and a puncture device that holds the sensor indwelling device and punctures the sensor into the body of the measurement target In the biological information measurement system, the sensor indwelling device includes a cover that covers the sensor exposed to the body surface in a non-contact state after puncturing the body.

1 is a perspective view showing a part of a blood glucose measurement system according to a first embodiment. It is a perspective view which shows the other part of the blood glucose measurement system of FIG. It is a perspective view which shows the other part of the blood glucose measurement system of FIG. It is a disassembled perspective view which shows the sensor insertion apparatus and sensor placement device of FIG. It is side surface sectional drawing which shows the sensor insertion apparatus of FIG. It is a disassembled perspective view which shows the sensor assembly of the sensor placement device of FIG. 7A is a perspective view illustrating a connection state between the sensor assembly and the pusher in FIG. 4, and FIG. 7B is a side view illustrating a connection state between the sensor assembly and the pusher in FIG. 4. 8A is a first explanatory view showing the relationship between the sensor assembly of FIG. 4 and the base, and FIG. 8B is a second explanatory view showing the relationship between the sensor assembly of FIG. 4 and the base. 9A is a perspective view showing attachment of the transmitter to the sensor insertion device of FIG. 1, and FIG. 9B is a perspective view showing the transmitter of FIG. 9A. 10A is a perspective view showing the cover of FIG. 2, and FIG. 10B is a front sectional view for explaining a connection state of the cover and the base of FIG. 10A. It is the 1st explanatory view explaining the insertion step of the blood glucose measurement system of FIG. It is the 2nd explanatory view explaining the insertion step of the blood glucose measurement system of Drawing 1. It is a 3rd explanatory drawing explaining the insertion step of the blood glucose measurement system of FIG. It is explanatory drawing explaining the state in which the external force was applied to the cover of the blood glucose measurement system of FIG. FIG. 15A is a perspective view showing a sensor indwelling device of the blood sugar measurement system according to the second embodiment, and FIG. 15B is a perspective view for explaining attachment of the cover of FIG. 15A. 16A is a perspective view showing the cover of FIG. 15A, and FIG. 16B is a plan sectional view for explaining a connection state between the cover of FIG. 15A and the transmitter. FIG. 15B is an exploded perspective view showing a sensor assembly of the sensor placement device of FIG. 15B. 18A is a first explanatory diagram showing the relationship between the sensor assembly of FIG. 15B and the base, and FIG. 18B is a second explanatory diagram showing the relationship between the sensor assembly of FIG. 15B and the base. It is explanatory drawing explaining the state in which the external force was applied to the cover of the blood glucose measurement system of FIG. 15A. It is a perspective view which shows a part of blood glucose measurement system which concerns on 3rd Embodiment. FIG. 21 is an exploded perspective view showing a part of a pusher and a sensor assembly arranged inside the sensor insertion device of FIG. 20. 22A is a perspective view showing the pusher of FIG. 21, and FIG. 22B is a perspective view showing the housing of FIG. FIG. 23A is a partial side view showing a state before the sensor insertion of the blood glucose measurement system of FIG. 21, and FIG. 23B is a cross-sectional view showing the state before the sensor insertion. FIG. 24A is a partial side view showing a state where a sensor is inserted from the state shown in FIG. 23A, and FIG. 24B is a cross-sectional view showing a state where the sensor is also inserted. FIG. 25A is a partial side view showing a state where the puncture needle is removed from the state shown in FIG. 23A, and FIG. 25B is a cross-sectional view showing a state where the sensor is similarly removed.

Hereinafter, preferred embodiments (first to third embodiments) of a sensor placement device and a biological information measurement system according to the present invention will be described in detail with reference to the accompanying drawings.

[First Embodiment]
As shown in FIG. 1, the sensor indwelling device 10 according to the first embodiment is a blood glucose measurement system 12 (biological information measurement) used for managing glucose (blood glucose level), which is a blood component of a measurement subject (measurement target). System). In the measurement of glucose, an insertion step of inserting a sensor 14 for detecting glucose into the body of the person to be measured, and a management step of managing blood glucose level information continuously or periodically after the insertion step from the sensor 14 The blood glucose measurement system 12 includes all devices used for each of these steps.

Schematically, the blood glucose measurement system 12 includes a sensor placement device 10, a sensor insertion device 16 (puncture device), a transmitter 24, and a terminal device 18, as shown in FIGS. In the insertion step (see FIG. 1), the transmitter 24 is attached to the sensor indwelling device 10 attached in advance to the sensor insertion device 16. Then, the user (including the subject himself / herself in addition to the doctor and nurse) affixes the base tape 28 at an arbitrary position on the body surface S of the subject to mark the indwelling position of the sensor 14, By grasping and operating the sensor insertion device 16, the sensor 14 of the sensor placement device 10 is inserted into the body of the measurement subject. After this insertion, as shown in FIG. 2, the sensor insertion device 16 is removed from the sensor placement device 10, and the sensor placement device 10 covered with the cover 20 is placed on the body surface S of the measurement subject. In the management step (see FIG. 3), glucose in the measurement subject's blood is detected by the indwelling sensor indwelling device 10, blood glucose level information is transmitted to the terminal device 18, and blood glucose level information is managed by the terminal device 18. I do.

That is, the sensor placement device 10 according to the present invention is placed so that the sensor 14 is inserted into the body of the subject by the sensor insertion device 16 and the other part is exposed on the body surface S of the subject. Thus, the blood sugar level can be measured. Therefore, in order to facilitate understanding of the present invention, the sensor placement device 10 will be described based on the relationship with the sensor insertion device 16.

In the following description, directions of the following description are instructed based on the vertical direction, the front-rear direction, and the left-right direction of the sensor placement device 10 and the sensor insertion device 16 shown in FIG. As will be described later, the sensor 14 moves back and forth (displaces) up and down (displaces) in the sensor insertion device 16, so that the vertical direction may be described as the distal end or the proximal end based on the forward / backward direction. These directions are for convenience of explanation, and it goes without saying that the sensor placement device 10 and the sensor insertion device 16 may be used in any direction.

As shown in FIG. 1, the sensor indwelling device 10 includes a sensor assembly 22, a base 26 (signal processing unit holder), and a base tape 28 (second pasting unit). The sensor indwelling device 10 is held by attaching the base 26 to the lower end side of the sensor insertion device 16 in advance so as to be detachable, whereby the sensor placement device 10 is moved integrally with the sensor insertion device 16. Therefore, the user inserts the sensor insertion device 16 above an appropriate position on the body surface S of the person to be measured (for example, a place where the body movement such as the abdomen or the upper arm is not noticeable and is not conspicuous: the position near the navel or the back of the upper arm). Is positioned and the tip is pressed against the body surface S, the base 26 can be affixed to the base tape 28 previously affixed.

The sensor insertion device 16 is configured as a puncturing device that punctures the sensor 14 of the sensor assembly 22 into the body in a state where the sensor indwelling device 10 is attached to the body surface S of the measurement subject. As shown in FIGS. 4 and 5, the sensor insertion device 16 includes a housing 30, a spring 32, and a pusher 34.

The housing 30 includes a holding portion 36 that holds the base 26 on the distal end (lower end) side, and a cylindrical portion 38 that is provided so as to protrude from the holding portion 36 in the proximal direction (upward). The holding portion 36 is formed wide so as to spread in the front and left-right width directions with respect to the outer shape of the cylindrical portion 38. The cylindrical portion 38 is formed in a rectangular tube shape having a thickness that can accommodate the pusher 34 therein. The housing 30 has a smooth appearance by connecting the holding portion 36 and the cylindrical portion 38 so as to be gently curved.

The holding portion 36 extends downward from the cylindrical portion 38, so that the lower end surface has a sufficiently large area, and the lower surface of the holding portion 36 can cover the front portion of the base 26. A holding space portion 36a corresponding to the shape of the front of the base 26 is notched at the lower portion of the holding portion 36, and the lower surface of the holding portion 36 and the base 26 are in a state where the base 26 is disposed in the holding space portion 36a. The bottom surface of the line is flush with the other (see also FIG. 11).

Furthermore, a pair of

arm portions

40 and 40 projecting a predetermined length in the rear direction are provided at both ends in the width direction of the holding portion 36. The pair of

arm portions

40, 40 are separated from each other at an interval corresponding to the width of the base 26, and have a function of sandwiching the base 26 by inner portions (portions facing each other). As shown in FIG. 5, projections 40 a projecting inward are formed at the rear end portions of the pair of

arm portions

40, 40, and the projections 40 a are used to hold the base 26. .

On the other hand, the cylindrical portion 38 protrudes obliquely at a predetermined angle from the holding portion 36 toward the pair of

arm portions

40, 40, and the corner portion is formed to have a relatively large round corner so that the user can easily grasp it. A hollow portion 42 extending along the axial direction of the tubular portion 38 is formed inside the tubular portion 38, and the pusher 34 and the spring 32 are accommodated in the hollow portion 42. The cavity portion 42 communicates with a hole 38 b formed in the upper side wall portion 38 a of the tubular portion 38 and communicates with a holding space portion 36 a provided in the holding portion 36. The upper side wall part 38a of the cylinder part 38 is formed thicker than the side wall of the cylinder part 38, and the lip 38c constituting the hole part 38b can hook the pusher 34 stably. .

Further, a restricting plate 44 extending along the inclination of the cylindrical portion 38 is formed at the lower front portion of the cylindrical portion 38. A restriction claw 44 a that protrudes inward is provided at the lower part of the restriction plate 44. Further, a cutout portion 46 is formed on the rear side surface of the tubular portion 38 by cutting out a predetermined length upward from the lower holding portion 36. The notch 46 communicates the cavity 42 with the outside and allows the cable 14 b of the sensor assembly 22 held by the pusher 34 to pass therethrough.

As shown in FIG. 4, the pusher 34 accommodated in the hollow portion 42 of the housing 30 (cylinder portion 38) holds the sensor assembly 22 and advances (displaces) in the downward direction. The sensor 14 has a function of puncturing the body of the subject. The pusher 34 includes a sensor mounting portion 48, a trunk portion 50, and an operation portion 52 in order from the lower side to the upper side.

The sensor mounting portion 48 includes a pair of left and right sandwiching

portions

54 and 54 that hold the sensor assembly 22, a pair of left and

right contact portions

56 and 56 formed between the pair of sandwiching

portions

54 and 54, and a pair of sandwiching portions. It has the flange part 58 to which the upper end part of the

parts

54 and 54 and the upper end part of a pair of

contact part

56 and 56 continue (refer also FIG. 7A).

The pair of sandwiching

portions

54, 54 hold the sensor assembly 22 by sandwiching the sandwiched

block portions

68, 68 provided on the left and right sides of the sensor assembly 22. The sandwiching portion 54 includes a front leg portion 54a that protrudes downward from the flange portion 58 and a rear leg portion 54b. The front leg portion 54a and the rear leg portion 54b are formed in the same shape and face each other, and a tapered surface 54c that is inclined inward is formed in the lower part thereof.

The pair of

contact portions

56, 56 protrude downward from the flange portion 58, and are formed in parallel with the sandwiching portion 54 and shorter than the sandwiching portion 54. The lower end surface of the contact portion 56 is a contact surface 56a that is parallel to the lower surface of the holding portion 36 in a state in which the pusher 34 is accommodated in the housing 30, in other words, a contact surface 56a that is not parallel to the lower surface of the flange portion 58 ( (See also FIG. 5). The contact surface 56 a contacts the upper surface of the sensor assembly 22 held by the pusher 34.

The barrel portion 50 is formed in a columnar shape protruding from the central portion of the flange portion 58, and has a branch space 51 that divides the left and right upwards from a substantially middle portion in the axial direction. That is, the trunk portion 50 extends upward from a substantially middle portion in the axial direction as a pair of left and right

branch trunk portions

50a and 50a.

A spring 32 is mounted around the trunk portion 50 when the pusher 34 is accommodated in the housing 30. The spring 32 has a predetermined elastic force and has an inner diameter larger than the outer shapes of the body portion 50 and the operation portion 52. The spring 32 is interposed between the upper side wall portion 38a of the cylindrical portion 38 and the flange portion 58 of the pusher 34, and is in a contracted state when the pusher 34 is positioned upward. As a result, the pusher 34 is given a biasing force pushed downward from the spring 32.

The operation unit 52 is configured as a pair of

operation knobs

52a and 52a connected to upper end portions of the pair of

branch body portions

50a and 50a. The operation knob 52a has a larger cross section than the cross section of the branch body 50a, and forms a step 52b that spreads outward in the radial direction at the connection portion with the branch body 50a. Before the sensor 14 punctures, the pusher 34 stands by while receiving the biasing force (elastic force) from the spring 32 because the step 52b of the operation knob 52a is caught by the mouth edge 38c of the housing 30. When the user operates the pair of operation knobs 52 a and 52 a so as to approach the branch space 51, the step 52 b is detached from the lip 38 c and the pusher 34 moves downward in the housing 30 by the biasing force of the spring 32. . Thereby, the sensor 14 of the sensor assembly 22 held by the pusher 34 is punctured into the body of the measurement subject.

The sensor assembly 22 constitutes a part of the sensor placement device 10 as described above, and is attached to the pusher 34 so that it is displaced integrally with the pusher 34 in the insertion step. After the displacement, it is removed from the pusher 34 and placed on the body surface S of the measurement subject. As shown in FIG. 6, the sensor assembly 22 includes the sensor 14, the reinforcing member 60, the head 62 (sensor holder), and the sensor tape 64 (first pasting portion), and by assembling the members to each other. Constructed into an integral detainment.

Sensor 14 detects information on the glucose concentration (biological information: blood sugar level) contained in the blood component of the measurement subject. As the measurement of the glucose concentration by the sensor 14, a well-known measurement method can be applied. For example, a measurement method using an enzyme that reacts with glucose (enzyme method), or emits fluorescence by binding to glucose (or Measurement method using a fluorescent dye. The sensor 14 inserted by the sensor insertion device 16 is not limited to the sensor 14 that detects the glucose concentration, and various sensors that detect analyte components such as pH, cholesterol, and protein can be applied. .

The sensor 14 includes a detection unit 14a on the distal end side that is inserted into the body of the measurement subject and comes into contact with blood, and a cable 14b that has one end connected to the proximal end side of the detection unit 14a and can transmit a detection signal of the detection unit 14a. And a joining surface portion 14c which is connected to the other end portion of the cable 14b and is formed in a flat surface sufficiently wider than the cable 14b.

The detection unit 14a is an elongated electrode so that it can be easily inserted into the body of the measurement subject. The length of the detection unit 14a depends on the insertion target (blood vessel or biological tissue) or insertion position, but for example, when inserted into the abdomen of the measurement subject, the length may be set to 0.2 to 10 mm. When the detector 14a is inserted into the body, a chemical reaction generates a current proportional to the glucose concentration. This electric current is sent to the joint surface part 14c via the cable 14b.

The joining surface portion 14c is joined so as to be in surface contact with the mold portion 76 provided on the upper surface of the base 26. Since the bonding surface portion 14c is formed in a relatively large planar shape, the bonding force with the mold portion 76 is improved, and the loss of current from the detection portion 14a can be suppressed and transmitted to the mold portion 76. is there.

The cable 14 b is set to a dimension that connects the detection portion 14 a held by the pusher 34 and the joint surface portion 14 c joined to the base 26. The cable 14b has a conductive material inside and the periphery thereof is covered with an insulating material. The cable 14b has a flexible shape that is easily deformable along the short direction of the cross section (the displacement direction of the pusher 34) by forming the cross section of the cable 14b in a rectangular shape. That is, the cable 14b smoothly follows the vertical displacement of the detection unit 14a while the joint surface portion 14c is fixed.

Here, if the cable 14b of the sensor 14 is flexible as described above, it is difficult to puncture the detection unit 14a into the living body. Therefore, the reinforcing member 60 has a function of promoting puncture into the living body by reinforcing the distal end portion of the sensor 14 (the distal end side of the detection portion 14a and the cable 14b). In addition, the sensor 14 is good also as a structure which does not use the reinforcement member 60 by forming the front-end | tip in the shape which is easy to puncture, or giving rigidity.

The reinforcing member 60 includes a linear portion 60a that reinforces the distal end portion of the sensor 14, and a planar portion 60b that continues to the proximal end side of the linear portion 60a. The linear portion 60a has a groove 60c formed along the axial direction of the linear portion 60a, and the leading end side of the detection portion 14a and the cable 14b is accommodated in the groove 60c. The sensor 14 is bonded and fixed so as not to move with respect to the reinforcing member 60 in the accommodated state of the groove 60c. Further, a puncture portion 60d is formed at the tip of the linear portion 60a to protect the detection portion 14a and cover the detection portion 14a so that the detection portion 14a can be detected. The puncture portion 60d has a rigidity and a shape that can be easily punctured into the body of the measurement subject.

The planar portion 60b supports the linear portion 60a at a predetermined inclination angle via a triangular connecting portion 60e. The planar portion 60b is formed in a planar shape (concave shape) along the upper surface (mounting surface 66a) of the head 62, and is disposed so as to overlap the mounting surface 66a and is adhesively fixed to the mounting surface 66a. Is done. This prevents the sensor 14 and the reinforcing member 60 from falling off the head 62. When the sensor assembly 22 is attached to the pusher 34 (see FIG. 11), the contact surface 56a of the pusher 34 comes into contact with the upper surface of the planar portion 60b.

The head 62 includes a sensor support block portion 66 having the mounting surface 66 a and a pair of sandwiched

block portions

68 and 68 connected to both left and right ends of the sensor support block portion 66. The sensor support block 66 has a predetermined thickness and is formed in a concave shape in plan view. The lower surface side of the sensor support block portion 66 is an affixing surface 66b to which the sensor tape 64 is affixed. The mounting surface 66a and the pasting surface 66b are formed flat.

Further, a through hole 66c through which the sensor 14 and the reinforcing member 60 pass is formed near the front side of the sensor support block 66 and in the center in the width direction. The through-hole 66c has a shape corresponding to the shape of the connecting portion 60e of the reinforcing member 60 with a large opening on the mounting surface 66a side and a small opening on the sticking surface 66b side.

The pair of sandwiched

block portions

68 and 68 protrude upward and outward from both ends of the placement surface 66a, respectively, and as described above, are sandwiched between the pair of sandwiching

portions

54 and 54 in the insertion step. The sandwiched block portion 68 is formed in a semicircular shape in a side view, and an arc surface 68a corresponding to the tapered surface 54c of the sandwiching portion 54 is formed on the lower side thereof.

The sensor tape 64 is formed in a substantially semicircular shape larger than the sensor support block portion 66. The sensor tape 64 is a double-sided tape having adhesiveness on the upper and lower surfaces. A hole 64 a that substantially matches the shape of the through hole 66 c on the side of the sticking surface 66 b of the head 62 is formed at the center in the width direction of the sensor tape 64. The sensor tape 64 is affixed to the affixing surface 66b of the head 62 so that the hole 64a overlaps the through hole 66c. In the pasting state, the entire pasting surface 66 b of the head 62 is covered with the sensor tape 64.

As shown in FIG. 4, when assembling the sensor assembly 22, the tip end portion of the sensor 14 is accommodated in the groove 60 c and the puncture portion 60 d of the reinforcing member 60, and the linear portion 60 a of the reinforcing member 60 passes through the head 62. It is inserted into the hole 66 c and the hole 64 a of the sensor tape 64 and protrudes from the lower surface of the sensor tape 64. In a state where the planar portion 60b of the reinforcing member 60 is placed on the placement surface 66a of the head 62, the linear portion 60a protrudes from the lower surface of the sensor tape 64 by a predetermined length, and this protruding portion is formed in the body. When it is inserted into the blood glucose level, it becomes possible to detect the blood sugar level.

7A and 7B, in a state where the sensor assembly 22 is attached to the pusher 34, the pair of sandwiched

block portions

68 and 68 are sandwiched by the pair of sandwiching

portions

54 and 54. Further, the planar portion 60b of the reinforcing member 60 placed on the placement surface 66a of the head 62 comes into contact with the contact surface 56a of the pusher 34, whereby the sensor assembly 22 is fixed. In this state, the tapered surfaces 54c of the pair of sandwiching

portions

54, 54 act to press the sensor assembly 22 toward the pusher 34 (upward), while the contact surfaces 56a of the pair of

contact portions

56, 56 The pressing action in the upward direction is suppressed, and the sensor assembly 22 is held without rattling.

Thus, with respect to the sensor assembly 22 attached to the pusher 34, the base 26 of the sensor placement device 10 is held on the lower surface of the housing 30, as shown in FIG. The base 26 has a function of holding a transmitter 24 that transmits a detection result detected by the sensor 14 to the outside. In particular, the blood glucose measurement system 12 is configured such that the transmitter 24 can be attached to the base 26 before the insertion step (see FIG. 9A).

As shown in FIG. 4, the base 26 has a flat plate shape with a thin plate thickness, and is formed narrower than the width of the lower surface of the housing 30 (holding portion 36). The base 26 includes a front sensor allowing portion 70 formed in a substantially semicircular shape and a rear transmitter arrangement portion 72 formed in a substantially square shape. In the base 26, the front side of the sensor allowing portion 70 and the transmitter arrangement portion 72 is held by the housing 30, and the rear side of the transmitter arrangement portion 72 protrudes from the housing 30.

The sensor allowing portion 70 includes a base-side hole portion 70a that has a large portion of a substantially semicircular flat plate, and an arc-shaped frame 70b that surrounds the base-side hole portion 70a. The base side hole 70a is formed in a semicircular shape larger than the sensor tape 64 (that is, the sensor assembly 22). The head 62 of the sensor assembly 22 enters and is disposed in the base side hole 70a as the pusher 34 is displaced. The arc-shaped frame 70 b constitutes the outer edge of the sensor allowing portion 70 and is accommodated in the holding space portion 36 a when attached to the housing 30.

The transmitter placement portion 72 is connected to the rear portion of the sensor permission portion 70 and is formed in a wider outer shape than the sensor permission portion 70. The transmitter 24 is attached to the upper surface of the transmitter arrangement portion 72. A transmitter attachment portion 72a to which the transmitter 24 is attached is provided at the front side in the width direction center on the upper surface of the transmitter arrangement portion 72. The transmitter mounting portion 72a protrudes from the surrounding flat portion by a predetermined height and is formed in a rectangular shape having rounded corners in plan view. A plurality of metal contacts 72 b are provided on the upper surface of the transmitter mounting portion 72 a, and the metal contacts 72 b are electrically connected to the transmitter 24. An O-ring 74 that is connected to the transmitter 24 is wound around the side peripheral surface portion of the transmitter mounting portion 72a.

A mold portion 76 to which the joining surface portion 14c of the sensor 14 is joined is provided in front of the transmitter mounting portion 72a. The mold part 76 and the metal contact 72 b are electrically connected through the inside of the base 26. For this reason, as shown in FIG. 8A and FIG. 8B, in a state where the joint surface portion 14c of the sensor 14 is joined to the mold portion 76, a state is established in which the detection portion 14a is electrically connected to the metal contact 72b.

Further, a pair of hooking

portions

72c and 72c protruding upward are formed on the left and right sides of the transmitter arrangement portion 72 in the width direction. The pair of

hook portions

72c and 72c are hooked by the

protrusions

40a and 40a formed in the housing 30 in the insertion step, and hooks 86a and 86a formed in the cover 20 are hooked in the management step. Further, a projecting piece 72d for positioning the transmitter 24 is formed at the center in the rearward width direction on the upper surface of the transmitter arrangement portion 72. The bottom surface of the base 26 is a flat pasting surface 72e, and as shown in FIG. 4, the base tape 28 (second pasting portion) is pasted so as to cover the entire pasting surface 72e. It is done.

The base tape 28 is formed in a rectangular shape, and a tape side hole 28a that is similar to the base side hole 70a and slightly smaller than the base side hole 70a is formed at the front side in the width direction. ing. The sensor tape 64 of the sensor assembly 22 is inserted and disposed in the tape side hole 28a as the pusher 34 is displaced.

As shown in FIG. 8A, before the insertion step, the sensor assembly 22 is arranged at a position spaced apart from the holding position of the base 26 by the housing 30 (see FIG. 4) by a pusher 34 (see FIG. 4). Has been. At this time, the cable 14 b of the sensor 14 is in a state of being largely inclined upward due to the bonding surface portion 14 c being bonded to the mold portion 76.

As shown in FIG. 8B, after the insertion step, the sensor assembly 22 enters the base side hole 70a and the tape side hole 28a. At this time, the head 62 and the sensor tape 64 are not in contact with the base 26 and the base tape 28, and only the sensor 14 is connected to the mold portion 76 via the cable 14b. In the cable 14b, the sensor assembly 22 has moved to the same height position as the base 26, so that the connection length to the base 26 has a margin.

As shown in FIGS. 9A and 9B, the transmitter 24 attached to the base 26 has a substantially rectangular case in which the width on the lower surface side coincides with the left and right widths of the base 26 and is gently curved from the lower surface toward the upper surface. 78. The case 78 has a protruding portion 80 that slightly protrudes forward, and the protruding portion 80 covers a part of the mold portion 76 with the case 78 attached to the base 26. Further, on the lower surface of the case 78, a side recess 78a into which the pair of hooking

portions

72c and 72c are inserted and a rear recess 78b into which the protruding piece 72d is inserted are formed.

Inside the case 78, an internal circuit (not shown) for processing the blood sugar level detected by the sensor 14 (detection unit 14a) is provided. As components of the internal circuit, a current-voltage converter that converts the current value detected by the detection unit 14a into a voltage value, an amplifier that amplifies the voltage value, a transmitter that transmits a voltage signal to the outside (wired), a sensor 14 and a battery that supplies power to each device, and a circuit board that electrically connects each device.

A mounting recess 78c attached to the transmitter mounting portion 72a of the base 26 is formed on the front side of the lower surface of the transmitter 24. The mounting recess 78c is formed to a depth corresponding to the protruding height of the transmitter mounting portion 72a, and a metal terminal 78d that contacts the metal contact 72b is provided on the ceiling wall. The metal terminal 78d is electrically connected to an internal circuit in the case 78.

In the transmitter 24, the metal terminal 78d comes into contact with the metal contact 72b with the arrangement (attachment) to the base 26. At this time, the side wall constituting the mounting recess 78c is brought into close contact with the O-ring 74 surrounding the transmitter mounting portion 72a. As a result, the transmitter 24 is prevented from falling off the base 26, and the contact portion between the metal terminal 78d and the metal contact 72b can be kept airtight and liquid tight. The signal processing unit that processes the detection result of the sensor 14 is not limited to the transmitter 24, and various devices can be employed. For example, a monitor device that can directly manage and display blood glucose level information may be applied as the signal processing unit.

After the transmitter 24 is attached to the base 26, the blood glucose measurement system 12 determines the operating state of the sensor 14 by receiving information wirelessly transmitted from the transmitter 24 by the terminal device 18, as shown in FIG. Can do. That is, when a malfunction (sensitivity failure, circuit connection failure, etc.) occurs in the sensor circuit including the detection portion 14a, the cable 14b, and the joint surface portion 14c of the sensor 14, a signal received before and after connection of the transmitter 24 Since no change occurs, it can be determined that there is a step line in the wiring from the sensor 14 to the transmitter 24. Therefore, the abnormality of the sensor 14 can be determined by setting a threshold value in a normal state before the insertion of the sensor 14 in advance and determining whether or not the signal transmitted from the transmitter 24 exceeds the threshold value. .

As the terminal device 18 of the blood glucose measurement system 12, a device capable of wireless communication with the transmitter 24 may be used. For example, a portable device provided with a display panel 18a and operation buttons 18b can be used. The terminal device 18 displays the operation state (normal or abnormal) of the sensor 14 on the display panel 18a based on the operation of the operation button 18b. In addition, after the sensor placement device 10 is placed on the body surface S of the measurement subject, blood glucose level information detected by the sensor 14 is stored (blood glucose level information is stored and displayed on the display panel 18a).

As shown in FIGS. 2 and 3, the sensor indwelling device 10 is configured to attach the cover 20 to the base 26 when it is indwelled by the measurement subject (after the insertion step). The cover 20 is similar to the outer shape of the base 26 and has a slightly larger outer shape than the base 26 so as to be able to surround the outer peripheral edge of the base 26.

The cover 20 has a front sensor protection part 82 formed in a semicircular shape and a rear transmitter protection part 84 formed in a substantially square shape. As shown in FIG. 10A, the sensor protection part 82 has an internal space 82 a constituted by a dome-shaped wall part 82 b, and the internal space 82 a separates the wall part 82 b from the sensor assembly 22 by a predetermined distance. Therefore, even when the cover 20 is attached to the base 26, the wall portion 82 b of the sensor protection portion 82 is not in contact with the sensor assembly 22.

The transmitter protector 84 is connected to the rear part of the sensor protector 82, and has an internal space 84a that can accommodate the transmitter 24 larger than the internal space 82a. The inner surface of the wall portion 84b constituting the internal space 84a is formed so as to substantially follow the outer shape of the transmitter 24, and a slight gap is formed between the upper surface of the transmitter 24 and the cover 20 and the base 26 attached. . That is, since the sensor indwelling device 10 is attached so that the cover 20 is close to the transmitter 24, an increase in size can be suppressed even when the cover 20 is attached.

A pair of

attachment pieces

86 and 86 for attachment to the base 26 are formed in the center portion in the front-rear direction of the transmitter protection portion 84. The attachment piece 86 has an upper end connected to the wall portion 84b on the upper surface of the transmitter protection portion 84, and is curved so as to follow the side wall portion 84b having an arc shape. A hook 86 a that protrudes inward is formed at the lower end of the mounting piece 86, and this hook 86 a constitutes one of the connection mechanisms 88 that connect to the hooking portion 72 c of the base 26.

That is, as shown in FIG. 10B, the connection mechanism 88 constituted by the hook 86a and the hooking portion 72c firmly connects (attaches) the cover 20 to the base 26. Further, an operation protrusion 86b that protrudes outward is formed at the upper end of the attachment piece 86, and the operation protrusion 86b is deformed so that the attachment piece 86 is opened outward by being pressed by the user. To remove the cover 20.

The sensor indwelling device 10 according to the present embodiment is basically configured as described above. Next, regarding the operation of inserting and indwelling the sensor indwelling device 10, the measurement method of the blood glucose measurement system 12 Explain in relation.

When the sensor placement device 10 is placed, the transmitter 24 is set (attached) to the sensor insertion device 16 as shown in FIG. 9A. At this time, as shown in FIG. 11, the sensor assembly 22 is attached to the pusher 34 in advance and is held at a standby position before puncturing. The base 26 has a front portion (front side of the sensor allowing portion 70 and the transmitter placement portion 72) disposed in the holding space portion 36a of the housing 30, and a pair of protrusions 40a of the housing 30 is a pair of hook portions 72c. , 72c. Thereby, the base 26 is attached to the lower surface of the housing 30 and can move integrally with the sensor insertion device 16.

The transmitter 24 is mounted such that the mounting recess 78c fits into the transmitter mounting portion 72a of the base 26. With this attachment, the metal terminal 78d is electrically connected to the metal contact 72b. After the transmitter 24 is set, the terminal device 18 is used as described above to perform an initial test for determining the operation state of the sensor 14.

Then, the user performs the insertion step when the sensor 14 is operating normally. In this case, as shown in FIG. 1, the base tape 28 is affixed to a predetermined position (insertion position) of the abdomen of the measurement subject. Then, after positioning the sensor insertion device 16 above the base tape 28, the base 26 is affixed to the base tape 28.

Next, the user operates the pair of

operation knobs

52a and 52a of the pusher 34 so as to be close to each other. As a result, the stepped portion 52b of the pusher 34 and the lip 38c of the housing 30 are unhooked, and the pusher 34 advances vigorously downward by the urging force of the spring 32. As a result, as shown in FIG. 12, the sensor assembly 22 attached to the tip of the pusher 34 is displaced toward the measurement subject, and the sensor 14 and the reinforcing member 60 are punctured subcutaneously. At this time, since the upper surface of the head 62 (reinforcing member 60) is supported by the contact portion 56, the advance output of the pusher 34 can be reliably transmitted to the sensor assembly 22.

The advancement of the pusher 34 is stopped when the flange portion 58 is caught by the restricting claw portion 44 a of the housing 30. In a state where the advancement of the sensor assembly 22 is stopped, the lower surface of the sensor tape 64 attached to the head 62 is attached to the body surface S of the measurement subject. Here, both the head 62 and the base 26 are located on the body surface S of the measurement subject, but the sensor assembly 22 enters the base side hole 70 a of the base 26 and is in a non-contact state. That is, the sensor assembly 22 is placed on the body surface S of the measurement subject independently of the base 26 (transmitter 24).

After the puncture of the sensor 14, the sensor insertion device 16 is removed from the sensor placement device 10 as shown in FIG. At the time of removal, the sensor assembly 22 is affixed to the body surface S by the sensor tape 64, and the base 26 is affixed to the body surface S by the base tape 28, so that the sensor insertion device 16 is removed. Can be easily performed.

After the sensor insertion device 16 is removed, the cover 20 is attached to the sensor placement device 10 placed on the body surface S as shown in FIG. By pressing the cover 20 from above the sensor placement device 10 in accordance with the shape of the base 26, the pair of

hooks

86a, 86a are just hooked to the pair of

hooks

72c, 72c and can be easily attached. Further, the bottom surface of the cover 20 contacts and adheres to the base tape 28, so that dust can be prevented from entering the cover 20. In addition, the cover 20 is not limited to the structure attached to the base 26, You may affix only by a tape (for example, the tape 28 for bases) simply.

In the management step after the placement of the sensor placement device 10, the sensor 14 detects the glucose concentration of the measurement subject and transmits the detection value to the transmitter 24. Then, the transmitter 24 generates blood glucose level information that can be wirelessly transmitted to the outside as a detection value of the sensor 14, and wirelessly transmits it to the terminal device 18, as shown in FIG. The detection and transmission of the blood glucose level by the sensor indwelling device 10 may be performed continuously (analogly), but may be configured to be performed automatically every predetermined time, for example. Thereby, the power consumption of the transmitter 24 can be significantly reduced. The terminal device 18 stores the received blood glucose level information and displays the stored blood glucose level information in various display forms (graphs, tables, etc.) on the display panel 18a based on the user's operation.

Here, as shown in FIG. 14, when the sensor placement device 10 is covered with the cover 20, an external force is applied to the sensor placement device 10 (for example, an object collides with or clothes contact). However, this external force can be prevented well. In particular, in the sensor placement device 10, the cover 20 is attached to the base 26, and the sensor assembly 22 is placed in a non-contact state with respect to the base 26 and the cover 20. Therefore, even if a physical action such as deformation or vibration occurs on the cover 20 or the base 26 due to an external force applied to the cover 20, the physical action is directly transmitted to the sensor assembly 22. Can be prevented.

Further, the sensor protection portion 82 of the cover 20 covering the sensor assembly 22 is constructed in a state of being closely (fitted) to the frame 70b of the base 26. Thereby, the wall part 82b of the sensor protection part 82 and the sensor 14 are surely brought into a non-contact state, and the cover 20 is supported by the frame 70b, whereby rattling of the cover 20 can be suppressed.

As described above, according to the sensor indwelling device 10 according to the first embodiment, the sensor 14 exposed to the body surface S of the measurement subject can be applied to the sensor 14 exposed to the body surface S of the subject by a simple configuration that includes the cover 20 that covers the sensor 14 without contact. Direct external forces can be prevented at the cover 20. Therefore, the sensor indwelling device 10 stabilizes the sensor 14 by suppressing inconveniences such as the sensor 14 coming off due to an external force, the sensor 14 breaking down, or the person to be measured feels pain or discomfort in the puncture part. Can be used. As a result, it is possible to satisfactorily grasp and manage the biological information acquired by the sensor 14.

In this case, even if the external force is transmitted to the base 26 through the cover 20 because the sensor 14 is held by the head 62 and the head 62 is not in contact with the base 26, the external force is transmitted to the transmitter 24 or There is no direct application from the base 26 to the sensor 14. Therefore, the sensor 14 can be used more stably.

Further, the sensor placement device 10 has a connection mechanism 88 in which the hook 86a of the cover 20 is engaged with the hook portion 72c of the base 26 to which the protrusion portion 40a of the sensor insertion device 16 is hooked. As a result, it is not necessary to provide the base 26 with another configuration for attaching the cover 20, so that the configuration can be simplified. The cover 20 is attached to the base 26 via the connection mechanism 88, so that the cover 20 can be easily placed on the body surface S while the sensor 14 and the cover 20 are not in contact with each other.

Furthermore, since the cover 20 covers the sensor 14 and the transmitter 24, the sensor 14 and the transmitter 24 can be integrally protected from external force. Moreover, this cover 20 can improve the beauty | look at the time of visually recognizing the sensor placement device 10 from the outside.

Furthermore, since the detection portion 14a of the sensor 14 is reinforced by the reinforcing member 60, even the sensor 14 having flexibility can be easily inserted into the body. In addition, since the reinforcing member 60 is covered with the cover 20 after the placement, even if an external force is applied to the cover 20, the reinforcing member 60 is not transmitted to the reinforcing member 60, and the living body can be prevented from being damaged by the reinforcing member 60.

The sensor indwelling device 10 and the blood glucose measurement system 12 (biological information measurement system) according to the present invention are not limited to the above-described embodiments, and can take various forms. For example, in the sensor placement device 10, the sensor assembly 22 and the transmitter 24 are connected only by the cable 14b. However, the present invention is not limited to this, and the sensor placement device 10 in which the sensor 14 and the transmitter 24 (signal processing unit) are integrated. (Not shown). In this case, what is necessary is just to set it as the structure which covers the whole sensor indwelling device by the cover non-contact.

Hereinafter, some other embodiments according to the present invention will be described. In addition, in the following description, the same code | symbol is attached | subjected about the structure same as the sensor placement device 10 which concerns on 1st Embodiment, and the blood glucose measurement system 12, or the structure which has the same function, and it abbreviate | omits about the detailed description. .

[Second Embodiment]
As shown in FIGS. 15A and 15B, the sensor indwelling device 10A (blood glucose measurement system 12A) according to the second embodiment is configured such that the cover 100 covers the entire sensor assembly 102 but not the entire transmitter 104. This is different from the sensor placement device 10 according to the first embodiment.

Specifically, the cover 100 has a substantially rectangular shape with the bottom surface widened toward the end, and two corners on the front side are formed in an R shape (round corner). At the lower part of the cover 100, an outer peripheral frame 106 having a thickness that is continuous with the wall portion 100 a of the cover 100 and coincides with the plate thickness of the base 120 is formed from the front-rear direction intermediate portion to the front. The rear part (transmitter connection part 108) of 100 is in a state of being lifted by the thickness of the base 120.

Inside the cover 100, as shown in FIG. 16A, an inner space 110 that can accommodate the sensor assembly 102 in a non-contact manner is formed by the wall portion 100a and the outer peripheral frame 106. The internal space 110 is narrowed because the wall 100a is curved on the rear side (on the transmitter connecting portion 108 side), and a pair of fitting convex portions is formed from a predetermined position of the wall 100a constituting the transmitter connecting portion 108. 112 and 112 protrude inward. Between the pair of fitting

convex portions

112, 112, an opening 110 a that communicates with the internal space 110 and the rear is formed.

On the other hand, as shown in FIG. 15B, the transmitter 104 to which the cover 100 is attached has the protruding portion 114 protruding larger than the protruding portion 80 according to the first embodiment. The protruding portion 114 covers the entire mold portion 76 in a state where the transmitter 104 is attached to the base 120. Also, a pair of

fitting recesses

116 and 116 that are recessed inward are provided on the left and right side surfaces of the protrusion 114.

That is, the fitting convex portion 112 and the fitting concave portion 116 constitute a connection mechanism 118 that connects the cover 100 and the transmitter 104. As shown in FIG. 16B, when the cover 100 and the transmitter 104 are attached, the pair of fitting

convex portions

112 and 112 are fitted into the pair of fitting

concave portions

116 and 116, so that the transmitter connecting portion 108 and the transmitter of the cover 100 are fitted. 104 protrusions 114 are connected. Thus, the cover 100 is fixed to the transmitter 104 and covers the sensor assembly 102 in front of the transmitter 104. Therefore, since the cover 100 according to the second embodiment can be formed small, the sensor placement device 10A can be downsized.

As shown in FIGS. 15A and 15B, the sensor placement device 10A includes a transmitter placement unit according to the first embodiment, in which the base 120 that holds the transmitter 104 corresponds to the relationship between the cover 100 and the transmitter 104 described above. 72 only. That is, the front end portion of the base 120 is cut at a location that coincides with the front end portion of the transmitter 104 (projecting portion 114). The base 120 also has a transmitter mounting portion 72a, a pair of hooking

portions

72c and 72c, and a protruding piece 72d similar to the base 26 according to the first embodiment.

In addition, the length of the base tape 134 corresponding to the above base 120 is also shortened in the front-rear direction. In front of the base tape 134, a cover tape 122 that is affixed in advance to the outer peripheral frame 106 of the cover 100 is disposed. The cover tape 122 is attached to the body surface S when the cover 100 is attached to the transmitter 104. Thereby, the cover 100 is firmly fixed to the body surface S. The cover tape 122 may be coupled to the base tape 134 and attached to the body surface S together with the base tape 134.

As shown in FIG. 17, the sensor assembly 102 according to the second embodiment includes a sensor 14, a reinforcing member 60, a first head 126, a second head 128, and a sensor tape 130.

The first head 126 includes a sensor support block portion 132 and a pair of sandwiched

block portions

68 and 68 formed at both ends of the sensor support block portion 132. The sensor support block 132 is formed in a concave shape that is longer in the front-rear direction than the head 62 according to the first embodiment in plan view, and has a notch at the front end and each rear end divided into two forks. A groove 136 is formed. The first head 126 is held by the pusher 34 of the sensor insertion device 16 in a state where the sensor 14 and the reinforcing member 60 are arranged. The sensor insertion device 16 can be the same as that of the first embodiment.

Then, the first head 126 advances downward as the pusher 34 is displaced, and punctures the sensor 14 and the reinforcing member 60 (see FIG. 18A). When the first head 126 advances downward, the first head 126 is connected to the second head 128 that is waiting at the lower level of the sensor insertion device 16 (see FIG. 18B).

The second head 128 includes a frame body 138 formed in an annular shape. The frame 138 is enclosed in an annular shape to form a sensor arrangement hole 138a having a space larger than the planar shape of the first head 126. A plurality of (four) locking claws 138b projecting upward are provided on the front and rear sides of the frame 138. The four locking claws 138b are caught in the notch grooves 136 of the first head 126 when the first head 126 is displaced downward. Thereby, the first head 126 and the second head 128 are connected. A sensor tape 130 is attached to the lower surface of the second head 128.

The sensor tape 130 is formed in a planar shape substantially coinciding with the outer peripheral edge of the second head 128. A hole 130 a through which the sensor 14 and the reinforcing member 60 pass is formed in the front center portion of the sensor tape 130. In addition, the sensor tape 130 is arranged with a predetermined gap with respect to the base tape 134, and also with respect to the cover tape 122 arranged so as to surround the periphery when the cover 100 is attached. It is arranged at a position separated by a certain degree.

Hereinafter, the operational effects of the sensor indwelling device 10A (blood glucose measurement system 12A) according to the second embodiment will be described.

As described above, in the sensor placement device 10A, the sensor 14, the reinforcing member 60, and the first head 126 are attached to the sensor attachment portion 48 of the pusher 34 before the insertion step, and the second head 128 and The sensor tape 130 is placed (see FIG. 18A). The second head 128 and the sensor tape 130 are held in the holding space portion 36a of the sensor insertion device 16 with a weak engagement force, and the positioning of the sensor insertion device 16 causes the base 120 and the base tape 134 to be measured together with the measurement subject. Affixed to the body surface S.

When the sensor assembly 102 is displaced downward by the pusher 34 of the sensor insertion device 16, the sensor 14, the reinforcing member 60, the first head 126, and the second head are connected by the connection of the first head 126 and the second head 128. The head 128 and the sensor tape 130 are assembled (integrated) (see FIG. 18B). Since the 1st head 126 is affixed on the upper surface of the sensor tape 130 at the time of displacement, the assembly state of the sensor assembly 102 becomes still stronger. The sensor assembly 102 is placed at a position separated from the transmitter 104 and the base 120, and only the cable 14 b of the sensor 14 is electrically connected to the transmitter 104.

After the insertion step, in the state where the transmitter 104 and the cover 100 are connected and the cover tape 122 is attached to the body surface S, the sensor assembly 102 is covered with the cover 100 as shown in FIG. In this case, the sensor assembly 102 is separated from the cover 100 and the base 120 (non-contact state), and is independently placed on the body surface S of the measurement subject. Therefore, similarly to the sensor placement device 10 according to the first embodiment, even if a physical action occurs due to an external force applied to the cover 100, this physical action is directly transmitted to the sensor assembly 102. Can be prevented. Although there is a possibility that an external force is directly applied to the transmitter 104, the transmitter 104 is covered with the case 78, so that the influence of the external force can be suppressed. The physical action of the transmitter 104 caused by an external force is blocked by the sensor assembly 102 being spaced from the transmitter 104.

Further, in the sensor placement device 10 according to the second embodiment, the connection mechanism 118 is configured by the fitting convex portion 112 and the fitting concave portion 116, so that the fitting convex portion 112 and the fitting concave portion 116 are attached when the cover 100 is attached. By fitting the cover 100, the cover 100 can be easily attached to the transmitter 104. Further, since the transmitter 104 is easily increased in size as compared with the sensor 14 or the like, the fitting recess 116 can be easily formed.

[Third Embodiment]
As shown in FIGS. 20 and 21, the blood glucose measurement system 12 </ b> B according to the third embodiment is the first and second embodiments in that the puncture needle 204 is fixedly held on the pusher 202 of the sensor insertion device 200. This is different from the blood

glucose measurement system

12, 12A according to the above. That is, in the insertion step, the sensor insertion device 200 is configured to puncture the puncture needle 204 together with the sensor 14 into the body of the person to be measured, remove the puncture needle 204 after puncture, and introduce only the sensor 14 into the body. Yes.

The puncture needle 204 has a receiving groove 204 a formed at the tip of the needle with a sharp tip and formed along the axial direction of the puncture needle 204. The accommodation groove 204a accommodates the distal end side of the sensor 14 (the distal end side of the detection portion 14a and the cable 14b) and the linear portion 60a of the reinforcing member 60. Note that the sensor placement device 10A inserted and placed in the blood glucose measurement system 12B according to the third embodiment has the same configuration as the sensor placement device 10A according to the second embodiment.

Further, the pusher 202 is slightly different from the sensor mounting portion 48 according to the first embodiment in the configuration of the sensor mounting portion 206. Specifically, as shown in FIG. 22A, a needle holding portion 208 provided on the front side of the flange portion 58 and a rear side of the flange portion 58 between the pair of sandwiching

portions

54, 54 protruding from the flange portion 58. A pair of abutting

portions

210 and 210 that are provided and press the upper surface of the head 62 (reinforcing member 60) are formed. The puncture needle 204 has its proximal end fixed to the needle holding portion 208, so that when the first head 126 is attached to the sensor attachment portion 206, the distal end portion of the sensor 14 just enters the accommodation groove 204a. Can do.

Also, a pair of removal operation portions 212 formed outward are formed at both left and right end portions of the flange portion 58 of the pusher 202. The removal operation unit 212 is used by the user to directly operate the pusher 202, and enables the puncture needle 204 to be removed after puncturing.

The pair of extraction operation portions 212 is connected to the flange portion 58 and protrudes in a direction orthogonal to the axis of the pusher 202, and is connected to the pair of

rod portions

214 and 214 and has a predetermined size. It has a pair of

operation ear parts

216 and 216 formed in the shape. In the assembled state of the housing 222 and the pusher 202, the rod portion 214 penetrates the guide groove 218 of the cylindrical portion 38 with respect to the flange portion 58 accommodated in the cylindrical portion 38, so that the operation ear portion 216 has the cylindrical portion 38. Exposed outside.

That is, as shown in FIG. 22B, a pair of

guide grooves

218 and 218 corresponding to the above-described extraction operation part 212 are formed on both the left and right side surfaces of the housing 222 (cylinder part 38). The guide groove 218 is formed in a substantially rectangular shape, and is provided so that the longitudinal direction is along the axial direction of the cylindrical portion 38. The upper part of the guide groove 218 is formed wider than the middle part of the guide groove 218, and the inner peripheral edge constituting the groove is provided with a locking piece 220 that protrudes inward and upward. Yes. The guide groove 218 at the location where the locking piece 220 is provided is narrower than the other locations by the locking piece 220.

Hereinafter, the operational effects of the blood glucose measurement system 12B (sensor insertion device 200) according to the third embodiment will be described.

As shown in FIGS. 23A and 23B, the sensor insertion device 200 is configured so that the pusher 202 holding the sensor 14, the reinforcing member 60, and the first head 126 in the housing 222 is puncturable before the sensor 14 is punctured. Waiting. That is, the stepped portion 52 b of the pusher 202 is caught by the mouth edge 38 c of the housing 222, so that the pusher 202 is held at the upper position of the housing 222. In this puncture enabled state, the bar portion 214 of the removal operation portion 212 is at the same height as the protruding portion of the locking piece 220, and the locking piece 220 is pushed and elastically deformed by the bar portion 214. .

As shown in FIGS. 24A and 24B, when the pair of

operation knobs

52a and 52a are operated close to each other from this puncture enabled state, the pusher 202 advances downward by the biasing force of the spring 32. At this time, the bar portion 214 of the removal operation portion 212 moves along the guide groove 218, and the pusher 202 advances stably.

After puncturing, the user operates to hold the pair of

operation ears

216 and 216 and raise the pusher 202. As a result, the pusher 202 is displaced (retracted) upward in the housing 222 as shown in FIGS. 25A and 25B. In the backward movement of the pusher 202, the operation ear 216 is pulled up so that the bar 214 of the extraction operation unit 212 gets over the locking piece 220 above the guide groove 218. As a result, the pair of operation knobs 52 a and 52 a of the pusher 202 are separated from the upper surface of the housing 222, and the end of the locking piece 220 is hooked on the bar portion 214. As a result, the re-advance of the pusher 202 is restricted by the locking piece 220, and the puncture needle 204 is prevented from being exposed on the lower surface of the sensor insertion device 200.

As described above, the blood glucose measurement system 12B according to the third embodiment can surely insert the sensor 14 into the body by the puncture needle 204 of the sensor insertion device 200. Therefore, the sensor 14 and the reinforcing member 60 can be configured with a sufficiently flexible material, and damage of the living tissue due to the sensor 14 and the like after the placement of the sensor placement device 10A can be reduced. In addition, the sensor indwelling device 10A according to the third embodiment does not need to particularly provide the reinforcing member 60, and the tip portion may not be formed sharply as illustrated.

Of course, in the sensor placement device 10A in which the sensor 14 is inserted by the sensor insertion device 200, the external force is directly transmitted to the sensor assembly 102 by attaching the cover 100 at the time of placement, as in the second embodiment. Can be prevented.

It should be noted that the present invention is not limited to the above-described embodiment, and various configurations can be adopted without departing from the gist of the present invention. For example, the measurement target in which the sensor is placed is not limited to the human body, but may be other living organisms (animals, plants, etc.). The biological information acquired by the sensor can be used not only for therapeutic purposes but also for biological research. Furthermore, the sensor indwelling device is not limited to one that is inserted and indwelled by the person to be measured using the sensor insertion device. For example, if the sensor can acquire predetermined biological information from outside the body, the sensor indwelling device May be simply pasted on the body surface S.

Claims

A sensor (14) that is placed so that at least a part of the body surface of the measurement target is exposed and capable of detecting biological information of the measurement target;
A signal processing unit (24, 104) connected to the sensor (14) for processing a signal including biological information from the sensor (14);
A sensor placement device (10, 10A), comprising: a cover (20, 100) that covers the sensor (14) exposed on the body surface in a non-contact state.
The sensor placement device (10, 10A) according to claim 1,
The sensor (14) is held by a sensor holder (62, 126) that is affixed to the body surface via a first affixing part (64, 130),
The signal processing unit (24, 104) is held by a signal processing unit holder (26, 120) attached to the body surface via a second sticking unit (28, 134),
The sensor holding device (10, 10A), wherein the sensor holder (62, 126) and the signal processing unit holder (26, 120) are placed on the body surface without contact with each other.
Sensor indwelling device (10) according to claim 2,
The signal processing unit holder (26) has a hole (70a) in which the sensor holder (62) can be disposed without contact,
The sensor (10), wherein the cover (20) is fitted into a frame (70b) surrounding the hole (70a).
Sensor indwelling device (10, 10A) according to claim 2,
The cover (20, 100) is attached to the signal processing unit (24, 104) or the signal processing unit holder (26, 120) via a connection mechanism (88, 118). Device (10, 10A).
Sensor indwelling device (10) according to claim 4,
The signal processing unit holder (26) has a locking part (72c) to which a puncture device (16) for puncturing the sensor (14) into the body is locked,
The sensor (10), wherein the cover (20) has a locked portion (86a) that engages with the locking portion (72c) as the connection mechanism (88).
In the sensor indwelling device (10A) according to claim 4,
The connection mechanism (118) includes a concave portion (116) formed in the signal processing unit (104) and a convex portion (112) formed in the cover (100) and fitable into the concave portion (116). A sensor indwelling device (10A) characterized by comprising:
The sensor placement device (10, 10A) according to claim 1,
The sensor (14) includes a detection unit (14a) inserted into the body, is reinforced by a reinforcing member (60) harder than the detection unit (14a), and is detained in the body. Sensor indwelling device (10, 10A).
The sensor placement device (10, 10A) according to claim 1,
The sensor (14) is connected to the signal processing unit (24, 104) only by a flexible cable (14b) on the body surface. Sensor indwelling device (10, 10A) ).
Sensor indwelling device (10) according to any one of the preceding claims,
The sensor (10), wherein the cover (20) covers the signal processing unit (24) together with the sensor (14).
The sensor (14) is placed so as to be exposed at least partially on the body surface of the measurement target, and is connected to the sensor (14) capable of detecting the biological information of the measurement target, and the sensor (14). A sensor indwelling device (10, 10A) including a signal processing unit (24, 104) for processing a signal including biological information from
A biological information measurement system (12, 12A, 12B) including a puncture device (16, 200) that holds the sensor indwelling device (10, 10A) and punctures the sensor (14) into the body of the measurement target. And
The sensor indwelling device (10, 10A) includes a cover (20, 100) that covers the sensor (14) exposed to the body surface in a non-contact state after puncturing into the body. Information measurement system (12, 12A, 12B).