WO2019054113A1

WO2019054113A1 - Insertion device and detection device

Info

Publication number: WO2019054113A1
Application number: PCT/JP2018/030128
Authority: WO
Inventors: 秀幸桃木; 保弘小林
Original assignee: テルモ株式会社
Priority date: 2017-09-14
Filing date: 2018-08-10
Publication date: 2019-03-21
Also published as: JPWO2019054113A1; JP7143308B2

Abstract

In the first aspect of the present invention, this insertion device 1 has a base 4 that is held on a body surface 7 throughout a period for detecting biological information while holding a sensor 3 and a needle 2 removed from the body surface 7. In the second aspect of the present invention, this insertion device 1 has a base 4 that is held on the body surface 7 and the base 4 has a base main body 5 and a cover 6 that is held by the base main body 5 so as to be slidable in a first direction D1 extending from the outside to the inside of the base main body 5. The base 4 further has a spring 12 for urging the needle 2 in the first direction D1. A detection device 9 has the insertion device 1 and a processing device 8.

Description

Insertion device and detection device

The present disclosure relates to an insertion device and a detection device.

For example, as an insertion device used for the purpose of measuring a blood glucose level, as described in, for example, Patent Document 1, one having a needle to be punctured in the body surface and a sensor to be inserted below the body surface by the needle Are known. Patent Document 1 also describes a processing device that is detachably mounted to the insertion device. The insertion device and the processing device constitute a detection device.

Patent No. 4870075

The insertion device as described in Patent Document 1 has an attachment unit which is held on the body surface in a state of holding a sensor inserted below the body surface, and a needle which is held immediately after removal of the needle. And an applicator to be removed. With such a configuration, it takes time to separately dispose the mounting unit and the applicator.

In view of such a point, the present disclosure has a first object to provide an insertion device and a detection device capable of reducing the time and effort for disposal.

Also, an insertion device such as described in U.S. Pat. No. 5,985,099 includes a conduit assembly that is manually pulled back for needle removal. However, it is convenient if the needle can be removed more easily.

In view of the foregoing, it is a second object of the present disclosure to provide an insertion device and a detection device capable of easily removing a needle.

The insertion device as a first aspect of the present invention is
A needle to be punctured on the body surface,
A sensor inserted below the body surface by the needle and outputting a signal according to biological information;
A base held on the body surface in a state of holding the sensor and the needle removed from the body surface over a detection period of the biological information based on the signal.

In one embodiment of the present invention, the base is in contact with the first surface that contacts the body surface when the needle is punctured into the body surface, and contacts the body surface when the needle is punctured into the body surface. And a second surface in contact with the body surface over the detection period.

In one embodiment of the invention:
The base has a sticking member to be stuck to the body surface,
The sticking member has a first sticking portion having the first surface, and a second sticking portion continuous with the first sticking portion via a hinge portion and having the second surface.

In one embodiment of the invention:
The base includes a base body, and a cover slidably held by the base body in a first direction from the outside to the inside of the base body.
The base body can temporarily hold the needle in a puncturing position that protrudes from the base body,
The cover is slidable in the first direction from a covering position covering the projection of the needle in a state where the needle is held at the puncture position.

In one embodiment of the present invention, the base includes a spring for biasing the needle in the first direction.

In one embodiment of the present invention, the spring biases the cover in a second direction opposite to the first direction.

The insertion device as the second aspect of the present invention is
A needle to be punctured on the body surface,
A sensor inserted below the body surface by the needle and outputting a signal according to biological information below the body surface;
And a base held on the body surface,
The base includes a base body, and a cover slidably held by the base body in a first direction from the outside to the inside of the base body.
The base body can temporarily hold the needle in a puncturing position that protrudes from the base body,
The cover is slidable in the first direction from a covering position covering the protrusion of the needle in a state in which the needle is held at the puncture position.
The base further comprises a spring biasing the needle in the first direction.

In one embodiment of the invention:
The base main body has a needle holding portion that holds the needle in the puncturing position by engaging with the needle.
The needle holding portion is released from the engagement with the needle by being pressed by the cover moved in the first direction.

In one embodiment of the present invention, the sensor is an electrochemical sensor.

The detection device as one aspect of the present invention is
The insertion device;
And a processing device which is detachably mounted to the insertion device and processes the signal to obtain data regarding the biological information.

According to the present disclosure (in particular, the insertion device according to the first aspect of the present invention), it is possible to provide an insertion device and a detection device capable of reducing the time and effort for disposal.

According to the present disclosure (in particular, the insertion device according to the second aspect of the present invention), it is possible to provide an insertion device and a detection device capable of easily removing the needle.

It is a perspective view showing the insertion device concerning one embodiment of the present invention. It is a perspective view showing an insertion device, omitting a lid. It is a front view showing an insertion device, omitting a lid. It is AA sectional drawing of FIG. 3A. It is a figure explaining the operation procedure of an insertion apparatus, and shows an insertion apparatus when making it contact with the body surface (illustration of a lid is abbreviate | omitted). It is a figure explaining the operation procedure of an insertion apparatus, and shows an insertion apparatus when pressing an insertion apparatus on the body surface from the state of FIG. 4, and puncturing a needle on the body surface (illustration of a lid is abbreviate | omitted). It is a figure explaining the operation procedure of an insertion apparatus, and shows an insertion apparatus when puncture of a needle is completed from the state of FIG. 5, and a needle is removed from the body surface (illustration of a lid is abbreviate | omitted). It is a figure explaining the operation procedure of an insertion apparatus, and shows an insertion apparatus when tilting an insertion apparatus from the state of FIG. 6, and holding on a body surface (illustration of a lid is abbreviate | omitted). It is a figure explaining the operation procedure of an insertion apparatus, and shows the insertion apparatus at the time of attaching a processing apparatus in the state of FIG. It is a figure explaining the operation procedure of an insertion apparatus, and a processing apparatus is attached to an insertion apparatus from the state of FIG. 8, and the detection apparatus when detection of biometric information is started is shown.

Hereinafter, an insertion device and a detection device according to an embodiment of the present invention will be exemplarily described in detail with reference to FIGS. 1 to 9. As used herein, the front of the insertion device means the upper surface seen in a state where the insertion device is turned down and held on the body surface after withdrawal of the needle. The back side of the insertion device means the side opposite to the front side (the lower side in contact with the body surface in the above state).

As shown in FIGS. 1 and 2, the insertion device 1 according to the present embodiment includes a needle 2, a sensor 3, and a base 4. In the present embodiment, the base 4 has a base body 5 and a cover 6. The base body 5 has a housing 5a and a lid 5b (see FIG. 1). The needle 2 punctures the body surface 7 of a living body (for example, a human body) (see FIG. 5). The sensor 3 is inserted under the body surface 7 together with the needle 2 and then detained under the body surface 7 by removing only the needle 2 (see FIGS. 5 and 6). The sensor 3 is configured to be able to output a signal according to biological information by being indwelled subcutaneously. The biological information is, in the present embodiment, the glucose concentration in the interstitial fluid. The glucose concentration in the interstitial fluid reflects the blood glucose level. However, the biological information may be a concentration such as lactic acid or a pulse. In the present embodiment, since the sensor 3 is an electrochemical sensor, the signal is an electrical signal (current or voltage). The sensor 3 is not limited to the electrochemical sensor, and may be, for example, an optical sensor that outputs an optical signal (fluorescence) as the signal.

In the present embodiment, as shown in FIGS. 8 and 9, the processing device 8 is detachably attached to the insertion device 1. The processing device 8 is detachably attached to the insertion device 1 and is configured to process the signal to obtain data on biological information. The insertion device 1 and the processing device 8 constitute a detection device 9 according to the present embodiment. In the present embodiment, the processing device 8 is configured as a transmitter that wirelessly transmits the obtained data to an external device. In the present embodiment, the processing device 8 is connected to a contact connected to the contact 10 of the sensor 3 and to the contact via an A / D converter, and the signal processing is performed to obtain the data related to the biological information. And a wireless transmission / reception module for wirelessly transmitting data obtained by the signal processing unit to an external device (not shown). Furthermore, the processing device 8 has a central processing unit (CPU), a memory, a battery (a primary battery or a secondary battery may be used), and the like in order to control the signal processing unit and the wireless transmission / reception module. The external device may be a stationary terminal such as a desktop computer, or may be a portable terminal such as a smartphone, a tablet, or a laptop computer. In the present embodiment, the external device includes a wireless transmission / reception module that wirelessly receives data transmitted by the processing device 8, and a biological information calculation unit that calculates biological information (blood sugar level) based on the received data. . Furthermore, in order to control the wireless transmission / reception module and the biological information calculation unit, the external device may be a central processing unit (CPU), a memory, a power supply unit (outlet and / or battery). Etc.). In the present embodiment, the external device also has an interface such as an input unit, a display unit, and a speaker. The configurations of the processing device 8 and the external device can be changed as appropriate. In the present embodiment, a continuous glucose monitoring (CGM) system is configured by the detection device 9 and the external device. The processing device 8 may not be a transmitter that wirelessly transmits data related to biological information. For example, the processing device 8 may be configured to transmit data by wire to an external device, or may be configured to provide the external device via a recording medium such as a memory card. The processing device 8 may be configured to process the signal to calculate biological information, and to notify the user of the biological information via an interface such as a built-in display.

As shown in FIGS. 7 to 9, in the present embodiment, the base 4 of the insertion device 1 holds the sensor 3 and the needle 2 removed from the body surface 7 over the detection period of the biological information based on the signal. It is configured to be held on the body surface 7 in the state. Therefore, at the end of the detection period of the biological information, the insertion device 1 can be discarded while the processing device 8 can be reused for the next detection. As described above, according to the present embodiment, since the member including the used needle 2 and the sensor 3 can be discarded at one time by discarding the insertion device 1, the time and effort for disposal can be reduced. However, the insertion device 1 is not limited to such a configuration. For example, after removal of the needle 2, only the needle 2 and the sensor 3 may be removed from the base 4 and discarded first. The detection period of biological information is appropriately determined by the judgment of a doctor or the like for several hours, several days, one week, one month, and the like.

As shown in FIGS. 6 and 7, in the present embodiment, the rectangular base 4 is turned over so that the base 2 is held on the body surface 7 after the needle 2 is withdrawn from the body surface 7. Is made possible. As shown to FIG. 3B, the base 4 is provided with the 1st surface 4a and the 2nd surface 4b, and the surface (surface to be stuck) in alignment with skin differs at the time of puncture and detection. In other words, the position of the base 4 with respect to the body surface 7 (the angle between the body surface 7 and the plane parallel to the puncture direction of the base 4) differs between the time of puncture and the time of detection. The first surface 4 a is configured to contact the body surface 7 when the needle 2 is punctured into the body surface 7. The second surface 4 b is not in contact with the body surface 7 when the needle 2 punctures the body surface 7. The second surface 4 b is configured to be in contact with the body surface 7 for a detection period. More specifically, the base 4 has an attaching member 11 attached to the body surface 7. As shown in FIG. 7, the sticking member 11 is connected to the first sticking part 11 a having the first face 4 a and the first sticking part 11 a through the hinge part (bent part) 11 b and the second face 4 b. And the second pasting portion 11c. The first attaching part 11a (and the first surface 4a) is disposed along a plane orthogonal to the axial center X of the needle 2 (see FIGS. 3A and 3B) when the needle 2 punctures. The sticking member 11 is attached to the base body 5. The first attaching part 11 a is attached to the base main body 5 in a removable manner. More specifically, the adhesion of the first sticking part 11 a to the base body 5 is smaller than the adhesion of the first sticking part 11 a to the body surface 7. The second attaching part 11 c is fixed to the base main body 5. As shown in FIG. 6, the first surface 4a of the first sticking portion 11a is a body by bringing the first surface 4a of the first sticking portion 11a into contact with the body surface 7 during the puncturing removal operation of the needle 2. It is stuck on the surface 7. Therefore, the insertion device 1 can be temporarily fixed (positioned) to the body surface 7 by sticking the first surface 4 a to the body surface. Thereby, the operation at the time of puncture removal can be stabilized. Thereafter, as shown in FIG. 7, the second attachment portion 11c is rotated through the hinge portion 11b by tilting the base main body 5 toward the body surface 7 with the hinge portion 11b (bent portion) as a fulcrum. Let The base 4 is pivoted (moved) to a position along the body surface 7, and the second attaching part 11 c (second surface 4 b) of the base 4 is attached to the body surface 7. In other words, the base 4 has a configuration in which the base 4 follows (contacts) the skin in different planes at the time of puncturing removal and detection of the needle 2. In the present embodiment, the case where the puncture is performed almost perpendicularly to the body surface 7 is shown, but the needle 2 and the sensor 3 can be arbitrarily selected for the body surface 7 according to the characteristics of the sensor 3 and detection reagent to be applied. It may be configured to puncture at an angle. In this case, the contact surface 6c in contact with the body surface of the cover 6 may be inclined so that the first surface 4a has a predetermined puncture angle. A liner for protecting the adhesive material on the sticking surface may be provided on the sticking surface of the sticking member 11, and the liner may be peeled off at a desired timing. According to such a configuration, the height of protrusion of the insertion device 1 and the detection device 9 from the body surface 7 at the time of detection of biological information can be reduced (for example, the height of protrusion can be within 1 cm), and the wearing feeling and safety I can improve the nature. Moreover, according to such a configuration, it is possible to use the needle 2 having a normal closed cross-sectional shape without using a needle having a special shape such as a C-shaped cross section or a V-shaped cross section. Even when the needle 2 of the closed cross-sectional shape is used, the frequency of occurrence of the contact failure can be reduced because a dedicated part for connecting the sensor 3 and the contact 10 and an operation step for such connection are not necessary. . In this embodiment, since the needle 2 having a normal closed cross-sectional shape is used, the sensor 3 can be stably disposed below the body surface 7. The first attaching part 11a and the second attaching part 11c may be configured as separate members, and these members may be connected via a hinge member as a hinge part. Further, the second attaching part 11c and the base main body 5 may be configured to be detachable. In this case, it is preferable that the adhesion of the second attaching part 11c to the base main body 5 be larger than the adhesion of the second attaching part 11c to the body surface 7. However, the insertion device 1 is not limited to such a configuration. For example, the base 4 may be configured to be held on the body surface 7 without using the pasting member 11 as described above. The second attaching part 11c may be fixed to the base main body 5 via a rigid locking member. When the needle 2 is punctured into the body surface 7, the first attaching part 11a and the second attaching part 11c are attached to the body surface 7, and thereafter, the body surface 7 with the base body 5 as a fulcrum of the hinge part 11b. It may be made to be fixed on the 2nd sticking part 11c via a locking member, when it falls to the side.

As shown in FIGS. 4 to 6, in the present embodiment, the cover 6 is slidably held by the base body 5 in the first direction D1 from the outside to the inside of the base body 5. In the present embodiment, the first direction D1 is a direction (needle removal direction) from the outside to the inside of the base body 5 along the axial center X of the needle 2. However, the first direction D1 may not be the direction along the axial center X of the needle 2. In the present embodiment, while the hub 2b is held by the needle holding portion 13 described later, the base body 5 temporarily holds the needle 2 in a puncturing position (position shown in FIGS. 4 and 5) for projecting the needle 2 from the base body 5. Can be held. The cover 6 is slidable in the first direction D1, as shown in FIG. 5, from the covering position (the position shown in FIG. 4) covering the projection of the needle 2 in the state where the needle 2 is held in the puncturing position. is there. That is, only the cover 6 moves relative to the needle 2 in the first direction D1 while the needle 2 is kept at the puncture position. Thereby, only the needle 2 and the sensor 3 are inserted into the living body. An engagement portion that is released when a force exceeding a predetermined amount is applied to the cover 6 in the first direction D1 may be provided between the cover 6 and the base main body 5. According to such a configuration, exposure of the needle 2 can be prevented by the cover 6, and safety at the time of operation of the insertion device 1 can be improved. However, the insertion device 1 is not limited to such a configuration. That is, the insertion device 1 may not have the cover 6 as described above.

As shown in FIG. 5, in the present embodiment, the base 4 includes a spring 12 that biases the needle 2 in the first direction D1. The spring 12 biases the needle 2 in the first direction D1 by an elastic force generated by moving the cover 6 in the first direction D1. According to such a configuration, a biasing force for removing the needle 2 can be generated by the puncturing operation. Thus, the use of such a spring 12 simplifies the construction. However, the insertion device 1 is not limited to such a configuration. That is, the insertion device 1 may not have the spring 12 as described above. For example, the needle 2 may be manually removed without such a biasing force.

As shown in FIGS. 4 and 5, in the initial state of the present embodiment, the spring 12 is configured to bias the cover 6 in a second direction D2 (puncture insertion direction) opposite to the first direction D1. It is done. According to such a configuration, the exposure of the needle 2 can be stably prevented. From this viewpoint, it is preferable that the spring 12 bias the cover 6 in the second direction D2 with the cover 6 in the covering position. However, the spring 12 may not be configured to bias the cover 6 in the second direction D2.

As shown to FIG. 2, FIG. 3A, the base main body 5 has the needle | hook holding part (latch) 13 which hold | maintains the needle 2 in a puncture position by engaging with the needle 2. As shown in FIG. The needle holding portion 13 is configured to be opened (see FIGS. 5 and 6) by being pressed by the cover 6 moved in the first direction D1, and to release the engagement with the needle 2. According to such a configuration, the cover 6 is moved and the engagement of the needle holding portion 13 is released only by the operation of pressing the base main body 5 toward the body surface 7, and the temporary movement of the needle 2 to the puncturing position is performed. The operability can be improved because such a holding state can be eliminated. However, the insertion device 1 is not limited to such a configuration. For example, the disengagement of the needle holder 13 may be performed manually separately from the movement of the cover 6.

In the present embodiment, as shown in FIGS. 3A and 3B, the needle 2 has a needle body 2a having an axial center X and a hub 2b connected to the proximal end of the needle body 2a. The needle main body 2a has a long cylindrical shape and has a blade surface at its tip. The needle body 2a may be made of steel (e.g. stainless steel). The hub 2 b has concave portions 14 on both side surfaces that engage with the needle holding portion 13. Inside the needle 2, a hollow portion penetrating from the tip of the needle body 2a to the proximal end of the hub 2b is formed. However, the needle 2 is not limited to such a configuration.

In the present embodiment, as shown in FIGS. 3A and 3B, the sensor 3 includes two

electrodes

3a and 3b each including a working electrode and a counter electrode. Each of the

electrodes

3a and 3b has a detection reagent (a glucose oxidase enzyme or a variant thereof, a glucose binding substance, or the like) that reacts with glucose at a contact portion with body fluid below the body surface 7. Any detection reagent may be used as long as it can quantitatively detect glucose, and a detection method according to the detection reagent can be applied. At the proximal end of each

electrode

3a, 3b, an

electrical contact

15a, 15b connected to the processing device 8 is provided. The contact 10 of the sensor 3 consists of two

electrical contacts

15a, 15b. The sensor 3 is disposed in the hollow portion of the needle 2. The sensor 3 extends beyond the proximal end of the needle 2 to the

electrical contacts

15a, 15b. The needle 2 holds the sensor 3 inside the needle 2 from the puncturing operation to the removal (in use). Before puncturing (in the initial state), the needle 2 is located at the most distal end of the sensor 3, but at the time of removal (in use), it is located on the proximal side of the initial state. As a configuration of the sensor 3, for example, the sensor 3 may be configured by three electrodes in which a reference electrode is also added to a working electrode and a counter electrode. In this case, the number of contacts 10 is also three. The sensor 3 may be configured as an optical sensor. In this case, the sensor 3 may have a light guide such as an optical fiber. The light guide may have a phosphor that generates fluorescence according to biological information by excitation light from the light guide at a contact portion with body fluid below the body surface 7. The contact 10 is an optical contact.

In the present embodiment, (the housing 5a of) the base body 5 has a through hole 16 which allows the cover 6 to slide along the axial center X of the needle 2 as shown in FIGS. 3A and 3B. There is. The base body 5 (the housing 5 a thereof) has a pair of needle holding pieces 13 a that constitute the needle holding portion 13. The needle holding portion 13 includes a pair of needle holding pieces 13a. On the inner side surfaces of the pair of needle holding pieces 13a, convex portions 17 are provided which engage with the concave portions 14 provided on both side surfaces of the hub 2b. Each of the pair of needle holding pieces 13a extends along the axial center X of the needle 2 and has a cantilever shape in which the end in the second direction D2 is a free end. As shown in FIG. 6, the tips of the inner side surfaces of the pair of needle holding pieces 13a are pushed by the cover 6 when the puncturing of the needle 2 is completed, and the free ends of the pair of needle holding pieces 13a open (that is, the pair The free ends of the needle holding pieces 13a move away from each other) and are disengaged from the hub 2b. In the vicinity of the fixed ends of the pair of needle holding pieces 13a, notches 18 for adjusting (reducing) the rigidity are provided. A pair of guide walls 19 extending along the axial center X of the needle 2 is connected to the fixed end of the pair of needle holding pieces 13a. When the engagement between the needle 2 and the needle holding portion 13 is released, the urging force of the spring 12 moves the needle 2 along the pair of guide walls 19 in the first direction D1. At this time, both side surfaces of the hub 2 b are guided by the pair of guide walls 19. As shown in FIGS. 6 and 7, the cover 6 engages with the cover 6 in the second direction D2 of the pair of needle holding pieces 13a when the engagement between the needle holding portion 13 and the needle 2 is released. A cover holding portion 20 is provided which prevents the sliding in the second direction D2 again. The cover holding portion 20 is composed of a pair of cover holding pieces 20a. Each of the pair of cover holding pieces 20a has a cantilever shape in which the end in the first direction D1 is a free end. The pair of cover holding pieces 20a is elastically deformed by the cover 6 when the cover 6 slides in the first direction D1, and gets over the cover 6 to engage the cover 6 with the free ends of the pair of cover holding pieces 20a. , Thereby preventing the cover 6 from sliding in the second direction D2. The cover holding piece 20a may be a protrusion having an inclined surface that gradually increases in the first direction D1. However, the base body 5 is not limited to such a configuration.

In the present embodiment, as shown in FIGS. 3A, 3B, 6, and 7, the cover 6 has a cylindrical shape, and has a hollow portion through which the needle body 2a passes. The cover 6 has a covering portion 6a (see FIG. 3B) which covers the protrusion of the needle 2 (the protrusion from the base main body 5) when the needle 2 is in the puncturing position. The covering portion 6 a covers the protruding portion of the needle 2 to prevent the user from contacting the blade surface of the needle 2. Inside the cover 6 is provided a seating surface 21 for receiving an end of the spring 12 in the second direction D2. At the end of the cover 6 in the first direction D1, a pair of engaging portions 6b (see FIG. 6) formed of a pair of convex portions are provided. The pair of engaging portions 6b can open the free end by engaging with the free ends of the pair of needle holding pieces 13a. Furthermore, the pair of engaging portions 6b can prevent the cover 6 from sliding in the second direction D2 by engaging with the pair of cover holding pieces 20a. The cover 6 is flush with the surface of the base main body 5 as shown in FIG. 6 when the puncture of the needle 2 is completed, and the surface of the base main body 5 (the sticking surface of the first sticking portion 11 a) It is configured to contact the. However, the cover 6 is not limited to such a configuration.

In the present embodiment, the spring 12 is configured as a coil spring as shown in FIGS. 4 to 6. An end of the spring 12 in the second direction D2 is received on a seat 21 provided on the cover 6. The end of the spring 12 in the first direction D1 is received by a seating surface 22 provided on the hub 2b. The spring 12 compresses the compressive force between the cover 6 and the hub 2b as the cover 6 moves in the first direction D1 (moves into the base body 5) in the direction of withdrawal from the living body. As a biasing force. However, the spring 12 is not limited to such a configuration.

In the present embodiment, as shown in FIG. 8 and FIG. 9, the base 4 has a pair of operation pieces 23 for facilitating attachment and detachment with the processing apparatus 8. The pair of operation pieces 23 are provided on both sides of the base body 5 and each has a cantilever shape. The free end of the pair of operation pieces 23 is provided with a holding portion 23 a that engages with the processing device 8 and holds the processing device 8. The holding portion 23a is a convex portion provided on the outer side surface of the pair of operation pieces 23, and the processing device 8 is formed with an opening that engages with the convex portion. However, the configuration of the holding unit 23a can be changed as appropriate. For example, the holding portion 23 a may be configured as an opening, and the processing device 8 may be provided with a convex portion. When the holder 23 a engages with the processing device 8, the contact point of the processing device 8 is connected to the contact point 10 of the sensor 3. The pair of operation pieces 23 each have an operation portion 23 b provided with a plurality of ribs. By pressing the operation portions 23b of the pair of operation pieces 23 so as to approach each other, the engagement between the pair of holding portions 23a and the processing device 8 can be released, and the processing device 8 can be removed from the insertion device 1. However, the base 4 is not limited to such a configuration.

In order to use the insertion device 1 according to the present embodiment, first, as shown in FIG. 4 and FIG. 5, the cover 6 is pressed against the body surface 7 to resist the biasing force of the spring 12 and the base main body. Press 5 towards body surface 7. By this pressing, the cover 6 slides relative to the base main body 5 in the first direction D1, the base main body 5 approaches the body surface 7, and the needle 2 held at the puncturing position punctures the body surface 7. At this time, the biasing force of the spring 12 is increased. As shown in FIG. 6, when the engagement between the needle holding portion 13 and the needle 2 is released by the cover 6 sliding in the first direction D1, the needle 2 automatically makes the body by the urging force of the spring 12 which is increased. The hub 2 b is removed from the surface 7 and moved and fixed to the locking end 24 (see FIG. 3A, FIG. 3B) and is housed inside the base 4. At this time, the cover 6 is fixed to the base main body 5 by the engagement portion 6 b being held between the needle holding portion 13 and the cover holding portion 20. When the cover 6 is fixed to the cover holding portion 20, the spring 12 is held between the cover 6 (seating surface 21) and the hub 2b (seating surface 22). By fixing and locking the cover 6 to the cover holding portion 20, the hub 2b is prevented from moving again in the second direction D2, so the used needle 2 is not exposed from the base 4. Then, as shown in FIG. 7, the base 4 is held on the body surface 7 by tilting the base 4. As described above, the needle 2 is housed inside the base 4 (the cover 6 and the base body 5) through the front and back of the puncturing of the needle 2, so that the safety is secured. Thus, the user can perform the sensor insertion operation only by holding the base body 5 and pressing the tip of the cover 6 against the body surface 7. Furthermore, even if it is necessary to start using the detection device 9 outside the house, needle waste is not generated at the start of use of the detection device 9 (there is no need to discard the needle alone), so carry a dedicated waste container. There is no need. In addition, since the needle 2 after puncturing is housed inside the base 4 at a position along the body surface 7 while the detection device 9 is attached, thinning of the device is possible. Then, as shown in FIG. 8 and FIG. 9, by attaching the processing device 8 to the insertion device 1, detection of biological information is started. When the biological information detection period ends, the processing device 8 is removed from the insertion device 1, and the insertion device 1 is removed from the body surface 7. Then, the insertion device 1 is discarded, and the processing device 8 is reused together with the new insertion device 1 for the next detection.

It goes without saying that the present embodiment described above is merely an example of the embodiment of the present invention, and various changes can be made without departing from the scope of the invention.

DESCRIPTION OF SYMBOLS 1 insertion device 2 needle 2a needle main body 2b hub 3

sensor

3a, 3b electrode 4 base 4a first surface 4b second surface 5 base main body 5a housing 5b lid 6 cover

6a covering portion

6b engaging portion 6c contact surface 7 body surface 8 Processing device 9 detection device 10 contact point 11 sticking member 11a first sticking portion 11b hinge portion 11c second sticking portion 12 spring 13 needle holding portion 13a needle holding piece 14

concave portion

15a, 15b electrical contact 16 through hole 17 convex portion 18 notch 19 guide wall 20 cover holding portion 20a

cover holding piece

21, 22 seat surface 23 operation piece

23a holding portion

23b operation portion 24 locking end X axis D1 first direction D2 second direction

Claims

A needle to be punctured on the body surface,
A sensor inserted below the body surface by the needle and outputting a signal according to biological information;
An insertion device comprising: a base held on the body surface in a state of holding the sensor and the needle removed from the body surface over a detection period of the biological information based on the signal.
The base is a first surface in contact with the body surface when the needle is punctured in the body surface, and not in contact with the body surface when the needle is punctured in the body surface, the body for the detection period. The insertion device according to claim 1, further comprising: a second surface in contact with the surface.
The base has a sticking member to be stuck to the body surface,
The said sticking member has a 1st sticking part which has the said 1st surface, and a 2nd sticking part which continues in a row with the said 1st sticking part via a hinge part, and has the said 2nd surface, Insertion device.
The base includes a base body, and a cover slidably held by the base body in a first direction from the outside to the inside of the base body.
The base body can temporarily hold the needle in a puncturing position that protrudes from the base body,
The said cover is slidable in the said 1st direction from the covering position which covers the protrusion part of the said needle in the state in which the said needle was hold | maintained at the said puncturing position. Insertion device.
5. The insertion device according to claim 4, wherein the base comprises a spring biasing the needle in the first direction.
The insertion device according to claim 5, wherein the spring biases the cover in a second direction opposite to the first direction.
A needle to be punctured on the body surface,
A sensor inserted below the body surface by the needle and outputting a signal according to biological information below the body surface;
And a base held on the body surface,
The base includes a base body, and a cover slidably held by the base body in a first direction from the outside to the inside of the base body.
The base body can temporarily hold the needle in a puncturing position that protrudes from the base body,
The cover is slidable in the first direction from a covering position covering the protrusion of the needle in a state in which the needle is held at the puncture position.
The insertion device, wherein the base further comprises a spring biasing the needle in the first direction.
The base main body has a needle holding portion that holds the needle in the puncturing position by engaging with the needle.
The insertion device according to any one of claims 4 to 7, wherein the needle holding portion is released from the engagement with the needle by being pressed by the cover moved in the first direction.
The insertion device according to any one of claims 4 to 8, wherein the sensor is an electrochemical sensor.
An insertion device according to any one of the preceding claims.
A detection device, which is detachably mounted on the insertion device and which processes the signal to obtain data on the biological information.