JP7532236B2 - Syringes and administration devices - Google Patents

Description

The present invention relates to a needleless syringe for injecting a medicinal liquid into a subject, and a management device for managing injections using this syringe.

Diabetic patients are given a diabetes therapy in which they inject themselves with medicinal liquids such as insulin using a special syringe, and the patient self-controls their blood glucose levels. In addition to the syringes shown in Patent Document 1 below, there have been various other types of syringes used in this therapy, many of which have extremely thin needles, and the patient purchases and stores (stores in the refrigerator) injectable drugs contained in containers called vitals (5 ml, 10 ml, etc.) based on a prescription, and when injecting, the patient fills the syringe with the injectable drug contained in the vitals and inserts the needle subcutaneously to self-inject.

JP 2004-555 A

When it comes to self-injection of insulin and other drugs by diabetic patients, for example, the Japan Diabetes Association, a public interest incorporated association, has drawn up guidelines on how to inject, and patients use a syringe they have purchased to refill with the injectable medication prescribed by their doctor each time they need an injection, and then self-inject based on these guidelines.

When patients self-inject insulin etc. in this way, they measure their own blood glucose levels at the required times and decide for themselves what time of day and how much of an injectable drug (insulin etc.) to inject. For example, a therapy has been adopted in which blood glucose levels are measured before and after meals, and the patient injects the required amount of injectable drug from a syringe loaded with a vital sign container (5ml, 10ml etc.) at the required time in several doses, thereby controlling blood glucose levels themselves. However, it is considered to be very troublesome for the patient to record the injection time and amount of injectable drug each time.

The present invention aims to provide a syringe that allows the amount of injection drug (medicinal liquid) to be measured with simple operations and that allows the amount and injection time of the injection drug to be injected by the syringe to be managed, and a management device for the injection drug injected by the syringe.

In order to solve the above problems, the syringe of the present invention comprises a substantially cylindrical main body having an internal space, a pressure cylinder arranged within the main body so that its central axis is aligned with the axis of the central axis of the main body, a syringe barrel provided at the axial tip of the main body and having a drug solution filling space, an elastic member provided within the main body and biasing the pressure cylinder toward the tip in the axial direction, a pressure cylinder fixing mechanism that releasably fixes the pressure cylinder at a predetermined position at the rear end of the main body in the axial direction, a release unit that releases the fixed state by the pressure cylinder fixing mechanism, a gear unit provided to be rotatable relative to the main body around the axis, a stopper provided within the main body and movable along the axis by rotation of the gear unit, and regulating the range of displacement of the pressure cylinder within the internal space, and a detection unit that detects rotation information including the rotation angle and rotation direction of the gear unit. and an injection cylinder, the tip end side of the injection cylinder in the axial direction being arranged in a liquid-tight state within the drug solution filling space of the syringe barrel, the rear end side being arranged in an airtight state within the internal space, and the rear end surface being arranged to abut against the tip surface of the pressure cylinder fixed at a predetermined position, and furthermore being movable along the axial direction, the stopper is positioned at a position corresponding to the amount of drug solution to be injected into the subject by rotating the gear part, and the detection part detects rotation information related to this rotation operation, and the fixed state of the pressure cylinder fixed at the predetermined position is released by operating the release part, and the pressure cylinder is displaced toward the tip end until it abuts against the stopper according to the elastic force of the elastic member, thereby displacing the injection cylinder toward the tip end of the syringe barrel, thereby injecting the drug solution filled in the syringe barrel into the subject.

In the syringe of the present invention, it is preferable that the gear portion has an annular magnetic portion that rotates around an axis as the gear portion rotates, and the detection portion detects rotation information of the gear portion based on changes in the magnetic field distribution caused by the rotation of the magnetic portion.

In the syringe of the present invention, it is preferable that the position of the stopper is set according to the amount of medicinal liquid to be injected into the subject.

The syringe of the present invention preferably includes a communication unit that enables transmission and reception of signals between the syringe and an external device, and the communication unit preferably transmits the rotation angle detected by the detection unit to the external device when the release unit is operated.

The management device of the present invention is characterized by comprising a communication unit that enables mutual communication with the above-mentioned syringes, a calculation unit that calculates the amount of medicinal liquid injected into the subject based on the rotation angle, a memory unit that stores injection information regarding the injection of medicinal liquid into the subject and stores the amount of medicinal liquid calculated by the calculation unit linked to time information, and a management unit that manages the time of the next injection and the amount of medicinal liquid at the time of this injection based on the injection information, the amount of medicinal liquid calculated by the calculation unit, and the time information linked thereto.

The management device of the present invention is preferably configured with a mobile information terminal having functions corresponding to the communication unit, the calculation unit, the memory unit, and the management unit.

It is preferable that the management device of the present invention is provided with a warning unit that notifies the user of the time of the next injection.

The present invention provides a syringe that allows the amount of medicinal liquid (injection drug) injected to be measured with simple operations, and a management device that allows the amount and time of the medicinal liquid injected into a subject by the injection to be managed.

FIG. 1 is a perspective view showing a configuration of a syringe according to an embodiment of the present invention. 2A, 2B, and 2C are cross-sectional views taken along the axial direction of the syringe of FIG. 1. 3A is an enlarged view of the rear end portion of FIG. 2C, and FIG. 3B is a cross-sectional view taken along line 3B-3B' in FIG. 2A and 2B are cross-sectional views taken along the axial direction of the syringe of FIG. 1. 1A is an oblique view showing the relationship between the injection cylinder, the syringe barrel, the adapter, and the liquid medicine container; FIG. 1B is a cross-sectional view showing the injection cylinder and the syringe barrel connected to the liquid medicine container via the adapter; and FIG. 1C is a cross-sectional view showing the state in which the injection cylinder 100 is moved from the state shown in FIG. 1B to fill the liquid medicine into the syringe barrel. 1A is a cross-sectional view showing the state before the injection cylinder and the syringe barrel are pushed into the main body of the syringe with the adapter connected to the tip, FIG. 1B is a cross-sectional view showing the state after the rear end side of the injection cylinder has been pushed into the internal space of the syringe from the state of FIG. 1A, and FIG. 1C is a cross-sectional view showing the state after the adapter has been removed from the state of FIG. 6A is a partially enlarged view of FIG. 6C, and FIG. 6B is a cross-sectional view showing a state in which the stopper has been pulled up toward the rear end side from the state shown in FIG. 6A. 7(a) is a partially enlarged perspective view of FIG. 7(b), and FIG. 7(b) is a perspective view showing the external configuration of the vicinity of the grip portion of the syringe. 2A is a perspective view showing the external configuration of the rear end portion of the syringe shown in FIG. 1, and FIG. 2B is a cross-sectional view taken along the axial direction of the rear end portion of FIG. 4 is a cross-sectional view showing a configuration inside an internal space near a gear portion. FIG. 6(a) is a cross-sectional view along the axial direction corresponding to the state of FIG. 6(c), and FIG. 6(b) is a cross-sectional view showing the state in which an injection has been performed by operating the release button (release portion) from the state of FIG. 6(a). 11(a), (b), (c) and (d) are axial cross-sectional views showing the next injection step after the injection shown in FIG. 11(b). FIG. 2 is a functional block diagram of a management device including a syringe. 10 is a flowchart showing the flow of an injection using a syringe and a management device. 15 is a flowchart showing the process continuing from FIG. 14 . 16 is a flowchart showing the process continuing from FIG. 15 .

Hereinafter, a syringe and a management device according to an embodiment of the present invention will be described in detail with reference to the drawings.
1 or 2(a), (b), and (c), the syringe 10 according to this embodiment includes a main body 20, a pressing cylinder 30, a grip portion 40, a coil spring 50 as an elastic member, a pressing cylinder fixing mechanism 60, a release button 70 as a release portion, a gear portion 80, a stopper 90, an injection cylinder 100, and a syringe barrel portion 110. As shown in FIG. 13, the syringe 10 further includes a detection portion 120 and a communication portion 130.

2(a), (b), (c) and 4(a) and (b) show the state before the injection cylinder 100 is pushed into the internal space 21. In FIG. 2, the grip portion 40 is rotated counterclockwise around the axis AX of the central shaft from the initial state of (a) to raise the pressing cylinder 30 to the rear end side (D2 side), and in (c), the cylinder stopper 32 at the rear end of the pressing cylinder 30 is fixed to a predetermined position P1 (see FIG. 3(a)) by the pressing cylinder fixing mechanism 60. In FIG. 4, the grip portion 40 is rotated clockwise around the axis AX of the central shaft from the state corresponding to FIG. 2(c) to lower the pressing cylinder 30 to the tip side (D1 side).

Figures 12(a), (b), (c), and (d) are cross-sectional views showing the next injection step after the injection shown in Figures 11(a) and (b), showing the step of injecting the liquid medicine remaining in the syringe barrel 110. In Figure 12(a), the pressing cylinder 30 is pulled up toward the rear end 12 (D2 side) from the state at the end of the previous injection (Figure 11(b)) and fixed to the pressing cylinder fixing mechanism 60. In Figures 12(b) and (c), the stopper 90 is lowered to a position corresponding to the amount of liquid medicine to be injected by the rotation of the gear part 80. And Figure 12(c) shows the state in which the release button 70 is operated to inject the liquid medicine into the target site T.

As shown in FIG. 13, the syringe 10 is configured to be able to communicate with an external device, a management device 140, and the management device 140 includes a communication unit 141, a management unit 142, a calculation unit 143, a memory unit 144, a display unit 145, an input unit 146, and a warning unit 147.

<Syringe 10>
The components constituting the syringe 10 are preferably made of materials that are easy to sterilize and have high antibacterial properties. The injection cylinder 100 and the syringe barrel 110 are preferably made of materials that are durable against the medicinal solution, and are preferably made of disposable materials from a hygienic standpoint. Furthermore, the syringe 10 as a whole is preferably made of lightweight materials that are portable.

As shown in Figure 2, the main body 20 has a generally cylindrical shape with an internal space 21 extending along the axis AX of its central axis. In the following description, the direction D1 along the axis AX shown in Figures 1 and 2 (downward in Figures 2(a), (b), and (c)) is referred to as the tip end 11 side, and the direction D2 (upward in Figures 2(a), (b), and (c)) is referred to as the rear end 12 side.

A cylindrical pressing cylinder 30 is disposed within the main body 20 so as to be movable along the axis AX. The pressing cylinder 30 is disposed so that its central axis is aligned with the axis AX of the main body 20. The tip 31 of the pressing cylinder 30 is disc-shaped and centered on the axis AX, and its tip surface 33 is exposed within the internal space 21.

A flange-shaped cylinder stopper 32 that extends radially from the axis AX is provided at a predetermined position on the rear end side of the pressure cylinder 30. As shown in FIG. 3(a), a protrusion 32a that protrudes radially outward is provided on the outer edge of the cylinder stopper 32.

As shown in Fig. 1 and Fig. 2(a), (b), and (c), a grip portion 40 is provided at the rear end (end on the D2 side) of the main body portion 20. The grip portion 40 is a hollow cylinder whose central axis extends along the axis line AX. As shown in Fig. 4(a) and (b), the grip portion 40 includes an outer tube portion 41 that is rotatable about the axis line AX, and an inner tube portion 42 that is disposed along the inner peripheral surface of the outer tube portion 41. A spiral groove portion (not shown) that meshes with a spiral groove portion (not shown) formed on the inner peripheral surface of the outer tube portion 41 is formed on the outer peripheral surface of the inner tube portion 42. Therefore, the inner tube portion 42 moves toward the outer tube portion D1) or toward the rear end side (D2 direction).

The inner peripheral surface of the inner cylinder portion 42 forms a storage space 43 that is connected to the internal space 21 of the main body portion 20, and the rear end side of the pressure cylinder 30 is stored in this storage space 43.

A coil spring 50 is accommodated in the accommodation space 43 as an elastic member. This coil spring 50 is wound around the outer circumferential surface of the pressure cylinder 30, with its leading end fixed to the leading end portion 31 of the pressure cylinder 30 and its rear end fixed to the inner surface of the rear end side of the inner tube portion 42.

The tip side of the pressing cylinder 30 extends from the inner tube portion 42, and the amount of extension changes depending on the expansion and contraction of the coil spring 50. On the other hand, the tip portion 31 of the pressing cylinder 30 has an outer diameter larger than the inner diameter of the storage space 43, so when the pressing cylinder 30 moves relatively toward the rear end portion 12 with respect to the inner tube portion 42, the tip portion 31 abuts against the inner tube portion 42, restricting the relative movement of the pressing cylinder 30. Therefore, the tip portion 31 is always located outside the inner tube portion 42 regardless of the expansion and contraction state of the coil spring 50. With this configuration, the coil spring 50 can urge the pressing cylinder 30 toward the tip portion 11 in the direction of the axis AX.

As shown in Fig. 1 and Fig. 2(a), (b), and (c), a pressure cylinder fixing mechanism 60 is provided at the rear end of the grip portion 40. As shown in Fig. 3(a) and (b), the pressure cylinder fixing mechanism 60 has a configuration in which four slide stoppers 62 are provided inside a hollow, approximately cylindrical tubular body 61. The four slide stoppers 62 are provided at equal angular intervals with respect to the axis AX on the inner circumferential surface of the tubular body 61. The four slide stoppers 62 are each positioned via four pressure springs 63 fixed to the inner circumferential surface of the tubular body 61, and are therefore each biased toward the inside of the tubular body 61, i.e., in a direction approaching the axis AX.

3B, in a plan view along the axis AX, the cylindrical body 61 has a substantially circular space 64 surrounded by four slide stoppers 62, and the tip 71 of the release button 70 as a release part is inserted into this space 64. The release button 70 has a tapered cylindrical tip 71 and is provided to the cylindrical body 61 via a support spring 72. Therefore, the operation surface 73, which is the rear end surface of the release button 70, extends from the rear end surface of the cylindrical body 61 due to the elastic force of the support spring 72 (see FIG. 9). In response to this, the release button 70 can be pushed down toward the inside of the cylindrical body 61 by pushing the operation surface 73 toward the tip side (D1 side) against the elastic force of the support spring 72. The tip 71 of the release button 70 has a shape in which the outer diameter increases as it approaches the operation surface 73. When the release button 70 is pressed down, the four slide stoppers 62 are pushed apart in the radial direction relative to the axis AX according to the inclined shape of the tip 71.

The four slide stoppers 62 are also pushed apart in the radial direction relative to the axis AX by raising the pressure cylinder 30 in the D2 direction. That is, when the pressure cylinder 30 is first raised, the protrusions 32a of the cylinder stoppers 32 come into contact with the four slide stoppers 62. When the pressure cylinder 30 is raised further from this point, the protrusions 32a have an inclined surface whose outer diameter becomes smaller as it approaches the release button 70 side (rear end portion 12 side, D2 direction), so that the slide stoppers 62 are pushed apart.

The inner circumferential surface of the slide stopper 62 is provided with a groove 62a formed to be recessed radially outward. As described above, when the pressing cylinder 30 is raised while pushing the slide stopper 62 apart and reaches the position of the groove 62a, the protrusion 32a of the cylinder stopper 32 fits into the groove 62a, and the pressing cylinder 30 is fixed at this position P1 (predetermined position, FIG. 3(a)). This fixed state is released when the user presses down on the release button 70 from the outside and applies a downward force (in the direction of D1) to the cylinder stopper 32 with the release button 70, thereby removing the protrusion 32a from the groove 62a.

As shown in Figures 2(a), (b), and (c), a gear unit 80 is provided on the tip side (D1 direction) of the main body unit 20. The gear unit 80 has a hollow cylindrical shape with a central axis extending along the axis line AX, and is rotatable relative to the main body unit 20 around the axis line AX.

A stopper 90 is disposed inside the gear portion 80. The stopper 90 is a hollow cylinder whose central axis extends along the axis line AX. This forms an internal space 81 inside the gear portion 80 and the stopper 90, the tip side of which is connected to the internal space 21 of the main body portion 20, and the rear end side of which is connected to the storage space 43 of the grip portion 40.

The outer peripheral surface of the stopper 90 is formed with a spiral groove portion (not shown) that meshes with a spiral groove portion (not shown) formed on the inner peripheral surface of the gear portion 80. Therefore, when the gear portion 80 is rotated, the stopper 90 moves toward the tip end (D1 direction) or the rear end (D2 direction) along the axis AX according to the direction of rotation (see Figures 7(a) and (b)). Since the diameter of the inner peripheral surface of the stopper 90 is set smaller than the outer diameter of the tip portion 31 of the pressing cylinder 30, when the pressing cylinder 30 is moved toward the tip end (D1 side), the position of the pressing cylinder 30 is restricted by abutting against the stopper 90.

The movement of the pressure cylinder 30 causes the injection cylinder 100 (described below) that is placed against the tip surface 33 of the pressure cylinder 30 to move. Therefore, by restricting the range of movement of the pressure cylinder 30 with the stopper 90, the range of movement of the injection cylinder 100 that moves while remaining in contact with the pressure cylinder 30 is also restricted, so that the amount of medicinal liquid injected by the movement of the injection cylinder 100 can be regulated. As shown in FIG. 8(b), a counter 22 is provided on the outer circumferential surface of the main body 20, and the displayed value changes according to the amount of rotation of the gear unit 80. This change in value allows the subject to recognize the planned amount of medicinal liquid to be injected.

As shown in FIG. 8(a), a magnetic part, a circular magnetic disk 82 centered on the axis AX, is fixed to the bottom surface of the tip side of the gear part 80. This magnetic disk 82 rotates around the axis AX together with the gear part 80. The magnetic properties of the magnetic disk 82 are distributed so that the distribution of the generated magnetic field changes with rotation. For example, it is configured so that the magnetic poles are different at equal angular intervals about the axis AX.

A detection unit 120 (encoder) capable of detecting changes in magnetism is provided on the D1 side (tip portion 11 side) of the magnetic disk 82. The detection unit 120 detects the magnetic field distribution (rotation information) that changes according to the rotation direction and rotation angle when the magnetic disk 82 rotates along with the rotation of the gear portion 80, and can use a Hall element or other magnetic sensor. The detection result is output to the control unit 121 (see FIG. 13).

As shown in FIG. 10, an annular substrate 23 is provided in the internal space 21 near the gear portion 80, and is arranged perpendicular to the axis AX. A light-emitting diode 122 (LED) and a phototransistor 123 are arranged on either side of the axis AX on this substrate 23. The light-emitting diode 122 emits inspection light toward the axis AX of the central axis in accordance with a control signal from the control unit 121, and the transmitted light that has passed through the injection cylinder 100 enters the phototransistor 123. The detection signal from 123 is input to the control unit 121, as shown in FIG. 13.

In the region where the light-emitting diode 122 and the phototransistor 123 face each other, the injection cylinder 100 is inserted along the axis AX of the central axis, as described below, and is movable along the axis AX of the central axis. In the injection cylinder 100, a groove 101a is provided on the outer circumferential surface of the approximately cylindrical main body 101, centered on the axis AX of the central axis. The groove 101a has convex and concave portions formed at regular intervals in the direction of the axis AX of the central axis. The inspection light emitted from the light-emitting diode 122 is detected by the phototransistor 123 in different results depending on the difference in the shapes of the convex and concave portions of the groove 101a. Furthermore, the control unit 121 can calculate the movement distance of the main body 101 of the injection cylinder 100 (the number of convex and concave portions of the groove 101a) based on the relationship between the convex and concave portions of the groove 101a and the change in the detection signal from the time change of the detection signal of the phototransistor 123 from the operation of the release button 70. This allows you to check whether a predetermined amount of liquid medicine has been injected based on the position of the stopper 90.

As shown in Fig. 5(b) and Figs. 6(a), (b), and (c), the injection cylinder 100 comprises a substantially cylindrical main body 101 and a cylindrical leading end 102 extending from the main body 101. The main body 101 and the leading end 102 extend about the same axis, the main body 101 has a groove 101a on its outer circumferential surface, and the leading end 102 has an outer diameter smaller than the recess of the groove 101a.

6(b) and (c), the injection cylinder 100 is disposed within the internal space 21 of the syringe 10. Within the internal space 21, the rear end surface 103 of the main body 101 is disposed so as to abut against the tip surface 33 of the pressing cylinder 30 within the internal space 21, and the leading end 102 extends outward from the tip 11 of the syringe 10. Since the injection cylinder 100 abuts against the pressing cylinder 30, when the pressing cylinder 30 is moved toward the tip 11 (D1 side), the injection cylinder 100 moves together with the pressing cylinder 30. At this time, the main body 101 moves along the axis AX of the central shaft while maintaining an airtight state against the inner peripheral surface of the internal space 21.

As shown in Figure 5 (b) and Figures 6 (a), (b), and (c), the leading end 102 of the injection cylinder 100 is disposed within the drug solution filling space 111 inside the cylindrical syringe barrel 110, and is movable along the central axis of the syringe barrel 110 in a liquid-tight state.

When filling the drug solution filling space 111 of the syringe barrel 110 with the drug solution, the syringe barrel 110 is connected to the drug solution container 210 via the adapter 200 as shown in FIG. 5(a). As shown in FIG. 5(b), a hollow needle portion 201 is provided in the adapter 200 to allow the drug solution to flow between the tip 104 of the leading end 102 of the injection cylinder 100 and the drug solution container 210. By screwing the syringe barrel 110 to the adapter 200, the internal spaces of the needle portion 201 and the tip portion 104 are airtightly connected to each other, and further, by screwing the adapter 200 to the drug solution container 210, the tip of the needle portion 201 reaches the drug solution filled in the drug solution container 210. As a result, the internal space of the tip portion 104 is connected to the inside of the drug solution container 210 via the needle portion 201.

As shown in FIG. 5(b), when the injection cylinder 100 is moved in a direction in which the tip 104 moves away from the adapter 200 as shown in FIG. 5(c) from a state in which the internal space of the tip 104 is in communication with the inside of the drug solution container 210, the drug solution filling space 111 of the syringe barrel 110 becomes negative pressure, so that the drug solution is sucked up from the drug solution container 210 into the drug solution filling space 111. By moving the tip 104 of the injection cylinder 100 to a predetermined position within the syringe barrel 110, a certain amount of drug solution is filled into the drug solution filling space 111 of the syringe barrel 110.

When a certain amount of the liquid medicine has been filled as described above, the liquid medicine container 210 is removed. Then, the injection cylinder 100 with the adapter 200 and the syringe barrel portion 110 connected is pushed into the internal space 21 of the syringe 10 from the rear end face 103 as shown in FIG. 6(a), and is positioned so that the rear end face 103 abuts against the tip face 33 of the pressing cylinder 30 as shown in FIG. 6(b). Furthermore, as shown in FIG. 6(c), the adapter 200 is removed, and after rotating the gear portion 80, a certain amount of the liquid medicine in the syringe barrel portion 110 is injected by operating the release button 70.

<Management Device 140>
Next, the management device 140 will be described with reference to Fig. 13. The management device 140 includes a communication unit 141 that enables mutual transmission and reception between the management device 140 and the communication unit 130 of the syringe 10. These communication units 130 and 141 can be wireless or wired and can use any appropriate communication standard, taking into account the expected communication distance, cost, etc. For example, when an individual has the syringe 10 and the management device 140, it is preferable to use Bluetooth (registered trademark) since they are used at a relatively short distance.

The management device 140 includes a management unit 142 and an input unit 146. The management unit 142 controls the communication unit 141, the calculation unit 143, and the memory unit 144, and also manages the time of the next injection and the amount of medicinal liquid for this injection based on the injection information, the amount of medicinal liquid calculated by the calculation unit, and the time information linked to this, and this information is stored in the memory unit 144.

The injection information is input by the subject operating the input unit 146 and is stored in the memory unit 144. The injection information includes, for example, the subject's age, sex, height, weight, type of medicinal liquid, planned daily dose of medicinal liquid, number of doses per day, planned dose per dose and corresponding change in the value on the counter 22, and planned time of administration.

The detection result by the detection unit 120 of the syringe 10 is transmitted from the communication unit 130 to the communication unit 141 of the management device 140 under the control of the control unit 121. The transmitted detection result is used by the calculation unit 143 to calculate the rotation direction and rotation angle of the gear unit 80 based on the change in magnetic field distribution as the detection result, and the amount of medicinal liquid ejected, i.e., the amount of medicinal liquid injected into the subject, is calculated from the rotation direction and rotation angle. This calculation result is stored in the memory unit 144 and is displayed on the display unit 145.

The warning unit 147 issues a warning after an injection, for example, to inform the user of the time of the next injection. In addition, the warning unit 147 compares the planned amount of medicinal liquid to be ejected, calculated from the rotation angle of the gear unit 80, with the injection information stored in the memory unit 144, and if a difference of a predetermined percentage, for example ±10%, is found with respect to the planned amount of injection planned in the injection information, the warning unit 145 displays a warning message to request the user to review the rotation settings of the gear unit 80. This makes it possible to prevent errors in the amount of medicinal liquid to be administered due to incorrect operation of the gear unit 80 in advance.

The warning unit 147 issues a warning, for example, by emitting an alarm sound. It can also output a warning signal to the management unit 142, and based on this, cause the display unit 145 to display an alarm.

The management device 140 can be configured by applying dedicated software (application, app) to a mobile information terminal or personal computer (PC) in addition to a dedicated device. A mobile information terminal, such as a smartphone, can have functions corresponding to the communication unit 141, management unit 142, calculation unit 143, memory unit 144, display unit 145, input unit 146, and warning unit 147.

Next, an example of a processing flow using the syringe 10 and the management device 140 will be described with reference to Figures 14 to 16. Steps S11 to S29 on the left side of Figures 14 to 16 show the processing in the syringe 10, and steps S41 to S53 on the right side show the processing in the management device 140 (smartphone, PC, etc.).

In the management device 140, the app (software) is started (step S41), and the required insulin injection amount and the required number of injections are set as injection information by operating the input unit 146 (step S42). In addition, the input unit 146 is operated to set an alarm notification for the injection time that matches the lifestyle of the user (subject) (step S43). An example of this setting is when a working subject sets the injection time to be during their break or a time before or after work.

On the other hand, the operation on the syringe 10 side involves rotating the grip portion 40 to pull up the pressing cylinder 30, and then fixing the pressing cylinder 30 with the pressing cylinder fixing mechanism 60 (step S11).

The entire amount of insulin as a medicinal liquid is aspirated from the medicinal liquid container 210 into the syringe barrel 110 that is not inserted into the main body 20 (step S12). This aspirating is performed by first screwing the syringe barrel 110 with the injection cylinder 100 inserted thereinto into the adapter 200 as shown in FIG. 5(a), and then screwing the medicinal liquid container 210 into the adapter 200. This allows the syringe barrel 110 to communicate with the medicinal liquid container 210 via the needle 201 (FIG. 5(b)). From this state, the injection cylinder 100 is pulled up in a direction away from the medicinal liquid container 210, whereby insulin is aspirated into the medicinal liquid filling space 111. When the aspirating is completed in this manner, the medicinal liquid container 210 is removed from the adapter 200.

After steps S11-12 and S41-43, the management device 140 goes into standby mode (step S44). After that, when the injection time set in step S43 arrives, an alarm is generated (step S45). In addition, the Bluetooth (registered trademark) of the communication unit 141 on the management device 140 side is set to the on state.

When the subject activates the syringe 10 in response to the notification in step S45 (step S13), the Bluetooth (registered trademark) of the communication unit 130 is turned on (step S14), and communication with the management device 140 via Bluetooth (registered trademark) is possible (steps S15, S46). As a result, the app in the management device 140 detects that the power of the syringe 10 has been turned on (step S47).

After starting the syringe 10 in step S13, the subject pushes the injection cylinder 100 into the internal space 21 of the main body 20 of the syringe 10 (FIG. 6(b)) with the syringe barrel 110 into which insulin was inhaled in step S12 and the injection cylinder 100 and adapter 200 connected to it still in a combined state (see FIG. 6(a)). Here, the pressing cylinder 30 is pulled down to the injection standby position by the rotation of the grip part 40 after the cylinder stopper 32 is fixed by the pressing cylinder fixing mechanism 60 (the same state as FIG. 4(b)), and the injection cylinder 100 is positioned so that its rear end surface 103 abuts against the tip surface 33 of the pressing cylinder 30 (FIG. 6(b)). After this, the adapter 200 is removed as shown in FIG. 6(c).

Here, the injection cylinder 100 may be inserted into the internal space 21 in the standby mode of step S44. Also, the injection cylinder 100 may be inserted into the internal space 21 after the gear portion 80 has rotated and before the release button 70 is operated.

Next, the subject rotates the gear unit 80 to set the amount of medicinal liquid to be injected. The amount of rotation of the gear unit 80 is set according to the amount of insulin to be injected at that time, and the amount of change in the number on the counter 22 corresponding to the amount of rotation is displayed on the display unit 145. The subject rotates the gear unit 80 so that the number displayed on the counter 22 changes by the number displayed on the display unit 145. The specific processing procedure at this time is as follows:

First, in step S12, the entire amount of insulin is drawn from the drug solution container 210 into the syringe barrel 110, and while maintaining this state, the injection cylinder 100 is pushed into the internal space 21 until it abuts against the pressing cylinder 30. If an injection is performed from this state without rotating the gear portion 80 (NO in step S16), 100% (initial value) of the insulin in the syringe barrel 110 is injected (step S48). In contrast, when the gear portion 80 is rotated, the amount of movement of the pressing cylinder 30 and the injection cylinder 100 is reduced by the amount of rotation, and therefore the amount of insulin injected is also reduced.

When the gear portion 80 rotates (YES in step S16), the magnetic disk 82 rotates together with the gear portion 80 (step S17), and the surrounding magnetic field distribution changes according to the rotation direction and rotation angle of the magnetic disk 82.

The change in the magnetic field distribution caused by the rotation of the magnetic disk 82 is detected by the magnetic sensor of the detection unit 120 (rotary encoder) (step S18) and transmitted to the management device 140.

The management device 140 counts the pulses in the pulse signal that indicates the change in the magnetic field distribution over time (step S19), and calculates the rotation direction and rotation angle of the gear unit 80 based on the count (step S20). The rotation direction and rotation angle calculated in this way (rotation angle position data) are transmitted to the management device 140 (steps S21, S49).

When the above steps are completed, the light-emitting diode 122 (LED) in the syringe 10 starts emitting light (step S22), and the search light from the light-emitting diode 122 is received by the phototransistor 123 (step S23).

The light-emitting diode 122 may be illuminated by operating the input unit 146 of the management device 140 immediately before operating the release button 70, to output a signal to the syringe 10 instructing the light-emitting diode 122 to emit light, and the light-emitting diode 122 may be illuminated in response to this.

Next, with the syringe barrel 110 of the syringe 10 placed against the injection site T (see FIG. 11(b)), the release button 70 is pressed (step S24). This releases the fixed state by the pressing cylinder fixing mechanism 60, and the pressing cylinder 30 moves toward the tip 104 (step S25). As the pressing cylinder 30 moves, the injection cylinder 100 that is in contact with it also moves (step S25), and the medicinal liquid in the syringe barrel 110 is ejected, performing the injection.

In step S25, the injection cylinder 100 is moved, and the inspection light from the light-emitting diode 122 passes through the injection cylinder 100, causing the transmitted light to enter the phototransistor 123. The amount of transmitted light changes according to the uneven shape of the groove portion 101a provided in the injection cylinder 100, and the phototransistor 123 detects the change in the amount of transmitted light (step S26).

The result of the change in the amount of transmitted light detected by the phototransistor 123 is sent to the management device 140 (steps S27 and S50). The calculation unit 143 of the management device 140 calculates the amount of injected medicinal liquid based on the detection result by the phototransistor 123 and the detection result by the detection unit 120, and stores this in the memory unit 144 together with the time of injection (step S51).

The amount of drug solution to be injected calculated in step S51 above is displayed on the display unit 145. The display unit 145 displays a message urging the user to turn off the power to the syringe 10 after checking the amount of drug solution to be injected. When the syringe 10 is turned off accordingly, the communication unit 130 (Bluetooth (registered trademark)) of the syringe 10 is also turned off (step S29), and communication with the management device 140 is cut off (step S52). The management device 140 then transitions to an app standby mode in which it waits until the next alarm time (step S53).

Modifications will be described below.
In the above embodiment, the magnetic disk 82 is provided in the gear portion 80 as the magnetic portion, but other configurations may be used as long as the magnetic field distribution changes with the rotation of the gear portion 80. For example, the gear portion 80 itself may be made of a magnetic material having different magnetic poles at equal angular intervals with respect to the axis line AX.

In the above embodiment, the distribution of the magnetic field caused by the rotation of the magnetic disk 82 was detected by the detection unit 120, but instead of this, it may be detected by optical means. For example, instead of the magnetic disk 82, optical disks with different optical properties, such as reflectance, transmittance, and color, may be used at equal angular intervals about the axis AX, and changes in optical properties caused by the inspection light from the light-emitting unit reaching the optical disk may be detected. This makes it possible to use it even in cases where a device that generates a magnetic field cannot be used.

In the above embodiment, the syringe 10 and the management device 140 were capable of transmitting and receiving data via Bluetooth (registered trademark) (registered trademark), but if they are capable of communicating using a peer-to-peer method and the detection data on the syringe 10 is transmitted and received as a code signal, the communication capacity can be kept small, making it possible to make the communication unit 130 on the syringe 10 small and low-cost.
Although the present invention has been described with reference to the above-mentioned embodiment, the present invention is not limited to the above-mentioned embodiment, and improvements or modifications can be made within the scope of the present invention or the purpose of the improvements.

LIST OF SYNTHESIS 10 Syringe 11 Tip of syringe 12 Rear end of syringe 20 Main body 21 Internal space 22 Counter 23 Base plate 30 Pressing cylinder 31 Tip of pressing cylinder 32 Cylinder stopper 32a Projection 33 Tip surface of pressing cylinder 40 Grip 41 Outer cylinder 42 Inner cylinder 43 Storage space 50 Coil spring 60 Pressing cylinder fixing mechanism 61 Cylindrical body 62 Slide stopper 62a Groove 63 Pressing spring 64 Space 70 Release button 71 Tip of release button 72 Support spring 73 Operation surface 80 Gear 81 Internal space 82 Magnetic disk 90 Stopper 100 Injection cylinder 101 Main body 101a Groove 102 Leading end 103 Rear end surface 104 Tip portion 110 Syringe barrel portion 111 Drug solution filling space 120 Detection portion 121 Control portion 122 Light emitting diode (LED)
123 Phototransistor 130 Communication unit 140 Management device 141 Communication unit 142 Management unit 143 Calculation unit 144 Memory unit 145 Display unit 146 Input unit 147 Warning unit 200 Adapter 201 Needle unit 210 Drug solution container AX Axis line of central axis

Claims (3)

A management device for managing an injection drug to be injected by a syringe,
The syringe comprises:
A substantially cylindrical main body having an internal space;
A pressing cylinder disposed within the main body such that a central axis of the pressing cylinder is aligned with the axis of the central axis of the main body;
a syringe barrel portion provided at a tip end of the main body portion in the axial direction and having a drug solution filling space;
an elastic member provided in the main body portion and biasing the pressing cylinder toward the tip portion in the axial direction;
a pressing cylinder fixing mechanism that releasably fixes the pressing cylinder at a predetermined position of a rear end portion of the main body in the axial direction;
A release unit that releases the fixed state by the pressing cylinder fixing mechanism;
a gear portion provided to be capable of rotating relatively to the main body portion about the axis;
a stopper provided in the main body portion, movable along the axis by rotation of the gear portion, and regulating a range of displacement of the pressing cylinder within the internal space;
A detection unit that detects rotation information including a rotation angle and a rotation direction of the gear unit;
An injection cylinder;
Equipped with
the injection cylinder has a front end side in the axial direction disposed liquid-tight within the drug solution filling space of the syringe barrel, and a rear end side disposed airtight within the internal space, the rear end surface being disposed so as to abut against a front end surface of the pressing cylinder fixed at the predetermined position, and is movable along the axial direction;
By rotating the gear portion, the stopper is disposed at a position corresponding to the injection amount of the medicinal liquid to be injected into the subject, and the detection unit detects the rotation information related to this rotation operation.
By operating the release unit, the fixed state of the pressing cylinder that was fixed at the predetermined position is released, and the pressing cylinder is displaced toward the tip end of the syringe until it abuts against the stopper in accordance with the elastic force of the elastic member, thereby displacing the injection cylinder toward the tip end of the syringe barrel, thereby injecting the medicinal solution filled in the syringe barrel into the subject;
The syringe includes a communication unit capable of transmitting and receiving signals between an external device,
The communication unit transmits the rotation angle detected by the detection unit to the external device when the release unit is operated,
The management device includes:
A communication unit that enables communication with the syringe;
A calculation unit that calculates an amount of the medicinal solution injected into the subject based on the rotation angle;
A storage unit that stores injection information regarding the injection of the medicinal liquid to the subject and stores the amount of the medicinal liquid calculated by the calculation unit in association with time information;
A management unit that manages the next injection time and the amount of the medicinal liquid at the time of this injection based on the injection information, the amount of the medicinal liquid calculated by the calculation unit, and the time information associated therewith;
An input unit for inputting the injection information;
Equipped with
An alarm notification setting for the next injection time is performed according to the subject's lifestyle by operating the input unit,
A management device characterized by having a standby mode in which, after the alarm notification is set, the management device waits until the time for the next injection arrives. The management device according to claim 1 , wherein the management device is configured by a portable information terminal having functions corresponding to the communication unit, the calculation unit, the storage unit, and the management unit, respectively. The management device according to claim 1 or 2, further comprising an alarm unit that notifies the user of the time of the next injection.

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