Drug solution administration device, control method for same, and program

Abstract

A drug solution administration device according to the present invention comprises a pump body and is for administration of a drug solution that has been filled into a reservoir. The pump body comprises a pump that delivers the drug solution that has been filled into the reservoir and a control unit. During delivery of the drug solution, the control unit repeats a first operation and a second operation in response to the pressure of the drug solution in a passage that leads the drug solution to the outside of the reservoir having reached a predetermined reference pressure value until a prescribed amount of the drug solution is delivered. The first operation suspends delivery of the drug solution by the pump, and the second operation restarts delivery of the drug solution after a predetermined fixed amount of time has passed from suspension of the delivery of the drug solution.

Description

Drug solution administration device, control method thereof, and program

[0001] The present disclosure relates to a drug solution administration device, a control method thereof, and a program.

[0002] A drug solution administration device that administers a drug solution such as insulin into a patient's body is known. Patent Document 1 describes a technique related to controlling the reverse rotation speed of a drive unit when it is detected that an obstruction has occurred in a flow path of a drug solution.

[0003] Japanese Patent No. 7105791

[0004] However, the conventional configuration had room for improvement in that there was a case where an obstruction was erroneously detected even though there was actually no obstruction.

[0005] An object of the present disclosure is to reduce false detection of obstructions in a drug solution administration device.

[0006] According to the present disclosure, a drug solution administration device 1 is a drug solution administration device including a pump body that administers a drug solution filled in a reservoir, the pump body including a pump that transfers the drug solution filled in the reservoir and a control unit, the control unit performing a first operation of stopping the transfer of the drug solution by the pump in response to the pressure of the drug solution in a flow path that leads the drug solution outside the reservoir reaching a predetermined reference pressure value during the transfer of the drug solution by the pump, and a second operation of restarting the transfer of the drug solution after a predetermined fixed time has elapsed since the transfer of the drug solution was stopped, and repeating the operations until a predetermined amount of the drug solution is transferred.

[0007] (2) In the drug solution dispensing device of (1), the pump body comprises: a plunger provided in the reservoir and movable in the longitudinal direction of the reservoir; a movable part that moves within a movable region to engage with the plunger and press the plunger toward the tip of the reservoir; and a drive unit that moves the movable part within the movable region. The drive unit comprises: a motor that rotates; a power transmission mechanism that transmits the rotational driving force of the motor as a driving force for moving the movable part within the movable region; and a rotation detection unit that detects a rotation sensor value relating to the rotational speed of a rotating body connected to the motor when a drive signal for one rotation is output to the motor. The control unit may acquire the rotation sensor value detected by the rotation detection unit as a value relating to the pressure of the drug solution in the flow path.

[0008] (3) In the drug dispensing device of (2), the control unit may detect an obstruction in the flow path when the number of times the rotation sensor value reaches a predetermined reference value becomes equal to or greater than a predetermined reference number.

[0009] (4) In the drug solution dispensing device of (3), the control unit may detect blockage in the flow path when the number of rotation sensor values ​​that have reached the reference value among the most recently acquired predetermined number of rotation sensor values ​​reaches the reference value or equals the reference number of times.

[0010] (5) In any of the drug administration devices described in (1) to (4), the control unit may output an alarm to the output unit in response to detecting an obstruction in the flow path.

[0011] According to this disclosure, a method for controlling a drug solution dispensing device is (6) a method for controlling a drug solution dispensing device comprising a pump body for dispensing a drug solution filled in a reservoir, wherein the pump body comprises a pump for transferring the drug solution filled in the reservoir, and a control unit, and the control unit includes, while the pump is transferring the drug solution, a first operation in which the pump stops transferring the drug solution in a flow path leading the drug solution out of the reservoir when the pressure of the drug solution in that flow path reaches a predetermined reference pressure value, and a second operation in which the pump resumes transferring the drug solution after a predetermined period of time has elapsed since the transfer of the drug solution was stopped, and repeats these until a predetermined amount of the drug solution has been transferred.

[0012] According to this disclosure, the program is a program for controlling a drug dispensing device comprising a pump body for dispensing a drug solution filled in a reservoir, wherein the pump body comprises a pump for transferring the drug solution filled in the reservoir, a detection unit for detecting the pressure of the drug solution in a channel leading the drug solution out of the reservoir, and a control unit, and the control unit is instructed to execute a procedure which is repeated until a predetermined amount of the drug solution is transferred, in which a first operation is performed to stop the transfer of the drug solution by the pump when the pressure of the drug solution in the channel leading the drug solution out of the reservoir reaches a predetermined reference pressure value, and a second operation is performed to resume the transfer of the drug solution after a predetermined period of time has elapsed since the transfer of the drug solution was stopped.

[0013] According to one embodiment of the present disclosure, it is possible to reduce false detection of blockage in a drug administration device.

[0014] This figure shows an example of a drug solution administration system according to one embodiment. This is a perspective view showing an example of the drug solution administration device of Figure 1. This is a perspective view showing an example of the drug solution administration device in a separated state. This is a perspective view showing an example of the pump body of Figure 3. This is a perspective view showing an example of the pump body in a disassembled state. This figure shows an example of a cartridge with the nut in a non-contact position. This figure shows an example of a cartridge with the nut in a predetermined position. This figure shows an example of the configuration near the drive unit of the drug solution administration device. This is a perspective view showing an example of the rotating body of Figure 8. This figure illustrates the acquisition of rotation sensor values ​​by a rotation sensor. This is a block diagram showing an example of the configuration related to the control of the drug solution administration device of Figure 1. This is a block diagram showing an example of the hardware configuration of the controller of Figure 1. This figure shows an example of the control of the drive unit in response to a change in injection pressure. This figure shows an example of the control of the drive unit in response to a change in injection pressure. This is a flowchart showing an example of the operation of the drug solution administration device of Figure 1

[0015] Hereinafter, an embodiment of the present disclosure will be described with reference to the drawings. In each drawing, parts having the same configuration or function are denoted by the same reference numerals. In the description of this embodiment, redundant descriptions of the same parts may be omitted or simplified as appropriate.

[0016] (Example of configuration of drug administration system 100) Figure 1 is a diagram showing an example of a drug administration system 100 according to one embodiment. The drug administration system 100 administers a drug solution such as insulin into the patient's body. The drug administration system 100 comprises a drug administration device 1 and a controller 90.

[0017] The drug administration device 1, as described later with reference to Figure 5, is a device that continuously or intermittently administers a drug solution filled in a reservoir (syringe) 18 into the body by the pressing action of a plunger 20. The drug administration device 1 may be a portable device that can be attached to the patient's abdomen, etc. (patch type). However, the drug administration device 1 is not limited to a patch type and may be a tube type, etc.

[0018] The controller 90, as an information processing device in this embodiment, is a device for a user, such as a patient, to operate the drug administration device 1. The controller 90 notifies the user of information received from the drug administration device 1 and accepts user operations on the drug administration device 1. In this embodiment, the controller 90 is implemented by a dedicated device corresponding to the drug administration device 1, but it may also be implemented by a general-purpose computer such as a smartphone or tablet. Furthermore, in this embodiment, an example is described in which the controller 90 is responsible for the user interface, such as notifying the user of information and accepting information input from the user, but instead, the drug administration device 1 may be provided with all or part of the functions of the user interface. In this embodiment, the user who uses the drug administration system 100 is the patient themselves, but the user may also be a person other than the patient, including the patient's family, and medical professionals such as doctors and nurses.

[0019] The drug dispensing device 1 and the controller 90 are connected to each other via a wireless communication line, a wired communication line, or a combination thereof. An example of how the drug dispensing device 1 and the controller 90 are connected via Bluetooth® will be described below.

[0020] (Example of configuration of drug administration device 1) Figure 2 is an example of a perspective view of the drug administration device 1 of Figure 1. Figure 3 is an example of a perspective view of the drug administration device 1 of Figure 1 when it is separated. The drug administration device 1 includes a pump body 10, a cradle device 11 to which the pump body 10 is detachably mounted, and a cannula report 106 mounted on the cradle device 11. The pump body 10 and the cradle device 11 have a structure that allows them to engage with each other and be repeatedly attached and detached. Figure 4 is a perspective view showing an example of the pump body 10 of Figure 3.

[0021] The pump body 10 includes a housing 111 that accommodates the various components of the drug delivery device 1, such as the reservoir 18 and the plunger 20. As illustrated in Figures 2 and 3, the housing 111 may be formed in a flattened, substantially rectangular parallelepiped shape with curved corners. The upper surface 121 of the housing 111 is one side of the pump body 10 that is opposite to the side that is mounted on the cradle device 11. The upper surface 121 may be formed in a substantially rectangular shape with curved corners when viewed from above. At the first end of the upper surface 121, a front surface 123 and a rear surface 124 are continuously connected substantially vertically to each other. At the second end of the upper surface 121, a first side surface 125 and a second side surface 126 are continuously connected substantially vertically to each other.

[0022] As shown in Figures 2 and 3, when the power source for the drug administration device 1 is a rechargeable battery 42 (see Figure 6), the pump body 10 is provided with a connector section 75 and an alert section 77 on its upper surface 121. The connector section 75 is a connector to which a power supply can be connected. The power supply is any device for charging the rechargeable battery 42. The power supply is, for example, a charging cable connected to an external power source, but it may also be any connection terminal provided on the external power source. The following explanation will focus on an example in which a charging cable connected to an external power source is used as the power supply.

[0023] When a charging cable is connected to the connector 75, the pump body 10 receives power from the power source via the charging cable and charges the rechargeable battery 42 (see Figure 6) provided in the device body 14. The connector 75 is, for example, a connector conforming to a general-purpose standard such as USB (Universal Serial Bus), but it may be implemented by other methods that can receive power. In Figures 2 and 3, the connector 75 is provided on the top surface 121, but it may be provided at any position on the pump body 10 (for example, on the side of the pump body 10). The connector 75 may be equipped with a cap to prevent dust and other debris from entering when the charging cable is not connected. In this embodiment, the connector 75 can be connected to a wired charging cable, but the drug dispensing device 1 may have a configuration for receiving power by a wireless power supply method.

[0024] The notification unit 77 notifies the user of information. In this embodiment, the notification unit 77 is, for example, an LED (Light Emitting Diode) lamp, but it may also be a speaker that outputs sound, a display that outputs images (for example, a liquid crystal display), a vibrator, or a combination thereof. When a charging cable is connected to the connector unit 75, the notification unit 77 may inform the user of the charging status, etc., by the color and state of the LED lamp (for example, lit, blinking, etc.). The notification unit 77 may also include an LED lamp that displays a pattern indicating an action to be encouraged or prohibited by the user. In Figures 2 and 3, the notification unit 77 is provided on the top surface 121, but it may also be provided at any position on the pump body 10 (for example, on the side of the pump body 10, etc.).

[0025] As shown in Figures 3 and 4, the pump body 10 may have a reusable engagement structure at the first side portion 125 and the second side portion 126 that allows the pump body 10 and the cradle device 11 to be repeatedly attached and detached. The engagement structure may include, for example, a hook mechanism. Specifically, the first side portion 125 may have a first guide groove portion 135 and a first engagement hook portion 136. The second side portion 126 may have a second guide groove portion 137 and a second engagement hook portion 138. The first engagement hook portion 136 may be formed closer to the rear portion 124 than the first guide groove portion 135. The second engagement hook portion 138 may be formed closer to the rear portion 124 than the second guide groove portion 137. The first engagement hook portion 136 and the second engagement hook portion 138 may be reusably engaged with a pair of engagement receiving portions 162 of the cradle device 11, which will be described later.

[0026] The cradle device 11 is configured to support the pump body 10. As shown in Figures 2 and 3, the cradle device 11 has a substantially flat mounting surface portion 141 and side wall portions 143 and 144. The mounting surface portion 141 is formed in a substantially rectangular shape with curved corners when viewed from above. When the pump body 10 is mounted on the cradle device 11, the bottom surface portion 122 (see Figure 4) of the housing 111 of the pump body 10 is placed on the mounting surface portion 141.

[0027] A detection rail 152, a sliding rail 153, and a mounting portion 155 may be provided on one side of the mounting surface 141. A cannula report 106 may be mounted on the mounting portion 155. The mounting portion 155 may be provided with an insertion hole through which the cannula of the cannula report 106 is inserted.

[0028] The detection rail 152 is a protruding portion that extends from one surface of the mounting surface 141. The detection rail 152 is used to detect when the pump body 10 is mounted on the cradle device 11. The thickness of the detection rail 152 gradually increases from the mounting surface 141 towards the side wall 144. The detection rail 152 extends parallel to the side wall 143 for a predetermined length. When the pump body 10 is mounted on the cradle device 11, the detection rail 152 enters into a detection groove 134 provided on the pump body 10 and presses the mounting detection switch 133. The pump body 10 detects that the cradle device 11 is mounted based on the pressing of the mounting detection switch 133. In other words, the mounting detection switch 133 functions as a determination unit that determines whether or not the pump body 10 is mounted on the cradle device 11.

[0029] The sliding rail 153 extends parallel to the side wall 143 on one surface of the mounting surface 141. When the pump body 10 is mounted on the cradle device 11, the sliding groove 132 provided on the bottom surface 122 of the pump body 10 slides into the sliding rail 153.

[0030] A side wall portion 144 is continuously attached to the end of the mounting surface portion 141 in a first direction, extending substantially perpendicularly. Two opposing side wall portions 143 are continuously attached to the end of the mounting surface portion 141 in a second direction, extending substantially perpendicularly. When the pump body 10 is mounted on the cradle device 11, the side wall portion 143 faces the first side portion 125 and the second side portion 126 of the housing 111 of the pump body 10. The side wall portion 144 faces the front portion 123 of the housing 111.

[0031] As shown in Figure 3, the cradle device 11 may have a fitting hole 154, which is an opening, in the side wall portion 144. When the pump body 10 is mounted on the cradle device 11, a fitting projection 131 (see Figure 4) provided on the front portion 123 of the pump body 10 may fit into the fitting hole 154.

[0032] Guide rails 151, posture correction parts 156, and engagement receiving parts 162 may be formed on the side wall portion 143. The engagement receiving parts 162 may be an opening cut out in a substantially rectangular shape from the side wall portion 143. The engagement receiving parts 162 may be provided on the side wall portion 143 facing each other, depending on the arrangement of the first engagement hook portion 136 and the second engagement hook portion 138. When the pump body 10 is mounted on the cradle device 11, the first engagement hook portion 136 and the second engagement hook portion 138 may be detachably engaged with the engagement receiving parts 162.

[0033] As shown in Figure 3, the guide rail 151 is a protruding portion formed on the side wall portion 143. The guide rail 151 does not necessarily have to be a continuous protruding portion. For example, as shown in Figure 3, a notch 158 may be appropriately provided in the middle of the guide rail 151. The guide rail 151 may be provided for each of the opposing side wall portions 143. When the pump body 10 is mounted on the cradle device 11, the guide rail 151 engages with the first guide groove portion 135 provided on the first side portion 125 and the second guide groove portion 137 provided on the second side portion 126 of the pump body 10. This guides the mounting direction of the pump body 10.

[0034] As shown in Figures 2 and 3, the posture correction portion 156 is a plate-shaped projection extending upward from the side wall portion 143. The posture correction portion 156 may have a curved shape corresponding to the shape of the connection portion (corner) between the upper surface portion 121 of the housing 111 of the pump body 10 and the first side portion 125 and the second side portion 126.

[0035] The cradle device 11 may be provided with an adhesive sheet that can be attached to the patient's skin. The adhesive sheet may be attached to the other side of the mounting surface 141 of the cradle device 11, opposite to one side. The adhesive sheet may have an opening through which the cannula of the cannula report 106, described later, can pass. The adhesive sheet may be made of a flexible material. The adhesive sheet may form an adhesive layer on the side opposite to the mounting surface 141 that can be attached to the patient's skin. Before being attached to the patient's skin, the adhesive layer of the adhesive sheet may be covered with release paper.

[0036] The cannula report 106 may have a port body 181 capable of holding a cannula inside. The port body 181 may have a cylindrical connector. When a cannula is connected, the inside of the connector (cylindrical opening), the port body 181, and the cannula are in communication. A cap 182 is attached to the tip of the connector, and the other end of the connector is connected to the port body 181. The cap 182 seals the tip opening of the connector. As a result, the inside of the cannula report 106 is isolated from the external environment.

[0037] When the cannula report 106 is attached to the mounting section 155 of the cradle device 11 using a puncture mechanism (not shown), the cannula, together with the puncture needle, penetrates the mounting surface 141 and protrudes to the other side of the mounting surface 141 (the side that is attached to the skin). The cannula, together with the puncture needle, is then punctured into the body. After that, the cannula is left in the body by removing the puncture needle.

[0038] The connection portion of the port body 181 may face the upstream side in the mounting direction. The connecting needle tube 112 (see Figure 4), which is exposed to the outside of the pump body 10, is fluidly connected to the outlet tube 29. The connecting needle tube 112 enters the cylindrical hole by puncturing the septum surface of the cap 182. This connects the port body 181 to the outlet tube 29 (see Figure 6, etc.) of the pump body 10, and the outlet tube 29 and the cannula are fluidly connected. The drug solution stored in the reservoir 18 of the pump body 10 is then sent to the cannula report 106 via the outlet tube 29 and administered to the patient through the cannula when the drive unit 40 (see Figure 6, etc.) is driven. In other words, the outlet tube 29 is connected to the reservoir 18 and also acts as a flow path for guiding the drug solution out of the reservoir 18. When the connecting needle tube 112 is connected to the outlet tube 29, the flow path of the drug administration device 1 may include the outlet tube 29 and the connecting needle tube 112.

[0039] Figure 4 shows a perspective view of an example of the pump body 10, viewed from a direction that shows the bottom surface 122, the front surface 123, and the first side surface 125. The bottom storage section 127 is formed at the corners of the bottom surface 122, the first side surface 125, and the front surface 123 of the housing 111. The bottom storage section 127 is a recessed space of a predetermined length (thickness) and a predetermined area (width) extending from the bottom surface 122 to the top surface 121.

[0040] A cylindrical connection port 128 is formed in the wall surface 127a on the rear side 124 in the first direction of the bottom storage section 127. The connection port 128 has a cylindrical hole 128a that protrudes from the wall surface 127a toward the front side 123 in the first direction (i.e., toward the mounting direction). A connecting needle tube 112 is placed in the cylindrical hole 128a of the connection port 128. The cylindrical hole 128a protrudes from the wall surface 127a so as to surround the connecting needle tube 112, thereby protecting the connecting needle tube 112. In addition, the connecting needle tube 112 protrudes from the wall surface 127a toward the front side 123 in the first direction ( toward the mounting direction) within the cylindrical hole 128a. That is, the direction in which the connection port 128 protrudes from the wall surface 127a is parallel to the first direction.

[0041] When the pump body 10 is mounted on the cradle device 11, the cannula report 106 attached to the cradle device 11 is accommodated in the bottom surface storage portion 127. Further, the port body 181 and the cap 182 of the cannula report 106 are inserted into the cylindrical hole 128a of the connection port 128. Also, the connection syringe 112 protrudes from the wall surface 127a toward the front portion 123 side in the first direction (i.e., in the mounting direction) within the cylindrical hole 128a. That is, the direction in which the connection syringe 112 protrudes from the wall surface 127a is parallel to the first direction.

[0042] (Configuration example of the pump body 10) FIG. 5 is an example of an exploded perspective view of the pump body 10 in FIG. 3. FIG. 6 is a view showing an example of the cartridge 12 in a state where the nut portion 24 is in a non-contact position. FIG. 7 is a view showing an example of the cartridge 12 in a state where the nut portion 24 is in a predetermined position.

[0043] As shown in FIG. 5, the pump body 10 includes a disposable cartridge 12 and a reusable device body 14. The cartridge 12 includes a base portion 16 having a flat box shape with one side open. The base portion 16 has a substantially rectangular shape in plan view. The base portion 16 may be detachably provided with respect to the cradle device 11 that can be attached to the patient's skin.

[0044] As shown in FIG. 5, the base portion 16 is provided with a reservoir 18 filled with a chemical solution, a plunger 20 provided in the reservoir 18, a feed screw shaft 22 disposed coaxially with the plunger 20, and a nut portion (movable portion) 24 screwed to the feed screw shaft 22. The base portion 16 is configured as a disposable member.

[0045] The reservoir 18 extends in a cylindrical shape in the longitudinal direction of the base portion 16. The distal end portion of the reservoir 18 has a reduced outer diameter and inner diameter toward the distal end. An introduction port 26 for introducing the chemical solution into the reservoir 18 and a discharge port 28 (see FIG. 6) for discharging the chemical solution in the reservoir 18 are formed at the distal end portion of the reservoir 18 having such a shape. A discharge pipe 29 for guiding the chemical solution in the reservoir 18 to the cannula communicates with the discharge port 28.

[0046] As shown in Figure 6, the plunger 20 is integrally molded from a resin material or the like and is installed inside the reservoir 18 so as to be liquid-tight and slidable along the axial direction of the reservoir 18. The plunger 20 has a plunger body 30 that constitutes the front end and a pusher 32 that is provided on the plunger body 30 and constitutes the rear end. A sealing member (sealing member) 34 is attached to the cylindrical rear end of the plunger body 30. The sealing member 34 is attached to the outer surface of the plunger body 30. The sealing member 34 presses against the inner wall surface of the reservoir 18 to prevent leakage of the chemical solution filled in the reservoir 18. The sealing member 34 moves back and forth in the left-right direction on the inner wall surface of the reservoir 18 while fitting with the cylindrical inner wall surface, so as not to leak the chemical solution from the boundary between the plunger body 30 and the inner wall surface of the reservoir 18. The size of the internal space of the reservoir 18 containing the liquid chemical changes depending on the position of the plunger body 30 in the reservoir 18. In this embodiment, the sealing member 34 is made of an O-ring, but it is not limited to this as long as it can prevent the liquid chemical in the reservoir 18 from leaking out between the plunger body 30 and the inner surface of the reservoir 18. The sealing member 34 may be made of an elastic material, for example, silicone rubber.

[0047] The plunger 32 comprises a pair of extensions 36 extending rearward from the plunger body 30 to the outside of the reservoir 18, and a pair of claws 38 provided at the rear ends of the extensions 36. The lead screw shaft 22 is supported at one end by a bearing 39 and constitutes a drive unit 40 that moves the nut portion 24 within its movable range.

[0048] The drive unit 40 further includes a rechargeable battery 42 as a power source, a motor 44 driven by the rechargeable battery 42, a gearbox (power transmission mechanism) 46 that reduces and transmits the rotational driving force of the motor 44, and a transmission shaft 52 to which a spur gear 50 that meshes with the output gear 48 of the gearbox 46 is fixed and integrally rotatable with the lead screw shaft 22.

[0049] In this embodiment, the transmission shaft 52 is provided on the cartridge 12, and the rechargeable battery 42, motor 44, and gearbox 46 are provided on the main body 14 of the device. By providing the rechargeable battery 42, motor 44, and gearbox 46 on the main body 14 in this way, the cost of the cartridge 12 can be reduced.

[0050] The rechargeable battery 42 is a secondary battery that can be repeatedly charged and discharged. The rechargeable battery 42 is, for example, a lithium-ion battery, but may also be other types of secondary batteries such as lithium-ion solid-state batteries, high-energy-density batteries, organic cathode secondary batteries, sodium-ion batteries, or potassium-ion batteries. The rechargeable battery 42 is provided with terminals 54 that electrically connect to the motor 44 of the device body 14 when the device body 14 is connected to the cartridge 12. The transmission shaft 52 is supported by a pair of bearings 56 provided on the base portion 16, and is arranged coaxially with the lead screw shaft 22.

[0051] Instead of the rechargeable battery 42, a primary battery can be installed in the cartridge 12 as a power source. In this case, once the cartridge 12 and the main unit 14 are connected, power is supplied to the main unit 14.

[0052] When the motor 44 rotates, its rotational force is transmitted to the lead screw shaft 22, and the rotational action of the lead screw shaft 22 causes the nut portion 24 to move either toward the reservoir 18 or toward the reservoir 18. Hereinafter, the rotation of the motor 44 that causes the nut portion 24 to move toward the reservoir 18 will be called forward rotation (forward rotation). Rotation in the opposite direction to the forward direction will be called reverse rotation (reverse rotation). The motor 44 is configured to be able to rotate in both the forward and reverse directions. The motor 44 is configured such that if a force exceeding a certain level is applied to the forward or reverse rotation, the rotational driving force is not transmitted to the gearbox 46 and the components below. For example, a stepping motor may be used as the motor 44. If a stepping motor is used, when a force exceeding a certain level is applied to the forward or reverse rotation, the motor 44 will no longer synchronize with the input pulse and will not transmit the rotational driving force (loosening of steps). Even if the motor 44 rotates in the reverse direction while the nut portion 24 is in contact with the bearing 56 due to step loss, excessive force can be applied to the motor 44, gearbox 46, transmission shaft 52, and other mechanisms, preventing damage. A rotary encoder (not shown) is provided on the output shaft of the motor 44, and it is possible to determine when the motor 44 has lost synchronization with the input pulse (step loss) by detecting the rotation of the motor 44 using the rotary encoder. The operating state of the motor 44 is transmitted to the control unit 71 as the output of the rotary encoder.

[0053] The nut portion 24 is integrally molded from a resin material and has a nut portion body 58 formed in a substantially rectangular parallelepiped shape, and a slide portion 60 provided on the nut portion body 58. The nut portion body 58 has a screw hole 62 into which the feed screw shaft 22 is screwed, and a pair of through holes 64 formed on both sides of the screw hole 62 through which the claw portion 38 is inserted. A reinforcing cover 66 made of, for example, a metal material is attached to the outer surface of the nut portion body 58.

[0054] The sliding portion 60 slides against a guide wall 68 provided on the base portion 16 and extending along the axial direction of the plunger 20. That is, the nut portion 24 is in a non-contact position before use, not in contact with the plunger 20 (see Figure 6), and moves from the non-contact position to a contact position where the nut portion 24 and the plunger 20 are locked together by the rotational action of the lead screw shaft 22. After contacting the plunger 20, the nut portion 24 presses the plunger 20 toward the tip as the lead screw shaft 22 rotates further (see Figure 7). A regulating portion may be provided on the guide wall 68 to act as a stopper to prevent the sliding portion 60 from retracting any further.

[0055] As shown in Figures 5 to 7, the main body of the device 14 includes a lid that is detachably attached to the base portion 16 so as to close the opening of the base portion 16, as well as a control unit 71, a storage unit 72, and a communication unit 73. The lid may be provided on the upper surface 121 of the housing 111. The control unit 71 is electrically connected to a rechargeable battery 42, a motor 44, a storage unit 72, a communication unit 73, a charging circuit unit 74, a connector unit 75, a rotation sensor 76, and a notification unit 77 via a bus 79 (see Figure 11). The control unit 71 controls each part of the drug dispensing device 1 and executes processes related to the operation of the drug dispensing device 1. For example, the control unit 71 drives the motor 44 based on drug dispensing information transmitted from the controller 90.

[0056] Figure 8 shows an example of the configuration near the drive unit 40 of the drug administration device 1. As shown in Figure 8, the gearbox 46 has a mechanism that combines multiple gears. The gearbox 46 transmits the rotational force of the motor 44 to the lead screw shaft 22 via the spur gear 50. When the lead screw shaft 22 rotates in the forward direction, the nut portion 24 moves toward the reservoir 18. As a result, the nut portion 24 presses the plunger 20 toward the tip. Due to the pressure of the plunger 20, the drug solution stored in the reservoir 18 is sent toward the patient via the outlet tube 29.

[0057] As shown in Figure 8, the drive shaft of the motor 44 is equipped with a rotating body 78 and a rotation sensor 76, which acts as a rotation detection unit for detecting the rotation of the rotating body 78. In the example in Figure 8, the rotation sensor 76 is a rotary encoder that detects the rotation of the rotating body 78.

[0058] Figure 9 is a perspective view showing an example of the rotating body 78 of Figure 8. The rotating body 78 has a rotating body main body portion 781 fixed to the drive shaft of the motor 44, three shielding plates 782 provided on the rotating body main body portion 781, and a shaft portion 783 provided on the rotating body main body portion 781.

[0059] The rotating body portion 781 is formed in a substantially cylindrical shape. The rotating body portion 781 rotates in synchronization with the rotation of the drive shaft of the motor 44. A shaft portion 783 protrudes from the side of the rotating body portion 781 opposite the motor 44 in the axial direction. A gear (not shown) is provided on the shaft portion 783 and meshes with the gears of the gearbox 46.

[0060] Three shielding plates 782 are provided on the outer circumferential surface of the rotating body portion 781 at equal angular intervals. Between adjacent shielding plates 782, three slits 784 are formed at equal angular intervals, creating spaces where no shielding plate 782 exists.

[0061] The rotation sensor 76 (rotary encoder) may be placed in the housing of the gearbox 46. The rotation sensor 76 is an optical encoder. The rotation sensor 76 has a light-emitting part that emits light and a light-receiving part that receives the light emitted from the light-emitting part. Depending on the amount of rotation of the rotating body 78, the light emitted from the light-emitting part is either blocked by the shielding plate 782 or passes through the slit 784 and reaches the light-receiving part.

[0062] As described above, the rotating body 78 has three shielding plates 782 and three slits 784 formed alternately and at equal angles from the central axis of the rotating body 78 toward the outer circumference. Therefore, when the drive shaft of the motor 44 rotates once, i.e., when the rotating body 78 rotates once, the state of the light-receiving part of the rotation sensor 76 changes six times between an "off" state where light is blocked by the shielding plates 782 and an "on" state where light passing through the slits 784 is detected. The rotation sensor 76 emits pulsed light at least 18 sampling intervals while the rotating body 78 rotates once in a normal operating state, and is configured to detect the switch from "on" to "off".

[0063] The number of shielding plates 782 and slits 784 is not limited to three each, but can be any number. The pulse signal generated when the rotating body 78 completes one rotation changes appropriately according to the number of shielding plates 782 and slits 784.

[0064] The rotation sensor 76 inputs rotation information (hereinafter referred to as "rotation sensor value") regarding the rotation state of the rotating body 78 when a drive signal for one rotation is output to the motor 44 from the control unit 71 (see Figure 10), which will be described later, to the control unit 71. The input rotation sensor value is reset each time the motor 44 completes one rotation.

[0065] Figure 10 illustrates the acquisition of rotation sensor values ​​by the rotation sensor 76. Figure 10 shows the input signal to the rotation sensor 76 and the rotation sensor value based on the input signal during the time (predetermined time) it takes for the motor 44 to complete one normal rotation. In Figure 10, the horizontal axis represents time.

[0066] Graph 251 shows the changes in the "on" and "off" signals detected by the light-receiving part of the rotation sensor 76. In Figure 10, High in Graph 251 indicates "on," and Low indicates "off."

[0067] The rotation sensor 76 detects light at the light-receiving unit at a predetermined sampling period. Symbol 252 indicates the timing of light detection at the light-receiving unit. For example, in Figure 10, "off" (Low) is detected between sampling timings 1 to 4. "On" (High) is detected between sampling timings 5 ​​to 7.

[0068] In this embodiment, the control unit 71 (see Figure 10), described later, filters the sampled data related to the rotation of the rotating body 78 detected by the rotation sensor 76 using a software filter. Specifically, the control unit 71 defines the signal level when two signals of the same level (High or Low) are detected consecutively. For example, in Figure 10, the light input to the rotation sensor 76 is "off" at sampling timing 4 and "on" at sampling timing 5 (Graph 251), but the filtered signal switches from "off" to "on" at sampling timing 6 (Graph 253). Through this process, the drug dispensing device 1 can stably detect the rotation of the rotating body 78 even if the rotation sensor 76 incorrectly detects "on" or "off" for some reason. The filtering of sampled data is not limited to defining the signal level when two signals of the same level (High or Low) are detected consecutively. For example, the drug dispensing device 1 may define the signal level when three or more signals of the same level are detected consecutively. Alternatively, the drug dispensing device 1 may choose not to perform such filtering.

[0069] The drug dispensing device 1 increments the rotation sensor value by 1 in accordance with the switching between "on" and "off" in the filtered signal. In this way, when the rotating body 78 has three shielding plates 782 and three slits 784, the rotation sensor value is counted by 6 while the motor 44 rotates normally once.

[0070] If the pressure in the flow path is high, the back pressure of the chemical solution makes it difficult for the plunger 20 to move forward, which makes it difficult for the gears in the gearbox 46 to rotate. As a result, even if a drive signal is output to the motor 44 to rotate once, the rotating body 78 may not complete a full rotation. In such cases, when a drive signal is output to the motor 44 to rotate once, the rotation sensor value may only count values ​​of the first value (e.g., 4) or less during the predetermined time required for the motor 44 to complete one rotation normally. This indicates that the rotational speed of the rotating body 78 is lower than normal. This is because the period of being in the "on" or "off" state is extended compared to the normal operating state. Also, if the force that causes the rotating body 78 to rotate in response to the drive signal is in equilibrium with the back pressure, the rotating body 78 may repeatedly stop at a certain position or move slightly. In such cases, when a drive signal is output to the motor 44 to rotate once, the "on" or "off" state is repeated more frequently than in the normal operating state, so the rotation sensor value may only count values ​​of the second value (e.g., 8) or more. Therefore, when a drive signal is output to the motor 44 to rotate it once, the drug dispensing device 1 can detect an increase in pressure in the flow path based on the rotation sensor value observed within a predetermined time (for example, 0.05 to 0.2 seconds).

[0071] Figure 11 is a block diagram showing an example of the configuration related to the control of the drug administration device 1 in Figure 1. As described above, the control unit 71 is electrically connected to the rechargeable battery 42, motor 44, memory unit 72, communication unit 73, charging circuit unit 74, connector unit 75, rotation sensor 76, and notification unit 77 via the bus 79.

[0072] The control unit 71 is one or more processors. The control unit 71 is communicatively connected to each component constituting the drug solution dispensing device 1 and controls the operation of the entire drug solution dispensing device 1. The processor is a general-purpose processor such as a CPU (Central Processing Unit), or a dedicated processor specialized for a specific process. The control unit 71 may include one or more dedicated circuits, or one or more processors in the control unit 71 may be replaced with one or more dedicated circuits. A dedicated circuit is, for example, an FPGA (Field Programmable Gate Array).

[0073] The storage unit 72 is one or more semiconductor memories, one or more magnetic memories, one or more optical memories, or a combination of at least two of these. The semiconductor memory is, for example, RAM (Random Access Memory) or ROM (Read Only Memory). The storage unit 72 functions, for example, as a main memory, auxiliary memory, or cache memory. For example, the storage unit 72 may store information from the control unit 71. The information stored in the storage unit 72 may also be transmitted to the controller 90 via the communication unit 73 under the control of the control unit 71.

[0074] The communication unit 73 is a communication interface for communicating with the controller 90. In this embodiment, the communication unit 73 communicates with the controller 90 via Bluetooth®, but is not limited to this, and may communicate via other wireless communication paths such as a wireless LAN (Local Area Network) or a wired cable.

[0075] The charging circuit section 74 is an electrical circuit for transferring power supplied from the power source connected to the connector section 75 to the rechargeable battery 42. The charging circuit section 74 includes a switch that can switch between electrical connection and disconnection between the connector section 75 and the rechargeable battery 42.

[0076] The configuration of the rechargeable battery 42, motor 44, connector section 75, rotation sensor 76, and notification section 77 is as described above.

[0077] The drug dispensing device 1 may be controlled by executing a program on a processor included in the control unit 71. In other words, the control of the drug dispensing device 1 may be implemented by software. In this case, the program causes the computer to execute the processing of steps included in the operation of the drug dispensing device 1, thereby enabling the computer to implement the functions corresponding to the processing of those steps. Alternatively, some or all of the functions of the drug dispensing device 1 may be implemented by a dedicated circuit included in the control unit 71. In other words, some or all of the functions of the drug dispensing device 1 may be implemented by hardware.

[0078] (Example of Controller 90 Configuration) Figure 12 is a block diagram showing an example of the hardware configuration of the controller 90 shown in Figure 1. The controller 90 comprises a control unit 91, a storage unit 92, a communication unit 93, an input unit 94, an output unit 95, and a bus 99.

[0079] The control unit 91 is one or more processors. The control unit 91 is communicated with each component constituting the controller 90 via the bus 99 and controls the operation of the entire controller 90. The processor is a general-purpose processor such as a CPU or GPU (Graphics Processing Unit), or a dedicated processor specialized for a specific process. The control unit 91 may include one or more dedicated circuits, or one or more processors in the control unit 91 may be replaced with one or more dedicated circuits. A dedicated circuit is, for example, an FPGA.

[0080] The memory unit 92 is one or more semiconductor memories, one or more magnetic memories, one or more optical memories, or a combination of at least two of these. The semiconductor memory is, for example, RAM or ROM. The RAM is, for example, SRAM (Static RAM) or DRAM (Dynamic RAM). The ROM is, for example, EEPROM (Electrically Erasable Programmable ROM). The memory unit 92 functions, for example, as a main memory, an auxiliary memory, or a cache memory.

[0081] The communication unit 93 is a communication interface for communicating with the drug dispensing device 1. The communication unit 93 communicates with the drug dispensing device 1 to transmit information entered by the user to the drug dispensing device 1 and to receive information from the drug dispensing device 1. The communication unit 93 communicates with the drug dispensing device 1 by, for example, Bluetooth®, but is not limited to this, and may communicate by other wireless communication paths such as wireless LAN or wired cables.

[0082] The input unit 94 includes one or more input interfaces that receive user input operations and acquire input information based on the user operations. The input unit 94 is, for example, a touchscreen integrated with the display (display device) of the output unit 95, but is not limited to this, and may also be a physical key (e.g., an external numeric keypad), a capacitive key, a pointing device, or a microphone that accepts voice input.

[0083] The output unit 95 includes one or more output interfaces that output information to the user and notify the user. For example, the output unit 95 is a display, LED, speaker, or vibrator that outputs information by displaying an image, but is not limited to these. The input unit 94 and the output unit 95 act as an input / output unit, which is an interface between the user and the drug administration device 1. In this embodiment, an example is described in which such an input / output unit is provided in the controller 90, but it may also be provided in the drug administration device 1 or other devices.

[0084] The functions of the controller 90 may be realized by executing the program according to this embodiment on a processor included in the control unit 91. In other words, the functions of the controller 90 may be realized by software. In this case, the program causes the computer to execute the processing of steps included in the operation of the controller 90, thereby realizing the functions corresponding to the processing of those steps on the computer. Alternatively, some or all of the functions of the controller 90 may be realized by a dedicated circuit included in the control unit 91. In other words, some or all of the functions of the controller 90 may be realized by hardware.

[0085] (Example of operation of drug administration system 100) When operating the drug administration system 100 according to this embodiment, first the user removes the cartridge 12 from the packaging container. In this state, the reservoir 18 of the cartridge 12 is not filled with drug solution, and the nut portion 24 is in a non-contact position that does not come into contact with the plunger 20 (see Figure 6).

[0086] Next, the user adjusts the position of the plunger 20 relative to the reservoir 18 and fills the reservoir 18 with a desired amount of drug solution from a drug solution container such as a vial in which the drug solution is sealed, through the introduction port 26. After that, the user connects the main unit 14 of the device to the cartridge 12. As a result, power from the rechargeable battery 42 of the cartridge 12 is supplied to the components of the main unit 14, and the output gear 48 of the gearbox 46 of the main unit 14 meshes with the spur gear 50 of the cartridge 12. The control unit 71, memory unit 72, etc. are started up by receiving power from this rechargeable battery 42.

[0087] Next, the user fills the cartridge 12, which has been removed from the packaging container, with the drug solution, connects the cartridge 12 to the main body of the device 14, and then performs priming of the drug solution dispensing device 1. Priming refers to the operation of locking the nut portion 24 of the drug solution dispensing device 1 onto the plunger 20 and filling the flow path of the drug solution dispensing device 1, including the outlet tube 29, with the drug solution. Specifically, the user operates the controller 90 to rotate the motor 44 in the forward direction. As a result, the rotational driving force of the motor 44 is transmitted to the lead screw shaft 22 via the gearbox 46, spur gear 50, and transmission shaft 52, causing the lead screw shaft 22 to rotate and the nut portion 24 to slide along the guide wall 68 and advance toward the plunger 20.

[0088] As the nut portion 24 advances toward the tip of the reservoir 18, the pair of claw portions 38 strike the wall surface forming the through hole 64 of the nut portion 24, causing the pair of extension portions 36 to bend so that they are close to each other. Then, when the claw portions 38 pass through the through hole 64, the extension portions 36 return to their original state from the bent state, and the nut portion 24 is locked against the rear end of the plunger 20. As a result, the nut portion 24 can press the plunger 20 toward the tip. Subsequently, by advancing the nut portion 24 further, the drug solution in the reservoir 18 is pressed against the plunger 20, filling the inner hole of the discharge tube 29 with the drug solution and completing the priming. This priming is completed when the user visually confirms that the drug solution has been discharged from the connecting needle tube 112, which is fluidically connected to the discharge tube 29 and exposed to the outside of the drug solution administration device 1. When the user visually confirms that the drug solution has been discharged from the connecting needle tube 112, they instruct the drug administration device 1 to stop priming. For example, the controller 90 may display an image of the priming stop button on the display of the output unit 95, and in response to the user selecting the priming stop button, notify the drug administration device 1 to stop the motor 44.

[0089] Next, the user attaches the cradle device 11 to a predetermined location on the skin (for example, the patient's abdomen), uses the puncture mechanism to implant the cannula of the cannula report 106 into the body, and locks the cannula report 106 to the cradle device 11. Then, the user attaches the pump body 10, to which the cartridge 12 and the device body 14 are connected, to the cradle device 11, thereby connecting the outlet tube 29 and the cannula. In this state, the control unit 71 controls the rotation of the motor 44, so that the drug solution in the reservoir 18 is continuously or intermittently administered into the body. The control unit 71 controls the rotation of the motor 44 according to the drug solution administration schedule instructed by the controller 90, and administers the drug solution at various rates such as the basal rate or bolus, according to the patient's condition. The basal rate is the amount of drug solution per unit time corresponding to the basal secretion of insulin. The bolus is the amount of drug solution corresponding to the additional secretion of insulin in response to a meal or an increase in blood glucose levels.

[0090] The reservoir 18 of the cartridge 12 is filled with the amount of drug solution to be administered in a fixed administration cycle. After the drug solution filled in the reservoir 18 is administered into the body over, for example, 3 days to a week, the cartridge 12 is replaced and discarded. The cartridge 12 is replaced with a new cartridge after each administration cycle. Each time the cartridge 12 is replaced, the drug solution is filled into the reservoir 18 of the cartridge 12, the cartridge 12 is connected to the device body 14, and a priming operation is performed. Through these operations, while the drug solution is being administered, the drug solution administration device 1 can estimate the amount of drug solution administered, for example, based on the rotation speed of the motor 44 performed during priming and fluid delivery. Since the drug solution administration device 1 according to this embodiment is equipped with a disposable cartridge 12 and a reusable device body 14, running costs can be reduced.

[0091] The amount of medication filled into the reservoir 18 of cartridge 12 varies depending on the patient's age and condition, even if the length of the administration cycle is the same. For example, if the reservoir 18 is filled with medication equivalent to three days' worth, adults will be filled with more medication than children.

[0092] When the drug administration device 1 detects an increase in pressure in the drug flow path, it determines that an obstruction has occurred in the flow path and issues an alarm. Since the rate at which blood glucose levels rise differs depending on the meal content, it is desirable for the drug administration device 1 to optimize the bolus injection rate according to the meal content. However, if a fast injection rate bolus is selected, the injection pressure (back pressure) of the drug solution tends to remain high due to differences and changes in the subcutaneous location and condition of insulin injection, as well as differences in body position. This sustained high injection pressure may be mistakenly detected as an obstruction in the flow path. Such misdetection of obstruction will be explained with reference to Figure 13A.

[0093] Figure 13A shows an example of control of the drive unit 40 in response to changes in injection pressure. In Figure 13A, the horizontal axis represents administration time. The vertical axis represents the injection pressure in the drug solution flow path. The reference pressure value A is the pressure value used as the reference for blockage detection. Graph 201 shows the change in injection pressure over time when the drug solution is administered at the baseline rate. Graph 202 shows the change in injection pressure over time when the drug solution is administered as a bolus. In the example in Figure 13A, when the drug solution is administered at the baseline rate, the injection pressure is at time t 12 The peak value is shown at time t. When the drug solution is administered as a bolus, the infusion pressure is at time t. 11 It shows the peak value.

[0094] When administering a drug solution into the body, it may take time for the drug solution to diffuse subcutaneously in the patient. Therefore, when administering a bolus volume in a single shot, the injection pressure may be higher than normal immediately after injection, even if there is no actual blockage in the flow path. In the example in Figure 13A, Graph 203 shows the change in injection pressure over time when the drug solution is administered as a bolus, even though no blockage has occurred. In the example in Graph 203, the injection pressure is at time t 11 The pressure has reached the reference pressure value A. However, if the system simply detects and notifies the user of a blockage immediately when the injection pressure in the flow path reaches the reference value, there is a possibility that a blockage may be mistakenly detected and reported when no blockage actually exists.

[0095] Therefore, when the drug administration device 1 according to this embodiment detects that the injection pressure (back pressure) has reached a reference pressure value, it temporarily stops the injection operation and resumes the injection operation after a certain period of time has elapsed. The drug administration device 1 repeats this operation multiple times until the instructed dosage has been administered. This operation will be explained with reference to Figure 13B.

[0096] Figure 13B shows an example of control of the drive unit 40 in response to changes in injection pressure. Similar to Figure 13A, in Figure 13B, the horizontal axis represents administration time. The vertical axis represents the injection pressure in the drug solution flow path. The reference pressure value A is the pressure value used as the reference for blockage detection. Graph 211 shows the change in injection pressure over time when the drug solution administration device 1 according to this embodiment administers a bolus of drug solution.

[0097] In the example shown in Figure 13B, the injection pressure is at time t. 21 The standard pressure value A is reached. In this case, the drug delivery device 1 temporarily stops the delivery of the drug. Due to the cessation of delivery, the drug diffuses under the patient's skin, and the injection pressure drops below the standard pressure value A. Therefore, the drug delivery device 1, at time t 22 The drug delivery device 1 restarts the delivery. In this way, when the drug delivery device 1 starts the delivery and detects that the injection pressure has reached the reference pressure value A, it temporarily stops the injection operation, and after a certain period of time has elapsed (for example, after 5 to 30 seconds), it restarts the injection operation. This operation is repeated multiple times (three times in the example of Figure 13B) until a predetermined dose is administered. Therefore, with the drug delivery device 1, even if the injection pressure temporarily reaches the reference pressure value A, it is possible to prevent false detection of blockage and the notification of an incorrect alarm. Furthermore, if the drug delivery device 1 stops the injection operation in response to the injection pressure reaching the reference pressure value A, but the pressure does not drop sufficiently after a certain period of time, it can detect a blockage and notify the user if an actual blockage has occurred. Even if the temporary stopping and restarting of the injection operation is within a predetermined number of times, if more than 5 minutes have elapsed since the blockage was detected, it may be determined that a blockage has occurred.

[0098] As described above, the drug dispensing device 1 may monitor the injection pressure and determine whether the operation of the drive unit 40 is normal or not based on the rotation sensor value detected by the rotation sensor 76 when a drive signal is output to rotate the motor 44 once. For example, the drug dispensing device 1 may determine that the drive unit 40 is operating "normally" if the rotation sensor value when a drive signal is output to rotate the motor 44 once is between 5 and 7 (a range obtained by adding or subtracting 1 from the ideal value of 6, which corresponds to an allowable error). The drug dispensing device 1 may determine that the operation of the drive unit 40 is in a "boundary state" between normal operation and a deviation state if the rotation sensor value detected when a drive signal is output to rotate the motor 44 once is between 3 and 4, or 8. The drug dispensing device 1 may determine that the operation of the drive unit 40 is in a "deviant state" that deviates from normal operation if the rotation sensor value detected when a drive signal is output to rotate the motor 44 once is between 0 and 2, or 9 or more. In this way, the drug dispensing device 1 can classify the rotation sensor value when a drive signal is output to rotate the motor 44 once into one of three operating categories: "normal," "boundary state," or "deviation state."

[0099] Here, if the drug administration device 1 experiences a "deviation state" M times (for example, 3 times) consecutively, it may stop the fluid delivery for a certain period of time (for example, 10 seconds) and then resume administration. If the drug administration device 1 experiences a total of L times (for example, 60 times) or more of "boundary states" or "deviation states" in the most recent K times (for example, 500 times) of operation, it may detect the occurrence of an obstruction, stop the fluid delivery, and notify an alarm. When the operation to rotate the motor 44 once is performed a certain number of times, the detection of a "boundary state" or "deviation state" more than a predetermined number of times corresponds to the case where the injection operation was stopped in response to the injection pressure reaching the reference pressure value A, but the pressure did not drop sufficiently after a certain period of time. An example of such operation will be explained with reference to Figures 14A and 14B.

[0100] Figures 14A and 14B are flowcharts illustrating examples of the operation of the drug dispensing device 1 shown in Figure 1. The operation of the drug dispensing system 100, described with reference to Figures 14A and 14B, may correspond to one of the control methods for the drug dispensing device 1. The operation of each step in Figures 14A and 14B may be performed based on control by the control unit 71 of the drug dispensing device 1. The drug dispensing device 1 performs the following processing while driving the motor 44 to deliver the liquid.

[0101] In step S1 of Figure 14A, the control unit 71 acquires the rotation sensor value when a drive signal is output to rotate the motor 44 once.

[0102] In step S2, the control unit 71 determines the operation classification based on the rotation sensor value acquired in step S1. As described above, for example, if the rotation sensor value is 5 to 7, the control unit 71 may determine it as "normal". If the rotation sensor value is 3 to 4 or 8, the control unit 71 may determine it as "boundary state". If the rotation sensor value is 0 to 2 or 9 or more, the control unit 71 may determine it as "deviation state".

[0103] In step S3, the control unit 71 stores the operation classification determined in step S2 in the storage unit 72.

[0104] In step S4, the control unit 71 determines whether the total number of "boundary states" or "deviation states" in the most recent K (e.g., 500) operation classifications is L (e.g., 60) or more. If the total number of "boundary states" or "deviation states" is L or more (YES in step S4), the control unit 71 proceeds to step S5; otherwise (NO in step S4), it proceeds to step S11 in Figure 14B. The time elapsed from the start of bolus administration may be defined, for example, in the range of 1 to 17 minutes.

[0105] In step S5, the control unit 71 stops the motor 44 and stops the fluid supply.

[0106] In step S6, the control unit 71 notifies the alarm. Specifically, the control unit 71 may make the notification unit 77 blink. Alternatively, the control unit 71 may send a signal to the controller 90 via the communication unit 73, and the controller 90 may notify the alarm via the display, LED, speaker, or vibrator of the output unit 95. After completing the process in step S6, the control unit 71 terminates the process of the flowchart.

[0107] In step S11 of Figure 14B, the control unit 71 determines whether all of the most recent M operation classifications (for example, 3 times) are "deviation states". If the control unit 71 determines that the operation is "deviation state" (YES in step S11), it proceeds to step S12; otherwise, it proceeds to step S1 of Figure 14A.

[0108] In step S12, the control unit 71 stops the motor 44 and stops the fluid supply.

[0109] In step S13, the control unit 71 determines whether a certain amount of time (for example, 10 seconds) has elapsed since the liquid supply was stopped in step S12. If the control unit 71 determines that the certain amount of time has elapsed (YES in step S13), it proceeds to step S14; otherwise (NO in step S13), it waits in step S13 until the certain amount of time has elapsed.

[0110] In step S14, the control unit 71 drives the motor 44 to resume fluid supply. After completing the process in step S14, the control unit 71 proceeds to step S1 in Figure 14A.

[0111] The control unit 71 stops the fluid delivery when the transfer of a predetermined amount of drug solution to be administered to the patient is completed during the operation of the flowcharts in Figures 14A and 14B. The amount of drug solution to be transferred to the patient is calculated based on the rotation speed of the motor 44. However, the operation of the motor 44 that falls under the "deviation state" category is not used as the basis for calculating the amount of drug solution to be transferred to the patient.

[0112] Thus, the drug dispensing device 1 detects an obstruction and issues an alarm if the total number of "boundary state" or "deviation state" classifications in the most recent K operation classifications is L or more. Therefore, the drug dispensing device 1 can notify the user if an obstruction in the drug flow path is suspected. Furthermore, if the drug dispensing device 1 experiences M consecutive "deviation state" operation classifications, it repeats a first operation to stop the drug transfer, and a second operation to resume the drug transfer after a predetermined period of time has elapsed since stopping the drug transfer, until a predetermined amount of drug transfer has been transferred. Therefore, the drug dispensing device 1 can accurately detect an obstruction when it is truly present, without falsely detecting an obstruction due to slow subcutaneous diffusion of the drug.

[0113] Figures 14A and 14B show an example of operation in which blockage is detected when the total number of "boundary state" or "deviation state" classifications in the most recent K operation classifications is L or more. However, the conditions under which the drug delivery device 1 detects blockage are not limited to these. For example, the drug delivery device 1 may detect blockage when the number of times the fluid delivery has been stopped exceeds a certain number. Such an example of operation will be explained with reference to Figures 15A and 15B.

[0114] Figures 15A and 15B are flowcharts illustrating examples of the operation of the drug administration device 1 shown in Figure 1. The operation of the drug administration system 100, described with reference to Figures 15A and 15B, may correspond to one of the control methods for the drug administration device 1. The operation of each step in Figures 15A and 15B may be performed based on control by the control unit 71 of the drug administration device 1.

[0115] In step S21 of Figure 15A, the control unit 71 acquires the rotation sensor value when a drive signal is output to rotate the motor 44 once.

[0116] In step S22, the control unit 71 determines the operation classification based on the rotation sensor value acquired in step S21. As described above, for example, if the rotation sensor value is 5 to 7, the control unit 71 may determine it as "normal". If the rotation sensor value is 3 to 4 or 8, the control unit 71 may determine it as "boundary state". If the rotation sensor value is 0 to 2 or 9 or more, the control unit 71 may determine it as "deviation state".

[0117] In step S23, the control unit 71 stores the operation classification determined in step S22 in the storage unit 72.

[0118] In step S24, the control unit 71 determines whether or not N (for example, 5) or more instances of fluid delivery cessation have occurred. Here, the control unit 71 may count the number of fluid delivery cessations as the number of cessations that occurred in a single administration command (for example, administration of 25U by bolus), or as the total number of fluid delivery cessations since the drug administration device 1 was started. The number of fluid delivery cessations is stored in the storage unit 72. If there are N or more instances of fluid delivery cessation (YES in step S24), the control unit 71 proceeds to step S25; otherwise (NO in step S24), it proceeds to step S31 in Figure 15B.

[0119] In step S25, the control unit 71 stops the motor 44 and stops the fluid supply.

[0120] In step S26, the control unit 71 notifies the alarm. Specifically, the control unit 71 may make the notification unit 77 blink. Alternatively, the control unit 71 may send a signal to the controller 90 via the communication unit 73, and the controller 90 may notify the alarm via the display, LED, speaker, or vibrator of the output unit 95. After completing the process in step S26, the control unit 71 terminates the process of the flowchart.

[0121] In step S31 of Figure 15B, the control unit 71 determines whether all of the most recent M operation classifications (for example, 3 times) are "deviation states". If the control unit 71 determines that the operation is "deviation state" (YES in step S31), it proceeds to step S32; otherwise, it proceeds to step S21 of Figure 15A.

[0122] In step S32, the control unit 71 stops the motor 44 and stops the fluid supply.

[0123] In step S33, the control unit 71 counts the number of times the fluid supply has been stopped. That is, the control unit 71 increments the number of times the fluid supply has been stopped, which is stored in the memory unit 72, by 1.

[0124] In step S34, the control unit 71 determines whether a certain amount of time (for example, 10 seconds) has elapsed since the liquid supply was stopped in step S32. If the control unit 71 determines that the certain amount of time has elapsed (YES in step S34), it proceeds to step S35; otherwise, it waits in step S34 until the certain amount of time has elapsed.

[0125] In step S35, the control unit 71 drives the motor 44 to resume fluid supply. After completing the process in step S35, the control unit 71 proceeds to step S21 in Figure 15A.

[0126] The control unit 71 stops the fluid delivery when the transfer of a predetermined amount of drug solution to be administered to the patient is completed during the operation of the flowcharts shown in Figures 15A and 15B. The amount of drug solution to be transferred to the patient is calculated based on the rotation speed of the motor 44. However, the operation of the motor 44 that falls under the "deviation state" category is not used as the basis for calculating the amount of drug solution to be transferred to the patient.

[0127] In this manner, the drug delivery device 1 detects an obstruction and issues an alarm if the drug delivery is stopped a certain number of times. Therefore, the drug delivery device 1 can notify the user if an obstruction in the drug delivery path is suspected. Furthermore, if the drug delivery device 1 experiences M consecutive "deviation" operation classifications, it repeats a first operation to stop the drug delivery, and a second operation to resume the drug delivery after a predetermined period of time has elapsed since the drug delivery was stopped, until a predetermined amount of drug delivery has been delivered. Therefore, the drug delivery device 1 can accurately detect an obstruction when it takes time for the drug delivery to diffuse subcutaneously, etc., and can accurately detect a true obstruction when one occurs.

[0128] As described above, the drug administration device 1 includes a pump body 10 that administers the drug solution filled in the reservoir 18. The pump body 10 includes a pump that transfers the drug solution filled in the reservoir 18 and a control unit 71. The drug administration device 1 administers the drug solution by repeating a first operation, in which the transfer of the drug solution is stopped when the pressure of the drug solution in the flow path reaches a reference pressure value, and a second operation, in which the transfer of the drug solution is resumed after a certain period of time has elapsed since the transfer of the drug solution was stopped, until a predetermined amount of drug solution has been transferred.

[0129] Thus, the drug administration device 1 does not immediately detect an obstruction when the pressure of the drug solution in the flow path reaches a reference pressure value. Therefore, the drug administration device 1 can prevent false detection of an obstruction in cases such as when it takes time for the drug solution to diffuse under the patient's skin.

[0130] The drug dispensing device 1 may detect a blockage in the flow path when the number of times the pressure of the drug solution reaches a predetermined reference pressure value exceeds a predetermined reference number. Therefore, the drug dispensing device 1 can accurately detect a true blockage while preventing false detections.

[0131] Furthermore, in this embodiment, the drug dispensing device 1 acquires the pressure of the drug solution in the flow path based on the rotation sensor value acquired by the rotation sensor 76, but the configuration by which the drug dispensing device 1 acquires the pressure in the flow path is not limited to this. For example, the drug dispensing device 1 may be equipped with a force sensor for detecting the pressure in the reservoir 18, for example, on the plunger 20. The force sensor is, for example, a load cell, but may be implemented with any sensor. When a force sensor is used, after stopping the fluid supply in step S12 in Figure 14B, the drug dispensing device 1 may, in steps S13 and S14, restart the fluid supply in accordance with the passage of a certain amount of time, or restart the fluid supply in accordance with the detected pressure falling below a predetermined threshold. Similarly, in steps S34 and S35 in Figure 15B, the drug dispensing device 1 may, after stopping the fluid supply, restart the fluid supply in accordance with the detected pressure falling below a predetermined threshold.

[0132] The pump body 10 also includes a plunger 20, a nut portion 24, and a drive unit 40. The plunger 20 is located inside the reservoir 18 and is movable in the longitudinal direction of the reservoir 18. The nut portion 24 moves within its movable range, engaging with the plunger 20 and pressing the plunger 20 toward the front end of the reservoir 18. The drive unit 40 moves the nut portion 24 within its movable range. The drive unit 40 includes a motor 44, a gearbox 46, and a rotation sensor 76. The motor 44 provides rotational drive. The gearbox 46 transmits the rotational driving force of the motor 44 as a driving force to move the nut portion 24 within its movable range. The rotation sensor 76 detects a rotation sensor value related to the rotational speed of the rotating body 78 connected to the motor 44 when a drive signal to rotate the motor 44 by one rotation is output. The control unit 71 acquires the rotation sensor value detected by the rotation sensor 76 as a value related to the pressure of the chemical solution in the flow path.

[0133] The drug dispensing device 1 acquires the rotation sensor value detected by the rotation sensor 76 as a value related to the pressure of the drug solution in the flow path, making it possible to detect blockages in the flow path based on the rotation sensor value.

[0134] The drug dispensing device 1 may detect an obstruction in the flow path when the number of times the rotation sensor value reaches a predetermined reference value exceeds a predetermined number of times. The drug dispensing device 1 may also detect an obstruction in the flow path when the number of times the rotation sensor value that reaches the reference value among the most recently acquired predetermined rotation sensor values ​​exceeds a predetermined number of times. The drug dispensing device 1 may output an alarm from its output unit in response to detecting an obstruction in the flow path. For example, the drug dispensing device 1 may output an alarm from the notification unit 77 and the output unit 95 of the controller 90.

[0135] This disclosure is not limited to the embodiments described above. For example, multiple blocks shown in a block diagram may be combined, or a single block may be divided. Multiple steps shown in a flowchart may be performed in parallel or in a different order, depending on the processing capacity of the device performing each step, or as necessary, instead of being performed in chronological order as described. Other modifications are possible without departing from the spirit of this disclosure.

[0136] 1. Drug dispensing device 10. Pump body 11. Cradle device 12. Cartridge 14. Device body 16. Base part 18. Reservoir 20. Plunger 22. Lead screw shaft 24. Nut part 26. Inlet port 28. Outlet port 29. Outlet tube 30. Plunger body 32. Pusher 34. Seal member 36. Extension part 38. Claw part 39. Bearing 40. Drive unit 42. Rechargeable battery 44. Motor 46. Gearbox 48. Output gear 50. Spur gear 52. Transmission shaft 54. Terminal 56. Bearing 58. Nut part body 60. Slide part 62. Screw hole 64. Through hole 66. Reinforcement cover 68. Guide wall 71. Control unit 72. Memory unit 73. Communication unit 74. Charging circuit unit 75. Connector unit 76. Rotation sensor 77 Notification unit 78 Rotating body 781 Rotating body main body 782 Shielding plate 783 Shaft part 784 Slit 79 Bus 106 Cannula report 111 Housing 112 Connecting needle tube 117 Opening 118 Inner wall 119 Projection 121 Top surface 122 Bottom surface 123 Front surface 124 Rear surface 125 First side surface 126 Second side surface 127 Bottom storage section 127a Wall surface 128 Connection port 128a Cylindrical hole 131 Fitting projection 132 Sliding groove 133 Mounting detection switch 134 Detection groove 135 First guide groove 136 First engagement hook 137 Second guide groove 138 Second engagement hook 141 Mounting surface 143 Side wall portion 144 Side wall portion 151 Guide rail 152 Detection rail 153 Sliding rail 154 Fitting hole 155 Mounting portion 156 Posture correction portion 158 Notch 162 Engagement receiving portion181 Port body 182 Cap 90 Controller 91 Control unit 92 Memory unit 93 Communication unit 94 Input unit 95 Output unit 99 Bus 100 Drug administration system 201-203 Graph 211 Graph 251 Graph 252 Symbol 253 Graph

Claims

1. A drug dispensing device comprising a pump body for dispensing a drug solution filled in a reservoir, wherein the pump body comprises a pump for transferring the drug solution filled in the reservoir, and a control unit, the control unit repeats, during the transfer of the drug solution by the pump, a first operation in which the transfer of the drug solution by the pump is stopped when the pressure of the drug solution in the flow path leading the drug solution out of the reservoir reaches a predetermined reference pressure value, and a second operation in which the transfer of the drug solution is resumed after a predetermined period of time has elapsed since the transfer of the drug solution was stopped, until a predetermined amount of the drug solution has been transferred.

2. The pump body comprises a plunger provided in the reservoir and movable in the longitudinal direction of the reservoir; a movable part that moves within a movable region to engage with the plunger and press the plunger toward the tip of the reservoir; a drive unit that moves the movable part within the movable region, the drive unit comprising a motor that rotates; a power transmission mechanism that transmits the rotational driving force of the motor as a driving force for moving the movable part within the movable region; a rotation detection unit that detects a rotation sensor value relating to the rotational speed of a rotating body connected to the motor when a drive signal for one rotation is output to the motor, the control unit acquires the rotation sensor value detected by the rotation detection unit as a value relating to the pressure of the drug solution in the flow path, the drug solution dispensing device according to claim 1.

3. The drug dispensing device according to claim 2, wherein the control unit detects an obstruction in the flow path when the number of times the rotation sensor value reaches a predetermined reference value exceeds a predetermined reference number.

4. The drug dispensing device according to claim 3, wherein the control unit detects an obstruction in the flow path when the number of rotation sensor values ​​that have reached the reference value among a predetermined number of rotation sensor values ​​acquired most recently exceeds the reference number.

5. The drug dispensing device according to any one of claims 1 to 4, wherein the control unit causes the output unit to output an alarm in response to the detection of an obstruction in the flow path.

6. A method for controlling a drug dispensing device comprising a pump body for dispensing a drug solution filled in a reservoir, wherein the pump body comprises a pump for transferring the drug solution filled in the reservoir, and a control unit, and the control unit includes repeating a first operation in which, during the transfer of the drug solution by the pump, the pressure of the drug solution in the channel leading the drug solution out of the reservoir reaches a predetermined reference pressure value, and a second operation in which, after a predetermined period of time has elapsed since the transfer of the drug solution was stopped, the transfer of the drug solution is resumed until a predetermined amount of the drug solution has been transferred.

7. A program for controlling a drug dispensing device comprising a pump body for dispensing a drug solution filled in a reservoir, wherein the pump body comprises: a pump for transferring the drug solution filled in the reservoir; a detection unit for detecting the pressure of the drug solution in a channel leading the drug solution out of the reservoir; and a control unit, the program causing the control unit to execute a procedure that repeats until a predetermined amount of the drug solution has been transferred: a first operation to stop the transfer of the drug solution by the pump when the pressure of the drug solution in the channel leading the drug solution out of the reservoir reaches a predetermined reference pressure value; and a second operation to resume the transfer of the drug solution after a predetermined period of time has elapsed since the transfer of the drug solution was stopped.

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