Drug dispensing device and control method thereof, and drug dispensing system
The drug delivery device addresses bubble removal inefficiencies by using a control unit to manage the plunger and refill the flow path, ensuring complete drug delivery and preventing complications.
Patent Information
- Application Number
- JP2024504391
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2022-03-01
- Filing Date
- 2023-01-13
- Publication Date
- 2026-08-26
- Estimated Expiration
- 2043-01-13
AI Technical Summary
Conventional chemical solution administration devices fail to effectively remove bubbles that form during administration, leading to incomplete drug delivery and potential health issues like hyperglycemia.
A drug delivery device with a control unit that moves a movable part to secure a larger volume in the reservoir, allowing for effective removal of air bubbles by retracting the plunger and refilling the flow path with drug solution, aided by a remote control for user operation.
Effectively removes air bubbles during drug administration, ensuring complete delivery and preventing health complications.
Smart Images

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Abstract
Description
Technical Field
[0001] The present disclosure relates to a chemical solution administration device, a control method thereof, and a chemical solution administration system.
Background Art
[0002] There is known a chemical solution administration device that continuously or intermittently administers a chemical solution such as insulin filled in a reservoir (syringe) into a living body by the pressing action of a plunger via a nut portion (for example, Patent Document 1).
Prior Art Documents
Patent Documents
[0003]
Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0004] After the start of chemical solution administration, bubbles may be found in the reservoir 18 for some reason. If the chemical solution administration device administers the chemical solution into the living body with the bubbles mixed in, the planned amount of the chemical solution may not be injected into the patient, and the patient may develop hyperglycemia or the like. Therefore, when bubbles are found, the user needs to interrupt the chemical solution administration and remove the bubbles.
[0005] However, in the conventional configuration, there is room for improvement in removing the bubbles found after the start of chemical solution administration.
[0006] An object of the present disclosure is to provide a chemical solution administration device, a control method thereof, and a chemical solution administration system capable of more effectively removing the bubbles found after the start of chemical solution administration.
Means for Solving the Problems
[0007] The chemical solution administration device according to an embodiment of the present disclosure is (1) A drug delivery device for administering a drug solution filled in a reservoir into a living body by the pressing action of a plunger, comprising: a reservoir filled with the drug solution; a channel connected to the reservoir and for guiding the drug solution out of the reservoir; a plunger provided in the reservoir and movable in the longitudinal direction of the reservoir; a movable part that moves within a movable range to connect with the plunger and press the plunger toward the tip side of the reservoir; a drive unit for moving the movable part within the movable range; and control The control unit comprises a movable part and a plunger, and when the drug administration is interrupted while the movable part is connected to the plunger and is administering the drug solution into the living body by pressing on the plunger, the control unit controls the drive unit to move the movable part by a predetermined distance to the base end of the reservoir in response to a first operation by the user, and after the movable part has moved by the predetermined distance to the base end of the reservoir, when an operation is performed to remove air bubbles from the reservoir, the control unit starts a process to fill the flow path with the drug solution.
[0008] As one embodiment, (2) In the drug administration device of (1), If the drug administration is interrupted, the control unit may, in response to the user's first operation, move the movable part toward the base end of the reservoir by a predetermined distance, such predetermined distance, to secure a volume in the reservoir that is larger than the volume in the flow path.
[0009] As one embodiment, (3) In the drug administration device of (1) or (2), The control unit may, in response to the user's first operation, move the movable part toward the base end of the reservoir by a predetermined distance at a first speed, and then, when an operation to remove air bubbles from the reservoir is performed, move the movable part toward the tip of the reservoir by a predetermined distance at a first speed, and further, while the user's second operation is being performed, move the movable part toward the tip of the reservoir at a second speed.
[0010] As one embodiment, (4)(3) In the drug administration device, The first speed may be faster than the second speed.
[0011] As one embodiment, (5) In any of the drug administration devices described in (1) to (4), The system further comprises a pump body housing the reservoir, the flow path, the plunger, the movable part, the drive unit, and the control unit; a cradle device having a structure that engages with and is detachable from the pump body and can be attached to the patient's skin; and a detection unit that detects whether or not the pump body is mounted on the cradle device. The control unit may determine that drug administration has been interrupted when the detection unit detects that the pump body has been removed from the cradle device.
[0012] As one embodiment, (6) In any of the drug administration devices described in (1) to (5), The control unit may start the process of filling the flow path with the chemical solution after the movable part has moved toward the base end of the reservoir by the predetermined distance, and the user has notified the control unit that an operation to remove air bubbles from the reservoir has been performed.
[0013] As one embodiment, (7) In any of the drug administration devices described in (1) to (5), The control unit may start the process of filling the flow path with the chemical solution after the movable part has moved toward the base end of the reservoir by the predetermined distance, and an operation to remove air bubbles from the reservoir has been performed by an external device.
[0014] A drug administration system according to one embodiment of the present disclosure is (8) The device comprises a drug dispensing device according to any of (1) to (7), and a remote control for the user to operate the drug dispensing device.
[0015] A control method for a drug solution dispensing device according to one embodiment of this disclosure is: (9) A control method for administering a drug solution, comprising: a reservoir filled with a drug solution; a channel connected to the reservoir and for guiding the drug solution out of the reservoir; a plunger provided in the reservoir and movable in the longitudinal direction of the reservoir; a movable part that moves within a movable range to connect with the plunger and press the plunger toward the tip of the reservoir; a drive unit for moving the movable part within the movable range; and a control unit, wherein the drug solution filled in the reservoir is administered into a living body by the pressing action of the plunger. The control unit includes the steps of: controlling the drive unit so that, in response to a first operation by the user, the movable part moves toward the base end of the reservoir by a predetermined distance when the drug administration is interrupted while the movable part is connected to the plunger and the drug solution is being administered into the living body by pressing on the plunger; and starting a process to fill the flow path with the drug solution after the movable part has moved toward the base end of the reservoir by the predetermined distance and an operation to remove air bubbles from the reservoir has been performed. [Effects of the Invention]
[0016] According to one embodiment of the present disclosure, it is possible to more effectively remove air bubbles found after the start of drug administration. [Brief explanation of the drawing]
[0017] [Figure 1] It is a diagram showing an example of a chemical solution administration system according to an embodiment. [Figure 2] It is an example of a perspective view of the chemical solution administration device in FIG. 1. [Figure 3] It is an example of a perspective view in which the chemical solution administration device in FIG. 1 is in a separated state. [Figure 4] It is an example of an exploded perspective view of the pump body in FIG. 3. [Figure 5] It is a diagram showing an example of a cartridge in a state where the nut portion is in a non-contact position. [Figure 6] It is a diagram showing an example of a cartridge in a state where the nut portion is in a predetermined position. [Figure 7] It is a block diagram showing an example of a configuration related to the control of the chemical solution administration device in FIG. 1. [Figure 8] It is a block diagram showing an example of the hardware configuration of the remote controller in FIG. 1. [Figure 9] It is a flowchart showing the operation procedure of the chemical solution administration device according to an embodiment. [Figure 10] It is a schematic diagram showing an example of the pump body and the in-flight cradle. [Figure 11] It is a block diagram showing an example of the hardware configuration of the in-flight cradle in FIG. 10. [Figure 12] It is a flowchart showing the operation procedure of the chemical solution administration device according to an embodiment. [Figure 13] It is a flowchart showing the operation procedure of the in-flight cradle according to an embodiment.
MODE FOR CARRYING OUT THE INVENTION
[0018] 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, duplicate descriptions of the same parts may be omitted or simplified as appropriate.
[0019] (Configuration of Chemical Solution Administration System) Figure 1 shows 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 remote control 90.
[0020] As will be described later with reference to Figure 4, the drug administration device 1 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, for example.
[0021] The remote control 90 is a device for a user, such as a patient, to operate the drug administration device 1. The remote control 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 remote control 90 is implemented by a dedicated device corresponding to the drug administration device 1, but it may also be implemented by a general-purpose information processing device such as a smartphone or tablet. Furthermore, in this embodiment, an example is described in which the remote control 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.
[0022] The drug dispensing device 1 and the remote control 90 are connected to each other via a wireless communication line, a wired communication line, or a combination thereof. The following describes an example in which the drug dispensing device 1 and the remote control 90 are connected via Bluetooth®.
[0023] (Configuration of the drug administration device) Figure 2 is an example of a perspective view of the drug dispensing device 1 shown in Figure 1. Figure 3 is an example of a perspective view of the drug dispensing device 1 shown in Figure 1 when it is separated. The drug dispensing device 1 has a pump body 10, a cradle device 11 to which the pump body 10 is detachably mounted, and a connection port 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.
[0024] 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 top 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 top surface 121 may be formed in a substantially rectangular shape with curved corners when viewed from above. At the first end of the top 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 top surface 121, a side surface 126 is continuously connected substantially vertically.
[0025] As shown in Figure 3, the pump body 10 may have a reusable engagement structure on its side surface 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, a guide groove 137 and an engagement hook 138 may be formed on the side surface 126. The engagement hook 138 may be formed closer to the rear surface 124 than the guide groove 137. The engagement hook 138 may be reusably engaged with an engagement receiving portion 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 141 and side walls 143 and 144. The mounting surface 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 of the housing 111 of the pump body 10 is placed on the mounting surface 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 connection port 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 connection port 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 a detection groove provided in the pump body 10 and presses against the mounting detection unit 75. The pump body 10 detects that the cradle device 11 is mounted based on the pressure on the mounting detection unit 75. In other words, the mounting detection unit 75 functions as a detection unit that detects 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, a sliding groove (not shown) provided on the bottom surface 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 approximately vertically. Two opposing side wall portions 143 are continuously attached to the end of the mounting surface portion 141 in a second direction, extending approximately vertically. When the pump body 10 is mounted on the cradle device 11, the side wall portion 143 faces the 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 provided on the front portion 123 of the pump body 10 may fit into the fitting hole 154.
[0032] A guide rail 151, a posture correction section 156, and an engagement receiving section 162 may be formed on the side wall 143. The engagement receiving section 162 may be an opening cut out in a substantially rectangular shape from the side wall 143. When the pump body 10 is mounted on the cradle device 11, an engagement hook section 138 may be detachably engaged with the engagement receiving section 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 have 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. When the pump body 10 is mounted on the cradle device 11, the guide rail 151 engages with a guide groove portion 137 provided on the 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 top surface portion 121 and the side surface portion 126 of the housing 111 of the pump body 10.
[0035] The cradle device 11 may be provided with an adhesive sheet that is 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 (not shown) through which the cannula of the connection port 106, described later, passes. 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 is 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 connection port 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 hole), 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 connection port 106 is isolated from the external environment.
[0037] When the connection port 106 is attached to the mounting portion 155 of the cradle device 11 using a puncture mechanism (not shown), the cannula, together with the puncture needle, penetrates the mounting surface portion 141 and protrudes to the other side of the mounting surface portion 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 upstream in the mounting direction. The connecting needle tube, which is exposed to the outside of the pump body 10, is fluidly connected to the outlet tube 29. The connecting needle tube 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 5, 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 connection port 106 via the outlet tube 29 and administered to the patient through the cannula when the drive unit 40 (see Figure 5, etc.) is driven. In other words, the outlet tube 29 is connected to the reservoir 18 and acts as a flow path for guiding the drug solution out of the reservoir 18. When the connecting needle tube is connected to the outlet tube 29, the flow path of the drug solution administration device 1 may include the outlet tube 29 and the connecting needle tube.
[0039] (Pump body configuration) Figure 4 is an example of an exploded perspective view of the pump body 10 shown in Figure 3. Figure 5 shows an example of the cartridge 12 with the nut portion 24 in a non-contact position. Figure 6 shows an example of the cartridge 12 with the nut portion 24 in a predetermined position.
[0040] As shown in Figure 4, the pump body 10 comprises a disposable cartridge 12 and a reusable device body 14. The cartridge 12 has a flat, box-shaped base portion 16 with one side open. The base portion 16 has a substantially rectangular shape in plan view. The base portion 16 may be detachably attached to a cradle device 11 that can be attached to the patient's skin.
[0041] As shown in Figure 4, the base portion 16 is provided with a reservoir 18 filled with a chemical solution, a plunger 20 located inside the reservoir 18, a feed screw shaft 22 arranged coaxially with the plunger 20, and a nut portion (movable part) 24 screwed onto the feed screw shaft 22. The base portion 16 is constructed as a disposable component.
[0042] The reservoir 18 extends cylindrically in the longitudinal direction of the base portion 16. The tip of the reservoir 18 has an outer diameter and an inner diameter that narrows towards the tip. At the tip of the reservoir 18, an introduction port 26 for introducing the drug solution into the reservoir 18 and an outlet port 28 (see Figure 5) for discharging the drug solution from the reservoir 18 are formed. An outlet tube 29 for guiding the drug solution from the reservoir 18 to the cannula is connected to the outlet port 28.
[0043] As shown in Figure 5, 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 chemical solution 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 is not limited to this as long as it can prevent the chemical solution in the reservoir 18 from leaking out of the plunger body 30. The sealing member 34 may be made of an elastic material, for example, silicone rubber.
[0044] 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.
[0045] The drive unit 40 further includes a battery 42 as a power source, a motor 44 driven by the 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.
[0046] In this embodiment, the battery 42 and transmission shaft 52 are provided in the cartridge 12, and the motor 44 and gearbox 46 are provided in the device body 14. By providing the motor 44 and gearbox 46 in the device body 14 in this way, the cost of the cartridge 12 can be reduced.
[0047] The 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.
[0048] 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 or 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 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, etc., 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.
[0049] 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.
[0050] 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 5), 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 feed screw shaft 22. After contacting the plunger 20, the nut portion 24 presses the plunger 20 toward the tip as the feed screw shaft 22 rotates further (see Figure 6). 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.
[0051] As shown in Figures 4 to 6, 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 the battery 42, motor 44, storage unit 72, and communication unit 73 via a bus 79 (see Figure 7). The control unit 71 controls each part of the drug dispensing device 1 and performs processing 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 remote control 90.
[0052] Figure 7 is a block diagram showing an example of the configuration for controlling the drug administration device 1 shown in Figure 1. As mentioned above, the control unit 71 is electrically connected to the battery 42, motor 44, memory unit 72, communication unit 73, and mounting detection unit 75 via the bus 79.
[0053] The control unit 71 is one or more processors. The control unit 71 is communicatively connected to each component constituting the drug dispensing device 1 and controls the operation of the entire drug 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).
[0054] 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 remote control 90 via the communication unit 73 under the control of the control unit 71.
[0055] The communication unit 73 is a communication interface for communicating with the remote control 90. In this embodiment, the communication unit 73 communicates with the remote control 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.
[0056] The mounting detection unit 75 consists of a mechanical switch or the like that is pressed when the pump body 10 is mounted on the cradle device 11, and transmits information to the control unit 71 about whether or not the pump body 10 is mounted on the cradle device 11.
[0057] 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.
[0058] (Remote control configuration) Figure 8 is a block diagram showing an example of the hardware configuration of the remote control 90 shown in Figure 1. The remote control 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.
[0059] The control unit 91 is one or more processors. The control unit 91 is communicated with each component constituting the remote control 90 via the bus 99 and controls the operation of the entire remote control 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. The dedicated circuit is, for example, an FPGA.
[0060] 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 main memory, auxiliary memory, or cache memory.
[0061] 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 by wired cables.
[0062] 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.
[0063] The output unit 95, which functions as a display unit, 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 that outputs information by image display, an LED (Light Emitting Diode), a speaker, or a vibrator, but is not limited to these. The input unit 94 and the output unit 95 function as an input / output unit, which is an interface between the user and the drug dispensing device 1. In this embodiment, an example is described in which such an input / output unit is provided on the remote control 90, but it may also be provided on the drug dispensing device 1 or other devices.
[0064] The functions of the remote control 90 may be implemented by executing the program according to this embodiment on a processor included in the control unit 91. In other words, the functions of the remote control 90 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 remote control 90, thereby enabling the computer to implement the functions corresponding to the processing of those steps. Alternatively, some or all of the functions of the remote control 90 may be implemented by a dedicated circuit included in the control unit 91. In other words, some or all of the functions of the remote control 90 may be implemented by hardware.
[0065] (Operation of the drug administration device) To operate the drug dispensing device 1 according to this embodiment, the user first 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 5).
[0066] 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 to the cartridge 12. As a result, power from the 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 battery 42.
[0067] 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 remote control 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.
[0068] 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 from their bent state to their original state, and the nut portion 24 is locked against the rear end of the plunger 20. This allows the nut portion 24 to 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 outlet 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, which is fluidically connected to the outlet tube 29 and exposed to the outside of the drug solution dispensing device 1. When the user visually confirms that the drug solution has been discharged from the connecting needle tube, they instruct the drug solution dispensing device 1 to stop priming. For example, the remote control 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, it may notify the drug dispensing device 1 that the motor 44 has been stopped.
[0069] Next, the user attaches the cradle device 11 to a designated position on the skin, uses the puncture mechanism to insert the cannula of the connection port 106 into the body, and locks the connection port 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 from the remote control 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.
[0070] 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 reservoir 18 of the cartridge 12 is filled with drug solution, 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.
[0071] 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, an adult cartridge 12 will be filled with more medication than a pediatric cartridge 12.
[0072] After performing the priming operation described above, air bubbles may be discovered in the reservoir 18 for some reason while the pump body 10 is attached to the cradle device 11 and the drug solution is being administered to the patient. For example, air dissolved in the drug solution, air in the reservoir 18 that was overlooked during drug solution filling, or air that has permeated the outer wall of the reservoir 18 may accumulate in the reservoir 18 and form air bubbles. In such cases, if the drug administration device 1 administers the drug solution into the body with air bubbles present, the intended amount of drug solution may not be injected into the patient, and the patient may develop hyperglycemia or other problems. Therefore, if air bubbles are found, the user may temporarily stop the drug solution administration, remove the pump body 10 from the cradle device 11, and then perform an operation to remove the air bubbles from the reservoir 18.
[0073] To remove air bubbles, the user grasps the pump body 10 so that the tip of the reservoir 18 faces vertically upward, and lightly taps the reservoir 18 with their finger to collect the air bubbles at the tip of the reservoir 18. Then, the user operates the remote control 90 to rotate the motor 44 in a direction that moves the nut portion 24, which is locked to the plunger 20, toward the tip of the reservoir 18. The user pushes up the plunger 32 to expel the air bubbles until the liquid comes out of the connecting needle tube on the back of the cartridge 12, and once the discharge of the liquid is visually confirmed, the user operates the remote control 90 to stop the motor 44. As a result, the air bubbles in the reservoir 18 are removed, and the reservoir 18 is filled with liquid until the outlet tube 29 is filled.
[0074] However, if drug administration is stopped during drug administration, some drug solution may remain in the outlet tube 29. In such cases, the user may mistakenly believe that the removal of air bubbles is complete simply because the drug solution remaining in the outlet tube 29 has been released, even though air bubbles actually remain in the reservoir 18. Therefore, in conventional drug administration devices, there was a possibility that drug administration would be restarted without sufficient removal of air bubbles. Thus, in the conventional configuration, there was room for improvement in removing air bubbles found after the start of drug administration.
[0075] In this embodiment, if the pump body 10 is removed from the cradle device 11 during drug dispensing, the drug dispensing device 1 rotates the motor 44 by a certain number of rotations M in the direction that moves the nut portion 24, which is locked to the plunger 20, toward the base end of the reservoir 18. As a result, the drug dispensing device 1 draws back the drug solution and air remaining in the outlet pipe 29 into the reservoir 18. Then, the drug dispensing device 1 instructs the user to grasp the pump body 10 so that the tip of the reservoir 18 is facing vertically upward, and to lightly tap the reservoir 18 with their finger to collect air bubbles at the tip of the reservoir 18. Once the user has finished collecting the air bubbles, the drug dispensing device 1 rotates the motor 44 by a certain number of rotations M in the direction that moves the nut portion 24 toward the tip of the reservoir 18. Furthermore, the drug dispensing device 1 rotates the motor 44 in the direction that moves the nut portion 24 toward the tip of the reservoir 18 only while instructed by the user via the remote control 90. When the user visually confirms the discharge of the drug solution, they operate the remote control 90 to stop the motor 44. This fills the flow path of the drug solution dispensing device 1, including the outlet pipe 29, with the drug solution, allowing the user to attach the pump body 10 to the cartridge 12 and resume drug solution dispensing to the drug solution dispensing device 1. In this way, the drug solution dispensing device 1 automatically draws back the drug solution and air remaining in the outlet pipe 29 into the reservoir 18, allows the user to remove air bubbles, and then performs the operation to fill the flow path of the drug solution dispensing device 1 with the drug solution. Therefore, the drug solution dispensing device 1 according to this embodiment can more effectively remove air bubbles found after the start of drug solution dispensing.
[0076] Figure 9 is a flowchart showing the operation procedure of the drug dispensing device 1 in Figure 1. The operation of the drug dispensing device 1 described with reference to Figure 9 may correspond to one of the control methods for the drug dispensing device 1. The operation of each step in Figure 9 may be performed based on control by the control unit 71 of the drug dispensing device 1. Below, we will describe an example in which, after the priming operation has been performed and the pump body 10 is attached to the cradle device 11 and the drug is being dispensed, the user discovers air bubbles in the reservoir 18 when the pump body 10 is removed from the cradle device 11, for example, for bathing, and performs an operation to remove the air bubbles. First, when the user operates the remote control 90 and instructs to perform air bubble removal via the input unit 94, the control unit 91 notifies the control unit 71 of the pump body 10 of this.
[0077] In step S1, the control unit 71 determines whether the pump body 10 has been removed from the cradle device 11. The control unit 71 may, for example, detect whether the cradle device 11 is installed by detecting whether the detection rail 152 of the cradle device 11 has entered the detection groove provided in the pump body 10 and pressed against the installation detection unit 75. If the pump body 10 has been removed from the cradle device 11 (YES in step S1), the control unit 71 proceeds to step S2; otherwise (NO in step S1), it waits until the pump body 10 is removed from the cradle device 11.
[0078] In step S2, the control unit 71 displays an image of a button (first button) on the display of the output unit 95 in a selectable manner, and displays a message such as "Maintenance work will be performed. Please press the first button," to inform the user to select the first button. If the drug dispensing device 1 is equipped with an output unit and an input unit, the control unit 71 may also display an image of a button on the display of the output unit of the drug dispensing device 1 in a selectable manner to inform the user to select the first button. Furthermore, if the remote control 90 or the drug dispensing device 1 is equipped with a mechanical button or other operating part, the control unit 71 may also inform the user to select that operating part as the first button. In step S2, the control unit 91 may also inform the user to select the first button.
[0079] In step S3, the control unit 71 determines whether the first button has been selected by the user. If it has been selected (YES in step S3), the control unit 71 proceeds to step S4; otherwise (NO in step S3), it continues the process in step S3 until the first button is selected. In step S3, the control unit 91 may also determine whether the first button has been selected by the user.
[0080] In step S4, the control unit 71 rotates the motor 44 at a first rotational speed by a certain number of rotations M in the direction that moves the nut portion 24 toward the base end of the reservoir 18 (reverse rotation). As a result, the nut portion 24 moves toward the base end of the reservoir 18 at the first speed. Since the nut portion 24 is locked to the plunger 20, the reverse rotation of the motor 44 pulls the plunger 20 back toward the base end of the reservoir 18. The rotational speed M is the number of rotations corresponding to the distance the plunger 20 moves to secure a volume in the reservoir 18 that is larger than the volume in the outlet tube 29. Therefore, the drug dispensing device 1 can draw back the drug solution and air remaining in the outlet tube 29 into the reservoir 18 by the reverse rotation of the motor 44. By setting the first rotational speed to a sufficiently fast speed (for example, the maximum rotational speed of the motor 44), the drug solution and air remaining in the outlet tube 29 can be drawn back quickly, reducing the user's waiting time.
[0081] In step S5, the control unit 71 selectively displays an image of a button (second button) on the display of the output unit 95. Furthermore, the control unit 71 displays a message such as, "Hold the pump vertically, flick the reservoir part several times from the outside with your finger, and then press the second button," informing the user to select the second button after removing the air bubbles. If the drug dispensing device 1 has an output unit and an input unit, the control unit 71 may selectively display an image of a button on the display of the output unit of the drug dispensing device 1 to instruct the user to select the second button. Also, if the remote control 90 or the drug dispensing device 1 has a mechanical button or other operating part, the control unit 71 may instruct the user to select that operating part as the second button. In addition, if the drug dispensing device 1 is equipped with a posture sensor and an acceleration sensor, these sensors may be used to detect that the pump body 10 is gripped so that the tip of the reservoir 18 is facing vertically upward, and that the reservoir 18 has been flicked with a finger. If these are detected, the drug dispensing device 1 may proceed to step S7 without confirming the selection of the second button. In step S5, the control unit 91 may inform the user to select the second button.
[0082] In step S6, the control unit 71 determines whether the second button has been selected by the user. If it has been selected (YES in step S6), the control unit 71 proceeds to step S7; otherwise (NO in step S6), it continues the process in step S6 until the second button is selected. In step S6, the control unit 91 may also determine whether the second button has been selected.
[0083] In step S7, the control unit 71 rotates the motor 44 at a first rotational speed by a certain number of rotations M in the direction that moves the nut portion 24 toward the tip of the reservoir 18 (forward rotation). As a result, the nut portion 24 moves toward the tip of the reservoir 18 at the first speed. Since the forward rotation speed M in step S7 is the same as the reverse rotation speed in step S4, the forward rotation of the motor 44 returns the plunger 20 to the position it was in when drug administration was interrupted.
[0084] In step S8, the control unit 71 displays an image of a button (dispensing button) on the display of the output unit 95 in a selectable manner, and displays a message such as "Please press the dispensing button until the drug solution is dispensed from the connecting needle tube," informing the user to select the dispensing button until the drug solution is dispensed. If the drug solution dispensing device 1 has an output unit and an input unit, the control unit 71 may display an image of a button on the display of the output unit of the drug solution dispensing device 1 in a selectable manner, informing the user to select the dispensing button. Also, if the remote control 90 or the drug solution dispensing device 1 has an operating part such as a mechanical button, the control unit 71 may instruct the user to select that operating part as the dispensing button. In step S8, the control unit 91 may instruct the user to select the dispensing button until the drug solution is dispensed.
[0085] In step S9, the control unit 71 determines whether the user has selected the fluid dispensing button. If the user has selected the button (YES in step S9), the control unit 71 proceeds to step S10; otherwise, if the user has not selected the button (NO in step S9), it continues the process in step S9 until the user selects the fluid dispensing button. In step S9, the control unit 91 may also determine whether the user has selected the fluid dispensing button.
[0086] In step S10, the control unit 71 rotates the motor 44 at a second rotational speed in the direction that moves the nut portion 24 toward the tip of the reservoir 18 (forward rotation). As a result, the nut portion 24 moves toward the tip of the reservoir 18 at a second speed. The second rotational speed may be slower than the first rotational speed. That is, the first speed may be faster than the second speed. The user selects buttons, etc., until the drug solution is discharged from the connecting needle tube. For example, the second rotational speed may be set so that a large amount of drug solution does not flow out if the user stops selecting buttons, etc., after visually confirming that the drug solution has been discharged from the connecting needle tube. However, the second rotational speed may be fast enough to shorten the time from when the user starts selecting buttons, etc., until the drug solution is discharged from the connecting needle tube. By setting the second rotational speed to a slower speed than the first rotational speed, even if the user visually confirms that the drug solution has been discharged from the connecting needle tube and then takes action to stop the nut section 24 from moving forward, it is possible to prevent a large amount of drug solution from leaking out.
[0087] In step S11, the control unit 71 determines whether the user has selected the liquid dispensing button. If the user has selected the button (YES in step S11), the control unit 71 continues the process in step S11 while continuing the rotation of the motor 44; otherwise, the process proceeds to step S12. In step S11, the control unit 91 may also determine whether the user has selected the liquid dispensing button.
[0088] In step S12, the control unit 71 stops the rotation of the motor 44. Then, the control unit 71 terminates the processing of the flowchart. As a result, the flow path of the drug administration device 1, including the outlet tube 29, is filled with drug solution, so the user can connect the pump body 10 to the cradle device 11 and resume drug administration.
[0089] As described above, the drug administration device 1 administers the drug solution filled in the reservoir 18 into the body by the pressing action of the plunger 20. The drug administration device 1 comprises a reservoir 18, a discharge tube 29, a plunger 20, a nut part 24, a drive unit 40, and a control unit 71. The reservoir 18 is filled with drug solution. The discharge tube 29 is connected to the reservoir 18 and discharges the drug solution to the outside of the reservoir 18. The plunger 20 is provided inside the reservoir 18 and is movable in the longitudinal direction of the reservoir 18. The nut part 24 moves within its movable range, connecting with the plunger 20 and allowing the plunger 20 to be pressed towards the tip of the reservoir 18. The drive unit 40 moves the nut part 24 within its movable range. The control unit 71 controls the drive unit 40 so that, in response to a first operation by the user (for example, selection of the first button), the nut portion 24 moves a predetermined distance toward the base end of the reservoir 18 if the drug administration is interrupted while the drug solution is being administered into the body by pressing the plunger 20 with the nut portion 24 connected to the plunger 20. Furthermore, after the nut portion 24 has moved a predetermined distance toward the base end of the reservoir 18, if an operation is performed to remove air bubbles from the reservoir 18, the control unit 71 starts the process of filling the outlet tube 29 with the drug solution.
[0090] In this way, the drug dispensing device 1 automatically draws back the drug solution remaining in the outlet tube 29 into the reservoir 18 in response to the user's first operation, and then, when an operation is performed to remove air bubbles from the reservoir 18, it starts the process of filling the outlet tube 29 with drug solution. Therefore, it is possible to reduce the possibility that the user may mistakenly believe that the removal of air bubbles is complete just because the drug solution remaining in the outlet tube 29 has come out, even though air bubbles actually remain in the reservoir 18. Thus, the drug dispensing device 1 can more effectively remove air bubbles found after the start of drug dispensing.
[0091] If drug administration is interrupted, the control unit 71 may, in response to the user's first operation, move the plunger 20 to the base end of the reservoir 18 by a predetermined distance to ensure that a volume greater than the volume in the outlet tube 29 is secured in the reservoir 18. Thus, by moving the nut portion 24 to the base end of the reservoir 18, the drug administration device 1 can draw back the drug solution remaining in the outlet tube 29 into the reservoir 18, making it possible to more effectively remove air bubbles found after the start of drug administration.
[0092] Furthermore, in response to a first operation by the user, the control unit 71 may move the nut portion 24 toward the base end of the reservoir 18 by a predetermined distance at a first speed, and then, when an operation to remove air bubbles from the reservoir 18 is performed, move the nut portion 24 toward the tip end of the reservoir 18 by a predetermined distance at a first speed. In addition, while the user is performing a second operation (for example, selecting the liquid dispensing button), the control unit 71 may move the nut portion 24 toward the tip end of the reservoir 18 at a second speed. In this way, when an operation to remove air bubbles from the reservoir 18 is performed, the drug dispensing device 1 automatically returns the nut portion 24 to the position it was in when drug dispensing was interrupted, and then advances the nut portion 24 only while the second operation is being performed, thereby reducing the time the user has to wait while performing the second operation until the drug is discharged.
[0093] Furthermore, the first speed may be faster than the second speed. Therefore, it is possible to quickly retract the nut portion 24 to draw back any remaining drug solution in the discharge tube 29 into the reservoir 18, or to advance the nut portion 24 to the position it was in when drug administration was interrupted. In addition, even if the user stops the second operation after visually confirming that the drug solution has been discharged from the connecting needle tube, it is possible to prevent a large amount of drug solution from flowing out.
[0094] The drug administration device 1 may also include a pump body 10, a cradle device 11, and a mounting detection unit 75. The pump body 10 may house a reservoir 18, an outlet tube 29, a plunger 20, a nut 24, a drive unit 40, and a control unit 71. The cradle device 11 has a structure that allows it to engage with and be attached to the pump body 10, and may be able to be attached to the patient's skin. The mounting detection unit 75 may detect whether or not the pump body 10 is mounted on the cradle device 11. The control unit 71 may determine that drug administration has been interrupted when the mounting detection unit 75 detects that the pump body 10 has been removed from the cradle device 11. In this way, by determining that drug administration has been interrupted when the pump body 10 is removed from the cradle device 11, it is possible to prevent the pump body 10 from continuing to fluidly connect with the cannula implanted in the body, thereby preventing the pump from starting the operation to draw back the drug solution remaining in the cannula 29 into the reservoir 18.
[0095] Furthermore, the control unit 71 may start the process of filling the outlet tube 29 with the chemical solution after the nut portion 24 has moved toward the base end of the reservoir 18 by a predetermined distance and the user has notified that an operation to remove air bubbles from inside the reservoir 18 has been performed. Therefore, it is possible to start the process of filling the outlet tube 29 with the chemical solution in response to the user completing the operation to remove air bubbles from inside the reservoir 18.
[0096] (Configuration with desktop cradle) In the example of operation described with reference to Figure 9, the drug dispensing device 1 had the user perform the air bubble removal operation, but the device may also perform air bubble removal automatically. Here, we will explain an example of removing air bubbles from the reservoir 18 using an external device, a desktop cradle.
[0097] Figure 10 is a schematic diagram showing an example of a pump body 10 and a desktop cradle 80. As shown in Figure 10, the desktop cradle 80 has an opening 89 on its top surface into which the pump body 10 can be inserted when placed on a horizontal surface. The opening 89 may have a shape that stably holds the pump body 10 while the tip of the reservoir 18 faces vertically upward. The desktop cradle 80 is equipped with an insertion detection unit 83 (see Figure 11) that detects when the pump body 10 is inserted into the opening 89. The desktop cradle 80 turns on the power of the device when the pump body 10 is inserted into the opening 89 and turns off the power when the pump body 10 is removed from the opening 89. The pump body 10 and the desktop cradle 80 may have electrode pins that contact each other when the pump body 10 is inserted into the opening 89, and the desktop cradle 80 connected to a power source may charge the battery 42 of the pump body 10 via these electrode pins.
[0098] Figure 11 is a block diagram showing an example of the hardware configuration of the desktop cradle 80 shown in Figure 10. The desktop cradle 80 comprises a control unit 81, a storage unit 82, an insertion detection unit 83, a microphone 84, a vibration unit 85, and a bus 88.
[0099] The control unit 81 is one or more processors. The control unit 81 is communicated with each component constituting the desktop cradle 80 via the bus 88 and controls the operation of the entire desktop cradle 80. 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 81 may include one or more dedicated circuits, or one or more processors in the control unit 81 may be replaced with one or more dedicated circuits. The dedicated circuit is, for example, an FPGA.
[0100] The storage unit 82 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 storage unit 82 functions, for example, as main memory, auxiliary memory, or cache memory.
[0101] The insertion detection unit 83 is a sensor that detects when the pump body 10 is inserted into the opening 89. The insertion detection unit 83 may also detect the installation of the pump body 10 based on the fact that when the pump body 10 is inserted into the opening 89, a part of the housing of the pump body 10 presses against the insertion detection unit 83.
[0102] Microphone 84 is a device that detects when sound is input. If the motor 44 of the drug dispensing device 1 is implemented as a stepping motor, a clicking sound will be emitted in accordance with the rotation of the motor 44. The desktop cradle 80 detects the rotation of the motor 44 based on the detection of such sound by microphone 84. The desktop cradle 80 may have any other configuration to detect the rotation of the motor 44. For example, it may have a communication unit that can communicate with the drug dispensing device 1 and obtain information on the operating status of the motor 44 from the drug dispensing device 1 via communication.
[0103] The vibration unit 85 is a device that applies vibration to the pump body 10 inserted into the opening 89. The vibration unit 85 may be configured, for example, as a vibrator device. The vibration unit 85 is used to collect and discharge bubbles vertically upward in the reservoir 18 by applying an impact to the pump body 10 that is equivalent to flicking it with a finger.
[0104] Figure 12 is a flowchart showing the operation procedure of a drug dispensing device 1 according to one embodiment. The operation of the drug dispensing device 1 described with reference to Figure 12 may correspond to one of the control methods for the drug dispensing device 1. The operation of each step in Figure 12 may be performed based on control by the control unit 71 of the drug dispensing device 1. Below, an example will be described in which, during drug dispensing, for example, when the pump body 10 is removed from the cradle device 11 for bathing, an air bubble is discovered in the reservoir 18 and an operation is performed to remove the air bubble is performed. First, when the user operates the remote control 90 and instructs to perform air bubble removal via the input unit 94, the control unit 91 notifies the control unit 71 of the pump body 10 of this.
[0105] In step S21, the control unit 71 determines whether the pump body 10 has been removed from the cradle device 11. The process in step S21 is the same as in step S1 in Figure 9. If the pump body 10 has been removed from the cradle device 11 (YES in step S21), the control unit 71 proceeds to step S22; otherwise (NO in step S21), it waits until the pump body 10 is removed from the cradle device 11.
[0106] In step S22, the control unit 71 displays an image of a button (first button) on the display of the output unit 95 in a selectable manner, and displays a message such as "Maintenance work will be performed. Insert the pump into the desktop cradle. After insertion, press the first button," informing the user to insert the pump body 10 into the desktop cradle 80 and select the first button. If the drug dispensing device 1 has an output unit and an input unit, the control unit 71 may display an image of a button on the display of the output unit of the drug dispensing device 1 in a selectable manner and informing the user to select the first button. Alternatively, if the remote control 90 or the drug dispensing device 1 has a mechanical button or other operating part, the control unit 71 may instruct the user to select that operating part as the first button. In step S22, the control unit 91 may also instruct the user to insert the pump body 10 into the desktop cradle 80 and select the first button.
[0107] In step S23, the control unit 71 determines whether the first button has been selected by the user. If it has been selected (YES in step S23), the control unit 71 proceeds to step S24; otherwise (NO in step S23), it continues the process in step S23 until the first button is selected. In step S23, the control unit 91 may also determine whether the first button has been selected by the user.
[0108] In step S24, the control unit 71 rotates the motor 44 at a first rotational speed by a certain number of rotations M in the direction that moves the nut portion 24 toward the base end of the reservoir 18 (reverse rotation). The process in step S24 is the same as in step S4 in Figure 9. As a result of the process in step S24, the drug dispensing device 1 can draw back the drug solution and air remaining in the outlet tube 29 into the reservoir 18.
[0109] In step S25, the control unit 71 determines whether a predetermined first hour has elapsed since the motor 44 finished rotating in the reverse direction in step S24. As will be described later, after detecting the insertion of the pump body 10, the desktop cradle 80 detects the operation of the motor 44 using the microphone 84 and automatically vibrates the pump body 10 with the vibration unit 85 for a certain period of time (second hour). In this way, the desktop cradle 80 vibrates the pump body 10 based on the operating sound of the motor 44 to collect air bubbles in the reservoir 18 towards the tip. The control unit 71 waits for a first hour which is longer than the second hour before performing the processing from step S26 onward, thereby removing the air bubbles and then performing the processing to fill the flow path of the drug solution dispensing device 1, including the outlet tube 29, with the drug solution.
[0110] In step S26, the control unit 71 rotates the motor 44 at a first rotational speed by a certain number of rotations M in the direction that moves the nut portion 24 toward the tip of the reservoir 18 (forward rotation). The process in step S26 is the same as in step S7 in Figure 9.
[0111] In step S27, the control unit 71 displays an image of a button (a liquid dispensing button) on the display of the output unit 95 in a selectable format, and also displays a message such as, "Remove the pump body from the desktop cradle and press the liquid dispensing button until the liquid is discharged from the connecting needle tube," informing the user to select the liquid dispensing button until the liquid is discharged. The method for presenting the liquid dispensing button is the same as in step S8 of Figure 9. In step S27, the control unit 91 may also inform the user to select the liquid dispensing button until the liquid is discharged.
[0112] The processing in steps S28 to S31 is the same as in steps S9 to S12 in Figure 9, so a detailed explanation is omitted. Once the control unit 71 has finished processing in step S31, it terminates the processing of the flowchart. As a result, the flow path of the drug administration device 1, including the outlet tube 29, is filled with drug solution, so the user can connect the pump body 10 to the cradle device 11 and resume drug solution administration.
[0113] Figure 13 is a flowchart showing the operation procedure of a desktop cradle 80 according to one embodiment. The operation of the desktop cradle 80 described with reference to Figure 13 may correspond to one of the control methods for the desktop cradle 80. The operation of each step in Figure 13 may be performed based on control by the control unit 81 of the desktop cradle 80.
[0114] In step S41, the control unit 81 determines whether the pump body 10 has been inserted into the opening 89 of the desktop cradle 80. The control unit 81 may determine whether the pump body 10 has been inserted based, for example, on the detection result of the insertion detection unit 83. If the pump body 10 has been inserted (YES in step S41), the control unit 81 proceeds to step S42; otherwise (NO in step S41), it continues the process of step S41 until the pump body 10 is inserted.
[0115] In step S42, the control unit 81 turns on the power to the desktop cradle 80.
[0116] In step S43, the control unit 81 determines whether or not it has detected the rotation sound of the motor 44 of the pump body 10 from the start to the end of its rotation using the microphone 84. This rotation sound of the motor 44 is the sound of the motor 44 rotating in the reverse direction in step S24 of Figure 12. That is, in step S43, the control unit 81 waits until the reverse rotation of the motor 44 in step S24 of Figure 12 is completed. Instead of detecting the sound, the control unit 81 may, for example, communicate with the drug dispensing device 1 to detect that the reverse rotation of the motor 44 has ended.
[0117] In step S44, the control unit 81 vibrates the pump body 10 with the vibration unit 85 for a second time. As mentioned above, the second time is shorter than the first time the drug dispensing device 1 is on standby in step S25 of Figure 12. As mentioned above, the vibration by the vibration unit 85 corresponds to an automated process of flicking the pump body 10 with a finger and has the effect of collecting air bubbles in the reservoir 18 towards the tip.
[0118] In step S45, the control unit 81 determines whether the pump body 10 has been removed from the opening 89 of the desktop cradle 80. The control unit 81 may determine whether the pump body 10 has been removed based, for example, on the detection result of the insertion detection unit 83. If the pump body 10 has been removed (YES in step S45), the control unit 81 proceeds to step S46; otherwise (NO in step S45), it continues the process in step S45 until the pump body 10 is removed.
[0119] In step S46, the control unit 81 turns off the power to the desktop cradle 80. Then, the control unit 81 terminates the flowchart processing.
[0120] As described above, the control unit 71 may start the process of filling the outlet tube 29 with the drug solution after the nut portion 24 has moved toward the base end of the reservoir 18 by a predetermined distance and the operation to remove air bubbles from the reservoir 18 has been performed by the tabletop cradle 80. Therefore, the drug solution dispensing device 1 can automatically detect that the operation to remove air bubbles from the reservoir 18 has been completed and start the process of filling the outlet tube 29 with the drug solution.
[0121] This disclosure is not limited to the embodiments described above. For example, multiple blocks shown in a block diagram may be combined, or one 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. [Explanation of Symbols]
[0122] 1. Drug administration device 10 Pump body 11. Cradle device 12 cartridges 14. Main unit of the device 16 Base section 18 Reservoir 20 plungers 22 Lead screw shaft 24 Nut section 26 deployment ports 28 Derivation Ports 29 Outlet pipe 30 Plunger body 32 Pusher 34 sealing member 36 Extension 38 Nail part 39 Bearings 40 Drive unit 42 Batteries 44 motors 46 Gearbox 48 Output gears 50 Spur gear 52 Transmission shaft 54 terminals 56 Bearings 58 Nut body 60 Slide section 62 screw holes 64 Through holes 66 Reinforcement Cover 68 Guide Wall 70 Lid 71 Control Unit 72 Memory section 73 Communications Department 75 Mounting detection unit 79 Bus 106 connection ports 111 cabinets 121 Top part 123 Front view 124 Back section 126 Side part 137 Guide groove section 138 Engaging hook portion 141 Placement surface section 143 Side wall section 144 Side wall section 151 Guide Rail 152 detection rails 153 Sliding rail 154 Fitting holes 155 Mounting part 156 Posture Correction Department 158 Notches 162 Engagement receiving part 181 Port Unit 182 Cap 80 Desktop Cradle 81 Control Unit 82 Memory section 83 Insertion detection unit 84 Mike 85 Vibration section 90 Remote Control 91 Control Unit 92 Memory section 93 Communications Department 94 Input section 95 Output section 99 Bus 100 Drug administration systems
Claims
1. A drug delivery device that administers a drug solution filled in a reservoir into a living body by the pressing action of a plunger, The reservoir in which the aforementioned chemical solution is filled, A channel connected to the reservoir and for guiding the chemical solution out of the reservoir, The plunger provided within the reservoir and movable in the longitudinal direction of the reservoir, A movable part that, by moving within its range of motion, connects with the plunger and is capable of pressing the plunger toward the tip of the reservoir, A drive unit that moves the movable part within the movable range, Control unit and Equipped with, The control unit, The movable part is connected to the plunger, and when the drug solution is being administered into the body by a pressing action on the plunger, the drive unit is controlled in response to a first operation by the user to move the movable part toward the base end of the reservoir by a predetermined distance. After the movable part has moved toward the base end of the reservoir by the predetermined distance, and an operation to remove air bubbles from the reservoir has been performed, the process of filling the flow path with the chemical solution is initiated. Drug administration device.
2. The drug dispensing device according to claim 1, wherein, when the drug dispensing is interrupted, the control unit moves the movable part toward the base end of the reservoir by a predetermined distance, in response to the first operation of the user, such that the distance the plunger moves to secure a volume in the reservoir greater than the volume in the flow path is predetermined.
3. The drug dispensing device according to claim 1, wherein the control unit moves the movable part toward the base end of the reservoir by a predetermined distance at a first speed in response to the first operation of the user, and then, when an operation to remove air bubbles from the reservoir is performed, moves the movable part toward the tip of the reservoir by a predetermined distance at a first speed, and further moves the movable part toward the tip of the reservoir at a second speed only while the second operation of the user is being performed.
4. The drug dispensing device according to claim 3, wherein the first speed is faster than the second speed.
5. A pump body housing the reservoir, the flow path, the plunger, the movable part, the drive unit, and the control unit, A cradle device having a structure that engages with and can be attached to the pump body, and which can be attached to the patient's skin, A detection unit for detecting whether or not the pump body is mounted on the cradle device, Furthermore, The control unit determines that drug administration has been interrupted when the detection unit detects that the pump body has been removed from the cradle device. A drug solution dispensing device according to any one of claims 1 to 4.
6. The drug dispensing device according to any one of claims 1 to 4, wherein the control unit starts a process to fill the flow path with the drug solution when the user notifies the control unit that an operation to remove air bubbles from the reservoir has been performed after the movable part has moved toward the base end of the reservoir by the predetermined distance.
7. The drug dispensing device according to any one of claims 1 to 4, wherein the control unit starts a process to fill the flow path with the drug solution when the movable part has moved toward the base end of the reservoir by the predetermined distance, and an operation to remove air bubbles from the reservoir has been performed by an external device.
8. A drug solution dispensing device according to any one of claims 1 to 4, A remote control for the user to operate the drug dispensing device, A drug administration system equipped with the following features.
9. A reservoir filled with the medication, A channel connected to the reservoir and for guiding the chemical solution out of the reservoir, A plunger provided within the reservoir and movable in the longitudinal direction of the reservoir, A movable part that, by moving within its range of motion, connects with the plunger and is capable of pressing the plunger toward the tip of the reservoir, A drive unit that moves the movable part within the movable range, Control unit and Equipped with, A method for controlling a drug delivery device that administers the drug solution filled in the reservoir into a living body by the pressing action of the plunger, The control unit, The movable part is connected to the plunger, and when the drug solution is being administered into the body by a pressing action on the plunger, the drive unit is controlled in response to a first operation by the user so that the movable part moves a predetermined distance toward the base end of the reservoir. After the movable part has moved toward the base end of the reservoir by the predetermined distance, and an operation to remove air bubbles from inside the reservoir has been performed, the process of filling the flow path with the chemical solution is to be started. A method for controlling a drug dispensing device, including the method described above.
Citation Information
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