Fluid delivery pump, abnormality detection device, abnormality detection program, and abnormality detection method

Abstract

The present invention is a fluid delivery pump (100) that uses a tube (T1) to deliver a fluid to a living body (AN1). The present invention comprises: a liquid feeding unit (Pm1) that feeds a liquid; at least one clamp (CL1, CL2) that changes the state of the tube to one of an open state and an occluded state; at least one occlusion sensor (BL1, BL2) that detects a value indicating the degree of occlusion of the tube; and a control unit (13) that controls the at least one clamp so as to change the state of the tube. The control unit controls the tube to the occluded state and executes abnormality detection processing for determining whether or not a detection value from the at least one occlusion sensor is abnormal.

Description

Infusion pump, abnormality detection device, abnormality detection program, and abnormality detection method

[0001] The present disclosure relates to an infusion pump, an abnormality detection device, an abnormality detection program, and an abnormality detection method.

[0002] Conventionally, infusion pumps that deliver liquids such as medicines to living organisms at a constant flow rate and are used in hospitals and the like are known. International Publication No. 2018 / 174181 (Patent Document 1) discloses an infusion pump that has a mechanism for pressing a tube from the side to deliver liquid stably to living organisms even when the tube is made of polyvinyl chloride, which has poor resilience. Such infusion pumps may have an occlusion sensor for detecting whether the delivery of the liquid is stagnant.

[0003] International Publication No. 2018 / 174181

[0004] In hospitals and other facilities, an inspection process is periodically performed on infusion pumps equipped with an occlusion sensor to determine whether the occlusion sensor is operating normally. In this inspection process, for example, a medical professional or other person intentionally occludes the tube, causing a delay in the delivery of fluid, and then the occlusion sensor is checked to see if it is operating normally.

[0005] However, in recent years, with the labor shortage becoming a problem, performing inspection procedures such as intentionally blocking the tube manually to delay the delivery of fluid as described above places a burden on medical professionals, etc. The present disclosure has been made in consideration of the above-mentioned problems, and its purpose is to provide an infusion pump that can easily detect an abnormality in the occlusion sensor.

[0006] The present disclosure relates to an infusion pump for delivering a liquid. The infusion pump is an infusion pump that delivers liquid to a living body using a tube. The infusion pump includes a liquid delivery unit that delivers the liquid, at least one clamp that changes the state of the tube to either an open state or a blocked state, at least one occlusion sensor that detects a value indicating the degree of occlusion of the tube, and a control unit that controls the at least one clamp to change the state of the tube. The control unit controls the tube to the blocked state and executes an abnormality detection process to determine whether the detected value of the at least one occlusion sensor is abnormal.

[0007] The present disclosure relates to an abnormality detection device. The abnormality detection device detects an abnormality in an infusion pump that infuses a liquid into a living body using a tube. The infusion pump includes a liquid delivery unit that delivers a liquid, at least one clamp that changes the state of the tube to either an open state or a blocked state, and at least one occlusion sensor that detects a value indicating the degree of occlusion of the tube. The abnormality detection device includes an input / output unit that acquires a detection value of the at least one occlusion sensor, and a control unit that controls the at least one clamp to change the state of the tube. The control unit controls the tube to the blocked state and executes an abnormality detection process that determines whether the detection value of the at least one occlusion sensor is abnormal.

[0008] The present disclosure relates to an abnormality detection program. The abnormality detection program is for detecting an abnormality in an infusion pump that delivers fluid to a living body using a tube. The infusion pump includes a fluid delivery unit that delivers fluid, at least one clamp that can occlude the tube, and at least one occlusion sensor that detects a value indicating the degree of occlusion of the tube. The abnormality detection program causes a computer to execute a step of controlling the tube to the occlusion state and a step of executing an abnormality detection process that determines whether the detection value of the at least one occlusion sensor is abnormal.

[0009] The present disclosure relates to an abnormality detection method for detecting an abnormality in an infusion pump that infuses a liquid into a living body using a tube. The infusion pump includes a liquid delivery unit that delivers a liquid, at least one clamp that can occlude the tube, and at least one occlusion sensor that detects a value indicating the degree of occlusion of the tube. The abnormality detection method includes, as processing executed by a computer, a step of controlling the tube to the occlusion state and a step of executing an abnormality detection process that determines whether the detection value of the at least one occlusion sensor is abnormal.

[0010] According to the present disclosure, in an infusion pump equipped with an occlusion sensor, it is possible to automatically determine whether the occlusion sensor is capable of operating normally.

[0011] Fig. 1 is a diagram for explaining an example of an infusion pump in embodiment 1. Fig. 2 is a block diagram showing the configuration included in the infusion pump. Fig. 3 is a diagram showing the infusion pump as viewed from the positive side of the Y axis when the door part is in an open state. Fig. 4 is a flowchart showing a process for detecting an abnormality in an occlusion sensor. Fig. 5 is a diagram for explaining an example of an infusion pump in embodiment 2.

[0012] Hereinafter, embodiments of the present disclosure will be described with reference to the drawings. In the following description, identical components are designated by the same reference numerals. Their names and functions are also the same. Therefore, detailed descriptions thereof will not be repeated. Furthermore, in the embodiments described below, when numbers, quantities, etc. are mentioned, the scope of the present invention is not necessarily limited to those numbers, quantities, etc., unless otherwise specified.

[0013] [Embodiment 1] <Overall Configuration> Fig. 1 is a diagram illustrating an example of an infusion pump 100 according to embodiment 1. The infusion pump 100 is a pump that delivers a liquid, such as a drug solution or blood, stored in a bottle Bt1 to a living body AN1 at a constant flow rate. A perspective view of the infusion pump 100 is shown in the center of Fig. 1. In this embodiment, the infusion pump 100 has a substantially rectangular parallelepiped shape.

[0014] The infusion pump 100 has a door 80 and a housing 52. As will be described later, the door 80 is configured to be openable and closable from the housing 52, and Fig. 1 shows the infusion pump 100 in a closed state with the door 80 in the closed state. The front surface Sf1 of the door 80 is provided with switches Sw1 to Sw3 for receiving commands from the user and a display Di1 for displaying information to the user.

[0015] In the following description, the direction along the long side of the front surface Sf1 is referred to as the “Z-axis direction,” the direction perpendicular to the Z-axis direction and along the short side of the front surface Sf1 is referred to as the “X-axis direction,” and the direction perpendicular to both the Z-axis direction and the X-axis direction is referred to as the “Y-axis direction.” In the following description, the positive direction of the Z-axis in each drawing may be referred to as the upper side, and the negative direction may be referred to as the lower side.

[0016] As shown in Figure 1, the infusion pump 100 delivers liquid stored in a bottle Bt1 to a living body AN1 via a tube T1. The tube T1 is hollow. The liquid in the bottle Bt1 passes through the hollow portion of the tube T1 and is delivered to the living body AN1 via the infusion pump 100. In other words, the tube T1 constitutes an infusion line L from the bottle Bt1 to the living body AN1. The tube T1 is made of soft polyvinyl chloride resin or polybutadiene resin, which has excellent resistance to chemical solutions.

[0017] In the infusion line L, the infusion pump 100 is disposed between the bottle Bt1 and the living body AN1. Hereinafter, the direction in the infusion line L when looking at the bottle Bt1 from the infusion pump 100 will be referred to as the "upstream direction." Also, in the infusion line L, the direction in the infusion line L when looking at the living body AN1 from the infusion pump 100 will be referred to as the "downstream direction."

[0018] The switch Sw1 is a switch for starting the infusion pump 100. The switch Sw2 is a switch for stopping the infusion pump 100. The switch Sw3 is a switch for adjusting the flow rate of the infusion pump 100.

[0019] 2 is a block diagram showing the components included in the infusion pump 100. The infusion pump 100 according to this embodiment includes various components 110 and an abnormality detection device 10. The various components 110 include a clamp CL1, a clamp CL2, an occlusion sensor BL1, an occlusion sensor BL2, a liquid supply pump PM1, a door sensor DS1, a start switch Sw1, and a stop switch Sw2.

[0020] Clamps CL1 and CL2 are devices that block the tube T1, physically blocking the flow of fluid. Clamps CL1 and CL2 block the flow of fluid, for example, by physically clamping the tube T1. Note that the method by which clamps CL1 and CL2 block the tube T1 is not limited to clamping, and other methods of blocking the tube T1 may also be used. Hereinafter, clamps CL1 and CL2 may be collectively referred to simply as "clamps CL." Clamp CL1 may correspond to the "first clamp" in this disclosure, and clamp CL2 may correspond to the "second clamp" in this disclosure.

[0021] The occlusion sensors BL1 and BL2 are sensors for determining whether the flow of liquid passing through the tube T1 is stagnant. For example, the occlusion sensors BL1 and BL2 acquire the pressure value inside the tube T1. As an example, the occlusion sensors BL1 and BL2 are sensors that acquire the pressure value inside the tube T1 using a Hall element.

[0022] As the degree of blockage of the tube T1 increases, the pressure value inside the tube T1 increases. When the acquired pressure value inside the tube T1 exceeds a predetermined threshold, the blockage sensors BL1 and BL2 determine that the flow of liquid passing through the tube T1 is stagnating. In this way, the blockage sensors BL1 and BL2 acquire the pressure value inside the tube T1 as a value indicating the degree of blockage of the tube T1.

[0023] Hereinafter, the occlusion sensor BL1 and the occlusion sensor BL2 may be collectively referred to simply as the “occlusion sensor BL.” The occlusion sensor BL1 may correspond to the “first occlusion sensor” in this disclosure, and the occlusion sensor BL2 may correspond to the “second occlusion sensor” in this disclosure.

[0024] The liquid feed pump PM1 is a pump for delivering the liquid in the bottle Bt1 to the living organism AN1 at a constant flow rate. In this embodiment, the liquid feed pump PM1 includes fingers (described later) and delivers the liquid in the bottle Bt1 to the living organism AN1 by pressing the tube T1 from the outside of the tube T1 from the upstream to downstream direction relative to the tube T1. Note that the liquid feed pump PM1 does not have to be a pump with fingers, and may be a pump of another type.

[0025] The door sensor DS1 is a sensor for detecting the open or closed state of the door 80. The start switch Sw1 is a switch for starting the operation of the infusion pump PM1 and starting the infusion of the infusion pump 100. When the start switch Sw1 is pressed, the state of the infusion pump 100 transitions to the "drive mode."

[0026] The stop switch Sw2 is a switch for stopping the operation of the infusion pump PM1 and stopping the infusion of the infusion pump 100. When the stop switch Sw2 is pressed, the state of the infusion pump 100 transitions to the "stop mode."

[0027] When the start switch Sw1 and the stop switch Sw2 are operated by the user, the state of the infusion pump 100 transitions between the "drive mode" and the "stop mode." The start switch Sw1 and the stop switch Sw2 may be physical switches or software switches configured on a touch panel.

[0028] The abnormality detection device 10 determines whether the occlusion sensor BL is operating normally. The abnormality detection device 10 includes an interface 11, a memory 12, a control unit 13, a storage device 14, and an alarm unit 15. The abnormality detection device 10 may be a general-purpose computer or a computer dedicated to determining whether the occlusion sensor BL is operating normally.

[0029] The control unit 13 is a computing entity (computer) that executes various processes by executing various programs. The control unit 13 is configured with a processor such as a CPU (central processing unit) or an MPU (micro-processing unit). Note that a processor, which is an example of the control unit 13, has the function of executing various processes by executing programs, but some or all of these functions may be implemented using dedicated hardware circuits such as an ASIC (application specific integrated circuit) or an FPGA (field-programmable gate array).

[0030] The term "processor" is not limited to a processor in the narrow sense that executes processing using a stored program, such as a CPU or MPU, but may also include hardwired circuits such as an ASIC or FPGA. Therefore, the "processor" that is an example of the control unit 13 can also be interpreted as a processing circuitry in which processing is defined in advance by computer-readable code and / or hardwired circuits.

[0031] The control unit 13 may be configured as a single chip or multiple chips. Furthermore, the processor and related processing circuits may be configured as multiple computers interconnected by wire or wirelessly via a local area network or a wireless network. The processor and related processing circuits may be configured as a cloud computer that performs calculations remotely based on input data and outputs the calculation results to another device in a remote location.

[0032] The memory 12 includes a volatile storage area (e.g., a working area) that temporarily stores program code, work memory, and the like when the control unit 13 executes various programs. Examples of the memory 12 include volatile memory such as dynamic random access memory (DRAM) and static random access memory (SRAM), or read-only memory (ROM). Note that the memory 12 may also be a non-volatile memory.

[0033] The storage device 14 stores various programs and various data executed by the control unit 13. The storage device 14 may be one or more non-transitory computer-readable media, or one or more computer-readable storage media. An example of the storage device 14 is a flash memory. The storage device 14 may also be a hard disk drive (HDD), a solid state drive (SSD), or the like.

[0034] The storage device 14 according to the first embodiment stores an abnormality detection program 145 and tube base material data 141. The abnormality detection program 145 is a program for executing a process for detecting an abnormality in the blockage sensor BL. The tube base material data 141 includes, for each base material of the tube T1, a pressure value inside the tube T1 when the tube T1 is in a blocked state. The tube base material data 141 may correspond to a "determination value" in the present disclosure.

[0035] The tube T1 is required to be resistant to chemicals. Therefore, as described above, the base material of the tube T1 may be, for example, soft vinyl chloride resin or polybutadiene resin. Soft vinyl chloride resin and polybutadiene resin have different moduli of elasticity. Therefore, the degree of expansion change of the tube T1 when the tube T1 is in a closed state also differs.

[0036] The tube base material data 141 includes, for example, data indicating that when the soft vinyl chloride resin tube T1 becomes clogged, the internal pressure of the soft vinyl chloride resin tube T1 falls within a predetermined range. The tube base material data 141 also includes, for example, data indicating that when the polybutadiene resin tube T1 becomes clogged, the internal pressure of the polybutadiene resin tube T1 falls within a predetermined range. The tube base material data 141 is determined in advance through experiments, simulations, etc.

[0037] The interface 11 transmits and receives data to and from the various components 110 via wired or wireless communication. For example, the detection value of the occlusion sensor BL is input to the interface 11. The interface 11 also outputs a command to the liquid feed pump PM1 to drive the liquid feed pump PM1. The abnormality detection device 10 is not limited to one interface 11, and may include multiple interfaces 11 depending on the number of communication targets.

[0038] The notification unit 15 notifies the user that an abnormality has occurred. For example, the notification unit 15 plays a sound indicating the occurrence of the abnormality from a speaker. The notification unit 15 may also display an indication of the occurrence of the abnormality on the display Di1. Furthermore, the notification unit 15 may transmit information indicating the occurrence of the abnormality to an information terminal such as a smartphone owned by the user or a display device located in a nurse's waiting room. In the example of FIG. 2 , the abnormality detection device 10 is included in the infusion pump 100, but the abnormality detection device 10 may also be provided separately from the infusion pump 100.

[0039] 3 is a view of the infusion pump 100 viewed from the positive side of the Y axis when the door 80 is in an open state. The infusion pump 100 is shown in FIG. 3 with the door 80 in an open state and the housing 52. The housing 52 and the door 80 are connected by a hinge 81.

[0040] Figure 3 shows the back surface Sf2 of the door unit 80. The back surface Sf2 and the front surface Sf1 are back to back. Figure 3 shows the front surface Sf3 of the housing. The door unit 80 opens and closes around a point where it is fixed by a hinge 81. When the door unit 80 is in the open state, both the back surface Sf2 and the front surface Sf1 are exposed on the positive side of the Y axis. When the door unit 80 is in the closed state, the back surface Sf2 and the front surface Sf1 face each other.

[0041] The front surface Sf3 is formed with a tube mounting portion 57 for vertically storing a tube constituting the infusion line L. The tube mounting portion 57 is, for example, a groove capable of fixing the tube.

[0042] A liquid feed pump PM1 configured to be detachable with four screws Sp1 is provided near the center of the tube attachment part 57. The liquid feed pump PM1 has finger parts 91. The finger parts 91 can be injection molded from a resin that has excellent chemical resistance.

[0043] A hook 56 is formed on the positive side of the X-axis of the housing 52. A door lever 84 formed on the back surface Sf2 of the door 80 is engaged with the hook 56, thereby maintaining the door 80 in a closed state. The infusion pump 100 is provided with a sensor (door sensor DS1 in FIG. 2) not shown in FIG. 3 that detects whether the door 80 is open or closed. The door sensor DS1 detects whether the door lever 84 is engaged with the hook 56.

[0044] An occlusion sensor BL1 is disposed upstream of the infusion pump PM1 in the infusion line L. A tube pressing member BT1 is disposed on the back surface Sf2 in a position facing the occlusion sensor BL1 when the door 80 is in the closed state. Similarly, an occlusion sensor BL2 is disposed downstream of the infusion pump PM1 in the infusion line L. A tube pressing member BT2 is disposed on the back surface Sf2 in a position facing the occlusion sensor BL2 when the door 80 is in the closed state.

[0045] The occlusion sensor BL having a Hall element may include a permanent magnet and a pickup for analog detection of the movement position of the permanent magnet. The occlusion sensor BL detects the position of the permanent magnet as it moves in response to changes in the expansion of the tube T1 due to the occlusion of the tube T1. As a result, the occlusion sensor BL detects the pressure inside the tube T1 in response to changes in the expansion of the tube T1.

[0046] Clamp CL1 is disposed upstream of occlusion sensor BL1. That is, occlusion sensor BL1 detects the pressure inside tube T1 between liquid feed pump PM1 and clamp CL1. Clamp CL2 is disposed downstream of occlusion sensor BL2. Occlusion sensor BL2 detects the pressure inside tube T1 between liquid feed pump PM1 and clamp CL2.

[0047] The clamps CL1 and CL2 are mechanisms that press the tube T1 from the outside to stop the flow of the medicinal liquid in the tube T1. The state in which the clamps CL stop the flow of the medicinal liquid in the tube T1 is called the "closed state." The state in which the clamps CL do not stop the flow of the medicinal liquid in the tube T1 is called the "open state."

[0048] The operating principle of the liquid feed pump PM1 will be described. The liquid feed pump PM1 has a finger unit 91. The finger unit 91 includes multiple finger members. When the liquid feed pump PM1 is operating, the multiple finger members are configured to sequentially reciprocate in the Y-axis direction, starting from the upstream side (the positive side of the Z-axis). Liquid in the tube T1 attached to the liquid feed pump PM1 is sent to the living body AN1 by being pressed by the finger unit 91 sequentially from the upstream side. The speed of the reciprocating movement of the finger unit 91 can be set by the user via switch Sw3.

[0049] The infusion pump 100 of this embodiment also includes an air bubble sensor 54 upstream of the occlusion sensor BL1. The air bubble sensor 54 is a sensor that stops the operation of the infusion pump 100 when it detects air bubbles in the tubing constituting the infusion line L, the amount of which exceeds a predetermined amount (approximately 0.08 cc) that corresponds to a predetermined length (e.g., approximately 10 mm) within the tubing. When the door 80, which faces the air bubble sensor 54, is closed, the tubing T1 is immobilized, enabling accurate air bubble detection.

[0050] <Flowchart> Fig. 4 is a flowchart showing a process for detecting an abnormality in the blockage sensor BL. The flowchart shown in Fig. 4 is realized by the control unit 13 executing the abnormality detection program 145.

[0051] The control unit 13 determines whether the door unit 80 is in a closed state (step S101). If the door unit 80 is in an open state (NO in step S101), the control unit 13 ends the process. If the door unit 80 is in a closed state (YES in step S101), the control unit 13 determines whether the start switch Sw1 has been pressed (step S102). If the start switch Sw1 has not been pressed (NO in step S102), the process ends.

[0052] When the start switch Sw1 is pressed (YES in step S102), the control unit 13 controls the state of the clamp CL to the closed state (step S103). That is, the state of the clamp CL1 and the state of the clamp CL2 become the closed state. Based on the pressing of the start switch Sw1, the control unit 13 controls the state of the infusion pump 100 to the "drive mode."

[0053] The control unit 13 starts driving the liquid feed pump PM1 (step S104). The control unit 13 acquires the detection values ​​of the occlusion sensors BL1 and BL2 (step S105). That is, the control unit 13 acquires the detection values ​​of the occlusion sensors BL1 and BL2.

[0054] The control unit 13 determines whether the detection value of the occlusion sensor BL is an abnormal value (step S106). The processes of steps S103 to S106 may correspond to the "abnormality detection process" in this disclosure. If the detection value of the occlusion sensor BL is not within a predetermined range based on the pressure value of the tube T1 in the occluded state, which is included in the tube base material data 141, the control unit 13 detects that an abnormality has occurred in the occlusion sensor BL.

[0055] If the detection value of the occlusion sensor BL is an abnormal value (YES in step S106), the control unit 13 stops driving the liquid supply pump PM1 (step S107). The control unit 13 controls the state of the clamp CL to an open state (step S108). The control unit 13 notifies the user that an abnormality has occurred in the occlusion sensor BL (step S109), and ends the process.

[0056] If the detected value of the occlusion sensor BL is not an abnormal value (NO in step S106), the control unit 13 determines whether the infusion pump 100 is in a stop mode (step S110). If the infusion pump 100 is not in the stop mode (NO in step S110), the control unit 13 determines the type of the tube T1 and determines the threshold value of the occlusion sensor BL based on the determined type of the tube T1 (step S111).

[0057] As described above, the base material of the tube T1 may be soft polyvinyl chloride resin or polybutadiene resin, which have different elastic moduli and therefore different degrees of expansion change. Therefore, the detection value of the occlusion sensor BL1 when the tube T1 is in an occluded state will differ. In the infusion pump 100 of this embodiment, the base material of the tube T1 is determined using the detection value of the occlusion sensor BL1 acquired in step S105. Specifically, the control unit 13 determines the base material of the attached tube T1 based on the detection value of the occlusion sensor BL1 acquired in step S105 by referring to the tube base material data 141. Furthermore, the control unit 13 determines the threshold value of the detection value of the occlusion sensor BL for determining that the tube T1 is occluded in the drive mode based on the determined base material of the tube T1. This allows the infusion pump 100 to more accurately detect whether the tube T1 is occluded in the drive mode.

[0058] Next, the control unit 13 drives the liquid supply pump PM1 in a reverse flow manner to send the infusion liquid from downstream to upstream (step S112). After a predetermined period of time has elapsed, the control unit 13 stops driving the liquid supply pump PM1 in a reverse flow manner (step S113). As a result, the liquid sent for the abnormality detection process in the tube T1 is pushed back upstream. The control unit 13 controls the state of the clamp CL to an open state (step S114).

[0059] The control unit 13 determines whether the infusion pump 100 is in the drive mode (step S115). If the infusion pump 100 is in the drive mode (YES in step S115), the control unit 13 starts driving the infusion pump 115 (step S116). In step S116, the control unit 13 causes the infusion pump 115 to deliver the infusion at a predetermined flow rate based on a command input by the user via switch Sw3 or the like.

[0060] The control unit 13 determines whether the stop switch Sw2 has been pressed (step S117). If the stop switch Sw2 has not been pressed (NO in step S117), the control unit 13 repeats the process of step S116. That is, the liquid feed pump PM1 continues to be driven.

[0061] If the stop switch Sw2 is pressed (YES in step S117), the control unit 13 stops driving the infusion pump PM1 (step S118). Based on the fact that the stop switch Sw2 is pressed, the control unit 13 controls the infusion pump 100 to a stop mode. The control unit 13 executes the abnormality detection process of steps S103 to S106.

[0062] If the detection value of the occlusion sensor BL is not an abnormal value (NO in step S106), the control unit 13 determines whether the system is in the stop mode (step S110). If the system is in the stop mode (YES in step S110), the control unit 13 drives the liquid supply pump PM1 to reverse flow for a predetermined period of time without determining the type of tube T1 (step S112). Thereafter, the control unit 13 stops the liquid supply pump PM1 (S113) and controls the clamp CL to an open state (step S114). After the abnormality detection process following the depression of the stop switch Sw2, the control unit 13 is not in the drive mode (NO in step S115), and therefore ends the process.

[0063] In this manner, the infusion pump 100 of this embodiment can automatically determine whether the occlusion sensor BL is operating normally when the infusion pump PM1 starts and stops, and can notify the operator if an abnormality occurs. This reduces the workload for performing inspection procedures in the infusion pump 100 of this embodiment.

[0064] Furthermore, in this embodiment, the abnormality detection process may also detect an abnormality in the air bubble sensor 54 in addition to the blockage sensor BL. The air bubble sensor 54 operates when the door unit 80 is in the closed state, and therefore the abnormality detection process for the air bubble sensor 54 can be executed only when the door unit 80 is in the closed state. In this embodiment, the abnormality detection process for the blockage sensor BL is executed when the door unit 80 is in the closed state, and therefore the abnormality detection process for the blockage sensor BL and the abnormality detection process for the air bubble sensor 54 can be executed simultaneously.

[0065] [Embodiment 2] In embodiment 1, the configuration of the infusion pump 100 that delivers the liquid in the bottle Bt1 has been described. In embodiment 2, the configuration of the infusion pump that delivers the liquid in a syringe will be described.

[0066] Fig. 5 is a diagram illustrating an example of an infusion pump 100A according to embodiment 2. Note that in Fig. 5, description of the configuration that overlaps with that of infusion pump 100 in Fig. 1 will not be repeated.

[0067] 5, the infusion pump 100A is a syringe pump that is used with a syringe Sr1. The syringe Sr1 includes a barrel 20 and a plunger rod 30.

[0068] The barrel 20 has a substantially cylindrical outer shape. A liquid inlet 22 is provided at the tip of the barrel 20. A first flange 21 is provided at the rear end of the barrel 20. The barrel 20 is made of a transparent or translucent resin such as polypropylene. A lubricating oil such as silicone oil may be applied to the inner peripheral surface of the barrel 20. The inside of the barrel 20 is filled with a medicinal liquid.

[0069] The plunger rod 30 is fitted inside the barrel 20 and has a second flange 31 at its rear end. A gasket portion 32 that comes into sliding contact with the inner circumferential surface of the barrel 20 is provided at the tip end of the plunger rod 30. The gasket portion 32 is made of an elastic material such as vulcanized rubber or thermoplastic elastomer. The rest of the plunger rod 30 other than the gasket portion 32 is made of a resin such as polypropylene.

[0070] As shown in FIG. 5, the infusion pump 100A includes a barrel receiving portion 119, a groove portion 111, a fluid delivery portion 120, and an operation panel 180.

[0071] The barrel 20 is placed on the barrel receiving portion 119. The barrel receiving portion 119 has a concave portion that contacts the lower portion of the outer circumferential surface of the barrel 20. The groove portion 111 is provided at the rear end of the barrel receiving portion 119. The first flange 21 is inserted into the groove portion 111. The barrel receiving portion 119 and the groove portion 111 are formed by integral molding.

[0072] The liquid delivery unit 120 has a pressing surface 121 that presses the second flange 31, and a movable claw 122 that holds the second flange 31 by clamping it against the pressing surface 121. The movable claw 122 is biased in a direction approaching the pressing surface 121 by a biasing mechanism such as a spring. The liquid delivery unit 120 holds the plunger rod 30 so that it can move toward the barrel 20. When the liquid delivery unit 120 moves the plunger rod 30 toward the barrel 20, the medicinal liquid in the barrel 20 is injected into the tube T1 through the liquid inlet 22.

[0073] The liquid delivery unit 120 further has a clutch lever 123 for manually adjusting the position of the liquid delivery unit 120 itself and the position of the movable claw 122 in the extension direction of the plunger rod 30 when attaching or detaching the plunger rod 30. Specifically, by rotating the clutch lever 123 in one direction, the liquid delivery unit 120 enters a locked state in which manual movement of the liquid delivery unit 120 is restricted, and the movable claw 122 is maintained in a state in which it is biased toward the pressing surface 121. By rotating the clutch lever 123 in the other direction, the liquid delivery unit 120 enters an unlocked state, and the movable claw 122 is moved away from the pressing surface 121 against the biasing force.

[0074] The configuration of the liquid delivery section 120 is not limited to the above, and the liquid delivery section 120 may have a pressing surface 121 that presses the second flange 31, and a fixed claw portion that accommodates the second flange 31 between the pressing surface 121.

[0075] The operation panel 180 includes a display that displays the status of the infusion pump 100A, and operation buttons that are operated by a user (e.g., a medical professional).

[0076] 5, the tube T1 is provided with a clamp CL. The clamp CL may be configured to close the tube T1 by applying pressure from the outside, as in the first embodiment, or may have another configuration.

[0077] The infusion pump 100A further includes a pressure sensor 140. The pressure sensor 140 is provided on the pressing surface 121 and is a sensor that measures the pressure applied to the barrel 20 when the medicinal solution is delivered from the barrel 20. The pressure applied to the barrel 20 is detected on the pressing surface 121 as a pressure applied by the member of the second flange 31.

[0078] The abnormality detection device 10 detects an abnormality related to the occlusion state of the tube T1, for example, based on the pressure measured by the pressure sensor 140. The pressure sensor 140 in the second embodiment is an example of an "occlusion sensor" in the present disclosure. The infusion pump 100A may detect an abnormality of the infusion pump 100 based on two parameters: the pressure applied to the barrel 20 measured by the pressure sensor 140, and the amount of change in the pressure per unit time. This allows the infusion pump 100A to reduce the time required to detect an abnormality compared to when detecting an abnormality based only on the pressure applied to the barrel 20.

[0079] In the example of the second embodiment, in order to prevent the abnormality detection process related to the blockage of the tube T1 from being executed using the detection value of the pressure sensor 140 when the tube T1 is not set, the device has a tube sensor Rs1 that determines whether the tube T1 is set. The tube sensor Rs1 may be, for example, an infrared sensor. In this way, in the example of the second embodiment, it is possible to prevent the abnormality detection process from being executed even when the tube T1 is not set.

[0080] In embodiment 2, if the control unit 13 detects that the tube T1 is set by the tube sensor Rs1 before executing the abnormality detection process (steps S103 to S106), it executes abnormality detection process regarding blockage of the tube T1 using the detection value of the pressure sensor 140.

[0081] The types of syringes that can be attached to the infusion pump 100A include disposable syringes and prefilled syringes. Just before using a disposable syringe, a user fills the barrel 20 of the disposable syringe with a medicinal solution. On the other hand, a prefilled syringe is a syringe in which the barrel 20 is prefilled with a medicinal solution.

[0082] The prefilled syringe is configured to be able to be stored for a long period of time (for example, two years) while filled with a drug. The prefilled syringe is configured to be highly airtight so that it can withstand long-term storage. Therefore, in the prefilled syringe, the frictional resistance of the gasket portion when pushing out the drug solution is higher than the frictional resistance of a disposable syringe. If the frictional resistance of the syringe is high, the detection value of the pressure sensor 140 will be high.

[0083] In the second embodiment, the detection values ​​of the pressure sensors 140 of the prefilled syringe and the disposable syringe when the clamp CL is in the closed state are stored in the storage device 14. The control unit 13 in the second embodiment can automatically determine whether the syringe set is a prefilled syringe or a disposable syringe, using the detection values ​​of the pressure sensors 140 when the clamp CL is in the closed state. The control unit 13 in the second embodiment performs an abnormality detection process related to the blockage of the tube T1 and controls the pressure sensor 140, depending on the automatically determined type of syringe.

[0084] In the above example, the blockage sensor BL includes a Hall element. However, the blockage sensor BL may be a sensor that does not include a Hall element and uses a strain gauge to detect the expansion change of the tube T1 to detect the blockage state of the tube T1. In this case, the blockage sensor BL detects the amount of strain caused by deformation of a steel plate or the like in response to the expansion change of the tube T1 to detect the blockage state of the tube T1, and may be provided on the back surface Sf2 of the door section 80.

[0085] In the first embodiment described above, the clamps CL1 and CL2 and the occlusion sensors BL1 and BL2 are disposed on both the upstream and downstream sides of the infusion pump PM1. In some aspects, the infusion pump 100 may include the clamps CL1 and CL2 on only one of the upstream and downstream sides of the infusion pump PM1.

[0086] In the first embodiment described above, the abnormality detection process is executed based on pressing of the start switch Sw1. In some cases, the infusion pump 100 may execute the abnormality detection process based on the door 80 being in the closed state. That is, the process of step S102 in FIG. 4 may be omitted. This allows the infusion pump 100 to quickly execute the abnormality detection process based on the door 80 being in the closed state after the door 80 is in the open state and the tube T1 is attached by the user, regardless of whether the start switch Sw1 is pressed.

[0087] In the above-described first embodiment, a configuration without the tube sensor Rs1 has been described. However, the infusion pump 100 in the first embodiment may also include the tube sensor Rs1. Also, in the above example, the pressure sensor 140 is used as an example of an occlusion sensor in the second embodiment. However, the infusion pump 100A in the second embodiment may also use an occlusion sensor BL having a Hall element, as in the first embodiment.

[0088] <Aspects> (Configuration 1) The infusion pump of the present disclosure is an infusion pump that infuses a liquid into a living body using a tube. The infusion pump includes a liquid delivery unit that delivers a liquid, at least one clamp that changes the state of the tube to either an open state or a blocked state, at least one occlusion sensor that detects a value indicating the degree of occlusion of the tube, and a control unit that controls the at least one clamp to change the state of the tube. The control unit controls the tube to the blocked state and executes an abnormality detection process that determines whether the detected value of the at least one occlusion sensor is abnormal.

[0089] (Configuration 2) In the infusion pump of Configuration 1, the control unit acquires the detection value of at least one occlusion sensor when the tube is in an occluded state and liquid is being delivered by the delivery unit, and performs an abnormality detection process based on the acquired detection value and at least one judgment value.

[0090] (Configuration 3) In the infusion pump of configuration 2, the control unit notifies the occurrence of an abnormality when the abnormality detection process determines that the detected value is abnormal.

[0091] (Configuration 4) In the infusion pump of Configuration 2, at least one judgment value includes a judgment value according to the type of tube, and the control unit identifies the type of tube based on the detection value, and determines a threshold value for detecting whether at least one occlusion sensor is in an occluded state based on the judgment value according to the identified type of tube.

[0092] (Configuration 5) The infusion pump of Configuration 1 or Configuration 2 further includes a stop switch that stops the delivery of the liquid by the delivery unit. The control unit executes an abnormality detection process based on the delivery of the liquid being stopped by the stop switch.

[0093] (Configuration 6) The infusion pump of any one of Configurations 1 to 5 further includes a start switch that starts the delivery of the liquid from the delivery unit. The control unit executes an abnormality detection process based on the start of the delivery of the liquid by the start switch.

[0094] (Configuration 7) The infusion pump of any one of Configurations 1 to 5 further includes a door for exposing the infusion unit to the outside or for storing the infusion unit within the housing, and a door sensor for detecting the open / closed state of the door. When the door sensor detects that the state of the door has transitioned from an open state to a closed state, the control unit executes an abnormality detection process.

[0095] (Configuration 8) The infusion pump of configuration 7 further includes an air bubble sensor that is operable when the door is in the closed state.

[0096] (Configuration 9) In the infusion pump of any of Configurations 1 to 8, the at least one clamp includes a first clamp and a second clamp, the at least one occlusion sensor includes a first occlusion sensor and a second occlusion sensor, the first occlusion sensor is disposed between the first clamp and the fluid delivery section in a path along the tube, and the second occlusion sensor is disposed between the second clamp and the fluid delivery section in a path along the tube.

[0097] (Configuration 10) In the infusion pump of any one of configurations 1 to 9, the liquid delivery section has a plurality of fingers that sequentially press the tube to deliver the liquid in the tube.

[0098] (Configuration 11) In the infusion pump of any one of Configurations 1 to 6, the liquid delivery section presses the syringe to deliver the liquid in the syringe.

[0099] (Configuration 12) The abnormality detection device disclosed herein is an abnormality detection device that detects an abnormality in an infusion pump that infuses a liquid into a living organism using a tube. The infusion pump includes a liquid delivery unit that delivers the liquid, at least one clamp that changes the state of the tube to either an open state or a blocked state, and at least one occlusion sensor that detects a value indicating the degree of occlusion of the tube. The abnormality detection device includes an input / output unit that acquires a detection value of the at least one occlusion sensor, and a control unit that controls the at least one clamp to change the state of the tube. The control unit controls the tube to the blocked state and executes an abnormality detection process that determines whether the detection value of the at least one occlusion sensor is abnormal.

[0100] (Configuration 13) The present disclosure provides an anomaly detection program for detecting an anomaly in an infusion pump that delivers fluid to a living organism using a tube. The infusion pump includes a fluid delivery unit that delivers fluid, at least one clamp that changes the state of the tube to either an open state or a blocked state, and at least one occlusion sensor that detects a value indicating the degree of occlusion of the tube. The anomaly detection program causes a computer to control the tube to the blocked state and to execute an anomaly detection process that determines whether the detected value of the at least one occlusion sensor is abnormal.

[0101] (Configuration 14) An anomaly detection method of the present disclosure is an anomaly detection method for detecting an anomaly in an infusion pump that delivers an infusion to a living body using a tube. The infusion pump includes a fluid delivery unit that delivers a liquid, at least one clamp that changes the state of the tube to either an open state or a blocked state, and at least one occlusion sensor that detects a value indicating the degree of occlusion of the tube. The anomaly detection method includes, as processing executed by a computer, a step of controlling the tube to the blocked state and a step of executing an anomaly detection process that determines whether the detected value of the at least one occlusion sensor is abnormal.

[0102] The embodiments disclosed herein should be considered to be illustrative in all respects and not restrictive. The scope of the present disclosure is defined by the scope of the claims, and it is intended to include all modifications within the meaning and scope of the claims.

[0103] 10 Abnormality detection device, 11 Interface, 12 Memory, 13 Control unit, 14 Storage device, 15 Notification unit, 20 Barrel, 21 First flange, 22 Inlet, 30 Plunger rod, 31 Second flange, 32 Gasket unit, 52 Housing, 54 Air bubble sensor, 56 Hook, 57 Tube mounting unit, 80 Door unit, 81 Hinge, 84 Door lever, 91 Finger unit, 100, 100A Infusion pump, 110 Various components, 111 Groove, 115, PM1 Infusion pump, 119 Barrel receiving unit, 120 Infusion unit, 121 Pressing surface, 122 Movable claw unit, 123 Clutch lever, 140 Abnormality detection program, 141 Tube substrate data, 180 Operation panel, AN1 Living body, BL, BL1, BL2 Occlusion sensor, BT1, BT2 tube clamp, Bt1 bottle, CL, CL1, CL2 clamp, DS1 door sensor, Di1 display, L infusion line, Rs1 tube sensor, Sf1, Sf3 front, Sf2 back, Sp1 screw, Sr1 syringe, Sw1 start switch, Sw2 stop switch, T1 tube.

Claims

1. An infusion pump for infusing fluid into a living organism using a tube, comprising: a fluid delivery unit for delivering the fluid; at least one clamp for changing the state of the tube to either an open state or a blocked state; at least one occlusion sensor for detecting a value indicating the degree of occlusion of the tube; and a control unit for controlling the at least one clamp to change the state of the tube, wherein the control unit controls the tube to the blocked state and performs an abnormality detection process for determining whether the detection value of the at least one occlusion sensor is abnormal.

2. The infusion pump of claim 1, wherein the control unit acquires the detection value of the at least one occlusion sensor when the tube is in the occluded state and the liquid is being delivered by the liquid delivery unit, and executes the abnormality detection process based on the acquired detection value and at least one judgment value.

3. An infusion pump as described in claim 1 or claim 2, wherein the control unit notifies the occurrence of an abnormality when the abnormality detection process determines that the detected value is abnormal.

4. The infusion pump of claim 2, wherein the at least one judgment value includes a judgment value according to the type of the tube, and the control unit identifies the type of the tube based on the detection value, and determines a threshold value for detecting whether the at least one occlusion sensor is in the occluded state based on the judgment value according to the identified type of tube.

5. An infusion pump as described in claim 1 or claim 2, further comprising a stop switch that stops the delivery of the liquid by the liquid delivery unit, and the control unit executes the abnormality detection process based on the delivery of the liquid being stopped by the stop switch.

6. An infusion pump as described in claim 1 or claim 2, further comprising a start switch that starts the delivery of the liquid from the liquid delivery section, and the control section executes the abnormality detection process based on the delivery of the liquid being started by the start switch.

7. An infusion pump as described in claim 1 or claim 2, further comprising a door section for exposing the fluid delivery section to the outside or storing the fluid delivery section within the housing, and a door opening / closing sensor for detecting the open / closed state of the door section, wherein the control section executes the abnormality detection process when the door opening / closing sensor detects that the state of the door section has transitioned from an open state to a closed state.

8. The infusion pump according to claim 7, further comprising an air bubble sensor operable when the door is in a closed state.

9. An infusion pump as described in claim 1 or claim 2, wherein the at least one clamp includes a first clamp and a second clamp, the at least one occlusion sensor includes a first occlusion sensor and a second occlusion sensor, the first occlusion sensor is positioned between the first clamp and the fluid delivery section in a path along the tube, and the second occlusion sensor is positioned between the second clamp and the fluid delivery section in a path along the tube.

10. An infusion pump as described in claim 1 or claim 2, wherein the liquid delivery section has a plurality of fingers that sequentially press against the tube to deliver the liquid in the tube.

11. The infusion pump according to claim 1 or 2, wherein the liquid delivery section presses the syringe to deliver the liquid in the syringe.

12. An abnormality detection device that detects abnormalities in an infusion pump that infuses fluid into a living organism using a tube, wherein the infusion pump comprises: a fluid delivery unit that delivers fluid; at least one clamp that changes the state of the tube to either an open state or a blocked state; and at least one occlusion sensor that detects a value indicating the degree of blockage of the tube; and the abnormality detection device comprises: an input / output unit that acquires the detection value of the at least one occlusion sensor; and a control unit that controls the at least one clamp to change the state of the tube, and the control unit controls the tube to the blocked state and executes an abnormality detection process to determine whether the detection value of the at least one occlusion sensor is abnormal.

13. An abnormality detection program for detecting an abnormality in an infusion pump that infuses fluid into a living organism using a tube, wherein the infusion pump comprises: a fluid delivery unit that delivers fluid; at least one clamp that changes the state of the tube to either an open state or a blocked state; and at least one occlusion sensor that detects a value indicating the degree of occlusion of the tube, the abnormality detection program causing a computer to execute the steps of controlling the tube to the blocked state; and executing an abnormality detection process that determines whether the detection value of the at least one occlusion sensor is abnormal.

14. An abnormality detection method for detecting an abnormality in an infusion pump that infuses fluid into a living organism using a tube, wherein the infusion pump comprises: a fluid delivery unit that delivers fluid; at least one clamp that changes the state of the tube to either an open state or a blocked state; and at least one occlusion sensor that detects a value indicating the degree of blockage of the tube, and the abnormality detection method includes, as processing executed by a computer, a step of controlling the tube to the blocked state; and a step of executing an abnormality detection process that determines whether the detection value of the at least one occlusion sensor is abnormal.

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