System for performing continuous infusion procedure using at least two infusion devices

By designing a system including an adjustable infusion device and a control system, the dose fluctuation caused by mismatch in flow rate between infusion devices is solved, and the optimization and stability of the drug delivery process is achieved.

CN120226090APending Publication Date: 2025-06-27FRESENIUS VIAL
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Patent Information

Application Number
CN202380079680.8
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-12-16
Filing Date
2023-12-14
Publication Date
2025-06-27

AI Technical Summary

Technical Problem

When performing a continuous infusion process using multiple infusion devices, the flow rate mismatch between infusion devices leads to fluctuations in dose rates, and problems of under-dose or overdose may occur.

Method used

A system is designed, which comprises at least two adjustable infusion devices and a control system. The control system selects a suitable transition flow routine by storing a plurality of predefined transition flow routines, and controls the flow rate of the infusion device according to the routine to achieve a smooth transition.

Benefits of technology

Through the implementation of this system, the drug delivery process can be optimized, the problems of overdose and insufficient dose can be avoided, and the continuous and stable infusion of the drug can be ensured.

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Abstract

A system (1) for performing a continuous infusion procedure using at least two infusion devices (10A, 10B), the system comprising: a first infusion device (10A) configured to deliver a fluid (F1) from a first medicament container (100A) in an adjustable manner; a second infusion device (10B) configured to deliver a fluid (F2) from a second medicament container (100B) in an adjustable manner; and a control system (11) configured to control the first and second infusion devices (10A, 10B) such that the first infusion device (10A) delivers a fluid (F1) for a first time period and the second infusion device (10B) delivers a fluid (F2) for a second time period. Wherein it is provided that the control system (11) comprises a memory (110) storing a plurality of predefined transition flow routines (R1 to R5), and the control system is configured to: select one predefined transition flow routine of the plurality of predefined transition flow routines (R1 to R5), and controlling the first and second infusion devices (10A, 10B) according to a transition period (TP) between the first and second time periods in accordance with the selected predefined transition flow routine (R1 to R5).
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Description

Technical Field

[0001] The present invention relates to a system for performing a continuous infusion process using at least two infusion devices. Background Art

[0002] Systems with multiple infusion devices can be used to continuously administer a drug to a patient at a relatively constant dosing rate over a relatively long period of time. However, for this purpose, the infusion devices must be operated in a controlled and coordinated manner such that when the drug container associated with the first infusion device is depleted, infusion from a second drug container by a second infusion device is started in order to ensure a continuous and uninterrupted infusion process.

[0003] In this regard, WO 2017 / 012781 A1 provides a solution to the following potentially problematic situation: when the flow rate of the second infusion device is different from the flow rate of the first infusion device, resulting in an increase or decrease in the dosing rate at which residual drug in the common outlet delivery line is delivered to the patient.

[0004] EP 3 222 307A1 describes a start-up routine for one infusion device.

[0005] Optimizing the transition of drug delivery from the first infusion device to the second infusion device is an ongoing task. Summary of the Invention

[0006] It is an object of the present invention to provide a further improved system for performing a continuous infusion process using at least two infusion devices.

[0007] This object is achieved by a system comprising the features of claim 1.

[0008] Accordingly, there is provided a system for performing a continuous infusion process using at least two infusion devices, the system comprising: a first infusion device configured to deliver fluid (e.g., to a common delivery line) from a first drug container in an adjustable manner; a second infusion device configured to deliver fluid (e.g., to a common delivery line) from a second drug container in an adjustable manner; and a control system configured to control the first infusion device and the second infusion device such that the first infusion device delivers fluid during a first time period and the second infusion device delivers fluid during a second time period. It is provided that the control system includes a memory storing a plurality of predefined transition flow routines, and the system is configured to: select one of the plurality of predefined transition flow routines and control the first infusion device and the second infusion device during a transition period between the first time period and the second time period according to the selected predefined transition flow routine.

[0009] This is based on the following findings. Generally, many infusion devices, such as syringe pumps, are very precise and can provide a very stable flow rate. However, a disadvantage of such devices is usually the uncertainty of their starting flow rate. To start an infusion, in the example of a syringe pump, the pusher device pushes the piston of the syringe to move it at a desired speed. But since the syringe piston is usually tightly inserted into the syringe barrel, there is some friction between the rubber part of the syringe piston, also known as the syringe stopper, and the syringe barrel. This friction is generally considered to be a mixture between static friction and dynamic friction. The static friction causes a delay in the piston movement. Since the motion chain between the electric drive device and the syringe pusher device cannot be infinitely rigid, the friction of the syringe will tension the elastic chain until the elastic force equals the static friction force holding the syringe piston. At this time, the syringe piston will move forward, and since the dynamic friction is usually lower than the static friction, a part of the elastic deformation of the power train will be cancelled when a part of this initial deformation is maintained. Therefore, the flow rate may first be delayed and then partially compensated, resulting in continuous underdosing and overdosing situations. In many cases, this effect is small enough to be ignored. However, for certain drugs, such as noradrenaline, even a small overdose can be problematic. However, for other drugs, underdosing is more problematic than overdosing. This is solved by the proposed system, which allows for a transition based on the drug, and this transition enables an optimized transition for any drug.

[0010] The control system, in particular the memory of the control system (or the memory of the control system), can store a drug library that associates each of a plurality of drugs with one or more predefined transition flow routines and / or the corresponding maximum flow rate. This allows for the automatic presentation or selection of a suitable transition flow routine for a given drug. Thereby, an accidental incorrect selection of the transition flow routine can be avoided. Generally, the control system can be adapted to receive an indication of the fluid type (in particular the drug) in the first drug container and / or the second drug container, and select one of the plurality of predefined transition flow routines based on the indication of the fluid type.

[0011] The control system can be adapted to receive an indication of the drug, and optionally, select one of the plurality of predefined transition flow routines based on the indication of the drug, in particular using the drug library. Thereby, the selection of the appropriate transition flow routine can be particularly simple and fail-safe.

[0012] The system may include an interface to receive user input, such as receiving an indication. Optionally, the control system is adapted to select one of a plurality of predefined transition flow routines based on the user input. This enables an easy and intuitive selection. The interface may include an output device such as a display and / or an input device such as a button.

[0013] The control system may be adapted to prohibit selection of at least one of a plurality of predefined transition flow routines for at least one medicine stored in the medicine library. Thus, when certain medicines are used for infusion, inappropriate transition flow routines can be disabled to avoid accidental selection of inappropriate transition flow routines.

[0014] The first infusion device and / or the second infusion device may include an electric drive device. The electric drive device of the first infusion device and / or the second infusion device may be configured to move the pusher device in the pushing direction. Alternatively or additionally, the first infusion device and / or the second infusion device may include one or more measuring devices for measuring one or more parameters associated with the pusher device. This enables a smooth transition from the first infusion device to the second infusion device.

[0015] One or more parameters associated with the pusher device may include one parameter, two parameters, three parameters, or all of the following parameters: the pushing distance traveled by the pusher device in the pushing direction, the force exerted by the pusher device in the pushing direction, the fluid volume delivered by the movement of the pusher device in the pushing direction, and the duration of the movement of the pusher device in the pushing direction. For example, the parameters associated with the pusher device may include the pushing distance traveled by the pusher device in the pushing direction and the force exerted by the pusher device in the pushing direction. These parameters allow for precise control.

[0016] One of the predefined transition flow routines can be an overdose avoidance transition flow routine. The overdose avoidance transition flow routine can be adapted to avoid exceeding a predefined flow rate. For example, according to the overdose avoidance transition flow routine, by means of a control system, in a first phase of a transition period, the electric drive of the second infusion device is controlled to drive the pusher device to move at a first speed, and if one or more parameters associated with the pusher device of the second infusion device exceed a predefined threshold, the electric drive of the second infusion device is controlled to drive the pusher device to move at a second speed that is less than the first speed. Thus, the pusher device of the second infusion device can be quickly operatively connected to the piston, so that fluid can be started to be delivered from the medical container. The gap between the pusher device and the piston and the elasticity in the second infusion device are overcome, so that an effective force transfer from the pusher device to the piston can be achieved. On the other hand, using a predefined threshold (which can be lower than the maximum value of a parameter, such as force or distance) allows avoiding (too high) peak flow rates. The first infusion device can be controlled to gradually or instantaneously reduce the speed of its pusher device at an overdose avoidance flow rate.

[0017] One or more parameters of the pusher device can include the force exerted by the pusher device in the pushing direction (and / or the distance traveled by the pusher device in the pushing direction). One of the predefined transition flow routines can be an underdose avoidance transition flow routine. The underdose avoidance transition flow routine can be adapted to avoid dropping below a predefined flow rate. For example, according to the underdose avoidance transition flow routine, by means of a control system, in a first phase of a transition period, the electric drive of the second infusion device is controlled to drive the pusher device to move at a first speed, and optionally, if it is observed that a parameter (e.g., force) measured to be exerted by the pusher device of the second infusion device corresponds to (e.g., exceeds or drops below) a predefined threshold, the electric drive is controlled to drive the pusher device of the second infusion device to move at a second speed, for example, the second speed is less than the first speed. Similarly, the first infusion device can be controlled to gradually or instantaneously reduce the speed of its pusher device at an underdose avoidance flow rate.

[0018] The predefined threshold of the underdose avoidance transition flow routine can be greater than the predefined threshold of the overdose avoidance transition flow routine. This enables a simple but reliable configuration.

[0019] As an example, the first speed can be in the range between 0.05 mm / s and 2.5 mm / s, for example, between 0.1 mm / s and 0.15 mm / s. These speeds allow for safe operation.

[0020] Optionally, one of the predefined transition flow routines is a smooth overlap transition flow routine. According to the smooth overlap transition flow routine, by means of a control system, the first infusion device can be controlled to gradually reduce the flow rate of fluid delivered from the first drug container, and the second infusion device can be controlled to gradually increase the flow rate of fluid delivered from the second drug container. This allows avoiding excessive dose overshoot and excessive dose undershoot.

[0021] Optionally, one of the predefined transition flow routines is a smooth overlap transition flow routine for minimizing dose overshoot. According to the smooth overlap transition flow routine for minimizing dose overshoot, by means of a control system, at a first moment, the first infusion device is controlled to reduce the flow rate of fluid delivered from the first drug container by a fraction of the target flow rate, and the second infusion device is controlled to start delivering fluid from the second drug container at a flow rate corresponding to the fraction of the target flow rate, and at a second moment, the first infusion device is controlled to stop delivering fluid and the second infusion device is controlled to increase the flow rate to the target flow rate. This enables the administration of fluid at an almost constant flow rate even during the transition. Alternatively or additionally, one of the predefined transition flow routines is a transition flow routine according to which, by means of a control system, at a first moment, the second infusion device is controlled to start delivering fluid from the second drug container, and at a second moment after the first moment, the first infusion device is controlled to reduce or stop delivering fluid from the first drug container. That is to say, according to at least one transition flow routine, the second infusion device can be started before modifying the flow rate of the first infusion device.

[0022] For example, the fraction can be between 1 / 20 and 1 / 2. In particular, the fraction can be 1 / 10. This allows overcoming the static friction of the second infusion device while having little impact on the total fluid flow rate.

[0023] The first infusion device and / or the second infusion device can each be configured as a syringe pump. For syringe pumps, the advantages described herein are particularly prominent.

[0024] In addition, the first drug container and / or the second drug container can each be constituted by the barrel-shaped member of a syringe.

[0025] The control system can be adapted to set the duration of the transition period based on the flow rate of the first infusion device and / or the second infusion device. Description of the Drawings

[0026] The concept underlying the present invention will subsequently be described in more detail by reference to the embodiments shown in the drawings. In the drawings:

[0027] Figure 1 Shows a system for performing a continuous infusion process using at least two infusion devices;

[0028] Figure 2 Shows an infusion device of the system according to Figure 1 ;

[0029] Figure 3 Shows a memory of the infusion device according to Figure 2 ;

[0030] Figure 4 Shows Figure 1 the flow rate of the fluid flow of the infusion device of the system of;

[0031] Figure 5 Shows the force applied by the pusher device of the infusion device of the system of Figure 1 ;

[0032] Figure 6 Shows the flow rate and time in the case of a smooth overlapping transition flow routine using the system of Figure 1 ;

[0033] Figure 7 Shows the flow rate and time in the case of a smooth overlapping transition flow routine with minimized overdose using the system of Figure 1 ; and

[0034] Figure 8 Shows the flow rate and time in the case of another transition flow routine using the system of Figure 1 ; DETAILED DESCRIPTION

[0035] Subsequently, a system for performing a continuous infusion process using at least two infusion devices 10A, 10B will be described. The embodiments described herein should not be construed as limiting the scope of the present invention.

[0036] Figure 1 Shows a schematic diagram of a system 1 including two infusion devices 10A, 10B, namely a first infusion device 10A and a second infusion device 10B, in the illustrated embodiment. The first infusion device 10A is configured to deliver a fluid F1 from a first drug container 100A in an adjustable manner. The second infusion device 10B is configured to deliver a fluid F2 from a second drug container 100B in an adjustable manner. The fluid F1 in the first drug container 100A and the fluid F2 in the second drug container 100B can be of the same type (e.g., the same drug).

[0037] In this example, the first infusion device 10A is configured to deliver fluid F1 from the first drug container 100A to the common delivery line 14 in an adjustable manner via the first delivery line 13A towards the patient P, and the second infusion device 10A is configured to deliver fluid F2 from the second drug container 100B to the common delivery line 14 in an adjustable manner via the second delivery line 13B towards the patient P.

[0038] Each of the infusion devices 10A, 10B is configured as a syringe pump and includes a syringe 105, which may be replaceable. Each syringe 105 includes a cylindrical barrel forming the respective drug container 100A, 100B and a piston 109 received in the cylindrical barrel. The respective syringes 105 are received in suitable holding means of the associated infusion devices 10A, 10B, for example. Each infusion device 10A, 10B includes an electric drive device 101 for continuously pushing the respective piston 109 into the cylindrical barrel to deliver the respective fluid F1, F2 received in the respective cylindrical barrel towards the patient P, for example, at a constant flow rate.

[0039] The system 1 further includes a control system 11 configured to control the first infusion device 10A and the second infusion device 10B such that the first infusion device 10A delivers fluid F1 during a first time period and the second infusion device 10B delivers fluid F2 during a second time period. The control system 11 generally includes a memory 110 and at least one processor 111. In the example shown, the control system 11 includes a first control device 112A that is part of the first infusion device 10A and a second control device 112B that is part of the second infusion device 10B. Each of the first control device 112A and the second control device 112B includes a memory 110 and a processor 111. The first control device 112A and the second control device 112B are communicatively coupled via a communication line 113. However, in other examples, the control system 11 may be located only at one of the control devices 112A, 112B, or may be formed as a device external to both the first infusion device 10A and the second infusion device 10B or in a device located external to both the first infusion device 10A and the second infusion device 10B. The control system 11 is communicatively coupled to the electric drive devices 101 of the first infusion device 10A and the second infusion device 10B via respective communication lines 114. Thus, the electric drive devices 101 of the first infusion device 10A and the second infusion device 10B are controlled by the control system 11.

[0040] System 1 is set up to perform a continuous infusion operation. To this end, both the first delivery line 13A and the second delivery line 13B lead to a common delivery line 14. This connection can be, for example, a direct fluid connection with a Y-shaped adapter. An optional relay device 15 can control the flow from the first delivery line 13A and the second delivery line 13B to the common delivery line 14. The common delivery line 14 can be connected, for example, to the patient P by means of a suitable injection needle or the like, so that the fluid F1 from the first drug container 100A and the fluid F2 from the second drug container 100B can be administered to the patient P via the common delivery line 14.

[0041] (Continuous) infusion process starts, for example, in the first infusion phase, in which the first infusion device 10A delivers the fluid F1, in particular a drug, from its first drug container 100A via the first delivery line 13A at a first flow rate, so that the fluid F1 is delivered to the patient P at the first flow rate.

[0042] For example, once the first drug container 100A is almost depleted, the infusion process will switch to the second infusion device 10B.

[0043] At the end of the first infusion phase (for example, when the first drug container 100A is almost depleted), a control signal is issued by, for example, the processor 111 of the first infusion device 10A and transmitted to the processor 111 of the second infusion device 10B. The control signal causes the operation of the first infusion device 10A to stop and the operation of the second infusion device 10B to start. Optionally, the relay device 15 is also switched simultaneously (for example, by switching a suitable flow switching device included in the relay device 15).

[0044] To optimize the transition of various possible drugs used for infusion, the control system 11 includes a memory 110 (for example, the memory 110 of the first infusion device 10A and / or the memory of the second infusion device 10B and / or a memory external to the infusion device) that stores a plurality of predefined transition flow routines R1 to R5, and is configured to select one of the plurality of predefined transition flow routines R1 to R5, and control the first infusion device 10A and the second infusion device 10B during the transition period TP between the first time period and the second time period according to the selected predefined transition flow routine R1 to R5.

[0045] Each of the infusion devices 10A, 10B includes at least one measuring device 103 for measuring one or more parameters, such as the pushing distance X (see Figure 5 ) traveled by the pusher device 102 in the pushing direction D, the force F (see Figure 5) The volume of fluid delivered by the movement of the pusher device 102 in the pushing direction D and / or the duration of the movement of the pusher device 102 in the pushing direction D. Using one or more parameters, the transition between the first infusion device and the second infusion device can be improved.

[0046] Although Figure 1 the infusion devices 10A, 10B are shown very schematically, Figure 2 it illustrates an alternative, more specific design of the first infusion device 10A. The first infusion device 10A and the second infusion device 10B can have the same design. The first infusion device 10A has a housing 104 and a receiving portion 107 arranged on the housing 104 for receiving a syringe 105 therein. The barrel of the syringe 105 is connected to the first delivery line 13A via a connection member 106.

[0047] To mount the syringe 105 on the receiving portion 107 of the first infusion device 10A, the barrel of the syringe 105 is placed in the receiving portion 107 and the barrel of the syringe 105 is mechanically connected to the housing 104 by means of a fixing device 108. By means of the fixing device 108, for example a fixing device 108 consisting of releasable clamping elements, the barrel is fixed within the receiving portion 107 such that the barrel remains in place within the receiving portion 107.

[0048] To deliver the medical fluid F1 received in the barrel, the piston 109 of the syringe 105 can be pushed into the barrel in the pushing direction D. For this purpose, the first infusion device 10A includes a pusher device 102 arranged movably within a guiding device and connected to an electric drive device 101.

[0049] To operate the first infusion device 10A, the syringe 105 is installed and the pusher device 102 is moved (manually) towards the piston head of the piston 109 until the pusher device 102 abuts against the piston head. To perform the infusion process, the pusher device 102 is then moved electrically in the pushing direction D to move the piston 109 into the barrel for delivering the fluid F1 received in the barrel via the delivery line 13A towards the patient P.

[0050] The first infusion device 10A further includes a man-machine interface 12 for outputting information and inputting instructions.

[0051] Figure 3 It shows the contents of the memory 110 of the control system 11, for example the memory 110 of the first infusion device 10A and / or the second infusion device 10B.

[0052] The memory 110 stores a plurality of predefined transition flow routines R1 to R5 and a drug library L, which will be described in further detail below.

[0053] The memory 110 also stores an instruction C, which, when executed by one or more processors of the control system 11, such as the processors 111 of the first infusion device 10A and the second infusion device 10B, causes the processor to select one of the stored plurality of predefined transition flow routines R1 to R5 and control the first infusion device 10A and the second infusion device 10B during a transition period TP between a first time period and a second time period according to the selected predefined transition flow routine R1 to R5.

[0054] Figure 4 is Figure 1 a graph of the flow rate FR versus time T of one of the infusion devices 10A, 10B and illustrates the effects of static and dynamic friction in the syringe pump. As further mentioned above, the syringe piston 109 is typically tightly inserted into the syringe barrel, and the friction between these components is a mixture of static and dynamic friction. Static friction causes a delay in piston movement, as can be seen in the left portion of the figure. Once the elastic force equals the static friction force holding the syringe piston, the syringe piston 109 moves forward more quickly, so the flow rate FR is first delayed and then partially compensated, resulting in continuous underdosing and overdosing situations, with the overdosing visible as a peak in Figure 4 After this startup phase, the flow rate FR is relatively constant.

[0055] Due to this continuous underdosing and overdosing, making the transition as smooth as possible can be a challenge. Additionally, some drugs cannot be administered in the case of overdosing, and other drugs cannot be administered in the case of underdosing. Other drugs can tolerate a small amount of overdosing or underdosing, but generally may require as constant a flow rate as possible.

[0056] For example, for some drugs with a long half-life, the exact moment of drug administration is not of primary importance. For those drugs, generally what is mainly important is the quantity and rate. If the start time of administration is 5 minutes earlier or later than originally planned, this may have little or no impact on the effectiveness of the treatment. For some other drugs, their onset is so rapid and sometimes so critical that it is very important to ensure that the patient receives the drug immediately when such a drug is selected by the medical team. For such drugs, it may be more preferable to receive more of the drug at the correct time than to receive the correct dose with a delay. On the contrary, for some other drugs, there may be concerns about toxic effects in the case where the infusion dose exceeds the initially expected dose. These problems also exist in the transition of the channel relay device.

[0057] To address these issues, the memory 110 stores a plurality of predefined transition flow routines R1 to R5. In this example, the plurality of predefined transition flow routines R1 to R5 include:

[0058] - An overdose avoidance transition flow routine R1,

[0059] - An underdose avoidance transition flow routine R2,

[0060] - A smooth overlap transition flow routine R3,

[0061] - A smooth overlap transition flow routine R4 for overdose minimization, and

[0062] - Another transition flow routine R5.

[0063] Now turning to Figure 5 , the overdose avoidance transition flow routine R1 and the underdose avoidance transition flow routine R2 will be described. Two curves illustrate two independent exemplary pumping processes of the second infusion device 10B.

[0064] Figure 5 Shown is the force F applied by the pusher device 102 of the second infusion device 10B in the pushing direction D and the pushing distance X traveled by the pusher device 102 along the pushing direction D.

[0065] As the pushing distance X increases, first, the resultant force F increases until it reaches the maximum force (when static friction is reached). Thereafter, the force F eventually decreases (see the following example curve) and then remains constant.

[0066] To avoid an overdose, the overdose avoidance transition flow routine R1 is executed as follows (see the lower curve in Figure 5 ): In the first stage of the transition period TP, the electric drive device 101 of the second infusion device 10B is controlled to drive the pusher device 102 to move at a first speed to pass through the underdose region more quickly, and if (a) a measured parameter associated with the pusher device 102 of the second infusion device 10B, in this example the force F, exceeds a predefined threshold F 最小 , then the electric drive device 101 of the second infusion device 10B is controlled to drive the pusher device 102 to move at a second speed. The first speed is greater than the second speed. At the same time, the first infusion device can correspondingly reduce its flow rate.

[0067] Optionally, performing an over-dose avoidance transition flow routine R1 (or an under-dose avoidance transition flow routine R2 or another transition flow routine) includes monitoring the distance X traveled by the pusher device 102 of the second infusion device 10B. The over-dose avoidance transition flow routine R1 (or other transition flow routine) may include comparing the distance X traveled with a predefined threshold distance X 最大 for comparison. Exceeding the predefined threshold distance X 最大 may trigger a change in the speed of the pusher device 102. For example, when the threshold force F 最小 has not been reached but the threshold distance X 最大 has been reached, the electric drive device 101 may be controlled to drive the pusher device 102 of the second infusion device 10B to move at a second speed.

[0068] On the other hand, to avoid under-dosing, the under-dose avoidance transition flow routine R2 is performed as follows (see the upper curve in Figure 5 ): In the first stage of the transition period TP, the electric drive device 101 of the second infusion device 10B is controlled to drive the pusher device 102 to move at a (higher) first speed (e.g., the same as the first speed in the over-dose avoidance transition flow routine R1), and if it is observed that the measured force F exerted by the pusher device 102 of the second infusion device 10B exceeds a predefined threshold F 最大 , then the electric drive device 101 is controlled to drive the pusher device 102 of the second infusion device 10B to move at a (lower) second speed (e.g., the same as the second speed in the over-dose avoidance transition flow routine R1). At the same time, the first infusion device may correspondingly reduce its flow rate.

[0069] The threshold F of the under-dose avoidance transition flow routine R2 最大 is greater than the threshold F of the over-dose avoidance transition flow routine R1 最小 .

[0070] The first speed may be in the range of 0.05 mm / s to 2.5 mm / s, for example, in the range of 0.1 mm / s to 0.15 mm / s.

[0071] Now turning to Figure 6 , the smooth overlapping transition flow routine R3 will be described. Figure 6 Shows the flow rate FR (solid line) of the first infusion device 10A, the flow rate FR (dotted line) of the second infusion device 10B, and the total flow rate FR (dashed line) of the first infusion device 10A and the second infusion device 10B versus time T.

[0072] The smooth overlapping transition flow routine R3 is executed as follows: Control the first infusion device 10A to gradually (here: linearly) reduce the flow rate FR of the fluid F1 delivered from the first drug container 100A during the transition period TP, and control the second infusion device 10B to gradually (here: ignoring the start-up phase, linearly) increase the flow rate FR of the fluid F2 delivered from the second drug container 100B. As a result, the flow rate FR is relatively constant before, during, and after the transition period TP. However, a small dose overage may persist. This may be negligible for some drugs, but not for others.

[0073] Therefore, Figure 7 FIG. illustrates a smooth overlapping transition flow routine R4 for minimizing dose overage. According to this smooth overlapping transition flow routine R4 for minimizing dose overage: At a first moment, control the first infusion device 10A to reduce the flow rate FR of the fluid F1 delivered from the first drug container 100A by a fraction of the target flow rate FR (e.g., 10% or 5%), and control the second infusion device 10B to start delivering the fluid F2 from the second drug container 100B at a flow rate FR corresponding to the fraction of the target flow rate. Thus, the first infusion device 10A gradually reduces to, for example, 90%, and the second infusion device 10B gradually increases to 10%, so that the sum remains at 100%. At a later second moment, control the first infusion device 10A to stop delivering the fluid F1, and control the second infusion device 10B to increase the flow rate FR to the target flow rate (100%). Thereby, the impact of start-up can be greatly reduced, and an almost constant total flow rate FR can be achieved. Thereby, it can be ensured that the total flow rate FR does not drop below a given fraction, such as 90%.

[0074] Optionally, the duration of the transition period TP depends on the (target) flow rate FR. The transition period is long enough to ensure that the flow rate of the second infusion device 10B increases before the first infusion device 10A stops. For example, the transition period TP can last 5 minutes or less, or 10 minutes or less. The increase and / or decrease can be controlled step by step (e.g., 10 steps in 30s).

[0075] According to another transition flow routine R5, at a first moment, control the second infusion device 10B to start delivering the fluid F2 from the second drug container 100B, and at a second moment after the first moment, control the first infusion device 10A to reduce or stop delivering the fluid F1 from the first drug container 100A. This can be combined with any of the transition flow routines R1 to R4. For example, thereby, it is possible to reduce or avoid Figure 6 and Figure 7 the small dose shortage shown in.

[0076] Such a flow routine is shown in Figure 8 . In Figure 8 , the pumping of the first infusion device 10A remains unchanged, while at a first moment, the second infusion device 10B is controlled to start delivering fluid F2 from the second drug container 100B (see the dotted line). Thus, during a transition period TP starting at the first moment, the total flow rate FR (see the dashed line) does not drop below the target flow rate, thus avoiding underdosing. However, to minimize overdosing, the second infusion device 10B is controlled to start delivering fluid from the second drug container 100B at a flow rate corresponding to a fraction of the target flow rate.

[0077] At a second moment, the first infusion device 10A is simultaneously controlled to stop (or gradually reduce) delivering fluid F1 from the first drug container 100A (see the solid line), and the second infusion device 10B is controlled to start (or gradually increase) delivering fluid F2 from the second drug container 100B at the target flow rate (see the dotted line). The delay between the first moment and the second moment is predefined. The delay is set such that the peak flow rate FR of the second infusion device 10B occurs within the transition period TP. This flow routine may also be referred to as a smooth overlapping transition flow routine for avoiding underdosing.

[0078] Some or all of these transition flow routines R1 to R5 can be stored in the memory 110.

[0079] Optionally, the transition flow routines R1 to R5 can be selected by instructions input into the interface 12. Alternatively or additionally, the system 1 can include a drug library L. The drug library L associates each of a plurality of drugs with a corresponding one of a plurality of predefined transition flow routines R1 to R5. Thus, when the drugs in the drug containers 100A, 100B are input via the interface 12 or automatically detected by the first infusion device 10A and / or the second infusion device 10B, the correct transition flow routines R1 to R5 can be selected. On the other hand, the control system 11 can be adapted to prohibit the selection of at least one of the plurality of predefined transition flow routines R1 to R5 for at least one drug stored in the drug library L. Thus, the transition flow routines R1 to R5 that are not applicable to a given drug cannot be accidentally selected.

[0080] The system 1 can also have a drug error reduction system, wherein for a given drug, a corresponding maximum flow rate FR can be stored in the drug library L.

[0081] Thus, this solution allows the caregiver to manually or automatically select an appropriate routine based on the drug to be administered.

[0082] The concept of the present invention is not limited to the embodiments described above, but can be implemented in different ways.

[0083] List of reference numerals

[0084] 1 System

[0085] 10A, 10B Infusion device

[0086] 100A, 100B Drug container

[0087] 101 Electric drive device

[0088] 102 Pusher device

[0089] 103 Measuring device

[0090] 104 Housing

[0091] 105 Syringe

[0092] 106 Connector

[0093] 107 Receiving part

[0094] 108 Fixing device

[0095] 109 Piston

[0096] 11 Control system

[0097] 110 Memory

[0098] 111 Processor

[0099] 112A, 112B Control device

[0100] 113 Communication line

[0101] 114 Communication line

[0102] 12 Interface

[0103] 13A, 13B Delivery pipeline

[0104] 14 Common delivery pipeline

[0105] 15 Relay device

[0106] C Instruction

[0107] D Pushing direction

[0108] F Force

[0109] F1, F2 Fluid

[0110] F 最小 、F 最大 Threshold value

[0111] FR Flow rate

[0112] L Medicine library

[0113] P Patient

[0114] R1 to R5 Transition flow routine

[0115] T Time

[0116] TP Transition period

[0117] X, X 最大 Distance

Claims

1. A system (1) for performing a continuous infusion process using at least two infusion devices (10A, 10B), the system comprising: - a first infusion device (10A) configured to deliver a fluid (F1) from a first drug container (100A) in an adjustable manner, - a second infusion device (10B) configured to deliver a fluid (F2) from a second drug container (100B) in an adjustable manner, and - a control system (11) configured to control the first infusion device (10A) and the second infusion device (10B) such that the first infusion device (10A) delivers the fluid (F1) during a first time period and the second infusion device (10B) delivers the fluid (F2) during a second time period, wherein, the control system (11) includes a memory (110) storing a plurality of predefined transition flow routines (R1 to R5), and is configured to: - select one of the plurality of predefined transition flow routines (R1 to R5), and - control the first infusion device (10A) and the second infusion device (10B) according to the selected predefined transition flow routine (R1 to R5) during a transition period (TP) between the first time period and the second time period.

2. The system (1) according to claim 1, wherein, The memory of the control system (11) stores a drug library (L) that associates each of a plurality of drugs with one or more of the plurality of predefined transition flow routines (R1 to R5) and / or a corresponding maximum flow rate.

3. The system (1) according to claim 2, characterized in that, The control system (11) is adapted to receive an indication of a drug and is adapted to use the drug library (L) to select one of the plurality of predefined transition flow routines (R1 to R5) based on the indication of the drug.

4. The system (1) according to one of the preceding claims, characterized in that, Including an interface (12) for receiving user input, wherein the control system (11) is adapted to select one of the plurality of predefined transition flow routines (R1 to R5) based on the user input.

5. The system (1) according to claim 2 or 3 and according to claim 4, characterized in that, The control system (11) is adapted to prohibit selection of at least one of the plurality of predefined transition flow routines (R1 to R5) for at least one drug stored in the drug library (L).

6. The system (1) according to one of the preceding claims, characterized in that, The first infusion device (10A) and / or the second infusion device (10B) includes an electric drive device (101) and at least one measuring device (103), the electric drive device (101) being configured to move a pusher device (102) along a pushing direction (D), the at least one measuring device (103) being used to measure one or more parameters associated with the pusher device (102).

7. The system (1) according to claim 6, characterized in that, The one or more parameters associated with the pusher device (102) include: - The pushing distance (X) traveled by the pusher device (102) along the pushing direction (D), and / or - The force (F) exerted by the pusher device (102) in the pushing direction (D), and / or - The fluid volume transported by the movement of the pusher device (102) along the pushing direction (D), and / or - The duration of the movement of the pusher device (102) along the pushing direction (D).

8. The system (1) according to claim 6 or 7, characterized in that, One of the predefined transition flow routines (R1 to R5) is the overdose avoidance transition flow routine (R1). According to the overdose avoidance transition flow routine (R1), by means of the control system (11): - In the first stage of the transition period (TP), control the electric drive device (101) of the second infusion device (10B) to drive the pusher device (102) to move at a first speed, and - If one or more parameters measured associated with the pusher device (102) of the second infusion device (10B) exceed a predefined threshold (F 最小 ), then control the electric drive device (101) of the second infusion device (10B) to drive the pusher device (102) to move at a second speed smaller than the first speed.

9. The system (1) according to one of claims 6 to 8, characterized in that The one or more parameters associated with the pusher device (102) include the force (F) exerted by the pusher device (102) in the pushing direction (D). One of the predefined transition flow routines (R1 to R5) is the underdose avoidance transition flow routine (R2). According to the underdose avoidance transition flow routine (R2), by means of the control system (11): - In the first stage of the transition period (TP), control the electric drive device (101) of the second infusion device (10B) to drive the pusher device (102) to move at a first speed, and - If it is observed that the measured force (F) applied by the pusher device (102) of the second infusion device (10B) corresponds to a predefined threshold (F 最大 ), then control the electric drive device (101) to drive the pusher device (102) of the second infusion device (10B) to move at a second speed smaller than the first speed.

10. The system (1) according to claim 8 and according to claim 9, characterized in that, The predefined threshold (F 最大 ) of the under-dose avoidance transition flow routine (R2) is greater than the predefined threshold (F 最小 ) of the over-dose avoidance transition flow routine (R1).

11. The system (1) according to claim 9 or 10, characterized in that, The first speed is in the range between 0.05 mm / s and 2.5 mm / s, for example, between 0.1 mm / s and 0.15 mm / s.

12. The system (1) according to one of the preceding claims, characterized in that, One of the predefined transition flow routines (R1 to R5) is the smooth overlap transition flow routine (R3). According to the smooth overlap transition flow routine (R3), by means of the control system (11): - Control the first infusion device (10A) to gradually reduce the flow rate of the fluid delivered from the first drug container (100A), and - Control the second infusion device (10B) to gradually increase the flow rate of the fluid delivered from the second drug container (100B).

13. The system (1) according to one of the preceding claims, characterized in that, One of the predefined transition flow routines (R1 to R5) is the smooth overlap transition flow routine for overdose minimization (R4). According to the smooth overlap transition flow routine for overdose minimization (R4), by means of the control system (11): - At a first moment, control the first infusion device (10A) to reduce the flow rate of the fluid delivered from the first drug container (100A) by a fraction of the target flow rate, and control the second infusion device (10B) to start delivering fluid from the second drug container (100B) at a flow rate corresponding to the fraction of the target flow rate, and - At a second moment, control the first infusion device (10A) to stop delivering fluid, and control the second infusion device (10B) to increase the flow rate to the target flow rate; And / or one of the predefined transition flow routines (R1 to R5) is the transition flow routine (R5), according to which, by means of the control system (11): - At a first moment, control the second infusion device (10B) to start delivering fluid from the second drug container (100B), and - At a second moment after the first moment, control the first infusion device (10A) to reduce or stop delivering fluid from the first drug container (100A).

14. The system (1) according to claim 13, characterized in that, The fraction is between 1 / 20 and 1 / 2, in particular the fraction is 1 / 10.

15. The system (1) according to one of the preceding claims, characterized in that, The first infusion device (10A) and the second infusion device (10B) are each configured as a syringe pump.

Citation Information

Patent Citations

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