Medical infusion device comprising leak determination module

Abstract

The present invention relates to a medical infusion device comprising: a reservoir for containing a liquid medicament; a cannula assembly; a fluid line; a driving mechanism; a dispensing member for dispensing a medicament from a reservoir through the fluid line and the cannula assembly; and a leak determination module. In order to more conveniently determine a leak of a liquid drug, the leak determination module comprises an electronic probe configured to receive odorant and / or flavor molecules of the liquid drug, and wherein the leak determination module further comprises evaluation electronics configured to determine the presence of an odor and / or flavor of the liquid medicament based on the read content of the at least one electronic probe.

Description

[0001] The present invention relates to a medical infusion device, which includes a reservoir configured to contain liquid medicine, a cannula assembly, a fluid line fluidly connected to the reservoir and the cannula assembly, a driving mechanism, a dispensing member that dispenses the liquid medicine from the reservoir through the fluid line and the cannula assembly when actuated by the driving mechanism, and a leakage determination module configured to determine whether the liquid medicine has leaked from at least one of the reservoir, the fluid line or the cannula assembly.

[0002] Medical infusion devices are used to provide liquid medicine intended to improve the health of the patient to the user of the infusion device. Therefore, the liquid medicine contained in the reservoir of the medical infusion device is distributed through the fluid line and the cannula assembly by a dispensing member actuated by a drive mechanism. However, sometimes a failure occurs, which causes the liquid medicine to leak unexpectedly from one or more of the reservoir, the fluid line or the cannula assembly. For example, the leakage may be caused by a mechanical impact to the medical infusion device (specifically a mechanical impact to a component containing or guiding the liquid medicine), or an improper assembly of the medical infusion device.

[0003] Leakage may result in failure to provide the desired amount of liquid medicine to the user of the medical infusion device. The user usually does not notice the leakage, especially the leakage of a small amount of liquid medicine. This may result in insufficient or even excessive dosage of the liquid medicine. The latter may occur in the following situations: the desired effect of the liquid medicine is lost and the medical infusion device is operated to compensate for the leakage of the liquid medicine, but the amount of the underdosed liquid medicine actually provided is unknown to the user or to the semi- / fully automatic delivery algorithm of the medical infusion pump (if the medical infusion pump is operated with such an algorithm).

[0004] Therefore, the medical infusion devices known so far include a leakage determination module, which is configured to determine that the liquid drug has leaked out of at least one of the reservoir, the fluid line or the cannula assembly. However, those leakage determination modules of the medical infusion pumps known so far are test strips or humidity sensors. The use of the test strips is cumbersome for the users of the medical infusion pumps, because the indication of the leakage can only be clearly seen by frequently checking the test strips. In addition, the test strips are non-specific for the type of liquid that wets the test strips. Therefore, depending on the user's environment, the test strips may erroneously indicate the leakage of the liquid drug due to the ingress of water or moisture. This is also true when using humidity sensors instead of test strips.

[0005] Therefore, it is an object of the present invention to provide a medical infusion device which avoids at least one of the problems associated with medical devices known from the prior art. In particular, it is an object of the present invention to provide a medical infusion device which allows a more convenient determination of leakage of a liquid drug.

[0006] At least one of the above objects is solved by providing the subject matter disclosed in the claims and throughout the specification.

[0007] According to a first aspect, a medical infusion device is provided. The medical infusion device includes a reservoir configured to contain a liquid drug, a cannula assembly, a fluid line in fluid communication with the reservoir and the cannula assembly, a drive mechanism, a dispensing member that dispenses the liquid drug from the reservoir through the fluid line and the cannula assembly when actuated by the drive mechanism, and a leakage determination module configured to determine leakage of the liquid drug from at least one of the reservoir, the fluid line, or the cannula assembly, wherein the leakage determination module includes an electronic probe configured to receive odor molecules and / or flavor molecules of the liquid drug, and wherein the leakage determination module further includes an evaluation electronic device configured to determine the presence of an odor and / or flavor of the liquid drug based on a reading of the at least one electronic probe.

[0008] During use, the liquid drug is contained in a reservoir of the medical infusion device, wherein when the drive mechanism is actuated, the dispensing member forces the liquid drug to flow out of the reservoir into the fluid line and ultimately flow through the cannula assembly. Leakage of the liquid drug is any unintended outflow of the liquid drug from one of the reservoir, the fluid line, or the cannula assembly. The cannula assembly may include a septum and a connecting needle that pierces the septum during use to provide fluid communication from the reservoir via the fluid line via the connecting line through the septum to the cannula.

[0009] The liquid drug leaking out of at least one of the reservoir, the fluid line, and the cannula assembly is determined by a leakage determination module. The leakage determination module is configured to detect the odor and / or flavor of the liquid drug. The leakage determination module includes an electronic probe configured to receive the odor molecules and / or flavor molecules of the liquid drug. That is, the odor molecules and / or flavor molecules of the liquid drug leaking out of at least one of the reservoir, the fluid line, or the cannula assembly are received by the electronic probe, wherein once the odor molecules and / or flavor molecules of the liquid drug are received, an electronic signal is generated by the electronic probe.

[0010] The electronic signal generated by the electronic probe, i.e., the reading of the electronic probe, is received by the evaluation electronics of the leakage determination module. The evaluation electronics determines the presence of odor molecules and / or flavor molecules based on the reading of the electronic probe. The electronic probe and the evaluation electronics together form an electronic sensing device configured to detect the odor and / or flavor of the liquid medicine.

[0011] According to an embodiment of the present invention, the electron probe includes at least one of a metal oxide semiconductor ("MOSFET"), a conductive polymer, a non-conductive polymer with added conductive material (such as carbon black), a quartz crystal microbalance ("QCM"), a surface acoustic wave ("SAW"), and a mass spectrometer.

[0012] In the sense of the present invention, a metal oxide semiconductor is a transistor that amplifies or switches electronic signals. Odor molecules and / or flavor molecules received by the probe will be positively or negatively charged, thus changing the electric field inside the MOSFET. Odor molecules and / or flavor molecules will change the MOSFET signal, which can not be interpreted by the evaluation electronics.

[0013] Conductive polymers in the sense of the present invention are organic polymers which conduct electricity, wherein upon receipt of odor molecules and / or flavor molecules, respectively, the conductivity of the polymer changes, thereby generating a sensor signal which can be interpreted by evaluation electronics.

[0014] Likewise, in the sense of the present invention, a non-conductive polymer to which a conductive material such as, for example, carbon black is added will also change the conductivity when receiving odor and / or flavor molecules. The change in conductivity leads to a change in the sensor signal, which can be interpreted by the evaluation electronics.

[0015] In the sense of the present invention, a quartz crystal microbalance measures the change in mass per unit area by measuring the change in the frequency of a quartz crystal resonator. Upon receipt of odor molecules and / or flavor molecules, the mass per unit area changes, which results in a change in the frequency of the quartz crystal resonator. The change in frequency generates a sensor signal that can be interpreted by evaluation electronics.

[0016] Furthermore, in the sense of the present invention, a surface acoustic wave is a micro-electromechanical system that relies on the modulation of surface acoustic waves to sense the deposition of odor molecules and / or flavor molecules. For example, an acoustic wave is traveling along the surface of an elastic material, the acoustic wave having an amplitude that decays exponentially with the depth of penetration into the material. Upon receiving the odor molecules and / or flavor molecules, the physical properties of the micro-mechanical system change, which affects the surface acoustic waves. Thus, the sensor signal generated based on the changes in the surface acoustic waves can be interpreted by the evaluation electronics to determine the presence of odor molecules and / or flavor molecules.

[0017] In the sense of the present invention, the evaluation electronic device comprises hardware and / or software configured to interpret the reading content of the at least one electronic probe and / or the electronic reference probe. For example, the evaluation electronic device can be a microprocessor or a part thereof. According to an embodiment, the evaluation electronic device for interpreting the reading content of the at least one electronic probe and / or the at least one electronic reference probe is configured as pattern recognition. According to an embodiment, the evaluation electronic device for interpreting the reading content of the at least one electronic probe and / or the at least one electronic reference probe can be trained by using a neural network.

[0018] According to an embodiment of the present invention, the at least one electronic probe is located at one or more positions on the reservoir or outside the reservoir, and / or at one or more positions on the cannula assembly or outside the cannula assembly, and / or at one or more positions on the fluid line or outside the fluid line. Once the liquid drug has leaked out of at least one of the reservoir, the fluid line or the cannula assembly, the flow direction of the liquid drug is unknown.

[0019] According to an embodiment of the present invention, the medical infusion device includes at least one discharge channel configured to guide the liquid medicine leaking from at least one of the reservoir, fluid line or cannula assembly toward the at least one electronic probe of the leakage determination module. The at least one discharge channel guides the liquid medicine leaking from at least one of the reservoir, fluid line or cannula assembly to the at least one probe. Therefore, the at least one probe can be arranged at any position in the medical infusion device. Specifically, the at least one probe can be arranged at a position away from the reservoir, fluid line or cannula assembly. The at least one probe can be located at a position different from the position prone to leakage, for example, the transition between the reservoir and the fluid line, the transition between the fluid line and the cannula assembly, the inlet of the reservoir (if present) or the outlet of the reservoir. In addition, the medical infusion device can include a plurality of discharge channels, each of which is configured to guide the liquid medicine leaking from at least one of the reservoir, fluid line or cannula assembly toward the at least one probe. Therefore, at least one probe can be used to detect liquid medicine that may leak from different positions of at least one of the reservoir, fluid line or cannula assembly.

[0020] According to an embodiment of the present invention, the medical infusion device includes at least one discharge chamber configured to collect liquid medicine leaking out from at least one of a reservoir, a fluid line or a cannula assembly, wherein the discharge chamber includes the at least one electronic probe of the leakage determination module. According to another embodiment, the at least one discharge chamber is in fluid communication with the at least one discharge channel. The liquid medicine collected in the discharge chamber is guided from the discharge chamber toward the electronic probe through the discharge channel, or the at least one discharge channel guides the liquid medicine to leak out from at least one of a reservoir, a fluid line or a cannula assembly into the at least one discharge chamber, wherein the discharge chamber includes the at least one electronic probe of the leakage determination module. Therefore, instead of arranging the at least one electronic probe at or near a position prone to leakage, the at least one probe is arranged at a position within a guidance system, the guidance system including the at least one discharge channel and / or the at least one discharge chamber. This allows the medical infusion device to have a more flexible configuration, which is particularly beneficial for the desired form factor obtained by the medical infusion device.

[0021] According to an embodiment of the present invention, the at least one electronic probe is located at one or more positions on the medical infusion device or outside the medical infusion device, wherein the at least one electronic probe is configured and positioned to receive odor molecules and / or flavor molecules outside the medical infusion device. By way of example only, the at least one electronic probe may be integrated in the housing of the medical infusion device or located at the housing of the medical infusion device. Liquid medicine leaked from at least one of the reservoir, fluid line, or cannula assembly may flow out of the medical infusion device along the periphery of the medical infusion device in some way, or the liquid medicine may accumulate outside the medical infusion device during use of the medical infusion device. For example, between the medical infusion device and the patient's body, or near it.

[0022] According to an embodiment of the present invention, the leakage determination module includes at least one electronic reference probe configured and arranged to receive the odor molecules and / or flavor molecules of the liquid medicine outside the medical infusion device, and wherein the evaluation electronic device is further configured to determine the presence of the odor and / or flavor of the liquid medicine based on the reading content of the at least one electronic reference probe and the reading content of the at least one electronic probe. During the use of the medical infusion device, the liquid medicine may be present outside the medical infusion device without the need for at least one of the reservoir, fluid line or cannula assembly to leak, for example due to previous leakage, misoperation or contamination. The reference probe provides the reading content of the odor molecules and / or flavor molecules of the liquid medicine that may be present outside the medical infusion device. The evaluation electronic device determines whether the liquid medicine is leaking out of at least one of the reservoir, fluid line or cannula assembly based on the reading content of the electronic probe and the electronic reference probe. For example, when the reading content of the electronic probe indicates the presence of the odor molecules and / or flavor molecules of the liquid medicine, and the reading content of the electronic reference probe does not indicate the presence of the odor molecules and / or flavor molecules, the evaluation electronic device determines that the liquid medicine has leaked out of at least one of the reservoir, fluid line or cannula assembly. In addition, for example, in the case where both the reading of the at least one electronic probe and the reading of the at least one electronic reference probe indicate the presence of odor molecules and / or flavor molecules, the evaluation electronics determines that no liquid drug has leaked out of at least one of the reservoir, fluid line, or cannula assembly. Likewise, in the case where, for example, only the reading of the at least one electronic reference probe indicates the presence of odor molecules and / or flavor molecules of the liquid drug, the evaluation electronics determines that no liquid drug has leaked out of at least one of the reservoir, fluid line, or cannula assembly.

[0023] While the at least one electronic probe is intended to indicate the presence of odor molecules and / or flavor molecules to confirm a leak, the at least one electronic reference probe is intended to indicate the absence of odor molecules and / or flavor molecules in order to prevent false positive conclusions.

[0024] According to an embodiment of the present invention, the at least one electronic probe and / or the at least one electronic reference probe (if present) is configured to receive volatile odor molecules and / or volatile flavor molecules of the liquid medicine. According to an embodiment, the at least one electronic probe and / or the at least one electronic reference probe (if present) is configured to receive gaseous odor molecules and / or gaseous flavor molecules.

[0025] According to an embodiment of the present invention, a medical infusion device includes a user interface configured to indicate the presence of a leak of a liquid drug to a user of the medical infusion device based on a determination of a leak determination module. For example, the user interface may provide a visible, audible, or tactile notification to the user. When the leak determination module determines that the liquid drug has leaked out of at least one of a reservoir, a fluid line, or a cannula assembly, a notification indicating the leak of the medical infusion device is provided to the user. According to an embodiment of the present invention, the medical infusion device is part of a medical infusion device system, wherein the user interface configured to indicate the presence of a leak of a liquid drug to a user of the medical infusion device based on a determination of a leak determination module is part of a remote control. The remote control may be a dedicated remote control or a software application operating on a smartphone.

[0026] According to an embodiment of the present invention, the medical infusion device comprises a disposable part and a reusable part, wherein the disposable part comprises at least a reservoir, a fluid line, a cannula assembly and at least one electronic probe of a leakage determination module and / or at least one electronic reference probe of a leakage determination module. The disposable part is intended to be replaced by a user more frequently as its components, such as a reservoir, a fluid line and a cannula assembly. The at least one electronic probe and the at least one electronic reference probe are intended to contact the odor molecules and / or flavor molecules of a liquid drug. Therefore, it may be necessary to replace the at least one electronic probe and the at least one electronic reference probe more frequently, which can be achieved by providing them with a disposable part of a medical infusion device. Although the at least one electronic probe and / or the at least one electronic reference probe are part of the disposable part, the at least one electronic probe and the at least one electronic reference probe (if present) are still operably coupled to an evaluation electronic device, which is used to determine that the liquid drug leaks out of at least one of a reservoir, a fluid line or a cannula assembly.

[0027] According to an embodiment of the invention, the reusable portion comprises evaluation electronics.

[0028] Thus, both the at least one electronic probe and / or the at least one electronic reference probe and the evaluation electronics can be part of the disposable part or the reusable part, arranged together or separately in one of the disposable part and the reusable part. However, in any case, the at least one electronic probe and the at least one electronic reference probe (if present) are always operably coupled to the evaluation electronics.

[0029] According to an embodiment of the invention, the disposable part contains the evaluation electronics.

[0030] According to an embodiment of the present invention, the leakage determination module is reversibly separable from the medical infusion device. The leakage determination module can be reversibly coupled to the medical infusion device and decoupled from the medical infusion device. Therefore, the worn leakage determination module can be replaced with a new leakage determination module without replacing the entire medical infusion device. Similarly, in the case where the at least one electronic probe and / or the at least one electronic reference probe and / or the evaluation electronic device are separable from each other, they can be replaced individually without replacing the corresponding other probes or the evaluation electronic device.

[0031] According to an embodiment of the present invention, the evaluation electronic device is configured to suspend determining the leakage of the liquid drug from at least one of the reservoir, fluid line or cannula assembly within a predetermined time period after determining that the liquid drug has leaked out from at least one of the reservoir, fluid line or cannula assembly. The odor molecules and / or flavor molecules that reach the at least one electronic probe or the at least one electronic reference probe (if present) can occupy the area of ​​the corresponding probe that is sensitive to the odor molecules and / or flavor molecules of the liquid drug. Excessive occupation of the sensitive area can have a negative impact on the sensitivity of the corresponding electronic probe. According to an embodiment, the occupation of the sensitive area by the odor molecules and / or flavor molecules can be reduced (if applicable) by evaporation of the received odor molecules and / or flavor molecules, self-cleaning or cleaning of the corresponding electronic probe.

[0032] Furthermore, once the leakage of the liquid medicine has been determined by the leakage determination module, there is no need to continue to determine the leakage until the cause of the leakage has been removed. Continuing to determine the presence of odor molecules and / or flavor molecules may increase the wear of the corresponding probe. Pausing the determination of the leakage of the liquid medicine by the leakage determination module is beneficial to the sensitivity and wear of the corresponding probe.

[0033] According to an embodiment of the present invention, the duration of the pause may be limited by a predetermined time period that has passed or by user input, thereby resuming the determination by the leak determination module of leakage of liquid drug from at least one of the reservoir, fluid line, or cannula assembly.

[0034] In order to avoid excessive flushing of the at least one electronic probe and / or the at least one electronic reference probe (if present) by the liquid medicine, according to one embodiment, the at least one electronic probe and / or the at least one electronic reference probe (if present) comprises a gas permeable membrane, which is configured to be permeable to gaseous odor molecules and / or gaseous flavor molecules of the liquid medicine and impermeable to liquid components of the liquid medicine. For example, the gas permeable membrane covers the area of ​​the electronic probe or the electronic reference probe that is sensitive to volatile odor molecules and / or volatile flavor molecules, respectively.

[0035] According to an embodiment, the medical infusion device is a body-wearable medical infusion pump, preferably a body-wearable medical patch pump. The body-wearable medical infusion pump may include a user interface. For example, a display, a touch screen, one or more buttons, one or more switches, a speaker, one or more lights. The body-wearable medical infusion pump and the body-wearable medical patch pump may lack a graphical user interface on the pump, but may be operably coupled to a remote control including a graphical user interface. For example, the graphical user interface may be a touch screen. The remote control may be operably coupled to the body-wearable medical patch pump or the body-wearable medical infusion pump by using wireless communication means. According to one embodiment, the body-wearable medical patch pump includes a disposable part and a reusable part, wherein the reusable part includes: a microprocessor; and a communication module configured to communicate with a remote control (such as a dedicated remote control or a software application operating on a smartphone); and a single-use battery or a rechargeable battery as appropriate. The disposable part includes a reservoir, a fluid line, and a cannula assembly. A single-use battery or a rechargeable battery may be housed in one of the disposable portion and / or the reusable portion.

[0036] According to an embodiment, the liquid medicine is insulin or a medical solution containing insulin. Therefore, the at least one electronic probe and / or the at least one electronic reference probe (if present) is configured to receive odor molecules and / or flavor molecules of insulin or a medical solution containing insulin or a component thereof.

[0037] In addition, at least one of the aforementioned purposes is also solved by a medical infusion system. The medical infusion system includes a medical infusion device and a remote control. The medical infusion device includes a reservoir configured to contain a liquid drug, a cannula assembly, a fluid line in fluid communication with the reservoir and the cannula assembly, a drive mechanism, and a dispensing member that dispenses the liquid drug from the reservoir through the fluid line and the cannula assembly when actuated by the drive mechanism. The medical infusion device is operably coupled to the remote control, for example via a wireless communication channel. The medical infusion device, except for the presence of the leakage determination module, may be of the type described above.

[0038] The remote control includes a leakage determination module, which is configured to determine that the liquid drug leaks out from at least one of the reservoir, fluid pipeline or cannula assembly of the medical infusion device. The leakage determination module includes an electronic probe configured to receive the odor molecules and / or flavor molecules of the liquid drug and an evaluation electronic device configured to determine the presence of the odor and / or flavor of the liquid drug based on the reading content of the at least one electronic probe. The at least one electronic probe is a directional electronic probe, which is configured to receive the odor molecules and / or flavor molecules of the liquid drug outside the remote control. During its use, the remote control can be moved closely relative to the medical infusion device so that the directional electronic probe can receive the odor molecules and / or flavor molecules of the liquid drug in close proximity to the medical infusion device. Therefore, the user can check whether the medical infusion device leaks the liquid drug by sensing the medical infusion device or its components with the directional electronic probe of the remote control. The sensing of the medical infusion device can also help the user target the source of the leak and / or can further help confirm the appropriate state of one or more of the medical infusion device, the reservoir, the fluid pipeline or the cannula assembly. For example, a user can sense a medical infusion device or its components to identify or scan microcracks in a reservoir, fluid line, or cannula assembly. The user can be notified of the results of the determination of odor molecules and / or flavor molecules by visual, auditory, or tactile feedback provided by a remote control. Therefore, the remote control includes a user interface that is configured to provide visual, auditory, or tactile notifications to the user when a leak determination module determines the presence of a liquid drug. According to one embodiment, the remote control is configured to send a signal indicating the result of a leak determination to other devices, such as a medical infusion device of a medical infusion system. Other devices, such as a medical infusion device, can be configured to receive a corresponding signal indicating the result of a leak determination and be configured to trigger a notification to the user. For example, after receiving a signal indicating the result of a leak determination, the medical infusion device can provide auditory, visual, or tactile feedback to the user.

[0039] In this regard, as shown in the foregoing and following detailed description of embodiments and claims, reference to an electronic probe of a medical infusion device, its characteristics apply to a directional electronic probe of a remote control of a medical infusion device, and vice versa.

[0040] Further advantages, features and technical effects of the present invention will be apparent from the following description of the embodiments and the accompanying drawings.

[0041] Figure 1 A schematic diagram of a medical infusion device according to an embodiment of the present invention is shown;

[0042] Figure 2 A schematic diagram of a medical infusion device according to another embodiment of the present invention is shown;

[0043] Figure 3 A schematic diagram of a medical infusion device according to another embodiment of the present invention is shown;

[0044] Figure 4 A schematic diagram of a medical infusion device according to another embodiment of the present invention is shown;

[0045] Figure 5 A schematic diagram of a medical infusion device according to an embodiment of the present invention is shown; and

[0046] Figure 6 A schematic diagram of a medical infusion system according to an embodiment of the present invention is shown.

[0047] Figure 1 A schematic diagram of a medical infusion device according to an embodiment of the present invention is shown. The medical infusion device 1 comprises a housing 15 and a reservoir 2 therein, which is configured to contain a liquid drug, such as, for example, insulin. Thus, the reservoir 2 forms a container for the liquid drug. The medical infusion device 1 further comprises a dispensing member 6 movably arranged in the reservoir 2. When actuated by the drive mechanism 5, the dispensing member 6 advances in the reservoir 2 to dispense the liquid drug from the reservoir 2 into the fluid line 4. By way of example only, the movement of the dispensing member 6 in Figure 1 The fluid line 4 is fluidically coupled to the cannula assembly 3. Thus, when the dispensing member 6 is moved within the reservoir 2 in a first direction, the liquid drug contained in the reservoir 2 is dispensed from the reservoir 2 into the fluid line 4 and ultimately through the cannula assembly 3.

[0048] The medical infusion device 1 further comprises a microprocessor 14 operatively coupled to the drive mechanism 5. The microprocessor 14 is configured to control the operation of the drive mechanism 5.

[0049] In order to detect the leakage of liquid medicine from the reservoir 2 and / or the fluid line 4, the electronic probe 8 is arranged at the coupling between the reservoir 2 and the fluid line 4. The electronic probe 8 is located outside the reservoir 2 and the fluid line 4, close to the outer periphery of the reservoir 2 and the fluid line 4 by 5 mm or less. The electronic probe 8 is configured to receive the odor molecules and / or flavor molecules of the liquid medicine. The odor molecules and / or flavor molecules of the liquid medicine leaking from the reservoir 2 and / or the fluid line 4 will be received by the electronic probe 8, for example, in its sensitive area. After receiving the odor molecules and / or flavor molecules of the liquid medicine, the electronic probe 8 will generate an electronic signal indicating the presence of the odor molecules and / or flavor molecules of the liquid medicine. The electronic signal provided by the electronic probe 8, that is, the reading content of the electronic probe 8, is transmitted to the evaluation electronic device 9.

[0050] The evaluation electronics 9 are contained in the microprocessor 14 and are configured to determine the presence of an odor and / or flavor of the liquid medicament based on the readings of the electronic probe 8. The electronic probe 8 and the evaluation electronics together form a leakage determination module 7.

[0051] Figure 2 A schematic diagram of a medical infusion device according to a second embodiment of the present invention is shown. Figure 2 The medical infusion device 1 corresponds to Figure 1 The illustrated embodiment, except that the medical infusion device 1 includes a disposable part 1a and a reusable part 1b. The disposable part 1a includes a reservoir 2, a fluid line 4, a cannula assembly 3, a dispensing member 6 and an electronic probe 8. The reusable part 1b includes a drive mechanism 5 and a microprocessor 14, which includes an evaluation electronic device 9. The electronic probe 8 and the evaluation electronic device 9 are operably coupled to form a leak determination module 7. The readings from the electronic probe 8 are transmitted to the evaluation electronic device 9, which is used to determine the presence of an odor and / or flavor of the liquid drug. The disposable part 1a and the reusable part 1b are detachable, so that the disposable part 1a and the reusable part 1b can be replaced separately as needed. Therefore, the electronic probe 8 and the evaluation electronic device 9 are reversibly separable.

[0052] Figure 3 FIG. 2 shows a schematic diagram of another embodiment of a medical infusion device 1 according to the present invention. Figure 3 The medical infusion device 1 shown is similar to Figure 1 The embodiment shown differs in that it has three discharge channels 10 and one discharge chamber 11. Figure 1 The embodiments shown in FIG. Figure 3 The electronic probe 8 of the medical infusion device 1 of the illustrated embodiment is arranged in the discharge chamber 11. The odor molecules and / or flavor molecules of the liquid medicine leaked from at least one of the reservoir 2, the fluid line 4, or the cannula assembly 3 enter at least one of the three discharge channels 10 and are transported to the discharge chamber 11. After entering the discharge chamber 11, the odor molecules and / or flavor molecules reach the electronic probe 8, where they are received at the sensitive area of ​​the electronic probe 8.

[0053] Figure 4 FIG. 2 is a schematic diagram showing another embodiment of a medical infusion device 1 according to the present invention. Figure 3 The illustrated embodiment of the medical infusion device 1 differs in that it additionally comprises an electronic reference probe 12 and a gas-permeable membrane 13 .

[0054] The gas permeable membrane 13 is permeable to volatile odor molecules and / or flavor molecules and impermeable to liquid components of the liquid medicine.The gas permeable membrane 13 is arranged in the discharge chamber 11 and thus prevents the electronic probe 8 from being excessively blocked by the liquid components of the liquid medicine.

[0055] The electronic reference probe 12 is configured and arranged to receive odor molecules and / or flavor molecules of a liquid drug outside the medical infusion device 1. Here, the electronic reference probe 12 is located at the periphery of the housing 15 of the medical infusion device 1. The electronic reference probe 12 is operably coupled to the evaluation electronic device 9 so that the reading content of the electronic reference probe 12 is transmitted to the evaluation electronic device 9, which is used to determine the presence of the odor molecules and / or flavor molecules of the liquid drug. Determining the presence of the liquid drug based on the reading content of the electronic reference probe 12 helps prevent false positive determinations of leakage of the liquid drug.

[0056] Figure 5 Schematic diagram of a medical infusion device according to an embodiment of the present invention is shown. The medical infusion device 1 corresponds to Figure 1 The medical infusion device 1 of the embodiment of the present invention is a medical infusion device 1, but additionally includes a wireless communication module 16. The wireless communication is operably coupled to the microprocessor 14 and is configured to communicate with a remote control 17 (here: a smart phone including a touch screen 18). When the liquid drug leaking out of at least one of the reservoir 2, the fluid line 4 or the cannula assembly 3 is determined by the evaluation electronic device 9 based on the reading content of the electronic probe 8, an electrical signal indicating the determination is sent to the remote control 17 via the wireless communication module 16. The remote control 17 notifies the user by displaying a corresponding notification on the touch screen of the remote control 17.

[0057] Figure 6 A schematic diagram of a medical infusion system according to an embodiment of the present invention is shown. The medical infusion system comprises a medical infusion device 1 and a remote control 17 .

[0058] The medical infusion device 1 comprises a housing which houses a reservoir 2, a fluid line 4 and a cannula assembly 3. A dispensing member 6 is movably arranged in the reservoir 2, wherein the movement of the dispensing member 6 is induced by a drive mechanism 5. When advancing in the reservoir 2, the liquid drug contained in the reservoir 2 is dispensed from the reservoir 2 into the fluid line 4 and through the cannula assembly 3.

[0059] The medical infusion device 1 further comprises a microprocessor 14 operably coupled to the drive mechanism 5 and configured to control the operation of the drive mechanism 5. The microprocessor 14 is further operably coupled to a wireless communication module 16 for receiving signals from and transmitting signals to a remote control 17.

[0060] The remote control 17 (here, for example, a smartphone) includes a user interface (e.g., a touch screen 18), a leakage determination module including an electronic probe 8 and an evaluation electronic device 9. The electronic probe 8 is configured to receive odor molecules and / or flavor molecules of a liquid drug, wherein the evaluation electronic device 9 is configured to determine the presence of an odor and / or flavor of the liquid drug based on the reading of the electronic probe 8. The electronic probe 8 is a directional electronic probe configured to receive odor molecules and / or flavor molecules from a liquid drug outside the remote control 17. When in use, the remote control 8 can be moved relative to the medical infusion device 1 to sense the medical infusion device 1 or a component thereof with the directional electronic probe 8 of the remote control 17 to determine whether the liquid drug is leaking out of at least one of the reservoir 2, the fluid line 4, and the cannula assembly 3.

[0061] Remote control 17 is further configured to notify a user if evaluation electronic device 9 determines the presence of a leak in at least one of reservoir 2, fluid line 4, and cannula assembly 3 based on the readings of electronic probe 8. For example, remote control 17 may display a notification on touch screen 18 of remote control 17 to inform the user of the result of determining that liquid drug has leaked out of at least one of reservoir 2, fluid line 4, and cannula assembly 3.

[0062] Reference numerals list

[0063] 1Medical infusion devices

[0064] 1a Disposable parts of medical infusion sets

[0065] 1b Reusable parts of medical infusion sets

[0066] 2 Storage

[0067] 3 Cannula assembly

[0068] 4 Fluid pipelines

[0069] 5. Driving mechanism

[0070] 6. Assigning components

[0071] 7 Leak Determination Module

[0072] 8 Electron Probe

[0073] 9. Evaluating Electronic Devices

[0074] 10 Discharge channel

[0075] 11. Emission Chamber

[0076] 12 Electronic reference probe

[0077] 13 Gas Permeable Membranes

[0078] 14 Microprocessor

[0079] 15. Housing

[0080] 16 Wireless communication module

[0081] 17 Remote Control

[0082] 18 Touch screen (user interface)

Claims

1. A medical infusion device (1), comprising a reservoir (2) configured to contain a liquid drug, ●Cannula assembly (3), a fluid line (4) in fluid communication with the reservoir (2) and the cannula assembly (3), ● Driving mechanism (5), a dispensing member (6) which, when actuated by the drive mechanism (5), dispenses liquid drug from the reservoir (2) through the fluid line (4) and the cannula assembly (3), and a leakage determination module (7) configured to determine that the liquid drug has leaked from at least one of the reservoir (2), the fluid line (4) or the cannula assembly (3), Features ●The leakage determination module (7) includes an electronic probe (8) configured to receive odor molecules and / or flavor molecules of the liquid medicine, and wherein the leakage determination module (7) further includes an evaluation electronic device (9) configured to determine the presence of the odor and / or flavor of the liquid medicine based on the reading content of at least one electronic probe (8).

2. The medical infusion device (1) according to claim 1, characterized in that The at least one electronic probe (8) is located at one or more positions on the reservoir (2) or outside the reservoir, and / or at one or more positions on the cannula assembly (3) or outside the cannula assembly, and / or at one or more positions on the fluid line (4) or outside the fluid line.

3. The medical infusion device (1) according to claim 1 or 2, characterized in that: The medical infusion device (1) comprises at least one drainage channel (10) configured to direct liquid drug leaking from at least one of the reservoir (2), the fluid line (4) or the cannula assembly (3) toward the at least one electronic probe (8).

4. The medical infusion device (1) according to any one of claims 1 to 3, characterized in that: The medical infusion device (1) comprises at least one drain chamber (11) configured to collect liquid medicine leaking from at least one of the reservoir (2), the fluid line (4) or the cannula assembly (3), wherein the drain chamber (11) comprises the at least one electronic probe (8) of the leak determination module (7).

5. The medical infusion device (1) according to any one of claims 1 to 4, characterized in that: The leakage determination module (7) comprises at least one electronic reference probe (12) configured and arranged to receive odor molecules and / or flavor molecules of the liquid medicine outside the medical infusion device (1), and wherein the evaluation electronic device (9) is further configured to determine the presence of the odor and / or flavor of the liquid medicine based on the reading content of the at least one electronic reference probe (12) and the reading content of the at least one electronic probe (8).

6. The medical infusion device (1) according to any one of claims 1 to 5, characterized in that: The medical infusion device (1) comprises a user interface (13) configured to indicate the presence of a leakage of liquid drug to a user of the medical infusion device (1) based on the determination of the leakage determination module (7).

7. The medical infusion device (1) according to any one of claims 1 to 6, characterized in that The medical infusion device (1) comprises a disposable part (1a) and a reusable part (1b), wherein the disposable part (1a) comprises at least the reservoir (2), the fluid line (4), the cannula assembly (3) and the at least one electronic probe (8) of the leak determination module (7) and / or the at least one electronic reference probe (12) of the leak determination module (7).

8. The medical infusion device (1) according to claim 7, characterized in that The reusable part (1b) contains the evaluation electronics (9).

9. The medical infusion device (1) according to claim 7, characterized in that The disposable part (1a) contains the evaluation electronics (9).

10. The medical infusion device (1) according to any one of claims 1 to 9, characterized in that The leakage determination module (7) is reversibly detachable from the medical infusion device (1).

11. The medical infusion device (1) according to any one of claims 1 to 10, characterized in that The evaluation electronic device (9) is configured to suspend the determination of leakage of liquid drug from at least one of the reservoir (2), the fluid line (4) or the cannula assembly (3) for a predetermined period of time after determining that the liquid drug has leaked from at least one of the reservoir (2), the fluid line (4) or the cannula assembly (3).

12. The medical infusion device (1) according to any one of claims 1 to 11, characterized in that The at least one electronic probe (8) and / or the at least one electronic reference probe (12) comprises a gas permeable membrane (13) which is permeable to gaseous odor molecules and / or gaseous flavor molecules of the liquid medicine and impermeable to liquid components of the liquid medicine.

13. The medical infusion device (1) according to any one of claims 1 to 12, characterized in that The medical infusion device (1) is a body-wearable medical infusion pump, preferably a body-wearable medical patch pump.

14. A medical infusion system, comprising a medical infusion device and a remote control (17), wherein the medical infusion device comprises: a reservoir (2) configured to contain a liquid drug; a cannula assembly (3); a fluid line (4) in fluid communication with the reservoir (2) and the cannula assembly (3); a drive mechanism (5); and a dispensing member (6) which, when actuated by the drive mechanism (5), dispenses the liquid drug from the reservoir (2) through the fluid line (4) and the cannula assembly (3), wherein the medical infusion device is operably coupled to the remote control (17), characterized in that: The remote control (17) includes a leak determination module (7) configured to determine that the liquid drug has leaked out of at least one of the reservoir (2), the fluid line (4), or the cannula assembly (3) of the medical infusion device, wherein the leak determination module (7) includes: an electronic probe (8) configured to receive odor molecules and / or flavor molecules of the liquid drug originating from outside the remote control (17); and evaluation electronics (9) configured to determine the presence of an odor and / or flavor of the liquid medicament based on the reading of the at least one electronic probe (8).

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