Medical infusion device comprising a leakage determination module

Abstract

The present invention relates to a medical infusion device comprising a reservoir for holding a liquid medicament, a cannula assembly, a fluid line, a drive mechanism, a dispensing member for dispensing the medicament from the reservoir through the fluid line and the cannula assembly, and a leakage determination module. For more convenient determination of leakage of the liquid medicament, the leakage determination module comprises an electronic probe configured to receive odor molecules and / or flavor molecules of the liquid medicament, and the leakage determination module further comprises an evaluation electronic device configured to determine the presence of the odor and / or flavor of the liquid medicament based on a reading value of at least one electronic probe.

Description

Technical Field

[0001] The present invention relates to a medical infusion device comprising a reservoir configured to hold a liquid medicament, 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 medicament 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 medicament from at least one of the reservoir, the fluid line or the cannula assembly.

Background Art

[0002] Medical infusion devices are used to provide a user of the infusion device with a liquid medicament aimed at improving the health condition of a patient. Thus, the liquid medicament contained in the reservoir of the medical infusion device is dispensed through the fluid line and the cannula assembly by a dispensing member actuated by a drive mechanism. However, malfunctions may occur that result in unintentional leakage of the liquid medicament from one or more of the reservoir, the fluid line or the cannula assembly. For example, leakage can be caused by mechanical shock to the medical infusion device, particularly to the liquid medicament containing or guiding components, or by improper assembly of the medical infusion device.

[0003] Leakage may, as a result, not provide the user of the medical infusion device with the desired amount of liquid medicament. In many cases, particularly small amounts of liquid medicament leakage may go unnoticed by the user. This can even result in underdosing or overdosing of the liquid medicament. The latter can occur when the desired effect of the liquid medicament is lost and the medical infusion device is operated to compensate for the leakage of the liquid medicament, but the amount of the underdosed liquid medicament actually provided is unknown to the user or unknown to the semi-automatic / full-automatic delivery algorithm of the medical infusion pump if the medical infusion pump is operated with such an algorithm.

[0004] Accordingly, known medical infusion devices heretofore include a leak detection module configured to detect leakage of a liquid drug from at least one of a reservoir, a fluid line, or a cannula assembly. However, these leak detection modules of known medical infusion pumps heretofore are indicator papers or humidity sensors. The use of indicator papers is cumbersome for the user of a medical infusion pump because the indication of leakage becomes apparent only by frequently looking at the indicator paper. Also, the indicator paper is not specific to the type of liquid that wets the indicator paper. Accordingly, depending on the user's environment, the indicator paper may erroneously indicate leakage of the liquid drug due to ingress of water or humidity. This also applies when a humidity sensor is used instead of the indicator paper. SUMMARY OF THE INVENTION

[0005] Accordingly, an object of the present invention is to provide a medical infusion device that avoids at least one of the problems associated with medical devices known from the prior art. In particular, an object of the present invention is to provide a medical infusion device that enables a more convenient detection 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 hold 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 is actuated by the drive mechanism to dispense the liquid drug from the reservoir through the fluid line and the cannula assembly, 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. The leakage determination module includes an electronic probe configured to receive odor molecules and / or flavor molecules of the liquid drug, and the leakage determination module further includes an evaluation electronic device configured to determine the presence of the odor and / or flavor of the liquid drug based on a reading value of at least one electronic probe.

[0008] In use, the liquid drug is contained in the reservoir of the medical infusion device, and 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 through the cannula assembly. Leakage of the liquid drug is any unintended flow of the liquid drug from one of the reservoir, the fluid line, or the cannula assembly. The cannula assembly can include a septum and a connecting needle that pierces the septum during use to provide fluid communication through a connecting line from the reservoir through the septum and into the cannula via the fluid line.

[0009] Leakage of the liquid drug from at least one of the reservoir, the fluid line, and the cannula assembly is determined by the 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 odor molecules and / or flavor molecules of the liquid drug. That is, the odor molecules and / or flavor molecules of the liquid drug leaking from at least one of the reservoir, the fluid line, or the cannula assembly are received by the electronic probe, and when 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 value of the electronic probe, is received by the evaluation electronic device of the leakage determination module. The evaluation electronic device determines the presence of odor molecules and / or flavor molecules based on the reading value of the electronic probe. The electronic probe and the evaluation electronic device together form an electronic detection device configured to detect the odor and / or flavor of the liquid medicine.

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

[0012] In the context of the present invention, the metal oxide semiconductor is a transistor that amplifies or switches an electronic signal. The odor molecules and / or flavor molecules received by the probe are charged either positively or negatively, thereby changing the electric field inside the MOSFET. The odor molecules and / or flavor molecules change the MOSFET signal that can be interpreted by the evaluation electronic device.

[0013] In the context of the present invention, the conductive polymer is an organic polymer that conducts electricity. When it receives odor molecules and / or flavor molecules, the conductivity of the polymer changes respectively, thereby generating a sensor signal that can be interpreted by the evaluation electronic device.

[0014] Similarly, in the context of the present invention, a non-conductive polymer added with a conductive material such as carbon black also changes its conductivity when it receives odor molecules and / or flavor molecules. The change in conductivity results in a change in the sensor signal that can be interpreted by the evaluation electronic device.

[0015] In the context of the present invention, a quartz crystal microbalance measures the mass variation per unit area by measuring the change in the frequency of a quartz crystal. When receiving odor molecules and / or flavor molecules, the mass per unit area changes, and the frequency of the quartz crystal changes. The change in frequency generates a sensor signal that can be interpreted by an evaluation electronic device.

[0016] Furthermore, in the context of the present invention, a surface acoustic wave is a microelectromechanical system that relies on the modulation of surface acoustic waves to sense the deposition of odor molecules and / or flavor molecules. For example, an elastic wave travels along the surface of an elastic material with an amplitude that exponentially decays with depth into the material. When receiving odor molecules and / or flavor molecules, the physical properties of the microelectromechanical system change, which affects the surface acoustic wave. Therefore, the sensor signal generated based on the change in the surface acoustic wave can be interpreted by an evaluation electronic device to determine the presence of odor molecules and / or flavor molecules.

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

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

[0019] According to one embodiment of the present invention, a medical infusion device includes at least one discharge channel configured to guide a liquid drug leaking from at least one of a reservoir, a fluid line, or a cannula assembly toward at least one electronic probe of a leakage determination module. The at least one discharge channel guides a liquid drug leaking from at least one of the reservoir, the fluid line, or the cannula assembly toward at least one probe. Thereby, the at least one probe can be disposed at any position within the medical infusion device. In particular, the at least one probe can be disposed at a position remote from the reservoir, the fluid line, or the cannula assembly. The at least one probe can be located at a position prone to leakage, such as a transition between the reservoir and the fluid line, a transition between the fluid line and the cannula assembly, the inlet of the reservoir if present, or a position different from the outlet of the reservoir. Further, the medical infusion device can include a plurality of discharge channels each configured to guide a liquid drug leaking from at least one of the reservoir, the fluid line, or the cannula assembly toward at least one probe. Thereby, at least one probe can be used to detect a liquid drug that may leak from different positions of at least one of the reservoir, the fluid line, or the cannula assembly.

[0020] According to one embodiment of the present invention, a medical infusion device comprises at least one discharge chamber configured to collect a liquid drug leaking from at least one of a reservoir, a fluid line or a cannula assembly, the discharge chamber comprising at least one electronic probe of a leak detection module. According to yet another embodiment, the at least one discharge chamber is in fluid communication with at least one discharge channel. The liquid drug collected within the discharge chamber is guided through the discharge channel from the discharge chamber towards the electronic probe, or the at least one discharge channel guides the liquid drug leaking from at least one of the reservoir, the fluid line, or the cannula assembly into the at least one discharge chamber, and the discharge chamber comprises at least one electronic probe of a leak detection module. Thus, instead of placing at least one electronic probe at or near a location prone to leakage, the at least one probe is placed at a location within a guiding system comprising at least one discharge channel and / or at least one discharge chamber. This enables a more flexible configuration of the medical infusion device, which is particularly beneficial with respect to the desired form factor to be obtained by the medical infusion device.

[0021] According to one embodiment of the present invention, the at least one electronic probe is located at one or more positions on or outside the medical infusion device, and the at least one electronic probe is configured to receive odor and / or flavor molecules outside the medical infusion device. By way of example only, the at least one electronic probe may be incorporated within or located on the housing of the medical infusion device. The liquid drug leaking from at least one of the reservoir, the fluid line or the cannula assembly may flow out of the medical infusion device along the perimeter of the medical infusion device in some form, or accumulate outside the medical infusion device during use of the medical infusion device. For example, between or in the vicinity of the medical infusion device and the patient's body.

[0022] According to one embodiment of the present invention, the leakage determination module includes at least one electronic reference probe configured and arranged to receive odor molecules and / or flavor molecules of the liquid drug outside the medical infusion device, and the evaluation electronic device is further configured to determine the presence of the odor and / or flavor of the liquid drug based on the reading value of at least one electronic reference probe and the reading value of at least one electronic probe. During the use of the medical infusion device, for example, due to previous leakage, mishandling or contamination, even if there is no leakage in at least one of the reservoir, fluid line or cannula assembly, the liquid drug may be present outside the medical infusion device. The reference probe provides a reading value of odor molecules and / or flavor molecules of the liquid drug that may be present outside the medical infusion device. The evaluation electronic device determines whether the liquid drug leaks from at least one of the reservoir, fluid line, or cannula assembly based on the reading values of the electronic probe and the electronic reference probe. For example, if the reading value of the electronic probe indicates the presence of odor molecules and / or flavor molecules of the liquid drug, but the reading value of the electronic reference probe does not indicate the presence of odor molecules and / or flavor molecules, the evaluation electronic device determines that there is a leakage of the liquid drug from at least one of the reservoir, fluid line, or cannula assembly. Further, for example, if the reading values of both the at least one electronic probe and the at least one electronic reference probe indicate the presence of odor molecules and / or flavor molecules, the evaluation electronic device determines that there is no leakage of the liquid drug from at least one of the reservoir, fluid line or cannula assembly. Similarly, for example, if only the reading value of the at least one electronic reference probe indicates the presence of odor molecules and / or flavor molecules of the liquid drug, the evaluation electronic device determines that there is no leakage of the liquid drug from at least one of the reservoir, fluid line or cannula assembly.

[0023] At least one electronic probe is intended to indicate the presence of odor molecules and / or flavor molecules to confirm leakage, while at least one electronic reference probe is intended to indicate the absence of odor molecules and / or flavor molecules to prevent false positive conclusions.

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

[0025] According to one embodiment of the present invention, the medical infusion device comprises a user interface configured to indicate the presence of a leak of the liquid drug to the user of the medical infusion device based on the determination of the leak determination module. For example, the user interface may provide a visual, audible, or tactile notification to the user. A notification indicating a leak of the medical infusion device is provided to the user when the leak determination module determines a leak of the liquid drug from at least one of the reservoir, the fluid line, or the cannula assembly. According to one embodiment of the present invention, the medical infusion device is part of a medical infusion device system, and the user interface configured to indicate the presence of a leak of the liquid drug to the user of the medical infusion device based on the determination of the leak determination module is part of a remote control device. The remote control device can be a dedicated remote control device or can be a software application operating on a smartphone.

[0026] According to one embodiment of the present invention, a medical infusion device comprises a disposable part and a reusable part. The disposable part comprises at least a reservoir, a fluid line, a cannula assembly, and at least one electronic probe of a leak detection module and / or at least one electronic reference probe of the leak detection module. The disposable part is intended to be frequently replaced by the user as its components such as the reservoir, the fluid line, and the cannula assembly. The at least one electronic probe and the at least one electronic reference probe are intended to come into contact with odor molecules and / or flavor molecules of the 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 in the disposable part of the medical infusion device. Nevertheless, the at least one electronic probe and / or the at least one electronic reference probe are part of the disposable part, and 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 to determine leakage of the liquid drug from at least one of the reservoir, the fluid line, or the cannula assembly.

[0027] According to one embodiment of the present invention, the reusable part comprises an evaluation electronic device.

[0028] As a result, both the at least one electronic probe and / or the at least one electronic reference probe and the evaluation electronic device can be part of the disposable part or the reusable part, and can be 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 electronic device.

[0029] According to one embodiment of the present invention, the disposable part comprises an evaluation electronic device.

[0030] According to one embodiment of the present invention, the leakage determination module is reversibly separable from the medical infusion device. The reversibly separable leakage determination module can be operably coupled to the medical infusion device and separated from the medical infusion device. Thereby, the worn leakage determination module can be replaced with a new leakage determination module without the need to replace the entire medical infusion device. Similarly, if at least one electronic probe and / or at least one electronic reference probe and / or evaluation electronics are separable from each other, they can be individually replaced without the need to replace each other's other probes or evaluation electronics.

[0031] According to one embodiment of the present invention, the evaluation electronics are configured to suspend the determination of leakage of the liquid drug from at least one of the reservoir, fluid line, or cannula assembly for a predetermined period following the determination of leakage of the liquid drug from at least one of the reservoir, fluid line, or cannula assembly. Odor molecules and / or flavor molecules reaching at least one electronic probe or at least one electronic reference probe, if present, can occupy the region of the respective probe that senses the odor molecules and / or flavor molecules of the liquid drug. Excessive occupancy of the sensing region adversely affects the sensitivity of the respective electronic probe. According to one embodiment, occupancy of the sensing region by 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 respective electronic probe.

[0032] Furthermore, when the leakage of the liquid drug is determined by the leakage determination module, there is no need to continuously determine the leakage until the cause of the leakage is removed. Continuously determining the presence of odor molecules and / or flavor molecules can increase the wear of the respective probe. Suspending the determination of leakage of the liquid drug by the leakage determination module is beneficial with respect to the sensitivity and wear of the respective probe.

[0033] According to one embodiment of the present invention, the duration of the pause can be limited by the elapse of a predetermined time or by a user input that resumes the determination of the leakage of the liquid drug from one of the reservoir, the fluid line, or the cannula assembly by the leakage determination module.

[0034] According to one embodiment, to avoid excessive flushing of at least one electronic probe and / or at least one electronic reference probe by the liquid drug, if present, the at least one electronic probe and / or the at least one electronic reference probe, if present, comprises a gas permeable membrane configured to permeate gaseous odor molecules and / or gaseous flavor molecules of the liquid drug and not permeate the liquid component of the liquid drug. For example, the gas permeable membrane covers the regions of the electronic probe or the electronic reference probe that sense the volatile odor molecules and / or the volatile flavor molecules, respectively.

[0035] According to one embodiment, the medical infusion device is a body-worn medical infusion pump, preferably a body-worn medical patch pump. The body-worn medical infusion pump can 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-worn medical infusion pump and the body-worn medical patch pump can lack a graphical user interface on the pump, but can be operably coupled to a remote control device having a graphical user interface. For example, the graphical user interface can be a touch screen. The remote control device can be operably coupled to the body-worn medical patch pump or the body-worn medical infusion pump by using wireless communication means. According to one embodiment, the body-worn medical patch pump includes a disposable portion and a reusable portion. The reusable portion includes a microprocessor, a communication module configured to communicate with a remote control device such as a dedicated remote control device or a software application operating on a smartphone, and optionally a disposable battery or a rechargeable battery. The disposable portion includes a reservoir, a fluid line, and a cannula assembly. A single-use or rechargeable battery can be housed in one of the disposable portion and / or the reusable portion.

[0036] According to one embodiment, the liquid drug is insulin or a medical solution containing insulin. Thus, at least one electronic probe and / or 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 its components.

[0037] Furthermore, at least one of the aforementioned objects is also solved by a medical infusion system. The medical infusion system includes a medical infusion device and a remote control device. The medical infusion device includes a reservoir configured to hold 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 device, for example, via a wireless communication channel. The medical infusion device can be of the aforementioned type except for the presence of a leakage determination module.

[0038] The remote control device includes a leakage determination module configured to determine leakage of a liquid drug from at least one of a reservoir, a fluid line, or a cannula assembly of a medical infusion device. The leakage determination module includes an electronic probe configured to receive 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 value of at least one electronic probe. At least one electronic probe is a directional electronic probe configured to receive odor molecules and / or flavor molecules of the liquid drug generated from outside the remote control device. During its use, the remote control device can be moved close to the medical infusion device so that the directional electronic probe can receive odor molecules and / or flavor molecules of the liquid drug close to the medical infusion device. Thereby, the user can check the medical infusion device for leakage of the liquid drug by sensing the medical infusion device or its components with the directional electronic probe of the remote control device. Sensing the medical infusion device can also help the user target the cause of the leak and / or further help confirm the proper condition of one or more of the medical infusion device, reservoir, fluid line, or cannula assembly. For example, the user can sense the medical infusion device or its components to identify or scan for microcracks in the reservoir, fluid line, or cannula assembly. The result of the determination of the odor molecules and / or flavor molecules can be notified to the user by visual, auditory, or tactile feedback provided by the remote control device. Accordingly, the remote control device includes a user interface configured to provide a visual, auditory, or tactile notification to the user when the leakage determination module determines the presence of the liquid drug. According to one embodiment, the remote control device is configured to transmit a signal indicating the result of the leakage determination to a further device, such as a medical infusion device of a medical infusion system. A further device, such as a medical infusion device, can be configured to receive a corresponding signal indicating the result of the leakage determination and trigger a notification to the user. For example, upon receiving a signal indicating the result of the leakage determination, the medical infusion device may provide auditory, visual, or tactile feedback to the user.

[0039] As described in the following detailed description of the above embodiments and claims, the electronic probe of the medical infusion device is referred to, and its characteristics are applicable to the directional electronic probe of the remote control device of the 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.

Brief Description of the Drawings

[0041]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Modes for Carrying Out the Invention

[0042] Figure 1 shows a schematic view of a medical infusion device according to an embodiment of the present invention. The medical infusion device 1 includes a housing 15 and, within the housing, a reservoir 2 configured to hold a liquid drug such as insulin. Thus, the reservoir 2 forms a container for the liquid drug. The medical infusion device 1 further includes a dispensing member 6 movably disposed within the reservoir 2. When actuated by a drive mechanism 5, the dispensing member 6 is advanced within the reservoir 2 to dispense the liquid drug from the reservoir 2 into the fluid line 4. The movement of the dispensing member 6 is shown by a dashed line in Figure 1 as an example only. The fluid line 4 is fluidly coupled to a cannula assembly 3. Thus, when the dispensing member 6 is moved in a first direction within the reservoir 2, the liquid drug contained in the reservoir 2 is dispensed from the reservoir 2 into the fluid line 4 and ultimately dispensed through the cannula assembly 3.

[0043] The medical infusion device 1 further includes a microprocessor 14 operably coupled to the drive mechanism 5. The microprocessor 14 is configured to control the operation of the drive mechanism 5.

[0044] To detect leakage of the liquid drug from the reservoir 2 and / or the fluid line 4, an electronic probe 8 is disposed at the junction between the reservoir 2 and the fluid line 4. The position of the electronic probe 8 is outside the reservoir 2 and the fluid line 4 and is in proximity to the outer periphery of the reservoir 2 and the fluid line 4 within 5 mm. The electronic probe 8 is configured to receive odor molecules and / or flavor molecules of the liquid drug. The odor molecules and / or flavor molecules of the liquid drug leaking from the reservoir 2 and / or the fluid line 4 are received by the electronic probe 8, for example, in the sensing region of the electronic probe. When the electronic probe 8 receives the odor molecules and / or flavor molecules of the liquid drug, it generates an electronic signal indicating the presence of the odor molecules and / or flavor molecules of the liquid drug. The electronic signal provided by the electronic probe 8, i.e., the reading value of the electronic probe 8, is transmitted to an evaluation electronic device 9.

[0045] The evaluation electronic device 9 is included in the microprocessor 14 and is configured to determine the presence of the smell and / or flavor of the liquid medicine based on the reading value of the electronic probe 8. The electronic probe 8 and the evaluation electronic device together form a leakage determination module 7.

[0046] Figure 2 shows a schematic diagram of a medical infusion device according to a second embodiment of the present invention. The medical infusion device 1 in Figure 2 corresponds to the embodiment shown in Figure 1, 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 including an evaluation electronic device 9. The electronic probe 8 and the evaluation electronic device 9 are operably coupled to form a leakage determination module 7. The reading value from the electronic probe 8 is transmitted to the evaluation electronic device 9 to determine the presence of the smell and / or flavor of the liquid medicine. The disposable part 1a and the reusable part 1b are separable 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.

[0047] Figure 3 shows a schematic diagram of another embodiment of the medical infusion device 1 according to the present invention. The medical infusion device 1 shown in Figure 3 is different from the embodiment shown in Figure 1 by having three discharge channels 10 and one discharge chamber 11. In contrast to the embodiment shown in Figure 1, the electronic probe 8 of the medical infusion device 1 in the embodiment shown in Figure 3 is disposed within the discharge chamber 11. The smell molecules and / or flavor molecules of the liquid medicine leaking 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 conveyed into the discharge chamber 11. After entering the discharge chamber 11, the smell molecules and / or flavor molecules reach the electronic probe 8 and are received from the sensing region of the electronic probe 8 there.

[0048] Figure 4 shows a schematic view of another embodiment of the medical infusion device 1 according to the present invention. The medical infusion device 1 is different from the embodiment of the medical infusion device 1 shown in Figure 3 by further including an electronic reference probe 12 and a gas permeable membrane 13.

[0049] The gas permeable membrane 13 allows volatile odor molecules and / or flavor molecules to pass through, but does not allow the liquid components of the liquid drug to pass through. The gas permeable membrane 13 is disposed within the discharge chamber 11, thus preventing excessive blockage of the electronic probe 8 by the liquid components of the liquid drug.

[0050] The electronic reference probe 12 is configured and arranged to receive odor molecules and / or flavor molecules of the liquid drug outside the medical infusion device 1. Here, the electronic reference probe 12 is located around the housing 15 of the medical infusion device 1. The electronic reference probe 12 is operably coupled to an evaluation electronic device 9 such that the reading value of the electronic reference probe 12 is transmitted to the evaluation electronic device 9 for determining the presence of odor molecules and / or flavor molecules of the liquid drug. The determination of the presence of the liquid drug based on the reading value of the electronic reference probe 12 helps to prevent false positive determinations of leakage of the liquid drug.

[0051] Figure 5 shows a schematic view of a medical infusion device according to an embodiment of the present invention. The medical infusion device 1 corresponds to the medical infusion device 1 of the embodiment according to Figure 1, but further 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 device 17, here a smartphone equipped with a touch screen 18. When it is determined by the evaluation electronic device 9 based on the reading value of the electronic probe 8 that liquid drug is leaking from at least one of the reservoir 2, the fluid line 4, or the cannula assembly 3, an electrical signal indicating the determination is transmitted to the remote control device 17 via the wireless communication module 16. The remote control device 17 notifies the user by displaying respective notifications on the touch panel of the remote control device 17.

[0052] FIG. 6 shows a schematic diagram of a medical infusion system according to an embodiment of the present invention. The medical infusion system includes a medical infusion device 1 and a remote control device 17.

[0053] The medical infusion device 1 includes a housing that houses a reservoir 2, a fluid line 4, and a cannula assembly 3. A dispensing member 6 is movably disposed within the reservoir 2, and the movement of the dispensing member 6 is induced by a drive mechanism 5. As it advances within the reservoir 2, the liquid drug contained in the reservoir 2 is dispensed from the reservoir 2 through the cannula assembly 3 into the fluid line 4.

[0054] The medical infusion device 1 further includes a microprocessor 14 that is 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 transmitting and receiving signals to and from the remote control device 17.

[0055] The remote control device 17, here for example a smartphone, includes a user interface, for example 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 the liquid drug, and the evaluation electronic device 9 is configured to determine the presence of the odor and / or flavor of the liquid drug based on the reading value of the electronic probe 8. The electronic probe 8 is a directional electronic probe configured to receive odor molecules and / or flavor molecules of the liquid drug generated from outside the remote control device 17. When in use, the remote control device 8 can be moved relative to the medical infusion device 1 to sense the medical infusion device 1 or its components using the directional electronic probe 8 of the remote control device 17 to determine whether a liquid drug is leaking from at least one of the reservoir 2, the fluid line 4, and the cannula assembly 3.

[0056] When the evaluation electronic device 9 determines the presence of a leak in at least one of the reservoir 2, the fluid line 4, and the cannula assembly 3 based on the reading value of the electronic probe 8, the remote control device 17 is further configured to notify the user. For example, the remote control device 17 can display a notification on the touch screen 18 of the remote control device 17 to inform the user about the result of the determination of the leakage of the liquid medicine from at least one of the reservoir 2, the fluid line 4, and the cannula assembly 3.

Explanation of Signs

[0057] 1 Medical infusion device 1a Disposable part of the medical infusion device 1b Reusable part of the medical infusion device 2 Reservoir 3 Cannula assembly 4 Fluid line 5 Driving mechanism 6 Dispensing member 7 Leakage determination module 8 Electronic probe 9 Evaluation electronic device 10 Discharge channel 11 Discharge chamber 12 Electronic reference probe 13 Gas permeable membrane 14 Microprocessor 15 Housing 16 Wireless communication module 17 Remote control device 18 Touch screen (user interface)

Claims

1. A reservoir (2) configured to hold a liquid medicament, a cannula assembly (3), a fluid line (4) in fluid communication with the reservoir (2) and the cannula assembly (3), a drive mechanism (5), a dispensing member (6) that dispenses the liquid medicament from the reservoir (2) through the fluid line (4) and the cannula assembly (3) when actuated by the drive mechanism (5), a leak detection module (7) configured to determine leakage of the liquid medicament from at least one of the reservoir (2), the fluid line (4), or the cannula assembly (3), a medical infusion device (1) comprising: The leak detection module (7) comprises an electronic probe (8) configured to receive odor molecules and / or flavor molecules of the liquid medicament, and the leak detection module (7) further comprises an evaluation electronic device (9) configured to determine the presence of the odor and / or flavor of the liquid medicament based on a reading value of the at least one electronic probe (8). The medical infusion device (1) is characterized in that.

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

3. The medical infusion device (1) according to claim 1 or 2, characterized in that it comprises at least one discharge channel (10) configured to guide the liquid medicament leaking from at least one of the reservoir (2), the fluid line (4), or the cannula assembly (3) towards the at least one electronic probe (8).

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

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

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

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

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

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

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 separable from the medical infusion device (1).

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

12. The at least one electronic probe (8) and / or the at least one electronic reference probe (12) comprises a gas permeable membrane (13) that permits permeation of gaseous odor molecules and / or gaseous flavor molecules of the liquid drug and does not permit permeation of the liquid component of the liquid drug. The medical infusion device (1) according to any one of claims 1 to 11.

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-worn medical infusion pump, preferably a body-worn medical patch pump.

14. A medical infusion system comprising a medical infusion device and a remote control device (17), the medical infusion device comprising a reservoir (2) configured to hold 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) that dispenses the liquid drug from the reservoir (2) through the fluid line (4) and the cannula assembly (3) when actuated by the drive mechanism (5), the medical infusion device being operatively coupled to the remote control device (17). The remote control device (17) is provided with a leakage determination module (7) configured to determine leakage of the liquid medicine from at least one of the reservoir (2), the fluid line (4), or the cannula assembly (3) of the medical infusion device. The leakage determination module (7) includes an electronic probe (8) configured to receive odor molecules and / or flavor molecules of the liquid medicine emitted from outside the remote control device (17), and an evaluation electronic device (9) configured to determine the presence of the odor and / or flavor of the liquid medicine based on a reading value of the at least one electronic probe (8). A medical infusion system characterized by comprising the above components.

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