Device for targeted, controllable and adjustable output of active substance or transportable substance by means of gas-generating unit

Abstract

The aim of the invention is to dispense, in a targeted, controlled, regulated and monitored manner, a deliverable medium, for example, into an organism (human, animal, plant) or to a technical system by means of the delivery principle of displacement with the gas generated by the gas generating unit, wherein the medium can be gaseous, liquid, viscous, pasty or powdered. As a deliverable medium, a drug or active substance in liquid, dissolved or viscous form can be envisaged, but each auxiliary substance and liquid, which can be delivered by means of the system, as well as a lubricant or protective agent (grease, oil) or reagent can also be envisaged. The system can be produced inexpensively and is suitable for economical mass production, and in addition, consumables and vulnerable parts should be easily replaced. The operation and correct adjustment of the device and the start, pause or stop of the output process should be simple, understandable and designed in such a way that the possibility of errors is minimized and the safety of the patient is maximized or the reliable operation of the technical system is ensured. This task is solved by a system described below, as disclosed in separate patent claims (1) and the following patent claims (2) to (4). The system consists essentially of the following components: a) an operation-, control-, regulation-, monitoring-and communication unit (A); b) a gas drive unit (B); c) an active substance container (C); and d) a connection system (D).

Description

Technical Field

[0001] The invention relates to a device for the targeted, controllable and adjustable delivery of an active substance or a deliverable substance by means of a delivery pressure built up by one or more gas generating units. Background Art

[0002] A large number of devices are known on the market for delivering small quantities of liquid or viscous substances according to a predetermined, constant or variable output per unit time that is to be precisely adhered to, in order to deliver active substances or deliverable substances to the human, animal or biological organism, primarily for improving, changing or maintaining its health state and / or for influencing the body's own processes.

[0003] Devices available on the market for delivering active substances or other deliverable materials in human or veterinary medicine function electromechanically with the aid of spring prestressing or on the basis of elastomers. Hose pumps are also known. Electromechanical systems are distinguished by precisely controllable dosages, but these systems are relatively large in comparison to the delivered quantities. Spring-driven systems and elastomer pumps are imprecise and not sufficiently reliable due to their design and the lack of electronics. Summary of the invention

[0004] The gas generating cell technology that is the basis for the present invention has not been used so far for metering systems in the medical field in order to produce a market-ready product that fills the gap between precise, relatively large and expensive electromechanical systems and simple, rather inaccurate and relatively cheap spring or elastomer pumps. However, the required reliability and precision could not be achieved with the previously available options for gas generating cell technology.

[0005] The object of the present invention is therefore to describe a device for the targeted, controllable and adjustable output of an active substance or a deliverable substance by means of a delivery pressure generated by a gas generation unit, which device is distinguished by its compact structural dimensions, its relatively easy-to-control delivery technology and the delivery accuracy and monitorable output that can be achieved thereby.

[0006] In general, technological progress in the field of electronics over the past few decades and the level of knowledge gained today as a result of many years of experience with gas generating units have contributed to the solution of this task, as it is now possible to combine the advantages of the small structural dimensions of the gas generating unit drive with corresponding intelligent electronics in order to construct a very small, reliable, controllable, adjustable, monitorable and safe metering system which achieves the necessary metering accuracy which is significantly improved compared to spring pumps and elastomer pumps.

[0007] The advantages over existing systems are smaller overall dimensions, simpler construction, increased mobility and independence, less complexity, improved precision, electronic adjustability, function monitoring, digital communication and simpler filling of the system. Compared to gravity-driven injection systems, the system is distinguished by a posture-independent operating principle that is independent of the existing gravity and also functions in a weightless state.

[0008] The object of the invention is to deliver a deliverable medium (which can be gaseous, liquid, viscous or powdery) in a targeted, controlled, regulated and monitored manner, for example, into an organism (human, animal, plant) or into a technical system, such as a machine or an apparatus, by means of a delivery principle that displaces gas generated by one or more gas generating units. As deliverable media, drugs or active substances in liquid, dissolved or viscous form can be envisaged when used in the technical field, as well as any auxiliary substances and liquids that can be delivered by the system, as well as lubricants (grease, oil) or reagents. The system should be able to be manufactured cost-effectively and suitable for economical mass production, and in addition, consumable and wearing parts should be easily replaceable. The operation and correct adjustment of the device and the start, pause or stop of the delivery process should be simple, understandable and designed in such a way that the possibility of errors is minimized and the safety of the patient is maximized or reliable and safe operation of the technical system is ensured.

[0009] This object is achieved by the system described below, as disclosed in independent patent claim 1 and in the following patent claims 2 to 4.

[0010] The system is based on Figure 1 It is mainly composed of the following components:

[0011] a) operating, control, regulation, monitoring and communication unit (A);

[0012] b) Gas drive unit (B);

[0013] c) a container (C) for the active substance and the deliverable substance; and

[0014] d) Connection system (D).

[0015] A) Operating units (operating, control, regulation, monitoring and communication units)

[0016] The operating unit consists of a housing, a display (such as an LCD), operating elements (such as a keyboard), an energy source (such as a button battery or a storage battery), components for wireless communication, and electronic components that perform the functions described below.

[0017] Among the most important features are one or more of the following:

[0018] a) Start function for optimal start

[0019] b) indirect control of the output variable by means of temperature, pressure and current measurements over time; and

[0020] c) Bolus function for responding to higher, short-term required doses.

[0021] The last function can be realized by a controlled discharge current or by a defined gas pressure accumulator with a trigger valve. The time required until the next pressure buildup can be used to prevent too frequent bolus delivery in a natural way.

[0022] The device can be easily adjusted (discharge rate ml / h, total amount ml, etc.) and started via the operating elements and with the aid of the display.

[0023] The operating unit has electronics that enable wireless communication, for example with a PC, tablet or smartphone. This allows all necessary values ​​to be set precisely and, if necessary, time courses to be programmed. In addition, this allows the device to be started and stopped or paused contactlessly. Reliable monitoring of outputs and networking of patients is also possible, for example using blockchain technology.

[0024] The system can also be expanded by means of a device for troubleshooting, which can, for example, eliminate a blockage by means of a pressure pulse. Such a pressure pulse can be realized by means of correspondingly switched valves, pistons and springs or detectors.

[0025] Constant active substance metering can be achieved by intelligent regulation of the gas generating unit by means of pressure and temperature measurements based on corresponding regulation algorithms and corresponding actuation of the gas generating unit.

[0026] The regulation of the delivery volume / active substance metering is carried out indirectly via pressure and temperature measurement. The general gas equation applies here: f(p,T,V)=constant. The gas production in mAh or the discharge current is integrated "standardized" (normal pressure @ 20°C). The gas production of the gas generation unit is known and can be monitored. As an alternative to this regulation method via pressure / temperature, a combination with a separate filling level measuring system, such as, for example, piston position measurement or flow measurement of the output volume, is also conceivable.

[0027] The gas diffusion of the active substance to be delivered through the housing / bag is taken into account in the calculation by the diffusion function (ml) Vd=f(p,T,V,t). The current gas quantity or active substance (drug) quantity can thus be deduced at any time by pressure and temperature calculations.

[0028] After activating the dispenser function (applet, button, etc.), the control electronics and firmware can assume that a new, completely filled active substance container is in the device. All counters / integrators can be set to "zero", ie, 100% filling.

[0029] The size of the active substance container can be identified automatically (HW coding on the container) or determined via the Uo voltage of the corresponding gas generation unit group. The charge state of the unit can be monitored simultaneously during startup via voltage monitoring.

[0030]

[0031] Quick start and learning phase

[0032] Figure 2 The first start-up of the active substance meter is sketched, wherein the gas generating unit is rapidly discharged until a "single cell voltage" (preconditioning: Konditionieren) of less than 0.4 V is reached. The gas generating unit only starts the hydrogen generation process from this voltage point. The rapid discharge of the gas generating unit now continues until a pressure of 0.15 bar is reached, where, for example, the piston friction of the delivery piston is overcome. In the starting position, the pressure increase (slope) can be monitored, whereby dead volume compensation can also be performed.

[0033] The pressure is increased until pressure equilibrium occurs ("dosing of active substance"). This pressure is recorded as "system pressure" and used as a monitoring basis in further evaluations. If the device subsequently enters one or more fault states, the learning cycle can be triggered again. In addition, it is also possible to monitor whether the maximum system pressure (final pressure) has been exceeded during the startup phase and thus normal function is impossible from the outset.

[0034] Fault condition "jamming"

[0035] If, despite continued gas generation, no pressure equalization occurs (e.g. Figure 3 ) or if a maximum theoretical pressure is exceeded, the regulating mechanism can be trained to assume that the system is blocked and therefore send a fault message or signal this fault on the device itself.

[0036] Fault condition "leakage"

[0037] If the pressure does not increase despite the gas generation or even returns to normal Figure 4 If the value shown in approaches zero, the control device can be designed so that it assumes the existence of a leak. As already mentioned above, the active substance feeder notifies such a fault and / or issues a fault message.

[0038] Pulse operation

[0039] Figure 5 A situation is shown in which the gas generating unit is controlled in "pulse operation" (approximately 1 ml in 22 minutes). A discharge at 180 ohms generates a gas rate of 2.7 ml / h. The pressure measurement signal should rise and fall again when the active substance flows. In this way, the piston movement can be determined. The stick-slip effect (adhesion friction / sliding friction) of the piston can be determined by the pressure measurement as a further indicator or measurement function of the piston movement.

[0040] Pulsed operation with a constant minimum gas rate

[0041] It is also possible to operate the gas generating unit with a "constant minimum" gas rate and superimpose "pulses", as in Figure 6 This results in a constant gas production, since this presupposes a much shorter "start-up phase" of the gas generating unit.

[0042] Compensation for gas diffusion

[0043] The diffusion of gas through the syringe housing or the outer bag can also be continuously compensated by the control mechanism by achieving an increased gas velocity.

[0044] B) Gas drive unit

[0045] The gas drive unit forms the actual drive of the output system and can be connected to the operating unit (A). The gas drive unit consists of at least a housing, one or more gas generation units and contact elements. The gas drive unit is mechanically and electrically connected to the operating unit and the active substance container (C). In order to increase patient safety and to prevent tampering, it is also conceivable that the gas drive unit contains the entire control, regulation and monitoring electronics, including sensors, communication elements (e.g. radio) and energy sources (e.g. batteries).

[0046] The gas generation is controlled by a programmable current discharge. Sensors and intelligent electronics either in the gas drive unit or in the operating unit enable a reliable delivery of the active substance. The delivery can also be suspended if necessary, for example in the event of discomfort due to an analgesic dose that is set too high. In addition, the delivery rate can be adjusted at any time during the delivery. Thus, for example, the delivery amount can also follow a preprogrammed dosage profile.

[0047] As shown in FIGS. 8 and 9 , the gas drive unit can already be connected or welded to the housing 6 or to the active substance container 4 during production. However, it can also be connected to it only when it is provided. The connection should be arranged in such a way that an undesired gas outflow is prevented and the connection withstands the necessary gas pressure generated for the output of the active substance. In addition, a passive overpressure protection can also be integrated, which allows controlled venting of the gas chamber when a critical overpressure is present.

[0048] C) Active substance container

[0049] The active substance container contains the medium to be delivered. This active substance container is either already prefilled or filled by a provider (pharmacist, care worker, etc.) or the patient himself. Filling is greatly simplified and made safe by a correspondingly designed design or separate auxiliary devices, so that the drug can be easily mixed or stirred shortly before it is dispensed.

[0050] The active substance container can be designed in the form of a commercially available syringe (FIG. 8a). In this case, the piston acts as a medium separator between the gas and the medium to be conveyed, but other possible forms for separating the conveyed medium and the gas are also possible, such as, for example, a "bag in a bag", a "bag in a dimensionally stable housing" or a "bag in a dimensionally flexible and volume-stable housing" (FIG. 8b). Technically, an inflatable membrane or a bladder or balloon is also conceivable as a displacer (FIG. 9b or 9c).

[0051] The active substance container should meet different requirements in a manner adapted to the application, in particular its material should have an optimized compatibility with the active substance and minimal or no gas diffusion at all. The transfer of gas through the medium separator into the medium to be conveyed should always be minimal and should not exceed a set maximum value. This can be achieved by suitable material selection or coating or multilayer construction. Protection against light or UV radiation can also be achieved in this way.

[0052] The active substance container can also be protected against heating by an additional cold protection system or kept warm by a heat system.

[0053] It is also conceivable that a bag can be folded into the active substance container, which bag can then be squeezed out by a piston and the active substance can be dispensed in this way ( FIG. 9 a ).

[0054] D) Connection system

[0055] As the connection system, a standard system which is already marketed is preferably used. This makes it easier for the nursing staff to operate the device, for example.

[0056] List of reference numerals:

[0057] (1) Control unit

[0058] (2) Adapter

[0059] (3) Piston

[0060] (4) Container for active substances

[0061] (5) Connectors for injection devices

[0062] (6) Housing

[0063] (7) Gas generation unit

[0064] (8) Electronic device + possible battery + possible display + possible operating elements

[0065] (9) Diaphragm / Balloon / Active Substance

Claims

1. A device for conveying a conveyable medium by displacement with the aid of a gas which can be generated by a gas generating unit, The conveyable medium can be gaseous, liquid, viscous, pasty or powdery and is suitable for the targeted, controlled, regulated and monitored delivery of the conveyable medium to organisms, in particular humans, animals or plants, or to technical systems (machines, installations, etc.).

2. The device according to claim 1, As transportable media, when used in the technical field, drugs or active substances in liquid, dissolved or viscous form are provided, but also any auxiliary substances and liquids that can be transported by the system, as well as lubricants, protective agents or reagents (grease, oil, reagents, etc.).

3. The device according to claim 1 or 2, It consists of an operating, control, regulation, monitoring and communication unit (A), a gas drive unit (B), an active substance container (C) and a connection system (D).

4. The device according to any one of the preceding claims, The operating, control, regulation, monitoring and communication unit (A) is suitable for implementing one or more of the following properties: a) a start function for optimal start of the delivery flow; b) indirect control of the output variable by means of temperature, pressure and current measurements over time; and c) Bolus function for responding to higher required doses for a short period of time.

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