Device for dispensing active ingredients or conveyable substances in a targeted, controllable, and regulatable manner using a gas generating cell

Abstract

The aim of the invention is to dispense a conveyable medium, which can be gaseous, liquid, viscous, pasty, or pulverulent, into an organism (human, animal, plant) or onto a technical system for example in a targeted, controlled, regulated, and monitored manner by means of a displacement pumping principle using a gas produced by a gas generating cell. Medicaments or active ingredients in a liquid, dissolved, or viscous form are possible as conveyable media but any type of supporting substance and liquid which can be conveyed by the system, as well as lubricants or protective agents (grease, oil) or reagents, are also possible as conveyable media. The system should be inexpensive to produce and be suitable for an economical mass production, and additionally expendable partsand wear parts should be easy to replace. The operation and correct set-up of the device as well as starting, pausing, or stopping the dispensing process should be easy, understandable and designed such that the probability of faults is minimized and the safety of the patient is maximized or the reliable operation of the technical system is ensured. This is achieved by the system describe below, as disclosed in the independent patent claim (1) and the dependent patent claims (2) to (4). The system consists substantially of the following parts: a) an operating, control, regulating, monitoring, and communication unit (A); b) a gas drive unit (B); c) an active ingredient reservoir (C); and d) a connection system (D).

Description

[0001] Device for the targeted, controllable and adjustable release of active ingredients or deliverable substances by means of a gas development cell

[0002] The present invention relates to a device for the targeted, controllable and adjustable release of active substances or deliverable substances by means of a delivery pressure built up by one or more gas development cells.

[0003] A large number of devices are available on the market for delivering small quantities of liquid or viscous substances according to a predetermined, precisely maintained constant or variable delivery quantity per time, for delivering active substances or deliverable substances to a human, animal or biological organism, primarily for improving, changing or maintaining its state of health and / or for influencing the body's own processes.

[0004] Commercially available devices for delivering active ingredients or other pumpable substances in humanitarian or veterinary medicine operate electromechanically, using spring preload, or are based on elastomers. Peristaltic pumps are also known. Electromechanical systems are characterized by precisely controllable dosing, but these systems are relatively large compared to the pumped volume. Spring-driven systems, like elastomer pumps, are inaccurate and unreliable due to their design and the lack of electronics.

[0005] The gas generation cell technology underlying the present invention has not yet been used for dosing systems in the medical field to build a market-ready product that closes the gap between precise, relatively large, and expensive electromechanical systems and simple, rather inaccurate, and comparatively inexpensive spring or elastomer pumps. However, the required reliability and accuracy could not yet be achieved with the existing possibilities of gas generation cell technology.

[0006] The present invention is therefore based on the object of specifying a device for the targeted, controllable and adjustable release of active substances or conveyable substances by means of a conveying pressure built up by a gas development cell, which is characterized by a compact size, its comparatively easy-to-control conveying technology and the conveying accuracy and controllable discharge that can be achieved.

[0007] The technological progress of the past decades in the electronics industry and the current state of knowledge based on many years of experience with the gas development cell have contributed to the solution of this problem, whereby it has now become possible to combine the advantages of the small size of the gas development cell drive with corresponding intelligent electronics in order to build a very small, reliable, controllable, adjustable, monitorable and safe dosing system that achieves the necessary dosing accuracy that is significantly improved compared to spring and elastomer pumps.

[0008] The advantages over current systems include its smaller size, simpler construction, increased mobility and independence, lower complexity, improved accuracy, electronic control, functional monitoring, digital communication, and easier filling of the system. Compared to gravity-driven infusion systems, the system is characterized by its position-independent functionality, which is independent of the prevailing gravitational force and also functions in zero gravity.

[0009] The object of the invention is to use the conveying principle of displacement by means of gas produced by one or more gas development cells to deliver a conveyable 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 to a technical system such as machines or plants. Possible conveyable media can be medications or active ingredients in liquid, dissolved or viscous form, but also any type of supporting substances and liquids that can be conveyed using the system, as well as lubricants (grease, oil) or reagents when used in technical areas. The system should be able to be manufactured cost-effectively and be suitable for efficient mass production, and consumables and wearing parts should be easy to replace.The operation and correct setting of the device as well as the starting, pausing, or stopping of the delivery process should be simple, understandable, and designed in such a way that the likelihood of errors is minimized and patient safety is maximized, while ensuring reliable and safe operation of the technical system.

[0010] This object is achieved by the system described below, as disclosed in independent claim 1 and the following claims 2 to 4.

[0011] According to Figure 1, the system essentially consists of the following parts: a) an operating, control, regulation, monitoring and communication unit (A); b) a gas drive unit (B); c) a reservoir for active ingredient or deliverable substance (C); and d) a connection system (D).

[0012] A) Operating unit (operating, control, regulation, monitoring and communication unit)

[0013] The control unit consists of a housing, a display (e.g. LCD), operating elements (e.g. buttons), a power source (e.g. button battery or rechargeable battery), components for wireless communication and electronic components that fulfill the functionalities described below.

[0014] The most important functions include one or more of the following features: a) a start function for optimal start-up b) indirect control of the delivered quantity by means of temperature, pressure and current measurement over time, and c) a bolus function for reacting to temporarily higher required dosages.

[0015] The latter can be achieved through a controlled discharge current or through a defined gas pressure reservoir with a release valve. The time required until the next pressure buildup can be used to naturally prevent excessive bolus delivery.

[0016] The device can be easily set (dispensing rate ml / h, total amount ml, etc.) and started using the controls and the display.

[0017] The control unit features electronics that enable wireless communication, e.g., with a PC, tablet, or smartphone. This allows all necessary values ​​to be precisely set and, if necessary, a time sequence to be programmed. Furthermore, the device can be started, stopped, or paused without contact. Secure monitoring of the delivery and patient networking, e.g., via blockchain technology, is also possible.

[0018] The system can also be expanded to include a device for troubleshooting or problem solving, which can, for example, clear a blockage using a pressure pulse. Such a pressure pulse can be implemented using appropriately switched valves, pistons, springs, or detectors.

[0019] A constant active ingredient dosage can be achieved through intelligent control of the gas generation cell using pressure and temperature measurement with a corresponding control algorithm and appropriate control of the gas generation cell. The dispensed volume / active ingredient dosage is controlled indirectly via pressure and temperature measurement. The general gas equation applies: f (p, T, V) = constant.

[0020] The gas production, or discharge current in mAh, is "normalized" (normal pressure @ 20°C) to integrated. The gas production of the gas generation cells is known and controllable. As an alternative to this control method via pressure / temperature, a combination with a separate level measurement system is also conceivable, such as piston position measurement or flow measurement of the discharged quantity.

[0021] The gas diffusion through the housing / bag of the active ingredient to be delivered is calculated using the diffusion function (ml) Vd = f (p, T, V, t). This allows the current gas quantity, or the active ingredient (medication) volume, to be calculated at any time using the pressure and temperature measurements.

[0022] After activating the dispenser function (app, button, etc.), the control electronics and firmware can assume that a new, fully filled active ingredient reservoir is present in the device. All counters / integrators can be set to "zero," meaning a fill level of 100% is assumed.

[0023] The drug reservoir size can be detected automatically (HW coding on the reservoir) or determined via the Uo voltage of the respective gas generation cell package. The cell's charge level can be monitored simultaneously at startup via voltage monitoring.

[0024] Type Uo (new) Un(@1800hm) tn (1800hm)

[0025] 100ml 0.5...1.5V < 0.45V 15min

[0026] 200ml 1.0...3.0V < 0.90V 15min

[0027] 500ml 2.5...5.0V < 2.00V 15min

[0028] Quick start and learning phase

[0029] Figure 2 outlines the initial start-up of the active ingredient dispenser, during which the gas generation cells are rapidly discharged until a single cell voltage of less than 0.4V is reached (conditioning). Only at this voltage point does the gas generation cell enter the hydrogen gas production process. The rapid discharge of the gas generation cells now continues up to a pressure of 0.15 bar; here, for example, the piston friction of a delivery piston is overcome. The pressure increase (gradient) can be monitored in the start position, and a dead volume can also be compensated for.

[0030] The pressure is increased until pressure equilibrium ("active ingredient delivery") is achieved. This pressure is recorded as "system pressure" and is used as a control basis for further evaluations. If the device later enters one or more error states, the learning cycle could be triggered again. It can also be monitored whether the maximum system pressure (final pressure) has already been exceeded in the start-up phase, thus making proper function impossible from the outset.

[0031] Incident "blocked"

[0032] If, despite continued gas production, pressure equilibrium is not achieved (as shown in Figure 3), or the maximum theoretical pressure is exceeded, the control system can be trained to assume that the system is blocked and consequently sends an error message or signals this error on the device itself.

[0033] Leakage incident

[0034] If the pressure does not increase despite gas production, or even tends toward zero again as shown in Figure 4, the control system can be configured to assume the presence of a leak. As mentioned above, the drug dispenser signals this error and / or issues an error message.

[0035] Pulse operation

[0036] Figure 5 shows the case in which the gas development cell is controlled in "pulse mode" (approx. 1 ml in 22 min). Discharge at 180 ohms results in a gas rate of 2.7 ml / h. The pressure measurement signal should rise and then fall again as the active ingredient flows. The piston movement can be determined in this way. The stick-slip effect of the piston (static friction / sliding friction) can be determined via the pressure measurement, as a further indication of the piston movement, or rather the function of the dosage.

[0037] Pulse operation with constant minimum gas rate

[0038] It is also possible to operate the gas generation cell at a "constant minimum" gas rate and superimpose the "pulses," as shown in Figure 6. This results in more constant gas production because it requires much shorter "start-up phases" of the gas generation cell.

[0039] Compensation for gas diffusion

[0040] The gas diffusion through a syringe barrel or an outer bag can also be continuously compensated by the control system by realizing an increasing gas rate.

[0041] B) Gas drive unit

[0042] The gas drive unit forms the actual drive of the delivery system and can be connected to the control unit (A). The gas drive unit consists at least of a housing, one or more gas development cells and contact elements. The gas drive unit is mechanically and electrically connected to the control unit and the active ingredient reservoir (C). To increase patient safety and to protect against tampering, it is also conceivable for the gas drive unit to contain all of the controlling, regulating and monitoring electronics including sensors, communication elements (e.g. radio) and energy source (e.g. battery).

[0043] The gas development is controlled by a programmable current discharge. The sensors and intelligent electronics, located either in the gas drive unit or the control unit, enable reliable delivery of the active ingredient. Delivery can also be paused if necessary, for example, if discomfort occurs due to an overly high painkiller dosage. Furthermore, the delivery rate can be adjusted at any time during delivery. For example, the delivered amount could also follow a preprogrammed dosage profile.

[0044] As shown in Figures 8 and 9, the gas drive unit could either be connected or welded to a housing 6 or an active substance container 4 during production. However, it could also be connected to them only upon delivery. The connection should be designed in such a way that an unintentional gas leakage is prevented and that the connection can withstand the gas pressure generated necessary to deliver the active substance. A passive overpressure protection device, which enables controlled venting of the gas space in the event of critical overpressure, could also be integrated.

[0045] C) Active ingredient reservoir

[0046] The active ingredient reservoir contains the medium to be delivered. This is either prefilled or filled by the provider (pharmacist, nursing staff, etc.) or the patient themselves. Filling is made as simple and safe as possible by a suitably designed construction or a separate auxiliary device, making it easy to mix or blend medications shortly before dispensing.

[0047] The active substance reservoir can be designed in the form of a commercially available syringe ( Figure 8a ). The piston acts as a media separator between the gas and the medium to be pumped; however, other possible forms for separating the pumped medium and gas are also possible, such as a "bag within a bag," a "bag in a rigid housing," or a "bag in a flexible and volume-stable housing" ( Figure 8b ). An inflatable membrane or some kind of bladder or balloon as a displacer are also technically conceivable ( Figure 9b or Figure 9c ).

[0048] The active ingredient reservoir should meet various application-specific requirements. In particular, its material should exhibit optimized compatibility with the active ingredient and minimal or no gas diffusion. The transfer of gas through the media separator into the conveyed medium should always be minimal and must not exceed any set maximum values. This can be achieved through a suitable choice of material or coating, or a multilayer structure. Protection against light or UV radiation can also be achieved.

[0049] The active ingredient reservoir can also be protected from heating by an additional cold protection system or kept warm by a heating system.

[0050] It is also conceivable that a bag can be clicked into the active ingredient reservoir, which can then be squeezed out via a piston and thus expels the active ingredient (Figure 9a).

[0051] D) Connection system

[0052] The preferred connection system is a standard, established system on the market. This makes handling the device easier, for example, for nursing staff.

[0053] List of reference symbols

[0054] (1) Control unit

[0055] (2) Adapter

[0056] (3) Piston

[0057] (4) Active ingredient container

[0058] (5) Connection for infusion set

[0059] (6) Housing

[0060] (7) Gas evolution cell

[0061] (8) Electronics + possibly battery + possibly display + possibly control element

[0062] (9) Membrane / Balloon / Active ingredient

Claims

Patent claims 1. Device for conveying a conveyable medium by displacement using gas which can be produced by a gas development cell, wherein the conveyable medium is gaseous, liquid, viscous, pasty or powdery, and is suitable for delivering the conveyable medium in a targeted, controlled, regulated and monitored manner to an organism (in particular a human being, an animal or a plant) or to a technical system (machine, plant etc.).

2. Device according to claim 1, wherein the conveyable medium is medication or active ingredients in liquid, dissolved or viscous form, but also any type of supporting substances and liquids that can be conveyed with the system, as well as lubricants, protective agents or reagents (grease, oil, reagents etc.) when used in the technical field.

3. Device according to claim 1 or 2, comprising an operating, control, regulating, monitoring and communication unit (A), a gas drive unit (B), an active ingredient reservoir (C) and a connection system (D).

4. Device according to one of the preceding claims, wherein the operating, control, regulating, monitoring and communication unit (A) is suitable for performing one or more of the following features: a) a start function for optimal commencement of a conveying flow; b) an indirect control of the dispensing quantity by means of temperature, pressure and current measurement over time; and c) a bolus function for responding to short-term higher required dosages.

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