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WO2014072079A1 - Valve thermo-rhéologique, régulateur de débit et dispositif doseur - Google Patents

Valve thermo-rhéologique, régulateur de débit et dispositif doseur Download PDF

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Publication number
WO2014072079A1
WO2014072079A1 PCT/EP2013/053804 EP2013053804W WO2014072079A1 WO 2014072079 A1 WO2014072079 A1 WO 2014072079A1 EP 2013053804 W EP2013053804 W EP 2013053804W WO 2014072079 A1 WO2014072079 A1 WO 2014072079A1
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WO
WIPO (PCT)
Prior art keywords
medium
valve
flow
temperature
line section
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Ceased
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PCT/EP2013/053804
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German (de)
English (en)
Inventor
Tilmann Rogge
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Individual
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Individual
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14526—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons the piston being actuated by fluid pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/1454—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons spring-actuated, e.g. by a clockwork
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16877—Adjusting flow; Devices for setting a flow rate
    • A61M5/16881—Regulating valves
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16K—VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
    • F16K13/00—Other constructional types of cut-off apparatus; Arrangements for cutting-off
    • F16K13/08—Arrangements for cutting-off not used
    • F16K13/10—Arrangements for cutting-off not used by means of liquid or granular medium
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16K—VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
    • F16K31/00—Actuating devices; Operating means; Releasing devices
    • F16K31/02—Actuating devices; Operating means; Releasing devices electric; magnetic
    • F16K31/025—Actuating devices; Operating means; Releasing devices electric; magnetic actuated by thermo-electric means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M2005/1401—Functional features
    • A61M2005/1405—Patient controlled analgesia [PCA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M2039/226—Spindles or actuating means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0272—Electro-active or magneto-active materials
    • A61M2205/0288—Electro-rheological or magneto-rheological materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/3653—General characteristics of the apparatus related to heating or cooling by Joule effect, i.e. electric resistance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/227—Valves actuated by a secondary fluid, e.g. hydraulically or pneumatically actuated valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic

Definitions

  • the invention relates to a thermo-rheological valve according to the preamble of claim 1.
  • the invention relates to a flow regulator according to the preamble of claim 1 1 and a metering device according to the preamble of claim 14th
  • basal bolus therapy In the case of various chronic diseases, it is necessary for patients to receive regular medication as part of a basal bolus therapy. This includes a continuous addition of the drugs with the so-called basal rate and, if necessary, a significantly higher so-called bolus delivery. Such therapy is desirable, for example, for the addition of insulin to diabetics or other diseases that can be treated with hormonal therapy, such as cardiac arrhythmias or immune disorders.
  • hormonal therapy such as cardiac arrhythmias or immune disorders.
  • basal rate usually of the order of 0, 1 ⁇ / min. This low rate is difficult to control accurately.
  • a suitable device By a suitable device, it is in principle possible to meet the needs of the drug or drug over several days.
  • the basal rate which is intended to replace the continuous production of endogenous insulin
  • the bolus delivery which is necessary after meals.
  • bolus delivery it is necessary that a greatly increased flow rate can be generated in the short term.
  • a disadvantage of this approach is the low manufacturing tolerance that is permissible for the metering of a regularly aqueous medium.
  • occlusion especially in the dosage of insulin, .was means that the drug can not be injected. This can, for example, from a blockage of the cannula, for example! by crystallization of insulin, resulting. For this reason, an occlusion monitoring is necessary, which draws attention to this malfunction at the latest after a few hours. Furthermore, it is necessary to avoid overdoses, as a very strong overdose of insulin may have a lethal effect.
  • thermal flow measurements are suitable. Even in the range of 0.1 pL per minute, flow rates can be reliably measured with the aid of thermal measuring methods.
  • a flow measurement is known for example from US 6,813,944.
  • Such sensor systems typically consist of at least one heating element and further temperature sensors.
  • hormonal agents such as insulin
  • such systems as described in DE 41 27 675 A1, used in external infusion devices as flow monitors. But even with an indirect measurement of the flow by means of a working medium requires at low flow rates and high accuracy high heating element temperature and a correspondingly high heating current, whereby the energy consumption makes this measurement method for portable devices disadvantageous.
  • micro-valves with classic shut-off for dosing such small flows disadvantageous because a normally closed (“normally-closed") function must be implemented to prevent uncontrolled release of active ingredient, for example in case of power failure,
  • Impurities of the valve seat can lead to an uncontrolled leakage, which represents another source of danger in the drug dosing.
  • Valves Without eweglrche parts or without shut-off are also known in the metering, for example, from US 5, 101, 848th Aqueous media are cooled below freezing with the help of cooling elements, so that the flow stops. If necessary, the medium is heated by a heating element and the valve is opened again.
  • the use of cooling elements is very energy-consuming, and is therefore not suitable for portable devices.
  • no "normally-closed" function can be realized.
  • valves without moving parts based on electro-rheological or magneto-rheoiogical principles are known.
  • the applications are mostly in the field of vehicle technology. These are energy intensive, show no "normally-c! Osed u" function and can usually only change the flow by a factor of 5. Overall, they are therefore not suitable for portable micro dosing applications.
  • the invention has for its object to overcome the above-mentioned disadvantages to provide a valve which is able to safely and reliably enable the dosage even the smallest amounts of a medium.
  • the valve should be simple and inexpensive to produce and thus suitable for the production of disposable devices for dosing particular medical agents.
  • the object of the invention is also to provide a corresponding flow regulator and a corresponding metering device.
  • thermo-rheological valve with the features of claim 1
  • flow regulator with the features of claim 1 1
  • metering device with the features of claim 14th
  • thermo-rheological valve for a pressurized medium with temperature-dependent viscosity, comprising a conduit section for passing the medium and a heating device with at least one heating element, which heating element for heating at least a portion of the. Line section and.
  • the medium guided therein is formed, characterized in that dimensions of the line section, in particular its length and / or cross-section, and the medium are selected with respect to its temperature-dependent viscosity coordinated so that in a first operating condition of the valve at a first operating temperature, preferably a state of the line section unheated by the heating element, a fluidic resistance of the valve is set so that at a predetermined pressure difference between the ends of the line section, a flow rate of the medium from 0 ⁇ / min to 200 ⁇ / min, preferably about 0.02 nl / min to 20 ⁇ / min, most preferably from about 0.2 nl / min to 2 ⁇ / min, caused by the line section est.
  • a flow regulator according to the invention is characterized by a valve according to the invention, at least one temperature determining device, which temperature determining device is arranged on the heating element of the valve or in the medium, and an electronic evaluation device which is designed from measured values of the temperature determining device and preferably by comparison with stored calibration values by means of thermal flow measurement to determine a flow of the medium through the valve in response to the heating of the throttle portion of the valve, and which is further adapted to control the flow by reacting on the heating element to adjust its heating power, which for heating the throttle region used energy is additionally used for the thermal flow measurement.
  • a dosing device for a dosing medium, preferably a medicinal agent, most preferably insulin or insulin analogs, comprises: at least one reservoir containing the dosing medium, preferably insulin cartridges; and at least one pressure means, preferably compression spring, which is designed to provide a delivery pressure for dispensing the dosing medium from the reservoir.
  • the metering device is characterized by a valve according to the invention or a flow regulator according to the invention for regulating a dosage of the metering medium, wherein the medium in the valve acts as a working medium, for which purpose the medium on the one hand, upstream of the heatable line portion of the valve, is acted upon by the pressure medium with said pressure, and for what purpose the medium on the other hand, downstream the heatable line section of the valve is designed and arranged to supply the accumulator with the delivery pressure, a difference between said pressure and the delivery pressure substantially corresponding to the pressure difference between the ends of the line section, and by an electronic control system and / or or rules of operation of the metering device, which control with the heating device of the valve and / or the evaluation device of the flow regulator is in signaling active connection or includes this.
  • the valve according to the invention may be characterized in that a substance or mixture of substances whose viscosity at 30 ° C. is greater than about 0.005 Ns / m 2 is selected as the medium (working medium).
  • the valve according to the invention may be characterized in the course of another development in that it has at least a first, unheated and a second, heated operating state with associated first and second operating temperature, wherein the medium at the second operating temperature is substantially thermally stable, preferably that the Temperature in the second operating state is smaller a degradation temperature of the medium, while about 45 to 220 ° C, preferably about 55 to 160 ° C, most preferably about 65 to 130 ° C, is.
  • the valve according to the invention can be characterized in that the line section is designed in the manner of a grid in the form of a flat, preferably oblong-planar structure with a number of apertures oriented transversely to the longitudinal extension of the structure for a flow through the medium. most preferably, the number of apertures and their length varies with a diameter of the apertures.
  • the grating may be formed in a thermosetting photoresist, preferably by means of optical lithography, or the grating may be formed as a metallic grid, preferably by electroplating on an electrically conductive made • support surface 'eines' gleich mandat' photoresist, barren, the grating may be formed as a woven, preferably with metallic filaments network.
  • the grid can be inserted into a holding structure, preferably a HaS test structure made of a thermoplastic material, with which the grid is fluid-tightly connected, preferably cohesively.
  • the line section may be formed in the manner of a channel or trench in a first substrate, preferably by lithographic patterning of a resist layer.
  • the first substrate preferably a resist layer
  • the first substrate can be arranged on a semiconductor substrate, in which semiconductor substrate preferably at least individual components of the heating device, most preferably the heating element or a temperature determination device for the heating element or for the medium, and / or components of the control device are formed.
  • the line section is formed in the manner of a capillary or a capillary tube, preferably in the form of a glass capillary with plastic coating.
  • the heating element is formed as a wire and attached from the outside to the capillary, preferably wound around the capillary, wherein the wire is most preferably stored outside in the air; or that the heating element is introduced into the capillary, preferably in the form of a wire, which wire is most preferably passed through the capillary or looped in and out on one side of the capillary; or that the heating element is formed as a metallic deposition on the inside of the capillary.
  • the flow regulator according to the invention may be characterized in that, in particular for a transit time measurement, a further temperature sensor is arranged in the medium upstream of the heating element, wherein preferably the two temperature sensors are electrically connected to one another via a bridge circuit.
  • a further temperature sensor is arranged in the medium upstream of the heating element, wherein preferably the two temperature sensors are electrically connected to one another via a bridge circuit.
  • Fig. 1 shows schematically an embodiment of the invention
  • Fig. 2 shows schematically the cross section of a grid for the production of
  • Fig. 3 shows schematically a possible embodiment of a built-in a housing grid for a valve according to the invention
  • Fig. 6 shows schematically the use of a capillary tube for the production of a valve or flow regulator or metering system according to the invention.
  • the dosing system is intended for basal bolus insulin therapy. This requires a continuous release of active ingredient and, in addition, a significantly increased Boiusga- be when needed, for example, after meals.
  • active ingredient for example, insulin
  • Boiusga- for example, insulin
  • on the body portable devices insulin pads
  • a compact design requires the use of highly concentrated drug and thus a very accurate dosage.
  • the invention provides an indirect dosing device which doses a working medium and thus expels an active ingredient (generally a dosing medium).
  • a working medium enables the realization of a thermal Theological valve, a flow controller based thereon and a metering system or a Dosiervorrumbletung, which / s at least the valve according to the invention comprises.
  • the dosing system comprises a reservoir in which a working medium. is pressurized, for example by a spring. About a throttle, the working fluid is pressed into a second chamber, which is connected to a drug cartridge. Depending on the metered amount of the working medium, an appropriate amount of active ingredient is injected into the body.
  • the valve principle is based on the control of the flow through a throttle by means of the change in the viscosity of a fluid, which acts as a working medium. Fluids with a strong temperature-dependent viscosity are used for this purpose. A heating element in the throttle area heats the fluid, thus reducing its viscosity and thus increasing the flow - this is the opening of the valve.
  • a flow measurement is made by measuring the temperature generated by the heating element.
  • the heating element is thus both part of the valve and part of the flow measurement.
  • Valve and flow meter are thus one unit and represent a flow regulator.
  • the feeders of the metering system incorporating this flow regulator are dimensioned such that the pressure drop substantially drops off the restrictor, even if the restrictor is heated.
  • the simplest conceivable design of the dosing system 1 is shown schematically in FIG. It includes a throttle point (throttle area) 2 with a
  • FIG. 1 Also shown in FIG. 1 is a line section 5, soft line section 5 comprising the already mentioned throttle section 2.
  • Said line section 5 connects a storage chamber 6, in which a working medium 7, with an Ai beitshunt 8 in fluidic operative connection.
  • the working chamber 8 is connected via a Wirkmittef, such as a piston 9, in operative connection with a further memory 10, for example, a Insulinkarpulle, which memory 10 contains a dispensed metering 1 1.
  • a further memory 10 for example, a Insulinkarpulle, which memory 10 contains a dispensed metering 1 1.
  • On the located in the storage chamber 6 working fluid 7 can be acted upon by means of another active or pressure means 12 for generating a delivery pressure, said means 12 may be formed, for example, as a piston-spring means.
  • the heating element or the heating device 3 is designed to heat a portion of the line section 5, namely the throttle point 2.
  • the invention provides by suitable choice of the dimensions of the line section 5, in particular in the throttle region 2, and tuned, temperature-dependent properties of the working medium
  • Fig. 7 is a thermo-rheological valve which will be specified in more detail in the present specification.
  • the main field of application of the dosing method realized herein by use of the valve, the flow regulator or the dosing device is the integration in a body-worn device which can cover the insulin needs of diabetics for several days. This device should be able to generate both the basal rate and bolus deliveries.
  • the metering process can implement these requirements in a structurally simple manner and is thus suitable for low-cost production of corresponding metering devices.
  • valve function can be carried out in the context of the present invention without moving parts with a heating element, the flow measurement by means of one or more temperature sensors. Both heating elements and temperature sensors are very inexpensive to manufacture.
  • indirect dosing i. the separation of working and dosing a measurement of the metered volume mitteis thermal measurement, without affecting the dosing.
  • An essential aspect of the invention or the proposed valve is that its or its function on a strongly temperature-dependent medium, the Ar working medium, based.
  • Operating principles that are sensitive to even slight temperature fluctuations are usually technically uninteresting.
  • the human body is used as a temperature-stable heat storage, which greatly reduces disturbing temperature fluctuations.
  • thermal flow measurements are technically difficult and essentially possible only by thermal processes.
  • the measuring principles of thermal flow meters are known per se (anemometric, calorimetric or transit time measurements).
  • the invention is not a flow meter, but among other things, a flow regulator whose valve and measuring function are not separated.
  • the goal is - as already mentioned - the production of small, lightweight Insuiinpads for single use.
  • active substance drug
  • a memory with the working medium is necessary.
  • a control unit with a corresponding power supply may be required.
  • a very simple control unit can be supported via Bluetooth from an external device. The minimum total volume is thus determined by the active ingredient, the working medium and the energy storage.
  • Optionally required housing parts can be manufactured with known low-cost techniques, such as injection molding or the like.
  • Technically demanding are the production of Drosselstelfe (the line section according to claim 1), the electronics and the working medium.
  • the electronics must allow accurate temperature measurements and preferably also perform a power measurement of the heating element.
  • the basal bolus therapy is especially important for diabetics. It is intended to mimic the natural insulin production of the body, which rises sharply, especially at meals, and otherwise occurs at a low level. Depending on the individual insulin need and the insulin concentration used, the base flow should be adjusted. Typical quantities are insulin units (I.E.) with a volume of 10 ⁇ . After a meal (3 times a day) diabetics need about 2-10 l. E. The bazaar gives about half of the total insulin, the bofus after meals the other half.
  • a delivery period can be selected.
  • this bolus injection is done by syringes within seconds. This fast insulin dose will not be physiologically optimal.
  • a bolus injection duration of 5-15 min seems to make sense. This requires a maximum throughput that is 96 to 32 times higher than basal rates.
  • the operating temperature is the temperature of the entire system during use.
  • the device or the dosing device is preferably worn directly on the body under the clothing. Normally, this leads to very stable temperature conditions in the range of slightly above 30 ° C and a homogeneous temperature of the entire dosing device. This is referred to below as the operating temperature (T B , is).
  • T B operating temperature
  • a temperature range with upper and lower limits (T B , max and T ß , min) must be defined, within which the system works without problems; For a further temperature range, a short-term temperature change can be tolerated.
  • the heating temperature T H is the temperature of the heated throttle or line section. Due to the small dimensions of the throttle (micrometer range), the working fluid is heated almost instantaneously when it reaches the heated throttle range. The viscosity ⁇ ⁇ ) of the working medium then corresponds to the temperature in the throttle area.
  • the pressure difference ⁇ results from the pressure pspeic er, which is generated by a pressure generating device in the working container, in which the working medium is located, and the pressure Pommer, which corresponds to the injection pressure, which is necessary to the active ingredient in the body inject.
  • This pressure consists of constructive properties of the drug injection device and physiological conditions and has small fluctuations.
  • the valid average must be determined, which is usually in the range of 300-500 hPa. Minor pressure fluctuations around this mean mittein to temporally, particularly when the pressure ps pe Icher significantly higher than this pressure fluctuation is.
  • the pressure Ps eicher should be well above 500 hPa, but better at 2000 - 3000 hPa. If a simple pressure generating device produces a change in the pressure with the delivered volume, this can be taken into account in the valve control.
  • the viscosity of the working fluid is very dependent on temperature. Overall, a viscosity reduction should result by a factor of 20-100.
  • Vaseline a pasty medium with a crystalline wax content
  • body temperature 38 ° C
  • 60 ° C 60 ° C
  • the working medium is chosen in the context of the invention so that it changes its flow properties sufficiently strong with the temperature.
  • Newtonian fluids is here spoken of a temperature-dependent viscosity.
  • media with very high temperature dependence of the viscosity such as fats, oils or waxes, are to be considered only to a limited extent as Newtonian liquids. Nevertheless, one can. edium a ratio for deformation force and deformation rate depending on the temperature and other factors are assigned. This ratio is also referred to below as viscosity.
  • a minimum requirement for the working medium may be that its viscosity changes at least by a factor of 10 in the temperature range between 30 ° C and 100 ° C.
  • a medium or substance mixture is selected as the medium, preferably oil, fat, wax, gel or a pasty medium whose viscosity when heating the throttle region by a factor of at least about 3, preferably at least about 6, most preferably about 9 changes, preferably at a temperature difference of about 50 K, most preferably in a temperature range from 30 ° C to 80 ° C.
  • the viscosity is not subject to any restrictions downwards (thin liquid), but it should be significantly higher than the viscosity of water at this temperature, at least 0.005 Ns / m 2 at 30 ° C to simplify the Hersannon.
  • the upper limit of the viscosity is determined by the fact that the working medium should be deformable in the temperature range of the operating temperature at slow deformations without great force.
  • the heating temperature must not exceed boiling or Degradationddling, ie it must eim one heating be no outgassing '. For more information, see our efiects
  • Glycerin an alcohol compound having a viscosity change of the order of 1.0 Ns / m 2 and a viscosity change of a factor of 100 (20) in a temperature range of 20 ° C - 100 ° C (30 ° C - 80 ° C).
  • Lubricating oil of type SAE60 has a viscosity change by a factor of 40 (20) in a temperature range of 30 to 100 ° C (30 ° C - 80 ° C).
  • Vaseline A suitable pasty working medium is Vaseline, for example.
  • Vaseline has a melting range of 37 to 60 ° C. The reason for this melting range is a microcrystalline wax content based on stearin or paraffin, which melts in this temperature range.
  • the quality of the dosing system increases with the accuracy of the dosed quantity.
  • an indirect flow measurement is well suited.
  • the minimum requirement for a dosing system is the detection of an occlusion (a blockage of the injection lines).
  • the dosing system must at least within hours determine whether really active ingredient is delivered.
  • Thermal flow measurements are used today to measure the smallest flows. In this case, a temperature is always measured, which is generated by a heating element ih a flow. These measurements can also be done consecutively, superimposed, etc.
  • Three principles are used: anemometric, calorimetric and time-of-flight measurements.
  • the anemometric measurement utilizes the 'heat release' through a moving medium.
  • a simple example is a heated ohmic wire held in a flow. At constant heating current the resistance of the wire is measured. If the resistance increases, the wire has become warmer, the heat dissipation is smaller, consequently the flow has become smaller. Here an interface effect is observed (surface of heated body and flowing medium).
  • the calorimetric measurement measures the heat flow from the heat source to the medium.
  • the heating of the medium is measured by a heating element.
  • the heating power and the heat capacity of the medium plays a role.
  • On the basis of the heat output and the heating of the medium is closed on the heat capacity on the mass per time, which has flowed past the heating element.
  • the medium is heated in one known flow channel at one point and the time delay of the heating is detected downstream. The smaller the delay, the faster the flow.
  • the heated throttle (line section) in combination with the highly temperature-dependent working fluid can change the flow by at least one order of magnitude and thus represents a valve. It differs from a tempered throttle, which only stabilizes the flow.
  • the valve works without moving parts, which makes it different from most valves. Ventiie without closing body are usually known in connection with electro- or magnetic-rheological fluids.
  • the valve is preferably closed at the above-defined operating temperature and opened with a heated throttle. An important feature is that the pressure drops substantially at the throttle even when the throttle is heated or the valve is open.
  • a flow regulator is usually referred to as a combination valve (proportional) valve and flow meter. Depending on the measured values, the valve is controlled.
  • the present invention does not constitute such a combination: only temperature sensors are added to the valve. The continuity measurement is carried out in connection with the valve control by heating the line section. Conversely, each flow measurement also represents a valve function.
  • a flow measurement that does not affect the flow is not possible. This is due to the necessary low flow resistance of the supply and discharge lines. A thermal flow measurement is only possible if the medium moves sufficiently fast. At the low flow rates, a noticeable flow can only be achieved with small flow cross sections, at which the pressure drops significantly (throttle). If a throttling area is heated, a valve is obtained in the presently selected, special working medium.
  • the flow through the throttle depends on the 4th power of its diameter. Precise manufacturing with a throughput error below 5% requires a tolerance of less than 1.25%. For channel dimensions in the micro range, this requires accuracies in the nanometer range and is not associated with economically viable feasible ' effort possible, especially for disposable items.
  • Each throttle point must therefore be measured after production or the dosing device must be calibrated. With simple calibration measurements (eg without pressure and with maximum pressure) immediately before commissioning, the effective geometry can be completely determined and the system-specific dosing parameters can be determined.
  • a corresponding development provides that the measured values of the temperature sensors and other measured values, such as the heating power, are read out and that the heater is suitably activated.
  • the evaluation of the measured values and the control can be done either internally or by an external control unit.
  • direct inputs e.g. Bolusan- request, done by pressing the meter or by an external control unit.
  • Such external control devices are known per se and can be used e.g. be wirelessly connected via Bluetooth with the metering device.
  • the (metering) Ventii has a throttle, the (part) line section mentioned in claim 1, which is flowed through by a working medium.
  • the volume flow Q of the working medium through the throttle depends on the geometry, the pressure difference and the viscosity of the working medium.
  • the geomet- Tables 'shape of the throttle is' basically-freely selectable. It is to be expected with a strictly laminar flow.
  • the relationship in formula 1 approximates the relationship for the flow of simple channel geometry, temperature-dependent viscosity and pressure difference. More complex shaped structures can be calculated by parallel or series connection of the flow resistances (fluidic resistances). Likewise, the total flow resistance of the throttle can be generated by a plurality of successive throttle points or parallel throttle points.
  • the laminar flow can be calculated by a person skilled in the art with a precisely known geometry.
  • various computer simulation programs available.
  • T H eiz.max fvisk.max be at least about 20.
  • the dosing system can be manufactured micro-technologically in many different ways, in which known manufacturing techniques are used. In the following, three production variants are listed by way of example, which are complete allow a production of the critical Drosset designedmessers from 100 nm to over 100 ⁇ addition.
  • a lattice is referred to as a flat shape parallel to the cross-sectional area of the valve-closing area (throttle or line section).
  • This mold has openings through which the working medium can flow.
  • the flow resistance is determined approximately by the laminar tube flow (formula 1 a).
  • the thickness of the grid corresponds to the hole length and is approximately between 1 -20 ⁇ .
  • the total flow resistance reduces linearly according to the number of openings (number of holes).
  • the following table 1 indicates possible parameters for such grids, which are shown schematically in section in FIG. 2:
  • FIG. 2 shows a grid, which is denoted overall by the reference numeral 13.
  • the grid 13 is approximately rectangular in cross-section and has in its upper side 13 a and on its underside 13 b in cross-section triangular Just istsausappelInstitut 14.
  • a so-called exposed surface or a channel 13d is arranged, wherein in this area the already mentioned holes or openings 15 are provided, which are present-without restriction-arranged in a row next to each other.
  • electrical contacts 16 are provided, via which in particular electrical (heating) energy in the region of the throttle region (in the region of the holes) 15 can be supplied.
  • Optical lithography is a standard technique of microtechnology. By exposure and development flat resist layers are structured. The resist thickness can be adjusted to less than 0.1 pm using the spin parameters, and simple structures, such as circles with a diameter of less than 1 pm, can be imaged. However, the quality of the structures decreases with increasing aspect ratio.
  • Thermosetting photoresists such as SU8 offer the possibility of producing plastic structures up to an aspect ratio of 20.
  • the grid can also be used as a heating element, it can be metallized.
  • Metal deposition on surfaces is a standard technique of microtechnology and is done by, for example, steaming or sputtering).
  • the metallic layer thickness is to be set according to the desired heating resistor. A thermal deformation of the SU8 by heating leads to a stronger temperature dependence of the resistance and can be used advantageously for a temperature measurement.
  • thermoset lattice surface is by gluing or pressing into a flow kana to be provided for this purpose! of the valve and electrically contacted. Adjustment structures in the edge region outside the region of the hole structures can facilitate the adjustment and fixing (see Fig. 2).
  • Variant 2 Galvanized grid
  • Inverse photoresist structures can be made with similar fabrication parameters as described above. Electrodeposition on the electrically conductive carrier surface (wafer) of the patterned photoresist can be used to produce metallic structures which represent the inverse image of the photoresist. The resist is removed after completion of the electroplating, and a corresponding grid structure can be removed. A metallic grid can be electrically contacted and heated.
  • the preferred material for the deposition is nickel. Nickel electroplating is widely used in microtechnology and has the advantage that nickel has a relatively high thermal conductivity coefficient and is thus also well suited for temperature change.
  • Variant 3 woven grid
  • Woven meshes with hole diameters of less than 1 ⁇ m are commercially available with metallic threads. These can be taken with appropriate number of holes in a suitable frame and heated electrically contacted.
  • the diameter of the thin, pressure-loaded surface should be small. An elongated shape of the grids is therefore preferable to a round one. Of course, when using thin grid and support structures on the back largely prevent sagging.
  • Fig. 3 shows schematically a possible embodiment of the built-in a two-part housing 17 grid 13 with the following parameters: A mold 5 mm in length, 50 pm width (+ 20pm per page) and thickness of 5 ⁇ with 25 holes, hole pitch 200 pm. Welding by heat pulse with the preferred thermoplastic housing 13. Provided is also a (heating) resistor (platinum with 10 "7 ohm / m, width 50 pm, thickness 5 m, length 5 mm, resistance 2 ohms) The housing 17 is pressed and the grid 13 is briefly heated above the melting point of the thermoplastic so that it melts in the immediate vicinity of the grid and seals the housings in a fluid-tight manner a contact surface between the two housing parts.
  • a (heating) resistor platinum with 10 "7 ohm / m, width 50 pm, thickness 5 m, length 5 mm, resistance 2 ohms
  • Figures 4 and " -5 ' show a possible * channel-like construction of the line section, in particular according to the following table 2.
  • reference numeral 13d designates the actual channel within the choke region 2 formed between planar resist structures 18. Said arrangement is is arranged on a wafer substrate 19, in which also the associated (electronic) control and Ausw.erteech integrated 20. In the region of the channel 13d in the wafer 19, a trench or a trench structure 20 is formed with preferably etched back, whereupon The following is to be noted in more detail:
  • planar substrates such as wafers
  • electrical components can be realized on planar substrates, such as wafers.
  • lithographically thin-film conductor tracks can be applied to almost any planar material, in particular suitable are silicon wafers in which semiconductor effects can also be used (semiconductor technology).
  • This offers the possibility to create in the context of the invention or its embodiments used Schuleiterieri and also temperature sensors (semiconductor thermometer) on a semiconductor basis.
  • a resist layer having a readily determinable thickness can again be applied using conventional techniques and lithographically patterned (preferably with a crosslinking, well-adhering thermosetting plastic such as SU8).
  • This resist pattern 18 then constitutes, as a trench, the lateral boundary surface of the channel 13 d, which forms the throttle / line section 2.
  • the trench is covered with a further substrate 22, cf. 4 and 5.
  • the substrate is pressed, glued or bonded with other micronotechnical methods.
  • a trench structure may be structured in the cover substrate 22, which is suitably positioned and fixed over the electrical structures on the bottom substrate 19. is taken.
  • silicon etching is advisable from the rear side of the bottom substrate, so that only a thin silicon layer remains under the channel region.
  • SOj wafers with a backside etching to the insulation layer so that only an about 3 m thick membrane remains.
  • the heating structure 3 ' may be implemented as one element or in several elements.
  • the heating structure 3 ' should be designed so that the medium is heated as homogeneously as possible. For this purpose, a higher heat input is required in the input area than in the output area (for example, conductor loops more tightly packed or higher resistance).
  • thermosensory elements can be arranged on the substrate, which are shown in Figure 5 (left) at reference numeral 23. Temperature sensing elements 23 can be interconnected in pairs for a bridge schaitung. Furthermore, it is possible to bring a temperature sensor in medium contact upstream of the heating elements. This allows a simple integration of the operating temperature measurement and / or a simplified differential temperature measurement with other temperature sensor elements.
  • a further simple implementation in the production of a valve or flow regulator or dosing system according to the invention is the use of capillary tubes 24 according to FIG. 6.
  • Capillaries 24 with corresponding dimensions are commercially available (eg MikroQuartz® capillaries of 2 pm-800 [im] and are usually protected by a polyimide sheath.
  • the heating of the capillaries 24 preferably takes place with ohmic resistance 3.
  • Variant 1 Resistance wire 3 is wound around capillary 24 from the outside, wherein a higher heat input in the input area can be achieved by a denser winding in this area.
  • the wire should have a low heat storage capacity (thin wire), good thermally coupled to the Kapiiiare 24 and be stored outside freely in the air.
  • Variant 2 A resistance element, eg. B. platinum wire is introduced into the capillary tube (not shown). The wire is either carried or returned in the capillary to the input side and returned accordingly electrically contacted. The heating of the resistance element then leads to a direct heating of the working medium directly in the closing area.
  • a resistance element eg. B. platinum wire is introduced into the capillary tube (not shown). The wire is either carried or returned in the capillary to the input side and returned accordingly electrically contacted. The heating of the resistance element then leads to a direct heating of the working medium directly in the closing area.
  • a capillary can also be metallised on the inside, for example by means of the method known per se for thin-layer silver deposition on gold for mirroring. If the capillary is metallised from the inside, this metallic layer can be used as a heating resistor.
  • the invention consists of three complementary or successive parts - a valve, a flow regulator and a metering device with valve or flow regulator.
  • An important component of the invention is also the working medium, which can be defined by its physical properties.
  • the entire device, in particular the valve, is intended as one on the body of a portable or suitable for this use.
  • the proposed also flow regulator is not a mere combination of valve and flow meter. It is a new component that cleverly uses a synergy effect.
  • the energy required to open the valve is used to make a thermal flow measurement.
  • a flow measurement opens the valve.
  • the structure of the flow regulator is hardly distinguishable from the structure of a thermal flow meter.
  • the main design difference is that the flow regulator also represents a throttle, which is not the case with a normal flow meter. The flow must be throttled, as there is no measurable movement of the medium in the case of the low flow rates unless the flow cross-section is significantly reduced.
  • the entire working medium flowing through is heated for the measurement.
  • thermo-rheological flow regulator in the metering device with the working medium for indirect metering additionally allows the basal rate to be used to establish the throttle characteristics of the overall system.
  • the working medium is functionally determined by its temperature-dependent change in viscosity and by its temperature stability up to the heating temperature.
  • the list of possible substances usually includes organic substances.
  • Most material data for this application are not publicly available. The accessible material data often refers to other temperature ranges. Specialists in the field of chemistry can, however, look for corresponding data for oils, fats and the like. To fall back on.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • General Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Mechanical Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne une valve thermo-rhéologique destinée à un milieu sous pression (7) dont la viscosité dépend de la température, comprenant un segment de conduite servant à véhiculer le milieu et un système de chauffage (3, 4) équipé d'au moins un élément chauffant (3) servant à chauffer au moins une partie (2) du segment de conduite (5) et du milieu véhiculé dans celui-ci, caractérisée en ce que les dimensions du segment de conduite (2, 5), en particulier sa longueur et/ou sa section transversale, et la viscosité du milieu (7) dépendante de la température sont choisies de manière adaptée l'une en fonction des autres de telle façon que, dans un premier état de fonctionnement de la valve à une première température de service, de préférence dans un état du segment de conduite (2) non chauffé par l'élément chauffant (3), il s'établit une résistance fluidique de la valve telle qu'elle génère dans le segment de conduite, à une différence de pression prédéfinie entre les extrémités de la partie de segment de conduite (2, 5), un débit de passage volumétrique du milieu allant de 0 µl/min à 200 µl/min, de préférence d'environ 0,02 nl/min à 20 µl/min, de la façon la plus préférentielle d'environ 0,2 nl/min à 2 μl/min. L'invention concerne en outre un régulateur de débit et un dispositif doseur (1) qui comprennent la valve précitée. Une application préférée se situe dans le domaine de la technique médicale, en particulier de l'administration d'insuline à des diabétiques ou similaires.
PCT/EP2013/053804 2012-11-12 2013-02-26 Valve thermo-rhéologique, régulateur de débit et dispositif doseur Ceased WO2014072079A1 (fr)

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DE201210220558 DE102012220558A1 (de) 2012-11-12 2012-11-12 Thermo-rheologisches Ventil, Durchflussregler und Dosiervorrichtung
DE102012220558.6 2012-11-12

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Cited By (1)

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Publication number Priority date Publication date Assignee Title
CN113507948A (zh) * 2019-01-10 2021-10-15 贝朗梅尔松根股份公司 用于通过体热的输液器加热的节流件

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US4082109A (en) 1976-09-03 1978-04-04 Hughes Aircraft Company Heat pipe actuated valve
DE3311020A1 (de) 1983-03-25 1984-09-27 Hasko von Dipl.-Ing. Dr.med. 8000 München Sanden Abgabeeinrichtung zur verabreichung von fluessigkeiten
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EP1396275A1 (fr) 2002-09-09 2004-03-10 Novo Nordisk A/S Moyens d'indication visuelle pour un dispositif d'administration
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Publication number Priority date Publication date Assignee Title
CN113507948A (zh) * 2019-01-10 2021-10-15 贝朗梅尔松根股份公司 用于通过体热的输液器加热的节流件
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