WO2002087673A1

WO2002087673A1 - Aerosol dosing device

Info

Publication number: WO2002087673A1
Application number: PCT/EP2001/004631
Authority: WO
Inventors: Markus Fritz; Paul Safarik
Original assignee: Messer Austria Gmbh
Priority date: 2001-04-25
Filing date: 2001-04-25
Publication date: 2002-11-07

Abstract

The device (1) for controlled dosing of an aerosol contains a holder (6) for an aerosol bottle (8) and an actuation unit (10, 11) preferably for controlled or automatic actuation of the valve of the aerosol bottle (8). The device is advantageously used in a respirator system.

Description

Aerosoldosiergerät

The invention relates to a device and a method for metering an aerosol and uses of the device.

Devices for metering a gas into a breathing gas are known. For example, WO 98/31282 (internal name TMG 2028/67) describes a gas supply system for ventilated or spontaneously breathing patients, in which one or more gases (e.g. NO, oxygen) are controlled by means of a controller (program control, sensor control or combined program / Sensor control) are metered into the breathing gas unevenly (continuously or discontinuously).

Up to now, the dosage of solid or liquid medication for inhalation has been done manually. Manually operated inhalation devices are e.g. B. described in US 5,485,827.

In order to provide patients with any kind of breathing aid (e.g. intensive care ventilators, CPAP, VPAP ventilators, home ventilators, inhalation devices, nebulizers, oxygen treatment devices) it is necessary to provide the best possible supply of solid or liquid medication strictly adhere to the dosage interval of the medication.

The invention is therefore based on the object of providing a device which makes it possible to meter solid and liquid medicaments, in particular aerosols, into a breathing gas from humans or mammals, the metered amount being adhered to exactly.

The object was achieved by a device with the features described in claim 1. The device for metering an aerosol contains a controllable valve and an aerosol source or a means for non-manual actuation of the valve of an aerosol container or an aerosol bottle. The means for the non-manual actuation of the valve is usually a drive unit, for example a motor with an eccentric for exerting a lifting movement on the body of the aerosol container in order to open the conventional container valve.

The device is used in particular for metering a medical aerosol or an aerosol which contains a medicament or a pharmacologically active ingredient. The medical aerosols are generally administered for inhalation in humans or mammals.

An aerosol source is an agent that contains the components (substances) required to produce an aerosol. An aerosol source is usually a container that contains aerosol-forming substances and a propellant. The blowing agent, e.g. compressed gas, can also be provided outside the container. The term aerosol source encompasses aerosol containers and in particular aerosol bottles.

The device usually contains a device for receiving an aerosol container such as an aerosol bottle, also called a spray bottle. The aerosol bottle is usually connected to a connector (dosing adapter), the z. B. leads into a breathing tube. The device is e.g. used with a ventilator or a device to help breathing (e.g. inhalation mask). The device can, for example, also be used directly on the nose without a ventilation hose (e.g. as a handheld device for controlled aerosol metering). The metering mechanism, in particular the drive unit, is preferably connected to a controller.

Aerosol bottles (spray bottles) with a solid or liquid medication for inhalation are available as commercially available products. Solid medication or solid components of the medicament generally lie as very fine particles in front. Basically, aerosol bottles are pressure cans that contain a propellant and the medication. The blowing agent is usually a gas or a volatile substance. The aerosol bottle generally includes an opening at one end with a shut-off valve that opens when depressed (as with a conventional spray bottle). Aerosol bottles are e.g. B. aluminum container, in particular with a height in the range of 2 to 10 cm with a diameter in the range of 1 to 5 cm. Commercial aerosol bottles with medication, in particular asthma agents, are e.g. B. Sultanol® (Glaxo), Becotide® (Glaxo), Bedodual® (Boehringer-Ingelheim). The aerosol bottles are usually upside down, i.e. with the valve downwards. aligned, arranged in the device. Medical aerosol bottles are usually designed so that when the valve is actuated, a defined amount of aerosol is dispensed in one spray, regardless of the time a valve is actuated. With "normal" spray bottles, the amount of aerosol dispensed depends on the time the valve is actuated.

The device according to the invention can be used both with normal spray bottles and with medical aerosol bottles.

The device for receiving an aerosol bottle, hereinafter called holder, consists, for. B. from a cylindrical sleeve. The holder is e.g. B. firmly but releasably connected via a bracket to the dosing adapter. The bracket is on the dosing adapter z. B. clamped. The connection of the bracket and dosing adapter can e.g. B. also done via a screw. By appropriate shaping of the holder, the bracket can be omitted. The aerosol bottle is usually inserted with the valve down into the holder so that the valve outlet is seated on a connection of the connector. The aerosol bottle is therefore connected to the connector via the valve. The aerosol bottle body is generally arranged to be movable in the holder, in particular in the cylindrical sleeve, in the direction of the longitudinal axis of the aerosol bottle. In a preferred embodiment, the aerosol bottle is in the Holder with the valve outlet on the connection piece (dosing adapter) and the valve of the aerosol bottle is actuated by depressing the aerosol bottle body.

When used with a ventilation or breathing gas hose, the connection piece is advantageously a tube part with three legs or connections (a T-piece). The connection for the aerosol bottle is preferably arranged perpendicular to a straight piece of pipe with the two other connections. The connection for the valve of the aerosol bottle is advantageously equipped with a sealing element.

In an alternative device for aerosol metering, the valve of the aerosol container, which is usually present, is not used for metering the aerosol, but a controllable valve (for example a solenoid valve or pneumatic valve) arranged in front of the aerosol container valve outlet or an aerosol container outlet is used. For this purpose, the aerosol container valve is opened continuously or during the metering operation and the aerosol delivery or metering is carried out by the additional controllable valve. The device consists, for example, of a receiving unit or holder for the aerosol container, a connection for the aerosol container valve outlet to a line or a path for the aerosol, a mechanism for opening the aerosol container valve (for example a device for clamping the aerosol container with the opening pressed down Valve or a holder with a means for keeping the aerosol container valve open

The device according to the invention can also be designed as a hand-held device. The hand-held device is then used, for example, for the direct administration of an aerosol (that is to say generally without a ventilation hose) to the patient with an exact, in particular controlled, dosage. The connector (dosing adapter) has z. B. only a valve connection and an outlet opening or outlet nozzle. The connection piece (dosing adapter) for ventilation tubes is commercially available in several designs (e.g. AeroVent® HC or AeroChamber® HC from Trudell Medical International; London, Ontario, Canada). One version of the dosing adapter is suitable for connecting ventilation tubes of 22 mm in diameter to the second leg and has a suitable connection option for the valve of an aerosol bottle on the third leg, the spray shape being advantageously directed in one direction by the internal shape of the connection. Another version of the dosing adapter also contains a chamber in which the aerosol spray is mixed with the breathing gas (e.g. AeroVent® from Trudell).

The device contains a drive unit or non-manual actuation unit which serves to move the aerosol bottle body and / or to actuate the valve. The drive unit works e.g. B. mechanical, electromechanical, pneumatic or hydraulic or combined as mechanical / electromechanical, mechanical / pneumatic, mechanical / hydraulic, electromechanical / pneumatic, electromechanical / hydraulic, pneumatic / hydraulic.

The aerosol bottle body is advantageously depressed with the aid of the drive unit, so that the valve opens. The connection of the connector thus forms a fixed point on which the valve outlet rests. The valve is opened by depressing the aerosol bottle body. The valve can also be actuated by direct action of the drive unit on the valve or by moving the connecting piece against a fixed aerosol bottle body

The drive unit is, for example, a mechanical, electromechanical hydraulic or pneumatic device, in particular a pressure device such as a pressure cylinder, or an electric motor with mechanics. The drive unit is advantageously formed by a motor with an eccentric (z. B. eccentric disc), the z. B. depending on its position on the floor of the Aerosol bottle works. As a motor of the drive unit, for. B. solenoids and advantageously electric motors such as stepper motors or preferably servomotors. Pneumatically driven motors can also be used. The drive unit is advantageously connected to a control unit which controls and monitors the movement of the drive unit and thus the metering of the aerosol.

A control unit is advantageously connected to several aerosol dosing devices, for example dosing several medications. Depending on the application, the combination of one or more aerosol metering devices and one or more gas metering devices (for metering a medical gas or therapeutic gas, for example NO-containing gas) in a system such as a ventilation system can be very advantageous. In such a case, the metering devices are advantageously connected directly or indirectly to a control unit, as a result of which the interaction between the various metering devices can be better controlled.

The control unit works time-controlled, sequence-controlled, program-controlled or with a combined control mode (e.g. time-controlled and sequence-controlled; time-controlled and program-controlled; sequence-controlled and program-controlled; time-controlled, sequence-controlled and program-controlled). The control unit can contain a clock, so that the metering can also be time-controlled. The control is advantageously carried out using software. The triggering of the aerosol metering takes place, for. B. sensor-controlled, time-controlled or manual.

The device (the device) can perform the aerosol dosing during all phases of the ventilation cycle (inspiratory, expiratory, plateau phase, pause phase), the desired phase can be selected on the device. The aerosol dosage is preferably synchronized with the ventilation cycles and is triggered by inspiration. This means that the aerosol is only dosed during the phases of inhalation (inspiration). No aerosol metering takes place during exhalation. One on the breathing cycles Synchronized aerosol dosing is achieved by triggering with the help of a sensor. Based on sensor measurements, the breathing cycle, e.g. B. the beginning of inspiration or the beginning and end of inspiration, recognized by a control unit. The inspiration-triggered aerosol metering generally takes place like an inspiration-triggered gas metering, which is described, for example, in EP 413 555 A1, US 4,928,684, US 4,971,049 and US 5 195 528 and to which reference is hereby made. Analogous to inspiration-triggered aerosol metering, expiration-triggered aerosol metering or triggering for each phase of the breathing cycle and possibly gas metering can be carried out.

The aerosol metering is carried out continuously (e.g. with a fixed amount or concentration of the metered aerosol per inspiration or breathing cycle over the entire operating time or ventilation time) or discontinuously (e.g. with metering pauses), preferably a) program-controlled (e.g. Time program), b) sensor-controlled or c) with a combined program control and sensor control.

The control unit (e.g. microprocessor, computer control) receives e.g. B. the measurement signal of the sensor for triggering the gas metering and preferably determines on the basis of a program and / or sensor control whether the aerosol is metered, over what time period (pulse width tj) and what number

of metering (n-,: number of pulses) the metering of the gas i takes place. This type of aerosol metering is called pulse-modulated aerosol metering. The duration tm _a x of the inspiration or the beginning and end of the inspiration is advantageously determined by means of a sensor. The pulse width tj is less than or equal to the time period t _max . The values of the pulse width, pulse height and number of impulses within one breath (inspiration) can be preset or variable. The dosage of the aerosol is advantageously controlled, for. B. analogous to that described in WO 98/31282 (internal name TMG 2028/67), to which reference is hereby made. On the device, for. For example, a dosing sequence and, if necessary, a dosing interval have been entered (e.g. a spray should be dosed every 50 breaths). The device detects and then preferably registers the patient's ventilation cycles, after the end of the dosing pause (number of breathing cycles without aerosol dosing) a spray is metered. The device can be used for one or more sprays per breathing cycle, especially per inspiration. The duration of the sprays can be changed or adjusted if necessary. The controller will advantageously be designed so that the dosing breaks, the number of sprays and / or the dosing interval z. B. can be varied via a program during ventilation. The amount of aerosol or active ingredient administered during ventilation by aerosol metering is advantageously detected and displayed by the device. The amount of aerosol or active ingredient administered can be either indirect, e.g. B. from the number of sprays, or directly, for. B. with the help of a sensor such as an optical (z. B. photometric) or acoustic (z. B. microphone to detect the number and length of the sprays). The aerosol metering process is advantageously monitored with the aid of the sensor or additional sensors. With the aid of the sensor or additional sensors, an alarm unit is advantageously set up, which in particular draws attention to dosing errors. The sensor or sensors are arranged in the delivery path of the aerosol, that is, between the aerosol container outlet and the patient, for example in the ventilation hose of a ventilation system in the specified range or in the metering adapter.

The device for metering an aerosol is advantageously used in combination with a device for metering gases, e.g. B. used in a respiratory system. Suitable devices for gas metering are described in WO 98/31282 (internal name TMG 2028/67), to which reference is hereby made. One or more devices for metering an aerosol can be used in a ventilation system without or in combination with a device for gas metering. The device (device) for metering an aerosol preferably has the following features:

The ventilation cycles are detected, for. B. by measuring pressure or gas volume flow, acoustically or is detected by a ventilator via a signal line. A trigger level can be set on the device to identify the inspiratory phase. A dosing interval can be entered on the device. During operation, the number of ventilation cycles until the next dose is displayed on the device. The content of the aerosol bottle is entered on the device. This enables the device to show how many sprays with the bottle content are still possible. Before the content of the aerosol bottle is used up, the device alerts and advises to change the aerosol bottle. The attachment of the device is designed so that it can be attached to various types or designs of dosing adapters. The recognized ventilation cycle or inspiratory cycle is advantageously displayed on the device. The mechanics of the drive unit and the holder are preferably designed so that different aerosol bottle sizes can be used. In order to mechanically fix the device (dosing unit), a holding mechanism is advantageously attached to the dosing unit. On the device z. B. provided a way to attach an articulated arm. If the aerosol bottle does not make any movements when the drive unit is activated (because there is an error), this is recognized by the device and an error message is issued. After each spray it is checked whether the aerosol bottle has returned to its original position. If this is not the case, an error message is issued.

The invention is explained with reference to the drawing.

Fig. 1 shows a schematic sectional view of the device.

Fig. 2 shows an example of the arrangement of the device in a ventilation system. 3 and 4 show examples of metering adapters for connection

Beatmungsschiäuche.

Fig. 5 shows the device, held by an articulated arm.

The device 1 shown in Fig. 1 with holder 6 and bracket 15 attached thereto, aerosol bottle 8 with valve outlet 12, drive unit with motor 10 (e.g. electric motor, magnetic, pneumatic or hydraulic drive) and drive mechanism (eccentric disc 11). The valve outlet 12 sits on the connecting piece 13 of the metering adapter 5 (fixed point). The mechanical unit, in particular the eccentric disc 11, presses the aerosol bottle 8 against the metering adapter 5, more precisely against the seat of the connecting piece 13, which triggers the spray. The eccentric disc 11 is then adjusted so that the aerosol bottle 8 returns to its starting position, whereby the spray is ended and the device 1 is ready for the next spray.

2 shows the device 1 as part of a ventilation system. The ventilation system contains the ventilation device 4, the ventilation tubes 3 and the device 1 with a metering adapter 5. The metering adapter 5 is arranged between the ventilation tubes 3 (inspiration line). The device 1 is connected to a control unit 2, which is part of the device and controls the metering processes. A sensor 7 is advantageously arranged on the ventilation hose 3 in the region of the aerosol delivery path (between device 1 and patient 14). The sensor 7 is preferably connected to the control unit 2. The sensor 7 can have different functions, e.g. the qualitative or quantitative recording of the amount of aerosol delivered (e.g. photometric cell) and / or the monitoring of the aerosol dosage. The sensor 7 can be part of an alarm unit that draws attention to an error. The control device 2 is preferably a handheld device.

Fig. 3 shows a dosing adapter 5 with the connector 3 for the aerosol bottle. The dosing adapter is for connection to a Ventilation hose provided. The connecting piece 13 leads into an angled or curved channel, so that the aerosol can be released in the flow direction of the breathing gas.

4 shows a common metering adapter 5 with a chamber for mixing aerosol and breathing gas. The chamber is made up of a bellows, which consists of a film tube with a supporting wire spiral.

5 illustrates the mounting of the device 1 by means of an articulated arm 16.

Reference numerals:

Claims

claims

1. Device (1) for metering an aerosol, containing a controllable valve and an aerosol source (8) or a means for non-manual actuation of the valve of an aerosol container (8).

2. Device according to claim 1, characterized in that the means for non-manual actuation of the valve a mechanical, electromechanical, pneumatic, hydraulic, mechanical / electromechanical, mechanical / pneumatic, mechanical / hydraulic, electromechanical / pneumatic, electromechanical / hydraulic or pneumatic / hydraulic contains working drive unit.

3. Apparatus according to claim 2, characterized in that the drive unit has a motor (10) and an eccentric (11).

4. Device according to one of claims 1 to 3, characterized in that the device (1) has a control unit (2) or is connected to a control unit (2).

5. Device according to one of claims 1 to 4, characterized in that the aerosol is a medicament or contains and the device is connected to a breathing tube of a ventilation system, the dosage of the aerosol being carried out in the breathing gas of a human or mammal.

6. Device according to one of claims 1 to 5, characterized in that the device has a drive unit which actuates the valve of the aerosol container (8) for metering the aerosol by moving the body of the aerosol container (8).

7. Device according to one of claims 1 to 6, characterized in that the device or a control unit connected to the device one Contains time control, program control, sensor control or a combined program and sensor control or a combined program, time and sensor control for metering the aerosol.

8. Device according to one of claims 1 to 7, characterized in that a trigger device is present in or outside the device, which is used for inspiration-synchronized metering of the aerosol, or that a device for detecting the breathing cycles is present in or outside the device, dosing synchronized for a ventilation cycle.

9. Device according to one of claims 1 to 8, characterized in that the device contains a holding arm (16).

10. Device according to one of claims 1 to 9, characterized in that the device has a sensor or is connected to a sensor which is arranged in the aerosol dispensing path and for detecting the amount of aerosol dispensed during metering, for monitoring the aerosol metering or as part of a Warning device or alarm device is used.

11. The method for exact dosing of an aerosol, characterized in that with the aid of a device according to one of claims 1 to 10, an aerosol is dispensed from a container (8) by controlled and / or automatic actuation of the container valve or an additional valve.

12. The method according to claim 11, characterized in that the container (8) is a spray bottle and the actuation of the container valve is carried out by a drive unit.

13. The method according to claim 11 or 12, characterized in that the metering of the aerosol is time, program, sensor or program / sensor controlled or program / time / sensor controlled.

14. The method according to any one of claims 11 to 13, characterized in that the dosing of the aerosol takes place partially or completely during inspiration, during expiration or during inspiration and expiration.

15. The method according to any one of claims 11 to 13, characterized in that the metering of the aerosol is inspiration-synchronized and sequence-controlled and / or pulse-modulated, expiration-synchronized and sequence-controlled and / or pulse-modulated or breathing cycle synchronized and sequence-controlled and / or pulse-modulated.

16. Use of a device according to one of claims 1 to 10 for the controlled and / or automatic metering of an aerosol for direct or indirect administration of an aerosol to a human or a mammal.

17. Use of one or more devices according to one of claims 1 to 10 in a respiratory system for humans or mammals, in a device for breathing aid in humans or mammals or for direct use on humans or mammals.

18. Use according to claim 16 or 17, characterized in that one or more of the devices for metering an aerosol are used in combination with one or more gas metering units for a gaseous medicament or therapeutic gas.

19. Use of a device according to one of claims 1 to 10 in ventilated or spontaneously breathing patients.

20. Use of a device according to one of claims 1 to 10 as a hand-held device for direct use on the patient.

21. Use of one of claims 15 to 18, characterized in that the triggering of the dosage of the aerosol is carried out manually, automatically or semi-automatically.

22. Use of a device according to one of claims 1 to 10 in combination with at least one device for gas metering.