CZ2000405A3 - Automated feeding device and method of using thereof - Google Patents

Abstract

Dosing device consisting of a) housing (2), b) a fluid reservoir disposed within the housing (2), this the container has an inlet port, c) a dispensing tube that is connected to the container opening so that fluid can flow, the front end of the tube is given a fluid remote from the tray and the rear end of the tray, the front end a the rear end defines an axis between each other and forward and backward direction, and d) a pump that is adapted for dosing fluid at least in the direction of the container through the tube, the device it comprises a sensor (21, 22) which changes its state at least in in one aspect with respect to a predetermined distance the object (23, 26) and the sensor (21, 22) in the sensed direction, a converter that is separated from the sensor (21,22) or is not connected, which converts at least one of the sensor states (21, 22) to an electromagnetic signal and outputs a control signal operating component of the device.

Description

Automated dosing device and method of its use

Technical field

The present invention relates to a dispensing device comprising: a) a housing, b) a liquid container which is contained within a housing, said container having one opening, c) a dispensing tube which is connected so that fluid from the opening can flow therethrough, the forward end of the tube being further away from the reservoir with respect to the fluid flow, and the rear end being closer to the reservoir with respect to the fluid flow, the forward and rearward end defining an axis extending therebetween and forward and reverse; at least in the direction from the container to the tube. The invention also relates to a method of using such a device.

BACKGROUND OF THE INVENTION

Although dispensing devices are known for use in a variety of different applications, the present invention relates in particular to injection devices for applications where the receiving object is rigid or semi-solid and where the orientation of the injection device relative to the receiving object is critical for a successful injection result. Typical applications are the administration of pharmaceutical preparations to humans or animals where orientation is important for various reasons. Depending on the nature of the preparation and the intent of treatment, the target tissue is vital for the target tissue. ······· · · · ··. ··· · ··· · correct biochemical activity, availability and absorption period. The injection site may be, for example, subcutaneous, intramuscular or intravenous tissue. Dose size is often critical, and erroneous treatment can be caused by loss of formulation due to, for example, accidental needle loosening or partial placement in the wrong tissue. On the other hand, particularly larger volumes may be deliberately placed at different depths during needle penetration, or partly in slow release tissues and partly in rapid release tissues.

These requirements can be met even when using the simplest injection equipment, such as routine hypodermic injection, if it is in the hands of an experienced surgeon who can also initiate medically relevant corrective action in case of malfunction or malfunction. More or less automated equipment has been in use for a long time and allows some trained laymen to inject in critical or urgent situations safely enough. Often such devices are for single use only. The general trend in long-term treatments is to delegate the responsibility for implementation to the patient himself, even in the case of children or disabled persons. In these cases the claims are even higher. Repeated treatment requires that the patient undergo repeated dosing, even with variable dosing, and the correct replacement of the emptied ampoules with new ones, as in the case of a cartridge pen. To avoid errors, a high degree of automation and control is required, not only at the injection stage itself, but also at critical initial or preparatory steps. A patient who is dependent on daily application also has a legitimate comfort requirement and the device that can be used uses a mechanical to place the device in to the skin and squeezes sufficiently discreet in everyday life.

In common auto-injectors are automation. Usually, the user must have the correct injection orientation relative to the lock button. Mechanical energy, such as springs, can then self-impinge into the tissue, autoinject the device, and even automatically retract the needle. Simpler systems do not necessarily provide self-span, but assume that the needle is injected by the user. Here, the devices give the user little help in orienting and locating the device relative to the body. Autoinjectors are also known which require the user to press the device against the injection site to unlock the injector. Typical examples are described in patents AU 536.551, US 4.717.384, EP 518.416 and WO 93/23110. The assistance provided by such constructions is limited and inflexible and cannot be adapted to various unforeseeable situations of use or risk situations. The release, which is initiated by a given pressure and not by a given position, further complicates the desired adjustments. In general, once the release, either intentional or unintentional, occurs, the sequence of operations will be irreversible. In addition, there is generally a high risk of buckling due to reflection and the resulting bias.

Automatic devices that are based on an electronic or electromechanical principle are also described. In addition to infusion pumps and similar injection devices for primary hospital or continuous use, where the orientation of the device is not generally critical, some patent applications, eg EP 143,859, EP293,958, DE, apply. · · · · · • · · · ♦ · · · · · · · * * * * * * *

No. 2,710,433, WO 93/02720, WO 95/24233 and WO 97/14459, as well as our pending patent applications SE 9602610-9 (US 60 / 0.021,397) and SE 9602611-7 (US 60 / 021,293), for devices that are held by the hand to direct it towards the body. Known devices utilize the principles of automation in several aspects, such as accurate and reproducible injections using electric motors, self-propelled using motors and mixing or reconstitution, cartridge identification, sample analysis, collection and manipulation of injection data, dose setting, injector orientation according to direction of gravity for proper mixing and venting, etc. Despite this diversity, automated devices of this class do not address the orientation of the device relative to the body receiving the injection and do not solve the problems associated with it.

Therefore, there is a need for an injection device that assists the user in the steps associated with the orientation of the device and in preventing or mitigating the consequences of errors or misuse resulting therefrom, which is particularly advantageous for patients who self-administer treatment. Although the present invention has a more general application, it will be described mainly with this in mind.

SUMMARY OF THE INVENTION

The main object of the present invention is to avoid the disadvantages and imperfections of the known injection devices that have been described. The narrower object is to describe an injection device that would assist the user in adjusting the correct orientation of the device relative to the injection site. Another objective is to describe • · · ·

4 equipment which is flexible and adaptable to different conditions of handling and use. Yet another objective is to prevent or limit the consequences of unintended use or misuse. Another objective is to facilitate application

Another goal is to avoid another goal being to avoid merely being to offer mechanical means are fully compatible means. facilitating the preparation into the correct target tissue by irreversible injection procedures, positioning dependencies Yet another goal of positioning, with electronic or electromechanical automatic means. Another object is to make such a device easy to operate, suitable for use by patients, or requiring only limited skill and training.

These objects are achieved by the apparatus and method as described in the accompanying claims.

Some of the above objectives can be achieved by introducing a distance sensor and a converter into the injection device to generate an electromagnetic signal from the sensor. The signal is immediately available for and is compatible with several other electronic or electromechanical automatic devices that are part of the injector, thus avoiding the use of a purely mechanical principle. The signal is obtained without pressure or high forces. The use of transformed sensor output is highly flexible and can be adapted to many user situations. If a trigger portion is used in the device, unintentional initiation can be prevented by requiring the presence of a predetermined characteristic, such as a constant or repetitive signal, or by using the signal only in a narrow sequence window. Similarly, * · · * * * * * * * * * * * * * * * * * * * * · * * * * * * * * ··· ·· · ·· ·· can prevent irreversible surgical procedures by using the sensor output to block the device, for example, to stop the injection if the device gets into an inappropriate position. For similar reasons, selectivity with respect to target tissue can be introduced into the device such that injection is only allowed at a predetermined depth of penetration. Handling errors can also be avoided by warning the user or warning the user before the given deviation tolerance limits are exceeded. All the simplifications of handling used ensure that this device is very suitable for applications where simplicity is very important, for example in the self-treatment of a patient. The principles used are compatible with most manual or automatic stages of injection initiation, execution and termination, and can be adapted, for example, to automatically enter, inject and withdraw the needle, if present. The device itself may not be more complicated than necessary with respect to other aspects, especially not when using existing parts, such as a needle cover, also for the purpose of removal.

Other objects and advantages of the invention will be apparent from the detailed description that follows.

Detailed description

As noted in the introduction, the injector described herein can be used for various purposes, either in or outside the medical field, and for any type of preparations, chemical compounds or mixtures, in any container for any purpose. Because of the reasons described, the system has a particular advantage in the case of medical dispensing equipment where 4

Most of the others described in this invention may be used to also limit design by stricter applications. For clarity will be the application.

The principles of the present invention dispense devices or systems in a broad sense. The dispensing tube may be an infusion duct or any current guiding means such as a tubing or catheter, a needle or cannula, or a needleless fluid-based system or a propellant gas spray. The material in the container should be dispensable by means of a dispensing mechanism, also referred to herein as a pump, and any material that meets these requirements can be used. Typically, the material is a liquid and preferably a liquid, including materials, acting as a liquid, such as an emulsion. These conditions apply to the final formulation, however other ingredients, especially solids, may also be present prior to the final preparation. The nature of the contents of the container should also be understood in a broad sense and include eg natural ingredients and body containers filled, although most

The present invention can help to solve special problems associated with sensitive components susceptible to degradation or denaturation under high mechanical stress, eg when exposed to shear forces. The high molecular weight compounds may be such as high molecular weight hormones such as growth hormones or prostaglandins. The present invention may also serve to solve special drug-related problems that require preparation shortly before application, eg mixing two or more components, which may also be liquids, or may contain a solid, e.g.

which is and the suspension of the fluid by which the medicaments are made artificially.

4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 44 4444444 44 44 44 44 44 in case of dissolution lyophilized powder in a solvent such as hormones or prostaglandins.

The method of administration may also vary within wide limits and may comprise continuous infusion, continuous infusion with variable flow or intermittent infusion, or repeated injections of either equal or variable doses. Especially if it is associated with automatic means in an advantageous manner, the method of application can be readily changed by modifying the software or a similar control method. For portable devices, periodic application is common. Similarly, although the dispensing device may also be useful for single dose administration, they are generally designed for periodic administration of more than one or multiple doses.

In addition to the basic dosing functions, the dosing device may advantageously include other useful functions, eg for loading the container and its contents and for performing various checks of the electronics and mechanics of both the container and the pump.

The present invention may be applied to a dispensing device in stationary or permanent arrangements. For reasons that will be explained later, the present invention is particularly advantageous for outpatient purposes, particularly for those that are autonomous with their own energy store, motor and processor, and particularly small handheld devices that are truly portable.

As mentioned in the introduction, a preferred dispensing device generally comprises at least a) a housing, b) a reservoir, c) a dispensing tube that is connected to the reservoir by flow and d) a pump that is adapted to at least dispense fluid from the reservoir to the tube.

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Housing

The housing of the device should be understood in the general sense of the word and constitutes, unless otherwise specified, a reference point for the movements as well as a reference point for the forces of the applied propulsion means to effect said movements where force acts between the housing and the moving or gripping portion. The movable parts may be part of the pump system or, for example, the parts performing mixing, self-raising, ejection or retraction of the needle, etc. The minimum performance requirement is that the housing constitutes a support or platform for the moving parts and propulsions that provide movement and forces. However, as is common practice, it is preferred that the housing forms a reservoir, at least partially covering the components, and preferably also to such an extent that only the parts to be controlled or monitored by the user are outside.

Tray

The container will be understood in a broader sense and can be implemented in many different forms, such as any tube, container, flexible bag, vial, ampoule, cartridge, syringe body, etc. The use of rigid containers that are rigid has certain advantages, at least when opening or attaching them to a mechanism that is rigid, such as vials, ampoules or syringe bodies. Advantageously, conventional materials such as glass or plastics may be used for the containers. The dispenser can have a single structure or ··· ·

44 ► · 4 «» 4 4 'consists of parts, eg when it contains an outer cover or other structure composed of several parts for closing, fastening, protection, etc. and whenever we mention the container here, we will understand any additional part present. The container may be part of the housing, eg for use in disposable injectors when the container is refillable or when the container is part of a pump system that repeatedly sucks the injection agent from an external source or channel prior to the injection itself. The container may also be separate, eg, to allow replacement in the case of disposable pre-filled containers, for simple sterilization or content or patient type, more than one may be used prior to disposal in case of alteration. , for example, in the case of mixing injections, mixing during injection, taking part of the volume from each container, or in the case of sequential injections or various substances.

The reservoir has at least one opening through which the medicament passes during the main dispensing operation of the device, either from the interior of the reservoir to the environment, e.g. when the medicament is administered to the patient, or into the reservoir in case of aspirating body fluids or in preparatory steps such as filling, stirring or a container, where the opening is to be part of the structure. It is possible, and even in many situations, it is advantageous that some operations of the device, e.g., initiation, be performed before the passage is formed, and then it is possible to meet the opening requirements by means of preparing the passage, e.g. a removable closure or part of the container that can be pierced or broken, as in the case of an arapule, bag or ··· »

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44 specially designed parts, such as through-membranes or partitions. All flow is through a single orifice, such as both passage of the drug and pressure equalization in a rigid container or dose from a container that is flexible or has a movable or deformable portion, but this does not restrict the use of additional orifices for similar use which may be identical to at least however, it may be completely different and, for example, may be adapted for other purposes, e.g., an infusion type or a movable wall or plunger type.

The container may be a single bottle, vial or bag when the dispensing device is configured to take, continuously or periodically, metered amounts for dispensing as desired. Often, and especially in conjunction with self-administration, the type of cartridge is more sophisticated and is in the form of a capsule that is the cartridge portion of a syringe type dispensing device, which may be even more sophisticated in the case of multi-chamber capsules. The capsule for this purpose may generally comprise a container having a front portion and a rear portion that define a major axis of the capsule, a spout for the specimen located at the front and at least one movable wall located at the rear, the deflection causing the specimen to move towards or is discharged by the discharge. The shape of the container and the movable wall must be mutually adapted. The container may have a substantially constant internal cross-section, with a similarly constant axis of the container, between the front and rear portions that form a generally tubular container, and preferably the cross-section is generally circular and forms a substantially cylindrical container. The movable wall should then preferably have a fixed shape, although it is also possible to have a plastic wall that fits snugly against the inner surface of the container and preferably in the shape of 0 · 0 · 00 · ·· 00 ·· · 0 · ·> 00 · 0 0 · 0 0000 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00

Dual or multi-chamber capsules are known, for example, for preparations requiring the mixing of two or more components or protosicles prior to application. The components are spaced apart by one or more walls of different known shapes, these walls dividing the container into several chambers, sometimes positioned parallel along the axis of the capsule, but usually aligned along the axis. The unification of the components can be accomplished by breaking, penetrating or opening the flap in the intermediate walls, for example by inserting a pin or needle into the front side of the capsule, through or on the rear movable wall, or by the outside of the capsule (cf. e.g. WO 93/02720). In another known design, the intermediate wall or walls are of the plunger type and flow between the chambers is achieved by moving the plunger to a portion of the coupling, wherein the inner wall has one or more enlarged portions or repetitive circumferential grooves and pads by deflecting the rear movable wall (cf. US 4.968.299 or WO 93/20868 and WO 95/11051). The chambers may contain a gas, a liquid or a solid. Typically, at least one component is liquid. Most commonly, two chambers are used in pharmaceutical applications, one containing a liquid and the other a solid that dissolves and reconstitutes during mixing.

Tube

Generally, the dispensing tube is connected to the opening of the reservoir so that fluid can pass through it and is oriented so that its front part is further away from the reservoir and the rear part is disposed. * 9 9 9

999 99 99 9 99 9 · is closer to the hopper due to flow. In its most basic form, the tube can be understood as an extension of the container opening.

In this sense, the anterior portion may be of any nature, including a connection to another tube, e.g., any conventional infusion channel. However, it is preferred that the leading end is the end of the injection channel that is configured to dispense the formulation to the target site, eg at or in the patient, and at least the outermost portion of the tube should be suitable for the purpose of dosing there. Depending on the dispensing mechanism used, the forward end may not be intended to be in direct contact with the target site, such as for liquid, powder spray or other sprays, where the forward end may be a mouth or nozzle for directing the target distance or target surface in spite of the fact that the real target is below the surface.

In other cases, the forward end is designed to penetrate the target as in the case of cannulas or conventional needles. The channel between the front end and the rear end may be curved or bent, such as in the case of flexible infusion tubes or at constant connection, although in many applications it is desirable that the tube be substantially straight, such as needles or syringes. Generally, at least the most forward-facing portion determines its output axis and forward and backward direction for flow sense. The position and direction markings will follow this rule unless otherwise stated.

Pumping mechanism

The mechanism for dispensing the medicament through the reservoir opening should in principle comprise at least one pump type that is selected for a particular purpose or because of the reservoir used. 1411144 9 9 9 9 9 9 9 9 9 9 or medicines. The pump may comprise any kind of pressure source, either mechanical or electrolytic principle, which is embedded in the container and has a suitable control fuse, such a method may be used with any type of container and any type of substance, such as for subcutaneous application of powder, as exemplified in WO 94/24263, similar is liquid spray application as exemplified in WO 94/2188, or a conventional infusion tube as exemplified in WO 88/09187. Any type of reservoir can also be used with peristaltic or centrifuge-based pumps, although positive displacement control pumps are preferred for general use, and especially those based on the operation of a separate cylinder and piston as exemplified. in US 5,480,381 for a liquid nozzle or US 4,564,630 for a manually operated needle-based device. Conventional syringe containers require a special pump system. Either the mechanism is adapted to act on whole syringes having their own plunger rods so as to be connected to said rod and axially deflect it, as disclosed in said US patent 4,978,335, which may be advantageous when it is desired to operate with syringes of many different types and sizes, or the mechanism has a piston rod that acts more or less directly on the cartridge-type piston of the cartridge, as disclosed in WO 95/26211, EP 143,895 or EP 293,958, which can be made smaller and more suitable for portable devices. Also, dual-chamber or multi-chamber cartridges may utilize similar devices for their different phases, as disclosed in the aforementioned WO 93/02720. However, the various described pumping mechanisms may comprise mechanical 44 4444

4 * 44

The means for acting on the substance or on the piston, the means such as the piston rod, can be driven by any known method, eg gas pressure, vacuum, hydraulic, spring or manual. It is advantageous to drive the pump mechanism by an electrical device, eg an electric motor, indirectly or preferably directly, inter alia, for ease of adaptation to an overall automated device.

The mechanism may advantageously comprise further parts. For example, the mechanism may include special dose security devices, e.g., by direct dose measurement, although it is generally preferred to use the pump directly or indirectly for this purpose, e.g., by monitoring axial displacement or rotation of the piston rod axis in a known manner. It is particularly preferred that the mechanism comprises a control system performing at least a portion of the aforementioned application operations, opening the cartridge or cartridges, controlling or supervising, and possibly recording the operating steps that have been performed. Such systems are known, as described in US 4,529,401, and can be designed in a variety of ways. From the point of view of the present invention, it is preferred that the control system powers and monitors at least a portion of the sensor system and processes the data it receives therefrom.

Distance sensor

In general

The principles of the invention can be used in any injector when it is desired to determine the distance or orientation between any part of it and an object. The object may be an operator, for example, disabling the operation of the equipment if properly

4 * 44 μ · ·· «

14 «444» 4 4 4 4 4 • 4 4444 4 4 4 4

4 4 4 4 4 * 4 4 44 «does not verify operator presence. The object may be part of a communication link, for example to ensure proper transmission in case of data exchange.

According to the main objective, i.e. to ensure correct positioning, the object is an injection target, eg a patient or an animal, to receive a dose or preparation of injection. In order to achieve this so that its position of the tube is precisely determined, the tube is not determined because it is preferable that the sensor be relative to the front if the front end to the housing, for example when using a flexible tube, that the sensor is mounted firmly relative to the front end to allow the user to locate the end. This arrangement may also require a conductor or other communication link to the housing in case the signal is to be used or processed by automatic means in the housing. There are advantages in using the present invention in conjunction with injection devices having a given spatial position between the forward end of the tube and the housing. The tube may still be movable with respect to the housing, for example, when withdrawing or retracting the needle, as is common in auto-injectors, or simply to access the needle or its housing or adjust the depth of penetration, but is then guided in a predetermined and predictable manner. In cases where the front end is located on the housing, the sensor may be located at said front end of the tube. The sensor is preferably mounted on the housing. The present invention has been successfully used in needle injectors where the injection site is critical for the reasons stated in the introduction. The sensor positions listed here do not prevent the sensor from moving parts, as in the case of a switch.

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The sensing direction relative to the injection target depends on the purpose of positioning the device, and the sensing direction may be completely independent of the direction of dosing or injection, e.g., in the injections in the non-injection situations mentioned above. Also, if the desired orientation of the device is related to the direction of injection, the sensed direction may be different from the direction of injection, eg, perpendicular or opposite, eg if there is a reference plane different from the surface of the injection target when working in the body cavity or úponu. In less complex situations, it is preferable that the sensed direction is at least parallel to the direction of the injection, or to the axis of the tube at its forward end as defined. The sensed direction may be used as a reference, eg, at an angle to the injection direction, particularly at an acute angle, for example, to ensure the correct starting position when the needle is inserted obliquely or laterally to the target surface, distance, albeit to a limited depth, when access to the body does not allow more perpendicular access, eg in dentistry. In most cases, it is preferable to provide the sensed direction substantially parallel to the injection direction.

Sensor type

The choice of sensor type can be influenced by many factors such as the purpose of the sensing, the nature of the object and the target, further signal processing, spatial conditions, the available energy, etc. Generally appropriate sensing principles and components are known and can be used as such or after adjustments for the purpose of the invention.

It may be desirable to use a contactless sensor that can

Detect the presence or distance of an object when the sensor is away from the object, eg to allow free positioning relative to other parts of the equipment and structures to maintain operational access in limited space to prevent sensor contamination, to protect the fragile sensor from damage, to accommodate sensing to a non-contact injector, such as a liquid nozzle or powder spray. Sensors for this purpose can be based, for example, on thermal energy, infrared or radiofrequency scanning. Conventional components may be used, such as (but not limited to) thermistors, thermoresistors, infrared receivers, etc., which may be themselves or the electronic circuits to which they are connected set to a specific target temperature, e.g. body surface temperature. When a transmitter is used, e.g., radio waves, infrared waves or ultrasound, the receiver can be set to generate a signal depending on distance, based on amplitude, frequency, phase, or target shielding. Preferred methods are capacitive or inductive sensing, which are simple, reliable and adaptable to both target type and distance. The desired signal may be derived from a change in capacity or electromagnetic field when affected by the target. All of these methods can detect the presence of an object by changing the corresponding parameter and also give the desired electromagnetic signal using existing and commercially available components. There is nothing to prevent the device from including parts to be in contact with the object, such as a sleeve or any other spacer structure to assist in stabilizing the device during injection, this structure in this case. · · · ”·: ·· = ::: • · *. *. · ♦ ·· need not be adjusted for about distances. If sensors are also to be used in providing a signal with information desirable, the aforementioned types of direct contact with the object may be either to eliminate the need for additional structure or to mediate further contact assistance.

Contact between the injector and the object is necessary when the specimen is to be introduced into the object through a duct, such as a needle, cannula, or infusion tube. As noted, in many situations, further contact between the injector and the object is desirable, eg to stabilize the device during injection, to relieve the user by placing or even attaching the device to the object, to compress or tighten the patient's skin at the injection site. caused by puncture, etc. Any of the aforementioned proximity sensors that operate non-contact can also be used in contact with the object, with or without extension members as described. However, in case of need for contact, the sensor may preferably be manufactured as a contact sensor. The mechanical contact can then be sensed, for example, as a pressure that acts between the sensor in a desired, predetermined and object-oriented position, which when parts of the method can also be adapted to react only if a certain predetermined contact pressure is applied, e.g. proper injection or as protection against the effects of reaction forces. The sensor may comprise a true pressure sensor, a piezoelectric element or a switch biased by mechanical means, such as a spring force or a spring type latch switch. Pressure sensing may not require large movements of any part of the sensor. Alternatively, the contact may be sensed as a deflection of the movable part which is caused by • 4

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relative movement between it and the object. Deflection sensing can be easily ensured and requires little force. On the other hand, the deflection can be sensed by itself, e.g. as a current induced in the coil during movement, which can additionally provide a signal corresponding to the speed. The deflection can also be sensed by the position of the movable part when it is at a critical point, which can be done by any pressure detector as mentioned, but the switch type detector may be sufficient. Any type of switch, based eg on optical detection, eg photoelectric element or infrared emitter and receiver, of the moving part in the critical position can be used. Conventional mechanical switches may be used if they have movable contact surfaces, eg standard microswitches or the application of special cases where the movable part switches or opens the contact means. For reasons of reliability, it is advantageous to use switch elements which are indirectly influenced by the switching position, eg Hall elements or tongues which are controlled by a magnet or relays which are switched by a motion-induced current, and especially those which are encapsulated. The deflection can only generate a signal at the desired end position, which is sufficient in many cases, but signals can also be generated along the path, either continuously or in several discrete positions, eg to monitor the correct use of the device or to provide adjustable distance sensing. The deflection of the movable part is usually greater than in the case of pressure sensing, about 1 mm, preferably at least 2 mm and most preferably 4 mm. Any type of sensor can be used by the metering device as an addition to those sensors that are required for further operation. However, it is advantageous to provide the tube with these parts.

structures for other purposes with additional sensing capacity, which is most easily realized by contact sensors. It is often advantageous to place the sensor in a part which is connected to the tube of the device. In the case of non-contact dispensing, such as a liquid nozzle, powder spray, other sprays, inhalers, etc., such a device often includes a guide or orientation portion for contact with the object, such as a cuff or throat aperture for more general use or adapted a particular target organ, such as a mouthpiece, an eye bath, etc., and it may be desirable to couple the sensor to such parts. Similar parts may also be used in dispensing devices with a tube for contact with the object, the sensor may advantageously be coupled, for example, including tubing, needles or cannulae. Often, a pointed tube cover is used to penetrate the object and is retracted when the tube is in use. The cover is used to protect the tube from damage or contamination, to protect the user from accidental punctures, or, for example, to hide the needle to reduce the patient's anxiety. Preferably, the sensor may be coupled to a housing such that the sensor provides a signal associated with the housing movement, and preferably that a distinct signal is received when the tube is correctly penetrated. This principle can be used in conjunction with a flexible infusion tube if a cover is also used, which is not always common since infusion tubes are often applied by an experienced doctor without the need for auxiliary devices. These advantages are best evident when the device is grasped and used for application, which is usually the case when the patient self-administers the substance, which usually requires that the tube be fixed to the housing in at least all directions except axial where it can be mobility is maintained for eg self-piercing or removal of needle protection, but in many cases the tube is also stationary in the axial direction. The present invention was preferably used in conjunction with a sensor that was coupled to the movable needle needle cover.

In all described modifications, the sensor should be in a position to obtain a detectable signal change in a situation where the critical part of the device that forms the reference point is in the desired position relative to the target object. In the absence of contact between the tube and the object by this distance, the distance that is suitable for dispensing the formulation may be either a concentrated dose to be in the form of a liquid nozzle or a dispersed dose, as in the case of a spray. The sensor may be a pressure sensor in a part that is positioned adjacent to the object in a suitable position, or a displacement sensor, for example when opening the mouth cover, or a simple front switch. For tubes that enter the object, the sensor may be a pressure sensor that is positioned to come into contact with the object when the device is at a predetermined depth of penetration, e.g., at the base of the needle or cannula, or displacement sensors for a housing as described with a signal change at a predetermined deflection of the housing, eg by a switch at a desired point.

As indicated previously, the direction of the measurement sensor may be at any desired angle, although usually in a forward direction with respect to the tube. One sensor direction may be sufficient in most applications, although multiple sensors may be used to fix the sensor position in other directions, eg two sensors to determine orientation in a given plane or three sensors to determine orientation in all three dimensions, eg at use of the device in the cavity.

Use of signal

The signal coming from the sensor should be transformed into a form that represents the data described. The electromagnetic form or should be an electromagnetic signal, the distance as it was the signal may be based on electromagnetic radiation, such as an optical signal, but preferably an electrical signal. Many suitable components have been developed for use in the form of sensors to provide such a signal output, but these sensors can also be inserted into a circuit that provides such output. Any basic, integral or separate arrangement of this type can be considered as a converter of the sensor output to an electromagnetic signal. The received or transformed electromagnetic signal is generally processed in the processor to obtain a control signal. The control signal is in turn used to control the functional or operational part of the device. The operating portion may be of any kind, although some typical examples will be given below. The control signal may be of any type, eg mechanical, optical, etc., depending on its further use, but is preferably an electrical signal.

The control signal may be used to send a message to the user, e.g., to warn or alert the user of an incorrect position before the dispensing device is activated. This message may be a sound, a tactile signal such as vibration, a visible signal in the form of a warning light, or a more complex message on a display, etc., or ·

any combination of such messages.

It is desirable that the control signal be used to control the essential functions of the device with a higher priority than the operator. The control signal can be used to activate or deactivate the device, depending on the correct positioning conditions. Activation / deactivation may be effected by an electromechanical connection, for example by means of a relay which blocks the operation of, for example, the piston rod or the pump mechanism. It is better to use this function in conjunction with a device having at least some automatic means for driving the device, eg an electric motor, the operation of which can be determined by a control signal. It is even more preferred that the apparatus further comprises a motor control processor, e.g., to ensure proper handling of the vial, initiation, timing of the process, dosing, data administration feedback, etc., wherein the electromagnetic signal can be routed to the processor to enable other functions, for example, the processor may give an engine activation control signal only when the condition of the correct positioning of the device is met, or if the above-mentioned initiation steps have been correctly performed or if the condition of correct operation has been positively verified by the control program. The existing processing unit may act as a processor between the electromechanical signal and the control signal.

Furthermore, the control signal can be used to start the device, i.e., the device. after the sensor signals trigger an automated function under predetermined distance conditions. The activation / deactivation condition just described can be used for this start function together with purely mechanical propulsion means via an electromechanical start mechanism, preferably together with an electric motor and preferably with an automation controlled by the processor in the device.

Activities that are started or shut down can be of a different nature. Preferably, at least the injection is controlled, in a multi-dose device also including mechanical or better electrical control of the emitted doses. In auto-injector devices, the needle penetration step can also be controlled preferably by controlling the injection and injection sequence, preferably with subsequent withdrawal of the needle. There are known autoinjectors that dispense the formulation also during the needle penetration phase and others that allow injection only after the needle penetration has completed, the present invention is compatible with both modes of operation. In the case of multi-chamber overflow or clutch type vials known in the art, the injection procedure may include injecting different preparations in a given sequence, eg an anesthetic, followed by the active ingredient or ingredient and then the flushing ingredient.

If the distance value is adjustable, either electronically in the processor, e.g. by selecting different electromagnetic signals from discrete or continuous outputs, or mechanically, e.g., by allowing the sensor to move relative to the housing, the functional capabilities of the instrument are further expanded. The device can be adapted to tubes with different characteristics, eg with respect to needle length, connection and design, and to different injection depths, also to tissue type, eg, subcutaneous, intravenous, fat or muscle. The device may also be adjustable to specific target site conditions, e.g., the required local penetration depth for a given tissue tip, which may be done manually by a skilled worker or automatically if the device is equipped in a known manner with means to distinguish different types of targets, e.g. depending on the feedback on the force required to enter the needle or the pressure required for injection.

It is preferred that the sensor emits different distinguishable electromagnetic signals for different distance values, again either as a continuous signal from a non-contact sensor or as a contact sensor with a movable member that emits a continuous or repeated discrete electromagnetic signal along its path. Then, more complex application procedures can be controlled by the sensor, such as dispensing programmed amounts or different components in the case of a multi-chamber device at different depths, or continuously distributing a larger volume at different intrusion depths.

Advantageously, the electromagnetic signal from the sensor can be analyzed by the processor not only with respect to absolute distance but also with respect to variations of this distance over time, giving further valuable information. When combined with a given breakthrough force or backpressure of injection, these data may indicate the nature of the object, e.g., tissue type or misuse, e.g., strike and collision instead of proper breakthrough, or a method for guiding the user to such a predetermined appropriate puncture rate.

All of the above-mentioned sensor signal applications are facilitated by the presence of at least some electromechanical means in the device, as will be explained below.

Signal processing

For full general functionality, the device should be complemented by suitable electronics to control the active elements of the sensor and to extract the electromagnetic signal from the sensor. The processor electronics should be able to at least detect the output of the sensor, either for extracting continuous or discrete data, and utilize it via a control signal, e.g., any of the above, wherein the processor should at least adapt and / or send an electromagnetic signal to the operating part. Examples of preferred signal processing will be given below.

The electromagnetic signal from the sensor may be a simple switch signal received from a switch type sensor that may be sufficient for many purposes, e.g., normal start or close commands. The quasi-continuous signal can be received, for example, from several switches, e.g. along the deflection path or mechanical pressure resistance levels. A true continuous signal can be received from many sensors, such as the non-contact types mentioned, pressure sensors, piezoelectric devices and magnet-based motion sensors. Examples of using these responses have been described in the previous section.

A simple switching signal can be used as a switch, eg in a motor switching circuit, or as an analogue but better digital signal for more complex processing for automation or control. A quasi-continuous signal from all independent circuit switches can be used similarly to allow for their differentiation or as a continuous signal at the switching pulse frequency when the switches are arranged in parallel. A true continuous signal contains even more information and can be processed in a different way than the two-valued switching signal.

Although all types of signals can be used

99 9 ·

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4

4 • 4 in a simple way, it is advantageous to use the signal in a more complex way. First, more information can be obtained from the signal. Second, the information contained in the signal can be used to compensate for random factors in the response of the apparatus to extract a more reliable processed signal. Third, earlier hardware may be mistaken for software, eg, to allow for a smaller or simpler device.

Therefore, the sensor output can be monitored, for example, for an amplitude time course, directly or indirectly, and this functional dependency is processed before an action based on this function is performed. This variable may be the distance that forms the signal as a function of distance, eg when the movement itself is to be monitored, but the variable is better time, which creates the time dependence of the signal. The obtained function can be processed as continuous, but it is preferred that the values are sampled from the output of the device, which may be performed irregularly, but preferably at regular time intervals at a certain frequency. Sampling may be performed in any known manner. The sampling may be digital such that the amplitude is compared to a reference level and is set to either binary 1 or binary 0 depending on whether the amplitude is above or below the reference level, which may vary but preferably is fixed. For extracting more information from the data, it is preferred, inter alia, to use an analog sampling method in which the function of the absolute value of the amplitude is repeatedly recorded. The analog value can be processed by a digital processor. The signal may be filtered in a known manner to remove a certain frequency range or noise.

• 4 ·

Function values can be stored and processed at any time, but in general, real time processing is preferred in most applications, but this also requires some storage of the values to be processed at the same time. It is preferred that the processing comprises at least two, preferably three, and even more functional values at a time. The processing may be carried out in any known analog or digital processor, preferably one that includes a standard microprocessor or specific integrated circuit application.

The processing may be intended to extract any time function position information for recording or instant action for any purpose described in the examples. However, it is preferred that the processing additionally serves to modify the signal from the device to be more reliable for its intended purpose, some of which will be exemplified in the examples.

The processor can perform analogy to the physical damping of the device or the movement of the sensor. In the rest position of the device, this can be achieved, for example, by filtering some frequencies, averaging movements around the equilibrium point, or extrapolating the regression curve. In discrete rest positions, a similar result may be based on a delayed or repeated query whether the amplitude corresponds to a position corresponding to a stable rest position.

The processing may calibrate the device, eg by recording the instantaneous output under defined conditions, either statically, eg in discrete positions, or dynamically for continuous movements and / or response of the device to various interventions, eg with respect to changes in control conditions, ambient conditions, etc. .

· »· · · · ·

. · · · · ♦ ♦ ». , · ····

........

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The processing may create conditions to provide physical hysteresis of the movement of the device, eg by requiring a certain degree of amplitude change to transmit a signal that corresponds to a change of one position to another in order to reduce, for example, frequent flipping around the equilibrium position. Regardless of which signal processing principles apply, there are some particularly valuable options in this context. Unlike the mechanical principle, signal processing should provide some possibility of repeating the operation, eg after the operating sequence has started, perhaps depending on the sensor output, it should be possible to act on the sequence by a predetermined signal from the sensor. For example, if a sensor signal indicates that the position is no longer suitable for an immediate operating phase such as puncture or injection, the device should at least be able to give a control signal to alert the user and allow the user to repair, and preferably recalculate or reprogramming a processor to deliver a complementary dose or an extra dose, e.g., depending on the delay time at subsequent injection.

Appropriate use of the repetition option would also benefit from the hysteresis described above, eg the device should allow some and by deactivating or activating the property the signal processing as in the examples above, but also by sensor design, eg by providing the switching sensor with contact surfaces of desired length or provide a mechanical bias in the bistable switch to provide a certain area of inactivity within the specified pressure range.

Preferably, the device is also equipped with an automatic activation between Run. This tolerance and the return means to be provided has been mentioned. • 4444 4 4 »

4 4 4 4 4 and a sensor sensitive to the sensor output only in a predetermined window of the operating sequence, eg after successful identification of the ampoule, mixing, venting, delay, dose setting, etc. These means may also be sensitive to conditions, such as rate of change, stable change or repetition of the change, distinction between suitable and inappropriate conditions, inadvertent or accidental triggering.

Hardware

The sensor system of the present invention may also provide advantages in fully manual control of the metering device or in mechanically controlled devices, e.g., in manually loaded spring systems, where the sensor signal is used for alarm, indication and signaling. As indicated, it is preferred that the sensor signal be used in automated devices, and for this purpose the device should include an exciter that includes at least one electromechanical device with energy storage means, such as a battery, for propulsion. The connection between the sensor and the electromechanical device can be of various kinds. The sensor signal can be a simple switch that directly acts on the electromechanical device. In order to enable the accompanying functions described, more complex connections may be required, either special discrete component circuits or a better general processor such as a multipurpose microprocessor, or application of a specific integrated circuit.

The electromechanical device may be any device,

0000

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0

0 0 0 0 0 which can be controlled by electrical mechanical forces. The electromechanical or solenoid or preferably electrical at least one pumping mechanism has been controlled or influenced by electromechanical means. It is preferable that other functions be controlled by electrical means, such as a puncturing means and possibly a needle withdrawal means. For the sake of simplicity, these additional means need not necessarily be controlled electromechanically, they may be controlled mechanically, e.g. by a spring, manually or by a simple electromechanical means. However, for reasons of high flexibility, at least electromechanical release means such as solenoids and preferably a separate electric motor should be used for these additional functions.

the means for invoking the device may be a relay motor. It is preferred that

BRIEF DESCRIPTION OF THE DRAWINGS

1A and 1B show schematically a preferred device with a sensor in the form of a movable needle cover; FIGS. 1A and 1B show the cover in the pulled out and out position respectively. overcast.

Figures 2A, 2B and 2C schematically show a circuit board with switches that are connected to two different needle guards.

are two views of a preferred embodiment using the principles described in connection

3A and 3B of the needle shield shown in FIG. 2.

4A-4D show alternative switching elements.

schematically shown ····

DETAILED DESCRIPTION OF THE INVENTION

Giant. 1A and 1B schematically illustrate a preferred sensor device comprising a needle cover. The device is generally referred to as 1 and comprises a housing 2, a syringe-type cartridge 3 having a injection needle at its front end and a piston 5 inserted at its rear end. The piston is connected to a plunger which is driven by an electric motor 7. Via needle 4 a housing 8, coaxial to the needle, is disposed axially deflectable along the needle so that the needle can pass through the opening 9 in the front of the housing. The structure 10 is connected to or is an integral part of the housing 10, which structure 10 is adapted to operate the switch 11 on the housing 2. In Fig. 1A, the housing 8 is in its outermost front position, covering the entire needle 4 and 1B shows the front of the device 1 in contact with the object 1, this situation causes the cover to retract, the needle has penetrated the object, and the structure 10 is in the vicinity of the switch 11.

advantageously, the cover may be biased to its extreme front position in Fig. 1, eg by means of a spring (not shown). Preferably, the structure 10 may be a small magnet that is embedded in the plastic housing and the switch 11 may be a component that opens and closes depending on the magnetic field, such as a reed switch element that generates a two-position signal in the circuit. Obviously, the described arrangement creates a proximity sensor by changing the state when the cover is moved by the object 12 to the rear position in which the switch 11 acts on the structure 10 ♦ The switch 11 is fixed with respect to the housing 2 and the needle • 999 • 9 99

9 «

9

9 • 9 · 9 · 9 · 9999 9 9

9 9 9 »99 4 99 and therefore the sensed distance also bears relation to these parts, in this case a given needle penetration depth. It is also obvious that the state change is basically converted into an electromagnetic signal, here in the form of a switch by means of a line 13. The signal may be indicated by the dotted line 14 of the motor 7, but in a more complex way be used by itself, as for example, for direct activation, it is preferable to process the signal by somehow, as shown by the solid line that leads to a separate processor 15. The processor 15 may be any processor that was mentioned earlier in the specifications of the above tasks. It is preferred that the device be at least partially automated, e.g.

stack initiation and monitoring procedures, self-checking and message-sending procedures, etc., and for the same processor to be used for at least some of these procedures and for functions such as simple steady-state checking to avoid sudden start and / or positive acknowledgment of any mentioned functions. The first output control signal 16, the activation motor 7, and the second control signal 17 that control the message on the display unit 18 are shown. The processor 15 may be arranged to directly trigger the control signals after receiving the correct electromagnetic signal 13 or better wait for the manual control control signal 19. from the button and thus the electromagnetic signal 13 is used only as a signal to switch the device on before starting manually. In both examples, it is preferred that the processor 15 continues along the monitoring line 13 to detect any significant deviation from the position where the control signal change is transmitted, e.g., by sending a warning message by the line 17, and it is possible to interrupt the activation signal 16

9,999 9 · 9 ·· · ·

9 · 9 9 9 ···· · · 9 9 9 9 · · ·

9 9 9 9 9999 9 9 · · ·

999 99 9,999

99999 99 9 99 99 for engine.

2A, 2B and 2C schematically illustrate a circuit board with switches that operate with two different needle guards. The circuit board 20 is used in a dispensing device of the general type described in FIG. 1 and may include (not shown) circuits and components for any of the purposes described herein. We will now be interested in the fact that there are first and second switches 21 and 22 on the board that form part of the sensor system together with the two different needle shields 23 and 26 shown in Figs. 2C. The needle cover 23 of Fig. 2B has an upper longer arm 24 by which it communicates with the first switch 21 and a lower shorter arm communicating with the second switch 22. When the needle cover 23 is correctly seated in the dispensing device, the longer arm 24 is in such a position. position that constantly closes the first switch 21 regardless of whether the cover moves forward or backward, thereby allowing the electronics to verify the presence and proper installation of the cover as well as the type of cover installed. The shorter arm 25 is positioned to close the second switch 22 only when the needle cover has been moved to the rearward position, while in the forward position of the cover the switch is not affected. Obviously, in the situation of FIG. 2B, the first switch 21 functions as a control, while the second switch functions as part of the sensor system. The needle cover 26 shown in Fig. 2C is similar to that of Fig. 2B except that there is an upper arm 27 that communicates with the first switch 21, a shorter arm and a lower arm 28 that cooperates with the second switch 22. longer. Obviously, in the situation of FIG. 2C, the second switch functions as a control and the first switch 21 functions as part of the sensor system. It is also apparent that the arrangement described in FIG. needles, 23 or 24, were used to allow different behavior of the device depending on the housing used. A preferred use of this option is to automatically dispense the fluid when the needle cover is moved to the rear position without the need for further action when one of the needle cover types 23 or 26 is installed, while using another needle cover the device is only ready to operate when the needle cover is moved to the rear position such that the next operation is merely to initiate the dispensing, preferably by actuation by the hand button. Although the needle shields 23 and 26 have been described as different parts, it is also possible to equip one needle shield with two different groups of arms that can optionally be used to switch switches, e.g., by having the arm structures of Figs. 2C places the needle cover on opposite sides and the conversion between these arrangements is performed by rotating the needle cover 180 degrees.

Figures 3A and 3B show two views of a preferred embodiment of the needle cover described with Figure 2. As best shown in Figure 3B, the needle cover 30 comprises a body 31 with a front opening 32 for ejecting the needle when the cover is slid. needles backwards. At the rear end there are protrusions 33 and 34 connecting the needle cover to the extended slots (not shown) on the dispensing device, this connection being facilitated by the flexible nature of the protrusions and the locking flap 335. The needle cover 30 guided by the slots can move between the front and rear positions. As best shown in FIG. 3A, the contact structure 36 is attached to the needle cover body 31. The contact structure 36 has a short arm 37 and a short arm 38. The arms 37 and 38 have the same function as the arms described in reference to FIG. 2, • ······················

····· · · · ie. the longer arm 37 constantly pushes the switch and the short arm 38 pushes the next switch in the device only when the needle cover 30 has been moved to the rear position where the appropriate length of the needle is pushed through the hole 32 outside the needle cover.

4A to 4D show schematically the switching elements that can be used in the sensor. In all the figures, the main part of the switching element is fixed to the base 40, which is attached to the housing of the dispensing device, while the part 41 is movable relative to the base 40, although the opposite case is also possible. The movable portion 41 may be a needle cover or any of the sensing portions described. The movable portion 41 can move from left to right in the figure. In Fig. 4A, the switching element comprises a bistable contact plate that switches from one state to another provided it is compressed by the movable portion 41. In Fig. 4B, the switching element 43 is permeable when the resilient conductive pad is pressed to break the conductive pattern on base £ 0. In Fig. 4C, the switching element 44 comprises a magnetic field sensitive portion, e.g., a Hall element or a reed element, and the movable portion 41 comprises a magnetic element that can cause a change in state in the switch 44. In Fig. an infrared transceiver 46 and a radiation receiver 47, which can detect a change in the received radiation caused by the presence or response of the moving part of the receiver.

Claims (58)

Patent claims 1. A dispensing device which comprises: a) a housing; b) a fluid reservoir disposed within the housing, said reservoir having an outlet opening; c) a dispensing tube which is connected to the reservoir opening so that fluid can flow therethrough; the end of the tube being spaced from the reservoir relative to the fluid flow and the rear end abutting the reservoir, the front end and the rear end defining an axis and a forward and backward direction therebetween, and a pump adapted to dispense fluid at least in that the improvement comprises, a sensor that can change the state in at least one aspect in response to a predetermined distance of the object relative to the sensor in the sensed direction, a converter that is either separated from or associated with the sensor that converts at least one of states the sensor for the electromagnetic signal and the processor that receives the electromagnetic signal and generates it signaling the operating part of the device. 2. The apparatus of claim 1, wherein said container comprises an elongated cylinder and a movable wall inserted therein, and limits the chamber between the container opening and the movable wall. Device according to claim 2, characterized in that the chamber is divided into at least two chambers by at least one intermediate wall. 4. The apparatus of claim 1 wherein the forward end of the tube is an end of the injection channel. 5. The apparatus of claim 1, wherein the front end of the tube is for intrusion into the object. 6. The device of claim 1, wherein the forward end of the tube is a needle or cannula. 7. The apparatus of claim 1, wherein the pump comprises a cylinder and a piston. 8. The apparatus of claim 1, wherein the pump is electrically driven. 9. The apparatus of claim 1, wherein the sensor can change the state at a distance from the object. 10. The apparatus of claim 9, wherein the sensor comprises a capacitive or inductive sensor element. 11. The apparatus of claim 1, wherein the sensor can change the state when in contact with an object. 12. The apparatus of claim 11, wherein the sensor comprises a pressure sensitive element. 13. The apparatus of claim 11 comprising a displacement sensitive element. 14. The apparatus of claim 11, comprising a switching element. 15. The apparatus of claim 1, wherein the processor is a signal transmission line between the sensor and the operating component. 16. The apparatus of claim 1, further comprising signal processing circuits configured to process time signal functions. 17. The apparatus of claim 16, wherein the processing performs one of the functions of physical damping, calibration, analogue to physical hysteresis, or any combination thereof. Device according to claim 1, characterized in that the device in that the sensor comprises a hand key in the sensor of the processor which is a processor and that the processor is arranged to generate a control signal only when it is activated. 19. The apparatus of claim 1, wherein the operating component includes a message device that can report to the user. 20. The apparatus of claim 19, wherein the messaging device can output a tactile signal, a visual signal, a message on the display, or a combination thereof. 21. The apparatus of claim 1 wherein the operating component comprises an electromechanical device and wherein the control signal is coupled to activate or deactivate the electromechanical device. 22. The apparatus of claim 21, wherein the electromechanical apparatus comprises a relay, an electric motor, or a combination thereof. 23. The apparatus of claim 21, wherein the electromechanical apparatus is adapted to release at least a pump. 24. The apparatus of claim 21, wherein at least the forward end of the tube is movable relative to the housing and wherein the electromechanical device is configured to drive or release the respective movement. 25. The apparatus of claim 24, wherein the induced or released movement is in a forward or reverse direction. 26. The apparatus of claim 1, wherein the sensed direction has at least one component parallel to the forward direction. 27. The apparatus of claim 26, wherein the sensed direction is substantially parallel to the forward direction. solenoid, by propulsion or • · 28. The apparatus of claim 26, wherein the sensor is positioned at a predetermined distance and in a predetermined relationship at the front end of the tube. 29. The apparatus of claim 28, wherein said relationship is a predetermined distance at the forward end of the tube or forward of the forward end of the tube, and changes in sensor condition occur without the front end of the tube entering the object. 30. The apparatus of claim 28, wherein said relationship is a predetermined distance back from the forward end of the tube when in an extreme forward position, and the sensor condition changes when the forward end of the tube enters the object. 31. The apparatus of claim 30, wherein said relationship is a predetermined distance at the forward end of the tube or forward of the forward end of the tube when the tube is in its extreme rear position, and penetration of the forward end of the tube into the object may occur. sensor at a predetermined distance from the object. 32. The apparatus of claim 28, wherein the sensor comprises a movable portion having a length at least between the front of the tube and a predetermined position, and wherein the sensor changes the state when the movable portion is swung back. 33. The apparatus of claim 32, wherein the movable portion is designed as a cover or at least a portion of a tube. 34. The apparatus of any preceding claim, wherein the sensor is positioned at a predetermined distance fixed relative to the housing. A method for orienting a dispensing device, said dispensing device comprising a) a housing, b) a fluid reservoir disposed within the housing, the reservoir having an outlet opening, c) a dispensing tube that is connected 9 9 9 9 9999 99 9 9 99 9 9 9 9 9 9 99 9 99 99 9 99 with an opening so that fluid can flow therethrough, the tube has its front portion relative to the outlet at the distal end relative to the container and the rear portion relative to the flow is near the container, the front and rear ends define an axis therebetween and a forward and reverse direction; and d) a pump adapted to dispense fluid at least in a direction away from the reservoir through a tube, characterized in that the enhancement comprises: (a) sensing the distance of a fixed or semi-solid object to the reference point of the equipment; b) generating an electromagnetic signal representing said distance (c) processing of the electromagnetic signal to generate the control signal; and d) controlling at least one operational component of the device by said control signal. 36. The method of claim 35, wherein the sensing step comprises contacting a portion of the sensor with the object. 37. The method of claim 35, wherein the sensing step comprises moving a portion of the sensor relative to the reference point. 38. The method of claim 35, wherein the reference point is the forward end of the tube. 39. The method of claim 35, wherein the reference point is fixed relative to the housing. 40. The method of claim 35, wherein the generated electromagnetic signal is substantially a switching signal or a particular transient signal, the signal varying at a predetermined distance value. 41. The method of claim 35, wherein the processing step comprises modifying the signal and / or transmitting it. 4444 4 44 4 44 4 44 4 4 · · 4444 4 4 · · · 9 9 9 9 9 99 9 99 9 9 9 «· 44 to the operating component. 42. The method of claim 35, wherein the processing step comprises the step of obtaining and processing a time function of the signal. 43. The method of claim 35, wherein the processing is analogous to physical damping, calibration, analogy to physical hysteresis, or a combination thereof. 44. The method of claim 35, wherein the processing comprises the step of generating a control signal only if the electromagnetic signal has a predetermined characteristic. 45. The method of claim 44, wherein the predetermined characteristic is a constant or repetitive signal over a period of time. 46. The method of claim 35, wherein the processing comprises the step of performing self-checking and outputting a control signal only if the result is positive. 47. The method of claim 35, wherein the processing comprises the step of changing the pilot signal if the electromagnetic signal is changed in a predetermined range. 48. The method of claim 35, wherein the processing comprises the step of generating a pilot signal only when a manually operated key is also used. 49. The method of claim 35, wherein the controlled operating component comprises a message device that issues messages to the user. 50. The method of claim 49, wherein the controlled message device may emit a tactile signal, a visual signal, a message on the display, or a message thereof. 0 0 0 0 ·· 0 0 0 0 0 0000 0 0 0 0 0 000 000 0 0000 000 00 00 0 0 · ♦ · combination. 51. The method of claim 35, wherein the controlled operating component comprises an electromechanical device and wherein the control signal activates or deactivates the electromechanical device. 52. The method of claim 51, wherein the electromechanical device comprises a relay, solenoid, electric motor, or combination thereof. 53. The method of claim 51, wherein at least the forward end of the tube is movably mounted relative to the housing between the rear and forward positions, and wherein the electromechanical device is configured to drive or trigger movement. 54. The method of clause 53, wherein the drive or lowering is performed only when the object is near or directed to the front end of the tube. 55. The method of claim 51, wherein the electromechanical device is configured to drive or start at least a pump. 56. The method of clause 55, wherein the drive or lowering is performed only when the object is at or at the forward end of the tube. 57. A dispensing device which comprises: a) a housing; b) a fluid reservoir disposed within the housing, said reservoir having an outlet; c) a dispensing tube that is connected to the reservoir opening so that fluid may flow therethrough; the end of the tube is spaced from the reservoir relative to the fluid flow, and the rear end abuts the reservoir, the front end and the rear end define between each other an axis and a forward and reverse direction, i.e., a pump which is adapted to dispense 444 4 44 4 ···· ··· * ·> ··· 4 4 4 · 4 4 ·· 44444 * 4 44 · 44 44 4 4444 The fluid at least in the direction from the reservoir through the tube, characterized in that the improvement comprises, a needle disposed at the front end of the tube, a needle cover which is located at least in the axial direction of the needle which can be deflected along the path essentially axial to the needle. a sensor that changes its state in at least one aspect with respect to the presence of the needle cover at a predetermined position along said path, a converter that is separate from or associated with the sensor that converts at least one of the sensor states into an electromagnetic signal. 58. The dispensing device of claim 57 having any of the features of claims 1 to 56.