EA005024B1 - Liquid delivery device and method for operating an ejecting device - Google Patents

Abstract

1. A device for ejecting a liquid stream towards an eye, the stream moving from a proximal position towards a distal position, the device comprising a) a housing, b) a container for the liquid, c) at least one opening arranged for ejection of the stream and being in fluid communication with the container, d) a pump mechanism operable to deliver at least part of the liquid from the container through the opening to form the stream and e) an eyecup with a contact surface arranged for contact with the eye or its facial surroundings, characterized in the improvement comprising that the eyecup is arranged movable with respect to the opening or housing between at least two positions i) an active position with said eyecup contact surface at a defined safety distance to the opening and ii) a rest position with the eye cup contact surface at a position more proximal than in the active position and that a sensor is arranged to allow discrimination between the positions. 2. The device of claim 1, characterized in that the opening is arranged fixed with respect to the housing when moving the eyecup. 3. The device of claim 1, characterized in the container is removably attached to the housing. 4. The device of claim 1, characterized in that a plurality of single-dose containers are connected and arranged to be moved sequentially into an operative position relative the pump mechanism. 5. The device of claim 1, characterized in that the eyecup is-arranged to allow movement to at least one further position farther away from the housing or opening than in the active position. 6. The device of claim 1, characterized in that the eyecup can be entirely removable from the housing. 7. The device of claim 1, characterized in that the eyecup is arranged to move with a translational movement. 8. The device of claim 1, characterized in that the eyecup is arranged to be moved with a rotational component. 9. The device of claim 8, characterized in that that the eyecup is connected to the housing via a hinge. 10. The device of claim 1, characterized in that the sensor system is arranged to generate at least one signal and that the device is arranged perform at least one action on the basis of the signal, directly or after processing into a control signal. 11. The device of claim 10, characterized in that the signal generation or processing comprises at least one mechanical step. 12. The device of claim 10, characterized in that the signal generation or processing comprises at least one electromagnetic step. 13. The device of claim 10, characterized in that the sensor is arranged to generate a signal representative for continuous eyecup positions. 14. The device of claim 10, characterized in that the sensor is arranged to generate a signal representative for discrete eyecup positions. 15. The device of claim 1, characterized in that the device is arranged to de liver at least one message detectable by a user on the basis of the signal. 16. The device of claim 1, characterized in that the device is arranged to per form at least one operation step of the device. 17. The device of claim 15, characterized in that the signal is used to enable or disable the pump mechanism. 18. The device of claim 15, characterized in that that the device can only be triggered when the eyecup is in the active position. 19. The device of claim 15, characterized in that the signal is used to disable, enable an initiation action for the container. 20. The device of claim 15, characterized in that the signal is used to enable or disable a device control action. 21. The device of claim 15, characterized in that the signal is used to enable or disable a device door. 22. The device of claim 1 characterized in that the eyecup is arranged movable with respect to the opening. 23. The device of claim 1 characterized in that the eyecup is arranged movable with respect to the housing. 24. A method for operating an ejection device to eject a liquid stream, the stream moving from a proximal position towards a distal position, the device comprising a) a housing, b) a container for the liquid, c) at least one opening arranged for ejection of the stream and being in fluid communication with the container, d) a pump mechanism operable to deliver at least part of the liquid from the container through the opening to form the stream and e) a part arranged to define a predetermined distance to a target and arranged movable with respect to the opening or housing between at least two positions i) an active position with said part at a defined safety distance to the opening and ii) a rest position with the part at a position more proximal than in the active position and that a sensor is arranged to allow discrimination between the positions characterized in the steps of moving the part between the active position and the rest position or vice versa, generating a signal representative for either the active position or the rest position, optionally processing the signal to obtain a control signal and using the signal or control signal to perform at least one action on the container, the opening, the pump mechanism or the part. 25. A device for ejecting a liquid stream, the stream moving from a proximal position towards a distal position, the device comprising a) a housing, b) a container for the liquid, c) at least one opening arranged for ejection of the stream and being in fluid communication with the container, d) a pump mechanism, including a pump driver able to store cocked energy for driving the pump mechanism, operable to deliver at least part of the liquid from the container through the outlet to form the stream and e) at least one activation mechanism operable, separately form the pump mechanism, to initiate the device for the liquid delivery, characterized in that the improvement comprising a driving mechanism arranged to transform manual or stored energy both i) into cocked energy of the pump driver and ii) into direct or stored energy for operation of the activation mechanism. 26. The device of claim 25, characterized in that the cocked energy at least partially is stored in one or more mechanical springs. 27. The device-of claim 25, characterized in that the driving mechanism is arranged to receive manual energy. 28. The device of claim 25, characterized in that the driving mechanism is arranged to receive stored energy. 29. The device of claim 25, characterized in that the stored energy comprises electrical energy, preferably in a battery. 30. The device of claim 25, characterized in that the driving mechanism comprises a transmission. 31. The device of claim 30, characterized in that the transmission is arranged to perform gear down to from lower to higher force. 32. The device of claim 25, characterized in that the activation mechanism is arranged to drive an indexing action in which a container is brought into operative relationship with the pump mechanism. 33. The device of claim 25, characterized in that the activation mechanism is arranged to drive an peeling in which a temporary seal is removed from the container. 34. The device of claim 33, characterized in that the peeling action comprises moving a de-sealing tool through a disc member having a plurality of containers. 35. The device of claim 34, characterized in that the peeling action includes control of presence of a temporary seal before its removal. 36. The device of claim 25, characterized in that the driving mechanism is arranged to cock stored energy for driving the activation mechanism. 37. The device of claim 25, characterized in that the driving mechanism is arranged to cock stored energy for driving the activation mechanism directly. 38. The device of claim 25, characterized in that the driving mechanism is arranged to drive the cocking and activation mechanism at least partly in sequence. 39. The device of claim 38, characterized in that at least two actions are driven by the activation mechanism and that the at least two actions are driven at least partially in sequence. 40. The device of claim 25, characterized in that the activation mechanism is arranged to drive a control step and/or an initiation step for the container or the opening. 41. The device of claim 25, characterized in that the device comprises an eyecup with a contact surface arranged for contact with the eye or its facial surroundings. 42. A method for operating an ejection device for ejecting a liquid stream, the stream moving from a proximal position towards a distal position, the device comprising a) a housing, b) a container for the liquid, c) at least one opening arranged for ejection of the stream and being in fluid communication with the container, d) a pump mechanism, including a pump driver able to store cocked energy for driving the pump mechanism, operable to deliver at least part of the liquid from the container through the outlet to form the stream and e) at least one activation mechanism operable, separately form the pump mechanism, to initiate the device for the liquid delivery, characterized in that it comprises the step of operating a driving mechanism to transform manual or stored energy both i) into cocked energy of the pump driver and ii) into direct or stored energy for operation of the activation mechanism.

Description

FIELD OF THE INVENTION

The present invention relates to devices and methods for injecting a stream of liquid, in particular in the direction of the eye, a stream of liquid passing from a proximal point in the direction of a distant point, the device comprising: a) a housing, b) a liquid container, c) at least at least one hole intended for injection of the jet and communicating with the container by means of a liquid, b) a pump mechanism that functions to deliver at least a portion of the liquid from the container through the hole for forming the stream, and e) an eyecup with a contact surface for contact with the eye or other parts of the face. The pump mechanism may comprise a pump mechanism drive capable of storing charging energy to drive the pump mechanism, and at least one initiation mechanism included to initiate the fluid delivery device may be used.

State of the art

Devices for injecting jets of liquid can have many purposes. In the medical field, typical uses include injection or infusion, treatment of body cavities, intrapulmonary delivery, or treatment of the surface of the body, such as topical treatment. These objectives of the embodiments of the present invention are used in ophthalmology and, in particular, in the treatment of eyes with liquid drugs. For convenience, unless indicated in other aspects, the invention will be described in this application, although embodiments of the invention have wider application.

Devices for delivering fluids, and in particular fluids to the eye, have long been used for many purposes. Common eye baths for calming, refreshing, or rinsing may contain a cup of an anatomically adapted immersion configuration. Means are also used to deliver large quantities of liquid, usually by spray devices, to flush the eyes, for example, in emergency situations. The present invention mainly relates to devices designed to deliver relatively small amounts of fluid to the eye, as well as devices that are easy to handle to simplify frequent use, including in the conditions of self-treatment. A common prescription is to administer a drug to the eye. In a typical case, the medicament should be delivered in a sufficiently accurately defined amount to ensure that the prescribed dose is delivered or absorbed. Large excess amounts are unacceptable due to improper physiological effects of absorption by tissues that are not the object of treatment, or due to the flow of excess fluids through the tear ducts into the oral cavity or the inconvenience caused by pouring excess fluid onto the face and clothes. In addition, cost considerations play a role in relation to expensive drugs. For example, the treatment of glaucoma requires frequent daily doses, for example, prostaglandins, beta-blockers or other expensive active ingredients, each of which has a different effect, in contrast to the necessary pressure reduction, when it is absorbed not only by the eye, but also by other body tissues. In addition, the proper administration of small amounts is complicated by the fact that the active ingredients cannot enter the eye other than through a limited area of the cornea. Although the device described herein can be used with any liquid for any purpose, for convenience, the invention will be described mainly from the point of view of medical applications.

These circumstances impose stringent requirements on the device for the implementation of the main specified purposes. In order not to cause the aforementioned erroneous dosing, pouring, side effects and errors at the place of exposure, the required small amount of the drug should be delivered with great care to the eye. In a typical case, it is also necessary to perform secondary operations, such as alerting, checking the state of the device and the condition of the drug.

These requirements must also be met when using the simplest metering devices in the hands of an experienced operator who can also take medically acceptable corrective measures in case of errors and incorrect actions. This also applies to the use of more complex devices, for example, in a clinical setting. However, the general trend in treatment is the provision of the possibility of taking medication by the patient himself, including in cases with children, the elderly and people with disabilities. With long-term treatment, the patient often achieves certain skills, but there are also schemes with less frequent medication, often involving situations of urgent need or impairment of the patient’s well-being. Other unique problems with self-medication by the patient, compared with external assistance, are that less comfortable and often tense postures are required, and that the expected or experienced pain or discomfort can interfere with the medically desirable course of action. As a result, in particular, self-medication requires more advanced devices to facilitate the injection procedure and eliminate or reduce the risk of errors. Patients dependent on daily or periodic medication have a reasonable need for convenient and sufficiently autonomous devices for use in everyday life. It is also desirable that such an improved and convenient device remains simple and inexpensive for its wide distribution and includes disposable means.

Devices known from the prior art, only to a limited extent capable of satisfying these requirements. Known devices with manually controlled pumping mechanisms, for example, in patent documents XVO 98/55059 and I8 5607410, having features that provide ease of use and compactness for transportation, respectively. However, such devices involving the use of containers with multiple doses do not have special means for self-monitoring, for example, in relation to operations alert or monitor the condition of the liquid. For some reason, it is desirable to replace manually driven pumping mechanisms with some automated means, typically providing for the release of stored energy, for example, to control alerting, start-up, setting the force, speed, resetting, or setting the sequence. In addition, a special requirement may be caused by the need for high fluid speeds. Medical devices of this type are, for example, automatic syringes, when used, the injection of liquid occurs automatically after start-up, and needleless syringes, when used, penetration occurs due to the speed of the fluid instead of using a needle. For treating the eyes, it was proposed to use liquid jets directed at a fairly high speed in order to deliver the liquid quickly enough to advance the blink reflex, as well as to be able to deliver very small doses that are less than delivered by the gravity of the drops by injecting a controlled amount of liquid from pressure chambers through a narrow hole. Devices of this type are described, for example, in patent document νθ 96/00050 regarding multi-dose containers and in patent document νθ 96/06581 and in the simultaneously pending application PCT / 8E00 / 01514 of the present applicants for single-dose containers. The described proposals of this type are not optimized for use as portable or handheld devices, nor regarding the characteristics of convenience, nor regarding the suitability for additional automation.

Accordingly, there continues to be a need for simple and inexpensive injection devices capable of assisting the user in performing various operations when handling them, preventing or mitigating errors, and representing an ergonomic, convenient and non-traumatic product, especially convenient for patients to independently take medicines. Although the present invention may find wider application, it will be described mainly on the basis of these premises.

SUMMARY OF THE INVENTION

The main objective of the present invention is to provide a device for delivering a fluid that meets the basic requirements described above better than devices known from the prior art. A more specific objective is to provide such a device intended for use in a portable manual embodiment. Another goal is to provide a device that is convenient to use and is intended for independent treatment by the patient. Another goal is to provide a device that provides for the mechanized, rather than manual actuation of the liquid pumping mechanism. Another objective is to provide a device having means for initiating and / or controlling. Another goal is to provide a device designed to automate or motorize its operation. Another goal is to obtain a motorized device that saves energy and / or power. Another goal is to provide a device designed to deliver fluid at high speed. Another goal is to provide a device compatible with containers for multiple doses and for a single dose. Another goal is to obtain a device intended for use with one or more interchangeable containers for a single dose or multiple doses. Another goal is to provide devices with suitable auxiliary parameters that are not directly related to the treatment process, but related to refueling, initiating, checking, cleaning, managing and processing. Another goal is to provide the above devices for delivering fluid to the eye. Another objective is to provide an eye treatment device for convenient and accurate delivery of drugs, especially small volumes of liquid. Other objectives are to provide methods of operation of such devices and / or delivery methods corresponding to such devices.

These goals are achieved thanks to the distinguishing features set forth in the attached claims.

According to one aspect of the present invention, the device is designed to deliver fluid to the eye and comprises an eyecup mounted to provide the necessary relative positioning of the opening and the eye. The execution of the eyecup with the ability to move between at least two positions, that is, a working position that provides a safe distance between the hole and the eye, and a position near the hole can, for example, make the device more compact in the idle position, improving portability, and with an increased distance between device and a person in a working position can improve its convenience when handling manually and facilitate self-treatment. The ability to change the distance to the hole facilitates accurate orientation, which is important for accurate delivery and integration with the housing and pump mechanism, for example, eliminating the need for long channels between them, which is more compatible with high-pressure delivery. If a sensor or other means is used for position recognition, the functions of the device can be adapted accordingly, for example, to generate signals, actuate electronic means or mechanisms, block the device, etc. Without prejudice in other respects, you can add additional eyecup positions, for example, for initialization, refueling, etc. The movable joint can easily be made completely removable, for example, to facilitate cleaning or to provide a replacement or choice between different configurations and sizes of the eyecup. Mobility is compatible with enhanced functionality when movement, as such, not only when installing the eyecup, is a decisive factor. For example, the device may be active to move the eyecup to the operating position when the alerting or verification is completed successfully, or the device may passively accept the introduced movements, for example, when using the movement to alert or cock the mechanisms in the device. It is clear that the functionality outlined can serve to facilitate the suitability of the device for automation and motorization. Similar advantages can be achieved in applications other than eye treatments if certain movable parts of the device are made to move accordingly.

According to another aspect of the present invention, the device comprises an initiating mechanism included to actuate a container or opening for delivering liquid, and a drive means for converting the applied manually or stored energy to both the charging energy of the pump drive and to the energy for operating the initiation mechanism . The use of a cocking device to drive the pump means that the user can be freed from controlling the pump, and that it can be used to improve the accuracy of the exposure time, profile, and injection targeting and allows any pump power, container pressure, or fluid velocity to be generated. Using the same drive mechanism also for performing alert operations facilitates handling of hand-held devices and reduces the complexity of automated devices. Alerting operations are common with dispensing devices and may include, for example, moving a new single-dose container to the injection location, opening a sealed hole, mixing the initial components of the preparation, breaking the torn walls or safety elements, setting the dose, dispensing the contents of the container, putting it into operation status or shutdown of safety devices, etc. The invention is compatible with any such alerting operation or a combination of such perrations. The range of preparatory steps available also makes the device compatible with single-dose containers or multi-dose containers, with single or multiple container configurations, and with fixed or removable such containers. The need for peak force or energy can be reduced if the two conversions are separated in time or sequential. The same applies if two or more alerting operations are similarly separated. The device is compatible with both cases when the drive mechanism directly controls the initiation mechanism, or when the drive mechanism provides the accumulated energy in the charged state for the initiation mechanism. The principles outlined increase usability by reducing the number of operations required when handling the device. They also enhance security by enabling the control operations and the controlled sequencing of operations. Mechanization and automation of the device is facilitated by a combination of work steps and the ability to reduce effort and energy requirements. For the same reasons, the device mechanism

Ί can be simplified and made less bulky, which increases its portability and improves the characteristics of manual control.

Additional and more specific goals and advantages will be apparent upon reading the detailed description below.

Definitions

Unless reference is made to a specific detail, the term “system” as used herein is to be understood as referring to the principles of the invention as a whole, described, claimed, illustrated or implemented as one or more devices / appliances, methods, applications or combinations thereof.

In the absence of certain indications or obvious conditions to the contrary, the expressions used here, such as “comprising”, “including”, “having”, “with something” and similar terminology should not be understood as exclusively limited by the given elements of the device, compositions, compounds / components or operations of the method, and should be understood as allowing the presence of other elements, compounds / components and operations as well. It should be understood as encompassing any element of the device in whole, divided or aggregate forms, and expressions such as “connected”, “attached”, “located”, “applied”, “between” and similar terminology should not be understood as encompassing exclusively direct contact between these elements, and should be understood as allowing the presence of one or more alternating elements or structures. This also applies to similar expressions used to describe forces and actions. Similarly, in the absence of clear statements or obvious conditions to the contrary, such expressions should be understood as referring to compounds / components of the composition or state of the population, as well as to the operations of the method in any time sequence.

Also used here are terms related to the location and direction of both the container and the metering device, such as “axial”, “far” and “near”, “front” and “rear” and “forward” and “back”, should understood as related to the direction of delivery of the fluid, in relation to which the line centered in the opening of the container and drawn along the main or middle direction of delivery will be considered as the "axis" of the system along which the fluid is delivered in the forward direction.

In addition, the term “manually” used here in connection with the force or energy applied to the control means of the device should be understood as meaning that the operator applies directly or indirectly the force or energy in such a way as to control the procedure in question. It should be understood as including servos in which part or all of the force or energy from another source (not from the operator) is used, for example, the stored energy of a spring or gas or supplied energy to facilitate the procedure when the operator sets this behavior, although the assistance of the servo in most cases not required or not preferred. Unlike the “start-up” action, which can be an on / off action, a manual action carries, at least partially or within limited limits, a function related to setting to a predetermined position during the affected procedure.

Detailed description

General Provisions

The device described here can be used to achieve many goals in the field of medicine and outside of it with many types of drugs, such as chemicals, formulations or mixtures in any container and delivered for any purpose. For the purposes outlined in general terms, the system has some special indicators associated with medical metering devices, in which design restrictions are also more stringent than in most other applications. For convenience, the invention will be described with respect to this use case.

In the normal case, the delivered material is a fluid, preferably a liquid, including materials having liquid properties, such as emulsions or suspensions. These comments apply to the final preparation, while other components, in particular, solid particles, may enter into the final preparation. The nature of the contents of the container should also be understood as including medical devices in a broad sense and encompassing, for example, natural components and body fluids pre-charged or drawn into the container, although most often the medical device will be manufactured at the factory.

The principles of the present invention can be used to obtain metering devices or systems in a broad sense. The delivery channel from the device may be an infusion channel or any conductive devices, such as a tube or catheter, needle or cannula, or a needleless system based on a liquid stream or drip atomizer or aerosol device with or without a gas displacer. The material of the contents of the container must be delivered using a metering mechanism, also referred to herein as a pump or pump mechanism, and any material satisfying this requirement may be used. A normal substance is a fluid substance, preferably a liquid, including substances having liquid properties, such as emulsions and suspensions. These instructions apply to the final product, while other components, such as particulate matter, may be present in the final preparation.

The invention can be used to produce metering devices in stationary or permanent arrangements. With the stated objectives, the invention provides particular advantages when performing dispensing devices for outpatient use, in particular stand-alone devices with an integrated energy source, electric motor and processor, and, in particular, small hand-held devices of a truly portable nature.

Body

The term body of the device should be understood in a general sense, and for the most part it represents a control point, unless otherwise specified, for movements, as well as a control point for the forces exerted by the drive devices that perform these movements, in which a force is applied between the body and moving or gripping part. Moving parts can be present in pumping devices or, for example, in parts that mix, automatically pierce, extend and retract the needle, etc. The minimum functional requirement is for the housing to form a support or platform for moving parts and driving devices that communicate movement and exert force. In this context, such moving parts may be present in the pump mechanism, its drive or cocking devices, as well as in devices for preparatory operations and their drive mechanisms. However, as in conventional practice, it is preferable that the body form a case at least partially covering the parts, and preferably to such an extent that only those parts of the device that are intended to be controlled or monitored by the operator remain open outward. In this context, such exposed parts may include a manually operated button for injecting or starting injection, a container receptacle door to facilitate replacement thereof, a display for displaying messages to the user, etc.

Container

The term container should be understood in a broad sense, and it can take many forms, such as any type of tube, vessel, flexible bag, vial, ampoule, cartridge, capsule, syringe body, etc. Preferably, conventional materials such as glass or plastic may be used to make the container. The container may be an integral or composite structure, for example, including an outer shell or any other multi-element structures for closing, attaching, protecting, etc., and each time the term “container” is used here, it should be understood that it includes any auxiliary parts present . The container can be integral with the body, for example, when used in disposable devices, when the container can be refilled, or when the container is part of a pump system that repeatedly sucks the drug discharged from an external source or channel before each injection cycle. The container may also be a separate element, for example, to ensure its replacement in the case of pre-refilled disposable containers, to simplify sterilization or refuse it in case of changing the type of necessary contents or changing the patient. As is known per se, it is possible to use more than one container, for example, in the case when it is necessary to carry out mixing before injection, mixing during injection, when a part of the volume is sucked from each container, or in case of sequential injection of different components.

The container has at least one opening, also called a channel, through which the drug passes during the main delivery operation carried out by the device, either from the interior of the container into the environment, for example, to dispense the drug to the patient, or into the container in case of bodily absorption liquids or during drug preparation operations, such as filling, mixing or dissolving in a container, which require a hole. It is possible, and in many situations, it is even preferable that some device operations, such as preparatory operations, be performed before the message is established, and the requirements for the hole can be considered satisfied if there are preparatory devices for creating the message, such as a removable cover or a punctured or broken part on the container, as is the case with an ampoule or package, or a specially designed part, as is the case with punctured membranes or partitions. All communication can occur through one hole, for example, the passage of a medicine, and equalization of pressure in a rigid container, or when delivered from a flexible container or having a movable or deformable part, but nothing prevents the implementation of additional holes for similar purposes, which may be identical the specified at least one hole, or which can be completely different and, for example, intended for another purpose, for example, for infusion, or can be of a syringe type with movable th wall or piston.

The container may be a simple bottle, vial or bag if the metering device is adapted to suck out continuously or intermittently measured quantities of the substance for delivery, as prescribed. Often, and especially in connection with self-treatment, the type of container is more complex and usually comes in the form of a cartridge, which is the container part of the dosing system of the syringe type, which can be even more complex in the case of multi-chamber cartridges. Cartridge-type containers will be further described since they usually require additional preparatory or verification operations, for which principles of the invention can preferably be used.

The cartridge used to accomplish these purposes may typically include a container having a front and a rear that forms the common axis of the cartridge, a drug outlet located at the front and at least one movable wall located at the rear, while this wall causes the movement of the drug in the direction of the outlet and displacement through it. The configuration of the tank and the movable wall must be adapted to each other. The container may have a more arbitrary design when the wall is a flexible or oversized membrane or baffle capable of adapting by moving or changing the configuration to the inside of the container, in which case a liquid cushion or elastic material between the wall and the piston rod may be required to smooth out the pressure. However, it is preferable that the container has a substantially constant internal cross-section with a constant axis of the container between the front and rear portions, forming a generally tubular shape, and most preferably, it has a conventional circular cross-section, forming a substantially cylindrical container. The movable wall, in this case, preferably has a substantially constant configuration, although it can be an elastic element that fits snugly to the inner surface of the container, and can preferably be of the plunger type and can have a length sufficient for self-stabilization to prevent warping when moving along the container. The front outlet can be of any known construction and can be directed transversely for better access in some applications, forward, but not coaxially with the axis of the container, or, most often, forward and coaxially. The outlet may be integral with the container, or in the usual way, the front end of the cartridge may be provided with fixing means therefor and may have a punctured or punctured sealing means.

Typically, the described cartridges require several types of preparatory steps, depending on the displacement of the movable wall in order to bring the device to its original position and to provide repeatable and reproducible dosing that meets the requirements of high accuracy. Upon its first movement, the movable wall may require excessive tearing off after storage to overcome both internal resistance to configuration changes and increased wall friction due to adhesion or lack of lubricant at the contact points. Also, in relation to the weakening of the force during regular injections, the elastic and inelastic deformations and tolerances in the movable wall, cartridge shell, outlet fastening means, etc. must be smoothed out. The preparations themselves may have compressible inclusions, such as gas bubbles. Annealing and pre-ejection are required to remove gas from the cavity of the vessel and fill the cavities, for example, front seals, fasteners for securing the outlet and cavities of the exhaust means or needles.

Cartridges of the two- or multi-chamber type are known, for example, for preparations requiring mixing of two or more components or starting materials before taking the medicine. The components are stored separately by one or more intermediate walls of various known structures that divide the container into several chambers, sometimes parallel to the axis of the cartridge, but more often in a multi-tiered configuration along the axis. The components can be connected by tearing, puncturing or opening the valve structure in the intermediate walls, for example, by inserting a pin or needle through the front of the cartridge, through or onto the rear movable wall, or by means located outside the cartridge (see, for example, XV O 93/02720). In another known construction, an intermediate wall or plunger-type walls are used, and a flow message between the chambers is created by moving the plunger into the bypass section, where the inner wall has one or more enlarged sections or alternating annular grooves and protrusions configured in such a way that they allow you to create a bypass flow of the contents of the rear chamber into the front chamber when the rear movable wall is offset (see, for example, patent υδ 4968299 or application No. 0 93/20868 and No. 0 95/11051). The chambers may contain gas, liquid or particulate matter. Usually at least a liquid is present. Most often, in pharmaceutical applications, only two chambers are used, and typically they contain one liquid and one solid, the latter dissolving and a homogeneous substance is formed when mixed.

Initiating the readiness of multi-chamber type cartridges requires the performance of all the described operations of a general type, although in a complicated form due to the presence of additional walls and spaces. To ensure efficient mixing, in addition to the space occupied by the volumes of the components, a mixing space must be used. Powdered components in bulk form also require additional space occupied by the voids between the particles. The mixing operation may produce foam or gas inclusions requiring space for deposition. The intermediate walls of the plunger type should usually be offset at least by a distance equal to their length in order to achieve an uncompressed space in the bypass section. In general, multi-chamber cartridges require an extended stroke of the moving walls during the alerting operation for both mixing and subsequent degassing, and especially benefit from the advantages of the present invention.

In general, the described containers can be used to inject both a single dose and multiple doses. In medical applications, a device for injecting multiple doses often entails the risk of contamination or loss of sterility of the contents of the container after opening and first use, which may require antiseptics in the preparations. These problems can be resolved using single dose containers that are opened in connection with the injection operation and then discarded. For cost reasons, simple and cheap single-dose containers have been proposed having an opening and at least one soft or deformable wall, and it is possible to increase the pressure of the contents of the container by squeezing the deformable part or striking it. Different compression directions can be used, for example, perpendicular to the axis of the hole, although it is often preferable to use a direction parallel and preferably coinciding with the axis of the hole and oriented forward. Such containers have been proposed for various delivery options, for example, for injection with a needle, as described in patent RK 1538565, for injection with a penetrating jet, as described in patents υδ 2642062, ϋδ 3419007 and υδ 5026343, and for treating eyes, as described in patent application No. 0 96/06581 and in the совместно0Τ / δΕ00 / 01514 of the present applicants referred to in the introduction of the jointly pending application. Containers of this type can be used for the purposes specified here, and the most preferred design is described in the specified jointly pending application. Such a container may comprise a front wall having either a surrounding cavity corresponding to the shape of an open vessel, an opening in the front wall adapted to inject liquid from the container, optionally sealing means (sealing means) over the opening adapted for temporary use, and a rear wall covering and clogging the open part of the tank of the front wall to form a closed space for liquid in the container, while the rear wall passes at least part which is perpendicular to the axis of the container and can be displaced or deformed with movement in the direction of the hole for compressing the liquid in the container. The front wall is substantially rigid relative to the rear wall, the back wall being substantially flat or essentially expanding on the plane until the container is compressed, the back wall being tensile deformed and essentially fills the cavity of the container. The pumping mechanism for such containers may include a pusher that presses or strikes a soft or deformable wall, as will be further described below.

Although the above arguments apply to individual containers for single and single use, it is preferable to use multi-container units or bags. This can be accomplished by joining several individual containers into multiple structures, for example, by flexible joints to obtain structures that can be bent, folded or rolled up. However, it is preferable that the multi-container bag has a substantially rigid and self-supporting structure, among others, giving the advantage of being connected to a metering device. A rigid structure can be obtained by connecting individual containers with rigid connecting means, but it is preferable to use the aforementioned stiffness of the front wall by making an enlarged structure of the front wall and making several recesses in the structure, which, among other things, facilitates the production of multiple containers and ensures smooth and a simple external surface. By using the feature of manufacturing the front and / or rear surface of the front wall structure flat or unfolding on a plane, the application of films on these surfaces is further simplified, especially if the surfaces of the containers lie on the same plane, since in this case several and preferably all individual containers of the structure solid sheet material can be applied, for example, a common sheet of film can be applied as a back wall to the back surface of the structure, or a common tear-off A sheet may be applied over the openings of the containers to the front surface.

The general configuration of the front wall structure for a plurality of containers can be imparted in many different shapes, but the substantially flat front wall structures provide advantages in manufacturing and in the design of the metering device. The configuration may be, for example, rectangular, square or round. The configuration in the shape of a round “disk” was found to be particularly favorable, inter alia, in connection with a metering device in which the sequential supply of containers to the injection point can be carried out by simply rotating the “revolving” type, while the absence of any starting point simplifies handling and counting devices and provides for self-centering qualities.

Most types of containers can be arranged in multiple arrangements, if necessary, and the initiation operation for any such arrangement can include the operation of supplying a “fresh” container to an active injection site or supplying an active injection site to a location of a “fresh” container.

As noted, it is preferable to temporarily seal (seal) the opening or openings of the containers until the actual injection of liquid to maintain complete tightness of the container. The sealant should be torn or removed immediately before use. Although a manually-tearing or pressure-breaking sealant may be used, it is often preferable to use a removable sealant that eliminates any separation of particles from the sealant to provide fully predicted dynamic characteristics and involves the use of more reliable thick and strong layers. Typically, the sealing means (sealing means) can be formed integrally with the front wall, for example, by molding so as to leave a membrane of material somewhere in the channel of the hole. However, it is preferable to use a separate removable layer to remove it before injection, preferably attached to the front surface of the front wall. It is preferable to exclude the use of glue and binders and it is preferable to use some form of welding, for example, ultrasonic or thermal. To facilitate removal and interaction with the area of the hole, the sealing means may be configured to cover a limited area surrounding the hole. In multi-container structures, it is preferable to make the layers separately removed from each container, for example, by using separate films, pre-cut films or separate reeds, for example, in a star configuration for a round disk. Regarding the material of the film, the same considerations can be applied as for the material of the back wall, although it is not necessary that the film is deformable under tension, and the requirements for impermeability can be slightly reduced due to the small area of the hole. The operation of alerting such containers may consist in removing a temporary sealing means prior to injection.

Hole

The design of the orifice may vary depending on the nature of the liquid stream to be formed, for example, atomized spray or concentrated stream, so that it remains coherent or breaks to form a linear stream of discrete drops. In addition, the speed of the jet can vary from a high-penetrating jet to a low-speed jet directed to the surface. Multiple or multiple openings may be used, for example, to provide controlled irrigation, although in most applications a single opening is preferred. The geometry of the hole can be represented by the shape of a simple tube, an expanding channel, for example, to obtain a sprayed jet, a tapering channel, for example, to ensure the formation of a coherent jet, or a combination thereof, such as a channel such as a venturi. In high-speed applications, it is usually preferable to make a short channel portion of the hole to maintain low flow resistance. Although the hole may be soft, for example in the case of infusion tubes, advantages in accuracy can be obtained with a rigid hole design. The hole, in turn, can be connected by a tube to the container, for example, in the case of supply tubes, although the hole can also preferably be directly attached to the container. The hole will be described here as an outlet intended for delivery of the drug to the destination, for example, to the patient or to the inside of the patient, for which at least the most terminal part, the very front part of the channel should be intended for delivery to the destination. Depending on the delivery vehicle used, the front end may not be intended to come into direct contact with the delivery site, as is the case with sprayed jets of liquid, when the front end may be a slot or hole to be located at a distance from the destination (delivery) or on the surface object, despite the fact that the true destination area is below the surface. In other cases, the front end is designed to penetrate to the destination, as is the case with cannulas or conventional needles. The channel between the front end and the rear end can be curved or elbow, as is the case with a flexible infusion tube or integrated permanent connection, although in many applications it is desirable that the channel is essentially straight, as is the case with a needle on the syringe.

Pump mechanism

The means for delivering the drug through the opening of the container must include at least one type of pumping mechanism that can be matched to the particular type of container and drug used. The pump mechanism may include any type of pressure source, such as a mechanical or electrolytic means to increase the pressure in the container, and appropriate valve control devices, and this method can be used with almost any type of container and any type of substance, for example, for transdermal delivery with liquid jets, as described in application XVO 94/2188, or regular infusions through a tube, as described in application νθ 88/09187. Any type of container can also be used with pumps based on peristaltic action or centrifugal action, although pumps based on controlled direct displacement, and especially such pumps based on the action of a separate cylinder and piston, are also preferred for general use, as described in I8 5480381 , for the formation of a jet of liquid or in patent I8 4564360 for a manually driven device based on the use of a needle. A typical syringe-type container requires a specialized pumping system. The tool is either intended to act on syringes in a complete set, having their own piston rods, by contacting and moving the specified rod, as described in patent I8 4978335, which may be preferable when it is necessary to place syringes of many different types and sizes, or has a piston rod acting more or less directly on the piston of a cartridge-type container, as described in patent applications νθ 95/26211, EP 143895 or EP 293958, which can be made with smaller dimensions and larger e is adapted to portable devices. Also with such devices two- or multi-chamber cartridges for their various phases can be used, as described in the application νθ 93/02720. Although the various pumping mechanisms described may include mechanical devices for acting on a drug or piston, devices such as a piston rod may be actuated by any known means, such as gas pressure, vacuum, hydraulic means, springs or manual action.

Preferably, the mechanism may include other components. The mechanism may, for example, include special devices to ensure the accuracy of the delivered doses, for example, by directly measuring the delivered quantity of the drug, although it is usually preferable to use, directly or indirectly, a pumping mechanism, for example, by tracking the axial displacement or rotation of the axis of the piston rod essentially a way.

The pump mechanism may also include a manual control means forming a link between the actions of the user and the actual movement of the pump. In the case of stored energy, the control means may be in the form of a trigger releasing, for example, a valve or a mechanical lock. In the case of manual control, the control means can be in the form of a drive, directly or through a system of connections for moving the pump. Preferably, the connection system includes a lever device that can be used to reduce the applied force, for example, when the drug is released too easily, or when a reduced stroke length is needed, but preferably it is used to increase the applied force or increase the length for drive stroke. The manual control means may include conventional safety features, such as a switchable fuse or command means, ensuring the safety of the device for children.

In other pumping mechanisms known in the art, pressure is increased in a small cavity with a liquid by rapidly and partially heating the liquid to form steam or by compressing the piezoelectric element. In the alternative 19, the pressure does not increase, but the fluid associated with the surface is ejected by vibration of this surface. Such techniques are used to deliver small droplets with quick succession, for example, in inkjet printing devices, but they have also been proposed for medicinal purposes. The previously mentioned patent applications νθ 96/06581 and EP 224352 describe a piezoelectric element and an electrostatic agent for treating eyes, vibration techniques are described in patents EP 615470, I8 5518179 and I8 5838350, and a pulse-bubble technique for treating eyes is described in application νθ 94/03135. Such pumping mechanisms can be used for the purposes indicated here, especially for delivering small drops, which is sometimes necessary in the treatment of eyes. In medical applications, it is desirable to use these techniques in combination with single dose containers, for example, to better maintain sterility, as described.

When applying the present invention in combination with a pump drive operating using charging energy, it is preferable to use pumping mechanisms that create relatively high forces or strong effects, since such devices especially benefit from the advantages of charging, for example, the ability to use a rather weak motor or manual force to accumulate energy in a cocked device. It is also preferable to use pumping mechanisms based on a fairly simple trajectory, such as rotational or translational motion, for example, when using a pusher to increase pressure in the described soft or deformable containers or devices of the piston / cylinder type in suction / injection systems or syringe-type devices.

The energy can be stored in the cocked device in various forms, such as electrical, magnetic, etc., although it is preferable to use pressure, for example, gas or hydraulic springs, and mechanical energy, preferably mechanical springs, is most preferred.

Similarly, the energy supply to the drive mechanism may take various forms. Energy can be supplied manually. Any other forms of stored energy can be used, for example, the above forms, although, preferably, the energy is electric, for example, supplied to the device from the outside, or, preferably, the energy of the built-in battery, converted by any electromechanical device, such as a solenoid or, preferably, an electric motor .

Preferably, somewhere between the energy source and the pumping device, a means for transmitting motion (transmission) can be located, for example, for varying the force, for separating the energy also for preparatory operations or for influencing the establishment of the sequence. In a typical case, the means for transmitting movement (transmission) includes a gear for changing forces from low to high. This means for transmitting movement may be located after the cocked mechanism for storing energy, but it is preferable to place the specified means in front of the means for storing energy, in a typical case, in order to ensure that the means for storing energy force, which exceeds the effort when charging. In this case, any known mechanism for changing the force can be used, for example, a lever device, a device with a threaded spindle and a nut, or a gear device. Alerting (initiation)

As noted above, different types of containers may require different alerting actions. For example, a syringe-type container may require preparatory movement of the piston for various purposes, such as mixing the starting components. The piston / cylinder fixture may require suction from a vial or feed tube. A multi-container fixture may require moving a new container to an active injection point, also called step-wise movement here. It may also be necessary to remove temporary sealing means, also referred to here as printing (depressurization). All possible alerting operations will not be re-listed here.

Additional alerting operations may include verification operations performed to rule out a malfunction or to provide all necessary conditions for successful operation. Such verification operations can be checking the presence of the container in the container slot, checking whether the container has already been used, for example, if it is empty, checking the availability of temporary sealing medium before removing it, checking the position of the hatches, covers, position of the eyecup, etc. .d. Such verification operations can be used to prevent start-up or to give a warning signal until all the necessary conditions have been reached. As for the above alerting operations, some of these verification operations can be performed using microswitches or simple mechanical locks or latches, but to the extent that these verification operations require moving parts that require significant effort or power, these operations can be carried out as the following alerting operations.

Although the initiation operations can be carried out manually or using separate drive systems for the purposes indicated here, there are advantages in using the same drive mechanism not only for the cocking operation, but also at least one initiation operation. Depending on the required force during initiation, an increase in the force applied to lower the rotation speed and, possibly, a cocked initiation device may also be required as for the pump drive, and, in this case, it is possible to use one device for both purposes. Alternatively, for example, if the demand for effort or speed is small, the operation can be carried out directly without a cocking device and up or down transmission, or the transmission may not be used at all. Often two actions require different driving characteristics or are applied to different parts, which requires at least some different parts in the drive mechanism, which is often preferred.

Regardless of the distribution of functions of the drive mechanism, there are various alternatives for establishing a sequence of actions. The cocking and at least one triggering action can be carried out simultaneously or at least partially simultaneously, for example, cocking and stepwise movement, for example, to save time between operations. The simultaneous action can also be carried out as a result of the movement of one part with two targets, for example, when using one cocking system for two purposes, but it is preferable to use different parts of the drive mechanism. In most cases, time is not a critical factor, and it is preferable to perform actions at least partially sequentially, for example, to reduce the need for the applied force and power of the drive device, which is especially important for portable devices. More than one initiating operation can be included in the device’s usage cycle, for example, the steps of stepping, removing the sealing means and checking, and in this case it is preferable to perform at least two or more actions in order to enhance these advantages.

Some sequencing can be achieved without any active mechanism switching. For example, one movable element can carry both a plunger or a pusher for injection, and a pin for removing the sealing medium located closer to the front side, which ensures its appearance at the operating point before the plunger is ready to perform injection. Different times of occurrence at the operating point can also be provided without the need to place parts on one part of the device or to actuate parts of the drive mechanism. However, in a normal situation, some switching devices are required to establish a sequence. Typically, the drive system needs to be disconnected from the cocked fixture. This can be done by locking the cocked device in the cocked state and releasing the mechanism by disconnecting to continue driving or by changing the direction of the engine. Similar actions, including setting a different appearance time at the operating point, can be used to establish a sequence between several alerting actions.

Work management

The operation of the device may include the necessary operations for injecting liquid, operations alert and verification operations, when provided, and any interaction, for example, establishing a sequence as described. The control can be carried out completely by means of software for the greatest flexibility, provided that the actuating devices present are sufficiently equipped for individually actuating the various parts for performing the movements prescribed by him, such as separate motors and solenoid-controlled locking and blocking devices. Sensors or microswitches located at critical points of movement may also be required to ensure proper spatial positioning between parts. Such parts can be controlled by electronic means, such as a microprocessor with appropriate software.

However, it is often preferable to use mechanical devices that assist in control for safe operation, and they may be necessary if one engine is used for different purposes, for example, to perform the above cocking and alerting operations. Mechanical switching devices can be easily positioned so that they are driven by moving parts at critical points. Nothing prevents the use of combined devices with software and mechanical means to ensure high security and functional redundancy.

Even if the basic functions of the device are controlled mechanically, it may be useful to incorporate electronic means into the design for various auxiliary purposes, for example, to warn or signal, for example, a warning message or instructions to the operator, for example, by means of light, sound, vibration or message on the display. The use of a display can also serve to inform the user, for example, of the time periods between doses of the drug, the remaining doses in the case of containers for multiple doses or with multiple containers for one dose, the state of the device, etc. A processor and memory device may also be used. to remind about the time and doses taken, for example, to monitor compliance with the intended purpose and, possibly, such data can be sent from the device, for example, from the built-in erasable programmable ohm permanent storage device via infrared communication line for further processing in external equipment.

For the various drives described, stored energy in any known form can be used, such as electrical energy, gas pressure or gas generation energy, or preferably mechanical energy, the latter being preferably used in the form stored in elastic elements such as springs. The stored energy can be converted into force using appropriate conventional converting devices, for example, electromechanical, such as electric motors or solenoids, hydraulic, pneumatic, etc. systems, but it is preferable to use mechanical springs.

Details will be given below of the use of sensors and signal processing in the device in connection with the description of the mobility of the eyecup, since the general principles mentioned here are equally applicable to other parts of the device.

Application options

As indicated, the distinguishing features of the present invention are widely used and can be used in many applications. The invention may find special application in cases where it is desirable to replace manually driven pump mechanisms with some type of automated means, typically involving the use of accumulated energy, for example, for controlled alerting, actuation, setting forces, speed, initialization or sequencing. The invention may also find special application in embodiments in which high fluid velocities are required. Medical devices of this type are, for example, automatic injectors, with which the injection of liquid occurs automatically after actuation, and needleless syringes, with the use of which penetration is due to the speed of the liquid, and not the use of a needle. For treating the eyes, rather high speeds of liquid jets were proposed in order to deliver the liquid fast enough to anticipate reflex blinking, as well as to ensure the delivery of very small doses that are less than delivered by gravity by injecting a controlled amount of liquid from the chamber under pressure through a narrow hole. An embodiment of the invention for treating eyes will be described below.

Eye treatment

A preferred embodiment of the invention relates to ophthalmic treatment of the eyes with drugs. Common methods for taking medications are using eye drops or ointments, however, these methods have several drawbacks. Both methods usually deliver significantly larger quantities of drugs than those that the eye can absorb, which not only leads to inaccurate dosing and the loss of an expensive drug, but also to potential side effects when an unabsorbed drug drains through the tear ducts, such as beta -blockers used in the treatment of eyes, cause significant systemic effects. Another problem is that conventional methods of drug administration can cause reflex blinking, which can completely disrupt treatment or, at least, introduce a high degree of inaccuracy in dosing. In addition, traditional methods do not provide high accuracy of targeting, for example, the ability to get into the iris of the eye, which is part of the eye designated for penetration of prostaglandin. The principles used according to the present invention solve these problems, inter alia, due to the ability to deliver small amounts of liquid that are actively injected and not determined by the surface tension of the liquid, due to the possibility of delivering the liquid at a sufficient speed to prevent reflex blinking, and due to the ability to inject concentrated and coherent stream for precise aiming. Typical parameters for this embodiment of the invention will be given below, although the invention should not be construed as being limited to any such illustrative parameter. A typical single dose for delivery to the eye may be less than 25 μl, preferably less than 15 μl, and most preferably less than 10 μl. Typically, this amount is at least 1 μl, preferably at least 2 μl, and most preferably at least 3 μl. Since it is desirable that each container contains a single dose, these figures also refer to the volume of liquid charged and contained in the containers, possibly providing some excess volume to compensate for non-sprayed amounts, for example, liquid remaining in the form of a moisturizing film or in the channel of the container opening, for example, an excess of 25%, but preferably not more than 10%. In addition to the liquid, the container may contain other material, for example a gas, such as air or a purge gas, such as nitrogen or inert gases, for example, to facilitate production, facilitate atomization, or act as a pressure buffer, although in many cases a small amount of gas or his absence. A suitable injection velocity of the droplet or jet stream must balance between, on the one hand, setting enough movement to cross the air gap between the hole and the destination without gravity and to communicate fast enough to prevent blinking and, on the other hand, obtaining speed not so high as to cause an unpleasantly felt blow to the eye. The ideal speed to some extent depends on the droplet size used, but as a general rule, the droplets should be able to cross an air gap of at least 1 cm, preferably at least 3 cm, and more preferably at least 5 cm due to its own momentum, that is, distances that include acceptable distances between the hole and the destination. A suitable lower speed limit at the outlet of the hole is 1 m / s, preferably at least 5 m / s, and most preferably at least 10 m / s. Typically, the speed should be less than 200 m / s, and preferably less than 100 m / s. The suitable size of such droplets should be sufficient so that they do not slow down the movement too quickly and cannot easily change direction, for example, cannot be inhaled, and preferably, the drops should have a minimum diameter of 20 microns, preferably at least 50 microns, and most preferably at least 100 microns. The normal size is less than 2000 microns, and preferably less than 1500 microns. The jet may take the form of a shower or a jet of sprayed liquid droplets, but it is preferable that the jet be narrow and fairly coherent, although even in this case, the jet tends to break into separate drops after some time after passing some distance. The above values refer to spherical drops, and in the case of many drops, to the average value of the diameters of the drops. The coherent jet tends to break into droplets whose diameter is approximately two times the diameter of the jet. Accordingly, suitable container opening diameters are about half of the above droplet diameters, or from about 10 to 1000 microns, preferably from 20 to 800 microns. The above arguments are somewhat independent of the viscosity of the liquid and can be applied to both solutions and ointments.

Eye cup

Many of the advantages provided by the invention are achieved without using an eyecup of the device, and the operator assumes responsibility for the orientation and stabilization of the device. However, it is preferable to include an eyecup in the design of the device to relieve the operator of these responsibilities. A suitable eyecup comprises at least a rim and a notch.

The purpose of the rim is to provide contact between the device and the face, and preferably also to self-center the device in a predetermined position relative to the eye. Contact can be made with any part of the face, such as the forehead, nose, and cheek, but usually better centering is achieved if the rim comes in contact with the eye socket. The term rim should be understood in a broad sense as a point or points of contact, and it may not be configured as an edge or other elongated part, but may form at least one contact point, preferably two, three or more points distributed in two dimensions for best centering. It is preferable to configure the points in the form of one or more continuous edges, and most preferably in the form of a continuous loop. For this description, it is assumed that the line can be drawn so that the contact points are connected to the contact curve, which also represents the theoretical contact points of the face who are not actually in contact with the rim, and in the case of a closed continuous rim, it is assumed that the contact curve and the rim edge match up. The plane containing the contact curve forms the theoretical “contact plane”. A line drawn perpendicular to the plane of contact forms the “axis of contact” and “direction of contact” along the axis from the device in the direction of the eye, or, expressed differently, from the recess in the direction of the rim. The axis of contact and the direction of contact should be considered "symmetrical" if, with respect to the device, they are centered within the contact curve or, with respect to the patient, they extend radially to the eyeball. Suitable rim shapes are known in the art and are not very critical to the invention. It is preferable to use the rim configuration with left / right symmetry in order to make it equally suitable for both eyes with a similar holding device. For example, a rim may be used having a contact curve substantially in the shape of an ellipse, adapted in size and shape to the eye socket. The contact plane passing through such a generally elliptical shape can be flat, although often it can be slightly curved along an axis parallel to the short axis of the ellipse. Preferably, the rim can in a known manner have eyelid-extending protrusions, preferably in the direction of contact for special contact with at least the lower eyelid, but preferably also with the upper eyelid to displace and hold the eyelids. From the point of view of design, the rim may have a soft edge for a more comfortable feel, made of a material with a high coefficient of friction on at least one leading part of the eyelid. The rim may be integral with the recess, but it is preferable that it be a separate part, attached, glued or welded to the part with the recess for a more free choice of material or color contrast.

The recess serves to obtain space within the boundaries of the contact curve for the protruding eyeball, as well as to ensure a safe distance to the eyeball from any part that is in front of it, especially from the hole, which will be further described. Accordingly, the term notch should be understood in a broad sense for any design that meets the specified purpose. The recess may be substantially cup-shaped, as with known eye baths, but does not have functions as such, and it is preferable to have a more open shape, for example, providing access to the opening for opening and closing to prevent accumulation of the drug and facilitate cleaning , to provide the operator with the ability to visually control hole orientation and delivery, to facilitate production, etc. The minimum requirement is that the design of the recess provides support and attachment of the rim, for example, using one bracket or rod, departing from the rim in the direction opposite to the direction of contact, although two or more brackets can be used, for example, in a cellular type construction. While the additional details are described below, we note that the eyecup should be located around the opening of the container in such a way as to ensure the delivery of fluid to the eye and, in particular, into the contact curve of the rim. The relative position may depend on the principle of delivery with particular freedom in delivering drops, but it is usually preferable that the hole is located behind the contact curve, when looking against the direction of contact, and with a projection along the direction of contact inward of the specified curve. Preferably, the opening may be directed into the recess or may be located therein, preferably at least with a component that determines the direction of fluid delivery parallel to the direction of contact. Preferably, a safety distance is maintained between the apex of the opening and the contact plane to prevent contact with the eyeball during any predicted individual anatomy and to prevent the patient from being afraid of such contact, for example at least 5 mm, preferably at least 8 mm, and most preferably at least 10 mm. The aforementioned support and attachment of the rim by the construction of the recess may be carried out using the container or its opening, but it is preferable to attach the rim to the hand-held part, for example, to ensure unimpeded replacement of the container.

The eyecup can, if necessary, include auxiliary features, such as parts that facilitate proper use and aiming, for example, gaze point, for example, a mirror, light, etc.

Eyecup mobility

When using an eyecup, it is preferable to make it movable relative to the body. It is preferable to make the eyecup movable between at least two positions, that is, a working position that provides the described safe distance between the hole and the eye, and a position closer to the body, for example, in order to make the device more compact in its inoperative state. The opening of the container can be fixed relative to the eyecup, for example, it can move along with the eyecup, but in many cases it is preferable that the eyecup move relative to the hole, which in this case is located in a fixed position relative to the body, of course, while retaining options for replacing the container or moving multiple containers to or from the workstation. The eyecup can be moved to a greater number of positions, for example, further from the housing or hole than in the working position, for example, to obtain better access to the eyecup or parts of the housing, etc. Preferably, the eyecup may be completely removable from the housing, for example, for cleaning purposes. The eyecup may be movable in any direction to meet the above requirements, for example, such that the contact direction of the eyecup has at least a motion component along the axis of the hole. The movement may be simply translational or may have a rotational component, the latter being preferably obtained by hinging the eyecup or its fastening means. Preferably, at least a portion of the positions are clearly defined, preferably at least an operating position, and preferably also a starting position, for example, by means of friction, a snap fastener, ball locks, or even a completely releasable locking means.

It is preferable that a sensor or other means for position recognition be used, and it is preferable that a signal is generated by which the device can be used for its intended purpose. The signal may show differences in all possible positions continuously, although it is often preferred that the sensor provides separate signals, for example in at least one, preferably in at least two, and most preferably in at least three positions. The signal may be any type of signal, if it allows transition to action, it may preferably be an electromagnetic or mechanical signal.

The signal received from the sensor may be in the form of (or converted to) an electromagnetic signal.

The electromagnetic signal may be based on electromagnetic radiation, for example, as an optical signal, but an electrical signal is preferred. There are many suitable components for use as sensors for delivering the indicated output signals, but otherwise this function can be performed by a circuit that produces such an output signal. As a converter of the sensor output signal to an electromagnetic signal, any integral, built-in or separate devices can be considered. For example, at least one microswitch may be located along the path of translational movement of the eyecup or along the path of rotation, for example, a cam surface located on the axis of the hinge.

Similarly, the signal received from the sensor may be in the form of (or converted to) a mechanical signal characterizing the position of, for example, the part connected to the movable eyecup and in some way moving with it. Any transmission device with the same arguments as for electromagnetic signals can be used as a signal-to-motion converter. You can transform an electromagnetic signal into a mechanical signal, or vice versa, or mix them in a chain of signals.

Thus, the received or converted signal can, in general terms, be processed, for example, by a processor or transmission to supply a control signal. The control signal, in turn, is used to control the functional or operational component of the device. Working components can be any type of component, although some typical examples will be given below. In addition, the control signal can be of any nature, for example, it can be mechanical, optical, etc., depending on its further use.

The control signal can be used to transmit a message to the user, for example, to warn or warn the user about the unsuitable condition of the device before the device is activated for drug delivery. The message may be an audible, tangible signal, such as vibration, a visual signal in the form of a warning light, or a more complex message on the display, etc. or a combination of such signals.

Preferably, the control signal is used to control the basic functions of the device, mainly before the actions taken by the operator. The control signal can be used to unlock or block the device, respectively, depending on the true state of the eyecup. Unlocking / blocking may be via mechanical coupling or electromechanical coupling, such as a relay blocking a mechanical function, for example, a piston rod or a pump mechanism. It is preferable to implement this function with devices having at least partial automation means for driving the device, such as an electric motor, the operation of which can be set by a control signal. It is more preferable if the device additionally has a processor for controlling the electric motor, for example, for providing predetermined control of the container, initiating, establishing a sequence of actions, dosing, forming feedback for issuing data on the drugs taken, etc., while providing better flexibility functioning in the processor may receive an electromagnetic signal, for example, allowing the processor to issue a signal of activation (initiation) of the electric motor only to when the necessary state of the eyecup is reached, or only when the alerting operations are correctly completed, or when the set state is checked with a positive result in the implementation of the self-monitoring program. As a processor receiving an electromechanical signal and issuing a control signal, a processor unit known in the art can be used.

The control signal can also be used to actually initiate the device, that is, as soon as the sensor gives a signal about the state of the set position, an automatic function is started. Regarding said unlocked / locked state, this initiation function can be used to start a purely mechanical drive means by means of an electromagnetic trigger, preferably together with an electric motor, and most preferably with a processor-controlled device automation.

Preferably, the device is designed to implement at least one of the initiation and injection sequences. In a preferred embodiment of the invention, the device is designed so that it can be activated only when the eyecup is in the operating position or active state. The initial position or initial state may, for example, include blocking the initiation, placing the device in a state of low energy consumption, or initiating a new cycle of alerting operations. In the third position, a signal may be given about other states of the device other than the initial state or the operating state, for example, the restored state or the replacement state of the container, and it may include the operation of providing access to the socket for the container. It is also preferable that the movement as such, not only when changing the position of the eyecup, be a critical factor and be used to carry out the action. For example, the device can be in working condition and move the eyecup to the working position when the initiation or verification operations are successfully completed, or the device can passively receive the notified movement, for example, using movement for triggering or cocking mechanisms in the device.

Obviously, the above general principles for the use of sensors can also be used in devices for other purposes than eye treatment. In this case, the operations actually unlocked or triggered may have a different character. Preferably, at least injection can be influenced by multiple dose devices, possibly including mechanical or, preferably, electrical means to control the delivered dose. In needleless syringes, sensors can be used for contact triggering. In devices such as automatic syringes, the auto-puncturing operation may also be affected, preferably so that the auto-puncturing and auto-injection sequence is controllable, possibly with the final needle retrieval operation. Automatic syringes are known that either deliver the drug during the puncture phase or allow injection after the puncture is completed, the invention being compatible with both modes of operation. In the case of multi-chamber cartridges with overflow or bypass designs that are known per se, the injection procedure may include sequential injection of different drugs, for example, first an anesthetic drug, followed by the active ingredient, or first an active component, followed by a flushing component.

Preferred Embodiment

Below are some considerations regarding an embodiment of the invention in which the device is intended to use the container types described above with reference to the co-pending application PCT / 8E00 / 01514 of the present applicants and, in particular, the multi-container device described in the arrangement of a turret type disk .

A dispensing or dispensing device for this purpose may typically comprise a housing with a receptacle for a container or container structure, a pusher that can move relative to the housing substantially in the direction of the axis of the container when it is installed in the receptacle, and a drive device that drives the push rod.

The casing should contain a slot for a container or several containers, the minimum requirement for which is that at least the empty container should be held in a fixed position relative to the pusher, preferably so that the axis of the container and the axis of movement of the pusher are parallel and most preferably aligned in relation to the part of the pusher striking the rear wall of the container. Preferably, the nest should be capable of containing containers with the characteristics described herein. Preferably, the nest holds the container under the action of the forward forces exerted by the pusher, and preferably also some forces acting back and in lateral directions. Preferably, the socket should ensure that the entire surface of the back wall over the recess will be open for the pusher, and at least the hole or holes on the front side of the container will be open so as not to obstruct the flow of liquid, although the rigidity of these containers ensures that the need for any strong support. Preferably, the nest is also adapted to allow easy replacement of individual containers or step-by-step movement of individual containers of a multi-container structure to a nest working point, for example, due to the presence of a guide along which the structure can be moved in one or two dimensions. In a preferred embodiment of the containers arranged in a ring, preferably on a disk-shaped structure, the disk can be rotated around the central axis of the disk to align the containers with the work station in accordance with the revolving principle. Such step movements can be carried out as an initiation operation, for example, before cocking the spring (or after it) for the implementation of the pusher injection action. In devices with one container, and in particular in devices with many containers, it is preferable to use guiding devices to ensure accurate alignment with the axis of the plunger to achieve the desired high delivery accuracy, for example, structures that interact with each container in a bag with at least one fixing structure on the housing, socket or, preferably, on the plunger, adapted for mutual engagement with a given alignment. Preferably, the mutual engagement may be associated with a signal for stopping in the correct position, for example, a tangible or audible signal during manual operation or a signal detected mechanically or electronically during automatic operation. In addition, it is preferable to include in the device a counting means, manual or automatic, mechanical or electronic, designed to track the number of used or remaining containers and to prevent or prevent the reuse of empty containers.

The plunger may include a plunger head and a piston device for moving the plunger head along the axis of movement. Although it is possible to make the plunger head inappropriate for the recess of the container, for example, for use with different recess configurations or relying on the elastic properties of the rear wall to empty the container, it is preferable to make it so that the head completely fills the cavity. This can be achieved with a soft and adaptable plunger head, for example, so that it is compatible with different forms of recess for expanding the range of application or to obtain a certain order of emptying, preferably for squeezing the liquid from the peripheral parts of the recess in the direction of the central, axial parts, which can be obtained, for example, by making the soft plunger head in a slightly flatter configuration than the recess configuration. However, for a single recess shape, it is preferable to make the front surface of the plunger head substantially identical to the internal surface of the recess or, in other words, the rear surface of the front wall in the container space. The plunger head can be surrounded by a support, for example, a tubular structure, inside which the plunger head moves, which preferably also abuts around a recess for sealing the space between the plunger head and the recess, at least during the movement of the back wall when it sags, for example, to provide high pressure or reduce the risk of leakage. The design of the piston portion of the plunger is usually not critical with respect to the dynamics of injection, but rather is important for translational motion and will be described in connection with the drive system.

The plunger can be driven using various mechanisms and energy sources. The mechanism can be driven directly by manual force, in which case, however, it is preferable to use the action of a lever or gear to amplify or convert the force or speed, preferably in the direction of decreasing speed and increasing force. To obtain a controlled and consistent result, it is usually preferable to have an automatic function in the sense that after the start by the operator, the translational movement is automatic and preferably irreversible due to the stored energy. Energy can be stored in any way, for example, in the form of energy from a mechanical spring, gas spring or gas generator, electrical energy, or a combination thereof. Energy can be transmitted to the pusher by a suitable engine or transmission, for example, an electric motor or a solenoid in relation to electric energy, a device with a piston and a cylinder in relation to gas springs or gas generators and an axis of rotation or a plunger in relation to coil and coil springs, respectively. It is usually preferable to include a transmission between the engine and the pusher in the structure, inter alia, to provide increased force, for example, by using a transmission such as a gear train or cam surface. Preferably, when moving forward, rotation of at least the plunger head and preferably plunger piston parts is prevented, which can be achieved by using any known guiding structures, such as a non-rotating symmetrical part interacting with its corresponding part, the parts being located on the plunger and case, respectively. The preferred transmission component for moving the plunger forward is a fixture with a spindle and a nut, one element of this pair being located on the plunger and the other located on the motor side of the transmission.

The necessary characteristics of speed, force and movement with respect to the plunger depend on a number of conditions, such as the nature of the container and the hole, the particular application of the device, for example, for surface or penetrating delivery, the viscosity of the preparation, for example, aqueous solutions or ointments, etc., and general regulations that cannot be given here. However, these energy sources, propulsion systems and transmissions can be adapted to each requirement. It was also considered useful to include a damper in the design, for example, a shock absorber, a linear shock absorber, a flow valve, a magnetic shock absorber, etc. to control speed while maintaining a stable effort. In most embodiments according to the invention, it is preferable to provide a rapid increase and decrease in pressure, which usually requires a stable and immediate speed of the plunger and which is facilitated, for example, by a damper or high inertia of the plunger and transmission.

It is also preferable to include devices in the device to facilitate tearing or removal of temporary sealing means (seals) located over the openings, as described. Although it is possible to tear the sealing means under the pressure generated by the subsidence of the rear wall, it is preferable to carry out an active operation to tear the sealing means. This can be achieved with a printing tool located in the housing, for example, a piercing tool for breakthrough sealing means and a peeling or pulling device to remove peelable sealing films. These devices can be located in or near the nest, for example, for action immediately before injection, or at some distance, for example, if there is no free space in the area of the nest. The printing tool may be operated manually or automatically or forcefully, for example, during movement of the container to the area of the nest. However, it has been found that it is preferable to position the printing tool behind the container to move it forward, which makes it possible to act on the film with the printing tool in the best possible way, that is, on the back of the film in order to lift it from the front surface of the front wall. This also allows the printing tool and mechanism to be positioned more conveniently inside the housing and behind the container in order to less intrude into the injection area and not interfere with the injection object, but most preferably the tool can be positioned on or connected to the plunger so that it moved with the plunger using one movement mechanism and to facilitate the removal of the sealing medium immediately before injection and as an integral part of the stage in sinking. For the above purposes, it may be preferable that the tool has its own movement mechanism. Preferably, the printing tool passes through an opening in the structure of the front wall and possibly also through the back wall at a point not occupied by the recess of the container, but covered by a sealing film. Preferably, the dimensions of such a hole and a printing tool can be adapted to each other to obtain a guiding action, as described, for the final alignment of the plunger and the recess before initiating the device. During operation, the tool first lifts the film from the opening of the container, and then the head of the pusher strikes the rear wall of the container. You can perform these two operations during one continuous movement of the plunger, for example, to simplify operation as much as possible and possibly print later, or during two operations that may require two actions by the user to initiate, for example, to enable the user to verify that the film is removed accordingly. It would also be of interest to use different motion characteristics for two operations, for example, slow motion for peeling, so as not to cause destruction or rupture, and fast action for injection, which might require some kind of shifting device, for example, for shifting gears, releasing the brake or damper, etc. The general principles of the container design, corresponding to the present invention, significantly enhance the above

3Ί advantages, among other things, due to the stiffness that allows the front wall to be used as a guide and allows the use of zones outside the recess without problems of instability.

As indicated, the device can be adapted for various use cases. Depending on the purpose of each option, it may be useful to provide the device with devices that facilitate aiming and positioning. For example, when the device is used to eject fluid into the eye, the device may have an eyecup as described above. Puncturing options may require a small distance between the hole and the surface of the object or direct contact between them and, possibly, devices for initiating a device with a specific contact pressure of the end element to the destination. The treatment of large surfaces may require a terminal element that defines both the angle and the distance.

Way

The above description is presented with links directly or indirectly to structural and operational features or follows from descriptions of structures, functions and goals. The invention should be considered as including and covering the described aspects of the device and method and their characteristics. Methodological aspects are not repeated here separately. Aspects of the method will also be described below in conjunction with the drawings. According to other aspects, an injection device according to the invention can be used in a conventional manner or according to the prior art.

Brief Description of the Drawings

In FIG. 1A is a perspective view with a spatial separation of parts.

In FIG. 1 B-1C shows a device in cross section during five working phases in an embodiment of the invention, driven by batteries and an electric motor, and using a disk having a plurality of containers for a single dose, designed to increase the pressure in them with a plunger.

In FIG. 1H is a detailed view of the components of the main lever.

In FIG. 2A-2C schematically depict in open form and in two sections, respectively, an alternative embodiment of a fully mechanical device that is designed for manual cocking.

Description of drawings

In FIG. 1A-1H show a device that uses a built-in electric motor to cock the pump mechanism while retracting the print pin with the final stepwise movement of the disk container, followed by the print pin moving forward to detect and ultimately remove the temporary seal in the form of a film located over the openings of the container .

In FIG. 1A is an exploded view of the components of a device. The device 100 comprises a housing 110 having an upper portion 111 and a lower portion 112, and an externally accessible trigger 113. The housing also includes a door 114 that can open when the eyecup is in a remote position to insert or replace a disk 116 with multiple containers 117 s openings 118 and openings 119 for peeling off the sealing means. The movable eyecup 120 comprises a rim 122 attached to brackets 124 that are connected at their other ends to pivots of the hinge axis 123 held by the supports 128 and 128 ', the latter having a cam part (not shown) that moves with the eyecup, while the cam part acts on sensors located on the inside, which will be described below. The housing also includes a window 124 above the display and a battery cover 125.

In the interior of the housing is located the upper part 126 of the mounting plate and the lower part 127 of the mounting plate, supporting the mechanism of the device. The specified mechanism includes a drive mechanism, indicated by the number 130, a transmission 140, a pump mechanism 150 with a device for storing energy charging, a print mechanism 160, a step mechanism 170 and a control system 180, including a panel 181 for electronic means.

The drive mechanism 130 includes an electric motor 131 with batteries (not shown) having a rotating shaft with a front encoder 132 for counting engine speeds and an external screw thread 133 for interacting with the initial gear in the transmission chain. The electric motor and the engine speed sensors are attached to the mounting plate 181.

Transmission 140 comprises a set of gears in a gear train designed to reduce the speed transmitted by the electric motor and increase the force, with adaptation for each function. The gear mechanism 142 of the printing mechanism is designed to drive the printing mechanism, the intermediate gears 143 and 144 are parts of gears without any additional functions, and the gear mechanism 146 of the charging mechanism is designed to actuate the cocking mechanism for the pump mechanism. These elements can also be seen in FIG. 1 N.

The pump mechanism 150 includes a lever 152, which can be rotated around the axis 153 of the lever, providing movement up and down of its end located on the end of the housing where the eyecup is located. At the other end of the lever is a means 154 for attaching to the damper. The means of attachment to the damper is connected to the piston part 157 of the damper, the cylindrical part of which is fixed. In the specified device, the piston moves, overcoming the action of vacuum, and passes air into the cylinder to slow the speed of impact of the plunger. The pump mechanism includes a plunger 158, rotatably connected to a lever at a point 159 and guided in a circuit board to provide a plunger to strike the deformable rear wall when moving in a substantially straight line. In the shown position, the movement of the lever 152 down from the eyecup is used to cock the springs 156 in the pump mechanism. The cocking springs are designed to eject the plunger when it is released in the direction of the container 117 for expelling the fluid through the holes 118. As can be seen in FIG. 1H, the lever has a nut 151 with an internal screw thread (not shown) for engaging with the corresponding screw thread with an external thread rotating together with the cocking gear 146 in the transmission. The nut is attached to the lever, allowing the lever to move up and down depending on the direction of operation of the electric motor. The nut is attached to the lever so that it only grasps when moving in the cocking direction, and not in the downhill direction. A spring-loaded L-shaped clamp 155 of the plunger is designed to move under the lever 152 in the cocked position to hold it until the descent. When the motor is turned on in the opposite direction, the nut can freely move from the lever in the direction of the descent until it collides with the lower arm of the L-shaped configuration, which releases the plunger lock and leads to the ejection of the plunger, and this will happen when the print pin 162 has reached its front position and, accordingly, completed printing of the sealing medium.

The printing mechanism includes a printing pin 162, which is secured with dowels at a point 164 in the circuit board to prevent rotation and has an internal thread 166 for engaging with the external thread of the printing mechanism gear 142 to allow it to be moved up and down by the motor. Obviously, in this embodiment of the invention, the electric motor and the transmission drive the print pin directly, rather than by charging springs or the like energy storage means. At the end of the forward movement, a pump mechanism is actuated for printing, ejecting the plunger by releasing the plunger latch 155, as described above. On the rear side of the gear mechanism 142 of the printing mechanism, a force-sensitive sensor 168 is arranged to turn on the signal when there is a certain reaction force that the printing pin must overcome when tearing off the temporary sealing means, which allows the control system to check its presence.

The stepwise movement mechanism 170 comprises a step gear 172 for interacting with a suitably configured hub of the container disc with the number of teeth corresponding to the number of containers in the disc. The stepping gear has a certain mobility and is loaded with a spring to facilitate connection with the disk. On the other end of the stepping gear there are serrated internal locking wheel 173 and external locking wheel 174. The incremental movement increment device is driven by the dowels 164 of the print pin 162, which, when moving backwards, act on the wedge-shaped surface 176 of the axial arm 175, which, in turn, acts on the radial shoulder 177, which engages with the internal fixed wheel 173, to rotate the stepping gear by one tooth. The spring loaded counter arm 178 is engaged with an external locking wheel to prevent the stepping gear from rotating in the opposite direction. The step movement corresponds to one tooth, and after injection, at each working cycle combines a new container with a plunger. This discrete step action is triggered when the print pin during its backward movement is in a position remote from the eyecup of the device, and in this position the pin is removed from the opening for printing in the disk, allowing it to rotate. This step is also monitored by a counting sensor (not shown) that provides a signal to the processor on panel 181, which negatively increments the displayed number corresponding to the number of remaining doses. The processor is also designed to prevent starting after all doses of the disk have been injected, or if a defective container is detected by moving the print pin to the farthest position, causing the door to open to replace the disk.

As noted, most electronic means are located on the mounting plate 181. In addition to these features 41, the control system 180 includes a display 182, also connected to the panel, and a door lock 183 with levers 184 that act on the door sensor 188 depending on the position the door. In addition, the sensors 185 and 186 interact with these cam surfaces in the support 128 'to determine the position of the eyecup. A switch 189 is mounted on the top of the circuit board 126, and the trigger 113 acts on it. A processor 187 is used to control the operation of the device.

In FIG. 1B-1P show various phases of operation of the device. In FIG. 1B shows the initial position immediately before the injection cycle. The print pin 162 is in the middle position immediately behind the film to be removed. It should be noted that the cocked springs 156 are already in the cocked state, with the specified cocking made earlier, during the movement of the print pin back, and the damper 157 is in its original position. In the touch position of the film shown in FIG. 1C, the trigger is activated, and the electric motor has moved the print pin a small distance in the direction of the point at which it passed through the hole 119 for printing in the disc and touches the film to check its presence by the sensor 168. In the peeling position of the film shown in FIG. 1Ό, the print pin 162 completed its forward movement and removed the film. In the injection position shown in FIG. 1E, in the most extreme forward position of the print pin, the plunger latch 155 is released, which actuates the plunger 158, which completed the injection in the shown position. The lever 152 has moved up in the right part of the figure under the influence of cocking springs 156 and down in the left part, stretching the piston of the damper 157. In the position of the beginning of the step movement shown in FIG. 1P, the device is re-cocked during the return movement of the print pin by reversing the motor, and the print pin is retracted further than in FIG. 1B, wherein the stepwise movement of the disk begins during the further movement of the print pin back. During the final part of the backward movement of the print pin, the stepwise movement of the disk will be completed. The next time the motor is reversed, the print pin can move forward to the initial position shown in FIG. 1B. In this position, the device is ready for a new injection cycle if the trigger 113 is pressed and if the eyecup 120 is in the shown operating position. Alternatively, as shown in the door open position of FIG. 16, the processor can move the print pin to a position even further backward than at the start position of the stepping movement shown in FIG. 1P, which will release the mechanical blocking of the door 114 to enable replacement of the disk, which will also require folding the eyecup to a remote position approximately 180 ° from the position shown. This will happen when all disk containers are used or if a defect is detected.

The use of the device will be described starting from the initial position in which the device is in the initial state shown in FIG. 1B. If the eyecup is in its original position (not shown), it should be moved to the shown operating position to initiate the device. The display may indicate a warning, for example, by a blinking light. The eyecup is placed opposite the eye and the trigger is activated, which is possible only when the eyecup is in the active position, and this will initiate the execution of the entire sequence of removal of the sealing medium, injection and step movement by force by performing the above steps until the device is brought back again to the state shown in FIG. 1B. Alternatively, actuating the trigger will cause the device to act until the film is completely removed, as shown in FIG. 1Ό. Then, a new trigger actuation will be required to complete the injection process, as shown in FIG. 1E, and automatically proceeding until their completion, as shown in FIG. 1B, or to the opening position of the lid shown in FIG. 16. The second actuation of the trigger mechanism will be carried out within a certain time interval after the first actuation, otherwise the processor will automatically continue the procedure until the end, and the dose will be lost. This is necessary to eliminate the risk of contamination of the container after opening. When all doses have been used up, the processor will drive an electric motor to move the print pin to its rearmost position, shown in FIG. 16, to replace the disk. After recognizing the fresh disk, the processor will move the print pin to the home position shown in FIG. 1B, and the dose count will be reset to zero.

In FIG. 2A-2C show a general view of a modified device compared to the device shown in FIG. 1, and the following description will mainly focus on differences. The device shown in FIG. 2, completely mechanical and intended 43 to be actuated by manual force, which is communicated to the device by manually pressing the eyecup while moving the eyecup from a remote position relative to the housing in the direction of the approximate position, while the energy is accumulated as the energy of charging the device springs. In FIG. 2, the device is shown in working condition before injection, that is, after the application of manual force, and when the eyecup is in its working position, namely, in readiness for injection.

The device 200 includes a housing 210 having an externally accessible trigger 212 connected to a trigger pin 214 and a locking pin 213. The housing also includes a door 214 that can open when the eyecup is in a remote position to insert or replace a disk 216 with multiple containers 217 with openings 218 and openings 219 for removing sealing media. The eyecup 220 comprises a rim 222 attached to an arm 224, which is connected at its other end to a hinge with a pivot axis extending into the housing and connected to its mechanism. The specified mechanism includes a drive mechanism, indicated by 230, a cocking mechanism 240, a pumping mechanism 250, a printing mechanism 260, a step movement mechanism 270 and a control system 280.

The eyecup bracket is connected to a partial wheel 232 of the drive mechanism, which through a “locomotive” connection 234 forcibly transmits the same rotation to the drive wheel 236. The drive wheel is connected to the cocking wheel 242 of the cocking mechanism 240 through a freewheeling system 238 designed to provide parallel rotation of the wheels when cocking the device by pressing the eyecup in the direction of the housing, but releasing the cocking wheel from the drive wheel when rotating in the opposite direction . The drive wheel has a protrusion with a groove 239, designed to interact with the locking pin 213 of the trigger so that the trigger and, accordingly, the eyecup can be pressed when the drive wheel is flush with the groove, which occurs when the eyecup is in the working position, but not when the locking pin is on a ledge outside the groove.

The cocking wheel 242 of the cocking mechanism is connected to a lever 244, which can rotate around a lever hinge (not shown), as in the embodiment shown in FIG. 1, which allows its end to move up and down on the side of the eyecup. The other lower end 246 is connected to the damper, as shown in FIG. 1. The movement of the lever 244 down from the eyecup in the position shown is used to cock individual springs in the pump mechanism and in the print mechanism.

The pump mechanism 250, essentially symmetrical with respect to the center line of the device, includes a pusher 252 and pump springs 254 designed to eject the pusher, when released, in the direction of the container 217 for injecting liquid through the holes 219.

The printing mechanism 260, also substantially symmetrical with respect to the center line of the device, includes a printing pin 262 and springs 264 designed to eject the pin when they are released in the direction of the disk 216 so that the pin passes through the hole 219 of the disk and thus removes temporary sealing film. The descent occurs when the transfer hook 266 is released by the action of the release button 212 using the release finger 214 and the intermediate gear rocker 268. When this happens, the cocking wheel is able to rotate in the opposite direction compared to the cocking direction. At the end of the print movement, a pump mechanism is actuated to eject the plunger.

The stepper movement 270 includes a stepper wheel 272 for interacting with a suitably configured hub of the container disc, here shown with 14 teeth corresponding to the number of containers in the disc. The stepper wheel is connected to a discrete stepper fixture 274 designed to rotate the stepper wheel and disc by an angle corresponding to one tooth. This step-by-step action is initiated when the print pin, when cocking the device, moves to its most distant position relative to the part of the device where the eyecup is located, and in this position the pin is pulled out of the hole in the printing disk and allows the disk to rotate. This action is also transmitted to the counting disc 276, which also rotates in incremental increments, showing a new digit corresponding to the number of remaining doses in the case window, as well as the gear wheel 278, which also rotates in incremental increments. The gear wheel has a stud 279, which, after issuing 14 doses, comes into contact with the transmission rocker 268, which disengages the transmission hook from the drive wheel, thereby allowing the eyecup to move to a remote position outside the active position and, in turn, allowing the door to open to replace the drive.

The use of the device will be described starting from the starting position in which the device is cocked and the eyecup is in a close starting position in which the trigger cannot be triggered due to the lock pin 213 being out of groove 239. The eyecup is moved to the active position, in which you can press the trigger. The eyecup is placed opposite the eye and trigger is triggered, which will initiate the entire sequence of printing, injection and step-by-step movement by force by the implementation of the above actions. When the trigger is activated, the drive wheel 236 is released, and thus the eyecup, so that the springs associated with the drive wheel will automatically move the eyecup to a remote position, deflecting it approximately 30 ° from the body, prompting the user to perform a cocking movement of the eyecup. The user presses the eyecup, moving it to a close starting position, which causes the device to be cocked and, at the end of the sequence of actions performed, causes the disk to move stepwise and the counter incrementally. The eyecup is locked in its initial position until it is actively moved to the working position to repeat the cycle. When 14 doses are used up, the eyecup is not fixed and can move to a remote position in which the door can be opened to replace the disk.

The invention is not limited to the described and shown variants of its implementation and they can be changed within the scope of the claims.

Claims (42)

CLAIM 1. A device for injecting a jet of liquid in the direction of the eye with the possibility of providing the jet from a near position in the direction of the far position, said device comprising a) a housing, b) a container for a liquid, c) at least one hole designed to inject a jet and communicating with the container by means of a jet of liquid, 6) a pumping mechanism adapted to deliver at least part of the liquid from the container through an opening to form a jet of liquid, and e) an eyecup with a con a contact surface intended to come into contact with the eye or its facial environment, characterized in that the eyecup may be configured to move relative to the opening or housing between at least two positions: I) an operating position in which said contact surface of the eyecup is on given a safe distance from the hole, and ii) an initial position at which the contact surface of the eyecup is in a position closer than the working position, and the sensor is with the possibility of recognition of these provisions. 2. The device according to claim 1, characterized in that the hole is fixed relative to the body when moving the eyecup. 3. The device according to claim 1, characterized in that the container is attached to the housing with the possibility of separation. 4. The device according to claim 1, characterized in that a plurality of containers for a single dose are interconnected and can be sequentially moved into an operating position relative to the pumping mechanism. 5. The device according to claim 1, characterized in that the eyecup is made with the ability to move at least one additional position, more distant from the body or holes than the working position. 6. The device according to claim 1, characterized in that the eyecup can be completely separated from the body. 7. The device according to claim 1, characterized in that the eyecup is made with the possibility of the implementation of translational motion. 8. The device according to claim 1, characterized in that the eyecup is made with the possibility of movement with rotation. 9. The device according to claim 8, characterized in that the eyecup is connected to the housing by means of a swivel. 10. The device according to claim 1, characterized in that the sensor is configured to generate at least one signal, and the device is configured to perform at least one action based on the signal directly or after processing the specified signal into a control signal. 11. The device according to claim 10, characterized in that the signal generation or processing includes at least one stage of mechanical action. 12. The device according to claim 10, characterized in that the formation of a signal or processing includes at least one stage of electromagnetic exposure. 13. The device according to claim 10, characterized in that the sensor is configured to generate a signal characteristic of a continuous number of positions of the eyecup. 14. The device according to claim 10, characterized in that the sensor is configured to generate a signal characteristic of the discrete positions of the eyecup. 15. The device according to claim 1, characterized in that the device is configured to issue at least one message received by the user based on the signal. 16. The device according to claim 1, characterized in that the device is configured to perform at least one working operation of the device. 17. The device according to claim 15, characterized in that the signal is used to unlock or block the pumping mechanism. 18. The device according to claim 15, characterized in that the initiation of the device is carried out while the eyecup is in the working position. 19. The device according to claim 15, characterized in that the signal is used to block, unlock and alert the container. 20. The device according to claim 15, wherein the signal is used to unblock or block the action to test the device. 21. The device according to claim 15, characterized in that the signal is used to unlock or lock the door of the device. 22. The device according to claim 1, characterized in that the eyecup is configured to move relative to the hole. 23. The device according to claim 1, characterized in that the eyecup is arranged to move relative to the body. 24. The method of operation of the injection device for injecting a jet of liquid, the liquid jet moving from a near position towards the far position, the device comprising a) a housing, b) a liquid container, c) at least one hole designed to inject a jet and communicating with the container by means of a liquid, D) a pumping mechanism configured to deliver at least part of the liquid from the container through an opening to form a jet of liquid, and e) a part intended for a predetermined distance to the destination point and configured to move relative to the opening or housing between at least two positions: I) the working position in which the specified part is at a given safe distance from the hole, and II) the initial position in which the part is in a position closer than the working position, as well as a sensor that ensures the recognition of these positions, characterized in that they move the part between the working position and the original position and vice versa, carry out the formation of signals characteristic of both the working position and the initial position, if necessary, carry out signal processing to obtain a control signal and use a control signal or signal to perform at least one operation with the container, the opening, the pumping mechanism or part. 25. A device for injecting a jet of liquid with the possibility of ensuring the movement of a jet of fluid from a near position in the direction of the far position, said device comprising a) a housing, b) a container for a liquid, c) at least one hole designed to inject a jet and communicating with a container by means of a liquid; D) pumping mechanism, including the drive of the pumping mechanism for storing energy of charging to start the pumping mechanism, driven to deliver at least part of the liquid from a container through an outlet to form a jet of fluid, and e) at least one initiation mechanism, functioning separately from the pumping mechanism, to initiate a fluid delivery device, characterized in that it contains a drive mechanism configured to convert a manual force or accumulated energy as in I) energy of cocking the drive of the pumping mechanism, and in II) directly applied or stored energy for the operation of the initiation mechanism. 26. The device according to claim 25, characterized in that the cocking energy is at least partially accumulated by one or more mechanical springs. 27. The device according to p. 25, characterized in that the drive mechanism is configured to receive manual effort. 28. The device according to p. 25, characterized in that the drive mechanism is configured to receive the stored energy. 29. The device according to p. 25, characterized in that the stored energy is electrical energy, preferably accumulated in batteries. 30. The device according to p. 25, characterized in that the drive mechanism includes a transmission. 31. The device according to item 30, characterized in that the transmission is made with the possibility of lowering the speed to increase the effort. 32. The device according to p. 25, characterized in that the initiation mechanism is made with the possibility of the message step movement, in which the container is transferred to the operating position relative to the pumping mechanism. 33. The device according to claim 25, wherein the initiation mechanism is adapted to initiate printing, in which the temporary sealing means is removed from the container. 34. The device according to p. 33, wherein the printing action comprises the step of moving the printing tool through a disk element having a plurality of containers. 35. The device according to clause 34, wherein the printing action includes the step of checking for the presence of temporary sealing means before its removal. 36. The device according to p. 25, characterized in that the drive mechanism is adapted to use the stored energy to control the initiation mechanism. 37. The device according to p. 25, characterized in that the drive mechanism is adapted to use the stored energy to directly control the initiation mechanism. 38. The device according to p. 25, characterized in that the drive mechanism is configured to start the cocking and the initiation mechanism, at least partially, sequentially. 39. The device according to claim 38, characterized in that at least two actions are performed by an initiation mechanism, and by the fact that at least two actions are performed, at least partially, sequentially. 40. The device according to claim 25, wherein the initiation mechanism is adapted to perform an inspection operation and / or an alert operation with respect to the container or opening. 41. The device according to claim 25, wherein the device includes an eyecup with a contact surface adapted to come into contact with the eye or its facial environment. 42. A method of operating a device for injecting a jet of liquid, wherein the jet of liquid moves from a near position towards the far position, said device comprising a) a housing, b) a container for a liquid, c) at least one hole designed to inject a jet of liquid and communicating with the container through a liquid, b) pumping mechanism, including the drive of the pumping mechanism, capable of storing coking energy to initiate the pumping mechanism, launched to deliver at least part of the liquid from the container through the outlet to form a jet, and e) at least one initiation mechanism, functioning separately from the pumping mechanism, to initiate a fluid delivery device, characterized in that the drive mechanism converts a manual force or stored energy as in I ) energy of charging the drive of the pumping mechanism, and in II) directly applied or accumulated energy for the functioning of the initiation mechanism.