HK1089355A - Liquid delivery device and method for operating an ejecting device - Google Patents

Description

Liquid delivery device and method for operating a spray device

Technical Field

The invention relates to a device and a method for emitting a liquid flow, in particular towards an eye, the liquid flow 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 configured to emit a flow of liquid and in fluid communication with the container, d) a pump mechanism operable to deliver at least a portion of the liquid from the container through the opening to form the flow, and e) an eyecup having a contact surface configured for contact with the eye or its facial periphery. The pump mechanism may include a pump driver that may store cocked energy for driving the pump mechanism, and there may be at least one actuating mechanism operable to activate the means for liquid delivery,

background

The means for ejecting a stream of liquid may have a variety of uses. Typical applications in the medical field include injection or infusion, body cavity treatment, intrapulmonary delivery, or body surface treatment such as topical treatment. Aspects of the present invention have particular utility in ophthalmology and, in particular, in the fluid treatment of the eye, for reasons which will be explained. Although aspects of the invention have broader utility, for convenience and unless otherwise stated, the invention will be described in this application.

Devices for delivering fluids, and particularly liquids, to the eye have long been used for a wide variety of purposes. A typical eyecup for comfort, refreshment or irrigation may include a cup having an anatomically adapted structure for submerging the eye. The delivery of large volumes of liquid, typically by means of sprinklers, has also been used for eye washing, for example in emergency situations. The present invention is primarily concerned with devices adapted to apply relatively small amounts of liquid to the eye, and devices which are sufficiently convenient to handle to facilitate or encourage frequent use, and in the case of self-administration. One common application is the administration of drugs to the eye. Generally, medical preparations are to be delivered in well-defined amounts to ensure delivery or absorption of a defined dose. An inappropriate physiological effect or excessive drainage due to the absorptive capacity of non-target tissues enters the laryngeal cavity through the nasolacrimal duct (tearchannel), or is inconvenient due to overflow onto the face or clothing, so a large residual amount is not allowed. Also due to the price of expensive drugs. For example, the treatment of glaucoma requires frequent daily administration of, for example, prostaglandins, beta-blockers or other expensive active ingredients which have effects in addition to the desired pressure relief effect when absorbed by body tissues other than the eye. In addition, proper small dosage administration is complicated by the inability of the active ingredient to enter the eye except through a limited area of the cornea. Although the device to be described herein may be used with any liquid for any purpose, the invention will be described primarily in terms of medical applications for convenience.

The above situation places stringent requirements on an apparatus for the above general purpose. The small amount of formulation required must be placed in the eye with great care so as not to cause the above-mentioned overdoses, spills, side effects and target errors. Usually the secondary step is also controlled, for example the start-up step and the control of the state of the apparatus and the preparation conditions.

These requirements can also be met with the simplest delivery devices when operated by skilled operators who can also initiate medically relevant corrective measures in the event of accidents and malfunctions. This is also the case when using complex devices, for example in a hospital environment. However, the general trend in therapy is to have patients themselves responsible for the administration of drugs, also in the case of children, the elderly and the disabled. Patients often develop some skill in long-term treatment, but less frequent dosing regimens also exist, often including emergency or patient maladjustment situations. Other unique problems in self-administration of drugs to patients, as compared to assisted administration, are the need for less suitable or often stressful positions, and the fear or experience of pain or discomfort that can affect the desired mode of medical action. In summary, especially self-administration of drugs requires more complicated devices to facilitate the injection procedure and to avoid or reduce the risk of errors. Patients who rely on daily or occasional administration of drugs also have a reasonable need for convenience and a device that is sufficiently self-contained to be carried in daily life. It is desirable, however, that this dexterity and convenience remain simple and inexpensive to allow for wide distribution and also to be included in disposable devices.

The prior art devices can only meet the above requirements to a limited extent. Devices with manually controlled pump mechanisms, each having characteristics of ease of use or compact form of transport, have been proposed in, for example, WO98/55059 and US 5607410. However, these devices for multi-dose containers have no special means/devices for self-control, e.g. in terms of the activation step or the liquid state. For some purposes, it is desirable to replace the manually operated pump mechanism with some sort of automatic operation, which typically involves the release of stored energy, such as for controlled start, trigger, force, speed, reset or sequencing. And high liquid velocity requirements may place special demands. Such medical devices are, for example, autoinjectors, which automatically perform liquid injections upon triggering, and jet injectors, which perform penetration by liquid velocity rather than by needle. It has been proposed in eye treatment to deliver this liquid in a very rapid stream for sufficiently rapid delivery to overcome the blink reflex and to enable delivery of very small doses, i.e. less than gravity-delivered droplets, by ejecting a controlled amount of liquid from a pressurized chamber through a narrow orifice. Devices of this type are described, for example, in WO96/00050 for multi-dose containers and WO96/06581 for single-dose containers and our co-pending application PCT/SE 00/01514. This disclosed solution is not optimal for use as a portable or hand-held device, both in terms of the nature of convenience and in terms of suitability for further automation.

There is therefore a continuing need for a simple and inexpensive spray device that can assist the user in various relevant processing steps, which prevents or corrects errors and provides an ergonomically convenient non-invasive product, particularly for self-administered patients. Although the invention may have more general application, it will be described below primarily with respect to this background.

Disclosure of Invention

A main object of the present invention is to provide a liquid delivery device which better meets the above-mentioned general requirements than the devices known hitherto. A more specific object is to provide such a device which is suitable for portable or handheld use. Another object is to provide a device that is easy to use and suitable for self-service treatment situations. It is a further object to provide a device which can be used for mechanized, rather than manual, operation of its liquid pump mechanism. It is yet another object to provide an apparatus having structure for initiating and/or controlling a procedure. A further object is to provide such a device which is suitable for automating or mechanizing its function. It is yet another object to provide a motorized device that saves energy and/or force. It is also an object to provide a device suitable for delivering liquid at high speed. Another object is to provide a device compatible with multi-dose or single-dose containers. It is a further object to provide a device suitable for use with one or more replaceable single-dose or multi-dose containers. It is also an object to provide a device having appropriate ancillary properties such as refilling, starting, controlling, cleaning, treating and manufacturing outside of the immediate treatment situation. It is also an object to provide a device as described above adapted to deliver a liquid to an eye. A further object is to provide an eye treatment device adapted for convenient and accurate delivery of especially small amounts of liquid. It is a further object to provide a method for operating the above-mentioned device and/or a method for conveying corresponding to the above-mentioned device.

These objects are achieved by the features recited in the dependent claims.

According to one aspect of the invention, the device is configured for delivering liquid to an eye and includes an eyecup configured to define a given relationship between the opening and the eye. By making the eyecup movable between at least two positions, an active position providing a safe distance between the opening and the eyes and a position closer to the opening, it is possible, for example, to make the device more compact in its inactive position, improve portability, and improve its hand-held features with increased space between the device and the face in operation and facilitate self-treatment. Making the changes with respect to the opening facilitates its precise orientation, is important for delivery accuracy, and facilitates its integration with the housing and pump mechanism, e.g., eliminates the need for long conduits therebetween, more compatible with high pressure delivery. If a sensor or other device is used which identifies between the positions, the device function can be adapted accordingly, for example, generating a signal, actuating an electronic or mechanical device, locking the device, etc. Other locations for the eyecup may be added without sacrificing otherwise, such as for resetting, refilling, etc. A removable structure may also readily extend into a fully removable structure, for example to facilitate cleaning or to allow for replacement or selection between different eyecup shapes or sizes. This ability to move is compatible with increased functionality when not only the eye cup position, but the motion is critical. For example, the device may be actuated to move the eyecup to an active position when the activation or control has been successfully terminated or the device may act as a passive receiver of one motion input, for example by using motion for energizing (arming) or firing a mechanism in the device. Obviously, the functions described may be used to facilitate automated or mechanized capabilities in the device. Similar advantages can be obtained in other applications than eye treatment if the dedicated movable part can be moved in a corresponding manner.

According to another aspect of the invention, the device comprises an actuating mechanism operable to activate the container or opening for liquid delivery, and a driver designed to convert manual or stored energy into cocking energy for the pump driver of the pump and into energy for operation of the actuating mechanism. The use of a cocking mechanism for the pump driver means that the user may not operate the pump and may improve the timing, profile and target accuracy of the spray and allow any pump force, reservoir pressure or liquid velocity to be generated. The use of the same drive mechanism, also for actuation, simplifies the operation of the manual device and reduces the complexity in the automatic device. The activation step is common in delivery devices and comprises, for example: moving a new single dose container to the ejection site, opening a sealed opening, mixing the formulation precursors, breaking breakable walls or safety features, dose setting, degassing of the container contents, arming or releasing safety settings, etc. The present invention is applicable to any such start-up step or combination of the above. All possible activation actions may also make the device suitable for single-dose or multi-dose containers with single or multiple container structures and fixed or exchangeable. If the two transitions are separated in time or sequence, the peak force or energy requirement may be reduced. The same is true when two or more activation steps are similarly separated. This arrangement is useful in both cases where the drive mechanism directly operates the actuation mechanism, or where the drive mechanism provides stored energy to a firing state for the actuation mechanism. The principles improve ease of use by reducing the number of processing steps required. They also increase safety by allowing the inclusion of control steps and sequences of control between steps. The mechanization and automation of the device is facilitated by the combined operating action and the possibility of reducing the effort and energy requirements. For similar reasons, the device mechanism can be made simpler and less bulky, thereby improving its portability and hand-operability.

Further and more specific objects and advantages will be apparent from the detailed description below.

Definition of

Unless specific details are set forth, whether described, claimed, illustrated or embodied as one or more devices/arrangements, methods, uses, or combinations thereof, the term "system" as used herein is intended to be broadly construed as indicating the principles of the invention.

As used herein, expressions such as "comprising," "including," "having," "carrying," or "with," are not to be construed as limiting exclusively to the enumerated apparatus elements, composition compounds/ingredients, or method steps, but rather as permitting the presence of other elements, compounds/components, and steps, unless expressly stated or clearly contradicted. It should be understood to encompass any device elements in integral, subdivided, or aggregate form, and express methods such as "connected," "mounted," "disposed," "applied," "between," and similar terms, should not be construed as exclusively direct contact between the enumerated elements, but rather as permitting the presence of one or more intervening/intermediate elements or structures. The same applies to similar expressions when used to describe forces or actions. Similarly, absent express methods are to be understood as encompassing the compounds/components of the compositions in any physical or chemical aggregate or mixture of intermediate compounds/components possible, or the aggregate state and method steps in any temporal order, in the absence of explicit statements or explicit contrary conditions.

Also as used herein, positional and directional descriptions for the container or delivery device, such as "axial," "distal" and "proximal," "front" and "rear" and "forward" and "rearward," are understood to refer to the direction of liquid delivery, with respect to which a line centered on the container opening and drawn along the primary or general direction of delivery is considered the "axis" of the system along which liquid is delivered in a forward direction.

Also as used herein, the term "manual" in connection with a force or energy used to control the device is understood to mean that the operator applies the force or energy, directly or indirectly, in a manner that controls the process of the concept. Although servo assistance is hardly required or only preferred, it should be understood to include servo settings as long as the operator's action determines his performance, wherein force or energy from a source other than the operator, such as energy stored in a spring, gas or supplied energy, is used, in whole or in part, to assist in the process drive. In contrast to a "trigger" action, which may be an on/off action, a manual action has a functional relationship with position in the process, at least in part or to a limited extent.

Detailed description-overview

The devices described herein may be used for a variety of purposes within or outside the medical field, as well as any type of formulation, such as a chemical (drug), component or mixture, in any container and delivered for any purpose. For the reasons mentioned, the system has a certain special value in medical delivery devices, where design constraints are also more stringent than in most other applications. The invention will be described in this application for convenience.

Typically the material to be transported is a fluid and preferably a liquid, including materials which behave like liquids such as emulsions or suspensions. They relate to the final formulation, while other ingredients, in particular solids, may be present before the final formulation. Although pharmaceuticals are typically factory prepared, the nature of the contents of the container should also be understood to include pharmaceuticals in a broad sense and to include, for example, natural ingredients and pre-filled (pre-filled) or body fluids drawn into the container.

The principles of the present invention may be applied to a broad range of delivery devices or systems. A delivery conduit from the device may be an infusion channel or any conducting device such as a tube or catheter, needle or cannula or needle-free system based on liquid injection or drip gun (drop gun), or spray/emitter with/without a gaseous propellant. The container contents material may be delivered by a delivery mechanism, also referred to herein as a pump or pump mechanism, and any material that meets this requirement may be used. Typically the material is a fluid and preferably a liquid, including materials which behave as liquids such as emulsions or suspensions. They relate to the final formulation, while other ingredients, in particular solids, may be present before the final formulation.

The invention can be applied to fixed or permanently arranged delivery devices. For the reasons explained, the invention offers particular advantages in terms of delivery devices for walking/streaming (album) purposes, especially those having self-contained energy storage, motor and processor means, and especially small handheld devices that are truly portable.

Shell body

The device housing will be understood broadly and primarily represents a reference point for movement, unless otherwise stated, and also a reference point for the force exerted by the actuating means performing the above-described movement, where the force is applied between the housing and the moving or clamped part. The movable part may be present in the pump arrangement or in a part that performs, for example, mixing, automatic penetration, needle ejection and extraction, etc. The minimum functional requirements are: the housing provides a support or platform for the movable member and the actuating means that provides the motion and force. Such movable components may be present in the pump mechanism, in its driver and firing settings, and in the activation structure and its actuation mechanism herein. However, in common practice, it is preferred that the housing forms a container that at least partially encloses the components, and preferably to the extent that only the component that is designed to be controlled or monitored by an operator is exposed. In this context such exposed components may include a manually operated button for performing or triggering the ejection, a door to the receptacle for easy replacement, a display for displaying a message to the user, etc.

Container with a lid

The container is to be broadly construed and may take a variety of forms such as any of a variety of tubes, receptacles, flexible bags, vials, ampoules, cassettes, carpoules, syringe bodies, and the like. Common container materials may preferably be used, for example glass or plastic. The container may be of unitary or unitized construction, e.g. comprising a housing chamber or any other multi-part construction for closure, securing, protection, etc., and as used herein "container" will be understood to encompass any auxiliary component present. The container may be made integral with the housing, e.g. for use in a disposable device, when the container is refillable or when the container is part of a pump system which repeatedly draws the formulation to be injected from an external source or channel before each injection stroke. The container may also be separable, for example to allow replacement in the case of a disposable pre-filled container, for simple sterilization or disposal in the case of a change in the type of contents or patient. As is known per se, there may be more than one container, for example where it is desired to withdraw a portion of the volume from each container to mix prior to injection or to mix at the time of injection, or where different components are injected sequentially.

The container has at least one opening, also called orifice, through which the drug passes during the main delivery operation of the device, either from the interior of the container to the surroundings for administration to a patient, for example, or to the container in the case of aspiration of body fluid or during a preparation step, such as filling, mixing or dissolution in the container, during which operation an opening must be present. Possibly and even preferred in many cases, some device operations such as activation are carried out before communication is established, the opening requirements will then be considered to be satisfied by the preparation structure for establishing communication, such as a removable closure or pierceable or breakable part present on the container itself in the case of an ampoule or a bag, or a specially designed part in the case of pierceable membranes or diaphragms. All communication can be made through one opening, e.g. drug passage and pressure equalization in a rigid container, or by delivery from a container that is flexible or has a movable or deformable part, but it cannot be prevented that more openings are provided that can be identical to the at least one opening but also completely different for the same purpose, and that can be adapted for another purpose, e.g. for infusion or for syringe types with a movable wall or piston.

The delivery device is designed to continuously or intermittently withdraw metered amounts from the container, which may be a simple bottle, vial or bag, for defined delivery. In general, and in particular in connection with self-administration, the container type is more sophisticated and is usually in the form of a cassette and serves as a syringe type container part of the delivery system, and in the case of multi-chamber cassettes is more sophisticated. The cartridge will be further described below as they generally require additional activation or control steps for which the principles of the present invention may be advantageously employed.

A cartridge for this purpose generally comprises a receptacle (vessel) having a front part and a rear part defining a general cartridge axis, an outlet for the preparation provided on the front part, and at least one movable wall provided on the rear part, a displacement of the wall causing the preparation to move towards or to be ejected out of the outlet. The reservoir shape and the movable wall need to be adapted to each other. The reservoir may be designed most freely when the wall is a flexible or oversized membrane or diaphragm that can be adapted to the inner surface of the reservoir by the movement or reshaping, in which case a fluid cushion (cushion) or resilient material may be required between the wall and the piston rod to relieve the applied pressure. Preferably, however, between the front and rear members forming a generally tubular reservoir, the reservoir has a substantially constant internal cross-section having an equally constant reservoir axis and most preferably the cross-section is of the general ring type forming a generally cylindrical reservoir. The movable wall is then preferably a substantially form-invariant, though possibly elastic, plunger of the self-stabilizing type whose body sealingly fits to the inner vessel surface and is preferably of sufficient length to overcome the rollover as it travels along the vessel. The front member outlet may be of any known configuration and directed laterally to create the best path in some applications, it may also be forward but not coaxial with the reservoir or most generally forward and coaxial. The outlet may be integral with the reservoir or the cartridge front end may have a fitting in a conventional manner, thus having a breakable or penetrable seal prior to connection.

Generally, the above-described cassette requires a number of actuation actions depending on the displacement of the movable wall in order to reset the device and to enable repeatable and repeatable doses to be dispensed with the need for high precision. In its first such movement, the movable wall may require a special break release (break lose) force after storage to overcome two forces, namely the internal deformation resistance and an increased wall friction due to adhesion or loss of lubricant at the contact point. Also, the amount of elastic and inelastic deformations and tolerances must be leveled at the movable wall, the cartridge housing chamber, the outlet attachment, etc. with respect to the weaker regular injection forces. The formulation itself may have compressible inclusions (inclusions) such as air bubbles. Degassing and pre-blowing are required to remove the gas in the reservoir compartment and fill the interior space, e.g., in the front seal, outlet fitment and outlet device or needle.

Two or more chamber cartridge types are known, for example, for formulations requiring the mixing of two or more ingredients or precursors prior to administration. The components are held apart by one or more intermediate walls of known different types which divide the reservoir into a plurality of chambers, the walls sometimes being arranged in parallel along the axis of the cartridge, but most often in stacked relationship along that axis. The incorporation of ingredients may be carried out, for example, by breaking, penetrating or opening a valve structure in the intermediate wall by introducing a pin or needle through the front end of the cartridge, through or to the movable wall behind, or by means outside the cartridge (cf. for example WO 93/02720). In another known construction, the intermediate wall is of the plunger type and the liquid communication between the chambers is achieved by moving the plunger to a bypass portion, where the inner wall has one or more enlargements or repeated circumferential grooves and ridges which allow the contents of the rear chamber to bypass to the front chamber upon displacement of the rear movable wall (compare e.g. US4.968.299 or WO93/20868 and WO 95/11051). The chamber may contain a gas, liquid or solid. At least one liquid is typically present. Most commonly there are only two chambers in pharmaceutical applications and typically contain a liquid and a solid, the latter being dissolved and reconstituted during the mixing operation.

The activation of the multichamber cartridge, although in a complex form due to the presence of additional walls and spaces, requires all the general types of steps described above. In order to provide efficient mixing, a mixing space is usually allocated in addition to the space occupied by the component volumes. Powdered components in bulk form also require additional space to be contained within the interstices between the particles. This mixing step can produce a foam or gas inclusion that requires space to handle. The plunger type intermediate wall typically needs to move at least its own length to reach a non-sealing point in the bypass path. In general, multi-chamber cartridges require long movable wall strokes during the start-up step for mixing and subsequent degassing, and benefit in a particular manner from the advantages of the current invention.

The containers exemplified generally may be used for single or multiple doses to be ejected. In medical applications, multi-dose configurations often involve the risk of contamination of the container contents after opening and first use or of no longer maintaining sterility, which requires preservatives in the formulation. These problems can be avoided by a single-dose container that is opened in connection with the ejection operation and then discarded. For cost reasons, simple and inexpensive single-dose containers with one opening and at least one soft or deformable wall have been proposed, so that the container contents can be pressurized by squeezing or impacting the deformable member. Various directions of pressurization may be used, such as perpendicular with respect to the opening axis, although it is generally preferred to use a direction parallel to and preferably coaxial with the opening axis in the direction of advancement. These containers have been proposed for various delivery purposes, such as for needle injection as exemplified by FR1538565, for penetrating jet injection as exemplified by US2642062, US3419007 and US5026343, and for eye treatment as exemplified by WO96/06581 and our co-pending application PCT/SE00/01514, described in the introductory part. This type of container may be used for this purpose and the most preferred construction is that described in the above-identified co-pending application. Such a container may comprise a front wall having or enclosing a cavity in the form of a corresponding open receptacle, an opening in the front wall adapted to eject liquid from the container, optionally a seal over the opening adapted for temporary use, and a rear wall closing and sealing the open portion of the front wall receptacle to close a space for liquid in the container, the rear wall being at least partially perpendicular to the container axis and being movable or deformable for movement towards the opening to pressurise the container liquid. The front wall is substantially rigid relative to the rear wall, the rear wall is substantially flat or substantially single curved prior to pressurizing the container, and the rear wall is deformable under stretching to substantially fill the container cavity. The pump mechanism for such containers may include a plunger that presses or impacts on the flexible or deformable wall, as will be described in more detail below.

Although the above concepts are applicable to a single container for single and different uses, it is preferred to provide a multi-container unit or assembly. This may be for example by joining a plurality of individual containers into a multi-container structure by means of flexible connections, so that the structure may be bent, folded or rolled up. Preferably, however, the multi-container assembly is substantially rigid and is a self-supporting structure, wherein advantages are provided in relation to the delivery device. A rigid structure can be obtained by connecting the individual containers by rigid connections, but a preferred way is to exploit the rigidity of the front wall by providing an enlarged front wall structure, in which a plurality of chambers are provided, wherein the manufacture of the multiple containers is facilitated and a smooth and uncomplicated appearance is allowed. By utilizing these properties, which make the front and/or rear surface of the front wall structure flat or single curved, the film connection over these surfaces is further simplified, especially when the container surfaces lie in the same plane, since an undivided sheet material can be connected to a plurality of and preferably all individual containers of the structure, for example a common foil connected as a rear wall to the rear surface of the structure, or a common peel-off sheet over the container opening of the front surface.

The overall shape of the front wall structure of the multi-container may take a variety of forms, but a substantially flat front wall structure has advantages in terms of manufacturing and conveyor design. The shape may be, for example, rectangular, square, or circular. It has been found that a circular "disc" shape is particularly advantageous, wherein the absence of any particular starting position facilitates the handling and counting structure and allows self-centering properties when the sequential feeding of the containers to a delivery device, which can be realized by simple rotation in a "carousel" manner to one ejection position.

Most container types can be provided in a multi-piece construction if desired, and an activation step for any such construction can include the step of bringing a new container to an effective ejection location of the delivery device, or to a new container location.

As indicated, it is preferred to seal the container opening temporarily before actually ejecting the liquid to maintain a completely sealed container. The seal should be broken or removed just prior to use. Although a manually or pressure breakable seal may be used, it is generally preferred to use a removable/detached seal to avoid any particles falling from the seal, to have a fully predictable dynamic behavior, and to allow the use of more reliable thick or strong layers. Typically one seal may be integrally formed with the front wall, for example by moulding, to leave a membrane material somewhere in the open channel. Preferably, however, a separate release layer is provided for removal prior to ejection, and is preferably attached to the front surface of the front wall. Preferably, gluing with glue or adhesive is avoided and preferably some form of welding is used, like by ultrasound or heat. To facilitate removal and interference with the open area, the seal may be made as a limited area around the opening. In a multi-container configuration, the layers are preferably removable for each container, for example by using individual films, pre-cut films or individual tongues, for example in a star shape for one disc. The same considerations apply for the material of the membrane, although the membrane need not be deformable by stretching, and the requirement for impermeability may be somewhat reduced in view of the small open area. One actuation step for such a container may be to remove the temporary seal prior to ejection.

Opening of the container

The opening configuration may vary depending on the nature of the liquid stream to be produced, e.g. a nebulised spray or a stream of liquid collected to remain coherent/continuous or broken up into a linear stream of discrete droplets. Also the velocity of the fluid stream can be varied from high penetration to low impact surface delivery. Several or more openings may be provided, for example to produce a controlled spray, although it is preferred for most applications to use a single opening. The geometry of the opening may be a simple tube: e.g., divergent for assisting a distributed spray; for example polymeric, to aid in the flow of the binder liquid to be formed; or a combination, such as a venturi-type passage. It is generally preferred in high speed applications to make the duct section of the opening short to maintain low flow friction. Although the opening may be flexible, as in the case of infusion tubing, advantages in terms of accuracy may be obtained if the opening structure is rigid. The opening itself can be connected to the container via a tube, for example in the case of a feed tube, although the opening can preferably also be connected directly to the container. The opening is described herein as an end point suitable for delivery of the formulation to a target site, for example on or in a patient, for which purpose at least the last, foremost part of the conduit should be suitable for delivery to that site. Depending on the delivery mechanism used, the front end may not be designed to be in direct contact with the target site, for example in the case of a liquid spray, where the front end may be an orifice or opening for positioning at a distance from or on the surface of the target, although the actual target is below the surface. In other cases, the leading end is designed to penetrate a target, such as in the case of a cannula or a common needle. Such as a flexible infusion tube or in a self-contained permanent connection, the passageway between the front and rear ends may be curved or bent, although in many applications it is desirable for the tubing to be substantially straight, such as the needle of a syringe.

Pump mechanism

The mechanism for delivering the medicament through the container opening should basically comprise at least one type of pump mechanism, which needs to be selected for the particular type of container and medicament used. The pump mechanism may comprise any type of pressure source, such as mechanical or electrolytic pressure build-up, in a container and suitable valves for control, and the method may be used with any type of container and any type of product, such as subcutaneous infusion by liquid jet as exemplified in WO94/2188, or common tube infusion as exemplified in WO 88/09187. Any type of container may also be used with pumps based on peristaltic or centrifugal action, although pumps based on controlled effective displacement are preferred for general use, and especially those based on a separate cylinder and piston action, such as for liquid spraying as exemplified in US5480381 or for a device based on a manually operated needle as exemplified in US 4564360. This common syringe type container requires a special pump system. Or the mechanism is adapted to act on a complete syringe with its plunger rod by engaging and axially moving said plunger rod, as exemplified in US4978335, which is preferred when it is desired to accommodate a variety of different types and sizes of syringes; alternatively, the mechanism has a piston rod which acts more or less directly on the piston of a cassette container, as exemplified in WO95/26211, EP143895 or EP293958, which container can be made smaller and more suitable for portable devices. Also, a two-or multi-chamber cartridge may use a similar device for its different stages, as exemplified in WO 93/02720. Although the various pump mechanisms discussed may include mechanical structure for acting on the drug or a piston, such as a piston rod, they may be actuated by any known means, such as pneumatic, vacuum, hydraulic, spring, or manual operation.

The mechanism may preferably comprise some further components. The mechanism may for example comprise special structure for ensuring the delivered dose, e.g. by directly metering the delivered drug, although it is generally preferred to use the pump mechanism directly or indirectly, e.g. by monitoring the axial displacement of a piston rod or its rotation in a manner known per se.

The pump mechanism may also include a manual control mechanism that provides an interface between the user and the actual pump motion. In the case of stored energy, the control mechanism may take the form of a trigger that releases, for example, a valve or mechanical lock. In the case of manual operation, the control may take the form of an actuator which performs the pump movement directly or through a linkage system. Preferably a connection system comprises a lever mechanism which can be used to reduce the manual force applied when, for example, the formulation is too easy to be expelled or when a reduced stroke length is desired, but preferably to amplify the manual force or increase the stroke length for the actuator. The manual control mechanism may include conventional safety features such as a cocking lock or operating requirements to prevent inadvertent operation by a child.

Another known pump mechanism is to pressurize a small liquid chamber by rapidly and partially heating the liquid to form a vapor or by compression by a piezoelectric element. Alternatively, the liquid adhering to the surface is thrown out by surface vibration instead of being pressurized. This technique is used for delivering small droplets in rapid succession, for example in inkjet applications, but has also been proposed for therapeutic purposes. WO96/06581 and EP224352 mentioned earlier disclose piezoelectric elements and electrostatic devices for eye treatment, vibration techniques are disclosed in EP615470, US5518179 and US5838350, and bubble jet (bubble jet) techniques for eye treatment are disclosed in WO 94/03135. The pump mechanism may be used for this purpose, particularly for delivering small droplets as is sometimes desirable in eye treatment. In medical applications it is desirable to use this technique in combination with single dose containers, for example to better maintain the above-mentioned sterility.

When applying the present invention in connection with a pump drive using percussion energy, it is preferred to use a pump mechanism that uses a relatively high force or high effect, since the device benefits especially from the percussion advantages, such as the possibility of using a rather weak motor or manual input to be stored in the percussion structure. It is also preferred to use a pump mechanism built on a rather simple movement pattern, e.g. a rotational or preferably translational movement, e.g. when using a plunger rod as in a suction/ejection system for pressurizing the above-mentioned flexible or deformable container or piston/cylinder type structure, or a piston in a syringe type device.

Energy may be stored in the firing structure in different forms, such as electrically or magnetically, although it is preferred to use pressure, such as in a gas or hydraulic spring, and most preferably mechanical energy, and preferably mechanical energy of a mechanical spring.

Likewise, the energy input into the drive mechanism may take a variety of forms. The energy may be manual. Alternatively, energy stored in any form, such as the forms described above, may be used, although the energy is preferably electrical energy delivered to the device, such as from the outside, or preferably in an on-board battery, to be converted by any electromechanical device, such as a solenoid or preferably an electric motor.

Preferably, an actuator, for example to vary the force, may be provided at a location between the energy input device and the pump structure to divide the energy for the activation steps or to influence the sequencing. Typically, the actuator involves a step of deceleration from a lower force to a higher force. The driver may be implemented after storing the firing mechanism energy, but is preferably implemented before storing to generally allow the energy storage to provide a force greater than the input force. Any known mechanism for force modification may be used, such as a lever arrangement, a lead screw and nut arrangement, or a gear train arrangement.

Starting up

As mentioned above various container types may require different actuation actions. For example, a syringe-type container may require an initial piston movement for various reasons, such as mixing of precursor components. A piston/cylinder arrangement may require aspiration from a vial or feed tube. A multi-container configuration may require a new container movement to an effective ejection location, also referred to herein as counting (indexing). Removal of the temporary seal, also referred to herein as peeling, may also be required. All possible starting steps should not be repeated here.

Additional startup steps may include control steps performed to avoid faults or to ensure that all conditions for successful operation are present. Such a control step may be checking for the presence of a container in a container seat, checking that the container is still used, i.e. not empty, checking for the presence of a temporary seal before its removal, checking for the correct position of the door, closure, eyecup, etc. Such a control step may be used to prevent triggering or issuing a warning until all required conditions are met. Some of these control steps may be performed by a micro switch or simple mechanical lock or catch (catch) for the above-mentioned activation steps, but to some extent these controls require movement of a component that requires significant force or power, which steps may be fired as the following activation steps.

Although this activation step may be performed manually or by a separate drive system, for some of the reasons described, it may be advantageous to use the same drive mechanism for not only the firing step but also for at least one activation step. Depending on the force requirements in the activation step, in the same way a deceleration force increase and possibly a firing structure for activation are required for the pump drive, and possibly the same structure can then be used for both purposes. Alternatively, if the force or speed requirements are not large, for example, the step may be driven directly without the firing settings, and an up or down drive or no drive may be employed. Typically the two motions require different motion characteristics or are used for different components, requiring at least some of the different components in the actuator mechanism, which is often preferred.

Regardless of the drive mechanism sharing approach, there are a number of alternatives for the sequence of actions. This firing action and at least one firing action, such as firing and counting, that may be performed simultaneously or at least partially, such as to save time between operations, for example. The simultaneous action may be performed either due to movement of the same components for both purposes, e.g. when having one firing system for both purposes, but preferably involves different components of the driver mechanism. In most cases time is not critical and it is preferred that the actions are performed at least partially in sequence, for example to reduce the force and power requirements of the drive device, which is of particular value for portable devices. More than one actuation step, such as counting, stripping and controlling, is involved in the device use cycle, and then preferably at least two or more actions are performed in sequence to enhance the advantages described above.

Some sequencing may be achieved without any active switching action performed by the mechanism. For example, a single movable element may carry both a plunger or ram for ejection and a stripper pin further forward to ensure that the stripper pin arrives before the plunger enters the ejection operation. It is also possible to obtain different arrival times without arranging components on or being driven by the same component of the driver mechanism. However, some switching means for sequencing is usually required. Typically, the driver system needs to be disconnected from the firing structure. This may be accomplished by locking the firing structure in its fired state and releasing the mechanism by disconnection for continued movement or by reversing the motor rotation. Similar actions including different arrival times may be used for the sequence between the multiple launch actions.

Operation control

The operation of the device may include the steps required to eject the liquid, the actuation steps and the control steps when present, and any interaction thereof such as the sequencing described above. Control may be entirely by software means for maximum flexibility if the current actuation architecture is sufficiently complete to be able to drive the various components in the motion it is intended to achieve individually, such as separate motor devices and solenoid operated locking and blocking structures. Sensors or micro-switches may also be required at strategic locations of movement in order to ensure operation in the correct spatial relationship between the components. The control of these components may be performed by electronic means, such as a microprocessor provided with suitable software.

However, for maximum safety of operation, it is generally preferred to provide mechanical structural assistance control, and this may also be necessary when the same motor arrangement is to be used for different purposes-such as the firing and starting steps of the above example. Mechanical switching means can easily be provided to be triggered by a moving part at a critical location. The combined use of software and mechanical structures for maximum safety and operational redundancy is not prevented.

Even if the primary device function is controlled mechanically, it may be beneficial to include electronic components for various secondary purposes, for example for issuing an alarm, for example by light, sound, vibration or display messages, or sending an alarm or instruction message to the operator, for example. The control of one display may also be used to inform the user of, for example, the time relationship between (two) administrations, the doses remaining in the case of a multi-dose container or a plurality of single-dose containers, the device status, etc. A processor and memory may also be used to memorize time and dose administered, e.g. for control according to prescription, and possibly also the data may be downloaded from the device, e.g. via an Infrared (IR) connection from an on-board erasable programmable read-only memory (EPROM), for further processing in external equipment.

The various drive means may use various known forms of stored energy, such as electrical energy, gas pressure or gas relief, or preferably mechanical energy, the latter preferably being in the form of a resilient element such as a spring. The stored energy can be converted into the above-mentioned forces by corresponding conventional, e.g. electromechanical, transmission means, such as electric motors or solenoids, hydraulic, pneumatic, etc., but preferably using mechanical springs.

The use of sensors and signal processing in the device will be described in detail below in connection with the mobility of the eye cup for the device, as the general principles given below apply equally to the other components of the device.

Use of

The features of the invention as described above have wide utility and may be used in a wide variety of applications. The present invention has particular utility in applications where it is desirable to replace a manually operated pump mechanism with some sort of automatic operation, typically involving the release of stored energy, for example for controlled actuation, triggering, force, speed, resetting or sequencing. The invention also has particular utility in applications requiring high liquid velocities. Such medical devices are, for example, autoinjectors, the liquid injection of which is carried out automatically after triggering, and jet injectors, the penetration of which is carried out by means of the speed of the liquid rather than by means of a needle. It has been proposed in eye treatment to rapidly deliver liquid by ejecting a controlled volume of liquid from a pressurized chamber through a narrow orifice, fast enough to overcome the blink reflex, and to allow delivery of very small doses smaller than those delivered by gravity. The application of this eye treatment will be further explained below.

Eye treatment

One preferred application of the invention relates to the ophthalmic treatment of the eye by means of drugs. The usual way of administration is via eye drops or ointments, which however have some disadvantages. Both of these modalities typically deliver higher amounts than can be absorbed by the eye, resulting not only in dose uncertainty and loss of expensive therapeutic drugs, but also in possible side effects when the unabsorbed formulation is drained through the nasolacrimal duct, such as the substantial systemic effect of beta-blockers used in eye treatment. Another problem is that common methods of administration tend to cause a blinking reflex that may completely destroy the treatment or at least introduce a high degree of uncertainty. Moreover, this conventional method does not provide a high degree of positional accuracy, such as the ability of the prostaglandin to hit the portion of the iris that is the penetrable portion of the eye. The principles used in the present invention address these issues: among them by the possibility of delivering small volumes of liquid that are actively ejected, rather than determined by the surface tension of the liquid, by the possibility of delivering liquid with sufficient velocity to overcome the blink reflex, and by the possibility of ejecting a focused and continuous stream of liquid for precise target localization. Although the invention is not to be considered limited to any of the exemplified parameters, typical parameters for the application will be given below. A typical single dose volume for delivery to the eye may be less than 25 microliters, preferably less than 15 microliters and most preferably less than 10 microliters. Typically the volume is at least 1, preferably at least 2 and most preferably at least 3 microliters. Since it is desirable that each container contain a single unit dose, the data also relates to the volume of liquid contained in the container, possibly allowing some overfill, e.g. 25% overfill but preferably not more than 10%, to compensate for non-squirtable amounts, e.g. liquid left as a wet film or in the open tube of the container. Although in many cases little or no gas is present, the container may contain other materials in addition to the liquid, particularly a gas such as air or a purging gas such as nitrogen or an inert gas, for example to facilitate manufacture, to assist nebulisation or to act as a pressure buffer. The velocity of a suitable droplet stream or jet should be balanced between: that is, on the one hand, without gravity assistance, has sufficient linear momentum to cross the gap between the opening and the target and proceeds fast enough to be unobstructed by blinks; and on the other hand not so fast as to cause an impact that is unpleasant to the eyes. The ideal velocity depends to some extent on the size of the droplets used, but in general the droplets should be able to pass through the air with their own momentum by at least 1 cm, preferably at least 3 and most preferably 5 cm, which comprises a reasonable distance between the opening and the target. A suitable lower speed limit when leaving the opening is 1 meter per second, preferably at least 5 meters per second and most preferably 10 meters per second. Typically the speed is below 200 meters per second and preferably below 100 meters per second. A droplet so defined should be of a suitable size that it is not slowed down too quickly and is not easily redirected, e.g. sucked in, and preferably has a minimum diameter of 20 microns, preferably not less than 50 microns and most preferably at least 100 microns. Typically the size is less than 2000 microns and preferably less than 1500 microns. The stream may take the form of an atomisation of droplets sprayed or misted, but preferably the stream is fine and fairly continuous/viscous, although even such a stream tends to break up into individual droplets after a certain distance of time. The above-mentioned set values are used to refer to spherical droplets and to a weighted average of the particle diameters for a plurality of small droplets. Continuous flow tends to break up into small droplets with a diameter approximately twice that of the flow. Suitable opening diameters for the container are therefore about half the diameter of the droplets given above or approximately between 10 and 1000 microns, preferably between 20 and 800 microns. The above concept applies quite independently of liquid viscosity and tendency to apply to both solutions and ointments.

Eye cup

The advantages provided by the present invention can be exploited without using one eyecup component of the device if the operator is responsible for the positioning or stabilization of the device. However, it is preferred to include an eyecup component to protect the operator from these duties. A suitable eyecup component includes at least one rim and a chamber.

The purpose of this edge is to provide contact between the device and the face and preferably also to self-center the device in a desired position relative to the eyes. The contact may rest against any part of the face such as the forehead, nose and cheeks but generally better centering is obtained if the rim is in contact with the eye socket. The term "edge" should be understood in a broad sense to mean that the contact point or points do not need to be shaped as an edge portion or other elongate part, but at least one and preferably two, three or more contact points should be provided, which are distributed in two dimensions for optimal centering. The dots may preferably be shaped as one or more continuous edges and most preferably as one continuous ring. For ease of explanation, it is assumed that a line can be drawn to connect the contact points into a "contact curve," which also represents theoretical face contact points that are not actual contact with the edge, and that the contact curve and edge line of the edge are considered to be coincident/coincident in the case of a closed continuous edge. A plane containing the contact line is drawn to form a theoretical "contact plane". A line drawn perpendicular to the plane forms a "contact axis" and a "contact direction" along the axis from the device toward the eye, or stated differently, from the chamber toward the edge. The contact axis and contact direction should be considered "symmetrical" if on the device side they are centered within the contact curve or if on the patient side they are directed radially towards the eyeball. Suitable edge forms are known in the art and are not critical to the present invention. It is preferable to use a left/right symmetrical edge shape so that it is equally usable for both eyes with a similar bayonet. For example, an edge having a substantially elliptical contact curve may be used that fits into the eye socket in size and shape. While such a generally elliptical contact plane is typically slightly curved along an axis parallel to the minor axis of the ellipse, it may also be flat. The rim may in a known manner preferably have an eyelid traction protrusion, preferably in the contact direction, for a specific contact with at least the lower but preferably also the upper eyelid for moving and holding the eyelid. Structurally, at least on any eyelid retracting portion, the rim may have a soft edge for comfort and is preferably a high friction material. The rim may be made integral with the chamber part, but preferably is a separate part mounted, bonded or welded to the chamber part for free material or colour contrast selection.

The chamber serves to provide space for the protruding eyeball within the boundaries of the contact curve and to ensure a safe distance of any element in front of the eyeball from the eyeball, in particular the aperture as will be further explained. Thus, the chamber should be construed broadly to mean any structure that meets these objectives. The chamber may be a true cup shape as used in known eye washes but without its function and preferably has a more open structure such as to allow access to the orifice for opening and closing, to avoid formulation build up and to facilitate cleaning, to allow visual monitoring of orifice positioning and delivery by an assistant operator, and to facilitate manufacturing and the like. The minimum requirement is that the chamber structure provides support and attachment to the rim, such as a single arm or rod extending away from the rim in a direction opposite to the contact direction, although two or more arms, such as a cage structure, may also be used. As will be further explained below, the eyecup should be positioned over the orifice of the container in a manner that allows liquid to be delivered to the eye, particularly within the contact curve of the rim. This relationship may depend on the transport principle used, with particular degrees of freedom in droplet transport, but it is generally preferred to position the orifice behind the contact curve when viewed in the direction opposite to the contact direction, and with a protrusion in the contact direction within the curve. The orifice may preferably be directed or arranged within the chamber, preferably with at least one fluid transport direction component parallel to the contact direction. A safe distance between the apex of the aperture and the plane of contact is preferably maintained to prevent contact with the eyeball for any foreseeable individual anatomy and to prevent fear of the patient from such contact, for example a distance of at least 5 mm, preferably at least 8 mm and most preferably at least 10 mm. The edge may be supported and connected to the container or its aperture by the chamber structure in the manner described above, but it is preferred that the edge is connected to the hand gripping portion, for example to allow unimpeded replacement of the container.

The eyecup may include additional features such as means to aid proper use and positioning such as some fixation points for the eye such as a mirror, lights, etc.

Mobility of eye cup

It is preferred that the eyecup is arranged to be movable relative to the housing when in use. The eye cup may preferably be movable between at least two positions, an active position providing the above-mentioned safety distance between the opening and the eye, and a position closer to the housing, for example to make the device more compact in its inactive state. The receptacle opening may be fixed relative to the eyecup, for example movable therewith, but in most cases it is preferred that the eyecup is movable relative to the opening and then fixedly disposed relative to the housing, although the option of moving the replacement receptacle or receptacles to and from the active position remains. The eye cup can be moved to more positions, for example further away from the housing or opening than in the active position, for example to increase the possibility of access to the eye cup or housing parts or the like. Preferably, the eyecup is completely detachable from the housing, for example for cleaning purposes. The mobility of the eye cup may be in any direction as long as the above requirements are met, for example, the contact direction of the eye cup may be such that it has at least one component of movement along the opening axis. The movement may be purely translational or may have a rotational component, the latter preferably being obtained by a hinge structure for the eyecup or an accessory thereof. At least some positions, preferably at least the active position and preferably also the rest position, are preferably defined exactly, for example by friction, snap-in, ball lock/shut-off valve (ball lock) or even a completely releasable lock.

A sensor or other device is preferably used to distinguish between locations and preferably send a signal to the device to activate it. The signal may distinguish all possible positions in a continuous manner, although it is generally preferred that the sensor emits discrete signals, for example at least one, preferably at least two and most preferably at least three positions. The signal may be of any type, preferably an electromagnetic or mechanical signal, as long as it can be converted into an action.

The signal received from the sensor may be in the form of an electromagnetic signal representative of the location or converted to an electromagnetic signal. The electromagnetic signal may be based on an electromagnetic radiation, such as an optical signal, but is preferably an electrical signal. A number of components suitable as sensors are designed for emitting such a signal output, but may be inserted in other ways in a circuit ensuring such an output. Any inherent, integral or independent structure may be considered a transducer for converting the sensor output into an electromagnetic signal. For example, one or more microswitches may be provided along the translational path of the eye cup or along a rotational path, such as a cam surface provided at a hinge axis.

Similarly, the signal received from the sensor may be in the form of a mechanical signal representative of the position or converted to a mechanical signal, such as a part attached to and moving with a movable eyecup in some manner. Any known actuator may be used as a transducer to convert a signal into a desired motion, with similar concepts as electromagnetic signals. Conversion of an electromagnetic signal into a mechanical signal or vice versa or mixing of the two signals in a signal link is not prevented.

The signal thus received or converted can be processed in a general sense, for example in a processor or a transmission, for delivering a control signal. The control signal itself is in turn used to control a function or operating element of the device. Although some typical examples will be given below, the operating element may be of any kind. Also, the control signal may have any property, e.g. mechanical, optical, etc., according to its further use.

The control signal may be used to send a message to the user, for example to warn or alert the user of an incorrect condition before the device is actuated for delivery. The message may be a sound, a tactilely perceptible signal such as a vibration, a visual signal in the form of a warning light or a more complex message on a display, etc. or a combination of any of the above.

Preferably the control signal is used to control a basic device function involving an action taken by an operator. The control signal may be used to enable or disable the device, respectively, depending on the correct eye cup status. The enabling/disabling may be performed by a mechanical connection or an electromagnetic connection, e.g. a relay device preventing mechanical function, e.g. a piston rod or pump mechanism. Preferably with some devices having at least some automatic means for driving the device, such as an electric motor, the operation of which can be determined by control signals. It is further preferred if the device further comprises processor means for controlling the motor means, e.g. in order to ensure correct container control, priming, sequence of actions, dosing, feedback of dosing data etc., in which case the electromagnetic signal may be sent to the processor to allow further flexibility, e.g. to allow the processor to issue a motor actuation control signal only when the eye cup status is met, or only when the priming step is correctly ended or the correct conditions have been positively verified in a self-control program. An existing processor unit may function here as a processor between the electromagnetic signal and the control signal.

The control signal may also be used to actually trigger the device, i.e. to initiate an automatic function once the sensor signal indicates a predetermined position condition. For the enable/disable condition just described, the trigger function may be used with a purely mechanical drive means, preferably with an electric motor means, and preferably with an automatic control processing means in the device, by means of an electromagnetic release mechanism.

Preferably, the device is designed to assume at least one of a priming and a squirting sequence. A preferred arrangement is such that the device is only activated when the eye cup is in the active position or state. The rest position or rest state may be used, for example, to disable/disable triggering to place the device in a low power state or to initiate a new cycle of activation steps. A third position may be used to indicate a state of the device other than a rest state or an active state, such as a reset state or a change of state of the container, and may include a step of accessing the container holder. Not only the eyecup position, this movement is also preferably critical and intended to be active. For example, the device may actively move the eyecup to the active position when the activation or control has been successfully concluded, or the device may be a passive receiver of motion input, for example using motion for the firing mechanism in the device.

It is obvious that the above general sensor principle can also be used in devices for other purposes than eye treatment. The operations actually enabled or triggered may have various attributes. In a multi-dosing device, which may comprise mechanical, but preferably electrical, control of the delivered dose, ejection is preferably at least influenced. In jet injectors sensors may be used for touch triggering. The auto-penetration step may also be effected in an auto-injector type device, preferably such that the auto-penetration and auto-injection sequence is controlled, and possibly with a final needle-pulling step. Known autoinjectors deliver the formulation simultaneously during the penetration phase or allow injection at full penetration, the present invention being compatible with both operations. In the case of multi-chamber cartridges with an overflow or bypass structure-as is also known-the injection procedure may comprise the sequential injection of different preparations, for example an anesthetic followed by an active ingredient or an active ingredient followed by a cleaning composition.

Device embodiment

Some concepts will be presented below with respect to an embodiment in which an apparatus is provided using a container of the type described above with reference to our co-pending application PCT/SE00/01514, and in particular the multi-container arrangement described in the common carousel-type disc arrangement.

A delivery or dosing device for such purposes generally comprises a housing having a seat for the container or container structure, a pusher bar movable with respect to the housing substantially along the axis of the container located in the seat, and an actuator device operable to drive the pusher bar.

The housing should contain a seat for the container or containers, the minimum requirement being to keep at least the container to be emptied fixed relative to the ram, preferably so that the container axis and the axis of movement of the ram are parallel, and most preferably coaxial relative to the ram member to hit the container rear wall. Preferably the seat should be able to accommodate a container having the features described herein. The seat preferably supports the container against forward forces from the pusher bar and preferably also against some rearward and lateral forces. The seat preferably allows the entire rear wall surface on the chamber to be exposed to the ejector pin and should also expose one or more openings at least on the front side of the container to not block liquid flow, although the rigidity of the container does not require any substantial/heavy support. Preferably, the seat is also designed to allow easy replacement of discrete containers or to allow sequential movement of individual containers of a multi-container arrangement to an active position of the seat, for example by means of a track in which the arrangement can move in one or two dimensions. In a preferred embodiment, the containers are distributed in circles, preferably on a disk-shaped structure, adapted to rotate the disk in a carousel-like manner about a central disk axis to align the containers with the active position. This counting procedure can be performed as a start step, for example before or after the firing of a spring for the ejection movement of the pusher bar. For single or, in particular, multiple container arrangements, it is desirable to provide guide means to ensure good alignment with the axis of the pusher bar to achieve the required high delivery accuracy, such as on the pack associated with each container for engagement with at least one corresponding detent on the housing, seat or, preferably, the pusher bar and arranged for interlocking at the correct alignment. The locking between them can preferably be associated with a signal, for example a tactile or audible signal in manual operation or a mechanically or electronically detectable signal in automatic operation, to assist the stopping in the correct position. Furthermore, it is preferred to include a counting structure designed to detect the number of used or retained containers and to warn or prevent the reuse of the used empty containers, which structure may likewise be manual or automatic, mechanical or electronic.

The pusher bar may include a pusher head and a piston structure for moving the pusher head along an axis of motion. Although the pusher head may be arranged to be non-conforming to the container cavity, for example for different cavity shapes or when relying on the stretch characteristics of the rear wall for emptying, it is preferably designed for completely filling (fill-out) the cavity. This may be achieved by a soft and adaptable pusher head, e.g. for the purpose of being compatible with different chamber forms, to increase the operating range or to obtain a certain emptying pattern, preferably to squeeze liquid out of the peripheral chamber portion towards the central, axial part, which may be achieved e.g. by making the soft pusher head slightly shallower in shape than the chamber reservoir form. However, for a single chamber form, it is preferred to have the pusher head front surface substantially the same as the interior chamber surface or in other words the rear surface of the front wall in the container space. The pusher head may be surrounded by a support structure, such as a tube structure in which the pusher head travels, which also preferably fits circumferentially around the chamber to seal the space between the pusher head and the chamber at least during collapsing movement of the rear wall, e.g., to allow high pressure or reduce the risk of leakage. The piston component of the ram is generally not critical to the dynamic characteristics of the injection, but rather to the thrust force, as will be explained in connection with the actuation system.

The pusher bar may be advanced by a variety of mechanisms and energy sources. The mechanism may be directly operated by manual energy, however, in this case, a lever action or gear exchange is preferably used to preferably boost or convert force or speed towards low and high speed. In order to obtain controlled and consistent results, it is generally preferred to have an automatic function, i.e. the propulsion is performed automatically, and preferably irreversibly, using stored energy after activation by the operator. This energy may be stored in any manner, such as in a mechanical spring, gas spring or gas generator, as electrical energy storage or a combination of the above. This energy may be transferred to the ram by a suitable electric motor or transmission structure, such as an electric motor or solenoid motor for electric energy, a piston and cylinder arrangement for a gas spring or gas generator, and a rotating shaft or plunger for a coiled and helical spring, respectively. It is generally preferred to include a transmission between the motor means and the pusher bar itself, wherein the force enhancement is provided, for example, by a gear or a transmission in the form of a cam surface. Preferably at least the pusher head and preferably the elements of the pusher piston are prevented from rotating during the forward movement, which can be ensured by any known guide structure, such as a non-rotationally symmetrical element cooperating with a complementary element, which are positioned on the pusher rod and on the housing, respectively. A preferred drive assembly for advancing the pusher ram is a lead screw nut arrangement, one of which is positioned on the pusher ram and the other on the motor side of the drive. The required speed, force and movement characteristics for the ejector pin depend on various conditions, such as the nature of the container part and the opening, the particular application embodiment, such as surface or penetrating delivery, the viscosity of the formulation, such as an aqueous solution or an ointment, etc., and no general description is given. However, the energy source, the motor arrangement and the transmission as exemplified can be adapted to various needs. It has been found advantageous to include a damper, such as a bumper, linear damper, flow valve, magnetic damper, etc., to control the speed with a constant force maintained. In most applications, it is desirable to have a rapid rise and fall pressure, often requiring the pusher bar to have a steady without slowing speed, which is facilitated, for example, by a damper or high inertia in the pusher bar and actuator.

Preferably means are also included in the device to facilitate breaking/breaking or removal of the temporary seal over the opening. Although the seal can be broken by the pressure itself generated when a rear wall is broken, it is preferred to use an effective step to break the seal. This can be achieved by having a sealing-off tool arranged in connection with the housing, for example a piercing tool for a breakable seal or a wedge or pull-out for removing a peelable sealing film. These structures may be provided at or near the seat, for example to allow later action, or at the distal end, for example when the seat area is crowded. The unsealing means may be operated manually or automatically or forcibly, for example as part of the action of the container into the seating position. However, it has been found to be advantageous to locate the de-sealing tool on the rear side of the container for movement from rear to front, which allows the de-sealing tool to impact the film in the best way possible, i.e. lift it off the front surface of the front wall on the rear side of the film. This also allows the unsealing tool and mechanism to be more conveniently located within the housing and behind the container to reduce interference with the ejection area and ejection target.

The tool can be arranged on or connected to the ejector beam in such a way that it moves together with the ejector beam using the same movement mechanism, facilitating a removal just between ejections and becoming an inevitable part of the ejection process. For the foregoing reasons, the tool may preferably have its own motion mechanism. Preferably the unsealing means passes through the opening in the front wall structure and possibly also through the rear wall in a position not occupied by the container chamber but covered by the sealing film. Preferably, such an opening and the de-sealing tool are mutually sized to serve as a guide arrangement as described above for final alignment of the pusher bar and the chamber prior to actuation. In operation, the tool first lifts the film from the container opening and then the pusher head hits the container back wall. These two steps may be performed in a single continuous movement for the ejector pin, for example for the simplest operation, and the latest possible unsealing, or in a two-step operation, two triggering actions by the operator may be required, for example in order to enable the operator to verify that the film has been correctly removed. It is also possible to use different movement characteristics for the two steps, for example a slow movement for exfoliation so as not to cause tearing or damage, and a fast action for ejection, which may require some switching means, such as a gear shift, a disconnecting means of the brake or a damper, etc. This general container design principle of the present invention strongly enhances the above-mentioned advantages, among others, by having a rigidity that allows the front wall to be used for guiding purposes and allowing the use of areas outside the chamber parts without instability problems.

An apparatus as exemplified may be adapted for different uses. Depending on each application, it may be advantageous to equip the apparatus with structures that assist in determining the target and location. For example, when used to direct fluid to the eye, the device may have an eyecup as described above. Penetrating applications may require a small distance or direct contact between the opening and the target surface and may require a structure for triggering the device at a certain contact pressure of the end piece towards the target location. Larger surface treatments may require a tip that defines both angle and distance.

Method

The foregoing description has been made with reference to structural and operational features either directly or indirectly, or in light of a description of structure, function, and objectives. The present invention is to be considered as incorporating and including aspects and features of the devices and methods. This methodology aspect is not repeated further. Method aspects will now be illustrated with reference to the accompanying drawings. Otherwise the ejector of the invention may be used conventionally or as described in the prior art.

Brief description of the drawings

Fig. 1A shows the device in an exploded view, while fig. 1B to 1G show in cross-section 5 operating stages of an embodiment of the device, driven by batteries and an electric motor, and using a tray with single-dose containers designed to be pressurized by a pusher bar. FIG. 1H shows the components of the main lever (main lever) in more detail.

Fig. 2A to 2C schematically show an alternative embodiment of an overall mechanical device designed to be fired by manual energy, in an open view and two cross-sectional views, respectively.

Detailed description of the preferred embodiments

Fig. 1A to 1H depict an apparatus in which an on-board motor is used to fire (cock) the pump drive of a pump mechanism while retracting a peel pin, while performing a final count of the disk containers, and then the peel pin performs an advancing motion to sense and finally remove a temporary seal in the form of a foil over the container opening.

Fig. 1A shows an exploded view of the device components. The device 100 may include a housing 110 having an upper body 111, a lower body 112, and an externally accessible trigger 113. The housing also includes a door 114 that can be opened to insert or replace a tray 116 having a plurality of receptacles 117 with openings 118 and stripping holes 119 when the eyecup is in a distal position. A movable eyecup 120 includes a rim 122 connected to an arm 124, the other end of the arm 124 being connected to a hinge pin 123 supported in bearings 128 and 128' having a cam member (not shown) that moves with the eyecup and acts upon an internally mounted sensor as described below. The housing also includes a window 124 over the display and a battery compartment 125.

The housing has an upper chassis member 126 and a lower chassis member 127 that supports the mechanism of the device. The mechanism may include a drive mechanism, generally designated 130, an actuator 140, a pump mechanism 150 having structure for storing the firing energy, a stripping mechanism 160, a counting mechanism 170, and a control system 180 including a plate 181 for electronic components.

The drive mechanism 130 includes a battery-loaded electric motor 131 having a rotatable shaft with a front encoder 132 for counting the number of revolutions of the motor and an external thread 133 for mating with an upstream gear in the drive train. The motor and the detector for the rotation of the motor are mounted on the circuit board 181.

The transmission 140 may include a set of gears in a gear train designed to reduce motor speed and increase force to accommodate various functions. A stripping wheel 142 is designed to drive the stripping mechanism, intermediate wheels 143 and 144 are components of the gear train without any other function, and a firing wheel 146 is designed to drive a firing mechanism for the pump mechanism. See fig. 1H for details.

The pump mechanism 150 includes a rod 152 that is rotatable about a rod axis 153 that allows it to move up and down the end of the eyecup end of the housing. At the other end of the rod is a damping member 154. The damping element is connected to a piston part of a damper 157, the cylinder part of the damper 157 being designed as fixed. In this configuration, the piston moves against the vacuum and air drawn into the cylinder for damping the velocity of the ram impact. The pump mechanism includes a pusher bar 158, the pusher bar 158 being rotatably connected to the bar at 159 and guided within the base frame such that the pusher bar can impact the deformable rear wall of the container in a substantially linear motion. Downward movement of the stem 152 away from the eyecup in the position shown is used to fire a spring 156 in the pump mechanism. The firing spring is designed to throw the pusher bar toward the container 117 when released to eject liquid through the opening 118. As best shown in FIG. 1H, the rod has a nut 151 with internal threads (not shown) for mating with threads of a threaded member that is externally threaded for rotation with the firing wheel 146 in the driver. The nut is connected to the rod so that the rod can move up and down according to the direction of the motor. The nut is coupled to the rod to retain (catch) the rod only in its firing direction and not in the release direction. A spring biased L-shaped pusher bar lock 155 is designed to move under the lever 152, when in the firing position, to hold the lever in that position until released. After the motor has been reversed, the nut can then be moved in the release direction free of the lever until it touches the lower leg of the L-shape, which will release the pusher bar lock and throw the pusher bar, and which will occur when the stripping pin 162 has reached near its forwardmost position and thus stripping is completed.

The stripping mechanism may include a stripping pin 162 keyed to the chassis at 164 to prevent rotation thereof and having internal threads 166 for mating with external threads on the stripping wheel 142 to allow up and down movement thereof by the motor. Obviously, in this embodiment, the motor and driver directly drive the stripping pin rather than via a firing spring or similar energy store. At the end of the forward peeling motion the pump mechanism is actuated to throw the ejector pins by releasing the ejector pin locks 155 in the manner described above. On the rear side of the peeling wheel 142 a force sensitive transmitter 168 is provided for switching at a certain reaction force to the resistance to be overcome by the peeling pin when the temporary sealing foil is torn off, which allows the control system to verify its presence.

The counting mechanism 170 includes a counting wheel 172 for engaging a correspondingly shaped container hub with teeth corresponding to the same number of containers on the disk. The counting wheel has a certain mobility and is spring-loaded to facilitate the connection with the disk. At the other end of the count wheel are a toothed inner gear 173 and an outer gear 174. An incremental structure is driven by the key 164 of the stripping pin 162, which, in the backward movement, acts on a ramp 176 of an axial rod 175, which in turn acts on a radial rod 177, which radial rod 177 is in hook contact with the inner catch wheel 173 to rotate the counter wheel by one tooth. A counter bar 178 is in contact with the outer gear wheel via a spring biased hook to prevent rotation of the counter wheel in the opposite direction. This count corresponds to one tooth after ejection in each operating cycle and aligns a new container with the pusher bar. This is an incremental action that begins when the rearward movement of the stripper pin reaches a distal position relative to the eyecup component of the device where the pin has been withdrawn from the stripping aperture of the disc so that it can rotate. This action is also detected by a count sensor (not shown) which the processor on the circuit board 181 also uses to decrement the number of remaining doses displayed on the display. The processor is also arranged to prevent triggering after all doses of the disc have been ejected or when a defective container has been detected, by moving the stripping pin to its rearmost position, triggering the opening of the door for disc replacement.

As described above, most of the electronic components are located on the circuit board 181. In addition to the above elements, the control system 180 includes: a display 182 also connected to the circuit board, and a door lock 183 with an arm 184 that acts on a door sensor 188 depending on the position of the door. In addition, sensors 185 and 186 cooperate with the above-described cam surfaces in support 128' to detect the position of the eyecup. A switch 189 is provided on the chassis lower member 126 which is acted upon by the trigger 113. A processor 187 is provided for operation of the apparatus.

Fig. 1B to 1F show various stages of operation of the apparatus. Fig. 1B corresponds to a ready state just before one ejection cycle. The peel pin 162 is located in an intermediate position immediately behind the foil to be removed. It should be noted that the firing spring 156 is already in a state of firing, which is performed earlier at the time of rearward movement of the stripping pin, and the damper 157 is in its initial position. In the touch foil position shown in fig. 1C, the trigger has been actuated and the motor has moved the peel pin forward a short distance to a point where it penetrates the peel hole 119 in the disk and touches the foil to verify the presence of the foil by sensor 168. In the peeling position of fig. 1D, the peeling pin 162 has completed its forward movement and the foil has been removed. In the injection position of FIG. 1E, in the most forward position of the stripper pin, the pusher bar lock 155 has been released, which triggers the pusher bar 158, which has completed ejection in the position shown. The rod 152 moves upward on the right in the figure under the action of the firing spring 156 and downward on the left in the figure under the action of the retraction of the piston of the damper 157. In the start counting position of fig. 1F, the device has been re-fired at the return movement of the stripping pin by again reversing the motor and the stripping pin further back than in the position of fig. 1B, where the counting of the discs is started at a further backward movement of the stripping pin in this position of fig. 1B. In the latter part of the backward movement of the stripping pin, the counting of the discs will end. The stripping pin can be moved forward to the ready position shown in fig. 1B by again reversing the motor. In this position, if the trigger 113 is depressed, and if the eyecup 120 is in the active position as shown, the device is ready for a new ejection cycle. Alternatively, as in the uncapped position of FIG. 1G, the processor may move the stripping pin to a position further back than the start count position shown in FIG. 1F, which will release the mechanical lock for the door 114 to allow the disk to be replaced, which also requires the eyecup to be swung 180 degrees from the position shown to a remote position. This will occur when all the containers of the disc have been used or if a failure is detected.

The use of the device will now be described from a starting position in which the device is in the ready position shown in figure 1B. If the eye cup is in a rest position (not shown) it needs to be moved to the active position shown to actuate the device. The display may display a warning signal, for example by flashing. The eyecup is placed on the eye and the trigger is actuated, which may only occur when the eyecup is in the active position, and this will initiate a full stripping, squirt and count sequence in a forced manner through the above actions until the device is once again in the state of fig. 1B. Alternatively, actuation of the trigger will only cause the device to proceed to full peeling of the foil as shown in FIG. 1D. A new trigger action will then be required to complete the full ejection as shown in fig. 1E and automatically proceed to the full finish state as shown in fig. 1B or the uncapping position as shown in fig. 1G. The second trigger should be made within a certain time frame from the first trigger, otherwise the processor will automatically go to the end and the dose is lost. This is to avoid the risk of contamination of the container after uncapping. When all the doses have been consumed, the handler will activate the motor to drive the stripping pins to their rearmost position as shown in figure 1G in order to replace the disc. Upon detection of a new disc, the processor moves the stripping pin to a ready position as shown in FIG. 1B and resets the dose counter.

Fig. 2A-2C depict a schematic view of an improved arrangement relative to fig. 1, and the differences will be mainly explained below. The device of fig. 2 is a fully mechanized device and is designed to be operated by manual energy due to the device being manually depressed from a distal position relative to the housing toward an approximated position by the eyecup and storing the energy in the spring of the device as firing energy. In fig. 2 the device is shown in an active state before ejection, i.e. when manual energy has been input and the eyecup is ready for ejection in its active position.

The device 200 may include a housing 210 having an externally accessible trigger 212 coupled to a start pin 214 and a detent 213. The housing also includes a door 214 that can be opened for insertion or replacement of trays 216 having receptacles 217 when the eyecup is in a distal position, the receptacles 217 having openings 218 and stripping holes 219. An eyecup 220 includes a rim 222 connected to an arm 224, the other end of the arm 224 being connected to a hinge having an axis of rotation through the housing and to the mechanism of the device. The mechanism may include a drive mechanism, generally designated 230, a firing mechanism 240, a pump mechanism 250, a stripping mechanism 260, a counting mechanism 270, and a control system 280.

The eye cup arm is connected to a partial wheel 232 of the drive mechanism, which actively transmits the rotation to a drive wheel 236 via a "pendulum movement" connection 234. The drive wheel is connected to a firing wheel 242 of the firing mechanism 240 by a free wheel system 238 that is designed to allow simultaneous rotation of the wheels when the eyecup is depressed toward the housing, but to disengage the firing wheel from the drive wheel when rotated in the opposite direction. The drive wheel has an extension with a slot 239 for cooperating with the detent 213 of the trigger so that the trigger and hence the eyecup can be pushed when the drive wheel is aligned with the slot, which occurs when the eyecup is in the active position, rather than when the detent is in the extension outside the slot.

The firing wheel 242 of the firing mechanism is coupled to a rod 244 that can rotate about a rod hinge (not shown) shown at the end of the embodiment of FIG. 1, allowing its eyecup end to move up and down. The other end 246 of the rod is connected to a damper as in fig. 1. Downward movement of the rod 244 away from the eyecup in the position shown is used to fire separate springs in the pump mechanism and stripping mechanism.

A pump mechanism 250, which is substantially symmetrical about the centerline of the device, includes a plunger 252 and pump spring 254, which is designed to throw the plunger toward the container 217 upon release to expel liquid through the opening 219.

Similarly, the stripping mechanism 260, which is substantially symmetrical about the device centerline, also includes a stripping pin 262 and stripping spring 264, which mechanism is designed to throw the pin toward the disk 216 upon release so that the pin passes through the stripping aperture 219 of the disk to remove the temporary sealing membrane. This release occurs when one of the actuator hooks 266 is released/freed (free) by the action of the trigger 212 by the start pin 214 and one of the intermediate actuator rockers 268. The firing wheel will be rotatable in the opposite direction to the firing motion when the release occurs. At the end of the peeling motion the pump mechanism is actuated to throw the ejector lever.

The counting mechanism 270 includes a counting wheel 272 for engaging a correspondingly shaped container tray hub, here shown having 14 teeth corresponding to the number of containers on the tray. The count wheel is coupled to an incrementing device 274 that is designed to rotate the count wheel and disk by an angle corresponding to one tooth. This incremental action is initiated when the stripping pin reaches a distal most position relative to the eyecup component of the device when the device is fired, where the pin has been withdrawn from the stripping aperture of the disk so that it can rotate. The incremental action may also be transmitted to a counter disk 276 which is also incrementally acted upon to display a new remaining dose data in a housing window, the incremental action also being transmitted to a gear 278 which makes an incremental rotation. The gear has a bolt 279 which, after ejection of a 14 dose, comes into contact with the actuator rocker 268 to release the actuator hook from the drive wheel, thereby moving the eyecup to a distal position beyond the active position, which in turn allows opening the door for disc replacement.

Use of the device will now be described from a starting position when the device is fired with the eye cup in a near rest position, where the trigger cannot be depressed because the detent 213 is located outside the slot 239. The eyecup is moved to an active position where the trigger can be depressed. The eyecup is pressed against the eye and the trigger is actuated, which initiates a complete stripping, squirt and count sequence in a forced manner through the above actions. Upon release of the trigger, the drive wheel 236 and thus the eyecup are released and the spring associated with the drive wheel will automatically move the eyecup to a distal position at about 30 degrees from the exterior of the housing to cause a firing motion to be performed on the eyecup by the user. The user pushes the eyecup to this near rest position which fires the device and also counts and increments a counter on the tray at the end of the sequence. The eyecup is locked in the resting position until it is actively moved to the active position for a repeated cycle. If 14 doses have been used, the eyecup is not locked but can be moved to a remote position where a door can be opened to replace the tray.

The invention is not limited to the embodiments described and shown but may be varied within the scope of the patent claims.

Claims (19)

1. A device for emitting a fluid stream moving from a proximal position toward a distal position, the device comprising: a) a housing, b) a container for said liquid, c) at least one opening arranged for emitting a liquid flow and in liquid communication with said container, d) a pump mechanism operable to deliver at least part of the liquid from the container through said opening to form a liquid flow, comprising a pump driver operable to store cocking energy for driving said pump mechanism, and e) at least one actuating mechanism operable independently of said pump mechanism to activate said device for liquid delivery, characterized in that said improvement comprises a drive mechanism designed to convert manual or stored energy into I) cocking energy of the pump driver and II) direct or stored energy for operating the actuating mechanism.

2. The device of claim 1, wherein the firing energy is at least partially stored in one or more mechanical springs.

3. The device of claim 1, wherein the drive mechanism is designed to receive manual energy.

4. The device of claim 1, wherein the drive mechanism is designed to receive stored energy.

5. The device of claim 1, wherein the stored energy comprises electrical energy, preferably stored in a battery.

6. The device of claim 1, wherein the drive mechanism comprises a transmission.

7. The device according to claim 6, characterized in that the transmission is designed to perform a deceleration to convert from a lower force to a higher force.

8. The device of claim 1, wherein the actuating mechanism is configured to drive a counting action that brings a container into operable relationship with the pump mechanism.

9. The device of claim 1, wherein the actuating mechanism is configured to drive a peeling action that removes a temporary seal from the container.

10. The apparatus of claim 9, wherein the peeling action comprises moving a resealing tool through a tray having a plurality of receptacles.

11. The device of claim 10, wherein the peeling action includes a controlled detection of the presence of the temporary seal prior to its removal.

12. The device of claim 1, wherein the drive mechanism is designed to fire stored energy for driving the actuation mechanism.

13. The device of claim 1, wherein the drive mechanism is designed to fire stored energy directly for driving the starting mechanism.

14. The device of claim 1, wherein the drive mechanism is designed to drive the firing and actuation mechanism at least partially in sequence.

15. The device of claim 14, wherein at least two of the motions are driven by the actuation mechanism and at least two of the motions are driven at least partially sequentially.

16. Device according to claim 1, characterized in that the actuating mechanism is designed to drive a control step and/or an activation step for the container or opening.

17. The device of claim 1, wherein the device comprises an eyecup having a contact surface configured to contact the eye or its facial periphery.

18. A method for operating an ejection device to eject a fluid stream moving from a proximal position toward a distal position, the device comprising: a) a housing, b) a container for said liquid, c) at least one opening arranged for emitting a flow of liquid and in liquid communication with said container, d) a pump mechanism comprising a pump driver capable of storing cocking energy for driving said pump mechanism, which pump mechanism is operable to deliver at least part of the liquid from the container through said opening to form a flow of liquid, and e) at least one actuating mechanism operable independently of the pump mechanism to activate said device for liquid delivery, characterized in that it comprises the step of operating a drive mechanism to convert manual or stored energy into I) cocking energy of the pump driver and II) direct or stored energy for operation of the actuating mechanism.

19. The method of claim 18, characterized by the steps of any of the other claims.