JP2004528069A - Method of operating liquid delivery device and injection device - Google Patents

Abstract

Apparatus and method of use for injecting a liquid stream toward an eye, the stream moving from a proximal position to a distal position, the apparatus comprising: a) a housing; b) a container for a liquid; A) an opening arranged to emit a stream and in fluid communication with the container; d) a pump mechanism for pumping at least a portion of the liquid from the container through the opening to form a stream; e) an eye or around the face thereof. An eyewash cup with a contact surface arranged to contact the eyewash cup. The eyewash cup is arranged to move and identify between at least two positions: i) an active position where the contact surface is at a safe distance, and ii) a rest position where the contact surface is at a more proximal position. The sensors are arranged as possible. The pump mechanism is operable to start the device for liquid delivery, and the drive mechanism converts the energy to i) hoisting energy of the pump driver and ii) energy for operating the actuation mechanism. It is arranged to be.

Description

【Technical field】
[0001]
The present invention relates to an apparatus and a method for injecting a liquid stream, particularly towards the eye, wherein the stream moves from a proximal position to a distal position, the apparatus comprising: a) a housing; A container, c) at least one opening arranged to inject the stream and in fluid communication with the container, and d) operable to deliver at least a portion of the liquid from the container through the opening to form a stream. A pump mechanism and e) an eyewash cup with a contact surface arranged to contact the eye or its face. The pump mechanism may include a pump driver capable of storing hoisting energy for driving the pump mechanism, wherein at least one actuation mechanism is present and operable to start the device for liquid delivery. There may be.
[Background Art]
[0002]
An apparatus for injecting a liquid stream may have many utilities. In the medical field, typical applications include treatment of body surfaces such as infusion or infusion, treatment of body cavities, pulmonary delivery or local treatment. For reasons to be explained, embodiments of the present invention have particular utility in ophthalmology and especially in liquid treatment of the eye. Although the invention is described in this application for convenience and unless otherwise indicated, aspects of the invention have broader utility.
[0003]
Devices for delivering fluids, especially liquids, to the eye have long been used for a very wide variety of purposes. A typical eyewash cup for comfort, refreshing or rinsing may comprise a cup of an anatomically adapted design for immersing the eye. The delivery of large volumes of liquid, usually by a spray device, is also used for cleaning the eyes, for example in an emergency. The present invention is primarily a device suitable for administering relatively small volumes of fluid to the eye, and is sufficiently convenient to handle, even in self-administration situations, to facilitate or facilitate frequent use. Related to the device. A common use is to administer drugs to the eye. Typically, a pharmaceutical preparation must be delivered in a very well-defined volume to ensure a particular dosage to be delivered or absorbed. Due to inappropriate physiological effects, which are absorbed by non-target tissues or the excess is expelled through the lacrimal gland into the pharynx, or because of the inconvenience of overflowing the face and clothing, No surplus is allowed. Price considerations also apply to expensive drugs. By way of example, treatment of glaucoma often requires daily administration of, for example, prostaglandins, beta blockers or other expensive active ingredients, which may be desirable when all are absorbed by other body tissues other than the eye. Has a function other than the blood pressure-relieving action. In addition, the proper administration of small amounts is cumbersome due to the fact that the active ingredient cannot enter the eye without passing through the restricted area of the cornea. Although the devices to be described herein can be used with any fluid for any purpose, for convenience the present invention will be described in terms of medical applications.
[0004]
The above situation places severe demands on the indicated multipurpose device. Inevitably small quantities of the preparation must be positioned with great care in the eye so as not to cause the stated dosage, overflow, side effects and target errors. Typically, start-up steps and secondary steps, such as control of equipment and preparation conditions, must be mastered.
[0005]
These requirements shall be met when using the simplest delivery device under the control of a skilled operator who may initiate medically relevant corrective actions in case of accidents and malfunctions. Can be. Also, for example, when using high performance machines in a hospital environment. However, the general treatment trend places the responsibility for administration on the patient himself, as is the case with children, the elderly and the disabled. In the case of long-term treatment, the patient is often somewhat skilled, but there are also few dosage schemes, often involving emergency situations or patient inequality. Other inherent problems in patient self-administration, compared to assistant-manipulated administration, require less well-positioned and often nervous positions, and the perceived or experienced pain or discomfort may be May interfere with the desired working pattern. In summary, self-administration, in particular, requires more sophisticated devices to facilitate the injection procedure and to avoid or reduce the risk of mistakes. Patients that rely on daily or occasional dosing have a reasonable need for convenience and have sufficiently unrelated devices to bring them into everyday life. It is desirable that the high performance and convenience of such a machine be kept simple and inexpensive and be capable of being packaged in a wide range of distribution and disposable devices.
[0006]
Prior art devices can only fulfill the described requirements to a limited extent. Devices with a manually controlled pump mechanism have been proposed, for example, in WO 98/55059 and US Pat. No. 5,607,410, for convenient use and for small transport configurations, respectively. Has features. However, such a device does not have any specific means for self-control with respect to a multi-dose container, for example with respect to the starting step or liquid state. For some purposes, it is desirable to replace a manually operated pump mechanism with some form of automatic operation. The automatic operation typically involves the release of stored energy, for example, for a controlled start, trigger, force, speed, standstill or sequencing. Special requirements may also be imposed by the requirements for high liquid velocities. Medical devices of this type are, for example, auto-injectors in which liquid injection occurs automatically after a trigger, and jet injectors in which penetration occurs by using liquid velocity instead of using a needle. In eye treatment, by ejecting a controlled amount of liquid from a pressurized chamber through a narrow orifice, the liquid is delivered fast enough to precede the blink reflex and very small doses, That is, rather rapid liquid streams have been proposed for the purpose of allowing smaller volumes to be delivered than gravity delivered drops. Devices of this type are described, for example, in WO 96/00050 for multi-dose containers and WO 96/06581 for single dose containers and in our co-pending International Patent Application No. PCT / SE00 / 01514. The disclosed proposals of this kind are not optimal for use in portable or hand-held devices, both in terms of convenience and suitability for further automation.
[0007]
Thus, the various handling steps involved can assist the user, prevent or improve mistakes, and provide an ergonomic, convenient and non-traumatic product that is particularly useful for patients performing self-administration. There is a continuing need for inexpensive injection devices. The present invention has a more general utility, but will be described primarily against this background.
DISCLOSURE OF THE INVENTION
[Problems to be solved by the invention]
[0008]
It is a primary object of the present invention to provide a liquid delivery device which meets the above general needs and which is better than previously known devices. A more specific purpose is to provide such a device suitable for portable or handheld use. Another object is to provide a device that is convenient to use and suitable for self-treatment situations. Yet another object is to provide a device useful for mechanized rather than manual operation of the liquid pump mechanism. Yet another object is to provide a device having an arrangement for starting and / or controlling steps. A further object is to provide such a device suitable for automating or motorizing functions. Yet another object is to provide a motorized device that provides energy and / or power savings. Yet another object is to provide a device suitable for high speed delivery of liquid. Another object is to provide a device that is compatible with multi-dose or single-dose containers. A further object is to provide a device suitable for use in one or several replaceable single-dose or multi-dose containers. Yet another object is to provide a device with appropriate secondary properties outside of direct treatment situations such as refilling, initiation, control, cleaning, handling and manufacturing. Yet another object is to provide such a device suitable for delivering liquid to the eye. A further object is to provide an eye treatment device which is particularly suitable for conveniently and precisely delivering small volumes of liquid. A further object is to provide a method for the operation of such a device and / or a corresponding delivery method for such a device.
[Means for Solving the Problems]
[0009]
These objects are achieved with the characteristic features set out in the appended claims.
[0010]
According to one aspect of the invention, the device comprises an eyewash cup arranged to deliver a liquid to the eye and arranged to define a given relationship between the opening and the eye. By allowing the eyewash cup to move between at least two positions: an active position that provides a safe distance between the opening and the eye, and a position closer to the opening, for example, the device can Allows the device to be more compact when not active, improves portability, also increases the space between the device and the face during operation, improves handheld characteristics, and facilitates self-treatment To Deformation of the aperture facilitates its precise orientation, which is important to the precision of delivery, and its integration with the housing and pumping mechanism, e.g., requiring long conduits in between. Prevent it and make it more adaptable to high pressure delivery. If sensors or other arrays are used to distinguish between locations, the function of the device can be adapted as such, e.g., generate signals, operate electronic components or machines, and engage the device. It can be adapted to stop. It is possible to add further positions for the eyewash cup without sacrificing other points, for example for resetting, refilling, etc. Within the completely removable arrangement, the movable arrangement is also easily extended, for example, to facilitate cleaning or to allow the exchange or selection between different eyewash cup shapes or sizes. Mobility is adaptable to the added functionality, and such movement itself is important, not just the position of the eyewash cup. For example, when initiation or control is successfully completed, the device may act to move the eyewash cup to the active position, or the device may use motion for, for example, an arming or winding mechanism of the device. Thereby, it may be a passive receiver of motion input. It is clear that the functions outlined may serve to facilitate the automation and powering capabilities of the device. Similar advantages can be obtained in applications other than ophthalmic treatment if the application-specific moving parts are made to move in a corresponding manner.
[0011]
In accordance with another aspect of the invention, an apparatus includes an actuation mechanism operable to initiate a container or opening for liquid delivery, and manually and stored energy to and from the pumping-up energy of a pump driver of a pump. A driver arranged to convert the energy into energy for operating the mechanism. Using the hoist arrangement for the pump driver can be relieved from the user operating the pump and can be used to improve the timing, profile and target accuracy of the injection, and any pump power Means that a vessel pressure or liquid velocity can be generated. The use of the same drive mechanism for starting also facilitates handling of manual devices and reduces the complexity of automatic devices. The starting steps are common for delivery devices, for example, moving a new single dose container to the injection site, opening a sealed opening, mixing the preparation precursor, Or breaching the safety part, dose setting, degassing the container contents, arming or releasing the safety arrangement, and the like. The invention is adaptable to any starting step or combination of such steps. The available repertoire of initiation effects also makes the device adaptable to single or multidose containers, single or multiple container arrangements, or such fixed or replaceable containers. If the two deformations are separated in time or order, the peak force or energy requirements can be reduced. The same applies if two or more start steps are similarly separated. The arrangement is compatible with both a drive mechanism that directly operates the actuation mechanism or a drive mechanism that hoists the energy stored for the actuation mechanism. The outlined principles improve the convenience of use by reducing the required handling steps. By allowing control steps to be included and controlled, and by sequencing between the steps, the outlined principles also increase safety. The mechanization and automation of the device is facilitated by a combination of operating actions and possibilities, reducing force and energy requirements. For the same reason, the device mechanism can be simpler and less bulky, improving its portability and hand-operated properties.
[0012]
Further more specific objects and advantages will be apparent from the detailed description below.
[0013]
(Definition)
Unless specific details are expressly referred to, a “system” as used herein is described or claimed as one or more devices / arrays, methods, uses or combinations thereof. It is to be understood that, whether illustrated or implemented, it generally applies to the principles of the present invention.
[0014]
In the absence of an explicit description or obvious state of the contrary, expressions such as "comprising,""including,""having,""having," and similar language, as used in the present application, refer to the recited device element. , Compositions, compounds / components or method steps, it is to be understood that the presence of additional elements, compounds / components and steps is also possible. Any device element is understood to be described in integral, subdivided or aggregated form and is "connected,""attached,""arranged,""added." Expressions and similar phrases such as ",""between," and the like are not to be understood as describing exclusive direct contact between the recited elements, but the presence of one or more intervening elements or structures. Is understood to be possible. The same applies to similar expressions when used in describing force and action. Similarly, in the absence of an obvious statement or apparent state of opposition, such expressions include compositions, compounds / components in any physical or chemical aggregate or mixture, and It is to be understood that the order of the compounds / components or assemblies and the method steps can be intervened.
[0015]
Also, as used herein, positional and directional descriptions for both the container and the delivery device, for example, "axial", "distal" and "proximal", "front" and "rear", And "forward" and "rearward" etc. shall be understood with reference to the liquid delivery direction, as opposed to being drawn along a line centered on the container opening and the main or average delivery direction The line shall be considered as the system "axis", along which the liquid is delivered in the forward direction.
[0016]
Also, as used herein, the concept of "manual" in connection with the force or energy applied to the control of a device is such that the operator can directly or indirectly apply force or energy in a manner that takes account of controlling the procedure. It shall be understood to mean adding. As long as the action of the operator determines the progress, the operation of the procedure can be completely or partially driven using a force or energy from another source other than the operator, for example energy or gas stored in the spring or supplied energy. It should be understood that servo assist is included, but servo assist is often not necessary or preferred. In contrast to a "trigger" action, which may be an on / off action, a manual action carries, at least partially or to a limited extent, a functional relationship to a position in the affected procedure.
BEST MODE FOR CARRYING OUT THE INVENTION
[0017]
(Detailed description)
(General)
The devices described herein may be used for a variety of purposes, both inside and outside the medical field, and in any container for any type of preparation, e.g., chemicals, compositions or mixtures, It may be sent for purpose. For the reasons outlined, the system has certain special values associated with drug delivery devices where design constraints are more stringent than most other applications. For convenience, the present invention will be described in terms of this application.
[0018]
Typically, the material to be delivered is a fluid, preferably a liquid, including materials that behave as liquids, such as emulsions or suspensions. Although these observations relate to final preparation, other components, especially solids, may be present prior to final preparation. The nature of the container contents includes the drug in a broad sense, including, for example, natural ingredients and bodily fluids that are pre-filled or placed in the container, but most commonly the drug may be factory prepared. Shall be understood.
[0019]
The principles of the present invention can be used in a broad sense for a delivery device or system. The delivery conduit from the device may be an infusion channel or any guiding arrangement such as a tube or catheter, a needle or cannula or a needleless system based on liquid jet or a drop gun or a spray with or without gas firing. It may be. The material of the container contents can be delivered by using a delivery mechanism, also referred to herein as a pump or a pump mechanism, and any material that meets this requirement can be used. Typically, the material is a fluid, preferably a liquid, including materials that behave as liquids, such as emulsions or suspensions. Although these observations relate to final preparation, other components, especially solids, may be present prior to final preparation.
[0020]
The invention can be applied to a delivery device in a stationary or permanent configuration. For the reasons described, the present invention offers special advantages to delivery devices for mobile purposes, especially those that are self-contained with on-board energy storage, motor and processor arrangements, and especially truly portable This is the case with small handheld devices of the nature.
[0021]
(housing)
The device housing shall be understood in a general sense and, unless otherwise indicated, mainly represents a reference point for the movement and also a reference for the force applied by actuating the arrangement performing the movement. Points are also represented, so that a force is applied between the housing and the moving part or gripped part. The moving part may be present in the pump arrangement, i.e., for example, in a part that performs mixing, automatic penetration, needle injection and retraction, etc. The minimum functional requirement is that the housing provide a support or platform for moving parts and actuation arrangements that provide movement and force. In this situation, such moving parts may be present in the pump mechanism, its driver and hoist arrangement, and the starting arrangement and its actuation mechanism. However, as is common practice, containers that at least partially contain components, to the extent that only features designed to be controlled or monitored by an operator are preferably exposed externally Is preferably formed by the housing. In this current situation, such exposed parts include a hand-operated button to perform or trigger the injection, a door to the container seat to facilitate replacement, and a message for the user. And the like.
[0022]
(container)
The container portion is to be understood in a broad sense and may take various forms such as any type of tube, hollow container, flexible bag, vial, ampule, cartridge, carpool, syringe body, etc. . Common container materials such as glass or plastic can be used preferentially. The container may be an outer casing or a unitary or composite structure including any other multi-part structure for closure, securing, protection, etc., whenever used herein, “Container” shall be understood to include any spare parts present. The container may be refillable, e.g., for use in a disposable device, or of a pump system in which the container repeatedly draws a preparation to be injected from an external source or channel before each injection stroke. When it is a part, it may be integral with the housing. The container may be separate, e.g., to allow replacement in the case of disposable pre-filled containers, to easily sterilize or to discard when the type of contents or patient changes. Good. As is known per se, for example, if it is desired to perform the mixing before injection, or if mixing during injection when drawing a portion of the volume from each container, or different If the components are to be injected sequentially, more than one container may be present.
[0023]
The container has at least one opening, also referred to as an orifice, through which, during the main delivery operation of the device, for example from the interior of the container to the administration of a medicament to the patient to the surroundings, or the absorption of bodily fluids. In some cases, the medicament is advanced into the container, or during a preparation step such as filling, mixing or dissolving in the container, the medicament is advanced and an opening must be present throughout the operation. Certain device operations, such as initiation, can occur before communication is established, and is often even preferred, for example, in the case of an ampoule or bag, the container itself, a removable closure or pierceable Or that the opening requirements are deemed to be satisfied by a preparatory arrangement to form the communication, such as the presence of a rupturable part or a specially designed part in the case of a pierceable membrane or diaphragm. And All communication takes place through one opening, for example, the passage of the drug and the equalization of the pressure in or out of the rigid container. The container has a flexible or movable or deformable part, but nothing prevents further openings from being provided for a similar purpose, which is identical to at least one opening. Although possible, it may be quite different and may be adapted for another purpose, such as an infusion or syringe type with a movable wall or piston.
[0024]
The container is a simple bottle, vial or bag if the delivery device is arranged to draw a metered amount for delivery, either continuously or intermittently, as specified. You may. Often and especially in connection with self-administration, the type of container is more complex, generally in the form of a cartridge, the syringe-type container part of the delivery system, which is even more so in the case of a multi-chamber cartridge. It may be complicated. Cartridge-type containers will be further described as they generally require an additional starting or control step, for which the principles of the present invention can be preferentially utilized.
[0025]
A cartridge for this purpose generally comprises a front part and a rear part which define an overall cartridge axis, an outlet for preparations arranged in the front part, and at least one movable arrangement arranged in the rear part. It can be said to include a hollow container having a wall, and the displacement of the wall causes the preparation to move towards or through the outlet. The shape and movable walls of the hollow container must be adapted to each other. Hollow containers are most freely designed when the walls are flexible or oversized membranes or diaphragms and can be adapted to the inner surface of the hollow container by moving or reshaping. In that case, a fluid cushion or elastic material is required between the wall and the piston to relieve the applied pressure. Preferably, however, the hollow container has a substantially constant inner cross-section between the front and rear portions, also comprising a hollow container shaft, to provide a substantially tubular hollow container. Most preferably, the cross section is generally circular in shape, providing a substantially cylindrical hollow container. The movable wall is then preferably substantially permanent in shape, but may be elastic, and the body is sealingly adapted to the inner hollow container surface, and is preferably plunger-type, It has sufficient length to be self-stabilizing to tumbling while traveling along the hollow container. The front part outlet may be of any known design, and in certain applications is oriented laterally for best access, is non-coaxial to the front but to the hollow vessel axis, or , Most commonly the front and coaxially arranged. The outlet may be integral with the hollow container, or the cartridge leading edge may be provided with accessories in a conventional manner, provided with a breakable or pierceable seal before connection. Is also good.
[0026]
In general, the described cartridge requires several types of initiating action, depending on the displacement of the movable wall, and resets the device to allow for repeatable and reproducible dosing, meeting high precision requirements . In its first motion, the movable wall requires special de-power after storage to overcome both internal reshaping resistance and increased wall friction due to adhesion or depletion of lubricant at the point of contact. There may be. Also, for weaker regular injections, elastic or inelastic deformations and tolerances must be equalized in the movable walls, cartridge shells, outlet fittings, etc. The preparation itself may have a compressible inclusion such as a gas bubble. Degassing and pre-ejection are required to remove gas in the hollow container compartment and to fill the space inside the front sealing, outlet fittings and outlet device or needle, for example.
[0027]
Dual or multiple chamber cartridge types are known, for example, in preparations that require the mixing of two or more components or precursors prior to administration. The components are kept separated by one or more intermediate walls of different known designs, which divide the hollow container into several chambers, which may be arranged in parallel along the cartridge axis But are most commonly arranged in a stacked relationship along the axis. Component integration may occur by breaking, piercing or opening the valve structure of the intermediate wall, e.g., by passing a pin or needle through the front of the cartridge or through the rear movable wall or By introduction at the rear movable wall or by means outside the cartridge (compare for example WO 93/02720). In another known design, the intermediate wall or walls are plunger-type, and flow communication between the chambers is achieved by moving the plunger to a bypass section, where the inner wall has one or more enlarged sections. Or having a repeated circumferential groove in such a way that the displacement of the rear movable wall allows the contents of the rear chamber to flow into the front chamber (see, for example, US Pat. No. 4,968,299). Or compare with WO 93/20868 and WO 95/11051). The chamber may contain a gas, liquid or solid. Generally, at least one liquid is present. Most commonly in pharmaceutical applications, there are only two chambers, typically containing one liquid and one solid, the latter being dissolved and reconstituted during the mixing operation.
[0028]
The start of a multi-chamber cartridge requires all of the general mold steps described, but is in a degraded form due to the extra walls and spaces that are present. In order to provide efficient mixing, generally the mixing space must be allocated in addition to the space occupied by component volumes. Powder-like components in bulk form also require special spaces contained in the gaps between the particles. The mixing step may create a foam or gas fill that requires space to settle. The plunger-type intermediate wall generally has to be displaced, at least by its own length, in order to reach the unsealed part of the bypass. Overall, the multi-chamber cartridge requires a long moving wall stroke for both mixing and subsequent degassing at the start-up step and benefits in a special way from the advantages of the present invention.
[0029]
In general, the illustrated containers can be used for either single or multiple doses to be injected. In medical applications, multi-dose arrays often pose the risk of contamination of the container contents or loss of sterilization after opening and single use, which requires storage of the preparation. become. These problems can be avoided with single dose containers that are opened and then discarded in connection with the injection operation. For reasons of cost, simple and inexpensive single-dose containers have been proposed, having an opening and at least one wall which is flexible or deformable, so that the deformable part is squeezed out. By applying an impact, the contents of the container can be pressurized. Although various pressure directions can be used, such as perpendicular to the opening axis, it is often preferred to use a direction parallel to the opening axis in the forward direction, preferably coaxial. Such containers have been proposed for various delivery purposes, for example for needle injection as exemplified by French Patent No. 1,538,565, US Pat. No. 2,642,062. , For through-jet injection as exemplified by U.S. Pat. Nos. 3,419,007 and 5,026,343, and WO96 / 06581 and the opening paragraph. For the treatment of the eye as exemplified by co-pending International Patent Application No. PCT / SE00 / 01514. Containers of this type can be used for the purposes of the present application, the most preferred designs being those described in the co-pending application. Such containers have a front wall having or surrounding a cavity corresponding to the form of an open hollow container, an opening in the front wall adapted to eject liquid from the container, and optionally a temporary use. And a rear wall that closes and seals the opening in the front wall of the hollow container to limit the space for liquid in the container. The wall runs at least partially perpendicular to the container axis and is displaceable or deformable to move toward the opening to pressurize the container liquid. The front wall is substantially rigid with respect to the rear wall, the rear wall is substantially flat or substantially unitary curved prior to pressurizing the container, and the rear wall is substantially It can be deformed in a state where it is stretched to fill the container cavity. The pumping mechanism of such a container may include a ram that presses or impacts a flexible or deformable wall, as described further below.
[0030]
Although the above considerations apply to a single, separately used individual container, it is preferred to provide a multiple container unit or package. This can be done, for example, by connecting several individual containers to a plurality of structures, by means of flexible joints, allowing the structure to be able to bend, fold or roll. Preferably, however, the multi-container package is a substantially rigid self-supporting structure, which provides advantages, inter alia, in connection with the delivery device. The construction can be obtained by joining the individual containers by rigid joints, but a preferred way is to use the rigidity of the front wall as described above by providing an enlarged front wall structure. The provision of several cavities in the structure, inter alia, to facilitate the production of a plurality of containers and to allow a smooth and uncomplicated exterior. By using features that flatten or single-curve the front and / or rear surfaces of the front wall structure, the attachment of the film on these surfaces is further simplified, in particular: If the container surfaces are coplanar, the undivided sheet material can be applied to several, preferably all, individual containers of the structure, for example, the rear surface of the structure with a common foil as the rear wall. Or a common release sheet can be mounted on the container opening at the front surface, further simplifying.
[0031]
The overall shape of the multi-container front wall structure can take a variety of forms, but an essentially flat front wall structure provides advantages for manufacturing and delivery device design. The shape may be, for example, rectangular, square or circular. The circular "disc" shape has been found to be particularly beneficial, especially in connection with a delivery device that allows for the sequential feeding of containers into the firing position by simple rotation of a "revolver" type method, The lack of a special starting position makes it easier to handle and count the array and allows for an automatic centering feature.
[0032]
Most container types can be arranged in multiple arrays, if desired, and the starting step for any such arrangement will either bring a new container to the active injection site of the delivery device or create a new site. To a different container location.
[0033]
As shown, it is preferred to temporarily seal one or more openings in the container before actually injecting the liquid to maintain a completely sealed container. The seal should be broken or removed immediately before use. A breakable seal that can be broken by hand or with pressure can be used, but avoids detachment of any particles from the seal, has fully predictable dynamic behavior, and is more reliable and thicker It is often preferable to use a removable seal because it is possible to use a strong or strong layer. Generally, the seal can be formed integrally with the front wall, for example, by molding to leave a film of material somewhere in the open duct. However, a separate release layer is preferably provided for removal prior to injection and is preferably adhered to the front surface of the front wall. It is preferred to avoid glue or adhesive, and it is preferred that some form of welding be used, such as by ultrasound or heat. In order to facilitate removal and interference with the opening area, sealing can be performed on a limited area surrounding the opening. In a multi-container structure, making the layers individually removable for each container, for example by using a separate film, pre-cut film or separate tongs in a star shape for a circular disc Is preferred. Similar considerations apply to the material of the film as to the back wall material, but the film does not need to be deformable by stretching, and the small open area can slightly reduce the impermeability requirements. A starting step for such a container may be to remove the temporary seal before injection.
[0034]
(Opening)
The aperture design can vary depending on the nature of the liquid stream to be generated, for example, a spray or concentrate stream, to maintain consistency or to split into separate linear streams of drops. Also, the stream speed may vary from high penetration to low impact surface delivery. Several or multiple openings can be provided, for example to create a controlled shower, but for most applications a single opening is preferred. The aperture shape may be in the form of a simple tube, e.g., diverging to aid in the distributed spray, converging to assist in the stream being aligned to be formed, or venturi. It may be a combination such as a type channel. In high speed applications, it is generally preferred to shorten the duct portion of the opening to keep the flow friction low. The opening may be flexible, for example in the case of an infusion tube, but may benefit from precision if the opening structure is rigid. The opening can in turn be connected to the container via a tube, for example in the case of a supply tube, but it is preferred that the opening can be attached directly to the container. The opening is described herein as a terminal adapted to deliver the preparation to a target site, at or within the patient, for which purpose at least the last, ie, the frontmost, of the conduit. The part must be suitable for delivery to the site. Depending on the delivery mechanism used, the front end may not be designed to directly contact the target site, as in a liquid spray, where the front end is at a distance away from the target, or Orifices or openings for positioning on the target surface even though the true target is below the surface. In other cases, the front end is designed to penetrate into the target, as with a cannula or ordinary needle. The channel between the front and rear ends may be curved or bent for flexible infusion tubing or with a mounted permanent connection, but in many applications the needle on the syringe With respect to, it is desirable that the conduit be substantially straight.
[0035]
(Pump mechanism)
The mechanism for delivering the medicament through the container opening should basically include at least one type of pump mechanism, which is selected for the particular type or for the container and medicament used. There must be. The pumping mechanism may include any type of pressure source, such as mechanical or electrolytic pressure accumulation, in a suitable valve arrangement for the container and control, the method comprising substantially any type of container. And can be used with any type of product, for example by transcutaneous delivery by a liquid jet as exemplified by WO 94/2188, or by WO 88/09187 It is a regular tube infusion as illustrated. Either type of container can be used with peristaltic or centrifugal based pumps, but pumps based on controlled positive displacement are preferred for general use, especially liquid jets. US Patent No. 5,480,381 for use in the present invention, or a hand-operated needle-based device such as that illustrated by US Patent No. 4,564,360. A pump based on separate cylinder and piston action is preferred. Common syringe-type containers require a specially made pump system. The mechanism is suitable when it is desirable to accommodate many different types and sizes of syringes, but has its own piston rod, as exemplified by U.S. Pat. No. 4,978,335. By engaging and axially displacing the rod, it can be adapted to operate on a complete syringe, or the mechanism can be made smaller and more adaptable to portable devices. Has a somewhat direct action on the piston of a cartridge-type container, as exemplified by WO 95/26211, EP 143,895 or EP 293,958. With or without a rod. Also, dual or multiple chamber cartridges can use similar equipment for the various phases, as exemplified by WO 93/027720. The various pump mechanisms discussed may include a mechanical arrangement or piston that affects the medicament, but arrangements such as piston rods can be formed by any known means, such as gas pressure, vacuum, hydraulic, spring or manual. It may be activated by an operation.
[0036]
The mechanism may preferably include further components. The mechanism may include a special arrangement for ensuring the delivered dose, for example by directly metering the delivered drug, but for example, the axial displacement of the piston rod shaft in a manner known per se. Or it is generally preferred to use the pump mechanism for this directly or indirectly by monitoring rotation.
[0037]
The pump mechanism may include manual controls and form an interface between the user and the actual pump movement. In the case of stored energy, the control may take the form of a trigger, for example, releasing a valve or a mechanical lock. In the case of manual operation, the control may take the form of an actuator, which performs the pump movement, either directly or via a link system. Preferably, the link system incorporates a lever arrangement, e.g., if the preparation is to be moved out very easily, or if a reduced stroke length is desired, a manual force applied using the lever arrangement is applied. Although it may be reduced, it is preferred to use a lever arrangement to amplify the manual force or increase the stroke length for the actuator. Manual control may include common safety items such as arming locks or command requirements that make the device safe for children.
[0038]
Another known pumping mechanism is to pressurize a small cavity of liquid by rapidly and partially heating the liquid to form a vapor, or by compressing with a piezoelectric element. Alternatively, no pressure is applied, but the liquid adhered to the surface is injected by the vibration of the surface. Such techniques are used to deliver small droplets in rapid succession, for example in ink jet applications, but have also been proposed for processing purposes. The previously mentioned WO 96/06581 and EP 224352 disclose a piezo element and an electrostatic means for treating the eye, and the vibration technique is disclosed in EP 615470. No. 5,518,179 and US Pat. No. 5,838,350, the BubbleJet® technology for treating the eye is described in WO 94/03135. It is disclosed in the pamphlet. Such a pump mechanism can be used for the purposes of the present application, and in particular, for the delivery of small drops that may be desirable for ophthalmic treatment. In medical applications, for example, it is desirable to use the technique in combination with a single dose container to maintain good sterility as described.
[0039]
When applying the present invention with respect to a pump driver driven by hoisting energy, such a device will particularly well benefit from hoisting advantages, for example the possibility of using a rather fragile motor or manual input to be stored in the hoisting arrangement. To obtain, it is preferable to use a pump mechanism with relatively high force or high effect. For example, when using a ram to pressurize the piston / cylinder arrangement of a flexible or deformable container or suction / ejection system described above or a piston of a syringe-type device, for example, a rotational movement, preferably a translational movement, etc. It is also preferred to use a pump mechanism which is designed for a fairly simple movement pattern.
[0040]
Energy can be stored in the winding arrangement in different forms, such as electricity, magnetism, etc., for example, it is preferred to use pressure with a gas or hydraulic spring, most preferably mechanical energy, preferably mechanical It is a spring.
[0041]
Similarly, the energy input to the drive mechanism can take various forms. Energy may be manual. Alternatively, the stored energy can be used in any form, for example in the form described above, but the energy is preferably electric, for example delivered externally to the device or preferably mounted Battery, converted by any electromechanical device, such as a solenoid, or preferably by an electric motor.
[0042]
Preferentially, the transmission can be arranged somewhere between the energy input and the pump arrangement, for example to modify the power and to divide or sequence the energy for the starting step. Typically, the powertrain involves a gear down step from lower force to higher force. This transfer may occur after the hoist mechanism has stored energy, but preferably occurs prior to storage, typically allowing the energy storage to provide a higher force than the input force. Any known mechanism, such as a lever arrangement, screw and nut arrangement or gear train arrangement, can be used for the force change.
[0043]
(start)
As indicated above, various container types require different initiation actions. For example, syringe-type containers require onset piston movement for a variety of reasons, such as mixing of precursor components. The piston / cylinder arrangement requires suction from a vial or supply tube. A multi-container arrangement requires moving a new container into the active injection site, also referred to herein as an index. It is also necessary to remove the temporary seal, which is also referred to as peeling here. All possible starting steps shall not be repeated here.
[0044]
The additional initiation steps can be said to include control steps performed to avoid malfunction or to ensure that all conditions for a successful operation are present. Such a control step may be to check for the presence of a container in the container seat, check that the container is not yet used, e.g., not empty, and of the temporary seal before removal. It may check the presence and check the correct position, such as the door, closure, eyewash cup position, etc. Such a control step can be used to prevent a trigger or issue a warning unless all necessary conditions are met. Regarding the starting steps described above, some of such control steps can be made by microswitches or simple mechanical locks or catches, but where these controls require significant force or power. To the extent that exercise is required, these steps can be treated as starting steps below.
[0045]
The starting step may take place manually or with a separate drive system, but for the reasons outlined, it is advantageous to use the same drive mechanism not only for the winding step but also for at least one starting step. There is. Depending on the force requirements in the starting step, the gear down force is increased, and possibly a winding arrangement for the start may also be required in a similar manner with respect to the pump driver, and possibly the same arrangement for both purposes. Can be used for Alternatively, for example, if the force or speed requirements are not high, the steps can be driven directly without a hoist arrangement and a gear-up or gear-down transmission, or even if the transmission is not used. Good. The two actions often require different kinetic characteristics or are applied to different parts, requiring at least some different parts of the driver mechanism, which are often preferred.
[0046]
There are various alternatives to the ordering of actions, independent of the sharing of driver mechanisms. The winding action and at least one start-up step, for example winding and indexing, may take place and may occur simultaneously or at least partly simultaneously, for example to save time during operation. Simultaneous action may occur by movement of the same part for both purposes, for example when having one winding step for both, but preferably comprises different parts of the driver mechanism. In most cases, time is not critical, and it is preferable to perform the action, at least in part, in order to reduce the power and power requirements of the driver array of particularly valuable portable devices. More than one initiation step may be included in the equipment use cycle, for example, indexing, stripping and controlling, and then preferably at least two or more actions take place in sequence to amplify the above advantages It is.
[0047]
There is an ordering obtained without any active locomotion performed by the mechanism. For example, a single movable member may carry both a plunger or ram for injection and a release pin at the front, ensuring that the pin arrives before the plunger is active for injection. I do. Different arrival times can be obtained without parts located in the same part or driven by the same part of the driver mechanism. However, ordering usually requires some moving arrangement. Typically, the driver system needs to be disconnected from the hoist arrangement. This can be done by locking the hoisting arrangement in its hoisting state and freeing the mechanism by breaking the continuous movement or reversing the motor operation. Similar actions involving different arrival times can be used for ordering between several types of starting actions.
[0048]
(Operation control)
The operation of the device can be said to include the necessary steps for the ejection of the liquid, i.e. the starting step and the control step, if any, and any interaction thereof, such as sequencing as described above. . If the existing actuation arrangements, such as separate motor means and solenoid operated locking and blocking arrangements, are sufficiently complete to individually drive the various parts to the intended movement, control is best possible. It can be done entirely by software means for flexibility. Sensors or microswitches may also be needed at key points of motion to ensure operation in the correct spatial relationship between the parts. Control of such components can be performed by electronic components such as microprocessors with appropriate software.
[0049]
However, it is often preferred to provide a mechanical arrangement to assist control for the safest operation, whether the same motor means is used for different purposes, such as the winding and starting steps exemplified above. If necessary, it may be necessary. The mechanical movement arrangement can be easily arranged to be triggered by moving parts in important positions. Nothing prevents the use of combined software and mechanical arrangements for maximum safety and operational redundancy.
[0050]
Even if the main device functions are controlled mechanically, it may be beneficial to include electronic components for various secondary purposes, such as issuing an alarm or, for example, light, Signaling a warning or instruction message to the operator by sound, vibration or display message. Control of the display may also serve the purpose of informing the user, for example, of the timing between doses, the remaining dose in the case of multiple dose containers or multiple single dose containers, device status and the like. For example, to control compliance with a prescription, a processor and a memory could be used to remember the time and dosage administered, and possibly such data could be obtained from a device for further processing by external equipment, e.g., It can be downloaded from the EPROM mounted via the IR link.
[0051]
The various devices described may use stored energy in any known form, for example, electricity, gas pressure or gas release, or preferably, machinery, the latter being preferably Is a form of an elastic member such as a spring. The stored energy can be transmitted to a defined force via a corresponding conventional transmission, which may be, for example, an electro-mechanical, hydraulic, pneumatic, etc., electric motor or solenoid. Although a system, preferably a mechanical spring is used.
[0052]
Details regarding the use of sensors and signal processing in the device for the device are given below in connection with the description of the eyewash cup mobility, but the general principles given there are other components of the device. Because it is equally applicable to
[0053]
(use)
As shown, the features of the present invention have broad utility and can be used in a number of applications. The present invention provides a pump mechanism that is manually operated, for example, for a controlled start, trigger, force, speed, reset or sequencing, to some type of automatic operation typically involving the release of stored energy. It has particular utility for applications where replacement is desired. The invention has particular utility for applications with high liquid velocity requirements. Medical devices of this type are, for example, auto-injectors in which liquid injection occurs automatically after a trigger, and jet injectors in which penetration occurs by using liquid velocity instead of using a needle. For treatment of the eye, by ejecting a controlled amount of liquid from a pressurized chamber through a narrow orifice, the liquid is delivered quickly enough to precede the blink reflex and very small doses Quite rapidly liquid streams have been proposed for the purpose of allowing a smaller volume to be delivered than a gravity delivered drop. Ocular therapeutic uses are described further below.
[0054]
(Eye treatment)
A preferred use of the present invention relates to ophthalmic treatment of the eye with a drug. Common methods of administration are via eye drops or ointments, but have several advantages. Both methods generally deliver substantially greater amounts than can be absorbed by the eye, resulting in unreliable dosing and loss of expensive therapeutic agents, as well as unabsorbed preparations. Side effects can occur when the product is excreted via the nasolacrimal duct, for example, beta-blockers used in ophthalmic treatments have a substantially systematic effect. Another problem is that common modes of administration are prone to blink reflexes, which render the therapy completely useless or at least induce a high degree of uncertainty. Also, a common method is the ability to hit the glow portion of the eye, which does not provide a high degree of target accuracy, for example, the penetrable portion of the eye for prostaglandins. The principle used in the present invention solves these problems, inter alia, by its ability to deliver small volumes of liquid that are actively ejected and not determined by the surface tension of the liquid, which is sufficient to precede the blink reflex. The ability to deliver liquid at a precise rate and the ability to eject a concentrated and aligned stream for precise targeting. Exemplary parameters for this application are given below, but the invention should not be considered limited to such exemplary parameters. A typical single dose for delivery to the eye can be less than 25 microliters, preferably less than 15 microliters, and most preferably less than 10 microliters. Generally, the volume is at least 1 microliter, preferably at least 2 microliters, and most preferably at least 3 microliters. Since each container desirably contains a single unit dose, these figures also relate to the volume of liquid filled and contained in the container, and possibly the non-injectable amount of liquid such as wet film or liquid remaining in the container opening duct. Some overfilling is possible to make up, for example 25%, but preferably no more than 10%. In addition to the liquid, the container contains other materials, for example, a gas such as air or a purge gas or a noble gas such as nitrogen, for example, to facilitate manufacture, to aid in spraying or to act as a pressure buffer. In many cases, however, little or no gas need be present. The appropriate velocity of the stream of drops or jets to be ejected is, on the one hand, without the aid of gravity, straight across the air gap between the opening and the target and fast enough to travel fast enough not to be disturbed by blinking A balance must be struck between momentum and, on the other hand, momentum not fast enough to cause an inconvenient and perceptible impact on the eye. The ideal speed depends, in part, on the droplet size used, but in principle, the droplet can cross at least 1 cm, preferably at least 3 cm, most preferably at least 5 cm through the air by its momentum Should incorporate a reasonable distance between the opening and the target. A suitable low speed limit when leaving the aperture is 1 m / s, preferably at least 5 m / s, most preferably at least 10 m / s. Generally the speed is lower than 200 m / s, preferably lower than 100 m / s. The appropriate drop size defined in this way should be sufficient, for example, to be inhaled and not easily redirected without being too quickly decelerated, preferably having a minimum diameter of 20 microns. , Preferably at least 50, and most preferably at least 100 microns. Typically, the size is less than 2000 microns, preferably less than 1500 microns. The stream may take the form of a shower or spray of atomized liquid droplets, but preferably the stream is narrow and fairly consistent. However, even such streams tend to break up into individual droplets after a period of time. The above given values are intended for spherical droplets and, for multiple droplets, relate to the weight average of the particle diameter. The aligned stream tends to break into droplets approximately twice the diameter of the stream. Thus, a suitable opening diameter for the container is approximately one half of the given drop diameter, ie, between approximately 10 and 1000 microns, preferably between 20 and 800 microns. The above considerations are completely independent of liquid viscosity and tend to apply to both solutions and ointments.
[0055]
(Eyewash cup)
Many of the advantages provided by the present invention are available without the eyewash cup portion of the device, provided that the operator is responsible for the orientation and stability of the device. However, it is preferred that an eyewash cup portion be included to relieve the operator of these responsibilities. A suitable eyewash cup portion comprises at least a rim and a cavity.
[0056]
The purpose of the rim is to provide contact between the device and the face, and preferably also provides for automatic centering of the device to its intended position relative to the eye. The contact may be on any part of the face, such as the forehead, nose and cheeks, but generally good centrality is obtained when the rim contacts the orbit. "Rim" is to be understood in a broad sense as the point or points of contact and does not need to be shaped as an edge or other elongated part, but is distributed two-dimensionally for best centrality At least one point of contact, preferably two, three or several points, shall be provided. The points are preferentially shaped as one or several continuous edges, most preferably as continuous loops. For illustration purposes, it is assumed that a line can be drawn to connect the contact points into a "contact curve", which also represents the theoretical face contact points that are not actually touched by the rim, and represents the closed continuous rim. In that case the contact curve and the rim edge are assumed to coincide. The plane drawn to include the contact curve forms a theoretical “contact plane”. Lines drawn perpendicular to that plane form a "contact axis" and a "contact direction" along an axis from the device to the eye, in other words, from the cavity to the rim. The contact axis and contact direction are considered "symmetric" if they are centered within the contact curve, relative to the device, or radial relative to the eye relative to the patient. Shall be. Suitable rim configurations are well known in the art and are not critical to the present invention. It is preferred to use a left / right symmetric rim shape to make it equally usable for both eyes with similar grip. A rim having a contact curve in the form of a substantially ellipse, adapted for size and shape to the orbit, for example, can be used. The contact plane through such a substantially elliptical configuration may be flat, but is often slightly curved along an axis parallel to the minor axis of the ellipse. The rim, in a known manner, preferentially preferentially contacts at least the lower eyelid, preferably for the purpose of displacing or maintaining the eyelid, preferably also to the upper eyelid, preferably in the direction of contact. It may have a traction projection. Constructively, the rim can have a soft edge for comfort, preferably at least on any eyelid traction portion, preferably a high friction material. The rim may be integral with the cavity portion, but is preferably a separate portion attached to, glued or fused to the cavity portion for free material or color contrast selection.
[0057]
The cavity serves the purpose of providing space within the contact curve boundary for the protruding eye, ensuring the eye a safe distance to any part of its front, and in particular, providing an orifice as further described. Thus, a cavity is to be understood in a broad sense as any structure that meets these objectives. The cavity may be a genuine cup, such as a known eyewash cup, but does not have such a function, for example, having access to the orifice for opening and closing, avoiding preparation accumulation, washing, It is preferable to have a more open design in order to allow ease of manufacture, allow the assistant operator to visually monitor the orientation and delivery of the orifice, and facilitate manufacturing. The minimum requirement is that the cavity structure provide support and accessories for the rim, for example, providing a single arm or bar extending away from the rim in a direction opposite to the direction of contact, but with 2 One or several arms can be used, for example, in a cage-like design. As will be described in further detail below, the eyewash cup shall be arranged in the orifice of the container in such a way as to allow the fluid to be delivered to the eye and in particular into the contact curve of the rim. The relationship may depend on the delivery principle used, which is particularly free for drop delivery, but it is generally preferred that the orifice is positioned behind the contact curve when viewed opposite the contact direction. And the protrusions are along the contact direction in the curve. The orifices can be preferentially arranged into or within the cavity, preferably the components are parallel to the direction of contact, at least in the direction of fluid delivery. A constant safety distance is maintained between the orifice apex and the contact plane to prevent contact with the eyeball for any predictable individual anatomy and to prevent patient fear of such contact Is preferred, for example a distance of at least 5 mm, preferably at least 8 mm, most preferably at least 10 mm. The above-mentioned support and accessories of the rim via the cavity structure can be made in the container or its orifice, but it is preferred to attach the rim to the handgrip part, e.g. to replace the container unimpeded Enable.
[0058]
The eyewash cup may include spare features, such as mirrors, lights, etc., to assist in proper use, for example, detailing for fixation points for the eye.
[0059]
(Eyewash cup mobility)
When using an eyewash cup, it is preferred that it be arranged to move relative to the housing. The eyewash cup is preferably able to move between the two positions, i.e. an active position providing the above-mentioned safety distance between the opening and the eye, and a position closer to the housing, for example: Make the device more compact when inactive. The container opening can be fixed relative to the eyewash cup, e.g., it moves with the eyewash cup, but in most cases it is preferred that the eyewash cup move relative to the opening, which is then attached to the housing. A secure arrangement with respect to the container ensures that the option of exchanging containers or moving multiple containers to and from the active site is maintained. The eyewash cup can be moved into more positions, for example further away from the housing or opening than the active position, improving access to, for example, the eyewash cup or housing part. By preference, the eyewash cup can be removed entirely from the housing, for example for cleaning purposes. The mobility of the eyewash cup may be in any direction as long as the above requirements are fulfilled, for example, so that the eyewash cup contact direction has at least a moving component along the opening axis. The movement can be purely translational or have a rotating component, the latter preferably being obtained by a hinged arrangement for an eyewash cup or its accessories. At least some of the positions are well defined, for example by friction, snap locks, ball locks or fully releasable locks, preferably at least the active position and preferably also the rest position. Preferably.
[0060]
It is preferred to use a sensor or other arrangement to distinguish between the locations, preferably so that a signal is emitted from which the device may be used for operation. The signal may be distinguished between all possible positions in a continuous manner, but the sensor may for example separate signals at at least one position, preferably at least two positions, most preferably at least three positions. It is often preferable to emit. The signal can be of any kind, as long as it can transform it into a function, preferably an electromagnetic or mechanical signal.
[0061]
The signal received from the sensor may be or may be in the form of an electromagnetic signal representing the position described above. The electromagnetic signal may be based on electromagnetic radiation, such as an optical signal, but is preferably an electrical signal. Many components suitable for use as sensors are designed to provide such a signal output, but may otherwise be inserted into a circuit that ensures such an output. Any unique, integral or separate arrangement of this type may be considered as a converter that turns the sensor output into an electromagnetic signal. For example, one or more microswitches may be arranged along the translation path or rotation path of the eyewash cup, for example, on a cam surface arranged on a hinge axis.
[0062]
Similarly, the signal received from the sensor may be or may be in the form of a mechanical signal representing, for example, the position of a part that is connected to the movable eyewash cup and moves with it in some way. Any known transmission arrangement can be used as a converter to bring the signal to the desired kinetic effect, with the same considerations as the electromagnetic signal. There is nothing to prevent the electromagnetic signals being transformed into mechanical signals, or the mechanical signals being transformed into electromagnetic signals or being mixed in the signal chain.
[0063]
The signal thus received or converted can generally be said to be processed, for example, by a processor or transmission, and to emit control signals. The control signals are now used to control functional or operational components of the device. The operating components may be of any kind, but some typical examples are given below. Also, the control signal may be of any nature, depending on its future use, for example, mechanical, optical, etc.
[0064]
The control signal may be used to issue a message to the user, for example, to alert or alert the user to an inappropriate condition before the device is activated for delivery. The message may be a tactically sensible signal such as sound, vibration, a visual signal in the form of a warning light, or a more complex message on a display, or any combination of those messages. Is also good.
[0065]
Preferably, the control signals are used to control basic device functions with respect to actions taken by the operator. The control signal may be used to enable or disable the device, respectively, depending on the appropriate eyewash cup condition. The enabling / disabling may take place by a mechanical link or by an electromechanical link, for example by a relay device which interrupts a mechanical function such as a piston rod or a pump mechanism. It is advantageous to use this function in connection with a device having at least some automatic means for driving a device such as an electric motor whose operation may be determined by a control signal. It is even better that the device further comprises processing means for the control of the motor means, for example to ensure proper container control, initiation, sequence of action, dose, feedback of dosing data, etc. In some cases, an electromagnetic signal can be provided to the processor for additional flexibility, for example, only when the eyewash cup condition is satisfied, or when the start-up step is properly completed, or It only allows the processor to issue a motor activation control signal when the condition is reliably demonstrated in the self-control program. Existing processor units may now act as processors between the electromechanical signals and the control signals.
[0066]
The control signal is further used to actually trigger the device, i.e. the automatic function is started as soon as the sensor sends a predetermined position status signal. With regard to the above-mentioned active / inactive state, this triggering function is provided for purely mechanical drive means via an electromagnetic release mechanism, preferably together with electric motor means, most preferably with processor control automation of the device. Can be used.
[0067]
Preferably, the device is arranged to take at least one in the starting and firing order. A preferred arrangement is such that the device can be triggered only when the eyewash cup is in the active position or active. For example, a stationary position or state can be used to disable the trigger, put the device into a low energy consumption state, or start a new cycle of start steps. The third position may be used to signal a device state other than a quiescent or active state, such as a reset state or a container change state, and may include providing access to the container seat. Such movement, not just the eyewash cup position, is important and is also preferably used for action. For example, the device may act to move the eyewash cup to the active position when the start or control is successfully completed, or the device may be activated, for example, by using movement for the arming or winding mechanism of the device. , May be a passive receiver of motion input.
[0068]
Obviously, the above general sensor principles can also be used in devices for purposes other than eye treatment. The operation actually enabled or triggered may then be of a different nature. Possibly it is preferred that at least the injection be affected in a multiple dose device, possibly involving mechanical control of the delivered dose, preferably electrical control. In a jet injector, a sensor can be used for a contact trigger. In an auto-injector-type device, an automatic piercing step may be performed, preferably so that the sequence of automatic piercing and auto-injection is controlled, perhaps in the final needle retraction step. Autoinjectors are known which either deliver the preparation also during the piercing phase or can only be injected when the piercing is completed, and the invention is adaptable to both modes of operation. is there. In the case of multi-chamber cartridges with an overflow or bypass arrangement known per se, the injection procedure may incorporate the injection of different preparations in sequence, for example anesthetic followed by the active ingredient, or Next to the active element is the rinsing component.
[0069]
(Apparatus embodiment)
In the following, some considerations are given for the working examples, in which the device is of the type described above with reference to our co-pending application PCT / SE00 / 01514. , And especially in a common revolver-type disk layout.
[0070]
Delivery or ejection devices for such purposes generally have a housing with a seat for the container or container structure, and are capable of moving relative to the housing substantially axially relative to the container when in the seat. It can be said to comprise a possible ram and an actuator arrangement acting to drive the ram.
[0071]
The housing should include seats for one container or several containers, the minimum requirement being that at least the container to be emptied is kept fixed with respect to the ram, preferably so that the container shaft and The axis of motion of the ram is parallel, most preferably coaxial with the ram portion, and impinges on the rear wall of the container. Preferably, the seat should be able to accommodate a container with the features described herein. The seat preferably supports the container against advancing forces from the ram, preferably also against retraction and lateral forces. The seat should preferably allow the entire rear wall surface on the cavity to be exposed to the ram, exposing at least one or more openings on the front side of the container so as not to obstruct the liquid stream. However, the rigidity of the container of the present invention does not require any heavy support. Preferably, the seat is designed so that separate containers can be easily replaced, or a multi-container structure, for example by having a track on which the structure can be moved in one or two dimensions. Are designed to be able to be sequentially moved into the active position of the seat. In a preferred embodiment of the container arranged in a circular, preferably disk-shaped structure, it is appropriate to rotate the disk about the central disk axis to align the container in the active position in a revolver-type manner. It is. Such an indexing operation may take place as a starting step, for example, before or after winding the spring for the ram firing action. For single and especially multi-container arrangements, a guide device is provided to ensure good alignment with the ram axis to reach the intended high delivery accuracy, the guide device being, for example, in proper alignment Structures associated with each container on the package to cooperate with at least one corresponding locking structure on the housing or seat, or preferably on the ram, which are arranged in tandem. Locking in between may preferentially be coupled to a signal that assists in stopping in the correct position, for example, a tactile or audible signal in manual operation, or automatic operation Is a signal that can be detected mechanically or electronically at In addition, once again, manually or automatically, mechanically or electronically, keep track of the number of containers used or remaining, and warn of the reuse of already emptied containers. It is preferred to include a counting device designed to prevent or prevent.
[0072]
The ram may include an array of ram heads and pistons to move the ram head along the axis of motion. It is possible to design a ram head that does not match the container cavity, for example when using it with different cavity shapes or relying on the rear wall stretch properties to empty it, but it is designed to completely fill the cavity It is preferred to do so. This can be done with a flexible and adaptable ram head, for example for the purpose of being adaptable to different cavity configurations, to increase the operating range or to obtain a constant emptying pattern. Preferably, the liquid is squeezed out of the surrounding cavity part towards the central shaft part, which can be done, for example, by making the flexible ram head slightly shallower than that of the hollow container form of the cavity. However, for a single cavity configuration, the ram head front surface should be substantially identical to the inner cavity surface, or in other words, substantially identical to the rear surface of the front wall of the container space. Is preferred. The ram head can be surrounded by a support, for example a tube structure, in which the ram head moves, which preferably abuts around the cavity and at least during the collapsing movement of the rear wall between the ram head and the cavity Seal the space, for example to allow high pressure or reduce the risk of leakage. The piston portion of the ram is generally not critical to the operation of the injection, but is for propulsion and will be described in connection with the actuator system.
[0073]
The ram can be propelled by using various mechanisms and energy sources. The mechanism can be operated directly with manual energy, in which case it is preferable to perform a leverage or gear change and amplify or deform the force or speed, preferably to a low and high force. To have a controlled and consistent result, it is common to have an automatic function in the sense that propulsion occurs automatically and preferably irreversibly by using the stored energy after an operator triggers. It is suitable. Energy may be stored in any manner, for example, as a mechanical spring, a gas spring, a gas generator, or as electrical energy or a combination thereof. The energy is turned by a suitable motor or transmission device, for example, an electric motor or solenoid type motor for electrical energy, a piston and cylinder device for a gas spring or gas generator, respectively rotating for a coil or spiral spring, respectively. It may be transmitted to the ram by a shaft or plunger. It is generally preferred to include a transmission between the motor means and just the ram, for example, by using a gear or cam surface type transmission, especially to provide force amplification. Preferably, at least a part of the ram head and preferably the ram piston is prevented from rotating during forward movement, which is achieved by any known guide structure, such as a non-rotationally symmetric part cooperating with a complementary part. This can be ensured, the parts being respectively located on the ram and the housing. Suitable transmission components for propulsion of the ram are screw and nut arrangements, one positioned on the ram and the other positioned on the motor side of the transmission. The speed, force and kinetic properties required for the ram depend on a number of conditions, for example, the nature of the container parts and openings, the performance of certain applications such as surface delivery or penetration delivery, the preparation of preparations such as aqueous solutions or ointments. Viscosity, etc. and cannot be given a general description. However, the illustrated energy sources, motor means and power transmission can be adapted to each need. It has also been found to be beneficial to include a damper, for example, a dashpot, a linear damper, a flow valve, a magnetic damper, etc., to control the speed with a maintained steady force. For most applications, it is desirable to have a pressure spike and drop, which generally requires a stable, uninterrupted speed of the ram, which is facilitated, for example, by dampers or high inertia in the ram and transmission. .
[0074]
It is also preferred that the device include an arrangement that facilitates breaking or removing the temporary seal over the opening as described above. While it is possible to break the seal by the pressure itself created when the rear wall collapses, it is preferred to use an active step to break the seal. This can be done by a seal peeling tool arranged in relation to the housing, for example a penetrating tool for breakable sealing, or a wedge or stretching device for the removal of peelable sealing film. Such a device can be located at or near the seat, for example, if the seat area is jammed, it can be delayed or moved away. The seal removal tool can be operated manually or automatically or forcibly, for example, as part of moving the container to the seating site. However, it has been found to be beneficial to position the de-seal tool on the rear side of the container to move from the rear to the front, so that the de-seal tool on the film, i.e. on the rear side of the film, is in the best possible manner. Arrives and can be raised from the front of the front wall. In order to reduce the interference between the injection area and the injection target, the seal removing tool and mechanism can be more conveniently arranged in the housing at the rear of the container.
[0075]
The tool can be arranged on or relative to the ram in such a way as to move with the ram, using the same kinematic mechanism, removing just before the injection and as an inevitable part of the injection procedure To facilitate. Preferably, for the reasons outlined above, the tool can have its own movement mechanism. Preferably, the seal stripping tool proceeds through the opening in the front wall structure and possibly also through the rear wall where not occupied by the container cavity but covered by the sealing film. Preferentially, the dimensions of such openings and seal stripping tools can be adapted to each other to act as a guide arrangement for final alignment of the ram and cavity before actuation, as described above. . In operation, the tool first raises the film from the container opening, and then the ram head strikes the container back wall. These two steps can be performed in a single continuous movement for the ram, for example, for the simplest operation and the latest possible peeling of the seal, or for example, if the film is properly In order for the user to be able to demonstrate that it has been removed, it can be performed in a two-step operation, possibly requiring two trigger actions from the user. It is also interesting to use different kinetic characteristics for the two steps, for example a slow motion for peeling and a fast motion for ejection so as not to tear or break, which means that some movement arrangements It may be necessary, for example, for gearshifting, decoupling of brakes or dampers, etc. The general container design principle of the present invention strongly amplifies the above-mentioned advantages, in particular allows the use of the front wall for guiding purposes, and uses the outer area of the cavity part without instability problems By having the rigidity that allows it.
[0076]
The illustrated device can be adapted for different uses. Depending on the respective application, it is advantageous to equip the device with an arrangement that aids in aiming and positioning the target. For example, when used to project a liquid into the eye, the device may have an eyewash cup as described above. Penetration applications require a short distance or direct contact between the opening and the target surface, and possibly also an arrangement of devices that trigger with a constant contact pressure of the endpiece towards the target site. Larger surface treatments may require end pieces that define both angle and distance.
[0077]
(Method)
The above description has been made directly or indirectly, with reference to both structural and operational features, or arise from the description of structure, function, or purpose. The present invention is intended to incorporate and encompass both aspects and features of the described devices and methods. Methodological aspects are not repeated separately. Method aspects are also illustrated below with reference to the drawings. In another aspect, the injector of the present invention may be used in a conventional manner, ie, as described in the prior art.
[0078]
(Description of drawings)
FIGS. 1A to 1H are in the form of foil on the container opening, using the mounted electric motor to wind up the pump driver of the pump mechanism during contraction of the release pin at the final index of the disk container. Fig. 3 shows a device in which a peeling pin moves forward to detect and ultimately remove a temporary seal.
[0079]
FIG. 1A shows an exploded view of the components of the device. The apparatus 100 can be said to include a housing 110 having an upper body 111, a lower body 112, and an externally accessible trigger 113. The housing also comprises a door 114, which can be opened when the eyewash cup is in a remote position, into which a disc 116 can be inserted or a plurality of containers 117 with openings 118 and peel holes 119. It is for replacement. The movable eyewash cup 120 comprises a rim 122 attached to an arm 124, the arm 124 being connected at its other end to a hinge shaft pin 123 supported by bearings 128 and 128 ', the bearing being a cam part moving with the eyewash cup. (Not shown), this cam portion affecting the described in-line arranged sensors. The housing further comprises a window 124 and a battery closure 125 on the display.
[0080]
The interior of the housing includes an upper chassis portion 126 and a lower chassis portion 127 to carry the device mechanism. The mechanism includes a drive mechanism, generally designated 130, a power transmission device 140, a pump mechanism 150 with a device for stored hoisting energy, a peeling mechanism 160, an indexing mechanism 170, and an electronic component. And a control system 180 that includes the board 181 of FIG.
[0081]
The drive mechanism 130 includes a battery (not shown) having a rotating shaft with a front encoder 132 for counting motor rotation and outer threads 133 for cooperating with the upstream gear of the power transmission chain. It can be said that the motor 131 is included. The motor and a detector for rotating the motor are mounted on the electric board 181.
[0082]
The transmission 140 can be said to comprise a set of gears in a gear train arranged to gear down the motor speed and increase the force to accommodate each function. The stripping wheel 142 is arranged to drive a stripping mechanism, the intermediate wheels 143 and 144 are part of a gear train without any additional functions, and the hoisting wheel 146 is configured to drive a hoisting mechanism for a pump mechanism. Are arranged. See also FIG. 1H for details.
[0083]
The pump mechanism 150 can be said to include a lever 152, which can rotate about the lever axis 153, allowing its end at the eyewash cup end of the housing to move up and down. At the other end of the lever is a damper accessory 154. The damper accessory is connected to the piston part of the damper 157, the cylinder part of which is arranged stationary. In this arrangement, the piston is moved against a vacuum to evacuate air into the cylinder to slow the speed of the ram impact. The pump mechanism includes a ram 158 that is rotatably connected to the lever at 159 and is guided by the chassis, allowing the ram to arrive at the deformable rear wall of the container in substantially straight motion. Using the downward movement of lever 152, away from the eyewash cup in the position shown, winds spring 156 of the pump mechanism. The hoisting spring is arranged to throw a ram toward the container 117 when ejected and eject liquid through the opening 118. As best seen in FIG. 1H, the lever includes a nut 151 and is provided with inner threads (not shown), with outer threads cooperating with a corresponding thread associated with the screw and a power transmission device. With the hoisting wheel 146. The nut is mounted on the lever and can move the lever up and down depending on the motor direction. The nut is attached to the lever and catches it only in the hoisting direction, not in the releasing direction. A spring-biased L-shaped ram lock 155 is arranged to go beneath the lever 152 and, when in the rolled-up position, retains it there until release. After motor reversal, the nut may move freely from the lever in the release direction, but will eventually hit the L-shaped lower leg, which will release the ram lock and throw the ram, which will cause the peel pin 162 to release its ram. Occurs when the forefront position is reached, and thus complete stripping is achieved.
[0084]
The peeling mechanism can be said to include a peeling pin 162 which is keyed to the chassis at 164 to prevent rotation and to engage inner threads 166 to cooperate with outer threads on the peeling wheel 142. To allow the motor to move up or down. Obviously, in this embodiment, the motor and transmission drive the release pin directly, rather than a hoisting spring or similar energy storage. At the end of the forward peeling movement, the pump mechanism is activated and throws the ram by releasing the ram lock 155 in the manner described above. On the rear side of the peeling wheel 142 is a force sensing sensor 168 arranged to switch with a constant opposing force from resistance, and the peeling pin must break when the temporary sealing foil is peeled off. This allows the control system to prove its existence.
[0085]
The indexing mechanism 170 includes an indexing wheel 172 to cooperate with a correspondingly shaped container disk hub, the teeth corresponding to an equal number of containers on the disk. The indexing wheel has a constant mobility and is spring loaded to facilitate connection to the disc. At the other end of the indexing wheel is a toothed inner catch wheel 173 and an outer catch wheel 174. The incremental arrangement is driven by the key 164 of the peel pin 162, which in a backward movement affects the tapered surface 176 of the axial lever 175, which in turn affects the radial lever 177, which It makes hook contact with the inner catch wheel 173 and rotates one tooth of the indexing wheel. The counter lever 178 is in spring biased hook contact with the outer catch wheel, preventing the index wheel from rotating in the opposite direction. The indexing corresponds to one tooth after the injection of each operating cycle and aligns a new container with the ram. This is an incremental action that is initiated when the peeling pin arrives at a position far away from the eyewash cup portion of the device during backward movement, at which point the pin is withdrawn from the peeling hole in the disc to allow its rotation To This effect is also detected by a counter sensor (not shown), which is used by the processor on board 181 to reduce the number of doses displayed remaining on the display. The processor is also arranged to prevent triggering after the entire dose of the disc has been ejected or when a defective container is detected, and then moves the peel pin to its rearmost position, which is Trigger the replacement door to open.
[0086]
As shown, most electronic components are positioned on electronic board 181. In addition to the features described above, the control system 180 may include a display 182, also connected to the board, and a door locker 183 with an arm 184 that affects a door sensor 188 depending on the position of the door. be able to. Further, sensors 185 and 186 cooperate with the above-described cam surface of bearing 128 'to detect eyewash cup position. Switches 189 are arranged in chassis upper portion 126 affected by trigger 113. Processor 187 is arranged for operation of the device.
[0087]
1B to 1F show various phases of device operation. FIG. 1B corresponds to the standby position immediately before the injection cycle. The release pin 162 is in an intermediate position just behind the foil to be removed. It should be noted that the winding spring 156 is already in the winding state, this winding occurs early during the backward movement of the peeling pin and the damper 157 is in its initial position. In the foil touch position shown in FIG. 1C, the trigger has been actuated and the motor has moved the peel pin forward a small distance, at which point it has penetrated the peel hole 119 in the disc, touched the foil and touched the sensor 168. Demonstrate its existence via. In the peel position of FIG. 1D, peel pin 162 has completed its forward motion and has removed the foil. In the injection position of FIG. 1E, at the forefront of the peel pin, the ram lock 155 is released, which triggers the ram 158, completing the injection at the position shown. The lever 152 moves to the upper right in the figure under the influence of the hoist spring 156, and moves to the lower left when the piston of the damper 157 is withdrawn. In the starting indexing position of FIG. 1F, the device is re-wound during the return movement of the peeling pin by reversing the motor again, the peeling pin being in a further rearward position than in FIG. The indexing of the disc is started during the further backward movement. During the second half of this backward movement of the release pin, the indexing of the disk is completed. By reversing the motor again, the peel pin can move forward to the standby position shown in FIG. 1B. If the trigger 113 is pressed and the eyewash cup 120 is in the illustrated active position, the device is ready for a new injection cycle in this position. Alternatively, as shown in the open cover position of FIG. 1G, the processor moves the peel pin to a position further back than the start indexing position shown in FIG. 1F, which allows the disc to be changed. Release the mechanical lock for the door 114, which also requires that the eyewash cup swing about 180 degrees away from the position shown. This occurs when all containers of the disc have been used or when a defect has been detected.
[0088]
The use of the device is described from a start position where the device is in a standby position, as shown in FIG. 1B. When the eyewash cup is in the rest position (not shown), it needs to be moved to the active position shown in order to operate the device. The display may show the alert signal, for example, by a flash. The eyewash cup is placed against the eye and the trigger is actuated, which is only possible when the eyewash cup is in the active position, which is described above until the device is again in the state of FIG. 1B. The action initiates the complete sequence of peeling, injection and indexing in a forced manner. Alternatively, the triggering action only advances the device to a complete peeling of the foil as illustrated in FIG. 1D. A new triggering action is then required to complete the injection as shown in FIG. 1E and either automatically proceeds to full completion as illustrated in FIG. 1B or to the open cover position of FIG. 1G. . The second trigger shall occur within a certain time frame from the first trigger, otherwise the processor will automatically proceed to the end and the dose will be lost. This is so as not to risk the contamination of the container after opening. When all doses have been consumed, the processor operates the motor to drive the peel pin to its rearmost position shown in FIG. 1G for disc replacement. After a new disk is detected, the processor moves the peel pin to the park position shown in FIG. 1B and the dose counter is reset.
[0089]
2A to 2C show a modified appearance of the device compared to that of FIG. 1, and the following description focuses mainly on the differences. The device of FIG. 2 is generally mechanical and is arranged to be operated by manual energy, which is applied to the device by manually pushing the eyewash cup from a position farther to a position closer to the housing. It is passed on and the energy is stored as hoisting energy in the spring of the device. In FIG. 2, the device is shown in an active state before firing, i.e. after manual energy has been input, and the eyewash cup is ready for firing in the active position.
[0090]
The apparatus 200 can be said to include a housing 210 having an externally accessible trigger 212 connected to a start pin 214 and a lock pin 213. The housing also comprises a door 214, which can be opened when the eyewash cup is in a remote position, into which a disc 216 can be inserted or a plurality of containers 217 provided with openings 218 and peel holes 219. It is for replacement. The eyewash cup 220 comprises a rim 222 attached to an arm 224, the arm 224 being connected to a hinge at the other end, and a rotating shaft penetrating into the housing and connected to the mechanism. The mechanism can be said to include a drive mechanism, indicated generally at 230, a hoisting mechanism 240, a pump mechanism 250, a peeling mechanism 260, an indexing mechanism 270, and a control system 280.
[0091]
The arm of the eyewash cup is connected to the drive mechanism partial wheel 232, which clearly transmits the same rotation to the driver wheel 236 via a “locomotive” link 234. The driver wheel is connected via a freewheel system 238 to the hoisting wheel 242 of the hoisting mechanism 240, allowing simultaneous rotation of the wheel when rolling up the device by pushing the eyewash cup toward the housing, but with opposite rotation. Sometimes arranged to free the hoisting wheel from the drive wheel. The drive wheel has an extension with a slot 239 arranged to cooperate with the locking pin 213 of the trigger, so that the trigger, and thus the eyewash cup, is such that the driver wheel is flush with the slot. It can be pushed at some time and appears when the eyewash cup is in the active position, but not when the locking pin is in the extension outside the slot.
[0092]
The hoisting wheel 242 of the hoisting mechanism is connected to a lever 244, which can rotate about a lever hinge (not shown) as at the end of the embodiment of FIG. The edge can be moved up and down. The other end 246 of the lever is connected to a damper as in FIG. The downward movement of lever 244, away from the eyewash cup in the position shown, is used to wind up the separate springs of the pump and peel mechanisms.
[0093]
The pump mechanism 250 is substantially symmetric about the device midline, includes a ram 252 and a pump spring 254, and, when released, projects the ram toward the container 217 and ejects liquid through the opening 219. Are arranged.
[0094]
Peeling mechanism 260 is also substantially symmetric about the device midline, and also includes a peeling pin 262 and a peeling spring 264, which are arranged to project pins toward disk 216 when released, and The pins are pierced through release holes 219, thereby removing the temporary seal film. Release occurs when the transfer hook 266 is released by the action of the trigger 212 via the start pin 214 and the intermediate transfer locker 268. When this occurs, the hoisting wheel is allowed to rotate in the opposite direction compared to the hoisting motion. At the end of the stripping movement, the pump mechanism is activated and the ram is thrown.
[0095]
The indexing mechanism 270 includes an indexing wheel 272 to cooperate with a correspondingly shaped container disk hub, shown here with 14 teeth corresponding to an equal number of containers of the disk. The indexing wheel is connected to the incremental array 274 and is arranged to rotate the indexing wheel and the disc at an angle corresponding to one tooth. This is an incremental action initiated when the peeling pin arrives at the furthest position relative to the eyewash cup portion of the device during winding of the device, at which point the pin is pulled out of the peeling hole of the disc and its rotation Enable. This action is also transmitted to the counter disk 276, which is also incremented and shows a new remaining dose figure in the housing window and also on the gear 278, which is given an incremental rotation. The gear has bolts 279, which, after injection of 14 doses, contact the transmission rocker 268 to reduce the transmission hook from the driver wheel, thereby moving the eyewash cup to a position far beyond the active position. And then allow the door to open for disk replacement.
[0096]
The use of the device is described from a starting position in which the device is rolled up and the eyewash cup is in the closed rest position, where the locking pin 213 is outside the slot 239 and the trigger cannot be pressed. The eyewash cup is moved to the active position, where the trigger can be pressed. The eyewash cup is placed against the eye and the trigger is activated, which initiates the complete sequence of exfoliation, ejection, and indexing in a manner forced by the action described above. Upon release of the trigger, the driver wheel 236 is free, so that the spring associated with the eyewash cup and the driver wheel automatically moves the eyewash cup to a position about 30 degrees away from the housing, causing the eyewash cup to roll up. Prompt the user to perform The user pushes the eyewash cup to the closed rest position, which rolls up the device, indexes the disc at the end of the sequence and increments the counter. The eyewash cup is locked in the rest position until it actively moves to the active position for the repetitive cycle. Once 14 doses have been taken, the eyewash cup is not locked and can be moved to a distant position, where the door can be opened for disk replacement.
[0097]
The invention is not limited to the described and illustrated embodiments, but can vary within the scope of the claims.
[Brief description of the drawings]
[0098]
FIG. 1A is an exploded view showing an embodiment apparatus that uses a disk having a plurality of single dose containers designed to be powered by a battery and an electric motor and pressurized by a ram.
FIG. 1B is a cross-sectional view of the device during a five-operation phase of an embodiment using a disk having a plurality of single-dose containers designed to be driven by a battery and an electric motor and pressurized by a ram.
FIG. 1C is a cross-sectional view of the device during a five-operation phase of an embodiment that uses a disk having a plurality of single-dose containers designed to be powered by a battery and an electric motor and pressurized by a ram.
FIG. 1D is a cross-sectional view of the device during a five-operation phase of an embodiment using a disk having a plurality of single-dose containers designed to be powered by a battery and an electric motor and pressurized by a ram.
FIG. 1E is a cross-sectional view of the device during a five-operation phase of an embodiment using a disk having a plurality of single-dose containers designed to be driven by a battery and an electric motor and pressurized by a ram.
FIG. 1F is a cross-sectional view of the device during a five-operation phase of an embodiment using a disk having a plurality of single-dose containers designed to be powered by a battery and an electric motor and pressurized by a ram.
FIG. 1G is a cross-sectional view of the apparatus during a five-operation phase of an embodiment that uses a disk having a plurality of single-dose containers designed to be powered by a battery and an electric motor and pressurized by a ram.
FIG. 1H shows the components of the main lever in more detail.
FIG. 2A is an open view schematically illustrating an alternative embodiment of the entire machine arranged to be hoisted by manual energy.
FIG. 2B is a cross-sectional view schematically illustrating an alternative embodiment of the entire machine arranged to be hoisted by manual energy.
FIG. 2C is a cross-sectional view schematically illustrating an alternative embodiment of an overall mechanical arrangement arranged to be hoisted by manual energy.

Claims (44)

An apparatus for injecting a liquid stream toward an eye, said stream moving from a proximal position to a distal position, the apparatus comprising: a) a housing; b) a container for the liquid; c. A) at least one opening arranged to eject the stream and in fluid communication with the container; and d) discharging at least a portion of the liquid from the container through the opening to form the stream. An apparatus comprising: an operable pump mechanism; and e) an eyewash cup having a contact surface arranged to contact the eye or its periphery. And at least two positions: i) an active position where the eyewash cup contact surface is at a defined safe distance to the opening; and ii) the eyewash cup contact surface is the active position. A movable position between a stationary position in a more proximal position than the position, and a sensor arranged to be able to distinguish between the positions. An apparatus characterized by an improvement. The apparatus of claim 1, wherein the opening is fixedly arranged with respect to the housing when moving the eyewash cup. The apparatus of claim 1, wherein the container is removably attached to the housing. The device of claim 1, wherein a plurality of single dose containers are connected and arranged to be sequentially moved into a working position relative to the pump mechanism. The apparatus according to claim 1, wherein the eyewash cup is arranged to be movable to at least one further position further from the housing or opening than the active position. The device according to claim 1, wherein the eyewash cup can be entirely removed from the housing. The device of claim 1, wherein the eyewash cup is arranged to move in a translational motion. The device of claim 1, wherein the eyewash cup is arranged to be moved by a rotating component. 9. The device according to claim 8, wherein the eyewash cup is connected to the housing via a hinge. The sensor system is arranged to generate at least one signal, and the device is arranged to perform at least one action based on the signal, either directly or after processing into a control signal. The apparatus of claim 1, wherein: The apparatus of claim 10, wherein the signal generation or processing includes at least one mechanical step. The apparatus of claim 10, wherein the signal generation or processing includes at least one electromagnetic step. The apparatus of claim 10, wherein the sensors are arranged to generate a signal representative of successive eyewash cup positions. The apparatus according to claim 10, wherein the sensors are arranged to generate signals representing separate eyewash cup positions. The device of claim 1, wherein the device is arranged to send at least one message detectable by a user based on the signal. Device according to claim 1, characterized in that the device is arranged to perform at least one operating step of the device. The apparatus of claim 15, wherein the signal is used to enable or disable the pump mechanism. 16. The device according to claim 15, wherein the device can be triggered only when the eyewash cup is in the active position. 16. The apparatus of claim 15, wherein the signal is used to disable or enable a start action for the container. 16. The device of claim 15, wherein the signal is used to enable or disable device control actions. The device of claim 15, wherein the signal is used to enable or disable a device door. The apparatus according to claim 1, wherein the eyewash cup is arranged to be movable with respect to the opening. The apparatus according to claim 1, wherein the eyewash cup is arranged to be movable with respect to the housing. A method for operating an injection device for injecting a liquid stream, the stream moving from a proximal position to a distal position, the device comprising: a) a housing; b) a container for the liquid; c) at least one opening arranged to eject the stream and in fluid communication with the container; d) delivering at least a portion of the liquid from the container through the opening to form the stream. And e) a portion arranged to define a predetermined distance to a target, said at least two positions relative to said opening or said housing, i) said portion being in said opening. A part arranged so as to be able to move between an active position at a defined safety distance to the active position and ii) a rest position at which the part is more proximal than the active position. Moving the portion between the active position and the rest position and back, wherein the sensor is arranged to be able to distinguish between the positions. Generating a signal representative of either a position or the rest position; optionally processing the signal to obtain a control signal; and using the signal or the control signal, the container, the opening, Performing at least one action on the pump mechanism or the portion. 25. The method according to claim 24, characterized by any steps included in any other claim. An apparatus for injecting a liquid stream, the stream moving from a proximal position to a distal position, the apparatus comprising: a) a housing; b) a container for the liquid; An at least one opening arranged for ejection and in fluid communication with the container; and d) a pump mechanism, the pump driver being capable of storing hoisting energy to drive the pump mechanism. Pumping at least a portion of said liquid from said container through an outlet and operable to form said stream; and e) starting said device for liquid delivery separately from said pumping mechanism. At least one actuating mechanism operable to actuate manual or stored energy, i) hoisting said pump driver The Nerugi, and, ii) to direct energy or stored energy for operation the operating mechanism, characterized improvement comprising an array of the drive mechanism to convert, device. 27. The apparatus according to claim 26, wherein the hoisting energy is at least partially stored in one or more mechanical springs. The device of claim 26, wherein the drive mechanism is arranged to receive manual energy. The device of claim 26, wherein the drive mechanism is arranged to receive stored energy. Device according to claim 26, characterized in that the stored energy comprises electrical energy, preferably electrical energy of a battery. The device of claim 26, wherein the drive mechanism comprises a power transmission. 32. The device of claim 31, wherein the transmission is arranged to perform a gear down from a lower force to a higher force. 27. The apparatus of claim 26, wherein the actuation mechanism is arranged to drive an indexing action that causes a container to be in operative relation to the pump mechanism. 27. The apparatus of claim 26, wherein the actuation mechanism is arranged to effect a peel in which a temporary seal is removed from the container. 35. The apparatus of claim 34, wherein the peeling action comprises moving a seal peeling tool through a disk member having a plurality of containers. 36. The apparatus of claim 35, wherein the stripping action includes checking for the presence of a temporary seal prior to removal. 27. The apparatus of claim 26, wherein the drive mechanism is arranged to hoist with stored energy to drive the actuation mechanism. 27. The apparatus of claim 26, wherein the drive mechanism is arranged to hoist with stored energy to directly drive the actuation mechanism. 27. The apparatus of claim 26, wherein the drive mechanism is arranged to drive the hoist mechanism and the actuation mechanism at least partially in sequence. 40. The apparatus of claim 39, wherein at least two actions are driven by the drive mechanism, and wherein the at least two actions are driven at least partially in sequence. 27. The device according to claim 26, wherein the actuation mechanism is arranged to drive a control step and / or a start step for the container or the opening. 27. The device of claim 26, wherein the device comprises an eyewash cup with a contact surface arranged to contact the eye or its face. A method for operating an injection device for injecting a liquid stream, the stream moving from a proximal position to a distal position, the device comprising: a) a housing; and b) a container for the liquid. C) at least one opening arranged to eject the stream and in fluid communication with the container; and d) a pump mechanism, which can store hoisting energy to drive the pump mechanism. A pump mechanism that includes a pump driver and is operable to pump at least a portion of the liquid from the container through an outlet to form the stream; and e) separate from the pump mechanism for the liquid delivery. At least one actuation mechanism operable to initiate said device of claim 2, wherein i. The winding energy of lamp driver, and, ii) to direct energy or stored energy for operation the operating mechanism, characterized in that it comprises a step of operating the drive mechanism to convert, process. 44. The method according to claim 43, characterized by any of the steps included in any of the other claims.

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