RU2575310C2 - Injector - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medical equipment, namely injectors. An injector comprises a body, an in-built container holder, a drive assembly and a rotary mechanism of injection indication. The container holder is configured to comprise a drug container having a needle attached to one end thereof, and a piston stopper hermetically configured to slide inside the above drug container from the other end thereof. The drive assembly comprises a piston rod and a piston drive unit configured to slide in the relation to the piston rod; a piston drive unit is blocked from rotating about the piston rod, however configured to rotate about the body. The drive assembly additionally comprises a first energy storage unit integrated into the injector body and configured to accumulate and store energy. The piston drive unit is operatively connected with the first energy storage unit, wherein the piston drive unit is releasable so that an output torque from the above first energy storage unit enables the piston drive unit to rotate; whereas the piston rod pushes through towards a proximal end of the injector thereby an injection is performed. The rotary mechanism of injection indication is configured to indicate an injection progress for the user; the above rotary mechanism of injection indication comprises a signal element and a driving mechanism for rotary actuation of the above signal element. The driving mechanism is connected to the piston drive unit on the distal end of the above piston drive unit; the rotary mechanism of injection indication is mounted so that the injection progress is indicated, e.g. through at least one opening formed in at least a distal end surface of the body.

EFFECT: structural improvement.

22 cl, 14 dwg

Description

FIELD OF TECHNOLOGY

The present invention relates to an injector having several automatic functions, such as automatic penetration, automatic insertion and automatic safety means to prevent accidental injuries from needle sticks, and in particular, to an injector adapted to handle medicinal preparations in fluid form having high viscosity.

BACKGROUND OF THE INVENTION

The present invention relates to injectors for the administration of fluid drugs having a high viscosity, which means that these devices require great efforts in order to push the fluid through the needle with the introduction of the specified medicinal product.

Automatic injectors, or pen syringes, went on sale for many years. One of the first automatic injectors was developed for wartime and was activated by pressing the injector on a part of the body to activate it. The main task was to administer the drug as quickly as possible, and the patient and safety issues were not cared for much. In recent years, several drugs have been developed, such as those that are to be administered by patients on their own. Therefore, depending on the intended use and type of medication, injectors have also been developed that have automatic functions to varying degrees in order to facilitate the administration of medications in a reliable and safe way for patients, including trained personnel, such as doctors and nurses.

Automatic injection devices having an automatic insertion function often include a housing, a coiled compression spring acting on the piston rod, which in turn acts on the piston travel stop inside the drug container to expel said drug through a needle attached to said container. In most cases, one end of the spring often abuts against the inner surface of the end of the housing, which means that the housing must be sized in accordance with the stiffness of the spring. When fluids with high viscosity are to be introduced using an automatic injector, great efforts are required to displace the drug through a thin needle. As a result, the spring becomes very large both with respect to the diameter of the coil spring, and with respect to the diameter of the turns of wire. The size of the spring means that the device is becoming large, and for some applications and some consumers, devices of this size are unacceptable.

In addition, in particular, if the administration of the drug takes a long time, for example, when administering a highly viscous liquid and / or using a needle having a small diameter, it is desirable for the user of the injector to know whether the injection is still ongoing or not. In more detail, the user who is taking the medicine on his own needs to know when the injection is completed and you can safely remove the injector from the injection site.

WO 2010/066592 discloses an injector comprising an injection indication mechanism having an elastic band on which various indications are arranged. The housing contains a hole through which these readings can be seen. The specified tape has a first end connected to the drive device of the injector. When the drive unit is unlocked, the tape passes the indicated hole.

Additionally, prior art is presented in document WO 2004/020028. It discloses an injector having a closed tape with a scale. With the introduction of the product, the required dosage is set on the injector by rotating the rotary knob. This moves the tape with the scale in accordance with the set dosage, so that as soon as the rotation setting the dosage is completed, the corresponding dosage unit can be displayed through the window. Such a tape with a scale for indicating dosage, however, does not illustrate the progress of the injection.

An injector having a strip indicator proposed in WO 2004/020028 is, however, difficult to assemble. In addition, the movement of the tape is visible to the user in only one direction or at one angle of view (or in a small range of angles of view). Moreover, slow injections can be difficult to determine for the user.

SUMMARY OF THE INVENTION

In order to overcome one or more of the above problems, an injector is proposed in accordance with the independent claim 1.

Further aspects, improvements and changes are disclosed in the dependent claims, in the drawings and in the description.

In this application, when using the term "distal" we are talking about the direction pointing in the opposite direction from the injection site of the drug dose. When the term "distal part / distal end" is used, it means the part / end of the administration device or the parts / ends of its elements that are located farthest from the injection site of the drug dose. Accordingly, when using the term "proximal" we are talking about the direction pointing towards the place of administration of the drug dose. When the term "proximal part / proximal end" is used, it means the part / end of the administration device or the parts / ends of its elements that are closest to the place of administration of the drug dose.

An injector in accordance with the present invention includes a housing and a container holder located inside the housing. The container holder is configured to hold a container for a drug.

The specified housing may include a proximal part of the body, the distal part of the body, the proximal intermediate part of the body and the distal intermediate part of the body. In the assembled state of the injector, the proximal part of the body, the distal part of the body and the distal intermediate part of the body can form the outer surface or the outer side of the injector. However, the invention also encompasses configurations in which the housing includes fewer housing parts or additional housing parts. Parts of the housing may have a generally cylindrical configuration, such as a round, elliptical or square, or substantially square cylindrical configuration.

A removable front cap may cover the proximal opening of the body.

In a preferred embodiment, the proximal intermediate part of the body is aligned with the proximal part of the body and the distal intermediate part of the body, so that it overlaps with both of them to form a bonding structure for connecting the two parts together. The outer surface of the proximal intermediate part of the body and the inner surfaces of the proximal part of the body and the distal intermediate part of the body, respectively, can thus be provided with engagement structures. Such connecting engagement may be provided by ring-shaped groove-rib structures and may be detachable.

However, this invention also covers the case where the proximal part of the body and the distal intermediate part of the body are connected using other connecting structures that do not require a proximal intermediate part of the body.

The distal intermediate part of the body can have a stepped configuration, which in the axial direction looks so that its proximal part forms a part of the outer side of the injector, while its distal part has a smaller cross-sectional area relative to the cross-sectional area of the proximal part, so that the proximal end of the distal part of the body can overlap with this part having a smaller cross-sectional area to connect the distal intermediate part of the body and the distal part enclosures with each other. In this case, ring-shaped structures of the groove-rib type can also be provided as a connecting mechanism.

However, as an alternative, the distal intermediate part of the body may not have a stepped configuration, but instead, at its distal end, the same cross-sectional size and shape as the distal part of the body. In this case, the distal intermediate part of the body and the distal part of the body can be connected to each other, for example, by means of a coaxial sleeve located outside or inside these parts and partially overlapping with both of them.

The drug container holder preferably has at least its proximal part inside the proximal part of the body. The drug container holder may include one or more guides of the container holder. Preferably, said container holder rails are arranged longitudinally on opposite outer sides of the container holder. The guides of the container holder fit into the corresponding groove structures provided on the inner surface of the proximal part of the body, so that the drug container holder has the ability to move and be guided in the axial direction relative to the body, but is blocked against rotation relative to the body, in particular relative to the proximal part of the body.

The drug container is an auxiliary component of the injector since it can be inserted into the injector by the user, for example, by replacing an empty drug container after using the injector. In addition, the injector is optionally delivered in a fully assembled state, that is, with a drug container already placed inside the injector upon delivery of the injector.

The drug container may be a widespread drug container having a needle attached to one end thereof and a piston travel stopper that is hermetically sealed to slide inside said drug container from the other end thereof.

In a preferred embodiment of the invention, the housing, for example the proximal portion of the housing, comprises at least one window. This window can be positioned axially, occupying some part of the body length. In a further preferred embodiment, more than one, for example, two such windows is provided. In the case where there are two windows, they can be on opposite sides of the proximal part of the body. Such a window allows the user to see the injection stage, that is, whether the injector is still at the initial stage when the drug is not yet administered, or if the container for the drug is already empty. Through this window (s), the user can see the container for the medicinal product, placed at least in the proximal part of the body. Moreover, in the state when the drug is displaced, the user can see the piston rod through the window.

The injector may further include a tubular protective case or needle cover that slides in the proximal portion of the body and is capable of acting on the locking means of the container master device when said tubular protective needle case is pressed against the injection site. The tubular protective needle case initially covers the needle of the drug container. Thus, the needle is closed or retracted until the injector is actuated and it cannot be accidentally touched until this point. The tubular protective case for the needle is configured to move between the proximal and distal positions. The tubular needle protective case is preferably contacted and biased when the injector is placed at the injection site. On the other hand, a removable front cap on the proximal opening of the body prevents accidental displacement of the tubular needle protector before using the device.

From the distal end, the tubular needle shield may comprise one or more, preferably two protruding parts in the form of reeds. In the case when there are two protruding reeds, they can be located on opposite sides relative to the longitudinal central axis of the injector. The proximal portion of the tubular needle protective case preferably has a generally cylindrical shape (given the generally cylindrical shape of the drug container). The most proximal part is a completely closed cylinder, from which two protruding tongues protrude, and departs from the proximal end of the tubular needle shield for a certain distance in the direction of the distal end of the injector. In a preferred embodiment, the protruding tabs include three areas. The first, most proximal region is formed by two cylindrical segments having the same radius / diameter as the closed cylindrical, most proximal part of the tubular protective case for the needle. The distal parts or regions of the protruding reeds are spaced apart from each other, which is greater than the diameter of the cylindrical part. An intermediate region is provided between the two regions, which forms a transition between the smaller diameter of the cylindrical region and the greater distance at the distal end of the protruding reeds. Generally speaking, the tubular needle protective case has an expanding configuration as it expands from the proximal end in the direction of its distal end. Such a configuration can also be provided by protruding tongues inclined relative to the longitudinal axis and having only one or two separate regions.

The injector, in accordance with the present invention, may further include means for fixing the container master device configured to rotate with respect to the container body and master device. The specified means of fixing the host device of the container may be provided distally to the tubular protective case for the needle. The means for fixing the container master device is intended to hold the container master device in its initial locked position and to release said container master device from its initial locked position in the direction of the proximal end of the injector to transition to the second position.

Thus, the locking means of the container master device provides a mechanism that prevents the activation of the container master device (locking mechanism), i.e. bringing it into the position of the introduction of the drug dose, before the device is ready for use. Preferably, this functionality is provided by the configuration of the fixation means of the container master and the container master so that actuation of the container master is prevented until the injector touches the injection site.

The means for fixing the container master device may be an element having a generally ring shape. The means for fixing the container master device is preferably proximal to the container master device.

In addition, the means for fixing the container master device is rotatable with respect to the housing and in engagement with the tubular needle protective case.

The tubular needle protective case and the fixing means of the container master are preferably operatively connected, so that the axial movement of the specified tubular protective needle case in the direction of the distal end of the injector causes said container fixing means to rotate. Such rotational movement of the fixation means of the container master device results in the release of said container master device.

Such an operative connection may be provided by one or more groove structures provided on the outer surface of the fixation means of the container master device. Each groove structure preferably has two segments, namely an inclined groove, that is, a groove having an inclination relative to the longitudinal axis of the device, and a longitudinal axial groove, that is, extending parallel to the longitudinal axis of the device. In the initial position of the injector, radial protrusions formed on the inner surface of the protruding tongues are located in an inclined groove of the groove structures. When the injector is placed at the injection site, the tubular protective case for the needle is thereby repelled or displaced towards the distal end of the injector. This displacement of the tubular needle protector causes the protrusions to enter or slide along the inclined groove in the direction of the distal end of the fixation means of the container master. Since the means for fixing the container master device is rotatable relative to the body but fixed longitudinally (in the sense that it abuts the container master device) and the tubular needle protector is rotationally locked, the longitudinal displacement of the tubular needle protector in the direction of the distal end the injector results in a rotational movement of the fixation means of the container master device, which allows the protrusions to slide towards the distal ends x grooves.

The injector further comprises a container driving device that allows connection to the container holder and is engaged by threading to the piston rod. Said container driving device is operatively connected to an energy storage element (which is described in detail below), so that, due to the axial output force from said second energy storage element, the container holder and piston rod can axially move relative to the housing a predetermined distance towards the proximal end the injector from the initial locked position to the second position, as a result of which the needle penetrates.

From the proximal side, the container master device preferably includes at least one shoulder of the container master device. In a more preferred embodiment, two arms of the container master are present. Each of these shoulders of the container master device comprises an engagement hole configured to engage with, for example, corresponding engagement protrusions extending from protruding tabs of the container holder provided from a distal end of the container holder. Thus, the drug container holder is connected to the container driving device, and the longitudinal displacement of the container driving device towards the proximal end of the injector results in the drug container holder moving toward the proximal end of the injector, whereby the needle penetrates.

The container master device may include at least one rotation blocking rib. In a preferred embodiment, more than one, for example, three or four rotation blocking ribs may be provided. In the assembled state of the injector, said rotation blocking ribs are located or fit into the corresponding blocking grooves that are located on the inner surface of the proximal intermediate part of the body. The locking ribs, as well as the corresponding locking grooves, preferably extend in the longitudinal direction. Such a structure prevents rotation of the container master device itself, that is, the container master device is able to move longitudinally relative to the housing, but is rotationally blocked.

According to a preferred embodiment, the container master device includes at least one bar. For example, two slats are provided. These straps, for example, are located in a plane that is perpendicular to the longitudinal axis of the injector so as to form partially ring-shaped supports, so that with the help of these straps, the container lead device initially abuts against the support ribs located on the inner surface of the container driving device fixation means. Thus, the container master device on its proximal side is partially blocked by the container master device lock means. These supporting ribs are located proximally to the straps, so that they form a limiter against the proximal axial movement of the container master device. The supporting ribs may be in the form of corresponding partially annular supporting protrusions. Therefore, in the initial position of the injector, that is, before the start of use, the proximal displacement of the container master device and thus the drug container holder is prevented, since this displacement is blocked by the fixing means of the container master device, due to the planks abut against the supporting ribs. Only during the rotational movement of the means for fixing the master device of the container, the supporting ribs are shifted from the stop position to the bars. Thus, the container master is no longer locked / locked by the fixing means of the container master.

The injector further includes at least one piston rod, the proximal end of which is configured to contact the piston stop of the drug container. The specified piston rod contains a threaded structure, as well as at least one longitudinal groove on its outer surface. From the proximal end, the piston rod may have the tip of the piston rod onto which the auxiliary rotational element is latched. The specified rotational element acts on the piston stroke limiter in the drug container. Using its threaded structure, the piston rod is screwed through the central through hole of the container master device having a corresponding threaded structure.

The drive means of the piston is slidably relative to the piston rod. The drive means of the piston is also blocked from rotation relative to the piston rod and has the ability to rotate relative to the housing. Furthermore, said piston drive means is operatively associated with yet another energy storage element.

The piston driving means preferably includes a piston driving means and a means for fixing the piston driving means. Said means for fixing the drive means of the piston may have a distal part having a generally cylindrical configuration and a proximal part formed by a radial flange of the proximal end. The proximal flange of the means for fixing the drive means of the piston may include at least one blocking rotation element protruding essentially radially. In a preferred embodiment, two or more of these rotation blocking elements are provided. Using the data blocking the rotation of the elements, the fixing means of the drive means of the piston is initially fixed from rotation relative to the host device of the container. In order to provide such a rotational fixation, the container driving device comprises corresponding longitudinal ribs on the inner surface of its distal part. These rotation blocking elements initially abut against these ribs. Thus, the container driving device is at least partially overlapped with the piston driving means fixing means distal to the container driving device. The axial length of these blocking ribs of the container master device is adapted to the length by which the container master device and the drug container holders are offset / are able to be displaced in order to permit needle penetration. In more detail, the axial length of said blocking ribs is such that when the holder of the drug container is completely displaced towards the injection site, the rotation blocking elements are eventually released from engagement with the blocking ribs. This means that at this stage, the locking means of the drive means of the piston is no longer rotationally fixed by the container master. In other words, when needle penetration is performed, the container holder moves longitudinally with respect to the fixation means of the piston drive means. The means for fixing the drive means of the piston is blocked axially. Such axial locking is achieved by means of a locking structure at the distal end of the means for fixing the drive means of the piston, which is engaged with the corresponding structure from the distal end of the distal intermediate part of the housing.

Said piston driving device is rotationally locked to the fixing means of the piston driving means, but has the possibility of sliding in the axial direction relative to the fixing means of the piston driving means. The piston master may include two internal longitudinal ribs. These longitudinal ribs interact with the longitudinal grooves on the outer surface of the piston rod. Thus, the piston rod is rotationally locked to the piston master, but can slide axially along these ribs.

In addition, the piston master may further include a longitudinal section through its wall. Using this longitudinal section, the piston master is connected to the inner end of the energy storage element. Thus, the force that the energy storage element exerts on the piston master is transmitted to the piston rod due to the engagement of the internal longitudinal ribs with the longitudinal grooves.

On the other hand, the piston driving device may include at least one longitudinal rib. For example, four such ribs are provided, spaced 90 ° apart. The outer longitudinal ribs fit slidably into the longitudinal grooves of the means for fixing the drive means of the piston. Thus, as long as the rotation of the locking means of the driving means of the piston is prevented, due to the locking engagement with the container driving device, the rotation of the piston driving device and the piston rod is also prevented, although the force of the first spring acts on the piston driving device. However, as soon as the locking means of the drive means of the piston is released for rotation, the piston driving device and the piston rod also begin to rotate under the influence of the first spring. In the initial state of the injector, that is, before the start of use, the proximal part of the piston rod fits into the Central hole of the container master device. The specified Central hole of the container master device contains a threaded structure that engages with the thread of the piston rod. Thus, the proximal portion of the piston rod having a thread is screwed into the container master. Due to this threaded engagement, rotation of the piston rod when using the injector results in an axial displacement of the piston rod towards the proximal end of the injector. In other words, the piston rod rotates by threaded engagement in the direction of the drug container and causes the stopper in the drug container holder abutting against the rotational element to move towards the proximal end of the drug container holder in order to displace the drug. The torque force of the spring will continue to move the piston rod toward the proximal end of the injector, pressing the stop to force the drug through the needle. The container master device slides along the piston rod as the piston rod continues to move toward the proximal end of the device. The injection ends when the stop reaches the proximal end of the drug container.

Thus, the container master device forms a blocking mechanism that is configured to substantially impede drug delivery when it is in its initial blocking position. Preferably, in the blocking position, said blocking mechanism is capable of substantially inhibiting the movement of at least one piston rod relative to other parts of the device. Preferably, the container driving device (locking mechanism) is configured to substantially impede the movement of the piston rod in the proximal direction in the locking position. More preferably, the locking mechanism is configured to substantially impede the movement of the piston rod in the proximal direction along the longitudinal axis of the device in the locking position.

Preferably, the container master device is configured to permit drug delivery when it is in at least one delivery position, i.e., in a second position. In the second position, after the penetration of the needle is performed, the container master device is preferably capable of permitting drug delivery by injection. Preferably, in the delivery position, the container master device is configured to permit at least some movement of the at least one piston rod in the proximal direction relative to other parts of the device along the longitudinal axis of the device.

The movement of the piston rod in the proximal direction preferably leads to the displacement of at least one drug from at least one container for a drug. The specified drug is preferably in a liquid state, and the specified container for the drug is preferably placed in the holder of the container for the drug.

In addition, in accordance with this invention, the first energy storage element and the second energy storage element are located inside the injector body and are adapted to store and store energy. The specified first energy-accumulating element is used to displace the drug after the needle penetrates and is preferably located at the distal end of the injector, inside the distal part of the body. Said second energy storage element is used to axially displace the drug container holder in order to permit needle penetration before drug administration. Thus, needle penetration and drug delivery are separated because various energy storage elements are used.

The first energy storage element of the injector may comprise a first end attached to the piston drive means and a second end connected to the housing, for example, to the distal portion of the housing. Preferably, the first energy storage member is a spring with a constant stiffness coefficient. For example, the first energy storage element is a flat coil spring.

The second energy storage element may be located between the container master and the bar on the inner surface of the housing. The second energy storage element may be a coil spring or a coil spring located coaxially with the longitudinal axis of the injector. In particular, the distal end of the second energy storage element may be in contact with the inner surface of the distal radial wall of the distal intermediate part of the housing. Alternatively, it may be in contact with a strip provided on the inside of the distal intermediate part of the body proximal to the distal radial wall of the distal intermediate part of the body. The proximal end of the second energy storage element, on the other hand, abuts against the distal surface of the container master.

The injector may further include resilient means for pushing the tubular protective case or needle cover toward the proximal end of the injector when the injector is removed from the injection site. Thus, the tubular needle protective case preferably closes the needle when the injector is removed from the injection site.

The injector may further include locking means to block the tubular needle protector against biasing toward the distal end of the injector when the injector is removed from the injection site. As long as the injector is pressed against the injection site, said protrusions remain from the distal end of the groove structures. However, when the user removes the injector from the injection site, the tubular needle protector is pushed toward the proximal end of the injector. During this movement, the protrusions slide from an inclined groove into a longitudinal groove (which are joined by their distal ends in the form of the letter V) and slide along the longitudinal grooves. The protrusions are then fixed at the proximal ends of the longitudinal grooves using the corresponding blocking structures.

Therefore, the tubular needle shield in accordance with this invention is movable or movable. More preferably, after using the device, the tubular needle protector is displaced and locked in the distal position when the injector is removed from the injection site. The tubular needle protective case is preferably pushed in the proximal direction by the force of at least one spring. Said spring (s) may be provided in the distal region of the tubular needle shield. Thus, the tubular needle protector is a protective element, such as a needle protector or needle guard, which protects the user from inadvertent or accidental contact with the needle, which may be contaminated.

Such a proximal displacement of the needle case can be achieved by means of a spring holder of the proximal part of the body, which may be generally ring-shaped or substantially ring-shaped and arranged coaxially with the proximal part of the body. Said spring holder of the proximal part of the housing may surround the distal region of the drug container holder when viewed radially between the distal region of the drug container holder and the distal regions of protruding tongues. Said spring holder may include one or more pins that support the springs to push the tubular needle case toward the proximal end of the injector when the injector is removed from the injection site after the administration of the drug in order to close the needle .

Thus, the means for fixing the tubular needle protective case are preferably formed by means for fixing the container master. An operative connection between the tubular protective case for the needle and the means for fixing the container master device can be created using a curved groove mechanism.

The injector may further comprise an injection indication mechanism or assembly for displaying the progress of the injection to the user. The signal may be visual or tactile.

Said injection indication mechanism may be a rotary mechanism or an injection indication assembly configured to display the progress of the injection to the user.

The indicated display unit may include a distal indicator cover assembly, which is mounted on the proximal part of the housing, for example, by pressing or snapping-in. Thus, this cap becomes part of the injector body. On a distal surface perpendicular to the longitudinal axis of the injector, the cap may have at least one opening or window. The indicated rotary mechanism for indicating the injection is positioned so that the progress of the injection is demonstrated, for example, through at least one opening provided at least in the distal end surface of the lid.

The rotary mechanism / injection indication unit may include a signal element and a drive mechanism for rotationally actuating said signal element. Thus, the signal element is operatively connected to the drive mechanism.

Said drive mechanism may be coupled to the drive means of the piston. In one embodiment, said drive mechanism is coupled to a distal end of the piston drive means.

The indicated rotary mechanism for indicating the injection is positioned so that the progress of the injection is demonstrated, for example, through at least one hole provided at least in the distal end surface of the housing.

In accordance with one embodiment of the present invention, a drive mechanism of said rotary injection indication mechanism is formed by a planetary gear assembly. The sun gear of said planetary gear assembly is connected to a piston drive means, for example, a piston master.

Said signal element may comprise at least one indication element for informing the user that the device is ready for drug administration, that drug administration is taking place and that drug administration has come to an end.

The specified at least one indication element is preferably provided on the surface of the signal element to which the longitudinal axis of the injector is perpendicular. In a preferred embodiment, said at least one indication element is provided only on the surface of the signal element to which the longitudinal axis of the injector is perpendicular. In an alternative embodiment, the signal element may also have at least one indication element located on the annular, radial surface of the signal element. The specified at least one indication element may be facing towards the distal end of the injector.

The signal element preferably includes a rotatable, preferably circular disk. The specified disk (indicator disk) may be located axially between the planetary gear assembly and the distal wall of the indicator cover. The indicator disc is connected to a planetary gear using an appropriate gear structure. Thus, the rotation of the sun gear turns into a rotation of the disk.

The indicator element or region is distinguishable from the rest of the indicator disk region, for example, by means of a different color or other surface structure. In the initial position of the injector, the indicator assembly is located so that the indicator area is on one side of the window in the lid. This window preferably has a crescent shape. Alternatively, it may be in the form of the letter L. Also, in the alternative, in the case of a sickle shape, from one end of the window, the sides of the window may converge with each other, while the other end may be truncated. Thus, the indicator assembly can be positioned so that the indicator area is initially located on the side of the window that has the largest width. Therefore, the user can see most of the indicator element through the window. During drug administration, the indicator disc rotates, and at the same time, the indicator element rotates in the direction of the other end of the window, that is, in the direction of the smaller / narrower end. Thus, the area of the indicator element visible to the user is reduced, which visually represents the progress of the injection for the user, and also, ultimately, indicates to the user the end of the dose.

During the complete administration of the drug, the indicator disc preferably rotates through an angle, for example, from 90 ° to 180 °, that is, between a quarter and a half of a full revolution.

In an alternative embodiment, the drive mechanism of said rotary injection indication mechanism is formed by a hub coupled to said piston drive means, for example a piston driver. Also in this embodiment, the indicator assembly includes a cover that is attached to the distal portion of the housing. The specified cover, thus, is located distally to the distal part of the housing and, therefore, forms an extension of the housing from its distal end. In particular, this cap forms the distal surface of the injector.

In this embodiment, the signal element is a rotatable, preferably circular element, such as a wheel or a disc.

Said drive mechanism and signal element are preferably manufactured integrally, that is, as a unit. For example, the pivoting member comprises a cylindrical proximal protrusion, such as a wheel hub. By means of this wheel hub, the rotary element is connected and attached to the distal end of the piston driving device.

The specified drive mechanism and the signal element fit in the specified cover.

The signal element may comprise an indication structure for informing the user that the device is ready to administer the drug, that the drug is being administered, and that the drug is nearing completion.

The indicated display structure may include a plurality of segments separated from each other by a plurality of ribs protruding from the surface of the signal element. Alternatively, individual segments can be separated from each other by recesses in the surface of the signal element.

These ribs protrude from the surface of the rotary disk in at least the distal direction and extend radially relative to the radial center of the injector. During rotation of the rotary disk, the alternating structure of the ribs / recesses and segments passes through the said windows. In a preferred embodiment, the segments and / or ribs / recesses include indication elements. For example, the segment or rib that appears in the window in the initial state of the injector contains the first indication element, while the segment or rib that appears in the window at the final stage of the injection probably contains a second, different indication element, so that the user can easily distinguish initial condition before the injection from the final stage after administration of the drug. For example, segments are painted in various colors. Alternatively, the angular width of the segments can vary, for example, from a very small value of the width to a large value in order to distinguish between the initial position and the final position.

As mentioned above, the cover of the display unit may have at least one opening. In this embodiment of the invention, two opposing openings / windows are preferably provided. These two windows are located opposite each other relative to the Central axis of the injector, that is, they are placed diametrically opposed. Through these openings, the user can see the signal element. The specified window (s) is preferably located at the junction between the side surface and the distal end surface of the lid. When the piston master rotates with the first energy-storing element, the rotary element also rotates. The user can observe this through the indicated windows. Therefore, the user can easily see that the device is working properly and that the injection is taking place.

In all embodiments, the pivoting mechanism / injection indication assembly may be distal to said first energy storage element. It can also be located distally to the piston drive means.

The injector in accordance with this invention is particularly useful in the case of highly viscous liquids having a viscosity coefficient of approximately 50 cP. For such fluids, the first energy storage element preferably gives a piston force of 70 N on average (i.e., a lower load force of 60 N and an upper load force of 80 N).

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings disclose an embodiment of the present invention for illustrative purposes only. In particular, the disclosure within the framework of these drawings is not intended to limit the scope of protection of this invention. The illustrated embodiment may be modified in many ways within the scope of the claims.

Figure 1 illustrates a perspective view of an injector, in accordance with a first preferred embodiment of the present invention;

Figure 2 shows a first view of the injector, in accordance with the first preferred embodiment shown in Figure 1, in an exploded view;

Figure 3 shows an additional view of the injector, in accordance with the first preferred embodiment of the present invention, in disassembled form;

Figure 4 shows an additional view of the injector, in accordance with the first preferred embodiment of the present invention, in disassembled form;

Figure 5 illustrates additional components of the injector, in accordance with a preferred embodiment;

6 illustrates additional components of an injector, in accordance with a preferred embodiment;

7 shows a sectional view of an injector, in accordance with a preferred embodiment of the present invention, in the initial position;

Fig. 8 illustrates a perspective view of an injector, in accordance with a preferred embodiment of the present invention, in the starting position, as shown in Fig. 7;

9 illustrates a perspective view of a second preferred embodiment of the present invention;

10 illustrates a perspective view of parts of a second preferred embodiment;

11 illustrates a perspective view of the details of a second preferred embodiment;

12 illustrates a perspective view of the details of a second preferred embodiment;

13 illustrates a perspective view of a third preferred embodiment of the present invention; and

Fig. 14 shows an exploded display device according to a third preferred embodiment.

DETAILED DESCRIPTION OF THE DRAWINGS

Figure 1 illustrates a perspective view of an injector in accordance with a first preferred embodiment of the present invention. The injector 1 has a casing comprising a proximal casing part 2, a distal casing part 3, a proximal intermediate casing part 4 (not shown in FIG. 1), and a distal intermediate casing part 5. In the assembled state of the injector 1, the proximal part 2 of the body, the distal part 3 of the body and the distal intermediate part 5 of the body form the outer surface or the outer side of the injector 1.

As shown in FIG. 1, the proximal part 2 of the casing comprises at least one window 6. In a preferred embodiment, two such windows are provided that are on opposite sides of the proximal part 2 of the casing. Such a window allows the user to see the injection stage, that is, whether the injector 1 is still at the initial stage when the drug is not yet administered, or if the container for the drug is already empty. Through the window 6, the user can see the container for the drug placed at least in the proximal part 2 of the body.

In addition, figure 1 shows the frontal cap 7, which closes the proximal opening of the proximal part 2 of the body before the start of the use of the injector 1.

1, the outer end 41 of the spring can also be seen. This part will be described in more detail below.

Figure 2 shows the first view of the injector 1, in accordance with the first preferred embodiment of the present invention, in disassembled form. In this exploded view shown in FIG. 2, the proximal part 2 of the body, the distal intermediate part 5 of the body and the distal part 3 of the body, as well as the front cap 7 are shown “separately” from the injector 1. In addition, FIG. 2 shows the proximal intermediate part 4 of the body. The specified proximal intermediate part 4 of the body forms part of the body of the injector 1, but is actually located inside it (as can be clearly seen in the sectional view shown in Fig. 7) in order to connect the proximal part 2 of the body and the distal intermediate part 5 of the body with each other . In this regard, the outer surface of the proximal intermediate part 4 of the casing and the inner surfaces of the proximal part 2 of the casing and the distal intermediate part 5 of the casing are respectively provided with corresponding engagement structures, such as ring-shaped groove-rib structures, as shown in FIG. 2. Thus, the proximal casing part 2 and the distal intermediate casing part 5 can easily be snapped onto the proximal intermediate casing part 4, so that the proximal casing part 2 and the distal intermediate casing part 5 are not separated from each other. However, the connection between these parts can be detachable so that the drug container can be inserted inside or removed from the proximal part of the injector 1.

As further depicted in FIG. 2, an injector according to a first embodiment of the present invention includes a medication container holder 10. In the fully assembled state of the injector 1, the holder 10 of the drug container, at least with its proximal part, is inside the proximal part 2 of the body. This will be described in more detail below with reference to FIG. In the preferred embodiment shown in FIG. 2, the drug container holder 10 includes first and second guides 11 of the container holder. Preferably, the guides 11 of the container holder are located on opposite sides of the container holder 10 and extend along its longitudinal direction. The guides 11 of the container holder fit into the corresponding groove structures provided on the inner surface of the proximal part 2 of the body, so that the holder 10 of the drug container is able to move in the axial direction with respect to the body, but is blocked against rotation relative to the body, in particular with respect to the proximal part 2 buildings.

Figure 2 also shows a tubular protective case 17 for the needle, having from its proximal end protruding part 18 of the tubular protective case for the needle. At the distal end, the tubular needle protector 17 comprises two protruding parts 19 in the form of tongues that are located on opposite sides with respect to the longitudinal central axis of the injector 1. The proximal part of the tubular needle protector 17 has a generally cylindrical shape. The most proximal part is a completely closed cylinder, from which two protruding tabs 19 protrude and extend towards the distal end of the injector 1. In the preferred embodiment depicted in the drawings, the protruding tabs 19 mainly include three areas. The first, most proximal region 191 is formed by two cylindrical segments having the same radius / diameter as the closed cylindrical, most proximal part of the tubular protective case 17 for the needle. The distal parts or regions 193 of the protruding tongues 19 are located from each other at a distance that is greater than the diameter of the cylindrical part. An intermediate region 192 is provided between the two regions, which forms a transition between the smaller diameter of the cylindrical region 191 and the greater distance at the distal end 193 of the protruding tongues 19. In general, the tubular needle shield 17 has an expanding configuration as it expands from the proximal end in the direction its distal end.

Figure 2 additionally shows the spring holder 30 of the proximal part of the body, which has a generally annular shape or essentially annular shape and is located coaxially with the proximal part 2 of the body. The spring holder 30 of the proximal part of the body surrounds the distal region of the drug container holder 10, that is, as shown in FIG. 2, radially between the distal region of the drug container holder 10 and the distal regions 193 of protruding tongues 19. As shown in more detail in 4, the spring holder 30 of the proximal part of the housing includes two pins 31 that support the springs (not shown in FIG. 2) in order to push the tubular needle case 17 for alignment of the proximal end of the injector 1, when the injector 1 is removed from the injection site after the introduction of the drug, to close the needle 13.

Figure 2 also shows the means 25 for fixing the host device of the container, which is a generally annular element. The means 25 for fixing the container master device is rotatable with respect to the housing and meshed with the tubular protective case 17 for the needle. This engagement is described in more detail below with reference to FIGS. 3 and 4.

Distal from the means 25 for fixing the master device of the container is the master device 32 of the container. The container master 32 provides connectivity to the container holder 10, which will be described in more detail below.

In addition, FIG. 2 shows a first energy storage element, that is, a first spring 40 that is used to perform an injection, and a second energy storage element, for example a second spring 45, which is used to axially displace the drug container holder 10, with the aim of performing needle penetration before administering the drug.

Finally, FIG. 2 shows an indicator 80 for indicating the end of a dose.

Additional details depicted in FIG. 2, which have not yet been described, will be described in detail below.

Figure 3 shows an additional view of the injector 1, in accordance with a preferred embodiment of the present invention, in disassembled form.

In Fig. 3, the tubular protective case 17 for the needle, the protruding portion 18 of the tubular protective case for the needle and the means 25 for fixing the host device of the container are shown "separately" from the injector assembly. In addition, the proximal intermediate part 4 of the housing and the first spring 40 are depicted as individual components in more detail.

Figure 3 shows in more detail one of the two opposite groove structures 26 of the means 25 for fixing the master device of the container. Each groove structure 26 has two segments, namely an inclined groove 261 and a longitudinal groove 262. In the initial position of the injector 1, the radial protrusions 20 formed on the inner surface of the distal regions 193 of the protruding tongues 19 are located in the inclined groove 261 of the groove structures 26. When placing the injector 1 at the injection site, for example on the skin of the user, the tubular protective case 17 for the needle thereby repels or shifts towards the distal end of the injector 1. Such an offset of the tubular protective case 17 for the needle stagnates wish to set up the projections 20 move in the inclined grooves 261 in the direction of the distal end of the lead locking means 25 of the container device (which is depicted by an arrow within an inclined slot 261 in Figure 3). Since the means 25 for fixing the container master device is rotatable relative to the housing, but is fixed longitudinally (in the sense that it abuts the container master device 32) and the tubular protective case 17 for the needle is rotationally locked, the longitudinal displacement of the tubular protective case 17 for the needle in the direction of the distal end of the injector 1 results in a rotational movement of the means 25 for fixing the container master device, which allows the protrusions 20 to slide towards the distal ends inclined grooves 261.

As long as the injector 1 is pressed against the injection site, that is, while the tubular needle shield 17 is held in its distal position, the protrusions 20 remain from the distal end of the groove structures 26. However, when the user removes the injector 1 from the injection site, for example, after the introduction of the drug, the tubular protective case 17 for the needle is pushed towards the proximal end of the injector 1, as described above. During this movement, the protrusions 20 slide along the longitudinal grooves 262 and are fixed from the proximal ends of the longitudinal grooves 262 using the corresponding locking structures 28. This prevents the tubular needle shield 17 from being moved again towards the distal end of the injector 1.

Figure 3 additionally shows in more detail the holder 10 of the container for the medicinal product and its two guides 11 of the holder of the container. In addition, one of the two pins 31 of the spring holder 30 of the proximal part of the housing, running parallel to the longitudinal axis in the direction of the proximal end of the injector, is shown in full length.

Figure 3 also shows a device 16 for removing a hard case for a needle. The needle case removal device 16 includes an engagement structure from its proximal end, such as an annular rib on its outer surface, which is engaged with a corresponding engagement structure on the inner surface of the front cap 7, for example with a corresponding groove (shown in FIG. 7). Due to such engagement, when removing the front cap 7, the device 16 for removing the hard case for the needle is removed from the container 12 for the drug. In addition, when removing the device 16 for removing the hard case for the needle, the hard case for the needle, consisting of the soft part 14 and the hard part 15 (see Figure 5), is also removed from the container 12 for the drug, because the corresponding engagement structures interlock two parts of the hard case for the needle and the device 16 for removing the hard case for the needle with each other.

Figure 3 also shows in more detail the master device 32 of the container. The container master 32 includes at least one rotation blocking rib 39. In a preferred embodiment, four rotation blocking ribs 39 are provided, three of which are shown in FIG. In the assembled state of the injector 1, the rotation blocking ribs 39 are located or fit into the corresponding blocking grooves 8, which are located on the inner surface of the proximal intermediate part 4 of the body. The blocking ribs as well as the corresponding blocking grooves extend in the longitudinal direction. Such a structure prevents rotation of the container driving device 32, that is, the container driving device 32 is able to move longitudinally relative to the housing, but is rotationally blocked.

From the proximal side, the container driving device 32 includes at least one shoulder 33 of the container driving device. In the preferred embodiment depicted in the drawings, two arms 33 of the container driving device are provided (see FIG. 4). Each of the arms 33 of the container driving device comprises an engagement hole 34 configured to engage with respective engagement protrusions 36 extending from the protruding tongues 35 of the container holder provided from a distal end of the container holder 10. Thus, the drug container holder 10 is connected to the container driving device 32, and the longitudinal displacement of the container driving device 32 towards the proximal end of the injector 1 (using the second spring 45) results in the movement of the drug container holder 10 towards the proximal end injector 1, whereby the penetration of the needle is performed.

Also, as can be seen in FIG. 3, the container master 32 includes at least one bar 37. In a preferred embodiment, two bars 37 are provided (as can be seen in more detail in FIG. 4). Using these slats 37, the container master 32 rests initially against the support ribs 27 located on the inner surface of the container master fixation means 25 (said support ribs 27 are shown in FIG. 6). Thus, in the initial position of the injector, that is, before the start of use, the proximal displacement of the container master device 32 and, therefore, the drug container holder 10 is prevented, since this displacement is blocked by the means for fixing the container master device 25, due to the fact that the strips 37 abut into the supporting ribs 27. Only with the rotational movement of the means 25 for fixing the container master device (caused by the distal displacement of the tubular protective case 17 for the needle) ra 27 are shifted from the stop position to the splines 37. Thus, the host apparatus 32 of the container is not locked / blocked fixing means 25 leading container assembly.

FIG. 3 also shows a piston driving device 50, a piston rod 60, and a piston driving means fixing means 70. These components are described in more detail below.

Finally, as shown in FIG. 3, the first spring 40 includes an outer end 41 that connects the first spring 40 to the housing, that is, the distal portion 3 of the housing, and an inner end 42 that connects the first spring 40 to the piston master 50 . The outer end 41 may, for example, extend through a longitudinal section in the distal part of the housing, so that it can engage with a hook-shaped wall. The first end 41 can then be seen from the outside, as shown in FIG. Alternatively, the first end of the spring 40 engages with the corresponding engagement structure provided on the inner surface of the distal portion 3 of the housing.

In an exploded view of FIG. 4, the injector 1, in accordance with a preferred embodiment of the present invention, is further shown disassembled. In this figure, the spring holder 30 of the proximal part of the housing, the container driving device 32, and the piston drive means fixing means 70 are shown “separately” from the injector assembly. 4, the container master 32 does not cover the distal end of the drug container holder 10. Thus, it is easy to see two protruding tabs 35 of the container holder, each of which has an engagement protrusion 36.

In addition, two opposite arms 33 of the container master 32 are shown. In a preferred embodiment, each arm comprises two sections, the first section extending radially and the second section extending longitudinally towards the proximal end of the injector. Although only two shoulders 33 of the container driving device and only two corresponding protruding tabs 35 of the container holder are illustrated in the preferred embodiment, the present invention also covers other configurations, such as containing only one shoulder-protrusion pair or more shoulder-protrusion pairs, for example three or four. Similarly, the container driving device 32 may have only one rotation blocking rib 39, but the present invention also encompasses container driving devices having two, three, five or six, or even more rotation blocking ribs. In addition, although the container master 32 shown in FIG. 4 contains only two brackets 37 for adjoining the container master bracing means 25, other configurations having only one, three, four or more brackets are also covered by this invention .

Next, FIG. 4 shows means 70 for fixing the drive means of the piston. The piston drive means fixing means 70 has a generally cylindrical configuration (distal portion 71) and has a radial flange 72 at the proximal end. The proximal flange 72 of the piston drive means fixing means 70 includes at least one rotation blocking member 73 protruding creature radially. In the preferred embodiment depicted in the drawings, two such rotation blocking members 73 are provided. Using the rotation blocking members 73, the piston drive means fixation means 70 is initially rotationally fixed to the container drive 32. In order to provide such a rotational fixation, the container driving device 32 comprises corresponding longitudinal ribs 75 on the inner surface of its distal part (shown in FIG. 7). The rotation blocking elements 73 initially abut against these ribs 75. The axial length of the data of the blocking ribs 75 of the container driving device 32 is adapted to the length by which the container driving device 32 and the drug container holders 10 are biased / biased to allow needle penetration. In more detail, the axial length of the blocking ribs 75 is such that when the holder of the drug container 10 is completely displaced towards the injection site, the rotation blocking elements 73 are ultimately released from engagement with the blocking ribs 75. This means that at this stage the fixing means 70 the piston drive means is no longer rotationally fixed by the container master 32. In other words, when performing needle penetration, the container holder 10 moves longitudinally with respect to the means 70 for fixing the drive means of the piston. The means 70 for fixing the drive means of the piston is blocked axially. Such axial locking is provided by the blocking structure 76 from the distal end of the means 70 for fixing the drive means of the piston, which is engaged with the corresponding structure from the distal end of the distal intermediate part 5 of the housing (see Fig. 7).

5 illustrates additional components of an injector 1, in accordance with a preferred embodiment.

As mentioned above, the needle 13 of the drug container 12 is closed by a rigid needle case consisting of a soft part 14 and a hard part 15.

5 further shows a piston driving device 50, which is rotationally fixed to the means for fixing the drive means of the piston 70, but has the possibility of sliding in the axial direction relative to the means 70 for fixing the drive means of the piston. This will be described in more detail in the context of FIG. 6.

The piston rod 60 shown in FIG. 5 comprises a threaded structure 63 as well as at least one longitudinal groove 61. At the proximal end, the piston rod 60 includes a piston rod tip 62 onto which the auxiliary rotary member 65 is latched. Rotational element 65 acts on the piston travel stop in the drug container 12.

Finally, FIG. 5 shows an assembled indicator for indicating the end of a dose, including an indicator 80 and a U-bracket 81 located between the piston rod 60 and the piston master 50. The U-bracket 81 is connected to the piston drive means fixing means 70 so that when the piston rod 60 is proximally extended and does not touch the U-bracket, a force is applied distally to the U-bracket, indicator 80 and indicator rod 82. 5 further illustrates an indicator rod 82, which is also part of the indicator assembly. A spiral spring (not shown in FIG. 5) is coaxial on the indicator rod 82, in which the spiral spring is located inside the piston rod 60. Thus, the indicator rod 82 with a spring fits inside the central axial through hole in the piston rod 60, while the U-bracket 81 with its two legs lies in two opposite longitudinal grooves at an angle of 90 degrees to the two opposite longitudinal grooves 61 of the piston rod 60.

6 illustrates a piston master 50. The piston master 50 includes, in the illustrated embodiment, two inner longitudinal ribs 51. These longitudinal ribs 51 interact with the longitudinal grooves 61 on the outer surface of the piston rod 60. Thus, the piston rod 60 is rotationally fixed to the piston master 50, but can axially slide along these ribs 51.

The piston driver 50 further includes a longitudinal section 55 through its wall. Using this longitudinal section 55, the piston master 50 is connected to the inner end of the first spring 40. Thus, the force that the first spring 40 exerts on the piston master 50 is transmitted to the piston rod 60 by engaging the inner longitudinal ribs 51 with the longitudinal grooves 61 .

On the other hand, the piston driving device 50 includes at least one outer longitudinal rib 52. In the depicted embodiment, four such ribs 90 ° apart are provided. The outer longitudinal ribs 52 are slidably accommodated in the longitudinal grooves 74 of the means 70 for fixing the drive means of the piston. Thus, as long as the rotation of the means for fixing the drive means of the piston 70 is prevented, due to the locking engagement with the container driving device 32, the rotation of the piston driving device 50 and the piston rod 60 is also prevented, although the force of the first spring 40 acts on the piston driving device 50. However, as soon as the means 70 for fixing the driving means of the piston are released for rotation, the piston driving device 50 and the piston rod 60 also begin to rotate under the influence of the first spring 40. In the initial state of the injector 1, that is, before use, the proximal part of the piston rod 60 is located in the central hole of the container master 32. As shown in Fig.6, the specified Central hole of the host device 32 of the container contains a threaded structure 38, which engages with the thread 63 of the rod 60 of the piston. Thus, the proximal portion of the piston rod 60 having a thread is screwed into the container master 32. Due to this threaded engagement, rotation of the piston rod when using the injector results in an axial displacement of the piston rod towards the proximal end of the injector. In other words, the piston rod 60 rotates by threaded engagement in the direction of the drug container 12 and causes the stopper (not shown) in the drug container holder 10 abutting against the rotational element 65 to move toward the proximal end of the drug container holder with the aim drug displacement. The torque force of the spring 40 will continue to move the piston rod towards the proximal end of the injector 1, pressing the stop to expel the drug through the needle 13. The container master 32 slides along the piston rod 60 as the piston rod continues to move toward the proximal end of the device. The administration of the drug is completed when the limiter reaches the proximal end of the drug container.

When the piston rod 60 is fully rotated towards the proximal end of the injector 1, the two legs of the U-bracket 81 are no longer supported by the longitudinal grooves of the piston rod 60. Thus, the radial legs 86 from the proximal ends of the U-bracket can disengage with cuts in the piston master 50. A spiral spring (not shown), coaxial with the indicator rod 82, causes the indicator assembly to move distally until the indicator 80 touches the distal front surface of the distal portion 3 of the housing. This leads to the fact that the distal protrusions of the indicator 80 pass through the hole 83 of the indicator provided in the center of the distal wall of the distal part 3 of the housing. This provides a visual and tactile indication to the user that the dose of the drug has been completely crowded out.

7 shows a sectional view of the injector 1, in accordance with a preferred embodiment of the present invention, in the initial position. In particular, FIG. 7 illustrates the arrangement of the second spring 45 inside the distal intermediate body portion 5. The distal end 46 of the second spring 45 is in contact with the inner surface of the distal radial wall of the distal intermediate part 5 of the housing. Alternatively, it may be in contact with a strip provided on the inside of the distal intermediate portion of the housing proximal to the distal radial wall of the distal intermediate portion 5 of the housing. The proximal end 47 of the second spring 45, on the other hand, abuts against the distal surface of the container master 32.

The same sectional view is depicted in Fig. 8, but in perspective, to illustrate from a different point the different components with respect to each other and their engagement. In addition, in FIG. 8, a relative arrangement of the indicator 80, the U-bracket 81, the indicator rod 82, and the distal indicator hole 83 can be seen. The indicator rod 82 extends substantially inside the central through hole of the piston rod 60. From the distal end of the injector 1, the distal part of the indicator rod 82 extends beyond the distal end of the piston rod 60 and fits into the inner central hole of the indicator 80. The indicator rod 82 comprises an annular flange 84 adjacent to its distal end. When viewed in the axial direction, between the annular flange 84 and the proximal surface of the indicator 80 is an intermediate part of the U-bracket 81. As shown in FIG. 5, this intermediate part of the U-bracket 81 includes a through hole through which the distal part rod 82 indicator. The two legs of the U-bracket 81 extend axially toward the proximal end of the piston rod 60. From their proximal ends, each of the two legs of the U-bracket 81 includes a radial leg 86. These radial legs 86 protrude into the corresponding radial holes in the piston driver 50 (see FIG. 5).

9 illustrates a perspective view of a second preferred embodiment of the present invention. The injector 100 shown in FIG. 9 is substantially identical to injector 1, in accordance with a first preferred embodiment of the present invention. Identical components are identified with identical reference numbers. Hereinafter, only differences between the first and second preferred embodiments will be described in detail.

As shown in FIG. 9, the injector 100 is different from the injector 1 with respect to the indicator assembly, which is provided to indicate the end of the dose. The structure for needle penetration and drug administration shown in FIGS. 2-6 is also present in the injector 100 illustrated in FIGS. 9-12.

The second preferred embodiment shown in FIG. 9 includes an assembly indicator 180 provided at the distal end of the housing. That is, said complete indicator is preferably located distally to the piston drive device 50, 70 and / or distally to the first energy storage element. This indicator assembly contains a cover having at least one hole 181. In the embodiment depicted in the drawings, two opposite holes / windows 181 are provided. These two windows are located opposite each other relative to the central axis of the injector, that is, they are diametrically located the opposite. Through these openings 181, the user can see the signal element in the form of a rotary element, such as a wheel or disk 182, which is also shown in FIG. 10. The specified window (s) is preferably located at the junction between the side surface and the distal end surface of the lid.

As shown in FIG. 11, the pivot disk 182 comprises a cylindrical proximal protrusion 183, such as a wheel hub. Through this wheel hub 183, the rotary disk 182 is connected to the distal end of the piston master 50. Thus, when the piston master 50 is rotated by the first spring 40, the rotary disk 182 also rotates. The user can observe this through windows 181. Therefore, the user can easily see that the device is working properly and that the injection is taking place.

Also, as shown in FIGS. 11 and 12, the rotary disk comprises a distal indication structure having a plurality of segments 184a, ..., 184i, ..., 184n. These segments 184 alternate with radial ribs 185, that is, are separated from each other by radial ribs. These ribs protrude from the surface of the rotary disk in at least the distal direction and extend radially relative to the radial center of the injector. As the rotary disk 182 rotates, an alternating structure of ribs and segments extends through windows 181. In a preferred embodiment, segments 184 and / or ribs 185 include indication elements. For example, segment 184 or rib 185, which appear in the window in the initial state of the injector 100, contain the first indication element, while segment 184 or rib 185, which appear in the window at the final stage of the injection, probably contain a second, different indication element, so that the user can easily distinguish the initial state before the injection begins from the final stage after the administration of the drug. For example, segments 184 are painted in various colors. Alternatively (not shown), the angular width of the segments can vary, for example, from a very small value of the width to a large value in order to distinguish between the starting position and the end position.

13 illustrates a third preferred embodiment of the present invention. The injector 200 shown in FIG. 13 is identical to the injectors 1 and 100, in accordance with the first and second preferred embodiments, except for the indicator assembly provided at the distal end of the injector 200. Thus, the structure for needle penetration and drug administration 2-6 is also present in the injector 200 illustrated in FIGS. 13 and 14.

Injector 200 includes an indicator 280 assembly. On Fig the indicator 280 is assembled in an unassembled form. The indicator 280 assembly includes a distal indicator cover 281 assembly, which is mounted on the proximal part 3 of the housing, for example, by pressing or latching. An opening or window 282 is provided on a distal surface perpendicular to the longitudinal axis of the injector 200.

Inside the indicator cover 281 is a planetary gear assembly 283. The sun gear 284 of said planetary gear is connected to the piston master 50 from its distal end.

In addition, the indicator disk 286 is axially disposed between the planetary gear assembly 283 and the distal wall of the indicator cover 281. The indicator disc is connected to a planetary gear using an appropriate gear structure. Thus, the rotation of the sun gear turns into a rotation of the disk.

The indicator disk 286 includes an indicator area 287. The indicator area 287 is distinguishable from the rest of the indicator disk 286, for example, by means of a different color or other surface structure. In the initial position of the injector 200, the indicator assembly 280 is positioned so that the indicator region 287 is located on one side of the window 282. Generally speaking, the window can have a crescent shape of any type. Alternatively, it may be in the form of the letter L. Also, as an alternative, in the case of a sickle shape, from one end of the window, the sides of the window may converge with each other (such as side 289), while the other end may be truncated (so as side 288). Thus, the indicator 280 assembly may be positioned so that the indicator area 287 is located on the side of the window that has the largest width (side 288). Therefore, the user can see most of the indication element through the window 282. During drug administration, the indicator disc 286 rotates, and at the same time, the indication element 287 rotates towards the other end of the window 282, that is, towards the narrow end 289. Thus, the region of the element 287 indications visible to the user are reduced, which visually represents to the user the progress of the injection, and also indicates to the user the end of the dose.

During the complete administration of the drug, the indicator disc preferably rotates through an angle, for example, from 90 ° to 180 °, that is, between a quarter and a half of a full revolution.

14 also shows an indicator pin 285, which is also engaged with planetary gear assembly 283. Such a pin 285 may be provided in some cases, so that there is an additional signal element on the outer, radial, surface of the distal part 5 of the housing, as shown in Fig.13.

The second and third preferred embodiments comprise a rotary injection indication mechanism 180, 280 for displaying the progress of the injection to the user. These rotary injection indication mechanisms 180, 280 include a signal element and a drive mechanism for rotationally actuating said signal element. These drive mechanisms are connected to the piston master 50 from its distal end. In addition, these rotary injection indication mechanisms are arranged so that the progress of the injection is visible through at least one opening provided at least in the distal end surface of the housing.

While the invention has been illustrated and described in detail using the drawings and the foregoing description, such illustration and description should be construed as explanatory or exemplary and non-limiting. It will be appreciated that changes and modifications may be made by those skilled in the art within the scope of the following claims. In particular, the present invention encompasses further embodiments with any combination of features from the various embodiments described above and below.

Moreover, in the claims, the term “comprising” does not exclude other elements or steps, and indicating the singular of the components does not exclude the presence of these components in the plural. One component can perform the functions of several features set forth in the claims. The terms “essentially”, “about”, “approximately” and the like in connection with a characteristic feature or value, in particular, also define precisely this characteristic feature or given value, respectively. Any reference positions in the claims should not be construed as limiting the scope.

Claims (22)

1. An injector containing
case (2, 3, 4, 5),
a container holder (10) located inside said housing, said container holder (10) being able to accommodate a drug container (12) having a needle (13) attached to one end thereof and a piston stroke limiter sealed to the possibility of sliding inside the specified container (12) for the drug from its other end,
a drive unit including a piston rod (60) and piston drive means (50, 70), which is slidably relative to the piston rod (60), whose rotation relative to the piston rod (60) is blocked and which is rotatable relative to the housing ( 2, 3, 4, 5), wherein said drive unit further comprises a first energy storage element (40), which is located inside the injector body (1, 100, 200) and is adapted to accumulate and store energy, said drive means (50, 70 ) piston operas tively connected to said first energy-storing element (40);
in which the drive means (50, 70) of the piston is released, so that, due to the output torque from said first energy-accumulating element (40), the drive means (50, 70) of the piston is allowed to rotate, and the piston rod (60) is pushed into the direction of the proximal end of the injector (1, 100, 200), whereby the injection is made, and
a rotary mechanism (180, 280) for indicating an injection configured to display the progress of an injection for a user, said rotary mechanism (180, 280) for indicating an injection includes a signal element and a drive mechanism for rotationally driving said signal element, said drive mechanism connected to said piston driving means (50, 70) from the distal end of said piston driving means (50, 70), said rotary injection indication mechanism (180, 280) is positioned such so that the progress of the injection is demonstrated, for example, through at least one opening provided at least in the distal end surface of the housing. 2. The injector according to claim 1, wherein said drive mechanism of said rotary mechanism (280) for indicating an injection is formed by an assembled planetary gear (283), wherein the sun gear of said planetary gear is connected to said piston master (50, 70). 3. The injector according to claim 1 or 2, wherein said signal element (286) contains at least one indication element to inform the user that the device is ready for drug administration, that drug administration is taking place and that drug administration is suitable by the end. 4. The injector according to claim 3, wherein said at least one indication element is provided on the surface of the signal element to which the longitudinal axis of the injector is perpendicular. 5. The injector according to claim 4, in which said at least one indication element faces toward the distal end of the injector. 6. The injector according to claim 1, wherein said signal element (286) comprises a rotatable, preferably circular disk. 7. The injector according to claim 1, wherein said drive mechanism of said rotary mechanism (180) for indicating an injection is formed by a hub (183) connected to said drive means (50, 70) of the piston. 8. The injector according to claim 7, wherein said signal element is a rotatable, preferably circular element (182). 9. An injector according to claim 8, wherein said signal element comprises an indication structure for informing the user that the device is ready for drug administration, that drug administration is taking place, and that drug administration has come to an end. 10. The injector according to claim 9, wherein said indication structure includes a plurality of segments (184a, ..., 184i, ..., 184n) separated from each other by a plurality of ribs (185) protruding from the surface of the signal element. 11. An injector according to any one of claims 7 to 10, wherein said drive mechanism and said signal element are preferably made as a unit. 12. An injector according to claim 1, wherein said rotary mechanism (180, 280) for indicating an injection is located distally to said first energy storage element (40). 13. The injector according to claim 1, wherein said rotary mechanism (180, 280) for indicating an injection is located distally to said piston drive means (50, 70). 14. The injector according to claim 1, additionally containing:
a container driving device (32), which makes it possible to connect to the container holder (10) and engages by means of a thread with a piston rod (60), said container container driving device (32) being operatively connected to said second energy storage element (45), so that , due to the output axial force from the specified second energy-accumulating element (45), the container holder (10) and the piston rod (60) are able to axially move relative to the housing (2, 3, 4, 5) by a predetermined distance of directing the proximal end of the injector (1, 100, 200) from the initial locked position to the second position, as a result of which the needle penetrates. 15. The injector according to 14, in which in the initial locked position the drive means (50, 70) of the piston is blocked against rotation by means of the master device (32) of the container. 16. The injector according to claim 14, wherein the injector (1, 100, 200) further comprises means (25) for fixing the container master device, rotatable with respect to the housing (2, 3, 4, 5) and the master device (32) container. 17. The injector according to clause 16, in which the specified means (25) for fixing the master device of the container is designed to hold the master device (32) of the container in its original locked position and to release the specified master device (32) of the container from its original locked position in the direction of the proximal end of the injector (1, 100, 200) to move to the second position. 18. The injector according to claim 14, wherein said first energy-storing element (40) comprises a first end connected to the piston drive means (50, 70) and a second end attached to the body (2, 3, 4, 5). 19. An injector according to claim 14, wherein said second energy storage element (45) is located in the longitudinal direction between said container driving device (32) and a bar on the inner surface of the housing (2, 3, 4, 5). 20. The injector according to clause 16, wherein said injector (1, 100, 200) further comprises a tubular protective case (17) for the needle, which is slidably located in the proximal part of said body (2, 3) and capable of acting on said means ( 25) fixing the container master device when said tubular protective case (17) for the needle is pressed against the injection site. 21. The injector according to claim 20, in which the specified tubular protective case (17) for the needle and the specified means (25) for fixing the host device of the container are operatively connected, so that the axial movement of the specified tubular protective case (17) for the needle towards the distal end of the injector causes said means (25) for fixing the container master device to rotate. 22. The injector according to claim 21, wherein said rotational movement of said means (25) for fixing the container master device results in the release of said container master device (32).

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