RU2571332C1 - Medical delivery device - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: injection device contains case and container holder, placed in case, drive unit and indication mechanism. Container holder is made with possibility of placing container with medical substance, which has needle, fixed on one of its ends, and plug, placed with possibility of creating compression and sliding inside container with medical substance on its other end. Drive unit contains plunger rod and means for plunger control. Means for plunger control is made with possibility of sliding relative to plunger rod, is rotationally blocked on plunger rod and has possibility of revolution relative to case. Mentioned drive unit additionally contains first unit for energy accumulation, placed in internal space of case of injection device and made with possibility of accumulation and storage of energy. Device for plunger control is functionally connected with said first unit for energy accumulation. Device for plunger control is made with possibility of unlocking in such way that due to output torque from first unit for energy accumulation device for plunger control can be brought into rotation. Plunger rod is forced to move in direction of proximal end of injection device, which results in performing injection. Mechanism of injection indication is made with possibility of indicating course of injection performance to user. Mechanism of injection indication contains tactile signal unit and drive mechanism for control of tactile signal unit, with drive mechanism being connected with device for plunger control on distal end of plunger control device, and injection indication mechanism is placed in such a way that user senses the course of injection realisation.EFFECT: application of invention makes it possible to track realisation of slowly performed injections.13 cl, 14 dwg

Description

FIELD OF TECHNOLOGY

The present invention relates to an injection device that performs several automatic functions, such as automatic penetration, automatic injection, and an automatic safety tool to prevent accidental injection by a needle, in particular to an injection device capable of handling a medicinal substance in the form of a fluid having a high viscosity .

BACKGROUND OF THE INVENTION

The present invention relates to injection devices for injecting a drug substance in the form of a fluid having a high viscosity, which means that such devices require great effort to squeeze the fluid through the needle when injecting the drug substance.

Auto-injectors or pencil-type injectors have been on sale for many years. One of the first auto-injectors was developed for wartime and was activated by pressing the injector to a part of the body. The main goal was to introduce the drug substance as quickly as possible, not particularly caring for the patient and safety issues. In recent years, several medicinal substances have been developed for administration by patients themselves. Thus, depending on the intended use and type of drug, injection devices have also been developed that, to varying degrees, perform automatic functions that facilitate the administration of drugs in a reliable and safe way for patients and even trained personnel, such as doctors and specialists with secondary medical education.

Auto-injection devices with an automatic injection function often contain a body, a spiral-wound pressure spring acting on the plunger rod, which, in turn, acts on the cork inside the drug container to expel the drug through a needle attached to the container. As a rule, one end of the spring often abuts against the inner end surface of the housing, which means that the housing must be designed for spring force. When high viscosity fluids are required to be injected using an autoinjector, great efforts are required to expel the drug substance through a thin needle. Therefore, the spring becomes very large both in terms of the diameter of the spring winding and in relation to the diameter of the wire. The large size of the spring suggests that the device becomes large, while in some applications and for some consumers, such device sizes are unacceptable.

In addition, in particular, when the injection of the drug substance takes a long time, for example, when a high viscosity liquid is introduced and / or a small diameter needle is used, the user of the injection device wants to know whether the injection is continuing or not. In other words, the user who administers the drug on his own should be notified when the injection is completed and the injector can be safely removed from the injection site.

Publication WO 2004/020028 describes an injection device having a closed scale bar. With the introduction of the drug, the required dose is set in the injection device by rotating the rotary knob. This moves the tape of the scale in accordance with the set dose so that when the turn to set the dose is completed, the corresponding dose volume can be read out through the window. However, such a tape of the scale for indicating the dose does not show the progress of the injection.

An injection device having a strip type indicator proposed in WO 2004/020028 is difficult to assemble. In addition, the user can see the movement of the tape in only one direction or at one viewing angle (or in a small range of viewing angles). In addition, it may be difficult for the user to keep track of slowly ongoing injections.

Another means of communication regarding the course of the injection is a tactile agent. WO 2008/083875 discloses a medical delivery device comprising a tactile warning device capable of vibrating the device, for example, during an injection cycle. Vibration is preferably created by an unbalanced link. The tactile alert link of this device is very cumbersome, especially if it needs to be built into a rather small device, despite the fact that space is usually limited. In addition, vibrations of the entire device may be undesirable in some cases and for some patients, which creates a need for a more subtle tactile alert.

SUMMARY OF THE INVENTION

To solve one or more of the above problems, an injection device according to the independent claim 1 is proposed.

Additional aspects, improvements, and variations are disclosed in the dependent claims, in the drawings, and in the description.

As used herein, the term “distal” refers to a direction away from the dose delivery site. The term "distal part / distal end" refers to the part / end of the delivery device or parts / ends of its units located at the farthest distance from the dose delivery site.

Accordingly, the term "proximal" refers to the direction towards the dose delivery site. The term "proximal part / proximal end" refers to the part / end of the delivery device or parts / ends of its units closest to the dose delivery site.

The injection device according to the present invention may comprise a housing, which may be an integral part or several interconnected and fixed parts, for example, the proximal part of the body, the distal part of the body, and possibly intermediate parts of the body.

One of the parts of the housing may preferably comprise a container holder located in said housing, preferably the proximal part of the housing, if the device is equipped with several parts of the housing. The container holder is arranged to place a container with a medicinal substance having a needle fixed at one end thereof, as well as a stopper arranged to seal and slide inside the said container with a medicinal substance at the other end.

The device may further comprise a drive unit comprising a plunger rod configured to impact the plug of the drug container, as well as a plunger control means capable of moving the plunger rod in the proximal direction, thereby moving the plug. The plunger control means can be slidably mounted relative to the plunger rod and can additionally be rotationally locked on the plunger rod, as well as rotated relative to the housing.

The drive unit may further comprise a first energy storage unit located in the interior of the housing of the injection device and configured to store and store energy. The energy storage link may be a spring that can be stretched to provide energy when the plunger control is unlocked. Preferably, the first energy storage unit is a helically wound spring. Said plunger control means is preferably operatively connected to said first energy storage unit.

The plunger control means can preferably be unlocked so that due to the output torque from said first energy storage unit, the plunger control means can be rotated, the plunger rod being forced to move towards the proximal end of the injection device, as a result of which injection .

According to a main aspect of the invention, the device is equipped with an injection indication mechanism configured to indicate to the user the progress of the injection. The injection indication mechanism may preferably comprise a tactile signal element, as well as a drive mechanism for controlling said tactile signal element.

The drive mechanism may be connected to said plunger control means at the distal end of said plunger control means, while the injection indication mechanism may be positioned so that the injection progress is felt by the user that said tactile signal link protrudes from the distal end surface of the housing. The tactile signaling link thus provides information to the user, for example through a finger resting on the distal end of the device, or another part of the user's hand, depending on how the user holds the device during the injection.

According to one preferred solution, said tactile signal element may comprise at least one distally directed protrusion configured to extend through at least one passage located in said end surface of the housing. Thus, the continuation of the protrusion provides reliable information regarding the progress of the injection. Preferably, the injection device can further be configured such that said drive mechanism is a rotary drive mechanism rotationally locked on said drive means, so that rotation of said rotary drive mechanism during injection moves the tactile signal link in the distal direction, thereby indicating an injection progress . Thus, it is possible to use the rotational movement of the drive means, which is transmitted to the rotary drive mechanism, thereby rotationally controlling the tactile signal link.

To transmit rotational motion to the tactile signal unit, said tactile signal unit may be equipped with threaded segments adapted to cooperate with corresponding threaded segments on said rotary drive mechanism to control said tactile signal unit. Threaded engagement creates a natural positive driving force between components.

When providing the required tactile information, various components of the device can be modified and developed to obtain specific characteristics of the signaling link in order to inform the user about the progress of the injection. The pitch of the threaded segments can be adapted to obtain a predetermined displacement speed of the tactile signal link. The length of the protrusions can be changed to obtain a given time mode or tactile sensations indicating the progress of the injection. Similarly, the starting position and / or end position of said tactile signaling element relative to said distal end surface of the device can be adapted to obtain the desired desired characteristics.

For example, the length of the protrusions and / or the position of the signal link relative to the distal end surface can be selected so that they protrude slightly even before the injection, for example, signaling that the device is ready for use. Then the step can be chosen so that the protrusions do not extend too far during the sequence of the injection, but just enough to provide tactile information that the injection is being performed.

On the other hand, the pitch, length and / or position of the signaling link can be chosen so that it protrudes only at the end or in the final part of the injection sequence, thereby indicating the completion of the injection.

In addition to tactile alarms, the device according to the present invention can also be equipped with an audible alarm link. According to one aspect of the invention, said rotary drive mechanism may further comprise an audible alarm unit configured to audibly indicate to the user the progress of the injection, so that the progress of the injection is heard by the user. This element provides an additional source of information that can enhance the overall functionality of the device and its performance. For example, an audible signaling link can act during the entire injection sequence, while a tactile signaling link becomes visible only during the last phase of an injection.

In addition, the signaling link may also provide some tactile information if said audible signaling link comprises at least one flexible link and at least one shock link. Thus, during the rotation of said rotary drive mechanism, said shock element acts on said flexible link so that it quickly strikes the surface, thereby making a sound, and also providing tactile information in the form of vibration.

The device may be equipped with additional signaling links, in particular, said rotary drive mechanism may further comprise a visual signaling link configured to visually indicate the progress of the injection, so that the progress of the injection is shown through at least one opening provided for at least on the distal end surface of the housing. Thus, the user is also provided with visual information regarding the progress of the injection.

Like the previously mentioned signaling links, the visual signaling link may also contain at least one indicator element for notifying the user that the device is ready for injection of a medicinal substance, that an injection of a medicinal substance is being performed, as well as that the injection of the drug has come to an end.

These and other aspects and advantages of the present invention will become apparent from the following detailed description of the invention and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following detailed description of the invention, reference will be made to the accompanying drawings, where:

in FIG. 1 shows a perspective view of an injection device according to a first preferred embodiment of the invention;

in FIG. 2 shows a first exploded view of an injection device according to a first preferred embodiment shown in FIG. one;

in FIG. 3 shows an additional exploded view of an injection device according to a first preferred embodiment of the invention;

in FIG. 4 shows a further exploded view of an injection device according to a first preferred embodiment of the invention;

in FIG. 5 shows additional components of an injection device according to a preferred embodiment;

in FIG. 6 shows additional components of an injection device according to a preferred embodiment;

in FIG. 7 is a cross-sectional view of an injection device according to a preferred embodiment of the invention in its initial position;

in FIG. 8 is a perspective view of an injection device according to a preferred embodiment of the invention in the starting position shown in FIG. 7;

in FIG. 9 is a perspective view of a second preferred embodiment of the invention;

in FIG. 10 is a perspective view of parts of a second preferred embodiment;

in FIG. 11 is a perspective view of parts of a second preferred embodiment;

in FIG. 12 is a perspective view of parts of a second preferred embodiment;

in FIG. 13 is a perspective view of parts of a second preferred embodiment;

in FIG. 14a, 14b show detailed sectional views of the tactile display mechanism of the second preferred embodiment.

DETAILED DESCRIPTION OF THE INVENTION

In FIG. 1 is a perspective view of an injection device according to a first preferred embodiment of the present invention. The injection device 1 has a casing comprising a proximal casing part 2, a distal casing part 3, a proximal intermediate casing part 4 (in FIG. 2), and a distal intermediate casing part 5. When the injection device 1 is assembled, 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 appearance of the injection device 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 located on opposite sides of the proximal part 2 of the casing. Such windows allow the user to observe what phase the injection is on, i.e. Whether the injection device 1 is still at an initial stage when the drug substance is not yet injected, or the container with the drug substance is already empty. Through the window 6, the user can see the container with the medicinal substance located at least in the proximal part 2 of the housing.

In addition, in FIG. 2 shows the front cap 7 covering the proximal opening of the proximal part 2 of the body before using the injection device 1.

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

In FIG. 2 shows a first exploded view of an injection device 1 according to a first preferred embodiment of the present invention. In this exploded view of FIG. 2, the proximal casing part 2, the distal intermediate casing part 5 and the distal casing part 3, as well as the front cap 7 are shown “removed” from the injection device 1. In addition, in FIG. 2 shows the proximal intermediate part 4 of the body. The proximal intermediate part 4 of the body forms part of the body of the injection device 1, however, it is actually located in the inner space (as clearly shown in the sectional view shown in Fig. 7) to connect the proximal part 2 of the body and the distal intermediate part 5 of the body with each other . To this end, respectively, the outer surface of the proximal intermediate body part 4 and the inner surfaces of the proximal body part 2, as well as the distal intermediate body part 5 are equipped with corresponding engaging structures, such as circumferential groove / rib structures shown in FIG. 2. Thus, the proximal casing part 2 and the distal intermediate casing part 5 can easily snap onto the proximal intermediate casing part 4 so that the proximal casing part 2 and the distal intermediate casing part 5 do not fall off from each other. However, the connection between these parts can be detachable so that the container with the drug substance can be inserted or removed from the proximal part of the injection device 1.

As further shown in FIG. 2, an injection device according to a first embodiment of the invention comprises a drug container holder 10. In the fully assembled state of the injection device 1, the holder 10 of the container with the medicinal substance, at least with its proximal part, is located in the proximal part 2 of the body. This will be described in more detail below with reference to FIG. 7. In the preferred embodiment shown in FIG. 2, the drug container holder 10 comprises 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 in its longitudinal direction. The guides 11 of the container holder are placed in the corresponding groove structures provided on the inner surface of the proximal part 2 of the body, so that the holder 10 of the container with the medicinal substance is axially movable relative to the body, but devoid of rotation relative to the body, in particular relative to the proximal part 2 of the body.

In FIG. 2 also shows a needle shield clutch 17, at the proximal end of which there is a protrusion 18 of the needle shield clutch. At its distal end, the needle shield clutch 17 comprises two reed protrusions 19 located on opposite sides with respect to the longitudinal central axis of the injection device 1. The proximal part of the needle shield clutch 17 has a generally cylindrical shape. The most proximal part is a fully enclosed cylinder, from which two reed projections 19 protrude and extend toward the distal end of the injection device 1. In the preferred embodiment shown in the drawings, the reed projections 19 comprise essentially three regions. 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 sleeve 17 of the needle housing. The distal parts or regions 193 of the reed protrusions 19 are spaced apart from each other by a distance exceeding the diameter of the cylindrical part. Between the two regions, an intermediate region 192 is provided that provides a transition between the smaller diameter of the cylindrical region 191 and the larger distance at the distal end 193 of the tongue protrusions 19. Generally speaking, the sleeve 17 of the needle shield has an expanding shape in the sense that it expands from its proximal end towards its distal end.

In FIG. 2 further shows a proximal casing spring holder 30, which is generally annular or substantially annular and is coaxial with respect to the proximal part 2 of the casing. The proximal holder 30 of the body spring covers the distal region of the holder 10 of the container with the medicinal substance, i.e. located as shown in FIG. 2, radially between the distal region of the drug container holder 10 and the distal regions 193 of the reed protrusions 19. As shown in more detail in FIG. 4, the proximal holder 30 of the body spring contains two fingers 31 carrying springs (not shown in FIG. 2) for pushing the needle sleeve 17 toward the proximal end of the injection device 1 when the injection device 1 is removed from the injection site after drug delivery to cover needle 13.

In FIG. 2 also shows a container drive lock means 25, which is a generally annular element. The container drive lock means 25 is capable of pivoting relative to the housing and is engaged with the sleeve 17 of the needle shield. This engagement is described in more detail below with reference to FIG. 3 and 4.

Distal to the container drive lock means 25 is a container drive 32. The drive 32 of the container is made with the possibility of connection with the holder 10 of the container, which will be described in more detail below.

In addition, in FIG. 2 shows the first link for energy storage, i.e. a first spring 40 used for injecting, as well as a second link for storing energy, for example a second spring 45 used to axially move the drug container holder 10 to penetrate the needle before injecting the drug.

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

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

In FIG. 3 shows a further exploded view of an injection device 1 according to a preferred embodiment of the present invention.

In FIG. 3, the needle shield clutch 17, the needle shield clutch 18, and the container drive lock means 25 are shown “removed” from the assembly of the injection device. In addition, the proximal intermediate part 4 of the housing and the first spring 40 are shown as separate components in more detail.

In FIG. 3, one of two opposite groove structures 26 of the container drive lock means 25 is shown in more detail. Each groove structure 26 has two segments, namely an inclined groove 261 and a longitudinal groove 262. In the initial position of the injection device 1, the radial protrusions 20 formed on the inner surface of the distal region 193 of the reed protrusion 19 are located in the inclined groove 261 of the groove structures 26. When the injection the device 1 is placed on the injection site, for example, the skin of the user, the sleeve 17 of the needle shield is thereby pushed or moved towards the distal end of the injection device 1. This displacement of the sleeve 17 of the needle shield This forces the protrusions 20 to move in the inclined grooves 261 in the direction of the distal end of the container drive lock means 25 (as shown by the arrow in the inclined groove 261 in FIG. 3). Since the container drive lock means 25 can rotate relative to the body but is locked in the longitudinal direction (as it abuts against the container drive 32) and the needle shield coupling is rotationally locked, the longitudinal shift of the needle shield coupling 17 towards the distal end of the injection device 1 results in a rotary moving the container drive lock means 25, allowing the protrusions 20 to slide toward the distal ends of the inclined slots 261.

While the injection device is pressed against the injection site, i.e. while the sleeve 17 of the needle shield is held in its distal position, the protrusions 20 are located at the distal end of the groove structures 26. However, when the user removes the injection device 1 from the injection site, for example, after drug delivery, the sleeve 17 of the needle shield is forced to move towards the proximal end of the injection device 1 as described above. During this movement, the protrusions 20 slide along the longitudinal grooves 262 and are blocked at the proximal ends of the longitudinal grooves 262 by the corresponding locking structures 28. This prevents the needle sleeve clutch 17 from moving again towards the distal end of the injection device 1.

In FIG. 3 further shows in more detail the holder 10 of the container with the medicinal substance with its two guides 11 of the container holder. In addition, one of the two fingers 31 of the proximal holder 30 of the housing spring, extending parallel to the longitudinal axis in the direction of the proximal end of the injection device, is shown in its full length.

In FIG. 3 also shows a puller 16 of the rigid needle shield. The puller 16 of the rigid casing of the needle contains at its proximal end an engaging structure, such as a circumferential rib on its outer surface, which is engaged with a corresponding engaging structure on the inner surface of the front cap 7, for example, a corresponding groove (shown in Fig. 7). Due to this engagement, when removing the front cap 7, the puller 16 of the rigid needle shield is removed from the container 12 with the drug substance. In addition, when removing the hard needle cover puller 16, the hard needle cover containing the soft part 14 and the hard part 15 (see FIG. 5) is also removed from the drug container 12 due to the corresponding engaging structures engaging the two parts of the hard cover the needle and the puller 16 of the rigid needle shield with each other.

In FIG. 3 also shows in more detail the drive 32 of the container. The drive 32 of the container contains at least one rib 39 lock rotation. In a preferred embodiment, four pivot locking ribs 39 are provided, three of which are shown in FIG. 3. In the assembled state of the injection device 1, the rotation blocking ribs 39 are located or placed in the corresponding locking grooves 8 located on the inner surface of the proximal intermediate part 4 of the body. The locking ribs, like the corresponding grooves, continue in the longitudinal direction. This design does not allow the container drive 32 to rotate, i.e. the drive 32 of the container has mobility in the longitudinal direction relative to the housing, but rotationally locked.

On its proximal side, the container drive 32 comprises at least one container drive lever 33. In the preferred embodiment shown in the drawings, two container drive levers 33 are located (see FIG. 4). Each of the container drive levers 33 comprises an engaging hole 34 adapted to engage with respective engaging protrusions 36 protruding from the reed protrusions 35 of the container holder provided at the distal end of the container holder 10. Thus, the container 10 of the container with the drug substance is connected to the drive 32 of the container, while the longitudinal displacement of the drive 32 of the container towards the proximal end of the injection device 1 (using the second spring 45) leads to the movement of the holder 10 of the container with the drug substance in the direction of the proximal end of the injection device 1, whereby penetration with a needle is performed.

In FIG. 3, it can also be seen that the container drive 32 comprises 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 drive 32 initially abuts against the locking ribs 27 located on the inner surface of the container drive locking means 25 (the locking ribs 27 are shown in FIG. 6). Thus, in the initial position of the injection device, i.e. Before its use, the container drive 32, and hence the container 10 of the container with the medicinal substance, are unable to move proximally, since such movement is blocked by the container drive blocking means 25 due to the stop of the bar 37 against the locking ribs 27. Only when the container drive blocking means 25 is rotated ( caused by the distal displacement of the sleeve 17 of the needle shield) the locking ribs 27 stop abutting against the bars 37. Thus, the drive of the container is no longer axially locked / locked 25 stvom container lock actuator.

In FIG. 3 also shows a plunger drive 50, a plunger rod 60, and a plunger displacement blocking means 70. These components are described in more detail below.

Finally, as shown in FIG. 3, the first spring 40 comprises an outer end 41 connecting the first spring 40 to the housing, i.e. with the distal part 3 of the housing, as well as the inner end 42 connecting the first spring 40 to the actuator 50 of the plunger. The outer end 41, for example, can extend through a longitudinal slot in the distal part of the housing so that it can engage with the wall in the form of a hook. The first end 41 in this case can be seen from the outside, as shown in FIG. 1. Alternatively, the first end of the spring 40 is engaged with a mating engaging structure provided on the inner surface of the distal portion 3 of the housing.

In the exploded view shown in FIG. 4, the injection device 1 according to a preferred embodiment of the invention is further shown disassembled. In this drawing, the proximal holder 30 of the housing spring, the drive 32 of the container and the means 70 for blocking the movement of the plunger are shown “removed” from the assembly. In FIG. 4, the distal end of the drug container holder 10 is shown by an uncovered container drive 32. Thus, it is easy to see the tongue protrusions 35 of the container holder, each of which has an engaging protrusion 36.

In addition, two opposing arms 33 of the container drive 32 are shown. In a preferred embodiment, each arm comprises two sections, with the first section extending radially and the second section extending longitudinally to the proximal end of the injection device. Although in the preferred embodiment only two container drive levers 33 and only two corresponding reed protrusions 35 of the container holder are shown, the invention encompasses other configurations, for example only one lever-protrusion pair or a larger number of lever-protrusion pairs, for example three or four. Similarly, a container drive 32 may have only one rotation lock rib, however, the invention also encompasses container drives having two, three, five, or six, or even more rotation lock ribs. Furthermore, although the container drive 32 shown in FIG. 4, contains only two brackets 37 for engaging with a means 25 for locking the drive of the container, other configurations in which there are only one, three, four or more brackets are also included in the scope of the invention.

In FIG. 4 further shows the means 70 for blocking the movement of the plunger. The plunger displacement blocking means 70 is generally cylindrical (distal portion 71) and has a radial flange 72 at its proximal end. The proximal flange 72 of the plunger displacement blocking means 70 comprises at least one rotation locking element 73 that protrudes substantially radially. In the embodiment shown in the drawings, two such locking elements 73 are provided. Thanks to these rotation locking elements 73, the plunger movement locking means 70 is initially rotationally locked on the container drive 32. To ensure such a rotation lock, the container drive 32 contains 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 these locking ribs 75 of the container drive 32 is adapted to the length of the container drive 32, while the drug container holders 10 are biased / biased to penetrate the needle. In more detail, the axial length of the locking ribs 75 is such that when the container holder with the drug is completely displaced towards the injection site, the rotation blocking elements 73 ultimately disengage from the locking ribs 75. This means that at this stage the means 70 blocking the movement of the plunger is no longer rotationally blocked by the drive 32 of the container. In other words, when performing needle penetration, the container holder 32 moves longitudinally with respect to the plunger displacement blocking means 70. The plunger displacement locking means 70 is axially locked. Such axial locking is provided by the locking structure 76 at the distal end of the plunger displacement locking means 70, which is meshed with the corresponding structure at the distal end of the distal intermediate part 5 of the housing (see FIG. 7).

In FIG. 5 shows additional components of an injection device 1 according to a preferred embodiment.

As mentioned above, the needle 13 of the container 12 with the medicinal substance is covered with a rigid casing of the needle, consisting of a soft part 14 and a hard part 15.

In FIG. 5 further shows a plunger actuator 50, which is rotationally locked on the plunger displacement blocking means 70 but configured to axially slide relative to the plunger displacement blocking means 70. This will be shown in more detail in the context of the description of FIG. 6.

The plunger rod 60 shown in FIG. 5, contains a threaded structure 63, as well as at least one longitudinal groove 61. At the proximal end of the plunger rod 60 contains the tip of the plunger rod 62, on which the rotational element 65 is latched. The rotational element 65 acts on the stopper in the drug container 12 .

Finally, in FIG. 5 shows an indicator assembly for indicating a dose end that includes an indicator 80 as well as a U-bracket 81 located between the plunger rod 60 and the plunger drive 50. The U-shaped bracket 81 is connected to the plunger displacement blocking means 70 so that when the plunger rod 60 is proximally advanced and not in contact with the U-shaped bracket, the U-shaped bracket, indicator 80, and indicator rod 82 are forced to move distally. In FIG. 5 also shows an indicator rod 82, which is also part of the indicator assembly. A spiral spring is coaxially located on the indicator rod 82 (not shown in FIG. 5), while the spiral spring is located in the piston rod 60. Thus, the indicator rod 82 together with the spring is placed in the central axial bore in the plunger rod 60, while the two legs of the U-shaped bracket 81 lie in two opposite longitudinal grooves located at an angle of 90 degrees to two opposite longitudinal grooves 61 of the rod 60 of the plunger .

In FIG. 6 shows a plunger drive 50. The plunger drive 50 in the embodiment shown comprises two inner longitudinal ribs 51. These longitudinal ribs 51 interact with the longitudinal grooves 61 on the outer surface of the plunger rod 60. Thus, the plunger rod 60 is rotationally locked on the plunger drive 50, but can axially slide along these ribs 51.

The actuator 50 of the plunger further comprises a longitudinal slot 55 in its wall. Using this longitudinal slot 55, the plunger drive 50 is connected to the inner end of the first spring 40. Thus, the force exerted on the plunger drive 50 by the first spring 40 is transmitted to the plunger rod 60 by engaging the inner longitudinal ribs 51 in the longitudinal grooves 61.

On the other hand, the plunger drive 50 comprises at least one outer longitudinal rib 52. In the present embodiment, four such ribs are provided 90 ° apart. The outer longitudinal ribs 52 are slidably inserted into the longitudinal grooves 74 of the plunger displacement blocking means 70. Thus, while the plunger displacement locking means 70 cannot rotate due to the locking engagement with the container drive 32, the plunger drive 50 and the plunger rod 60 are not rotatable, although the force of the first spring 40 acts on the plunger drive 50. However, after the plunger displacement locking means 70 gains freedom of rotation, the plunger drive 50 and the plunger rod 60 also begin to rotate due to the first spring 40. In the initial period of operation of the injection device 1, i.e. before its use, the proximal part of the plunger rod 60 is located in the central hole of the container drive 32. As shown in FIG. 6, the central opening of the container drive 32 comprises a threaded structure 38 engaged with a thread 63 of the plunger rod 60. Thus, the threaded proximal section of the plunger rod 60 has a screw thread in the interior of the container drive 32. Due to this threaded engagement, the rotation of the plunger rod when using the injection device results in an axial displacement of the plunger rod towards the proximal end of the injection device. In other words, the plunger rod 60 rotates by threaded engagement in the direction of the drug container 12 and causes the plug (not shown) in the drug container holder 12, which is positioned against the rotational element 65, to move toward the proximal end of the drug container holder substance to remove the drug substance. The torque force of the spring 40 continues to move the plunger rod toward the proximal end of the injection device 1, pressing the plug to expel the drug through the needle 13. The container drive 32 slides along the plunger rod 60 as the plunger rod continues to move toward the proximal end of the device. The injection ends when the plug is at the proximal end of the drug container.

When the plunger rod 60 has moved completely in the direction of the proximal end of the injection device 1, the two legs of the U-bracket 81 are no longer supported by the longitudinal grooves of the plunger rod 60. Thus, the radial legs 86 at the proximal ends of the U-bracket can disengage from slots in the actuator 50 of the plunger. A helical spring (not shown) located coaxially with respect to the indicator rod 82 causes the indicator assembly to move distally until the indicator 80 makes contact with the distal front surface of the distal portion 3 of the housing. This leads to the fact that the distal protrusion of the indicator 80 protrudes through the hole 83 of the indicator formed in the center of the distal wall of the distal part 3 of the housing. This visually and tactfully indicates to the user that the dose is fully withdrawn.

In FIG. 7 is a cross-sectional view of an injection device 1 according to a preferred embodiment of the present invention in a starting position. In particular, in FIG. 7 shows how the second spring 45 is located in the interior of the distal intermediate part 5 of the housing. 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 inner side 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 drive 32 of the container.

The same sectional view is shown in FIG. 8, however, as a perspective view, in order to provide a different view of the various components relative to each other, as well as their engagement with each other. In addition, in FIG. 8, the relative position of the indicator 80, the U-bracket 81, the indicator rod 82 and the distal injector opening 83 can be seen. The indicator rod 82 extends substantially in the bore of the plunger rod 60. At the distal end of the injection device 1, the distal portion of the injector rod 82 extends beyond the distal end of the plunger rod 60 and is located in the inner bore 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 portion of the U-bracket 81 comprises a through hole through which the distal portion of the indicator rod 82 extends. The two legs of the U-bracket 81 extend axially toward the proximal end of the plunger rod 60. At their proximal end, each of the two legs of the U-bracket 81 comprises a radial leg 86. These radial legs 86 protrude into the corresponding radial holes in the actuator 50 of the plunger (see FIG. 5).

In FIG. 9 is a perspective view of a second preferred embodiment of the present invention. The injection device 100 shown in FIG. 9 is substantially similar to the injection device 1 according to the first preferred embodiment of the present invention. Identical components have the same reference numbers. Hereinafter, only differences between the first and second preferred embodiments will be explained in detail.

As shown in FIG. 9, the injection device 100 is different from the injection device 1 in terms of an indicator assembly that is configured to indicate the end of a dose. The structure for needle penetration and drug injection shown in FIG. 2-6 is also present in the injection device 100 shown in FIG. 9-12.

The second preferred embodiment shown in FIG. 9, comprises an indicator assembly 180 mounted at a distal end of the housing. In other words, the indicator assembly is preferably located distally relative to the means 50, 70 for controlling the plunger and / or distally relative to the first link for energy storage. The indicator assembly includes a cap 180, which in the present embodiment is transparent and has at least one hole 181 in which the integral panels 184 are placed. In the embodiment shown in the drawings, four opposite holes 181 are provided. Four holes 181 are opposite relative to the central axis of the injection device, i.e. are located diametrically opposite. Through the transparent cap 180, the user can see the signal element in the form of a rotatable element, such as a wheel or disk 182, which is also shown in FIG. 10.

As shown in FIG. 11, the pivot disk 182 comprises a cylindrical proximal protrusion 188, such as a wheel hub. By means of this wheel hub 188, the rotary disk 182 is connected to the distal end of the plunger drive 50. Thus, when the plunger drive 50 is rotated by the first spring 40, the rotary disk 182 also rotates. The user can see this through the cap 180. Thus, the user can easily verify that the device is working properly and that the injection is in progress.

As further shown in FIG. 12, the rotary disk 182 comprises a distal indicator structure having a plurality of segments 190a, ..., 190i, ..., 190n. These segments 190 alternate with radial ribs 192, i.e. separated by radial ribs. The ribs 192 protrude from the surface of the turntable at least in the distal direction and extend radially relative to the central axis of the injection device. When the rotary disk 182 rotates, the structure of alternating ribs and segments is visible through the cap 180 as the panels 184. In a preferred embodiment, the segments 190 and / or ribs 192 form visual signaling links 190, 192. For example, segment 190 or rib 192 shown through cap 180 at the initial stage of operation of injection device 100 contains a first indicator element, while segment 190 or rib 192 shown through cap at end stage of injection probably contains a second, different indicator element, so that the user can easily distinguish the initial stage before the injection from the final stage after the injection of the drug substance. For example, segments 190 are painted in different colors. Alternatively (not shown in the drawings), the angular width of the segments can vary, for example, from a very small width to a large width, in order to distinguish the starting position from the end position.

In addition, these rotary injection indication mechanisms are arranged such that the progress of the injection is shown through at least one opening provided at least on the distal end surface of the housing.

An additional mechanism for providing information available to the user is the sound signaling link. It contains protrusions or strips 194, see FIG. 11, on the proximal directional surface of the rotary disk 182. As can be seen in FIG. 11, the strips are directed generally in a radial direction, but can be arranged in other directions. These straps 194 are adapted to interact with flexible links 196 located on the distally directed end surface 198 of the distal portion 3 of the housing, as shown in FIG. 12. The flexible links 196 comprise at least one (two in the illustrated embodiment) lever 200 extending generally in the same plane as the surface 198, with the free ends having distally inclined surfaces 202 forming wedge-shaped distal directed protrusions.

Thus, when the rotary disk 182 rotates during the injection process, as described above, the strips 194 on the rotary disk 182 come into contact with the inclined surfaces of the protrusions 202 of the levers 200, thereby pressing the levers 200 in the proximal direction until the protrusions 202 come out of contact with straps 194. This leads to the fact that the levers 200 quickly bend back, so that the protrusions 202 of the levers 200 collide with the proximal directional surface of the rotary disk 180, generating an audible sound. Thus, during the rotation of the rotary disk 182, the straps 194 and levers 200 with their protrusions generate sounds that are heard by listening during the injection sequence until the rotary disk stops at the end of the injection sequence.

To provide the user with additional information during the injection sequence, a tactile alert link is located at the distal end of the device. It contains a tactile signaling link 204, see FIG. 11, having a generally tubular shape. On its inner surface, it is equipped with longitudinally directed strips 206 (two in the embodiment shown) located diametrically on opposite sides. These slats 206 are configured to be embedded in longitudinally extending grooves 208 in a central hub or support 210 mounted on the inner surface of cap 180 and directed in the proximal direction, as shown in FIG. 13.

In addition, the actuator 204 is equipped with at least one distally extending protrusion 212 mounted on its distally directed end surface. In the illustrated embodiment, there are two projections 212 on the actuator 204. In addition, the cap 180 is equipped with an appropriate number of passages 214, see FIG. 13 through its end surface located on the side of the support 210 of the cap 180. The length of the protrusions 212 of the actuator 204 is such that they protrude through the passages 214 of the cap 180 for some distance beyond the distally directed end surface of the cap 180 when the actuator 204 is in its extreme distal position along the support 210 of the cap 180. The diameter of the support 210 of the cap 180 is slightly smaller than the inner diameter of the actuator 204, so that the drive is rotationally locked on the sleeve, but can slide along the sleeve, as explained below.

The outer surface of the drive is equipped with threaded segments 216, for example, in the likeness of protrusions extending in a spiral. They interact with corresponding threads or spiral grooves 218, see FIG. 12, in the central passage of the proximal protrusion 188 of the rotary disk 182.

During the injection sequence, the rotary disk rotates continuously, as described above. On the other hand, the tactile signal link is rotationally blocked due to the fact that the longitudinal bars 206 are integrated in the grooves 208 of the cap 180, which, in turn, is fixedly mounted relative to the distal part 3 of the housing. The rotation of the rotary disk 182 thus causes its threaded segments 218 to act on the threaded segments 216 of the tactile signal element 204, as a result of which the tactile signal element 204 is displaced linearly in the distal direction from the initial position, see FIG. 14a. The linear movement, in turn, causes the distally directed protrusions 212 of the tactile signal link to pass through the passages 214 and protrude beyond the surface of the cap 180, see FIG. 14b. Thus, if the patient or user holds the finger close to the distally directed end surface of the cap 180 during the injection sequence, he will feel the protrusions 212 rising from the surface.

Thus, obtaining certain tactile sensations, and therefore reliable information about the progress of the injection, is achieved. In this regard, it should be understood that the length of the protrusions, as well as the initial position of the drive relative to the rotary disk and the thread pitch of the threaded segments, can be varied in various ways to obtain the desired desired end result. For example, the protrusions may be located directly below the distal surface of the cap at the beginning of the injection sequence, so that the protrusions will provide tactile information from the very beginning of the injection sequence. On the other hand, the configuration may be such that the protrusions pass through the distal surface of the cap only at the very end of the injection sequence when the tactile signal link has reached its final position, providing tactile information about the end of the injection sequence, i.e. that the device can be guaranteed to be removed. In addition, the thread pitch of segments 216, 218 can be adapted to obtain a predetermined displacement speed of the tactile signal link during the injection process. It should also be understood that tactile information, as well as audio information and visual information can be used and provided to the user at the same time when handling the device.

While the invention is illustrated and described in detail in the drawings and in the foregoing description, such drawings and description are to be regarded as illustrative or exemplary, but not limiting. It should be understood that secondary specialists can make changes and modifications to the extent of claims 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.

In addition, in the claims, the term “comprising” does not exclude the presence of other elements or steps, and the indefinite article “a” or “an” does not exclude the plural. A single unit can fulfill the functions of several elements listed in the claims. The terms “substantially”, “about”, “approximately” and the like, used in connection with a property or quantity, in particular, also define precisely this property and precisely this quantity, respectively. None of the reference positions in the claims should be construed as limiting the scope of its claims.

It should be understood that the embodiment described above and shown in the drawings should be considered only as a non-limiting example of the invention, and various changes may be made to the scope of the claims.

Claims (13)

1. An injection device containing
- housing (2, 3, 4, 5),
- a container holder (10) located in the said housing, wherein said container holder (10) is arranged to accommodate a drug container (12) having a needle (13) fixed at one end thereof and a stopper arranged to create a seal and slide inside the said container (12) with a medicinal substance at its other end,
- a drive unit comprising a plunger rod (60) and plunger control means (50, 70), wherein the plunger control means (50, 70) is slidable relative to the plunger rod (60), is rotationally locked on the plunger rod (60) and has the ability to rotate relative to the housing (2, 3, 4, 5), while said drive unit further comprises a first link (40) for energy storage located in the inner space of the housing of the injection device (1, 100, 200) and configured to accumulate and conservation energy, wherein said means (50, 70) control plunger operatively associated with said first link for a power storage (40);
- while the means (50, 70) for controlling the plunger is unlocked, so that due to the output torque from the first link (40) for energy storage, the means (50, 70) for controlling the plunger can be rotated, while the rod (60 ) the plunger is forced to move towards the proximal end of the injection device (1, 100, 200), resulting in an injection, and
- an injection indication mechanism (182, 204, 212), configured to indicate to the user the progress of the injection,
characterized in that
the injection indication mechanism (182, 204, 212) comprises a tactile signal link (204, 212) and a drive mechanism (182) for controlling said tactile signal link, wherein said drive mechanism (182) is connected to said control means (50, 70) a plunger at the distal end of said plunger control means (50, 70), wherein said injection indication mechanism (182, 204, 212) is positioned so that the user senses the progress of the injection. 2. An injection device according to claim 1, wherein said tactile signaling link (204) comprises at least one distally directed protrusion (212) configured to extend through at least one passage located in said end surface corps. 3. An injection device according to claim 1 or 2, wherein said drive mechanism (182) is a rotary drive mechanism (182) rotationally locked on said drive means (50, 70) so that the rotation of said rotary drive mechanism (182) during the injection, it moves the tactile signaling link (204) in the distal direction, thereby indicating the progress of the injection. 4. An injection device according to claim 3, wherein said tactile signal unit (204) is equipped with threaded segments (216) configured to cooperate with corresponding threaded segments (218) on said rotary drive mechanism (182) for controlling said tactile signal unit (204). 5. An injection device according to claim 4, wherein the thread pitch of said threaded segments (216, 218) is adapted to obtain a predetermined displacement speed of the tactile signal unit. 6. An injection device according to claim 4, wherein the length of said at least one protrusion (212) is adapted to obtain a predetermined time mode and tactile sensations indicative of the progress of the injection. 7. The injection device according to claim 4, in which the initial and / or final position of said tactile signaling element relative to said distal end surface of the device is adapted to obtain desired characteristics with respect to the course of the injection. 8. The injection device according to claim 3, wherein said rotary drive mechanism (182) further comprises an audible alarm link (194, 200, 202) configured to soundly indicate to the user the progress of the injection, so that the progress of the injection is heard by the user . 9. The injection device according to claim 8, wherein said sound signaling link comprises at least one flexible link (200, 202) and at least one shock link (194), while rotating said rotary drive the mechanism of said impact unit acts on said flexible component so that it quickly strikes the surface, thereby making a sound. 10. An injection device according to claim 9, wherein said flexible link comprises at least one lever (200) located substantially flush with a distally directed surface of the distal body (3), wherein the lever comprises a free end having a distally inclined surface forming a wedge-shaped distally directed protrusion (202), wherein said at least one impact member comprises at least one protrusion or bar (194) on said rotary drive mechanism configured to fit I and contacting it with the output of said distally directed projection of said at least one arm during rotation and thus in the process of injection. 11. The injection device according to claim 3, wherein said rotary drive mechanism further comprises a visual signaling link (190, 192) configured to visually indicate to the user the progress of the injection, so that the progress of the injection is shown through at least one hole provided at least on the distal end surface of the housing. 12. The injection device according to claim 11, wherein said visual signaling unit (190, 192) comprises at least one indicator element for notifying the user that the device is ready for an injection of a drug substance and that an injection of a drug substance is being performed, and also that the injection of the drug has come to an end. 13. An injection device according to claim 12, wherein said visual signaling link is a rotary disk (182).

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