injection device

专利摘要:
injection device. the invention relates to an injection device comprising a housing, a container support arranged in the housing, the container support being configured to accommodate a medicine container having a needle attached to one end of it and a cap sealingly and slidably disposed on the medicine container at the other end thereof, a drive unit comprising a piston rod and piston drive means, the piston drive means being slidably arranged in relation to the piston rod, being rotationally locked to the piston rod and being rotatable with respect to the housing, the drive unit further comprising a first energy-accumulating element arranged within the housing of the injection device and adapted to accumulate and store energy, in which the piston-driving means is operatively associated with the first accumulating energy element, in which the piston actuating means it is releasable in such a way that due to an output torque from the first element of accumulating energy, the piston actuating means are allowed to be rotated and the piston rod is induced towards the near end of the injection device so that a injection is performed and a rotary injection indication mechanism configured to indicate the injection progress to the user, in which the rotary injection indication mechanism comprises a signaling element and a drive mechanism for rotationally driving the signaling element , the signaling element being coupled to the drive mechanism, the drive mechanism being coupled to the plunger drive means at the distal end of the plunger drive means, the rotary injection indication mechanism being arranged in such a way that the progress of injection is shown through at least one opening provided at least on a distal end surface of the accommodation.
公开号:BR112013032570B1
申请号:R112013032570-4
申请日:2012-06-07
公开日:2021-02-23
发明作者:Anders Karlsson；Stephan Olson
申请人:Shl Medical Ag；
IPC主号:

专利说明:

Field of the Invention
[0001] The present invention relates to an injection device having several automatic functions such as automatic penetration, automatic injection and automatic safety means to prevent accidental needle sticks and in particular an injection device capable of handling medication in fluid form having high viscosity . Background of the Invention
[0002] The present invention relates to injection devices for injecting medication in fluid form having high viscosity which means that these devices require high forces to press the fluid through a needle when injecting the medication.
[0003] Auto injectors or pen injectors have been on the market for many years. One of the first auto-injectors was developed for wartime, which was activated by pressing the injector against a body part to activate it. The main concern was to have the medication injected as quickly as possible, without much concern in relation to the patient or in relation to safety aspects of handling. During recent years, some drugs have been developed in such a way that they have to be injected by the patients themselves. Therefore, depending on the intended use and type of medicine, injection devices have also been developed having a varying degree of automatic functions to facilitate the injection of medicines in a safe and reliable way for patients and even for trained personnel, for example, doctors, nurses .
[0004] Self-injecting devices having an automated injection function often comprise a housing, a spirally wound compression spring that acts on a plunger rod, which in turn acts on a lid inside a medicine container to expel the medicine through a needle attached to the container. Normally, one end of the spring is often leaning against an extreme internal surface of the housing, which means that the housing has to be dimensioned for the force of the spring. When fluids with high viscosity are to be injected using an auto-injector, high forces are required to expel the drug through a fine needle. Consequently, the spring becomes very large both in relation to the diameter of the coiled spring and also to the diameter of the wire wire. The size of the spring means that the device becomes large and for some applications and customers, such device sizes are not acceptable.
[0005] Furthermore, in particular, when drug injection takes a long time, for example, when a high viscosity liquid is injected and / or a needle having a small diameter is used, the user of the injection device wants to know if the injection is still going on or not. More specifically, the user self-administering a medication needs to be informed when the injection is finished and whether it is safe to remove the injector from the injection site.
[0006] WO 2010/066592 discloses an injection device comprising a delivery indication mechanism having a flexible strip arranged with different indications. The accommodation has an opening through which the indications are visible. The strip has a first end that is connected to the drive unit of the injection device. When the drive unit is released, the strip will pass through the opening.
[0007] An additional prior art is shown in WO 2004/020028. It describes an injection device having a closed scale range. When administering a product, a required dosage is adjusted in the injection device by turning a rotary knob. This transports the scale range according to the adjustment of a dose, such that after the dosage adjustment rotation is completed, the corresponding dosage unit can be read through a window. Such a scale range for dosage indication does not, however, show the progress of the injection.
[0008] An injection device having a band-type indicator as suggested in WO 2004/020028 is, however, complex to assemble. In addition, the movement of the strip is visible to the user from one direction or viewing angle (or small range of viewing angles) only. In addition, slow injections can be difficult for a user to detect. Summary of the Invention
[0009] To overcome one or more of the problems mentioned above, an injection device according to independent claim 1 is provided.
[0010] Additional aspects, improvements and variations are revealed in the dependent claims, figures and description.
[0011] In this application, when the term “distal” is used, it refers to the direction pointing away from the dose delivery location. When the term "distal end / part" is used, it refers to the part / end of the delivery device, or the parts / ends of the elements thereof, which are / are located further away from the dose delivery site. Correspondingly, when the term “next” is used, it refers to the direction that points to the dose delivery location. When the term "close part / end" is used, it refers to the part / end of the delivery device, or the parts / ends of the elements of the same that are / are located closest to the dose delivery site.
[0012] The injection device of the present invention comprises a housing and a container support disposed within the housing. The container holder is configured to accommodate a medicine container.
[0013] The accommodation may comprise a nearby housing part, a distal housing part, a nearby intermediate housing part and a distal intermediate housing part. In the assembled state of the injection device, the nearby housing part, the distal housing part, and the distal intermediate housing part can form the outer surface or appearance of the injection device. However, the invention also encompasses configurations where the housing comprises a number of additional housing parts or parts. The housing parts may have a generally cylindrical configuration, such as a circular, elliptical, or square or substantially cylindrical configuration.
[0014] A removable front cover can close the opening close to the housing.
[0015] In a preferred embodiment, the nearby intermediate housing part is coaxially located within the nearby housing part and distal intermediate housing part so that it overlaps with the two to form a connection structure to connect these two to each other. The outer surface of the nearby intermediate housing part and the internal surfaces of the nearby housing part and the distal intermediate housing part, respectively, can thus be provided with corresponding latching structures. Such a connection coupling can be provided by circumferential notch rib structures, and can be releasable.
[0016] However, it is also covered by the invention that the nearby housing part and the distal intermediate housing part are connected by other connecting structures without requiring a nearby intermediate housing part.
[0017] The distal intermediate housing part may have a staggered configuration seen in an axial direction such that a part close to it forms part of the external appearance of the injection device, while a distal part of it has an area in section smaller cross-section in relation to the cross-sectional area of the close part so that the end close to the distal housing part can overlap with that part having a smaller cross-sectional area to connect the distal intermediate housing part and the distal housing part between itself. Again, circumferential groove structures can be provided as a connection mechanism.
[0018] However, alternatively, the distal intermediate housing part may not have a staggered configuration, but instead at its distal end the same size in cross section and shape as the distal housing part. In such a case, the distal intermediate housing part and the distal housing part can be connected together, for example, by means of a coaxial sleeve located on the outside or inside of these parts and partially overlapping both.
[0019] The medicine container support is preferably at least with its close part located inside the close housing part. The medicine container support can comprise one or more container support guides. Preferably, the container support guides are longitudinally arranged on opposite external sides of the container support. The container support guides are received in corresponding notch structures provided on the inner surface of the nearby housing part so that the medicine container support is axially movable and manageable with respect to the housing, but is locked from being rotated with respect to the accommodation, in particular in relation to the nearby accommodation part.
[0020] The medicine container is an optional component of the injection device in which it can be inserted into the injection device by the user, for example, by replacing an empty medicine container after using the injection device. In addition, the injection device is not necessarily supplied in its fully assembled state, that is, with the medicine container already accommodated in the injection device after supply of the injection device.
[0021] The medicine container can be a commonly used medicine container having a needle attached to one end of it and a lid disposable sealingly and slidable inside the medicine container at the other end of it.
[0022] In a preferred embodiment of the invention, the housing, for example, the nearby housing part comprises at least one window. This window can extend axially over a certain length of the housing. In an additional preferred embodiment, more than one, for example, two such windows are provided. In the case of two windows, these can be located on opposite sides of the nearby housing part. Such a window allows the user to view the injection status, that is, if the injection device is still in its initial stage with the medication not yet being injected, or if the medication container is already empty. Through the window (s), the user can see the medicine container accommodated at least in the nearby housing part. In addition, in the expelled state, the user can see the plunger rod through the window.
[0023] The injection device may further comprise a needle protection glove or disposable protector slidable in a part close to the housing and being able to act on a container trigger locking means when the needle protection glove is pressed against an injection site. The needle protection sleeve initially covers the needle of the medicine container. In this way, the needle is covered or retracted until the injection device is activated and cannot be unintentionally contacted until that moment. The needle protection glove is movable between a close and a distal position. The needle protection sleeve is preferably contacted and moved when the injection device is positioned at the injection site. On the other hand, the removable front cover in the opening next to the housing prevents the needle protection glove from being accidentally moved before using the device.
[0024] At its distal end, the needle protection sleeve may comprise one or more, preferably two, tongue extensions. In the case of two tongue extensions, these can be arranged on opposite sides, in relation to the longitudinal central geometric axis of the injection device. The part close to the needle protection sleeve is preferably generally cylindrical in shape (assuming a generally cylindrical shape of the medicine container). The nearest part is a fully closed cylinder from which the two tongue extensions protrude, and extends from the near end of the needle guard sleeve for a certain distance towards the distal end of the injection device. In a preferred embodiment, the tongue extensions comprise three areas. A first closest area is formed by two cylinder segments having the same radius / diameter as the nearest cylindrical, closed part of the needle protection sleeve. The distal parts or areas of tongue extensions are spaced apart by a greater distance than the diameter of the cylindrical part. Between these two areas, an intermediate area is provided that forms a transition between the smaller diameter of the cylindrical area and the greater distance at the distal end of the tongue extensions. In general terms, the needle protection glove has an enlargement configuration in which it extends from the near end towards the distal end thereof. Such a configuration can also be provided by tongue extensions being inclined in relation to the longitudinal geometric axis and having a single area or two distinct areas only.
[0025] The injection device of the present invention may further comprise a container actuator locking means which is rotatable with respect to the housing and a container actuator. The container driver locking means can be provided distal from the needle guard sleeve. The container driver locking means is configured to retain the container driver in its initial locked position and to release the container driver from its initial locked position towards the near end of the injection device to the second position.
[0026] In this way, the container actuator locking means provides a mechanism that prevents the container actuator (locking mechanism) from being activated, that is, from being adjusted in a delivery position, before the device is ready to use. Preferably, its functionality is provided by a configuration of the container driver locking means and the container driver in such a way that the actuation of the container driver is prevented before the injection device is in contact with the injection site.
[0027] The container actuator locking means can be a generally ring-shaped element. The container driver locking means is preferably located close to the container driver.
[0028] In addition, the container actuator locking means is rotatable in relation to the housing and in engagement with the needle protection sleeve.
[0029] The needle guard sleeve and the container drive locking means are preferably operationally connected in such a way that axial movement of the needle guard sleeve towards the distal end of the injection device causes the locking means of the container actuator perform a rotational movement. Such rotational movement of the container driver locking means results in a release of the container driver.
[0030] Such an operational connection may be provided by one or more notch structures provided on the outer surface of the container driver locking means. Each notch structure preferably has two segments, namely, an inclined notch, that is, a notch being inclined with respect to the longitudinal axis of the device and an axial longitudinal notch, that is, extending parallel to the longitudinal geometric axis of the device. . In the initial position of the injection device, radial protrusions formed on the inner surface of the tongue extension are located in the inclined notch of the notch structures. When the injection device is placed in an injection site, the needle protection sleeve is thereby pushed or moved towards the distal end of the injection device. Such displacement of the needle guard sleeve causes the protrusions to move or slide along the inclined notch towards the distal end of the container driver locking means. Since the container driver locking means is rotatable with respect to the housing, but longitudinally fixed (where it abuts against the container driver) and the needle protection sleeve is rotationally locked, the longitudinal displacement of the container protection sleeve needle towards the distal end of the injection device results in a rotational movement of the container trigger locking means, allowing protrusions to slide towards the distal ends of inclined notches.
[0031] The injection device further comprises a container actuator which is arranged to be connectable to the container support and threadedly connected to a piston rod. The container actuator is operationally associated with an energy-accumulating element (described in detail below) in such a way that due to an axial output force of the second energy-accumulating element, the container support and the piston rod are axially movable in relative to the housing for a predetermined distance towards the end near the injection device from an initial locked position to a second position through which a needle penetration is performed.
[0032] On its close side, the container driver preferably comprises at least one container driver arm. In a further preferred embodiment, two container driver arms can be present. The container driver arms each comprise a latch opening being configured for latching, for example, with corresponding latch protrusions projecting from the container support tongue extensions provided at the distal end of the container support. In this way, the medicine container holder is connected to the container driver, and the longitudinal displacement of the container driver towards the end near the injection device results in a movement of the medicine holder towards the end near the injection device. whereby a needle penetration is performed.
[0033] The container driver can comprise at least one rotational locking rib. In a preferred embodiment, more than one, such as three or four rotational locking ribs can be provided. In the assembled state of the injection device, the rotational locking ribs are located or received in corresponding locking notches arranged on the inner surface of the nearby intermediate housing part. The locking ribs as well as the corresponding notches extend preferably in the longitudinal direction. Such a structure prevents the container driver from being rotated itself, that is, the container driver is movable in a longitudinal direction in relation to the housing, but rotationally locked.
[0034] According to a preferred embodiment, the container driver comprises at least one shoulder. For example, two shoulders are provided. These bosses, for example, are located on a plane being perpendicular to the longitudinal geometric axis of the injection device to form partial circumferential abutments such that with these bosses, the container driver abuts initially against stop ribs located on the inner surface of the middle container trigger locking system. In this way, the container driver on its close side is partially overlapped by the container driver locking means. The stop ribs are located close to the shoulders so that they form a stop against axial movement close to the container driver. The stop ribs may be in the form of corresponding circumferential stop projections. In this way, in the initial position of the injection device, that is, before its use, the container actuator and thus the medicine container support are prevented from being moved nearby because such movement is blocked by the actuator locking means. container due to the shoulder of the shoulders against the stop ribs. Only after rotational movement of the container driver locking means, the stop ribs are moved out of the abutment with the shoulders. In this way, the container driver is no longer axially locked / blocked by the container driver locking means.
[0035] The injection device further comprises at least one plunger rod being arranged with an end close to the same contactable with the lid of the medicine container. The plunger rod comprises a threaded structure as well as at least one longitudinal notch on its outer surface. At the close end, the plunger rod may comprise a plunger rod end onto which an optional pivoting element is snapped into place. The pivoting element acts on the cap on the medicine container. With its threaded structure, the plunger rod is threaded through a central direct hole in the container driver, having a matched threaded structure.
[0036] A piston drive means is slidably arranged in relation to the piston rod. The piston drive means is also rotationally locked to the piston rod and rotated in relation to the housing. In addition, the piston actuating means is operationally associated with the other element of accumulating energy.
[0037] The piston actuating means preferably comprises a piston actuator and a piston actuating locking means. The plunger actuation locking means can have a distal part of generally cylindrical configuration and a close part being formed by a radial flange with a close end. The flange close to the plunger actuating locking means can comprise at least one rotational locking element which extends essentially radially. In a preferred embodiment, two or more of these lock elements are provided. With these rotational locking elements, the plunger actuation locking means is initially rotationally locked with the container actuator. To provide such a rotational lock, the container driver comprises corresponding longitudinal ribs on the inner surface of its distal part. The rotational lock elements initially touch these ribs. In this way, the container driver at least partially overlaps a plunger driver locking means being located distally to the container driver. The axial length of these container actuator locking ribs is adapted to the length of the container actuator and the medical container supports are displaced / displaced to perform a needle penetration. In more detail, the axial length of the locking ribs is such that after the total displacement of the medication container holder towards the injection site, the rotational locking elements are finally released from the engagement with the locking ribs. This means that at this stage the plunger drive locking means is no longer rotationally locked by the container driver. In other words, when performing needle penetration, the container support is moved longitudinally with respect to the plunger actuation locking means. The piston drive locking means are axially locked. Such an axial lock is provided by a locking structure at the distal end of the piston actuating locking means which is engaged with a corresponding structure at a distal end of the distal intermediate housing part.
[0038] The plunger actuator is rotationally locked to the plunger actuation locking means, but slid in axial direction in relation to the plunger actuation locking means. The plunger driver can comprise two internal longitudinal ribs. These longitudinal ribs interact with longitudinal notches on the outer surface of a piston rod. In this way, the piston rod is rotationally locked to the piston driver, but it can slide axially along these ribs.
[0039] In addition, the plunger driver can also comprise a longitudinal slit through its wall. With this longitudinal slot, the plunger driver is connected to the inner end of the energy-accumulating element. In this way, a force applied to the plunger driver by the element of accumulating energy is transmitted to the plunger rod due to the engagement of internal longitudinal ribs in longitudinal notches.
[0040] On the other hand, the plunger driver can comprise at least one external longitudinal rib. For example, four of these ribs are supplied spaced 90 ° apart. The external longitudinal ribs are slidably received in longitudinal notches of the piston actuating locking means. Thus, as long as the plunger actuating locking means are prevented from being rotated due to the locking engagement with the container actuator, the plunger actuator and plunger rod are prevented from being rotated although the force of the first spring acts over the plunger driver. However, after the plunger drive locking means is free to rotate, the plunger driver and plunger rod also begin to rotate, caused by the first spring. In the initial stage of the injection device, that is, before its use, a part close to the plunger rod is received at the central opening of the container actuator. The central opening of the container driver comprises a threaded structure which engages with the threads of the piston rod. In this way, the next threaded section of the plunger rod is threaded inside the container driver. Due to this threaded engagement, the rotation of the plunger rod after using the injection device results in an axial displacement of the plunger rod towards the end near the injection device. In other words, the plunger rod is rotated by the threaded engagement towards the medicine container, and causes the cap on the medicine container holder and leaning against the pivoting element to move towards the near end of the holder. of medicine container to expel medicine. The spring torque force will continue to drive the plunger rod towards the end near the injection device by pressing on the cap to expel medicine through the needle. The container driver slides along the plunger rod as the plunger rod continues to move towards the near end of the device. The injection is completed when the cap is at the end close to the medicine container.
[0041] In this way, the container actuator forms a locking mechanism that is configured to substantially inhibit the supply of medication when it is in an initial locking position. Preferably, when in a locking position, the locking mechanism is configured to substantially inhibit the movement of at least one plunger rod in relation to other parts of the device. Preferably, the container actuator (locking mechanism) is configured to substantially inhibit the movement of the piston rod in a close direction when it is in a locking position. More preferably, the locking mechanism is configured to substantially inhibit the movement of the plunger rod in a close direction along the longitudinal geometric axis of the device when in a locking position.
[0042] Preferably, the container driver is configured to allow delivery of medication when in at least one supply position, that is, in a second position. When in the second position after needle penetration is performed, the container trigger is preferably configured to allow delivery of medication by injection. Preferably, when in a delivery position, the container driver is configured to allow at least a certain movement of at least one piston rod in a close direction relative to other parts of the device, along the longitudinal geometric axis of the device.
[0043] Moving the plunger rod in the near direction preferably takes at least one medicine to be expelled from at least one medicine container. The medicament is preferably in a liquid state and the medicament container is preferably positioned in the medicament container holder.
[0044] In addition, according to the invention, a first energy-accumulating element and a second energy-accumulating element are arranged within the housing of the injection device and are adapted to accumulate and store energy. The first energy-accumulating element is used to expel the drug after penetration of the needle, and is preferably located at the distal end of the injection device, in the distal housing part. The second energy-accumulating element is used to axially move the medicine container holder to perform a needle penetration prior to the injection of the medicine. In this way, needle penetration and drug delivery are decoupled in which different energy-accumulating elements are used.
[0045] The first energy-accumulating element of the injection device may comprise a first end connected to the piston drive means and a second end connected to the housing, for example, the distal housing part. Preferably, the first element of accumulating energy is a spring of constant force. For example, the first element of accumulating energy is a clock spring.
[0046] The second element of accumulating energy can be arranged between the container actuator and a shoulder on the internal surface of the housing. The second element of accumulating energy can be a helical spring or spiral spring arranged coaxially with the longitudinal geometric axis of the injection device. In particular, the distal end of the second energy-accumulating element may be in contact with the inner surface of a distal radial wall of the distal intermediate housing part. Alternatively, it may be in contact with a shoulder provided within the distal intermediate housing part, close to the distal radial wall of the distal intermediate housing part. The end close to the second energy-accumulating element, on the other hand, touches a distal surface of the container driver.
[0047] The injection device may further comprise a resilient means for inducing the needle protection or protective sleeve towards the end near the injection device when the injection device is removed from the injection site. In this way, the needle protection sleeve preferably covers the needle when the injection device is removed from the injection device.
[0048] The injection device may further comprise a locking means for locking the needle protection sleeve against displacement towards the distal end of the injection device when the injection device is removed from the injection site. While the injection device is pressed into the injection site, the protrusions remain at the distal end of the notch structures. However, when the user removes the injection device from the injection site, the needle protection sleeve is induced towards the end near the injection device. During this movement, the projections slide from the inclined notch into the longitudinal notch (which are connected at their distal ends to form a type of V shape) and slide along the longitudinal notches. The projections are then locked at the ends close to the longitudinal notches by respective locking structures.
[0049] Consequently, the needle protection glove according to the invention is movable or movable. More preferably, after the device has been used, the needle protection sleeve is moved and locked in a distal position when the device is removed from the dose delivery site. The needle protection sleeve is preferably induced in a close direction by the force of at least one spring. The spring (s) can be provided in the distal area of the needle protection sleeve. In this way, the needle protection glove is a protective element, such as a needle protection element or needle protection glove that protects the user against accidentally or accidentally coming into contact with the needle that may be contaminated.
[0050] Such displacement close to the needle sleeve can be provided by a spring retainer of nearby housing that can be generically in the shape of a ring or substantially in the shape of a ring, and coaxially arranged with the housing part nearby. The nearby housing spring retainer can surround a distal area of the medicine container support, seen radially between a distal area of the medicine container support and the distal areas of tongue extensions. The retainer may comprise one or more pins that carry springs to push the needle sleeve towards the end near the injection device when the injection device is removed from the injection site after delivery of the medication has been performed to cover the needle.
[0051] In this way, the needle guard sleeve locking means is preferably formed by the container driver locking means. The operational connection between the needle guard sleeve and the container driver locking means can be formed by a notch-cam mechanism.
[0052] The injection device may further comprise an injection indication assembly or mechanism to indicate the injection progress to the user. The signal can be a visible or tactile signal.
[0053] The injection indication mechanism can be a rotating assembly or injection indication mechanism that is configured to indicate to the user the progress of the injection.
[0054] The indication assembly may comprise a distal indicator assembly cover mounted on the nearby housing part, for example, by means of a pressure or force fitting. In this way, the cap becomes part of the injection device housing. On the distal surface being perpendicular to the longitudinal geometric axis of the injection device, the lid can have at least one opening or window. The rotating injection indication mechanism is arranged in such a way that the progress of injection is shown, for example, through at least one opening provided at least on a distal end surface of the lid.
[0055] The rotary injection indication assembly / mechanism may comprise a signaling element and a drive mechanism for rotationally driving the signaling element. In this way, the signaling element is operationally coupled to the drive mechanism.
[0056] The drive mechanism can be coupled to the piston drive means. In one embodiment, the drive mechanism is coupled to the distal end of the plunger drive means.
[0057] The rotating injection indication mechanism is arranged in such a way that the progress of the injection is shown, for example, through at least one opening provided at least on a distal end surface of the housing.
[0058] According to an embodiment of the invention, the drive mechanism of the rotary injection indication mechanism is formed by a planetary gear assembly. The solar wheel of the planetary gear assembly is coupled to the piston drive means, for example, to the piston driver.
[0059] The signaling element may comprise at least one indication element to inform the user that the device is ready for a medication injection, that the medication injection is in progress and that the medication injection has ended.
[0060] At least one indicating element is preferably provided on a surface of the signaling element to which the longitudinal geometric axis of the injection device is perpendicular. In a preferred embodiment, at least one indicating element is provided only on a surface of the signaling element to which the longitudinal geometric axis of the injection device is perpendicular. In an alternative embodiment, the signaling element may also have at least one indicating element located on a radial, circumferential surface of the signaling element. At least one indicating element may face towards the distal end of the injection device.
[0061] The signaling element preferably comprises a preferably circular, rotating disc. The disk (indicator disk) can be located axially between the planetary gear assembly and the distal wall of an indicator cover. The indicator disc is coupled to the planetary gear by a corresponding tooth structure. In this way, the rotation of the solar wheel is transmitted by gear in a rotation of the disk.
[0062] The indicator element or area is distinguishable from the remaining area of the indicator disc, for example, by means of a different color or a different texture. In the initial position of the injection device, the indicator assembly is arranged in such a way that the indicator area is located on one side of a window in the lid. The window is preferably shaped in a crescent format. Alternatively, it can be shaped like an L. Alternatively, in the case of a crescent shape, at one end of the window the side faces of the window can contact each other, while the other end can be truncated. In this way, the indicator assembly can be arranged in such a way that the indicator area is initially located on the side of the window having the greatest width. In this way, the user can see a large part of the indicator element through the window. During injection of the medicine, the indicator disk rotates and simultaneously, the indicator element is turned towards the other end of the window, that is, towards the small / narrow end. In this way, the area of the indicator element seen by the user is reduced, which shows the user the progress of the injection, and also finally indicates to the user the end of the dose.
[0063] During a complete injection of a medication, the indicator disk preferably rotates, for example, between 90 ° and 180 °, that is, between a quarter and a half turn.
[0064] In an alternative embodiment, the drive mechanism of the injection indication mechanism is formed by a hub being coupled to the piston drive means, for example, to the piston driver. In addition, in this embodiment, the indicator assembly comprises a cover being fixed to the distal housing part. The cap is thus located away from the distal housing part and forms an extension of the housing at its distal end. In particular, the cap forms the distal surface of the injection device.
[0065] In this embodiment, the signaling element is a rotating element, preferably circular, like a wheel or disc.
[0066] The drive mechanism and the signaling element are preferably formed integrally, that is, as a part. For example, the rotating element comprises a nearby cylindrical protuberance, such as a wheel hub. Through this hub, the rotating element is connected and fixed to the distal end of the plunger driver.
[0067] The drive mechanism and the signaling element are received in the cover.
[0068] The signaling element can comprise an indication structure to inform the user that the device is ready for a medication injection, that the medication injection is in progress and that the medication injection has ended.
[0069] The display structure can comprise a plurality of segments being separated from each other by a plurality of ribs that project from the surface of the signaling element. Alternatively, the individual segments can be separated from each other by means of indentations on the surface of the signaling element.
[0070] The ribs protrude from the surface of the rotating disk by the mens in a distal direction and extend radially with respect to the radial center of the injection device. When the rotating disk rotates, the alternating structure of ribs / cutouts and segments passes through the windows. In a preferred embodiment, the segments and / or the ribs / cutouts comprise indicating elements. For example, the segment or rib shown in the window at the initial stage of the injection device contains a first indicating element, whereas the segment or rib shown in the window at the final injection position probably comprises a different second indicating element so that the user can easily distinguish the initial stage before injection from the final stage after injection of the drug. For example, the segments are colored in different colors. Alternatively, the angular widths of the segments can vary, for example, from a very small width to a large width to distinguish the starting position from the ending position.
[0071] As mentioned, the cover of the indication assembly can have at least one opening. In that embodiment of the invention, preferably two opposite openings / windows are provided. The two windows are opposite with respect to the central geometric axis of the injection device, that is, diameters are located. Through these openings, the user can see the signaling element. The window (s) is / are preferably placed in the transition between a lateral surface and an extreme distal surface of the lid. After the piston actuator is rotated by the first energy-accumulating element, the rotating element also rotates. This can be seen by the user through the windows. In this way, the user can easily see that the device works properly and that an injection is in progress.
[0072] In all embodiments, the rotating injection indication assembly / mechanism can be located distal from the first energy-accumulating element. It can also be located distal from the plunger drive means.
[0073] The injection device of the invention is particularly advantageous for highly viscous liquids having a viscosity of approximately 50 cP. For such liquids, the first energy-accumulating element preferably provides an average plunger force of 70 N (i.e., a low charge force of 60 N and a high charge force of 80 N). Brief Description of the Figures
[0074] The following figures below reveal an embodiment of the invention for purposes of illustration only. In particular, the disclosure in the figures is not intended to limit the scope of protection of the invention. The embodiments shown can be modified in many ways within the scope of the claims:
[0075] Figure 1 shows a perspective view of an injection device according to a first preferred embodiment of the invention;
[0076] Figure 2 shows a first detailed view of the injection device according to the first preferred embodiment of figure 1;
[0077] Figure 3 shows an additional detailed view of the injection device according to the first preferred embodiment of the invention;
[0078] Figure 4 shows an additional detailed view of the injection device according to the first preferred embodiment of the invention;
[0079] Figure 5 shows additional components of the injection device according to the preferred embodiment;
[0080] Figure 6 shows additional components of the injection device according to the preferred embodiment;
[0081] Figure 7 shows a sectional view of the injection device according to the preferred embodiment of the invention in the initial position;
[0082] Figure 8 shows a perspective view of the injection device according to the preferred embodiment of the invention in the initial position as shown in figure 7;
[0083] Figure 9 shows a perspective view of a second preferred embodiment of the invention;
[0084] Figure 10 shows a detail perspective view of the second preferred embodiment;
[0085] Figure 11 shows a detail perspective view of the second preferred embodiment;
[0086] Figure 12 shows a detail perspective view of the second preferred embodiment;
[0087] Figure 13 shows a perspective view of a third preferred embodiment of the invention; and
[0088] Figure 14 shows a detailed view of the indication assembly of the third preferred embodiment. Detailed Description of the Invention
[0089] Figure 1 shows a perspective view of an injection device according to a first preferred embodiment of the present invention. The injection device 1 has a housing comprising a close housing part 2, a distal housing part 3, a nearby intermediate housing part 4 (not shown in figure 1), and a distal intermediate housing part 5. In the state mounted of the injection device 1, the nearby housing part 2, the distal housing part 3, and the distal intermediate housing part 5 form the outer surface or appearance of the injection device
[0090] As shown in figure 1, the next housing part 2 comprises at least one window 6. In a preferred embodiment, two such windows are provided located on opposite sides of the next housing part 2. Such window allows the user to view the state of the injection, that is, if the injection device 1 is still in its initial stage with the medicine not yet being injected, or if the medicine container is already empty. Through window 6, the user can see the medicine container accommodated at least in the nearby housing part 2.
[0091] Furthermore, figure 1 shows the front cover 7 which closes the opening close to the next housing part 2 until the injection device 1 is used.
[0092] In figure 1, the outer end 41 of a spring can also be seen. This will be described in more detail below.
[0093] Figure 2 shows a first detailed view of the injection device 1 according to the first preferred embodiment of the present invention. In this detailed view of figure 2, the close housing part 2, the distal intermediate housing part 5 and the distal housing part 3, as well as the front cover 7 are shown "removed" from the injection device 1. In addition, the figure 2 shows the next intermediate housing part 4. The next intermediate housing part 4 is part of the housing in the injection device 1, but it is actually located inside (as clearly shown in the cross-sectional view of figure 7) to connect the close housing part 2 and the distal intermediate housing part 5 with each other. For this purpose, the outer surface of the next intermediate housing part 4 and the inner surfaces of the next intermediate housing part 2 and the distal intermediate housing part 5, respectively, are provided with corresponding engagement structures such as circumferential rib-notch structures, as shown in figure 2. In this way, the nearby housing part 2 and the distal intermediate housing part 5 can be easily fitted over the nearby intermediate housing part 4 so that the nearby housing part 2 and the intermediate housing part distal 5 do not fall from each other. However, the connection between these parts can be releasable so that a medication container can be inserted into or removed from the part close to the injection device 1.
[0094] As additionally shown in figure 2, the injection device according to the first embodiment of the invention comprises a medicine container holder 10. In the fully assembled state of the injection device 1, the medicine container holder 10 is at at least with its close part located within the close housing part 2. This will be described in more detail below with reference to figure 7. In the preferred embodiment shown in figure 2, the medicine container holder 10 comprises a first and a second container support 11. Preferably, the container support guides 11 are arranged on opposite sides of the container support 10, and extend in the longitudinal direction thereof. The container support guides 11 are received in corresponding notch structures provided on the inner surface of the nearby housing part 2 so that the medicine container support 10 is axially movable with respect to the housing, but is locked from being rotated with respect to to accommodation, in particular in relation to the nearby accommodation part 2.
[0095] Figure 2 also shows a needle protection glove 17 having a needle protection glove extension 18. At its distal end, the needle protection glove 17 comprises two tongue extensions 19 which are arranged at opposite locations, in relation to the longitudinal central geometric axis of the injection device 1. The part close to the needle protection sleeve 17 is generally cylindrical in shape. The closest part is a fully closed cylinder from which the two tongue extensions 19 protrude and extend towards the distal end of the injection device 1. In the preferred embodiment shown in the drawings, the tongue extensions 19 basically comprise three areas. The first closest area 191 is formed by two cylinder segments having the same radius / diameter as the nearest closed cylindrical part of the needle protection sleeve 17. The distal parts or areas 193 of the tongue extensions 19 are spaced apart by a greater distance than the diameter of the cylindrical part. Between these two areas, an intermediate area 192 is provided that forms a transition between the smaller diameter of the cylindrical area 191 and the greater distance at the distal end 193 of the tongue extensions 19. In general terms, the needle protection sleeve 17 has a widened configuration in which it widens from the near end towards the distal end thereof.
[0096] Figure 2 additionally shows the housing spring retainer 30 which is generally ring-shaped or substantially ring-shaped and coaxially arranged with the housing housing part 2. The housing spring retainer 30 surrounds a distal area of the medicine container support 10, i.e., it is located as shown in figure 2, radially between a distal area of the medicine container support 10 and the distal areas 193 of the tongue extensions 19. As shown in more detail in 4, the housing spring retainer 30 comprises two pins 31 which carry springs (not shown in FIG. 2) to push the needle sleeve 17 towards the near end of the injection device 1 when the injection device 1 is removed injection site after drug delivery was performed to cover the needle 13.
[0097] Figure 2 also shows the locking means of the container driver 25 being an element generically in the shape of a ring. The container driver locking means 25 is rotatable with respect to the housing and in engagement with the needle protection sleeve 17. This engagement is described in more detail below with reference to figures 3 and 4.
[0098] Container actuator 32 is located distal from container actuator locking means 25. Container actuator 32 is arranged to be connectable to container support 10, which will be described in further detail below.
[0099] Furthermore, figure 2 shows a first element of accumulating energy, that is, the first spring 40 that is used to perform an injection, and a second element of accumulating energy, for example, second spring 45 that is used to move axially the medicine container holder 10 to perform a needle penetration prior to the injection of the medicine.
[0100] Finally, figure 2 shows the indicator 80 to indicate the end of the dose.
[0101] Additional parts shown in figure 2 not yet discussed will be discussed in detail below.
[0102] Figure 3 shows an additional detailed view of the injection device 1, according to the preferred embodiment of the present invention.
[0103] In figure 3, needle guard sleeve 17, needle guard sleeve extension 18, and container trigger locking means 25 are shown "removed" from the injection device assembly. In addition, the nearby intermediate housing part 4 and the first spring 40 are shown as individual components in more detail.
[0104] In figure 3, one of two opposite notch structures 26 of the container driver locking means 25 is shown in more detail. Each notch structure 26 has two segments, namely, an inclined notch 261 and a longitudinal notch 262. In the initial position of the injection device 1, radial protrusions 20 formed on the inner surface of the distal areas 193 of the tongue extension 19 are located in the inclined notch 261 of the notch structures 26. When the injection device 1 is placed at an injection site, for example, on a user's skin, the needle protection sleeve 17 is thereby pushed or moved towards the distal end of the injection device 1. Such displacement of the needle guard sleeve 17 causes the protrusions 20 to move in the angled slots 261 towards the distal end of the container driver locking means 25 (which is shown by an arrow and stretched in the inclined notch 261 in figure 3). Since the container actuator locking means 25 is rotatable with respect to the housing, but longitudinally fixed (where it touches the container actuator 32), and the needle protection sleeve is rotationally locked, longitudinal displacement of the protective sleeve needle 17 towards the distal end of the injection device 1 results in a rotational movement of the container actuator locking means 25, allowing the protrusions 20 to slide towards the distal ends of inclined notches 261.
[0105] While the injection device is pressed at the injection site, that is, while the needle protection sleeve 17 is retained in its distal position, the protrusions 20 remain at the distal end of the notch structures 26. However, when the user removes the injection device 1 from the injection site, for example, after supplying medication, the needle protection glove 17 is induced to the near end of the injection device 1, as described above. During this movement, the projections 20 slide along longitudinal notches 262 and are locked at the ends close to longitudinal notches 262 by respective locking structures 28. This prevents the needle guard sleeve 17 from being able to be moved towards the distal end again injection device 1.
[0106] Figure 3 further shows in more detail the medicine container holder 10 with its two container holder guides 11. In addition, one of the two pins 31 of the housing spring retainer 30 extending parallel to the geometric axis longitudinal towards the end near the injection device is shown with its total length.
[0107] Figure 3 also shows a rigid needle guard remover 16. The rigid needle guard remover 16 comprises at its close end an engagement structure, like a circumferential rib on its outer surface, which is in engagement with a structure corresponding coupling on the inner surface of the front cover 7, for example, a corresponding notch (shown in figure 7). Due to such engagement, after removal of the front cover 7, the rigid needle guard remover 16 is removed from the medicine container 12. In addition, after removal of the rigid needle guard remover 16, the rigid needle guard comprising a portion soft 14 and a rigid part 15 (see figure 5) is also removed from the medication container 12 due to respective engagement structures engaging the two parts of the rigid needle guard and rigid needle guard remover 16 with each other.
[0108] Figure 3 also shows in more detail the container driver 32. The container driver 32 comprises at least one rotational locking rib 39. In the preferred embodiment, four rotational locking ribs 39 are provided, three of which are shown in figure 3. In the assembled state of the injection device 1, the rotational locking ribs 39 are located or received in corresponding locking notches 8 arranged on the inner surface of the nearby intermediate housing part 4. The locking ribs as well as the corresponding notches extend in the longitudinal direction. Such a structure prevents the container driver 32 from being rotated, that is, the container driver 32 is movable in the longitudinal direction in relation to the housing, but rotationally locked.
[0109] On its close side, the container driver 32 comprises at least one container driver arm 33. In the preferred embodiment shown in the drawings, two container driver arms 33 are arranged (see figure 4). The container actuator arms 33 individually comprise a latch opening 34 being configured to engage with corresponding enate protuberances 36 protruding from the container support tongue extensions 35 provided at the distal end of the container support 10. Thus , the medicine container support 10 is connected with the container driver 32, and the longitudinal displacement of the container driver 32 towards the near end of the injection device 1 (by the second spring 45) results in a movement of the medicine support 10 towards the end close to the injection device 1 through which a needle penetration is performed.
[0110] As can also be seen in figure 3, the container driver 32 comprises at least one shoulder 37. In the preferred embodiment, two shoulders 37 are provided (as can be seen in more detail in figure 4). With these projections 37, the container driver 32 initially abuts against stop ribs 27 located on the inner surface of the container driver locking means 25 (the stop ribs 27 are shown in figure 6). In this way, in the initial position of the injection device, that is, before its use, the container driver 32 and thus the medicine container support 10 are prevented from being moved in the near future because such movement is blocked by the locking means of container driver 25 due to the shoulder of the shoulder 37 against the stop ribs 27. Only after rotational movement of the container driver locking means 25 (caused by distal displacement of the needle protection sleeve 17), the stop ribs 27 are moved out of the way with the shoulders 37. In this way, the container driver is no longer axially locked / blocked by the container driver locking means 25.
[0111] Figure 3 also shows plunger actuator 50, plunger rod 60, and plunger actuation locking means 70. These components are described in more detail below.
[0112] Finally, as shown in figure 3, the first spring 40 comprises an outer end 41 that connects the first spring 40 to the housing, that is, the distal housing part 3, and an inner end 42 that connects the first spring 40 to the plunger driver 50. The outer end 41 can, for example, extend through a longitudinal slot in the distal housing part so that it can be engaged with the wall in the form of a hook. The first end 41 can be seen from the outside, as shown in figure 1. Alternatively, the first end of the spring 40 is engaged with a matched engagement structure provided on the inner surface of the distal housing part 3.
[0113] In the detailed view of figure 4, the injection device 1 of the preferred embodiment of the invention is further disassembled. In this figure, the housing spring retainer near 30, the container actuator 32 and the plunger actuation locking means 70 are shown "removed" from the assembly. In figure 4, the distal end of the medicine container support 10 is shown uncovered by the container driver 32. In this way, the two container support tongue extensions 35, each having an engaging protuberance 36, can be easily seen .
[0114] In addition, the two opposite arms 33 of the container driver 32 are shown. In the preferred embodiment, each arm comprises two portions, a first portion extending radially, and a second portion extending in a longitudinal direction to the near end of the injection device. Although in the preferred embodiment only two container trigger arms 33 and only two corresponding container support tongue extensions 35 are shown, the invention encompasses other configurations, such as only a single pair of protuberance arms, or a greater number of pairs of arms. bulge-arm, like three or four, for example. Similarly, the container driver 32 can have only a single rotational locking rib 39, however the invention also encompasses container drivers having two, three, five or six or even more rotational locking ribs. In addition, although the shoulder driver 37 for backing with the container driver locking means 25 only, other configurations having only one or three, four or more shoulders are also covered by the invention.
[0115] Figure 4 also shows the plunger actuation locking means 70. The plunger actuation locking means 70 has a generally cylindrical configuration (distal part 71) and comprises at its near end radial flange 72. The next flange 72 of the piston drive locking means 70 comprises at least one rotational locking element 73 projecting essentially radially. In the embodiment shown in the figures, two such locking elements 73 are provided. With these rotational locking elements 73, the plunger actuation locking means 70 is initially rotationally locked to the container driver 32. To provide such rotational locking, the container driver 32 comprises corresponding longitudinal ribs 75 on the inner surface of its distal part (shown in figure 7). The rotational locking elements 73 initially abut against these ribs 75. The axial length of these locking ribs 75 of the container actuator 32 is adapted to the length of the container actuator 32 and the medical container supports 10 are displaced / movable to perform a penetration needle. In more detail, the axial length of the locking ribs 75 is such that after the total displacement of the medicine container holder towards the injection site, the rotational locking elements 73 are finally released from engagement with the locking ribs 75. This means that at this stage the plunger drive locking means 70 is no longer rotationally locked by the container driver 32. In other words, when carrying out needle penetration, the container support 32 is moved longitudinally in relation to the locking means of piston drive 70. The piston drive locking means 70 is axially locked. Such an axial lock is provided by a locking structure 76 at the distal end of the piston actuating locking means 70 which is engaged with a corresponding structure at a distal end of the distal intermediate housing part 5 (shown in figure 7).
[0116] Figure 5 shows additional components of the injection device 1 according to the preferred embodiment.
[0117] As mentioned above, the medication container needle 13 is covered by a rigid needle guard consisting of a soft part 14 and a rigid part 15.
[0118] Figure 5 also shows plunger actuator 50 which is rotationally locked to the plunger actuation locking means 70, but slid in the axial direction in relation to the plunger actuation locking means 70. This will be described in more detail in context of figure 6.
[0119] The plunger rod 60 shown in figure 5 comprises a threaded structure 63 as well as at least one longitudinal notch 61. At the close end, the plunger rod 60 comprises a plunger rod tip 62 on which a pivoting element 65 is snap-fit. The turning element 65 acts on the cap on the medicine container 12.
[0120] Finally, figure 5 shows an indicator assembly to indicate the dose end, comprising an indicator 80, and a U-holder 81 disposed between the piston rod 60 and the plunger driver 50. The U-holder 81 is connected to the plunger actuation locking means 70 such that when the plunger rod 60 is advanced in close proximity and is not in contact with the U-bracket, the U-bracket, the indicator 80 and the indicator rod 82 are distally forced. Figure 5 also shows the indicator rod 82, being also part of the indicator assembly. A spiral spring (not shown in figure 5) is coaxially arranged on the indicator rod 82, where the spiral spring is arranged on the plunger rod 60. In this way, the indicator rod 82 with the spring is received in a central axial straight hole on the piston rod 60, while the support U 81 is arranged with its two legs on the two longitudinal notches 90 degrees opposite the two opposite longitudinal notches 61 of the piston rod 60.
[0121] Figure 6 shows the plunger driver 50. The plunger driver 50 comprises, in the shown embodiment, two internal longitudinal ribs 51. These longitudinal ribs 51 interact with longitudinal notches 61 on the outer surface of a plunger rod 60. Of this In this way, the piston rod 60 is rotationally locked to the piston driver 50, but it can slide axially along these ribs 51.
[0122] The plunger driver 50 further comprises a longitudinal slot 55 through its wall. With this longitudinal slot 55, the plunger driver 50 is connected to the inner end of the first spring 40. In this way, a force applied to the plunger driver 50 by the first spring 40 is transmitted to the plunger rod 60 due to the engagement of longitudinal ribs. internal 51 in longitudinal notches 61.
[0123] On the other hand, the plunger driver 50 comprises at least one external longitudinal rib 52. In the embodiment shown, four of these ribs are provided spaced 90 ° apart. The external longitudinal ribs 52 are slidably received in longitudinal notches 74 of the plunger drive locking means 70. In this way, while the plunger drive locking means 70 is prevented from being rotated due to the locking notch with the container driver. 32, the plunger actuator 50 and the plunger rod 60 are prevented from being rotated although the force of the first spring 40 acts on the plunger actuator 50. However, after the plunger actuation locking means 70 is free to rotate, the plunger driver 50 and the plunger rod 60 also begin to rotate, caused by the first spring 40. In the initial stage of the injection device 1, that is, before use, a part close to the plunger rod 60 is received in the central opening of the container driver 32. As shown in figure 6, the central opening of the container driver 32 comprises a threaded structure 38 which engages with the threads 63 of the piston rod 60. Thus, the next threaded section of the plunger rod 60 is threaded inside the container driver 32. Due to this threaded engagement, rotation of the plunger rod after use of the injection device results in an axial displacement of the plunger rod towards the end close to the injection device. In other words, the plunger rod 60 is rotated by the threaded engagement towards the medication container 12, and causes the cap (not shown) on the medication container support 12 and, in abutment with the turning element 65 , move towards the end near the medicine container holder to expel medicine. The torque force of the spring 40 will continue to drive the plunger rod towards the end close to the injection device 1 by pressing the cap to expel medicine through needle 13. Container driver 32 slides along the plunger rod 60 as that the plunger rod continues to move towards the end near the device. The injection is completed when the cap is at the end close to the medicine container.
[0124] When the plunger rod 60 is fully rotated towards the end close to the injection device 1, the two legs of the U-bracket 81 are no longer supported by the longitudinal notches of the plunger rod close to the U-bracket can disengage the slots in the plunger driver 50. The spiral spring (not shown) coaxially arranged with the indicator rod 82 causes the indicator assembly to move distally until the indicator 80 contacts the distal front surface of the distal housing part 3. This causes the that the distal protuberance of indicator 80 protrudes through the indicator opening 83 provided in the center of the distal wall of the distal housing part 3. This provides a visible and tactile indication to the user that the full dose has been expelled.
[0125] Figure 7 shows a sectional view of the injection device 1 according to the preferred embodiment of the present invention in the starting position. In particular, figure 7 shows how the second spring 45 is located inside the distal intermediate housing part 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 housing part 5 Alternatively, it may be in contact with a shoulder provided within the distal intermediate housing part, close to the distal radial wall of the distal intermediate housing part 5. The close end 47 of the second spring 45, on the other hand, abuts against a surface distal of the container driver 32.
[0126] The same cross-sectional view is shown in figure 8, however, as a perspective view to provide a different view of the various components in relation to each other and their mutual engagement. In addition, in figure 8 the relative arrangement of indicator 80, U-support 81, indicator rod 82, and distal injector opening 83 can be seen. Indicator rod 82 extends substantially into a central bore of plunger rod 60. At the distal end of the injection device 1, a distal part of the injector rod 82 extends beyond the distal end of the plunger rod 60, and is received in an internal central hole of indicator 80. Indicator rod 82 comprises a circumferential flange 84 adjacent to its distal end. Viewed in axial direction, between the circumferential flange 84 and the surface close to the indicator 80, the intermediate part of the U-support 81 is located. As seen in figure 5, this intermediate part of the U-support 81 comprises a direct hole through which the distal part of the indicator rod 82 extends. The two legs of the U-shaped support 81 extend axially towards the end close to the plunger rod 60. At their close ends, the two legs of the U-support 81 each comprise a radial leg 86. This radial leg 86 protrudes into corresponding radial openings in the plunger driver 50 (shown in figure 5).
[0127] Figure 9 shows a perspective view of a second preferred embodiment of the present invention. The injection device 100 shown in figure 9 is to a large extent identical to the injection device 1 according to the first preferred embodiment of the present invention. The same components are labeled with identical reference numerals. In the following, only the differences between the first and second preferred embodiments will be explained in detail.
[0128] As shown in figure 9, the injection device 100 is different from the injection device 1 with respect to the indicator assembly that is provided to show the end of the dose. The structure for needle penetration and drug injection shown in figures 2 to 6 is also present in the injection device 100 of figures 9 to 12.
[0129] The second preferred embodiment shown in figure 9 comprises an indicator assembly 180 provided at the distal end of the housing. That is, the indicator assembly is preferably located distal from the plunger driving means 50, 70 and / or distal from the first energy-accumulating element. The indicator assembly comprises a cover having at least one opening 181. In the embodiment shown in the drawings, two opposite openings / windows 181 are provided. The two windows are opposite with respect to the central geometric axis of the injection device, that is, diameters are located. Through these openings 181, the user can see a signaling element in the form of a rotating element, such as a wheel or disc 182, which is also shown in figure 10. The window (s) is / are preferably placed (s) ) in the transition between a lateral surface and a distal end surface of the lid.
[0130] As shown in figure 11, the rotating disk 182 comprises a nearby cylindrical protuberance 183, like a wheel hub. By means of this wheel hub 183, the rotating disk 182 is connected to the distal end of the plunger driver 50. Thus, after rotation of the plunger driver 50 by the first spring 40, the rotating disk 182 also rotates. This can be seen by the user through the windows 181. In this way, the user can readily see that the device works properly and that an injection is in progress.
[0131] As also shown in figure 11 and figure 12, the rotating disk comprises a distal indicating structure having a plurality of segments 184a, ..., 184i, ... 184n. These segments 184 alternate with radial ribs 185, that is, they are separated from each other by radial ribs. The ribs protrude from the surface of the rotating disc at least in a distal direction and extend radially with respect to the radial center of the injection device. When the rotating disk 182 rotates, the alternating structure of the ribs and segments passes through the windows 181. In a preferred embodiment, segments 184 and / or ribs 185 comprise indicating elements. For example, segment 184 or rib 185 shown in the window at the initial stage of the injection device 100 contains a first indicating element, whereas segment 184 or rib 185 shown in the window at the final injection position probably comprises a second element of injection. different indication so that the user can easily distinguish the initial stage before injection from the final stage after injection of the drug. For example, segments 184 are colored in different colors. Alternatively (not shown in the drawings), the angular widths of the segments can vary, for example, from a very small width to a large width to distinguish the starting position from the ending position.
[0132] Figure 13 shows a third preferred embodiment according to the present invention. The injection device 200 shown in figure 13 is identical to the injection devices 10 and 100 according to the first and second preferred embodiments, except for the indicator assembly provided at the distal end of the injection device 200. Thus, the structure for penetration needle and drug injection shown in figures 2 to 6 is also present in the injection device 200 of figures 13 and 14.
[0133] The injection device 200 comprises an indicator assembly 280. Figure 14 shows a detailed view of the indicator assembly 280. The indicator assembly 280 comprises a distal indicator assembly cover 281 which is mounted on the nearby housing part 3, for example, by means of a pressure fitting. On the distal surface being perpendicular to the longitudinal geometric axis of the injection device 200, an opening or window 282 is provided.
[0134] On indicator cover 281, a planetary gear assembly 283 is located. The solar wheel 284 of the planetary gear is connected to the piston driver 50 at the distal end thereof.
[0135] In addition, an indicator disk 286 is located axially between the planetary gear assembly 283 and the distal wall of the indicator cover 281. The indicator disk is coupled to the planetary gear by corresponding tooth structure. In this way, the rotation of the solar wheel is transmitted by gear in a rotation of the disk.
[0136] Indicator disk 286 comprises an indicator area 287. Indicator area 287 is distinguishable from the remaining area of indicator disk 286, for example, by means of a different color or a different texture. In the initial position of the injection device 200, the indicator assembly 280 is arranged in such a way that the indicator area 287 is located on one side of the window 282. In general terms, the window can have any type of crescent shape. Alternatively, it can be shaped like an L. Still alternatively, in the case of a crescent shape, at one end of the window the side faces of the window can contact each other (like side 289), while the end can be truncated (as side 288). In this way, the indicator assembly 280 can be arranged in such a way that the indicator area 287 is located on the side of the window having the largest width (side 288). In this way, the user can see a large part of the indicator element through window 282. During injection of the drug, indicator disk 286 rotates, and simultaneously, indicator element 287 is rotated to the other end of window 282, that is, in towards the small end 289. In this way, the area of the indicator element 287 seen by the user is reduced, which visualizes the progress of the injection for the user, and also indicates the end of the dose for the user.
[0137] During a complete injection of a medicine, the indicator disk preferably rotates, for example, between 90 ° and 180 °, that is, between a quarter and a half turn.
[0138] Figure 14 also shows indicator pin 285 which is also engaged with planetary gear assembly 283. Such pin 285 can optionally be provided to have an additional signaling element on the outer radial surface of the distal housing part 5, as seen in figure 13.
[0139] The second and third preferred embodiments comprise a rotary injection indication mechanism 180, 280 to indicate the progress of the injection to the user. These rotary injection indication mechanisms 180, 280 comprise a signaling element and a drive mechanism for rotationally driving the signaling element. The drive mechanisms are coupled to the plunger driver 50 at the distal end thereof. In addition, these rotating injection indication mechanisms are arranged in such a way that the progress of injection is shown through at least one opening provided at least on a distal end surface of the housing.
[0140] Although the invention has been illustrated and described in detail in the drawings and description above, such illustration and description should be considered illustrative or exemplary and not restrictive. It will be understood that changes and modifications can be made by those with common knowledge within the scope of the following claims. In particular, the present invention covers additional embodiments with any combination of characteristics of different embodiments described above and below.
[0141] Furthermore, in the claims the word “comprising” does not exclude other elements or stages, and the indefinite article “one” or “one” does not exclude a plurality. A single unit can serve the functions of several characteristics mentioned in the claims. The terms "essentially", "approximately", "about" and the like in connection with an attribute or a value particularly also define exactly the attribute or exactly the value, respectively. Any reference signs in the claims are not to be construed as limiting the scope.

权利要求:
Claims (22)
[0001]
1. Injection device comprising: a housing (2, 3, 4, 5), a container support (10), disposed within said housing, said container support (10) being configured to accommodate a medicine container ( 12) with a needle (13) connected to one end of it and a cap in a watertight and sliding way disposed inside said medicine container (12) at the other end of it, a drive unit comprising a piston rod ( 60) and piston actuating means (50, 70), the piston actuating means (50.70) being slidable in relation to the piston rod (60), being rotatably locked to the piston rod (60) and being rotatable in relation to the housing (2, 3, 4, 5), said drive unit, which further comprises a first energy accumulator element (40) disposed inside the injection device housing (1, 100, 200 ) and adapted to accumulate and store energy, where said piston drive means (50, 70) operatively associated with said first energy accumulator member (40), wherein the piston drive means (50, 70) can be released in such a way that, due to an output torque from said first energy accumulator element (40), the piston drive means (50, 70) are allowed to be rotated and the piston (60) is pushed towards the proximal end of the injection (1, 100, 200), so the injection is performed, and the injection device is characterized by the fact that it comprises a rotary injection indication mechanism (180, 280) configured to indicate the injection progress to the user , wherein the rotary injection indication mechanism (180, 280) comprises a signaling element and a drive mechanism for rotatingly driving said signaling element, said driving mechanism being coupled to said driving means of the piston (50, 70) at the distal end of said piston actuation means (50, 70), said rotary injection indication mechanism (180, 280) arranged so that the progress of the injection is shown through at least at least one opening provided at least on a distal end surface of the housing.
[0002]
2. Injection device, according to claim 1, characterized by the fact that said drive mechanism of said rotary injection indication mechanism (280) is formed by a planetary gear assembly (283), the solar wheel of same being coupled to said means of driving the plunger (50, 70).
[0003]
Injection device according to claim 1 or 2, characterized in that said signaling member (286) comprises at least one indication element to inform the user that the device is ready for a drug injection, which the drug injection is underway, and the drug injection has come to an end.
[0004]
Injection device according to claim 3, characterized in that said at least one indicating element is provided on a surface of the signaling element to which the longitudinal axis of the injection device is perpendicular.
[0005]
5. Injection device according to claim 4, characterized by the fact that said at least one indicating element faces the distal end of the injection device.
[0006]
Injection device according to any one of the preceding claims, characterized in that said signaling member (286) comprises a rotating disk, preferably circular.
[0007]
7. Injection device according to claim 1, characterized by the fact that said drive mechanism of said rotary injection indication mechanism (180) is formed by a hub (183) coupled to said piston drive means (50, 70).
[0008]
Injection device according to claim 7, characterized by the fact that said signaling member is an element that can preferably rotate circularly (182).
[0009]
9. Injection device according to claim 7 or 8, characterized by the fact that said signaling member comprises an indication structure to inform the user that the device is ready for an injection of medication, that the injection of medication is underway, and that the injection of medicine has come to an end.
[0010]
10. Injection device according to claim 9, characterized in that said indication structure comprises a plurality of segments (184a, ..., 184i, ..., 184N) being separated from each other by a plurality of ribs (185) protruding from the surface of the signaling member.
[0011]
Injection device according to any one of claims 7 to 10, characterized in that said drive mechanism and said signaling element are formed as one piece.
[0012]
12. Injection device according to any one of the preceding claims, characterized by the fact that said rotary injection indication mechanism (180, 280) is located distal to said first member of the energy accumulator (40).
[0013]
13. Injection device according to any one of the preceding claims, characterized by the fact that said rotary injection indication mechanism (180, 280) is located distal in relation to said piston movement means (50, 70) .
[0014]
Injection device according to any one of the preceding claims, characterized in that it further comprises: a container controller (32) arranged to be connected to the container support (10) and screwed on to the piston rod (60) ), said container controller (32) being operationally associated with a second member of the energy accumulator (45) such that, due to an axial output force from said second energy accumulator element (45), the container support (10) and the plunger rod (60) are movable axially in relation to the housing (2, 3, 4, 5) at a predetermined distance towards the proximal end of the injection device (1, 100, 200) from an initial locked position to a second position that a needle penetration is performed.
[0015]
15. Injection device according to claim 14, characterized in that, in the initial locked position, the piston drive means (50, 70) are blocked by the container driver (32) from being rotated.
[0016]
16. Injection device according to claim 14 or 15, characterized in that the injection device (1, 100, 200) further comprises means for locking the container controller (25) which can rotate in relation to the housing (2, 3, 4, 5) and for the container driver (32).
[0017]
Injection device according to any one of claims 14 to 16, characterized in that said container controller locking means (25) is configured to hold the container driver (32) in its initial locked position and to release said actuator from the container (32) from its initial locked position towards the proximal end of the injection device (1, 100, 200) to the second position.
[0018]
Injection device according to any one of claims 14 to 17, characterized in that said first member of the energy accumulator (40) comprises a first end connected to the piston drive means (50, 70) and a second end connected to the housing (2, 3, 4, 5).
[0019]
19. Injection device according to any one of claims 14 to 18, characterized in that said second energy accumulator element (45) is arranged in the longitudinal direction between said container driver (32) and a projection on the inner surface of the enclosure (2, 3, 4, 5).
[0020]
20. Injection device according to any one of the preceding claims, characterized by the fact that said injection device (1, 100, 200) further comprises a needle protection sleeve (17), arranged to slide in a proximal part of said body (2, 3) and being able to act on said locking means of the container controller (25) when said shielding needle sleeve (17) is pressed against an injection site.
[0021]
21. Injection device according to claim 20, characterized in that said needle protection sleeve (17) and said container actuator locking means (25) are operationally connected in such a way that the axial movement from said needle guard sleeve (17) to the distal end of the injection device causes said container drive locking means (25) to perform a pivoting motion.
[0022]
22. Injection device according to claim 21, characterized in that said rotational movement of said container controller locking means (25) results in a release of said container controller (32).

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同族专利:

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公开号 | 公开日

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ZA201400077B|2015-06-24|

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AU2012269771B2|2015-04-16|

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RU2014101288A|2015-07-27|

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EP2720737B1|2017-01-04|

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AU2012269771A1|2014-01-23|

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TW201313269A|2013-04-01|

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DK2720737T3|2017-04-10|

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BR112013032570A2|2017-01-17|

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CA2839496C|2016-02-09|

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ES2619701T3|2017-06-26|

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JP2014519923A|2014-08-21|

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KR101566132B1|2015-11-04|

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WO2012173554A1|2012-12-20|

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CN103732276A|2014-04-16|

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IL230001A|2018-04-30|

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KR20140027467A|2014-03-06|

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TWI507223B|2015-11-11|

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CA2839496A1|2012-12-20|

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JP5820528B2|2015-11-24|

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CN103732276B|2015-11-25|

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EP2720737A4|2015-09-02|

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US20140114247A1|2014-04-24|

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US9132236B2|2015-09-15|

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EP2720737A1|2014-04-23|

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法律状态:
2017-01-24| B15I| Others concerning applications: loss of priority|Free format text: PERDA DA PRIORIDADE US 61/498,542 DE 18/06/2011, CONFORME AS DISPOSICOES PREVISTAS NA LEI 9.279 DE 14/05/1996 (LPI) ART. 167O E NO ART. 29 DA RESOLUCAO INPI-PR 77/2013. ESTA PERDA SE DEU PELO FATO DE O DEPOSITANTE CONSTANTE DA PETICAO DE REQUERIMENTO DE ENTRADA NA FASE NACIONAL SER DISTINTO DAQUELE QUE DEPOSITOU O PEDIDO ANTERIOR CUJA PRIORIDADE E REIVINDICADA E APRESENTOU COPIA DO CORRESPONDENTE DOCUMENTO DE CESSAO EM 17/06/2014, CONTUDO O PRAZO PARA A APRESENTACAO DA CESSAO DO DIREITO DE PRIORIDADE EXPIRAVA EM 17/02/2014 (60 DIAS APOS A ENTRADA DA FASE NACIONAL DO BRASIL), CONFORME AS DISPOSICOES PREVISTAS NA LEI 9.279 DE 14/05/1996 (LPI) ART. 166O E NO ART. 28 DA RESOLUCAO INPI-PR 7 |

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2017-04-04| B12F| Appeal: other appeals|

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2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2020-02-11| B25A| Requested transfer of rights approved|Owner name: SHL MEDICAL AG (CH) |

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2020-02-18| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-09-01| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|

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2021-01-05| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-02-23| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 07/06/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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SE1150554-2|2011-06-17|

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SE1150554|2011-06-17|

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US201161498542P| true| 2011-06-18|2011-06-18|

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US61/498,542|2011-06-18|

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PCT/SE2012/050615|WO2012173554A1|2011-06-17|2012-06-07|Injection device|

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