injection device

专利摘要:
INJECTION DEVICE. The invention relates to an injection device comprising a housing, a container support, disposed within said housing, said container support being configured to accommodate a medicine container with a needle attached to one end of it and a airtight and sliding cap arranged inside said medicine container at the other end of it, a plunger rod arranged with a proximal end can be contacted by said plug, a first and a second energy accumulator element disposed inside the housing of the injection device and adapted to accumulate and store energy, the piston drive means being arranged slidable in relation to the piston rod, being rotatively locked to the piston rod and being rotatable in relation to the housing, said piston drive means being operationally associated with said first member of the energy accumulator, a c the container controller arranged to be connected to the container support and screwed connected to the piston rod, said container controller being operationally associated with said second energy accumulator element such that, due to an axial force (... ).
公开号:BR112013032569B1
申请号:R112013032569-0
申请日:2012-06-07
公开日:2020-12-29
发明作者:Stephan Olson；Anders Karlsson
申请人:Shl Medical Ag；
IPC主号:

专利说明:

Technical Field
[0001] The present invention relates to an injection device that has 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 drugs in fluid form that have high viscosity. Related Technique
[0002] The present invention relates to injection devices for injecting drugs in fluid form that have high viscosity, which means that these devices require high forces to press the fluid through a needle when injecting the drug.
[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 part of the body to activate it. The main concern was that the medication was injected as quickly as possible, without much concern for the patient or safety aspects. During the past few 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 the type of medicine, injection devices with a varying degree of automatic functions have also been developed to facilitate the injection of medicines in a reliable and safe way for patients and even for trained personnel, for example, doctors, nurses.
[0004] Autoinjector devices with an automated injection function often comprise a housing, a compression spring wound in a spiral that acts on a plunger rod which, in turn, acts on a stopper inside a medicine container to expel the medicine through a needle connected to the container. Normally, one end of the spring is often against an inner terminal surface of the housing, which means that the housing must be dimensioned for the strength of the spring. When high viscosity fluids are to be injected using an autoinjector, 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 as well as the thread diameter of the 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] WO 2009/037141 describes an automatic injection device comprising a housing and a container support positioned within said housing. The container support has a container adapted to contain a medicament to be supplied through a needle connected to the container and a sealing and sliding stopper positioned inside said container. The injection device further comprises a spring means positioned inside the device and adapted to store energy and a piston actuation means comprising a piston rod actuation element connected to said spring means and threaded to a stem plunger which is positioned with a proximal end in contact with said stopper so that, when said piston rod drive element is rotated due to an output torque from the spring means, the plunger rod is pushed in towards the proximal end of the device. The injection device further comprises a container actuation means positioned and designed to be fixedly connected to the container support and to be releasably connected to the piston rod so that, when said piston rod is pushed towards at the proximal end of the device, the container support is moved a predetermined distance towards the proximal end of the device, whereby penetration of the needle is performed and, after that, the continuous movement of said piston rod forces said means of actuation of the container to be released from said piston rod, whereby an injection is carried out.
[0006] The injection device of WO 2009/037141 uses a single spring means for needle penetration and subsequent injection of medication. However, for highly viscous liquids, the spring means must provide a respective high spring force in order to expel the medicine medication container. However, such a high spring force cannot be used to penetrate the previous needle into the injection site, as this would cause discomfort to the user and even damage the user's skin and tissue.
[0007] In addition, the use of a single spring for needle penetration and drug injection can increase the total diameter of the device. The diameter of the injection device depends mainly on the diameter of the spring. The greater the movement of the plunger, the greater the diameter of the spring. The use of the spring also for penetrating the needle further increases the diameter of the spring and thus of the device. Summary of the Invention
[0008] In order to overcome one or more of the problems mentioned above, an injection device according to independent claim 1 is provided.
[0009] Other aspects, improvements and variations are described in the dependent claims, figures and description.
[0010] In the present application, when the term "distal" is used, this refers to the direction away from the dose administration site. When the term "distal part / end" is used, this refers to the part / end of the delivery device or the parts / ends of limbs thereof, which are positioned further away from the site of dose administration. Correspondingly, when the term "proximal" is used, this refers to the direction that points to the location of dose administration. When the term "proximal part / end" is used, this refers to the part / end of the delivery device or the parts / ends of limbs thereof, which are positioned closest to the site of dose administration.
[0011] The injection device of the present invention comprises a housing and a container support positioned within the housing. The container holder is configured to accommodate a medicine container.
[0012] The housing may comprise a proximal housing part, a distal housing part, a proximal intermediate housing part and a distal intermediate housing part. In the assembled state of the injection device, the proximal 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 in which the housing comprises fewer or more housing parts. The housing parts may have a generally cylindrical configuration, such as a circular, elliptical, or square, or substantially square, cylindrical configuration.
[0013] A removable front cover can close the proximal opening of the housing.
[0014] In a preferred embodiment, the proximal intermediate housing part is coaxially positioned within the proximal housing part and the distal intermediate housing part, so that both overlap to form a connection structure to connect these two to one the other. The outer surface of the proximal intermediate housing part and the internal surfaces of the proximal housing part and the intermediate housing part can, respectively, therefore be provided with matching coupling structures. Such connection coupling can be provided with circumferential rib-groove structures and can be releasable.
[0015] However, it is also covered by the invention that the proximal housing part and the distal intermediate housing part are connected by other connection structures that do not require a proximal intermediate housing part.
[0016] The distal intermediate housing part may have a staggered configuration seen in the axial direction, so that a proximal part of it is part of the external appearance of the injection device, while a distal part of it has a smaller cross-sectional area with respect to the cross-sectional area of the proximal part, so that the proximal end of the distal housing part can overlap this part having a smaller cross-sectional area to connect the distal intermediate housing part and the distal housing part to each other. Again, circumferential groove-rib structures can be provided as a connection mechanism.
[0017] However, alternatively, the distal intermediate housing part may not have a staggered configuration, but, at its distal end, the same size and sectional shape as the distal housing part. In this case, the distal intermediate housing part and the distal housing part can be connected together, for example, by means of a coaxial sleeve positioned on the outside or inside of these parts and partially overlapping with both.
[0018] The medication container support is preferably at least with its proximal part positioned within the proximal housing part. The medicine container support can comprise one or more container support guides. Preferably, the container support guides are positioned longitudinally on opposite external sides of the container support. The container support guides are received in the corresponding groove structures provided on the inner surface of the proximal housing part, so that the medicine container support is axially movable and orientable with respect to the housing, but is prevented from rotating in relation to the housing, in particular in relation to the proximal housing part.
[0019] The medicine container is an optional component of the injection device because it can be inserted into the injection device by the user, for example, when 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 when dispensing the injection device.
[0020] The medicine container can be a commonly used medicine container that has a needle connected to one end of it and a sealing and sliding stopper positioned inside said medicine container at its other end.
[0021] In a preferred embodiment of the invention, the housing, for example, the proximal housing part, comprises at least one window. This window can extend axially over a given length of the housing. In a further preferred embodiment, more than one, for example, two such windows are provided. In the case of two windows, these can be positioned on opposite sides of the proximal housing part. This 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 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 proximal housing part. In addition, in the expelled state, the user can see the plunger rod through the window.
[0022] The injection device may further comprise a protective needle protector or sleeve positioned slidably in a proximal housing part and being able to act on a container actuator locking means when said protective needle sleeve is pressed against an injection site. The protective needle sleeve initially covers the needle of the medicine container. Thus, the needle is covered or retracted until the injection device is activated and cannot be contacted involuntarily until this moment. The protective needle sleeve is movable between a proximal and a distal position. The protective needle 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 proximal opening of the housing prevents the protective needle sleeve from being accidentally displaced before using the device.
[0023] At its distal end, the protective needle sleeve may comprise one or more, preferably two, tongue extensions. In the case of two tongue extensions, these can be positioned on opposite sides in relation to the central longitudinal axis of the injection device. The proximal part of the protective needle sleeve is preferably generally cylindrical in shape (assuming a generally cylindrical shape of the medicine container). The most proximal part is a fully closed cylinder from which the two tongue extensions protrude and extend from the proximal end of the protective needle sleeve a certain distance towards the distal end of the injection device. In a preferred embodiment, the tongue extensions comprise three areas. A first area, the most proximal, is formed by two cylinder segments that have the same radius / diameter as the most proximal closed cylindrical part of the needle protective sleeve. The distal parts or areas of tongue extensions are spaced from each other 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 smallest diameter of the cylindrical area and the largest distance at the distal end of the tongue extensions. In general terms, the protective needle sleeve has an enlargement configuration due to the fact that it extends from the proximal end towards the distal end thereof. Such a configuration can also be provided by tongue extensions which are inclined with respect to the longitudinal axis and having only one or two distinct areas.
[0024] 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 actuator locking means can be provided distal to the protective needle sleeve. The container driver locking means is configured to hold the container driver in its initial locked position and to release said container driver from its initial locked position towards the proximal end of the injection device to the second position.
[0025] In this way, the container actuator locking means constitutes a mechanism that prevents the container actuator (locking mechanism) from being activated, that is, being placed in a dispensing position before the device is ready for use. . Preferably, this functionality is provided by a configuration of the container driver locking means and the container driver, so that the activation of the container driver is prevented before the injection device is in contact with the injection site.
[0026] The container actuator locking means can be a generally ring-shaped element. The container driver locking means is preferably positioned close to the container driver.
[0027] In addition, the container actuator locking means is rotatable in relation to the housing and in coupling with the protective needle sleeve.
[0028] The protective needle sleeve and the container trigger locking means are preferably operationally connected, so that the axial movement of said protective needle sleeve towards the distal end of the injection device causes the said container actuator locking means performs a rotation movement. Such a rotational movement of the container driver locking means results in a release of said container driver.
[0029] Such operational connection can be checked by one or more groove structures provided on the external surface of the container actuator locking means. Each groove structure preferably has two segments, that is, an inclined groove, that is, a groove that is inclined with respect to the longitudinal axis of the device, and an axial longitudinal groove, that is, that extends parallel to the axis longitudinal direction of the device. In the initial position of the injection device, radial protrusions formed on the internal surface of the tongue-type extension are positioned in the inclined groove of the groove structures. When the injection device is placed at the injection site, the protective needle sleeve is thus pushed or moved towards the distal end of the injection device. Such displacement of the protective needle sleeve causes the protrusions to move inward or slide along the inclined groove towards the distal end of the container driver locking means. Since the container actuator locking means can rotate with respect to the housing, but it is longitudinally fixed (due to the fact that it rests against the container actuator), and the protective needle sleeve is rotatively blocked, the longitudinal displacement The protective needle sleeve towards the distal end of the injection device results in a rotational movement of the container actuator locking means, allowing the protrusions to slide towards the distal ends of the inclined grooves.
[0030] The injection device further comprises a container actuator that is configured to be connected to the container support and threadedly connected to a piston rod. The container actuator is operationally associated with an energy accumulator element (described in detail below) so that, due to an axial output force of said second energy accumulator element, the container support and the piston rod are of axially movable form in relation to the housing a predetermined distance towards the proximal end of the injection device from a blocked initial position to a second position, whereby penetration of the needle is carried out.
[0031] On its proximal side, the container driver preferably comprises at least one container driver arm. In a more preferred embodiment, two container driver arms can be present. The container driver arms each comprise a coupling opening configured for coupling, for example, with corresponding coupling protrusions that project 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 proximal end of the injection device results in a movement of the medicine container towards the proximal end of the injection device, whereby a needle penetration is performed.
[0032] The container driver can comprise at least one rotation locking rib. In a preferred embodiment, more than one, such as three or four rotation locking ribs, can be provided. In the assembled state of the injection device, the rotation locking ribs are positioned or received in corresponding locking grooves positioned on the inner surface of the proximal intermediate housing part. Preferably, the locking ribs, as well as the corresponding grooves, extend in the longitudinal direction. Such a structure prevents the container driver from rotating itself, that is, the container driver is movable in the longitudinal direction with respect to the housing, but rotatingly locked.
[0033] According to a preferred embodiment, the container driver comprises at least one shoulder. For example, two shoulders are provided. These lugs, for example, are positioned on a plane that is perpendicular to the longitudinal axis of the injection device to form partial circumferential supports so that, with these lugs, the container driver initially leans against the retaining ribs positioned on the inner surface of the container driver locking means. Thus, the container driver, on its proximal side, is partially overlapped by the container driver locking means. The retaining ribs are positioned proximal to the shoulders so that they form a stop against the proximal axial movement of the container driver. The retaining ribs can take the form of corresponding circumferential support projections. Thus, in the initial position of the injection device, that is, before its use, proximal movement of the container driver and, thus, of the medication container support, is prevented because such movement is blocked by the container driver locking means due to the support of the projections against the retaining ribs. Only when the container driver locking means rotationally move, the retaining ribs are moved out of the support with the shoulders. Thus, the container driver is no longer axially locked / locked by the container driver locking means.
[0034] The injection device also comprises at least one plunger rod which is positioned, with its proximal end, in contact with the stopper of the medicine container. The plunger rod comprises a threaded structure as well as at least one longitudinal groove on its outer surface. At the proximal end, the plunger rod may comprise a plunger rod tip on which an optional rotating member is fitted under pressure. The rotating element acts on the stopper in the medicine container. With its threaded structure, the piston rod is threaded through a central hole in the container driver that has a threaded coupling structure.
[0035] A piston drive means is positioned slidably in relation to the piston rod. The plunger drive means is also rotatably locked to the plunger rod and can rotate in relation to the housing. In addition, the piston drive means is operationally associated with another energy accumulator element.
[0036] The plunger actuation means preferably comprises a plunger actuator and a plunger actuator locking means. The plunger actuator locking means may have a distal part of generally cylindrical configuration and a proximal part which is formed by a proximal end radial flange. The proximal flange of the plunger actuation locking means may comprise at least one rotating locking element which projects in an essentially radial manner. In a preferred embodiment, two or more of such locking elements are provided. With these rotating locking elements, the plunger driver locking means is initially locked in rotation with the container driver. In order to provide such a rotary lock, the container driver comprises corresponding longitudinal ribs on the inner surface of its distal part. The rotating lock elements initially touch these ribs. In this way, the container driver overlaps, at least partially, with the plunger driver locking means positioned distally from the container driver. The axial length of these container actuator locking ribs is adapted to the length of the container actuator and the medication container supports are displaced / displaceable to effect a needle penetration. In greater detail, the axial length of the locking ribs is such that, when the medicine container holder is fully displaced to the injection site, the rotational locking elements are finally released from the coupling with the locking ribs. This means that, at this stage, the plunger driver locking means is no longer rotatively blocked by the container driver. In other words, when carrying out the needle penetration, the container support is moved longitudinally in relation to the plunger driver locking means. The plunger actuator locking means are axially locked. Such an axial lock is provided by a locking structure at the distal end of the piston actuator locking means which is coupled with a corresponding structure at a distal end of the distal intermediate housing part.
[0037] The plunger actuator is rotatively locked to the plunger actuator locking means, but slid in the axial direction in relation to the plunger actuator locking means. The plunger driver can comprise two internal longitudinal ribs. These longitudinal ribs interact with longitudinal grooves on the outer surface of a piston rod. In this way, the piston rod is rotatably locked to the piston driver, but it can slide axially along these ribs.
[0038] 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 storage element. Thus, a force applied to the piston driver by the energy accumulator element is transmitted to the piston rod by virtue of the coupling of internal longitudinal ribs in longitudinal grooves.
[0039] On the other hand, the plunger driver can comprise at least one external longitudinal rib. For example, four such ribs spaced 90 ° from each other are provided. The external longitudinal ribs are slidably received in longitudinal grooves of the piston actuator locking means. Thus, to the extent that the plunger actuator locking means cannot rotate due to the locking coupling with the container actuator, rotation of the plunger actuator and the plunger rod is prevented, although the force of the first spring act on the plunger driver. However, once the plunger actuator locking means is released to rotate, the plunger actuator and the plunger rod also begin to rotate by virtue of the first spring. In the initial stage of the injection device, that is, before use, a proximal part of the plunger rod is received at the central opening of the container driver. The central opening of the container driver comprises a threaded structure that engages with the threads of the piston rod. Thus, the threaded proximal section of the plunger rod is threaded inside the container driver. Due to this threaded coupling, the rotation of the plunger rod after 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 is rotated by the threaded coupling towards the medicine container and causes the stopper in the medicine container holder to move towards the proximal end of the medicine container holder to expel medicine. The torsional force of the spring will continue to propel the plunger rod towards the proximal end of the injection device, pressing the stopper to expel the medication through the needle. The container driver slides along the plunger rod when the plunger rod continues to move towards the proximal end of the device. The injection is completed when the stopper is at the proximal end of the medicine container.
[0040] Thus, the container actuator forms a locking mechanism that is configured to substantially inhibit the release of the drug when it is in an initial locking position. Preferably, when in a locked position, the locking mechanism is configured to substantially inhibit the movement of at least one plunger rod relative to other parts of the device. Preferably, the container driver (locking mechanism) is configured to substantially inhibit movement of the plunger rod in a proximal direction when it is in a locking position. More preferably, the locking mechanism is configured to substantially inhibit movement of the plunger rod in a proximal direction along the longitudinal axis of the device when it is in a locking position.
[0041] Preferably, the container driver is configured to allow the release of medication when it is in at least one dispensing position, that is, in a second position. When in the second position after needle penetration has been performed, the container driver is preferably configured to allow administration of medication by injection. Preferably, when in a dispensing position, the container driver is configured to allow at least a certain movement of at least one piston rod in the proximal direction with respect to other parts of the device along the longitudinal axis of the device.
[0042] The movement of the plunger rod in the proximal direction preferably leads to at least one medication being expelled from at least one medication container. The medicament is preferably in a liquid state and the medicament container is preferably positioned in the medicament container holder.
[0043] In addition, according to the invention, a first energy accumulator element and a second energy accumulator element are positioned inside the injection device housing 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 positioned at the distal end of the injection device, within the distal housing part. The second energy accumulator element is used to axially move the medicine container holder to perform a needle penetration prior to injection of medicine. In this way, needle penetration and drug distribution are dissociated by the fact that different energy-accumulating elements are used.
[0044] The first energy accumulator element of the injection device may comprise a first end connected to the plunger driving means and a second end connected to the housing, for example, the distal housing part. Preferably, the first energy accumulator element is a spring of constant force. For example, the first energy-accumulating element is a spiral spring.
[0045] The second energy storage element can be positioned between the container driver and a shoulder on the internal surface of the housing. The second energy accumulator element can be a spiral spring or helical spring positioned coaxially with the longitudinal axis of the injection device. In particular, the distal end of the second energy accumulator element can 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 proximal end of the second energy accumulator element, on the other hand, abuts against a flat surface of the container driver.
[0046] The injection device may further comprise resilient means for pressing the needle protector or protective sleeve towards the proximal end of the injection device when the injection device is removed from the injection site. Thus, preferably, the protective needle sleeve covers the needle when the injection device is removed from the injection device.
[0047] The injection device may further comprise a locking means for locking the protective needle sleeve against movement 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 groove structures. However, when the user removes the injection device from the injection site, the protective needle sleeve is pushed towards the proximal end of the injection device. During this movement, the protrusions slide from the inclined groove into the longitudinal groove (which is connected at its distal ends to form a type of V shape) and slide along the longitudinal grooves. The protrusions are then blocked at the proximal ends of the longitudinal grooves by respective locking structures.
[0048] Consequently, the protective needle sleeve according to the invention is movable or movable. More preferably, after the device has been used, the protective needle sleeve is moved and locked in a distal position when the device is removed from the dose delivery site. The protective needle sleeve is preferably forced in a proximal direction by the force of at least one spring. The spring (s) can be provided in the distal area of the protective needle sleeve. Thus, the protective needle sleeve is a protective element, such as a needle protective element or protective needle sleeve that protects the user against accidental or inadvertent contact with the needle, which may be contaminated.
[0049] Such proximal displacement of the needle sleeve may be permitted by a spring retainer of the proximal housing which may be generally ring-shaped or substantially ring-shaped and coaxially positioned with the proximal housing part. The proximal housing spring retainer may involve a distal area of the medication container support, viewed radially between a distal area of the medication container support and the distal areas of tongue extensions. The retainer may comprise one or more spring-loaded pins to push the needle sleeve toward the proximal end of the injection device when the injection device is removed from the injection site after drug delivery has been made to cover the needle.
[0050] Thus, the needle protective sleeve locking means is preferably formed by the container driver locking means. The operational connection between the protective needle sleeve and the container driver locking means can be formed by a groove mechanism.
[0051] The injection device may also comprise an injection indicator mechanism to indicate the injection progress to the user. The signal can be a visible or tactile signal.
[0052] The injection indicator mechanism can be an axial injection indicator mechanism to indicate to the user that the medication injection has been completed. Such an axial injection indicator mechanism may comprise a signaling element and a drive mechanism for axially driving said signaling element. The drive mechanism is preferably coupled to the piston drive means. The axial injection indicator mechanism can be positioned so that a visible and tactile signal indicates the end of the injection to the user.
[0053] According to an embodiment of the invention, an indicator assembly for indicating the end of a dose comprises an indicator and a U-shaped support positioned between the piston rod and the piston driver. The U-bracket is connected to the plunger actuator blocking means so that when the plunger rod is advanced proximally and is not in contact with the U-bracket, the U-bracket and the plunger driver are forced into the distal direction. The assembly further comprises an indicator rod which is also part of the indicator assembly. A spiral spring is positioned coaxially on the indicator rod, where the spiral spring is positioned inside the piston rod. Thus, the indicator rod with the spring is received inside a central axial hole, through the piston rod, while the U-shaped support resides with its two legs in the two opposite longitudinal grooves of the piston rod.
[0054] When the piston rod is fully rotated towards the proximal end of the injection device, the two legs of the U-bracket are no longer supported by the longitudinal grooves of the piston rod. Thus, the radial legs at the proximal ends of the U-bracket can disengage from the slots in the plunger driver. The coaxial spiral spring with the indicator rod causes the indicator assembly to move in the distal direction until the indicator contacts the distal front surface of the distal housing part. This causes the distal protrusion of the indicator to project through the opening of the indicator provided in the center of the distal wall of the distal housing part. This provides a visible and tactile indication to the user that the total dose has been expelled.
[0055] The injection device of the invention is particularly advantageous for viscous liquids that have a high viscosity of approximately 50 cP. For such liquids, the first energy accumulator element preferably provides an piston force of 70 N on average (i.e., a low loading force of 60 N and a high loading force of 80 N). Brief Description of Drawings
[0056] The following figures below describe an embodiment of the invention for illustrative purposes only. In particular, the description within the figures is not intended to limit the scope of protection of the invention. The shown embodiment can be modified in many ways within the scope of the claims: Figure 1 shows a perspective view of an injection device according to a first preferred embodiment of the invention; Figure 2 shows a first exploded view of the injection device according to the first preferred embodiment of Figure 1; Figure 3 shows another exploded view of the injection device according to the first preferred embodiment of the invention; Figure 4 shows another exploded view of the injection device according to the first preferred embodiment of the invention; Figure 5 shows other components of the injection device according to the preferred embodiment; Figure 6 shows other components of the injection device according to the preferred embodiment; Figure 7 shows a sectional view of the injection device according to the preferred embodiment of the invention in the initial position; 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; Figure 9 shows a perspective view of a second preferred embodiment of the invention; Figure 10 shows a detail perspective view of the second preferred embodiment; Figure 11 shows a detail perspective view of the second preferred embodiment; Figure 12 shows a detail perspective view of the second preferred embodiment; Figure 13 shows a perspective view of a third preferred embodiment of the invention; and Figure 14 shows an exploded view of the indicator assembly of the third preferred embodiment. Detailed Description of Drawings
[0057] 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 proximal housing part 2, a distal housing part 3, a proximal intermediate housing part 4 (not shown in Figure 1) and a distal intermediate housing part 5. In the assembled state of the injection device 1, the proximal 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 1.
[0058] As shown in Figure 1, the proximal housing part 2 comprises at least one window 6. In a preferred embodiment, two such windows are provided positioned on opposite sides of the proximal housing part 2. This window allows the user to see the status of the injection, that is, if the injection device 1 is still in its initial stage with the drug not yet injected, or if the drug container is already empty. Through window 6, the user can see the medicine container accommodated at least in the proximal housing part 2.
[0059] In addition, Figure 1 shows the front cover 7, which closes the proximal opening of the proximal housing part 2 until the injection device 1 is used.
[0060] In Figure 1, the outer end 41 of a spring can also be seen. This will be described in more detail below.
[0061] Figure 2 shows a first exploded view of the injection device 1 according to the first preferred embodiment of the present invention. In this exploded view of Figure 2, the proximal 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, Figure 2 shows the proximal intermediate housing part 4. The proximal intermediate housing part 4 forms the housing part of the injection device 1 but is actually positioned inside (as clearly shown in the cross-sectional view of Figure 7) , in order to connect the proximal housing part 2 and the distal intermediate housing part 5 with each other. For this purpose, the outer surface of the proximal intermediate housing part 4 and the internal surfaces of the proximal housing part 2 and the distal intermediate housing part, respectively, are provided with corresponding coupling structures, such as circumferential groove structures. rib, as shown in Figure 2. Thus, the proximal housing part 2 and the distal intermediate housing part 5 can be easily coupled over the proximal intermediate housing part 4, so that the proximal housing part 2 and the distal intermediate housing 5 do not disengage from each other. However, the connection between these parts can be releasable, so that a medication container can be inserted or removed from the proximal part of the injection device 1.
[0062] As further 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 proximal part positioned within the proximal housing part 2. This will be described in greater detail below with reference to Figure 7. In the preferred embodiment shown in Figure 2, the medication container holder 10 comprises a first and a second guide container support guides 11. Preferably, the container support guides 11 are positioned on opposite sides of the container support 10 and extend in the longitudinal direction thereof. The container support guides 11 are received in corresponding groove structures provided on the inner surface of the proximal housing part 2, so that the medicine container support 10 is axially movable in relation to the housing, but its rotation is hindered in relation to the housing, in particular in relation to the proximal housing part 2.
[0063] Figure 2 also shows the protective needle sleeve 17 which has, at its proximal end, an extension of the protective needle sleeve 18. At its distal end, the protective needle sleeve 17 comprises two tongue extensions 19 that they are positioned on opposite sides in relation to the longitudinal central axis of the injection device 1. The proximal part of the protective needle sleeve 17 is generally cylindrical in shape. The most proximal part is a completely 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 most proximal area 191 is formed by two cylindrical segments that have the same radius / diameter as the most proximal closed cylindrical part of the protective needle sleeve 17. The distal parts or areas 193 of the tongue extensions 19 are spaced apart from each other distance greater than the diameter of the cylindrical part. Between these two areas, an intermediate area 192 is provided which forms a transition between the smaller diameter of the cylindrical area 191 and a greater distance at the distal end 193 of the tongue extensions 19. In general terms, the protective needle sleeve 17 has a configuration enlarged in the sense that it extends from the proximal end towards the distal end thereof.
[0064] Figure 2 also shows a proximal housing spring retainer 30, which is generally or substantially ring-shaped, and positioned coaxially with the proximal housing part 2. The proximal housing spring retainer 30 surrounds a distal area of the medicine container holder 10 in a ring shape, i.e., it is positioned as shown in Figure 2, radially between a distal area of the medicine container holder 10 and the distal areas 193 of the tongue extensions 19. As shown in greater detail in Figure 4, the proximal housing spring retainer 30 comprises two spring-loaded pins 31 (not shown in Figure 2) to push the protective 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 has been completed to cover needle 13.
[0065] Figure 2 also shows a means of locking the container driver 25 as a generally ring-shaped element. The container actuator locking means 25 is rotatable with respect to the housing and is in coupling with the protective needle sleeve 17. This coupling is described in greater detail below with reference to Figures 3 and 4.
[0066] Distal from the container actuator locking means 25, the container actuator 3 is positioned. The container actuator 32 is positioned to be connected to the container support 10, which will be described in greater detail below.
[0067] In addition, Figure 2 shows a first energy accumulator element, that is, first spring 40, which is used to perform an injection, and a second energy accumulator element, for example, second spring 45, which is used to axially move the medicament container holder 10 so as to perform a needle penetration prior to injecting the medicament.
[0068] Finally, Figure 2 shows the indicator 80 for indicating the end of a dose.
[0069] Other components shown in Figure 2 not yet discussed will be discussed in detail below.
[0070] Figure 3 shows another exploded view of the injection device 1 according to the preferred embodiment of the present invention.
[0071] In Figure 3, the protective needle sleeve 17, the protective needle sleeve extension 18 and the container trigger locking means 25 are shown "removed" from the injection device assembly. In addition, the proximal intermediate housing part 4 and the first spring 40 are shown as individual components in greater detail.
[0072] In Figure 3, one of the two opposite groove structures 26 of the container driver locking means 25 is shown in greater detail. Each groove structure 26 has two segments, that is, an inclined groove 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 areas 193 of the tongue-type extension 19 are positioned in the inclined groove 261 of the longitudinal groove structure 262. When the injection device 1 is placed in an injection site, for example, the skin of a user, the protective needle sleeve 17 is thus pushed or moved towards to the distal end of the injection device 1. Such displacement of the protective needle 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 a arrow and drawn in the slotted groove 261 in Figure 3). Since the container actuator locking means 25 is rotatable with respect to the housing, but longitudinally fixed (due to the fact that it rests against the container actuator 32) and the protective needle sleeve is rotatively blocked, the longitudinal displacement the protective needle sleeve 17 towards the distal end of the injection device 1 results in a rotational movement of the container driver locking means 25, allowing the protrusions 20 to slide towards the distal ends of inclined grooves 261.
[0073] As the injection device is pressed at the injection site, that is, while the protective needle sleeve 17 is held in its distal position, the protrusions 20 remain at the distal end of the groove structures 26. However , when the user removes the injection device from an injection site, for example, after dispensing medication, the needle protective sleeve 17 is pushed towards the proximal end of the injection device 1, as described above. During this movement, the protrusions 20 slide along longitudinal grooves 262 and are blocked at the proximal ends of the longitudinal grooves 262 by respective locking structures 28. This prevents the needle shield sleeve 17 from being able to move again towards the distal end of the injection device 1.
[0074] Figure 3 shows in even greater detail the medicine container support 10 with its two container support guides 11. In addition, one of the two pins 31 of the proximal housing spring retainer 30 that extends parallel to the longitudinal axis towards the proximal end of the injection device is shown in its full length.
[0075] Figure 3 also shows the rigid needle guard remover 16. The rigid needle guard remover 16 comprises, at its proximal end, a coupling structure, such as a circumferential rib on its outer surface, which is in coupling with a corresponding coupling structure on the inner surface of the front cover 7, for example, a corresponding groove (shown in Figure 7). By virtue of such coupling, when removing the front cover 7, the rigid shield remover 16 is removed from the medicine container 12. Furthermore, after the removal of the rigid shield remover 16, the rigid needle guard comprising a part soft 14 and a rigid part 15 (see Figure 5) is also removed from the medication container 12 by virtue of the respective coupling structures that couple the two parts of the rigid needle guard and the rigid needle guard remover 16 with each other.
[0076] Figure 3 also shows, in greater detail, the container driver 32. The container driver 32 comprises at least one rotation locking rib 39. In the preferred embodiment, four rotation locking ribs 39 are provided, three of which are shown in Figure 3. In the assembled state of the injection device 1, the rotation locking ribs 39 are positioned or received in locking grooves 8 positioned on the inner surface of the proximal intermediate housing part 4. The locking ribs , as well as the corresponding grooves, extend in the longitudinal direction. Such a structure prevents rotation of the container driver 32, that is, the container driver 32 is movable in the longitudinal direction with respect to the housing, but rotatingly locked.
[0077] On its proximal side, the container actuator 32 comprises at least one container actuator arm 33. In the preferred embodiment shown in the drawings, two container actuator arms 33 are positioned (see Figure 4). The container driver arms 33 each comprise a coupling opening 34 which is configured for coupling with corresponding coupling protrusions 36 that project 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 proximal end of the injection device 1 (by the second spring 45) results in a movement of the support of drug 10 towards the proximal end of the injection device 1, whereby penetration of the needle is performed.
[0078] As can also be seen in Figure 3, the container driver 32 comprises at least one protrusion 37. In the preferred embodiment, two protrusions 37 are provided (as can be seen in greater detail in Figure 4). With these protrusions 37, the container driver 32 initially leans against the retaining ribs 27 located on the inner surface of the container driver locking means 25 (the retaining ribs 27 are shown in Figure 6). Thus, in the initial position of the injection device, that is, before its use, proximal movement of the container driver 32 and, thus, of the medicine container support 10, is prevented because such movement is blocked by the actuator locking means of container 25 due to the support of protrusions 37 against the retaining ribs 27. Only when the container actuator locking means 25 rotates (caused by the distal displacement of the protective needle sleeve 17), the retaining ribs 27 they are moved out of the support with protrusions 37. In this way, the container driver is no longer blocked / axially locked by the container driver locking means 25.
[0079] Figure 3 also shows plunger driver 50, plunger rod 60 and plunger driver locking means 70. These components are described in more detail below.
[0080] Finally, as shown in Figure 3, first spring 40 comprises an outer end 41 which connects the first spring 40 to the housing, that is, the distal housing part 3, and an inner end 42 which 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 attached to the wall in the form of a hook. The first end 41 can then be seen on the outside, as shown in Figure 1. Alternatively, the first end of the spring 40 is coupled to a corresponding coupling structure provided on the inner surface of the distal housing part 3.
[0081] In the exploded view of Figure 4, the injection device 1 of the preferred embodiment of the invention is still disassembled. In this drawing, the proximal housing spring retainer 30, container actuator 32 and plunger actuator locking means 70 are shown "removed" from the assembly. In Figure 4, the distal end of the medication container holder 10 is shown uncovered by the container driver 32. Thus, the two tongue extensions of the container holder 35, each having a coupling protrusion 36, can be easily seen.
[0082] 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 that extends radially and a second portion that extends in the longitudinal direction towards the proximal end of the injection device. Although, in the preferred embodiment of the actuator, only two container arms 33 and only two corresponding container tongue extensions 35 are shown, the invention encompasses other configurations, such as only a single protruding arm pair or a greater number of pairs of arms. protruding arm, such as three or four, for example. Similarly, the container driver 32 may have only a single rotation locking rib 39, but the invention also encompasses container drivers that have two, three, five or six or even more rotation locking ribs. In addition, although the container driver 32 shown in Figure 4 comprises two shoulders 37 to support against the container driver locking means 25, other configurations having only one or three, four or more protrusions are also covered by the invention.
[0083] Figure 4 also shows the plunger actuator blocking means 70. The plunger actuator blocking means 70 is of generally cylindrical configuration (distal part 71) and comprises, at its proximal end, a radial flange 72. The proximal flange 72 of the plunger actuator locking means 70 comprises at least one rotational locking element 73 which extends essentially radially. In the embodiment shown in the Figures, two of such locking elements 73 are provided. With these rotation locking elements 73, the means 70 is rotationally locked initially in relation to the container driver 32. In order to provide such a rotation lock, the piston driver 32 comprises corresponding longitudinal ribs 75 on the inner surface of its part distal (shown in Figure 7). The rotation locking elements 73 initially support against these ribs 75. The axial length of these locking ribs 75 of the container driver 32 is adapted to the length of the container driver 32 and the medicine container supports 10 are displaced / displaced to perform a needle penetration. In greater detail, the axial length of the locking ribs 75 is such that, when the medicine container holder is completely moved to the injection site, the rotating locking elements 73 are finally released from the coupling with the locking ribs 75 This means that, at this stage, the medium 70 no longer has the rotation blocked by the container driver 32. In other words, when the needle penetrates, the container holder 32 is moved longitudinally in relation to the medium locking means. piston driver 70. The piston driver 70 locking means is axially locked. Such an axial lock is provided by a locking structure 76 at the distal end of the piston actuator locking means 70 which is coupled with a corresponding structure at a distal end of the distal intermediate housing part 5 (see Figure 7).
[0084] Figure 5 shows other components of the injection device 1 according to the preferred embodiment.
[0085] As mentioned above, the needle 13 of the medication container 12 is covered by a rigid needle protector consisting of a soft part 14 and a rigid part 15.
[0086] Figure 5 also shows the plunger driver 50, which is rotatably locked to the plunger driver locking means 70, but which can slide in the axial direction in relation to the plunger driver locking means 70. This will be described in greater detail in the context of Figure 6.
[0087] The plunger rod 60 shown in Figure 5 comprises a threaded structure 63, as well as at least one longitudinal groove 61. At the proximal end, the plunger rod 60 comprises a plunger rod tip 62 on which a rotating element 65 is fitted under pressure. The pivoting element 65 acts on the stopper in the medicine container 12.
[0088] Finally, Figure 5 shows an indicator set for indicating the end of a dose comprising an indicator 80 and a U-holder 81 positioned between the plunger rod 60 and the plunger driver 50. The U-holder 81 is connected to the plunger actuator locking means 70 so that when the plunger rod 60 is advanced proximally and is not in contact with the U-bracket, the U-bracket, the indicator 80 and the indicator rod 82 are forced in the distal direction. Figure 5 also shows the indicator rod 82, also being part of the indicator assembly. A spiral spring (not shown in Figure 5) is positioned coaxially over indicator rod 82, where the spiral spring is positioned inside piston rod 60. Thus, indicator rod 82 with the spring is received inside from a central axial orifice, through the piston rod 60, while the U-shaped bracket 81 resides with its two legs on the two longitudinal grooves opposite 90 degrees to the two opposite longitudinal grooves 61 of the piston rod 60.
[0089] 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 the longitudinal grooves 61 on the outer surface of a piston rod 60 Thus, the piston rod 60 is rotatably locked to the piston driver 50, but it can slide axially along these ribs 51.
[0090] 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 by virtue of the coupling of the ribs internal longitudinal slots 51 within the longitudinal slots 61.
[0091] On the other hand, the plunger driver 50 comprises at least one external longitudinal rib 52. In the embodiment shown, four of such ribs are provided spaced 90 ° apart. The external longitudinal ribs 52 are slidably received in longitudinal grooves 74 of the piston actuator locking means 70. Thus, while rotation of the piston actuator locking means 70 is prevented by coupling the actuator locking means container 32, rotation of the plunger actuator means 50 and plunger rod 60 is prevented, although the force of the first spring 40 acts on the plunger actuator 50. However, since the rotation of the actuator locking means the plunger 70 is released, the plunger driver 50 and the plunger rod 60 also begin to rotate due to the first spring 40. In the initial stage of the injection device 1, that is, before its use, a proximal part of the piston rod plunger 60 is received at 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 that engages with the threads 63 of the plunger rod 60. Thus, the threaded proximal section of the piston rod 60 is threaded inside the container driver 32. Due to this threaded coupling, rotation of the piston rod when using the injection device results in an axial displacement of the piston rod towards the end proximal to the injection device. In other words, the plunger rod 60 is rotated by the thread towards the medicine container 12 and causes the stopper (not shown) in the medicine container holder 12 and in contact with the rotating element 65 to move towards the proximal end of the medicine container holder in order to expel the medicine. The torque force of the spring 40 will continue to drive the plunger rod towards the proximal end of the injection device 1, pressing the stopper to expel the medication through needle 13. The container driver 32 slides along the plunger rod 60 as the plunger continues to move towards the proximal end of the device. The injection is completed when the stopper is at the proximal end of the medicine container.
[0092] When the piston rod 60 is fully rotated towards 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 piston rod 60. Thus, the radial legs 86 at the proximal ends of the U-bracket they can disengage from the slots in the plunger driver 50. The spiral spring (not shown) positioned coaxially 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 distal protrusion of indicator 80 to project through the opening of indicator 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 complete dose has been expelled.
[0093] 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 positioned 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 protrusion provided within the distal intermediate housing part, proximal to the distal radial wall of the distal intermediate housing part 5. The proximal end 47 of the second spring 45, on the other hand, rests against a distal surface of the container driver 32.
[0094] The same cross-sectional view is illustrated in Figure 8, however, a perspective view, in order to provide a different point of view of the various components in relation to each other and their interconnection. In addition, in Figure 8, the relative location of indicator 80, U-holder 81, indicator stem 82 and distal opening 83 of the injector can be seen. Indicator rod 82 extends substantially within a central hole of plunger rod 60. At the distal end of injection device 1, a distal part of injector rod 82 extends beyond the distal end of plunger rod 60 and is received in an inner central hole of indicator 80. Indicator stem 82 comprises a peripheral flange 84 adjacent to its distal end. Viewed in the axial direction, between the circumferential flange 84 and the proximal surface of the indicator 80, the intermediate part of the U-bracket 81 is positioned. As can be seen in Figure 5, this intermediate part of the U-bracket 81 comprises a through hole through which the distal part of the indicator rod 82 extends. The two legs of the U-shaped arm 81 extend axially towards the proximal end of the plunger rod 60. At their proximal ends, the two legs of the U-bracket 81 each comprise a radial leg 86. These radial legs 86 protrude into the corresponding radial openings in the plunger driver 50 (see Figure 5). The. Figure 9 shows a perspective view of a second preferred embodiment of the present invention. The injection device 100 shown in Figure 9 is largely identical to the injection device 1 according to the first preferred embodiment of the present invention. The same components are marked with identical reference numerals. Hereafter, only the differences between the first and second preferred embodiments will be explained in detail.
[0095] As shown in Figure 9, the injection device 100 is different from the injection device 1 in relation to the indicator set that is provided to show the end of a 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.
[0096] The second preferred embodiment shown in Figure 9 comprises an indicator assembly 180 provided at the distal end of the housing. The indicator assembly comprises a lid that has at least one opening 181. In the embodiment shown in the drawings, two opposite openings / windows 181 are provided. Through these openings 181, the user can see a signaling element in the form of a rotating wheel or disk 182, which is also shown in Figure 10. The window is preferably placed at the transition between a lateral surface and a terminal surface. distal cover.
[0097] As shown in Figure 11, the rotating disk 182 comprises a proximal cylindrical protrusion 183, such as a wheel hub. Through this wheel hub 183, the rotating disk 182 is connected to the distal end of the plunger driver 50. Thus, when the plunger driver 50 is rotated by the first spring 40, the rotating disk 182 also rotates. This can be seen by the user through window 181. Thus, the user can easily see that the device works correctly and that an injection is in progress.
[0098] As also shown in Figure 11 and Figure 12, the rotating disk comprises a distal indicator structure that has a plurality of segments 184a, ..., 184i, ..., 184n. These segments 184 alternate with radial ribs 185. When the rotating disk 182 rotates, the structure of ribs and alternating segments passes window 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 includes a first indicator element, while segment 184 or rib 185 shown in the window at the final injection position probably comprises a different second indicator element for 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 of 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, in order to distinguish the initial position from the final position.
[0099] 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 penetrating the needle and drug injection shown in Figures 2 to 6 is also present in the injection device 200 of Figures 13 and 14.
[0100] The injection device 200 comprises an indicator assembly 280. Figure 14 shows an exploded view of the indicator assembly 280. The indicator assembly 280 comprises a distal indicator assembly cover 281 which is mounted on the proximal housing part 3, for example. example, by a snap or pressure coupling. On the distal surface being perpendicular to the longitudinal axis of the injection device 200, an opening or window 282 is provided.
[0101] Inside the indicator cover 281, a set of planetary gears 283 is positioned. The solar wheel 284 of the planetary gear is connected to the plunger driver 50 at the distal end thereof.
[0102] In addition, an indicator disk 286 is axially positioned between the planetary gear assembly 283 and the distal wall of the indicator cover 281. Indicator disk 286 comprises an indicator area 287. Indicator area 287 is distinguishable from the area of the remaining indicator disc 286, for example, by a different color or a different texture. In the initial position of the injection device 200, the indicator assembly 280 is positioned so that the indicator area 287 is positioned on one side of the window 282. In general terms, the window can have any type of crescent shape. Alternatively, it may be shaped like an L. In the case of a crescent shape, at one end of the window, the side faces of the window may contact each other (such as side 289), while the other end may be truncated (such as side 288). Therefore, the indicator assembly 280 can be positioned so that the indicator area 287 is positioned on the side of the window that has the greatest width (side 288). Thus, the user can see a large part of the indicator element through the window 282. During injection of the medicine, the indicator disk 286 rotates and, simultaneously, the indicator element 287 is rotated towards the other end of the indicator 282, that is, in towards the small end 289. Thus, the area of the indicator element 287 seen by the user is reduced, which shows the user the progress of the injection and also indicates the end of the dose to the user.
[0103] Figure 14 also shows indicator pin 285 which is also in coupling with planetary gear set 283. Such pin 285 can be optionally provided to have an additional signaling element on the outer surface of the distal housing part 5, as can be seen in Figure 13.
[0104] The second and third preferred embodiments comprise a rotary injection indicator mechanism 180, 280 to indicate the injection progress to the user. These rotary injection indicator mechanisms 180, 280 comprise a signaling element and a drive mechanism for rotationally driving said signaling element. The drive mechanisms are coupled to the plunger driver 50 at the distal end thereof. In addition, these rotary injection indicator mechanisms are positioned so that the progress of the injection is shown through at least one opening provided in at least one surface of the distal end of the housing.
[0105] Although the invention has been illustrated and described in detail in the drawings and in the previous description, such illustration and description should be considered illustrative or exemplary and not restrictive. It should be understood that changes and modifications can be made by those skilled in the art within the scope of the following claims. In particular, the present invention encompasses other embodiments with any combination of characteristics from the different embodiments described above and below.
[0106] Furthermore, in the claims, the word "comprising" does not exclude other elements or steps and the indefinite article "one" or "one" does not exclude a plurality. A single unit can perform the functions of several resources listed in the claims. The terms "essentially", "about", "approximately" and so on, in relation to an attribute or a value also define, in particular, 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 (19)
[0001]
1. Injection device comprising: a housing (2, 3, 4, 5), a container support (10), arranged axially in the longitudinal direction 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 watertight and sliding cap arranged inside said medicine container (12) at the other end of it, a plunger rod (60) disposed with a proximal end can be contacted by said plug, a first (40) and a second (45) energy accumulator element disposed inside the injection device housing (1, 100, 200) and adapted to accumulate and to store energy, means for driving the plunger (50, 70) being arranged slidable in relation to the plunger rod (60), being rotatively locked to the plunger rod (60) and being rotatable in relation to the housing (2, 3, 4 , 5), said means piston actuators (50, 70) are operatively associated with said first member of the energy accumulator (40), a container controller (32) connected to the container support (10) and screwed connected to the piston rod (60) said container controller (32) being connected to said second energy accumulator element (45) such that, due to an axial output force from said second energy accumulator element (45), the energy controller container (32), the container support (10) and the plunger rod (60) are axially movable with respect 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 in which a needle penetration is performed, the injection device characterized by the fact that it comprises a piston actuator locking means are arranged between the container trigger (32) and the piston actuating means (50, 70), providing a lock for the piston actuating means (50, 70) to be rotated in the initial locked position, and in which the piston actuator locking means, when the container is moved to the second position, the piston actuating means (50, 70) are released such that, due to an output torque from said first energy accumulator element (40), the actuating means the plunger (50, 70) are allowed to be rotated and the plunger (60) is propelled towards the proximal end of the injection device (1, 100, 200), so the injection is carried out.
[0002]
2. Injection device according to claim 1, characterized in that the injection device (1, 100, 200) further comprises a container controller locking means (25) that can be rotated relative to the housing ( 2, 3, 4, 5) and for the container conductor (32), and configured to hold the conductive container (32) in its initial locked position and to release said container driver (32) from its initial position locked towards the proximal end of the injection device (1, 100, 200) to the second position.
[0003]
Injection device according to claim 2, characterized by the fact that the 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 accommodation (2, 3, 4, 5).
[0004]
Injection device according to claim 3, characterized in that said first member of the energy accumulator (40) is a spring of constant force.
[0005]
Injection device according to any one of the preceding claims, characterized in that said second energy accumulator element (45) is disposed between said container conductor (32) and a projection on the inner surface of the housing (2, 3, 4, 5).
[0006]
6. Injection device according to any one of the preceding claims, characterized in that said injection device (1, 100, 200) further comprises a needle shield sleeve (17), arranged slidably in a proximal part of said housing (2, 3) and being able to act on said container controller locking means (25) when said needle shield sleeve (17) is pressed against an injection site.
[0007]
Injection device according to claim 6, characterized in that said needle shield sleeve (17) and said container actuator locking means (25) are operationally connected in such a way that the movement axial of said needle shield sleeve (17) to the distal end of the injection device causes said actuator locking means (25) to rotate.
[0008]
Injection device according to claim 7, characterized in that said rotational movement of said container controller locking means (25) results in a release of said container controller (32).
[0009]
Injection device according to any one of claims 6 to 8, characterized in that the injection device (1, 100, 200) further comprises resilient means for pressing said needle protection sleeve (17) into the direction of the proximal end of the injection device (1, 100, 200) when said injection device (1, 100, 200) is removed from the injection site.
[0010]
10. Injection device according to claim 9, characterized in that said injection device (1, 100, 200) further comprises a locking means (28) for locking said sleeve (needle guard ( 17) against movement to the distal end of the injection device (1, 100, 200) when said injection device (1, 100, 200) is removed from the injection site.
[0011]
Injection device according to claim 10, characterized by the fact that said needle protection sleeve locking means (28) is formed by said container actuation locking means (25).
[0012]
Injection device according to any one of claims 7 to 11, characterized in that said operational connection between said needle protection sleeve (17) and said container driver locking means (25) is formed by a camera - slot mechanism.
[0013]
13. Injection device according to any one of the preceding claims, characterized by the fact that the injection device (1, 100, 200) further comprises an injection indication mechanism (80, 180, 280) to indicate the user the progress of the injection.
[0014]
14. Injection device according to claim 13, characterized by the fact that the injection indication mechanism is an axial injection indication mechanism (80) to indicate to the user that the injection of medication has come to an end.
[0015]
15. Injection device according to claim 14, characterized by the fact that the axial injection indication mechanism (80) comprises a signaling element and a drive mechanism for axially driving said signaling member.
[0016]
16. Injection device according to claim 15, characterized by the fact that said drive mechanism is coupled to said piston drive means (50, 70).
[0017]
17. Injection device according to claim 15 or 16, characterized by the fact that said axial injection indication mechanism (80) is arranged in such a way that a visible and tactile signal signals to the end user of the injection.
[0018]
18. Injection device according to claim 15, 16 or 17, characterized by the fact that the signaling element has a pin that is moved distally from an initial position to an end position, in relation to the box as soon as the injection is finished.
[0019]
19. The injection device according to claim 18, characterized in that the surface of the distal end of the body comprises a through hole, the distal end of said pin protruding out of said through hole, in the final position of the said pin.

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AU2012269770B2|2015-04-16|

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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 61/498,541 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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2017-03-28| B11A| Dismissal acc. art.33 of ipl - examination not requested within 36 months of filing|

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2017-08-15| B04C| Request for examination: reinstatement - article 33, solely paragraph, of industrial property law|

---

2017-08-22| B12F| Appeal: other appeals|

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2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|

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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: suspension of the patent application procedure|

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2020-11-24| B09A| Decision: intention to grant|

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2020-12-29| 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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SE1150553|2011-06-17|

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SE1150553-4|2011-06-17|

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US201161498541P| true| 2011-06-18|2011-06-18|

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US61/498,541|2011-06-18|

---

PCT/SE2012/050614|WO2012173553A1|2011-06-17|2012-06-07|Injection device|

---