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  • 专利说明
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    • 专利摘要:
    DRUG RELEASE DEVICE UNDERSTANDING A LOCKING MECHANISM WITH A LEVER. Medication delivery device comprising a movable protector (10) between a proximal and a distal position and a locking mechanism (15) having a lever (16), the lever (16) limiting the movement of an actuating locking member (24) until the movable protector is positioned in a distal position and the lever (16) limiting the movement of the protector (10) in a proximal position after activation of the device.
    公开号:BR112013025628B1
    申请号:R112013025628-1
    申请日:2012-03-30
    公开日:2021-01-12
    发明作者:Anders Holmqvist
    申请人:Shl Medical Ag；
    IPC主号:
    专利说明:

    [0001] The present invention relates to a drug delivery device, for example, for injection, having a locking mechanism. More specifically, the present invention relates to a self-injecting drug delivery device having a mechanism to inhibit dose delivery until the device is positioned in a dose delivery location and / or to lock a protector in a proximal position. after release of a dose, the mechanism comprising a cam. RELATED TECHNIQUE
    [0002] Drug delivery devices for automatic or semi-automatic drug injection have been known for many years. Although the first generations of injectors aimed merely at releasing a drug as quickly as possible, the increased use of devices by patients in non-clinical settings has led to the need to provide additional handling and safety functions.
    [0003] Important handling and safety functions for drug delivery devices include inhibiting premature device activation (trigger failure). To ensure that the medication is properly injected, the device is not activated until the auto-injector is correctly positioned in a dose release location. In addition, since the drug-releasing member can be pointed and contaminated after the device has been activated, devices have been developed that retract or cover the drug-releasing member when the device is removed from the dose-releasing site. . To prevent a person from unintentionally putting the medication release member in contact and to allow safe disposal of the device, some devices have a mechanism that locks the device once the drug release member is covered or retracted.
    [0004] WO 02/047746 discloses a medicament delivery device comprising a compartment arranged to contain a medicament container, a needle cover surrounding a needle and elastic means. The elastic means can push the needle past the end of the needle cover and operate the medication container to deliver a dose of medication. In addition, the device comprises the first locking means which locks the elastic means in a pressurized state. The first locking means can be released by the first activation means, which can be manually operated. The first activation means are locked by the second locking means, which are released by the second activation means when the needle cover is exposed to pressure by the drug delivery device which is positioned at the dose delivery site. When the patient removes the injector from the dose delivery site, additional elastic means push the needle cover out of the compartment. A locking ring with arms that engage openings in the compartment is provided to prevent the needle cover from being pushed in again. Although the drug delivery device provides all the necessary functions, several mechanisms are necessary to achieve this goal.
    [0005] WO 2004/060445 discloses a safety system for a syringe. The system can forcibly inject a syringe when a trigger contacts the dose delivery site and removes the syringe in a compartment when the injection is complete. However, the needle and guard can be moved, allowing the needle to be contacted even after being retracted into the compartment. Therefore, WO 2004/060445 proposes the use of external covers for safe disposal of the system.
    [0006] WO 2006/118616, which relates to a needle-free injector device, discloses a mechanism for inhibiting the device from activating until the device is positioned against the skin. However, also in this case, the revealed mechanism is not designed to prevent users or third parties from unintentionally contacting the drug release member after the device is activated.
    [0007] As shown above, the available drug delivery devices do not provide the necessary handling and safety functions, nor do they require cooperation from one or more complex mechanisms. Therefore, some of the present devices are not safe, while others are expensive to produce and difficult to assemble. Therefore, there is a need for drug delivery devices that comprise mechanisms providing some or all of these functions with as few parts as possible and in a safe manner. SUMMARY OF THE INVENTION
    [0008] In order to overcome one or more of the problems mentioned above, drug delivery devices are provided in accordance with the independent claims.
    [0009] Additional aspects, improvements and variations are revealed in the dependent claims, figures and description.
    [0010] The drug delivery device of the present invention allows inhibiting the activation of the device until the device is positioned in a dose delivery location. In addition, a medication delivery device is provided in which the medication delivery member is covered securely after activation of the device. The device can thus be safely stored or disposed of. These advantages are achieved by providing a drug delivery device with an improved locking mechanism. The locking mechanism of the drug delivery device of the invention provides one or more of the functions in a safe and reliable manner and requires a minimum amount of elements. The locking mechanism is easy to assemble and the medication delivery device can be manufactured cost-effectively.
    [0011] In the present application, when the term "distal" is used, it refers to the direction that points away from the dose delivery site. When the term "distal end / part" is used, it refers to the part / end of the delivery device, or the parts / ends of the limbs thereof, which are / are located further away from the dose delivery site. Correspondingly, when the term "proximal" is used, it refers to the direction that points to the dose release location. When the term "proximal end / part" is used, it refers to the part / end of the delivery device, or to the parts / ends of the limbs of the same, which is / are located closest to the dose delivery site.
    [0012] According to independent claim 1, a drug delivery device is provided. The medication delivery device comprises a movable guard that is movable between a proximal and a distal position and a locking mechanism that has a lever. The lever limits or locks the movement of a drive locking member until the movable guard is positioned in a distal position and the limit lever or locks the movement of the guard in a proximal position after the device is actuated. Thus, both of these functions can be provided by a single locking mechanism, for example, a lever. The lever can be reciprocated.
    [0013] According to a further embodiment of the present invention, a drug delivery device for self-injection comprises a movable protector that is movable between a proximal and a distal position and a locking mechanism is provided which has a reciprocating. The shuttle limits movement of a drive locking member until the movable guard is positioned in a distal position and / or the shuttle limits the movement of the guard to a proximal position after the device is actuated. Any feature described below can also be provided with that embodiment of the invention. In particular, any feature relating to the lever can also be provided for the shuttle.
    [0014] The lever or shuttle can be pivotally mounted to any member of the medication delivery device. Preferably, the lever or shuttle is formed integrally and articulated with any member of the device. More preferably, the lever or shuttle is integrally formed with a medicine container holder. The lever or shuttle is preferably provided in such a way that it can be pivoted or flexed around its main axis in both directions.
    [0015] In the context of the present invention, the term "protector" indicates a member to cover a drug-releasing member. The protector is preferably contacted when the device is positioned at the dose delivery site. In addition, the protector preferably covers the member of the drug delivery device when the device is removed from the dose delivery site at least after the device has been activated. Preferably, after activation of the device, the protector is moved and locked in a position that covers the drug-releasing member. Consequently, the protector according to the invention is movable or movable. Most preferably, after the device has been activated, the protector is moved and locked in a proximal position when the device is removed from the dose delivery site. The protector is preferably induced in a proximal direction by the force of a spring. The spring can be provided at the proximal end of the protector. The spring can be formed integrally with the protector. In this way, the protector is a protective element, such as a needle protection element or needle protection glove, which protects the user against accidental or accidental contact with the needle, which may be contaminated.
    [0016] A drug release member can be any member through which a drug is released. For example, the drug-releasing member can be a needle or cannula, for example, a needle-free injection cannula. The medicament-releasing member can be integrally formed with a medicament container or it can be an element independent of the device. Preferably, the drug release member is covered or retracted until the drug release device is activated and cannot be contacted unintentionally until that time. For example, the medication delivery member can be retracted in the medication delivery device.
    [0017] According to any embodiment of the present invention, the medication delivery device can comprise a drive mechanism and / or a drive locking member. A trigger mechanism is a mechanism that drives the device to deliver a dose. Preferably, the drive mechanism drives the device by releasing the resilient means from a pressurized state, the resilient means being able to push the medicament-releasing member beyond the end of the needle cover and / or operate a medicament container for provide a dose of medicine. Preferably, the drive mechanism triggers the device when activated by a user. The drive mechanism is preferably activated when the user presses a command button. The command button may be located at the distal end of the device. In one example, the control button is able to be pressed in a longitudinal direction of the drug delivery device. In another example, the control button is first able to rotate around the longitudinal axis of the drug delivery device and, subsequently, pressure operated in the longitudinal direction of the drug delivery device. Instead of being in the shape of a button, it can be shaped like a glove. In another example, the control button is capable of being actuated across the longitudinal axis of the medication delivery device. Instead of a push button, a rotary knob can be used.
    [0018] In any embodiment of the present invention, the drive mechanism, preferably, can only be activated when certain conditions are met. Preferably, the drive mechanism is locked and cannot be activated until the device is positioned in a dose release location. For this purpose, the device may comprise a drive locking member that locks the drive of the device. The drive locking member can lock the drive of the device by locking the drive mechanism and / or by locking another member and thereby inhibit the drive mechanism from being activated (for example, unintentionally). Preferably, the actuation locking member locks the actuation of the device by limiting the movement of a member or part of the actuation mechanism or the entire actuation member. For example, the drive locking member may have distally directed arms adjacent to the projections of a member of the drive mechanism.
    [0019] When the actuation locking member limits the movement of a member or part of the actuation mechanism, the actuation mechanism can be locked by restricting the movement of the actuation locking member. In any embodiment of the present invention, the drive mechanism and / or the drive locking member can be provided such that the drive of the drug delivery device is inhibited until the device is positioned at the dose delivery site. Preferably, the activation of the device is inhibited until a protector, for example, a needle protection glove, which contacts the dose delivery site is moved or displaced and reaches a distal position.
    [0020] According to any embodiment of the invention, the drive mechanism may comprise a drug delivery drive unit for expelling the drug from the drug delivery device. The drive unit may include a plunger member. At least one spring for spring loaded the plunger member can be provided around the plunger member or in a hollow space thereof. The plunger member can be spring loaded by the spring to be compressed or stretched.
    [0021] The medication delivery drive unit may further comprise an actuation spring support for retaining the elongated or compressed spring. The drive spring support can be configured to partially surround the spring loaded plunger member. Preferably, the actuating spring support is generally U-shaped and has at least one, preferably two, proximally oriented legs. Each leg may comprise an outwardly extending radial shoulder.
    [0022] The medication delivery drive unit may further comprise connection means for retaining the spring loaded plunger member in a preloaded state. For this purpose, the connection means can be arranged with a distally oriented arm, which can be flexible in the radial direction. Preferably, the distal end of the arms is arranged with an inwardly oriented hook. The hook can be configured to fit at least one notch of the plunger member or a plunger rod. Preferably, two distally oriented arms are provided, each having an inwardly oriented hook. Preferably, the drive spring support is axially disposed through the connection means.
    [0023] In addition, the drive mechanism may comprise at least one member of the drive mechanism for releasing the connecting means from the spring loaded piston member or the piston rod. The member can be coaxially slidable over the connection means.
    [0024] Preferably, the actuation spring is compressed between a surface of the proximal inner end of the plunger member and the actuation spring support when the medication delivery actuation unit is mounted. More preferably, the actuation spring is compressed between a surface of the proximal inner end of the plunger member and a transverse contact end of the actuation spring support. The radial projections extending out of the actuation spring support can be engaged with the proximal annular surface of the connection means to prevent the actuation spring support from being moved in the distal direction by the spring. The drive mechanism member can be arranged around the distally oriented arms of the connecting means, such that the arm hooks are engaged in a corresponding engagement with a notch in the piston member. Starting position
    [0025] According to any embodiment of the present invention, the movement of the actuating locking member can be limited by a locking mechanism or a lever at least in a certain direction, preferably the proximal direction. Preferably, the movement of the actuating locking member is limited when the lever is in an initial position. The starting position is preferably the first position in a dose release cycle. Most preferably, the starting position is a position in which the device is ready to be used, however the drive mechanism may not be activated. The starting position can be a position in which no force or substantially no force acts on the lever and / or in which the lever is not overlapped by members that can overlap the lever.
    [0026] For the purpose of limiting the movement of the actuating locking member, the lever can be of any suitable shape. Preferably, the lever comprises at least a first portion and at least a second portion, the second portion being positioned further away from a plane that is parallel to the longitudinal axis of the drug delivery device and includes the main axis around which the lever rotates than the first portion when the lever is in the home position. Assuming a generally elongated or cylindrical shape of the medication delivery device, said plane is a plane tangential to the external surface of the medication delivery device, that is, its compartment, or parallel to said tangential plane. The second portion is raised or projected in relation to said plane. For example, the lever can be curved or articulated. More preferably, the lever comprises a second portion that is thicker than a first portion. More preferably, the lever comprises a second portion having a shoulder. The main axis of the lever can be considered as a limit line or boundary between the first portion (which is proximal to that line) and the second portion (which is distal to the line).
    [0027] According to any embodiment of the invention, it is preferred that the movement of the actuation locking member towards or to the position that releases the actuation mechanism is limited by the actuation locking member adjacent to the lever when the lever is in the initial position. Preferably, the actuating locking member abuts at least a part of the second portion of the lever. More preferably, the movement of the drive locking member is limited because the drive locking member leans against one of the lever portions which is thicker than the others. More preferably, the movement of the actuation locking member is limited by the actuation locking member that abuts the shoulder of the lever. In this way, the lever provides a locking function that locks the actuation locking member in its initial position.
    [0028] In any embodiment of the invention, the actuating locking member is preferably provided away from the lever. Therefore, it is preferred that at least a part of the lever portion against which the actuating locking member abuts is provided at or near the distal end of the lever. Preferably, at least a portion of the second portion of the lever is provided away from at least a portion of the first portion of the lever, the second portion being positioned further away from the plane which is generally parallel to the longitudinal axis of the drug delivery device and including the pivot axis around which the lever rotates with respect to the first portion when the lever is in the home position, as defined above. More preferably, at least a part of the second portion is provided away from the pivoting axis of the lever and at least a part of the first portion is provided close to the pivoting axis of the lever. The rotary axis is preferably perpendicular to the longitudinal axis of the drug delivery device, while being displaced from the longitudinal axis. Assuming a generally cylindrical or elongated shape of the medication delivery device, the rotating axis can be tangential to the outer surface of the medication delivery device, that is, its compartment, or parallel to said tangential.
    [0029] According to any embodiment of the invention, the guard can preferably be moved in at least one direction when the lever is in the home position. Preferably, the guard can be moved in the distal direction. More preferably, the guard is moved in the distal direction when the drug delivery device is pressed against the dose delivery site. Most preferably, the protector reaches a distal position when the drug delivery device is correctly positioned at the dose delivery site. The guard is preferably moved in the distal direction against the force of a spring. The spring can be provided at the distal end. The spring can be integrated with the protector. Tensed position
    [0030] When the guard moves, preferably when the guard is moved or moved in a distal direction, the guard or a member moved by the guard preferably overlaps at least a portion of the lever. Preferably, the guard or the member moved by the guard first overlaps at least part of a first portion of the lever and subsequently overlaps at least part of a second portion of the lever, the first portion being positioned closest to the plane which is generally parallel to the plane. longitudinal axis of the drug delivery device and includes the rotary axis on which the lever rotates, than the second portion when the lever is in the initial position, as defined above. Preferably, the protector or the limb moved by the protector overlaps at least part of the first portion which is provided close to the second portion. More preferably, the guard or the member moved by the guard first overlaps a proximal portion of the lever and subsequently overlaps a distal portion of the lever. More preferably, the guard or the member moved by the guard first overlaps at least a part of the first portion which is provided close to the rotating axis of the lever and subsequently overlaps at least a part of the second portion, which is positioned away from the rotating axis of the lever. Preferably, the lever is in the general shape of a beam with a first and a second portion, the first portion being thinner than the second portion. When the guard or a member moved by the guard moves in a distal direction, preferably at least part of the thinnest portion that is provided close to the rotating axis of the lever is superimposed first. Preferably, the protector slides over the lever, like a glove. More preferably, the protector can slide over the second portion, the thickest portion or the shoulder of the lever, because that portion and / or the portion of the protector or the member moved by the protector that comes into contact with that portion is wedge-shaped .
    [0031] Since the proximal portion of the lever is overlapped by the guard, the lever cannot rotate when a force is exerted on the distal end, for example, by tongues that exert a force on the distal end of the lever when they overlap the shoulder and press the distal end inward. In this way, the lever, preferably in the form of a beam, will be tensioned due to the position of the protector.
    [0032] Such a beam can be connected in the middle of it to a medicine container support by two articulation arms, so that a proximal end and a distal end of the beam are defined. The beam can be formed integrated with the medication release container or swiveled with it. The distal end of the beam can be arranged with a shoulder that extends transversely over both sides of the beam. The protector can be arranged in such a way in relation to the beam that the tabs are positioned on each side of the beam.
    [0033] When the guard overlaps the lever in the manner described, the guard preferably exerts a force on the distal portion of the lever and / or tensions the lever. In response, the lever - being sufficiently flexible - is preferably curved or flexed in such a way that it no longer touches the drive locking member. The lever preferably no longer touches the actuating locking member when the guard reaches a distal position. The protector preferably reaches the distal position when the drug delivery device is correctly positioned at the dose delivery site. The distal position is preferably in a position in which the protector is positioned in such a way that the drug-releasing member can deliver a dose if the drug-releasing device is activated.
    [0034] When the lever no longer touches the actuation locking member because it is bent or flexed or articulated, the actuation locking member can preferably move at least in a certain direction in which the lever limits movement as long as it rests against the actuation locking member . Preferably, the drive locking member can be moved in a proximal direction. When the movement of the actuating locking member is not limited at least in a certain direction, preferably the proximal direction, the medication delivery device can be preferably actuated. More preferably, the device can be activated by activating the drive mechanism.
    [0035] When the drive locking member can be moved in a proximal direction, preferably a member of the drive mechanism can also move. When moving, the drive mechanism member preferably slides along the arms of the connecting means such that at least one arm of the connecting means is free to move through at least one recess of the driving mechanism member in one radial direction. This preferably causes the hooks of the connection means to move out of contact or their elastic engagement with the notches of the spring loaded piston member or the spring driven piston rod. This preferably releases the spring loaded plunger member or the spring loaded plunger rod to move in the proximal direction due to the compressed spring force of the drug delivery drive unit. The movement of the spring loaded plunger member or the spring loaded plunger can then force the stop to move proximally and thus expel the drug through the drug release member. The medication delivery operation can be completed when the stop has reached its final position, for example, the position of the proximal end within the medication container. The arms of the connection medium can be configured in such a way that the push button is locked in a proximal position and pressed when the device has been activated. For example, the member of the drive mechanism may have at least one recess through which at least one arm of the connecting means extends and engages the push button.
    [0036] When the guard is moved, preferably when the guard is moved to the distal position, the guard or the member moved by the guard preferably contacts and / or overlaps certain portions of the lever, but does not contact and / or overlap the entire lever. In particular, the protector preferably does not contact and / or overlap the entire second portion of the lever. The protector may have tongues and / or distally extended portions of different radial thickness. Preferably, the guard has two tabs extended distally. The tabs can be attached to or made integrated with the distal end of the protector. For example, the tongues extend in a longitudinal direction to the distal end of the device like the legs of a U. The lever can be shaped like a beam with a proximal end and a distal end. Preferably, at least a part of the second portion of the lever is provided at or near the distal end of the lever. More preferably, the lever is thicker at or near the distal end, and more preferably, the lever has a transversely extending shoulder, positioned at or near the distal end. The shoulder may extend transversely (in relation to the longitudinal axis of the beam or the medication delivery device) to both sides of the beam.
    [0037] According to any embodiment of the present invention, the lever can also be overlapped by a member upon activation of the device. Preferably, the lever is superimposed by the actuating locking member. More preferably, the lever is overlaid by the actuating locking member which moves in a direction in which the lever limits its movement when it is in the starting position. More preferably, the lever is overlaid by the actuating locking member which moves in the proximal direction.
    [0038] The member that overlaps the lever when the device is operated preferably overlaps at least a part of the second portion of the lever. More preferably, the member overlaps at least one part, but not the entire second portion of the lever. More preferably, the member overlaps and / or contacts a part of the second portion of the lever, which is not overlapped by the guard or by a member moved by the guard when the guard is in the distal position. The member that overlaps the lever after actuation of the device, preferably the actuation locking member, may have one or more longitudinally extending tongues and / or portions of different radial thickness. Preferably, the proximal portion of the drive locking member is ring-shaped (such as a glove-like structure) or a ring-shaped member, allowing the drive locking member to slide along the medicine container holder . Preferably, one or more tabs or extensions extending longitudinally in a proximal direction are provided at the proximal end of the actuating locking member. The tabs can be attached to or made in an integrated manner with the proximal end of the drive locking member. Most preferably, a tongue is provided. Alternatively, two tongues or three tongues are provided. The actuating locking member is preferably adapted to overlap and / or contact other parts of the lever in addition to those contacted by the guard or a member moved by the guard. More preferably, the tabs that extend longitudinally from the actuation locking member and the guard are adapted to the actuation locking member and the guard or a guard-moved member to be cut between each other. Viewed in the circumferential direction of the medication delivery device, the tongues of the actuating locking member have a space or gap between them, and the protector tongues are also spaced apart by a gap. In relation to each other, the tongues of the actuating locking member are in circumferential positions corresponding to the circumferential positions of the clearances between the protector tongues, so that the tongues extend to the corresponding clearances.
    [0039] In other words, the ring-shaped part or member of the drive locking member may have at least one tongue that extends closely arranged in line with the beam of the locking mechanism. The ring-shaped member can additionally be arranged with distally oriented arms. The distal parts of the arms can extend into the longitudinal grooves of a guide sleeve on the drive mechanism. At the distal end of these longitudinal grooves, transverse grooves can be arranged. An additional member of the drive mechanism can be provided inside the guide sleeve. The member may comprise a generally tubular proximal part arranged with projections on its outer surface, these projections engaging the grooves of the guide sleeve. In addition, the tubular part of the member can extend in the distal direction to a push button, which protrudes through an opening at the distal end of the device.
    [0040] In this way, when the lever or beam of the locking mechanism is in the initial position, the push button cannot be pressed because the tongue proximally directed to the actuating locking member touches the beam shoulder and is limited to move. in the proximal direction. Once the distal ends of the arms are placed in the longitudinal grooves, they are on the way to the protrusions. In this way, the drive mechanism cannot be activated and the device is locked against activation.
    [0041] According to any embodiment of the present invention, the lever can be released from tensioning when the guard or a member moved by the guard moves in a proximal direction. Preferably, the lever is released from tension when the guard moves to a proximal position. The proximal position is preferably a position in which the protector covers the medication-releasing member, but no longer overlaps the lever. Preferably, the protector or the limb moved by the protector moves in a proximal direction by a spring arranged to induce the protector in the proximal direction. The spring preferably induces the protector in a proximal direction when the drug delivery device is removed from the dose delivery site. When the lever is overlapped by an additional member while it is tensioned, preferably when the lever is overlapped by the actuation locking member while it is tensioned, releasing the tensioning of the lever can cause the lever to be positioned in a final position. Final position
    [0042] According to any embodiment of the invention, the movement of the guard may be limited by the lever in at least a certain direction, preferably the distal direction. More preferably, the movement of the guard in the distal direction is limited when the guard reaches a proximal position after the device has been operated. Preferably, the lever limits the movement of the guard when the lever is in the final position. The final position is preferably the last position of the lever in a dose release cycle. Most preferably, the final position is a position in which the device has been activated and a dose has been delivered. Preferably, the final position is a position in which the actuating locking member overlaps and / or contacts the lever at least partially. More preferably, the final position is a position in which the actuating locking member overlaps and / or contacts the distal portion of the lever at least partially. More preferably, the final position is a position in which the actuating locking member overlaps the second portion of the lever at least partially. Even more preferably, the final position is a position in which the actuating locking member overlaps and / or contacts at least partially a portion of the lever against which it abuts in the initial position. The final position can be a position in which the lever is rotated in response to a force on the distal portion of the lever and / or a position that is reached when the lever is released from tension.
    [0043] When the lever is in the final position, the movement of the guard is preferably limited by the guard or a member moved by the guard that leans against at least a portion of the lever. Preferably, the protector leans against a proximal portion (the first portion) of the lever. More preferably, the protector leans against a proximal end of the lever. In the final position, the guard preferably leans against a portion of the lever that it overlaps when the lever is tensioned.
    [0044] In this way, the proximal movement of the spring will cause it to release the proximal end of the beam, whereby the latter will flex outwards in the radial direction due to the accumulated tension in the beam. The lever, preferably a beam, can thus reach the final position in which the lever limits the movement of the protector in the distal direction. The proximal end of the longitudinal beam can be positioned between the protector's distally directed tongues, locking the protector against movement in the distal direction and allowing the device to be safely disposed of.
    [0045] According to any embodiment of the invention, the actuating locking member preferably touches the lever when the lever is in the initial position and is slidable over the lever when the lever is tensioned. In addition, also according to any embodiment of the invention, the guard is preferably slidable on the lever when the lever is in the initial position and abuts against one of the lever portions when the lever is in the final position.
    [0046] The locking mechanism and / or the medication delivery device can be configured in such a way that the protector can be unlocked to start a new release cycle. Preferably, the drug delivery device is configured as a single-use disposable device and the protector cannot be unlocked without the device being destroyed or dismantled.
    [0047] The drug delivery device can be additionally arranged with a technical feature to indicate and, thus, inform the user when a dose release operation is completed. The technical feature can be arranged to generate an audible signal in response to a signal indicative of the completed release operation. For this purpose, at the end of the drug delivery sequence, the distal end of the spring loaded plunger member or the spring loaded plunger rod can pass out of the proximal end of at least one arm of the actuation spring support. In this way, the arm and shoulder of the actuation spring support can be free to move radially inward. Due to the remaining spring force of the medication release drive unit acting on the drive spring support, the latter can be moved in the distal direction until the drive spring support contacts a surface of the inner distal end of the medium of connection. When the spring support contacts the end surface, an audible signal can be produced, indicating to the user that the device can be removed from the release site and safely disposed of.
    [0048] The lever of any of the described embodiments can be a shuttle. BRIEF DESCRIPTION OF THE DRAWINGS
    [0049] The following figures below show an embodiment of the invention for purposes of illustration only. In particular, the disclosure in the figures is not intended to limit the protection range of the invention. The embodiment shown can be modified in many respects within the scope of the claims. Figure 1: expanded view of the drug delivery device of the present invention. Figure 2: locking mechanism of a drug delivery device of the present invention, the lever being shown in the initial position. Figure 3: enlarged view of the locking mechanism, the lever being shown in the initial position; Figure 4: locking mechanism of a medication delivery device of the present invention, the lever being tensioned and overlapped by the protector. Figure 5: locking mechanism of the medication delivery device of the present invention, the lever being overlapped by the guard and the actuation locking member. Figure 6: locking mechanism of the drug delivery device of the present invention, the lever being in the final position. DETAILED DESCRIPTION OF THE DRAWINGS
    [0050] Figure 1 shows an expanded view of a drug delivery device according to the present invention. The device comprises a protector 10 or glove-like structure sliding in the longitudinal direction within a generally cylindrical compartment 11. A spring 13 can be arranged to propel the protector 10 in the proximal direction.
    [0051] The protector 10 can comprise at least one distally directed tongue or it can have portions of different radial thicknesses fixed on or integrated with the distal end of the protector 10. For example, as shown in Figure 2, the protector 10 can comprise at least two distals directed 12 integrated with the distal end of the protector 10. A medication container holder 14 for holding a medicament container 70 can be arranged in the protector 10. The medicament container can comprise a medication delivery member. However, the medication release member does not have to be part of the medication container and can be a device-independent element. As shown in Figure 1, the drug-releasing member can be a needle 71.
    [0052] A side surface of the medicine container support 14 can be arranged with a locking mechanism 15. The locking mechanism 15 comprises a lever. The lever can be a shuttle. The lever can be in the form of a longitudinally extending beam 16. The beam 16 can be connected in the middle of it to the medicine container support 14 by two articulated arms 18, creating a proximal end 19 and a distal end 20. A beam can be integrated with the medication release container 14 or articulated with it. The distal end 20 of the beam 16 can be arranged with a shoulder extending transversely 22 on both sides of the beam 16. The guard 10 can be arranged in such a way with respect to the beam 16 that the tabs 12 are positioned on each side of the beam. beam 16, as will be further explained below.
    [0053] In addition, the device may be provided with an actuation locking member 24. The actuation locking member 24 may comprise a generally ring-shaped or glove-shaped member 26 surrounding the medicament container holder 14 and distally positioned in relation to beam 16. The ring-shaped member 26 can have at least one proximally extending tongue 28 arranged in line with the beam 16. The ring-shaped member 26 can still be arranged with distally directed arms 30 As shown in Figure 2, the distal parts of the arms 30 can extend into longitudinal grooves 32 of a guide sleeve 34. A member 38 of a drive mechanism 37 can be provided within the guide sleeve 34. The member 38 may comprise a generally tubular proximal portion arranged with projections 40 on its outer surface, projections 40 which fit into the groove 32 of the guide sleeve 34. In addition, the tubular portion of the member 38 may and extend in the distal direction, forming a push button 42, which protrudes through an opening at the distal end of the guide sleeve 34.
    [0054] The drive mechanism 37 may further comprise a drug delivery drive unit 50, which has a plunger member or an elongated plunger rod (not shown). The plunger member can be provided with a hollow space within which a drive spring 52 is arranged to spring loaded the plunger. The proximal end of the elongated plunger rod may be in contact with a stop of the medicament container 70. The medicament delivery drive unit may further comprise an actuation spring 52 that acts on the plunger rod. A distal end of the spring may be in contact with a drive spring support 54 having, in general, a U-shape.
    [0055] The drive spring support 54 may have legs distally directed and each leg may comprise an outwardly extending radial shoulder. The drive spring support 54 can be configured to partially surround the spring loaded plunger member.
    [0056] The medication delivery drive unit may further comprise connection means 56. Connection means 56 may be arranged with two distally directed arms 58, which may be flexible in the radial direction. The distal ends of the arms 58 can be arranged with hooks oriented inwardly 60. The hooks 60 can be designed to fit into the grooves of the piston rod to hold it in position, as will be explained. The drive spring support 54 can be axially disposed by the connection means 56. The member 38 can be coaxially slidable over the connection means 56.
    [0057] When the drug delivery drive unit is mounted, the spring 52 can be compressed between a surface of the proximal inner end of the plunger member and a transverse contact end of the drive spring support 54. The radial shoulders extended out of the spring drive bracket 54 can be engaged with the proximal annular surface of the connecting means 56 to prevent the drive spring bracket from being moved in the distal direction by the drive spring. The member 38 can be arranged around said distally directed arms 58, such that the hooks 60 are engaged in a corresponding engagement with a notch in the spring loaded piston member.
    [0058] As shown in Figure 2, when the lever of the locking mechanism 15 is in the initial position, the push button 42 cannot be pressed because the proximally directed tongue 28 of the driving locking member 24 abuts against the shoulder 22 of the beam 16 and it is limited to moving in the proximal direction. Once the distal ends of the arms 30 are positioned in the longitudinal grooves 32, they are on the way to the projections 40. In this way, the member 38 cannot be activated and the device is locked against activation.
    [0059] The next step is to perform a dose release. This is done by compressing the proximal end of the protector 10 against a dose delivery site. This causes the protector 10 to slide in the distal direction of the device, whereby the distally directed tongues 12 will be moved in contact with the shoulder 22. Since the shoulder 22 has a wedge shape, the fingers 12 will slide over the boss 22. Alternatively, only the tabs 12 or boss 22 and tabs 12 can also be wedge-shaped. As shown in Figure 4, protector 10 will overlap the shoulder 22 when it reaches a distal position, exerting a force on the shoulder 22 and thus at the distal end 20 of beam 16. For example, protector 10 can press the shoulder 22 inside. As is most visible in Figure 3, the medication container support 14 can be provided with a notch for this purpose.
    [0060] As shown in Figure 4, protector 10 can be configured in such a way that it also overlaps a proximal portion of the lever, preferably in such a way that it also overlaps the proximal end 19 of beam 16. For example, the protector can be positioned radially outside from the proximal end 19 of beam 16. Since the proximal portion of the lever is overlapped by the guard, the lever cannot rotate when a force is exerted at the distal end, for example, by the tongues 12 which exert a force at the distal end 20 of the lever when they overlap the boss 22 and press the distal end 20 inward. In this way, the lever, preferably beam 16, will be tensioned due to the position of the protector 10.
    [0061] When the shoulder 22 has been moved radially inward, as shown in Figure 3, the proximally directed tongue 28 of the drive locking member 24 does not touch the shoulder. The drive locking member 24 is free to be moved in the proximal direction. In this way, a dose of medication can be released by the pressure button 42 which is pressed in the proximal direction, whereby the projections 40 will push the arms 30 and thus the ring-shaped member 26 in the proximal direction, Figure 4 This movement of the push button can cause an activation of the medication release drive unit, such that the shoulders 60 of the arms 58 are moved out of contact with the plunger rod. Thus, the plunger rod can be forced in the proximal direction by the spring 52 and can act on the stop within the drug container 70 to deliver a dose of drug through the drug release member at the dose release site. The proximal movement of the ring-shaped member 26 causes its proximally directed tongue 28 to move in the proximal direction, whereby it can be moved over the shoulder 22, since the latter is pressed inwards in the radial direction. The actuation locking means (not shown) can be arranged to lock the member 38 and, thus, the push button 42 in the pressed and proximal position.
    [0062] When executing the release, the proximal movement of the member 38 causes it to slide along the arms 58. The arms 58 can then be free to move in the radial direction outwards through a recess 39 in the member 38, making with the hooks 60 moving out of contact of their elastic engagement with the notches of the spring loaded piston member. This, in turn, releases the spring loaded plunger member to move in the proximal direction due to the force of the compressed drive spring 52. The movement of the spring loaded plunger rod forces the stop to move proximally and, in this way, expel the drug through the drug release member. When the stop has reached its final position, that is, the position of the proximal end, within the medication container, the medication delivery operation is completed. The connection of the arms 58 through the recess 39 can provide that the member 38 and thus the push button 42 are locked in a proximal and pressed position.
    [0063] When the dose has been delivered, the device can be removed from the dose delivery site. This, in turn, can cause the protector 10 to be moved in the proximal direction by the spring 13. The proximal movement of the spring 13 will cause it to release the proximal end 19 of the beam 16, whereby the latter will flex to out in the radial direction due to the tension caused in the beam 16. The lever, preferably beam 16, can thus reach the final position shown in Figure 5, in which the lever limits the movement of the protector 10 in the distal direction. The proximal end 19 of the longitudinal beam 16 can be positioned between the distally directed tongues 12 of the guard 10, locking the guard 10 against movement in the distal direction and allowing the device to be safely disposed of.
    [0064] 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 in the scope of the following claims. In particular, the present invention covers additional embodiments with any combination of features of different embodiments described above and below.
    [0065] 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 serve the functions of several characteristics mentioned in the claims. The terms "essentially", "approximately", "about" and the like with respect to an attribute or a value particularly also define exactly the attribute or exactly the value, respectively. Any reference signs in the claims should not be construed as limiting the scope.
    权利要求:
    Claims (13)
    [0001]
    Injection drug delivery device comprising: a) a medicine container holder (14) for holding a medicine container (70) and comprising a medicine delivery member; b) a movable protector (10) to cover a medication release member, said movable protector (10) being slidable along the support of the medication container between a proximal position and a distal position, where proximal is pointing to a dose and distal release site is pointing away from the dose release site; c) a drive locking member (24) disposed on the opposite side of the protector (10) movable in relation to the medicine container support (14) and being slidable along the medicine container support, the protector (10) and the drive locking member (24) having at least one longitudinally extending tongue (12, 28); characterized by the fact that the medication delivery device still comprises a locking mechanism (15) that has a flexible lever (16), which is pivotally mounted on the support of the medication container (14) and comprises a first portion (19 ) being proximal to the rotating axis of the lever (16) and a second portion (22) being distal to the rotating axis of the lever (16), wherein the second portion (22) has a shoulder which is arranged to touch the longitudinally extending tongue (28) of the drive locking member (24) to limit the movement of the drive locking member (24) until the movable guard is positioned in the distal position, and being overlapped by the longitudinally extending tongue (12) of the movable guard (10) with lever tensioning and, allowing the actuating locking member (24) to move in the proximal direction for actuation device when the movable guard is positioned in the distal position, and where the first portion (19) is arranged to touch the movable protector (10) to limit the movement of the protector (10) in a distal direction after the device has been activated, the movable protector (10) has been moved in the proximal direction by a spring force, and the longitudinally extending tongue (28) overlaps at least part of the second portion of the lever.
    [0002]
    Device for releasing medication for injection, according to claim 1, characterized in that the first portion (19) is positioned closer than the second portion (22) to a plane that is generally parallel to the longitudinal axis of the device of drug release.
    [0003]
    Device for releasing medication for injection according to claim 2, characterized in that at least part of the first portion (19) and at least part of the second portion (22) are overlapped by the protector (10) or a limb moved by the guard (10) when the guard (10) is moved in a distal direction.
    [0004]
    Device for releasing medication for injection according to any one of claims 1 to 3, characterized in that the lever (16) is placed in a tensioned state by the guard (10) or by a member moved by the guard (10) when the guard (10) is moved in a distal direction.
    [0005]
    Device for releasing medication for injection, according to claim 4, characterized by the fact that the tensioning of the lever (16) unlocks the actuation locking member (24).
    [0006]
    Medication delivery device for injection according to any one of claims 1 to 5, characterized in that the lever (16) is at least partially overlapped by the actuation locking member (24) when the device is actuated.
    [0007]
    Device for releasing medication for injection, according to claim 4 or 5, characterized by the fact that the lever (16) is released from tensioning when the protector (10) or a limb moved by the protector (10) is moved in a proximal direction.
    [0008]
    Device for releasing medication for injection, according to claim 4, 5 or 7, characterized by the fact that the lever (16) limits the movement of the protector (10) in a distal direction when released from tensioning.
    [0009]
    Device for releasing medication for injection according to any one of claims 1 to 8, characterized in that the lever (16) has the T-shape or the H-shape or the U-shape or has the general shape of a beam that extends longitudinally.
    [0010]
    Device for releasing medication for injection according to any one of claims 1 to 9, characterized by the fact that each of the protector (10) or a member moved by the protector (10) and the actuating locking member (24) are capable of coming into contact with certain portions, but not with the entire lever (16).
    [0011]
    Device for releasing medication for injection according to any one of claims 1 to 10, characterized in that the lever (16) is integrated with the medication container support (14).
    [0012]
    Device for releasing medication for injection according to any one of claims 1 to 11, characterized in that the lever (16) limits the movement of the protector (10) when turning in response to a force on the second portion (22 ) of the lever (16) and / or where the lever (16) limits the movement of the actuating locking member (24) when substantially no force acts on the lever (16).
    [0013]
    Device for releasing medication for injection according to any one of claims 1 to 12, characterized in that the lever (16) is a shuttle.
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    同族专利:
    公开号 | 公开日
    KR101544662B1|2015-08-17|
    AU2012240635B2|2015-03-26|
    TW201302259A|2013-01-16|
    ZA201307440B|2014-11-26|
    JP2014514066A|2014-06-19|
    PL2694141T3|2020-11-02|
    EP2694141A4|2015-09-02|
    RU2560904C2|2015-08-20|
    EP2694141A1|2014-02-12|
    CN103717248A|2014-04-09|
    CA2832033C|2016-02-09|
    US10653849B2|2020-05-19|
    IL228728D0|2013-12-31|
    US20200101235A1|2020-04-02|
    KR20130138835A|2013-12-19|
    EP2694141B1|2020-05-13|
    JP5922760B2|2016-05-24|
    TWI490005B|2015-07-01|
    CA2832033A1|2012-10-11|
    WO2012138285A1|2012-10-11|
    US20170252518A1|2017-09-07|
    BR112013025628A2|2016-12-27|
    US9737668B2|2017-08-22|
    IL228728A|2017-06-29|
    RU2013149004A|2015-05-10|
    AU2012240635A1|2013-10-24|
    US20140018744A1|2014-01-16|
    CN103717248B|2016-08-17|
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    法律状态:
    2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-10-15| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2019-11-19| B25A| Requested transfer of rights approved|Owner name: SHL MEDICAL AG (CH) |
    2020-08-11| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|
    2020-11-24| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-01-12| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 30/03/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201161471886P| true| 2011-04-05|2011-04-05|
    US61/471,886|2011-04-05|
    SE1150300-0|2011-04-05|
    SE1150300|2011-04-05|
    PCT/SE2012/050355|WO2012138285A1|2011-04-05|2012-03-30|Medicament delivery device comprising a locking mechanism having a lever|
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