• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    AUTOMATIC INJECTION TRAINING DEVICE. Automatic injection training device with a housing assembly comprising an external housing, an actuation assembly, and a damping unit comprising a damping housing and a piston assembly which is arranged in said damping housing. The damping housing slides in a proximal direction with respect to the piston assembly when an injection is simulated.
    公开号:BR112015008015B1
    申请号:R112015008015-4
    申请日:2013-10-08
    公开日:2020-10-13
    发明作者:Oscar Alexandersson
    申请人:Shl Medical Ag；
    IPC主号:
    专利说明:

    Technical Field
    [0001] The present invention relates to automatic injection training devices, that is, mannequins or educational equipment to train individuals in administering medication by means of automatic injection devices. More specifically, the present invention relates to a training device that simulates the injection of a drug by an automatic injection device more precisely by means of a damping unit and / or a training device that has an actuation set that it is configured such that the device can be reused easily. Additional aspects of the invention relate to a refill unit for an automatic injection training device. Related Technique
    [0002] Automatic injection devices for providing active substances (for example, pen-type injectors) are well known in the art. In many cases, training versions of such devices are necessary to show potential users (for example, patients or healthcare professionals) how a device should be employed and to illustrate the advantages of the device. Such devices are often called "promotion" or "training" devices. The devices should mimic the function of the respective injection device, but, preferably, it should not inject an active substance (for example, into a tissue of a patient or a user using the device). Most preferably, these promotion or training devices should not inject any substance.
    [0003] US 5,071,353 discloses a training device for an automatic injector. The device comprises a cylindrical outer sleeve at the rear portion of which a discharge mechanism is connected. The discharge mechanism comprises a piston, a spiral spring acting on the piston, a locking device, and a safety member. However, this device does not provide means that allow an accurate simulation of the resistance that acts on the discharge mechanism of a regular injection device when an active substance is ejected.
    [0004] WO 2011/151315 discloses a training cartridge for a drug delivery device as well as a method for replacing the cartridge. The cartridge comprises a body substantially cylindrical in shape, a piston that is slidably disposed in the body in an axial direction, and a closure means disposed in an axial end portion of the body. The piston and the closing means confine an inner volume coupled with the exterior through at least one fluid leak channel. According to the disclosed method, several steps are necessary to replace the cartridge.
    [0005] There is still a need for improved automatic injection training devices that can be reused more easily and / or more often. In addition, replacement equipment for such training devices is required.
    [0006] Additionally, there is a need for improved automatic injection training devices that provide a more accurate simulation of drug injection. Summary of the invention
    [0007] In order to overcome one or more of the problems mentioned above, an injection device according to claim 1 and an assembly according to claim 13 is provided.
    [0008] More aspects, improvements and variations are disclosed in the dependent claims, figures and description.
    [0009] In the present application, when the term "distal" is used, it refers to the direction that points away from the dosing distribution site. When the term "distal end / part" is used, it refers to the part / end of the dispensing device, or parts / end thereof, which are located farthest from the dosing distribution site. Correspondingly, when the term "proximal" is used, it refers to the direction that points to the dosing distribution site. When the term "proximal part / end" is used, it refers to the part / end of the dispensing device, or parts / end thereof, which are located closest to the dosing distribution site. With the training device of the present invention, any suitable surface can form the dosing distribution site (even if no dose is actually delivered).
    [00010] Additionally, the term injection simulation preferably refers to the phase that follows the action of the loaded device, that is, the phase in which a regular automatic injection device can insert a needle into the patient's skin and / or inject a substance active. The training device of the present invention can be provided with a dispensing member or an element that resembles such a dispensing member, but preferably does not comprise such a dispensing member (for example, a needle).
    [00011] The automatic injection training device of the present invention comprises a housing assembly, an actuation assembly, and a damping unit. The housing set has an external housing. The damping unit has a damping housing and a piston assembly which is arranged in said damping housing. The damping housing and piston assembly are preferably configured such that the damping housing slides in a proximal direction with respect to the piston assembly during the injection simulation.
    [00012] The housing assembly of the device of the present invention may further comprise a proximal end cover and a distal end cover. The housing assembly may have an opening at its proximal end (for example, an opening provided in the proximal end cover and extending along the longitudinal axis of the device). The opening can be covered by a removable cover.
    [00013] The damping unit can be arranged in the external housing. The damping housing can be slidably arranged in the external housing and can be slidable along the longitudinal axis of the device. In this way, the damping housing can slide in the proximal direction along the longitudinal axis of the device during the injection simulation. The damping housing may be operatively associated with a first energy accumulation member such that, due to an axial output force from the first energy accumulation member, the damping housing is movable relative to the piston assembly and / or in relation to the external housing towards the proximal end of the device from a loaded position to a position following the injection simulation. The first energy accumulation member can be a first spring, for example, a first helical spring.
    [00014] The damping housing may contain a damping fluid that is sealed within the damper. According to embodiments of the invention, the damping housing may have a cup-shaped structure that is sealed at the proximal end. Suitable damping fluids include gases and liquids, for example, air or viscous fluids (for example, grease).
    [00015] The movement of the damping housing in the proximal direction preferably mimics the sound produced by regular injection devices at the beginning of penetration, providing users of the training device with a similar sound response. Additionally or alternatively, a sound element can be provided to produce an audible response when the damping housing almost reaches the position following the injection simulation. In the embodiments, the damping housing can interact with said sound element, which can be a flexible lever connected with some other component of the device, for example, a sleeve surrounding the damping housing.
    [00016] The position of the piston assembly in relation to the external housing can be substantially fixed during the injection simulation. According to embodiments of the invention, the piston assembly can be coupled with a damper rod, which can be fixedly arranged at a distal end of the device. The damper rod can be maintained by an element of the housing assembly and / or an element of the actuation assembly, for example, an actuator. The damper rod can act as a spring guide for the first coil spring.
    [00017] The piston assembly can be configured to provide a first resistance for the flow of fluid in a proximal direction through it and a second resistance for the flow of fluid in a distal direction through it, the first resistance being greater than than the second resistance. On the one hand, this can guarantee realistic damping that mimics the injection of an active substance through a dispensing member is provided during the simulation of the injection when the device is activated. On the other hand, as will be described in more detail below, the training device can be easily recharged, requiring minimal force.
    [00018] According to embodiments of the invention, the piston assembly may comprise a piston and a valve element. The piston can have one or more fluid passages and the valve element can be configured to obstruct or inhibit fluid flow through said passages in a certain direction. The piston can be arranged around a distal portion of the valve element and the fluid passage can be provided by a gap formed between the piston and the valve element. Alternatively or additionally, the distal portion of the valve element may be provided with recesses and / or indentations to provide one or more fluid passages in conjunction with the piston.
    [00019] Preferably, the valve element blocks or inhibits fluid flow through passage in a proximal direction. The valve element may have an enlarged portion (e.g., a disk shaped structure) that provides one or more openings for fluid flow through it and is located on a proximal side of the piston. The piston can be movable with respect to the valve element. In particular, the piston can be configured to be moved in the proximal direction by the fluid pressure when the damping housing is moved in the proximal direction. This can lead to a contact surface of the piston being pressed against the valve element such that the openings of the valve element are sealed and flow through the blocked passage. In addition, the piston can be configured to be moved in the distal direction by the fluid pressure when the damping housing is moved in the distal direction, thus separating the contact surface from the openings and allowing the flow of fluid through said openings and through the fluid passage. The contact surface can be a closed surface and can face in the proximal direction.
    [00020] The piston may additionally comprise a distal tapered portion that tapers to an internal wall of the damping housing in a distal direction.
    [00021] The damping unit may additionally comprise a pusher element, which may have a proximal portion that is connected and / or attached to the damping housing. According to embodiments of the invention, the impeller element may have a distal hollow portion that accommodates the damper rod and / or the first energy accumulation member. The output force from the first energy accumulation member can act on the impeller element which can transmit this force to the damping housing. The damper rod can extend into the damping housing through an opening in the proximal portion of the impeller element. The damping unit may additionally comprise a seal to ensure that the damping fluid does not leak through the opening (for example, when the damping housing is moved). The seal can interact with and / or seal against the damper rod. In addition, the seal can be arranged between the damping housing and the pusher element.
    [00022] The impeller element may have one or more recesses, projections and / or openings to be maintained by an element of the joint actuator, for example, the actuator. The recesses, projections and / or openings can be provided along a distal portion of the pusher element.
    [00023] According to the modalities of the invention, the actuation set comprises a first sleeve, the actuator, and / or a second sleeve.
    [00024] The first actuator sleeve or sleeve can be arranged in a sliding manner in relation to the external housing and operatively associated with a second energy accumulation member such that the first sleeve is axially movable in relation to the external housing towards the distal end of the device from a starting position to a retracted position against an axial force from said second energy accumulation member and / or such that, due to an axial outgoing force from said second member of energy accumulation, the sleeve is axially movable with respect to the external housing a predetermined distance towards the proximal end of the device from the retracted position to the starting position. The second energy accumulation member can be a second spring, for example, a second helical spring. The second helical spring can be provided around the first sleeve and support against the housing assembly (for example, the distal end cover) and / or the actuator.
    [00025] The sleeve can be formed as a hollow structure having a central opening configured to accommodate the actuator in it. In the embodiments, an internal surface of the sleeve or ribs provided on such an internal surface may taper towards the longitudinal axis of the device when they follow the sleeve in the distal direction.
    [00026] The actuation set of the devices according to the present invention can comprise the actuator, which can play a portion that can be polarized. The polarizable portion may have a first segment that has a first outer diameter and a second segment that has a second outer diameter that is larger than the first outer diameter. According to embodiments of the invention, the second segment can be located proximal to the first segment. The polarizable portion can be formed by resilient arms.
    [00027] The position of the actuator along the longitudinal axis of the device can be substantially fixed in relation to the external housing. When the damping housing is in the charged position, the movement of the damping housing towards the proximal end of the device (for example, to the position following the injection simulation) can be substantially inhibited by at least a portion that can be polarized that interacts with the damping housing and / or the pusher element. The actuator may be in the form of a hollow body that has a central opening and accommodates the impeller element and / or the damping housing. The polarizable portion can be provided with an internal protrusion which is protruding into a central opening of the actuator and engages the damping housing and / or the impeller element when the damping housing is in the charged position. For example, the internal protrusion may engage openings, recesses and / or protrusions provided for the pusher element and / or the damping housing. The internal protrusion can be provided in the region of the second segment.
    [00028] In the loaded position of the damping housing the portion that can be polarized can be forced or polarized in the outward direction due to the axial force of the first energy accumulation member acting on the impeller element and / or the damping housing . However, when the first sleeve is in the starting position, it preferably overlaps at least part of the portion that can be polarized and / or at least part of or all of the second segment, thereby obstructing or inhibiting the portion that can be polarized from fold out. The pusher element and / or the damping housing thus remains engaged by the portion that can be polarized (for example, its internal protrusion). The internal protrusion of the actuator and / or the opening, recess or protrusions of the pusher element can be tapered such that a force having an outward direction component acts on the portion that can be polarized when the axial force of exit from the first accumulation member energy pushes the propelling element in the proximal direction.
    [00029] The sleeve can be arranged and / or configured further such that the polarizable portion folds out and releases the damping housing and / or the pusher element from the loaded position when the first sleeve is moved in one direction distal (for example, to the stowed position). For example, the first sleeve can be shaped such that an opening or a long recess in an inner surface of the sleeve overlaps the portion that can be polarized (in particular the second segment) when the sleeve is retracted. Alternatively or additionally, the proximal end of the first sleeve can be arranged distally from the portion that can be polarized and / or distally from the second segment when the first sleeve reaches the retracted position.
    [00030] The actuation set of the devices according to the present invention can also comprise a second sleeve. This second sleeve can have the shape and function of a needle cover of regular automatic injection devices and therefore is also called a "needle cover" in the context of the present invention.
    [00031] The second sleeve may be operatively associated with the first sleeve and may have a proximal end that extends out of the housing assembly in a proximal direction when the sleeve is in the starting position. Preferably, the second sleeve is arranged such that it is slid in the distal direction with respect to the external housing when a user presses the device to a dosing distribution site. In this context, the second sleeve can be arranged slidably with respect to the external housing and movable with respect to the external housing towards the distal end of the device from a starting position to a retracted position against an axial force from a energy accumulation member, for example, the second energy accumulation member. The second sleeve may protrude a first distance from the housing assembly when it is in the starting position and protrude a second distance from the housing assembly when it is in the stowed position, the second distance being less than the first distance. When the second sleeve is pressed against the dosing distribution site, it preferably pushes the first sleeve in a distal direction (for example, to its retracted position) such that the first sleeve releases and / or does not overlap the second portion segment which can be polarized once the second sleeve reaches a predetermined position (for example, the retracted position).
    [00032] The second sleeve can also be arranged such that, due to an axial output force from an energy accumulation member (for example, the second energy accumulation member), the second sleeve is axially movable in relation to the external housing, a predetermined distance towards the proximal end of the device from the retracted position to the starting position. According to modalities of the invention, the second sleeve is not locked in a proximal position (for example, the starting position) after an injection simulation has been carried out.
    [00033] The second sleeve can provide the sound element to produce a sound when the damping housing reaches close to the position following the injection simulation. For example, the needle cover may comprise a flexible lever that is actuated by the damping housing.
    [00034] According to embodiments of the invention, a needle cover extension can be provided at the proximal end of the second sleeve. The needle cover extension can be attached to the second sleeve and can interact with the proximal end cover to limit movement of the second sleeve in the distal direction. For example, the needle cover extension may have a diameter that is larger than the diameter of the second sleeve and / or the opening provided at the proximal end of the housing assembly (for example, the opening provided in the proximal end cover ).
    [00035] The first sleeve and / or the actuator can be configured such that the second segment of the portion that can be polarized is overlaid by the first sleeve again when the first sleeve is moved back to the start position after the injection simulation is performed and the device is removed from the dosing distribution site. This can be facilitated by the actuator that has a segment tapering between the first segment and the second segment and / or the sleeve that has a tapered internal surface (see above).
    [00036] According to the modalities of the invention the device can be configured to be rechargeable. For this purpose, the damping housing may be axially movable in relation to the external housing and / or in relation to the piston assembly towards the distal end of the device from the position following the injection simulation to the loaded position, preferably against the axial force of the first energy accumulation member. The polarizable portion of the actuator can be configured to re-engage the damping housing and / or the impeller element when the damping housing reaches the charged position. As mentioned above, the portion that can be polarized can be overlapped by the first sleeve and inhibited from bending out substantially (first sleeve in the starting position) when the device is removed from the dispensing site. Preferably, the portion that can be polarized can still be extended slightly, such that the pusher element can be slid along the internal protrusion of the actuator until said internal protrusion engages the opening, recess and / or protrusion of the pusher element again .
    [00037] As will be apparent to the person skilled in the art from the current description, an internal opening or recess may be provided in the portion that can be polarized instead of or in addition to the internal protrusion described above when a corresponding external protrusion is provided for the drive element and / or the damping housing.
    [00038] In order to facilitate the re-loading of training devices, the present invention additionally relates to a refill unit. The refill unit can be provided in a set comprising said refill unit and any of the devices described above.
    [00039] The refill unit may comprise a shaft member, an ejector and / or a support. The support that can have a first portion that can be configured to accommodate the training device housing assembly therein. The first portion may be a hollow and substantially cylindrical structure that extends along the longitudinal axis of the device when the refill unit is arranged for a refill procedure. In addition or alternatively, the holder may have a second portion configured to provide a base for supporting the refill unit in an upright position.
    [00040] the shaft member can be arranged within the first portion of the support. The shaft member can be configured to extend through a proximal opening of the needle cover such that the damping housing can be pushed in the distal direction by means of the shaft. The length of the shaft member can be sufficient to push the damping housing from the position following the simulation of the injection to the loaded position. Preferably, the shaft member is a separate member which is attached to the second portion of the support. In order to recharge the device, it can be inserted into the holder and pressed into the base. The device is thus moved in the axial direction with respect to the fixed shaft member, which will extend towards the device and push the damping housing in the distal direction.
    [00041] the ejector can be configured to eject the housing from the refill unit after the refill procedure is complete. For this purpose, the ejector can be slidably arranged in relation to the shaft member and operatively associated with a third energy accumulation member such that the ejector is axially movable with respect to the shaft member from a starting position to a retracted position against an axial force from said third energy accumulation member and / or such that, due to an axial output force from said third energy accumulation member, the ejector is movable from axially in relation to the shaft member from the retracted position to the starting position. The third energy accumulation member can be a third spring, for example, a third helical spring.
    [00042] In order to avoid activation of the device during the refill procedure is complete, the ejector may have a first end with a cup-shaped structure that is configured to accommodate the proximal end of the needle cover extending outside the set of housing and to support against a contact surface of said housing assembly when the device is being recharged. The cup-shaped structure, therefore, prevents the needle cover from being moved in the distal direction, which can lead to activation of the actuation set. The ejector can be operatively coupled with the shaft member such that the ejector is prevented from falling out of the holder. For example, the ejector can be provided with a pin that extends through an opening in the shaft member.
    [00043] Aspects of the invention may refer to the refill unit or the damping unit described above as stand-alone components. Brief description of the drawings
    [00044] The following Figures below disclose one embodiment of the invention for purposes of illustration only. In particular, the disclosure within the Figures should not limit the protection range of the invention. The modality shown can be modified in several ways within the scope of the claims.
    [00045] Figure 1 is a perspective view of a device according to an embodiment of the present invention.
    [00046] Figure 2 is an exploded view of a housing assembly for the device of Figure 1.
    [00047] Figure 3 is a sectional view of a damping unit of the device of Figure 1.
    [00048] Figure 4 is a perspective view of a damping housing of the damping unit of Figure 3.
    [00049] Figure 5A is a perspective view of a piston assembly of the damping unit in Figure 3.
    [00050] Figure 5B is a rotated sectional view showing the piston assembly of Figure 5A in the open position.
    [00051] Figure 5C is a rotated sectional view showing the piston assembly of Figure 5A in the closed position.
    [00052] Figure 6A is a perspective view of an impeller element of the damping unit of Figure 3.
    [00053] Figure 6B is a sectional view of the driving element of Figure 6A.
    [00054] Figure 7 is an exploded view of an actuation set of the device of Figure 1.
    [00055] Figure 8A is a perspective view of an actuator from the actuation set of Figure 7.
    [00056] Figure 8B is a top view of the actuator in Figure 8A.
    [00057] Figure 8C is a sectional view of the actuator in Figure 8A.
    [00058] Figure 9A is a perspective view of a first sleeve of the actuation set of Figure 7.
    [00059] Figure 9B is a sectional view of the first sleeve of Figure 9A.
    [00060] Figure 10A is a perspective view of a needle cover of the actuation set of Figure 7.
    [00061] Figure 10B is a sectional view of the needle cover of Figure 10A.
    [00062] Figures 11 to 16 are sectional views of the delivery device of Figure 1 that illustrate the preparation, activation, injection simulation and removal from the dosing distribution site.
    [00063] Figure 17A is an exploded view of a refill unit according to the modalities of the present invention.
    [00064] Figure 17B is a sectional view of the refill unit of Figure 17A in an assembled state.
    [00065] Figure 18A is a sectional view of a device according to the present invention in a position following the injection simulation with the refill unit of Figure 17A arranged at the proximal end.
    [00066] Figure 18B is an enlarged view of the distal part of the device shown in Figure 18A, illustrating details of the actuation set.
    [00067] Figure 19A is a sectional view of the device and the refill unit of Figures 18A and 18B with the damping housing in the loaded position following the refill.
    [00068] Figure 19B is an enlarged view of the distal part of the device shown in Figure 19A, illustrating details of the actuation set.
    [00069] Detailed description of the drawings
    [00070] As shown in Figure 1, a device 1 according to the present invention may comprise a housing assembly 2 and extend along a longitudinal axis L. The housing assembly 2 may be open at the proximal end (not shown ) and can be closed with a removable cover 9. As further illustrated in Figure 2, housing assembly 2 can comprise an outer housing 3, a proximal end cover 4 with an opening 5 extending along the longitudinal axis L, and a distal end cover 6. The proximal end cover 4 can be inserted into the outer housing 3 and attached to it such that the opening 5 is coaxial with the longitudinal axis L. The outer housing 3 may comprise an inspection window (not shown ) to assess the position of the damping housing and / or the state of the actuation set.
    [00071] Figure 3 shows a sectional view along the longitudinal axis L of a damping unit 10 that can be inserted into the outer housing 3 of the device 1 of Figure 1. The damping unit 10 comprises a damping housing 11 and a piston assembly 13 with a piston 14 and a valve element 15 which is arranged in said damping housing 11. The damping unit 10 shown in Figure 3 additionally features an impeller element 12, a damper stem 18, and a seal 19 The pusher element 12 is fixedly attached to the damping housing 11, the seal 19 which is arranged and maintained between these two components. As can also be seen in Figure 4, the damping housing 11 has a cup-shaped structure that is closed at the proximal end. The damping fluid (for example, air or grease) is thus sealed in the damping housing 11. In the fluid passage through which the damping fluid must escape is provided in the proximal and / or distal part of the damping housing cushioning 11.
    [00072] As further shown in Figure 3, the piston assembly 13, more specifically the valve element 15, can be attached to the damper rod 18, which extends to the damping housing 11 and through the impeller element 12 from from a distal attachment point 181. The piston assembly 13 is therefore substantially fixed in relation to the housing assembly.
    [00073] Meanwhile, the damping housing 11 can be slidably arranged in the outer housing of the device 1 along the longitudinal axis L and can be slid in the proximal direction along the longitudinal axis L of the device during the injection simulation. For this purpose, the pusher element 12 is associated with a first energy accumulation member in the form of a first coil spring 34 which is arranged around the damper rod 18. As will be explained below, when an injection is simulated, the element impeller 12 and damping housing 11 are moved relative to the piston assembly 13 towards the proximal end of device 1 by the axial outlet force from the first helical spring 34, thereby pressing the damping fluid in a proximal direction through piston assembly 13.
    [00074] In order to provide a realistic cushioning effect that simulates the cushioning that occurs when an active substance is distributed through a dispensing member (for example, a needle or nozzle from a regular automatic injection device), but still allows for easy replacement, the piston assembly 13 of the present invention can be configured to provide a first resistance for the flow of fluid in a proximal direction through it and a second resistance for the flow of fluid in a distal direction through it, in that the first resistance is greater than the second resistance.
    [00075] As is shown more clearly in Figure 5B, which represents another sectional view of the piston assembly 13 which is rotated 90 ° with respect to the view of Figure 3, a fluid passage 141 extends through the piston assembly 13. In the embodiment shown, the fluid passage 141 is provided between a central opening of the piston 14 and the distal portion of the valve element 15, which has a smaller outside diameter than the inside diameter of the central opening. Additionally, the valve element 15 is provided with cutouts.
    [00076] When the fluid pressure on the proximal side of piston assembly 14 is greater than on the distal side (damping housing 11 being moved in the distal direction when the device is being refilled), piston assembly 14 assumes the position of the Figure 5B, where the damping fluid can easily flow through the openings 151 in an enlarged portion 152 of the valve element 15 and through the fluid passage 141 (see also Figure 5A). In contrast, when the fluid pressure on the distal side of piston assembly 14 is greater than on the proximal side (damping housing 11 being moved in the proximal direction during the injection simulation), piston 14 is moved to the valve element 15 such that the contact surface 142 obstructs the flow of fluid through the openings 151. As shown in Figure 5C, the opening 151 is covered almost completely, such that the flow of the fluid is substantially restricted.
    [00077] Figures 6A and 6B show perspective and sectional views of the driving element 12 of Figure 3, respectively. As shown here, the pusher element 12 can have a proximal portion 121 that can be configured for attachment with the cushion housing 11 and / or the seal 19. The distal portion 123 of the pusher element 12 can be hollow and can be configured to accommodating the damper rod 18 therein, which can extend into the damping housing 11 through a hole 122 in the proximal portion 121.
    [00078] In order to retain the damping housing and the pusher element in the loaded position, the pusher element 12 has openings 124 in which a protrusion of the actuator can extend, as will be described in more detail below. Recesses or protrusions (not shown) can be provided instead of or in addition to openings 124.
    [00079] Figure 7 shows an exploded view of an actuation assembly 30 that can be used for a device 1 according to the present invention. The actuation set 30 comprises a first sleeve 33 which is operatively associated with a second energy accumulation member in the form of a second helical spring 35, an actuator 32, and a needle cover 31. A needle cover extension 39 can be provided at the proximal end of the needle cover 31.
    [00080] As illustrated in Figures 8A-8C, the actuator 32 can be a generally tubular structure with a central opening 327 that extends along the longitudinal axis L of the device. The central opening 327 can be configured to accommodate the impeller element and / or the damper rod. A distal portion 328 can provide one or more attachment structures 329 for engaging the actuator 32 with the outer housing and / or the distal end cover. An additional attachment structure can also engage the damper rod 18 and retain it in a fixed manner.
    [00081] The actuator 32 may have a polarizable portion 322, which is formed by resilient arms in the illustrated embodiment. The polarizable portion 322 has an internal protrusion 326 that extends to the central opening 327 and is preferably formed near the proximal end of the polarizable portion 322. Additionally, the polarizable portion 322 has a first segment 323 with a first outer diameter and a second segment 324 with a second outer diameter that is larger than said first outer diameter. A tapering segment 325 extending between said first and said second segments 323, 324 which preferably tapers away from the longitudinal axis L of the device 1 in the proximal direction can also be provided. As also shown in Figure 8B and 8C, the second segment 324 can be more proximal than the first segment 323 when the actuator 32 is mounted on device 1. The internal protrusion 326 can be provided in the region of the second segment 324. In other embodiments , an opening or recess may be provided instead of the internal protrusion 326.
    [00082] Figures 9A and 9B show perspective and sectional views of the first sleeve 33. The sleeve 33 is formed by a tubular structure with a central opening 337. The central opening 337 can extend along the longitudinal axis L of the device and can be configured to accommodate actuator 32.
    [00083] The first sleeve 33 is pushed in a direction proximal to its starting position by the axial exiting force of the second helical spring 35 which is operationally associated with said first sleeve 33 and supports, for example, against the cover of distal end 6. When the first sleeve 33 is in said starting position, it covers the polarizable portion 322 of the actuator 32. The polarizable portion 322, therefore, is substantially inhibited from being folded out. With the internal protrusion 326 of the actuator 32 engaging the opening 124 of the pusher element 12, the pusher element 12 is secured in the charged position and inhibited from moving in the proximal direction in relation to the outer housing 3 and the piston assembly 13. As will be described below, the first sleeve 33 is pushed in the distal direction when the device is pressed against a dosing distribution site, releasing the polarizable portion 322 and thus the pusher element 12.
    [00084] Along the inner surface of the central opening 337, between a proximal end 331 and a distal end 335 of the first sleeve 33, ribs 333 can be provided. The ribs 333 preferably contact against the actuator 32, for example, against the tapering segment 325 of the actuator 32, when the sleeve 33 reaches its starting position and prevents the sleeve 33 from moving further in the proximal direction due to the axial force of exit of the second helical spring 35 which is operatively associated with said sleeve 33 (see also Figure 7).
    [00085] Figures 10A and 10B show perspective and sectional views of the needle cover 31, respectively. As shown in these Figures, even the needle cover 31 can be formed as a generally tubular structure with a central opening extending through it and providing an opening at a proximal end 311. One or more cutouts 313 can be arranged in the cover of needle 31 such that the position of the cushion housing 11 can be assessed by looking through the inspection window provided in the outer housing 3, when the needle cover 31 is positioned in the housing assembly 2. A distal end 314 of the needle cover 31 can contacting a protrusion or collar 334 of the first sleeve 33 such that the needle cover 31 is forced in the proximal direction along with the first sleeve 33 by the axial exiting force of the second helical spring 35.
    [00086] Figure 11 illustrates a training device 1 according to the modalities of the present invention in an initial loaded position with the cover 9 covering the proximal end of the device 1. In Figure 12 the cover 9 is removed, such that the device 1 it is prepared to be used. As can be seen in these Figures, the first sleeve 33 and the needle cover 31 are forced in the proximal direction by the second helical spring 35. The first sleeve 33 and the needle cover 31 are in the starting position.
    [00087] The proximal end 311 of the needle cover 31 extends out of the housing assembly 2 a first distance through an opening provided in the proximal end cover 4.
    [00088] With the first sleeve 33 in the starting position, the sleeve 33 covers the polarizable portion 322 of the actuator 32, also overlapping the second segment 324. The polarizable portion, therefore, is inhibited from bending outward in a substantial way. As a result, the pusher element 12 is secured in the position charged by the internal protrusion 326 of the actuator 32 which engages the opening 124 of the pusher element 12. The damping housing 11 and the pusher element 12 are thus inhibited from moving in the direction proximal to the outer housing 3 and the piston assembly 13.
    [00089] When the device 1 is pressed against a surface that serves as a dosing distribution site during the training procedure, the needle cover 31 and the first sleeve 33 are moved in the distal direction in relation to the outer housing 3 from from the starting position (see Figure 12) to a retracted position (see Figure 13) where the proximal end 311 of the needle cover 31 extends out of the housing assembly 2 a second distance which is less than the first distance from the starting position. In alternative embodiments, the needle cover 31 can be pushed into the housing assembly 2 completely.
    [00090] In the retracted position, the first sleeve 33 releases the second segment 324 from the portion that can be polarized 322. For example, as shown in the illustrative embodiment of Figure 13, the proximal end of the first sleeve 33 does not overlap the entire portion that can be more polarized when the sleeve 33 is moved to the stowed position. The polarizable portion 322 (i.e., the resilient arms of the actuator 32) will therefore bend outwardly by an axial output force from the first helical spring 34 acting on the pusher element 12 and transmitted to the portion which can be polarized 322 along the internal protrusion 326. Consequently, the impeller element 12 and the damping housing 11 will be released by the internal protrusion 326 and will move in the proximal direction to a position following the injection simulation due to said force axial exit from the first coil spring 34 (see Figure 14). The movement of the damping housing 11 in the proximal direction is slowed by the piston 13 in order to provide a realistic simulation of the drug delivery. When moving in the proximal direction, the damping unit can also mimic the sound produced by regular injection devices at the beginning of penetration and provide users of training device 1 with a similar audible response. The sound can be produced, for example, by the damping fluid flowing through the piston assembly 13 and / or by sliding the piston assembly 13 along the damping housing 11.
    [00091] Figure 15, which illustrates a sectional view of device 1 in the position of Figure 14 when rotated 90 °, shows that the needle cover 31 can be provided with a lever 315. The lever 315 interacts with the damping housing 11 such that an additional audible response is emitted when the damping housing 11 almost reaches the position following the injection simulation. The response mechanism can also be provided for other components of the device 1, in addition to or alternatively to the lever 315.
    [00092] When the device 1 is removed from the surface that serves as the dosing distribution site (Figure 16), the first sleeve 33 and the needle cover 31 are moved from the retracted position to the starting position due to the force axial outlet of the second coil spring 35. In the illustrative embodiment, the needle cover remains unlocked after.
    [00093] Figures 17A and 17B illustrate a refill unit 80 according to the present invention in an exploded state and in an assembled state, respectively. As shown, the refill unit 80 can have a support 81 with a first hollow portion 812 which is shaped to accommodate the outer housing of the dispensing devices according to the present invention therein. In addition, a base 814 can be provided.
    [00094] A shaft member 83 with a shaft 831 is arranged in the first portion 812 and fixed to the base 814. The longitudinal axis of the shaft 831 and the longitudinal axis of the first portion 812 of the support are preferably congruent. As also shown in Figure 18A, the shaft 831 can be configured such that it can be inserted into the device 1 through the central opening of the needle cover 31. The device 1 can be refilled by inserting the shaft 831 through said central opening and pushing the housing damping 11 in the distal direction from the position following the injection simulation (Figures 18A and 18B) to the loaded position (Figures 19A and 19B). The damping housing 11 and the pusher element 12 will be moved in the distal direction against the axial force of the first helical spring (not shown) until the internal protrusion 326 engages the opening 124 and secures the pusher element 12 in the loaded position. The movement can be carried out easily since the piston assembly 13 provides a relatively low resistance to the flow of fluid in the distal direction therethrough. With the first sleeve 33 in the starting position (see Figures 11 and 12), the damping housing 11 remains in the loaded position until the actuation set is activated again.
    [00095] Once the refill of device 1 is complete, device 1 can be ejected from the refill unit 80 via an ejector 85. Ejector 85 is moved from a start position (Figure 18A) to a Retracted position (Figure 19A) against the axial output force of a third energy accumulation member in the form of a third helical spring 87 when the device is being reloaded. Therefore, the third coil spring 87 will force the ejector back to its starting position when the force exerted during the refill procedure is complete (for example, by a user who refills the device 1) is released and ejects the device 1 of the refill unit 80. In the illustrated embodiment, the ejector 85 has a cup-shaped structure 852 at a first end, which is the end of the ejector 85 that interacts with device 1. The cup-shaped structure is shaped to accommodate the end proximal 311 of the needle cover 31 extending outside the housing assembly so that the actuation assembly is not activated during the refill procedure is complete.
    [00096] While the invention has been illustrated and described in detail in the drawings and in the previous description, such illustrations and description should be considered as illustrative or exemplary and not restrictive. It will 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 covers additional modalities with any combination of features of different modalities described above.
    [00097] Additionally, 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 fulfill the functions of several functionalities mentioned in the claims. The terms "essentially", "about", "approximately" and the like together with 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]
    1. Automatic injection training device (1) characterized by the fact that it comprises a housing assembly (2) comprising an external housing (3); an acting set (30); and a damping unit (10) comprising a damping housing (11) and a piston assembly (13) arranged in said damping housing (11), wherein the damping housing (11) slides in a proximal direction with respect to to the piston assembly (13) when an injection is simulated, in which the damping housing (11) is operationally associated with a first energy accumulation member (34) such that, due to an axial output force from of the first energy accumulation member (34), the damping housing is movable in relation to the piston assembly (13) and / or the external housing (3) towards the proximal end of the device (1) from a position loaded to a position following the injection simulation, and in which the piston assembly (13) is configured to provide a first resistance for the flow of fluid in a proximal direction through it and a second resistance for the flow of fluid in a di distal reaction through it, the second resistance being less than the first resistance.
    [0002]
    2. Device (1) according to claim 1, characterized by the fact that the position of the piston assembly (13) in relation to the outer housing (3) is substantially fixed during the injection simulation.
    [0003]
    Device (1) according to either of claims 1 or 2, characterized in that the piston assembly (13) comprises a piston (14), a valve element (15), and a fluid passage (141), and where the piston (14) cooperates with the valve element (15) to obstruct the flow of fluid through the passage (141) in the proximal direction.
    [0004]
    4. Device (1) according to any one of the preceding claims, characterized by the fact that the actuation set (30) comprises a sleeve (33) which is arranged in a sliding manner in relation to the external housing (3) and associated operationally with a second energy storage member (35) such that the sleeve (33) is axially movable with respect to the external housing (3) towards the distal end of the device (1) from a position starting to a retracted position against an axial force from said second energy accumulation member (35) and / or such that, due to an axial exit force from said second energy accumulation member (35), the sleeve (33) is axially movable with respect to the outer housing (3) a predetermined distance towards the proximal end of the device from the retracted position to the starting position.
    [0005]
    5. Device (1), according to any one of the preceding claims, characterized by the fact that the actuation set (30) comprises an actuator (32); wherein the actuator (32) has a portion that can be polarized (322) with a first segment (323) having a first outer diameter and a second segment (324) having a second outer diameter, the second segment (324) being more proximal than the first segment (323) and the second outer diameter being larger than the first outer diameter; and wherein the sleeve (33) overlaps at least part of the second segment (324) and inhibits the polarizable portion (322) from moving in an outward direction when the sleeve (33) is in the starting position.
    [0006]
    6. Device (1) according to claim 5, characterized by the fact that the actuator (32) additionally has a tapering segment (325) between the first segment (323) and the second segment (324).
    [0007]
    7. Device (1) according to claim 5 or 6, characterized by the fact that, when the damping housing (11) is in the loaded position, the movement of the damping housing (11) towards the proximal end of the device (1) is substantially inhibited by at least a polarizable portion (322) that interacts with the damping housing (11) and / or an impeller element (12) connected with said damping housing (11).
    [0008]
    Device (1) according to any one of claims 5 to 7, characterized in that, when the damping housing (11) is in the loaded position and the sleeve (33) is moved to the stowed position, the polarizable portion (322) folds out and releases the cushion housing (11) and / or the pusher element (12).
    [0009]
    9. Device (1) according to any one of the preceding claims, characterized by the fact that the damping housing (11) is axially movable in relation to the external housing (3) and / or in relation to the piston assembly (13) towards the distal end of the device (1) from the position following the injection simulation to the loaded position against the axial force of the first energy accumulation member (34).
    [0010]
    10. Device (1) according to any one of the preceding claims, characterized by the fact that the actuation set (30) additionally comprises a needle cover (31) that is associated in an operational or integral manner with the sleeve (33) and has a proximal end that extends out of the housing assembly (2) in a proximal direction when the sleeve (33) is in the starting position.
    [0011]
    11. Assembly characterized by the fact that it comprises a device (1) as defined in any of the preceding claims and a refill unit (80), comprising a shaft member (83) which is configured to be inserted into the external housing (3 ) through a proximal opening of the needle cover (31), an ejector (85) which is arranged slidably in relation to the shaft member (83) and operatively associated with a third energy accumulation member (87) such that the ejector (85) is axially movable with respect to the shaft member (83) from a starting position to a retracted position against an axial force from said third energy accumulation member (87) and / or such that, due to an axial output force from said third energy accumulation member (87), the ejector (85) is axially movable with respect to the shaft member (83) from the retracted position to the starting position.
    [0012]
    12. Assembly according to claim 11, characterized by the fact that the refill unit (80) comprises a support (81) which has a first portion (812) configured to accommodate and / or guide the housing assembly (2 ) and / or where the refill unit (80) comprises a second portion (814) configured to provide a base for supporting the refill unit (80) in an upright position.
    [0013]
    13. Assembly according to claim 11 or 12, characterized in that the ejector (85) has a first end with a cup-shaped structure (852) which is configured to accommodate the proximal end of the needle cover (31 ) extending outside the housing assembly (2) thereon and which is configured to support against a contact surface (9) of the housing assembly (2) when the device (1) is being recharged.
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    同族专利:
    公开号 | 公开日
    US20150235571A1|2015-08-20|
    JP6047238B2|2016-12-21|
    CA2887471A1|2014-04-17|
    TW201428702A|2014-07-16|
    WO2014056868A1|2014-04-17|
    US10127836B2|2018-11-13|
    CN104781869B|2017-06-09|
    BR112015008015A2|2017-07-04|
    EP2907126B1|2019-01-23|
    ZA201502435B|2017-08-30|
    JP2015532466A|2015-11-09|
    RU2617275C2|2017-04-24|
    KR101767793B1|2017-08-11|
    AU2013328869B2|2016-06-02|
    TWI503799B|2015-10-11|
    AU2013328869A1|2015-05-07|
    EP2907126A1|2015-08-19|
    CN104781869A|2015-07-15|
    CA2887471C|2018-05-15|
    KR20150068454A|2015-06-19|
    RU2015117529A|2016-11-27|
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    法律状态:
    2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-12-24| B25A| Requested transfer of rights approved|Owner name: SHL MEDICAL AG (CH) |
    2020-03-31| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-07-21| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-10-13| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 08/10/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
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    US201261712299P| true| 2012-10-11|2012-10-11|
    US61/712,299|2012-10-11|
    SE1251149|2012-10-11|
    SE1251149-9|2012-10-11|
    PCT/EP2013/070878|WO2014056868A1|2012-10-11|2013-10-08|Automatic injection training device|
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