Automated Drug Delivery Device

Abstract

To provide an automatic drug delivery device for dispensing a fluid medicament.SOLUTION: An automatic drug delivery device includes: a longitudinal housing (104); a removable cap (50) mountable to the proximal end of the housing; a syringe assembly (200) arranged inside the housing and having a hollow syringe body (204) and an injection needle (206) coupled to the hollow syringe body; and a drive mechanism which can be triggered by a trigger element in order to initiate the dispensing of the fluid product, wherein the loaded drive mechanism is operatively coupled with a safety shield (102) movable within the longitudinal housing, wherein the safety shield is biased into a proximal position in which it protrudes out of the proximal end of the longitudinal housing (104) in order to cover a needle tip of the injection needle, and wherein the safety shield is movable into a distal position in which the injection needle is exposed for injection; and wherein the device further includes a feedback mechanism that provides visible feedback that displays a state of an operation to a user, and the feedback mechanism includes a visible display unit that appears in a transparent window on the distal end of the housing.SELECTED DRAWING: Figure 2-3

Description

[Technical Field]

[0001] The present invention relates to an automated drug delivery device, particularly a device for delivering fluid products, particularly fluid medications, to a patient. This invention relates to an autoinjector for

[0002] Automatic drug delivery devices configured as autoinjectors are well known in the prior art. There are various types of automatic drug delivery devices available. Current state of the art automatic drug delivery devices include: While providing reliable functionality, it still has many drawbacks that need to be overcome. [Background technology]

[0003] EP 2745866B1 discloses a safety shield that acts as a trigger element. The automatic drug delivery device includes a patient to be injected. The injection is initiated by pressing the safety shield against the injection site on the patient's skin. The syringe is pressed into the longitudinal housing of the automatic drug delivery device, thereby initiating the injection process. When the injection is completed and the automatic drug delivery device is removed from the injection site, The entire shield is pushed out from the longitudinal housing and is in a safe position to cover the needle tip with a blocking mechanism. The blocking mechanism is formed in the safety shield and has flexible arms in the multiple components. This structure makes the safety shield complex in terms of geometry and manufacturing. The flexible arms of certain safety shields allow the safety shield to move longitudinally into the housing after use. does not provide sufficient protection against

[0004] European Patent No. 2903670B1 describes a mechanism in which the interlocking member rotates relative to the actuating member. The present invention describes an automatic drug delivery device that operates by Rotational relative motion between different components is required to operate the automated drug delivery device. Such rotational movements are often counter-intuitive, which can make such automated drug delivery devices Further automatic drug delivery devices with rotating components are available in Europe. It is known from the state patent application 2583711A1.

[0005] Additionally, the injection process can be performed by pressing a button formed on the distal end or on the outer circumferential side of the device. There are automatic drug delivery devices that are triggered by a drug delivery device. The trigger mechanism can be activated even if the trigger is not placed correctly, which increases the risk of misuse. This includes the possibility of

[0006] EP 2978471B1 describes a method for applying pressure to an injection site with a safety shield. However, the actuation mechanism is Its structure is complex, requiring multiple parts that interact with each other during their relative motion. As a result, manufacturing and assembly is complex.

[0007] U.S. Patent Application Publication No. 2016 / 0331905A1 discloses a ratchet assembly The present invention describes an automated drug delivery device that includes an actuation mechanism having different flexible arms. The device interacts with a notched rack. Due to the multiple components and moving elements, The device is susceptible to misuse and incorrect operation. Moreover, it is complex to manufacture and assemble.

[0008] In addition to the assembly and function of the actuation mechanism, a further challenge with automated drug delivery devices is the assembly and function of the pre-filled syringe. The pre-filled syringe assembly is then positioned and held in place. The syringe typically includes a glass body pre-filled with the fluid product to be dispensed. The glass body should be handled with extreme care during assembly to prevent it from being affected. To avoid handling, this prior art document suggests the use of a syringe holder. .

[0009] Also, when the syringe carrier is bent from the pre-assembled state and an axial force is applied to the syringe carrier, the syringe carrier is released. WO 2016 / 11164 describes a particular syringe holder with a flexible arm. See also WO 93374A1. An alternative syringe transport container is disclosed in WO 201 This syringe carrier is described in the brochure No. 6 / 193355A1. A syringe is provided with an axial biasing force within the housing of the drug delivery device. The syringe holder is disclosed in the document WO 2007 / 083115 A1. Moreover, the document in WO 2015 / 015230A2 is A syringe holder is described that includes a guard element for transferring load to a syringe support. A further prior art syringe-carrying container has two associated syringes with a C-shaped proximal receiving member. WO / 089620A1 provides interconnected annular members using connecting arms. It is known from the pamphlet.

[0010] A further challenge with automated drug delivery devices is providing a feedback signal to the user. Such feedback signals can be audible, visual or tactile. The document in WO 2016 / 193343A1 describes an audible signal generator including an elastic arm. An automated drug delivery device with an indicator is described, wherein the resilient arm moves radially during use. It deflects outward and then releases, thereby generating an audible signal.

[0011] Additionally, another embodiment of the automatic drug delivery device utilizes a removable cap, The cap may be removed from the housing of the automated drug delivery device while the pre-filled syringe is in use. Remove the rigid needle shield from the needle of the instrument assembly. This document is known from WO 2012 / 103140 A1. A relatively complex structure of a removable cap having multiple cap engagement mechanisms is described. It is listed. Summary of the Invention [Means for solving the problem]

[0012] Dosing end features The automated medication delivery device may provide tactile and / or audible and / or visual feedback to the user to indicate operational status. The device may further include a feedback mechanism for providing visual feedback. The structure may include a visual indicator that appears within the distal end of the housing. The visual indicator may appear within a window. The window may be provided by a hole or may be made from a transparent or translucent material. The window and / or distal end of the housing may be configured to allow the visual indicator to appear at angles ranging up to 360°. The window and / or the distal end of the housing may be transparent or translucent around its entire periphery. , provided by the housing or by a separate part, such as an end cap, coupled to the housing. This may also be done.

[0013] The present invention provides an automated medication delivery device for dispensing a fluid product, comprising: The nozzle extends along a longitudinal axis and has a proximal end near the dispensing location, a distal end opposite the proximal end, and a center a longitudinal housing having a hollow interior; a removable cap attachable to the proximal end of the housing; A hollow syringe body is disposed at a mounting position inside the housing and is connected to the hollow syringe body containing the fluid product. a syringe assembly having an attached needle; a drive mechanism that can be actuated by a trigger element to initiate dispensing of the fluid product; and the drive mechanism is operably coupled to a safety shield movable within the longitudinal housing; The safety shield extends from the proximal end of the longitudinal housing to cover the tip of the needle. The needle is biased to a proximal position where it projects, and the safety shield is biased to a distal position where the needle is exposed for injection. It is movable to The device is a feedback system that provides the user with visual feedback indicating the actual state of operation. The feedback mechanism further includes a visual indication that appears within a transparent window on the distal end of the housing. An automated drug delivery device is also provided, which includes a container.

[0014] The visual indicator may move distally to appear within the transparent window. Radial inner indicator components and radial outer indicators biased into indicator position by springs The external indicator may be formed by a component that indicates to the patient that the predetermined dose of the drug has been delivered. After delivery, it may be released to the indicated position. Although there may be some, the majority of the dose, more than 70% of the dose, more than 90% of the dose, or the actual dose The predetermined dose may be administered until the appearance of a visual indicator indicates the end of the infusion. A visual indicator may be provided to indicate the end of the injection. may appear in a transparent window on the distal end of the housing.

[0015] The external indicator component may include a visible surface. The visible surface provides a visible indicator. A visible surface is a surface that is readily distinguishable from other surfaces or components of the device. The internal indicator may include one or more of a color, a shape, a pattern, a symbol, and an image, for example. The component may be fitted with a housing or a separate part, e.g., a For example, it may interact with an end cap coupled to the housing.

[0016] The device may include a distal end cap closed by the distal face. The distal surface may be formed from a transparent material to provide a transparent window. It may be made.

[0017] The safety shield spring is supported between the shield retention trigger element and the shield retention indicator member. The shield retention trigger member may support the proximal end of the safety shield spring. , the longitudinal arms or each longitudinal arm of the safety shield to bias the safety shield proximally. A biasing force may be applied to the distal end of the manual arm. The distal end of the spring may be supported.

[0018] The present invention provides an automated medication delivery device for dispensing a fluid product, comprising: The nozzle extends along a longitudinal axis and has a proximal end near the dispensing location, a distal end opposite the proximal end, and a center a longitudinal housing having a hollow interior; a removable cap attachable to the proximal end of the housing; A hollow syringe body is disposed at a mounting position inside the housing and is connected to the hollow syringe body containing the fluid product. a syringe assembly having an attached needle; a drive mechanism that can be actuated by a trigger element to initiate dispensing of the fluid product; and the drive mechanism is operably coupled to a safety shield movable within the longitudinal housing; The safety shield extends from the proximal end of the longitudinal housing so that the safety shield covers the tip of the needle. The safety shield is biased to a proximal position where it projects from the needle, and the safety shield is biased to a distal position where the needle is exposed for injection. It can be moved to a different location, The safety shield comprises at least one distally extending longitudinal member guided within the longitudinal housing. and a safety shield is attached to the safety shield via at least one longitudinal arm. The safety shield spring interacts with the shield, which biases the shield proximally. a shield retention trigger member supported between the shield retention indicator member and the shield retention trigger member; The material supports the proximal end of the safety shield spring and is attached to the distal end of the longitudinal arm of the safety shield. Applying force, the shield retention indicator member supports the distal end of the safety shield spring, Also provided is a product delivery device.

[0019] The drive mechanism may include a plunger biased proximally by a drive spring. The syringe is sealably guided within the syringe body and acts on the fluid product contained within the syringe body. The syringe holder may act on the stopper. The force may be received and the force may be transmitted to the longitudinal housing.

[0020] The load or activated drive mechanism may include a retainer. The retainer may be attached to the distal end of the device. The retainer may extend from the syringe body to the syringe body. At least one flexible arm may be configured to hold the plunger in a loaded position. The plunger may be used to hold the plunger in a proximal position, where it is biased proximally.

[0021] The retainer may be resiliently deflectable to bias the syringe body proximally. The retainer may include a proximal ring-shaped head having two opposing protrusions. The proximal ring-shaped head may contact the syringe body, and the proximal ring-shaped head may contact the syringe body. For example, the protrusion may be configured to fit within a syringe body having a diameter of 1 ml. The syringe body may be adapted to fit within a 2 ml syringe body. Preferably, the 2 ml syringe body is positioned such that the proximal ring-shaped head contacts the 2 ml syringe body. It has a larger diameter.

[0022] At least one flexible arm has a chamfered radially outward projection and a chamfered radius The plunger may further include a radially inward protrusion. The chamfered radially inward protrusion Provided to interact with a corresponding engagement surface on the plunger to hold it in the loaded position. At least one flexible arm may be provided with a chamfered radially outward projection. The shield retaining trigger element may be configured to interact with an inner peripheral surface of the shield retaining trigger element.

[0023] When the safety shield is depressed distally to initiate dispensing of the fluid product, the shield Rotate the shield retention trigger element distally so that the retention trigger element compresses the safety shield spring. After a predetermined stroke of the safety shield, the shield retention trigger element At least one flexible arm may be released to move radially outward, thereby The plunger is driven to force the fluid product out of the syringe body through the needle for dispensing. It is released to move proximally under the bias of a spring.

[0024] The shield retention indicator may include at least one longitudinal retention arm, The display surface of the hand-held indicator is not visible through the housing (through a window opening or through a transparent part of the housing). The device may be held by at least one holding arm (positioned so as not to be visible). The shield retention indicator provides a visual indicator. At least one retention arm is The plunger may be held by a holder as long as it does not reach the predetermined dispensing position. When the dispenser reaches the predetermined dispensing position, it releases at least one holding arm from the holder. After releasing at least one retention arm, the shield retention indicator is held in place by the safety shield spring. The display surface may be pressed into a visible position so that it can be seen through the housing. An audible signal is generated when the shield retention indicator reaches its final visible position.

[0025] The shield retention indicator is released and moved to a visible position, with the safety shield covering the needle tip. After being biased, the shield retention indicator may prevent distal movement of the shield retention trigger member. The shield retention trigger member may prevent distal movement of the safety shield. The locking tether of the component extends from one end of the device to the other to prevent distal movement of the safety shield. Can be formed at the end.

[0026] The shield retention indicator may be formed by a hollow cylinder having an annular cylindrical element; The annular cylindrical element is elongated with arcuate extensions or lobes that conform to the geometry of the housing. The shield retention indicator is a slidable, yet form-fitting, hollow cylinder of the longitudinal housing. The shield retention indicator may be received by a body extension. The shield retention indicator has a smooth outer periphery. At its proximal end, the shield retention indicator has a plurality of, preferably four, longitudinally flexible arms each having a proximal free end. The free ends of the flexible arms may be radially The inwardly extending protrusions may be reinforced by short longitudinal chamfered ribs. The distal end of the shield retention indicator may include a circular opening.

[0027] The arms of the shield retention indicator are flexible as described above, so that the safety shield can be secured after use. This reduces the degree of distal movement of the humerus to a certain very limited amount. In addition to reducing movement, these arms also block distal movement of the safety shield, preventing The arm is configured to deflect radially outward relative to the hollow cylindrical body of the longitudinal housing. This provides a very safe lockout after use and prevents easy access to the needle. prevent.

[0028] The outer surface of the shield retention indicator shall be signal colored, i.e., yellow, orange, or red, or The device may have a signal pattern that is clearly visible to the user, thereby enabling drug delivery in accordance with the present invention. The user of the autoinjector, i.e., a doctor or patient, will be asked to consider the operation of the delivery device. or the caregiver can see a signal that the shield retention indicator is clearly visible from the outside through the longitudinal housing. When it is moved to a new position, it can be easily recognized.

[0029] The inner element of the shield retention indicator comprises a first hollow cylindrical portion having a smaller diameter and a second hollow cylindrical portion having a larger diameter. The second hollow cylindrical section may be formed by a stepped tube having an enlarged second hollow cylindrical section with a larger diameter. At its proximal end, the inner element of the shield retention indicator has two opposing proximally extending The flexible longitudinal arm may include a first portion running longitudinally and a second portion The third portion is inclined slightly radially inward, but in the longitudinal direction, further radially than the first portion. At its proximal end, each arm extends radially outward. The retaining projection may have an inclined retaining projection.

[0030] The distal portion of the inner element of the shield retention indicator is approximately the same round as the distal end of the shield retention indicator. The second hollow cylindrical portion may have an end plate having an elongated cross section. is adapted to be received within a circular opening provided at the distal end of the shield retention indicator. can be done.

[0031] To increase the safety level of the device, the device is fitted with a locking ring within the longitudinal housing in the initial position. The locking ring may be provided to lock onto the safety shield during operation. The ring is inserted after the fluid product has been finally dispensed and the automated drug delivery device has been removed from the injection site. The safety shield then covers the needle, blocking distal movement of the safety shield.

[0032] In an initial state, the locking ring may be held by the receiving component, and the locking ring The locking ring engages with the safety shield after the safety shield is pushed distally. When the automatic drug delivery device is removed from the injection site, the safety shield spring provides a spring force to keep the device safe. The locking ring is moved proximally with the shield. Any distal movement of the safety shield relative to the element may be blocked.

[0033] After the plunger is released from the retainer, proximal movement of the safety shield will The shield may be prevented from reaching a predetermined dispensing position. This predetermined position may be the same as the shield retention indicator. This may be, but need not be, the same predetermined position. This allows a safety shield to cover the needle, thus preventing accidental injection rather than wasting the remaining dose. The safety shield may be able to be spontaneously removed and the needle then reinserted. This prevents biasing forces acting on the safety shield from moving the device away from the skin. It can also make it easier for the user to hold the device against the skin.

[0034] The safety shield is secured by the end caps via longitudinal arms against the force of the shield spring. The trigger element may be partially compressed distally into the housing by a longitudinal arm. The trigger element may act as an intermediate element between the trigger element and the shield spring. the distal end of the arm of the safety shield via its protrusion and any clip features; The protrusions can be permanently attached to the ends of the longitudinal arms. In addition, the chamfered protrusions allow each clip to fit within the When the feature is engaged into the through hole or recess, so that in the assembled state, Prevents the arm of the safety shield from separating from the trigger element under axial force. Guide contours on the distal ends of the bars and arms facilitate the assembly process.

[0035] The proximal end of the shield spring may engage the distal portion of the trigger element. The distal end of the shield spring may rest against a peripheral or transverse rib. the distal end of the indicator against the flanged proximal surface of the plate of the inner element of the shield retention indicator. Pressurization may be performed.

[0036] The shield retention indicator with its cylindrical body is The longitudinal arms of the shield retention indicator may receive and surround a spring. The proximal extension may extend through a gap provided between the lateral tabs and / or box-shaped structures. Each of the longitudinal arms may project radially outward from the trigger element. The facing arm is attached to the shield holding indicator so that the protruding portion of the arm engages with the outer circumferential surface of the holder. It may pass through a trigger element.

[0037] The retainer and associated components are secured within the distal end cap, e.g., with an inner peripheral projection. The retainer may be fitted with a hollow cylindrical body and fixedly held within the outer peripheral slot of the retainer. This allows the holder to withstand any axial movement and tilt within the device. can be fixed to.

[0038] The shield retention indicator is a shield spring compressed together with the inner element of the shield retention indicator. and shaft position using the inner arm of the shield retention indicator, regardless of the resulting shaft drive force. This can be reached through a longitudinal notch in the holder and can be held in place by a corresponding The retaining projections are radially engaged behind the lateral projections of the retainer that bridge the notches. Moreover, in this state, the inner side of the arm is radially The outer surface of the plunger, which is arranged in the radial direction, is bent inwardly so that the arms are positioned on the lateral projections. may be used to prevent escape from the holding function.

[0039] The plunger can hold the main spring in a compressed state. The proximal end of the compressed main spring is The proximal end of the plunger may be pressed against the stopper element. The distal end of the main spring is slidably received within the hollow glass body of the syringe. The plunger may project from the retainer and be received within a hollow interior of the retainer supported against its distal end. The plunger may be moved between the flexible arms by engaging the radially inward projections. Therefore, it can be held in its axial position against the driving force of the main spring, and the protrusion The flexible arms engage with through holes provided in the flexible arms. The flexible arm is held in place by contact between the trigger element and the inner circumferential surface of the trigger element. The propeller cannot bend radially outward in response to the driving force of the main spring. The plungers are held by the flexible arms of the retainer and their radially inward projections. .

[0040] Cap Features The present invention relates to an automated drug delivery device for dispensing fluid products, particularly fluid medications. , a longitudinal housing extending along a longitudinal axis and having a proximal end; a distal end opposite a proximal end and a hollow interior; a removable cap attachable to the proximal end of the housing; a syringe assembly disposed in a mounting position inside the housing, the syringe assembly comprising: A syringe assembly having a hollow body and a needle connected to the hollow syringe body, the syringe body containing a fluid product. Swertia japonica and a drive mechanism that can be actuated by a trigger element to initiate dispensing of the fluid product; and The loaded drive mechanism is operable with a safety shield that is movable within the longitudinal housing. Combined, The safety shield extends from the proximal end of the longitudinal housing to cover the tip of the needle. The needle is biased to a protruding proximal position, and the safety shield is biased to a distal position where the needle is exposed for injection. It can be moved to a different position, The removable cap is secured by engagement of a retaining element between the cap and the longitudinal housing. The cap is axially held on the proximal end of the longitudinal housing, and the holding element is configured to hold the cap axially relative to the housing. A longitudinal movement of the cap relative to the housing allows the cap to be removed. Rotation of the cap engages and disengages the cap, and axial movement of the cap relative to the housing provides additional protection to the safety shield. The present invention relates to an automatic drug delivery device supported by a biasing force.

[0041] The removable cap is secured by engagement of a retaining element between the cap and the longitudinal housing. The longitudinal housing is axially held on the proximal end of the longitudinal housing. The longitudinal housing is held by a removable cap. a retaining structure for engaging at least one engagement structure provided on the cap; The engagement structure may include a retaining structure for retaining the removable cap on the longitudinal housing. Such engagement may secure the fit between the cap and the longitudinal housing. It may also enhance sexuality.

[0042] The design of the retention element, e.g., the retention or engagement structure, determines how the cap is removed; Or at least design it to provide a preferred method of removal. Removal of the cap by pulling it out is prevented, so you can just press it down and twist it off. Removal of the cap by pulling it out may also be possible, which typically requires appropriate force. The user may be able to choose between both removal methods. The force required to remove the cap by pulling it should be set at a lower level than the force required to twist it off. That's fine.

[0043] The removable cap has at least one interior surface defining an axially opening receptacle. and an end cap body having an inner ring connected to the end cap body, The inner surface of the removable end cap and the inner ring are adapted to receive the proximal end of the longitudinal housing. This space between the inner surface and the inner ring forms a space for the proximal end of the longitudinal housing. This may provide a secure way for the cap to receive the end. This reduces the risk that the cap may be accidentally removed or dislodged. While the internal ring formation of the present invention may be advantageous, other features provided by the present invention may also be advantageous. You may consider related options.

[0044] To perform a proper retention function, the retention structure is attached to the outer periphery of the longitudinal housing near the proximal end. and at least one protrusion, for example a U-shaped protrusion, that protrudes radially outward. The engagement structure may be formed by a removable recess in the U-shaped projection. The retaining rib may be formed by at least one retaining rib on the radially inner surface of the cap. The retention action between the removable cap and the longitudinal housing is formed on the longitudinal housing. The retaining rib is provided by engaging the retaining rib within the U-shaped projection.

[0045] Also, suitable retention features include at least one engaging longitudinal housing and removable cap. The removable cap may include a mating projection, and the removable cap may be positioned in a locking position relative to the housing in the longitudinal direction. This may also be accomplished by receiving a formation to maintain the

[0046] The longitudinal housing has at least one radius formed on an inner circumferential surface of the proximal end of the longitudinal housing. The inner ring may include a directional inward engagement projection formed on an outer peripheral surface of the inner ring. It may be adapted to engage with at least one corresponding radially outward projection.

[0047] At least one radially inward engaging projection is preferably provided with a chamfer, e.g., a rib. At least one receiving shape may be formed with a chamfered or rounded edge. The structure may be formed by two opposing chamfered projections and one axial projection. The retaining element that axially retains the removable cap on the proximal end of the longitudinal housing comprises: an internal protrusion formed on the proximal end of the longitudinal housing and an internal protrusion formed on the inside of the end cap body; The cap body may include a protrusion, and the protrusion on the inside of the cap body may include a recess, and the inward protrusion may be formed inside the recess. The part is held at the periphery by a chamfered projection.

[0048] The cap of the safety shield can be removed while removing the removable cap, e.g. Once the needle shield is attached to the longitudinal housing, the removable cap is placed over or attached to the proximal end of the needle shield. The proximal contact surface may engage with a proximal front surface of the needle shield or a proximal contact surface formed near the needle shield. It can be a stepped surface or shoulder provided near the proximal end of the needle shield. The drug delivery device includes a proximal end of the longitudinal housing having a removable end cap. It may further be provided that there is engagement on one inner surface and / or at the inner ring.

[0049] The removable cap can be removed by twisting it proximally. formed as a guide surface inclined relative to the longitudinal axis in order to guide along at least a portion of the At least one guide surface or cam path surface may be provided. The guide surface or cam path surface may be disposed on the outer circumferential surface of the inner ring. Rotate or twist the removable cap proximally (longitudinally away from the housing). and a longitudinal axis adapted or inclined to guide the movement along at least a portion of the longitudinal axis. As a further option, the guide surface may be congruently closed on the proximal end of the longitudinal housing. It may be provided as a curved front surface or formed on the inner periphery of the removable cap. and corresponding guide projections that engage the guide surfaces may be provided within the removable cap. It is formed on the periphery or on the front face of the longitudinal housing.

[0050] The safety shield may include a cylindrical and / or ring-shaped hollow body at its proximal end, At least one safety shield projection is provided on the hollow body. The safety shield protrusions limit distal movement of the safety shield relative to the removable cap. The removable cap may be adapted to engage a protrusion or recess in order to limit This allows the safety shield to be specifically designed to withstand an unintentional impact to the safety shield. Typically, after a free fall and subsequent impact with a hard surface, the automated drug delivery device may accidentally That is, the device can be prevented from triggering to begin delivering the drug.

[0051] The removable cap is breakable when attached to the longitudinal housing in its retaining position. The longitudinal housing may be secured by a rupturable seal. An attached sticker that overlaps the outer periphery of the housing and the removable cap. and in the event of fracture at the joint between the longitudinal housing and the removable cap, The equipment may have already been used or, if intact at the joint, may be in its original condition. It may also act as a visible seal to indicate whether the product is in an unused state. The cutoff also requires a certain threshold force when twisting the removable cap relative to the housing. which may be detected by the user.

[0052] The present invention provides a removable cap from an automatic drug delivery device as described herein. A method for removing a To disengage the retaining element between the cap and the longitudinal housing, a retaining element is attached to the longitudinal body. rotating the removable cap; providing a removal force to separate the removable cap from the longitudinal body; To assist in the separation of the removable cap from the longitudinal body, a safety shield is added. and using a biasing force equal to the biasing force.

[0053] The removable cap is positioned such that the retaining element between the cap and the longitudinal housing is disengaged. By rotating the removable cap or housing beyond the cam path, the removable cap or housing moves longitudinally. a part of the body or the removable cap to move the removable cap longitudinally from the body; The force acting on the substrate provides at least a portion of the removal force to separate the substrate from the substrate.

[0054] Once the retaining element is disengaged, the removable cap releases a biasing force acting on the safety shield. A force can be applied proximally and audible or tactile feedback can be provided to the engaging structure. The feedback may indicate that the engagement between the retaining structure and the Due to the initial resistance to twisting of the cap relative to the housing, it is only possible to twist the cap with a sufficiently large twisting force, e.g., by hand. Even if the user provides a sense of motion that overcomes the reaction to the applied twisting force, Once the engagement is disengaged by applying a sufficiently large threshold twisting force, the removal The cap can be rotated further. After a certain level of rotation, the safety seal The axial force acting on the cap is directed proximally away from the housing, supporting the removable cap. This provides a different haptic feedback that the user experiences, which is It may also show the correct way to handle the device.

[0055] When attached to the proximal end of the housing, the removable cap contacts the safety shield, The biasing force that urges the safety shield to a proximal position prevents the cap from being removed. The safety shield may be held in the capped position to aid in removal. The removable cap is secured to the longitudinal housing by engagement of a retaining element between the cap and the longitudinal housing. The cap may not be axially held at the proximal end of the housing, which may be necessary to remove the cap from the housing. The cap is longitudinally movable relative to the housing so as to allow axial movement of the cap relative to the body. Note that the engagement can be disengaged by rotating the

[0056] The capped position of the safety shield is safe when not restrained by the cap. The shield may be biased between a proximal position and a distal position. The shield is held in position within its expected range of motion. The position indicated above is such that further movement against the biasing force is required to move the safety shield to the distal position. It may be that it should be.

[0057] In the capped position, the tip of the needle may protrude beyond the safety shield. The cap holds the safety shield in the capped position, preventing access to the needle. When the cap is removed, the safety shield moves to its proximal position, where it , protruding from the proximal end of the longitudinal housing to cover the needle tip of the injection needle.

[0058] The removable end cap assembly is designed so that the end cap rests on a flat or slightly inclined surface. The arcuate extension or extensions may be formed such that when the body is inserted, the body has a non-circular cross-sectional shape that provides a rocking-resistant shape. The body may be formed to have a cylindrical body integrally formed with extensions such as lobes. The exterior surface may be textured or knurled to improve grip. The exterior surface comprises a number of integrally formed radii extending longitudinally between the proximal and distal ends of the body. The proximal part of the body may be formed by a smooth outer surface. This surface may have an arrow-shaped through-hole, a recess or a protrusion, or a longitudinal direction relative to the housing. The end cap may include other markings indicating the direction of movement to twist and / or push the end cap off. That's fine too.

[0059] The interior of the end cap body is a circular groove forming an axially open receptacle with a smooth receiving surface. There may be an integrally formed inner ring portion adjacent to the receiving portion. The ring portion may include a substantially flat distal-facing surface. Between the inner circumferential surface, one or more opening cross sections and one or more connections connecting both elements The ring portion may be one or more rings extending radially outwardly in the cross section of the opening. On either side of the protrusions, the outer surface of the ring portion may be provided with protrusions a sloped elevation formation having a distal most position close to the tip and sloping distally to match the tip; It can be equipped with:

[0060] The outer periphery of the ring portion is provided with a chamfer or a radius or other chamfer that forms a receiving space therebetween. The receiving space may have two protrusions, one of which is hidden when viewing and handling the device. and a protrusion formed on the inner circumferential surface of the longitudinal housing on its proximal end to receive and fix the protrusion. This allows for a hidden connection between the housing and the removable cap. Furthermore, re-capping the autoinjector is not possible. can be obstructed or avoided.

[0061] On its radially inner surface, the ring body has one or more opposed protrusions projecting radially inward. These protrusions may be formed on the outer periphery of the proximal end of the safety shield. A corresponding radially outward projection is provided for interaction with and locking against the corresponding radially outward projection.

[0062] A removable end cap body near its proximal end is disposed opposite the connector and the connector. The end cap may be faced with two annular arches fixed to the inner peripheral surface of the end cap body using connecting ribs. .

[0063] The end cap covers provided for the removable end cap bodies are slightly tilted. a proximal end cap portion having an angled projection and having the same base surface as the end cap body; The annular cylinder may extend from the proximal face of the end cap portion. It may have a plurality of longitudinal ribs on its outer circumferential surface that project beyond the distal end of the annular cylindrical body. The free ends of these longitudinal ribs must have snap-fit ​​projections projecting radially outward. As many as necessary can be provided, which correspond (annular) within the removable end cap body. The interior of the annular cylinder has a chamfered radial groove running into the inner cylinder. The cylindrical portion may include a rib extending therethrough, which is also integrally formed with the distal face of the end cap portion. the distal front surface of the arrangement formed by the body, the rib projections, the radial internal ribs and the internal cylindrical body; can form a conical or frusto-conical profile.

[0064] gripping element The syringe assembly may include a preferably rigid needle shield. A needle shield may be attached to the proximal end of the syringe body, preferably along with its sharp needle tip. The needle may be covered. The inclusion of a needle shield keeps the needle and fluid product, e.g., fluid medication, clean and It can mean keeping something sterile.

[0065] In addition to the covering and feedback functions of the removable cap, The cap may have another purpose for the device. The removable cap may also serve as a needle seal. When the removable cap is removed, the rigid needle shield may be engaged by the user. The needle is grasped and removed together with the cap so that the needle does not have to come into direct contact with the rigid needle shield. Since the needle and syringe glass are sensitive components, rigid needle shields may be used. Handle the syringe with care both during assembly and removal from the syringe assembly. The removable cap must be designed to engage the needle shield with its outer contour. The device may include a flexible gripping element for this purpose.

[0066] The present invention provides an automated medication delivery device for dispensing a fluid product, comprising: The nozzle extends along a longitudinal axis and has a proximal end near the dispensing location, a distal end opposite the proximal end, and a center a longitudinal housing having a hollow interior; a removable cap attachable to the proximal end of the housing; A hollow syringe body is disposed at a mounting position inside the housing and is connected to the hollow syringe body containing the fluid product. a syringe assembly having an attached needle; a drive mechanism that can be actuated by a trigger element to initiate dispensing of the fluid product; and the drive mechanism is operably coupled to a safety shield movable within the longitudinal housing; The safety shield extends from the proximal end of the longitudinal housing to cover the tip of the needle. The needle is biased to a proximal position where it projects, and the safety shield is biased to a distal position where the needle is exposed for injection. It is movable to The syringe assembly includes a needle shield secured to the proximal end of the hollow syringe body and covering the needle. , The removable cap allows you to remove the needle shield. a flexible gripping element for engaging the needle shield on its outer periphery for removal; The gripping element has a diameter greater than the proximal end of the safety shield. do.

[0067] By providing a flexible gripping element having a diameter larger than the proximal end of the safety shield, To allow for the use of longer flexible gripping elements such as legs or lobes with lower assembly forces. The gripping element has a larger diameter than the proximal end of the safety shield, so that the gripping element The element may not extend into the safety shield, which can provide packaging advantages. Initially equipped with a removable cap on the device, the safety shield is The needle shield is urged to extend beyond the proximal end of the safety shield. The sensor may be held in a position such that the sensor is in a fixed position.

[0068] The needle shield may engage the hollow conical glass portion with the insert. For safe and sterile reception, the needle shield includes a flexible insert that receives the needle. The flexible insert safely covers the needle and is contained within the syringe and needle. The needle shield may include a tubular member containing a flexible insert. The outer surface of the tubular member may have lateral gripping ribs and / or alternatively may simply be relatively flexible. The gripping ribs or flexible outer surface may be engaged by a gripping element. stomach.

[0069] The needle shield may be intended to be gripped on its outer periphery. For example, the flexible grip element may be formed by at least one protrusion or recess for engaging the flexible grip element. The flexible gripping element may include at least one gripping structure on a peripheral surface contour of the needle. Alternatively, the gripping element may be rigid and configured to engage the outer contour of the handle. This can be achieved by engaging the softer outer surface of the insert of the needle shield. .

[0070] The flexible gripping element may be fixedly mounted or axially disposed within a removable cap. and / or may be arranged with a radial gap. The floating arrangement with axial clearance in the cap allows the gripping element to grip the needle seal during assembly. Contact with the needle shield promotes bending of the rim. The gripping element is typically attached to a rigid needle shield. It may be designed to reduce the axial force applied to it, which minimizes collapse and reduces the risk of pre-filling. This is to ensure that the integrity of the container closure of the filled syringe is maintained. If the needle shield is broken, the deflection force increases and the axial force on the needle shield can be much higher. Allowing for small clearance float and having edges that contact the gripping elements reduces assembly forces The gap is a design feature that helps maintain the integrity of the container closure. Rotation of the gripping element may also be permitted during release, which also reduces the likelihood of coring. This is an advantageous feature.

[0071] The flexible gripping element includes a flexible washer having a mounting portion that mounts within the removable cap. The flexible washer may be formed by a mold component, such as a blade washer. The flexible gripping elements, such as at least one of The blade washer may also include one or more gripping arms or lobes. It may have a frusto-conical shape.

[0072] The flexible gripping element may have a periphery, for example a circular periphery that surrounds the ring-shaped body. The flexible gripping elements are formed integrally with the ring-shaped body and include at least two radially inwardly extending The ring-shaped body may include lobes or arms that extend radially outwardly from the circular inner gripping feature. You may do so.

[0073] The flexible gripping elements may have a flat or frusto-conical shape and, in use, Alternatively, the lobes may provide axial spring action and / or gripping force, i.e., gripping the exterior surface of the rigid needle shield. Such a gripping force may be adapted to bend in a radial direction. Biasing the bent gripping arms toward a center position and thus toward the rigid needle shield It may also be a force that

[0074] The external geometry of the gripping elements may be circular or other suitable for the available assembly load or packaging space. The gripping element may have any other geometric shape. There may be lobes that overlap, and the blade geometry may be adjusted to accommodate certain insertion forces during assembly, and Force from the rigid needle shield when the removable cap is removed from the longitudinal housing The gripping element may be of any type to achieve the function of holding the part. It may be advantageous to form ribs along the periphery of the gripping element. This involves rotating the gripping element inside the removable cap during cap removal. Simply rotate the removable cap and pull the gripping element longitudinally. If only one of the two is present, the inhibiting condition known as coring can thereby be removed. Coring, which is not shown, is not an example of a prior art technique where the material of a rigid needle shield is attached to the needle of a syringe assembly. This occurs when the wheel rotates around the hub. Coring then occurs when the rubber is accidentally removed. It is possible to leave a plug inside the needle, which can cause a blockage that stops the device from functioning properly. This is avoided altogether to reduce the

[0075] The removable cap includes a proximal cap that can be fitted onto or inside the removable cap. The removable cap may include a cap cover, and the flexible gripping element may be formed on or within the removable cap. The receiving structure is disposed in the mounting space between the receiving structure and the proximal end cap cover.

[0076] A rigid needle shield is preferred because it provides minimal resistance axially applied by the gripping elements during assembly. Alternatively, it may be engageable by a gripping element in the range of 1N to 50N.

[0077] The present invention, as claimed, is a method of assembling an automatic drug delivery device. hand, Power unit subassembly, syringe assembly, syringe holder, and proximal subassembly providing an assembly, The proximal subassembly extends along a longitudinal axis and has a proximal end near the dispensing location, a longitudinal housing having an opposing distal end and a hollow interior, and a proximal end attached to the housing; a removable cap, the removable cap including a flexible gripping element; The subassembly further includes a safety shield, the flexible gripping element extending from the proximal end of the safety shield. has a larger diameter than The first syringe assembly is formed with a hollow syringe body and a hollow syringe body containing a fluid product. a syringe assembly secured to the proximal end of the hollow syringe body and covering the needle; , equipped with a needle shield, The power unit subassembly is actuated by a trigger element to initiate the dispensing of the fluid product. and providing a drive mechanism that can be actuated by the Mounting a syringe assembly in a syringe holder; The needle shield is attached to the flexible gripping element such that the flexible gripping element engages the needle shield at its outer periphery. the syringe assembly and syringe holder to the proximal subassembly so as to extend through the element; Inserting it into a power supply unit subassembly such that the drive mechanism is operably coupled to the safety shield; and attaching the proximal subassembly to the proximal subassembly.

[0078] The removable cap is fitted with a proximal cap cover. the flexible gripping element may include a receiving portion inside the removable cap and a proximal end It is disposed in the mounting space between the cap and the cover.

[0079] The gripping element may be positioned such that the needle shield is not aligned, e.g., in the removable cap. Asymmetric gripping forces may be provided so that the clamping members are biased axially out of alignment within the clamp. This may be achieved in a variety of ways, for example, one or more lobes of the gripping element may be , such that there is an asymmetric force load on the rigid needle shield when engaging the rigid needle shield. The other lobes may have different shapes and / or lengths. This causes a tilting or rotating action so that the shield is deflected from its original position. Once the cap is removed, it is difficult to re-capping it on the housing, i.e. Reattaching the cap can be prevented or avoided.

[0080] Platform Features The present invention provides an automated medication delivery device for dispensing a fluid product, comprising: The nozzle extends along a longitudinal axis and has a proximal end near the dispensing location, a distal end opposite the proximal end, and a center a longitudinal housing having a hollow interior; a removable cap attachable to the proximal end of the housing; A hollow syringe body is disposed at a mounting position inside the housing and is connected to the hollow syringe body containing the fluid product. a syringe assembly having an attached needle; a drive mechanism that can be actuated by a trigger element to initiate dispensing of the fluid product; and the drive mechanism is operably coupled to a safety shield movable within the longitudinal housing; The safety shield extends from the proximal end of the longitudinal housing to cover the tip of the needle. The needle is biased to a proximal position where it projects, and the safety shield is biased to a distal position where the needle is exposed for injection. It is movable to The longitudinal housing receives the syringe holder and defines a predetermined radius of the syringe holder within the longitudinal housing. and providing an internal receiving component secured thereto to provide an axial location; The syringe assembly is a first syringe assembly and is longitudinally held by a first syringe holder. a first syringe holder received within the longitudinal housing and positioned between the longitudinal housing and the syringe assembly; Provides a joint, The longitudinal housing and receiving component hold the second syringe holder and the second syringe assembly. the second syringe assembly is sized and configured to receive the first syringe assembly. Also provided is an automated drug delivery device having a different diameter than the assembly.

[0081] A device in which a single component, in this case the syringe holder, can be replaced to accommodate different syringe diameters. This feature allows the device to be used as a platform device for various syringe assemblies. The longitudinal housing and receiving component may be used to hold a second syringe holder and a second syringe. and a second syringe assembly. The assembly has a larger diameter than the first syringe assembly.

[0082] The internal receiving component may be fixedly mounted to the inner periphery of the longitudinal housing, A predetermined radial and axial position of the syringe holder within the body may be provided. The receiving component may be integrally formed within the housing with its proximal end. Alternatively, the receiving component may be a small, fixedly mounted component on the interior surface of the longitudinal housing. It may be formed as at least one separate piece.

[0083] By using the syringe holder, the syringe holder and syringe assembly In the next assembly step, it is sometimes possible to prefabricate the subassembly. The subassembly can be used and mounted within a longitudinal housing. Prevent the glass bodies of the assembled jars from being directly handled during the assembly process. Instead, use syringes. The holder already covers at least a portion of the glass body of the syringe assembly and holds it during assembly. Furthermore, the syringe holder according to the present invention is able to withstand the forces acting on the syringe assembly. and provides for transmitting these forces to the housing, so that stress acting on the glass body is avoided or reduced. The amount of heat generated can be at least substantially reduced.

[0084] The receiving component is shaped as an annular member that receives the proximal end of the syringe holder with its inner circumferential surface. The outer circumferential surface of the annular member may be longitudinally bounded by at least two interconnecting arms. The receiving component may be attached to the inner circumferential surface of the longitudinal housing. The arm is adapted to move any of the receiving structures against the housing under the axial load acting on it during operation. It should be made of a solid structure with sufficient wall thickness to avoid any unintended movement. This can be done.

[0085] A syringe holder may further be provided apart from its proximal end, preferably on its distal end. At least one contact structure contacts the inner circumferential surface of the longitudinal housing. The projectile holder is further provided with two separate axial locations, i.e., receiving structures, within the longitudinal housing. The syringe holder can be supported on its proximal front end by a contact structure. Provides a stable position for the syringe assembly within the housing.

[0086] The contact structure comprises two opposing support arches extending radially from the distal end of the syringe holder. The recess between the two arches may be formed by a trigger mechanism or the like, e.g. To guide further functional components of the longitudinal arms of the safety shield as discussed in the document. The two longitudinal arms are placed in the syringe holder between the support arches. It may be guided through a recess formed therein.

[0087] As described above, the drive mechanism may include a plunger, the plunger being closer to the drive spring. The plunger may be biased in the forward direction. The syringe holder may act on the fluid product contained within the syringe body. The syringe body may receive an axial force exerted on it by the plunger and transmit that force to the longitudinal housing. You may do so.

[0088] The syringe holder is configured to hold the syringe glass near its proximal end using at least two resilient arms. Specifically, the syringe holder may be configured such that the resilient arms are slightly resilient during assembly. The syringe is slightly bent and formed radially around the needle hub of the syringe glass body on a radially stepped surface. to engage the glass syringe body, and to grip around the proximal front shoulder of the glass syringe body; may be adapted.

[0089] For different pre-filled syringes with different fluid product volumes, identical syringes according to the present invention can be used. In order to provide the possibility of using one device, i.e., different predictions according to another aspect of the present invention. To provide a platform device that can be used for the size of the syringe filled, The holder may be provided in different sizes to accommodate different sizes of syringe bodies. This allows the syringe holder to receive different syringe sizes and accommodate these different syringe sizes. The dimensions can be adjusted according to the present invention without the need to modify the longitudinal housing or any of its other components. It can be provided in different configurations for accommodation within the device.

[0090] The present invention also relates to a syringe holder for an automatic medication delivery device as described herein, The syringe holder is adapted to receive the syringe assembly within the longitudinal housing, and the syringe The holder provides an interface between the longitudinal housing and the syringe assembly, the longitudinal housing comprising: an inner periphery of the longitudinal housing that provides a predetermined radial and axial location of the syringe holder within the longitudinal housing; The syringe holder includes a receiving element that is fixedly mounted to a surface, and the receiving element receives the syringe holder with its proximal end. The data is received within the domain component.

[0091] The syringe holder may receive the syringe radially or axially. It may form part of an assembly or act as a joint, spacer, or adapter. Often, various combinations of syringe bodies and needles are available for use with particular automated drug delivery devices. Specifically, the syringe holder is the only component that can be changed / added. to receive a syringe having a second outer dimension smaller than the first outer dimension. A device adapted to receive a syringe body (with or without a syringe holder) having an outer dimension of 1. The outer dimension of the syringe body may be a diameter or a length. That's fine.

[0092] The syringe holder is a contact point where the syringe assembly interacts with other parts of the automated medication delivery device. The syringe holder may be positioned to provide a point, joint, or attachment point. The contact, junction, or attachment point of the syringe assembly may not be a contact, junction, or attachment point of another syringe assembly. A syringe assembly that does not require a syringe holder, or a different syringe holder, In this way, the automatic drug delivery device can Easy to receive and interact with syringe assemblies of a first size and shape without a syringe holder may be designed to accommodate different injections and still be able to do so through the use of an appropriate syringe holder. The device can receive and interact with the vessel assembly.

[0093] The contact, joining or attachment points may be provided on any suitable portion of the syringe holder. The contact, joining, or attachment point may be one or more flanges, ridges, or a syringe holder. The at least two extensions from the body of the There may be contact points, joints, or attachment points that run along the length of the syringe holder. One contact, joining, or attachment point may be at one end of the syringe holder. and one may be placed at the opposite end of the syringe holder. The syringe may include a first joint that substantially replicates the flange of the syringe.

[0094] The ability of automated drug delivery to receive and interact with a variety of syringe assemblies is a key advantage of the design of a single device. The syringe can be used to administer different volumes of medication from different syringe bodies, possibly different volumes. Multiple syringe holders are available to ensure that the appropriate syringe holder is compatible with a particular syringe body and needle. The combination may be provided on the device so that it can be selected for use with the combination.

[0095] Accordingly, the present invention is an automated drug delivery device for dispensing fluid products, particularly fluid medications. There was, The nozzle extends along a longitudinal axis and has a proximal end near the dispensing location, a distal end opposite the proximal end, and a center a longitudinal housing having a hollow interior; a removable cap attachable to the proximal end of the housing; a syringe assembly disposed in a mounting position inside the housing, the syringe assembly comprising: A hollow syringe body and a needle coupled to the hollow syringe body, the hollow syringe body containing a fluid product. a syringe assembly; a drive mechanism that can be actuated by a trigger element to initiate dispensing of the fluid product; and The loaded drive mechanism is operably coupled to a safety shield movable within the longitudinal housing. R, The safety shield extends from the proximal end of the longitudinal housing to cover the tip of the needle. The needle is biased to a proximal position where it projects, and the safety shield is biased to a distal position where the needle is exposed for injection. It is movable to The syringe assembly further includes a syringe holder that supports the syringe body within the housing. The present invention further provides an automatic drug delivery device.

[0096] The present invention provides a method for manufacturing an automatic drug delivery device, comprising the steps of: providing a housing, a drive mechanism, and a safety shield; providing a hollow syringe body and a needle coupled to the hollow syringe body; providing a projectile body containing a fluid product; Determine whether the syringe holder is required to support a hollow syringe body and needle combination. and If necessary, select a suitable syringe holder and assemble the syringe holder, hollow syringe body, and syringe. Producing a syringe assembly including a needle; A drive mechanism, safety shield and syringe assembly are assembled to produce an automated drug delivery device. and inserting the housing into the housing.

[0097] A plurality of syringe holders may be provided. The syringe holders may be configured in different geometries. , may be adapted to receive different syringes with different volumes of medication, Regardless of the syringe, each syringe holder is mounted within the same housing of the automated drug delivery device. In other words, the syringe holder according to the present invention is adapted to fit in a syringe holder. Easy and consistent assembly of different syringe sizes (e.g., 1 ml and 2 ml) Different geometries can be configured differently to receive the syringe in a manner that securely holds it within the housing. In particular, different syringe holder geometries can be provided without further modification. This is a platform system, i.e. drug delivery devices with the same overall dimensions and assembly requirements for different dosages and drugs Alternatively, the plunger can be replaced and a matching member can be attached to the proximal plunger end. For example, there may be a need to accommodate syringes and / or syringe stoppers of different bore diameters. There is a saying.

[0098] The syringe holder includes at least one flexible portion that can be elastically deformed in a circumferential or radial direction. This allows the syringe holder to receive the syringe body and / or the injection needle therein. The device may be resiliently held in place.

[0099] The syringe holder may include a longitudinal body, the longitudinal body having a proximal end and / or a distal end. At the distal end, a pre-filled syringe is introduced into the syringe holder in a radial direction perpendicular to the axial direction. The U-shaped element is formed of a rigid, substantially inelastic U-shaped element so that the U-shaped element can be

[0100] The syringe holder comprises two longitudinally extending syringe barrels connected by at least one flexible V-shaped section. The flexible V-shaped portion may be formed by a shell, and the flexible V-shaped portion may provide circumferential flexibility to the syringe holder. The shells can resiliently move apart when the syringe is introduced.

[0101] The syringe holder has a radial support for supporting the syringe body in the axial direction, specifically in the proximal axial direction. The syringe holder may include a radially extending inner projection that is in contact with the proximal shoulder of the syringe body. may be supported.

[0102] The syringe assembly includes a needle sleeve, possibly a rigid sleeve, secured to the proximal end of the hollow syringe body and covering the needle. The syringe holder may include a radially inner projection that connects the syringe body and the needle shield. The syringe assembly may be radially received such that it is positioned between the radially inwardly projecting portions. The raised portion may have a smaller diameter than the rigid needle shield.

[0103] The syringe holder may have one, two or more bends that can bend radially and / or circumferentially. The flexible portion may have an upper flexible zone or portion, in particular a z-shaped flexible portion. The / zone supports the syringe axially once inserted distally and received therein. While being able to maintain the load, it is also possible to absorb energy shocks and prevent misalignment of the assembly. Therefore, some axial movement is possible.

[0104] The drive mechanism provides initial positioning through engagement of radially inward projections with slots in the plunger. The plunger may be held in place by a suitable means. The plunger may be used to accommodate different syringe sizes or different filling The retaining slots may be provided with a plurality of retaining slots adapted for filling. The plurality of retaining slots may be provided with a plurality of retaining slots adapted for filling at different axial positions. The one or more retention slots may engage with and hold the drive mechanism. This allows the starting position of the plunger to be determined relative to the movable stopper or other feature of the syringe assembly. By providing slots with different longitudinal positions, the slots may The plunger can be engaged with the drive mechanism at different longitudinal positions during manufacture. The retainer may include longitudinally and circumferentially offset retention slots. This facilitates manufacturing since the slot only needs to engage with the drive mechanism in a specific rotational direction. By circumferentially offsetting the plunger, the longitudinal slot at the desired position is driven. The drive mechanism rotates the assembly to the correct orientation to align with the mating components. The plunger can then be aligned with the drive mechanism. The slots can be assembled to the drive mechanism by linear motion to engage. If the assembly is not misaligned, the required linear and rotational motion may be combined. , which may result in assembly errors.

[0105] The plunger may include alignment markers to facilitate rotational alignment. The alignment marker may be any suitable marker, for example a visible mark, for example printed on the plunger. or etched marks, or the markers may be physical markers, e.g. The alignment marker may be a protrusion or groove that can be engaged by the stand-up device. The alignment slot may be at the end of the casing. The alignment slot may extend across the entire diameter of the end of the cylindrical plunger. , a stopper or plunger head that engages the end of the plunger to facilitate assembly You may do so.

[0106] The plunger head of the plunger rod is different from the diameter of some stoppers. The plunger adapter may include an adapter to increase the diameter of the plunger. Like syringe holders, various options include multiple plungers. It can mean available for assembly into a particular device.

[0107] This is because the method for manufacturing the automatic drug delivery device described above is Determine what is needed for a particular syringe body and needle combination and select the appropriate process to assemble the device. This means that the method may further include the step of selecting a random number. Since it does not have to be based on size, the manufacturing method is Determine which of the multiple plungers is required for use with the selected syringe assembly. determining the and b. assembling the selected plunger into the device.

[0108] If the plunger has longitudinally offset slots for engaging the drive mechanism, The method for manufacturing an automated drug delivery device includes determining which longitudinal slot is located in a particular syringe assembly. Determine whether the drive mechanism should engage the appropriate longitudinal slot during assembly. If the longitudinal slots are circumferentially offset, The method includes the step of rotating the plunger to a predetermined rotation relative to the drive mechanism prior to assembly. It may further include:

[0109] As noted above, multiple plungers and syringe holders may be provided for a particular device design. can be used to deliver medication from multiple syringe bodies having different sizes and fill volumes. A platform device can be provided.

[0110] Accordingly, the present invention provides a syringe for delivering medication from a hollow syringe body having a needle attached thereto. A parts kit for assembling an automatic drug delivery device, the hollow syringe body is for dispensing a fluid product. The kit includes a standard housing, a standard drive mechanism, a standard safety shield, multiple syringe holders, and and / or a plurality of plungers, which is determined by the combination of parts to form a particular hollow syringe body and injection syringe. that can be assembled together to produce an automated drug delivery device suitable for injection needles This "platform" construction means that the device requires only one or two parts to be changed. This allows for use with syringe body / needle combinations of different sizes / shapes / fill volumes. It can be adapted for use.

[0111] The present invention provides a kit of parts for assembling an automatic drug delivery device as described herein. The kit includes a power supply subassembly, a first syringe assembly, and a second syringe assembly. and a proximal subassembly, The proximal subassembly extends along a longitudinal axis and has a proximal end near the dispensing location, A longitudinal housing having opposite distal ends and a hollow interior, and a mounting attachment attached to the proximal end of the housing. Includes a removable cap The first syringe assembly is formed with a hollow syringe body and a hollow syringe body containing a fluid product. a syringe needle, The second syringe assembly has a diameter greater than the diameter of the syringe body of the first syringe assembly. and a needle coupled to the hollow syringe body containing the fluid product, The power unit subassembly is actuated by a trigger element to initiate the dispensing of the fluid product. a power supply unit subassembly including a drive mechanism that can be actuated by a first injection; a syringe assembly, a second syringe assembly, and a proximal subassembly; a first syringe for providing an interface between the longitudinal housing and the first syringe assembly; A holder and a second syringe for providing an interface between the longitudinal housing and the second syringe assembly; a holder; The assembled automated drug delivery device consists of a power unit subassembly and a proximal subassembly. a syringe holder, a first syringe assembly, and a second syringe assembly; and a second syringe holder.

[0112] The present invention provides a method for assembling an automatic drug delivery device using a kit of parts as described above. 1. A method comprising: a first syringe assembly and a first syringe holder, or a second syringe assembly and Choose one of the two syringe holders, Loading a selected syringe assembly into a selected syringe holder; placing a syringe and a syringe holder in the proximal subassembly; and assembling a power unit subassembly onto the proximal subassembly. A method is also provided.

[0113] As discussed herein, a syringe holder receives and holds a pre-filled syringe within a housing. The syringe holder has the purpose of maintaining the syringe without the need to change other components of the subassembly. The syringe is adapted to receive different types of syringes with different volumes of medication without the need for a separate syringe. Therefore, different syringe holders should provide compatibility with different types / volumes of syringes. .

[0114] The syringe holder may include a longitudinal body. At its proximal end, the syringe holder has a substantially The U-shaped element may be formed of rigid, inelastic U-shaped elements that are open in one radial direction. This rigid U-shaped element at its proximal end may be reinforced by parallel circumferential ribs. On its proximal front face, the U-shaped element may be provided with a transverse rib or protrusion. Additionally, the syringe holder may comprise a substantially rigid, non-resilient, similar U-shaped element. The letter-shaped elements may be reinforced with peripheral ribs that face radially outward at opposing locations. The rigid U-shaped element may comprise two possibly substantially rigid longitudinal cutouts. Each of the connecting arms may extend linearly. The syringe holder includes a radially inwardly projecting projection for releasably retaining the syringe within the syringe holder. the arms may include protrusions, the arms being deformable to allow the syringe body to pass between the protrusions. The inner surface of the projection is contoured to allow the syringe body to be placed and held therein. That's fine.

[0115] a syringe holder that holds a pre-filled syringe assembly when placed within the longitudinal housing; is positioned so that any protrusions engage with corresponding notches in the double ring structure. The syringe holder may be suitably secured by a ring structure or a double ring structure within the longitudinal housing. It may be positioned in an axial and rotational position about the longitudinal axis.

[0116] According to some examples of syringe holders, the syringe holder is held by a plurality of longitudinal shells. The shell can be formed with longitudinal cuts between them. The shell can be formed with flexible V-shaped sections. The distal and proximal regions can be connected to each other, and the flexible V-shaped portion can be attached to the syringe holder. provides circumferential flexibility to the syringe so that the shell can move elastically apart as it guides the syringe. The syringe holder is provided with a locking mechanism for securing the syringe holder within the housing of the autoinjector. The stent may further include radially outward protruding structures near its distal end and its proximal end.

[0117] The internal radial projections, once distally inserted and received within the syringe holder, A syringe may be formed in both shells to provide axial support.

[0118] Alternatively, the syringe holder may include a hollow cylindrical receiving tube with a distal end and a proximal end. As with other examples described herein, this syringe holder is designed to be used for self-injection. It may also include radially outwardly projecting structures for retention within the launcher housing.

[0119] Near its proximal end, the syringe holder may include one or more double Z-sections, The z-section includes angled flexible arms interconnected by a peripheral rib. The syringe holder includes a radially inward projection that prevents the syringe from being pushed out once the syringe is in the distal direction. When inserted from either side and received therein, both flexible double Z-sections provide axial support. In this example of a syringe holder, the syringe is placed in a hollow cylindrical receiving The syringe is pushed into the tube from its distal end with a small amount of radial play. Due to the elastic flexibility of the two double Z-sections, the arms are The peripheral ribs are slightly bent to move radially outward.

[0120] The syringe holder examples described herein provide some radial or circumferential flexibility. The syringe has a circumferentially closed structure with features that allow the pre-filled syringe to be inserted. It can be easily assembled with the syringe holder. The syringe does not deform radially outward during assembly. The syringe assembly is simply held in place by a flexible element that fits over the syringe assembly. can be balanced both radially and axially. The syringe holder has a robust structure with a rigid shell or cylindrical receiving tube.

[0121] The plunger may be formed by a longitudinal cylindrical hollow element, The element has a plunger head at its proximal end. The plunger head has a front and a lateral slot. The front surface may include small cylindrical through holes. Optional transverse slots and The front face with a cylindrical through-hole can, if necessary, interact with a corresponding large stop, for example For syringes with larger bore diameters, a larger diameter plunger head element may be mated or This additional enlarged plunger head feature allows for larger injections. It can be used to suit smaller syringes, e.g., 2.25 ml fluid volume. Syringes, e.g., suitable for 1 ml fluid volumes, may include an enlarged plunger head element or features are omitted and the plunger has a simple parallel cylindrical shape at its proximal end.

[0122] At the center of the plunger, a pair of opposing rectangular through holes are provided in the wall of the hollow element. A single through hole may be used rather than a pair of through holes or slots being required. Note that the plunger can be adjusted to accommodate different syringe sizes or drug loads. It has additional through holes or pairs of through holes that match the through holes at different axial positions that can be adapted to the filling volume. At the distal end, the hollow element may have a longitudinally approximating circular opening for receiving the drive spring. The proximal end of the hollow element may include an end engaging stop as discussed above. The plunger may include a spring or plunger head and may include a rotational alignment feature.

[0123] The retainer may act as a control member for multiple control functions of the power supply unit. The holder may be formed from a hollow cylinder. On two opposite sides, the cylinder has may include a U-shaped notch that forms a longitudinally flexible arm. may be integrally connected at its distal end to the hollow cylinder. At its proximal end, the flexible arm is a chamfered feature projecting from the radially outward projection and the opposite side, i.e., the radially outward projection. The interior may be provided with corresponding chamfered features projecting radially inward. , the cylinder is rotated by 90° relative to the flexible arm formed by the notch. Two opposing longitudinal notches may be provided. The longitudinal notches may be U-shaped notches. or may extend further distally. In an area of ​​about one-third of the longitudinal length of the notch, the cylinder has a transverse bridging These laterally bridging protrusions may include following protrusions having the same peripheral shape. The proximal end is then further approached by additional protrusions.

[0124] At its proximal end, the barrel of the retainer is integrally formed with the barrel and faces the proximal front surface of the hollow barrel. The flexible arms may include a plurality of flexible arms that are angled relative to one another. The ring-shaped head can be connected to a cylindrical portion and two opposing The head may be formed as a bushing with a proximal arcuate projection. The flexible arm can be integrally formed with the arm or rigidly attached to the arm, for example by means of an intermediate connecting ring. The conductors may be formed as separate pieces connected to each other.

[0125] The flexible arm allows for some tolerance and compensation for different syringe sizes. Additionally, these flexible arms can be used to hold the syringe in a generally fixed position. By acting on the distal end, the biasing element biases the syringe axially in the proximal direction. The retainer and associated components are positively biased distally.

[0126] At its distal end, the cylindrical body of the retainer can be formed with a circumferential groove. The distal end has a central opening. The cylindrical body may have a distal end surface that is circumferentially grooved with the distal end surface at its interior near the distal end. The longitudinal section may have an internal guide rib running axially or longitudinally between the longitudinal section and the The cylinder is positioned within the confines of other system components that are coaxially arranged or connected to the holder. The diameters may vary depending on the size of the diameters to be assembled. .

[0127] Additionally, the safety shield is assembled with a removable cap at the axial position. Specifically, this prevents unintended distal movement, i.e., the device This is to avoid the case where the device falls and experiences a shock when it hits the ground. a protrusion formed on the outer circumferential surface of the cylindrical body at the proximal end of the safety shield; and a removable cap. This is achieved by the engagement between two protrusions formed on the inner peripheral surface of the inner ring portion. The protrusion thereby contacts a removable cap attached to the housing. Any axial movement of the safety shield in a distal direction relative to the housing can be blocked.

[0128] At the distal end, the distal end cap is secured and sealed to the longitudinal housing by a snap-fit ​​arrangement. The distal end cap can be attached to the distal end cap by a protrusion formed on the outer peripheral surface of the skirt portion. The housing engages with a through hole formed in the distal end of the housing.

[0129] Moreover, in the assembled state, the syringe can be maintained in the syringe holder, The syringe holder is received within the ring structure of the housing. The lateral projections can be positioned relative to the housing using the respective notches. The syringe holder may be fitted with a U-shaped element, and a further protrusion may be fitted to the hollow provided by the U-shaped element of the syringe holder. The syringe may protrude into the space. The syringe may be inserted into the syringe holder before assembly into the housing or after injection. After assembling the syringe holder into the housing depending on the syringe geometry, Any U-shaped element of the syringe holder may be rigidly attached to the syringe holder. and that the rigid needle shield can pass through and will not bend during syringe assembly or actuation. The syringe may be held in a rotating manner within the syringe holder or may be freely rotating. Note that it is possible to

[0130] Assembling the syringe inside the device can be difficult due to glass breakage and inspection of the final position. Side loading of the syringe into the syringe holder can cause problems. Better control and access to features can be achieved. Assembly may be performed by dimensional and force control and inspection. stomach.

[0131] Furthermore, the syringe is inserted into the syringe holder via the syringe flange using the head of the holder. The cone of the housing can be pressed proximally against the stepped ring structure, once the power supply unit is When fully assembled with the knit, the flexible arms of the holder secure the syringe to the syringe holder. A spring force is applied axially in the proximal direction to maintain and thereby position the catheter in place within the catheter. It acts as an axial biasing means.

[0132] Further features The syringe assembly is formed with a hollow syringe body containing a fluid product and a hollow syringe body. The term hollow syringe body includes a hollow cartridge or other hollow body. In the hollow body, a piston or a movable stopper is provided from which the fluid flows through an outlet. It is understood that the variable volume chamber can be moved to create a variable volume chamber that can be evacuated. The outlet may include an integral needle, such as the needle found on a fixed needle syringe, or The syringe needle may be connected to the hollow body by another means such as a luer lock, a threaded connection or other suitable connection. The outlet from which fluid can be discharged may be coupled to, for example, For example, it can be produced by the back of a needle piercing the membrane.

[0133] The housing has a non-circular cross section in at least a portion thereof to provide an anti-vibration function. The housing may be formed in whole or in part from an opaque or transparent material. stomach.

[0134] The fluid product is typically a pharmaceutical composition / formulation suitable for parenteral administration to a human or animal subject. The pharmaceutical composition / formulation may be a biological drug, such as a low molecular weight compound and / or a recombinant product. The pharmaceutical composition may contain one or more pharmaceutically active agents, including pharmaceutical products. Examples of pharmaceutically active agents include antibodies (whole and nucleic acid molecules, including nucleic acids, polypeptides / peptides and their derivatives, and nucleic acid molecules. The molecule is part of a combination with a delivery vehicle such as a vector, a viral particle, and optionally a lipid. Nucleic acids and polypeptides / peptides may be produced by biological processes or synthetically. In one example, the fluid product may contain secukinumab, canak inumab), bimagrumab, omalizumab, tesidormab tesidolumab), iodelcizumab, elgemtumab, Lacnotuzumab, ofatumumab, ligelizumab lizumab, ranibizumab, brolucizumab and iana The present invention includes a pharmaceutical active substance selected from ianalumab.

[0135] The present invention relates to an automated drug delivery device for dispensing fluid products, particularly fluid medicaments, is an autoinjector, The nozzle extends along a longitudinal axis and has a proximal end near the dispensing location, a distal end opposite the proximal end, and a center a longitudinal housing having a hollow interior; a removable cap attachable to the proximal end of the housing; The syringe is mounted at a mounting position inside the housing and is aligned with the hollow syringe body containing the fluid product. a syringe assembly having a formed needle; a load or a trigger element that can be actuated by a trigger element to initiate dispensing of a fluid product; an activated drive mechanism; Tactile and / or audible and / or visual feedback to indicate the actual state of operation to the user. a feedback mechanism for providing a feedback signal; The needle extends from the proximal end of the housing with the sharp tip when the syringe assembly is in its loaded position. Protruding, The load or activated drive mechanism is operable to actuate a safety shield movable within the longitudinal housing. It is combined with The safety shield extends longitudinally from the housing to cover the needle with its sharp tip. The needle is biased to a proximal position protruding from the proximal end of the body, and the safety shield is attached to the injection needle with its sharp needle tip. a distal location where the injection needle is exposed for injection and movable against a biasing force; During use, the automatic drug delivery device is in the following operating states: The automated drug delivery device is fully assembled with removable end caps attached to the longitudinal housing The initial state, A removable end cap is removed from the housing and a safety shield covers the needle tip. , ready to use and The automated drug delivery device is pressed against the patient's skin, thereby causing the safety shield to extend along the longitudinal housing. a trigger state, which is pressed during injection to release the needle tip; a dispensing state in which the fluid product is dispensed into the patient's tissue; The fluid product has been completely dispensed and the automated drug delivery device has been removed from the patient's skin. and a use state in which the safety shield covers the needle tip.

[0136] The safety shield includes at least one distally extending longitudinal guided within the housing. The safety shield may possibly have two longitudinal arms. The safety shield is interlocked with the safety shield spring. The safety shield spring may act through the or each longitudinal arm. This allows for a relatively simple and compact actuation mechanism. The basic mechanical actuation and biasing functions are provided by the safety shield and syringe assembly. The axial direction of the slits can be concentrated at the distal end of the housing away from the slits.

[0137] The loaded or activated drive mechanism drives a plunger biased proximally by a drive spring. The plunger may act on a stopper, the stopper being sealable within the syringe body. The plunger may act on a fluid product contained within the syringe body. .

[0138] The proximal end of the drive spring may act on the distal end of the plunger. The end cap may be fixed to the distal end of the longitudinal housing. The fixed end cap may include a rod member for longitudinally guiding the drive spring. The fixed end cap may also be attached to the longitudinal housing by a snap-fit ​​engagement. .

[0139] The distal end of the drive spring is rotatably disposed within the fixed end cap along with the distal end of the plunger. The rotary click element and the fixed end cap may be received within the rotary click element. The cap may have a corresponding engaging sawtooth profile and may rotate in one rotational direction relative to the fixed end cap. Allows relative rotation of the rotary click elements and prevents relative rotation in the opposite rotation direction. The click element rotates relative to its axis depending on the rotational position of the rotary click element relative to the fixed end cap. Depending on the initially selected rotation position of the rotation click element, The intensity of the audible or tactile signal can be selected.

[0140] The autoinjector according to the present invention may be configured with different subassemblies, such as end caps, pre-filled syringes, and syringes. a syringe unit, and a proximal subassembly including a power unit subassembly. These three subassemblies may be used to assemble the device according to the invention. This may be provided as a separate pre-assembled module for the syringe unit. The syringe and power supply unit can be pre-assembled. The container is sealed and has a predetermined volume for drug delivery, and the desired drug is provided therein. can be used together with

[0141] The three subassemblies may be mounted within or on the syringe unit (if required). By inserting a pre-filled syringe into the syringe holder, a complete autoinjector can be created. The syringe unit can then be assembled to form a distal end of the syringe unit body. Insert the module into the power supply unit until it locks into place and cannot be separated. Due to its uniform construction, the device according to the invention can be easily assembled in an error-free manner. The term pre-filled syringe unit or pre-filled syringe is used herein to refer to a syringe with a needle. It should be understood that the term "syringe body" is used to refer to a syringe body that is attached to the syringe. It contains a variable volume chamber filled with a drug that can be expelled through a needle.

[0142] If necessary, the syringe may be provided with a syringe assembly or syringe subassembly. For this purpose, the syringe holder may be attached or coupled to the syringe holder within the housing or external to the housing.

[0143] The proximal syringe unit subassembly consists of an end cap body, a blade washer, and a proximal syringe. It may include a removable cap formed by an end cap cover. The proximal syringe unit subassembly consists of a safety shield, longitudinal housing and syringe holder. It may also include a

[0144] The syringe subassembly includes a rigid needle shield with an insert, a glass body with a fixed needle, It may contain a drug and a stopper.

[0145] The power unit subassembly includes the trigger element, trigger spring, shield retention indicator, and Includes plunger, drive spring, retainer, shield retention indicator inner element, and distal end cap. Good too.

[0146] The plunger may have a proximal end, the proximal end being adjustable to accommodate different syringe sizes, preferably A proper fit can be achieved by coupling with an adapter piece.

[0147] The device may have a label on the outside of the housing, which label indicates the status of the light and use indicator before use. It includes a black interior surface that inhibits the ability to see the edges. The device is opaque and therefore Prevents the ability to view the edge of the use indicator before use, or prevents the user from viewing the edge of the use indicator before use. The housing may have a label on the outside that is sufficiently opaque to limit its functionality.

[0148] The safety shield has a distal end with two diametrically opposed longitudinal arms. This arrangement of the body and longitudinal arms may comprise a unitarily formed hollow cylinder. Alternatively, it may be formed in separate pieces, i.e. the cylinder may be formed from a colored material. The device may include a separate cover that can

[0149] The ring-shaped body may have one or more protrusions near its distal end. The distal end of the body has a rounded circumferential ring with one or more opposing slots. The annular collar may include a longitudinal hollow extending distally from the annular collar; The two longitudinal arms are separated by a slot at the distal end of the collar. and a first transition portion between the collar and the first longitudinal arm portion. A first longitudinal arm portion and a second longitudinal arm portion each having a stepped course to form a shoulder. A second transition between each second longitudinal arm portion forms a second sloped shoulder. The outer circumferential surface of the stator has a sharp radial surface protruding radially outward and a sharp radial surface facing proximally and a sharp surface facing distally. The protrusion may have a beveled surface that is inclined and chamfered to the surface of the protrusion. The manual arm has a rectangular through hole near its distal end.

[0150] The outer circumferential surface of each second longitudinal arm may include an internal guide projection. The inner circumferential surface of the barrel may include guide ribs that project radially inward. The drive can guide the rigid needle shield during syringe assembly. The outer surface of the two longitudinal arms may have guide ribs, and the inner surface of the cylindrical body may have guide It may include a protrusion.

[0151] The cylinder is formed smooth and has a front ( As mentioned above, the cylinder may be a single piece with the longitudinal arms. It may be a one-piece construction or a multi-piece assembly.

[0152] The housing has the purpose of forming the body of the device. The housing is stable, rigid, transparent or opaque. If not entirely transparent, the housing may be used to reveal the liquid contents of the syringe and The device may be formed with a cutout or transparent window through which the drug can be viewed to allow the state of the device to be seen. Additionally or alternatively, the location of the stop may be such that the user The state of the device may be determined by the position of the stopper within the syringe body. The housing may be formed by a longitudinal tubular member. At its proximal end, the tubular member may have a length of approximately The proximal end may have a hollow cylindrical portion having a circular cross section and a front surface. The support member may be configured to swing out of the plane, for example, when a removable end cap is removed. Generally the same shape as the end cap cover to provide additional geometry with a stop function and an arcuate extension or lobe having a cross section.

[0153] At the proximal end of the housing, the cylindrical portion has opposing rib-like protrusions that protrude radially inward on its inner circumferential surface. The protrusion may be hidden or not visible from the outside, and the protrusion may be The housing is adapted to interact with a removable end cap. The body may be provided with two opposing longitudinal through holes that function as guide slots. Alternatively, these through holes can be replaced by guide channels. The panel opens to the inside of the housing but closes on the outer surface. Nearer the distal end, the housing may further comprise opposing through-holes, which may alternatively be internal. The housing may be provided with an internal recess, the internal recess being closed by an outer peripheral surface. The body may be provided with a pair of opposed transverse through-holes, which may alternatively be internal recesses. An internal recess can also be provided for mounting the power supply subassembly to the external The distal end may further comprise a distal front surface, the distal front surface being adapted to interface with the power unit. It has two opposing short notches to enhance rotational coupling.

[0154] The housing may have a ring or double ring structure therein, The structure is integrally connected to the tubular member in the region of the cylindrical portion by means of at least one rigid connecting arm. The connecting arm has two circumferentially running horizontal longitudinal connecting ribs and one horizontal connecting It can be formed by a stable U-shaped structure with ribs. The U-shaped cross-section should provide structural rigidity to the enclosure. This joint geometry also This is important for the flow of material when the component is being formed.

[0155] Furthermore, the ring structure or double ring structure has an outer ring running into a hollow inner ring with a conical transition. To the proximal end, reinforcing ribs may form a connection between the outer and inner rings. At the distal end, the conical transition may have one or more notches and / or The arrangement of the notches and axial projections is such that the pre-filled syringe is directly The syringe may be positioned in connection with a syringe holder.

[0156] The trigger element may be formed by a hollow body with a generally cylindrical shape. The element is surrounded by a chamfered rim and has two opposing radially extending lateral tabs. From the front of these transverse tabs, two rectangular projections extend longitudinally. The projections may extend radially outward to bias the safety shield. The tubular hollow body may include a chamfered protrusion extending distally. and a surrounding annular reinforcing rib connected to the proximal end and reinforced by a longitudinal rib in the middle thereof. Between the proximal end and the reinforcing rib, two opposing rectangular hollow box elements or other wall structures are provided. The recesses formed by the construction may be provided in the outer peripheral surface of the trigger element, and these box elements Alternatively, the recesses each provide a hollow space in which additional components, such as electronic sensors, can be placed. The trigger element may be provided to trigger the action of the triggering element during use of the drug delivery device. Acts as a temporary shutoff element for the wall hold indicator.

[0157] Further distally, the outer surface of the tubular hollow body has an L-shaped profile, e.g., to support a spring. The distal end of the tubular hollow body of the trigger element may be provided with additional annular and peripheral reinforcing ribs. The distal end may be formed by a hollow cylindrical portion having a front surface, the interior of which includes a trigger element. The element may be provided with a plurality of longitudinal guide ribs, preferably four, and two pairs of these guides The ribs are connected to each other by arch-shaped connecting ribs, and the arch-shaped connecting ribs are connected to the tubular hollow body. It extends circumferentially along the inner peripheral surface.

[0158] The end plate is an opaque, easily visible indicator color when the label is on the exterior surface of the transparent housing. It may also be a surface that has been

[0159] The shield spring biasing the shield retention indicator inner element distally The entire indicator can be concealed between the internal components of the device and the shield-retaining indicator. The location of the drug delivery device should be at a distal end that faces the user and is easily visible during use. can be done.

[0160] The distal end cap has the same cross-sectional profile as the distal end of the longitudinal housing, i.e., arcuate. The distal end cap body may have a rounded extension or lobe. The distal surface may be formed of a transparent material and closed by a distal surface. The rows may be rounded or chamfered. At its proximal end, a distal end cap is assembled. a skirt that is form-fittingly received within the distal end of the longitudinal housing in an erected state; The skirt may thus be inserted into the distal end cap via a reduced outer diameter and a stepped surface. It has a transition to the cap body.

[0161] In the area of ​​the stepped surface, the distal end cap corresponds to the notch described on the longitudinal housing The protrusion may be provided with a longitudinal protrusion that extends from the distal end cap to the notch. The cap can be positioned relative to the longitudinal housing. It may be slotted to provide longitudinal projections. The peripheral surface may be formed with respective chamfered snap-fit ​​projections. The protrusions snap into corresponding through holes provided in the longitudinal housing when the device is assembled. They are mated and engaged.

[0162] The snap-fit ​​engagement between the protrusion and the through-hole allows for easy separation once assembled It should be noted that the device according to the present invention is a disposable device and the distal end cap Once the cap is secured to the longitudinal housing, it is not removed from the housing again. Replacing or refilling the syringe after use, or once used, No other access to the components is provided or intended.

[0163] Looking inside the distal end cap, the end cap is integrally formed with the bottom surface of the distal end cap. Preferably, the distal end cap has an indicator indicating the state of use of the device. It is made of a transparent or opaque material that provides a 360° window to show the state of the Internally, the distal end cap is adapted to receive the distal body of a drive spring received within the distal end of the retainer. However, by choosing a neutral color for the holder, The placement of the catheter is not visible from the outside through the transparent distal end cap.

[0164] In the assembled or initial state of the device, the end caps are mounted on the longitudinal housing. The end cap is fitted with a corresponding receiving portion between two protrusions formed on the inside of the end cap body. The housing is circumferentially held within the cavity by engagement of respective internal protrusions formed on the proximal end of the housing. Moreover, the end caps are each formed on the inner ring portion of the end cap body. by respective engagement of internal protrusions formed within the proximal end of the housing, located behind the protrusions. The removable cap can be held longitudinally by the protrusions. The shaft is twisted away by the opposing protrusions that form the receiving space, while the shaft is pulled out by the opposing protrusions that form the receiving space. It can be held on the housing against a small twisting force below a force threshold.

[0165] The longitudinal housing has at least a transparent portion through which the actual state of operation is visible to the user. Alternatively, it may be made of a transparent or opaque material having a window.

[0166] The invention will now be further described, by way of example only, with reference to the following drawings. [Brief explanation of the drawings]

[0167] [Figure 1] Fig. 1 is a perspective view of the assembled drug delivery system. [Figure 2] Fig. 2 is an exploded view of the drug delivery device according to Fig. 1 showing its subassemblies, specifically the removable cap, the safety shield, the longitudinal housing and the syringe holder. Fig. 3 is an exploded view of the drug delivery device according to Fig. 1 showing its subassemblies, specifically the pre-filled syringe. [Figure 3]FIG. 4 is an exploded view of the drug delivery device of FIG. 1 showing its subassemblies, specifically the trigger element, trigger spring, shield retention indicator, plunger and spiral spring, retainer, shield retention indicator interior, and distal end cap. [Figure 4] 5 to 7 show different perspective views of the cap housing. [Figure 5] Figures 8 and 9 show different perspective views of the cap insert. Figures 10-13 show different perspective views of example needle shield grippers. [Figure 6] Fig. 14-18 show different views of the safety shield. [Figure 7] Figs. 19-22 show different views of the longitudinal housing. [Figure 8] Figures 23 and 24 show perspective views of the syringe holder. Figure 25 shows the assembled pre-filled syringe. [Figure 9] Fig. 26 and Fig. 27 show exploded perspective views of the rigid needle shield and its insert. Fig. 28 shows a perspective view of the syringe body. Fig. 29 shows a perspective view of the stopper. [Figure 10] 30 to 33 are different views of the trigger element. [Figure 11] Figs. 34 and 35 show different perspective views of the shield retention indicator. Figs. 36 and 37 are perspective views of the plunger. [Figure 12] Fig. 38 is a perspective view of the inside of the shield retention indicator. Figs. 39 to 41 are different views of the retainer. [Figure 13] 42-43 are different perspective views of the distal end cap. [Figure 14] Figures 44a to 44d show a side view (Fig. 44a) and different longitudinal cross-sections of the device according to the present invention in its initial state, where Fig. 44b is a longitudinal cross-section rotated by 90° relative to Fig. 44a, Fig. 44c is a longitudinal cross-section rotated by 180° relative to Fig. 44a, and Fig. 44d is a longitudinal cross-section rotated by 45° relative to Fig. 44a. [Figure 15] 45a to 45d are views according to FIGS. 44a to 44d with the removable cap partially twisted off the longitudinal housing. [Figure 16] 46a-46d show views according to FIGS. 44a-44d with the removable cap completely removed from the longitudinal housing and the device ready to dispense a fluid product. [Figure 17] 47a-47d are views according to FIGS. 44a-44d with the device already pressed against the patient's skin, with the safety shield partially pressed into the longitudinal housing. [Figure 18] Figs. 48a-48d are views according to Figs. 44a-44d showing the device pressurized against the patient's skin, the injection needle inserted into the patient's skin, the safety shield fully depressed into the longitudinal housing, and dispensing of the fluid product initiated. [Figure 19] Figures 49a-49d are views according to Figures 44a-44d showing a portion of the fluid product being dispensed. [Figure 20] 50a-50d are views according to FIGS. 44a-44d when the fluid product has been nearly completely dispensed and the indicator mechanism has been activated. [Figure 21] Figures 51a to 51d show the fluid indicator in accordance with Figures 44a to 44d when it has reached its final position. [Figure 22] 52a-52d are views according to FIGS. 44a-44d with the fluid product fully dispensed. [Figure 23] 53a-53d are views according to FIGS. 44a-44d of the device in the process of being removed from the injection site on the patient's skin, with the needle partially retracted from the patient's tissue and the safety shield partially released. [Figure 24] 54a-54d show views from FIGS. 44a-44d of the device in the process of being removed from the injection site on the patient's skin, with the needle completely retracted from the patient's tissue and the safety shield further released. [Figure 25] Figures 55a-55d show views according to Figures 44a-44d with the device completely removed from the injection site on the patient's skin, with the needle completely retracted from the patient's tissue and the safety shield completely released. [Figure 26] Figures 56a-56d show views according to Figures 44a-44d with the device completely removed from the injection site on the patient's skin, with the safety shield blocked against further axial recession. [Figure 27] 57-58 are different views of further examples of syringe holders. [Figure 28] 59-60 are different views of further examples of syringe holders. [Figure 29] Fig. 61 is a perspective view of a different drug delivery device in an assembled state. Fig. 62 is an exploded view of the drug delivery device according to Fig. 1 showing its subassemblies. [Figure 30] Fig. 63 is an exploded view showing the components of the syringe unit subassembly including the front cap according to Fig. 62. Fig. 64 is an exploded view showing the components of the syringe subassembly according to Fig. 62. Fig. 65 is an exploded view showing the components of the power supply unit subassembly according to Fig. 62. [Figure 31] Figs. 66a-66b are different perspective views of the distal end cap body. Fig. 67 is a perspective view of the distal end cap cover. Fig. 68 is a perspective view of the blade washer. [Figure 32] 69a and 69b are perspective views of the safety shield of the syringe unit subassembly. FIG. 70 is a perspective view of the safety shield indicator. [Figure 33] 71a and 71b are perspective views of a locking ring of the syringe unit subassembly, and FIG. 72a and 72b are perspective views of a syringe holder of the syringe unit subassembly. [Figure 34]Figures 73a and 73b are perspective views of the syringe unit sub-assembly housing, and Figure 73c is a side view of the syringe unit sub-assembly housing from the right, showing the internal structure. [Figure 35] Fig. 74 is a perspective side view of a rigid needle shield. Fig. 75 is a perspective side view of a needle-receiving insert for a rigid needle shield. Fig. 76 is a perspective view of a glass body containing a needle. Fig. 77 is a perspective view of a stopper. [Figure 36] 78a and 78b are different perspective views of the plunger rod of the power unit subassembly. FIG. 79a and 79b are perspective views of the shield retainer trigger of the power unit subassembly. [Figure 37] 80a and 80b are perspective views of a shield retention indicator for a power supply unit subassembly. FIG. 81a and 81b are perspective views of a retainer for a power supply unit subassembly. [Figure 38] 82a and 82b are perspective views of a rotary click element of the power unit subassembly, and FIGs. 83a and 83b are perspective views of a snap-fit ​​distal end cap of the power unit subassembly. [Figure 39] Figures 84a and 84b show the drug delivery device in a ready to use state, with Figure 84a showing a side view and Figure 84b showing a longitudinal cross section. [Figure 40] Figs. 85a and 85b are longitudinal cross-sectional views of the drug delivery device with the end caps just removed, Fig. 85a being a longitudinal cross-sectional view along plane A shown in Fig. 61, and Fig. 85b being a longitudinal cross-sectional view along plane B shown in Fig. 61. [Figure 41] 86a and 86b are longitudinal cross-sectional views according to FIGS. 85a and 85b of the drug delivery device when fully pressed against the patient's skin and drug delivery has just begun. [Figure 42] 87a and 87b are longitudinal cross-sectional views according to FIGS. 85a and 85b in intermediate states when the drug delivery device is delivering a drug to a patient. [Figure 43] Figs. 88a and 88b are longitudinal cross-sections according to Figs. 85a and 85b in an intermediate state when drug delivery is nearing the end. [Figure 44] 89a and 89b are longitudinal cross-sectional views according to FIGS. 85a and 85b of the drug delivery device when it has completely delivered the drug to the patient. [Figure 45] Fig. 90: Figs. 90a and 90c are longitudinal cross-sectional views according to Figs. 85a and 85b when the drug delivery device has been removed from the patient's skin and secured in a locked state after use. [Figure 46] As stated above. DETAILED DESCRIPTION OF THE INVENTION

[0168] In the following explanation, "Figure 1" refers to "Fig. 1" in [Brief Description of the Drawings] and [Drawings]. The same applies to "Figure 2" and subsequent figures. FIG. 1 shows a perspective side view of an automated mechanical drug delivery device 10 configured as an autoinjector according to the present invention. The device 10 includes a longitudinal body 12 extending along an axis X and a removable cap 50 at the proximal end of the device 10. The end of the device 10 against which the removable end cap 50 is positioned will be referred to as the proximal end in this description, and the proximal end will be in contact with the patient. The opposite end, to the right of FIG. 1, will be referred to as the distal end in this description.

[0169] FIG. 1 shows two different views (top view A) and longitudinal cross sections B, C and D. Directions A, B, C, and D are further shown diagrammatically. When describing the structure and operation of device 10 below, , it refers to these specific sight lines A and longitudinal cross sections B, C, D.

[0170] 2, 3, and 4 show subassemblies 100, 200, and 300 of device 10. In FIG. 3, the proximal subassembly 100 can be seen, including the end cap 50. , a subassembly including a pre-filled syringe unit 200 can be seen. In the figure, you can see the power supply unit subassembly 300. These three subassemblies The assemblies 100, 200 and 300 are separate pre-assembled parts when assembling the device 10 according to the invention. The syringe unit 200 and the power supply unit 201 are provided as assembled modules. The drug delivery kit 300 is pre-assembled and the required drug is provided therein in a sealed state. A corresponding pre-filled syringe 204 can be provided with a predetermined volume for do.

[0171] As can be seen below, the three subassemblies 100, 200 and 300 are pre-filled The syringe 200 is inserted into the receiving syringe unit 100, and then the power supply unit 30 0 into the open distal end of the body 12 of the syringe unit 100 from the right, i.e., distal, side. The power supply unit 300 is inserted into the device 1 until it locks into a predetermined, non-detachable position. This modular construction allows the device according to the invention to be assembled without errors. It can be easily assembled in this way.

[0172] An example of the device 10 will be described below with respect to its structure and function with reference to the drawings. The components of the device 10 as described below may be used independently of their respective configurations. Specifically, each of the three subassemblies 100, 20 0 and 300 and their components may be used separately and independently of other subassemblies. For example, the proximal subassembly 100 and its components may be 200 or power unit 300 may be used separately in other autoinjectors regardless of the specific design of the Therefore, the following description assumes that each and every component is described in the following context: This disclosure should be understood as limiting the scope of the invention to use only with additional components. Instead, this disclosure provides that any and all components disclosed therein are The characteristics of each subassembly can be independently determined, regardless of the interaction of its components. I want to be understood so that I can make a point.

[0173] Below, the components of the subassembly are described in detail.

[0174] FIG. 2 shows an exploded view of the proximal subassembly 100. The proximal subassembly 100 includes: , an end cap body 52, a blade washer 54, and a proximal end cap cover 56. Additionally, the proximal subassembly 100 includes a removable end cap 50 formed thereon. , a safety shield 102, a longitudinal housing 104, and a syringe holder 106. The components are described in detail below in connection with FIGS.

[0175] FIG. 3 shows an exploded view of the components of the subassemblies that form the prefilled syringe 200. The syringe subassembly 200 includes a rigid needle shield 202 with an insert 207, A glass body 204 with an integrally provided needle 206, a drug 208 shown as a liquid column, and and stopper 210. These components of pre-filled syringe 200 are shown in FIGS. This will be described in detail in relation to 9.

[0176] FIG. 4 shows an exploded view of the components of the subassemblies that form the power supply unit 300. The power supply unit subassembly 300 includes a trigger element 302, a trigger spring 304, a seal shield retention indicator 306, plunger 308, drive spring 310, retainer 312, shield retention The indicator includes an inner element 314 and a distal end cap 316. These components are described below. This will be described in detail in relation to Figures 30-43.

[0177] 5-7 show the removable end cap body 52 from different perspective views. The cylinder 58 provides a rocking edge when the cup is placed on a flat or slightly inclined surface. 1. The cylindrical body 58 is integrally formed with an arcuate extension 60 to form a non-circular perimeter. The outer periphery of the body 58 extends longitudinally between the proximal and distal ends of the body 58. The proximal portion of the body 58 has a number of integrally formed radial gripping recesses 62. The surface is formed by a smooth outer surface 64. This surface includes an arrow-shaped surface offset 66, The set 66 is used to twist the end cap 50 in or out of the longitudinal housing 12. Indicates the direction of movement.

[0178] Inside, the end cap body 52 defines an axially open receiving portion 70 having a smooth receiving surface. The receiving portion 70 includes a cylindrical surface 68 that defines a ring portion 72 formed integrally therewith. The cap portion 72 includes a substantially flat cylindrical front surface 74 facing distally. Between the second ring portion 72 and the inner peripheral surface 68, there is an open gap 75 and a connecting portion connecting both components. The ring portion 72 has a sintered structure 76 on its outer circumferential surface, which extends radially outward into the gap 74. On both sides of the protrusions 78, the outer peripheral surface of the ring portion 72 is inclined. Elevator formations 80 and 82 are provided at their distal-most positions near protrusion 78. , tapering distally to meet at apex 84.

[0179] As can be seen in FIG. 6 just below each protrusion 78, the outer circumferential surface of the ring portion 72 is divided into two surfaces. The protrusions 86 and 88 define a receiving space 90 therebetween. The receiving space 90 is formed on the inner peripheral surface as described in connection with FIGS. The longitudinal housing 104 has a proximal end for receiving and securing a protrusion 198 formed thereon. Provided.

[0180] On its radially inner surface, the ring body 72 has two opposing protrusions projecting radially inward. These two protrusions 92 are connected to the base 92 as described in connection with FIGS. and opposing radially outward projections 111 formed on the outer circumferential surface of the proximal end of the safety shield 102. 56 to secure the projection 156.

[0181] Focusing on FIG. 6, the end cap body 52 near its proximal end is shown as having oppositely disposed , two end cap members 52 secured to the inner circumferential surface of the end cap body 52 using connecting portions 96 and connecting ribs 98. It can be seen that it faces the circular arch 94.

[0182] 8 and 9 show the end cap cover 56. The end cap cover 56 is slightly A proximal end cap having the same basic surface as end cap body 52 with an angled projection 112. An annular cylindrical body 114 extends from the proximal face of the end cap portion 110. The annular cylindrical body 114 has a plurality of longitudinal ribs 118 on its outer circumferential surface 116. Longitudinal ribs 118 project above the distal end of the annular cylindrical body 114. These longitudinal ribs 11 8 at its free end, a snap-fit ​​projection projecting radially outward is provided as needed. 1, which engages within a corresponding (annular) recess in the end cap body 52. At this point, the annular cylinder 114 has a chamfered radially extending portion that runs into the inner cylinder 122. The inner cylinder 122 is also integrally formed with the distal surface of the end cap portion 110 and includes ribs 120. The cylindrical body 114, the protrusions of the ribs 118, the radially inner ribs 120, and the inner cylindrical body 122 The distal anterior surface of the arrangement formed by forms a conical contour.

[0183] 10-13 show two different examples of blade washer 54. 4 has a circular periphery 130 surrounding a ring-shaped body 132. , integrally formed with the ring-shaped body 132 and terminating in a circular radially inner gripping surface 136, 10 and 11. The example blade washer 54 is flat, whereas the example shown in FIGS. The blade washer 54 in accordance with the present invention is seen to have a frusto-conical shape. The lobes 84 provide an axial spring action, i.e., the lobes 84 are elastically deflectable in the axial direction. This can be done.

[0184] With the end cap 50 assembled, the blade washer 54 is positioned adjacent to the annular arch 94. The end cap cover 56 is pressurized into the proximal end of the end cap body 52. 13, so that the protruding end of the rib 118 contacts the ring-shaped body 13 of the blade washer 54. 2 and press the ring-shaped body 132 against the annular arch 94 (as an optional feature). The blade washer 54 is thereby firmly held and biased or alternatively The blade washer 54 is then attached to the proximal front surface of the annular arch 94 and the distal front surface of the end cap cover 56. The end cap is disposed with a slight axial distance between it and the conical structure formed on the end cap. The conical structure on the distal side of the cap cover 56 allows the lobes to be positioned axially proximally within this assembly. 1. Provide sufficient distance for the lobes 84 so that they can bend.

[0185] As an optional feature, one or two lobes 134 may engage a rigid needle shield 202. Then, the rigid needle shield 202 is rotated such that there is an asymmetric load-balancing force on the rigid needle shield 202. The other lobes 134 may have different lengths. This allows the rigid needle shield 20 2 is tilted or rotated so that it is deflected from its original position. Once the cap 50 is removed, it is time to re-capp it, i.e., reinsert the cap 50 onto the housing. This can be avoided.

[0186] 14-18 show different perspective views of the safety shield 102. The safety shield 102 is a ring having two diametrically opposed longitudinal arms 152, 154 at its proximal end; The body 150 and longitudinal arms 152, 154 include a hollow cylindrical body 150 having a cylindrical shape. The device can be made of one piece or a separate piece, i.e. the cylinder is made of a colored material. The housing may include a separate cover that may be formed from

[0187] The ring-shaped body 150 has two protrusions 156 near its distal end. The distal end of the body 150 has a rounded peripheral ring 160 with two opposing slots. A longitudinal hollow 164 extends distally from the annular collar 158. The two longitudinal axes extend in the longitudinal direction and are separated into two separate halves by a slot 162. Arms 152, 154 are integrally formed with the distal end of collar 158, and the collar 158 and the first longitudinal arm A first transition portion 166 between the first longitudinal arm portion 168 forms a first shoulder, and the first longitudinal arm portion 168 A second transition 170 between 168 and a second longitudinal arm portion 172 forms a second sloped shoulder. Each second longitudinal arm portion 172 has a stepped course so as to form a A sharp radial surface projects radially outward on the circumferential surface, facing proximally, and a sharp radial surface facing distally. The protrusion 174 has a beveled surface. The longitudinal arm 172 has a rectangular through-hole 176 near its distal end.

[0188] The inner circumferential surface at the distal end of each second longitudinal arm portion 172 defines an inner guide contour 178. Furthermore, the inner peripheral surface of the cylindrical body 150 is provided with four guide ribs 18 that protrude radially inward. These internal guide ribs 180 are provided to guide the rigid needle shield 202. It is served.

[0189] The cylinder 150 is secured to the front (nearby) of the device to prevent the cylinder 150 from damaging or abrading the patient's skin. As mentioned above, the cylindrical body 150 has a longitudinal length of 150 mm. The directional arms 152, 154 together can be a single piece structure or a multi-piece assembly. be.

[0190] 19-22 show different views of the housing 104. The housing 104 encloses the main body 12 of the device 10. The housing 104 is made of a stable, rigid transparent or opaque material. If not entirely transparent, the housing may be partially or completely transparent to allow the user to view the medication and device status. The housing 104 may be formed with a cutout or transparent window for viewing the drug. The distal end is formed by a tubular member 190. At its proximal end, the tubular member 190 has a circular cross section. A hollow cylindrical portion 192 and a front surface 194 are provided at a distance from the proximal end of the longitudinal member 1. The 90 features a removable cap to provide a non-swaying geometry on flat surfaces. It has a rounded hollow extension 196 that has the same shape and cross section as the extension 60 of the cap. At its proximal end, cylindrical portion 192 has two opposing rib-like projections that project radially inward. 198 on its inner peripheral surface, and the protrusion 198 is thereby hidden from the outside and can be removed. 1. The housing 1 is adapted to interact with a possible end cap 50. 04 has two opposing longitudinal through holes 220 which function as guide slots. Alternatively, these through holes 220 may open to the inside of the housing 104 but close on its outer periphery. The guide slot 220 is collinear with but distant from the guide channel 220. Nearer the distal end, the housing has two further opposing through holes 222. It may also be provided as an internal recess closed at its outer periphery. The housing 104 includes a pair of opposing transverse through-holes 224, which may alternatively be The distal end may also be provided as an internal recess closed by a peripheral surface. Included is a distal anterior surface 226 having two opposing short notches 228 .

[0191] Inside, the housing 104 includes a double ring structure 230, which includes: A pair of opposing rigid connecting arms 232 are used to connect the tubular member 190 in the region of the cylindrical portion 192. The connecting arm 232 is connected by two horizontal longitudinal connecting ribs 234 and The connection is formed by a stable U-shaped structure with one lateral connecting rib 236. The size of the ribs and U-shaped cross-sectional shape should provide structural rigidity to the housing 104. The joining geometry is also important to material flow as the component is formed.

[0192] Additionally, the double ring structure 230 includes a conical transition portion 240 and a hollow inner ring 242. To the proximal end, two reinforcing ribs 244 connect the outer ring 238 38 and the inner ring 242. Facing the distal end is a conical transition portion 240 has two opposing notches 246 and one rib-like axial protrusion 248. The arrangement of the notch 246 and the axial projection 248 is such that the syringe holder 106 is connected to the pre-filled syringe. For some variations, protrusions 248 are included. may not be included.

[0193] 23 and 24 show one example for syringe holder 106. Other examples of syringe holders are shown in FIGS. It is described in relation to 57-60.

[0194] Syringe holder 106 receives and holds a pre-filled syringe 204 within housing 104. The syringe holder 106 does not require any changes to the dimensions of other components of the device 10. and adapted to receive different types of syringes with different volumes of medication. Different size syringe holders 106 provide compatibility for different types / volumes of syringes You should.

[0195] The syringe holder 106 presents a longitudinal body 260. At its proximal end, the syringe holder 1 23. The U-shaped element 262 is formed with a rigid, inelastic U-shaped element 262. As can be seen, this rigid U-shaped element 262 opens in one radial direction. On the proximal anterior surface, the U-shaped element 262 is reinforced by parallel peripheral ribs 264, 266. , and two lateral ribs or protrusions 268. At its distal end, syringe holder 106 includes: A rigid, inelastic, similar U-shaped element 2 reinforced by two parallel peripheral ribs 272, 274. 70. Two peripheral ribs 272, 274 are provided at opposite positions facing radially outward. The two rigid U-shaped elements 262 and 272 are provided with notches 276, 278. The arms are connected by rigid connecting arms 280, 282. The connecting arms have radially inwardly projecting projections 284, 285 extending therefrom so that they face each other. 23. The inner surface 288 of the protrusions 284 and 286 is 23 and 24, so that the glass body of the syringe 200 can be placed and held therein. It's rounded as you can see.

[0196] Once placed within the longitudinal housing 104, the pre-filled syringe 200 is preferably rotated. The syringe holder 106 has two protrusions 268 that fit into the notches 2 in the double ring structure 230. 46, with the protrusion 248 positioned within the hollow space provided by the proximal U-shaped element 262. The syringe holder 106 is thereby positioned to engage with the longitudinal housing 1. 04 by a double ring structure 230, and the proper axial and rotational position about the longitudinal axis. It can be attached.

[0197] FIG. 25 shows the pre-filled syringe 200 in an assembled state, with the rigid needle shield 202 , is placed on the proximal front end of the syringe covering the syringe needle 206.

[0198] 26 and 27 show perspective views of the rigid needle shield 202 with the insert 207. The needle shield 202 comprises a tubular member 320 having an open distal end 322 and a closed proximal end 324. At its front, the rigid needle shield 202 is formed with lateral gripping ribs 326. Near its distal end, the rigid needle shield 202 has two opposing rectangular It has a through hole 328 of a shape.

[0199] The insert 207 is formed of a flexible, deformable material, and the insert 207 is firmly fitted therein. The needle can be pressed into the rigid needle shield 202 so that it is held securely in place. 07 has an annular collar 330 near its distal end, which is attached to the rigid needle shield 202 The rectangular through hole 328 engages with the

[0200] 28 shows syringe 204. Syringe 204 is a hollow cylindrical gun having an open distal end 334. The lath body 332 has an open distal end 334 formed by two flat opposing sides 338. At its proximal end, the cylindrical glass body 332 is surrounded by a circumferential annular collar 336 having a , formed with a rounded tapered portion 340, transitioning into a hollow conical glass portion 342, or terminates in a stepped needle hub 344 with a rounded proximal head 346. 46 securely holds the injection needle 206 with a sharpened needle tip 348 .

[0201] Figure 29 shows a stopper element 210 made from a flexible material, for example rubber. At this position, the stopper element 210 has a smooth cylindrical outer peripheral surface 350, which is The topper element 210 is adapted to be slidably engaged with the inner peripheral surface of the hollow cylindrical glass body 332 in a liquid-tight manner. , has a diameter that fits the inner diameter of the hollow cylindrical glass body 332 of the syringe 204. On the upper portion, the stopper element 210 has four circumferential rings forming three circumferential sealing ribs 352. The stopper element 210 has a closed proximal end 354 and an open distal end 356. It has a cup shape.

[0202] Turning now to the components of the power supply unit or drive assembly, FIGS. 30-33 show a The trigger element 302 is shown in different views. The trigger element is formed by a tubular hollow body 360. At its proximal end, the trigger element is surrounded by a chamfered rim 363 extending radially therefrom. The front surface 362 has two opposing lateral tabs 364, 366 extending from the front surface. From the front face 362 of the lateral tabs 364, 366, two rectangular projection plates 368, 370 extend longitudinally. The projection plates 368, 370 have chamfered projections extending radially outward. 372. The tubular hollow body 360 extends distally and is bounded by longitudinal ribs 376. The intermediate portion is provided with a surrounding annular reinforcing rib 374 connected to the reinforced proximal end. Between the upper proximal end 362 of the casing 360 and the reinforcing rib 374, two opposing rectangular hollow box elements 378 are provided. A recess formed by a wall structure or other wall structure is provided on the outer circumferential surface of the trigger element 302, which These box elements 378 or recesses each provide a hollow space within which additional components, e.g. For example, electronic sensors can be provided.

[0203] Further distally, the outer periphery of the tubular hollow body 360 is provided with an L-shaped loop for supporting the spring 304. The trigger element 302 has a hollow tubular portion 380 having a circumferential reinforcing rib 380 having a contoured tubular portion. The distal end of body 360 is formed by a hollow cylindrical portion 382 having a front surface 384. At the center, the trigger element 302 includes four longitudinal guide ribs 386, two pairs of which are The idle ribs 386 are connected to each other by arch-shaped connecting ribs 388. 8 extends in the circumferential direction along the inner peripheral surface of the tubular hollow body 360.

[0204] 34 and 35 show the shield retention indicator 306. The shield retention indicator 306 is The hollow cylindrical body 400 has an annular cylindrical component 402. 402 is extended by a rounded extension 404 that matches the geometry of the housing 104. The shield retention indicator 306 is located at the extension 19 of the hollow cylindrical body 190 of the longitudinal housing 190. 6 in a slidable but form-fitting manner. 6 has a smooth outer periphery 406. At its proximal end, the shield retention indicator 306 has four longitudinally flexible arms 408, each having a proximal free end 410. The free ends 410 of the arms 408 extend radially inward and terminate in short longitudinal chamfered ribs. The distal end of the shield retention indicator 306 includes a protrusion 412 reinforced by a protrusion 414. The end includes a circular opening 416 .

[0205] The outer surface 406 of the shield retention indicator 306 is a traffic light color, i.e., yellow, orange, or The color of the signal is preferably red or has a signal pattern that is clearly visible to the user. As the operation of the drug delivery device 10 is discussed in detail, the user of the device 10, i.e., a physician, The nurse or patient can see that the shield retention indicator 306 is visible from the outside through the longitudinal housing 104. When moved to a visibly apparent signal position, it can be easily recognized.

[0206] Figures 36 and 37 depict the plunger 308 in different perspective views. The plunger 308 is formed by a longitudinally extending pipe-shaped hollow element 420, and the hollow element 420 has a plunger head 422 at its proximal end. The plunger head 422 has a front face 424 and lateral slots 426. The front face 424 includes a small cylindrical through-hole 428. The front face with the lateral slots 426 and the cylindrical through-hole 428 can be coupled with additional plunger head elements, if necessary, for example, for a syringe with a larger inner diameter that interacts with a corresponding larger stopper 210. This additional enlarged plunger head can be used for a larger syringe, for example, having a drug volume of 2.25 ml. As shown in the example, in the case of a smaller syringe, for example, a syringe having a drug volume of 1 ml, the enlarged plunger head is removed, and the plunger 308 has just a straight cylindrical shape on its proximal end. A pair of opposing rectangular through-holes 430 are provided within the wall of the hollow element 420 in the middle part of the plunger 308. According to another example, the plunger may also have an additional pair of through-holes comparable to the through-holes 430 that can be adapted to different syringe sizes or drug filling volumes. At the distal end, the hollow element 420 has a circular opening 432 for receiving the drive spring 310 in the longitudinal direction. Figure 38 shows the internal elements 314 of the shield holder display. This element has a first hollow cylindrical portion 442 with a smaller diameter and an enlarged second hollow cylindrical portion 44 with a larger diameter. <00019 = 10>

[0207]

[0208]

[0209] 4, at its proximal end, is a stepped tubular body 440 having a shield retention indicator The vessel inner element 314 has two opposing flexible longitudinal arms 446 extending proximally. 4, with the first portion 448 running longitudinally and the second portion 450 extending slightly radially inward. The third portion 452 is inclined in the longitudinal direction but further radially inward than the first portion 448. At its proximal end, each arm 446 has an inclined, radially outwardly extending It has an angled retaining protrusion 454 .

[0209] The distal portion of the shield retention indicator inner element 314 is in contact with the distal end of the shield retention indicator 306. The second hollow cylindrical portion 444 has an end plate 456 having the same rounded elongated cross section. The outer diameter of the shield retainer indicator 306 fits within a circular opening 416 provided at the distal end of the shield retainer indicator 306. is adapted to receive

[0210] 39-41 depict the power supply unit 300 or drive assembly retainer 312. The tool 312 acts as a control member that includes multiple control functions for the power supply unit 300. The fixture 312 is formed from a hollow cylindrical body 470. On two opposite sides, the cylindrical body 470 has , each including a U-shaped notch 472 forming a longitudinally flexible arm 474. A flexible arm 474 is integrally connected at its distal end 476 to the hollow cylinder 470 . At its distal end, the flexible arm 474 includes a chamfered radially outward projection 478, a corresponding chamfered radially inward projection on the opposite side, i.e., its radially inner side; 480. Additionally, the cylindrical body 470 has a flexible arm formed by a notch 472. 474, in an area rotated by 90° with respect to the longitudinal notch 482. Longitudinal notch 482 has approximately the same longitudinal extension as U-shaped notch 472, but is slightly Extending further distally to the notches 482 near their proximal ends, the notches 482 extend approximately one-third of the longitudinal length of the notches 482. In one region of the cylinder 470, a lateral projection 484 is formed that laterally bridges the notch 482. These laterally bridging projections 484 are connected to additional projections 484 having the same circumferential shape. The proximal end is continued to be approached by 86.

[0211] At its proximal end, the cylindrical body 470 is integrally formed with the hollow cylindrical body 470. It has two flexible arms 490 that are inclined at an angle of approximately 45° to the proximal front surface. These flexible arms 490 are connected to a ring-shaped head 492. 2 is a bushing having a cylindrical portion 494 and two opposing proximal arcuate projections 496. The head 492 may be integrally formed with the flexible arm 490 or may be flexible. Formed as a separate piece rigidly connected to the flexible arm 490, for example, using an intermediate connecting ring. It is possible.

[0212] At its distal end, the cylindrical body 470 is formed with a circumferential groove 500. The distal end has a central opening 504. Near the distal end, the cylindrical body 470 has a distal end surface 502 with a distal end 504. An inner portion running axially or longitudinally between the end face 502 and the longitudinal portion having the circumferential groove 500. A guide rib 498 is provided.

[0213] 42 and 43 depict the distal end cap 316 of the device 10. The distal end cap 316 , a rounded hoop with the same cross-sectional profile as the distal end of the longitudinal housing 104, i.e., an extension. The distal end cap body 510 has a contoured distal end. The distal end cap body 510 is made of a transparent material. and is closed by a distal surface 512. Between the circumferential surface 514 and the distal surface 512 At its proximal end, the distal end cap 3 16 includes a plug portion 520, which is assembled into the distal end of the longitudinal housing 104. Therefore, the insert portion 520 has a reduced outer diameter and a stepped portion. It transitions into distal end cap body 510 via surface 522 .

[0214] In the region of the stepped surface 522, the distal end cap 316 is positioned relative to the longitudinal housing 104 as shown in FIG. 9-22. The interaction of the protrusion 524 and the notch 228 causes the distal end cap 316 to extend longitudinally. The plug portion 520 is positioned relative to the housing 104. Additionally, the plug portion 520 has two longitudinal The outer periphery of each of these longitudinal protrusions 526 is chamfered. These protrusions 528 are formed with snap-fit ​​projections 528 that secure the device together. When erected, they snap into engagement with corresponding through holes 224 provided in the longitudinal housing. It is provided to

[0215] The snap-fit ​​engagement between the protrusions 528 and the through-holes 224, once assembled, cannot be separated. It should be noted that the device according to the present invention is a disposable device and the distal end cap 3 16 is fixed to the longitudinal housing 104 so that it cannot be removed from the housing 104 again. The device allows for the syringe 200 to be replaced or refilled after use, or to be reused once used. This does not permit or intend any other access to the interior and components of the device 10. do not have.

[0216] Referring to the interior of the distal end cap 316, the end cap is formed by a bottom portion of the distal end cap 316. 43 includes a hollow cylindrical body 530 integrally formed with a surface 532.

[0217] The assembled state of the device 10 is described below with reference to Figures 44a to 44d. 44a shows a side view, and 44b to 44d show different longitudinal views of the device according to the invention in the initial state. 44b is a longitudinal cross-sectional view rotated by 90° relative to FIG. 44a. 44c is a longitudinal cross-sectional view rotated by 180° relative to FIG. 44a, and FIG. 44d is a longitudinal cross-sectional view rotated by 180° relative to FIG. 44a is a longitudinal section rotated by 45° relative to FIG. 44a. See arrows A, B, C, and D. The states shown are also the initial state of the device 10, i.e., the device is in a user-defined state. This is the state of the device in the method of delivery to the user.

[0218] In the assembled or initial state of the device 10, the end caps 50 are positioned above the longitudinal housing 104. The end cap 50 is screwed onto the end cap body 52 by two projections formed on the inside of the end cap body 52. Each of the recesses 86 and 88 is formed on the proximal end of the housing 104 within the corresponding receiving space 90. The end cap 50 is circumferentially held by the engagement of the internal projections 198. Each is located behind a protrusion 78 formed on the inner ring portion 72 of the end cap body 52. The longitudinal extension of the housing 104 is achieved by the engagement of respective internal protrusions 198 formed on the proximal end of the housing 104. The removable cap 50 is thereby held in the axial direction by the projections 78. The opposing projections 86 and 88 form a receiving space 90 and are twisted against the extraction force. It is held on the housing against a small twisting force below the peel force threshold.

[0219] Additionally, the safety shield 102 can be removed in the axial positions shown in FIGS. 44b-44d. The removable cap 50 keeps the assembly in the initial state shown in Figures 44a to 44d. Specifically, this is due to unintended distal movement, i.e., dropping the device 10 and causing the device 10 to This is intended to prevent the user from experiencing the impact of the safety shield 1 when it hits the ground. A protrusion 156 formed on the outer surface of the cylindrical body 150 at the proximal end of the cap 02 and a removable cap This is achieved by engagement between two protrusions 92 formed on the inner peripheral surface of the inner ring portion of the housing 52. Thereby, the protrusion 92 is attached to the removable cap attached to the housing 104. 1. The distal direction of the safety shield 102 relative to the housing 104 and thereby relative to the housing 104. It blocks any axial movement.

[0220] At the distal end, a distal end cap 316 is attached to the longitudinal housing 104 by a snap-fit ​​arrangement. and is fixedly and closely attached to the distal end cap 316, and is formed on the outer circumferential surface of the insert 520 of the distal end cap 316. The protrusion 526 engages within a through-hole 224 formed on the distal end of the housing 104 .

[0221] Additionally, in the assembled state, the syringe 204 is held within the syringe holder 106, The holder 106 is received within the ring structure 230 of the housing 104. As described above, the syringe holder The holder is positioned relative to the housing 104 using a ring structure 230 and lateral projections 26 8 engage within respective notches 246, and protrusions 248 engage with the syringe holder (see above). The syringe 204 projects into the hollow space provided by the U-shaped element 262. The U-shaped elements 262 and 272 are rigid and are axially compressed into the vessel holder 106. The syringe 204 is held in place by rotation within the syringe holder 106 so that it does not bend during assembly or operation. Please note that

[0222] Additionally, the syringe 204 is inserted into the syringe holder 106 using the head 494 of the retainer 312. and a conical stepped ring structure 22 of the housing 104 proximally through the syringe flange 336. 30, and the flexible arm 490 of the holder holds the syringe 204 in the syringe holder 1. 06 provides a spring force in the axial proximal direction to hold and thereby position the The rigid needle shield 202 is attached to the hollow cone-shaped needle by using the insert 207. The flexible insert 207 safely covers the needle 206, and the needle 206 and maintains the sterility of the drug contained within the syringe 204 and needle 206. As can be seen, the lateral gripping ribs 326 are provided, or alternatively, only the flexible outer surface. The outer surface of the tubular member 320 is formed with a blade washer 54 having a conical shape in this example. The flexible lobes 134 are engaged by the rigid The needle shield 202 may have different radial lengths to provide an unbalanced force on the needle shield 202. The blade washer 54 is attached to a removable end cap using a cap cover 56. The liquid is maintained in the cup 50.

[0223] Additionally, Figures 44b-44d show the ring-shaped cylindrical body 150 of the safety shield 102. The safety shield 102 is secured to the end cap 50 via longitudinal arms 152, 154. 308 is partially compressed distally into the housing 104 against the force of the shield spring 308. The trigger element 302 is located intermediate the longitudinal arms 152, 154 and the shield spring 304. As can be seen in Figure 44c, the trigger element 302 has a protruding plate 3 68, 370 to the distal ends of the arms 152, 154 of the safety shield 102. The protruding plates 368, 370 are attached to the distal ends of the arms 152, 154. 178. Additionally, the chamfered projections 372 are each engages within the through holes 176, thereby securing the safety shield 102 to the assembly. The arms 152, 154 are separated by axial force from the protruding plates 368, 370 of the trigger element 302. The chamber of the projection 372 and the guide contours 11 at the distal ends of the arms 152, 154 78 facilitates the assembly process.

[0224] The proximal end of the shield spring 304 engages the distal portion 382 of the trigger element 302, The peripheral rib 380 of the rib element 302 abuts against the peripheral rib 380, which has an L-shaped profile. , tightly holds the proximal end of the shield spring 304. The distal end of the shield spring 304 is the plate 456 of the shield retention indicator inner element 314 through the distal end of the shield retention indicator 306. Pressure is applied against the flanged proximal surface.

[0225] Furthermore, the shield retention indicator 306 having the cylindrical body 406 is The shield retainer indicator 306 receives and surrounds the shield spring 308 as well as the part 314. The four longitudinal arms 408 are provided between the lateral tabs 364, 366 and the box structure 378. Extending proximally through the provided gap, arms 408 each engage trigger element 302 The four longitudinal arms 408 project radially outward from the four protruding portions of the arms 408. 12 engages the outer periphery of the retainer 314 as seen in FIGS. 44b and 44c. , passes through the trigger element 302.

[0226] The holder 312 has an inner peripheral protrusion that fits into the outer peripheral groove 500 of the holder to hold the hollow circular The barrel 530 securely holds the distal end cap 316 in place. 312 is fixed within the device 10 against any axial movement and against tilt. .

[0227] The shield retention indicator 306 is compressed together with the shield retention indicator inner element 314. Despite the shield spring 304 and the resulting axial drive force, the arm 446 This is because the arms 446 pass through the longitudinal notches 482 in the retainer 312. and a lateral projection 484 of the retainer 312 that bridges the notch 382 of the retainer 312. This is achieved due to the fact that at the rear, they engage with the radially retaining protrusions 454. Moreover, in this state, plunger 3, which is radially disposed inside arm 446, The outer surface of the 08 is formed such that the arms 446 are bent radially inward to form a retaining mechanism on the lateral projections 484. Prevents escape from Noh.

[0228] Plunger 308 holds main spring 310 in compression, as described below. The proximal end of the compressed main spring 310 presses against the proximal end of the plunger 308. The proximal end 422 of the syringe 308 is positioned within the hollow glass body of the syringe 204 near the stopper element 210. 332. Additionally, the liquid contained in the syringe 204 The drug 208 can be seen as a post. The distal end of the main spring 310 extends from the plunger 308. 310 and is received within the hollow interior of retainer 310 against which main spring 310 rests its distal end. The plunger 308 is provided between the flexible arms 474. Due to engagement with the radially inward projection 480 that engages within the through hole 430, the main spring 31 The protrusion 480 is held in its axial position against a driving force of 0. It is possible to provide additional through holes 430 or slots into which the projections engage. The longitudinal position of the portion 480 is fixed within the device, so that the longitudinal position of the through-hole 430 is fixed within the device. As shown, the plunger head 422 is positioned in the slot. The stopper 210 is fairly close to the proximal end, but has a smaller fill volume. This may be further away from the plunger head 422. This can cause undesirable large impacts between the stopper 210 and the stopper 22. In such cases, the additional through-hole 430, which is longitudinally offset from the original through-hole 430, is A flexible arm may be included on the plunger 308 to offset the initial position of the plunger 308. 474 are in contact with their radially outward projections 478 and the inner circumferential surface of the trigger element 302. To better maintain its position, the flexible arm 474 is urged by the driving force of the compressed main spring 310. The plunger 308 is therefore unable to bend radially outward in response. The spools are held in place by the flexible arms and their radially inward projections 480.

[0229] From this fully assembled initial position, the device 10 according to this example of the invention can be used as follows: It is used.

[0230] Twist on removable end caps 50 Figs. 45a - 45d show views according to Figs. 44a - 44d in a state where a removable cap is partially twisted off from the longitudinal housing. The removable end cap 50 is slightly rotated relative to the housing 1 04. There is no axial movement. The relative rotation is carried out to such an extent that the engagement between the protrusion 198 formed inside the proximal end of the housing 104 and the protrusions 86 and 88 formed on the inner ring portion 7 2 of the end cap body 52 is released. To achieve this, a certain threshold value for the twisting force is provided to overcome the engagement between the protrusion 19 8 of the housing 104 and the protrusions 86, 88 of the removable end cap 50. Moreover, the engagement between the protrusion 156 on the proximal end 150 of the safety shield 102 and the protrusion 92 on the end cap body 52 is also released during this relative movement. In this state, there is no axial engagement between the removable end cap 50 and the housing 104.

[0231] [[ID=​​​​​​​​​​​​​​​​The user can then further rotate the end cap 50 relative to the housing 104 to separate the two components. are guided to separate from each other.

[0232] A proximal portion 150 of the safety shield 102 moves from the housing 104 and covers the needle. Relative movement between the door 102 and the housing 104 is achieved by a safety shield on each arm 152, 154. The formed protrusions 174 and the longitudinal through holes 22 acting as longitudinal guide channels. 0 is guided by the interaction between

[0233] During removal of the top end cap 50, the lobes 134 of the blade washer 54 The gripped rigid needle shield 202, together with its insert 207, is inserted into the hollow cone of the syringe 204. The syringe 204 is pulled out from the glass portion 344. The syringe 204 is supported in a rotating manner within the syringe holder. Due to the fact that unwanted coring can be avoided and the syringe has a rigid needle seal The needle 206 with its needle tip 348 is securely attached to the needle 206 and is not damaged by the removal of the needle 202. The entire shield 102 is exposed within a ring-shaped proximal body 150 .

[0234] Removable end cap 50 separate from housing 104 46a-46d show the removable cap completely removed from the longitudinal housing; 44a to 44d show the device in a state ready to dispense a fluid product. The removable end cap 50 can be seen to be completely separate from the housing 104 . The proximal portion 150 of the safety shield 102 protrudes completely from the housing 104, with its needle tip 348 The provided injection needle 206 is covered.

[0235] Initiating the injection by pressing the device against the patient's skin 47a-47d show the device 10 of FIG. 44a with the device 10 already pressed against the patient's skin. 44d, the safety shield is partially compressed within the longitudinal housing 104. There are.

[0236] As can be seen, the proximal anterior surface of the proximal portion 150 of the safety shield 102 is in contact with the patient's skin S. The device 10 is in contact with the patient's skin S by holding the housing 104. The safety shield 102 is thereby pressurized into the housing 104, There is relative movement between these two components. Again, the arms 15 of the safety shield 102 2, 154 and engages into longitudinal hole 220 in housing 104. , guides the safety shield 102 along its relative linear motion with respect to the housing 104 .

[0237] Due to the movement of the safety shield 102 into the housing 104, the arms 152, 154 The trigger element 302 is forced distally, causing the trigger element 302 to release the shield protection. It moves under the arm 408 of the indicator 306 with its chamfered proximal rim 363. As a result, arm 408 bends as shown in Figure 47d.

[0238] Initiating drug dispensing by further pressing the device against the patient's skin As the device 10 is further pressed against the patient's skin S, the safety shield 102 closes the housing 104 As the needle 206 moves further distally into the The situation is reached as shown in Figures 48a to 48d. 44a-44d show the needle in a state of pressure against the skin, with the needle inserted into the patient's skin. pierced, the safety shield 102 is pushed completely down into the longitudinal housing 104, The dispensing of the body product begins.

[0239] Due to the relative movement between the safety shield 102 and the housing 104, the needle 206 is exposed and can be easily inserted into the patient's mouth. The safety shield 102 is compressed by the spring 304 to project into the skin S of the patient. The handle 102 is attached to the trigger element 302 with its front surface 362 by the flexible arm 4 of the holder 314. 74. The main spring 310 is pressurized into the housing 104 to move it past the protrusion 478 of the main spring 310. In response to the action, plunger 308 is axially compressed by the surrounding surface of throughbore 430 . The surrounding of the through hole 430 engages with the chamfer of the radially inward projection 480 of the flexible arm 474. The surface acts as a force to the main spring 310, forcing the flexible arms 474 of the retainer 312 radially outward. This is because the retainer presses against the outer projection of the flexible arm 474, as shown in FIG. This is possible because the flexible arm 474 is moved beyond the The plunger 308 is released to move the shaft in the forward direction.

[0240] Dispensing drugs into a patient's tissue 49a-49d show the fluid product shown in FIGS. 44a-44d with a portion of the product already dispensed. The plunger 308 is held in an axial position by the flexible arm 374 of the holder 312. No longer held, plunger 308 moves proximally, engaging stopper element 210. 200 and biases the stop element 210 proximally under the action of the main spring 310. The drug is injected into the patient's tissue through the injection needle 206 as indicated by the three thin arrows. The syringe 204 is then forced out of the glass body 332 .

[0241] This process continues with complete dispensing of the drug into the patient's tissue.

[0242] Reaching the end of the dispensing process and starting the indicator mechanism 50a-50d show the results of the process of FIGS. 44a-44d with the fluid product nearly completely dispensed. At this stage of the device, the indicator mechanism is initiated. As can be seen, the stop element The plunger 210 nearly reaches the proximal bottom surface of the cylindrical glass body 332 of the syringe 204. 308 moves further proximally in response to the expansion of main spring 310. Thus, the distal end of plunger 308 is secured to the flexible longitudinal end of shield retention indicator inner element 314. The plunger 308 then moves proximally beyond the end of the arm 446. no longer blocks the radially inward bending of the longitudinal arms 446.

[0243] A spring 304 is supported against the safety shield 102 via the trigger element 302 and is configured to move distally. Due to the compressed state of the spring 304, the distal end of the spring 304 tends to expand in the Apply pressure to the distal end of the shield retention indicator 306 to seal the shield retention indicator 306. The retained indicator inner element 314 pushes the combined arrangement together distally. Thus, the longitudinal flexible arm 446 is radially supported by the inclined retaining projection 454. It bends inward and passes through a lateral projection 484 that bridges the notch 482. The combination of the shield retention indicator 306 with the shield retention indicator inner element 314 is , freely moving distally.

[0244] As outlined above, the outer surface 406 of the shield retention indicator 306 may be a signal color or pattern. The outer peripheral surface 406 is connected to a transparent area of ​​the distal end cap 316 which is transparent all around. Upon entering, the user can immediately see the signal color or pattern.

[0245] The indicator reaches its final position 51a-51d show the shield retention indicator 306 of FIG. 4 in its final position. 50a to 50d are shown in the diagrams of FIGS. As can be seen, the shield retention indicator 306 is held in place by the action of the expanding spring 304. The entire assembly is pressurized into the distal end cap 316 upon receipt of the pressure.

[0246] Upon reaching the distal inner bottom surface of end cap 316, shield retention indicator inner element 314 impacts its end plate 456 and the inner bottom surface 532 of the distal end cap 316, thereby possibly This impact contact is reached under the action of a release spring 304 which generates an audible and / or tactile signal. The touch acts in the axial direction and is clearly palpable by the user. The sound generated is sufficient to be heard by the user under normal circumstances as a clearly audible click signal. This allows the user to quickly turn off the device immediately after reaching a point near the end of the fluid dispensing process. Get feedback from 10.

[0247] Shield retention indicator 306 is attached to shield retention indicator inner element 314 in a distal direction. The spring force of the spring 304 when releasing the coupling is strong enough to hold the coupling for a very short period of time, e.g., several minutes. It is noted that this trigger function may be initiated within milliseconds or tenths of a second.

[0248] Reaching the end of the dispensing process As mentioned above, the signaling mechanism starts just before the end of the dispense process is reached. When the signaling mechanism is initiated, the stopper element 210 is still attached to the syringe, as shown in FIG. 51a. This is due to the fact that the end position within the glass body 332 has not been reached.

[0249] 52a-52d show the views according to FIGS. 44a-44d with the fluid product fully dispensed. In this state, the stopper element 210 is positioned at the proximal end of the glass body 332 of the syringe 204. As a result, the complete dose of the drug is expelled from the syringe 204.

[0250] Initiating removal of device 10 from the patient's skin Once the dose is completely dispensed into the patient's tissue, the device 10 can be removed from the injection site. Figures 53a to 53d show the process of the device being removed from the injection site on the patient's skin. 44a-44d show a state in which the needle is partially retracted from the patient's tissue and the safety system is in place. Some restrictions have been lifted.

[0251] A portion of the housing 104 of the device 10 is seen being pulled out of the patient's skin, revealing the safety seal. The proximal front portion 150 of the rod 102 is still in contact with the patient's skin S. The compressed spring 304 moves the safety shield 102 longitudinally via the trigger element 302. The spring 304 acts on the arms 152 and 154, compressing the housing 1. 04, thereby pushing the safety shield 102 out of the syringe needle 20. 6 is retracted from the patient's skin S together with the housing 104, and is permanently covered during this retraction process. .

[0252] This can be seen in Figures 53a-53d. While the housing 104 is being retracted, its proximal end 150 The provided safety shield 102 remains in contact with the patient's skin S so that the needle is permanently covered. be.

[0253] Complete removal of device 10 from the patient's skin Finally, the housing 104 has by now been lifted from the patient's skin, so that the needle is in the safety shield. The proximal end 150 of the syringe 102 is completely covered by the sharp tip of the syringe needle. In other words, due to the action of the expanding spring 304, the safety system As the safety shield 102 is thus pushed out of the housing 104, the safety shield 102 It completely covers and protrudes above the needle tip 348 .

[0254] 54a-54d show intermediate steps in the process of the device being removed from the injection site on the patient's skin. 44a-44d show the needle fully retracted from the patient's tissue and the safety seal in place. The lock is further released.

[0255] Figures 55a-55d show the device on the patient's skin after it has been completely removed from the injection site. 44a-44d show the needle fully retracted from the patient's tissue and the safety shield fully in place. The axial end position of the safety shield 102, i.e., the action of the expanding spring 304, Its final position after being pushed out of the housing 104 is against the proximal end of the longitudinal through-hole 220. In this position, the spring 304 Although the safety shield 102 is still spring-loaded in the proximal direction by The proximal portion 150 of the safety shield 102 cannot move further proximally. 50 reaches a position where it protrudes from the housing 104 at its maximum. At this position, the sharp needle tip 348 is well positioned behind the proximal end 150 and safely enclosed therein.

[0256] Blocking Distal Movement of Safety Shield 102 After Use As described above, when the safety shield 102 is pushed out of the housing 104, the shield retention indicator 3 The combined arrangement formed by the shield retainer indicator inner element 314 and the shield retainer indicator inner element 314 The distal end is held in place within distal cap 316. However, as noted above, the spring 304 Due to the action, the trigger element 302 is moved in the proximal direction. The shield holding indicator 306 is pushed out of engagement with the arm 408 by the spring force of the spring 304. In other words, the arm 408 is again bent as seen in Figures 52a-52d. , two of which extend beyond the proximal chamfered rim 363 of the trigger element 302 .

[0257] During further proximal movement of trigger element 302, the radially inward projection of arm 408 412 until the protrusion 412 reaches the chamfered annular reinforcing rib 374 of the trigger element 302. , sliding along the outer periphery of trigger element 302. This can be seen in Figures 53a-53d. In response to further movement, arm 408 rotates to form a chamfered annular It again bends radially outward to clear the reinforcing rib 374 .

[0258] Passing through the chamfered annular reinforcing rib 374, the arm 408 is forced to a radius due to its inherent resilience. snap-fit ​​inwardly in the direction of the arrows and grip distally just behind the chamfered annular reinforcing rib 374 The distal surface of the chamfered annular reinforcing rib 374 is beveled so that the rib 374 has a concave conical profile. In addition, the protrusions 412 are shaped within this concave conical contour. This engagement is achieved by the arms 408 being inclined in a mating manner. Instead, the engagement occurs when the arms 408 are pressed against the recesses of the annular reinforcing rib 374. The shield retention indicator 306 thereby engages the conical distal surface of the trigger element 304. 302. As a result, any distal movement of the safety shield 102 is blocked. This is the safety system that has reached the state shown in Figures 55a to 55d. This means that the box 102 cannot be pressed into the longitudinal housing 104.

[0259] This is shown in Figures 44a-44b with the device completely removed from the injection site on the patient's skin. 56a-56d, which show the diagrams by d, the safety shield is subject to further axial collapse. In this state, once a force is applied to the proximal portion 150 of the safety shield 102, When the shield is in the closed position, the arms 408 of the shield retention indicator 306 block any distal movement. In this state, the shield retention indicator 306 is configured to use the shield retention indicator inner element 314 to Physically, the end plate 456 is supported against the bottom surface 532 of the distal end cap 316. As such, the latter is irremovably connected to the housing 104 .

[0260] As a result, the safety shield 102 with its proximal portion 150 is needle-resistant against any misuse. 206 safely and irreversibly covered.

[0261] advantage The device 10 according to the above example of the invention has, in particular, the following advantageous features: The device 10 includes three different pre-assembled sub-assembly syringe units 100, The syringe 200 can be easily assembled from a pre-filled syringe and a power supply unit 300. The pre-filled syringe 200 is a different syringe that requires a suitable syringe holder 106. It can be provided in a variety of shapes and sizes. The distal end cap 50 can be easily removed from the housing 104 by twisting it off. The support is provided by the action of a spring 304. During use, the device provides audible and / or tactile and / or visual signals of different states of operation. Give. Unless a drug is delivered, the user will not see this state as the transparent housing 104 or any device provided therein. It can be seen through the window. The device does not show any visual indicators until drug delivery is complete. Drug delivery is initiated by pressing the device against the patient's skin. Once initiated, drug delivery cannot be stopped. This is because the device is used multiple times. Prevent this. The device is easily intuitive because it does not have a separate trigger element, such as a button. Activation occurs when the device, with its safety shield 102, is pressed against the patient's skin. It is brought about only by pressure. The device has no rotating parts and no corresponding complex rotational movements, which simplifies the manufacturing of the device. It is simple, easy to use, and reliable.

[0262] In short, the device facilitates the assembly of a structure that can accommodate different types of syringes. The device is easy and intuitive to use in a safe manner. A back signal is provided to the user.

[0263] Syringe holder alternatives 57 and 58 show an alternative embodiment for syringe holder 600. Syringe holder 600 is , formed by two longitudinal shells 602, 604, which are The two shells 602, 604 are formed with longitudinal cuts 606, 608 therebetween. It is connected by two flexible V-shaped arms 610, 612 on the distal and proximal parts, The arms 610, 612 provide circumferential flexibility to the syringe holder 600, thereby allowing the syringe This allows the shells 602, 604 to resiliently move apart when the syringe is introduced. The holder 600 has a syringe holder near its distal end 614 and a syringe holder near its proximal end 616. It further includes radially outwardly projecting structures 618, 620 for securing it within the syringe housing.

[0264] In FIG. 58, once distally inserted and received within syringe holder 600: Radial indentations formed within both shells 602, 604 provide axial support for the syringe. The protrusion 622 can be seen.

[0265] 59 and 60 show a further alternative syringe holder 640. This syringe holder: It has a hollow cylindrical receiving tube 642 with a distal end 644 and a proximal end 646. Similar to the example described above, this syringe holder 640 may be configured to hold the syringe holder within the housing of the autoinjector. It also includes radially outwardly protruding structures 648, 650 for supporting the bearing.

[0266] Near its proximal end, the syringe holder includes two double z-sections 652, 654. 652, 654 are angled flexible arms 656 interconnected by a perimeter rib 660. , 658. On its inner circumferential surface, the syringe holder includes a radially inward projection 662, Portion 662, once inserted distally and received therein, allows the syringe to be axially Circumferentially formed in both flexible double z-sections 652, 654 for support. Within syringe holder 640, the syringe is fitted with a small amount of radial play within hollow cylindrical receiving tube 642. 644. To grasp the proximal front end of the syringe body, Due to the resilient flexibility of the two double z-sections 652, 654, the arms 656, 658 are The knob 660 bends slightly to move radially outward.

[0267] Both alternatives of the syringe holder according to Figures 57-60 are slightly flexible in the radial or circumferential direction. The syringe has a circumferentially closed structure characterized by providing a The syringe is provided radially outward, allowing the syringe to be easily assembled with the syringe holder. The syringe is simply held in place by a flexible element that is attached to the syringe. This allows for tolerance variations in the glass syringe to be accommodated within the radius Both outward and axial compensation is possible. The dam has a robust structure with a shell or cylindrical receiving tube.

[0268] FIG. 61 illustrates an automated mechanical drug delivery device 1010 configured as an autoinjector in accordance with the present invention. The device 1010 includes a longitudinal body 1 extending along an axis X at the proximal end of the device. 012 and removable end cap 1050. The end of device 1010 where tip 1050 is located is referred to herein as the proximal end, The opposite end on the right side of Figure 61 is referred to herein as the distal end.

[0269] A portion of the body 1012 is covered by a label 1014, which is attached to the device 101. 61. The ready to use stent shown in FIG. In this state, the tamper label 1012 attached to the distal portion of the body 1012 and the end cap 1050 is 016 can be seen. When end cap 1050 is removed, tamper label 1 016 is torn, thereby indicating that end cap 1050 has been removed.

[0270] FIG. 61 further shows schematically two different planes A and B, which represent planes of longitudinal section. In the following, when describing the structure and operation of device 1010, planes A and B are referred to as longitudinal cross sections. These specific planes are referred to as planes.

[0271] Figure 62 shows three subassemblies of the device 1010. On the left: end cap 105 11. The syringe unit subassembly 1100 can be seen, which includes the syringe unit Next to the subassembly 1100, a subassembly including a pre-filled syringe unit 1200 is On the right, you can see the power supply subassembly 1300. These three subassemblies 1100, 1200, and 1300 are the components of the present invention. When assembled, the device 1010 is provided as separate pre-assembled modules. This allows the syringe unit 1100 and the power supply unit 1300 to be pre-assembled. A corresponding drug delivery system having a predetermined volume for drug delivery, the required drug being provided sealed in the corresponding drug delivery system. A pre-filled syringe 1200 can be provided.

[0272] As can be seen below, three subassemblies 1100, 1200 and 1300 are The filled syringe 1200 is inserted into the receiving syringe unit 1100 and then connected to the power supply unit. Insert the knit 1300 from the right side into the open distal end of the body 1012 of the syringe unit 1100. Assemble the power supply unit 1300 into the device by inserting it until it locks into place. This modular construction allows the device according to the invention to be installed in an error-free manner. It can be easily assembled.

[0273] An example of the device 1010 will be described below in terms of its structure and function in conjunction with the drawings. The components of the device 1010 as described below may be used independently of their respective structures. Specifically, three subassemblies 1100, 1200, and 1200 can be used. 00 and 1300 and their components shall be treated separately and in accordance with other subassemblies. For example, the proximal subassembly 1100 and its components The components may be separately configured in separate autoinjectors, such as the injector unit 1200 or the power supply unit 1300. The following description can be used regardless of the particular design of the device. The composition element is limited to the way in which it can only be used with further components as described in the context below. Instead, the present disclosure is not to be construed as a disclosure of any and all of the methods disclosed therein. Each component is independent of the interaction of the components of each subassembly. It should be understood that each feature may be claimed separately.

[0274] Below, the components of the subassembly are described in detail.

[0275] FIG. 3 shows an exploded view of the syringe unit subassembly 1100. The blade subassembly 1100 includes an end cap body 1052, a blade washer 1054, and and a proximal end cap cover 1056. Above, the syringe unit subassembly 1100 includes a safety shield indicator 1102, a safety shield The syringe holder 111 includes a locking ring 1104, a locking ring 1106, a longitudinal housing 1108, and a syringe holder 111. 0. These components are described in detail below in connection with Figures 66a-73.

[0276] FIG. 64 is an exploded view of the components of the subassemblies that form the pre-filled syringe 1200. This syringe subassembly includes a rigid needle shield 1202, an integrally provided needle The glass body 1204 with 1206, the medication 1208 shown as a liquid column, and the stopper 12 10. These components of the pre-filled syringe 1200 are shown in conjunction with FIGS. 74-77. The details are described in detail below.

[0277] FIG. 65 shows an exploded view of the components of the subassemblies that form the power supply unit 1300. The power supply unit subassembly 1300 includes a plunger 1302, a drive spring 130 4, including a shield retention trigger element 1306 and a shield spring 1308. The knit subassembly 1300 includes a shield retention indicator 1310, a retainer 1312, a The distal end cap 1316 includes a click element 1314 and a distal end cap 1316. These components are shown in FIG. 8a-83b are described in more detail below.

[0278] 66a and 66b show the end cap body 1052 from different perspectives. A number of integrally formed radial gripping portions extend longitudinally from the proximal end of 52 to its intermediate portion. The cylindrical body can be seen to have ridges 1058. The distal part has a smooth outer surface 1060. This surface includes an arrow-shaped through hole 1059, 1059 indicates the direction of movement for twisting the end cap 1050 off of the body 1012. Additionally, two opposing retaining ribs 1061 can be seen in Figures 66a and 66b. The retaining ribs 1061 are each provided on the inner peripheral surface of the end cap body 1052 and are 1059. These retaining ribs 1061 are discussed below in connection with FIG. 10. When engaged in U-shaped projection 1178, end cap body 1052 is secured to housing 1. 108 is provided for holding on.

[0279] Inside, the end cap body 1052 has an axially open receiving portion with a smooth receiving surface. 1062. A rib 1064 extending radially inward is formed adjacent to the receiving portion 1062. Following the portion containing the ribs 1064, the end cap body 1052 has an end The cap body 1052 includes a stepped surface 1066 that abruptly increases the inner diameter of the cap body 1052. The stepped surface 1066 Stepped surface 1066 twists end cap 1050 in or out of body 1012 1108. The drive lug 1108 acts as a drive curve when engaged with a corresponding drive lug on the housing 1108. At the distal end, the interior of the end cap body 1052 is axially aligned with the housing 110. Further radially inwardly extending ribs 1 serve as contact means for interacting with the outer peripheral surface of 8. Includes 068.

[0280] Figure 67 shows the cap cover 1056. The cap cover 1056 is a pressure fitting engagement. The outer peripheral surface 107 is adapted to lead into the open receptacle 1062 of the end cap body 1052. The cap cover 1056 includes a cylinder with a closed proximal end wall 1072. Extending axially distally from the end wall 1072, the cap cover 1056 has a radius An inner cylindrical ring 1074 is provided with directional inner ribs 1076 formed thereon. The distal end face 1078 of 76 is angled slightly inward to form a circumferential bevel.

[0281] Figure 68 shows the blade washer 1054. The blade washer 1054 is a ring-shaped The blade washer 1054 has a circular periphery 1080 surrounding a body 1082. Four integrally formed profile 1082 terminating in a circular radially inner gripping surface 1086 The blade washer 1054 includes a radially inwardly extending lobe 1084. It can be seen that the axial spring 1084 has a truncated conical shape. , i.e., the lobes 1084 are capable of elastically deflecting in the axial direction.

[0282] Generally, the outer geometry 1080 of the blade washer 1054 is circular or any suitable assembly. It may be any other geometry that suits the load or packaging space. 1084 may be present and the blade geometry may be adjusted to achieve a certain insertion force. The needle shield may be of any type and may be configured to provide a rigid needle shield when the end cap is removed from the housing. Generally, the blade washer 1054 may be any feature that retains force from the blade. In other examples, the blade washer may have a planar or flat shape. It may also have a pre-formed shape, for example the blade washer may be formed into a cone or wave shape. In one example, ribs can be placed around the outer rim of the blade washer to strengthen the ribs. This may prevent rotation of the blade washer during cap removal. It may be possible to do this by simply rotating the cap and pulling the blade washer longitudinally. In this case, it is possible to remove the unfavorable conditions known as coring. This occurs when the rubber of the rigid needle shield rotates around the needle. The rubber plug then penetrates the inside of the needle. This is undesirable as it may cause the device to stop functioning properly. It can be disruptive.

[0283] With the end cap 1050 assembled, the blade washer 1054 is secured to the rib 1064 and presses the cap cover 1056 into the receiving portion 1062. The blade washer 1054 is thereby clamped against the rib 1064. The needle shield 1202 is held in place by a spring or by axial elastic deflection to secure the needle shield 1202, described below. To be able to grip, the cylindrical radial outer front surface 1086 of the cap cover 1056 and the rib 1 The inner ring 1074 is arranged with a slight axial gap between it and the inner ring 1074. The lobe 1084 is positioned far enough away to allow for axial bending proximally. can be.

[0284] 69a and 69b show different perspective views of the safety shield 1104. 104 is a ring-shaped device with two diametrically opposed longitudinal arms 1114, 1116. The ring-shaped body includes a ring-shaped body 1112. The ring-shaped body extends from a cylindrical portion 1118 to an axial opening 1119. 122 with a stepped protrusion to reduce the diameter to a rounded front end 1120 The inner diameter of the axial opening is adjusted to fit the rigid needle shield 1202. The outer diameter of the rigid needle shield 1202 so that the shooter can move through it without friction The front end 1120 of the safety shield 1104 is rounded to avoid sharp edges. Furthermore, the safety shield 1010 of the device 1010 according to the present invention is 104 forms a trigger element when pressed against the patient's skin with the required actuation force. The front end 1120 of the lever is smooth so that the front end 1120 does not damage or abrade the patient's skin. is formed.

[0285] The two longitudinal arms 1114 and 1116 each have a slightly rounded shape. and includes a longitudinally slotted through-hole 1124 adjacent to the cylindrical portion 1118. The through holes 1124 are provided in positions opposite to each other. serves as a guide means for guiding the needle shield 1104 for longitudinal movement within the device 1010. It acts as a

[0286] The ring-shaped body 1112 of the needle shield 1104 is formed with four radially inwardly extending ribs 1112. These internal ribs 1126 support the rigid needle shield 1202 against deflection. 1200 in its assembled state. Additionally, the ring-shaped body 1112 of the needle shield 1104 , a proximal wall 1129 and a distal wall 113 each running substantially perpendicular to the major axis X 11. It includes two opposing through holes 1128 with .0.

[0287] FIG. 70 shows the safety shield indicator 1102. The safety shield indicator 1102 The proximal ring-shaped body 1112 of the needle shield 1104 is engaged by a snap-fit ​​and / or mating engagement. Alternatively, the safety shield indicator may simply be formed as a thin-walled element that can be coupled to the needle. This may be provided as a colored coating on the front of the shield 1104 or as a needle shield 1106. 104. For this purpose, the safety shield indicator 1 102 is an inner surface ring corresponding to the outer surface contour of the ring-shaped body 1112 of the needle shield 1104 The safety shield indicator 1102 has a signal color, i.e., yellow, that is clearly visible to the user. The drug delivery device according to the present invention has an outer peripheral surface having a color, such as orange or red. As will be discussed in detail in connection with the operation of device 1010, a user of device 1010, i.e. The doctor or patient can see the needle 1206 when the safety shield indicator 1102 protrudes from the housing 1108. It's easy to know when to cover.

[0288] 71a and 71b show the structure of the lock ring 1106. The lock ring 1106 is When the device 1010 is activated to deliver the drug to the patient, the safety shield 1104 closes the housing. fully pressurized into the body 1108 to engage the safety shield 1104 during use. After engaging the safety shield 1104, the locking ring 1106 forms a safety seal. The device is permanently attached to the safety seal 1104 after the device has been used and the drug has been fully delivered. This prevents the ring 1104 from being pushed back into the housing 1108 a second time.

[0289] The locking ring 1106 includes a closing ring 1132 with two opposing recesses 1134. Radially inward of these recesses 1134, the locking ring 1106 is Two flexible arms formed on opposing lobes 1138 projecting radially inward from the 1136. In addition, the locking ring has two further radially inwardly projecting lobes 1136. 140. The two flexible arms 1136 each protrude proximally and extend radially. At its upper proximal end, a flexible arm 1136 has an outwardly extending snap lug 1142. has a front surface running substantially radially.

[0290] In other examples, the ring may have different cross-sectional geometries and may have a number of legs, from single to multiple. It is also possible.

[0291] On the distal side of the closing ring 1132, the locking ring 1106 has four distally extending Each flexible arm 1146 has a slight incline a snap lug 11 on its distal end extending radially inward with a distal wall 1150 48, whereby each flexible arm 1146 has a sharp tooth profile on its distal end. The degree of flexibility of the arms 1146 is such that the sliding force of these arms 1146 exceeds the should be matched to the spring constant of spring 1308 so that is less than the safety shield spring force. It is important to state that occlusion after injection and removal of the device from the skin are always This is discussed below when describing the functionality. .

[0292] 72a and 72b show an example of a syringe holder 1110. 110 has the purpose of receiving and holding a pre-filled syringe 1204 within a housing 1108. Syringe holder 1110 allows different types of syringes with different volumes of medication to be placed in device 1. 010 without the need to substantially change the dimensions of the other components. Thus, different sizes for syringe holder 1110 provide compatibility with different types of syringes. It should be.

[0293] The syringe holder 1110 provides a longitudinal tubular body 1152. At its proximal end, the tubular body 1152 has four protruding flexible arms, the first of two opposing arms 1154 Each arm 1154 of the pair has a radially inwardly projecting lug 1156 that forms a gripping element. Such as inclined lugs 1160 supported by cross lateral support ribs 1162. Each arm 1158 of the second pair of two opposing arms 1158. An angled lug 1160 Its proximal portion includes a sloped surface 1164. The distal end of the syringe holder 1110 has two recesses 1164. The collar 1166 has an angled collar 1166 with rounded edges 168 on opposite sides thereof. 1170 and a longitudinal section 1172 connected by a transition section Radial portion 1170 is specifically configured to hold syringe holder 1110 in place to facilitate assembly. The transition portion of the longitudinal portion 1172 leads into the housing 1108 together with the launcher 1200. The edges can be rounded or chamfered.

[0294] 73a-73c show different views of the housing 1108. The housing 1108 holds the device 1010 The housing 1108 has the purpose of forming the body 1012 of the device. The housing 1108 is made of a stable, rigid, transparent or opaque material. If not entirely transparent, the housing may be made of a transparent material, which may allow the actual state of the drug and device to be seen. The drug may be formed with a cutout or transparent window for viewing the drug to allow visibility to the user. The housing 1108 is formed by a longitudinal tubular member 1174 having a proximal end The tubular member has a front surface 1176 with a closed sinus-shaped profile. Near 176, the housing 1108 includes two U-shaped lateral projections 1178, the lateral projections The portions 1178 are disposed opposite each other and protrude radially outward. 1178 is used to hold the end cap body 1052 in place on the housing 1108 before use. 66a. At its distal end, the housing has a circular front face 1180. In substantial longitudinal alignment with the raised portion 1178, the housing 1108 has two opposing lateral In the area between the distal end and the notch 1182, the housing has two pairs of protrusions. It is integrally formed with the protruding knob 1184. The protruding knob 1184 can also have alternative shapes. The protruding knob 1184 functions to provide an anti-rocking feature for the device 1010 on a flat surface. Each pair of knobs 1184 is aligned with a respective lateral notch 1182.

[0295] Inside the housing 1108, a ring structure 1186 is provided. The ring structure 1186 is made up of a pair of The tubular member 1174 is integrally connected to the tubular member 1174 using opposing rigid connecting arms 1188. The connecting arm 1188 is a stable connecting arm with three longitudinal connecting ribs and one transverse connecting rib. The size of the connecting rib and the E-shaped cross section is determined by the size of the housing 11. This joint geometry should provide structural rigidity to the component when it is molded. Additionally, the ring structure 1186 opens distally and is important for material flow. two V-shaped notches 1192 terminating proximally in a radially circular base surface 1194; The syringe holder 1110 has a longitudinal apex 1190. The V-shaped notch 1192 is The longitudinal direction is provided to receive an inclined lug 1160 with a support rib 1162. The collar 1196 extends proximally from the base surface 1194. This geometry is During actuation, it guides the movement of the safety shield 1104 and also secures the syringe holder 1110 to the housing 110. 8. The collar 1196 is adapted to actuate the injection device as discussed below. The stiffness criteria are used to limit the loads applied through the vessel 1200.

[0296] 74 and 75 show perspective views of the rigid needle shield 1202 and its insert 1212. The rigid needle shield 1202 has a tubular portion with an open distal end 1216 and a closed proximal end 1218. At its front, the rigid needle shield 1202 is formed by a lateral gripping rib 1214. Near its distal end, a rigid needle shield 1202 is formed. has two opposing rectangular through holes 1222.

[0297] The insert 1212 shown in FIG. 75 is made of a flexible, deformable material. Pressurize the rigid needle shield 1202 so that the needle 1212 is held firmly therein. The insertion portion 1212 engages with the rectangular through-hole 1222 of the rigid needle shield 1202. It has an annular collar 1224 near its distal end that mates with the distal end of the septum.

[0298] 76 shows a syringe 1204. The syringe 1204 has a hollow, open distal end 1232. A cylindrical glass body 1230 is formed, the open distal end 1232 of which is formed by two flat, opposing At its proximal end, the cylindrical gasket is surrounded by a circumferential annular collar 1234 having side surfaces 1235. The lath body 1230 is formed with a rounded tapered portion 1233, forming a hollow conical glass portion 12 36. The hollow conical glass section 1236 terminates in a proximal head 1238, The needle 1206 with a sharp needle tip 1240 is firmly received therein.

[0299] Figure 77 shows a stopper element 1210 formed from a flexible material, such as rubber. At its proximal end, the stopper element 1210 has a smooth cylindrical outer peripheral surface 1242 and a cylindrical outer peripheral surface 124 2, the stopper element 1210 is slidably engaged with the inner circumferential surface of the hollow cylindrical glass body 1230 in a liquid-tight manner. The outer diameter of the syringe 1230 is adapted to fit the inner diameter of the hollow cylindrical glass body 1230 of the syringe. On the distal portion of the face, the stop element 1210 forms three circumferential sealing ribs 1244. The stopper element 1210 has a closed proximal end 1246 and four circumferential annular recesses. It has a cup shape with an open distal end 1248 .

[0300] Referring now to the components of the power unit, FIGS. 78a and 78b show plunger 130. 2 in different perspective views. The plunger 1302 is inserted into the longitudinal pipe-shaped hollow element 13 20, a hollow element 1320 having a plunger head 1322 at its proximal end. It can be formed integrally with hollow element 1320 or can be formed as a separate piece. The plunger head 1322 may be a cylindrical portion 1323 with an enlarged outer diameter in the example shown. 324. This enlarged plunger head 1322 is only for 1 ml, e.g. Used for larger syringes, e.g., 1 ml, with a drug volume of 2.25 ml. For smaller syringes with a drug volume of 1, the enlarged plunger head 1322 may be omitted, and plunger 1302 may simply have a straight cylindrical shape at its proximal end. A pair of opposing rectangular through-holes 1326 in the middle of the plunger 1302 form a hollow core. At the distal end, the hollow element 1320 has a periphery of the hollow element 1320. The plan has four longitudinal ribs 1328 spaced equidistantly about the circumference. The distal end of the jar 1302 provides two grooved channels 1330 opening into a distal end face 1331. 13B, each having a tapered portion 1332 and a longitudinal end 1334.

[0301] 79a and 79b depict the shield retention trigger element 1306. Shield Retention Trigger Element 1306 has a radially annular collar 1342 integrally formed at its proximal end. The hollow bushing 1340 is formed by an open end. The two opposing notches 1344 define the entire housing 13 40 provides a longitudinal guide surface 1346 extending through the

[0302] 80a and 80b depict a shield retention indicator 1310. 10 is a visible indicator for the actual state of use, specifically when the device 1010 is delivering a drug. The purpose of this is to provide an indicator that the shield has already been used to Indicator 1310 has an annular shape with radially inwardly projecting ribs 1352 on its proximal inner circumferential surface. Moreover, the annular cylindrical body 1350 includes two opposing proximal extending The flexible arm 1354 has a first portion 1356 running longitudinally and a second portion 1357 extending longitudinally. 358 is inclined radially inward, and the third portion 1360 is inclined longitudinally but inclined relative to the first portion 13 56. At its proximal end, each arm 1354 has , and has a retaining projection 1362 extending radially outward.

[0303] At its intermediate portion, the annular cylindrical body 1350 has a radially outwardly extending annular flange 1364 Two opposing arcuate wall members 1366 extend distally from flange 1364. The outer periphery 1368 of these arcuate wall members 1366 may be colored with a signal color and / or a signal visibility pattern. Equipped with a

[0304] 81a and 81b depict the holder 1312 of the power supply unit 1300. 2 acts as a control member that includes multiple control functions of the power supply unit 1300. 1370. On two opposite sides, the cylinder 1370 has a long It includes a U-shaped notch 1372 that forms a longitudinally flexible arm 1374. Arm 1374 is integrally connected to hollow cylindrical body 1370 at its distal end 1376. At its distal end, the flexible arm 1374 includes a chamfered radially outward projection 1378, The opposite side has a corresponding chamfered radially inward projection 1380. 1370 is angled 90° with respect to the flexible arm 1374 formed by the notch 1372. The rotated area is provided with two opposing longitudinal notches 1382. 82 extend approximately the same longitudinal extent as the U-shaped notch 1372. In an area of ​​about one-third of the longitudinal length of the notch 1382, the cylindrical body 1370 has a notch 1383. 82 includes a lateral projection 1384 that laterally bridges the lateral projection 1384.

[0305] At its proximal end, the cylindrical body 1370 is integrally formed with the cylindrical body 1370 and has a hollow cylindrical body 13 70. The proximal anterior surface of the stent 70 is inclined at an angle of approximately 45° to the stent 70. These flexible arms 1390 are connected to a ring-shaped head 1392. The shaped head 1392 is a bushing with a cylindrical portion 1394 and a proximal flange portion 1396. The head 1392 may be integrally formed with the flexible arm 1390 or may be attached to the flexible arm. 1390 as separate pieces rigidly connected to the frame 1390, for example, by means of an intermediate connecting ring. It is possible.

[0306] At its distal end, the cylindrical body 1370 includes an outer It is formed with two opposing groups of longitudinal ridges 1400, 1402, 1404. Distal from the edges 1400, 1402, 1404, the cylindrical body 1370 has an increased diameter. The cylindrical portion 1406 has an increased diameter. The cylindrical portion 1406 has two opposing The cylindrical body 1370 includes a rounded transverse notch 1408. The notch 1408 is 1382. The remaining unnotched wall cross section of cylindrical section 1406 is , two longitudinal protrusions extending slightly radially outward and having a rectangular shape when viewed from the side. These projections 1410 each have a transverse extension at their midpoint. It has a slot 1412.

[0307] Figures 82a and 82b depict the rotary click element 1314. The rotary click element is The rotary click element 1314 is provided to vary the drive force of the screw 1304. a hollow distal surface formed with a proximal front surface 1422 and a distal surface formed with an annular apex of shark teeth 1424; The shaft is formed by a cylindrical bushing 1420. Radially inward from the top of the shark teeth 1424 The rotary click element 1314 includes two opposing cylindrical walls 1426. 1426 is divided by a transverse notch 1428. On the inner circumferential surface, a bushing 1420 1304 includes a protrusion for engaging the main spring 1304 for general rotation.

[0308] 83a and 83b depict the distal end cap 1316 of the device 1010. The cap 1316 includes an end cap body 144 formed from a distal plate that closes the distal opening of the housing 1108. 0. Therefore, the end cap body 1440 has the engagement projections 1444 in their vicinity. The distal end of the flexible arm 1442 is formed with two protruding flexible arms 1442. The arms 1442 are configured as snap hooks that engage with corresponding openings 1182 in the housing 1174. Additionally, radially inward from the flexible arm 1442 is the end cap body 144 0 is formed with a hollow cylinder 1446. The hollow cylinder 1446 extends radially outward. Additionally, the hollow cylindrical body 1446 has two opposing nose elements 1448 extending longitudinally. The hollow cylindrical body 1446 has two proximal slopes 1450 extending from the end cap 1444. On the surface of the body 1440, the top of the shark tooth 1424 formed on the rotary click element 1314 Further tips of shark teeth 1452 are provided which are adapted to engage the longitudinal The cylindrical rod member 1454 is attached to the end cap body 1440 at the center of the top of the shark tooth 1452. Extends proximally from the face.

[0309] The assembled state of the device 1010 will now be described with reference to Figures 84a and 84b. This also refers to the initial state of the device 1010, i.e., the state of the device as it is delivered to the user. When the device 1010 is assembled, the end caps 1050 are attached to the longitudinal housing 110. 8, end cap 1050 has its retaining rib 1061 and corresponding The syringe 1204 is held in a U-shaped protrusion 1178 of the housing 1108 by a recess that fits into the syringe. The syringe holder 1110 is held within the ring structure 1112 of the housing 1108. 186. Additionally, syringe 1204 has its annular collar 1234 or flange The head 1392 is used to apply pressure to the ring structure 1186 of the housing 1108 in a proximal direction. When compressed, the flexible arm 1390 holds the syringe 1204 in place within the syringe holder 1110. The rigid needle shield 12 acts as a spring means to provide a spring force in the axial direction to hold the needle in place. 02 engages the hollow conical glass part 1236 with the insert 1212. 212 safely covers the needle 1206, maintaining the sterility of the contact needle and the contained medication. As can be seen, the exterior surface of the tubular member 1214 with the lateral gripping ribs 1220 is The blade washer 105 is engaged by the flexible lobe 1084 of the washer 1054. 4 is held within the end cap 1050 using a cap cover 1056.

[0310] Additionally, Figure 84b shows the ring-shaped body 1112 of the safety shield 1104. The rod 1104 is supported by end caps 1050 via longitudinal arms 1114, 1116. Shield retention trigger element 1306 is pressed against the force of shield spring 1308 by a long Acts as a junction between the manual arms 1114, 1116 and the shield spring 1308 The proximal end of the shield spring 1308 is secured to the flange 134 of the shield retention trigger element 1306. 2, and the distal end of the shield spring 1308 is engaged with the front of the shield retention indicator 1310. Apply pressure to lunge 1364.

[0311] The shield retention indicator 1310 also responds to the compressed shield spring 1308 and the resulting force. Regardless, it is held in its axial position by its arm 1354. 4 reach through longitudinal notches 1382 in retainer 1312 and their radial retaining projections behind the lateral projection 1384 that bridges the notch 1382 of the retainer 1312 and the portion 1362. Moreover, in this state, the arm 1354 moves radially. The inwardly disposed plunger 1302 prevents the arms 1354 from bending radially inward. ingredient.

[0312] The plunger 1302 holds the main spring 1304 in compression. The end presses against the proximal end of plunger 1302, and plunger head 1322 presses against the plunger The plunger head 1322 is fixed to the syringe 1302 near the stopper element 1210. 12. The hollow glass body 1230 of the vessel 1204 can be seen to be slidably received within the hollow glass body 1230 of the vessel 1204. FIG. 84 b shows the medication 1208 as a liquid column contained within the syringe 1204 .

[0313] The distal end of the main spring 1304 protrudes from the plunger 1302 and engages the rotary click element 131. 4, in which the distal end of main spring 1304 is also non-rotatably engaged. The rotary click element 1314 then slides into the hollow cylindrical body 144 of the distal end cap 1316. 6, and the two shark tooth formations 1424 and 1452 engage with each other. Relative rotation of the locking element 1314 and distal end cap 1316 provides an audible or Produces a noticeable clicking sound.

[0314] As seen on the right side of Figure 84b, the cylindrical post member 1454 is located inside the hollow interior of the main spring 1304. 1304 extends proximally into the main spring 1304 and acts as an axial guide element for the compressed main spring 1304. The distal end cap 1316 is inserted into the housing 1108, and the flexible arm 1442 These radially outwardly pointing engagement protrusions 1444 engage with the lateral notches 1182 in the housing. However, the protrusions 1444 are urged against the spring force that causes the distal end cap 1316 to move. Hold in place.

[0315] From this fully assembled initial position, device 1010 according to this example of the invention operates as follows: It is used as follows.

[0316] To remove the end cap 1050, the end cap 1050 is removed from the housing 1108. The tamper label 1059 is twisted in the direction of the arrow-shaped opening 1059. The twisting force is exerted by the retention provided on the inner surface of the end cap body 1052. Overcomes the interaction between the U-shaped protrusion 1178 on the housing 1108 that receives the rib 1061 The twisting motion must be large enough to twist the front surface of the cavity-shaped housing 1108. 1176. The safety shield 1104, when ready for use, is Due to the fact that the end cap 1050 is biased against the end cap 1050 by the spring 1308, The twisting action of the cap 1050 is supported by the biasing force of the shield spring 1308. This overcomes the initial resistance also provided by the tamper label 1016. The movement of twisting off the end cap 1050 is then supported by the spring force, allowing the user to twist off the end cap. During removal of the end cap 1050, the seal The dowel spring 1308 supports the twisting action of the end cap 1050, while the shield spring 1308 expands axially, causing the safety shield 1104 to extend to its full extent over the needle 1206. The safety shield 1104 is then pulled away from the housing 1108 until it finally reaches its final position. 04. Additionally, while removing the end cap 1050, the blade washer 105 The rigid needle shield 1202 is gripped by the four lobes 1084 at its insert 1212. The syringe 1204 is then pulled out of the hollow conical glass portion 1236 together with the syringe 1204. The needle 1206 with its needle tip 1240 is inserted into the ring-shaped body 1112 of the safety shield 1104. It is exposed inside.

[0317] In other words, the removable end cap 1050 is secured to the housing by the U-shaped protrusion 1178. The body 1108 is shown as being U-shaped, but may be of many other geometric shapes. Its function is to limit the middle of U. This means that when pulled, it can be removed. Set the tension for the removable end cap 1050. 1050 has a rib 1061 in the middle of the arrow notch that contacts the middle of the U-shaped protrusion 1178. The angle at which the pulling force is stopped and the pulling force is not so large when the pulling force is large. Each aligned angle. Function and angle of the plastic area of ​​the arrow notch 1059 By combining these, the pulling force can be adjusted to the required level. The side of 1178 is needed to begin removing the removable end cap 1050 The U-shaped protrusion 1178 and the restraining rib are rotated and tilted to adjust the initial torque. 1061 longitudinal rotation restraint.

[0318] 85a and 85b show the present invention with the end cap 1050 just completely removed. 85a shows a longitudinal cross-sectional view of a drug delivery device according to the example of FIG. 61; 85b is a longitudinal section along plane A shown in FIG. 61, and FIG. 85c is a longitudinal section along plane B shown in FIG. It is a surface.

[0319] In this state, the safety shield 1104, together with its ring-shaped body 1112, is attached to the housing 1108. The user can see that the safety shield indicator 1102 with its signal color protrudes from the housing. The shield spring 1308 is partially relaxed but still The main spring 1304 is still fully compressed. The main spring 1304 is supported by a flexible arm 1374 of the retainer 1312 which is beveled radially inward. The protrusions 1380 engage within opposing rectangular through-holes 1326 of the plunger 1302. Due to the fact that the plunger 13 02 is held in an axial position against the spring force of the main spring 1304, preventing the expansion of the main spring 1304. The power supply unit 1300 is pressurized.

[0320] The possible range of axial movement of the safety shield 1104 is determined by the tilted rod of the syringe holder 1110. longitudinal arms 1114, 1116, each of which receives a guide 1160; This is determined by the length of the slotted through-hole 1124. This can also be achieved by means of protrusions guided in longitudinal slots such as in 1108. As discussed above, in the assembled state, syringe holder 1110 is housed within housing 1108. is held firmly in place.

[0321] To use the device 1010, as shown in Figures 85a and 85b, the device on the patient's skin S at the location where the drug is intended to be injected, for example, into the patient's thigh. The device 1010 is then pressed proximally by the user onto the patient's skin S. As a result, the safety shield 1104 is pressed against the biasing force of the shield spring 1308. While being pressed into the housing 1108, due to the pushing motion of the device, the needle tip 1240 The patient's skin S is pierced and the needle 1206 is pressed through the patient's skin S into the patient's tissue. Finally, when the safety shield 1104 is pushed completely down into the housing 1108, the safety The shield 1104 is secured to its ring-shaped body 1112 against the proximal front face of the connecting arm 1188. , and the connecting arm 1188 connects the housing 1108 to the ring structure 1186. At this point, the safety shield 1104 can move further axially into the housing 1108. There is no activity and the safety shield 1104 is blocked.

[0322] This position, with the safety shield 1104 fully depressed, is shown in Figures 86a and 86b. The drug delivery device is just fully pressed against the patient's skin and drug delivery just begins. Draw a longitudinal cross section of the device in this state.

[0323] In this state, the two flexible arms 1136 of the locking ring 1106 are secured together by their snaps. Engage the plug 1142 to close the corresponding opening in the ring-shaped body 1112 of the safety shield 1104 1128, thereby locking the locking ring 1106 against the safety shield 1104. The connection is rigid and yet provides general axial movement during use. The full shield display 1102 has a ring-shaped body 1112 substantially received within a housing 1108. 1108. Therefore, it is mainly covered by the housing 1108.

[0324] As seen in FIG. 86b, by pressing the safety shield 1104 into the housing, The two longitudinal arms 1114, 1116 are inclined. The distal end of the stent is moved distally while being guided by the engagement of the lug 1160 and the slot 1124. Thereby, the shield holding trigger 1306 is pressed against the compressive force of the shield spring 1308. The shield holding trigger 1306 is moved in the distal direction by the shield holding trigger 1306. The flexible arm 1372 of the retainer 1312 is fitted with a chamfered radially outward projection 1378. As a result, the flexible arm 1372 is moved distally to a radius of The plunger 1302 is free to bend outward in the proximal direction. Due to the force and the chamfered design of the radially inward projection 1380, the plunger 1302 The flexible arm 1324 is then guided by the corresponding chamfered rim of the through hole 1326. The piston 1374 is forced radially outward by the plunger 1302, thereby opening 1326. The plunger 1302 then moves proximally, disengaging from the stopper element 1326. 210 and displaces the stopper element 1210 proximally within the vitreous body of the syringe 1204. , initiating delivery of the drug through the needle 1206 and into the patient's tissue, i.e., extrusion. It is possible.

[0325] 87a and 87b show longitudinal views of the drug delivery device in an intermediate state when the drug is being delivered to the patient. A cross-sectional view is shown in which the plunger 1302 is in contact with the stopper element 1210 and is inserted through the needle. To expel the medication, the plunger 1302 is moved a certain distance within the syringe 1204. In Figure 87b, the flexible arms 1374 are bent radially outward. , it can be clearly seen that the plunger 1 302 is moved proximally under the spring force of main spring 1304 which tends to expand.

[0326] Finally, the main spring 1304 pulls the plunger 1302 and thereby the stopper element 1210 is driven in close proximity to the rounded taper 1233 of the syringe 1204. 88b shows a longitudinal cross-sectional view depicting this state as drug delivery nears its end. In this state, the distal end of the plunger 1302 is in contact with the flexible end surface 1331 of the holder 1312. It just passes the proximal side of the radially inwardly extending projection 1380 of arm 1374. When the end face 1331 of the plunger 1302 passes the proximal side of the protrusion 1380, the flexible adapter The arm 1374 can bend radially inward behind the end face 1331. This radial inward movement of the flexible arms 1374 causes the proximal front of the flexible arms 1374 to move in a radially inward direction. The device impacts the outer periphery of the distal end of the transducer 1302, producing certain audible and / or tactile signals to the user. may be provided to the user.

[0327] Additionally, as seen in FIG. 88b, plunger 1302 is inserted proximally within syringe 1204. Near the end of drug delivery, plunger 1302 is nearly fully advanced to its distal end. The end surface 1331 also passes through the proximal end of the flexible arm 1354 of the shield retention indicator 1310. The plunger 1302 thus engages the flexible arm 13 of the shield retention indicator 1310. 54 radially inwardly releases the shield. As a result, the compressed shield spring 1308 Due to the force, the chamfered retaining protrusion 1362 of the arm 1354 contacts the retainer 1312. sliding along the proximal anterior surface of lateral projection 1384, which laterally bridges notch 1382 This causes the flexible arms 1354 to bend inward, being forced radially inward. The flexible arm 1354 is now free to pass distally through the lateral projection 1384. The compressed shield spring 1308 tends to expand, so the shield spring 1308 The impact of the cold spring 1308 against the distal end cap 1316 creates an audible and / or tactile shock. Move the shield hold indicator 1310 distally until it provides a visual cue to the user.

[0328] Additionally, opposing arcuate wall members 1366 with their outer periphery having a signal color are flexible. It fits into the free surrounding space between the arms 1442. As mentioned above, the housing 1108 is transparent. The label 1014 is formed from a material substantially spaced from the proximal end of the housing 1108, e.g. For example, the distance is 6 to 20 mm, which allows the user to see inside the housing 1108. A circular transparent window 1198 is provided through which the

[0329] In the state shown in Figures 84a, 84b to 87a, 87b, the window is transparent. As shown in FIG. 1b, the shield retention indicator 1310 is held in place by the radially inward movement of the arms 1354. As soon as it is released by the release and is forced distally by the shield spring 1308, An arcuate wall member 1366 with a colored or patterned peripheral surface 1368 provides a barrier to the surrounding free space. and view through the circular transparent window 1198, thereby allowing the user to see the drug delivery. In another example, this may be a label or If the housing creates opaque and transparent areas, it can be one or more windows. .

[0330] 89a and 89b show longitudinal views of the drug delivery device when it has fully delivered the drug to the patient. The main spring 1304 is substantially released, stopping the plunger 1302. The rounded taper 1233 of the syringe 1204 fits perfectly against the inner surface of the syringe element 1210. The drug is completely expelled through the needle 1206 into the patient's tissue. The shield retention indicator 1310 is held completely at the distal end by the shield spring 1308. It is pressurized and visible to the user through window 1198 .

[0331] The user is notified by audible and / or tactile signals and by a visual indication through window 1198. The user then removes the device 1010 from the skin in an axial direction, knowing that drug delivery is complete. The device 1010 is removed by retracting the needle from the tissue. While removing the device 1010 from the skin, i.e., withdrawing the needles from the tissue, The safety shield 1104 is positioned such that the safety shield 1104 completely covers the needle tip 1240. The needle 1206 remains in permanent contact with the patient's skin S until it protrudes above the needle 1206. The needle shield is brought closer to the shield spring 1308 along with the shield retention trigger element 1306. This is due to the fact that the nozzle 1104 is pushed out of the housing 1108 in the radial direction.

[0332] 90a-90c show the drug delivery device after removal from the patient's skin and locking in place after use. 86a shows different views of the state when the lock ring 1106 (see FIG. 86a) is permanently fastened. A safety shield 1104 is permanently attached to the housing 1108. Its flexible arms 1136 to engage the corresponding opening 1128 within the ring-shaped body 1112. The gasket 1106 prevents the safety shield 1104 from any further distal movement within the housing 1108. In other words, the locking ring 1106 prevents the safety shield 1104 from The safety shield 1104 thereby prevents the device from being pushed back into the Any contact with the patient or practitioner will result in the needle tip becoming contaminated with the patient's blood. Safely cover the needle 1206 with 0.

[0333] The blockage against any distal movement of the safety shield 1104 is provided by the locking ring 110 This is achieved by four flexible arms 1146 formed on the distal side of the device 10. 10 permanently attaches arm 1136 with safety shield 1104, While being removed from the insertion site on the patient's skin, the safety shield 1104 is secured to the shield spring. When the safety shield 1104 is pushed out of the housing 1108 by the force of 1308, the safety shield 1104 locks. This pulls the lock ring 1106. This causes the lock ring 1106 to The flexible arm 1146 is connected to the ring structure 1186 formed integrally within the housing 1108. Finally, the flexible arms 1146 are moved across their distal walls 1150. and passes through the proximal leading edge of the ring structure 1186 of the housing 1108 and bends radially inward. The four flexible arms 1146 with their distal walls 1150 thereby form a ring. The flexible arm 1186 snaps radially inward in front of the proximal face of the flexible arm 1186. The ring 1146 is a locking strap between the safety shield 1104 and the proximal anterior surface of the ring structure 1186. Using the locking ring 1106, the safety shield 1104 is secured to the housing. 1108. Additionally, the safety shield 1104, the safety shield 1104 uses the radially distal surface of the angled lug 1160 to are blocked from engaging within the longitudinal slots 1124 of the arms 1114, 1116 Therefore, any further proximal movement out of the housing 1108, i.e., pulling out of the housing, It is also secured against being pulled out.

[0334] This prevents any further use of the device 1010. The end cap 1050 is blocked by the exit and lock safety shield 1104. It cannot be screwed or pressed onto the housing 1108. The user can access the device through the window 1198. The colored wall segments of the colored shield indicator 1102 and the shield retention indicator 1310 You can see No. 1366.

[0335] The device 1010 according to the above example of the invention has, in particular, the following advantageous features: The device 1010 includes three different pre-assembled sub-assembly syringe units 110. 0, can be easily assembled from a pre-filled syringe 1200 and a power supply unit 1300 can. The pre-filled syringe 1200 can be fitted with different syringes as needed to fit the syringe holder 1110. It can be provided in a variety of shapes and sizes. The distal end cap 1050 can be easily removed from the housing 1108 and twisted therein. The removal operation is supported by the action of the shield spring 1308. During use of the device, the device may provide audible and / or tactile and / or visible signals of different states of operation. It offers multiple possibilities to give Unless drug is being delivered, the user must not use any visual indicators until drug delivery is complete. This state can be seen through window 1198, which does not show any Drug delivery is initiated by pressing the device against the patient's skin. Therefore, once started, there is no risk of stopping drug delivery. This is because the device is used multiple times. Prevent. The device is easy to use as it does not have a separate trigger element, such as a button. Activation is intuitive. The device with its safety shield 1104 is placed against the patient's skin. This is brought about only by applying pressure.

[0336] In summary, the device provides an easy assembly structure that can be used with different types of syringes. The device is easy, intuitive, and error-free to use. The device provides several feedback signals to the user. It should be noted that the present invention includes the following aspects. [Aspect 1] 1. An automated medication delivery device for dispensing a fluid product, comprising: a longitudinal housing extending along a longitudinal axis and having a proximal end near a dispensing location, a distal end opposite the proximal end, and a hollow interior; a removable cap attachable to the proximal end of the housing; a syringe assembly disposed in a mounting position inside the housing, the syringe assembly having a hollow syringe body and a needle formed with the hollow syringe body containing the fluid product; a drive mechanism actuable by a trigger element to initiate dispensing of said fluent product; Including, the drive mechanism is operably coupled to a safety shield movable within the longitudinal housing; the safety shield is biased to a proximal position where it projects from the proximal end of the longitudinal housing to cover the tip of the needle, and the safety shield is movable to a distal position where the needle is exposed for injection; The device further includes a feedback mechanism that provides a user with visual feedback indicating an actual state of operation, the feedback mechanism including a visual indicator that appears within a transparent window on the distal end of the housing. [Aspect 2] 2. The device of embodiment 1, wherein the visual indicator appears within a transparent window on the distal end of the housing to indicate the end of injection. [Aspect 3] 3. The device of any one of aspects 1 to 2, wherein the visual indicator moves distally to appear within the transparent window. [Aspect 4] 4. The device of any one of aspects 1-3, wherein the visible indicator is formed by a radially inner indicator component and a radially outer indicator component biased into an indicator position by an indicator spring, and the indicator is released to the indicator position shortly before the predetermined dose of the drug has been delivered to the patient. [Aspect 5] The device of claim 4, wherein the radial external display component includes a visible surface and the radial internal display component interacts with the housing or an additional housing part to provide an audible and / or tactile signal. [Aspect 6] Aspect 6. The device of any one of aspects 1-5, wherein the window is transparent around the entire periphery of the device such that the visible indicator appears at angles ranging up to 360°. [Aspect 7] The device of embodiment 6, wherein the device includes a distal end cap closed by a distal face, the distal end cap formed from a transparent material to provide the transparent window. [Aspect 8] 8. The device of embodiment 7, wherein the distal surface is formed from a transparent material. [Aspect 9] A device as described in any one of aspects 1 to 8, wherein a locking ring is provided in an initial position within the longitudinal housing, the locking ring locking to the safety shield during actuation, and the locking ring blocking distal movement of the safety shield when the safety shield covers the needle after the fluid product is finally dispensed and the automated drug delivery device is removed from the injection site. [Aspect 10] The device of aspect 9, wherein the locking ring in its initial state is held by a receiving component that holds a syringe holder, the locking ring engages with the safety shield after the safety shield is pushed distally, the locking ring is moved proximally together with the safety shield when the automatic drug delivery device is removed from the injection site, and the locking ring blocks any movement of the safety shield in the distal direction relative to the receiving component when covering the needle after use. [Aspect 11] 9. The device of any one of aspects 1 to 8, wherein the safety shield has at least one longitudinal arm extending distally guided within the longitudinal housing, the safety shield interacting with a safety shield spring that biases the safety shield proximally via the at least one longitudinal arm, the safety shield spring supported between a shield retention trigger member and a shield retention indicator member, the shield retention trigger member supporting a proximal end of the safety shield spring and applying a biasing force to the distal ends of the longitudinal arms of the safety shield, and the shield retention indicator member supporting the distal end of the safety shield spring. [Aspect 12] The device of aspect 11, wherein when the safety shield is pressed distally to initiate dispensing of the fluid product, the safety shield moves the shield retaining trigger member distally so that it compresses the safety shield spring, and after a predetermined stroke of the safety shield, the shield retaining trigger member causes the plunger to release from the retainer and move proximally under the biasing force of a drive spring to dispense the fluid product from the syringe body through the needle. [Aspect 13] The device of aspect 12, wherein the shield retention indicator includes at least one longitudinal retention arm, the shield retention indicator is held by the at least one retention arm in an invisible position where the display surface is not visible through the housing by the retainer, the at least one retention arm is held unless the plunger reaches a predetermined dispensing position, the plunger causing the at least one retention arm to be released from the retainer when it reaches the predetermined dispensing position, and after the at least one retention arm is released, the shield retention indicator is pressed by the safety shield spring to a visible position where its display surface is visible through the housing. [Aspect 14] The device of aspect 13, wherein the shield indicator member is released and moved to a visible position, the safety shield is biased to a position covering the needle tip, the shield retention indicator prevents distal movement of the shield retention trigger member, and the shield retention trigger member prevents distal movement of the safety shield. [Aspect 15] Aspects 12-14: The device of any one of aspects 12-14, wherein after the plunger is released from the holder, proximal movement of the safety shield is prevented until the plunger reaches a predetermined dispensing position. [Aspect 16] 1. An automated medication delivery device for dispensing a fluid product, comprising: a longitudinal housing extending along a longitudinal axis and having a proximal end near a dispensing location, a distal end opposite the proximal end, and a hollow interior; a removable cap attachable to the proximal end of the housing; a syringe assembly disposed in a mounting position inside the housing, the syringe assembly having a hollow syringe body and a needle formed with the hollow syringe body containing the fluid product; a drive mechanism actuable by a trigger element to initiate dispensing of said fluent product; Including, the drive mechanism is operably coupled to a safety shield movable within the longitudinal housing; the safety shield is biased to a proximal position where it projects from the proximal end of the longitudinal housing to cover the tip of the needle, and the safety shield is movable to a distal position where the needle is exposed for injection; The device, wherein the safety shield has at least one longitudinal arm extending distally and guided within the longitudinal housing, the safety shield interacts with a safety shield spring that biases the safety shield proximally via the at least one longitudinal arm, the safety shield spring being supported between a shield retention trigger member and a shield retention indicator member, the shield retention trigger member supporting a proximal end of the safety shield spring and applying a biasing force to the distal ends of the longitudinal arms of the safety shield, and the shield retention indicator member supporting the distal end of the safety shield spring. [Aspect 17] The device of aspect 16, wherein when the safety shield is pressed distally to initiate dispensing of the fluid product, the safety shield moves the shield retaining trigger member distally so that it compresses the safety shield spring, and after a predetermined stroke of the safety shield, the shield retaining trigger member causes the plunger to release from the retainer and move proximally under the biasing force of a drive spring to dispense the fluid product from the syringe body through the needle. [Aspect 18] The device of aspect 17, wherein the shield retention indicator includes at least one longitudinal retention arm, the shield retention indicator is held by the at least one retention arm in an invisible position where the display surface is not visible through the housing by the retainer, the at least one retention arm is held unless the plunger reaches a predetermined dispensing position, the plunger causing the at least one retention arm to be released from the retainer when it reaches the predetermined dispensing position, and after the at least one retention arm is released, the shield retention indicator is pressed by the safety shield spring to a visible position where its display surface is visible through the housing. [Aspect 19] The device of aspect 18, wherein the shield indicator member is released and moved to a visible position, the safety shield is biased to a position covering the needle tip, the shield retention indicator prevents distal movement of the shield retention trigger member, and the shield retention trigger member prevents distal movement of the safety shield. [Aspect 20] Aspect 20. The device of any one of aspects 17-19, wherein after the plunger is released from the holder, proximal movement of the safety shield is prevented until the plunger reaches a predetermined dispensing position.

Claims

[Claim 1] 1. An automated medication delivery device for dispensing a fluid product, comprising: a longitudinal housing extending along a longitudinal axis and having a proximal end near a dispensing location, a distal end opposite the proximal end, and a hollow interior; a removable cap attached to the proximal end of the housing; a syringe assembly disposed in a mounting position inside the housing, the syringe assembly having a hollow syringe body and a needle formed with the hollow syringe body containing the fluid product; a drive mechanism actuable by a trigger element to initiate dispensing of said fluent product; Including, the drive mechanism is operably coupled to a safety shield movable within the longitudinal housing; the safety shield is biased to a proximal position where it projects from the proximal end of the longitudinal housing to cover the tip of the needle, the safety shield being movable to a distal position where the needle is exposed for injection, the movement of the safety shield to the distal position actuating the drive mechanism to initiate dispensing of the fluid product; The device, wherein the removable cap is axially retained on the proximal end of the longitudinal housing by engagement of a retaining element between the cap and the longitudinal housing, the removable cap retaining the safety shield between the proximal position and the distal position, the retaining element being engaged and disengaged by rotating the cap relative to the longitudinal housing to allow axial movement of the cap relative to the housing to remove the cap, the axial movement of the cap relative to the housing being supported by the biasing force applied to the safety shield.

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