Automatic inserter for handheld pen injection system

Abstract

An automatic inserter for a pre-filled syringe system includes an elongate body having a longitudinal bore and a central longitudinal axis and configured to receive the pre-filled syringe introduced through a proximal tip of the body within the bore, the inserter further including a needle cap holder configured to hold the pre-filled syringe within the bore, the needle cap holder is connected to the distal tip of the inserter body by a hinge. The cap holder is configured to rotate about the hinge from a first closed position in which the cap holder accommodates the needle cap prior to injection to a second open position in which the needle cap is removed from the pre-filled syringe and held by the cap holder, the latter being connected to the inserter body by the hinge, the cap holder being configured to rotate about the hinge from a first closed position in which the cap holder accommodates the needle cap prior to injection to the second open position in which the needle cap is prepared for an injection step.

Description

Technical Field

[0001] The present invention relates generally to accessories for pre-filled syringe systems and, more particularly, to automatic inserters for pre-filled syringe systems or devices. Background Art

[0002] Pre-filled syringe systems, or PFS systems or devices for short, are well known per se and are used to administer a variety of different therapeutic or drug products or formulations, which are usually prepared as solutions of different viscosities. PFS systems usually include a main syringe body forming a chamber in which the drug to be administered is contained, and an internally movable plunger head, the syringe body forming a chamber in which the drug to be administered is contained, the plunger head being located within the syringe body chamber, and the plunger head being usually controlled by a plunger rod connected to the plunger head and extending out and beyond the proximal open end of the syringe body. The distal end of the syringe body usually includes a shoulder and a neck having a diameter narrower than that of the main syringe body, and a hypodermic needle or cannula, the shoulder and neck having a diameter narrower than that of the main syringe body, the hypodermic needle can be mounted on the neck, and the cannula is inserted into the proximal opening of the syringe body so as to be able to deliver the drug product from the chamber of the syringe body to the patient or subject receiving the injection. As will be appreciated from the foregoing, "proximal" refers to a point towards the body or hand of a user operating the PFS, while "distal" refers to a point away from the body of the user of the PFS. In the case where the user of the PFS and the recipient of the injection are the same, i.e., in the case of self-injection, "proximal" refers to a point in the direction in which the hand operates the PFS to administer the injection, while "distal" refers to a point directed towards the injection site. The syringe body may optionally and usefully include a finger grip device or gripping surface such as a flange at the proximal end of the syringe body to enable the user of the PFS to grasp the syringe body with two fingers of one hand and push the plunger rod in a proximal direction with the thumb, thereby moving the plunger head in a proximal direction to cause the product contained in the main syringe body chamber to be expelled through the needle or cannula. The distally located needle or cannula is typically provided with a removable needle guard or cap, which is typically removed by hand prior to injection to expose the needle and allow the needle to enter the body of the injection recipient, whether that part of the body is skin, muscle or some other body part. At this time, and any time the needle or cannula is exposed, there is a known risk of accidental exposure of the needle or cannula tip, with a corresponding risk of injury, or perhaps worse, improper administration of the product contained within the syringe body chamber.

[0003] Both medically trained and non-medically trained users use PFS systems of the type described above. While medically trained users become accustomed to operating such devices after appropriate training, individual medically untrained users, such as patients themselves, sometimes still have difficulty correctly and / or appropriately using these PFS devices. Manufacturers of such PFS systems have been striving to make such systems as simple and safe to use as possible, and to minimize the risk of accidental injury through the use of such devices. Typically, this is achieved by hiding the PFS in more or less close proximity, and devising methods to reduce actual physical contact with the PFS.

[0004] Despite the above-mentioned advances, difficulties still exist in properly using such PFS systems, at least for many users, even if they are concealed by accessories. For example, some users who need to administer the medication provided in such PFS systems also have general neurological and / or muscle coordination difficulties that make the operation of the PFS systems and related accessories incomplete, inaccurate, or imprecise. Other users are afraid of seeing, handling, or otherwise manipulating the needle, including inserting the needle into the body, and therefore face significant psychological challenges when attempting to use the most common commercial PFS systems, despite relative improvements in user-friendliness. Such challenges can affect the patient's health and, more importantly, the treatment regimen that the device user-patient should follow involving such a pen injection system.

[0005] Therefore, there have been some attempts to overcome the above difficulties by providing an automatic or semi-automatic needle inserter, also called an automatic inserter device. The purpose of such an automatic inserter device (which itself can be considered as a separate device and an accessory to the PFS) is to facilitate the entry of the needle of the PFS into the injection site of the body at the correct angle, and by allowing the user to position the PFS within the automatic inserter, prepare the automatic inserter to prepare the PFS for injection, and then allow the installed injection pen system to be released so that the user does not have to face the situation of having to pierce himself with the needle of the PFS.

[0006] For example, published US patents US5980491A and US6537252B1 both relate to an automatic insertion device for a pen-shaped injector, the device comprising a tubular housing, wherein an injection pen is mounted in a tubular pen holder, the pen holder being movable in a proximal direction along the longitudinal axis of the pen and the automatic needle insertion device, i.e. axially towards the hand and / or body of the user, to compress a spring which is subsequently released to drive the pen holder and the pen to move a set distance in a distal direction. The injection pen is distally connected to a cartridge containing a drug, and a needle is mounted to the distal end of the cartridge containing the drug. The system is dedicated to products manufactured and commercialized by the applicants of these patents.

[0007] Furthermore, the published French patent application FR3079422A1 relates to another automatic inserter device configured to accommodate an injection pen system, such as an insulin injection pen, the automatic inserter device comprising a body having a holder for the injection system, the body being configured to be moved from a standby position to a non-standby position by activation of a control member, thereby enabling the holder to move axially. The automatic inserter body comprises a threaded fastening ring system, which enables the injection pen system to be inserted into the automatic inserter body. The threaded fastening ring system comprises an engagement surface having a proximal truncated cone-shaped inner surface, which gradually engages against a correspondingly shaped truncated cone-shaped outer surface of a hollow deformable portion by the action of the threads of the fastening ring, which in turn compresses a plastic ring, thereby reducing the diameter of the opening from a first wider diameter position, in which the free axial movement of the pen-type injection system is allowed, to a second narrower diameter position, in which the plastic ring is pressed against and retains the body of the pen-type injection system. Summary of the invention

[0008] As used herein, the terms "PFS system or device" and "prefilled syringe system or device" are used interchangeably to refer to a handheld prefilled syringe, typically as described above, such PFS systems are themselves well known and commercially available for the treatment of many different medical indications. These systems are also typically designed to be self-injected by a user who requires treatment for a given medical indication. This is the case, for example, with insulin, which is provided in various forms for the treatment of diabetes. Similar constructed PFS systems may also be used or have been used to treat other physiological and / or pathological conditions using various injectable formulations containing active ingredients, such as adrenaline, epinephrine, methotrexate, recombinant monoclonal antibodies, human growth hormone, hyaluronic acid, and the like.

[0009] It is therefore an aspect of the present invention to provide an automated inserter for a PFS system that is adapted to accommodate and work with various shapes and sizes of pre-filled syringe systems currently in use.

[0010] Another aspect of the present invention is to provide an automatic inserter for a PFS system that is easier, safer and more reliable to use and operate than known solutions.

[0011] Another aspect of the present invention is to provide an automated inserter for a PFS system that minimizes to a large extent the likelihood that a user of the PFS system will incorrectly prepare and administer an injection from the PFS.

[0012] Another aspect of the present invention is to provide an automated inserter for a PFS system that reduces the likelihood of accidental needle stick injuries to the user.

[0013] Another aspect of the present invention is to provide an automatic inserter for a PFS system that reduces the user's fear of visible needles.

[0014] These and other aspects of the present invention will become apparent from a complete reading of this specification.

[0015] Therefore, according to any of the above aspects, there is provided an automatic inserter for a pre-filled syringe system, comprising:

[0016] an elongated inserter body having proximal and distal ends and a longitudinal bore extending through the elongated body from the proximal end to the distal end, the longitudinal bore having a central longitudinal axis, wherein the elongated inserter body is sized and configured to receive a prefilled syringe introduced into the bore through the proximal end of the inserter body and is also configured and sized to prevent the prefilled syringe from exiting the longitudinal bore through the distal end;

[0017] Wherein, the automatic inserter also includes a needle cover holder, which is connected to the distal end of the inserter body by a rotatable hinge, and the needle cover holder is configured to move from a first closed position to a second open position by rotation of the hinge around the rotation axis of the hinge. In the first closed position, before injection, when the prefilled syringe is accommodated in the inserter body, the needle cover holder accommodates the needle cover, which is removably mounted on the injection needle of the prefilled syringe; in the second open position, in preparation for the injection step, the needle cover holder holds the needle cover in a position removed from the prefilled syringe while still being connected to the inserter holder body by the rotatable hinge.

[0018] As mentioned above, the size of the elongated inserter body is designed and configured to accommodate a pre-filled syringe system, which is introduced into the hole of the inserter body through its proximal end. This configuration is based on the following configuration of the opening of the hole at the proximal end of the elongated inserter body, and the size of the opening is designed to be sufficient to allow at least the distal end of the pre-filled syringe to be inserted into the opening and the longitudinal hole. Although the overall shape of the elongated inserter body is cylindrical, it is also possible to set the widening and / or narrowing of the hole of suitable size, shape and configuration along the length of the inserter body.

[0019] In addition, the elongated inserter body is appropriately constructed and dimensioned to prevent the pre-filled syringe from leaving the longitudinal hole through the distal end of the inserter body. This can be achieved in a variety of ways, for example, by providing one or more abutment shoulders protruding inwardly from the inner surface of the elongated inserter body, or other forms of suitable abutments, to prevent the pre-filled syringe from being over-inserted along the axial length of the inserter body or along the components located inside the inserter body in the hole. Particularly advantageous solutions in this regard are provided in more detail in this specification.

[0020] In addition, the automatic inserter also includes a needle cover holder, which is connected to the distal end of the inserter body by a rotatable hinge. For example, the rotatable hinge can be a simple hinge, or an axis or pin and hole structure, similar to those mechanisms usually created on a watchband. The needle cover holder can be moved to an open position from a normal closed position (for example, when the inserter is not in use or in the process of introducing the prefilled syringe into the inserter body), in which the needle cover holder no longer closes the distal opening of the inserter body. The cover holder is moved by rotating the hinge around the axis of rotation. When in the closed position, the needle cover holder accommodates and maintains the needle cover, which is usually attached to the distal end of the needle installed on the prefilled syringe or attached to the distal end of the sleeve inserted in the prefilled syringe. This needle cover is usually used for prefilled syringes to protect users from accidental stabs of needles. Since the needle cover holder holds the needle cover in the closed position, when the needle cover holder is moved to the open position, it temporarily removes the needle cover away from the prefilled syringe, or from the prefilled syringe, while still remaining connected to the inserter holder body by the rotatable hinge. This is in contrast to known specific needle cover removers, which, although configured to receive the needle cover and remove the needle cover prior to injection, are usually separate from the prefilled syringe system, with the disadvantage that the needle cover may be lost, misplaced, or replaced when needed again and / or incorrectly, resulting in a potential injury from an exposed needle after injection.

[0021] According to another aspect, the rotatable hinge has an axis of rotation, which is orthogonal to the central longitudinal axis of the inserter body. In this configuration, the needle cover holder can be rotated away from and away from the inserter body holding the prefilled syringe without interfering with the operation of preparing and implementing an injection.

[0022] Therefore, the hinged needle cover holder is also configured to move from the second position back to the first position after injection is completed, by rotation of the needle cover holder about the rotation axis of the hinge, thereby repositioning the needle cover back onto the injection needle of the prefilled syringe.

[0023] According to one aspect, the hinged needle cover holder includes a resiliently deformable friction clamping surface, which is configured to engage with and clamp the outer surface of the needle cover. For example, advantageously, the friction clamping surface includes an elastomer. The elastomer will be easily selected from a known list of available elastomers to provide enough friction clamping and engagement contact with the outer surface of the needle cover. The clamping surface can be provided by a group of protrusions extending from the surface of the needle cover holder in a generally V-shaped or open cone, the surface of the needle cover holder inwardly facing the distal opening of the hole of the inserter body. In addition, the needle cover holder can also advantageously include a body composed of the same elastomer, which will form a generally disc-shaped or circular shield to cover the inserter body hole opening at the distal end of the inserter body. The V-shaped or inverted tapered set of projections are configured to surround and frictionally engage the outer surface of the needle cover, which is also typically tapered, whereby the tapered top of the needle cover will be received and surrounded by the corresponding tapered or V-shaped projections of the needle cover holder.

[0024] According to another aspect, the inserter body comprises at least one internal protruding member located within the hole of the inserter body. The internal protruding member may be suitably arranged at a distal position within the hole of the inserter body and may, for example, protrude from a sidewall of the hole into the hole, for example, substantially orthogonal to the longitudinal axis of the inserter body. The internal protruding member is sized and configured to provide another engagement surface with which the needle cover holder may engage, to ensure that, for example, when the cover holder is in a first closed position, the cover is held against the hole opening.

[0025] Thus, according to another aspect, in the first closed position, the hinged needle cover holder comprises an elastically deformable friction clamping member, which is configured to elastically deform around the internal protruding member located in the hole of the inserter body and releasably engage with the internal protruding member. It should be understood that in the second position, the friction clamping part of the needle cover holder does not have any engagement contact with the internal protruding member. Therefore, if needed and / or necessary, such internal protruding member is also free to move accordingly, or remains in its original position. As will be described below, it is advantageous that the internal protruding member can be appropriately attached to the movable member located in the hole of the inserter body, or extend from the movable member. In this configuration, the internal protruding member is therefore only available for the friction clamping member of the needle cover holder at certain specific positions of the movable member when such an internal protruding member is provided on the movable member.

[0026] According to a further aspect, the resiliently deformable friction gripping member is formed as an extension of the body of the hinged needle cover holder and the extension projects into the aperture of the inserter body when the needle cover holder is in the first closed position.

[0027] As described above, the hinged needle cover holder in the first position completely covers the distal opening of the inserter body hole, and correspondingly, when the hinged needle cover holder is in the second position, the distal opening of the inserter body hole is not blocked by the needle cover holder and is fully opened to prepare and perform an injection operation.

[0028] According to another aspect, there is provided an automatic inserter for a prefilled syringe system, comprising:

[0029] an elongated inserter body having proximal and distal ends and a longitudinal bore extending through the elongated body from the proximal end to the distal end, the longitudinal bore having a central longitudinal axis, wherein the elongated inserter body is sized and configured to receive a prefilled syringe introduced into the bore through the proximal end of the inserter body and is further configured and sized to prevent the prefilled syringe from exiting the longitudinal bore through the distal end;

[0030] wherein the inserter body includes a slidable syringe body support assembly positioned within the bore, the support assembly being configured to receive and at least partially surround the syringe body,

[0031] The slidable support assembly includes a translation system, which is configured to translate the slidable support assembly and the syringe body accommodated in the slidable support assembly from at least a first axial position to at least a second axial position along the central longitudinal axis of the inserter body hole, and the second axial position is axially away from the first position.

[0032] According to this aspect, the inserter body is provided with a slidable syringe body support assembly. The slidable support assembly is designed and configured to at least partially surround the syringe body, but is also adapted to move the syringe body within and along the longitudinal axis of the hole of the inserter body, so that the syringe body of the pre-filled syringe can be easily positioned at a plurality of key positions consistent with the desired and expected functions of the automatic inserter. Therefore, the slidable support assembly includes a translation system, which is configured to translate the slidable support assembly and the syringe body contained in the slidable support assembly from at least a first axial position to at least a second axial position along the central longitudinal axis of the inserter body hole, and the second axial position is axially away from the first position. For example, there will be at least two main positions, and it is necessary to be able to move the slidable support assembly of the syringe body holding the pre-filled syringe to these two main positions. For example, the first such position will be a standby position, in which the pre-filled syringe will be placed in a position within the hole of the inserter body so that it can be accelerated by a properly organized translation mechanism (e.g., a spring biased ratchet). A second such position may be an injection ready position, e.g., a position to which the prefilled syringe has been moved, properly speaking, in preparation for an injection step, i.e., a step of operating the plunger of the prefilled syringe to expel the product from the chamber and into any part of the body that is the intended target area for administration. Other suitable or advantageous positions of the slidable support assembly are possible and will be discussed in further detail herein.

[0033] According to another aspect, the slidable syringe body support assembly comprises a first axially movable cylinder coaxially located in the inserter hole, and a second axially movable cylinder coaxially located in the inserter hole, the second axially movable cylinder preferably coaxially located in the hole of the first movable cylinder. Thus, the first and second axially movable cylinders are capable of and configured to move axially along the central longitudinal axis of the inserter body, one within the other, in which case the second cylinder is preferably within the first cylinder. In addition, both the first and second cylinders are configured to be movable within the hole of the inserter body.

[0034] According to yet another aspect, the first axially movable cylinder and the second axially movable cylinder are configured to move axially independently of each other within the inserter body bore. According to another aspect and as described above, the first axially movable cylinder and the second axially movable cylinder are configured to move axially together within the inserter body bore. The reason for this desired axial freedom of movement of the first and second movable cylinders will become apparent upon further reading of this specification.

[0035] According to another aspect, and as described above, as desired and advantageous, at least the first axial position is a standby position, in which the prefilled syringe is moved in the proximal direction to prepare the prefilled syringe for subsequent axial acceleration in the proximal direction before the injection step. The standby position is a position in which the automatic inserter pre-positions the prefilled syringe and the needle attached to the prefilled syringe, and moves quickly or accelerates from the standby position to an axially distant position closer to a predetermined target or injection administration site. The inserter is called an automatic inserter because the step is equivalent to, for example, pulling a trigger on a firearm, and generally involves some kind of stored energy or braking, such as using a biasing element such as a coil spring. When the stored energy (e.g., a spring) is released, generally by activating a trigger mechanism, the released energy points to the direction in which the prefilled syringe and the needle should be accelerated so that the needle can penetrate the administration site, whether it is skin, muscle or some other target. Naturally, the purpose of the automatic inserter is to provide only enough directed energy to provide such a penetration depth, without pushing the needle too deep, which would cause pain and make the user likely to avoid using the device again in subsequent injections. Such energy storage and directing mechanisms are within the capabilities of the skilled person to provide and design, and are themselves well known in the art, for example in injection pen systems commercially available for the treatment of diabetes and other diseases. Such mechanisms may be useful in the present context of this automatic inserter.

[0036] According to another object of the present invention, as described above, at least the second axial position is an injection-ready position in which at least the distal portion of the prefilled syringe extends beyond the distal end of the inserter body. The length of the distal portion of the prefilled syringe, in particular the length of the needle extending beyond the end of the inserter body, is designed to avoid excessive trauma to the user and minimize any associated pain caused by the depth of penetration of the needle at the administration site. It should be noted here that the term "injection-ready" in the current context only means that the prefilled syringe is in a suitable position in which an injection of the product contained in the syringe chamber can be implemented, rather than indicating that the injection has actually been performed or activated. The user still has to depress the syringe plunger to expel the product from the chamber to the administration position. This is performed as a subsequent operation of moving the slidable support assembly and the prefilled syringe inserted into the slidable support assembly to the injection-ready position.

[0037] According to yet another aspect, the inserter body comprises a syringe plunger locking plate. The locking plate serves several purposes, one of which is to lock the plunger, preventing any axial movement of the plunger relative to the locking plate, but not preventing axial movement of the locking plate and the plunger together in the axial direction.

[0038] Thus, on the other hand, the syringe plunger locking plate is constructed and adapted to move from an unlocked position, wherein the locking plate is disengaged from the syringe plunger, to a locked position, wherein the locking plate engages the syringe plunger and prevents axial movement of the syringe plunger relative to the locking plate.

[0039] Thus, according to one aspect, the locking plate is configured to engage with the proximal end of the syringe body. The locking plate may advantageously be shaped to support, surround and engage against the proximal end of the syringe body, such as a finger flange.

[0040] According to another aspect, the locking plate can also be configured, for example and advantageously, to move orthogonally to the proximal end of the syringe plunger and the syringe body when moving from the first unlocked position to the second locked position. In this configuration, when in the first position, the locking plate is disengaged from the syringe plunger and disengaged from the proximal end of the syringe body. It can move from the first unlocked position, for example by sliding the plate orthogonal to the central longitudinal axis, along a set of parallel tracks or grooves arranged transversely to the length of the hole, on the inwardly facing wall of the inserter body, toward the proximal end of the syringe body. The locking plate can advantageously be provided with a flange groove extending, for example, in a distal direction, which, when reaching the second locked position, moves around the finger-shaped flange at the proximal end of the syringe body and supports and engages the finger-shaped flange. In the first unlocked position, the locking plate can advantageously present a first end extending outside the inserter body, while in the locked position, the first end is completely contained in the hole of the inserter body. This has the advantage of clearly indicating to the user whether the locking plate is engaged in the first position or the second position and, moreover, makes it easy to move the locking plate simply by pushing or pulling, respectively, the first end of the locking plate to move the locking plate into or out of the locking position. Moreover, only in the locking position is the plate free to move within the aperture of the inserter body.

[0041] Therefore, according to one aspect, the slidable syringe body support assembly including the first axially movable barrel and the second axially movable barrel is moved together with the locking plate simultaneously in the proximal direction to the first standby position. Therefore, moving the support assembly to the standby position also moves the locking plate simultaneously.

[0042] According to another aspect, the slidable support assembly is moved to the first standby position such that the needle cover at the distal end of the prefilled syringe is retained in the needle cover holder. As described above, the needle cover is retained by the frictional engagement of the needle cover holder with the needle cover. The frictional engagement is configured such that the resistance to separation from the needle cover holder is greater than the corresponding resistance to separation between the needle cover and the shoulder of the syringe body, such that when the syringe body moves with the slidable support to the standby position, i.e., in a proximal direction away from the needle cover holder and the distal end of the inserter body, the needle cover is retained by the cover holder and separated from the shoulder of the syringe body.

[0043] Thus, when the first axially movable cylinder, the second axially movable cylinder and the locking plate are in the first armed position, the needle cover holder can then be moved from the first closed position to the second open position because the now exposed needle has been moved in the proximal direction away from any potential contact with the user's hand, thereby avoiding accidental needle stick injuries.

[0044] According to yet another aspect, the slidable syringe body support assembly including the first axially movable cylinder and the second axially movable cylinder is configured to move together with the locking plate in the distal direction to the second injection ready position simultaneously. This occurs when the trigger of the accumulated energy is activated. The trigger and the accumulated energy form part of the translation mechanism of the automatic inserter and use solutions commonly known to those skilled in the art, such as biasing springs, etc., to bias the movable cylinder and the locking plate to the injection ready position.

[0045] According to another aspect, the second axially movable cylinder of the slidable syringe body support assembly is configured to move in the proximal direction to a third syringe retracted position together with the locking plate. The third syringe retracted position preferably only involves the second axially movable cylinder and the locking plate and corresponds to an axial position along the longitudinal axis of the inserter hole in which the needle no longer extends beyond the distal open end of the inserter hole. In this configuration, if the syringe is thrown away with the inserter body, the third position can be the final position to which the syringe will be moved, but since the purpose is to reuse the automatic inserter, the third position is only an intermediate position, the purpose of which is to protect the inserter and the user from potential accidents caused by the needle being exposed after the injection is completed. In this position, the needle of the syringe is completely contained in the hole of the inserter.

[0046] Therefore, according to another aspect, in the syringe retracted position, the needle cover holder can be moved from the second open position to the first closed position. Doing so will correspondingly move the needle cover back into place to replace or reinstall on the distal end of the needle.

[0047] According to yet another aspect, the second axially movable cylinder of the slidable syringe body support assembly is configured to move in a distal direction with the locking plate to a fourth syringe release position. The syringe release position moves the movable cylinder back to a position allowing the now empty or exhausted syringe to be removed from the inserter hole. In addition, the locking plate can slide back to the first unlocked position, in which the first end of the plate extends beyond the inserter body wall and further prevents any proximal movement of the cylinder.

[0048] As described above, with respect to the locking plate, and according to another aspect, the locking plate includes a locking device configured to releasably engage the proximal end of the second axially movable barrel of the slidable support assembly. Such a locking device can be, for example, a groove flange disposed on the locking plate, the groove flange being shaped to receive, support and engage at least a portion of the finger flange of the syringe body at its proximal end.

[0049] In addition, according to yet another aspect, the locking plate includes a plunger rod support collar extending from the locking plate in a proximal direction to slidably contact at least a portion of the plunger rod, the support collar being configured to move from a depressed state to an expanded state, or from an expanded state to a depressed state. The support collar serves several purposes, for example, providing a contact surface for the proximal end of the plunger when an injection is made. When the proximal end of the plunger contacts the proximally facing contact surface of the support collar, it prevents excessive force from being applied to the movable cylinder.

[0050] These and other objects of the present invention will become apparent and described in more detail in the following description in connection with the accompanying drawings and example monitoring modules. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] The present invention will now be described in more detail with reference to the accompanying drawings, which are provided for the purpose of illustration and example, in which:

[0052] Figure 1 is a schematic side view of an automatic inserter device according to the present invention, wherein a prefilled syringe has been introduced into the inserter;

[0053] Figure 2 yes Figure 1 A schematic cross-sectional view of an inserter;

[0054] Figure 3 yes Figure 1 and Figure 2 Another schematic cross-sectional view of the inserter rotated about 90°;

[0055] Figure 4 It is along Figure 1A schematic top view of the inserter viewed along a central longitudinal axis;

[0056] Figure 5 yes Figure 1 A schematic perspective view of an inserter device;

[0057] Fig. 6A and 6B is a schematic cross-sectional view of a configuration of a first relative position of some components of an inserter device;

[0058] Fig. 7A and 7B is a schematic, partial, enlarged view of some details of components of the inserter device;

[0059] Figure 8 yes Figure 1 An exploded perspective view of an inserter device of , with any introduced pre-filled syringe removed;

[0060] Fig. 9 is a partial enlarged view of another detail of the inserter device;

[0061] Fig. 10A and 10B yes Figure 1 Schematic perspective view of an inserter showing the relative positions of the prefilled syringe and other components of the inserter;

[0062] Fig.11A and 11B Yes Fig. 10A and 10B A schematic cross-sectional view of the inserter shown;

[0063] Fig.12 is a partial enlarged view of another detail of the inserter device;

[0064] Fig.13 is a partial enlarged view of another detail of the inserter device;

[0065] Fig.14A and 14B is a schematic cross-sectional view of some relative positions of components of an inserter device;

[0066] Fig.15 is a schematic cross-sectional view of an inserter device in a position ready for injection;

[0067] Fig.16 yes Fig.15 A schematic cross-sectional view of an inserter device shown in an injection ready position and rotated approximately 90 degrees;

[0068] Fig.17 is a partial enlarged view of the inserter device details;

[0069] Fig.18 is a schematic cross-sectional view of the relative position of a syringe in a retracted position within an inserter;

[0070] Fig.19 is another schematic cross-sectional view of the relative position of the syringe in the retracted position within the inserter, showing further details;

[0071] Fig. 20 is a schematic cross-sectional view of the relative position of a syringe in another position within an inserter;

[0072] Fig.21 is a schematic cross-sectional view of the relative position of the syringe after withdrawal from the inserter after use. DETAILED DESCRIPTION

[0073] Now turning to the attached figure, Figure 1 and Figure 2 Schematically showing a side view of an automatic inserter device (1) according to the present invention ( Figure 1 ) and a cross-sectional view along the axis A-A' ( Figure 2 ), that is, from Figure 1 The inserter is viewed from the left hand side of the device, wherein a prefilled syringe (2) has been introduced into the inserter. As used herein, the term prefilled syringe (2), or "PFS system or device", or simply "PFS", refers to a prefilled syringe which is usually hand-held. Such PFS systems are well known per se and are commercially available for the treatment of many different medical indications. The PFS system usually comprises a main syringe body (3) which forms a chamber (4), see Figure 2, a chamber (4) containing a drug product to be administered, and a plunger head (5) located within the chamber (4) of the syringe body and movable internally, the plunger head (5) being generally controlled by a plunger rod (6) connected to the plunger head (5) and extending out and beyond a proximal end (7) of the syringe body (3), the proximal end (7) having an opening (8). The distal end (9) of the syringe body (3) generally includes a shoulder (10) and a neck (11) and a distal opening (12), the shoulder (10) and the neck (11) being narrower in diameter than the main syringe body (3), wherein a hypodermic needle (13) having an open distal end (14) can be mounted on the neck (11), for example, by a needle mounting connector that engages with the neck (11) and the shoulder (10) in a known manner (e.g., by threads), or a cannula inserted into the distal opening (12) to enable the drug product to be delivered from the chamber (4) of the syringe body (3) to the patient or subject receiving the injection. As will be understood from the foregoing, "proximal" refers to a point generally pointing toward the body or hand of a user operating the PFS, whereas "distal" refers to a point away from the body of the user of the PFS. In the case where the user of the PFS and the recipient of the injection are the same, i.e. in the case of self-injection, "proximal" refers to a point in the direction in which the hand operates the PFS to administer the injection, whereas "distal" refers to a point pointing toward the injection site. The syringe body (3) may optionally and usefully include a finger grip device or gripping surface, such as a flange (15), located at the proximal end (7) of the syringe body (3) to enable the user of the PFS to grasp the syringe body (3) with two fingers of one hand and push the plunger head (5) with the thumb in the proximal direction, thereby moving the plunger rod (6) in the distal direction, so that the product contained in the main syringe body chamber (3) is discharged through the distal opening (14) of the needle (13) or cannula. The distally located needle (13) or cannula is typically provided with a removable needle guard (16) or cover which is typically removed by hand prior to injection to expose the needle (13) and allow the needle to enter the body of the injection recipient, whether that part of the body is skin, muscle or some other body part. At this point, and any time the needle (13) or cannula is exposed, there is a known risk of accidental exposure of the needle (13) or cannula tip, thereby risking injury or, perhaps worse, improper administration of the product contained within the syringe body chamber (3).

[0074] The automatic inserter device (1) as shown in the figure comprises an elongated inserter body (17) having a proximal end (18) and a distal end (19), and a longitudinal bore (20) extending through the elongated body (17) from the proximal end (18) to the distal end (19), the longitudinal bore (20) having a central longitudinal axis (21), wherein the elongated inserter body (17) is sized and configured to accommodate a prefilled syringe (2) introduced into the bore (20) along the central longitudinal axis (21) through the proximal end (18) of the inserter body (17). This configuration presupposes an opening (22) of the bore (20) at the proximal end (18) of the elongated inserter body (17) that is sized to allow at least the distal end (9) of the prefilled syringe (2) to be inserted into the opening and the longitudinal bore (20). Although the overall shape of the elongated inserter body (17) is cylindrical, Figure 1 and 2 As can be seen in the figure, the body also includes a widening portion (23) and / or a narrowing portion (24) of the hole along the length of the inserter body (17). As will be described herein, the narrowing portion (24) can be, for example, suitably formed as one or more abutment shoulders (24a, 24b, 24c, etc.) protruding inwardly from the inner surface (25) of the elongated inserter body, or other forms of suitable abutments to prevent over-insertion of the prefilled syringe along the axial length of the inserter body or other internal positioning components located within the hole.

[0075] The automatic inserter device (1) also includes actuatable positioning means, locking means and stabilizing means to maintain the PFS (2) in a series of predetermined axial and lateral positions according to a sequential operation, thereby limiting the relative axial movement of the PFS within the inserter device (1) and, additionally, preventing it from exiting the longitudinal hole (20) through the distal end (19) of the inserter body (17). Details of these actuatable positioning means, locking means and stabilizing means will be provided below, but as Figure 1 and Figure 2 As shown, the PFS (2) is held in a first locked axial and lateral position, wherein the lateral position locking means refers to means for preventing the PFS from moving or being moved laterally away from and out of alignment with the central longitudinal axis (21). Figure 1As shown, the elongated body (17) of the automatic inserter device is provided with a first gripping member (26) and a second gripping member (27), the second gripping member (27) being spaced apart from the first gripping member (26) along the longitudinal axis (21) of the inserter body (17), and the first gripping member (26) and the second gripping member (27) being located on the outward surface (28) of the inserter body (17), or protruding outwardly from the outward surface (28) of the inserter body (17). The first gripping member (26) and the second gripping member (27) are respectively shaped and configured to facilitate the user to grip the inserter device (1). The distance between the first gripping member (26) and the second gripping member (27) is configured to allow one or more fingers to comfortably rest on the outward surface (29) of the first gripping member (26) and / or the second gripping member (27) during use of the inserter device (1). In addition to the first and second gripping members (26, 27), a grip enhancement area or area (30) is located on the outward surface (28) of the inserter body (17), for example at 90° or 180° relative to the gripping members (26, 27) about the longitudinal axis (21). The grip enhancement area (30) can be suitably provided by a series of appropriately shaped ridges (31) and grooves (32) formed from a soft molded elastomeric material, which is known per se. Figure 1 As can also be seen in the drawings, the elongated inserter body (17) has at least one or more cut-out portions (33a, 33b) defining openings (34a, 34b) in the elongated inserter body (17), the cut-out portions being located adjacent or proximal to the proximal end (18) of the elongated inserter body (17). The cut-out portions or openings (33a, 33b, 34a, 34b) allow a user to see and / or access certain components of the inserter device and / or PFS (2) located within the bore (20), and also provide the user with access to and visibility of a locking mechanism for locking the PFS (2) in a predetermined initial axial position within the longitudinal bore (20) of the inserter body (17), as will be described in more detail below.

[0076] The automatic inserter device (1) further comprises a needle cover holder (35) connected to the distal end (19) of the inserter body (17) by a rotatable hinge (36). The needle cover holder (35) is configured to move from a first closed position, in which the needle cover holder (35) holds a needle cover or needle guard (16) removably mounted on the injection needle (14) of the PFS (2) when the injection needle (14) of the PFS (2) is accommodated in the inserter body (17) before injection, to a second open position, in which the needle cover holder (35) holds the needle cover (16) in a position removed from the PFS (2) while still being connected to the inserter holder body (17) by the rotatable hinge (36), by rotation of the hinge (36) about a rotation axis (37) of the hinge (36). For example, the rotatable hinge (36) may be a simple hinge, or an axle or pin and hole mechanism, similar to those commonly provided on watch bands, for example. Thus, the needle cover holder (35) can be moved from a normal closed position (e.g. when the inserter device (1) is not in use, or during the introduction of the PFS (2) into the inserter body (17)) to an open position in which the needle cover holder (35) no longer closes the distal end (19) opening (19a) of the inserter body (17). The cover holder (35) is moved by rotating the hinge (36) around the axis of rotation (37) of the hinge (36). When in the closed position, the needle cover holder (35) accommodates and holds a needle cover (16) attached to the distal end (14) of the needle (13) mounted on the prefilled syringe (2) or the needle cover (16) attached to the cannula inserted into the prefilled syringe (2). Such a needle cover (16) is typically used with pre-filled syringes to protect the user from accidental needle sticks. Since the needle cover holder (35) holds the needle cover (16) in a first closed position, when the needle cover holder (35) is moved to a second open position, it temporarily removes the needle cover (16) to a position away from the pre-filled syringe (2), or is removed from the pre-filled syringe (2), while still remaining connected to the inserter holder body (17) via a rotatable hinge (36). This is in contrast to known needle cover removers, which, although they are configured to accommodate the needle cover and remove the needle cover prior to injection, are typically separate from the pre-filled syringe system, which has the disadvantage that the needle cover may be lost, misplaced, or incorrectly replaced when needed again, resulting in a potential injury from an exposed needle after injection.

[0077] As can be clearly seen from the figure, the rotatable hinge (36) has an axis of rotation (37) which is orthogonal to the central longitudinal axis (21) of the inserter body (17). In this configuration, the needle cover holder (35) can be rotated away from and away from the inserter body (17) holding the pre-filled syringe (2) without interfering with the operation of preparing and implementing the injection. Therefore, after the injection is completed, the hinged needle cover holder (35) can be moved back from the second open position to the first closed position by rotating the cover holder (35) about the axis of rotation (36) of the hinge (37), thereby repositioning the needle cover (16) back onto the distal opening (14) of the injection needle (13) of the pre-filled syringe (2).

[0078] The hinged needle cover holder (35) also advantageously includes an elastically deformable friction clamping surface (38) configured to engage and clamp the outer surface (39) of the needle cover (16). For example, the friction clamping surface (38) includes an elastomer. The elastomer will be easily selected from a list of known available elastomers to provide sufficient friction clamping and engagement contact with the outer surface (39) of the needle cover (16). The friction clamping surface (38) can be provided by a set of protrusions (40) of a generally V-shaped or open cone shape, the protrusions (40) extending from the inward surface (41) of the needle cover holder (35) toward the distal opening (19a) of the hole (20) of the inserter body (17). The needle cover holder (35) advantageously also includes a body (42) constructed of the same elastomer as the friction gripping surface (38), which will form a generally disc-shaped or circular shield to cover the inserter body bore opening (19a) located at the distal end (19) of the inserter body (17). A set of V-shaped or inverted conical protrusions (40) are configured to surround and frictionally engage the outer surface (39) of the needle cover (16), which is also generally conical, whereby the conical top of the needle cover (16) will be received and surrounded by the corresponding conical or V-shaped protrusions (40) of the needle cover holder (35).

[0079] The inserter body includes at least one internal protruding member (43) located within the aperture (20) of the inserter body (17). As will be described in more detail herein, the internal protruding member (43) can be appropriately disposed at a distal position within the aperture (20) of the inserter body (17) and can, for example, protrude into the aperture (20) from a side wall of the aperture (20) generally orthogonal to the longitudinal axis of the inserter body (17), or protrude into the aperture (20) from another component located within the aperture (20). The internal protruding member (43) is sized and configured to have an engagement surface (44) with which the needle cover retainer (35) can engage to ensure that the cover retainer (35) is retained against the aperture opening (19a), for example when the cover retainer (35) is in a first closed position. In the first closed position of the needle cover retainer 35, as shown in FIG. Figure 2 As shown, the protruding member 43 engages with an elastically deformable friction clamping member 45, which is configured to elastically deform around the internal protruding member 43 located in the hole 20 of the inserter body 17 and releasably engage with the internal protruding member 43. It should be understood that in the second open position, the friction clamping member 45 of the needle cover holder 35 does not have any engagement contact with the internal protruding member 43. Therefore, if necessary and / or necessary, such internal protruding member (43) is also free to move accordingly, or remain in its original position. The internal protruding member (43) is advantageously attached to or extends from a movable member (46), which is coaxially located in the hole of the inserter body (17). In this configuration, the movable member (46) is provided with such an internal protruding member (43), so that the internal protruding member (43) will only be available for the friction clamping member (45) of the needle cover holder (35) at certain specific positions of the movable member (46). Figure 2 The external appearance of such a protruding member (43) is shown, wherein the protruding member (43) is an orthogonal cylinder extending outwardly from the distal end (47) of an axially movable syringe body (3) retainer (46) which is coaxially located within the bore (20) of the elongated inserter body (17). Figure 2It can also be seen in the figure that the elastically deformable friction gripping member (45) is formed as an extension (48) of the main body (42) of the hinged needle cover holder (35), and when the needle cover holder (35) is in the first closed position, the friction gripping member extension (48) extends parallel to the central longitudinal axis into the hole (20) of the inserter body (17). The extension (48) carries at least one pair of elastically deformable arms (49a, 49b) at the proximal end of the extension (48), which further extend from the friction gripping member extension (48) in the proximal direction, and each pair of arms (49a, 49b) engages with a corresponding side surface (44a, 44b) of the orthogonally positioned protruding member (43). As described above, in the first position, the hinged needle cover holder (35) completely covers the distal opening (19a) of the inserter body hole (20), and correspondingly, when the hinged needle cover holder (35) is in the second position, the distal opening (19a) of the inserter body hole is not obstructed by the cover holder (35) and is fully opened to prepare and perform the injection operation.

[0080] In addition, from Figure 2 As can be seen in the figure, the automatic inserter device 1 also includes a slidable syringe body support assembly 50, which is coaxially positioned about the central longitudinal axis 21 and is located within the hole 20 of the elongated inserter body 17. The slidable syringe body support assembly (50) is configured to accommodate and at least partially surround the syringe body through the syringe body holder (46). The slidable support assembly (50) includes a translation system, which is configured to translate the slidable support assembly (50) and the syringe body (3) accommodated therein from at least a first axial position to at least a second axial position along the central longitudinal axis (21) of the inserter body hole (20), the second axial position axially away from the first position.

[0081] A slidable support assembly (50) is designed and constructed to at least partially surround the syringe body (3), but is also adapted to move the syringe body (3) within the aperture (20) of the inserter body (17) and along the longitudinal axis (21) of the aperture so that the syringe body (3) of the prefilled syringe (2) can be easily positioned at a plurality of key positions consistent with the desired and intended function of the automatic inserter device (1). For example, there are at least two primary positions to which the slidable support assembly (50) holding the syringe body (3) of the prefilled syringe needs to be able to be moved. The first such position is a standby position, for example, wherein the prefilled syringe (2) is located within the aperture (20) of the inserter body (17) such that it can be accelerated by a suitably organized translation mechanism, such as a spring-biased pawl. The second such position is an injection ready position, e.g., the pre-filled syringe (2) has been moved to this position, properly speaking, in preparation for the injection step, i.e., in which the plunger of the pre-filled syringe is operated to expel the product from the chamber (4) and into any part of the body that is the intended target area for administration. Other suitable or advantageous positions of the slidable support assembly are also possible and will be discussed in further detail herein.

[0082] The slidable syringe body support assembly (50) includes a first axially movable cylinder (51) and a second axially movable cylinder (46), wherein the first axially movable cylinder (51) is Figure 2 The outer slide body (51) is shown in FIG. 1 and is coaxially located in the inserter hole (20), and the second axially movable cylinder (46) is located in Figure 2 1 and 2. The inner slide body (46) or syringe holder body (46) is shown as the inner slide body (46) and is coaxially located in the inserter bore (20), and the second axially movable cylinder (46) is also coaxially located in the bore of the outer slide body (51). The outer slide body and the inner slide body (51, 46) are axially movable along the central longitudinal axis (21) of the inserter body (17), the latter within the former, and can be moved together or independently of each other as required to move one or the other of the two axially movable cylinders to one or more positions related to the use of the inserter device (1).

[0083] A first axially movable cylinder or outer slide body (51) extends from a proximal end (52) located in a proximal region of the hole (20) to a distal end (53) and has a proximal opening (54) and a distal opening (55) forming a longitudinal hole (56). Near the distal end (53), the outer slide body has a first radially outwardly extending shoulder (57). Near the proximal end (52), the outer slide body (51) also has an elastically deformable arm (58) extending radially outward from the cylinder body and terminating in a proximal hook (59), the function of which will be further described herein. Between the radially outwardly extending shoulder (57) and the elastically deformable arm (58), a biasing spring (60) is located around the outward surface (61) of the outer slide body (51), and the biasing spring (60) engages with the radially outwardly extending shoulder (57) at the distal end (62) of the spring (60). Located proximal to the radially outwardly extending shoulder (57), the outer slider body (51) is provided with a lever arm safety lock (63), the function of which will be further described herein. The lever arm safety lock (63) has a pivoting lock arm (64) having a proximal arm member (64a) and a distal arm member (64b), the proximal and distal arm members (64a, 64b) extending from a fulcrum pivot point (65) mounted on a hinge rod (66), the hinge rod (66) forming a rotation axis similar to an elbow, about which the arm (64) is pivoted from a first unlocked position to a second locked position under the urging of a biasing spring (67), and conversely, from the second locked position to the first unlocked position under the urging of a contact socket (68) extending axially from the needle cover holder (35) into the hole (56). When the needle cover holder is in the first closed position and the outer cylinder is in the rest position, the contact socket (68) is in contact with a shoulder (69) which extends generally orthogonally from the distal end (70) of the distal arm (64b) relative to the longitudinal axis (21). The proximally directed force of the socket (68) against the shoulder (69) is transmitted to the distal arm locking member (64b), causing the arm as a whole (64) to pivot about the fulcrum (65), thereby forcing the proximal arm locking member to be biased against the biasing spring (67). This is therefore the unlocked position of the lever arm safety lock. The biasing strength of the biasing spring (67) is selected not to be so strong as to overcome the lever force applied around the fulcrum due to the contact between the socket (68) and the shoulder (69). However, as will be further described herein, once the contact between the hub (68) and the shoulder (69) is removed, for example, when the needle cover retainer is removed, the biasing spring (67) no longer encounters any resistance and will tend to bias the proximal arm locking member (64b) toward the center of the aperture (56) and toward the first locked position.The outer slide body (51) also has at least one radially inwardly projecting shoulder (71) located proximal to the lever arm safety lock and against which another biasing spring (72) is positioned at the distal end (73) of the spring (72). As will be further described herein, the inner biasing spring (72) of the outer slide is also in compression or biasing contact with the inner slide or syringe holder body (46). Finally, the outer slide body (51) extends in the distal direction from the outer edge (74) of the radially outwardly extending shoulder (57) to the distal end (53), which is in abutting contact with the distal end surface (75) of the inserter body (17) to prevent the outer cylinder (51) from moving beyond the distal end (19) of the inserter body (17).

[0084] like Figure 2 and Figure 3 As shown, Figure 3 express Figure 1 A cross-sectional view of Figure 1 At the front of the automatic inserter device, the inner slide body or syringe body holder (46) is coaxially located within the outer slide body (51). The inner slide body (46) is a generally tubular cylindrical body (76) extending from a proximal end (77) to a distal end (78) and defining a central longitudinal bore (79) having an inwardly facing surface (80). The inwardly facing surface (80) is shaped and sized to receive and engage a corresponding outwardly facing surface of the syringe body (3). Figure 2As shown, the movement of the inner slidable body (46) in the distal direction is limited by the internal biasing spring (72) of the outer slidable body (51), and the inner slidable body (46) is located on the internal biasing spring (72) in the initial rest position. The inner slidable body (46) is provided with a shoulder (82) extending radially outward and a peripheral annular wall (83) extending from the outer edge (84) of the shoulder (82) in the proximal direction. The peripheral annular wall (83) and the tubular cylindrical body (76) define an annular space (85), which extends from the proximal end (77) of the inner slider body (46) parallel to the longitudinal axis to the shoulder (82) extending radially outward. A sliding caliper (86) having a first leg (87a) and a diametrically opposed second leg (87b) is housed in the annular space (85), each caliper leg being provided with an outwardly facing, longitudinally oriented recess (88a, 88b) extending along the length of the leg (87a, 87b), each recess housing a respective biasing spring (89a, 89b). The biasing springs (89a, 89b) are located on a proximally facing surface 90 of the radially outwardly extending shoulder 82. The first caliper leg (87a) and the second caliper leg (87b) are connected at respective proximal ends (91a, 91b) of the respective legs (87a, 87b) to a cylindrical caliper body (92) sized to slide along the longitudinal axis (21) within the annular space (85). The legs (87a, 87b) of the caliper (86) extend in the distal direction from the proximal ends (90a, 90b) through a pair of corresponding openings (93a, 93b) provided in the radially outwardly extending shoulder of the inner slide (46) and into the bore (56) of the outer slide (51), thus being parallel to and outside the tubular body (76) of the inner slide (46). Thus, the biasing springs (89a, 89b) are located at the bottom of the annular space (85), between the corresponding openings (93a, 93b) of the radially extending shoulder (82) and the peripheral annular wall (86), and are received in the corresponding grooves (88a, 88b) of the legs (87a, 87b) of the caliper. The biasing spring (88a, 88b) is also engaged with and constrained or compressed by a distally facing surface (94) of a proximally radially inwardly extending shoulder (95) extending radially inwardly from the cylindrical caliper body (92) into the inserter body bore (20). The cylindrical caliper body (92) is also provided with a pair of radially opposed outwardly projecting beams (97a, 97b) at the proximal end (96) of the caliper body. The pair of beams are shaped and configured to receive a plunger rod support collar (99) and serve as an axis of rotation (98) for the plunger rod support collar (99).The support collar (99) is rotatably or pivotally mounted at its distal end (100) to the caliper body (92) by beams (97a, 97b) extending through a respective pair of support collar legs (100a, 100b) and providing respective rotation axes (98) for the support collar legs (100a, 100b), the support collar legs having transverse openings (101a, 101b) at the distal end (102a, 102b) of each leg (100a, 100b). Each support collar leg (100a, 100b) extends from the distal end (102a, 102b) in a proximal direction toward a proximal transverse bar (103) that connects the legs (100a, 100b) together at a proximal end (104) of the support collar (99). The transverse rod (103) is generally provided with a curved or arcuate bracket (105) centered about the hole (20) at its central portion, and the bracket (105) is shaped and dimensioned to engage against and support or lightly support the outer surface of the plunger rod (6) when the PFS (2) is introduced into the automatic inserter device (1) and during operation of the automatic inserter device (1). The arcuate bracket (105) of the support collar (99) is shaped to allow the plunger rod (6) to slide axially in the bracket (105) in the distal and proximal directions, depending on the relative movement imparted by other movable components of the automatic inserter device (1), as will be described in more detail herein. The support collar (99) is also configured to move from a depressed state, in which the collar is located in a plane orthogonal to the central longitudinal axis (21) and is generally in a horizontal position, to an expanded state, in which the support collar is generally in a vertical position, aligned parallel to the central longitudinal axis, and vice versa, so as to be able to return to the depressed state. The support collar (99) serves several purposes, for example, to provide a proximal contact surface (106) for the proximal end (107) of the plunger rod (6) when an injection is performed. During distal axial movement of the inner and outer slides (46, 51), for example during an injection, the contact between the proximal end (107) of the plunger rod (6) and the proximally facing contact surface (106) of the support collar (99) prevents excessive force from being applied to the inner and outer slidable cylinders (46, 51), thereby reducing the risk of damaging the overall integrity of the inserter device. It can be understood from the foregoing that the support collar (99) is connected to the caliper (92), and the caliper (92) can slide or translate axially within the annular space (85) of the inner slide body (46). When the caliper moves in the axial direction, the caliper legs (87a, 87b) extend through the openings (93a, 93b) in the distal direction.

[0085] like Figure 2 , Figure 3 As shown and Figure 4As shown in the top view of the syringe, the syringe plunger locking plate (108) is connected to the legs (100a, 100b) of the support collar (99) by a pair of diametrically opposed latches (109a, 109b), and the latches (109a, 109b) extend outward from the corresponding opposite sides (110a, 110b) of the plunger locking plate (108). Each latch (109a, 109b) engages with a corresponding longitudinal slot (111a, 111b) of corresponding size provided in the legs (100a, 100b) of the support collar (99). The locking plate latches (109a, 109b) are sized to slide along the slots (111a, 111b) and be guided by the slots (111a, 111b). The locking plate can be moved from a first unlocked position to a second locked position. In the unlocked position, the locking plate (108) is disengaged from the syringe body (3) and the syringe plunger rod (6), and in the locked position, the locking plate engages the syringe body (3) and the syringe plunger rod (6) to prevent axial movement of the syringe body (3) and the plunger rod (6) relative to the locking plate. The locking plate (108) is positioned orthogonal to the central longitudinal axis (21) and moves orthogonally or laterally relative to the central longitudinal axis, and when a user presses the plate (108) from the exposed or open portion (34a, 34b) of the inserter body (17), the opening of the open portion (34a, 34b) is located at the proximal narrowing portion (24) of the inserter body (17). The locking plate (108) is configured to engage with the proximal end (77) of the inner slide body (46). To this end, the locking plate (108) is provided with a pair of parallel, spaced apart and oppositely facing L-shaped projections (113a, 113b) on the distally facing surface (112) of the locking plate, the L-shaped projections (113a, 113b) forming a pair of opposing grooves (114a, 114b) extending along the distally facing surface (112) along respective lateral sides (110a, 110b) and orthogonally relative to the central longitudinal axis (21). The projections (113a, 113b) forming the locking plate grooves (114a, 114b) are sized to engage with the diameter and size of the proximal end (77) of the inner slide body (46) when the locking plate (108) is laterally moved from the unlocked position to the locked position. The grooves (113a, 113b) formed by the L-shaped protrusions (113a, 113b) engage and surround a proximal lip or flange (115) on the proximal and distal facing surfaces (116, 117) of the lip (115), which extends around the outer edge of the proximal end (77) of the inner slide (46). The distal facing surface (112) of the locking plate is also provided with at least one pair, preferably two pairs, of abutment stops (118a, 118b, 118c, 118d) extending from the L-shaped protrusions.The adjacent stops (118a, 118b, 118c, 118d) are constructed, positioned and dimensioned to engage and abut corresponding reverse stops (119a, 119b, 119c, 119d), which are disposed on a distally facing surface (117) of a flange (115) of a proximal end (77) of the inner slidable body (46). The locking plate (108) is provided with a stop and a counter-stop (preventing the locking plate from moving too far laterally and also providing an audible feedback to the user when the locking plate (108) has moved to the correct locked position, thereby securing the proximal end (77) of the syringe body (3) within the inner slidable body (46). The locking plate also includes a generally circular opening (120) extending through the thickness of the locking plate and sized to allow the syringe body (3) and plunger rod (6) of the PFS (2) to be introduced into the automatic inserter device hole (20) in the unlocked position. The adjacent locking plate (108) is provided with a stop and a counter-stop (preventing the locking plate from moving too far laterally and also providing an audible feedback to the user when the locking plate (108) has moved to the correct locked position. The plate opening (120) and forming a continuous joint intersection therewith is provided with an auxiliary opening (121) whose size corresponds to the diameter of the plunger rod (6). Therefore, when the locking plate is laterally moved from the unlocked position to the locked position, the opening 120 is laterally moved and the smaller auxiliary opening (121) is moved to the locked position to engage the outer diameter of the plunger rod (6). In this way, the locking plate (108) serves several purposes, one of which is to lock the plunger rod (6) in the locked position to prevent it from being moved away from the locking plate (108). The locking plate (102a, 102b) is provided to prevent any lateral movement of the syringe body from the central longitudinal axis (21) and also prevent unwanted axial movement of the syringe body relative to other axially movable parts of the inserter device (1). In addition, when the locking plate is moved from the unlocked position to the locked position, the latches (109a, 109b) move within the guide slots (111a, 111b) of the support collar legs (100a, 100b). The support collar legs (111a, 111b) are inserted through the distal openings (101a, 101b) at their respective distal ends (102a, 102b). 1b) is attached to the caliper beam (97) and thus to the fixed point rotation axis (98). Therefore, when the locking plate is moved laterally from the unlocked position to the locked position and the socket of the locking plate slides into and engages the leg slots (111a, 111b), the plunger support collar (99) rotates about the axis (98) from the generally horizontal depressed position of the collar (99) to the generally vertical deployed position of the collar (99), thereby bringing the collar bracket (105) into engagement with the plunger rod (6). As. Figure 5 The perspective view of the automatic inserter device including the locked PFS (2) shown gives an overall representation of this state.

[0086] refer to Fig. 6A and 6BA brief description of the operation of the device is now provided, involving the introduction of the PFS (2) into the automatic insertion device (1) and bringing the PFS (2) into an initial or resting position. The PFS (2) is first introduced into the inserter device with its needle end through the open proximal end (18) of the inserter body (17) and into the bore of the tubular body (76) of the inner slide body (46) through the opening (120) of the locking plate (108) in the unlocked position. The tubular body (76) accommodates the syringe body (3) and engages with the outer surface of the syringe body (3). Since the overall dimensions of the tubular body are designed and constructed to match the outer diameter of the syringe body (3), but additionally, due to the proximal base (122), the proximal base (122) is formed by a radially inwardly extending shoulder (123) provided at the proximal end of the tubular body (76), the syringe body is prevented from being inserted too deeply distally into the tubular body (76) of the inner slide body. The base (122) is also used to position and center the syringe body (3) within the bore of the tubular body of the inner slide body (46). The locking plate (108) is now moved laterally by the user, for example by pressing with the thumb, and it moves from right to left, orthogonal to the longitudinal axis (21) of the inserter device (1). The movement of the locking plate (108) thus causes the L-shaped protrusions (113a, 113b) and the corresponding locking grooves (114a, 114b) to engage and surround the proximal (116) and distal (117) facing surfaces of the proximal flange or lip (115) of the inner slidable body (46). When the locking plate has reached the locked position, an audible signal such as a click is generated by the interaction between the abutment stops (118a, 118b, 118c, 118d) of the locking plate (108) and the counter-stops (119a, 119b, 119c, 119d) located on the distally facing surface of the proximal end of the inner slide body (46). In addition, when the locking plate is laterally moved from the unlocked position to the locked position, the support collar (99) moves from a horizontal depressed position to a vertical deployed position in which the support collar (99) bracket engages the plunger rod (6). Similarly, the locking plate opening (120) is laterally moved by the lateral movement of the locking plate (108) so that the auxiliary opening (121) is aligned axially with the center of the plunger rod (6) and is thereby engaged with the plunger rod (6). In the locked position of the locking plate (108), the syringe body (3) is held between a base (122) located distally of the syringe finger flange (15) and a distal surface of the locking plate (108) located proximal to the syringe finger flange (15), and therefore cannot move axially independently of other axially movable components.

[0087] Fig. 7AA partially cut away enlarged sectional perspective view showing various details of the locking plate (108) in a locked position relative to the support collar (99) of the PFS (2), the plunger rod (6) and the syringe body (3) when in the initial rest position. Similarly, Figure 7B An enlarged bottom view is shown along the central longitudinal axis (21) and shows the relative details of the abutment stops (118a, 118b, 118c, 118d) and counter-stops (119a, 119b, 119c, 119d) as the locking plate (108) moves from the unlocked position to the locked position. Figure 7B It can be seen that the locking plate abuts the stoppers (118a, 118b, 118c, 118d) extending from the L-shaped projections (113a, 113b). Figure 7B From left to right, the abutment stops (118a, 118b) move into abutment contact with the counter-stops (119a, 119b). Continued lateral pressure applied by the user to the locking plate causes the abutment stops (118a, 118b) to be forced past the counter-stops (119a, 119b) until the abutment stops (118c, 118d) hit the counter-stops (119c, 119d), at which point an audible click is produced as the abutment stops (118c, 118d) snap into place between the counter-stops (119c, 119d). The locking plate (108) is now considered to be in the locked position.

[0088] Figure 8 An exploded perspective view of an automatic inserter device (1) without any pre-filled syringe is shown, wherein the various components of the inserter device are arranged along a central longitudinal axis (21), or on either side of the central longitudinal axis (21). For convenience, the same elements are used as in Figures 1 to 46, the inner slide body (46) has a position signal emitting element housing (124) for accommodating a position signal emitting element (125), the signal emitting element housing (124) protruding from and located on the outer facing surface (126) of the slide body (46), at a position away from the radially outwardly extending shoulder (82) and at a 90° position relative to the opening (93a, 93b) in the radially outwardly extending shoulder (82) about the central longitudinal axis (21). The position signal emitting element (125) located in the position signal emitting element housing (124) can be any suitable signal emitting element, when used in conjunction with the position sensor (127), the signal emitting element transmits or allows the determination or calculation of the position of the inner slidable body (46) relative to the component accommodating the position sensor (127). In the present example, the position signal emitting element (125) is usefully a permanent or inductive NS dipole magnet, such as a disk or rod magnet having a single NS dipole. The position sensor (127) is correspondingly and advantageously a magnetometer, although it should be remembered that other known pairings of position signal emitting elements and position sensors can be used to similar effect. The position sensor (127) is housed on a microelectronic circuit board (129), such as a printed circuit including a microcontroller, such as including a built-in processing unit, which is electrically connected or otherwise functionally connected to the position sensor (127). For example, in Figure 8 In the embodiment of the present invention, the position sensor (127) is suitably included in a microelectronic printed circuit board (129) which is located within a position sensor housing (128) disposed in a distal portion of the automatic inserter device body (17). For example, Figure 2 , Fig. 6A , Figure 6B and Fig. 9 The relative positions of the position signal emitting element (125) and the position sensor (127) are shown in enlarged detail, together with a nominal centerline (130) extending orthogonally through the position signal emitting element (125), which nominal centerline is considered to represent position point zero, i.e. the initial rest position when the PFS (2) has been introduced into the automatic inserter device (1) and locked into the locked position. When or if the outer slide body (51) is locked in axial displacement with the inner slide body (46), any changes in the recorded magnetic field or magnetic vector value obtained or determined by the sensor (127) from the position signal emitting element (125) will indicate axial movement of the inner slide body (46) and the outer slide body (51).

[0089] Fig. 10A , Fig. 10B , Fig.11A and Fig. 11Bis a perspective view and a cross-sectional view of the automatic inserter device (1) and a comparative view of the relative positions of the PFS (2), the plunger support collar (99) and the plunger rod (6) when moving from an initial rest position or zero position to a first standby position. Fig. 10B and 11B As can be seen in the figure, the support collar 99 in the standby position has moved in the proximal direction far beyond the proximal end 18 of the inserter body 17. The standby position is a position in which the prefilled syringe (2) is moved in the proximal direction to prepare for firing the prefilled syringe (2) for subsequent axial acceleration in the distal direction before the injection step. The standby position is a position in which the automatic inserter device (1) pre-positions the prefilled syringe (2) and the needle (13) attached to the prefilled syringe (2) so as to quickly or accelerate from the standby position located proximally to an axial position located distally, which is closer to the predetermined target or injection administration site. The inserter device (1) is called an automatic inserter because the step of starting the inserter device (1) to move from the standby position to the distal position ready for injection is equivalent to, for example, pulling a trigger on a firearm, and generally includes a stored energy source or pawl, for example using a biasing element, such as a coil spring, as shown in the figure. When the stored energy (i.e., the spring) is released, typically by activating a trigger mechanism, the released energy is directed in the direction in which the prefilled syringe and needle should be accelerated to enable the needle to penetrate the administration site, whether skin, muscle, or some other target. Naturally, the purpose of the automatic inserter device (1) is to provide only enough directed energy to provide such penetration depth, without pushing the needle too deep, which would likely cause pain and cause the user to avoid reusing the device for subsequent injections. The skilled person is able to provide and design such energy storage and directing mechanisms, and these mechanisms themselves are well known in the art, for example, in injection pen systems that are commercially available for the treatment of diabetes and other diseases.

[0090] To move the automatic inserter device (1) from the initial rest position, the user moves the distal end (53) of the outer slidable body (51) in the proximal direction, for example by pulling or pushing them. The distal end (53) of the outer slidable body (51) is exposed through the distal opening (34b) in the inserter body (17) and is thus accessible to the user. For example, in Fig.11A, it can be seen that the position signal emitting element (125) is aligned with the position sensor element (127). As the user moves the outer slide body (51) in the proximal direction, it also snaps the needle cover holder (35) onto the outer needle cover surface (39) via the needle cover holder friction gripping surface (38), thereby forcing the inwardly facing surface (41) of the needle cover holder (35) to clamp the needle cover (16). As the outer slide body (51) moves in the proximal direction, the needle cover (16) is retained by the needle cover holder (35) because the radially inwardly projecting shoulder (71) of the outer slide body (51) causes compression of the internal biasing spring (72) of the outer slide body (51), which in turn causes the radially outwardly extending shoulder (82) of the inner slide body (46) to be biased against in the proximal direction. As a result of this series of biasing, both the outer slide body (51) and the inner slide body (46) are biased in the proximal direction and move the PFS (2) in the same direction because the PFS (2) is restrained in the locked position by the locking plate (108) and the proximal base (122) of the tubular body (76) of the inner slide body (46). Therefore, the locking plate (108) also moves in the proximal direction with the support collar (99) and the outer and inner slide bodies (51, 46). The total movement distance in the proximal direction of the outer body from the initial rest position is about 20 mm. As the outer slide body (51) moves in the proximal direction, the elastically deformable arm (58) moves axially in the proximal direction to the same extent. When the arm begins to reach the maximum allowable travel distance of the outer slide body in the proximal direction, the arm is pushed against the inclined section (131, 132) having the hook-shaped proximal end (132) of the insert body (17). Fig. 11B ), the inclined section protruding into the hole (20) of the inserter body, causing the elastically deformable arm (58) to elastically deform inwardly into the outer body hole. The elastic deformation of the arm (58) is configured to allow the arm (58) to overcome the resistance pushed by the inclined section and the hooked proximal end (132), at which time the elastically deformable arm (58) quickly jumps back outwardly toward the inserter body (17), and the proximal terminal hook (59) of the deformable arm engages with the hooked proximal end (132) of the inserter body (17) to prevent the outer slide body (51) from being pushed in the distal direction until the inserter device needs to be operated to move the device from the standby position to the injection ready position. In the standby position, the position signal emitting element (125) is farthest from the position sensor (127), so the signal generated is the weakest when the signal emitting element is, for example, a magnet. Therefore, the microelectronic circuit is able to recognize when the automatic inserter device (1) has moved to the standby position.

[0091] Release of the automatic inserter device (1) can be achieved by means of an elastically deformable release button (133), which is advantageously located on the inserter body (17) and is received by it near the proximal end (18) of the inserter body. The elastically deformable release button (133) is provided with a protruding biasing rod (134), which extends through the wall of the inserter body and is positioned to align with the terminal hook (59) of the elastically deformable arm (58). When release from the standby position to the injection ready position is required, the user presses the release button (133), which elastically deforms inwardly and causes the protruding rod (134) to move inwardly into biasing contact with the terminal hook (59), pushing the hook (59) out and deforming the elastically deformable arm so that the terminal hook (59) is out of contact with the hook-shaped proximal end (132) of the inclined section (131). When this occurs, the bias of the outer slide body (51) and the accumulated energy stored by the compressed outer biasing spring (60) cause the outer slide body (51), the inner slide body (46), the locking plate (108), the support collar (99) and the PFS (2) to be pushed in the distal direction into the injection ready position.

[0092] Regarding the above content, Fig.12 An enlarged, partially cut-away cross-sectional view showing the relative positions of the deformable resilient arm (58) and terminal hook (59) with the inclined section (131) and hook-shaped proximal end (132), the resiliently deformable release button (133) and the protruding rod (134). Fig.13 An enlarged view is shown of the needle cover (16) being released from the needle distal end (14) as the outer slider body (51) moves in the proximal direction, and the protection against accidental injection still provided by the presence of the needle cover retainer (35) which has retained the needle cover (16).

[0093] Fig.14A and 14B The relative positions of the components of the inserter device (1) between release from the standby position and the injection ready position are shown. In order to prepare the inserter device (1) for release from the standby position, the user must first remove the needle cover retainer (35) which holds the needle cover (16). This is achieved by pulling on the needle cover retainer friction gripping surface (38), which causes the needle cover retainer to rotate about a rotatable hinge (36) and a corresponding rotation axis (37) to move the needle cover retainer away from the distal end (19) of the inserter device body (17), as shown in FIG. Fig. 14BIt should also be noted that when the outer slide body (51) is moved in the proximal direction to the standby position, the distal locking arm member (64b) is no longer biased by the needle cover retainer (45), and therefore, the proximal locking arm member (64a) of the lever arm safety lock (63) is biased by the lever arm biasing spring (67), causing the lever arm to rotate into the hole (56) and the proximal locking arm member (64a) to be pushed against one of the caliper legs (87a). Similarly, during preparation of the inserter device (1), proximal movement of the inner slide body causes the inner protruding member engagement surfaces (44a, 44b) to move away from engagement contact with the elastically deformable friction clamping member (45).

[0094] As described above, once the needle cover holder (35) has temporarily removed the needle cover (16) from the needle (13), the inserter device (1) can be moved to the injection ready position. The manner in which this is achieved has been described in detail above. It should be noted that when the release button (133) is pressed, the biasing force released from the stored energy embodied by the outer biasing spring (60) is sufficient to cause the distal end of the inner sliding member body to contact the distal end of the inserter body and produce an audible sound. Therefore, this sound can indicate to the user that the injection ready position has been reached. Alternatively, when the automatic inserter device (1) is in the injection ready position, the injection ready position can be detected by a position sensor (137) relative to a signal (e.g., a magnetic vector or magnetic field strength) generated by a position signal emitting element (135) and detected by the position sensor. Fig.15 The relative positions of the components of the inserter device in the injection ready position are shown. In the injection ready position, at least the distal portion of the prefilled syringe (2) extends beyond the distal end (19) of the inserter body (17), and more specifically, the needle (13) extends beyond the distal end (19) of the inserter body (17). The extent or length of the needle (13) extending beyond the end of the inserter body (17) is designed in such a way as to avoid excessive injury to the user and minimize any associated pain caused by the penetration depth of the needle at the administration site. It should be noted herein that the term "injection ready" only means that the prefilled syringe is in a suitable position in which the injection of the product contained in the syringe chamber (4) is implemented, rather than indicating that the injection has actually been performed or activated. The user still has to depress the syringe plunger and rod (6) to expel the product from the chamber to the administration position. This is performed as a subsequent operation to move the slidable bracket assembly (50) and the prefilled syringe (2) inserted therein to the injection ready position.

[0095] The injection of the substance contained in the chamber (4) is carried out by pressing the plunger head (5) of the plunger rod (6). When the plunger head (5) moves in the distal direction and discharges the substance contained in the chamber through the needle (13), the plunger head (5) contacts the bracket (105) of the support collar (99), and due to the interaction of the slots (111a, 111b) of the support collar legs (100a, 100b) and the locking plate latches (109a, 109b), the support collar also translates in the proximal direction. When the plunger has completed its maximum permissible travel distance, that is, when the distal plunger plug (135) attached to the distal end of the plunger rod (6) has reached the distal bottom of the chamber (4) of the syringe body (3), the plunger head contacts the proximally facing surface (136) of the support bracket (105) to prevent any further distal movement of the plunger rod (6) and the plunger head (5), which movement might otherwise result in damage to the inner and outer slide bodies (46, 51). Fig.16 Shown are the relative positions of the components of the automatic inserter device (1) once the injection is complete.

[0096] After the injection is completed, the inner slide body (46) moves together with the locking plate (108) in the proximal direction to the third syringe retracted position. The syringe retracted position corresponds to an axial position along the longitudinal axis of the inserter hole (20) in which the needle no longer extends beyond the distal open end (19) of the inserter hole (20). In this configuration, if the syringe is thrown away together with the inserter body, the third position can be the final position to which the syringe will be moved, but advantageously, the automatic inserter is also configured to be reused, so that the third position is only an intermediate position, the purpose of which is to protect the inserter device (1) and the user from accidents caused by a potentially exposed needle after the injection is completed. In this retracted position, the needle (13) of the PFS (2) is completely contained in the hole (20) of the inserter body (17).

[0097] Movement of the syringe and needle into the needle retracted position is achieved as follows, Fig.16 and 17As shown. The user depresses the transverse rod 103 of the support ring 99. The support collar legs (100a, 100b) are connected to the caliper (92) by diametrically opposed beams (93a, 93b), and the distal movement applied to the caliper body (92) by the support collar legs (100a, 100b) in turn causes the caliper legs (87a, 87b) to move in the distal direction, whereupon the distal ends (137a, 137b) of the caliper legs (87a, 87b) press against and deform the corresponding elastically deformable beams (138a, 138b), which extend obliquely from the outer slider body (51) into the hole (56) in the distal direction. The elastically deformable beams (138a, 138b) have distal feet (139a, 139b) which, prior to any elastic deformation, are in abutting engagement with an annular race (140) extending in a proximal direction from the distal end of the inner slide body (46). The interaction of the distal feet (139a, 139b) and the annular race (140) prevents the inner slide body (46) and the outer slide body from moving independently of each other in a proximal direction. When the distal ends (137a, 137b) of the caliper legs (87a, 87b) move in a distal direction, they slidably engage the elastically deformable beams (138a, 138b), causing the beams to elastically move away from their abutting engagement with the race (140), thereby releasing the inner slide body (46) from being retained by the outer slide body (51). The inner biasing spring (72) of the outer slide body (51) now pushes the inner body (46) in the proximal direction until the seat (140) is in abutting contact with the distally facing surface (141) of the radially inwardly radially protruding shoulder (71) of the outer slide body (51). In this step, the total distance moved by the inner slide body in the proximal direction is about 12 mm. The urging force of the inner biasing spring (72) can be configured to produce an audible sound when the seat abuts against the distally facing surface of the radially inwardly extending shoulder (71), thereby alerting the user to the fact that the needle and the syringe body have been retracted. Alternatively, the movement of the inner body (46) accommodating the position signal emitting element (135) will be detected by the position sensor (137) as an intermediate position, which is proximal compared to the initial rest position and is distal to the standby position and correspondingly proximal to the injection ready position, and can therefore be classified accordingly by the microcontroller and / or processing unit. It should be noted that the distal end (14) of the needle (13) of the PFS (2) is positioned at the correct distance from the distal end (19) of the inserter body to allow it to be re-covered by the needle cover as described below.

[0098] like Fig.19 and 20As shown, an additional safety measure is provided in the form of a lever arm safety lock (63). As has been explained elsewhere in this specification, the lever arm lock (63) has a biased proximal lever arm locking member (64a) that is normally biased against the needle cover holder (35) when the needle cover holder (35) is in the closed position and abuts against the distal locking arm member (64b). However, when the needle cover holder (35) is in the open position, such as when the needle cover holder (35) is in the open position, the proximal lever arm locking member (64a) is normally biased against the distal locking arm member (64b). Fig.18 As shown, the proximal arm locking member (64a) is biased by the lever arm biasing spring (67) to protrude into the hole (56) of the outer slider body (51) and engage with the distal end (137a) of one of the caliper legs (87a). This prevents accidental distal movement of the legs (87a, 87b) and the corresponding risk of pushing the needle from the retracted position to a potential needle injury inducing position before the needle cover retainer (35) and the corresponding needle cover (16) temporarily retained therein have been moved back to the closed position.

[0099] like Fig.19 As shown, once the needle and syringe have reached the syringe retracted position, the needle cover retainer (35) can be moved from the open position to the closed position by rotating about the hinge (37), in which the needle cover retainer closes the previously opened distal end of the inserter device body (17). Doing so will correspondingly move the needle cover (16) back into position for reinstallation onto the distal end (14) of the needle (13). Once returned to the closed position, the needle cover retainer (35) again engages the distal locking arm member (64b) through the contact socket (68), biasing the arm member to rotate about the fulcrum pivot point (65), thereby moving the proximal locking arm member (64a) away from the outer slider body (51) and away from any obstruction to the distal movement of the caliper legs (87a, 87b).

[0100] like Fig. 20 As shown, the caliper legs (87a, 87b) can now be moved in the distal direction again, and pressing downward on the transverse rod (103) of the support collar (99) will move the inner slide body (46) and the caliper (92) and the locking plate (108) in the distal direction to the syringe release position. Engaging the syringe release position moves the inner slidable body (46) and the outer slidable body (51) back to a position that allows the now empty or exhausted syringe to be safely removed from the inserter aperture (20). In particular, the inner protruding member (43) moves distally when the inner protruding member (43) forms a portion of the inner slide member (46) and is in frictional engagement contact with the resiliently deformable friction clamping member (45) of the needle cover retainer (35). This position is Fig.19 and 20, in which it can be seen that the inner slide body (46) and the outer slide body (51) have returned to the initial rest position. This rest position can be detected and recorded by the microelectronic circuit using the position signal emitting element (125) and the position sensor (127) accordingly. In addition, in order to release the PFS (2) from the automatic inserter device (1), the locking plate (108) is again moved laterally in the opposite direction to move the locking plate to the locked position, thereby removing any engagement between the locking plate grooves (114a, 114b) and the proximal lip (115) of the inner slide body (46), but also thereby moving the support collar (99) and the bracket (105) from the expanded or vertical position back to the lower limit or horizontal position. At the same time, the secondary opening (121) of the locking plate is moved away from the plunger rod (6) to the larger sized primary locking plate opening (120), thereby allowing the now empty syringe and covered needle to be safely withdrawn from the automatic inserter device (1) through the proximal end (18) of the inserter body (17).

Claims

1. An automatic inserter for a prefilled syringe system, comprising: an elongated inserter body having proximal and distal ends and a longitudinal bore extending through the elongated body from the proximal end to the distal end, the longitudinal bore having a central longitudinal axis, wherein the elongated inserter body is sized and configured to receive a prefilled syringe introduced into the bore through the proximal end of the inserter body and is also configured and sized to prevent the prefilled syringe from exiting the longitudinal bore through the distal end; In which, the automatic inserter also includes a needle cover holder, which is connected to the distal end of the inserter body by a rotatable hinge, and the needle cover holder is configured to move from a first closed position to a second open position by rotation of the hinge around the rotation axis of the hinge. In the first closed position, before injection, when the prefilled syringe is accommodated in the inserter body, the needle cover holder accommodates the needle cover, which is removably mounted on the injection needle of the prefilled syringe; in the second open position, in preparation for the injection step, the needle cover holder holds the needle cover in a position removed from the prefilled syringe while still being connected to the inserter holder body by the rotatable hinge.

2. The automatic inserter of claim 1, wherein the rotatable hinge has an axis of rotation that is orthogonal to a central longitudinal axis of the inserter body.

3. The automatic inserter according to claim 1, wherein: The hinged needle cover holder is configured to move from the second position back to the first position after injection is completed by rotation of the cover holder about the rotation axis of the hinge to reposition the needle cover back onto the injection needle of the prefilled syringe.

4. The automatic inserter according to claim 1, wherein: The hinged needle cover retainer includes a resiliently deformable friction gripping surface configured to engage with and grip an outer surface of the needle cover.

5. The automated inserter of claim 3, wherein the friction gripping surface comprises an elastomer.

6. The automated inserter of any one of claims 1 to 5, wherein the inserter body includes an internal protruding member located within the bore of the inserter body.

7. The automatic inserter according to claim 1 or claim 6, wherein: The hinged needle cover holder includes a resiliently deformable friction clamping member, which is configured to resiliently deform around and releasably engage an internal protruding member located within the hole of the inserter body in the first closed position, and wherein, in the second position, the friction clamping member of the needle cover holder is not in engagement contact with the internal protruding member.

8. An automatic inserter according to claim 7, wherein the resiliently deformable friction grip member is formed as an extension of the body of the hinged needle cover holder, and the extension protrudes into the hole of the inserter body.

9. The automatic inserter according to any one of claims 1 to 8, wherein: The hinged needle cover retainer, in the first position, completely covers the distal opening of the inserter body aperture.

10. The automatic inserter according to any one of claims 1 to 9, wherein: The hinged needle cover retainer fully opens the distal opening of the inserter body aperture in the second position.

11. An automatic inserter for a prefilled syringe system, comprising: an elongated inserter body having proximal and distal ends and a longitudinal bore extending through the elongated body from the proximal end to the distal end, the longitudinal bore having a central longitudinal axis, wherein the elongated inserter body is sized and configured to receive a prefilled syringe introduced into the bore through the proximal end of the inserter body and is also configured and sized to prevent the prefilled syringe from exiting the longitudinal bore through the distal end; wherein the inserter body includes a syringe body support assembly slidably disposed within the aperture, the support assembly being configured to receive and at least partially surround the syringe body, The slidable support assembly includes a translation system, which is configured to translate the slidable support assembly and the syringe body accommodated in the slidable support assembly from at least a first axial position to at least a second axial position along the central longitudinal axis of the inserter body hole, and the second axial position is axially away from the first position.

12. An automatic inserter according to any one of claims 1 to 10 or claim 11, wherein: The inserter body includes a syringe plunger locking plate.

13. An automatic inserter according to any one of claims 1 to 10 or claims 11 to 12, wherein: The syringe plunger locking plate is configured and adapted to move from an unlocked position, wherein the locking plate is disengaged from the syringe plunger, to a locked position, wherein the locking plate engages the syringe plunger and prevents axial movement of the syringe plunger relative to the locking plate.

14. The automatic inserter according to claim 12 or 13, wherein: The locking plate is configured to be moved from the first unlocked position orthogonal to the syringe plunger and the proximal end of the syringe body to the second locked position.

15. The automatic inserter according to any one of claims 13 to 14, wherein: The locking plate has a first end that extends outside of the inserter body in the unlocked position and is completely contained within the aperture of the inserter body in the locked position.

16. An automatic inserter according to any one of claims 1 to 10 or claims 11 to 15, wherein: The slidable syringe body support assembly includes a first axially movable barrel coaxially located within the inserter bore, and a second axially movable barrel coaxially located within the hole of the inserter bore, and preferably the second axially movable barrel is coaxially located within the hole of the first movable barrel.

17. The automatic inserter according to claim 16, wherein: The first axially movable cylinder and the second axially movable cylinder are configured to move axially within the inserter body bore independently of each other.

18. The automatic inserter according to claim 16, wherein: The first axially movable cylinder and the second axially movable cylinder are configured to move axially together within the inserter body bore.

19. The automatic inserter according to claim 11, wherein: The at least first axial position is an initial rest position.

20. The automatic inserter according to claim 11, wherein: The at least one other axial position is a standby position in which the prefilled syringe is moved in the proximal direction to prepare the prefilled syringe for a subsequent axial acceleration in the proximal direction prior to an injection step.

21. The automatic inserter according to claim 11, wherein: The at least one other axial position is an injection-ready position in which at least a distal portion of the pre-filled syringe extends beyond the distal end of the inserter body.

22. An automatic inserter according to claims 11, 12 and 17 or claims 12, 17 and 21, wherein the slidable syringe body support assembly includes the first axially movable cylinder and the second axially movable cylinder, and the slidable syringe body support assembly is moved together with the locking plate in the proximal direction to the standby position simultaneously.

23. The automatic inserter of claim 22, wherein: Moving the slidable carriage assembly to the armed position causes the needle cover at the distal end of the pre-filled syringe to be retained within the needle cover retainer.

24. The automatic inserter according to claims 1 and 20, wherein: The needle cover holder is configured to move from the first closed position to the second open position when the first axially movable cylinder, the second axially movable cylinder, and the locking plate are in the armed position.

25. The automatic inserter of claim 21, wherein: The slidable syringe body mount assembly includes the first axially movable barrel and the second axially movable barrel, and the slidable syringe body mount assembly is configured to move together with the locking plate in a distal direction to the injection ready position simultaneously.

26. The automatic inserter of claim 17, wherein: The second axially movable barrel of the slidable syringe body support assembly is configured to move in a proximal direction with the locking plate to a syringe retraction position.

27. The automatic inserter of claim 11, wherein: The needle cover retainer is configured to move from the second open position to the first closed position when the second axially movable barrel and the locking plate are in the syringe retracted position.

28. The automatic inserter of claim 11, wherein: The second axially movable barrel of the slidable syringe body support assembly is configured to move in a distal direction with the locking plate to a syringe release position.

29. The automatic inserter of claim 12, wherein: The locking plate includes a locking device configured to releasably engage a proximal end of the second axially movable barrel of the slidable stent assembly.

30. The automatic inserter of claim 12, wherein: The locking plate includes a plunger rod support collar extending in a proximal direction from the locking plate so as to be in sliding contact with at least a portion of the plunger rod, the support collar being configured to move from a depressed state to an expanded state or vice versa.

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