Automatic inserter for handheld pen injection system

Abstract

An automatic inserter for a pre-filled injection syringe system, comprising an elongated body having a longitudinal bore and a central longitudinal axis, configured to receive a pre-filled injection syringe introduced into the bore via a proximal end of the body, further comprising a needle cap holder connected to a distal end of the inserter via a movable joint. The cap holder is configured to rotate about a joint from a first closed position to receive a needle cap prior to injection to a second open position in preparation for the injection process. In the second open position, the needle cap is removed from the pre-filled injection syringe and is held by the cap holder. The cap holder is connected to the inserter body via a joint.

Description

[Technical field]

[0001] FIELD OF THEINVENTION The present invention relates generally to accessories for pre-filled injection syringe systems, and more particularly to an automatic inserter for a pre-filled syringe system or device. [Background technology]

[0002] Pre-filled injection syringe systems, or systems also abbreviated as PFS systems or devices, are well known per se and are used to administer a variety of different therapeutic or pharmaceutical products or formulations, often prepared as solutions of various viscosities. PFS systems generally comprise a main syringe body forming a chamber that contains the medicament to be administered, and an internal movable plunger head located within the syringe body chamber, which is usually controlled by a plunger shaft connected to the plunger head and extends out and beyond the proximal open end of the syringe body. The distal end of the syringe body usually includes a shoulder and neck portion of narrower diameter than the syringe body, and a hypodermic injection needle may be attached to the neck or a cannula inserted into the proximal opening of the syringe body to allow the transfer of the medicament from the chamber of the syringe body to the patient or subject receiving the injection. It will be understood that "proximal" refers to a point that is directed toward the body or hand of the user manipulating the PFS, and "distal" refers to a point that is directed away from the body of the user of the PFS. When 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 of the hand that manipulates the PFS to perform the injection, and "distal" refers to a point that is directed toward the injection site. The syringe body may optionally and usefully comprise a gripping surface, such as a finger grip means or flange, located at the proximal end of the syringe body to enable a user of the PFS to grasp the syringe body with two fingers of one hand and press the plunger shaft proximally with the thumb, thereby moving the plunger head proximally to expel the product contained within the main chamber of the syringe body through the needle or cannula. The distally located needle or cannula is often covered with a removable needle guard or cover, which is typically manually removed prior to injection to expose the needle and allow for introduction of the needle into the injection recipient's body, whether that part of the body is the skin, muscle, or some other body part.At this point, and any time the needle or cannula is exposed, there is a known risk of accidental exposure to the needle or cannula tip, with a corresponding risk of injury, or potentially worse, mis-administration of the product contained within the syringe body chamber. Summary of the Invention [Problem to be solved by the invention]

[0003] The above types of PFS systems are used by both medically trained and non-medically trained users. While medically trained users are accustomed to operating such devices after appropriate training, non-medically trained individual users, such as patients themselves, may still struggle to use these PFS devices accurately and / or properly. Manufacturers of such PFS systems have attempted to make such systems as easy and reliable to use as possible, and to minimize the risk of accidental injury from the use of such devices. Typically, this has been accomplished by devising ways to make access to the PFS more or less hidden and to reduce actual physical contact with the PFS.

[0004] Despite the above developments, difficulties remain, at least for many users, in using such PFS systems correctly, even if they are concealed by the accessories. For example, some users who need to administer drugs provided by such PFS systems also exhibit general neurological and / or muscular coordination difficulties, making operation of the PFS system and associated accessories incomplete, imprecise or non-precise. Other users fear seeing, handling or otherwise manipulating needles, including inserting them into the body, and thus face significant psychological challenges when attempting to use most commonly available commercial PFS systems, despite the relative improvements in user ease of use. Such challenges can affect the well-being of patients and, more importantly, compliance with treatment regimens that device users-patients are supposed to follow, including such pen injection systems.

[0005] As a result, some attempts have been made to overcome the above difficulties by providing automatic or semi-automatic needle inserters, also known as automatic inserters. The purpose of such an automatic inserter, which can be considered as a separate device in itself and an accessory to the PFS, is to facilitate the presentation of the needle of the PFS at the correct angle for insertion into the body at the injection site, to allow the user to place the PFS in the automatic inserter, arm the automatic inserter so that the PFS is ready for injection, and then release the armed injection pen system so that the user is avoided from facing the sight of having to prick themselves with the needle of the PFS.

[0006] For example, published US patents US5980491A and US6537252B1 both relate to an automatic inserter for a pen-type injection syringe, the device comprising a tubular housing in which an injection pen is mounted in a tubular pen holder, the pen holder being axially movable along a longitudinal axis of the pen and the automatic needle inserter in a proximal direction, i.e., toward the user's hand and / or body, to cock a spring that is subsequently released to drive the pen holder together with the pen distally a set distance. The holder inserter holder injection pen is distally connected to a drug-containing cartridge and a needle mounted at the distal end of the drug-containing cartridge. This system is unique to products manufactured and commercialized by the applicants of these patents.

[0007] Furthermore, published French patent application FR3079422A1 relates to another automatic inserter configured to receive an injection pen system, such as an insulin injection pen, comprising a body with a holder for the injection system, the body being configured to move from an armed position to an unarmed position via the actuation of a command member, thereby allowing axial displacement of the holder. The automatic inserter body comprises a threaded clamping ring system that allows the insertion of the injection pen system into the automatic inserter body. The threaded clamping ring system comprises an engagement surface with a proximal frustoconical inner surface that, via a screwing action of the clamping ring, gradually engages with an outer surface of a correspondingly shaped frustoconical hollow deformable part, whereby the plastic ring is compressed, thereby reducing the diameter of the opening from a first wider diameter position, allowing free axial movement of the pen injection system, to a second narrower diameter position, where the plastic ring is held pressed against the body of the pen injection system. [Means for solving the problem]

[0008] As used herein, the terms "PFS system or device" and "pre-filled syringe system or device" are used interchangeably to refer to a generally hand-held pre-filled syringe as generally described above, and such PFS systems are quite well known in themselves and are commercially available for use in the treatment of many different medical indications. These systems are also generally often designed for self-injection of drugs by the user who needs treatment for a given medical indication. This is the case, for example, of insulin, which is supplied in various forms for use in the treatment of diabetes. Similar configured PFS systems are also available or have been used for the treatment of other physiological and / or pathological conditions, using various injectable formulations containing active ingredients such as, for example, adrenaline, epinephrine, methotrexate, recombinant monoclonal antibodies, human growth hormone, hyaluronic acid, etc.

[0009] Accordingly, one aspect of the present invention is to provide an automatic inserter for a PFS system that is adapted to accept and function with the 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 to use and handle, safer and more reliable than known solutions.

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

[0012] Another aspect of the present invention is to provide an automatic inserter for a PFS system that reduces the likelihood of a user accidentally stabbing themselves with a needle.

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

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

[0015] Thus, according to any of the above aspects, there is provided an automatic inserter for a pre-filled injection syringe system, comprising: an elongate inserter body having a proximal end and a distal end; and a longitudinal bore extending through the elongate body from the proximal end to the distal end, the longitudinal bore having a central longitudinal axis, the elongate inserter body being dimensioned and configured to receive a pre-filled injection syringe introduced into the bore through the proximal end of the inserter body, and further configured and dimensioned to prevent the pre-filled injection syringe from exiting the longitudinal bore through the distal end; The automatic inserter further comprises a needle cap holder connected to the distal end of the inserter body via a rotatable joint, the needle cap holder configured to be moved via rotation of the joint about a rotation axis of the joint from a first closed position in which the needle cap holder receives a needle cap removably attached to an injection needle of the pre-filled injection syringe when the pre-filled syringe is received in the inserter body prior to an injection, to a second open position in preparation for an injection process in which the needle cap holder remains connected to the inserter holder body via the rotatable joint and holds the needle cap in a position removed from the pre-filled injection syringe.

[0016] As mentioned above, the elongated inserter body is dimensioned and configured to receive a pre-filled syringe system introduced into the bore of the inserter body via the proximal end of the inserter body. Such configuration presupposes an opening of the bore at the proximal end of the elongated inserter body, the opening being dimensioned sufficiently to allow insertion of at least the distal end of the pre-filled syringe into said opening and into the longitudinal bore. The overall shape of the elongated inserter body is cylindrical, although it is also possible to provide suitably dimensioned, shaped and configured enlargements and / or reductions of the bore along the length of the inserter body.

[0017] Furthermore, the elongated inserter body is suitably configured and dimensioned to prevent the pre-filled syringe from exiting the longitudinal bore via the distal end of the inserter body. This can be achieved in various ways, for example by providing one or more abutting shoulders projecting inwardly from the inner surface of the elongated inserter body, or by providing other forms of suitable abutments to prevent over-insertion of the pre-filled syringe along the axial length of the inserter body or components disposed therein located within the bore. Particularly advantageous solutions in this regard are provided in more detail herein.

[0018] The automatic inserter also comprises a needle cap holder connected to the distal end of the inserter body via a rotatable joint. The rotatable joint can be, for example, a simple hinge, or an axle or a pin and hole mechanism, similar to those commonly found in watch straps. The needle cap holder is movable from a normal closed position, for example when the inserter is not in use or during the introduction of a pre-filled syringe into the inserter body, to an open position in which the needle cap holder no longer closes the distal end opening of the inserter body. The cap holder is moved by rotating the joint about an axis of rotation. When in the closed position, the needle cap holder receives and holds a needle cap that is typically attached to the pre-filled syringe or to the distal end of a cannula inserted into the pre-filled syringe. Such needle caps are commonly found used with pre-filled syringes to protect the user from accidental needle pricks. Since the needle cap holder holds the needle cap in the closed position, when the cap holder is moved to the open position, the cap holder temporarily removes the needle cap away from the pre-filled injection syringe or to a position to be removed from the pre-filled injection syringe, even though the cap holder remains connected to the inserter holder body via a rotatable joint. This is in contrast to certain known needle cap removers, which are configured to receive and remove the needle cap prior to injection, but which generally suffer from the disadvantage that the needle cap is separate from the pre-filled syringe system and may be lost, misplaced, or replaced when needed again and / or incorrectly, resulting in potential damage from an exposed needle after injection.

[0019] According to another aspect, the rotatable joint has an axis of rotation perpendicular to the central longitudinal axis of the inserter body, In such a configuration, the needle cap holder can rotate away from and towards the inserter body holding the pre-filled syringe without interfering with the action of preparing and performing an injection.

[0020] The articulated needle cap holder is therefore also configured to be moved from the second position back to the first position via rotation of the cap holder about the articulated axis of rotation after the injection is completed, thereby repositioning the needle cap onto the injection needle of the pre-filled injection syringe.

[0021] According to one embodiment, the articulating needle cap holder includes a resiliently deformable frictional gripping surface configured to engage and grip the outer surface of the needle cap. For example, advantageously, the frictional gripping surface includes an elastomer. The elastomer is easily selected from a known list of available elastomers known to provide sufficient frictional grip and abutting contact with the outer surface of the needle cap. The gripping surface can be provided via a set of generally V-shaped or open cone-shaped projections extending from a face of the needle cap holder facing inwardly toward the distal opening of the inserter body bore. Additionally, the needle cap holder can also advantageously have a body constructed from the same elastomer, which forms a generally disk-shaped or circular obscurator to cover the inserter body bore opening located at the distal end of the inserter body. The set of V-shaped or inverted conical projections are configured to encase and frictionally engage an outer surface of the needle cap, which is generally conical in shape, whereby the conical nose of the needle cap is received and encased by the corresponding conical or V-shaped projections of the needle cap holder.

[0022] According to another aspect, the inserter body includes at least one inwardly projecting member located within the bore of the inserter body. The inwardly projecting member may be suitably provided at a distal location within the bore of the inserter body, e.g., projecting into the bore from a sidewall of the bore, e.g., substantially perpendicular to a longitudinal axis of the inserter body. The inwardly projecting member may be dimensioned and configured to provide an additional engagement surface with which the needle cap holder may engage, e.g., to ensure that the cap is held against the bore opening when the cap holder is in the first closed position.

[0023] Thus, according to yet another aspect, the articulating needle cap holder comprises an elastically deformable frictional gripping member configured in a first closed position to elastically deform around and releasably engage with an inner projection member located in the bore of the inserter body. It should be understood that in a second position, the frictional gripping member of the needle cap holder is free from any abutting contact with the inner projection member. Such inner projection member can therefore be correspondingly free to move or remain in its original position as required and / or necessary. As will be explained below, advantageously, the inner projection member can be suitably attached to or extend from a movable member located in the bore of the inserter body. In such a configuration, the inner projection member is available to the frictional gripping member of the needle cap holder only at a specific position of the movable member to which such inner projection member is provided.

[0024] According to yet another aspect, the elastically deformable frictional gripping member is formed as an extension of the body of the articulating needle cap holder, which extension protrudes into the bore of the inserter body when the needle cap holder is in the first closed position.

[0025] As described above, in the first position, the articulating needle cap holder completely covers the distal opening of the inserter body bore and correspondingly, when the articulating needle cap holder is in the second position, the distal opening of the inserter body bore is left unobstructed by the cap holder and is fully open for the injection operation to be prepared and performed.

[0026] According to another aspect, an automatic inserter for a pre-filled injection syringe system includes: an elongate inserter body having a proximal end and a distal end; and a longitudinal bore extending through the elongate body from the proximal end to the distal end, the longitudinal bore having a central longitudinal axis, the elongate inserter body being dimensioned and configured to receive a pre-filled injection syringe introduced into the bore through the proximal end of the inserter body, and further configured and dimensioned to prevent the pre-filled injection syringe from exiting the longitudinal bore through the distal end; the inserter body includes a slidable syringe body carriage assembly disposed within the bore configured to receive and at least partially surround the syringe body; An inserter body is provided, wherein the slidable carriage assembly includes a translation system configured to translate the slidable carriage assembly and a syringe body received therein along a central longitudinal axis of the inserter body bore from at least a first axial position to at least a second axial position axially spaced from the first position.

[0027] According to this aspect, the inserter body includes a slidable syringe body carriage assembly. The slidable carriage assembly is designed and configured to at least partially surround the syringe body, but is also adapted to move the syringe body in and along the longitudinal axis of the inserter body bore such that the syringe body of the pre-filled syringe can be easily positioned at several key positions along the desired and intended function of the automatic inserter. Thus, the slidable carriage assembly includes a translation system configured to translate the slidable carriage assembly and the syringe body received therein from at least a first axial position along the central longitudinal axis of the inserter body bore to at least a second axial position axially spaced from the first position. For example, there are at least two primary positions to which it is desirable to be able to move the slidable carriage assembly holding the syringe body of the pre-filled syringe. A first such position would be, for example, an armed position, in which the pre-filled syringe is, for example, placed in a position within the bore of the inserter body that allows it to be accelerated via a suitably organized movement mechanism, such as, for example, a spring-loaded detent. A second such position would be, for example, an injection-ready position, in which the pre-filled syringe has been moved, properly speaking, in preparation for an injection step, i.e., a step in which the plunger of the pre-filled syringe is manipulated to expel the product from the chamber into any part of the body that is the intended target area for administration. Other suitable or advantageous positions for the slidable carriage assembly are also possible and will be discussed in further detail herein.

[0028] According to another aspect, the slidable syringe body carriage assembly comprises a first axially movable cylinder coaxially disposed within the inserter bore and a second axially movable cylinder coaxially disposed within the inserter bore, preferably within the bore of the first movable cylinder. The first and second axially movable cylinders are thus axially movable along a central longitudinal direction of the inserter body, one moving within the other, preferably with the second cylinder moving within the first cylinder. Furthermore, the first and second cylinders are configured to be movable within the bore of the inserter body.

[0029] According to yet another aspect, the first axially movable cylinder and the second axially movable cylinder are configured to be moved axially within the inserter body bore independently of each other. According to another aspect, as described above, the first axially movable cylinder and the second axially movable cylinder are configured to be moved axially together within the inserter body bore. The reasons for this desired freedom of axial movement of the first and second movable cylinders will become apparent upon further reading of this specification.

[0030] According to a further aspect, and as stated above as desirable and advantageous, at least the first axial position is an armed position where the pre-filled syringe is moved proximally to prime the pre-filled syringe for subsequent proximal axial acceleration prior to the injection step. The armed position is a position where the automatic inserter pre-positions the pre-filled syringe and its attached needle to be rapidly moved or accelerated from the armed position to a position generally closer to the intended target or administration site of the injection, axially away from the armed position. The inserter is called an automatic inserter because the process is equivalent to, for example, pulling the trigger of a firearm, and typically involves some sort of stored energy or detent, for example using a biasing element such as a coil spring. When the stored energy, for example a spring, is released, typically by actuation of a trigger mechanism, the energy is directed in a direction that accelerates the pre-filled syringe and the needle so that the needle penetrates the skin, muscle, or other target site, which is the administration site. Of course, the aim of an automatic inserter is to provide just enough energy to ensure such a penetration depth, without pushing the needle too deep, which may cause pain and may dissuade the user from reusing the device for subsequent injections. Those skilled in the art are capable of providing and designing such energy storage and directing mechanisms, which are well known per se in the art, for example in injection pen systems commercially available for the treatment of diabetes and other diseases. Such mechanisms, also in the case of an automatic inserter, may serve well in the present case.

[0031] According to another object, and as mentioned above, at least the second axial position is a ready-to-inject position in which at least a distal portion of the pre-filled syringe extends beyond the distal end of the inserter body. The length that the distal portion of the pre-filled syringe extends beyond the end of the inserter body, particularly the length that the needle extends, is designed to avoid excessive trauma to the user and to minimize pain associated with the needle's penetration depth at the administration site. It should be noted that the term "ready-to-inject" in the present context only means that the pre-filled syringe is in a suitable position to inject the product in the syringe chamber, but does not mean that an injection has actually been performed or activated. To expel the product in the chamber to the administration site, the user must depress the syringe plunger. This is performed as a subsequent operation to moving the slidable carriage assembly and the pre-filled syringe inserted therein to the ready-to-inject position.

[0032] According to yet another aspect, the inserter body is comprised of a syringe plunger locking plate that serves several purposes, one of which is to lock the plunger against any axial movement relative to the locking plate, but does not prevent unitary axial movement of the locking plate and plunger in the axial direction.

[0033] Thus, in another aspect, the syringe plunger locking plate is configured and adapted to move from an unlocked position to a locked position, where the locking plate disengages from the syringe plunger and where the locking plate engages the syringe plunger to prevent axial movement of the syringe plunger relative to the locking plate.

[0034] Thus, according to one aspect, the locking plate is configured to engage the proximal end of the syringe body. The locking plate can advantageously be shaped to abut, contact, encase, and engage the proximal end of the syringe body, e.g., a finger flange.

[0035] According to another aspect, the locking plate may be advantageously configured, for example, to move orthogonally relative to the syringe plunger and the proximal end of the syringe body when moving from the first unlocked position to the second locked position. In such a configuration, the locking plate is spaced apart from the syringe plunger and the proximal end of the syringe body when in the first position. The plate may be moved from the first unlocked position by, for example, sliding orthogonally relative to the central longitudinal axis along a series of parallel rails or grooves provided in the inwardly facing wall of the inserter body, transverse to the length of the bore, toward the proximal end of the syringe body. The locking plate may be advantageously provided, for example, with a distally extending flanged groove that moves around, seals against, and engages a finger flange, for example, at the proximal end of the syringe body, when the second locked position is reached. In the unlocked first position, the locking plate can advantageously present a first end that extends outside the inserter body, while in the locked position the first end is fully housed within the bore of the inserter body. This has the advantage of clearly indicating to the user whether the locking plate is engaged in the first or second position, and furthermore allows the locking plate to be easily moved either to or from the locked position by simply pushing or pulling, respectively, the first end of the locking plate. Moreover, only in the locked position can the plate be freely moved within the bore of the inserter body. Moreover, only in the locked position can the plate be freely moved within the bore of the inserter body.

[0036] Thus, according to one aspect, a slidable syringe body carriage assembly including a first axially movable cylinder and a second axially movable cylinder is moved together with the locking plate in a proximal direction to a first armed position, such that moving the carriage assembly to the armed position simultaneously causes movement of the locking plate.

[0037] According to another aspect, a needle cap located at a distal end of a pre-filled syringe is retained in a needle cap holder by movement of the slidable carriage assembly to a first loaded position. As described above, the needle cap is retained by frictional engagement between the needle cap holder and the needle cap, which is configured to provide a greater resistance to separation from the needle cap holder than a corresponding resistance to separation between the needle cap holder and a shoulder of the syringe body, such that when the syringe body with the slidable carriage is moved to the loaded position, i.e., in a proximal direction away from the distal end of the needle cap holder and inserter body, the needle cap is retained by the cap holder and separated from the shoulder of the syringe body.

[0038] Thus, when the first axially movable cylinder, the second axially movable cylinder, and the locking plate are in the first armed position, the needle cap holder can be moved from the first closed position to the second open position because the exposed needle has been moved in a proximal direction away from possible contact with a user's hand, thereby avoiding an accidental needle stick injury.

[0039] According to yet another aspect, a slidable syringe body carriage assembly including a first axially movable cylinder and a second axially movable cylinder are configured to be moved together with the locking plate in a distal direction to a second, ready-to-inject position when a trigger for energy storage is actuated. The trigger and energy storage form part of a movement mechanism for the automatic inserter, and use solutions commonly known to those skilled in the art, such as a biasing spring, to bias the movable cylinder and the locking plate to the ready-to-inject position.

[0040] According to another aspect, the second axially movable cylinder of the slidable syringe body carriage assembly is configured to be moved proximally with the locking plate to a third syringe retracted position. This third syringe retracted position preferably includes only the second axially movable cylinder and the locking plate and corresponds to an axial position along the longitudinal axis of the inserter bore where the needle no longer extends beyond the distal open end of the inserter bore. In this configuration, if the syringe is to be discarded together with the inserter body, the third position may be the final position to which the syringe is moved, but since the purpose is that the automatic inserter is to be reused, the third position is only an intermediate position, the purpose of which is to protect the inserter and the user from accidents with a potentially exposed needle after an injection is completed. In this position, the needle of the syringe is fully contained in the bore of the inserter.

[0041] Thus, according to another aspect, in the syringe retracted position, the needle cap holder can be moved from the second open position to the first closed position, thereby correspondingly returning the needle cap to a position for replacement or reattachment to the distal end of the needle.

[0042] According to yet another aspect, the second axially movable cylinder of the slidable syringe body carriage assembly is configured to be moved distally with the locking plate to a fourth syringe release position that returns the movable cylinder to a position that allows the now empty or used syringe to be removed from the inserter bore. Additionally, the locking plate can be slid back to a first unlocked position where the first end of the plate extends beyond the inserter body wall, further preventing any proximal movement of the cylinder.

[0043] As described above with respect to the locking plate, according to another aspect, the locking plate includes a locking means configured to releasably engage a proximal end of the second axially movable cylinder of the slidable carriage assembly. Such locking means may be, for example, a grooved flange on the locking plate that is shaped to receive, support and engage at least a portion of the proximal end of the finger flange of the syringe body.

[0044] According to yet another aspect, the locking plate includes a plunger shaft support collar extending proximally from the locking plate for sliding contact with at least a portion of the plunger shaft, the support collar configured to move from a collapsed state to an unfolded state or from the unfolded state to a collapsed state. The support collar serves several purposes, including providing a contact surface for the proximal end of the plunger when an injection is being performed. When the proximal end of the plunger contacts the proximally facing contact surface of the support collar, excessive force is prevented from being applied to the movable cylinder.

[0045] These and other objects of the present invention will become apparent and will be explained in more detail in the following description of the drawings and exemplary monitoring module.

[0046] The invention will now be described in more detail with reference to the accompanying drawings, provided for purposes of illustration and example, in which: [Brief description of the drawings]

[0047] [Figure 1] FIG. 1 is a schematic side view of an automatic inserter according to the present invention with a pre-filled syringe loaded into the inserter. [Diagram 2] FIG. 2 is a schematic cross-sectional view of the inserter of FIG. [Diagram 3] FIG. 3 is a schematic alternative cross-sectional view of the inserter of FIGS. 1 and 2 rotated approximately 90°. [Figure 4]FIG. 4 is a schematic top view of the inserter of FIG. 1 taken along its central longitudinal axis. [Diagram 5] FIG. 5 is a schematic perspective view of the inserter of FIG. [Figure 6A] 6A and 6B are schematic cross-sectional views of a first relative position configuration of some of the inserter components. [Figure 6B] 6A and 6B are schematic cross-sectional views of a first relative position configuration of some of the inserter components. [Figure 7A] 7A and 7B are schematic, enlarged, fragmentary views of details of some of the components of the inserter. [Figure 7B] 7A and 7B are schematic, enlarged, fragmentary views of details of some of the components of the inserter. [Figure 8] FIG. 8 is an exploded perspective view of the inserter of FIG. 1, without the pre-filled syringe installed. [Figure 9] FIG. 9 is an enlarged partial view of another detail of the inserter. [Figure 10A] 10A and 10B are schematic perspective views of the inserter of FIG. 1, showing the relative positions of the pre-filled syringe and other components of the inserter. [Figure 10B] 10A and 10B are schematic perspective views of the inserter of FIG. 1, showing the relative positions of the pre-filled syringe and other components of the inserter. [Figure 11A] 11A and 11B are schematic cross-sectional views of the inserter shown in FIGS. 10A and 10B. [Figure 11B] 11A and 11B are schematic cross-sectional views of the inserter shown in FIGS. 10A and 10B. [Figure 12] FIG. 12 is an enlarged partial view of another detail of the inserter. [Figure 13] FIG. 13 shows an enlarged partial view of different details of the inserter. [Figure 14A] 14A and 14B are schematic cross-sectional views of some of the relative positions of the components of the inserter. [Figure 14B]14A and 14B are schematic cross-sectional views of some of the relative positions of the components of the inserter. [Figure 15] FIG. 15 is a schematic cross-sectional view of the inserter in the ready-to-inject position. [Figure 16] FIG. 16 is a schematic cross-sectional view of the inserter shown in FIG. 15 in the cocked position and rotated approximately 90°. [Figure 17] FIG. 17 is an enlarged partial view of a detail of the inserter. [Figure 18] FIG. 18 is a schematic cross-sectional view of the relative position of the syringe within the inserter in the retracted position. [Figure 19] FIG. 19 is a further schematic cross-sectional view of the relative position of the syringe within the inserter in the retracted position, showing further detail. [Figure 20] FIG. 20 is a schematic cross-sectional view of the relative position of the syringe within the inserter in another position. [Figure 21] FIG. 21 is a schematic cross-sectional view of the relative position of the syringe after it has been withdrawn from the inserter following use. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0048] Referring now to the drawings, Figures 1 and 2 show a schematic side view (Figure 1) and a cross-sectional view (Figure 2) along axis A-A', i.e. from the left side of Figure 1, of an automatic inserter (1) according to the present invention, with a pre-filled syringe (2) introduced into the inserter. The pre-filled syringe (2), or "PFS system or device", or "PFS" for short, as used herein, generally refers to a hand-held pre-filled syringe, such PFS systems being readily known per se and commercially available for use in the treatment of many different medical indications. A PFS system generally comprises a syringe body (3) forming a chamber (4) (see Figure 2) for containing the medicinal product to be administered, and an internal movable plunger head (5) located within the syringe body chamber (4) and typically connected to the plunger head (5) and controlled by a plunger shaft (6) extending beyond the proximal end (7) of the syringe body (3) having an opening (8). The distal end (9) of the syringe body (3) typically includes a shoulder (10) and neck (11) portion of smaller diameter than the syringe body (3), and a distal opening (12) where a hypodermic injection needle (13) having an open distal end (14) can be attached to the neck (11) via a needle attachment connector that engages the neck (11) and shoulder (10) in a known manner, e.g., by threading, or via a cannula inserted into the distal opening (12), to enable transfer of a medicinal product from the chamber (4) of the syringe body (3) to a patient or subject receiving an injection. From the preceding description, it will be understood that "proximal" refers to a point generally directed toward the body or hand of a user operating the PFS, and "distal" refers to a point directed away from the body of a user of the PFS. When 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 the point in the direction of the hand that manipulates the PFS to deliver the injection, and "distal" refers to the point pointed toward the injection site.The syringe body (3) may optionally and usefully be provided with a gripping surface, such as a finger grip means or flange (15), located at the proximal end (7) of the syringe body (3), which allows a user of the PFS to grasp the syringe body (3) with two fingers of one hand and press the plunger head (5) proximally with the thumb, thereby displacing the plunger shaft (6) distally to expel the product contained within the primary chamber (3) of the syringe body through the distal opening (14) of the needle (13) or cannula. The distally located needle (13) or cannula is often covered with a removable needle guard (16) or cover, which is typically removed manually prior to injection to expose the needle (13) and allow for introduction of the needle into the body of the injection recipient, whether that part of the body is the skin, muscle or other body part. At this point, and whenever the needle (13) or cannula is exposed, there is a known risk of accidental exposure to the needle (13) or cannula tip, and a corresponding risk of damage or potentially worse mis-administration of the product contained within the syringe body chamber (3).

[0049] As shown in the figures, the automatic inserter (1) includes 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), the elongated inserter body (17) sized and configured to receive a pre-filled injection syringe (2) introduced into the bore (20) via the proximal end (18) of the inserter body (17) along the central longitudinal axis (21). Such configuration assumes that an opening (22) of the bore (20) at the proximal end (18) of the elongated inserter body (17) is sufficiently sized to permit insertion of at least the distal end (9) of the pre-filled syringe (2) therein and into the longitudinal bore (20). While the overall shape of the elongated inserter body (17) is cylindrical, it can be seen from Figures 1 and 2 that the body also includes an enlargement (23) and / or a narrowing (24) of the bore along the length of the inserter body (17). The narrowing (24) may be suitably formed, for example, as one or more abutting shoulders (24a, 24b, 24c, etc.) projecting inwardly from the inner surface (25) of the elongated automatic inserter body, or any other form of abutment suitable for preventing over-insertion of a pre-filled syringe along the axial length of the automatic inserter body, or other internally located component located within the bore, as described herein.

[0050] The automated inserter (1) also includes actuatable positioning, locking and stabilizing means for maintaining the PFS (2) in a series of sequenced predetermined axial and lateral positions, thereby limiting relative axial movement of the PFS within the inserter (1) and preventing it from exiting the longitudinal bore (20) via the distal end (19) of the inserter body (17). Details of these actuatable positioning, locking and stabilizing means are provided below, but as shown in Figures 1 and 2, the PFS (2) is held in a first locked axial and lateral position, and the lateral position locking means relates to a means for preventing the PFS from moving or being moved laterally away from and out of alignment with the central longitudinal axis (21). As shown in FIG. 1, the elongated body (17) of the automatic inserter comprises, along a longitudinal axis (21) of the inserter body (17), a first gripping member (26) and a second gripping member (27) spaced apart from the first gripping member (26) and located on or projecting outwardly from an outwardly facing surface (28) of the inserter body (17). The first gripping member (26) and the second gripping member (27) are each shaped and configured to facilitate a user's grip of the inserter (1). The distance between the first gripping member (26) and the second gripping member (27) is configured to allow one or more fingers to be comfortably placed against the outwardly facing surface (29) of the first gripping member (26) and / or the second gripping member (27) during use of the inserter (1). Complementary to the first and second gripping members (26, 27), an area or region of increased gripping (30) is located on the outwardly facing surface (28) of the inserter body (17), e.g., at 90° or 180° about the longitudinal axis (21) relative to the gripping members (26, 27). The area of ​​increased gripping (30) is made of soft molded elastane material, a material known per se. The proximal end (18) of the elongated inserter body (17) may be suitably provided by a series of suitably shaped ridges (31) and troughs (32) suitably molded from an elastane material. As can also be seen in FIG. 1, the elongated inserter body (17) has at least one or more cut-out portions (33a, 33b) that define openings (34a, 34b) in the elongated inserter body (17) adjacent or proximate 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 view and / or access some of the components of the inserter and / or PFS (2) located within the bore (20) and also provide user access and visibility to 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.

[0051] The automatic inserter (1) further includes a needle cap holder (35) connected to the distal end (19) of the inserter body (17) via a rotatable joint (36). The needle cap holder (35) is configured such that when the PFS (2) is received in the automatic inserter body (17) prior to an injection, rotation of the joint (36) about the axis of rotation (37) of the joint (36) moves the needle cap holder (35) from a first closed position in which the needle cap holder (35) receives a needle cap or needle guard (16) removably attached to the injection needle (14) of the PFS (2) to a second open position in which the needle cap holder (35) is connected to the automatic inserter holder body (17) via the rotatable connection (36) while holding the needle cap (16) in a position removed from the PFS (2). The rotatable joint (36) can be, for example, a simple hinge or a pivot or pin and hole mechanism, such as commonly found in watch straps. Thus, the needle cap holder (35) is typically movable from a closed position, for example when the inserter (1) is not in use or while the PFS (2) is being introduced into the inserter body (17), to an open position in which the needle cap holder (35) no longer closes the opening (19a) at the distal end (19) of the inserter body (17). The cap holder (35) is moved by rotating the joint (36) about its axis of rotation (37). When in the closed position, the needle cap holder (35) receives and holds the needle (13) attached to the pre-filled syringe (2) or the needle cap (16) attached to the distal end (14) of the inserted cannula. Such needle caps (16) are commonly found to be used with pre-filled syringes to protect the user from accidental needle pricks. The needle cap holder (35) holds the needle cap (16) in the first closed position so that when the cap holder (35) is moved to the second open position, it temporarily removes the needle cap (16) to a position away from or removed from the pre-filled syringe (2) while remaining connected to the inserter holder body (17) via the rotatable joint (36).This is in contrast to known needle cap removers, which are configured to receive and remove the needle cap prior to injection, but such known needle cap removers are generally separate from the pre-filled syringe system and suffer from the disadvantage that the needle cap may be lost, misplaced, or incorrectly replaced when needed again, thereby leading to potential damage from an exposed needle after injection.

[0052] As can be seen, the rotatable joint (36) has a rotation axis (37) perpendicular to the central longitudinal axis (21) of the inserter body (17). In such a configuration, the needle cap holder (35) can rotate away from the inserter body (17) holding the pre-filled syringe (2) and back towards the pre-filled syringe (2) without interfering with the operation of preparing and performing an injection. Thus, the articulated needle cap holder (35) can be moved from the second open position back to the first closed position via rotation of the cap holder (35) about the rotation axis (36) of the joint (37) after the injection is completed, thereby replacing the needle cap (16) on the distal end opening (14) of the injection needle (13) of the pre-filled syringe (2).

[0053] The articulating needle cap holder (35) also advantageously comprises a resiliently deformable frictional gripping surface (38) configured to engage and grip the outer surface (39) of the needle cap (16). For example, the frictional gripping surface (38) comprises an elastomer. The elastomer is readily selected from a known list of available elastomers known to provide sufficient frictional gripping and abutting contact with the outer surface (39) of the needle cap (16). The frictional gripping surface (38) may be provided via a series of generally V-shaped or open conical projections (40) extending from a surface (41) of the needle cap holder (35) that faces inwardly toward the distal opening (19a) of the bore (20) of the inserter body (17). Needle cap holder (35) also includes a body (42) advantageously made of the same elastomer as frictional gripping surface (38), which forms a generally disk-shaped or circular obscurator to cover inserter body bore opening (19a) located at the distal end (19) of inserter body (17). A set of V-shaped or inverted conical projections (40) are configured to encase and frictionally engage the generally conical outer surface (39) of needle cap (16), such that the conical nose of needle cap (16) is received and encased by the corresponding conical or V-shaped projections (40) of needle cap holder (35).

[0054] The inserter body includes at least one inwardly projecting member (43) located within the bore (20) of the inserter body (17). The inwardly projecting member (43) may be suitably located at a distal location within the bore (20) of the inserter body (17), for example, projecting into the bore (20) from a sidewall of the bore (20), substantially perpendicular to the longitudinal axis of the inserter body (17), or from other components located within the bore (20) as described in more detail herein. The inwardly projecting member (43) is dimensioned and configured to provide an engagement surface (44) with which the needle cap holder (35) may engage, for example, to ensure that the cap holder (35) is held against the bore opening (19a) when the cap holder (35) is in the first closed position. In the first closed position of the needle cap holder (35), the protruding member (43) engages with a resiliently deformable frictional gripping member (45) configured to resiliently deform and releasably engage around the inner protruding member (43) located in the bore (20) of the inserter body (17), as shown in FIG. 2. It should be understood that in the second open position, the frictional gripping member (45) of the needle cap holder (35) does not have any abutting contact with the inner protruding member (43). Thus, such inner protruding member (43) is free to move or even remain in its original position as required and / or necessary. The inner protruding member (43) is advantageously attached to or extends from a movable member (46) coaxially arranged in the bore of the inserter body (17). In such a configuration, the inner projecting member (43) is therefore available to the frictional grip member (45) of the needle cap holder (35) only at the particular position of the movable member (46) to which it is provided. Figure 2 shows what such a projecting member (43) might look like, in that it is an orthogonal spur extending outwardly from a distal end (47) of an axially movable syringe body (3) holder (46) that is coaxially disposed within the bore (20) of the elongated inserter body (17).2, the elastically deformable frictional gripping member (45) is formed as an extension (48) of the body (42) of the articulating needle cap holder (35), the frictional gripping member extension (48) protruding parallel to the central longitudinal axis into the bore (20) of the inserter body (17) when the needle cap holder (35) is in the first closed position. The extension (48) has at its proximal end at least a pair of elastically deformable arms (49a, 49b) extending proximally from the frictional gripping member extension (48), each arm (49a, 49b) engaging a respective side surface (44a, 44b) of the orthogonally disposed protruding member (43). As described above, in the first position, the articulating needle cap holder (35) completely covers the distal opening (19a) of the inserter body bore (20), and correspondingly, when the articulating needle cap holder (35) is in the second position, the distal opening (19a) of the inserter body bore is unobstructed by the cap holder (35) and is completely open for the injection operation to be prepared and performed.

[0055] 2, the automated inserter (1) also includes a slidable syringe body carriage assembly (50) coaxially disposed about the central longitudinal axis (21) within the bore (20) of the elongated inserter body (17). The slidable syringe body carriage assembly (50) is configured to receive and at least partially surround a syringe body via the syringe body holder (46). The slidable carriage assembly (50) includes a translation system configured to translate the slidable carriage assembly (50) and the syringe body (3) received therein along the central longitudinal axis (21) of the inserter body bore (20) from at least a first axial position to at least a second axial position axially spaced from the first position.

[0056] The slidable carriage assembly (50) is designed and configured to at least partially surround the syringe body (3), but is also adapted to move the syringe body (3) within and along the longitudinal axis (21) of the bore of the inserter body (17) such that the syringe body (3) of the pre-filled syringe (2) may be easily positioned at several key positions along with the desired and intended function of the automatic inserter (1). For example, there are at least two primary positions to which it may be desirable to move the slidable carriage assembly (50) holding the syringe body (3) of the pre-filled syringe. The first such position is, for example, a loading position, which allows the pre-filled syringe (2) to be positioned at a position within the bore (20) of the inserter body (17) and accelerated via a suitably organized translation mechanism, such as, for example, a spring-loaded detent. A second such position is, for example, an injection-ready position to which the pre-filled syringe (2) would have been moved, appropriately speaking, in preparation for an injection step, i.e., a step in which the plunger of the pre-filled syringe is manipulated to expel the product from the chamber (4) into any part of the body that is the intended target area for administration. Other suitable or advantageous positions for the slidable carriage assembly are also possible and will be discussed in further detail herein.

[0057] The slidable syringe body carriage assembly (50) comprises a first axially movable cylinder (51), shown in Figure 2 as an outer slider body (51) coaxially located within the inserter bore (20), and a second axially movable cylinder (46), shown in Figure 2 as an inner slider body (46) or syringe holder body (46), coaxially located within the inserter bore (20) and also coaxially located within the bore of the outer slider body (51). The outer and inner slider bodies (51, 46) are axially movable along the central longitudinal axis (21) of the inserter body (17), the latter within the former, together or independently of each other, as necessary, to move one or the other of the axially movable cylinders to one or more positions relevant to use of the inserter (1).

[0058] A first axially movable cylinder, or outer slider body (51), extends from a proximal end (52) located in a proximal region of the bore (20) toward a distal end (53) and has a proximal opening (54) and a distal opening (55) forming a longitudinal bore (56). Near the distal end (53), the outer slider body has a first shoulder (57) extending radially outward. Near the proximal end (52), the outer slider body (51) also has an elastically deformable arm (58) that extends radially outward from the cylinder body and terminates in a proximal hook (59), the function of which will be described further herein. A biasing spring (60) is disposed about an outwardly facing surface (61) of the outer slider body (51) between the radially outwardly extending shoulder (57) and the resiliently deformable arm (58), the biasing spring (60) engaging the radially outwardly extending shoulder (57) at a distal end (62) of the spring (60). A lever arm safety lock (63) is provided on the outer slider body (51) proximal to the radially outwardly extending shoulder (57), 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) extending from a fulcrum pivot point (65) attached to a hinge bar (66) which forms an axis of rotation similar to an elbow about which the arm (64) pivots under the urging force of a biasing spring (67) from a first unlocked position to a second locked position, and conversely from the second unlocked position to the first unlocked position under the urging force of a contact spigot (68) extending axially from the needle cap holder (35) into the bore (56). When the needle cap holder is in the first closed position and the outer cylinder is in the rest position, the contact spigot (68) engages and contacts a shoulder (69) extending from the distal end (70) of the distal arm (64b) generally perpendicular to the longitudinal axis (21). The proximal force of the spigot (68) against the shoulder (69) is transmitted to the distal arm locking member (64b) and causes the entire arm (64) to pivot about the fulcrum (65), thereby biasing the proximal arm locking member against the biasing spring (67). This is the unlocked position of the lever arm safety lock.The biasing force of the biasing spring (67) is selected not to be strong enough to overcome the lever force exerted about the fulcrum due to contact between the spigot (68) and the shoulder (69). However, when the contact between the spigot (68) and the shoulder (69) is removed, e.g., when the needle cap holder is removed, the biasing spring (67) no longer encounters resistance and tends to bias the proximal arm locking member (64b) toward the center of the bore (56) and toward the first locked position, as described further herein. The outer slider body (51) also has at least one radially inwardly projecting shoulder (71) located proximal to the lever arm safety lock, against which another biasing spring (72) seats at its distal end (73). The outer slider inner biasing spring (72) also is in compressive or biasing contact with the inner slider or syringe holder body (46), which will be described in further detail herein. Finally, the outer slider body (51) extends distally from the outer edge (74) of a radially outwardly extending shoulder (57) to a distal end (53) that abuts a distal face (75) of the inserter body (17) to prevent movement of the outer cylinder (51) beyond the distal end (19) of the inserter body (17).

[0059] As shown in Figures 2 and 3, Figure 3 is a cross-sectional view of Figure 1, i.e., a cut-away view of the automatic inserter of Figure 1, in which the inner slider body or syringe body holder (46) is coaxially disposed within the outer slider body (51). The inner slider 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 dimensioned to receive and engage a corresponding outwardly facing surface of the syringe body (3). Distal movement of the inner slider body (46) is limited by an inner biasing spring (72) of the outer slider body (51), on which the inner slider body (46) rests in an initial rest position, as shown in Figure 2. The inner slider body (46) includes a radially outwardly extending shoulder (82) and a peripheral annular wall (83) extending proximally from an outer edge (84) of the shoulder (82). The peripheral annular wall (83) and the tubular cylinder (76) define an annular space (85) extending parallel to the longitudinal axis from the proximal end (77) of the inner slider body (46) to the radially outwardly extending shoulder (82). The annular space (85) contains a sliding caliper (86) having a first leg (87a) and a diametrically opposed second leg (87b), each caliper leg having an outwardly longitudinally oriented groove (88a, 88b) extending along the length of the leg (87a, 87b), each groove containing a corresponding biasing spring (89a, 89b) 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 their respective proximal ends (91a, 91b) of their respective legs (87a, 87b) to a cylindrical caliper body (92) dimensioned to slide along the longitudinal axis (21) within the annular space (85). The legs (87a, 87b) of the caliper (86) extend from their proximal ends (90a, 90b) through a pair of openings (93a, 93b) in a radially outwardly extending shoulder of the inner slider (46), into the bore (56) of the outer slider (51), and thus outwardly parallel to the tubular body (76) of the inner slider (46).Thus, biasing springs (89a, 89b) are located at the bottom of annular space (85) between respective openings (93a, 93b) in radially extending shoulder (82) and peripheral annular wall (86) and are received within respective grooves (88a, 88b) in caliper legs (87a, 87b). Biasing springs (88a, 88b) also engage and are restrained or compressed by distally facing surfaces (94) of proximally disposed radially inwardly extending shoulders (95) that extend radially inwardly from cylindrical caliper body (92) into inserter body bore (20). Proximal end (96) of cylindrical caliper body (92) also includes a pair of diametrically opposed outwardly projecting spars (97a, 97b) shaped and configured to receive plunger shaft support collar (99) and serve as an axis of rotation (98) thereabout. The support collar (99) is rotatably or pivotally mounted at its distal end (100) on the caliper body (92) via spars (97a, 97b) that pass through a corresponding pair of support collar legs (100a, 100b), each having a transverse opening (101a, 101b) at the distal end (102a, 102b) of each leg (100a, 100b), and provide its axis of rotation (98). Each support collar leg (100a, 100b) extends proximally from its distal end (102a, 102b) to a proximal cross bar (103) that connects the legs (100a, 100b) to one another at the proximal end (104) of the support collar (99). The cross bar (103) includes a curved or arcuate cradle (105) at approximately its center, centered about the bore (20), and shaped and dimensioned to contact, abut and support or receive and engage the outer surface of the plunger shaft (6) when the PFS (2) is introduced into the automatic inserter (1) and during operation of the automatic inserter (1). The arcuate cradle (105) of the support collar (99) is shaped to permit the plunger shaft (6) to slide axially in both distal and proximal directions within the cradle (105) in response to relative movement imparted by other moveable components of the automatic inserter (1), as described in more detail herein.Additionally, the support collar (99) is configured to be movable from a folded state in a generally horizontal position, located in a plane perpendicular to the central longitudinal axis (21), to an unfolded state in a generally vertical position, aligned parallel to the central longitudinal axis, and vice versa, and back to the folded state. The support collar (99) serves several purposes, for example, providing a proximal contact surface (106) for the proximal end (107) of the plunger shaft (6) when an injection is being performed. During distal axial movement of the inner and outer sliders (46, 51), e.g., during an injection, contact between the proximal end (107) of the plunger shaft (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 damage to the overall integrity of the inserter. As will be appreciated from the above, the support collar (99) is connected to the caliper (92) such that the caliper can slide or translate axially within the annular space (85) of the inner slider body (46), with the caliper legs (87a, 87b) extending distally through the openings (93a, 93b) as the caliper moves axially.

[0060] As shown in the plan views of Figures 2, 3 and 4, the syringe plunger locking plate (108) is connected to the legs (100a, 100b) of the support collar (99) via a pair of diametrically opposed spigots (109a, 109b) extending outwardly from respective opposing sides (110a, 110b) of the plunger locking plate (108). Each spigot (109a, 109b) engages a correspondingly sized longitudinal slot (111a, 111b) in the legs (100a, 100b) of the support collar (99). The locking plate spigots (109a, 109b) are dimensioned to slide along and be guided by the slots (111a, 111b). The locking plate is movable from a first unlocked position to a second locked position. In the unlocked position, the locking plate (108) is released from the syringe body (6) and the syringe plunger shaft (6), and in the locked position, the locking plate engages both the syringe body (3) and the syringe plunger shaft (6), thereby preventing axial movement of the syringe body (3) and the plunger shaft (6) relative to the locking plate. The locking plate (108) is disposed perpendicular to the central longitudinal axis (21) and moves perpendicular or transverse to the central longitudinal axis when a user pushes the plate (108) from the exposed or open portion (34a, 34b) of the inserter body (17), which is an opening located in the proximal constriction (24) of the inserter body (17). The locking plate (108) is configured to engage the proximal end (77) of the inner slider body (46). To this end, the locking plate (108) is provided with a pair of parallel, spaced apart, opposing L-shaped projections (113a, 113b) on its distally facing surface (112), which projections define a pair of opposing grooves (114a, 114b) that extend along respective sides (110a, 110b) along the distally facing surface (112) and perpendicular to the central longitudinal axis (21).The projections (113a, 113b) forming the locking plate grooves (114a, 114b) are sized to engage the diameter and dimensions of the proximal end (77) of the inner slider body (46) as the locking plate (108) moves laterally from the unlocked position to the locked position. The grooves (113a, 113b) formed by the L-shaped projections (113a, 113b) engage and surround the proximal lip or flange (115) on both the proximal facing surface (116) and the distal facing surface (117) of the lip (115) that extends around the proximal end (77) of the inner slider (46). The distal facing surface (112) of the locking plate is further provided with at least one pair, and preferably two pairs of abutment stops (118a, 118b, 118c, 118d) extending from the L-shaped projections. The abutment stops (118a, 118b, 118c, 118d) are configured, positioned, and dimensioned to engage and abut corresponding counter stops (119a, 119b, 119c, 119d) on the distally facing surface (117) of the flange (115) of the proximal end (77) of the inner slider body (46). The stops and counter stops prevent the locking plate from moving laterally excessively and also provide audible feedback to the user when the locking plate (108) has been moved to the correct locked position, thereby securing the proximal end (77) of the syringe body (3) within the inner slider body (46). The locking plate further includes an essentially circular opening (120) that traverses the thickness of the locking plate and is dimensioned to allow the introduction of the syringe body (3) and the plunger shaft (6) of the PFS (2) into the automatic inserter bore (20) in the unlocked position. A secondary opening (121) sized to correspond to the diameter of the plunger shaft (6) is provided adjacent the locking plate opening (120) to form a continuous union intersection such that when the locking plate is moved laterally from the unlocked position to the locked position, the opening (120) is moved laterally and the smaller secondary opening (121) is moved into the locked position to engage the outer diameter of the plunger shaft (6).Thus, the locking plate (108) serves several purposes, one of which is to lock the plunger shaft (6) in a locked position against lateral movement away from the central longitudinal axis (21) relative to the locking plate (108) and also to prevent undesired axial movement of the syringe body relative to other axially movable components of the inserter (1). Furthermore, when the locking plate is moved from the unlocked position to the locked position, the spigots (109a, 109b) move within the guide slots (111a, 111b) of the support collar legs (100a, 100b). The support collar legs (111a, 111b) are attached to the caliper spur (97) via the distal openings (101a, 101b) of their respective distal ends (102a, 102b) and thus to the fixed point axis of rotation (98). Thus, as the locking plate is moved laterally from the unlocked position to the locked position and the locking plate spigots slidingly engage the leg slots (111 a, 111 b), the plunger support collar (99) rotates about axis (98) from a folded position in which the collar (99) is substantially horizontal to a deployed position in which the collar (99) is substantially vertical, thereby bringing the collar cradle (105) into engagement and contact with the plunger shaft (6). A general representation of this condition is provided by the perspective view of the automatic inserter including a locked PFS (2) as shown in FIG. 5.

[0061] With respect to the introduction of the PFS (2) into the automated inserter (1) and the movement of the PFS (2) to an initial or resting position, a brief description of the operation of the device is provided with reference to Figures 6A and 6B. The PFS (2) is introduced into the inserter needle end first through the open proximal end (18) of the inserter body (17) and through the opening (120) in the locking plate (108) in the unlocked position, into the bore of the tubular body (76) of the inner slider body (46). The tubular body (76) receives and engages the outer surface of the syringe body (3). The syringe body is prevented from being inserted too far distally into the tubular body (76) of the inner slider body due to the general dimensions of the tubular body, which are designed and configured to mate with the outer diameter of the syringe body (3), but is also prevented from being inserted too far distally due to a proximal seat (122) formed by a radially inwardly extending shoulder (123) at the proximal end of the tubular body (76). The seat (122) also serves to locate and center the syringe body (3) within the bore of the tubular body of the inner slider body (46). Here, the locking plate (108) is moved laterally by the user, for example by pushing with the thumb, from right to left at a right angle to the longitudinal axis (21) of the inserter (1). Movement of the locking plate (108) thereby causes the L-shaped projections (113a, 113b) and corresponding locking grooves (114a, 114b) to engage and surround the proximal facing surface (116) and distal facing surface (117) of the proximal flange or lip (115) of the inner slider body (46). When the locking plate reaches 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 distal facing surface of the proximal end of the inner slider body (46). Additionally, as the locking plate is moved laterally from the unlocked position to the locked position, the support collar (99) is moved from a horizontal, folded position to a vertical, deployed position in which the support collar (99) cradles engage with the plunger shaft (6).Similarly, lateral movement of locking plate (108) causes locking plate opening (120) to move laterally and centrally align auxiliary opening (121) into engaging contact with plunger shaft (6). In the locked position of locking plate (108), syringe body (3) is held between seat (122) distal to syringe finger flange (15) and a distal face of locking plate (108) proximal to syringe finger flange (15) and is therefore unable to move axially independent of the other axially movable components.

[0062] FIG. 7A shows a partially cutaway enlarged perspective view of various details of the locking plate (108) in a locked position relative to the support collar (99), plunger shaft (6) and syringe body (3) of the PFS (2), which are located in an initial resting position. Similarly, FIG. 7B shows an enlarged bottom plan view along the central longitudinal axis (21) showing the relative details of the abutment stops (118a, 118b, 118c, 118d) and counter stops (119a, 119b, 119c, 119d) as the locking plate (108) is moved from the unlocked position to the locked position. As can be seen in FIG. 7B, the locking plate abutment stops (118a, 118b, 118c, 118d) extend from the L-shaped projections (113a, 113b). As the locking plate moves from the unlocked position to the locked position (from left to right in FIG. 7B), the abutment stops (118a, 118b) move into abutment with the counter stops (119a, 119b). As the user continues to apply lateral pressure to the locking plate, the abutment stops (118a, 118b) are forced past the counter stops (119a, 119b) until the abutment stops (118c, 118d) encounter the counter stops (119c, 119d). At this point, an audible click is generated as the abutment stops (118c, 118d) snap into place between the counter stops (119c, 119d). The locking plate (108) is considered to be in the locked position.

[0063] FIG. 8 shows an exploded perspective view of the automatic inserter (1) without a pre-filled syringe, with the various components of the inserter disposed along or on either side of the central longitudinal axis (21). For convenience, similar elements are identified with the same numbers as in FIGS. 1-4, with the following additional components indicated: From FIG. 6, it can be seen that the inner slider body (46) has a position signal element housing (124) for receiving a position signal element (125), the position signal element housing being located protruding from an outwardly facing surface (126) of the slider body (46), distal to the radially outwardly extending shoulder (82), and at a 90° angle about the central longitudinal axis (21) with respect to the openings (93a, 93b) in the radially outwardly extending shoulder (82). The position signal element (125) disposed within the position signal element housing (124) may be any suitable signal element that, when used in combination with the position sensor (127), allows the position of the inner slide body (46) relative to the component in which the position sensor (127) is housed to be communicated or determined or calculated. In this example, the position signal element (125) is usefully a permanent or inducible NS dipole magnet, e.g., a disk or bar magnet with a single NS dipole. The position sensor (127) is correspondingly advantageously a magnetometer, although it should be noted that other known combinations of position signal element and position sensor can be used to similar effect. The position sensor (127) is housed on a microelectronic circuit board (129), e.g., a printed circuit including a microcontroller with an embedded processing unit, electrically or otherwise functionally connected to the position sensor (127). For example, in FIG. 8, the position sensor (127) is suitably contained within a microelectronic printed circuit board (129) located within a position sensor housing (128) provided in the distal portion of the automatic inserter body (17).For example, Figures 2, 6A, 6B, and 9 show in enlarged detail the relative positions of the position signal element (125) and the position sensor (127) with a nominal centerline (130) extending orthogonally through the position signal element (125) that is believed to represent position point 0, i.e., the initial rest position when the PFS (2) is introduced into the automated inserter (1) and locked in the locked position. Any change in the recorded magnetic field or magnetic vector value detected or determined by the sensor (127) from the position signal element (125) indicates axial movement of the inner slider body (46), and, if the outer slider body (51) is axially displaced and locked with the inner slider body (46), indicates axial movement of the outer slider body (51).

[0064] 10A, 10B, 11A, and 11B are perspective and cross-sectional views of the automated inserter (1) and comparative representations of the relative positions of the PFS (2), plunger support collar (99), and plunger shaft (6) as it moves from an initial rest position or position 0 to a first armed position. For example, in FIGS. 10B and 11B, it can be seen that the support collar (99) in the armed position has moved proximally well past the proximal end (18) of the inserter body (17). The armed position is a position at which the pre-filled syringe (2) is moved proximally to arm the pre-filled syringe (2) for subsequent axial acceleration in a distal direction prior to the injection stroke. The armed position is a position in which the automatic inserter (1) prepositions the pre-filled syringe (2) and its associated attached needle (13) and is rapidly moved or accelerated from a proximally located armed position to a distally located axial position closer to the intended target or site of administration for the injection. The inserter (1) is called an automatic inserter because the actuation of the inserter (1) to move it from the armed position to a distal position ready for injection is equivalent to pulling the trigger of, for example, a firearm, and typically includes a stored energy source or detent, for example, using a biasing element such as a coil spring as shown in the figure. When the stored energy, i.e., spring, is released, typically by actuating a trigger mechanism, the released energy is directed in the direction in which the pre-filled syringe and needle are accelerated, allowing the needle to penetrate the site of administration, whether skin, muscle, or some other target. Of course, the purpose of the automatic inserter (1) is to provide only enough directed energy to provide such depth of penetration without forcing the needle too deeply, which may cause pain and may dissuade the user from reusing the device for subsequent injections. Those skilled in the art are capable of providing and designing such energy storage and directing mechanisms, which are per se well known in the art, for example in injection pen systems commercially available for the treatment of diabetes and other diseases.

[0065] To move the automatic inserter (1) from its initial rest position, the user moves the distal end (53) of the outer slider body (51) in a proximal direction, e.g., by pulling or pushing. The distal end (53) of the outer slider body (51) is exposed through the distal opening (34b) of the inserter body (17) and is therefore accessible for manipulation by the user. In FIG. 11A, for example, it can be seen that the position indication element (125) is aligned with the position sensor element (127). As the user moves the outer slider body (51) in a proximal direction, the outer needle cap surface (39) of the needle cap holder (35) is simultaneously captured by the cap holder friction grip surface (38), thereby forcing the inwardly facing surface (41) of the needle cap holder (35) to grip the needle cap (16). The needle cap 16 is held by the needle cap holder 35 as the outer slider body 51 moves proximally because the radially inwardly projecting shoulder 71 of the outer slider body 51 compresses the inner biasing spring 72 of the outer slider body 51, which in turn biases proximally against the radially outwardly extending shoulder 82 of the inner slider body 46. As a result of this series of biasing actions, both the outer slider body 51 and the inner slider body 46 are biased proximally, and the PFS 2 also moves in the same direction because it is secured in a locked position by the proximal seat 122 of the tubular body 76 of the inner slider body 46 and the locking plate 108. Thus, the locking plate 108 also moves proximally together with the support collar 99 and the outer and inner slider bodies 51, 46. The total proximal travel of the outer body from the initial rest position is approximately 20 mm. As the outer slider body (51) moves proximally, the elastically deformable arm (58) moves axially proximally to the same extent. When the arm starts to reach the maximum allowable proximal travel of the outer slider body, the elastically deformable arm (58) presses against the inclined segment (131, FIG. 11B) with a hook-shaped proximal end (132) of the inserter body (17), which protrudes into the inserter body bore (20).The elastic deformation of the arm (58) is configured to allow the arm (58) to overcome the resistance provided by the angled segment and the hooked proximal end (132), at which point the elastically deformable arm (58) springs outward toward the inserter body (17) and the proximal end hook (59) of the deformable arm engages with the hooked proximal end (132) of the inserter body (17), preventing the outer slider body (51) from being biased in a distal direction until the inserter is actuated to move the device from the armed position to the injection-ready position. In the armed position, the position signal element (125) is at the greatest distance from the position sensor (127) and therefore the signal generated, if the signal element is, for example, a magnet, is the weakest. Thus, the microelectronic circuit can identify that the automatic inserter (1) has been moved to the armed position.

[0066] Release of the automatic inserter (1) can be accomplished via a resiliently deformable release button (133) advantageously located near the proximal end (18) of the inserter body (17) and housed therein. The resiliently deformable release button (133) extends through the wall of the inserter body and includes a protruding biasing spur (134) that is aligned with the distal hook (59) of the resiliently deformable arm (58). When release is desired from the armed position to the ready-to-fire position, the user presses the release button (133), which causes the protruding spur (134) to resiliently deform inwardly, moving inward into biasing contact with the distal hook (59), pushing the distal hook (59) out and deforming the resiliently deformable arm such that the distal hook (59) loses contact with the hook-like proximal end (132) of the angled segment (131). In this state, the energy stored by the outer biasing spring (60) which is biased and compressed in the outer slider body (51) urges the outer slider body (51), inner slider body (46), locking plate (108), support collar (99), and PFS (2) distally toward the ready-to-inject position.

[0067] In this regard, Figure 12 shows an enlarged, partially cut away view of the relative positions of the resiliently deformable arm (58) and terminal hook (59), the angled segment (131) and hooked proximal end (132), the resiliently deformable release button (133) and the protruding spur (134). Figure 13 shows in enlargement how the needle cap (16) moves away from the distal needle end (14) as the outer slider body (51) moves proximally, showing that protection against accidental injection is still provided by the presence of the needle cap holder (35) holding the needle cap (16).

[0068] Figures 14A and 14B show the relative positions of the components of the inserter (1) between release from the armed position and the ready-to-inject position. To prepare the inserter (1) for release from the armed position, the user must first remove the needle cap holder (35) holding the needle cap (16). This is accomplished by pulling on the needle cap holder's frictional gripping surface (38), which rotates the needle cap holder about the rotatable joint (36) and corresponding axis of rotation (37) to move the needle cap holder away from the distal end (19) of the inserter body (17), as clearly shown in Figure 14B. Additionally, as the outer slider body (51) is moved proximally to the deployed position, the distal locking arm member (64b) is no longer biased by the needle cap holder (45), which in turn biases the proximal locking arm member (64a) of the lever arm safety lock (63) by the lever arm biasing spring (67) and causes the lever arm to pivot into the bore (56) and bias the proximal locking arm member (64a) against one of the caliper legs (87a). Similarly, proximal movement of the inner slider body during deployment of the inserter (1) moves the inner projection member engagement surfaces (44a, 44b) away from abutting contact with the resiliently deformable frictional gripping member (45).

[0069] As mentioned above, when the needle cap holder (35) temporarily removes the needle cap (16) from the needle (13), the inserter (1) can be moved to the ready-to-inject position. The method for achieving this is described in detail above. It is noted that when the release button (133) is pressed, the biasing force released from the accumulated energy store embodied by the outer biasing spring (60) can be sufficient to cause the distal end of the inner slider body to contact the distal end of the inserter body and generate an audible sound. Such a sound can thus indicate to the user that the ready-to-inject position has been reached. Alternatively, the ready-to-inject position can be detected by the position sensor (137) in relation to a signal, e.g., a magnetic vector or magnetic field strength, generated by the position signal element (135) and detected by the position sensor when the automatic inserter (1) is in the ready-to-inject position. The relative positions of the inserter components in the ready-to-inject position are shown in FIG. 15. In the ready-to-inject position, at least a distal portion of the pre-filled 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 that the needle (13) extends beyond the end of the inserter body (17) is designed to avoid undue trauma to the user and minimize the associated pain due to the depth of needle penetration at the administration site. It should be noted that the term "ready-to-inject" only means that the pre-filled syringe is in the proper position to perform an injection of the product contained within the syringe chamber (4), but does not mean that the injection has actually been performed or actuated. The syringe plunger and shaft (6) must still be depressed by the user to expel the product from the chamber to the administration site. This is performed as a subsequent action to move the slidable carriage assembly (50) and the pre-filled syringe (2) inserted therein into the ready-to-inject position.

[0070] Depression of the plunger head (5) of the plunger shaft (6) causes injection of the substance contained within the chamber (4). As the plunger head (5) moves distally to force the substance contained within the chamber through the needle (13), the plunger head (5) contacts the cradle (105) of the support collar (99), which also translates proximally due to the interaction of the slots (111a, 111b) in the support collar legs (100a, 100b) with the locking plate spigots (109a, 109b). When the plunger has completed its maximum allowable travel, i.e., when the distal plunger plug (135) attached to the distal end of the plunger shaft (6) reaches the distal bottom of the chamber (4) of the syringe body (3), the plunger head contacts the proximally facing surface (136) of the support cradle (105) preventing further distal movement of the plunger shaft (6) and plunger head (5) that could otherwise cause damage to the inner and outer slider bodies (46, 51). Figure 16 shows the relative positions of the components of the automatic inserter (1) after an injection is completed.

[0071] After the injection is completed, the inner slider body (46) is moved proximally together with the locking plate (108) to a third syringe retracted position, which corresponds to an axial position along the longitudinal axis of the inserter bore (20) where the needle no longer extends beyond the distal open end (19) of the inserter bore (20). In this configuration, if the syringe is to be discarded together with the inserter body, the third position may be the final position to which the syringe is moved, but advantageously, since the automatic inserter is also configured to be reused, the third position is merely an intermediate position intended to protect the inserter (1) and the user from accidents with a potentially exposed needle after the injection is completed. In this retracted position, the needle (13) of the PFS (2) is fully housed in the bore (20) of the inserter body (17).

[0072] Movement of the syringe and needle to the needle retracted position is accomplished as follows and is illustrated by Figures 16 and 17. The user depresses the lateral bar (103) of the support collar (99). The support collar legs (100a, 100b) are connected to the caliper (92) via diametrically opposed spars (93a, 93b), and distal movement applied to the caliper body (92) via the support collar legs (100a, 100b) in turn moves the caliper legs (87a, 87b) distally, whereupon their distal ends (137a, 137b) push against corresponding elastically deformable spars (138a, 138b) that extend obliquely distally from the outer slider body (51) and deform into the bore (56). Prior to elastic deformation, the elastically deformable spars (138a, 138b) have distal legs (139a, 139b) that abut and engage an annular seating rim (140) extending proximally from the distal end of the inner slider body (46). The interaction of the distal legs (139a, 139b) with the annular seating rim (140) prevents the inner slider body (46) and the outer slider body from moving proximally independent of one another. Distal movement of the distal ends (137a, 137b) of the caliper legs (87a, 87b) releases the retention of the inner slider body (46) against the outer slider body (51) by slidably engaging the elastically deformable spars (138a, 138b) and resiliently moving the spars out of engagement with the seating rim (140). Here, the inward biasing spring (72) of the outer slider body (51) biases the inner body (46) proximally until the seating rim (140) abuts against the distal facing surface (141) of the radially inwardly extending shoulder (71) of the outer slider body (51), a total proximal movement of the inner slider body at this point being approximately 12 mm. The biasing force of the inward biasing spring (72) may be configured to produce an audible sound as the seating rim abuts against the distal facing surface of the radially inwardly extending shoulder (71), alerting the user to the fact that the needle and syringe body have been retracted.Alternatively, movement of the inner body (46) containing the position signaling element (135) may be detected by the position sensor (137) as an intermediate position that is proximal compared to the initial rest position, distal to the armed position, and correspondingly proximal to the ready-to-inject position, and may be classified accordingly by the microcontroller and / or processing unit, such 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 and can be resealed by the needle cap, as described below.

[0073] As shown by Figures 19 and 20, a further safety means is provided in the form of a lever arm safety lock (63). As described elsewhere herein, the lever arm lock (63) has a biased proximal lever arm lock member (64a) that is normally biased against the presence of the needle cap holder (35) when the needle cap holder (35) is in the closed position and abuts against the distal lock arm member (64b). However, when the needle cap holder (35) is in the open position, as shown for example in Figure 18, the proximal arm lock member (64a) is biased by the lever arm biasing spring (67) to protrude into the bore (56) of the outer slider body (51) and engage 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 expelling the needle from the retracted position into a potentially puncture-inducing position before the needle cap holder (35) and the corresponding needle cap (16) temporarily held therein are returned to the closed position.

[0074] As shown in FIG. 19, once the needle and syringe reach the syringe retracted position, the needle cap holder (35) may be moved from the open position to a closed position via rotation about the joint (37), where it closes the distal end of the previously opened inserter body (17), thereby correspondingly returning the needle cap (16) to a position for re-installation onto the distal end (14) of the needle (13). Upon returning to the closed position, the needle cap holder (35) re-engages the distal locking arm member (64b) via the contact spigot (68), urging said arm member to rotate about the fulcrum pivot point (65), thereby moving the proximal locking arm member (64a) back towards the outer slider body (51) and unblocking any distal movement of the caliper legs (87a, 87b).

[0075] As shown in FIG. 20, it is now again possible to move the caliper legs (87a, 87b) distally, and by depressing the lateral bar (103) of the support collar (99), the inner slider body (46) and the caliper (92), together with the locking plate (108), move distally into the syringe release position. By engaging the syringe release position, the inner (46) and outer (51) sliders return to a position that allows the now empty or spent syringe to be safely removed from the inserter bore (20). In particular, the inner protruding member (43), which forms part of the inner slider member (46), is moved distally when it comes into frictional abutting contact with the elastically deformable frictional gripping member (45) of the needle cap holder (35). This position is shown in FIGS. 19 and 20, where it can be seen that the inner (46) and outer (51) slider bodies have returned to their initial rest positions. Such rest position may be detected and aligned, as appropriate, by the microelectronic circuitry using the position signal element (125) and the position sensor (127). Furthermore, to release the PFS (2) from the automatic inserter (1), the locking plate (108) is again moved laterally in a direction opposite to that used 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 slider body (46), as well as thereby moving the support collar (99) and cradle (105) from the deployed or vertical position back to the folded or horizontal position. At the same time, the auxiliary opening (121) of the locking plate is moved away from the plunger shaft (6) to the larger sized main locking plate opening (120), thereby allowing the now emptied syringe and capped needle to be safely withdrawn from the automatic inserter (1) via the proximal end (18) of the inserter body (17).

Claims

1. 1. An automatic inserter for a pre-filled injection syringe system, comprising: an elongate inserter body having a proximal end and a distal end; and a longitudinal bore extending through the elongate body from the proximal end to the distal end, the longitudinal bore having a central longitudinal axis, the elongate inserter body being dimensioned and configured to receive a pre-filled injection syringe introduced into the bore through the proximal end of the inserter body, and further configured and dimensioned to prevent the pre-filled injection syringe from exiting the longitudinal bore through the distal end; the needle cap holder is configured to be moved, via rotation of the joint about a rotation axis of the joint, from a first closed position in which the needle cap holder receives a needle cap removably attached to an injection needle of the pre-filled injection syringe when the pre-filled syringe is received in the inserter body prior to an injection, to a second open position in preparation for an injection process in which the needle cap holder remains connected to the inserter holder body via the rotatable joint and holds the needle cap in a position removed from the pre-filled injection syringe.

2. The automated inserter of claim 1 , wherein the rotatable joint has an axis of rotation perpendicular to a central longitudinal axis of the inserter body.

3. 2. The automatic inserter of claim 1, wherein the articulated needle cap holder is configured to be moved from the second position back to the first position via rotation of the cap holder about the axis of rotation of the articulation after an injection is completed, thereby repositioning the needle cap on the injection needle of the pre-filled injection syringe.

4. 10. The automatic inserter of claim 1, wherein the articulating needle cap holder comprises a resiliently deformable frictional gripping surface configured to engage and grip an exterior surface of a needle cap.

5. 4. The automatic inserter of claim 3, wherein the frictional gripping surface comprises an elastomer.

6. 6. The automatic inserter of claim 1, wherein the inserter body comprises an internal projection member disposed within the bore of the inserter body.

7. 7. The automatic inserter of claim 1, wherein the articulating needle cap holder comprises an elastically deformable frictional gripping member configured to elastically deform around and releasably engage an inner projection member disposed within the bore of the inserter body in the first closed position, and wherein in the second position, the frictional gripping member of the needle cap holder is not in abutting contact with the inner projection member.

8. 8. The automatic inserter of claim 7, wherein the elastically deformable frictional gripping member is formed as an extension of the body of the articulating needle cap holder, the extension projecting into the bore of the inserter body.

9. 9. The automatic inserter of claim 1, wherein in the first position, the articulating needle cap holder completely covers the distal opening of the inserter body bore.

10. 10. The automatic inserter of claim 1, wherein in the second position, the articulating needle cap holder holds the distal opening of the inserter body bore fully open.

11. 1. An automatic inserter for a pre-filled injection syringe system, comprising: an elongate inserter body having a proximal end and a distal end; and a longitudinal bore extending through the elongate body from the proximal end to the distal end, the longitudinal bore having a central longitudinal axis, the elongate inserter body being dimensioned and configured to receive a pre-filled injection syringe introduced into the bore through the proximal end of the inserter body, and further configured and dimensioned to prevent the pre-filled injection syringe from exiting the longitudinal bore through the distal end; the inserter body includes a slidable syringe body carriage assembly disposed within the bore configured to receive and at least partially surround the syringe body; The inserter body, wherein the slidable carriage assembly includes a translation system configured to translate the slidable carriage assembly and a syringe body received therein along a central longitudinal axis of the inserter body bore from at least a first axial position to at least a second axial position axially spaced from the first position.

12. 12. The automatic inserter of claim 1, wherein the inserter body comprises a syringe plunger locking plate.

13. 13. The automatic inserter of claim 1, wherein the syringe plunger locking plate is configured and adapted to be moved from an unlocked position to a locked position, wherein in the unlocked position, the locking plate is disengaged from the syringe plunger and in the locked position, the locking plate engages the syringe plunger to prevent axial movement of the syringe plunger relative to the locking plate.

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

15. 15. The automatic inserter of claim 13, wherein in the unlocked position, the locking plate has a first end that extends outside the inserter body, and in the locked position, the first end is fully received within the bore of the inserter body.

16. 16. The automatic inserter of claim 1, wherein the slidable syringe body carriage assembly comprises a first axially movable cylinder coaxially disposed within the inserter bore and a second axially movable cylinder coaxially disposed within the bore of the inserter bore, preferably coaxially within the bore of the first movable cylinder.

17. 17. The automatic inserter of claim 16, wherein the first axially movable cylinder and the second axially movable cylinder are configured to be moved axially within the inserter body bore independently of one another.

18. 17. The automatic inserter of claim 16, wherein the first axially movable cylinder and the second axially movable cylinder are configured to be moved axially together within the inserter body bore.

19. 12. The automatic inserter of claim 11, wherein the at least a first axial position is an initial rest position.

20. 12. The automatic inserter of claim 11, wherein the at least another axial position is a loading position in which the pre-filled syringe is moved proximally to load the pre-filled syringe for subsequent proximal axial acceleration prior to an injection step.

21. 12. The automatic inserter of claim 11, wherein the at least another axial position is a ready-to-inject position in which at least a distal portion of the pre-filled syringe extends beyond a distal end of the inserter body.

22. 22. The automatic inserter of claim 11, 12 and 17, or claim 12, 17 and 21, wherein the slidable syringe body carriage assembly comprising the first axially movable cylinder and the second axially movable cylinder are simultaneously moved proximally together with the locking plate to the armed position.

23. 23. The automatic inserter of claim 22, wherein movement of the slidable carriage assembly to the armed position retains a needle cap located at the distal end of the pre-filled syringe within the needle cap holder.

24. 21. The automatic inserter of claim 1 and claim 20, wherein when the first axially movable cylinder, the second axially movable cylinder, and the locking plate are in the armed position, the needle cap holder is moved from the first closed position to the second open position.

25. 22. The automatic inserter of claim 21, wherein the slidable syringe body carriage assembly including the first axially movable cylinder and the second axially movable cylinder are configured to be simultaneously moved distally together with the locking plate into the injection ready position.

26. 18. The automatic inserter of claim 17, wherein the second axially movable cylinder of the slidable syringe body carriage assembly is configured to be moved proximally together with the locking plate to a syringe retracted position.

27. 12. The automatic inserter of claim 11, wherein the needle cap holder is moved from the second open position to the first closed position when the second axially movable cylinder and locking plate are in the syringe retracted position.

28. 12. The automatic inserter of claim 11, wherein the second axially movable cylinder of the slidable syringe body carriage assembly is configured to be moved distally together with the locking plate to a syringe release position.

29. 13. The automatic inserter of claim 12, wherein the locking plate comprises a locking means configured to releasably engage a proximal end of the second axially movable cylinder of the slidable carriage assembly.

30. 13. The automatic inserter of claim 12, wherein the locking plate comprises a plunger shaft support collar extending proximally from the locking plate for sliding contact with at least a portion of the plunger shaft, the support collar configured to move from a folded state to an deployed state or from the deployed state to the folded state.

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