Patent Description:
Administering an injection is a process which presents a number of risks and challenges for users and healthcare professionals, both mental and physical. Injection devices typically fall into two categories - manual devices and autoinjectors. In a conventional manual device, manual force is required to drive a medicament through a needle. This is typically done by a plunger which has to be continuously pressed during the injection. There are numerous disadvantages associated with this approach. For example, if the plunger is released prematurely, the injection will stop and may not deliver an intended dose. Furthermore, the force required to push the plunger may be too high (e.g., if the user is elderly or a child). And, aligning the injection device, administering the injection, and keeping the injection device still during the injection may require dexterity which some patients may not have.

Autoinjector devices may be single-use or reusable devices and aim to make self-injection easier for patients. A conventional autoinjector may completely or partially replace activities involved in parenteral drug delivery from a manual device. Typically, such activities include removal of a protective syringe cap, insertion of the needle, providing the force for administering the injection and possibly removal and shielding of the used needle.

<CIT> discloses a medicament container carrier comprising a proximal section having a first diameter, a distal section having a second diameter less than the first diameter, and at least one resilient beam arranged in the proximal section and having a beam head protruding radially to form a third diameter. The at least one beam has a non-deflected position in which the third diameter is less than the first diameter and a deflected position in which the third diameter is substantially equal to the first diameter. <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT> and <CIT> also describe prior art supports for syringes/cartridges.

There remains a need for a syringe support within the autoinjector and an improved autoinjector comprising such a syringe support so that the autoinjector and its components, in particular a syringe, are securely arranged within a housing.

It is an object of the present invention to provide a syringe support and an improved autoinjector with such a syringe support.

The object is achieved by a syringe support according to claim <NUM> and by an autoinjector according to claim <NUM>.

Exemplary embodiments of the invention are given in the dependent claims.

One aspect of the present disclosure relates to a syringe support for supporting an axial position of a syringe relative to a housing of an autoinjector, wherein the syringe support comprises a supporting beam arranged on the syringe support and biased radially inwards, wherein the supporting beam is adapted to axially bias the syringe in a distal direction within the housing.

The syringe support provides a secure arrangement of the syringe within the housing. In particular, the syringe support allows tolerance compensation. For example, the syringe support allows that syringes with different lengths due to manufacturing tolerances may be arranged within the same housing. Furthermore, the syringe support prevents rattle of the syringe in the housing and at least reduces and prevents axial movement of the syringe which otherwise could cause the protective needle shield to be displaced relative to the syringe, potentially impacting sterility.

In an exemplary embodiment, the supporting beam is adapted to accommodate a variable length of the syringe within the housing in the distal direction. In other words, the supporting beam provides a secure arrangement by compensating different syringe lengths. In particular, the supporting beam is adapted to compensate the length of the syringe of maximum <NUM>%, in particular <NUM>%. For example, the syringe support accommodates +/-<NUM> syringe length for a syringe of <NUM> in length.

Additionally, for syringes with a smaller length, the supporting beam may damp a shock of an impact force due to falling so that the syringe is less prone to damages. For instance, due to impact forces on an end of the autoinjector, the syringe moves rearwards, a portion of the supporting beam deflects and further stresses radially outwards so that the rearward movement of the syringe can be absorbed, in particular damped and restricted.

The supporting beam is located distally on the syringe support.

Thereby, the distal supporting beam retains the syringe in position. Furthermore, more than one supporting beams may be arranged around the circumference of the syringe flange, thus the syringe is reliably held in position.

The supporting beam is formed as a flexure beam. In particular, the supporting beam is formed as a radially inward half-arc or arc enabling the supporting beam to be maintained in a relaxed position and to form a stop for the syringe for compensating different syringe length. Furthermore, the supporting beam may be stressed during assembling of the syringe due to different length of the syringe to avoid or at least minimize risk of damages. For instance, during assembling, the syringe is carried and holds by a syringe carrier at its distal end wherein the proximal end, namely the flange, of the syringe projects the proximal end of the syringe carrier so that a portion of the supporting beam, engaging the flange, deflects and further stresses radially outwards so that the length of the syringe can be compensated.

Furthermore, the supporting beam may be formed from resilient material. In particular, the resilient supporting beam could be in the form of an arc of resilient material, wherein at least one end of the arc is attached to the housing and an outer free end of the arc is in juxtaposition with the flange of the syringe.

In a further embodiment, one end of the supporting beam is attached to the syringe support and an opposite end is a free end. In particular, the supporting beam is integrated into the syringe support wherein the supporting beam extends radially inwards from a recess or aperture in the syringe support so that the supporting beam deflects radially outwards into the recess or aperture when the syringe is assembled or moves rearwards. In an alternative embodiment, both ends of the supporting beam may be attached to the syringe support, e.g. to opposite ends of the aperture in the syringe support. Such a supporting beam may be part of the syringe support and may be integrated into the aperture as a bent or arc. In particular, the supporting beam may be integrally moulded with the syringe support for ease of manufacture.

Furthermore, the syringe support may comprise a number of apertures adapted to form a corresponding number of supporting beams that interact with the flange of the syringe for providing a length compensation or a damping and a restricting of an axial movement of smaller syringes rearwards when the syringe is assembled and in place within the housing. Furthermore, the supporting beams may be arranged around the circumference of the syringe flange, thus the syringe is reliably held in position.

In a further embodiment, at least two supporting beams are arranged on the syringe support. The at least two supporting beams are arranged opposed to each other. More than two supporting beams may be provided and may be symmetrically arranged on the syringe support. Further, the at least two supporting beams are formed as flexure beams, e.g. as a radially inward bent, for instance a half-arc or arc.

In an exemplary embodiment, the at least two supporting beams have different free ends wherein one of the free ends is bent and the other free end is straight. In an assembled state of the autoinjector, the different free ends of the supporting beams laterally extend beyond the flange of the syringe. Hence, the flange of the syringe abuts the different free ends. The different free ends are adapted to provide a secure axial support and positioning of the syringe relative to the housing in the rearward direction. Thus, a risk of breakage is reduced. This increases the range of geometrical syringe lengths that can be accommodated.

According to another aspect of the disclosure, an autoinjector comprises a syringe support as described above and a housing, wherein the housing comprises such a syringe support.

In an assembled state, the supporting beam and the flange of the syringe contact one another and are pressed onto one another so that the syringe is securely positioned.

In an exemplary embodiment, the housing comprises an aperture in which the supporting beam is arranged. In particular, the supporting beam is biased radially inwards from the aperture.

In an exemplary embodiment, the housing comprises at least two rigid arms wherein each rigid arm comprises one supporting beam. In particular, the two rigid arms are formed as inner arms which inwardly extend from an outer housing part, e.g. a proximal end, into the housing.

In particular the housing comprises a front part and a rear part wherein the supporting beam is arranged on the rear part. The rear part comprises a proximal end from which the rigid arms are inwardly extended. In this way, the supporting beam is arranged on a distal end of the rear part.

Furthermore, the housing comprises a proximal end which is larger than a proximal aperture of the housing. Thereby, the proximal end of the rear part rests on the edge of the proximal aperture of the front part to proximally close the housing.

Further scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating exemplary embodiments of the invention, are given by way of illustration only, since various changes and modifications within the scope of the invention will become apparent to those skilled in the art from this detailed description.

The present invention will become more fully understood from the detailed description given herein below and the accompanying drawings which are given by way of illustration only, and thus, are not limitative of the present invention, and wherein:.

<FIG> is a schematic perspective partial section of an exemplary embodiment of an autoinjector <NUM> in a state after assembly.

The autoinjector <NUM> comprises a housing <NUM> including a sleeve shaped front part <NUM> and a rear part <NUM>.

The housing <NUM> is adapted to hold a syringe <NUM>, e.g. a glass syringe. The syringe <NUM> may be a prefilled syringe containing a liquid medicament M and have a needle <NUM> arranged on a distal end. In another exemplary embodiment, the syringe <NUM> may be a cartridge which includes the medicament M and engages a removable needle (e.g., by threads, snaps, friction, etc.). In the shown exemplary embodiment, the syringe <NUM> is held in the housing <NUM> and supported at its proximal end therein by a syringe support <NUM> further described below.

The autoinjector <NUM> further comprises a protective needle sheath <NUM> that is coupled to the needle <NUM>. For example, the protective needle sheath <NUM> is removably coupled to the needle <NUM>. The protective needle sheath <NUM> may be a rubber needle sheath or a rigid needle sheath which is composed of rubber and a full or partial plastic shell.

A stopper <NUM> is arranged for sealing the syringe <NUM> in a proximal direction P and for displacing the medicament M contained in the syringe <NUM> through the needle <NUM>.

The autoinjector <NUM> further comprises a sleeve shaped needle shroud <NUM>. In an exemplary embodiment, the needle shroud <NUM> is telescopically coupled to the housing <NUM> and movable between an extended position relative to the housing <NUM> in which the needle <NUM> is covered and a retracted position relative to the housing <NUM> in which the needle <NUM> is exposed. Furthermore, a shroud spring <NUM> is arranged to bias the needle shroud <NUM> in a distal direction D against the housing <NUM>.

A drive spring <NUM> in the shape of a compression spring is arranged within a proximal part of the housing <NUM>, in particular the rear part <NUM>. A plunger <NUM> serves for forwarding the force of the drive spring <NUM> to the stopper <NUM>. In an exemplary embodiment, the plunger <NUM> is hollow and the drive spring <NUM> is arranged within the plunger <NUM>, biasing the plunger <NUM> in the distal direction D against the rear part <NUM>. In another exemplary embodiment, the plunger <NUM> may be solid and the drive <NUM> may engage a proximal end of the plunger <NUM>. Likewise, the drive spring <NUM> could be wrapped around the outer diameter of the plunger <NUM> and extend within the syringe <NUM>.

Furthermore, the autoinjector <NUM> comprises a cap <NUM> that may be removably disposed at a distal end of the housing <NUM>, in particular at a distal end of the front part <NUM>. The cap <NUM> may comprise grip features <NUM> for facilitating removal of the cap <NUM>, e.g., by twisting and/or pulling the cap <NUM> off the case <NUM>. The cap <NUM> may further include a grip element <NUM>, e.g., a barb, a hook, a narrowed section, etc., arranged to engage the protective needle sheath <NUM>, the housing <NUM> and/or the needle shroud <NUM>. For example, the protective needle sheath <NUM> is coupled to the cap <NUM> in a manner that when the cap <NUM> is removed, the protective needle sheath <NUM> is also removed from the needle <NUM>.

A plunger release mechanism <NUM> is arranged for preventing release of the plunger <NUM> prior to depression of the needle shroud <NUM> and for releasing the plunger <NUM> once the needle shroud <NUM> is sufficiently depressed.

In an exemplary embodiment, the autoinjector <NUM> further comprises at least one audible indicator <NUM> for producing an audible feedback for a user or patient indicating that medicament delivery is complete. In other words: The audible indicator <NUM> is adapted to indicate to a user or a patient that the full dose of medicament M was spent. The audible indicator <NUM> is formed for example as a bistable spring and is held in the rear part <NUM>.

To allow an accurate support of the syringe <NUM> during and after assembly, the autoinjector <NUM> comprises a carrier <NUM> adapted to mount and hold the syringe <NUM> within the housing <NUM> in a forward or distal direction D.

A shroud pre-lock mechanism <NUM> is arranged to prevent depression of the needle shroud <NUM> when the cap <NUM> is in place, thus avoiding unintentional activation of the autoinjector <NUM>, e.g. if dropped, during shipping or packaging, etc..

Due to manufacturing tolerance, syringes <NUM> may have variable lengths L. Thus, a flange <NUM> of the syringe <NUM> protrudes the carrier <NUM> in the proximal direction P. To support the axial position of the syringe <NUM> relative to the housing <NUM> after assembly, in particular during storage, transportation and normal use, the syringe support <NUM> comprises one or more supporting beams <NUM> biased radially inwards to accommodate the variable length L of the syringe <NUM> in an assembled state. The supporting beams <NUM> are adapted to axially bias the syringe <NUM> in the distal direction D within the housing <NUM> and to compensate the variable length L of the syringe <NUM> in the distal direction D. In particular, the syringe support <NUM> is adapted to accommodate the length L of the syringe <NUM> of maximum <NUM>% or <NUM>%. For example, the syringe support <NUM> accommodates +/-<NUM> of the length L for a syringe <NUM> of <NUM> in length L.

<FIG> are schematic views of the rear part <NUM> of the housing <NUM>. The rear part <NUM> comprises the syringe support <NUM>. The syringe support <NUM> is adapted to compensate the variable length L of the syringe <NUM>. In detail, the rear part <NUM> comprises at its front or distal end the supporting beams <NUM>. The supporting beams <NUM> are formed as resilient arms or flexure beams biased radially inwards to compensate the variable lengths L of the syringe <NUM>.

The rear part <NUM> has a proximal end <NUM>. The proximal end <NUM> of the rear part <NUM> is larger than a proximal aperture <NUM> so that the proximal end <NUM> rests on the edge of the proximal aperture <NUM> of the front part <NUM>. Two rigid arms <NUM> are extended from the proximal end <NUM> inwards in to the distal direction D.

The shown syringe support <NUM> comprises two supporting beams <NUM> and a respective number of apertures <NUM> in the rigid arms <NUM>. The apertures <NUM> are adapted to receive each of the supporting beams <NUM> when they deflect and stress radially outwards during assembling of the syringe <NUM> having a variable length L.

The supporting beams <NUM> and the corresponding apertures <NUM> are arranged on a distal end of the rear part <NUM>.

The supporting beams <NUM> may be formed from resilient material and in the form of an arc or half-arc.

One end of each supporting beams <NUM> is attached to the aperture <NUM> in the rear part <NUM>. The opposite end is a free end. Each supporting beam <NUM> extends radially inwards from the aperture <NUM> so that the supporting beam <NUM> deflects radially outwards into the aperture <NUM> when a syringe <NUM> with a respective length L is assembled into the syringe carrier <NUM> and the flange <NUM> of the syringe <NUM> protrudes the syringe carrier <NUM> in the proximal direction P. In particular, the supporting beams <NUM> may be integrally moulded with the housing <NUM>, namely with the rear part <NUM>.

In an alternative embodiment (not shown), both ends of the supporting beam may be attached to the housing.

Furthermore, the rear part <NUM> comprises a housing lock <NUM> having a housing lock arm <NUM> to attach the rear part <NUM> onto the front part <NUM>. The housing lock arm <NUM> is arranged on a proximal section of the rear part <NUM> and is biased radially outwards.

<FIG> shows an alternative embodiment of a syringe support <NUM>' formed as a separate single part and the rear part <NUM> formed as a separate single part. The syringe support <NUM>' has a proximal support end <NUM> from which rigid support arms <NUM> comprising the supporting beams <NUM> distally protrude. The proximal support end <NUM> and the housing <NUM>, in particular the front part <NUM> or the rear part <NUM>, are correspondingly adapted to retain and hold the syringe support <NUM>' in place on the housing <NUM>, e.g. by securing a rim in a nut or in clips on the housing (shown in dotted line).

The separate rear part <NUM> only comprises the housing lock <NUM> for releasably connecting the rear part <NUM> with the front part <NUM> to form the housing <NUM>.

<FIG> is a schematic longitudinal section view of the rear part <NUM>. The <FIG> shows the rear part <NUM> with one supporting beam <NUM> that are part of the syringe support <NUM>. The supporting beam <NUM> is arranged on a distal section of the rear part <NUM> and is biased radially inwards.

The housing lock arms <NUM> attach the rear part <NUM> onto the front part <NUM>. The housing lock arms <NUM> are proximally arranged on the rear part <NUM> and are biased radially outwards. The housing lock arms <NUM> retain the rear part <NUM> in position with the front part <NUM>.

<FIG> is a schematic side view of the rear part <NUM> comprising the syringe support <NUM>. To guide the rear part <NUM> during assembling and to support it after assembling and during use, the rear part <NUM> comprises an inner stamp <NUM>. The inner stamp <NUM> further supports the assembling and arrangement of the drive spring <NUM> (see <FIG>).

<FIG> is a schematic horizontal section view of the syringe support <NUM> according to line VI-VI in <FIG>. The free ends of the supporting beams <NUM> are biased radially inwards with respect to the rigid arms <NUM>.

<FIG> is a schematic side view of the rear part <NUM> with the supporting beam <NUM> attached to the aperture <NUM> and arranged on the distal end of the rear part <NUM>. The distal end of the supporting beam <NUM> is attached to the aperture <NUM> and the proximal end of the supporting beam <NUM> is formed as a free end biased radially inwards.

<FIG> are enlarged schematic views of the syringe support <NUM> formed as part of the rear part <NUM>. The syringe support <NUM> is shown in different positions and in more detail.

<FIG> shows the syringe support <NUM> while the syringe <NUM> with a normal length L is in an assembled position.

The at least two supporting beams <NUM> have different free ends wherein one of the free ends is bent and the other free end is straight. The free ends of the arcs of the supporting beams <NUM> are in juxtaposition with the flange <NUM> of the syringe <NUM>.

Furthermore, the different free ends of the supporting beams <NUM> laterally extend beyond a flange <NUM> of the syringe <NUM>. The flange <NUM> abuts the supporting beams <NUM> and the different free ends to provide a secure axial support and positioning of the syringe <NUM> relative to the housing <NUM> in the distal direction D. Syringes <NUM> having variable lengths L may be assembled within the housing <NUM> wherein the supporting beam <NUM> is deflected radially outwards and stressed so that the variable lengths L of the syringes <NUM> can be compensated. Hence, a risk of breakage is reduced and manufacturing tolerances may be compensated.

In the shown embodiment, the supporting beams <NUM> are arranged between the flange <NUM> of the syringe <NUM> and the front part <NUM> of the housing <NUM>.

<FIG> shows further embodiments for the syringe support <NUM> with assembled syringes <NUM> of different lengths L. Hence, the syringe support <NUM> allows compensation of length tolerances of syringes <NUM> to be assembled.

<FIG> shows the front part <NUM> and the rear part <NUM> of the housing. The front part <NUM> and the rear part <NUM> are correspondingly adapted to couple with each other, e.g. by means of a releasable connection formed by e.g. the housing locking arms <NUM> and corresponding slots <NUM>.

Exemplary insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin. Exemplary GLP-<NUM>, GLP-<NUM> analogues and GLP-<NUM> receptor agonists are, for example: Lixisenatide / AVE0010 / ZP10 / Lyxumia, Exenatide / Exendin-<NUM> / Byetta / Bydureon / ITCA <NUM> / AC-<NUM> (a <NUM> amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide / Victoza, Semaglutide, Taspoglutide, Syncria / Albiglutide, Dulaglutide, rExendin-<NUM>, CJC-<NUM>-PC, PB-<NUM>, TTP-<NUM>, Langlenatide / HM-11260C, CM-<NUM>, GLP-<NUM> Eligen, ORMD-<NUM>, NN-<NUM>, NN-<NUM>, NN-<NUM>, Nodexen, Viador-GLP-<NUM>, CVX-<NUM>, ZYOG-<NUM>, ZYD-<NUM>, GSK-<NUM>, DA-<NUM>, MAR-<NUM>, MAR709, ZP-<NUM>, ZP-<NUM>, TT-<NUM>, BHM-<NUM>. MOD-<NUM>, CAM-<NUM>, DA-<NUM>, ARI-<NUM>, ARI-<NUM>, Exenatide-XTEN and Glucagon-Xten.

Basic salts are e.g. salts having a cation selected from an alkali or alkaline earth metal, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10-heteroaryl group.

Claim 1:
A syringe support (<NUM>, <NUM>') for supporting an axial position of a syringe (<NUM>) relative to a housing (<NUM>) of an autoinjector (<NUM>), wherein the housing (<NUM>) comprises a rear part (<NUM>) comprising a proximal end (<NUM>) and at least one rigid arm (<NUM>, <NUM>) extending in the distal direction (D) from the proximal end (<NUM>),
wherein the syringe support (<NUM>, <NUM>') comprises a supporting beam (<NUM>) arranged on a distal end of the at least one rigid arm (<NUM>, <NUM>) and biased radially inwards,
wherein the supporting beam (<NUM>) is adapted to axially bias the syringe (<NUM>) in a distal direction (D) within the housing (<NUM>),
wherein the supporting beam (<NUM>) is adapted to accommodate syringes (<NUM>) having variable lengths (L) within the housing (<NUM>) in the distal direction (D),
wherein the supporting beam (<NUM>) is configured to engage a flange (<NUM>) of the syringe (<NUM>), and
wherein the supporting beam (<NUM>) is formed as a flexure beam.