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 comprising at least one resilient beam arranged proximally and having a beam adapted to avoid proximal movement of the syringe with respect to the carrier after assembly of the syringe. The resilient beam is biased during assembly of the syringe. After that, the resilient beam is relaxed and provides a proximal abutting surface for the flange of the syringe to prevent proximal movement of the syringe.

<CIT>, <CIT>, <CIT>, and <CIT> relate to injection devices.

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 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 projecting portion which projects from the syringe support into a distal direction and a flexible portion which axially adjoins the projecting portion and which is adapted to axially bias the syringe in the distal direction within the housing.

The syringe support provides a secure arrangement of the syringe within the housing. In particular, the syringe is arranged within the housing less prone to failures and damages and allows tolerance compensation. The syringe support further ensures that the syringe is biased forward against forward stop and thereby ensures that the needle is always inserted to full insertion depth. In particular, the syringe does not move backward under force of piercing skin. Furthermore, the syringe support allows that syringes with different lengths due to manufacturing tolerances may be arranged within the same housing.

In an exemplary embodiment, the flexible portion is adapted to accommodate to syringes having different lengths. In other words, the flexible portion provides a secure arrangement by compensating different syringe lengths. In particular, the flexible portion is adapted to compensate variations in 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.

On final assembly of the syringe into a housing of an autoinjector, after the syringe has been inserted and moved to its final assembling position inside the housing, the flexible portion, also called compliant backstop, deflects axially and thus provides an axial force on the syringe to bias it forward and so prevents its axial movement during storage, transportation, drop and use.

The flexible portion is sized to accommodate the tolerances of both the syringe and the autoinjector, in particular the housing, whilst limiting the movement of the syringe during drop to prevent accidental de-booting of the syringe. The stiffness of the flexible portion is tailored to provide a minimum force required to restrain the syringe during storage, transportation, drop and use so as to not unduly stress the syringe flange and for example risk glass fracture.

In an exemplary embodiment, the flexible portion is designed in the form of a web, in the form of a flexure beam or in the form of a spring arm. Moreover, the flexible portion is of meander-shaped, accordion-shaped, labyrinth-shaped, U-shaped, V-shaped, W-shaped or S-shaped design. In particular, the flexible portion is of an accordion-shaped or labyrinth-shaped design to be maintained in a relaxed position and to form a stop for the syringe for compensating different syringe lengths. Furthermore, the flexible portion may be stressed during assembling of the syringe due to different lengths of the syringes 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 the flexible portion, engaging the flange, deflects and further stresses axially rearwards so that the length of the syringe can be compensated.

Furthermore, the flexible portion may be formed from resilient material. The flexible portion is designed to provide a reasonable compressive strength as well as bending strength. In particular, the flexible portion may be formed from a corresponding resilient material, e.g. plastic, and/or with a corresponding structural design, e.g. horizontal and vertical webs and ribs. Furthermore, the projecting portion is stronger than the flexible portion, e.g. the plastic of the projecting portion is stronger than the plastic of the flexible portion.

Moreover, the resilient flexible portion could be in the form of a multiply bent arc of resilient material, wherein at least one end of the multiply bent arc is attached to the syringe support and an outer free end of the multiply bent arc is in juxtaposition with the flange of the syringe. The flexible portion axially extends in the distal direction.

In an exemplary embodiment, the flexible portion is located distally on the syringe support. Thereby, the distal flexible portion retains the syringe in position. The distal end of the distal flexible portion is a free end. The opposite proximal end of the distal flexible portion adjoins the projecting portion. Furthermore, more than one flexible portion may be arranged around the circumference of the syringe flange, thus the syringe is reliably held in position.

Moreover, the flexible portion is integrally formed with the projecting portion so that the flexible portion deflects axially rearwards against the projecting portion when the syringe is assembled or moves rearwards. In particular, the flexible portion may be integrally moulded with the syringe support for ease of manufacture, e.g. may be produced in an injection moulding die by injection moulding from plastic.

Furthermore, the syringe support may comprise a number of projecting portions with adjoined flexible portions that interact with the flange of the syringe for providing 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 flexible portions may be arranged around the circumference of the syringe flange, thus the syringe is reliably held in position.

At least two flexible portions are arranged distally on the syringe support. The at least two flexible portions are arranged opposed to each other. More than two flexible portions may be provided and may be symmetrically arranged on the syringe support. The flexible portions 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.

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 flexible portion 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 flexible portion is distally attached to the projecting portion. In particular, the flexible portion is biased in the distal direction.

In an exemplary embodiment, the syringe support comprises at least two rigid projecting portions, e.g. rigid arms, wherein each rigid arm comprises one flexible portion. In particular, the two rigid arms are formed as inner arms which inwardly extend from a proximal 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 flexible portion 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 flexible portion is arranged on a distal end of the rigid arms.

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>. Alternatively, the housing <NUM> may be formed as a one-piece housing (not shown).

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 flexible portions <NUM> axially biased to accommodate to syringes <NUM> having different lengths L. The flexible portions <NUM> are adapted to axially bias the syringe <NUM> in the distal direction D within the housing <NUM> and to compensate the variations in 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 variations in length L of the syringe <NUM>. In detail, the syringe support <NUM> comprises two projecting portions <NUM> projecting in the distal direction D and, at its front or distal end, two flexible portions <NUM>. The flexible portions <NUM> adjoin the projecting portions <NUM> axially in the distal direction D.

The flexible portions <NUM> are integrally formed with the projecting portions <NUM>. In the shown embodiment, the projecting portions <NUM> are part of the housing <NUM>, namely of the rear part <NUM>. The projecting portions <NUM> project from a proximal end <NUM> of the housing <NUM> inwardly in the distal direction D.

In the shown embodiment, the rear part <NUM> has the 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>.

The projecting portions <NUM> of the syringe support <NUM> form part of the housing <NUM>, namely two rigid arms <NUM>, which are extended from the proximal end <NUM> inwards into the distal direction D. The flexible portions <NUM> are arranged on the distal end of the rear part <NUM>.

Furthermore, the rear part <NUM> comprises a housing lock <NUM> having two housing lock arms <NUM> to attach the rear part <NUM> to the front part <NUM>. The housing lock arms <NUM> are located proximally on the syringe support <NUM>. For secure fastening of the rear part <NUM> to the front part <NUM>, the housing lock <NUM> has an outer diameter larger than an outer diameter of the projecting portion <NUM> in a biased state.

For assembling of the rear part <NUM> to the front part <NUM>, the housing lock arms <NUM> are being deflectable inwards until they reach corresponding slots <NUM> in the front part <NUM> in which the housing lock arms <NUM> deflect outwards and latch. The housing lock arms <NUM> are arranged on a proximal section of the rear part <NUM> and are biased radially outwards.

Furthermore, the proximal end <NUM> of the rear part <NUM> forms the proximal end <NUM> of the syringe support <NUM> and has an outer diameter larger than an outer diameter of the projecting portion <NUM>.

The flexible portions <NUM> are designed as elastic spring portions. The flexible portions <NUM> have a progressive spring characteristic curve in respect of an axial deflection such that a progressively increasing spring force in the flexible portions <NUM> occurs with increasing length L of the assembled syringe <NUM>. Thus, the flexible portions <NUM> compensate variations in lengths L of the syringe <NUM> due to its axial deflection.

One end of each flexible portion <NUM> is attached to the corresponding projecting portion <NUM>. The opposite distal end is a free end. The flexible portions <NUM> may be formed from resilient material, e.g. plastic.

In the shown embodiment, the flexible portions <NUM> have a labyrinth-shaped design with at least two axially arranged chambers <NUM> connected by at least one web <NUM>. The distal end of the flexible portions <NUM> have at least two supporting ribs <NUM> which attach the flange <NUM> of the syringe <NUM> when the syringe <NUM> is assembled into the syringe carrier <NUM> and the flange <NUM> protrudes the syringe carrier <NUM> in the proximal direction P (see <FIG>).

<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 the rigid projecting portions <NUM> comprising the flexible portions <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 <NUM> (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 flexible portion <NUM> that are part of the syringe support <NUM>. The flexible portion <NUM> is arranged on a distal section of the rear part <NUM> and axially biases the syringe <NUM> in the distal direction D.

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> are a schematic view of different embodiments of the flexible portion <NUM> of the syringe support <NUM>. The flexible portions <NUM> are biased axially in the distal direction D.

<FIG> shows a possible embodiment. The flexible portion <NUM> is designed as a bellow comprising two chambers <NUM> which are connected by two webs <NUM>.

The outer surfaces of the flexible portion <NUM>, namely the proximal surface attached to the projecting portion <NUM> and the distal surface of the free end, are flat.

Further at the distal flat end of the flexible portion <NUM> two ribs <NUM> are located which press against the syringe flange <NUM> in the assembled state to provide a secure axial support and positioning of the syringe <NUM> relative to the housing <NUM> in the distal direction D.

For assembling syringes <NUM> having variable lengths L within the same housing <NUM>, the flexible portion <NUM> is adapted to provide an axial force on the syringe flange <NUM> and to axially bias the syringe <NUM> in the distal direction D. At this, the flexible portion <NUM>, namely the bellow, is axially deflected and stressed so that the variable lengths L of the syringes <NUM> can be compensated and an axial movement of the syringe <NUM> is prevented during storage, transportation, drop and use.

<FIG> shows an alternative embodiment of the flexible portion <NUM> designed as a bellow with one chamber <NUM> and bent webs <NUM> coupling the chamber <NUM> and the projecting portion <NUM> and with supporting ribs <NUM> attached at the distal end.

<FIG> shows a further embodiment of the flexible portion <NUM> of a meander-shaped form with a bent flexural beam <NUM> running in a meander-shaped manner and with connecting webs <NUM> and supporting ribs <NUM>.

Furthermore, the flexible portions <NUM> may be designed in the form of a multiply folded or bent arc or half-arc or spring arm. Furthermore, the flexible portions <NUM> may be of an accordion-shaped, labyrinth-shaped, U-shaped, V-shaped, W-shaped or S-shaped design.

The flexible portion <NUM> of the syringe support <NUM> allows compensation of length tolerances of syringes <NUM> to be assembled as described above.

<FIG> is a schematic side view of the rear part <NUM> with the flexible portion <NUM> arranged on the distal end of the rear part <NUM>. The proximal end of the flexible portion <NUM> is attached to the projecting portion <NUM> and the distal end of the flexible portion <NUM> is formed as a free end axially biased.

<FIG> shows the front part <NUM> and the rear part <NUM> of the housing <NUM>. 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>.

<FIG> shows the syringe support <NUM> and the syringe <NUM> in an assembled state. The supporting ribs <NUM> attach the flange <NUM> of the syringe <NUM> when the syringe <NUM> is assembled into the syringe carrier <NUM> (the syringe carrier <NUM> is only illustrated in <FIG>).

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-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-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:
Autoinjector (<NUM>) comprising a housing (<NUM>), wherein the housing (<NUM>) comprises a syringe support (<NUM>, <NUM>') for supporting an axial position of a syringe (<NUM>) relative to the housing (<NUM>) of the autoinjector (<NUM>), wherein the syringe support (<NUM>, <NUM>') comprises:
- two projecting portions (<NUM>) which project from the syringe support (<NUM>, <NUM>') in a distal direction (D), characterized in that
each of the projecting portions (<NUM>) comprises a flexible portion (<NUM>) which axially adjoins the projecting portion (<NUM>) and axially extends from the projecting portion (<NUM>) in the distal direction (D), wherein the flexible portions are adapted to axially bias the syringe (<NUM>) in the distal direction (D) within the housing (<NUM>) when the syringe (<NUM>) is assembled, wherein the flexible portions (<NUM>) are adapted to accommodate to syringes (<NUM>) having variable lengths (L) within the housing (<NUM>) in the distal direction (D), wherein the flexible portions (<NUM>) are axially deflected and stressed so that the variable lengths (L) of the syringes (<NUM>) can be compensated and an axial movement of the syringe (<NUM>) relative to the housing is prevented during storage, transportation, drop and use, and wherein the flexible portions (<NUM>) are arranged opposed to each other.