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.

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 needle sheath, insertion of the needle, providing the force for administering the injection and possibly removal and shielding of the used needle.

To protect the needle of the device from damage or to protect people from needle-prick injuries before using of the device, the needle is covered by a protective needle cap or the so-called protective or rigid needle sheath (shortly named RNS).

In order to prepare the autoinjector device for delivering a dose, the protective needle sheath has to be removed from the needle. This may be done by gripping or grasping the protective needle sheath and pulling it away from the needle.

<CIT> discloses a remover for a protective needle shield for protecting a hollow injection needle of a syringe, the syringe arrangeable in an elongate housing of an injection arrangement having an orifice at a proximal end intended to be applied against an injection site, wherein the remover comprises a cap attachable to the proximal end of the housing, wherein a resilient clip is attached to the cap for joint axial movement and independent rotation, the resilient clip arranged to extend through the orifice into the housing when the cap is attached to the housing, wherein the resilient clip comprises at least two barbs arranged for snapping into a circumferential notch or behind a shoulder of the protective needle shield attached to the hollow needle.

There remains a need for an improved grasper for the protective needle sheath and a cap with such an improved grasper and an autoinjector comprising such a cap with an improved grasper so that the protective needle sheath can be securely removed from the autoinjector.

An object of the present disclosure is to provide an improved grasper for the protective needle sheath and a cap with such an improved grasper and an autoinjector comprising such a cap with an improved grasper so that the protective needle sheath can be securely removed from the autoinjector.

The object is achieved by a grasper according to claim <NUM>, by a cap according to claim <NUM>, by an autoinjector according to claim <NUM> and by a method of producing a grasper according to claim <NUM>.

Exemplary embodiments are provided in the dependent claims.

According to the present disclosure, a grasper for a needle sheath removably arranged over a needle is provided, wherein the grasper comprises a grasping carrier which is formed of a sheet and which is multiply bent along a plurality of longitudinal fold edges to form a plurality of carrier portions, wherein more than one of the plurality of carrier portions comprises a respective barb projecting from the surface of the carrier portion.

According to an alternative present disclosure, a grasper for a needle sheath removably arranged over a needle is provided, wherein the grasper is formed as an injection moulding part comprising a grasping carrier with a plurality of angled carrier portions, wherein more than one of the plurality of carrier portions comprises a respective barb projecting from the surface of the carrier portion.

The barb, being bent from a single piece of sheet, is simple to manufacture, leading to high manufacturing yields and low part cost. Furthermore, the grasper is easy to assemble into an autoinjector cap or a needle sheath remover. The barbs allow automatic gripping and removal of the protective needle sheath when an autoinjector cap is removed.

According to an exemplary embodiment, the grasping carrier is a single piece of sheet metal. In particular, the grasping carrier is formed from a sheet of steel or aluminium. Alternatively, the grasping carrier may be formed as rigid plastic or an injection moulding part. A single piece of sheet metal allows a variety of shapes and thin thickness. A single piece of rigid plastic or injection moulding parts are manufactured easier and more cost-efficiently.

Moreover, in an initial state the grasping carrier is flat. In a bent state, the grasping carrier has a pipe-form or cylinder-form with a polygonal cross section, e.g. a multi-facetted form. This concept increases the strength and stiffness of the grasping carrier and reduces stamping operation to manufacture. The shape of the grasping carrier may be varied and such that the grasper encircles the needle sheath to such an extent that a mechanical attachment, e.g. a locking connection between the grasper and the needle sheath is created.

In an exemplary embodiment, the grasping carrier is bent in such a manner that the outer carrier portions are partly overlapped. Hence, in the final bent state, the grasping carrier has a nearly circular cross section. During manufacture, nesting is prevented and bulk packaging is allowed. Furthermore, the overlapped carrier portions in the final bent state allow compensating manufacturing tolerances of graspers.

In a further exemplary embodiment, at least two of the plurality of carrier portions comprise a cut-out from which the barbs are bent in the same direction. In particular, the barbs are bent inwards to engage and grip the protective needle sheath.

In a possible embodiment, the barbs have a hook-form or prong-form. In particular, the barbs formed as hooks dig into the outer surface of the protective needle sheath and form a positive and/or non-positive connection during removing of the protective needle sheath.

In a further embodiment, the grasping carrier comprises one or more retaining slots or retaining lugs. Due to the low wall thickness of the grasping carrier, the grasping carrier can be assembled to an autoinjector cap of the autoinjector and both can be arranged to the protective needle sheath encasing the needle. The retaining slots or retaining lugs allow fixing of the grasping carrier and thus of the grasper in the autoinjector cap so that, in use, if the autoinjector cap is moved away from the autoinjector, it takes the grasper and with the grasper the protective needle sheath with it and removes them from the autoinjector and thus from the needle.

In a possible embodiment, the retaining lugs and the barbs are radially bent in opposite directions from the grasping carrier. In particular, the retaining lugs are bent outwards to grip, e.g. dig, into an inner cap surface of the autoinjector cap and the barbs are bent inwards to grip, e.g. dig, into the outer surface of the protective needle sheath. Furthermore, the retaining lugs and the barbs are bent in radial direction in different directions, namely outwards and inwards, and in axial direction in different directions, namely rearwards and forwards.

According to another aspect of the present disclosure, a cap for an autoinjector is provided wherein the cap comprises a grasper as described above. The cap is adapted to form a needle sheath remover and serves for a safe and easy assembling to the autoinjector wherein only axial force appears on the needle sheath during assembling so that needle damages are prevented and thus the needle will not be contaminated during assembly.

In an exemplary embodiment, a mounting support is arranged on an inner cap surface and adapted to retain the grasper in the cap. For example, the mounting support comprises holding lugs or holding slots corresponding to the retaining slots or retaining lugs of the grasper.

According to another aspect of the present disclosure, an autoinjector is provided wherein the autoinjector comprises a grasper as described above and a cap as described above, wherein the grasper is fixed in the cap and wherein the cap is removably arranged on the autoinjector.

In an exemplary embodiment, the cap and the grasper are connected in such a manner that removal of the cap together with the grasper from the autoinjector removes the needle sheath from the needle.

In a further exemplary embodiment, the barbs are adapted to deflect and grip the needle sheath during assembly of the needle sheath into the autoinjector and adapted to further grip the needle sheath when the cap is being removed from the autoinjector.

The barbs are bent radially inwards. The grasper is assembled into the cap in such a manner that the free ends of the angled barbs extend into the distal direction.

According to another aspect of the present disclosure, a method for producing a grasper is provided wherein the method comprises the steps:.

Alternatively, the grasper as a single injection moulding part may be manufactured using injection moulding.

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 spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.

The present disclosure will become more fully understood from the detailed description given below and the accompanying drawings, which are given by way of illustration only, and do not limit the present disclosure, 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 <NUM> therein by a syringe support <NUM>.

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 (shortly named RNS) which is composed of rubber or 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 <NUM> 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>.

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.

Due to manufacturing tolerance, syringes <NUM> may have variable lengths. 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> extend radially inwards or longitudinally to accommodate the variable length 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 of the syringe <NUM> in the distal direction D.

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 outer 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 grasper <NUM> arranged to engage and grip the protective needle sheath <NUM>. The grasper <NUM> forms an inner grip element and is fixed to the cap <NUM>.

The cap <NUM> is adapted to form a needle sheath remover. For this purpose, the cap <NUM> and the grasper <NUM> are connected in such a manner that removal of the cap <NUM> together with the fixed grasper <NUM> from the autoinjector <NUM> removes the protective needle sheath <NUM> from the needle <NUM>.

In other words: The grasper <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>.

Furthermore, 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..

<FIG> and <FIG> show an exemplary embodiment of a grasper <NUM> formed of single piece. <FIG> shows an exemplary embodiment of a cross section of the grasper <NUM>.

The grasper <NUM> comprises at least a grasping carrier <NUM>. The grasping carrier <NUM> is multiply bent along a plurality of longitudinal fold edges <NUM> to form a plurality of carrier portions <NUM>. Furthermore, the grasping carrier <NUM> is bent or angled in such a manner that the outer carrier portions <NUM> are partly overlapped in an overlapping area <NUM>. Hence, in the bent state the grasping carrier <NUM> has a pipe-form with a polygonal cross section. The partly overlapped area <NUM> in the bent state of the grasping carrier <NUM> allows compensation of manufacturing tolerances of the grasper <NUM>.

To grip the protective needle sheath <NUM>, more than one of the plurality of carrier portions <NUM> comprises a cut-out <NUM> from which a respective barb <NUM> is bent and projected inwards from the inner surface of the grasping carrier <NUM> and thus of the carrier portions <NUM>. In the assembled state, the inwardly angled barbs <NUM> extend in the distal direction D of the autoinjector <NUM>.

The barbs <NUM> are adapted to deflect and grip the protective needle sheath <NUM> during assembly of the needle sheath <NUM> into the autoinjector <NUM> and adapted to further grip the needle sheath <NUM> when the cap <NUM> is being removed from the autoinjector <NUM>.

The barbs <NUM> are designed as hooks or have a prong-form. In particular, the barbs <NUM> are inwardly projected from the inner surface of the carrier portions <NUM> and comprise on its free end prongs <NUM>. The prongs <NUM> are adapted to press onto or dig into the outer surface of the protective needle sheath <NUM> and to form an interference fit during assembling or a positive and/or non-positive connection at least during removing of the protective needle sheath <NUM>. According to another aspect, the prongs <NUM> may be adapted to already dig into the outer surface of the protective needle sheath <NUM> when the grasper <NUM> is being assembled to the protective needle sheath <NUM> as described above.

According to the present embodiment, the prongs <NUM> are configured as double spikes respectively arranged on each barb <NUM>. This configuration is realized by a concave shape respectively between two prongs <NUM> per barb <NUM>. Due to the concave shape and thus controlling the distance between the prongs <NUM>, a penetration depth into the surface of the protective needle sheath <NUM> may be limited. This is particularly important, when the protect needle sheath <NUM> is a rubber needle sheath where penetration could impact sterility by accessing the needle <NUM>.

Furthermore, for correct orientation of the grasper <NUM> during assembling within the cap <NUM>, the grasper <NUM> comprises an orientation element <NUM> indicating an assembling orientation. The orientation element <NUM> is designed as a tactile indicator or visual indicator or a combination of them. In particular, one of the front surfaces of the grasping carrier <NUM> is profiled, e.g. waved or pronged, and the other opposite front surface is even and flat.

<FIG> shows an exemplary embodiment of a single piece of a sheet <NUM> forming the grasper carrier <NUM>.

According to an aspect of the present disclosure, the grasper <NUM> is produced by the following steps:.

The sheet <NUM> may be a single piece of sheet metal which is cut to form the cut-outs <NUM> and barbs <NUM> in the cut-outs <NUM>.

Instead of the single-piece metal sheet, the grasper <NUM> may be formed as a single-piece plastic sheet or single-piece plastic part produced by injection moulding and bending or only by injection moulding. The alternative grasper <NUM> is formed as a single injection moulding part.

According to this alternative design of the grasper <NUM>, the grasper <NUM> is manufactured by using injection moulding to form the grasping carrier <NUM> with angled carrier portions <NUM>, wherein more than one of the plurality of carrier portions <NUM> comprises the respective inwardly angled barb <NUM> projecting from the surface of the carrier portion <NUM>.

Regardless of the manufacturing method, the form and design of the grasper <NUM> made from a bent sheet or produced by injection moulding is the same. Hence, the described disclosure of the design and form of the grasper <NUM> applies to both embodiments.

To retain the grasper <NUM> within the cap <NUM>, the sheet <NUM> comprises at least one retaining slot <NUM> formed by cutting into the grasping carrier <NUM>. In the present embodiment, for example two retaining slots <NUM> are provided. The retaining slots <NUM> serve for retaining the grasper <NUM> within the cap <NUM> e.g. by holding lugs <NUM> of the cap <NUM> shown in <FIG>.

In an alternative embodiment, for retaining the grasper <NUM> within the cap <NUM>, the grasping carrier <NUM> may comprise retaining lugs <NUM> (dotted line) and the cap <NUM> may comprise holding slots (not shown). In this case, the optional retaining lugs <NUM> and the barbs <NUM> of the grasper <NUM> are radially bent in opposite directions from the grasping carrier <NUM>.

In particular, the grasping carrier <NUM> is formed as an anchoring part comprising the plurality of barbs <NUM> or claws inwardly directed away from the grasping carrier <NUM> and at an angle in the direction to a longitudinal axis A of the grasper <NUM> and bearing against the outer surface of the needle sheath <NUM> to grip the needle sheath <NUM> wherein the retaining lugs <NUM> are outwardly bent and oriented at an angle away from the axis A and bearing against the inner cap surface of the cap <NUM> to grip the cap <NUM>.

<FIG> is a cut-away view of an exemplary embodiment of a cap <NUM> with an assembled grasper <NUM> which is retained in the cap <NUM> by the holding lugs <NUM>, engaging the retaining slots <NUM>. The grasper <NUM> is fixed in the cap <NUM>. The cap <NUM> comprises the outer grip feature <NUM> which may be gripped by a user to remove the cap <NUM> from the autoinjector <NUM> wherein the cap <NUM> takes the grasper <NUM> and with the grasper <NUM> the protective needle sheath <NUM> with it and removes them together from the autoinjector <NUM> and thus from the needle <NUM>.

The barbs <NUM> are inwardly bent or angled and extend in the distal direction D to grasp the needle sheath <NUM> in the assembled state or at the latest during removing of the protective needle sheath <NUM> by removal of the cap <NUM>.

<FIG> is a cut-away view of an exemplary embodiment of a cap <NUM> with an assembled grasper <NUM> and a protective needle sheath <NUM> assembled in the grasper <NUM> by an interference fit of the barbs <NUM> and the needle sheath <NUM>. The part of the needle sheath <NUM> which is retained in the grasper <NUM> is shown in a transparent manner to show the interference fit of the barbs <NUM> and the needle sheath <NUM>.

Alternative to the interference fit of the barbs <NUM> and the needle sheath <NUM>, the barbs <NUM> may be dug into the outer surface of the needle sheath <NUM> to form a mechanical locking connection, e.g. a force-locking connection, form-fitting connection and/or friction-locking connection by interlocking structures, hooks and eyes or protrusions and undercuts, profiled surfaces etc. at least during removing of the protective needle sheath <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-(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:
Grasper (<NUM>) for gripping a needle sheath (<NUM>) removably arranged over a needle (<NUM>) of an autoinjector, wherein
the grasper (<NUM>) is characterised by
- a grasping carrier (<NUM>) formed of a sheet (<NUM>) and multiply bent along a plurality of longitudinal fold edges (<NUM>) to form a plurality of carrier portions (<NUM>), wherein more than one of the plurality of carrier portions (<NUM>) comprises a respective barb (<NUM>) projecting from the surface of the carrier portion (<NUM>) for gripping the needle sheath (<NUM>).