Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3202—Devices for protection of the needle before use, e.g. caps
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
  • A61M5/321—Means for protection against accidental injuries by used needles
  • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
  • A61M5/3271—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
  • A61M5/321—Means for protection against accidental injuries by used needles
  • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
  • A61M5/3275—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel being connected to the needle hub or syringe by radially deflectable members, e.g. longitudinal slats, cords or bands
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
  • A61M2005/2006—Having specific accessories
  • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
  • A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
  • A61M5/321—Means for protection against accidental injuries by used needles
  • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
  • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
  • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
  • A61M5/321—Means for protection against accidental injuries by used needles
  • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
  • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
  • A61M2005/3261—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user triggered by radial deflection of the anchoring parts between sleeve and syringe barrel, e.g. spreading of sleeve retaining hooks having slanted surfaces by engagement with conically shaped collet of the piston rod during the last portion of the injection stroke of the plunger
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
  • A61M5/321—Means for protection against accidental injuries by used needles
  • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
  • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
  • A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body

Definitions

• Such an arrangement also leads to a reduction in the size of the device as the needle guard has several functions associated therewith thereby leading to a reduction of the number of parts needed and thus to a reduction of the volume of raw materials used.
• the needle guard may be configured to cooperate with a cap via one or more snap-fit connections, optionally with each snap fit connection comprising a protruding edge cooperating with a corresponding snap-fit area and wherein an inner surface of the housing comprises one or more grooves in which one or more of said protruding edges can axially move relative to the housing on an axial movement of the needle guard.
• a cap protects an accidental activation of the autoinjector in the storage state and also prevents an accidental contact of the user with a needle thereof.
• the one or more clip arms may each comprise a block at an end thereof, with the block being configured to engage a lock-out surface of the cut-out in the housing of the autoinjector in the lock-out state.
• a block respectively a projection protrusion or the like, enables the clip arm to engage a part of the housing to clip the needle guard, i.e. hook the needle guard into place after a medicament has been dispensed.
• the one or more clip arms may extend in a proximal direction from the needle guard. This aids in forming an as compact an autoinjector as possible.
• Fig. 7a to 7c part sectional views of the autoinjector, with a part of the housing removed, such that one can see components of a release mechanism of the autoinjector on activating the autoinjector;
• Fig. 10 a) a view of the position of a needle guard of the autoinjector relative to the housing in the storage state and b) a view of the position of the needle guard of the autoinjector relative to the housing in the lock-out state;
• FIG. 20a to j various views of the needle guard of Fig. 18;
• Fig. 21 an exploded view of components of further kind of autoinjector
• Fig. 22 a perspective view of a needle guard of the autoinjector of Fig. 21 ;
• Fig. 23 a perspective view of a drive chassis of the autoinjector of Fig. 21 ;
• Fig. 22 a perspective view of a needle guard of the autoinjector of Fig. 21 ;
• the plunger 26 may be a part separate from the dispensing limb 22 and may be pre-arranged within the pre-filled syringe and configured to be engaged by the dispensing limb 22.
• Fig. 3 shows the drive chassis 24.
• the drive chassis 34 comprises the dispensing limb 22 and a trigger limb 32.
• the trigger limb 32 and the dispensing limb 22 are arranged in parallel to one another.
• the drive chassis 24 is a component that is configured to move in a straight line within the housing in order to drive the medicament M out of the pre-filled syringe on activation of the autoinjector 10.
• the trigger limb 32 and the dispensing limb 22 are arranged in an at least generally U- shaped manner respectively in a U-shaped manner and are connected to one another at a distal end 38 of the drive chassis 24 via a web 42, i.e. axially offset from one another in the transverse direction T with a length of the trigger limb 32 being longer than a length of the dispensing limb 22.
• the stop feature 54 can be arranged at a height along the axial direction A of the housing 12 selected in the range of 30 to 70 % of the length of the housing 12 from the distal end 30 of the autoinjector 10.
• a cap 70 is installed at the proximal end 28 of the autoinjector 10. On removal of the cap 70, the needle guard 18 of the autoinjector 10 becomes accessible.
• the lock-out spring 76 is biased between the needle guard 18 and an inner body 80 of the housing 12.
• the drive spring 74 is arranged within the housing 12 of the autoinjector 10.
• the drive spring 74 is specifically arranged between a distal housing wall 84 and the drive chassis 24. More specifically the drive spring 74 is arranged between the distal housing wall 84 of the outer body 82 and within the trigger limb 32 of the drive chassis 24. In order to fix a position of the drive spring 74 this may be arranged at a projection 86 projecting proximally from the distal housing wall 84 of the outer body 82.
• the needle guard 18 comprises a projection 90 projecting distally from the proximal end 28.
• the lock-out spring 76 is arranged at the projection 90, in particular, the projection 90 projects into the lock-out spring 76.
• the needle guard 18 is configured to compress the lock-out spring 76 on moving between the storage state and the dispensing state. This is possible as the lock-out spring 76 abuts a proximal end 92 of the inner body 80 of the autoinjector 10 and the projection 90 is guided through an aperture 91 present in the inner body 80.
• the needle guard 18 is configured to be moved by a relaxation of the lock-out spring 76 between the dispensing state and the lock-out state in a proximal direction.
• the projection 90 could also be provided at the inner body 80 such that it projects towards the proximal end 28 of the needle guard 18. If this option is selected, then a length of the projection 90 has to be adapted such that the projection does not prevent a movement of the needle guard in the distal direction and/or such that it does not project beyond the needle guard 18 in the dispensing state so as to not come into contact with a patient’s skin, e.g. if it cooperates with an aperture (not shown) of the needle guard 18.
• the needle guard 18 In the storage state of the autoinjector 10, the needle guard 18 is arranged at a first axial position. In the dispensing state the needle guard 18 is arranged at a second axial position and in the lock-out state the needle guard 18 is arranged at a third axial position.
• the first, second and third axial positions respectively differ from one another, with the third axial position being more proximal than the first and second axial positions and the first axial position being more proximal than the second axial position with respect to the housing 12.
• the third axial position may be the same or very similar to the first axial position in other designs of the autoinjector 10.
• an outer length of the autoinjector 10 with the cap 70 removed is longest in the lock-out state, shortest in the dispensing state and of medium length in the storage state.
• Fig. 5a shows a perspective view of the removable cap 70.
• the cap 70 is of single piece design.
• the needle guard 18 is configured to cooperate with the cap 70 via one or more snap-fit connections 94, wherein each snap fit connection 94 comprises a protruding edge 96 (see e.g. Fig. 6) cooperating with a corresponding snap-fit area 98.
• each of the following components may be respectively integrally formed in one piece, preferably from one and the same material, e.g. in the same injection mold, namely the outer body 82, the inner body 80, the drive chassis 24, the needle guard 18, the cap 70, and/or the needle shield 78.
• the removable cap 70 has a base 100.
• the cap 70 tapers outwardly in the region of the base 100 such that the base 100 of the cap 70 has a larger outer diameter than the remaining cap 70. This is particularly beneficial as the base 100 can act as a stand for the autoinjector 10 in the storage state of the autoinjector 10.
• a needle guard facing end 102 of the cap 70 comprises a needle shield holder 104 at an end of the cap 70 disposed opposite to the base 100.
• the needle shield holder 104 is configured to hold the removable needle shield 78 covering the needle of the pre-filled syringe 16 in the storage state of the autoinjector 10.
• the inner wall 106 of the needle shield holder 104 further comprises two windows 112. A respective one of the inwardly facing projections 108 is arranged at each of the windows 112.
• the ribs 120 are configured to press radially inwardly, i.e. in the radial direction R, and transversely inwardly, i.e. in the transverse direction T, against the needle guard 18 in the storage state of the autoinjector 10.
• the snap-fit connection 94 holds the cap 70 in place in the storage state of the autoinjector.
• the cap 70 is removably connected to the needle guard 18 and, on removal of the cap 70, the needle shield 78 is also removed from the autoinjector 10, as the projections 108 of the cap press on the syringe facing surface 110 of the removable needle shield 78 to entrain the removable needle shield in the proximal direction on removal of the cap 70.
• an inner surface 128 of the outer body 82 comprises a groove 130 in which one of said protruding edges 96 can axially move relative to the outer body 82 on an axial movement of the needle guard 18.
• the snap-fit projection 96 thereby forms detent features on the needle guard 18 that engage with corresponding features on the cap in order to provide a tight axial fit between the components following assembly.
• a reverse arrangement of the detent features may also be possible, e.g. snap-fit areas may be present at the housing 12 and corresponding snap-fit projections could be present at the cap 70.
• the proximal side of these detent features (snap-fit projections 96) on the needle guard is relatively steep, i.e. the proximal side of the snap-fit projections 96 is steeper than the distal side of the snap-fit projections 96 in the axial direction, so that once the cap 70 is removed, if the user attempts to re-attach it, the force to re-engage the detent features is high enough to cause the needle guard 18 to be moved distally until the detent features are hidden within the housing 12.
• the distance by which the needle guard 18 is moved in order to hide the detent features is designed to be less than the distance required to trigger dispense, so that attempted reattachment of the cap 70 in this way does not trigger dispense.
• the cap 70 When the cap 70 is attached to the autoinjector 10, i.e. to the needle guard 18 via the snap-fit connection 94, the cap 70 prevents axial movement of the needle guard 18 when attached to the needle guard 18 in the storage state.
• the outer wall 116 of said cap 70 contacts an outer wall 136 of said housing 12 in the storage state of the autoinjector 10.
• the outer wall 116 of the cap 70 and the outer wall 136 of said housing 12 do not overlap in an axial direction A of the autoinjector 10.
• the outer wall 116 of the cap 70 and the outer wall 136 of the housing 12 radially overlap in the storage state of the autoinjector 10.
• outer wall 136 of the housing is the outer wall 136 of the outer body 82 forming a part of the two-part housing 12.
• Clip features in the form of the projections 108 on the cap 70 act on the distal surface of the rigid needle shield (RNS) 78 to grip onto it and remove it from the pre-filled syringe 16 when the cap 70 is pulled off by the user.
• RNS rigid needle shield
• a ‘three plate tool’ construction may be used to mould the cap 70, including the clip features (projections 108) in a single component in a common injection mold (not shown) where state of the art devices typically construct similar caps from two or more separate components.
• the projections 108 are supported by the needle guard 18 during removal of needle shield 78, helping to prevent them from splaying outwards and disengaging, as the needle shield holder 104 is biased radially inwardly by the needle guard 18.
• Fig. 7a to 7c show part sectional views of the autoinjector 10, with a part of the housing 12 removed, such that one can see components of the needle guard 18, the drive chassis 24, the pre-filled syringe 16 and the housing 12 on activating the autoinjector 10.
• Fig. 8a to 8c show detailed views of the different positions of the release mechanism 40 of the autoinjector 10 corresponding to the views shown in Figs. 7a to 7c.
• Fig. 8a shows an enlarged view of the components of the release mechanism 40 of the autoinjector 10 which comprises the trigger arm 36 of the drive chassis 24, and the stop feature 54 present in an opening 138 of the housing 12 with which the trigger arm 36 cooperates.
• the opening 138 of the housing 12 is indicated as a through-going opening, i.e. it is open both at an outer wall of the housing 12 as well as an inner wall of the housing 12. It should however be noted that it may also be formed as a recess in the inner wall of the housing 12 such that it does not go through the wall of the housing 12.
• the drive chassis 24 is mounted in said housing 12, the drive chassis 24 is biased with respect to said housing 12 via the drive spring 74.
• the drive chassis 24 is further fixed with respect to the housing 12 and a movement relative to the housing 12 in the storage state of the autoinjector 10 via the trigger arm 36 that is held at the opening 138.
• the drive spring 74 biases the trigger arm 36 in the axial direction A against the stop feature 54.
• the trigger arm 36 is present at the right hand side in the opening 138 (of the present Figure).
• the autoinjector 10 In order to activate the autoinjector 10 and to release the drive chassis 24 for its proximal movement, the autoinjector 10 comprises the release mechanism 40.
• the blocking rib 144 is also configured to block a radial movement of the trigger arm 36 during the storage state prior to the plunger arm 142 contacting the trigger arm 36 due to an axial movement of the needle guard 18.
• the trigger arm 36 When the engagement surface 146 contacts the web 148 respectively the deflection surface 150, the trigger arm 36 is configured to be moved, in particular disengaged, from said stop feature 54, through a deflection in the direction of the arrow B.
• the opening 138 at which the stop feature 54 is arranged comprises a surface 152 that has a convex shape.
• the trigger arm 36 is configured to cooperate with said convex surface 152 of said stop feature 54.
• the trigger arm 36 comprises a projection 154 engaging the stop feature 54.
• the projection 154 is configured to cooperate with said opening 138 by engaging into this and by resting on said surface 152 of the stop feature 54 at least in the storage state of the autoinjector 10.
• Fig. 8c shows the state in which the needle guard 18 has been moved distally with respect to the previous figures, i.e. the autoinjector 10 is illustrated in the dispensing state just before the drive spring 74 urges the drive chassis 24 proximally in the axial direction A, as the trigger arm 36 has been released from engagement with the stop feature 54.
• an angle of inclination between the first and second planar surfaces 156, 158 is selected in the range of 110 to 175°, preferably in the range of 120 to 170° and especially in the range of 130 to 165°.
• an angle between the first planar surface 156 and the axial direction A is selected in the range of 0 to 50°, especially in the range of 1 to 30° and most preferably in the range of 2 to 20°.
• an angle between the second planar surface 158 and the axial direction A is selected in the range of -20 to 20°, especially in the range of -10 to 10° and most preferably in the range of -5 to 5°.
• the apex 160 forms an overhauling angle the trigger arm 36 faces on activation of the autoinjector 10 in order to shift this from the storage state into the dispensing state.
• the drive spring 74 urges the drive chassis 24 in the axial direction A and the drive chassis 24 is axially held in position at the opening 138 via the protrusion 154 of the trigger arm 36.
• the protrusion 154 is so to say held in the acute space formed by the first planar surface 156 of the stop feature in the opening, as to move the trigger arm 36, this not only has to be moved in the transverse direction T but also distally in the axial direction A.
• the spring force of the drive spring 74 causes the drive spring 74 to relax and urge the drive chassis 24 proximally in the axial direction A and the trigger arm 36 out of engagement from the opening 138 as indicated e.g. in Fig. 8c or shown in Fig. 4c.
• the engagement surface 146 of the plunger arm has deflected the trigger arm 36 in the transverse direction T this can also be deflected radially inwardly in the radial direction R. As is shown in Fig.
• the trigger arm 36 of the drive chassis 24 Prior to dispense, the trigger arm 36 of the drive chassis 24 is biased into engagement with the axial stop feature 54 in the outer body 82 of the housing 12.
• the trigger arm 36 is discouraged from moving either transversely or radially inwards by: the negative inclined contact surface 156 of the outer body 82 of the housing 12, friction acting against them, the angle of the trigger arm 36, and the stiffness of the trigger arm 36.
• this geometry may require the drive chassis 24 to be slightly lifted and therefore the drive spring 74 to be slightly compressed in order to disengage the trigger arm 36.
• sufficient robustness i.e. protection against accidental triggering
• the blocking rib 144 on the needle guard 18 also prevent the trigger arm 36 from moving radially inwards. It would also be feasible to add further blocking rib features (not shown) to the needle guard to prevent transverse movement of the trigger arm 36. These transverse blocking rib features would be arranged such that, during the initial displacement of the needle guard 18 on actuation, they axially disengage from and release transverse movement of the trigger arm 36.
• the angled engagement surface 146 of the cam 162 of the needle guard 18 contacts the trigger arm 36 and translates its projection 154 transversely over the apex 160 of the stop feature 54 in the outer body 82 of the housing 12.
• Fig. 8b shows the release mechanism 40 at the point of triggering, in one optional embodiment, after a short transverse movement, the trigger arm 36 contacts the outer body 82 with a further angled face that forces it to move radially inwards until they disengage entirely from the stop feature 54.
• the inner body 80 further comprises a first cut-out 174.
• the first cut-out 174 being configured to cooperate with a clip arm 184 and a lock-out arm 186 of the needle guard 18.
• the trigger limb 32 further comprises at least a first part 56 of an audible end of dose feedback member 58 in the shape of a click arm 56.
• the first part 56 i.e. the click arm 56, is formed by a nose 60, optionally having a generally triangular outer shape, formed at an end of a tongue 62, projecting from the trigger limb 32.
• the tongue 62 projects from the trigger limb 32 in the region of a recess 64 formed in the outer surface 49 of the trigger limb 32.
• An opening 68 of the recess 64 faces in the radial direction R.
• Figs. 12a to 12f show various views of an example of the cap 70 of the autoinjector 10.
• the opening 124 of said cap 70 is formed between the outer wall 116 of said cap 70 and the needle shield holder 104.
• the dimensions of the opening are selected in dependence on the dimensions of the part of the needle guard that is to be inserted into the opening in the storage state to the autoinjector 10.
• the needle shield holder 104 projects distally from the base 100 of the cap 70 and is surrounded by the outer wall 116 of the cap 70.
• the inner surface 118 of the outer wall 116 of the cap 70 comprises several ribs 120. These ribs are configured to press against the front end 122 of the needle guard 18 when this is arranged within the opening 124.
• the cap 70 is of single piece design and an end face in a proximal surface of the cap 70 at the base 100 does not comprise a hole.
• Fig. 14a to 14j show various views of an example of the inner body 80 of the autoinjector 10.
• Figs. 14a and 14b show respective perspective views from two sides of the inner body 80.
• the distal housing end 204 having the recess formed thereat are shown at the top of Figs 14 and 14b.
• Figs. 14c to 14f show respective side views of the inner body 80
• Fig. 14g shows a section taken along the sectional line F:F of Fig.14e
• Fig. 14h shows a section taken along the sectional line E:E of Fig. 14f
• Fig. 14i shows a top view of the inner body 80
• Fig. 14j shows a section taken along the sectional line G:G of Fig. 14e.
• the needle guard 18 also comprises a single plunger arm 142 having two blocking ribs 144 and two cams shaped in the manner described in the foregoing.
• the blocking ribs 144 are configured to cooperate with the drive chassis 24 discussed in connection with Fig. 17 when inserted into the housing 12 comprising the outer body 82 discussed in connection with Fig. 13 and the inner body 80 discussed in connection with Fig. 14. It should also be noted that the blocking ribs 144 are arranged at opposite sides of the plunger arm 142.
• the section B:B of Fig. 16i indicates that the needle receptacle 212 is shaped complementary to the needle 34 of the pre-filled syringe 16.
• the function of the needle shield 78 is to protect the needle 34 from external influences.
• Fig. 17a to 17I show various views of an example of the drive chassis 24 of the autoinjector 10.
• the drive chassis 24 has two trigger arms 36 each with its respective components as discussed in the foregoing, a single audible feedback member 58 arranged at a side of the drive chassis 24.
• Fig. 17h shows a section taken along the sectional line F:F of Fig. 17e through the trigger limb 32 indicating the passage 140 formed therein.
• Fig. 17i shows a section taken along the sectional line G:G of Fig. 17f showing the parallel arrangement of the dispensing limb 22 and the trigger limb 32.
• Fig. 17k shows a section taken along the sectional line D:D of Fig. 17e and Fig. 171 shows a section taken along the sectional line C:C of Fig. 17e at a height of the drive chassis 24 where the two projections 154 are positioned relative to the trigger arms 36.
• the auto-injector device disclosed consists of an assembly surrounding a pre-filled syringe (PFS) 16 that contains medicament M.
• PFS pre-filled syringe
• Such devices are single-use and intended for administration by a patient (i.e. self-administration) or carer.
• the user removes the protective Cap 70 from the proximal end of the autoinjector 10, positions the autoinjector 10 at the injection site (typically the skin of the thigh or belly) and presses the autoinjector 10 axially in a proximal direction, to achieve needle insertion of the needle 34 into the skin and to initiate dispense.
• the injection site typically the skin of the thigh or belly
• the user is notified when the dose is complete by an audible click emitted from the autoinjector 10 and a change in the colour displayed within a unique ‘status indicator window’ 20.
• the autoinjector 10 can then be removed from the injection site, allowing the sprung needle guard 18 to extend to a locked position under the action of a separate helical compression spring 76 to cover the needle 34. In this locked position, the needle guard 18 covers the needle 34 and protects the patient or a further person from needle 34 stick injuries.
• Fig. 18a to 18e show various views of a further example of the needle guard 18 and the inner body 80 of the housing 12 in different states of use of a further type of autoinjector 10.
• the needle guard 18 is mounted axially moveable in the housing 12 for movement between a storage state, a dispensing state and a lock-out state in which states the needle guard 18 adopts different axial positions relative to the inner body 80 of the housing 12.
• Fig. 18a shows the needle guard 18 and inner body 80 of the autoinjector 10 prior to use.
• the one or more clip arms 184 of the needle guard 18 each comprise a block 184’ at an end thereof, with the block 184’ being configured to engage a lock-out surface 234 of the cut-out 174 in the housing 12 of the autoinjector 10 in the lock-out state.
• the block 184’ of the clip arm 184 may be positioned such that there is a transverse clearance to the corresponding inner body lock-out surface 234, thus ensuring the lockout surface 234 and the block 184’ cannot engage prior to triggering.
• the clip arm 184 of the needle guard 18 may be moulded to nominally position the block lower than the aperture 174’, so that some deformation of the compliant arm 184 is required to achieve this assembled state, and therefore a transverse biasing force exists which holds the block 184’ in the position shown.
• the block 184’ travels along the long limb 238 of the profiled aperture 174 until full travel of the needle guard 18 is reached, which may be limited by an abutment in another area of the mechanism.
• Fig. 18d shows the needle guard 18 and inner body 80 of the autoinjector 10 when the needle guard 18 is locked-out.
• the autoinjector 10 is removed from the user’s skin, and the lock out spring 76 of the needle guard 18 applies a force to extended the needle guard 18 in the proximal direction.
• the block 184’ travels proximally along the long limb 238 defined by the profiled aperture 174’ in the inner body 80. As the block 184’ travels along this path, further transverse deflection of the trigger arm 36 may occur, as the block 184’ slides along the surface of the trigger arm 36.
• the block 184’ is raised upwards within the profiled transverse movement due to the long limb 238 of the aperture 174’.
• the raised position of the block 184’ creates transverse overlap between a surface 240 of the block 184’ and the lock-out abutment surface 234.
• the needle guard 18 axial position is restricted to minimal movement between the surface 240 of the block 184’ and the lock-out abutment surface 234. If the needle guard 18 is biased distally towards the housing 12 of the autoinjector 10, the surface 240 contacts the lock-out abutment surface 234, preventing further distal movement of the needle guard 18.
• the surfaces 240, 234 are angled to encourage further engagement of these surfaces 240, 234, via further deflection of the compliant arm 184. In this state, the requirements of needle 34 protection can be met.
• the proximal end of the trigger arm 36 may raise to align transversely to the profiled aperture 174’ in the inner body 80. If this condition is reached, the end of the trigger arm 36 may move radially outwards, so that the trigger arm 36 becomes transversely restrained by the profiled aperture 174’. This state creates additional robustness, as the trigger arm 36 is locked in this raised state, creating maximum deflection in the complaint arm 184 in the needle guard 18 and maximising overlap between the surface 240 on the block 184’ and the lock-out abutment surface 234 on the inner body 80.
• Fig. 18f shows an area under a curve that represents energy absorbed (both areas and therefore energy absorptions are the same but the peak force is very different). Hence a higher peak force can be absorbed for shorter distances of travel.
• the inner body 80 has two profiled apertures 174’ as cut-outs 174 incorporated into respective sides of the inner body 80. There may be a single aperture 174’, but due to the general symmetry of the device, it may be beneficial to have a similar profiled aperture 174’ on both sides of the inner body 80.
• This further type of needle guard 18 and inner body 80 describe a mechanism to control the limits of travel of the needle guard 18 of the disposable autoinjector 10 used to dispense medicament from the pre-filled syringe 16.
• the mechanism disclosed permits full distal travel of the needle guard 18 to occur during initial use of the auto-injector, when a dispense event is initiated. After the dispense event has occurred and the autoinjector 10 has been removed from the injection site, the mechanism allows the needle guard 18 to travel to a final proximal position. Once in the final position, the needle guard 18 is locked out to prevent further distal travel. This lock is intended to withstand sufficient axial force to provide the required protection from the needle 34, even in the event of an impact resulting from dropping the autoinjector 10.
• the drive chassis 24 described in connection with the foregoing types of autoinjectors 10 can be used with the inner body 80 and the needle guard 18 and utilises the displacement of the Drive Chassis, which occurs during a dispense event, to provide the lock-out once the final position is reached.
• the forces required to axially displace the needle guard 18 into the final position are designed to be low, allowing the force output of the lock-out spring 76 to be minimised. This helps to achieve desirable low triggering forces, as the user must compress this spring 76 to operate the autoinjector 10.
• Fig. 23 shows a perspective view of the drive chassis 24 of the autoinjector of Fig. 21 .
• the principal difference is that an end of dose ramp 248 is provided at the trigger limb 32.
• the end of dose ramp 248 is configured to cooperate with an end of dose click arm 250 present on an inner surface of the inner body 80 as is visible in Fig. 24 b.
• the EoD click arm 250 passes through the proximal end of the drive chassis 24 and drops off the end of the EoD ramp 248, rapidly releasing its stored energy and creating an audible click.
• the EoD ramp 248 is arranged at the same or approximately the same axial position as a proximal end of the trigger arm 36 and of the first part outer surface 50 of the trigger limb 32.
• Fig. 28a to c show various views of the autoinjector 10 of Fig. 21 in a storage state in part schematic sectional views.
• Fig. 28a shows how the cap 70 is arranged at the proximal end 28 of the needle guard 18. This engagement is achieved via the snap fit connection 94 present between the snap fit area 98 of the cap and the snap fit projection 96 of the needle guard 18.
• the drive spring 74 is compressed and applies an axial load between the outer Body 82 and the drive chassis 24.
• Fig. 29a & b views of the autoinjector of Fig. 21 on triggering, i.e. activation, of the autoinjector 10.
• the user holds the outer body 82 and presses the needle guard 18 against the skin, so that the needle guard 18 is moved in the distal direction and inside the outer body 82, against the force of the lock-out spring 76 (which is compressed).
• the plunger arm 142 at the distal end of the needle guard 18 contacts the drive chassis 24 trigger arms 36 via the engagement surfaces 146 and pushes them transversely.
• the trigger arms 36 would require a low force to deform transversely i.e. be transversely flexible (to reduce the user force required to trigger the autoinjector 10) but be very stiff and strong axially (to avoid buckling under long term loads from the drive spring 74).
• the trigger arms 36 of the drive chassis may be formed thicker in the middle section (to increase buckling strength) and thinner at the root (to reduce transverse stiffness).
• an inner surface 128, 132 of the housing 12 comprises one or more grooves 130, 134 in which one or more of said snap-fit projections 96 can axially move relative to the housing 12 on a axial movement of the needle guard 18.
• the autoinjector 10 according to one of embodiments 1 to 40, further comprising a drive chassis 24 mounted in said housing 12, the drive chassis 24 being biased with respect to said housing 12, the drive chassis 24 further being fixed with respect to the housing 12 and for a movement relative to the housing 12 in a storage state of the autoinjector 10, the drive chassis 24 moving relative to the housing 12 on dispensing a material from the pre-filled syringe 16.
• the autoinjector 10 according to embodiment 41 , wherein the autoinjector 10 is configured to generate an audible end of dose feedback between the drive chassis 24 and the housing 12 once the material has been dispensed from the autoinjector 10.
• the autoinjector 10 according to one of embodiments 1 to 42, further comprising a drive chassis 24 mounted in said housing 12, the drive chassis 24 being biased with respect to said housing 12 by a drive spring 74, the drive chassis 24 further being fixed with respect to the housing 12 and a movement relative to the housing 12 in a storage state of the autoinjector 10.
• the autoinjector 10 according to one of embodiments 1 to 45, further comprising a needle shield 78 covering a needle 34 of the pre-filled syringe 16 in a storage state of the autoinjector 10, the axially moveable needle guard 18 arranged to cover the needle 34 of the pre-filled syringe 16 at least after use of the autoinjector 10 and to move relative to the pre-filled syringe 16 during use of the autoinjector 10, as well as a removable cap 70 in which the needle guard 18 is stored in the storage state of the autoinjector 10.
• the autoinjector 10 according to one of embodiments 1 to 47, further comprising a drive chassis 24 mounted in said housing 12, the drive chassis 24 being biased with respect to said housing 12 and being fixed with respect to the housing 12 in a storage state of the autoinjector 10.
• the autoinjector 10 according to one of embodiments 1 to 49, further comprising a drive chassis 24, the drive chassis 24 comprising a dispensing limb 22 and a trigger limb 32, wherein a plunger 26 is arrangable at a proximal end of said dispensing limb 22 and a trigger arm 36 is arranged extending proximally from said trigger limb 32.
• the autoinjector 10 according to one or more of the preceding embodiments, wherein the housing 12 comprises a recess 208 and the drive chassis 24 engages the recess 208 to generate the audible end of dose feedback.
• the housing 12 comprises a chamfered distal inner housing end 204 on an inner surface 132 thereof.
• the chamfered distal inner housing end 204 deflects a part of the drive chassis 24 radially inwardly as this moves from the storage state to an end of dose state.
• the autoinjector 10 according to one or more of the preceding embodiments further comprising a drive spring 74 mounted between the drive chassis 24 and the housing 12.
• connection 72 is formed by a nose 188 engaging a window 190.
• the inner body 80 comprises one or more cut-outs 174, 176 and/or holes 168 that are configured to cooperate with one or more corresponding parts 184, 186, 166 of the needle guard 18.
• the autoinjector 10 according to one or more of the embodiments 68 to 74 and one or more of the embodiments 54 to 66, wherein the drive spring 74 is arranged between the outer body 82 and the drive chassis 24.
• the drive chassis 24 is of generally U-shaped design and comprises a dispensing limb 22 as well as a trigger limb 32.
• An autoinjector 10 optionally in accordance with one or more of the preceding embodiments, the autoinjector 10 comprising: a housing 12 in which a pre-filled syringe 16 is arranged, a drive chassis 24 mounted in said housing 12, the drive chassis 24 being biased with respect to said housing 12 by a drive spring 74, the drive chassis 24 further being fixed with respect to the housing 12 and a movement relative to the housing 12 in a storage state of the autoinjector, the drive chassis 24 comprising a trigger arm 36 engaging a stop feature 54 present in the housing 12 in the storage state of the autoinjector 10 for fixing the drive chassis 24 with respect to the housing 12, and wherein the trigger arm 36 is configured to be disengaged from said stop feature 54 on activation of the autoinjector 10.
• an autoinjector 10 optionally in accordance with one or more of the preceding embodiments, the autoinjector 10 comprising a pre-filled syringe 16 arranged within a housing 12 of the autoinjector 10, a needle shield 78 covering a needle 34 of the pre-filled syringe 16 in a storage state of the autoinjector 10, an axially moveable needle guard 18 arranged to cover the needle 34 of the pre-filled syringe 16 at least after use of the autoinjector 10 and to move relative to the pre-filled syringe 16 during use of the autoinjector 10, as well as a removable cap 70 in which the needle guard 18 is stored in the storage state of the autoinjector 10, wherein the cap 70 is removably connected to the needle guard 18 in the storage state of the autoinjector 10, and wherein, on removal of the cap 70, the needle shield 78 is also removed from the autoinjector 10. 101.
• the autoinjector according to one or more of the preceding embodiments, wherein
• each snap fit connection 94 comprises a snap-fit projection 96 cooperating with a corresponding snap-fit area 98.
• the autoinjector 10 according to according to one or more of the preceding embodiments, further comprising a syringe window 14 via which the pre-filled syringe 16 is visible from the outside.
• the autoinjector 10 according to one or more of the preceding embodiments, further comprising a drive spring 74 mounted between an end of the housing 12 and the drive chassis 24.
• An autoinjector 10 optionally according to one or more of the preceding embodiments, comprising a drive chassis 24, the drive chassis 24 comprising a dispensing limb 22 and a trigger limb 32, wherein a plunger 26 is arranged at a proximal end of said dispensing limb 22 and a trigger arm 36 is arranged extending proximally from said trigger limb 32, wherein the trigger limb 32 and the dispensing limb 22 are arranged in parallel to one another respectively at least essentially in parallel to one another and are connected to one another at a respective distal side of the dispensing limb 22 and the trigger limb 32.
• An autoinjector 10 according to embodiment 145 or embodiment 146, wherein the trigger arm 36 is biased with respect to a housing 12 of the autoinjector 10 in a storage state of the autoinjector 10.
• the autoinjector 10 according to one or more of the preceding embodiments, further comprising a drive spring 74.
• the autoinjector 10 according to one of embodiments 151 to 153, wherein the drive spring 74 is configured to drive the plunger 26 of the autoinjector 10 in a pre-filled syringe 16 of the autoinjector 10.
• the trigger limb 32 further comprises at least a first part 56 of an audible end of dose feedback member 58.
• the autoinjector 10 according to embodiment 159, further comprising a housing 12, wherein the housing 12 further comprises at least one second part 66 of the audible end of dose feedback member 58, optionally wherein the housing 12 is formed by an outer body 82 and an inner body 80 and one of the inner body 80 and the outer body 82 comprises said at least one second part 66 of the audible end of dose feedback member 58.
• the autoinjector 10 according to embodiment 159 or embodiment 160, wherein the first and second parts 56, 66 of the audible end of dose feedback members 58 are formed by a recess 208 and a latching tongue 62 configured to cooperate with the recess 208.
• the autoinjector 10 according to one of embodiments 159 to 161 , wherein the audible end of dose feedback member 58 is configured to emit a sound once the material has been dispensed from the autoinjector 10.
• the autoinjector 10 according to one of embodiments 159 to 162, wherein the audible end of dose feedback member 58 is configured to emit a sound between the drive chassis 24 and the housing 12 once the material has been dispensed from the autoinjector 10.
• the inner body 80 further comprises a first cut-out 174, with the first cut-out 74 being configured to cooperate with a clip arm 184 and a lock-out arm 186 of the needle guard 18.
• the drive chassis 24 further comprises a second trigger arm 36.
• the second trigger arm 36 is arranged at a side of the drive chassis 24 disposed opposite to the first trigger arm 36.
• the autoinjector 10 according to one or more of the preceding embodiments, wherein the trigger limb 32 comprises a lip 216 at an end disposed opposite to the web 42.
• the needle shield 78 comprises a needle receptacle 212 configured to receive the needle 34 of the pre-filled syringe 16.
• the cap 70 comprises a needle shield holder 104 that is configured to receive the needle shield 78.
• the autoinjector 10 according to one of embodiments 180 to 182, wherein the one or more clip arms 184 are configured to be deflected inwardly by the drive chassis 24 on a proximal movement of the drive chassis 24.
• the needle guard 18 comprises one or more protrusions 166 cooperating with a respective one of one or more elongate holes 168 present in the inner body 80.
• the one or more protrusions 166 are provided to ensure a linear guidance of the needle guard 18 relative to the inner body 80.
• the inner body 80 comprises one or more elongate holes 168 each having a proximal stop 172, wherein the proximal stop 172 prevents a respective one of the protrusions 166 from being moved proximally beyond the stop 172.
• the autoinjector 10 according to one or more of the preceding embodiments, wherein the inner body 80 of the housing 12 further comprises at least a part 66 of an audible end of dose feedback member 58.
• the autoinjector 10 according to embodiment 196, wherein the part 66 of the audible end of dose feedback member 58 comprises an inner body recess 206 having a distal surface 196 and a proximal surface 198 surrounding the inner body recess 206.
• each stop feature 54 is provided at a respective opening 138.
• an outer surface 49 of the trigger limb 32 comprises a first and a second part outer surface 50, 52 whose appearance differ from one another.
• a block 184’ of the clip arm 184 is arranged between a lock-out surface 234 and an extended abutment surface in the lock-out state of the autoinjector 10.
• a respective trigger arm 36 is configured to engage a respective one of the clip arms 184 for locking the needle guard in the lock-out state.

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• 2022
  • 2022-10-26 EP EP22813113.2A patent/EP4392097A1/de active Pending
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