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
  • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
  • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
• • 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
• • 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
  • A61M5/20—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
  • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
  • A61M2005/2086—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically having piston damping means, e.g. axially or rotationally acting retarders
• • 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
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
  • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking

Definitions

• Automatic liquid product injection device comprising an injection spring
• the present invention relates to the field of automatic liquid product injection devices, in particular pharmaceutical.
• An automatic injection device is generally a medical device for the automatic administration of a liquid drug requiring injection. These devices allow in particular that people, for example with rheumatoid arthritis, multiple sclerosis, diabetes or undergoing anaphylactic shock in case of allergy, themselves inject their drug dose autonomously.
• an automatic injection device comprises an injection syringe which contains the liquid product to be injected and which is provided with a needle and a syringe holder. It is usually sufficient for a short pressure exerted by pressing on the skin of the patient to trigger a penetration of the needle into the skin, followed by an injection of the liquid product, then the retraction of the needle inside the patient. device to avoid hurting a person with the needle.
• the automatic injection device comprises two springs in compression.
• a first spring is housed at the proximal end of the device and has a power, capable of automatically moving elements, including the injection needle, to penetrate the injection needle into the patient's body and trigger the injection. injecting the liquid product to be injected.
• the second spring has the function of retracting the injection needle inside the device at the end of the injection.
• US 6 203 530 discloses an automatic injection device comprising retractable stops but not comprising locking members of these stops.
• the present invention aims to provide an automatic injection device whose reliability is improved.
• an automatic liquid product injection device having a distal end and an opposite proximal end, comprising:
• an injection spring deformable between a compressed state before use of the automatic injection device and a relaxed state after injection
• a piston control member configured to apply a force to a piston under the action of the injection spring to allow displacement of the piston in the distal direction of the automatic injection device, the piston control member carrying a retractable abutment between an active configuration for retaining the injection spring in the compressed state and a retracted configuration for releasing the injection spring,
• a locking member for the retractable abutment in its active configuration this locking member being able to assume a locking position, in which it exerts pressure on the retractable stop to prevent it from taking its retracted configuration, and an unlocking position; wherein the retractable stop is free to take its retracted configuration.
• the locking member it becomes impossible for the retractable stopper to accidentally pass into a retracted configuration and thereby release the injection spring.
• This locking is particularly useful during transportation or storage of the automatic injection device prior to use.
• the locking is also very advantageous in case of accidental fall of the automatic injection device, especially just before use.
• this locking member is particularly relevant when using a relatively powerful injection spring, because it is then more difficult to maintain the retractable stop in active configuration due to the strength of the spring. It thus becomes possible to use particularly rigid springs, and thus to inject a product having a higher viscosity than before.
• an injection spring having a force in the compressed position of 20 Newton or even 50 Newton or 80 Newton or more.
• the injection axis corresponds to the axis of the automatic injection device, corresponding to the axis of the injection needle.
• the injection axis will be called X.
• the distal direction designates the direction farthest from the fingers of a user, i.e. the closest to the skin of a patient at the time of an injection
• the proximal direction refers to the opposite direction.
• the distal direction is the one that goes to the "front” of the automatic injection device.
• the distal end of a patch corresponds to the end on the side of the injection needle, and the proximal end is the opposite end.
• the automatic injection device may further include one or more of the following claims, taken alone or in combination.
• the locking member comprises a central locking pin provided in the proximal end of an outer casing of the automatic injection device. It is thus a particularly simple and economical form to implement.
• the proximal end of the outer housing comprises a radial surface, recessed in the vicinity of the unlocking pin so as to be traversed by an elastic lug carrying the retractable stop at least when the locking member is in the locking position.
• the locking pin comprises two axially distributed sections of different diameters, namely a locking section and an unlocking section, the locking section having a radial dimension which is greater than a radial dimension of the unlocking section if one considers an axial section passing through the retractable stop, so that the locking section exerts a radial pressure on the retractable stop when the locking member is in the locking position, and the unlocking section creates a clearance space of the retractable stop when the locking member is in the unlocking position.
• the locking member carries a ramp designed to cooperate by ramp effect with an elastic tab bearing the retractable stop to move it from the active configuration to the retracted configuration.
• the transition from the locking position to the unlocking position of the locking member is triggered by a support of the distal end of the automatic injection device on the skin of a patient.
• the unlocking is activated, without the user being aware of it. This is particularly advantageous for cases where the user would drop the automatic injection device just before injecting.
• the retractable stop is radially spaced when it is in its active configuration, in particular to take a radially projecting position, and the retractable stop is radially retracted when it is in its retracted configuration, in particular to take a position radially retracted.
• the retractable abutment is carried by an elastic tab extending axially toward the proximal end of the automatic injection device, the elastic tab being deformable between a radially spaced rest configuration giving the retractable abutment its active configuration and a radially retracted configuration. giving the retractable stopper its retracted configuration.
• the retractable abutment in active configuration abuts against a complementary surface carried by a spring retaining ring, this retaining ring being attached to a positioning control member comprising a cam path to regulate the movement of elements of the device. automatic injection under the effect of the injection spring.
• the piston control member comprises two diametrically opposed semi-annular elastic tabs, each bearing a retractable abutment, each semi-annular elastic tab having a longitudinal window allowing deformation to facilitate the assembly of the injection spring and a retaining ring of the spring around the two semi-annular elastic tabs.
• FIG. 1 is a perspective view of an automatic injection device according to an embodiment
• FIG. 2 is an exploded perspective view of the automatic injection device of FIG. 1,
• FIGS. 3 and 4 are perspective views respectively from the proximal end and from the side of a removal member of the protective cap of the automatic injection device of FIG. 1,
• FIGS. 5 and 6 are perspective views respectively from the proximal end and from the distal end of an end sleeve of the automatic injection device of FIG. 1
• FIG. 7 is an exploded perspective view of the removal member of the protective cap and the end sleeve of the automatic injection device of FIG. 1;
• FIGS. 8 and 9 are perspective views respectively complete and in axial section of a syringe holder of the automatic injection device of FIG. 1,
• FIG. 10 is an axial axial sectional view of the end sleeve, the syringe holder and the protective springs of the automatic injection device of FIG. 1,
• FIGS. 11, 12 and 15 are side perspective views respectively of a positioning ring, a piston rod and a needle control member of the automatic injection device of FIG. 1,
• Figures 13 and 14 are respectively a cross-sectional and axial sectional view of the syringe holder in which are assembled the injection syringe, the positioning ring and the piston rod of the automatic injection device of Figure 1,
• the figures 16 to 18 and 20 are perspective side views respectively of a piston control member, a retaining ring, a positioning control member and an outer casing of the automatic injection device.
• FIG. 1
• FIG. 19 being a perspective sectional view from the distal end of the outer casing of FIG. 20,
• FIG. 21 is a partial perspective view from the proximal end of the piston control member, the piston rod and the retaining ring during liquid product injection of the automatic injection device of FIGS. FIG. 1;
• FIGS. 22 and 23 are partial axial sectional views of the automatic injection device of FIG. 1, showing a locking member respectively in the locked and unlocked position,
• FIGS. 24, 25, 27 and 28 are views in axial section of the withdrawal member, the end sleeve, the syringe holder and the injection syringe of the automatic injection device of FIG. 1, respectively at the time of insertion of the injection syringe into the syringe holder; once the injection syringe is inserted, in storage configuration; once the protective cap is removed and before insertion of the injection needle into the skin of a patient; and once the injection needle is inserted into the skin of a patient,
• FIG. 26 is an axial perspective sectional view of the end sleeve, the syringe holder and the injection syringe of the automatic injection device of FIG. 1, illustrating the removal of the protective cap
• Figures 29, 31 to 34 are perspective views, and in partial axial section, of several assembled elements of the automatic injection device of Figure 1, respectively in the storage position before removal of the protective cap; during the insertion of the injection needle into the skin of a patient; during the injection, the piston control member being entirely in FIG. 32 and in axial section in FIG. 33, and in the protective position, and
• Figure 30 is an axial perspective sectional view of the automatic injection device of Figure 1, shortly after a support of the distal end of the automatic injection device on the skin of a patient.
• An automatic liquid product injection device 10 allows the automatic administration of a liquid product requiring an injection, namely a drug. It is intended to receive an injection syringe 12 (visible in particular in Figure 26) containing the liquid product.
• the automatic injection device 10 comprises a number of parts, more specifically in this example a syringe holder 14, two springs 15a, 15b, an end sleeve 16, a a protective cap removal member 42, a piston rod 19, a positioning ring 50, a positioning control member 20, a needle control member 21, a piston control member 22, a piston ring retainer 23, an injection spring 24, and an outer casing 25.
• the injection syringe 12 comprises a syringe body 26 of generally tubular shape about an injection axis X.
• the syringe body 26 comprises, at its distal end 26D, a distal shoulder 30 carrying an injection needle 32.
• the proximal end 26P of the syringe body 26 comprises a collar 38.
• a piston 40 sliding, of generally cylindrical shape about the axis of injection X, is mounted in the syringe body 26 and allows to inject a liquid product contained in the syringe body 26 by the injection needle 32.
• the piston 40 has a distal end arranged on the side of the liquid product and an opposite proximal end 40P.
• the injection needle 32 is covered with a protective cap 42 of RNS ("Rigid Needle Shield”) type, comprising a soft rubber inner stopper intended to receive the end of the injection needle 32 and to to ensure closure, the inner cap being surrounded by a shell of rigid plastic material conferring good mechanical strength to the inner plug.
• This protective cap 42 has a generally cylindrical shape around the injection axis X, and may have a diameter greater than that of the syringe body 26 and, at the end of the stroke, which bears on the distal shoulder 30.
• the injection syringe 12 is, in this example, a pre-filled syringe glass, needle stuck, having a capacity of 1 mL (milliliter). Note that the syringe body 26 defines a maximum volume of liquid reception, but that it is possible to fill only partially, advancing the piston 40 to the distal end 26D of the syringe body 26.
• the syringe holder 14 is generally tubular in shape around the injection axis X, it is open at both ends and is intended to receive the injection syringe 12.
• the support syringe 14 is thus a single piece, distinct from two half-shells assembled to one another.
• the syringe holder 14 is configured to house the injection syringe 12 so that it is fixedly mounted in the syringe holder 14 throughout the operation of the automatic injection device 10.
• the syringe holder 14 has one end. 14D distal disposed on the side of the injection needle 32 and an opposite 14P proximal end.
• the syringe holder 14 has, at its proximal end 14P, an internal clearance 44 delimited by an internal shoulder, making it possible to receive the collar 38 of the syringe body 26 when the injection syringe 12 is inserted into the syringe holder 26.
• Such internal clearance 44 allows the proximal end 14P to have an inside diameter greater than the rest of the syringe holder 14, and thus to receive, on the one hand, the collar 38, on the other hand a ring 50 for positioning the piston rod 19, these two elements having a larger diameter than the syringe body 26.
• the proximal end 14P of the syringe holder 14 also has an external shoulder 45, complementary to the inner shoulder 44.
• This outer shoulder 45 forms a locking relief of the needle control member 21. More specifically, the outer shoulder 45 makes it possible to hook the needle control member 21 on the proximal end 14P of the syringe holder 14 at the time of assembly of a proximal assembly with a distal assembly of the device. automatic injection 10 and until the end of the insertion of the injection needle 32 into the skin of the patient.
• Two axial notches 48 are also arranged facing each other in the wall of the proximal end of the syringe holder 14. These axial notches 48 allow cooperation with the ring 50 for positioning the piston rod 19 shown in particular in Figures 11 and 13.
• the outer shoulder 45 further comprises a recess 49 forming an axial guide rail for a guide rib 108 of the needle control member 21.
• Each viewing window 47 is of elongate shape and extends substantially in the direction of the injection axis X and makes it possible to make the injection syringe 12 visible when it is inserted into the syringe holder 14. This also allows the user to see that there is liquid product in the injection syringe 12.
• the syringe holder 14 comprises, on an inner face of its wall that can be in contact with the injection syringe 12, a damping element 58 made of elastomeric material, presenting itself for example in the form of an elastomeric strip extending axially and also having a centering rib function.
• damping elements 58 are angularly distributed on the inner face of the syringe holder 14. They are intended firstly to center the injection syringe 12 when it is housed in the syringe holder 14, on the other hand to absorb a portion of the pressure exerted on the injection syringe 12 during the activation of the automatic injection device 10. Moreover, they contribute to the axial blocking of the injection syringe 12 in the syringe holder 14, in particular when advance the injection syringe 12 to perform the insertion and during the pressure exerted by the piston 40 on the injection syringe 12 during injection.
• the elastomeric material is for example an elastomeric thermoplastic material (TPE), preferably injected or overmolded.
• the syringe holder 14 has, at its distal end 14D, on either side of the viewing windows 47, retaining means of the end sleeve 16 on the syringe holder 14, having two radial projections 52 on the outer face of the syringe holder 14, substantially opposite each other.
• Each radial projection 52 has, on its distal face, a ramp 55 intended to cooperate with the end sleeve 16 during its assembly snap on the syringe holder 14.
• the distal end 14D of the syringe holder 14 also comprises holding tabs 53, more precisely four holding tongues 53 extending axially, distributed angularly along the distal contour of the syringe holder 14.
• Each retaining tab 53 has a beveled surface 54 intended to cooperate with the end sleeve 16 when the latter is in the injection position.
• the distal end of the syringe holder 14 also comprises means for guiding the end sleeve 16 on the syringe support 14. These guide means comprise a raised guide shape, namely two guide rods 56 that are integral with each other. with the syringe holder 14, extending on either side of the outer wall of the syringe holder 16, along the axis of injection X.
• the guide rods 56 are intended to cooperate each with a guide shape complementary hollow, namely a slide 57 (visible in Figure 6) and provided on the end sleeve 16, comprising a passage slot to allow guiding during the relative movement of the end sleeve 16 and the syringe holder 14
• Each slideway 57 has a distal portion defining a housing for receiving one of the protective springs 15a or 15b.
• the springs 15a, 15b once released, can each exert a force on one of the guide rods 56 to allow the relative sliding of the end sleeve 16 and the syringe holder 14, the springs protection 15a, 15b being springs in compression.
• the distal end 14D of the syringe holder 14 further comprises two notches 60 for the passage of attachment tabs 66 formed on the removal member 18 of the protective cap 42
• the notches 60 are axially aligned with the retaining means 52.
• the protective cap removal member 42 forms the distal end of the automatic injection device 10. It is intended to be removed from the automatic injection device 10 beforehand. activation of it.
• the removal member 18 has a generally frustoconical shape around the injection axis X, open at both ends, the proximal diameter greater than the distal diameter.
• the distal end of the withdrawal member 18 further comprises, around its distal opening 62, gripping means by a user comprising a flared base 64, further allowing the automatic injection device 10 to stand upright when it is placed on a horizontal support.
• the removal member 18 comprises two attachment tabs 66 of the protective cap 42.
• each latching lug 66 has a proximal ramp 68 for cooperation with the external lateral wall of the protective cap 42 during the insertion of the injection syringe 12 into the syringe holder. 14, and an outer ramp 70 for cooperation with the end sleeve 16 on which the removal member 18 is mounted.
• Each attachment lug 66 further includes a shoulder 72 intended to cooperate with the proximal edge of the protective cap 42 of the injection syringe 12 and allowing its removal when a user pulls axially su 18.
• each external ramp 70 allows, when a user pulls axially on the withdrawal member 18, in cooperation with the end sleeve 16, to tighten the latching lug 66 against the protective cap 42.
• withdrawal member 18 is adapted to drive the protective cap 42 when removed from the automatic injection member 10.
• the withdrawal member 18 is removably attached to the distal end of the end sleeve 16, and thus itself forms a means for gripping the protective cap 42 (as illustrated in FIG. 26).
• the withdrawal member 18 also has, on either side of the attachment lugs 66, on the internal face of its wall, two lugs 74 for cooperation with the end sleeve 16.
• the end sleeve 16 forms, after removal of the withdrawal member 18, the distal end of the automatic injection device 10. It is thus intended to be in contact with the skin of a patient during the injection.
• the end sleeve 16 is attached to the distal end 14D of the syringe holder 14. It is slidably mounted relative to the syringe holder 14 between an injection position, in which the syringe holder 14 and the 16 end are axially (along X) close together, and a protective position in which the syringe holder 14 is axially distally away from the end sleeve 16.
• the sliding of the end sleeve 16 relative to the support syringe 14 is made possible by the cooperation of the slides 57 formed in the inner wall of the end sleeve 16 and guide rods 56 carried by the outer wall of the syringe holder 14, forming means of cooperation between the sleeve of the syringe 14. end 16 and the syringe holder 14.
• the end sleeve 16 has a generally frustoconical shape around the injection axis X, open at both ends, the proximal diameter being greater than the distal diameter.
• the end sleeve 16 comprises two retaining stops 76, each being carried by an elastic tab 78.
• Each elastic tab 78 extends axially (along X) from the distal end towards the proximal end of the end sleeve 16, protruding from the inner surface of the end sleeve 16.
• the two elastic tabs 78 are symmetrical relative to each other with respect to an axis of symmetry passing through the injection pin X.
• each elastic tab 78 extends axially (along X) and has a proximal end having a surface extending in a substantially radial plane, this surface forming a stop 76 of axial retention of the injection syringe 12, preventing the injection syringe 12 from moving towards the distal end of the automatic injection device 10 inadvertently.
• Each elastic tab 78 is deformable between a constricted position, configured to retain axially (in X) in the distal direction the injection syringe 12 in the syringe holder 14, and a spaced position, configured to allow axial insertion (according to X) in the distal direction, from the proximal end of the syringe holder 14, the injection syringe 12 provided with the protective cap 42.
• the retaining tabs 53 of the syringe holder 14 hold the elastic tabs 78 in a constricted position, the retaining tabs 53 thus preventing the resilient tabs 78 from being moved apart and thus preventing the injection syringe 12 from retreating (to the proximal end of the automatic injection device 10).
• the end sleeve 16 when the end sleeve 16 is in the injection position, it envelopes the retaining tabs 53, so as to prevent spacing of the holding tabs 53 induced by a spacing of the elastic tabs 78.
• the end sleeve 16 furthermore comprises, at its proximal end, means for retaining the end sleeve 16 on the syringe holder 14, comprising two proximal windows 80 intended to to serve as a guide for sliding the two radial projections 52 of the syringe holder 14, which are assembled in the proximal windows 80 by snapping.
• the proximal end of the end sleeve 16 further comprises, on its outer side wall, two projecting lugs 82 (see Figures 5 and 6) radially intended to cooperate with the positioning control member 20 to hold it in place.
• the end sleeve 16 further comprises, on the distal portion of its inner wall, means for retaining the the withdrawal member 18, comprising two cavities 84 intended to cooperate by clamping or latching with the two lugs 74 of the withdrawal member 18 (see Figures 6 and 7).
• means for retaining the the withdrawal member 18, comprising two cavities 84 intended to cooperate by clamping or latching with the two lugs 74 of the withdrawal member 18 (see Figures 6 and 7).
• the end sleeve 16 also has, on the distal portion of the its inner wall, on either side of the two cavities 84, means for guiding the withdrawal member 18 comprising two axial slides (along X) 86. It is understood that the end sleeve 16 is attached around the distal end of the syringe holder 14, so that the syringe holder 14 is slidable within the end sleeve 16.
• the piston rod 19 makes it possible to transmit a pressure on the piston 40 in order to inject the liquid product. It comprises, as shown in Figure 12, a distal end 19D, oriented towards the piston 40 and intended to be in contact with the proximal end 40D of the piston 40, during the injection in particular.
• This distal end 19D of the piston rod 19 has a cross section having a polarizing contour, more precisely a non-circular contour.
• the piston rod 19 further has a proximal end 19P, opposite to the distal end 19D, configured to cooperate with the piston control member 22 activated by the injection spring 24.
• the proximal end 19P of the rod piston 19 is of generally cylindrical shape around the injection axis X and comprises four radial projections 87, angularly distributed around the injection axis X, intended to cooperate with the piston control member 22.
• two sliding grooves 88 are formed in the piston support 19, substantially opposite each other and diametrically opposed. Each sliding groove 88 may, for example, be formed by an axial groove. These two sliding grooves 88 extend axially (along X) along the piston rod 19 and define the polarizing outline of the cross section. These sliding grooves 88 are intended to cooperate with an alignment cam of the positioning ring 50.
• the piston rod 19 furthermore comprises, on its distal end 19D, a distal abutment 90 of axial retention of the positioning ring. 50, more precisely two distal stops diametrically opposed.
• the distal stop 90 is formed by a transverse groove formed in each of the sliding grooves 88.
• the positioning ring 50 illustrated in FIG. 11, is intended to cooperate with the piston rod 19 to allow both a good axial and angular positioning of the piston rod 19, and to prevent the withdrawal of the piston rod 19 from the operating ring 50, or even the automatic injection device 10.
• the axial positioning ensures a correct position relative to the piston 40 on the one hand and the piston control member 22 on the other.
• the angular positioning not only prevents the piston rod 19 from rotating on itself during the activation of the piston rod 19 but also provides a predefined angular orientation with respect to the syringe holder 14, allowing abutment axial and then an axial release of the piston rod 19 and the piston control member 22, these configurations being implemented following a rotation of the piston control member 22 relative to the rod of piston 19.
• the positioning ring 50 is intended to be attached to the proximal end 14P of the syringe holder 14.
• the positioning ring 50 comprises angular setting means 98 of the positioning ring 50 on the proximal end 14P of the syringe holder 14.
• These angular wedging means 98 may for example comprise pins ex wedges for insertion into the axial notches 48 of the syringe holder 14, as shown in FIG. 13 or FIG. 26.
• the axial positioning means of the piston rod 19 formed on the positioning ring 50 comprise a axial retaining stop 94 of the piston rod 19, here carried by an elastic tab 96 extending axially from a proximal washer 50P to a distal end 50D of the positioning ring 50.
• the positioning ring 50 comprises two diametrically opposed elastic tabs 96, each carrying an axial retaining stop 94, which is formed in this example by an axial retaining pin of the piston rod 19.
• Each axial retaining stop 94 prevents, by cooperation with a corresponding distal stop 90 of the piston rod 19, that the latter can not be entirely removed (by traction in the proximal direction) of the positioning ring 50 before assembly, and the injection syringe 12 after assembly.
• the means for axial positioning of the piston rod 19 on the positioning ring 50 are furthermore arranged so that, in the storage configuration of the automatic injection device 10, there is a clearance between the distal end 19D of the rod. 19 and the proximal end 40P of the piston 40, preferably a clearance between 0.5 and 2 mm, for example close to 1 mm, as shown in Figure 14.
• the positioning ring 50 further comprises means angular positioning of the piston rod 19 on the positioning ring 50, comprising a passage opening 92 of the piston rod 19 having a complementary polarizing contour of that of the distal end 19D of the piston rod 19. In this way, the passage opening 92 provides a defined and controlled angular positioning of the piston rod 19 with respect to the positioning ring 50 throughout the operation of the automatic injection device 10.
• FIG. 2 shows the positioning control member 20, which comprises two parts, two half-shells intended to be snapped together around the syringe holder 14 by latching means 100 comprising various notches and lugs.
• the positioning control member 20 thus has a generally X-axis tubular shape.
• the distal end of the positioning control member 20 is provided with means for retaining the end sleeve 16, comprising a locking window. 101 intended to cooperate with the two protruding lugs 82 of the outer side wall of the end sleeve 16 (see Figure 6).
• This locking window 101 has a bayonet shape to allow assembly of the end sleeve 16 and the positioning control member 20 by a slight rotation.
• the positioning control member 20 also comprises first and second cam paths 102 and 104 intended to cooperate respectively with first and second positioning control cams 46, 106 respectively carried by the needle control member 21 ( Figure 15) and the piston controller 22 ( Figure 16).
• first and second positioning control cams 46, 106 respectively carried by the needle control member 21 ( Figure 15) and the piston controller 22 ( Figure 16).
• the first cam path 102 has a portion that is more inclined than the rest of the first cam path 102, namely inclined at about 45 °, which allows a progressive advance of the needle. injection 32 at the beginning, and thus limits the pain of the patient.
• the advancing speed of the injection needle 32 can be adjusted by changing the inclination of the first cam path 102.
• the needle control member 21 has a generally tubular shape, as can be see it in Figure 15. At its proximal end 21 P, it comprises temporary coupling means 112 with complementary coupling means 114 carried by the piston control member 22 ( Figure 16), so that the organ 21 and the piston control 22 are integral in motion at the beginning of the thrust exerted by the injection spring 24.
• the injection spring 24 begins to push the piston control member 22, it also pushes the needle control member 21 which, being at this stage also coupled to the syringe holder 14, will push the syringe holder 14 in the distal direction, and thus allow insertion of the injection needle 32 in the patient's skin 11.
• the temporary and complementary coupling means 112, 114 comprise two complementary parts having a mutual attachment shape, for example two axially extending inverted hooks, the first carried by the proximal end 21 P of the needle control 21 and the second carried by the distal end 22D of the piston control member 22.
• the needle control member 21 comprises a guide rib 108, axial, projecting from the inner surface of the needle control member 21, and at its distal end 21 D, a locking pin 107 projecting from its inner surface and having a funnel-shaped shape, the thin portion of the funnel being oriented on the side distal.
• the locking pin 107 is intended to cooperate with the outer shoulder 45 of the proximal end 14P of the syringe holder 14.
• this outer shoulder 45 forms a locking relief of the needle control member 21 at the beginning. operation of the automatic injection device 10, during the insertion of the injection needle 32 into the skin of the patient. As mentioned above, the outer shoulder 45 thus makes it possible to hook the needle control member 21 on the proximal end 14P of the syringe holder 14 at the time of assembly of the proximal assembly with the assembly.
• the needle control member 21 further comprises, on its outer surface and on its distal end 21 D, the first cam 46 intended to cooperate with the first cam path 102 formed in the positioning control member 20.
• the piston control member 22 visible in particular in FIG. 16, has a generally tubular shape. It is configured to apply a force on the piston 40 (via the piston rod 19), under the action of the injection spring 24. That is, the piston control member 22 is intended to transmit the action of the injection spring 24 to the piston 40, more particularly via the piston rod 19. This force allows the axial displacement (along X) of the piston 40 in the distal direction of the device automatic injection 10, to inject the liquid product into the skin of the patient.
• the piston control member 22 carries a stop 118 which can be retracted between an active configuration for retaining the injection spring 24 in the compressed state and a retracted configuration for releasing the injection spring 24.
• the organ control 22 comprises two diametrically opposed semi-flexible semi-annular elastic tabs 116, each carrying a retractable stop 118 intended to cooperate with the member of the locking member of the outer casing 25.
• Each of the semi-annular elastic tabs 116 carrying the retractable stops 118 extends axially (along X) towards the proximal end of the automatic injection device 10, each semi-annular elastic tab 116 thus being deformable between a radially spaced rest configuration giving the retractable abutment 118 its configuration active and a radially retracted configuration giving the retractable stop 118 its retracted configuration.
• Each semi-annular elastic tab 116 of the piston control member 22 further having a longitudinal window 120 allowing deformation to facilitate the assembly of the injection spring 24 and the retaining ring 23 of the injection spring 24 around the two semi-annular elastic tabs 116.
• each retractable stop 118 is radially spaced when it is in its active configuration. This allows in particular each retractable stop 118 of the piston control member 22 to take a radially projecting position. Furthermore, each retractable stop 118 is radially retracted when it is in its retracted configuration, in particular to take a radially retracted position.
• the piston control member 22 has, at its distal end 22D, a generally cylindrical shape carrying the complementary coupling means 114 and the second cam 106, and delimiting a proximal shoulder 115, external, forming a seat for the spring of injection 24.
• This proximal shoulder 115 is also traversed by orifices, extending towards the proximal end 22P so as to form axial slots 119.
• the piston control member 22 is configured to be rotatable relative to the piston rod 19 between a thrust configuration, during which it abuts against the radial projection 87 and exerts a thrust on the piston rod 19, and a configuration the release of the piston rod 19, in which it is not in abutment against the radial projection 87 and releases a passage, formed by the axial slots 119 so that the piston rod 19 can retract in the proximal direction.
• the retaining ring 23 serves to retain the injection spring 24 in the compressed state. More precisely before the injection, the injection spring 24 is maintained in its compressed state by means of the retractable stop 118 carried by the control member of the piston 22, cooperating with a complementary surface carried by the retaining ring 23. In other words, the retractable stop 118 in active configuration abuts against a complementary surface carried by a retaining ring 23 of the injection spring 24.
• This retaining ring 23 is attached to the proximal end 20P of the positioning control member 20. For this purpose, it has two lugs 121, external and diametrically opposed, for setting the retaining ring 23 intended to cooperate with complementary notches of the positioning control member 20.
• the end distal of the retaining ring 23 also forms a proximal seat for the injection spring 24, and the proximal end forms a complementary abutment surface for the abutment retractable 118.
• the injection spring 24 is the main engine of the injection. Also, it must have sufficient force to be able on the one hand to penetrate the injection needle 32 in the body of the patient, on the other hand to move the piston 40 in the syringe body 26 to inject the liquid product. Its strength is preferably greater than 20 Newton or 50 Newton or 80 Newton for a relatively viscous liquid product or for a syringe / needle section high ratio. This injection spring 24 is deformable between a compressed state before use of the automatic injection device 10 and a relaxed state after injection of the liquid product contained in the syringe body 26.
• the spring injection 24 is maintained in its compressed state by means of the retractable stop 118 carried by the control member of the piston 22, cooperating with a complementary surface carried by the retaining ring 23.
• This retractable stop 27 is indeed retractable between an active configuration for retaining the injection spring 24 in the compressed state, corresponding to a radially protruding position for retaining the injection spring 24 and a retracted configuration for releasing the injection spring 24 allowing it to relax.
• the outer casing 25 is the part which, in this example, envelops most parts of the automatic injection device 10. It allows in particular that these parts of the automatic injection device 10 are isolated from the outside.
• the outer casing 25 also comprises a locking member 122 of the retractable abutment 118 in its active configuration, provided in the proximal end of an outer casing 25 of the automatic injection device 10.
• This locking member 122 can assume a locking position, in which it exerts pressure on the retractable stop 118 to prevent it from taking its retracted configuration, and an unlocking position in which the retractable stop 118 is free to take its retracted configuration. More precisely, as can be seen in FIG.
• the proximal end 25P of the outer casing 25 comprises a radial surface, recessed (in two distinct orifices, facing each other) in the vicinity of an unlocking pin 124 so as to be traversed by the semi-annular elastic tab 116 of the piston control member 22 carrying the retractable stops 118 at least when the locking member 122 is in the locking position.
• the locking pin 122 comprises two axially distributed segments (along X) and of different diameters, namely a locking section 126 and an unlocking section 128.
• the locking section 126 has a radial dimension which is greater than a radial dimension of unlocking section 128 if we consider an axial section passing through the retractable stops 118, so that the locking section 126 exerts a radial pressure on the retractable stops 118 when the locking member 122 is in the locking position.
• the unlocking section 128 creates, in turn, a clearance space retractable stops 118 when the locking member 122 is in the unlocked position.
• the locking section 126 and the unlocking section 128 are distally offset relative to one another.
• the locking member 122 also carries a ramp 130 intended to cooperate by ramp effect with the semi-annular elastic tabs 116 of the piston control member 22 carrying the retractable stops 118, to move them from their active configuration to its retracted configuration.
• the unlocking section 128 is distally at least partially facing the ramp 130.
• the automatic injection device 10 presents itself to the user in the form of a tube of about ten centimeters long. Only the outer casing 25 and the removal member 18, or the end sleeve 16 if the removal member 18 is removed, are visible and accessible to the user.
• a first operating step consists in holding the protective cap removal member 18 with one hand and the outer casing 25 with the other hand and pulling on the withdrawal member 18 along the injection pin X in a distal direction.
• the axial traction movement activates the outer ramp 70 of each latching lug 66, tightening the two latching lugs 66 against the protective cap 42, favoring the contact between the shoulder 72 of each latching lug 66 and the latch 66.
• Proximal rim of the protective cap 42 Proximal rim of the protective cap 42.
• the end sleeve 16 shaped the distal end and the automatic injection device 10 is ready to be used.
• the injection needle 32 is set back in the end sleeve 16, 3 mm (millimeters), to prevent accidental puncture.
• the distal end of the end sleeve 16 is placed against the skin of the patient 11, where the injection of the medical liquid contained in the injection syringe 12 is desired. This step is followed by an unlocking step, during which a slight axial pressure is applied, in the distal direction, on the outer casing 25.
• the unlocking step is followed by a step of triggering the automatic injection, during which the user continues the axial pressure on the outer casing 25 by pressing on the skin of the patient 11, in the continuity of the axial pressure started during the unlocking step.
• This additional pressure generates a compression of the protective springs 15a, 15b which allows, in the first place, an axial connection (along X) of the end sleeve 16 and the syringe holder 14.
• the end sleeve 16 slides further inside the outer case 25 towards its proximal end, generating additional sliding, inside the outer casing 25 and towards the proximal end of the outer casing 25, the positioning control member 20 and the piston control member 22.
• the retractable stop 118 carried by the piston control member 22 slides towards the proximal end of the outer casing 25, which generates its retraction out of the engagement of the retaining ring 23, by ramping effect between the retractable abutment 118 and the proximal surface of the outer casing 25, so that the injection spring 24 is released.
• the release of the injection spring 24 triggers a series of cascading reactions which result in the penetration of the injection needle 32 into the patient's body and the injection of the liquid product contained in the syringe body 26. It will be noted that the stroke of the injection needle 32, during these operations, is 9 mm, so that the injection needle 32 exceeds about 6 mm, corresponding to the depth of injection into the skin of the patient 11.
• the injection spring 24 thrusts in the distal direction on the piston control member 22 which is, at this stage, coupled with the needle control member 21 due to the entanglement of the means of The displacement of the needle control member 21, being integral with the syringe holder 14 via the outer shoulder 45, generates the displacement in the distal direction of the syringe holder 14.
• the injection syringe 12 is mounted integral with the syringe holder 14, the injection syringe 12 is also pushed towards the distal end of the automatic injection device 10 and the injection needle 32 springs out of the sleeve of end 16.
• This axial connection of the end sleeve 16 and the syringe holder 14 is by sliding between, on the one hand, the radial projections 52 of the syringe holder 14 in the proximal windows 80 of the end sleeve 16 and , otherwise rt, the guide rods 56 in the gutters 57 of the end sleeve 16.
• This axial reconciliation is illustrated in Figures 27 (before insertion of the injection needle 32) and 28 (after insertion of the needle of injection 32).
• the cooperation between the first and second cams 46, 106 of the needle control 21 and piston control members 22 with the corresponding first and second cam paths 102 , 104 of the positioning control member 20 independently controls the penetration of the injection needle 32 into the skin of the patient 11 and the injection of the medical liquid contained in the syringe body 26.
• the mechanism of successive couplings comprising a coupling at first time of the injection needle 21 and piston 22 control members, and a second coupling of the piston control member 22 and the t piston rod 19, makes completely independent the penetration of the injection needle 32 and the injection, that is to say that it is necessary to reach the right depth of injection needle 32 before starting the injection, which avoids incorrect injection.
• the syringe holder 14 rises freely in the piston control member 22, due to the rotation of the latter 22 which allowed to align the radial projections 87 of the piston rod 19 with the axial slots 119, thereby releasing a passage for the piston rod 19 to retract relative to the piston control member 22 in the proximal direction.
• the syringe holder 14 is thus axially remote from the end sleeve 16, and the injection needle 32 is retracted into the end sleeve 16, thus avoiding any risk. of injury.
• the two protective springs 15a, 15b can freely relax, they are no longer subjected to the force exerted by the injection spring 24 and generate a protective position in which the syringe holder 14 is axially remote from the sleeve of end 16, resulting in the retraction of the injection needle 32 in the end sleeve 16, thus avoiding any risk of injury.
• the injection syringe 12 is pressurized, it is retained within the automatic injection device 10 while the pressure exerted on the proximal end of the injection rod piston 19, so on the piston 40, can be consistent.
• FIG. 28 during the entire duration of the injection, it is the cooperation between the distal shoulder 30 of the injection syringe 12 and the two retaining stops 76 carried by the elastic tabs 78. end sleeve 16 which holds the injection syringe 12, that is to say that it is the distal end of the injection syringe 12 which receives the stress from the injection spring 24 applying the piston 40.
• the elastic tab 78 of the sleeve end 16 provides the axial retention (along X) of the injection syringe 12 in the distal direction of the automatic injection device 10 so that the pressure exerted by the injection spring 24 on the piston rod 19 during the injection causes pressure on the distal end of the injection syringe 12, but does not generate pressure at the flange 38 of the injection syringe 12.
• the collar of an injection syringe being a fragile area, the risk of breakage of the injection syringe 12 are thus greatly reduced and the injection spring 24 can be chosen from very rigid springs, allowing for example the injection of very viscous products, up to 100 CP and / or the use of injection needles 32 of diameter reduced.
• the flange can be supported on an elastic ring allowing the bulk of the axial pressure to be collected by the distal end of the injection syringe, thereby decreasing the pressure on the patient. body of the syringe at the level of the collar.
• the end sleeve 16 envelops the four holding tongues 53 of the syringe holder 14, so as to prevent spacing of the holding tongues 53 induced by a gap of the elastic tab 78 under the effect of the pressure exerted by the shoulder distal 30 of the injection syringe 12 on the retaining stops 76.
• the holding tongues 53 are held in their tightened position by the proximal portion of the end sleeve 16.
• the assembly of the automatic injection device 10 comprises four main steps:
• a first step for this comprises the interlocking of the end sleeve 16 with the withdrawal member 18, by snapping the lugs 74 into the cavities 84.
• the attachment lugs 66 of the withdrawal member 18 slide in the slides axial 86 of the end sleeve 16 until claws 74 snap into the cavities 84.
• the step is followed by a detent step of the syringe holder 14 with the end sleeve 16, through the interlocking radial projections 52 (thanks to to the ramps 55) of the syringe holder 14 in the proximal windows 80 of the end sleeve 16.
• the protective springs 15a, 15b are threaded onto the guide rods 56 before snap-fitting of the syringe holder 14 and the end sleeve 16 and held in place by snapping the two pieces together.
• proximal subset For this purpose, the positioning control member 20, the needle control member 21, the piston control member 22, the retaining ring 23, the injection spring 24 and the outer casing 25 are assembled. More specifically, the injection spring 24 is firstly assembled on the proximal end of the control member of the piston 22, by keeping it compressed by cooperation of the retaining ring 23 with the retractable stop 27 carried by the piston control member 22. Then these elements are placed in one of the two half-shells of the positioning control member 20, by additionally adding the needle control member 21 in the coupling position with the piston control member 22.
• the second half-shell of the positioning control member 20 is then attached to the first half-shell, and then the outer casing 25 is threaded around these elements, ending the assembly by snapping the distal end ale of the outer casing 25 and that of the positioning control member 20, this snapping nevertheless leaving the possibility of axial sliding, allowing the positioning control member 20 to move back relative to the outer casing 25.
• a third subset is assembled, called an intermediate subset.
• This subassembly comprises the piston rod 19 provided with the positioning ring 50.
• the automatic injection device 10 is assembled by inserting, into the distal subassembly, the injection syringe 12, by inserting the latter into the syringe holder 14 from its proximal end. During this insertion, as the end sleeve 16 and the syringe holder 14 are in axially distant position, the end sleeve 16 does not wrap the four holding tabs 53 of the syringe holder 14, which are thus free to deviate radially during the passage of the protective cap 42 of the injection syringe 12.
• the elastic tabs 78 of the end sleeve 16 are, in cooperation with the cap of protection 42 held in their spaced apart position, thereby allowing insertion into the distal direction, from the proximal end of the syringe holder 14, of the injection syringe 12 provided with the protective cap 42.
• the invention is not limited to the embodiments presented and other embodiments will become apparent to those skilled in the art.
• the positioning ring 50 is assembled while being in the retracted position on the piston rod 19, then the piston rod 19 is screwed on and the positioning ring 50 is then slid to be wedged onto the support syringe 14 and activate the axial positioning means.

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• Health & Medical Sciences (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Fuel-Injection Apparatus (AREA)

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• 2015
  • 2015-07-24 FR FR1557075A patent/FR3039069B1/fr not_active Expired - Fee Related
• 2016
  • 2016-07-22 EP EP16753412.2A patent/EP3325050A1/fr not_active Withdrawn
  • 2016-07-22 WO PCT/FR2016/051912 patent/WO2017017360A1/fr active Application Filing
  • 2016-07-22 CN CN201680049128.4A patent/CN107921209A/zh active Pending
  • 2016-07-22 JP JP2018503494A patent/JP2018520805A/ja active Pending
  • 2016-07-22 BR BR112018001390A patent/BR112018001390A2/pt not_active Application Discontinuation
  • 2016-07-22 US US15/747,340 patent/US20180311438A1/en not_active Abandoned

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