Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
• • 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
  • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2006—Piercing means
  • A61J1/201—Piercing means having one piercing end
• • 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
  • A61M5/1782—Devices aiding filling of syringes in situ
• • 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
  • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
• • 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
  • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
  • A61M5/3007—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules with specially designed jet passages at the injector's distal end
• • 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
  • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
  • A61M5/347—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw
• • 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
  • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
  • A61M5/348—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub snap lock, i.e. upon axial displacement of needle assembly
• • 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
  • A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile

Definitions

• the present invention relates to a device for the needleless subcutaneous injection of a drug in liquid form and, more particularly, to such a device of the type which comprises a) an injection head consisting of a tubular body delimiting a chamber capable of containing a volume of said medicament, said tubular body being closed, at one end, by a transverse wall traversed by at least one microchannel opening onto an external face of the head designed to be applied to the skin of a patient and, at the other end, by a piston movable axially ** in said chamber, b) means for filling the chamber and c) means for acting on said piston to force said medicament out of the injection head, through said microchannels.
• a device of this type is known from international patent application WO 95/24176, this request being more particularly centered on the means designed to fill the chamber of the injection head with a volume of the drug to be administered.
• these means essentially comprise an apparatus 1 formed of a tubular cylindrical body 2, furnished with a cartridge 3 filled with medicament, said cartridge being equipped at one end with a piston 4 which can slide in the cartridge 3 under the thrust of an operating rod 5 projecting from one end of the body. At its other end, the cartridge 2 is closed by a cover 6.
• the body 2 is closed, at its end opposite the end 5, by a sleeve 7 axially crossed by a hollow needle 8 projecting inside the tubular body 1.
• a first position (not shown in FIG. 1), the cartridge 3 is moved away from the tip of this needle 8, which then does not pass through the cover 6.
• the cartridge is pushed towards the needle 8 which pierces this seal to penetrate the cartridge while pressing against the sleeve 7, as shown in FIG. 1.
• applying an axial thrust on the rod 5 - for controlling the piston 4 the contents of the cartridge 3 are emptied into the injection head, through the needle 8.
• the filling means described in WO 95/24176 are adapted to an injection head comprising, for discharging its content after filling, a nozzle pierced with a single channel, the medicament being forced through this channel so as to form a jet clean medicine to penetrate under the skin of a patient by its only living force. It is through this single channel that the injection head is filled, the diameter of this channel being ordinarily very small, of the order of a few hundred microns for example. It is understood that this small diameter limits the flow of the drug in the injection head during filling thereof, which can then be long.
• a needleless injection head comprising, like the head 9 shown in FIG.
• a tubular body 10 delimiting a chamber 11 suitable for containing a volume of the medicament, this body 10 being closed at one end.
• a transverse wall 12 traversed by a plurality of microchannels such as 13 ⁇ , 13 2 , .... oriented parallel to the axis X of the injection head, these channels opening onto an external face 14 of the head 9 designed for be applied to the skin of a patient to administer the medicament contained in chamber 11.
• the injection head 9 is closed by a piston 15 movable along the axis X in the chamber 11.
• a propellant mechanism can receive the injection head 9 for suddenly driving the piston 15 towards the wall 12 of this head, thereby forcing the liquid contained in the head through the microchannels 13 and the skin of a patient, attached to the external face of this wall, the filling device 1 then being obviously separated from the injection head.
• the means for filling a single microchannel injection head of the type described in WO 95/24716 cited above are not suitable for ensuring rapid filling of a multiple microchannel head of the type shown in FIG. attached drawing.
• the object of the present invention is precisely to provide a device for the needleless subcutaneous injection of a medicament in liquid form comprising means for filling an injection head of said medicament which does not have the drawbacks of the the prior art and which, in particular, ensures rapid filling of said head.
• the means for filling the head of this device comprise means for temporarily closing at least one microchannel for injecting the drug and at least one passage passing through the wall of the injection head and designed to cooperate with a medicament cartridge to allow the filling of the head with a volume of medicament coming from the cartridge, this passage being equipped with a non-return valve means opposing any leakage of said drug out of said head, through said passage.
• this passage can be dimensioned so as to allow rapid filling of the injection head, contrary to what is observed when one fills this head through the microchannel (s). injection of the drug under the skin of a patient.
• FIGS. 1 and 1A represent an embodiment of the device according to the invention, already partially described in the preamble to this description, and
• FIG. 1 of the appended drawing represents, assembled in line on the X axis, the device 1 for filling an injection head 9 mounted on this device, and the propulsion mechanism 16 with reset.
• manual designed to actuate the injection head 9 of the device according to the invention during the administration of a medicament contained in this head. It is clear that during this actuation, the filling device 1 must be removed from the head to allow the application thereof, by its external face 14, on the skin of a patient, who is then in the outlet of the microchannels 13i, these can also take the form of microfentes. Similarly, during filling of the head 9 the propellant mechanism 16 is not mounted on this head.
• This propellant mechanism 16 provides the injection under the skin of a patient of the drug, previously loaded in the chamber 11 of the head 9 by the filling means according to the present invention which will be described later in detail.
• the propellant mechanism essentially comprises a cylindrical tubular body 17 in which slides a ram 18 loaded by a spring 19. Balls 20 ⁇ , 20 2 , ... loaded by springs 21 ⁇ , 2l 2 , ... in a groove dug on the outer surface of the body 10 of the injection head 9, make it possible to removably fix the latter on the propellant mechanism 16.
• the ram 18 can be locked in a high position, from the point of view of FIG. 1, spaced from the head 9 , by means not shown.
• Pressing a trigger button 23 releases the ram 18 which, under the pressure of the compressed spring 19, is thrown suddenly towards the piston 15 of the head 10 without compressing the (non-tight) volume of intermediate air 24, to expel constant speed the piston 15 of the head 9 towards the bottom of the latter.
• the medicament contained in the chamber 11 then exits at constant pressure from the chamber in a sprayed form, and penetrates under the skin of a patient applied against the surface 14 of the head, in place of the device for filling this head shown in Figure 1.
• the present invention relates specifically to new means put in place to allow rapid filling of the head 9 with the drug to be administered in spray form.
• these means comprise means 25 for temporarily closing the microchannels 13i, a passage 26 passing axially, and in the central position, the wall 12 of the injection head and, between the ends of this passage 26, a housing 27 shaped to receive a tongue 28 (see FIG. 1A) of complementary shape.
• the socket 7 mounted on the filling device 1 comprises an axial nozzle 29 which projects from the bottom of this socket to pass through the passage 26 and open into the chamber 11 of the head 9 when the latter is mounted on this socket. to be filled with medicine.
• the nozzle 29 is, for this purpose, crossed axially by the needle 8.
• the microchannels of the head 9 are advantageously distributed symmetrically around the axis of symmetry of this head.
• they may be two or more and have a diameter of 100 to 300 ⁇ m, in a ratio of 1/20 to 1/100 with the diameter of the chamber 11.
• a certain relationship is chosen between the diameter of the microchannels and the diameter of the cylindrical internal chamber 11 containing the liquid solution of the medicament, to guarantee the spraying and not the formation of a painful concentrated spray.
• This ratio is between 1/20 and 1/100 while remaining imperatively in the linear zone of the propellant mechanism and to maintain a small footprint at the injection head in order to guarantee the possibility of traditional manufacture.
• the microchannels are no longer oriented to form an angle between them, and must necessarily remain perpendicular on the one hand to the internal face of the chamber 11 and on the other hand to the planar external face 14 of the head d injection which is in contact with the patient's skin, and be strictly parallel to each other.
• microchannels have a length equivalent to 5 to 10 times their diameter to avoid bursting at the time of injection and any risk of injury.
• microchannels must be perfectly cylindrical in order to guarantee at their output a perfect quality of spraying, well aligned. That 8
• the operations of filling this head with a volume of medicament then operate as follows.
• the apparatus 1 being separated from the head, an axial pressure is exerted on the operating rod 5 of the piston 4 of the cartridge 3 of medicament placed in the apparatus 1 to bring the seal 6 of this cartridge into contact with the needle 8 which then pierces the cover, as we saw above.
• the axial movement of the cartridge 3 stops when the cartridge abuts against the sleeve 7.
• the medicament fills the needle 8 by expelling the air which is there.
• the head 9 is then put in place on the sleeve 7 of the filling device 1.
• the sleeve 7 comprises for this purpose elastic claws 30 ⁇ , 30 2 , ... which engage with an annular shoulder formed on the head injection 9.
• the sealing means 25 are installed on the bottom of this socket to close the microchannels 13 ⁇ , 13 2 while the nozzle 29 passes through the passage 26.
• the piston 15 of the latter then passes from an initial position in which it bears on the bottom of the chamber, in contact with the nozzle 29, to a final position defined by the amount of medication received. By proceeding in this way, it is ensured that the chamber 11 contains only the medicament and not furthermore parasitic air.
• the medicament injected into the chamber 11 cannot come out of it by the microchannels 13 ⁇ , 13 2 . It is understood that the quantity of medicament injected into the chamber 11 can be adjusted precisely by various known means such as, for example, a micrometric adjustment of the stroke of the piston 4 in the cartridge 3.
• the head 9 can also be transparent and graduated to this effect.
• the tongue 28 is inserted, according to the present invention, into the housing 27 so as to prevent the medicament contained in the chamber from coming out by passage 26, now closed by this tab, which thus constitutes a non-return member.
• the wall 12 of the head 9 is hollowed out with a transverse passage of cross section conforming, in the plane of the drawing, to that of the tongue 28, this passage constituting the accommodation 27.
• closure means 25 are maintained on the outer ends of these microchannels.
• These means can then take the form of a cover made of a peelable adhesive film, pressed on the face 14 of the injection head. In this case, this cover can be put in place before the head filling operations. It is then removed just before the drug is administered. The presence of this seal also responds to hygiene requirements.
• This diameter D can then be chosen so that this loading is made as fast as desired.
• the diameter D can be of the order of a millimeter, while the diameter of the microchannels 13 ⁇ , 13 2 is of the order of 100 to 300 ⁇ m.
• FIGS. 1,1A makes it possible to achieve the desired goal. It will be noted, however, that the use of a removable tongue 28, which must be installed in the head after filling thereof, makes this embodiment of use fairly delicate. The use of such a tab can also pose sealing problems during the injection of the medicament, due to the high pressure then prevailing in the chamber 11.
• FIG. 2A the tongue 28 of the embodiment of FIG. 1 is replaced by a non-return valve 32 shown in more detail in FIG. 2A where it appears that this valve comprises a central leg 33 and a flexible transverse skirt 34.
• the central foot is designed to be forced into the passage 26, its skirt 34 being pressed against an internal face of the end wall 12 of the injection head 9, under the pressure of the drug contained in chamber 11.
• this skirt 34 is flexible and capable of being lifted from this internal face under the pressure of the 11
• the foot 33 carries grooves such as 35 ⁇ , 35 2 , ... providing between them passage spaces for the medicament around the foot 33, according to a well-known arrangement for this type of valve.
• the medicament pushed into the needle 8 in the direction of the arrow F by an apparatus of the type of the apparatus represented in FIG. 1, can it pass into the chamber 11 after having passed through the valve 32.
• the valve 32 opposes any reflux of the drug through the central passage 26.
• the microchannels 13 ! , 13 2 are moreover closed by means 25 similar to those described in connection with FIG. 2.
• This variant makes it possible to speed up the filling operations and possibly facilitate their automation, because they suppress the operation of inserting the tongue 28 of the embodiment of FIGS. 1,1A, after the filling of the chamber 11.
• flap valves having the required tightness at high pressures prevailing in the chamber 11 of the head 9 during the injection of the medicament.
• valve 32 identical to that which equips the variant of Figure 2, is introduced into a passage 26 'pierced, not in the bottom 12 of the head 7, but along the axis of the piston 15.
• the nozzle 29 is then modified in order to be able to hang on to the piston 15 during the filling operations. It is, for this purpose, provided with a ring of elastic claws 36 ⁇ , 36 2 , ... adapted to hang, removably, to a groove dug in a housing 12
• the nozzle 29 can deliver a volume of medicament which enters the chamber 11 by a mechanism similar to that described in connection with FIGS. 2,2A.
• a plug 38 fitted with shutter means 25 is then applied against the face 14 of the head 9.
• FIG. 3 makes it possible to simplify the structure of the wall of the head 9, the arrangements necessary for the reception of the non-return valve being transferred to the piston 15.
• the invention is not limited to the embodiments described and shown which have been given only by way of example.
• the invention although described in its application to an injection head comprising a plurality of microchannels, is obviously applicable to an injection head comprising only one microchannel for injecting the drug.
• non-return valves other than those described above, ball valves for example, could be used. It is thus also that one could substitute for the tongue 28 of FIG. 1 a tongue made of a self-healing material. This tab is permanently installed on the head, before the implementation of the filling operations of this head.
• a needle of the type of needle 8 pierces the self-healing tongue to allow a flow of drug in the head.
• the needle is withdrawn from the tongue which "heals" automatically, preventing any backflow of the liquid.
• the cartridge can be replaced by a bottle containing the liquid medicine or by any other packaging, the sleeve 7 then being adapted accordingly.
• an appropriate automation makes this repetitive operation at a high rate in order to obtain injection heads preloaded at predetermined dose and delivered in sterile packaging. It is also possible to control by transparency the volume of medicament entering the internal chamber 11 if the injection head 9 is transparent and graduated like a syringe. This simplifies its filling.
• a molded injectable material is used to make this head.
• the head can be made of steel and sterilized before use. The valve remains disposable and interchangeable. According to another characteristic of the invention, in certain applications encountered in particular in the particular and specific field of vaccination, the total passage through the skin is no longer sought.
• a microfente can have a width of between 10 ⁇ and 500 ⁇ , a length of between 100 ⁇ and 5000 ⁇ and a depth of between 100 ⁇ and 5000 ⁇ .

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

Applications Claiming Priority (3)

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ID=9523549

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• 1998
  • 1998-03-03 FR FR9802514A patent/FR2775603B1/fr not_active Expired - Fee Related
• 1999
  • 1999-03-03 CA CA 2321906 patent/CA2321906A1/en not_active Abandoned
  • 1999-03-03 EP EP99937880A patent/EP1064036A1/de not_active Withdrawn
  • 1999-03-03 WO PCT/FR1999/000476 patent/WO1999044658A1/fr not_active Application Discontinuation
  • 1999-03-03 AU AU32575/99A patent/AU3257599A/en not_active Abandoned

Non-Patent Citations (1)

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