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
  • A61M5/30—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
  • 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
  • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
  • A61M5/2046—Media being expelled from injector by gas generation, e.g. explosive charge
• • 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
  • A61M2205/82—Internal energy supply devices
  • A61M2205/8218—Gas operated

Definitions

• the technical field of the invention is that of needle-free injection devices, pre-filled and disposable, operating with an energy source such as for example a gas generator, and used for intradermal, subcutaneous and intramuscular injections.
• liquid active ingredient for therapeutic use in human or veterinary medicine.
• the active ingredient consists of a more or less viscous liquid, a mixture of liquid, or a gel.
• the active ingredient may also be a solid dissolved in a solvent suitable for injection or consist of a powdery solid suspended at a certain concentration in a suitable liquid. The granulometry of the active ingredient must then be compatible with the diameter of the ducts to avoid closing them.
• An injection device comprises in known manner, as for example in the patent application FR-A-2815544 (equivalent to WO 02/34317), a body successively comprising a gas generator, an expansion chamber, a reservoir containing the liquid active ingredient and an injection system.
• the reservoir consists of a glass tube which is inserted into the body of the device and which is sealed by an upstream piston stopper and a downstream piston stopper between which the liquid active ingredient is contained.
• the free end of the tank cooperates with an injection nozzle which comprises at least one injection channel extending axially along an injection axis.
• the gas generator is designed to generate a pressurized gas which drives the piston plugs in motion to inject the active ingredient through the patient's skin through the injection nozzle.
• the injection device comprises a hollow cap which envelops the body and which delimits a lower opening adapted for the passage of the injection nozzle.
• the free end of the injection nozzle which projects out of the body and the hood is protected by a removable cap and a cap which houses the lid.
• bottle shape means a shape comprising a first portion of a first section and a second portion of a second section, the first section. being greater than the second section.
• the nozzle further comprises a connecting portion configured to connect the first and the second portion in a gentle inclination, for example 45 ° relative to the axis of the nozzle and whose corners are rounded.
• such a nozzle shape has a coherence length of the jet of non-optimal active ingredient relative to the pressure exerted on the active ingredient.
• the present invention aims to solve all or part of the disadvantages mentioned above.
• the present invention relates to an injection nozzle for a needleless injection device comprising an outlet channel extending along an injection axis, the at least one outlet channel comprising:
• first channel portion of a first section a first channel portion of a first section; a second channel portion of a second section, the first section being greater than the second section;
• the connecting portion being inclined at an angle of between 70 ° and 90 ° with respect to the injection axis.
• the coherence length of the fluid jet is improved.
• the current lines are oriented so as to be substantially parallel to each other over a greater distance, allowing better penetration and propagation of the product in human tissues.
• the output fluid velocity is substantially 10% greater than a bottled form, at equal pressure.
• the bottle shape generally limits the pressure losses and thus optimizes the fluid velocity.
• the arrangements according to the invention also make it possible to limit the consequences of a manufacturing defect.
• a connecting portion strongly inclined relative to the injection axis is easier to achieve and less expensive.
• the arrangements according to the invention make it possible either to obtain a better jet performance at the outlet of the injection nozzle with a pressure generated by the identical gas generator or to maintain identical performances of the jet of fluid at the outlet of the nozzle. lowering the pressure to be exerted by the gas generator, and thus save energy.
• the connecting portion is perpendicular to the injection axis. This arrangement makes it possible to improve the performance of the fluid jet at the outlet of the injection nozzle;
• the connecting portion forms a shoulder between the first channel portion and the second channel portion.
• a shoulder is less sensitive to manufacturing defects than the bottle form;
• the first section has a diameter of between 0.8 and 1 millimeter, preferably 1 millimeter. The diameter of the first section and allows the proper operation of the device while limiting the size of the injection nozzle;
• the second section has a diameter of between 0.3 and 0.45 millimeters, preferably 0.4 millimeters.
• a ratio between the first section and the second section between 0.35 and 0.45, preferably equal to 0.4;
• the length of the second channel portion is between 0.5 and 1.5 millimeters. This arrangement allows a sufficient length to straighten the streamlines of the fluid and short enough not to generate a pressure drop;
• the nozzle comprises a support configured to receive the at least one channel to maintain the channel in the injection device.
• the present invention further relates to a needleless injection device comprising:
• a piston arranged to be actuated by the gas generator
• a reservoir configured to receive a fluid to be injected, the piston being configured to eject fluid out of the reservoir; at least one injection nozzle according to any one of the aforementioned characteristics, fluidly connected to the reservoir, configured to guide the fluid out of the injection device.
• the reservoir and the piston are arranged in the injection axis.
• the pressure exerted by the gas generator is between 100 and 300 bar.
• the fluid contained in the reservoir comprises an active ingredient chosen from the group comprising the following active ingredients:
• FIG. 1 is an axially exploded perspective view, which illustrates a needleless injection device
• FIG. 2 is a detail view in perspective of FIG. 1, which illustrates an injection nozzle comprising exit channels according to the invention
• FIG. 3 is a transverse axial sectional view of the injection device
• FIG. 4 represents an output channel profile of the prior art, in the form of a bottle
• FIG. 5 represents an output channel profile according to the invention.
• the longitudinal, vertical and transverse terminology will be adopted in a nonlimiting manner with reference to the L, V, T trihedron indicated in the figures.
• FIG. 1 shows a needleless injection device 10, or needleless syringe, which comprises a U-shaped body 12 successively comprising a percussion device 14, a primer 16, a pyrotechnic charge 18, these three elements constituting a gas generator 20, an expansion chamber 22, a reservoir 24 containing a fluid comprising an active ingredient 26 and an injection system 28.
• the gas generator 20 constitutes a first linear subset of the body 12 which extends axially along a first vertical axis A, and the reservoir 24 containing the active ingredient 26 and the liquid injection system 28 form a second subset linear body 12 which extends axially along a second vertical injection axis B.
• the reservoir 24 is constituted by a glass tube 30 sealed by an upstream piston plug 32 and a downstream piston plug 34 between which the active liquid substance 26 is contained, the piston plugs being made of elastically deformable material based on elastomer.
• the reservoir 24 is inserted into the body 12 and is blocked vertically, on the one hand, at its upstream portion by the body 12, via a cylindrical piece 36 of flexible material, such as rubber, and provided with a central opening opening on an elastic bag 37.
• the elastic bag is in fluid communication with the expansion chamber, the gas is then arranged to penetrate into the pocket which then extends by elasticity and thus allows the cap to be moved. piston upstream 32. Thus, the gas does not communicate with the active ingredient.
• the tank 24 is blocked vertically at its downstream portion by an injection nozzle 38.
• the nozzle 38 seen in more detail in FIGS. 2 and 4, has a cylindrical shape along the injection axis B which is delimited by a peripheral cylindrical face 40 provided with a thread, the thread being designed to cooperate with a tapping. complementary formed on the inner wall of the downstream end of the body 12.
• the nozzle 38 comprises from one to three outlet channels 42, parallel to the injection axis B and arranged in a support 39.
• the body 12 is enveloped by a hollow cover 46 which defines a lower opening closed by a sole plate 48 forming a hood bottom.
• the soleplate 48 defines a circular passage 50 around the injection axis B which is adapted for the passage of the injection nozzle 38 and the downstream end of the body 12, so that the nozzle 38 has a lower section. 52 protruding vertically downward from hood 46.
• the injection device 10 is equipped with a plug 54 which is delimited vertically by an upper face 56 open resting on the soleplate 48 of the cover 46, and a bottom face 58 closed generally flat.
• the plug 54 defines a generally tubular housing which extends axially along the injection axis B and which opens into the lower face 58 of the plug 54 by forming a circular passage 60 closed by a disc 62 of removable bottom.
• the bottom disk 62 comprises six clamping tabs 64 which extend axially parallel to the injection axis B, from an upper face 66 of the disk 62.
• the disk 62 comprises four resiliently deformable teeth 68 each adapted to cooperate with an internal annular groove 70 formed by the plug 54.
• the plug 54 is pivotally mounted about the injection axis B between a closed position in which the plug 54 is positioned in the extension of the cover 46, so that the plug 54 and the cover 46 form a smooth homogeneous shell, and an open position in which the cap 54 is angularly rotated about 60 degrees about the injection axis B.
• the plug 54 In its closed position, the plug 54 is locked to the rest of the injection device 10. Conversely, in its open position, the plug 54 is adapted to be removed from the rest of the device 10 to allow access to the nozzle 38 and to perform an injection.
• the injection device 10 comprises a first bayonet type locking means adapted to lock the cap 54 on the body 12 of the device 10, during the driving of the plug 54 between its open position and its closing position.
• the output channels 42 comprising a first channel portion 90 of a first section 91 and a second portion of
• SUBSTITUTE SHEET RULE 26 channel 92 of a second section 93.
• the first section 91 being greater than the second section 93.
• the channels 42 further comprise a connecting portion 94 between the first channel portion 90 and the second channel portion 92.
• the portion connection 94 is substantially transverse, that is to say has an inclination with respect to the injection axis B between 70 ° and 90 °, preferably between 80 ° and 90 ° and preferably is perpendicular to the injection axis B.
• the coherence length of the jet of active ingredient is improved.
• the current lines are oriented so as to be substantially parallel to each other over a greater distance, allowing better penetration and propagation of the product in human tissues.
• the speed of the active ingredient at the outlet is substantially greater than 10% with respect to a bottled form, represented in FIG. 4, at equal pressure.
• the bottle shape generally limits the pressure losses and thus optimizes the fluid velocity.
• the consequences of a manufacturing defect are also limited.
• a connecting portion 94 strongly inclined relative to the injection axis B is easier to perform and less expensive.
• the connecting portion 94 forms a shoulder between the first channel portion 90 and the second channel portion 92.
• a shoulder is less sensitive to manufacturing defects than the bottle form.
• the first section 91 has a diameter of between 0.8 and 1 millimeter, preferably 1 mm. The diameter of the first section 91 thus allows the injection device 10 to function properly while limiting the bulk in the injection device.
• the second section 93 has a diameter of between 0.3 and 0.45 millimeters, preferably 0.4 millimeters. These provisions allow an optimal ratio between the first section 91 and the second section 93.
• the length of the second channel portion 92 is between 0.5 and 1.5 millimeters. This arrangement allows a length sufficient to straighten the fluid flow lines and short enough not to generate a pressure drop.
• the channels 42 are for example polycarbonate.
• SUBSTITUTE SHEET RULE 26 The user unlocks the injection device by removing the cap 54 by a rotation in one direction or the other. It applies the free end of the nozzle 38 against the skin of the patient to be treated and, by pressing a finger, it drives the cover 46 which slides along the body 12 until the trigger of the gas generator 20. pressure exerted by the gas generator is between 100 and 300 bar.

Landscapes

• Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• General Health & Medical Sciences (AREA)
• Hematology (AREA)
• Engineering & Computer Science (AREA)
• Vascular Medicine (AREA)
• Heart & Thoracic Surgery (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Nozzles (AREA)
• Medicinal Preparation (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Applications Claiming Priority (2)

Publications (1)

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ID=58162711

Family Applications (1)

Country Status (13)

Families Citing this family (2)

Family Cites Families (29)

• 2016
  • 2016-10-11 FR FR1659833A patent/FR3057169B1/fr active Active
• 2017
  • 2017-10-02 BR BR112019007287-0A patent/BR112019007287B1/pt active IP Right Grant
  • 2017-10-02 CA CA3039921A patent/CA3039921A1/fr active Pending
  • 2017-10-02 EP EP17792112.9A patent/EP3525845A1/fr active Pending
  • 2017-10-02 RU RU2019107485A patent/RU2749568C2/ru active
  • 2017-10-02 IL IL265816A patent/IL265816B2/en unknown
  • 2017-10-02 WO PCT/FR2017/052701 patent/WO2018069600A1/fr unknown
  • 2017-10-02 KR KR1020197013603A patent/KR102546081B1/ko active IP Right Grant
  • 2017-10-02 AU AU2017341413A patent/AU2017341413B2/en active Active
  • 2017-10-02 CN CN201780062385.6A patent/CN109803700B/zh active Active
  • 2017-10-02 MX MX2019003879A patent/MX2019003879A/es unknown
  • 2017-10-02 JP JP2019540707A patent/JP2019531172A/ja active Pending
• 2019
  • 2019-04-11 US US16/381,584 patent/US11712521B2/en active Active
• 2022
  • 2022-06-03 JP JP2022091077A patent/JP2022119971A/ja active Pending

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