EP3706572A1 - Dispositif d'injection cryorésistant prêt à l'emploi - Google Patents
Dispositif d'injection cryorésistant prêt à l'emploiInfo
- Publication number
- EP3706572A1 EP3706572A1 EP18842429.5A EP18842429A EP3706572A1 EP 3706572 A1 EP3706572 A1 EP 3706572A1 EP 18842429 A EP18842429 A EP 18842429A EP 3706572 A1 EP3706572 A1 EP 3706572A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- cap
- injection
- breakable
- base
- needle
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
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- 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
- A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
-
- 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
- A61M5/3129—Syringe barrels
- A61M5/3134—Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0205—Chemical aspects
- A01N1/021—Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
- A01N1/0221—Freeze-process protecting agents, i.e. substances protecting cells from effects of the physical process, e.g. cryoprotectants, osmolarity regulators like oncotic agents
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0236—Mechanical aspects
- A01N1/0263—Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
- A01N1/0268—Carriers for immersion in cryogenic fluid, both for slow-freezing and vitrification, e.g. open or closed "straws" for embryos, oocytes or semen
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
-
- 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
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/06—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
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3202—Devices for protection of the needle before use, e.g. caps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
- A61M5/344—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub using additional parts, e.g. clamping rings or collets
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- 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
- A61M5/5086—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 for indicating if defective, used, tampered with or unsterile
-
- 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
- A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
- A61M2005/3104—Caps for syringes without needle
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- 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
- A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
- A61M2005/3106—Plugs for syringes without needle
-
- 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
- A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
- A61M2005/3107—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle for needles
- A61M2005/311—Plugs, i.e. sealing rods or stylets closing the bore of needles
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- 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
- A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
-
- 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
- A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
- A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
- A61M2005/312—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
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- 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
- A61M5/3129—Syringe barrels
- A61M2005/3131—Syringe barrels specially adapted for improving sealing or sliding
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- 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
Definitions
- the present invention relates to a device for injecting a liquid form kept cold, such as in particular biological products or drugs, of animal or human origin, frozen. More particularly, the present invention relates to the field of injection devices, syringe type, especially ready for use.
- Some pharmaceuticals need to be kept frozen, even cryogenised, to ensure proper preservation of their pharmacological and pharmacodynamic properties. They are often placed, to be frozen or cryogenized, in ampoules, bags, vials or capsules containing a dose to be administered. This is the case in particular, products comprising cells. For these fragile products, it is not conceivable to have to decondition the product, after thawing or decryogenization, to inject it afterwards. This type of manipulation generates risks, contamination, cell losses, etc.
- WO 2016/019108 discloses a cryoresistant vial comprising a tube and two caps, located at each end, which allow to free a space for a piston and a needle.
- the vial can therefore be converted into a syringe.
- the deconditioning of the device requires many manipulations, including the unscrewing plugs and the establishment of a piston, a base and a needle.
- this solution does not ensure that a previous manipulation was not made on the bottle which does not guarantee maximum safety vis-à-vis a possible contamination of the solution.
- WO 2007/044980 describes a device for injecting a dose of drug and / or cells stored at a temperature below -40 ° C.
- the device comprises modular elements to deliver a thawed solution to be administered by a syringe after a few manipulations.
- it is necessary to transfer the thawed liquid into a reservoir of the syringe.
- the device described in document WO 2007/044980 thus imposes a manipulation of the liquid to be administered from one chamber to another for its administration.
- a disadvantage of this solution is to present a device requiring manipulations exposing the liquid to the risk of contamination after thawing before obtaining a ready-to-use syringe.
- Another disadvantage results from the many manipulations imposing a precaution and vigilance of an operator maintained on each of the preparation steps of the syringe. Whatever the manipulations envisaged, they require an adapted environment in order to reduce the risks inherent to them.
- EP 2 253 349 describes a cryoresistant syringe for the injection of a liquid medicament comprising a cylindrical body, a cap having a sealing member and a piston.
- the syringe described imposes additional manipulations before the injection of the drug since it is necessary to remove the sealing member of the cap before adapting the needle on the cylindrical body of the syringe.
- EP 2 554 205 discloses a cryoresistive medical device for injecting a medical agent solution.
- This device comprises an outer cylinder, a plug and a piston head.
- the cap comprises a portion percutable by a needle to allow the injection of the solution contained in said device.
- This solution proves fragile since the percutable portion can be pierced inadvertently and accidentally before using the device.
- WO 2009/086829 discloses a breakable storage container for the release of a solution after adaptation of a needle.
- the container comprises a tubular body and two plugs closing each end of the tubular body.
- the container body is breakable in several places for the release of the solution contained in said body, making it particularly fragile.
- the container does not include a piston for injection of the solution.
- US 2006/019233 discloses an apparatus for the cryopreservation of biological materials such as a sealed syringe for injecting a solution.
- the syringe comprises a body, a first cap and a piston head on which a piston can be fitted.
- the device described imposes additional manipulations before the injection of the biological material since it is necessary to remove the cap before adapting the needle on the cylindrical body of the syringe.
- the injection device according to the invention makes it possible to meet these two requirements of a ready-to-use and cryoresistant device.
- One of the many advantages of the invention is therefore to allow administration of a thawed liquid form by minimizing the number of manipulations and therefore the risks (leakage, contamination, cell loss).
- the object of the invention is also to propose a non-reusable single-use device, this ensures a safety vis-à-vis the solution thanks to the closure of the two ends of the injection body.
- the invention relates to a cryoresistant device for injecting a solution, this device comprising an injection body, a plug, a piston head; the injection body has a proximal first end sealingly closed by the plunger head and a second distal end sealingly closed by the stopper; the stopper is held in the injection body by a fixing and has a breakable portion releasing a base for the introduction of a needle.
- the cap comprising a breakable portion is a breakable cap, the separation of a breakable portion releasing a means for attaching an injector having a needle. Due to the presence of a closed cap for which a break (or break) must be engaged, the risk of loss of content and the risk of leakage is avoided.
- the solution of the invention allows a gain of safety due to the presence of a closed plug for which a breakable element provides sealing and insulation. The solution of the invention thus allows a maximum level of security.
- the solution also offers an economic gain due to the possibility of using a common injector and saving time compared to other systems.
- the device according to the invention further comprises a cap sealingly sealing the first proximal end of the injection body.
- the seal is added to the piston head to ensure a completely hermetic closure of said first proximal end of the injection body. It also protects the piston head against unintended handling. It can be for example aluminum.
- the injection body may be made of polypropylene.
- the piston (head, rod and / or pusher) and / or the seals may be made of silicone, PTFE (Poly tetra fluoroethylene) or adapted TPE (Thermoplastic elastomer) of a hardness appropriate to each use.
- PTFE Poly tetra fluoroethylene
- TPE adapted TPE (Thermoplastic elastomer) of a hardness appropriate to each use.
- An advantage of PTFE is to be particularly adapted to the very big cold especially for its use with mechanical parts.
- the means for attaching an injector to the plug is a base adapted to the introduction of a needle.
- the plug base comprises an adaptation means such as a thread or a guide arranged on a circumferential portion.
- This thread is adapted to cooperate with a base of an injector comprising a needle, said base comprising a complementary matching means adapted to an inner or outer circumferential portion.
- the adaptation means may be a thread, a guide such as a circular rail, or any other shape to fit a complementary shape of the plug base.
- the plug base is of the Luer Lock type.
- the adaptation means such as a thread may be arranged on the inner surface of the base of an injector.
- the breakable portion is a breakable tip.
- the breakable cap comprises a base and a breakable tip, which may, in one embodiment, form a rod extending said base; the base is integral with the injection body; in one embodiment, the breakable cap further comprises a filter for filtering the liquid form to be injected.
- the base or the periphery of the base of the breakable cap is integral, preferably welded, at one end of the injection body.
- the base or the periphery of the base of the breakable cap can be secured to one end of the injection body by definitive clipping, or any other means known to those skilled in the art. The final clipping means that once clipped on one end of the injection body, the base can no longer be removed from said end.
- the plug comprises a cryoresistant seal.
- the breakable stopper is cryoresistant to -196 ° C.
- the invention relates to an injection assembly comprising: (i) a cryoresistant device according to the invention, for the injection of a solution comprising a breakable stopper, (ii) an injector, (iii) a piston rod and (iv) a piston plunger; said injector comprising a needle, a needle holder, a base secured to the support and adapting to the plug of the device according to the invention, after section of the breakable portion.
- the piston rod and plunger are configured to cooperate with the piston head of the device.
- An advantage of the invention is to have a cryoresistant device which is independent of the injector. It is therefore not necessary to store the cryopresistant device with the injector, which leads to a saving of space for the storage of cryogenic solutions.
- the injector comprises a protective cap
- the needle comprises a single or multiple bevel at its distal end and / or a single or multiple bevel at its proximal end, intended to be placed on the base breakable cap after separation of the breakable portion.
- the invention relates to a process for preparing a ready-to-use cryoresistant single use device being a process for preparing a liquid form to cryogenize.
- the method comprises the following steps:
- a liquid form into the device of the invention, consisting of the injection body, the piston head and a cap which have been assembled preferably under sterile conditions;
- the invention relates to a method for preparing a liquid form to be injected comprising the following steps:
- ⁇ "cryoresistant” refers to a room or solution resistant to cold and especially at very low temperatures, for example below 150 ° C.
- ⁇ "lug” means a projection on the surface of a manufactured object that makes it possible to form a retaining stop or a retaining stop of a mechanical part.
- ⁇ "operculum” means a protective element, most often forming a consumable element. It may be for example a cover or a protective pad.
- ⁇ "bevel” means a profile forming the end of a sharp or piercing object.
- a bevel can be made by inclining the end of the object, such as a needle. It usually refers to the sharp or piercing part of a sharp tool.
- FIG. 1 represents an example of an injector adapted to cooperate with a stopper according to the first embodiment or the second embodiment.
- Figure 2 shows a piston comprising a pusher, a rod and a head.
- FIG. 3 shows an example of a plug having a breakable tip according to a second embodiment.
- FIG. 4 represents an example of a syringe associated with a stopper according to the invention.
- FIG. 5 represents an example of a filter cooperating with the plug of FIG.
- Figure 6 shows the body of a syringe of Figure 5 having a sealing member for the preservation of the syringe.
- lid of the syringe body cooperating with the overflow surface 21 plug intended to be associated with a syringe body
- the invention relates to a stopper 21 intended to be associated with a body 1 of a syringe.
- injection device and a "syringe”.
- injection assembly means the injection device or the syringe to which an injector 4 is associated.
- injection body is used interchangeably. and a "syringe body”.
- the plug 21 is intended to be secured to the syringe body 1 in order to maintain and maintain a solution to administer in a sealed manner.
- the stopper 21 may be of a diameter substantially equal to the diameter of the syringe body 1.
- the cap 21 When the syringe is ready to be used after a period of preservation, the cap 21 has a breakable portion to release a base 210.
- the base 210 can then be associated with an injector 4 to inject the solution.
- One embodiment describes a plug 21 comprising a breakable element 211, this mode is described in particular through Figures 3, 4, 5 and 6.
- the plug 21 does not include a percutable element that can be pierced or struck by a needle.
- the injector 4 of Figure 1 is compatible with the plug 21 breakable according to whether we consider the various possible cooperation between the base 43 of the injector 4 and the base 210 of the plug 21, for example of the type "Luer Lock ".
- Other bases may be used according to other embodiments from the moment when the injector 4 has a fastening for securing it with the syringe (also called injection device).
- the body 1 is made of a polymer such as, for example, polypropylene or Cyclo Olefin Co-polymer (COC), which makes it possible to ensure cryoresistance up to at least a temperature of -130.degree. C., -40.degree.
- the body 1 is preferably cryore resistant to at least a temperature of -196 ° C.
- An advantage of COC is to be a transparent cryoresistant material.
- the plug 21 is made of polymer such as for example polypropylene or Cyclo Olefin Co-polymer (COC).
- the frangible plug is cryoreistant to at least a temperature of -30 ° C, -40 ° C, -15 ° C, -165 ° C, -170 ° C, -185 ° C, -195 ° C, or -l96 ° C.
- the stopper 21 is preferably cryore resistant to at least a temperature of -196 ° C.
- An advantage of COC is to be a transparent cryoresistant material.
- the elements of the device in contact with the solution to be injected comprise at least one biocompatible material, free of heavy metals, material of animal origin or releasing chemicals.
- the injector 4 comprises a needle 41, a needle support 42 designed to hold the needle 41 and a base 43.
- the base 43 is integral with the needle holder 42.
- the support 42 and the base 43 are made of the same material and form a single piece.
- the base 43 has an external thread to cooperate with the internal thread of the Luer-Lock tip. According to other embodiments, the base 43 of the injector 4 comprises a fixing means allowing to be secured to a tip of the plug 21.
- the first end of the needle 41 is arranged substantially in the center of the base 43 and is driven with the translation movements of G injector 4 when the latter is fitted on the injection body 1.
- the needle 41 comprises at its second end a second bevel 410 to provide optimized penetration.
- the needle 41 has at its second end a second bevel 410 to provide better penetration of the needle 41 in the skin.
- the injector 4 comprises a cap 45 to protect the needle 41.
- the needle 41 is in this case not presented directly, it is necessary to remove the cap 45.
- the cap 45 makes it possible to fix the injector 4 to the cap 21 in a simple manner, for example by holding the cap 45 between its fingers.
- the injector 4 can be screwed, clipped or engaged on the plug 21.
- the cap 45 prevents contamination of the needle 4L
- the plug 21 comprises a Luer Lock type nozzle.
- the tip comprises an internal thread cooperating with an external thread of a base 43 of an injector 4.
- the tip is a luer-lock tip of ISO 594 / 1-1986, NF EN 20594-1: 1993-12.
- G injector 4 comprises a needle 41 with beveled double entry.
- the injector 4 comprises a needle 41 with a single beveled entry, the single inlet being used for the injection.
- Figure 3 shows a plug 21 according to a second embodiment.
- the plug 21 comprises a breakable portion 211.
- the breakable portion 211 forms a hollow or solid rod extending over a portion of a few centimeters.
- the section of the breakable portion can be facilitated and can be achieved by a fold engaged with the fingers.
- the stem is hollow, it is sealed at its end farthest from the injection body 1.
- the rod has at least one zone of weakness on a circumferential portion so as to cause a break in a predetermined region.
- the zone of weakness is a notch of a circumferential portion or stripe.
- the notch or scratch is made so that breakage, breakage or breakage is generated at the base of the rod at its junction with the base 210. The notch or scratch creates a breaking edge allowing to easily break the rod. The notch or scratch allows a uniform break on the entire circumference of the rod, and avoids the production of debris resulting from the break.
- the notch is a stripe applied by a lining of the rod.
- the lamination is carried out all around the stem, or on a portion of the periphery of the rod, so that the notch or scratch extends over the entire periphery of the rod, or on a portion of the perimeter of the stem.
- the notch is made by a "color break" method which consists of depositing a material having a coefficient of expansion different from that of the material of the rod at the point where the rod should break. .
- the notch is made by an "Anrep” method which consists in heating the material of the rod in a very localized way in order to generate internal tensions in the material of the rod and, consequently, weakens it.
- the notch or scratch is made by any method known to those skilled in the art.
- the rod is broken by the application of a breaking force consisting of a pair of forces of opposite directions and perpendicular to the direction of the rod.
- the rod is held stationary during the application of said breaking force.
- the rod is self-breaking, that is to say that it is not necessary to use any tool, such as a file for example, to break the rod.
- the rod is a tube, a cylinder of circular section, ovoid, or a parallelepiped.
- the rod has a length ranging from 0.5 cm to 5 cm. According to one embodiment, the rod has a diameter ranging from 0.5 mm to 5 mm. According to one embodiment, the rod has a side section ranging from 0.5 mm to 5 mm.
- the rod is made of polymer such as, for example, polypropylene or Cyclo Olefin Co-polymer (COC), which makes it possible to ensure cryoresistance up to at least a temperature of -130.degree. C., -40.degree. 150 ° C., -165 ° C., -170 ° C., -180 ° C., -195 ° C., or -196 ° C.
- the rod is preferably cryoreistant to at least a temperature of -196 ° C.
- the rod is solid on an upper portion and recessed on a lower portion of the cap 21 so that the injector 4 can take a portion of the solution even if the rod is broken a little higher than the base of its junction with the base 210.
- the stopper 21 comprises a base 212 adapted to cooperate with the proximal end of the body of the syringe 1.
- the stopper 21 is permanently attached to the body of the syringe 1. According to one embodiment, the stopper 21 is welded to the syringe body 1.
- the cap 21 is permanently clipped to the body of the syringe 1.
- the fixing of the cap 21 on the injection body 1 comprises at least one tamper pin arranged on a peripheral portion of the injection body 1.
- the cap 21 advantageously comprises a circumferential lug forming a holding member of the cap 21 to the injection body 1 when it is clipped in contact with a clipping lug forming a projection on the surface of the body of injection 1.
- the two pins have complementary geometries to form an assembly forming an action and a reaction in opposition to secure the cap 21 with the injection body 1.
- the clipping cap 21 is fixed to the injection body 1. The seal is then ensured by the presence of the circumferential seal and the holding lug which holds the seal in compression.
- the stopper 21 has a rim extending over a slight portion of the outer surface of the body of the syringe 1.
- the edge extends longitudinally along the injection body 1. This edge reinforces the body-plug connection.
- the holding pin is positioned at the end of this edge.
- the lug covers only a portion of the inner circumference of the cap 21.
- the lug on the injection body 1 also partially covers the circumference of said body 1.
- the two lugs are clipped on one another by deformation of the cap 21 during its adaptation to the injection body 1.
- the plug 21 comprises a base 210 having a thread arranged on its outer surface.
- the base 210 is of the Luer Lock connector type.
- the threading 210 cooperates with a thread of the injector 4.
- the base 43 of the injector 4 comprises an internal thread for cooperating with the threading of the base 210.
- the invention relates to an injector 4 such as that shown in Figure 1 having a base 43 having a means for fitting a connector for example Luer Lock type.
- the base 43 has an external thread and an internal thread.
- the injector 4 also comprises a lid (not shown) closing the base 43 that it is necessary to remove before the fixing of the injector 4 on the plug 21.
- Figure 4 shows a syringe body 1 which is associated with a plug 21.
- a filter 213 is introduced between the plug 21 and the syringe body 1 so as to filter the micro-aggregates and / or microparticles of the liquid form that will be injected.
- Such a filter allows a gain in safety as to the liquid form to be administered, which may for example contain a suspension comprising microaggregates and / or microparticles.
- the filter 213 is of conical shape, this in particular makes it possible to obtain an optimized shape matching the plug 21. According to another example, it is flat.
- the cap 21 also comprises an inner seal forming a contact between the cap 21 and the syringe body 1.
- the cap 21 is welded to the syringe body 1.
- the sealing of the syringe body 1 can be ensured by the fixing of a cap 21 on the syringe body 1 with for example a seal and a weld.
- the syringe body 1 has an end forming an overflow surface 10.
- the overflow surface 10 forms a circumferential rim ergonomic support for injection.
- the overflow surface 10 makes it possible to form a bearing zone when a cover 101 is glued as shown in FIG. 6.
- the cover 101 cooperates with the overflow surface 10.
- the piston 31, formed by a rod 32 and a pusher 30, is used after thawing of the injection device (FIG. 2).
- a piston head 31 may be inserted into the syringe body 1 before freezing or cryogenization of the device, and may comprise means for adapting to a rod 32 and a pusher 30 not shown in FIG. 6
- the integration into the syringe body 1, the piston head 31 and the lid 101 can thus be performed upstream to ensure a good seal of the syringe body 1.
- the lid 101 is removed, thus releasing the distal end of the injection body 1, and the rod 32 and the pusher 30 can be adapted to the piston head 31 to form a piston 3.
- the cover 101 may comprise a barcode or a 2D code comprising an indication on the product contained in the syringe body 1.
- the cover 101 includes information on the type of syringe. injector 4, rod 32 and / or pusher 30 to use or the diameter of the base 43 to be used.
- the lid 101 makes it possible in particular to protect the piston head 31 and the solution to be injected, and to maintain them in conditions that avoid any external contamination or loss of solution (leaks).
- the cap 101 is made of aluminum. According to an exemplary embodiment, they are glued or welded to the end of the body of the syringe 1.
- the cap 101 has a diameter substantially greater than that of the injection body 1.
- a tongue may be used on a cap 101 obstructing the proximal end of the injection body 1.
- the piston comprises a pusher 30 or a pusher element for driving the piston 3 in translation. inside the injection body 1.
- the piston 3 further comprises a rod 32 for driving a head 31 forming a sealing element in order to prevent leakage of the solution included in the injection body 1
- the head 31 preferably comprises a circumference adapted to flow along the inner wall of the injection body 1 while forming a sealed wall.
- the piston head 31 is detachable so as to form a piston 3 without rod and without pusher.
- An interest is to allow to keep the solution with a piston head 31 intended to cooperate with a rod 32.
- a junction 301 allows to penetrate the rod 32 in the piston head 31.
- the interest of not having the rod 32 or the pusher 30 of the piston 3 in the device to cryogenize or freeze is to limit the amount of material to be cryoresistant.
- the pusher 30 and the rod 32 may be consumables put in place during thawing of the device and the solution contained in the injection body 1.
- the plug 21 is leaktight and makes it possible to retain the liquid form in the body of the syringe 1.
- manufacture of the components from medical grade raw materials in accordance with the USP (Class IV) , the European Pharmacopoeia and the ISO 10993 standard is produced according to the invention.
- a cryoresistant material (0 ° C to at least -196 ° C, regardless of the refrigeration means) autoclavable according to standard protocols described in the European Pharmacopoeia can be used.
- a geometry of the Luer-lock connection can be determined according to the standard NF EN 20594-1: 1993-12.
- the size and / or the volume of the variable constituent elements can be chosen according to the needs of 2 to 60 ml.
- the injection body 1 has a cylindrical shape.
- the injection body 1 has a volume of between 2 and 60 ml.
- the injection body 1 has a length of between 4 cm and 15 cm.
- the injection body 1 has a diameter of between 0.5 cm and 5 cm.
- the components of the injection device and / or the injection assembly may be packaged together or separately in a packaging or a suitable dual cryoreistant packaging to isolate the injectable content of the immediate environment .
- the invention also relates to a method for preparing a liquid form to be frozen / cryogenised.
- the process for preparing a liquid form for cryogenising comprises the following steps:
- the liquid form is a solution.
- liquid form and “solution” may be used interchangeably in this specification.
- the cap 21 comprises a frangible breakable type element.
- the step of introducing the liquid form into the device is carried out using a manual or automated filling device for filling the tube.
- the method comprises a preliminary step of assembling the injection body 1, the piston head 31 and the cap 101, during which the piston head 31 is introduced into the injection body 1 by its proximal end and the lid 101 is then glued to seal said proximal end of the injection body 1.
- the step of closing the injection body 1 by fixing a breakable stopper 21 consists of closing said injection body 1 by welding, or definitive clipping of the cap 21 on the distal end of the injection body 1.
- the step of freezing or cryogenizing the injection device is carried out using the most appropriate means for the liquid form. If the liquid form comprises a biological product, this corresponds to the most appropriate means for the biological product.
- the step of freezing or cryogenizing the injection device comprises a programmed freezing step with a temperature step of -1.5 to -2.5 ° C / min.
- the step of freezing the injection device comprising a liquid form comprises cooling said device to a temperature of at least -120 ° C.
- the cryogenization step of the injection device comprising a liquid form comprises cooling said device to a temperature of at least -196 ° C. This step is carried out using liquid nitrogen or nitrogen vapor in which the device is immersed.
- the invention also relates to a method for preparing a liquid form to be injected for administration.
- the method for preparing a liquid form to be injected comprises the following steps:
- the attachment of the injector 4 can be achieved through a thread of a base 210 of a tip of the plug 21 for example of a Luer-lock type element.
- the section of the breakable plug 21 corresponds to a breaking of a breakable element 211.
- the breakable element 211 being removed, a base 210 having a thread is released to fix an injector 4.
- Fixing the injector 4 is simple, fast and requires little manipulation.
- the device of the invention for this fixation has the advantage of allowing direct injection of the solution to be injected. It is therefore not necessary to decondition the liquid form, wash and recondition before injection.
- the method further comprises, after the step of removing the lid 101, a step of adapting a rod 32 and a pusher 30 to the piston head 31 to achieve a 3.
- the volume of liquid form to be injected can be adjusted by means of the piston rod 32 carrying graduations.
- the method further comprises a last step being a step of injecting the liquid form.
- the liquid form can be injected for example into the body of a subject, into a pocket, bottle, container, culture medium or any medium or any type of container known to those skilled in the art.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Vascular Medicine (AREA)
- Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Environmental Sciences (AREA)
- Dentistry (AREA)
- Mechanical Engineering (AREA)
- Otolaryngology (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Pharmacology & Pharmacy (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR1762146A FR3075056A1 (fr) | 2017-12-14 | 2017-12-14 | Dispositif d'injection cryoresistant pret a l'emploi |
PCT/FR2018/053298 WO2019115974A1 (fr) | 2017-12-14 | 2018-12-14 | Dispositif d'injection cryorésistant prêt à l'emploi |
Publications (1)
Publication Number | Publication Date |
---|---|
EP3706572A1 true EP3706572A1 (fr) | 2020-09-16 |
Family
ID=62816601
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP18842429.5A Withdrawn EP3706572A1 (fr) | 2017-12-14 | 2018-12-14 | Dispositif d'injection cryorésistant prêt à l'emploi |
Country Status (7)
Country | Link |
---|---|
US (1) | US20210077732A1 (fr) |
EP (1) | EP3706572A1 (fr) |
KR (1) | KR20200110651A (fr) |
CN (1) | CN111683527A (fr) |
CA (1) | CA3085494A1 (fr) |
FR (1) | FR3075056A1 (fr) |
WO (1) | WO2019115974A1 (fr) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20230064423A1 (en) * | 2020-02-13 | 2023-03-02 | West Pharmaceutical Services, Inc. | Containment and delivery systems for cryogenic storage |
CN113577461B (zh) * | 2021-08-10 | 2022-03-29 | 温州康洲医疗器材有限公司 | 一种自对位型针座 |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4790828A (en) * | 1987-08-07 | 1988-12-13 | Dombrowski Mitchell P | Self-capping needle assembly |
DE69427751T2 (de) * | 1993-03-02 | 2002-05-23 | Seikagaku Kogyo Co Ltd | Eine arznei enthaltende spritze |
DE10247965A1 (de) * | 2002-10-15 | 2004-05-06 | Transcoject Gesellschaft für medizinische Geräte mbH & Co KG | Originalitätsverschluss für eine Spritze |
MX2007000787A (es) * | 2004-07-23 | 2007-03-26 | Amgen Inc | Suministro de una masa celular grande en una jeringa y metodos relacionados de criopreservacion de celulas. |
CA2876618C (fr) | 2005-10-13 | 2018-07-17 | Argos Therapeutics, Inc. | Dispositifs, systemes et procedes associes destines a l'administration d'un medicament liquide stocke a des temperatures cryogeniques |
WO2009055610A1 (fr) * | 2007-10-26 | 2009-04-30 | Cytori Therapeutics, Inc. | Système de seringue pour l'administration régulée ou l'élimination régulée d'un matériau |
CN101959601A (zh) * | 2008-01-07 | 2011-01-26 | 哈维德夫医院 | 储存器皿以及用于分割该器皿的断开工具 |
EP2253349A1 (fr) * | 2008-02-19 | 2010-11-24 | Arte Corporation | Combinaison seringue/contenant |
EP2554205B1 (fr) * | 2010-03-30 | 2020-04-22 | Terumo Kabushiki Kaisha | Dispositif médical pourvu d'un revêtement coulissant, et seringue |
KR101354451B1 (ko) * | 2012-12-03 | 2014-01-28 | 김근배 | 필터 주사기 |
US20170216531A1 (en) * | 2014-07-31 | 2017-08-03 | The Johns Hopkins University | Cryosyringe designed for sterile liquid nitrogen freezing, quick thawing and injection of cellular slurries |
FR3036954B1 (fr) * | 2015-06-03 | 2017-07-14 | Imv Tech | Paillette pour la conservation d'une dose predeterminee de substance a base liquide, ainsi que dispositif d'injection et procede la mettant en oeuvre |
-
2017
- 2017-12-14 FR FR1762146A patent/FR3075056A1/fr not_active Withdrawn
-
2018
- 2018-12-14 WO PCT/FR2018/053298 patent/WO2019115974A1/fr unknown
- 2018-12-14 CN CN201880080653.1A patent/CN111683527A/zh active Pending
- 2018-12-14 US US16/772,229 patent/US20210077732A1/en not_active Abandoned
- 2018-12-14 KR KR1020207020116A patent/KR20200110651A/ko unknown
- 2018-12-14 EP EP18842429.5A patent/EP3706572A1/fr not_active Withdrawn
- 2018-12-14 CA CA3085494A patent/CA3085494A1/fr active Pending
Also Published As
Publication number | Publication date |
---|---|
KR20200110651A (ko) | 2020-09-24 |
CA3085494A1 (fr) | 2019-06-20 |
FR3075056A1 (fr) | 2019-06-21 |
US20210077732A1 (en) | 2021-03-18 |
WO2019115974A1 (fr) | 2019-06-20 |
CN111683527A (zh) | 2020-09-18 |
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