WO2023012335A1 - Ensemble seringue-cartouche - Google Patents

Ensemble seringue-cartouche Download PDF

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Publication number
WO2023012335A1
WO2023012335A1 PCT/EP2022/072090 EP2022072090W WO2023012335A1 WO 2023012335 A1 WO2023012335 A1 WO 2023012335A1 EP 2022072090 W EP2022072090 W EP 2022072090W WO 2023012335 A1 WO2023012335 A1 WO 2023012335A1
Authority
WO
WIPO (PCT)
Prior art keywords
plunger
cartridge
syringe
bendable
barrel
Prior art date
Application number
PCT/EP2022/072090
Other languages
English (en)
Inventor
Erik RYCKALTS
Original Assignee
Roncadelle Operations Srl
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Roncadelle Operations Srl filed Critical Roncadelle Operations Srl
Publication of WO2023012335A1 publication Critical patent/WO2023012335A1/fr

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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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2422—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • 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
    • A61M5/3293—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 characterised by features of the needle hub
    • 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
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • A61M2005/3235—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user triggered by radial deflection of the anchoring parts between needle mount and syringe barrel or needle housing, e.g. spreading of needle mount retaining hooks having slanted surfaces by engagement with correspondingly shaped surfaces on the piston at the end of an injection stroke
    • A61M2005/3238—Trigger provided at the proximal end, i.e. syringe end opposite to needle mounting 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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • A61M2005/3241—Needle retraction energy is accumulated inside of a hollow plunger rod
    • 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
    • A61M2205/8275—Mechanical
    • A61M2205/8281—Mechanical spring operated

Definitions

  • the present invention related to methods and devices for medicinal product administration.
  • the present invention relates to the manufacture of a syringe using cartridges pre-filled with a medicinal product.
  • the present invention relates methods and devices configured to accept medicinal fluid containing cartridges and to dispense said medicinal product through a needle.
  • WO0172362 discloses a hypodermic needle syringe comprising a retraction mechanism, and configured to accept and use needle equipped cartridges.
  • the document discloses three distinct embodiments, which embodiments differ in the type of energy storage and in how retraction force.
  • energy to be converted into a retraction force is stored by means of vacuum inside the proximal end of a piston rod.
  • the same energy is stored by means of a spring inside the proximal end of a piston rod.
  • energy used for the retraction movement is stored in a compression spring located around the cartridge and acting directly upon a radial protrusion located at the proximal end of said cartridge.
  • the position of the cartridge in the injector is held by a flexible tab.
  • the cartridge is provided with hooking means configured to interact with a compatible radial extension on the piston rod.
  • the piston rod is contained within a cylindrical button, which cylindrical button is configured to block the rearward motion of the piston rod until the piston is fully inserted into the syringe cartridge, after which, the syringe cartridge and piston are then allowed to retract, hiding the needle.
  • W003097133 discloses an injection device with automatically retractable needle configured to use cartridges.
  • the disclosed device includes a spring loaded plunger mechanism and a spring loaded needle retraction mechanism.
  • the plunger mechanism is first provided with a loaded spring, which spring is stronger than a spring provided in the needle retraction mechanism. Upon release, said plunger spring compresses the retraction mechanism spring, exposing the needle, injecting the medicinal product contained in a cartridge, after which, the plunger mechanism is disengaged.
  • the cartridge is then allowed to retract by action of the retraction mechanism spring, which spring is located around the body of the cartridge and acting upon a radial extension at the proximal end of said cartridge.
  • the devices described therein require the use of modified capsules in order to work effectively. Furthermore, due to their complexity, the disclosed devices are not easily loadable with a cartridge and are therefore more suitable to be provided as an assembled device rather than a kit.
  • W02001024852 discloses a retractable dental syringe, which syringe includes a hollow body configured to accept a cartridge, a push ring and a spring loaded spring assembly configured to enter the body of said cartridge.
  • a piston rod pushes a piston contained within the cartridge, thereby pushing the fluid contents of the cartridge through the needle. Further pressure exerted by the piston rod displaces the needle from the push ring, pushing the seal of the cartridge inwards and letting the needle retract into the body of the cartridge by action of spring pressure.
  • the device disclosed in W02001024852 still requires the use of capsules having non-standard elements. Furthermore, once the needle is retracted through the opening at the distal end of the capsule, said opening is no longer sealed, thereby allowing any residual fluids still in the capsule to leak.
  • US20150065955A1 discloses a syringe for injecting medicament having automatic needle extension and retraction the syringe includes a first body with a cylindrical cross-section, which includes a front end and a rear end. The front end is provided with a means of transport smaller in diameter than the first body, which is fastened to same with a first fastening protrusion.
  • the means of transport include a male frustoconical element which in turn includes conduits to transport said medicament, the front end further including a sealing protrusion and, located above said first fastening protrusion and said first sealing protrusion, a first alignment protrusion, inside said first body there is also a first elastic element which is fastened to said rear end of said first body with a posterior spring clip, and to said means of transport with an anterior spring clip, the rear end of said first body includes a handle.
  • the syringe of US '955, similarly to WO '852 disadvantageously leaves the distal end of the syringe open upon retraction of the needle, thereby allowing any residual fluids still in the capsule to leak.
  • US5324265A1 discloses a syringe having a retractable needle and a retraction mechanism inside a hollow plunger, the distal end of which retraction mechanism has coupling features complementary to coupling features on the proximal end of the retractable needle.
  • the retraction mechanism and the needle are configured to engage when the hollow plunger nears its end of travel inside the syringe barrel. Further displacement of said plunger in a distal direction causes the retraction mechanism to travel towards the proximal end of the syringe under action of a retraction spring. In this last displacement, the retraction mechanism pulls the retractable spring which moves in solidarity with the distal end of the retraction mechanism, and in this way becoming completely encased by the hollow plunger.
  • the distal end of the syringe is disadvantageously left open, leading to possible leakage of leftover medicinal fluid and/or blood backflow.
  • US9233209B2 discloses an injection device for injecting a medicament from a cartridge through a needle cannula.
  • the injection device includes an actuator for driving a piston driver and includes an end of stroke limiter. When the piston driver is arrested by the end of stroke limiter a shielding driver is automatically triggered to actively shift the needle cannula into a shielded state.
  • the injection device may also include a fluid dispensing interruption mechanism that automatically interrupts fluid flow when the piston driver has moved a predetermined stroke length.
  • the injection device may also include a single pre-stressed spring acting exclusively in a linear compression mode or exclusively in a torsion mode and adapted to sequentially drive the device to enable fully automatic operation.
  • US20180353709A1 discloses a medicament injection device comprising: a main body configured to receive a medicament cartridge, a needle sleeve axially movable with respect to the main body, a needle holder holding a needle, and a displacement element coupled to the needle holder and disengageably coupled to the needle sleeve; wherein, upon axial displacement of the needle sleeve by a predefined distance in a proximal direction, the needle carrier and needle are displaced axially in a proximal direction.
  • the device, and more in particular, the coupling of the needle to the medicament cartridge requires the user or a spring to overcome the resistance offered by the engagement elements of the needle holder, thereby creating a snapping effect when engagement between the needle holder and the cartridge is attained.
  • the cartridge is disadvantageously subject to sudden deceleration after engaging with the proximal end of the needle. This sudden deceleration, besides being potentially damaging to one or more elements of the syringe, may result in undesired loss of medicinal fluid.
  • a device suitable for the use of said capsules and which device comprises smooth engagement of the cartridge with the needle as well as self-retraction of the needle into the body of the device by manipulation of a sliding element.
  • the present invention and embodiments thereof serve to provide a solution to one or more of above-mentioned disadvantages.
  • the present invention relates to a syringe-cartridge assembly according to claim 1, having the advantage that the syringe is intuitively operable for a healthcare worker, or any other individual.
  • the syringe can be operated like a regular cartridge using syringe, wherein the retraction mechanism is allowed to be engaged in one fluid motion which does not differ from normal operation of a regular syringe. Consequently, the syringe according to the present invention does not leave the operator in doubt about whether or not retraction has been correctly and/or completely engaged, nor does the operator have the possibility to re-use the syringe. Furthermore, the present syringe being configured to use cartridges, the volumetric accuracy of injection is optimally preserved.
  • Figure 1 illustrates a syringe with a straight walled outer plunger before cartridge activation.
  • Figure 2 illustrates a syringe with a straight walled outer plunger with an activated cartridge.
  • Figure 3 illustrates a syringe with an outer plunger having a threaded interface before cartridge activation.
  • Figure 4 illustrates a syringe with an outer plunger having a threaded interface and with an activated cartridge.
  • Figure 5 illustrates the syringe after all the medicinal fluid has been pushed out of the cartridge.
  • Figure 6 illustrates the syringe after all the medicinal fluid has been pushed out of the cartridge and said cartridge has been retracted together with the needle.
  • Figure 7 illustrates another embodiment of the invention wherein a proximal plunger cap is comprised of two parts that can be separated from each other.
  • the present invention relates to a syringe - cartridge assembly.
  • a compartment refers to one or more than one compartment.
  • the terms "one or more” or “at least one”, such as one or more or at least one member(s) of a group of members, is clear per se, by means of further exemplification, the term encompasses inter alia a reference to any one of said members, or to any two or more of said members, such as, e.g., any >3, >4, >5, >6 or >7 etc. of said members, and up to all said members.
  • a first aspect of the invention relates to a syringe having a needle retraction mechanism and designed to receive a cartridge having a medicinal product
  • said syringe comprises: a. a barrel comprising a hollow body and a hollow nose end, said barrel is able to retrieve a cartridge in said hollow body, preferably through an open proximal end of the barrel; b. a needle holder positioned in said nose end, wherein said needle holder comprises an internal cavity configured to receive the distal end of a cartridge, and into which the proximal end of the needle extends, by preference, the needle holder comprises a needle, more preferably, the needle holder is provided with hooking means configured to connect to a cartridge shoulder; c.
  • a plunger insertable in said barrel, preferably though an open distal end of the barrel; said plunger includes a retraction mechanism comprising a hollow inner plunger within a hollow outer plunger, wherein said inner plunger comprises a retraction spring, said spring is connecting a proximal plunger cap attached to a proximal end of said outer plunger and an distal plunger cap attached to the distal end of said inner plunger, said spring being positioned along the axis of both the outer plunger and inner plunger.
  • the term “syringe” relates to a simple reciprocating pump consisting of a “plunger” or “piston” that fits tightly within a cylindrical tube.
  • the plunger can be linearly pulled and pushed along the inside of said cylindrical tube, allowing the syringe to take in and expel liquid through a discharge orifice located at distal end of the syringe.
  • the nose end is fitted with a needle holder, which needle holder comprises a needle, e.g. a hypodermic needle.
  • Syringes as described herein are frequently used in clinical medicine to administer injections, or to infuse intravenous therapy into the bloodstream.
  • retraction mechanism indicates any mechanism which allows the automatic retraction of the needle holder including the needle inside the syringe, in order to prevent re-use of the syringe and/or to lower the risk of needle-stick injury.
  • the distal plunger cap relates to a specific element of the retraction mechanism which extracts the needle and pulls it inside the syringe.
  • actual retraction is achieved by means of a "retraction spring”, indicating that the spring is under tension during operation of the syringe, and retracts to its resting state upon engagement of the retraction mechanism, thereby retracting the inner plunger, distal plunger cap, cartridge and the needle holder coupled thereto.
  • the distal plunger cap can be comprised of one single part or of one or more separate parts that together form a functional plunger cap.
  • the needle holder may comprise a needle only on its proximal end in order to engage the distal end of a cartridge, the distal end of which needle holder being a luer cone configured to receive a standard hypodermic needle.
  • the syringe is made more versatile because the choice of the needle is done just before the injection instead of during the syringe procurement process.
  • said proximal plunger cap relates to a specific element of the retraction mechanism which covers the proximal end of the plunger and provides at least two substantially cylindrical sections, preferably three cylindrical sections. At least one such cylindrical section is configured to provide support upon which the proximal end of said retraction spring can be attached. Similar to the distal plunger cap, said proximal plunger cap may be provided as a single part or in two or more parts that together form a proximal plunger cap.
  • a plunger cap cylinder configured to support the return spring is further provided separate from a rear cover, which plunger cap cylinder is equipped with a plurality of radially extending hooking means, said hooking means being configured to engage the proximal end of the outer plunger.
  • said hooking means are bendable hooking means.
  • the plunger cap cylinder is provided with three or more bendable hooking means.
  • said bendable hooking means are configured to bend between -40° and 5° relative to the axis of the plunger cap cylinder.
  • a two or more part proximal plunger cap permits, very advantageously, to assemble the retraction spring onto the plunger cap cylinder and distal plunger cap before pre-tensioning the spring. In this way, assembling of the plunger is greatly facilitated.
  • hooking means relates to any means which reversable interconnect two or more elements to each other.
  • Specific hooking means comprise complementary protrusions and/or indentations, areas of higher friction or adhesion etc.
  • the proximal end of said inner plunger is defined by a plurality of bendable flanges, said plurality of bendable flanges comprises at least two bendable flanges, preferably at least three bendable flanges.
  • bendable flanges herein relates to any bendable parts extending from the plunger in the direction of the needle holder, wherein their bendable nature is the result of e.g. provision of a deformable material, provision of a certain thinness to the flanges etc.
  • the syringe according to the present invention comprises a vastly improved needle retraction mechanism, having the advantage that the syringe is intuitively operable for a healthcare worker, or any other individual.
  • the invention can be operated like a regular syringe, wherein the retraction mechanism is automatically engaged as soon as the syringe has been emptied.
  • Self-locking syringes known in the art commonly require the operator to perform multiple and/or additional steps in order to engage the mechanism, i.e. the plunger has to be pushed further forward although the syringe has already been emptied, the coupling of the needle holder to the distal plunger cap and the decoupling of the distal plunger cap from the plunger taking place in separate movements etc.
  • the present invention comprising bendable flanges on the plunger however allows the retraction mechanism to be engaged in one fluid motion which does not differ from normal operation of a regular syringe. Consequently, the syringe according to the present invention does not leave the operator in doubt about whether or not retraction has been correctly and/or completely engaged, nor does the operator have the possibility to re-use the syringe. As a result, any risk of needle-stick injuries has been eliminated and re-use has been effectively prevented. Furthermore, as the syringe is configured to use cartridges, the volumetric accuracy of injection is optimally preserved.
  • the inner plunger has, relative to the outer plunger, an advanced position A and a retracted position B, in which position said inner plunger is fully retracted into said outer plunger.
  • This retracted position B avoids, advantageously, the return of the inner plunger to the extended position A. In this way, reuse of the syringe is advantageously avoided.
  • the plurality of bendable flanges are bendable over an angle of between 5° and 45°, more preferably between 5 and 40° relative to the axial centerline of the syringe.
  • This bending range of the bendable flanges permits, advantageously, for said bendable flanges to provide sufficient tension for the inner plunger to remain in the advanced position A.
  • the bending range of the bendable flanges is such that it permits said bendable flanges to easily bend under side pressure. Said pressure being directed towards the axis of the of the inner plunger as the bendable flanges contact the opening at the proximal end of the cartridge. This permits the unseating of said bendable flanges from the annular abutment, allowing the inner plunger to retract into the outer plunger.
  • the outer plunger is a hollow cylinder comprising an inner annular abutment upon which the bendable flanges rest as the inner plunger is in the advanced position A.
  • Said annular abutment provides a resting surface which advantageously permits a safe and reliable transmission of the force applied to the plunger to the inner plunger without the risk that said inner plunger slips under said tension.
  • the needle holder is provided with hooking means configured to connect to a cartridge shoulder.
  • the hooking means of the needle holder are a plurality of bendable grippers. More preferably, said plurality of bendable grippers are at least two, preferably at least three bendable grippers.
  • the presence of a plurality of hooking means allow for a firmer grip around the shoulder of the cartridge. This permits, very advantageously, the extraction of the needle holder along with the cartridge without the need for further extraction means other than those already included in the plunger. Additionally to safety, two other characteristics that are essential to any medical material are functional reliability and ease of manufacture.
  • bendable flanges with which the proximal end of the inner plunger is equipped. These flanges advantageously reduce the number of moving parts necessary for the effective operation of the syringe, while making the inner plunger easier to manufacture and assemble.
  • the plurality of bendable grippers are bendable over an angle of between 30° and -30° relative to the axial centerline of the syringe. This bending range, advantageously permits the hooking means to override the distal end of the cartridge and engage the shoulder of said cartridge.
  • a common issue with syringes configured to use cartridges relates to the initial activation of the syringe where the user has to press a plunger, building up pressure until the cartridge sear is punctured by a proximal extensions of the needle. During this step, significant pressure upon the plunger is often required, which pressure is often suddenly released after the puncture of the cartridge seal, resulting in spilling of some of the drug contained in the syringe.
  • the outer surface of the outer plunger has a thread, which thread is complimentary to a second thread on the inner surface of the barrel. The threads present in both the outer plunger and barrel permit a safer handling of the syringe as the threads permit a better control of the advance of the plunger into the barrel.
  • said threads permit, advantageously, a reduction of the force the user needs to exert in order to press the cartridge against the needle holder and to override the hooking means of said needle holder.
  • Another aspect of the invention relates to an assembly, comprising a syringe and a cartridge having a medicinal product, said cartridge is contained in the barrel of the syringe, and between the needle holder and the plunger.
  • the inner plunger is able to extend into the cartridge through its proximal end, the distal plunger cap on the distal end of said inner plunger being configured to rest against the rear seal inside said cartridge.
  • the cartridge comprises a hollow body sealed on both ends by a rear seal near its proximal end and a front seal on its distal end, which distal end is further provided with a shoulder and which cartridge is configured to air-tightly contain an amount of fluid within its hollow body, between said rear seal and said front seal.
  • a rear seal near its proximal end
  • a front seal on its distal end
  • cartridge is configured to air-tightly contain an amount of fluid within its hollow body, between said rear seal and said front seal.
  • the distal cap can present a protrusion to connect with the plunger stopper. This allows, advantageously, for an operator to be able to perform a negative pressure at the beginning of the injection (Lesser maneuver).
  • the present invention is also reached by a plurality of methods of delivering a medicinal product to a subject by means of a syringe.
  • a first said method comprising the steps of: a. introducing a cartridge into a barrel of a syringe comprising a needle holder, by preference, the cartridge is inserted via the proximal end of the outer barrel; b. introducing the distal end of the plunger into the barrel, by preference, the plunger is inserted into the barrel through the proximal end of the outer and into the proximal end of the barrel; c.
  • Yet another method of delivering a medicinal product to a subject by means of a syringe comprises the steps of: a. introducing a cartridge into a barrel of a syringe comprising a needle holder, by preference, the cartridge is inserted via the proximal end of the outer barrel; b. introducing the distal end of the plunger into the barrel, by preference, the plunger is inserted into the barrel through the proximal end of the outer and into the proximal end of the barrel; and c. engaging the needle holder onto a cartridge, preferably by engaging an outer plunger thread with a barrel thread, then turning plunger until the bendable grippers snap around the cartridge shoulder.
  • the needle holder is engaged onto the cartridge by pressing onto the plunger until the bendable grippers snap around the cartridge shoulder. In this way, the cartridge seals remain intact until the time of use.
  • the needle holder is engaged onto the cartridge by engaging an outer plunger thread with a barrel thread, then turning plunger until the bendable grippers snap around the cartridge shoulder.
  • the above mentioned method permits, advantageously, a more controlled rupture of the front seal of the cartridge and to avoid excessive advance of the plunger, thereby avoiding the spillage of any medicinal fluid.
  • fluid communication between the inside of the cartridge and the open distal end of the needle is established, making the syringe quickly and easily ready for administering the contents of the cartridge.
  • the present invention is suitable to be made available in a kit comprising a plurality of syringes, said kit further including a plurality of cartridges.
  • the present invention can also be made available in another kit, wherein each syringe is provided in two parts, a plunger and a barrel equipped with a needle holder.
  • FIGS 1 to 6 illustrates a syringe (1) according to an embodiment of the current invention.
  • Said syringe comprises a straight walled outer plunger before cartridge activation.
  • a needle holder (4) is presented against the inner surface of the hollow nose of the barrel (2).
  • a cartridge (5) is shown within the same barrel (2), the distal end of each cartridge is resting against the proximal end of the bendable grips (16) of the needle holder (4).
  • a plunger (18) is shown inserted into the barrel (2), said plunger being comprised of hollow outer plunger (3) and inner plunger (8).
  • the inner plunger (8) is shown in its advanced position which position it holds by having its bendable flanges (13) expanded and resting against the annular abutment inside the outer plunger (3).
  • the position of the inner plunger (8) relative to the outer plunger (3) holds the retraction spring (7) under tension.
  • the proximal end of said spring is here shown attached to a proximal plunger cap (6) at the proximal end of the outer plunger (3).
  • the distal end of the retraction spring (7) is here shown attached to the distal plunger cap (9), which distal plunger cap (9) and part of the inner plunger (8) are shown extending into the cartridge (5) and pressing upon the rear seal (10).
  • Figure 2 illustrates a syringe with a straight walled outer plunger with an activated cartridge.
  • the plunger (18) is shown inserted further into the barrel (2), having acted upon cartridge (5) by intermediate of the distal plunger cap (9) upon the rear seal (10).
  • Said cartridge is shown pressed against the needle holder (4) and having a piercing the front seal (11).
  • Said cartridge (5) is shown engaged to the needle holder (4) by means of the bendable grippers (16) which are now shown engaging the cartridge shoulder (17).
  • FIG 3 illustrates the syringe (1) with an outer plunger (3) having a threaded interface before cartridge activation.
  • a needle holder (4) is presented against the inner surface of the hollow nose of the barrel (2).
  • a cartridge (5) is shown within the same barrel (2), the distal end of each cartridge is resting against the proximal end of the bendable grips (16) of the needle holder (4).
  • a plunger (18) is shown partially inserted into the barrel (2). Said plunger being comprised of a hollow outer plunger (3) and an inner plunger (8). In this figure, both the barrel and outer plunger are shown engaged by the barrel threads (15) and the outer plunger threads (14).
  • the inner plunger (8) is shown in its advanced position which position it holds by having its bendable flanges (13) expanded and resting against the annular abutment inside the outer plunger (3).
  • the position of the inner plunger (8) relative to the outer plunger (3) holds the retraction spring (7) under tension.
  • the proximal end of said spring is here shown attached to a proximal plunger cap (6) at the proximal end of the outer plunger (3).
  • the distal end of the retraction spring (7) is here shown attached to the distal plunger cap (9), which distal plunger cap (9) and part of the inner plunger (8) are shown extending into the cartridge (5) and pressing upon the rear seal (10).
  • Figure 4 illustrates a syringe with an outer plunger having a threaded interface and with an activated cartridge.
  • the plunger (18) is shown positioned farther into the barrel (2) by action of the outer plunger threads (14) and the barrel threads (15).
  • Cartridge (5) is shown pressed against the needle holder (4) and having a pierced the front seal (11). Said cartridge (5) is shown engaged to the needle holder (4) by means of the bendable grippers (16) which are now shown engaging the cartridge shoulder (17).
  • Figure 5 illustrates the syringe (1) after all the medicinal fluid has been pushed out of the cartridge (5) by action of the plunger (18) upon the rear seal (10) of the cartridge (5).
  • the inner plunger (8) is here shown in its froward position and with its bendable flanges (12) in contact with the proximal end of the cartridge (5) immediately before retraction of said inner plunger (8), cartridge (5) and needle holder (4).
  • Figure 6 illustrates the syringe (1) after all the medicinal fluid has been pushed out of the cartridge (5) and said cartridge has been retracted together with the needle.
  • the cartridge (5) is shown fully retracted into the plunger (18).
  • the inner plunger (8) is here shown with its bendable flanges (12) resting against the proximal plunger cap (6).
  • the full length of needle is shown completely shrouded by the hollow nose of the barrel (2), thereby rendering the whole device safe.
  • Figure 7 illustrates another embodiment of the invention wherein a proximal plunger cap is comprised of two parts that can be separated from each other, one part being a plunger cap cylinder (19) and the other being a cover (21).
  • the proximal end of the retraction spring (7) is shown with a plurality of its coils wrapped around said proximal plunger cap cylinder (19), thereby forming a rigid attachment between retraction spring (7) and the plunger cap cylinder (19).
  • Said plunger cap cylinder (19) is here provided with a plurality of bendable hooks (20) extending from its proximal end.
  • Said bendable hooks (20) are shown engaged to a hole in the center of the proximal end of the outer plunger (3).
  • a cover (21) is shown here placed onto the proximal end of the outer plunger (3), said cover (21) covering the tips of said bendable hooks (20).

Landscapes

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

Abstract

La présente invention concenre une seringue ayant un mécanisme de rétraction d'aiguille et conçue pour recevoir une cartouche ayant un produit médicinal, ladite seringue comprenant : un cylindre conçu pour recevoir une cartouche, un porte-aiguille apte à venir en prise avec ladite cartouche et un plongeur, ledit plongeur comprenant un mécanisme de rétraction comprenant un plongeur interne creux à l'intérieur d'un plongeur externe creux, ledit plongeur interne comprenant un ressort de rétraction, ledit ressort reliant un capuchon de plongeur proximal fixé à une extrémité proximale dudit plongeur externe et un capuchon de plongeur distal fixé à l'extrémité distale dudit plongeur interne, ledit ressort étant positionné le long de l'axe du plongeur externe et du plongeur interne.
PCT/EP2022/072090 2021-08-06 2022-08-05 Ensemble seringue-cartouche WO2023012335A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP21190126.9 2021-08-06
EP21190126 2021-08-06

Publications (1)

Publication Number Publication Date
WO2023012335A1 true WO2023012335A1 (fr) 2023-02-09

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WO (1) WO2023012335A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5324265A (en) 1993-10-20 1994-06-28 Gabbard Murray Gabbard Inc. Hypodermic safety syringe with retracting needle system
WO2001024852A1 (fr) 1999-10-01 2001-04-12 Retractable Technologies, Inc. Seringue dentaire retractable
WO2001072362A1 (fr) 2000-03-24 2001-10-04 David William Parker Seringue hypodermique
WO2003097133A1 (fr) 2002-05-17 2003-11-27 Owen Mumford Limited Dispositif d'injection avec aiguille a retraction automatique
US20150065955A1 (en) 2013-08-27 2015-03-05 Daniel Alberto Ierfino Syringe for the injection of a medicament with automatic needle extension and retraction
US9233209B2 (en) 2010-08-27 2016-01-12 Novo Nordisk A/S Medical injection device
US20180353709A1 (en) 2015-11-27 2018-12-13 Sanofi-Aventis Deutschland Gmbh Medicament injection device

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5324265A (en) 1993-10-20 1994-06-28 Gabbard Murray Gabbard Inc. Hypodermic safety syringe with retracting needle system
WO2001024852A1 (fr) 1999-10-01 2001-04-12 Retractable Technologies, Inc. Seringue dentaire retractable
WO2001072362A1 (fr) 2000-03-24 2001-10-04 David William Parker Seringue hypodermique
WO2003097133A1 (fr) 2002-05-17 2003-11-27 Owen Mumford Limited Dispositif d'injection avec aiguille a retraction automatique
US9233209B2 (en) 2010-08-27 2016-01-12 Novo Nordisk A/S Medical injection device
US20150065955A1 (en) 2013-08-27 2015-03-05 Daniel Alberto Ierfino Syringe for the injection of a medicament with automatic needle extension and retraction
US20180353709A1 (en) 2015-11-27 2018-12-13 Sanofi-Aventis Deutschland Gmbh Medicament injection device

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