WO2022079576A1 - Sous-ensemble de gaine passive d'extrémité de non-injection d'aiguille et ensemble aiguille de type stylo de sécurité - Google Patents

Sous-ensemble de gaine passive d'extrémité de non-injection d'aiguille et ensemble aiguille de type stylo de sécurité Download PDF

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Publication number
WO2022079576A1
WO2022079576A1 PCT/IB2021/059311 IB2021059311W WO2022079576A1 WO 2022079576 A1 WO2022079576 A1 WO 2022079576A1 IB 2021059311 W IB2021059311 W IB 2021059311W WO 2022079576 A1 WO2022079576 A1 WO 2022079576A1
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WO
WIPO (PCT)
Prior art keywords
needle
assembly
protective sleeve
injection
guiding ring
Prior art date
Application number
PCT/IB2021/059311
Other languages
English (en)
Inventor
Marcin ROZWADOWSKI
Weng Kian YONG
Original Assignee
Pentamaster Mediq Sdn. Bhd.
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 Pentamaster Mediq Sdn. Bhd. filed Critical Pentamaster Mediq Sdn. Bhd.
Publication of WO2022079576A1 publication Critical patent/WO2022079576A1/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
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • A61M5/1626—Needle protectors therefor
    • 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
    • A61M5/3293—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
    • A61M5/345—Adaptors positioned between needle hub and syringe nozzle
    • 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
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase

Definitions

  • the present invention relates to a passive sheath sub-assembly of a needle non-injection end, for a disposable sterile needle assembly designed to cooperate with a pen injector and a contained therein primary packaging filled up with an aseptic medicinal product, together constituting a needle-based injection system for medical use.
  • the present invention relates also to a disposable sterile needle assembly provided with the passive sheath sub-assembly of the needle non-injection end according to the invention, as well as to a needle-based injection system for medical use provided with the disposable sterile needle assembly according to the invention.
  • the present invention relates also to a guiding ring and a protective sleeve for the passive sheath sub-assembly of the needle non-injection end according to the invention.
  • the present invention relates to a unit package with the aseptically sealed disposable sterile needle assembly according to the invention and a user packaging comprising a set of the unit packages according to the invention and, preferably the pen injector.
  • the needle-based injection systems for medical use are becoming more commonplace in use because they may be easily and unaided used by an individual patient.
  • the medicinal product which is aseptically sealed in a primary packaging disposed in the pen injector and which is prepared for administration into a patient’s body by the use of the needle-based injection system, may be an anti-histamine drug, human growth hormone, an osteoporosis medication, an anti-thrombotic medication, a botulin toxin, a medication against chronic migraine, an analgesic medication or insulin.
  • the pen injector (also referred to as hearinga pen” or seekinga penfill”) is an injection device of singleuse or multiple-use, which contains a non-replaceable or replaceable primary packaging with a dosed and sterilized medicinal product and which is intended for use in conjunction with a disposable sterile needle.
  • the primary packaging is also named as hearinga cartridge” or a sealed ..ampoule” or strongesta vial”.
  • the primary packaging has a barrier (also named as hearinga septum” or termeda cartridge septum”), which usually is in the form of a rubber membrane or a hole plug and which tightly closes the sterilized medicinal product contained inside of this packaging.
  • the primary packaging may be a single-dose or multi-dose container, either a single-chamber or multi-chamber container, also referred to as a single-compartment or a multi-compartment container.
  • the pen injector together with the contained therein primary packaging with the medicinal product is closed with a protective cap.
  • the disposable sterile needle also often referred to as conventionala pen needle” or frequentlya safety pen needle” orpatian injection pen needle”, is designed for cooperation with the pen injector and the contained therein primary packaging and is in the form of the needle assembly.
  • the needle assembly typically comprises a needle tube, a needle hub with attachment means for attachment of the needle assembly to the pen injector, protective component parts in the form of a needle container and a needle shield, as well as a seal.
  • the needle assembly is double-ended with an injection end from the patient’s side, which is designed for insertion into the patient’s body, and with a non-injection end from the side of the pen injector, which is designed for puncturing the barrier of the primary packaging and for receiving the medicinal product contained in this packaging.
  • the seal is a removable tight barrier that is designed to assure the sterility of the needle.
  • a needle point of the injection end has to be configured so that a pain experienced during insertion of this needle end into the patient’s body was minimized.
  • a needle point of the non-injection end has to be configured so that, firstly, to minimize negative effects of core screwing, also referred to as core drilling or coring, of this needle point into material of the barrier wall of the primary packaging, and, secondly, to minimize fragmentation of the material of the barrier wall of the primary packaging when the needle non-injection end point penetrates the barrier wall of the primary packaging.
  • the needle tube shall be lubricated at both the injection end from the patient’s side and the non-injection end from the side of the pen injector.
  • the lubricant shall not be visible as droplets of fluid on the outside surface of the needle tube, neither under normal vision nor corrected-to-normal or supported or aided vision.
  • the aseptically sealed needle assembly constitutes a unit package or a unit packaging that maintains the sterility of the needle.
  • the needle assembly in its unit package shall be subjected to a validated sterilization process that is the process acknowledged as being in conformity with the requirements. According to the requirements binding for this type of the devices intended for medical use, mounting the needle assembly onto the pen injector shall be possible without taking the needle assembly outside its open unit package, upon earlier removal of the seal. Neither materials applied in the needle assembly and the unit package nor structure of the needle assembly and the unit package may exert any effects harmful for the content of the unit package.
  • the materials and the structure of the needle assembly and the unit package shall assure preservation of the sterility of the needle assembly in the course of its normal operation, transportation and warehousing. Moreover, the structures of the needle assembly and the unit package shall exclude any possibility of their again tight closure by the seal upon when the unit package was opened for the first time so that the unit package once opened be the proof that the needle assembly disposed therein lost its sterility.
  • the unit package with the sterile needle is usually provided for the use to the patient or the medical personnel in the form of a user packaging comprising a collection of the unit packages, each with the needle assembly of the same type and from the same manufacturing batch.
  • Accidental needle stick injuries from contaminated medical needles expose patients and healthcare workers, especially nurses, to the serious risk of infection from blood-borne pathogens, including the viruses that cause hepatitis B and C, and HIV strictHIV, Human Immunodeficiency Virus”).
  • Accidental needle stick injuries from contaminated medical needles primarily occur during detachment of the sterile medical needle assembly from the pen injector after administering an injection to the patient and its throwing into a special container for medical wastes.
  • the needle assembly was supplied in the form of the unit package with the needle ends protected by means of the outer protective component parts, that is the needle container and the needle shield, which enable reshielding of the needle after its use, it is especially during the re-shielding of the needle assembly upon its detachment from the pen injector where accidental needle stick injuries occur.
  • the shield and the needle tube are of a construction and a material composition such that the sliding frictional force between the external surface of the shield and the patient body’s tissue exceeds the sliding frictional force between the internal surface of the shield and the external surface of the needle tube, and preferably also the force required to engage a locking mechanism into a state of holding the shield in a position shielding the needle end point, wherein the exceeding sliding frictional force has a value sufficiently high so that when the needle is extracted from the body the shield is retained by the patient’s tissue until after the complete extraction of the needle end point from the tissue, and preferably also until the locking mechanism has been engaged automatically or manually.
  • the end point Upon extraction of both the needle end point and the shield from the patient’s body, the end point is automatically disposed within the shield, and preferably the shield is locked in the position shielding the needle end point.
  • the shield should be made of a material of parameters such that a force value of sliding friction between its external surface and the body tissue is sufficiently high and exceeds a force value of sliding friction between its internal surface and the external surface of the needle tube made of surgical stainless steel.
  • the shield should be made of relatively hard and rigid material such that it is resistant to axial compressive and bending forces as well as to deformations in order to prevent the needle end point from penetration through the wall of the shield if it is unfavourably deformed under an external pressure when the shield together with the needle end point hidden therein are being withdrawn from the patient’s body.
  • the shield has to be made of plastic material having modulus of elasticity and strength of appropriate values and properly selected along with an external diameter of the shield in the needle assembly of a specific size.
  • the external diameter of the shield shall be small so that intervention of the surgical needle provided with the passive shield sub-assembly for the needle end point into the tissue and the pain correlated with this intervention as experienced by the patient are still as small as possible.
  • the internal diameter of the shield and the external diameter of the needle tube have to be selected so that to form a gap providing a relatively loose fit and in consequence static and sliding frictional forces between the shield and the needle of values lower than between the shield and the body tissue.
  • the external surface of the needle tube and/or the internal surface of the shield may be treated with a liquid or solid lubricating agent.
  • the external surface of the shield cannot be treated with any lubricating agent as it could cause the shield not being retained by the skin when the needle is withdrawn from the tissue. Lack of lubrication of the external surface of the shield renders injections being performed by means of this needle assembly provided with the described passive shield sub-assembly of the needle injection end very painful, in comparison with injections being performed by means of a disposable needle assembly that complies with the requirements of ISO 11608-2 Standard. In this aspect there is an issue of compliance with the requirements of covering of both needle ends, that is the needle injection end and the needle non-injection end, with a lubricating agent to decrease the pain of insertion.
  • the distal end of the shield that is the end which is inserted along with the needle end point into the patient’s body has to be sufficiently blunt so that it as such does not itself penetrate or pierce the tissues, that is additionally to and separately from the needle end point, because such situation would cause a substantial increase of the pain experienced by the patient when the needle provided with this passive shield sub-assembly of the needle end point is inserted into the body.
  • this distal end of the shield is conically shaped with the inclined distal end surface along circumference around the needle injection end so that easy entry of the needle injection end together with the distal end of the shield into the body is ensured, and so that further decrease of the pain experienced by the patient is ensured as well.
  • the circumferentially tapered distal end of the shield is being produced at the further stage of the heat forming of the plastic material into the shield.
  • the shield material has to be properly selected as sufficiently soft and flexible so that it is prone to easy heat forming.
  • Another difficulty here is the fact that during heat forming of the shield and its distal end with the distal end surface as being circumferentially tapered around the needle injection end, the shield material may adhere to the steel needle, which will result in malfunction of this passive shield sub-assembly of the needle end point and in the lack of shielding the needle end point after its extraction from the body.
  • Another aspect of the passive shield sub-assembly of the needle injection end relates to the standard practice of the medical personnel, which is applied when performing hypodermic injections, in other words the injections poserto the tissues”, that is not deep injections, as a rule into a skin fold, as an example the injections of insulin or botulinum toxin A, and when performing intramuscular injections that is deep injections.
  • hypodermic injections in other words the injections adjunct to the tissues
  • the injections that is not deep injections, as a rule into a skin fold, as an example the injections of insulin or botulinum toxin A, and when performing intramuscular injections that is deep injections.
  • personnel often check whether a vein or an artery was pierced. The check-up consists in small retraction of a syringe plunger and observation whether blood was drawn in. If it happens then the personnel slightly withdraw the needle from the tissue, not extracting it from the patient’s body and repeat insertion at a lightly modified angle.
  • WO 2016/196518 A1 discloses a disposable sterile needle assembly provided with a member for removable coupling with a body of a pen injector.
  • several types of needle assemblies with a concealed or a shortened needle non-injection end that is such which does not project outside a recess formed in a needle body in its proximal end, that is from the side of the pen injector.
  • the concealed or the shortened needle non-injection end is not intended to pierce a septum of a primary packaging comprising a sterile medicinal product.
  • This needle assembly requires use of a reusable interface member for removable coupling with the pen injector, which interface member is made of plastic material.
  • the reusable interface member functions as an intermediary member between the needle assembly and the pen injector, and is adapted to pierce the septum of the primary packaging and thereby enable flow of the medicinal product in the distal direction towards the needle assembly, that is towards the injection end.
  • Patent documents EP 2 839 854 B1 and US 2011/0257603 raise a need to shield both needle ends that is the needle injection end and the needle non-injection end after accomplishment of an injection.
  • a disposable sterile needle assembly is disclosed, which is equipped with a sub-assembly of double passive shields for the injection end and the non-injection end, which sub-assembly automatically shields the injection and the non-injection ends when the injection is accomplished and the needle assembly is removed from a pen injector.
  • the needle non-injection end shield is hold in its initial position, in which the non-injection end is uncovered, and is disengaged from this position under force of an expanding spring when the needle assembly after accomplishment of the injection is removed from a pen injector body, until the shield reaches its after-use position, in which the non-injection end is covered.
  • activation of the needle non-injection end shield is in kinematic connection with the injection end shield and is possible only when activation of the injection end shield is performed, which takes place after the injection is accomplished.
  • a disposable sterile needle assembly which is provided with a passive sheath sub-assembly for a needle non-injection end, in which passive sheath sub-assembly a member sheathing the needle non-injection end is mounted by means of a screwed connection in a recess formed in a needle hub for receiving a pen injector. Thread of the member sheathing the needle non-injection end is identical with a thread of the pen injector.
  • the sheathing member is provided with coupling means for its fast connection with the pen injector.
  • the pen injector After screwing the pen injector into the recess of the needle hub, it should enter into a fixed connection with the sheathing member so that when the pen injector is unscrewed after an injection is accomplished the sheathing member rotates together with the pen injector and moves in the proximal direction until the position in which complete sheathing of the non-injection end is achieved.
  • the non-injection end pierces a septum of a primary packaging, which septum tightly closes an aseptic medicinal product contained inside the primary packaging, which will enable to perform the injection, however, without sheathing the needle non-injection end after accomplishment of the injection.
  • screwing the pen injector into the recess of the needle hub is not complete, that is the fixed connection between the pen injector and the sheathing member is not reached, then the needle non-injection end will become contaminated, but after unscrewing the needle assembly from the pen injector the sheathing of the contaminated needle non- injection end will not take place.
  • the objective of the present invention is to design a reliable passive sheath sub-assembly of a needle non-injection end for a disposable needle assembly intended for cooperation with a pen injector and a primary packaging comprised therein, together constituting a needle-based injection system for medical use, wherein construction and dimensions of the passive sheath sub-assembly of the needle non-injection end and the disposable needle assembly will guarantee undisturbed cooperation with the pen injector and concurrently will fulfil all requirements relating to medical devices of this type as defined in ISO 11608 Standard under the general title: “Needle-based injection systems for medical use — Requirements and test methods”, and specifically as defined in Part 2 of the Standard entitled: “Needles”, that is ISO 11608-2 Standard.
  • Another objective of the present invention is elaboration of the passive sheath subassembly of the needle non-injection end, which operation will be reliable and independent of practices or techniques for the needle insertion, which are applied by the medical personnel to perform hypodermic or intramuscular injections.
  • Yet another objective of the present invention is elaboration of the passive sheath subassembly of the needle non-injection end having a structure which will guarantee irreversible blocking the sheath in the position sheathing the needle non-injection end point.
  • Yet other objective of the present invention is to design the passive sheath sub-assembly of the needle non-injection end having the structure and materials used for component parts and structure elements, which will minimize or eliminate negative effects of coring or core drilling of the needle non-injection end and its sheath in a septum of a primary packaging, including undesirable torsion and compression of the sheath into a concertina, and fragmentation of a material of a barrier wall of the primary packaging.
  • the important objective of the invention is elaboration of a needle non-injection end passive sheath sub-assembly of a construction which enables substantially easier mounting of the needle assembly onto the pen injector due to reducing of sliding frictional force, between the needle non-injection end sheath and the barrier material of the primary packaging, arising during mounting the needle assembly onto the pen injector.
  • the construction of the needle sub-assembly according to the invention shall guarantee that the sheath is firmly hold by the barrier of the primary packaging when the needle assembly is being dismounted from the pen injector, due to obtaining the static frictional force, between the sheath and the barrier material of the primary packaging, of a sufficient value.
  • the construction of the sheath sub-assembly according to the present invention shall guarantee radical reduction of the sliding frictional force between the sheath and the needle tube.
  • Another important objective of the invention is to design a needle non-injection end passive sheath sub-assembly of a construction, which will provide a sheath having a relatively small outer diameter with relation to required and necessary inner and outer diameters of a needle tube and which will enable to cover an outer surface of the sheath with a lubricating agent, with the simultaneous guarantee of holding of the sheath by a barrier material of the pen injector, but also with the guarantee of free passage of the needle non-injection end in the distal direction relative to this sheath being hold during this phase, which will guarantee on one hand - easy mounting of the needle assembly onto the pen injector, and on the other hand - reliable automatic sheathing of the needle noninjection end along with its end point after dismounting of the needle from the pen injector.
  • the objective of the invention is also providing a sterile single-use needle assembly with a sheath sub-assembly for the needle non-injection end, which ensures sheathing the noninjection end as being performed automatically during removal of the needle assembly from the pen injector - always in the case when the injection was accomplished or also always in the case when the injection was not accomplished but the needle non-injection end point was in contact with a medicinal product comprised in a primary packaging disposed in the pen injector.
  • Further objective of the present invention is to provide a needle assembly having a passive sheath sub-assembly for the needle non-injection end, that is such sheath subassembly for the non-injection end that its operation for achieving efficient sheathing of the non-injection end does not require from the user any active and deliberate execution of any specific actions and such that its operation will become realized autonomously during removal of the needle assembly from the pen injector, that is independently of the user.
  • Yet further objective of the present invention is elaboration of a needle assembly with a needle non-injection end sheath sub-assembly comprising a small number of component parts and constructional elements, and for simplification of its handling by the user - all of them together being retained in a constructional coupling before, during and after the use of the needle assembly.
  • Yet another further objective of the invention is to design a needle assembly with a needle non-injection end sheath sub-assembly of a construction ensuring realization of the function of passive sheathing of this needle end, without a need of application - upon dismounting of the needle assembly from the pen injector - of any additional component parts for the needle non-injection end passive sheath sub-assembly, which component parts would be distinct from the ones already comprised in the needle assembly.
  • the objective of the invention is to design a disposable sterile needle assembly provided with such passive sheath sub-assembly for the needle non-injection end, which operation will be independent of operation of a needle injection end sub-assembly, and in consequence sheathing the needle non-injection end after removal of the needle assembly from the pen injector will be guaranteed, even in the case when because of different reasons an insertion into the patient’s body will not be accomplished.
  • Another objective of the invention is to elaborate a needle assembly with a passive sheath sub-assembly for the needle non-injection end, which in comparison with solutions of the needle assemblies known from the state of art will substantially minimise a risk of a needle stick injury and thereby contagion of the user.
  • Further objective of the invention is to provide a needle assembly of a simple structure comprising a small number of component parts and constructional elements and cheap in manufacturing.
  • the objective of the present invention is to provide a needle assembly guaranteeing automatic sheathing of the needle non-injection end after accomplishment of an injection, that is such that it will reliably sheathe the needle non-injection end independently of that whether during operating with this needle assembly and an injector pen cooperating therewith the user will execute any actions precisely or not.
  • the objective of the invention is to configure a needle assembly with a needle non- injection end passive sheath sub-assembly of a construction that ensures irreversible locking of the sheath in the position of sheathing the needle non-injection end after detachment of the needle assembly from a pen injector body once any contact of the non- injection end with a medicinal product contained in a primary packaging disposed in the pen injector takes place, that is in the case when even the smallest contact between the non-injection end and the medicinal product occurs, during introducing of the non-injection end into the inside of the primary packaging via the barrier that tightly closes the sterilized medicinal product in this packaging.
  • a disposable sterile needle assembly for cooperation with a pen injector including a primary packaging filled up with an aseptic medicinal product, for establishment of a needle-based injection system for medical use, comprises a needle hub having a recess configured for detachable connection with the pen injector, a needle tube fixedly mounted in the needle hub and having an injection end with a needle point for an insertion into a patient's body to administer an injection of the medicinal product and a non-injection end with a needle point for a puncture of a septum of the primary packaging to transfer the medicinal product to the patient's body, a passive sheath sub-assembly of the needle non-injection end, the passive sheath sub-assembly being mounted in the recess of the needle hub, the recess surrounding the non-injection end with the needle point, wherein the needle hub and the needle tube extend essentially around a longitudinal axis of the needle assembly, the longitudinal axis of the needle assembly is defined by a longitudinal axis
  • a needle non-injection end passive sheath sub-assembly wherein the fixing means for fixing the guiding ring in the needle hub immovably lengthwise the longitudinal axis constitute a hollow with an undercut made in the recess of the needle hub and the distal end of the guiding ring.
  • the passive sheath sub-assembly comprises engagement means configured for engagement of the protective sleeve in its initial position and arranged in the needle hub, the guiding ring and the protective sleeve, wherein the engagement means constitute, preferably, a bottom of the hollow in the recess of the needle hub, a respectively sized diameter of the through hole of the guiding ring at the distal end of the guiding ring and a respectively sized outer diameter of the distal end on the distal portion of the protective sleeve.
  • the passive sheath sub-assembly comprises distal limiting means configured for restriction of movement of the protective sleeve in the distal direction relative to the guiding ring and arranged in the needle hub and the protective sleeve, wherein the distal limiting means constitute, preferably, the bottom of the hollow in the recess of the needle hub and the distal end on the distal portion of the protective sleeve.
  • the passive sheath sub-assembly comprises proximal limiting means configured for restriction of movement of the protective sleeve in the proximal direction relative to the guiding ring and arranged on the guiding ring and the protective sleeve, wherein the proximal limiting means constitute, preferably, the proximal end of the guiding ring and the distal end on the distal portion of the protective sleeve.
  • the passive sheath sub-assembly comprises guiding means configured for guiding the protective sleeve relative to the guiding ring and arranged on the guiding ring and the protective sleeve, wherein the guiding means constitute, preferably, elastic locking snaps on the guiding ring and the distal end on the distal portion of the protective sleeve.
  • the passive sheath sub-assembly is provided with an irreversible blocking mechanism of the sheath of the needle non-injection end, wherein the irreversible blocking mechanism is configured for blocking the sheath in the position sheathing the needle non-injection end with the needle point, and wherein the irreversible blocking mechanism comprises at least one technical means selected from a group comprising latching means and locking means, which latching means and locking means are arranged on the guiding ring and the protective sleeve, wherein the latching means constitute, preferably, the elastic locking snaps on the guiding ring and the distal end on the distal portion of the protective sleeve, and the locking means constitute, preferably, the elastic locking snaps and the snap-in slots on the guiding ring and the distal end on the distal portion of the protective sleeve.
  • the passive sheath sub-assembly in which the distal end of the guiding ring has a shape of an outer flange and the proximal end of the guiding ring has a shape of an inner flange, while the distal portion of the protective sleeve has a shape of a flared cup ended with the distal end in a shape of an outer flange and the proximal portion of the protective sleeve has a shape of a straight tube with a conic proximal end outer surface in the region of the proximal end of the protective sleeve.
  • the passive sheath sub-assembly in which the proximal portion of the protective sleeve, or the whole protective sleeve, is made of a material of sufficient mechanical compression strength and torsional strength as well as sufficient dimensional stability, such as metal, preferably such as stainless steel.
  • a guiding ring, according to the invention, for the needle non-injection end passive sheath sub-assembly and for the disposable sterile needle assembly, comprises the technical features of the guiding ring as described in the present description and claimed in appended claims.
  • a protective sleeve, according to the invention, for the needle non-injection end passive sheath sub-assembly and for the disposable sterile needle assembly, comprises the technical features of the protective sleeve as described in the present description and claimed in appended claims.
  • a unit package comprises the disposable sterile needle assembly with the needle non-injection end passive sheath sub-assembly, according to the invention and as described in the present description and claimed in appended claims, which are safeguarded with at least one protective component part of two component parts comprising a needle shield enclosing the injection end with the needle point of the needle tube and a needle container housing the needle assembly with the passive sheath sub-assembly, and which are safeguarded with a seal tightly closing this sterile needle assembly with the passive sheath sub-assembly.
  • a user packaging comprises a set of the unit packages according to the invention and, preferably, the pen injector with a set of the primary packagings filled up with the aseptic medicinal product, which are configured for mutual cooperation with each other in order to administer an injection of the medicinal product to a patient's body in the manner safe for the user, including exclusion of a risk of infection from blood-borne pathogens.
  • a needle-based injection system for medical use comprises the disposable sterile needle assembly with the needle non-injection end passive sheath sub-assembly, according to the invention, and the pen injector comprising the primary packaging filled up with the aseptic medicinal product, which are configured for mutual cooperation with each other in order to administer an injection of the medicinal product to a patient's body in the manner safe for the user, including exclusion of a risk of infection from blood-borne pathogens.
  • the advantage of the passive sheath sub-assembly for the needle non-injection end according to the invention is that it may be, without any substantial constructional and dimensional modifications, used in a disposable sterile needle assembly which fulfil the requirements defined by ISO 11608 Standard, and specifically as defined by Part 2 of the Standard entitled: “Needles”, that is by ISO 11608-2 Standard. Owing to this, it will be possible to apply this needle assembly with the needle non-injection end passive sheath sub-assembly, according to the invention, for cooperation with a pen injector complying with the requirements as defined by ISO 11608 Standard, and specifically as defined by Part 1 of the Standard entitled: “Needle-based injection systems ”, that is by ISO 11608-1 Standard.
  • the advantage of the needle non-injection end passive sheath sub-assembly and the sterile needle assembly comprising the needle non-injection end passive sheath subassembly, according to the invention, is that they are devoid of the above described drawbacks that are present in the known disposable needle assemblies.
  • the important advantage of the needle assembly with the needle non-injection end passive sheath sub-assembly, according to the invention, is that on one hand - mounting of the needle assembly onto the pen injector is significantly easier than in the needle assemblies known in the art, and on the other hand - sheathing of the needle non- injection end together with its end point is reliable and occurs automatically when the needle assembly is detached from the pen injector.
  • the advantage related to the present invention is easiness of manufacturing of its component parts. Owing to this and the above mentioned full compliance of the needle non-injection end passive sheath sub-assembly and the single-use sterile needle assembly, according to the invention, with the requirements determined in ISO 11608 Standard, it has been obtained the product of low manufacture costs and compatible with the pen injectors fulfilling the requirements defined by the same Standard. Further advantages and features of the present invention will be described in the following detailed description of the preferred embodiment of the invention or become clear in view of the description.
  • Fig. 1 shows a longitudinal cross-sectional view of a needle hub 1 with a needle tube 2, jointly forming a disposable sterile needle assembly according to the invention and concurrently complying with the requirements defined by ISO 11608 Standard,
  • Fig. 2 shows a longitudinal cross-sectional view of a unit package 13 with the aseptically sealed disposable sterile needle assembly provided with a needle non-injection end passive sheath sub-assembly, according to the invention
  • Fig. 3 shows an exploded perspective view of the needle hub 1 with the needle tube 2 and component parts of the needle non-injection end passive sheath sub-assembly of Fig. 2
  • Fig. 4 shows a longitudinal cross-sectional view of a protective sleeve 20 with a sheath 24 of a needle non-injection end 5 comprised in the needle non-injection end passive sheath sub-assembly of Figs. 2 - 3, in enlargement
  • Fig. 5 shows an exploded perspective view of a guiding ring 14 constituting one of the component parts of the needle non-injection end passive sheath sub-assembly of Figs. 2 - 3, in enlargement,
  • Fig. 6 shows a longitudinal half section of the guiding ring 14 of Fig. 5, in enlargement
  • Fig. 7 shows a longitudinal cross-sectional view of the disposable sterile needle assembly of Fig. 2, for better illustration - the needle assembly removed out of the unit package 13 after earlier removal of a seal 12 that closes the unit package 13, as well as a longitudinal cross-sectional view of a pen injector 26 with a primary packaging 29, after earlier removal of a crown-cap closing the pen injector 26, together constituting a needle-based injection system for medical use, prior to mounting of the needle assembly onto the pen injector 26,
  • Fig. 8 shows a longitudinal cross-sectional view of the needle-based injection system for medical use comprising the needle assembly of Fig. 2 as mounted onto the pen injector 26 and ready to perform an injection, or possibly during performing the injection,
  • Fig. 9 shows a longitudinal cross-sectional view of the disposable sterile needle assembly of Fig. 2 and a longitudinal cross-sectional view of the pen injector 26 with the primary packaging 29, after performing the injection and upon dismounting of the needle assembly from the pen injector 26.
  • the term of Volunteeraxis or ..longitudinal axis relates to the axis or another way the longitudinal axis of a needle tube 2 which is fixedly mounted in a needle hub 1 and which essentially defines the axis or the longitudinal axis of the disposable sterile needle assembly and the comprised therein needle non-injection end passive sheath sub-assembly, according to the invention, as well as the cooperating therewith pen injector 26 with the primary packaging 29.
  • the term of enquiriesaxis or ..longitudinal axis is invoked in the present description for simplification of the description of a construction and operation of the invention but with understanding that all component parts and constructional elements are not fully axially symmetric.
  • the terms ..longwise” or ..longitudinally” or ..axially relate to the axis or another way the longitudinal axis of the needle tube 2.
  • any technical means that is the component parts and the constructional elements, are ..designed for cooperation”, ..designed for cooperation with each other” or ..designed as cooperating” comprises as well such meanings as ..shaped or arranged or configured or adapted respectively for cooperation”, incidentfor mutual cooperation with each other” or ..shaped or arranged or configured or adapted respectively so that they cooperate with each other” for proper execution of respective determined functions of the individual technical means or the component parts or the structure elements of these component parts, and the whole device.
  • the needle non-injection end passive sheath sub-assembly for the disposable sterile needle assembly is ..passive” insofar as sheathing of a needle non-injection end 5 is realized automatically in the course of dismounting the disposable sterile needle assembly from a body 27 of the pen injector 26. A user does not have to perform any auxiliary actions when operating with, or handling, the needle assembly and/or the pen injector 26 in order to sheathe the needle non-injection end 5.
  • the terms as an needle injection end” and whether a needle non-injection end” relate to both ends of the needle tube 2 that is fixedly embedded in the needle hub 1 , and thus relate also to both sides of the needle assembly and both movement directions which are realized by the component parts or the constructional elements of the whole needle assembly, including the comprised therein needle non-injection end sheath sub-assembly during operation of the needle assembly, as well as to the both movement directions which are executed by the user of the whole needle-based injection system in order to perform the injection.
  • the needle injection end relates to the needle end which is inserted into a patient’s body during injection, and to the movement direction towards this patient side of the needle assembly, this end is referred also as darka distal end”.
  • the needle non-injection end relates to the needle end which is introduced into the body of the pen injector and the contained therein primary packaging filled up with the sterile medicinal product, and to the movement direction towards this pen injector side of the needle assembly, this end is referred also as sinusa proximal end”.
  • the above expressions are in effect independently of who performs the injection, that is whether the patient injects himself or herself, or whether the medical personnel administers the injection into the patient’s body, and independently of whether or not an injection is actually accomplished.
  • the terms as applieddistal and ..proximal” in the context with the other component parts or the other constructional elements relate to both sides of the needle assembly and both movement directions which are realized by the component parts or the constructional elements of the whole needle assembly, as well as to these both movement directions which are executed by the user of the whole needle-based injection system to perform the injection, that is the side or the movement direction relating, respectively, toquaintthe needle injection end” and cognitivethe needle non-injection end”.
  • the terms that the needle non-injection end 5 is implantssheathed” or that the sheath is in criza position sheathing the needle non-injection end” or “a sheathed position” mean that an end point 6 of the non-injection end 5 does not protrude outside a proximal end surface of a sheath 24, independently of whether the end point 6 is visible through an aperture 21 in the sheath 24 because of location of the end point 6 in the immediate vicinity of the proximal end surface of the sheath 24 or whether the end point 6 is not visible through the aperture 21 because of its distant, or deep, location from the proximal end surface of the sheath 24.
  • Fig. 1 shows a longitudinal cross-sectional view of the needle hub 1 with the needle tube 2 which is fixedly mounted in the needle hub 1, for example by means of an adhesive- bonded joint, which together form the disposable sterile needle assembly according to the invention and concurrently comply with the requirements defined by ISO 11608 Standard.
  • the needle tube 2 essentially defines a longitudinal axis of the needle assembly and the sheath sub-assembly as well as the whole needle-based injection system.
  • the needle tube 2 has two ends that is a needle injection end 3 with an end point 4, which is inserted into the patient’s body to administer an injection, and the needle non-injection end 5 with the end point 6, which for taking the aseptic medicinal product 31 contained in the primary packaging 29 is being screwed in a material of a wall of a barrier or a septum 30 of the primary packaging 29 arranged in the body 27 of the pen injector 26.
  • the needle hub 1 has a recess 7 which on its surface has an internal thread 9 configured for cooperation or mating with an external thread 28 provided on the body 27 of the pen injector 26, both internal and external threads 9 and 28 are designed to form a screwed connection between these component parts of the needle-based injection system, as it shown in Figs. 7 - 9.
  • the screwed connection between the needle hub 1 with the disposable sterile needle assembly and the pen injector 26 enables easy mounting of the needle assembly in the pen injector 26, which mounting is accompanied by a puncture of the septum 30 of the primary packaging 29 by means of the needle non-injection end 5 with the end point 6, and then easy dismounting of the needle assembly from the pen injector 26.
  • the internal thread 9 in the recess 7 of the needle hub 1 and the external thread 28 in the body 27 of the pen injector 26 constitute exemplary attachment means for attaching the needle hub 1 with the disposable sterile needle assembly onto the pen injector 26, which attachment means are applied in this preferable embodiment of the invention.
  • a hollow 8 configured around the longitudinal axis of the needle hub 1 , which hollow 8 is provided in its distal end with a circumferential undercut extending perpendicularly outside with relation to the longitudinal axis.
  • the circumferential undercut is configured for cooperation, or mating, with an outer flange 15 of a guiding ring 14 of the needle non-injection end passive sheath sub-assembly, according to the invention, in order to obtain between the needle hub 1 and the guiding ring 14 a non-detachable connection, which secures the guiding ring 14 relative the needle hub 1 fixedly along the longitudinal axis, as shown in Figs. 2, 4 - 5, 7 - 9.
  • the hollow 8 together with the undercut in the needle hub 1 and the outer flange 15 of the guiding ring 14 constitute exemplary fixing means for fixing the guiding ring 14 in the needle hub 1 firmly with relation to the longitudinal axis, which fixing means are applied in this preferable embodiment of the invention.
  • Fig. 2 it is shown the disposable sterile needle assembly provided with the needle non- injection end sheath sub-assembly, according to the invention, in the form as it is supplied to the user, the individual patient or the medical personnel, that is in the form of a unit package 13 which maintains the sterility of the needle.
  • the unit package 13 comprises protective component parts safeguarding the needle assembly with the sheath subassembly during transportation and assuring to the user a safe operating with the needle assembly when preparing to the injection.
  • the protective component parts comprise a needle container 11 housing the needle assembly with the sheath sub-assembly, a needle shield 10 for the needle injection end 3 and a seal 12 which tightly and aseptically closes the needle assembly with the sheath sub-assembly.
  • the seal 12 maintains the sterility of the needle assembly and is torn off from the needle assembly prior to screwing the needle assembly onto the pen injector 26.
  • the remaining protective component parts, that is the needle container 11 and the needle shield 10 for the needle injection end 3 remain during mounting of the needle assembly onto the pen injector 26 as were installed in the manufacturing process of the needle assembly and are removed only when the injection is to be performed.
  • the construction of the needle assembly with the sheath sub-assembly and the unit package 13, according to the invention, is designed so that any possibility of their again sealed closure by the seal 12 is excluded upon when the unit package 13 was open for the first time.
  • the unit package 13 once open proves that the needle assembly comprised therein lost the sterility.
  • Fig. 3 shows the exploded perspective view of the needle hub 1 with the needle tube 2 as well as the guiding ring 14 and a protective sleeve 20, which are the component parts of the sheath sub-assembly of the needle non-injection end of Fig. 2.
  • the sheath subassembly is installed in the recess 7 of the needle hub 1, that is on the side of the needle assembly configured to be attached to the pen injector 26.
  • the needle hub 1 with the hollow 8 in the recess 7, the hollow being provided at its distal end with the circumferential undercut, is designed for cooperation, during mounting of the needle assembly onto the pen injector 26, with the outer flange 15 of the guiding ring 14 and with a distal end 23 in the form of an outer flange 23 of the protective sleeve 20.
  • the guiding ring 14 is designed for cooperation with the protective sleeve 20, in order to obtain a reliable, automatic and irreversible sheathing of the needle non-injection end 5 when any, even minimal, contact of the end point 6 of the needle non-injection end 5 with the medicinal product 31 contained in the primary packaging 29 occurs upon introducing of the end point 6 through the material of the wall of the septum 30 of the primary packaging 29, in the course of attaching of the needle assembly to the pen injector 26 and then after detachment of the needle assembly from the pen injector 26, independently of whether the injection was administered or not.
  • the construction of the needle hub 1 and the construction of the sheath sub-assembly, according to the invention are in accordance with the requirements relating to the medical devices of this type and determined by ISO 11608 Standard.
  • Fig. 4 it is shown the longitudinal cross-sectional view of the protective sleeve 20 with the sheath 24 of the needle non-injection end 5 comprised in the passive sheath subassembly of the needle non-injection end of Fig. 2 - 3, in enlargement relative to the presentation of this component part of the sheath sub-assembly in Fig. 2 and 3.
  • the protective sleeve 20 is in the form of a tube with a through aperture 21 in which the non- injection end 5 of the needle tube 2 is disposed for manufacture of the needle assembly.
  • the needle tube 2 lengthwise its non-injection end 5 is slidably with clearance fitted with a proximal portion 24 of the protective sleeve 20, wherein this proximal portion 24 of the protective sleeve 20 forms the sheath 24 of the needle non-injection end 5.
  • the proximal portion 24 of the protective sleeve 20 is configured to puncture together with the needle non-injection end 5 the material of the wall of the septum 30 of the primary packaging 29 and to complete sheathing the needle non-injection end 5 after the removal of the proximal portion 24 from the primary packaging 29, and a distal portion 22 of the protective sleeve 20 from the side of the patient is configured to engage the protective sleeve 20 with the guiding ring 14 which is fixedly seated longwise the longitudinal axis in the needle hub 1.
  • the proximal portion 24 of the protective sleeve 20 is a straight tube, which outer diameter in the area of a proximal end 25 of the protective sleeve 20 decreases with configuration of a circumferential constriction with an inclination towards the needle tube 2 and with configuration of a conical proximal end outer surface of the protective sleeve 20.
  • the proximal portion 24 of the protective sleeve 20 constitutes the sheath 24 of the needle non-injection end 5.
  • the proximal end 25 of the protective sleeve 20 is designed with the conical proximal end outer surface of the protective sleeve 20 in order to facilitate puncturing of the wall material of the septum 30, typically made of rubber, of the primary packaging 29 filled up with the aseptic medicinal product 31 by means of the end point 6 of the needle non-injection end 5, and in order to facilitate pushing the proximal end 25 of the protective sleeve 20 through the wall material of the septum 30, as well as in order to configure a smooth ..passage” between the needle tube 2 and the proximal end 25 and the proximal portion 24 of the protective sleeve 20, and thereby between the needle tube 2 and the sheath 24 of the needle non-injection end 5 of the needle tube 2.
  • Such configuration of the proximal end 25 of the protective sleeve 20 with the tapered proximal end outer surface is also designed to preclude disrupting, breaking and cutting out of the material of the wall of septum 30 of the primary packaging 29, that is fragmentation of the material, during core screwing, in other words core drilling or coring, of the end point 6 of the needle non-injection end 5 and the proximal end 25 of the protective sleeve 20 into the wall material of the septum 30.
  • the distal portion 22 of the protective sleeve 20 is a tube, which in the distal direction broadens circumferentially from the longitudinal axis of the protective sleeve 20 with a deflection in the direction perpendicular relative to the longitudinal axis of the protective sleeve 20, that is in the direction outside from the needle tube 2, with configuration of a tube belling terminated with the outer flange 23.
  • the outer flange 23 extends circumferentially and perpendicularly to the longitudinal axis of the protective sleeve 20 with configuration of a flat distal end surface of the protective sleeve 20.
  • the outer flange 23 constitutes a distal end of the protective sleeve 20.
  • the distal portion 22 of the protective sleeve 20 is designed to cooperate with the guiding ring 14, as shown in Figs. 5 - 6, and in particular phases and states of operating by the user with the sterile needle assembly in cooperation with the pen injector 26, as shown in Figs. 7 - 9.
  • the distal portion 22 of the protective sleeve 20 is designed as the bell-shaped broadening with the distal end 23 of the protective sleeve 20 in the form of the outer flange 23 in order to obtain a respective engagement of the distal portion 22 of the protective sleeve 20 with the needle hub 1 and with the guiding ring 14 fixedly mounted lengthwise the longitudinal axis in the needle hub 1, before and in the course of screwing the needle non-injection end 5 together with the proximal portion 24 of the protective sleeve 20 into the material of the septum 30 of the primary packaging 29, as well as in order to appropriate guiding of the distal portion 22 of the protective sleeve 20 lengthwise the guiding ring 14 in the course of dismounting the needle assembly from the body 27 of the pen injector 26.
  • the protective sleeve 20 moves lengthwise the guiding ring 14 between its initial position and its final position.
  • the distal portion 22 of the protective sleeve 20 designed in the bell-shaped broadening is as such also determined by technological aspects of its manufacture. It is very difficult to manufacture such technological detail, that is relatively long and having a small inner diameter of the order of the tenth parts of millimetre.
  • the protective sleeve 20 it is very advantageous to design the protective sleeve 20 so that it has the straight tube configuration only at a certain required length in the region of its proximal portion 24, that is at the length with which the protective sleeve 20 is core screwed and introduced in the material of the septum 30 of the primary packaging 29 and with which length, upon screwing out of the needle assembly from the body 27 of the pen injector 26, the protective sleeve 20 creates the sheath 24 of the needle non-injection end 5. While at the remaining length of the protective sleeve 20, that is in the region of its distal portion 22, the protective sleeve 20 broadens in the bell-shaped manner facilitating manufacture of this component part.
  • a forming male mould for a female mould matrix which forges this bell-shaped portion of the protective sleeve 20, during the manufacture process is easier to be released upon formation of such distal portion 22 of the protective sleeve 20 and is shorter than it should have been required if having a different shape - whereby it is less damageable or less susceptible to fracture.
  • the through aperture 21 of the protective sleeve 20, from the side of the proximal end 25 of the protective sleeve 20 is limited by the proximal end outer surface of the protective sleeve 20, which is conically inclined towards the needle tube 2, and from the side of the distal end 23 of the protective sleeve 20 is limited by the distal end surface of the protective sleeve 20, that is the flat distal surface of the outer flange 23.
  • Fig. 5 and 6 show the guiding ring 14 being, besides the protective sleeve 20, another component part from the component parts of the passive sheath sub-assembly of the needle non-injection end of Fig. 2-3, in enlargement, and, respectively, in Fig. 5 in the perspective view and in Fig. 6 in the longitudinal half section, that is lengthwise the guiding ring 14 of Fig. 5.
  • the guiding ring 14 has the shape of essentially a cylinder with a through hole 19 in which for the assembly of the needle assembly the distal portion 22 of the protective sleeve 20 is arranged, respectively, together with the needle tube 2.
  • the guiding ring 14 is designed so that to provide technical means appropriate to fix the guiding ring 14 in the needle hub 1 immovably lengthwise the longitudinal axis, technical means appropriate to engage the guiding ring 14 with the distal portion 22 of the protective sleeve 20 and with the needle hub 1 when the protective sleeve 20 is in its initial position, technical means appropriate to guide the distal portion 22 of the protective sleeve 20 lengthwise the guiding ring 14 when the protective sleeve 20 moves towards its final position, and technical means appropriate to snap the distal portion 22 of the protective sleeve 20 in the guiding ring 14 and lock the distal portion 22 of the protective sleeve 20 in the guiding ring 14 when the protective sleeve 20 reaches its final position.
  • the proximal end 16 of the guiding ring 14 is formed as an inner flange extending perpendicularly with relation to the longitudinal axis and inwards from a cylindrical side wall of the guiding ring 14 restricting the diameter of the through hole 19 on the proximal end 16 of the guiding ring 14.
  • the distal end 15 of the guiding ring 14 is formed as an outer flange extending perpendicularly with relation to the longitudinal axis and outwards from the cylindrical side wall of the guiding ring 14.
  • the outer flange 15 of the guiding ring 14 and the hollow 8 together with the undercut of the needle hub 1 constitute exemplary fixing means for fixing the guiding ring 14 in the needle hub 1 immovably lengthwise the longitudinal axis, which technical means are applied in this preferable embodiment of the invention.
  • the cylindrical side wall of the guiding ring 14 is provided with elastic leaves in the form of springy wings, which extend longitudinally from the distal end 15 and are bent or deflected inwards the through hole 19, the elastic leaves constitute the locking snaps 17 which do not contact at the proximal end 16 with the inner flange 16 with formation of a snap-in slot 18.
  • the locking snaps 17, in this preferable embodiment of the invention are present in number of two and are arranged opposite each other.
  • the elastic or resilient leaves as the locking snaps 17, which elastically deflect outwards from the through hole 19 in the course of the movement upon them of the outer flange 23 of the protective sleeve 20 from its initial position to its final position.
  • the locking snaps 17 are configured to guide the outer flange 23 of the distal portion 22 of the protective sleeve 20 lengthwise the guiding ring 14 in the course of dismounting the needle assembly from the body 27 of the pen injector 26 and taking out of the needle noninjection end 5 from the septum 30 of the primary packaging 29.
  • the locking snaps 17 of the guiding ring 14 and the outer flange 23 of the protective sleeve 20 constitute exemplary guiding means of the protective sleeve 20 lengthwise the guiding ring 14, which are applied in this preferable embodiment of the invention.
  • the locking snaps 17 are also configured to latch the outer flange 23 of the distal portion 22 of the protective sleeve 20 in the guiding ring 14 when the protective sleeve 20 reaches its final position.
  • the locking snaps 17 and the outer flange 23 of the protective sleeve 20 are exemplary latching means of the protective sleeve 20 in its final position.
  • the locking snaps 17 are further configured to lock the protective sleeve 20 in its final position.
  • the locking snaps 17 together with the snap-in slots 18 and the inner flange 16 on the guiding ring 14 and the outer flange 23 of the protective sleeve 20 are exemplary locking means for blocking of the protective sleeve 20 in its final position, that is in the position sheathing the needle non-injection end 5.
  • the locking snaps 17 essentially contact with the distal end surface of the outer flange 23 of the protective sleeve 20, while the inner flange 16 of the guiding ring 14 essentially contacts with the surface of the outer flange 23, which is the opposite surface to the distal end surface of the outer flange 23, that is the proximal end surface thereof.
  • the guiding ring 14 is designed so that it enables its fixed seating in the needle hub 1 complying with the requirements of ISO 11608 Standard.
  • the guiding ring 14 is further designed so that the proximal portion 24 of the protective sleeve 20 protrudes outside the proximal end 16 of the guiding ring 14, and so that the proximal portion 24 of the protective sleeve 20, having the shape of the essentially straight tube, forms the sheath 24 for the needle non-injection end 5.
  • the construction of the guiding ring 14 is designed so that it provides technical means enabling displacement of the protective sleeve 20 restricted between its initial position, in which the end point 6 of the needle noninjection end 5 is unsheathed, and its final position, in which the end point 6 of the needle non-injection end 5 is sheathed.
  • the guiding ring 14 comprises as well the technical means enabling - after reaching by the protective sleeve 20 of its final position - blocking of the protective sleeve 20 in this final position so that a return of the protective sleeve 20 to its initial position is not possible.
  • Figs. 7 - 9 shown the longitudinal cross-sectional views of the single-use sterile needle assembly with the needle non-injection end passive sheath sub-assembly of Fig. 2 - 3, that is the views of the needle assembly taken outside the unit package 13 upon earlier removal of the seal 12 that closes the unit package 13, and the longitudinal cross- sectional view of the pen injector 26 with the primary packaging 29, upon earlier removal of a protective cap (not depicted in the figures) that closes the pen injector 26.
  • the needle assembly and the pen injector 26 together constitute the needle-based injection system for medical use, according to the invention.
  • the needle assembly and the pen injector 26 are illustrated in the subsequent phases and states of operating by the user with the needle-based injection system, namely in Fig.
  • the seal 12 shall be torn away from the unit package 13 comprising the sterile needle assembly and the protective cap (not depicted in the figures) tightly closing the pen injector 26 shall be torn away from the pen injector 26.
  • Fig. 7 - 8 for simplification of the illustration do not depict the remaining protective component parts of the unit package 13, which are additional to the seal 12, that is the needle container 11 and the needle shield 10 designed to protect the needle injection end 3 with the end point 4, in which the needle assembly was tightly closed in the manufacture process and then was delivered to the user as aseptically closed within the unit package 13.
  • the needle assembly shall not be taken out of these two protective component parts of the unit package 13, which safeguarding the needle assembly.
  • the needle container 11 and the needle shield 10 shall be removed from the needle hub 1 and the needle injection end 3 just only prior to performing the insertion into the patient’s body to administer the injection.
  • the pen injector 26 has the body 27 which distal end from the side of the patient is provided with the external thread 28 to establish a screwed connection with the needle hub 1 of the needle assembly.
  • the exemplary attachment means for attaching the pen injector 26 to the needle hub 1 of the needle assembly there are applied the external thread 28 on the body 27 of the pen injector 26 and the internal thread 9 in the recess 7 of the needle hub 1 of the needle assembly.
  • the primary packaging 29 containing the medicinal product 31 sealed with the septum 30.
  • the septum 30 is typically made of the rubber material and assures tight closure of the sterile medicinal product 31.
  • the primary packaging 29 may be a single-dose or multi-dose container.
  • the protective sleeve 20 with its distal portion 22, in the shape of a flared cup ended with the outer flange 23, is in the engagement with the needle hub 1 and with the outer flange 15 of the guiding ring 14 which is immovably mounted lengthwise the longitudinal axis in the needle hub 1.
  • the protective sleeve 20 remains in its initial position in which the needle non-injection end 5 is at least partly unsheathed and its end point 6 projects outside the proximal end 25 with the bevelled proximal end outer surface of the protective sleeve 20.
  • the engagement between the distal portion 22 of the protective sleeve 20 and the needle hub 1 as well as the guiding ring 14, in these states and the phase of handling the needle assembly and pen injector 26, in which the protective sleeve 20 is in its initial position consists in that the outer flange 23 simply abuts with its distal end surface against the surface of the bottom of the hollow 8 in the recess 7 of the needle hub 1 and simply contacts circumferentially with the outer flange 15 of the guiding ring 14.
  • the outer flange 23 of the protective sleeve 20 in the initial position of the protective sleeve 20 is located inside the through hole 19 of the guiding ring 14 at the distal end 15 of the guiding ring 14 and is in the contact with the distal end 15.
  • the respectively sized diameter of the through hole 19 of the guiding ring 14 and the respectively sized outer diameter of the outer flange 23 of the protective sleeve 20 are the exemplary engagement means for the engagement of the guiding ring 14 and the protective sleeve 20 in its initial position.
  • the needle assembly together with the sheath subassembly should be attached to the pen injector 26 with configuration of the screw joint between the needle hub 1 and the body 27 of the pen injector 26.
  • the end point 6 of the non-injection end 5 of the needle tube 2 penetrates the material of the wall of the septum 30 of the primary packaging 29, and the proximal end 25 of the proximal portion 24 with the proximal end outer surface of the protective sleeve 20, which proximal end outer surface is shaped as conically narrowing towards the longitudinal axis, pushes away the material until the non-injection end 5 with the needle point 6 as well as the proximal portion 24 with the proximal end 25 of the protective sleeve 20 penetrate across the septum 30 to the sterile medicinal product 31 contained in the primary packaging 29.
  • the end point 6 of the non-injection end 5 and the proximal end 25 are designed so that to minimize, firstly, the negative effects of the core screwing in, or the core drilling with rotation, or coring, the end point 6 and the proximal end 25 into the wall material of the septum 30 of the primary packaging 29 and, secondly, fragmentation of the material when the end point 6 and the proximal end 25 penetrate the wall of the septum 30.
  • the proximal portion 24 of the protective sleeve 20 has an indispensable mechanical strength, including respective deformation resistance, by means of reduction, and even elimination, of undesirable effects of concertina-wise compression and torsion of the proximal portion 24, as it is observed in case of known plastic shields for the injection ends or the non-injection ends of the needle, preferably, the proximal portion 24 with the proximal end 25 of the protective sleeve 20, forming the sheath 24, or the whole protective sleeve 20, is made of the material of respective dimensional stability, for instance of metal, preferably of stainless steel, preferably of the same type as the one of which the needle tube 2 is made.
  • the protective sleeve 20 In the course of screwing in the needle assembly onto the body 27 of the pen injector 26 and the penetration of the septum 30 of the primary packaging 29 by the end point 6 of the needle non-injection end 5 and by the proximal portion 24 of the protective sleeve 20, the protective sleeve 20 all the time remains in its initial position.
  • the axial movement of the protective sleeve 20 in the distal direction is not possible because it is restricted in this direction, wherein the protective sleeve 20 remains engaged with the needle hub 1 and with the outer flange 15 of the guiding ring 14 as abutted against and fitted snugly by its distal end 23 in the form of the outer flange 23, respectively, the bottom of the hollow 8 in the recess 7 of the needle hub 1 and into the through hole 19 at the distal end 15 in the form of the outer flange 15 of the guiding ring 14. In the initial position, the protective sleeve 20 stays in the removable contact coupling with the needle hub 1 and the guiding ring 14.
  • the non-injection end 5 with the needle point 6 of the needle tube 2 and the proximal portion 24 with the proximal end 25 of the protective sleeve 20 at a part of their lengths are situated inside the primary packaging 29 as submerged in the medicinal product 31, and at another part of their lengths are situated within the material of the septum 30.
  • the proximal portion 24 of the protective sleeve 20 at its length situated within the wall material of the septum 30, and the wall material of the septum 30 static friction is formed, which retains the proximal portion 24 of the protective sleeve 20 stationary in its embedment in the septum 30, which was obtained upon accomplishment of the attachment phase of the needle assembly onto the pen injector 26.
  • the end point 6 of the non-injection end 5 remains unsheathed and ready to transport the medicinal product 31 to the patient’s body, and the protective sleeve 20 remains in its initial position.
  • the needle-based injection system is in the stand-by state of readiness to perform the injection, as shown in Fig. 8.
  • the needle assembly After accomplishment by means of the injection end 3 with the needle point 4 of the insertion into the body of the patient and after accomplishment of the injection by means of the pen injector 26 equipped with an activation and realization mechanism of the injection, the needle assembly is being unscrewed from the body 27 of the pen injector 26.
  • the needle hub 1 together with the needle tube 2, which is fixedly embedded therein, and with the guiding ring 14, which is fixedly seated therein and lengthwise the longitudinal axis, displace in the distal direction relative to the body 27 of the pen injector 26 till detachment of the screwed connection between the needle assembly and the pen injector 26 is obtained.
  • the proximal portion 24 of the protective sleeve 20 having the shape of an essentially straight tube, is being hold stationary in the septum 30 in this its embedment which was obtained after accomplishment of the attachment phase of the needle assembly onto the pen injector 26, owing to the static frictional force created between this proximal portion 24 and the material of the septum 30. Therefore, also the whole protective sleeve 20 remains stationary in this embedment of its proximal portion 24 in the septum 30, which was obtained after accomplishment of the attachment phase of the needle assembly onto the pen injector 26.
  • the outer flange 23 of the protective sleeve 20 loses abutment with its distal end surface against the bottom of the hollow 8 in the recess 7 of the needle hub 1 and loses the circumferential contact with the outer flange 15 of the guiding ring 14, and the engagement between the distal portion 22 of the protective sleeve 20 and the needle hub 1 as well as the outer flange 15 of the guiding ring 14, which engagement was guaranteed by the construction of the needle assembly according to the invention in the initial position of the protective sleeve 20, is released.
  • the guiding ring 14 moves axially in the distal direction and relative to the pen injector 26 together with the needle hub 1, and the locking snaps 17 of the guiding ring 14 guide the outer flange 23 of the protective sleeve 20 until the latch of the outer flange 23 in the snap-in slots 18 is reached, and which latch occurs when the protective sleeve 20 reaches its final position.
  • the proximal portion 24 of the protective sleeve 20 having the shape of the essentially straight tube, is retained stationary in the septum 30 in this its embedment which was obtained after accomplishment of the attachment phase of the needle assembly onto the pen injector 26, owing to the static friction force created between the proximal portion 24 and the material of the septum 30 of the primary packaging 29.
  • the locking snaps 17 of the guiding ring 14 guide the outer flange 23 of the protective sleeve 20, which outer flange 23 displaces axially in the proximal direction and relative to the needle hub 1, till its latch in the snap-in slots 18 of the guiding ring 14, which occurs when the protective sleeve 20 reaches its final position.
  • the proximal portion 24 of the protective sleeve 20 having the shape of the essentially straight tube, moves axially in the proximal direction lengthwise and relative to the needle hub 1 and relative to the needle tube 2 with the needle non-injection end 5, which needle tube 2 is fixedly embedded in the needle hub 1, until the final position of the protective sleeve 20 is reached.
  • the non-injection end 5 together with the needle point 6 is sheathed.
  • its proximal portion 24 becomes the sheath 24 for the needle non-injection end 5.
  • the protective sleeve 20 moves in the proximal direction relative to the guiding ring 14 from its initial position, that is the unsheathed position of the needle non-injection end 5, to its final position, that is the sheathed position of the needle non-injection end 5, and remains in this final position without any possibility to return to the initial position.
  • the protective sleeve 20 When the screwed connection between the needle hub 1 and the body 27 of the pen injector 26 is completely disconnected, the protective sleeve 20 is already in its final position and in this position is irreversibly locked against any axial movement.
  • the distal end 23 in the shape of the outer flange on the distal portion 22 of the protective sleeve 20 is axially guided lengthwise the elastic locking snaps 17, which locking snaps 17 deflect outside perpendicularly from the longitudinal axis and tighten, until the engagement of the distal end 23 with the proximal end 16, in the form of the inner flange, of the guiding ring 14 is reached.
  • the outer flange 23 of the protective sleeve 20 falls into the snap-in slots 18 configured in the guiding ring 14 above the locking snaps 17 and underneath the inner flange 16 of the guiding ring 14, the locking snaps 17 deflect inwardly perpendicularly to the longitudinal axis and return to their non- tight, or not tense or loose, initial position in which they were before commencement of the detachment phase of the needle assembly from the pen injector 26.
  • the outer flange 23 of the protective sleeve 20 is snapped between the locking snaps 17 and the inner flange 16 of the guiding ring 14.
  • the protective sleeve 20 remains without any possibility to realize any axial movement. This is the final position of the protective sleeve 20, in which the noninjection end 5 together with the needle point 6 is sheathed.
  • the irreversible locking of the protective sleeve 20 in its final position will take place always upon when the needle assembly is detached from the pen injector 26 and always when in the course of forming the screwed connection between the needle assembly and the pen injector 26, that is in the course of the attachment phase of the needle assembly onto the pen injector 26, the proximal portion 24 of the protective sleeve 20 penetrating the wall material of the septum 30 of the primary packaging 29 is at any its length screwed together with the needle point 6 of the needle non-injection end 5 in the material of the septum 30, because the proximal portion 24 will be then immobilized by the friction force in the material of the septum 30. In the same conditions, the sheathing of the needle non-injection end 5 by the proximal portion 24 of the protective sleeve 20 will always occur as well.
  • the guiding of the axial movement of the protective sleeve 20 relative to the guiding ring 14, which is realized in the detachment phase of the screwed connection between the needle assembly and the pen injector 26, or in the detachment phase of the needle assembly from the pen injector 26, is guaranteed by the guiding means configured on the guiding ring 14 and on the protective sleeve 20, respectively for mutual cooperation with each other.
  • the axial movement that is the movement lengthwise the longitudinal axis, of the protective sleeve 20 relative to the guiding ring 14 and the needle hub 1 , in which hub the guiding ring 14 is fixedly embedded lengthwise the axis, in the distal direction is restricted by the needle hub 1 and in the proximal direction is restricted by the guiding ring 14.
  • the protective sleeve 20 moves between its initial position and its final position, which movement takes place in the detachment phase of the needle assembly from the pen injector 26.
  • the protective sleeve 20 remains in its initial position in the course of preparations of the needle assembly for attaching to the pen injector 26, that is in the state prior to the attachment of the needle assembly to the pen injector 26, and then in the course of the attachment phase of the needle assembly onto the pen injector 26 and in the stand-by state of readiness to administer the injection, while the protective sleeve 20 remains in its final position after the detachment of the needle assembly from the pen injector 26.
  • distal limiting means designed on the needle hub 1 and on the protective sleeve 20, respectively for mutual cooperation with each other.
  • the distal limiting means assists the engagement means of the protective sleeve 20 and the guiding ring 14 in holding the protective sleeve 20 in its initial position, that is in the unsheathed position of the needle non-injection end 5.
  • proximal limiting means designed on the guiding ring 14 and on the protective sleeve 20, respectively for mutual cooperation with each other.
  • proximal end 16 in the form of the inner flange 16 on the guiding ring 14
  • distal end 23 in the form of the outer flange 23 on the protective sleeve 20.
  • the proximal limiting means stops the protective sleeve 20 in its final position, which position is reached by the protective sleeve 20 when detaching the needle assembly from the pen injector 26.
  • Non-reversible locking of the protective sleeve 20 in its final position, that is in the sheathed position of the needle non-injection end 5 with the needle point 6, is guaranteed by latching means and locking means designed on the guiding ring 14 and on the protective sleeve 20, respectively for mutual cooperation with each other.
  • This preferable embodiment of the invention as being described in the present disclosure is equipped with both the guiding means and the latching means, as well as with the locking means, comprising also the proximal limiting means, configured on the guiding ring 14 and on the protective sleeve 20, respectively to mutually cooperate with each other, which functions and the exemplary construction were described above, and which form the irreversible blocking mechanism of the sheath of the needle non-injection end in the sheathed position of the needle non-injection end 5 with the needle point 6, that is when the protective sleeve 20 reaches its final position.
  • the construction of the passive sheath sub-assembly of the needle non-injection end according to the invention was designed for cooperation with the needle hub 1 fulfilling the requirements relating to the medical devices of this type, which are determined by ISO 11608 Standard, and concurrently the construction of the needle hub 1 was modified, respectively for cooperation with the sheath sub-assembly according to the invention.
  • this structural modification did not include any dimensional adaptation of the needle hub 1 in the manner which would negatively interfere in the conformity with the requirements of ISO 11608 Standard.
  • the needle assembly and the needle-based injection system were obtained, which fulfil all requirements of ISO 11608 Standard, including the requirement of lubrication of the needle tube 2 at its both injection and non-injection ends, 3 and 5, during the manufacture process of the needle assembly.
  • the needle assembly according to the invention it means that during the manufacture process - besides lubrication of the injection end 3 of the needle tube 2, the proximal portion 24 of the protective sleeve 20 is also lubricated, as in the course of the attachment phase of the needle assembly onto the pen injector 26, the proximal portion 24 of the protective sleeve 20 pierces the material of the septum 30 and then becomes the sheath 24 for the needle non-injection end 5.
  • the outer surface of the proximal portion 24 of the protective sleeve 20 is lubricated. Owing to the construction of the sheath sub-assembly and the construction of the needle assembly designed in the present invention, despite lubrication of the proximal portion 24 of the protective sleeve 20, the needle-based injection system according to the invention operates reliably guaranteeing the sheathing of the needle non-injection end 5 after any, even minimal, introducing of the end point 6 of the needle non-injection end 5 through the wall material of the septum 30 of the primary packaging 29 into the contact with the medicinal product 31 contained in the primary packaging 29, in the course of attaching the needle assembly to the pen injector 26 and then after detachment of the needle assembly from the pen injector 26.
  • the reliable operation of the needle- based injection system is guaranteed even in the case when in the manufacture process of the needle assembly according to the invention, on the injection end 3 of the needle tube 2 and on the proximal portion 24 of the protective sleeve 20, there are applied lubrication agents of the best characteristics.
  • the sheath 24, or the whole protective sleeve 20 is made of metal, preferably of stainless steel, the most preferably of the same stainless steel as the needle tube, for example of the stainless steel determined by ISO 9626 Standard.
  • the sliding friction force between the sheath 24 of the needle noninjection end 5 and the septum 30 in the course of attaching the needle assembly onto the pen injector 26 is substantially lesser in comparison with the analogous force that is observed in the known needle assemblies, but concurrently the static friction force between the sheath 24 of the needle non-injection end 5 and the septum 30 is always higher than the friction force between the sheath 24 and the non-injection end 5 and is sufficient to assure the sheathing of the needle non-injection end 5.
  • mounting of the needle assembly onto the pen injector 26 is significantly easier than in the known needle assemblies with the sheath for the needle non-injection end, wherein holding of the sheath 24 by the septum 30 of the primary packaging 29 during dismounting of the needle assembly from the pen injector 26 is reliable and the sheathing of the needle non-injection end 5 with the needle point 6 is reliable as well.
  • the needle assembly and the needle-based injection system, according to the invention which assure reliable, automatic and non-reversible sheathing of the needle non-injection end 5 already when any, even minimal, contact of the end point 6 of the needle non-injection end 5 with the medicinal product 31 contained in the primary packaging 29 occurs during mounting the needle assembly onto the pen injector 26, and then after removal of the needle assembly from the pen injector 26, independently of whether the injection was finally performed or not.
  • the present invention provides the needle assembly with the needle non-injection end passive sheath sub-assembly and the needle-based injection system, such that the user when handling them, after detachment of the needle assembly from the pen injector 26, cannot experience a needle stick injury by the needle point 6 of the needle non-injection end 5, which needle point 6 was in the contact with the medicinal product 31.
  • the present invention eliminates a risk of infection of the user by the needle non-injection end 5, in the case when during inserting the needle injection end 3 into the patient’s body an unintentional insertion into a blood vessel takes place and contamination of the needle non-injection end 5 and the medicinal product 31 contained in the primary packaging 29 by the patient’s blood takes place as well.
  • the construction of the needle non-injection end passive sheath sub-assembly according to the invention was designed for cooperation with the needle hub 1 complying with the requirements defined by ISO 11608 Standard, and concurrently the construction of the needle hub 1 was modified, respectively, for cooperation with the sheath sub-assembly according to the invention.
  • the adaptation of the needle hub 1 for cooperation with the needle non-injection end sheath sub-assembly according to the invention encompasses providing the respective fixing means to seat the guiding ring 14 in the needle hub 1 stationary lengthwise the longitudinal axis and the respective limiting means to restrict axial movement of the protective sleeve 20 in the proximal direction relative to the guiding ring 14 and the needle hub 1.
  • the needle hub 1 fulfilling the requirements defined by ISO 11608 Standard, was modified for cooperation with the sheath subassembly according to the invention, by the design of the hollow 8 in the recess 7 of the needle hub 1.
  • the hollow 8 is provided at its distal end with the circumferential undercut extending perpendicularly outwardly relative to the longitudinal axis. From the technological point of view, this adaptation of the needle hub 1 is not any serious intervention into the structure of the needle hub 1 complying with ISO 11608 Standard, which is a significant advantage furnished by the present invention to manufacturers of the disposable medical devices of this type.
  • This constructional modification does not encompass any dimensional adaptation of the needle hub 1 in the manner which would negatively interfere with the requirements of ISO 11608 Standard.
  • this constructional modification in any way does not affect the operation of the needle assembly if it could be manufactured without mounted therein the needle non-injection end passive sheath sub-assembly according to the invention, that is manufactured as the needle assembly complying with ISO 11608 Standard but without sheathing of the needle non-injection end.

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

Abstract

L'invention concerne un sous-ensemble de gaine passive de non-injection d'aiguille destiné à un ensemble aiguille stérile jetable qui est conçu pour coopérer avec un injecteur de type stylo (26) et un boîtier primaire contenu dans celui-ci (29) rempli d'un produit médicinal aseptique (31), formant ensemble un système d'injection basé sur une aiguille à usage médical, NIS. La présente invention concerne également une bague de guidage (14) et un manchon de protection (20) en tant que parties constitutives du sous-ensemble de gaine passive, ainsi qu'un boîtier unitaire (13), l'ensemble aiguille scellé de manière aseptique et un boîtier d'utilisateur comprenant une collection des boîtiers unitaires (13) et, de préférence, l'injecteur de type stylo (26). Le sous-ensemble de gaine passive est monté dans un évidement (7) d'une embase d'aiguille (1) de l'ensemble aiguille, sensiblement autour d'une extrémité de non-injection d'aiguille (5) d'un tube d'aiguille (2) et est configuré pour gainer automatiquement l'extrémité de non-injection d'aiguille (5) avec un point d'extrémité (6) après la séparation de l'ensemble aiguille et de l'injecteur de type stylo (26).
PCT/IB2021/059311 2020-10-12 2021-10-12 Sous-ensemble de gaine passive d'extrémité de non-injection d'aiguille et ensemble aiguille de type stylo de sécurité WO2022079576A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PL435654A PL435654A1 (pl) 2020-10-12 2020-10-12 Podzespół pasywnej osłonki końcówki nieiniekcyjnej igły i zespół sterylnej igły jednorazowego użytku z podzespołem pasywnej osłonki końcówki nieiniekcyjnej igły, oraz części składowe zawarte w tym podzespole pasywnej osłonki końcówki nieiniekcyjnej igły i produkty medyczne zawierające ten zespół sterylnej igły jednorazowego użytku z tym podzespołem pasywnej osłonki końcówki nieiniekcyjnej igły
PLP.435654 2020-10-12

Publications (1)

Publication Number Publication Date
WO2022079576A1 true WO2022079576A1 (fr) 2022-04-21

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PCT/IB2021/059311 WO2022079576A1 (fr) 2020-10-12 2021-10-12 Sous-ensemble de gaine passive d'extrémité de non-injection d'aiguille et ensemble aiguille de type stylo de sécurité

Country Status (2)

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PL (1) PL435654A1 (fr)
WO (1) WO2022079576A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110152822A1 (en) * 2008-05-24 2011-06-23 Annette Drunk Ampoule comprising an ampoule holder
US20120150128A1 (en) * 2010-12-09 2012-06-14 Becton, Dickinson And Company Pen needle assembly with different gauge needle cannulas
EP2517747A2 (fr) * 2011-04-28 2012-10-31 Becton, Dickinson and Company Ensemble d'aiguille de sécurité
WO2016196518A1 (fr) * 2015-06-01 2016-12-08 Becton, Dickinson And Company Aiguille-stylo jetable à extrémité non-patient abrégée, et interface de stylo réutilisable
WO2019157176A1 (fr) * 2018-02-12 2019-08-15 Becton, Dickinson And Company Système d'aiguille de stylo

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110152822A1 (en) * 2008-05-24 2011-06-23 Annette Drunk Ampoule comprising an ampoule holder
US20120150128A1 (en) * 2010-12-09 2012-06-14 Becton, Dickinson And Company Pen needle assembly with different gauge needle cannulas
EP2517747A2 (fr) * 2011-04-28 2012-10-31 Becton, Dickinson and Company Ensemble d'aiguille de sécurité
WO2016196518A1 (fr) * 2015-06-01 2016-12-08 Becton, Dickinson And Company Aiguille-stylo jetable à extrémité non-patient abrégée, et interface de stylo réutilisable
WO2019157176A1 (fr) * 2018-02-12 2019-08-15 Becton, Dickinson And Company Système d'aiguille de stylo

Also Published As

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