Safety pen needle assembly with active sheath

Abstract

The present application relates to an active sheath subassembly for the needle injection end (3) of a disposable sterilized needle assembly dedicated to use with a pen syringe (42), the active sheath subassembly comprising a primary package (45) containing a sterile medical product (47), together constituting a medical needle injection system. Five variations of a needle injection end active sheath subassembly are disclosed. The present application also relates to component parts of a needle injection end active sheath subassembly, i.e. An immovable component part (14), a first movable component part (15) and a second movable component part (16), as well as a unit package (13) of a needle assembly comprising such a sterile package and a user package comprising a set of said unit packages (13), and preferably a pen syringe (42). The sheath subassembly is mounted on a hub (1) of the needle assembly and is configured to activate a cladding of a needle injection end (3) with an end point (4) and / or a needle non-injection end (5) with an end point (6) prior to detaching the needle assembly from a pen syringe (42). Furthermore, the present application relates to a disposable sterilized needle assembly provided with a needle injection end active sheath subassembly according to the present application, and a medical needle injection system provided with a disposable sterilized needle assembly according to the present application.

Description

TECHNICAL FIELD

[0001] The present application relates to a needle injection end active sheath sub-assembly for a single-use sterilized needle assembly designed for use in cooperation with a reusable pen-injector and wherein a primary package containing a sterile medicament is comprised, jointly forming a medical needle injection system.

[0002] The present application also relates to a single-use sterilized needle assembly provided with a needle injection end active sheath sub-assembly according to the present application, and to a medical needle injection system provided with a single-use sterilized needle assembly according to the present application.

[0003] The present application also relates to the component parts of a needle injection end active sheath assembly, namely an immobile assembly, a first movable assembly and a second movable component part, respectively relating to variants of a needle injection end active sheath assembly according to the present application.

[0004] Further, the present application relates to a unit package with a single-use sterilized needle assembly according to the present application having a sterile seal, and to a user package comprising a set of unit packages according to the present application and preferably a user package comprising a pen-injector. BACKGROUND

[0005] Medical needle injection systems (NIS, needle injection medical systems) are known which are designed for parenteral administration of a medicament by means of a pen-injector and a single-use sterilized needle for subcutaneous injection. Medical needle injection systems are becoming more and more popular because they can be easily and independently used by a single patient. The medicament, which can be an antihistamine, a human growth hormone, an osteoporosis drug, an antithrombotic drug, a botulinum toxin, a chronic migraine drug, a painkiller or an insulin, is sterilely sealed in a primary package provided in the pen-injector and is accurately injected into the patient's body using the needle injection system.

[0006] A pen-injector, also called "pen" or "cartridge", is a disposable or reusable injection device which comprises a non-replaceable or replaceable primary package containing a dose-appropriate and sterile medicament for use in cooperation with a single-use sterilized needle. The primary package is sometimes also called "cartridge" or tightly closed ampoule or vial. The primary package has a barrier, also called "septum" or "cartridge septum", which is usually in the form of a rubber membrane or a bung and tightly closes the sterile medicament contained in the package. The primary package can be a single-dose or multi-dose container, in other words a single- or multi-chamber container, or also called a single- or multi-compartment container. The pen-injector and the primary package containing the medicament contained therein are closed by a protective cap.

[0007] A sterile disposable needle, often also referred to as "pen needle" or "safety pen needle" or "injection pen needle", is designed for use with a pen injector and its contained primary packaging and is in the form of a needle assembly. The needle assembly typically comprises a needle cannula, a hub with attachment means for attaching the needle assembly to the pen injector, a protective component in the form of a needle shield and a seal. The sterile disposable needle is double ended, the injection end being on the patient side for insertion into the patient's body and the non-injection end being on the pen injector side for piercing the barrier of the primary packaging and receiving the drug contained in the packaging. The seal is a removable tight barrier for ensuring the sterility of the needle.

[0008] The tip of the injection end, also referred to as "needle tip", has to be configured to minimize the pain caused when inserting the tip into the patient's body. The needle tip of the non-injection end has to be configured in order to: first, minimize the negative effects of the core spinning, also referred to as coring or taking, when the needle tip pierces the primary packaging barrier wall material; second, minimize the fragmentation of the primary packaging barrier wall material when the needle non-injection end tip penetrates the primary packaging barrier wall. According to the requirements for such medical devices, which are defined by the ISO 11608 standard under the general title: "Medical pen injection systems - Requirements and test methods", in order to minimize the pain sensation upon insertion and to minimize the coring and fragmentation of the barrier wall material, the needle cannula should be lubricated at the injection end on the patient side and at the non-injection end on the pen injector side. The lubricant should not be present on the outer surface of the needle cannula in the form of droplets, neither under normal vision nor under corrected to normal or supported or assisted vision.

[0009] The sterile sealed needle assembly constitutes a unit package or unitized packaging to maintain the sterility of the needle. The needle assembly in the unit package has to be subjected to a validated sterilization process, i.e. a process proven to comply with the recognized requirements. According to the requirements applicable to such medical devices, the needle assembly has to be installed onto the pen injector without removing the seal first and without removing the needle assembly from the opened unit package. The materials used and the design of the needle assembly and the unit package must not have any detrimental effect on the contents of the unit package and must ensure the sterility preservation of the needle assembly during typical handling, transportation and storage. Furthermore, the design of the needle assembly and the unit package must exclude any possibility of resealing the unit package with the seal upon the first opening of the unit package so that once opened, the unit package is evidence that the needle assembly contained therein has lost its sterility.

[0010] The unit package with the sterile needle is usually provided to the patient or to the medical staff in the form of a user package comprising a set of unit packages each having needle assemblies of the same type and from the same production batch.

[0011] Accidental needle stick injuries with contaminated medical needles pose a serious risk of infection with blood-borne pathogens, including the hepatitis B and C viruses and the Human Immunodeficiency Virus ("HIV") to patients and medical personnel, especially nurses. Accidental needle stick injuries with contaminated medical needles occur primarily when the sterile medical needle assembly is removed from the pen-injector after administering a dose to a patient and is thrown into a medical waste container. Accidental needle stick injuries are particularly likely to occur when the needle assembly is re-protected after removal from the pen-injector, if the needle assembly is provided in a unit package and the needle tip is protected by external protection components, i.e. a needle container and a needle shield.

[0012] Today, patients and medical personnel are highly aware of the great danger of accidental needle stick injuries with the injection end just after use. However, until recently, this awareness was not present with regard to the non-injection end of the needle on the side of the pen-injector. It was always assumed that the non-injection end of the needle was sufficiently encapsulated so that an accidental contact of the fingers of the user with the non-injection end of the needle during handling of the needle assembly and the needle-injector system did not pose a significant risk, since this is the end which is inserted into the primary packaging together with the drug for administration and thus does not come into contact with blood. At the same time, it has been proven that, if the needle injection end is accidentally inserted into a blood vessel during insertion into the patient, blood from the blood vessel, under the influence of arterial pressure, can pass through the needle tube into the primary packaging and contaminate its contents, and also pose an infection risk to the user through the non-injection end of the needle which has entered the primary packaging and is then removed from the primary packaging.

[0013] In the technical field, the technical problem of protecting the non-injection end of a disposable sterile needle from accidental contact with the fingers of the user after removal from the primary packaging has been addressed. Attempts have been made to design such assemblies of disposable sterile needles to solve this problem. However, known needle assembly solutions have a number of disadvantages, which will be described in detail below. These disadvantages consist essentially in that the needle assemblies provided are not reliable devices and, in the event of improper handling, it is very likely that the non-injection end will not be covered to the required degree of safety for the user.

[0014] From the patent document US 3 658 061 it is known that a needle shield assembly is used for insertion into a vein of a patient for parenteral administration of liquid through a catheter or a venous indwelling needle tube. The document describes a needle end shield for insertion into a vein of a patient, which is pivotally connected to a needle hub. Once the catheter or venous indwelling needle is placed into the vein and the needle is removed from the patient, the shield is rotated relative to the needle hub into its position along the needle, in which the end of the needle is covered. This document is suitable for a venous needle assembly with a single shield for the needle end in the patient side.

[0015] International publication WO 91 / 18635 Al discloses a reusable assembly that prevents accidental contact with the surface and the needle tip and is designed for syringes and other invasive medical devices. Various forms of sheaths are shown in this document, which are pivotally or fixedly attached to the needle hub, are flexibly bent to perform the needle operation and then cover the needle after use. Various means for locking the sheaths in place to protect the surface and the needle tip are also described. This document solves the problem of covering the needle and other invasive medical devices with a single tip.

[0016] Patent document US4664259A discloses a sheath solution for syringe needles, which are called needle packages and they ensure that the needle is sterile before use, but also prevent accidental contact with the needle after use. The needle sheath is pivotally attached to the needle hub, so that the sheath can be displaced from a first position, in which it covers the sterilized needle, to a second position, in which the needle is extracted for use, and then to a third position, in which it covers the used needle. The needle sheath comprises locking means for locking the sheath on the needle after use of the needle. The sheath can be single-part or double-part and it wraps the needle and its tip before and after the needle is ready for use. This document is suitable for needle sheaths of syringes, the needles of which have a single tip for insertion into the patient's body. Patent documents EP 2 839 854 B1 and US 2011 / 0257603 indicate that, after performing an injection, it is necessary to cover the injection end and the non-injection end of the needle. A disposable sterile safety needle assembly is disclosed in these documents, which is an advanced design mechanism. This needle assembly is provided with a double passive sheath subassembly for the injection end and the non-injection end of the needle, which automatically covers the injection end and the non-injection end after the injection is completed and when the needle assembly is removed from the pen-type syringe.

[0017] The needle non-injection end sheath remains in its initial position, in which the non-injection end is not covered, and departs from this position under the force of the expansion spring when the needle assembly is removed from the pen-type syringe body after the injection is completed, until the sheath reaches its position after use, in which the non-injection end is covered. In this solution of the needle assembly, the activation of the needle non-injection end sheath is kinematically connected with the injection end sheath and is only possible when the activation of the injection end sheath is performed, which occurs after the injection is completed and after the needle assembly is removed from the pen-type syringe. Therefore, the needle non-injection end sheath is activated only if the following sequence of operations is performed: "screwing the needle assembly onto the injection pen body" -> "injection into the patient's body" -> "screwing the needle assembly out of the pen-type syringe needle". In other words, screwing the needle assembly into the pen-type syringe and screwing it out, without puncturing and injecting the patient's body, does not result in covering the needle injection end or covering the needle non-injection end.

[0018] The needle assembly is a complex mechanism comprising numerous components and structural elements. Furthermore, the possibility of injury to the patient or healthcare worker remains even when the needle assembly is attached to a pen syringe and then removed without the needle being inserted into the patient.

[0019] Furthermore, the needle assembly includes a spring whose proper operation determines the correct operation of the entire needle assembly and is therefore crucial to user safety. Using springs or spring elements made of metal or plastic is disadvantageous, especially in designs where these springs or spring elements are required to remain tensioned from the time the safety needle assembly is assembled until operation. This is because plastic spring components may permanently deform during product storage, rendering the product unreliable and unsuitable for medical applications, while metal spring elements are also undesirable for economic and disposal reasons.

[0020] As disclosed in patent document number US 5,314,503, a sub-assembly of a passive sheath for the tip of a disposable surgical needle is designed for use with a syringe used to puncture a patient's tissue to inject medication or aspirate fluid from the patient. The passive sheath sub-assembly for the tip of the disposable surgical needle provides a protective sheath that automatically covers the tip of the needle when it is withdrawn from the patient.

[0021] The structure and material composition of the sheath and needle are such that the sliding friction between the outer surface of the sheath and the patient's body tissue exceeds the sliding friction between the inner surface of the sheath and the outer surface of the needle, and preferably also exceeds the force required to engage the locking mechanism to hold the sheath in a position covering the needle tip. This excess sliding friction is sufficiently high that when the needle is removed from the patient's body, the sheath is retained by the patient's tissue until the needle tip is completely withdrawn from the tissue, and preferably also until the locking mechanism engages automatically or manually. Upon withdrawal of the needle tip and sheath from the patient's body, the tip is automatically positioned within the sheath, and preferably the sheath is locked in a position covering the needle tip.

[0022] In the context of this disclosure, another aspect of the passive sheath subassembly for the needle injection tip relates to standard medical practice applied when performing subcutaneous injections—in other words, injections "into tissue," i.e., not deep injections, typically entering skin folds, such as insulin or botulinum toxin injections—and when performing intramuscular injections, i.e., deep injections. When these types of injections are involved, medical personnel always check that no vein or artery has been inserted. This check involves a small aspiration of the syringe plunger and observation for any aspiration of blood. If this is the case, the medical personnel slightly withdraw the needle from the tissue, rather than withdrawing it from the patient and repeating the insertion at a slightly altered angle. With the passive sheath subassembly for the needle injection tip, this practice can result in the needle injection tip being covered during the "small aspiration," triggering the mechanism that locks the sheath in the covered position, thus preventing the needle from being inserted at a different angle. This would prevent the intended injection from being performed using a disposable needle assembly already in use, and would necessitate another insertion using a new needle assembly. This adverse situation does not occur when using the sheath assembly according to this application.

[0023] International Patent Application No. WO2016 / 196518 A1 discloses a disposable sterile needle assembly with a component for detachable coupling to the body of a pen syringe. This document raises the issue that the non-injection needle tip poses a high risk of needlestick injury to the user when the sterile needle tip assembly is attached to and removed from the pen syringe, and during storage and disposal of used needle tips. To address this issue, the document proposes several types of needle assemblies with a concealed or shortened non-injection needle tip that does not protrude beyond a recess formed in the needle hub proximal to the side of the pen syringe. The concealed or shortened non-injection needle tip is not intended to puncture the septum of the primary packaging containing sterile medication.

[0024] The needle assembly requires a reusable interface component made of plastic for detachable connection to the pen syringe. This reusable interface component acts as an intermediate member between the needle assembly and the pen syringe, and is adapted to pierce the septum of the primary packaging to allow the medication to flow proximally towards the needle assembly, i.e., towards the injection end. When the component used for detachably coupling the needle assembly to the pen syringe body is mounted on the pen syringe, and then after the injection is completed and the needle assembly is disengaged, a press-fitting cap is needed to protect the groove formed at the distal end of the interface component used for detachable connection, i.e., from the side of the needle assembly, to prevent leakage of any remaining medication from the primary packaging.

[0025] Before reusing the pen syringe and before engaging another disposable needle assembly, the cap needs to be removed from the groove in the interface member for detachable connection. This needle assembly engages with a separate component for detachably connecting the needle assembly to the pen syringe body, and the separate cap, as an integral part, is necessary for servicing and effective interoperability with the pen syringe for injection, requiring the user to perform several specialized steps. This needle assembly is an impractical and cumbersome solution.

[0026] As described in patent specification number EP 1 949 927, a disposable sterile needle assembly includes a passive sheath subassembly for the non-injection end of the needle. The component covering the non-injection end is threadedly installed in a groove formed in the needle hub for receiving a pen syringe. The thread of the component covering the non-injection end is identical to the thread of the pen syringe. The covering component has an attachment device for quick connection to the pen syringe. After the pen syringe is screwed into the groove of the needle hub, it should form a non-removable connection with the covering component so that when the syringe is unscrewed after injection, the covering component rotates together with the syringe and moves proximally until it completely covers the non-injection end.

[0027] In this needle assembly solution, to achieve coverage of the non-injection end of the needle, the pen syringe must be screwed into the groove of the needle hub until it is fully screwed in, i.e., until a quick connection is achieved between the pen syringe body and the covering member of the needle assembly. If the pen syringe is not screwed into the groove of the needle hub until fully screwed in, the covering member will not achieve a quick connection with the pen syringe; it will neither rotate with it nor move proximally, thus preventing coverage of the non-injection end. However, even without fully screwing the pen syringe into the groove of the needle hub, the non-injection end will puncture the septum of the primary packaging, which tightly seals the sterile drug contained within the primary packaging. This allows for injection; however, after injection, there is no need to cover the non-injection end of the needle. Furthermore, if the pen syringe is not fully screwed into the groove of the needle hub, i.e., a fixed connection is not achieved between the pen syringe and the covering member, the non-injection end of the needle will be contaminated. However, after unscrewing the needle assembly from the injection pen, the contaminated non-injection end of the needle will not be covered.

[0028] For the safety needle assembly to function properly, with the non-injection end of the needle covered after injection, the user must prepare the needle assembly and pen syringe in a manner specifically designed for that needle assembly. However, this is not always the case, nor is it always feasible. The effective realization of the intended function of the safety needle assembly depends on the user's correct handling of the needle assembly and pen syringe.

[0029] A utility model of a disposable sterile needle assembly for insulin injection is known from patent document CN210228813U. This assembly includes an injection end sheath pivotally attached to the needle hub, such that after injection, the sheath is moved by the user's finger to its locked position, where it covers the injection end. In this utility model, during preparation for injection, particularly when the sheath is tilted proximally towards the needle injection end on the hinge, i.e., towards the pen syringe handle, to expose the needle injection end, these preparation steps must be performed manually, which easily leads to accidental needlestick injuries. Furthermore, throughout the entire operation of the needle assembly—before, during, and after injection, and also during its attachment to and removal from the pen syringe—the injection end sheath can freely rotate on the hinge towards the proximal end of the needle tip and towards the proximal end of the pen syringe handle, making the product cumbersome to operate and increasing the risk of user injury. Furthermore, when the needle tip sheath is attached to the needle hub and shaped as shown in the attached figure, it may be relatively easy to damage the sheath during operation of the product, posing another significant hazard to the user and patient. This utility model of the needle assembly relates to a single sheath covering the needle tip from the patient side.

[0030] In addition to the aforementioned technical issues related to disposable sterile needles used with reusable pen syringes, economic challenges have emerged in this field in recent years. This is because healthcare institutions worldwide have been severely impacted by the COVID-19 pandemic and are currently facing serious financial difficulties. Furthermore, economic instability and rising inflation rates exist in many countries and regions globally. Consequently, those responsible for healthcare finances are seeking to save money and find medical products that incorporate reliable and internationally compliant technological solutions at a significantly lower cost. Therefore, it has been observed that the economic aspects of medical product selection have become increasingly important in recent years, especially for devices such as disposable sterile needles used in mass healthcare applications. Summary of the Invention

[0031] The purpose of this application The purpose of this application is to design a reliable active needle tip sheath subassembly for use with a pen syringe and its primary packaging to form a medical needle injection system. The structure and dimensions of the active needle tip sheath subassembly and the disposable sterile needle assembly will ensure interference-free fitting with the pen syringe and meet the requirements of ISO 11608 standard entitled "Medical needle injection systems - Requirements and test methods", particularly the requirements of Part 2 entitled "Needles", i.e., all the requirements for such medical devices in ISO 11608-2.

[0032] Specifically, the purpose of this application is to design an active sheath sub-assembly for the needle injection tip that can be used in disposable sterile needle assemblies that meet the requirements defined by the ISO 11608 standard, particularly Part 2 of that standard entitled "Needles," i.e., ISO 11608-2. Thus, according to this application, a needle assembly with an active sheath sub-assembly for the needle injection tip can be used in conjunction with a pen syringe that meets the requirements defined by the ISO 11608 standard, particularly Part 1 of that standard entitled "Needle Injection Systems," i.e., ISO 11608-1.

[0033] The objective of this application is to make the sterile needle assembly with an active sheath sub-assembly for the needle tip conform to the requirements of ISO 11608. This standard allows for the use of the shortest possible syringe, thereby minimizing the so-called "dead space" volume—the volume of medication that should have been injected into the patient but could not be expelled from the syringe during injection and remains in the syringe afterward. If this so-called "dead space" in the syringe is too large and beyond the control of the sterile needle assembly designer, it can cause serious problems for the user, such as medication waste, inaccurate dosage, and disease transmission. In particular, data show that using disposable sterile needle assemblies and syringes with a smaller so-called "dead space" volume can significantly reduce the transmission of diseases from injecting drugs and individuals carrying the hepatitis C virus. This is because such medical devices significantly reduce the risk of disease transmission by minimizing the space within the syringe or between the syringe tip and the needle—spaces that can be entered by the blood of patients carrying infectious diseases.

[0034] Therefore, the purpose of this application is to design an active sheath subassembly for the injection end of a needle and a sterile needle assembly with a special structure that can minimize the volume of the so-called "dead space" in the needle tube.

[0035] The next objective of this application is to design a sterile needle assembly with an active sheath subassembly for the needle tip, which will ensure a low-cost yet reliable product with a simple structure, few components, and no springs or metal elastic elements, including pre-tensioned springs or metal elastic elements.

[0036] Another objective of this application is to design a sterile needle assembly with an active sheath sub-assembly for the needle injection tip. This sub-assembly ensures the secure covering of the needle injection tip and / or the non-injection tip before removing the sterile needle assembly from the pen syringe after injection. This eliminates the need for the user to handle the removal of the contaminated but unprotected needle assembly with the needle tip during this operation and subsequent disposal of the used needle assembly into an appropriate medical waste container, thereby minimizing or eliminating the possibility of needle pricks from the needle injection tip and / or the non-injection tip.

[0037] Another important objective of this application is to develop a sterile needle assembly with a specially structured active sheath sub-assembly for the needle injection end. This sub-assembly has a structure that reliably sheathes the needle injection end and / or the non-injection end, so that after use of the needle assembly and removal from the pen syringe, the needle container and external needle shield delivered to the user in the unit package do not need to be re-secured by external protective components. However, providing protection by external or separate protective components after use of the needle assembly and removal from the pen syringe is merely supplementary protection.

[0038] Another objective of this application is to design an active sheath subassembly for the injection end of a needle that operates reliably and is independent of the needle insertion technique or method used by medical personnel when performing subcutaneous or intramuscular injections.

[0039] Another objective of this application is to develop a sterile needle assembly having a specially structured active sheath sub-assembly for the needle injection end, the structure of which allows the user to reliably and irreversibly cover the needle injection end and / or the non-injection end of the needle by easily forcing the movement of the component having the needle injection end sheath or the component preferably the non-injection needle end sheath.

[0040] The purpose of this application is also to provide a disposable sterile needle assembly equipped with an active sheath sub-assembly for the needle injection end, which ensures that the needle injection end and / or the non-injection end can be covered not only after injection but also when not injected, and even when the injection end is not inserted into the patient and there is no contact between the non-injection end of the needle and the medicine contained in the primary packaging set in the pen syringe.

[0041] In addition, the purpose of this application is to provide a disposable sterile needle assembly with an active sheath sub-assembly for the needle injection end, wherein the injection end and / or non-injection end can be covered, locking the needle assembly in the covered state of the injection end and / or non-injection end, and, according to a specific variation of this application, if the user prepares the needle injection system for some reason but ultimately does not inject, it can be removed from the pen syringe without injection.

[0042] In other words, the purpose of this application is to provide a disposable sterile needle assembly with an active sheath sub-assembly for the needle injection end, wherein even if the needle assembly has not yet been injected into a patient for various reasons, the needle injection end and / or the non-injection end of the needle can be covered before the needle assembly is removed from the pen syringe.

[0043] In other words, the purpose of this application is to provide a disposable sterile needle assembly with an active sheath sub-assembly for the needle injection end, wherein the locking of the needle assembly in the sheathed state at the injection end and / or non-injection end is not activated by the action of injection or mimicking injection, that is, it is independent regardless of whether an injection has been performed.

[0044] A further object of this application is to provide a needle assembly equipped with an active sheath sub-assembly for the needle injection end, wherein the user can intuitively cover the injection end and / or non-injection end by pressing the needle assembly against a hard surface and applying a small force to the sheath of the injection end and / or the sheath of the non-injection end, depending on the user's preference, the injection situation, and a specific variant of this application.

[0045] Another object of this application is to provide a needle assembly equipped with an active sheath sub-assembly for the needle injection end, wherein dangerous movement of the user's hand or fingers toward any end of the injection end and / or non-injection end is eliminated in order to cover the injection end and / or non-injection end.

[0046] Another objective of this application is to develop a needle assembly with an active sheath sub-assembly for the needle tip injection end, comprising a small number of components and structural elements, and for the purpose of simplifying operation, all of these components and structural elements are held together in structural coupling before, during and after the use of the needle assembly.

[0047] Another objective of this application is to design a needle assembly having an active sheath sub-assembly for the needle injection tip, the structure of which ensures that at least the needle injection tip is covered without applying any additional components of the active sheath sub-assembly for the needle injection tip after the needle assembly is removed from the pen syringe, these additional components being separate from the components already included in the needle assembly.

[0048] The purpose of this application is also to develop a needle assembly with an active sheath sub-assembly for the needle injection end, the structure of which ensures that the active sheath is irreversibly blocked at the location covering the needle injection end, and / or that another sheath is irreversibly blocked at the location covering the non-injection needle end.

[0049] Another objective of this application is to design a needle assembly with an active sheath sub-assembly for the needle injection end, the structure of which ensures that even before the needle assembly is removed from the body of the pen syringe, and after any contact, even minimal contact, between the non-injection end and the drug contained in the primary packaging of the pen syringe, when the non-injection end is inserted into the container through a septum sealing the sterile drug in the container, the entire device is irreversibly blocked at the position covering the injection end and / or the non-injection end.

[0050] The primary objective of this application is to design a specially structured active sheath subassembly for the injection needle tip. This subassembly eliminates any pre-tensioned components—those that must be kept under tension, i.e., under load, from the moment the safety needle assembly is assembled until its activation. For proper operation of the needle assembly, these components must be kept under tension, i.e., under load, for example, as a pre-biased drive spring or pre-tensioning locking mechanism. Structures requiring such pre-tensioning of certain components are disadvantageous because they can lead to permanent deformation of these components during long-term storage or transportation of the needle assembly. This could result in inactivation of the injection or non-injection sheath, or blockage preventing activation of the injection or non-injection sheath after use, thus compromising protection of the contaminated needle tip. We are primarily discussing components made of plastic here.

[0051] Against this backdrop, another objective of this application is to design an active sheath subassembly for a needle injection tip whose structure eliminates the need for components made of metal, including metal pre-biasing components, particularly metal springs. This objective stems from the fact that metal components are undesirable for economic and disposal reasons, which is crucial for devices used in large-scale medical applications.

[0052] Another objective of this application is to provide a needle assembly with a simple structure, a small number of components and structural elements, no use of any springs (including metal or plastic springs), and a minimized overall product volume, thereby minimizing the costs of sterilization, packaging, transportation, and disposal, resulting in low production costs.

[0053] The purpose of this application is to provide a needle assembly that will ensure the coverage of the injection end and / or non-injection end after injection. That is, the needle assembly reliably covers the injection end or both needle ends without requiring the user to perform a series of specialized and precise operations when operating the needle assembly and the associated pen syringe.

[0054] Therefore, the main objective of this application is to design a needle assembly with an active sheath sub-assembly for the needle injection end, which is simple and intuitive to use and inexpensive, making it more affordable for both professional and home users.

[0055] Another objective of this application is to develop a needle assembly with an active sheath sub-assembly for the needle injection end, which will significantly reduce the risk of needlestick injury compared to known needle assembly solutions in the prior art, thereby reducing the risk of infection for the user.

[0056] The substance of this application According to this application, a disposable sterile needle assembly for use with a pen syringe includes a primary package filled with sterile medicine to form a needle injection system for medical use. It has a needle holder with a groove for attaching a needle assembly to a pen syringe for detachable connection; A needle tube fixedly embedded in a needle hub, the needle tube having an injection end with an injection tip for insertion into a patient to inject a drug; and a non-injection end with a non-injection tip for piercing a septum of the primary packaging to transfer the drug into the patient. The active sheath assembly for the upper needle injection end, mounted on the needle hub. in The needle hub and needle tube extend substantially around the longitudinal axis X of the needle assembly, which is determined by the longitudinal axis X of the needle tube. The active sheath subassembly for the needle tip extends substantially around the needle hub and is configured to actively cover the injection tip with the injection endpoint before the needle assembly is separated from the pen syringe. in The active sheath subassembly of the needle injection end includes a non-movable component that is immovably mounted on the needle hub and extends substantially along the longitudinal axis X of the needle assembly, a first movable component that is slidably mounted on the non-movable component along the longitudinal axis X of the needle assembly in the proximal direction, and a second movable component that is rotatably mounted on the non-movable component about a vertical axis Y relative to the longitudinal axis X of the needle assembly. The first movable component is movable between its initial position and its final position, in which it extends substantially along the longitudinal axis X of the needle assembly. The second movable component is movable between its initial position and its final position, in which it extends substantially perpendicular to the longitudinal axis X of the needle assembly; and in its final position, it extends substantially along the longitudinal axis X of the needle assembly. in The second movable component is fixedly coupled to the injection end sheath; and in the initial positions of the first and second movable components, the injection end with the injection tip is not covered, and in the final positions of the first and second movable components, the injection end with the injection tip is covered; and The fixed component, the first movable component, and the second movable component are configured to cooperate with each other, and the first movable component and the second movable component are movably engaged with each other, such that... Activation of the injection end sheath is achieved by forcing the second movable component to move, which in turn causes the first movable component to move, wherein each of the second and first movable components moves between its respective initial and final positions.

[0057] Preferably, in accordance with this application, in the needle sub-assembly and the active sheath sub-assembly of the needle injection end, the immovable component forms an mounting sleeve, and preferably, the first movable component forms a movable sleeve, the proximal end of which is preferably a flange.

[0058] Preferably, the needle assembly and the sheath sub-assembly each include: A first mounting device for slidably mounting a first movable component onto a non-movable component along the longitudinal axis X of the needle assembly in the proximal direction, wherein the first mounting device is preferably at least one longitudinal protrusion disposed on the non-movable component, more preferably two opposing longitudinal protrusions, and preferably at least one longitudinal groove disposed on the first movable component, more preferably two opposing longitudinal grooves, and A second mounting device for rotatably mounting a second movable component onto a non-movable component about a vertical axis Y relative to the longitudinal axis X of the needle assembly, wherein the second mounting device is preferably at least one pivot protrusion with a handle disposed on the non-movable component, more preferably, two opposing pivot protrusions with handles, and preferably, at least one shaped hole and at least one first tongue disposed on at least one arm of the second movable component, more preferably, two opposing shaped holes and two opposing first tongues on two opposing arms.

[0059] Preferably, the needle assembly and the sheath sub-assembly each include A first engagement device for engaging a first movable component with a non-movable component, wherein the first engagement device is preferably at least one pivot protrusion with a handle disposed on the non-movable component, more preferably two opposing pivot protrusions with handles, and preferably at least one longitudinal slit disposed on the first movable component, more preferably two opposing longitudinal slits, and A second engagement device for engaging a second movable component with a first movable component, wherein the second engagement device is preferably disposed on the distal surface of the proximal end of the first movable component, and preferably disposed on at least one first tongue, at least one bending surface, and at least one second tongue on at least one arm of the second movable component, more preferably on two opposing arms, comprising two opposing first tongues, two opposing bending surfaces, and two opposing second tongues. A third engagement device for engaging a second movable component with a non-movable component, wherein the third engagement device is preferably at least one pivot protrusion with a handle disposed on the non-movable component, more preferably two opposing pivot protrusions with handles, and preferably at least one shaped hole and at least one first tongue disposed on at least one arm of the second movable component, more preferably two opposing shaped holes and two opposing first tongues on two opposing arms.

[0060] Preferably, the needle assembly and the sheath sub-assembly each include: A protective device for protecting a second movable component from slipping off a non-movable component, wherein the protective device is preferably at least one retaining disc disposed on a handle of at least one pivot protrusion on the non-movable component, more preferably two opposing retaining discs disposed on two opposing handles of two opposing pivot protrusions, and preferably at least one shaped hole and at least one first tongue disposed on at least one arm of the second movable component, more preferably two opposing shaped holes and two opposing first tongues on two opposing arms.

[0061] Preferably, the needle assembly and the sheath sub-assembly each include: A first guide device for guiding a first movable component to slide along the longitudinal axis X of the needle assembly in the proximal direction on a non-movable component, wherein the first guide device is preferably at least one longitudinal protrusion disposed on the non-movable component, more preferably two opposing longitudinal protrusions, and preferably at least one longitudinal groove disposed on the first movable component, more preferably two opposing longitudinal grooves, and A second guide device for guiding the rotational movement of a second movable component relative to a non-movable component and on the first movable component about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, wherein the second guide device is preferably at least one pivot protrusion with a handle disposed on the non-movable component, more preferably two opposing pivot protrusions with two opposing handles, and preferably a distal surface of the proximal end disposed on the first movable component, and preferably at least one shaped hole, at least one first tongue, at least one bent push surface and at least one second tongue disposed on at least one arm of the second movable component, more preferably two opposing shaped holes, two opposing first tongues, two opposing bent push surfaces and two opposing second tongues on two opposing arms.

[0062] Preferably, the needle assembly and the sheath sub-assembly each include: A first retaining device for holding a first movable component and a second movable component in their initial positions relative to a non-movable component, wherein the first retaining device is preferably at least one pivoting protrusion with a handle disposed on the non-movable component, more preferably two opposing pivoting protrusions having two opposing handles, and preferably a distal surface of the proximal end and / or at least one pivoting protrusion disposed on the first movable component, more preferably a distal surface of the proximal end and / or two opposing pivoting protrusions, and preferably at least one first limiting surface and / or at least one shape hole and / or at least one first tongue and / or at least one bending push surface and / or at least one third limiting surface disposed on at least one arm of the second movable component, more preferably two opposing first limiting surfaces and / or two opposing shape holes and / or two opposing first tongues and / or two opposing bending push surfaces and / or two opposing third limiting surfaces on two opposing arms, and A second holding device for holding the first movable component (15) and the second movable component relative to the immovable component in their respective final positions, wherein the second holding device is preferably at least one pivot protrusion with a handle disposed on the immovable component, more preferably two opposing pivot protrusions with two opposing handles, and preferably a distal surface of the proximal end and / or at least one pivot protrusion disposed on the first movable component, more preferably a distal surface of the proximal end and / or two opposing pivot protrusions, and preferably at least one second limiting surface and at least one shape hole and / or at least one third limiting surface disposed on at least one arm of the second movable component, more preferably two opposing second limiting surfaces and two opposing shape holes and / or two opposing third limiting surfaces on two opposing arms.

[0063] Preferably, the needle assembly and the sheath sub-assembly each include A rotatable abutment device disposed on the second movable component is used to force the second movable component to rotate about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, and to displace the second movable component from its initial position to its final position, wherein the rotatable abutment device is preferably a rotatable abutment surface.

[0064] Preferably, the activation of the needle assembly and the sheath subassembly, including the injection end sheath, is achieved by moving the first movable component, causing the second movable component to move, between their respective initial and final positions.

[0065] Preferably, the needle assembly and the sheath sub-assembly each include: A sliding abutment device disposed on the first movable component (15) for forcing the first movable component to slide relative to the longitudinal axis X of the needle assembly in the proximal direction, and for displacing the first movable component from its initial position to its final position, wherein the sliding abutment device is preferably the distal surface of the proximal end.

[0066] Preferably, the needle assembly and the sheath sub-assembly each include: A lever device for rotating a second movable component about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, wherein the lever device preferably has at least one pivot protrusion disposed on the first movable component, more preferably two opposing pivot protrusions, and preferably has at least one third limiting surface disposed on at least one arm of the second movable component, more preferably two opposing third limiting surfaces on two opposing arms.

[0067] Preferably, the needle assembly and the sheath sub-assembly each have an irreversible blocking mechanism at the coverage position of the needle injection end, including an injection end sheath. A locking device for blocking a first movable component and a second movable component against each other in their final positions, wherein the locking device is preferably disposed on at least one blocking hole and a distal surface on the proximal end of the first movable component (15), more preferably two opposing blocking holes and distal surfaces, and preferably disposed on at least one first blocking surface and at least one second limiting surface on at least one arm of the second movable component, more preferably two opposing first blocking surfaces and two opposing second limiting surfaces on two opposing arms.

[0068] Preferably, in both the needle assembly and the sheath subassembly, the immovable component extends along the longitudinal axis X of the needle assembly to such a longitudinal dimension that, in the proximal direction, at least in its initial position and preferably in its final position, it protrudes beyond the needle hub and the first movable component, thereby forming a sheath for the non-injection end of the needle, at least before the needle assembly is attached to the pen syringe, and preferably after the activation of the injection end sheath and the coverage of the needle injection end.

[0069] Preferably, in the needle assembly and the sheath subassembly, the immovable component, the first movable component, and the second movable component are respectively configured in structure and size to each other such that the first movable component extends along the longitudinal axis X of the needle assembly to such a size that it protrudes beyond the needle hub and / or beyond the immovable component at least in its final position in the proximal direction, thereby forming a sheath of the non-injection end (5) of the needle at least after the injection end sheath is activated and the needle injection end is covered.

[0070] This application describes a disposable sterile needle assembly for use with a pen syringe, comprising a primary package filled with sterile pharmaceutical materials to form a needle injection system for medical use. A needle holder with a groove is provided for a connection device for detachably connecting the needle assembly to the pen syringe. A needle tube is fixedly embedded in a needle hub (1), and the needle tube has an injection end with an injection tip for insertion into the patient to inject a drug, and a non-injection end with a non-injection tip for piercing the diaphragm of the primary packaging to deliver the drug into the patient. Active needle tip sheath assembly mounted on the needle hub. in The needle hub and the needle tube extend substantially around the longitudinal axis X of the needle assembly, which is determined by the longitudinal axis X of the needle tube. The active sheath subassembly for the needle injection tip extends substantially around the needle hub and is configured to actively cover the injection tip with the injection endpoint prior to separation from the pen syringe needle assembly. in The active sheath subassembly for the needle injection end includes a non-movable component mounted on the needle hub and extending substantially along the longitudinal axis X of the needle assembly, and a first movable component and a second movable component are rotatably mounted on the non-movable component about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly. The first movable component and the second movable component are movable between an initial position and a final position, in which they extend substantially perpendicular to the longitudinal axis X of the needle assembly, and in the final position, they extend substantially along the longitudinal axis X of the needle assembly. in The second movable component is fixedly coupled to the injection end sheath; and in the initial positions of the first and second movable components, the injection end with the injection tip is not covered, while in the final positions of the first and second movable components, the injection end with the injection tip is covered; and The fixed component, the first movable component, and the second movable component are configured to cooperate with each other, and the first movable component and the second movable component are movably engaged with each other such that... Activation of the injection end sheath is achieved by forcing the movement of either the first or second movable component of the movable components to cause the movement of the other, each of the first and second movable components moving between its respective initial and final positions.

[0071] Preferably, in both the needle assembly and the sheath subassembly, the immovable component forms the mounting sleeve, and preferably, the first movable component forms a clamp that is configured as substantially cylindrical and incomplete, respectively.

[0072] Preferably, the needle assembly and the sheath sub-assembly each include: A first mounting device for rotatably mounting a first movable component onto a non-movable component about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, wherein the first mounting device is preferably at least one pivoting protrusion with a handle disposed on the non-movable component, more preferably two opposing pivoting protrusions with handles, and preferably at least one shaped hole and at least one gripping portion disposed on at least one arm of the first movable component, more preferably two opposing shaped holes and two opposing gripping portions disposed on at least one arm of the first movable component. A second mounting device for rotatably mounting a second movable component onto a non-movable component about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, wherein the second mounting device is preferably at least one pivot protrusion with a handle disposed on the non-movable component, more preferably two opposing pivot protrusions with handles, and preferably at least one shaped integral and at least one gripping portion disposed on at least one arm of the second movable component, more preferably two opposing shaped integrals and two gripping portions disposed on two opposing arms of the second movable component.

[0073] Preferably, the needle assembly and the sheath sub-assembly each include: A first engagement device for engaging a first movable component assembly with a non-movable component assembly, wherein the first engagement device is preferably at least one pivot protrusion with a handle disposed on the non-movable component assembly, more preferably two opposing pivot protrusions with handles, and preferably at least one shaped hole and at least one gripping portion disposed on at least one arm of the first movable component assembly, more preferably two opposing shaped holes and two opposing gripping portions disposed on two opposing arms of the first movable component assembly, and A second engagement device for engaging a second movable component with a first movable component, wherein the second engagement device is preferably at least one engaging joint disposed between at least one arm of the first movable component and at least one arm of the second movable component, more preferably two opposing engaging joints disposed between two opposing arms of the first movable component and two opposing arms of the second movable component, and A third engagement device for engaging the second movable component with the immovable component, wherein the third engagement device is preferably at least one pivot protrusion with the handle disposed on the immovable component, more preferably two opposing pivot protrusions with the handle, and preferably at least one shape hole and at least one gripping portion disposed on at least one arm of the second movable component, more preferably two opposing shape holes and two opposing gripping portions on two opposing arms of the second movable component.

[0074] Preferably, the needle assembly and the sheath sub-assembly each include A first protective device for preventing a first movable component from slipping off a non-movable component, wherein the first protective device is preferably at least one retaining disc disposed on a handle of at least one pivot protrusion on the non-movable component, more preferably two opposing retaining discs disposed on two opposing handles of two opposing pivot protrusions, and preferably at least one shaped hole and at least one gripping portion disposed on at least one arm of the first movable component, more preferably two opposing shaped holes and two opposing gripping portions disposed on two opposing arms of the first movable component, and A second protective device for preventing a second movable component from slipping off a non-movable component, wherein the second protective device is preferably at least one retaining disc disposed on a handle of at least one pivot protrusion on the non-movable component, more preferably two opposing retaining discs disposed on two opposing handles of two opposing pivot protrusions, and preferably at least one shaped hole and at least one gripping portion disposed on at least one arm of the second movable component, more preferably two opposing shaped holes and two opposing gripping portions disposed on two opposing arms of the second movable component.

[0075] Preferably, the needle assembly and the sheath sub-assembly each include A first guide device for guiding the rotational movement of a first movable component about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, wherein the first guide device is preferably a guide surface disposed on the non-movable component having at least one pivoting protrusion with a handle and one engaging protrusion, more preferably two opposing guide surfaces having two opposing pivoting protrusions and two opposing engaging protrusions with two opposing handles, and preferably at least one shaped hole and at least one gripping portion disposed on at least one arm of the first movable component, more preferably two opposing shaped holes and two opposing gripping portions and two opposing arms of the first movable component, and A second guide device for guiding the rotational movement of a second movable component relative to a non-movable component about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, wherein the second guide device is preferably at least one pivot protrusion with a handle disposed on the non-movable component, more preferably two opposing pivot protrusions with handles, and preferably at least one shaped hole and at least one gripping portion disposed on at least one arm of the second movable component, more preferably two opposing shaped holes and two opposing gripping portions disposed on two opposing arms of the second movable component.

[0076] Preferably, the needle assembly and the sheath sub-assembly each include A first holding device for holding a first movable component and a second movable component in their initial positions with respect to a non-movable component, wherein the first holding device is preferably disposed on the non-movable component and has at least one pivoting protrusion with a handle, at least one first limiting surface with at least one engaging protrusion, and at least one retaining protrusion, more preferably two opposing pivoting protrusions with two opposing handles, two opposing first limiting surfaces with two opposing engaging protrusions, and two opposing retaining protrusions; and preferably, at least one first blocking surface disposed on at least one arm of the first movable component, more preferably, two opposing first blocking surfaces on two opposing arms of the first movable component; and preferably, at least one arm on the second movable component, more preferably, two opposing arms. A second retaining device for holding a first movable component and a second movable component in their final positions relative to a non-movable component, wherein the second retaining device is preferably at least one second limiting surface disposed on the non-movable component having at least one pivoting protrusion with a handle and at least one engaging protrusion, more preferably a second limiting surface having two opposing pivoting protrusions and two opposing engaging protrusions with two opposing handles, and preferably at least one second blocking surface disposed on at least one arm of the first movable component, more preferably two opposing second blocking surfaces on two opposing arms of the first movable component.

[0077] Preferably, the needle assembly and the sheath sub-assembly each include A first rotatable abutment device disposed on a first movable component, the first rotatable abutment device being used to force the first movable component to rotate about a vertical axis Y perpendicular to the longitudinal axis of the needle assembly, and to move the first movable component from its initial position to its final position, wherein the first rotatable abutment device is preferably a rotatable abutment surface, and A second rotatable abutment is disposed on a second movable component, the second rotatable abutment being used to force the second movable component to rotate about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, and to move the second movable component from its initial position to its final position, wherein the second rotatable abutment is preferably a rotatable abutment surface.

[0078] Preferably, the needle assembly and the sheath sub-assembly each have an irreversible blocking mechanism for the injection end sheath (31) at the coverage position of the needle injection end, including... A locking device for locking a first movable component and a second movable component in their final positions relative to a non-movable component, wherein the locking device is preferably at least one second limiting surface of at least one engaging protrusion disposed on the non-movable component, more preferably two opposing second limiting surfaces of two opposing engaging protrusions, and preferably at least one second blocking surface disposed on at least one arm of the first movable component, more preferably two opposing second blocking surfaces disposed on two opposing arms of the second movable component.

[0079] Preferably, in both the needle assembly and the sheath subassembly, the immovable component extends along the longitudinal axis X of the needle assembly such that it protrudes beyond the needle hub in the proximal direction, thereby forming a sheath for the non-injection end of the needle before the needle assembly is attached to the needle assembly of the pen syringe and after the injection end sheath is activated and the needle injection end is covered.

[0080] Preferably, in the needle assembly and the sheath subassembly, the immovable component and the first movable component are respectively configured to each other in structure and size, such that the first movable component extends in its final position along the longitudinal axis X of the needle assembly to such a size that it protrudes beyond the needle hub and / or beyond the immovable component in the proximal direction, thereby forming a sheath for the non-injection end of the needle independently and / or together with the immovable component after the injection end sheath is activated and the needle injection end is covered.

[0081] Preferably, in the needle assembly and the sheath subassembly, the second movable component and the first movable component respectively constitute an integral structural member made of the same homogeneous material.

[0082] According to this application, a disposable sterile needle assembly for use with a pen syringe includes a primary package filled with sterile medicine to form a needle injection system for medical use. A needle hub with a groove, the groove being provided with an attachment device for detachably connecting a needle assembly to a pen syringe. A needle tube is fixedly embedded in a needle hub and has an injection end with an injection point and a non-injection end with a non-injection point. The injection end is used for insertion into the patient to administer an injection of a drug, and the non-injection end is used to puncture the diaphragm of the primary packaging to deliver the drug into the patient. The active sheath sub-assembly of the needle injection end is mounted on the needle hub (1). in The needle hub and the needle tube extend substantially around the longitudinal axis X of the needle assembly, which is determined by the longitudinal axis X of the needle tube. The active sheath subassembly for the needle injection tip extends substantially around the needle hub and is configured to activate the sheathing of the injection tip with the injection endpoint prior to disengaging the needle assembly from the pen syringe. in The active sheath subassembly for the needle tip injection end includes a non-movable component that is non-movably mounted on the needle hub and extends substantially along the longitudinal axis X of the needle assembly; a first movable component that is slidably mounted on the non-movable component in the proximal direction along the longitudinal axis X of the needle assembly; and a second movable component that is slidably mounted on the non-movable component in a direction perpendicular to the longitudinal axis X of the needle assembly and substantially toward the longitudinal axis X of the needle assembly. The first movable component moves between its initial position and its final position, in which it extends substantially along the longitudinal axis X of the needle assembly. The second movable component moves between its initial position and its final position, in which it extends substantially perpendicular to the longitudinal axis X of the needle assembly. in The second movable member (16) on the distal side of the needle assembly includes an injection end sheath; and The second movable component is rotatably coupled to the injection end sheath about a vertical axis Y1 perpendicular to the longitudinal axis X of the needle assembly, the vertical axis Y1 moving away from the longitudinal axis X of the needle assembly; and At the initial positions of the first movable component and the second movable component, the injection end with the injection endpoint is not covered, and at the final positions of the first movable component and the second movable component, the injection end with the injection endpoint is covered; and The immovable component, the first movable component, and the second movable component are configured to cooperate with each other, and the first movable component and the second movable component are movably engaged with each other, such that... The activation of the injection end sheath is achieved by forcing the second movable component to move, causing the first movable component to move between its respective initial and final positions.

[0083] Preferably, in the needle assembly and sheath subassembly, the immovable component forms an mounting sleeve, and more preferably, the first movable component forms a movable sleeve, the movable sleeve including at least one proximal protrusion at its proximal end, more preferably, including two opposing proximal protrusions.

[0084] Preferably, the needle assembly and the sheath sub-assembly each include A first mounting device for slidably mounting a first movable component onto a non-movable component along the longitudinal axis X of the needle assembly in the proximal direction, wherein the first mounting device is preferably at least one longitudinal protrusion disposed on the non-movable component, more preferably two opposing longitudinal protrusions, and preferably at least one longitudinal groove disposed on the first movable component, more preferably two opposing longitudinal grooves. A second mounting device for slidably mounting a second movable component on a non-movable component in a direction perpendicular to and substantially toward the longitudinal axis X of the needle assembly, wherein the second mounting device is preferably at least one pivot protrusion with a handle disposed on the non-movable component, more preferably two opposing pivot protrusions with handles, and preferably at least one connecting groove disposed on at least one arm of the second movable component, more preferably two opposing connecting grooves on two opposing arms.

[0085] Preferably, the needle assembly and the sheath sub-assembly each include A first engagement device for engaging a first movable component with a non-movable component, wherein the first engagement device preferably has at least one pivoting protrusion with a handle disposed on the non-movable component, more preferably two opposing pivoting protrusions with handles, and preferably has at least one longitudinal slit disposed on the first movable component, more preferably two opposing longitudinal slits. A second engagement device for engaging a second movable component with a first movable component, wherein the second engagement device is preferably at least one guide surface disposed on at least one proximal protrusion on the first movable component, more preferably two opposing guide surfaces of two opposing proximal protrusions, and preferably at least one fourth limiting surface and at least one push surface disposed on at least one arm of the second movable component, more preferably two opposing fourth limiting surfaces and two opposing push surfaces on two opposing arms. A third engagement device for engaging a second movable component with a non-movable component, wherein the third engagement device is preferably at least one pivot protrusion with a handle disposed on the non-movable component, more preferably two opposing pivot protrusions with handles, and preferably at least one coupling slot disposed on at least one arm of the second movable component, more preferably two opposing coupling grooves on two opposing arms, and A fourth engagement device for engaging the injection end sheath with a first movable component, wherein the fourth engagement device is preferably a distal surface disposed on the first movable component, and preferably at least one bending and pushing surface disposed on the injection end sheath, more preferably two opposing bending and pushing surfaces.

[0086] Preferably, the needle assembly and the sheath sub-assembly each include A protective device for preventing a second movable component from slipping off a non-movable component, wherein the protective device is preferably at least one retaining disc disposed on a handle of at least one pivot protrusion on the non-movable component, more preferably two opposing retaining discs on two opposing handles of two opposing pivot protrusions, and preferably at least one coupling slot disposed on at least one arm of the second movable component, more preferably a coupling slot on two opposing arms.

[0087] Preferably, the needle assembly and the sheath sub-assembly each include A first guide device for guiding the sliding movement of a first movable component on a non-movable component along the longitudinal axis of the needle assembly in the proximal direction, wherein the first guide device is preferably at least one longitudinal protrusion disposed on the non-movable component, more preferably two opposing longitudinal protrusions, and preferably at least one longitudinal groove disposed on the first movable component, more preferably two opposing longitudinal grooves, and A second guiding device for guiding sliding movement of a second movable component relative to a non-movable component and on a first movable component, the sliding movement being perpendicular to and substantially toward the longitudinal axis X of the needle assembly, wherein the second guiding device is preferably at least one pivoting protrusion with a handle disposed on the non-movable component, more preferably two opposing pivoting protrusions having two opposing handles, and preferably at least one guiding surface disposed on at least one proximal protrusion of the first movable component, more preferably two opposing guiding surfaces on two opposing proximal protrusions, and preferably at least one coupling slot and at least one fourth limiting surface and at least one push surface disposed on at least one arm of the second movable component, more preferably two opposing connecting grooves (56) and two opposing fourth limiting surfaces and two opposing push surfaces on two opposing arms, and A third guiding device for guiding the rotational movement of the injection end sheath on a first movable component about a vertical axis Y1 perpendicular to the longitudinal axis X of the needle assembly, wherein the vertical axis Y1 is away from the longitudinal axis X of the needle assembly. The third guiding device is preferably a distal surface disposed on the first movable component, and preferably at least one curved push surface disposed on the injection end sheath, more preferably two opposing curved push surfaces.

[0088] Preferably, the needle assembly and the sheath sub-assembly each include A first holding device for holding a first movable component and a second movable component in their initial positions with respect to a non-movable component, wherein the first holding device is preferably at least one pivoting protrusion with a handle disposed on the non-movable component, more preferably two opposing pivoting protrusions having two opposing handles, and preferably at least one guide surface disposed on at least one proximal protrusion on the first movable component, more preferably two opposing guide surfaces on two opposing proximal protrusions, and preferably at least one coupling slot and at least one fourth limiting surface disposed on at least one arm of the second movable component, more preferably two opposing coupling slots and two opposing fourth limiting surfaces on two opposing arms, and A second holding device for holding a first movable component and a second movable component in their final positions relative to a non-movable component, wherein the second holding device is preferably at least one pivoting protrusion with a handle disposed on the non-movable component, more preferably two opposing pivoting protrusions having two opposing handles, and preferably at least one guide surface disposed on at least one proximal protrusion disposed on the first movable component, more preferably two opposing guide surfaces on two opposing proximal protrusions, and preferably at least one coupling slot and at least one fifth limiting surface disposed on at least one arm of the second movable component, more preferably two opposing coupling slots and two opposing fifth limiting surfaces on two opposing arms.

[0089] Preferably, the needle assembly and the sheath sub-assembly each include A sliding abutment device disposed on a second movable component, the sliding abutment device being used to force the second movable component to slide perpendicular to the longitudinal axis X of the needle assembly and substantially toward the longitudinal axis X of the needle assembly, and to move the second movable component from its initial position to its final position, wherein the sliding abutment device is preferably a sliding abutment surface.

[0090] Preferably, in both the needle assembly and the sheath subassembly, an irreversible blocking mechanism for the injection end sheath is provided at the coverage position of the needle injection end, including... A locking device for blocking a first movable component and a second movable component from each other in their final positions, wherein the locking device is preferably at least one blocking surface and at least one guiding surface disposed on at least one proximal protrusion on the first movable component, more preferably two opposing blocking surfaces and two opposing guiding surfaces on two opposing proximal protrusions, and preferably at least one second blocking surface and at least one fifth limiting surface disposed on at least one arm of the second movable component, more preferably two opposing second blocking surfaces and two opposing fifth limiting surfaces on two opposing arms.

[0091] Preferably, in both the needle assembly and the sheath subassembly, the coupling slots of the second movable component are in a straight line configuration.

[0092] Preferably, in the needle assembly and the sheath subassembly, the immovable component extends along the longitudinal axis X of the needle assembly to such a longitudinal dimension that, at least in its initial position and preferably in its final position in the proximal direction, it protrudes beyond the needle hub and beyond the first movable component, thereby forming a sheath for the non-injection end of the needle, at least before the needle assembly is attached to the pen syringe and preferably after the injection sheath is activated and the needle injection end is covered.

[0093] Preferably, in the needle assembly and the sheath subassembly, the immovable component, the first movable component, and the second movable component are respectively configured in structure and size to each other, such that the first movable component extends along the longitudinal axis X of the needle assembly to such a size that it protrudes beyond the needle hub and / or the immovable component at least in its final position in the proximal direction, thereby forming a sheath for the non-injection end of the needle at least after the injection end sheath is activated and the needle injection end is covered.

[0094] According to this application, a disposable sterile needle assembly for use with a pen syringe includes a primary package filled with sterile medicine to form a needle injection system for medical use. A needle hub with a groove, the groove being provided with an attachment device for detachably connecting a needle assembly to a pen syringe. A needle is fixedly embedded in a needle hub and has an injection end with an injection point and a non-injection end with a non-injection point. The injection end is used for insertion into a patient to administer an injection of medication, and the non-injection end is used to puncture the septum of the primary packaging to transfer the medication into the patient. The active sheath sub-assembly for the needle injection end is mounted on the needle hub. in The needle hub and needle tube extend substantially around the longitudinal axis X of the needle assembly, which is defined by the longitudinal axis X of the needle tube. The active sheath subassembly for the needle injection tip extends substantially around the needle hub and is configured to activate the sheathing of the injection tip with the injection endpoint prior to disengaging the needle assembly from the pen syringe. in The active sheath subassembly for the needle tip injection end includes a non-movable component that is non-movably mounted on the needle hub and extends substantially along the longitudinal axis X of the needle assembly; a first movable component that is slidably mounted on the non-movable component in the proximal direction along the longitudinal axis X of the needle assembly; and a second movable component that is slidably mounted on the non-movable component in a direction perpendicular to the longitudinal axis X of the needle assembly and substantially toward the longitudinal axis X of the needle assembly. The first movable component moves between its initial position and its final position, in which it extends substantially along the longitudinal axis X of the needle assembly. The second movable component moves between its initial position and its final position, in which it extends substantially perpendicular to the longitudinal axis X of the needle assembly. in, The second movable component on the distal side of the needle assembly includes an injection end sheath; and The second movable component is fixedly coupled to the injection end sheath; and in the initial positions of the first and second movable components, the injection end with the injection tip is not covered, while in the final positions of the first and second movable components, the injection end with the injection tip is covered; and The immovable component, the first movable component, and the second movable component are configured to cooperate with each other, and the first movable component and the second movable component are movably engaged with each other, such that... The activation of the injection end cap (31) is achieved by forcing the second movable component to move, causing the first movable component to move between its respective initial and final positions.

[0095] Preferably, in both the needle assembly and the sheath subassembly, the immovable component forms an mounting sleeve, and more preferably, the first movable component forms a movable sleeve, the movable sleeve including at least one proximal protrusion at its proximal end, more preferably, including two opposing proximal protrusions.

[0096] Preferably, the needle assembly and the sheath sub-assembly each include a first mounting device for slidably mounting a first movable component onto a non-movable component along the longitudinal axis X of the needle assembly in the proximal direction, wherein the first mounting device is preferably at least one longitudinal protrusion disposed on the non-movable component (14), more preferably two opposing longitudinal protrusions, and preferably at least one longitudinal groove disposed on the first movable component, more preferably two opposing longitudinal grooves, and A second mounting device for slidably mounting a second movable component on a non-movable component in a direction perpendicular to and substantially toward the longitudinal axis X of the needle assembly, wherein the second mounting device is preferably at least one pivot protrusion with a handle disposed on the non-movable component, more preferably two opposing pivot protrusions with handles, and preferably at least one connecting groove disposed on at least one arm of the second movable component, more preferably two opposing connecting grooves on two opposing arms.

[0097] Preferably, the needle assembly and the sheath sub-assembly each include, A first engagement device for engaging a first movable component with a non-movable component, wherein the first engagement device preferably has at least one pivoting protrusion with a handle disposed on the non-movable component, more preferably two opposing pivoting protrusions with handles, and at least one longitudinal slit disposed on the first movable component, more preferably two opposing longitudinal slits. A second engagement device for engaging a second movable component with a first movable component, wherein the second engagement device is preferably at least one guide surface of at least one proximal protrusion on the first movable component, more preferably two opposing guide surfaces of two opposing proximal protrusions, and preferably at least one fourth limiting surface and at least one push surface disposed on at least one arm of the second movable component, more preferably two opposing fourth limiting surfaces and two opposing push surfaces on two opposing arms. A third engagement device for engaging a second movable component with a non-movable component, wherein the third engagement device is preferably at least one pivot protrusion with a handle disposed on the non-movable component, more preferably two opposing pivot protrusions with handles (19), and preferably at least one coupling slot disposed on at least one arm of the second movable component, more preferably two opposing coupling slots on two opposing arms.

[0098] Preferably, the needle assembly and the sheath sub-assembly each include, A protective device for preventing a second movable component from slipping off a non-movable component, wherein the protective device is preferably at least one retaining disc disposed on a handle of at least one pivot protrusion on the non-movable component, more preferably two opposing retaining discs on two opposing handles of two opposing pivot protrusions, and preferably at least one coupling slot disposed on at least one arm of the second movable component, more preferably a coupling slot on two opposing arms.

[0099] Preferably, the needle assembly and the sheath sub-assembly each include A first guide device for guiding the sliding movement of a first movable component on a non-movable component along the longitudinal axis X of the needle assembly in the proximal direction, wherein the first guide device is preferably at least one longitudinal protrusion disposed on the non-movable component, more preferably two opposing longitudinal protrusions, and preferably at least one longitudinal groove disposed on the first movable component, more preferably two opposing longitudinal grooves. A second guiding device for guiding sliding movement of a second movable component relative to a non-movable component and on a first movable component, the sliding movement being perpendicular to and substantially toward the longitudinal axis X of the needle assembly, wherein the second guiding device is preferably at least one pivoting protrusion with a handle disposed on the non-movable component, more preferably two opposing pivoting protrusions having two opposing handles, and preferably at least one guiding surface disposed on at least one proximal protrusion of the first movable component, more preferably two opposing guiding surfaces on two opposing proximal protrusions, and preferably at least one coupling slot and at least one fourth limiting surface and at least one push surface disposed on at least one arm of the second movable component, more preferably two opposing coupling slots and two opposing fourth limiting surfaces and two opposing push surfaces on two opposing arms.

[0100] Preferably, the needle assembly and the sheath sub-assembly each include, A first holding device for holding a first movable component and a second movable component in their initial positions with respect to a non-movable component, wherein the first holding device is preferably at least one pivoting protrusion with a handle disposed on the non-movable component, more preferably two opposing pivoting protrusions having two opposing handles, and preferably at least one guide surface disposed on at least one proximal protrusion on the first movable component, more preferably two opposing guide surfaces on two opposing proximal protrusions, and preferably at least one coupling slot and at least one fourth limiting surface disposed on at least one arm of the second movable component, more preferably two opposing coupling slots and two opposing fourth limiting surfaces on two opposing arms, and A second holding device for holding a first movable component and a second movable component in their final positions with respect to a non-movable component, wherein the second holding device is preferably at least one pivoting protrusion with a handle disposed on the non-movable component, more preferably two opposing pivoting protrusions with two opposing handles, and preferably at least one guide surface disposed on at least one proximal protrusion disposed on the first movable component, more preferably two opposing guide surfaces on two opposing proximal protrusions, and preferably at least one coupling slot and at least one fifth limiting surface disposed on at least one arm of the second movable component, more preferably two opposing coupling slots and two opposing fifth limiting surfaces on the two opposing arms.

[0101] Preferably, the needle assembly and the sheath sub-assembly each include, A sliding abutment device disposed on a second movable component, the sliding abutment device being used to force the second movable component to slide perpendicular to the longitudinal axis X of the needle assembly and substantially toward the longitudinal axis X of the needle assembly, and to move the second movable component from its initial position to its final position, wherein the sliding abutment device is preferably a sliding abutment surface.

[0102] Preferably, the needle assembly and the sheath sub-assembly each have an irreversible blocking mechanism for the injection end sheath (31) at the coverage position of the needle injection end, including... A locking device for blocking a first movable component and a second movable component from each other in their final positions, wherein the locking device is preferably at least one blocking surface and at least one guiding surface disposed on at least one proximal protrusion on the first movable component, more preferably two opposing blocking surfaces and two opposing guiding surfaces on two opposing proximal protrusions, and preferably at least one second blocking surface and at least one fifth limiting surface disposed on at least one arm of the second movable component, more preferably two opposing second blocking surfaces and two opposing fifth limiting surfaces on two opposing arms.

[0103] Preferably, in both the needle assembly and the sheath subassembly, the coupling slot of the second movable component is in the form of a dashed straight line.

[0104] Preferably, in the needle assembly and the sheath subassembly, the immovable component extends along the longitudinal axis X of the needle assembly to such a longitudinal dimension that, at least in its initial position and preferably in its final position in the proximal direction, it protrudes beyond the needle hub and beyond the first movable component, thereby forming a sheath for the non-injection end of the needle, at least before the needle assembly is attached to the pen syringe and preferably after the injection sheath is activated and the needle injection end is covered.

[0105] Preferably, in the needle assembly and the sheath subassembly, the immovable component, the first movable component, and the second movable component are respectively configured in structure and size to each other, such that the first movable component extends along the longitudinal axis X of the needle assembly to such a size that it protrudes beyond the needle hub and / or the immovable component at least in its final position in the proximal direction, thereby forming a sheath for the non-injection end of the needle at least after the injection end sheath is activated and the needle injection end is covered.

[0106] This application describes a disposable sterile needle assembly for use with a pen syringe, comprising a primary package filled with sterile pharmaceutical materials to form a needle injection system for medical use. A needle hub with a groove, the groove being provided with an attachment device for detachably connecting a needle assembly to a pen syringe. A needle is fixedly embedded in a needle hub and has an injection end with an injection point and a non-injection end with a non-injection point. The injection end is used for insertion into the patient to inject a drug, and the non-injection end is used to puncture the septum of the primary packaging to transfer the drug into the patient. The active sheath sub-assembly for the needle injection end is mounted on the needle hub. in The needle hub and needle tube extend substantially around the longitudinal axis X of the needle assembly, which is defined by the longitudinal axis X of the needle tube. The active sheath subassembly for the needle injection tip extends substantially around the needle hub and is configured to activate the sheathing of the injection tip with the injection endpoint prior to disengaging the needle assembly from the pen syringe. in The active sheath subassembly for the needle injection end includes a fixed component and a second movable component. The fixed component is fixedly mounted on the needle hub and extends substantially along the longitudinal axis X of the needle assembly. The second movable component is rotatably mounted on the fixed component about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly. The second movable component moves between its initial position and its final position, in which it extends substantially perpendicular to the longitudinal axis X of the needle assembly, and in the final position it extends substantially along the longitudinal axis X of the needle assembly. in The second movable component is fixedly coupled to the injection end sheath; and in the initial position of the second movable component, the injection end with the injection tip is not covered, and in the final position of the second movable component, the injection end with the injection tip is covered; and The fixed component and the second movable component are configured to cooperate with each other, such that Activation of the injection end sheath is achieved by forcing the second movable component to move between its initial and final positions.

[0107] Preferably, in both the needle assembly and the sheath subassembly, the non-movable components respectively constitute the mounting sleeve.

[0108] Preferably, the needle assembly and the sheath sub-assembly each include a mounting device for rotatably mounting the second movable component about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly onto the immovable component, wherein the mounting device is preferably at least one pivot protrusion with a handle disposed on the immovable component, more preferably two opposing pivot protrusions with handles, and preferably at least one shaped hole and at least one first tongue disposed on at least one arm of the second movable component, more preferably two opposing shaped holes and two opposing first tongues on two opposing arms.

[0109] Preferably, the needle assembly and the sheath assembly each include A engagement device for engaging a second movable component with a non-movable component, wherein the engagement device is preferably at least one pivoting protrusion with a handle and at least one second proximal protrusion with at least one guide surface disposed on the non-movable component, more preferably two opposing pivoting protrusions with handles and two opposing second proximal protrusions with two opposing guide surfaces, and preferably at least one first tongue and at least one shaped hole disposed on at least one arm of the second movable component, more preferably two opposing first tongues and two opposing shaped holes on two opposing arms.

[0110] Preferably, the needle assembly and the sheath sub-assembly each include A protective device for preventing a second movable component from slipping off a non-movable component, wherein the protective device is preferably at least one retaining disc disposed on a handle of at least one pivot protrusion on the non-movable component, more preferably two opposing retaining discs disposed on two opposing handles of two opposing pivot protrusions, and preferably at least one shaped hole and at least one first tongue disposed on at least one arm of the second movable component, more preferably two opposing shaped holes and two opposing first tongues on two opposing arms.

[0111] Preferably, the needle assembly and the sheath sub-assembly each include A guiding device for guiding the rotational movement of a second movable component relative to a non-movable component about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, wherein the guiding device is preferably at least one pivoting protrusion with a handle and at least one second proximal protrusion with at least one guide surface disposed on the non-movable component, more preferably two opposing pivoting protrusions with handles and two opposing second proximal protrusions with two opposing guide surfaces, and preferably at least one shaped hole, at least one first tongue, at least one bending push surface and at least one second tongue disposed on at least one arm of the second movable component, more preferably two opposing shaped holes, two opposing first tongues, two opposing bending push surfaces and two opposing second tongues disposed on two opposing arms.

[0112] Preferably, the needle assembly and the sheath sub-assembly each include A first retaining device for holding the second movable component in its initial position relative to the immovable component, wherein the first retaining device is preferably at least one pivoting protrusion with a handle and / or at least one first proximal protrusion and / or at least one second proximal protrusion with a guide surface disposed on the immovable component, more preferably two opposing pivoting protrusions with handles, and / or two opposing first proximal protrusions and / or two opposing second proximal protrusions with two opposing guide surfaces, and preferably at least one shape hole and / or at least one first limiting surface and / or at least one first tongue and / or at least one bending push surface disposed on at least one arm of the second movable component, more preferably two opposing shape holes and / or two opposing first limiting surfaces and / or two opposing first tongues and / or two opposing bending push surfaces on two opposing arms, and A second holding device for holding a second movable component in its initial position relative to the immovable component, wherein the second holding device is preferably at least one pivoting protrusion with a handle and at least one second proximal protrusion with at least one guide surface disposed on the immovable component, more preferably two pivoting protrusions with two opposing handles and two opposing second proximal protrusions with two opposing guide surfaces, and preferably at least one second limiting surface and at least one shape hole disposed on at least one arm of the second movable component, more preferably two opposing second limiting surfaces and two opposing shape holes on the two opposing arms.

[0113] Preferably, the needle assembly and the sheath sub-assembly each include A rotatable abutment device disposed on a second movable component, the rotatable abutment device being used to force the second movable component to rotate about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, and to displace the second movable component from its initial position to its final position, wherein the rotatable abutment device is preferably a rotatable abutment surface.

[0114] Preferably, in both the needle assembly and the sheath subassembly, an irreversible blocking mechanism for the injection end sheath is provided at the coverage position of the needle injection end (3) with the injection endpoint, including... A locking device for blocking a non-movable component and a second movable component from each other in their final positions, wherein the locking device is preferably at least one second proximal protrusion having at least one guide surface and at least one blocking surface disposed on the non-movable component, more preferably two opposing second proximal protrusions having two opposing guide surfaces and two opposing blocking surfaces, and preferably at least one first blocking surface and at least one second limiting surface disposed on at least one arm of the second movable component, more preferably two opposing first blocking surfaces and two opposing second limiting surfaces on two opposing arms.

[0115] Preferably, in both the needle assembly and the sheath subassembly, the immovable component extends along the longitudinal axis X of the needle assembly to such a longitudinal dimension that it protrudes beyond the needle hub in the proximal direction, thereby forming a sheath for the non-injection end of the needle before the needle assembly is attached to the pen syringe and after the activation of the injection sheath and the covering of the needle injection end (3).

[0116] Preferably, in both the needle assembly and the sheath subassembly, the immovable component, together with the needle hub, forms an integral structure made of the same homogeneous material.

[0117] Preferably, the needle assembly and the sheath sub-assembly, respectively, wherein the second movable component portion together with the injection end sheath constitute an integral structure made of the same homogeneous material.

[0118] Preferably, both the needle assembly and the sheath subassembly include a supplementary sheath for the non-injection end of the needle, the supplementary sheath being configured such that, after activation of the injection sheath and after disassembly of the needle assembly from the pen syringe, it is adapted to mate with the needle assembly on the proximal side of the needle assembly, wherein the supplementary sheath for the non-injection end of the needle is permanently or detachably coupled to the sheath subassembly and is preferably a cork, or a separate part of the needle assembly device not connected to the sheath subassembly, and preferably the dome of the needle container of the needle assembly.

[0119] According to this application, a component for an active sheath assembly for a needle injection tip and a disposable sterile needle assembly includes technical features of a non-movable component.

[0120] According to this application, a component for an active sheath subassembly for a needle injection tip and a disposable sterile needle assembly includes the technical features of a first movable component.

[0121] According to this application, a component for an active sheath assembly for a needle injection tip and a disposable sterile needle assembly includes a second movable component.

[0122] According to this application, a unit package includes a disposable sterile needle assembly with an active needle tip sheath subassembly. According to this application, it is protected by at least one of two components, the two components including an outer needle shield that seals the needle tip and a needle container that houses the disposable sterile needle assembly with the active needle tip sheath subassembly, and is protected by a seal that tightly seals the sterile needle assembly with the sheath subassembly.

[0123] One user package of this application includes a set of unit packages, and according to this application, preferably includes a set of pen syringes having primary packages filled with sterile medicines, the pen syringes being configured to work together to safely inject the medicines into a patient, including reducing the risk of infection by pathogens transmitted through the patient's bloodstream.

[0124] This application discloses a needle injection system for medical use, comprising a disposable sterile needle assembly with an active sheath subassembly for the needle tip, and a pen syringe comprising a primary package containing sterile medicine, configured to work together to inject the medicine into a patient in a safe manner for the user, including reducing the risk of infection by pathogens transmitted through the patient's bloodstream.

[0125] Advantages of this application The advantage of the active sheath sub-assembly for the needle injection end of this application is that it can be used in disposable sterile needle assemblies without any substantial structural or dimensional modifications. This assembly meets the requirements defined by the ISO 11608 standard, particularly Part 2 of which is titled "Needles," i.e., ISO 11608-2. Therefore, this needle assembly can be used together with the active sheath sub-assembly for the non-injection end of this application in pen syringes that meet the requirements defined by the ISO 11608 standard, particularly Part 1 of which is titled "Needle Injection Systems," i.e., ISO 11608-1.

[0126] In this paper, a key advantage of the active sheath subassembly for the needle injection end according to this application is that its structure enables the use of very short needle tubes, thereby minimizing the so-called "dead space" and eliminating all the disadvantages of known sheath subassemblies that include longer needle tubes.

[0127] The active needle tip sheath sub-assembly of this application and the sterile needle assembly including the sheath assembly also do not have the aforementioned disadvantages present in known disposable needle assemblies. The advantage of the needle assembly with the active needle tip sheath sub-assembly of this application is that, in order to cover the needle tip and keep the sheath in place, the user does not need to make any dangerous movements with their hands or fingers in either direction of the injection tip and / or non-injection tip.

[0128] According to this application, in a needle assembly with an active sheath sub-assembly for the needle injection end, the need for the user to operate the needle assembly with a contaminated but unprotected needle end is eliminated, and the possibility of being pricked by the needle injection end and / or the non-injection end of the needle is thus minimized or eliminated.

[0129] Furthermore, the locking of the needle assembly in its covered state at the injection end and / or non-injection end is not activated by injection or the action of simulating injection, and therefore it is unrelated to injection regardless of whether an injection has been performed.

[0130] The sheath subassembly according to this application allows the needle assembly to be secured and safely removed from the pen syringe without injection.

[0131] In the needle assembly with an active needle tip sheath sub-assembly according to this application, the irreversible blocking of the needle tip sheath and / or the needle non-injection end sheath, as well as the sheath of the needle tip or the shields of both needle ends, is still performed by the user before removing the needle assembly from the pen syringe. After the needle assembly is installed on the pen syringe, and after removing the external protective components of the unit package, i.e., the seals, the needle container of the needle assembly, and / or the external needle shield of the needle tip, i.e., after the needle injection system is ready for injection but before removing the needle assembly from the pen syringe, even if no injection is performed for some reason, it is important to ensure the possibility of irreversible blocking of the needle assembly with the injection and / or non-injection ends covered. This is because all commercially available needle assemblies require insertion or simulated insertion actions, such as inserting into a sponge or activating the injection end shield by moving a finger towards the end, in order to activate the shielding and blockage of one or more ends, which is not a safe action.

[0132] According to this application, a significant advantage of the needle assembly with an active needle tip sheath sub-assembly is the improved ergonomics of operation, which is important for both medical personnel and individual users. Due to the construction and shape of the needle tip sheath, the user's grip is improved, preventing finger slippage. Therefore, on the one hand, screwing the entire unit package with the needle assembly onto the pen syringe is easier, and on the other hand, after locking the needle tip sheath and / or the non-injection end sheath in the sheath position, unscrewing the needle assembly from the pen syringe is much easier than with known needle assemblies.

[0133] Furthermore, according to this application, the needle assembly with an active sheath sub-assembly for the needle injection end is not only simple to manage but also intuitive.

[0134] Depending on each specific user's preference, but also on the circumstances under which the injection is performed, and depending on a specific variant of this application, in order to achieve coverage of the injection end and / or the non-injection end, the user simply presses the needle assembly against a hard surface and applies a small force to the second movable component including the injection end sheath or preferably the first movable component including the non-injection end sheath.

[0135] In the needle assembly with an active needle tip sheath subassembly according to this application, the external protective component for the non-injection end of the needle and the entire disposable sterile needle assembly, namely the cork or dome of the needle container, is designed for the groove in the needle hub, constituting an additional protective component and providing additional protection for the non-injection end of the needle after use and removal from the pen syringe. The protection function of the cork or dome of the needle container for the non-injection end of the needle in the needle hub groove is essentially complementary, because the design of the active needle tip sheath subassembly and the disposable sterile needle assembly according to this application ensures secure coverage of both the injection and non-injection ends of the needle, even when used alone without these additional external protective components, depending on the embodiment of each variant of this application selected according to the user's choice.

[0136] A significant advantage of the needle assembly with active sheath subassembly for the needle injection end of this application is that it has a simple structure, few parts, simple technology, does not use any springs including metal or plastic springs, and has pre-biasing, which results in low costs for its manufacture, sterilization, packaging, transportation and use.

[0137] The needle assembly and active sheath subassembly of the needle injection end of this application are reliable in function and intuitive and easy to operate, fully complying with the requirements of ISO 11608 standard. The product has low cost throughout its entire life cycle, from the production of its various components to preparation and delivery to the user, and finally to use under necessary supervision. All of these factors make this medical product one of the basic medical products for mass medical applications. In the severe economic reality following the coronavirus pandemic, it has received high attention from healthcare financial officers and home users.

[0138] Further advantages and features of this application will be described in or become apparent from the following detailed description of preferred embodiments of this application. Attached Figure Description

[0139] The embodiments of this application will be further described below with reference to the accompanying drawings, wherein: This application covers five variations of the active sheath assembly for needle tip injection, as well as preferred and non-limiting embodiments, its components and structural elements, and disposable sterile needle assemblies including the active sheath subassembly for needle tip injection and needle injection systems for medical use, such as... FIG. 1 As shown in -43, Figures 1-2, 3, 4A-4B, 5A-5B, 6A-6C, and 7-29 illustrate and substantially relate to a first variant of the active sheath subassembly for the needle injection end according to this application, wherein, like FIG. 3 The needle hub 1 shown is also basically applied to the second, third, fourth and fifth variations of the sheath subassembly according to this application, and like FIG. 4A The embodiment of the non-removable component 14 in the form of a mounting sleeve 14 shown in 4B is also applied to the third and fourth variations of the sheath subassembly according to this application. FIG. 3 Figures 30-31 show and relate to a second variation of the active sheath subassembly for the needle injection end according to this application. FIG. 3 , FIG. 4A-4B , FIG. 5C-5D , FIG. 6D-6E Figures 32-34 illustrate and relate to a third variation of the active sheath subassembly for the needle injection end according to this application, and FIG. 3 , FIG. 4A-4B , FIG. 5C-5D , FIG. 6F-6G Figures 35-37 illustrate and relate to a fourth variation of the active sheath subassembly for the needle injection end according to this application. FIG. 3 , FIG. 6A-6CFigures 38-43 illustrate and relate to a fifth variation of the active sheath subassembly for the needle injection tip according to this application. in Combination FIG. 1-2 , FIG. 3 , FIG. 4A-4B , FIG. 5A-5B , FIG. 6A-6C Figure 7-29 shows, and primarily relates to, a first variant of the active sheath subassembly for the needle injection end according to this application. FIG. 1 This illustration shows a longitudinal cross-sectional view of a unit package 13 of a disposable sterile needle assembly with a sterile seal and an active sheath sub-assembly for the needle tip, according to the present application. FIG. 2 It shows FIG. 1 An exploded perspective view of unit package 13 and its constituent parts. FIG. 3 A longitudinal cross-sectional view of a needle hub 1 with a needle tube 2 is shown, which together constitute a disposable sterile needle assembly according to this application and meet the requirements defined in ISO 11608. FIG. 4A A longitudinal cross-sectional view of the immovable component 14 is shown. In this preferred embodiment, the immovable component constitutes the mounting sleeve 14 and is included within... FIG. 1-2 In the active sheath assembly of the needle injection tip, FIG. 4B It shows FIG. 4A A perspective view of the mounting sleeve 14. in FIG. 4A-4B The preferred embodiment of the immovable component 14 shown can also be applied to the third and fourth variations of the active sheath subassembly at the needle injection end, as shown in Figures 32-34 and 35-37, respectively. FIG. 5A A perspective view of a first movable component 15 is shown, which in this preferred embodiment constitutes the movable sleeve 15 and is included within... FIG. 1-2 In the first variant of the active sheath subassembly for the needle injection end FIG. 5B It shows FIG. 5A Longitudinal cross-sectional view of the movable sleeve 15 in the middle. FIG. 5C and FIG. 5D A perspective view of a first movable component 15 is shown, which in this preferred embodiment constitutes a movable sleeve 15 and is included in the third and fourth variations of the active needle injection tip sheath subassembly shown in Figures 32-34 and 35-37, respectively. FIG. 6A It shows that it includes, for example FIG. 1-2Figures 7-29 and 38-43 show perspective views of the second movable component 16 in the first and fifth variations of the active sheath subassembly for the needle injection end, respectively. FIG. 6B A perspective view of a second movable component 16 is shown in another preferred embodiment, which is applied to, for example... FIG. 1-2 In the first and fifth variations of the active sheath subassembly for the needle injection end shown in Figures 7-29 and 38-43, FIG. 6C It shows FIG. 6B A side view of the second movable component 16 in the preferred embodiment shown. FIG. 6D and FIG. 6E A perspective view of the second movable component 16 included in the third variant of the active sheath subassembly for the needle injection tip shown in Figures 32-34 is presented. FIG. 6F and FIG. 6G A perspective view of the second movable component 16 included in the fourth variant of the active sheath subassembly for the needle injection tip shown in Figures 35-37 is presented. FIG. 7A A perspective view of a disposable sterile needle assembly with an active needle tip sheath sub-assembly in a preferred embodiment is shown, substantially as follows: FIG. 1-2 As shown, however, an additional sheath in the form of a cork 41 is provided for the non-injection end 5, for a groove formed by an extension groove 7 of the needle hub 1, the groove including the non-injection end 5 of the needle, wherein the cork 41 is fixedly connected to the movable sleeve 15 of the active sheath subassembly of the needle injection end. FIG. 7B It shows FIG. 7A The view shows a perspective view of the needle assembly after the cork 41 mates with the extended groove 7 of the needle interface 1, indicating that the non-injection end 5 of the needle is completely covered. FIG. 8A A perspective view of a disposable sterile needle assembly according to a preferred embodiment is shown, the assembly having an active sheath sub-assembly for the needle injection end, substantially as follows: FIG. 1-2 As shown, an additional sheath is provided for the non-injection end 5, which is the dome 17 of the needle container 11 of the needle assembly. FIG. 8B It shows FIG. 8A A perspective view of the needle assembly, wherein the dome 17 of the needle container 11 of the needle assembly matches the extended groove 7 of the needle hub 1, and this view shows that the non-injection end 5 of the needle is completely covered. Figure 9-11 shows a view of a disposable sterile needle assembly, which in its preferred embodiment has an active sheath sub-assembly for the needle injection end, substantially as follows: FIG. 1-2As shown, however, in another preferred embodiment, a second movable component 16 is provided, along with a long movable sleeve 15. When covering the injection end 3, the long movable sleeve 15 travels a long distance along the longitudinal axis X of the needle assembly in the proximal direction between its initial and final positions, wherein the needle assembly is mounted on the pen syringe 42. FIG. 9A-9E A perspective view, a front view, a cross-sectional view along the plane of symmetry Z, a rear view along a plane defined by the longitudinal axis X and a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, and a side view of the needle assembly are shown, wherein the second movable component 16 and the movable sleeve 15 are in their initial positions. FIG. 10A-10E A perspective view, a front view, a cross-sectional view along the plane of symmetry Z, a rear view along a plane defined by the longitudinal axis X and a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, and a side view of the needle assembly are shown, wherein the second movable component 16 and the movable sleeve 15 are in intermediate and final positions between their initial positions. FIG. 11A-11E A perspective view, a front view, a cross-sectional view along the plane of symmetry Z, a rear view along a plane defined by the longitudinal axis X and a perpendicular axis Y perpendicular to the longitudinal axis X of the needle assembly, and a side view of the needle assembly are shown, wherein the second movable component 16 and the movable sleeve 15 are in their final positions. Figures 12-14 show a perspective view of a disposable sterile needle assembly having an active needle tip sheath sub-assembly in a preferred embodiment, which is substantially as follows: FIG. 1-2 As shown, but in another preferred embodiment, a second movable component 16 is provided, and has a long movable sleeve 15 that makes a short stroke along the longitudinal axis X of the needle assembly in the proximal direction between its initial and final positions during the coverage of the injection end 3, wherein the needle assembly is mounted on the pen syringe 42, and FIG. 12A-12E The diagram shows a perspective view, a front view, a cross-sectional view along the plane of symmetry Z of the needle assembly, a rear view along a plane defined by the longitudinal axis X and a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, and a side view of the needle assembly, wherein the second movable component 16 and the movable sleeve 15 are in their initial positions. FIG. 13A-13EA perspective view, a front view, a cross-sectional view along the plane of symmetry Z, a rear view along a plane defined by the longitudinal axis X and a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, and a side view of the needle assembly are shown, wherein the second movable component 16 and the movable sleeve 15 are in an intermediate position between their initial and final positions. FIG. 14A-14E A perspective view, a front view, a cross-sectional view along the plane of symmetry Z, a rear view along a plane defined by the longitudinal axis X and a perpendicular axis Y perpendicular to the longitudinal axis X of the needle assembly, and a side view of the needle assembly are shown, wherein the second movable component 16 and the movable sleeve 15 are in their final positions. Figures 15-17 show views of a disposable sterile needle assembly in a preferred embodiment, which includes an active sheath sub-assembly for the needle injection tip, substantially as follows: FIG. 1-2 As shown, but with a very long mounting sleeve 14, in which the needle assembly is mounted on the pen syringe 42, and FIG. 15A-15B A cross-sectional view along the plane of symmetry Z of the needle assembly and a side view of the needle assembly are shown, with the second movable component 16 and the movable sleeve 15 in their initial positions. FIG. 16A-16B A cross-sectional view along the plane of symmetry Z of the needle assembly and a side view of the needle assembly are shown, respectively, wherein the second movable component 16 and the movable sleeve 15 are in an intermediate position between their initial and final positions, and FIG. 17A-17B A cross-sectional view along the plane of symmetry Z of the needle assembly and a side view of the needle assembly are shown, with the second movable component 16 and the movable sleeve 15 in their final positions, while FIG. 18A-18E A perspective view of a disposable sterile needle assembly with an active needle injection tip sheath subassembly according to another preferred embodiment is shown, wherein the movable sleeve 15 is provided with a pivoting protrusion 29 configured to rotate a second movable component 16 about a vertical axis Y, which is perpendicular to the longitudinal axis X of the needle assembly and faces toward the needle injection tip 3, and to force the movable sleeve 15 to move proximally relative to the longitudinal axis X of the needle assembly, wherein FIG. 18A-18E The diagram shows a perspective view, a rear view, a rear view, a side view, and a cross-sectional view along the plane defined by the longitudinal axis X of the needle assembly and the vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, respectively. FIG. 19-21A needle injection system for medical use according to a preferred embodiment of this application is shown, the system having a disposable sterile needle assembly and an active needle injection end sheath subassembly, mainly as shown in Figures 9-11, and demonstrating how the needle injection end sheath 31 is activated by forcing a second movable component 16 to rotate relative to an axis Y, which is perpendicular to the longitudinal axis X of the needle assembly and toward the needle injection end 3, wherein... FIG. 22-24 A needle injection system for medical use according to a preferred embodiment of this application is shown, the system having a disposable sterile needle assembly and an active sheath subassembly for the needle injection end, such as... FIG. 18A-18E As shown, and demonstrated, how to activate the needle injection end sheath 31 by forcing the movable sleeve 15 to slide relative to the longitudinal axis X and the proximal direction of the needle assembly. FIG. 25-29 This illustration shows a medical needle injection system according to a preferred embodiment of the present application, comprising a disposable sterile needle assembly and an active needle tip sheath subassembly. Figures 9-11 are essentially cross-sectional views along the Z-plane of symmetry of the needle assembly, and depict the subsequent operating states and stages of the needle injection system. FIG. 25 The illustration shows unit package 13, with the seal 12 of the unit package previously removed, and pen syringe 42 with primary package 45, with the protective cap of the pen syringe 42 previously removed, in preparation for mounting the needle assembly onto the pen syringe 42 to form a needle injection system. FIG. 26 The diagram illustrates a needle injection system prior to the removal of protective components included in the unit package 13, namely the needle container 11 of the needle assembly and the outer needle shield 10 of the needle injection end 3. Figure 27 shows the needle injection system in a state of readiness to perform an injection, or in the process of performing an injection.

[0140] FIG. 28 This shows the state of the needle injection system after the needle tip 3 is covered. FIG. 29 The needle injection system is shown in the state after the needle assembly has been removed from the pen syringe 42; and FIG. 3 Related to Figures 30-31 FIG. 3 Figures 30-31 illustrate and relate to a second variant of the active sheath subassembly for the needle injection end according to this application. FIG. 3 As shown above, FIG. 30A-30DThe diagram shows a side view, a rear view, and a perspective view of the distal side of the needle assembly with the sheath sub-assembly; a cross-sectional view along the plane of symmetry Z of the needle assembly; a side view; and a perspective view of the proximal side, with the second movable component 16 and the first movable component 15 in their initial positions. FIG. 31A-31D The following are shown: a side view, a rear view, and a distal perspective view of the needle assembly having the sheath sub-assembly; a cross-sectional view along the plane of symmetry Z of the needle assembly; a side view; and a side view, a rear view, and a proximal perspective view, wherein the second movable component 16 and the first movable component 15 are in their final positions. and FIG. 3 , FIG. 4A-4B , FIG. 5C-5D , FIG. 6D-6E Related to Figures 32-34, these figures illustrate and relate to a third variation of the active sheath subassembly for the needle injection tip according to this application. Figures 3, 4A-4B, 5C-5D, and 6D-6E are as described above. FIG. 32A-32C A perspective view of the needle assembly, a cross-sectional view along the plane of symmetry Z, and a side view of the needle assembly with the sheath sub-assembly are shown, wherein the second movable component 16 and the movable sleeve 15 are in their initial positions. FIG. 33A-33C A perspective view, a cross-sectional view along the plane of symmetry Z, and a side view of the needle assembly with the sheath sub-assembly are shown, wherein the second movable component 16 and the movable sleeve 15 are in an intermediate position between their initial and final positions, and FIG. 34A-34C A perspective view of the needle assembly, a cross-sectional view along the plane of symmetry Z, and a side view of the needle assembly with the sheath sub-assembly are shown, wherein the second movable component 16 and the movable sleeve 15 are in their final positions; and and FIG. 3 , FIG. 4A-4B , FIG. 5C-5D , FIG. 6F-6G Related to Figures 35-37, these figures illustrate and relate to a fourth variation of the active sheath subassembly for the needle injection tip according to this application. FIG. 3 , FIG. 4A-4B , FIG. 5C-5D , FIG. 6F-6G As mentioned above, FIG. 35A-35C A perspective view of the needle assembly, a cross-sectional view along the plane of symmetry Z, and a side view of the needle assembly with the sheath sub-assembly are shown, wherein the second movable component 16 and the movable sleeve 15 are in their initial positions. FIG. 36A-36C A perspective view, a cross-sectional view along the plane of symmetry Z, and a side view of the needle assembly with the sheath sub-assembly are shown, wherein the second movable component 16 and the movable sleeve 15 are in an intermediate position between their initial and final positions, and FIG. 37A-37C A perspective view of the needle assembly, a cross-sectional view along the plane of symmetry Z, and a side view of the needle assembly with the sheath sub-assembly are shown, wherein the second movable component 16 and the movable sleeve 15 are in their final positions; and and FIG. 3 Related to Figures 38-43, FIG. 3 Figures 38-43 illustrate and relate to a fifth variation of the active sheath subassembly for the needle injection end according to this application. FIG. 3 As shown above, FIG. 38A A perspective view of the rear, side, and distal side of a needle assembly with a sheath sub-assembly is shown, wherein the second movable component 16 is mounted on the immovable component 14 and is in its initial position. FIG. 38B A perspective view of the rear, side, and distal side of the needle assembly with the sheath sub-assembly is shown, as follows: FIG. 38A As shown, the second movable component 16 is mounted on the immovable component 14 and is in its final position. FIG. 39A A perspective view of the rear and distal sides of the needle assembly and sheath subassembly is shown. This view represents a preferred embodiment of the fifth variant, which differs from... FIG. 38A-38B In the embodiment shown, the immovable component 14 and the pin holder 1 together form an integral structure made of the same homogeneous material. The second movable component 16 is not shown in this view. FIG. 39B A perspective view of the rear, side, and distal sides of a needle assembly with a sheath sub-assembly is shown. FIG. 39A The preferred embodiment of the fifth variant shown in the view illustrates the second movable component 16 in its initial position. FIG. 40A and FIG. 40B A perspective view of the needle assembly with a sheath subassembly is shown. FIG. 40A The preferred embodiment of the fifth variant shown.

[0141] 38A-38B, wherein the second movable component 16 is mounted on the immovable component 14 and is in its initial position. FIG. 40C It shows FIG. 40Aand FIG. 40B A side view of the needle assembly with the sheath sub-assembly, wherein the second movable component 16 is in its initial position. FIG. 41A and FIG. 41B It shows FIG. 40A-40C A perspective view of the needle assembly with a sheath sub-assembly in a preferred embodiment of the fifth variant, wherein the second movable component 16 is in its final position. FIG. 41C It shows FIG. 41A and FIG. 41B A side view of the needle assembly with the sheath sub-assembly, wherein the second movable component 16 is in its final position. Figures 42A and 42B show perspective views of a needle assembly with a sheath sub-assembly, which is in a preferred embodiment of its fifth variant, different from the embodiment shown in the figures.

[0142] 39A-39B, wherein the immovable component 14, together with the pin holder 1, constitutes an integral structural member made of the same homogeneous material, and the second movable component 16 is located in its initial position. FIG. 42C It shows FIG. 42A and FIG. 42B A side view of the needle assembly with the sheath sub-assembly, wherein the second movable component 16 is in its initial position. FIG. 43A and FIG. 43B It shows FIG. 42A-42C A perspective view of the needle assembly and sheath subassembly in a preferred embodiment of the fifth variant, wherein the second movable component 16 is in its final position, and Figure 43C shows a side view of the needle assembly with sheath subassembly of Figures 43A and 43B, wherein the second movable component 16 is in its final position. Detailed Implementation

[0143] The first, second, third, fourth and fifth variations of the sheath sub-assembly of this application and their preferred embodiments are described in detail below.

[0144] In the following description and patent claims, certain terms and expressions are used for the active needle tip sheath subassembly included in the disposable sterile needle assembly according to this application, and for the pen syringe 42 that cooperates with them and includes a primary package 45 with a drug 47, which together constitute the medical needle injection system according to this application, and these terms and expressions should be understood as explained below.

[0145] The full names of the three main aspects of this application are as follows: active sheath subassembly for needle injection tip, disposable sterile needle assembly, and medical needle injection system. For the sake of simplicity, simplified versions of these full names will also be used in this specification, namely, sheath assembly, needle assembly, and needle injection system.

[0146] The term "longitudinal axis" refers to the longitudinal axis or axis of the needle tube 2, which is fixedly and securely embedded in the needle hub 1 and substantially defines the longitudinal axis of the disposable sterile needle assembly. According to this application, the disposable sterile needle assembly includes an active sheath sub-assembly for the needle tip and a pen syringe 42 with a primary packaging 45 that mates with it. The axis or longitudinal axis of the needle tube 2 coincides with the longitudinal axis of the needle assembly, which is labeled as longitudinal axis X in the figure, as shown. FIG. 3 As shown. The term "longitudinal axis X" is used in this specification to simplify the description of the construction and operation of this application; however, it should be understood that all components and structural elements are not axisymmetric or not perfectly axisymmetric. The terms "along," "along the length direction," "longitudinal," or "axial" substantially relate to the longitudinal axis X of the needle tube 2 or the longitudinal axis X of the needle assembly. The term "longitudinal dimension" of a component or structural element substantially relates to the dimension extending along the longitudinal axis X of the needle assembly.

[0147] The term "vertical axis" refers to the axis perpendicular to the longitudinal axis X of the needle assembly, which is labeled "vertical axis Y" or "vertical axis Y1" in the figure.

[0148] In the first, second, third, fourth, and fifth variations of the sheath sub-assemblies presented in this specification, and in preferred embodiments of the needle assembly including these proposed sheath sub-assemblies, according to this application, the "vertical axis Y" intersects the longitudinal axis X and is defined by two opposing pivot protrusions 18 on the immovable component 14, preferably constituting the mounting sleeve 14. The "vertical axis Y" constitutes the rotation axis of the second movable component 16 coupled to the needle injection end sheath 31, as in the first, second, and fifth variations, such as FIG. 4A-4B , FIG. 6A-6C Figures 7-29 and 30-31 and FIG. 3 Figures 38-43 show this substantially and specifically. The "vertical axis Y" also constitutes the axis of rotation of the first movable component 15, which includes a sheath for the non-injection end 5 in a second variant of the sheath subassembly, as shown substantially and specifically in Figures 30-31. However, it should be understood that the vertical axis Y need not intersect the longitudinal axis X of the needle assembly, but can be located away from the longitudinal axis X. The position of the vertical axis Y is determined by the mutual configuration of the components of the sheath subassembly according to this application, including structural and dimensional configurations, which are configured to properly cooperate with each other to correctly realize the function of these components and the entire device.

[0149] In a preferred embodiment of the needle assembly including the third variant of the sheath subassembly described in this application and a preferred embodiment of the third variant of the sheath subassembly presented in this specification, the "vertical axis Y1" is perpendicular to but away from the longitudinal axis X and is defined by a third guide device disposed on the injection end sheath 31 and the first movable component 15, which are rotatably coupled to the second movable component 16, for guiding the rotational movement of the injection end sheath 31 relative to the vertical axis Y1. In a preferred embodiment of the third variant of the sheath subassembly, the third guide device is a distal surface 65 disposed on the first movable component 15, which preferably constitutes the movable sleeve 15, and two opposing curved push surfaces 66 disposed on the injection end sheath 31. The "vertical axis Y1" constitutes the axis of rotation of the injection end sheath 31 in the third variant of the sheath subassembly, as shown substantially and particularly in Figures 6D-6E and Figures 32-34.

[0150] The term "plane defined by the longitudinal axis X and the vertical axis Y perpendicular to the longitudinal axis X of the needle assembly" refers to a plane defined by the longitudinal axis X and the vertical axis Y, in which both the longitudinal axis X and the vertical axis Y are contained when the latter intersects the former. That is, the arrangement of the longitudinal axis X and the vertical axis Y is as shown in the preferred embodiment of the sheath sub-assembly according to this application and the needle assembly including the sheath sub-assembly in the preferred embodiment, as illustrated. "Plane defined by the longitudinal axis X and the vertical axis Y perpendicular to the longitudinal axis X of the needle assembly" includes both the longitudinal axis X and the vertical axis Y. "Plane defined by the longitudinal axis X and the vertical axis Y perpendicular to the longitudinal axis X of the needle assembly" can be imagined to divide the needle assembly into its front and rear portions, thereby allowing the definition of a front view and a rear view of the needle assembly, as well as a side view of the needle assembly and a cross-sectional view of the needle assembly taken along the plane defined by the longitudinal axis X and the vertical axis Y. Therefore, for example, the "front view" of the needle assembly is a view of the needle assembly when the sheath 31 of the injection end is viewed and substantially along the plane defined by the longitudinal axis X and the vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, for example, as FIG. 9B , 10B As shown in 11B, this relates to a first variation of the sheath sub-assembly according to this application.

[0151] However, it should be understood that "the plane defined by the vertical axis X and the vertical axis Y perpendicular to the vertical axis X of the needle assembly" also refers to the plane defined by the vertical axis X and the vertical axis Y. When the latter does not intersect with the former but is far from it, one dimension of this plane extends along the vertical axis X but does not include the vertical axis X, while the other dimension extends along the vertical axis Y and includes the vertical axis Y. That is, the arrangement of the vertical axis X and the vertical axis Y is different from that shown in the figure. For example, "the plane defined by the vertical axis X and the vertical axis Y perpendicular to the vertical axis X of the needle assembly" only includes the vertical axis Y.

[0152] The term "plane of symmetry Z" refers to a plane perpendicular to a plane defined by the longitudinal axis X and the vertical axis Y, and this plane includes the longitudinal axis X and is labeled as plane of symmetry Z in the figure. In the variations and preferred embodiments of the sheath subassembly and needle assembly according to this application presented in this specification, plane of symmetry Z conceivably divides the needle assembly into its substantially symmetrical sides, thereby allowing the definition of a side view of the needle assembly and a cross-sectional view of the needle assembly taken along plane of symmetry Z. Thus, for example, a "side view" of the needle assembly is a view of the needle assembly when the sheath 31 at the injection end is viewed substantially along the direction of plane of symmetry Z, such as... FIG. 9E , 10E As shown in 11E, the "cross-sectional view along the plane of symmetry Z of the needle assembly" is a cross-sectional view of the needle assembly, for example, in FIG. 9C , 10C As shown in 11C, a first variation relates to the sheath sub-assembly according to this application.

[0153] The symmetry plane Z also allows many structural elements to be specified as being arranged relative to each other on the components of the sheath subassembly and the needle assembly, since the term “relatively” or “relative” refers to a position that is substantially located on opposite sides or opposite lateral sides of the sheath subassembly and the needle assembly relative to the symmetry plane Z.

[0154] Certain technical means that are components and structural elements are “structured and dimensionally arranged separately from each other” or “structured and dimensionally arranged separately to enable them to move and engage with each other” or “arranged for mating”, “arranged for mating with each other” or “arranged to fit together”. These terms also include the meaning of “separately shaped or arranged or designed or adapted for mating”, “for mating with each other” or “separately shaped or arranged or configured or adapted to fit together” in order to correctly perform the respective defined functions of a particular technical means or the components or structural elements of these components and the whole device.

[0155] Other similar terms, such as “configured for active encapsulation”, “configured in”, etc., as mentioned above, also mean a structural and dimensional design or design that enables the relevant components or structural elements to properly realize their respective technical functions, which are specified in the specification and claims.

[0156] According to this application, the active sheath sub-assembly for the needle injection end of a disposable sterile needle assembly is "active" because covering the needle injection end 3 and / or the non-injection end 5 requires intentional operation by the user and is performed by the user after injection, unless injection is not performed for some reason; however, it is always performed before the disposable sterile needle assembly is removed from the body 43 of the pen syringe 42. Based on variations of this application and specific embodiments thereof, and based on the injection site in a patient's body, such as the abdomen, thigh, buttocks, etc., and also based on whether the injection is performed independently by the patient or by a medical professional, and based on the specific preferences of the person performing the injection, the user appropriately presses the components of the sheath sub-assembly against a hard auxiliary surface, such as a table or wall surface, to cover the needle injection end 3 and / or the non-injection end 5, and forces the appropriate movable components of the sheath sub-assembly to move.

[0157] According to variations of this application, forced movement refers to the rotational or sliding movement of the second movable component 16 coupled to the sheath 31 of the needle injection end in a direction substantially toward the injection end point 4. In certain preferred embodiments of various variations of this application, forced movement also refers to the rotational movement of the first movable component 15, including the sheath of the needle non-injection end 5, in a direction substantially toward the non-injection end point 6 of the non-injection end 5, as in the second variation of the sheath subassembly, or forced movement refers to the sliding movement of the first movable component 15 along the longitudinal axis X of the needle assembly in a proximal direction away from the injection end point 4, as in the first variation.

[0158] It should be noted that when covering the injection needle tip 3 and / or the non-injection tip 5, the user does not need to bring their fingers close to the injection tip 4, because the covering is achieved through an auxiliary surface such as a tabletop, rather than by directly forcing the second movable component 16 or the first movable component 15 to rotate or slide using one or more fingers. Furthermore, when covering the injection tip 3 and / or the non-injection tip 5, the non-injection tip 5 remains embedded in the septum 46 of the main packaging 45 within the pen syringe 42, thus posing no threat of injury to the user. Therefore, according to this application, the operation of the disposable sterile needle assembly with the active sheath subassembly of the needle injection tip is safe.

[0159] Therefore, the active sheath subassembly for the injection end of the needle according to this application is "active," but operation is safe whether it covers the injection end 3 or the non-injection end 5 of the needle.

[0160] The terms “needle injection end” and “needle non-injection end” refer to the two ends of the needle tube 2 that are fixedly and immovably embedded in the needle hub 1, and therefore also refer to the two sides of the disposable sterile needle assembly and the two directions of movement along the longitudinal axis X. This movement is achieved by the components or structural elements of the entire needle assembly during operation, including the active sheath subassembly of the needle injection end contained therein, and refers to the two directions of movement along the longitudinal axis X, which are performed by the user of the entire needle injection system to perform injection.

[0161] "Needle injection end" refers to the tip of the needle inserted into the patient's body during injection, and the direction in which the needle assembly moves longitudinally towards this end, i.e., the "distal direction." Alternatively, this end is also called the "distal end." The "needle injection end" in the figure is labeled with reference numeral 3.

[0162] "Non-injection end of the needle" refers to the needle end inserted into the body 43 of the pen syringe 42, particularly the needle end inserted into the diaphragm 46 of the primary package 45 containing sterile medicine 47 within the pen syringe, and the direction in which the needle assembly moves longitudinally toward this side, i.e., the "proximal direction". Alternatively, this end is also called the "proximal end". In the figure, the "non-injection end of the needle" is marked with reference numeral 5.

[0163] Furthermore, the terms “distal” and “proximal” in the context of their association with other components or structural elements similarly refer to the two directions of movement along the longitudinal direction of the needle assembly and along the longitudinal axis X, which are realized by the components or structural elements of the entire needle assembly during its operation, and to the two directions of movement along the longitudinal axis X, which are performed by the user of the entire needle injection system to perform injection, i.e., the sides or directions of movement associated with the “needle injection end” and the “needle non-injection end”, respectively.

[0164] The terms “far” and “near” are not relevant to the person administering the injection, that is, whether the patient injects the injection themselves or a medical professional injects it into the patient's body, and regardless of whether the injection is actually completed.

[0165] The needle injection end 3 is "covered" or the needle injection end sheath 31 is in the "covered position of needle injection end 3", which occurs when the second movable component 16 is in its final position, meaning that the injection end point 4 of the injection end 3 does not protrude beyond the distal surface of the needle injection end sheath 31.

[0166] FIG. 1A disposable sterile needle assembly with an active sheath sub-assembly for the needle injection end, according to this application, is shown in the form of a unit package 13 that maintains needle sterility upon arrival at the user, i.e., an individual patient or healthcare worker. The unit package 13 includes an external protective component that protects the needle assembly with the sheath sub-assembly during transport and ensures safe operation by the user during injection preparation. The protective component includes a needle container 11 housing the needle assembly with the sheath sub-assembly, an external needle shield 10 for the needle injection end 3, and a seal 12 that tightly and sterilely seals the needle assembly with the sheath sub-assembly. The seal 12 maintains the sterility of the needle assembly and is removed before the needle assembly is screwed onto a pen syringe 42. The remaining protective components, namely the needle container 11 of the needle assembly and the outer needle shield 10 for the needle injection end 3, remain in the state they were in during the manufacturing process of the needle assembly during the mounting of the needle assembly onto the pen syringe 42, and are only removed at the last minute before injection. According to this application, the needle assembly with the sheath sub-assembly and the unit package 13 are designed to prevent them from being resealed by the seal 12 when the unit package 13 is first opened. Once the unit package 13 is opened, it indicates that the needle assembly contained therein has lost its sterility.

[0167] FIG. 2 An exploded perspective view of the unit package 13 and its aforementioned protective components, as well as the components of the needle assembly with a sheath subassembly according to this application, is shown. An external needle shield 10 for the needle injection end 3 can be seen in this figure, which may or may not be present in the unit package 13.

[0168] The figure also shows that the sheath subassembly according to this application does not include the optional external needle shield 10, nor does it include the unit package 13, i.e., the needle container 11 and the seal 12, or the standard needle hub 1. In the first, second, third, and fourth variations, it includes only three components, and in the fifth variation, it includes only two components. In the first, second, third, and fourth variations, these components are the non-movable component 14, preferably the mounting sleeve 14, the first movable component 15, preferably the movable sleeve 15, and the second movable component 16 coupled to the injection end sheath 31. In the fifth variation, these components are the non-movable component 14, preferably the mounting sleeve 14, and the second movable component 16 coupled to the injection end sheath 31.

[0169] It should also be noted that in certain preferred embodiments of all variations of the sheath subassembly according to this application, the immovable component 14 can be made as a single integral structure of the same homogeneous material together with the needle hub 1. This means that in these embodiments, the entire needle assembly according to this application includes only three components (not shown in the figures) in the first, second, third, and fourth variations and only two components in the fifth variation. These components are, in these particular preferred embodiments, in the first, second, third, and fourth variations—the needle hub 1 together with the technical means assigned to the immovable component 14, the first movable component 15, and the second movable component 16 coupled to the injection end sheath 31, and in the fifth variation—the needle hub 1 together with the technical means assigned to the immovable component 14 and the second movable component 16 coupled to the injection end sheath 31. Figures 39 A-39 B and FIG. 42A -42 C, 43 A-43 C illustrate this preferred embodiment of a fifth variation of the sheath sub-assembly according to this application.

[0170] FIG. 3 A longitudinal cross-sectional view of a needle hub 1 with a needle tube 2 is shown, in which the needle tube 2 is fixedly and immovably embedded, for example by an adhesive connector, together forming a disposable sterile needle assembly according to this application and simultaneously meeting the requirements defined by ISO 11608. The axis of the needle tube 2 defines the longitudinal axis X of the needle assembly with the sheath subassembly and the entire needle injection system. The axis of the needle tube 2 coincides with the longitudinal axis X of the needle assembly. According to this application, the needle hub 1 with the needle tube 2 and the sheath subassembly mounted thereon extend substantially around the axis of the needle tube 2 and therefore around the longitudinal axis X of the needle assembly. The needle tube 2 has two ends, namely, a needle injection end 3 with an injection endpoint 4, which is inserted into the patient for injection, and a needle non-injection end 5 with a non-injection endpoint 6, which is screwed into the wall material of the diaphragm 46 of the primary package 45 located within the body 43 of the pen syringe 42 for drawing sterile medicine 47 contained in the primary package 45.

[0171] The needle hub 1 has a groove 7, which is limited from the proximal side by the proximal edge 8 of the wall of the needle hub 1. An internal thread 9 is formed on the surface of the groove 7, which is configured to mate with an external thread 44 formed on the body 43 of the pen syringe 42 to form a threaded connection between these components of the needle injection system, such as... FIG. 25-29As shown. The threaded connection between the needle hub 1 and the pen syringe 42 allows the needle assembly to be easily mounted onto the pen syringe 42 by piercing the diaphragm 46 of the primary packaging 45 with the non-injection end 5 of the needle having the non-injection end 6, and then easily removed from the pen syringe 42. The internal thread 9 in the groove 7 of the needle hub 1 and the external thread 44 on the body 43 of the pen syringe 42 constitute an exemplary connection device for detachably connecting the needle hub 1 with the sheath sub-assembly to the pen syringe 42.

[0172] FIG. 4A and 4B A longitudinal cross-sectional view and a perspective view of the immovable component 14 are shown, including technical means that enable its application to first, third, and fourth variations of the sheath subassembly. These technical means are respectively assigned to the immovable component 14 in these second and fifth variations after the addition of certain technical means specific to the second and fifth variations of the sheath subassembly. The immovable component 14 is preferably a mounting sleeve 14, such as... FIG. 4A and 4B As shown, it can be applied to these second and fifth variations respectively.

[0173] In this preferred embodiment, the immovable component 14 is a mounting sleeve 14, which extends substantially axially along the needle seat 1 and has a proximal edge 22 from the proximal side. Longitudinal ribs are designed on the inner circumferential surface of the mounting sleeve 14 to immovably mount the mounting sleeve 14 onto the needle seat 1 by a non-removable plastic fastener. Other types of fastening, such as interference fastening, press-fit fastening, forced fastening, or adhesive fastening, can be used between the immovable component 14 (preferably the mounting sleeve 14) and the needle seat 1 to permanently embed the immovable component 14 into the needle seat 1. Two opposing longitudinal protrusions 21 are designed on the outer circumferential surface of the mounting sleeve 14 to achieve a movable sliding connection with the first movable component 15. These two opposing longitudinal protrusions 21 are not required in embodiments of the immovable component 14, and the immovable sleeve 14 is preferred, as used in the second and fifth variations of the sheath subassembly. On the outer circumferential surface of the mounting sleeve 14, there are two opposing pivot protrusions 18, each of which has a handle 19 and a retaining disc 20.

[0174] In the first, second, third and fourth variations of the sheath sub-assembly according to this application, the pivot protrusion 18 with handle 19 is an exemplary technical means for engaging the first movable component 15 with the immovable component 14.

[0175] In the first, second, and fifth variations of the sheath subassembly according to this application, the pivot protrusion 18 with handle 19 is also an exemplary technical device for rotatably mounting the second movable component 16 relative to the vertical axis Y on the immovable component 14, wherein the vertical axis Y is perpendicular to the longitudinal axis X of the needle assembly, and for engaging the immovable component 14 with the second movable component 16 and for guiding the second movable component 16 to rotate.

[0176] In the fifth variant, the pivot protrusion 18 and the handle 19, along with additional technical means specific to the fifth variant and designed at the proximal end of the mounting sleeve 14, constitute an exemplary technical means for guiding the second movable component 16 to rotate, namely the first proximal protrusion 68 and the second proximal protrusion 69, and for engaging the immovable component 14 with the second movable component 16, namely the second proximal protrusion 69 and its guiding surface 70.

[0177] In the third and fourth variations of the sheath subassembly according to this application, the pivot protrusion 18 and the handle 19 are exemplary technical means for engaging the immovable component 14 with the second movable component 16, and slidably mounting the second movable component 16 on the immovable component 14 in a direction perpendicular to the longitudinal axis X of the needle assembly and substantially toward the longitudinal axis X of the needle assembly, and guiding the second movable component 16 to slide.

[0178] In the first, second, third, fourth and fifth variations of the sheath subassembly according to this application, the retaining disc 20 formed on the outer end of the handle 19 of the pivot protrusion 18 is an exemplary technical means for protecting the second movable component 16 from slipping off the immovable component 14.

[0179] Furthermore, in the first, second, third, and fourth variations of the sheath sub-assembly according to this application, the pivot protrusion 18 with handle 19 is also an exemplary means of holding the first movable component 15 and the second movable component 16 in their initial and final positions. In the fifth variation of the sheath sub-assembly according to this application, the pivot protrusion 18 with handle 19, as well as the additional means unique to the fifth variation and designed on the proximal end of the mounting sleeve 14—namely, the first proximal protrusion 68 and the second proximal protrusion 69 with guide surface 70—also constitute exemplary means of holding the second movable component 16 in its initial and final positions, respectively.

[0180] In a second variation of the sheath subassembly according to this application, a pivoting protrusion 18 with a handle 19 is an exemplary technical means for engaging the first movable component 15 with the immovable component 14, and for rotatably mounting the first movable component 15 onto the immovable component 14 about a vertical axis Y, which is perpendicular to the longitudinal axis X of the needle assembly, and for guiding the rotational movement of the first movable component 15. A retaining disc 20 formed on the outer end of the handle 19 of the pivoting protrusion 18 is an exemplary technical means for protecting the first movable component 15 from slipping off the immovable component 14.

[0181] The immovable component 14 is configured as a component substantially symmetrical with respect to an imaginary plane of symmetry Z, and preferably constitutes a mounting sleeve 14 in all variations and preferred embodiments of the present application shown in this specification and accompanying drawings. In all variations and preferred embodiments of the present application shown in this specification and accompanying drawings, the immovable component 14 can be manufactured together with the pin seat 1 as a single integral structure made of the same homogeneous material (preferably plastic).

[0182] Other technical functions of the immovable component 14, preferably the immovable sleeve 14, and exemplary technical means for performing these technical functions, applied to the preferred embodiment of the presented immovable component 14, will be described below in the description of various variations of the sheath sub-assembly according to this application.

[0183] exist FIG. 5A and FIG. 5B as well as FIG. 5C and FIG. 5D The image shows a perspective view of a first movable component 15, which in these preferred embodiments constitutes a movable sleeve 15, and is included in a first variant and a third and fourth variant of the sheath subassembly according to this application.

[0184] like FIG. 5A and FIG. 5B as well as FIG. 5C and FIG. 5D As shown, two opposing longitudinal grooves 23 are designed on the wall of the movable sleeve 15, protruding outward from the wall of the movable sleeve 15, and each groove includes a longitudinal cutout 24. The movable sleeve 15 has a distal surface 65 designed at its distal end.

[0185] like FIG. 5A and FIG. 5BAs shown, in an embodiment of the movable sleeve 15 used in a first variant of the sheath subassembly, a flange 25 extending circumferentially at the proximal end 25 is provided. The flange 25 is designed with two opposing through holes that are blocking holes 26, which to some extent constitute an extension of the longitudinal cutout 24 in the flange 25. The flange 25 has a proximal surface 27 and a distal surface 28.

[0186] like FIG. 5C and FIG. 5D As shown, embodiments of the movable sleeve 15 used in the third and fourth variations of the sheath subassembly have two opposing proximal protrusions 62 on the proximal end 25, which are designed to extend outward below the longitudinal cutout 24, and each proximal protrusion has a guide surface 63 and a blocking surface 64.

[0187] In the first, third, and fourth variations of the sheath subassembly, the longitudinal groove 23 is an exemplary technical means for slidably mounting the first movable component 15 on the immovable component 14 relative to the longitudinal axis X of the needle assembly in the proximal direction, and for guiding the first movable component 15 to slide. In the first, third, and fourth variations of the sheath subassembly, the first movable component 15 is movable between its initial and final positions, in which it extends substantially longitudinally along the longitudinal axis X of the needle assembly.

[0188] In the first, third, and fourth variations of the sheath subassembly, two opposing longitudinal cutouts 24 are exemplary technical means for engaging the first movable component 15 with the immovable component 14.

[0189] In a first variant of the sheath subassembly, the distal surface 28 of the proximal end 25 is an exemplary technical means for engaging the first movable component 15 with the second movable component 16 and for guiding the rotational movement of the second movable component 16 on the first movable component 15 relative to the vertical axis Y, which is perpendicular to the longitudinal axis X of the needle assembly, and for holding the first movable component 15 and the second movable component 16 in their initial and final positions.

[0190] In a first variant of the sheath subassembly, two opposing through-holes 26 in the distal surface 28 of the proximal end 25 and in the flange 25 are exemplary means of preventing the first movable component 15 and the second movable component 16 from reversibly blocking each other in their final positions.

[0191] In a first variant of the sheath subassembly, the distal surface 28 of the proximal end 25 is an exemplary technical means for forcing the first movable component 15 to slide about the longitudinal axis X of the needle assembly in the proximal direction, and for displacing the first movable component 15 from its initial position to its final position.

[0192] In the third and fourth variations of the sheath subassembly, two opposing proximal protrusions 62 and their two opposing distal surfaces, namely guide surfaces 63, are exemplary technical means for engaging the first movable component 15 with the second movable component 16, and guiding the second movable component 16 to slide on the first movable component 15 perpendicular to the longitudinal axis X of the needle assembly and substantially toward the longitudinal axis X of the needle assembly, and holding the first movable component 15 and the second movable component 16 in their initial and final positions.

[0193] In the third and fourth variations of the sheath subassembly, two opposing proximal protrusions 62 of the two opposing guide surfaces 63 and the two opposing blocking surfaces 64 are exemplary technical means for irreversibly blocking the first movable component 15 and the second movable component 16 from each other in their final positions.

[0194] In a third variation of the sheath subassembly, the distal surface 65 of the first movable component 15, preferably the movable sleeve 15, is an exemplary technical means for engaging the first movable component 15 with the injection end sheath 31 rotatably coupled to the second movable component 16, and for guiding the injection end sheath 31 to rotate about a vertical axis Y1 on the first movable component 15, the vertical axis Y1 being perpendicular to the longitudinal axis X of the needle assembly and moving away from the longitudinal axis X of the needle assembly.

[0195] In the first, second, third, and fourth variations of the sheath subassembly shown in this specification and the accompanying drawings, and in its preferred embodiment, the injection end 3 with the needle tip 4 is not covered in the initial position of the first movable component 15, while in the final position of the first movable component 15, the injection end 3 with the needle tip 4 is covered.

[0196] In the first, second, third, and fourth variations of the sheath subassembly shown in this specification and the accompanying drawings, and in its preferred embodiment, the first movable component 15 is designed as a component substantially symmetrical with respect to an imaginary plane of symmetry Z, and in the first, third, and fourth variations of the sheath subassembly, it is preferably designed as a movable sleeve 15.

[0197] Other technical functions of the first movable component 15, preferably the movable sleeve 15, and exemplary technical means for performing these technical functions in the presented preferred embodiments of the first movable component 15, will be described below in the description of various variations of the sheath subassembly according to this application.

[0198] FIG. 6A and FIG. 6B-6C Perspective views of the second movable component 16 in two preferred embodiments are shown, which are respectively applied in the first and fifth variations of the sheath subassembly according to this application, and FIG. 6D-6E and FIG. 6F-6G A perspective view of the second movable component 16 in the preferred embodiment is shown, which are applied in the third and fourth variations of the sheath subassembly according to this application, respectively.

[0199] The second movable component 16 is non-detachably and fixedly coupled to the injection end sheath 31 and is designed as a component substantially symmetrical with respect to an imaginary plane of symmetry Z, as shown in all variations and preferred embodiments of this application, which are illustrated in this specification and drawings. It is manufactured together with the injection end sheath 31 as an integral structural member of the same homogeneous material, preferably plastic. In other words, the second movable component 16 includes the injection end sheath 31 and, preferably, is integrally formed with it as a single component made of the same material.

[0200] As shown in Figures 6A and 6B-6C, in two preferred embodiments of the first and fifth variations for the sheath subassembly, the second movable component 16 has two opposing arms 33, one end of each arm extending into the wall connecting them to form an injection end sheath 31 and a rotatable abutment surface 32, and at the other end of each arm 33, successively forming a shaped hole 34, a first tongue 35, a bending push surface 36, a second tongue 37, a first blocking surface 38, and a second limiting surface 39. FIG. 6B-6C In the preferred embodiment shown, the second movable component 16 is substantially alternately shaped with a hole 34 and a first tongue 35, and also has a first limiting surface 30 between the ends of each arm 33, the first limiting surface 30 being configured to engage with the distal surface 28 of the proximal end 25, which is in the form of a flange 25 of the movable sleeve 15.

[0201] In the first and fifth variations of the sheath subassembly, the shaped hole 34 and the first tongue 35 of each of the two opposing arms 33 are exemplary means of engaging the second movable component 16 with the immovable component 14 and of protecting the second movable component 16 from slipping off the immovable component 14, and of rotatably mounting the second movable component 16 onto the immovable component 14 relative to the vertical axis Y, wherein the vertical axis Y is perpendicular to the longitudinal axis X of the needle assembly, and together with the bending push surface 36 and the second tongue 37, are exemplary means of guiding the second movable component 16 to rotate.

[0202] In the first and fifth variations of the sheath subassembly, the second movable component 16 is movable between its initial position and its final position, in which the second movable component 16 extends substantially perpendicular to the longitudinal axis X of the needle assembly, and in the final position, the second movable component 16 extends substantially longitudinally relative to the longitudinal axis X of the needle assembly.

[0203] In all variations and preferred embodiments of this application set forth in this specification and drawings, the injection end 3 with the needle tip 4 is not covered in the initial position of the second movable component 16, while in the final position of the second movable component 16, the injection end 3 with the needle tip 4 is covered.

[0204] In a first variant of the sheath subassembly, the first tongue 35, the curved push surface 36, and the second tongue 37 of each of the two opposing arms 33 are exemplary technical means for engaging the second movable component 16 with the first movable component 15.

[0205] In the first and fifth variations of the sheath subassembly, it is disposed on the second movable component 16, particularly as... FIG. 6A and FIG. 6B-6C The rotatable abutment surface 32 on the injection end sheath 31 shown is an exemplary technical means for forcing the second movable component 16 to rotate relative to the vertical axis Y, wherein the vertical axis Y is perpendicular to the longitudinal axis X of the needle assembly, and for displacing the second movable component 16 from its initial position to its final position.

[0206] In a first variant of the sheath subassembly, the first blocking surface 38 and the second limiting surface 39 of each of the two opposing arms 33 are exemplary means of irreversibly blocking the second movable component 16 and the first movable component 15 in their final positions. In a fifth variant of the sheath subassembly, the first blocking surface 38 and the second limiting surface 39 of each of the two opposing arms 33 are exemplary means of irreversibly blocking the second movable component 16 in its final position, in the non-movable component 14.

[0207] In a preferred embodiment of the second movable component 16 in the third variant for the sheath subassembly, such as FIG. 6D-6E As shown, the injection end sheath 31 is fixedly coupled to the second movable component 16 and rotates relative to it. This rotation is facilitated by a special narrowing or contraction of the material at its coupling point. The second movable component 16, together with the injection end sheath 31, is constructed with structural details that are substantially symmetrical with respect to an imaginary plane of symmetry Z. The second movable component 16 has two opposing arms 33, one end of each arm extending into an arcuate wall that connects to them to form a clamp, which is coupled distally to the rotatable injection end sheath 31. The arms 33 extend toward the other end in the form of opposing straight walls, within which coupling slots 56 with proximal surfaces 57 are designed. FIG. 6D-6E In a preferred embodiment of the second movable component 16 shown, the coupling slot 56 has a straight shape, and therefore its proximal surface 57 is also straight. On the proximal side, each arm 33 has a fifth limiting surface 61, a second blocking surface 60, a pushing surface 59, and a fourth limiting surface 58, sequentially mentioned in the direction toward its other end. On the proximal side, each arm 33 has a proximal surface in the shape of a virtual straight line, segments of which constitute the fifth limiting surface 61, the second blocking surface 60, the pushing surface 59, and the fourth limiting surface 58, sequentially mentioned in the direction toward the other end of the arm 33.

[0208] In a third variation of the sheath subassembly, two opposing curved push surfaces 66 disposed on the injection end sheath 31 are exemplary technical means for engaging the injection end sheath 31 with the first movable component 15, preferably the movable sleeve 15, and for guiding the rotational movement of the injection end sheath 31 relative to the vertical axis Y1 on the first movable component 15, the vertical axis Y1 being perpendicular to the longitudinal axis X of the needle assembly and moving away from the longitudinal axis X of the needle assembly.

[0209] In a third variation of the sheath subassembly, the shape of the coupling slot 56 with the proximal surface 57 is structurally and dimensionally configured to interact with the shape of the proximal surface of the arm 33 and the remaining structural elements of the second movable component 16, including the shape of the bending push surface 66 of the injection end sheath 31, and the remaining components of the needle assembly, so that during the displacement of the second movable component 16 relative to the immovable component 14 and the first movable component 15 from its initial position to its final position, the injection end sheath 31 is guided to effectively cover the injection end 3 when the second movable component 16 reaches its final position.

[0210] In a preferred embodiment of the second movable component 16 of the fourth variant for the sheath subassembly, such as FIG. 6F-6G As shown, the injection end sheath 31 is fixedly and immovably coupled to the second movable component 16. The second movable component 16, together with the injection end sheath 31, is constructed with structural details substantially symmetrical with respect to an imaginary plane of symmetry Z. The second movable component 16 has two opposing arms 33, one end of each arm extending into an arcuate wall that connects them together to form a clamp. At the distal end, on the portion of the arms 33 extending toward the clamp, the arms 33 transform into a completely flat distal wall extending between them and the clamp, forming the injection end sheath 31. The arms 33 extend toward their other end to form opposing straight walls, wherein opposing coupling slots 56 with proximal surfaces 57 are designed. FIG. 6F-6G In a preferred variant of the second movable component 16 shown, the coupling slot 56 is in the shape of a dashed straight line, and therefore its proximal surface 57 is also a dashed straight line. On the proximal side, each arm 33 has a proximal surface in the shape of a broken line, the segments of which form, in the direction toward the other end of the arm 33, the fifth limiting surface 61, the second blocking surface 60, the straight pushing surface 59, and the fourth limiting surface 58, which are raised sequentially.

[0211] In a fourth variant of the sheath subassembly, the shape of the coupling slot 56 having the proximal surface 57 is structurally and dimensionally configured to interact with the shape of the proximal surface of the arm 33 and the remaining structural elements of the second movable component 16 and the remaining components of the needle assembly, so that during the displacement of the second movable component 16 from its initial position to its final position relative to the immovable component 14 and the first movable component 15, the injection end sheath 31 is guided to effectively bend the injection end 3 and its effective coverage in the final position of the second movable component 16.

[0212] The injection end sheath 31 has a proximal surface configured to cover the injection end 3 of the needle, preferably for bending the needle tube 2, and completely covering the bent injection end 3 of the needle. The outer surface of the clamp-shaped arc-shaped wall forms a slidable abutment surface 67.

[0213] In the third and fourth variations of the sheath subassembly, two opposing coupling slots 56 on the two opposing arms 33 are exemplary technical means for engaging the second movable component 16 with the immovable component 14 (preferably the mounting sleeve 14), and for protecting the second movable component 16 from slipping off the immovable component 14, and for slidably mounting the second movable component 16 on the immovable component 14 in a direction perpendicular to the longitudinal axis X of the needle assembly and substantially toward the longitudinal axis X of the needle assembly.

[0214] In the third and fourth variations of the sheath subassembly, two opposing coupling slots 56 and two opposing fourth limiting surfaces 58 on two opposing arms 33 are exemplary means of holding the second movable component 16 and the first movable component 15, preferably the movable sleeve 15, in their initial positions, while two opposing push surfaces 59 together are exemplary means of guiding the sliding of the second movable component 16. The two opposing fourth limiting surfaces 58, together with the two opposing push surfaces 59 on the two opposing arms 33, are used to engage the second movable component 16 with the first movable component 15.

[0215] In the third and fourth variations of the sheath subassembly, the two opposing coupling slots 56 and the two opposing fifth limiting surfaces 61 on the two opposing arms 33 are exemplary technical means for holding the second movable component 16 and the first movable component 15 in their final positions.

[0216] In the third and fourth variations of the sheath subassembly, the slidable abutment surface 67 is an exemplary technical means for forcing the second movable component 16 to slide perpendicular to and substantially toward the longitudinal axis X of the needle assembly, and for displacing the second movable component 16 from its initial position to its final position.

[0217] In the third and fourth variations of the sheath subassembly, two opposing second blocking surfaces 60 and two opposing fifth limiting surfaces 61 on two opposing arms 33 are exemplary technical means for irreversibly blocking the second movable component 16 and the first movable component 15 from each other in their final positions.

[0218] Other technical functions of the second movable component 16 and exemplary technical means for performing these technical functions, which are applied in preferred embodiments of the presented second movable component 16, will be described below in the description of various variations of the sheath sub-assembly according to this application.

[0219] exist FIG. 7A-7B and FIG. 8A-8B The diagram illustrates the application of a supplementary sheath for the non-injection end 5, designed to be disposed in a recess 7 or an extended recess 7 of the needle hub 1 after the needle assembly has been removed from the pen syringe 42. Specifically, it illustrates the application of a cork 41, preferably coupled to a movable sleeve 15, and the application of a dome 17 of the needle container 11 of the needle assembly. The cork 41 and dome 17 are respectively configured to mate with the proximal end of the needle assembly after removal from the pen syringe 42. This means that their shapes depend on the deformation of the needle assembly and the preferred embodiment of the shape corresponding to a single deformation of the needle assembly. In this context, it should be noted that the term "extended recess 7 of the needle hub 1" refers to a recess formed proximally on the needle assembly, visible after removal of the needle assembly from the pen syringe 42, and in these preferred embodiments of the sheath subassembly, wherein at least one of the immovable component 14 and the first movable component 15 protrudes beyond the proximal edge 8 of the needle hub 1, at least in the final position of the first movable component 15. These supplementary sheaths for the non-injection end 5 complement the coverage function of the needle tip, which is already achieved in needle assemblies having an active sheath sub-assembly for the injection end according to this application, due to the separate configuration of the immovable component 14 and the movable component 15, and depending on the variant of the needle sub-assembly under consideration and the specific preferred embodiment. The application of any supplementary sheath for the non-injection end 5 is also related to the needs of the individual customer or the intended use location or usage restrictions of the needle assembly, which involves the required level of safety. One of these supplementary sheaths can be applied to the non-injection end 5 where complete coverage of the non-injection end 5 is absolutely necessary after the needle assembly has been removed from the pen syringe 42.

[0220] Although FIG. 7A-7B and FIG. 8A-8B As shown, the basics are as follows FIG. 1-2 The application of an additional sheath on the non-injection end 5 in the sheath assembly in the preferred embodiment of the first variant is shown, but it should be noted that such an additional sheath on the non-injection end 5 can be applied to each of the remaining variants of the sheath assembly after taking into account structural and dimensional modifications suitable for particular variants and preferred embodiments.

[0221] Detailed supplementary description of the first variant of the sheath sub-assembly according to this application in its preferred embodiment Figures 9-11, 12-14, 15-17, and 18 illustrate a needle assembly with a sheath sub-assembly according to a first variant of this application, in the subsequent state and stage of its operation after the needle assembly is ready for injection, i.e., after the protective components of the unit package 13, namely the needle container 11, the outer needle shield 10 for the needle injection end 3, and the seal 12, have been removed from the needle assembly, as shown in Figures 1-3. Therefore, FIG. 9A-9E , FIG. 12A-12E , FIG. 15A-15B and FIG. 18A-18E A needle assembly with a second movable component 16 and a movable sleeve 15 is shown, wherein the second movable component 16 and the movable sleeve 15 are in their initial positions. FIG. 10A-10E , FIG. 13A-13E and FIG. 16A-16B A needle assembly with a second movable component 16 and a movable sleeve 15 is shown, wherein the second movable component 16 and the movable sleeve 15 are in an intermediate position between their initial and final positions, and FIG. 11A-11E , FIG. 14A-14E and FIG. 17A-17B A needle assembly with a second movable component 16 and a movable sleeve 15 in its final position is shown. The needle assembly shown in Figures 9-11, 12-14, and 15-17 is mounted on a pen syringe 42.

[0222] Meanwhile, the needle holder 1 used in the first variation is as follows FIG. 3 As shown and combined with the above text FIG. 3 As described, the immovable component 14 used in this embodiment, in the form of a mounting sleeve 14, is as follows: FIG. 4A-4B As shown and combined with the above text FIG. 4A-4B As described, the first movable component 15, which is in the form of a movable sleeve 15, is used in this embodiment as follows: FIG. 5A-5B As shown and combined with the above text FIG. 5A-5B As described, the second movable component 16 used in this embodiment is as follows: FIG. 6A-6C As shown and combined with the above text FIG. 6A-6C It has been described.

[0223] In a preferred embodiment of its first variation, the sheath subassembly includes: a mounting sleeve 14, which is immovably mounted on the needle hub 1 and extends substantially longitudinally along the longitudinal axis X of the needle assembly; a movable sleeve 15, which is slidably mounted on the mounting sleeve 14 along the longitudinal axis X in a proximal direction; and a second movable component 16, which is rotatably mounted on the mounting sleeve 14 about a vertical axis Y, wherein the vertical axis Y is perpendicular to the longitudinal axis X of the needle assembly.

[0224] Mounting sleeve 14 has two opposing pivot protrusions 18 on its circumferential outer surface, each pivot protrusion having a handle 19 and a retaining disc 20. These two opposing pivot protrusions 18 define a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, which is a non-removably coupled axis of rotation for securing the injection end sheath 31 to the second movable component 16.

[0225] The movable sleeve 15 and the second movable component 16 are movable between their initial and final positions, wherein the movable sleeve 15 extends substantially longitudinally along the longitudinal axis X of the needle assembly. The second movable component 16 extends substantially perpendicularly to the longitudinal axis X of the needle assembly in its initial position, and extends substantially longitudinally along the longitudinal axis X in its final position.

[0226] In a first variation of the sheath subassembly according to this application, the mounting sleeve 14, the movable sleeve 15, and the second movable component 16 are configured to cooperate with each other, and the movable sleeve 15 and the second movable component 16 are kinetically engaged with each other such that activation of the injection end sheath 31 is achieved by forcing the second movable component 16 to rotate and causing the movable sleeve 15 to slide between its initial and final positions, respectively.

[0227] Figures 9-11, 12-14, 15-17, and 18 illustrate a preferred embodiment of a first variant of a sheath subassembly having a movable sleeve 15 and a second movable component 16, which are respectively configured to activate the injection end sheath 31 by forcing rotational movement of the second movable component 16, which causes the movable sleeve 15 to slide.

[0228] Figures 19-21 illustrate a method for activating the needle tip sheath 31 by forcing the second movable component 16 to rotate about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly and toward the needle tip 3. To cover the needle tip 3, when holding the body 43 of the pen syringe 42, the user presses the second movable component 16 against any hard surface, such as a table or tray, via the rotatable abutment surface 32, forcing the second movable component 16 with the needle tip sheath 31 to rotate toward the injection tip 3 with the needle tip 4. During rotation, the second movable component 16 causes the movable sleeve 15 to slide axially along the needle hub 1 in the proximal direction.

[0229] In a first variant of the sheath subassembly according to this application, activation of the injection end sheath 31 can also be achieved by forcing the movable sleeve 15 to slide while simultaneously causing the second movable component 16 to rotate, between the initial and final positions of each of the movable components, namely the movable sleeve 15 and the second movable component 16.

[0230] Figure 18 illustrates a preferred embodiment of a first variant of the sheath subassembly, wherein the movable sleeve 15 and the second movable component 16 are respectively configured such that the injection end sheath 31 can be activated by forcing the sliding of the movable sleeve 15, which causes the second movable component assembly 16 to rotate.

[0231] FIG. 22-24 A method is shown for activating the needle tip sheath 31 by forcing the movable sleeve 15 to slide proximally relative to the longitudinal axis X of the needle assembly. To cover the needle tip 3, when holding the body 43 of the pen syringe 42, the user presses the movable sleeve 15 against any hard surface, such as a table, via the distal surface 28 of the flange 25, forcing the movable sleeve 15 to move proximally along the length of the needle hub 1. During sliding, the movable sleeve 15 causes the second movable component 16, together with the tip sheath 31, to rotate toward the tip 3 with the needle tip 4.

[0232] The first variant of the sheath subassembly in the preferred embodiment shown in Figure 18 can activate the injection end sheath 31, either by forcing rotational movement of the second movable component 16 or by forcing sliding movement of the movable sleeve 15. In the preferred embodiment of the first variant of the sheath subassembly according to this application, as shown in Figure 18, movement of one of the freely selected first movable component 15 and second movable component 16, activated by the user, causes movement of the other, respectively, between the initial and final positions of each of the first movable component 15 and the second movable component 16. In other words, activation of movement of any of the movable components, namely the first component 15 and the second component 16, results in substantially simultaneous activation of movement of the other. Similarly, activation of movement of any of the movable components, namely the first component 15 and the second component 16, will result in activation of the injection end sheath 31.

[0233] Figures 9-11 illustrate a first variant of the needle assembly with a sheath subassembly according to this application. In a preferred embodiment, it has a long first movable component 15 in the form of a movable sleeve 15, such that, in the initial position of the second movable component 16, it protrudes in the proximal direction beyond the proximal edge 8 of the needle hub 1 and the proximal edge 22 of the mounting sleeve 14. The needle assembly is mounted on a pen syringe 42. During the coverage of the injection end 3, the movable sleeve 15 travels a long distance in the proximal direction along the longitudinal axis X of the needle assembly between its initial and final positions. In a preferred embodiment of a first variant of the sheath subassembly according to this application, as shown in Figures 9-11, the immovable component 14, i.e., the mounting sleeve 14, extends along the length direction of the needle hub 1, with its length dimension such that it does not protrude beyond the proximal edge 8 of the needle hub 1 in the proximal direction. Thus, in the initial or final position of the first movable component 15, i.e., the movable sleeve 15, and thus in the initial or final position of the second movable component 16, it does not form a sheath for the non-injection end 5, or does not form a sheath for the non-injection end 5 together with the needle hub 1.

[0234] Figures 12-14 illustrate a needle assembly with a first variant of the sheath subassembly according to this application, having a second movable component 16 of another preferred embodiment, different from the embodiments shown in Figures 6A-6C and 9-11, and having a long movable sleeve 15 such that, in the initial position, the second movable component 16 protrudes in the proximal direction beyond the proximal edge 8 of the needle hub 1 and the proximal edge 22 of the mounting sleeve 14. During encapsulation of the injection end 3, the movable sleeve 15 travels a very short distance in the proximal direction along the longitudinal axis X of the needle assembly between its initial and final positions. In a preferred embodiment of the first variant of the sheath subassembly according to this application, as shown in Figures 12-14, the fixing component 14, i.e., the mounting sleeve 14, extends along the length direction of the needle hub 1, with a longitudinal length such that it does not protrude beyond the proximal edge 8 of the needle hub 1 in the proximal direction. As a result, a sheath of the non-injection end 5 is not formed at the initial or final position of the first movable component 15, i.e., the movable sleeve 15, or it does not form a sheath of the non-injection end 5 together with the needle hub 1. Consequently, a sheath of the non-injection end 5 is also not formed at the initial or final position of the second movable component 16.

[0235] Conversely, Figures 15-17 show a needle assembly with a first variant of the sheath sub-assembly according to this application, in such a way as FIG. 1-2 and FIG. 6AThe preferred embodiment shown has a second movable component 16 and a short movable sleeve 15, which, in the initial position, does not protrude in the proximal direction from the proximal edge 8 of the needle hub 1 or the proximal edge 22 of the mounting sleeve 14. In a preferred embodiment of a first variant of the sheath subassembly according to this application, as shown in Figures 15-17, the non-movable component 14, i.e., the mounting sleeve 14, extends axially along the needle hub 1, its longitudinal dimension causing it to protrude in the proximal direction from the proximal edge 8 of the needle hub 1, thereby forming, or together with, the sheath of the non-injection end 5 in the initial and final positions of the first movable component 15, i.e., the movable sleeve 15, and thus forming, in the initial and final positions of the second movable component 16, the sheath of the non-injection end 5. During the coverage of the injection end 3, the movable sleeve 15 travels a long distance along the longitudinal axis X of the needle assembly in the proximal direction between its initial and final positions, such that in its final position it protrudes beyond the proximal edge 8 of the needle hub 1 in the proximal direction, but does not protrude beyond the proximal edge 22 of the mounting sleeve 14. In this preferred embodiment, the sheath assembly is provided with a very long mounting sleeve 14, which also protrudes beyond the proximal surface 27 of the flange 25 of the movable sleeve 15 in both the initial and final positions in the proximal direction. In this way, this long mounting sleeve 14 elongates the sheath for the non-injection end 5 in the proximal direction with respect to the needle hub 1. At the same time, the sheath for the non-injection end 5 formed by the mounting sleeve 14 extends around the entire circumference of the groove formed by the extended groove 7 of the needle hub 1.

[0236] FIG. 18A-18E A first variant of the needle assembly with a sheath subassembly according to this application is shown. In a preferred embodiment, it differs from the embodiment shown in Figures 9-17, wherein the movable sleeve 15 has opposing pivot protrusions 29 at its proximal end for engaging with opposing third limiting surfaces 40 respectively provided on the second movable component 16. This allows the user to rotate the second movable component 16 about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly in a direction toward the needle injection end 3, but this is achieved by forcing the movable sleeve 15 to slide along the longitudinal axis X of the needle assembly in the proximal direction. In this preferred embodiment of the sheath subassembly shown in Figures 18A-18E, the user can perform active coverage of the injection end 3 by forcing the rotational movement of the second movable component 16 that causes the movable sleeve 15 to slide, or by forcing the sliding movement of the movable sleeve 15 that causes the rotational movement of the second movable component 16.

[0237] In order to force the movable sleeve 15 to slide, as shown in... FIG. 18A-18EIn a preferred embodiment of the first variation of the sheath assembly shown, a slidable abutment is designed on the movable sleeve 15, which is the distal surface 28 of the proximal end 25 in the form of a flange 25. To induce rotational movement of the second movable component 16 by forcing the movable sleeve 15 to slide, in FIG. 18A-18E The sheath assembly incorporates a lever mechanism consisting of two opposing third limiting surfaces 40 positioned on two opposing arms 33 of the second movable assembly 16 and two opposing pivot protrusions 29 positioned on the movable sleeve 15. See also... FIG. 22-24 .

[0238] exist FIG. 18A-18E In this preferred embodiment of the sheath subassembly shown, the movable sleeve 15 is long such that the second movable component 16, while still in its initial position, protrudes in the proximal direction beyond the proximal edge 8 of the needle hub 1 and the proximal edge 22 of the mounting sleeve 14. Given the construction and, in particular, the dimensions of the arm 33 of the second movable component 6, the movable sleeve 15 travels a long distance in the proximal direction along the longitudinal axis X of the needle assembly between its initial and final positions during the coverage of the injection end 3.

[0239] In this preferred embodiment of the sheath subassembly shown in Figures 18A-18E, the movable sleeve 15, still in its initial position and therefore still in the initial position of the second movable component 16, forms, or together with the needle hub 1, a sheath for the non-injection end 5 of the needle. Furthermore, in a preferred embodiment of the first variant of the sheath subassembly, activation of the injection end sheath 31 causes simultaneous activation of the non-injection end sheath, and vice versa. In other words, in this preferred embodiment of the sheath subassembly, activation of either the injection end sheath 31 or the non-injection end sheath 5 by the user results in activation of the other of these sheaths. Simultaneously, the sheath for the non-injection end 5 formed by the movable sleeve 15 extends around the entire circumference of the groove exposed from the extension groove 7 of the needle hub 1.

[0240] In summary, the design aspects of a particular preferred embodiment of the first variant of the sheath subassembly of this application relate to the longitudinal dimensions of the immovable component 14, i.e., the mounting sleeve 14, the first movable component 15, i.e., the movable sleeve 15, and the second movable component 16, which cooperate with each other. It should be emphasized that, during the manufacturing process of this product, the structure of the sheath subassembly of this application allows for easy modification of the longitudinal dimensions of the components according to the customer's requirements for the safety requirements the product must meet. The possibility of changing its longitudinal dimensions, or in other words, the possibility of adjusting its longitudinal dimensions, provides an additional advantage to the needle assembly product of this application, namely, that a needle assembly product with the non-injection end 5 can be delivered that is more or less covered before and especially after the use of the needle assembly. Designing a sheath subassembly with well-covered needle non-injection end 5 even before the use of the needle assembly significantly reduces the possibility of the user being pricked by the non-injection end 5 when installing the needle assembly into the pen syringe 42. The design of a sheath subassembly with excellent coverage of the non-injection end 5 after use of the needle assembly significantly reduces the likelihood of the user being pricked by the non-injection end 5 when removing the needle assembly from the pen syringe 42 after injection and coverage of the injection end 3. Simultaneously, utilizing this simple structure of the sheath subassembly according to this application, the coverage of the non-injection end 5 is improved by employing respectively longer immovable component 14 and / or respectively longer first movable component 15, and / or by designing a needle assembly with a first movable component 15 that achieves a longer stroke during displacement from the initial position to the final position, without incurring excessive costs.

[0241] Considering the longitudinal dimensions of the mating components of the sheath subassembly, it should be understood that the aforementioned immovable component 14, the first movable component 15, and the second movable component 16 are structurally and dimensionally configured relative to each other. This mutual structural and dimensional configuration includes the longitudinal dimensions of the first movable component 15 and the immovable component 14, and the longitudinal dimensions a1 and a2 of the cross-section of the second movable component 16. This cross-section extends between the axis of rotation of the second movable component 16 (i.e., the vertical axis Y perpendicular to the longitudinal axis X of the needle assembly) and the distal surface 28 of the flange 25 of the first movable component 15 when the second movable component 16 is in its initial and final positions, respectively. The longitudinal dimensions a1 and a2 of the cross-section of the second movable component 16 are dimensions measured longitudinally along the longitudinal axis X of the needle assembly when the second movable component 16 is in its initial and final positions, respectively. FIG. 9E and 11E as well as FIG. 12E and 14E as well as FIG. 15B and 17BAs shown. These longitudinal dimensions are respectively adjusted to the position of the rotation axis of the second movable component 16 relative to the immovable component 14, that is, the position of the vertical axis Y relative to the needle seat 1.

[0242] Therefore, in the case of the non-removable component 14, it is preferable to install a sleeve 14 that protrudes beyond the needle hub 1 and / or beyond the first movable component 15 in the proximal direction. The movable sleeve 15, especially in its final position, provides better coverage of the non-injection end 5 of the needle, which is a safer coverage for the user. Before and after use of the needle assembly, the non-injection end 5 with the needle tip 6 is located deeper in the groove formed by the extended groove 7 of the needle hub 1, even in the preferred embodiment of the first variant of the needle assembly, where the first movable component 15 does not perform the function of covering the non-injection end 5, as shown in Figures 15-17.

[0243] Therefore, when the needle assembly having the immovable component 4 protrudes beyond the needle hub 1 and / or beyond the first movable component 15 in the proximal direction, the same immovable component 14 already acts as a cover for the non-injection end 5, regardless of whether the first movable component 15 also acts as a cover for the non-injection end 5. Simultaneously, the sheath of the non-injection end 5 provided by the immovable component 14 extends around the entire circumference of the groove formed by the extended groove 7 of the needle hub 1.

[0244] In a preferred embodiment of the sheath subassembly shown in Figures 9-11, 18, and 12-14, the first movable component 15, the second movable component 16, and the immovable component 14 are designed to be structurally and dimensionally configured relative to each other such that the first movable component 15 extends into the longitudinal dimension such that it extends proximally from its initial and final positions beyond the immovable component 14, at least in its final position, and in this way independently and / or together with the immovable component 14 and / or with the needle hub 1, forms the sheath of the non-injection end 5. The first movable component 15 extends the sheath of the non-injection end 5 proximally relative to the needle hub 1 and / or relative to the immovable component 14, at least in its final positions in its initial and final positions.

[0245] During the movement of the first movable component 15 and the second movable component 16 from their initial positions to their final positions, the injection end 3 is covered by the second movable component 16 coupled to the injection end sheath 31, and the non-injection end 5 is covered by the first movable component 15. The non-injection end 5 is covered by the first movable component 15 because the first movable component 15 moves in the proximal direction relative to the needle hub 1, the needle tube 2 is fixedly embedded in the needle hub 1, and further extends beyond the needle hub 1 until the final position of the first movable component 15, where the portion extends beyond the needle hub 1 to the greatest extent in the proximal direction.

[0246] During the movement of the first movable component 15 and the second movable component 16 from their initial positions to their final positions, the non-injection tip 6 of the needle non-injection end 5 gradually "relatively" penetrates into the groove that appears during the movement of the first movable component 15 and the second movable component 16 from the extension groove 7 of the needle seat 1 to the final position of the first movable component 15, wherein the non-injection tip 6 is recessed most deeply in the groove formed by the extension groove 7 of the needle seat 1.

[0247] Thus, the first movable component 15, at least in its final position, serves as a sheath for the non-injection end 5 of the needle, wherein the degree of coverage of the non-injection end 5 is based on the mutual configuration of the structure and dimensions of the first movable component 15, the immovable component 14, and the second movable component 16, and specifically, as described above, based on the longitudinal dimensions a1 and a2 of the aforementioned cross-sections of the first movable component 15, the immovable component 14, and the second movable component 16 when measured at its initial and final positions, respectively, as shown in Figures 9E and 11E. FIG. 12E and 14E as well as FIG. 15B and 17B As shown.

[0248] In a preferred embodiment of the first variant of the sheath subassembly shown in Figures 9-11, 12-14 and 18, the first movable component 15 independently forms a sheath for the non-injection end 5 at least in its final position, either in its initial or final position, and / or together with the immovable component 14 forms a sheath for the non-injection end 5.

[0249] In all preferred embodiments of the first variant of the sheath subassembly shown in the figure, at least one of the immovable component 14 and the first movable component 15 forms or together with the needle hub 1 to form a sheath for the non-injection end 5, the sheath for the non-injection end 5 extending around the entire circumference of the groove obtained by the extended groove 7 of the needle hub 1.

[0250] Furthermore, in a preferred embodiment of the first variant of the sheath subassembly shown in Figures 18 and 22-24, the injection end sheath 31 can be activated alternatively by forcing a rotational movement of the second movable component 16 or by forcing a sliding movement of the movable sleeve 15. Activation of either the injection end sheath 31 or the non-injection end sheath by the user will result in activation of the other of these sheaths.

[0251] As shown in this specification and Figures 9-11, 12-14, 15-17 and 18, the structure of the sheath sub-assembly and the needle assembly including the sheath sub-assembly of the first variant of this application significantly reduces the likelihood of injury to the user from the non-injection end 6 of the needle non-injection end 5, because at least in the initial and final positions of the first and second movable components 15 and 16, both the needle injection end 3 and the needle non-injection end 5 are covered, wherein the needle non-injection end 5 is covered not only by the needle hub 1 but also by the first movable component 15 and / or the non-movable component 14.

[0252] Therefore, in the manufacturing process of the needle assembly product with sheath sub-assembly according to this application, this structure allows for selection of the degree of coverage of the non-injection end 5 of the needle, respectively, according to the requirements of the ordering party or the user, especially after the needle assembly has been used. In particular, the selection of the longitudinal dimensions of the mating first movable component 15 and the second 16 can improve the coverage of the non-injection end 5 of the needle after the needle assembly has been used, thereby providing the user with a safer coverage. This is achieved through the simple structure of the sheath sub-assembly according to this application without incurring significantly higher costs.

[0253] The movable sleeve 15 is slidably mounted on the mounting sleeve 14 in the proximal direction along the longitudinal axis X of the needle assembly by means of a first mounting device, namely, in a preferred embodiment of the first variant of the sheath sub-assembly, two opposing longitudinal grooves 23 disposed on the movable sleeve 15 and two opposing longitudinal protrusions 21 disposed on the mounting sleeve 14. During its sliding movement, the movable sleeve 15 also engages with the mounting sleeve 14 by means of a first engaging device, namely, a longitudinal slit 24 disposed on the movable sleeve 15 and two opposing pivoting protrusions 18 with handles 19 disposed on the mounting sleeve 14.

[0254] The second movable component 16 is rotatably mounted on the mounting sleeve 14 about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly via a second mounting device. This second mounting device consists of two opposing shaped holes 34 and two opposing first tongues 35 disposed on two opposing arms 33 of the second movable component 16, and two opposing pivot protrusions 18 with handles 19 disposed on the mounting sleeve 14. To prevent the second movable component 16 from detaching from the mounting sleeve 14, a protective device is designed, namely, two opposing fixed discs 20 on the two opposing shaped holes 34 and two opposing first tongues 35 on the two opposing arms 33 of the second movable component 16, and on the two opposing handles 19 of the two opposing pivot protrusions 18 on the mounting sleeve 14.

[0255] In order to force the second movable component 16 to rotate, a rotatable abutment device is designed in the sheath subassembly. In a preferred embodiment of the first variant of the sheath subassembly, this is a rotatable abutment surface 32 on the second movable component 16.

[0256] The second movable component 16 engages with the mounting sleeve 14 during its rotational movement via a third engagement device, which is also two opposing shaped holes 34 and two opposing first tongues 35 disposed on the two opposing arms 33 of the second movable component 16, and two opposing pivot protrusions 18 with handles 19 disposed on the mounting sleeve 14. The second movable component 16 also engages with the movable sleeve 15 during its rotational movement via a second engagement device, which is two opposing first tongues 35, two opposing push surfaces 36 and two opposing second tongues 37 disposed on the two opposing arms 33 of the second movable component 16, and a distal surface 28 of the proximal end 25 in the form of a flange 25 disposed on the movable sleeve 15.

[0257] In order to hold the second movable component 16 and the movable sleeve 15 in their initial positions relative to the mounting sleeve 14, a first retaining device is designed in the sheath sub-assembly. The first retaining device consists of two opposing first limiting surfaces 30 and / or two opposing shaped holes 34 and / or two opposing first tongues 35 and / or two opposing curved pressing surfaces 36 and / or two opposing third limiting surfaces 40 disposed on two opposing arms 33 on the second movable component 16, and the distal end face 28 and / or two opposing pivot protrusions 29 disposed on the proximal end 25 of the movable sleeve 15, and two opposing pivot protrusions 18 disposed on the mounting sleeve 14 with two opposing handles 19.

[0258] In order to hold the second movable component 16 and the movable sleeve 15 in their final positions relative to the mounting sleeve 14, a second retaining device is designed in the sheath subassembly. The second retaining device consists of two opposing second limiting surfaces 39 and two opposing shaped holes 34 and / or two opposing third limiting surfaces 40 disposed on two opposing arms 33 on the second movable component 16, a distal end face 28 of the proximal end 25 disposed on the movable sleeve 15 and / or two opposing pivot protrusions 29, and two opposing pivot protrusions 18 having two opposing handles 19 disposed on the mounting sleeve 14.

[0259] In order to guide the sliding movement of the movable sleeve 15 on the mounting sleeve 14, a first guiding device is designed in the sheath sub-assembly, which consists of two opposing longitudinal grooves 23 disposed on the movable sleeve 15 and two opposing longitudinal protrusions 21 disposed on the mounting sleeve 14.

[0260] To guide the rotational movement of the second movable component 16 relative to the mounting sleeve 14 and on the movable sleeve 15, a second guiding device is designed in the sheath subassembly. This second guiding device consists of two opposing shaped holes 34, two opposing first tongues 35, two opposing push surfaces 36 and two opposing second tongues 37 disposed on two opposing arms 33 on the second movable component 16, two opposing pivot protrusions 18 with two opposing handles 19 disposed on the mounting sleeve 14, and a distal surface 28 of the proximal end 25 disposed on the movable sleeve 15.

[0261] Furthermore, in order to irreversibly block each other between the movable sleeve 15 and the second movable component 16 in their final positions, a locking device is designed in the sheath subassembly. This locking device consists of two opposing blocking holes 26 and a distal surface 28 disposed on the flange 25 of the movable sleeve 15, and two opposing first blocking surfaces 38 and two opposing second limiting surfaces 39 disposed on two opposing arms 33 of the second movable component 16.

[0262] By designing a first variant of the first mounting device and the second mounting device, the first, second and third engagement devices, the first and second guiding devices, and the first and second retaining devices in the sheath sub-assembly, which cooperate with each other, in all operating states and stages of the needle assembly with the sheath sub-assembly according to this application and respectively for correctly realizing all indicated functions of the specific technical means, the rotational movement of the second movable component 16 is limited to rotational movement about the vertical axis Y perpendicular to the longitudinal axis X of the needle assembly and from its initial position to its final position in the direction toward the injection end 3, and the sliding movement of the movable sleeve 15 is limited to movement in the proximal direction along the longitudinal axis X of the needle assembly and from its initial position to its final position, and is substantially impossible to move in the distal direction along the longitudinal axis X of the needle assembly.

[0263] Furthermore, by designing the same locking devices on the first movable component 15 and the second movable component 16 in the sheath subassembly, these locking devices are respectively structurally and dimensionally configured to irreversibly couple to each other when the first and second movable components 15 and 16 reach their final positions, the mobility of these first and second movable components 15 and 16 is irreversibly blocked and thus it is impossible to expose the needle injection end 3 again once it is covered, and preferably it is also impossible to pull out the needle non-injection end 5 again.

[0264] Figures 25-29 illustrate a medical needle injection system having a disposable sterile needle assembly and an active sheath subassembly for the needle injection end, in a preferred embodiment of a first variant shown substantially as in Figures 9-11 or 18, in a cross-sectional view along the longitudinal direction of the Z-plane of symmetry of the needle assembly, and in subsequent states and stages of operation of the needle injection system.

[0265] As shown in Figure 25, in order to seal the sterile needle assembly within the unit package 13 during manufacturing and attach it to the pen syringe 42 upon delivery to the user, the seal 12 needs to be removed from the unit package 13, and the protective cap (not shown) enclosing the assembly needs to be removed from the pen syringe 42. In this state, the needle assembly is arranged within the needle container 11, and the needle injection end 3 with endpoint 4 is within the outer needle shield 10. The needle assembly is attached to the body 43 of the pen syringe 42, as shown in Figure 26. The needle container 11 and the outer needle shield 10 only need to be removed from the needle hub 1 and the needle injection end 3 before the needle is inserted into the patient for injection.

[0266] The pen syringe 42 has a body 43 with external threads 44 at its distal end, away from the patient, to establish a threaded connection to the needle hub 1 of the needle assembly. In the preferred embodiment of all variations of the sheath subassembly according to this application, the external threads 44 on the body 43 of the pen syringe 42 and the internal threads 9 in the groove 7 of the needle hub 1 of the needle assembly serve as exemplary connection means for the pen syringe 42 with the needle hub 1 of the needle assembly. Inside the body 43 of the pen syringe 42, a primary package 45 containing a medicine 47, sealed with a diaphragm 46, is arranged. The diaphragm 46 is typically made of rubber material and ensures a tight seal of the sterile medicine 47. The primary package 45 may be a single-chamber or multi-chamber container. The needle assembly is mounted on the pen syringe 42 together with the sheath subassembly, establishing a threaded connection between the needle hub 1 and the body 43 of the pen syringe 42. During the stage of attaching the needle assembly to the pen syringe 42, i.e., screwing the needle assembly onto the syringe 42, the non-injection end 6 of the needle tube 2 penetrates the material of the diaphragm 46 wall of the primary packaging 45 and comes into contact with the sterile drug 47. After screwing the needle assembly onto the syringe 42, a portion of the length of the non-injection end 5 of the needle tube 2 with the needle end 6 is located within the primary packaging 45 when immersed in the drug 47. The non-injection end 5 is ready to deliver the drug 47 into the patient and is inaccessible to the user. After removing the needle container 11 from the needle assembly, removing the outer needle shield 10 from the needle injection end 3, and attaching the needle assembly to the body 43 of the pen syringe 42, the needle injection system is in a ready-to-injection state, as... FIG. 27 As shown.

[0267] After the needle tip 3 is inserted into the patient's body through the injection end 3 with the needle tip 4 and the injection is completed using a pen syringe 42 equipped with an activation mechanism and an injection device, the used injection needle tip 3 should be covered. Covering of the needle tip 3 occurs while the needle assembly remains mounted on the body 43 of the pen syringe 42, and is achieved by the method shown in Figures 19-21, i.e., by forcing the second movable component 16 to rotate, thereby causing the first movable component 15 to slide, or, in the case of the sheath subassembly in the preferred embodiment of the first variant shown in Figure 18, by... FIG. 22-24The method shown is implemented by forcing the first movable component 15 to slide, thereby causing the second movable component 16 to rotate. When the second movable component 16 and the first movable component 15 reach their final positions, the needle injection end 3 and the needle non-injection end 5 are irreversibly covered by the injection end sheath 31 contained in the second movable component 16 and this portion of the first movable component 15, respectively, which protrudes beyond the proximal edge 8 of the needle hub 1 and beyond the proximal edge 22 of the non-movable component 14. In a first variant embodiment of the sheath subassembly shown in Figures 25-29, the first movable component 15 forms the sheath of the non-injection end 5, particularly as... FIG. 28 The final position is shown. Accordingly, the needle injection end 3 with endpoint 4 and the needle non-injection end 5 with endpoint 6 are covered, and the first and second movable components 15 and 16 are locked in their final positions even before the needle assembly is separated from the pen syringe 42.

[0268] Only in this way can the needle assembly be safely unscrewed from the body 43 of the pen syringe 42. With the threaded connection between the needle assembly and the pen syringe 42 disconnected, as follows: FIG. 29 As shown, the first and second movable components 15 and 16 remain in an irreversible blocking state, so that both the needle injection end 3 and the needle non-injection end 5 remain in an irreversible covered state.

[0269] Despite FIG. 25-29 The present invention illustrates a medical needle-based injection system having a disposable sterile needle assembly and an active sheath subassembly for the needle injection end, in a preferred embodiment of the first variant substantially shown in Figures 9-11 or 18. However, the subsequent states and stages of operation of the needle-based injection system discussed are substantially similar and should be understood with reference to all other variants of the present invention, namely the second, third, fourth, and fifth variants of the sheath subassembly, and the characteristic technical features of the particular variants, namely the second, third, fourth, and fifth variants of the sheath subassembly.

[0270] When describing the operation of the needle assembly with sheath sub-assembly according to this application, the important advantage of this solution should be emphasized: despite its simple structure, it provides the user with a very convenient and safe grip when attaching and removing the needle assembly from the pen syringe 42, especially compared to more complex needle assembly solutions available on the market. For illustration, the needle assembly including the sheath sub-assembly is intended to be used in conjunction with the pen syringe 42 and the primary package 45 containing sterile medicine 47 to form a medical needle injection system. This system is a combination of a reusable device, namely the pen syringe 42, and a disposable device, namely the needle assembly. Operation of this system requires the user to repeatedly attach and detach the needle assemblies used, which are discarded in a medical waste container, while the pen syringe 42 is retained for subsequent injections. Attaching the needle assembly to the pen syringe 42 is safe because the needle assembly is in the needle container 11, and the injection end 3 is preferably additionally protected by an external needle shield 10 in the unit package 13. As described above, in the sheath subassembly according to this application, the non-injection end 5 can also be better covered by appropriately configuring the components of the sheath subassembly before attaching the needle assembly to the pen syringe 42. This configuration involves at least one of the immovable component 14 and the first movable component 15 protruding in the proximal direction beyond the proximal edge 8 of the needle hub 1 in the initial position of the first movable component 15. After attaching the needle assembly to the pen syringe 42, the protective components of the unit package 13 should be removed, leaving the sterile injection end 3 unprotected. After injection, the injection end 3 should be covered, and the needle assembly should be detached from the pen syringe 42 and then safely disposed of as medical waste.

[0271] According to this application, the injection end sheath 31 in the needle assembly is coupled to and / or included in the second movable component 16, and both are configured such that when the second movable component 16 is in its final position covering the injection end 3, it is convenient to grasp the second movable component 16 and manipulate it to unscrew the needle assembly from the pen syringe 42. The structure of the sheath sub-assembly according to this application and the design of the second movable component 16 coupled to the injection end sheath 31 provide an increased grip area that improves the grip of the needle assembly, prevents fingers from slipping off the needle hub 1, and significantly facilitates unscrewing the needle assembly from the pen syringe 42. In the needle assembly having the sheath sub-assembly according to this application, the injection end sheath 31, together with the second movable component 6 for covering the injection end 3, does not substantially achieve longitudinal movement along the longitudinal axis X, but rather changes position from a lateral or vertical position relative to the injection end 3 to a position above the injection end 3. The advantage of the needle assembly with a sheath sub-assembly according to this application distinguishes it from existing needle assemblies, in which the mechanism covering the injection end is designed to allow the injection end sheath to slide along the longitudinal axis X of the needle assembly and / or rotate about the longitudinal axis X of the needle assembly.

[0272] The structure of the needle assembly according to this application facilitates gripping and manipulating the needle assembly when it is in the needle container 11 of the unit package 13, in order to remove the protective seal 12 and mount the needle assembly onto the pen syringe 42. This is because, prior to use, the second movable component 16, which remains in its initial position, extends substantially perpendicular to the longitudinal axis X of the needle assembly, thereby expanding the gripping area of ​​the entire needle assembly within the needle container 11 and making it easier to grip.

[0273] Detailed supplementary description of a preferred embodiment of a second variation of the sheath sub-assembly according to this application Figures 30-31 illustrate a needle assembly with a sheath sub-assembly according to a second variant of this application, in a subsequent state and stage after the needle assembly is ready to perform an injection operation, i.e., after the protective component of the unit package 13 is removed from the needle assembly. FIG. 1-3 The needle container 11, the outer needle guard 10 for the needle injection end 3, and the seal 12 are shown. Correspondingly, FIG. 30A-30D A needle assembly having a second movable component 16 and a movable sleeve 15 in their initial position is shown, and FIG. 31A-31D A needle assembly having a second movable component 16 and a movable sleeve 15 in their final position is shown. The needle assembly is mounted on a pen syringe 42.

[0274] The needle hub 1, applied in the second variant of the sheath subassembly, is as follows: FIG. 3 As shown and as described above.

[0275] Mounting sleeve 14 essentially possesses the basic technical features of mounting sleeve 14 shown in Figures 4A and 4B, but excluding the opposing longitudinal protrusions 21 and longitudinal grooves 23, and additionally features a second variant of the sheath subassembly, namely two opposing resilient engagement protrusions 48 at its distal end, each resilient engagement protrusion 48 having a first limiting surface 49, a guiding surface 50 and a second limiting surface 51, and two opposing retaining protrusions 54. Mounting sleeve 14 is immovably mounted on needle hub 1 and extends substantially axially along needle hub 1, its longitudinal dimension such that, in the proximal direction, its proximal edge 22 does not protrude beyond the proximal edge 8 of needle hub 1, thus not forming or not forming with needle hub 1 a sheath for the non-injection end 5.

[0276] However, it should be understood that an advantageous embodiment of a second variation of the sheath subassembly can be designed, wherein the mounting sleeve 14 will protrude beyond the proximal edge 8 of the needle hub 1, and thus will form, or also together with, a sheath for the non-injection end 5 of the needle hub 1, both in the initial and final positions of the movable sleeve 15, and consequently, both in the initial and final positions of the second movable component 16. This design will allow for better coverage of the non-injection end 5 of the needle, which is safer for the user than the coverage shown in Figures 30-31, because the non-injection end 6 of the needle non-injection end 5 will be located deeper within the groove obtained from the extended groove 7 of the needle hub 1. This coverage of the non-injection end 5 of the needle by the long mounting sleeve 14 will extend around the entire circumference of the groove formed by the extended groove 7 of the needle hub 1. In this preferred embodiment of the second variant of the sheath subassembly, the non-injection end 5 of the needle, in addition to being covered by the needle hub 1, is covered by the mounting sleeve 14 and is already covered before the use of the needle assembly, and is covered by the movable sleeve 15 in its final position. Therefore, the long mounting sleeve 14 serves independently as a sheath for the non-injection end 5 before and after the use of the needle assembly.

[0277] The movable sleeve 15 is designed as a substantially incomplete cylindrical clamp and is rotatably mounted on two opposing pivot protrusions 18 of the mounting sleeve 14 between its initial and final positions via two opposing arms extending from this clamp, each terminating with a specially constructed gripping portion. In the final position, the movable sleeve 15 partially surrounds the body 43 of the pen syringe 42 with its incomplete clamping, thereby forming a sheath for the non-injection end 5 of the needle. The movable sleeve 15 and the sheath of the non-injection end 5 are made of the same homogeneous material as a single structural component and integrally constitute a single component of the sheath subassembly.

[0278] The arms of the movable sleeve 15 are preferably made of plastic elastic arms. The aforementioned mounting device of the movable sleeve 15 on the mounting sleeve 14 constitutes an exemplary first mounting device in this embodiment of a preferred second variation applied to the sheath subassembly. The movable sleeve 15 is prevented from slipping off the mounting sleeve 14 by a first protective device, which consists of two opposing shaped holes and two opposing grips disposed on two opposing arms of the movable sleeve 15, and two opposing retaining discs 20 disposed on two opposing handles 19 of two opposing pivot protrusions 18 on the mounting sleeve 14.

[0279] The immovable component 14, preferably the mounting sleeve 14, and the first movable component 15, preferably the movable sleeve 15, are configured in structure and size to each other such that the movable sleeve 15 extends longitudinally along the longitudinal axis X of the needle assembly in its final position to such a size that, in the proximal direction, it protrudes beyond the needle hub 1 and beyond the mounting sleeve 14, thereby forming a sheath for the non-injection end 5 of the needle after the injection end sheath 31 is activated and after the injection end 3 of the needle is covered.

[0280] Regarding design considerations for the second variant of the sheath subassembly according to this application, which relate to the longitudinal dimensions of the mating immovable component 14, i.e., the mounting sleeve 14, and the first movable component 15, i.e., the movable sleeve 15, the second variant of the sheath subassembly, particularly concerning the immovable component 14, especially the possibility of changing its longitudinal dimension, or in other words, the possibility of selecting its longitudinal dimension, should be understood similarly to that described above for the preferred embodiment of the first variant of the sheath subassembly, and should be applied accordingly to the preferred embodiment of the second variant in conjunction with the technical features of the second variant. In particular, it should be noted that the structural and dimensional configuration of the first movable component 15 and the immovable component 14 mutually encompasses the longitudinal dimensions of these components, wherein the longitudinal dimension of the first movable component 15 is the dimension of the component measured when the component is in its final position.

[0281] The second movable component 16 has in its external portion FIG. 6A-6C The technical features of the second movable component 16, which are basically shown in Figures 9-11, 12-14, 15-17, and 18, are that this part includes an injection end sheath 31 and two opposing arms 33 extending from the injection end sheath 31. Furthermore, the second movable component 16 has the technical means of a second variation of the sheath sub-assembly, where each arm 33 terminates with a gripping portion of a special construction having shaped holes. The second movable component 16 and the injection end sheath 31 are manufactured together as a single integral structure made of the same homogeneous material.

[0282] The movable sleeve 15 and the second movable component 16 are rotatably mounted on the mounting sleeve 14 relative to the vertical axis Y, wherein the vertical axis Y is perpendicular to the longitudinal axis X of the needle assembly, and engage with the mounting sleeve 14 during rotational movement via two opposing engaging joints, preferably resilient engaging joints, which are disposed between each arm of the movable sleeve 15 and between each arm 33 of the second movable component 16, and gripping portions with shaped holes are applied to each arm of the movable sleeve 15 and each arm 33 of the second movable component 16.

[0283] Specifically, to rotatably mount the second movable component 16 onto the mounting sleeve 14 about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, a second mounting device is designed, which consists of two opposing shaped holes and two gripping portions on the two opposing arms 33 of the second movable component 16, and two opposing pivoting protrusions 18 with handles 19 on the mounting sleeve 14. To engage the movable sleeve 15 during its rotational movement relative to the mounting sleeve 14, a first mounting device is designed, which consists of two opposing shaped holes and two opposing gripping portions on the two opposing arms of the movable sleeve 15, and two opposing pivoting protrusions 18 with handles 19 on the mounting sleeve 14. To engage the movable sleeve 15 with the second movable component 16, a second engagement device is designed, which consists of two opposing engaging joints between the two opposing arms 33 of the movable sleeve 15 and the second movable component 16. To enable the second movable component 16 to engage during its rotational movement relative to the mounting sleeve 14, a third engagement device is designed, which consists of two opposing shaped holes and two opposing grips on the two opposing arms 33 of the second movable component 16.

[0284] Similar to the movable sleeve 15, the second movable component 16 is also prevented from slipping off the mounting sleeve 14 by a second protective device, which consists of two opposing shaped holes and two opposing grips disposed on two opposing arms 33 of the second movable component 16, and two opposing retaining discs 20 disposed on two opposing handles 19 of two opposing pivot protrusions 18 on the mounting sleeve 14.

[0285] To guide the rotational movement of the movable sleeve 15 relative to the mounting sleeve 14 about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, a first guiding device is designed. This first guiding device comprises two opposing shaped holes, two opposing grips, and two opposing arms on the movable sleeve 15, as well as two opposing pivot protrusions 18 having two opposing handles 19, and two opposing guide surfaces 50 on the two opposing engagement protrusions 48 of the mounting sleeve 14. During the movement of the movable sleeve 15 from its initial position to its final position, the appropriate elastic arms of the movable sleeve 15 "pass" through the guide surfaces 50 of the appropriate elastic engagement protrusions 48 of the mounting sleeve 14, and subsequently become locked relative to the second limiting surface 51 of the mounting sleeve 14 by their second blocking surface 53.

[0286] To guide the rotational movement of the second movable component 16 relative to the mounting sleeve 14 about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, a second guiding device is designed, which consists of two opposing shaped holes and two opposing grips on the two opposing arms 33 of the second movable component 16, and two opposing pivot protrusions 18 with handles 19 on the mounting sleeve 14.

[0287] In order to hold the second movable component 16 and the movable sleeve 15 relative to the mounting sleeve 14 in their initial positions, a first retaining device is designed in the sheath subassembly. In a preferred embodiment of the second variant of the sheath subassembly, the first retaining device consists of two opposing arms 33 of the second movable component 16 and two opposing first blocking surfaces 52 on the two opposing arms of the movable sleeve 15, and two opposing pivot protrusions 18, two opposing engagement protrusions 48, two opposing first limiting surfaces 49, and two opposing retaining protrusions 54 on the mounting sleeve 14.

[0288] In order to hold the second movable component 16 and the movable sleeve 15 in their final positions relative to the mounting sleeve 14, a second retaining device is designed in the sheath subassembly. In a preferred embodiment of the second variant of the sheath subassembly, the second retaining device consists of two opposing second blocking surfaces 53 on the two opposing arms of the movable sleeve 15 and two opposing second limiting surfaces 51 on the mounting sleeve 14, which have two opposing pivot protrusions 18 and two opposing engagement protrusions 48.

[0289] The movable sleeve 15 and the second movable component 16 are movable between their initial and final positions. In the initial position, they extend substantially perpendicular to the longitudinal axis X of the needle assembly, and in the final position, they extend substantially longitudinally along the longitudinal axis X of the needle assembly. The second movable component 16 is fixedly and non-removably coupled to the injection end sheath 31 and integrally forms a single component of the sheath sub-assembly made of the same homogeneous material. In the initial position of the movable sleeve 15 and the second movable component 16, the injection end 3 is not covered, and in the final position of the movable sleeve 15 and the second movable component 16, the injection end 3 is covered. In a second variation of the sheath subassembly according to this application, the mounting sleeve 14, the movable sleeve 15, and the second movable component 16 are configured to cooperate with each other, and the movable sleeve 15 and the second movable component 16 engage with each other in motion, such that the activation of the injection end sheath 31 is achieved by forcing a rotational movement of either the movable sleeve 15 or the second movable component 16 to cause the other to move between the initial and final positions of each of the aforementioned movable components, namely the second movable component 16 and the movable sleeve 15.

[0290] The method of activating the needle injection tip sheath 31 by forcing the second movable component 16 to rotate about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly and toward the needle injection tip 3 is basically the same as... FIG. 19 - The method for the sheath subassembly in the first variant shown in -21 is the same. To cover the needle injection end 3, when the body 43 of the pen syringe 42 is held, the user presses the second movable component 16 against any hard surface, such as a table or tray, via the rotatable abutment surface 32, forcing the second movable component 16, along with its included injection end sheath 31, toward the injection end 3 having the needle tip 4. Upon rotation, the second movable component 16 causes the movable sleeve 15 to rotate about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly and toward the non-injection end 5 of the needle.

[0291] The method of activating the needle injection end sheath 31 by forcing the movable sleeve 15 to rotate about the vertical axis Y perpendicular to the longitudinal axis X of the needle assembly and toward the non-injection end 5 of the needle is essentially similar to the method of forcing the second movable component 16 to rotate as described above, except that the needle injection system needs to be properly placed on a hard surface.

[0292] In a second variation of the sheath subassembly according to this application, activation of the injection end sheath 31 can also be alternatively achieved by forcing the movable sleeve 15 to rotate, thereby causing the second movable component 16 to rotate. For this purpose, when holding the body 43 of the pen syringe 42, the user presses the movable sleeve 15 against any hard surface, such as a table or tray, via its rotatable abutment surface 55, forcing the movable sleeve 15 and the protective element of the non-injection end 5 included therein to rotate toward the non-injection end 5 having the needle tip 6. Upon rotation, the movable sleeve 15 causes the second movable component 16 to rotate about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly and toward the needle injection end 3.

[0293] During the rotational movement of the first and second movable components 15 and 16 from their initial positions to their final positions, both the second movable component 16 covers the injection end 3 and the first movable component 15 covers the non-injection end 5. The first movable component 15 covers the non-injection end 5 because the first movable component 15 rotates toward the longitudinal axis X of the needle assembly, such that during this rotation, it gradually extends beyond the needle hub 1 in the proximal direction along the longitudinal direction of the longitudinal axis X of the needle assembly until its final position, in which it protrudes most far beyond the needle hub 1 in the proximal direction.

[0294] In a second variation of the sheath subassembly according to this application, rotational movement of one of the first movable component 15 and the second movable component 16, activated by the user, causes rotational movement of the other, occurring between their respective initial and final positions. In other words, activation of rotational movement of either the first or second movable component 15 and 16 simultaneously activates rotational movement of the other. For the same reason, rotational movement of either the first or second movable component 15 and 16 activates the injection end sheath 31 and the non-injection end sheath 5. In other words, in the second variation of the sheath subassembly, user activation of either the needle injection end sheath 31 or the non-injection end sheath 5 activates the other of these sheaths.

[0295] In a second variation of the sheath subassembly, the first and second movable components 15 and 16 are respectively configured on opposite sides of their respective axes of rotation, defined by the vertical axis Y, such that they are kinetically engaged with each other to form a mechanical first-order lever about their common axis of rotation.

[0296] In order to force the first movable component 15, preferably the movable sleeve 15, and the second movable component 16, to rotate about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, and in order to move these components from their initial positions to their final positions, in a second variant of the sheath subassembly, the first rotatable abutment is designed in the form of a rotatable abutment surface 55 on the movable sleeve 15, and the second rotatable abutment is designed in the form of a rotatable abutment surface 32 on the second movable component 16.

[0297] Furthermore, in order to irreversibly block the movable sleeve 15 and the second movable component 16 in their final positions with respect to the immovable sleeve 14, a locking device is designed in the sheath subassembly. In the preferred embodiment of the second variant of the sheath subassembly, the locking device consists of two opposing second blocking surfaces 53 on the two opposing arms of the movable sleeve 15 and two opposing second limiting surfaces 51 on the two opposing engaging protrusions 48 of the immovable sleeve 14.

[0298] By incorporating a second variation of the first and second mounting devices, first and second and third engagement devices, first and second guiding devices, and first and second retaining devices in the sheath subassembly, they respectively cooperate with each other in all states and stages of operation of the needle assembly with the sheath subassembly according to this application and are respectively used to correctly realize all indicated functions of the specific technical device. The rotational movement of the first movable component 15 is limited to rotational movement about the vertical axis Y perpendicular to the longitudinal axis X of the needle assembly and from its initial position to its final position in the direction toward the non-injection end 5, and the rotational movement of the second movable component 16 is limited to rotational movement about the vertical axis Y perpendicular to the longitudinal axis X of the needle assembly and from its initial position to its final position in the direction toward the injection end 3.

[0299] Furthermore, by designing the same locking devices on the first movable component 15 and the immovable component 14 in the sheath subassembly, these locking devices are respectively configured and sized to be irreversibly coupled to each other when the first and second movable components 15 and 16 reach their final positions, the mobility of these first and second movable components 15 and 16 is irreversibly prevented, so that once the needle injection end 3 and the needle non-injection end 5 are covered, it is impossible to expose them again.

[0300] The above description, in conjunction with Figures 4A, 4B and 6A-6C, shows and describes the technical features of the immovable component 14 in the form of an mounting sleeve 14 and the technical features of the second movable component 16, as well as the technical functions assigned to them in relation to a specific variant of the sheath subassembly according to this application. Reference should be made to the second variant of the sheath subassembly, and the technical features specific to the second variant should be understood.

[0301] Detailed supplementary description of the third variation of the sheath sub-assembly according to this application in its preferred embodiment Figures 32-34 illustrate a needle assembly with a sheath sub-assembly in a preferred embodiment of a third variant according to this application, wherein the needle hub 1 used in this embodiment is as follows: FIG. 3 Combined with the above FIG. 3 The following description is provided: the immovable component 14 in the form of an mounting sleeve 14 used in this embodiment is shown in Figures 4A-4B and described above in conjunction with Figures 4A-4B; the first movable component 15 in the form of a movable sleeve 15 used in this embodiment is shown in Figures 5C-5D and described above in conjunction with Figures 5C-5D; and the second movable component 16 used in this embodiment is shown in Figures 6D-6E and described above in conjunction with Figures 6D-6E.

[0302] As shown in Figures 32-34, in a preferred embodiment of the third variant, the sheath subassembly includes a mounting sleeve 14 immovably mounted on the needle hub 1 and extending substantially longitudinally along the longitudinal axis X of the needle assembly; a movable sleeve 15 mounted on the mounting sleeve 14, which is slidably slidably longitudinally along the needle longitudinal axis X in the proximal direction; and a second movable component 16 slidably mounted on the mounting sleeve 14, which is perpendicular to the longitudinal axis X and substantially oriented in the direction of the longitudinal axis X.

[0303] The movable sleeve 15 and the second movable component 16 are movable between their initial and final positions, wherein the movable sleeve 15 extends substantially longitudinally along the longitudinal axis X of the needle assembly, while the second movable component 16 extends substantially perpendicularly to the longitudinal axis X.

[0304] In the preferred embodiment of the third variant shown in Figures 32-34, a mounting sleeve 14 is employed, the proximal edge 22 of which does not protrude in the proximal direction beyond the proximal edge 8 of the needle hub 1, thus not forming a sheath for the non-injection end 5, or not forming a sheath for the non-injection end 5 together with the needle hub 1. However, it should be understood that a preferred embodiment of the third variant of the sheath subassembly can be designed in which the mounting sleeve 14 protrudes beyond the proximal edge 8 of the needle hub 1, thereby forming a sheath for the non-injection end 5, or also forming a sheath for the non-injection end 5 together with the needle hub 1, whether in the initial or final position of the second movable component 16. The mounting sleeve 14 may also protrude in the proximal direction beyond the movable sleeve 15, at least in the initial position of the movable sleeve 15, and then the same mounting sleeve 14 will independently serve as a sheath for the non-injection end 5, at least in the initial position of the movable sleeve 15, and regardless of whether the movable sleeve 15 itself serves as a sheath for the non-injection end 5, at least in its final position. The sheath of the non-injection end 5 formed by the mounting sleeve 14 extends around the entire circumference of the groove formed by the extended groove 7 of the needle seat 1.

[0305] In the preferred embodiment of the third variant shown in Figures 32-34, a movable sleeve 15 is employed, which protrudes in the proximal direction in its final position, with its proximal end 25 extending beyond the proximal edge 8 of the needle hub 1. Thus, the movable sleeve 15 forms, or also forms with the needle hub 1, a sheath for the non-injection end 5 in its final position, thereby also forming a sheath for the second movable component 16 in its final position. However, it should be understood that a preferred embodiment of the third variant of the sheath subassembly can be designed where the movable sleeve 15 will protrude beyond the proximal edge 8 of the needle hub 1 in its initial position and / or, during the covering of the injection end 3, will achieve a very long travel along the longitudinal axis X of the needle assembly in the proximal direction between its initial and final positions, which will allow for a covering of the non-injection end 5 even greater than shown in Figures 32-34. It should be understood that the degree of covering of the non-injection end 5 of the needle before and after use of the needle assembly depends on the mutual configuration of the structure and dimensions of the mating components of the sheath subassembly and appropriate adjustments in this regard during the manufacturing process of the needle assembly product. According to this application, the orderer or user of the needle assembly product with sheath sub-assembly has the opportunity to influence the selection of the degree of coverage of the non-injection end 5 of the needle.

[0306] Regarding the design considerations of the sheath subassembly according to this application, it relates to the longitudinal dimensions of the mating immovable component 14, i.e., the mounting sleeve 14, and the first movable component 15, i.e., the movable sleeve 15, particularly the possibility of changing their longitudinal dimensions, or in other words, the possibility of adjusting their longitudinal dimensions. These have been described above for the preferred embodiment of the first variant of the sheath subassembly. The preferred embodiment of the third variant should be similarly understood and appropriately applied upon understanding the technical features of the third variant. In particular, it should be noted that in the third variant of the sheath subassembly, the longitudinal dimension of the second movable component 16 is also selected, particularly in its portion constituting the clamp, and the longitudinal dimension of the movable sleeve 15 is selected relative to the longitudinal dimensions of the needle hub 1 and the mounting sleeve 14, respectively, for mating with the second movable component 16. This is important for covering the non-injection end 5 after using the needle assembly.

[0307] The second movable component 16, located distal to the needle assembly, includes a sheath for the injection end 31, which is rotatably coupled about a vertical axis Y1 perpendicular to and spaced from the longitudinal axis X of the needle assembly. The second movable component 16 and the sheath together form a single component of a sheath assembly made of the same homogeneous material. In the initial positions of the movable sleeve 15 and the second movable component 16, the injection end sheath 31 extends substantially vertically about the longitudinal axis X of the needle assembly, and the injection end 3 is not covered. In the final positions of the movable sleeve 15 and the second movable component 16, the injection end sheath 31 extends substantially longitudinally about the longitudinal axis X, and the injection end 3 is covered.

[0308] As the second movable component 16 moves perpendicularly to and substantially toward the longitudinal axis X, the injection end sheath 31 moves in the same direction and is guided on the movable sleeve 15, causing it to rotate about the second movable component 16 and approach and rise above the injection end 3, so that in the final position of the second movable component 16 it forms the sheath of the injection end 3.

[0309] The injection end sleeve 31 moves relative to the immovable mounting sleeve 14 and to the needle hub 1 and further to the needle injection end 3, resulting in a linear motion caused by the superposition of the sliding motion of the second movable component 16 and the rotational motion of the injection end sleeve 31 relative to the second movable component 16.

[0310] In a third variation of the sheath subassembly according to this application, the mounting sleeve 14, the movable sleeve 15, and the second movable component 16 are configured to cooperate with each other, and the movable sleeve 15 and the second movable component 16 are kinetically engaged with each other such that activation of the injection end sheath 31 is achieved by forcing the sliding movement of the second movable component 16, thereby causing the movable sleeve 15 to slide between the initial and final positions of these movable components, i.e., each of the second movable component 16 and the movable sleeve 15 respectively.

[0311] In order to force the second movable component 16 to slide vertically and substantially toward the longitudinal axis X of the needle assembly, and in order to move the second movable component 16 from its initial position to its final position, a sliding abutment device is designed in the sheath subassembly, which is a sliding abutment surface 67 on the second movable component 16.

[0312] In order to slidably mount the movable sleeve 15 on the mounting sleeve 14 in the proximal direction along the longitudinal axis X of the needle assembly, and in order to guide the movable sleeve 15 to slide on the mounting sleeve 14, a first mounting device and a first guiding device are designed in the sheath sub-assembly, which are two opposing longitudinal grooves 23 on the movable sleeve 15 and two opposing longitudinal protrusions 21 on the mounting sleeve 14.

[0313] To allow the second movable component 16 to be slidably mounted on the mounting sleeve 14 about the longitudinal axis X of the needle assembly, substantially in a direction toward the longitudinal axis X, a second mounting device is designed in the sheath subassembly. This second mounting device consists of two opposing coupling slots 56 on the two opposing arms 33 of the second movable component 16 and two opposing pivot protrusions 18 with handles 19 on the mounting sleeve 14. In a preferred embodiment of a third variation of the sheath subassembly, the coupling slots 56 are linear in shape.

[0314] The second movable component 16 is protected from slipping off the mounting sleeve 14 by means of two opposing coupling slots 56 on two opposing arms 33 of the second movable component 16 and two opposing retaining discs 20 on two opposing handles 19 of two opposing pivot protrusions 18 on the mounting sleeve 14.

[0315] In order for the movable sleeve 15 to engage with the mounting sleeve 14 during its sliding movement, a first engagement device is designed in the sheath sub-assembly, namely two opposing longitudinal cutouts 24 on the movable sleeve 15 and two opposing pivot protrusions 18 with handles 19 on the mounting sleeve 14.

[0316] To enable the second movable component 16 to engage with the movable sleeve 15 during its sliding movement, a second engagement mechanism is designed in the sheath subassembly. This second engagement mechanism consists of two opposing fourth limiting surfaces 58 and two opposing push surfaces 59 on the two opposing arms 33 of the second movable component 16, and two opposing guide surfaces 63 on the two opposing proximal protrusions 62 on the movable sleeve 15. The proximal surface of each arm 33 of the second movable component 16 is zigzag-shaped, with each segment from one end of the arm 33 that together forms a clamp to the other end being, in sequence, a fifth limiting surface 61, a second blocking surface 60, a push surface 59, and a fourth limiting surface 58.

[0317] In order to engage the second movable component 16 with the mounting sleeve 14 during its sliding movement, a third engagement device is designed in the sheath subassembly, namely two opposing coupling slots 56 on the two opposing arms 33 of the second movable component 16 and two opposing pivot protrusions 18 with handles 19 on the mounting sleeve 14.

[0318] In order to engage the injection end sheath 31 with the movable sleeve 15 during movement, a fourth engagement device is designed in the sheath sub-assembly, namely two opposing bending surfaces 66 on the injection end sheath 31 and the distal surface 65 on the movable sleeve 15.

[0319] To guide the sliding movement of the second movable component 16 about the mounting sleeve 14 and the movable sleeve 15, which is perpendicular to and substantially oriented towards the longitudinal axis X of the needle assembly, a second guiding device is designed in the sheath subassembly. This second guiding device consists of two opposing coupling slots 56, two opposing fourth limiting surfaces 58, and two opposing straight-push surfaces 59 on the two opposing arms 33 of the second movable component 16; two opposing guide surfaces 63 on the two opposing proximal protrusions 62 on the movable sleeve 15; and two opposing pivot protrusions 18 and two opposing handles 19 on the mounting sleeve 14. In a preferred embodiment of a third variation of the sheath subassembly, the coupling slots 56 with proximal surfaces 57 are linear in shape.

[0320] To guide the rotational movement of the injection end sheath 31 on the movable sleeve 15 about the vertical axis Y1, which is perpendicular to and at a distance from the longitudinal axis X of the needle assembly, a third guiding device is designed in the sheath assembly. These are two opposing curved push surfaces 66 and the distal surface 65 on the injection end sheath 31 and the movable sleeve 15.

[0321] During the movement of the second movable component 16 and the movable sleeve 15 from their initial positions to their final positions, the injection end 3 is enveloped by an injection end sheath 31 rotatably coupled to the second movable component 16, and the non-injection end 5 is enveloped by the movable sleeve 15. The envelope of the non-injection end 5 by the movable sleeve 15 is due to the proximal movement of the movable sleeve 15 relative to the needle hub 1, in which the needle tube 2 is fixedly embedded, and the movable sleeve 15 further extends beyond the proximal edge 8 of the needle hub 1 until its final position, where the movable sleeve 15 protrudes most far from the needle hub 1 in the proximal direction. The sheath of the non-injection end 5 created by the movable sleeve 15 in its final position extends around the entire circumference of the groove obtained by the extended groove 7 of the needle hub 1.

[0322] The shape of the coupling slot 56 and the shape of the proximal surface of the arm 33 of the second movable component 16 are structurally and dimensionally configured to fit together and to fit with the remaining structural elements of the second movable component 16 and the remaining components of the needle assembly, so as to achieve effective and safe coverage of the needle injection end 3 in the needle assembly with sheath sub-assembly in the third variant.

[0323] In the preferred embodiment of the third variant shown in Figures 32-34, the injection end sheath 31 is activated by forcing the sliding movement of the second movable component 16, which causes the sliding movement of the movable sleeve 15. This simultaneously activates the sheath of the non-injection end 5, which is formed by the movable sleeve 15 in its final position.

[0324] In order to hold the movable sleeve 15 and the second movable component 16 in their initial positions relative to the mounting sleeve 14, a first retaining device is designed in the sheath subassembly. The first retaining device consists of two opposing pivot protrusions 18 on the mounting sleeve 14 having two opposing handles 19, two opposing guide surfaces 63 on two opposing proximal protrusions 62 on the movable sleeve 15, and two opposing coupling slots 56 and two opposing fourth limiting surfaces 58 on two opposing arms 33 of the second movable component 16.

[0325] In order to hold the movable sleeve 15 and the second movable component 16 in their final position relative to the mounting sleeve 14, a second retaining device is designed in the sheath subassembly. The second retaining device consists of two opposing pivot protrusions 18 on the mounting sleeve 14 having two opposing handles 19, two opposing guide surfaces 63 on the two opposing proximal protrusions 62 of the movable sleeve 15, and two opposing coupling slots 56 and two opposing fifth limiting surfaces 61 on the two opposing arms 33 of the second movable component 16.

[0326] Furthermore, in order to irreversibly block the movable sleeve 15 and the second movable component 16 from each other in their final positions, a locking device is designed in the sheath assembly. This locking device consists of two opposing blocking surfaces 64 and two opposing guiding surfaces 63 on two opposing proximal protrusions 62 on the movable sleeve 15, and two opposing second blocking surfaces 60 and two opposing fifth limiting surfaces 61 on two opposing arms 33 of the second movable component 16.

[0327] The method of activating the needle injection end sheath 31 by forcing the second movable component 16 to slide about a vertical axis Y1 perpendicular to the longitudinal axis X of the needle assembly and substantially toward the needle injection end 3 is substantially the same as the method of the sheath sub-assembly in the first variant shown in Figures 19-21. To cover the needle injection end 3, when the body 43 of the pen syringe 42 is held, the user presses the second movable component 16 against any hard surface, such as a table or tray, via the slidable abutment surface 67, forcing the second movable component 16, together with the included injection end sheath 31, to move from its initial position to its final position in the direction toward the injection end 3 with the needle tip 4. During sliding, the second movable component 16 causes the movable sleeve 15 to move from its initial position to its final position longitudinally along the longitudinal axis X of the needle assembly and in the direction toward the non-injection end 5 of the needle.

[0328] By designing a third variation of the first and second mounting devices according to the aforementioned first and second mounting devices in the sheath subassembly, the first, second and third engagement devices, the first and second guide devices and the first and second retaining devices respectively cooperate with each other in all states and stages of operation of the needle assembly with the sheath subassembly according to this application and are respectively used to correctly realize all indicated functions of the specific technical device, the sliding movement of the second movable component 16 is limited to movement from its initial position to its final position in a direction perpendicular to the longitudinal axis X of the needle assembly and substantially in the direction of the longitudinal axis X, and the sliding movement of the movable sleeve 15 is limited to movement in the proximal direction along the longitudinal axis X of the needle assembly and from its initial position to its final position and is substantially impossible to move in the proximal direction along the longitudinal axis X.

[0329] Furthermore, by designing locking devices on the movable sleeve 15 and the second movable component 16 in the sheath subassembly, which are structurally and dimensionally configured to irreversibly couple with each other when the movable sleeve 15 and the second movable component 16 reach their final positions, the mobility of the movable sleeve 15 and the second movable component 16 is irreversibly prevented, so that once the needle injection end 3 is covered, it cannot be exposed again, and preferably the non-injection end 5 of the needle is also covered.

[0330] Detailed supplementary description of the fourth variation of the sheath sub-assembly according to this application in its preferred embodiment Figures 35-37 illustrate a needle assembly with a sheath sub-assembly according to a preferred embodiment of a fourth variant of this application, wherein the needle hub 1 used in this embodiment is as shown in Figure 3 and is related to Figure 3 as described above; the immovable component 14 in the form of a mounting sleeve 14 used in this embodiment is as shown in Figures 4A-4B and is related to Figures 4A-4B as described above; the first movable component 15 in the form of a movable sleeve 15 used in this embodiment is as shown in Figures 5C-5D and is related to Figures 5C-5D as described above; and the second movable component 16 used in this embodiment is as shown in Figures 6F-6G and is related to Figures 6F-6G as described above.

[0331] As shown in Figures 35-37, in a preferred embodiment of the fourth variant, the sheath subassembly includes: a mounting sleeve 14, which is immovably mounted on the needle hub 1 and extends substantially longitudinally along the longitudinal axis X of the needle assembly; a movable sleeve 15, the proximal end of which is slidably mounted on the mounting sleeve 14 along the longitudinal axis X; and a second movable component 16, which is perpendicular to the longitudinal axis X and slidably mounted on the mounting sleeve 14 substantially in a direction toward the longitudinal axis X. The second movable component 16 is non-detachably fixedly connected to the injection end sheath 31 and integrally forms a single component of the needle subassembly made of the same homogeneous material.

[0332] The movable sleeve 15 and the second movable component 16 move between their initial and final positions, wherein the movable sleeve 15 extends substantially longitudinally along the longitudinal axis X of the needle assembly, while the second movable component 16 extends substantially perpendicular to the longitudinal axis X.

[0333] In the preferred embodiment of the fourth variant shown in Figures 35-37, an installation sleeve 14 is used, the proximal edge 22 of which does not protrude in the proximal direction of the proximal edge 8 of the needle seat 1. Therefore, it does not form a sheath for the non-injection end 5, or does not form a sheath for the non-injection end 5 together with the needle seat 1.

[0334] In the preferred embodiment of the fourth variant shown in Figures 35-37, a movable sleeve 15 is applied, in which, in its final position, its proximal end 25 protrudes in the proximal direction beyond the proximal edge 8 of the needle hub 1. Thus, the movable sleeve 15 forms, or also forms together with the needle hub 1, a sheath for the non-injection end 5 in its final position, thereby also forming the final position of the second movable component 16.

[0335] However, similar to what is mentioned in the detailed supplementary description of the preferred embodiment of the third variation shown in Figures 32-34, it should be understood that a preferred embodiment of a fourth variation of the sheath subassembly can be designed, wherein the mounting sleeve 14 and / or the movable sleeve 15, still in their initial positions, as a single component or both, will protrude beyond the proximal edge 8 of the needle hub 1, thereby forming, or also forming, a sheath of the non-injection end 5 together with the needle hub 1. Similarly, the movable sleeve 15 can be configured during insertion of the injection end 3, achieving a very long travel in the proximal direction along the longitudinal axis X of the needle assembly between its initial and final positions, which will allow for a better sheath of the non-injection end 5 than that shown in Figures 35-37.

[0336] Based on the design considerations of the sheath subassembly of this application, which involve the longitudinal dimensions of the mating sleeve 14, the movable sleeve 15, and the second movable component 16, and having been described above with respect to the preferred embodiments of the first and third variations of the sheath subassembly, the preferred embodiments of the fourth variation should be understood and applied in the same way, given the understanding of the unique technical features of the fourth variation.

[0337] In a fourth variation of the sheath subassembly according to this application, the mounting sleeve 14, the movable sleeve 15, and the second movable component 16 are configured to cooperate with each other, and the movable sleeve 15 and the second movable component 16 are kinetically engaged with each other, such that activation of the injection end sheath 31 is achieved by forcing the second movable component 16 to slide and causing the movable sleeve 15 to slide between the respective initial and final positions of each movable component, wherein the movable components are the second movable component 16 and the movable sleeve 15.

[0338] In order to force the second movable component 16 to slide perpendicular to and substantially toward the longitudinal axis X of the needle assembly, and to move the second movable component 16 from its initial position to its final position, a slidable abutment device, namely a slidable abutment surface 67 on the second movable component 16, is designed in the sheath subassembly.

[0339] In order to slidably mount the movable sleeve 15 on the mounting sleeve 14 along the longitudinal axis X of the needle assembly in the proximal direction and guide the movable sleeve 15 to slide on the mounting sleeve 14, a first mounting device and a first guiding device are designed in the sheath sub-assembly, which are two opposing longitudinal grooves 23 on the movable sleeve 15 and two opposing longitudinal protrusions 21 on the mounting sleeve 14.

[0340] To mount the second movable component 16 onto the mounting sleeve 14 perpendicular to and substantially slidable toward the longitudinal axis X of the needle assembly, a second mounting mechanism is designed in the sheath subassembly: two opposing coupling slots 56 on the two opposing arms 33 of the second movable component 16 and two opposing pivot protrusions 18 with handles 19 on the mounting sleeve 14. In a preferred embodiment of a fourth variant of the sheath subassembly, the coupling slots 56 have a dashed straight-line shape.

[0341] The second movable component 16 is prevented from slipping off the mounting sleeve 14 by a protective device consisting of two opposing coupling slots 56 on two opposing arms 33 on the second movable component 16 and two opposing retaining discs 20 on two opposing handles 19 on two opposing pivot protrusions 18 on the mounting sleeve 14.

[0342] To enable the movable sleeve 15 to slide relative to the mounting sleeve 14, a first engagement device is designed in the sheath sub-assembly, namely two opposing longitudinal cutouts 24 on the movable sleeve 15 and two opposing pivot protrusions 18 with handles 19 on the mounting sleeve 14.

[0343] To enable the second movable component 16 to engage during its sliding movement relative to the movable sleeve 15, a second engagement mechanism is designed in the sheath subassembly. This second engagement mechanism consists of two opposing fourth limiting surfaces 58 and two opposing push surfaces 59 on the two opposing arms 33 of the second movable component 16, and two opposing guide surfaces 63 on the two opposing proximal protrusions 62 on the movable sleeve 15. The proximal surfaces of each arm 33 of the second movable component 16 are arranged in a dashed straight line, and the configuration from one end of the arm 33 that together forms the clamp to the other end is, in sequence, a fifth limiting surface 61, a second blocking surface 60, a push surface 59, and a fourth limiting surface 58.

[0344] In order to engage the second movable component 16 in its sliding movement relative to the mounting sleeve 14, a third engagement device is designed in the sheath subassembly, which consists of two opposing coupling slots 56 on the two opposing arms 33 of the second movable component 16 and two opposing pivot protrusions 18 with handles 19 on the mounting sleeve 14.

[0345] To guide the sliding movement of the second movable component 16 relative to the mounting sleeve 14 and on the movable sleeve 15 relative to the longitudinal axis X of the needle assembly, which is perpendicular to and substantially oriented towards the longitudinal axis X, a second guiding device is designed in the sheath subassembly. This device comprises two opposing coupling slots 56, two opposing fourth limiting surfaces 58, and two opposing push surfaces 59 on the two opposing arms 33 of the second movable component 16; two opposing guide surfaces 63 on two opposing proximal protrusions 62 on the movable sleeve 15; and two opposing pivot protrusions 18 on the mounting sleeve 14 with two opposing handles 19. In a preferred embodiment of the fourth variant of the presented sheath subassembly, the coupling slots 56 and their proximal surfaces 57 have a dashed straight-line shape.

[0346] As the second movable component 16 moves from its initial position to its final position, its flat distal wall extending between the arms 33 forms an injection end sheath 31 in the portion of the arms 33 extending toward the clamp. This flat distal wall bends the injection end 3 and sheaths the bent injection end 3 until the second movable component 16 is fully sheathed when it reaches its final position. Essentially simultaneously, the movable sleeve 15 moves axially in the proximal direction towards the needle hub 1, with the needle tube 2 fixedly embedded in the needle hub 1 and further extending beyond the proximal edge 8 of the needle hub 1 until the movable sleeve 15 reaches its final position, where it extends proximally to the needle hub 1 at its furthest point from the needle hub 1. The sheath for the non-injection end 5 formed by the movable sleeve 15 in its final position extends around the entire circumference of the groove exposed from the extended groove 7 of the needle hub 1. During the movement of the second movable component 16 and the movable sleeve 15 from their initial position to their final position, both the injection end 3 and the non-injection end 5 are covered by a sheath.

[0347] The shape of the coupling slot 56 and the shape of the proximal surface arm 33 of the second movable component 16 are configured structurally and dimensionally to interact with each other, and are configured with the remaining structural elements of the second movable component 16 and the remaining components of the needle assembly, so that in the fourth variant of the needle assembly with a sheath sub-assembly, the needle injection end 3 can be effectively and safely bent and effectively and safely sheathed.

[0348] In the preferred embodiment of the fourth variant shown in Figures 35-37, the injection end sheath 31 is activated by forcing the second movable component 16 to slide and causing the movable sleeve 15 to slide, which simultaneously activates the sheath of the non-injection end 5, which is formed by the movable sleeve 15 in its final position.

[0349] In order to hold the movable sleeve 15 and the second movable component 16 relative to the mounting sleeve 14 in their initial positions, a first retaining device is designed in the sheath subassembly. The first retaining device consists of two opposing pivot protrusions 18 on the mounting sleeve 14 with two opposing handles 19, two opposing guide surfaces 63 on two opposing proximal protrusions 62 on the movable sleeve 15, and two opposing coupling slots 56 and two opposing fourth limiting surfaces 58 on two opposing arms 33 of the second movable component 16.

[0350] In order to hold the movable sleeve 15 and the second movable component 16 in their final positions relative to the mounting sleeve 14, a second retaining device is designed in the sheath subassembly. The second retaining device consists of two opposing pivot protrusions 18 on the mounting sleeve 14 with two opposing handles 19, two opposing guide surfaces 63 on two opposing proximal protrusions 62 on the movable sleeve 15, and two opposing coupling slots 56 and two opposing fifth limiting surfaces 61 on two opposing arms 33 of the second movable component 16.

[0351] Furthermore, in order to irreversibly block the movable sleeve 15 and the second movable component 16 from each other in their final positions, a locking device is designed in the sheath subassembly. This locking device consists of two opposing blocking surfaces 64 and two opposing guiding surfaces 63 on two opposing proximal protrusions 62 on the movable sleeve 15, and two opposing second blocking surfaces 60 and two opposing fifth limiting surfaces 61 on two opposing arms 33 on the second movable component 16.

[0352] The method of activating the needle tip sheath 31 by forcing the second movable component 16 to slide relative to the vertical and move toward the needle tip 3 is similar to the method of the sheath subassembly in the first variant shown in Figures 19-21, and similar to the method of the sheath subassembly in the third variant shown in Figures 32-34, wherein the axis Y is perpendicular to the longitudinal axis X of the needle assembly. To cover the needle tip 3, when the user holds the body 43 of the pen syringe 42, the user presses the second movable component 16 against any hard surface, such as a table or tray, via the slidable abutment surface 67 of the second movable component 16, forcing the second movable component 16 to move from its initial position to its final position, together with the included needle tip sheath 31, in a direction toward the needle tip 3 having the needle tip 4. During sliding, the second movable component 16 causes the movable sleeve 15 to move from its initial position to its final position along the longitudinal axis X of the needle assembly and toward the non-injection end 5 of the needle.

[0353] By designing the sheath subassembly according to the fourth variation of the first and second mounting devices, the first and second and third engagement devices, the first and second guiding devices, and the first and second retaining devices, they respectively cooperate with each other in all states and stages of operation of the needle assembly with the sheath subassembly according to this application and are respectively used to correctly realize all indicated functions of the specific technical device. The sliding movement of the second movable component 16 is limited to movement perpendicular to the longitudinal axis X of the needle assembly and substantially in the direction of the longitudinal axis X from its initial position to its final position, and the sliding movement of the movable sleeve 15 is limited to movement along the longitudinal axis X of the needle assembly in the proximal direction and from its initial position to its final position, and is substantially impossible to move in the distal direction of the longitudinal axis X.

[0354] Furthermore, through the design of locking devices in the sheath subassemblies of the movable sleeve 15 and the second movable component 16, which are structurally and dimensionally configured to irreversibly couple with each other when the movable sleeve 15 and the second movable component 16 reach their final positions, the mobility of the movable sleeve 15 and the second movable component 16 is irreversibly prevented, so that once the needle injection end 3 is covered, it is impossible to pull it out again, and preferably the non-injection end 5 of the needle is also covered.

[0355] A detailed supplementary description will be provided based on a preferred embodiment of the fifth variation of the sheath sub-assembly of this application. Figures 38-43 illustrate a preferred embodiment of a fifth variant of the needle assembly and its sheath subassembly according to this application, wherein Figures 38A-38B, 40A-40C, and 41A-41C show a needle assembly comprising three components: a needle hub 1, a non-movable component 14 in the form of a mounting sleeve 14, and a second movable component 16, and Figures 39A-39B, 42A-42C, and 43A-43C show a needle assembly comprising two components: a single integral structure including a non-movable component 14 in the form of a mounting sleeve 14, a needle hub 1 made of the same homogeneous material, and a second movable component 16.

[0356] FIG. 38A-38B , FIG. 40A-40C and Figures 41A-41C In the preferred embodiment of the fifth variant of the sheath subassembly shown, the needle hub 1 is used in Figure 3 The above is shown and combined Figure 3 It has been described.

[0357] The immovable component 14 in the form of a mounting sleeve 14 used in the preferred embodiment of the fifth variant of the sheath subassembly shown in Figures 38A-38B, 40A-40C, and 41A-41C has the technical features of the mounting sleeve 14 shown in Figures 4A and 4B and described above with respect to Figures 4A and 4B, and is also configured with technical means specific to the fifth variant of the sheath subassembly. These technical means are configured at the proximal end of the mounting sleeve 14, and... Figures 38A-38B In the preferred embodiment of the sheath sub-assembly shown, two opposing first proximal protrusions 68 and two opposing second protrusions 69 are formed, while... Figures 40A-40C and Figures 41A-41C In the preferred embodiment of the shown sheath sub-assembly, two opposing second protrusions 69 are formed. Figures 39A-39B , Figures 42A-42C and Figures 43A-43C In a preferred embodiment of the fifth variation of the sheath subassembly shown, the mounting sleeve 14 and the needle seat 1 are formed as a single integral structure, such as... Figures 39A-39B As shown, these additional technical means constitute two opposing first proximal protrusions 68 and two opposing second protrusions 69, while Figures 40A-40C and Figures 41A-41C In a preferred embodiment of the fifth variation of the sheath subassembly shown, the mounting sleeve 14 and the needle seat 1 are formed as a single integral structure, such as... Figures 39A-39B As shown, these additional technical means constitute two opposing first proximal protrusions 68 and two opposing second protrusions 69, while Figures 42A-42C and Figures 43A-43C This forms two second opposing protrusions 69.

[0358] Figures 38A-38B , Figures 40A-40C and Figures 41A-41C The mounting sleeve 14 shown and Figures 39A-39B , Figures 42A-42C and Figures 43A-43C The structural details shown include the technical features of the mounting sleeve 14 and the needle holder 1, with longitudinal dimensions conforming to the ISO 11608 standard. Specifically, as... Figures 38A-38B , Figures 40A-40C and Figures 41A-41CAs shown, the proximal edge 22 of the mounting sleeve 14 does not protrude beyond the proximal edge 8 of the needle hub 1 in the proximal direction, thus not forming a sheath for the non-injection end 5, or not forming a sheath for the non-injection end 5 together with the needle hub 1. However, it should be understood that a preferred embodiment of a fifth variation of the sheath subassembly can be designed, wherein the mounting sleeve 14 will protrude beyond the proximal edge 8 of the needle hub 1 to form a sheath for the non-injection end 5, or also form a sheath for the non-injection end 5 together with the needle hub 1, whether in the initial or final position of the second movable component 16. Similarly, in the structural details of the mounting sleeve 14 and needle hub 1 shown in Figures 39 A-39 B, 42 A-42 C, and 43 A-43 C, the longitudinal dimension can be configured to be larger than the longitudinal dimension specified in the ISO 11608 standard in order to obtain a needle assembly having sheaths for the injection end 3 and the non-injection end 5.

[0359] Regarding design considerations for the fifth variant of the sheath subassembly according to this application, which relate to the longitudinal dimension of the immovable component 14, wherein the mounting sleeve 14 is preferably installed, and the structural details of the technical features including the mounting sleeve 14 and the needle seat 1, particularly the possibility of changing its longitudinal dimension, or in other words, the possibility of adjusting its longitudinal dimension, should be understood similarly to those described above for the preferred embodiment of the first variant of the sheath subassembly, and should be applied to the preferred embodiment of the fifth variant, while understanding the technical features unique to the fifth variant.

[0360] The second movable component 16 used in the preferred embodiment of the fifth variant of the sheath subassembly shown in Figures 38-43 essentially has Figures 6A-6C As shown above and regarding Figures 6A-6C The technical features of the second movable component 16 are described. In particular, the second movable component 16 is non-detachably fixedly connected to the injection end sheath 31 and forms an integral structural member therewith made of the same homogeneous material.

[0361] In a fifth variation of the sheath subassembly according to this application, the mounting sleeve 14 and the second movable component 16 are configured to cooperate with each other such that activation of the injection end sheath 31 is achieved by forcing the second movable component 16 to move between its initial and final positions.

[0362] The foregoing, in conjunction with Figures 4A and 4B and Figures 6A-6C, shows and describes the technical features of the fixed component 14 in the form of the mounting sleeve 14 and the second movable component 16, as well as the technical functions assigned to them in relation to a specific variant of the sheath subassembly according to this application. Reference should be made to the fifth variant of the sheath subassembly, while understanding the technical features unique to the fifth variant.

[0363] To rotatably mount the second movable component 16 onto the mounting sleeve 14 relative to a vertical axis Y, which is perpendicular to the longitudinal axis X of the needle assembly, a mounting device is designed in the sheath subassembly. In a preferred embodiment of the fifth variant of the sheath subassembly, this mounting device consists of two opposing shaped holes 34 and two opposing first tongues 35 on the two opposing arms 33 of the second movable component 16, and two opposing pivot protrusions 18 with handles 19 on the mounting sleeve 14. To engage the second movable component 16 during its rotational movement relative to the mounting sleeve 14, an engagement device is designed, consisting of the two opposing shaped holes 34 and two opposing first tongues 35 on the two opposing arms 33 of the second movable component 16, and the two opposing pivot protrusions 18 with handles 19, and two opposing second proximal protrusions 69 on the mounting sleeve 14 having two opposing guide surfaces 70.

[0364] The second movable component 16 is prevented from slipping off the mounting sleeve 14 by a protective device, which includes two opposing shaped holes 34 and two opposing first tongues 35 on two opposing arms 33 provided on the second movable component 16, and two opposing fixing discs 20 on two opposing handles 19 of two opposing pivot protrusions 18 provided on the mounting sleeve 14.

[0365] To guide the rotational movement of the second movable component 16 relative to the mounting sleeve 14 about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly, a guiding device is designed in the sheath assembly. This guiding device consists of two opposing shaped holes 34, two opposing first tongues 35, two opposing push surfaces 36, and two opposing second tongues 37 on the two opposing arms 33 of the second movable component 16, as well as two opposing pivot protrusions 18 with handles 19 and two opposing second proximal protrusions 69 with two opposing guide surfaces 70 on the mounting sleeve 14.

[0366] In order to hold the second movable component 16 relative to the mounting sleeve 14 in its initial position, a first retaining device is designed in the sheath subassembly. The first retaining device consists of two opposing shaped holes 34 and / or two opposing first limiting surfaces 30 and / or two opposing first tongues 35 and / or two opposing pushing surfaces 36 on the two opposing arms 33 of the second movable component 16, and two opposing pivoting protrusions 18 and / or two opposing first proximal protrusions 68 and / or two opposing second proximal protrusions 69 having two opposing guide surfaces 70 on the mounting sleeve 14.

[0367] The term "and / or" in the preceding paragraph is used to refer to the first retaining device and is intended to cover all preferred embodiments of the fifth variant of the sheath subassembly shown in Figures 38-43. In particular, the term includes... Figures 40A-40C , Figures 41A-41C , Figures 42A-42C and Figures 43A-43C The fifth variant of the sheath subassembly shown, i.e., these embodiments, are made of the same homogeneous material on the mounting sleeve 14 or in the structural details including the needle hub 1 and the mounting sleeve 14, and have two opposing second proximal protrusions 69 configured at the distal end. The term also includes... Figures 38A-38B and Figures 39A-39B The fifth variant of the sheath subassembly shown refers to embodiments made of the same homogeneous material on the mounting sleeve 14 or in the structural details including the needle hub 1 and the mounting sleeve 14, having two opposing first proximal protrusions 68 and two opposing second proximal protrusions 69 disposed at the distal end. Furthermore, the term also includes embodiments of the fifth variant of the sheath subassembly, which may include a second movable component 16 with a different shape, such as... Figures 6A-6C As shown, including shapes such as Figure 6A The second movable component 16 shown has a different shape than that used in the fifth variant embodiment of the sheath subassembly shown in Figures 38-43.

[0368] In order to force the second movable component 16 to rotate about the vertical axis Y, which is perpendicular to the longitudinal axis X of the needle assembly, and to move the component from its initial position to its final position, in the fifth variant of the sheath subassembly, a rotatable abutment device is designed on the second movable component 16, which takes the form of a rotatable abutment surface 32.

[0369] In order to hold the second movable component 16 relative to the mounting sleeve 14 in its final position, a second retaining device is designed in the sheath subassembly. The second retaining device consists of two opposing second limiting surfaces 39 and two opposing shape holes 34 on the two opposing arms 33 of the second movable component 16, and two opposing pivot protrusions 18 on the mounting sleeve 14 having two opposing handles 19 and two opposing second proximal protrusions 69 having two opposing guide surfaces 70.

[0370] In addition, in order to irreversibly stop the second movable component 16 in its final position relative to the immovable sleeve 14, a locking device is designed in the sheath subassembly. The locking device consists of two opposing first blocking surfaces 38 and two opposing second limiting surfaces 39 on the two opposing arms 33 of the second movable component 16, and two opposing second proximal protrusions 69 and two opposing blocking surfaces 71 on the mounting sleeve 14, which have two opposing guide surfaces 70.

[0371] The method of activating the needle injection tip sheath 31 by forcing the second movable component 16 to rotate about a vertical axis Y perpendicular to the longitudinal axis X of the needle assembly and to rotate toward the needle injection tip 3 is substantially similar to the method shown in Figures 19-21, which show the sheath sub-assembly in the first variant. To sheath the needle injection tip 3, when holding the body 43 of the pen syringe 42, the user presses the second movable component 16 against any hard surface, such as a table or tray, via its...

Claims

1. A disposable sterile needle assembly for use with a pen syringe (42), comprising a primary package (45) filled with sterile medicine (47) to form a needle injection system for medical use, including The needle holder (1) has a groove (7) with an attachment device (9) for detachably connecting the needle assembly to the pen syringe (42, 43, 44). A needle tube (2) is fixedly embedded in a needle hub (1), the needle tube having a firing end (3) with an injection end (4) for insertion into the patient to inject a drug (47); and a non-injection end (5) with a non-injection end (6) for piercing a diaphragm (46) of the primary packaging (45) to transfer the drug (47) into the patient. The active sheath assembly for the upper needle injection end is installed on the needle hub (1). in The needle hub (1) and needle tube (2) extend substantially around the longitudinal axis (X) of the needle assembly, which is determined by the longitudinal axis (X) of the needle tube (2). The active sheath subassembly for the needle tip extends substantially around the needle hub (1) and is configured to actively cover the injection end (3) having the injection tip (4) before the needle assembly is separated from the pen syringe (42), and in The active sheath subassembly for the needle tip includes a non-movable component (14) that is non-movably mounted on the needle hub (1) and extends substantially along the longitudinal axis (X) of the needle assembly, a first movable component (15) that is slidably mounted on the non-movable component (14) along the longitudinal axis (X) of the needle assembly in the proximal direction, and a second movable component (16) that is rotatably mounted on the non-movable component (14) about a vertical axis (Y) relative to the longitudinal axis (X) of the needle assembly. The first movable component (15) is movable between its initial position and its final position, in which it extends substantially along the longitudinal axis (X) of the needle assembly; The second movable component (16) is movable between its initial position and its final position, in which it extends substantially perpendicular to the longitudinal axis (X) of the needle assembly; and in the final position, it extends substantially along the longitudinal axis (X) of the needle assembly. in The second movable component (16) is fixedly coupled to the injection end sheath (31); and in the initial positions of the first movable component (15) and the second movable component (16), the injection end (3) with the injection endpoint (4) is not covered, and in the final positions of the first movable component (15) and the movable component (16), the injection end (3) with the injection endpoint (4) is covered; and The immovable component (14), the first movable component (15), and the second movable component (16) are configured to cooperate with each other, and the first movable component (15) and the second movable component (16) are movably engaged with each other, such that... The activation of the injection end sheath (31) is achieved by forcing the second movable component (16) to move and causing the first movable component (15) to move, wherein the activation of the injection end sheath (31) is achieved by each of the second (16) and the first (15) moving between their respective initial and final positions.

2. The active sheath subassembly for the needle injection end according to claim 1, wherein the immovable component (14) constitutes the mounting sleeve (14), and preferably, the first movable component (15) constitutes the movable sleeve (15), the proximal end (25) of which is preferably a flange (25).

3. The sheath sub-assembly according to claim 1 or 2, comprising: A first mounting device (14, 21, 15, 23) for slidably mounting a first movable component (15) onto a non-movable component (14) along the longitudinal axis (X) of the needle assembly in the proximal direction, wherein the first mounting device (14, 21, 15, 23) is preferably at least one longitudinal protrusion (21) disposed on the non-movable component (14), more preferably two opposing longitudinal protrusions (21), and preferably at least one longitudinal groove (23) disposed on the first movable component (15), more preferably two opposing longitudinal grooves (23), and A second mounting device (14, 18, 19, 16, 33, 34, 35) for rotatably mounting the second movable component (16) about a vertical axis (Y) relative to the longitudinal axis (X) of the needle assembly onto the immovable component (14), wherein the second mounting device (14, 18, 19, 16, 33, 34, 35) is preferably at least one pivot protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably, two opposing pivot protrusions (18) with handles (19), and preferably, at least one shape hole (34) and at least one first tongue (35) disposed on at least one arm (33) of the second movable component (16), more preferably, two opposing shape holes (34) and two opposing first tongues (35) on two opposing arms (33).

4. The sheath sub-assembly according to any of the preceding claims, comprising: A first engagement device (14, 18, 19, 15, 24) for engaging a first movable component (15) with a non-movable component (14), wherein, The first engaging device (14, 18, 19, 15, 24) is preferably at least one pivot protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivot protrusions (18) with handles (19), and preferably at least one longitudinal cut (24) disposed on the first movable component (15), more preferably two opposing longitudinal cuts (24), and A second engagement device (15, 25, 28, 16, 33, 35, 36, 37) for engaging a second movable component (16) with a first movable component (15), wherein the second engagement device (15, 25, 28, 16, 33, 35, 36, 37) is preferably disposed on the distal surface (28) of the proximal end (25) of the first movable component (15), and preferably disposed on at least one first tongue (35), at least one bending surface (36) and at least one second tongue (37) on at least one arm (33) of the second movable component (16), more preferably two opposing first tongues (35), two opposing bending surfaces (36) and two opposing second tongues (37) on two opposing arms (33), and A third engagement device (14, 18, 19, 16, 33, 34, 35) for engaging the second movable component (16) with the immovable component (14), wherein the third engagement device (14, 18, 19, 16, 33, 34, 35) is preferably at least one pivot protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivot protrusions (18) with a handle (19), and preferably at least one shape hole (34) and at least one first tongue (35) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing shape holes (34) and two opposing first tongues (35) on two opposing arms (33).

5. The sheath sub-assembly according to any one of the preceding claims, comprising: Protective devices (14, 18, 19, 20, 16, 33, 34, 35) for protecting the second movable component (16) from slipping off the immovable component (14), wherein the protective devices (14, 18, 19, 20, 16, 33, 34, 35) are preferably at least one retaining disc (20) disposed on the handle (19) of at least one pivot protrusion (18) on the immovable component (14), more preferably two opposing retaining discs (20) disposed on two opposing handles (19) of two opposing pivot protrusions (18), and preferably at least one shaped hole (34) and at least one first tongue (35) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing shaped holes (34) and two opposing first tongues (35) on two opposing arms (33).

6. The sheath sub-assembly according to any one of the preceding claims, comprising: First guide devices (14, 21, 15, 23) for guiding the first movable component (15) to slide along the longitudinal axis (X) of the needle assembly in the proximal direction on the immovable component (14), wherein, The first guiding device (14, 21, 15, 23) is preferably at least one longitudinal protrusion (21) disposed on the immovable component (14), more preferably two opposing longitudinal protrusions (21), and preferably at least one longitudinal groove (23) disposed on the first movable component (15), more preferably two opposing longitudinal grooves (23). A second guiding device (14, 18, 19, 15, 25, 28, 16, 33, 34, 35, 36, 37) for guiding the second movable component (16) relative to the immovable component (14) and for rotational movement on the first movable component (15) about a vertical axis (Y) perpendicular to the longitudinal axis (X) of the needle assembly, wherein the second guiding device (14, 18, 19, 15, 25, 28, 16, 33, 34, 35, 36, 37) is preferably at least one pivoting protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably having two A pair of opposing handles (19), two opposing pivot protrusions (18), and preferably a distal surface (28) of the proximal end (25) disposed on the first movable component (15), and preferably at least one shape hole (34), at least one first tongue (35), at least one bendable surface (36) and at least one second tongue (37) disposed on at least one arm (33) of the second movable component (16), more preferably, two opposing shape holes (34), two opposing first tongues (35), two opposing bendable surfaces (36) and two opposing second tongues (37) on two opposing arms (33).

7. The sheath sub-assembly according to any one of the preceding claims, comprising: A first holding device (14, 18, 19, 15, 25, 28, 29, 16, 30, 33, 34, 35, 36, 40) for holding the first movable component (15) and the second movable component (16) in their initial positions with respect to the immovable component (14), wherein, The first retaining device (14, 18, 19, 15, 25, 28, 29, 16, 30, 33, 34, 35, 36, 40) is preferably at least one pivoting protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivoting protrusions (18) with two opposing handles (19), and preferably the distal surface (28) of the proximal end (25) and / or at least one pivoting protrusion (29) disposed on the first movable component (15), more preferably the distal surface (28) of the proximal end (25) and / or two opposing pivoting protrusions (29). 9), and preferably, at least one first limiting surface (30) and / or at least one shape hole (34) and / or at least one first tongue (35) and / or at least one bending push surface (36) and / or at least one third limiting surface (40) are provided on at least one arm (33) of the second movable component (16), more preferably, two opposing first limiting surfaces (30) and / or two opposing shape holes (34) and / or two opposing first tongues (35) and / or two opposing bending push surfaces (36) and / or two opposing third limiting surfaces (40) are provided on two opposing arms (33), and A second retaining device (14, 18, 19, 15, 25, 28, 29, 16, 33, 34, 39, 40) for holding the first movable component (15) and the second movable component (16) relative to the immovable component (14) in their respective final positions, wherein the second retaining device (14, 18, 19, 15, 25, 28, 29, 16, 33, 34, 37, 39, 40) is preferably disposed on the immovable component (14) as at least one pivoting protrusion (18) having a handle (19), more preferably as two opposing pivoting protrusions (18) having two opposing handles (19), and preferably disposed on the distal surface (28) of the proximal end (25) of the first movable component (15) and / or At least one pivoting protrusion (29), more preferably, the distal surface (28) of the proximal end (25) and / or two opposing pivoting protrusions (29), and preferably, at least one second limiting surface (39) and at least one shape hole (34) and / or at least one third limiting surface (40) disposed on at least one arm (33) of the second movable component (16), more preferably, two opposing second limiting surfaces (39) and two opposing shape holes (34) and / or two opposing third limiting surfaces (40) on two opposing arms (33).

8. The sheath sub-assembly according to any one of the preceding claims, comprising: A rotatable abutment device (16, 32) disposed on the second movable component (16) is used to force the second movable component (16) to rotate about a vertical axis (Y) perpendicular to the longitudinal axis (X) of the needle assembly, and to displace the second movable component (16) from its initial position to its final position, wherein, The rotatable abutment device (16, 32) is preferably a rotatable abutment surface (32).

9. The sheath sub-assembly according to any one of the preceding claims, wherein, The activation of the injection end sheath (31) is achieved by moving the second movable component (16) between the respective initial and final positions of the first (15) and the second (16) of the movable components, by forcing the movement of the first movable component (15).

10. The sheath subassembly according to claim 9, comprising: A slidable abutment device (15, 25, 28) is disposed on the first movable component (15) for forcing the first movable component (15) to slide proximally relative to the longitudinal axis (X) of the needle assembly, and for displacing the first movable component (15) from its initial position to its final position, wherein, The sliding abutment device (15, 25, 28) is preferably the distal surface (28) of the proximal end (25).

11. The sheath subassembly according to any one of claims 9 or 10, comprising: Lever devices (15, 29, 16, 33, 40) for rotating the second movable component (16) about a vertical axis (Y) perpendicular to the longitudinal axis (X) of the needle assembly, wherein, The lever device (15, 29, 16, 33, 40) is preferably at least one pivot protrusion (29) disposed on the first movable component (15), more preferably two opposing pivot protrusions (29), and preferably at least one third limiting surface (40) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing third limiting surfaces (40) on two opposing arms (33).

12. The sheath subassembly according to any one of the preceding claims, wherein an irreversible blocking mechanism for an injection end sheath (31) is provided at the covering position of the needle injection end (3) having the injection end point (4), comprising: Locking devices (15, 25, 26, 28, 16, 33, 38, 39) for blocking the first movable component (15) and the second movable component (16) from each other in their final positions, wherein, The locking device (15, 25, 26, 28, 16, 33, 38, 39) is preferably configured with at least one blocking hole (26) and a distal surface (28) on the proximal end (25) of the first movable component (15), more preferably with two opposing blocking holes (26) and distal surfaces (28), and preferably with at least one first blocking surface (38) and at least one second limiting surface (39) on at least one arm (33) of the second movable component (16), more preferably with two opposing first blocking surfaces (38) and two opposing second limiting surfaces (39) on two opposing arms (33).

13. The sheath sub-assembly according to any one of the preceding claims, wherein, The immovable component (14) extends along the longitudinal axis (X) of the needle assembly to such a longitudinal dimension that, in the proximal direction, at least in its initial position and preferably in its final position, it protrudes beyond the needle hub (1) and the first movable component (15), thereby forming a sheath for the non-injection end (5) of the needle at least before the needle assembly is attached to the pen syringe (42), and preferably after the activation of the injection end sheath (31) and the covering of the needle injection end (3).

14. The sheath sub-assembly according to any one of the preceding claims, wherein, The immovable component (14), the first movable component (15), and the second movable component (16) are configured in terms of structure and size to each other such that the first movable component (15) extends along the longitudinal axis (X) of the needle assembly to such a size that it protrudes beyond the needle hub (1) and / or beyond the immovable component (14) at least in its final position in the proximal direction, thereby forming a sheath of the non-injection end (5) of the needle at least after the activation of the injection end sheath (31) and the covering of the needle injection end (3).

15. A disposable sterile needle assembly for use with a pen syringe (42), comprising a primary package (45) filled with sterile medicine (47) to form a needle injection system for medical use, including The needle holder (1) has a groove (7) for detachably connecting the needle assembly to the pen syringe (42, 43, 44). A needle tube (2) is fixedly embedded in a needle hub (1), and the needle tube has an injection end (3) with an injection tip (4) for insertion into the patient to inject a drug (47), and a non-injection end (5) with a non-injection tip (6) for piercing the diaphragm (46) of the primary package (45) to deliver the drug (47) into the patient. The active sheath assembly for the needle injection end is mounted on the needle hub (1). in The needle hub (1) and the needle tube (2) extend substantially around the longitudinal axis (X) of the needle assembly, which is determined by the longitudinal axis (X) of the needle tube (2). The active sheath subassembly for the needle tip extends substantially around the needle hub (1) and is configured to actively cover the injection end (3) having the injection tip (4) before the needle assembly is separated from the pen syringe (42), and in The active sheath subassembly for the needle injection end includes a non-movable component (14) mounted on the needle hub (1) and extending substantially along the longitudinal axis (X) of the needle assembly, and a first movable component (15) and a second movable component (16) rotatably mounted on the non-movable component (14) about a vertical axis (Y) perpendicular to the longitudinal axis (X) of the needle assembly. The first movable component (15) and the second movable component (16) are movable between an initial position and a final position, in which they extend substantially perpendicular to the longitudinal axis (X) of the needle assembly, and in the final position, they extend substantially along the longitudinal axis (X) of the needle assembly. in The second movable component (16) is fixedly coupled to the injection end sheath (31); and in the initial position of the first movable component (15) and the second movable component (16), the injection end (3) with the injection endpoint (4) is not covered, and in the final position of the first movable component (15) and the second movable component (16), the injection end (3) with the injection endpoint (4) is covered; and The immovable component (14), the first movable component (15) and the second movable component (16) are configured to cooperate with each other and the first movable component (15) and the second movable component (16) are movably engaged with each other such that The activation of the injection end sheath (31) is achieved by forcing the movement of either the first movable component (15) or the second movable component (16) of the movable components to cause the movement of the other, with each of the first movable component (15) and the second movable component (16) moving between their respective initial and final positions.

16. The active sheath assembly for the needle injection end according to claim 15, wherein the immovable component (14) constitutes the mounting sleeve (14), and preferably, the first movable component (15) constitutes a clamp configured as substantially cylindrical and incomplete, respectively.

17. The sheath subassembly according to any one of claims 15 or 16, comprising: A first mounting device (14, 8, 19, 15) for rotatably mounting a first movable component (15) onto a non-movable component (14) about a vertical axis (Y) perpendicular to the longitudinal axis (X) of the needle assembly, wherein, The first mounting device (14, 18, 19, 15) is preferably at least one pivot protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivot protrusions (18) with handles (19), and preferably at least one shaped hole and at least one gripping portion disposed on at least one arm of the first movable component (15), more preferably two opposing shaped holes and two opposing gripping portions disposed on at least one arm of the first movable component (15), and A second mounting device (14, 18, 19, 16, 33) for rotatably mounting the second movable component (16) on the immovable component (14) about a vertical axis (Y) perpendicular to the longitudinal axis (X) of the needle assembly, wherein the second mounting device (14, 18, 19, 16, 33) is preferably at least one pivot protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivot protrusions (18) with a handle (19), and preferably at least one shape integral and at least one gripping portion disposed on at least one arm (33) of the second movable component (16), more preferably two opposing shape integrals and two gripping portions disposed on two opposing arms (33) of the second movable component (16).

18. The sheath subassembly according to any one of claims 15 to 17, comprising First engagement devices (14, 18, 19, 15) for engaging a first movable component (15) with a non-movable component (14), wherein, The first engaging device (14, 18, 19, 15) is preferably at least one pivot protrusion (18) with a handle (19) disposed on the immovable component assembly (14), more preferably two opposing pivot protrusions (18) with handles (19), and preferably at least one shape hole and at least one gripping portion disposed on at least one arm of the first movable component (15), more preferably two opposing shape holes and two opposing gripping portions disposed on two opposing arms of the first movable component (15), and A second engagement device (15, 16, 33) for engaging a second movable component (16) with a first movable component (15), wherein the second engagement device (15, 16, 33) is preferably at least one engaging joint disposed between at least one arm (33) of the first movable component (15) and at least one arm (33) of the second movable component (16), more preferably two opposing engaging joints between two opposing arms (33) of the first movable component (15) and two opposing arms (33) of the second movable component (16), and A third engagement device (14, 18, 19, 16, 33) for engaging the second movable component (16) with the immovable component (14), wherein the third engagement device (14, 18, 19, 16, 33) is preferably at least one pivot protrusion (18) with the handle (19) disposed on the immovable component (14), more preferably two opposing pivot protrusions (18) with the handle (19), and preferably at least one shape hole and at least one gripping portion disposed on at least one arm (33) of the second movable component (16), more preferably two opposing shape holes and two opposing gripping portions on two opposing arms (33) of the second movable component (16).

19. The sheath subassembly according to any one of claims 15 to 18, comprising A first protective device (14, 18, 19, 20, 15) for protecting the first movable component (15) from slipping off the immovable components (14, 18, 19, 20), wherein, The first protective device (14, 18, 19, 20, 15) is preferably at least one retaining disc (20) disposed on the handle (19) of at least one pivot protrusion (18) on the immovable component (14), more preferably two opposing retaining discs (20) disposed on two opposing handles (19) of two opposing pivot protrusions (18), and preferably at least one shaped hole and at least one gripping part disposed on at least one arm of the first movable component (15), more preferably two opposing shaped holes and two opposing gripping parts on two opposing arms of the first movable component (15), and A second protective device (14, 18, 19, 20, 16, 33) for protecting the second movable component (16) from slipping off the immovable component (14, 18, 19, 20), wherein the second protective device (14, 18, 19, 20, 16, 33) is preferably at least one retaining disc (20) disposed on the handle (19) of at least one pivot protrusion (18) on the immovable component (14), more preferably two opposing retaining discs (20) on two opposing handles (19) of two opposing pivot protrusions (18), and preferably at least one shaped hole and at least one gripping portion disposed on at least one arm (33) of the second movable component (16), more preferably two opposing shaped holes and two opposing gripping portions on two opposing arms (33) of the second movable component (16).

20. The sheath subassembly according to any one of claims 15 to 19, comprising A first guiding device (14, 18, 19, 48, 50, 15) for guiding the rotational movement of the first movable component (15) about a vertical axis (Y) perpendicular to the longitudinal axis (X) of the needle assembly, wherein, The first guiding device (14, 18, 19, 48, 50, 15) is preferably a guide surface (50) disposed on the immovable component (14) having at least one pivoting protrusion (18) with a handle (19) and an engaging protrusion (48), more preferably two opposing guide surfaces (50) having two opposing pivoting protrusions (18) with two opposing handles (19) and two opposing engaging protrusions (48), and preferably at least one shape hole and at least one gripping portion disposed on the first movable component (15) having at least one arm, more preferably two opposing shape holes and two opposing gripping portions and two opposing arms of the first movable component (15), and A second guide device (14, 18, 19, 16, 33) for guiding the rotational movement of the second movable component (16) relative to the immovable component (14) about a vertical axis (Y) perpendicular to the longitudinal axis (X) of the needle assembly, wherein the second guide device (14, 18, 19, 16, 33) is preferably at least one pivot protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivot protrusions (18) with handles (19), and preferably at least one shape hole and at least one gripping portion disposed on at least one arm (33) of the second movable component (16), more preferably two opposing shape holes and two opposing gripping portions disposed on two opposing arms (33) of the second movable component (16).

21. The sheath subassembly according to any one of claims 15 to 20, comprising A first retaining device (14, 18, 19, 48, 49, 54, 15, 52) for holding the first movable component (15) and the second movable component (16) in their initial positions with respect to the immovable component (14), wherein the first retaining device (14, 18, 19, 48, 49, 54, 15, 52) is preferably disposed on the immovable component (14) having at least one pivoting protrusion (18) with a handle (19), at least one first limiting surface (49) with at least one engaging protrusion (48), and at least one retaining protrusion (54), more preferably being The component comprises two opposing pivot protrusions (18) with two opposing handles (19), two opposing first limiting surfaces (49) with two opposing engagement protrusions (48), and two opposing retaining protrusions (54), and preferably, at least one first blocking surface (52) disposed on at least one arm of the first movable component (15), more preferably, on two opposing first blocking surfaces (52) on two opposing arms of the first movable component (15), and preferably, on at least one arm (33) of the second movable component (16), more preferably, on two opposing arms (33). A second holding device (14, 18, 19, 48, 51, 15, 53) for holding the first movable component (15) and the second movable component (16) in their final positions with respect to the immovable component (14), wherein, The second retaining device (14, 18, 19, 48, 51, 15, 53) is preferably at least one second limiting surface (51) disposed on the immovable component (14) having at least one pivoting protrusion (18) with a handle (19) and at least one engaging protrusion (48), more preferably, a second limiting surface (51) having two opposing pivoting protrusions (18) with two opposing handles (19) and two opposing engaging protrusions (48), and preferably, at least one second blocking surface (53) disposed on at least one arm of the first movable component (15), more preferably, two opposing second blocking surfaces (53) on two opposing arms of the first movable component (15).

22. The sheath subassembly according to any one of claims 15 to 21, comprising: A first rotatable abutment device (15, 55) is disposed on a first movable component (15), the first rotatable abutment device being used to force the first movable component (15) to rotate about a vertical axis (Y) perpendicular to the longitudinal axis (X) of the needle assembly, and to move the first movable component (15) from its initial position to its final position, wherein the first rotatable abutment device (15, 55) is preferably a rotatable abutment surface (55), and A second rotatable abutment (16, 32) is disposed on the second movable component (16), the second rotatable abutment being used to force the second movable component (16) to rotate about a vertical axis (Y) perpendicular to the longitudinal axis (X) of the needle assembly, and to move the second movable component (16) from its initial position to its final position, wherein the second rotatable abutment (16, 32) is preferably a rotatable abutment surface (32).

23. The sheath subassembly according to any one of claims 15 to 22, wherein an irreversible blocking mechanism for an injection end sheath (31) is provided at the covering position of the needle injection end (3) having the injection end point (4), comprising: Locking devices (14, 48, 51, 15, 53) for locking the first movable component (15) and the second movable component (16) in their final positions with respect to the immovable component (14), wherein the locking devices (14, 48, 51, 15, 53) are preferably at least one second limiting surface (51) of at least one engaging protrusion (48) disposed on the immovable component (14), more preferably two opposing second limiting surfaces (51) of two opposing engaging protrusions (48), and preferably at least one second blocking surface (53) disposed on at least one arm of the first movable component (15), more preferably two opposing second blocking surfaces (53) disposed on two opposing arms of the second movable component (15).

24. The sheath subassembly according to any one of claims 15 to 23, wherein, The immovable component (14) extends along the longitudinal axis (X) of the needle assembly to such a longitudinal dimension that it protrudes beyond the needle hub (1) in the proximal direction, thereby forming a sheath for the non-injection end (5) of the needle before the needle assembly is attached to the needle assembly of the pen syringe (42) and after the activation of the injection end sheath (31) and the covering of the needle injection end (3).

25. The sheath subassembly according to any one of claims 15 to 24, wherein, The immovable component (14) and the first movable component (15) are configured to each other in structure and size such that the first movable component (15) extends in its final position along the longitudinal axis (X) of the needle assembly to such a size that it protrudes beyond the needle hub (1) and / or beyond the immovable component (14) in the proximal direction, thereby forming a sheath for the non-injection end (5) of the needle independently and / or together with the immovable component (14) after the injection end sheath (31) is activated and the needle injection end (3) is covered.

26. The sheath subassembly according to any one of claims 15 to 25, wherein, The second movable component (16) and the first movable component (15) constitute an integral structural member made of the same homogeneous material.

27. A disposable sterile needle assembly for use with a pen syringe (42), comprising a primary package (45) filled with sterile medicine (47) to form a needle injection system for medical use, including The needle holder (1) has a groove (7) with an attachment (9) for detachably connecting the needle assembly to a pen syringe (42, 43, 44). A needle (2) is fixedly embedded in a needle hub (1) and has an injection end (3) with an injection endpoint (4) and a non-injection end (5) with a non-injection endpoint (6). The injection endpoint is used to insert into the patient to administer an injection of a drug (47), and the non-injection end is used to puncture the diaphragm (46) of the primary packaging (45) to deliver the drug (47) into the patient. The active sheath sub-assembly of the needle injection end is mounted on the needle hub (1). in The needle hub (1) and the needle tube (2) extend substantially around the longitudinal axis (X) of the needle assembly, which is determined by the longitudinal axis (X) of the needle tube (2). The active sheath subassembly for the needle tip extends substantially around the needle hub (1) and is configured to activate the covering of the injection end (3) having the injection tip (4) before the needle assembly is disengaged from the pen syringe (42), and in The active sheath subassembly for the needle injection end includes a non-movable component (14) that is non-movably mounted on the needle hub (1) and extends substantially along the longitudinal axis (X) of the needle assembly; a first movable component (15) that is slidably mounted on the non-movable component (14) in the proximal direction along the longitudinal axis (X) of the needle assembly; and a second movable component (16) that is slidably mounted on the non-movable component (14) perpendicular to the longitudinal axis (X) of the needle assembly and substantially toward the longitudinal axis (X) of the needle assembly. The first movable component (15) moves between its initial position and its final position, in which it extends substantially along the longitudinal axis (X) of the needle assembly. The second movable component (16) moves between its initial position and its final position, in which it extends substantially perpendicular to the longitudinal axis (X) of the needle assembly. in The second movable member (16) on the distal side of the needle assembly includes an injection end sheath (31); and The second movable component (16) is rotatably coupled to the injection end sheath (31) about a vertical axis (Y1) perpendicular to the longitudinal axis (X) of the needle assembly, the vertical axis (Y1) moving away from the longitudinal axis (X) of the needle assembly; and At the initial positions of the first movable component (15) and the second movable component (16), the injection end (3) with the injection endpoint (4) is not covered, and at the final positions of the first movable component (15) and the second movable component (16), the injection end (3) with the injection endpoint (4) is covered; and The immovable component (14), the first movable component (15), and the second movable component (16) are configured to cooperate with each other, and the first movable component (15) and the second movable component (16) are movably engaged with each other, such that... The activation of the injection end sheath (31) is achieved by forcing the second movable component (16) to move, causing the first movable component (15) to move between its respective initial and final positions.

28. The active sheath subassembly for the needle injection end according to claim 27, wherein the immovable component (14) constitutes an mounting sleeve (14), and preferably, the first movable component (15) constitutes a movable sleeve (15), the movable sleeve including at least one proximal protrusion (62) at its proximal end (25), more preferably, including two opposing proximal protrusions (62).

29. The sheath subassembly according to any one of claims 27 or 28, comprising: First mounting devices (14, 21, 15, 23) for slidably mounting a first movable component (15) onto a non-movable component (14) along the longitudinal axis (X) of the needle assembly in the proximal direction, wherein, The first mounting device (14, 21, 15, 23) is preferably at least one longitudinal protrusion (21) disposed on the immovable component (14), more preferably two opposing longitudinal protrusions (21), and preferably at least one longitudinal groove (23) disposed on the first movable component (15), more preferably two opposing longitudinal grooves (23). A second mounting device (14, 18, 19, 16, 33, 56) is used to slidably mount the second movable component (16) on the immovable component (14) in a direction perpendicular to the longitudinal axis (X) of the needle assembly and substantially toward the longitudinal axis (X) of the needle assembly, wherein the second mounting device (14, 18, 19, 16, 33, 56) is preferably at least one pivot protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivot protrusions (18) with handles (19), and preferably at least one connecting groove (56) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing connecting grooves (56) on two opposing arms (33).

30. The sheath subassembly according to any one of claims 27 to 29, comprising A first engagement device (14, 18, 19, 15, 24) for engaging a first movable component (15) with a non-movable component (14), wherein, The first engaging device (14, 18, 19, 15, 24) is preferably at least one pivot protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivot protrusions (18) with handles (19), and preferably at least one longitudinal cut (24) disposed on the first movable component (15), more preferably two opposing longitudinal cuts (24), and A second engagement device (15, 62, 63, 16, 33, 58, 59) for engaging a second movable component (16) with a first movable component (15), wherein the second engagement device (15, 62, 63, 16, 33, 58, 59) is preferably at least one guide surface (63) of at least one proximal protrusion (62) disposed on the first movable component (15), more preferably two opposing guide surfaces (63) of two opposing proximal protrusions (62), and preferably at least one fourth limiting surface (58) and at least one push surface (59) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing fourth limiting surfaces (58) and two opposing push surfaces (59) on two opposing arms (33), and A third engagement device (14, 18, 19, 16, 33, 56) for engaging the second movable component (16) with the immovable component (14), wherein the third engagement device (14, 18, 19, 16, 33, 56) is preferably at least one pivot protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivot protrusions (18) with handles (19), and preferably at least one coupling slot (56) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing coupling slots (56) on two opposing arms (33), and A fourth engagement device (15, 65, 31, 66) for engaging the injection end sheath (31) with the first movable component (15), wherein the fourth engagement device (15, 65, 31, 66) is preferably disposed on the distal surface (65) of the first movable component (15), and preferably disposed on at least one bending push surface (66) of the injection end sheath (31), more preferably two opposing bending push surfaces (66).

31. The sheath subassembly according to any one of claims 27 to 30, comprising Protective devices (14, 18, 19, 20, 16, 33, 56) for protecting the second movable component (16) from slipping off the immovable component (14), wherein the protective devices (14, 18, 19, 20, 16, 33, 56) are preferably at least one retaining disc (20) disposed on the handle (19) of at least one pivot protrusion (18) on the immovable component (14), more preferably two opposing retaining discs (20) on two opposing handles (19) of two opposing pivot protrusions (18), and preferably at least one coupling slot (56) disposed on at least one arm (33) of the second movable component (16), more preferably coupling slots (56) on two opposing arms (33).

32. The sheath subassembly according to any one of claims 27 to 31, comprising: A first guide device (14, 21, 15, 23) for guiding the sliding movement of the first movable component (15) on the immovable component (14) along the longitudinal axis (X) of the needle assembly in the proximal direction, wherein the first guide device (14, 21, 15, 23) is preferably at least one longitudinal protrusion (21) disposed on the immovable component (14), more preferably two opposing longitudinal protrusions (21), and preferably at least one longitudinal groove (23) disposed on the first movable component (15), more preferably two opposing longitudinal grooves (23), and Second guiding devices (14, 18, 19, 15, 62, 63, 16, 33, 56, 58, 59) for guiding the sliding movement of the second movable component (16) relative to the immovable component (14) and the first movable component (15), the sliding movement being perpendicular to the longitudinal axis (X) of the needle assembly and substantially toward the longitudinal axis (X) of the needle assembly, wherein, The second guiding device (14, 18, 19, 15, 62, 63, 16, 33, 56, 58, 59) is preferably at least one pivoting protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivoting protrusions (18) having two opposing handles (19), and preferably at least one guiding surface (63) of at least one proximal protrusion (62) disposed on the first movable component (15), more preferably two opposing guiding surfaces (63) on two opposing proximal protrusions (62), and preferably at least one coupling slot (56) and at least one fourth limiting surface (58) and at least one push surface (59) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing connecting slots (56) and two opposing fourth limiting surfaces (58) and two opposing push surfaces (59) on two opposing arms (33), and A third guiding device (15, 65, 31, 66) for guiding the injection end sheath (31) to rotate about a vertical axis (Y1) perpendicular to the longitudinal axis (X) of the needle assembly on a first movable component (15), wherein the vertical axis (Y1) is away from the longitudinal axis (X) of the needle assembly. The third guiding device (15, 65, 31, 66) is preferably a distal surface (65) disposed on the first movable component (15), and preferably at least one curved push surface (66) disposed on the injection end sheath (31), more preferably two opposing curved push surfaces (66).

33. The sheath subassembly according to any one of claims 27 to 32, comprising A first retaining device (14, 18, 19, 15, 62, 63, 16, 33, 56, 58) for holding the first movable component (15) and the second movable component (16) in their initial positions with respect to the immovable component (14), wherein the first retaining device (14, 18, 19, 15, 62, 63, 16, 33, 56, 58) is preferably at least one pivoting protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivoting protrusions (18) having two opposing handles (19), and preferably disposed on the first movable component (14). At least one guide surface (63) of at least one proximal protrusion (62) on a movable component (15), more preferably, two opposing guide surfaces (63) on two opposing proximal protrusions (62), and preferably, at least one coupling slot (56) and at least one fourth limiting surface (58) disposed on at least one arm (33) of a second movable component (16), more preferably, two opposing coupling slots (56) and two opposing fourth limiting surfaces (58) on two opposing arms (33), and A second holding device (14, 18, 19, 15, 62, 63, 16, 33, 56, 61) for holding the first movable component (15) and the second movable component (16) in their final positions with respect to the immovable component (14), wherein, The second retaining device (14, 18, 19, 15, 62, 63, 16, 33, 56, 61) is preferably at least one pivoting protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivoting protrusions (18) with two opposing handles (19), and preferably at least one guide surface (63) of at least one proximal protrusion (62) disposed on the first movable component (15), more preferably two opposing guide surfaces (63) on two opposing proximal protrusions (62), and preferably at least one coupling slot (56) and at least one fifth limiting surface (61) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing coupling slots (56) and two opposing fifth limiting surfaces (61) on two opposing arms (33).

34. The sheath subassembly according to any one of claims 27 to 33, comprising A sliding abutment device (16, 67) is disposed on the second movable component (16), the sliding abutment device being used to force the second movable component (16) to slide perpendicular to and substantially toward the longitudinal axis (X) of the needle assembly, and to move the second movable component (16) from its initial position to its final position, wherein, The sliding abutment device (16, 67) is preferably a sliding abutment surface (67).

35. The sheath subassembly according to any one of claims 27 to 34, wherein an irreversible blocking mechanism for the injection end sheath (31) is provided at the covered position of the needle injection end (3) having the injection end point (4), comprising: Locking devices (15, 62, 63, 64, 16, 33, 60, 61) for blocking the first movable component (15) and the second movable component (16) from each other in their final positions, wherein, The locking device (15, 62, 63, 64, 16, 33, 60, 61) is preferably at least one blocking surface (64) and at least one guiding surface (63) of at least one proximal protrusion (62) disposed on the first movable component (15), more preferably two opposing blocking surfaces (64) and two opposing guiding surfaces (63) on two opposing proximal protrusions (62), and preferably at least one second blocking surface (60) and at least one fifth limiting surface (61) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing second blocking surfaces (60) and two opposing fifth limiting surfaces (61) on two opposing arms (33).

36. The sheath subassembly according to any one of claims 27 to 35, wherein, The coupling slot (56) of the second movable component (16) is in a straight line form.

37. The sheath subassembly according to any one of claims 27 to 36, wherein, The immovable component (14) extends along the longitudinal axis (X) of the needle assembly to such a longitudinal dimension that, at least in its initial position and preferably in its final position in the proximal direction, it protrudes beyond the needle hub (1) and beyond the first movable component (15), thereby forming a sheath for the non-injection end (5) of the needle, at least before the needle assembly is attached to the pen syringe (42) and preferably after the injection end sheath (31) is activated and the needle injection end (3) is covered.

38. The sheath subassembly according to any one of claims 27 to 37, wherein, The immovable component (14), the first movable component (15), and the second movable component (16) are configured in terms of structure and size to each other such that the first movable component (15) extends along the longitudinal axis (X) of the needle assembly to such a size that it protrudes beyond the needle hub (1) and / or the immovable component (14) at least in its final position in the proximal direction, thereby forming a sheath for the non-injection end (5) of the needle at least after the activation of the injection end sheath (31) and the covering of the needle injection end (3).

39. A disposable sterile needle assembly for use with a pen syringe (42), comprising a primary package (45) filled with sterile medicine (47) to form a needle injection system for medical use, including The needle holder (1) has a groove (7) with an attachment (9) for detachably connecting the needle assembly to a pen syringe (42, 43, 44). A needle (2) is fixedly embedded in a needle hub (1) and has an injection end (3) with an injection endpoint (4) and a non-injection end (5) with a non-injection endpoint (6). The injection endpoint is used to insert into the patient to administer an injection of a drug (47), and the non-injection end is used to puncture the diaphragm (46) of the primary packaging (45) to transfer the drug (47) into the patient. The active sheath sub-assembly of the needle injection end is mounted on the needle hub (1). in The needle hub (1) and needle tube (2) extend substantially around the longitudinal axis (X) of the needle assembly, which is determined by the longitudinal axis (X) of the needle tube (2). The active sheath subassembly for the needle tip extends substantially around the needle hub (1) and is configured to activate the sheathing of the injection end (3) having the injection tip (4) before the needle assembly is disengaged from the pen syringe (42), and in The active sheath subassembly for the needle injection end includes a non-movable component (14) that is non-movably mounted on the needle hub (1) and extends substantially along the longitudinal axis (X) of the needle assembly; a first movable component (15) that is slidably mounted on the non-movable component (14) in the proximal direction along the longitudinal axis (X) of the needle assembly; and a second movable component (16) that is slidably mounted on the non-movable component (14) perpendicular to the longitudinal axis (X) of the needle assembly and substantially toward the longitudinal axis (X) of the needle assembly. The first movable component (15) moves between its initial position and its final position, in which it extends substantially along the longitudinal axis (X) of the needle assembly. The second movable component (16) moves between its initial position and its final position, in which it extends substantially perpendicular to the longitudinal axis (X) of the needle assembly. in, The second movable component (16) on the distal side of the needle assembly includes an injection end sheath (31); and The second movable component (16) is fixedly coupled to the injection end sheath (31); and in the initial positions of the first movable component (15) and the second movable component (16), the injection end (3) with the injection tip (4) is not covered, and in the final positions of the first movable component (15) and the second movable component (16), the injection end (3) with the injection tip (4) is covered; and The immovable component (14), the first movable component (15), and the second movable component (16) are configured to cooperate with each other, and the first movable component (15) and the second movable component (16) are movably engaged with each other, such that... The activation of the injection end cap (31) is achieved by forcing the second movable component (16) to move, causing the first movable component (15) to move between its respective initial and final positions.

40. The active sheath assembly for the needle injection end according to claim 39, wherein the immovable component (14) constitutes an mounting sleeve (14), and preferably, the first movable component (15) constitutes a movable sleeve (15), the movable sleeve including at least one proximal protrusion (62) at its proximal end (25), more preferably, including two opposing proximal protrusions (62).

41. The sheath subassembly according to any one of claims 39 or 40, comprising First mounting devices (14, 21, 15, 23) for slidably mounting a first movable component (15) onto a non-movable component (14) along the longitudinal axis (X) of the needle assembly in the proximal direction, wherein, The first mounting device (14, 21, 15, 23) is preferably at least one longitudinal protrusion (21) disposed on the immovable component (14), more preferably two opposing longitudinal protrusions (21), and preferably at least one longitudinal groove (23) disposed on the first movable component (15), more preferably two opposing longitudinal grooves (23). A second mounting device (14, 18, 19, 16, 33, 56) is used to slidably mount the second movable component (16) on the immovable component (14) in a direction perpendicular to the longitudinal axis (X) of the needle assembly and substantially toward the longitudinal axis (X) of the needle assembly, wherein the second mounting device (14, 18, 19, 16, 33, 56) is preferably at least one pivot protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivot protrusions (18) with handles (19), and preferably at least one connecting groove (56) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing connecting grooves (56) on two opposing arms (33).

42. The sheath subassembly according to any one of claims 39 to 41, comprising A first engagement device (14, 18, 19, 15, 24) for engaging a first movable component (15) with a non-movable component (14), wherein, The first engaging device (14, 18, 19, 15, 24) is preferably at least one pivot protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivot protrusions (18) with handles (19), and at least one longitudinal cut (24) disposed on the first movable component (15), more preferably two opposing longitudinal cuts (24), and A second engagement device (15, 62, 63, 16, 33, 58, 59) for engaging a second movable component (16) with a first movable component (15), wherein the second engagement device (15, 62, 63, 16, 33, 58, 59) is preferably provided on at least one guide surface (63) of at least one proximal protrusion (62) on the first movable component (15), more preferably on two opposing guide surfaces (63) of two opposing proximal protrusions (62), and preferably on at least one fourth limiting surface (58) and at least one push surface (59) disposed on at least one arm (33) of the second movable component (16), more preferably on two opposing fourth limiting surfaces (58) and two opposing push surfaces (59) of two opposing arms (33), and A third engagement device (14, 18, 19, 16, 33, 56) for engaging the second movable component (16) with the immovable component (14), wherein the third engagement device (14, 18, 19, 16, 33, 56) is preferably at least one pivot protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivot protrusions (18) with handles (19), and preferably at least one coupling slot (56) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing coupling slots (56) on two opposing arms (33).

43. The sheath subassembly according to any one of claims 39 to 42, comprising Protective devices (14, 18, 19, 20, 16, 33, 56) for protecting the second movable component (16) from slipping off the immovable component (14), wherein the protective devices (14, 18, 19, 20, 16, 33, 56) are preferably at least one retaining disc (20) disposed on the handle (19) of at least one pivot protrusion (18) on the immovable component (14), more preferably two opposing retaining discs (20) on two opposing handles (19) of two opposing pivot protrusions (18), and preferably at least one coupling slot (56) disposed on at least one arm (33) of the second movable component (16), more preferably coupling slots on two opposing arms (33).

44. The sheath subassembly according to any one of claims 39 to 43, comprising A first guide device (14, 21, 15, 23) for guiding the sliding movement of the first movable component (15) on the immovable component (14) along the longitudinal axis (X) of the needle assembly in the proximal direction, wherein the first guide device (14, 21, 15, 23) is preferably at least one longitudinal protrusion (21) disposed on the immovable component (14), more preferably two opposing longitudinal protrusions (21), and preferably at least one longitudinal groove (23) disposed on the first movable component (15), more preferably two opposing longitudinal grooves (23), and Second guide devices (14, 18, 19, 15, 62, 63, 16, 33, 56, 58, 59) for guiding the second movable component (16) to slide relative to the immovable component (14) and the first movable component (15), the sliding movement being perpendicular to the longitudinal axis (X) of the needle assembly and substantially toward the longitudinal axis (X) of the needle assembly, wherein, The second guiding device (14, 18, 19, 15, 62, 63, 16, 33, 56, 58, 59) is preferably at least one pivot protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivot protrusions (18) with two opposing handles (19), and preferably at least one guide surface (63) of at least one proximal protrusion (62) disposed on the first movable component (15), more preferably two opposing guide surfaces (63) on two opposing proximal protrusions (62), and preferably at least one coupling slot (56) and at least one fourth limiting surface (58) and at least one push surface (59) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing coupling slots (56) and two opposing fourth limiting surfaces (58) and two opposing push surfaces (59) on two opposing arms (33).

45. The sheath subassembly according to any one of claims 39 to 44, comprising A first retaining device (14, 18, 19, 15, 62, 63, 16, 33, 56, 58) for holding the first movable component (15) and the second movable component (16) in their initial positions with respect to the immovable component (14), wherein the first retaining device (14, 18, 19, 15, 62, 63, 16, 33, 56, 58) is preferably at least one pivoting protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivoting protrusions (18) having two opposing handles (19), and preferably disposed on the first movable component (14). At least one guide surface (63) of at least one proximal protrusion (62) on a movable component (15), more preferably, two opposing guide surfaces (63) on two opposing proximal protrusions (62), and preferably, at least one coupling slot (56) and at least one fourth limiting surface (58) disposed on at least one arm (33) of a second movable component (16), more preferably, two opposing coupling slots (56) and two opposing fourth limiting surfaces (58) on two opposing arms (33), and Second holding devices (14, 18, 19, 15, 62, 63, 16, 33, 56, 61) for holding the first movable component (15) and the second movable component (16) in their final positions with respect to the immovable component (14), wherein, The second retaining device (14, 18, 19, 15, 62, 63, 16, 33, 56, 61) is preferably at least one pivoting protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivoting protrusions (18) with two opposing handles (19), and preferably at least one guide surface (63) of at least one proximal protrusion (62) disposed on the first movable component (15), more preferably two opposing guide surfaces (63) on two opposing proximal protrusions (62), and preferably at least one coupling slot (56) and at least one fifth limiting surface (61) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing coupling slots (56) and two opposing fifth limiting surfaces (61) on the two opposing arms (33).

46. ​​The sheath subassembly according to any one of claims 39 to 45, comprising: A sliding abutment device (16, 67) is disposed on the second movable component (16), the sliding abutment device being used to force the second movable component (16) to slide perpendicular to and substantially toward the longitudinal axis (X) of the needle assembly, and to move the second movable component (16) from its initial position to its final position, wherein, The sliding abutment device (16, 67) is preferably a sliding abutment surface (67).

47. The sheath subassembly according to any one of claims 39 to 46, wherein an irreversible blocking mechanism for the injection end sheath (31) is provided at the covered position of the needle injection end (3) having the injection end point (4), comprising: Locking devices (15, 62, 63, 64, 16, 33, 60, 61) for blocking the first movable component (15) and the second movable component (16) from each other in their final positions, wherein, The locking device (15, 62, 63, 64, 16, 33, 60, 61) is preferably at least one blocking surface (64) and at least one guiding surface (63) of at least one proximal protrusion (62) disposed on the first movable component (15), more preferably two opposing blocking surfaces (64) and two opposing guiding surfaces (63) on two opposing proximal protrusions (62), and preferably at least one second blocking surface (60) and at least one fifth limiting surface (61) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing second blocking surfaces (60) and two opposing fifth limiting surfaces (61) on two opposing arms (33).

48. The sheath subassembly according to any one of claims 39 to 47, wherein, The coupling slot (56) of the second movable component (16) is in the form of a dashed straight line.

49. The sheath subassembly according to any one of claims 39 to 48, wherein, The immovable component (14) extends along the longitudinal axis (X) of the needle assembly to such a longitudinal dimension that, at least in its initial position and preferably in its final position in the proximal direction, it protrudes beyond the needle hub (1) and beyond the first movable component (15), thereby forming a sheath for the non-injection end (5) of the needle, at least before the needle assembly is attached to the pen syringe (42) and preferably after the injection end sheath (31) is activated and the needle injection end (3) is covered.

50. The sheath subassembly according to any one of claims 39 to 49, wherein, The immovable component (14), the first movable component (15), and the second movable component (16) are configured in terms of structure and size to each other such that the first movable component (15) extends along the longitudinal axis (X) of the needle assembly to such a size that it protrudes beyond the needle hub (1) and / or the immovable component (14) at least in its final position in the proximal direction, thereby forming a sheath for the non-injection end (5) of the needle at least after the activation of the injection end sheath (31) and the covering of the needle injection end (3).

51. A disposable sterile needle assembly for use with a pen syringe (42), comprising a primary package (45) filled with sterile medicine (47) to form a needle injection system for medical use, including The needle holder (1) has a groove (7) with an attachment (9) for detachably connecting the needle assembly to a pen syringe (42, 43, 44). A needle (2) is fixedly embedded in a needle hub (1) and has an injection end (3) with an injection endpoint (4) and a non-injection end (5) with a non-injection endpoint (6). The injection endpoint is used to insert into the patient to inject a drug (47), and the non-injection end is used to puncture the diaphragm (46) of the primary packaging (45) to transfer the drug (47) into the patient. The active sheath sub-assembly of the needle injection end is mounted on the needle hub (1). in The needle hub (1) and needle tube (2) extend substantially around the longitudinal axis (X) of the needle assembly, which is determined by the longitudinal axis (X) of the needle tube (2). The active sheath subassembly for the needle tip extends substantially around the needle hub (1) and is configured to activate the sheathing of the injection end (3) having the injection tip (4) before the needle assembly is disengaged from the pen syringe (42), and in The active sheath subassembly for the needle injection end includes a non-movable component (14) and a second movable component (16). The non-movable component is non-movably mounted on the needle hub (1) and extends substantially along the longitudinal axis (X) of the needle assembly. The second movable component is rotatably mounted on the non-movable component (14) about a vertical axis (Y) perpendicular to the longitudinal axis (X) of the needle assembly. The second movable component (16) moves between its initial position and its final position, in the initial position extending substantially perpendicular to the longitudinal axis (X) of the needle assembly, and in the final position extending substantially along the longitudinal axis (X) of the needle assembly. in The second movable component (16) is fixedly coupled to the injection end sheath (31); and in the initial position of the second movable component (16), the injection end (3) with the injection endpoint (4) is not covered, and in the final position of the second movable component (16), the injection end (3) with the injection endpoint (4) is covered; and The immovable component (14) and the second movable component (16) are configured to cooperate with each other, such that The activation of the injection end sheath (31) is achieved by forcing the second movable component (16) to move between its initial position and its final position.

52. The active sheath assembly for the needle injection end according to claim 51, wherein, The non-movable component (14) constitutes the mounting sleeve (14).

53. The sheath subassembly according to claim 51 or 52, comprising: Mounting devices (14, 18, 19, 16, 33, 34, 35) for rotatably mounting the second movable component (16) onto the non-movable component (14) about a vertical axis (Y) perpendicular to the longitudinal axis (X) of the needle assembly, wherein, The mounting device (14, 18, 19, 16, 33, 34, 35) is preferably at least one pivot protrusion (18) with a handle (19) disposed on the immovable component (14), more preferably two opposing pivot protrusions (18) with a handle (19), and preferably at least one shape hole (34) and at least one first tongue (35) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing shape holes (34) and two opposing first tongues (35) on two opposing arms (33).

54. The sheath subassembly according to any one of claims 51 to 53, comprising Engaging devices (14, 18, 19, 69, 70, 16, 33, 34, 35) for engaging a second movable component (16) with a non-movable component (14), wherein the engaging devices (14, 18, 19, 69, 70, 16, 33, 34, 35) are preferably at least one pivoting protrusion (18) with a handle (19) disposed on the non-movable component (14) and at least one second proximal protrusion (6) with at least one guide surface (70). 9), more preferably two opposing pivot protrusions (18) having a handle (19) and two opposing second proximal protrusions (69) having two opposing guide surfaces (70), and preferably at least one first tongue (35) and at least one shape hole (34) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing first tongues (35) and two opposing shape holes (34) on two opposing arms (33).

55. The sheath subassembly according to any one of claims 51 to 54, comprising Protective devices (14, 18, 19, 20, 16, 33, 34, 35) for protecting the second movable component (16) from slipping off the immovable component (14), wherein the protective devices (14, 18, 19, 20, 16, 33, 34, 35) are preferably at least one retaining disc (20) disposed on the handle (19) of at least one pivot protrusion (18) on the immovable component (14), more preferably two opposing retaining discs (20) on two opposing handles (19) of two opposing pivot protrusions (18), and preferably at least one shaped hole (34) and at least one first tongue (35) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing shaped holes (34) and two opposing first tongues (35) on two opposing arms (33).

56. The sheath subassembly according to any one of claims 51 to 55, comprising: A guiding device (14, 18, 19, 69, 70, 16, 33, 34, 35, 36, 37) for guiding the rotational movement of the second movable component (16) relative to the immovable component (14) about a vertical axis (Y) perpendicular to the longitudinal axis (X) of the needle assembly, wherein the guiding device (14, 18, 19, 69, 70, 16, 33, 34, 35, 36, 37) is preferably at least one pivoting protrusion (18) with a handle (19) and at least one second proximal protrusion (69) with at least one guiding surface (70) disposed on the immovable component (14), more preferably Optionally, there are two opposing pivot protrusions (18) having a handle (19) and two opposing second proximal protrusions (69) having two opposing guide surfaces (70), and preferably, at least one shape hole (34), at least one first tongue (35), at least one bendable surface (36) and at least one second tongue (37) disposed on at least one arm (33) of the second movable component (16), more preferably, two opposing shape holes (34), two opposing first tongues (35), two opposing bendable surfaces (36) and two opposing second tongues (37) on two opposing arms (33).

57. The sheath subassembly according to any one of claims 51 to 56, comprising A first retaining device (14, 18, 19, 68, 69, 70, 16, 30, 33, 34, 35, 36) for holding the second movable component (16) in its initial position with respect to the immovable component (14), wherein the first retaining device (14, 18, 19, 68, 69, 70, 16, 30, 33, 34, 35, 36) is preferably at least one pivoting protrusion (18) with a handle (19) and / or at least one first proximal protrusion (68) and / or at least one second proximal protrusion (69) with a guide surface (70) disposed on the immovable component (14), more preferably two phases with handles (19). The pivoting protrusion (18), and / or two opposing first proximal protrusions (68) and / or two opposing second proximal protrusions (69) having two opposing guide surfaces (70), and preferably, at least one shape hole (34) and / or at least one first limiting surface (30) and / or at least one first tongue (35) and / or at least one bending push surface (36) disposed on at least one arm (33) of the second movable component (16), more preferably, two opposing shape holes (34) and / or two opposing first limiting surfaces (30) and / or two opposing first tongues (35) and / or two opposing bending push surfaces (36) on two opposing arms (33), and For attaching the second movable component (16) A second retaining device (14, 18, 19, 69, 70, 16, 33, 34, 39) is held in its initial position with respect to the immovable component (14), wherein the second retaining device (14, 18, 19, 69, 70, 16, 33, 34, 39) is preferably disposed on the immovable component (14) at least one pivoting protrusion (18) with a handle (19) and at least one second proximal protrusion (69) with at least one guide surface (70), more preferably two pivoting protrusions (18) with two opposing handles (19) and two opposing second proximal protrusions (69) with two opposing guide surfaces (70), and preferably disposed on at least one arm (33) of the second movable component (16) at least one second limiting surface (39) and at least one shape hole (34), more preferably two opposing second limiting surfaces (39) and two opposing shape holes (34) on the two opposing arms (33).

58. The sheath subassembly according to any one of claims 51 to 57, comprising A rotatable abutment device (16, 32) is disposed on a second movable component (16) for forcing the second movable component (16) to rotate about a vertical axis (Y) perpendicular to the longitudinal axis (X) of the needle assembly, and for displacing the second movable component (16) from its initial position to its final position, wherein the rotatable abutment device (16, 32) is preferably a rotatable abutment surface (32).

59. The sheath subassembly according to any one of claims 51 to 58, wherein an irreversible blocking mechanism for an injection end sheath (31) is provided at the coverage position of the needle injection end (3) having the injection endpoint (4), comprising: Locking devices (14, 69, 70, 71, 16, 33, 38, 39) for blocking the immovable component (14) and the second movable component (16) from each other in their final positions, wherein, The locking device (14, 69, 70, 71, 16, 33, 38, 39) is preferably at least one second proximal protrusion (69) having at least one guide surface (70) and at least one blocking surface (71) disposed on the immovable component (14), more preferably two opposing second proximal protrusions (69) having two opposing guide surfaces (70) and two opposing blocking surfaces (71), and preferably at least one first blocking surface (38) and at least one second limiting surface (39) disposed on at least one arm (33) of the second movable component (16), more preferably two opposing first blocking surfaces (38) and two opposing second limiting surfaces (39) on two opposing arms (33).

60. The sheath subassembly according to any one of claims 51 to 59, wherein, The immovable component (14) extends along the longitudinal axis (X) of the needle assembly to such a longitudinal dimension that it protrudes beyond the needle hub (1) in the proximal direction, thereby forming a sheath for the non-injection end (5) of the needle before the needle assembly is attached to the pen syringe (42) and after the activation of the injection end sheath (31) and the covering of the needle injection end (3).

61. The sheath sub-assembly according to any one of the preceding claims, wherein, The immovable component (14) together with the needle seat (1) constitutes an integral structure made of the same homogeneous material.

62. The sheath sub-assembly according to any one of the preceding claims, wherein, The second movable component part (16) together with the injection end sheath (31) constitutes an integral structure made of the same homogeneous material.

63. The sheath subassembly according to any one of the preceding claims, comprising a supplementary sheath (5) for the non-injection end of the needle, the supplementary sheath being configured such that, after activation of the injection end sheath (31) and after separation of the needle assembly from the pen syringe (42), it is adapted to engage with the needle assembly on the proximal side of the needle assembly, wherein the supplementary sheath for the non-injection end (5) is permanently or detachably coupled to the sheath subassembly and is preferably a cork (41) or a separate part of the needle assembly device not connected to the sheath subassembly and preferably a dome (17) of the needle container (11) of the needle assembly.

64. A component for an active sheath subassembly for a needle injection tip and a disposable sterile needle assembly, comprising the technical features of a non-removable component (14) according to any one of claims 1 to 63.

65. A component for an active sheath subassembly for a needle injection tip and a disposable sterile needle assembly, comprising the technical features of a first movable component (15) according to any one of claims 1 to 50 or 61 to 63.

66. A component for an active sheath subassembly for a needle injection tip and a disposable sterile needle assembly, comprising the technical features of a second movable component (16) according to any one of claims 1 to 63.

67. A unit package comprising a disposable sterile needle assembly with an active needle tip sheath subassembly according to any one of claims 1 to 63, protected by at least one of two components, the two components including an outer needle shield (10) that closes the needle tip (3) and a needle container (11) that houses the disposable sterile needle assembly with the active needle tip sheath subassembly, and protected by a seal (12) that tightly closes the sterile needle assembly with the sheath subassembly.

68. A user package comprising a set of unit packages according to claim 67, and preferably comprising a pen syringe (42) having a primary package (45) filled with sterile medicine (47), the pen syringe being configured to cooperate with each other to inject the medicine (47) into a patient in a manner safe for the user, including reducing the risk of infection by pathogens transmitted through the patient's blood.

69. A needle injection system for medical use, comprising a disposable sterile needle assembly with an active sheath subassembly for the needle tip according to any one of claims 1 to 63, and a pen syringe (42) comprising a primary package (45) containing a sterile medicine (47), configured to work together to inject the medicine (47) into a patient in a manner safe for the user, including reducing the risk of infection by pathogens transmitted through the patient's blood.

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