Method for assembling needle safety device

Abstract

A method of assembling and packaging a medical needle device having a double-ended needle (116) includes a container (170) having a closed end and an open end to receive a spring-actuated safety needle device (110) to provide passive needle-stick protection for a non-patient end (118) of the needle (116). The method includes performing the independent steps of (i) assembling a first subassembly (101) by mounting a shield (114) to a tubular housing (130) to form a telescoping device (104) and engaging the telescoping device (104) within a container (170), (ii) assembling a second subassembly (102) by fixing a double-ended needle (116) within a needle mount (140), with a mounting element disposed on an outer surface of the needle mount (140). The tubular housing (130) includes (a) a mounting member on an inner surface to engage a mounting element of the needle mount (140), and (b) a spring to urge movement of the double-ended needle (116) during use to a guard position in which the needle (116) extends at an angle inclined with respect to a longitudinal axis of the tubular housing (130), to place the non-patient end (118) of the needle (116) at a location adjacent the inner wall of the tubular housing (130). The method further includes inserting the second sub-assembly (102) into the tubular housing (130) to secure the mounting element of the needle mount (140) to the mounting member of the tubular housing (130) to bond the second sub-assembly (102) to the first sub-assembly (101) such that the spring urges the double-ended needle (116) to move to the guard position during use. Finally, the method includes applying a label (124) to the closure on the open end of the container (170) to seal the medical needle device 110 within the container (170).

Description

Technical Field

[0001] The present invention relates to a method of assembling a safety needle device (assembly) and an assembly line process for assembling a safety needle device. In particular, the present invention relates to a method of assembling a safety needle device that provides a guard to impart automatic (passive) needlestick protection, and in particular, provides a pivoting / tilted mounted needle to prevent needlestick injuries at the non-patient end of the needle after use. Background Art

[0002] Needlestick injuries may be caused by the distal end of the needle used to pierce the skin. However, the proximal end of the needle is also sharp because it is used to pierce the elastomeric membrane and extend into the cartridge or container containing the liquid drug. Once the safety needle device (assembly) is removed from the injection device, the near non-patient end of the needle therefore brings further risks to the clinician or user. Therefore, the distal end of the safety needle assembly may include a protective device for the distal tip of the needle, and may also include a shield or skirt that provides certain protection for the proximal tip of the needle. In addition, the needle can be incorporated in the needle safety device so that the needle pivots / tilts when the safety needle device is disassembled from the medical syringe. In such a device, the proximal tip of the needle is positioned adjacent to or adjacent to the shield or skirt so that the fingertip cannot easily contact the proximal end of the needle tip.

[0003] In order to provide such needlestick safety protection as described above, the safety needle device requires a metal spring or multiple metal springs to actuate the guard and / or pivot / tilt the needle. When the safety needle device is assembled, these springs may need to be preloaded in compression and / or also tensioned in torsion. Obviously, the positioning and tensioning of these springs within these small safety devices is very complicated, and care must be taken not to damage the distal or proximal ends of the needles within these devices. Therefore, the use of metal springs is problematic and significantly increases costs and also reduces the pen needle assembly line speed. Such safety needle devices are usually mass-produced at very high speeds.

[0004] Furthermore, needle safety devices must be subjected to stringent quality checks due to the final use of the device. Therefore, assembly methods, and in particular pen needle assembly lines, utilize a large number of quality checks, including video inspections at each individual assembly stage. The greater the number of assembly steps, the greater the number of quality checks that need to be completed, which further increases assembly costs and reduces the speed of the assembly line.

[0005] The terms "use" or "during use" are used to cover the complete use of the safety needle device, such as the actions from attaching a medical syringe to the safety needle device and removing it from a container, then performing an injection on a patient, then detaching the safety needle device from the medical syringe, and finally discarding the safety needle device into a sharps waste container.

[0006] It is an object of the present invention to overcome at least one of the problems associated with the prior art, whether referred to herein or otherwise. Summary of the invention

[0007] According to a first aspect of the present invention, there is provided a method of assembling and packaging a medical needle device having a double-ended needle, the medical needle device comprising a container having a closed end and an open end to accommodate a spring-actuated safety needle device to provide passive needlestick protection to a non-patient end of the needle; and wherein the open end of the container receives a closure to maintain sterility within the container, the method comprising:

[0008] Perform the following separate steps:

[0009] (i) assembling a first subassembly comprising a telescoping device engaged within a container, wherein the telescoping device comprises a shield and a tubular housing, and wherein the tubular housing comprises:

[0010] (a) a mounting member on the inner surface to engage a mounting element of the needle mount; and

[0011] (b) spring means for urging the double ended needle to move to a shielding position during use in which the needle extends at an oblique angle relative to the longitudinal axis of the tubular housing to position the non-patient end of the needle adjacent to the inner wall of the tubular housing;

[0012] (ii) assembling a second subassembly by securing the double-ended needle within a needle mount, wherein the mounting element is disposed on an outer surface of the needle mount;

[0013] inserting the second subassembly into the tubular housing to secure the mounting element of the needle mount to the mounting member of the tubular housing, thereby coupling the second subassembly to the first subassembly such that the spring means urges the double ended needle into the shielding position during use;

[0014] A closure is applied to the open end of the container to seal the medical needle device within the container.

[0015] The assembly of the first subassembly may include securing a portion of the telescoping device within the open-ended container using an interference fit. The assembly of the first subassembly may include securing a portion of the guard within the open-ended container using an interference fit. The assembly of the first subassembly may include securing a portion of the tubular housing within the open-ended container using an interference fit.

[0016] The interference fit for releasably retaining the safety needle device within the open ended container may comprise a detent or cam profile formed within the container to interact with a portion of the telescoping device.

[0017] Preferably, the assembly of the first subassembly is performed on a first assembly line, and the assembly of the second subassembly is performed on a second assembly line. Preferably, the first subassembly is combined / coupled to the second subassembly on the second assembly line. Preferably, the first assembly line is separate and / or different from the second assembly line. The first assembly line and the second assembly line may comprise parallel assembly lines. The first assembly line may be away from the second subassembly line. The method may comprise storing the first subassembly for a period of time before combining / coupling the first subassembly with the second subassembly. Therefore, the present invention solves the problem introduced by the "use-by" shelf life of such products, which begins with the fixing of the sterile barrier label on the open end of the container. For example, the completion of the first subassembly does not trigger the start of the shelf life. Such a first assembly can be assembled and stored at any location for a considerable period of time before use. This provides the opportunity to manufacture the first subassembly in countries with low manufacturing and storage costs. In addition, the final manufacturer can rest assured that they have the required number of complete first subassembly lines before running the second subassembly line. In addition, the speed of the second assembly line will not be affected (i.e., slowed down) by assembling the first subassembly and combining the first subassembly with the second subassembly in any way. Thus, the speed of the assembly line is affected by the speed of assembling the second subassembly and / or the speed of combining the first subassembly with the second subassembly.

[0018] The method may include transporting the first subassembly from a first assembly line to a second assembly line.

[0019] The method may include packaging a plurality of first subassemblies into bulk packages, transporting the bulk packaged items to a second assembly line, removing the first subassemblies from the bulk packages, and individually introducing each first subassembly into the second assembly line.

[0020] The method may include push-fitting the second subassembly into the first subassembly to join the first subassembly and the second subassembly together.

[0021] The joining of the first subassembly to the second subassembly may include relatively moving the first subassembly toward the second subassembly along the central longitudinal axis, and the joining may include the single linear movement.

[0022] Preferably, the method comprises aligning the first subassembly with the second subassembly. Preferably, this alignment only requires the alignment of the central longitudinal axis of the first subassembly and the second subassembly, and does not require (omit) any relative rotation radial alignment of the subassemblies around the corresponding central longitudinal axis to combine the two subassemblies together.

[0023] Preferably, the method comprises aligning a central longitudinal axis of the first subassembly with a central longitudinal axis of the second subassembly and then relatively moving the first subassembly towards the second subassembly only along the coinciding central longitudinal axes.

[0024] Preferably, the needle mount is rotatable about the central longitudinal axis so that the needle mount remains engageable within the mounting member in any relative rotational position.

[0025] Preferably, the mounting element is engageable within the mounting member at any relative rotational position relative to a central longitudinal axis of the needle mount (and / or second subassembly) and / or tubular housing (and / or first subassembly).

[0026] The needle mount may comprise a longitudinal axis, wherein the needle is arranged to extend along the longitudinal axis, wherein the needle mount is rotatable about the longitudinal axis whereby the mounting element remains engageable within the mounting member to articulate in any angular position / orientation about the longitudinal axis.

[0027] Preferably, the method includes tiltably mounting the needle mount within the tubular housing when the first subassembly is combined with the second subassembly.

[0028] Preferably, the method comprises maintaining the spring in an unloaded configuration when the first subassembly is combined with the second subassembly.Preferably, the spring is preloaded when the medical injector (pen injector) is attached to the safety needle device.

[0029] Assembling the first subassembly may include securing the tubular housing in the open-ended container using an interference fit.

[0030] Assembling the first subassembly may include forming (in a first assembly line) a telescoping device and then removably inserting the telescoping device into a container to form the first subassembly. The method may include push-fitting the telescoping device into the container. The method may include push-fitting the shield into the container. The method may include push-fitting the tubular housing into the container.

[0031] The method may include push-fitting the shield onto the tubular housing. The method may include push-fitting the shield into the tubular housing.

[0032] Joining the first subassembly with the second subassembly includes push-fitting the mounting element into the mounting member.

[0033] The method may include inserting the second subassembly into the first subassembly, wherein the subassemblies are in any relative rotational orientation about a central longitudinal axis. The central longitudinal axis may be defined by a central longitudinal axis of the first subassembly and a central longitudinal axis of the second subassembly, and the method may include moving these longitudinal axes so that they coincide.

[0034] The mounting element may comprise a contoured outer surface of the needle mount.

[0035] The mounting element may include a spherical outer surface of the needle mount that may facilitate a "ball and socket joint" with the mounting member. The shaped outer surface may include a curved outer surface (or any other surface / shape to allow a pivotal articulated connection between the first subassembly and the second subassembly). The shaped outer surface may include a partially spherical surface. The shaped outer surface may be uniform around the central longitudinal axis of the needle mount.

[0036] The method may include positioning the mounting element within the mounting member. The method may include pushing the mounting element into the mounting member, and may include pushing a contoured outer surface of the mounting element to position within a contoured inner surface of the mounting member such that the mounting element can articulate within the mounting member (and can move within the mounting member) while the mounting element is preferably retained within the inner contoured surface of the mounting member.

[0037] The method may include forming a connection between the mounting element and the mounting member to allow articulation, and / or to limit relative longitudinal movement between the first (first) subassembly and the second (second) subassembly.

[0038] The method may include positioning the first mounting element and the second mounting element within the first mounting member and the second mounting member, respectively. The first mounting element and the second mounting element may include a short shaft (and / or an axis lug). The method may include mounting the needle mount between a pair of mounting members. The mounting member may include a recess. The method may include mounting the needle mount to form a tiltable arrangement, as shown in GB2104342.7, GB 2108399.3 and GB 2201934.3.

[0039] The method may include mounting the needle mount between a first pair of mounting members and providing a second pair of mounting members, whereby the needle mount is mounted to be movable from the first pair of mounting members to the second pair of mounting members during use.

[0040] The method may include mounting the needle mount about an axis defined by a mounting element of the needle mount.

[0041] Preferably, the method comprises mounting the needle in an operating position, and mounting the spring and needle mount in a set position, after which use of the spring-actuated safety needle device with the medical syringe causes a displacement from the set position, the displacement enabling the spring to rotate the needle to the shielding position when the spring-actuated safety needle device is separated from the medical syringe. The method may comprise mounting the needle mount to form a tiltable arrangement, as shown in GB 2108399.3 and GB 2201934.3.

[0042] Preferably, the spring means comprises a resilient member extending inwardly from the tubular housing and contacting an outer surface of the needle mount at a position offset from the rotation axis and preferably applying a rotational force to rotate the needle mount.

[0043] Preferably, the spring comprises a leaf spring projecting inwardly from the tubular housing and the leaf spring is preloaded to deflect from a neutral / relaxed position when the needle is in the operative position. Preferably, the leaf spring has energy stored therein when the needle is in the operative position. An end surface of the leaf spring may contact an outer surface of the needle mount to generate a torque about the axis of rotation.

[0044] Preferably, the needle mount comprises an integral component having one or more integral mounting elements in the form of a shaped surface or axial member on the outer surface. The shaped outer surface may provide a spherical surface and may enable the needle mount to be fixed by a ball and socket arrangement and may enable a snap fit (ball and socket) arrangement. The axial member may provide a hemispherical surface and may enable the needle mount to be fixed by a ball and socket arrangement and may enable a "snap fit" (ball and socket) arrangement.

[0045] The tubular housing may include a mounting member in the form of an axial member on the inner surface for cooperating with an axial member provided on the needle mount. Preferably, the needle mount and the axial member of the tubular housing are such that the needle mount can be push-fitted into engagement with a pivot position within the axial member of the tubular housing. The method may include mounting the needle mount to form a tiltable arrangement as shown in GB 2104342.7, GB 2108399.3 and GB 2201934.3.

[0046] The tubular housing and the axial members of the needle mount may comprise a first pair of axial members and a second pair of axial members, the first pair of axial members comprising projections and the second pair of axial members comprising corresponding recesses. The projections may comprise hemispherical projections. The axial members may provide a ball joint. Preferably, the axial members provide a first ball joint on one side of the needle mount and a second ball joint on the opposite side of the needle mount for connection to a complementary ball joint provided in the tubular housing.

[0047] The open (proximal) end of the container may comprise the proximal end, and the closed end may comprise the distal end of the container. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] The present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0049] Figure 1 A schematic diagram of an assembly line of a prior art pen needle device.

[0050] Figure 2A and 2BSide and perspective views of a pen needle including a spring-actuated safety needle device in a pre-injection configuration.

[0051] Figure 3A and 3B Side and perspective views of a pen needle including a spring-actuated safety needle device in a configuration during an injection.

[0052] Figure 4A and Figure 4B Side and perspective views of a pen needle including a spring-actuated safety needle device in a post-injection configuration.

[0053] Figure 5 is a perspective view of a pen needle including a detachable spring-actuated safety needle device with the non-patient end of the needle in a shielded position.

[0054] Figure 6 Exploded view of the spring actuated safety needle assembly and assembly fixture.

[0055] Fig. 7A and Figure 7B Side and perspective views of a needle and needle mount positioned on an assembly fixture with an open ended container and spring actuated subassembly in a pre-assembled position.

[0056] Fig. 8A and Figure 8B Side and perspective views of a spring actuated safety needle device in an assembled position within an open ended container and positioned on an assembly fixture.

[0057] Fig. 9 A partial cross-sectional view of a preferred embodiment of a spring-actuated safety needle device before the first subassembly is coupled / joined with the second subassembly.

[0058] Fig.10 A partial cross-sectional view of a preferred embodiment of a spring-actuated safety needle device showing a first subassembly coupled / united to a second subassembly.

[0059] Fig.11 A partial cross-sectional view of a preferred embodiment of a spring-actuated safety needle device attached to a medical syringe prior to injection.

[0060] Fig.12 A partial cross-sectional view of a preferred embodiment of a spring-actuated safety needle device separated from a medical syringe in a state of use; and

[0061] Fig.13 Schematic diagram of a preferred embodiment of an assembly line for a spring actuated safety needle device. DETAILED DESCRIPTION

[0062] The assembly method and assembly line of the present invention are primarily, but not exclusively, intended for use with medical needles providing front and rear needlestick protection.Medical needles may be used to pierce the human or animal body, or may be used for other medical purposes, such as piercing a pierceable membrane of an intravenous drug system.

[0063] In the following description, all uses of the needle safety assembly will be described simply as body penetration, although specific embodiments may be intended for other uses.

[0064] Throughout this specification and with reference to the accompanying drawings, a safety needle device is shown and described herein that provides protection for the needle on a pen needle assembly, specifically on the non-patient (proximal) end and on the patient (distal) end. As used herein, the terms "distal" and / or "forward" or "forwardly" and their derivatives refer to a direction generally toward the patient end when in use, while the terms "proximal" and / or "rearwardly" or "rearwardly" and their derivatives are used to describe a direction away from the patient during use.

[0065] As shown and as will be described, the proximal end of the safety needle device 110 can be attached to the distal end of a medical injector device 112. The distal end of the safety needle device 110 will be pressed against the patient's skin, and during an injection, the distal end of the medical injector device is away from the patient.

[0066] Such a safety needle device 110 includes a spring or multiple springs to push the shield member and / or move the needle 116 for safety reasons to provide needle stick protection. Specifically, when the shield is pressed against the patient's skin, the shield 114 can slide back during an injection to expose the patient end of the needle 116. When removed from the patient's skin, the (inner) shield 114 can then be moved to a shielding position, which prevents access to the patient's (distal) end of the needle 116 after the injection.

[0067] Alternatively or additionally, the safety needle device 110 may be in the form of a spring-actuated safety needle device 110, which further includes a spring (not shown) to push the needle mount 140 and subsequently move the needle mount 140 when the spring-actuated safety needle device 110 is disengaged from the medical injection device 112. The spring moves the non-patient end 118 of the needle 116 specifically to the shielding position, whereby the non-patient end 118 of the needle 116 is positioned adjacent to or abutting the wall of the tubular housing 130.

[0068] The present invention can be used with a pen injector and will be described by way of example using it with a pen injector. The pen injector typically comprises a medical injector device 112 including a dose adjustment mechanism for setting, for example, an insulin dose, and a safety needle device 110 for insertion into a patient to allow correct drug administration. The pen comprises a disposable safety needle and is removed and discarded after each administration.

[0069] The pen needle is a double-ended needle 116 and includes a patient end 119 or a distal end including a sharp tip for insertion into a patient's body. The double-ended needle 116 also includes a non-patient end 118 or proximal end, which includes a sharp tip for insertion into a vial or cartridge provided by the pen injector 112. The proximal / non-patient end 118 of the needle 116 typically has a piercing rubber or elastomeric seal 111, which may include a septum or stopper disposed on the end of the vial or cartridge to access the liquid medicament or drug contained in the cartridge. A spring-actuated safety needle device 110 has been developed to protect the distal or patient end 119 of the needle 116 to prevent unintentional "needle sticks" after use. In addition, a spring-actuated safety needle device 110 has been developed to protect the proximal or non-patient end 118 of the needle 116 after separation from the medical injector device 112 to prevent unintentional "needle sticks" after use.

[0070] refer to Figure 1 , a typical standard pen needle assembly line shows the assembly of a standard pen needle 16 , which includes a shield 14 (inner shield) to protect the distal end or patient end 19 of the needle 16 .

[0071] First, the needle hub 20 is oriented and placed on the assembly fixture 22. The needle hub 20 includes a needle mount upright 21, and this can be prepared for gluing using a plasma jet to improve the adhesion of the adhesive. The needle 16 is then oriented so that the patient end 19 of the needle 16 points upward. The patient end 19 of the needle 16 is sharpened to typically have three bevels, while the non-patient end 18 is sharpened to typically have a single bevel. The needle 16 is then glued and the glue is then cured and hardened into the upright needle mount 21 of the needle hub 20 using heat or ultraviolet light.

[0072] The distal and proximal ends of the needle 16 are then silicone coated to lubricate the needle 16, and the air pressure / flow to the needle 16 is checked to ensure that the needle 16 is not blocked. The needle 16 and needle hub 20 combination is video checked to ensure that the needle 16 is properly positioned and vertically positioned relative to the needle mount 21 and needle hub 20, and to ensure that no damage has occurred to the needle end. Thereafter, the shield 14 is oriented and carefully placed over the needle 16, and the shield 14 is secured to the upright portion 21 of the needle mount 20 using a press-fit friction arrangement. Again, the shield 14 and needle 16 can be video checked. This may require a camera to view through the shield 14 to again ensure that the needle 16 has not been damaged in any way during the placement of the shield 14 over the needle 16.

[0073] The open-ended container 70 is oriented and then placed on the shield 14 and on the needle hub 20. The open-ended container 70 is secured by a press-fit friction device around the periphery of the needle hub 20. The completed assembly is then transferred and positioned into another assembly fixture 23. In this position, a peeler tamper-proof barrier label 24 is sealed on the end face of the open-ended container 70, which has been printed with an expiration date related to the use-by date of the packaged product. The label 24 can be folded down and heat-sealed or glued / adhered to the side of the open-ended container 70. Finally, the completed pen needle package 80 is packaged, typically in boxes of 100, and sterilized using gamma radiation or with ethylene oxide gas. High temperature dry heat can also be used as a sterilization process.

[0074] As mentioned above, the assembly of a simple pen needle involves multiple steps and may require multiple verification checks after each step or at least specific steps involving the insertion / placement of the needle. Thus, the assembly process is complex and this may limit the speed of operation.

[0075] In particular, the present invention relates to an improved assembly method for a spring-actuated safety needle device 110. Such a device 110 is more complex than the simple pen needle 10 described above due to the further complexity of inserting and assembling complex plastic components and positioning and tensioning the spring within the device 110, and it is important to avoid damage to the needle 116 and other components during assembly.

[0076] The present invention provides a method by which the subassembly 101 is first assembled and then introduced into the assembly line 100, thereby simplifying and compressing the assembly line and method. The subassembly 101 includes an open-ended container 170, a tubular housing 130, a shield 114, a spring (not shown), and a mounting device for a needle mount 140.

[0077] In brief, the present invention provides an assembly line 100 whereby a needle 116 is secured within a needle mount 140. The needle mount 140 is then mounted to the prepared subassembly 101 in a single step. Finally, as with the simple pen needle assembly line of the prior art, a label 124 can be sealed on the open face of an open-ended container 170. Overall, the pre-assembled subassembly 101 significantly simplifies the process, so that the assembly line 100 requires less inspection, thereby improving the reliability and speed of the process. The needle mount 140 provides a push-fit arrangement whereby the needle mount 140 is correctly positioned within the mounting device in a single action. In addition, the tensioning of the spring is automatically performed by the positional arrangement of the needle mount 140 within the tubular housing 130. The mounting device provides a first relative positional relationship between the needle mount 140 and the spring 150 and a second relative positional relationship between the needle mount 140 and the spring 150.

[0078] Figures 9 to 12 A preferred embodiment of a spring actuated safety needle device 110 is shown. The needle mount 140 is positioned in a fixed position within the tubular housing 130, and the spring 150 is positioned on an inner sleeve portion 152, which is movable within the tubular housing 130.

[0079] Prior to inserting the needle mount 140 (see Fig. 9 ), it will be readily appreciated that the inner sleeve portion 152 is held in position relative to the tubular housing 130 so as to retain the inner sleeve portion 152 within the tubular housing 130. This positional arrangement may be maintained using a suitable arrangement, such as frictional resistance between the inner sleeve portion 152 and the tubular housing 130, a latching mechanism on the inner sleeve portion 152 and the tubular housing 130, mutual protrusions / recesses, detents, etc. The tubular housing provides two axially opposed recesses 142 (mounting members) which hold the needle mount 140 in a fixed longitudinal position but enable the needle mount 140 to articulate within the mounting members 142. This mounting arrangement provides a ball and socket type joint. When the first subassembly is coupled / joined to the second subassembly (such as Fig.10 In the (shown) position, the needle is held by the blocking member 144 along the central longitudinal axis.

[0080] Attachment of the safety needle device 110 to the medical syringe 112 causes the spring 150 (mounted on the inner sleeve portion 152) to move distally relative to the needle mount 140 so as to load the spring 150, such as Fig.11 . Specifically, the attachment of the safety needle device 110 to the medical syringe 112 causes the spring 150 and the needle mount 140 to move from the set position (to the active position). In particular, when partially attached, the proximal end of the inner sleeve portion 152 abuts and contacts the distal end of the medical syringe 112. Then, the inner sleeve portion 152 is prevented from moving further toward the medical syringe 112, but further attachment causes the tubular housing 130 to move toward the medical syringe 112. Therefore, the tip of the spring 150 moves toward the flange 136 and abuts the flange 136 and the spring 150 is loaded to generate a rotational force on the needle mount 140.

[0081] After the safety needle device is attached to the medical syringe and the spring 150 is subsequently loaded, an injection is performed and the shield 114 (outer shield) moves or moves distally back to the protection position. During the injection process, the blocking device 144 (control member) moves distally and remains at the distal end of the shield 114. In this position, the blocking device 144 no longer holds the needle 116 along the central longitudinal axis. In this position, the spring 150 pushes the needle mount 140 to rotate, but this is offset by the engagement of the non-patient end 118 with the rubber seal 111.

[0082] The subsequent separation of the safety needle device 110 from the medical syringe 112 releases the reactive engagement, such as Fig.12 As shown. Specifically, the non-patient end 118 is released from the rubber seal 111 and the needle mount 140 is immediately rotated due to the loading of the spring 150. The needle 116 moves away from the alignment with the central longitudinal axis, and the non-patient end 118 is withdrawn into the tubular housing 130 and is positioned / adjoined to the inner surface of the tubular housing 130 in a safe state. It is easy to understand that the inner sleeve portion 152 is kept in place relative to the needle mount 140 so as to maintain the urging force applied by the spring on the flange 136. Any suitable arrangement can be used to maintain the inner sleeve portion 152 in place, such as friction resistance between the inner sleeve portion 152 and the tubular housing 130, a latch mechanism, mutually complementary protrusions / notches / detents or cam profiles on the inner sleeve portion 152 and the tubular housing 130, etc. By confirming the manner, the transition from the set position (to the working position) is permanent to ensure that the needle 116 moves to the protective position when the safety needle device 110 is separated from the medical syringe 112. Thus, frictional contact (as shown in the figures) or some other means would be required to retain and maintain the inner sleeve portion 152 within the tubular housing 130 in the active position after use.

[0083] In an alternative embodiment, the needle mount 140 is initially installed (the spring 150 is not loaded), and the action of fixing the safety needle device 110 to the medical syringe 112 can move the needle mount 140 (rather than the inner sleeve 152) to the second position, thereby generating the necessary spring force. When the safety needle device 110 is separated from the medical syringe 112, the force generates a pushing action to subsequently tilt / pivot the needle 116, and this provides a passive (automatic) needlestick protection of the non-patient end 118 of the needle 116. In some embodiments, the spring 150 can be preloaded when the first subassembly 101 is combined / connected to the second subassembly 102. However, if a plastic spring is used, such an embodiment may suffer degradation during storage and before use. For example, when the needle mount 140 is located in the mounting device, the spring 150 can be tightened. The method may include installing the needle mount to form a tiltable arrangement as shown in any one of GB2104342.7, GB 2108399.3 and GB 2201934.3.

[0084] The safety pen needle assembly 110 and the medical syringe device 112 are Figure 2A and 2B to Figure 5, and a syringe 108 in the form of a medical pen or pen-type syringe is provided. The medical syringe device 112 includes a cartridge 106 containing a medicament / fluid, and specifically, the cartridge 106 contains a certain volume of liquid medicament. The spring-actuated safety needle device 110 includes a needle seat or tubular housing 130, a needle 116 and a protective sleeve 114. The tubular housing 130 includes a body 131 having a distal end 132 and a proximal end 134. The proximal end 134 is formed with an open face open and shaped to receive a portion of the syringe device 112 to allow the spring-actuated safety needle device 110 to be attached to the syringe device 112. The spring-actuated safety needle device 110 can be mounted to the syringe device 112 using threads or surface configurations, such as a tapered surface for a luer-type mounting, or both. The needle 116 can be any needle design, in particular any pen needle design. For purposes of describing the present invention, the term needle 116 will be used, although it may be replaced by the term cannula, which may more specifically refer to the double-ended needle 116 of the safety needle device 10. The needle 116 includes a distal end 118 formed for insertion into a patient, and has a proximal end 119. The needle 116 is mounted within a needle mount 140 and may be secured therein using any known technique, such as adhesively secured to the needle mount 140.

[0085] The spring-actuated safety needle device 110 provides passive needlestick protection (which does not require user intervention) to the non-patient end 118 of the needle 116. Specifically, the device 110 provides a mechanism whereby the non-patient end 118 of the needle 116 automatically moves to the protection position after use. Specifically, the needle mount 140 is movably (pivotably / tiltably) retained in the tubular housing 130 to move from an axially aligned position (relative to the longitudinal axis of the tubular housing 130) to an angle of inclination relative to the longitudinal axis of the tubular housing 130 so that the non-patient end 118 of the needle 116 is positioned adjacent to or adjacent to the inner wall of the tubular housing 130. In some embodiments, this safety tilting movement occurs when the safety needle device 110 is disassembled for the medical syringe device. In short, the needle 116 is retained along the longitudinal axis by the initial retention mechanism. When the safety needle device 110 is attached to the medical syringe device 112, the non-patient proximal end 118 of the needle 116 pierces the seal 111, thereby also retaining and maintaining the needle 116 along the longitudinal axis. During use before the safety needle device 110 is separated from the pen injector, the initial retention mechanism is (automatically) released. Therefore, during separation, the needle 116 is withdrawn from the seal 111 and the push device moves the non-patient end 118 of the needle 116 to the protection position.

[0086] The operating sequence of the spring-actuated safety needle device 110 is shown in FIGS. Figure 52, the needle device 110 is shown attached to the medical syringe device 112 and the front guard member 114 is in the forward (distal) position, thereby protecting the patient end 119 of the needle 116. During the injection (as shown in FIG. 3), the patient's skin (not shown) causes the front guard member 114 to retract and the patient end 119 of the needle 116 will penetrate to the depth required for the injection. When the syringe device 108 is removed from the patient, the front guard member 114 moves forward again to protect the front distal end (tip) 119 of the needle 116, as shown in FIG. 4. Finally, the safety needle device 110 is removed from the medical syringe device 112, as shown in FIG. Figure 5 shown. Figure 5 The needle 116 is shown angled to provide passive needlestick protection for the non-patient end 118 of the needle 116. Figure 5 As shown, the non-patient end 118 of the needle 116 is located within the tubular housing 130 and is located adjacent to or abutting the inner wall of the tubular housing 130 .

[0087] The safety needle device 110 requires an urging means (not shown) in the form of a spring in order to specifically move the non-patient end 118 of the needle 116 to the protected position. The positioning and mounting arrangements required to provide such movement for these small devices are complex and require precise assembly. This therefore creates problems due to the additional time, cost and steps required in the assembly process. As previously mentioned, the assembly line and process speed of the safety needle device is very high and requires a large number of verification checks between assembly steps. The present invention seeks to address these problems and provides a method involving the formation of two sub-assemblies, which are then combined to create a needle safety device, thereby significantly speeding up the process and minimizing the number of separate verification steps.

[0088] Fig.13 A preferred embodiment of an assembly line 100 (second assembly line) is shown, showing the packaging of a spring-actuated needle device 110 in a sealed container, wherein a first subassembly is provided and introduced into the assembly line. The spring-actuated needle device 110 includes a shield 114 for shielding a distal end or patient end 119 of a needle 116 and a tilt mechanism for providing passive needlestick protection to a non-patient end 118 of the needle 116.

[0089] In a first process or first assembly line (not shown), a first subassembly 101 is formed, which consists of a tubular housing 130, a front guard member 114 and an open-ended container 170. The tubular housing 130 and the guard member 114 form a telescoping device 104, and the telescoping device can be assembled in a simple process and simply inserted into the container 170, such as Figure 6As shown. Such assembly is simple and can be quickly achieved by push fit / interference fit. For example, the outer surface of the telescoping device 104 engages with the inner surface of the container 170. In some embodiments (see Figures 2-6), the tubular housing 130 has a larger circumference than the inner shield 114, so the tubular housing 130 engages with the inner surface of the container 170 to engage the telescoping device 104 in the container 170. In other embodiments with an outer shield 114 (see Figure 9-12 ), the shield 114 has a larger outer circumference than the tubular shell 130, so the shield 114 engages with the inner surface of the container 170 to hold the telescopic device 104 to the container 170.

[0090] Alternatively, the shield 114 may be inserted into the container 170 first, and then the tubular housing 130 may be inserted into the shield 114. In some embodiments, the shield 114 is located on a portion of the outer surface of the tubular housing 130 and slides thereon (e.g., Figure 9-12 2-6). The inner surface of the container 170 is engaged with the telescopic device 104 by engaging with the tubular housing 130 or the shield 114.

[0091] Fig.13 Steps in AD are similar to Figure 1 , and in the present invention, the intent is to form the second subassembly 102 in an initial portion of this second assembly line. The needle mount 140 is oriented and placed into the assembly fixture 122. In some embodiments, the needle mount 140 may be prepared or ready for gluing using a plasma jet in order to improve the adhesion of the adhesive. The needle 116 is oriented so that the patient end 119 of the needle 116 protrudes upward, and the needle 116 is placed into the needle mount 140, specifically through a central opening in the needle mount 140. The non-patient end 118 of the needle is sharpened to have a single bevel end, for example, while the patient end 119 has three bevels. As Fig. 9 As shown in schematic step D of , the needle 116 is glued and UV light or heat is used to cure and harden the adhesive into the needle mount 140 .

[0092] The distal and proximal ends of the needle 116 are then coated with silicone for lubrication purposes. The air pressure / flow to the needle 116 is checked to ensure that the needle 116 is not blocked. The needle 116 and needle mount 140 are video checked to ensure that the needle 116 is positioned vertically in the needle mount 140 and also to ensure that the needle tip is not damaged. The combination of the needle mount 140 and the needle 116 forms the second subassembly 102 of the present invention.

[0093] As described above, according to the first separate / parallel process, the first subassembly 101 is formed in the first separate / parallel assembly line, and the first subassembly is composed of a tubular shell 130 and a protective member 114, and they are positioned in an open-ended container 170. The combination of the tubular shell 130 and the protective member 114 forms the telescopic device 104, and it can be simply inserted into the container 170 in a simple process. This assembly is simple and can be quickly achieved by a push-fit / interference fit or a latch type arrangement. For example, the outer surface of the telescopic device 104 engages with the inner surface of the container 170. The first subassembly 101 can be formed at a location away from the second assembly line and in a separate remote facility. At the end of the first assembly line, the first subassembly can be bulk packaged and then transported to the location of the second assembly line, or the first (1 st ) and the second (2 nd ) subassembly process is carried out at the same location. Then, Fig.13 As shown in the schematic diagram of step E in FIG. 1 , the first subassembly can be unpacked and inserted into the second assembly line. Such packaged sterilized medical products generally have a 5-year shelf life associated with the product launch date, which is packaged and sterilized. Each peel-off closure label is date printed during the second assembly line process. Therefore, it is advantageous to introduce the first subassembly into the second assembly line only when needed (in time), because the products coming out of the second assembly line are destined to be destroyed within 5 years if they are not purchased and used during this period.

[0094] The first subassembly 101 is oriented relative to the second subassembly 102, such as Fig.13 Schematic step E of Fig. 7A and Figure 7B as well as Figure 6 (shown in exploded view). The tubular housing 130 provides a spring to produce a tilting motion for passive needlestick protection of the non-patient end 118 of the needle 116. The spring can be an integral part of the tubular housing 130 and can include a resilient finger. Since the needle mount 140 (of the subassembly 102) does not form part of the first subassembly 101, the spring is in an unloaded configuration in the first subassembly 101. In some preferred embodiments, the spring is provided by a leaf spring / elastic member protruding from the tubular housing 130. The tubular housing 130 provides one or more mounting elements on an inner surface, which are arranged to engage one or more mounting elements on the needle mount 140.

[0095] In a preferred embodiment, the needle mount 140 includes a shaped outer surface 141 (mounting element) that is engageable within a shaped inner surface (mounting member) provided by the tubular housing 130. Specifically, the shaped outer surface and the shaped inner surface form a ball joint so that the needle mount 140 is axially mounted within the tubular housing. Specifically, the needle 116 is tiltably / pivotally mounted within the tubular housing 130 and is movable from an operative position to a shielding position, in which the needle 116 extends at an angle oblique to the longitudinal axis of the tubular housing 130 to place the non-patient end 118 of the needle 116 at a position adjacent to the inner wall of the tubular housing 130. The needle 116 is initially retained by a blocking device (not shown) in the operative position, in which the needle 116 extends in a direction along the longitudinal axis of the tubular housing 130, and release of the blocking device thereby allows the needle 116 to move to the shielding position.

[0096] In a preferred embodiment, the shaped outer surface 141 of the mounting element is provided to provide a uniformly shaped surface so that the needle mount 140 can be inserted into the tubular housing 130 at any rotational radial position around the central longitudinal axis. For example, the second subassembly 102 forming the combination of the needle 116 and the needle mount 140 has a central longitudinal axis, and the tubular housing 130 of the first subassembly 101 also has a central longitudinal axis. Initially, the first subassembly 101 is oriented so that the central longitudinal axis coincides with the central longitudinal axis of the needle 116 and the mounting member 140 of the second subassembly 102. Then the second subassembly 102 can be simply inserted into the first subassembly 102, only by moving relative linear motion in the direction of these coincident longitudinal axes. Specifically, neither the first subassembly 101 nor the second subassembly 102 needs to be twisted / rotated to a precise radial position around the central longitudinal axis because the mounting element / mounting member does not need a fixed relative rotational position as in the case of some mounting arrangements. Thus, the ball and socket attachment provided by some preferred embodiments of the two subassemblies simplifies the assembly process.

[0097] However, in some embodiments, the tubular housing 130 provides two axial recesses for receiving two shaft ends protruding outwardly from the needle mount 140. When the shaft ends are engaged in the axial recesses of the needle mount 140, the needle mount 140 is in an active position in the safety needle device 110. In some embodiments, the shaft ends may be offset from the longitudinal axis of the needle mount 140.

[0098] In some embodiments of the safety needle device 110, the tubular housing 130 is provided with a single pair of mounting elements so that the needle mount 140 is maintained in a fixed axis relative to the tubular housing 130. Specifically, the shaft mounting member for the tubular housing 130 forms a single fixed axis around which the needle mount 140 can be pivoted or tilted. However, in some other embodiments, the tubular housing 130 may provide two pairs of mounting elements, whereby the needle mount 140 is initially engaged in the first pair of mounting elements. When engaged in the first pair of mounting elements, the spring is maintained in an unloaded position. This can help maintain elastic quality and prevent the safety needle device 110 from being damaged before use. The needle mount 140 is arranged to move to the second pair of mounting elements during use. For example, when the safety needle device 110 is attached to the medical syringe device 112, the needle mount 140 moves from the first pair of mounting elements to the second pair of mounting elements, thereby loading the spring and generating a motive force to subsequently pivot or tilt the needle 116 to the protective position.

[0099] It should be understood that quickly positioning and orienting a metal compression spring into multiple complex plastic components may easily damage either end of the needle, and this is even more likely to occur when manufacturing a safety needle assembly 110 with a rear end (non-patient end) needlestick protection, in which a small spring element is arranged to move the needle to the needle protection position after use. At present, for this reason, the safety needle assembly 110 including the spring element is assembled on a single assembly line, where the component parts are sequentially introduced one at a time and have an intervention process and verification step. For example, as with the prior art safety needle assembly including a spring for the front protection member of the patient end of the needle, the unloaded coil spring is usually carefully positioned around the delicate needle tip during manufacturing. The needle passing through the central opening of the coil spring is complicated and provides a high risk of damaging the needle. In addition, some designs require a torsional preload winding of the spring to make the safety device work, which further complicates the assembly process of these types of devices. After this step, before the actual protection member and the loading spring are fixed, a verification step is required. The present invention provides the formation of a first subassembly 101, which contains a spring in a static position within a larger first subassembly 101. If the safety needle device 110 has a front protective member 114, the corresponding spring for this is already in a loaded configuration and is statically maintained within a larger open container 170. The first subassembly 101 also provides a spring element for rear end protection, which in a preferred embodiment is not a coil spring, so the needle 116 does not need to pass through the delicate step of the central channel of the coil spring. Overall, the formation of the first subassembly 101 produces a large and relatively sturdy assembly 101 for easily inserting a second subassembly 102 including a precision needle 116. Once engaged or coupled together, the complete safety needle device 110 is formed and can complete the final packaging stage.

[0100] As shown in Figure 8 and Fig. 9 As shown in step F of , the second subassembly 102 is positioned and secured within the first subassembly 101. As previously described, this coupling action correctly positions the spring for the rear end needlestick protection device because the tubular housing 130 provides a fixed mounting location for the second subassembly 102, whereby the spring is correctly positioned relative to the needle mount 140. Specifically, the open-ended container 170, which contains the other components of the first subassembly 101, is oriented and placed on the needle mount 140, and is press-fitted downward to position the needle mount 140 in the operating position of the tiltable safety needle device 110. Video inspection can now be used to see through the transparent open-ended container 170 to ensure that the needle 116 is not damaged during the process of assembling the two subassemblies 101, 102 together.

[0101] In this configuration, the safety needle device 110 is complete and self-supporting, but is retained within the open-ended container 170 by an interference fit or similar arrangement. This arrangement enables the safety needle device 110 to be easily removed from the open-ended container 170 for use by an end user.

[0102] Once the first subassembly 101 has been coupled to the second subassembly 102, the outer container can be completed. Initially, as shown in step G, the assembly is inverted and held in the second assembly fixture 123. In this orientation, the open end of the container 170 faces upward. This enables the cover label 124 to be sealed on the open face to complete the container. Specifically, a peelable use date label 124 with a date mark is sealed on the open face. The label also provides a kind of "tamper evidence" to confirm that the sealed container has not been opened.

[0103] like Fig. 9 As shown in step I of , in this case, a portion of the label 124 has been folded down and adhered to the side of the container 170. Specifically, the pull tab 125 of the label 124 is heat sealed or bonded to the side of the container 170.

[0104] Finally, the assembly 180 is packaged (typically in boxes or cartons of 100) and subsequently sterilized using gamma radiation or ethylene oxide (ETO) gas. High temperature (dry heat) can also be used as a sterilization process.

[0105] As previously mentioned, the term "use" or "during use" is used to cover the complete use of the safety needle device, such as the actions of attaching a medical syringe to the safety needle device and removing it from a container, then injecting the patient, then detaching the safety needle device from the medical syringe, and finally discarding the safety needle device into a sharps waste container.

Claims

1. A method of assembling and packaging a medical needle device having a double-ended needle, the medical needle device comprising a container having a closed end and an open end to accommodate a spring-actuated safety needle device to provide passive needlestick protection for the non-patient end of the needle; and wherein the open end of the container receives a closure to maintain sterility within the container, the method comprising: Perform independent steps: (i) assembling a first subassembly comprising a telescoping device engaged within the container, wherein the telescoping device comprises a shield and a tubular housing, and wherein the tubular housing comprises: (a) a mounting member on the inner surface to engage a mounting element of the needle mount; and (b) spring means for urging the double ended needle to a shielding position during use in which the needle extends at an angle oblique to the longitudinal axis of the tubular housing to position the non-patient end of the needle adjacent to an inner wall of the tubular housing; (ii) assembling a second subassembly by securing a double-ended needle in the needle mount, wherein the mounting element is disposed on an outer surface of the needle mount; Inserting the second subassembly into the tubular housing to secure the mounting element of the needle mount to the mounting member of the tubular housing, thereby coupling the second subassembly to the first subassembly so that the spring device can urge the double-ended needle to move to the shielding position during use; A closure is applied to the open end of the container to seal the medical needle device within the container.

2. The method of assembling and packaging a medical needle device according to claim 1, characterized in that: The assembly of the first subassembly is performed on a first assembly line, and the assembly of the second subassembly is performed on a second assembly line.

3. The method of assembling and packaging a medical needle device according to claim 2, characterized in that: The first subassembly is combined with the second subassembly on the second assembly line.

4. The method of assembling and packaging a medical needle device according to claim 2 or claim 3, characterized in that: The first assembly line is separate and different from the second assembly line.

5. The method of assembling and packaging a medical needle device according to any one of claims 2 to 4, characterized in that: The first sub-assembly line is remote from the second sub-assembly line, and the method includes transporting the first sub-assembly from the first sub-assembly line to the second sub-assembly line.

6. The method of assembling and packaging a medical needle device according to claim 5, characterized in that: The method includes packaging a plurality of first subassemblies into packages, transporting the packages to the second assembly line, removing the first subassemblies from the packages and individually separating the first subassemblies from each package, and introducing the first subassemblies into the second assembly line.

7. A method of assembling and packaging a medical needle device according to any preceding claim, characterised in that The method includes push-fitting the second subassembly into the first subassembly to join the first and second subassemblies together.

8. A method of assembling and packaging a medical needle device according to any preceding claim, characterised in that The coupling of the first subassembly to the second subassembly may include moving the first subassembly relative to the second subassembly along the central longitudinal axis and the coupling may include a single linear motion.

9. A method of assembling and packaging a medical needle device according to any preceding claim, characterised in that The method comprises aligning the first subassembly with the second subassembly, wherein the alignment requires only alignment of central longitudinal axes of the first and second subassemblies and omits any relative rotational alignment of the subassemblies about respective central longitudinal axes.

10. A method of assembling and packaging a medical needle device according to any preceding claim, characterised in that The method includes aligning the central longitudinal axis of the first subassembly with the central longitudinal axis of the second subassembly and then independently moving the first subassembly relative to the second subassembly along the coincident central longitudinal axes.

11. A method of assembling and packaging a medical needle device according to any preceding claim, characterised in that The needle mount is rotatable about the central longitudinal axis so that the needle mount remains engageable within the mounting member at any relative rotational position.

12. A method of assembling and packaging a medical needle device according to any preceding claim, characterised in that The method includes tiltably mounting the needle mount within the tubular housing when the first subassembly is combined with the second subassembly.

13. A method of assembling and packaging a medical needle device according to any preceding claim, characterised in that The method includes preloading the spring when the first subassembly is coupled to the second subassembly.

14. A method of assembling and packaging a medical needle device according to any preceding claim, characterised in that Assembly of the first subassembly includes securing the tubular housing in an open-ended container using an interference fit.

15. A method of assembling and packaging a medical needle device according to any preceding claim, characterised in that The assembly of the first subassembly includes forming the telescopic device and then removably inserting the telescopic device into the container to form the first subassembly, wherein the method includes push-fitting the telescopic device into the container.

16. A method of assembling and packaging a medical needle device according to any preceding claim, characterised in that The joining of the first subassembly to the second subassembly includes push-fitting the mounting element into the mounting member.

17. A method of assembling and packaging a medical needle device according to any preceding claim, characterised in that The method includes inserting the second subassembly into the first subassembly with the subassemblies in any relative rotational orientation about the central longitudinal axis.

18. A method of assembling and packaging a medical needle device according to any preceding claim, characterised in that The mounting element includes a spherical outer surface of the needle mount, the spherical outer surface facilitating a ball and socket joint with the mounting member.

19. A method of assembling and packaging a medical needle device according to any one of claims 1 to 17, characterized in that: The method includes positioning a first mounting element and a second mounting element within a first mounting member and a second mounting member, respectively.

20. A method of assembling and packaging a medical needle device according to any preceding claim, characterised in that The method comprises installing the needle in an operating position and installing the spring and the needle mount in a set position, after which use of the spring-actuated safety needle device and the medical syringe causes a displacement from the set position, and when the spring-actuated safety needle device is separated from the medical syringe, the displacement causes the spring to rotate the needle to a protective position.

21. A method of assembling and packaging a medical needle device according to any preceding claim, characterised in that The spring device includes an elastic member extending inwardly from the tubular housing and contacting the outer surface of the needle mount at a position offset from the rotation axis and applying a rotational force to rotate the needle mount.

22. A method of assembling and packaging a medical needle device according to any preceding claim, characterised in that The spring includes a leaf spring projecting inwardly from the tubular housing, and when the needle is in the operative position, the leaf spring is in a preloaded state and deflectable from a neutral / relaxed position.

23. A method of assembling and packaging a medical needle device according to any preceding claim, characterised in that The needle mount comprises a unitary component having one or more unitary mounting elements in the form of a shaped surface or axial member located on an outer surface.

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