Packaged needle assembly

Abstract

The present disclosure relates to medical devices, and more particularly, to a hard cartridge packaging product, a packaging product, and a packaging method for aseptic packaging of needle assemblies. The hard shell product comprises a box (2) and a cover (3) configured to define, in an engaged state, an enclosure (4) for the needle assembly (100), thereby forming one or more radial channels extending in a longitudinal direction between overlapping side wall sections and providing a gas passage to the enclosed volume. In a preferred embodiment, the cover comprises at least a first cover portion (31) and a second cover portion (32), the first cover portion and the second cover portion being connected by one or more interconnection members (33) configured to break by displacing the second cover portion (32) relative to the box body (2), meanwhile, the connection between the first cover part (31) and the box body (2) is maintained.

Description

Technical Field

[0001] The present invention generally relates to medical devices, and more particularly, to a hard box packaging product, a packaging product, and a packaging method for sterile packaging of a needle assembly for a medical injection device. Background Art

[0002] Safety needle assembly is well known and widely used. Usually, the safety needle assembly comprises a hub having a proximal end for connection with a syringe. Before use, the assembly is stored in a package under sterile conditions.

[0003] Blister packaging solutions are well known. In use, the user (e.g., a caregiver) partially opens the blister to release the hub, then holds the assembly at the packaging to connect the hub to the syringe to avoid contamination of the needle assembly or possible sterility breach. The user then further removes the packaging to release the safety needle assembly. This process is quite complex and can be prone to user error.

[0004] Although capable of storing sterile products, blister packs are generally not compatible with high-speed automated packaging processes. For example, blister packs include flexible or deformable portions that are difficult to be grasped by automated picking or assembly tools. In addition, blister packs may be easily deformed or damaged due to automated handling, making the packaging process generally slow and / or requiring one or more manual handling steps. In addition, blister packs tend to be bulky, which is disadvantageous in terms of storage and transportation.

[0005] WO2016108869A1 describes an adsorbent container having a first member and a second member, which when attached form a closed container having a first interior space and a second interior space. EP0517121A2 shows a vented cap and capillary assembly, which includes a capillary and a cap, the capillary having a hole extending through the capillary, the cap slidably mounted to one end of the tube, and the cap having a vent groove to allow air to escape when in a specific position. US3149717A describes a needle container, wherein the cap fits tightly into the open hole of the hub to maintain sterility, and the front end of the closure extends well into the container hole to maintain sterility. US2002130100A1 discloses an injection molded assembly that can seal a threaded or non-threaded container using a double cap concept with a pressure-responsive convex seal.

[0006] Rigid box packaging of products can partially alleviate the disadvantages regarding machine processing. However, the relatively more rigid enclosure disadvantageously hinders sterilization of the packaged product by limiting access to radiation and / or fluid sterilants.

[0007] Additionally, and particularly for rigid case packaged products, there remains a need to provide tamper-evident packaging solutions to reassure the end user of product quality by indicating that the package has not been previously opened, and to assure the sterility of the product.

[0008] Therefore, there remains a need for packaging solutions that eliminate or at least mitigate one or more of the above disadvantages. Summary of the invention

[0009] Aspects of the present disclosure relate to a hard shell packaging product, and more particularly to a hard shell product for packaging a needle assembly.

[0010] As will be explained in more detail below, a packaged product as described herein advantageously provides a relatively compact packaged product; provides improved automated machine handling characteristics; provides improved user convenience, for example in connecting a syringe to the hub; and / or includes anti-tampering measures; while enabling the packaged product to be sterilized by a gaseous sterilant.

[0011] The hard shell packaging product comprises at least a box body and a cover, and the box body and the cover are configured to engage with each other, preferably by sliding with each other at a pre-designed engagement distance, wherein the box body and the cover include circumferential overlapping side wall sections. The hard shell packaging product also includes one or more radial channels in an engaged state. The radial channel extends in a longitudinal direction between the overlapping side wall sections to provide one or more channels, and one or more channels allow or promote gas to pass to the packaged product contained in the closed volume defined by the cover and the box body. Providing a gas passage to the closed volume advantageously enables the packaged product (such as a needle assembly) to be sterilized. As will be described in detail below, the packaged product advantageously enables gas to approach the needle assembly to be sterilized by a gaseous agent, while the needle assembly is enclosed by the cover and the box body. Preferably, one or more channels form the only passage between the internal volume and the surrounding environment. By extending the channel between the inner surface of the cover and the outer surface of the box body (or vice versa) at a distance (e.g., a pre-designed engagement distance), the re-contamination of the needle assembly by airborne contaminants is alleviated.

[0012] Preferably, the hard shell packaging product includes one or more disposable devices for fixing the cover relative to the box body. The disposable fixture is irreversibly broken or deformed when the package is opened. Therefore, the disposable fixture provides a visual indication of destroying the sterile condition (e.g., by accidentally or without permission to pre-open the packaged product). As will be described in further detail herein, the disposable fixture can be implemented as a member of one or more pairs of mutual engagement (e.g., snap locks) arranged along the cover and the box body. Alternatively or additionally, the disposable fixture can be implemented as one or more interconnecting members (e.g., bridging members), which interconnect the corresponding parts of the hard shell packaging product and are irreversibly deformed (e.g., broken) when exceeding the threshold force and / or threshold strain. It should be understood that, advantageously, the disposable fixture can further prevent the cover and the box body from being reclosed or reassembled after the initial assembly.

[0013] The hard shell product is preferably implemented so that the cover includes at least two parts, at least two parts include a first cover part and a second cover part, the first cover part includes one or more devices for fixing to the box body; the second cover part is connected to the first cover part by one or more interconnecting members. The interconnecting member is configured to irreversibly break by displacing the second cover part relative to the box body, while maintaining the connection between the first cover part and the box body. Therefore, the package can be opened by removing the second cover part without releasing the first cover part from the box body. The remaining interconnecting means (broken or otherwise deformed) can advantageously provide a visual indication of removing the second cover part, while improving tamper resistance by preventing the packaged product from being reclosed once opened. In addition, one or more interconnecting members can advantageously limit the force required to open the package, such as torque and / or linear tension.

[0014] The first cover part, the second cover part and the interconnecting member are preferably integrally formed as a single piece, for example by injection molding. This reduces the possibility of tampering, relaxes manufacturing conditions, and / or reduces the total area of ​​the contact interface that may be blocked and cannot be accessed by the gaseous sterilant.

[0015] In a preferred embodiment, the overlapping side walls are spaced apart with a gap by one or more spacers. The spacers can advantageously define the cross section of the gap. The spacers also advantageously provide contact force and / or friction force between the cover and the box body to provide a tight or firm fit.

[0016] The spacer can be provided by one or more protrusions (e.g., one or more ribs, one or more nutshell-shaped portions, domes, or protrusions of other shapes), one or more protrusions extending from at least one of: an inner surface of an overlapping wall segment of the cover portion, the inner surface facing a corresponding overlapping wall segment of the box body; and an outer surface of a circumferential overlapping wall segment of the box body, the outer surface facing a corresponding wall segment of the cover portion.

[0017] Advantageously, overlapping wall sections may only be in contact with each other via one or more protrusions. This reduces the total area of ​​surfaces that are blocked from coming into contact with the gaseous sterilant (surfaces in flush contact).

[0018] In order to prevent or at least hinder the first cover member from being removed from the box body after initial assembly, one or more of the interconnecting members for fixing the first cover part to the box body may include interlocking elements, such as members configured to snap into a locked position, such as hooks and grooves, or one or more protrusions and corresponding socket members. Preventing or at least hindering the first cover member from being removed from the box body after initial assembly further improves tamper protection.

[0019] It will be appreciated that the interconnecting member is preferably configured to break at a force less than the breakaway force used to release the interlocking elements from the locked position.

[0020] Preferably, the box body is also configured to limit the rotational freedom of the needle assembly in the box body. The rotation of the needle assembly in the box body along the longitudinal axis (e.g., in the direction along the central axis of the box body) can hinder the attachment / coupling of the hub of the syringe and the needle assembly. In particular, limiting the rotation of the needle assembly in the box body can avoid user errors when the hub is configured to be connected to the syringe by rotation or tightening motion (e.g., Luer lock). The restricted rotational motion can be provided by the box body, which includes one or more engagement surfaces, and one or more engagement surfaces are configured to engage with one or more faces of the needle assembly (e.g., hub, barrel and / or needle guard). Therefore, the box body can be advantageously provided with one or more engagement members (e.g., grooves, husks or ribs), and the size and position of one or more engagement members are designed to engage with the outer surface of the needle assembly when rotating. Alternatively or additionally, the internal volume can be shaped to, for example, prevent the rotation of the needle assembly by a cross-sectional shape (e.g., rectangle).

[0021] In order to prevent, for example, one or more interconnecting members (such as bridges) that interconnect the first cover part and the second cover part from being accidentally damaged during the cover (machine) is assembled to the box body, the first cover part is preferably provided with one or more pushing or grasping members. The grasping or pushing member provides a contact point for the operator or the machine gripping portion to provide the force by which the cover is assembled to the box body. Usually, the grasping or pushing member extends outwards from the outer side of the first cover part. Alternatively or additionally, grasping can be provided by one or more grooves or trenches. Therefore, one or more grasping or pushing members protect the relatively fragile interconnecting member between the first part and the second part from being damaged during the cover is assembled to the box body.

[0022] Preferably, one or more push members overlap at least partially with the means for fixing the first cover part to the box body. Overlapping the push member with the means for fixing the first cover part to the box body limits access to the interlocking connection formed between the box body and the cover, and thus further enhances tamper protection.

[0023] To enhance external manual gripping (eg for disconnecting the lid from the case), one or more of the case and the second lid part (preferably both) may be provided with one or more external gripping members.

[0024] Alternatively or additionally, the hard shell packaging product preferably includes one or more retaining members, which limit the displacement of the needle assembly in the longitudinal direction in the box body. Even if the cover is in an open state, the retaining member also limits the needle assembly in the box body until the retaining force is exceeded (for example, the pulling force intentionally applied by the user exceeds the retaining force). Therefore, accidental falling can be avoided. The retaining member is usually arranged along the inner side wall (for example, the circumferential edge) of the box body, and the retaining member engages with the needle assembly.

[0025] As an alternative or supplement to one or more disposable devices for fixing the cover to the box body, an adhesive label can be applied. The label preferably fixes the corresponding part by extending circumferentially across the boundary between the cover and the box body and / or between the cover parts. Opening the packaged product will cause the label to tear. The tear mark formed is used as a visual indication that the hard shell packaged product is opened. In order to reduce the force required for the user to destroy the seal, the label preferably includes a plurality of perforated lines, which extend through the boundary between the cover and the box body. It is found that the provision of the perforated lines advantageously further increases the visibility of the tear mark.

[0026] Thus, in some embodiments, the packaged product includes a label adhered to the outer surface of both the box body and the cover, whereby the label has a dimension along a first direction such that the label spans at least a portion of the outer edge of the packaged product at the location of the gap, and whereby the label is dimensioned along a second direction to pass through the gap, thereby securing the box body relative to the cover, wherein the label includes a perforated section extending in a direction along the first dimension of the label, the perforated section including a plurality of perforated lines, the plurality of perforated lines being arranged at an oblique angle relative to the gap, the perforated lines having a first end and a second end, the first end terminating outside the edge of the box body at the base of the collar, and the second end terminating outside the edge of the cover across the gap. An angle of 20 to 40 degrees (preferably about 30 degrees) has been shown to provide optimal visibility of the tear mark while maintaining the overall structural integrity of the label, which enables automated application without premature tearing of the label.

[0027] Further or additional aspects relate to a cover and a box body (e.g., a kit) for assembling into a hard shell packaged product (e.g., the hard shell product disclosed herein for packaging a needle assembly), the cover and the box body defining a shell for the product to be stored in a connected configuration, wherein the box body and the cover are configured to provide circumferentially overlapping side wall segments in a connected configuration, and wherein one or more radial channels extending in a longitudinal direction between the overlapping side wall segments are provided to provide a gas passage to the needle assembly.

[0028] Preferably, and for the reasons described with respect to the packaged product, the cover preferably comprises at least a first cover part and a second cover part, the first cover part comprising means for fixing to the box body, the second cover part being connected to the first cover part by one or more interconnecting members, the one or more interconnecting members being configured to break by displacing the second cover part relative to the box body while maintaining the connection between the first cover part and the box body.

[0029] A further or additional aspect relates to a packaged needle assembly.The needle assembly is enclosed by a packaging product or a cover and a box as disclosed herein.

[0030] Yet further or additional aspects relate to a method of packaging a product, preferably a needle assembly. The method comprises enclosing a storage volume around the product to be packaged by coupling a box body and a cover as disclosed herein. The method may comprise a further step of exposing the product to a gaseous sterilant. Suitable gaseous sterilants include, but are not limited to, ethylene oxide, nitrogen dioxide, steam, ozone and / or peroxides (e.g., vaporized hydrogen peroxide). Advantageously, the step of exposing the product to the gaseous sterilant may be performed after coupling the cover and the box body (after packaging), for example, just after packaging and / or even after prolonged storage, for example, just before the package is intended to be opened. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] These and other features, aspects, and advantages of the apparatus, systems, and methods of the present disclosure will be better understood through the following description, appended claims, and accompanying drawings, in which:

[0032] Figure 1 A perspective view of a hard shell packaged product in a closed state is provided;

[0033] Figure 2A and Figure 2B A perspective view of the cover and the box body in an open state is provided;

[0034] Figure 3 A detailed cross-sectional side view of the lid and box body in a closed position is provided;

[0035] Figure 4A and Figure 4B Perspective and plan views of the cartridge and needle assembly are provided;

[0036] Figure 5A and Figure 5B A cross-sectional perspective detail of the box is provided;

[0037] Figure 6 A perspective view of packaging a needle assembly is provided;

[0038] Fig. 7A and Figure 7B A partial cross-sectional perspective view of a hard shell packaged product before and after opening is provided;

[0039] Figure 8 A cross-sectional detail side view of a packaged needle assembly is provided;

[0040] Fig. 9A and Fig. 9B The packaged needle assembly is shown being opened;

[0041] Fig.10 A to Fig.10 D shows aspects related to the cover portion of a hard shell packaged product;

[0042] Fig.11 Aspects related to the box cover portion of a hard shell packaging product are shown; and

[0043] Fig.12 The packaging method is schematically shown. DETAILED DESCRIPTION

[0044] The terms used to describe specific embodiments are not intended to limit the present invention. Unless the context clearly indicates otherwise, as used herein, the singular forms "one", "an" and "the" are intended to also include plural forms. The term "and / or" includes any one of the listed related items and all combinations of one or more of the listed related items. It should be understood that the terms "include" and / or "comprise" indicate the presence of the stated features, but do not exclude the presence or increase of one or more other features. It should also be understood that when a specific step of a method is described as being after another step, unless otherwise stated, the specific step may directly follow the other step, or one or more intermediate steps may be performed before performing the specific step. Similarly, it should be understood that when describing a connection between a structure or component, unless otherwise stated, the connection may be established directly or through an intermediate structure or intermediate component.

[0045] As used herein, the term "needle assembly" may be understood to relate to a needle assembly comprising: a hub having a proximal end for connecting to a syringe extending in a proximal region of the hub; and a needle extending longitudinally from the distal end of the hub in a distal region of the hub.

[0046] The needle assembly generally includes at least one sleeve (also referred to as a needle) extending from the needle hub to receive the corresponding matching portion of the syringe. Preferably, the needle assembly is a safety needle assembly, which includes a protective member and a sheath, the protective member is generally implemented as a longitudinally extending barrel that can be engaged on the needle, and the end of the protective member can be removably connected to the hub, and the sheath is pivotally connected to the hub. The sheath generally has two side walls connected by a rear wall, and the two side walls define a receiving space for receiving the needle between the two side walls. The sheath can pivot between a starting position, a use position, and a locked position, in which the sheath is released from the needle, in the use position, the sheath pivots away from the needle and exposes the needle, and in the locked position, the sheath is locked to fix the needle in the receiving space. In the locked position, the sheath protects the needle from accidental contact, contamination, needle stick injury, etc. after the needle is used. In the locked position, the needle is received in the receiving space of the sheath to be enclosed by the sheath and so cover the needle.

[0047] The packaged product is particularly, although not exclusively, beneficial for safety needle assemblies such as those described in full detail in PCT / EP2021 / 063205, which is incorporated herein by reference.

[0048] The safety needle assembly preferably comprises: a hub having a proximal end for connecting to a syringe extending in the proximal region of the hub; a needle extending longitudinally from the distal end of the hub in the distal region of the hub; a sheath pivotally connected to the hub, the sheath having two side walls connected by a rear wall, the two side walls defining a receiving space for receiving the needle between the two side walls; wherein the sheath is adjustable between a starting position, a use position, and a locking position, in which the sheath is positioned approximately in the distal region of the hub, in which the sheath is positioned approximately in the proximal region of the hub, in which the sheath (protective member) is locked to fix the needle in the receiving space; wherein in the starting position, the sheath extends longitudinally from the hub, wherein the hub is provided with at least one first mating element and the sheath is provided with at least one second mating element, wherein in the locking position of the sheath, the first mating element and the second mating element engage with each other to lock the sheath, characterized in that in the starting position, the first mating element and the second mating element contact each other to define the starting position of the sheath.

[0049] By providing a sheath extending longitudinally from the hub in the starting position, the occupied space of the safety needle assembly in the starting position (therefore for packaging purposes) becomes much smaller, so that different types of packaging and / or more effective packaging and / or transportation and / or storage can be carried out. For example, by this reduced occupied space, hard box packaging can be considered so that the packaged safety needle assembly can be automatically processed. However, the automated processing of the assembly of the blister package is actually impossible, which causes the need to manually collect the assembly of the blister package in the box for transportation and storage. This limits the speed of the assembly line. By providing a sheath in the position extending longitudinally from the hub in the starting position, a more compact arrangement of the safety needle assembly can be obtained, so that hard box packaging can be carried out. This hard box packaging can be automatically processed, so that the speed of the assembly line can be increased, so as to realize more efficient production, packaging, transportation and / or storage of the safety needle assembly. In addition, by using a hard cover, the working method of preparing the needle assembly for use remains unchanged. This is beneficial for the user because he can follow the program he is used to. When the cover of the hard case is removed, the hub of the needle assembly is exposed and can be connected to the syringe without compromising sterility and avoiding possible contamination. When connected to the syringe, the hard case can be removed from the needle assembly and the sheath can be pivoted to the use position to prepare the needle with the syringe for use.

[0050] The rigid case preferably comprises or consists essentially of a medical grade composition, preferably an injection moldable plastic composition, such as polypropylene.

[0051] The present invention is described more fully below with reference to the accompanying drawings, in which embodiments of the invention are shown. In the accompanying drawings, the absolute and relative sizes of systems, components, layers, and regions may be exaggerated for clarity. The embodiments will be described with reference to schematic and / or cross-sectional views of possible idealized embodiments and intermediate structures of the present invention. In the specification and drawings, similar reference numerals always represent similar elements. Relative terms and their derivatives should be understood to represent orientations as described subsequently or shown in the drawings discussed. Unless otherwise stated, these relative terms are for convenience of description and do not require that the system be constructed or operated in a specific orientation.

[0052] Figure 1 , Figure 2A and Figure 2B Provides a closed state ( Figure 1 ) and the open state ( FIG. 2A to FIG. 2B ) is a perspective view of a hard shell packaged product 1. As shown, the hard shell packaged product 1 includes at least two parts: a box body part 2 and a cover part 3. The box body part and / or the cover part may include a flat portion (such as shown). The flat portion prevents the product from rolling, such as rolling along a tabletop. The cover 3 and the box body 2 can be slidably engaged, such as FIG. 2A to FIG. 2B As shown, the closed state is achieved. Note that the side wall sections 20 and 30 overlap circumferentially. To this end, the inner dimension of the cover is configured to be slightly larger than the outer dimension of the box body, and vice versa. The closed hard shell packaging product defines an inner volume for storing the needle assembly. As will be referred to Figure 2A and Figure 2B In further detail, the hard shell packaged product 1 comprises a channel 5 extending in the longitudinal direction between the overlapping side wall sections and providing a gas passage to the enclosed volume. To this end, a spacer 7 is provided between the overlapping side wall sections.

[0053] In addition, the spacers, shown as longitudinally extending ribs, also advantageously provide contact and / or friction between the cover and the box body to provide a tight or secure fit. To facilitate removal of the cover and / or box body, one or more external members for manual gripping may be provided, such as Figure 1 and Figure 3 The ribs 9 shown in FIG.

[0054] Should be understood that the spacer can be arranged on one or more of the inner / outer surface of the cover or the box body. Similarly, should be understood that the term "spacer" also includes other geometric shapes (including but not limited to nutshell-shaped portion (dome)) except the rib shown.

[0055] As in Figure 2A and Figure 3As can be seen in more detail in , the spacer can advantageously define the cross-sectional dimensions of the channel. The channel length L can be understood to be mainly defined by the overlapping distance between the cover and the box body. The length L1 of the overlap is usually ≥2mm. The longer the overlap, the more complicated the entry path for pollutants to enter. In principle, the overlap can be larger. The longer the overlap, the more stably the cover can be positioned on the box body. For example, the overlap L1 can be up to about 20mm, for example in the range of 2mm to 20mm or in the range of 3mm to 10mm. Preventing re-contamination is considered to be related to providing a channel for stagnant air. It is found that an overlap of 2mm can prevent re-contamination. In fact, the overlap length L1 is between 5mm and 10mm, for example, about 8mm. The range between 5mm and 10mm is confirmed to be the optimal range between the compactness and stability of the cover installed to the box body. The width of the channel (the distance between the opposite sides) is preferably as thin as possible while enabling gas to pass. Typically, the distance "d" between the opposite sides is less than 1mm. In principle, the spacing can be larger, for example up to 2 mm or even 3 mm or more. The thinner the channel, the more compact the packaged product can be. Preferably, the spacing "d" ≤ 0.5. More preferably, d ≤ 0.3 mm, for example about 0.2 mm. The wider the channel, the greater the chance of potential recontamination and the less compact the packaged product. A spacing of about 0.05 mm has been found to be sufficient.

[0056] In a preferred embodiment, for example, a protrusion is shown, which is used for a dedicated contact between the opposing sidewall surfaces of the box body and the cover. This limits the flush contact area between the cover and the box body to a point or line contact that is substantially defined by the protrusion.

[0057] In some embodiments, for example Figure 1 and Figure 4A As shown, one or more additional spacers 7a are arranged between the face 3f of the cover and the opposite face of the box body (e.g. the face 2f of the collar 25) to ensure an axial gap between the cover and the box body in the closed state, e.g. Figure 1 and Figure 3 shown.

[0058] Figure 4A A perspective view of needle assembly 100 inserted into cartridge 2 along its longitudinal axis is provided. Figure 4B A corresponding plan view is provided. Preferably, after removal of the cover, the end portion of the hub 102 protrudes from the box body.

[0059] To prevent the needle assembly 100 from rotating within the interior of the cartridge, one or more inwardly extending ribs 71 or grooves 72 may be provided (e.g., Figure 4B , Figure 5A and Figure 3), one or more inwardly extending ribs or grooves engage with the needle assembly 100 (eg, as shown, with the needle guard 103 and / or the hub 102).

[0060] Alternatively or additionally, internal rotation of needle assembly 100 may be mitigated by the internal cross-sectional geometry of the cartridge.

[0061] Preferably, the box of the hard shell packaging product includes one or more retaining members. The retaining member is configured to hold the needle assembly 100 in place in the box even when the cover is removed. The needle assembly 100 can be removed by applying a predetermined minimum extraction force (e.g., by pulling the hub). Figure 5A and Figure 5B The cassette 2 is depicted including a retaining member 10 implemented as an inwardly extending protrusion that engages with a corresponding groove provided along the barrel 104 of the needle assembly to prevent accidental release or dropping of the needle assembly 100 or even the cassette. Figure 6 An embodiment is depicted in which the retaining member 10 is configured as a plurality of ribs that engage with the edge of the needle guard 103 and / or hub 102 to prevent accidental release or dropping of the needle assembly 100 or even the cartridge.

[0062] The hard shell packaging product can advantageously be shaped to closely follow the outer geometry of the needle assembly 100. This provides a compact packaging solution. In some embodiments, the overall shape of the hard shell packaging product can resemble a cylindrical shape. Other shapes are also possible. For example, a hard shell packaging product 1 having a rectangular cross-section, such as Figures 6 to 11 shown.

[0063] Figure 6 Perspective views of a needle assembly and a hard case packaged product are provided, the hard case packaged product including a box body and a cover and having improved tamper-evident features while maintaining post-assembly sterilization aspects.

[0064] like Figure 6 As shown, the cover portion includes a first portion 31 and a second portion 32. Fig. 7A , Figure 7B and Fig.10 To elaborate further, these parts are connected to each other (at least initially) by one or more disposable interconnecting members 33. The cover may be understood as a segmented cover comprising a top cover portion and a circumferential skirt.

[0065] When the cover is assembled to the box body, the skirt and a portion 30 of the second cover portion overlap the side wall of the box body. Figure 8 As shown in more detail in FIG. 1 , the channel 5 is formed between overlapping side wall sections of the box body and the cover. Figure 3Similar to what has been described, a gas passage P is formed in the space between the opposing faces 21f and 31f of the box and cover. The spacing (gap "g") between the first cover portion and the second cover portion provides access to the gas passage.

[0066] The overlap L2 between the box body and the second cover part is preferably as small as possible while maintaining a length sufficient to provide a stagnant air path. The shorter the overlap, the lower the likelihood of repositioning the second cover part after initial opening. As previously mentioned, the minimum overlap can be as low as 2 mm. Typically, the overlap L2 between the box body and the second cover part is in the range of 3 mm to 5 mm, for example, about 3.5 mm. The spacing distance between the opposing side walls ("d", see Figure 3 ) is preferably less than 1 mm, more preferably ≤0.5 mm, most preferably ≤0.3 mm, for example about 0.2 mm.

[0067] In order to provide a tight fit between the cover and the box body and / or to define the cross-sectional dimensions of the gas passage, ribs or protrusions may be provided for the cover and / or the box body (not shown for clarity). In order to further reduce the possibility of repositioning the second cover part after initial opening, the ribs are preferably provided exclusively on the section of the first cover part and / or the box body side wall that engages with the second cover part. Most preferably, the spacing between the opposing faces 21f, 31f of the cover and the box body side wall is defined by a partition 2s (e.g., a circular protrusion) that is arranged between the box body and the first cover part 31 (e.g., as Figure 8 Between the inner surfaces of the circular rim 31) shown in FIG.

[0068] The cover and the box body are secured to each other by one or more interlocking interconnection means 6. Return Figure 6 , Fig. 7A and Figure 7B It will be appreciated that the initial engagement of the interconnecting member 6a (depicted as a groove) disposed on the first cover portion 31 with the interconnecting member 6a (depicted as a clamp) disposed on the second cover portion 31 forms an interlocking connection coupling the cover to the box body.

[0069] Fig. 7A A partial cross-sectional perspective view of a closed hard shell packaged product is provided. A gas passage P extending between the lid and the box body enables gas to enter the interior of the packaged product in the closed state.

[0070] The interconnection member is configured to be broken by displacing the second cover portion 32 relative to the case body 2 while maintaining the coupling between the first cover portion 31 and the case body 2 .

[0071] Figure 7BA partial cross-sectional perspective view of a hard shell packaged product is provided which has been opened after initial closure by displacing the second cover portion relative to the box body (eg by pulling). Rather than disconnecting or opening the interlocking connection, the pulling force causes an irreversible breakage of the interconnecting member 33'.

[0072] Breaking the interconnection member 33' while maintaining the connection between the box body and the first cover part 31 not only provides a visual indication of the opening of the enclosure, but also prevents the box body from being reclosed, for example by a new cover. Preferably, the single-use interconnection device 6, 6a, 6b is further protected from tampering. In one embodiment, for example, Fig. 7A As shown in , by providing a pushing member 8 that at least partially overlaps the means for securing the first cover portion to the box body, manual access to the interconnection means 6, 6a, 6b can be limited. Advantageously, the pushing member 8 can also provide a contact point for an operator or machine grip to provide force to assemble the cover to the box body. Therefore, one or more gripping or pushing members also protect the relatively fragile interconnection member 33 between the first part 31 and the second part 32 from damage during the assembly of the cover to the box body. Advantageously, the pushing member 8 prevents or at least hinders the release of the first cover portion 31 from the box body 2 because the pushing member limits access to the members 6a and 6b (see, for example Fig. 7A ) between the interlocking movements.

[0073] Alternatively or additionally, a label 6 (eg a self-adhesive label) may be provided extending from the box body across the boundary between the cover parts.

[0074] Fig. 9A and Fig. 9B Further shown is the process of opening by breaking one or more interconnecting members 33. Fig. 9A and Fig. 9B As shown, the packaged product can be opened by an end user who displaces the second cover portion relative to the box body. Fig. 9B As shown, opening may involve, for example, displacing the second cover portion relative to the box body along the longitudinal axis of the box body by applying a pulling force to the cover. Figure 1 4 ), the removal of the cap may involve a rotational movement about the longitudinal axis, for example similar to the unscrewing movement of a bottle cap. Alternatively or additionally, opening the packaged product may involve rotating along the boundary between the first cap portion and the second cap portion, for example as Fig. 9A shown.

[0075] Fig.10Aspects related to the cover portion of a hard shell packaging product are shown. It should be understood that the interconnecting members 33-1, 33-2, 33-3, 33-4 can be implemented in various ways. In some embodiments, such as shown in B, the interconnecting member can be considered as a substantially straight member that bridges the gap "g" between the first cover portion 31 and the second cover portion 32.

[0076] Alternatively, the interconnecting member 33 can be configured to include a tapered shape with a neck, such as shown in "A" and "D". The neck can advantageously define the fracture strength and fracture position so that the visual marking of the connection after fracture (i.e., the remaining part) can be primarily directed to a specific cover portion, such as a cover portion that has not been removed from the box body. Alternatively or additionally, the interconnecting member 33 can include an inclined portion, such as shown in "C". Each embodiment is manufactured by injection molding. Mark 36 indicates the remnant of the entry point of the mold. Considering the flow direction, embodiment D may be preferred.

[0077] In some embodiments, the cassette sidewalls include features such as ledges, slots or magnets etc. The ledges / features may advantageously provide a grip for machine handling (eg so-called autofeeders). Figure 2B A cassette is shown comprising an outwardly extending collar 25. The collar provides a surface that enables automated handling of the cassette. In addition, preferably, the cassette is substantially free of protrusions and extends beyond the crosspiece to enable rotationally independent machine gripping.

[0078] Preferably, the cover and the box body are further configured / sized to prevent nesting of the box body and / or nesting of the cover. Nesting hinders the automated packaging process. In order to prevent nesting (also known as train-formation), the box body and / or the cover may further include one or more components (e.g., lips) that limit the formation of a flush contact area between the cover and / or the box body. Fig.12 An embodiment is depicted in which the case includes an inwardly extending lip 12 that eases tandem assembly by preventing the bottom face of an adjacent case from extending into the case.

[0079] The box and cover as disclosed herein may be particularly beneficial for packaging a product in a sterile package ready for immediate use by an end user. The packaged product advantageously enables sterilization of the product in the packaged state while providing effective tamper protection by one or more of the following components: a component that provides a visual indication of an opening event and / or a component that physically hinders tampering.

[0080] Fig.12A method of packaging a product, preferably a needle assembly, is shown. The method 200 comprises a step of closing 201 a storage volume around the product to be packaged by coupling a box body 2 and a cover 3 as disclosed herein. Advantageously, the method may comprise a step 202 of placing the packaged product in a gaseous sterilant after coupling the cover to the box body.

[0081] For purposes of clarity and concise description, features are described herein as being part of the same embodiment or different embodiments; however, it should be understood that the scope of the present invention may include embodiments having all or a combination of some of the described features.

[0082] For example, in some embodiments, a packaged needle assembly product is provided, the packaged needle assembly product comprising: a hard shell packaging product, the hard shell packaging product comprising a box body and a cover, the box body and the cover are arranged in an assembled configuration to form a shell for the needle assembly; and an adhesive label, the adhesive label is adhered to the outer surface of the shell, wherein the label extends across at least a portion of the circumferential gap between the edge of the cover and the edge of the box body, thereby sealing the hard shell packaging product, wherein the label includes a perforated section, the perforated section includes a plurality of perforation lines, the plurality of perforation lines cross the gap at an angle (θ) from a first end to a second end, the first end terminates at or exceeds the edge of the cover, and the second end crosses the gap and terminates at or exceeds the edge of the box body.

[0083] Wherein, the box body and the cover are configured to be slidably engaged into an assembled configuration, and wherein the box body and the cover include circumferentially overlapping side wall segments, and wherein the hard shell packaged product includes one or more radial channels, which extend in a longitudinal direction between the overlapping side wall segments to provide a gas passage to the interior of the enclosure.

[0084] In some embodiments, the channel is at least partially defined by one or more protrusions extending outward from at least one of: an inner surface of a circumferential overlapping wall segment of the cover portion, which inner surface faces a corresponding overlapping wall segment of the box body; and an outer surface of a circumferential overlapping wall segment of the box body, which outer surface faces a corresponding wall segment of the cover portion.

[0085] In interpreting the attached claims, it should be understood that the word "comprising" does not exclude the presence of other elements or actions in addition to the elements or actions listed in a given claim; the word "one" or "an" before an element does not exclude the presence of multiple such elements; any figure mark in the claim does not limit the scope of the claim; multiple "devices" can be represented as one or more items or implemented structures or functions that are the same or different; unless otherwise specifically stated, any of the disclosed devices or parts of the claims can be combined together or separated into other parts. Where one claim refers to another claim, this may indicate the synergistic advantages achieved by the combination of the respective features of these claims. However, the fact that some measures are listed in different claims does not mean that the combination of these measures is not advantageous. Therefore, embodiments of the present application may include all valid combinations of claims, wherein each claim may, in principle, refer to any preceding claim unless explicitly excluded by the context.

Claims

1. A hard shell packaging product (1) for a needle assembly (100), the needle assembly comprising a sleeve (101) extending from a hub (102), the sleeve being used to receive a corresponding matching portion of a syringe, the hard shell product comprising: a box body (2) and a cover (3), the box body and the cover being configured to be slidably engaged in an assembled configuration so as to define a closed volume (4) for the needle assembly (100), The box body and the cover comprise circumferentially overlapping side wall sections (20, 30), and one or more radial channels (5) are provided, extending in the longitudinal direction between the overlapping side wall sections and providing a gas passage (P) leading to the enclosed volume.

2. A hard shell product according to claim 1, comprising one or more disposable means (6, 6a, 6b) for securing the cover to the box body.

3. The hard shell product according to claim 1 or 2, wherein: The cover portion (3) at least comprises: a first cover part (31) comprising one of the one or more means (6a, 6b) for fixing to the box body; and A second cover part (32), the second cover part is connected to the first cover part by one or more interconnecting members (33), and the one or more interconnecting members are configured to break by displacing the second cover part (32) relative to the box body (2) while maintaining the connection between the first cover part (31) and the box body (2).

4. The hard shell packaging product according to any one of claims 1 to 3, wherein: The channel (5) is at least partially defined by one or more protrusions (7) extending outwardly from at least one of: an inner surface of a circumferentially overlapping wall section of the cover (31), the inner surface facing the corresponding overlapping wall section of the box body (21), and The outer surface of the circumferentially overlapping wall section of the box body (21) faces the corresponding wall section of the cover (32).

5. The hard shell packaging product according to claim 3 or 4, wherein: One or more of the interconnecting members (33) for securing the first cover portion (31) to the case (2) comprises interlocking elements (34, 35) configured to snap into a locked position.

6. The hard shell packaging product according to claim 5, wherein: Each of the means for securing the first cover portion to the cassette and the interconnecting members are configured to break at a force less than a breakaway force for releasing the interlocking element from the locked position.

7. A hard shell packaged product according to any one of the preceding claims, wherein: The case is configured to limit the rotational freedom of the needle assembly along the longitudinal direction by providing one or more engagement surfaces disposed along or by an inner surface of the case.

8. The hard shell packaging product according to any one of claims 3 to 7, wherein: The first cover portion comprises one or more outwardly extending pushing members (8).

9. The hard shell packaging product according to claim 8, wherein: The one or more urging members at least partially overlap with the means (6) for securing the first cover portion to the cassette.

10. A hard shell packaged product according to any one of the preceding claims, wherein: One or more of the box body (2) and the second cover part (32) includes a member (9) for external manual grasping to shift the second cover part relative to the box body. Preferably, both the box body and the second cover part include a member for external manual grasping to shift the second cover part relative to the box body.

11. A hard shell packaged product according to any one of the preceding claims, wherein: The inner side wall of the box body (2) includes one or more retaining members (10), such as a circumferential edge, which engage with the needle assembly to limit the displacement of the needle assembly (100) along the longitudinal direction.

12. A hard shell packaged product according to any one of the preceding claims, wherein: The box body has an outer section which is generally circular and free of protrusions and which is bounded by an outwardly extending crosspiece (11).

13. A hard shell packaged product according to any one of the preceding claims, wherein: The box body also includes one or more lips (12) which limit the formation of a flush contact area between the outer and inner surfaces (2-1, 2-2) of the stacked boxes.

14. The hard shell packaging product according to any one of claims 2 to 13, wherein: The disposable means for securing the cover to the housing comprises a label (13) extending circumferentially across the boundary between the cover and the housing.

15. The hard shell packaging product according to claim 14, wherein: The label includes a plurality of perforation lines extending across a boundary between the cover and the box body.

16. A cover (3) and a box (2) for assembling a hard-shell packaged product (1), such as a hard-shell product according to any one of the preceding claims for packaging a needle assembly, the cover and the box defining in a coupled configuration a capsule for a product to be stored, wherein: The box body and the cover are configured to provide circumferentially overlapping side wall sections in the coupled configuration, and wherein one or more radial channels (5) extending in the longitudinal direction between the overlapping side wall sections are provided to provide a gas passage to the needle assembly.

17. The cover and box body according to claim 16, wherein: The cover portion at least comprises: a first cover part (31), said first cover part comprising means for fixing to said box body; and A second cover part (32) is connected to the first cover part (31) by one or more interconnecting members (33), and the one or more interconnecting members are configured to break by displacing the second cover part (32) relative to the box body while maintaining the connection between the first cover part (31) and the box body (2).

18. A packaged needle assembly (100) enclosed by the packaging product (1) or the cover (3) and the box (2) according to any one of the preceding claims.

19. The packaged needle assembly of claim 18, wherein: The needle assembly also includes a needle guard (103).

20. A method (200) of packaging a product, preferably a needle assembly (100), the method comprising: A storage volume around a product to be packaged is closed (201) by coupling a box (2) and a cover (3) according to any one of claims 1 to 19.

21. The method according to claim 20, wherein: The method includes exposing (202) the product to a gaseous sterilant after coupling the cover and the case.

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