Packaged Needle Assembly

Abstract

FIELD OF THE DISCLOSURE The present disclosure relates to medical devices, and more particularly to hard shell packaging products, packaging products and packaging methods for sterile packaging of needle assemblies. The hard shell product includes a case (2) and a cap (3) configured to be in engagement with each other to define an enclosure (4) for the needle assembly (100), with one or more radial channels formed therein extending longitudinally between the overlapping side wall sections and forming a gas passageway to the enclosed volume. In a preferred embodiment, the cap comprises a first cap part (31) and a second cap part (32) configured to be broken by displacing the second cap part (32) relative to the case (2) while maintaining a coupling connection between the first cap part (31) and the case (2) via one or more interconnecting members (33).

Description

[Technical field]

[0001] The present invention relates generally to medical devices, and more specifically to hard case packaging products, packaging products, and packaging methods for sterile packaging needle assemblies for use in medical injection devices.

[0002] Safety needle assemblies are widely known and used. Essentially, a safety needle assembly comprises a hub having a proximal end for connection to a syringe. Prior to use, the assembly is stored in a package in a sterile condition.

[0003] Blister packaging solutions are widely known. In use, a user, e.g. a paramedical worker, partially opens the blister to release the hub, and then connects the hub to a syringe, keeping the assembly in the package to avoid contamination or possible destruction of the sterility of the needle assembly. The user then further removes the package to release the safety needle assembly. This process is rather complicated and prone to user error.

[0004] While allowing for storage of sterilized products, blister packages generally have low compatibility with high-speed automated packaging processes. For example, blister packages have flexible or deformable parts that are difficult to grasp by automated pick-up or assembly tools. Also, blister packages can be easily deformed or damaged by automated handling, so that packaging processes are generally slow and / or require one or more manual handling steps. Moreover, blister packages tend to be relatively bulky, which is a drawback in terms of storage and transportation.

[0005] No. 5,993,366 discloses a solution container having first and second members which, when attached, form a closed container having first and second interior spaces. No. 5,993,366 discloses a vented cap and capillary tube assembly including a capillary tube having an aperture therethrough and a cap slidably mounted on one end of the tube and having a vent groove to allow air to escape when in a particular position. No. 5,993,366 discloses a needle container in which the cap fits into an open aperture in a hub to maintain sterility and the tip of the closure portion extends sufficiently into the aperture of the container to maintain sterility. No. 5,993,366 discloses an injection molding assembly that may seal a threaded or non-threaded container using a double cap with a pressure sensitive recessed seal. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] International Publication No. 2016108869 [Patent Document 2] European Patent Application No. 0517121 [Patent Document 3] U.S. Pat. No. 3,149,717 [Patent Document 4] U.S. Patent Application No. 2002 / 130100 Summary of the Invention [Problem to be solved by the invention]

[0007] Hard case packaged products may partially overcome the drawbacks of mechanical handling, however, the relatively more rigid enclosure disadvantageously impedes sterilization of the packaged product by limiting access to radioactive and / or fluid sterilizing materials.

[0008] There is also a need to provide a tamper evident packaging solution, especially in hard case packaged products, to reassure the end user of the quality of the product and the sterility of the product by indicating that the package has not yet been opened.

[0009] Therefore, there is a need for a packaging solution that overcomes or at least mitigates one or more of the above-mentioned shortcomings. [Means for solving the problem]

[0010] Aspects of the present disclosure relate to hard-shell packaging products, and in particular to hard products for packaging needle assemblies.

[0011] As described in more detail below, and as described herein, the packaged product is advantageously a packaged product that is relatively compact, offers improved automated machine handling characteristics, offers improved ease of user operation, such as when connecting a syringe to a hub, and / or has tamper-evident features while allowing the packaged product to be sterilized by a gaseous sterilant.

[0012] A hard shell packaging product comprises at least a case and a cap, which are configured to engage with each other, preferably by sliding one over the other a pre-designed distance, and the case and cap have circumferentially overlapping sidewall sections. The hard shell packaged product further comprises one or more radial channels extending longitudinally between the overlapping side wall sections in the engaged condition, thereby forming one or more channels that permit or facilitate the passage of gas to a packaged product contained within an enclosed volume such as that defined by the cap and case. Providing a gas passageway to the enclosed volume advantageously allows for sterilization of the packaged product, e.g., the needle assembly. As described in more detail below, the packaged product advantageously allows gas access to the needle assembly for sterilization with a gaseous substance when enclosed by the cap and case. Preferably, the channel forms the only path between the interior volume and the environment. The channel extends a predetermined distance, e.g., a pre-designed distance, between the inner surface of the cap and the outer surface of the case (or vice versa), thereby mitigating recontamination of the needle assembly with air-containing infectious agents.

[0013] Preferably, the hard-shell packaging product comprises one or more single-use means for securing the cap to the case. The single-use securing means breaks or deforms irreversibly upon opening of the package. Such single-use securing means provides a visual indication that sterility has been broken, for example, by accidental or unauthorized pre-opening of the packaging product. As described in further detail below, the single-use securing means may be embodied by one or more pairs of interengaging (e.g., snap-lock) members along the cap and case. Alternatively or additionally, the single-use securing means may be embodied by one or more interconnecting members (e.g., bridge members that interconnect the separate members of the hard-shell packaging product and that irreversibly deform, e.g., break, when a threshold force and / or stress is exceeded). It will be appreciated that the single-use securing means may advantageously further prevent reclosing or reassembly of the cap and case after initial assembly.

[0014] The hard shell product is preferably embodied such that the cap comprises at least two parts, including one cap part having one or more means for fastening to the case and a second cap part connected to the first cap part by one or more interconnecting members. The interconnecting members are configured to be irreversibly broken by displacing the second cap part relative to the case while maintaining the interlocking connection between the first cap part and the case. Thus, the package can be opened by removing the second cap part without releasing the first cap part from the case. The remaining interconnecting means (broken or deformed) can advantageously provide a visual indication of the removal of the second cap part, thereby improving tamper resistance by preventing reclosing of the packaged product once opened. The interconnecting members can also advantageously define the force, e.g. torque and / or linear tensile force, required to open the package.

[0015] The first cap component, the second cap component and the interconnecting member are preferably integrally formed as a single piece, for example by injection molding, to mitigate potential tampering, ease manufacturing conditions, and / or reduce the total area of ​​contact interfaces that may be obstructed for access by a gaseous sterilant.

[0016] In a preferred form, the overlapping sidewalls are separated across the gap by one or more spacers. The spacers may advantageously define a cross-section of the gap. The spacers further advantageously create a contact and / or friction force between the cap and case, thereby creating a snug or tight fit.

[0017] The spacer may be provided by one or more protrusions, such as ribs, pips, hemispheres, or other shaped protrusions extending from one of the inner surfaces of the overlapping sidewall sections of the cap that face the corresponding overlapping sidewall sections of the case, and the outer surfaces of the circumferential overlapping sidewall sections of the case that face the corresponding overlapping sidewall sections of the cap.

[0018] Advantageously, the overlapping wall sections may contact one another exclusively via one or more protrusions, thereby reducing the total area of ​​surfaces (surfaces in flush contact) that are blocked from contact by the gaseous sterilant.

[0019] To prevent or at least impede removal of the first cap member from the case after initial assembly, one or more interconnecting members for securing the first cap part to the case may comprise interlocking elements, for example members configured to snap into a locked position, such as hook and slot or one or more protrusions and corresponding socket members. Preventing or at least impeding removal of the first cap member from the case after initial assembly further improves tamper-evident functionality.

[0020] It will be appreciated that the interconnecting members are preferably configured to break at a force less than the snap disengagement force required to release the locking elements from the locked position.

[0021] Preferably, the case is further configured to limit the rotational freedom of the needle assembly while within the case. Rotation of the needle assembly along its longitudinal axis (direction along the central axis of the case) within the case may prevent attachment / coupling of the needle assembly to the hub of the syringe. Limiting rotation of the needle assembly within the case may avoid user error, particularly when the hub is configured to couple to the syringe by rotation or a screwing action (e.g., a luer lock). The limited rotational movement may be provided by the case comprising one or more engagement surfaces configured to engage one or more surfaces of the needle assembly, such as the hub, sleeve and / or needle guard. Thus, the case may advantageously be provided with one or more engagement surfaces (such as slots, pips or ribs) that are sized and positioned to engage an outer surface of the needle assembly upon rotation. Alternatively or additionally, the interior volume may be shaped to prevent rotation of the needle assembly, for example by a cross-sectional shape (e.g., rectangular, etc.).

[0022] To prevent unintentional damage, for example during (mechanical) assembly of the cap to the case, the interconnecting member (e.g. bridge) interconnecting the first and second cap parts is preferably provided with one or more push or gripping members. The gripping or pushing members form contact points for an operator or machine grip to apply a force to assemble the cap to the case. Typically, the gripping or pushing members extend outwardly from the outer surface of the first cap part. Alternatively or additionally, the gripping portions may be formed by one or more slots or trenches. Thus, the gripping or pushing members protect the relatively fragile interconnecting member between the first and second parts from damage during assembly of the cap to the case.

[0023] Preferably, the one or more push members at least partially overlap the means for securing the first cap part to the case. At least partially overlapping the means for securing the first cap part to the case limits access to the interconnection once formed between the case and the cap, thereby further increasing tamper protection.

[0024] At least one (and preferably both) of the case and second cap part may be provided with one or more external gripping members to increase external manual gripping, for example for disconnecting the cap from the case.

[0025] Alternatively or additionally, the hard-shell packaging product preferably includes one or more limiting members for limiting the displacement of the needle assembly along the longitudinal direction within the case. The limiting members confine the needle assembly within the case even with the cap in an open state until the retention force is overcome, for example by a pulling force intentionally applied by a user, thus preventing accidental dropping. The limiting members are primarily provided along the inner wall of the case that engages with the needle assembly, for example along a peripheral rim.

[0026] Alternatively or in addition to one or more single-use means for securing the cap to the case, an adhesive label may be applied. The label preferably extends circumferentially across the boundary between the cap and the case and / or between the cap parts, thereby securing the separate parts. Opening the packaged product causes the label to break. The resulting break mark serves as a visual indication that the hard shell packaged product has been opened. To reduce the user force required to break the seal, the label preferably includes a plurality of perforation lines extending across the boundary between the cap and the case. The provision of perforation lines advantageously further increases the visibility of the break mark.

[0027] Thus, in some configurations, the packaging product comprises a label adhered to the exterior of both the case and the cap, the label having a predetermined dimension along a first direction spanning at least a portion of the circumference of the packaging product at the location of the gap, and the label being dimensioned along a second direction to traverse the gap, thereby securing the case to the cap, the label having a perforated section extending bidirectionally in the first dimension of the label, the perforated section comprising a plurality of perforation lines arranged at an oblique angle to the gap, the perforation lines having a first end terminating beyond the edge of the case at the base of the collar and a second end terminating beyond the cap across the gap. It has been demonstrated that an angle of 20° to 40°, preferably 30°, provides optimal visibility of the break mark while maintaining the overall structural integrity of the label to allow automatic application without premature breakage of the label.

[0028] Further or additional aspects relate to a cap and case (e.g., a kit) for assembly into a hard shell packaging product, such as a hard shell product for packaging a needle assembly disclosed herein, where the cap and case in a coupled configuration define an enclosure for a stored product, where the case and cap in a coupled configuration form circumferentially overlapping side wall sections, and where one or more radial channels extending longitudinally between the overlapping side wall sections are configured to form a gas passageway to the needle assembly.

[0029] Preferably, or for reasons described with respect to the packaging product, the cap preferably comprises a first cap part having means for fastening to the case, and a second cap part connected to the first cap part by one or more interconnecting members configured to maintain an interlocking connection between the first cap part and the case while being broken by displacing the second cap part relative to the case.

[0030] A still further or additional aspect relates to a packaged needle assembly, the needle assembly being enclosed by a packaging product or a cap and case as disclosed herein.

[0031] A still further or additional aspect relates to a method of packaging a product, preferably a needle assembly, comprising the step of closing a containment volume around the packaged product by connecting a case and a cap as disclosed herein. The method may comprise the 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, such as vaporized hydrogen peroxide. Advantageously, the step of exposing the product to a gaseous sterilant may be performed after connecting the cap and case (post-packaging), for example immediately after packaging and / or even after extended storage, such as immediately prior to intended opening of the package.

[0032] These and other features, aspects, and advantages of the presently disclosed devices, systems, and methods will become better understood from the following description, appended claims, and accompanying drawings. [Brief description of the drawings]

[0033] [Figure 1] FIG. 1 is a perspective view of a hard shell packaged product in a closed state. [Figure 2A] FIG. 2 is a perspective view showing the cap in a closed state. [Figure 2B] FIG. 2 is a perspective view showing the case in a closed state. [Diagram 3] FIG. 2 is a detailed cross-sectional side view showing the cap and case in a closed position. [Figure 4A] FIG. 2 is a perspective view showing a case and needle assembly. [Figure 4B] FIG. 4 is a plan view showing the case and needle assembly. [Figure 5A] FIG. 2 is a detailed cross-sectional perspective view showing the case. [Figure 5B] FIG. 2 is a detailed cross-sectional perspective view showing the case. [Figure 6] FIG. 13 is a perspective view showing a state in which the needle assembly is packaged. [Figure 7A] FIG. 2 is a partial cross-sectional perspective view showing the hard shell packaged product before opening. [Figure 7B] FIG. 2 is a partial cross-sectional perspective view showing the hard shell packaged product after it has been opened. [Figure 8] FIG. 2 is a detailed cross-sectional side view of a packaged needle assembly. [Figure 9A] 13A-13D show the opening of a packaged needle assembly. [Figure 9B] 13A-13D show the opening of a packaged needle assembly. [Figure 10] FIG. 1 illustrates aspects relating to a cap component of a hard-shell packaging product. [Figure 11] 1A-1C show aspects relating to case and cap components of a hard-shell packaged product. [Figure 12] FIG. 1 is a schematic diagram showing a packaging method. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] The terms used to describe particular embodiments are not intended to limit the invention. As used herein, the singular forms "a," "an," and "the" are intended to include the plural, unless the context clearly dictates otherwise. The term "and / or" includes any or all combinations of one or more of the associated listed items. It is understood that the terms "comprises" and / or "comprising" specify the presence of the mentioned features, but do not exclude the presence or addition of one or more other features. It is further understood that when a particular step of a method is referred to as succeeding another step, unless otherwise specified, this step may directly follow the other step, or one or more intermediate steps may be performed prior to performing the particular step. Similarly, it is understood that when describing a connection between structures or components, the connection may be made directly or through an intermediate structure or component, unless otherwise specified.

[0035] As used herein, the term "needle assembly" may be understood to refer to a needle assembly comprising a hub having a proximal end for connection with a syringe extending into a proximal region of the hub, and a needle extending longitudinally from a distal end of the hub at a distal region of the hub.

[0036] The needle assembly mainly comprises at least a cannula (also referred to as a needle) extending from a needle hub for receiving a corresponding counterpart of a syringe. Preferably, the needle assembly is a safety needle assembly comprising a guard and a sheath, the guard being mainly embodied as a longitudinally extending sleeve that can be engaged over the needle and can be removably connected at one end of the guard to the hub, the sheath being pivotally connected to the hub. The sheath mainly has two side walls connected by a rear wall and defines a receiving space between the two side walls for receiving the needle. The sheath is pivotable between a start position in which the sheath is released from the needle, a use position in which the sheath is rotated away from the needle to expose the needle, and a locking position in which the sheath is locked to fix the needle in the receiving space. In the locking position, the sheath protects the needle against unintentional contact, contamination, needlestick injury, etc. after its use. In the locked position, the needle is received in a receiving space of the sheath that is surrounded by the sheath, thereby covering the needle.

[0037] Although not exclusively, the packaging product is particularly advantageous in relation to safety needle assemblies, such as the safety needle assembly described in full detail in PCT / EP2021 / 063205, which is incorporated herein by reference.

[0038] The safety needle assembly preferably comprises a hub having a proximal end for connection with a syringe extending into a proximal region of the hub, a needle extending longitudinally from a distal end of the hub at a distal region of the hub, and a sheath pivotally connected to the hub, the sheath having two side walls connected by a rear wall defining a receiving space between the two side walls for receiving the needle, the sheath having a start position in which the sheath is positioned approximately at the distal region of the hub and a stop position in which the sheath is positioned approximately at the proximal region of the hub. It is adjustable between a use position and a locked position in which the sheath (protective body) is locked and the needle is fixed within the receiving space, and in the starting position, the sheath extends longitudinally from the hub, the hub is provided with at least one first corresponding element, and the sheath is provided with at least one second corresponding element, and in the locked position of the sheath, the first and second corresponding elements engage with each other to lock the sheath, and in the starting position, the first and second corresponding elements contact each other to define the starting position of the sheath.

[0039] By providing a sheath extending longitudinally from the hub in the starting position, the area occupied by the safety needle assembly in the starting position, i.e. for packaging purposes, is sufficiently reduced to allow various types of packaging and / or more efficient packaging and / or transport and / or storage. For example, due to such a reduced area occupied, a hard case package may be considered, allowing automated handling of the packaged safety needle assembly. On the other hand, automated handling of a blister-packed assembly is not particularly possible, as a result of which the blister-packed assembly must be manually assembled therein for transport and storage. This limits the speed of the assembly line. By providing a sheath extending longitudinally from the hub in the starting position, a more compact arrangement of the safety needle assembly may be obtained, allowing hard case packaging. Such hard case packaging may be automatically handled, allowing increased assembly line speeds, thus allowing more efficient production, packaging, transport and / or storage of the safety needle assembly. Similarly, by using a hard cap, the operating method for preparing the needle assembly for use remains unchanged. This is advantageous to the user as they may follow a sequence with which they are accustomed. Upon removing the cap of the hard case, the hub of the needle assembly is exposed and may be connected to a syringe without compromising sterility, avoiding possible contamination. Once connected to a syringe, the hard case may be removed from the needle assembly and the sheath may be rotated to a use position, preparing the needle for use with the syringe.

[0040] The hard case preferably comprises or consists essentially of a medical grade composition, preferably a plastic composition that can be injection molded, such as polypropylene.

[0041] The present invention will now be described in more detail with reference to the accompanying drawings, which illustrate embodiments of the present invention. In the drawings, absolute and relative sizes of systems, components, layers and regions may be exaggerated for clarity. The embodiments may be described with reference to schematic and / or cross-sectional views of possible ideal embodiments and intermediate structures of the present invention. In the description and drawings, like reference characters refer to like elements throughout. Relative terms and their derivatives refer to the orientation as described and shown in the drawings under discussion. These relative terms are for convenience of description and do not require the system to be constructed or operated in a particular orientation, unless otherwise stated.

[0042] 1, 2A and 2B provide perspective views of a hard-shell packaging product in a closed state (FIG. 1) and an open state (FIGS. 2A and 2B). As shown, the hard-shell packaging product 1 comprises at least one part, a case part 2 and a cap part 3. The case and / or cap part may comprise a flat portion (e.g., as shown). This flat portion prevents rotational movement of the product, for example along a table top surface. The cap 3 and the case 2 may be slidably engaged to a closed state, for example, as shown in FIGS. 2A and 2B. It is noted that the side wall sections 20, 30 overlap in the circumferential direction. For this reason, the inner dimensions of the cap are configured to be slightly larger than the outer dimensions of the case, or vice versa. The closed hard-shell packaging product defines an interior volume for storing the needle assembly. As will be further detailed with reference to FIGS. 2A and 2B, the hard-shell packaging product 1 comprises a channel 5 extending longitudinally between the overlapping side wall sections and forming a gas passageway to the enclosed volume. For this purpose, spacers 7 are provided between the overlapping side wall sections.

[0043] Also, spacers, shown as longitudinally extending ribs, advantageously further shape the contact force and / or friction between the cap and case, thereby creating a snug or secure fit. To facilitate removal of the cap and / or case, one or more external features for manual gripping, such as rib 9 shown in Figures 1 and 3, may be provided.

[0044] It will be understood that spacers may be provided on one or more of the interior / exterior surfaces of the cap and case, and it will also be understood that the term spacer includes other geometries other than the ribs shown, including but not limited to pips.

[0045] As shown in more detail in Fig. 2A and Fig. 3, the spacer may advantageously define the transverse dimension of the channel. It may be understood that the channel length L is largely defined by the overlap distance between the cap and the case. The overlap length L1 is generally 2 mm or less. The longer the overlap, the more complex the path of entry for contamination to enter. In principle, the overlap may be longer. A longer overlap may more stably position the cap on the case. For example, the overlap L1 may be up to about 20 mm, for example in the range of 2 mm to 20 mm, or in the range of 3 mm to 10 mm. It is believed that preventing recontamination is related to the channel providing stagnant air. In principle, the overlap length L1 is 5 mm to 10 mm, for example 8 mm. The range of 5 mm to 10 mm has been identified as an optimum between compactness and stability of the cap to the case. The width of the channel (distance between the two sides) is preferably as thin as possible while still allowing gas passage. Typically, the distance "d" between the two sides is less than 1 mm. In principle, the separation can be longer, for example up to 2 mm or more, or even 3 mm or more. A thinner channel allows for a more compact packaged product. Preferably, the separation "d" is 0.5 mm or less. More preferably, d≦0.3 mm, for example 0.2 mm. A wider channel allows for more access for possible recontamination and a more compact packaged product. A separation of 0.05 mm has been found to be sufficient.

[0046] In a preferred embodiment, for example as shown, a protrusion is shown for exclusive contact between both sides of the case and cap, which limits the flush contact area between the cap and case to essentially a point or line contact defined by the protrusion.

[0047] In some embodiments, for example as shown in Figures 1 and 4A, one or more further spacers 7a are provided on opposing surfaces between the cap 3f and the case, for example surface 2f of the collar 25, in the closed state, for example as shown in Figures 1 and 3.

[0048] Figure 4A provides a perspective view of needle assembly 100 inserted into case 2 along the longitudinal axis of the assembly. Figure 4B provides a corresponding top view. Preferably, a terminal portion of hub 102 protrudes outwardly from the case after the cap is removed.

[0049] To prevent internal rotation of the needle assembly 100 within the case, one or more inwardly extending ribs 71 or slots 72 (e.g., as shown in Figures 4B, 5A and 3) may be provided which engage the needle assembly 100, for example with the needle protector 103 and / or hub 102 as shown.

[0050] Alternatively or additionally, internal rotation of needle assembly 100 may be mitigated by the internal cross-sectional geometry of the case.

[0051] Preferably, the case of the hard-shell packaged product includes one or more retaining members. The retaining members are configured to hold the needle assembly 100 in place within the case even after the cap is removed. The needle assembly 100 can be removed by applying a predetermined minimum withdrawal force, for example by pulling on the hub. Figures 5A and 4B show the case 2 with a retaining member 10 embodied as an inwardly extending protrusion that engages with a corresponding slot along the sleeve 104 of the needle assembly to prevent the needle assembly 100 from being accidentally released or dropped. Figure 6 shows an embodiment in which the retaining member 10 is implemented as a number of ribs that engage with the edge of the hub 102 and / or the needle guard 103 to prevent the needle assembly 100 from being accidentally released or dropped.

[0052] The hard shell packaging product may advantageously be shaped to closely conform to 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 may resemble a cylinder. Other shapes are possible as well. For example, the hard shell packaging product may have a rectangular cross-section, as shown, for example, in Figures 6-11.

[0053] FIG. 6 provides a perspective view of a needle assembly and a hard shell packaging product including a case and cap that maintains a sterile appearance after assembly while providing improved tamper evident features.

[0054] As shown in Figure 6, the cap comprises a first part 31 and a second part 32. As will be seen in more detail with reference to Figures 7A, 7B and 10, these parts are (at least initially) connected to one another by one or more single-use interconnect members 33. The cap may be understood as a segmented cap having a top cap part and a circumferential skirt.

[0055] When the cap is assembled to the case, the skirt and portion 30 of the second cap part overlap the sidewall of the case. As shown in more detail in Figure 8, a channel 5 is formed between the overlapping sidewall sections of the case and cap. Similar to that described in connection with Figure 3, a gas passageway P is formed in the space between the opposing faces 21f, 31f of the case and cap. The separation, gap "g", between the first and second parts provides access to the gas passageway.

[0056] The overlap L2 between the case and the second cap part is preferably as small as possible while remaining long enough to create a stagnant air path. A short overlap reduces the possibility of repositioning the second cap part after initial opening. As mentioned above, the minimum overlap may be 2 mm. Typically, the overlap L2 between the case and the second cap part is in the range of 3 mm to 5 mm, e.g. about 3.5 mm. The separation distance between the opposing side walls ("d", see FIG. 3) is preferably less than 1 mm, preferably 0.5 mm or less, most preferably 0.3 mm or less, e.g. about 0.2 mm.

[0057] Ribs or protrusions may be provided on the cap and / or case (not explicitly shown) to create a snug fit between the cap and case and / or to define the cross-sectional dimensions of the gas passages. To further reduce the possibility of repositioning the second cap part after initial opening, the ribs are preferably provided exclusively on the section of the case side wall that engages the first cap part and / or the second cap part. More preferably, the space between the opposing faces 21f, 31f of the cap and case side walls is defined by a separator 2s, e.g. a circular protrusion, provided between the case and the inner surface of the first cap part 31, e.g. a circular rim 31 as shown in FIG. 8.

[0058] The cap and case are secured together by one or more interlocking interconnection means 6. Referring again to Figures 6, 7A and 7B, it will be seen that initial engagement of interconnection members 6a (shown as slots) in first cap part 31 forms an interlocking connection linking the cap to the case.

[0059] 7A provides a partial cross-sectional perspective view of a closed hard shell packaged product. A gas passageway P extending between the cap and case allows gas access to the interior of the packaged product in the closed state.

[0060] The interconnecting member is configured to be broken by displacing the second cap part 32 relative to the case 2 while maintaining the interlocking connection between the first cap part 31 and the case 2 .

[0061] 7B provides a partial cross-sectional perspective view of a hard shell packaged product that has been opened after an initial closed state by displacing, e.g., pulling, the second cap component relative to the case. Rather than disconnecting or opening the interlocking connection, the pulling force results in irreversible failure of interconnecting member 33'.

[0062] Breaking the interconnection member 33' while maintaining the connection between the case and the first cap part 31 not only provides a visual indication that the enclosure has been opened, but also prevents reclosing of the case, for example by a new cap. Preferably, the single-use interconnection means 6, 6a, 6b are further protected from breaking. In one embodiment, manual access to the interconnection means 6, 6a, 6b may be restricted by providing a push member 8, which at least partially overlaps the means for fixing the first cap part to the case, as shown for example in FIG. 7A. Advantageously, the push member 8 may also form a contact point for an operator or machine grip, forming the force for assembling the cap to the case. The grip or push member thus protects the relatively fragile interconnection member 33 between the first and second parts 31, 32 from being damaged during assembling the cap to the case. Advantageously, the push member 8 prevents or at least impedes release of the first cap part 31 from the case 2, as the swish part limits access to disturbance of the interlock between the parts 6a, 6b (see FIG. 7).

[0063] Alternatively or additionally, a label 6 (eg, a self-adhesive label) may be provided extending from the case across the interface between the cap parts.

[0064] 9A and 9B further illustrate the opening process by breaking one or more interconnecting members 33. As shown in FIGS. 9A and 9B, the packaged product can be opened by an end user displacing the second cap part relative to the case. As shown in FIG. 9B, opening can involve displacement of the second cap part relative to the case along the longitudinal axis of the case, for example by applying a pulling force to the cap. For embodiments having an essentially circular cross section (e.g., as described with respect to FIGS. 1 to 4), in particular, removal of the cap can involve a rotational movement about the longitudinal axis, similar to the unscrewing movement of a bottle cap, for example. Alternatively or additionally, opening the packaged product can involve rotation along the interface between the first and second cap parts, for example, as shown in FIG. 9A.

[0065] 10 shows an embodiment of the cap parts of a hard shell packaging product. It will be understood that the interconnect members 33-1, 33-2, 33-3, 33-4 can be embodied in a variety of ways. In some embodiments, the interconnect members can be considered as essentially linear members that span the gap "g" between the first cap part 31 and the second cap part 32, for example as shown at B.

[0066] Alternatively, the interconnecting member 33 may be configured to have a tapered shape with a neck, for example as shown in "A" and "D". The neck advantageously defines the failure strength and failure location, so that a visual marker (e.g., remaining portion) of the broken connection may be directed primarily at a particular cap part, for example, the cap part that has not been removed from the case. Alternatively or additionally, the interconnecting member 33 may have a sloped portion, for example as shown in "C". Each of the embodiments was manufactured by injection molding. Mark 36 indicates the vestige of the mold entry point. From a flow direction standpoint, embodiment D may be preferred.

[0067] In some embodiments, the case side walls include features such as ledges, grooves or magnets. The ledges / features advantageously form grips for mechanical handling (e.g. so-called automatic feeders). Figure 2B shows the case with an outwardly extending collar 25. The collar forms a surface that allows automated handling of the case. Furthermore, the housing is further preferably essentially free of protrusions, extending beyond the ridges to allow for rotational independent mechanical gripping.

[0068] Preferably, the caps and cases are further configured / dimensioned to prevent nesting of cases and / or caps, which would impede automated packaging processes. To prevent nesting (also referred to as train formation), the cases and / or caps further comprise one or more members, e.g., lips, that limit the formation of flush contact areas between the caps and / or cases. Figure 12 shows one embodiment, where the cases comprise an inwardly extending lip 12, which reduces train assembly by preventing the bottom of an adjacent case from extending into the case.

[0069] As disclosed herein, the cases and caps may have particular advantages with respect to packaging a product in a sterile package that is ready for direct use by an end user. The packaged product advantageously allows for sterilization of the product in the package while providing effective tamper protection through one or more elements that provide a visual indication of an opening event and / or elements that physically impede tampering.

[0070] 12 shows a method of packaging a product, preferably a needle assembly. The method 200 comprises a step 201 of closing a containment volume around the product to be packaged by connecting a case 2 and a cap 3 as disclosed herein. Advantageously, the method may comprise a step 202 of exposing the packaged product to a gaseous sterilant after connecting the cap and the case.

[0071] Although features have been described herein as part of the same or separate embodiments for purposes of clarity and conciseness of description, it will be understood that the scope of the invention includes embodiments having all or any combination of the described features.

[0072] For example, in some embodiments, a packaged needle assembly product is provided that includes a case and cap arranged in an assembled configuration forming an enclosure for the needle assembly, and an adhesive label attached to an exterior surface of the enclosure, the label extending across at least a portion of a circumferential gap between an edge of the cap and an edge of the case, thereby sealing the hard shell packaging product, the label having a perforated section with a plurality of perforation lines that extend across the gap at an angle (θ) from a first end terminating at or beyond the edge of the cap to a second end terminating at or beyond the edge of the case, the case and cap configured for sliding engagement into the assembled configuration, the case and cap having circumferentially overlapping sidewall sections, and the hard shell packaging product having one or more radial channels that extend longitudinally between the overlapping sidewall sections to form a gas passageway into the interior of the enclosure.

[0073] In some embodiments, the channel is defined at least in part by one or more protrusions extending from an inner surface of the circumferentially overlapping wall section of the cap toward a corresponding overlapping wall section of the case, and / or from an outer surface of the circumferentially overlapping wall section of the case toward a corresponding wall section of the cap.

[0074] When interpreting the appended claims, it should be understood that, unless expressly stated otherwise, the term "comprising" does not exclude the presence of other elements and acts than those recited in a given claim, the term "a" or "an" preceding an element does not exclude the presence of a plurality of such elements, any reference sign in a claim does not limit the scope of the claim, and a plurality of "means" may be represented by the same or different items, structures or functions, and any of the disclosed devices or parts of devices may be combined together or separated into further parts. However, the mere fact that certain means are recited in mutually different claims does not indicate that a combination of these means cannot be used to produce an advantage. Thus, the present embodiments may include all operative combinations of the claims, and each claim may in principle refer to any preceding claim, unless clearly excluded by the context. [Explanation of symbols]

[0075] 1 hard shell packaged product, 2, 21 case, 3, 32 cap, 4 enclosed volume, 5 radial channel, 6, 6a, 6b single-use means, 7 projection, 8 push member, 9 outer hand grip member, 10 retention member, 11 ridge, 12 lip, 13 label, 20, 30 side wall section, 31 first cap part, 32 second cap part, 33 interconnecting member, 34, 35 interlocking element, 102 hub, 101 cannula, 100 needle assembly, P gas passage

Claims

1. A hard-shell packaging product (1) for a needle assembly (100) comprising a cannula (101) extending from a hub (102) for receiving a corresponding portion of a syringe, the hard shell product comprising a case (2) and a cap (3) configured for sliding engagement into an assembled arrangement defining an enclosed volume (4) for the needle assembly (100); the case and the cap having circumferentially overlapping sidewall sections (20, 30); one or more radial channels (5) extending longitudinally between said overlapping side wall sections and configured to define a gas passageway (P) to said enclosed volume.

2. 2. The hard shell packaging product of claim 1, further comprising one or more single-use means (6, 6a, 6b) for fastening said cap to said case.

3. The cap (3) at least a first cap part (31) comprising one or more single-use means (6, 6a, 6b) for fastening said cap to said case; a second cap part (32) connected to the first cap part by one or more interconnecting members (33) configured to be broken by displacing the second cap part (32) relative to the case (2) while maintaining an interlocking connection between the first cap part (31) and the case (2); 3. The hard shell packaging product according to claim 1, further comprising:

4. said channel (5) being at least partially defined by at least one protrusion (7); The protrusion is from the inner surface of the overlapping wall section in the circumferential direction of the cap (31) towards the corresponding overlapping wall section of the case (21); and from an outer surface of the overlapping wall section in the circumferential direction of the case (21) towards the corresponding wall section of the cap (32), 4. The hard shell packaging product according to claim 1, wherein the at least one of the first and second electrodes extends beyond the first and second electrodes.

5. 5. The hard shell packaging product according to claim 3 or 4, characterized in that one or more of the interconnecting members (33) for fixing the first cap part (31) to the case (2) are provided with interlocking elements (34, 35) configured to snap-engage into a locked position.

6. 6. The hard shell packaging product of claim 5, wherein each of the interconnecting member and the means for securing the first cap component to the case are configured to break under a force less than a snap disengagement force to release the interlocking element from the locked position.

7. 7. The hard shell packaging product of claim 1, wherein the case is configured to restrict the rotational freedom of the needle assembly along the longitudinal direction by providing one or more engagement surfaces arranged along the case or by an inner surface of the case.

8. 8. The hard shell packaging product of any one of claims 3 to 7, characterized in that the first cap part comprises one or more outwardly extending push members (8).

9. 9. The hard shell packaging product of claim 8, wherein one or more of said push members at least partially overlap said means (6) for fixing said first cap part to said case.

10. 10. The hard shell packaging product of claim 1, wherein at least one of the case (2) and the second cap part (32), preferably both, is provided with an outer manual gripping member (9) for displacing the second cap part relative to the case.

11. 11. The hard shell packaging product of claim 1, wherein the inner wall of the case (2) is provided with one or more retaining members (10), such as a circumferential rim, that engage the needle assembly to limit displacement of the needle assembly (100) along the longitudinal direction.

12. 12. The hard shell packaging product of claim 1, wherein the case has an outer section that is generally circular and devoid of protrusions and bounded by an outwardly extending ridge (11).

13. The hard shell package product according to any one of claims 1 to 12, characterized in that the case further comprises one or more lips (12) that limit the formation of a flush contact area between the outer and inner surfaces of the stacked cases (2-1, 2-2).

14. 14. The hard shell packaging product of claim 1, wherein the single-use component for securing the cap to the case comprises a label (13) extending circumferentially across the interface between the cap and the case.

15. 15. The hard shell packaging product of claim 14, wherein the label includes a plurality of perforation lines extending across the interface between the cap and the case.

16. A cap (3) and a case (2) for assembly into a hard-shell packaging product (1), such as a hard-shell packaging product for packaging a needle assembly according to any one of claims 1 to 15, comprising: the cap and the case defining an enclosure for a product stored in a coupled configuration; the case and the cap, in the coupled configuration, form circumferentially overlapping sidewall sections; One or more radial channels (5) are provided extending longitudinally between the overlapping side wall sections thereby providing a gas passageway to the needle assembly.

17. The cap is at least a first cap part (31) comprising means for fixing said cap to said case; a second cap part (32) connected to the first cap part by one or more interconnecting members (33) configured to be broken by displacing the second cap part (32) relative to the case while maintaining an interlocking connection between the first cap part (31) and the case (2); 17. The cap and case of claim 16, further comprising:

18. A packaged needle assembly (100) surrounded by a packaged product (1) according to any one of claims 1 to 15 or a cap (3) and a case (2) according to claims 16 or 17.

19. The packaged needle assembly of claim 18, further comprising a needle protector (103).

20. A method (200) for packaging a product, preferably a needle assembly (100), comprising: A method, characterized in that it comprises a step (201) of closing a containment volume around a packaged product by connecting a case (2) and a cap (3) according to any one of claims 1 to 19.

21. 21. The method of claim 20, further comprising exposing the product to a gaseous sterilant after connecting the cap and case (202).

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