Packaging, storage, and protection technologies for medical syringes and fluid pathway components.

Abstract

A syringe packaging system and related methods are described. The syringe packaging system may include a partition configuration defining multiple spaces, and a container configured to receive the partition configuration and multiple syringes inside. At least a portion of the multiple spaces may be configured to receive individual syringes of the multiple syringes inside. The syringes are received in an upright, substantially parallel configuration, and the partition configuration separates each individual syringe from one or more adjacent syringes. The syringe packaging system enables reduction of medical waste, improved recyclability, and minimization of the carbon footprint. A method for sterilizing multiple syringes contained in the packaging system is disclosed.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 465,342, filed on May 10, 2023, entitled "Packaging, Storage, and Protection Techniques for Medical Syringes and Fluid Path Components", the disclosure of which is hereby incorporated by reference in its entirety.

[0002] The present disclosure relates to packaging systems, storage solutions, and protection techniques and structures for the storage, sterilization, and shipping of medical devices. In certain aspects, these medical devices more particularly include syringes, fluid path components, and medical syringes useful for a variety of medical procedures and tests.

Background Art

[0003] Syringes and medical syringes designed to contain fluids such as contrast agents and saline are generally used to introduce fluids into a patient's body in a variety of medical diagnostic imaging procedures. These medical devices need to be manufactured, packaged, and delivered to customers such as hospitals, physicians, and other medical providers to promote sterility and structural integrity and keep the devices in a properly functioning state. Conventional syringe packaging systems and storage solutions can benefit from improvements that more effectively address these important considerations of sterility, durability, recyclability, and operability.

[0004] Syringe packaging must meet the sterility, durability, and labeling standards applicable in connection with the delivery of syringes to end-users or customers. Syringe packaging systems must be sufficiently resistant to events that impair the maintenance of sterility and to the ingress of foreign particles into the medical device or package. Furthermore, syringes and fluid pathway components are typically sterilized after being packaged in either individual packages or bulk packages containing multiple syringe components. Sterilization techniques may involve irradiation of packaged components with an electron beam or exposure to ethylene oxide. In addition, in connection with the storage and delivery of syringes, the packaging system must withstand scratches, slices, or other physical damage to the most critical structural parts of the syringe and withstand contamination of the sterile fluid pathway within the syringe. Furthermore, syringe packaging systems should be conveniently stackable or storeable in containers used to ship products to customers. The structural design of the packaging system should preferably be compatible with shelves or other storage areas commonly used for storing medical devices in end-user facilities such as imaging diagnostic rooms. Furthermore, there is a need for syringe packaging systems and solutions that require little to no special modifications to the fundamental structural design and function of the syringe itself.

[0005] Furthermore, conventional packaging systems utilize materials that are not easily recyclable or are not manufactured from sustainable sources. Consequently, the carbon footprint associated with packaging design and / or materials increases. [Prior art documents] [Patent Documents]

[0006] [Patent Document 1] International Publication No. 2022 / 035791 brochure [Patent Document 2] International Publication No. 2021 / 168076 brochure [Patent Document 3] International Publication No. 2023 / 244580 brochure [Patent Document 4] International Publication No. 2023 / 212177 Brochure [Patent Document 5] International Publication No. 2022 / 119837 brochure [Overview of the project] [Problems that the invention aims to solve]

[0007] Considering the above issues, improved technologies and solutions are needed for medical device packaging systems, particularly for the packaging, shipping, and storage of medical syringes. [Means for solving the problem]

[0008] In some embodiments, the syringe packaging system may include a partition configuration defining a plurality of spaces, and a container configured to receive the partition configuration and the plurality of syringes inside. At least a portion of the plurality of spaces may be configured to receive individual syringes of the plurality of syringes inside. The plurality of syringes may be received in an upright and substantially parallel configuration, and the partition configuration may separate individual syringes from one or more adjacent syringes.

[0009] In some embodiments, the syringe packaging system may further include a cover defining a plurality of openings, each opening configured to receive the distal end of one of the plurality of syringes. Each of the plurality of openings may include at least one circumferentially arranged slit around the outer circumference of each of the plurality of openings. Each of the plurality of syringes may include a clip portion located at its distal end, and each of the plurality of openings may be configured to receive the clip portion through it. The cover may include a body and a plurality of barriers extending vertically upward from the body, the body defining the plurality of openings. The plurality of openings may be arranged in a plurality of rows along the body, and each of the plurality of barriers may extend adjacent to at least one of the plurality of rows of openings. At least one of the multiple barriers, a first barrier, may extend along the edge of the main body and at least one second barrier may extend along the interior of the main body and at least one second barrier at a second distance from the main body, the second distance being longer than the first distance.

[0010] In some embodiments, the partition configuration may include a plurality of vertical walls and a plurality of horizontal walls intersecting the plurality of vertical walls and defining a plurality of spaces between them, and the cover may be configured to rest on the upper end surface of the partition configuration inside the container. The internal bottom surface of the container may be configured to support the proximal ends of a plurality of syringes, and at least a portion of the internal bottom surface may be inclined at an angle with respect to the external bottom surface of the container such that at least one proximal end of the plurality of syringes is at a different height from at least one other syringe. The internal bottom surface may include a first inclined portion extending in a first direction and a second inclined portion extending in a second direction different from the first direction. The first inclined portion may extend from a first end of the container, and the second inclined portion may extend from a second end of the container opposite to the first end. The first and second inclined portions may form a apex.

[0011] In some embodiments, a first portion of the plurality of spaces may be configured to receive individual syringes of the plurality of syringes inside, while a second portion of the plurality of spaces may be configured not to receive individual syringes inside. The second portion of the plurality of spaces may be arranged to surround the first portion of the plurality of spaces. The second portion of the plurality of spaces may have a smaller volume than the first portion of the plurality of spaces. At least a portion of each partition of the partition configuration may be formed from a material selected from the group consisting of cardstock, thick paper, corrugated cardboard, SBS paperboard, corrugated cardboard, polymer materials, biodegradable polymer materials, recycled pulp materials, and any combination thereof.

[0012] In some embodiments, a packaging system for sterilizing syringes may include a plurality of syringes, each syringe comprising a body forming a proximal and distal end, a plunger positioned within the body adjacent to the proximal end, and a tip at the distal end; and a partition configuration defining a plurality of spaces, at least a portion of which is configured to receive one of the plurality of syringes internally. Each of the plurality of syringes may be received in an upright, substantially parallel configuration, and the partition configuration may separate each individual syringe from one or more adjacent syringes. The packaging system may further include a cover configured to receive the distal ends of the plurality of syringes through, and a container configured to receive the plurality of syringes, the partition configuration, and the cover internally. The plurality of syringes, the partition configuration, and the cover may be received within the container such that each of the plurality of syringes is configured to be sterilized within the container by an external supply source.

[0013] In some embodiments, the inner bottom surface of the container may be configured to support the proximal ends of the syringes, and at least a portion of the inner bottom surface may be inclined such that the proximal end of at least one of the plurality of syringes is at a different height from at least one other of the plurality of syringes. At least one plunger of the plurality of syringes may be at least partially offset laterally from at least one other plunger of the plurality of syringes. The inner bottom surface may include a first inclined portion extending in a first direction and a second inclined portion extending in a second direction different from the first direction, and the first and second inclined portions may abut at their respective ends.

[0014] In some embodiments, the cover may include a body defining a plurality of openings, each of which may be configured to receive the distal end of one of a plurality of syringes. Each of the plurality of syringes may further include a clip portion connected to the distal end, and each of the plurality of openings may further be configured to receive the clip portion and the distal end of the plurality of syringes. The cover may further include at least one barrier extending vertically upward from the body, the at least one barrier separating at least a first portion of the plurality of openings from at least a second portion of the plurality of openings. The at least one barrier may include a plurality of barriers, which extend along the length of the body and separate the plurality of openings into a row.

[0015] In some embodiments, a method for sterilizing a plurality of syringes to be housed in a packaging system may include the steps of packaging the plurality of syringes within the syringe packaging system and irradiating at least a portion of the syringe packaging system with a sterilization irradiation beam directed substantially perpendicular to the longitudinal axis of the plurality of syringes. The syringe packaging system may include a partition configuration defining a plurality of spaces, a container configured to receive the partition configuration and the plurality of syringes internally, and an internal bottom surface of the container configured to support the proximal ends of the plurality of syringes. At least a portion of the plurality of spaces may be configured to receive individual syringes of the plurality of syringes internally. The plurality of syringes may be received in an upright, substantially parallel configuration, and the partition configuration separates individual syringes from one or more adjacent syringes. At least a portion of the internal bottom surface may be inclined at an angle with respect to the external bottom surface of the container such that at least one proximal end of the plurality of syringes is at a different height from at least one other syringe of the plurality of syringes. At least one plunger among the multiple syringes may be at least partially offset laterally from at least one other plunger among the multiple syringes.

[0016] In some embodiments, the sterile irradiation beam may include an electron beam sterile irradiation beam. The surface of at least one plunger of the plurality of syringes may receive a dose of the sterile irradiation beam substantially similar to the dose of the sterile irradiation beam received by at least one other surface of the plurality of syringes.

[0017] In some embodiments or aspects, this disclosure may be characterized by one or more of the following numbered sections:

[0018] Item 1. A syringe packaging system comprising a partition structure defining a plurality of spaces, and a container configured to receive the partition structure and a plurality of syringes therein, at least a part of the plurality of spaces being configured to receive individual syringes of the plurality of syringes, the plurality of syringes being received in an upright and substantially parallel configuration, and the partition structure separating each individual syringe from one or more adjacent syringes.

[0019] Item 2. The syringe packaging system according to Item 1, further comprising a cover defining a plurality of openings, each opening of the plurality of openings being configured to receive the distal end of one of the plurality of syringes therethrough.

[0020] Item 3. The syringe packaging system according to Item 2, wherein each of the plurality of openings comprises at least one slit disposed circumferentially across the outer periphery of each of the plurality of openings.

[0021] Item 4. The syringe packaging system according to Item 3, wherein each of the plurality of syringes comprises a clip portion located at the distal end, and each of the plurality of openings is configured to receive the clip portion.

[0022] Item 5. The cover comprises a main body and a plurality of barriers extending vertically upward from the main body, the main body defining the plurality of openings, the plurality of openings being arranged in a plurality of rows along the main body, and each of the plurality of barriers extending adjacent to at least one of the plurality of rows of openings. The syringe packaging system according to any one of Items 2 to 4.

[0023] Item 6. The syringe packaging system according to Item 5, wherein at least one first barrier of the plurality of barriers extends along an edge of the main body and extends away from the main body by a first distance, and at least one second barrier extends along the inside of the main body and extends away from the main body by a second distance, the second distance being longer than the first distance. <0​​Item 7. The partition structure includes a plurality of vertical walls and a plurality of horizontal walls that intersect the plurality of vertical walls and define a plurality of spaces between those walls, and the cover is configured to be placed on the upper end surface of the partition structure within the container, the syringe packaging system according to any one of Items 2 to 6.

[0025] Item 8. The inner bottom surface of the container is configured to support the proximal ends of the plurality of syringes, and at least a part of the inner bottom surface is inclined at an angle with respect to the outer bottom surface of the container such that at least one proximal end of the plurality of syringes is at a different height from at least another one of the plurality of syringes, the syringe packaging system according to any one of Items 1 to 7.

[0026] Item 9. The plunger of at least one of the plurality of syringes is at least partially offset laterally from the plunger of at least another one of the plurality of syringes, the syringe packaging system of Item 8.

[0027] Item 10. The inner bottom surface includes a first inclined portion extending in a first direction and a second inclined portion extending in a second direction different from the first direction, the syringe packaging system of Item 8 or 9.

[0028] Item 11. The first inclined portion extends from a first end of the container, and the second inclined portion extends from a second end of the container opposite the first end, the syringe packaging system of Item 10.

[0029] Item 12. The first inclined portion and the second inclined portion form a top, the syringe packaging system of Item 11.

[0030] Item 13. A first portion of the plurality of spaces is configured to receive the individual syringes of the plurality of syringes therein, and a second portion of the plurality of spaces is configured not to receive the individual syringes therein, the syringe packaging system according to any one of Items 1 to 12.

[0031] Item 14. The syringe packaging system of Item 13, wherein the second part of the multiple spaces is arranged to surround the first part of the multiple spaces.

[0032] Item 15. The syringe packaging system of Item 14, wherein the second portion of the multiple spaces has a smaller volume than the first portion of the multiple spaces.

[0033] Item 16. A syringe packaging system according to any one of items 1 to 15, wherein at least a portion of each partition of the partition configuration is formed from a material selected from the group consisting of cardstock, thick paper, corrugated cardboard, SBS paperboard, corrugated cardboard, polymer materials, biodegradable polymer materials, recycled pulp materials, and any combination thereof.

[0034] Item 17. A packaging system for sterilizing syringes, comprising: a plurality of syringes, each syringe comprising: a body forming a proximal end and a distal end; a plunger positioned within the body adjacent to the proximal end; and a tip at the distal end; a partition configuration defining a plurality of spaces, wherein at least a portion of the plurality of spaces is configured to receive one of the plurality of syringes inside, and each of the plurality of syringes is received in an upright, substantially parallel configuration, and the partition configuration separates each individual syringe from one or more adjacent syringes; a cover configured to receive the distal ends of the plurality of syringes through it; and a container configured to receive the plurality of syringes, the partition configuration, and the cover inside, wherein the plurality of syringes, the partition configuration, and the cover are received inside the container in such a manner that each of the plurality of syringes is sterilized inside the container by an external supply source.

[0035] Item 18. The packaging system of Item 17, wherein the inner bottom surface of the container is configured to support the proximal end of a syringe, and at least a portion of the inner bottom surface is inclined such that at least one proximal end of a plurality of syringes is at a different height from at least one other syringe of the plurality.

[0036] Item 19. The packaging system of Item 18, wherein at least one plunger of a plurality of syringes is at least partially offset laterally from at least one other plunger of a plurality of syringes.

[0037] Item 20. The packaging system of item 18 or 19, wherein the internal bottom surface comprises a first inclined portion extending in a first direction and a second inclined portion extending in a second direction different from the first direction, the first inclined portion and the second inclined portion abutting at their respective ends.

[0038] Item 21. The packaging system of any one of items 17 to 20, wherein the cover comprises a body defining a plurality of openings, each of which is configured to receive the distal end of one of a plurality of syringes.

[0039] Item 22. The packaging system of Item 21, wherein each of the plurality of syringes further comprises a clip portion connected to the distal end, and each of the plurality of openings is further configured to receive through the clip portion.

[0040] Item 23. The packaging system of item 21 or 22, wherein the cover further comprises at least one barrier extending vertically upward from the body, the at least one barrier separating at least a first portion of a plurality of openings from at least a second portion of the plurality of openings.

[0041] Item 24. The packaging system of Item 23, wherein at least one barrier comprises multiple barriers, the multiple barriers extending along the length of the body and separating the multiple openings into a row.

[0042] Item 25. A method for sterilizing a plurality of syringes to be housed in a packaging system, comprising the step of packaging the plurality of syringes in a syringe packaging system, wherein the syringe packaging system comprises a partition configuration defining a plurality of spaces, a container configured to receive the partition configuration and the plurality of syringes internally, and an internal bottom surface of the container configured to support the proximal ends of the plurality of syringes, wherein at least a portion of the plurality of spaces is configured to receive the individual syringes of the plurality of syringes internally, the plurality of syringes are received in an upright and substantially parallel form, and the partition configuration is connected to one or more adjacent syringes A method comprising the steps of: separating each individual syringe from a plurality of syringes, and having an internal bottom surface such that at least a portion of the internal bottom surface is inclined at an angle with respect to the external bottom surface of the container, and at least one plunger of the plurality of syringes is at least partially offset laterally from at least one other plunger of the plurality of syringes; and irradiating at least a portion of the syringe packaging system with a sterile irradiation beam directed substantially perpendicular to the longitudinal axis of the plurality of syringes.

[0043] Item 26. The method of Item 25, wherein the sterilization irradiation beam includes an electron beam sterilization irradiation beam.

[0044] Item 27. The method of Item 25 or 26, wherein the surface of at least one plunger of a plurality of syringes receives a dose of a sterile irradiation beam substantially similar to the dose of a sterile irradiation beam received by at least one other surface of the plurality of syringes. [Brief explanation of the drawing]

[0045] [Figure 1] This is a perspective view of a syringe packaging system according to one embodiment of the present disclosure. [Figure 2] Figure 1 is a partially exploded view of the syringe packaging system. [Figure 3]Figure 1 is a perspective view of the partition structure used to separate the cover and syringe in the syringe packaging system. [Figure 4] Figure 3 shows the cover, partition structure, and top view of the syringe. [Figure 5] Figure 3 shows the cover, partition structure, and exploded view of the syringe. [Figure 6] Figure 1 is a perspective view of the cover and partition configuration of the syringe packaging system. [Figure 7] Figure 1 is a perspective view of the cover of the syringe packaging system. [Figure 8] This is a top view of the cover in Figure 7, where the end barriers are not folded. [Figure 9] This is a top view of the cover in Figure 7, with the end barriers folded. [Figure 10] Figure 7 is a side view of the cover. [Figure 11] Figure 1 shows a perspective view of multiple syringe packaging systems packaged together in a bulk packaging configuration. [Figure 12] This is a partially transparent perspective view of a container for a syringe packaging system having an inclined internal bottom surface, according to another embodiment of the present disclosure. [Figure 13] Figure 12 is a partially transparent perspective view of a syringe packaging system including multiple syringes and covers along with the container. [Figure 14] This is a side view of the container in Figure 12 in an unassembled configuration. [Figure 15] Figure 13 is a partial transmission side view of the syringe packaging system, showing the direction of electron beam irradiation. [Figure 16] This is a partially transparent side view of a syringe packaging system having a container, showing the direction of electron beam irradiation, according to another embodiment of the present disclosure. [Figure 17] This is a perspective view of the container of a syringe packaging system according to another embodiment of the present disclosure. [Figure 18]Figure 17 is a partially transparent perspective view of a syringe packaging system using the container shown. [Figure 19] Figure 18 is an exploded view of the syringe packaging system. [Figure 20] This is a perspective view of a syringe packaging system showing a container and partition configuration according to another embodiment of the present disclosure. [Figure 21] This is a perspective view of another packaging system for a plurality of individually packaged and stored medical devices according to another embodiment of the present disclosure. [Figure 22] Figure 21 is a partial perspective view of the packaging system, showing the process of removing one of several stored medical devices from a larger number of stored medical devices. [Figure 23] Figure 21 is a perspective view of the packaging of multiple stored medical devices in the packaging system. [Figure 24] Figure 21 is a partially transparent side view of the packaging system. [Figure 25A] This is a perspective view of a syringe packaging according to another embodiment of the present disclosure. [Figure 25B] Figure 25A is a second perspective view of the syringe packaging. [Figure 26] This is a perspective view of a packaging system for disposable tube components according to another embodiment of the present disclosure. [Figure 27] Figure 26 is a partially transparent side view of a packaging system according to one embodiment of the present disclosure. [Figure 28] Figure 26 is a second partially transparent side view of a packaging system according to one embodiment of the present disclosure. [Figure 29] This is a perspective view of a packaging system for disposable tube components according to another embodiment of the present disclosure. [Figure 30A] This is a perspective view of packaging according to another embodiment of this disclosure. [Figure 30B] Figure 30A is a second perspective view of the packaging. [Figure 31]This is a partially transparent perspective view of packaging for a disposable fluid path component according to another embodiment of the present disclosure. [Figure 32] Figure 31 is a partially transparent perspective view of the packaging. [Modes for carrying out the invention]

[0046] In the specification, the singular forms "a," "an," and "the" refer to multiple objects unless the context otherwise explicitly indicates otherwise. The term "includes" is synonymous with "equipment." The term "at least" is synonymous with "more than or equal to."

[0047] As used herein, the terms “parallel” or “substantially parallel” mean the relative angle between two objects, such as elongated objects including a reference line (when extended to a theoretical intersection), which is 0° to 5°, or 0° to 3°, or 0° to 2°, or 0° to 1°, or 0° to 0.5°, or 0° to 0.25°, or 0° to 0.1°, including the values ​​listed.

[0048] Figures 1 to 10 show a syringe packaging system 10 according to one embodiment of the present disclosure. The packaging system 10 is configured to support multiple syringes 1 to be packaged, sterilized and shipped without damaging the multiple syringes 1 or their fluid pathways. The system 10 includes environmentally friendly packaging that protects the syringes 1 while minimizing the amount of material used and incorporating recyclable materials into the manufacturing process of the packaging system 10. The materials used are environmentally friendly materials where possible, meaning that they may include and / or be recyclable or reusable contents after consumer use. When the syringes 1 are removed from the system 10, the waste generated by the rest of the system 10 is minimized and / or easily recyclable.

[0049] Examples of syringes 1 that can be used in such a packaging system 10 include the angiography syringe disclosed in Patent Document 1, the disclosure of which Patent Document 1 is incorporated herein by reference in its entirety. Other medical devices and other configurations of syringes may be used in this system 10, and it is possible to understand how the system 10 can be adapted to accommodate different devices. However, syringe 1 is discussed in relation to the description of the packaging system 10 in this disclosure. For reference, each syringe 1 of a plurality of syringes includes a body 2 having a proximal end 3 and a distal end 4. In certain embodiments, a plunger 5 may be located at the proximal end 3 of the syringe, but the plunger 5 may be located anywhere longitudinally within the body 2, and it is understood that a nozzle 6 is located at the distal end 4, and the nozzle 6 is configured to connect to one or more fluid pathway components. The fluid or other drug may be placed in the body between the plunger 5 and the distal end 4, for example, if the syringe is in a pre-filled configuration, or after the syringe has been filled with the fluid or drug. In other embodiments, the syringe 1 may be empty, i.e., contain no liquid, and be filled after the end user transports and receives the packaging system 10. The syringe 1 may also have a clip 7 or connector member located within the nozzle 6. This example is described in Patent Document 2, and the disclosure of that international patent application is incorporated herein by reference in its entirety. By using the packaging system 10 described herein, the syringe 1 can be sterilized and transported to an end user such as a hospital.

[0050] According to various embodiments, multiple syringes 1 may be packaged in the form of a “sterile fluid pathway.” As used herein, the term “sterile fluid pathway” means that the internal parts of the syringe 1 and other medical devices, i.e., the parts of the medical device that come into contact with the fluid in the fluid pathway, are substantially isolated from the atmospheric environment by sealing the nozzle 6 with, for example, a cap or other sealing member, thereby allowing the contents inside the syringe 1 to be isolated from potential microbial contaminants during shipping and syringe setup. Once the internal parts are substantially isolated, the syringe 1 or medical device component may be subjected to a sterilization process to sterilize the surface and internal volume of the syringe 1 or medical device component, for example, by exposure to a sterilizing compound such as ethylene oxide gas, or by irradiation with a sterilizing beam such as an electron beam (commonly referred to as an “e-beam”). The sterilized syringe 1 or medical device component can be shipped and handled without concern that the internal fluid pathway may come into contact with any microbial contaminants and that the sterilization of the surface and internal volume is maintained. The sterile fluid pathway configuration requires only the internal fluid pathway surface and volume to be maintained in a sterile environment; the syringe 1 or other external components of the medical device do not need to be maintained in a sterile environment. Such a configuration can reduce costs because it requires less surface area to maintain a sterile environment, while simultaneously ensuring patient safety and reducing exposure to microbial contamination.

[0051] Referring first to Figures 1 and 2, according to one embodiment, the packaging system may include a bulk container 12, such as a box, to hold a plurality of syringes 1 and other parts of the system 10 inside. According to various embodiments, the plurality of syringes 1 may be held in an upright, substantially parallel configuration. The system 10 also includes a partition configuration 14 for separating the syringes 1 and a cover 16 extending over the syringes 1, these features of which are described in more detail below. The container 12 is shown as a box that may be made from materials such as corrugated cardboard, cardstock, thick paper, SBS cardboard, corrugated cardboard, polymer materials, biodegradable polymer materials, recycled pulp-based materials, and any combination thereof, or other suitable materials for supporting and securing the syringes 1 when placed inside. In some embodiments, the container 12 or part thereof may be made from biodegradable products, recyclable products, or used / recycled products to enhance the environmentally friendly nature of the packaging system 10. The container 12 includes side walls 18 and forms a lid 20 and flap 22 for opening the container 12 and accessing the syringe 1 through the upper end of the container 12. The container 12 also includes a bottom wall 24 that can support the proximal end 3 of the syringe 1 inside the container 12.

[0052] Referring to Figures 2 to 6, partition configurations 14 are shown to prevent syringe 1 from coming into contact with adjacent syringe 1 during packaging, shipping, and storage. Such partition configurations 14 can prevent scratches on the external surface of the syringes, damage or breakage of various syringe features during shipping and storage. The partition configuration 14 is configured to form a grid-like or matrix structure that defines a plurality of receiving spaces 30 for holding at least a portion of the syringe 1 inside. The partition configuration 14 includes vertical walls 26 and horizontal walls 28 that define the receiving spaces 30 for receiving at least a portion of the body 2 of the syringe 1. As shown, the vertical walls 26 extend substantially parallel to each other, and the horizontal walls 28 extend substantially parallel to each other. The walls 26, 28 are arranged to intersect, and an angle of 90 degrees may be defined at the intersections. These intersections define the receiving spaces 30 for the syringes 1. The vertical walls 26 are positioned relative to the horizontal walls 28 to isolate one syringe 1 from other syringes within a single receiving space 30. The vertical walls 26 are shown intersecting the horizontal walls 28 at a 90° angle, but other arrangements may be considered, as long as the various wall intersections define sufficient space to hold and isolate syringe 1 or another medical device. The partition structure 14 may be manufactured from corrugated cardboard, cardstock, or any other suitable textile product as described herein. In some embodiments, at least a portion of the partition structure 14 may be made from recyclable or recycled / used material to enhance the environmentally friendly nature of the packaging system 10. The partition structure 14 may also be foldable, meaning that the partition structure can be folded flat at or near the intersection of the vertical walls 26 and the horizontal walls 28. This allows the partition structure 14 to be folded back on itself to occupy less space when not in use inside the container 12, such as when placed in a waste or recycling container. In some embodiments, the partition configuration 14 may be reusable and / or recyclable. In other embodiments, the walls 26, 28 may have corresponding slots and pegs so that they can be assembled as shown and disassembled into individual wall components for immediate recycling or disposal.As shown in Figures 3, 5, and 6, in certain embodiments, the vertical walls 26 and / or horizontal walls 28 have tapered ends 32, but in other configurations, the vertical walls 26 and / or horizontal walls 28 may have vertical angles. The ends 32 may have a straight edge 34 and two inclined edges 36 that define the taper. The exact shape and size of the taper can be determined by the size of the syringes 1 or medical devices held within the partition configuration 14 so that each individual syringe 1 may remain isolated from other syringes 1 in the system. The vertical walls 26 and horizontal walls 28 are sized such that movement or rattling of the container 12 during transport is minimized, and individual syringes 1 only come into contact with adjacent walls 26, 28 instead of other syringes 1, thus preventing adjacent syringes from coming into contact with each other and potentially scratching or otherwise damaging the surface of one or both syringes. In various embodiments, the ends of the partition structure 14 are open, which means that a syringe 1 positioned along one of these ends has its receiving space 30 further defined by one of the side walls 18 of the container 12.

[0053] Referring to Figures 2 to 10, one embodiment of the cover 16 is shown. The cover 16 is configured to be positioned at the upper end of the partition structure 14 to secure the distal end 4 of the syringe 1 and to minimize both longitudinal and lateral movement of the syringe during shipping and handling of the packaging system. By securing the distal end 4 of the syringe 1 with the cover 16, the syringe 1 can be held upright and substantially immobile within the container 12. The cover 16 has a body 38 that defines a plurality of openings 40 for receiving at least a portion of the distal end 4 of the syringe 1 through. The openings 40 can secure the distal end 4 by friction fitting. In certain embodiments, the shape of each opening 40 may be such that the nozzle 6 can open the opening 40 when the cover 16 is placed in the packaging system 10 and the syringe 1 is inserted. In various embodiments, the openings 40 may be secured around the nozzle 6 or a narrower portion of the distal end 4 after the end of the nozzle 6 has passed through the opening and secured the syringe 1. In certain embodiments, the opening 40 may include one or more slits 42 extending radially outward with respect to the outer circumference of the opening 40 to provide some flex when, for example, the distal end 4 is pressed through the opening 40. Such a configuration can accommodate a clip 7 which may be wider than the nozzle 6. For example, the slits 42 may allow insertion of at least a portion of a flexible leg or other feature associated with the clip 7. In the figures, for clarity, only portions of the opening 40 and slits 42 are labeled. As shown in Figures 8 and 9, portions of the multiple openings 40 may be arranged in rows along the body 38 of the cover, so that the syringes 1 are arranged in rows within the container 12, for example, when the syringes 1 are held within the partition configuration 14. In other embodiments, different arrangements may be used to house the syringes 1 within the container 12. For example, the openings 40 may be arranged in a circular, square, rectangular, or elliptical arrangement. In such cases, the shape and arrangement of the partition configuration 14 may also be modified to accommodate the syringes 1 and the cover 16.

[0054] According to various embodiments, the cover 16 may also include one or more barriers 44 for separating rows of openings from each other, positioning the cover 16 within the packaging system 10, and holding the cover in place relative to the packaging system 10. As shown, the cover 16 may include a plurality of internal barriers 46, such as the two internal barriers 46 shown in Figures 6, 7, and 10, and two end barriers 48, each barrier 46, 48 extending parallel to each other. The internal barriers 46 extend along the inner portion of the body 38, and the end barriers 48 extend along the outer edge of the body 38. The barriers 44 may further serve to isolate the distal end 4 of the syringe 1 from each other. As shown in various embodiments, the internal barriers 46 may extend from the body 38 at a first distance D1, and the end barriers 48 may extend at a second distance D2 which is shorter than the first distance D1. The lengths of distances D1 and D2 are such that they extend beyond the distal end 4 of the syringe 1 held within the cover 16. This ensures that the syringe 1 is held within the container 12 without significant movement and prevents the distal end 4 of the syringe 1 from contacting the upper end surface or lid 20 of the container 12 during shipping and storage. Furthermore, the multiple internal barriers 46 and end barriers 48 of the cover 16 can provide improved structural integrity to the lid 20 of the container 12, increasing the weight-bearing load and preventing the upper end of the container 12 from collapsing during shipping and storage. Any number of internal barriers 46 can be specified depending on the number of syringes 1 held in the cover 16. In other embodiments, the end barriers 48 may be omitted. In these embodiments, the side walls 18 of the container 12 can serve as de facto end barriers 48 of the cover 16.

[0055] As shown in Figure 8, in some embodiments, the body 38 of the cover 16 may include different folds 50, 52 to form barriers 46, 48. Internal folds 50 and 51 may be provided along the internal length of the body 38. The internal folds define the first side 46A and the second side 46B of the internal barrier 46. By folding the body 38 at the internal folds 50 and 51, the first side 46A comes into contact with the second side 46B to form the internal barrier 46. An end fold 52 may be provided at a distance from the outer edge of the body 38 so that the end barrier 48 can be folded into a predetermined position at the end of the body 38. In other embodiments, the cover 16 has barriers 46, 48 that extend from the body 38 without requiring any part of the body 38 to be folded.

[0056] Referring to Figures 1 to 10, the packaging system 10 can be assembled by inserting a partition structure 14 into the container 12. The syringe 1 can then be individually inserted into a receiving space 30 formed between the vertical wall 26 and the horizontal wall 28 of the partition structure 14. The cover 16 may then be folded, with the folded cover 16 positioned at the upper end of the partition structure 14, thereby allowing the distal end 4 and / or clip 7 of the syringe 1 to be pushed through one of the openings 40 formed in the body 38 of the cover 16. The flap 22 and lid 20 of the container 12 are then closed. The barriers 46, 48 are sized to abut against the inner surface of the lid 20 without interfering with the closure of the flap 22 and lid 20 when the container 12 is in the closed position. The container 12 can be further secured by sealing the lid 20 with tape, adhesive, staples, or other known methods. Referring to Figure 11, individual sealed containers 12 may be placed together with other containers 12 in a larger bulk shipping container 54 for sterilization and / or shipping. The bulk shipping container 54 may be loaded onto a pallet together with other bulk shipping containers, or it may be shipped individually. The bulk shipping container 54 may be further shrink-wrapped or packaged to facilitate bulk shipping. According to various embodiments, when the multiple syringes are packaged and sealed in the containers 12, or when the multiple containers 12 are packaged into the bulk shipping container 54 individually or while loaded onto a pallet, they may be sterilized using a sterilization method such as exposure to ethylene oxide or electron beam irradiation. Using such a sterilization process, the inner surfaces of the multiple syringes may be sterilized as needed for a sterilized fluid pathway packaging configuration.

[0057] Referring here to Figures 12-16, another container 56 according to another embodiment of the present disclosure is shown. Multiple syringes 1 may be held inside the containers 12, 56 described in the present disclosure and may be sterilized by a specific process such as electron beam ("e-beam") irradiation or exposure to a sterilizing agent such as ethylene oxide. As shown in Figures 15 and 16, the container 12 may be subjected to electron beam irradiation from the side, and the electron beam may pass through the container side wall 18, syringes 1, partition configuration 14 and cover 16 as necessary, see, for example, Figures 15 and 16, for the electron beam passing through these features. All elements held inside the containers 12, 56 may all undergo this sterilization process, and the inner portions of the sterilization fluid paths of the multiple syringes may be effectively sterilized. According to various embodiments, the packaging configuration of the multiple syringes 1 may affect the effectiveness and consistency of the sterilization process. For example, in some cases, the sterilization process may be affected by the thickness and overlap of the plungers 5 within the syringe body 2, meaning that the presence of the plungers 5 may affect the intensity of electron beam irradiation and exposure to electron beam irradiation when the beam passes through and interacts with the material associated with one or more plungers 5. That is, in a conventional packaging configuration where syringes are packaged side by side in a substantially parallel arrangement, plungers 5 in multiple syringes 1 may be located in the same lateral portion of the packaging configuration. When subjected to electron beam irradiation, the thickness and overlap of the plunger material may reduce the intensity of electron beam irradiation received by plungers near the inside of the packaging system compared to the intensity received by plungers near the outside of the packaging system. As a result, the packaging system may require additional or longer electron beam irradiation times to ensure sufficient sterilization of all plunger surfaces. To address this situation, according to certain embodiments, the container 56 may include an inclined inner bottom surface 58 for supporting the syringes 1, thereby causing the syringes 1 to be stepped or staggered within the container 56, and correspondingly, the plungers to be staggered or laterally offset within the container with respect to the longitudinal axes of the multiple syringes.The staggered arrangement of multiple syringes 1 inside the container 56 allows the electron beam to pass through fewer plungers 5 and less plunger material in the container 56 compared to when the syringes 1 are fixed at the same level. This means that the irradiation process is more effective because the electron beam is absorbed and passed through by less plunger material during the sterilization process, thus ensuring less exposure to the electron beam and a faster sterilization process.

[0058] Referring to Figures 12 to 15, according to a particular embodiment, the container 56 still has side walls 18, a lid 20, a flap 22, and a bottom surface 24, similar to the container 12 described above in relation to Figures 1 to 11. However, the container 56 may also include an inclined internal bottom surface 58 formed by a folded portion 62, as described herein. The folded portion 62 may be folded over itself within the container 56 such that an angle 60 is formed between the internal bottom surface 58 of the container 56 and the bottom surface 24 (referred to here as the external bottom surface), thereby resulting in an inclination of the internal bottom surface 58 with respect to the longitudinal axis of the container 56. The folded portion 62 includes a first side surface 64 that contacts the inner surface of the external bottom surface 24, a first fold 66, a second side surface 68 that contacts the side wall 18, and a second fold 69 that contacts the same side wall 18 as the second side surface 68. The first fold 66 is positioned to extend along a corresponding fold defined by the side wall 18 and the outer bottom surface 24, such that it gives an angle that allows the inner bottom surface 58 to be inclined with respect to the outer bottom surface 24. Other features and methods that result in an alternating upright packaging configuration of syringe 1 are also contemplated and are considered to be within the scope of this packaging embodiment. The assembly of the syringe packaging system utilizing the container 56 and the inclined inner bottom surface 58 may be the same as the syringe packaging system 10 described above in relation to Figures 1 to 11. That is, the syringe packaging system 10 may include the container 56 and one or more of the partition configuration 14 and cover 16. Due to the flexibility of the materials forming the partition configuration 14 and cover 16, the partition configuration 14 and cover 16 can function in the same manner as described above, even when the syringe 1 is alternating along the inclined inner bottom surface 58. Figure 14 shows one embodiment of the container 56 in an unfolded form.

[0059] Referring to Figure 16, another embodiment of the staggered syringe packaging system and arrangement is shown. Instead of having a single internal bottom surface 58 inclined in one direction as shown in Figure 13, according to this embodiment, the container 56 includes two internal bottom surfaces 58 inclined in opposite directions. Specifically, the internal bottom surface 58 includes a first inclined portion 70 and a second inclined portion 72. The first inclined portion 70 defines an angle 74 together with the bottom surface 24, and the second inclined portion 72 defines an angle 76 together with the bottom surface 24. Both inclined portions 70, 72 may intersect at a apex 78 along the internal bottom surface 58, allowing for a two-tiered arrangement of multiple syringes 1 along the chevron-configured internal bottom surface 58. Irradiation by electron beam sterilization perpendicular to the longitudinal axis of the container in this embodiment allows the beam to irradiate the staggered bodies of the plungers in the staggered syringes for effective and complete irradiation and sterilization. In this embodiment, the syringe 1 may be held within two partition configurations 14 and a cover 16. For example, the syringe 1 supported by the first inclined portion 70 may be held within the first partition configuration 14A, and the syringe supported by the second inclined portion 72 may be held within the second partition configuration 14B. The syringe 1 may also have separate covers 16A, 16B corresponding to the syringe 1 held on one of the inclined portions 70, 72. In other embodiments, as shown in Figure 16, a single partition configuration 14 and cover 16 may be bent to account for the difference between the inclined portions 70, 72, thereby allowing the single partition configuration 14 and cover 16 to be used with all of the syringes 1 in the container 56.

[0060] Referring to Figures 17, 18, and 19, another embodiment and configuration of the syringe container 80 is shown. According to this embodiment, the container 80 has a body 82 with a main body portion 84 and an upper body portion 86 extending from the main body portion 84 and including an upper end surface 88. The main body portion 84 is cubic and has a bottom surface 90 and side walls 92 extending therefrom. The upper body portion 84 has side walls 94 which may be positioned at a certain angle with respect to the side walls 92 of the main body portion 84. This configuration means that the upper body portion 86 is partially tapered in the direction extending inward from the main body portion 84. An opening cover 96 may extend downward from the upper end surface 88 over at least a portion of the front side wall 94 of the upper body portion 86 and at least a portion of the front side wall 92 of the main body portion 84. A perforation 98 may extend along all or part of the opening cover 96 to allow the opening cover 96 to be opened or pulled away from the container 80 in order to access the syringe 1 inside the container 80. As shown in Figure 18, multiple syringes 1 are located inside the container 80 with a partition configuration 14, such as the various partition configurations described herein. The tapered nature of the upper body portion 86 helps to secure the distal end of the syringe 1 and prevent movement of the syringe during shipping and handling, meaning that the cover 16 may be omitted due to potential interference between the barriers 46, 48 and the upper body portion 86. However, in certain embodiments, the cover 16 may be used as described herein, with appropriate modifications to fit the shape of the upper body portion 86. As illustrated, the syringes 1 and the partition configuration 14, and the cover 16, if present, may be mostly located within the main body portion 84, but may extend at least partially within the upper body portion 86. In other embodiments, the syringe 1 and the partition 14, and the cover 16 if present, may be entirely contained within the main body portion 84.

[0061] In some embodiments, the container 80 may be used as shelf box packaging, and the syringe 1 may include one or more dust caps associated with a medical connector, including a tamper-evident seal or an anti-tamper-evident seal to ensure the sterility of the syringe 1. Non-limiting examples of medical connectors are shown and described in Patent Document 2. Non-limiting examples of dust caps and anti-tamper-evident features are shown and described in Patent Documents 3 and 4, and the disclosures of these patents are incorporated herein by reference. Multiple containers 80 may be packaged in at least one bulk packaging, such as a shipping case. For example, in one embodiment, a plurality of six containers 80 may be packaged in a bulk packaging container for sterilization and shipping, and the internal fluid storage volume of the syringe 1 is sterilized using the sterilization fluid path configuration described herein. In other embodiments, the syringe 1 may be sterilized after being placed in the container 80 by electron beam irradiation of, for example, an individual container 80, a plurality of containers 80 packaged in a bulk packaging container, or a plurality of bulk packaging containers each containing a plurality of containers 80 loaded on a pallet for shipment. In yet another non-limiting embodiment, the syringe 1 may be individually packaged and sterilized before being placed in the container 80.

[0062] Referring to Figure 20, a packaging system 100 according to another embodiment of the present disclosure is shown. The packaging system 100 includes a container 102 which can be the same shape as the container 12 or container 80 described herein in relation to Figures 1 to 19. The container 102 includes side walls 114, a bottom surface 116, and a lid (not shown). According to various embodiments, the packaging system 100 may include a partition configuration 104 different from the partition configuration 14 described herein. The packaging system 100 includes a partition configuration 104 having a plurality of vertical walls 106 and a plurality of horizontal walls 108. The vertical walls 106 and horizontal walls 108 may have their respective slots and pegs for assembly, or the walls 106, 108 may be formed as a single unit. The walls 106, 108 may define receiving spaces 110 for holding syringes 1 and include secondary spaces 112 for isolating each syringe 1 and each syringe receiving space 110 from each other. As shown in Figure 20, the walls 106, 108 are molded so that the syringe is held completely upright within the receiving space 110. This means that in certain embodiments, the cover may be omitted. The walls 106, 108 also define a secondary space 112 which is not formed to receive the syringe 1. As shown, the secondary space 112 has a smaller volume than the syringe receiving space 110 and may have a smaller surface area and volume than the receiving space 110. It should be noted that in other non-limiting embodiments without departing from the scope of this disclosure, other shapes and sizes of the secondary space 112 may be used. As shown, the secondary space 112 is arranged to surround the individual receiving spaces 110. This arrangement allows the syringe 1 to move within its respective receiving space 110 and come into contact with one or more of the lateral walls 108 and / or longitudinal walls 108 during transport, but with buffer space between adjacently packaged syringes 1. The presence of the secondary space 112 ensures that only one syringe 1 is always in contact with any one of the walls 106, 108. In other words, by not positioning the syringe 1 in adjacent receiving spaces 110, there is no risk of the syringe being damaged by contact with the common walls 106, 108, which would otherwise allow contact between the bodies 2 of adjacently packaged syringes 1 via the common wall.The presence of the secondary space 112 also allows for some buffering and collapse volume to be generated if the container 102 is compressed or damaged during transport. For clarity, only the syringe 1, the vertical wall 106, the horizontal wall 108, the receiving space 110, and a portion of the secondary space 112 are shown in Figure 20.

[0063] Referring to Figures 21–24, another packaging system 116 is shown, which is a different, non-limiting embodiment of the present disclosure. The packaging system 116 is in the form of a shelf dispenser for container cartons 126 for distributing individually packaged syringes 1, packaged in a series of distinct packaging configurations. The packaging system 116 includes a container 118 having a front 120 with an open portion 122 and a closed portion 124. The syringe container carton 126 is removed through the open portion 122 by a tearing engagement between a perforation 128 between the individually packaged syringes 1 and a lip 130 extending from the closed portion 124. As shown in Figures 23 and 24, a plurality of individual syringe container cartons 126A, 126B, 126C…126n are connected to one another by strips that can be folded over themselves within the container 118 to reduce the overall size of the packaging. As shown in Figure 24, multiple syringe container cartons 126 are included in the strip, but other quantities are possible depending on the available shelf space, single-to-double syringe configuration, etc. To remove individual syringe container cartons 126A from the strip, the container cartons 126A are pulled outward and downward so that the lip 130 engages with the perforation 128, facilitating the tearable removal of the container cartons 126A from the strip. This process can be repeated for the total number of syringe container cartons 126 in the strip. As shown in Figure 23, in certain embodiments, spacers 132 can be included in the strip between syringe container cartons located at the rear end of the strip, so that the user can see when there are few syringe container cartons 126 left in a container 118 and it needs to be replaced with a new container 118. As shown, the spacers 132 may include an indicator "Refill Now" or other appropriate marking indicating that there are few syringe container cartons 126 remaining. The spacer 132 has a perforation 128 for separating it from the rest of the carton 126.The spacer 132 may be placed before the last syringe container carton 126 in the strip, or before the last two or last three syringe container cartons 126 as needed. Each syringe container carton 126 can hold individual syringes or other medical devices. The cartons 126 may be made of recyclable or biodegradable packaging materials to reduce the environmental impact at disposal. The syringe container cartons 126 may be individually sterilized and placed inside the container 118, or may be sterilized while inside the container 118 as described herein.

[0064] Referring to Figures 25A and 25B, an example of a single syringe sterile fluid route package configuration 134 according to another embodiment of the present disclosure is shown. The packaging may include a thermoformed plastic tray 136 having a release cover 138 provided across the opening of the tray 136 for accessing the syringe 1. The tray 136 is molded to include flanges and other molded features to tightly fit the features of the syringe 1 therein and minimize movement during shipping and handling. If different medical devices are included, the tray 136 may be formed to tightly fit the features of those devices in addition to the features of the syringe 1. The tray 136 protects the syringes during shipping and storage. In certain embodiments, the thermoformed tray may further include one or more indexing sections formed on the outside of the tray surface. The indexing sections may be configured to allow stacking of multiple packages 134 during packaging, shipping, and storage without damaging or scratching the syringes. After the removal of syringe 1, the thermoformed trays 136 may be stacked on top of each other to minimize storage space for used packaging material until the used packaging material can be removed and disposed of or recycled. According to various embodiments, the release cover 138 may be bonded to the tray 136 and may be made from any suitable material such as Tyvek, nylon, or other suitable medical packaging material, which is stable to the sterilization techniques described herein and allows for easy removal of the package contents after the cover 138 is peeled off.

[0065] Referring to Figures 26–28, another embodiment of the packaging configuration 140 for other fluid path components 150, such as connectors and / or tubing components. The packaging configuration 140 includes a container 142 with a front 144 having an open portion 146 and a closed portion 148. The open portion 146 may include a side wall pulled away from the front 144 to access the individually wrapped fluid path components 150. The individually wrapped components 150 may be sterile packaged or may utilize a sterile fluid path configuration. As shown in Figure 27, the individually wrapped components 150A, 150B, 150C…150n may be placed in a strip and separated by perforations or folds 152 that allow individual components 150A to be easily separated from the strip. The perforations 152 are solely for separating individual components 150A from the strip and are not intended to expose any component to the atmosphere before use. The strips may be arranged in a roll or zigzag configuration (as shown) within the container 142. In another embodiment shown in Figure 28, the individually wrapped components 150A, 150B, 150C...150n may be arranged individually within the container 142, so that a single component 150A can be removed as needed without the need to separate component 150A from the strip. In certain embodiments, the individual packaging may include a separate opening mechanism, such as a separate set of perforations or a peel-off configuration, to access the packaged fluid path components within it once removed from the container 142. In certain embodiments, the container 142 of the individually wrapped components 150 required to set up the fluid injection procedure may be stored on a shelf in the radiology room for easy access by technicians. The container 142 may be designed to sit on the shelf and distribute the individually wrapped components 150 according to the order of use during the setup procedure. For example, each container 142 may include markings such as numbers or letters to indicate the order of access for setup, so that technicians can place the containers 142 on the shelves in the order most convenient for distribution and setup.In certain embodiments, the container 142 may include an opening for accessing the individually wrapped components 150, for example, an access drawer near the bottom of the front of the shelf-top box that allows gravity supply to the access point of the packaged fluid path components. In other embodiments, such as when the individually wrapped components 150 are packaged as rolled or zigzag-configured strips, the container 142 may allow access to and removal of the individual components 150 from a configuration that allows access to a single outer component 150 for easy separation from subsequent components by separation at perforations, for example, the unfoldable rolled or zigzag-configured strips.

[0066] Referring to Figure 29, according to another embodiment, the suspended package configuration 154 may be used for easy access to individual fluid path components. Individually wrapped components 156 may be suspended from hooks 159 provided on a wall, shelf, or other fixture via hook holes 158. Other slots or holes may also be provided on the components 156 to facilitate suspension. The hook holes 158 can be formed in the package 156 without interfering with or contaminating the components wrapped within them. In another embodiment, the components may include hooks, and the package 156 may naturally form a hook shape around the hooks of the components to facilitate suspension. In one embodiment, individually wrapped components 156 may be suspended individually from hooks 159, for example, if the components 156 include a long fluid path. In another embodiment, a plurality of individually wrapped components 156 may be provided in a strip and separated by tearable perforations 160. Similar to other perforations, these perforations 160 are positioned to isolate only one component 156 from the other and do not function to open the packaging of either component 156. In certain embodiments, individual packages 156 may include a separate set of perforations or a separate opening mechanism, such as a peeling configuration, to access the packaged fluid path components within them.

[0067] Referring to Figures 30A to 32, a packaging configuration 162 for a multi-patient cassette 164 is shown. An example of the cassette 164 is shown and described in Patent Document 5, the disclosure of which is incorporated herein by reference in its entirety. The packaging configuration 162 includes a pre-formed or molded tray 166 having a release cover or lid 168 as described herein. The tray 166 may include inserts 170 formed of various recyclable or post-consumer contents that serve as retaining and engaging parts to hold and maintain the cassette 164 and fluid path components to prevent accidental movement and damage during packaging and shipping, and the formed shape of the tray 166 provides structural elements for protecting and managing the tubes during shipping and storage. The release cover 168 may be a polymer molding material such as Tyvek® to maintain a sterile barrier in the case of a non-sterile fluid path, or a non-sterile barrier in embodiments incorporating sterile fluid path components. The insert 170 can be made of cardstock, such as solid bleached sulfate (SBS) cardboard, to provide a means of managing the tubes during packaging, shipping, and storage to prevent damage or entanglement of the tubes within the tray 166. The material of the insert 170 can be recyclable or readily biodegradable, which can reduce landfill and disposal costs. As shown in Figures 31 and 32, the packaging configuration 162 may also include side walls 172 that provide structure and protection for the cassette 164 in the tray 166. The side walls 172 can be made of corrugated cardboard, cardstock, SBS cardboard, or similar materials as described above. Additional structural elements can enable secure stacking during bulk packaging and storage, maximize packaging volume, and / or minimize shift and movement during shipping.

[0068] Other embodiments of this disclosure may include methods for packaging and sterilizing a plurality of syringes 1 or other fluid path components included in a packaging system according to various embodiments described herein. According to various embodiments, the method may include packaging a plurality of syringes 1 in a syringe packaging system according to embodiments described herein and irradiating at least a portion of the syringe packaging system with a sterilization irradiation beam directed substantially perpendicular to the longitudinal axis of the plurality of syringes. In certain embodiments, the sterilization irradiation beam may include an electron beam sterilization irradiation beam. As described herein, according to certain embodiments, the plurality of syringes may be packaged in an alternating configuration such that the surface of at least one plunger of the plurality of syringes receives a sterilization irradiation beam dose substantially similar to that received by at least one other surface of the plurality of syringes. According to various embodiments, the plurality of syringes 1 may be packaged utilizing a sterilization fluid path configuration.

[0069] While specific embodiments of the apparatus of this disclosure have been described in detail, it will be understood by those skilled in the art that various modifications and alternatives to those details can be developed in light of the overall teachings of this disclosure. Accordingly, the specific configurations disclosed are for illustrative purposes only and do not limit the scope of the apparatus of this disclosure to the entire scope of the appended claims and all their equivalents to which they should be given. [Explanation of Symbols]

[0070] 1 Syringe, 2 Body, 3 Proximal end, 4 Distal end, 5 Plunger, 6 Nozzle, 7 Clip, 10 System, 12 Container, 14 Partition configuration, 14A First partition configuration, 14B Second partition configuration, 16 Cover, 18 Side wall, 20 Lid, 22 Flap, 24 Outer bottom, 26 Vertical wall, 28 Horizontal wall, 30 Receiving space, 32 End, 38 Body, 40 Opening, 42 Slit, 44 Barrier, 46 Internal barrier, 46A First side, 46B Second side, 48 End barrier, 50, 51 Internal fold, 52 End fold, 54 Bottom, 56 Container, 58 Internal bottom, 62 Folded portion, 64 First side, 66 First fold, 68 Second side, 69 Second fold, 70 First inclined section, 72 Second inclined section, 78 Top section, 80 Syringe container, 82 Main body, 84 Main body section, 86 Upper body section, 88 Upper surface, 90 Bottom surface, 92 Side wall, 94 Front side wall, 96 Opening cover, 100 Packaging system, 102 Container, 106 Vertical wall, 108 Horizontal wall, 114 Side wall, 116 Bottom surface, 110 Receiving space, 112 Secondary space, 116 Packaging system, 118 Container, 120 Front, 122 Open section, 124 Closed section, 126 Container carton, 128 Perforation, 130 Lip, 132 Spacer, 134 Single syringe sterile fluid path package configuration, 136 Tray, 138 Peel-off cover, 140 Packaging configuration, 142 Container, 144 Front, 146 Open section, 148 Closed section, 150 Fluid path component, 152 Perforation, 154 Hanging package configuration, 156 Component, 158 Hook hole, 159 Hook, 160 Perforation, 162 Packaging configuration, 164 Cassette, 166 Tray, 168 Lid, 170 Insert

Claims

1. A partition wall configuration that defines multiple spaces, The aforementioned partition structure and a container configured to receive multiple syringes inside itself, Equipped with, At least a portion of the plurality of spaces is configured to receive the individual syringes of the plurality of syringes inside itself, the plurality of syringes are received in an upright and substantially parallel form, and the partition configuration separates each individual syringe from one or more adjacent syringes. Syringe packaging system.

2. The syringe packaging system according to claim 1, further comprising a cover defining a plurality of openings, wherein each of the plurality of openings is configured to receive the distal end of one of the plurality of syringes.

3. The syringe packaging system according to claim 2, wherein each of the plurality of openings comprises at least one slit arranged circumferentially around the outer circumference of each of the plurality of openings.

4. The syringe packaging system according to claim 3, wherein each of the plurality of syringes is provided with a clip portion located at the distal end, and each of the plurality of openings is configured to receive the clip portion by inserting it.

5. The syringe packaging system according to any one of claims 2 to 4, wherein the cover comprises a body and a plurality of barriers extending vertically upward from the body, the body defining the plurality of openings, the plurality of openings being arranged in a plurality of rows along the body, and each of the plurality of barriers extending adjacent to at least one of the plurality of rows of openings.

6. The syringe packaging system according to claim 5, wherein at least one first barrier among the plurality of barriers extends along the edge of the main body and extends at a distance of first from the main body, and at least one second barrier extends along the interior of the main body and extends at a distance of second from the main body, the second distance being longer than the first distance.

7. The syringe packaging system according to any one of claims 2 to 6, wherein the partition wall configuration comprises a plurality of vertical walls and a plurality of horizontal walls that intersect the plurality of vertical walls and define the plurality of spaces between them, and the cover is configured to be placed on the upper end surface of the partition wall configuration inside the container.

8. The syringe packaging system according to any one of claims 1 to 7, wherein the inner bottom surface of the container is configured to support the proximal ends of the plurality of syringes, and at least a portion of the inner bottom surface is inclined at an angle with respect to the outer bottom surface of the container such that the proximal end of at least one of the plurality of syringes is at a different height from at least one other of the plurality of syringes.

9. The syringe packaging system according to claim 8, wherein at least one plunger of the plurality of syringes is at least partially offset laterally from at least one other plunger of the plurality of syringes.

10. The syringe packaging system according to claim 8 or 9, wherein the internal bottom surface comprises a first inclined portion extending in a first direction and a second inclined portion extending in a second direction different from the first direction.

11. The syringe packaging system according to claim 10, wherein the first inclined portion extends from the first end of the container, and the second inclined portion extends from the second end of the container opposite to the first end.

12. The syringe packaging system according to claim 11, wherein the first inclined portion and the second inclined portion form a top.

13. A syringe packaging system according to any one of claims 1 to 12, wherein a first portion of the plurality of spaces is configured to receive individual syringes of the plurality of syringes inside itself, and a second portion of the plurality of spaces is configured not to receive individual syringes inside itself.

14. The syringe packaging system according to claim 13, wherein the second portion of the plurality of spaces is arranged to surround the first portion of the plurality of spaces.

15. The syringe packaging system according to claim 14, wherein the second portion of the plurality of spaces has a volume smaller than the volume of the first portion of the plurality of spaces.

16. The syringe packaging system according to any one of claims 1 to 15, wherein at least a portion of each partition of the partition configuration is formed from a material selected from the group consisting of cardstock, thick paper, corrugated cardboard, SBS paperboard, corrugated cardboard, polymer material, biodegradable polymer material, recycled pulp material, and any combination thereof.

17. A packaging system for sterilizing syringes, A plurality of syringes, wherein each of the plurality of syringes is A main body forming the proximal and distal ends, A plunger positioned within the main body, close to the proximal end, The tip at the distal end, Multiple syringes equipped with, A partition wall configuration defining multiple spaces, wherein at least a portion of the multiple spaces is configured to receive one of the multiple syringes inside itself, each of the multiple syringes is received in an upright and substantially parallel form, and the partition wall configuration separates each individual syringe from one or more adjacent syringes, A cover configured to receive the distal ends of the plurality of syringes, A container configured to receive the plurality of syringes, the partition structure, and the cover inside itself, Equipped with, The plurality of syringes, partitions, and covers are arranged to be received within the container such that each of the plurality of syringes is sterilized within the container by an external supply source. Packaging system.

18. The packaging system according to claim 17, wherein the inner bottom surface of the container is configured to support the proximal end of the syringe, and at least a portion of the inner bottom surface is inclined such that the proximal end of at least one of the plurality of syringes is at a different height from at least one other of the plurality of syringes.

19. The packaging system according to claim 18, wherein at least one plunger of the plurality of syringes is at least partially offset laterally from at least one other plunger of the plurality of syringes.

20. The packaging system according to claim 18 or 19, wherein the internal bottom surface comprises a first inclined portion extending in a first direction and a second inclined portion extending in a second direction different from the first direction, and the first inclined portion and the second inclined portion abut at their respective ends.

21. The packaging system according to any one of claims 17 to 20, wherein the cover comprises a body defining a plurality of openings, each of which is configured to receive the distal end of one of the plurality of syringes.

22. The packaging system according to claim 21, wherein each of the plurality of syringes further comprises a clip portion connected to the distal end, and each of the plurality of openings is further configured to receive the clip portion through insertion.

23. The packaging system according to claim 21 or 22, wherein the cover further comprises at least one barrier extending vertically upward from the body, the at least one barrier separating at least a first portion of the plurality of openings from at least a second portion of the plurality of openings.

24. The packaging system according to claim 23, wherein the at least one barrier comprises a plurality of barriers, the plurality of barriers extending along the length of the body and separating the plurality of openings into a row.

25. A method for sterilizing multiple syringes housed in a packaging system, A step of packaging the plurality of syringes into a syringe packaging system, wherein the syringe packaging system A partition wall configuration that defines multiple spaces, The aforementioned partition structure and a container configured to receive multiple syringes inside, An internal bottom surface of the container configured to support the proximal ends of the plurality of syringes, wherein at least a portion of the plurality of spaces is configured to receive the individual syringes of the plurality of syringes inside itself, the plurality of syringes are received in an upright and substantially parallel form, the partition configuration separates each individual syringe from one or more adjacent syringes, and at least a portion of the internal bottom surface is inclined at an angle with respect to the external bottom surface of the container such that the proximal end of at least one of the plurality of syringes is at a different height from at least one other of the plurality of syringes, and the internal bottom surface is at least partially offset laterally from the plunger of at least one of the plurality of syringes. It has steps, The steps include irradiating at least a portion of the syringe packaging system with a sterile irradiation beam directed substantially perpendicular to the longitudinal axis of the plurality of syringes, A method that includes this.

26. The method according to claim 25, wherein the sterilization irradiation beam includes an electron beam sterilization irradiation beam.

27. The method according to claim 25 or 26, wherein the surface of at least one plunger among the plurality of syringes receives a dose of the sterile irradiation beam substantially the same as the dose of the sterile irradiation beam received by at least one other surface among the plurality of syringes.

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