Needle support with integrated tubing management

Abstract

Described herein are various embodiments and related methods of a needle and tubing organizing support system that can include one or more of a tray assembly configured to protect and retain a portion of a needle assembly and a securing mechanism. The tray assembly can include a tray body and a capturing recess extending along the tray body for at least partially containing a needle of the needle assembly. The tray assembly can further include a retention element and / or a sheath shaped to extend along a length of the capturing recess and encompass at least a portion of the needle of the needle assembly. The securing mechanism can be coupled to the tray body and configured to releasably secure a tubing of the needle assembly to the tray body.

Description

NEEDLE SUPPORT WITH INTEGRATED TUBING MANAGEMENTCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of the U.S. Provisional Patent Application Ser. No. 63 / 626,380 filed January 29, 2024, and titled “NEEDLE SUPPORT WITH INTEGRATED TUBING MANAGEMENT,” which is incorporated herein by specific reference.TECHNICAL FIELD

[0002] The subject matter described herein relates generally to a needle support, including integrated tubing management, and more specifically to a needle and tubing organizing support system for needle assemblies, including fill needles.BACKGROUND

[0003] A process of filling vials with a pharmaceutical product, such as a vaccine or drug product, and finishing the process of packaging the medicine for distribution is commonly referred to in the art as “fill and finish”. The fill and finish process can be a common bottleneck in the manufacturing and deployment of vaccines due to, for example, insufficient scalability and / or lengthy set-up protocols.

[0004] For example, the filling process can take place within an isolator in order to maintain sterility of the pharmaceutical product. Multiple vials can be filled at once in the isolator using multiple needles, with each needle connected to a pump, surge bag, or feed line. Current devices for protecting needles and managing tubing can be difficult to manipulate with one hand and can fail to provide sufficient protection of the needle. Aspects described herein relate generallyto needle and sheath organizing supports with integrated tubing management for fill needles that address deficiencies in currently available devices.SUMMARY

[0005] Systems, methods, and articles of manufacture are provided for needle organizing support, including integrated tubing management. The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims. While certain features of the currently disclosed subject matter are described for illustrative purposes, it should be readily understood that such features are not intended to be limiting. The claims that follow this disclosure are intended to define the scope of the protected subject matter.

[0006] In an aspect of the present disclosure, a system for needle and tubing organization is provided. The system includes a tray assembly configured to protect and retain a portion of a needle assembly. The tray assembly includes a tray body including at least a portion of the tray body extending along a first plane, a capturing recess extending along the tray body and forming an opening along the tray body, the capturing recess including a capturing wall spanning across the opening and protruding away from the tray body and the first plane. The capturing recess is configured to at least partially contain a needle of the needle assembly, a retention element comprising a first retention portion and a second retention portion, the first retention portion extending between a proximal first retention end and a distal first retention end, the proximal first retention end positioned along the tray body, the distal first retention end being offset from the tray body and the first plane, the second retention portion extending towards the capturing recess from the distal first retention end; and a sheath shaped to extend along a length of the capturingrecess and configured to encompass at least a portion of the needle of the needle assembly, at least a portion of the sheath configured to be releasably captured by the second retention portion and the tray body to assist with securing a position of the sheath relative to the capturing recess; and a securing mechanism coupled to the tray body and configured to releasably secure a tubing of the needle assembly to the tray body.

[0007] In another aspect of the present disclosure, a needle and tubing organizing support kit is provided. The kit includes a needle assembly, including a fill needle; and a tubing coupled at a first end to the fill needle; and a needle and tubing organizing support system. The needle and tubing organizing support system includes a tray assembly configured to protect and retain a portion of the needle assembly. The tray assembly includes a tray body, at least a portion of the tray body extending along a first plane; a capturing recess extending along the tray body and forming an opening along the tray body, the capturing recess comprising a capturing wall spanning across the opening and protruding away from the tray body and the first plane, and the capturing recess being configured to at least partially contain the fill needle of the needle assembly; a retention element including a first retention portion and a second retention portion, the first retention portion extending between a proximal first retention end and a distal first retention end, the proximal first retention end positioned along the tray body, the distal first retention end being offset from the tray body and the first plane, the second retention portion extending towards the capturing recess from the distal first retention end; and a sheath shaped to extend along a length of the capturing recess and configured to encompass at least a portion of the fill needle of the needle assembly, at least a portion of the sheath configured to be releasably captured by the second retention portion and the tray body to assist with securing a position of the sheath relative to thecapturing recess; and a securing mechanism coupled to the tray body and configured to releasably secure a tubing of the needle assembly to the tray body.

[0008] In another aspect of the disclosure, a tray assembly is provided. The tray assembly is configured to protect and retain a portion of a needle assembly, and the tray assembly includes a tray body, at least a portion of the tray body extending along a first plane, a capturing recess extending along the tray body and forming an opening along the tray body, the capturing recess including a capturing wall spanning across the opening and protruding away from the tray body and the first plane, the capturing recess being configured to at least partially contain a needle of the needle assembly, and a retention element configured to assist with securing a needle of the needle assembly within at least a part of the capturing recess.

[0009] In another aspect of the disclosure, a method for a needle and tubing organizing support system is provided. The method includes inserting a needle into a sheath, and coupling the sheath to a tray body of the needle and tubing organizing support system. The needle and tubing organizing support system can include a capturing recess extending along the tray body and forming an opening along the tray body, the capturing recess including a capturing wall spanning across the opening and protruding away from the tray body and the first plane, the capturing recess being configured to at least partially contain a needle of the needle assembly, and a retention element including a first retention portion and a second retention portion, the first retention portion extending between a proximal first retention end and a distal first retention end, the proximal first retention end positioned along the tray body, the distal first retention end being offset from the tray body and the first plane, the second retention portion extending towards the capturing recess from the distal first retention end, and the sheath being shaped to extend along a length of the capturing recess and configured to encompass at least a portion of the needle of the needleassembly, at least a portion of the sheath configured to be releasably captured by the second retention portion and the tray body to assist with securing a position of the sheath relative to the capturing recess.

[0010] It is understood that each aspect of the present disclosure herein can include any of the features, options, systems components, method steps, and possibilities recited in association with the any other aspect of the present disclosure or other embodiments set forth above or elsewhere within this application.DESCRIPTION OF DRAWINGS

[0011] The accompanying drawings, which are incorporated in and constitute a pail of this specification, show certain aspects of the subject matter disclosed herein and, together with the description, help explain some of the principles associated with the disclosed implementations. In the drawings,

[0012] FIG. 1 depicts a front view of an embodiment of a tray assembly of an example needle and tubing organizing support system, consistent with implementations of the current subject matter;

[0013] FIG. 2 depicts a front view of the needle and tubing organizing support system of FIG. 1 including example embodiments of a needle and a sheath coupled to the tray assembly;

[0014] FIG. 3 depicts a front view of the needle and tubing organizing support system of FIG. 1 including an example needle, sheath, and securing mechanism;

[0015] FIG. 4 depicts a perspective view of another example needle and tubing organizing support system including an example fill needle, sheath, and securing mechanism, consistent with implementations of the current subject matter;

[0016] FIG. 5 depicts a front view of an embodiment of the tray assembly of the needle and tubing organizing support system of FIG. 4, consistent with implementations of the current subject matter;

[0017] FIG. 6 depicts a perspective view of the tray assembly of the needle and tubing organizing support system of FIG. 4, consistent with implementations of the current subject matter;

[0018] FIG. 7 depicts a front view of an embodiment of the tray assembly of the needle and tubing organizing support system of FIG. 4, consistent with implementations of the current subject matter;

[0019] FIG. 8 depicts a side view of the tray assembly of the needle and tubing organizing support system of FIG. 4, consistent with implementations of the current subject matter;

[0020] FIG. 9 depicts a cross sectional view of the tray assembly of the needle and tubing organizing support system of FIG. 4, taken along lines A-A in FIG. 8, consistent with implementations of the current subject matter;

[0021] FIG. 10 depicts a back view of the tray assembly of the needle and tubing organizing support system of FIG. 4, consistent with implementations of the current subject matter;

[0022] FIG. 11 depicts a front view of an embodiment of the tray assembly of another example needle and tubing organizing support system with an embodiment of the securing mechanism, consistent with implementations of the current subject matter;

[0023] FIG. 12 depicts a front view of an example fill needle, example sheath, and example tubing that can be used with an embodiment of the tray assembly of a needle and tubing organizing support system, consistent with implementations of the current subject matter;

[0024] FIG. 13 depicts a front view of another example fill needle, example sheath, and example tubing that can be used with an embodiment of the tray assembly of a needle and tubing organizing support system, consistent with implementations of the current subject matter;

[0025] FIG. 14 depicts a front view of the example fill needle, sheath, and tubing of FIG. 12 in use with the tray assembly of FIG. 11 , consistent with implementations of the current subject matter;

[0026] FIG. 15 depicts a front view of the example needle, sheath, and tubing of FIG. 13 in use with the tray assembly of FIG. 11, consistent with implementations of the current subject matter;

[0027] FIG. 16 depicts a perspective view of another example needle and tubing organizing support system with securing mechanism attachment points, consistent with implementations of the current subject matter;

[0028] FIG. 17 depicts a perspective view of the needle and tubing organizing support system of FIG. 4, consistent with implementations of the current subject matter;

[0029] FIG. 18A depicts an example needle in use with a sheath, consistent with implementations of the current subject matter;

[0030] FIG. 18B depicts a cross sectional view of the example needle in use with an embodiment of the sheath of FIG. 18 A;

[0031] FIG. 19A depicts another example needle in use with an embodiment of the sheath, consistent with implementations of the current subject matter;

[0032] FIG. 19B depicts a cross sectional view of the example needle in use with an embodiment of the sheath of FIG. 19A;

[0033] FIG. 20A depicts another example needle in use with an embodiment of the sheath, consistent with implementations of the current subject matter;

[0034] FIG. 20B depicts a cross sectional view of the example needle in use with an embodiment of the sheath of FIG. 20A;

[0035] FIG. 21 A depicts another example needle in use with an embodiment of the sheath, consistent with implementations of the current subject matter;

[0036] FIG. 2 IB depicts a cross sectional view of the example needle in use with an embodiment of the sheath of FIG. 21 A;

[0037] FIG. 22A depicts another example needle in use with an embodiment of the sheath, consistent with implementations of the current subject matter;

[0038] FIG. 22B depicts a cross sectional view of the example needle in use with an embodiment of the sheath of FIG. 22A;

[0039] FIG. 23A depicts a perspective of a tubing connector, consistent with implementations of the current subject matter;

[0040] FIG. 23B depicts a front view of the tubing connector of FIG. 23A, consistent with implementations of the current subject matter;

[0041] FIG. 24 depicts a perspective view of the tray assembly of the needle and tubing organizing support system of FIG. 1, consistent with implementations of the current subject matter;

[0042] FIG. 25 depicts a front view of the tray assembly of the needle and tubing organizing support system of FIG. 1, consistent with implementations of the current subject matter;

[0043] FIG. 26 is a side view of the tray assembly of the needle and tubing organizing support system of FIG. 1, consistent with implementations of the current subject matter;

[0044] FIG. 27 is a cross-sectional view of the tray assembly of the needle and tubing organizing support system of FIG. 1, taken along lines B-B in FIG. 26, consistent with implementations of the current subject matter;

[0045] FIG. 28 is a front view of the tray assembly and securement mechanism of the needle and tubing organizing support system of FIG. 1 , consistent with implementations of the current subject matter;

[0046] FIG. 29 is a front view of the tray assembly, securement mechanism, needle, sheath, and tubing of the needle and tubing organizing support system of FIG. 1, consistent with implementations of the current subject matter;

[0047] FIG. 30 is a front view of the tray assembly, securement mechanism, needle, sheath, and tubing of the needle and tubing organizing support system of FIG. 1, consistent with implementations of the current subject matter;

[0048] FIG. 31 is a front view of the tray assembly, securement mechanism, needle, sheath, and tubing of the needle and tubing organizing support system of FIG. 1, consistent with implementations of the current subject matter;

[0049] FIG. 32 depicts a top perspective view of an example tray body of another embodiment of the needle and tubing organizing support system, consistent with implementations of the current subject matter; and

[0050] FIG. 33 is a bottom perspective view of the tray body of FIG. 32, consistent with implementations of the current subject matter;

[0051] When practical, similar reference numbers denote similar structures, features, or elements.DETAILED DESCRIPTION

[0052] The fill and finish process can be an important step in the pharmaceutical manufacturing process. For example, the fill and finish process can include containers (e.g., vials, pouches, flexible containers) for receiving and containing one or more pharmaceutical products. Such pharmaceutical products can include, for example, one or more of a vaccine, biological and a drug substance product. The pharmaceutical products can include one or more biocomponents, including fluids, solids, mixtures, solutions, and suspensions including, but not limited to, bacteria, fungi, algae, plant cells, animal cells, white blood cells, T-cells, cell media, protozoans, nematodes, plasmids, viral vectors, blood, plasma, organelles, proteins, nucleic acids, lipids, plasmids, carbohydrates, and / or other biological components, and the like. Examples of some common biological components include E. coli, yeast, bacillus, and CHO cells. Biological components can also comprise cell-therapy cultures and cells and microorganisms that are aerobic or anaerobic and adherent or non-adherent. The fill and finish process can also include packaging (e.g., safely packing and / or storing) the one or more pharmaceutical products for distribution. For example, the fill process can take place within an isolator (e.g., a clean air device that provides containment and separation of aseptic pharmaceutical processes from technical personnel and the surrounding work environment) and multiple containers can be filled at once using multiple filling devices (e.g., fill needles). Each filling device, for example, can be connected to a pump, surge bag, or feed line with its own fluid line (e.g., tubing). In other examples, each filling device with its fluid line can form a part of a fluid manifold assembly in fluid communication with a fluid samplingdevice connected to a surge bag. The filling devices (e.g.., fill needles) and associated fluid lines must be aseptically packaged for placement into the isolator. In some instances, the fluid line can become tangled within the aseptic package. Additionally, the filling device and associated fluid line in each aseptic package are often required to be arranged and connected within an isolator using a single hand, and management / organization of filling devices and their respective fluid lines can be difficult to manipulate. Additionally, filling devices (e.g., fill needles) can be fragile and can bend or become damaged if left unprotected.

[0053] Consistent with implementations of the current subject matter, the needle and tubing organizing support system is configured to efficiently and effectively protect various embodiments of a filling device, such as a fill needle (e.g., a needle that can couple to a fill line (e.g., tubing) for dispensing one or more fluids from the fluid line into one or more containers). The needle and tubing organizing support system can also organize various embodiments of a fluid line, such as a variety of different sized and shaped tubing that can be permanently or releasably coupled to an embodiment of a fill needle. The needle and tubing organizing support system can enable efficient and effective use of the needle and tubing organizing support system, such as allowing single-handed use of the needle and tubing organizing support system and / or one or more elements that can be coupled and / or used with the needle and tubing organizing support system. In some instances, a user may only have one hand available to manipulate objects within the isolator. In some instances, a tubing should be released from a tray assembly without being dropped onto the lower surface of the isolator and becoming contaminated and / or otherwise unusable. For example, the needle and tubing organizing support system can be coupled to a surge bag, pump, or feed line using a user's single hand. This can allow a user to manipulate the fluid line or tubing of the needle and tubing organizing support system without the risk of dropping orcontaminating the fluid line or tubing. Various embodiments of the needle and tubing organizing support system for securely organizing various embodiments of a needle assembly are described herein.

[0054] FIGS. 1-3 and 24-31 illustrate embodiments of a needle and tubing organizing support system 100 that is configured to protect and retain a portion of a needle assembly 188. For example, the needle assembly 188 can include a fill needle 190 and a length of tubing 170 coupled to the fill needle 190. As shown in FIGS. 1-3 and 24-31, the needle and tubing organizing support system 100 can include embodiments of a tray assembly 110 and a securing mechanism 140, as shown in FIGS. 3, 4, 16, 17, and 31 The tray assembly 110 can be configured to protect and retain a portion of an embodiment of the needle assembly 188, and the securing mechanism 140 can be configured to releasably secure the tubing of the needle assembly 188, as will be described in greater detail below. In some embodiments, the tray assembly 110 can include an integrated securing mechanism 140 such that the securing mechanism 140 forms a part of the tray assembly 110. In some embodiments, the securing mechanism 140 is coupled to the tray assembly 110, including releasably coupled to the tray assembly 110.

[0055] As shown in FIGS. 4 and 16, the connection between the tubing 170 and the fill needle 190 can be secured by a compression collar' device 192. Extension of the tubing 170 to achieve a desired length for the fill and finish process can be achieved by connecting two more tubing 170 via fluid connecter secured with compression collar device 192. Examples of compression collar device 192 and how various tubings and fluid components can be coupled thereto for leak-proof fluid connections is disclosed in U.S. Pat No. 11,371,634 issued on June 28, 2022, U.S. Pat No. 11,821,553 issued on November 21, 2023, and U.S. Pat No. 11,821,554 issued on November 21, 2023, which are incorporated herein by specific reference.

[0056] As shown in FIGS. 1-10, 24-29, 32 and 33 the tray assembly 110 can include a tray body 115, a capturing recess 130, and one or more retention elements 120. In some embodiments, the tray assembly 110 can also include a sheath 180 that is configured to encompass at least a portion of an embodiment of the fill needle 190 of the needle assembly 188. For example, an embodiment of the sheath 180 can include an elongated pocket that can receive and protect at least a part of the fill needle 190. In some embodiments, the needle and tubing organizing support system 100 can include a securing mechanism 140 and / or one or more securing mechanism attachment elements 150 that are configured to releasably secure an embodiment of the tubing 170 of the needle assembly 188 to the tray body 115, as will be described in greater detail below.

[0057] As shown in FIGS. 1-3 and 24-33, the tray body 115 can be formed of a single piece or multiple pieces coupled together, and can be formed out of one or more materials that are generally rigid. For example, the tray body 115 can be made of a rigid plastic and / or metal material. As shown in FIGS. 1-10 the tray body 115 can be generally rectangular in shape and can be substantially planar. Other shapes and configurations of the tray body 115 are within the scope of this disclosure. For example, at least a part of the tray body 115 can extend along a first plane and include an embodiment of a capturing recess 130 that is sized and shaped to assist with protecting and containing at least a part of an embodiment of the fill needle 190.

[0058] As shown in FIGS. 2-4 and 29-33 the capturing recess 130 can be configured to at least partially contain and / or surround an embodiment of the fill needle 190, such as an embodiment of the fill needle 190 that is positioned within a sheath 180 coupled to the tray body 115. As shown in FIG. 1, the capturing recess 130 can extend along the tray body 115, such as along and / or parallel to a longitudinal axis of the tray body 115. For example, the capturing recess130 can form and / or include an opening 131 along the tray body 115 and along the first plane. Thecapturing recess 130 can include a capturing wall 132 defining at least a pail of the capturing recess130. For example, the capturing wall 132 can span across the opening 131 and protrude away from the tray body 115 and the first plane. As shown in FIGS. 1 , 5, 6, 9, 10, 24, 25, 28, and 32-33 the capturing wall 132 can extend across and along the opening 131 in the tray body 115, as well as connect to one or more sides of the opening 131. At least a part of the capturing wall 132 can extend away from a bottom side 117 of the tray body 115, such as in a direction that is orthogonal to and / or non-parallel to the first plane. As such, the capturing wall 132 can define a volume of space within the capturing recess 130 for the protective sheath 180 and fill needle 190 to at least partially fit within.10059] In some embodiments, the capturing recess 130 can be formed as a depression, groove, channel, or indentation in the tray body 115 defined by the capturing wall 132. As shown in FIGS. 9 and 27 the capturing wall 132, and the capturing recess 130 as a whole, can include a cross-section having a curved shape and / or U-shape. Other cross-sectional shapes of the capturing wall 132 and / or capturing recess 130 are within the scope of this disclosure, such as one or more of a square, flat, V-shaped, and rectangular shape. For example, a curved cross-section of the capturing wall 132 and capturing recess 130 can assist with protecting the fill needle 190 by increasing contact and / or surrounding area between the capturing wall 132 and the fill needle 190. For example, contact area between the capturing wall 132 and the fill needle 190 can distribute force loads (e.g., pressure) more evenly along the fill needle 190, while also allowing the capturing recess 130 to fit a variety of fill needles 190 having a variety of shapes and sizes. By at least partially containing and / or surrounding the protective sheath 180 containing the fill needle 190, the capturing recess 130 can assist in protecting the fill needle 190 from damage (e.g., bending of the fill needle 190) and act as a support for the fill needle 190. In some embodiments, the capturingrecess 130 can be sized and shaped to receive a variety of fill needles 190 having a variety of shapes and sizes (e.g., varying diameters and / or lengths), as shown in FIGS. 18-22.

[0060] In some embodiments, the tray assembly 110 can further include one or more retention elements 120 formed along the tray body 115. For example, the retention elements 120 can be arranged around a perimeter of the capturing recess 130, such as along and / or adjacent to the opening 131. The retention elements 120 can be made of the same material as the tray body 115 or can be made of a different material (e.g., material that is more or less rigid). As explained in further detail below, retention elements 120 can assist with releasably securing an embodiment of the sheath 180 along the capturing recess 130, such as to secure and / or contain an embodiment of the fill needle 190 at least partly within the capturing recess 130. The retention elements 120 can include a variety of shapes and sizes for securing the protective sheath 180 along the capturing recess 130. For example, each retention element 120 can include one or more of a tab, a clip, and / or the like. As shown in FIGS. 1-3 and 24-33, the retention elements 120 can include at least one tab (e.g., extruding element) that protrudes away from a top side 118 of the tray body 115 and extends toward the capturing recess 130. As shown in FIGS. 24, 26, and 27, the retention element 120 can include a first retention portion 122 and a second retention portion 124. In some embodiments, the first retention portion 122 can extend between a proximal first retention end and a distal first retention end, where the proximal first retention end is positioned along the tray body 115 and the distal first retention end is offset from the tray body 115 and the first plane. The second retention portion 124 can extend toward the capturing recess 130 from the distal first retention end.

[0061] In some embodiments, the retention element 120 can be arranged to form a sheath receiving slot 138 between the retention element 120 and the tray body 115, as seen in FIGS. 24, 26, and 27. For example, the sheath 180 can be slid into this sheath receiving slot 138, as explainedin further detail below. At least a portion of the sheath 180 can be held within the sheath receiving slot 138 to retain the fill needle 190 at least partially within the capturing recess 130. As shown in FIGS. 1-3 and 24-33, the needle and tubing organizing support system 100 can include five retention elements 120, including one retention element 120 along the bottom of the capturing recess 130 and two retention elements 120 on each side of the capturing recess 130, however, fewer or more retention elements 120 can be included. For example, as shown in FIGS. 5-10, the needle and tubing organizing support system 100 can include seven retention elements 120, including one retention element 120 along the bottom of the capturing recess 130 and three retention elements 120 on each side of the capturing recess 130. The retention elements 120 may be uniform in size and shape along the tray body 115, however, one or more retention elements 120 can differ in size and / or shape along the tray body 115. For example, the bottom retention element 120, as shown in FIG. 29, can assist with retaining the sheath 180 within and / or along the capturing recess 130, such as preventing the sheath 180 from slipping out of the capturing recess 130 when the needle and tubing organizing support system 100 is held upright. The retention elements 120 along either side of the capturing recess 130 can assist with retaining the sheath 180 within and / or along the capturing recess 130, such as preventing the sheath 180 from falling out of the capturing recess 130 when the needle and tubing organizing support system 100 is held various orientations (e.g., upside down).

[0062] For example, one or more of the tray body 115, capturing recess 130, and retention element 120 can be formed as a single part, such as molded as a single part. In some embodiments, at least one of the tray body 115, capturing recess 130, and retention element 120 can be formed as a separate part that is coupled together (e.g., the retention elements are coupled to the tray body during manufacturing). In some embodiments, one or more of the tray body 115,capturing recess 130, and retention element 120 can be made out of the same or similar material, such as when the tray body 115, capturing recess 130, and retention element 120 form a single part. In some embodiments, one or more of the tray body 115, capturing recess 130, and retention element 120 can be made out of different materials.

[0063] In some embodiments, the tray body 115 can include a length of 10 inches, 12 inches, 14 inches, and / or a length less than 16 inches. In some embodiments, the tray body 115 can have a length that is greater than 8 inches. The tray body 115 can include a rectangular shape and / or have one or more of a variety of shapes and sizes. The tray body 115 can be made out of one or more materials, such as a polypropylene, polycarbonate, polyethylene, polyethylene terephthalate, polyvinyl chloride, and polystyrene, and / or made of HDPE therefore withstanding both Gamma Irradiation and Autoclaving.

[0064] In some embodiments, the capturing recess 130 can include a length of 8 inches, 10 inches, 12 inches, 14 inches, and / or a length less than 16 inches. In some embodiments, the capturing recess 130 can have a length that is greater than 6 inches. The capturing recess 130 can include an elongated and rounded shape and / or have one or more of a variety of shapes and sizes. The capturing recess 130 can be made out of one or more materials, such as a polypropylene, polycarbonate, polyethylene, polyethylene terephthalate, polyvinyl chloride, and polystyrene, and / or made of HDPE therefore withstanding both Gamma Irradiation and Autoclaving.

[0065] In some embodiments, the retention element 120 can include one or more of a variety of shapes and sizes for capturing (including releasably capturing) a variety of sheaths. The retention element 120 can be made out of one or more materials, such as a polypropylene, polycarbonate, polyethylene, polyethylene terephthalate, polyvinyl chloride, and polystyrene, and / or made of HDPE therefore withstanding both Gamma Irradiation and Autoclaving.

[0066] The sheath 180 can be sized to fit a variety of fill needles 190. The sheath 180 can include longer or shorter sizes to fit fill needles 190 of varying length. For example, the sheath 180 can be made of a 3 layer film, such as Thermo Scientific™ CX3-9 film, with a seam along the two side edges and the bottom edge, with an opening at the top of the sheath 180, as shown in FIGS. 18-22. The sheath 180 can also include a seam adjacent to but a distance away from the bottom of the sheath 180, forming a protective gap 182 at the bottom of the sheath 180. The protective gap 182 can be enclosed by seams on all four sides, and provides a barrier between a bottom portion of the fill needle 190 and a bottom portion of the sheath 180. As such, the protective gap 182 can protect the bottom portion of the fill needle 190 from poking through the sheath 180 and / or hitting the bottom of the capturing recess 130, which could contaminate and / or damage the fill needle 190. For example, the sheath 180 can include a length of 4 inches, 5 inches, 6, inches, 7 inches, 8 inches, 9 inches, 10 inches, 11 inches, 12 inches, and / or a length less than 14 inches. In some embodiments, the sheath 180 can have a length that is greater than 3 inches. The sheath 180 can include a rectangular shape and / or have one or more of a variety of shapes and sizes. The sheath 180 can be made out of one or more materials, such as a polymer like polyester, polyethylene, polypropylene, polymethyl methacrylate, elastomers, a CX3-9 film, tie layer and nylon. The sheath 180 can be made of a material that is not easily punctured by the needle, thereby reducing the risk of particulate contaminating the pharmaceutical product being filled and increasing patient safety.

[0067] For example, the sheath 180 containing at least a portion of an embodiment of the fill needle 190 (of a needle assembly 188) can be placed into the capturing recess 130 of the tray assembly 110 by sliding the sheath 180 down and along the capturing recess 130 (e.g., from the top of the capturing recess 130) and into and along the sheath receiving slots 138 (e.g., betweenthe tray body 115 and the retention elements 120). The sheath 180 can be removed by sliding the sheath 180 up and along the capturing recess 130 and receiving slots 138. In some embodiments, the sheath 180 can be removed by deforming and pulling the sheath 180 straight out of the capturing recess 130 and / or receiving slot 138, such as when the sheath 180 is formed of a flexible material and can deform to enable the sheath to be pulled away from the tray body 115(e.g., pulled in a directed normal to the front side 118 of the tray body 115). In some embodiments, the sheath 180 can be made of a stiffer material that resists deflection and is limited to being slid up and out of the capturing recess 130 as opposed to being pulled straight out. Embodiments of the sheath 180 that are formed of a stiff material can help retain the sheath 180 and fill needle 190 at least partially within the capturing recess 130, which can help protect the fill needle 190 until removal of the sheath 180 and / or fill needle 190 by a user. The sheath 180 containing fill needle 190 is retained within the capturing recess 130 by the retention elements 120 even when the fill needle 190 and the needle and tubing organizing support system 100 is rotated in all three rotational directions (pitch, yaw, and roll) thus enabling the fill needle 190 and the needle and tubing organizing support system 100 to be a robust solution for needle protection and organization.

[0068] As shown in FIGS. 1-3, 5-7, 10-11, 14-15, 24-25, and 28-33, the tray assembly 110 can include a mounting element 112 to assist with mounting the needle and tubing organizing support system 100 to a fixture (e.g., hanger, hook, etc.), such as part of a setup step for performing a fill process. In some embodiments, the mounting element 112 can include a hole through the tray body 115 and can be located along a top portion 116 of the tray body 115, as shown in FIG. 1-3, 5-7, 10-11. 14-15, 24-25, and 28-33. Other embodiments of the mounting element 112 can be included in the tray assembly 110, such as one or more of a hook, a hook and loop fabric, a magnet, and the like.

[0069] As shown in FIGS. 18-22, the protective sheath 180 and the capturing recess 130 can be sized to support a variety of needle sizes, including fill needles 190 with varying lengths and diameters. Different use cases may require different fill needles 190, and the universal size of the capturing recess 130 of the needle and tubing organizing support system 100 enables the needle and tubing organizing support system 100 to be used in a variety of use cases. For example, the needle 190 can include one or more of a 24 gauge needle or other suitable gauges. For example, the needle 190 can include an inner diameter of approximately 0.5 millimeter (mm) to approximately 7.0 mm. In some embodiments, the needle 190 can include a length of approximately 3 inches, approximately 4 inches, approximately 4.28 inches, approximately 4.41 inches, approximately 4.80 inches, approximately 5.25 inches, approximately 6.89 inches, and / or a length less than approximately 8.5 inches. In some embodiments, the needle 190 can have a length that is greater than 2.5 inches. The needle 190 can include a tubular shape and / or have one or more of a variety of profile and cross-sectional shapes. The needle 190 can be made out of one or more materials, such as a stainless steel, titanium, polyether ether ketone (PEEK), and niobium. In some embodiments, the needle 190 can include a coating (e.g., plastic coating).

[0070] Tubing 170 can be attached at one end to the fill needle 190, with another end loose for attachment to the surge bag, fill line, or pump. The length of tubing 170 can be unwieldy and benefits from organization and securement (e.g., during storage and / or before use) so that a user performing the fill and finish process can easily and quickly unpackage and use the elements of the needle and tubing organizing support system 100. For example, the tubing 170 can include one or more of a variety of tubing, such as tubing used in fill and finish processes. The tubing 170 can be made out of one or more materials (e.g., including materials having a variety of shore andhardness values), such as one or more of a silicone, a thermoplastic elastomer (TPE), and a polymer like polyvinylchloride, polyethylene, or polypropylene.

[0071] As shown in FIGS. 3, 4, 11, 14, 15, 17, and 28-31, some embodiments of the tray assembly 110 can include a securing mechanism 140. The securing mechanism 140 can be configured to releasably secure a tubing 170 of an embodiment of the needle assembly 188. For example, the securing mechanism 140 can keep tubing 170 untangled, protected, and organized. For example, the securing mechanism 140 can secure tubing 170 within an organized bundle, thereby preventing knots or kinks forming in the tubing, which can be damaging and interfere with the fill and finish process. As shown in FIGS. 1-3 and 24-31, the securing mechanism 140 can include a belt made of a separate piece of tubing. The securing mechanism 140 can extend across the middle of the tray body 115 to provide an even securement of the tubing 170 against the tray body 115. The securing mechanism 140 can be anchored or attached to the tray assembly 110 via securing mechanism attachment elements 150 located on the tray body 115. The securing attachment elements 150 may be located on wings or extensions of the tray body 115 as shown in FIGS. 1-3 and 24-31. The securing attachment elements 150 can include one or more slots, pinchpoints, holes, and the like. The securing mechanism 140 can be used to organize, contain, or manage tubing 170 attached to the fill needle 190, as explained in further detail below.

[0072] The securing mechanism 140 can be a variety of suitable mechanisms. In some embodiments, the securing mechanism 140 can be a belt made of the tubing 170 attached to the needle (as shown in FIG. 16). In this embodiment, the securing attachment elements 150 may be located on the tray body 115 adjacent to a comer of the tray body 115, as shown in FIG. 16. The securing attachment elements 150 can include one or more slots, pinch-points (e.g., an opening orcutout with a narrowing diameter that can apply a compressive force to a securing mechanism to hold it in place), holes, and / or the like.

[0073] In some embodiments, the securing mechanism can be tubing 170 attached to the fill needle 190 and excess length wound around the tray body 115 and fill needle 190. A loose end of the tubing 170 can be secured to itself using a tubing connector 175 (i.e. a device that fixes in place a portion of tubing 170 relative to another portion of tubing 170), as seen in FIGS. 23A-23B. In some embodiments, the tubing connector 175 can be shaped generally like a figure-eight and can include an enclosed loop and an open loop. An end of tubing 170 can be inserted into the enclosed loop of connector 175, and another portion of tubing 170 can be removably inserted into the open loop of connector 175 to thereby releasably and safely secure the tubing 170 to itself.

[0074] In some embodiments, the securing mechanism 140 can be a beaded belt (e.g. an elongated belt or tie with a varying diameter to form beads that can be secured within a loop at the end of the elongated belt or tie), as shown in FIGS. 4, 11, 14, 15, and 17. The securing mechanism 140 can extend across the middle of the tray body 115 to provide a balanced securement of the tubing 170 against the tray body 115. The securing attachment elements 150 may be located adjacent to the capturing recess 130 as shown in FIGS. 4-11, 14, 15, and 17. The securing attachment elements 150 may include slots, pinch points, holes, and the like.

[0075] As mentioned above, the tray assembly 110 can include a securing mechanism 140 and securing attachment elements 150 used to secure the tubing 170 against the tray body 115 for transport or storage. For example, the tubing 170 can be wound and placed in front of the capturing recess 130, as shown in FIGS. 14-17 and 30-31. The securing mechanism 140, such as a beaded belt or a separate piece of tubing functioning as a belt, can be secured around the tubing 170 to hold the tubing 170 against the tray body 115 for storage or transportation before use, asshown in FIGS. 16, 17, and 31. The securing attachment elements 150 can include holes or pinch points, as seen in FIGS. 1-3 and 24-31. The tubing 170 can also itself be used to secure itself to the tray body 115. For example, tubing 170 attached to the fill needle 190 can have its excess length wound around the tray body 115 and fill needle 190, and its loose end can be secured to itself using a tubing connector 175 as seen in FIGS. 23A-23B.

[0076] As shown in FIGS. 32 and 33, some embodiments of the tray assembly 110 can include at least one securing notch 155 that is configured to secure an embodiment of the securing mechanism 140 (such as shown in FIG. 31). For example, the securing mechanism 140 can include a separate tubing, cord, flexible elongated material, etc. The securing mechanism 140 can be configured to releasably secure tubing 170 (FIG. 31) of an embodiment of the needle assembly 188 (FIG. 31). For example, the securing mechanism 140 can keep such tubing 170 untangled, protected, and organized, as illustrated and discussed herein. For example, the securing mechanism 140 can include a piece of tubing that is separate from the tubing 170 of the needle assembly.

[0077] Each securing notch 155 can include an opening along a side of the tray body 115, and the opening can include and / or extend to a cutout having a circumference 157 that is sized to capture a part of the securing mechanism 140 (FIG. 31). As shown in FIGS. 32 and 33, at least one side of the tray body 115 can include a pair of securing notches 155, which can allow an embodiment of the securing mechanism to extend through a first securing notch 155a and a second securing notch 155b by extending between the first and second securing notches 155a, 155b. For example, the securing mechanism 140 can form a friction and / or compression fit within each of the first and second securing notches 115a, 155b, thereby securing a part of the securing mechanism to the tray body 115. As shown in FIGS. 32 and 33, both of the elongated sides of the tray body 115 can include a pair of securing notches 155 which can allow, for example, opposingends of an embodiment of the securing mechanism 140 to be efficiently and effectively secured to the tray body 115. For example, securing of a part of the securing mechanism 140 to a securing notch 115 can include pushing the securing mechanism through the opening and against the circumference 157 of the securing notch 115. Additionally, the securing notches 155 can allow for efficient and effective release of the securing mechanism 140 from the tray body 115 thereby allowing for efficient release (e.g., time efficient and / or user-efficient, such as single-handed release) of the securing mechanism 140 from the tray body 115. For example, releasing of a part of the securing mechanism 140 from the securing notch 115 can include pulling the securing mechanism 140 away from the circumference 157 and out the opening of the securing notch 115.

[0078] As shown in FIGS. 32 and 33, the elongated sides of the tray body 115 can include at least one curved indent 159 that is positioned adjacent at least one securing notch 155 and is shaped to capture at least a part of the securing mechanism 140 (FIG. 31). The curved indent 15 can assist with securing a position of the securing mechanism 140 along the associated elongated side of the tray body 115. The curved indent 159 can assist with securing the securing mechanism 140 in place to thereby assist the securing mechanism 140 with securing the tubing 170 (FIG. 31) of the needle assembly 188 (FIG. 31) to the tray body 115.

[0079] A needle and tubing organizing support kit can include a tray assembly 110, a fill needle 190, a sheath 180, tubing 170, and a securing mechanism 140. As shown in FIGS. 11-17 and 28-31, a needle and sheath organizing support kit can be assembled by first providing the tray assembly 110. The fill needle 190 can be placed within the sheath 180, and the sheath 180 (containing fill needle 190) can be placed into the capturing recess 130 of the tray assembly 110 by sliding the sheath 180 down into the capturing recess 130 and sliding portions of sheath 180 into the sheath receiving slots 138 defined by the retention elements 120 and the tray body 115.Tubing 170 connected to the fill needle 190 can be arranged into a bundle, which can then be placed over the fill needle 190 and sheath 180 on the tray assembly 110. The securing mechanism 140 can then be actuated to retain the sheath 180 and fill needle 190 at least partially within the capturing recess 130 and secure the bundled tubing 170 against the tray body 115 for organization and management of tubing. The assembled kit can then be placed within a sterile bag for transfer into an isolator. An end user in the fill and finish process can set up the needle and tubing organizing support kit within the isolator in approximately backwards order of the steps above. The needle and tubing organizing support kit can be placed into an isolator using the sterile bag and removed from the sterile bag. The user can then manipulate the securing mechanism 140, using only one hand if desired, to gain access to the bundled tubing 170. The user can manipulate the bundled tubing 170 to remove it from the tray body 115 and gain access to the sheath 180 containing fill needle 190. The user can separate the sheath 180 from the tray assembly 110 by sliding the sheath 180 upwards and out from the sheath receiving slots 138 formed by the retention elements 120 and the tray body 115. The user can then remove the fill needle 190 from the sheath 180, and be ready to start the fill and finish process.

[0080] The subject matter described herein can be embodied in systems, apparatus, methods, and / or articles depending on the desired configuration. The implementations set forth in the foregoing description do not represent all implementations consistent with the subject matter described herein. Instead, they are merely some examples consistent with aspects related to the described subject matter. Although a few variations have been described in detail above, other modifications or additions are possible. In particular, further features and / or variations can be provided in addition to those set forth herein. For example, the implementations described above can be directed to various combinations and subcombinations of the disclosed features and / orcombinations and subcombinations of several further features disclosed above. In addition, the logic flows depicted in the accompanying figures and / or described herein do not necessarily require the particular order shown, or sequential order, to achieve desirable results. For example, the logic flows may include different and / or additional operations than shown without departing from the scope of the present disclosure. One or more operations of the logic flows may be repeated and / or omitted without departing from the scope of the present disclosure. Other implementations may be within the scope of the following claims.

[0081] When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. References to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.

[0082] Spatially relative terms, such as, for example, “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature’ s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understoodthat the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.(0083] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” “or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, in some implementations, the phrase “approximately” may include + / - .03 mm, + / - .05 mm, or the like.

Claims

CLAIMSWhat is claimed is:

1. A needle and tubing organizing support system, comprising: a tray assembly configured to protect and retain a portion of a needle assembly, comprising: a tray body, at least a portion of the tray body extending along a first plane; a capturing recess extending along the tray body and forming an opening along the tray body, the capturing recess comprising a capturing wall spanning across the opening and protruding away from the tray body and the first plane, wherein the capturing recess is configured to at least partially contain a needle of the needle assembly; a retention element comprising a first retention portion and a second retention portion, the first retention portion extending between a proximal first retention end and a distal first retention end, the proximal first retention end positioned along the tray body, the distal first retention end being offset from the tray body and the first plane, the second retention portion extending towards the capturing recess from the distal first retention end; and a sheath shaped to extend along a length of the capturing recess and configured to encompass at least a portion of the needle of the needle assembly, at least a portion of the sheath configured to be releasably captured by the second retention portion and the tray body to assist with securing a position of the sheath relative to the capturing recess; and a securing mechanism coupled to the tray body and configured to releasably secure a tubing of the needle assembly to the tray body.

2. The needle and tubing organizing support system of claim 1, wherein the securing mechanism comprises a cylindrical belt or a tubing.

3. The needle and tubing organizing support system of claim 1, wherein the securing mechanism comprises a beaded cable or beaded tie.

4. The needle and tubing organizing support system of claim 1, wherein the securing mechanism comprises a tubing connector.

5. The needle and tubing organizing support system of claim 1, wherein the securing mechanism is a part of the tray body and configured to releasably secure a portion of the tubing to the tray body.

6. The needle and tubing organizing support system of claim 1, wherein the securing mechanism comprises an opening, pinch point, slot, or hole along the tray body.

7. The needle and tubing organizing support system of claim 1, wherein the sheath comprises an elongated pocket configured to encompass at least a portion of the needle.

8. The needle and tubing organizing support system of claim 7, wherein the pocket comprises an opening at a proximal end of the sheath that is configured to receive at least the portion of the needle.

9. The needle and tubing organizing support system of claim 1 , wherein the sheath is formed out of a first sheath material and / or a second sheath material, the second sheath material being more flexible than the first sheath material.

10. The needle and tubing organizing support system of claim 9, wherein at least a portion of the sheath, when formed of the first sheath material, is required to slide approximatelyparallel to and between the tray body and the second retention portion to releasably couple the sheath to the tray body.

11. The needle and tubing organizing support system of claim 9, wherein at least a portion of the sheath, when formed of the second sheath material, is configured to deform to releasably couple the sheath to the tray body and / or is configured to slide approximately parallel to and between the tray body and the second retention portion to releasably couple the sheath to the tray body.

12. The needle and tubing organizing support system of claim 1, wherein the retention element is located adjacent to the capturing recess.

13. The needle and tubing organizing support system of claim 1, wherein the tray assembly comprises more than one retention element, the more than one retention element located along more than one side of the capturing recess.

14. The needle and tubing organizing support system of claim 1, wherein the capturing recess is a groove, channel, depression, or indentation.

15. The needle and tubing organizing support system of claim 1, wherein the capturing recess has a curved and / or U-shaped cross- section.

16. The needle and tubing organizing support system of claim 1, wherein the retention element and tray body define a sheath receiving slot therebetween.

17. The needle and tubing organizing support system of claim 16, wherein the sheath receiving slot is configured to receive at least a portion of the sheath.

18. The needle and tubing organizing support system of claim 1, wherein the sheath is formed out of one or more of a polyester, polyethylene, polypropylene, polymethyl methacrylate, and an elastomer.

19. The needle and tubing organizing support system of claim 1, wherein the sheath is formed of a layered film and includes a side seam along at least a portion of each opposing sides of the sheath and an end seam along at least a portion of the end of the sheath.

20. The needle and tubing organizing support system of claim 19, wherein the end seam is offset from a distal end of the sheath to form a protective gap between the end seam and the distal end of the sheath, the protective gap configured to assist with protecting at least a distal end of the fill needle when the needle assembly is coupled to the needle and tubing organizing support system.

21. The needle and tubing organizing support system of claim 1, wherein the tray assembly further comprises a mounting element that is configured to assist with mounting the needle and tubing organizing support system to a fixture.

22. The needle and tubing organizing support system of claim 21, wherein the mounting element comprises a hole or opening through the tray body.

23. A needle and tubing organizing support kit comprising: a needle assembly, comprising: a fill needle; and a tubing coupled at a first end to the fill needle; and a needle and tubing organizing support system, comprising:a tray assembly configured to protect and retain a portion of the needle assembly, comprising: a tray body, at least a portion of the tray body extending along a first plane; a capturing recess extending along the tray body and forming an opening along the tray body, the capturing recess comprising a capturing wall spanning across the opening and protruding away from the tray body and the first plane, wherein the capturing recess is configured to at least partially contain the fill needle of the needle assembly; a retention element comprising a first retention portion and a second retention portion, the first retention portion extending between a proximal first retention end and a distal first retention end, the proximal first retention end positioned along the tray body, the distal first retention end being offset from the tray body and the first plane, the second retention portion extending towards the capturing recess from the distal first retention end; and a sheath shaped to extend along a length of the capturing recess and configured to encompass at least a portion of the fill needle of the needle assembly, at least a portion of the sheath configured to be releasably captured by the second retention portion and the tray body to assist with securing a position of the sheath relative to the capturing recess; and a securing mechanism coupled to the tray body and configured to releasably secure a tubing of the needle assembly to the tray body.

24. The needle and tubing organizing support kit of claim 23, wherein the securing mechanism comprises a cylindrical belt or a tubing.

25. The needle and tubing organizing support kit of claim 23, wherein the securing mechanism comprises a beaded cable or beaded tie.

26. The needle and tubing organizing support kit of claim 23, wherein the securing mechanism comprises a tubing connector.

27. The needle and tubing organizing support kit of claim 23, wherein the securing mechanism is a part of the tray body and configured to releasably secure a portion of the tubing to the tray body.

28. The needle and tubing organizing support kit of claim 23, wherein the securing mechanism comprises an opening, pinch point, slot, or hole along the tray body.

29. The needle and tubing organizing support kit of claim 23, wherein the fill needle comprises a length between approximately 2.5 inches to approximately 8 inches.

30. The needle and tubing organizing support kit of claim 23, wherein the tubing is formed of one or more of polyvinylchloride, polyethylene, or polypropylene.

31. The needle and tubing organizing support kit of claim 23, wherein the sheath comprises an elongated pocket configured to encompass at least a portion of the needle.

32. The needle and tubing organizing support kit of claim 31, wherein the pocket comprises an opening at a proximal end of the sheath that is configured to receive at least the portion of the needle.

33. The needle and tubing organizing support kit of claim 23, wherein the sheath is formed out of a first sheath material and / or a second sheath material, the second sheath material being more flexible than the first sheath material.

34. The needle and tubing organizing support kit of claim 33, wherein at least a portion of the sheath, when formed of the first sheath material, is required to slide approximately parallel to and between the tray body and the second retention portion to releasably couple the sheath to the tray body.

35. The needle and tubing organizing support kit of claim 33, wherein at least a portion of the sheath, when formed of the second sheath material, is configured to deform to releasably couple the sheath to the tray body and / or is configured to slide approximately parallel to and between the tray body and the second retention portion to releasably couple the sheath to the tray body.

36. The needle and tubing organizing support kit of claim 23, wherein the retention element is located adjacent to the capturing recess.

37. The needle and tubing organizing support kit of claim 23, wherein the tray assembly comprises more than one retention element, the more than one retention element located along more than one side of the capturing recess.

38. The needle and tubing organizing support kit of claim 23, wherein the capturing recess is a groove, channel, depression, or indentation.

39. The needle and tubing organizing support kit of claim 23, wherein the capturing recess has a curved and / or U-shaped cross- section.

40. The needle and tubing organizing support kit of claim 23, wherein the retention element and tray body define a sheath receiving slot therebetween.

41. The needle and tubing organizing support kit of claim 23, wherein the sheath receiving slot is configured to receive at least a portion of the sheath.

42. The needle and tubing organizing support kit of claim 23, wherein the sheath is formed out of one or more of a polyester, polyethylene, polypropylene, polymethyl methacrylate, and an elastomer.

43. The needle and tubing organizing support kit of claim 23, wherein the sheath is formed of a layered film and includes a side seam along at least a portion of each opposing sides of the sheath and an end seam along at least a portion of the end of the sheath.

44. The needle and tubing organizing support kit of claim 43, wherein the end seam is offset from a distal end of the sheath to form a protective gap between the end seam and the distal end of the sheath, the protective gap configured to assist with protecting at least a distal end of the fill needle when the needle assembly is coupled to the needle and tubing organizing support system.

45. The needle and tubing organizing support kit of claim 23, wherein the tray assembly further comprises a mounting element that is configured to assist with mounting the needle and tubing organizing support system to a fixture.

46. The needle and tubing organizing support kit of claim 45, wherein the mounting element comprises a hole through the tray body.

47. A tray assembly configured to protect and retain a portion of a needle assembly, the tray assembly comprising: a tray body, at least a portion of the tray body extending along a first plane; a capturing recess extending along the tray body and forming an opening along the tray body, the capturing recess comprising a capturing wall spanning across the opening andprotruding away from the tray body and the first plane, wherein the capturing recess is configured to at least partially contain a needle of the needle assembly; and a retention element configured to assist with securing a needle of the needle assembly within at least a part of the capturing recess.

48. The tray assembly of claim 47, wherein the retention element forms a sheath receiving slot configured to receive a part of a sheath.

49. The tray assembly of claim 47, wherein the retention element comprises a clip.

50. The tray assembly of claim 47, wherein the retention element comprises a first retention portion and a second retention portion, the first retention portion extending between a proximal first retention end and a distal first retention end, the proximal first retention end positioned along the tray body, the distal first retention end being offset from the tray body and the first plane, the second retention portion extending towards the capturing recess from the distal first retention end.

51. The tray assembly of claim 47, further comprising: a sheath shaped to extend along a length of the capturing recess and configured to encompass at least a portion of the needle of the needle assembly, at least a portion of the sheath configured to be releasably captured by the second retention portion and the tray body to assist with securing a position of the sheath relative to the capturing recess.

52. The tray assembly of claim 51, wherein the sheath comprises an elongated pocket configured to encompass at least a portion of the needle.

53. The tray assembly of claim 52, wherein the pocket comprises an opening at a proximal end of the sheath that is configured to receive at least the portion of the needle.

54. The tray assembly of claim 51, wherein the sheath is formed out of a first sheath material and / or a second sheath material, the second sheath material being more flexible than the first sheath material.

55. The tray assembly of claim 51, wherein at least a portion of the sheath, when formed of the first sheath material, is required to slide approximately parallel to and between the tray body and the second retention portion to releasably couple the sheath to the tray body.

56. The tray assembly of claim 51, wherein at least a portion of the sheath, when formed of the second sheath material, is configured to deform to releasably couple the sheath to the tray body and / or is configured to slide approximately parallel to and between the tray body and the second retention portion to releasably couple the sheath to the tray body.

57. The tray assembly of claim 47, wherein the retention element is located adjacent to the capturing recess.

58. The tray assembly of claim 47, wherein the tray assembly comprises more than one retention element, the more than one retention element located along more than one side of the capturing recess.

59. The tray assembly of claim 47, wherein the capturing recess is a groove, channel, depression, or indentation.

60. The tray assembly of claim 47, wherein the capturing recess has a curved and / or Ilshaped cross-section.

61. The tray assembly of claim 47, wherein the retention element and tray body define a sheath receiving slot therebetween.

62. The tray assembly of claim 61, wherein the sheath receiving slot is configured to receive at least a portion of the sheath.

63. The tray assembly of claim 51, wherein the sheath is formed out of one or more of a polyester, polyethylene, polypropylene, polymethyl methacrylate, and an elastomer.

64. The tray assembly of claim 51, wherein the sheath is formed of a layered film and includes a side seam along at least a portion of each opposing sides of the sheath and an end seam along at least a portion of the end of the sheath.

65. The tray assembly of claim 64, wherein the end seam is offset from a distal end of the sheath to form a protective gap between the end seam and the distal end of the sheath, the protective gap configured to assist with protecting at least a distal end of the fill needle when the needle assembly is coupled to the tray assembly.

66. The tray assembly of claim 47, further comprising: a securing mechanism configured to releasably secure a tubing of the needle assembly to the tray body.

67. The tray assembly of claim 66, wherein the securing mechanism comprises a cylindrical belt or tubing.

68. The tray assembly of claim 66, wherein the securing mechanism comprises a beaded cable or beaded tie.

69. The tray assembly of claim 66, wherein the securing mechanism comprises a tubing connector.

70. The tray assembly of claim 66, wherein the securing mechanism is integrated with the tray body and configured to releasably secure a tubing of the needle assembly to the tray body.

71. The tray assembly of claim 66, wherein the securing mechanism comprises an opening, pinch point, slot, or hole along the tray body.

72. The tray assembly of claim 47, wherein the tray assembly further comprises a mounting element that is configured to assist with mounting the tray assembly to a fixture.

73. The tray assembly of claim 72, wherein the mounting element comprises a hole through the tray body.

74. A method of a needle and tubing organizing support system, the method comprising: inserting a needle into a sheath; and coupling the sheath to a tray body of the needle and tubing organizing support system, the needle and tubing organizing support system comprising: a capturing recess extending along the tray body and forming an opening along the tray body, the capturing recess comprising a capturing wall spanning across the opening and protruding away from the tray body and the first plane, wherein the capturing recess is configured to at least partially contain a needle of the needle assembly; and a retention element comprising a first retention portion and a second retention portion, the first retention portion extending between a proximal first retention end and a distal first retention end, the proximal first retention end positioned along the tray body, the distal first retentionend being offset from the tray body and the first plane, the second retention portion extending towards the capturing recess from the distal first retention end, and wherein the sheath is shaped to extend along a length of the capturing recess and configured to encompass at least a portion of the needle of the needle assembly, at least a portion of the sheath configured to be releasably captured by the second retention portion and the tray body to assist with securing a position of the sheath relative to the capturing recess.

75. The method of claim 74, wherein the tray body further comprises a mounting hole or opening.

76. The method of claim 75, further comprising: securing the mounting hole or opening to a fixture to support the tray body in an upright orientation.

77. The method of claim 74, wherein the coupling comprises positioning a portion of the sheath between the tray body and the retention element.

78. The method of claim 74, further comprising: removing the sheath from between the tray body and the retention element.

79. The method of claim 74, wherein the needle and tubing organizing support system further comprises a securing mechanism coupled to the tray body and configured to releasably secure a tubing of the needle assembly to the tray body.

80. The method of claim 74, further comprising: securing the tubing to the tray body.

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