Apparatus and system for transporting medical equipment

JP2025503263A5Pending Publication Date: 2026-02-04BECTON DICKINSON FRANCE SAS
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Patent Information

Application Number
JP2024544976
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-01-28
Filing Date
2023-01-27
Publication Date
2026-02-04

AI Technical Summary

Technical Problem

During long-distance transportation of medical containers like pre-filled syringes, the holding devices rub against the package material, generating particles that contaminate the syringes, requiring cleaning before use.

Method used

A device with a plate and positioning elements that fit snugly within a package, minimizing contact and preventing particle generation by adjusting angles and flexibility to reduce friction.

Benefits of technology

Prevents contamination by reducing friction and particle generation, ensuring medical containers remain sterile and ready for use upon arrival.

✦ Generated by Eureka AI based on patent content.

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Abstract

The apparatus for supporting a plurality of medical containers comprises a plate having an upper surface, a lower surface, and a sidewall defining a perimeter of the plate and extending between the upper surface and the lower surface. The sidewall comprises four edges intersecting at corners. A longitudinal axis of the plate extends perpendicular to the upper surface. The plate defines a plurality of openings extending through the plate from the upper surface to the lower surface. Each opening is configured to hold a medical container therein. The plate is dimensioned to be disposed within a package for shipping a plurality of medical containers, such that a distance measured between opposing edges of the sidewalls is less than a distance measured between opposing sidewalls on an inner surface of the package. The apparatus further comprises at least two positioning elements coupled to the plate at a first end thereof. Each positioning element has a second end detached from the plate.
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Description

[Technical field]

[0001] SUMMARY The present disclosure relates generally to devices, commonly referred to in the art as nests, for carrying medical containers, such as syringes, and systems including such devices. [Background technology]

[0002] A medical container, such as a prefillable or pre-filled syringe, may be transported from one location to another. For example, the medical container may be transported from a location where it is manufactured to a location where the medical container is filled with a medicinal fluid. As a further example, the medical container may be manufactured and filled at the same location and then transported to a storage location in a sterile package. During transportation, the medical container is supported by a retaining device, which may be called a nest. The retaining device may be placed in a package with an opening that allows the retaining device to be placed therein and then sealed by a sealing cover. The container may be called a tub.

[0003] To facilitate assembly, the exterior dimensions of the retainer are slightly smaller than the interior dimensions of the package, making it easy for the retainer to move relative to the package during transportation. As a result of such movement during long-distance transportation, the retainer may rub against the inner surface of the package, wearing away the packaging material and / or the retainer material, generating particles of the packaging or retainer material. Because the package is sealed by a hermetic cover, the particles remain in the package throughout the remainder of the transportation and storage period. Such particles may become dispersed within the package and thus end up inside or on the medical container stored within the package. When the medical container arrives at its destination, it is intended that the medical container is ready for immediate use. As a non-limiting example, if the medical container is a pre-fillable syringe, the syringe is intended to be clean and sterile when it arrives at the filling location so that the syringe is filled with the medical fluid. If particles of the packaging material and / or the retainer material are dispersed within or on the syringe, the syringe is not ready for immediate use and must be cleaned prior to filling to avoid contamination of the medical fluid with which the medical container is filled. Thus, there is a need for a packaging solution that inhibits or completely prevents particle generation within the package. Summary of the Invention

[0004] It is an object of the present disclosure to provide an apparatus for supporting a plurality of medical containers that overcomes the above-mentioned problems. The apparatus includes a plate having an upper surface, a lower surface, and a sidewall, the sidewall defining a perimeter of the plate and extending between the upper surface and the lower surface. The sidewall includes four edges connected at corners. A longitudinal axis of the plate extends perpendicular to the upper surface. The plate defines a plurality of openings extending from the upper surface to the lower surface. Each opening is configured to hold a medical container therein. The plate is dimensioned to be placed in a package for shipping a plurality of medical containers, such that a distance measured between opposing edges of the sidewall is less than a distance measured between opposing sidewalls of an interior surface of the package. The apparatus further includes at least two positioning elements having first ends coupled to the plate. Each of the positioning elements has a second end opposite the first end and detached from the plate.

[0005] When the plate is placed in the package, each positioning element forms an acute angle with respect to the longitudinal axis of the plate and extends a lateral distance beyond the sidewall of the plate such that each of the positioning elements contacts the inner surface of the sidewall of the package when the plate is placed therein.

[0006] Typically, a first positioning element of the at least two positioning elements is disposed at least partially on a first edge of the four edges, and a second positioning element of the at least two positioning elements is disposed at least partially on a second edge of the four edges, the first edge and the second edge being adjacent to one another.

[0007] In one embodiment, a first of the at least two positioning elements is disposed on only a first of the four edges, and a second of the at least two positioning elements is disposed on only a second of the four edges, the first edge and the second edge being adjacent to each other.

[0008] In another embodiment, a first of the at least two positioning elements is arranged at a first corner and a second of the at least two positioning elements is arranged at a second corner, the first corner and the second corner being diagonally opposite each other. In this embodiment, when the positioning element is arranged at a corner, it is arranged at the intersection of two adjacent edges, and therefore it is arranged partly on the first edge and partly on the second edge adjacent to the first edge.

[0009] Particular preferred but non-limiting features of the above-described device, individually or in combination, are the following:

[0010] the positioning element being a rigid element configured to be displaced such that an acute angle of the positioning element is variable by one degree between when a plate having the positioning element thereon is disposed within the package and when the plate is outside the package; the positioning element being a flexible element configured to be displaced such that an acute angle of the positioning element varies between 65 degrees and 80 degrees between when a plate having the positioning element thereon is disposed within the package and when the plate is outside the package; the positioning element is integrally formed with the plate; At least one positioning element is coupled to each edge of the sidewall; and / or The apparatus includes four positioning elements, one positioning element coupled to each corner of the sidewall.

[0011] Another object of the present disclosure is to provide a packaging system for receiving a plurality of medical containers, the packaging system including a package with side walls extending from a bottom wall, the inner surface of the side walls being stepped to define a shelf. The packaging system also includes an apparatus including a plate having at least two positioning elements as described above disposed within the package. The lower surface of the plate is disposed on the shelf, and the positioning elements are disposed on the inner surface of the side walls.

[0012] Particular preferred but non-limiting features of the above-described device, individually or in combination, are the following:

[0013] a surface of the positioning element disposed on the inner surface of the side wall having bends at corners corresponding to the bends on the inner surfaces of the plurality of side walls; a lesser portion of the surface area of ​​the face of the positioning element is disposed against the inner surface of the sidewall; The axial dimension of each positioning element is less than or equal to the vertical dimension measured between the shelf and the top surface of the package; the plate including the positioning elements engages an inner surface of the side wall of the package with an interference fit; and / or The apparatus further comprises a plurality of chimneys, each extending circumferentially around an opening of the plurality of openings and extending axially above the upper surface of the plate, each chimney configured to hold a medical container therein. [Brief description of the drawings]

[0014] The figures presented herein are not intended to be actual diagrams of any particular components, devices, or systems, but are merely idealized representations used to describe embodiments of the invention. Other features, objects, and advantages of the invention will appear more clearly upon reading the following detailed description and upon reference to the drawings, which are provided as non-limiting examples. [Figure 1A] FIG. 1A is a top schematic view of an apparatus for supporting multiple medical containers. [Figure 1B] FIG. 1B is a top schematic view of an apparatus for supporting multiple medical containers. [Figure 1C] FIG. 1C is a top schematic view of an apparatus for supporting multiple medical containers. [Diagram 2] FIG. 2 is a partial cross-sectional view of the device of FIGS. 1A-1C relative to a package. [Diagram 3] FIG. 3 is a partial cross-sectional view of the device of FIGS. 1A-1C relative to a package. [Figure 4] FIG. 4 is a partial cross-sectional view of the device of FIGS. 1A-1C relative to a package. [Figure 5A] FIG. 5A is a top schematic view of another apparatus for supporting multiple medical containers. [Figure 5B] FIG. 5B is a top schematic view of another apparatus for supporting multiple medical containers. [Figure 6] FIG. 6 is a partial perspective view of the device of FIGS. 5A-5B. [Figure 7] FIG. 7 is a partial cross-sectional view of the device of FIGS. 5A-5B relative to a package. [Figure 8] FIG. 8 is a perspective view of the device of FIGS. 5A-5B disposed in a package. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] As used herein, the terms "first," "second," "top," "bottom," "upper," "lower," "upper," "lower," "on," "inner," "outer," and related terms are used for clarity and convenience in understanding the disclosure and the accompanying drawings, and do not imply or rely on any particular preference, orientation, or order unless clearly indicated by context.

[0016] As used herein, the terms "axial," "axially," "longitudinal," and "longitudinal" generally mean and refer to a direction along or parallel to the longitudinal axis of the plate and package elements described herein.

[0017] As used herein, the terms "lateral" and "laterally" generally mean and refer to a direction perpendicular to the central longitudinal axis of the element(s) of the plates and packages described herein.

[0018] As used herein, the term "about" in connection with a given parameter is inclusive of the stated value and has the meaning dictated by the context (e.g., includes the degree of error associated with measurement of the given parameter).

[0019] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0020] As used herein, the term "configured" refers to the size, shape, material composition, material distribution, orientation, and arrangement of one or more of at least one structure and at least one device to facilitate operation of one or more of the structures and devices in a predetermined manner.

[0021] 1A-1C show an apparatus 100 configured to support a plurality of medical containers therein. The apparatus 100 may be generally referred to in the art as a nest. The medical containers may be vials, syringes such as prefillable or prefilled syringes, or any medical element that may be transported within the nest, such as a stopper or syringe gasket. The medical containers are configured to contain a medical fluid therein after filling.

[0022] The apparatus 100 may include a plate 102 having an upper surface 104, a lower surface 106 (seen in FIG. 2), and a sidewall 108 extending between the upper surface 104 and the lower surface 106.

[0023] The sidewalls 108 define a perimeter portion of the plate 102. The sidewalls include four edges 107 connected at corners 109. The corners 109 may be rounded or sharp. The edges 107 may include flat surfaces. Such surfaces of opposing edges 107 may extend parallel to one another.

[0024] The longitudinal axis 101 of the plate 102 extends perpendicular (eg, perpendicular) to the upper surface 104 .

[0025] The plate 102 defines a number of openings 110 extending therethrough from the upper surface 104 to the lower surface 106. Each opening 110 is configured to allow a medical container to pass therethrough.

[0026] The plate 102 may also include a number of chimneys 130 projecting axially from the top surface 104. Each chimney 130 extends at least partially circumferentially around a corresponding opening 110. Each chimney 130 may be of generally cylindrical construction. Each chimney 130 defines an opening in which a medical container may be retained. Each chimney 130 may have a centrally extending longitudinal axis parallel to the longitudinal axis 101 of the plate 102. Each chimney 130 may be integrally formed with the plate 102.

[0027] The apparatus 100 includes at least two positioning elements 120. Each positioning element 120 extends between a first end 122 and a second end 124 opposite the first end 122. The first end 122 is coupled to the plate 102. The second end 124 is decoupled from the plate 102.

[0028] The first positioning element 120a is located (e.g., disposed) at least partially on the first edge 107. The second positioning element 120b is located at least partially on the second edge 107.

[0029] Typically, in the first embodiment, the first positioning element 120a may be exclusively (e.g., completely) disposed on the first edge 107. The second positioning element 120b may be exclusively disposed on the second edge 107 adjacent to the first edge 107. Figure 1A shows an embodiment including two positioning elements 120 in such a configuration.

[0030] In further embodiments, the device 100 may include four positioning elements 120, as shown in FIG. 1B. One positioning element 120 may be positioned on each edge 107. In some embodiments, the positioning elements 120 may be distributed such that the positioning elements 120 on opposing edges 107 are positioned directly opposite one another. In other words, when the device 100 includes four positioning elements 120, the positioning elements may each be positioned around the center of each of the four edges 107 of the device 100 (e.g., midway between the corners 109).

[0031] 1C, device 100 may include eight positioning elements 120. Two positioning elements 120 may be positioned on each edge 107. In some embodiments, positioning elements 120 may be distributed such that one positioning element 120 on a given edge 107 is diametrically opposed to another positioning element 120 on the diametrically opposite edge 107.

[0032] In each of the foregoing embodiments, the positioning elements 120 may be positioned exclusively at the edges 107 of the plate 102 such that the positioning elements 120 do not extend along the corners 109 .

[0033] As described with reference to Figures 1A-1C, positioning elements 120 on at least two adjacent edges 107 limit movement of device 100 in two directions perpendicular to longitudinal axis 101, including the x- and y-directions, as shown by the coordinate system of Figure 1B, when device 100 is placed in a package or tub and subjected to long-distance transportation.

[0034] The device 100 is dimensioned to be placed in a package configured to transport multiple medical containers. Figure 2 shows a partial view of a package 302 into which the device 100 can be placed. The device 100 and the package 302 collectively form a packaging assembly for transporting multiple medical containers.

[0035] The package 302 includes side walls 304 defining its periphery and extending from a bottom wall 306. The interior of the package 302 is hollow and defined by an inner surface of the bottom wall 306 and an inner surface 308 of the side walls 304.

[0036] The sidewall 304 may be stepped to define a shelf 310. The shelf 310 provides a horizontal surface configured to support the device 100. When the device 100 is placed within the package 302, the underside 106 of the device 100 rests on the shelf 310. The shelf 310 may extend continuously or discontinuously around the perimeter of the interior surface 308.

[0037] The flange may be provided at an end of the sidewall 304 opposite where the bottom wall 306 is located. The flange defines a top surface 312 of the sidewall 304. The flange may extend continuously around the periphery of the sidewall 304.

[0038] The flange further defines a perimeter of an opening 314 through which the device 100 can be placed within the package 302 .

[0039] At least a portion of the inner surface 308 of the sidewall 304 may be sloped. More specifically, the inner surface 308 of the sidewall 304 that extends between the shelf 310 and the top surface 312 may be sloped. The slope of the sidewall 304 is best seen in Figures 2 and 7.

[0040] As previously mentioned, device 100 is dimensioned to be placed within package 302 through opening 314. More specifically, plate 102 is dimensioned such that the distance measured between opposing edges 107 of sidewalls 108 (i.e., the lateral dimension, which is either the width or length of plate 102 excluding positioning element 120) is less than the distance measured between corresponding opposing interior surfaces 308 of sidewalls 304.

[0041] The positioning element 120 has an axis 121 that extends between a first end 122 and a second end 124. The axis 121 of the positioning element 120 forms an angle α with the longitudinal axis 101 of the plate 102.

[0042] The positioning element 120 may be a flexible element. As used herein, the term “flexible element” refers to a positioning element 120 that is movable by an angle α of up to 90 degrees relative to a first position when the device 100 is outside the package 302 and to a second position when the device 100 is inside the package 302. More specifically, the positioning element 120 is movable by 65 degrees to 80 degrees from the first position when the device 100 is outside the package 302 to the second position when the device is inside the package 302.

[0043] 2, prior to placing device 100 within package 302, angle α of positioning element 120 extends at 90 degrees relative to longitudinal axis 101. As device 100 is inserted through opening 314 toward shelf 310, angle α decreases as outer surface 126 of positioning element 120 engages inner surface 308 of sidewall 304.

[0044] When device 100 is positioned within package 302 such that underside 106 of plate 102 is disposed on the horizontal plane of shelf 310, as shown in Figures 3 and 4, angle α of positioning element 120 forms an acute angle with respect to longitudinal axis 101. Acute angle α may be in the range of 10 to 25 degrees, inclusive, and more preferably in the range of 15 to 20 degrees, inclusive.

[0045] The flexibility of positioning element 120 allows the lateral dimensions of device 100 to decrease as device 100 is placed within package 302. The flexibility of positioning element 120 also allows device 100 to be removed from package 302.

[0046] A given positioning element 120 projects axially (i.e., parallel to the longitudinal axis 101) beyond the top surface 104 and laterally (i.e., perpendicular to the longitudinal axis 101) beyond the sidewall 108. Thus, each positioning element 120 has an axial dimension D, which is measured as the positioning element 120 projects from the bottom surface 106 to a second end 124 of the positioning element 120. 122Aand a lateral dimension D measured such that the positioning element 120 protrudes from the edge 107 of the sidewall 108 where the first end 122 of the positioning element 120 is joined to the second end 124 of the positioning element 120. 122L and

[0047] Prior to placing the device 100 within the package 302, the lateral dimension D of at least one positioning element 120 is 122L And the lateral dimension of the plate 102, when combined, is greater than the lateral dimension of the package 302 (ie, the distance measured between the two opposing inner surfaces 308 of the side walls 304 excluding the positioning element 120).

[0048] When device 100 is placed within package 302 and on shelf 310, device 100 and package 302 are engaged by an interference fit.

[0049] In some embodiments, such as the embodiment of FIG. 1A , when the device 100 is placed in the package 302, a space may be located between the inner surface 308 of the sidewall 304 and at least two edges 107 and at least one corner 109 of the sidewall 108 of the plate 102. In other embodiments, such as the embodiment of FIG. 1B and FIG. 1C , when the device 100 is placed in the package 302, a space may be located between the inner surface 308 of the sidewall 304 and each edge 107 and corner 109 of the sidewall 108 of the plate 102. In such embodiments, there is no contact between the sidewall 304 and the sidewall 108.

[0050] When device 100 is placed within package 302 , a lesser portion of the surface area of ​​outer surface 126 of positioning element 120 contacts inner surface 308 of sidewall 304 .

[0051] The exterior surface 126 may be planar if the positioning element 120 extends along the edge 107. The planar exterior surface 126 corresponds to the plane of the sidewall 304 of the package 302 that the positioning element 120 contacts.

[0052] The engagement of the positioning elements 120 with the inner surface 308 of the packaging 302, and optionally, in embodiments without the positioning elements 120 on each edge 107, with the side walls 108 of the plate 102 and the inner surface 308 of the packaging 302, prevents the device 100 from moving in a direction perpendicular to the longitudinal axis 101 of the plate 102. By preventing lateral movement between the device 100 and the package 302, the device 100 and the package 302 do not rub against each other and generate particles of the packaging material and / or device material.

[0053] The interference fit between the device 100 and the package 302 also prevents or limits movement of the device 100 along the Z direction via friction with the package 302. Preferably, both lateral and vertical movement between the device 100 and the package 302 is avoided.

[0054] 5A and 5B show an apparatus 200 configured to support multiple medical containers therein.

[0055] The apparatus 200 includes a plate 102 having an upper surface 104, a lower surface 106, and a sidewall 108 extending between the upper surface 104 and the lower surface 106, as previously described herein.

[0056] The apparatus 200 includes at least two positioning elements 220. As shown in Figure 6, each positioning element 220 can extend between a first end 222 and a second end 224 opposite the first end 222. The first end 222 is coupled to the plate 102. The second end 224 is decoupled from the plate 102.

[0057] The first positioning element 220a may be located at a first corner 109. The second positioning element 220b may be located at a second corner 109 that is diagonally opposite the first corner 109. Figure 5A shows an embodiment including two positioning elements 220. When the positioning element 220 is located at a corner 109 of the device 200, the positioning element is partially located on two adjacent edges 107.

[0058] In a further embodiment, the device 200 can include four positioning elements 220, as shown in Figure 5B. One positioning element 220 can be positioned at each corner 109.

[0059] The positions of at least two positioning elements 220 at diagonally opposed corners 109 limit movement of device 200 in directions perpendicular to longitudinal axis 101, including the x and y directions, as shown by the coordinate system of FIG. 5A, when device 200 is placed within package 302.

[0060] Each positioning element 220 has an axis 221 extending between a first end 222 and a second end 224. The axis 2211 of the positioning element 220 forms an angle α with respect to the longitudinal axis 101 of the plate 102.

[0061] The positioning element 220 can be a rigid element. As used herein, the term “rigid element” refers to a positioning element 220 that is movable through an angle β of up to 5 degrees, and more specifically, 1 degree between a first position when the device 200 is outside the package 302 and a second position when the device 200 is inside the package 302.

[0062] Prior to placing the device 200 within the package 302, the angle β of the positioning element 220 is approximately 5 degrees greater than the angle of the sloping sidewall 304 of the inner surface 308 of the package 302 (e.g., the angle measured between a line tangent to the inner surface 308 of the sidewall 304 and the longitudinal axis 101). In some embodiments, the angle β of the positioning element 220 is in the range of 31 degrees to 46 degrees, and more preferably in the range of 36 degrees to 41 degrees, relative to the longitudinal axis 101. As the device 200 is inserted through the opening 314 toward the shelf 310, the angle β decreases as the outer surface 226 of the positioning element 220 engages the inner surface 308 of the sidewall 304.

[0063] When the device 200 is placed in the package 302 such that the lower surface 106 of the plate 102 is disposed on the horizontal plane of the shelf 310, the angle β of the positioning element 220 forms an acute angle with respect to the vertical axis 101. This acute angle β is approximately 4 degrees greater than the angle between the inner surface 308 of the side wall 304 and the vertical axis 101. Thus, the acute angle β may be in the range of 30 degrees to 45 degrees, and more preferably in the range of 35 degrees to 40 degrees, with respect to the vertical axis 101, as shown in FIG. 7. Thus, the acute angle β may be in the range of 30 degrees to 45 degrees, and more preferably in the range of 35 degrees to 40 degrees, with respect to the vertical axis 101, as shown in FIG.

[0064] The flexibility of positioning element 220 allows the lateral dimensions of device 200 to decrease as device 200 is placed within package 302. The flexibility of positioning element 220 also allows device 200 to be removed from package 302.

[0065] As described for device 100, plate 102 is dimensioned such that the distance measured between opposing edges 107 of sidewalls 108 (i.e., the lateral dimension, which is either the width or length of plate 102 excluding positioning elements 120) is less than the distance measured between corresponding opposing interior surfaces 308 of sidewalls 304. Plate 102 is also dimensioned such that the distance measured between opposing corners 109 of sidewalls 108 (i.e., the diagonal lateral dimension of plate 102) is less than the distance measured between diagonally opposed corners 316 of packages 302.

[0066] A given positioning element 220 protrudes axially beyond the top surface 104. The positioning element 220 protrudes laterally beyond the sidewall 108, and more specifically, beyond the corner 109. The positioning element 220 has an axial dimension D, which is measured such that the positioning element 220 protrudes between the bottom surface 106 and the second end 224 of the positioning element 220. 222A and a lateral dimension D measured so that the first end 222 of the positioning element 220 projects between the corner 109 of the sidewall 108 to which it is joined and the second end 224 of the positioning element 220.222L and

[0067] Axial dimension D 222A is the vertical dimension D measured between the horizontal surface of the shelf 310 and the top surface 312 of the side wall 304 304 The vertical dimension D is as follows: 304 is measured in a direction perpendicular to the inner surface of the bottom wall 306.

[0068] Axial dimension D 222A is the axial dimension D 304 , the second end 224 of the positioning element 220 is positioned against (e.g., in contact with) the sealing element 330, as described in more detail below. The engagement of the positioning element 220 with the sealing element 330 prevents the device 200 from moving in a direction parallel to the longitudinal axis 101 of the plate 102. Because axial movement between the device 200 and the package 302 is prevented, the device 200 and the package 302 do not rub against each other in a manner that would generate particles of the packaging material and / or device material.

[0069] Lateral dimension D of positioning element 220 222L and the diagonal dimensions of the plate 102, when added together, are greater than the lateral dimension of the package 302 (ie, the distance measured between two opposing corners 316 of the inner surface 308 of the side wall 304).

[0070] When device 200 is placed within package 302 and on shelf 310, device 200 and package 302 engage with an interference fit.

[0071] Device 200 and package 302 collectively form a packaging assembly 300 for shipping multiple medical containers, as shown in FIG.

[0072] When device 200 without a positioning element according to the present invention is placed within package 302, spaces may be located between the inner surface 308 of sidewall 304 and each edge 107 and corner 109 of sidewall 108 of plate 102. In such an embodiment, there will be insufficient contact between sidewall 304 and sidewall 108, causing device 200 to move within package 302.

[0073] When device 200 including positioning elements 220 is placed within package 302, positioning elements 220 may abut inner surfaces 308 of sidewalls 304. More specifically, outer surfaces 226 of each positioning element 220 may abut inner surfaces 308 of sidewalls 304.

[0074] A lesser portion of the surface area of ​​the exterior surface 226 is disposed against the interior surface 308 of the sidewall 304 .

[0075] The outer surface 226 can be curved as the positioning element 220 extends around the corner 109. The radius of curvature of the outer surface 226 of the positioning element 220 can be substantially equal to the radius of curvature of the corner 316 of the sidewall 304 of the package 302. The curvature of the positioning element 220 can be seen in the top views of Figures 5A and 5B.

[0076] Engagement of the positioning element 220 with the package 302 can prevent the device 200 from moving in a direction perpendicular to the longitudinal axis 101 of the plate 102. Preventing lateral movement between the device 200 and the package 302 can prevent the device 200 and the package 302 from rubbing against each other and generating particles of the packaging material and / or the device material.

[0077] A sealing element 330 (FIGS. 3 and 7) can be bonded to the top surface 312. The sealing element 330 is configured to close the opening 314 of the package 302 after the device 100, 200 is placed therein and to allow sterilization of the package 302. The sealing element 330 is a barrier to microorganisms. The sealing element 330 can be a porous microbial barrier. The sealing element 330 can also be permeable to a sterilizing gas such that the interior of the package 302 can be sterilized after the sealing element 330 is placed on the top surface 3126. The sterilizing gas can be, for example, ethylene oxide. In an exemplary embodiment, the sealing element 330 can be formed of a Tyvek® sheet.

[0078] In some embodiments, the second end 224 of the positioning element 220 has a rounded surface 228. The rounded surface 228 is configured to contact the sealing element 330 without penetrating the sealing element 330 during transportation of the assembly 300.

[0079] In any of the above-described embodiments, the positioning element 120, 220 may be integrally formed with the plate 102. In such embodiments, the positioning element 120, 220 and the plate 102 are formed together in a one-shot or two-shot injection molding process. Alternatively, the positioning element 120 may be formed separately from the plate 102 and bonded to the plate 102 by an adhesive or other bonding means. The positioning element 120, 220 may be formed of the same or a different polymeric material as the plate 102.

[0080] While the present disclosure is described herein with respect to certain illustrated embodiments, those skilled in the art will recognize and understand that it is not limited thereto. Rather, many additions, deletions, and modifications to the illustrated embodiments may be made without departing from the scope of the present disclosure, including legal equivalents. In addition, features of one embodiment may be combined with features of other embodiments as contemplated by the inventors while still falling within the scope of the present invention.

Claims

1. 1. An apparatus (100, 200) for supporting a plurality of medical containers, comprising: A plate (102) having an upper surface (104), a lower surface (106), and sidewalls (108) defining a periphery of the plate (102) and extending between the upper surface (104) and the lower surface (106), the sidewalls (108) including four edges (107) intersecting at corners (109), the longitudinal axis (101) of the plate (102) extending perpendicular to the upper surface (104), the plate (102) having multiple ribs (106) extending through the plate (102) from the upper surface (104) to the lower surface (106). a plate (102) defining a number of openings (110), each configured to hold a medical container therein, the plate (102) being dimensioned to be disposed in a package (302) for shipping a plurality of medical containers such that a distance measured between opposing edges (107) of the side walls (108) is less than a distance measured between opposing side walls (304) of an interior surface (308) of the package (302); at least two positioning elements (120, 220) coupled to the plate (102) at first ends (122, 222), each of the positioning elements (120, 220) having a second end (124, 224) opposite the first end (122, 222) that is detached from the plate (102), a first positioning element of the at least two positioning elements (120, 220) being at least partially disposed on a first edge of the four edges (107), and a second positioning element of the at least two positioning elements (120, 220) being at least partially disposed on a second edge of the four edges (107), the first edge and the second edge being adjacent to each other; Equipped with When the plate (102) is placed in the package (302), each of the positioning elements (120, 220) extends laterally beyond the side wall (108) of the plate (102) and axially beyond the top surface (104) of the plate (102), whereby each of the positioning elements (120, 220) forms an acute angle with the longitudinal axis (101) of the plate (102), and each of the positioning elements (120, 220) contacts the inner surface (308) of the side wall (304) of the package (302).

2. 2. The apparatus (200) of claim 1, wherein the first positioning element of the at least two positioning elements is positioned at a first corner (109), and the second positioning element of the at least two positioning elements is positioned at a second corner (109), and the first corner and the second corner (109) are diagonally opposite each other.

3. 3. The device (200) of claim 2, wherein each of the at least two positioning elements (220) is a rigid element configured to be displaced such that the acute angle (β) of the positioning element (220) is variable by approximately 1 degree between when the plate (102) having the positioning element (220) is disposed within the package (302) and when the plate (102) is outside the package (302).

4. 3. The apparatus (200) of claim 2, wherein the apparatus comprises four positioning elements, one positioning element (220) coupled to each corner (109) of the sidewall (108).

5. 2. The apparatus (100) of claim 1, wherein the first positioning element of the at least two positioning elements is disposed only on a first edge of the four edges (107), the second positioning element of the at least two positioning elements is disposed on a second edge of the four edges, the first edge and the second edge are adjacent to each other, and the first positioning element is spaced apart from the second positioning element.

6. 6. The apparatus (100) of claim 5, wherein the positioning element (120) is a flexible element configured to be displaced such that the acute angle (α) of the positioning element (120) is variable between 65 degrees and 80 degrees between when the plate (102) having the positioning element (120) is disposed within the package (302) and when the plate (102) is outside the package (302).

7. The apparatus (100) of claim 5, wherein at least one positioning element (120) is coupled to each edge (107) of the sidewall (108).

8. The apparatus (100, 200) of claim 1, wherein the positioning element (120, 220) is integrally formed with the plate (102).

9. A packaging system (300) for receiving a plurality of medical containers, comprising: a package (302) including a sidewall (304) extending from a bottom wall (306), the inner surface (308) of the sidewall (304) being stepped to define a shelf (310); 9. The apparatus (100, 200) according to any one of claims 1 to 8, comprising the plate (102) having the at least two positioning elements (120, 220) disposed on the package (302), wherein the lower surface (106) of the plate (102) is disposed on the shelf (310) and the positioning elements (120, 220) are disposed on the inner surface (308) of the side wall (304); A packaging system (300) comprising:

10. 10. The packaging system (300) of claim 9, wherein the surface (226) of each of the at least two positioning elements (220) arranged on the inner surface (308) of the side wall (304) has a curvature of a corner (316) corresponding to the curvature of the inner surface (308) of the plurality of side walls (304).

11. 10. The packaging system (300) of claim 9, wherein a lesser portion of the surface area of ​​the face (126, 226) of the positioning element (120, 220) is disposed against the inner surface (308) of the sidewall (304).

12. 10. The packaging system (300) of claim 9, wherein the axial dimension of each positioning element (220) is equal to or less than the axial dimension measured between the shelf (310) and the top surface (312) of the package (302).

13. 10. The packaging system (300) of claim 9, wherein the plate (102) including the positioning element (120, 220) engages the inner surface (308) of the side wall (304) of the package (302) with an interference fit.

14. 10. The packaging system of claim 9, wherein the device further comprises a plurality of chimneys, each chimney extending circumferentially around an opening of the plurality of openings and axially above the upper surface of the plate, each chimney configured to hold a medical container therein.