Holding device for medical containers with plates of different heights - Patents.com

Abstract

The retaining device configured to support the medical container includes a support plate having a first surface, a second surface, a peripheral edge between the first and second surfaces, and a plurality of openings through the support plate configured to receive the medical container. The surface of the support plate includes a peripheral lower portion extending inwardly from the peripheral edge, at least one upper portion surrounded by the peripheral lower portion, and at least one upwardly angled portion extending between the lower and upper portions. The retaining device further includes a plurality of chimneys protruding from the first and / or second surface of the support plate at least partially surrounding the plurality of openings, the plurality of chimneys adapted to guide insertion of the medical container into the plurality of openings.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to European Application No. 22305202.8, filed February 23, 2022, entitled "Holding Device for Medical Containers with Plates of Different Heights", the entire disclosure of which is incorporated herein by reference. [Background technology]

[0002] FIELD OF THEINVENTION The present disclosure relates generally to a holding device for holding medical containers, such as cartridges, barrels, prefilled syringes, stoppers, and / or prefillable syringes, in an upright position, and more particularly to a holding device that includes a support structure, such as a plate or tray, configured to be attached to a receptacle or tub for receiving the medical containers.

[0003] 2. Description of Related Art Medical containers, such as cartridges, barrels, prefilled syringes, stoppers, and / or prefillable syringes, often need to be transported from one site to another site during or after manufacturing. For example, the medical containers are manufactured at a first site and then transported to a second site where the medical containers are filled with a medical fluid. As used herein, "medical fluid" can refer to a drug or another therapeutic agent used to treat a chronic or acute condition, as known in the art. Exemplary therapeutic agents can include, for example, drugs, chemicals, biological substances, or biochemical substances that provide a desired therapeutic effect when administered to a patient in a therapeutically effective amount. In another example, the medical containers can be manufactured and filled at the same first site and then transported to a second site for storage.

[0004] During transportation, the medical containers can be held by a holding device such as a tray, a plate, and / or a nest. The nest can be a plate-like tray configured to support a plurality of medical containers in an upright position. The nest can be composed of a plurality of through holes or openings aligned according to a predetermined row, each through hole configured to receive one medical container. When inserted into the through holes, the medical containers are held in an upright position in a direction substantially perpendicular to the nest. The nest is usually placed inside an open-topped box-shaped vessel, which can be sealed with a sealing cover. Removal of the medical container from this vessel requires peeling off the sealing cover and removing the nest holding the medical container from the vessel by sliding the medical container axially relative to the nest. Exemplary nests and vessels configured to accommodate medical containers are disclosed, for example, in U.S. Pat. No. 10,023,358 (the "'358 patent"), entitled "Packaging for Containers," U.S. Pat. No. 10,143,793 (the "'793 patent"), entitled "Tray for Positioning Elongated Objects, Particularly Syringe Bodies or Syringes," and in U.S. Patent Application Publication No. 2021 / 0236715 A1 (hereinafter, the "'715 Publication"), entitled "Holding Device Configured to Support a Plurality of Medical Containers, Such as Syringes," each of which is incorporated by reference in its entirety.

[0005] Often, the medical containers are filled with medical fluids using an automated filler before the medical containers are removed from the nests and individually packaged. The nests may deform during filling due to forces exerted by the automated filler on the medical containers and / or nests. For example, when handled by the filler, the nests may bend or warp due to the weight of the multiple medical containers held by the nests. As a result of the deformation of the nests or trays, the medical containers supported by the deformed trays may not be held in an upright orientation, which may result in some inaccuracies during the filling and / or stoppering process. The deformation of the nests or trays may also cause problems when transporting the filled nests or trays to different locations.

[0006] For these reasons, there is a need for nest and tray designs with increased stiffness to reduce deflection of the nest or tray during transport and filling. Avoiding deformation can improve the accuracy of the filling process by avoiding misalignment between the medical containers housed by the tray or nest and the automated filler. The retention device of the present disclosure is intended to provide such increased stiffness to resist deflection or deformation under the weight of multiple medical containers housed by the tray or nest. Summary of the Invention

[0007] According to one aspect of the disclosure, a retaining device configured to support a medical container includes a support plate having a first surface, a second surface, a peripheral edge between the first and second surfaces, and a plurality of openings configured to receive the medical container through the support plate. The surface of the support plate includes a peripheral lower portion extending inwardly from the peripheral edge, at least one upper portion surrounded by the peripheral lower portion, and at least one upwardly angled portion extending between the lower and upper portions. The retaining device further includes a plurality of chimneys protruding from the first and / or second surfaces of the support plate at least partially surrounding the plurality of openings, such that the plurality of chimneys guide insertion of the medical container into the plurality of openings.

[0008] According to another aspect of the present disclosure, an assembly configured to support a plurality of medical containers includes a tub and the aforementioned retention device housed within the tub.

[0009] According to another aspect of the present disclosure, a method of manufacturing the aforementioned retention device includes injection molding or three dimensional printing the support plate and multiple chimneys of the retention device as a single piece via a single injection molding or three dimensional printing process.

[0010] Non-limiting illustrative examples of embodiments of the present disclosure are now described in the following numbered sections:

[0011] Clause 1: A retaining device configured to support a medical container, comprising: a support plate having a first surface, a second surface, a peripheral edge between the first and second surfaces, and a plurality of openings configured to receive the medical container through the support plate, wherein the surface of the support plate comprises a peripheral lower portion extending inwardly from the peripheral edge, at least one upper portion surrounded by the peripheral lower portion, and at least one upwardly angled portion extending between the lower portion and the upper portion, and a plurality of chimneys protruding from the first and / or second surface of the support plate at least partially surrounding the plurality of openings, wherein the plurality of chimneys are adapted to guide insertion of the medical container into the plurality of openings.

[0012] Clause 2: The retention device of clause 1, wherein the plurality of openings are arranged on the support plate as a plurality of rows and a plurality of columns.

[0013] Clause 3: The retention device of clause 2, wherein the openings in at least one of the plurality of rows and the openings in at least one of the plurality of columns are equidistantly spaced.

[0014] Clause 4: The retaining device of clause 2 or clause 3, wherein the plurality of openings are arranged on the support plate in at least five columns and at least five rows.

[0015] Clause 5: The retaining device of any of clauses 2-4, wherein the openings of adjacent columns are aligned parallel to a transverse axis of the support plate and the openings of adjacent rows are aligned parallel to a longitudinal axis of the support plate perpendicular to the transverse axis.

[0016] Clause 6: The retaining device of any of clauses 2 to 5, wherein the support plate has more columns than rows.

[0017] Clause 7: A holding device according to any one of clauses 1 to 6, in which the deflection of the support plate in the vertical direction is less than 2.5 mm when the medical container is fully filled.

[0018] Clause 8: The retention device of any of clauses 1 to 7, wherein the support plate and the plurality of chimneys are made from a thermoplastic polymer, such as polypropylene.

[0019] Clause 9: The retaining device of any of clauses 1 to 8, wherein the support plate has a substantially constant thickness.

[0020] Clause 10: A retaining device according to any one of clauses 1 to 9, wherein the support plate and the plurality of chimney-shaped portions are integrally formed, such as by injection molding or three-dimensional printing.

[0021] Clause 11: A retaining device according to any one of clauses 1 to 10, wherein the support plate has less than 100 openings.

[0022] Clause 12: A retaining device according to any one of clauses 1 to 11, wherein the support plate has less than 50 openings.

[0023] Clause 13: The retaining device of any of clauses 1 to 12, wherein the peripheral lower portion intersects at least an outer chimney of the plurality of chimneys.

[0024] Clause 14: A retaining device according to any of clauses 1 to 13, wherein a peripheral lower portion of the surface is flat.

[0025] Clause 15: A retaining device according to any of clauses 1 to 14, wherein an upper portion of the surface is flat.

[0026] Clause 16: The retaining device of any of clauses 1 to 15, wherein the upper portion is elevated relative to the lower portion by a vertical distance of about 2.0 mm to about 14.5 mm.

[0027] Clause 17: The retaining device of any of clauses 1 to 16, wherein at least one upper portion intersects with at least one of the plurality of chimney-shaped portions.

[0028] Clause 18: The retaining device of any of clauses 1 to 17, wherein at least one upper portion of the surface is a convex or concave surface.

[0029] Clause 19: The retaining device of any of clauses 1 to 18, wherein the angled portion intersects with at least one of the plurality of chimney portions.

[0030] Clause 20: The retaining device of any of clauses 1-19, wherein the angled portion is substantially vertical extending substantially perpendicularly from the lower portion.

[0031] Clause 21: The retention device of clause 20, wherein the vertical angle portion has a draft angle of about 0.1 degrees to about 4.0 degrees.

[0032] Clause 22: The retaining device of any of clauses 1 to 21, wherein the vertical angle portion intersects at least two adjacent chimneys of the plurality of chimneys.

[0033] Clause 23: A retaining device of any of clauses 1 to 22, wherein the angular portions alternate between inward angle segments angled toward a center of the first and / or second surface of the support plate and outward angle segments angled away from the center of the first and / or second surface of the support plate.

[0034] Clause 24: The retention device of any of clauses 1-23, wherein the peripheral edge includes at least one notch extending inwardly from another portion of the peripheral edge.

[0035] Clause 25: The retaining device of clause 24, wherein the at least one notch comprises a first notch on a first side of the support plate and a second notch on a second side of the support plate opposite the first side, the first and second notches being aligned along a first axis of the support plate.

[0036] Clause 26: The retaining device of clause 24 or clause 25, further comprising a curved wall extending from the first surface and / or the second surface around at least a portion of the at least one cutout.

[0037] Clause 27: A retaining device according to any of clauses 1 to 26, wherein the plurality of chimneys comprises a tubular wall having a cylindrical inner surface having a diameter substantially the same as the diameter of the opening surrounded by the chimneys, and a cylindrical outer surface opposite the inner surface.

[0038] Clause 28: The retaining device of clause 27, wherein the plurality of chimneys further comprises at least two axial slits separating the tubular wall into at least two guide tabs.

[0039] Clause 29: The holding device of any of clauses 1 to 28, wherein the plurality of openings and the plurality of chimneys are configured to receive a barrel of a syringe or cartridge containing a fluid volume of less than 50 mL.

[0040] Clause 30: A retaining device of any of clauses 1 to 29, wherein the surface of the support plate further comprises a second lower portion at least partially surrounded by the upper portion, and a downwardly angled portion extending between the upper portion and the second lower portion.

[0041] Clause 31: The retention device of clause 30, wherein the second lower portion and the downward angle portion each intersect with at least one chimney of the plurality of chimneys.

[0042] Clause 32: The retaining device of any of clauses 1-31, wherein the at least one upper portion comprises a first upper portion and a second upper portion separated from the first upper portion by a lower portion.

[0043] Clause 33: The retention device of clause 32, wherein the first upper portion and the second upper portion each intersect with at least one of the plurality of chimneys.

[0044] Clause 34: The retaining device of clause 33, wherein the surface of the support plate further comprises a second upper portion at least partially surrounded by a second lower portion, and a second upwardly angled surface extending between the second lower portion and the second upper portion.

[0045] Clause 35: An assembly configured to support a plurality of medical containers, the assembly comprising a vessel and a retaining device of any of clauses 1 to 34 housed within the vessel.

[0046] Clause 36: A method of manufacturing a retaining device of any of clauses 1 to 34, the method comprising injection molding or three-dimensional printing a support plate and a plurality of chimney-shaped portions by a single injection molding or three-dimensional printing process. [Brief description of the drawings]

[0047] [Figure 1A] FIG. 1A is a top surface perspective view of a retaining device configured to support a medical container according to one embodiment of the present disclosure. [Figure 1B] FIG. 1B is a top surface view of the tray of FIG. 1A. [Figure 1C] FIG. 1C is a cross-sectional view of the tray of FIG. 1A. [Figure 2A] FIG. 2A is a top surface perspective view of another example of a retaining device configured to support a medical container, according to an embodiment of the present disclosure. [Figure 2B] FIG. 2B is a bottom perspective view of the retaining device of FIG. 2A. [Figure 2C] FIG. 2C is a top surface view of the retainer of FIG. 2A. [Figure 2D] FIG. 2D is a cross-sectional view of the tray of FIG. 2A. [Figure 3A] FIG. 3A is a top surface view of another example of a retaining device configured to support a medical container, according to an embodiment of the present disclosure. [Figure 3B] FIG. 3B is a cross-sectional view of the tray of FIG. 3A. [Figure 4A] FIG. 4A is a perspective view of another example of a retaining device configured to support a medical container, according to an embodiment of the present disclosure. [Figure 4B] FIG. 4B is a top surface view of the tray of FIG. 4A. [Figure 5A]FIG. 5A is a schematic diagram illustrating a top surface view of an additional example of a retaining device configured to support a medical container, according to an embodiment of the present disclosure, where the cross-hatching represents a raised or elevated surface of the retaining device. [Figure 5B] FIG. 5B is a schematic diagram illustrating a top surface view of an additional example of a retaining device configured to support a medical container, according to an embodiment of the present disclosure, where the cross-hatching represents a raised or elevated surface of the retaining device. [Figure 5C] FIG. 5C is a schematic diagram illustrating a top surface view of an additional example of a retaining device configured to support a medical container, according to an embodiment of the present disclosure, where the cross-hatching represents a raised or elevated surface of the retaining device. [Figure 5D] FIG. 5D is a schematic diagram illustrating a top surface view of an additional example of a retaining device configured to support a medical container, according to an embodiment of the present disclosure, where the cross-hatching represents raised or elevated surfaces of the retaining device. [Figure 5E] FIG. 5E is a schematic diagram illustrating a top surface view of an additional example of a retaining device configured to support a medical container, according to an embodiment of the present disclosure, where the cross-hatching represents a raised or elevated surface of the retaining device. [Figure 5F] FIG. 5F is a schematic diagram illustrating a top surface view of an additional example of a retaining device configured to support a medical container, according to an embodiment of the present disclosure, where the cross-hatching represents a raised or elevated surface of the retaining device. [Figure 5G] FIG. 5G is a schematic diagram illustrating a top surface view of an additional example of a retaining device configured to support a medical container, according to an embodiment of the present disclosure, where the cross-hatching represents raised or elevated surfaces of the retaining device. [Figure 6A] FIG. 6A is a schematic diagram illustrating a top surface view of an additional example of a holding device configured to support a medical container, including segmented vertical walls and cross-hatching representing raised or elevated surfaces, in accordance with an embodiment of the present disclosure. [Figure 6B]FIG. 6B is a schematic diagram showing a top surface view of an additional example of a holding device configured to support a medical container, including segmented vertical walls and cross-hatching representing raised or elevated surfaces, in accordance with an embodiment of the present disclosure. [Figure 6C] FIG. 6C is a schematic diagram illustrating a top surface view of an additional example of a holding device configured to support a medical container, including segmented vertical walls and cross-hatching representing raised or elevated surfaces, in accordance with an embodiment of the present disclosure. [Figure 7A] FIG. 7A is a cross-sectional view of an additional example of a retaining device configured to support a medical container, according to an embodiment of the present disclosure. [Figure 7B] FIG. 7B is a cross-sectional view of an additional example of a retaining device configured to support a medical container, according to an embodiment of the present disclosure. [Figure 8A] FIG. 8A is a top surface perspective view of another example of a retaining device configured to support a medical container, according to an embodiment of the present disclosure. [Figure 8B] FIG. 8B is a top surface view of the retainer of FIG. 8A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0048] Description of the Invention The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to those skilled in the art. All such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the invention.

[0049] In the following description, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "side", "longitudinal", "transverse" and their derivatives refer to the invention as oriented in the drawing figures. It should be understood, however, that the invention can contemplate alternative variations and step sequences unless expressly specified to the contrary. It should also be understood that the specific devices and steps illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0050] With reference to the figures, the present disclosure is directed to a holding device 10 that includes an opening or cavity for holding a plurality of medical containers, such as a plurality of cartridges, barrels, stoppers, prefilled syringes, and / or prefillable syringes, in an upright position. In particular, the holding device 10 may be configured to simultaneously support a plurality of medical containers in an upright position during packaging, storage, transportation, and / or handling of the plurality of medical containers by an automated filler.

[0051] A medical container, such as a syringe, is generally an elongated structure that includes a hollow elongated barrel that defines a reservoir for containing a medical fluid, a stopper located inside the barrel, and a plunger rod that moves the stopper through the barrel to expel the medical fluid through a tip, fluid port, nozzle, or needle cannula at the end of the barrel. The reservoir of a medical container held by the holding device 10 of the present disclosure can contain less than about 50 mL, or preferably about 1 mL to 10 mL of medical fluid. The medical container can also include a flange at the end of the barrel, which can provide a surface for positioning the user's fingers (e.g., index and middle fingers) while the plunger rod is actuated by the thumb. The holding device 10 can be configured to hold fewer medical containers than most currently available trays or support plates. For example, the holding device 10 can be configured to hold 160 or fewer medical containers, preferably 100 or fewer medical containers, and more preferably 50 or fewer medical containers. For example, the holder 10 may be configured to accommodate 42 medical containers.

[0052] In some examples, the retainer 10 can include plates or surfaces of different heights to increase the stiffness of the retainer 10 and resist deformation of the retainer 10. In particular, the retainer 10 can be configured to resist deformation when the retainer 10 is used with an automated filler such that when the retainer 10 is substantially fully filled with filled medical containers, the retainer 10 deflects downwardly by 2.5 mm or less during filling. Specifically, the retainer 10 can be configured to deflect by approximately 2.5 mm or less for a retainer 10 having a thickness of 1.27 mm with 42 cavities filled with 10 mL medical containers, as determined by finite element analysis (FEA). In contrast, a conventional retainer or plate having a thickness of 1.27 mm and containing 42 cavities but without surfaces of different heights was found by FEA to deflect by more than 20 mm.

[0053] As previously mentioned, the retaining device 10 of the present disclosure is configured to be placed within a container, such as a bath. Exemplary baths are described in the '358 patent, the '793 patent, and the '715 publication referenced above. For example, the retaining device 10 of the present disclosure may be placed across the open top of the bath to cover the interior of the bath. A medical container may be inserted through a through hole or opening in the retaining device 10 such that a distal portion of the medical container (i.e., the portion of the medical container furthest from the portion of the device or container that is to be grasped or manipulated by the user) is within the bath and the sidewall of the medical container is supported by the through retaining portion or opening in the retaining device 10.

[0054] 1A-1C show an exemplary support device 10 configured to support a medical container including features of the present disclosure. The support device 10 comprises a support plate 12 having a first or upper surface 14, a second or lower surface 16, and a peripheral edge 18 extending around the support plate 12 between the upper surface 14 and the lower surface 16. In some examples, the support plate 12 is substantially rectangular having longitudinal sides 20 and transverse sides 22. As used herein, "longitudinal side" refers to the longer side 20 of the support plate 12 having a length L1 (shown in FIG. 1B), and "transverse side" refers to the shorter side 22 of the support plate 12 having a length L2 that is less than the length L1. The support plate 12 may also be square, in which case the longitudinal side 20 and the transverse side 22 are the same length (i.e., L1 is equal to L2). As shown in FIG. 1B, the substantially rectangular support plate 12 defines a first axis X1 (also referred to as the longitudinal, horizontal or x-axis) that extends parallel to a longitudinal side 20 of the support plate 12 and a second axis X2 (also referred to as the transverse, latitudinal, vertical or y-axis) that extends parallel to a transverse side 22 of the support plate 12.

[0055] The dimensions of the support plate 12 will be determined by one skilled in the art based on the number of medical containers that can be supported by the holding device 10, the dimensions of the medical containers, and / or the dimensions of the tank or container to which the holding device 10 is attached. For example, the length L1 can be about 228.8 mm to about 231.2 mm, and the length L2 can be about 197.1 mm to about 199.5 mm. The thickness of the support plate can be about 1.0 mm to about 2.0 mm, preferably about 1.3 mm to about 1.7 mm. In some examples, the dimensions of the support plate 12 can be determined based on published standards for prefilled syringe packaging dimensions (e.g., ISO 11040-7:2015(E): Packaging System for Sterile Subassembled Syringes Ready to Fill).

[0056] The support plate 12 further comprises a plurality of openings 24 therethrough configured to receive the medical containers. The openings 24 are sized to support the medical containers in an upright position. For example, the openings 24 may be wide enough to allow the sidewalls of the medical container to pass through the openings 24 while preventing the flanges or other protruding portions of the medical container from passing through the openings 24. Thus, when the medical container is inserted through one of the openings 24, the flanges of the medical container may seat against the top surface 14 of the support plate 12, thereby holding the medical container in an upright position. The dimensions of the openings 24 generally depend on the size of the medical container intended to be used with the retaining device 10. For example, the inner diameter D1 of the openings 24 (shown in FIGS. 1B and 1C) may be about 18.06 mm to about 19.06 mm for a support plate 12 with 42 openings 24. For a support plate 12 with 100 openings 24, the inner diameter of the openings 24 may be from about 12.1 mm to about 12.35 mm.

[0057] In some examples, the support plate 12 may include 160 or less openings 24, or preferably 50 or less openings 24. For example, the support plate 12 may include 42 openings 24. The openings 24 may be arranged on the support plate 12 as rows and columns. For example, the support plate 12 may include at least 5 rows and at least 5 columns. Because the support plate 12 has a rectangular shape, in some examples, the support plate 12 includes more columns than rows. As shown in Figures 1A and 1B, in one example, the support plate 12 includes 7 columns extending parallel to the transverse or second axis X2 of the support plate 12 and 6 rows extending parallel to the longitudinal or first axis X1. The openings 24 in each column and the openings 24 in each row may be equidistantly spaced. For example, the openings 24 in a row may be spaced apart from adjacent openings 24 in the same row by a distance D2 (shown in Figures 1B and 1C) of about 8.9 mm to about 11.11 mm. Similarly, the openings 24 in a row may be spaced apart from adjacent openings 24 in the same row by a distance D3 (shown in FIGS. 1B and 1C) of between about 8.76 mm and about 11.26 mm.

[0058] In some examples, the openings 24 of the rows and columns are aligned. For example, the openings 24 of adjacent rows may be aligned along an imaginary line V2 extending parallel to the transverse or second axis X2. In particular, for a support plate 12 having seven columns and six rows, as shown in FIGS. 1A and 1B, each row includes seven openings 24 and there is one opening 24 in each column. In other examples, the openings 24 of the rows and / or columns may be offset. For example, each row may include four openings 24. However, the rows may be offset from adjacent rows such that the support plate 12 includes seven columns.

[0059] The support plate 12 may also include notches 26a, 26b extending inwardly from other portions of the peripheral edge 18. For example, as shown in FIGS. 1A and 1B, the support plate 12 includes a first cutout 26a on one of the transverse sides 22 of the support plate 12 and a second cutout 26b on the second transverse side 22 of the support plate 12. The first and second cutouts 26a, 26b may be aligned along the longitudinal direction or first axis X1 of the support plate 12. In some examples, the cutouts 26a, 26b are u-shaped gaps or openings extending inwardly from the peripheral edge 18 of the support plate 12. The retention device 10 may also include a curved wall 28 extending from the upper surface 14 and / or the lower surface 16 of the support plate 12 and around at least a portion of the first cutout 26a and / or the second cutout 26b.

[0060] The retainer 10 further comprises tubular walls, members, or ridges (referred to herein as chimneys 30) protruding from the upper surface 14 and / or the lower surface 16 of the support plate 12. Each chimney 30 is positioned to surround or partially surround one of the openings 24 and guide the insertion of a medical container into the openings 24. The chimneys 30 can include a tubular wall with a cylindrical inner surface 32 having a diameter ID1 (shown in FIGS. 1B and 1C ) substantially the same as a diameter D1 of the opening 24 surrounded or partially surrounded by the chimney 30, and a cylindrical outer surface 34 opposite the inner surface 32 having an outer diameter OD1. For example, for a support plate 12 with 42 chimneys 30, the inner diameter ID1 can be about 18.06 mm to about 19.06 mm and the outer diameter OD1 can be about 18.96 mm to about 21.06 mm, which means that the thickness of the chimneys 30 is about 0.9 mm to about 2.0 mm. The height of the chimneys 30 (e.g., the distance between the upper surface 14 of the support plate 12 and the top of the chimneys 30) can be about 17.23 mm to about 17.73 mm.

[0061] 1A and 1B, the chimney 30 is a tubular structure including a cylindrical interior surface 32 and a cylindrical exterior surface 34. In other examples, the chimney 30 can include axial slits or gaps extending through the chimney 30 that separate the tubular wall of the chimney 30 into separate segments or tabs. For example, the chimney 30 can include two axial slits (not shown) that separate the tubular wall into arcuate guide segments or guide tabs, similar to the slits and guide tabs shown in the previously referenced '715 publication.

[0062] As previously mentioned, the retainer 10 includes structure for increasing the stiffness of the support plate 12 to resist deflection or deformation when the retainer 10 is fully filled with medical containers. In particular, the retainer 10 and the support plate 12 are configured to ensure that the retainer 10 deflects downwardly by no more than 2.5 mm when filled with medical containers. To increase the stiffness of the support plate 12, the surfaces 14, 16 of the support plate 12 can include portions of different heights connected by angled or vertical walls. For example, as shown in FIGS. 1A-1C, the first or upper surface 14 and / or the second or lower surface 16 of the support plate 12 can include a peripheral lower portion 36 extending inwardly from the peripheral edge 18 of the support plate 12. The surfaces 14, 16 of the support plate 12 also include one or more elevated or upper portions 38 surrounded by the peripheral lower portion 36 and one or more upward angled portions 40 extending between the peripheral lower portion 36 and the upper portion 38. The openings 24 and / or chimneys 30 extend through or from all portions 36, 38, 40 of the surfaces 14, 16 of the support plate 12. For example, the exterior openings 24 and exterior chimneys 30 (i.e., the openings 24 and chimneys 30 proximate the peripheral edge 18 of the support plate 12) can extend through or from the peripheral lower portions 36 of the surfaces 14, 16. The exterior openings 24 and chimneys 30 can also extend through or from the upward angle portions 40 of the support plate 12. The interior openings 24 and interior chimneys 30 (i.e., the openings 24 and chimneys 30 surrounded by the exterior openings 24 and / or exterior chimneys 30 proximate the center of the support plate 12) can extend through or from the upper portions 38 of the surfaces 14, 16.

[0063] The peripheral lower portion 36 of the surfaces 14, 16 refers to the lowermost portion of the holding device 10 that is disposed such that when the holding device 10 is disposed on a flat substrate, the peripheral lower portion 36 of the lower or second surface 16 is in surface contact with the flat substrate. The upward angle portion 40 and the upper portion 38 of the surfaces 14, 16 are elevated relative to the peripheral lower portion 36, which means that when positioned on a flat substrate, the angle portion 40 of the lower surface 16 and the upper portion 38 of the lower surface 16 are not in surface contact with the flat substrate.

[0064] In some examples, the surfaces 14, 16 of the peripheral lower portion 36 are flat, meaning that the surfaces 14, 16 of the peripheral lower portion 36 can seat or rest against a portion of a vessel or container to secure the holding device 12 to the vessel or container. In some examples, the holding device 10 can be configured to seat against and / or be supported by parallel rails (e.g., rails that run parallel to either the longitudinal or first axis X1 or the transverse or second axis X2 of the support plate 12). In that case, the parallel rails can be positioned below the flat surfaces of the peripheral lower portion 36 adjacent either the longitudinal side 20 or the transverse side 22 of the holding device 10. Desirably, the support plate 12 is sufficiently rigid to maintain its shape and resist deformation or deflection even when supported only by two parallel rails.

[0065] In some examples, the upper portion 38 of the surfaces 14, 16 may be elevated relative to the peripheral lower portion 36 by a height H1 (shown in FIG. 1C), which may be between about 2.9 mm and about 16.5 mm. In some examples, the height H1 of the upper portion 38 is approximately the same as the height of the chimney 30 (e.g., the height from the first or upper surface 14 of the peripheral lower portion 36 to the top of the chimney 30). In other examples, the height H1 of the upper portion 38 may be less than the height of the chimney 30. For example, the height H1 of the upper portion 36 may be between 60% and 90% of the total height of the chimney 30. In some examples, the upper portion 38 of the surfaces 14, 16 is flat, as described in more detail below. In other examples, the upper portion 38 may comprise a convex or concave surface, as shown in FIGS. 7A and 7B.

[0066] The upward angled portion 40 of the surfaces 14, 16 extends between the peripheral lower portion 36 and the upper portion 38. As previously described, the angled portion 40 can be connected to and / or extend from the exterior chimney 30 of the retention device 10. For example, the angled portion 40 can intersect and / or extend from at least two adjacent exterior chimneys 30 of the retention device 10. In some examples, as shown in FIGS. 1A-1C, the upward angled portion 40 comprises a substantially vertical wall that extends substantially perpendicular to the first or upper surface 14 of the peripheral lower portion 36. In some examples, the substantially vertical wall of the angled portion 40 can have a slight slope, often referred to as a draft angle, to facilitate removal of the retention device 10 from a tool or mold after injection molding. For example, the slight slope or draft angle can be about 0.5 degrees or less.

[0067] 1A-1C, the angular portion extends generally parallel to either the longitudinal or first axis X1 or the transverse or second axis X2 of the support plate 12. In other examples, the angular portion 40 is segmented, for example, including alternating inward angular segments 42 and outward angular segments 44, as shown, for example, in FIGS. 4A and 4B. As described in further detail herein, the inward angular segments 42 may be angled toward the center and / or axes X1, X2 of the support plate 12. The outward angular segments 44 may be angled away from the center or axes X1, X2 of the support plate 12.

[0068] The surfaces 14, 16 of the support plate 12 can include many different arrangements of the lower portion 36, angle portion 40, and upper portion 38 within the scope of this disclosure. Different arrangements can be selected by one of ordinary skill in the art to impart increased stiffness to different portions or sides of the support plate 12 and / or to provide additional support (i.e., resistance to deflection) to portions of the support plate 12 that are expected to be exposed to substantial forces during use.

[0069] In some examples, as shown in Figures 1A-1C, the retaining device 10 includes a support plate 12 having surfaces 14, 16 with a flat peripheral lower portion 36, an upward angle portion 40 with substantially vertical walls, and a single flat upper portion 38 across the center of the support plate 12. As shown in Figures 1A-1C, all of the interior openings 24 extend through the upper portion 38 of the surfaces 14, 16. Furthermore, the height H1 (shown in Figure 1C) of the upper portion 38 is substantially the same as the height of the chimney 30. Additionally, the upward angle portion 40 is substantially parallel to the axis X1, X2 of the support plate 12 and does not include an inward or outward angle segment.

[0070] 2A-2D show another example of a retaining device 10b including multiple lower portions and multiple upper portions. More specifically, as shown in FIGS. 2A-2D, the surfaces 14, 16 of the support plate 12 include a peripheral lower portion 36, an upward angle portion 40 with substantially vertical walls, and an upper portion 38, as in the previous examples. The surfaces 14, 16 of the support plate 12 also include a second or interior lower portion 46 and a second or interior upper portion 48 across the center of the support plate 12. The surfaces 14, 16 also include a downward angle portion 50 extending between the upper portion 38 and the second or interior lower portion 46, and a second or interior upward angle portion 52 extending between the interior lower portion 46 and the interior upper portion 48.

[0071] As previously mentioned, the lower portion 36, 46 is the lowest region of the support plate 12, meaning that the second or lower surface 16 of the lower portion 36, 46 is configured to be in surface contact with the flat substrate when the holding device 10b is placed on the flat substrate. As in the previous examples, the upper portion 38, 48 is elevated with respect to the lower portion 36, 46 by a height H1, which may be the same height as the chimney 30. Furthermore, the angled portion 40, 50, 52 may be a substantially vertical wall extending between the lower portion 36, 46 and the upper portion 38, 48 of the surface 14, 16. As in the previous examples, the angled portions 40, 50, 52 of the surface 14, 16 of the support plate 12 are all parallel to the axis X1, X2 of the support plate 12 and do not include inward or outward angle segments.

[0072] 3A and 3B show another example of a retaining device 10c including multiple lower portions and a single upper portion. More specifically, as shown in FIGS. 3A and 3B, the surfaces 14, 16 include a peripheral lower portion 36, an upper portion 38, and an upwardly angled portion 40 extending between the lower portion 36 and the upper portion 38, as in the previous example. The surfaces 14, 16 also include an interior lower portion 46 surrounded by the upper portion 38, and a downwardly angled portion 50 extending between the upper portion 38 and the interior lower portion 46. As in the previous example, the angled portions 40, 50 are substantially vertical walls that contact the chimney portion 30 of the support plate 12.

[0073] 4A and 4B show another exemplary retainer 10d including a segmented angle portion as previously described. More specifically, as shown in FIGS. 4A and 4B, the retainer 10d includes a support plate 12 including surfaces 14, 16. The surfaces 14, 16 include a peripheral lower portion 36, an upper portion 38, and an upward angle portion 40 extending between the peripheral lower portion 36 and the upper portion 38. As with the previous examples, the upward angle portion 40 comprises a substantially vertical wall that passes through or is connected to the exterior chimney 30 of the retainer 10d. Unlike the previous examples, the upward angle wall of FIGS. 4A and 4B includes an angle segment or portion. Specifically, the portion of the upward angle wall 40 adjacent the transverse side 22 of the support plate 12 is segmented including alternating inwardly oriented segments 42 and outwardly oriented segments 44. As shown in Figure 4B, the inwardly oriented segments 42 are angled in the direction of arrow A1 toward the second or transverse axis X2 of the support plate 12. The outwardly oriented segments 44 are angled in the direction of arrow A2, away from the transverse or second axis X2 of the support plate 12. As shown in Figures 4A and 4B, the portions of the upwardly oriented angled portions 40 adjacent the longitudinal sides 20 of the support plate 12 are straight or flat extending parallel to the longitudinal or first axis X1 of the support plate 12 and are not angled inwardly or outwardly.

[0074] Figures 5A-5G show additional examples of retention device 10e including different arrangements of lower portion 36, upper portions 38, 38a, 38b, and upward angle portion 40. In Figures 5A-5G, upper portions 38, 38a, 38b are represented by cross-hatching. Upward angle portion 40 in Figures 5A-5G is a straight or non-segmented portion that does not include the inwardly or outwardly oriented segments described above.

[0075] For example, FIG. 5A shows a retaining device 10e including a peripheral lower portion 36 and two separate upper portions 38a, 38b surrounded by the lower portion 36. Each of the separate upper portions 38a, 38b is surrounded by a rectangular upward angle portion 40 with vertical walls. The upward angle portion 40 is connected to or passes through both the outer chimney portion 30 and the inner chimney portion 30 of the support plate 12. Similarly, FIG. 5B shows a retaining device 10e including a peripheral lower portion 36 and three separate upper portions 38a, 38b, 38c surrounded by the lower portion 36. Each of the upper portions 38a, 38b, 38c is surrounded by a rectangular upward angle portion 40 with vertical walls. FIG. 5C shows a similar retaining device 10e including a peripheral lower portion 36 and three separate upper portions 38a, 38b, 38c. The three separate upper portions 38 a , 38 b , 38 c are disposed in transverse positions with the central axis of each of the rectangular upper portions 38 a , 38 b , 38 c parallel to a second or transverse axis X 2 of the support plate 12 .

[0076] FIG. 5D shows a retaining device 10e including a support plate 12 having surfaces 14, 16 including a peripheral lower portion 36, an upper portion 38, and an upwardly angled portion 40 between the lower portion 36 and the upper portion 38. The surfaces 14, 16 also include an interior lower portion 46 that is surrounded by the upper portion 38. The surfaces 14, 16 also include a downwardly angled portion 50 that extends between the upper portion 48 and the interior lower portion 46. Similarly, FIGS. 5E and 5F show a retaining device 10e including a support plate 12 having surfaces 14, 16 including a peripheral lower portion 36, an upper portion 38, and an upwardly angled portion 40 between the lower portion 36 and the upper portion 38. The surfaces 14, 16 of FIGS. 5E and 5F also include a plurality of interior lower portions 46a, 46b, 46c, 46d that are surrounded by the upper portion 38. For example, the retainer 10e of Figure 5E includes two interior lower portions 46a, 46b, and the retainer 10e of Figure 5F includes four interior lower portions 46a, 46b, 46c, 46d. The retainer 10e of Figures 5E and 5F also includes separate downward angle portions 50 extending between the upper portion 38 of the surface 14, 16 of each support plate 12 and the separate interior lower portions 46a, 46b, 46c, 46d.

[0077] Figure 5G shows a retainer 10e that includes a peripheral lower portion 36 and an irregularly shaped upper portion 38. Specifically, the irregularly shaped upper portion 38 of Figure 5G includes three long rectangles connected together by two short rectangles. The surfaces 14, 16 of the support plate 12 also include an irregularly shaped upward angle portion 40 that extends around the irregularly shaped upper portion 38 and between the peripheral lower portion 36 and the upper portion 38 of the surfaces 14, 16.

[0078] 6A-6C show a retainer 10f including different arrangements of peripheral lower portion 36, upper portion 38, 38a, 38b, 38c, and angle portion 40 including inwardly oriented segments 42 and / or outwardly oriented segments 44. In FIGURES 6A-6C, other raised surfaces of upper portion 38, 38a, 38b, 38c as well as interior upper portion 48 are represented by cross-hatching. For example, as previously described, segmented angle portion 40 can include alternating inwardly oriented segments 42 angled toward one of axes X1, X2 of support plate 12 and outwardly oriented segments 44 angled away from axes X1, X2 of support plate 12.

[0079] In some examples, as shown in FIG. 6A, the retainer 10f includes a peripheral lower portion 36, an upper portion 38, and a second or inner lower portion 46. The lower and upper portions 36, 38, 46 are connected by segmented angle portions 40, 50. Specifically, as shown in FIG. 6A, the upward angle portion 40 extends between the peripheral lower portion 36 and the upper portion 38. The portion of the upward angle portion 40 proximate the transverse side 22 of the support plate 12 is segmented, including an inwardly oriented segment 42 and an outwardly oriented segment 44. The upward angle portion 40 proximate the longitudinal side 20 of the support plate 12 is linear or flat, extending substantially parallel to the longitudinal or first axis X1 of the support plate 12. The surfaces 14, 16 of the support plate 12 also include a downward angle portion 50 extending between the upper portion 38 and the second or inner lower portion 46. The downward angle portion 50 is segmented, including an inwardly directed portion 42 and an outwardly directed portion 44, in the same manner as the upward angle portion 40 previously described.

[0080] 6B shows a similar retainer 10f including a peripheral lower portion 36, a segmented upward angle portion 40, an upper portion 38, a segmented downward angle portion 50, and a second or inner lower portion 46. As shown in FIG. 6B, the surfaces 14, 16 also include a second or inner upper portion 48 and a segmented inner upward angle portion 52 that extends between the inner lower portion 46 and the second or inner upper portion 48. The surfaces 14, 16 also include a second or inner upward angle portion 52 that extends between the inner lower portion 46 and the inner upper portion 48. The second or inner upward angle portion 52 is segmented including an inwardly oriented portion 42 and an outwardly oriented portion 44 in the same manner as the segmented angle portions previously described.

[0081] 6C illustrates another exemplary retention device 10f that includes a peripheral lower portion 36 and three separate upper portions 38a, 38b, 38c. Surfaces 14, 16 of support plate 12 also include separate upwardly angled portions 40 that extend around each of the separate upper portions 38a, 38b, 38c. As with the previous examples, the portion of upwardly angled surface 40 adjacent transverse side 22 of support plate 12 is segmented to include an inwardly oriented segment or portion 42 and an outwardly oriented segment or portion 44.

[0082] 7A and 7B show additional examples of a retainer 10g. The retainer 10g of FIG. 7A and FIG. 7B includes surfaces 14, 16 including a peripheral lower portion 36, an upwardly angled portion 40, and an upper portion 38. In FIG. 7A, the angled portion 40 is only slightly angled and does not include a vertical wall. In contrast, the angled portion 40 of FIG. 7B includes a vertical wall that connects to or passes through the exterior chimney 30 of the retainer 10g. The upper portion 38 of the surfaces 14, 16 of the retainer 10g of FIG. 7A and FIG. 7B differs from the previous examples because the upper portion 38 is curved or arcuate rather than flat. Specifically, as shown in FIG. 7A, the upper portion 38 of the surfaces 14, 16 is convex. In the retainer 10g of FIG. 7B, the upper portion 38 of the surfaces 14, 16 is concave.

[0083] 8A and 8B show another example of a retainer 10h that includes multiple lower portions and multiple upper portions. Retainer 10h is similar to retainer 10b shown in FIGS. 2A-2D, except that additional openings or holes have been added to reduce the total weight and amount of thermoplastic material required to form retainer 10h. Retainer 10h may be less rigid than the previous examples due to the lower total weight and less material, but retainer 10h is more rigid than a conventional plate or tray that does not include surfaces of different heights.

[0084] More specifically, as shown in Figures 8A and 8B, the surfaces 14, 16 of the support plate 12 include a peripheral lower portion 36, an upwardly angled portion 40 with substantially vertical walls, and an upper portion 38. The surfaces 14, 16 of the support plate 12 also include a second or interior lower portion 46 across the center of the support plate 12 and a second or interior upper portion 48. The surfaces 14, 16 also include a downwardly angled portion 50 extending between the upper portion 38 and the second or interior lower portion 46, and a second or interior upwardly angled portion 52 extending between the interior lower portion 46 and the interior upper portion 48.

[0085] The support plate 12 further includes additional openings or holes 54 for reducing the material of the retention device 10. The openings or holes 54 can be any of a variety of sizes or shapes, including circles, ellipses, squares, or rectangles, as well as elongated grooves or channels extending through the surfaces 14, 16 of the support plate 12. In some examples, the openings or holes 54 can be circles. The circles can have a diameter D4 that is smaller than the diameter D1 of the openings 24 surrounded by the chimney 30. The number and location of the openings or holes 54 can be selected by one of ordinary skill in the art, taking into consideration the importance of reducing the overall weight of the retention device 10 along with the desired stiffness of the retention device 10. For example, as shown in Figures 8A and 8B, the support plate 12 can include 30 openings or holes 54. The openings or holes 54 can be located, for example, in the upper portions 38, 48 and / or the lower interior portion 46 of the surfaces 14, 16 of the support plate 12. In some examples, the lower peripheral portion 36 of the surfaces 14, 16 is devoid of additional openings or holes 54.

[0086] The retention device 10-10h of the present disclosure can be made of various plastic materials commonly used for disposable medical packaging, containers, and / or devices. Additionally, the retention device 10-10h can be manufactured by various forming and molding processes as known in the art. For example, the retention device 10-10h of the present disclosure can be constructed from a thermoplastic material, preferably polypropylene, or polyester, polycarbonate, polyethylene, polyethylene terephthalate, acrylonitrile butadiene styrene, or other injection moldable or moldable resin material as known in the art. In some examples, the support plate 12 and the chimney 30 can be integrally formed from the same material, such as the same thermoplastic material. In some examples, the retention device 10-10h is formed by a single injection molding process, where the retention device 10-10h is formed by injecting a fluid polymeric material between a first tool and a second tool in a single process. To optimize the retention device 10-10h for injection molding, in some examples, the vertical or substantially vertical surfaces of the retention device 10-10h, such as the above-described upward or downward angled surfaces 40, 50, 52 with vertical walls, as well as the interior surface 32 and / or exterior surface 34 of the chimney 30, may include a slightly inclined surface with a draft angle (e.g., an angle of about 0.1 degrees to 4.0 degrees, e.g., 1.0 degrees or 0.5 degrees). Including a substantially vertical surface with a slight incline or draft angle facilitates removal of the molded article from the mold after injection molding. In other examples, the retention device 10-10h may be manufactured by three-dimensional printing by processes known in the art.

[0087] Although examples of the retaining device 10-10h are shown in the accompanying figures and described in detail above, other examples will be apparent to and readily made by those skilled in the art without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative rather than limiting. The invention described above is defined by the appended claims, and all modifications of the invention that come within the meaning and range of equivalency of the claims are embraced within their scope.

Claims

1. a holder configured to support a medical container, 1. A support plate comprising a first surface, a second surface, a peripheral edge between the first and second surfaces, and a plurality of openings through the support plate configured to receive a medical container, the surfaces of the support plate comprising: a peripheral lower portion extending inwardly from said peripheral edge; at least one upper portion surrounded by said peripheral lower portion; and at least one upwardly angled portion extending between said lower portion and said upper portion; and a plurality of chimneys protruding from the first surface and / or the second surface of the support plate at least partially surrounding the plurality of openings, the plurality of chimneys adapted to guide insertion of the medical container into the plurality of openings; A holding device comprising:

2. The retention device of claim 1 , wherein the plurality of openings are arranged on the support plate in a plurality of rows and a plurality of columns.

3. A retaining device as described in any one of claims 1 to 2, wherein the openings in adjacent rows are aligned parallel to a transverse axis of the support plate and the openings in adjacent columns are aligned parallel to a longitudinal axis of the support plate perpendicular to the transverse axis.

4. The retaining device of any one of claims 1 to 3, wherein when fully filled with medical containers, the deflection of the support plate is less than 2.5 mm in the vertical direction.

5. The retention device of any one of claims 1 to 4, wherein the support plate and the plurality of chimneys are integrally formed and made from a thermoplastic polymer.

6. The retaining device of any one of claims 1 to 5, wherein the support plate comprises less than 100 openings.

7. The retaining device of any one of claims 1 to 6, wherein the peripheral lower portion, the upper portion and the angular portion each intersect a chimney of the plurality of chimneys.

8. A retaining device according to any preceding claim, wherein the peripheral lower and upper portions of the surface are flat.

9. The retaining device of any one of claims 1 to 8, wherein the upper portion is elevated relative to the lower portion by a vertical distance of about 2.0 mm to about 14.5 mm.

10. A retaining device according to any preceding claim, wherein the at least one upper portion of the surface is a convex or concave surface.

11. The retention device of any of claims 1-10, wherein the angled portion is substantially vertical, extends substantially perpendicular from the lower portion, and has a draft angle of about 0.1 degrees to about 4.0 degrees.

12. 12. A retaining device according to any preceding claim, wherein the angular portions comprise alternating inwardly angled segments angled towards a centre of the first and / or second surface of the support plate and outwardly angled segments angled away from a centre of the first and / or second surface of the support plate.

13. 13. A retaining device as claimed in any preceding claim, wherein the plurality of chimneys comprise a tubular wall having a cylindrical inner surface having a diameter substantially the same as a diameter of the opening surrounded by the chimneys, and a cylindrical outer surface opposite the inner surface.

14. 14. The retaining device of any of claims 1 to 13, wherein the plurality of openings and the plurality of chimneys are configured to receive a barrel of a syringe or cartridge containing a fluid volume of less than 50 mL.

15. A retaining device as described in any one of claims 1 to 14, wherein the surface of the support plate further includes a second lower portion at least partially surrounded by the upper portion, and a downwardly angled portion extending between the upper portion and the second lower portion.

16. A retaining device according to any preceding claim, wherein the at least one upper portion comprises a first upper portion and a second upper portion separated from the first upper portion by the lower portion.

17. The retaining device of any preceding claim, wherein the first upper portion and the second upper portion each intersect at least one of the plurality of chimneys.

18. A retaining device as described in any one of claims 1 to 17, wherein the surface of the support plate further comprises a second upper portion at least partially surrounded by the second lower portion, and a second upwardly angled surface extending between the second lower portion and the second upper portion.

19. 1. An assembly configured to support a plurality of medical containers, the assembly comprising: tank, and 10. The retention device of claim 1 housed within the vessel. An assembly comprising:

20. 10. A method of manufacturing the retention device of claim 1, the method comprising injection molding or three dimensional printing the support plate and the plurality of chimneys in a single injection molding or three dimensional printing process.

Images