Medical device packaging

Abstract

According to one aspect of this disclosure, a package for a sterile syringe having a nominal size of less than 1 ml may include: a flexible disc having a cavity for receiving the sterile syringe; the cavity may include an opening, one or more sidewalls, and a bottom; a lip surrounding the opening, the lip extending radially outward from the cavity and defining a periphery of the disc; a removable cap having an attachment to the periphery of the lip, and the removable cap being permeable to a gaseous sterilizing agent, the gaseous sterilizing agent including one or more vaporized hydrogen peroxide or ethylene oxide; and a protrusion associated with the bottom of the cavity, the protrusion extending away from the bottom of the cavity in a direction opposite to the opening of the cavity.

Description

Technical Field

[0001] This application claims priority to U.S. Provisional Application No. 62 / 879,906, filed on July 29, 2019, the entire contents of which are incorporated herein by reference.

[0002] Various embodiments of this disclosure relate to packaging for medical devices. Specifically, embodiments of this disclosure can be depicted as blister packs having a protrusion, such as a dome, spherical, or raised portion, connected to the bottom of the pack, such that the protrusion extends away from the device when the device is contained within the blister pack. The protrusion can be used to eject the device from the blister pack. Specifically, the protruding portion can be used to flex the blister pack to remove a syringe, such as a pre-filled syringe, from the blister pack. Prior Technology

[0003] For example, many medical devices are packaged for dispensing to healthcare facilities and / or for storage. Once a healthcare provider is ready to use the device, it can be removed from its package and prepared for patient use as needed. To remove a medical device from its package, the user often needs to handle the device directly by hand, pushing, pulling, lifting, sliding, or otherwise directly touching it. When removing a medical device from its package, excessive handling of the device may not be desirable in certain situations, such as for sterility reasons or to prevent damage. For example, handling syringes, especially pre-filled syringes, during package removal can lead to contamination, which could compromise the sterility of the syringe body, needle, needle attachments, and / or any medications or other fluids contained therein. If the pre-filled syringe is an ophthalmic syringe, handling during package removal can result in contamination of the syringe and / or medication, potentially leading to infectious inflammation of the eye, such as intraocular infections like post-injection endophthalmitis. Furthermore, in the case of pre-filled syringes, if the syringe plunger is bumped during handling, such as when removing the syringe from its packaging, dosing accuracy may be compromised. Dosing accuracy may be even more critical for ophthalmic syringes because the dosage may be relatively small, such as less than or equal to 20 ml, less than or equal to 15 ml, less than or equal to 10 ml, less than or equal to 0.5 ml, or less than or equal to 1 ml. For example, the dosage may be less than or equal to 200 μl, less than or equal to 150 μl, or less than or equal to 100 μl. Therefore, there is a need for a medical device package that reduces the number of direct hand handling operations on the medical device, particularly pre-filled ophthalmic syringes, when removing it from the package. Summary of the Invention

[0004] According to one aspect of this disclosure, a package for a sterile syringe having a nominal size of less than 1 ml may include: a disc having a cavity for receiving the syringe; the cavity may include an opening, one or more sidewalls, and a bottom; a lip surrounding the opening, the lip extending radially outward from the cavity and defining a periphery of the disc; a removable cap having an attachment to the periphery of the lip, and the removable cap being permeable to a gaseous sterilizing agent, the gaseous sterilizing agent including one or more vaporized hydrogen peroxide or ethylene oxide; and a protrusion associated with the bottom of the cavity, the protrusion extending away from the bottom of the cavity in a direction opposite to the opening of the cavity. The protrusion may be made of a deformable material.

[0005] Various embodiments of the package may include one or more of the following aspects: the protrusion may be dome-shaped, and the diameter of the bottom of the dome-shaped protrusion is approximately 10 mm to 20 mm; the cavity may include three cavity portions arranged sequentially along the longitudinal axis of the disk, and the three cavity portions may be connected to each other by narrow portions; the protrusion may be associated with the central cavity portion of the three cavity portions, and wherein the disk may be formed of a suitable thermoplastic material, including one or more of polypropylene, polystyrene, polyethylene, polycarbonate, polyvinyl chloride, or polyethylene terephthalate; when the sterile syringe is accommodated in the cavity, the height of the protrusion from the apex to the bottom of the protrusion may be approximately 5 mm to 6 mm, and the distance between the bottom of the protrusion and a portion of the syringe may be approximately 3 mm to 4 mm; the sterile syringe may be a pre-filled syringe; the disk may include at least two geometric features located on at least one sidewall of the package to facilitate frictional engagement. The syringe is held within the cavity by the fit; or the disc may include a third geometric feature located at the bottom of the cavity, below which the sterile syringe will be accommodated within the cavity.

[0006] On the other hand, this disclosure includes a package comprising: a disc having an opening and a cavity, wherein the cavity includes a plurality of sidewalls and a bottom; a sterile syringe housed within the cavity, wherein the sterile syringe may be pre-filled with a drug; and a spherical protrusion that may be associated with the disc at a position aligned with a portion of the sterile syringe. In a first state, the spherical protrusion may extend away from the sterile syringe in a direction opposite to the opening of the cavity, and in a second state, the spherical protrusion may be reversed such that a portion of the spherical protrusion extends toward a portion of the sterile syringe aligned with the spherical protrusion. The spherical protrusion may be configured to change from the first state to the second state when subjected to pressure.

[0007] Various embodiments of the package may include one or more of the following aspects: in the first state, the spherical protrusion may be positioned under the syringe barrel of the sterile syringe; the cavity may include three cavity portions, wherein the first cavity portion contains the plunger of the sterile syringe, the second cavity portion contains the syringe barrel of the sterile syringe, and the third cavity portion contains the distal portion of the sterile syringe; the three cavity portions may be connected to each other by a central narrow portion, wherein the sterile syringe may extend through the narrow portion; the narrow portion may include a plurality of geometric features protruding into the narrow portion to retain the sterile syringe within the cavity by friction fit; the package may include a removable cap that seals the opening of the cavity opposite the bottom, and the removable cap may be permeable to gaseous sterilizing agents and constitute a sterile barrier. Alternatively, the drug may be one of aflibercept, ranibizumab, bevacizumab, conbercept, OPT-302, brolocizumab, pegylated ankylosing repeat protein (DARPin), or RG7716.

[0008] On the other hand, this disclosure relates to a method for removing an externally sterilized syringe from a package. The method may include: removing a removable cap from a blister pack having a cavity configured to receive the externally sterilized syringe therein, wherein the blister pack has a dome-shaped protrusion associated with and aligned with the bottom of the cavity of the blister pack. The method may further include: pressing a portion of the dome-shaped protrusion toward the cavity of the blister pack, wherein pressing the portion of the dome-shaped protrusion causes a portion of the blister pack to flex. The method may further include orienting the blister pack such that the opening of the cavity faces a sterile surface to release the externally sterilized syringe from the blister pack onto the sterile surface.

[0009] Various embodiments of the method may include one or more of the following aspects: the externally sterilized syringe may be pre-filled with aflibercept, ranibizumab, bevacizumab, conbercept, OPT-302, RTH258 (brolocizumab), PEGylated ankylosing repeat protein (DARPin), or RG7716; the blister pack may be made of one or more materials including polypropylene, polystyrene, polyethylene, polycarbonate, polyvinyl chloride, or polyethylene terephthalate; the removable cap may be permeable to a gaseous sterilizing agent; the gaseous sterilizing agent may be vaporized hydrogen peroxide or ethylene oxide.

[0010] On the other hand, this disclosure relates to a method for removing an externally sterilized syringe from a package comprising: a disc having a cavity, a deformable protrusion associated with the cavity, and an opening covered by a gas-permeable material. The method may include: removing the gas-permeable material to expose the opening of the disc; deforming the protrusion into the cavity and toward the syringe barrel of the externally sterilized syringe, wherein the step of deforming the protrusion also causes a portion of the disc to flex; and ejecting the externally sterilized syringe from the disc.

[0011] Various embodiments of the method may include one or more of the following aspects: ejecting the externally sterilized syringe from the tray can be performed without direct user handling of the syringe; the gas-permeable material can be permeable to vaporized hydrogen peroxide or ethylene oxide; the deformable protrusion can be spherical; or the externally sterilized syringe can be pre-filled with aflibercept, ranibizumab, bevacizumab, conbercept, OPT-302, RTH258 (brolocizumab), PEGylated ankylosing repeat protein (DARPin), or RG7716.

[0012] On the other hand, the present invention relates to a method for removing an externally sterilized syringe from a package comprising: a disc having a cavity and an opening covered by a gas-permeable material. The method may include: removing the gas-permeable material to expose the opening of the disc; deforming a portion of the cavity toward the syringe barrel of the externally sterilized syringe, thereby flexing a portion of the disc; and ejecting the externally sterilized syringe from the disc.

[0013] Various embodiments of the method may include one or more of the following aspects: ejecting the externally sterilized syringe from the tray can be performed without the user touching the externally sterilized syringe with bare hands; the gas-permeable material can be permeable to one or more vaporized hydrogen peroxide or ethylene oxide; or the externally sterilized syringe can be pre-filled with aflibercept, ranibizumab, bevacizumab, conbercept, OPT-302, RTH258 (brolocizumab), PEGylated ankylosing repeat protein (DARPin), or RG7716. Simple Explanation of the Diagram

[0014] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. The drawings illustrate different aspects of this disclosure, and where appropriate, similar structures, components, materials, and / or elements in different figures are labeled with similar reference numerals. It should be understood that, apart from those specifically shown, various combinations of structures, components, and / or elements are conceivable and fall within the scope of this disclosure.

[0015] Numerous inventions are described and illustrated herein. These inventions are not limited to any single aspect or embodiment thereof, nor to any combination and / or variation of such aspects and / or embodiments. Furthermore, each aspect of the invention and / or its embodiments may be used alone or in combination with one or more other aspects of the invention and / or its embodiments. For the sake of brevity, certain permutations and / or combinations are not individually discussed and / or shown herein. It is important to note that embodiments or implementations described herein as "exemplary" should not be construed as being preferred or advantageous, for example, with respect to other embodiments or implementations; rather, they are intended to reflect or indicate that such embodiments are "illustrative" embodiments.

[0016] According to an embodiment of this disclosure, FIG1 provides a perspective view of an exemplary package.

[0017] According to an embodiment of this disclosure, FIG2 provides a bottom view of an exemplary package accommodating a syringe.

[0018] According to an embodiment of the present disclosure, FIG3A provides a cross-sectional view of the package of FIG2 including the syringe.

[0019] According to an embodiment of the present disclosure, FIG3B provides a cross-sectional view of the package of FIG2 containing a syringe that is partially ejected in a flexed state.

[0020] According to an embodiment of this disclosure, FIG4 provides a top view of an exemplary package.

[0021] According to an embodiment of this disclosure, FIG5 provides a perspective view of an exemplary package.

[0022] According to an embodiment of this disclosure, FIG6 provides a bottom view of an exemplary package including a syringe.

[0023] According to an embodiment of this disclosure, FIG7 provides a perspective view of an exemplary package.

[0024] According to an embodiment of this disclosure, FIG8 provides a bottom view of an exemplary package including a syringe.

[0025] According to an embodiment of this disclosure, FIG9 provides a bottom view of an exemplary package containing a printed syringe.

[0026] The terms “comprising,” “including,” or any other variations thereof, as used herein, are intended to cover a non-exclusive inclusion, meaning that a process, method, article, or apparatus that includes a list of elements may include not only those elements but may also include other elements not expressly listed or inherent to such a process, method, article, or apparatus. The term “exemplary” is used in the sense of “example” rather than “ideal.” Furthermore, the terms “first,” “second,” etc., do not indicate any order, quantity, or importance herein, but are used to distinguish an element or structure from another. Additionally, the terms “an” and “a” used herein do not indicate a quantity limitation but rather indicate the presence of one or more of the referenced items.

[0027] The term "distal" or any variation thereof refers to the part of the device furthest from the operator during an injection procedure. For example, the distal end of a syringe would be the needle tip. Conversely, the term "proximal" or any variation thereof refers to the part of the device closest to the operator during an injection procedure. For example, the proximal end of a syringe would be the plunger tip. Furthermore, as used herein, the terms "approximately," "substantially," and "about" generally mean + / - 10% of the indicated value.

[0028] As used in this disclosure, the term "sterilization" refers to achieving a level of sterility suitable for formulation of a pharmaceutical substance or pharmaceutical product for commercial sale and use. Such a level of sterility may be defined in, for example, regulatory guidelines or regulations, such as those issued by the U.S. Food and Drug Administration. In some embodiments, such a level of sterility may include, for example, a 6-log reduction in the microbial community of a biological indicator placed on the outer or inner surface of a pharmaceutical product (e.g., the outer surface of a syringe or the inner surface of a blister pack). In other embodiments, such a level of sterility may include, for example, a 9-log or 12-log reduction in the microbial community of a biological indicator. Sterilization means achieving this appropriate level of sterility while also achieving a sufficiently low level of residual sterilizing chemicals (e.g., vaporized hydrogen peroxide, ethylene oxide, etc.) for commercial distribution and use. This low level of residual sterilizing chemicals may also be defined in regulatory guidelines or regulations.

[0029] As used in this disclosure, the term "external sterilization" refers to sterilization of a container or encapsulation, such as in a primary encapsulation component, or in a drug delivery device in both primary and secondary encapsulation components, suitable for commercial distribution and use. Implementation

[0030] Embodiments of this disclosure relate to the packaging of medical devices, and more particularly to packaging for syringes (e.g., pre-filled syringes). In some embodiments, the packaging may be configured to contain an externally sterilized syringe. In particular, embodiments of this disclosure may be directed to packaging for externally sterilized pre-filled syringes containing ophthalmic medications. Exemplary ophthalmic syringes may be pre-filled with, for example, 50 mL or less, 20 mL or less, 15 mL or less, 10 mL or less, 5 mL or less, or 1 mL or less of ophthalmic medication. In some embodiments, exemplary packaging may have a nominal size of less than 1 mL. Exemplary syringes are described in PCT / US2020 / 036200, which is incorporated herein by reference in its entirety. The packaging may include one or more features to facilitate removal of the medical device from the packaging. For example, the packaging may include one or more deformable protrusions that may be reversed, pushed, and / or otherwise deformed to remove, eject, push, or otherwise move the medical device to release it from the packaging. The package can also be flexible, allowing the user to push the protrusions to bend or flex the package, thereby causing the medical device contained therein to be released.

[0031] In some exemplary embodiments, the deformable portion(s) may include protrusions such as dome-shaped mounds or other spherical protrusions associated with the bottom of the package, wherein the medical device, such as a syringe, is configured to be positioned above the bottom of the package when it is housed within the package. The protrusions may extend outward away from the location where the medical device is configured and may contact the outer surface of the package.

[0032] To facilitate removal of the medical device from the package, the user can orient the package so that the opening is angled toward the surface on which the medical device will be ejected. The user can also push the protrusions to flex the package, so that the central portion of the package bends toward the medical device as one or more edges bend away from it. For example, the user can push the protrusions and tilt or flip the package sideways while flexing the package to release the syringe from the tray onto a sterile surface such as a sterile table, tray, cloth, or pad. When the opening of the package is angled downwards under gravity, the flexing of the package allows the medical device to be released from the package, for example, ejected onto a surface, with the user only touching the package and not directly contacting the medical device.

[0033] The protrusion can also be at least partially reversed. The reversed portion of the protrusion may or may not contact the medical device housed within the package to aid in ejecting the medical device from the package. In some embodiments, pushing the protrusion to flex the package may be sufficient to eject the device, while in other embodiments, reversing the protrusion may push a portion of the medical device (e.g., the syringe syringe) to facilitate ejection of the device from the package. In practice, the protrusion may serve as a central marker or target for the user to push, flexing the package to eject the device. The protrusion may include, for example, an arrow or other visual identifier to indicate to the user to push the package in a central position to flex the package and eject the syringe. Exemplary aspects of the package are described in further detail herein.

[0034] Figure 1 shows a bottom view of an exemplary package 100 for a medical device. Specifically, the package 100 may be designed to house a drug delivery device, such as a pre-filled syringe. The exemplary pre-filled syringe can be used for the treatment of any ophthalmic condition, including patients with neovascular (wet) age-related macular degeneration (AMD), retinal vein occlusion (RVO), diabetic macular edema (DME), and / or diabetic retinopathy (DR). In particular, macromolecular and small molecule antagonists of VEGF and / or ANG-2, such as aflibercept (Eylea®), ranibizumab (Lucentis®), bevacizumab (Avastin®), conbercept, OPT-302, RTH258 (brolocizumab), peciparic acid repeat protein (DARPin)-like abicipar pegol, or RG7716, can be used with the exemplary syringe. Embodiments of this disclosure can also be used in cosmetic applications or medical dermatology, such as the treatment or diagnosis of allergic reactions. Package 100 includes: a disc 8 in which the syringe is housed during storage; and a lip 9 extending around the periphery of the disc 8 and defining an opening within the disc 8. The top of the disc 8 (as shown in FIG. 4) can be sealed with a removable cap 28 (FIG. 3A) that can enclose the syringe within the disc 8 during sterilization and / or storage. In some embodiments, the package 100 may be a blister package, that is, the package 100 may be a pre-formed plastic package, and the disc 8 may be made of a formable web material, such as thermoformable plastic.

[0035] Encapsulation 100 is suitable for use with external sterilization processes, such as vaporized hydrogen peroxide (VHP) sterilization and / or ethanol sterilization. Therefore, a medical device (e.g., a pre-filled syringe) can be encapsulated within encapsulation 100 and then externally sterilized. Sterilizing agents such as VHP may not affect the medication contained within the syringe, but may sterilize the outer surface of the syringe. Exemplary sterilization processes are described in PCT / US2018 / 021013, the entire contents of which are incorporated herein by reference. The materials used in encapsulation 100 may be semi-permeable to sterilizing agents, allowing the sterilizing agent to permeate part or all of encapsulation 100, thereby sterilizing both the exterior of the medical device contained within encapsulation 100 and the interior of encapsulation 100 when the medical device is sealed within encapsulation 100. For example, at least 75%, at least 80%, at least 85%, at least 90%, or at least 95% of encapsulation 100 may be sterilized. For example, the removable lid 28 (Figure 3A) may be permeable to vaporized hydrogen peroxide and / or ethanol. The lid 28 may be formed from, for example, Tyvek or other suitable high-density polyethylene fibers, ethylene-vinyl acetate, and / or other thermoplastic materials. In some embodiments, the tray 8 may include an indicator to allow a user to determine whether the tray 8 and its contents have been sterilized. For example, the tray 8 may include an indicator (such as tape or a label) that changes color or pattern appearance to visually indicate whether a sterilization process has been performed.

[0036] As described herein, the package 100 is designed for use with external sterilization processes and allows the user to remove the contents of the package 100 without directly handling the contents, reducing the likelihood of compromised sterility of the contained medical device. Consequently, as described herein, the package 100 can also reduce the chance of infection of the user from the medical device. For example, if the package 100 contains an ophthalmic syringe, it can reduce the risk of eye infections, such as post-injection endophthalmitis, caused by a contaminated syringe.

[0037] External sterilization of syringes means that any living organisms on the syringe surface have been eliminated or killed, so that even if they remain, they cannot survive. External sterilization can be performed on the outer surface of the syringe plunger rod, the flange, the rear surface of the piston, the interior of the syringe barrel behind the piston, and any other external surface of the syringe. In some cases, depyrogenation and / or other removal processes may be performed prior to external sterilization.

[0038] The tray 8 may include a cavity 3 configured to receive the distal portion of a syringe. The distal end of the syringe may include, for example, a luer lock and / or a syringe attachment, to which a needle can be attached once the syringe is removed from the tray 8 for use. In other embodiments, the needle may already be attached to a syringe within the package 100 and may be further covered by a needle cap during storage within the package 100. The cavity 2 may be configured to receive at least a portion of the syringe barrel (which may be a glass or plastic material compatible with sterilizing agents) and a cavity 5 configured to receive the flange and / or plunger of the syringe. The cavity 5 may be shaped to correspond to the flange and / or plunger of the syringe, as shown in FIG1. ​​For example, the flange portion 6 of the cavity 5 may correspond to the shape of a flange. Comparing FIG1, FIG5, and FIG7, the shape and / or sidewalls of the flange portion 6 of the cavity 5 may be circular to receive the flange of the syringe. Comparing Figures 2, 6 and 8, the internal region of the flange portion 6 of the cavity 5 can be configured, for example, to include a circular sidewall to accommodate the flange of the syringe.

[0039] In some aspects, the syringe housed in the disc 8 may include a larger plunger rod or a larger portion of the plunger rod compared to a standard syringe, to increase the stability of the clinician's hand when pushing the plunger rod, such as during intravitreal injections (Figures 7 and 8). In this respect, the size and shape of the package 100 may be configured to accommodate a larger plunger rod. If the syringe housed in the disc 8 includes a protective plunger stop, cap, and / or other elements to prevent movement of the syringe plunger and / or dispensing of medication within the syringe, the cavity 5 may be shaped to reflect the profile of the flange and / or plunger with the protective elements. However, in other embodiments, the cavity 5 may be substantially rectangular, elliptical, or any other suitable shape, provided that the internal area of ​​the cavity 5 defines a space large enough to accommodate the proximal portion of the syringe, and includes any accompanying protective elements, if applicable. For example, Figures 5 and 6 show an exemplary embodiment in which the longitudinal sidewalls of the cavity 5 are generally flat and parallel to at least a portion of the plunger rod of the syringe. Figures 7 and 8 illustrate an exemplary embodiment in which the cavity 5 may include a recessed portion 11, the shape of which is configured to correspond to at least a portion of a flange or plunger, such as a protective plunger stop, cap, and / or other element, to prevent movement of the syringe plunger and / or dispensing of medication within the syringe. For example, the recessed portion 11 may be located between the main area of ​​the cavity 5 and the flange portion 6. In an exemplary embodiment, such as in Figure 5, the shape and dimensions of the cavity 5 may be configured to facilitate high-speed manufacturing of the package 100 and / or improve the material distribution of the package 100.

[0040] Similarly, although cavity 3 is shown as substantially rectangular and cavity 2 as substantially square in the exemplary embodiment of FIG1, cavities 3 and 2 can be of any suitable size and / or shape to accommodate the distal end of the syringe (and any cap associated with that distal end) and at least a portion of the syringe barrel, respectively. For example, cavities 2 and 3 can be elliptical, circular, trapezoidal, or wider or narrower rectangles, or any combination thereof. The dimensions of cavities 2, 3, and 5 can be configured to provide space between the cavity walls and the syringe to allow the sterilizing agent to circulate within package 100 during sterilization, thereby sterilizing the inner surface of package 100 and the outer surface of the syringe. Furthermore, tray 8 and cavities 2, 3, and 5 can have substantially flat surfaces on their top and bottom (e.g., cap 28 and bottom) to allow multiple packages to be stacked on top of each other during storage. The flat surfaces also allow for consistent placement in an autoclave. In other words, in some embodiments, cavities 2, 3, 5 and disk 8 may have a circular, such as cylindrical, shape, or any other suitable shape. Furthermore, disk 8 may have rounded or pointed corners and / or edges. In exemplary embodiments, for example, referring to FIG5, the shape and / or size of cavities 2, 3, 5 and disk 8 may be configured to facilitate high-speed manufacturing of package 100 and / or improve the material distribution of package 100.

[0041] In the embodiments of Figures 1, 5, and 7, the narrow portion 7 extends between cavities 2 and cavities 3 and 5, fluidly connecting all three cavities. As can be seen in Figures 2, 6, and 8, the space of the narrow portion 7 is configured to accommodate the syringe barrel therein, allowing the syringe to extend into all three cavities when contained within the package 100. For example, in Figures 2, 6, and 8, as described above, the plunger flange 14 of the packaged syringe is located within the flange portion 6 of cavity 5, the syringe barrel 12 extends within the narrow portion 7 and through cavity 2, and the distal region of the syringe is located within cavity 3, at least partially covered by a protective element 15 (e.g., a Luer lock).

[0042] Although the disc 8 is shown as comprising three cavities 2, 3, 5 extending along longitudinal axis 22 (Figures 2, 6, and 8) and connected to each other by a narrow portion 7, it is conceivable that the disc 8 may have any suitable number of cavities. For example, it may include a single cavity of substantially equal depth to hold a medical device, may include two cavities, or may include three or more cavities. Each cavity (in embodiments with multiple cavities) may be connected to each other, thereby allowing them to accommodate medical devices in combination. Alternatively, if multiple medical devices or components are accommodated in the disc 8, the disc 8 may include multiple cavities that are not connected to each other. In such embodiments, it is conceivable that one of the multiple cavities may include a protrusion to facilitate removal of the medical device and / or component from the disc 8, as will be further described below.

[0043] In the embodiments of Figures 1 and 2, the cavity 2 includes a dome 4 at the bottom of the package 100. The dome 4 may be a flexible, hollow protrusion in the disk 8, configured to facilitate removal of the syringe from the package 100. The dome 4 is connected to the bottom of the cavity 2 such that when the syringe is contained within the package 100, the dome 4 is oriented below the syringe. In the embodiment shown in Figure 2, the dome 4 is aligned with the central region of the syringe barrel 12. The dome 4 may be made of, for example, a compressible material that deforms under pressure applied by the user. The dome 4 may be made of the same material as the rest of the disk 8, or it may be formed of a different, for example, a relatively more flexible material. In some embodiments, as described above, the dome 4 and the disk 8 may be thermoformed plastics. For example, the dome 4 and / or the disk 8 may be formed of polypropylene, polystyrene, polyethylene, polycarbonate, polyvinyl chloride, or polyethylene terephthalate (PETG). The diameter of the bottom of the dome 4 (e.g., the widest part where the bottom of the dome 4 intersects with the bottom of the disk 8) can be approximately 10 mm to 20 mm, for example, approximately 10 mm, approximately 11 mm, approximately 12 mm, approximately 13 mm, approximately 14 mm, approximately 15 mm, approximately 16 mm, approximately 17 mm, approximately 18 mm, or approximately 19 mm. Referring to Figure 5, compared to Figure 1, the diameter of the bottom of the dome 4 can be set to facilitate high-speed manufacturing of the package 100 and / or improve the material distribution of the package 100.

[0044] Figure 3A depicts a cross-sectional view of a disc 8 containing a syringe (e.g., an empty or pre-filled syringe containing ophthalmic medication). As described above, when the syringe is contained in the disc 8, the dome 4 protrudes outward from the bottom of the disc 8 away from the syringe, and the dome 4 is aligned with and positioned below (or above, depending on the orientation of the disc 8) the syringe barrel 12. To remove the syringe from the package 100, the removable cap 28 can be removed, for example, peeled off, the disc 8 can be tilted sideways or upside down to position the opening of the package facing the surface, and the dome 4 can be pushed by the user. The user can use one or more fingers, such as the thumb, to push the dome 4 toward the syringe contained within the package. When the user pushes the dome 4, the package may flex, so that the central portion of the package bends toward the medical device, while one or more edges of the package bend away from the medical device. When the package 100 flexes (Figure 3B), this may cause the syringe to be removed from the package. Because the package 100 is oriented to face the opening downwards due to gravity (or at least perpendicular to the surface below), the syringe can be ejected from the package 100 and fall onto that surface. Therefore, pushing the dome 4 and flexing the package 100 allows the user to remove the syringe from the package 100 without direct contact with the syringe. When the package 100 is inverted, the syringe may not fall off on its own; the package 100 may suspend and hold the syringe until the user flexes the package 100, for example, by pushing the dome 4.

[0045] When a user pushes the dome 4 to flex the disk 8, the dome 4 can deform and can at least partially reverse. When the dome 4 reverses, it may or may not be configured to contact the syringe barrel 12. In some embodiments, the dome 4 may push the syringe barrel 12 to assist in ejecting the syringe from the package 100. In this embodiment, the height of the dome 4 from its apex to the bottom of the cavity from which it extends may be greater than the distance from the bottom of the cavity to the location of the medical device (e.g., the syringe) within the disk 8. As used herein, the term "apex" refers to a portion of the dome 4 that is further away from the bottom of the cavity extending from the dome 4, regardless of the relative orientation of the dome 4 and the disk 8. In one embodiment, the syringe may be housed within the disk 8 such that the height of the dome 4 from its apex to the bottom of the disk 8 is approximately 5 mm to 6 mm, and the distance between the bottom of the disk 8 and the bottom of the syringe covering the dome 4 is approximately 3 mm to 4 mm. However, in other embodiments, the dome 4 may not contact the syringe barrel 12 when pressed by the user. Instead, the deflection of the disc 8 caused by the downward orientation of the opening of the disc 8 due to gravity due to pressing the dome 4 may be sufficient to remove the syringe from the disc 8 and cause the syringe to be ejected onto a surface (preferably a sterile surface).

[0046] The user can push the dome 4 to flex the tray 8 before, during, and / or after orienting the tray 8, so that the opening of the tray 8 faces downward or sideways toward the surface to which the syringe is to be ejected (i.e., rotating the tray 8 so that the opening faces downward due to gravity). Orienting the tray with the opening facing the surface allows the syringe to fall from the tray 8 onto a suitable sterile surface without the user having to handle the syringe directly to remove it from the package. Reducing the number of times the user handles the syringe reduces the possibility that the syringe and / or its contents may be contaminated and infect any part of the body injected with the syringe contents. For example, a sterile ophthalmic syringe can be contained within the package 100, and the dome 4 and the package 100 allow the user to remove the syringe without compromising sterility, which can ultimately reduce the risk of eye infections such as post-injection endophthalmitis caused by a contaminated syringe. Reducing handling of the syringe also reduces the risk of some medication being accidentally expelled from the syringe when it is removed from the package 100.

[0047] The location of protrusions, such as those on the dome 4 and / or other protrusions on the disc 8, not only facilitates syringe removal but also guides the user on how to handle certain portions of the package 100 when removing the syringe from the package 100. For example, in some embodiments, the dome 4 or other portions of the package 100 may include markings, labels, and / or tactile features (e.g., ridges, bumps, or grooves) that indicate where the user should press to flex the disc 8 and remove the syringe from the package 100. Overall, including other suitable protrusions in the dome 4 or disc 8 can reduce one or more possibilities of injury to the user, damage to the device, loss of sterility of the device or any medication therein, and / or accidental release of medication within the device.

[0048] In some embodiments, pushing the dome 4 and / or bending or flexing the disc 8 can release the syringe from the friction-fitted portion of the disc 8. For example, as shown in FIG. 4, the narrow portion 7 may include one or more geometric features 17 protruding into the narrow portion to retain the sterile syringe within the cavity by friction fit. The geometric features 17 may be located on the sidewalls and / or bottom of the narrow portion 7 to position the syringe barrel 12 within the narrow portion 7. To encapsulate the syringe within the disc 8 so that the encapsulation 100 facilitates sterilization, for example, by reducing the contact area with the syringe to allow the maximum surface area of ​​the syringe to be used for sterilization while still retaining it, and by suspending the syringe in the disc 8 during inversion, the syringe can be pushed into the disc 8, causing the syringe barrel 12 to slide past the geometric features 17, resulting in a friction-fitted syringe within the disc 8. Once the syringe barrel 12 is pushed into the disc 8, the geometric features 17 retain the syringe barrel 12 within the narrow portion 7 and hold the syringe within the disc 8. The dome 4 can be pressed to flex the disc 8 and / or push the syringe barrel 12 upwards, thereby moving the syringe barrel 12 past the geometry 17 and releasing the syringe from the disc 8. For example, bending the disc 8 can force the portion of the disc 8 including the geometry 17 to move away from the syringe and thus release the syringe. Therefore, the dome 4 can be used in conjunction with other friction-fitting portions of the disc 8 to facilitate the release of the syringe from the disc 8.

[0049] One or more geometric features 17 located at the bottom of the narrow portion 7 can work in conjunction with geometric features 17 on the sidewalls of the narrow portion 7 to orient the syringe so that, when the syringe is contained within the package 100, it does not directly contact the sidewalls of the narrow portion and / or any other cavities, such as cavities 2, 3, 5. This allows the sterilizing agent within the package 100 to circulate around the outer surface of the syringe within the package 100. By including geometric features 17 to hold the syringe in place while being separated from the inner surface of the package, the geometric features 17 can reduce the surface area of ​​the syringe in contact with the inner wall of the package 100, and thus can increase the surface area of ​​the syringe exposed to the sterilizing agent within the package 100.

[0050] Although three geometric features 17 are depicted in each narrow portion 7 of Figure 4, it is conceivable that fewer (e.g., two) or more than three geometric features 17 may be included in each narrow portion 7. Furthermore, geometric features 17 may also be included in any suitable portion of the disk 8, including any combination of cavities, in place of narrower portions such as narrow portion 7, or in addition to narrower portions such as narrow portion 7.

[0051] Although the dome-shaped portion is referred to herein, those skilled in the art to which this invention pertains will understand that the protrusions on the disc 8 can have any suitable shape, as long as they can be pushed to flex the disc 8 and / or compressed to an inverted position. Furthermore, although the disc 8 is described as comprising three cavities 2, 3, 5 connected to each other by narrow portions 7, it is conceivable that the disc 8 can have any suitable shape with one or more cavities to accommodate a medical device. For example, although embodiments of this disclosure are described as packaging for syringes such as pre-filled syringes, it should be understood that protrusions such as domes 4 can be used in conjunction with packaging and / or consumer products for any suitable medical device. Therefore, the disc 8 can be shaped to accommodate other types of medical devices. Additionally, multiple protrusions such as multiple domes 4 can be incorporated into the disc 8 to facilitate the removal of medical devices therefrom.

[0052] As described above, using a dome 4 in a package, such as a blister pack, to release the syringe contained within the package can improve the sterility, dosing accuracy, and / or safety of the syringe and the user, because it reduces the number of times the user must directly handle the syringe before administering the contents to a person. This, in turn, reduces the risk of accidental ejection of the syringe contents before drug administration and decreases the incidence of human infection.

[0053] Referring back to Figures 1 and 2, the package 100 may further include a lip 9 extending around at least a portion of the disk 8 and defining an opening in the disk 8. The lip 9 allows a removable, for example, peelable cap 28 to be sealed over the top opening of the disk 8 to accommodate a medical device within the disk 8 during storage. An adhesive 18, such as glue, paste, film, tape, pressure-sensitive material, and / or cold adhesive, may be used to seal the removable cap 28 to the lip 9. The adhesive 18 may be compatible with the type of external sterilization that may be performed on the package 100. The width of the adhesive 18 may vary depending on the size of the top opening of the disk 8; for example, increasing the size of the top opening of the disk 8 will decrease the width of the adhesive 18. Corners of the lip 9, such as corner 16 in Figure 2, may be free of adhesive 18 to allow a user to lift the removable cap 28 from corner 16 to remove it from the disk 8. As shown in Figures 6 and 8, corner 16 may include tabs 20 (or other protrusions or recesses) to allow a user to lift the removable cap 28 from corner 16 to remove the cap 28 from the tray 8. Tabs 20 may be included on corner 16 of the lip 9 or on the removable cap 28. In an exemplary embodiment, referring to Figures 2 and 6, the type, shape, and / or size (or other protrusions or recesses) of the lip 9 or tabs 20 may be configured to facilitate high-speed manufacturing of the package 100 and / or improve the material distribution of the package 100. The removable cap 28 may be made of any suitable material, such as foil, plastic, etc., and may be permeable to suitable gaseous sterilizing agents such as vaporized hydrogen peroxide or ethanol.

[0054] In use, the user can first remove the removable cap 28 from the disc 8, for example, by peeling the cap 28 off the lip 9, to expose the opening of the disc 8. The user can then orient the opening of the disc 8 laterally or vertically so that the opening faces the surface to which the medical device (e.g., a pre-filled ophthalmic syringe) is to be ejected. Subsequently or simultaneously, the user can push the dome 4 (or other protrusion), which flexes the disc 8, causing the central portion of the encapsulation to bend toward the medical device, while one or more edges of the encapsulation bend away from the medical device. Pushing the dome 4 can at least partially reverse the dome 4. In some embodiments, the reversed portion of the dome 4 may contact the medical device (e.g., syringe barrel 12), while in other embodiments, the dome 4 may never contact the syringe. Pushing the dome 4 and flexing the disc 8 can thus eject the medical device from the disc 8, so that the medical device falls onto the surface facing the opening oriented toward the disc 8. Suitable sterile surfaces may include, for example, sterile tables, trays for holding the medical device, cloths, pads, or any other suitable sterile surfaces. The combination of pushing dome 4, reversing dome 4, bending disc 8, and / or tilting disc 8 to the side or flipping it upside down so that the bottom of disc 8 is oriented above the syringe and above the sterile surface, allows the user to remove the syringe without actually touching it directly.

[0055] In some embodiments, pressing the dome 4 and the flexural disk 8 can also release the medical device from a friction-fitting portion of the disk 8, such as one or more geometric features 17. Once the syringe is released from the disk 8 (e.g., via reversal and / or bending of the dome 4), rotating the disk 8 can cause the syringe to fall out. In embodiments that include multiple domes 4 (or multiple other protrusions), multiple domes 4 can be pressed to release different portions of the medical device and / or the flexural disk 8 from the disk 8.

[0056] In the case of packaging for pre-filled syringes, once the syringe is released from disc 8, any other packaging on the syringe (e.g., distal protectors or Luer locks and / or plunger protectors) can be removed from the syringe. In some embodiments, the syringe may be contained in package 100 without a needle, and a needle, such as a stake needle, may be attached to the distal end of the syringe, for example, via a needle attachment. The contents of the syringe (e.g., macromolecular and / or small molecule antagonists of VEGF and / or ANG-2, such as aflibercept (Eylea®), ranibizumab (Lucentis®), bevacizumab (Avastin®), conbercept, OPT-302, RTH258 (brolocizumab), pecipar pegol (DARPin-like glycosides), or RG7716) can then be injected into the recipient's eye.

[0057] As described above, the components of package 100 and the dimensions and / or shapes of such components can be configured to facilitate high-speed manufacturing of package 100 and / or improve the material distribution of package 100. FIG9 is an exemplary embodiment illustrating a portion of the manufacturing process of package 100, wherein, for example, packages 101a, 101b and 101c are sealed by material 30 to form a removable cap 28 (FIG. 3), which may be, for example, Tavico or other suitable high-density polyethylene fiber, ethylene-vinyl acetate and / or other thermoplastic materials.

[0058] The descriptions and examples above are illustrative and not restrictive. Many modifications and / or alterations can be made by those skilled in the art to which this invention pertains without departing from the overall scope of the invention. For example, and as referenced, the above embodiments (and / or aspects thereof) can be combined with each other. Furthermore, a portion of the above embodiments can be removed without departing from the scope of the invention. Additionally, modifications can be made without departing from its scope to adapt particular situations or aspects to the teachings of various embodiments. Many other embodiments will also be apparent to those skilled in the art upon review of the above description.

[0059] 2: Cavity 3: Cavity 4: Dome 5: Cavity 6: Flange portion 7: Narrow section 8: Plate 9: Lips 11: Recessed portion 12: Syringe syringe 14: Plunger flange 15: Protective components 16: Corner 17: Geometric Features 18: Adhesive 20: Convex plate 22: Longitudinal axis 28: Cover 30: Materials 100, 101a, 101b, 101c: Package

Claims

1. A package for a syringe, characterized in that it comprises: A tray having a bottom that defines a cavity for receiving the syringe, wherein the cavity includes: a first cavity; A second cavity, which is separated from the first cavity by a first narrow portion disposed between the second cavity and the first cavity; and a third cavity, which is separated from the second cavity by a second narrow portion disposed between the third cavity and the second cavity; wherein the width and depth of the cavities at the first narrow portion and the second narrow portion are smaller than the width and depth of the cavities at the first cavity, the second cavity and the third cavity respectively; and wherein the bottom is configured to abut against a portion of the syringe contained in the first narrow portion and the second narrow portion to elevate the syringe within the cavity based on the depth of the first narrow portion and the second narrow portion, such that a portion of the syringe contained in the first cavity, the second cavity and the third cavity is suspended above and off the bottom.

2. The package as described in claim 1, wherein the syringe includes a syringe barrel, a flange coupled to a proximal portion of the syringe barrel, a protective member coupled to a distal portion of the syringe barrel, and a plunger rod extending through the flange and the syringe barrel; and wherein a first cavity is configured to receive the plunger rod, the flange, and the proximal portion of the syringe barrel, a second cavity is configured to receive an intermediate portion of the syringe barrel, and a third cavity is configured to receive the distal portion of the syringe barrel and the protective member.

3. The package as described in claim 2, wherein the first narrow portion and the second narrow portion are configured to engage with the intermediate portion of the syringe, thereby separating the proximal portion of the syringe housed in the first cavity, the intermediate portion housed in the second cavity, and the distal portion housed in the third cavity from the bottom.

4. The packaging as described in claim 2, wherein the syringe is pre-filled with a drug volume equal to or less than 1 mL.

5. Encapsulation as described in request item 4, wherein, The drug contains ranibizumab.

6. The encapsulation as described in claim 1 further includes: Lips The lip surrounds the opening of the disc, and includes a first portion extending around the periphery of the opening and a second portion extending from the first portion, wherein the first portion of the lip includes an adhesive, while the second portion of the lip does not contain the adhesive.

7. The encapsulation as described in claim 6 further includes: A removable cap is attached to the first portion of the lip via the adhesive to enclose the syringe within the cavity, wherein the removable cap is positioned above the second portion of the lip such that the removable cap is not attached to the second portion.

8. The package as described in claim 1, wherein the bottom is configured to abut against the portion of the syringe received in the first narrow portion and the second narrow portion to inhibit lateral and radial movement of the syringe relative to the cavity.

9. The package as described in claim 8, wherein the disc is configured to form a frictional engagement with the syringe in response to abutting the bottom against the syringe within the first narrow portion and the second narrow portion.

10. The package as described in claim 1, wherein the first narrow portion and the second narrow portion each include opposing sidewalls configured to abut against the outer surface of the syringe received in the first narrow portion and the second narrow portion.

11. The package as described in claim 10, wherein the disk includes geometric features positioned along the respective opposing sidewalls of the first narrow portion and the second narrow portion.

12. The package as described in claim 11, wherein the geometric feature extends outward from the opposing sidewalls and inwardly toward the syringe received in the first narrow portion and the second narrow portion, thereby abutting against the syringe, such that the syringe is disposed between the opposing sidewalls and below the geometric feature in each of the first narrow portion and the second narrow portion.

13. The package as described in claim 1, wherein the syringe is a pre-filled syringe.

14. The packaging as described in claim 1, wherein the syringe is a sterile syringe.

15. A package for a syringe, characterized in that it comprises: A disc having a cavity for receiving the syringe, the disc including an opening, multiple sidewalls and a bottom, wherein the cavity includes a first cavity portion, a second cavity portion and a third cavity portion; a lip surrounding the opening; and a removable cap attached to a portion of the lip; wherein at least one of the first cavity portion, the second cavity portion and the third cavity portion is connected to the other of the first cavity portion, the second cavity portion and the third cavity portion by means of a narrow portion, the narrow portion including a first sidewall, a second sidewall relative to the first sidewall and a bottom disposed between the first sidewall and the second sidewall.

16. The package as described in claim 15, wherein the first sidewall, the second sidewall, and the bottom each include at least one geometric feature protruding into the narrow portion.

17. The package as described in claim 15, wherein the syringe is prefilled with aflibercept, ranibizumab, bevacizumab, conbercept, OPT-302, RTH258 (brolucizumab), PEGylated ankylosing repeat protein (DARPin), or RG7716.

18. The package as described in claim 15 further includes a protrusion associated with the bottom of the disc, wherein the protrusion is dome-shaped and has a diameter greater than the outer diameter of the syringe barrel.

19. The package as described in claim 15 further includes a dome-shaped protrusion having a diameter, wherein the diameter is the widest portion of the dome-shaped protrusion at the junction of the dome-shaped protrusion and the bottom of the disk.

20. The package as described in claim 15 further includes a protrusion associated with the disc, the protrusion being positioned in alignment with a portion of the syringe.

21. The package as described in claim 15 further includes a protrusion associated with the cavity, wherein the protrusion may be configured to deform.

22. The package as described in claim 15 further includes a protrusion extending away from the bottom of the disk in a direction opposite to the opening, wherein the protrusion is hollow and opens toward the cavity.

23. The package as described in claim 15 further includes a protrusion that can be configured to move relative to the cavity.

24. The package as described in claim 15 further includes a protrusion, wherein the height of the protrusion from its apex to its base is greater than the distance between the base of the protrusion and a portion of the syringe contained within the cavity and covering the protrusion.

25. The package as described in claim 15, wherein the removable cover seals the opening of the disc opposite the bottom.

26. The package as described in claim 15, wherein the removable cap is permeable to a gaseous sterilizing agent constituting a sterile barrier.

27. The package as described in claim 15, wherein the syringe is a pre-filled syringe.

28. The package as described in claim 15, wherein the syringe is a sterile syringe.

29. A package for a syringe, characterized in that it comprises: A disc having a cavity for receiving the syringe, wherein the disc includes an opening, multiple sidewalls, and a bottom, wherein the cavity includes a first cavity portion, a second cavity portion, and a third cavity portion; a lip surrounding the opening; and a removable cap attached to a portion of the lip; wherein at least one of the first cavity portion, the second cavity portion, and the third cavity portion is connected to the other of the first cavity portion, the second cavity portion, or the third cavity portion by a narrow portion, wherein the narrow portion includes a first sidewall, a second sidewall, and a bottom; and wherein each of the first sidewall, the second sidewall, and the bottom includes at least one geometric feature protruding into the narrow portion.

30. The package as described in claim 29, wherein the syringe includes a plunger rod, a flange, and a syringe pre-filled with less than 1 mL of drug.

31. The package as described in claim 29, wherein the at least one geometric feature is configured to position the syringe away from at least one of the first sidewall, the second sidewall, and the bottom.

32. The package as described in claim 29, wherein the at least one geometric feature is configured to retain the syringe in the cavity via a frictional fit.

33. The package as described in claim 29 further includes a protrusion associated with the second cavity portion and extending away from the second cavity portion in a direction opposite to the opening of the cavity.

34. The package as described in claim 29 further includes a protrusion associated with the second cavity portion and extending away from the second cavity portion in a direction opposite to the opening of the cavity, wherein the protrusion is dome-shaped and includes an indicator.

35. The package as described in claim 29, wherein the first cavity portion houses the plunger of the syringe, the second cavity portion houses the syringe barrel, and the third cavity portion houses the protective element of the syringe.

36. The package as described in claim 29, wherein the disk is formed of a material comprising one or more of the following: polypropylene, polystyrene, polyethylene, polycarbonate, polyvinyl chloride, or polyethylene terephthalate.

37. The package as described in claim 29, wherein the removable cap is permeable to gaseous sterilizing agents.

38. The encapsulation as described in request item 29, wherein, In a first state, the geometric feature abuts against a portion of the syringe, while in a second state, the geometric feature is spaced apart from the syringe to release the syringe from the disc.

39. The package as described in claim 29, wherein the syringe is a pre-filled syringe.

40. The packaging as described in claim 29, wherein the syringe is a sterile syringe.

41. A package for a syringe, characterized in that it comprises: A flexible disc having a cavity for receiving the syringe, wherein the flexible disc includes an opening, one or more sidewalls, and a bottom, the cavity including a first cavity portion having a first bottom portion and a second cavity portion having a second bottom portion, wherein a first height measured from the opening to the first bottom portion is greater than a second height measured from the opening to the second bottom portion; a lip surrounding the opening, wherein the lip extends radially outward from the cavity and defines a periphery of the disc; and a removable cap having a periphery attached to the lip, wherein the removable cap is permeable to a gaseous sterilizing agent constituting a sterile barrier.

42. The package as described in claim 41, wherein the cavity further comprises a third cavity portion; and wherein the first cavity portion, the second cavity portion and the third cavity portion are arranged sequentially along the longitudinal axis of the disk and connected to each other via a narrow portion.

43. The package as described in claim 42, wherein the narrow portion includes one or more geometric features protruding into the narrow portion to position the syringe away from one or more sidewalls.

44. The package as described in claim 41, wherein the disc includes at least two geometric features located on at least one of the one or more sidewalls to retain the syringe within the cavity by frictional engagement.

45. The package as described in claim 44, wherein the disk includes a third geometric feature located at the bottom of the cavity and relatively below the syringe contained within the cavity.

46. ​​The encapsulation as described in claim 41, further comprising a protrusion associated with the bottom of the disk; and wherein, When the syringe is contained within the cavity, the height of the protrusion from its apex to its bottom is greater than the distance between the bottom of the protrusion and a portion of the syringe covering the protrusion.

47. The package as described in claim 41, wherein the syringe is a pre-filled syringe.

48. The package as described in claim 41, wherein the syringe is a sterile syringe.

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