Packaging and related methods

Abstract

To provide a novel package.SOLUTION: Wherein the packaging comprises a flexible tray having a cavity for accommodating the syringe, the tray comprising an opening, one or more side walls and a base, wherein the cavity comprises a first cavity portion, a second cavity portion and a third cavity portion, wherein at least one of the first, second and third cavity portions is connected to another of the first, second or third cavity portions by a narrowed portion; The narrowed portion comprises a flexible tray including at least one geometric feature projecting into the narrowed portion, a lip surrounding the opening, the lip extending radially outward from the cavity and defining a perimeter of the tray, a removable cover having a peripheral edge adhered to the lip, the removable cover being permeable to a gaseous sterilant configured to maintain a sterile barrier, and a dome-shaped projection continuous with the base and extending away from the base in a direction opposite the opening.SELECTED DRAWING: Figure 4

Description

[Technical Field]

[0001] Various embodiments of the present disclosure relate to packaging for medical devices. Specifically, embodiments of the present disclosure relate to blister packaging having a protrusion, e.g., a dome-shaped portion, a bulbous portion, or a raised portion, that is connected to the base of the packaging and extends away from the device when the device is placed within the blister packaging. The protrusion can be used to eject the device from the blister packaging. Specifically, the protrusion can be used to flex the blister packaging to remove a syringe, e.g., a pre-filled syringe, from the blister packaging. [Background technology]

[0002] Many medical devices are packaged for distribution and storage to or from a medical facility, for example. When a healthcare provider is ready to use the medical device, they remove it from the packaging and prepare it for use on a patient, as needed. To remove the medical device from its packaging, a user often must directly handle the device, using their hands to push, pull, lift, slide, or otherwise directly touch the medical device. In some cases, excessive handling of medical devices when removing them from their packaging may be undesirable, for example, for sterility reasons or to prevent damage to the medical device. For example, syringes, particularly pre-filled syringes, may become contaminated when handled during packaging removal, potentially compromising the sterility of the syringe body, needle, needle attachment, and / or any medication or other fluid contained therein. When the prefilled syringe is an ophthalmic syringe, handling during removal from the packaging can lead to contamination of the syringe and / or medication, which can lead to infectious eye inflammation, e.g., intraocular infections such as post-injection endophthalmitis. Furthermore, in the case of prefilled syringes, handling of the syringe can compromise dose accuracy, for example, if the syringe plunger is bumped during removal from the packaging. For ophthalmic syringes, dose accuracy can be even more critical because the dose size can be relatively small, e.g., 20 ml or less, 15 ml or less, 10 ml or less, 0.5 ml or less, or 1 ml or less. For example, the dose volume can be 200 μl or less, 150 μl or less, or 100 μl or less. Therefore, there is a need for medical device packaging that reduces the amount of direct handling of medical devices, particularly prefilled ophthalmic syringes, during removal from the packaging. Summary of the Invention

[0003] According to one aspect of the present disclosure, packaging for sterile syringes having a nominal size of less than 1 mL may include a tray having a cavity for receiving the syringe. The cavity may include an opening, one or more sidewalls, and a base. A lip may surround the opening, extend radially outward from the cavity, and define a perimeter of the tray. A removable cover may have a perimeter adhered to the lip, and the removable cover may be permeable to gaseous sterilants, including one or more of vaporized hydrogen peroxide or ethylene oxide. A protrusion may be continuous with the base of the cavity or may extend away from the base of the cavity in a direction opposite the opening of the cavity. The protrusion may be made of a deformable material.

[0004] Various embodiments of the packaging may include one or more of the following features: the protrusion may be dome-shaped and the diameter of the base of the dome-shaped protrusion may be about 10 mm to 20 mm; the cavity may include three cavity portions arranged in series along the longitudinal axis of the tray, and the three cavity portions may be connected to each other via a narrowed portion; the protrusion may be continuous with a middle cavity portion of the three cavity portions; the tray may be formed from a suitable thermoplastic material including one or more of polypropylene, polystyrene, polyethylene, polycarbonate, polyvinyl chloride, or polyethylene terephthalate glycol; When a sterile syringe is to be accommodated within the cavity, the height of the protrusion from the apex of the protrusion to the base of the protrusion may be approximately 5 mm to 6 mm, and the distance between the base of the protrusion and the portion of the syringe covering the protrusion may be approximately 3 mm to 4 mm; the sterile syringe may be a pre-filled syringe; the tray may include at least two geometric features located on at least one side wall of the packaging to hold the syringe within the cavity by friction fit, or the tray may include a third geometric feature located at the base of the cavity below where the sterile syringe will be accommodated within the cavity.

[0005] In another aspect, the present disclosure includes a package comprising a tray having an opening and a cavity, the cavity including a plurality of sidewalls and a base. A sterile syringe may be housed within the cavity, and the sterile syringe may be pre-filled with a medication. A bulbous protrusion may be connected to the tray at a position along a portion of the sterile syringe. In a first state, the bulbous protrusion may extend away from the sterile syringe in a direction opposite the opening of the cavity, and in a second state, the bulbous protrusion may be inverted such that a portion of the bulbous protrusion extends along the bulbous protrusion toward the portion of the sterile syringe. The bulbous protrusion may be configured to transition from the first state to the second state when pressure is applied.

[0006] Various embodiments of the packaging may include one or more of the following aspects: the bulbous protrusion may be under the barrel of the sterile syringe when in the first state, the cavity may include three cavity portions, with a first cavity portion accommodating the plunger of the sterile syringe, a second cavity portion accommodating the barrel of the sterile syringe, and a third cavity portion accommodating the distal portion of the sterile syringe, the three cavity portions may be connected to one another by an intermediate narrowed portion through which the sterile syringe may extend, the narrowed portion retaining the sterile syringe within the cavity by a friction fit. the packaging may include a removable cover sealing the opening of the cavity opposite the base, the removable cover may be permeable to the gaseous sterilant and configured to maintain a sterile barrier; or the agent may be any one of aflibercept, ranibizumab, bevacizumab, conbercept, OPT-302, RTH258 (brolucizumab), a PEGylated designed ankyrin repeating protein (DARPin), or RG7716.

[0007] In another aspect, the present disclosure relates to a method for removing an external sterilized syringe from a package. The method may include peeling a removable cover from a blister pack tray having a cavity configured to receive the external sterilized syringe, the blister pack tray including a dome-shaped protrusion that connects to a base of the cavity in the blister pack tray and is aligned with the external sterilized syringe. The method may further include pushing a portion of the dome-shaped protrusion toward the cavity in the blister pack tray, where pushing the portion of the dome-shaped protrusion bends the portion of the blister pack tray. The method may also include orienting the blister pack tray so that the opening of the cavity faces a sterile surface to eject the external sterilized syringe from the blister pack tray onto the sterile surface.

[0008] Various embodiments of this method may include one or more of the following aspects: the external sterilized syringe may be pre-filled with aflibercept, ranibizumab, bevacizumab, conbercept, OTP-302, RTH258 (brolocizumab), PEGylated designed ankyrin repeat protein (DARPin), or RG7716, the blister packaging tray may be manufactured from a material including one or more of polypropylene, polystyrene, polyethylene, polycarbonate, polyvinyl chloride, or polyethylene terephthalate glycol, the removable cover may be permeable to the gaseous sterilant, and the gaseous sterilant may be vaporized hydrogen peroxide or ethylene oxide.

[0009] In another aspect, the present disclosure relates to a method of removing an external sterilized syringe from a package, the package including a tray having a cavity, a deformable protrusion communicating with the cavity, and an opening covered with a gas permeable material. The method may include removing the gas permeable material to expose the opening in the tray, deforming the protrusion into the cavity and toward the barrel of the external sterilized syringe, where deforming the protrusion also bends a portion of the tray, and ejecting the external sterilized syringe from the tray.

[0010] Various embodiments of this method may include one or more of the following aspects: ejecting the externally sterilized syringe from the tray may occur without the user directly handling the syringe, the gas permeable material may be permeable to vaporized hydrogen peroxide or ethylene oxide, the deformable protrusion may include a bulbous shape, or the externally sterilized syringe may be pre-filled with aflibercept, ranibizumab, bevacizumab, conbercept, OPT-302, RTH258 (brolocizumab), a PEGylated designed ankyrin repeat protein (DARPin), or RG7716.

[0011] In another aspect, the present disclosure relates to a method of removing an externally sterilized syringe from a package, the package including a tray having a cavity and an opening covered with a gas permeable material. The method may include removing the gas permeable material to expose the opening in the tray, deforming a portion of the cavity toward the barrel of the externally sterilized syringe such that the portion of the tray flexes, and ejecting the externally sterilized syringe from the tray.

[0012] Various embodiments of this method may include one or more of the following aspects: ejecting the external sterilized syringe from the tray may occur without a user touching the external sterilized syringe with bare hands, the gas permeable material may be permeable to one or more of vaporized hydrogen peroxide or ethylene oxide, or the external sterilized syringe may be pre-filled with aflibercept, ranibizumab, bevacizumab, conbercept, OPT-302, RTH258 (brolocizumab), a PEGylated engineered ankyrin repeat protein (DARPin), or RG7716.

[0013] 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 various aspects of the present disclosure, and where appropriate, reference numerals indicating like structures, components, materials, and / or elements in different figures are similarly labeled. It is understood that various combinations of structures, components, and / or elements other than those specifically shown are contemplated and within the scope of the present disclosure.

[0014] There are many inventions described and illustrated herein. The described inventions are not limited to a single aspect or embodiment thereof, or any combination and permutation of such aspects and / or embodiments. Furthermore, each aspect and / or embodiment of a described invention may be used alone or in combination with one or more of the other aspects of the described aspect and / or embodiment. For the sake of brevity, certain permutations and combinations are not separately discussed and / or illustrated herein. In particular, an embodiment or implementation described herein as "exemplary" should not be construed as preferred or advantageous over other embodiments or implementations, for example; rather, it is intended to reflect or indicate that the embodiment is an "exemplary" embodiment. [Brief explanation of the drawings]

[0015] [Figure 1] 1 provides a perspective view of an exemplary package according to one embodiment of the present disclosure. [Figure 2] 1 provides a bottom view of an exemplary package containing a syringe, according to one embodiment of the present disclosure. [Figure 3A] 3 provides a cross-sectional view of the packaging of FIG. 2 containing a syringe according to one embodiment of the present disclosure. [Figure 3B] 3 provides a cross-sectional view of the packaging of FIG. 2 containing a partially expelled syringe while in a bent configuration, according to one embodiment of the present disclosure. [Figure 4] 1 provides a top view of an exemplary package according to one embodiment of the present disclosure. [Figure 5] 1 provides a perspective view of an exemplary package according to one embodiment of the present disclosure. [Figure 6] 1 provides a bottom view of an exemplary package containing a syringe, according to one embodiment of the present disclosure. [Figure 7] 1 provides a perspective view of an exemplary package according to one embodiment of the present disclosure. [Figure 8] 1 provides a bottom view of an exemplary package containing a syringe, according to one embodiment of the present disclosure. [Figure 9] FIG. 1 provides a bottom view of an exemplary package containing a printed syringe, according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0016] As used herein, the terms "comprises," "comprising," "includes," "including," or any other variation thereof, are intended to include a non-exclusive inclusion, such that a process, method, article, or apparatus containing a list of elements may include not only those elements, but also other elements not expressly listed or inherent in the process, method, article, or apparatus. The term "exemplary" is used in the sense of "example" rather than "ideal." Furthermore, the terms "first," "second," etc. are used herein to distinguish one element or structure from another, but do not denote any order, quantity, or importance. Furthermore, the terms "(a)" and "(an)" are used herein to indicate the presence of one or more of the referenced item, but do not denote a limitation of quantity.

[0017] The term "distal end," or any variation thereof, refers to the portion of a device that is farthest from the operator of the device during an injection operation. For example, the distal end of a syringe would be the needle end of the syringe. Conversely, the term "proximal end," or any variation thereof, refers to the portion of a device that is closest to the operator of the device during an injection operation. For example, the proximal end of a syringe would be the plunger end of the syringe. Additionally, as used herein, the terms "about," "substantially," and "nearly" typically mean + / - 10% of the indicated value.

[0018] As used in this disclosure, the term "sterilization" refers to achieving an appropriate level of sterility for a formulated drug substance or drug product for commercial distribution and use. Such a level of sterility may be defined by regulatory guidelines or regulations, such as those issued by the US Food and Drug Administration. In some embodiments, such a level of sterility may include, for example, a 6-log reduction in the microbial population of a biological indicator located on the exterior or interior surface of a pharmaceutical product (e.g., the exterior surface of a syringe or the interior 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 population of a biological indicator. Sterilization refers to achieving such an appropriate level of sterilization while also achieving sufficiently low levels of residual sterilizing chemicals (e.g., vaporized hydrogen peroxide, ethylene oxide, etc.) for commercial distribution and use. Such low levels of residual sterilizing chemicals may also be defined by regulatory guidelines or regulations.

[0019] As used in this disclosure, the term "external sterilization" refers to sterilization of a drug delivery device in a container or package, such as in a primary packaging component, or both a primary and secondary packaging component, suitable for commercial distribution and use.

[0020] Embodiments of the present disclosure relate to packaging for medical devices, particularly packaging for syringes (e.g., pre-filled syringes). In some embodiments, the packaging may be configured to accommodate an externally sterilized syringe. In particular, embodiments of the present disclosure relate to packaging for an externally sterilized, pre-filled syringe containing an ophthalmic medication. 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 International Application No. 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 protruding portions that may be inverted, pushed, and / or otherwise deformed to remove, eject, push, or otherwise move the medical device and release it from the packaging. The packaging may also be flexible to allow a user to press protrusions to bend or flex the packaging to facilitate release of the medical device contained therein.

[0021] In some exemplary embodiments, the deformable portion may include a protrusion, e.g., a dome mound or other bulbous protrusion, connected to the base of the package that is configured to position the medical device, e.g., a syringe, when the medical device is contained within the package. The protrusion may extend outward from where the medical device is configured to be located and may be accessible from the exterior of the package.

[0022] To facilitate removal of the medical device from the packaging, a user may orient the packaging so that the opening of the packaging is angled toward the surface onto which the medical device will be ejected. The user may also press the protrusion to bend the packaging, bending one or more edges of the packaging away from the medical device while bending the central portion of the packaging toward the medical device. For example, a user may press the protrusion while bending the packaging to turn the packaging sideways or upside down to eject a syringe from a tray onto a sterile surface, such as a sterile table, tray, cloth, liner, etc. Bending the packaging while the opening of the packaging is angled downward under gravity allows the medical device to be released, e.g., ejected, from the packaging onto a surface while the user only comes into contact with the packaging and not directly with the medical device.

[0023] Pressing the protrusion can also at least partially invert the protrusion. The inverted portion of the protrusion may or may not contact the medical device contained within the packaging to assist in pushing the medical device out of the packaging. In some embodiments, pressing the protrusion to bend the packaging may be sufficient to eject the device, while in other embodiments, the inverted protrusion may press against a portion of the medical device (e.g., the barrel of a syringe) to facilitate ejection of the device from the packaging. In fact, the protrusion may serve as a central landmark or target for the user to press to bend the packaging and eject the device. The protrusion may include, for example, an arrow or other visual indicator to show the user to press the packaging in a central location to bend the packaging and eject the syringe. Exemplary aspects of the packaging are described in further detail herein.

[0024] 1 shows a bottom view of exemplary packaging 100 for a medical device. Specifically, packaging 100 may be designed to house a drug delivery device such as a syringe, e.g., a pre-filled syringe. The exemplary pre-filled syringe may be used for any therapy for ocular diseases, including for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and / or diabetic retinopathy (DR). In particular, PEGylated engineered ankyrin repeat proteins (DARPins) such as aflibercept (Eylea®), ranibizumab (Lucentis®), bevacizumab (Avastin®), conbercept, OPT-302, RTH258 (brolucizumab), abicipar pegol, or large and small molecule antagonists of VEGF and / or ANG-2 such as RG7716 may be used with the exemplary syringes. Embodiments of the present disclosure may also be used in cosmetic applications or medical dermatology, such as the treatment or diagnosis of allergic reactions. Package 100 includes a tray 8 in which the syringe is housed during storage and a lip 9 extending around the periphery of tray 8 to define an opening for tray 8. The top of tray 8 (shown in FIG. 4) can be sealed with a removable cover 28 (FIG. 3A), allowing the syringe to be enclosed within tray 8 during sterilization and / or storage. In some embodiments, the package 100 may be a blister package, i.e., the package 100 may be a pre-formed plastic package, and the tray 8 may be made from a moldable web such as thermoformed plastic.

[0025] The package 100 may be suitable for use in an external sterilization process, such as a vapor hydrogen peroxide (VHP) sterilization process and / or an ethyl alcohol sterilization process. Thus, a medical device (e.g., a prefilled syringe) can be packaged within the package 100 and then subjected to external sterilization. A sterilant, such as VHP, can sterilize the exterior of the syringe without affecting the medication contained within the syringe. An exemplary sterilization process is described in International Application No. PCT / US2018 / 021013, which is incorporated herein by reference in its entirety. The material used in the package 100 may be semi-permeable to the sterilant, allowing the sterilant to penetrate part or all of the package 100 and sterilize the exterior of the medical device contained within and the interior of the package 100 once the medical device is sealed within the package 100. For example, at least 75%, at least 80%, at least 85%, at least 90%, or at least 95% of the package 100 is sterilized. For example, removable cover 28 (FIG. 3A) may be permeable to vaporized hydrogen peroxide and / or ethyl alcohol. Cover 28 may be formed, for example, of Tyvek or other suitable high-density polyethylene fabric, ethylene-vinyl acetate, and / or other thermoplastic materials. In some embodiments, tray 8 may include an indicator to allow a user to determine whether tray 8 and its contents have been sterilized. For example, tray 8 may include an indicator (e.g., tape or label) that changes color or pattern appearance to visually indicate whether the sterilization process has occurred.

[0026] As described herein, designing package 100 to be used in an external sterilization process and to allow a user to remove the contents of package 100 without directly handling the contents reduces the likelihood of compromising the sterility of the contained medical device. As a result, as described herein, package 100 can also reduce the likelihood of a person using the medical device becoming infected by the medical device. For example, if package 100 contains ophthalmic syringes, package 100 can reduce the risk of a person contracting an eye infection, such as post-injection endophthalmitis, as a result of a contaminated syringe.

[0027] An externally sterilized syringe may be one in which viable organisms on the surface of the syringe have been destroyed or killed, rendering them non-viable if they may have remained. The exterior surface of the syringe plunger rod, flange, rear surface of the piston, and the interior of the syringe barrel behind the syringe piston, as well as any other exterior surfaces of the syringe, may be externally sterilized. In some aspects, depyrogenation and / or other removal processes may be performed prior to external sterilization.

[0028] Tray 8 may include cavity 3 configured to accommodate a distal portion of a syringe. The distal end of the syringe may include, for example, a luer lock and / or syringe attachment to which a needle may be attached when the syringe is removed from tray 8 for use. In other embodiments, the needle may already be attached to the syringe within package 100 and may be further covered with a cap during storage within package 100. Cavity 2 may be configured to accommodate at least a portion of a syringe barrel (which may be a glass or plastic material compatible with a sterilant), and cavity 5 may be configured to include a flange and / or plunger of the syringe. Cavity 5 may be shaped to correspond to the shape of the flange and / or plunger of the syringe, as shown in FIG. 1 . For example, flange portion 6 of cavity 5 may correspond to the shape of the flange. Comparing FIGS. 1 , 5 , and 7 , the shape and / or sidewall of flange portion 6 of cavity 5 may be rounded to accommodate the flange of the syringe. Comparing Figures 2, 6 and 8, the interior region of flange portion 6 of cavity 5 may be configured to include, for example, rounded side walls to accommodate the flange of a syringe.

[0029] In some embodiments, the syringe housed within tray 8 may include a larger, e.g., wider, plunger rod or a larger portion of the plunger rod compared to a standard syringe to increase the clinician's hand stability when depressing the plunger rod, e.g., for intravitreal injections (FIGS. 7 and 8). In such embodiments, package 100 may be sized and shaped to accommodate the larger plunger rod. If the syringe housed within tray 8 includes a protective plunger stop, cover, and / or other element to prevent movement of the syringe plunger and / or dispensing of the medication within the syringe, cavity 5 may be shaped to reflect the contours of the flange and / or plunger with the protective element in place. However, in other embodiments, cavity 5 may be substantially rectangular, oval, or any other suitable shape, so long as the interior region of cavity 5 defines a space large enough to accommodate the proximal portion of the syringe and any associated protective element, if included. For example, Figures 5 and 6 show exemplary embodiments in which the longitudinal sidewalls of cavity 5 are generally planar and parallel to at least a portion of the syringe's plunger rod. Figures 7 and 8 show exemplary embodiments in which cavity 5 may include recessed portion 11 shaped to correspond to the shape of at least a portion of the flange or plunger, e.g., the shape of a protective plunger stop, cover, and / or other element to prevent movement of the syringe plunger and / or dispensing of medication within the syringe. For example, recessed portion 11 may be between the main area of ​​cavity 5 and flange portion 6. In exemplary embodiments, for example, in Figure 5, the shape of cavity 5 may be sized to facilitate high-speed manufacturing of package 100 and / or to improve material distribution in package 100.

[0030] Similarly, while in the exemplary embodiment of FIG. 1 , cavity 3 is shown as substantially rectangular and cavity 2 is shown as generally square, cavities 3 and 5 may be any suitable size and shape or shapes to accommodate the distal end of a syringe (and any cover contiguous with the distal end) and at least a portion of the syringe barrel, respectively. For example, cavities 2 and 3 may be oval, circular, trapezoidal, or wider or narrower rectangular, or any combination thereof. Cavities 2, 3, and 5 may be dimensioned to provide space between the cavity walls and the syringe to allow sterilant to circulate within package 100 during the sterilization process to sterilize the inner surface of package 100 and the outer surface of the syringe. Furthermore, tray 8 and cavities 2, 3, and 5 may have substantially flat surfaces on the top and bottom (e.g., cover 28 and base) to allow multiple packages to be stacked on top of each other during storage. Flat surfaces may also allow for consistent placement within an autoclave. That said, in some embodiments, cavity 2, cavity 3, cavity 5, and tray 8 may have rounded, e.g., cylindrical, or any other suitable shape. Additionally, tray 8 may have rounded or sharp corners and edges. In exemplary embodiments, for example, with reference to FIG. 5 , the shape and size of cavity 2, cavity 3, cavity 5, and tray 8 may be shaped and sized to facilitate high-speed production of package 100 and / or improve material distribution in package 100.

[0031] In the embodiment of Figures 1, 5, and 7, narrowed portion 7 extends between cavity 2, cavity 3, and cavity 5, fluidly connecting all three cavities. Narrowed portions 7 are sized to accommodate regions of the syringe barrel therein, allowing the syringe to extend into all three cavities when contained within package 100, as can be seen in Figures 2, 6, and 8. For example, in Figures 2, 6, and 8, as previously described, plunger flange 14 of the packaged syringe is within flange portion 6 of cavity 5, syringe barrel 12 extends within narrowed portion 7 and across cavity 2, and a distal region of the syringe, at least partially covered by guard 15 (e.g., a Luer lock), is within cavity 3.

[0032] Although tray 8 is shown as including three cavities 2, 3, and 5 extending along longitudinal axis 22 (FIGS. 2, 6, and 8) and connected to each other by narrowed portion 7, it is contemplated that tray 8 may have any suitable number of cavities. For example, one cavity of substantially equal depth may be included for holding medical instruments, two cavities may be included, or more than three cavities may be included. The cavities (in embodiments having multiple cavities) may be connected to each other so that they can combine to accommodate medical instruments. Alternatively, if multiple medical instruments or multiple components are to be accommodated in tray 8, tray 8 may include multiple cavities that are not connected to each other. In such embodiments, it is contemplated that two or more of the cavities may include protrusions to facilitate removal of medical instruments and / or components from tray 8, as described further below.

[0033] In the embodiment of FIGS. 1 and 2, cavity 2 includes a dome 4 at the bottom of package 100. Dome 4 may be a flexible, hollow protrusion in tray 8 configured to facilitate removal of the syringe from package 100. Dome 4 is contiguous to the base of cavity 2 such that dome 4 is oriented below the syringe when it is contained within package 100. In the embodiment of FIG. 2, dome 4 is aligned with the central region of syringe barrel 12. Dome 4 may be made of a compressible material that deforms under pressure, e.g., pressure applied by a user. Dome 4 may be made of the same material as the rest of tray 8, or may be made of a different, e.g., relatively flexible, material. In some embodiments, as described above, dome 4 and tray 8 may be thermoformed plastic. For example, dome 4 and / or tray 8 may be formed of polypropylene, polystyrene, polyethylene, polycarbonate, polyvinyl chloride, or polyethylene terephthalate glycol (PETG). The diameter of the base of the dome 4 (e.g., the widest part of the dome 4 where it meets the base of the tray 8) may be about 10 mm to 20 mm, e.g., about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, or about 19 mm. With reference to Figure 5, as compared to Figure 1, the diameter of the base of the dome 4 may be sized to facilitate high speed production of the package 100 and / or to improve material distribution in the package 100.

[0034] FIG. 3A shows a cross-sectional view of tray 8 containing a syringe (e.g., an empty or pre-filled syringe containing an ophthalmic medication). As described above, dome 4 projects outward from the base of tray 8, away from the syringe, when the syringe is received in tray 8, and dome 4 is aligned with syringe barrel 12 below (or above, depending on the orientation of tray 8). To remove the syringe from package 100, removable cover 28 may be removed, e.g., peeled off, tray 8 may be turned on its side or upside down so that the opening of the package faces the surface, and dome 4 may be pressed by a user. The user may press dome 4 with one or more fingers (e.g., thumb) toward the syringe contained within the package. When the user presses dome 4, the package may flex such that a 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 package 100 is flexed (FIG. 3B), this allows the syringe to be released from the package. Because package 100 is oriented with the opening gravitationally facing downward (or at least perpendicular to the surface below), the syringe can be ejected from package 100 onto the surface. Thus, by pushing dome 4 to flex package 100, a user can remove the syringe from package 100 without ever directly touching the syringe. If package 100 is held upside down, the syringe will not fall out on its own, and package 100 can hold the syringe suspended until the user flexes package 100, for example, by pushing dome 4.

[0035] When a user pushes on the dome 4 to bend the tray 8, the dome 4 deforms and can at least partially invert. The dome 4 may or may not be configured to contact the syringe barrel 12 when inverted. In some embodiments, the dome 4 may push on the syringe barrel 12 to assist in removing the syringe from the packaging 100. In such embodiments, the height of the dome 4 from the apex of the dome 4 to the base of the cavity through which the dome 4 extends may be greater than the distance from the base of the cavity to where the medical device (e.g., a syringe) is positioned within the tray 8. As used herein, the term "apex" refers to the portion of the dome 4 farthest from the base of the cavity through which the dome 4 extends, regardless of the relative orientation of the dome 4 and the tray 8. In an exemplary embodiment, a syringe may be accommodated within the tray 8 such that the height of the dome 4 from the apex of the dome 4 to the base of the tray 8 is approximately 5 mm to 6 mm, provided that the distance between the base of the tray 8 and the bottom of the syringe covering the dome 4 is approximately 3 mm to 4 mm. However, in other embodiments, dome 4 may not contact syringe barrel 12 when pressed by a user. Instead, the deflection of tray 8 caused by pressing dome 4, combined with the gravitational downward orientation of the opening in tray 8, may be sufficient to dislodge the syringe from tray 8 and cause the syringe to eject onto a surface (preferably a sterile surface).

[0036] A user can push dome 4 to bend tray 8 (i.e., orient tray 8 so that the opening faces downward or sideways) before, during, and / or after orienting tray 8 so that the opening faces downward or sideways toward the surface onto which the syringe will be ejected. Orienting tray 8 so that the opening faces the surface allows the syringe to drop from tray 8 onto a suitable sterile surface without the user having to directly handle the syringe to remove it from the packaging. Reducing the amount of handling required by the user can reduce the likelihood of the syringe and / or its contents becoming contaminated and infecting the part of the body into which the syringe contents are injected. For example, a sterile ophthalmic syringe may be contained within package 100, and dome 4 and package 100 can prevent sterility from being compromised by the user when removing the syringe, which can ultimately reduce the risk of eye infections, such as post-injection endophthalmitis, resulting from a contaminated syringe. Reducing handling of the syringe may also reduce the risk of accidentally expelling some of the medication from the syringe when the syringe is removed from the package 100.

[0037] The location of the dome 4 protrusion and / or other protruding portion on the tray 8 can facilitate syringe removal as well as guide the user on how to handle particular 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, indicia, and / or tactile features (e.g., ridges, bumps, or grooves) that indicate to the user where to press to flex the tray 8 and release the syringe from the package 100. Overall, the inclusion of the dome 4 or other suitable protrusion on the tray 8 can reduce one or more of the following possibilities: injury to the user, damage to the device, loss of sterility of the device or any agent within the device, and / or accidental release of an agent within the device.

[0038] In some embodiments, the syringe may be released from the friction-fit portion of the tray 8 by pushing on the dome 4 and / or bending or flexing the tray 8. For example, as shown in FIG. 4 , the narrowed portion 7 may include one or more geometric features 17 that protrude into the narrowed portion to retain the sterile syringe within the cavity by a friction fit. The geometric features 17 may be located on the sidewalls of the narrowed portion 7 and / or on the bottom of the narrowed portion 7 to position the syringe barrel 12 within the narrowed portion 7. The syringe may be packaged within the tray 8 so that the package 100 both facilitates sterilization, e.g., to reduce contact area with the syringe and maximize the surface area of ​​the syringe available for sterilization while still retaining and suspending the syringe within the tray 8 when turned upside down, and the syringe may be pushed into the tray 8 so that the syringe barrel 12 slides past the geometric features 17 and the syringe becomes a friction fit within the tray 8. When syringe barrel 12 is pressed into place within tray 8, geometric feature 17 can hold syringe barrel 12 within narrowed portion 7, retaining the syringe within tray 8. To release the syringe from tray 8, pushing on dome 4 can bend tray 8 and / or push syringe barrel 12 up so that it moves past geometric feature 17. For example, bending tray 8 may force the portion of tray 8 containing geometric feature 17 away from the syringe, thereby releasing the syringe. Thus, dome 4 can be used in combination with other friction-fit portions of tray 8 to facilitate release of the syringe from tray 8.

[0039] One or more geometric features 17 located at the base of narrowed portion 7 may work in conjunction with geometric features 17 on the side walls of narrowed portion 7 to orient the syringe so that it does not directly contact the side walls of narrowed portion 7 and any of the other cavities (e.g., cavity 2, cavity 3, cavity 5 when contained within package 100). This may allow sterilant within package 100 to circulate within package 100 and around the exterior surface of the syringe. By including geometric features 17 to hold the syringe in place and away from the interior surface of the package, geometric features 17 may reduce the surface area of ​​the syringe that contacts the interior walls of package 100, thereby increasing the surface area of ​​the syringe exposed to the sterilant within package 100.

[0040] 4, it is contemplated that each narrowed portion 7 may include fewer (e.g., two) or more than three geometric features 17. Furthermore, geometric features 17 may be included in any suitable portion of tray 8, including any combination of cavities, instead of or in addition to a narrower portion such as narrowed portion 7.

[0041] Although reference is made herein to a dome-shaped portion, it should be understood by those skilled in the art that the protrusion on tray 8 may have any suitable shape so long as it can be pressed to bend tray 8 and / or compress into an inverted position. Furthermore, while tray 8 is depicted as including three cavities 2, 3, and 5 connected to each other by narrowed portion 7, it is contemplated that tray 8 may have any suitable shape with one or more cavities for housing a medical device. For example, while embodiments of the present disclosure relate to packaging for syringes, e.g., pre-filled syringes, it should be understood that protrusions such as dome 4 may be used in conjunction with packaging for any suitable medical device and / or consumer goods. Accordingly, tray 8 may be shaped to house other types of medical devices. Additionally, multiple protrusions, e.g., multiple domes 4, may be incorporated into tray 8 to facilitate removal of medical devices therein.

[0042] As discussed above, the use of dome 4 on packaging (e.g., blister packs) to release a syringe contained within the packaging can reduce the amount of direct contact a user needs to have with the syringe before administering the contents of the syringe to a person, thereby increasing syringe and user sterility, dose accuracy, and / or safety, which in turn can reduce the risk of accidentally expelling the contents of the syringe before administering the medication to a person and can reduce the incidence of human infection.

[0043] 1 and 2 , the package 100 may also include a lip 9 extending around at least a portion of the tray 8 to define an opening for the tray 8. The lip 9 may allow a removable (e.g., peelable) cover 28 to be sealed over the top opening of the tray 8 to accommodate a medical device within the tray 8 during storage. An adhesive 18, such as glue, paste, film, tape, a pressure-sensitive material, and / or a cold adhesive, may be used to seal the removable cover 28 to the lip 9. The adhesive 18 may be compatible for use 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 tray 8; for example, increasing the size of the top opening of the tray 8 reduces the width of the adhesive 18. A corner of the lip 9, such as corner 16 in FIG. 2 , may be free of adhesive 18, allowing a user to lift the removable cover 28 from the corner 16 to remove the cover from the tray 8. 6 and 8, corner 16 may include tab 20 (or other protrusion or indentation) that allows a user to lift removable cover 28 from corner 16 to remove cover 28 from tray 8. Tab 20 may be included on corner 16 of lip 9 or on removable cover 28. In an exemplary embodiment, with reference to FIGS. 2 and 6, the type, shape, and / or size of lip 9 or tab 20 (or other protrusion or indentation) may be configured to facilitate high-speed manufacturing of package 100 and / or improve material distribution in package 100. Removable cover 28 may be made of any suitable material, e.g., foil paper, plastic, etc., and may be permeable to a suitable gaseous sterilant, such as vaporized hydrogen peroxide or ethyl alcohol.

[0044] During use, a user can first remove the removable cover 28 from the tray 8 (e.g., by peeling the cover 28 from the lip 9) to expose the opening of the tray 8. The user can then orient the opening of the tray 8 sideways or upside down so that the opening faces the surface onto which the medical device (e.g., a pre-filled ophthalmic syringe) will be ejected. Subsequently or simultaneously, the user can press the dome 4 (or other protrusion), which can bend the tray 8 so that one or more edges of the package bend away from the medical device while the central portion of the package bends toward the medical device. Pressing the dome 4 can at least partially invert the dome 4. In some embodiments, the inverted 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. Thus, by pressing the dome 4 and bending the tray 8, the medical device can be ejected from the tray 8 so that it lands on the surface toward which the opening of the tray 8 is oriented. Suitable sterile surfaces may include, for example, a sterile table, a tray for holding medical instruments, a cloth, a liner, or any other suitable sterile surface. A combination of pressing dome 4, inverting dome 4, bending tray 8, and / or turning tray 8 on its side or upside down so that the base of tray 8 is oriented above the syringe and above the sterile surface allows the user to remove the syringe without actually touching it directly.

[0045] In some embodiments, pushing on the dome 4 may cause the tray 8 to flex, thereby releasing the medical device from a friction-fit portion of the tray 8, e.g., one or more geometric features 17. Once the syringe is released from the tray 8 (e.g., via flipping and / or bending of the dome 4), the tray 8 may be reoriented to allow the syringe to fall out of the tray 8. In embodiments including multiple domes 4 (or multiple other protrusions), multiple domes 4 may be pushed to release the medical device from the tray 8 and flex different portions of the tray 8, or to either release the medical device from the tray 8 or flex different portions of the tray 8.

[0046] In the case of pre-filled syringe packaging, any additional packaging on the syringe (e.g., a distal guard or luer lock and / or plunger guard) may be removed from the syringe once the syringe is released from tray 8. In some embodiments, the syringe may be contained in package 100 without a needle, and a needle, e.g., a stake needle, may be attached to the distal end of the syringe, e.g., via a needle attachment. The contents of the syringe (e.g., aflibercept (Eylea®), ranibizumab (Lucentis®), bevacizumab (Avastin®), conbercept, OPT-302, RTH258 (brolucizumab), a PEGylated engineered ankyrin repeat protein (DARPin) such as abicipar pegol, or a large and / or small molecule antagonist of VEGF and / or ANG-2 such as RG7716) may then be injected into the subject's eye.

[0047] As previously mentioned, the components of package 100, and the size and / or shape of such components, may be configured to facilitate high speed manufacturing of package 100 and / or to improve material distribution of package 100. Figure 9 is an exemplary embodiment showing a portion of the manufacturing process for package 100, in which, for example, packages 101a, 101b, and 101c are sealed with material 30 to form removable cover 28 (Figure 3), which may be, for example, Tyvek or other suitable high density polyethylene fiber, ethylene vinyl acetate, and / or other thermoplastic material.

[0048] The above description and examples are illustrative, not limiting. Numerous modifications and variations or alterations may be made by those skilled in the art without departing from the overall scope of the invention. For example, and as referenced, the above-described embodiments (and / or aspects thereof) may be used in combination with each other. In addition, portions of the above-described embodiments may be removed without departing from the scope of the invention. Furthermore, modifications may be made to adapt a particular situation or aspect to the teachings of the various embodiments without departing from the scope of such situation or aspect. Many other embodiments will be apparent to those skilled in the art upon reviewing the above description.

Claims

1. Packaging, a flexible tray having a cavity for accommodating a syringe, the flexible tray including an opening, one or more sidewalls, and a base, the cavity including a first cavity portion, a second cavity portion, and a third cavity portion, at least one of the first, second, and third cavity portions being connected to another of the first, second, or third cavity portions by a narrowed portion, the narrowed portion including at least one geometric feature protruding into the narrowed portion; a lip surrounding the opening, the lip extending radially outward from the cavity and defining a perimeter of the flexible tray; a removable cover having a peripheral edge adhered to the lip, the removable cover being permeable to a gaseous sterilant configured to maintain a sterility barrier; a dome-shaped protrusion connected to the base and extending away from the base in a direction opposite to the opening; Packaging provided.

2. The package of claim 1 , wherein the at least one geometric feature is configured to position the syringe away from the one or more side walls.

3. The package of claim 1 , wherein the at least one geometric feature retains the syringe within the cavity by a friction fit.

4. 10. The package of claim 1, wherein the narrowed portion includes at least one sidewall, and the at least one geometric feature is located on the sidewall of the narrowed portion.

5. The package of claim 1 , wherein the narrowed portion includes a base, and the at least one geometric feature is located on the base of the narrowed portion.

6. 10. The package of claim 1, wherein the narrowed portion includes at least two geometric features located on at least one of the one or more side walls of the package to retain the syringe within the cavity by a friction fit.

7. 10. The package of claim 1, wherein the narrowed portion includes at least three geometric features, at least one of which is located on the base below where the syringe is received within the cavity.

8. The package of claim 1 , wherein the dome-shaped protrusion is continuous with the second cavity portion of the flexible tray.

9. The package of claim 8 , wherein the dome-shaped protrusion includes an indicator.

10. 9. The package of claim 8, wherein the diameter of the base of the dome-shaped protrusion is about 10 mm to 20 mm.

11. 9. The package of claim 8, wherein when the syringe is housed within the cavity, a height of the dome-shaped protrusion from an apex of the dome-shaped protrusion to a base of the dome-shaped protrusion is about 5 mm to about 6 mm, and a distance between the base of the dome-shaped protrusion and a portion of the syringe covering the dome-shaped protrusion is about 3 mm to about 4 mm.

12. 10. The package of claim 1, wherein the flexible tray is formed from a material including one or more of polypropylene, polystyrene, polyethylene, polycarbonate, polyvinyl chloride, or polyethylene terephthalate glycol.

13. 10. The package of claim 1, wherein the syringe is pre-filled with aflibercept, ranibizumab, bevacizumab, conbercept, OPT-302, RTH258 (brolucizumab), PEGylated designed ankyrin repeat proteins (DARPins), or RG7716.

14. 10. The package of claim 1, wherein the syringe is a pre-filled syringe containing aflibercept.

15. 10. The package of claim 1, wherein the gaseous sterilant is vaporized hydrogen peroxide or ethylene oxide.

16. 10. The package of claim 1, wherein the removable cover is formed from high density polyethylene fibers, ethylene vinyl acetate, a thermoplastic material, or a combination thereof.

17. 1. A method of sterilizing a package, the package comprising: a flexible tray having a cavity for accommodating a syringe, an opening, one or more sidewalls, and a base, the cavity including a first cavity portion, a second cavity portion, and a third cavity portion, at least one of the first cavity portion, the second cavity portion, and the third cavity portion being connected to another of the first cavity portion, the second cavity portion, or the third cavity portion by a narrowed portion, the narrowed portion including at least one geometric feature protruding into the narrowed portion; a lip extending radially outward from the cavity to surround the opening and define a perimeter of the flexible tray; a removable cover having a peripheral edge adhered to the lip, the removable cover being permeable to a gaseous sterilant configured to maintain a sterility barrier; a dome-shaped protrusion connected to the base and extending away from the base in a direction opposite to the opening; Equipped with The method comprises: inserting the syringe into the flexible tray, the first cavity portion including a plunger of the syringe, the second cavity portion including a barrel of the syringe, and the third cavity portion including a needle attachment portion of the syringe; covering the flexible tray with the removable cover; sterilizing the packaging containing the syringe with the gaseous sterilant; A method comprising:

18. 18. The method of claim 17, wherein the removable cover is permeable to vaporized hydrogen peroxide or ethylene oxide.

19. 18. The method of claim 17, wherein the syringe is sterilized during a sterilization process.

20. 18. The method of claim 17, wherein the removable cover is formed from high density polyethylene fibers, ethylene vinyl acetate, a thermoplastic material, or a combination thereof.

21. 18. The method of claim 17, wherein the syringe is pre-filled with aflibercept, ranibizumab, bevacizumab, conbercept, OPT-302, RTH258 (brolucizumab), PEGylated engineered ankyrin repeat proteins (DARPins), or RG7716.

22. 18. The method of claim 17, wherein the syringe is a pre-filled syringe containing aflibercept.

23. 18. The method of claim 17, further comprising removing the syringe from the packaging after a sterilization step.

24. 24. The method of claim 23, wherein removing the syringe from the packaging comprises: removing the removable cover to expose the opening in the flexible tray; pressing a portion of the flexible tray to bend the portion of the flexible tray; ejecting the syringe from the flexible tray; A method comprising:

25. 25. The method of claim 24, wherein ejecting the syringe from the flexible tray occurs without direct handling of the syringe by a user.

Images