Medical Device Packages and Related Methods

Abstract

The package includes a tray having an opening, a cavity including at least three cavities, a plurality of sidewalls, and a base, and a sterile syringe housed within the cavity. The sterile syringe is pre-filled with a medicament or other fluid. A first cavity includes a plunger rod of the sterile syringe, a second cavity includes a barrel of the sterile syringe, and a third cavity includes a needle attachment of the sterile syringe, the at least three cavities being connected to one another by a plurality of constrictions at intermediate locations. Each of the constrictions includes a first sidewall, a second sidewall, a base, and a plurality of geometric features that protrude into the interior of the constriction to position the sterile syringe away from the plurality of sidewalls.

Description

[Technical field]

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 306,925, filed February 4, 2022, and U.S. Provisional Patent Application No. 63 / 401,549, filed August 26, 2022, all of which are incorporated herein by reference. Various embodiments of the present disclosure relate to medical device packaging. An embodiment of the present disclosure may include a blister package for housing a drug delivery device, such as a syringe, more specifically a prefilled syringe. In some embodiments, the blister package includes a protrusion, such as a dome-shaped, bulb-shaped, mound-shaped, or other suitable shaped (e.g., rectangular) portion, associated with the base of the package to extend away from the device when the device is housed within the blister package. The protrusion may be used to remove the device from the blister package. Specifically, the protrusion may be used to bend the blister package to remove a syringe, such as a prefilled syringe, from the blister package. In embodiments without such protrusions, the blister package may have suitable flexibility to allow removal of the syringe therein. [Background technology]

[0002] Many medical devices are packaged for distribution and / or storage, for example, in medical facilities. When a medical provider is ready to use the medical device, it is removed from the package and, if necessary, prepared for use on a patient. To remove the medical device from the package, a user often needs to directly handle the device, pushing, pulling, lifting, sliding, or otherwise touching the medical device directly with their hands. In some cases, it may be undesirable to handle the medical device excessively when removing it from its package, for example, for sterility reasons or to prevent damage to the medical device. For example, syringes, particularly prefilled syringes, may become contaminated if they are handled during removal of the package, compromising the sterility of the syringe body, needle, needle attachment, and / or medication or other fluid contained therein. If the prefilled syringe is an ophthalmic syringe, handling during removal from the package may lead to contamination of the syringe and / or the drug or other fluid contained therein, leading to infectious inflammation of the eye, such as intraocular infections, such as post-injection endophthalmitis. Also, in the case of a prefilled syringe, handling of the syringe may jeopardize dose accuracy, for example, if the syringe plunger is bumped during removal from the package. For ophthalmic syringes, dose accuracy may be more important because the dose size is relatively small, for example, 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 may be 200 μl or less, 150 μl or less, or 100 μl or less. Thus, there is a need for a medical device package that reduces the amount of direct handling of the medical device, particularly the ophthalmic prefilled syringe, during removal from the package and / or provides easier removal of the medical device from the package. Summary of the Invention

[0003] According to one aspect of the present disclosure, a package includes a tray having an opening, a cavity including three cavities, a plurality of side walls, and a base; A sterile syringe housed within the cavity, the sterile syringe being pre-filled with a medication or other fluid.

[0004] A first cavity includes a plunger of the sterile syringe, a second cavity includes a barrel of the sterile syringe, and a third cavity includes a needle attachment of the sterile syringe, and the at least three cavities are connected to one another by a plurality of intermediate constrictions, each of the constrictions including a first side wall, a second side wall, a base, and a plurality of geometric features that protrude into the interior of the constriction to position the sterile syringe away from the plurality of side walls.

[0005] Various embodiments of the package may include one or more of the following aspects. The first sidewall of the constriction may include a first geometric feature. The second sidewall of the constriction may include a second geometric feature. The distance between the first geometric feature and the second geometric feature may be less than a width of a portion of the sterile syringe contained within the constriction and less than about 2.0 mm. The distance between the first geometric feature and the second geometric feature may be in the range of about 5.5 mm to about 6.5 mm. The base of the constriction may include a third geometric feature. The tray may include a protrusion associated with the tray at a location that coincides with a portion of the sterile syringe. The first cavity may include a flange portion configured to hold a flange of the syringe. A constriction recess may be located between the flange portion and the first cavity. Each of the at least three cavities may have a rectangular shape. Each of the at least three cavities may have a rectangular shape with a radius around each corner.

[0006] Another embodiment of the present disclosure describes a package for a sterile syringe. The package includes a tray having an opening, a cavity including a plurality of cavities, a plurality of side walls, and a base. The plurality of cavities are connected to one another by a plurality of intermediate constrictions, each constriction including a first side wall, a second side wall, and a base. Each of the first side wall, the second side wall, and the base includes a geometric feature that extends away from the corresponding side wall or base and projects into the constriction to position the sterile syringe away from the plurality of side walls. The package includes an edge surrounding the opening, the edge extending radially outward from the cavity to define a periphery of the tray, and a removable cover having a periphery bonded to the edge, the removable cover being permeable to a gaseous sterilant.

[0007] Various embodiments of the package may include one or more of the following aspects: The geometric feature on the first sidewall may be a first geometric feature. The geometric feature on the second sidewall may be a second geometric feature. The distance between the first geometric feature and the second geometric feature may range from about 5.5 mm to about 6.5 mm. The plurality of cavities may include three cavities. A first cavity may include a plunger of the sterile syringe. A second cavity may include a barrel of the sterile syringe. A third cavity may include a needle attachment of the sterile syringe. The gaseous sterilant is one or more of vaporized hydrogen peroxide, ethylene oxide, or nitrous oxide.

[0008] Another embodiment of the present disclosure describes a method of removing an external sterile syringe from a package, the package including a tray having a cavity, a plurality of geometric features associated with the cavity, and a removable cover, the method including removing the removable cover to expose an opening of the tray, grasping a portion of the external sterile syringe held by the plurality of geometric features, and removing the external sterile syringe from the tray, the method including moving the plurality of geometric features away from the external sterile syringe to release the external sterile syringe from the tray.

[0009] Various embodiments of the method of removing the external sterile syringe from the package may include one or more of the following aspects: The external sterile syringe may be pre-filled with aflibercept, ranibizumab, bevacizumab, conbercept, OPT-302, RTH258 (brolucizumab), pegylated designed ankyrin repeat protein (DARPin), or RG7716. The 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 a gaseous sterilant. The gaseous sterilant may be hydrogen peroxide vapor. The method includes pushing a portion of the package forward of a cavity in the tray. Pushing the portion of the package may deflect a portion of the tray. Pushing the portion of the tray may release the external sterile syringe from the plurality of geometric features. The portion of the package that is pushed may include a deformable protrusion. The tray may be manufactured by thermoforming injection or blow molding techniques. [Brief description of the drawings]

[0010] [Figure 1] FIG. 1 is a perspective view of an exemplary package according to an embodiment of the present disclosure. [Diagram 2] FIG. 2 is a bottom view of an exemplary package containing a syringe, according to an embodiment of the present disclosure. [Figure 3A] FIG. 3A is a cross-sectional view of the package of FIG. 2 containing a syringe according to an embodiment of the present disclosure. [Figure 3B] 3B is a cross-sectional view of the package of FIG. 2 containing a syringe partially removed during a bent configuration according to an embodiment of the present disclosure. [Figure 4] FIG. 4 is a top view of an exemplary package according to an embodiment of the present disclosure. [Diagram 5] FIG. 5 is a perspective view of an exemplary package according to an embodiment of the present disclosure. [Figure 6] FIG. 6 is a bottom view of an exemplary package containing a syringe, according to an embodiment of the present disclosure. [Figure 7] FIG. 7 is a perspective view of an exemplary package according to an embodiment of the present disclosure. [Figure 8] FIG. 8 is a bottom view of an exemplary package containing a syringe, according to an embodiment of the present disclosure. [Figure 9] FIG. 9 is a bottom view of an exemplary package containing a syringe printed in accordance with an embodiment of the present disclosure. [Figure 10] FIG. 10 is a top view of an exemplary package according to an embodiment of the present disclosure. [Figure 11] FIG. 11 is a bottom view of an exemplary package according to an embodiment of the present disclosure. [Figure 12] FIG. 12 is a perspective view of an exemplary package according to an embodiment of the present disclosure. [Figure 13] FIG. 13 is a side view of an exemplary package according to an embodiment of the present disclosure, with the dashed lines identifying the cross-sectional view shown in FIG. [Figure 14] FIG. 14 is a cross-sectional view of an exemplary package according to an embodiment of the present disclosure taken along the dashed line shown in FIG. [Figure 15] FIG. 15 is a top view of an exemplary package according to one embodiment of the present disclosure. [Figure 16] FIG. 16 is a bottom view of an exemplary package according to an embodiment of the present disclosure. [Figure 17] FIG. 17 is a perspective view of an exemplary package according to an embodiment of the present disclosure. [Figure 18] FIG. 18 is a side view of an exemplary package according to an embodiment of the present disclosure, with dashed lines identifying the cross-sectional view shown in FIG. [Figure 19] 19 is a cross-sectional view of an exemplary package according to an embodiment of the present disclosure taken along the dashed line shown in FIG. 18. [Figure 20A-20B] 20A and 20B are perspective views of an exemplary package according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the following description, serve to explain the principles of the disclosed embodiments. The drawings illustrate various aspects of the disclosure, and reference characters designating similar structures, components, materials, and / or elements in different views are similarly labeled where appropriate. It is understood that various combinations of structures, components, and / or elements other than those specifically shown are contemplated and are within the scope of the present disclosure.

[0012] Although many inventions are described and illustrated herein, the described inventions are not limited to any single aspect or embodiment thereof, nor to any combinations and / or permutations of such aspects and / or embodiments. Moreover, each aspect of the described invention and / or its embodiments may be used alone or in combination with one or more of the other aspects of the described invention and / or its embodiments. For the sake of brevity, some permutations and combinations are not separately described and / or illustrated herein. It should be noted that an embodiment or implementation described herein as "exemplary" should not be construed as being preferred or advantageous over other embodiments or implementations, for example, but rather is intended to reflect or indicate that one or more embodiments are "exemplary" one or more embodiments.

[0013] As used herein, the terms "comprises," "comprising," "including," "including," or other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus comprising a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example" rather than "ideal." Additionally, terms such as "first," "second," and the like are not used herein to denote an order, quantity, or importance, but rather to distinguish one element or structure from another. Additionally, the term "a" or "an" is used herein not to denote a limitation of quantity, but rather to denote the presence of one or more of the referenced item.

[0014] The term "distal end" or variations thereof refers to the portion of the device that is furthest from an operator of the device during an injection action. For example, the distal end of a syringe is the needle end of the syringe. Conversely, the term "proximal end" or variations thereof refers to the portion of the device that is closest to an operator of the device during an injection action. For example, the proximal end of a syringe is the plunger end of the syringe. Additionally, as used herein, the terms "about," "substantially," and "approximately" generally mean + / - 10% of the indicated value.

[0015] The term "sterilization" as used in this disclosure 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 in regulatory guidelines or regulations, such as, for example, guidelines 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 population of a biological indicator located on the exterior or interior surface of a drug 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 reduction or a 12 log reduction in the microbial population of a biological indicator. Sterilization also refers to achieving such an appropriate level of sterility while simultaneously achieving a sufficiently low level 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 in regulatory guidelines or regulations.

[0016] The term "external sterilization" as used in this disclosure refers to sterilization of a drug delivery device in a container or package (e.g., a primary packaging component, or both a primary and secondary packaging component) suitable for commercial distribution and use.

[0017] The embodiments of the present disclosure relate to medical device packages, and in particular to packages for syringes (e.g., prefilled syringes). In some embodiments, the packages may be configured to accommodate an external sterile syringe. In particular, the embodiments of the present disclosure may be directed to packages for external sterile prefilled syringes containing an ophthalmic drug or other fluid (e.g., a placebo). Exemplary ophthalmic syringes may be prefilled 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 an ophthalmic drug or other fluid (e.g., a placebo). In some embodiments, the exemplary packages 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 packages may include one or more features to facilitate removal of the medical device from the packages. For example, the packages may include one or more deformable protrusions. The protrusions may be inverted, pushed, and / or otherwise deformed to remove, eject, push, or otherwise move the medical device to release it from the package. The package may also be flexible to allow a user to push the protrusions to bend or flex the package to facilitate release of the medical device contained therein. The package may also include features that allow a user to pull up and withdraw the syringe from the package while minimizing damage to the syringe or its plunger / needle and / or impact to the sterility of the syringe.

[0018] In some exemplary embodiments, the one or more deformable portions may include a protrusion, such as a dome mound or other bulbous protrusion associated with the base of the package, configured for a medical device, such as a syringe, to be placed on when the medical device is contained within the package. The protrusion may extend outwardly away from where the medical device is located and may be accessible from an exterior surface of the package. The protrusions disclosed herein may include any suitable shape, including, but not limited to, a rectangular shape.

[0019] To facilitate removal of the medical device from the package, the user may orient the package so that the opening of the package faces the surface from which the medical device is to be removed. The user may also push the protrusions to flex the package so that the center of the package flexes toward the medical device while one or more edges of the package flex away from the medical device. For example, the user may rotate the package sideways or upside down while pushing the protrusions to flex the package to expel the syringe from the tray onto a sterile surface, such as a sterile table, tray, cloth, liner, etc. Bending the package when the opening of the package faces downward in the direction of gravity allows the user to release, e.g., expel, the medical device from the package onto a surface while only touching the package and not directly touching the medical device.

[0020] Also, pressing the protrusion can at least partially invert the protrusion. The inverted portion of the protrusion may or may not contact the medical device contained within the package, helping to push the medical device out of the package. In some embodiments, pressing the protrusion to deflect the package may be sufficient to remove the device, while in other embodiments, the inverted protrusion may push a portion of the medical device (e.g., the barrel of a syringe) to facilitate removal of the device from the package. In fact, the protrusion may act as a central landmark or target for the user to press to deflect the package and remove the device. The protrusion may include, for example, an arrow or other visual identifier to suggest to the user to push the package at a central location to deflect the package and remove the syringe. Exemplary aspects of the package are described in further detail herein.

[0021] 1 shows a bottom view of an exemplary package 100 for a medical device. Specifically, the package 100 can be designed to accommodate a drug delivery device, such as a syringe, for example, a prefilled syringe. The exemplary prefilled syringe can be used with any treatment for eye disease, including the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema after retinal vein occlusion (RVO), diabetic macular edema (DME), and / or diabetic retinopathy (DR). Specifically, large and small molecule antagonists of VEGF and / or ANG-2, such as aflibercept (Eylea®), ranibizumab (Lucentis®), bevacizumab (Avastin®), conbercept, OPT-302, RTH258 (brolucizumab), pegylated designed ankyrin repeat proteins (DARPins) such as abicipar pegol, or RG7716, may be used with the exemplary syringe. Also, embodiments of the present disclosure may be used for cosmetic applications or medical dermatology (e.g., treatment or diagnosis of allergic responses). Package 100 includes a tray 8 in which the syringe is housed during storage and a rim 9 that extends around the tray 8 and defines an opening in the tray 8. The top of the tray 8 (shown in FIG. 4) may be sealed with a removable cover 28 (FIG. 3A). A removable cover 28 may enclose the syringe within the 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 preformed plastic package and the tray 8 may be made from a moldable web, such as thermoformed plastic.

[0022] The package 100 may be suitable for use with an external sterilization process, such as a vaporized hydrogen peroxide (VHP) sterilization process and / or an ethyl alcohol sterilization process. Thus, a medical device (e.g., a prefilled syringe) may be externally sterilized by being packaged in the package 100. 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 PCT / US2018 / 021013, which is incorporated by reference in its entirety. The material used in the package 100 may be semi-permeable to the sterilant, such that when the medical device is sealed within the package 100, the sterilant can traverse a portion or all of the package 100 to sterilize the exterior of the medical device contained within the package 100 as well as the interior of 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, from Tyvek® or other suitable high density polyethylene fibers, ethylene vinyl acetate, and / or other thermoplastic materials. In some embodiments, tray 8 may include an indicator to enable 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.

[0023] As described herein, designing the package 100 to be used in conjunction with an external sterilization process and to allow a user to remove the contents of the package 100 without directly handling the contents reduces the likelihood that the sterility of the contained medical device will be compromised. As a result, the package 100, as described herein, can also reduce the likelihood that a person using the medical device will become infected by the medical device. For example, if the package 100 contains an ophthalmic syringe, the package 100 can reduce the risk of contracting an eye infection from a contaminated syringe, such as an intraocular infection such as post-injection endophthalmitis.

[0024] An externally sterilized syringe may terminate or kill live organisms on the surface of the syringe, rendering them non-viable if they may remain. The exterior surface of the syringe plunger rod, the flange, the 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 embodiments, depyrogenation and / or other removal processes may be performed prior to external sterilization.

[0025] The tray 8 may include a 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 a syringe attachment to which a needle may be coupled once the syringe is removed from the tray 8 for use. In other embodiments, the needle may already be coupled to the syringe in the package 100 and may be further covered by a cap during storage in the package 100. The cavity 2 may be configured to accommodate at least a portion of the syringe barrel (which may be a glass or plastic material compatible with a sterilant). The cavity 5 may be configured to accommodate a flange and / or plunger of the syringe. The 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, the flange portion 6 of the cavity 5 may correspond to the shape of the flange. Contrasting FIGS. 1, 5, 7, 11, and 16, the shape and / or sidewalls of the flange portion 6 of the cavity 5 may be rounded to accommodate the flange of the syringe. 2, 6, 8, 12, and 17, the interior region of flange portion 6 of cavity 5 can include, for example, rounded sidewalls, and can be configured to accommodate a flange of a syringe. In some embodiments, flange portion 6 can be a separate cavity from cavity 5. For example, in some embodiments, tray 8 can include cavity 3, cavity 2, flange portion cavity 6, and cavity 5, or a combination thereof.

[0026] In some embodiments, the syringe housed within the tray 8 may include a larger, e.g., wider, plunger rod, or a larger portion of the plunger rod, as compared to a standard syringe, e.g., to increase the stability of the clinician's hand when pressing the plunger rod for an intravitreal injection (FIGS. 7 and 8). In such embodiments, the package 100 may be sized and shaped to accommodate the larger plunger rod. If the syringe housed within the 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 or other fluid housed within the syringe, the cavity 5 may be shaped to reflect the outer shape of the flange and / or plunger with that protective element in place. However, in other embodiments, the cavity 5 may be substantially rectangular, oval, or any other suitable shape, so long as the interior region of the cavity 5 defines a space large enough to accommodate the proximal portion of the syringe (and any associated protective elements, if included). For example, Figures 5 and 6 show an exemplary embodiment in which the longitudinal sidewalls of cavity 5 are generally planar and parallel to at least a portion of the plunger rod of the syringe. Figures 7 and 8 show an exemplary embodiment in which cavity 5 may include a recess 11 shaped to correspond to the shape of at least a portion of the flange or plunger, e.g., to correspond to the shape of a protective plunger stop, cover, and / or other element to prevent movement of the syringe plunger and / or dispensing of a medicament or other fluid contained within the syringe. For example, recess 11 may be between the main region of cavity 5 and flange portion 6. In an exemplary embodiment, e.g., Figure 5, the shape of cavity 5 may be sized to facilitate high speed manufacturing of package body 100 and / or to improve material distribution of package body 100.

[0027] 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 2 may be of any suitable size and / or shape to accommodate the distal end of the syringe (and any cover associated with the distal end) and at least a portion of the syringe barrel, respectively. For example, cavities 2, 3 may be oval, circular, trapezoidal, or wider or narrower rectangular, or any combination thereof. Cavities 2, 3, 5 may be dimensioned to provide space between the walls of the cavity and the syringe to allow circulation of sterilant within package 100 during the sterilization process to sterilize the interior surfaces of package 100 and the exterior surfaces of the syringe. Tray 8 and cavities 2, 3, 5 may also have substantially flat surfaces at 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. However, in some embodiments, the cavities 2, 3, 5 and the tray 8 may have rounded shapes, e.g., cylindrical shapes, or any other suitable shapes. Also, the tray 8 may have rounded or sharp corners and / or edges. In an exemplary embodiment, for example, with reference to FIG. 5, the shape and / or size of the cavities 2, 3, 5 and the tray 8 may be shaped and / or sized to facilitate high speed manufacturing of the package 100 and / or to improve material distribution of the package 100.

[0028] In the embodiments of Figures 1, 5, 7, 11, and 16, constriction 7 extends between cavity 2 and cavities 3 and 5 to fluidly couple all three cavities. As seen in Figures 2, 6, 8, 12, and 17, constriction 7 is sized to accommodate a region of the syringe barrel therein, allowing the syringe to extend into all three cavities when the syringe is contained within package 100. For example, in Figures 2, 6, and 8, as described above, the plunger flange 14 of the packaged syringe is located within flange portion 6 of cavity 5, the syringe barrel 12 extends across cavity 2 within constriction 7, and a distal region of the syringe, at least partially covered by guard 15 (e.g., a luer lock), is located within cavity 3.

[0029] Although the tray 8 is shown as including three cavities 2, 3, 5 extending along a longitudinal axis 22 (FIGS. 2, 6, 8, 12, and 17) and connected to one another by a constriction 7, it is contemplated that the tray 8 may have any suitable number of cavities. For example, one cavity of substantially equal depth may be included, two cavities may be included, or four or more cavities may be included to hold a medical device. Each cavity (in the case of an embodiment having multiple cavities) may be connected to one another such that their combination may accommodate a medical device. Alternatively, if multiple medical devices or multiple components are accommodated within the tray 8, the tray 8 may include multiple cavities that are not connected to one another. In such an embodiment, it is contemplated that two or more of the cavities may include protrusions to facilitate removal of the medical devices and / or components from the tray 8, as described further below.

[0030] In the embodiment of FIG. 1 and FIG. 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 tray 8 configured to facilitate removal of the syringe from the package 100. The dome 4 is attached to the base of the cavity 2 such that the dome 4 is oriented below the syringe when the syringe is housed in the package 100. In the embodiment of FIG. 2, the dome 4 is aligned with the central region of the syringe barrel 12. The dome 4 may be formed of a compressible material that deforms under pressure, e.g., pressure applied by a user. The dome 4 may be formed of the same material as the rest of the tray 8, or may be formed of a different material, e.g., a material that is relatively more flexible. In some embodiments, as described above, the dome 4 and the tray 8 may be thermoformed plastic. For example, the dome 4 and / or the 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 portion of the dome 4 where it meets the base of the tray 8) can 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 can be sized to facilitate high speed manufacturing of the package 100 and / or to improve material distribution of the package 100.

[0031] FIG. 3A shows a cross-sectional view of a tray 8 containing a syringe (e.g., an empty syringe or a pre-filled syringe containing an ophthalmic medication or other fluid). As described above, the dome 4 projects outward from the base of the tray 8 away from the syringe when the syringe is received in the tray 8. The dome 4 is aligned below (or above, depending on the orientation of the tray 8) the syringe barrel 12. To remove the syringe from the package 100, the removable cover 28 can be removed (e.g., peeled off) and the tray 8 can be rotated sideways or turned upside down to position the opening of the package facing a surface. The dome 4 can then be pressed by a user. The user can press the dome 4 with one or more fingers, e.g., a thumb, toward the syringe contained within the package. When the user presses the dome 4, the package can bend such that a central portion of the package is bent toward the medical device while one or more edges of the package are bent away from the medical device. When the package 100 is bent (FIG. 3B), the syringe can be removed from the package. The package 100 is oriented with the opening facing downward in the direction of gravity (or at least perpendicular to the surface below), so that the syringe can be expelled from the package 100 onto the surface. Thus, by pushing the dome 4 to bend the package 100, the user can remove the syringe from the package 100 without directly touching the syringe. When the package 100 is turned upside down, the syringe cannot fall by itself, and the package 100 can hold the syringe suspended until the user, for example, pushes the dome 4 to bend the package 100.

[0032] When a user pushes on the dome 4 and the tray 8 is bent, the dome 4 may deform and at least partially invert. The dome 4 may or may not be configured to contact the syringe barrel 12 when the dome 4 is inverted. In some embodiments, the dome 4 may facilitate ejection of the syringe from the package 100 by pushing on the syringe barrel 12. 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 located within the tray 8. The term "apex" as used herein refers to the portion of the dome 4 furthest 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, the 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 about 5 mm to 6 mm, and the distance between the base of the tray 8 and the bottom of the syringe covering the dome 4 is about 3 mm to 4 mm. However, in other embodiments, the dome 4 may not contact the syringe barrel 12 when pressed by a user. Rather, the deflection of the tray 8 caused by pressing the dome 4 in combination with orienting the opening of the tray 8 downward in the direction of gravity may be sufficient to remove the syringe from the tray 8 and eject the syringe onto a surface (preferably a sterile surface).

[0033] A user may push the dome 4 to deflect the tray 8 before, during, and / or after orienting the tray 8 so that the opening of the tray 8 faces downward or sideways relative to the surface onto which the syringe is to be ejected (i.e., rotating the tray 8 so that the opening faces downward in the direction of gravity). Orienting the tray so that the opening faces the surface may allow the syringe to be dropped from the tray 8 onto a suitable sterile surface without the user having to directly handle the syringe to remove it from its package. Reducing the amount of handling of the syringe by the user may reduce the chance that the syringe and / or its contents may become contaminated and infect the part of the body into which the contents of the syringe are injected. For example, a sterile ophthalmic syringe may be contained within the package 100. The dome 4 and package 100 may allow the user to not compromise sterility when removing the syringe. This may ultimately reduce the risk of eye infections from contaminated syringes, such as endophthalmitis after injection. Also, reducing handling of the syringe may reduce the risk of accidentally releasing a portion of the medication or other fluid from the syringe when removing the syringe from the package 100.

[0034] Protrusions such as dome 4 and / or other protruding locations on tray 8 may not only facilitate removal of the syringe, but may also guide a user on how to handle certain portions of package 100 when removing the syringe from package 100. For example, in some embodiments, dome 4 or other portions of package 100 may include marks, indicia, and / or tactile features (e.g., ridges, bumps, or grooves) that indicate to a user where to press to flex tray 8 and remove the syringe from package 100. Overall, the inclusion of dome 4 or other suitable protrusions in tray 8 may reduce one or more of the following: injury to the user, damage to the device, loss of sterility of the device or loss of sterility of any medication or other fluids within the device, and / or the possibility of accidental release of medication or other fluids within the device.

[0035] In some embodiments, the syringe may be released from the friction fit portion of the tray 8 by pushing the dome 4 and / or bending or flexing the tray 8. For example, as shown in FIG. 4, the constriction 7 may include one or more geometric features 17 that protrude into the constriction to hold the sterile syringe in the cavity by friction fit. The geometric features 17 may be located on the sidewalls of the constriction 7 and / or on the bottom of the constriction 7 to position the syringe barrel 12 within the constriction 7. In order for the package 100 to facilitate sterilization (e.g., reduce the contact area with the syringe to maximize the surface area of ​​the syringe available for sterilization) while still retaining the syringe and packaging the syringe within the tray 8 such that the syringe is suspended within the tray 8 when the tray 8 is inverted, the syringe is pushed into the tray 8, causing the syringe barrel 12 to slide over the geometric features 17, allowing the syringe to friction fit within the tray 8. When syringe barrel 12 is pressed into place in tray 8, geometric feature 17 may hold syringe barrel 12 within constriction 7 to retain the syringe within tray 8. Pressing dome 4 may deflect tray 8 and / or push syringe barrel 12 up, causing syringe barrel 12 to move past geometric feature 17 and release the syringe from tray 8. For example, flexing tray 8 may move the portion of tray 8 including geometric feature 17 away from the syringe to release the syringe. Thus, dome 4 may be used in combination with other friction fit portions of tray 8 to facilitate release of the syringe from tray 8.

[0036] In other embodiments of the present disclosure, as shown in Figures 10-19, the geometric features 17 may include a geometric feature 17a located on a sidewall of the constriction 7 and a geometric feature 17b located on a base of the constriction 7. The geometric feature 17a may be a shoulder or may have a semicircular shape that protrudes toward the syringe, while the geometric feature 17b may have a circular shape, such as a bump or protrusion, that protrudes toward the syringe. The one or more geometric features 17b located on the base of the constriction 7 may act in conjunction with the geometric feature 17a on the sidewall of the constriction 7 to orient the syringe such that the syringe does not directly contact the sidewall of the constriction 7 and / or the sidewall of other cavities, such as the sidewalls of cavities 2, 3, 5, when the syringe is contained within the package 100. This may allow the sterilant within the package 100 to circulate within the package 100 and around the exterior surface of the syringe. By including geometric feature 17 to hold the syringe in place away from the inner surface of the package, geometric feature 17 can reduce the surface area of ​​the syringe that contacts the inner walls of package 100, thereby increasing the surface area of ​​the syringe that is exposed to the sterilant within package 100.

[0037] It should be noted that although three geometric features 17 are shown in each constriction 7 in FIG. 4, it is contemplated that fewer than three (e.g., two) or more than three geometric features 17 may be included in each constriction 7. Additionally, geometric features 17 may be included in any suitable portion of tray 8 including any combination of multiple cavities instead of or in addition to a constriction portion such as constriction 7.

[0038] 10-19 further illustrate an embodiment of the present disclosure that includes a recess 11 between the flange portion 6 and the main cavity 5. The recess 11 may also include one or more geometric features 17. For example, the recess 11 may include one or more of the geometric features 17a, 17b. As shown in FIG. 10-19, the recess 11 between the flange portion 6 and the main cavity 5 includes the geometric feature 17b. The geometric feature 17b may serve the same purpose as described above.

[0039] Figures 14 and 19 provide cross-sectional views of the embodiments shown in Figures 13 and 18, respectively. These cross-sectional views show in more detail the geometric features 17a, 17b at the constriction 7. The first and second geometric features 17a may be positioned opposite one another or may be offset from one another (not shown).

[0040] The distance between the geometric features 17a in each constriction 7 (e.g., Figs. 14 and 19) can be any suitable distance to hold a portion of a syringe (e.g., a prefilled syringe) in place. By holding one or more portions of the syringe in place, the geometric features 17a can prevent the syringe from contacting the base of the constriction 7 or the base of the cavity 2, 3, 5 of the package 100 or from falling out of the package 100. For example, referring to one constriction 7, the constriction 7 can include a pair of side walls. These side walls can include a pair of geometric features 17a, i.e., a first geometric feature 17a and a second geometric feature 17a. The first geometric feature 17a and the second geometric feature 17a can have a distance equal to or less than the diameter or width of the portion of the syringe held by the geometric features 17a. In some embodiments, the distance between the first geometric feature 17a and the second geometric feature 17b is equal to the diameter or width of the portion of the syringe held by those features. In other embodiments, the distance between the first geometric feature 17a and the second geometric feature 17b is less than the diameter or width of the portion of the syringe held by those features. In some embodiments, the distance between the first geometric feature 17a and the second geometric feature 17b is less than the diameter or width of the portion of the syringe held by those features, and is between about 0.01 mm and about 2.0 mm. In some examples, the distance between the first geometric feature 17a and the second geometric feature 17a is less than the diameter or width of the portion of the syringe held by the features, and is about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1.0 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, or about 2.0 mm. In some embodiments, the width of the portion of the syringe held by the features is the outer diameter of the syringe alone or the outer diameter of the syringe including a label attached to the syringe.

[0041] In some embodiments, the diameter or width of the portion of the syringe held by the geometric feature 17a is about 6.85 mm with no label attached to the syringe. In such embodiments, the distance between the first geometric feature 17a and the second geometric feature 17a may be 6.85 mm ± 2.0 mm (including fractional increments thereof). In other embodiments, the diameter or width of the portion of the syringe held by the geometric feature 17a is about 6.92 mm with a label attached to the syringe. In such embodiments, the distance between the first geometric feature 17a and the second geometric feature 17a may be 6.92 mm ± 2.0 mm (including fractional increments thereof).

[0042] In alternative embodiments, the distance between the first geometric feature 17a and the second geometric feature 17a is between about 4 mm and about 20 mm, between about 4.25 mm and about 19 mm, between about 4.5 mm and about 18 mm, between about 4.75 mm and about 17 mm, between about 4.75 mm and about 16 mm, between about 5 mm and about 15 mm, between about 5.25 mm and about 14 mm, between about 5.5 mm and about 13 mm, between about 4.25 mm and about 15 mm, between about 4.5 mm and about 10 mm, between about 4.75 mm and about 15 ... The length of the gap may be in the range of about 9 mm, about 5 mm to about 7.5 mm, about 5.25 mm to about 7.25 mm, about 5.5 mm to about 7.2 mm, about 5.55 mm to about 7.1 mm, about 6.6 mm to about 7.1 mm, about 6.7 mm to about 7.05 mm, about 6.75 mm to about 6.95 mm, about 6.8 mm to about 6.9 mm, about 6.8 mm to about 7.1 mm, about 6.85 mm to about 7.1 mm, or about 6.85 mm to about 7.05 mm. In some examples, the first geometric feature 17a and the second geometric feature 17a are about 4.7 mm, about 4.8 mm, about 4.9 mm, about 5 mm, about 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, about 5.5 mm, about 5.6 mm, about 5.7 mm, about 5.8 mm, about 5.9 mm, about 6 mm, about 6.1 mm, about 6.2 mm, about 6.3 mm, about 6.4 mm, about 6.5 mm, about 6.6 mm, In other examples, the first geometric feature 17a and the second geometric feature 17a may have a distance of about 5 mm±0.5 mm, about 6 mm±0.5 mm, about 7 mm±0.5 mm, about 8 mm±0.5 mm, about 9 mm±0.5 mm, or about 10 mm±0.5 mm.

[0043] In embodiments in which the sidewall of recess 11 includes first and second geometric features 17a, 17a, the distance between first and second geometric features 17a in recess 11 may be the same as the distance between first and second geometric features 17a in constriction 7. In other embodiments, the distance between first and second geometric features 17a in recess 11 is different from the distance between first and second geometric features 17a in constriction 7.

[0044] Although reference is made herein to a dome-shaped portion, one skilled in the art can appreciate that the dome-shaped portion may have any suitable shape, so long as the protrusion on the tray 8 can be pressed to deflect the tray 8 and / or compressed into an inverted position. For example, as discussed above, the embodiment of FIGS. 15-19 may include one or more cavities having an elongated shape. The one or more cavities may have a protrusion having an elongated or rectangular shape to correspond to the shape of the corresponding cavity. Additionally, although the tray 8 is shown as including three cavities 2, 3, 5 connected to each other by a constriction 7, it is contemplated that the tray 8 may have any suitable shape with one or more cavities for housing a medical device. For example, although the embodiments of the present disclosure are directed to packaging for syringes, e.g., prefilled syringes, it can be appreciated that the protrusion, such as the dome 4, may be used with packaging for any suitable medical device and / or consumer goods. The dome 4 may have any size and / or shape to facilitate removal of the syringe from the package. The dimensions of the dome 4 are as described in the present disclosure. For example, the domes 4 may have a generally circular shape (FIG. 20A) or a generally rectangular shape (FIG. 20B). Thus, the tray 8 may be shaped to accommodate other types of medical devices. Also, multiple protrusions (e.g., multiple domes 4) may be incorporated into the tray 8 to facilitate removal of the medical devices therein.

[0045] As discussed above, the use of dome 4 in a package, such as a blister package, to release a syringe contained within the package can promote sterility, dose accuracy, and / or safety of the syringe and the user by reducing the amount of direct contact a user must have with the syringe before administering the contents of the syringe to a person, which in turn can reduce the risk of accidentally releasing the contents of the syringe before administering a medication or other fluid to a person, reducing the incidence of infection in a person.

[0046] In some embodiments, cavities 2, 3, 5 may not include protrusions. For example, referring to FIGS. 15-19, a user may push one of cavities 2, 3, 5 to deflect tray 8, thereby moving the syringe past geometric feature 17 and releasing it from tray 8. In another example, a user may maintain the sterility of the syringe after removing cover 28, and the user may grasp a portion of the syringe held in one or more of the constrictions 7 to release the syringe from geometric feature 17. For example, referring to FIG. 17, a user may reach into tray 8 and grasp a portion of the syringe held at constriction 7 between cavities 2, 3, or between cavities 2, 5, or in cavity 2. The user may then pull the syringe until it is released from geometric feature 17a and / or geometric feature 17b.

[0047] 1 and 2, the package 100 may further include an edge 9 that extends around at least a portion of the tray 8 to define an opening of the tray 8. The edge 9 may allow a removable cover 28, such as a peelable cover 28, to cover and seal the top opening of the tray 8 to accommodate the medical device within the tray 8 during storage. An adhesive 18, such as a glue, paste, film, tape, pressure sensitive material, and / or low temperature adhesive, may be used to seal the removable cover 28 to the edge 9. The adhesive 18 may be used to match the type of external sterilization that may be performed on the package 100. The width of the adhesive 18 may be changed depending on the size of the top opening of the tray 8. For example, as the size of the top opening of the tray 8 increases, the width of the adhesive 18 may decrease. A corner of the edge 9, such as corner 16 in FIG. 2, may be free of adhesive 18 so that a user can lift the removable cover 28 from the corner 16 to remove the cover from the tray 8. As shown in FIGS. 6 and 8, the corner 16 may include a tab 20 (or other protrusion or indentation) that allows a user to lift the removable cover 28 off the corner 16 and remove the cover 28 from the tray 8. The tab 20 may be included on the corner 16 of the edge 9 or on the corner 16 of the removable cover 28. In an exemplary embodiment, with reference to FIGS. 2 and 6, the type, shape, and / or size of the edge 9 or tab 20 (or other protrusion or indentation) may be configured to facilitate high speed manufacturing of the package 100 and / or to improve material distribution of the package 100. The removable cover 28 may be made of any suitable material, such as foil paper, plastic, etc. Also, the removable cover 28 may be permeable to a suitable gaseous sterilant, such as vaporized hydrogen peroxide, ethyl alcohol, nitrous oxide, or any suitable sterilant in the art.

[0048] In use, a user may first remove the removable cover 28 from the tray 8, for example by peeling the removable cover 28 from the edge 9 to expose the opening of the tray 8. The user may then turn the tray 8 sideways or upside down so that the opening faces the surface from which the medical device (e.g., a prefilled ophthalmic syringe) is to be ejected. Subsequently, or simultaneously, the user may push the dome 4 (or other protrusions) to deflect the tray 8 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. Pushing the dome 4 may at least partially invert the dome 4. In some embodiments, the inverted portion of the dome 4 may contact the medical device (e.g., the syringe barrel 12), while in other embodiments, the dome 4 may not contact the syringe at all. In this manner, pushing the dome 4 to deflect the tray 8 may eject the medical device from the tray 8 such that the medical device lands on the surface to which the opening of the tray 8 was directed. Suitable sterile surfaces may include, for example, a sterile table, a tray for holding medical devices, a cloth, a liner, or any other suitable sterile surface. A combination of pushing dome 4, inverting dome 4, bending tray 8, and / or rotating tray 8 sideways or upside down can orient the base of tray 8 above the syringe and above the sterile surface to allow the user to retrieve the syringe without actually directly contacting the syringe.

[0049] In some embodiments, pushing the dome 4 to deflect the tray 8 may release the medical device from a friction fit portion of the tray 8, e.g., one or more geometric features 17. Rotating the tray 8 may allow the syringe to fall off the tray 8 when the syringe is released from the tray 8 (e.g., through flipping and / or bending of the dome 4). 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 / or to deflect different portions of the tray 8.

[0050] In the case of packaging for prefilled syringes, any additional packaging on the syringe (e.g., a distal guard or luer lock, and / or a plunger guard) may be removed from the syringe when the syringe is released from the tray 8. In some embodiments, a syringe may be contained within the package 100 without a needle, and a needle, such as a stake needle, may be attached to the distal end of the syringe, such as via a needle attachment. The contents of the syringe (e.g., aflibercept (Eylea®), ranibizumab (Lucentis®), bevacizumab (Avastin®), conbercept, OPT-302, RTH258 (brolucizumab), pegylated designed ankyrin repeat proteins (DARPins) like abicipar pegol, or large and / or small molecule antagonists of VEGF and / or ANG-2, such as RG7716) may then be injected into the recipient's eye.

[0051] As discussed above, the components of package 100, as well as the size and / or shape of such components, may be configured to facilitate high speed manufacturing of package 100 and / or improve material distribution of package 100. Figure 9 is an exemplary embodiment illustrating a portion of the manufacturing process for package 100, in which packages 101a, 101b, 101c are sealed with material 30 forming a removable cover 28 (Figure 3A), which may be, for example, Tyvek or other suitable high density polyethylene fiber, ethylene vinyl acetate, and / or other thermoplastic material.

[0052] The above description and examples are illustrative and not restrictive. Those skilled in the art may make many variations and / or modifications without departing from the general scope of the invention. For example, as noted above, the above embodiments (and / or aspects thereof) may be used in combination with each other. Also, parts of the above embodiments may be omitted without departing from the scope of the invention. Also, modifications may be made to adapt a particular situation or aspect to the teachings of the various embodiments without departing from their scope. Many other embodiments may be apparent to those skilled in the art upon reviewing the above description. Furthermore, features of any embodiment may be used in conjunction with any of the other disclosed embodiments.

[0053] Implementations of the present disclosure may include the following features. (Item 1) A package comprising: a tray having an opening, a cavity including at least three cavities, a plurality of side walls, and a base; a sterile syringe contained within said cavity and pre-filled with a medication or other fluid; Equipped with a first cavity comprising a plunger rod of the sterile syringe, a second cavity comprising a barrel of the sterile syringe, and a third cavity comprising a needle attachment of the sterile syringe, the at least three cavities being interconnected by a plurality of intermediate constrictions; each of the constrictions includes a first side wall, a second side wall, a base, and a plurality of geometric features that protrude into the constriction to position the sterile syringe away from the plurality of side walls.

[0054] (Item 2) The package of item 1, wherein the first side wall of each of the constrictions includes a first geometric feature and the second side wall of each of the constrictions includes a second geometric feature. (Item 3) The package of item 2, wherein the distance between the first geometric feature and the second geometric feature is less than the width of the portion of the sterile syringe contained within the constriction and is less than about 2.0 mm.

[0055] (Item 4) The package according to item 2, wherein the distance between the first geometric feature and the second geometric feature is in the range of about 5.5 mm to about 6.5 mm. (Item 5) The package of item 2, wherein the base of the constriction includes a third geometric feature.

[0056] (Item 6) The package of item 1, further comprising a protrusion associated with the tray at a position that coincides with a portion of the sterile syringe. (Item 7) The package of item 1, wherein the first cavity includes a flange portion configured to hold a flange of the syringe.

[0057] (Item 8) The package of item 7, wherein a recess is located between the flange portion and the first cavity portion. (Item 9) The package of item 1, wherein each of the at least three cavities has a rectangular shape.

[0058] (Item 10) The package of item 2, wherein each of the at least three cavities has a rectangular shape with rounded corners. (Item 11) A package for a sterile syringe, comprising: A tray having an opening, a cavity including a plurality of cavities, a plurality of side walls, and a base, the plurality of cavities are connected to one another by a plurality of intermediate constrictions, each constriction including a first side wall, a second side wall and a base; the tray, wherein each of the first side wall, the second side wall, and the base includes a geometric feature extending away from the corresponding side wall or base and projecting into the constriction to position the sterile syringe away from the side walls; a rim surrounding the opening and extending radially outward from the cavity to define a periphery of the tray; a removable cover having a periphery bonded to said edge, said cover being permeable to the gaseous sterilant; A package comprising:

[0059] (Item 12) The package described in Item 11, wherein the geometric feature on the first sidewall is a first geometric feature, the geometric feature on the second sidewall is a second geometric feature, and the distance between the first geometric feature and the second geometric feature is in the range of about 5.5 mm to about 6.5 mm.

[0060] (Item 13) The package described in Item 10, wherein the multiple cavities include at least three cavities, a first cavity includes a plunger rod of the sterile syringe, a second cavity includes a barrel of the sterile syringe, and a third cavity includes a needle attachment portion of the sterile syringe.

[0061] 14. The package of claim 11, wherein the gaseous sterilant is one or more of vaporized hydrogen peroxide, ethylene oxide, or nitrous oxide. 15. A method of removing an external sterile syringe from a package, the package including a tray having a cavity, a plurality of geometric features associated with the cavity, and a removable cover, the method comprising: removing the removable cover to expose an opening of the tray; grasping a portion of the outer sterile syringe held by the plurality of geometric features; removing the outer sterile syringe from the tray to move the plurality of geometric features away from the outer sterile syringe to release the outer sterile syringe from the tray; A method for providing the above.

[0062] (Item 16) The method according to item 15, wherein the external sterile syringe is pre-filled with aflibercept, ranibizumab, bevacizumab, conbercept, OPT-302, RTH258 (brolucizumab), pegylated designed ankyrin repeat protein (DARPin), or RG7716.

[0063] 17. The method of claim 15, wherein the tray is manufactured from a material comprising one or more of polypropylene, polystyrene, polyethylene, polycarbonate, polyvinyl chloride, or polyethylene terephthalate glycol.

[0064] 18. The method of claim 15, wherein the removable cover is permeable to a gaseous sterilant. 19. The method of claim 18, wherein the gaseous sterilant is vaporized hydrogen peroxide.

[0065] (Item 20) The method of item 15, further comprising pushing a portion of the package forward of the cavity of the tray, wherein pushing the portion of the package causes a portion of the tray to bend.

[0066] 21. The method of claim 20, further comprising: releasing the external sterile syringe from the plurality of geometric features by pressing the portion of the tray. 22. The method of claim 20, wherein the portion of the package that is pressed includes a deformable protrusion.

[0067] 23. The method of claim 15, wherein the tray is manufactured by thermoforming injection or blow molding techniques.

Claims

1. A package comprising: a tray having an opening, a cavity including at least three cavities, a plurality of side walls, and a base; a sterile syringe contained within said cavity and pre-filled with a medication or other fluid; Equipped with a first cavity comprising a plunger rod of the sterile syringe, a second cavity comprising a barrel of the sterile syringe, and a third cavity comprising a needle attachment of the sterile syringe, the three cavities being interconnected by a plurality of intermediate constrictions; each of the constrictions includes a first side wall, a second side wall, a base, and a plurality of geometric features protruding into the constriction for positioning the sterile syringe away from the plurality of side walls.

2. 2. The package of claim 1, wherein the first sidewall of the constriction includes a first geometric feature and the second sidewall of the constriction includes a second geometric feature.

3. 3. The package of claim 2, wherein the distance between the first geometric feature and the second geometric feature is less than a width of the portion of the sterile syringe contained within the constriction and is less than about 2.0 mm.

4. The package of claim 2 , wherein the distance between the first geometric feature and the second geometric feature ranges from about 5.5 mm to about 6.5 mm.

5. The package of claim 2 , wherein the base of the constriction includes a third geometric feature.

6. 10. The package of claim 1, further comprising a protrusion associated with the tray in a location that coincides with a portion of the sterile syringe.

7. The package of claim 1 , wherein the first cavity includes a flange portion configured to retain a flange of the sterile syringe.

8. The package of claim 7 , wherein a recess is located between the flange portion and the first cavity portion.

9. The package of claim 1 , wherein each of the at least three cavities has a rectangular shape.

10. The package of claim 1 , wherein each of the at least three cavities has a rectangular shape with rounded corners.

11. A package for a sterile syringe, comprising: A tray having an opening, a cavity including a plurality of cavities, a plurality of side walls, and a base, the plurality of cavities are connected to one another by a plurality of intermediate constrictions, each constriction including a first sidewall, a second sidewall and a base; the tray, wherein each of the first side wall, the second side wall, and the base includes a geometric feature extending away from the corresponding side wall or base and projecting into the constriction to position the sterile syringe away from the plurality of side walls; a rim surrounding the opening and extending radially outward from the cavity to define a periphery of the tray; a removable cover having a periphery bonded to said edge, said cover being permeable to the gaseous sterilant; A package comprising:

12. 12. The package of claim 11, wherein the geometric feature on the first sidewall is a first geometric feature and the geometric feature on the second sidewall is a second geometric feature, and a distance between the first geometric feature and the second geometric feature ranges from about 5.5 mm to about 6.5 mm.

13. 12. The package of claim 11, wherein the plurality of cavities comprises at least three cavities, a first cavity comprising a plunger rod of the sterile syringe, a second cavity comprising a barrel of the sterile syringe, and a third cavity comprising a needle attachment of the sterile syringe.

14. 12. The package of claim 11, wherein the gaseous sterilant is one or more of vaporized hydrogen peroxide, ethylene oxide, or nitrous oxide.

15. 1. A method of removing an external sterile syringe from a package, the package including a tray having a cavity, a plurality of geometric features associated with the cavity, and a removable cover, the method comprising: removing the removable cover to expose an opening of the tray; grasping a portion of the outer sterile syringe held by the plurality of geometric features; removing the outer sterile syringe from the tray to move the plurality of geometric features away from the outer sterile syringe to release the outer sterile syringe from the tray; A method for providing the above.

16. 16. The method of claim 15, wherein the external sterile syringe is pre-filled with aflibercept, ranibizumab, bevacizumab, conbercept, OPT-302, RTH258 (brolucizumab), pegylated designed ankyrin repeat protein (DARPin), or RG7716.

17. 16. The method of claim 15, wherein the tray is manufactured from a material comprising one or more of polypropylene, polystyrene, polyethylene, polycarbonate, polyvinyl chloride, or polyethylene terephthalate glycol.

18. 16. The method of claim 15, wherein the removable cover is permeable to a gaseous sterilant.

19. 20. The method of claim 18, wherein the gaseous sterilant is vaporized hydrogen peroxide.

20. 16. The method of claim 15, further comprising pushing a portion of the package forward of the cavity of the tray, wherein pushing the portion of the package causes a portion of the tray to deflect.

21. 21. The method of claim 20, further comprising: pressing the portion of the tray to release the external sterile syringe from the plurality of geometric features.

22. 21. The method of claim 20, wherein the portion of the package that is pressed includes a deformable protrusion.

23. The method of claim 15, wherein the tray is manufactured from a thermoforming injection or blow molding technique.

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