Device container

The container addresses the limitations of existing treatment kit containers by providing a structured design that enhances ergonomics, versatility, and ease of use, allowing for safe and efficient preparation and administration of therapeutic agents.

JP7654840B2Active Publication Date: 2025-04-01BIOVERATIV THERAPEUTICS INC
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Patent Information

Application Number
JP2024000145
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2012-07-03
Filing Date
2024-01-04
Publication Date
2025-04-01
Estimated Expiration
2033-07-03

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Abstract

To provide a container for a therapeutic kit exhibiting improved ergonomics, multiple application performance, durability, and / or ease of use.SOLUTION: A device container such as a therapeutic kit is disclosed. According to one embodiment, the device container comprises: a first member configured to releasably hold a syringe barrel; a second member configured to releasably hold a vial, that is connected to the first member by a first hinge; and a third member configured to releasably hold a vial adapter, that is connected to the second hinge by a second hinge. According to one embodiment, the first, second and third members each are formed as a single structure.SELECTED DRAWING: Figure 4
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Description

[Technical field]

[0001] The present invention relates generally to device containers. More specifically, embodiments of the present invention relate to containers for medical kits with improved ergonomics, versatility, durability, and / or ease of use. [Background technology]

[0002] Many people suffer from diseases or medical conditions that require treatment with a therapeutic agent. Preparation and administration of a therapeutic solution to an individual often involves mixing two or more drugs or other substances to form a therapeutic solution, and then delivering the mixed therapeutic solution to an individual. Mixing drugs or other substances often involves extracting one drug or other substance in liquid form from a vial or other container, and transferring this drug or other substance to a separate container that holds the other drug or substance, such as a syringe.

[0003] Some therapeutic agents are sold to patients and caregivers as part of a therapeutic "kit." These kits may include, for example, one or more vials, syringes, and drugs or substances that form the therapeutic solution, as well as containers for housing these components.

[0004] Existing medical kit containers suffer from many shortcomings. For example, many existing medical kit containers are overly large and / or not durable enough, making them not convenient or safe to store or transport. As a further example, many existing medical kit containers are essentially empty containers, have no form of internal organization, and lack ergonomic structure, so that the user may be required to locate or hunt for the necessary components at a given time. Finally, while many existing medical kit containers can simply store their contents before use, these containers do not include structural features that may actually assist the user in preparing and administering the medical solution.

[0005] There is a need for new treatment kit containers that provide improved ergonomics, versatility, durability, and / or ease of use for patients and caregivers preparing and administering treatments.

[0006] However, while this discussion focuses primarily on treatment kit containers, it should be noted that some embodiments of the device containers described herein need not be limited to use with treatment kits, but may be suitable for storing items for a variety of non-therapeutic and non-medical purposes. Summary of the Invention [Means for solving the problem]

[0007] An embodiment of the invention may relate to a container having a closed configuration and an open configuration. The container may include a first member having an outer surface, a second member having an outer surface, the second member being connected to the first member by a first hinge, and a third member having an outer surface, the third member being connected to the second member by a second hinge, the container being configured such that when in the closed configuration, the outer surfaces of the first and third members are substantially parallel to each other and face opposite each other, and when in the open configuration, the container is configured such that the outer surfaces of the first, second, and third members are substantially parallel to each other and face in the same direction.

[0008] Embodiments of the invention may also relate to a container having a closed configuration and an open configuration. The container may include a top plate, a side plate configured to releasably hold a vial, and a bottom plate, where when the container is in the closed configuration, the top plate and the bottom plate are configured such that the top plate and the bottom plate are substantially parallel to one another, the side plate is substantially perpendicular to the top plate and the bottom plate, and the side plate is configured to releasably hold a vial such that a longitudinal axis of the vial is substantially parallel to the top plate and the bottom plate.

[0009] Embodiments of the invention may further relate to a container that may include a first member configured to releasably hold a syringe barrel, a second member configured to releasably hold a vial, the second member coupled to the first member by a first hinge, and a third member configured to releasably hold a vial adapter, the third member coupled to the second member by a second hinge.

[0010] Embodiments of the invention may also relate to treatment kits that may include a syringe barrel, a vial having a cap and a base, and a container for holding the syringe barrel and the vial, where the container may include a member configured to releasably hold the vial by its base, and the container configured such that a user can connect the syringe barrel to the cap of the vial without first releasing the vial from the member.

[0011] Embodiments of the invention may further relate to treatment kits that may include a syringe barrel having a longitudinal axis, a vial having a longitudinal axis, and a container for holding the syringe barrel and the vial, the container having a closed configuration and an open configuration, where the container may include a first member configured to releasably hold the syringe barrel and a second member configured to releasably hold the vial, where when the container is in its closed position, the longitudinal axis of the syringe barrel is generally parallel to the longitudinal axis of the vial, and when the container is in its open position, the longitudinal axis of the syringe barrel is generally perpendicular to the longitudinal axis of the vial.

[0012] Embodiments of the invention may also relate to treatment kits that may include a vial, a syringe barrel, and a container for holding the syringe barrel and the vial, where the container may include a member configured to releasably hold the vial in an upright position, the container configured to provide stability to the vial when the vial is releasably held in the upright position, and the container further configured to provide stability to the syringe barrel when the syringe barrel is coupled to the vial when the vial is still releasably held in the upright position.

[0013] In some embodiments of the invention, containers configured for releasably holding syringes, vials, and vial adapters may be housed within a larger outer container which may itself include labeling, marketing, or other product information on a surface of the outer container.

[0014] In addition to the syringes, vials, and vial adapters, in further embodiments of the present invention, the treatment kits may include additional elements such as, for example, product instructions, an injection needle set, alcohol swabs, gauze pads, or band-aids. Such additional elements may be included within the same container that holds the syringes, vials, and vial adapters within the larger outer container, or in entirely separate containers included in the kit.

[0015] In other embodiments of the present invention, a single treatment kit may be configured to hold multiple syringes, multiple vials, and / or multiple vial adapters.

[0016] While this discussion focuses primarily on treatment kit containers, it should be noted that some embodiments of the device containers described herein need not be limited to use with treatment kits, but may be suitable for storing items for a variety of non-therapeutic and non-medical purposes.

[0017] Further embodiments, features, and advantages of the present invention, as well as the structure and operation of the various embodiments of the present invention, are described in detail below with reference to the accompanying drawings. The present specification also provides, for example, the following items: (Item 1) A container having a closed configuration and an open configuration, a first member having an outer surface; a second member having an outer surface, the second member being coupled to the first member by a first hinge; a third member having an outer surface, the third member being coupled to the second member by a second hinge; the container is configured such that when in the closed configuration, the outer surfaces of the first and third members are generally parallel to one another and face away from one another; The container is configured such that when the container is in the open configuration, the outer surfaces of the first, second, and third members are generally parallel to one another and face in the same direction. (Item 2) Item 1, wherein the first, second, and third members are formed as a unitary structure. (Item 3) Item 3. The container of item 2, wherein the first, second, and third members are formed by an injection molding process. (Item 4) 2. The container of claim 1, wherein the first and second hinges are living hinges. (Item 5) 2. The container of claim 1, wherein the second member is configured to releasably hold a vial. (Item 6) Item 6. The container of item 5, wherein the container is configured to releasably retain a syringe barrel. (Item 7) 7. The container of claim 6, wherein the container is configured to allow a user to connect the syringe barrel to the vial without first releasing the vial from the container. (Item 8) 7. The container of claim 6, wherein the container is configured to provide stability to the syringe barrel when the syringe barrel is coupled to the vial while the vial is still releasably held in place. (Item 9) A container having a closed configuration and an open configuration, The top plate and a side plate configured to releasably retain a vial; A bottom plate; When the container is in the closed configuration: The top plate and the bottom plate are substantially parallel to each other, The side panels are generally perpendicular to the top and bottom panels; The container, wherein the side panels are configured to releasably hold a vial such that a longitudinal axis of the vial is generally parallel to the top and bottom panels. (Item 10) When the container is in the open configuration: The top plate, the side plate, and the bottom plate are substantially parallel to each other; 10. The container of claim 9, wherein the side panels are configured to releasably hold the vial such that a longitudinal axis of the vial is generally perpendicular to the top, side, and bottom panels. (Item 11) 10. The container of claim 9, wherein the top, side, and bottom panels are formed as a unitary structure. (Item 12) Item 12. The container of item 11, wherein the top, side, and bottom panels are formed by an injection molding process. (Item 13) 10. The container of claim 9, wherein the top, side, and bottom panels are connected together via one or more living hinges. (Item 14) 10. The container of claim 9, wherein the container is configured to releasably retain a syringe barrel. (Item 15) Item 16. The container of item 14, wherein the container is configured to allow a user to connect the syringe barrel to the vial without first releasing the vial from the shroud. Item 15. The container of item 14, wherein the container is configured to provide stability to the syringe barrel when the syringe barrel is coupled to the vial while the vial is still releasably held in place. (Item 17) A container comprising: a first member configured to releasably retain a syringe barrel; a second member configured to releasably hold a vial, the second member being coupled to the first member by a first hinge; a third member configured to releasably hold a vial adapter, the third member coupled to the second member by a second hinge. (Item 18) Item 18. The container of item 17, wherein the first, second, and third members are formed as a unitary structure. (Item 19) Item 19. The container of item 18, wherein the first, second, and third members are formed by an injection molding process. (Item 20) Item 18. The container of item 17, wherein the first, second, and third members are connected together via one or more living hinges. (Item 21) Item 18. The container of item 17, wherein the container is configured such that a user can connect the syringe barrel to the vial without first releasing the vial from the second member. (Item 22) Item 18. The container of item 17, wherein the container is configured to provide stability to the syringe barrel when the syringe barrel is coupled to the vial while the vial is still releasably held in place. (Item 23) A treatment kit comprising: A syringe barrel; a vial having a cap and a base; A container for holding a syringe barrel and the vial, comprising: a container comprising a member configured to releasably hold the vial by its base; A treatment kit, wherein the container is configured to allow a user to connect the syringe barrel to the cap of the vial without first releasing the vial from the member. (Item 24) 24. The treatment kit of claim 23, wherein the container is formed by an injection molding process. (Item 25) 24. The treatment kit of claim 23, wherein the container is configured to open and close using one or more living hinges. (Item 26) 24. The treatment kit of claim 23, wherein the container is configured to provide stability to the syringe barrel when the syringe barrel is coupled to the vial while the vial is still releasably held in place. (Item 27) A treatment kit comprising: a syringe barrel having a longitudinal axis; a vial having a longitudinal axis; a container for holding the syringe barrel and the vial, the container having a closed configuration and an open configuration; a first member configured to releasably retain the syringe barrel; a second member configured to releasably hold the vial; when the container is in its closed position, the longitudinal axis of the syringe barrel is generally parallel to the longitudinal axis of the vial; A treatment kit, wherein when the container is in its open position, the longitudinal axis of the syringe barrel is substantially perpendicular to the longitudinal axis of the vial. (Item 28) Item 28. The treatment kit of item 27, wherein the first and second members are formed as a unitary structure. (Item 29) Item 29. The treatment kit of item 28, wherein the first and second members are formed by an injection molding process. (Item 30) Item 28. The treatment kit of item 27, wherein the first and second members are connected together by a living hinge. (Item 31) 28. The treatment kit of claim 27, wherein the container is configured to allow a user to connect the syringe barrel to the vial without first releasing the vial from the second member. (Item 32) 28. The treatment kit of claim 27, wherein the container is configured to provide stability to the syringe barrel when the syringe barrel is coupled to the vial while the vial is still releasably held in place. (Item 33) A treatment kit comprising: A vial, A syringe barrel; a container for holding the syringe barrel and the vial, a container comprising a member configured to releasably retain the vial in an upright position; the container is configured to provide stability to the vial when the vial is releasably held in an upright position; The treatment kit, wherein the container is further configured to provide stability to the syringe barrel when the syringe barrel is coupled to the vial while the vial is still releasably held in an upright position. (Item 34) 34. The treatment kit of claim 33, wherein the container is formed by an injection molding process. (Item 35) 34. The treatment kit of claim 33, wherein the container is configured to open and close using one or more living hinges. (Item 36) Item 34. The treatment kit of item 33, wherein the container is configured to allow a user to connect the syringe barrel to the vial without first releasing the vial from the second member. [Brief description of the drawings]

[0018] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate the present invention by way of example, and not by way of limitation, and together with the description, further serve to explain the principles of the invention and enable those skilled in the art to make and use the invention.

[0019] [Figure 1]FIG. 1 is a top front perspective view of a treatment kit container in an open configuration including various components according to an embodiment of the present invention. [Diagram 2] FIG. 2 is a top front perspective view of a treatment kit container in a closed configuration according to an embodiment of the present invention. [Figure 3A] FIG. 1 is a top rear perspective view of a treatment kit container in a closed configuration according to an embodiment of the present invention. [Figure 3B] FIG. 2 is a bottom view of a treatment kit container in a closed configuration according to an embodiment of the present invention. [Figure 4] FIG. 1 is a top front perspective view of an empty treatment kit container in an open configuration according to an embodiment of the present invention. [Diagram 5] FIG. 1 is a top front perspective view of a treatment kit container in an open configuration including various components according to an embodiment of the present invention. [Figure 6] FIG. 1 is a top view of a treatment kit container in an open configuration including various components according to an embodiment of the present invention. [Figure 7] FIG. 2 is a right side view of a treatment kit container in an open configuration including various components according to an embodiment of the present invention. [Figure 8] FIG. 2 is a right side view of a treatment kit container in an open configuration including various components assembled together in accordance with an embodiment of the present invention. [Figure 9A] FIG. 1 is a front view of two treatment kit containers stacked on top of each other in a closed configuration according to an embodiment of the present invention. [Figure 9B] FIG. 1 is a front view of 48 treatment kit containers stacked on top of each other in a closed configuration according to an embodiment of the present invention. [Figure 10] FIG. 1 is a top front perspective view of a treatment kit container in an open configuration including various components according to an alternative embodiment of the present invention. [Figure 11] FIG. 1 is a top rear perspective view of an empty treatment kit container in an open configuration according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] The present invention will now be described in detail with reference to embodiments thereof as illustrated in the accompanying drawings. References to "one embodiment," "embodiment," "example embodiment," and the like indicate that the described embodiment may include particular features, structures, or characteristics, but not all embodiments may necessarily include those particular features, structures, or characteristics. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is believed to be within the knowledge of one of ordinary skill in the art to operate such feature, structure, or characteristic in connection with other embodiments, whether or not expressly described.

[0021] Many people suffer from a disease or medical condition that requires treatment with a therapeutic agent. As used herein, the term "therapeutic agent" refers to something related to the treatment or cure of a disease or medical condition. Therapeutic treatment may involve, for example, a drug, a medical device, or physical activity. As used herein, the term "drug" refers to a substance for treating or curing a disease or medical condition.

[0022] Some therapeutics, such as drugs or medical devices, may be sold to patients and caregivers as treatment "kits." Figure 1 is a top front perspective view of a treatment kit 100 container 101 in an open configuration containing various components according to an embodiment of the present invention. Treatment kits 100 are useful to patients and caregivers because they can contain one or more drugs, medical devices, and / or other components in a single package for use in administering the treatment.

[0023] 1, treatment kit 100 may include container 101. Container 101 may be anything configured to contain an object or material, such as, for example, a carton, box, crate, can, or bottle. Containers 101 according to embodiments of the invention may come in a variety of shapes and sizes, be made from a variety of materials, and have a variety of opening and closing configurations.

[0024] In one embodiment of the invention, as illustrated throughout the figures, the treatment kit 100 container 101 may be generally shaped like a rectangular prism with rounded edges when in its closed configuration. In other embodiments, the container 101 may be generally shaped like a cube, triangular prism, cylinder, sphere, cone, or frustocone, for example, with either straight or rounded edges. In some embodiments, rounded edges may be desirable as they may pose less risk of injury to sensitive patients.

[0025] The overall size of the container 101 in its closed configuration may vary depending on the size and shape of the medication, medical device, and / or other components stored in the container. In one embodiment, the container 101 may be 2.1-3.1 inches wide, 3.5-4.5 inches long, and 1.0-2.0 inches tall when in its closed configuration. In one embodiment, the container 101 may be about 2.6 inches wide, about 4.0 inches long, and about 1.5 inches tall when in its closed configuration. In some embodiments, the overall size of the container 101 in its closed configuration should be minimized as a smaller container 101 may be easier for a patient or caregiver to store or transport, especially when storing or carrying multiple containers 101.

[0026] Treatment kit 100 container 101 according to embodiments of the present invention may be made from a wide variety of materials including, for example, plastics such as polypropylene, polyvinyl chloride, polytetrafluoroethylene, polyethersulfone, polyethylene, polyurethane, polyetherimide, polycarbonate, polyetheretherketone, polysulfone, cyclic olefin polymer, or cyclic olefin copolymer, cardboard, paper, metal, glass, wood, or combinations thereof. In some embodiments, forming container 101 entirely from a plastic such as polypropylene may be desirable because the resulting container can be cost-effectively formed by an injection molding process and can be configured to be both structurally durable and waterproof.

[0027] In some embodiments of the invention, the treatment kit 100 may also include a larger outer container for housing the container 101. The larger outer container may be used to store and protect the container 101 at various points during manufacture, distribution, sale, and / or use, and may include labeling, marketing, or other product information on a surface of the outer container. The large outer container may be made from a wide variety of materials including, for example, plastic, cardboard, paper, metal, glass, wood, or combinations thereof.

[0028] Different containers 101 according to embodiments of the present invention may have a variety of open and closed configurations. In some embodiments, it may be desirable for the interior of the container 101 to always be open to the outside environment. In such embodiments, the container 101 may have only a single configuration, where contents can be freely added or removed from the open container 101. In other embodiments, it may be desirable for the container to have separate opening and closing configurations, where the contents of the container 101 are not easily accessible from the outside environment in the closed configuration, but are easily accessible from the outside environment in the open configuration.

[0029] In accordance with one embodiment of the present invention, Figure 1 illustrates the treatment kit 100 container 101 (including various components) in an open configuration, while Figure 2 illustrates the treatment kit 100 container 101 in a closed configuration. In both configurations, the container, or a portion thereof, can define one or more interior spaces 114 within the container 101.

[0030] The container 101 depicted in Figure 1 can be considered to be comprised of multiple members. These members include a first member 102, a second member 104, and a third member 106. In other embodiments, the container 101 can be comprised of fewer or more than three members. The first member 102 and the third member 106 depicted in Figure 1 include relatively large flat plates and upwardly projecting sidewalls, while the second member 104 more closely resembles a small flat plate without upwardly projecting sidewalls.

[0031] The first member 102, the second member 104, and the third member 106 may be joined together by one or more hinges 108. With respect to the container 101 illustrated in FIG. 1, the first member 102 is joined to the second member 104 by a first hinge 108, and the second member 104 is joined to the third member 106 by a second hinge 108. The hinges 108 may be, for example, living hinges, back hinges, flush hinges, barrel hinges, hidden hinges, or piano hinges. In some embodiments, one or more hinges may not be present and the members of the container 101 may be completely separable from one another. In embodiments in which the container 101 is formed from plastic by an injection molding process, the living hinges 108 connecting the various members may be formed during the injection molding process.

[0032] A treatment kit 100 container 101 according to an embodiment of the present invention can house one or more drugs, medical devices, and / or other components for use in administering a treatment. With reference to FIG. 1, in one embodiment, container 100 can be configured to store a syringe 200, a vial 300, and a vial adapter 400. Syringe 200 can optionally be separated into syringe 200 barrel 202 and syringe 200 plunger rod 204 components while stored in container 100. In another embodiment, container 101 can be configured to store fewer or more components than specified above, or can be configured to store completely different components.

[0033] Some therapeutic treatments involve preparing and administering a therapeutic solution to a patient, which may involve mixing two or more drugs or other substances to form the therapeutic solution. Mixing drugs or other substances often involves extracting one drug or substance in liquid form from a vial 300 or other container and transferring the drug substance to a separate container (such as the syringe 200 barrel 202) that holds the other drug or substance. Thus, a therapeutic kit 100 including a container 101, such as those described herein with respect to embodiments of the present invention, can provide improved ergonomics, versatility, durability, and / or ease of use for patients and caregivers preparing and administering therapeutic agents.

[0034] Returning to a detailed discussion of the configuration of the container 101 itself, FIG. 2 is a top, front perspective view of the treatment kit 100 container 101 in a closed configuration in accordance with an embodiment of the present invention. Because the container 101 is now illustrated in a closed configuration, only the exterior surface 110 of the container 101 is visible in this view. As illustrated, the first member 102 is located in the bottom half of the container 101 when in the closed configuration. This is the same as the first member 102 illustrated as being on the left side of FIG. 1. As illustrated in FIG. 2, the third member 106 is located in the top half of the container 101 when in the closed configuration. This is the same as the third member 106 illustrated as being on the right side of FIG. 1. Because FIG. 2 is a top, front perspective view of the treatment kit 100 container 101 in a closed configuration, neither the second member 104 nor any hinge 108 are visible in this view.

[0035] As illustrated in FIG. 2, in one embodiment, the container 101 can be considered to have a front side 122 and a right side 128 that are visible in this view. The back side 124 and the left side 126 are not visible in this view. In addition, the container 101 can be considered to have a top plate 116, which is a relatively large, flat plate that forms part of the exterior surface 110 of the third member 106. In some embodiments, the container 101 can also include a release element 130 that can help transition the container 101 from a closed configuration to an open configuration, as described in more detail below. In FIG. 2, a single release element 130 is illustrated on the right side 128 of the container 101. In some embodiments, the release element 130 can be located in different locations or there can be multiple release elements 130.

[0036] 3A is a top rear perspective view of the treatment kit 100 container 101 in a closed configuration in accordance with an embodiment of the present invention. Because the container 101 is now illustrated in a closed configuration, only the exterior surface 110 of the container 101 is visible in this view. As illustrated, the first member 102 is located in the bottom half of the container 101 when in the closed configuration. This is the same as the first member 102 illustrated as being in the bottom half of the container 101 in FIG. 2, but from a different angle. As illustrated in FIG. 3A, the third member 106 is located in the top half of the container 101 when in the closed configuration. This is the same as the third member 106 illustrated as being in the top half of the container 101 in FIG. 2. Because FIG. 3A is a top rear perspective view of the treatment kit 100 container 101 in a closed configuration, both the second member 104 and the two separate hinges 108 are not visible in this view.

[0037] As illustrated in FIG. 3A, in one embodiment, the container 101 can be considered to have a rear side 124 and a left side 126 that are visible in this view. The front side 122 and the right side 128 are not visible in this view. In addition, the top plate 116 of the container 101 illustrated in FIG. 2 is also visible in this FIG. 3, but from a different angle. The top plate 116 is a relatively large, flat plate that forms part of the exterior surface 110 of the third member 106. In addition to the release element 130 on the right side 128 of the container 101 illustrated in FIG. 2, in some embodiments, the container 101 can also include a release element 130 on its left side 126, as illustrated in FIG. 3A. As described in more detail below, the release element 130 can aid in transitioning the container 101 from a closed configuration to a closed configuration.

[0038] 2 and 3A as being located on the first member 102 of the container 101, in other embodiments, one or more of the release elements 130 may instead be located on the second member 104 or the third member 106 of the container 101. In some embodiments, the container 101 may include release elements 130 on both the first member 102 and the third member 106 that are vertically aligned with one another. Another embodiment may include a release element 130 as shown in FIG.

[0039] It should also be noted that in embodiments, as illustrated in FIG. 3A, the container 101 may include one or more mating elements for mating with other containers 101 stacked above or below the container 101. For example, as illustrated in FIG. 3A, the container 101 may include a plurality of upper mating elements 132 on the exterior surface 110 of the third member 106. In embodiments, the upper mating elements 132 may be upwardly facing recesses located at or near corners of the third member 106. As described in more detail below, the upper mating elements 132 of one container 101 may mate with complementary elements of another container 101 such that multiple containers 101 may be conveniently and securely stacked for storage or transport.

[0040] 3B is a bottom view of the treatment kit 100 container 101 in a closed configuration in accordance with an embodiment of the present invention. Because the container 101 is now illustrated in a closed configuration, only the exterior surface 110 of the container 101 is visible in this view. As shown, the first member 102 is located on the bottom half of the container 101 when in the closed configuration. This is the same as the first member 102 illustrated as being on the bottom half of the container 101 in FIG. 3A, but from a different angle. Because FIG. 3B is a bottom view of the treatment kit 100 container 101 in a closed configuration, both the second member 104 and the third member 106 are not visible in this view. The hinge 108, which happens to be a living hinge 108, is visible in this view.

[0041] As illustrated in FIG. 3B, in one embodiment, the container 101 can be considered to have a bottom plate 118 that is a relatively large, flat plate that forms part of the exterior surface 110 of the first member 102. It should also be noted that in an embodiment, as illustrated in FIG. 3B, the container 101 can include one or more mating elements for mating with other containers 101 stacked above or below the container 101. For example, as illustrated in FIG. 3B, the container 101 can include a plurality of bottom mating elements 134 on the exterior surface 110 of the first member 102. In an embodiment, the bottom mating elements 134 can be downwardly facing extensions located at or near the corners of the first member 102. As described in more detail below, these bottom mating elements 134 of one container 101 can mate with complementary top mating elements 132 of another container 101, as described above with respect to FIG. 3A, so that multiple containers 101 can be conveniently and securely stacked for storage or transportation.

[0042] In some embodiments, mating elements such as top mating element 132 and bottom mating element 134 may not be present in container 101. In other embodiments, the mating elements may take on substantially different mating configurations other than recesses or extensions, or the positions of the recesses and extensions may be swapped.

[0043] Returning to a detailed illustration of the inner surface 112 of the container 101, Figure 4 is a top front perspective view of an empty treatment kit 100 container 101 in an open configuration in accordance with an embodiment of the present invention. In this view, the syringe 200, vial 300, and vial adapter 400 have been removed from the container 101.

[0044] 4, in one embodiment, the first member 102 may include several structural features designed to releasably retain the syringe 200 within the container 101. For example, the first member 102 may include one or more support walls on the inner surface 112 of the container 101. The support walls may be upwardly extending walls configured to releasably mate with the syringe 200 or a component thereof.

[0045] In one embodiment, the first member 102 may include a first support wall 142 and a second support wall 144 on the inner surface 112 of the container 101. The first support wall 142 may extend upward from the inner surface 112 of the first member 102 of the container 101 and extend from the left side 126 of the container to the right side 128 of the container. In other embodiments, the first support wall 142 may be oriented with respect to the first member 102 in a different manner or may not extend across the entire container 101 from one side to the other. In an embodiment, the wall may consist of two or more separate walls. In yet other embodiments, instead of a "wall," the support structure may be a block, a sphere, or other suitable shape of support structure.

[0046] In one embodiment, the first support wall 142 may include certain structural features that allow it to releasably mate with the syringe 200 or a component thereof. For example, in FIG. 4, the first support wall 142 includes an arcuate recess 146 and a groove 148. In other embodiments, the first support wall 142 may include additional arcuate recesses 146 and / or grooves 148, may not include these features, or may include additional structural features that allow the first support wall 142 to releasably mate with the syringe 200 or a component thereof.

[0047] The arcuate recess 146 may be a semi-circular cavity in an otherwise continuous structure of the first support wall 142 that may be configured to releasably mate with the syringe 200 barrel 202. In embodiments in which the syringe 200 barrel 202 is not cylindrical, a recess that is shaped differently than the arcuate recess 146 may be more appropriate. The size and shape of the recess may vary depending on the syringe 200 barrel 202.

[0048] The groove 148 may be a slit, thin rectangular cutout, thin triangular cutout, or other suitable cavity in an otherwise continuous structure of the first support wall 142 that may be configured to releasably mate with the syringe 200 plunger rod 204 when the plunger rod 204 is stored separate from the barrel 202. The groove 148 may be appropriate in embodiments where the syringe 200 plunger rod 204 has an "X" shaped cross section formed from four equally spaced support beams such that one of the beams may extend downwardly into the groove 148. In embodiments where the syringe 200 plunger rod 204 does not have an "X" shaped cross section, a groove 148 shaped differently than that shown in FIG. 4 may be more appropriate. The size and shape of the groove 148 may vary depending on the syringe 200 plunger rod 204.

[0049] In one embodiment, in addition to the first support wall 142, the inner surface 112 of the first member 102 of the container 101 may also include a second support wall 144. The second support wall 144 may extend upwardly from the inner surface 112 of the first member 102 of the container 101 and span from the left side 126 of the container to the right side 128 of the container. In other embodiments, the second support wall 144 may be oriented relative to the first member 102 in a different manner. In an embodiment, the first support wall 142 is located near the front side 122 of the container 101, while the second support wall 144 may be located near the back side 124 of the container 101.

[0050] In one embodiment, the second support wall 144 may include certain structural features that allow it to releasably mate with the syringe 200 or a component thereof, and optionally the vial 300 or a portion thereof. For example, in FIG. 4, the second support wall 144 includes an arcuate recess 146 and a groove 148. In other embodiments, the second support wall 144 may include additional arcuate recesses 146 and / or grooves 148, may not include these features, or may include additional structural features that allow the second support wall 144 to releasably mate with the syringe 200 or a component thereof. In an embodiment, the second support wall 144 may include an arcuate recess 146 designed to match the shape of the vial 300 when the container 101 is in a closed configuration, and the vial 300 and the second support wall 144 of the first member 102 are brought into close proximity with one another.

[0051] Similar to the arcuate recess 146 described with respect to the first support wall 142, the arcuate recess 146 of the second support wall 144 may be a semicircular cavity in an otherwise continuous structure of the second support wall 144 that may be configured to releasably mate with the syringe 200 barrel 202. In embodiments in which the syringe 200 barrel 202 is not cylindrical, a recess that is shaped differently than the arcuate recess 146 may be more appropriate. The size and shape of the recess may vary depending on the syringe 200 barrel 202.

[0052] Similar to the groove 148 described with respect to the first support wall 142, the groove 148 of the second support wall 144 may be a slit, thin rectangular incision, thin triangular incision, or other suitable cavity in an otherwise continuous structure of the second support wall 144 that may be configured to releasably mate with the syringe 200 plunger rod 204 when the plunger rod 204 is stored separate from the barrel 202. The groove 148 may be appropriate in embodiments where the syringe 200 plunger rod 204 has an "X" shaped cross section formed from four equally spaced support beams such that one of the beams may extend downwardly into the groove 148. In embodiments where the syringe 200 plunger rod 204 does not have an "X" shaped cross section, a groove 148 shaped differently than that shown in FIG. 4 may be more appropriate. The size and shape of the groove 148 may vary depending on the syringe 200 plunger rod 204.

[0053] In an embodiment of the present invention, the arcuate recesses 146 and / or grooves 148 of the first support wall 142 and the second support wall 144 may be aligned with one another such that the first member 102 can hold the syringe 200 barrel 202 and the syringe 200 plunger rod 204 in a manner that effectively utilizes the space within the container 101.

[0054] In some embodiments, the first support wall 142 and / or the second support wall 144 may include one or more other suitable cavities in addition to the groove 148. For example, FIG. 11 illustrates an embodiment in which an additional cavity or groove is shaped and positioned perpendicular to the first groove 148 such that a syringe 200 plunger rod 204 having an "X" shaped cross section formed from four equally spaced support beams can be placed into and / or held by the first support wall 142 and / or second support wall 144 material forming the additional cavity or groove. In some embodiments, the first support wall 142 and / or the second support wall 144 may include structural features designed to releasably hold the syringe 200 plunger rod 204 within the container 101, such as one or more hooks 150.

[0055] In other embodiments, first support wall 142 and / or second support wall 144 may include structural features designed to releasably retain syringe 200 barrel 202 within container 101, such as one or more hooks 150 that may be incorporated into arcuate recess 146 illustrated in FIG. 11.

[0056] 4, the first member 102 may include several additional structural features designed to releasably retain the syringe 200 within the container 101. For example, the first member 102 may also include one or more hooks 150 on the inner surface 112 of the container 101. The hooks 150 may be molded extensions or additions of the first member 102 that are bulbously curved or otherwise configured to releasably mate with the syringe 200 or a component thereof.

[0057] In one embodiment, the first member 102 may include a first support wall 142 and a second support wall 144 on the inner surface 112 of the container 101. The first support wall 142 may have one hook 150 for mating with the syringe 200 barrel 202 and another hook 150 for mating with the syringe 200 plunger rod 204. As described in further detail below, the first support wall 142 and the second support wall 144 may work in conjunction with these hooks 150 such that the syringe 200 barrel 202 and the syringe 200 plunger rod 204 may be releasably installed and removed from the container 101 by a friction fit.

[0058] In other embodiments, hooks 150 may include hinges, springs, or other structural features that may assist in their function of releasably retaining syringe 200. In still other embodiments, hinges, springs, or other structural features may be present without hooks 150.

[0059] In some embodiments, there may not be a separate hook 150. Instead, as shown in FIG. 11 , the first support wall 142 and / or the second support wall 144 may include structural features that are directly integrated into the arcuate recess 146, but are not separate hooks 150, designed to releasably retain the syringe 200 barrel 202 and / or plunger rod 204 within the container 101.

[0060] 4, in other embodiments, the second member 104 may include structural features designed to releasably retain a vial 300 or other container within the vessel 101. For example, the second member 104 may include a sleeve 152 or other structure on the inner surface 112 of the vessel 101 for releasably mating with a vial 300 or component thereof.

[0061] In various embodiments, the inner surface 112 of the second member 104 can be configured to hold the vial 300 in a variety of different orientations. For example, as illustrated in FIG. 4, the second member 104 can include a cylindrical sleeve 152 that can be adapted to releasably hold a generally cylindrically shaped vial 300. The cylindrically shaped sleeve 152 can be best suited to releasably hold a vial by its cap 302 or base 304, as these structures can fit snugly within the cylindrically shaped sleeve 152. In other embodiments, the sleeve 152 can take on other shapes as needed to hold the vial 300 on its side.

[0062] In embodiments in which the vial 300 is not cylindrical, a sleeve 152 shaped differently than the sleeve 152 of Figure 4 may be more appropriate. The size and shape of the sleeve 152 may vary depending on the vial 300. Additionally, in other embodiments, means other than the sleeve 152 may be used to secure the vial. For example, adhesives, hook and look fasteners, snaps, slots, or other means may be used.

[0063] 4, the sleeve 152 includes four upwardly extending walls that are equally spaced and define four equally spaced cavities. The sleeve 152 may form a generally cylindrical shape, a generally frusto-conical shape, or other suitable shape. In some embodiments, the sleeve 152 may include fewer or more than three upwardly extending walls and cavities. The sleeve 152 may be centered or off-center on the inner surface 112 of the second member 104.

[0064] 4, in other embodiments, third member 106 may include structural features designed to releasably retain vial adapter 400 within container 101. In some embodiments, vial adapter 400 may have a skirt 404 at its base. Accordingly, third member 106 may include one or more slots 154 and / or guides 156 on inner surface 112 of container 101 for contacting vial adapter 400 skirt 404.

[0065] As shown in FIG. 4, the slots 154 may consist of relatively short rails or tabs extending from the bottom and / or sidewalls of the third member 106. As described in further detail below with reference to other figures, it may be possible to slide or flex and insert the skirt 404 of the vial adapter 400, or a portion thereof, under one or more of the slots 154 to releasably secure the vial adapter 400 to the container 101. FIG. 4 shows one slot 154 extending from the sidewall of the left side 126 of the third member 106 and one slot 154 extending from the right side of the bottom of the third member 106. In other embodiments, fewer or more than two slots 154 are employed, or slots may be omitted entirely.

[0066] As further shown in FIG. 4, the guide 156 may consist of a relatively small ridge extending upward from the bottom surface of the third member 106. In combination with one or more slots 154, it may be possible to slide or flex and insert the skirt 404 of the vial adapter 400, or a portion thereof, over or across the one or more guides 156 to releasably secure the vial adapter 400 to the container 101, as will be described in more detail below with reference to other figures. FIG. 4 shows one guide 156 protrusion extending from the bottom surface of the third member 106 toward the left side 126 of the third member 106, and another guide 156 protrusion extending from the bottom surface of the third member 106 toward the right side 128 of the third member 106. In other embodiments, fewer or more than two guides 156 are employed, or the guide 156 may be omitted entirely. In some embodiments, the guide 156 may take other configurations other than a small protrusion.

[0067] FIG. 4 also illustrates example components of the container 101 that may aid in transitioning the container 101 from an open configuration to a closed configuration and vice versa.

[0068] In one embodiment, a continuous two-tiered edge 138 spans across the top of the sidewall of the first member 102 of the container 101. In the embodiment shown, there is a discontinuity in this bottom edge 138 where there is also a discontinuity in the sidewall as needed to accommodate the second member 104 when the container 101 is in its closed configuration.

[0069] In addition, there may be a complementary continuous two-step edge 136 that extends across the top of the sidewall of the third member 106 of the container 101. In the illustrated embodiment, there is a discontinuity in this top edge 136 where there is also a discontinuity in the sidewall as needed to accommodate the second member 104 when the container 101 is in its closed configuration.

[0070] The bottom edge 138 and the top edge 136 may interlock by mating when the container 101 is moved to its closed configuration, in which a double-step arrangement on one edge matches an opposing double-step arrangement on the other edge to create a closed seal.

[0071] In some embodiments of the invention, this closed seal may be locked against unintentional opening by one or more closure elements 140. The closure elements 140 may be any suitable locking means of varying levels of complexity. In one embodiment, as illustrated in FIG. 4, the closure elements 140 may consist of snap-fit ​​elements. A snap-fit ​​is a mechanical joining system in which attachment between parts may be achieved by locking features that are homogenous to one or the other of the components being joined. The join requires a flexible locking feature that moves laterally to engage the mating parts and then returns the locking feature to its original position to achieve the interference required to fasten the components together.

[0072] In one embodiment, the snap-fit ​​closure element 140 may include one or more locking protrusions on the bottom edge 138 of the first member 102 and corresponding mating locking recesses on the top edge 136 of the third member 106. When the container 101 is manipulated from its open configuration to its closed configuration, the top edge 136 of the third member 106 may be moved to the bottom edge 138 of the first member 102 such that the locking recesses of the top edge 136 slide over the locking protrusions of the bottom edge 138, thus locking the third member 106 in place relative to the first member 102.

[0073] In some embodiments, the container 101 may also include a release element 130 that may help transition the container 101 from a closed configuration to a closed configuration, such as the release element 130 shown in FIG. 2 and FIG. 3A. More specifically, the left side 126 and the right side 128 of the first member 102 may each have a release element 130 in the form of a spherical depression located just below a locking protrusion on the bottom edge 138 of the exterior surface 110 of the container 101. An exemplary release element 130 can be seen in FIG. 4. To release the locking mechanism, a user may apply pressure to one or more of the release elements 130, which may cause the sidewall and bottom edge 138 of the first member 102 to bend slightly inward. This inward bending may pull the locking protrusion on the bottom edge 138 out of the locking configuration with the locking recess on the top edge 136. Thus, the first member 102 and the third member 106 are released from each other, and the container 101 may be manipulated into the open configuration.

[0074] Other embodiments may employ other types of locking mechanisms employing separate closure elements 140 and release elements 130. In some embodiments, fewer or more than two sets of closure elements 140 and release elements 130 are employed, and in some embodiments, closure elements 140 and release elements 130 may not be used at all.

[0075] 5-7 illustrate various views of a treatment kit container in an open configuration including various components stored within the container in accordance with an embodiment of the present invention.

[0076] 5 is a top, front perspective view of a treatment kit container in an open configuration including various components according to an embodiment of the present invention. FIG 5 illustrates a view similar to that of FIG 4, except that syringe 200, vial 300, and vial adapter 400 are in place in the container in FIG 5.

[0077] As particularly illustrated in Figures 5 and 6, in an embodiment of the present invention, the first support wall 142 and the second support wall 144 of the first member 102 may work in conjunction with two hooks 150 of the first member 102 to releasably hold the syringe 200 barrel 202 and the syringe 200 plunger rod 204 in place via a friction fit.

[0078] Specifically, the syringe 200 barrel 202 and the syringe 200 plunger rod 204 may be placed within the first member 102 of the container 101 by applying downward pressure to the barrel 202 and plunger rod 204 such that they are approximately in a fixed position and the hooks 150 are temporarily bent, misaligned, or otherwise temporarily disengaged while the barrel 202 and plunger rod 204 move into position. Eventually, the hooks 150 have the freedom of movement to realign to (or near) their original position to achieve the required interference to releasably hold the barrel 202 and plunger rod 204 in place.

[0079] 5, in some embodiments, the first member 102 may be configured with an open space for accommodating the backstop 206 (or finger flange) and hub 208 of the barrel 202 of the syringe 200, and an open space for accommodating the head 210 of the plunger rod 204 of the syringe 200. In other embodiments, the first member 102 may be specifically configured with specific components (e.g., with additional support walls, hooks, or other structural elements) for coupling to the backstop 206, hub 208, and / or head 210 of the syringe 200.

[0080] When it is desired to remove the barrel 202 and plunger rod 104 from the first member 102, upward pressure may be applied to the barrel 202 and plunger rod 104 such that the hooks 150 are temporarily bent, misaligned, or otherwise temporarily disengaged while the barrel 202 and plunger rod 204 are withdrawn from the first member 102. Eventually, the hooks 150 have the freedom of movement to realign to (or near) their original position.

[0081] As illustrated in FIGS. 5-7, in embodiments of the invention, the sleeve 152 of the second member 104 may be configured to releasably retain a vial 300 or other container within the vessel 101. The second member 104 may include a cylindrically or generally frusto-conically shaped sleeve 152 that may be suitable for releasably retaining a generally cylindrically shaped vial 300. In the embodiment shown in FIG. 6, the sleeve 152 includes four upwardly extending walls that are equally spaced and define four equally spaced cavities. In some embodiments, the sleeve 152 may include fewer or more than three upwardly extending walls and cavities. The sleeve 152 may be centered or off-center on the inner surface 112 of the second member 104.

[0082] With this exemplary configuration of sleeve 152, in embodiments, the sleeve may be configured to releasably hold vial 200 by its base 304, as best illustrated in Figure 7. In this manner, the vial 300 is held upright, with its base 304 securely gripped by sleeve 152, and its cap 302 presented upwardly and away from second member 104. The four walls of sleeve 152 may work in concert to hold vial 200 by its base 304 through a friction fit.

[0083] Specifically, the vial 300 may be placed in the second member 104 of the container 101 by placing the vial 300 approximately in position and applying downward pressure to the sleeve 152 such that the four walls of the sleeve 152 deform slightly outward while the vial 300 moves into position. In some embodiments, a generally cylindrically shaped sleeve 152 may apply pressure relatively evenly along the height of the base 304 of the vial 300, while a generally frusto-conical shaped sleeve 152 that tapers upwardly may provide slightly more pressure at the higher point of the base 304 of the vial 300.

[0084] As illustrated in Figures 5-6, in an embodiment of the invention, slots 154 and guides 156 of third member 106 may be configured to releasably retain vial adapter 400 within container 101. As illustrated in Figure 6, slots 154 may consist of relatively short rails or tabs extending from the bottom and / or sidewalls of third member 106. As seen in Figure 6, skirt 404 of vial adapter 400, or a portion thereof, may be able to be slid or bent and inserted under one or more slots 154 to releasably secure vial adapter 400 to container 101.

[0085] 6, guide 156 may consist of a relatively small ridge extending upwardly from a bottom surface of third member 106. In embodiments, in combination with one or more slots 154, skirt 404 of vial adapter 400, or a portion thereof, may be capable of being slid or flexed and inserted over or across one or more guides 156 to releasably secure vial adapter 400 to container 101 via a friction fit.

[0086] Specifically, the vial adapter 400 may be slid or placed into the third member 106 of the container 101 by placing the vial adapter 400 approximately in position and applying a sliding pressure to the skirt of the vial adapter 400 so that it flexes and passes through the guide 156 protrusions, or by applying pressure to the flexible skirt 404 of the vial adapter 400 so that the end of the flexible skirt 404 is temporarily bent or folded until it fits under the slot 154.

[0087] Treatment kits 100 including containers 101, such as those described herein with respect to embodiments of the present invention, provide improved ergonomics, versatility, durability, and / or ease of use for patients and caregivers to prepare and administer therapeutic agents. In some embodiments, containers 101, optionally including first member 102, second member 104, and third member 106, can be manipulated in a variety of ways between open and closed configurations to optimally conceal and present their contents to the user.

[0088] In one embodiment, the container 101 is configured such that when in a closed configuration, as illustrated in FIG. 2, the outer surfaces 110 of the first member 102 and the third member 106 are approximately parallel to each other and face in opposite directions, but when in an open configuration, as illustrated in FIG. 4, the outer surfaces 110 of the first member 102, the second member 104, and the third member 106 are approximately parallel to each other and face in the same direction.

[0089] In another embodiment, the container 101 may be configured such that when in the closed configuration, the top plate of the third member 106 and the bottom plate of the first member 102 are substantially parallel to one another and a side plate, such as a side plate of the second member 104, is substantially perpendicular to the top and bottom plates. The container 101 may be further configured such that when in the closed configuration, the side plates are configured to releasably hold the vial 300 such that the longitudinal axis of the vial 300 (i.e., the axis running through the center of the vial 300 between its cap 302 and its base 304) is substantially parallel to the top and bottom plates.

[0090] In yet another embodiment, the container 101 may be configured such that when in a closed configuration, the longitudinal axis of the syringe 200 barrel 202 (i.e., the axis running through the center of the syringe 200 barrel 202 between its backstop 206 and its hub 208) is approximately parallel to the longitudinal axis of the vial 300, and when in an open configuration, the longitudinal axis of the syringe 200 barrel 202 is approximately perpendicular to the longitudinal axis of the vial 300.

[0091] Figure 7 is a right side view of treatment kit container 101 in an open configuration including disassembled syringe 200, vial 300, and vial adapter 400 in accordance with an embodiment of the present invention. Conversely, Figure 8 is a right side view of treatment kit container 101 in an open configuration including a together assembled syringe 200, vial 300, and vial adapter 400 in accordance with an embodiment of the present invention.

[0092] As previously discussed, preparing a therapeutic solution and administering it to an individual often involves mixing two or more drugs or other substances to form a therapeutic solution and then delivering the mixed therapeutic solution to the individual. Mixing drugs or other substances often involves extracting one drug or other substance in liquid form from a vial 300 or other container and transferring the drug or other substance to a separate container, e.g., syringe 200, that holds the other drug or substance.

[0093] 8, in an embodiment of the present invention, it may be desirable to connect a syringe 200, a vial 300, and a vial adapter 400 to prepare a therapeutic solution. In one embodiment, the syringe 200 plunger rod 204 is inserted and locked into the syringe 200 barrel 202 while the skirt 404 of the vial adapter 400 rests on the outer edge of the vial 300 cap 302, the hub 208 of the syringe 200 barrel 202 is attached to the connector 402 of the vial adapter 400, and an inner needle (not shown) of the vial adapter 400 may pierce the cap 302 of the vial 300.

[0094] An exemplary method for connecting the syringe 200, the vial 300, and the vial adapter 400 to prepare a therapeutic solution for injection is now described, however, various other methods and sequences of steps may alternatively be used to accomplish preparation of the therapeutic solution.

[0095] First, the user opens the container 101 so that the second member 104 is laid flat on the preparation surface and the top of the cap 302 of the vial 300 is presented facing up. Next, the user removes the vial adapter 400 from the third member 106 of the container 101 by sliding the vial adapter 400 out of the slot 154 of the other releasable retention mechanism. The user then places the vial adapter 400 on top of the cap 302 of the vial 300 and pushes the vial adapter 400 downwards so that the inner needle (not shown) of the vial adapter 400 may penetrate the cap 302 of the vial 300. In other embodiments, the vial adapter 400 and the vial 300 may be connected by mechanisms other than having the inner needle of the vial adapter 400 penetrate the cap 302 of the vial 300. For example, the vial adapter 400 may include a fastening mechanism that can mate with a matching fastening mechanism of the cap 302 of the vial 300. Suitable fastening mechanisms may include, for example, a plastic luer lock, or other suitable threaded, friction fit, or other fastening means.

[0096] The user can then remove the barrel 202 and plunger rod 204 of the syringe 200 from the first member 102 of the container 101 by releasing them from the first support wall 142, the second support wall 144, the hook 150, or other releasable retention mechanism. The user can then assemble the barrel 202 and plunger rod 204 of the syringe 200 together to form the complete syringe 200. At this point, the user can connect the syringe 200 to the vial adapter 400 by connecting the syringe 200 hub 208 to the vial adapter connector 402. The vial adapter connector 402 and / or the syringe hub 208 can include fastening mechanisms that can mate with each other's matching fastening mechanisms. Suitable fastening mechanisms can include, for example, a plastic luer lock, luer cone, luer slip, or other suitable threaded, friction fit, or other fastening means.

[0097] As illustrated in FIG. 8 and described above, assembling the syringe 200, vial adapter 400, and vial 300 into a long continuous structure can be difficult for patients and caregivers. Some individuals prefer to attempt to assemble the structure in an upright fashion, with the head 210 of the syringe 200 plunger rod 204 pointing up and the base of the vial 300 on a horizontal surface, such as the top of a table. However, this arrangement can be very unstable and prone to toppling over with even the slightest environmental disturbance, such as a slight vibration or movement of the table on which the arrangement is stacked. The point at which the user presses the vial adapter 400 down so that the inner needle of the vial adapter 400 penetrates the cap 302 of the vial 300 is particularly unstable, as the entire device can topple over if it is not stable. Similar potential instability can also occur when the user connects the syringe 200 to the vial adapter 400 by connecting the syringe 200 hub 208 to the vial adapter's connector 402. Additionally, as material is drawn from the vial 300 into the syringe 200, the array becomes top heavy and therefore more unstable.

[0098] In accordance with embodiments of the present invention, these problems can be solved by configuring container 101 such that the patient or caregiver can assemble syringe 200, vial adapter 400, and vial 300 together while these elements are supported by container 101 itself. This can be accomplished by building a sequential configuration of elements starting with vial 300, which can be removably secured by container 101.

[0099] Further, in accordance with an embodiment of the present invention, container 101 may be configured such that base 304 of vial 300 may be removably secured to container 101 while at the same time, vial cap 302 is presented in an upward direction and is free to be engaged by vial adapter 400, while base 304 of vial 300 is still held in place.

[0100] Additionally, in accordance with an embodiment of the present invention, container 101 can secure vial 300 such that when container 101 is manipulated from its closed configuration to its open configuration, vial 300 does not have to be moved or otherwise reoriented, but is automatically in the proper position to be engaged by vial adapter 400. In this manner, cap 302 of vial 300 can be presented in an upward direction when in the open configuration, regardless of how vial 300 is oriented during storage.

[0101] As noted above, in embodiments employing first member 102, second member 104, and third member 106, the container 101 arrangement may provide a further advantage in that the supporting fist members 102 and third member 106 may provide a broad, stable base based on the central second member 102 including sleeve 152, which serves as a base for the vial 300. As illustrated in FIG. 8, in this configuration, forces acting on the syringe 200, vial adapter 400, and vial 300 arrangement may cause it to become unstable (illustrated by the curved arrows), but the stable base provided by the interconnected first member 102, second member 104, and third member 106 may be able to withstand such forces.

[0102] In some embodiments of the invention, portions of the first member 102, second member 104, and / or third member 106 that may contact a work surface (such as a table) during assembly may be specially adapted to increase friction between the container 101 and the work surface to further stabilize the arrangement. For example, in some embodiments, increased texture may be provided by using materials such as rubber, or by knurling, tapping, or adding indentations, ridges, or other textured surface elements.

[0103] Thus, such a container 101 configuration may provide improved ergonomics, versatility, durability, and / or ease of use.

[0104] 4, in some embodiments, when the vial adapter 400 is removed from the third member 106 for installation into the cap 302 of a vial, the inner surface 112 of the third member 106 essentially becomes an open, sterile work area. This open space can be advantageously used as a work or staging area for temporarily setting up or storing the syringe 200, the stored vial adapter 400, or other accessory elements (e.g., instructions, an injection needle set, an alcohol swab, a gauze pad, or a band-aid) while preparing an injection.

[0105] In some embodiments of the invention, when a user has completed using an element of treatment kit 100 container 101 for their intended purpose (e.g., administering an injection), the element may be returned to container 101 for disposal. In embodiments in which container 101 is made from a durable material, such as durable polypropylene, and has a suitable closure mechanism, such as closure element 140, container 101 may serve as a durable and secure means for placing potentially dangerous and / or harmful items, such as the needle of syringe 200.

[0106] 9A and 9B, when in their closed configuration, containers 101 according to embodiments of the present invention may be stacked and stored in large quantities due to their ergonomic features and compact size.

[0107] 9A, a first container 101 is stacked on top of a second container 101. As explained above, the upper container 101 can include a plurality of bottom mating elements 134 on the exterior surface 110 of its first member 102, while the lower container 101 can include a plurality of top mating elements 132 on the exterior surface 110 of its third member 106. The bottom mating elements 134 of one container 101 can mate with complementary top mating elements 132 of the other container 101 such that multiple containers 101 can be conveniently and securely stacked for storage or transportation.

[0108] 9B illustrates 48 individual containers 101 stacked on top of one another. Certain diseases or medical conditions may require the administration of medications that are stable for a significant period of time only while refrigerated. To the extent that these same diseases or medical conditions may require frequent (e.g., daily) dosages, being able to store large quantities of medication under refrigeration so that multiple trips to drug vendors are not necessary may be important to patients and caregivers. Typical limited refrigeration environments may include, for example, a home refrigerator, a dormitory refrigerator, or a hospital refrigerator.

[0109] To the extent that such drugs are most conveniently distributed and used as part of a treatment kit 100, the containers 101 of such kits 100 should be as small and easily stackable as possible. Thus, containers 100 according to the embodiments of the present invention described above, having relatively compact dimensions in addition to convenient ergonomic stacking features, can provide an advantage to patients or caregivers with bulk storage needs.

[0110] In some embodiments, for example for use with drugs, such as drugs that require refrigeration to maintain stability, it may be desirable to increase the level of insulation of the container 101. In this way, the container (and the drug held therein) will remain cooler longer in warm environments, even when the user carries the container 101 when traveling in unrefrigerated luggage, such as a backpack, purse, diaper bag, or luggage. In one embodiment, the container 101 is insulated by thickening the walls of the container 101, which comprise the first member 102, the second member 104, and the third member 106. In another embodiment, the container 101 is insulated by applying an additional layer of insulation to the container 101, such as, for example, a layer made of mineral wool, glass wool, flexible elastic foam, rigid foam, polyethylene, silica aerogel insulation, or an air bladder filled with a gas or liquid, such as air or water.

[0111] FIG. 10 is a top front perspective view of a treatment kit 100 container 101 in an open configuration including various components according to an alternative embodiment of the present invention.

[0112] It should be noted that in contrast to the interior surface 112 of the treatment kit 100 container 101 illustrated in Figures 1 and 4-6, this alternative container 101 is configured to store some of the syringes 200, vials 300, and vial adapters 400 previously described above in different locations. Specifically, in the embodiment of Figure 10, in addition to the vial 300, the syringe 200 barrel 202 and syringe plunger rod 204 are both releasably secured to the central second member 104 of the container 101. Thus, one of the first member 102 and the third member 106 is left to house the vial adapter 400, while the other of these members is left as an open, sterile work area. This work area can be advantageously used to temporarily set up or store the syringe 200, the stored vial adapter 400, or other accessory elements (e.g., instructions, an injection needle set, an alcohol swab, a gauze pad, or a band-aid) while preparing an injection.

[0113] While the medical components potentially housed by container 101 in accordance with the embodiments of the invention detailed herein have primarily been syringe 200, vial 300, and vial adapters, in other embodiments container 101 may be configured to store and / or releasably hold product instructions, an injection needle set, alcohol swabs, gauze pads, or band-aids. In some embodiments, these accessory elements may alternatively be stored and / or held in a larger outer container that may be used to store and protect container 101 at various points during manufacture, distribution, sale, and / or use.

[0114] In other embodiments, a single container 101 may be configured to hold multiple syringes 200, multiple vials 300, and / or multiple vial adapters. In various embodiments, the second member 104 may be configured to hold one, two, three, four, five or more vials 300.

[0115] In addition, although exemplary embodiments of the present invention have been described as releasably retaining certain components on either the first member 102, the second member 104, or the third member 106 of the container, the present invention need not be so limited. In some embodiments, the syringe 200 may be releasably retained by either the first member 102, the second member 104, or the third member 106, the vial 300 may be retained by either the first member 102, the second member 104, or the third member 106, and the vial adapter 400 may be retained by either the first member 102, the second member 104, or the third member 106. In embodiments, each of the syringe 200, the vial 300, and the vial adapter 400 may be releasably retained only by one of the first member 102, the second member 104, or the third member 106.

[0116] Additionally, although many of the exemplary embodiments of the present invention are described in the context of a container 101 having a first member 102, a second member 104, or a third member 106, a container 101 according to other embodiments of the present invention may have fewer or more than three members.

[0117] In some embodiments of the present invention, different kits 100 and / or containers 101 may be designed for different therapeutic agents or doses thereof. For example, a particular container 101 may hold therapeutic agents having different concentrations, volumes, and / or strengths. In embodiments, a portion of each container 101 may be colored a particular color, and the container 101 is color coded to indicate the type of therapeutic agent and / or dose of therapeutic agent it contains.

[0118] In another embodiment of the invention, a portion of the kit 100 and / or container 101 may include a portion having labeling of the product. Labeling may be included by adding a label sticker or by printing, engraving, molding, or otherwise forming labeling into a portion of the kit 100 and / or container 101. In some embodiments, the kit 100 and / or container 101 are labeled to indicate the type and / or dosage of therapeutic agent they contain. In some embodiments, the labeling may be part of a larger outer container for containing the container 101, a sleeve surrounding the container 101, or other suitable means.

[0119] As previously mentioned, treatment kit 100 may be sold for a wide variety of medications. In one embodiment of the present invention, treatment kit 100 container 101 is configured for use in a hemophilia treatment kit.

[0120] Hemophilia is one of the most common inherited blood clotting disorders in the world. It results in reduced in vivo and in vitro blood clotting activity and requires extensive medical monitoring throughout the life of the affected individual. In the absence of intervention, affected individuals suffer from spontaneous bleeding that often results in serious medical complications. In hemophilia, clotting is disturbed by the absence of certain plasma clotting factors. For example, hemophilia A is caused by a deficiency of factor VIII (FVIII), while hemophilia B is caused by a deficiency of factor IX (FIX). Each of these forms of hemophilia can result from either a reduced synthesis of the relevant blood clotting factor protein (e.g., FVIII or FIX) or a defective blood clotting factor protein with reduced activity.

[0121] Treatment of hemophilia occurs by replacing missing blood clotting factor proteins with exogenous factor concentrates that are highly enriched in the missing clotting factor. The required blood clotting factor proteins are typically administered to individuals affected with hemophilia via intravenous injections at least several times per week using syringe 200. While some affected individuals are able to receive injections from a caregiver, many individuals choose to self-administer the injections, often for reasons of cost and convenience.

[0122] Because individuals affected with hemophilia are highly susceptible to unexpected bleeding in everyday situations, stress points on tools (e.g., container 101), stress points created by environmental surfaces (e.g., table surfaces or edges), and stresses due to unnatural body movements have the potential to cause microbleeding when individuals come into contact with tools in their environment. In the case of routine injections, treatment kit 100 has the potential to minimize microbleeding or other damage to individuals, especially for affected individuals who self-administer treatments, with even small favorable variations in container 101 configuration and the actions required to manipulate container 101 and assemble its contents.

[0123] Thus, treatment kit 100 containers 101 that offer improved ergonomics, versatility, durability, and / or ease of use in accordance with embodiments of the present invention can provide advantages to patients or caregivers administering hemophilia treatment.

[0124] Due to the advantages of the treatment kit 100 containers 101 according to embodiments of the present invention, these containers may be equally suitable for administration of other medications for patients or caregivers with similar requirements (i.e., ergonomics, versatility, durability, and / or ease of use), such as, for example, arthritis patients.

[0125] While this discussion focuses primarily on the treatment kit 100 container 101, it should be noted that some embodiments of the device containers described herein need not be limited to use with treatment kits, but may be suitable for storing items for a variety of non-therapeutic and non-medical purposes.

[0126] The present invention has been described above as an exemplary embodiment. Thus, the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.

Claims

1. 1. A medical device kit container comprising: a first member configured to releasably retain a syringe barrel; a second member having an inner surface configured to releasably hold a vial having a cap, the second member being connected to the first member by a first hinge; a third member configured to releasably hold a vial adapter, the third member coupled to the second member by a second hinge; Equipped with the first member comprises an inner surface, a first support wall, and a second support wall, each of the first and second support walls extending upwardly from the inner surface of the first member, each of the first and second support walls comprising first and second structural features; the first structural features of the first and second support walls are aligned with one another such that the syringe barrel may be releasably engaged with the first and second support walls of the first member; the second structural features of the first and second support walls are aligned with one another such that a syringe plunger rod may be releasably engaged with the first and second support walls of the first member; and the first structural feature of each of the first and second support walls is an arcuate recess for releasably mating with the syringe barrel, and the second structural feature of each of the first and second support walls is a groove for releasably mating with the syringe plunger rod, the syringe barrel and the syringe plunger rod being stored separately relative to the first member; a second member having an inner surface, comprising a plurality of walls and a plurality of cavities, and configured to releasably retain a vial at its base by a sleeve contained on and extending upwardly from said inner surface; a third member having one or more slots configured to releasably retain a vial adapter, said third member being coupled to the second member by a second hinge; The container includes a vial base that is comprised of a plurality of walls and a plurality of cavities and is held in place by a sleeve that is contained on and extends upwardly from the inner surface of the second member. The medical device kit container is configured such that when the syringe barrel is coupled to the cap of the vial while being releasably held, bottom surfaces of the first, second, and third members lie parallel to a preparation surface.

2. The medical device kit container of claim 1 , wherein the slot of the third member extends from a bottom surface of the third member.

3. The medical device kit container of claim 1 or 2, wherein the slot of the third member extends from a side of the third member.

4. The medical device kit container of any one of claims 1 to 3, wherein the third member includes two slots configured to releasably retain a vial adapter.

5. The medical device kit container of any one of claims 1 to 4, wherein the third member further comprises one or more guides extending upwardly from a bottom surface of the third member.

6. The medical device kit container of claim 5 , wherein the third member includes two guides.

7. The medical device kit container of any one of claims 1 to 6, wherein the first, second, and third members are formed as a unitary structure.

8. 8. The medical device kit container of any one of claims 1 to 7, wherein the container has a closed configuration and an open configuration; the container is configured such that in the closed configuration, outer surfaces of the first and third members are generally parallel to one another and face away from one another; and The medical device kit container is configured such that when the container is in the open configuration and placed parallel to a preparation surface, the outer surfaces of the first, second, and third members are generally parallel to each other and face in the same direction.

9. 7. The medical device kit container of claim 1, wherein the first member is configured to releasably retain the syringe barrel in the first structural feature of the first and second support walls via a friction fit.

10. The medical device kit container of any one of claims 1 to 6, wherein the first, second and third members are formed by an injection molding process.

Citation Information

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