Device and packaging system for transporting medical devices
By designing a plate device with curved edges and protruding structures with a curvature radius ranging from 0.03mm to 1mm, the problem of particle generation during the transportation of medical containers was solved, ensuring the cleanliness and sterility of the containers and achieving efficient transportation without additional cleaning steps.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-08-29
- Publication Date
- 2026-03-27
AI Technical Summary
During long-distance transportation of medical containers, friction between the device and the packaging can cause the generation of material particles, affecting the sterility of the container. Therefore, a packaging solution is needed to prevent particle generation.
Design a plate device with curved upper and lower edges, with a curvature radius in the range of 0.03 mm to 1 mm, formed by injection molding, combined with a protruding structure to reduce friction with the packaging and reduce particle generation.
It effectively prevents the generation of particles inside the packaging during transportation, ensuring that medical containers remain clean and sterile upon arrival at their destination, thus avoiding additional cleaning steps.
Smart Images
Figure CN121752310A_ABST
Abstract
Description
Technical Field
[0001] The present invention generally relates to an apparatus for transporting medical containers such as syringes and their components (e.g., stoppers), and related containers in which a receiving plate is disposed. Background Technology
[0002] Medical containers, such as prefillable or pre-filled syringes, vials, and ampoules, and components used with these containers, such as stoppers, can be transported from one location to another. For example, a medical container can be transported from its manufacturing location to a location where it can be filled with pharmaceutical fluids. As another example, medical containers can be manufactured and filled at the same location and then transported to a storage location in sterile packaging. During transport, the medical container can be supported by a retaining device, which can be a nest. One or more retaining devices can be arranged within a package with an opening that allows the retaining device to be placed therein, subsequently sealed by a sealing cap. The container can be referred to as a barrel.
[0003] For ease of assembly, the external dimensions of the retaining device are slightly smaller than the internal dimensions of the packaging. During transport, the retaining device may easily move relative to the packaging. Due to this movement during long-distance transport, the retaining device rubs against the inner surface of the packaging, potentially abrading the material of the packaging or retaining device, resulting in particles of packaging and / or retaining device material. Because the packaging is sealed with a cap, these particles remain inside the packaging for the remainder of transport and storage. These particles may disperse within the packaging, thus settling inside or on the medical container stored within it. When the medical container arrives at its destination, it is intended to be ready for immediate use. As a non-limiting example, when the medical container is a pre-fillable syringe, the syringe is intended to be clean and sterile upon arrival at the filling location, allowing it to be filled with a pharmaceutical fluid. If particles of packaging and / or retaining device material are dispersed inside or on the syringe, the syringe is not ready for immediate use and must be cleaned before filling to avoid contaminating the pharmaceutical fluid to be filled into the medical container. Therefore, a packaging solution is needed that inhibits or completely prevents the generation of particles within the packaging. Summary of the Invention
[0004] The purpose of this disclosure is to provide an apparatus for receiving a medical container or a component of a medical container, thereby overcoming the aforementioned deficiencies. The apparatus includes:
[0005] A plate having an upper surface, a lower surface, and sidewalls extending between the upper and lower surfaces, the plate defining a plurality of openings extending from the upper surface through the plate to the lower surface, each opening configured to retain a medical container or medical container component therein.
[0006] The sidewall is connected to the upper surface at its upper edge and to the lower surface at its lower edge. The upper edge, lower edge, and sidewall define the outer perimeter of the plate.
[0007] Wherein, at least a portion of the upper edge and at least a portion of the lower edge are curved surfaces, and
[0008] The radius of curvature of the surface is in the range of 0.03 mm to 1 mm.
[0009] Some preferred but non-limiting features of the above-described device are as follows, which may be used alone or in combination:
[0010] The upper and lower edges are curved surfaces;
[0011] The radius of curvature of the surface is in the range of 0.03 mm to 1 mm, preferably about 0.3 mm;
[0012] The plate includes a plurality of protrusions, each of which defines a portion of the upper surface, lower surface, sidewall, upper edge, and lower edge of the plate, and a small portion of the periphery of the plate is defined by the plurality of protrusions;
[0013] Most of the upper and lower edges of the outer perimeter of the limiting plate are straight edges.
[0014] Another object of this disclosure is a packaging system comprising:
[0015] The apparatus as described above; and
[0016] A barrel having multiple sidewalls, each sidewall having an inner surface defining a space configured to receive a plate therein.
[0017] When the device is placed in a barrel, the curved surfaces of the upper and / or lower edges contact the inner surface of the barrel.
[0018] Another object of this disclosure is a method for forming the apparatus as described above. The method includes:
[0019] The polymer material of the plate is injected into a mold, the mold comprising a fixed part and at least one movable part.
[0020] The at least one movable part and the fixed part together define a mold cavity to form a plate.
[0021] The at least one movable portion and the fixed portion have curved surfaces configured to form the upper edge and the lower edge defined by each of the plurality of protrusions.
[0022] Some preferred but non-limiting features of the above method are as follows, which may be used alone or in combination:
[0023] The fixing portion is shaped to form an upper edge, a lower edge, and a sidewall defined by each of the plurality of protrusions.
[0024] The at least one movable portion is shaped to form a portion of the upper surface defined by each of the plurality of protrusions of the plate, and
[0025] The fixed portion includes a curved surface configured to form a curved surface at an upper edge and a lower edge defined by each of the plurality of protrusions;
[0026] The parting line of the fixed part and the at least one movable part extends together with the upper surface of the plate;
[0027] The fixing portion is shaped to form an upper surface and an upper edge defined by the plurality of protrusions.
[0028] The at least one movable portion is shaped to form the lower edge, sidewalls, and lower surface of the plate defined by the plurality of protrusions, and
[0029] The at least one movable portion includes a curved surface configured to form a lower edge portion defined by the plurality of protrusions;
[0030] The parting line of the fixed part and the at least one movable part extends together with the upper surface of the plate;
[0031] The fixing portion is shaped to form a portion of an upper surface, an upper edge, and a sidewall defined by each of the plurality of protrusions.
[0032] The at least one movable portion is shaped to form a lower edge, a portion of the lower surface, and a portion of the sidewall defined by each of the plurality of protrusions, and
[0033] Each of the fixed portion and the at least one movable portion includes a curved surface to form a curved surface defined by an upper edge and a lower edge of each of the plurality of protrusions;
[0034] The parting line of the fixed part and the at least one movable part is positioned along the sidewall between the upper and lower surfaces of the plate;
[0035] The at least one movable part includes a slider and a movable part (202).
[0036] The slider is shaped to form a portion of an upper edge, a sidewall, and a lower edge defined by each of the plurality of protrusions, and
[0037] The slider includes a curved surface to form an upper edge and a lower edge defined by each of the plurality of protrusions;
[0038] The parting line of the slider and the movable part is positioned along the upper surface of the plate, and the parting line of the slider and the fixed part is positioned along the lower surface of the plate. Attached Figure Description
[0039] The illustrations presented herein are not intended to be actual views of any particular component, device, or system, but are merely idealized representations for illustrating embodiments of the invention. Other features, objectives, and advantages of the invention will become more apparent upon reading the following detailed description and with reference to the accompanying drawings, which are provided by way of non-limiting example, wherein:
[0040] Figure 1 and Figure 2 This is a view of the plate used in the packaging system;
[0041] Figure 3 This is a view of the barrels used in the packaging system;
[0042] Figure 4 This is a top view of the packaging system;
[0043] Figure 5A and Figure 5B The mold for the plate according to the first embodiment is shown during the injection of polymer material and during the ejection of the plate from the mold, respectively;
[0044] Figure 6A and Figure 6B The mold for the plate according to the second embodiment is shown during the injection of polymer material and during the removal of the plate from the mold, respectively;
[0045] Figure 7A and Figure 7B The mold for the plate according to the third embodiment is shown during the injection of polymer material and during the removal of the plate from the mold, respectively;
[0046] Figure 8A and Figure 8B The mold for the plate according to the second embodiment is shown during the injection of polymer material and during the removal of the plate from the mold. Detailed Implementation
[0047] As used herein, relative terms such as “first,” “second,” “top,” “bottom,” “upper,” “lower,” “above,” “below,” “over,” “inner,” “outer,” and similar terms are used to clearly and conveniently understand this disclosure and the accompanying drawings, and do not imply or depend on any particular preference, orientation, or order unless the context clearly indicates otherwise.
[0048] As used herein, the term “and / or” includes any and all combinations of one or more of the related listed items.
[0049] As used herein, the term “configuration” refers to the size, shape, material composition, material distribution, orientation, and arrangement of one or more of at least one structure and at least one device in a predetermined manner to facilitate the operation of one or more of the structure and device.
[0050] Figure 1 and Figure 2 An apparatus is shown configured to support a plurality of medical containers or components thereof. This apparatus may generally be referred to in the art as a nest. The medical containers may be vials, syringes (e.g., pre-fillable or pre-loaded syringes), and the like, or the components of the medical containers may be stoppers, syringe pads, and the like. The medical containers are configured, after filling, to contain medical fluids.
[0051] The device includes a plate 100 having an upper surface 102, a lower surface 104, and a sidewall 106 extending between the upper surface 102 and the lower surface 104.
[0052] Sidewall 106 defines the outer perimeter of plate 100. Generally, sidewall 106 includes four edges connected by corners 111, which may be right-angled or rounded. In some embodiments, recesses 107 may be formed in the edges of plate 100. Such recesses 107 are configured to be gripped by a person or machine to facilitate insertion and removal of plate 100 from bucket 130.
[0053] Sidewall 106 is connected to upper surface 102 at upper edge 108 and to lower surface 104 at lower edge 110. Upper edge 108, lower edge 110 and sidewall 106 together define the outer perimeter of plate 100.
[0054] In some embodiments, plate 100 may include a plurality of protrusions 112. Protrusions 112 are those portions of plate 100 that have the largest lateral dimension (e.g., width or length).
[0055] Each of the protrusions 112 defines a portion of the outer periphery of the plate 100. Each protrusion 112 is defined by a portion of the upper surface 102, lower surface 104, sidewall 106, upper edge 108, and lower edge 110 of the plate 100.
[0056] A plurality of protrusions 112 define a small portion of the outer periphery of the plate 100, the remainder of the periphery of the plate 100 being recessed relative to a portion of the sidewall 106 defined by the protrusions 112. When the plate 100 is arranged in the barrel 130, space is provided between the remainder of the sidewall 106 and the inner surface 136 of the barrel 130.
[0057] In other embodiments (not shown), plate 100 may not have protrusions.
[0058] The longitudinal axis of plate 102 extends perpendicular to (e.g., orthogonal to) the upper surface 102. Except for features such as the chimney 105, the upper surface 102 of plate 100 is generally planar. The lower surface 104 may also be generally planar.
[0059] The plate 100 defines a plurality of openings 114 extending from the upper surface 102 through the plate to the lower surface 104. Each opening 114 is configured to hold a medical container or a medical container component therein.
[0060] The plate 100 may also include a plurality of reservoirs 105 projecting axially from the upper surface 102. Each reservoir 105 extends at least partially circumferentially around a corresponding opening 114. Each reservoir 105 may be a generally cylindrical structure. Each reservoir 105 defines an opening in which a medical container may be held. Each reservoir 105 may have a centrally extending longitudinal axis parallel to the longitudinal axis of the plate 102. Each reservoir 105 may be integrally formed with the plate 100.
[0061] Figure 3 A bucket is shown. (Example) Figure 4 As shown, the packaging system 150 includes at least one plate 100 arranged in a barrel 130 for receiving and transporting multiple medical containers or medical container components.
[0062] The barrel 130 includes a plurality of sidewalls 132. The sidewalls 132 extend from a bottom wall defining the bottom of the barrel 130 to a flange 138 defining the top of the barrel 130. The interior of the barrel 130 is hollow and is defined by the inner surface of the bottom wall and the inner surface 136 of the sidewalls 132.
[0063] The barrel 130 is open, allowing the plate 100 to be inserted therein. A flange 138 may be provided at the end of the side wall 132 positioned opposite the bottom wall. After one or more plates 100 having medical containers or medical container components therein are arranged in the barrel 130, a sealing element may be attached to the surface of the flange 138 to close the opening of the barrel 130 and achieve sterilization of the packaging system.
[0064] When the plate 100 is arranged in the barrel 130, at least a portion of the sidewall 106 of the plate 100 contacts the inner surface 136 of the barrel 130. Further, at least a portion of the upper edge 108 and / or the lower edge 110 contacts the inner surface 136 of the sidewall 132 of the barrel 130.
[0065] In embodiments where the plate 100 includes a protrusion 112, the sidewall 106, upper edge 108, and / or lower edge 110 defined by the protrusion contact the inner surface 136 of the barrel 130, while the remainder of the sidewall 106, upper edge 108, and lower edge 110 are separated from (e.g., do not contact) the inner surface 136 of the sidewall of the barrel 130.
[0066] In some embodiments, the sidewall 132 of the barrel 130 is arranged at an obtuse angle relative to the bottom wall, such that the cross-sectional area of the barrel 130 decreases between the top and bottom of the barrel 130. In this case, only a portion of the sidewall 106 and the lower edge 110 of the plate 100 can contact the inner surface 136 of the sidewall of the barrel 130.
[0067] In other embodiments, the sidewalls 132 of the barrel 130 are arranged at approximately right angles to the bottom wall, such that the cross-sectional area defined by the inner surface 136 of the barrel 130 is approximately constant between the top and bottom of the barrel 130. In this case, each of the sidewalls 106, the upper edge 108, and the lower edge 110 of the plate 100 can contact the inner surface 136 of the sidewall of the barrel 130.
[0068] The lower edge 110 and / or upper edge 108 of the plate 100 include curved or rounded surfaces. In some embodiments, portions of the upper edge 108 and / or lower edge 110 defined by each of the plurality of protrusions 112 are curved surfaces. In such embodiments, the remaining portions of the upper edge 108 and / or lower edge 110 defining most of the outer periphery of the plate 100 may be straight edges. In other embodiments, particularly in embodiments where the plate does not include protrusions, the entire upper edge 108 and / or the entire lower edge 110 may be curved surfaces.
[0069] When the plate 100 with curved upper and / or lower edges rubs against the inner surface 136 of the barrel 130 during transport, the presence of the curved surface along the edge of the plate 100 (intended to contact the inner surface of the barrel 130 once placed therein) prevents the generation of material particles from the plate 100 or the barrel 130.
[0070] The radius of curvature of the surface is in the range of 0.03 mm to 1 mm, preferably about 0.3 mm.
[0071] The present invention also relates to a method of forming a plate 100 such that the upper edge 108 and / or the lower edge 110 include surfaces as described above herein.
[0072] Plate 100 can be formed by injection molding. In this method, polymer material of plate 100 is injected into mold 200. Figure 5A-8B The image shows a partial view of a mold 200 that can be used in an injection molding process. The portion of the mold 200 shown is a cross-section of those portions of the mold 200 that have cavities configured to form protrusions 112.
[0073] The mold 200 includes at least one movable portion 202 and a fixed portion 204. The movable portion 202 and the fixed portion 204 together define a mold cavity 210 to form a plate 100. The movable portion 202 and / or the fixed portion 204 have curved surfaces configured to form portions of an upper edge 108 and / or a lower edge 110 defined by each of a plurality of protrusions 112.
[0074] exist Figure 5A and Figure 5B In the illustrated embodiment, both the upper edge 108 and the lower edge 110 have curved surfaces. The fixed portion 204 is shaped to form portions of the upper edge 108, lower edge 110, sidewall 106, and lower surface 104 defined by each of the plurality of protrusions 112. The movable portion 202 is shaped to form portions of the upper surface 106 defined by each of the plurality of protrusions 112. The fixed portion 204 includes curved surfaces configured to form curves at the upper edge 108 and lower edge 110 defined by each of the plurality of protrusions 112.
[0075] The surface 203 of the movable part 202 and the surface 205 of the fixed part 204 are molded together during the injection stage of the process and meet at a location referred to in the art as the parting line.
[0076] exist Figure 5A and Figure 5B In this embodiment, the parting line is located at the same position as the upper surface 106 of the plate 100.
[0077] exist Figure 6A and Figure 6B In the illustrated embodiment, only the lower edge 110 has a curved surface. The fixed portion 204 is shaped to form a portion of the upper surface 102 and upper edge 108 defined by a plurality of protrusions 112, and the at least one movable portion 202 is shaped to form a portion of the lower edge 110, sidewall 106, and lower surface 104 of the plate 100 defined by the plurality of protrusions 112. The at least one movable portion 202 includes a curved surface configured to form a portion of the lower edge 110 defined by the plurality of protrusions 112. In this embodiment, the upper edge 108 defined by the plurality of protrusions 112 includes a straight edge. The parting lines of the fixed portion 204 and the at least one movable portion 202 extend together with the upper surface 102 of the plate 100.
[0078] Conversely, if only the upper edge 108 has a curved surface while the lower edge 110 has a straight edge, then Figure 6A and Figure 6BThe mold shown can be used with a fixed portion 204 and a movable portion 202, wherein the fixed portion is shaped to form a lower surface and a lower edge defined by a plurality of protrusions, and the movable portion includes a curved surface configured to form an upper edge defined by a plurality of protrusions 112.
[0079] exist Figure 7A and Figure 7B In the illustrated embodiment, the fixed portion 204 is shaped to form a portion of an upper surface 102, an upper edge 108, and a sidewall 106 defined by each of the plurality of protrusions 112, and the at least one movable portion 202 is shaped to form a portion of a sidewall 106, a lower edge 110, and a portion of a lower surface 104 defined by each of the plurality of protrusions 112. Each of the fixed portion 204 and the at least one movable portion 202 includes a curved surface to form the curved surfaces of the upper edge 108 and the lower edge 110 defined by each of the plurality of protrusions 112. The parting line 203 of the fixed portion 204 and the at least one movable portion 202 is positioned along the sidewall 106 of the plate 100 between the upper surface 102 and the lower surface 104.
[0080] exist Figure 8A and Figure 8B In the illustrated embodiment, the movable portion 202 includes two distinct molded parts: a movable portion 202 including a cavity and a slider 206 including a cavity. The slider 206 is shaped to form a portion defined by an upper edge 108, a sidewall 106, and a lower edge 110 of each of a plurality of protrusions 112. The slider 206 includes curved surfaces to form the curved surfaces of the upper edge 108 and the lower edge 110 defined by each of the plurality of protrusions 112. A parting line (205) between the slider 206 and the movable portion 202 is positioned along the upper surface 102 of the plate 100, and a parting line (203) between the slider 206 and the fixed portion 204 is positioned along the lower surface 104 of the plate 100.
[0081] In injection molding, flash occurs when molten plastic flows out of mold 200 along the parting line and solidifies. If this flash is generated along the surface of protrusion 112 that contacts the inner surface of barrel 130, particles may be generated on barrel 130 or plate 100 due to friction between the flash and the inner surface of barrel 130. This method may include removing such flash by mechanical means (e.g., by cutting, breaking, grinding, or tumbling) or by chemical means (e.g., etching) before arranging the medical container in the opening 114 of plate 100 and / or before arranging plate 100 in barrel 130. Positioning the parting line along the upper surface 102 and / or lower surface 104 of protrusion 112 (these surfaces do not substantially contact the inner surface of the sidewall 132 of barrel) as described herein reduces the likelihood of any unintentionally remaining flash material generating particles after flash removal.
[0082] While this disclosure has been described with reference to certain illustrated embodiments, those skilled in the art will recognize and understand that this disclosure is not limited thereto. Rather, many additions, deletions, and modifications, including their legal equivalents, can be made to the illustrated embodiments without departing from the scope of this disclosure. Furthermore, features of one embodiment may be combined with features of another embodiment, but still fall within the scope of the invention as contemplated by the inventors.
Claims
1. An apparatus for receiving a medical container or a component of a medical container, comprising: A plate (100) having an upper surface (102), a lower surface (104), and a sidewall (106) extending between the upper surface (102) and the lower surface (104), the plate (100) defining a plurality of openings (114) extending from the upper surface (102) through the plate to the lower surface (104), each opening (114) being configured to hold a medical container or a medical container component therein. The sidewall (106) is connected to the upper surface (102) at its upper edge (108) and to the lower surface (104) at its lower edge (110), the upper edge (108), the lower edge (110), and the sidewall (106) defining the outer periphery of the plate (100). Wherein, at least a portion of the upper edge (108) and at least a portion of the lower edge (110) are curved surfaces, and The radius of curvature of the surface is in the range of 0.03 mm to 1 mm.
2. The apparatus according to claim 1, wherein, The radius of curvature of the surface is approximately 0.3 mm.
3. The apparatus according to any one of claims 1-2, wherein, The plate (100) includes a plurality of protrusions (112), each of which defines a portion of the upper surface (102), the lower surface (104), the sidewall (106), the upper edge (108), and the lower edge (110) of the plate (100), and a small portion of the outer periphery of the plate (100) is defined by the plurality of protrusions (112).
4. The apparatus according to claim 3, wherein, The upper edge (108) and lower edge (110) of the outer periphery of the plate (100) are straight edges.
5. A packaging system (150), comprising: The apparatus according to any one of claims 1-4; and A bucket (130) having a plurality of sidewalls (132) having an inner surface (136) defining a space configured to receive the plate (100) therein. When the device is arranged in the barrel (130), the curved surfaces of the upper edge (108) and / or the lower edge (110) contact the inner surface (136) of the barrel.
6. A method of forming an apparatus according to any one of claims 1-4, comprising: The polymer material of the plate (100) is injected into a mold (200), the mold including a fixed portion (204) and at least one movable portion (202, 206), wherein the at least one movable portion (202, 206) and the fixed portion (304) together define a mold cavity (210) to form the plate (100), wherein the at least one movable portion (202, 206) and the fixed portion (204) have curved surfaces, the curved surfaces of the at least one movable portion and the fixed portion being configured to form the curved surfaces of the upper edge (108) and the lower edge (110) defined by each of the plurality of protrusions (112).
7. The method according to claim 6, wherein: The fixing portion (204) is shaped to form a portion of the upper edge (108), the lower edge (110), and the sidewall (106) defined by each of the plurality of protrusions (112). The at least one movable portion (202) is shaped to form a portion of the upper surface (106) defined by each of the plurality of protrusions of the plate (100), and The fixing portion (204) includes a curved surface, which is configured to form a curved surface at the upper edge (108) and the lower edge (110) defined by each of the plurality of protrusions (112).
8. The method according to claim 7, wherein, The parting line (205) of the fixed part (204) and the movable part (202) extends together with the upper surface (102) of the plate (100).
9. The method according to claim 6, wherein: The fixing portion (204) is shaped to form a portion of the upper surface (102), the upper edge (108), and the sidewall (106) defined by each of the plurality of protrusions (112). The at least one movable portion (202) is shaped to form a portion of the sidewall (106) defined by each of the plurality of protrusions (112), a portion of the lower edge (110) and the lower surface (104), and Each of the fixed portion (204) and the at least one movable portion (202) includes a curved surface to form the curved surface of the upper edge (108) and the lower edge (110) defined by each of the plurality of protrusions (112).
10. The method according to claim 9, wherein, The parting lines (203, 205) of the fixed part (204) and the at least one movable part (202) are positioned along the sidewall (106) between the upper surface (102) and the lower surface (104) of the plate (100).
11. The method according to claim 6, wherein: The at least one movable part (202) includes a slider (206) and the movable part (202). The slider (206) is shaped to form portions of the upper edge (108), the sidewall (106), and the lower edge (110) defined by each of the plurality of protrusions (112), and The slider (206) includes a curved surface to form the curved surface of the upper edge (108) and the lower edge (110) defined by each of the plurality of protrusions (112).
12. The method according to claim 11, wherein, The parting line (205) of the slider (206) and the movable part (202) is positioned along the upper surface (102) of the plate (100), and wherein the parting line (203) of the slider (206) and the fixed part (204) is positioned along the lower surface (104) of the plate (100).