Finger grip

By designing the linear or point contact between the finger grip component of the syringe and the syringe, the problem of poor sterilization effect of existing syringes is solved, and the mechanical stability and gas pathway improvement is achieved, which is suitable for sterilization of sensitive drugs.

CN119604320APending Publication Date: 2025-03-11TERUMO EURO
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Patent Information

Application Number
CN202380056567.8
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-07-07
Filing Date
2023-07-07
Publication Date
2025-03-11

AI Technical Summary

Technical Problem

Existing syringes are difficult to effectively eliminate bacteria from assembled parts and outer surfaces during sterilization, especially for sensitive drugs, radiation or high temperature sterilization may not be suitable, and fluid sterilizers are difficult to achieve the desired sterilization level.

Method used

By designing the base and collar portion of the finger grip component, it forms linear or point contact with the flange and cylinder of the syringe, reducing the area of ​​the occluded outer surface, improving gas passages, and reducing the chance of contaminant adhesion through the smooth inner surface.

Benefits of technology

Mechanical stability is achieved between the syringe and the finger grip component, while improving the gas passage, ensuring effective sterilization effect, suitable for sensitive drugs, and compatible with conventional manufacturing methods.

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Abstract

There is provided an injection device (1) comprising: a syringe (10) having a barrel portion (11) and a flange (12); and a finger grip (100) coupled to the syringe. The finger grip includes a base (104) that receives the flange and a collar (103) that receives an end portion of the barrel adjacent the flange. An inner surface (110, 120) of the base portion and an inner surface (130) of the collar provide a first set of first point and / or line contacts (C1) for engagement with an outer surface of the flange and a second set of second point and / or line contacts (C2) for engagement with an outer surface of the barrel portion, respectively. The inner surface is smooth or free of outwardly extending protrusions for contact with a syringe. Contact with respect to the flange and / or the barrel may be loose.
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Description

Technical Field

[0001] Aspects of the present disclosure relate to an injection device for drug delivery. Specifically, the present disclosure generally relates to a finger grip attachment for association with an injection device, an assembly of an injection device and a finger grip attachment associated therewith, a sterilized injection device prefilled with a drug package, and a method of manufacturing. Background Art

[0002] A syringe is a medical delivery device used to administer medication to a patient.

[0003] Syringes are typically sold in pre-filled form, wherein a set dose of the drug is already provided in the syringe, or the syringe is empty and is intended to be filled by the end user from a vial or other source of drug when administration of the drug is desired.

[0004] The syringe generally includes a barrel portion for holding the drug. The distal end of the barrel is generally configured for connecting the barrel to the cannula, typically by a hub. When the hub is connected to the syringe, a fluid connection is established between the needle and the syringe so that the fluid from the syringe can be injected through the needle.

[0005] The piston rod can be inserted through the open proximal end of the syringe barrel. The user can apply the drug by applying manual force to the piston.

[0006] Commercial syringes are often provided with a flange. The flange is often provided around the open proximal end of the syringe barrel and extends radially from the open proximal end to provide a form of finger rest for manipulating the device.

[0007] In order to improve the grip, usability and / or ergonomics of the syringe, it is known to couple a finger grip to the device. The finger grip is sometimes also referred to as a "stop". The radial length of the finger grip may be greater than the length of the flange of the barrel. Alternatively or additionally, the finger grip may provide a more ergonomic surface to the user, for example to reduce user fatigue. In order to provide a stable connection to the device, the finger grip is typically configured to engage with one or more of the flange or a portion of the barrel.

[0008] The finger grip may be provided in a variety of configurations. Known variations include components configured to couple with the device in an axial direction of the barrel, such as by sliding along the barrel from the proximal end of the barrel toward a flange. Components that couple to the device in a radial direction, such as by sliding along a radially extending flange and / or snapping onto the barrel, are also known. Alternative variations include a multi-component grip that can be assembled (e.g., fitted) around a syringe.

[0009] For the integrity of the drug and patient safety, it is important to fully sterilize the syringe. Sterilization can be performed in multiple stages. For example, it can be performed during the assembly process, which includes a pre-filling stage (e.g., sterilization of the empty barrel and / or piston) and a post-filling stage (e.g., external sterilization of the assembled pre-filled syringe).

[0010] External sterilization typically occurs after the syringe has been fully assembled and optionally pre-filled and / or at least partially positioned in the syringe's final packaging.

[0011] External sterilization may present many challenges / limitations. For example, in some cases (e.g., for sensitive drugs), sterilization by radiation or temperature may be inappropriate. Sterilization by fluid sterilants (usually gases such as steam, NOx or ethylene oxide) may make it difficult to achieve the desired or required sterilization level of the outer surfaces of the assembled components and / or syringes. In particular, effective sterilization of the surfaces between the syringe and the components connected to the syringe (e.g., the finger grip) remains a challenge.

[0012] US20210060258A1 discloses an injection device as follows, the injection device includes a syringe and a stopper, the syringe having a barrel and a flange, the stopper being configured to be connected to the syringe and adjacent to the flange. The stopper includes an inner surface extending substantially around at least a portion of the syringe, wherein the inner surface includes at least one protrusion, at least one protrusion extending away from the inner surface and configured to engage the flange and / or barrel to allow or promote air flow through the space between the inner surface and the syringe. The protrusion can help to locally reduce the occluded surface area between the stopper and the barrel and / or flange. Summary of the invention

[0013] The present disclosure aims to provide a solution having a further improved gas path between the syringe and the finger grip attachment when they are associated, while providing at least acceptable or even improved mechanical stability during normal use. As described in detail below in this document, the present disclosure provides an injection device having a reduced or even eliminated occluded outer surface area. The device also provides: compatibility with conventional mechanized assembly lines and / or relaxed (large-scale) manufacturability of the grip component, in particular compatibility with molding methods.

[0014] Aspects of the present disclosure relate to a finger grip attachment for use in association with an injection device and to an assembly of a syringe and a finger grip attachment. In addition, the present disclosure provides a packaged injection product, in particular an assembly of a finger grip attachment and a syringe device. The syringe may be pre-filled with a drug and / or exposed to a gaseous sterilant (even when pre-filled or partially packaged). The present disclosure also provides a method of making a grip portion and a method of making a packaged injection product.

[0015] Accordingly, according to a first aspect, there is provided an injection device comprising: a syringe having a barrel and a flange; and a finger grip coupled to the syringe. The syringe may be pre-filled with a drug. Alternatively, the syringe may be empty.

[0016] The finger grip comprises at least a base portion defining a first portion of a cavity of the grip, the first portion receiving the flange, and a collar portion defining a second portion of the cavity of the grip, the second portion receiving an end portion of the barrel adjacent to the flange. To improve the ergonomics, tactile feel and / or operability of the device, the grip may be provided with a first finger rest portion and a second finger rest portion extending laterally from the grip (e.g. from one side of the base and / or collar).

[0017] In order to provide a mechanically reliable connection between the finger grip and the syringe, the inner surface of the base portion and the inner surface of the collar are formed so as to provide a first group of first contacts and a second group of second contacts, respectively, the inner surface of the base portion defining the first portion of the chamber, the inner surface of the collar defining the second portion of the chamber, the first group of first contacts being used to engage with the outer surface of the flange, and the second group of second contacts being used to engage with the outer surface of the barrel. It should be understood that the contacts included in the first and second groups are distributed around the receiving portions for receiving the flange and the barrel respectively. For example, in order to provide a stable connection with the flange, the first group of contacts includes contacts arranged to engage with the bottom and top surfaces of the engaged flange. The contacts are generally distributed to exclude flush contact areas during full connection. In order to reduce, for example, the accidental release of the grip during operation, the barrel receiving portion can be configured to provide a snap-fit ​​relationship.

[0018] In order to minimize the total contact area between the grip and the syringe, the contact can be configured as a so-called line contact, point contact or a combination thereof. The grip is configured so that the connection with the syringe is achieved by point contact and / or line contact, which advantageously minimizes the total contact area (in particular the flush contact area) between the grip and the syringe. Therefore, even in the connected state, the grip as a finger grip and the outer surface of the syringe can advantageously maintain an air passage that can be used to achieve through the channel / space formed between the contact parts, for example for sterilization with a gaseous agent (such as NOx, ethylene oxide or any other suitable agent known in the art). In some variations, the first contact part and the second contact part are all composed of line contacts. The orientation of the line contact part is preferably such that: at the collar, the contact part is aligned (parallel) with the axial direction of the barrel, and at the base, the line is aligned with the lateral connection direction / sliding movement of the grip to the syringe.

[0019] In a particularly preferred variant, the inner surface of the base portion of the grip surrounding the chamber (in particular, at least the corresponding inner surface of the base portion of the grip) and the inner surface of the base portion of the grip are smooth or at least free of outwardly extending protrusions for contacting portions of the syringe in the following area, which area is included at least in the contact portion included in the first group and the second group. Reducing the number of outwardly extending protrusions and / or providing a smooth surface finish advantageously reduces the number of corners, ridges, irregularities and / or shielding surface portions (for example at edges or steep angles at the base of the outwardly extending protrusions) for contaminants to adhere. In addition, minimizing roughness and / or eliminating the presence of protrusions relaxes one or more stages of manufacturing the grip (including filling and releasing from the mold).

[0020] Advantageously, the grip may be manufactured as a single integral piece rather than an assembly of two or more assembled (e.g. glued) sub-components. It will be appreciated that the term smooth includes surfaces having gradually inclined surfaces, bends, folds and / or intersections of two or more inclined surfaces (e.g. the intersection of adjacent flat surfaces).

[0021] To increase maneuverability, the grip may include one or more finger rest portions. As is known in the art, these portions increase the accessible surface area for manual handling of the device. To this end, the grip may provide at least a first finger rest portion and a second finger rest portion. The finger rest portions may, for example, extend laterally from the grip, such as from a collar or base portion.

[0022] Advantageously, the engagement between the grip and the syringe may be provided only by the contacts included in the first and second sets of contacts or a subgroup thereof. In this way, it may be achieved that during normal use, the opposing faces of the grip and the syringe (excluding line or point contacts) are separated by a gap.

[0023] In some variations, the grip may be constructed, shaped, or dimensioned so that most or even all of the contacts actually engage the syringe. However, it should be understood that when coupled, not all contacts need to participate in engaging the syringe at the same time.

[0024] In some variations, when fully coupled, some of the contacts and the syringe maintain a spacing distance between them, for example, between the flange and the vertex of the contact at a portion of the base portion that faces the top surface of the flange.

[0025] Specifically, in one variation, there is a tight coupling between the flange of the syringe and the base portion of the grip, and a looser coupling between the collar of the grip and the barrel of the syringe. In another variation, the grip is configured such that there is a tight coupling between the barrel of the syringe and the collar portion of the grip, and a looser coupling between the flange of the syringe and the base portion of the grip. The inventors have found that for both configurations, during normal operation, mechanical stability can be excellent, and play between corresponding components can be substantially insignificant or at least acceptable.

[0026] Correspondingly, in a preferred variant, there is a tight connection between the flange and the grip of the syringe through a base portion, which is configured to provide simultaneous direct contact of each of the first contact portions included in the first subset with the outer surface of the flange, and wherein there is a looser connection between the barrel and the grip of the syringe through a collar portion, which is configured to enable only a limited subset of the second contact portions included in the second group to be in simultaneous direct contact with the barrel during normal operation.

[0027] In another preferred variant, wherein, by means of a collar portion, there is a tight connection between the barrel and the grip of the syringe, the collar portion being configured to provide simultaneous direct contact of each of the second contact portions included in the second subset with the outer surface of the barrel, and wherein, by means of a base portion, there is a looser connection between the flange and the grip of the syringe, the base portion being configured to enable only a limited subset of the first contact portions included in the first group to be in simultaneous direct contact with the flange during normal operation.

[0028] The maximum play (distance) between the non-engaging first contact portion and the flange or between the non-engaging second contact portion and the barrel portion affects the gas flow resistance between the components, for example during sterilization. The larger the play, the lower the flow resistance can be. In order to minimize the potential impact on the mechanical stability of the connection, the play preferably does not exceed about 0.8 mm. Preferably, it is below 0.4 mm, most preferably in the range of 50 μm to 300 μm.

[0029] In yet another variation, the connection to both the flange and the barrel is loose. In this variation, the grip is configured so that during normal operation, only a limited subset of the first and second contact portions included in the first and second groups can be in direct contact with the flange (respectively, with the barrel) at the same time. The inventors have found that a somewhat loose (not tight) configuration of the connection to both the barrel and the flange can further increase the gas passage between the syringe and the flange while still providing acceptable mechanical stability, in particular, as long as the play does not exceed 0.8 mm, preferably ≤0.4 mm, most preferably ≤0.3 mm.

[0030] The total number of first contacts for engaging the flange is preferably as low as possible. Advantageously, this number can be as low as four. Typically, the set of first contacts includes two (or more) contacts for engaging with the top surface of the flange and two (or more) contacts for engaging with the bottom surface of the flange.

[0031] The total number of second contacts for engaging the barrel is preferably as low as possible. Typically, the number of line contacts included in the second group is ≤10. Preferably, ≤7. Advantageously, the number of second contacts for engaging the barrel can be as low as 5 or even 3 without compromising the mechanical stability of the coupling.

[0032] In some variations, the grip further includes a stop (eg, a lug) to limit release of the piston from the barrel.

[0033] The present disclosure also provides a finger grip, the finger grip being configured for coupling with a syringe, the syringe comprising a barrel and a flange, preferably the finger grip is a finger grip as defined herein. The finger grip comprises at least: a base portion of the grip, the base portion of the grip defining a first portion of a cavity of the grip, the first portion being for receiving the flange; a collar portion of the grip, the collar portion of the grip defining a second portion of a cavity of the grip, the second portion being for receiving an end portion of the barrel adjacent the flange; and preferably at least a first finger rest and a second finger rest, the first finger rest and the second finger rest extending laterally from the grip, wherein an inner surface of the base portion and an inner surface of the collar are formed so as to provide a first set of first contacts and a second set of second contacts, respectively, the inner surface of the base portion defining the first portion of the cavity and the inner surface of the collar defining the second portion of the cavity, the first set of first contacts being for engaging with an outer surface of the flange and the second set of second contacts being for engaging with an outer surface of the barrel, and wherein the inner surface of the base portion of the grip and the inner surface of the base portion of the grip are smooth or at least free of outwardly extending protrusions for contacting portions of the syringe in an area at least including the contacts included in the first set of contacts and the second set of contacts. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] These and other features, aspects, and advantages of the apparatus, systems, and methods of the present disclosure will be better understood through the following description, appended claims, and accompanying drawings, in which:

[0035] Figure 1 A side view of an injection device for drug delivery is provided;

[0036] Figure 2 A cross-sectional view of an injection device is provided;

[0037] Figure 3 A top view of the finger grip is provided;

[0038] Figure 4 A cross-sectional top view of the injection portion is provided;

[0039] Figure 5 A partial cross-sectional side view of an injection device is provided;

[0040] Figure 6 A side view of the finger grip is provided;

[0041] Figure 7 A perspective top view of the finger grip is provided;

[0042] Figure 8 A perspective bottom view of the finger is provided;

[0043] Fig. 9A partial side view of an injection device for drug delivery is provided;

[0044] Fig.10 A partial cross-sectional side view of an injection device is provided;

[0045] Fig.11A and Fig. 11B A cross-sectional bottom view of the injection device is provided;

[0046] Fig. 12A and Fig. 12B A cross-sectional bottom view of the injection device is provided;

[0047] Fig.13 A partial side view of an injection device is provided;

[0048] Fig.14 and Fig.15 Provided Fig.13 a detailed view of the device shown;

[0049] Fig.16 A cross-sectional bottom view of the injection device is provided;

[0050] Fig.17 A bottom view of the finger grip is provided;

[0051] Fig.18 A partial bottom view of the finger grip is provided;

[0052] Fig.19 A local side of the injection device is provided;

[0053] Fig. 20 A partial side providing a finger grip; and

[0054] Fig.21A , Fig. 21B and Fig. 21C A side view of an injection device is provided. DETAILED DESCRIPTION

[0055] The terms used to describe specific embodiments are not intended to limit the present invention. Unless the context clearly indicates otherwise, as used herein, the singular forms "one", "an" and "the" are intended to also include plural forms. The term "and / or" includes any one of the listed related items and all combinations of one or more. It should be understood that the terms "include" and / or "comprise" indicate the presence of the stated features, but do not exclude the presence or increase of one or more other features. It should also be understood that when a specific step of a method is described as being after another step, unless otherwise stated, the specific step may directly follow the other steps, or one or more intermediate steps may be performed before performing the specific step. Similarly, it should be understood that when describing a connection between a structure or component, unless otherwise stated, the connection may be established directly or through an intermediate structure or intermediate component.

[0056] The present invention is described more fully below with reference to the accompanying drawings, in which embodiments of the invention are shown. In the accompanying drawings, the absolute and relative sizes of systems, components, layers, and regions may be exaggerated for clarity. The embodiments will be described with reference to schematic and / or cross-sectional views of possible ideal embodiments and intermediate structures of the present invention. In the specification and the drawings, similar reference numerals always represent similar elements. Related terms and derivatives of related terms should be understood to mean the meaning as described at the time or shown in the drawings discussed. Unless otherwise stated, these related terms are for convenience of description and the system does not need to be constructed or operated in a specific direction.

[0057] Figure 1 A side view of an injection device 1 for drug delivery according to the present disclosure is provided. The device includes a syringe 10 having a barrel 11 and a flange 12. The flange 12 is arranged along the proximal end 11p of the barrel. The opposite distal end 11d is shown as including a hub 13 for receiving a cannula (not shown). The device 1 also includes a finger grip 100. The grip is depicted as being in a fully engaged position. The grip engages the flange from the upper surface 12-1 and the lower surface 12-2 of the flange. The grip also engages a portion of the outer surface of the barrel at the proximal end. The finger grip 100 is mounted around a piston 14 inserted into the barrel. During normal operation, the grip does not contact the piston. The piston can slide within the barrel along its central longitudinal axis A. Advantageously, and as in Fig.17 As best seen in FIG, the grip may act as a stop, for example, by way of a tab 50. The stop enables passage of the piston rod 14r, but limits movement of the piston when engaged with the piston base 14b.

[0058] The radially extending wings 101, 102 of the finger grip provide an extended surface area for the user to hold the device. As described in detail below, the grip can be configured in a variety of variations, including a variation that is tightly connected to both the barrel and the flange, a variation that is tightly coupled to the flange and loosely coupled to the barrel, a variation that is tightly coupled to the barrel and loosely coupled to the flange, and a variation that is slightly loosely coupled to both the flange and the barrel.

[0059] Figure 2 to Figure 2 1 provides detailed views of aspects relating to an embodiment of an injection device 1, a finger grip 10 and a coupling between the grip and the syringe, wherein FIGS. 11 to 12 are Fig.15 Aspects of embodiments configured to achieve a tight coupling between a grip portion on the one hand and a barrel portion and flange on the other hand are described in detail, and wherein Figure 16 to Figure 2 1 shows aspects of a variant with one looser coupling to the syringe (flange or barrel). It should be understood that variants with looser coupling to both the barrel and the flange include corresponding aspects where appropriate.

[0060] For example, Figure 5 , Figure 8 and Fig.10 As best seen in FIG. 1 , the grip 100 may be understood, at least conceptually, as comprising two interconnected portions including a base portion 104 providing a berth for receiving the flange 12 and a collar portion 103 providing a berth for receiving the barrel 11. The berths are fluidly connected to form a continuous chamber.

[0061] Figure 5 A detailed side view of the device is provided focused around the finger grip 100 associated with the flange 12 and the proximal end 12p of the barrel 12 in a fully engaged position. Figure 2 A cross-sectional bottom view of the injection device just below the collar is provided, wherein the piston has been omitted so as not to obstruct detailed viewing. Figure 4 A corresponding top view is provided. Figure 3 A top view of the finger grip in empty form (without a syringe inserted) is provided. Figure 6 Provided Figure 5 A view of the construction shown in but without the syringe. Figure 7 and Figure 8 A top view and a perspective bottom view of the empty grip are provided. Fig. 9 and Fig.10 Provided separately Figure 5 Side view and cross-sectional side view of the construction shown.

[0062] like Figure 6As shown, the grip 100 includes a chamber 150 for receiving a syringe. The chamber can be understood to include a first portion 151 (receiving portion) and a second chamber portion 152 (receiving portion), the first portion being used to receive the flange 12 of the syringe, and the second chamber portion being fluidly connected to the first portion and being used to receive the barrel 11 along the terminal end 11p of the barrel. As shown, the first portion 151 of the chamber can be understood to be defined between the opposing inner surfaces 110, 120 of the base portion 104 of the finger grip 100. The second portion 152 of the chamber for receiving the barrel of the syringe is laterally bounded by the inner surface 130 of the collar portion 103, the inner surface of the collar portion extending downwardly from the wall portion defining the first chamber portion in a direction along the central axis "A". The collar typically extends over a length of at least 2 mm, the length typically being in the range of 2 to 10 mm, such as in the range of 3 mm to 6 mm, such as about 5 mm. The longer the collar portion, the more stable the connection with the syringe will be. To minimise the effect on gas flow resistance between the collar and the barrel, the overlap is preferably ≤ 10 mm.

[0063] It will be appreciated that the grip advantageously provides an open structure to maximize the gas passage to the syringe. To this end, the wall defining the chamber may be provided with one or more holes. Figures 6 to 10 As best seen in , chamber 151 can be understood to be defined laterally by opposing sidewalls 105, 106. These side faces are generally not engaged with the flange or any other part of the syringe to minimize the flush contact area. At least one of the sidewalls 105 includes a first hole a1, the size of which is designed to receive the flange from a lateral direction. The opposing sidewall 106 may be provided with a second hole a2, which is generally relatively smaller than the first hole, so that gas can pass through the chamber. The wall defining the top of chamber 151 includes an additional hole a4, the shape of which is designed to accommodate the passage of the piston rod. The shape / size of the collar is generally designed to partially surround the outer periphery of the barrel, wherein the size of the hole a3 is designed to enable the barrel to be inserted from a lateral direction.

[0064] Similar to the wall defining the first portion 151 of the chamber, the collar may include one or more additional openings to further improve the passage of gas through the chamber. Figure 7 , Figure 8 and Fig.10 Shown in. Figure 3 and Figure 7 Also shown are residual marks m formed by injection molding.

[0065] The grip portion includes a plurality of contacts C1-1, C1-2, C1-3, C1-4, C2-1, C2-2, C2-3, C2-4, C2-5 for engaging with opposite points along the outer surface of the syringe. In each of the embodiments presented below in this document, the first set of contacts C1 (for engaging with the flange) and the second set of contacts C2 (for engaging with the barrel) are implemented in the form of contact lines. It should be noted that, as shown, the inner surfaces 110, 120 and 130 are substantially free of protrusions.

[0066] The contact wire can be provided in various ways. In a variant, for example Fig.11A , Fig. 11B , Fig. 12A , Fig. 12B , Fig.13 , Fig.14 , Fig.15 as well as Fig.16 As best seen in , the contact portion can be formed by one or more of the following: a tangential contact portion between the outer surface of the flange or barrel of the syringe and one face of the multi-faceted portion of the inner surface of the collar portion or base portion (for example, at a central portion thereof); a contact portion between the outer surface of the flange or barrel of the syringe and one of the vertices of the curved portion (or bend) of the inner surface of the collar portion or base portion; and / or an intersection or bend between two faces of the multi-faceted portion of the inner surface of the collar portion or base portion that is bent or curved.

[0067] like Figures 13 to 15 As shown, the linear contact can be achieved by a portion of the inner surface oriented at an angle α (α1, α2, α3) relative to the upper and lower surfaces of the flange to be received. The angle is generally in the range of between 1° and a maximum of 45°. Preferably, the angle is in the range of about 5 degrees to about 20 degrees. When the syringe is connected to the grip, a substantially linear contact portion is formed. An angle within the specified range is found to provide sufficient gas passage. In some embodiments, for example Figure 14 to Figure 15 As shown, the inner surface may be comprised of two or more inclined regions that meet at an intersection providing a linear vertex. Note that the slopes in schematics "i" and "ii" may be exaggerated for clarity.

[0068] The contact between the inner surface 130 of the collar 103 and the barrel 11 of the syringe is achieved without the presence of protrusions.Protrusion-free contact can be achieved in a variety of ways.

[0069] For example, linear contact may be provided by a receiving portion (chamber portion 152) for the barrel having a polygonal cross section. Instead of providing a protrusion, the inner surface of the collar 103 may be configured to include a plurality of faces arranged at an angle relative to each other. Upon insertion of the barrel, some or each of the flat faces may form tangential contact with the barrel. The number of planes is ≥ 3. In one embodiment, for example, Fig.11A and Fig.17 B, the collar includes five flat surfaces 130-1, 130-2, 130-3, 130-4, 130-5 (see Fig.17 ), the 5 flat faces are oriented to provide an object somewhat similar to a hexagonal barrel receiving portion open along one side. Because the barrel has a circular shape, the overall flush contact area can be ignored.

[0070] In another variation or additional variation, the barrel receiving portion may be oblong. Fig. 12B As best seen in FIG. 1 , the inner surface 130 of the collar can be substantially smooth. When coupled to the syringe, the inner surface of the collar 103 forms three tangential contacts c2-1, c2-2, c2-3 with the barrel 11. The total contact area between the barrel and the collar can be neglected. Note the gas passage P between the barrel and the collar.

[0071] It should be understood that the barrel receiving portion should not be construed as limited to the depicted configuration, and other polygonal or smoothly curved cross-sections are contemplated (eg, square, octagonal, elliptical, etc.).

[0072] Fig.16 A variation is described in detail in which the grip is configured to provide a loose contact with the barrel. Specifically, the collar is slightly oversized relative to the cross-sectional dimensions of the barrel to be received. In particular, the flat contact surfaces 130-1 to 130-5 are positioned so that a maximum of three simultaneous contacts can be formed between the collar and the barrel. Fig.16 In FIG. 1 , the barrel is shown in an extreme position where two simultaneous contact lines c2-1 , c2-2 are achieved. There is some space or slack "s" along the opposite ends.

[0073] Fig.18 Another variation is described below in which the grip is configured to provide a loose contact with the barrel. FIG. 12A to FIG. 12B Compared to the variant shown in , the receiving portion is oblong, so that only two simultaneous contacts with the barrel 11 can be achieved when fully coupled.

[0074] A slightly loose fit improves the gas path between the barrel and the finger grip. Typically, the play is ≥ 1 μm, such as ≥ 5 μm. Typically, the play is ≤ 300 μm, such as ≤ 200 μm, such as between 5 μm and 300 μm or between 1 μm and 200 μm. The inventors have found that within the specified range, the play is substantially unnoticeable to the end user during normal handling operation.

[0075] Of course, the gripping portion may be configured so that the receiving portion matches the outer diameter of the barrel to be received (see FIGS. 11, 12 and 13 ). Fig.17 ), thereby producing a total of five contacts with the barrel 11 (correspondingly, three line contacts).

[0076] Fig.19 , Fig. 20 and 21 detail aspects of a configuration in which the grip is sized to provide a looser coupling to the flange. Fig.19 and FIG. 21A to FIG. 21C A partial side view of an injection device 1 for administering a drug is provided. Fig. 20 The same grip is shown, but without the syringe.

[0077] As can be seen, the chamber portion 151 for receiving the flange defined between the inner surfaces 110 and 120 is oversized relative to the thickness of the flange 12 to be received. In the illustrated embodiment, the syringe is shown with the lower surface 12-2 of the flange 12 engaged with the inner surface 120. Therefore, there may be a space or clearance S between the upper surface 12-1 and the surface 110. The clearance improves the gas passage between the flange and the finger grip. Typically, the clearance is ≥1μm, such as ≥5μm. Typically, the clearance is ≤400μm, ≤300μm, such as ≤200μm, such as between 5μm and 300μm or between 1μm and 200μm. The inventors have found that within the specified range, the end user will not substantially notice it during normal gripping operation.

[0078] The oversizing of the barrel receiving portion and / or the flange receiving portion is advantageously adapted to conventional syringe manufacturing tolerances. The grip portion can advantageously be manufactured using conventional manufacturing methods including, but not limited to, molding (e.g., injection molding), or even manufactured as a single component. Without wishing to be bound by theory, it is believed that simplified manufacturing is at least partially related to providing a smooth inner surface of the grip portion as disclosed herein. Specifically, it is believed that the absence of outwardly extending protrusions (ribs, stakes, domes) facilitates filling of the mold and release of the formed product from the mold.

[0079] The method includes: using a mold to form a plastic composite, typically a thermoplastic composite, the mold being configured to define: a base portion of a grip portion, the base portion of the grip portion defining a first portion of a cavity of the grip portion, the first portion of the cavity of the grip portion being configured to receive the flange; a collar portion of the grip portion, the collar portion of the grip portion defining a second portion of the cavity of the grip portion, the second portion of the cavity of the grip portion being configured to receive an end portion of the barrel portion adjacent the flange; and at least a first finger rest and a second finger rest extending laterally from the grip portion, wherein the mold is configured so that the base portion The inner surface of the base portion and the inner surface of the collar are formed so as to provide a first set of first contact portions and a second set of second contact portions, respectively, the inner surface of the base portion defines a first portion of the chamber, the inner surface of the collar defines a second portion of the chamber, the first set of first contact portions are used to engage with the outer surface of the flange, and the second set of second contact portions are used to engage with the outer surface of the barrel, and wherein the mold is configured so that the inner surface of the base portion of the grip and the inner surface of the collar portion of the grip are smooth or at least have no outwardly extending protrusions for contacting parts of the syringe.

[0080] Advantageously, the disclosed injection device may be pre-filled with a medication, such as an ophthalmic medication.

[0081] The drug may advantageously be packaged wherein the exterior of the injection device is sterilized, whereby the syringe may be empty or pre-filled.

[0082] A packaged injection device may be provided by a method comprising: a) providing a syringe comprising a barrel and a flange; b) filling the syringe with a drug if desired; c) providing a finger grip, the finger grip comprising: a base portion defining a first portion of a cavity of the grip, the first portion being adapted to receive the flange; a collar portion defining a second portion of the cavity of the grip, the second portion being adapted to receive an end portion of the barrel adjacent the flange; and at least a first finger rest portion and a second finger rest portion, the first finger rest portion and the second finger rest portion extending laterally from the grip, wherein an inner surface of the base portion and an inner surface of the collar are formed so as to provide a first set of first contacts and a second set of second contacts, respectively. The invention relates to a method of manufacturing a syringe having a first syringe and a second syringe having a plurality of first and second contact portions, wherein the inner surface of the base portion defines a first portion of the chamber, the inner surface of the collar defines a second portion of the chamber, a first set of first contacts for engaging with an outer surface of the flange, a second set of second contacts for engaging with an outer surface of the barrel, and wherein the inner surface of the base portion of the grip and the inner surface of the base portion of the grip are smooth or at least lack outwardly extending protrusions for contacting a portion of the syringe; d) coupling the finger grip to the syringe to form an injection device comprising at least the syringe and the finger grip coupled to the syringe; e) sterilizing the exterior of the injection device by a process comprising exposure to a gaseous sterilant; f) arranging the injection device in a package; and g) sealing the package. Advantageously, sterilization can be performed after filling and / or after coupling. Optionally, sterilization or further sterilization can include exposure to a gaseous sterilant. Furthermore, optionally, sterilization can be performed with the product already partially or completely arranged in the package.

[0083] For the purpose of clear and concise description, features are described herein as part of the same embodiment or different embodiments, however, it should be understood that the scope of the invention may include embodiments having all or some combinations of the described features. Of course, it should be understood that any of the above embodiments or processes can be combined with one or more other embodiments or processes to provide even further improvements in finding and matching designs and advantages.

[0084] In interpreting the attached claims, it should be understood that the word "comprising" does not exclude the presence of other elements or actions in addition to the elements or actions listed in a given claim; the word "one" or "an" before an element does not exclude the presence of multiple such elements; any figure mark in a claim does not limit the scope of the claim; multiple "devices" may represent the same or different items or implemented structures or functions; unless otherwise specifically stated, any device or part of the disclosed device or part of the claim may be combined together or separated into additional parts. Where one claim refers to another claim, this may indicate the synergistic advantages achieved by the combination of the respective features of these claims. However, the fact that some measures are listed in different claims does not in itself mean that the combination of these measures cannot be used to provide advantages. Therefore, embodiments of the present application may include all valid combinations of claims, wherein each claim may in principle refer to any previous claim unless explicitly excluded by the context.

Claims

1. An injection device, comprising: a syringe having a barrel and a flange; as well as a finger grip, the finger grip being coupled to the syringe, The finger grip portion comprises: i) a base portion defining a first portion of a cavity of the grip portion, the first portion receiving the flange, ii) a collar portion defining a second portion of the cavity of the grip portion, the second portion receiving an end portion of the barrel portion adjacent the flange; and in, The inner surface of the base portion and the inner surface of the collar are formed to provide a first set of first point and / or line contact portions and a second set of second point and / or line contact portions, respectively, the inner surface of the base portion defines a first portion of the chamber, the inner surface of the collar defines a second portion of the chamber, the first set of first point and / or line contact portions are used to engage with the outer surface of the flange, and the second set of second point and / or line contact portions are used to engage with the outer surface of the barrel, wherein The inner surface of the base portion of the grip and the inner surface of the base portion of the grip are smooth or at least have no outwardly extending protrusions for contacting parts of the syringe in the following area, which area contains at least the contact parts included in the first group and the second group.

2. The device according to claim 1, wherein: The engagement between the grip and the syringe is provided only by the contacts included in the first and second sets of contacts, or a subset thereof.

3. The device according to claim 1 or 2, wherein: The first contact portion and the second contact portion are formed of line contacts.

4. The device according to any one of claims 1 to 3, wherein: Through the base portion, there is a tight connection between the flange of the syringe and the grip, and the base portion is configured to provide simultaneous direct contact of each of the first contact portions included in the first subset with the outer surface of the flange, and wherein, through the collar portion, there is a looser connection between the barrel of the syringe and the grip, and the collar portion is configured to enable only a limited subset of the second contacts included in the second group to be in simultaneous direct contact with the barrel during normal operation.

5. The device according to any one of claims 1 to 3, wherein: Through the collar portion, there is a tight connection between the barrel of the syringe and the gripping portion, and the collar portion is configured to provide simultaneous direct contact of each of the second contact portions included in the second subset with the outer surface of the barrel, and wherein, through the base portion, there is a looser connection between the flange of the syringe and the gripping portion, and the base portion is configured to enable only a limited subset of the first contacts included in the first group to be in simultaneous direct contact with the flange during normal operation.

6. The device according to claim 4 or 5, wherein: A maximum play between the non-engaging first contact portion and the flange or the non-engaging second contact portion and the barrel portion is in the range of 50 μm to 400 μm, preferably in the range of 50 μm to 300 μm.

7. Apparatus according to any one of the preceding claims, wherein: The contact wire is provided by one or more of the following: a tangential contact between an outer surface of the flange or barrel of the syringe and one face of a multi-faceted portion of the inner surface of the collar portion or base portion, or The contact portion between the outer surface of the flange or barrel of the syringe and the apex of the curved portion of the inner surface of the bent or curved collar portion or the base portion or one of the intersections between two faces of the multi-faceted portion of the inner surface of the bent or curved collar portion or the base portion.

8. Apparatus according to any one of the preceding claims, wherein: The number of first contact portions for engaging the flange is equal to four.

9. Apparatus according to any one of the preceding claims, wherein: The number of the second contact portions for engaging the barrel portion is between 3 and 5, for example, 3 or 5.

10. The device according to the preceding claim, wherein The number of the second contact portions for engaging the barrel portion is three.

11. Apparatus according to any one of the preceding claims, wherein: The grip portion further includes a stop lug to limit the release of the piston from the barrel portion.

12. Apparatus according to any one of the preceding claims, wherein: The gripping portion is an integrally formed component.

13. Apparatus according to any one of the preceding claims, wherein: The syringe is filled with medication.

14. A packaged injection device comprising an injection device according to any one of the preceding claims, wherein: The exterior of the injection device is sterilized.

15. A finger grip configured to couple with a syringe, the syringe comprising a barrel and a flange, preferably the finger grip is a finger grip according to any one of the preceding claims, the finger grip comprising at least: a base portion of the grip, the base portion of the grip defining a first portion of a cavity of the grip, the first portion being adapted to receive the flange, and a collar portion of the grip portion, the collar portion of the grip portion defining a second portion of the cavity of the grip portion, the second portion being adapted to receive an end portion of the barrel portion adjacent to the flange, wherein the inner surface of the base portion and the inner surface of the collar are formed to provide a first set of first point and / or line contact portions and a second set of second point and / or line contact portions, respectively, the inner surface of the base portion defines a first portion of the chamber, the inner surface of the collar defines a second portion of the chamber, the first set of first point and / or line contact portions are used to engage with the outer surface of the flange, the second set of second point and / or line contact portions are used to engage with the outer surface of the barrel, and Wherein, the inner surface of the base portion of the grip and the inner surface of the base portion of the grip are smooth or at least have no outwardly extending protrusions for contacting a portion of the syringe in the following area, which area at least includes the contact portions included in the first group of contact portions and the second group of contact portions.

16. A method of manufacturing a finger grip configured for coupling with a syringe comprising a barrel and a flange; the method comprising forming a plastic composite using a mold, the mold configured to define: a base portion of the grip, the base portion of the grip defining a first portion of a cavity of the grip, the first portion being adapted to receive the flange, and a collar portion of the grip portion, the collar portion of the grip portion defining a second portion of the cavity of the grip portion, the second portion being adapted to receive an end portion of the barrel portion adjacent to the flange, in, The mold is configured such that an inner surface of the base portion and an inner surface of the collar are formed to provide a first set of first point and / or line contacts, the inner surface of the base portion defining a first portion of the cavity, and an inner surface of the collar defining a second portion of the cavity, the first set of first point and / or line contacts being used to engage with an outer surface of the flange, and the second set of second point and / or line contacts being used to engage with an outer surface of the barrel, respectively, and Wherein, the mold is configured so that the inner surface of the base portion of the grip and the inner surface of the base portion of the grip are smooth or at least have no outwardly extending protrusions for contacting a portion of the syringe in the following area, which area at least includes the contact portions included in the first group of contact portions and the second group of contact portions.

17. A method of manufacturing a packaged injection device, the packaged injection device preferably being The packaged injection device of claim 14, the method comprising: a) providing a syringe comprising a barrel and a flange; b) filling the syringe with a drug; c) providing the finger grip, the finger grip comprising: a base portion defining a first portion of a cavity of the grip, the first portion being adapted to receive the flange; and a collar portion defining a second portion of the cavity of the grip, the second portion being adapted to receive an end portion of the barrel adjacent to the flange, wherein an inner surface of the base portion and an inner surface of the collar are formed to provide a first set of first point and / or line contacts and a second set of second point and / or line contacts, respectively, the inner surface of the base portion being adapted to contact the cavity The first portion of the syringe is defined by the inner surface of the collar, the second portion of the chamber is defined by the inner surface of the collar, the first group of first point and / or line contacts are used to engage with the outer surface of the flange, and the second group of second point and / or line contacts are used to engage with the outer surface of the barrel, and wherein the inner surface of the base portion of the grip and the inner surface of the base portion of the grip are smooth or at least have no outwardly extending protrusions for contacting with a portion of the syringe in the following area, which area at least includes the contact portions included in the first group of contact portions and the second group of contact portions; d) coupling the finger grip to the syringe to form an injection device comprising at least the syringe and the finger grip coupled to the syringe; e) sterilizing the exterior of the injection device by a process comprising exposure to a gaseous sterilant; f) arranging the injection device in a package; and g) sealing the package, wherein: The sterilization is carried out after the filling and the coupling.

18. The method according to the preceding claim, wherein: After e) a further sterilization comprising exposure to a gaseous sterilant or said sterilization e) is carried out.

Citation Information

Patent Citations

  • Injection device for drug delivery and packaging for the injection device

    US20210060258A1