Finger grip

Abstract

An injection device (1) is provided, comprising a syringe (10) having a barrel (11) and a flange (12), and a finger grip (100) coupled to the syringe. The finger grip comprises a base (104) for receiving the flange and a collar (103) for receiving an end portion of the barrel adjacent to the flange. The inner surfaces of the base portions (110, 120) and the collar (130) each provide a first set (C1) of first point contact portions and / or first line contact portions for engaging the outer surface of the flange, and a second set (C2) of second point contact portions and / or second line contact portions for engaging the outer surface of the barrel. The inner surface is smooth or has no outwardly extending protrusions for contacting the syringe. The contact portions may be loose with respect to the flange and / or the barrel.

Description

Technical Field

[0001] Aspects of the present disclosure relate to injection devices for drug delivery. In particular, the present disclosure generally relates to a finger grip accessory for coupling to an injection device, an assembly of an injection device and a finger grip accessory coupled to the injection device, a packaged sterilized injection device pre-filled with a drug, and a method of manufacture.

Background Art

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

[0003] Often, syringes are commercially available in a pre-filled form with a set dosage of drug pre-supplied internally, or the syringe is empty and intended to be filled by an end-user from a vial or other drug source when drug administration is desired.

[0004] Generally, a syringe comprises a barrel portion for holding a drug. Often, the distal end of the barrel is typically configured by a hub to couple the barrel to a cannula. When the hub is coupled to the syringe, a fluid connection between the needle and the syringe is established, thereby enabling fluid from the syringe to be injected via the needle.

[0005] A plunger rod can be inserted through the proximal end of the opening of the syringe barrel. A user can administer the drug by manually applying force to the plunger.

[0006] Commercially available syringes often comprise a flange. This flange is generally provided around the proximal end of the opening of the syringe barrel and extends radially therefrom to form a finger rest for operating the device.

[0007] To improve the grip, usability, and / or ergonomics of a syringe, it is known to attach a finger grip component to the device. The finger grip is sometimes also referred to as a "backstop". The finger grip can have a radial length greater than the length of the flange of the barrel. Alternatively or additionally, the finger grip may have a more ergonomic surface for the user, for example for the purpose of reducing user fatigue. To achieve a stable connection with the device, the finger grip is generally configured to engage one or more of a flange or a portion of the barrel.

[0008] Finger grips can be provided in a plurality of configurations. Known variants include components configured to couple with the device along the axial direction of the barrel, for example by sliding along the barrel from the proximal end towards the flange. Further, components are also known that couple to the device radially, for example by snap-fitting onto the barrel and / or sliding along a radially extending flange. Alternative variants include multi-component grips that can be assembled (e.g., click-fitted) around the syringe.

[0009] For the integrity of the drug and the safety of the patient, it is important to sterilize the syringe sufficiently. Sterilization can be carried out in multiple steps. For example, in an assembly process including a pre-filling stage (such as sterilization of an empty barrel and / or plunger) and a post-filling stage (such as external sterilization of an assembled pre-filled syringe).

[0010] Typically, external sterilization is carried out after the syringe is fully assembled and optionally filled, and / or after it is at least partially positioned within the final packaging.

[0011] There can be multiple challenges / limitations with external sterilization. For example, sterilization by radiation or temperature may not be appropriate in some instances, such as for drugs that are susceptible to being affected. When sterilizing with disinfectants (typical examples being gases such as steam, NOx, or ethylene oxide), it can be difficult to achieve the desired or desired level of sterilization for the external surfaces of the syringe and / or assembled components. Specifically, effectively sterilizing the surface between the syringe and parts such as finger grips that are coupled to the syringe still remains a challenge.

[0012] Patent Document 1 discloses an injection device comprising a syringe having a barrel and a flange, and a backstop configured to be coupled to the syringe adjacent to the flange. This backstop has an inner surface that generally extends around at least a portion of the syringe, and this inner surface comprises at least one protrusion. This at least one protrusion extends in a direction away from the inner surface and is configured to allow or facilitate the passage of an air flow through the space between the aforementioned inner surface and the syringe by engaging with the flange and / or the barrel. These protrusions can contribute to a local reduction in the occluded surface area between the backstop and the barrel and / or the flange.

Prior Art Documents

Patent Documents

[0013]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0014] The object of the present disclosure is to further improve the access of gas between a syringe and a finger grip accessory when associated with the syringe, and to provide a solution that realizes at least acceptable or even improved mechanical stability during normal use. As detailed below in this specification, the present disclosure provides an injection device with a reduced or even eliminated occluded outer surface area. Further, this device provides compatibility with conventional mechanized assembly lines and / or compatibility with ease of (mass) manufacturability of the grip portion, specifically compatibility with molding methods.

Means for Solving the Problems

[0015] Aspects of the present disclosure relate to a finger grip accessory for coupling to an injection device, and an assembly of a syringe and the finger grip accessory. Further, the present disclosure provides a packaged injection product, specifically an assembly of a finger grip accessory and a syringe device. This syringe can be pre-filled with a drug and / or can be exposed to a gaseous sterilant even when pre-filled or partially packaged. Further, the present disclosure provides a method of manufacturing a grip and a method of manufacturing a packaged injection product.

[0016] 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 can be empty.

[0017] The finger grip comprises at least a base portion defining a first part of the grip cavity for receiving the flange, and a collar portion defining a second part of the grip cavity for receiving the end portion of the barrel adjacent to the flange. To improve the ergonomics, haptics, and / or operability of the device, the grip may comprise a first finger rest portion and a second finger rest portion extending laterally from the grip, such as from the sides of the base and / or collar.

[0018] To achieve a mechanically secure connection between the finger grip and the syringe, the inner surface of the base portion defining the first part of the cavity and the inner surface of the collar defining the second part of the cavity are each formed to provide a first set of first contact portions for engaging the outer surface of the flange and a second set of second contact portions for engaging the outer surface of the barrel. It will be appreciated that these contact portions, consisting of the first set and the second set, are each distributed around the periphery of the barrel for receiving the flange. For example, to achieve a stable connection with the flange, the first set of contact portions comprises contact portions configured to engage the bottom and top surfaces of the engaged flange. Typically, these contact portions are distributed so as to exclude in-plane contact regions during a complete connection. For example, the barrel bore can be configured to achieve a snap-fit relationship to reduce the likelihood of the grip accidentally coming off during operation, such as during operation.

[0019] In order to minimize the overall contact area between the grip and the syringe, these contact portions can be configured as what is called a line contact portion, a point contact portion, or a combination thereof. Advantageously, by configuring the grip so that the coupling with the syringe is realized by the point contact portion and / or the line contact portion, the overall contact area between the grip and the syringe, specifically the in-plane contact area, is minimized. Therefore, advantageously, even when the grip and the syringe are in a coupled state, the outer surfaces of the syringe and the grip as finger grips remain available for gas access through the passages / spaces formed between the contact portions, for example, for sterilization using gaseous agents such as NOx, ethylene oxide, or any other suitable agent known in the art. In some variants, both the first contact portion and the second contact portion consist of line contact portions. Preferably, the orientation of these line contact portions is such that, in terms of color, the contact portions are aligned (parallel) in the axial direction of the barrel, and at the base, these lines are aligned with the lateral coupling direction / sliding movement of the grip on the syringe.

[0020] In a highly preferred variant, the inner surface surrounding the cavity, specifically at least the respective inner surfaces of the base portion of the grip and the inner surface of the base portion of the grip, is smooth or has no outwardly extending protrusions for contacting at least a plurality of portions of the syringe over a zone including the contact portions included in the first and second sets. Advantageously, by reducing the number of outwardly extending protrusions and / or achieving a smooth surface finish, the number of corners, ridges, irregularly shaped portions, and / or shielded surface portions where contaminants can adhere, for example, at the edges or acute angle portions located at the base of the outwardly extending protrusions, is reduced. Furthermore, by minimizing the roughness and / or eliminating the presence of protrusions, one or more manufacturing steps of the grip, including filling the mold and removing it from the mold, are alleviated.

[0021] Advantageously, the grip can be manufactured as a single piece, as opposed to an assembly of two or more assembled (e.g., glued) sub-parts. The term smooth is understood to include points having surfaces that gradually slope, bends, folds, and / or intersections of two or more sloped surfaces (e.g., intersections of adjacent planar surfaces).

[0022] To improve operability, the grip can be provided with one or more finger rest portions. As is known in the art, these portions increase the accessible surface area for manually operating the device. For this purpose, the grip can provide at least a first finger rest portion and a second finger rest portion. For example, these finger rest portions can extend laterally from the grip, such as from a collar or base portion.

[0023] Advantageously, the engagement between the grip and the syringe can be achieved only by contact portions or subsets of contact portions such as those included in a first set of contact portions and a second set of contact portions. By doing so, during normal use, it can be achieved that the opposing surfaces of the grip and the syringe (excluding line or point contact portions) are separated by a gap.

[0024] In some variations, the grip is configured, shaped, and dimensioned such that most or even all of the contact portions actually engage the syringe. However, it will be understood that not all contact portions need to engage the syringe simultaneously upon connection.

[0025] In some variations, a separation distance is left between some of the contact portions and the syringe upon full connection. For example, a separation distance is left between a flange and the apex of a contact portion located at a portion of the base portion facing the upper surface of the flange.

[0026] Specifically, in one variant form, there is a tight coupling between the flange of the syringe and the base portion of the grip, and a looser coupling between the color of the grip and the barrel of the syringe. In another variant form, the grip is configured such that there is a close coupling between the barrel of the syringe and the color portion of the grip, and a looser coupling between the flange of the syringe and the base portion of the grip. With respect to both of these configurations, the inventors noticed that the mechanical stability can be excellent, and the slack between the corresponding parts is essentially negligible or at least tolerable during normal operation.

[0027] Therefore, in a preferred variant form, the base portion is configured such that each first contact portion included in the first subset forms a simultaneous contact portion with the outer surface of the flange, thereby creating a tight coupling between the flange of the syringe and the grip, and the color portion is configured such that only a limited subset of the second contact portions included in the second set can be in a simultaneous direct contact state with the barrel during normal operation, thereby creating a looser coupling between the barrel of the syringe and the grip.

[0028] In another preferred variant form, the color portion is configured such that each second contact portion included in the second subset forms a simultaneous direct contact portion with the outer surface of the barrel, thereby creating a tight coupling between the barrel of the syringe and the grip, and the base portion is configured such that only a limited subset of the first contact portions included in the first set can be in a simultaneous direct contact state with the flange during normal operation, thereby creating a looser coupling between the flange of the syringe and the grip.

[0029] The maximum slack (distance) between the first contact part and the flange in the non-engaged state, or between the second contact part and the barrel in the non-engaged state, affects the gas flow resistance between these parts during, for example, sterilization. The greater this slack, the lower the flow resistance can be. In order to minimize the possibility of affecting the mechanical stability of the joint, the slack is preferably less than about 0.8 mm. Preferably it is less than 0.4 mm, and most preferably it is in the range of 50 - 300 μm.

[0030] In yet another variant, there are loose joints for both the flange and the barrel. In such a variant, the grip is configured such that only a limited subset of the first and second contact parts, such as those included in the first set and the second set, can be in simultaneous direct contact with the flange or the barrel during normal operation. The somewhat loose (non-tight) configuration of the joints for both the barrel and the flange allows for further improvement of gas access between the syringe and the flange, while the inventors have noticed that acceptable mechanical stability can still be achieved, especially as long as the slack is 0.8 mm or less, preferably 0.4 mm or less, and most preferably 0.3 mm or less.

[0031] The total number of the first contact parts for engaging with the flange is preferably as small as possible. Advantageously, the number can be reduced to 4 or less. Typically, the first set of contact parts consists of two (or more) contact parts for engaging with the upper surface of the flange and two (or more) contact parts for engaging with the bottom surface of the flange.

[0032] The total number of the second contact parts for engaging with the barrel is preferably as small as possible. Generally, the number of line contact parts included in the second set is 10 or less. Preferably it is 7 or less. Advantageously, the number of the second contact parts for engaging with the barrel can be reduced to 5 or 3 without impairing the mechanical stability of the joint.

[0033] In some variations, the grip further comprises a backstop, such as a tab, for limiting removal of the plunger from the barrel.

[0034] The present disclosure further provides a finger grip configured to couple to a syringe comprising a barrel and a flange, preferably a finger grip as defined herein. The finger grip comprises at least a base portion of the grip defining a first portion of the grip cavity for receiving the flange, and a collar portion of the grip defining a second portion of the grip cavity for receiving an end portion of the barrel adjacent the flange, and preferably further comprises at least a first finger rest and a second finger rest extending laterally from the grip. 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 are each formed to provide a first set of first contact portions for engaging the outer surface of the flange and a second set of second contact portions for engaging the outer surface of the barrel. The inner surface of the base portion of the grip and the inner surface of the base portion of the grip are smooth or have at least no outwardly extending protrusions for contacting multiple portions of the syringe, over a zone including at least the contact portions included in the first set of contact portions and the second set of contact portions.

[0035] These and other features, aspects, and advantages of the devices, systems, and methods of the present disclosure will be better understood from the following description, the appended claims, and the accompanying drawings.

Brief Description of the Drawings

[0036]

Figure 1

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Modes for Carrying Out the Invention

[0037] The terms used to describe certain embodiments are not intended to limit the present invention. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. The term "and / or" includes any and all combinations of one or more of the associated listed items. It will be understood that the terms "comprises" and / or "comprising," while specifying the presence of stated features, do not preclude the presence or addition of one or more other features. Further, if a particular step of a method is described as following another step, unless otherwise specified, that particular step can follow immediately after said other step, or one or more intermediate steps may be performed before the implementation of that particular step. Similarly, when the connection between structures or components is described, unless otherwise specified, this connection may be established directly, or may be established through intermediate structures or components.

[0038] Hereinafter, embodiments of the present invention will be described in more detail with reference to the accompanying drawings in which the embodiments of the present invention are illustrated. In these drawings, the absolute and relative sizes of systems, components, layers, and regions may be exaggerated for clarity. In some cases of the present invention, embodiments may be described with reference to schematic and / or cross-sectional views of idealized embodiments and intermediate structures. In the description and drawings, like numbers refer to like elements throughout. Relative terms and their derivatives are to be construed as indicating the directions shown in the drawings in the directions or with respect to which they are being described. These relative terms are for convenience in description and do not require that the system be constructed or operated in a particular direction unless otherwise specified.

[0039] Figure 1 shows a side view of an injection device 1 for drug delivery according to the present disclosure. The device comprises a syringe having a barrel 11 and a flange 12. The flange 12 is provided along the proximal end 11p of the barrel. The distal end 11d on the opposite side is shown to comprise a hub 13 for receiving a cannula (not shown). The device 1 further comprises a finger grip 100. This grip is shown in the fully engaged position. The grip engages the flange from the upper face 12-1 and the lower face 12-2 of the flange. Further, the grip also engages a portion of the outer surface of the barrel at the proximal end. The finger grip 100 is fitted around a plunger 14 inserted into the barrel. The grip does not contact the plunger during normal operation. The plunger is slidable within the barrel along its central longitudinal axis A. Advantageously, as best seen in Figure 17, the grip can function as a backstop, for example by means of a tab 50. This backstop allows the passage of the plunger rod 14r but restricts the movement of the plunger when it engages the plunger base 14b.

[0040] The radially extending wing-like portions 101, 102 of the finger grip portion provide an extended surface area for the user to operate the device. As will be detailed hereinafter, this grip can be provided in a plurality of deformed configurations including a deformed configuration in a tightly connected state with respect to both the barrel and the flange, a deformed configuration with a tight connection to the flange and a looser coupling with the barrel, a deformed configuration with a tight connection to the barrel and a looser coupling with the flange, and a deformed configuration with a somewhat loose connection to both the flange and the barrel.

[0041] Figures 2 to 21 show detailed views of aspects related to embodiments of the injection device 1, the finger grip 10, and the connection between the grip and the syringe. Figures 11 to 15 show details of aspects of an embodiment configured to achieve a tight connection between the grip on one side and the barrel and flange on the other side, and Figures 16 to 21 show aspects of a variant form having one looser connection portion (flange or barrel) with the syringe. It will be understood that the variant forms with loose connections to both the barrel and the flange include corresponding aspects as appropriate.

[0042] As can be best seen, for example, in FIGS. 5, 8, and 10, the grip 100 can be understood as consisting of two interconnected parts, including a base portion 104 that provides a recess for receiving the flange 12 and a collar portion 103 that provides a recess for receiving the barrel 11, at least conceptually. These recesses are fluidly connected to form a continuous cavity.

[0043] FIG. 5 shows a detailed side view of the device focused on the periphery of the finger grip portion 100 as engaging the proximal end 11p of the barrel 11 and the flange 12 in the fully engaged position. FIG. 2 shows a cross-sectional bottom view of the injection device just below the collar, with the plunger omitted so as not to obscure the details here. FIG. 4 shows a corresponding plan view. FIG. 3 shows a plan view of the finger grip in the empty form (with no syringe inserted). FIG. 6 shows a view of the configuration shown in FIG. 5 without the syringe. FIGS. 7 and 8 show upper and lower perspective views of the empty grip. FIGS. 9 and 10 show side views and cross-sectional side views, respectively, of the configuration shown in FIG. 5.

[0044] As shown in FIG. 6, the grip 100 includes a cavity 150 for receiving a syringe. The cavity can be understood to include a first portion 151 (birth) for receiving the flange 12 of the syringe and a second cavity portion 152 (birth) that is fluidly connected to the first portion and for receiving the barrel 11 along the end portion 11p of the barrel 11. As shown, the first portion of the cavity 151 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 cavity for receiving the barrel of the syringe is laterally defined by the inner surface 130 of the collar portion 103 that extends downward in a direction along the central axis "A" from the wall portion that defines the first cavity portion. This collar typically extends over a length of at least 2 mm, typically within the range of 2 to 10 mm, for example within the range of 3 to 6 mm, for example about 5 mm. The longer the length of the collar portion, the more stable the connection with the syringe can be. To minimize the effect on the gas flow resistance between the collar and the barrel, their overlapping portion is preferably less than 10 mm.

[0045] Advantageously, it should be understood that the grip forms an open structure to maximize the access of gas to the syringe. For this purpose, the wall portion defining the cavity may comprise one or more apertures. As can be best seen in FIGS. 6-10, the cavity 151 can be understood as being laterally defined by opposing side wall portions 105, 106. These side wall portions typically do not engage with the flange or any other part of the syringe, thus minimizing the in-plane contact area. At least one of the side wall portions 105 comprises a first aperture a1 dimensioned to receive the flange from the lateral direction. The opposing side wall portion 106 may typically comprise a second aperture a2 that is relatively smaller than the first aperture to allow gas to pass through the cavity. The wall portion defining the upper part of the cavity 151 comprises another aperture a4 shaped to allow the passage of the plunger rod. The collar is typically shaped / dimensioned to partially surround the peripheral portion of the barrel, leaving an aperture a3 dimensioned to allow the insertion of the barrel from the lateral direction.

[0046] Similar to the wall portion defining the first part of the cavity 151, the collar may comprise one or more additional apertures to further improve the passage of gas through the cavity. The apertures a1-a4 are shown in FIGS. 7, 8, and 10. FIGS. 3 and 7 further show the residual marks m due to injection molding.

[0047] The grip comprises a plurality of contact portions C1-1, C1-2, C1-3, C1-4, C2-1, C2-2, C2-3, C2-4, C2-5 for engaging at opposing points along the outer surface of the syringe. In each of the embodiments shown hereinafter in this specification, the first set of contact portions C1 (for engagement with the flange) and the second set of contact portions C2 (for engagement with the barrel) are embodied in the form of contact lines. As shown, note that the inner surfaces 110, 120, and 130 do not substantially have protrusions.

[0048] The contact line can be realized in various ways. In one variant, as can be best seen in, for example, FIGS. 11A, 11B, 12A, 12B, 13, 14, 15, and 16, these contact portions are the tangential contact portion between the outer surface of the barrel or flange of the syringe and one of the polyhedral portions of the inner surface of the base portion or collar portion (e.g., the surface located at its central portion), the contact portion between the outer surface of the barrel or flange of the syringe and one of the vertices of the bent portion (or folded portion) of the inner surface of the base portion or collar portion, and / or one or more of the bent portions or intersections located between two of the polyhedral portions of the inner surface of the bent portion or folded portion of the base portion or collar portion.

[0049] As shown in FIGS. 13 to 15, the line contact portion can be realized by a portion of the inner surface oriented at an angle α (α1, α2, α3) with respect to the upper and lower surfaces of the flange to be received. Typically, this angle is in the range between 1° and up to 45°. Preferably, this angle is in the range of about 5 degrees to about 20 degrees. When the syringe is coupled to the grip, a substantially linear contact portion is formed. It has been found that sufficient access of gas is achieved with the angle within the above specific range. In some embodiments, as shown in FIGS. 14 to 15 for example, the inner surface may be composed of two or more inclined regions that converge at an intersection providing a linear apex. The inclinations in the schematic views "i" and "ii" may be exaggerated for clarity.

[0050] The contact portion between the inner surface 130 of the collar 103 and the barrel 11 of the syringe is realized without using a protrusion. The contact portion without a protrusion can be realized in a plurality of ways.

[0051] For example, the linear contact portion can be realized by the birth (cavity portion 152) of a barrel having a polygonal cross-section. In contrast to the case of providing a protrusion, the inner surface of the collar 103 can be configured to include a plurality of surfaces arranged at an angle to each other. When the barrel is inserted, some or each of these planes can form a tangential contact portion with the barrel. The number of planes is three or more. In one embodiment, as can be best seen in FIGS. 11A and 17B for example, the collar includes five planes 130-1, 130-2, 130-3, 130-4, 130-5 (see FIG. 17), and these planes are oriented to realize something somewhat similar to a hexagonal barrel birth that opens along one side. Since the barrel has a round shape, the overall in-plane contact area can be negligible.

[0052] In another or further variant, the barrel birth can be oval in shape. As can be best seen in FIG. 12B, 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 contact portions c2-1, c2-2, c2-3 with the barrel 11. The total contact area between the barrel and the collar can be negligible. Note the gas passage P between the barrel and the collar.

[0053] It should be understood that the barrel birth is not to be construed as limited to the illustrated configuration, and it will be understood that other polygonal cross-sections or smooth curved cross-sections (such as square, octagonal, elliptical, etc.) are contemplated.

[0054] Figure 16 shows details of a variant configured such that the grip achieves a loose contact with the barrel. Specifically, the collar is dimensioned somewhat larger than the cross-sectional dimensions of the barrel it is to receive. In particular, the flat contact surfaces 130-1 to 130-5 are positioned such that up to three simultaneous contact areas can be formed between the collar and the barrel. In Figure 16, the barrel is shown in its end position and two simultaneous contact lines c2-1, c2-2 are achieved. Some space or slack "s" exists along both ends.

[0055] Figure 18 shows details of another variant configuration where the grip is configured to form a loose contact with the barrel. Compared to the variant shown in Figures 12A - 12B, this birth is elliptical and thus only two simultaneous contact areas can be achieved with respect to barrel 11 when fully engaged.

[0056] This somewhat loose fit improves gas access between the barrel and the finger grip. Typically, the slack is 1 μm or more, for example 5 μm or more. Generally, the slack is 300 μm or less, for example 200 μm or less, for example between 5 - 300 μm or between 1 - 200 μm. The inventors have noticed that within this specified range, the slack is such that the end user will not substantially notice it during normal handling operations.

[0057] Of course, this grip can be configured such that the birth matches the outer diameter of the barrel it is to receive (see Figures 11, 12, and 17), thereby forming a total of five contact areas (including three line contact areas) with barrel 11.

[0058] Figures 19, 20, and 21 show details of an aspect of a configuration where the grip is dimensioned such that the connection to the flange is looser. Figures 19 and 21A - 21C are partial side views of an injection device 1 for administering a drug. Figure 20 shows the same grip but without the syringe here.

[0059] As shown, the cavity portion 151 for receiving the flange, which is defined between the inner surfaces 110 and 120, is dimensioned large 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. Thus, a space or slack S is obtained between the upper surface 12-1 and the surface 110. This slack improves gas access between the flange and the finger grip. Typically, the slack is 1 μm or more, for example 5 μm or more. Generally, the slack is 400 μm or less, 300 μm or less, for example 200 μm or less, for example between 5 and 300 μm or between 1 and 200 μm. The inventors have noticed that within this specified range, the slack is such that the end user is substantially unaware of it during normal handling operations.

[0060] Advantageously, by dimensioning the barrel burst and / or the flange burst large, it is possible to accommodate common syringe manufacturing tolerances. Advantageously, the grip can be manufactured by utilizing conventional manufacturing methods including, but not limited to, molding such as injection molding (and even as a single piece). Without wishing to be bound by theory, the ease of manufacture is thought to be at least partially related to the formation of the smooth inner surface of the grip as disclosed herein. Specifically, the absence of outwardly extending protrusions (ribs, piles, domes) is thought to facilitate filling of the mold and removal of the molded product from the mold.

[0061] This method typically involves forming a plastic molding material, which is typically a thermoplastic molding material, and using a mold configured to define a first portion of a grip cavity for receiving a flange, a base portion of the grip that defines the first portion of the grip cavity, a collar portion of the grip that defines a second portion of the grip cavity for receiving an end portion of a barrel adjacent to the flange, and at least a first finger rest and a second finger rest that extend laterally from the grip. The mold is configured such that an inner surface of the base portion that defines the first portion of the cavity and an inner surface of the collar that defines the second portion of the cavity each provide a first set of first contact portions for engaging an outer surface of the flange and a second set of second contact portions for engaging an outer surface of the barrel, and the mold is configured such 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 have no outwardly extending protrusions for contacting a plurality of portions of the syringe.

[0062] Advantageously, an injection device as disclosed can be pre-filled with a medicament, such as an ophthalmic medicament for example.

[0063] Advantageously, the medicament can be packaged, in which case the outside of the injection device is sterilized and the syringe can be empty or pre-filled.

[0064] The packaged injection device is provided by a method which comprises: a) providing a syringe having a barrel and a flange; b) filling the syringe with a medicament if desired; c) providing a finger grip which comprises a base portion defining a first part of a grip cavity for receiving the flange, a collar portion defining a second part of the grip cavity for receiving an end portion of the barrel adjacent to the flange, and at least a first finger rest portion and a second finger rest portion extending laterally from the grip, wherein an inner surface of the base portion defining the first part of the cavity and an inner surface of the collar defining the second part of the cavity are formed to respectively provide a first set of first contact portions for engaging an outer surface of the flange and a second set of second contact portions for engaging an outer surface of the barrel, and the inner surface of the base portion of the grip and the inner surface of the base portion of the grip are smooth or have no outwardly extending protrusions for contacting a plurality of parts of the syringe at least; d) forming an injection device comprising at least the syringe and the finger grip coupled to the syringe by coupling the finger grip to the syringe; e) sterilizing an exterior of the injection device by a process including exposure to a gaseous sterilant; f) placing the injection device within a package; and g) sealing the package. Advantageously, the sterilization can be carried out after filling and / or after coupling. Optionally, the sterilization or further sterilization can include exposure to a gaseous sterilant. Further optionally, the sterilization can be carried out with the product already partially or fully disposed within the package.

[0065] For the purposes of a clear and concise description, features are described herein as part of the same or separate embodiments, but it will be understood that the scope of the invention may include embodiments having all or some combination of the features described. Of course, it should be understood that any one of the above embodiments or processes may be combined with one or more other embodiments or processes to provide further improvements in the discovery and matching of designs and advantages.

[0066] In the interpretation of the appended claims, it should be understood that the term "comprising" does not exclude the presence of other elements or acts than those listed in a given claim. Also, the article "a" preceding an element does not exclude the presence of a plurality of such elements. Reference signs in the claims do not limit their scope in any way. A plurality of "means" may be represented by the same or different items, or structures or functions to be implemented. Any device of the present disclosure or a part thereof can be combined together or separated into other parts as long as there is no specific designation. When one claim refers to another claim, this may imply a synergistic advantage realized by the combination of their respective features. However, even if some means are described in different claims, the fact alone does not imply that these means cannot be used advantageously in combination. Therefore, these embodiments may include any valid combination of the claims, and each claim may, in principle, refer to the preceding claims unless clearly excluded within the context.

Description of Reference Signs

[0067] 1 Injector device 10 Finger grip 11 Barrel 11d Distal end 11p Proximal end, terminal end 12-1 Upper surface 12-2 Lower surface 12 Flange 13 Hub 14 Plunger 14b Plunger base 14r Plunger rod 50 Tab 100 Finger grip, finger grip portion 101 Wing portion 102 Wing portion 103 Collar portion, collar 104 Base portion 105 Side wall portion 106 Side wall portion 110 Inner surface, inner side 120 Inner surface, inner side 130 Inner surface, inner side 130-1 Plane, flat contact surface 130-2 Plane, flat contact surface 130-3 Plane, flat contact surface 130-4 Plane, flat contact surface 130-5 Plane, flat contact surface 150 Cavity 151 First portion, cavity, cavity portion, birth 152 Second portion, cavity portion, second cavity portion, birth A Central longitudinal axis a1 First aperture a2 Second aperture a3 Aperture a4 Aperture C1 First contact portion set Cl-1 Contact portion Cl-2 Contact portion Cl-3 Contact portion Cl-4 Contact portion C2 Second contact portion set C2-1 Contact portion C2-2 Contact portion C2-3 Contact portion C2-4 Contact portion C2-5 Contact portion m Residual mark P Gas passage S Slack

Claims

1. An injection device, comprising: a syringe having a barrel and a flange; and a finger grip coupled to the syringe, the finger grip comprising: i) a base portion defining a first portion of a cavity of the grip for receiving the flange, and ii) a collar portion defining a second portion of the cavity of the grip for receiving an end portion of the barrel adjacent to the flange, wherein an inner surface of the base portion defining the first portion of the cavity and an inner surface of the collar portion defining the second portion of the cavity each provide a first set of first point contact portions and / or line contact portions for engaging an outer surface of the flange, and a second set of second point contact portions and / or line contact portions for engaging an outer surface of the barrel, and the inner surface of the base portion of the grip and the inner surface of the base portion of the grip are smooth or have at least no outwardly extending protrusions for contacting a plurality of portions of the syringe over a zone including at least the contact portions included in the first set and the second set, a finger grip; An injection device comprising the above.

2. The device according to claim 1, wherein the engagement between the grip and the syringe is achieved only by the contact portions or a subset of the contact portions included in the first set of the contact portions and the second set of the contact portions.

3. The device according to claim 1 or 2, wherein the first contact portions and the second contact portions consist of line contact portions.

4. By configuring the base portion to form simultaneous direct contact portions of each of the first contact portions included in the first subset between the base portion and the outer surface of the flange, a tight coupling exists between the flange of the syringe and the grip, and by configuring the collar portion such that only a limited subset of the second contact portions included in the second set can be in simultaneous direct contact with the barrel during normal operation, a looser coupling exists between the barrel of the syringe and the grip. The device according to any one of claims 1 to 3.

5. By being configured such that the color portion forms simultaneous direct contact portions of each of the second contact portions included in the second subset between the outer surface of the barrel, a tight coupling portion exists between the barrel and the grip of the syringe, and by being configured such that only a limited subset of the first contact portions included in the first set can be in simultaneous direct contact with the flange during normal operation, a looser coupling portion exists between the flange and the grip of the syringe, the device according to any one of claims 1 to 3.

6. The maximum slack between the first contact portion in the disengaged state and the flange or between the second contact portion in the disengaged state and the barrel is in the range of 50 to 400 μm, preferably in the range of 50 to 300 μm, the device according to claim 4 or 5.

7. The line contact portion is a tangential contact portion between the outer surface of the barrel or the flange of the syringe and one surface of the polyhedral portion of the inner surface of the base portion or the color portion, or a contact portion between the outer surface of the barrel or the flange of the syringe and the apex of the bent portion of the inner surface of the base portion or the color portion, or an intersection between two surfaces of the bent portion or the bent portion, or an intersection between two surfaces of the polyhedral portion of the inner surface of the bent portion or the bent portion of the base portion or the color portion The device according to any one of claims 1 to 6, which is realized by one or more of the above.

8. The number of the first contact portions for engaging with the flange is four, the device according to any one of claims 1 to 7.

9. The number of the second contact portions for engaging with the barrel is 3 to 5, for example 3 or 5, the device according to any one of claims 1 to 8.

10. The number of the second contact portions for engaging with the barrel is three, the device according to claim 9.

11. The grip further includes a backstop tab for restricting the plunger from coming off the barrel, the device according to any one of claims 1 to 10.

12. The grip is an integrally formed part, the device according to any one of claims 1 to 11.

13. The device according to any one of claims 1 to 12, wherein the syringe is filled with a medicament.

14. A packaged injection device comprising the injection device according to any one of claims 1 to 13, wherein the exterior of the injection device is sterilized.

15. A finger grip configured to couple to a syringe having a barrel and a flange, preferably a finger grip as defined in any one of claims 1 to 14, wherein the finger grip comprises: a base portion of the grip defining a first portion of the cavity of the grip for receiving the flange; a collar portion of the grip defining a second portion of the cavity of the grip for receiving an end portion of the barrel adjacent to the flange; and at least comprising; an inner surface of the base portion defining the first portion of the cavity and an inner surface of the collar portion defining the second portion of the cavity are each formed to provide a first set of first point contacts and / or first line contacts for engaging an outer surface of the flange, and a second set of second point contacts and / or second line contacts for engaging an outer surface of the barrel; The inner surface of the base portion of the grip and the inner surface of the base portion of the grip are smooth or have at least no outwardly extending protrusions for contacting a plurality of portions of the syringe over a zone including at least the contacts included in the first set of contacts and the second set of contacts.

16. A method of manufacturing a finger grip configured to couple to a syringe having a barrel and a flange, the method comprising the step of forming a plastic molding material using a mold, the mold comprising: a base portion of the grip defining a first portion of the cavity of the grip for receiving the flange; a collar portion of the grip defining a second portion of the cavity of the grip for receiving an end portion of the barrel adjacent to the flange; and comprising; The mold is configured to be formed so as to provide a first set of first point contact portions and / or first line contact portions for engaging the outer surface of the flange respectively by 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, and a second set of second point contact portions and / or second line contact portions for engaging the outer surface of the barrel. The mold is smooth over a zone at least including the contacts included in the first set of the contacts and the second set of the contacts, or has at least no outwardly extending protrusions for contacting a plurality of portions of the syringe, with respect to the inner surface of the base portion of the grip and the inner surface of the base portion of the grip. **Claim 17** A method for manufacturing a packaged injection device, preferably the packaged injection device according to claim 14, comprising: a) providing a syringe comprising a barrel and a flange; b) filling the syringe with a medicament; c) providing the finger grip, the finger grip comprising a base portion defining a first portion of the cavity of the grip for receiving the flange and a collar portion defining a second portion of the cavity of the grip for receiving an end portion of the barrel adjacent to the flange, the inner surface of the base portion defining the first portion of the cavity and the inner surface of the collar portion defining the second portion of the cavity are each formed to provide a first set of first point contact portions and / or first line contact portions for engaging the outer surface of the flange and a second set of second point contact portions and / or second line contact portions for engaging the outer surface of the barrel, and the inner surface of the base portion of the grip and the inner surface of the base portion of the grip are smooth over a zone at least including the contacts included in the first set of the contacts and the second set of the contacts, or have at least no outwardly extending protrusions for contacting a plurality of portions of the syringe. d) forming an injection device comprising at least the syringe and the finger grip coupled to the syringe by coupling the finger grip to the syringe; e) sterilizing the exterior of the injection device by a process including exposure to a gaseous sterilant; f) placing the injection device within a package; g) sealing the package; comprising, wherein the step of sterilizing is carried out after the steps of filling and coupling, a method. **Claim 18** The method of claim 17, wherein the step of sterilizing e), or a further step of sterilizing including exposure to a gaseous sterilant, is carried out after the step of e).

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