CN119604320A - Finger grip - Google Patents

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 includes a base (104) that receives the flange and a collar (103) that receives an end portion of the barrel adjacent the flange. The inner surface (110, 120) of the base portion and the inner surface (130) of the collar provide a first set of first point and/or line contacts (C1) for engaging the outer surface of the flange and a second set of second point and/or line contacts (C2) for engaging the outer surface of the barrel portion, respectively. The inner surface is smooth or free of outwardly extending protrusions for contact with the syringe. The contact with respect to the flange and/or the barrel may be loose.

Description

Finger holding part

Technical Field

Aspects of the present disclosure relate to an injection device for drug delivery. In particular, the present disclosure relates generally to a finger grip accessory for use with an injection device, an injection device and an assembly of finger grip accessories associated therewith, a sterilized injection device pre-filled with a package of a medicament, and a method of manufacture.

Background

Syringes are medical delivery devices for applying a drug to a patient.

Syringes are often sold in pre-filled forms where a set dose of drug has been provided in the syringe, or the syringe is empty and intended to be filled by an end user from a vial or other source of drug when it is desired to administer the drug.

The syringe typically includes a barrel portion for holding the medicament. 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 such that fluid from the syringe can be injected via the needle.

The plunger rod may be inserted through the open proximal end of the syringe barrel. The user may apply the medicament by applying manual force to the piston.

Commercial syringes are typically provided with flanges. A flange is typically disposed about and extends radially from the open proximal end of the syringe barrel to provide a form of finger rest for manipulating the device.

To improve the grip, usability and/or ergonomics of the syringe, it is known to couple finger grip members 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. To provide a stable connection with the device, the finger grip is typically configured to engage one or more of the flange or a portion of the barrel.

The finger grip may be provided in a variety of configurations. Known variants include components configured to couple with the device along an axial direction of the barrel, for example by sliding along the barrel from a proximal end of the barrel towards the flange. Components coupled to the device from a radial direction, for example by sliding along a radially extending flange and/or snapping onto a barrel, are also known. Alternative variations include a multi-part grip that can be assembled (e.g., mated) around the syringe.

For drug integrity and patient safety, it is important that the syringe be adequately sterilized. Sterilization may be performed in multiple stages. For example, during assembly, which includes a pre-filling stage (e.g., sterilization of the hollow barrel and/or the piston) and a post-filling stage (e.g., external sterilization of the assembled pre-filled syringe).

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

External sterilization can present a number of challenges/limitations. For example, sterilization by radiation or temperature may be unsuitable in certain situations (e.g., for sensitive drugs). Sterilization by a fluid sterilant (typically a gas such as steam, NOx or ethylene oxide) may be difficult to achieve a desired or required level of sterilization of the exterior surfaces of the assembled components and/or the syringe. In particular, effective sterilization of the syringe and surfaces between components coupled to the syringe (e.g., finger grips) remains a challenge.

US20210060258A1 discloses an injection device comprising a syringe having a barrel and a flange, and a stopper configured to couple with the syringe adjacent the flange. The stopper includes an inner surface extending generally around at least a portion of the syringe, wherein the inner surface includes at least one protrusion extending away from the inner surface and configured to engage the flange and/or the barrel to allow or facilitate air flow through a space between the inner surface and the syringe. The protrusions may help to locally reduce the occlusion surface area between the stop and the barrel and/or flange.

Disclosure of Invention

The present disclosure aims to provide a solution with a further improved gas passage between the syringe and the finger grip accessory when they are associated, while providing at least acceptable or even improved mechanical stability during normal use. As detailed herein below, the present disclosure provides an injection device having a reduced or even eliminated occlusive outer surface area. The apparatus also provides compatibility with loose (large-scale) manufacturability of conventional mechanized assembly lines and/or gripping members, particularly with molding methods.

Aspects of the present disclosure relate to a finger grip accessory for association with an injection device, and to an assembly of a syringe and a finger grip accessory. Furthermore, the present disclosure provides a packaged injection product, in particular an assembly of a finger grip accessory and a syringe device. The syringe may be prefilled with a drug and/or exposed to a gaseous sterilant (even when prefilled or partially packaged). The present disclosure also provides a method of manufacturing a grip portion and a method of manufacturing a packaged injection product.

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 prefilled with a drug. Alternatively, the syringe may be empty.

The finger grip includes at least a base portion defining a first portion of the 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 the flange. In order to improve the ergonomics, 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).

In order to provide a mechanically reliable coupling between the finger grip and the syringe, the inner surface of the base portion and the inner surface of the collar are formed such that a first set of first contacts for engagement with the outer surface of the flange and a second set of second contacts for engagement with the outer surface of the barrel are provided, respectively, the inner surface of the base portion defining a first portion of the chamber and the inner surface of the collar defining a second portion of the chamber. It will be appreciated that the contacts included in the first and second sets are distributed around the receptacle for receiving the flange and barrel respectively. For example, to provide a stable coupling with the flange, the first set of contacts comprises contacts arranged for engagement with the bottom and top surfaces of the engaged flange. The contacts are typically distributed to exclude flush contact areas during full coupling. To reduce accidental release of the grip, for example during operation, the cartridge receiver may be configured to provide a snap-fit relationship.

In order to minimize the total contact area between the grip and the syringe, the contact may be configured as a so-called line contact, a point contact or a combination thereof. The grip is configured such that coupling with the syringe is achieved by point contact and/or line contact, advantageously minimizing the total contact area (in particular flush contact area) between the grip and the syringe. Thus, even in the coupled state, the grip portion, which is a finger grip, and the outer surface of the syringe may advantageously maintain an air passageway available for implementation through the channel/space formed between the contact portions, for example for sterilization with gaseous reagents (e.g., NOx, ethylene oxide, or any other suitable reagent known in the art). In some variations, the first contact and the second contact are all made up of line contacts. The orientation of the wire contact is preferably such that at the collar the contact is aligned (parallel) with the axial direction of the barrel and at the base the wire is aligned with the lateral coupling direction/sliding movement of the grip onto the syringe.

In a particularly preferred variant, the inner surface of the base portion of the grip surrounding the chamber (in particular, at least the respective 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 contact with portions of the syringe in areas containing at least the contacts comprised in the first and second sets. 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 (e.g., at edges or sharp corners at the base of the outwardly extending protrusions) for contaminant adhesion. In addition, minimizing roughness and/or eliminating the presence of protrusions eases one or more stages of manufacturing the grip (including filling and release from the mold).

Advantageously, the grip portion may be manufactured as a single integral piece, rather than as an assembly of two or more assembled (e.g. glued) sub-components. It should be understood that the term smooth includes surfaces having a gradual slope, a curvature, a fold (fold) and/or an intersection of two or more sloped surfaces (e.g., an intersection of adjacent planar surfaces).

To increase operability, 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 processing of the device. To this end, the grip may provide at least a first finger portion and a second finger portion. The finger rest portion may extend laterally, for example, from the grip portion, for example, from the collar or base portion.

Advantageously, the engagement between the grip portion and the syringe may be provided solely by the contacts comprised in the first set of contacts and the second set of contacts or a subset thereof. In this way, it is achieved that during normal use, the opposed faces of the grip and syringe (excluding the line or point contact) are separated by a gap.

In some variations, the grip may be configured, shaped, sized such that most or even all of the contacts actually engage the syringe. However, it should be understood that not all contacts need to engage the syringe at the same time when coupled.

In some variations, when fully coupled, some of the contacts maintain a separation distance between the syringe and some of the contacts. For example between the flange and the apex of the contact at a portion of the base portion facing the top surface of the flange.

In particular, in one variant, there is a tight coupling between the flange of the syringe and the base portion of the grip, and a loose 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 loose coupling between the flange of the syringe and the base portion of the grip. The inventors found that for both configurations, mechanical stability may be excellent during normal operation, and that play between the corresponding parts may be substantially insignificant or at least acceptable.

Correspondingly, in a preferred variant, there is a tight coupling between the flange and the grip of the syringe by means of a base portion configured to provide simultaneous direct contact of each of the first contacts comprised in the first subset with the outer surface of the flange, and wherein there is a loose coupling between the barrel and the grip of the syringe by means of a collar portion configured to enable simultaneous direct contact of only a limited subset of the second contacts comprised in the second set with the barrel during normal operation.

In another preferred variant, wherein there is a tight coupling between the barrel and the grip of the syringe by means of a collar portion configured to provide simultaneous direct contact of each of the second contacts comprised in the second subset with the outer surface of the barrel, and wherein there is a loose coupling between the flange and the grip of the syringe by means of a base portion configured to enable only a limited subset of the first contacts comprised in the first set to be simultaneously in direct contact with the flange during normal operation.

The maximum play (distance) between the non-engaging first contact and the flange or between the non-engaging second contact and the barrel 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 coupling, the play is preferably no more than about 0.8mm. Preferably below 0.4mm, most preferably in the range 50 μm to 300 μm.

In a further variant, the coupling with the flange and the barrel is loose. In this variant, the grip is configured such that during normal operation only a limited subset of the first and second contact portions comprised in the first and second sets may be in direct contact with the flange (and, respectively, with the barrel) simultaneously. The inventors have found that a somewhat loose (not tight) configuration of the coupling with both the barrel and the flange may further increase the gas passage between the syringe and the flange while still providing acceptable mechanical stability, in particular, as long as the play is not more than 0.8mm, preferably +.0.4 mm, most preferably +.0.3 mm.

The total number of first contact portions 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 a top surface of the flange and two (or more) contacts for engaging a bottom surface of the flange.

The total number of second contact portions for engaging the barrel portion is preferably as low as possible. Typically, the number of line contacts included in the second group is 10 or less. Preferably, 7. Advantageously, the number of second contacts for engaging the barrel may be as low as 5 or even 3 without compromising the mechanical stability of the coupling.

In some variations, the grip portion further includes a stop (e.g., a tab) to limit release of the piston from the barrel.

The present disclosure also provides a finger grip configured for coupling with a syringe, the syringe comprising a barrel and a flange, preferably the finger grip is as defined herein. The finger grip comprises at least a base portion of the grip defining a first portion of the cavity of the grip, the first portion being for receiving the flange, a collar portion of the grip defining a second portion of the 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 extending laterally from the grip, wherein an inner surface of the base portion and an inner surface of the collar are formed such that a first set of first and second contacts are provided, respectively, the inner surface of the base portion defining the first portion of the cavity, the inner surface of the collar defining the second portion of the cavity, the first set of first contacts being for engagement with an outer surface of the flange, the second set of second contacts being for engagement 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 in the following region or at least a second set of contacts for at least the outer contact of the syringe in the region comprising the second set of contacts.

Drawings

These and other features, aspects, and advantages of the apparatus, systems, and methods of the present disclosure will become better understood with regard to the following description, appended claims, and accompanying drawings where:

FIG. 1 provides a side view of an injection device for drug delivery;

FIG. 2 provides a cross-sectional view of an injection device;

FIG. 3 provides a top view of the finger grip;

FIG. 4 provides a cross-sectional top view of the injection portion;

FIG. 5 provides a partial cross-sectional side view of an injection device;

FIG. 6 provides a side view of the finger grip;

FIG. 7 provides a perspective top view of the finger grip;

FIG. 8 provides a perspective bottom view of a finger;

FIG. 9 provides a partial side view of an injection device for drug delivery;

FIG. 10 provides a partial cross-sectional side view of an injection device;

FIGS. 11A and 11B provide cross-sectional bottom views of an injection device;

fig. 12A and 12B provide cross-sectional bottom views of an injection device;

FIG. 13 provides a partial side view of the injection device;

FIGS. 14 and 15 provide detailed views of the apparatus shown in FIG. 13;

FIG. 16 provides a cross-sectional bottom view of the injection device;

FIG. 17 provides a bottom view of the finger grip;

FIG. 18 provides a partial bottom view of the finger grip;

FIG. 19 provides a partial side of an injection device;

FIG. 20 provides a partial side of a finger grip, and

Fig. 21A, 21B and 21C provide side views of the injection device.

Detailed Description

The terminology used to describe the particular embodiments is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The term "and/or" includes any one of the listed items of interest as well as all combinations of one or more. It should be understood that the terms "comprises" and/or "comprising" indicate the presence of stated features, but do not preclude the presence or addition of one or more other features. It should also be understood that when a particular step of a method is described as following another step, unless otherwise indicated, that particular step may directly follow the other step or one or more intervening steps may be performed prior to the performance of the particular step. Similarly, it will be understood that when a connection between structures or components is described, the connection may be established directly or through intermediate structures or components unless otherwise indicated.

The present invention will be described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. In the drawings, the absolute and relative dimensions of the systems, components, layers and regions may be exaggerated for clarity. Embodiments will be described with reference to schematic and/or cross-sectional views of possibly desirable embodiments and intermediate structures of the present invention. Like reference numerals refer to like elements throughout the specification and drawings. Related terms and derivatives of related terms should be understood to mean as described at the time or as shown in the drawings in question. Unless otherwise indicated, these relative terms are for convenience of description and the system need not be constructed or operated in a particular orientation.

Fig. 1 provides a side view of an injection device 1 for drug delivery according to the present disclosure. The apparatus comprises a syringe 10 having a barrel 11 and a flange 12. A flange 12 is disposed 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 further comprises a finger grip 100. The grip is depicted in the fully engaged position. The grip engages the flange from its upper and lower surfaces 12-1 and 12-2. The grip portion also engages a portion of the outer surface of the barrel portion at the proximal end. The finger grip 100 is mounted around the piston 14 inserted into the barrel. During normal operation, the grip does not contact the piston. The piston is slidable within the barrel along its central longitudinal axis a. Advantageously, and as best seen in fig. 17, the grip may act as a stop, for example by means of a tab (tab) 50. The stop allows the piston rod 14r to pass through but restricts movement of the piston when engaged with the piston base 14 b.

The radially extending wings 101, 102 of the finger grip member provide the user with an extended surface area for gripping the device. As described in detail below, the grip may be provided in a variety of variants including variants that are tightly coupled to both the barrel and the flange, variants that are tightly coupled to the flange and loosely coupled to the barrel, variants that are tightly coupled to the barrel and loosely coupled to the flange, and variants that are slightly loosely coupled to both the flange and the barrel.

Fig. 2 to 21 provide detailed views of aspects related to embodiments of the injection device 1, the finger grip 10 and the coupling between the grip and the syringe, wherein fig. 11 to 15 describe in detail aspects of embodiments configured to achieve a tight coupling between the grip on the one hand and the barrel and flange on the other hand, and wherein fig. 16 to 21 show aspects having a loose coupling variant (flange or barrel) with the syringe. It will be appreciated that variants in which the coupling to both the barrel and the flange is relatively loose include corresponding aspects where appropriate.

As best seen in fig. 5, 8 and 10, for example, the grip 100 can be understood at least conceptually to include two interconnected portions including a base portion 104 providing a receptacle (berth) for receiving the flange 12 and a collar portion 103 providing a receptacle for receiving the barrel 11. The receptacles are fluidly connected to form a continuous chamber.

Fig. 5 provides a detailed side view of the device focused about the finger grip member 100 associated with the flange 12 and the proximal end 12p of the barrel 12 in a fully engaged position. Fig. 2 provides a cross-sectional bottom view of the injection device just below the collar, wherein the piston has been omitted in order not to hinder detailed viewing. Fig. 4 provides a corresponding top view. Fig. 3 provides a top view of the finger grip in an empty form (without the syringe inserted). Fig. 6 provides a view of the configuration shown in fig. 5 but without the syringe. Fig. 7 and 8 provide top and bottom perspective views of an empty grip. Fig. 9 and 10 provide side and cross-sectional side views, respectively, of the configuration shown in fig. 5.

As shown in fig. 6, the grip 100 includes a chamber 150 for receiving a syringe. The chamber may be understood as comprising a first portion 151 (receptacle) for receiving the flange 12 of the syringe and a second chamber portion 152 (receptacle) fluidly connected to the first portion and for receiving the barrel 11 along the terminal end 11p of the barrel. As shown, the first portion 151 of the chamber may be understood to be defined between 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 delimited by the inner surface 130 of the collar portion 103, which extends downwardly from the wall portion delimiting the first chamber portion in a direction along the central axis "a". The collar typically extends over a length of at least 2mm, typically in the range 2 to 10nm, for example in the range 3mm to 6mm, for example about 5mm. The longer the collar portion, the more stable the connection to the syringe will be. In order to minimize the effect on the gas flow resistance between the collar and the barrel, the overlap is preferably 10mm or less.

It will be appreciated that the grip advantageously provides an open structure to maximize the passage of gas to the syringe. To this end, the wall delimiting the chamber may be provided with one or more holes. As best seen in fig. 6-10, the chamber 151 may be understood to be laterally bounded by the opposing sidewalls 105, 106. These side portions are typically not engaged with the flange or any other portion of the syringe to minimize flush contact area. At least one of the side walls 105 includes a first aperture a1 sized to receive the flange from a lateral direction. The opposite side wall 106 may be provided with a second aperture a2, which is typically relatively smaller than the first aperture, to enable gas to pass through the chamber. The wall defining the top of the chamber 151 comprises a further hole a4 shaped to accommodate the passage of the piston rod. The collar is typically shaped/sized to partially wrap around the outer circumference of the barrel, with the aperture a3 sized to enable insertion of the barrel from a lateral direction.

Similar to the walls bounding 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. The holes a1 to a4 are shown in fig. 7,8 and 10. Fig. 3 and 7 also show the residual mark m formed by injection molding.

The grip portion includes a plurality of contact portions C1-1, C1-2, C1-3, C1-4, C2-1, C2-2, C2-3, C2-4, C2-5 for engagement with opposing points along the outer surface of the syringe. In each of the embodiments presented herein below, the first set of contacts C1 (for engagement with the flange) and the second set of contacts C2 (for engagement 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.

The contact line may be provided in a number of ways. In variations, such as best seen in fig. 11A, 11B, 12A, 12B, 13, 14, 15, and 16, the contact may be formed by one or more of a tangential contact between an outer surface of a flange or barrel of the syringe and one face (e.g., at a central portion thereof) of a multifaceted portion of an inner surface of the collar or base portion, a contact between an outer surface of a flange or barrel of the syringe and one of the vertices of a bend (or kink) of an inner surface of the collar or base portion, and/or an intersection or bend between two faces of a multifaceted portion of an inner surface of the collar or base portion by bending or bending.

As shown in fig. 13 to 15, the line contact may be achieved by portions 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. The angle is typically in the range 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 coupled to the grip, a substantially linear contact is formed. Angles within the specified range were found to provide adequate gas passages. In some embodiments, such as shown in fig. 14-15, the inner surface may be comprised of two or more sloped regions that meet at an intersection that provides a linear vertex. Note that the slopes in diagrams "i" and "ii" may be exaggerated for clarity.

Contact between the inner surface 130 of the collar 103 and the barrel 11 of the syringe is achieved in the absence of a protrusion. Bump-less contact may be achieved in a variety of ways.

For example, the linear contact may be provided by a receiving portion (chamber portion 152) for the barrel portion having a polygonal cross section. Instead of providing a protrusion, the inner surface of collar 103 may be configured to include a plurality of faces arranged at an angle relative to one another. Upon insertion of the barrel, some or each of the planar faces may make tangential contact with the barrel. The number of planes is more than or equal to 3. In one embodiment, as best seen in fig. 11A and 17B, the collar includes 5 flat faces 130-1,130-2,130-3,130-4,130-5 (see fig. 17), which are oriented to provide an object somewhat resembling a hexagonal barrel receiver that is open along one side. Because the barrel has a circular shape, the overall flush contact area is negligible.

In another or further variant, the cartridge receiver may be oblong (oblong). As best seen in fig. 12B, the inner surface 130 of the collar may be substantially smooth. When coupled with the syringe, the inner surface of collar 103 forms three tangential contacts c2-1, c2-2, c2-3 with barrel 11. The total contact area between the barrel and collar is negligible. Note the gas passage P between the barrel and collar.

It should be understood that the cartridge receiver should not be construed as limiting the depicted configuration, and that other polygonal or smoothly curved cross-sections (e.g., square, octagonal, oval, etc.) are contemplated.

Fig. 16 details a variation in which the grip portion is configured to provide loose contact with the barrel portion. In particular, the collar is slightly oversized with respect to the cross-sectional dimension of the cartridge to be received. In particular, the flat contact surfaces 130-1 to 130-5 are positioned such that at most three simultaneous contacts can be formed between the collar and the barrel. In fig. 16, the barrel is shown in an extreme position, in which two simultaneous contact lines c2-1, c2-2 are achieved. There is some space or play (slot) "s" along the opposite end.

Fig. 18 details another variation in which the grip is configured to provide loose contact with the barrel. In contrast to the variant shown in fig. 12A to 12B, the receptacle is oblong, so that only two simultaneous contacts with the barrel 11 can be achieved when fully coupled.

A slightly loose fit improves the gas path between the barrel and the finger grip. Typically, the play is. Gtoreq.1. Mu.m, for example. Gtoreq.5. Mu.m. Typically, the play is less than or equal to 300 μm, for example less than or equal to 200 μm, for example between 5 μm and 300 μm or between 1 μm and 200 μm. The inventors have found that within the specified range, the end user is substantially free from play during normal holding operations.

Of course, the grip portion may be configured such that the receiving portion matches the outer diameter of the barrel portion to be received (see fig. 11, 12 and 17), resulting in a total of five contact portions (respectively, three line contact portions) with the barrel portion 11.

Fig. 19, 20 and 21 detail aspects of a configuration in which the grip is sized to provide a looser coupling with the flange. Fig. 19 and 21A to 21C provide partial side views of an injection device 1 for administering a medicament. Fig. 20 shows the same grip but without the syringe.

As can be seen, the cavity portion 151 defined between the inner surfaces 110 and 120 for receiving the flange 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. Thus, there may be a space or play S between the upper surface 12-1 and the surface 110. The play improves the gas passage between the flange and the finger grip. Typically, the play is. Gtoreq.1. Mu.m, for example. Gtoreq.5. Mu.m. Typically, the play is 400 μm or less, 300 μm or less, for example 200 μm or less, for example between 5 μm and 300 μm or between 1 μm and 200 μm. The inventors have found that within the specified range, the end user is substantially unaware during normal holding operations.

Oversized barrel and/or flange receptacles advantageously accommodate conventional syringe manufacturing tolerances. The grip portion may advantageously be manufactured using conventional manufacturing methods including, but not limited to, molding (e.g., injection molding), even as a single component. Without wishing to be bound by theory, it is believed that simplifying manufacture is at least partially related to providing a smooth inner surface of the grip as disclosed herein. In particular, it is believed that the absence of outwardly extending protrusions (ribs, stakes, domes) aids in filling of the mold and release of the formed product from the mold.

The method includes forming a plastic compound, typically a thermoplastic compound, using a mold configured to define a base portion of a grip defining a first portion of a cavity of the grip for receiving a 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 the flange, and at least a first finger rest and a second finger rest extending laterally from the grip, wherein the mold is configured such that an inner surface of the base portion and an inner surface of the collar are formed such that a first set of first contacts and a second set of second contacts are provided, respectively, the inner surface of the base portion defines the first portion of the cavity, the inner surface of the collar defines the second portion of the cavity, the first set of first contacts is for engaging an outer surface of the flange, the second set of second contacts is for engaging an outer surface of the barrel, and wherein the mold is configured such that the inner surface of the collar and the inner surface of the grip are free of protrusions or extensions.

Advantageously, the disclosed injection device may be pre-filled with a drug, such as an ophthalmic drug.

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

The packaged injection device may be provided by a) providing a syringe comprising a barrel and a flange, b) filling the syringe with a medicament, if desired, c) providing a finger grip comprising a base portion defining a first portion of a cavity of the grip, the first portion being for receiving the flange, a collar portion defining a second portion of the cavity of the grip, the second portion being for receiving an end portion of the barrel adjacent 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 and an inner surface of the collar are formed such that a first set of first contacts and a second set of second contacts are provided, respectively, the inner surface of the base portion defines a first portion of the cavity, the first set of first contacts being for engaging an outer surface of the flange, the second set of second contacts being for engaging an outer surface of the barrel and wherein the base portion is adjacent the flange, and the outer surface of the syringe is free of the flange, and d) sealing the syringe to the syringe, and d) sealing the syringe to the package, and d) sealing the syringe to the syringe. Advantageously, sterilization may be performed after filling and/or after coupling. Optionally, sterilization or further sterilization may include exposure to a gaseous sterilant. Further, optionally, sterilization may be performed with the product already partially or fully disposed in the package.

For the purposes of clarity and conciseness of 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 or a combination of the described features. Of course, it is to be appreciated that any one of the above embodiments or processes may be combined with one or more other embodiments or processes to provide even further improvements in finding and matching designs and advantages.

In interpreting the appended claims, it should be understood that the word "comprising" does not exclude the presence of other elements or acts than those listed in a given claim, that the word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements, that any reference signs in the claims do not limit the scope of the claims, that a plurality of "means" may refer to the same or different items or implemented structures or functions, and that any of the disclosed devices or parts of the claims may be combined together or separated into additional parts, unless otherwise specifically stated. Where one claim refers to another claim, this may represent a synergistic advantage achieved by a combination of the features of each of these claims. The mere fact that certain measures are recited in mutually different claims does not indicate that a combination of these measures cannot be used to advantage. Thus, embodiments of the application may include all valid combinations of claims, where each claim may in principle refer to any preceding claim, unless the context clearly dictates otherwise.

Claims (18)

1. An injection device, the injection device comprising:

A syringe having a barrel and a flange, and

A finger-holding part, a finger-holding part and a finger-holding part, the finger grip is coupled to the syringe,

The finger grip includes:

i) A base portion defining a first portion of the cavity of the grip, the first portion receiving the flange,

Ii) a collar portion defining a second portion of the chamber of the grip, the second portion receiving an end portion of the barrel adjacent the flange, and

Wherein,

The inner surface of the base portion and the inner surface of the collar are formed to provide a first set of first and/or line contacts for engagement with the outer surface of the flange and a second set of second and/or line contacts for engagement with the outer surface of the barrel, respectively, wherein the inner surface of the base portion defines a first portion of the chamber and the inner surface of the collar defines a second portion of the chamber, 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 areas comprising at least the contacts comprised in the first and second sets.

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

3. The apparatus of claim 1 or 2, wherein the first contact and the second contact are constituted by line contacts.

4. A device according to any one of claims 1 to 3, wherein there is a close coupling between the flange and the grip of the syringe by the base portion being configured to provide simultaneous direct contact of each of the first contacts comprised in the first subset with the outer surface of the flange, and wherein there is a loose coupling between the barrel and the grip of the syringe by the collar portion being configured such that only a limited subset of the second contacts comprised in the second set can be simultaneously in direct contact with the barrel during normal operation.

5. A device according to any one of claims 1 to 3, wherein there is a close coupling between the barrel portion and the grip portion of the syringe by means of the collar portion, which collar portion is configured to provide simultaneous direct contact of each of the second contacts comprised in the second subset with the outer surface of the barrel portion, and wherein there is a loose coupling between the flange of the syringe and the grip portion by means of the base portion, which base portion is configured such that only a limited subset of the first contacts comprised in the first set can be simultaneously in direct contact with the flange during normal operation.

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

7. The apparatus of any one of the preceding claims, wherein the contact line is provided by one or more of:

A tangential contact between the outer surface of the flange or barrel of the syringe and one face of the multi-face portion of the inner surface of the collar portion or base portion, or

A contact between an outer surface of a flange or barrel of the syringe and one of an apex of a bend of the collar portion or an inner surface of the base portion that is bent or curved or an intersection between two faces of a multi-face portion of the collar portion or the inner surface of the base portion that is bent or curved.

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

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

10. The apparatus according to the preceding claim, wherein the number of second contact portions for engaging the barrel portion is 3.

11. The apparatus of any one of the preceding claims, wherein the grip portion further comprises a stop lug to limit release of a piston from the barrel portion.

12. The apparatus of any one of the preceding claims, wherein the grip is an integrally formed component.

13. The apparatus of any one of the preceding claims, wherein the syringe is filled with a drug.

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

15. A finger grip configured for coupling with a syringe comprising a barrel and a flange, preferably, the finger grip is according to any one of the preceding claims, comprising at least:

A base portion of the grip defining a first portion of the cavity of the grip for receiving the flange, and

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 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 and/or line contacts for engagement with the outer surface of the flange and a second set of second and/or line contacts for engagement with the outer surface of the barrel, respectively, the inner surface of the base portion defining a first portion of the chamber and the inner surface of the collar defining a second portion of the chamber, respectively, 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 comprising at least the contacts comprised in the first set of contacts and the second set of contacts.

16. A method of manufacturing a finger grip configured for coupling with a syringe comprising a barrel and a flange includes forming a plastic composite using a mold configured to define:

A base portion of the grip defining a first portion of the cavity of the grip for receiving the flange, and

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 the flange,

Wherein the mould is configured such that the inner surface of the base portion and the inner surface of the collar are formed to provide a first set of first and/or line contacts for engagement with the outer surface of the flange and a second set of second and/or line contacts for engagement with the outer surface of the barrel, respectively, the inner surface of the base portion defining a first portion of the chamber and the inner surface of the collar defining a second portion of the chamber, respectively, and

Wherein the mould is configured such 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 free of outwardly extending protrusions for contacting portions of the syringe in an area comprising at least the contacts comprised in the first set of contacts and the second set of contacts.

17. A method of manufacturing a packaged injection device, preferably a packaged injection device according to claim 14, the method comprising:

a) Providing a syringe comprising a barrel and a flange;

b) Filling the syringe with a drug;

c) And a collar portion defining a second portion of the cavity of the grip portion for receiving an end portion of the barrel portion adjacent 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 and/or line contacts and a second set of second and/or line contacts, respectively, the inner surface of the base portion defining a first portion of the cavity, the inner surface of the collar defining a second portion of the cavity, the first set of first and/or line contacts for engaging an outer surface of the flange, the second set of second and/or line contacts for engaging an outer surface of the barrel portion, and wherein the inner surface of the base portion of the grip portion and the inner surface of the base portion are free of contact in at least a smooth region of the contact between the inner surface of the base portion and the outer surface of the grip portion;

d) Coupling the finger grip to the syringe, forming 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 performed after the filling and the coupling.

18. Method according to the preceding claim, wherein further sterilization comprising exposure to a gaseous sterilant or said sterilization e) is carried out after e).