Adapter for drug delivery device and drug delivery device

Abstract

The present invention relates to an adapter (30) for a drug delivery device, the drug delivery device having a reservoir (12) and a longitudinal tip (20). The adapter (30) comprises a proximal portion and a distal portion, the proximal portion defining a connection ring (31) for receiving a connector, the distal portion defining a mounting ring (33) having an inner surface (34). The mounting ring (33) is shaped and configured to form at least one annular space (38) between the inner surface (34) of the mounting ring (33) and the outer surface (20a) of the longitudinal tip (20) when the adapter (30) is assembled around the longitudinal tip (20) of the drug delivery device. The at least one annular space (38) can accommodate an adhesive layer (40) so as to bond the adapter (30) to the longitudinal tip. The present invention also relates to a drug delivery device comprising the adapter.

Description

[0001] Description of the case

[0002] This invention patent application is a divisional patent application.

[0003] The original application of this divisional patent application is an invention patent application with an application date of June 12, 2016, application number 201610637583.8, and invention name “Adapter for drug delivery device and drug delivery device”. Technical Field

[0004] The present invention relates to an adapter, in particular a Luer lock adapter, for a drug delivery device having a reservoir and a longitudinal tip, the adapter being wrapped around the longitudinal tip of the drug delivery device to connect the drug delivery device to a connector (e.g. an injection needle or an intravenous line), and a drug delivery device comprising such an adapter. Background Art

[0005] In the present application, the distal end of a component or device must be understood to mean the end farthest from the user's hand, and the proximal end must be understood to mean the end closest to the user's hand, which also applies to a drug delivery device used with the component or device. Similarly, in the present application, the distal direction must be understood to mean the direction of injection with a drug delivery device, while the proximal direction is the direction opposite to the injection direction.

[0006] Drug delivery devices are widely used by medical staff and patients to store and / or manage and / or transfer drug ingredients, such as drugs, vaccines, cosmetics or diagnostic liquids. The drug delivery device can be in the form of a box or a syringe, both of which contain a reservoir for storing drug ingredients. The drug delivery device is preferably made of glass because glass has high chemical inertness, low permeability and high transparency, which can allow for extended storage and easy inspection. The drug delivery device, such as a syringe, has a longitudinal tip at its distal end (the end of the injection direction, close to the patient's skin), and the longitudinal tip has a longitudinal channel for distributing the drug stored in the reservoir. However, this longitudinal tip does not allow parenteral administration by itself, and must include a push needle or adapter to allow the syringe to be connected to a connector, which can be a needle hub or an intravenous (IV) tube. The adapter is a key part of injection safety, and it must be reversibly connected to the connector and irreversibly fixed to the longitudinal tip of the syringe. Of course, it is important to accurately and safely assemble the adapter and connector together on the longitudinal tip of the syringe to ensure safety.

[0007] The connection between the adapter and the connector is usually achieved by two cooperating threads, one on the inside of the adapter and the other on the outside of the proximal end of the connector, so that the needle or intravenous line can be screwed into the adapter before injection. However, such a two-part threaded connection often results in significant pull-out forces between the tip and the adapter, as the connector exerts pressure on the tip and creates a back pressure on the adapter to create a tight seal. In addition, when viscous drugs are injected, pull-out forces acting on the adapter are generated because the inner diameter of the connector is smaller than the diameter of the longitudinal passage of the tip. Both phenomena can cause the adapter to detach from the drug delivery device, which may affect the safety of patients and medical personnel.

[0008] Finally, the secure threaded connection of the connector often results in a significant torque acting on the connector, which is transmitted to the adapter; resulting in the risk of the adapter end rotating around the longitudinal tip. This may prevent a secure connection between the connector and the adapter, as it is difficult to ensure that the connector is fully screwed into the adapter. As a result, the connection between the adapter and the longitudinal tip of the syringe must resist the withdrawal forces and torques generated during the connection of the connector and / or during the injection. In fact, the detachment of the adapter from the tip of the syringe may lead to the leakage of expensive drugs and the occurrence of inaccurate injections, or, in extreme cases, the ejection of drugs or the ejection of injection needles. In addition, the rotation between the adapter and the longitudinal tip may prevent the ideal connection with the connector and may therefore cause drug leakage and / or injection needle stick injuries as described above.

[0009] Adapters for connecting drug delivery devices to connectors are known. These adapters are often securely mounted around the longitudinal tip of the syringe by means of a bayonet fit or friction, for example by mounting the adapter to the longitudinal tip by means of a mechanical connection such as a groove or ring. However, the means for coupling on the longitudinal tip require complex molding tools in the case of a plastic drug delivery device or additional molding steps in the case of a glass drug delivery device, which are difficult to control. In addition, the modified longitudinal tip is sensitive to cracks, which may lead to tip breakage. Last but not least, adapters that are mounted around the longitudinal tip by means of a bayonet fit or friction often show limited torque resistance.

[0010] Therefore, there is a need for an adapter that has an ideal resistance to both extraction force and torque. There is also a need for an adapter that can be mounted on a regular longitudinal tip without any additional connection means. Finally, there is also a need for a drug delivery device that cooperates with the adapter. These needs are achieved by various embodiments of the present application. Summary of the invention

[0011] One embodiment of the present invention is an adapter for a drug delivery device having a reservoir and a longitudinal tip having an outer surface and a longitudinal passage for delivering any drug stored in the reservoir. The adapter has a distal portion defining a connection ring for receiving a connector, and a proximal portion defining a mounting ring having an inner surface. The mounting ring is shaped and configured so that when the adapter is assembled around the longitudinal tip of the drug delivery device, an annular space is formed between the inner surface of the mounting ring and the outer surface of the longitudinal tip, the annular space can accommodate an adhesive layer, the adhesive layer being used to bond the adapter to the longitudinal tip. The annular space is located at the distal end of the inner surface of the mounting ring.

[0012] The adhesive layer introduced between the adapter and the longitudinal tip makes it possible to prevent any torque or extraction forces from being transmitted to the adapter during use, thanks to the presence of an annular space, which is partially delimited by the annular ring. Furthermore, the adapter can be irreversibly coupled to a regular longitudinal tip without any connection means such as grooves or rings.

[0013] Particularly, in the adapter of the present invention, the radius of the inner diameter of the assembly ring is R1, the radius of the inner diameter of the annular ring is R2, and R1 is greater than R2.

[0014] One aspect of the present invention is an adapter for a drug delivery device, the drug delivery device having a reservoir and a longitudinal tip, the longitudinal tip having an outer surface and a longitudinal channel for delivering any drug stored in the reservoir, the adapter having a distal portion defining a connecting ring for receiving a connector, and a proximal portion defining a mounting ring for connecting to the outer surface of the longitudinal tip, the mounting ring having an inner surface, wherein an annular ring is provided at the distal end of the inner surface of the mounting ring, wherein the radius of the inner diameter of the mounting ring is R1, the radius of the inner diameter of the annular ring is R2, and R1 is greater than R2.

[0015] The inner surface of the mounting ring and the proximal wall of the annular ring define an inner annular groove of the mounting ring, the inner annular groove is open at its proximal end and closed by the proximal wall of the annular ring at its distal end. The radius R3 of the inner annular groove is equal to R1-R2.

[0016] When the adapter of the present invention is mounted around the longitudinal tip of the drug delivery device, the inner annular groove forms an annular space between the inner surface of the mounting ring and the outer surface of the longitudinal tip. As will be seen below, the annular space can be used to accommodate an adhesive layer that enables the adapter to be bonded to the longitudinal tip. In some embodiments, the inner surface of the mounting ring includes at least one protrusion, so that when the adapter is mounted around the longitudinal tip of the drug delivery device, the at least one protrusion extends into the at least one annular space.

[0017] In a preferred embodiment, the inner surface of the mounting ring includes a plurality of protrusions, so that when the adapter is mounted around the longitudinal tip of the drug delivery device, the plurality of protrusions extend into the annular space formed between the mounting ring and the longitudinal tip. The plurality of protrusions may or may not be in contact with the outer surface of the longitudinal tip, and the protrusions may be used to optimize the annular space, in particular when the annular space accommodates an adhesive layer. Specifically, the protrusions are used to optimize the internal structure of the inner annular groove and the internal structure of the annular space, by forming a plurality of partially separated spaces in the inner annular groove and the annular space, the partially separated spaces being connected to each other and each space being able to receive a portion of the adhesive to form an adhesive layer.

[0018] In some embodiments, the at least one protrusion is selected from the following options: at least one continuous longitudinal rib, at least one segmented rib, several transverse segments, at least one diagonal rib, a spherical body or a cylindrical body, a T-shaped body or a cross-shaped body. These protrusions can be composed of many shapes, such as: continuous longitudinal ribs or segmented longitudinal ribs, transverse segments, diagonal ribs, spherical bodies or cross-shaped bodies, and at least one protrusion meets the requirements. These protrusions separate some spaces, which are connected to each other, so that when the fluid adhesive is introduced into the annular space through the proximal opening end of the inner annular groove, the adhesive fills the multiple spaces formed in the inner annular groove by flowing and dispersing. When the adhesive layer is introduced into the annular space, the continuous or segmented longitudinal ribs form additional resistance to the torque acting on the adapter, and the transverse ribs form additional resistance to the pull-out force acting on the adapter. The diagonal ribs, spherical bodies and / or cross-shaped bodies form additional resistance to both torque and pull-out force.

[0019] In some embodiments, the inner surface of the mounting ring includes protrusions in the form of longitudinal ribs. For example, the inner surface of the mounting ring includes protrusions in the form of three longitudinal ribs, which protrude from the inner surface of the mounting ring. The longitudinal ribs can be regularly distributed on the circumference of the inner surface. The longitudinal ribs can extend over the entire length of the mounting ring. In some embodiments, the longitudinal ribs are continuous longitudinal ribs. In some embodiments, the longitudinal ribs are segmented longitudinal ribs. When the adapter is assembled to the longitudinal tip of the drug delivery device, the continuous or segmented longitudinal ribs can form additional resistance to the torque acting on the adapter.

[0020] In some embodiments, the inner surface of the mounting ring comprises protrusions in the form of transverse segments. The transverse segments may provide additional resistance to extraction forces acting on the adapter when the adapter is mounted to the longitudinal tip of the drug delivery device.

[0021] In some embodiments, the inner surface of the mounting ring includes protrusions in the form of three diagonal ribs. In some embodiments, the inner surface of the mounting ring includes protrusions in the form of a spherical body or a cylindrical body. In some embodiments, the inner surface of the mounting ring includes protrusions in the form of a T-shaped body or a cross-shaped body.

[0022] The annular ring is used to prevent the adhesive from reaching the distal region of the longitudinal tip, so that it remains clean during future medical use. In addition, the annular ring can help as a centering device during the assembly of the adapter described in the present invention to the longitudinal tip of the drug delivery device.

[0023] In some embodiments, R1 is the radius of the inner diameter of the mounting ring, R2 is the radius of the inner diameter of the annular ring, R1 is greater than R2, the inner surface of the mounting ring and the proximal wall of the annular ring form an internal annular groove on the mounting ring, the internal annular groove is open at its proximal end and closed at its distal end by the proximal wall of the annular ring, the radius R3 of the internal annular groove is equal to R1-R2, and the range of R3 is 0.3-0.5mm.

[0024] In some embodiments, the inner surface of the mounting ring includes a protrusion that projects into the inner annular groove of the mounting ring.

[0025] To ensure ideal mechanical properties, the adapter is preferably made of a single piece of material. For the same reasons, hard plastic can be a material choice. Optionally, the adapter can be made of a light-transmitting material to allow inspection of leaks and / or connection defects when the connector is connected to the adapter.

[0026] Another embodiment of the present invention is a drug delivery device, which includes a reservoir for storing the drug to be dispensed and a longitudinal tip having a longitudinal channel for dispensing any drug stored in the reservoir. The drug delivery device also includes an adapter mounted around the longitudinal tip to enable a connector to be connected to the longitudinal channel, the adapter being bonded to the longitudinal tip by an adhesive layer. The adhesive layer brings important improvements compared to the prior art. In particular, the adhesive layer forms a high resistance to torque and extraction forces acting on the adapter. In addition, the adapter can be irreversibly assembled to the longitudinal tip of the drug delivery device without the aid of any other connecting means. This avoids additional manufacturing steps for manufacturing the connecting means and prevents weakening of the longitudinal tip, particularly when the drug delivery device is made of glass.

[0027] When the inner surface of the adapter mounting ring includes protrusions, the protrusions can enhance the adhesion of the adhesive layer, resulting in a higher resistance to pull-out forces and / or torque. The protrusions can also improve the uniformity of the adhesive layer.

[0028] Before use, the drug delivery device with the adapter as described in the present invention is closed by the end cap to prevent the drug stored in the reservoir from leaking during storage and transportation. Some examples of the end cap are described in the international application WO2015055608 and the European application EP1192965. Preferably, the drug delivery device closed with the end cap can have a mark used in the prior art so that it can be seen whether the drug delivery device has been opened, which is unsafe for injection if opened. The marks used in the prior art include a shrinkable film as disclosed in the international application WO2010064074, or a fragile label between the adapter and the end cap.

[0029] The adapter, which is mounted on the longitudinal tip of the drug delivery device, exhibits a high resistance to torque or extraction forces generated during handling and / or use.

[0030] Further advantageous embodiments of the invention are described below. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 A drug delivery device according to the present invention is shown.

[0032] Figure 2 yes Figure 1 Magnified image of the longitudinal tip of the drug delivery device.

[0033] Figure 3 A cross-sectional view of an adapter according to an embodiment of the present invention is shown.

[0034] Figure 4 Shows Figure 3 Rear view of the adapter in the .

[0035] Figure 5 Shows Figure 3 Stereoscopic rear view of the adapter in FIG.

[0036] Figure 6 yes Figure 3 A cross-sectional view of the adapter in FIG. 1 when assembled on the longitudinal tip of the drug delivery device.

[0037] Figure 7 yes Figure 6 A cross-sectional view of the adapter along surface II'.

[0038] Figures 8A to 8C yes Figure 3 The adapter in the Figure 2 Cross-sectional views of different embodiments of the longitudinal tip of a drug delivery device.

[0039] Fig. 9 yes Figure 3 Cross-sectional view of an adapter bonded to the longitudinal tip of a drug delivery device.

[0040] Fig.10 yes Fig. 9 Cross-sectional view of the adapter along surface II-II'.

[0041] Figures 11A-11F It is a plane projection of the inner surface of the mounting ring of the adapter of different embodiments of the adapter in the present invention. DETAILED DESCRIPTION

[0042] Figure 1 An embodiment of a drug delivery device 10 of the present invention is disclosed. The drug delivery device 10 has a longitudinal axis A and includes a reservoir 12 formed by a longitudinal barrel 11, the longitudinal barrel 11 having an open proximal end, the proximal end defining a flange 13, and a restricted distal end, the distal end defining a longitudinal tip 20, the latter having a longitudinal channel 21. The boundary between the longitudinal tip 20 and the barrel 11 defines a shoulder 14. An adapter 130 having a longitudinal axis B and an annular ring 136 is assembled around the longitudinal tip 20, so that an annular space 138 is formed between the adapter 130 and the longitudinal tip 20. In addition, an adhesive layer 40 is introduced into the annular space 138 to bond the adapter 130 to the longitudinal tip 20. As shown in FIG. Figure 1 As shown, when the adapter 130 is bonded to the longitudinal tip 20 , the longitudinal axis B of the adapter 130 is aligned with the longitudinal axis A of the drug delivery device 10 .

[0043] like Figure 2As shown, the longitudinal tip 20 of the drug delivery device 10 has an outer surface 20a and is generally conical. More specifically, the longitudinal tip 20 includes a cylindrical portion 22, which is located proximal to the conical portion 23. The longitudinal tip 20 defines a distal surface 24, which can be a flat surface, an inclined surface, or a curved surface. In another embodiment (such as Figure 8C As shown in FIG. 2 , the longitudinal tip 20 includes only the conical portion 23 but not the cylindrical portion 22.

[0044] Figures 3 to 5 A first embodiment of the adapter 130 of the present invention is disclosed.

[0045] The adapter 130 includes a distal portion 130a defining a connection ring 131 having an inner surface 132. The inner surface 132 is provided with threads 132a, which serve as connection components for connecting to a connector (not shown), such as a needle or an intravenous line. Alternatively, these connection components may be a snap-on system or a capture system (not shown). The distal end of the connection ring 131 defines a distal end 130c of the adapter 130.

[0046] The adapter 130 also includes a proximal portion 130b having a mounting ring 133 defining an inner surface 134. The inner surface 134 of the mounting ring 133 of the adapter 130 has protrusions in the form of three longitudinal ribs 135 that protrude from the inner surface 134 of the mounting ring 133 ( Figure 3 Only one can be seen in the figure). Preferably, each longitudinal rib 135 is regularly distributed on the circumference of the inner surface 134. Preferably, each longitudinal rib 135 extends over the entire length of the mounting ring 133. In this embodiment, each longitudinal rib 135 is a continuous longitudinal rib.

[0047] In addition, an annular ring 136 is defined at the distal end of the inner surface 134, and the annular ring 136 is located at the junction between the assembly ring 133 and the connecting ring 131. Figures 3 to 5 In some embodiments, the annular ring 136 is in contact with each longitudinal rib 135, but in other embodiments, each longitudinal rib 135 is adjacently spaced apart from the annular ring 136.

[0048] See also Figure 3 , which shows the radius R1 of the inner diameter of the mounting ring 133 and the radius R2 of the inner diameter of the annular ring 136. As can be seen from the figure, R1 is greater than R2.

[0049] like Figure 3-5As shown, the inner surface 134 of the mounting ring 133 and the proximal wall 136a of the annular ring 136 define an inner annular groove 140 of the mounting ring 133, which is open at the proximal end and closed at the distal end by the proximal wall 136a of the annular ring 136. The inner annular groove 140 has a radius R3, which is equal to R1-R2.

[0050] In some embodiments, R3 is in the range of 0.3-0.5 mm.

[0051] like Figure 3-5 As shown, the longitudinal ribs 135 extend into the inner annular groove 140 .

[0052] The adapter 130 may have a raised design on its outer surface, for example a longitudinal protrusion 137 of more or less certain thickness (see Figure 5 ), for example, to facilitate holding. Figure 5 The longitudinal protrusion 137 shown in the figure provided on the outer surface of the adapter is an embodiment of the protrusion design. When the connector is to be screwed into the drug delivery device of the present invention, the protrusion design can facilitate the user to conveniently control the adapter 130 even if the user is wearing gloves or has wet hands.

[0053] The adapter 130 can be made of any hard polymer suitable for medical use, such as high-density polyethylene (PE), polypropylene (PP), polycarbonate (PC), acrylonitrile-styrene-butadiene copolymer (ABS), polyoxymethylene (POM), polystyrene (PS), polybutylene terephthalate (PBT), polyamide (PA) and combinations thereof. To simplify the process, the adapter 130 is preferably made of a single piece of material, preferably a light-transmitting material.

[0054] The adapter 130 is used to be assembled on the longitudinal tip 20 of the drug delivery device 10, so that the distal surface 24 of the drug delivery device 10 extends out of the connecting ring 131 in the distal direction, and the distance of the extension is P ( Figure 6 and Fig. 9 As shown in Figure 6 , 7 As shown in FIGS. 8A-8C , the mounting ring 133 is shaped and assembled to form an annular space 138 between the inner surface 134 of the mounting ring 133 and the outer surface 20a of the longitudinal tip 20. The annular space 138 can accommodate the adhesive layer 40 to facilitate the irreversible bonding of the adapter 130 to the longitudinal tip 20. In particular, the inner annular groove 140 of the mounting ring 133 allows the annular space 138 to be created.

[0055] exist Fig. 8AIn the embodiment, the mounting ring 33 is mounted on the cylindrical portion 22 of the tip 20, and the conical portion 23 of the conical tip can be used for any connection. The longitudinal ribs 135 and the annular ring 136 may or may not be in contact with the outer surface 20a of the longitudinal tip 20. Preferably, at least one of the longitudinal ribs 135 or the annular ring 136 is in contact with the outer surface 20a of the longitudinal tip 20. If desired, at least one of the longitudinal ribs 135 or the annular ring 136 is interference fit with the outer surface 20a of the longitudinal tip 20. For example Figure 6 As shown, the interference fit between the annular ring 136 and the outer surface 20a of the longitudinal tip 20 is Figure 6 and Figure 7 The interference fit is advantageous for pre-assembling the adapter 130 to the longitudinal tip 20 by friction before irreversibly bonding with the adhesive layer 40. Figure 7 As shown, it can be seen that there is an overlap OV between the longitudinal rib 135 and the outer surface 20a of the longitudinal tip 20, which also helps to generate friction during the pre-assembly process. Figure 7 As shown, each longitudinal rib 135 divides the inner annular groove 140, so that the longitudinal rib 135 divides the annular space 138 into three cavities (138a, 138b, 138c), each of which is open at its proximal end, and each cavity is closed by two longitudinal ribs 135 and a portion of the annular ring 136.

[0056] Optionally, the mounting ring 133 of the adapter 130 may be mounted on the cylindrical portion 22 and the conical portion 23 of the longitudinal tip 20. Figure 8B As shown, the longitudinal ribs 135 face the cylindrical portion 22 or are in contact with the cylindrical portion 22, while the annular ring 136 faces the conical portion 23 or is in contact with the conical portion 23 of the longitudinal tip 20. Figure 8B In the embodiment, the annular ring 136 and the longitudinal ribs 135 do not contact each other and are separated by the void space VS. Such a structure helps to expand the area of ​​the annular space 138, and the annular space 138 is used to accommodate the adhesive layer 40. In other words, Fig. 8A Compared with the embodiment of FIG. 1 , by such a structure, the adhesive layer 40 having a larger area is accommodated between the outer surface 20a of the longitudinal tip 20 and the inner surface 134 of the mounting ring 133. Preferably, as Fig. 8A and 8B As shown, the inner surface 134 of the mounting ring 133 is substantially parallel to the outer surface 20a of the longitudinal tip 20, which results in an annular space 138 having a constant thickness (t). In these embodiments, the inner surface 134 of the mounting ring 133 is substantially parallel to the outer surface 20a of the longitudinal tip 20, and the annular space 138 has a constant thickness (t), and the volume of the annular space 138 is substantially equal to the volume of the inner annular groove 140.

[0057] In such Figure 8C In another embodiment shown, the longitudinal tip 20 does not have a cylindrical portion 22, but only a conical portion 23. In this embodiment, the inner surface 134 of the mounting ring 133 has a straight profile, while the outer surface 20a of the longitudinal tip 20 has an inclined profile, which results in the annular space 138 having a gradual thickness (t ’ In this embodiment, the volume of the annular space 138 may be significantly smaller than the volume of the inner annular groove 140 of the mounting ring 133 .

[0058] For example, to bond the adapter 130 to the longitudinal tip 20, adhesive is introduced into the annular space 138. Due to the longitudinal ribs 135, the adhesive is evenly distributed in the annular space 138 to form a uniform adhesive layer 40 (eg, Fig. 9 and Fig.10 ), the adhesive layers 40 are separated by the longitudinal ribs 135. The annular ring 136 acts as a barrier for the adhesive to prevent the adhesive from reaching the distal portion of the longitudinal tip 20, which is thus kept clean for future medical use. The adhesive can be dispensed onto the adapter 130 before or after the adapter is placed around the longitudinal tip 20.

[0059] The adhesive may be any material suitable for bonding parts in the medical field. Preferably, the adhesive may be selected from hot melt adhesives and glues, such as acrylic glues. The area of ​​the bonding area is between 20 and 40 mm 2 and the thickness of the adhesive layer 40 is between 0.3 and 0.5 mm.

[0060] The adhesive may be cured in any manner to form adhesive layer 40 ( Figure 9-10 134 ), the adhesive layer 40 is permanently bonded to the outer surface 20a of the longitudinal tip 20 and the inner surface 134 of the adapter 130. The curing method can be selected according to the method used for the specific adhesive, and can be selected from gamma ray irradiation, ultraviolet irradiation, heating, cooling or drying and the like. Prior to the curing step, the interference fit between the outer surface 20a of the longitudinal tip 20 and the annular ring 136 and / or the longitudinal ribs 135 helps to temporarily install the adapter 130 to the correct position of the longitudinal tip 120, thereby avoiding any wrong connection caused by vibration during the assembly process.

[0061] At the end of the assembly process, Fig. 9 and Fig.10As shown, the adapter 130 is irreversibly bonded to the longitudinal tip 120 of the drug delivery device 110 by means of an adhesive layer 40 contained in an annular space 138. Due to the adhesive layer 40, the adapter 130 is bonded around the longitudinal tip 20 without any grooves or rings on the outer surface 20a of the longitudinal tip 20, which are often required on the adapter in the prior art. This greatly simplifies the manufacturing process of the drug delivery device, especially when the drug delivery device is made of glass. In addition, the chemical bonding provided by the adhesive layer 40 allows for a large damping of torque and pull-out forces, which often act on the adapter 130 when the connector is connected to the connecting ring 131 of the adapter 130.

[0062] like Fig.10 As shown, the adhesive layer 40 is divided into three parts (40a, 40b, 40c) by respective longitudinal ribs 135, which helps to resist the significant torque applied when the connector is connected to the drug delivery device 10 through the adapter 130. When such torque is applied, the longitudinal ribs 135 can reduce the shear force acting between the adhesive and the outer surface 20a of the longitudinal tip 120 or between the adhesive and the inner surface 134 of the mounting ring 133 of the adapter 130. The longitudinal ribs 135 act as mechanical stops by hindering potential rotational movement between the adapter 130 and the adhesive layer 40, which helps to increase the torque damping of the adapter 130 being bonded to the longitudinal tip 20 of the drug delivery device 10 through the adhesive layer 40.

[0063] In other embodiments, the protrusions may have other shapes to achieve different technical effects. Fig.11A The first embodiment of the present invention ( Figure 3-5 ) is a planar projection of the inner surface 134 of the mounting ring 133 of the adapter 130 and is provided as a reference.

[0064] Fig. 11B FIG. 2 shows a planar projection of an inner surface 234 of a mounting ring 233 of an adapter 230 according to another embodiment of the present invention. The adapter 230 is similar to the adapter 130 described above, except that the inner surface 234 includes protrusions in the form of segmented longitudinal ribs 235. The protrusions 235 help optimize the uniformity of the adhesive layer 40 in the second step of the assembly process described above. Fig. 11B As shown, an annular ring 236 is located at the distal end of the inner surface 234 of the mounting ring 233 .

[0065] Fig. 11CA plan projection of an inner surface 334 of a mounting ring 333 of an adapter 330 of another embodiment of the present invention is shown. The adapter 330 is similar to the adapter 130 described above, except that the inner surface 334 includes a protrusion in the form of a transverse segment 335. For example, when the connector is connected to the connecting ring 331 and the adapter 330 is subjected to a pull-out force, the protrusion 335 helps to reduce the shear force acting between the adhesive and the inner surface 334 or between the adhesive and the outer surface 20a of the longitudinal tip 20. When the adapter 330 is assembled to the longitudinal tip 20 of the drug delivery device 10 through the adhesive layer 40, the transverse segment 335 acts as a mechanical stop by hindering the potential pull-out movement between the adapter 330 and the adhesive layer 40, which helps to increase the pull-out damping on the adapter 330. As shown in FIG. Fig. 11C As shown, an annular ring 336 is located at the distal end of the inner surface 334 of the mounting ring 333 .

[0066] Fig.11D A plan projection of an inner surface 434 of a mounting ring 433 of an adapter 430 of another embodiment of the present invention is shown. The adapter 430 is similar to the adapter 130 described above, except that the inner surface 434 includes protrusions in the form of three diagonal ribs 435, at least one of which is required. Due to their diagonal positioning, the protrusions 435 help to provide a mechanical stop by hindering withdrawal movements and torque when the adapter 430 is bonded to the longitudinal tip 20 of the drug delivery device 10 via the adhesive layer 40. The protrusions 435 help to obtain a uniform adhesive layer 40, for example by rotating the adapter 430 during the introduction of the adhesive in the second step of the assembly process described above. As shown in FIG. Fig.11D As shown, an annular ring 436 is located at the distal end of the inner surface 434 of the mounting ring 433.

[0067] Fig.11E A plan projection of the inner surface 534 of the mounting ring 533 of an adapter 530 according to another embodiment of the present invention is shown. The adapter 530 is similar to the adapter 130 described above, except that the inner surface 534 includes protrusions in the form of spherical or cylindrical bodies 535. Similar to the diagonal ribs 435, the spherical bodies 535 help provide a mechanical stop by hindering the withdrawal movement and torque when the adapter 530 is bonded to the longitudinal tip 20 of the drug delivery device 10 via the adhesive layer 40. The protrusions 535 help to obtain a uniform adhesive layer 40, for example, by dispersing the adhesive in the annular space 438 by filtration in the second step of the process described above. As shown in FIG. Fig.11E As shown, an annular ring 536 is located at the distal end of the inner surface 534 of the mounting ring 533.

[0068] Fig.11FFIG. 6 is a planar projection of an inner surface 634 of a mounting ring 633 of an adapter 630 according to another embodiment of the present invention. The adapter 630 is similar to the adapter 130 described above, except that the inner surface 634 includes a protrusion formed by a T-shaped body or a cross-shaped body 635. Similar to the diagonal ribs 435 and the spherical body 535, the cross-shaped body 635 helps to provide a mechanical stop by hindering the withdrawal motion and torque when the adapter 630 is bonded to the longitudinal tip 20 of the drug delivery device 10 via the adhesive layer 40. Fig.11F As shown, an annular ring 636 is located at the distal end of the inner surface 634 of the mounting ring 633.

[0069] exist Figures 11B to 11F In the illustrated embodiment, when the corresponding adapter (230, 330, 430, 530, 630) is coupled to the longitudinal tip 20 of the drug delivery device 10, the protrusions (235, 335, 435, 535, 635) extend into the respective annular spaces formed between the inner surfaces (234, 334, 434, 534, 634) and the outer surfaces of the longitudinal ends, and are in contact or non-contact with the outer surface 20a of the longitudinal tip 20. In addition, the annular ribs in these embodiments are similar to the annular ribs 136 in the adapter 130. Where applicable, all individual technical features shown in the various embodiments may be combined and / or replaced without departing from the scope of the present invention.

[0070] Thus, the annular space formed between the outer surface 20a of the mounting ring of the adapter and the longitudinal tip 20 can be optimized by providing additional resistance to the pull-out force and / or torque to the adhesive layer through the protrusions. In addition, some protrusions can also help to improve the uniformity of the adhesive layer 40 to avoid defects in the adhesive layer 40.

[0071] In addition, due to the adapter mentioned in the previous embodiments, the longitudinal tip 20 of the drug delivery device 10 does not require additional connection components (e.g., annular grooves or rings), which are difficult to manufacture, especially when the drug delivery device is made of glass. Finally, since the glass forming process may lead to serious dimensional deviations, especially in the shoulder 14 between the longitudinal barrel 11 and the longitudinal tip 20, it is particularly valuable to combine the adapter exclusively around the longitudinal tip 20 without any direct contact with the longitudinal barrel 11 of the drug delivery device 10.

Claims

1. An adapter (130, 230) for a drug delivery device (10), the drug delivery device (10) having a reservoir (12) and a longitudinal tip (20); The tip (20) has an outer surface (20a) and a longitudinal passage (21) for dispensing any substance stored in the reservoir (12); The adapter (130, 230) comprises a distal portion (130a, 230a) and a proximal portion (130b, 230b), the distal portion defining a connection ring (131) for receiving a connector, and the proximal portion defining a mounting ring (133, 233) having an inner surface (134, 234); The mounting ring (133, 233) is shaped and configured such that: when the adapter (130, 230) is mounted around the longitudinal tip (20) of the drug delivery device (10), at least one annular space (138) is formed between the inner surface (134, 234) of the mounting ring (133, 233) and the outer surface (20a) of the longitudinal tip (20); the at least one annular space is capable of accommodating an adhesive layer (40) so as to bond the adapter (130, 230) to the longitudinal tip (20); in, An annular ring (136, 236) is provided at the distal end of the inner surface (134, 234) of the assembly ring; wherein the inner surface (134, 234) of the mounting ring (133, 233) comprises at least one protrusion (135, 235), such that when the adapter (130, 230) is assembled around the longitudinal tip (20) of the drug delivery device (10), the at least one protrusion (135, 235) extends into the at least one annular space (138), the protrusion being in the form of a longitudinal rib; Wherein, the longitudinal ribs are continuous longitudinal ribs (135) or segmented longitudinal ribs (235); Wherein, R1 is the radius of the inner diameter of the mounting ring, R2 is the radius of the inner diameter of the annular ring, R1 is greater than R2, the inner surface of the mounting ring and the proximal wall of the annular ring define an inner annular groove of the mounting ring, the inner annular groove is open at its proximal end and its distal end is closed by the proximal wall of the annular ring, and the radius R3 of the inner annular groove is equal to R1-R2, wherein the range of R3 is 0.3-0.5 mm; and The inner surface (134, 234) of the mounting ring (133, 233) comprises protrusions in the form of three longitudinal ribs (135, 235) protruding from the inner surface (134, 234) of the mounting ring (133, 233).

2. The adapter (130, 230) of claim 1, wherein: The longitudinal ribs (135, 235) are regularly distributed on the circumference of the inner surface (134, 234).

3. A drug delivery device (10), comprising an adapter (130, 230) according to any one of the preceding claims.

4. The drug delivery device (10) according to claim 3, wherein: The adapter (130, 230) is irreversibly bonded to the longitudinal tip (20) by an adhesive layer (40) contained in the annular space (138).

5. The drug delivery device (10) according to claim 4, wherein: The thickness of the adhesive layer (40) is at least 0.3 mm.

6. The drug delivery device (10) according to claim 4, wherein: The adhesive layer (40) covers an area of ​​at least 20 mm on the outer surface (20a). 2 .

7. The drug delivery device of claim 4, wherein: The at least one protrusion (135, 235) extends into the adhesive layer (40).

8. A drug delivery device according to any one of claims 3 to 7, wherein: The longitudinal tip (20) of the drug delivery device does not require additional connection components.

9. The drug delivery device according to any one of claims 4 to 7, wherein: The adapter (130, 230) is bonded to the drug delivery device (10) only via the adhesive layer (40).

10. A drug delivery device according to any one of claims 3 to 7, wherein: The inner surface (134, 234) of the mounting ring (133, 233) is substantially parallel to the outer surface (20a) of the longitudinal tip (20).

11. A drug delivery device according to any one of claims 3 to 7, wherein: The longitudinal tip (20) is made of glass.

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