Tail cap assembly for injection system

Abstract

A tip cap assembly includes a rigid outer cap and an elastomeric inner cap. The rigid outer cap has a distal portion and a proximal portion. An inner surface of the distal portion defines a cavity configured to retain the elastomeric inner cap therein. An inner surface of the proximal portion defines a cavity, the cavity defined by the inner surface of the proximal portion being configured to surround a tip of the container when the tip cap assembly is assembled with the container. A sealing ring is bonded to an inner surface of the proximal portion of the rigid outer cap. An inner surface of the sealing ring is configured to engage the tip when the tip cap assembly is assembled with the container. The elastomeric inner cap is disposed within the cavity of the distal portion of the rigid outer cap.

Description

Technical Field

[0001] The present disclosure relates to a tip cap assembly for closing a fluid passage of a medical injection device, and an injection system comprising the injection device and the tip cap assembly. Background Art

[0002] Current medicine uses various injection devices to deliver fluid to the patient's body. For example, such an injection system can include an automatic syringe, a medical pen or a syringe. Traditional syringes are used because they are easily available, easy to use and cost-limited. The syringe can be pre-filled or pre-filled. The syringe includes a longitudinal barrel having an open proximal end and a substantially closed distal end, and the distal end includes a distally protruding end. The fluid intended to be injected can be stored in a syringe barrel, in which case the open proximal end is closed by a stopper, which is in a sliding fluid-tight engagement in the barrel and actuated by a plunger rod. The end is provided with a fluid passage extending therethrough to allow injection of fluid when distal pressure is applied to the plunger. The end can be provided with an attached needle, or can be a Luer type, which means needle-free. The syringe barrel can be made of glass or plastic. Glass may be selected for its chemical neutrality and low permeability, while plastic may be selected for its impact resistance.

[0003] Almost all fluids can be injected with a syringe. For example, the fluid can be a pharmaceutical solution, such as a medicine, vaccine, vitamin, or dietary mineral. Syringes can also be used to inject diagnostic solutions, cosmetic fluids, including gels such as hyaluronic acid or silicone compositions. Injections can be performed in every part of the body, including the skin, subcutaneous tissue, muscle, and vein, depending on the application.

[0004] The needle-free syringe may be provided with an adapter to which a device for allowing the transfer of fluid within the syringe for dispensing from the syringe is connected. In the case of a plastic syringe, the adapter may be integrally formed with the syringe body. For a glass syringe, the adapter may be formed separately and coupled to the syringe body.

[0005] In the time between filling and use of the syringe, the needle-free syringe is provided with an end cap to close the distally extending end. Examples of end caps are provided in WO2018 / 011259 and US11013865. The end cap engages with an adapter provided on the syringe body. Since the fluid is stored in the prefilled syringe for a long time, such as 6 to 18 months before injection, the injection system remains sealed during this time period. The quality of the seal between the end cap and the syringe is important because a poor seal may destroy the properties or purity of the fluid, resulting in a waste of precious fluid, a potential unacceptable risk to the patient, and a potential unacceptable risk to medical personnel, depending on the properties of the pharmaceutical composition stored inside the syringe.

[0006] For example, the outer surface of the distally extending tip should be protected from contaminants (such as dust or microorganisms) that may migrate from the tip to the fluid pathway. If these contaminants are injected into the patient along with the medicinal fluid, they may trigger an inappropriate immune response, reduce the effectiveness of the treatment, and reduce the patient's confidence in their treatment. Therefore, the entire or partial displacement of the tip cap that is intended to close the fluid pathway may lead to contamination of the medicinal fluid.

[0007] The force applied to engage the rigid tip cap with the adapter may be directly transmitted to the adapter. Due to excessive mechanical stress generated during or after assembly, crack(s) may form in the adapter and / or tip cap made of rigid material. Such crack(s) may result in poor connection of the adapter with an intravenous (IV) line, needle hub, or other device for subsequent assembly, may result in contamination of the fluid in the syringe, and / or may result in inadvertent exposure of the user to the fluid in the syringe.

[0008] Furthermore, the syringe should be easy to open when needed and the end cap should be easy to remove without excessive force. When the end cap is inserted on the end of the syringe, sticking may occur. It has been observed that such sticking may occur when two materials are compressed together for a long time and prevents quick and easy opening of the pre-filled syringe. Therefore, a difficult to open end cap will lead to the rejection of the pre-filled syringe before use and will constitute an unacceptable economic loss. This may also lead to the death or serious injury of the patient who needs an injection immediately. Summary of the invention

[0009] It is an object of the present disclosure to provide a tip cap assembly for closing a fluid passage extending through a tip of a container of a medical injection device that overcomes one or more of the above-mentioned disadvantages.

[0010] The end cap assembly includes a rigid outer cap and an elastomeric inner cap. The rigid outer cap has a distal portion and a proximal portion. The inner surface of the distal portion defines a cavity, which is configured to retain the elastomeric inner cap therein. The inner surface of the proximal portion defines a cavity, which is configured to surround the end of the container when the end cap assembly is assembled with the container. An elastomeric sealing ring is bonded to the inner surface of the proximal portion of the rigid outer cap. The inner surface of the sealing ring is configured to engage the end when the end cap assembly is assembled with the container. The elastomeric inner cap is disposed in the cavity of the distal portion of the rigid outer cap. When the end cap assembly is assembled with the container, the inner cap abuts against the distal surface of the end of the container.

[0011] Certain preferred but non-limiting features of the above-described end cap assembly are as follows, which features may be employed alone or in combination:

[0012] The inner surface of the sealing ring includes a plurality of ribs, and the surfaces of the ribs are configured to engage the outer surface of the end of the container;

[0013] The inner diameter of the sealing ring is smaller than the outer diameter of the terminal end, and the terminal cap assembly is configured to be disposed on the terminal end;

[0014] The height of the sealing ring is less than the height of the terminal, the terminal cap assembly is configured to be disposed on the terminal, and the height of the sealing ring is preferably 40% of the height of the terminal;

[0015] The elastomeric sealing ring comprises a thermoplastic elastomer; and / or

[0016] The rigid outer cap is made of a rigid polymer, preferably polypropylene, polyethylene, polyvinyl chloride, polystyrene, polycarbonate, acrylonitrile butadiene styrene or styrene acrylonitrile.

[0017] A method of forming the tip cap assembly includes co-molding the sealing ring to an inner surface of a proximal portion of the rigid outer cap.

[0018] Another object of the present disclosure is to provide an injection device, the injection device comprising a terminal cap assembly as previously described, a container, and an adapter. The container has a barrel and a terminal protruding distally from the barrel. The terminal includes a fluid passage extending longitudinally therethrough. The adapter is circumferentially arranged around the terminal of the container.

[0019] Some preferred but non-limiting features of the above injection device are as follows, which features may be employed alone or in combination:

[0020] The outer surface of the proximal portion of the rigid outer cap has a threaded surface;

[0021] The adapter includes a distal portion having a threaded inner surface, the threaded surface of the proximal portion of the rigid outer cap engaging the threaded inner surface of the adapter;

[0022] The elastomeric sealing ring of the end cap assembly is radially compressed between the rigid outer cap and the adapter;

[0023] The elastomeric inner cap is disposed on an end of the container to sealingly close the fluid passage; and / or

[0024] The elastomeric inner cap is axially compressed between the radially inwardly extending protrusion of the rigid outer cap and the end of the container to sealingly close the fluid passageway. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The illustrations presented herein are not actual views of any particular component, device, or system, but are merely idealized representations used to describe embodiments of the present invention. Other features, objects, and advantages of the present invention will become more apparent upon reading the following detailed description and with reference to the accompanying drawings provided by way of non-limiting example, in which:

[0026] Figure 1 is a cross-sectional view of an outer cap of an end cap assembly;

[0027] Figure 2 for Figure 1 a side view of an outer cap;

[0028] Figure 3 is a side view of an inner cap of an end cap assembly;

[0029] Figure 4 for Figure 1 A cross-sectional view of an outer cap of Figure 3 inner cap;

[0030] Figure 5 a cross-sectional view of a container with an adapter disposed thereon; and

[0031] Figure 6 and Figure 7 A side view and a cross-sectional view, respectively, of a container with an end cap assembly disposed thereon. DETAILED DESCRIPTION

[0032] As used herein, the term "proximal" refers to a position, such as a proximal end, that is closer to a reference point, such as a contact point for a user applying force to a plunger rod of an injection device as described herein. As used herein, the term "distal" refers to a position, such as a distal end, that is away from a reference point, such as a contact point for a user applying force to a plunger of an injection device as described herein. Thus, the terms "proximal" and "distal" refer, for example, to directions closer to and farther from a user administering a medicinal fluid to a patient, respectively.

[0033] As used herein, the terms "axial," "axially," "longitudinal," and "longitudinally" generally mean and refer to directions along or parallel to a longitudinal axis of an element(s) of the injection devices described herein.

[0034] As used herein, the terms "radial," "radially," "lateral," and "laterally" generally mean and refer to directions perpendicular to a central longitudinal axis of an element(s) of the injection devices described herein.

[0035] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0036] As used herein, the term "configured to" refers to the size, shape, material composition, material distribution, orientation, and arrangement of one or more of at least one structure and at least one device that facilitates operation of one or more of the structures and devices in a predetermined manner.

[0037] The tip cap assembly 100 disclosed herein includes an inner cap 130 and a rigid outer cap 102 . Figure 1 and 2 A rigid outer cap 102 of the tip cap assembly 100 is illustrated.

[0038] The outer cap 102 includes a distal portion 104 and a proximal portion 106. The outer cap 102 has a longitudinal axis 101 extending between its distal end 103 and proximal end 105. The outer cap 102 is a hollow body having an opening at each of its distal end 103 and proximal end 105.

[0039] The distal portion 104 includes a cavity 110 defined by an inner surface 108. Figure 4As illustrated in , the cavity 110 is configured to hold the inner cap 130 therein. As the cavity 110 extends from the distal end 103 toward the proximal end 105, the width of the inner surface 108 of the distal portion 104 decreases. A shoulder 107 is defined by the inner surface 108 of the distal portion 104, where the width of the cavity 110 decreases in a stepped manner. The shoulder 107 is configured such that when the inner cap 130 and the outer cap 102 are assembled together, a portion of the inner cap 130 is disposed on the shoulder.

[0040] The distal portion 104 of the outer cap 102 may include at least one protrusion 140 proximate the distal end 105. The protrusion 140(s) extend radially inward toward and longitudinally along the longitudinal axis 101 of the outer cap 102. The proximal end 141 of the protrusion 140 may be referred to as an abutment surface and is configured to abut against the distal surface 133 of the inner cap 130 when the inner cap 130 is disposed therein.

[0041] The proximal portion 106 includes a cavity 114 defined by its inner surface 112. The cavity 114 of the proximal portion 106 is continuous with the cavity 110 of the distal portion 104. Figure 7 As illustrated in FIG. 1 , when the tip cap assembly 100 is assembled with the container 10 , the cavity 114 is configured to receive and surround the tip 22 of the container 10 therein.

[0042] The sealing ring 120 is bonded to the inner surface 112 of the proximal portion 106 of the outer cap 102. The sealing ring 120 is made of a material that allows the sealing ring 120 to be radially compressible.

[0043] The sealing ring 120 is bonded to the inner surface 112 of the proximal portion 106 of the outer cap 102. Depending on the material composition of the sealing ring 120 and the outer cap 102, the sealing ring 120 and the proximal portion 106 may be bonded by a co-molding or overmolding process. In the co-molding process, the sealing ring 120 and the outer cap 102 may be formed substantially simultaneously by injection molding so that when the molten material of the sealing ring 120 and the outer cap 102 solidifies after being injected into the mold, the sealing ring 120 and the outer cap 102 are bonded together. In the overmolding process, the outer cap 102 may be injection molded and solidified before the material of the sealing ring 120 is injected into the mold, and the sealing ring 120 is bonded to the outer cap 102 when the molten material of the sealing ring 120 solidifies.

[0044] The sealing ring 120 may be made of an elastomeric material. The elastomeric material may be a thermoplastic elastomer. As a non-limiting example, the sealing ring 120 may be made of natural rubber, synthetic rubber, thermoplastic elastomer, or a combination thereof.

[0045] When the end cap assembly 100 is assembled with the container 20, the inner surface 122 of the sealing ring 120 is configured to directly engage the end 22 of the container 10. The sealing ring 120 includes a plurality of ribs 124 separated longitudinally by valleys, which are surfaces that are axially recessed relative to the ribs 124. As explained in further detail below, the surface of the ribs 124 (e.g., the surface area of ​​the sealing ring 120 that contacts the end 22) can be selected to vary the force applied by a machine and / or a user to axially displace the end cap assembly 100 onto and / or from the container 10.

[0046] When assembled with the tip cap assembly 100, the radially innermost surface of the rib 124 engages the lateral surface of the tip 22. The radially innermost surface of the inner seal ring 120 defines an inner diameter D of the seal ring 120. 120 The inner diameter D of the sealing ring 120 is 120 smaller than the outer diameter D of the end 22 of the container 20 22 The inner diameter D of the sealing ring 120 is 120 It is adjustable because the sealing ring 120 is radially compressible.

[0047] The proximal portion 106 includes an outer surface 118 having threads thereon. The threaded outer surface 118 is configured to engage with threads of the adapter 50, as discussed in further detail below.

[0048] The outer cap 102 is made of a rigid polymer. As non-limiting examples, the outer cap 102 is made of polypropylene, polyethylene, polyvinyl chloride, polystyrene, polycarbonate, acrylonitrile butadiene styrene, or styrene acrylonitrile.

[0049] The outer cap 102 may also include a ring 121 defining a portion of its outer surface 105. The ring 121 defines a proximal surface 123 that abuts against the adapter 50 when the tip cap assembly 100 is coupled to the adapter. The ring 121 may define a maximum radial dimension of the outer cap 102.

[0050] Figure 3 The inner cap 130 of the end cap assembly 100 is illustrated. Figure 4 The example illustrates that the inner cap 130 is disposed within the outer cap 102 .

[0051] The inner cap 130 includes a distal portion 132 and a proximal portion 134. A longitudinal axis 131 of the inner cap 130 extends between a distal surface 133 and a proximal surface 135 of the inner cap 130.

[0052] When the inner cap 130 is disposed within the outer cap 102 , the longitudinal axis 131 of the inner cap 130 may be coaxial with the longitudinal axis 101 of the outer cap 102 .

[0053] The distal portion 132 may be generally cylindrical in shape, with a planar distal surface 133. The proximal portion 134 may have a generally cylindrical first portion 134a proximate the distal portion 132 and a frustoconical second portion 134b at a proximal end thereof.

[0054] In some embodiments, the first portion 134a may have a spherical portion whose width increases near the second portion 134b. When the inner cap 130 is disposed within the outer cap 102, the spherical portion is radially compressed to retain the inner cap 130 within the cavity 110. The proximal portion 134 includes a planar proximal surface 135.

[0055] The width (eg, diameter) of the distal portion 132 is greater than the width of the proximal portion 134. The widths of the proximal and distal portions 134, 132 may be such that the inner cap 130 is radially compressed by the inner surface 108 of the cavity 110 when the inner cap 130 is disposed in the outer cap 102.

[0056] The inner cap 130 is formed separately from and assembled with the outer cap 102. The inner cap 130 may be inserted into the outer cap 102 by passing the inner cap 130 through an opening at the distal end 103 of the outer cap 102 and into the cavity 110 of the distal portion 106 of the outer cap 102.

[0057] When the inner cap 130 is disposed within the outer cap 102, the distal surface 133 of the distal portion 132 may abut against an abutment surface 141 of the protrusion 140 of the outer cap 102. The proximal surface 137 of the distal portion 132 may abut against the shoulder 107 of the outer cap 102.

[0058] The inner cap 130 can be made of an elastomeric material. Suitable materials for the inner cap 130 can include natural rubber, acrylate-butadiene rubber, butadiene rubber, chloro- or bromo-butyl rubber, chlorinated polyethylene elastomer, polyoxyalkylene polymer, ethylene-vinyl acetate, fluorosilicone rubber, hexafluoropropylene-vinylidene fluoride-tetrafluoroethylene terpolymer, butyl rubber, polyisobutylene, synthetic polyisoprene rubber, silicone rubber, styrene-butadiene rubber, tetrafluoroethylene propylene copolymer, thermoplastic copolyester, thermoplastic elastomer, etc. or a combination thereof.

[0059] The outer cap 102 in which the inner cap 130 is arranged can be assembled with the injection device 1 . Figure 5-7 An injection device 1 in the form of a Luer syringe according to aspects of the present disclosure is shown. The tip cap assembly 100 of the present disclosure can be used in any other type of injection system, such as a pen or an infusion system, as long as they include a distally protruding tip. For clarity, the present disclosure will only be described using a Luer syringe.

[0060] The injection device 1 comprises a container 10. The container 10 comprises a barrel 11 extending axially along a longitudinal axis A. The container 10 is configured to contain a medicinal fluid therein. The barrel 11 comprises a flange 12 at a proximal end and a tip 22 at a distal end. The tip 22 comprises a fluid passage 14 extending therethrough, a distal surface 15 and a substantially tubular lateral surface 16. Although in Figure 6 and 7 It is not illustrated in FIG. 1 , but the injection device 1 may also include a bung coupled to the plunger. In operation, a user depresses the plunger to displace the bung and dispense the medicinal fluid from the container 10 through the fluid passage 14 of the distal end 22 .

[0061] Tip 22 may be configured to connect to an additional component, such as a needle hub or an intravenous (IV) line, thereby allowing the medicinal fluid contained in barrel 11 to be expelled through fluid passage 14 and further injected into a predetermined target.

[0062] The barrel 11 and the tip 22 may be made of glass or plastic.

[0063] The adapter 50 is securely engaged with the tip 22. The adapter 50 may be formed separately and fixedly attached to the injection device 1 by clamping, threading, welding, adhesive etc. Alternatively, the adapter 50 may be integrally formed with the barrel 11, such as by moulding.

[0064] exist Figure 5 The adapter 50 best illustrated in FIG. 1 surrounds the tip 22 to define an annular space 52 therebetween for receiving the proximal portion 106 of the outer cap 102. The inner surface 54 of the adapter 50 includes threads to engage threads on the outer surface 118 of the proximal portion 106 of the outer cap 102.

[0065] The adapter 50 may be made of a plastic material. As non-limiting examples, the adapter 50 may be made of acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polyoxymethylene (POM), polystyrene (PS), polybutylene terephthalate (PBT), polypropylene (PP), polyethylene (PE), polyamide (PA), thermoplastic elastomer (TPE), and combinations thereof.

[0066] The tip cap assembly 100 is coupled to the adapter 50 by engaging the threaded outer surface 118 of the outer cap 102 with the threaded inner surface 54 of the adapter 50. When assembled together, the proximal portion 106 of the outer cap 102 is disposed in the annular space 52 and surrounds the tip 22 of the injection device 1 .

[0067] When assembled, the proximal surface 107 of the ring 121 of the outer cap 102 abuts against the distal end of the adapter 50 .

[0068] When assembled, the inner cap 130 is axially compressed between the tip 22 of the injection device 1 and the abutment surface 141 of the protrusion 140(s) of the outer cap 102. More particularly, the proximal surface 135 of the inner cap 130 abuts against the distal surface 15 of the tip 22, and the distal surface 133 of the inner cap 130 abuts against the abutment surface 141 of the protrusion 140 of the outer cap 102. The placement of the inner cap 130 between the protrusion 140 and the tip 22 maintains the inner cap 130 in position within the outer cap 102 during sterilization and during subsequent storage of the injection device 1 until the user is ready to use the injection device 1 to dispense a medical fluid therefrom.

[0069] The proximal portion 134 of the inner cap 130 may partially protrude into the fluid passage 14 of the injection device 1. The positioning of the inner cap 130 against the tip 22 seals the fluid passage 14 of the injection device 1 and prevents fluid from flowing out of the injection device 1. The engagement of the inner cap 130 and the tip 22 also prevents any contamination of the medical fluid disposed in the container 10 by the external environment, thereby ensuring the integrity of the container closure.

[0070] In addition, the inner cap 130 is sized to be radially compressed along at least a portion of its length. For example, the convex portion of the proximal portion 134 can be radially compressed to a greater extent relative to the remainder of the first portion 134a. The radial compression of the inner cap 130 maintains the inner cap 130 in a suitable position within the outer cap 102 during sterilization and during subsequent storage of the injection device 1 until the user is ready to use the injection device 1 to dispense medical fluid therefrom. Maintaining the inner cap 130 in its installed position within the outer cap 102 maintains the fluid seal of the inner cap 130 to the end 22 to prevent contamination of the medicinal fluid in the container 10.

[0071] The shape and size of the inner cap 130 are set so that the inner cap 130 does not surround the lateral surface of the terminal end 22. Instead, the lateral surface 16 of the terminal end 22 engages with the rib 124 of the sealing ring 120 of the terminal cap assembly 100. When the terminal cap assembly 100 is assembled with the container, because the inner cap 130 does not engage with the lateral surface 16 of the terminal end 22, the inner cap 130 is not easily displaced from its seated position in the cavity 110 of the rigid cap 102 compared to an inner cap having a proximal portion that at least partially surrounds the lateral surface 16 of the terminal end 22 when assembled with the terminal 22.

[0072] A seal may be formed between the radially innermost surface 122 of the rib 124 of the sealing ring 120 and the lateral surface 16 of the tip 22 to ensure the integrity of the container closure so as to prevent any contamination of the medical fluid within the container 10 by the external environment.

[0073] The radially innermost surface 122 of the rib 124 directly contacts the lateral surface 16 of the tip 22 of the container 10. During assembly, when the tip cap assembly 100 and the injection device 1 are assembled together, the sealing ring 120 of the tip cap assembly 100 is radially compressed between the rigid outer cap 102 and the adapter 50. Due to the inner diameter D of the sealing ring 120 120 and the outer diameter D of the end 22 on which the end cap assembly 100 is disposed 22 The relative size of the sealing ring 120 is radially compressed. More specifically, the inner diameter D of the sealing ring 120 120 Smaller than the outer diameter D of the end 22 22 As a non-limiting example, the inner diameter D 120 It can be larger than the outer diameter D of the end 22 22 5% to 20% smaller.

[0074] The height L of the sealing ring 120 120 or the axial dimension is smaller than the height L of the end 22 of the container 10 22 In some embodiments, the height L of the sealing ring 120 is 120 The height L of the end 22 of the container 10 may be 22 The valleys between the ribs 124 on the inner surface 122 of the sealing ring 120 are also configured to reduce the contact area between the sealing ring 120 and the tip 22, which also reduces the force required to remove the tip cap assembly 100 from the container 10. The surface area of ​​the ribs 124 (which defines the contact area where the sealing ring 120 is in direct contact with the tip 22) can be selected to change the force applied by the machine and / or user to axially displace the tip cap assembly 100 onto and / or from the container 10.

[0075] The provision of the sealing ring 120 made of a compressible material absorbs part of the compressive force between the adapter 50, the proximal portion 106 of the rigid cap 102, and the tip 22 when assembled together. By providing a compressible material of the sealing ring 120, the proximal portion 106 made of a rigid polymeric material is less likely to break due to the compressive force than a rigid cap having the proximal portion as a unitary piece made of a rigid material, the unitary piece having threads on the outer surface in contact with the adapter 50 and ribs on the inner surface in contact with the lateral surface 16 of the tip 22. The rupture of the rigid cap 102 compromises the integrity of the container closure. Therefore, when the tip cap assembly 100 is assembled with a container 10 made of glass or plastic, the tip cap assembly 100 according to the present disclosure is less likely to break.

[0076] The tip cap assembly 100 is assembled to the container 10 by engaging the threaded surface 188 of the outer cap 102 with the threaded inner surface 54 of the adapter 50. As the tip cap assembly 100 is rotated to engage with the adapter 50, the sealing ring 120 slides along the lateral surface 16 of the tip 22 of the container 10. Various dimensions of the sealing ring 120 can be selected to control the friction between the sealing ring 120 and the tip 22, and thereby control the torque applied to engage and disengage the tip cap assembly 100 from both the adapter 50 and the container 10.

[0077] Although the present disclosure has been described herein with respect to certain illustrative embodiments, it will be recognized and appreciated by those of ordinary skill in the art that the present disclosure is not limited thereto. Rather, many additions, deletions, and modifications may be made to the illustrative embodiments without departing from the scope of the present disclosure, including their legal equivalents. Additionally, features of one embodiment may be combined with features of another embodiment while still being within the scope of the invention contemplated by the inventor.

Claims

1. A tip cap assembly (100) for closing a fluid passage extending through a tip (22) of a container (20) of a medical injection device (10), the tip cap assembly (100) comprising: A rigid outer cap (102) having a distal portion (104) and a proximal portion (106), wherein: An inner surface (108) of the distal portion (104) defines a cavity (110) configured to retain an elastomeric inner cap (130) therein; and The inner surface (112) of the proximal portion (106) defines a cavity (114), the cavity defined by the inner surface of the proximal portion being configured to surround the tip (22) of the container (20) when the tip cap assembly (100) is assembled with the container (20); and a sealing ring (120) coupled to an inner surface (112) of a proximal portion (106) of the rigid outer cap (102), the inner surface (122) of the sealing ring (120) being configured to engage the tip (22) when the tip cap assembly (100) is assembled with the container (20); and The elastomeric inner cap (130) is disposed within the cavity (110) of the distal portion (104) of the rigid outer cap (102), and when the end cap assembly (100) is assembled with the container (20), the elastomeric inner cap (130) abuts against the distal surface of the end (22) of the container (20).

2. The end cap assembly (100) according to claim 1, wherein: The inner surface (122) of the sealing ring (120) includes a plurality of ribs (124), and the surfaces (126) of the ribs (124) are configured to engage the outer surface of the end (22) of the container (20).

3. The tip cap assembly (100) according to any one of claims 1 or 2, wherein: The inner diameter (D 120 ) is smaller than the outer diameter (D 22 ), the end cap assembly (100) is configured to be disposed on the end.

4. The tip cap assembly (100) according to any one of claims 1 to 3, wherein: The height (L 120 ) is less than the height (L) of the end (22) 22 ), the end cap assembly (100) is configured to be arranged on the end, preferably, the height (L 120 ) is the height (L) of the end (22) 22 ).

5. The tip cap assembly (100) according to any one of claims 1 to 4, wherein: The sealing ring (120) made of elastomeric material includes a thermoplastic elastomer.

6. The tip cap assembly (100) according to any one of claims 1 to 5, wherein: The rigid outer cap (102) is made of a rigid polymer, preferably polypropylene, polyethylene, polyvinyl chloride, polystyrene, polycarbonate, acrylonitrile butadiene styrene or styrene acrylonitrile.

7. An injection device (1), comprising: a container (20) having a barrel (24) and a tip (22) projecting distally from the barrel (24), the tip (22) including a fluid passage (26) extending longitudinally therethrough; an adapter (50) disposed circumferentially around the end (22) of the container (20); as well as The tip cap assembly (100) according to any one of claims 1 to 6, wherein the tip cap assembly is coupled to the adapter (50).

8. The injection device (1) according to claim 7, wherein: The outer surface (116) of the proximal portion (106) of the rigid outer cap (102) has a threaded surface (118).

9. The injection device (1) according to claim 8, wherein: The adapter (50) includes a distal portion (52) having a threaded inner surface (54), and the threaded surface (118) of the proximal portion (106) of the rigid outer cap (102) engages the threaded inner surface (54) of the adapter (50).

10. The injection device (1) according to any one of claims 7 to 9, wherein: The elastomeric sealing ring (120) of the end cap assembly (100) is radially compressed between the rigid outer cap (102) and the adapter (50).

11. The injection device (1) according to any one of claims 7 to 10, wherein: The elastomeric inner cap (130) is disposed on the end (22) of the container (20) to sealingly close the fluid passage (26).

12. The injection device (1) according to any one of claims 7 to 11, wherein: The elastomeric inner cap (130) is axially compressed between a radially inwardly extending protrusion (140) of the rigid outer cap (102) and the end (22) of the container (20) to sealingly close the fluid passageway (26).

13. A method of forming an end cap assembly according to any one of claims 1 to 6, comprising: The sealing ring (120) is co-molded to the inner surface (112) of the proximal portion (106) of the rigid outer cap (102).

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