TIP CAP ASSEMBLY FOR INJECTION SYSTEM - Patent application

Abstract

The 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. The inner surface of the distal portion defines a cavity configured to retain the elastomeric inner cap therein. The inner surface of the proximal portion defines a cavity configured to surround the distal end of the container when the tip cap assembly is assembled with the container. A 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 distal end when the tip cap assembly is assembled with the container. The elastomeric inner cap is disposed within the cavity in the distal portion of the rigid outer cap.

Description

[Technical Field]

[0001] SUMMARY The present disclosure relates to a tip cap assembly for closing a fluid passageway in a medical injection device, and to an injection system including the injection device and the tip cap assembly. [Background technology]

[0002] In modern medicine, a wide range of injection devices are used to deliver fluids into a patient's body. For example, such injection systems may include auto-injectors, medical pens, or syringes. Traditional syringes are used due to their general availability, ease of use, and limited cost. Syringes may be prefilled or prefillable. A syringe comprises a longitudinal barrel having an open proximal end and a substantially closed distal end including a distally protruding tip. The fluid to be injected may be stored within the syringe barrel, where the open proximal end is closed by a stopper in sliding fluid-tight engagement within the barrel and actuated by a plunger rod. The tip is provided with a fluid passage extending therethrough to allow injection of the fluid when distal pressure is applied to the plunger. The tip may be provided with an attached needle or may be a Luer type, meaning needleless. Syringe barrels may be made of glass or plastic. Glass may be selected for its chemical neutrality and low gas permeability, while plastic may be selected for its impact resistance.

[0003] Almost any fluid can be injected with a syringe. For example, the fluid can be a pharmaceutical solution, such as a drug, vaccine, vitamin, or dietary mineral. Syringes are also useful for injecting diagnostic solutions and cosmetic fluids, including gels such as hyaluronic acid or silicone compositions. Injections can be made into any part of the body, including the skin, subcutaneous tissue, muscle, or vein, depending on the application.

[0004] Needleless syringes are provided with adapters to allow transfer of the liquid in the syringe from which the device is dispensed. In the case of plastic syringes, the adapter may be integrally formed with the syringe body. In the case of glass syringes, the adapter may be separately formed and coupled to the syringe body.

[0005] A needleless syringe is provided with a tip cap to close the distal end of the syringe between filling and use. Examples of tip caps are described in International Publication No. 2018 / 011259 and U.S. Patent No. 1,101,3865. The tip cap engages with an adapter attached to the syringe body. Because fluids are stored in prefilled syringes for extended periods, such as 6 to 18 months, prior to injection, the injection system remains sealed during this period. The quality of the seal between the tip cap and the syringe is important because a faulty seal can compromise the quality or purity of the fluid, leading to waste of valuable fluid, potential unacceptable risks to patients, and potential unacceptable risks to medical staff depending on the nature of the pharmaceutical composition stored in 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 into the fluid passageway. If these contaminants are injected into a patient along with the medicated fluid, they may trigger an inappropriate immune response, reducing the effectiveness of the treatment and reducing the patient's confidence in the treatment. Therefore, displacement of all or part of the tip cap to close the fluid passageway may result in contamination of the medicated fluid.

[0007] Forces applied when attempting to engage a rigid tip cap with an adapter may be transmitted directly to the adapter. Crack(s) may form in the adapter and / or the tip cap, which is made of a rigid material, due to excessive mechanical stresses generated during or after assembly. Such crack(s) may lead to a poor connection between the adapter and an intravenous (IV) line, needle hub, or other device for subsequent assembly, may lead to contamination of the fluid in the syringe, and / or may lead to unintended exposure of the user to the fluid in the syringe.

[0008] Furthermore, syringes should be easy to open when needed, and tip caps should be removed without excessive force. Sticking can occur when tip caps are inserted onto the tip of a syringe. It has been observed that this sticking occurs when two materials are compressed together for a long period of time, preventing quick and easy opening of prefilled syringes. Consequently, difficult-to-open tip caps can lead to the disposal of prefilled syringes before use, resulting in unacceptable economic losses. This can also lead to death or serious injury to patients who require immediate injections. Summary of the Invention

[0009] SUMMARY OF THE DISCLOSURE An object of the present disclosure is a tip cap assembly for closing a fluid passageway extending through the tip of a container of a medical infusion device, which overcomes one or more of the aforementioned drawbacks.

[0010] The 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. The inner surface of the distal portion defines a cavity configured to retain the elastomeric inner cap therein. The inner surface of the proximal portion defines a cavity configured to surround the distal end of the container when the tip 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 distal end when the tip cap assembly is assembled with the container. The elastomeric inner cap is disposed within the cavity in the distal portion of the rigid outer cap. The inner cap abuts against the distal surface of the distal end of the container when the tip cap assembly is assembled with the container.

[0011] Preferred but non-limiting features of the tip cap assembly described above, individually or in combination, are as follows:

[0012] The inner surface of the seal ring includes a plurality of ribs, the rib surfaces being configured to engage the outer surface of the tip of the container.

[0013] The inner diameter of the seal ring is smaller than the outer diameter of the tip onto which the tip cap assembly is configured to be disposed.

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

[0015] the elastomeric sealing ring comprises a thermoplastic elastomer, and / or

[0016] The rigid outer cap is made of a rigid polymer, which is 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 a sealing ring to the inner surface of the proximal portion of the rigid outer cap.

[0018] Another object of the present disclosure is an injection device comprising a tip cap assembly as described above, a container, and an adapter. The container has a barrel and a tip projecting distally from the barrel. The tip has a fluid passage extending longitudinally therethrough. The adapter is disposed circumferentially around the tip of the container.

[0019] Preferred but non-limiting features of the above-described injection device include, individually 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 interior surface, the threaded surface of the proximal portion of the rigid outer cap being engaged with the threaded interior surface of the adapter.

[0022] The elastomeric seal ring of the tip cap assembly is radially compressed between the rigid outer cap and the adapter.

[0023] an elastomeric inner cap disposed at the distal end of the container to seal and close the fluid passageway; and / or

[0024] The elastomeric inner cap is compressed axially between the radially inwardly extending projections of the rigid outer cap and the tip of the container to seal and close the fluid passageway. [Brief explanation of the drawings]

[0025] The illustrations presented herein are not meant to be actual diagrams of particular components, devices, or systems, but are merely idealized representations employed to describe embodiments of the present invention. Other features, goals, and advantages of the present invention will appear more clearly upon reading the following detailed description and by reference to the drawings, which are provided as non-limiting examples.

[0026] [Figure 1] FIG. 1 is a cross-sectional view of the outer cap of the tip cap assembly. [Figure 2] FIG. 2 is a side view of the outer cap of FIG. [Figure 3] FIG. 3 is a side view of the inner cap of the tip cap assembly. [Figure 4] FIG. 4 is a cross-sectional view of the outer cap of FIG. 1 with the inner cap of FIG. 3 disposed therein. [Figure 5] FIG. 5 is a cross-sectional view of a container having an adapter disposed thereon. [Figure 6] FIG. 6 is a side view of a container having a tip cap assembly disposed thereon. [Figure 7] FIG. 7 is a cross-sectional view of a container having a tip cap assembly disposed thereon. DETAILED DESCRIPTION OF THE INVENTION

[0027] Detailed Description As used herein, the term "proximal" refers to a location, such as the proximal end, that is closer to a reference point, such as the point of contact of a user applying a force to the plunger rod of an injection device described herein. As used herein, the term "distal" refers to a location, such as the distal end, that is farther from a reference point, such as the point of contact of a user applying a force to the plunger of an injection device described herein. Thus, the terms "proximal" and "distal" refer to directions closer to and farther from, respectively, a user administering, for example, a medical fluid to a patient.

[0028] As used herein, the terms "axial," "axially," "longitudinal," and "longitudinally" generally mean and refer to directions along or parallel to the longitudinal axis of an element or elements of an injection device described herein.

[0029] As used herein, the terms "radial," "radially," "lateral," and "laterally" generally mean and refer to directions perpendicular to the central, longitudinal axis of the element or elements of the infusion device described herein.

[0030] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0031] As used herein, the term "configured" refers to one or more of the size, shape, material composition, material distribution, orientation, and arrangement of at least one structure and at least one device to facilitate operation of one or more of the structure and device in a predetermined manner.

[0032] The tip cap assembly 100 disclosed herein comprises a rigid outer cap 102 and an inner cap 130. Figures 1 and 2 show the rigid outer cap 102 of the tip cap assembly 100.

[0033] Outer cap 102 includes a distal portion 104 and a proximal portion 106. Outer cap 102 has a longitudinal axis 101 extending between its distal end 103 and its proximal end 105. Outer cap 102 is hollow with an opening at each of its distal end 103 and proximal end 105.

[0034] Distal portion 104 includes a cavity 110 defined by an inner surface 108. As shown in FIG. 4, cavity 110 is configured to retain inner cap 130 therein. Inner surface 108 of distal portion 104 decreases in width as cavity 110 extends from distal end 103 toward proximal end 105. A shoulder 107 is defined by inner surface 108 of distal portion 104 where the width of cavity 110 gradually decreases. Shoulder 107 is configured to allow a portion of inner cap 130 to be disposed over it when inner cap 130 and outer cap 102 are assembled together.

[0035] The distal portion 104 of the outer cap 102 may include at least one protrusion 140 proximate the distal end 105. The protrusion(s) 140 extend radially inward and longitudinally toward the longitudinal axis 101 of the outer cap 102. A proximal end 141 of the protrusion 140, which may be referred to as an abutment surface, is configured to abut against the distal surface 133 of the inner cap 130 when the inner cap 130 is disposed therein.

[0036] 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. As shown in FIG. 7 , the cavity 114 is configured to receive and surround the tip 22 of the container 10 therein when the tip cap assembly 100 is assembled with the container 10.

[0037] Sealing ring 120 is coupled to the inner surface 112 of proximal portion 106 of outer cap 102. Sealing ring 120 is made of a material such that sealing ring 120 is radially compressible.

[0038] 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 and the proximal portion 106 may be bonded together by a co-molding or overmolding process, depending on the material compositions of the sealing ring 120 and the outer cap 102. In a co-molding process, the sealing ring 120 and the outer cap 102 may be formed substantially simultaneously by injection molding, such that the sealing ring 120 and the outer cap 102 are bonded together as the molten material of the sealing ring 120 and the outer cap 102 solidifies after injection into a mold. In an overmolding process, the outer cap 102 may be injection molded and solidified before the material of the sealing ring 120 is injected into a mold, such that the sealing ring 120 is bonded onto the outer cap 102 as the molten material of the sealing ring 120 solidifies.

[0039] The sealing ring 120 may be made of an elastomeric material. The elastomeric material may be a thermoplastic elastomer. By way of non-limiting example, the sealing ring 120 may be made of natural rubber, synthetic rubber, a thermoplastic elastomer, or a combination thereof.

[0040] An inner surface 122 of the sealing ring 120 is configured to directly engage the tip 22 of the container 10 when the tip cap assembly 100 is assembled with the container 20. The sealing ring 120 includes a plurality of ribs 124 separated longitudinally by valleys, which are axially recessed surfaces relative to the ribs 124. As described in further detail below, the surfaces of the ribs 124 (e.g., the surface areas of the sealing ring 120 that contact the tip 22) may be selected to modify the force applied by a machine and / or user to axially displace the tip cap assembly 100 onto and / or off the container 10.

[0041] The radially innermost surface of the rib 124 engages the lateral surface of the tip 22 when the tip cap assembly 100 is assembled therewith. The radially innermost surface of the inner seal ring 120 is aligned with the inner diameter D of the seal ring 120. 120The inner diameter D of the seal ring 120 is defined as 120 is the outer diameter D of the tip 22 of the container 20 22 The inner diameter D of the seal ring 120 is smaller than 120 is adjustable because the seal ring 120 is radially compressible.

[0042] Proximal portion 106 includes an outer surface 118 having threads thereon. Threaded outer surface 118 is configured to engage threads on adapter 50, as described in more detail below.

[0043] The outer cap 102 is made of a rigid polymer. By way of non-limiting example, the outer cap 102 is made of polypropylene, polyethylene, polyvinyl chloride, polystyrene, polycarbonate, acrylonitrile butadiene styrene, or styrene acrylonitrile.

[0044] The outer cap 102 may include a ring 121 that defines a portion of its outer surface 105. The ring 121 defines a proximal surface 123 that abuts the adapter 50 when the tip cap assembly 100 is coupled thereto. The ring 121 may define the maximum radial dimension of the outer cap 102.

[0045] FIG. 3 shows the inner cap 130 of the tip cap assembly 100, and FIG. 4 shows the inner cap 130 disposed within the outer cap 102.

[0046] Inner cap 130 includes a distal portion 132 and a proximal portion 134. A longitudinal axis 131 of inner cap 130 extends between a distal surface 133 and a proximal surface 135 of inner cap 130.

[0047] 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 .

[0048] Distal portion 132 may be generally cylindrical in shape with a planar distal surface 133. Proximal portion 134 may have a generally cylindrical first portion 134a immediately adjacent distal portion 132 and a cone-shaped second portion 134b at its proximal end.

[0049] In some embodiments, first portion 134a may have a bulbous portion that increases in width proximate second portion 134b. The bulbous portion is radially compressed when inner cap 130 is placed within outer cap 102 to retain inner cap 130 within cavity 110. Proximal portion 134 includes a planar proximal surface 135.

[0050] Distal portion 132 has a width (e.g., diameter) that is greater than the width of proximal portion 134. The widths of proximal portion 134 and distal portion 132 may be such that when inner cap 130 is placed within outer cap 102, inner cap 130 is radially compressed by inner surface 108 of cavity 110.

[0051] 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 in the distal end 103 of the outer cap 102 and into the cavity 110 in the distal portion 106 of the outer cap 102.

[0052] When inner cap 130 is placed within outer cap 102, distal surface 133 of distal portion 132 may abut against abutment surface 141 of protrusion 140 on outer cap 102. Proximal surface 137 of distal portion 132 may abut against shoulder 107 on outer cap 102.

[0053] The inner cap 130 may be formed of an elastomeric material. Suitable materials for the inner cap 130 may include natural rubber, acrylate-butadiene rubber, cis-polybutadiene, chloro- or bromobutyl rubber, chlorinated polyethylene elastomer, polyalkylene oxide polymer, ethylene vinyl acetate, fluorosilicone rubber, hexafluoropropylene-vinylidene fluorotetrafluoroethylene terpolymer, butyl rubber, polyisobutene, synthetic polyisoprene rubber, silicone rubber, styrene-butadiene rubber, tetrafluoroethylene propylene copolymer, thermoplastic copolyester, thermoplastic elastomer, and the like, or combinations thereof.

[0054] The outer cap 102 may have an inner cap 130 disposed therein and be assembled with an injection device 1. Figures 5-7 show an injection device 1 in the form of a Luer syringe according to one embodiment of the present disclosure. The tip cap assembly 100 of the present disclosure may be used with any other type of injection system, such as a pen or infusion system, provided that it includes a distally protruding tip. For clarity, the present disclosure will be described only with respect to a Luer syringe.

[0055] Injection device 1 includes a container 10. Container 10 includes a barrel 11 extending axially along a longitudinal axis A. Barrel 11 includes a flange 12 at a proximal end and a tip 22 at a distal end. Tip 22 includes a fluid passageway 14 extending therethrough, a distal surface 15, and a substantially tubular lateral surface 16. Although not shown in FIGS. 6 and 7 , injection device 1 may further include a stopper coupled to the plunger. In operation, a user depresses the plunger to displace the stopper and expel the medicament through fluid passageway 14 in tip 22.

[0056] Tip 22 may be configured to be connected to additional elements, such as a needle hub or an intravenous (IV) line, thereby allowing the medicinal fluid contained in barrel 11 to be expelled and further injected into the intended subject through fluid passageway 14.

[0057] The barrel 11 and tip 22 may be made of glass or plastic.

[0058] 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 clips, screwing, welding, adhesive, etc. Alternatively, the adapter 50 may be integrally formed with the barrel 11, such as by molding.

[0059] 5, the adapter 50 surrounds the distal end 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 for engaging threads on the outer surface 118 of the proximal portion 106 of the outer cap 102.

[0060] The adapter 50 may be made of a plastic material. By way of non-limiting example, 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.

[0061] Tip cap assembly 100 is coupled to adapter 50 by engaging threaded outer surface 118 of outer cap 102 with threaded inner surface 54 of adapter 50. When assembled together, proximal portion 106 of outer cap 102 is disposed within annular space 52 and surrounds tip 22 of injection device 1.

[0062] When assembled, the proximal surface 107 of the ring 121 of the outer cap 102 abuts the distal end of the adapter 50 .

[0063] When assembled, the inner cap 130 is axially compressed between the tip 22 of the injection device 1 and the abutment surfaces 141 of the protrusion(s) 140 on the outer cap 102. More specifically, the proximal surface 135 of the inner cap 130 abuts the distal surface 15 of the tip 22, and the distal surface 133 of the inner cap 130 abuts the abutment surfaces 141 of the protrusions 140 on the outer cap 102. The seating of the inner cap 130 between the protrusions 140 and the tip 22 maintains the inner cap 130 in place within the outer cap 102 during the sterilization process and during subsequent storage of the device 1 until a user is ready to use the device 1 to dispense medical fluid therefrom.

[0064] A proximal portion 134 of the inner cap 130 may protrude partially into the fluid passageway 14 of the injection device 1. Positioning of the inner cap 130 against the tip 22 seals the fluid passageway 14 of the injection device 1 and prevents fluid from exiting the injection device 1. The engagement of the inner cap 130 with the tip 22 also prevents contamination of the medical fluid disposed within the container 10 from the outside environment, thereby ensuring the integrity of the container closure.

[0065] Additionally, inner cap 130 is sized to be radially compressed along at least a portion of its length. For example, the bulbous portion of proximal portion 134 may be radially compressed more than the remainder of first portion 134a. Radial compression of inner cap 130 maintains inner cap 130 in place within outer cap 102 during the sterilization process and subsequent storage of device 1 until a user is ready to use device 1 to dispense medical fluid therefrom. Maintaining inner cap 130 in a seated position with outer cap 102 maintains a fluid seal between inner cap 130 and tip 22 and avoids contamination of the medical fluid within container 10.

[0066] The inner cap 130 is shaped and sized such that the inner cap 130 does not surround the lateral surface 16 of the tip 22. Rather, the lateral surface 16 of the tip 22 engages with the ribs 124 of the seal ring 120 of the tip cap assembly 100. Because the inner cap 130 does not engage the lateral surface 16 of the tip 22 when the tip cap assembly 100 is assembled with the container, the inner cap 130 is less likely to shift from its seated position in the cavity 112 of the rigid cap 102 compared to an inner cap having a proximal portion configured to at least partially surround the lateral surface 16 of the tip 22 when assembled therewith.

[0067] 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 and inhibit contamination of the medical fluid disposed within the container 10 from the external environment.

[0068] 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, the sealing ring 120 of the tip cap assembly 100 is radially compressed between the rigid outer cap 102 and the adapter 50 when the tip cap assembly 100 and the injection device 1 are assembled together. The sealing ring 120 is radially compressed between the inner diameter D of the sealing ring 120 and the rigid outer cap 102. 120 and the outer diameter D of the tip 22 on which the tip cap assembly 100 is disposed. 22 More specifically, the inner diameter D of the seal ring 120 is 120 is the outer diameter D of the tip 22 22 As a non-limiting example, the inner diameter D 120 is the outer diameter D of the tip 22 22 It may be 5 to 20% smaller than

[0069] Seal ring 120 height L 120 , or the axial dimension is the height L of the tip 22 of the container 10 22 In some embodiments, the height L of the seal ring 120 is smaller than 120is the height L of the tip 22 of the container 10 22 The ribs 124 may be 30-50%, more particularly 40%, of the seal ring 120. The valleys between the ribs 124 on the inner surface 122 of the seal ring 120 are also provided to reduce the contact area between the seal 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 that define the contact area of the seal ring 120 that directly contacts the tip 22 may be selected to modify the force that a machine and / or user must apply to axially displace the tip cap assembly 100 onto and / or from the container 10.

[0070] Providing the sealing ring 120 made from a compressible material absorbs a portion of the compressive forces present between the adapter 50, the proximal portion 106 of the rigid cap 102, and the tip 22 when assembled together. By providing the compressible material of the sealing ring 120, the proximal portion 106 made from a rigid polymeric material is less prone to cracking as a result of compressive forces compared to a rigid cap that is a single piece of rigid material, with threads on its outer surface where the proximal portion contacts the adapter 50 and ribs on its inner surface where it contacts the lateral surface 16 of the tip 22. Cracking of the rigid cap 102 would compromise the integrity of the container closure. The tip cap assembly 100 according to the present disclosure is therefore less prone to cracking when the tip cap assembly 100 is assembled with a container 10 made from glass or plastic.

[0071] The tip cap assembly 100 is assembled onto 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 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 may be selected to control the frictional forces between the sealing ring 120 and the tip 22, and therefore the torque forces applied to engage and disengage the tip cap assembly 100 with the adapter 50 and container 10.

[0072] While the present disclosure has been described herein with reference to specific illustrated embodiments, those skilled in the art will recognize and understand that it is not so limited. Rather, many additions, deletions, and modifications to the illustrated embodiments may be made without departing from the scope of the present disclosure, including its legal equivalents. Additionally, features from one embodiment may be combined with features of another embodiment while remaining within the scope of the invention as contemplated by the inventors.

Claims

1. A tip cap assembly (100) for closing a fluid passage extending through the tip (22) of a container (20) of a medical infusion device (10), wherein the tip cap assembly (100) is A rigid outer cap (102) having an end portion (104) and a base portion (106), The inner surface (108) of the end portion (104) defines a cavity (110) configured to hold an elastomer inner cap (130) therein, and The inner surface (112) of the base portion (106) defines a rigid outer cap (102) that, when the tip cap assembly (100) is assembled with the container (20), defines a cavity (114) that surrounds the tip (22) of the container (20), and A seal ring (120) coupled to the inner surface (112) of the base end portion (106) of the rigid outer cap (102), wherein the inner surface (122) of the seal ring (120) is configured to engage with the tip (22) when the tip cap assembly (100) is assembled with the container (20), and The elastomer inner cap (130) is positioned within the cavity (110) of the end portion (104) of the rigid outer cap (102), and the inner cap (130) abuts against the end surface of the tip (22) of the container (20) when the tip cap assembly (100) is assembled with the container (20), in the tip cap assembly (100).

2. The tip cap assembly (100) according to claim 1, wherein the inner surface (122) of the seal ring (120) is provided with a plurality of ribs (124), and the surfaces (126) of the ribs (124) are configured to engage with the outer surface of the tip (22) of the container (20).

3. The inner diameter (D) of the seal ring (120) 120 The outer diameter (D) of the tip (22) is such that the tip cap assembly (100) is positioned. 22 A tip cap assembly (100) according to claim 1, which is smaller than ).

4. The height (L) of the seal ring (120) 120 ) is the height (L) of the tip (22) configured so that the tip cap assembly (100) is positioned. 22 ) is smaller than, preferably the height (L) of the seal ring. 120 ) is the height (L) of the tip (22). 22 The tip cap assembly (100) according to claim 1, which is 40% of ).

5. The tip cap assembly (100) according to claim 1, wherein the elastomer seal ring (120) comprises a thermoplastic elastomer.

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

7. Injection device (1), A container (20) having a barrel (24) and a tip (22) protruding from the end of the barrel (24), wherein the tip (22) is provided with a fluid passage (26) extending longitudinally through it, An adapter (50) positioned circumferentially at the tip (22) of the container (20), and a tip cap assembly (100) according to claim 1 connected to the adapter (50), An injection device (1) is provided with the following:

8. The injection device (1) according to claim 7, wherein the outer surface (116) of the base end 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) comprises an end portion (52) having a threaded inner surface (54), and the threaded surface (118) of the base end portion (106) of the rigid outer cap (102) is engaged with the threaded inner surface (54) of the adapter (50).

10. The injection device (1) according to claim 7, wherein the elastomer seal ring (120) of the tip cap assembly (100) is compressed radially between the rigid outer cap (102) and the adapter (50).

11. The injection device (1) according to claim 7, wherein the elastomer inner cap (130) is positioned at the tip (22) of the container (20) to seal and close the fluid passage (26).

12. The injection device (1) according to claim 7, wherein the elastomer inner cap (130) is compressed axially between a projection (140) of the rigid outer cap (102) extending radially inward and the tip (22) of the container (20) to seal and close the fluid passage (26).

13. A method for forming the tip cap assembly described in claim 1, A method comprising co-molding the seal ring (120) with the inner surface (112) of the base end portion (106) of the rigid outer cap (102).

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