Two-piece sealing cap for syringe tip

Abstract

A sealing cap for a syringe having a syringe barrel defining a reservoir for containing a drug and a distal tip having a passage for fluid communication with the reservoir, comprising a housing having an open proximal end, a closed distal end, and a side wall extending from the proximal end to the distal end and defining a cavity for receiving the distal tip, and a sealing insert covering at least a portion of the inner surface of the side wall of the housing. The material properties of the housing are different from those of the sealing insert, the inner diameter of the sealing insert is smaller than the outer diameter of at least a portion of the distal tip, and the sealing cap is fitted to cover the passage and create a seal between the sealing insert and the outer surface of the distal tip.

Description

Technical Field

[0001] The present invention relates to a two-part sealing cap that covers the tip of a syringe to prevent contaminants from contacting the tip of the syringe and / or entering the fluid passage within the tip of the syringe and / or the needle extending from the tip of the syringe, thereby eliminating the possibility of contaminating the drug contained within the syringe.

Background Art

[0002] This application claims the priority of European Patent Application No. 23170493.3, entitled "Two-Part Sealing Cap for Syringe Tip", filed on April 27, 2023, and the disclosure of the same application is incorporated herein in its entirety. This application claims the priority of European Patent Application No. 23170493.3, entitled "Two-Part Sealing Cap for Syringe Tip", filed on April 27, 2023, and the disclosure of the same application is incorporated herein in its entirety.

[0003] In the case of prefilled syringes, a cap is provided that is interference-fitted with the tip to cover the tip and / or the needle in order to prevent contamination of the syringe tip, the needle, and / or the contents of the syringe. A seal is formed between the cap and the tip. The seal is necessary for the overall container closure integrity (CCI) of the syringe assembly and contributes to it, and CCI is a measure of the overall ability of the syringe assembly to prevent the drug enclosed within the syringe from being contaminated.

[0004] The cap is usually composed of a single material and serves as the joint between the cap and the tip portion, and also plays a role in applying the contact force necessary to form a seal between the cap and the tip portion. The cap may be composed of, for example, an elastomer such as rubber or thermoplastic elastomer, or a plastic such as polypropylene (PP).

Summary of the Invention

Problems to be Solved by the Invention

[0005] The material must be soft and flexible enough to ensure a good sealing interface, and thick enough to provide the necessary contact force for sealing. Sufficient thickness of the flexible material is required to provide the necessary contact force, which increases the overall size of the cap. As a result, the diameter of the cap may exceed the diameter of the syringe barrel, thereby increasing the packaging and storage space required for the syringe assembly. Furthermore, if a single material is used for the cap, a trade-off arises between the softness and flexibility required for the sealing interface and the rigidity required to provide the necessary contact force. Therefore, a syringe sealing cap is needed that improves the seal between the syringe tip and the cap, improving the CCI of the entire syringe assembly, while simultaneously reducing the overall size of the cap. [Means for solving the problem]

[0006] The present invention relates to a sealing cap for a syringe comprising a syringe barrel defining a reservoir for containing a drug, and a distal tip having a passage for fluid communication with the reservoir. The sealing cap comprises a housing having an open proximal end, a closed distal end, and a side wall extending from the proximal end to the distal end and defining a cavity for receiving the distal tip, and a sealing insert covering at least a portion of the inner surface of the side wall of the housing. The material properties of the housing differ from those of the sealing insert, the inner diameter of the sealing insert is smaller than the outer diameter of at least a portion of the distal tip, the sealing cap covers the distal end of the passage and is configured to form a seal between the sealing insert and the outer surface of the distal tip to prevent air and contaminants from entering the cavity and / or passage of the sealing cap.

[0007] The sealing insert may extend from the proximal end to the distal end of the housing, thereby covering the entire inner surface of the side wall of the housing, or it may cover the proximal portion of the inner side wall of the housing while leaving the distal portion of the inner surface of the housing exposed. The sealing insert may also be a sleeve concentric with the side wall of the housing.

[0008] The housing material may have a higher Young's modulus, higher strength, higher hardness, and / or lower elasticity than the sealing insert material. The sealing insert can be manufactured from any polymer material that is softer than the housing and operates within the elastoplastic region of the material under the contact pressure generated at the interface, for example, within ±20% of the yield strength in the case of a polymer sealing layer. For example, the sealing insert can be made from a material selected from the group consisting of polyethylene (PE), polypropylene (PP), and elastomers including thermoplastic rubber, thermosulfurizable rubber, or thermosetting rubber. The housing can be manufactured from a material that is stiffer than the sealing insert, for example, from a material selected from the group consisting of polycarbonate (PC), polyoxymethylene (POM), polybutylene terephthalate (PBT), fiber-reinforced polymers, and metals.

[0009] The radial thickness of the sidewall of the sealing insert may be greater than the surface roughness of the outer surface of the distal tip and may be at least 20% thicker than the rms surface roughness of the outer surface of the distal tip (measured to cover a roughness scale between 2 nm and 0.1 μm).

[0010] The sealing cap provides a contact pressure of 0.1 to 50 MPa between the sealing insert and the outer surface of the distal tip, depending on the type of sealing layer implemented (compatible with elastomer to polymer types).

[0011] The radial thickness of the sidewall of the sealing insert can be minimized while being greater than the surface roughness of the outer surface of the distal tip, and the radial thickness of the sidewall of the housing can be set to a thickness that provides sufficient rigidity to generate the desired contact pressure on the outer surface of the sealing insert without significant bending deformation of the housing sidewall, and that produces the desired strength without undesirable geometric effects such as a significant increase in the outer diameter of the housing. The radial thickness of the sidewall of the housing can be set to be approximately equal to the radial thickness of a cap composed solely of the insert material that provides the contact pressure, specifically equal to the value obtained by multiplying the Young's modulus of the insert material by the contact pressure and dividing by the Young's modulus of the housing material, so that the combination of the Young's modulus of the housing material and the radial thickness of the housing sidewall provides the sealing cap with a contact force equivalent to that of a cap composed solely of the insert material.

[0012] The housing may include one or more recesses from which part or all of the radial thickness of the side wall of the housing has been removed. Any recess that completely penetrates the entire radial thickness of the side wall of the housing may be completely covered by a sealing insert. Multiple recesses may be provided on the circumference of the housing, and the material remaining between the recesses may form multiple legs extending from the proximal to the distal end of the housing.

[0013] The sealing insert may have one or more circumferential ribs extending radially inward, or the housing may have one or more circumferential ribs extending radially inward from the side walls of the housing, so that the contour of the sealing insert follows the contour of the housing.

[0014] The sealing cap may be fitted to cover the needle extending from the distal tip.

[0015] The present invention also relates to a syringe comprising a syringe barrel defining a reservoir for containing a drug, a distal tip having a passage for fluid communication with the reservoir, and a sealing cap as described above, wherein the sealing cap covers the distal end of the passage and creates a seal between the sealing insert and the outer surface of the distal tip to prevent air and contaminants from entering the sealing cap and / or the cavity of the passage.

[0016] The syringe may also be equipped with a needle extending from the distal end, and the sealing cap may be configured to cover the needle.

[0017] The outer surface of the distal tip may be substantially cylindrical or tapered, in which case the outer diameter of the proximal end of the distal tip adjacent to the distal end of the syringe barrel is greater than the outer diameter of the distal end of the distal tip. The circumferential ribs extend from the outer surface of the distal tip and contact the sealing insert. [Brief explanation of the drawing]

[0018] [Figure 1] Figure 1 is a cross-sectional view of a sealing cap placed on a syringe having a cylindrical distal tip according to the present invention. [Figure 2] Figure 2 is a cross-sectional view of a sealing cap placed on a syringe having a cylindrical distal tip and needle according to the present invention. [Figure 3] Figure 3 is a cross-sectional view of a sealing cap placed on a syringe having a tapered distal tip according to the present invention. [Figure 4] Figure 4 is a cross-sectional view of a sealing cap placed on a syringe having a tapered distal tip and needle according to the present invention. [Figure 5] Figure 5 is a cross-sectional view of the sealing cap according to the present invention. [Figure 6] Figure 6 is a cross-sectional view of an alternative sealing cap according to the present invention. [Figure 7] Figure 7 is a side view of a sealing cap with a recessed housing according to the present invention. [Figure 8]FIG. 8 is a cross-sectional view of a sealed cap including ribs extending from a sealed insert according to the present invention. [Figure 9] FIG. 9 is a cross-sectional view of a sealed cap including ribs extending from a housing according to the present invention. [Figure 10] FIG. 10 is a cross-sectional view of a sealed cap disposed at the distal tip of a syringe according to the present invention, and the distal tip of the syringe has ribs. [Figure 11] FIG. 11 is a cross-sectional view of a sealed cap in which an insert according to the present invention is provided in a recess of a housing.

BEST MODE FOR CARRYING OUT THE INVENTION

[0019] As used herein, any numerical value is expressed using a period as a decimal point and a comma as a thousands separator. For example, 1,234 is 1234 and 1.2 is 1 and 2 / 10. As used herein, unless otherwise explicitly specified, all numerical values such as those representing values, ranges, amounts or percentages can be read as if the term "about" were prefixed thereto even if the term is not explicitly shown. Any numerical range described herein is intended to include all sub-ranges subsumed therein. For example, the range "1 to 10" is intended to encompass all sub-ranges (including those greater than or equal to the minimum value 1 and less than or equal to the maximum value 10, and all sub-ranges therebetween), for example, 1 to 6.3, or 5.5 to 10, or 2.7 to 6.1. The plural includes the singular and vice versa. When ranges are specified, the endpoints of those ranges and / or the numerical values within those ranges can be combined with the scope of the present invention. The terms "comprising", "such as", "for example" and similar terms mean "including / such as / for example, but not limited to".

[0020] For the purposes described below, terms relating to spatial orientation shall relate to the direction in which the referenced embodiment is arranged, as described in the accompanying drawings, figures, or the following detailed description. However, it should be understood that the embodiments described below can envision many alternative variations and configurations. It should also be understood that the specific components, devices, features, and operating sequences described in the accompanying drawings, illustrations, or this specification are merely examples and should not be construed as limiting.

[0021] The present invention relates to a sealing cap 10 for a syringe 12 and a syringe 12 including such a sealing cap 10.

[0022] As shown in FIGS. 1 - 4, the sealing cap 10 of the present invention is adapted for use with a syringe 12 including a syringe barrel 14 having a proximal end 16, a distal end 18, and a sidewall 20 extending from the proximal end 16 to the distal end 18 and defining a reservoir 22 for containing a drug. The distal tip 24 of the syringe 12 extends from the distal end 18 of the syringe barrel 14. A fluid passage 26 extends through the distal tip 24 of the syringe 12, through which the drug is discharged from the reservoir 22.

[0023] Optionally, a needle 28 having a proximal end 30 and a pointed distal end 32 can be attached to the distal tip 24 of the syringe 12 such that the needle 28 is in fluid communication with the fluid passage 26 and / or the reservoir 22. For example, the needle 28 may be inserted through the fluid passage 26 such that the proximal end 30 of the needle 28 is disposed within the fluid passage 26, the needle 28 may be partially inserted into the fluid passage 26, or the needle 28 may be attached to the distal end 34 of the fluid passage 26.

[0024] Alternatively, the distal tip 24 of the syringe 12 may be a luer lock for connecting the syringe barrel 14 to another medical device such as a needle hub or an intravenous catheter.

[0025] The distal tip 24 of syringe 12 may have a substantially cylindrical outer surface, or the outer diameter of the distal tip 24 of syringe 112 may be tapered such that the outer diameter of the proximal end 36 of the distal tip 24 of syringe 112 adjacent to the distal end 18 of syringe barrel 14 is larger than the outer diameter of the distal end 38 of the distal tip 24 of syringe 12. The maximum outer diameter of the distal tips 24 of syringes 12 and 112 is smaller than the outer diameter of syringe barrel 14, thereby forming a distal surface 40 on the distal end 18 of syringe barrel 14.

[0026] The syringe 12 may include a plunger rod 42 having a proximal end 44, a distal end 46, a stopper 48 extending from the distal end 46, and a pressing surface 50 extending from the proximal end 44. The stopper 48 forms a seal with the side wall 20 of the syringe barrel 14 to contain the drug in the reservoir 22, and the plunger rod 42 is movable within the reservoir 22 of the syringe barrel 14 and discharges the drug from the reservoir 22 via a fluid passage 26 and / or needle 28.

[0027] The sealing cap 10 of the present invention covers the distal end 34 of the fluid passage 26 and / or the distal end 32 of the needle 28, creating a seal with the distal tip 24 of the syringe 12, thereby preventing contaminated air and contaminants from entering the distal end 34 of the fluid passage 26 and / or the distal end 32 of the needle 28.

[0028] The sealing cap 10 comprises a housing 52 having an open proximal end 54, a closed distal end 56, and a side wall 58 extending from the proximal end 54 to the distal end 56, defining a cavity 60 for receiving the distal tip 24 of the syringe 12 of the syringe barrel 14 and optionally a needle 28. The sealing insert 62 covers at least a portion of the inner surface of the side wall 58 of the housing 52. The sealing insert 62 may extend from the proximal end 54 to the distal end 56 of the housing 52, thereby covering the entire inner surface of the side wall 58 of the housing 52 (Figure 5). In another embodiment, the sealing insert 62 of the sealing cap 100 may cover only the proximal portion of the inner surface of the side wall 58 of the housing 52, leaving the distal portion of the inner surface of the housing 52 uncovered (Figure 6).

[0029] The sealing insert 62 is concentric with the inner surface of the side wall 58 of the housing 52 and can take the form of a sleeve that follows the inner surface.

[0030] The inner diameter of the sealing insert 62 is smaller than the outer diameter of at least a portion of the distal tip 24 of the sealing insert 62, so that the sealing insert 62 is compressed and / or the side wall 58 of the housing is deflected radially outward, thereby creating a friction fit and circumferential seal between the sealing insert 62 and the outer surface of the distal tip 24 of the syringe 12. For example, if the distal tip 24 of the syringe 12 is substantially cylindrical, the sealing insert 62 may have an inner diameter less than the outer diameter of the distal tip 24 of the syringe 12; if the distal tip 24 of the syringe 12 has a tapered outer surface, the sealing insert 62 may have an inner diameter less than the outer diameter of at least a portion of the distal tip 24 of the syringe 12; or if the outer surface of the distal tip 24 of the syringe 12 includes projections or ribs, the insert may have an inner diameter less than the outer diameter of the projections or ribs, or an inner diameter less than the outer diameter of the distal tip 24 of the syringe 12 in the region between the projections or ribs.

[0031] The material of the housing 52 provides the necessary compressive contact force between the sealing cap 10 and the distal tip 24 of the syringe 12, while the material of the sealing insert 62 provides a suitable soft material for creating a continuous seal and frictional fit between the sealing cap 10 and the distal tip 24 of the syringe 12.

[0032] The sealing insert 62 may be made from any suitable material that is flexible enough to compress and fit the outer surface of the distal tip 24 of the syringe 12, creating a seal between the sealing insert 62 and the outer surface of the distal tip 24 of the syringe 12, and preventing air and contaminants from entering the cavity 60 of the sealing cap 10. The material of the sealing insert 62 may be softer than the material of the housing 52 and may have a lower Young's modulus (stiffness), lower strength, lower hardness, and / or higher elasticity than the material of the housing 52. For example, the sealing insert 62 may be made from a polymer including polyethylene (PE), polypropylene (PP), elastomer, or rubber.

[0033] The housing 52 may be made from any suitable material that provides sufficient compressive contact force on the sealing insert 62 to maintain a continuous seal between the sealing insert 62 and the outer surface of the distal tip 24 of the syringe 12, thereby preventing air and contaminants from entering the cavity 60 of the sealing cap 10, and to maintain a continuous seal between the sealing insert 62 and the outer surface of the distal tip 24 of the syringe 12. The material of the housing 52 may be harder than the material of the housing 52 and may have a higher Young's modulus (stiffness), higher strength, higher hardness, and / or lower elasticity than the sealing insert 62. For example, the housing 52 may be made from polycarbonate (PC), polyoxymethylene (POM), polybutylene terephthalate (PBT), fiber-reinforced polymers, and / or metals.

[0034] The Young's modulus of the sealing insert 62 may be less than 50% of the Young's modulus of the housing 52. The Young's modulus of the sealing insert 62 may be between 0.001 and 0.1 Gpa, and the Young's modulus of the housing 52 may be between 1 and 10 Gpa.

[0035] The thickness of the sidewall 64 of the radial sealing insert 62 is greater than the surface roughness of the outer surface of the distal tip 24 of the syringe 12. The thickness of the sidewall 64 of the sealing insert 62 may be at least 20% thicker than the rms surface roughness of the outer surface of the distal tip 24 of the syringe 12 (measured to cover a roughness scale between 2 nm and 0.1 m), and may be 0.05 to 1 mm, preferably 100 μm to 0.5 mm. If the thickness is less than 0.1 mm, the thickness of the sidewall 64 of the sealing insert 62 may be too thin to compress sufficiently to form a continuous seal with the distal tip 24 of the syringe 12, and the reduction in the overall size of the sealing cap 10 is negligible. For example, for a distal tip 24 of the syringe 12 made of glass with an rms roughness in nanometric units of less than 50 to 100 nm, the sealing insert 62 may have a low thickness of 0.05 μm. For the distal tip 24 of a syringe 12 made of plastic having an RMS roughness in micrometer units of 5 to 50 μm, the sealing insert 62 may have a thickness of 7.5 to 75 μm.

[0036] The housing 52 provides a contact pressure of 0.1 to 50 MPa between the sealing insert 62 and the outer surface of the distal tip 24 of the syringe 12. Depending on the Young's modulus (rigidity) of the material of the housing 52, the radial thickness of the side wall 58 of the housing 52 may be 10 to 500 μm, preferably 50 to 200 μm, in order to provide the desired contact force.

[0037] To ensure the desired contact force while reducing the overall size of the sealing cap 10, the radial thickness of the side wall 64 of the sealing insert 62 is minimized based on the surface roughness of the outer surface of the distal tip 24 of the syringe 12, as described above. Next, the radial thickness of the side wall 58 of the housing 52 is set to a thickness that provides a desired contact pressure of 0.1 to 50 MPa between the sealing insert 62 and the outer surface of the distal tip 24 of the syringe 12, based on the Young's modulus of the housing material. A minimum contact pressure of 0.01 MPa provides sufficient frictional force between the sealing insert 62 and the outer surface of the distal tip 24 of the syringe 12 to maintain the sealing cap of the syringe 12 and provides a continuous seal between the sealing insert 62 and the outer surface of the distal tip 24 of the syringe 12, preventing air and contaminants from entering the cavity 60 of the sealing cap 10 and the distal end 34 of the fluid passage 26 and / or the distal end 32 of the needle 28. The maximum contact pressure of 50 MPa ensures that the removal force required to overcome the frictional force between the sealing insert 62 and the outer surface of the distal tip 24 of the syringe 12 when removing the sealing cap 10 from the syringe 12 is low enough to allow the sealing cap 10 to be easily and ergonomically removed from the syringe 12.

[0038] The radial thickness of the side wall 58 of the housing 52 is approximately equal to the radial thickness of the sealing cap 10, which is entirely constructed from the insert material, and this provides the desired contact pressure multiplied by the Young's modulus of the insert material divided by the Young's modulus of the housing material. For example, if the insert material is a thermoplastic elastomer with a Young's modulus of about 11 MPa, which provides the desired contact pressure with a radial thickness of 1 mm against a polypropylene (PP) housing 52 with a Young's modulus of about 1300 MPa, the desired contact force can be achieved with a radial thickness of about 0.1 mm (100 μm) of the side wall 58 of the housing 52.

[0039]

number

[0040] In the case of housing materials with a higher Young's modulus (rigidity), such as polycarbonate (PC), polyoxymethylene (POM), polybutylene terephthalate (PBT), or fiber-reinforced polymers, the ratio of the Young's modulus of the insert material to the Young's modulus of the housing material decreases proportionally, and the radial thickness of the side walls 58 of the housing 52 decreases proportionally.

[0041] The combination of the Young's modulus of the housing material and the radial thickness of the sidewall 58 of the housing 52 ensures that the sealing cap 10 has the same contact force between the inner surface (insert) of the sealing cap 10 and the outer surface of the distal tip 24 of the syringe 12, as if it were a cap made entirely of insert material. The combination of the insert material and the radial thickness of the sidewall 64 of the sealing insert 62 ensures that the sealing cap 10 has the same friction fit and seal as a cap made entirely of insert material. Furthermore, as described above, the substitution of a housing material with a higher Young's modulus for a portion of the material of the sealing cap 10 allows the overall radial thickness of the sidewall of the sealing cap 10 to be reduced compared to a sealing cap made entirely of a low Young's modulus material. Thus, the sealing cap 10 of the present invention provides sufficient contact force and sealing properties to provide a favorable friction fit and continuous seal between the sealing cap 10 and the outer surface of the distal tip 24 of the syringe 12, while reducing the overall size of the sealing cap 10 so that the total diameter of the sealing cap 10 is less than or equal to the outer diameter of the syringe barrel 14.

[0042] Any suitable shape can be used for the housing 52, as long as it provides the desired contact force to the sealing cap 400 and has an outer surface suitable for the user to grip when removing the sealing cap 10. The housing may have an axisymmetric shape about its longitudinal axis and may be substantially cylindrical, for example. As shown in Figure 7, the housing 52 may include one or more recesses 66 formed by removing part or all of the radial thickness of the side wall 58 of the housing 52. If only part of the radial thickness of the side wall 58 of the housing 52 is removed to form a recess 66, the recess 66 may be provided on the outer surface of the housing 52, the inner surface of the housing 52, or both the outer and inner surfaces of the housing 52. If the recess extends entirely through the radial thickness of the side wall 58 of the housing 52, the recess is completely covered by a sealing insert 62 to ensure that there is no opening between the outside of the sealing cap 400 and the cavity 60 of the sealing cap 400 from which air and / or contaminants can enter the cavity 60.

[0043] As an example, a plurality of recesses 66 may be provided around the housing 52 such that the material remaining between the recesses 66 is in the form of a plurality of legs 68 extending from the proximal portion of the housing 52 to the distal portion of the housing 52. Providing the recesses 66 and legs 68 may act to reduce the overall rigidity of the housing 52 while still providing the desired contact force.

[0044] The inner surface shape of the sealing insert 62 may have any shape that provides sufficient contact with the distal tip 24 of the syringe 12 in order to form a continuous seal between the sealing insert 62 and the distal tip 24 of the syringe 12 with a desired contact pressure. The inner surface shape of the sealing insert 62 may substantially correspond to the shape of the outer surface of the distal tip 24 of the syringe 12. For example, if the distal tip 24 of the syringe 12 has a substantially cylindrical outer surface, the sealing insert 62 may have a corresponding substantially cylindrical inner surface.

[0045] The sealing cap 200 (Figure 8) may have a sealing insert 62 having one or more radially inwardly extending circumferential ribs 70 that contact the outer surface of the sealing insert 62 and the distal tip 24 of the syringe 12, forming a seal between the sealing insert 62 and the outer surface of the distal tip 24. The ribs 70 may be formed entirely from the insert material. Alternatively, one or more circumferential ribs 72 may extend radially inward from the side wall 58 of the housing 52 of the sealing cap 300, and the sealing insert 62 may be configured to follow the contour of the ribs 72 of the housing 52 (Figure 9).

[0046] A circumferential rib 74 that contacts the insert and forms a continuous seal may also be provided at the distal tip 24 of the syringe 212 (Figure 10).

[0047] The sealing insert 62 can be attached to the housing 52 by any suitable connection, including, but not limited to, simultaneous injection, bonding, and deposition of the insert material onto the housing 52, or deposition of the housing material onto the sealing insert 62.

[0048] In another embodiment (Figure 11), the recess 76 may be provided on the inner surface of the side wall 58 of the housing 52 at the proximal end 54 of the housing 52, such that the sealing insert 62 is contained in the recess 76 and the distal end 78 of the sealing insert 62 rests on a distal projection 80 created at the distal end of the recess 76. The proximal end 82 of the sealing insert 62 may also be accommodated by a proximal projection 84 created at the proximal end of the recess 76. In another embodiment, a flange extending inward at the proximal end 54 of the housing 52 may contain the sealing insert 62 within the housing 52. When the proximal end 82 of the sealing insert 62 is restrained by the housing 52 via a restraining portion such as a shelf or flange, the housing 52 has an inner diameter larger than the inner diameter of the sealing insert 62, the sealing cap 500 is fully inserted into the distal tip 24 of the syringe 12, and a friction fit and seal is created between the sealing insert 62 and the outer surface of the distal tip 24 of the syringe 12 without interference caused by the restraining portion of the housing 52 in contact with the distal tip 24 of the syringe 12.

[0049] While specific embodiments of the present invention have been described above for illustrative purposes, it will be apparent to those skilled in the art that numerous modifications to the details of the present invention can be made without departing from the present invention.

Claims

1. A syringe sealing cap comprising a syringe barrel defining a reservoir for containing a drug, and a distal tip having a passage for fluid communication with the reservoir, wherein the sealing cap is A housing having an open proximal end, a closed distal end, and a side wall extending from the proximal end to the distal end and defining a cavity for receiving the distal tip, A sealing insert that covers at least a portion of the inner surface of the side wall of the housing, Equipped with, The material properties of the housing differ from those of the sealing insert. The inner diameter of the sealing insert is smaller than the outer diameter of at least a portion of the distal tip. A sealing cap for a syringe, wherein the sealing cap is fitted to cover the distal end of the passage and to create a seal between the sealing insert and the outer surface of the distal tip, thereby preventing air and contaminants from entering the sealing cap and / or the cavity of the passage.

2. The sealing cap according to claim 1, wherein the sealing insert extends from the proximal end of the housing to the distal end of the housing, thereby covering the entire inner surface of the side wall of the housing, or the sealing insert covers the proximal portion of the inner surface of the side wall of the housing but not the distal portion of the inner surface of the housing.

3. The sealing cap according to claim 1 or 2, wherein the sealing insert is a sleeve concentric with the side wall of the housing.

4. The sealing cap according to any one of claims 1 to 3, wherein the material of the housing has a higher Young's modulus, higher strength, higher hardness, and / or lower elasticity than the material of the sealing insert.

5. The sealing cap according to any one of claims 1 to 4, wherein the sealing insert is made from a material selected from the group consisting of polyethylene (PE), polypropylene (PP), elastomer, and rubber, and the housing is made from a material selected from the group consisting of polycarbonate (PC), polyoxymethylene (POM), polybutylene terephthalate (PBT), fiber-reinforced polymer, and metal.

6. The sealing cap according to any one of claims 1 to 5, wherein the radial thickness of the side wall of the sealing insert is greater than the surface roughness of the outer surface of the distal tip.

7. The sealing cap according to claim 6, wherein the radial thickness of the side wall of the sealing insert is at least 20% thicker than the surface roughness of the outer surface of the distal tip.

8. The sealing cap according to any one of claims 1 to 7, wherein the sealing cap provides a contact pressure of 0.1 to 50 MPa between the sealing insert and the outer surface of the distal tip.

9. The sealing cap according to claim 8, wherein the radial thickness of the side wall of the sealing insert is minimized to be greater than the surface roughness of the outer surface of the distal tip, and the radial thickness of the side wall of the housing is set to a thickness that provides the contact pressure.

10. The sealing cap according to claim 8, wherein the radial thickness of the side wall of the housing is approximately equal to the radial thickness of a cap entirely constructed from the insert material that provides the contact pressure multiplied by the Young's modulus of the insert material divided by the Young's modulus of the housing material, and the combination of the Young's modulus of the housing material and the radial thickness of the side wall of the housing provides the sealing cap with the same contact force as a cap entirely constructed from the insert material.

11. The sealing cap according to any one of claims 1 to 10, wherein the housing includes one or more recesses from which part or all of the radial thickness of the side wall of the housing has been removed.

12. The sealing cap according to claim 11, wherein any recess extending entirely through the radial thickness of the side wall of the housing is completely covered by the sealing insert.

13. The sealing cap according to claim 11 or 12, wherein a plurality of recesses are provided around the circumference of the housing, and the material remaining between the recesses comprises a plurality of legs extending from the proximal portion of the housing to the distal portion of the housing.

14. The sealing cap according to any one of claims 1 to 13, wherein the sealing insert has one or more circumferential ribs extending radially inward.

15. The sealing cap according to any one of claims 1 to 14, wherein the housing has one or more circumferential ribs extending radially inward from the side wall of the housing, and the contour of the sealing insert follows the contour of the housing.

16. The sealing cap according to any one of claims 1 to 15, wherein the sealing cap is fitted to cover the needle extending from the distal tip.

17. It is a syringe, A syringe barrel defining a reservoir for containing the drug, A distal tip having a passage that communicates fluidly with the reservoir, A sealing cap according to any one of claims 1 to 16, Equipped with, A syringe in which the sealing cap is fitted to cover the distal end of the passage and to create a seal between the sealing insert and the outer surface of the distal tip, thereby preventing air and contaminants from entering the sealing cap and / or the cavity of the passage.

18. The syringe according to claim 17, further comprising a needle extending from the distal tip, wherein the sealing cap is fitted to cover the needle.

19. The syringe according to claim 17 or 18, wherein the circumferential rib extends from the outer surface of the distal tip and contacts the sealing insert.

20. The syringe according to any one of claims 17 to 19, wherein the outer surface of the distal tip is substantially cylindrical.

21. The syringe according to any one of claims 17 to 19, wherein the outer surface of the distal tip is tapered such that the outer diameter of the proximal end of the distal tip adjacent to the distal end of the syringe barrel is greater than the outer diameter of the distal end of the distal tip.

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