Sealing cap for syringe tip

Abstract

A sealing cap for a syringe includes a housing and a sealing insert received within a chamber of the housing. The housing includes a connection portion and an insert engagement portion, and the sealing insert includes a tip engagement portion and a housing engagement portion. The housing engagement portion of the sealing insert is received within the insert engagement portion of the housing, and the end engagement portion of the sealing insert is received within the connection portion of the housing. An annular projection in the housing is received in an annular groove in the sealing insert. An annular locking rib extends around an outer periphery of the proximal end of the sealing insert and is positioned proximally beyond the proximal end of the housing. The engagement of the annular projection with the groove and the engagement between the housing and the locking rib retain the sealing insert within the housing. In addition, a syringe comprises the sealing cap.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to European application number 22198272.1, filed on September 28, 2022, entitled “Sealing Cap for a Syringe Tip”, the entire disclosure of which is incorporated herein by reference.

[0003] BACKGROUND OF THE INVENTION

[0004] Field of the Invention

[0005] The present invention relates to a cap that covers the tip of a syringe to prevent contaminants from contacting the tip of the syringe and / or entering a fluid passage in the tip of the syringe, thereby potentially contaminating a medicament contained in the syringe.

[0006] Description of related technologies

[0007] For prefilled syringes, contamination of the syringe tip, needle, and / or contents of the syringe is avoided by a cap that is an interference fit with the tip and covers the tip and / or needle. A seal is formed between the cap and the tip. This seal is essential to and contributes to the overall container closure integrity (CCI) of the syringe assembly, which is a measure of the overall ability of the syringe assembly to prevent contamination of the drug contained in the syringe.

[0008] As shown in FIG. 1 , the prior art sealing cap 1 includes a sealing insert 2 that forms a seal with the distal end 24 of the syringe. The sealing insert 2 is surrounded by a housing 5. During the process of setting the sealing cap 1 on the syringe, the sealing insert 2 is pushed distally by the distal end 24 of the syringe, resulting in: (1) the upper portion 3 of the sealing insert 2 extending beyond the distal end 4 of the housing 5; (2) the engagement between the protrusion 6 in the housing 5 and the groove 7 in the sealing insert 2 is intended to retain the sealing insert 2 in the housing 5 and ensure that the sealing contact between the sealing insert 2 and the distal end 24 of the syringe is partially or completely disengaged; and (3) the stopper 8 of the sealing insert 2 is intended to engage and seal the fluid channel 26 of the distal end 24, but does not fully engage and seal the fluid channel 26. All of these factors have a negative impact on the overall seal provided by the sealing cap 1.

[0009] Therefore, there is a need for a sealing cap that is not subject to these drawbacks when the sealing cap is positioned on the distal tip of a syringe. Summary of the invention

[0010] The present invention relates to a sealing cap for a syringe, the syringe comprising a syringe barrel and a distal end, the syringe barrel defining a reservoir for accommodating a drug, the distal end having a channel in fluid communication with the reservoir. The sealing cap comprises: a housing having an open proximal end, a distal end and a sidewall, the sidewall extending from the proximal end to the distal end and defining a chamber; and a sealing plug-in, the sealing plug-in being received in the chamber of the housing. The housing comprises a connecting portion and a plug-in engaging portion, and the sealing plug-in comprises a terminal engaging portion and a housing engaging portion. The housing engaging portion of the sealing plug-in is received in the plug-in engaging portion of the housing, and the terminal engaging portion of the sealing plug-in is received in the connecting portion of the housing. An annular protrusion extends radially inward from the sidewall of the housing and is received in an annular groove, the groove being positioned between the housing engaging portion of the sealing plug-in and the terminal engaging portion of the sealing plug-in and connecting the housing engaging portion of the sealing plug-in and the terminal engaging portion of the sealing plug-in. The annular locking rib extends around the outer periphery of the proximal end of the sealing insert and is positioned to proximally extend beyond the proximal end of the housing. The engagement of the annular protrusion of the housing with the groove of the sealing insert and the engagement between the proximal end of the housing and the locking rib of the sealing insert retain the sealing insert in the housing.

[0011] The end engaging portion of the sealing insert may include an open proximal end, a closed distal end, and a sidewall, the open proximal end corresponding to the proximal end of the sealing insert, the sidewall defining a chamber extending between the proximal end of the end engaging portion of the sealing insert and the distal end of the end engaging portion of the sealing insert, and the chamber is adapted and dimensioned to receive the distal end of the syringe so as to form a seal between the inner surface of the sidewall of the end engaging portion of the sealing insert and the outer surface of the distal end. A stopper protrusion may extend from the distal end of the end engaging portion of the sealing insert into the chamber of the end engaging portion and is configured and dimensioned to contact the passage of the distal end and extend at least partially into the passage of the distal end.

[0012] The housing engaging portion of the sealing insert extends in a distal direction from the tip engaging portion of the sealing insert and has a distal end corresponding to the distal end of the sealing insert.

[0013] The locking rib may be spaced from the proximal end of the sealing insert such that a portion of the distal engagement portion of the sealing insert extends proximally beyond the locking rib. The locking rib may have an outer peripheral surface that is angled such that the outer diameter of the distal end of the locking rib is greater than the outer diameter of the proximal end of the locking rib, and / or the locking rib may have a trapezoidal cross-section.

[0014] The outer diameter of the housing joint of the sealing plug-in may be greater than the outer diameter of the terminal joint. The locking rib may have an outer diameter between the outer diameter of the terminal joint and the outer diameter of the housing joint of the sealing plug-in. The outer diameter of the connecting portion of the housing may be less than the outer diameter of the plug-in joint of the housing. The diameter of the chamber of the housing that receives the terminal joint of the sealing plug-in may be greater than the outer diameter of the terminal joint, so that space is provided between the terminal joint of the sealing plug-in and the housing. The diameter of the chamber of the housing at the annular protrusion of the housing may be approximately equal to the diameter of the sealing plug-in in the groove of the sealing plug-in.

[0015] The insert engaging portion of the housing may have an open proximal end, a distal end, and a sidewall defining a cavity adapted and dimensioned to receive the housing engaging portion of the sealing insert.

[0016] The annular protrusion of the housing may extend radially inwardly around the inner surface of the side wall of the insert engagement portion of the housing.

[0017] The connecting portion of the shell extends proximally from the plug-in coupling portion of the shell and includes an open proximal end, an open distal end and a side wall, the side wall defining a chamber suitable for receiving at least a portion of the terminal coupling portion, and a thread extending around the outer peripheral surface of the side wall of the connecting portion of the shell.

[0018] The distance between the annular protrusion of the shell and the distal end of the shell can be approximately equal to or greater than the distance between the groove of the sealing plug-in and the distal end of the sealing plug-in, and / or the distance between the locking rib and the groove of the sealing plug-in can be approximately equal to the distance between the annular protrusion of the shell and the proximal end of the shell.

[0019] A plurality of anti-rotation ribs may extend axially in the longitudinal direction along the outer peripheral surface of the housing engaging portion of the sealing insert, and / or a plurality of anti-rotation ribs may extend axially in the longitudinal direction along the inner peripheral surface of the insert engaging portion of the housing. The anti-rotation ribs of the housing engaging portion of the sealing insert may be received in the space between the anti-rotation ribs of the insert engaging portion of the housing. The proximal end of the anti-rotation ribs of the housing engaging portion of the sealing insert and / or the distal end of the anti-rotation ribs of the housing engaging portion of the sealing insert may be tapered or pointed.

[0020] The material of the housing may have a higher Young's modulus, higher strength, higher hardness, and / or lower elasticity than the material of the sealing insert. The sealing insert may be made of a material selected from the group consisting of polyethylene (PE), polypropylene (PP), and elastomeric materials, and the housing may be made of a material selected from the group consisting of polycarbonate (PC), polyoxymethylene (POM), polybutylene terephthalate (PBT), polypropylene (PP), polyethylene (PE), polyvinyl chloride (PVC), polystyrene, polycarbonate, acrylonitrile-butadiene-styrene, styrene acrylonitrile, fiber reinforced polymers, metals, and combinations thereof.

[0021] The present invention also relates to a syringe comprising: a syringe barrel defining a reservoir for containing a drug; a distal tip having a channel in fluid communication with the reservoir; and a sealing cap as discussed above. The sealing cap covers the distal end of the channel and forms a seal between the sealing insert and the outer surface of the distal tip to prevent air and contaminants from entering the chamber of the sealing cap and / or the channel.

[0022] The connection portion of the housing can be threadedly engaged with a Luer collar around the proximal end of the distal end so that the distal end is received in the chamber of the end engagement portion of the sealing insert. The Luer collar can be a separate component that is frictionally fitted on the distal end. The Luer collar can include a proximal end adjacent to the distal side of the syringe, an open distal end, and a sidewall that is spaced apart from the distal end and at least partially surrounds the distal end, wherein the inner surface of the sidewall of the Luer collar includes threads that engage threads on the outer surface of the connection portion of the housing. A plurality of radially inwardly directed mounting protrusions can extend from the sidewall of the Luer collar at the proximal end of the Luer cap and frictionally engage the distal end. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] FIG1 is a cross-sectional view of a prior art sealing cap disposed on the distal end of a syringe;

[0024] Figure 2 is an exploded side perspective view of a sealing cap and a syringe according to the present invention;

[0025] Figure 3 is a cross-sectional view of an embodiment of a sealing cap according to the present invention;

[0026] Figure 4 yes Figure 3 A cross-sectional view of a sealing insert of a sealing cap;

[0027] Figure 5 yes Figure 3 A cross-sectional view of a housing of a sealing cap;

[0028] Figure 6 is a side perspective view of an embodiment of a sealing cap according to the present invention;

[0029] Figure 7 yes Figure 3 A cross-sectional view of a sealing cap disposed on the distal end of a syringe having an integral Luer ring;

[0030] Figure 8 yes Figure 3 A cross-sectional view of a sealing cap disposed at the distal end of a syringe having a separate Luer ring; and

[0031] Fig. 9 yes Figure 8 Cross-section of a Luer ring. DETAILED DESCRIPTION

[0032] As used herein, any numerical value is represented using a period as a decimal point and a comma as a thousand separator, for example, 1,234 would be one thousand two hundred and thirty-four, and 1.2 would be one plus two tenths. Unless otherwise expressly provided, all numbers, such as numbers representing values, ranges, amounts or percentages, may be understood to begin with the word "about", even if the term does not appear explicitly. Any numerical range described herein is intended to include all subranges contained therein. For example, the range of "1 to 10" is intended to include any and all subranges between the minimum value 1 described and the maximum value 10 described and includes the minimum value 1 and the maximum value 10, that is, all subranges starting with a minimum value equal to or greater than 1 and ending with a maximum value equal to or less than 10 and all subranges therebetween, for example, 1 to 6.3, or 5.5 to 10, or 2.7 to 6.1. Plural numbers include singular numbers, and vice versa. When a range is given, any endpoints of these ranges and / or numbers within these ranges may be combined with the scope of the present invention. "Including," "such as," "for example," and similar terms mean "including / such as / for example, but not limited to."

[0033] For the purpose of description, the spatial orientation terms used hereafter shall be related to the reference embodiments oriented as in the accompanying drawings, figures or otherwise in the following detailed description. However, it should be understood that the embodiments described below may adopt many optional variations and configurations. It should also be understood that the specific components, devices, features and operation sequences shown in the accompanying drawings, figures or otherwise described herein are merely exemplary and should not be considered restrictive.

[0034] The present invention relates to a sealing cap 10 for a syringe 12 and a syringe 12 ( Figure 2 ).

[0035] like Figure 2 As shown, the sealing cap 10 of the present invention is suitable for use with a syringe 12, which includes a syringe barrel 14 having a proximal end 16, a distal end 18, and a side wall 20 extending from the proximal end 16 to the distal end 18, and the side wall defines a reservoir 22 for containing a drug. The distal end 24 of the syringe 12 extends from the distal end 18 of the syringe barrel 14. A fluid channel 26 extends through the distal end 24 of the syringe 12, and the drug can be discharged from the reservoir 22 through the channel.

[0036] The distal tip 24 of the syringe 12 may have a substantially cylindrical outer surface, or the distal tip 24 of the syringe 12 may taper such that a proximal end 28 of the distal tip 24 of the syringe 12 adjacent the distal end 18 of the syringe barrel 14 has an outer diameter greater than an outer diameter of a distal end 30 of the distal tip 24 of the syringe 12. The maximum outer diameter of the distal tip 24 of the syringe 12 is less than the outer diameter of the syringe barrel 14, thereby forming a distal face 32 at the distal end 18 of the syringe barrel 14.

[0037] The syringe 12 may include a plunger rod 34 having a proximal end 36 and a distal end 38, with a stopper 40 extending from the distal end 38, and a pressing surface 42 extending from the proximal end 36. The stopper 40 forms a seal with the sidewall 20 of the syringe barrel 14 to contain the drug within the reservoir 22, and the plunger rod 34 is movable within the reservoir 22 of the syringe barrel 14 to expel the drug from the reservoir 22 through the fluid passage 26.

[0038] The sealing cap 10 of the present invention covers and seals the distal end 44 of the fluid passage 26 and forms a seal with the distal tip 24 of the syringe 12 to prevent air and contaminants from entering the fluid passage 26 and contaminating the drug.

[0039] like Figures 2 to 8 As shown, seal cap 10 includes a seal insert 46 received within a housing 48 .

[0040] like Figure 4As shown, the seal insert 46 has an open proximal end 50, a closed distal end 52, a terminal engagement portion 54 at the proximal end 50, and a housing engagement portion 56 at the distal end 52. The terminal engagement portion 54 includes an open proximal end 58 corresponding to the proximal end 50 of the seal insert 46, a closed distal end 60, and a sidewall 62 that defines a chamber 64 extending between the proximal end 58 and the distal end 60, the chamber being adapted and dimensioned to receive the distal tip 24 of the syringe 12, thereby forming a seal between the inner surface of the sidewall 62 of the terminal engagement portion 54 of the seal insert 46 and the outer surface of the distal tip 24 of the syringe 12. A stopper protrusion 66 extends from the distal end 60 of the terminal engagement portion 54 of the seal insert 46 into the chamber 64 of the terminal engagement portion 54 of the seal insert 46. The stopper protrusion 66 is configured and dimensioned to contact the fluid passage 26 of the distal tip 24 of the syringe 12 and extend at least partially into the fluid passage.

[0041] The housing engagement portion 56 extends in a distal direction and has a proximal end 68 and a distal end 70 that corresponds with the distal end 52 of the seal insert 46 .

[0042] The terminal engagement portion 54 of the seal insert 46 is connected to the housing engagement portion 56 of the seal insert 46 by an annular groove 72 that extends around the periphery of the seal insert 46. The groove 72 defines a distal side 74 at the distal end 60 of the terminal engagement portion 54 and a proximal side 76 at the proximal end 68 of the housing engagement portion 56. The outer diameter A of the housing engagement portion 56 of the seal insert 46 may be greater than the outer diameter B of the terminal engagement portion 54 of the seal insert 46.

[0043] An annular locking rib 78 extends around the outer periphery of the proximal end 58 of the terminal engagement portion 54 of the seal insert 46. The locking rib 78 has an outer diameter L that is between the outer diameter B of the terminal engagement portion 54 of the seal insert 46 and the outer diameter A of the housing engagement portion 56 of the seal insert 46. The locking rib 72 can be spaced from the proximal end 50 of the seal insert 46 such that a portion of the terminal engagement portion 54 of the seal insert 46 extends proximally beyond the locking rib 72. The locking rib 72 can have an outer peripheral surface that is angled such that the outer diameter of the distal end 74 of the locking rib 72 is greater than the outer diameter of the proximal end 76 of the locking rib 72, and the locking rib 72 can have a trapezoidal cross-section.

[0044] like Figure 5 As shown, the housing 48 includes an open proximal end 84, a distal end 86, a connecting portion 88 at the proximal end 84, and an insert engaging portion 90 at the distal end 86. The housing 48 may be substantially cylindrical. The distal end 86 of the housing 48 may be open.

[0045] Insert engaging portion 90 has an open proximal end 92, a distal end 94, and a sidewall 96 defining a chamber 98 extending therebetween and adapted and dimensioned to receive housing engaging portion 56 of sealing insert 46. Distal end 94 of insert engaging portion 90 may be open.

[0046] The annular protrusion 100 extends radially inwardly around the inner surface of the side wall 96 of the plug-in engaging portion 90 of the housing 48. The radial length of the distal side 102 of the protrusion 100 is greater than the radial length of the proximal side 104 of the protrusion 100, so that the diameter D of the distal portion 106 of the cavity 98 of the plug-in engaging portion 90 of the housing 48 distal to the protrusion 100 is greater than the diameter E of the proximal portion 108 of the cavity 98 of the plug-in engaging portion 90 of the housing 48 proximal to the protrusion 100.

[0047] Optionally, the gripping projection 110 may extend radially outward from the outer surface of the insert engaging portion 90 of the housing 48 ( Figure 6 ). The gripping protrusion 110 is sized and configured to facilitate manual gripping of the seal cap 10 by a user during removal of the seal cap 10 from the syringe 12. For example, the gripping protrusion 110 may be a plurality of ribs.

[0048] The connecting portion 88 of the housing 48 extends proximally from the proximal end 92 of the plug-engaging portion 90 of the housing 48 and includes an open proximal end 112, an open distal end 114, and a sidewall 116 extending from the proximal end 112 to the distal end 114 and defining a chamber 118. The diameter of the chamber 118 of the connecting portion 88 of the housing 48 is the same as the diameter E of the proximal portion 108 of the chamber 98 of the plug-engaging portion 90 of the housing 48. Threads 120 that are engageable with threads of a Luer collar 122 surrounding the distal tip 24 of the syringe 12 extend around the outer circumferential surface of the sidewall 116 of the connecting portion 88 of the housing 48.

[0049] The outer diameter of the connecting portion 88 of the housing 48 is smaller than the outer diameter of the insert engaging portion 90 of the housing 48 .

[0050] like Figure 3 , Figure 7 and Figure 8 As shown, the housing engagement portion 56 of the seal insert 46 is received within the distal portion 106 of the cavity 98 of the insert engagement portion 90 of the housing 48, and the terminal engagement portion 54 of the seal insert 46 is received within the proximal portion 108 of the cavity 98 of the insert engagement portion 90 of the housing 48 and the cavity 118 of the connecting portion 88 of the housing 48. The protrusion 100 of the housing 48 is received in the annular groove 72 of the seal insert 46. The locking rib 78 of the seal insert 46 and the proximal end 50 of the seal insert 46 extend beyond the proximal end 84 of the housing 48, wherein the locking rib 78 of the seal insert 46 engages with the proximal end 84 of the housing 48.

[0051] The diameter E of the proximal portion 108 of the chamber 98 of the plug-in joint 90 of the housing 48 and the diameter of the chamber 118 of the connecting portion 88 of the housing 48 are equal, and are larger than the outer diameter B of the terminal joint 54 of the sealing plug-in 46, so that when the sealing cap 10 is set on the distal end 24 of the syringe 12, a space is set between the sealing plug-in 46 and the housing 48 to allow the terminal joint 54 of the sealing plug-in 46 to expand.

[0052] The distance J between the protrusion 100 of the housing 48 and the distal end 86 of the housing 48 is approximately equal to or greater than the distance K between the groove 72 of the seal insert 46 and the distal end 52 of the seal insert 46. The diameter F of the opening of the chamber 98 of the housing 48 at the protrusion 100 is approximately equal to the diameter G of the seal insert 46 within the groove 72. The distal portion of the protrusion 100 of the housing 48 may be chamfered to facilitate deflection of the seal insert 46 during assembly of the seal cap 10, as will be discussed later.

[0053] The locking rib 78 of the seal insert 46 is spaced apart from the groove 72 of the seal insert 46 by a distance H that is approximately equal to the distance I between the protrusion 100 of the housing 48 and the proximal end 84 of the housing 48 .

[0054] The side wall 96 of the insert engagement portion 90 may optionally include an opening (not shown) that allows expansion of the housing engagement portion 56 of the sealing insert 46 during assembly of the sealing cap 10 , placement of the sealing cap 10 on the syringe 12 , and / or removal of the sealing cap 10 from the syringe 12 .

[0055] Optionally, the vent opening 142 may extend through the side wall 62 of the terminal engagement portion 54 of the seal insert 46 to reduce any vacuum that is created when the seal insert 46 is removed from the distal tip 24 of the syringe 12. When the seal cap 10 is disposed on the distal tip 24 of the syringe 12, the vent opening 142 is blocked by the distal tip 24. When the seal cap 10 is removed from the syringe 12 and the portion of the seal insert 46 containing the vent opening 142 loses contact with the distal tip 24, the vent opening 142 allows air to enter the chamber 64 of the terminal engagement portion 54 of the seal cap 10 to minimize any vacuum that may be created when the seal cap 10 is further removed from the syringe 12.

[0056] As shown in FIG. 1 , the prior art sealing cap 1 includes a sealing insert 2 that forms a seal with the distal end 24 of the syringe. The sealing insert 2 is surrounded by a housing 5. During the process of placing the sealing cap 1 on the syringe: (1) the sealing insert 2 is pushed distally by the distal end 24 of the syringe, causing the upper portion 3 of the sealing insert 2 to extend beyond the distal end 4 of the housing 5; (2) the engagement between the protrusion 6 in the housing 5 and the groove 7 in the sealing insert 2 is intended to retain the sealing insert 2 within the housing 5 and ensure that the sealing contact between the sealing insert 2 and the distal end 24 of the syringe is partially or completely disengaged; and (3) the stopper 8 of the sealing insert 7 is intended to engage and seal the fluid channel 26 of the distal end 24, but does not fully engage and seal the fluid channel 26. All of these factors have a negative impact on the overall seal provided by the sealing cap 1.

[0057] The sealing cap 10 of the present invention remedies the defects existing in the sealing cap 1 of the prior art. During the period when the sealing cap 10 is set on the distal end 24 of the syringe 12, the combination of the engagement between the protrusion 100 of the housing 48 and the groove 72 of the sealing insert 46 and the engagement between the proximal end 84 of the housing 48 and the locking rib 78 of the sealing insert 46 retains the sealing insert 46 in the housing 48 and ensures a good seal between the sealing insert 46 of the sealing cap 10 and the distal end 24 of the syringe 12. The locking rib 78 prevents the sealing insert 46 from being pushed distally by the distal end 24 of the syringe 12, thereby preventing the insert engaging portion 90 of the sealing insert 46 from extending beyond the distal end 86 of the housing 48, maintaining the engagement of the protrusion 100 of the housing 48 with the groove 72 of the sealing insert 46, and allowing the stopper protrusion 66 of the sealing insert 46 to fully engage and seal with the fluid passage 26 of the distal end 24 of the syringe 12.

[0058] Optionally, a plurality of anti-rotation ribs 124 may extend axially in the longitudinal direction along the outer peripheral surface of the housing engagement portion 56 of the seal insert 46, and / or a plurality of anti-rotation ribs 126 may extend axially in the longitudinal direction along the inner peripheral surface of the insert engagement portion 90 of the housing 48 ( Figure 2 , Figure 4 and Figure 5). In order to prevent the seal insert 46 from rotating within the housing 48, the anti-rotation ribs 124 of the seal insert 46 can be received in the space between the anti-rotation ribs 126 of the housing 48. The anti-rotation ribs 124 of the seal insert 46 and / or the anti-rotation ribs 126 of the housing 48 can be equally spaced around the peripheral surface of the housing interface 56 of the seal insert and / or the connecting portion 88 of the housing 48, respectively. For example, the anti-rotation ribs 124 and / or the anti-rotation ribs 126 can be spaced approximately 45° from each other around the corresponding peripheral surfaces. The distal ends 128 of the anti-rotation ribs 126 of the housing 48 and / or the proximal ends 130 of the anti-rotation ribs 124 of the seal insert 46 can be tapered or pointed to push the anti-rotation ribs 124 of the seal insert 46 into the space between the anti-rotation ribs 126 of the housing 48 during assembly of the seal cap 10.

[0059] The seal cap 10 is assembled by inserting the proximal end 50 of the seal insert 46 into the distal end 86 of the housing 48 and pushing the seal insert 46 in the proximal direction. The terminal engagement portion 54 of the seal insert 46 engages with the protrusion 100 of the housing 48 and deflects radially inward. As the proximal movement of the seal insert 46 continues, the locking rib contacts the protrusion 100 of the housing 48, and the seal insert 46 further deflects radially inward until the locking rib 78 has passed the protrusion 100 of the housing 48. The angled outer peripheral surface of the locking rib 78 assists in the deflection of the seal insert 46 and the locking rib 78 passing the protrusion 100 of the housing 48. After the seal insert 46 has made sufficient proximal movement relative to the housing 48, the optional anti-rotation rib 124 of the seal insert 46 engages with the anti-rotation rib 126 of the housing 48. The pointed or tapered ends of the anti-rotation ribs 124, 126 cause the seal insert 46 to rotate slightly so that the anti-rotation ribs 124 of the seal insert 46 are aligned with the anti-rotation ribs 126 of the housing 48, and the seal insert 46 can be further sealingly inserted into the housing 48, with the anti-rotation ribs 124 of the seal insert 46 positioned between the anti-rotation ribs 126 of the housing 48. The seal insert 46 is further advanced into the housing 48 so that the grooves 72 of the seal insert 46 are aligned with the protrusions 100 of the housing 48, and the locking ribs 78 of the seal insert 46 extend beyond the proximal end 84 of the housing 48. At this point, the seal insert 46 resiliently returns toward an undeflected state, with the protrusions 100 of the housing 48 sinking into the grooves 72 of the seal insert 46, and the locking ribs 78 of the seal insert 46 engage with the proximal end 84 of the housing 48 to substantially prevent further axial movement between the seal insert 46 and the housing 48. In this position, the interconnection of the anti-rotation ribs 124 of the seal insert 46 and the anti-rotation ribs 126 of the housing 48 prevents or limits rotation of the seal insert 46 relative to the housing 48 .

[0060] like Figure 2 , Figure 7 and Figure 8As shown, to attach the sealing cap 10 to the syringe 12, the connecting portion 88 of the housing 48 of the sealing cap 10 is inserted into and threadedly engaged with the Luer collar 122 that surrounds the proximal end 28 of the distal tip 24. The distal tip 24 of the syringe 12 is received in the cavity 64 of the tip engagement portion 54 of the sealing insert 46, the inner surface of the sidewall 62 of the tip engagement portion 54 of the sealing insert 46 forms a seal with at least a portion of the outer surface of the distal tip 24, and the stop protrusion 100 of the tip engagement portion 54 of the sealing insert 46 extends into and seals the fluid passage 26 of the distal tip 24.

[0061] The Luer collar 122 may be a friction fit on the syringe 12 ( Figure 8 ) on the distal tip 24 of the syringe 212, or may be integrally formed with the distal tip 24 of the syringe 212 ( Figure 7 ). The Luer collar 122 includes a proximal end 132 attached to the distal side 32 of the syringe 12, an open distal end 134, and a sidewall 136 extending from the proximal end 132 to the distal end 134. The sidewall 136 of the Luer collar 122 is spaced apart from and at least partially surrounds the distal tip 24 of the syringe 12, and the inner surface of the sidewall 136 of the Luer collar 122 includes threads 138 that engage with the threads 120 of the connecting portion 88 of the housing 48 of the sealing cap 10. The sidewall 136 of the Luer collar 122 is concentric with the distal tip 24.

[0062] If the Luer ring 122 is separated from the distal tip 24, a plurality of radially inwardly directed mounting protrusions 140 extend from the inner surface of the sidewall 136 of the Luer ring 122 at the proximal end 132 of the Luer ring 122 ( Fig. 9 When the proximal end 132 of the Luer collar 122 is pushed in the proximal direction over the distal tip 24 of the syringe 12, the mounting protrusion 140 deflects slightly and frictionally engages the distal tip 24 to prevent the Luer collar 122 from being separated from the syringe 12.

[0063] Accidental separation of the sealing cap 10 from the distal tip 24 is substantially prevented by the threaded engagement of the sealing cap 10 with the Luer collar 122. Furthermore, the threaded engagement of the sealing cap 10 with the Luer collar 122 and the simultaneous engagement of the housing 48 with the sealing insert 46 actively prevents inadvertent breaking of the seal between the sealing insert 46 and the distal tip 24. However, the distal tip 24 of the syringe 12 can be easily accessed by rotating the sealing cap 10 to disengage the threads 120 of the sealing cap 10 from the threads 138 of the Luer collar 122. The engagement of the optional anti-rotation ribs 124 of the housing engagement portion 56 of the sealing insert 46 with the anti-rotation ribs 126 of the insert engagement portion of the housing 48 ensures that the sealing insert 46 will rotate with the housing 48. The engagement of the groove 72 of the seal insert 46 with the protrusion 100 of the housing 48 and the engagement of the locking rib 78 of the seal insert 46 with the proximal end 84 of the housing 48 ensures that the seal insert 46 will move axially in response to the connection portion 88 of the housing 48 being disengaged from the Luer collar 122. Furthermore, during assembly, during placement on and / or removal from the syringe 12, the locking rib 78 of the seal insert 46 blocks and prevents the seal insert from rolling and / or shifting.

[0064] The sealing insert 46 can be made of any suitable material that is soft enough to compress and conform to the outer surface of the distal end 24 of the syringe 12 to form a seal between the sealing insert 46 and the outer surface of the distal end 24 of the syringe 12, which prevents air and contaminants from entering the fluid channel 26 of the distal end 24 of the syringe 12. For example, the sealing insert 46 can be made of polyethylene (PE), polypropylene (PP) or an elastomeric material, such as a rubber material such as styrene butadiene rubber, isoprene bromobutyl mixture or a thermoplastic elastomer. Suitable materials are inert to the drug solution to be filled into the medical container, have sufficient heat resistance to withstand the necessary sterilization procedures, and are soft enough to clamp and release the distal end 24 of the syringe 12. The sealing insert 46 can be manufactured by a molding process such as injection molding.

[0065] The material of the housing 48 has a higher Young's modulus (hardness), higher strength, higher hardness, and / or lower elasticity than the sealing insert 46. For example, the sealing insert 46 may be an elastomer having a Young's modulus of 0.0001 GPa to 0.1 GPa, and the housing 48 may be a thermoplastic having a Young's modulus of 1 GPa to 10 GPa.

[0066] The housing 48 can be made of any suitable material that provides sufficient compressive contact force on the sealing insert 46 to maintain a continuous seal between the sealing insert 46 and the outer surface of the distal end 24 of the syringe 12, which prevents air and contaminants from entering the fluid passage 26 of the distal end 24 of the syringe 12. For example, the housing 48 can be made of a thermoplastic, such as polycarbonate (PC), polyoxymethylene (POM), polybutylene terephthalate (PBT), polypropylene (PP), polyethylene (PE), polyvinylchloride (PVC), polystyrene, acrylonitrile-butadiene-styrene, styrene-acrylonitrile, fiber-reinforced polymers, metals, or a combination thereof. The housing 48 can be made of polypropylene because polypropylene is an easily moldable, strong, and lightweight plastic material. Polypropylene also has the advantages of being highly impermeable to liquids and inert relative to many chemicals, which prevents the housing 48 from degrading when in contact with a drug solution. The housing 48 may be made of a transparent material that allows verification of the proper assembly of the housing 48 and the sealing insert 46 .

[0067] While certain aspects of the present invention have been described above for purposes of illustration, it will be apparent to those skilled in the art that many changes can be made in the details of the invention without departing from the invention.

Claims

1. A sealing cap for a syringe, the syringe comprising a syringe barrel and a distal tip, the syringe barrel defining a reservoir for containing a drug, the distal tip having a channel in fluid communication with the reservoir, the sealing cap comprising: a housing having an open proximal end, a distal end, and a sidewall extending from the proximal end to the distal end and defining a chamber; as well as a sealing insert received in the chamber of the housing, wherein the housing comprises a connecting portion and a plug-in engaging portion, and the sealing plug-in comprises a terminal engaging portion and a housing engaging portion, the housing engagement portion of the sealing insert is received within the insert engagement portion of the housing, and the terminal engagement portion of the sealing insert is received within the connecting portion of the housing, an annular protrusion extending radially inwardly from the side wall of the housing and received in an annular groove, the groove being positioned between and connecting the housing engagement portion of the sealing insert and the terminal engagement portion of the sealing insert, an annular locking rib extending around an outer periphery of the proximal end of the seal insert and positioned proximally beyond the proximal end of the housing, and The engagement of the annular protrusion of the housing with the groove of the seal insert and the engagement between the proximal end of the housing and the locking rib of the seal insert retains the seal insert within the housing.

2. The sealing cap according to claim 1, wherein: The terminal joint includes an open proximal end, a closed distal end, and a side wall, wherein the open proximal end of the terminal joint corresponds to the proximal end of the sealing plug, and the side wall of the terminal joint defines a chamber, which extends between the proximal end of the terminal joint and the distal end of the terminal joint and is suitable for and sized to receive the distal end of the syringe, thereby forming a seal between the inner surface of the side wall of the terminal joint and the outer surface of the distal end.

3. The sealing cap according to claim 2, wherein: A stopper protrusion extends from the distal end of the tip engagement portion into the cavity of the tip engagement portion and is configured and dimensioned to contact and extend at least partially into the channel of the distal tip.

4. The sealing cap according to any one of claims 1 to 3, wherein: The housing engagement portion extends in a distal direction from the terminal engagement portion of the seal insert and has a distal end corresponding to the distal end of the seal insert.

5. The sealing cap according to any one of claims 1 to 4, wherein: The locking rib is spaced from the proximal end of the seal insert such that a portion of the terminal engagement portion extends proximally beyond the locking rib.

6. The sealing cap according to any one of claims 1 to 5, wherein: The locking rib has an outer peripheral surface that is angled such that an outer diameter of a distal end of the locking rib is greater than an outer diameter of a proximal end of the locking rib.

7. The sealing cap according to any one of claims 1 to 6, wherein: The locking rib has a trapezoidal cross section.

8. The sealing cap according to any one of claims 1 to 7, wherein: The outer diameter of the housing engagement portion is larger than the outer diameter of the terminal engagement portion, and the locking rib has an outer diameter between the outer diameters of the terminal engagement portion and the outer diameter of the housing engagement portion.

9. The sealing cap according to any one of claims 1 to 8, wherein: The insert engagement portion has an open proximal end, a distal end, and side walls, the side walls of the insert engagement portion defining a cavity adapted and dimensioned to receive the housing engagement portion.

10. The sealing cap according to any one of claims 1 to 9, wherein: The annular protrusion extends radially inwardly around an inner surface of the side wall of the insert engagement portion.

11. The sealing cap according to any one of claims 1 to 10, wherein: The connecting portion extends proximally from the plug-in engaging portion and includes an open proximal end, an open distal end, and a side wall, wherein the side wall of the connecting portion defines a cavity suitable for receiving at least a portion of the terminal engaging portion, and a thread extends around the outer peripheral surface of the side wall of the connecting portion.

12. The sealing cap according to any one of claims 1 to 11, wherein: The outer diameter of the connecting portion is smaller than the outer diameter of the plug-in engaging portion.

13. The sealing cap according to any one of claims 1 to 12, wherein: The cavity of the housing that receives the terminal engagement portion has a diameter that is larger than an outer diameter of the terminal engagement portion so that a space is provided between the terminal engagement portion and the housing.

14. The sealing cap according to any one of claims 1 to 13, wherein: The annular protrusion is spaced apart from the distal end of the housing by a distance that is approximately equal to or greater than a distance between the groove and the distal end of the sealing insert.

15. The sealing cap according to any one of claims 1 to 14, wherein: The diameter of the chamber of the housing at the annular protrusion is approximately equal to the diameter of the sealing insert within the groove.

16. The sealing cap according to any one of claims 1 to 15, wherein: The locking rib is spaced apart from the groove by a distance approximately equal to a distance between the annular protrusion and the proximal end of the housing.

17. The sealing cap according to any one of claims 1 to 16, further comprising a plurality of anti-rotation ribs extending axially in the longitudinal direction along the outer peripheral surface of the shell joint, and / or a plurality of anti-rotation ribs extending axially in the longitudinal direction along the inner peripheral surface of the plug-in joint.

18. The sealing cap according to any one of claims 1 to 17, wherein: The anti-rotation ribs of the housing engagement portion are received in spaces between the anti-rotation ribs of the insert engagement portion.

19. The sealing cap according to any one of claims 1 to 18, wherein: The proximal end of the anti-rotation rib of the housing engaging portion and / or the distal end of the anti-rotation rib of the housing engaging portion is tapered or pointed.

20. The sealing cap according to any one of claims 1 to 19, wherein: The material of the housing has a higher Young's modulus, a higher strength, a higher hardness, and / or a lower elasticity than the material of the sealing insert.

21. The sealing cap according to any one of claims 1 to 20, wherein: The sealing insert is made of a material selected from the group consisting of polyethylene (PE), polypropylene (PP), elastomeric material, and the shell is made of a material selected from the group consisting of polycarbonate (PC), polyoxymethylene (POM), polybutylene terephthalate (PBT), polypropylene (PP), polyethylene (PE), polyvinyl chloride (PVC), polystyrene, acrylonitrile-butadiene-styrene, styrene acrylonitrile, fiber-reinforced polymers, metals and combinations thereof.

22. A syringe, comprising: a syringe barrel defining a reservoir for containing a medicament; a distal tip having a passage in fluid communication with the reservoir; as well as The sealing cap according to claims 1 to 21, The sealing cap covers the distal end of the channel and forms a seal between the sealing insert and the outer surface of the distal tip to prevent air and contaminants from entering the chamber of the sealing cap and / or the channel.

23. The syringe of claim 22, wherein: The connecting portion is threadably engaged with a Luer collar surrounding a proximal end of the distal tip, and the distal tip is received in a cavity of the tip engagement portion of the sealing insert.

24. The syringe of claim 23, wherein: The Luer collar is a separate component that is friction fit over the distal tip.

25. The syringe of claim 24, wherein: The Luer collar includes a proximal end adjacent to the distal side of the syringe, an open distal end, and a sidewall, the sidewall of the Luer collar being spaced apart from and at least partially surrounding the distal tip, an inner surface of the sidewall of the Luer collar including threads that engage threads on an outer surface of the connecting portion, and a plurality of radially inwardly directed mounting protrusions extending from the sidewall of the Luer collar at the proximal end of the Luer collar and frictionally engaging the distal tip.

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