Syringe Tip Sealing Cap

Abstract

A closure cap for a syringe includes a housing and a sealing insert received in the cavity of the housing. The housing includes a connecting portion and an insert engaging portion, and the sealing insert includes a tip engaging portion and a housing engaging portion. The housing engaging portion of the sealing insert is received in the insert engaging portion of the housing, and the tip engaging portion of the sealing insert is received in the connecting portion of the housing. The annular protrusion of the housing is received in the annular groove of the sealing insert. The annular locking rib extends around the outer periphery of the proximal end of the sealing insert and is disposed proximally beyond the proximal end of the housing. The engagement of the annular protrusion with the groove and the engagement of the housing with the locking rib retains the sealing insert in the housing. Also, a syringe includes the closure cap.

Description

[Technical Field]

[0001] The present invention is directed to a cap for covering the tip of a syringe to prevent contaminants from contacting the syringe tip and / or entering the fluid passage of the syringe tip, thereby potentially contaminating the pharmaceutical product contained within the syringe. [Background technology]

[0002] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to European Application No. 22198272.1, entitled "Sealing Cap for a Syringe Tip," filed September 28, 2022, which is incorporated herein by reference in its entirety.

[0003] Description of Related Art In prefilled syringes, prevention of contamination of the syringe tip, needle, and / or syringe contents is provided by a cap that provides 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 necessary for and contributes to the overall container closure integrity (CCI) of the syringe assembly. CCI is a measure of the syringe assembly's overall ability to prevent contamination of the pharmaceutical product contained in the syringe.

[0004] As shown in Figure 1, prior art closure cap 1 includes a sealing insert 2 that forms a seal with a syringe distal tip 24. The sealing insert 2 is enclosed in a housing 5. Upon application of closure cap 1 to a syringe, the sealing insert 2 is forced distally by the syringe distal tip 24, causing the following events to occur: (1) the upper portion 3 of the sealing insert 2 extends beyond the distal end 4 of the housing 5; (2) the projection 6 of the housing 5 and the groove 7 of the sealing insert 2 are partially or completely disengaged to retain the sealing insert 2 within the housing 5 and ensure sealing contact between the distal tip 24 of the syringe and the sealing insert 2; (3) The stopper portion 8 of the sealing insert 2, which is intended to engage and seal the fluid passageway 26 in the distal tip 24, fails to fully engage and seal with the fluid passageway 26. All of these factors adversely affect the overall seal that the sealing cap 1 provides. Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, there is a need for a closure cap that does not suffer from these defects when fitted to the distal tip of a syringe. [Means for solving the problem]

[0006] The present invention is directed to a closure cap for a syringe, the syringe including a syringe barrel defining a reservoir for containing a pharmaceutical agent and a distal tip having a passageway in fluid communication with the reservoir. The closure cap includes a housing having an open proximal end, a distal end, and a sidewall extending from the proximal end to the distal end to define a cavity, and a sealing insert received in the cavity of the housing. The housing includes a connecting portion and an insert engaging portion, and the sealing insert includes a tip engaging portion and a housing engaging portion. The housing engaging portion of the sealing insert is received in the insert engaging portion of the housing, and the tip engaging portion of the sealing insert 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 the annular groove. The annular groove is located between and connects the housing engaging portion of the sealing insert and the tip engaging portion of the sealing insert. An annular locking rib extends around the outer periphery of the proximal end of the sealing insert and is located proximally beyond the proximal end of the housing. The sealing insert is retained within the housing by engagement between the annular projection on the housing and the groove on the sealing insert, and by engagement between the proximal end of the housing and the locking rib on the sealing insert.

[0007] The tip engaging portion of the sealing insert can include an open proximal end corresponding to the proximal end of the sealing insert, a closed distal end, and a sidewall defining a cavity extending between the proximal end of the tip engaging portion of the sealing insert and the distal end of the tip engaging portion of the sealing insert, the cavity adapted and dimensioned to receive the distal end of the syringe thereby forming a seal between the inner surface of the sidewall of the tip engaging portion of the sealing insert and the outer surface of the distal tip. The stopper projection can extend from the distal end of the tip engaging portion of the sealing insert into the cavity of the tip engaging portion, and is positioned and dimensioned to contact and extend at least partially into the passageway of the distal tip.

[0008] The housing engagement portion of the sealing insert extends distally from the tip engagement portion of the sealing insert and has a distal end corresponding to the distal end of the sealing insert.

[0009] The locking rib may be spaced from the proximal end of the sealing insert such that a portion of the tip engagement portion of the sealing insert extends proximally beyond the locking rib. The locking rib may have a tapered outer periphery 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 may have a trapezoidal cross-section.

[0010] The outer diameter of the housing engagement portion of the sealing insert may be larger than the outer diameter of the tip engagement portion. The fixing rib may have an outer diameter intermediate between the outer diameter of the tip engagement portion of the sealing insert and the outer diameter of the housing engagement portion. The outer diameter of the connection portion of the housing may be smaller than the outer diameter of the insert engagement portion of the housing. The diameter of the cavity of the housing that receives the tip engagement portion of the sealing insert may be larger than the outer diameter of the tip engagement portion to provide a space between the tip engagement portion of the sealing insert and the housing. The diameter of the cavity of the housing at the annular protrusion of the housing may be approximately equal to the diameter of the sealing insert in the groove of the sealing insert.

[0011] 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.

[0012] The annular projection of the housing may extend radially inwardly around an inner circumferential surface of the side wall of the insert engaging portion of the housing.

[0013] The connecting portion of the housing extends proximally from the insert engaging portion of the housing and includes an open proximal end, an open distal end, a sidewall defining a cavity adapted to receive at least a portion of the tip engaging portion, and threads extending around an outer periphery of the sidewall of the connecting portion of the housing.

[0014] The annular protrusion of the housing may be spaced apart from the distal end of the housing by a distance approximately equal to or greater than the distance between the groove of the sealing insert and the distal end of the sealing insert, and / or the fixing rib may be spaced apart from the groove of the sealing insert by a distance approximately equal to the distance between the annular protrusion of the housing and the proximal end of the housing.

[0015] The plurality of anti-rotation ribs may extend longitudinally axially along an outer circumferential surface of the housing-engaging portion of the sealing insert, and / or the plurality of anti-rotation ribs may extend longitudinally axially along an inner circumferential 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 spaces between the anti-rotation ribs of the insert-engaging portion of the housing. The proximal ends of the anti-rotation ribs of the housing-engaging portion of the sealing insert and / or the distal ends of the anti-rotation ribs of the housing-engaging portion of the sealing insert may be tapered or pointed.

[0016] 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 an elastomeric material, 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.

[0017] The present invention is also directed to a syringe including a syringe barrel defining a reservoir for containing a medicinal product, a distal tip having a passageway in fluid communication with the reservoir, and the aforementioned sealing cap, which covers the distal end of the passageway and forms a seal between the sealing insert and an outer surface of the distal tip to prevent air and contaminants from entering the cavity of the sealing cap and / or the passageway.

[0018] The connection portion of the housing may be threadedly engaged with a luer collar. The luer collar surrounds the proximal end of the distal tip so as to receive the distal tip in the cavity of the tip engagement portion of the sealing insert. The luer collar may be a separate component that is friction-fitted onto the distal tip. The luer collar may include a proximal end adjacent the distal face of the syringe, an open distal end, and a sidewall spaced apart from the distal tip and at least partially surrounding the distal tip, the inner surface of the sidewall of the luer collar including threads that engage with threads on the outer surface of the connection portion of the housing. A plurality of radially inwardly directed mounting projections extend from the sidewall of the luer collar at the proximal end of the luer cover and are friction-fitted with the distal tip. [Brief explanation of the drawings]

[0019] [Figure 1] 1 is a cross-sectional view of a prior art closure cap attached to a syringe distal tip. [Figure 2] 1 is an exploded side perspective view of a closure cap and syringe according to the present invention. [Figure 3] 1 is a cross-sectional view of one embodiment of a closure cap according to the present invention. [Figure 4] 4 is a cross-sectional view of a sealing insert of the sealing cap of FIG. 3. [Figure 5] 4 is a cross-sectional view of the housing of the sealing cap of FIG. 3. [Figure 6] 1 is a side perspective view of one embodiment of a closure cap according to the present invention. [Figure 7] 4 is a cross-sectional view of the closure cap of FIG. 3 attached to the distal tip of a syringe having an integral luer collar. [Figure 8]4 is a cross-sectional view of the closure cap of FIG. 3 attached to the distal tip of a syringe having a separate luer collar. [Figure 9] FIG. 9 is a cross-sectional view of the lure collar of FIG. 8. DETAILED DESCRIPTION OF THE INVENTION

[0020] As used herein, all numerical values ​​are expressed using periods as decimal points and commas as thousands separators; for example, 1,234 is one thousand two hundred and thirty-four, and 1.2 is one and two-tenths. Unless expressly specified, all numerical values, such as numerical values ​​expressing numbers, ranges, amounts, and percentages, may be understood as preceded by the term "about," even if the term "about" is not explicitly stated. Numerical ranges cited herein are intended to include all subranges encompassed therein. For example, a range "1 to 10" is intended to include all subranges (inclusive) between the stated minimum value of 1 and the stated maximum value of 10, i.e., all subranges (inclusive) beginning with a minimum value of 1 or greater and ending with a maximum value of 10 or less, e.g., 1 to 6.3, or 5.5 to 10, or 2.7 to 6.1. Plurals include the singular, and vice versa. When ranges are given, the endpoints of those ranges and / or numerical values ​​within those ranges can be combined to form the scope of the invention. The terms "including," "such as," "for example," etc. mean "including but not limited to / such as but not limited to / for example, but not limited to."

[0021] For purposes of the following description, spatial orientation terms used shall refer to the referenced embodiment as oriented in the accompanying drawings, figures, or elsewhere in the detailed description below. It should be understood, however, that the embodiments described below may assume many alternative variations and configurations. It should also be understood that the specific components, devices, features, and sequences of operations illustrated in the accompanying drawings, figures, or elsewhere in this specification are merely exemplary and should not be considered limiting.

[0022] The present invention is directed to a closure cap 10 for a syringe 12 and a syringe 12 including the closure cap 10 (FIG. 2).

[0023] As shown in Figure 2, the closure cap 10 of the present invention is adapted for use with a syringe 12. The syringe 12 includes 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 medication. A distal tip 24 of the syringe 12 extends from the distal end 18 of the syringe barrel 14. A fluid passageway 26 extends through the distal tip 24 of the syringe 12. The medication may be expelled from the reservoir 22 through the fluid passageway.

[0024] The distal tip 24 of the syringe 12 may have an outer surface that is substantially cylindrical, or the distal tip 24 of the syringe 12 may be tapered such that the outer diameter of a proximal end 28 of the distal tip 24 of the syringe 12 adjacent the distal end 18 of the syringe barrel 14 is greater than the 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 surface 32 at the distal end 18 of the syringe barrel 14.

[0025] Syringe 12 may include a plunger rod 34 having a proximal end 36, a distal end 38, a stopper 40 extending from distal end 38, and a push surface 42 extending from proximal end 36. Stopper 40 forms a seal with sidewall 20 of syringe barrel 14 to contain the medication within reservoir 22. Plunger rod 34 is movable within reservoir 22 of syringe barrel 14 to expel the medication from reservoir 22 through fluid passageway 26.

[0026] The sealing cap 10 of the present invention encapsulates and seals the distal end 44 of the fluid passageway 26 and forms a seal with the distal tip 24 of the syringe 12 to prevent air and contaminants from entering the fluid passageway 26 and thereby contaminating the medication.

[0027] As shown in FIGS. 2-8, the closure cap 10 includes a closure insert 46 that is received within a housing 48 .

[0028] 4 , the sealing insert 46 has an open proximal end 50, a closed distal end 52, a tip engagement portion 54 at the proximal end 50, and a housing engagement portion 56 at the distal end 52. The tip engagement portion 54 includes an open proximal end 58 corresponding to the proximal end 50 of the sealing insert 46, a closed distal end 60, and a sidewall 62 extending between the proximal end 58 and the distal end 60 and defining a cavity 64 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 tip engagement portion 54 of the sealing insert 46 and the outer surface of the distal tip 24 of the syringe 12. A stopper projection 66 extends from the distal end 60 of the tip engagement portion 54 of the sealing insert 46 into the cavity 64 of the tip engagement portion 54 of the sealing insert 46. The stopper projection 66 is positioned and dimensioned to contact and extend at least partially into the fluid passageway 26 of the distal tip 24 of the syringe 12 .

[0029] Housing engagement portion 56 extends distally and has a proximal end 68 and a distal end 70 that corresponds to distal end 52 of sealing insert 46 .

[0030] The tip engaging portion 54 of the sealing insert 46 is connected to the housing engaging portion 56 of the sealing insert 46 by an annular groove 72 that extends around the outer periphery of the sealing insert 46. The groove 72 defines a distal surface 74 at the distal end 60 of the tip engaging portion 54 and a proximal surface 76 at the proximal end 68 of the housing engaging portion 56. The outer diameter A of the housing engaging portion 56 of the sealing insert 46 may be greater than the outer diameter B of the tip engaging portion 54 of the sealing insert 46.

[0031] An annular locking rib 78 extends around the outer periphery of the proximal end 58 of the tip engaging portion 54 of the sealing insert 46. The locking rib 78 has an outer diameter L that is intermediate the outer diameter B of the tip engaging portion 54 of the sealing insert 46 and the outer diameter A of the housing engaging portion 56 of the sealing insert 46. The locking rib 72 may be spaced from the proximal end 50 of the sealing insert 46 such that a portion of the tip engaging portion 54 of the sealing insert 46 extends proximally beyond the locking rib 72. The locking rib 72 may have a sloped outer periphery 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 may have a trapezoidal cross-section.

[0032] 5, 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.

[0033] The insert engaging portion 90 has an open proximal end 92, a distal end 94, and a sidewall 96 extending between the proximal and distal ends 92, 94 and defining a cavity 98 adapted and dimensioned to receive the housing engaging portion 56 of the sealing insert 46. The distal end 94 of the insert engaging portion 90 may be open.

[0034] The annular projection 100 extends radially inward around the inner surface of the sidewall 96 of the insert engaging portion 90 of the housing 48. The radial length of a distal face 102 of the projection 100 is greater than the radial length of a proximal face 104 of the projection 100. The diameter D of a distal portion 106 of the cavity 98 of the insert engaging portion 90 of the housing 48, which is distal to the projection 100, is greater than the diameter E of a proximal portion 108 of the cavity 98 of the insert engaging portion 90 of the housing 48, which is proximal to the projection 100.

[0035] Optionally, the gripping protrusions 110 may extend radially outward from the outer surface of the insert engagement portion 90 of the housing 48 ( FIG. 6 ). The gripping protrusions 110 are sized and configured to facilitate a user's manual gripping of the closure cap 10 when removing the closure cap 10 from the syringe 12. For example, the gripping protrusions 110 may be a plurality of ribs.

[0036] The connecting portion 88 of the housing 48 extends proximally from the proximal end 92 of the insert 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 cavity 118. The diameter of the cavity 118 of the connecting portion 88 of the housing 48 is the same as the diameter E of the proximal portion 108 of the cavity 98 of the insert engaging portion 90 of the housing 48. Threads 120 engageable with threads of a luer collar 122 surrounding the distal tip 24 of the syringe 12 extend around the outer periphery of the sidewall 116 of the connecting portion 88 of the housing 48.

[0037] 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 .

[0038] 3, 7, and 8, the housing engagement portion 56 of the sealing 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 tip engagement portion 54 of the sealing 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 within the annular groove 72 of the sealing insert 46. The locking rib 78 of the sealing insert 46 and the proximal end 50 of the sealing insert 46 extend beyond the proximal end 84 of the housing 48, with the locking rib 78 of the sealing insert 46 engaging the proximal end 84 of the housing 48.

[0039] The diameter E of the proximal portion 108 of the cavity 98 of the insert engaging portion 90 of the housing 48 and the cavity 118 of the connecting portion 88 of the housing 48 are equal, and the diameter E is larger than the outer diameter B of the tip engaging portion 54 of the sealing insert 46, providing a space between the sealing insert 46 and the housing 48 that allows the tip engaging portion 54 of the sealing insert 46 to expand when the sealing cap 10 is placed on the distal tip 24 of the syringe 12.

[0040] The projection 100 of the housing 48 is spaced from the distal end 86 of the housing 48 by a distance J, which is approximately equal to or greater than the distance K between the groove 72 in the sealing insert 46 and the distal end 52 of the sealing insert 46. The diameter F of the opening of the cavity 98 of the housing 48 at the projection 100 is approximately equal to the diameter G of the sealing insert 46 within the groove 72. As described below, the distal portion of the projection 100 of the housing 48 may be chamfered to facilitate flexing of the sealing insert 46 during assembly of the closure cap 10.

[0041] The locking rib 78 of the sealing insert 46 is spaced from the groove 72 of the sealing insert 46 by a distance H, which is approximately equal to the distance I between the projection 100 of the housing 48 and the proximal end 84 of the housing 48 .

[0042] Optionally, the side wall 96 of the insert engagement portion 90 may include an opening (not shown) that allows the housing engagement portion 56 of the sealing insert 46 to expand 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.

[0043] Optionally, a vent opening 142 may extend through the sidewall 62 of the tip engaging portion 54 of the sealing insert 46 to reduce reduced pressure that occurs when the sealing insert 46 is removed from the distal tip 24 of the syringe 12. When the closure cap 10 is placed on the distal tip 24 of the syringe 12, the vent opening 142 is sealed by the distal tip 24. When the closure cap 10 is removed from the syringe 12 and the portion of the sealing insert 46 including the vent opening 142 loses contact with the distal tip 24, the vent opening 142 allows air to enter the cavity 64 of the tip engaging portion 54 of the closure cap 10, minimizing reduced pressure that may occur when the closure cap 10 is further removed from the syringe 12.

[0044] As shown in Figure 1, prior art closure cap 1 includes a sealing insert 2 that forms a seal with the distal tip 24 of a syringe. The sealing insert 2 is enclosed in a housing 5. When closure cap 1 is attached to a syringe, the following events occur: (1) the sealing insert 2 is pushed distally by the distal tip 24 of the syringe so that the upper portion 3 of the sealing insert 2 extends beyond the distal end 4 of the housing 5; (2) the engagement between the projection 6 of the housing 5 and the groove 7 of the sealing insert 2, which is intended to retain the sealing insert 2 inside the housing 5 and ensure sealing contact of the sealing insert 2 with the distal tip 24 of the syringe, is partially or completely disengaged; (3) The stopper portion 8 of the sealing insert 7, which is intended to engage and seal the fluid passageway 26 in the distal tip 24, fails to fully engage and seal with the fluid passageway 26. All of these factors adversely affect the overall seal that the sealing cap 1 provides.

[0045] The closure cap 10 of the present invention corrects the deficiencies present in the prior art closure cap 1. The combination of the engagement between the projection 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, act to retain the sealing insert 46 within the housing 48 during placement of the closure cap 10 on the distal tip 24 of the syringe 12, ensuring a good seal between the sealing insert 46 of the closure cap 10 and the distal tip 24 of the syringe 12. The fixing rib 78 prevents the sealing insert 46 from being pushed distally by the distal tip 24 of the syringe 12, thereby preventing the insert engagement portion 90 of the sealing insert 46 from extending beyond the distal end 86 of the housing 48, causing the protrusion 100 of the housing 48 to engage with the groove 72 of the sealing insert 46 and the stopper protrusion 66 of the sealing insert 46 to fully engage with the fluid passage 26 of the distal tip 24 of the syringe 12, thereby sealing the fluid passage 26.

[0046] Optionally, a plurality of anti-rotation ribs 124 may extend longitudinally axially along the outer circumferential surface of the housing-engaging portion 56 of the sealing insert 46, and / or a plurality of anti-rotation ribs 126 may extend longitudinally axially along the inner circumferential surface of the insert-engaging portion 90 of the housing 48 (FIGS. 2, 4, and 5). The anti-rotation ribs 124 of the sealing insert 46 may be received in spaces between the anti-rotation ribs 126 of the housing 48 to prevent rotation of the sealing insert 46 within the housing 48. The anti-rotation ribs 124 of the sealing insert 46 and / or the anti-rotation ribs 126 of the housing 48 may be equally spaced around the peripheral surface of the housing-engaging portion 56 of the sealing 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 may be spaced apart by approximately 45° around their respective peripheral surfaces. The distal end 128 of the anti-rotation rib 126 of the housing 48 and / or the proximal end 130 of the anti-rotation rib 124 of the sealing insert 46 may be tapered or pointed to urge the anti-rotation rib 124 of the sealing insert 46 into the space between the anti-rotation ribs 126 of the housing 48 during assembly of the sealing cap 10.

[0047] The sealing cap 10 is assembled by inserting the proximal end 50 of the sealing insert 46 into the distal end 86 of the housing 48 and biasing the sealing insert 46 proximally. The tip engagement portion 54 of the sealing insert 46 engages the protrusion 100 of the housing 48 and is biased radially inward. As the sealing insert 46 continues to move proximally, the sealing insert 46 is further biased radially inward until the locking rib contacts the protrusion 100 of the housing 48 and the locking rib 78 passes the protrusion 100 of the housing 48. The sloped outer peripheral surface of the locking rib 78 assists in the deflection of the sealing insert 46 and in allowing the locking rib 78 to pass the protrusion 100 of the housing 48. After sufficient proximal movement of the sealing insert 46 relative to the housing 48, the optional anti-rotation rib 124 of the sealing insert 46 engages the anti-rotation rib 126 of the housing 48. The pointed or tapered ends of the anti-rotation ribs 124, 126 cause a slight rotation of the sealing insert 46, further sealingly inserting the sealing insert 46 into the housing 48 with the anti-rotation ribs 124 of the sealing insert 46 aligned with and disposed between the anti-rotation ribs 126 of the housing 48. Further advancement of the sealing insert 46 into the housing 48 aligns the grooves 72 of the sealing insert 46 with the protrusions 100 of the housing 48 and extends the locking rib 78 of the sealing insert 46 beyond the proximal end 84 of the housing 48. At this point, the sealing insert 46 resiliently returns to its undeflected state, with the projections 100 on the housing 48 captured in the grooves 72 on the sealing insert 46 and the locking ribs 78 on the sealing insert 46 engaged with the proximal end 84 of the housing 48, thereby substantially preventing further axial movement between the sealing insert 46 and the housing 48. In this position, the interlocking anti-rotation ribs 124 on the sealing insert 46 and the anti-rotation ribs 126 on the housing 48 prevents or limits rotation of the sealing insert 46 relative to the housing 48.

[0048] 2, 7, and 8, to attach the closure cap 10 to the syringe 12, the connecting portion 88 of the housing 48 of the closure cap 10 is inserted into and threaded onto 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 within the cavity 64 of the tip engaging portion 54 of the sealing insert 46, the inner surface of the sidewall 62 of the tip engaging 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 stopper protrusion 100 of the tip engaging portion 54 of the sealing insert 46 extends into the fluid passage 26 of the distal tip 24 to seal the fluid passage 26.

[0049] The luer collar 122 may be a separate component that is friction-fit onto the distal tip 24 of the syringe 12 ( FIG. 8 ), or may be integrally molded with the distal tip 24 of the syringe 212 ( FIG. 7 ). The luer collar 122 includes a proximal end 132 that is attached to the distal face 32 of the syringe 12, an open distal end 134, and a sidewall 136 that extends from the proximal end 132 to the distal end 134. The sidewall 136 of the luer collar 122 is spaced from and at least partially surrounds the distal tip 24 of the syringe 12. The inner surface of the sidewall 136 of the luer collar 122 includes threads 138 that engage with the threads 120 of the connection portion 88 of the housing 48 of the closure cap 10. The sidewall 136 of the luer collar 122 is coaxial with the distal tip 24.

[0050] When the luer collar 122 is separate from the distal tip 24, at the proximal end 132 of the luer collar 122, a plurality of radially inwardly directed attachment projections 140 extend from the inner surface of the sidewall 136 of the luer collar 122 ( FIG. 9 ). When the proximal end 132 of the luer collar 122 is urged proximally beyond the distal tip 24 of the syringe 12, the attachment projections 140 flex slightly and friction-fit against the distal tip 24, resisting separation of the luer collar 122 from the syringe 12.

[0051] Unintentional separation of the closure cap 10 from the distal tip 24 is substantially prevented by the threaded engagement of the closure cap 10 with the luer collar 122. Furthermore, the simultaneous engagement of the closure cap 10 with the luer collar 122 and the housing 48 with the sealing insert 46 positively prevents inadvertent destruction 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 closure cap 10 to disengage the threads 120 of the closure cap 10 from the threads 138 of the luer collar 122. Engagement of the optional anti-rotation rib 124 of the housing-engaging portion 56 of the sealing insert 46 with the anti-rotation rib 126 of the insert-engaging portion of the housing 48 ensures that the sealing insert 46 rotates with the housing 48. The engagement of the projection 100 on the housing 48 with the groove 72 on the sealing insert 46 and the engagement of the locking rib 78 on the sealing insert 46 with the proximal end 84 of the housing 48 ensures that the sealing insert 46 moves axially in response to disengagement of the connecting portion 88 of the housing 48 from the luer collar 122. Additionally, the locking rib 78 on the sealing insert 46 inhibits and prevents the sealing insert from rolling and / or displacement during assembly, loading onto and / or removal from the syringe 12.

[0052] The sealing insert 46 can be made from any suitable material that is flexible enough to compress and conform to the outer surface of the distal tip 24 of the syringe 12, forming a seal between the sealing insert 46 and the outer surface of the distal tip 24 of the syringe 12 to prevent air and contaminants from entering the fluid passageway 26 of the distal tip 24 of the syringe 12. For example, the sealing insert 46 may be made from polyethylene (PE), polypropylene (PP), or an elastomeric material (e.g., a rubbery material such as styrene-butadiene rubber, isoprene-bromobutyl blend, or a thermoplastic elastomer). Suitable materials are inert to the medical solution to be filled into the medical container, have sufficient heat resistance to undergo necessary sterilization procedures, and are flexible enough to grip and release the distal tip 24 of the syringe 12. The sealing insert 46 may be manufactured by a molding process, such as injection molding.

[0053] The material of housing 48 has a higher Young's modulus (stiffness), higher strength, higher hardness, and / or lower elasticity than sealing insert 46. For example, sealing insert 46 may be an elastomer having a Young's modulus of 0.0001 to 0.1 GPa, and housing 48 may be a thermoplastic material having a Young's modulus of 1 to 10 GPa.

[0054] The housing 48 may be made from any suitable material that provides sufficient compressive contact force to the sealing insert 46 to maintain a continuous seal between the sealing insert 46 and the outer surface of the distal tip 24 of the syringe 12 to prevent air and contaminants from entering the fluid passageway 26 of the distal tip 24 of the syringe 12. For example, the housing 48 may be made from a thermoplastic material, such as polycarbonate (PC), polyoxymethylene (POM), polybutylene terephthalate (PBT), polypropylene (PP), polyethylene (PE), polyvinyl chloride (PVC), polystyrene, acrylonitrile-butadiene-styrene, styrene-acrylonitrile, a fiber-reinforced polymer, a metal, or a combination thereof. The housing 48 may be made from polypropylene because it is a plastic material that is easily molded, strong, and lightweight. Additionally, polypropylene has the advantage of being highly impermeable to liquids and inert to many chemicals, which can prevent deterioration of the housing 48 when it comes into contact with medical solutions. The housing 48 may be made of a transparent material that allows for confirmation of proper assembly of the housing 48 and sealing insert 46.

[0055] While particular embodiments 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 in detail may be made therein without departing from the invention.

Claims

1. 1. A closure cap for a syringe including a syringe barrel defining a reservoir for containing a medicinal product, and a distal end having a passageway in fluid communication with the reservoir, The sealing cap: 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 cavity; a sealing insert inserted into the cavity of the housing; Including, 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 tip engagement portion of the sealing insert is received within the connecting portion of the housing; the annular projection extends radially inward from the side wall of the housing and is received in an annular groove disposed between and connecting the housing engaging portion of the sealing insert and the tip engaging portion of the sealing insert; an annular locking rib extending around the outer periphery of the proximal end of the sealing insert and disposed proximally beyond the proximal end of the housing; The sealing insert is retained within the housing by engagement between the annular projection of the housing and the groove of the sealing insert, and by engagement between the proximal end of the housing and the securing rib of the sealing insert. A sealing cap characterized by:

2. 2. The sealing cap of claim 1, wherein the tip engaging portion includes an open proximal end corresponding to the proximal end of the sealing insert, a closed distal end, and a sidewall extending between the proximal end of the tip engaging portion and the distal end of the tip engaging portion to define a cavity adapted and dimensioned to receive the distal end of the syringe, thereby forming a seal between the inner surface of the sidewall of the tip engaging portion and the outer surface of the distal tip.

3. 3. The closure cap of claim 2, wherein the stopper projection extends from the distal end of the tip engagement portion into the cavity of the tip engagement portion and is positioned and dimensioned to contact the passage of the distal tip and extend at least partially within the passage.

4. 4. The closure cap according to claim 1, wherein the housing engagement portion extends distally from the tip engagement portion of the sealing insert and has a distal end corresponding to the distal end of the sealing insert.

5. 5. The closure cap according to claim 1, wherein the securing rib is spaced from the proximal end of the sealing insert such that a portion of the tip engagement portion extends proximally beyond the securing rib.

6. 6. The closure cap according to claim 1, wherein the fixing rib has a sloped outer peripheral surface such that the outer diameter of the distal end of the fixing rib is greater than the outer diameter of the proximal end of the fixing rib.

7. 7. The closure cap according to claim 1, wherein the fixing rib has a trapezoidal cross section.

8. 8. A sealing cap according to claim 1, wherein the outer diameter of the housing engaging portion is larger than the outer diameter of the tip engaging portion, and the fixing rib has an outer diameter intermediate between the outer diameter of the tip engaging portion and the outer diameter of the housing engaging portion.

9. 9. The closure cap of claim 1, wherein the insert engaging portion has an open proximal end, a distal end, and side walls defining a cavity adapted and dimensioned to receive the housing engaging portion.

10. The sealing cap according to claim 1 , wherein the annular projection extends radially inward around an inner circumferential surface of the side wall of the insert engagement portion.

11. 11. A sealing cap as described in any one of claims 1 to 10, characterized in that the connecting portion extends proximally from the insert engaging portion and includes an open proximal end, an open distal end, and a sidewall defining a cavity adapted to receive at least a portion of the tip engaging portion, and the thread extends around an outer circumferential surface of the sidewall of the connecting portion.

12. 12. The sealing cap according to claim 1, wherein the outer diameter of the connecting portion is smaller than the outer diameter of the insert engaging portion.

13. 13. The sealing cap according to claim 1, wherein the diameter of the cavity in the housing that receives the tip engagement portion is larger than the outer diameter of the tip engagement portion, providing a space between the tip engagement portion and the housing.

14. 14. A sealing cap according to any one of claims 1 to 13, characterized in that the annular projection is spaced from the distal end of the housing by a distance approximately equal to or greater than the distance between the groove and the distal end of the sealing insert.

15. 15. The sealing cap according to any one of claims 1 to 14, wherein the diameter of the cavity in the housing at the annular projection is approximately equal to the diameter of the sealing insert in the groove.

16. 16. A closure cap according to any one of claims 1 to 15, characterized in that the fixing rib is spaced from the groove by a distance approximately equal to the distance between the annular projection and the proximal end of the housing.

17. 17. The sealing cap of claim 1, further comprising a plurality of anti-rotation ribs extending axially in the longitudinal direction along the outer peripheral surface of the housing engagement portion, and / or a plurality of anti-rotation ribs extending axially in the longitudinal direction along the inner peripheral surface of the insert engagement portion.

18. 18. The closure 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. 19. The closure cap according to claim 1, wherein the proximal end of the anti-rotation rib of the housing engagement portion and / or the distal end of the anti-rotation rib of the housing engagement portion are tapered or pointed.

20. 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, higher strength, higher hardness, and / or lower elasticity than the material of the sealing insert.

21. The sealing insert is made of a material selected from the group consisting of polyethylene (PE), polypropylene (PP), and an elastomeric material; The housing is made from 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.

21. The closure cap according to any one of claims 1 to 20, characterized in that it

22. a syringe barrel defining a reservoir for containing a medication; a distal tip having a passageway in fluid communication with the reservoir; A sealing cap according to any one of claims 1 to 21.

1. A syringe comprising: A syringe characterized in that the sealing cap encapsulates the distal end of the passageway and forms 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 passageway of the sealing cap.

23. 23. The syringe of claim 22, wherein the connecting portion is threadedly engaged with a luer collar surrounding the proximal end of the distal tip, the distal tip being received within a cavity in the tip engagement portion of the sealing insert.

24. 24. The syringe of claim 23, wherein the luer collar is a separate piece that is friction-fit onto the distal tip.

25. the luer collar includes a proximal end adjacent the distal face of the syringe, an open distal end, and a sidewall spaced from and at least partially surrounding the distal tip; the inner surface of the sidewall of the luer collar includes threads that engage with the threads on the outer surface of the fitting; At the proximal end of the luer collar, a plurality of radially inwardly directed attachment projections extend from the sidewall of the luer collar and are friction-fitted to the distal tip.

25. The syringe of claim 24.

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