Closure for a medical dispenser including a one-piece tip cap

11779520 · 2023-10-10

    Inventors

    Cpc classification

    International classification

    Abstract

    A closure assembly for a medical dispenser which may include a one-piece tip cap having a flow restrictor and a removably connected sleeve disposed in surrounding relation to the flow restrictor. The tip cap further includes an access opening and an oppositely disposed closed end, wherein the flow restrictor is structured for a fluid sealing engagement with a discharge port of the medical dispenser, passing through said access opening. The closed end includes removably attached inner and outer end segments respectively formed on the flow restrictor and the sleeve and are collectively structured to define a removable connection between the flow restrictor and sleeve. A cover may be fixedly attached to the sleeve in overlying, covering relation to exterior surfaces of the inner and outer end segments.

    Claims

    1. A closure assembly for a medical dispenser comprising: a tip cap including a flow restrictor and a sleeve disposed in surrounding relation to said flow restrictor, said flow restrictor operatively disposed in fluid sealing engagement with a discharge port of the medical dispenser, said tip cap further including an access opening and an oppositely disposed closed end, said closed end comprising an exterior surface having a flat configuration, a cover fixedly connected to said sleeve in overlying, covering relation to said exterior surface of said closed end, said closed end further comprising an inner segment formed on said flow restrictor and an outer segment, formed on said sleeve, and said inner and outer end segments removably attached to one another and collectively defining a removable connection of said flow restrictor to said sleeve.

    2. The closure assembly as recited in claim 1 wherein said flat configuration is defined by exterior surfaces of said inner and outer end of segments disposed in substantially coplanar relation to one another.

    3. The closure assembly as recited in claim 1 wherein said flow restrictor is cooperatively structured with the discharge port to establish said fluid sealing engagement by a push-force exerted on said flow restrictor, substantially independently of said push-force being exerted on said sleeve.

    4. The closure assembly as recited in claim 1 wherein said cover is fixedly connected to an exterior surface of said outer end segment, in spaced relation to an exterior surface of said inner end segment.

    5. The closure assembly as recited in claim 1 wherein said flow restrictor comprises a sealing stem operatively disposed in frictional engagement within the discharge port and in said fluid sealing engagement therewith.

    6. The closure assembly as recited in claim 2 further comprising a frangible connection disposed in removably connecting relation between said inner end segment and said outer end segment.

    7. The closure assembly as recited in claim 4 wherein said exterior surface of said inner end segment and an interior surface of said cover are disposed in a predetermined, minimally spaced relation to one another.

    8. The closure assembly as recited in claim 4 wherein said flow restrictor is cooperatively structured with the discharge port to establish said fluid sealing engagement by a push-force exerted on said flow restrictor, substantially independently of said sleeve.

    9. A closure assembly for a medical dispenser comprising: a tip cap including a flow restrictor and a sleeve disposed in surrounding relation to said flow restrictor, said flow restrictor structured for a fluid sealing engagement with a discharge port of the medical dispenser, said tip cap further including an access opening and an oppositely disposed closed end, said closed end comprising an inner end segment formed on said flow restrictor and an outer end segment, formed on said sleeve, said inner end segment and said outer end segment each including exterior surfaces disposed in substantially coplanar relation to one another, and a cover fixedly connected to said sleeve in overlying, covering relation to said exterior surface of said closed end.

    10. The closure assembly as recited in claim 9 wherein said cover is fixedly connected to an exterior surface of said outer end segment in spaced relation to an exterior surface of said inner end segment.

    11. The closure assembly as recited in claim 9 wherein said flow restrictor is cooperatively structured with the discharge port to establish said fluid sealing engagement by a push-force exerted on said flow restrictor, substantially independently of said push-force being exerted on said sleeve.

    12. The closure assembly as recited in claim 10 wherein said exterior surface of said inner end segment and an interior surface of said cover are disposed in a predetermined, minimally spaced relation to one another.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    (1) For a fuller understanding of the nature of the present invention, reference should be had to the following detailed description taken in connection with the accompanying drawings in which:

    (2) FIG. 1 is a perspective view in partial cutaway of one embodiment of the closure assembly of the present invention.

    (3) FIG. 2 is a sectional view in partial cutaway of the embodiment of FIG. 1.

    (4) FIG. 3 is a perspective view in partial cutaway of another embodiment of the closure assembly of the present invention.

    (5) FIG. 4 is a sectional view in partial cutaway of the embodiment of the closure assembly as represented in FIG. 3.

    (6) FIG. 5 is a detailed view in partial cutaway of the embodiment of FIGS. 3 and 4.

    (7) FIG. 6 is a perspective view in partial cutaway of yet another preferred embodiment of the closure assembly of the present invention.

    (8) FIG. 7 is a sectional view in perspective of the embodiment of FIG. 6.

    (9) FIG. 8 is a sectional view of the embodiment of FIGS. 6 and 7 operatively disposed in sealing engagement with a medical dispenser.

    (10) Like reference numerals refer to like parts throughout the several views of the drawings.

    DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

    (11) As represented in the accompanying drawings, the present invention is directed to a closure assembly, generally indicated as 10, and with initial reference to FIGS. 1 and 2, in one preferred embodiment is represented as being attached to a medical dispenser 100. As explained herein, the medical dispenser 100 may comprise, but is not limited to, an oral prefilled syringe.

    (12) In more specific terms, the closure assembly 10 comprises a one-piece tip cap generally indicated as 12 including a flow restrictor 14 and an outer surrounding sleeve 16, removably attached to the flow restrictor 14. The tip cap 12 includes an access opening 18 at least partially defined by the open end of the sleeve 16. In addition, the closure assembly tip cap 12 includes a closed end generally indicated as 20 comprising an inner end segment 22, integrally or otherwise connected to the flow restrictor 14 and an outer end segment 24, integrally or otherwise fixedly connected to the sleeve 16.

    (13) The removable connection between the flow restrictor 14 and the sleeve 16 is accomplished preferably, but not necessarily, by a frangible connection generally indicated as 26. The frangible connection 26 comprises at least one, but preferably a plurality of frangible tabs 28 removably interconnecting the inner and outer end segments 22 and 24. Further, the plurality of frangible tabs 28 are disposed in spaced relation to one another about the outer and inner peripheries, respectively of the inner end segment 22 and the outer end segment 24.

    (14) As represented in FIG. 2, the tip cap 12 includes a substantially elongated sealing stem 30 disposed on the interior thereof in surrounded relation to skirt 32. The sealing stem 30 is cooperatively dimensioned and configured to establish a sealing engagement 34 with the discharge port 102. Such cooperative dimensioning, between the sealing stem 30 and the discharge port 102, facilitates sliding entry of the sealing stem 30 through the terminal opening 103 and into the interior of a flow channel 104 of the nozzle 105 of the discharge port 102. Further, the sealing stem 30 may include a bulbous or enlarged diameter portion 36, which forces an enlargement of the terminal opening 103 as the bulbous portion 36 passes there through, into the interior of the flow channel 104. Also, the bulbous portion 36 facilitates the establishment of a frictional, sealing connection 34, when an installing “push-force” is exerted on the flow restrictor 14. Also, the presence and dimension of bulbous portion 36 is such as to establish a sufficient resistance to separation of the discharge port 102 from the sealing stem 30. As a result, the exertion of a “pulling-force” on the medical dispenser 100, once attached to the sealing stem 30, is enough to break the frangible connection 26 and force a removal of the flow restrictor 14 from the interior of the sleeve 16.

    (15) The aforementioned installing “push-force” is exerted on the flow restrictor 14 by a forced movement of the medical dispenser 100, as the discharge port 102 passes through the access opening 18, into the interior of the closure assembly tip cap 12. The application of the aforementioned installing “push-force” will be described in greater detail hereinafter, as it applies to both the embodiments of the closure assembly 10 as respectively represented in FIGS. 1-2 and 3-5.

    (16) Additional features of the closed end 20 of the tip cap 12 include the exterior surface 20′ having a substantially flat configuration, as represented. The flat configuration of the exterior surface of the closed end 20 is defined by the exterior surfaces 22′ and 24′ of the inner and outer end segments 22 and 24 also being flat and aligned in planar relation. Accordingly, the configuration of the flat exterior surface 20′ may comprise and be defined by an aligned planar relation and/or substantially coplanar relation of the exterior surfaces 22′ and 24′ of the inner and outer end segments 22 and 24. It is emphasized, the term “coplanar” as used herein, in regard to the alignment of the exterior surfaces 22′ and 24′ is not necessarily meant to describe a precise coplanar alignment. Rather, the term “coplanar” as used herein is meant to describe a sufficient planar alignment between the exterior surfaces 22′ and 24′, to accomplish a concurrent disposition of both the exterior surfaces 22′ and 24′ in supported engagement on a flat supporting surface, such as 300, schematically represented in FIG. 4, and explained in greater detail hereinafter.

    (17) As set forth above, the flow restrictor 14 and the sleeve 16 are removably connected by virtue of the frangible connection 26 and the plurality of frangible tabs 28 serving to interconnect the inner end segment 22 and the outer end segment 24. When a plurality of the frangible tabs 28 are utilized, they are disposed in spaced relation to one another, as indicated, possibly resulting in a plurality of elongated apertures 29 disposed therebetween. However, the apertures 29 are sufficiently small to restrict or prevent the entrance of any tool, instrument, etc. to pass there-through in an attempt to access the contents of the medical dispenser 100 by defeating the sealing engagement 34 between the flow restrictor 14 and the discharge port 102.

    (18) With reference now to FIGS. 3-5, additional protective features of the tip cap 12 may include the provision of a cover 40 being disposed in covering, overlying relation to the flat exterior surface 20’of the closed end 20. In such a protective position, the cover 40 is also disposed in overlying, covering relation to the substantially coplanar exterior surfaces 22′ and 24′ of the inner and outer end segments 22 and 24. As clearly represented in FIGS. 4 and 5, the cover 40 is fixedly secured, as at 42, to the outer end segment 24 of sleeve 16, such as by welding. Further, the cover 40 includes an interior surface 40′ which is disposed in spaced, non-engaging relation to the exterior surface 22′ of the inner end 22 of the flow restrictor 14. As such, a minimally dimensioned space 44 exists between the exterior surface 22′ of the inner end segment 22 of the flow restrictor 14 and the interior surface 40′ of the cover 40. This spacing 44 prevents an inadvertent attachment or connection between the cover 40 and the inner end segment 22, when the cover 40 is welded or otherwise fixed, as at 42, to the exterior surface 24′ of the outer end segment 24 of the sleeve 16.

    (19) As a result, the spacing 44 assures that the cover 40 is not inadvertently welded or attached directly to the flow restrictor 14, via the inner end segment 22, when the cover 40 is being welded to the exterior surface 24′. Also, the spacing 44 is minimally dimensioned to establish the distance between the inner surface 40′ and the exterior surface 22′ of the inner end segment 22 to be a preferred range of generally about 0.005 inches. This minimal distance (of generally about 0.005 inches) facilitates the establishment of the fluid sealing engagement between the discharge port 102 and the flow restrictor 22, utilizing the aforementioned inwardly or downwardly directed push-force.

    (20) As schematically represented in at least FIG. 4, the exterior surface 40″ of the cover 40, also includes a substantially flat or planar configuration. Accordingly, when the cover 40 is connected to the remainder of the tip cap 12 and the exterior surface 40″ is placed on a flat supporting surface 300, a downwardly directed, installing push-force may be exerted directly on the flow restrictor 14, as the nozzle 105 of the flow restrictor 102 passes into and through the access opening 18. Due to the minimal dimension (about 0.005 inches) of the spacing 44, the downwardly directed push-force 200 will result in a minimal displacement of the flow restrictor 14, such that the exterior surface 22′ will be temporarily deformed or displaced into supported engagement with the interior surface 40′ of the cover 40. Therefore, the minimal dimensioning of the space 44 and the temporary supported engagement of the exterior surface 22′ with the interior surface 40 will not significantly displace the plurality of frangible tabs 28 or exert a sufficient force thereon to cause their breakage. As a result, the flow restrictor 14 and the sleeve 16 will remain interconnected by the frangible connection 26, during the application of the installing “push-force” on the flow restrictor 14.

    (21) With regard to the embodiment of FIGS. 1 and 2, a similar distribution of the installing push-force 200 will occur, absent the existence of the cover 40. Moreover, when the flat exterior surface 20′ of the closed end 20 is disposed on a flat supporting surface, as at 300, both of the exterior surfaces 22′ and 24′ will be concurrently disposed in supported engagement with the supporting surface 300, due to their substantially coplanar alignment. Similar to the embodiment of FIG. 4, the application of the installing push-force 200 by the insertion of the discharge port 102 into the interior of the tip cap 12, will result in the push force 200 being primarily, if not exclusively, exerted on the flow restrictor 14. Concurrently, the exterior surface 22′ of the inner end segment 22 thereof will be supported by the supporting surface 300. Therefore, the plurality of frangible tabs 28 will not be displaced or broken during the application of the push-force 200. In turn, the frangible connection 26 will remain intact and maintain the connection between the inner and outer end segments 22 and 24 of the flow restrictor 14 and the sleeve 16.

    (22) As represented in FIGS. 6-8, yet another preferred embodiment of the present invention comprises the closure assembly 10′ having similar structural and operative features to the embodiments of FIGS. 1-5. However, the closure assembly 10′ differs somewhat structurally and operatively by being rotationally connected to the medical dispenser 100′ rather than being connected thereto by the aforementioned push-force 200.

    (23) In more specific terms, the closure assembly 10′ comprises a tip cap 12′ including a flow restrictor 14′ disposed within the interior of a sleeve 16. The flow restrictor 14′ and the sleeve 16 are removably connected to one another by means of the frangible connection 26 serving to removably interconnect the inner end segment 22 and the outer end segment 24, in the manner described above. Also, a skirt 32 is disposed in substantially surrounding relation to the flow restrictor 14′ and may serve to align the discharge port 102′ with the flow restrictor 14′. The flow restrictor 14′ differs in structure and function by being rotationally attached to the flow restrictor 102′ of the medical dispenser 100′. This is accomplished through the provision of an external thread or rib structure 15 being secured to an outermost free end of the flow restrictor 14′, disposed opposite to the inner end segment 22 thereof. As also represented, the thread or rib 15 is disposed, dimensioned and configured to rotationally engage the internal threaded surface 106 of the discharge port 102′, which surrounds the nozzle 105 thereof and when so connected established a fluid sealing engagement between the flow restrictor 14′ and the discharge port 102′.

    (24) As with the embodiments of FIGS. 1-5, an outward pulling force exerted on the medical dispenser 100′, once it is connected to the flow restrictor 14′, will result in a breakage of the frangible connection 26 and removal of the connected flow restrictor 14′ and the discharge port 102′ from the interior of the sleeve 16. However, as indicated the attachment of the flow restrictor 14′ in fluid engaging relation to the discharge port 102′ is accomplished by a rotational force being exerted on the closure assembly 10′ and/or on the medical dispenser 100′.

    (25) Therefore, the embodiment of FIGS. 6-8 further includes the provision of an attachment member 50. The attachment member 50 is not initially connected to or structured as an integral or fixed component of the closure assembly 10′. Rather, the attachment member 50 is removably connected in at least partially surrounding, rotationally driving engagement with the exterior surface 22′ and/or inner end segment 22 of the closed-end 20. The rotational, driving engagement therebetween is established, at least in part, by a ramp and cliff structure 60 including one or more first ramp and cliff sections 62 formed on and at least partially within the inner end segment 22 of the flow restrictor 14′. Further, the ramp and cliff structure 60 also includes at least one second ramp and cliff section 64 formed on the interior surface 52 of the attachment member 50. Upon engagement of the ramp and cliff sections 62 and 64 and due to the cooperative structuring thereof, a rotational driving force may be exerted on the tip cap 14′ by a forced rotation of the attachment members 50 in a single installing (clockwise) direction.

    (26) It is to be noted that because the first ramp and cliff section 62 is formed on the inner end segment 22 of the flow restrictor 14′ a rotational force applied by the attachment member 50 will only be exerted on the flow restrictor 14′ and not the sleeve 16. As a result, no breakage or disconnecting force will be exerted on the frangible connection 26, resulting in the flow restrictor 14′ and the sleeve 16 remaining in connected engagement with one another, while the rotational installing force is applied to the tip cap 12′.

    (27) Further, due to the cooperative structuring of the first and second ramp and cliff sections 62 and 64, rotation of the tip cap 12′ in the opposite, rotational direction (counter-clockwise) will be prevented. As a result, the tip cap 12′ cannot be unthreaded or rotationally disconnected from the discharge port 102′ of the medical dispenser 100′, utilizing the attachment member 50. Therefore, once the tip cap 12′ is connected to the medical dispenser 100′ by sealing engagement of the flow restrictor 14′ with the flow restrictor 102′, the tip cap 12′ cannot be unthreaded or rotationally disconnected. Access to the contents of the medical dispenser 100′ can only be obtained by exerting a pulling or rotational force on the exterior of the sleeve 16, while it remains attached to the flow restrictor 14′. Such pulling or rotational force will result in a breakage of the frangible connection 26 and a removal of the sleeve 16 from the flow restrictor 14′ and thereby provide clear evidence of attempted tampering or authorized access.

    (28) Since many modifications, variations and changes in detail can be made to the described preferred embodiment of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents.