Note: Descriptions are shown in the official language in which they were submitted.
510152025CA 02265187 1999-03-30COLLECTION ASSEMBLYThis is a divisional of Canadian Patent Application Serial No. 2,122 683ï¬led May 2, 1994.BACKGROUND OF THE INVENTION1. Field of the InventionThis invention relates to a collection assembly and more particularlyto a rnicrocollection container and cap suitable for collecting small quantitiesof blood from a patient and maintaining the blood in secure fashion forsubsequent testing.2. Description of Related ArtAnalytical instrumentation has made it possible to carry out a varietyof hematological diagnostic procedures on very small quantities of blood.Because of this, a patient's ï¬nger or earlobe, for example, may be puncturedand a very small quantity of blood may be rapidly collected into a containerfor such testing. However, in order to carry out testing and analysis on smallquantities of blood, the blood must be rapidly collected prior to anycoagulation thereof.A collection arrangement as described in U.S. Patent No. 4,397,318,has been provided wherein a cap is conï¬gured to ï¬t the top of amicrocollection container with the cap having a removable capillary scoop forengaging the puncture site and transferring blood to the container. However,with such an arrangement, if precise positioning is not carried out, capillaiyaction is not initiated or slowed and the collected blood will clot.10152025CA 02265187 1999-03-30Moreover, when a sample is taken with this collection arrangement,blood droplets may be left in and around the top area of the container. Whenthe scoop is removed from the cap and the cap is ï¬tted onto the top of thecontainer, the excess blood may be forced onto the outside surface of thecontainer.§UMMARY OF THE INVENTIONIn accordance with the invention in one aspect there is provided a capcomprising: a top portion; a bottom portion; an annular skirt extending fromsaid top portion to said bottom portion and having an inner surface and an outersurface; an inner inverted skirt portion surrounded by said inner surface of saidannular skirt and extending ï¬om said top portion toward said bottom portion;an annular space between said inner surface of said annular skirt and saidinverted skirt portion; and a cam follower positioned with said bottom portion.One embodiment described hereafter is a collection assemblycomprising a container and the cap. The cap preferably comprises a topportion, a bottom portion, andU!10152025303540CA 02265187 1999-03-30an annular skirt extending from the top portion to the bottom portion havingan inner surface and an outer surface. The cap further includes an innerinverted skirt portion surrounded by the inner surface of the annular skirt.Most preferably the inner inverted skirt portion is separated from the innersurface of the annular skirt by an annular space. Most preferably, the capalso includes a cam follower positioned on the bottom portion. Desirably, theinside surface of the annular skirt comprises at least one protrusion and theinner inverted skirt portion has a sealing ring. The cap further comprises arim extending from the outer surface of the annular skirt.The container preferably comprises an open top portion, a closedbottom portion, a sidewall extending from the top portion to the bottomportion and an open end associated with the top portion having an integralcollector. Most preferably the integral collector is a scoop that is the samediameter as the inner diameter of the container so that no air vent is required.Preferably, the container further includes a cap seating ï¬angeassociated with the outer diameter of the top portion of the container and anextending annular skirt associated with the bottom portion. Most preferably,a reservoir is positioned within the cap seating ï¬ange and at least one lug islocated in the reservoir. Preferably, the container also includes a locking ring-23-10.2030CA 02265187 1999-03-30associated between the integral collector and the cap seating ï¬ange.Preferably, the collection assembly includes means for securing theinner surfaces of the cap to the top portion of the container by the interactionof the protrusions of the cap with the locking ring of the container and thesealing ring of the cap with the inside surface of the top portion of thecontainer. Most preferably, the collection assembly also includes means forunsecuring the cap from the container by a cam arrangement on the cap andcontainer. â This cam arrangement assists in substantially reducing ï¬uidsplatter from the container when the cap is removed from the container.In a preferred embodiment of the invention, the cam arrangementincludes at least one cam follower positioned on the bottom portion of the capand at least one cam surface positioned in the cap seating ï¬ange of thecontainer. A downwardly rotational force applied to the cap and an upwardlyforce applied to the container along the longitudinal axis, causes the camfollower and the cam surface to align and the cap to snap-seal to the containerby the interaction of the protrusions of the cap with the locking ring of thecontainer and the sealing ring of the cap with the inside surface of the topportion of the container. This action, which may cause an audible-snap, inturn seals the container by compressing the protrusions of the cap against thelocking ring of the container and the sealing ring of the cap against the insidesurface of the top portion of the container to form a nonâpermanent lock andto substantially prevent the outer surface of the top portion of the containerfrom making contacting with the inside sruface of the capâs annular skirt.The cap and container are then unsecured in a twist off manner byapplying a rotational force to the cap. Most preferably, an upward rotationalforce is applied to the cap and a downwardly force applied to the containeralong the longitudinal axis. This causes the cam follower to rise on the camsurface and in turn the cap is unsecured from the container. An importantadvantage of the present invention is that the rotational force applied to thecap can be bi-directional, that is clockwise or counter-clockwise.-3-202530CA 02265187 1999-03-30The collection assembly of the present invention is preferably used inrnicro-centrifuges. However, an extension may be secured and unsecured tothe bottom portion of the container. The extension increases the lengthdimension of the container. With the extension, the container may becompatible with standard clinical centrifuges.An advantage of the present invention is that any excess ï¬uid on theoutside surface of the integral collector is directed downwardly into the capseating ï¬ange by the inner surface of the annular skirt of the cap when adownward force is applied to the cap as the cap and container are beingsecured. Therefore, radial spray of excess ï¬uids are minimized.Another advantage of the invention is that the cap may be secured andunsecured to the bottom portion of the container. In particular, the annularspace in the cap between the annular skirt and inverted skirt allows the cap tobe removably secured with the bottom portion of the container by receivingthe annular skirt of the container.0Still another advantage of the invention is that the recessed invertedskirt and the sealingâring substantially reduces cap contact with ï¬uidcollected in the container. Therefore the inner surfaces of the cap may beminimally exposed to ï¬uid collected in the container when the cap is securedto the top portion of the container.Another advantage of the present invention is that the outer surface ofthe cap may preferably be conï¬gured to substantially limit movement orrolling of the cap or the assembly. This applies whether the cap is positionedwith the top portion or bottom portion of the container.Still another advantage of the present invention is that when the cap issecured to the container, the rim of the cap substantially preventscontamination to the specimen inside the container.-4-CA 02265187 1999-03-30DESCRIPTION OF THE DRAWINGSFIG. 1 is a perspective view of the preferred collection assemblyillustrating the container with the cap unsecured.FIG. 2 is a side elevational View of the container of FIG.l, partially insection of the cam surface area.FIG. 3 is an enlarged cross sectional View of the cap of FIG. 1, takenalong line 3-3â thereof.FIG. 4 is a bottom view of the cap of FIG. 1.FIG. 5 is a side elevational view, partially in section of the collectionassembly of FIG. 1 with the cap secured to the top portion of the container.FIG. 6 is a side elevational view, partially in section of the collectionassembly of FIG. 1 with the cap removably secured to the bottom portion ofthe container.FIG. 7 is a perspective view of the preferred collection assembly ofFIG. 1 and an optional extension that may be removably secured to thecollection assembly.FIG. 8 is a side elevational view, partially in section of the collectionassembly of FIG. 7 with an extension removably secured to the bottomportion of the container.10152030CA 02265187 1999-03-30DETAILED DESCRIPTIONReferring to the drawings in which like reference characters refer tolike parts throughout the several views thereof, FIG. 1 illustrates a collectionassembly 10 comprising a container 12 and a cap 14.As illustrated in FIG. 1, container 12 has a sidewall 22 having anouter surface 24 and an inner surface 26. The sidewall extends ï¬om an upperportion 28 to a lower portion 30. Upper portion 28 includes an open end 31and an inner surface 27 with a top surface 32 having an integral lip portion 34with a receiving edge 36. Lower portion 30 comprises a closed bottom end38 and an annular skirt 37 extending ï¬om the closed bottom end and outersurface 24 to deï¬ne a compartment area 39. Annular skirt 37 provides ameans for allowing the container to be placed upright on a ï¬at surface.Upper portion 28 has a cap seating ï¬ange 40 positioned around theouter surface of the container which deï¬nes a well or trough 42 and an outersurface 41. The cap seating ï¬ange has an upper stuface edge 43 and aplurality of lugs 44 each having a cam surface 46. Although a containerhaving only one projecting lug is within the purview of the instant invention, aplurality of lugs is preferred. Also, although other shapes and conï¬gurationsare within the purview of the instant invention, lugs 44 of this embodiment aretriangularly shaped.As shown in FIG. 2, ï¬irther positioned on the outer siuface of thecontainer on the upper portion is a locking ring 48 positioned betweenreceiving edge 36 of integral lip portion 34 and cap seating ï¬ange 40. Thelocking ring has an upper edge 50 and a lower edge 52.Cap 14 as shown in FIG. 3, has a top surface 54, a bottom stop ledge56 and an annular outer skirt 58 extending from the top surface to the bottomstop ledge. The annular outer skirt has an outer wall surface 60 and an inner-5-2030CA 02265187 1999-03-30wall surface 62. A shield 66 extends from the outer wall surface of theannular outer skirt and has an outer surface or circumference 76.As shown in FIG. 3, cap 14 also has an inner annular invertedrecessed skirt portion 64 that extends from top portion 54 to a bottom surface63. The inverted recessed skirt portion deï¬nes a compartment or cup area 65- on the top portion of the cap. The inner wall surface of the annular outer skirtand the irmer annular inverted recessed skirt are spaced from each other todeï¬ne an annular space 68. The cap further includes, a plurality ofcircurnferentially spaced protrusions 70 positioned on inner wall surface 62and a sealing "ring 67 positioned on inverted recessed skirt portion 64.Projecting lugs 72 are located on bottom stop ledge 56 wherein each lugcomprises a cam follower surface 74. Although a cap having only oneprojecting lug is within the purview of the instant invention, a plurality of lugsis preferred. Also, although other shapes and conï¬gurations are within thepurview of the instant invention, lugs 72 of this embodiment are triangularlyshaped.As shown in FIG. 4, ï¬ats 77 are positioned on the outer surface ofshield 66. The ï¬ats substantially prevent the cap from rolling and provide aconvenient grasping surface for ready removal and placement of the cap onthe container. Although a shield with a smooth outer circumference withoutï¬ats is within the purview of the instant invention, a shield with an outersurface with ï¬ats is preferred.As shown in FIG. 5, when cap 14 is removably secured to container12, space 68 of the cap receives the top portion of the container including theintegral lip, protrusions 70 bear against lower edge 52 of locking ring 48 ofthe container, sealing ring 67 bears against inner surface 27 of the containerand cam follower 74 contacts carn surface 46. Shield 66 covers outer surface44 of cap seating ï¬ange 40 and bottom stop ledge 56 abuts with uppersurface edge 43 of the cap seating ï¬ange 40, so as to form a non-permanentlock and substantially prevent any excess ï¬uid in well 42 of the cap seating-7-202530CA 02265187 1999-03-30ï¬ange from spilling out. Any ï¬uid that migrates between upper surface edge43 and bottom stop ledge 56 is directed in a downward direction along thecontainer. Further, any ï¬uid in well 42 is substantially contained by the uppersurface edge of the cap seating ï¬ange and the bottom stop ledge of the cap.Cam follower surface 74 and cam surface 46 are conï¬gured so that adownwardly rotational force applied to cap 14 about longitudinal axis 80causes cam follower 74 to contact cam surface 46. Cap 14 is snapped ontothe top portion of the container as guided by carn follower surface 74 and camsurface 46. Cap 14 is removably secured to container 12 by protrusions 70and sealing ring 67 as they bear respectfully against lower edge 52 of thelocking ring and inner surface 27 of the container. The position of theprotrusions and sealing ring of the cap with the container forms space 69between the outer surface of the top portion of the container and the innerwall surface of the cap's annular outer skirt. Therefore, wiping down of anyï¬uid on the container's outer surface is substantially prevented.The cap is unsecured from the container in a twist-off manner byapplying a rotational force about longitudinal axis 80 while holding thecontainer. Rotation of the cap with respect to the container causesâ camfollower surface 74 to rise on cam surface 46 and in turn the cap is unsecuredfrom the container. The rotational force applied to the cap can be bi-directional, that is clockwise or counter-clockwise.As shown ir1 FIG. 6, cap 14 is readily compatible with skirt 37 on thelower portion of the container. Space 68 of the cap receives the skirt of thecontainer. When the cap is positioned on the bottom of the container duringï¬uid collection, the cap provides a means for allowing the container to beplaced upright on a ï¬atsurface.As shown in FIGS. 7 and 8, extension 90 is optionally available to beinserted into skirt 37 on the lower portion of container 12. The extensionmay be optionally used to make the collection assembly compatible with-3-10CA 02265187 1999-03-30standard centrifuges or the need for additional space for labeling. Multipleextensions may be used if needed.The collection assembly of the invention may be made of a clearmolded thennoplastic material so that the specimen collected may be readilyviewed. Representative materials include, for example, polyethylene,polypropylene and polyvinyl chloride. The collection container mayincorporate a hydrophilic material or a silicon may be applied to the internalsurface thereof for enhancing the ï¬ow of blood introduced into the container.Although is within the purview of the invention to provide capswhich are colored to deï¬ne speciï¬c forms of ï¬uid collection containerscontaining materials for one reason or another or for deï¬ning the kind ofexamination to be conducted on the specimen collected, transparent caps maybe provided. Also, it should be noted that the dimensions of the container aresuch as to provide space for labeling which may be important for identifyingthe collected specimens.
