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[0001] 1. Field of the Invention
[0002] The present invention relates generally to closures used in combination with specimen collection containers. More particularly, the present invention is directed to an improved closure for blood collection tubes which provides for sealed engagement with the open end of the blood collection tube and which is cost effective to manufacture.
[0003] 2. Description of Related Art
[0004] Medical specimens, such as blood samples and the like, are routinely collected and analyzed in clinical situations for various purposes. Biological materials such as blood are normally collected in a specimen collection container in the shape of an open ended tube. The tube is generally an elongate cylindrical member having one end which is open to permit access into the interior of the tube. The tube is typically provided with a removable closure in the form of a removable plastic cap or a rubber stopper which allows the contents of the tube to be transported without risk of spillage.
[0005] The art has seen various designs for closures and stoppers used in combination with blood collection tubes. One type of closure includes a relatively rigid plastic member which is inserted into the open end of the tube and which provides a seal between the closure and the inner wall of the tube about the open upper end. Closures of this type are manually inserted and removed in order to fill the tube or to remove the contents therefrom. Closures of this type are typically formed by conventional injection or compression molding processes. Such manufacturing processes result in a high quality precision part. Also, molding of plastic parts is generally an efficient method of manufacture which greatly reduces the cost of the closures.
[0006] Another type of closure which is more typically used with evacuated blood tubes is a rubber stopper. Rubber stoppers are inserted into the open end of the tube and may be formed of natural or synthetic rubber or combination thereof. These stoppers provide a resilient elastomeric seal with the inner wall of the tube. Stoppers of this type are preferred as they are easy to handle and provide a reliable seal. Materials forming such rubber stoppers may also include self-closing characteristics. This provides the closure with the ability to permit a small hole or puncture, placed in the stopper,by a hypodermic needle or trocar, to close upon itself once the needle is removed. Such self-closing characteristics allow the interior of the tube to be evacuated so that blood samples may be obtained in an evacuated fashion, as is well known in the art.
[0007] While use of rubber stoppers is preferable to rigid plastic enclosures, as the rubber stoppers provide self-sealing characteristics, are easier to insert and remove, and provide a superior seal, rubber stoppers due to their material construction are more difficult and less cost effective to manufacture. Efficient manufacturing techniques, such as injection and compression molding, may not be employed in forming such rubber stoppers. Other more complicated manufacturing techniques such as compression molding must be employed, greatly increasing the cost of the stopper. As compared with injection molding, compression molding is more time-consuming and costly. Furthermore, it is more difficult to mold complex parts with fine details by compression molding.
[0008] Accordingly, it is desirable to provide an improved tube closure which has the benefits of rubber stoppers in that the stopper is easily inserted and removed and includes self-sealing characteristics so that it may be employed with an evacuated tube, yet be manufactured efficiently and have the precision of molded plastic closures.
[0009] It is an object of the present invention to provide a closure for a specimen collection container which can be efficiently manufactured.
[0010] It is a further object of the present invention to provide a closure for a blood collection tube which sealingly engages the open end of the tube and provides self-sealing characteristics after being punctured by a trocar.
[0011] It is yet a further object of the present invention to provide a closure for a blood collection tube having the benefits of a self-sealing rubber stopper, and the precision manufacturability of a plastic closure.
[0012] In the efficient attainment of these and other objects, the present invention provides a closure for sealing the open end of a medical specimen container. The container includes a container wall defining an interior and an open end. The closure includes a molded plastic closure frame including a cap portion for positioning over the open end of the container. The closure frame includes an insertion portion depending from the cap for positioning adjacent the container wall. An elastomeric sheath is formed about the insertion portion of the frame. The elastomeric sheath is disposed in resilient frictional engagement with the container wall.
[0013] Preferably the insertion portion of the closure frame includes a plurality of a deflectable splines for resilient positioning interiorly about the container wall. The cap portion of the frame may be formed into an annular configuration having a central aperture therethrough. The splines extend circumferentially about the central aperture. The elastomeric sheath is designed to fill the central aperture of the cap portion and may be formed of a self-sealing material.
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[0025] The present invention may be described as a closure for a specimen collection container. More particularly, the present invention, in a preferred embodiment, takes the form of a closure cap assembly for a specimen collection tube.
[0026] Referring to FIGS.
[0027] Cap assembly
[0028] Referring now to FIGS.
[0029] Annular member
[0030] Insertion portion
[0031] Additionally, each proximal spline portion
[0032] Referring now to
[0033] When cap assembly
[0034] In order to access the interior
[0035] A further embodiment of the cap assembly of the present invention is shown in
[0036] As the cap assembly
[0037] Various other changes and modifications can be made to the invention, and it is intended to include all such changes and modifications as come within the scope of the invention as is set forth in the following claims.