1. Field of the Invention
The present invention relates to a collection assembly and more particularly to a microcollection container and cap assembly suitable for collecting small quantities of a specimen such as blood from a patient, that provides access to the interior of the container without the need for removing the cap from the assembly and for maintaining a specimen in secure fashion for subsequent testing.
2. Description of Related Art
Analytical instrumentation has made it possible to carry out a variety of hemological diagnostic procedures on very small quantities of blood. The blood may be collected from a small puncture placed in a patient""s finger or ear lobe. The blood is collected in a microcollection container. Once the small quantities of blood are collected, the container is sealably covered by a cap.
In order for a laboratory technician to conduct tests on the blood sample which is collected in the container, the cap must be removed from the container so as to provide access to the blood sample. In the alternative, the entire contents of the container may be transferred from the container to an instrument compatible sample holder in order for laboratory analysis to take place.
Therefore, there is a need for a microcollection container that is (i) compatible with instruments for laboratory analysis whereby the specimen does not have to be transferred out of the container for analysis to be conducted; (ii) provides a resealable portion for easy access into the container by a needle or probe that also prevents specimen leakage out of the container; (iii) maintains a specimen in secure fashion; and (iv) prevents contamination to the specimen and to the user.
The present invention is a collection assembly comprising a container and a cap.
The container includes an open end, a closed end and a cylindrical wall therebetween which preferably comprises the interior of the container for accommodating the specimen.
Desirably, the cap comprises a cap body removably sealably secured to the open end of the container. The cap body supports a membrane for providing reseable access to the interior of the container. The membrane is formed of a material which is capable of being pierced and resealed on a repetitive basis with a needle or instrument probe. Most preferably, the membrane is formed of a thermoplastic elastomer. Such thermoplastic elastomers include isoprene propylene, such as MONOPRENE (a trademark of QST, Inc.) sold by QST, Inc., St. Albans, Vt.
Preferably, the membrane is disc-shaped having a concave surface facing away from the container interior which assists in resealing of the membrane. The thermoplastic elastomer allows for the resealing of the pierced membrane in a manner which prevents specimen leakage therethrough even when the collection assembly is held in an inverted position.
Preferably, the cap body includes a top portion, a bottom portion, a cylindrical sidewall extending from the top portion to the bottom portion having an inner surface and an outer surface, an access passageway at the top portion and a membrane supported across the passageway.
The cap body may further include a depending annular skirt extending into the interior of the container from the top portion and defining an annular region with the cylindrical sidewall. The open end of the container is accommodated within the annular region. The depending skirt includes an access passageway, with the membrane being supported across the passageway.
Preferably, the membrane and the cap body may be co-injection molded or insert molded.
An advantage of the present invention is that it facilitates direct access to a sample for diagnostic instrumentation systems and enables microcollection tube compatability with diagnostic instrumentation by providing features such as pierceability and self-resealing of the cap.
Still another advantage of the present invention is that the self-sealing pierceable cap permits mixing of the specimen in the container without transferring the specimen to another container and providing for direct access to the specimen via the self-sealing pierceable cap by diagnostic instrumentation.
Most notably, is that the present invention permits a specimen to be accessed through the top of the cap without removing the cap from the container, thereby providing minimal exposure of the specimen to the user.
In addition, the present invention permits the assembly to be directly used on instrumentation similar to that used for evacuated collection assemblies.
Advantages of the membrane of the present invention include that: (i) it can be pierced and resealed many times; (ii) it requires less than 2 lb. force for a piercing element to pierce it; and (iii) the concave shape aids in the ability of the membrane to seal properly after the piercing element is removed.
USPTO Backgrounds
USPTO Backgrounds