Bodily fluid test kit and method of testing bodily fluids

Claim 1

A kit for collecting and testing bodily fluids, the kit comprising: a disposable container including a tubular member having an upper end portion and a lower end portion, a valve sealably attached to the lower end portion of the tubular, member, a closure means attached to the upper end of the tubular member that is further characterized as including two overlapping opposing flaps attached to the upper end of the tubular member, each flap folding inward, one on top of the other, to substantially close the upper end of the tubular member, a collection bag, the bag including an upper portion that is sealably attached to an outer surface of the tubular member and a lower portion for collecting fluid, the lower portion of the collection bag including an injection site for removing samples of fluid from the collection bag, the injection site is further characterized as being an injection tube that sealably passes through the lower end of the collection bag, the injection tube accommodating a membrane, the membrane sealing the injection tube and preventing leakage of fluid through the injection tube, the membrane capable of being punctured by the syringe during removal of a sample from the collection bag, the membrane further being sufficiently resilient so that the membrane is resealed upon the withdrawal of the syringe from the membrane, the injection tube of the injection site also includes a removable cap to protect the membrane prior to the removal of a sample, a sleeve including a first open end portion and a second open end portion, the first open end portion being sealably attached to the outer surface of the tubular member between an upper end of the tubular member and the upper portion of the collection bag, the second open end portion of the sleeve folding upward over the upper end of the tubular member and being sealable, the upper portion of the collection bag, the valve and the second open end of the sleeve combining to provide substantial containment of fluid within the disposable container after fluid is disposed therein; means for withdrawing a sample of fluid through the injection site, said means for withdrawing a sample of fluid through the injection site further characterized as including a test tube for receiving the fluid sample that is passed through the syringe, a test-tube-holding-sleeve having a closed end and an open end, the syringe is sealably attached to a closed end of a test tube-holding sleeve, the open end of the test-tube-holding-sleeve receiving the test tube.

Claim 3

A method of collecting a bodily fluid and retrieving a test sample of the bodily fluid, the method comprising the following steps: a. depositing the bodily fluid into a disposable container, the disposable container comprising a tubular member having an upper end portion and a lower end portion, valve means sealably attached to the lower end portion of the tubular member, a collection bag, the bag including an upper portion that is sealably attached to an outer surface of the tubular member and a lower portion for collecting fluid, the lower portion of the collection bag including an injection site for removing samples of fluid from the collection bag, a sleeve including a first open end portion and a second open end portion, the first open end portion being sealably attached to the outer surface of the tubular member, the second open end portion of the sleeve folding upward over the upper end of the tubular member and being sealable, the upper portion of the collection bag, which is sealably attached to the tubular member, in combination with the valve means and the second open end portion of the sleeve providing substantial containment of fluid within the disposable container after fluid is disposed therein; b. folding the second open end portion of the sleeve upward over the conically-shaped tubular member and sealing the second open end portion of the sleeve; c. injecting a first end of a double-end syringe into the injection site; and d. inserting a vacuumed test-tube over a second end of the syringe to create a pressure drop across the syringe thereby withdrawing a sample of the bodily fluid through the syringe and into a test tube.

Claim 4

A method of collecting a bodily fluid and retrieving a test sample of the bodily fluid, the method comprising the following steps: a. depositing the bodily fluid into a disposable container, the disposable container comprising a tubular member having an upper end portion and a lower end portion, valve means sealably attached to the lower end portion of the tubular member, a collection bag, the bag including an upper portion that is sealably attached to an outer surface of the tubular member and a lower portion for collecting fluid, the lower portion of the collection bag including an injection site for removing samples of fluid from the collection bag, a sleeve including a first open end portion and a second open end portion, the first open end portion being sealably attached to the outer surface of the tubular member, the second open end portion of the sleeve folding upward over the upper end of the tubular member and being sealable, the upper portion of the collection bag, which is sealably attached to the tubular member, in combination with the valve means and the second open end portion of the sleeve providing substantial containment of fluid within the disposable container after fluid is disposed therein; b. folding the second open end portion of the sleeve upward over the conically-shaped tubular member and sealing the second open end portion of the sleeve; c. injecting a first end of a double-end syringe into the injection site; and d. inserting a vacuumed test-tube over a second end of the syringe to create a pressure drop across the syringe thereby withdrawing a sample of the bodily fluid through the syringe and into a test tube.