Patent Application
20130092690
The present invention relates generally to biological specimen containers. More particularly, the present invention relates to containers used for collecting, storing, and transporting biological specimens to be used in assays, and more particularly to containers that chemically enhance the biological specimen.
Bodily fluids are collected for various reasons, including diagnosing illness, simple therapeutic removal, determining pregnancy, confirming or establishing levels of therapeutic agents, determining drug abuse, and profiling DNA composition. Blood, urine, and saliva are among the commonly collected bodily fluids for some or all of these purposes.
A variety of methods are used to collect bodily fluids, depending on the fluid and the intended use, and a corresponding variety of bottles, tubes, and other containers are employed to store and transport the fluids. The containers for holding the specimens must be both sealed and conveniently accessed. Commonly, these containers are a specimen tube with a sealing cap.
Often, immediately upon or shortly after their collection, bodily fluids must be chemically treated. Examples of required treatments are anticoagulants added to blood to prevent coagulation, lysing agents added to blood to burst cells, test reagents added to urine for drugs of abuse testing, and so on. Another example is saliva samples, for which preservative buffering solutions are often added to prevent destruction of components in the saliva. Saliva used for drugs of abuse testing or genetic testing often requires this treatment to maintain its composition for those purposes.
Because of the parallel needs to 1) store or transport biological specimens, and 2) chemically treat them, there is a need for container devices that can accept, chemically treat, and seal a biological specimen in a simple, convenient, reliable way.
One example of a container for collection of fluids is the BD Vacutainer® Blood Collection Tube produced by Becton, Dickinson and Company. These tubes are used to collect venous blood, and are an evacuated test tube with a rubber stopper. A conduit needle connects the test tube to venous blood through the rubber stopper. Blood is drawn into the test tube because the tube is evacuated and sealed with the rubber stopper during its manufacture. Appropriate chemicals, for example anticoagulants or preservatives, are pre-filled in the test tube to chemically treat the collected blood sample.
However, not all bodily fluids are or can be collected using evacuated tubes. Saliva, for example, is often collected either by inserting a sponge into the mouth or by spitting into a funnel-like container. In those cases, mixing the sample with chemical treatments requires different devices and methods. For the former, it is common to drop the saliva-saturated sponge into a test tube that contains a liquid buffer. Because the tube must be opened to add the sponge, the liquid buffer can be lost, unless extra care is taken to avoid tipping the tube until it is resealed. For the latter, simply adding a liquid buffer to the bottom of a closed funnel would be unsuitable for most saliva donations due to the possibilities of spilling or ingesting the buffer.
U.S. Pat. No. 5,335,673 to Goldstein, et al, discloses a device and method for collecting, chemically treating, and storing a saliva sample. The donor saturates a wand-mounted sponge with saliva by inserting the sponge into the mouth. The sponge is then inserted into a container which holds the required chemical treatment in liquid form. The wand is snapped off, leaving the sponge in the tube, after which the tube is sealed with a cap. Devices such as this are commercially available, including the Intercept® Oral Fluid Drug Test sold by OraSure Technologies of Bethlehem, Pa., and the Quantisal™ Oral Fluid Collection Device sold by Immunalysis Corporation of Pomona, Calif. Devices similar to these suffer from several drawbacks. First, collecting saliva with a mouth-inserted sponge is uncomfortable for the donor. Also, collecting and confirming an adequate volume of sample is not assured. Also, as previously mentioned, the liquid buffer can easily be lost if the tube is inadvertently tipped.
US Patent Application No. 20090216213 to Muir, et al, and US Patent Application No. 20110212002 to Curry, et al, disclose saliva collection devices wherein the donor spits into a short, round collection vessel, and a funnel-like collection vessel, respectively. In neither application does the liquid chemical agent simply reside in the collection vessel, but is instead sealed in a cap. Once the donation is complete, the cap is affixed to the collection container, whereby the liquid chemical is released to mix with the saliva. This arrangement prevents the undesirable possibility that the liquid chemical can be spilled, or worse, ingested, during the donation process. In both of these devices, a liquid buffer is pre-filled in the cap and sealed with a membrane. The membrane is punctured by cutting elements disposed in the collection containers, or portions thereof. Nevertheless, the devices disclosed in these patent applications exhibit drawbacks as well. For example, direct expectoration into an open container is clumsy and unsanitary. Donors may miss the funnel or container when spitting, may dribble sputum onto themselves or the administrator, and may spill the container, all with negative consequences. The requirement for repetitious and sequential positioning and spitting is cumbersome and exhausting. Also, the arrangement of features designed to puncture the membrane and free the liquid from the cap requires that sharp cutting elements be disposed in close proximity to the donor. This can be hazardous to the donor.
A specific drawback of Muir et al. includes the disclosed aspect ratio of the specimen container. The container diameter must be relatively large to accept the expectorated saliva, but this means that determining the actual volume of saliva accumulated is difficult. Curry et al. avoids that drawback by making the funnel separate and separable from the specimen container. But this arrangement suffers from increased complexity and additional parts. Once the donation is complete, the first cap, containing the liquid buffer, is affixed, which releases the buffer into the saliva. Next, that cap assembly must be removed, after which a seal cap is attached to the specimen container. Both of these applications disclose sample collection systems with pre-filled caps for which the cap puncturing features are disposed in the collection container or portions thereof. This arrangement leads to many drawbacks for these devices, including, for example, the aforesaid set of drawbacks.
U.S. Pat. No. 4,723,687 to Kutterer and U.S. Pat. No. 5,505,326 to Junko are prior art examples of caps with piercing elements disposed in the cap. These piercing elements pierce liquid containers that have been sealed with membranes over their openings. Neither of these, however, has a receptacle or vessel for mixing two components. Neither do they have compartments in the cap itself to hold a chemical constituent.
Additional prior art patents and applications include U.S. Pat. No. 4,150,950 to Takeguchi, et al., U.S. Pat. No. 5,283,038 to Seymour, U.S. Pat. No. 5,339,829 to Thieme, et al., U.S. Pat. No. 5,566,859 to Willis, et al., U.S. Pat. No. 5,567,309 to Classon, et al., U.S. Pat. No. 7,854,343 to Ellson, et al., U.S. Pat. No. 7,854,895 to Gallagher, et al., US Patent Application No. 20020015663 to Goldstein, et al.
No prior art patents or available devices adequately address the need to collect, treat, and store a biological sample in a simple-to-use, convenient, low-cost device. Therefore, there remains a need for a biological collection system that employs a pre-filled cap assembly for which the pre-filled agent is held in an ampoule and is accessible by puncturing into the ampoule, and for which the puncturing elements are disposed in the cap assembly, and also for which the act of applying the cap assembly to the collection container substantially at once exposes the pre-filled agent, allows mixing of the pre-filled agent and the biological sample, and seals the mixture within the assembly.
The present invention is a seal cap assembly for use with a biological specimen container. The cap includes an integral ampoule, or a vessel, that holds a pre-filled agent, such as a diluent, reagent, preservative, buffer solution, or the like, which is mixed with the specimen when the cap assembly is attached to the specimen container. Because of the pre-filled agent, which mixes into the biological specimen, the seal cap assembly permits stabilization, storage, and transport of biological fluid samples.
The cap assembly comprises, in one preferred embodiment, a housing, which includes a vessel, a liquid chemical agent filled into the vessel, a pierceable sealing membrane covering the opening of the vessel, a piercer to penetrate the membrane for access to the liquid in the vessel, and appropriate connecting features, such as screw threads, to mate with a specimen container.
In typical use, a biological sample is first collected into a collection tube. Then the cap assembly is inserted, advanced, and screwed onto the collection tube. This attachment action causes the piercer to advance, thereby penetrating the sealing membrane. Once this membrane is pierced, the liquid agent contained in the cap is free to flow into the collection tube and mix with the specimen contained therein. Simultaneous with advancing of the piercer (i.e. as the collection tube is inserted and screwed into the cap), seals are created between the cap assembly and the collection tube. This prevents either the specimen, the chemical agent, or the resultant mixture from coming out of the closed assembly, and allows for safe, secure transport or storage of the stabilized biological specimen. Whenever access to the specimen mixture is required, for example to remove some or all for a chemical assay, the cap assembly is removed from the collection tube. The specimen is then poured or pipetted out.
One suitable application of the present invention is to stabilize, store, and transport an oral fluid, or saliva sample for subsequent laboratory testing of genetic composition or for drugs of abuse. In those cases, one suitable method for collecting saliva is described in U.S. patent application Ser. No. 13/214,722 for a SALIVA COLLECTION DEVICE, which is hereby incorporated by reference herein. The device disclosed in that application collects a neat saliva sample. Other methods of collecting the saliva sample may also be used with the present invention. For example, either an oral sponge device or a spit funnel device may be used to collect a saliva sample, and the corresponding specimen container can be used with the present invention. Saliva, due to its chemical nature, is not adequately stable for use in some tests with some time delays. Therefore the present invention can be used to stabilize the collected saliva sample, and to seal it in the collection tube, thus facilitating transport and stable storage until the desired laboratory test or assay can be completed.
An object of the present invention is to provide a safe, convenient, inexpensive sealing cap that is pre-filled with a chemical agent, and that is used to stabilize, store, and transport a biological specimen in a specimen container.
We now refer to the ready-to-use condition of an embodiment of the present invention, ampoule cap assembly 101, which is shown in
Pre-filled agent 203 can be any liquid, powder, lyophilized cake, lyophilized pellet, gel, and so forth, that is intended to mix with the biological specimen contained in specimen tube 103. Pre-filled agent 203 may, for example, be a preservative, a test reagent, or a buffering solution. One embodiment of the present invention uses a stabilizing buffer as pre-filled agent 203, which combines with a saliva sample contained in specimen tube 103. This stabilizes the saliva sample so it can be used some time later, for example, for genetic or drugs of abuse testing.
Retention member 207 configured as a sealing membrane retains pre-filled agent 203 in the interior 303 of vessel 304 by bonding to a staking rim 305 of vessel walls 301. Sealing membrane 207 must only meet requirements for the intended application, specifically environmental barrier properties, ability to seal to the selected substrate material, and frangibility, Many alternatives are commonly available as standard technology for packaging pharmaceuticals, food, and in-vitro diagnostics. Sealing membrane 207 can be, for example, a metal foil/thermoplastic co-extrusion commonly used in packaging technology. Sealing membrane 207 can be bonded to staking rim 305 using, for example, adhesives, RF heating, or direct heating. In other embodiments the retention member can be a frangible member or capsule.
Actuating member 209 configured as a piercer movably assembles onto the vessel wall 209 portion of ampoule cap housing 201 via guide walls 307. Piercer 209 includes seal lip 309 which sealingly rides along seal surface 311, which is a portion of the outer side of vessel walls 301. Piercer 209 includes piercing tip 313 and annulus 315, which features are employed to pierce and guide sealing membrane 207. Piercer 209 can be injected molded out of any suitable thermoplastic such as styrene or polypropylene. Actuating member can also have other configurations to break or sever the retention member releasing the prefilled agent. Ampoule cap housing 201 includes internal threads 317, which engage with external threads 105 of specimen tube 103 (
Ampoule cap assembly 101 is shown in
In
Flap 501 of sealing membrane 207 has now been displaced as shown, so as to be substantially away from vessel opening 205 (
Because vessel 304 is now in fluid communication with specimen tube volume 403, its contents can be made to mix with specimen 401 to create a specimen mixture 701 as shown in
Access to specimen mixture 701 is gained by unscrewing ampoule cap assembly 101 from specimen tube 103, which simultaneously removes all its components as well, sans pre-filled agent 203. Specimen mixture 701 can be pipetted or poured out for any desired subsequent use.
The above disclosure is related to the detailed technical contents and inventive futures thereof. People skilled in this field may proceed with a variety of modifications and replacements based on the disclosures and suggestions of the invention as described without departing from the characteristics thereof. Nevertheless, although such modifications and replacements are not fully disclosed in the above descriptions, they have substantially been covered by the spirit and technical theory of the subject invention.
The present application claims the benefit of U.S. Provisional Patent Application No. 61/548,473, filed Oct. 18, 2011, which application is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61548476 | Oct 2011 | US |
