US20130092690A1 - Seal cap with pre-filled agent for a specimen container - Google Patents

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Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D51/00—Closures not otherwise provided for
  • B65D51/24—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
  • B65D51/28—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials
  • B65D51/2807—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container
  • B65D51/2814—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by piercing, cutting or tearing an element enclosing it
  • B65D51/2828—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by piercing, cutting or tearing an element enclosing it said element being a film or a foil
  • B65D51/2835—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by piercing, cutting or tearing an element enclosing it said element being a film or a foil ruptured by a sharp element, e.g. a cutter or a piercer
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/0045—Devices for taking samples of body liquids
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/0096—Casings for storing test samples
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/0045—Devices for taking samples of body liquids
  • A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B2010/0009—Testing for drug or alcohol abuse

Definitions

• 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.
• 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.
• 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.
• 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 QuantisalTM 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.
• the membrane is punctured by cutting elements disposed in the collection containers, or portions thereof.
• the devices disclosed in these patent applications exhibit drawbacks as well.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• FIG. 1 is an overall assembly perspective drawing showing an ampoule cap assembly according to an embodiment of the present invention and a mating specimen collection tube.
• FIG. 2 is an exploded perspective view of an ampoule camp assembly according to an embodiment of the present invention.
• FIG. 3 is a cross-section view of an embodiment of present invention in a ready-to-use state.
• FIG. 4 is a cross section view showing an ampoule cap assembly of an embodiment of the present invention at the beginning position of engagement to a specimen tube containing a specimen.
• FIG. 5 is a detail cross-section view of an ampoule cap assembly of an embodiment of the present invention in partial engagement with a specimen tube, wherein access to the ampoule portion of ampoule cap assembly has begun.
• FIG. 6 is a detail cross-section view of an ampoule cap assembly of an embodiment of the present invention fully engaged with the specimen tube, and wherein the fill agent has exited from the ampoule cap assembly.
• FIG. 7 is a full cross-section view showing an ampoule cap assembly of an embodiment of the present invention fully engaged with the specimen tube, and the resulting mixture of pre-filled agent and specimen.
• FIG. 8 is a perspective view of the sealing membrane in the as-pierced configuration for one embodiment of the present invention.
• FIG. 9 is a perspective cross-section view of piercer showing the internal feature of one embodiment of the present invention.
• FIG. 1 shows one embodiment of an ampoule cap assembly 101 of the present invention.
• Ampoule cap assembly 101 can removably attach to a specimen tube 103 by way of external threads 105 , said threads in particular embodiments may be internally oriented.
• Ampoule cap assembly 101 has corresponding internal threads, as well as other suitable mating features to attach ampoule cap assembly 101 to specimen tube 103 .
• Specimen tube 103 will have been filled with a suitable volume of a biological sample fluid that needs chemical conditioning prior to storage, transport, or testing.
• FIG. 2 shows the constituent components of an embodiment of ampoule cap assembly 101 , starting with an ampoule cap housing 201 .
• a pre-filled agent 203 is loaded into the ampoule cap housing 201 through vessel opening 205 .
• Pre-filled agent 203 is captured and sealed within ampoule cap housing 201 via sealing membrane 207 .
• Piercer 209 movably assembles into the ampoule cap housing 201 .
• Ampoule cap housing 201 may incorporate ribs 211 to aid the user in assembling and tightening of the ampoule cap assembly 101 to the specimen tube 103 .
• Ampoule cap housing 201 can be injection molded out of any suitable thermoplastic, such as polycarbonate, styrene, polyester, or polypropylene.
• Ampoule cap housing 201 includes vessel walls 301 , which define a chamber or vessel 304 .
• Vessel 304 defines the contained volume for pre-filled agent 203 or further frangible capsule.
• 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 ( FIG. 1 ).
• FIG. 4 shows the arrangement of ampoule cap assembly 101 and specimen tube 103 at a position wherein the specimen tube 103 has been initially inserted into ampoule cap assembly 101 just prior to when any internal actions or movements are initiated.
• Specimen 401 will have previously been collected directly or indirectly into specimen tube volume 403 of specimen tube 103 .
• specimen 401 can be saliva collected using any suitable method, one such method being that disclosed in U.S. Patent Application Publication No. 2012/0046574, previously incorporated by reference herein.
• Other patents and patent publications, each of which is incorporated by reference herein, that show certain elements and features or functionality that may be combined with or used with aspects of the instant invention are as follows: U.S. Pat. No.
• Ampoule cap assembly 101 is shown in FIG. 5 assembled to specimen tube 103 in an intermediate position between initial insertion and final position.
• Piercer 209 has moved so that its piercing tip 313 has punctured sealing membrane 207 and created a flap 501 out of a portion of sealing membrane 207 .
• Seal ring 503 has now sealingly engaged with seal surface 505 of specimen tube 103 .
• Tube end 509 of specimen tube 103 rests against flange 507 , thereby arresting further motion between specimen tube 103 and piercer 209 .
• Seal lip 309 has slid along seal surface 311 of ampoule cap housing 201 , also creating a seal.
• the ampoule cap assembly 101 is shown fully assembled to specimen tube 103 .
• Internal threads 317 of ampoule cap housing 201 have mated with external threads 105 of specimen tube 103 .
• Seal lip 309 is in sealing engagement with seal surface 311
• seal ring 503 is in sealing engagement with seal surface 505
• tube end 509 contacts flange 507 , which in turn contacts stop 601 of ampoule cap housing 201 . All of this defines a final, arrested position in which the internal volume defined by vessel 304 and specimen tube 103 are sealed, which prevents leaking and loss of contents.
• Flap 501 of sealing membrane 207 has now been displaced as shown, so as to be substantially away from vessel opening 205 ( FIG. 2 ).
• vessel 304 is now in fluid communication with specimen tube volume 403
• Annulus 315 of piercer 209 is sized and shaped to shear sealing membrane 207 into the geometry flap 501 , and to move it toward an internal surface of vessel wall 301 .
• 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 FIG. 7 .
• pre-filled agent 203 is a liquid, it may flow by gravity alone into specimen tube 103 .
• pre-filled agent 203 is a dry component, specimen mixture 701 can be produced by agitation of the sealed assembly.
• specimen mixture 701 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.
• FIG. 8 shows the geometry of flap 501 , which is formed from a portion of sealing membrane 207 , in the form created in an embodiment of the present invention.
• sealing membrane 207 can be made to tear into an “X” pattern, starting at its center.
• the geometry of flap 501 in FIG. 8 is a suitable result, but does not represent the only suitable geometry employable in the present invention.
• FIG. 9 shows piercing tip 313 and annulus 315 of piercer 209 .
• This feature, along with shearing edge 901 work together with the inner surface of vessel walls 301 ( FIG. 3 ) to form the flap 501 of FIG. 8 .
• Shearing edge 901 acts with vessel walls 301 to create a manner of shearing action on sealing membrane 207 .
• FIG. 9 shows one embodiment of piercer 209 , but should not be taken to limit the scope of the present invention vis-à-vis its specific geometry for piercing membrane 207 .
• piercing tip 313 need not be a point, and need not be aligned with annulus 315 .
• Piercing tip 313 can be positioned on the center axis of piercer 209 , and initiate piercing in the center of membrane 207 .

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• Heart & Thoracic Surgery (AREA)
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Abstract

Description

Claims (20)

Priority Applications (1)

Applications Claiming Priority (2)

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Cited By (27)

Citations (18)

• 2012
  • 2012-10-18 US US13/655,127 patent/US20130092690A1/en not_active Abandoned

Patent Citations (18)

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