Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
  • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
  • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
  • B01L3/5021—Test tubes specially adapted for centrifugation purposes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; 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—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; 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—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
  • A61B2010/0009—Testing for drug or alcohol abuse
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
  • A61B2050/002—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers having adhesive means, e.g. an adhesive strip
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
  • A61B2050/005—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
  • A61B2050/0051—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover closable by rotation
  • A61B2050/0056—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover closable by rotation about a lateral axis in the lid plane
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
  • A61B2050/005—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
  • A61B2050/0062—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover closable by a combination of rotation and translation
  • A61B2050/0064—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover closable by a combination of rotation and translation by screwing

Definitions

• the invention relates to a system for collecting and storing samples of saliva for body fluid constituent analysis.
• Saliva testing has recently come to the forefront as a preferred option in body fluid constituent analysis.
• the collection procedure is non-invasive, and saliva has been found to be a very reliable carrier of analyte indicators.
• the method and collection kit in one mode and embodiment thereof, further make use of a centrifuge, which is standard equipment in any test lab establishment.
• a method of collecting saliva samples for body fluid analysis comprises the following steps:
• the method is continued with a step of squeezing the saliva from the absorptive means, collecting the squeezed-out saliva at the bottom of the collection container, and then harvesting the saliva from the bottom of the container by opening a fluidic conduit at the bottom and utilizing the thus harvested saliva in a saliva testing method.
• the method is continued with a step of centrifuging the absorptive means in fluidic communication with the collection container and driving the saliva out of the absorptive means and into the collection container;
• a filter assembly is placed between the absorptive means and the collection container for molecular weight-selective collecting of saliva in the centrifuging step.
• an assembly for collecting saliva for body fluid analysis comprising:
• absorptive means for placing into a patient's oral cavity and for absorbing saliva therein;
• a collection and centrifuging assembly having a cavity formed therein for receiving the absorptive means, the collection and centrifuging assembly including
• a holder section for receiving and holding therein the absorptive means
• a collection section attached to and fluidically communicating with the holder section, the collection section receiving the saliva from the absorptive means when the collection and centrifuging assembly is centrifuged;
• cap means for closing off the collection section after the holder section has been removed therefrom, for facilitating storage and shipping of the saliva collected in the collection section during centrifuging.
• the assembly includes a filter assembly disposed between the holder section and the collection section for filtering the saliva prior to collection in the collection section.
• the filter assembly includes a substantially annular wall for fluid-tightly connecting between the holder section and the collection section, a wire support permanently attached to the substantially annular wall, and a molecular weight membrane for selectively filtering the saliva of materials with a molecular weight greater than a rating of the molecular weight membrane.
• the absorptive means include a cap member for placing on the holder section and fluid-tightly sealing a top of the holder section, and a sponge member for absorbing the saliva permanently attached to the cap.
• the sponge member is preferably formed as a pacifier nipple.
• the assembly includes a safety flange attached to the cap member for preventing ingestion of the absorptive means when the sponge member is placed into the patient's oral cavity.
• the collection assembly is quite similar to a pacifier, with the essential difference that the nipple portion is formed of absorptive material, so as to absorb saliva while the nipple placed in the patient's mouth.
• the absorptive means are impregnated with a flavor substance for stimulating a patient's saliva production.
• a flavor substance for stimulating the gland may be lemon, lime, orange, or similar flavors.
• absorptive means for placing into a patient's oral cavity and for absorbing saliva therein;
• a collection container defining a cavity adapted to receiving the absorptive means, the collection container having resilient walls adapted to collapse towards one another upon being squeezed and to drive the saliva from the absoptive means when the absorptive means is disposed in the collection container.
• the walls of the collection container are elastically resilient.
• the collection container further comprises a dispensing end in a vicinity of which the saliva is collected, the dispensing end having a nipple formed thereon through which the saliva is removed from the collection container.
• Fig. 1 is a sectional view of a cap and sponge collection assembly according to the invention
• Fig. 2 is an exploded, partly broken-away, side-elevational view of a three-component assembly according to the invention
• Fig. 3 is a bottom-plan view of a filter insert
• Fig. 4 is a side-elevational view of a centrifuge vial, i.e. the bottom component shown in Fig. 2, with a closure cap;
• Fig. 5 is a view similar to Fig. 2 of an alternative embodiment of the invention.
• Fig. 6 is a view similar to Fig. 1 of another alternative embodiment.
• a cap and sponge assembly 1 (the collection component) , which includes a cap 2, an optional handle 3, an optional safety flange 4 and a sponge 5.
• the essential components of the assembly 1 are the cap 2 and the sponge 5.
• the handle 3 may be provided for easier handling of the assembly 1, and it may be integrally formed on the cap 2 or it may be glued thereon.
• the safety flange 4 is specifically recommended for infant testing.
• the safety flange 4 may be removable, and for that purpose it would be spot-welded (spot weld 6) to the cap 2 or provided with a safety ring similar to those found on plastic closures of milk jugs.
• the cap and sponge assembly 1 is quite similar to an infant pacifier, and the assembly, and particularly the sponge 5, may be shaped in all possible pacifier shapes.
• the sponge 5 is permanently locked into the inside of the cap, so as to allow a liquid-tight seal when the cap is placed on the components illustrated in Fig. 2.
• the sponge 5 is either polypropylene, polyethylene, polyurethane, cellulose, or blends therecf. More specifically, the sponge is formed of water-catalyzed polyurethane and more specifically it is prefer&bly formed of HYPOL, available from Hampshire Chemical Corporation. That material has very high absorption density and excellent tensile strength. Similar materials may be used. Factors to be considered, however, are that the material must be largely inert, it must not easily break so as to prevent any ingestion of solid material, and it must have good absorptive qualities. Additionally, as will become clear from the following description, it should be able to withstand centrifugation and be able to release all or most of the saliva previously collected.
• the cap and sponge assembly 1 is placed on a sponge holder section 7, in that the sponge 5 is inserted and the cap 2 is securely fastened thereto.
• a simple friction fit between the sponge holder section 7 and the cap 2 will in most cases suffice. It is also possible, however, to provide the cap 2 and the sponge holder section 7 with mutually meshing threads.
• the sponge holder section 7 is preferably formed as a polypropylene, polyethylene or styrene cylinder and it is provided with an attachment flange 9 at its bottom.
• a filter assembly 8 is attached at the flange 9 at the bottom of the sponge holder section 7.
• the filter assembly is preferably attached by a substantially circumferential ultrasonic weld.
• the filter assembly 8 has a molecular weight cut-off membrane 10 supported on a simple wire mesh 11.
• the membrane 10 may be adjusted to any mesh density. By way of example, a 10,000 MW (molecular weight) membrane may be used for cleaning the saliva. Other mesh sizes are also possible, depending on the specimen requirements.
• a bottom stub portion of the filter assembly 8 inserts tightly into a centrifuge container 12, i.e. a saliva collection tube 12 or collection container 12.
• the filter 8 may come attached to the collection tube 12, so as to provide an integrated system of the components 7, 8 and 12.
• the filter assembly 8 may be attached to the collection tube 12 by means of a ultrasonic spot weld 13, or the like. It is important, in this respect, that the strength of the bond between the filter 8 and the collection tube 12 be smaller than that between the filter 8 and the sponge holder section 7. This ensures that, after centrifugation, the filter assembly 8 (together with the sponge holder 7 and the cap and sponge assembly 1 detaches from the collection tube 12. After separation, then, the collection tube 12 is closed and sealed with a standard threaded cap 14.
• the cylindrical tubes have an outer diameter of 1/2 inch, the length of the collection tube is 2.125 inches, the length of the filter assembly is 5/16 of an inch and the sponge holder with the attached cap is 1.75 inches.
• the collection tube 12 is also formed of a polypropylene or a similar material, and it is conical on the bottom. This facilitates sample withdrawal.
• the threaded cap ensures that the collected sample can be stored and shipped without drying or spilling.
• a frosted area 15 may be provided on the collection tube 12, so as to allow proper libelling.
• the assembly is provided for a specific test application.
• the bottom of the collection tube 12 holds a certain chemical reactant.
• an indication is triggered. That indication may, for instance, be in the form of a colorimetric reaction.
• the collection tube 12 is formed of transparent or translucent material, or that a viewing window is provided.
• Fig. 5 we have also provided a much simplified, yet integrated system for saliva collection and analysis.
• the embodiment is particularly based on the premise that saliva testing by colorimetry and the like has recently seen a flurry of novel developments which are all hindered by the fact that the prior art systems for collecting the saliva are typically cumbersome and slow, and/or the amount of saliva thus harvested is often not sufficient.
• the recent call for full disposability of such devices is answered as well with the embodiment of Fig. 5.
• the nipple 5 of Fig. 5 may also be formed of HYPOL material which is directly glued to a lid 16.
• the adhesive connection is indicated at 17 and it is preferably formed by a LOCKTITE system (primer, accelerator, adhesive) , a cyano-acrylic medical grade adhesive.
• the lid 16 is internally threaded so that it can be screwed onto the tube 12.
• the tube 12 is formed of thin, i.e. squeezable material. Accordingly, when the sponge 5 is disposed in the tube 12 and the tube 12 is laterally squeezed, the saliva is dr_ven from the sponge 5 and it collects at the bottom of trie tube 12.
• the bottom of the tube 12 is provided with a nipple 18.
• the nipple 18 can be severed (e.g. cut off with scissors) and the saliva exits from the nipple and into/onto any desired surface on which the saliva testing (e.g. HIV, Hepatitis, Drug of Abuse, PSA, etc.) may be performed.
• the nipple 18 may be provided with a twist-off cap 19.
• the sponge nipple 5 may be directly molded into the cap 16 without requiring an adhesive layer 17.
• the directly molded foam rubber after being molded, is allowed to vent through a casting hole vent 20.
• a mold opening 23 in the cap 16 is undercut so as to positively and form-lockingly retain the nipple 5 structure in the cap 16.

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• Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Hematology (AREA)
• General Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Engineering & Computer Science (AREA)
• Pathology (AREA)
• Heart & Thoracic Surgery (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• Biomedical Technology (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Pulmonology (AREA)
• Analytical Chemistry (AREA)
• Clinical Laboratory Science (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Sampling And Sample Adjustment (AREA)
• Investigating Or Analysing Biological Materials (AREA)

Applications Claiming Priority (5)

Publications (2)

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• 1995
  • 1995-05-09 WO PCT/US1995/005889 patent/WO1995030484A1/en not_active Application Discontinuation
  • 1995-05-09 MX MX9600525A patent/MX9600525A/es unknown
  • 1995-05-09 CA CA002170998A patent/CA2170998A1/en not_active Abandoned
  • 1995-05-09 EP EP95919794A patent/EP0713424A4/de not_active Withdrawn
  • 1995-05-09 AU AU25473/95A patent/AU2547395A/en not_active Abandoned

Non-Patent Citations (2)

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