Classifications

• • 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
• • 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
• • C—CHEMISTRY; METALLURGY
  • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
  • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
  • C12M1/00—Apparatus for enzymology or microbiology
  • C12M1/26—Inoculator or sampler
  • C12M1/265—Pipettes; Syringes; Suction devices

Definitions

• This invention pertains to a device for the sterile collection and transport of bodily fluid specimens for medical and/or pharmaceutical purposes, featuring a specimen collection receptacle that enables specimens to be collected and transported securely for processing in microbiology and/or cytology laboratories, such that the protection of personnel is guaranteed at every work phase, including sampling, transport, and specimen processing.
• the fluid collection device is connected to a bronchoscope so as to draw in respiratory fluids and bronchoalveolar washing fluid at the far end; the channel openings of the inner and outer tubes are sealed with a double air seal so that the sterile environment is guaranteed both when the device is inserted into the bronchoscope, and during the entire time the specimen is collected; an umbrella-shaped apparatus is opened to ensure the inner and collecting tubes do not touch the upper respiratory fluid adhering to the surface of the alveoli, rendering the collected fluid specimen completely reliable; bronchoalveolar lavage is performed in order to ensure that the washing fluid does not come into contact with the upper respiratory fluid and that the sampling procedure does not contaminate upper respiratory flora; the quantity of sample taken is continuously monitored, so that both the rapid sampling process, and the documentation of the process might be executed more comfortably; the specimen can be taken either manually or automatically.
• Hungarian patent specification PI 600196 for a ‘Fluid Sampling Device,’ a document which describes another apparatus used for the collection of specimens, in this case having a handle and, attached to the handle, a sampling element, constructed so the ends of the handle (4,5) are open sections of tube (1); one end of the sampling element (21) is closed; at the distal end (5) of the section of tube (1) is a flexible sac (2) that is secured to the section of tube (1) in air-tight fashion; and at the proximal end (4) of the section of tube (1) is an operating sac (3) that is also secured to the section of tube (1) in air-tight fashion.
• neither description features two tube ends— the end of a tube attached to a vacuum and end of a fluid suction tube — arranged asymmetrically at opposite ends of the fluid collection receptacle; or a mechanism to constrict the vacuum and fluid suction tubes; or a laboratory sampling outlet, the open end of which is disposed in the lower part of the fluid collection receptacle and the closed end of which is disposed outside the fluid collection receptacle.
• neither solution can ensure that no fluid will ever enter the vacuum tube.
• the article mentions a fluid collection receptacle, as well as the use of an external vacuum source, but makes no mention of any kind of arrangement of tube ends in said receptacle.
• the objective set for this invention is the elimination of the deficiencies inherent in known solutions and the creation of a bodily fluid specimen collection and transport device that enables both the collection of microbiological and cytological specimens from pathological fluids produced in the human body, and the transport of said specimens to a processing (testing) location, such that both the sampling and transportation procedures occur in sterile conditions, that persons working to transport the specimens are not subjected to risk of infection during transport, and that when the transported specimen is being processed and the fluid extracted from the fluid collection receptacle, all personnel involved are completely protected from infection.
• the solution according to this invention is based on the realisation that with regard to the device and process serving the use of bodily fluids for medical and/or pharmaceutical purposes, a solution employing a closed system is the only way to protect healthcare workers from becoming infected during the processes of specimen collection, transport, and testing. This may be accomplished if in the device used, the end of the section of the vacuum tube that is within the fluid collection receptacle is disposed asymmetrically at the upper end of the receptacle opposite the sections of the ends of the fluid suction tube and laboratory sampling outlet that are within in the fluid collection receptacle, the latter two of which are disposed at the lower end of the fluid collection receptacle.
• the subject of the invention is a device for the sterile collection and transport of bodily fluid specimens for medical and/or pharmaceutical purposes, having a vacuum tube that is attached at its free end to an external vacuum source, a fluid suction tube with luer taper fitting for the purpose of connection to a standard-coupling fluid suction device, and, at the point where the two tubes meet, a fluid collection receptacle.
• the invention is characterised in that the open end of the section of the fluid suction tube located within the receptacle, which fluid suction tube is inserted into the fluid collection receptacle — closed at its lower and upper ends — in immovable fashion, and the open end of the section of the vacuum tube located within the fluid collection receptacle, which vacuum tube is also inserted into the fluid collection receptacle in immovable fashion, are disposed at opposite ends of the receptacle, that is, the open end of the vacuum tube is arranged at the upper end of the fluid collection receptacle, while the open end of the fluid suction tube is arranged at the lower end of the fluid collection receptacle.
• the device has separate opening and closing mechanisms for the vacuum and the fluid suction tubes that regulate constriction, as well as a laboratory sampling outlet, the open end of which is located at the lower end of the fluid collection receptacle and the closed end of which is located on the outside of the fluid collection receptacle.
• Figure 1 shows a preferred embodiment of the bodily fluid specimen collection and transport device according to this invention
• Figure 2 shows the fluid collection receptacle according to this invention, with its upper end and lower ends, the fluid suction tube, which can be connected to an external vacuum source, the laboratory sampling outlet, and the vacuum tube,
• Figure 3 shows the laboratory sampling outlet, the fluid suction tube, and, placed on the tube, the opening and closing mechanism
• Figure 4 shows both the vacuum tube, and the fluid collection receptacle with its lower and upper ends.
• Figure 5 shows the laboratory sampling outlet and the fluid suction tube with the upper closing part of the fluid collection receptacle.
• FIG. 1 Visible on Figure 1 is the vacuum tube A with its free end, to which an external vacuum source can be connected, and the fluid suction tube C with its luer taper fitting Cl. Disposed on each of these tubes is a tube opening and closing mechanism E. At the point where the vacuum tube A and fluid suction tube C intersect is a fluid collection receptacle D, in which the open ends of the sections of the tubes that are in the fluid collection receptacle D are arranged in opposite ends of the receptacle. Also visible is the laboratory sampling outlet B, the closed end of which is outside the fluid collection receptacle D, and the open end of which is located inside the fluid collection receptacle D at its lower end Dl.
• FIG. 2 Visible in Figure 2 is the fluid collection receptacle D at the intersection of the vacuum tube A and the fluid suction tube C with its permanently closed lower end Dl and upper end D2, through which the vacuum tube A and fluid suction tube C are disposed in opposite directions. Also visible is the closed end of the laboratory sampling outlet B that protrudes from the receptacle and the open end of the same at the receptacle’s lower end Dl.
• FIG. 3 Visible in Figure 3 is the closed end of the laboratory sampling outlet B protruding from the upper end D2 of the fluid collection receptacle D, the fluid suction tube C, and on it, the tube opening and closing mechanism E. Also visible is the luer taper fitting Cl on the fluid suction tube C.
• FIG. 4 Visible in Figure 4 is the vacuum tube A inserted through and affixed to the lower end Dl of the fluid collection receptacle D, the end of which reaches the fluid collection receptacle’s D upper end D2.
• FIG. 5 Visible in Figure 5 are the closed end of the laboratory sampling outlet B inserted through and affixed to the upper closing part of the receptacle, the open-ended section of the same on the other side, and the placement of the fluid suction tube C.
• the following section describes in detail how the device functions and how it is used:
• the free end of the vacuum tube A is equipped with a fitting, which is attached to an external vacuum source; a standard-coupling fluid suction device, preferably a hypodermic needle, is connected to the luer taper fitting Cl on the fluid suction tube C and inserted into the fluid, during which time the tube opening and closing mechanism E on each of the tubes is set to the open state, so that both the vacuum tube A, and fluid suction tube C permit flow, thus enabling the fluid to be drawn into the lower end D1 of the closed fluid collection receptacle D.
• a standard-coupling fluid suction device preferably a hypodermic needle
• the device is separated from the vacuum source, and the tube opening and closing mechanism E is used to constrict the vacuum tube A and fluid suction tube C, thus closing the fluid in the fluid collection receptacle D and holding it there.
• the closed external end of the laboratory sampling outlet B is cut off and the fluid specimen removed in compliance with work safety regulations, preferably such that it is drawn out using a hypodermic needle through the laboratory sampling outlet B.
• the invention may be used by all out- and/or in-patient healthcare providers.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• Pathology (AREA)
• Heart & Thoracic Surgery (AREA)
• Veterinary Medicine (AREA)
• Chemical & Material Sciences (AREA)
• Biotechnology (AREA)
• Hematology (AREA)
• Wood Science & Technology (AREA)
• Zoology (AREA)
• Organic Chemistry (AREA)
• Medicinal Chemistry (AREA)
• Microbiology (AREA)
• Sustainable Development (AREA)
• Biochemistry (AREA)
• General Engineering & Computer Science (AREA)
• Genetics & Genomics (AREA)
• Sampling And Sample Adjustment (AREA)

Applications Claiming Priority (2)

Publications (1)

Family

ID=89993106

Family Applications (1)

Country Status (3)

Family Cites Families (6)

• 2020
  • 2020-04-15 HU HU2000133A patent/HUP2000133A1/hu unknown
• 2021
  • 2021-04-14 EP EP21725802.9A patent/EP4135589A1/de active Pending
  • 2021-04-14 WO PCT/HU2021/000003 patent/WO2021209776A1/en unknown

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