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
  • A61B10/007—Devices for taking samples of body liquids for taking urine samples

Definitions

• the fore-stream urine contaminants produce a high incidence of false positive lab test results that are unfortunately derived from external contaminants located around the external urogenital anatomic parts. These apparently “innocent” false contaminants are dragged along the apparently clean urinary stream from the bladder during its excretion process.
• this unintentionally contaminated fore-stream urine while “rinsing" through the patient's urogenital pathway, is collected in a conventional single chamber collection container and then mixes with the later cleaner, mid-stream sample, such badly mixed midstream sample is regarded as unsuitable or unacceptable for lab diagnosis procedures.
• a problem associated with such mid-stream urine collection is the assuring of an appropriate cleansing fore- stream urine flow (which is not used for the bacteriological analysis) .
• the attachment member includes a handle and means for detachably attaching the handle to the attachment member.
• Means are preferably included for forcing the stopper into a tight sealing relationship with the orifice so as to assure that liquid does not leak between the upper and lower chambers .
• the stopper forcing means include an annular, spring-like, flexible web formed in the bottom cover around a downwardly extending bottom cover region, web being responsive to a downward pushing on the device onto the downwardly extending bottom cover region for deflecting upwardly in a manner causing a central upstanding region of the bottom cover to engage the stopper and force the stopper upwardly into the orifice and latch the stopper external annular bead into the locking flange annular recess for tightly sealing the orifice against liquid leakage past the stopper.
• the magnetic elements positively lock the stopper into the orifice and latch the stopper external annular bead into the locking flange annular recess so as to assure that liquid does not leak past the stopper between the upper and lower chambers .
• an aqueous liquid-activated adhesive is applied to the transverse wall around the orifice and a removable spacer is disposed between the stopper and the orifice to prevent device pre- use adhering of the stopper into the orifice.
• the device body be constructed of a rigid plastic material which comprises a high density polypropylene, and that the upper and lower chambers have respective volumes of about 80 ml and about 100 ml for use of the device for urine collection.
• FIG. 2 is a top, plan view of the containment device of FIG. 1 showing features of the top cover and showing the handle detachably attached to the device body;
• FIG. 3 is a perspective view of the handle of FIGS. 1 and 2, showing, at a lower end, a T-slot element whereby the handle can be detachably attached to the device body;
• FIG. 4 is a detail perspective drawing of a attachment element formed on the collection device body for receiving the T-slot element of the handle of FIG. 3 to thereby enable detachable attachment of the handle to the device;
• FIG. 1 is a top, plan view of the containment device of FIG. 1 showing features of the top cover and showing the handle detachably attached to the device body;
• FIG. 3 is a perspective view of the handle of FIGS. 1 and 2, showing, at a lower end, a T-slot element whereby the handle can be detachably attached to the device body;
• FIG. 4 is a detail perspective drawing of a attachment element formed on the
• handle 110 preferably has an overall length, L x , that may be about 4.5 inches and has a generally central bend, ⁇ , that may be about 45 degrees; moreover, in combination, handle attachment region 118 and device body fitting 112 mount the handle at an upward angle, ⁇ , of about 30 degrees (FIG. 1) .
• Fig. 5 shows a top view of device body 102, which may be constructed of a rigid plastic material, such as high density polypropylene, and may be either transparent, translucent or opaque. As shown in the vertical cross section of FIGS.
• liquid 250 such as a patient's urine
• upper chamber 142 of device body 102 lower chamber 144 being shown already filled with the liquid (urine) which has caused float 180 to push orifice stopper 160 upwardly so that stopper region 162 is pushed into sealing relationship with orifice 146, whereupon the liquid has then started filling upper chamber 142.
• urine 252 contained in lower chamber 144 should constitute fore-stream urine, the lower chamber having sufficient volume to assure that urine 254 being collected in upper chamber 142 will constitute uncontaminated midstream urine.
• Device body hole 120 is provided for venting air from lower chamber 144 to relieve pressure therein and thereby prevent any liquid 252 from bleeding past orifice stopper 160. In some situations it may, however, be necessary or desirable to have access to urine 252 in lower chamber 144 after orifice stopper 160 (and variations thereof) has been locked into orifice 146, as described above. For example, when testing for drugs in an individual's urine it may be necessary, or required by law, to retain, in a tamperproof manner, a reserve or second portion of the individual's urine specimen.
• THIRD VARIATION DUAL-CHAMBER DEVICE 100c It will be appreciated that a locking of orifice stopper 160 into orifice 146 (as described above for devices 100, 100a and 100b) in a more automatic manner will, at least in some circumstances, be more desirable than the mechanical locking method described above which requires manually pushing down on dual-chamber device 100 or 100a to flex bottom cover web 192 into its over-center locking condition. To this end, there is disclosed in FIGS. 32-38 a spring-type orifice stopper locking assembly 280 for a third variation dual-chamber device 100c (FIGS. 35-37).
• gas generator assembly 340 is installed in dual- chamber device lOOe within orifice stopper column 168b and is attached to bottom cover upper surface 318. As shown in the pre-use condition of FIG. 41, orifice stopper column 168b is resting on bottom cover upper surface 318, as is float 180. Shown in detail in FIG. 42, gas generator assembly tablet housing 344 includes a top 350, a cylindrical side wall 352 and a bottom 354.
• gas bubbles 362 rising from gas generator 340 pushs orifice stopper 160 upwardly into tight sealing relationship with orifice 146 with stopper seal 216 forced in a sealing relationship against lower regions of orifice ring 148, and including "latching" stopper locking bead 166 into orifice locking recess 152, thereby positively locking the stopper into the orifice to assure no liquid leakage occurs between upper and lower chambers 142 and 144.
• the generated gas locking of orifice stopper 160b into orifice 146 is accomplished when lower chamber 144 is filled with aqueous liquid (urine) 152 and without any manual intervention.

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

Applications Claiming Priority (5)

Publications (1)

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• 2004
  • 2004-06-10 MY MYPI20042232 patent/MY142781A/en unknown
  • 2004-06-15 WO PCT/US2004/019680 patent/WO2005003725A2/en active Application Filing
  • 2004-06-15 EP EP04755688A patent/EP1648291A2/en not_active Withdrawn
  • 2004-06-15 CA CA002530586A patent/CA2530586A1/en not_active Abandoned
  • 2004-06-15 JP JP2006518658A patent/JP4568275B2/ja not_active Expired - Fee Related
  • 2004-06-15 AU AU2004254594A patent/AU2004254594A1/en not_active Abandoned

Non-Patent Citations (1)

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