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
• • 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

Definitions

• This invention relates generally to specimen cups, chemical test strips for analyzing contents of analytical specimen cups and, specifically, to analytical specimen cups which are combined with chemical test strips.
• US patent 4,827,944 to Nugent discloses a body fluid sample collection tube having a number of bores therein for allowing a sample in the tube to impregnate adjacent dry chemistry patches.
• a plastic film wrap is pre-shrunk over the tube and the patches so as not to allow specimen fluids to escape beyond the patches.
• 5,119,830 to Davis has a lid with outer and inner partitions to define a test space therebetween in which a chemical test strip is mounted.
• a fluid specimen in a cup is selectively introduced to the chemical test strip by manipulating a frangible valve which breaks an opening in the inner partition.
• the analytical specimen cup described in patent 5,119,830 to Davis allows technicians to control when fluid specimen is introduced to a chemical test strip so that the technicians need only do this when they are prepared to read and record the data.
• a lid of an analytical specimen cup system has outer and inner partitions defining a test space in which a chemical test strip is mounted with the inner partition defining: a raised test-strip holder on which the chemical test strip is mounted, a lower sump having a floor position substantially below the raised test-strip holder for receiving and retaining test fluid which drains downwardly from the raised test-strip holder, and an opening-defining member for selectively defining an opening for allowing test fluid to be transferred from a cup interior space into the test space but not allowing it to return to the cup interior space.
• the opening- defining member defines an upper mouth of the opening positioned vertically intermediate the raised test-strip holder and the sump floor.
• An analytical specimen cup for this system can be fitted with a membrane across a top thereof so that the cup can be separately sterilized.
• the lid includes a specimen release device for selectively piercing the membrane when the lid is on the specimen cup.
• Figure 1 is a schematic isometric view of an analytical specimen cup system of this invention
• Fig. 2 is a fragmented exploded view of the system of Figure 1 taken on line II-II in Fig. 1 with a peel-off label being partially removed for illustrative purposes; and
• Fig. 3 is a view similar to Fig. 2, but with the lid not being exploded from the specimen cup, rather being mounted thereon, and with the lid having a slightly modified structure of an embellished embodiment. DESCRIPTION OF THE PREFERRED EMBODIMENTS
• An analytical specimen cup system 10 of this invention comprises a specimen cup 12 and a specimen-cup r lid 14. Looking at Fig. 2, the specimen cup, or base container, 12 has a wall 16 for defining a container mouth
• the container mouth 18 is surrounded by external ribs or threads 20 which mesh with internal grooves or threads 22 of the lid 14.
• the container mouth 18 of the specimen cup 12 is covered by a thin membrane 24, such as a plastic or metallic membrane, which is sealably adhered to an end 26 and an outer surface 27 of the wall 16 so as to stretch across the container mouth 18 and seal the specimen cup 12 against contamination.
• the specimen cup 12, with its membrane 24, can be sterilized separately from the lid 14, with the membrane 24 ensuring that a cup interior space 25 of the specimen cup 12 remains sterilized, at least until the membrane 24 is pierced.
• the lid 14 comprises a lid main member 28 with a dry chemical test strip 30 and a thin transparent sheet of plastic 32 adhered thereto.
• Such a plastic film may be comprised of a single adhesible material, such as mylar, or may be of other materials, polyethylene, laminates or other substances which may be adhered, glued, heat-sealed, R-F sealed or otherwise sealably connected to the surface of the main member 28.
• the lid main member 28 has the internal grooves or threads 22 on an inner surface of a skirt 34 thereof.
• the lid 14 also includes a pressure-sensitive-peel-off-label color- analysis chart 36 which is adhered to the lid main member 28 beside or over the thin sheet of plastic 32 and the test strip 30.
• a portion of the lid main member 28 forms an inner partition 40 while the thin sheet of plastic 32 forms an outer partition 42; with the inner and outer partitions 40 and 42 defining a test space 44 therebetween.
• the test strip 30 is positioned in the test space 44.
• the test space 44 is separated from the cup interior space 25 of the specimen cup 12 on which the lid is mounted by the inner partition 40.
• the outer partition 42 is transparent for allowing the user to see into the test space 44.
• the inner partition 40 includes a tubularly- shaped, snorkel-like, opening-defining member 48 for defining an opening 50 for allowing test fluid to be transferred from the cup interior space 25 into the test space 44.
• a specimen release device 52 Positioned in the opening 50 is a specimen release device 52 which is molded as one piece with the inner partition 40, which is, in turn, integral with the lid main member 28.
• the specimen release device 52 is attached to the rest of the inner partition 40 at a circular frangible connection 54 which can be broken by downward pressure, in a direction of an arrow 56 on the top of the specimen release device 52.
• the specimen release device 52 has at a bottom end thereof one or more sharp teeth 58 which can cut into the membrane 24 extending across the container mouth 18 when the specimen release device 52 is pressed downwardly.
• the opening-defining member 48 defines an upper mouth 60 of the opening 50 which is vertically positioned intermediate a raised shelf 61 on which the test strip 30 is mounted and a floor 62 of a sump 64 surrounding the opening-defining member 48.
• the opening mouth 60 is slightly below the raised shelf 61 and well above the floor 62 of the sump 64.
• the test strip 30 comprises a line of chemical patches 66, each of which changes to a degree of color indicative of a characteristic of the test fluid.
• one of the patches will change to a particular color, or shade of color, depending upon a pH level of the test fluid when it is contacted by the test fluid.
• the peel-off color-analysis chart 36 has lines 68 of color blocks 70 thereon, each line corresponding to one of the chemical patches 66.
• Each of the color blocks 70a in a line 68 has a color which is representative of a possible color that its respective chemical patch 66 can attain when it is contacted by the test fluid.
• a technician places a cross 72 on the color block 70 most closely representing the color of its associated chemical patch 66.
• the same is repeated for each line 68 of color blocks 70 for each of the chemical patches 66 to respectively indicate the pH level, protein, ketone, etc.
• the peel-off color-analysis chart can then be peeled off and placed into a permanent record to document the test.
• the lid 14 is manufactured separately from the specimen cup 12 and its membrane 24 so that the specimen cup 12 can be sterilized using standard methods of sterilization and covered, either before or after the sterilization, by the membrane 24 which protects the sterilization.
• the lid 14, by contrast, is manufactured in a "clean" environment and is not sterilized so that its test strip 30 is not affected by the sterilization process and therefore can provide accurate readings.
• a specimen cup system 10 can be stored and transported as a unit with the lid 14 mounted on the specimen cup 12 in such a manner that the membrane 24 protecting the sterilized specimen cup 12 is not broken thereby, as depicted in Fig. 3, until such an operation is desired.
• the lid is attached to the cup 12 then both are sterilized together, with the test strip 30, plastic 32, and label being applied afterwards in a "clean" environment.
• a technician desires to place a specimen in the analytical specimen cup system 10 he separates the lid 14 from the specimen cup 12 and forcefully pulls the membrane 24 from the container mouth 18 of the specimen cup 12. The specimen is then placed in the cup interior space 25. The membrane 24 is then again placed tightly over the container mouth 18 so as to ensure that no outside bacteria are introduced into the cup interior space 25 and the lid 14 is secured tightly onto the container mouth 18, thereby stretching the membrane 24, but not piercing it.
• the technician which would include a doctor, nurse, or the like
• the technician who collects the test fluid specimen is not the same technician who will analyze the specimen. Thus, there may be a period of time which elapses between the collection of the specimen and its analysis.
• test fluid When a technician wishes to analyze the specimen test fluid he depresses the top end of the specimen release device 52 by flexing the thin sheet of plastic 32 in a direction of the arrow 56 and thereby breaks the frangible connection 54 and also causes the sharp tooth 58 at the lower end of the specimen release device 52 to cut into the membrane 24. This clears the opening, or passage 50 so that test fluid can now be transferred from the cup interior space 25 into the test space 44.
• the analyzing technician then turns the analytical specimen cup system 10 upside down so that test fluid of the specimen will pass through the opening 50 into the test space 44. Gravity causes the test fluid to flow through the opening mouth 60 and come into contact with the test strip 30.
• test fluid in the test space 44 is limited so that the test fluid does not completely fill the test space 44. However, in any case, sufficient test fluid enters the test space to contact the test strip 30 on the raised shelf 61. Once the test fluid has stopped flowing from the cup interior space 25 to the test space 44 the technician again inverts the analytical specimen cup system 10 to a right-side-up position. When the technician does this, virtually all of the test fluid which has entered the test space 44 drains into the sump 64.
• this test fluid which entered the test space 44 is drained from the raised shelf and the test strip 30; however, it is not allowed to fall back into the cup interior space 25.
• the test strip 30 is exposed to air so that it can properly react to the specimen, changing colors to indicate characteristics of the specimen.
• the fluid which has flowed into the test space 44 of the clean but unsterilized lid 14 is not allowed to contaminate the fluid specimen remaining in the cup interior space 25.
• the technician then appropriately marks the peel-off color-analysis chart 36 according to the colors of the patches on the test strip 30 and removes the peel- off color-analysis chart 36 from the analytical specimen cup system 10 and places it on the patient's chart.
• the analytical specimen cup system of this invention and the method of its use allow the specimen cup 12 to be sterilized and to remain sealed until it is used.
• a further benefit of the system and method of this invention is that it ensures that the test strip does not remain in continuous contact with the test fluid for a long period of time after the test fluid is introduced to the test strip.
• Fig. 3 depicts, for example, an embellishment of this invention in which a portion of the lid main member 28 is integrally formed as an optical magnifying lens 74 for making it easier for a technician to read the patches of the test strip.
• an optical magnifying lens 74 for making it easier for a technician to read the patches of the test strip.
• the hole created by the needle passing through this sampling zone 100 is small enough that fluid cannot easily escape therethrough, thereby preventing contamination of and from the laboratory surroundings after the sampling zone 100 is punctured.
• the sump 64 could have various configurations as could the opening-defining member 48. Further, it is not essential that the raised shelf have the exact configuration depicted in Figs. 2 and 3. In this regard, in one embodiment the raised shelf is at an angle to the horizontal so as to achieve better drainage.
• the specimen release device 52 is adherently connected to the plastic 32 to prevent its loss into the cup interior space 25 upon puncturing the frangible zone 50.
• the membrane 44 is omitted, where it is not necessary that the analytical specimen cup system be sterile (such as in a doctor's office where the system will be immediately disposed of after its use) .
• the specimen release device 52 is not sealingly connected to the rest of the lid, but rather is simply slidably connected thereto for piercing the membrane.
• the specimen release device 52 could be a simple valve.
• the lens 74 could be manufactured separately of a different material and snapped or adhered into place.
• sampling zone 100 could be made of a latex or other elastomeric material which would totally seal after needle withdrawal.

Landscapes

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

Applications Claiming Priority (1)

Publications (2)

Family

ID=22254903

Family Applications (1)

Country Status (3)

Families Citing this family (9)

Citations (4)

• 1996
  • 1996-03-27 WO PCT/US1996/004275 patent/WO1997035512A1/en not_active Application Discontinuation
  • 1996-03-27 JP JP09534348A patent/JP2001501725A/ja not_active Ceased
  • 1996-03-27 EP EP96912491A patent/EP0891150A4/de not_active Withdrawn

Patent Citations (4)

Non-Patent Citations (1)

Also Published As

Similar Documents

Legal Events