US3925163A - Diagnostic device - Google Patents

Diagnostic device Download PDF

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Publication number
US3925163A
US3925163A US400080A US40008073A US3925163A US 3925163 A US3925163 A US 3925163A US 400080 A US400080 A US 400080A US 40008073 A US40008073 A US 40008073A US 3925163 A US3925163 A US 3925163A
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US
United States
Prior art keywords
innoculation
media
compartments
tubular member
compartment
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
US400080A
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English (en)
Inventor
Jr Thomas Cekoric
Patrick Michael Yananton
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Hoffmann La Roche Inc
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F Hoffmann La Roche AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by F Hoffmann La Roche AG filed Critical F Hoffmann La Roche AG
Priority to US400080A priority Critical patent/US3925163A/en
Publication of USB400080I5 publication Critical patent/USB400080I5/en
Application granted granted Critical
Publication of US3925163A publication Critical patent/US3925163A/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12MAPPARATUS 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
    • C12M41/00Means for regulation, monitoring, measurement or control, e.g. flow regulation
    • C12M41/30Means for regulation, monitoring, measurement or control, e.g. flow regulation of concentration
    • C12M41/34Means for regulation, monitoring, measurement or control, e.g. flow regulation of concentration of gas
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12MAPPARATUS 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
    • C12M23/00Constructional details, e.g. recesses, hinges
    • C12M23/34Internal compartments or partitions
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12MAPPARATUS 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
    • C12M41/00Means for regulation, monitoring, measurement or control, e.g. flow regulation
    • C12M41/30Means for regulation, monitoring, measurement or control, e.g. flow regulation of concentration
    • C12M41/36Means for regulation, monitoring, measurement or control, e.g. flow regulation of concentration of biomass, e.g. colony counters or by turbidity measurements
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00Chemistry: molecular biology and microbiology
    • Y10S435/801Anerobic cultivation
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00Chemistry: molecular biology and microbiology
    • Y10S435/8215Microorganisms
    • Y10S435/822Microorganisms using bacteria or actinomycetales
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00Chemistry: molecular biology and microbiology
    • Y10S435/8215Microorganisms
    • Y10S435/822Microorganisms using bacteria or actinomycetales
    • Y10S435/842Clostridium
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00Chemistry: molecular biology and microbiology
    • Y10S435/8215Microorganisms
    • Y10S435/822Microorganisms using bacteria or actinomycetales
    • Y10S435/874Pseudomonas

Definitions

  • DIAGNOSTIC DEVICE [75] Inventors: Thomas Cekoric, Jr., Hopatcong;
  • the present invention relates to an improved device for determining the presence of bacteria in a specimen sample.
  • Disposable diagnostic devices comprising several media-containing compartments and a wire rod extending through said compartments are known.
  • each compartment contains a conventional test medium which is suitable for determining the biochemical characteristics of an organism.
  • one end of the rod is brought into contact with isolates obtained from a specimen sample which may be sputa, blood and the like.
  • the innoculation rod is then drawn through the various compartments so that any microorganisms contained on the said one end is a source of innoculum for the test media.
  • test media which perform better under anaerobic conditions are affected by exposure to air. Air may enter prior art devices via the space formerly occupied by the innoculation rod after it is withdrawn and/or may be present in the space above the media in the compartment in which it is contained.
  • a scored innoculation wire rod is provided. Upon severing the innoculation rod at its scored portion, the portion so severed can be reinserted into those compartments which contain media adversly affected by aerobic conditions. Thereby, the entry of air into such compartments is limited.
  • the overlay preferably a wax-overlay in cooperation with the scored portion can further assure the efficaciousness of media which performs better under anaerobic conditions.
  • FIG. 1 is a side view of a disposable diagnostic de vice.
  • FIG. 2 is a view of the elongated innoculation instru ment.
  • FIG. 3 is a view of the device after innoculation.
  • FIG. 4 illustrates an alternate rigid member utilizable for the purposes of the present invention.
  • the disposable diagnostic device is illustrated.
  • the device comprises a tubular member 2 made of clear plastic.
  • the ends of the tubular member are secured to screw-type caps 3 and 4.
  • the tubular member is shown as being divided into eight compartments for receiving culture media indicated by dotted line. It is, of course, to be understood that the tubular member can comprise more or less than eight compartments. Regardless of the number of compartments, each will contain a different culture media known to determine the presence of a particular organism.
  • each of the walls which define the compartments there is provided an opening.
  • Each of said openings are axially aligned whereby they can slidably receive a rod or wire member 5.
  • One end of the rod member 5 projects from one end of the tubular member and is provided with an innoculation means 6 which may be the end of the rod member 5.
  • the other end of the rod member 5 projects from the other end of the tubular member 2 and is provided with a handle means 7.
  • the rod member 5 is provided with a scored portion 8.
  • the innoculation means 6 is contacted with isolates obtained, for example, from urine, sputa and the like. After such contact, the handle means 7 is grasped bythe user and the rod member 5 is pulled through the tubular member. As the innoculation means 6 passes through the compartments, it innoculates the media contained therein. After a suitable period, the container is visably examined for biochemical changes, evidenced by changes in characteristics of the media, eg change of color of the medium. Evidence of biochemical changes provides diagnostically significant information.
  • the disposable device contains media such as dextrose, lysine or ornithine or similer type media in compartments 10, 11 and 12.
  • media such as dextrose, lysine or ornithine or similer type media in compartments 10, 11 and 12.
  • the biochemical process occurs preferably in such type media under anaerobic conditions.
  • Compartments 10, 11 and 12 are disposed sequentially at the end of the device adjacent the handle means 7 and are each covered by a wax overlay 18.
  • the innoculation end 6 of rod member 5 is then reinserted into the tubular member 2.
  • the rod member 5 enters tubular member 2 via the centrally disposed openings contained in the compartment walls until its tip 9 passes into compartment 13.
  • Compartment 13 does not contain a media which is adversely affected by aerobic conditions, whereas as indicated above compartments 10, 11 and 12 do.
  • the scored portion is about adjacent the outer wall of compartment 10.
  • Rod member 5 is then broken at the scored portion.
  • the portion of the rod member 5 from the scored portion to the handle means 7 is discarded.
  • the remaining portion of the rod member 5 is now positioned in the openings in the walls which define compartments 10, 11 and 12 as seen in FIG. 3.
  • the openings in the walls defining compartments 10, 11 and 12 are closed.
  • the improved device of the present invention provides a simple, reliable and rapid method for the identification of organisms, particularly, organisms of the Gram-negative bacteria of the family Enterobacteriaceae which is characteristic of prior art devices and yet improves upon the prior art devices in that it avoids the problems inherent in the use of anaerobic tes media in the prior art devices.
  • the culture media found in the various compartments of the device may be selected from among the many suitable for the purposes of the present invention by a person skilled in the art.
  • test media All that is required of the test media is that it be a nutrient media which when innoculated with a particular type of bacteria undergoes chemical changes which can be observed via the transparent compartment case.
  • a typical device will contain the following media: dextrosetcompartment lysine (11) and omithine (12) which biochemically react, preferably, in the absence of air.
  • the device may also contain H S-indole in compartment 13; lactose (14), PA-Dalcitol (15), urea (16), citrate (17) or any suitable medium in any suitable number of compartments which biochemically react in the presence of air.
  • the score provided in rod member 5 provides a convenient means of insuring that media changes not be effected by aerobic conditions.
  • one of the advantages of the present invention is in the use of an innoculation rod that is scored and hence breakable, which innoculation rod can be broken and a portion thereof can be reinserted into the device to lessen the possibility of air entering those compartments which contain media, the biochemical changes of which would be adversely affected by the presence of air.
  • a protecting layer may be positioned thereon and in a preferred embodiment, a wax overlay is utilized.
  • the wax overlay overlies the media completely in the compartment and hence engages all of the four walls which define same.
  • a wax is preferred for the purposes of providing the overlay material, it is, of course, to be understood that other materials can also be efficaciously utilized.
  • other materials suitable for the purposes of the present invention can be included petroleum distillates such as vasoline, cosmoline and the like.
  • the overlay material should be pliable, should cover the media completely, should be non-porous and if a wax, should free flow above about 65C. and be solid below about 50C.
  • the reinsertable portion can be between the handle 7 and the scored portion.
  • the rod 5 is removed, broken and then the portion containing the handle end is reinserted in the device. It is, of course, to be understood that in this embodiment, the portion between the handle end and the scored portion will be slightly greater than the sum of the distances between the walls which define compartments 10, 11 and 12.
  • the scored portion on the rod member may be eliminated and a separate rod as seen in FIG. 4 can be provided for reinsertion into the tubular member.
  • compartments containing 3 anaerobic and 5 aerobic materials have been illustrated, it is, of course to be understood, that more or less than eight compartments can be employed and more or less than three anaerobic media can be utilized. All that is required to accommodate any such modification is that the scored portion on rod 5 be so-situated thereon that when rod 5 is broken, the broken portion will pass through all the walls defining the compartments containing anaerobic" media (preferably coated with a 4 wax overlay) and will not pass completely through a compartment containing aerobic media.
  • a method for innoculating and insuring the biochemical reaction of a test media contained in compartments of a tubular member of a disposable diagnostic device said disposable device including an innoculation member extending longitudinally through the tubular member via axially aligned openings contained in the walls which define said compartments, said innoculation member including a handle end and an innoculation end; at least one of such compartments containing a media which biochemically reacts under anaerobic conditions, any such last-mentioned compartment being disposed sequentially adjacent to one end of the tubular member which 'method comprises contacting said innoculation end with isolates obtained from a specimen sample, pulling on said handle end whereby said innoculation member is withdrawn from said tubular member and said innoculation end passes through and hence, contacts all of said test media and permits air to enter the tubular member through the compartment adjacent the inoculation end and reinserting an insertable member into the openings in the walls of any compartment that contain a medium which biochemically reacts under anaerobic
  • a method as in claim 1 which comprises coating any media which biochemically reacts under anaerobic conditions with a non-porous, pliable material which is solid below 50C.
  • a method as in claim 2 wherein the material coated on the media is wax.
  • innoculation member is provided with a scored portion and the innoculation member is broken at the scored portion after said innoculation member is withdrawn from the tubular member and utilizing one of said broken portions as the said insertable member.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Wood Science & Technology (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
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  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Biotechnology (AREA)
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  • General Engineering & Computer Science (AREA)
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  • Analytical Chemistry (AREA)
  • Immunology (AREA)
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  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
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  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
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US400080A 1972-05-25 1973-09-24 Diagnostic device Expired - Lifetime US3925163A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US400080A US3925163A (en) 1972-05-25 1973-09-24 Diagnostic device

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US25698472A 1972-05-25 1972-05-25
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US3925163A true US3925163A (en) 1975-12-09

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4187351A (en) * 1977-11-25 1980-02-05 The United States Of America As Represented By The Secretary Of The Army IMViC test method
WO1991007503A1 (en) * 1989-11-13 1991-05-30 International Health Services Method and system for detecting and culturing microorganisms
FR2751342A1 (fr) * 1996-07-22 1998-01-23 Int Microbio Dispositif et son mode d'utilisation pour prelever a partir de colonies bacteriennes ou fongiques presentes sur un milieu de culture gelose, une quantite reproductible de germes

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3205151A (en) * 1962-04-17 1965-09-07 Hollister Inc Inoculation device and method

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3205151A (en) * 1962-04-17 1965-09-07 Hollister Inc Inoculation device and method

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
Enterotube Pamphlet, Hoffmann-LaRoche Inc., April 1970 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4187351A (en) * 1977-11-25 1980-02-05 The United States Of America As Represented By The Secretary Of The Army IMViC test method
WO1991007503A1 (en) * 1989-11-13 1991-05-30 International Health Services Method and system for detecting and culturing microorganisms
FR2751342A1 (fr) * 1996-07-22 1998-01-23 Int Microbio Dispositif et son mode d'utilisation pour prelever a partir de colonies bacteriennes ou fongiques presentes sur un milieu de culture gelose, une quantite reproductible de germes

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USB400080I5 (ja) 1975-01-28

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