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WO1990001695A1 - Indicateur de gaz carbonique - Google Patents

Indicateur de gaz carbonique Download PDF

Info

Publication number
WO1990001695A1
WO1990001695A1 PCT/US1989/003065 US8903065W WO9001695A1 WO 1990001695 A1 WO1990001695 A1 WO 1990001695A1 US 8903065 W US8903065 W US 8903065W WO 9001695 A1 WO9001695 A1 WO 9001695A1
Authority
WO
WIPO (PCT)
Prior art keywords
indicator
matrix
methacrylate
methyl chloride
color
Prior art date
Application number
PCT/US1989/003065
Other languages
English (en)
Inventor
Samuel D. Riccitelli
John F. Goodman
Neil Dunski
Original Assignee
Mallinckrodt, Inc.
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 Mallinckrodt, Inc. filed Critical Mallinckrodt, Inc.
Publication of WO1990001695A1 publication Critical patent/WO1990001695A1/fr

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/84—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving inorganic compounds or pH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N31/00—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
    • G01N31/22—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators
    • G01N31/221—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators for investigating pH value
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0411—Special features for tracheal tubes not otherwise provided for with means for differentiating between oesophageal and tracheal intubation
    • A61M2016/0413—Special features for tracheal tubes not otherwise provided for with means for differentiating between oesophageal and tracheal intubation with detectors of CO2 in exhaled gases

Definitions

  • This invention relates to an indicator device, more particularly a rapid response device for the detection of carbon dioxide in a gas mixture.
  • U.S. Patent No. 2,890,177 discloses a liquid chemical indicator for detecting the presence of carbon dioxide in respiratory gases comprising an aqueous solution of an alkali metal oxalate and a pH sensitive dye which changes color at a pH in the range of 6.6 to 5.8
  • an endotracheal catheter also known as an intratracheal catheter
  • an intratracheal catheter may be used for general anesthesia; in the field, a doctor or paramedic may use an endotracheal catheter to resuscitate an apneic patient.
  • the detector includes a housing and an indicator in the form of a transparent disc which covers an aperture in the housing.
  • the disc has a chemical substance which provides a color change indication when exposed to carbon dioxide from the patient.
  • the device in Fehder comprises an enclosure defined by walls and having a transparent window in a wall, an inlet, an outlet and sealing means, the enclosure having mounted therein an indicator component adapted to be viewed through said transparent window.
  • the component comprises a carrier having attached thereto an indicating element formed from (1) an aqueous solution of a colorless compound, i.e., a base, which provides an alkaline solution; (2) a hygroscopic, high boiling, transparent, colorless, water-miscible liquid; and (3) a chemogenic pH- sensitive indicator which changes color relative to a change in pH of the solution and which has a pH which is lower by 1.0-1.5 pH units than the pH of the solution.
  • a colorless compound i.e., a base
  • a hygroscopic, high boiling, transparent, colorless, water-miscible liquid which changes color relative to a change in pH of the solution and which has a pH which is lower by 1.0-1.5 pH units than the pH of the solution.
  • a carrier particularly preferred by Fehder is a thin layer of bibulous material, such as filter paper or fibrous synthetic material, and the indicating component is formed by impregnating the bibulous material with the indicating element and drying to remove excess moisture.
  • a carbon dioxide indicator comprises a pH-sensitive dye present in a polymeric matrix.
  • the indicator does not rapidly change color when exposed to ambient air, but does rapidly change color when exposed directly to air exhaled from a human. Such color change upon exposure to exhaled air is at least fifty times faster than when exposed merely to normal ambient air.
  • the invention also provides a carbon dioxide indicator device employing the indicator and methods of making such a device.
  • the device is designed so that the color change of the indicator is viewable from outside the device.
  • the device may be a separate piece which is a part of an endotracheal tube circuit or applied to a portion of the inner surface of an endotracheal tube.
  • Figure 1 shows a partially exploded, cross- sectional view of one embodiment of the invention showing two possible locations of C0 2 indicator material.
  • Figure 2 shows a partially exploded, cross- sectional view of a second embodiment of the invention.
  • Figure 3 schematically illustrates a heat/moisture exchanger for a respiratory circuit, containing a pH indicating material in accordance with a third embodiment of the invention.
  • Figure 6 shows a perspective view of a fifth embodiment of the invention.
  • Figure 7 shows a cross-sectional view of the embodiment shown in Figure 6.
  • Ambient concentration levels of carbon dioxide in the esophagus are generally about equal to normal ambient air, i.e., less than about 1 mm Hg. In contrast, concentrations of carbon dioxide in expired breath typically range between about 30 and 40 mm Hg.
  • the indicator dye does not rapidly change color when exposed to the C0 2 levels present in normal ambient air, or upon exposure to the low C0 2 levels that might occur in the esophagus. In particularly preferred embodiments, the dye does not substantially respond to C0 2 present in ambient air for hours, days, weeks, months, or even years of continuous exposure. According to the invention, the indicator dye changes color at least about 50 times faster when directly exposed to exhaled air than when exposed to normal ambient air.
  • the dye rapidly changes color when exposed to only one or two breaths of exhaled air, containing, for example, as little as 15 mm of Hg of carbon dioxide (approximately 2% C0 2 ) .
  • the present invention can provide a rapid color change with only one exhaled breath of a patient.
  • o-cresolphthalein complexon sodium salt is purple-red (dry) or red (wet).
  • the dye turns clear.
  • the polymer matrix of the present invention is predominantly hydrophilic, with an optional hydrophobic portion.
  • the polymeric matrix includes a hydrophobic alkyl methacrylate in which the alkyl contains from one to about twelve carbon atoms.
  • the matrix contains, a mixture of alkyl methacrylates having alkyl portions containing from about one to twelve carbon atoms.
  • the hydrophilic portion of the matrix is an alkyl halide quaternary salt of an alkyl methacrylate, such as the methyl chloride quaternary salt of dimethylaminoethyl methacrylate.
  • the matrix of the present invention has been found to be quite ef icient in capturing water from expired breath, and also facilitates the achievement of a proper pH environment around the dye.
  • a hydrophobic monomer when a hydrophobic monomer is used in the matrix, less than about 30% of the monomers utilized are hydrophobic, the remaining monomers being hydrophilic so that the matrix as a whole is predominantly hydrophilic.
  • the matrix of the present invention also improves the reversal time of the indicator dye, i.e., the amount of time that the indicator takes to change back to its original color from its indicating color (or lack of color) when the indicator is no longer exposed to C0 2 .
  • the reversal time of the indicator dye is dependent on, among other things, the ratio of polymer to dye. In general, the greater the polymer to dye ratio, the slower the reversal time. With higher polymer/dye ratios, the reversal time can be as much as 5-15 minutes, while with smaller ratios the reversal time can be as short as 5-10 seconds.
  • a solid desiccant such as CaCl 2 or MgS0 4 may be incorporated into the matrix.
  • a desiccant may serve to reduce the breath response time by improving the efficiency of the matrix at removing water from expired breath.
  • calcium dyes such as o-cresolphthalein complexon sodium salt
  • the use of a calcium salt as a desiccant may increase the vividness of the color in the resting, non-indicating state of the indicator.
  • Basic salts such as sodium hydroxide, potassium phosphate, trisodium phosphate, and the like, have been found to enhance color when present in the matrix.
  • methanol is also added as a diluent.
  • the solution is then spin-coated onto a 15 mm connector and then exposed to UV radiation.
  • the polymerization and cross-linking both take place simultaneously on the connector surface.
  • the process lends itself to a highly manufacturable indicator.
  • the coating is insoluble and therefore easily sterilizable by ethylene oxide.
  • plastics are polyacrylonitrile/methacrylate (Barex 210, manufactured by Sohio), acrylic multipolymers such as G-20 (Cyro Industries), XT-800 (Cyro Industries), NAS (Richardson Polymer Corporation), and RSA-3G (Richardson Polymer Corporation) . These polymers are particularly preferred because they contain methacrylate based polymers which increase the adherence of the matrix to the connector.
  • FIG. 3 shows another embodiment wherein a heat/moisture exchanger for a respiratory circuit includes a transparent housing 26 that contains a matrix material 220 having an indicator dye present therein that changes color when exposed to exhaled C0 2 .
  • the indicator was applied to 15 mm connectors fashioned from various transparent materials in surface concentrations of 0.05 - 0.10 cc/cm 2 .
  • the matrix responded in 1 - 3 breaths (pale blue to clear) and reversed in less than 5 seconds.
  • the matrix cured in ⁇ 4 minutes (heat applied as in Example II). Although the response of the indicator was good, due to the minimal presence of hydrogel, the matrix was highly water soluble and therefore would begin to wash away after 50 breathing cycles.
  • the indicator was applied in surface concentrations of 0.06 cc/cm 2 .
  • the color changed from purple-blue to clear in 1 breath and recovered in 20 seconds.
  • the matrix cured in ⁇ 3 minutes. As a result of the greater polymer concentration the matrix was not as susceptible to water solubility.
  • the matrix was applied to 15 mm connectors in surface concentrations of 0.05 cc/cm 2 .
  • the indicator responded to a water saturated gas stream containing 2% C0 2 (at a flow rate ⁇ 2 liters/minute and at a temperature of 35°C) in 5 seconds (changed from purple- blue to clear) .
  • the indicator recovered in ⁇ 15 seconds.
  • the matrix cured in ⁇ 1.5 minutes.
  • MMA methyl methacrylate
  • LMA lauryl methacrylate

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Analytical Chemistry (AREA)
  • Pathology (AREA)
  • Pulmonology (AREA)
  • Urology & Nephrology (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Physics & Mathematics (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Microbiology (AREA)
  • Otolaryngology (AREA)
  • Medicinal Chemistry (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Emergency Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Investigating Or Analyzing Non-Biological Materials By The Use Of Chemical Means (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Est décrit un indicateur de gaz carbonique s'utilisant pour déterminer le positionnement correct de tubes endotrachéaux. L'indicateur est constitué d'un colorant sensible au pH en suspension dans une matrice polymère à prédominance hydrophile. L'indicateur peut être placé à l'intérieur d'un tube ou d'un connecteur pour former un dispositif indicateur. Lorsque le colorant sensible au pH change de couleur par suite de la présence de CO2 et d'humidité dans l'air exhalé, le changement de couleur est visible de l'extérieur du dispositif.
PCT/US1989/003065 1988-07-29 1989-07-18 Indicateur de gaz carbonique WO1990001695A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US22575488A 1988-07-29 1988-07-29
US225,754 1988-07-29
US31800289A 1989-03-02 1989-03-02
US318,002 1989-03-02

Publications (1)

Publication Number Publication Date
WO1990001695A1 true WO1990001695A1 (fr) 1990-02-22

Family

ID=26919881

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1989/003065 WO1990001695A1 (fr) 1988-07-29 1989-07-18 Indicateur de gaz carbonique

Country Status (2)

Country Link
AU (1) AU3970289A (fr)
WO (1) WO1990001695A1 (fr)

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991005252A1 (fr) * 1989-09-29 1991-04-18 Abbey Biosystems Limited Detecteur de dioxyde de carbone
WO1997014464A1 (fr) * 1995-10-20 1997-04-24 Nellcor Puritan Bennett Incorporated Dispositif endotracheal a usage pediatrique
NL1004646C2 (nl) * 1996-11-29 1998-06-03 Buchem Holding B V Middelen voor het bepalen van de zuurtegraad van de urine van een kat.
US5881879A (en) * 1997-02-07 1999-03-16 Baxter International Inc. System for preserving and delivering gas-containing solutions
GB2341101A (en) * 1998-09-02 2000-03-08 Smiths Industries Plc A breathing indicator device
DE10025202A1 (de) * 2000-05-20 2001-11-29 Messer Austria Gmbh Gumpoldski Gasdosiergerät mit Katheter
US7992561B2 (en) 2006-09-25 2011-08-09 Nellcor Puritan Bennett Llc Carbon dioxide-sensing airway products and technique for using the same
US8396524B2 (en) 2006-09-27 2013-03-12 Covidien Lp Medical sensor and technique for using the same
US8420405B2 (en) 2006-09-25 2013-04-16 Covidien Lp Carbon dioxide detector having borosilicate substrate
US8431088B2 (en) 2006-09-25 2013-04-30 Covidien Lp Carbon dioxide detector having borosilicate substrate
US8431087B2 (en) 2006-09-25 2013-04-30 Covidien Lp Carbon dioxide detector having borosilicate substrate
US8449834B2 (en) 2006-09-25 2013-05-28 Covidien Lp Carbon dioxide detector having borosilicate substrate
CN109781716A (zh) * 2017-11-13 2019-05-21 塔能股份公司 气体指示器

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2683150B1 (fr) * 1991-10-30 1994-01-21 Robert Bezicot Nez artificiel pour sujet tracheotomise, avec un orifice chirurgical abouchant la trachee a la peau.

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0257916A1 (fr) * 1986-08-13 1988-03-02 Nellcor Incorporated Dispositif indicateur
US4790327A (en) * 1987-07-27 1988-12-13 George Despotis Endotracheal intubation device

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0257916A1 (fr) * 1986-08-13 1988-03-02 Nellcor Incorporated Dispositif indicateur
US4790327A (en) * 1987-07-27 1988-12-13 George Despotis Endotracheal intubation device

Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991005252A1 (fr) * 1989-09-29 1991-04-18 Abbey Biosystems Limited Detecteur de dioxyde de carbone
US5472668A (en) * 1989-09-29 1995-12-05 Abbey Biosystems Limited Carbon dioxide monitor
WO1997014464A1 (fr) * 1995-10-20 1997-04-24 Nellcor Puritan Bennett Incorporated Dispositif endotracheal a usage pediatrique
NL1004646C2 (nl) * 1996-11-29 1998-06-03 Buchem Holding B V Middelen voor het bepalen van de zuurtegraad van de urine van een kat.
WO1998023966A1 (fr) * 1996-11-29 1998-06-04 Buchem Holding B.V. Systeme permettant de mesurer le taux d'acidite de l'urine d'un chat
US5881879A (en) * 1997-02-07 1999-03-16 Baxter International Inc. System for preserving and delivering gas-containing solutions
DE19940160B4 (de) * 1998-09-02 2008-01-17 Smiths Group Plc Luftröhrenkatheteranordnung mit einer Anzeigevorrichtung
US6378522B1 (en) 1998-09-02 2002-04-30 Smiths Industries Public Limited Respiration assemblies and indicators
GB2341101B (en) * 1998-09-02 2003-01-22 Smiths Industries Plc Respiration assemblies and indicators
GB2341101A (en) * 1998-09-02 2000-03-08 Smiths Industries Plc A breathing indicator device
DE10025202A1 (de) * 2000-05-20 2001-11-29 Messer Austria Gmbh Gumpoldski Gasdosiergerät mit Katheter
US8128574B2 (en) 2006-09-25 2012-03-06 Nellcor Puritan Bennett Llc Carbon dioxide-sensing airway products and technique for using the same
US8109272B2 (en) 2006-09-25 2012-02-07 Nellcor Puritan Bennett Llc Carbon dioxide-sensing airway products and technique for using the same
US7992561B2 (en) 2006-09-25 2011-08-09 Nellcor Puritan Bennett Llc Carbon dioxide-sensing airway products and technique for using the same
US8420405B2 (en) 2006-09-25 2013-04-16 Covidien Lp Carbon dioxide detector having borosilicate substrate
US8431088B2 (en) 2006-09-25 2013-04-30 Covidien Lp Carbon dioxide detector having borosilicate substrate
US8431087B2 (en) 2006-09-25 2013-04-30 Covidien Lp Carbon dioxide detector having borosilicate substrate
US8449834B2 (en) 2006-09-25 2013-05-28 Covidien Lp Carbon dioxide detector having borosilicate substrate
US8454526B2 (en) 2006-09-25 2013-06-04 Covidien Lp Carbon dioxide-sensing airway products and technique for using the same
US8396524B2 (en) 2006-09-27 2013-03-12 Covidien Lp Medical sensor and technique for using the same
CN109781716A (zh) * 2017-11-13 2019-05-21 塔能股份公司 气体指示器

Also Published As

Publication number Publication date
AU3970289A (en) 1990-03-05

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