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
  • G01N33/98—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving alcohol, e.g. ethanol in breath

Definitions

• the present invention relates generally to devices for measuring alcohol content of gasses and, more particularly, to a portable, pocketsize, disposable breath analyzer device for determining the blood alcohol content of a user's breath sample blown through the device.
• a portable, pocketsize, disposable breath analyzer device for determining the blood alcohol content of a user's breath sample blown through the device.
• blood sample analysis although being typically accurate, necessarily requires an invasion or intrusion into the body of an individual which thereby prohibits its use for self-evaluation by individuals and additionally raises constitutional concerns for use by law enforcement personnel.
• breath sample analysis correlates the amount of alcohol in the user's breath sample with the amount of alcohol in the same user's blood.
• potassium dichromate impregnated silica gel provides a suitable visual color indication of the amount of alcohol contained in the user's breath sample, it readily reacts with oxygen such as that contained in air and water and, therefore, poses a substantial safety hazard to a user if accidentally back aspirated or inhaled into a user's lungs or comes in contact with the user's skin. Further, potassium dichromate impregnated silica gel has been found to additionally react to organic compounds, ketones, esters, and peroxides such as those typically found in modern polymeric compounds .
• OMPI and impact strength of glass is limited which has caused concerns as to breakage of the glass housings for such analyzer devices and possible exposure of the users to the highly reactive and dangerous potassium dichromate silica gel compound.
• the present invention specifically addresses and alleviates the above-referenced needs in the art by providing a pocketsized disposable breath analyzer device formed of a high impact strength polymeric compound which is inert with respect to potassium dichromate impregnated silica gel contained within the device adapted to provide a visual color indication of the amount of alcohol contained in a user's breath sample blown through the device. More particularly, the present invention discloses a novel structure, polymeric housing material and method of fabrication of a disposable breath analyzer device which provides user safety in operation and insures prolonged shelf-life of the device.
• the device is formed having a tubular polymeric housing having an end portion formed to be placed in the mouth of a user and central portion which carries a quantity of colorimetric chemical material, more particularly potassium dichromate impregnated silica gel.
• the particular polymeric compound utilized for the housing material is characterized by high impact strength and which is completely devoid of any organic compounds such as internal mold release agents as well as ketones, esters, and peroxides.
• no organic mold or part release agents are applied to the tooling, thereby insuring that the final housing components will remain inert with respect to the potassium dichromate impregnated silica gel colorimetric compound.
• the present invention additionally incorporates a pair of valve members positioned on opposite sides of the colorimetric material adapted to prevent any back aspiration of air from the colorimetric compound into the user's lungs. Further, these valve members in their normally closed position, prevent any accidental entrance of air, moisture or the like into the chemical bed prior to use of the device for analysis purposes.
• the present invention additionally discloses ' a novel method of fabricating and assembling the breath analyzer device in a manner to insure that the colorimetric material is purged of any moisture or air during insertion into the housing of the device and subsequently maintained in a hermetically sealed environment so as to prolong useful shelf life.
• Figure 1 is a perspective view of the disposable breath analyzer device of the present invention
• Figure 2 is an exploded perspective view of the breath analyzer device of the present invention with its end caps removed;
• TM Figure 3 is a cross-sectional view of the disposable breath analyzer device of the present invention with its end caps removed;
• Figure 4 is a perspective view of one of the screens disposed within ' the interior of the breath analyzer device of the present invention.
• Figure 5 is a perspective view showing the construction and operation of the valving members utilized in the disposable breath analyzer of the present invention.
• Figure 6 is a fragmentary perspective view of the housing of the breath analyzer device of the present invention.
• Figures 7 through 12 are schemetic views depicting the sequential steps in the method of assembling the disposable breath analyzer device of the present invention.
• Figure 13 is a perspective view of the packaged disposable breath analyzer of the present invention. Detailed Description of the Preferred Embodiment
• the disposable breath analyzer device 10 of the present invention composed of a housing designated generally by the numeral 12, a chemical bed sleeve 14, and a pair of end caps 16 and 18.
• the housing 12 is formed by a cylindrical main body portion 20 and mouthpiece portion
• Both the main body portion 20 and mouth piece portion 22 include axial apertures 24 and 26, respectively, with the axial aperture 24 terminating at the distal end 28 of the body portion 14 in a plurality of openings 30.
• a pair of rectangular openings or windows 32 are additionally provided in the main body portion 20 which extend radially through its cylindrical.
• the main body portion 12 additionally includes a locating shoulder 34 which extends radially inward within the interior of the aperture 24 adjacent the distal end 28.
• the rectangular windows 32 permit viewing within the interior of the housing 12 while the locating shoulder 34 serves to maintain the axial orientation of the chemical bed sleeve 14 within the main body portion 20.
• the chemical bed sleeve 14 preferably is formed in an elongate tubular configuration having a central aperture 40 extending therethrough and a registry shoulder 101 adjacent its distal end.
• the outside diameter of the chemical sleeve bed 14 is sized to be slightly less than the diameter of the central aperture 24 of the main body portion 20 and includes a pair of radially extending circumferential ribs 42.
• the diameter of the central aperture 40 of the chemical bed sleeve 14 is sized to be equal approximately to the diameter of the central aperture 26 of a mouth piece portion 22.
• the circumferential ribs 42 form a tight interference seal between the sleeve 14 and body portion 20 while the apertures 26 and 40 and openings 30 formed in the distal end 28 of the body portion 20 form a central flow passage through the housing 12.
• Each of the screens 50 are positioned within the interior of the chemical bed sleeve 14 at differing axial locations.
• Each of the screens 50 are formed in a generally cup-like configuration, the outside diameter of which is slightly greater than the diameter of the aperture 40 such that the screens are maintained in a slight interference fit within the aperture 40.
• a plurality of apertures 52 are provided in each of the screens 50, the size of which are designed to provide an
• indicating desiccant 60 colorimetric compounds 62 and nonindicating silica gel 64 is positioned between adjacent screens 50. As is well known, the indicating desiccant serves to remove water vapor from the breath sample blown through the device 10 while the nonindicating silica gel 64 serves to provide a color comparison basis.
• the colorimetric chemical compound 62 is characterized by its ability to scrub or absorb alcohol carried by a gas and upon absorption of the same, experience a visual color change.
• a potassium dichromate impregnated silica gel compound is utilized which by _ appropriate buffering by use of sodium bisulfate may have the particular absorption rate of alcohol be modified.
• the particular visual color derived during absorption may be modified.As will be recognized, the screens 50, although forming a barrier to migration of the desiccant 60 potassium dichromate impregnated silica gel 62 and nonindicating silica gel 64, permit unrestricted air flow through the aperture 40 of the chemical bed sleeve 14.
• a pair of valving members 7 Disposed adjacent opposite ends of the chemical bed sleeve 14 are a pair of valving members 7 which serve to permit gas flow through the housing 12 in only one direction, i.e. in the direction from the mouthpiece portion 22 toward the openings 30 in a distal end 28 of the housing 12.
• the valve members 70 are each formed by a pair of thin planer disks 72 and 74 which are sandwiched together so as to tightly abut one another.
• the disk 72 is formed having a central aperture 76 extending therethrough, the size of which is less than the diameter of the aperture 40 of the chemical bed 14.
• the disk 74 includes a C-shaped opening 78 extending therethrough which forms a disk-shaped cover portion 80 within its interior.
• the diameter of the cover portion 80 is sized to be greater than the diameter of the aperture 76 so that the cover portion 80 normally covers or blocks the aperture 76 formed in the disk member 72. Due to the cover portion 80 being retained to the disk 74 by only a small hinge-like tab 82, upon experiencing a pressure force being applied to the cover portion 80 from the direction of the aperture 76, the cover portion 80 is free to move from its full-line position to its phantom line position wherein flow through the aperture 76 and C-shaped opening 78 is permitted.
• a pressure force being applied to the cover member 80 in an opposite direction causes the cover member 80 to be pressed more tightly against the disk 72 and thereby prevent any flow through the aperture 76 and across the valve 70.
• the valving members 70 are positioned adjacent opposite ends of the chemical bed sleeve 14 and are oriented so that the cover portion 80 is on the downstream side of intended flow through the housing 12 thereby insuring that flow through the housing can only be accomplished in one direction away from the mouth piece portion 22.
• the end caps 16 and 18 are both formed having a generally cup-shaped configuration with the interior diameter 90 of the cap 18 being sized to be slightly less than the outside diameter of the distal end 28 of the housing 12 so that a slight interference fit exist to retain the cap 18 upon the distal end 28.
• the end cap 16 includes an axially extending tapered shank portion 92 which is sized to be received and seal against the distal portion of the aperture 26 formed within the mouth piece portion 22 of the housing 12.
• both of the end caps 16 and 18 are designed to remain upon the housing 12 during storage; however, may be easily readily removed from the housing 12 prior to use of the device 10 for analysis purposes.
• the housing 12, chemical bed sleeve 14, screens 50, and end caps 16 and 18 be formed of a material .inert to the potassium dichromate impregnated silica gel compound 60.
• this silica gel compound 60 posing a significant hazard to users, it is important that the particular material utilized for the housing 12 possesses sufficient impact sheer and tensile strength to positively prevent any accidental breakage during use.
• the particular material utilized for the housing components of the device 10 must additionally be capable of economical high production fabrication.
• polymeric compounds release esters which react with the potassium dichromate impregnated silica gel compound 60 and, hence, are unsuitable for use in the disposable breath analyzer 10.
• polymeric materials which include ketones, esters, and/or other organic compounds found in mold release agents additionally are highly reactive to potassium dichromate impregnated silica gel.
• the specific polymeric compound utilized in the present invention must be devoid of any organic compounds utilized for mold release agents, ketones, and esters.
• chemical compounds should have high impact capacity to be capable of withstanding impact strength requirements for such a device.
• the applicant has found that medical grade polycarbonate and/or polypropylene specifically manufactured without any organic mold release compounds, possess the necessary properties (i.e. does not contain organic compounds, ketones, esters, or peroxides) so as to be the preferred candidates for the application.
• polycarbonate and polypropylene polymeric materials may be economically fabricated by way of mass production extrusion and/or molding techniques.
• the main body portion 20, mouth piece portion 22, chemical bed sleeve 14, screen 50, valving members 70, and end caps 16 and 18 are all fabricated from polycarbonate material so as to insure user safety and prolong shelf life of the device 10.
• the above-referenced individual components of the device are extruded or molded or in some instances, vacuum formed, without the use of mold release agents such that they will remain inert to the potassium dichromate impregnated silica gel.
• the individual components are assembled by a novel method depicted in Figures 7 through 13.
• the initial step in the assembly method is depicted in Figure 7 wherein the chemical bed sleeve 14 is aligned in a vertical orientation and maintained in this orientation by cooperation of a suitable clamping means such as a caliber 100 extending within the registry recess or shoulder 101 formed adjacent the distal end of the chemical bed sleeve 14.
• a first screen 50A may then be inserted axially upward in the central aperture 40 of the chemical bed sleeve 14 from its phantom line position to its full line position.
• a quantity 64 of nonindicating silica gel may then be inserted from the upper end of the chemical bed sleeve 14 and the second screen 50B may be inserted axially downward within the aperture 40 from its phantom to full line position.
• the quantities 64 of nonindicating silica gel is maintained in precise axial orientation within the interior of the chemical bed sleeve 14.
• a quantity 62 of potassium dichromate impregnated silica gel may be inserted from the upper end of the chemical bed sleeve 14 with a third screen 50C being axially positioned within the aperture 40 in an analgous manner.
• a quantity of indicating desiccant 60 may additionally be inserted in the aperture 40 and the final screen 50D be inserted within the aperture 40.
• the outside diameter of the screens 50A through 50D being slightly greather than the inside diameter of the central aperture 40, when positioned in such a manner, the axial location of the quantities 60, 62, and 64 are maintained or fixed within the chemical bed sleeve 14.
• the placement of the quantities of gel 62 is accomplished in an extremely low humidity environment of approximately no greater than 30 percent or less than one percent relative humidity and additionally is accomplished in an extremely rapid process as by way of automated equipment.
• the main body portion 20 of the housing 12 is preferably registered in a vertical orientation and the first valving member 70A may be inserted within the central aperture 24 of the body portion 20 from its phantom line position to its full line position.
• the first valving member 70A is oriented such that its cover portion 80A is closer to the distal end 28 of the main body portion 20 then its central aperture 76A.
• the axial position of the first valving member 70A is located by abutment of the valving member 70A with the shoulder tab 34 formed adjacent the distal end 28 of the main body portion 20.
• the previously filled chemical bed sleeve 14 may be axially inserted within the interior of the aperture 24 to an axial position wherein its lowermost end directly abuts the valving member 70A. Due to the chemical bed sleeve 14 including the pair of circumferentially extending ribs 42 about its outside diameter, it will be recognized that when positioned within the main body portion 20, a seal is developed between the chemical bed sleeve 14 and main body portion 20. Subsequently, a second valving member 70B oriented in an analgous manner to the valving member 70A may be inserted within the the aperture 24 so as to directly abut the uppermost end of the chemical bed sleeve 14.
• the mouthpiece portion 22 of the housing 12 may be inserted within the aperture 24 to contact the second valving member 70B and is retained in position by either a laser weld or spin weld
• the entire assembly of the chemical bed sleeve 14 valving members 70 and housing portions 20 and 22 is accomplished without the use of any adhesives which could possibly react to the quantity 62 of potassium dichromate impregnated silica gel compound.
• an inert gas such as nitrogen or argon, free of oxygen and organic contaminants, is applied through the distal end of the mouthpiece portion 22 of the housing 12 to flow through the aperture 26, chemical bed sleeve
• this positive pressure of inert gas has the effect of purging any moisture, oxygen or other contaminants contained within the housing 12 and the quantity 62 of potassium dichromate impregnated silica gel that may have entered therein during assembly of the device 10.
• the end caps 16 and 18 may be placed on the distal ends of the housing 12 to in effect ' capture a quantity of the inert gas within the housing 12 and isolate the interior housing 12 from the external environment.
• a suitable packaging material such as a cellophane bag or envelope 120 may then be inserted over the entire assembly, a moderate vacuum may be drawn between the bag and the housing, and the bag may be subsequently sealed at opposite ends to form an hermetically sealed environment devoid of any oxygen, moisture, or organic compounds around the housing 12. Due to the assembled device 10 being completely devoid of any oxygen or moisture contaminants as well as having a positive pressure of inert gas existing within the interior of the housing 12, prolong storage or shelf life of the device 10 is insured.
• the operation of the disposable breath analyzer 10 of the present invention may be described. Due to its relatively small size (i.e. approximately one-half inch in diameter by four inches in length), the analyzer 10 may be easily carried by a user. When it is desired to obtain a blood alcohol concentration level of an individual, a user need only rupture the cellophane envelope sealed about the housing 12 and remove the end cap 16 and 18 from the housing 12. The mouthpiece portion 22 of the housing 12 may then be inserted into the mouth of the user and the user may exhale preferably two quantities of air through the mouthpiece each for ten second intervals.
• the valving members 70A and 7OB move from their full line position to their phantom position (as indicated in Figure 1) to allow the breath sample to enter into and pass through the quantity 62 of potassium dichromate impregnated silica gel as well as the quantity 60 of desiccant and 64 of nonindicating silica gel contained within the chemical bed sleeve 14.
• the breath sample passes through the quantity 62, the alcohol contained within the breath sample is absorbed or scrubbed causing the quantity of potassium dichromate impregnated silica gel to change from its initial color to a subsequent indicator color.
• the scrubbing properties of the silica gel 62 are such that the color change is linear and proportional to the amount of alcohol absorbed by the impregnated silica gel. As such, for a given volume of air sample (i.e. approximately one liter of air), a linear change in color of the quantity of gel .62 will be provided.
• the user may visually inspect the quantity of gel 62 by viewing through one of the window openings 32 formed in the main body portion 20 of the housing 12 and note the axial length of color change of the gel 62 upon the scaled indicia 122 formed on the main body portion 20 of the housing 12.
• the indicia is calibrated for blood alcohol level and, hence, an indication of the actual blood alcohol concentration of the individual can be obtained.
• the entire housing 12 may be discarded or alternatively maintained for future reference or evidentiary purposes.
• OMPI air through the housing 12 is eliminated.
• these valving members preferably form a sufficiently tight seal such that the quantity of silica, gel 62 is isolated from the exterior of the housing even if the device 10 is accidentally dropped into a user's drink.
• the housing 12 being formed of high impact strength polymeric material, any accidental breakage of the device 10 is substantially eliminated and access to the quantity of silica gel material 62 is eliminated except through purposeful unauthorized conduct by a user.

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• 1984
  • 1984-03-08 WO PCT/US1984/000345 patent/WO1985004016A1/en unknown
  • 1984-03-08 EP EP19840901296 patent/EP0173682A1/de not_active Withdrawn

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