US20200245899A1 - Mechanical Breath Collection Device - Google Patents

Mechanical Breath Collection Device Download PDF

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Publication number
US20200245899A1
US20200245899A1 US16/425,943 US201916425943A US2020245899A1 US 20200245899 A1 US20200245899 A1 US 20200245899A1 US 201916425943 A US201916425943 A US 201916425943A US 2020245899 A1 US2020245899 A1 US 2020245899A1
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United States
Prior art keywords
air
mouthpiece
impactor
breath collection
human subject
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Pending
Application number
US16/425,943
Inventor
Joseph A. Heanue
Jeffrey A. Stoll
Samartha G. Anekal
Kevin M. LIMTAO
Kevin Bradford Dunk
Jeffrey A. Schuster
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Hound Labs Inc
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Hound Labs Inc
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Priority to US16/425,943 priority Critical patent/US20200245899A1/en
Assigned to HOUND LABS, INC. reassignment HOUND LABS, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DUNK, Kevin Bradford, SCHUSTER, JEFFREY A., STOLL, Jeffrey A., HEANUE, JOSEPH A., ANEKAL, SAMARTHA G., LIMTAO, KEVIN M.
Priority to PCT/US2020/013553 priority patent/WO2020159698A1/en
Publication of US20200245899A1 publication Critical patent/US20200245899A1/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/08Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/082Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/08Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/097Devices for facilitating collection of breath or for directing breath into or through measuring devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4845Toxicology, e.g. by detection of alcohol, drug or toxic products
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/02Devices for withdrawing samples
    • G01N1/22Devices for withdrawing samples in the gaseous state
    • 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
    • G01N33/483Physical analysis of biological material
    • G01N33/497Physical analysis of biological material of gaseous biological material, e.g. breath
    • 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
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366Apparatus specially adapted for solid-phase testing
    • G01N33/54386Analytical elements
    • 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
    • G01N33/94Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
    • G01N33/948Sedatives, e.g. cannabinoids, barbiturates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other 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
    • A61B2010/0083Other 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 for taking gas samples
    • A61B2010/0087Breath samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04Constructional details of apparatus
    • A61B2560/0431Portable apparatus, e.g. comprising a handle or case
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04Constructional details of apparatus
    • A61B2560/0443Modular apparatus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04Constructional details of apparatus
    • A61B2560/0487Special user inputs or interfaces
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0247Pressure sensors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/02Devices for withdrawing samples
    • G01N1/22Devices for withdrawing samples in the gaseous state
    • G01N1/2202Devices for withdrawing samples in the gaseous state involving separation of sample components during sampling
    • G01N1/2208Devices for withdrawing samples in the gaseous state involving separation of sample components during sampling with impactors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/02Devices for withdrawing samples
    • G01N1/22Devices for withdrawing samples in the gaseous state
    • G01N1/2202Devices for withdrawing samples in the gaseous state involving separation of sample components during sampling
    • G01N2001/222Other features
    • G01N2001/2223Other features aerosol sampling devices
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/02Devices for withdrawing samples
    • G01N1/22Devices for withdrawing samples in the gaseous state
    • G01N2001/2244Exhaled gas, e.g. alcohol detecting

Definitions

  • the present disclosure relates to a portable and handheld mechanical breath collection device, for collection and capture of a chemical present in a human body.
  • the present disclosure is directed to a method for collecting breath containing a target chemical via a mechanical breath collection system, the method comprising: receiving air from a human subject via a mouthpiece configured to be placed in the human subject mouth; pumping the received air through a breath collection module configured to collect a desired volume of air from the human subject; trapping saliva from the received air in a saliva trap present in the breath collection module; and contacting the received air via inertial impaction on an impactor surface comprising a plurality of hollow impactor nozzles, such that aerosol droplets within the received air are captured by the impactor surface.
  • FIG. 1 illustrates an exemplary front view of a portable breath collection and analysis device.
  • FIG. 2 illustrates an exemplary back view of a portable breath collection and analysis device.
  • FIG. 3 illustrates an exemplary embodiment of a mechanical breath collection device.
  • FIG. 8 illustrates an exemplary flow chart for practicing methods of the present disclosure.
  • a hyphenated term (e.g., “on-demand”) may be occasionally interchangeably used with its non-hyphenated version (e.g., “on demand”)
  • a capitalized entry e.g., “Device”
  • its non-capitalized version e.g., “device”
  • a plural term may be indicated with or without an apostrophe (e.g., PE's or PEs)
  • an italicized term e.g., “N+1” may be interchangeably used with its non-italicized version (e.g., “N+1”).
  • Such occasional interchangeable uses shall not be considered inconsistent with each other.
  • Device 100 also contains a mouthpiece 115 , which may be a disposable tube that is placed into a subject's mouth while the subject breathes air into device 100 .
  • mouthpiece 115 may be constructed of PVC (polyvinyl chloride) or similar material. Mouthpiece 115 may be further connected to device 100 . In this way, mouthpiece 115 may be a removable and disposable component of device 100 .
  • breath collection module 400 comprises mouthpiece seal 410 , connector 415 , and impactor 420 .
  • mouthpiece seal 410 When air exits mouthpiece 115 , it travels through mouthpiece seal 410 and connector 115 to the impactor 420 of breath collection module 400 .
  • the saliva trap may be of a baffle-style design.
  • Mouthpiece seal 410 and connector 415 connect mouthpiece 115 with impactor 420 .
  • Connector 415 has a plurality of air vent holes 430 around an outer ring, that align with the impactor air vent holes 440 when assembled in device 100 .
  • Impactor 420 consists of impactor air vent holes 440 around an outer ring, and an inner ring area comprising the impactor surface 435 and impactor nozzle holes 425 .
  • impactor nozzles 425 are specifically designed to be of a size to capture drops with the most THC, based on weight.
  • device 100 may also comprise a pump 505 , as depicted in FIG. 5 .
  • the pump 505 can be activated via a pressure sensor 510 located within it.
  • Pump 505 provides the necessary vacuum to help a human subject exhale enough breath to overcome any impedance present in the line.
  • Device 100 is a durable component that has all of the hardware and software components to be able to control pump 505 , which provides the suction to facilitate breath capture.
  • Pressure sensor 510 is integrated within device 100 .
  • pressure sensor 510 When pressure sensor 510 detects that a human subject is blowing air through mouthpiece 115 , it activates (suction) pump 505 to increase the flow rate of air into it and facilitate breath capture. Typically a person can blow air at about 1 psi of pressure.
  • a subject breathes into device 100 at a regulated pressure to trigger the vacuum pump(s).
  • the pump 505 At a predefined pressure threshold, the pump 505 is triggered and turns on.
  • the predefined pressure threshold is 0.25 kPa, at which point the pump 505 turns on.
  • the positive pressure upstream of the impactor nozzles 425 is approximately 0.25 kPa.
  • the pressure drop across the impactor nozzles 425 is approximately 10 kPa at a flow rate of 8.5 liters per minute.
  • pump 505 does not turn on if a person is not actively breathing through mouthpiece 115 .
  • pressure sensor 510 detects a positive pressure at mouthpiece 115 and triggers the pump 505 to turn on. When the subject stops breathing, then pump 505 stops as well. Pump 505 may be connected via a TTL connection to other hardware components within device 100 .
  • pump 505 is a suction pump that does not output anything. It may also comprise one or more filters to protect its inner components from contamination. Anything collected at pump 505 does not have a path to travel upstream. Pump 505 may be periodically cleaned and/or replaced during maintenance of device 100 .
  • impactor surface 435 Some key parameters for the design of impactor surface 435 are the size, number, and placement, of impactor nozzles 425 .
  • the size of impactor nozzles 425 dictate the velocity of air flow and the number of nozzles needed. In an exemplary embodiment, there are 10 impactor nozzles 425 and a target airflow velocity is >100 m/s.
  • the form factor of the handheld device 100 there are certain usability requirements that are necessary to maximize breath collection for device 100 . Chief among those is the form factor of the handheld device 100 .
  • the handheld form factor further constrains the size of pump 505 . That is, pump 505 can deliver a certain flow rate when attached to a certain pressure drop of air. This yields a maximum dimension for pump size.
  • FIG. 6 depicts a graph 605 , with curve 620 depicting a relationship between a number of aerosol droplets collected (n) compared to a size (diameter) of aerosol droplets collected.
  • n a number of aerosol droplets collected
  • a size a size of aerosol droplets collected.
  • 18 liters of breath is desired to be captured within 2 minutes. For a typical human subject, this is approximately 3-10 breaths.
  • the flow rate of air is important. The higher the flow rate of air, the less time needed to collect the same volume. However, flow rate of air competes with velocity of air contacting impactor surface 435 . Higher velocity of air contacting impactor surface 435 is achieved at the cost of lowering the overall flow rate.
  • impactor 420 is manufactured from a material that is easy enough to remove THC from.
  • THC is a hydrophobic substance—that is, the THC refuses to stay in solution. Further, when presented with a surface, the THC tends to stay on the surface. Thus, a chemical is needed that releases the THC from the impactor surface 435 with sufficient speed and precision.
  • elution is used to extract the THC from the aerosol droplets.
  • elution is the process of extracting one material from another by washing with a solvent.
  • the captured aerosol droplets exiting impactor nozzles 425 are contacted with a fluid to solubilize the THC from the aerosol droplets into a solution.
  • a fluid to solubilize the THC from the aerosol droplets into a solution.
  • An elution buffer serves to remove the THC from the impactor surface 435 , and is also utilized as a solvent for a reagent in an immunoassay utilized by a cartridge within device 100 to analyze the concentration of THC present in the captured sample.
  • the elution buffer is compatible to an antibody in the immunoassay utilized downstream in device 100 , but also has properties that extract THC from impactor surface 435 .
  • CASPO and sodium deoxy cholate are discussed herein as one exemplary embodiment.
  • Other suitable chemicals may be used instead of, or in conjunction with, one or more of these chemicals in varying embodiments.
  • aerosol droplets containing THC are captured from an air flow by impactor surface 435 , and the remainder of the air is deflected outwards.
  • impactor surface 435 may be rotating to facilitate the outward air deflection. While air flow is being captured, no liquid flow is present.
  • the air ports may be blocked off via one or more valves, and elution fluid is passed through impactor surface 435 to extract the THC from the captured aerosol droplets.
  • the elution liquid with the extracted THC is then sent downstream to a cartridge 705 within device 100 , for analysis of THC concentration.
  • FIG. 8 depicts an exemplary flow chart for practicing embodiments of the present disclosure. It would be understood that there may be fewer or additional steps present than those depicted in FIG. 8 in various embodiments of the present disclosure.
  • step 810 the air is detected by a pressure sensor, and a pump is activated to increase the flow rate of the received air in step 815 .
  • the received air is them pumped through a breath collection module in step 820 .
  • Saliva from the received air is trapped in step 825 , and the remainder of the received air is contacted with an impactor surface to capture aerosol droplets containing the target chemical in step 830 .
  • the impactor surface is then washed with an elution buffer to extract and solubilize the target chemical from the captured aerosol droplets. While not depicted in FIG. 8 , the solubilized target chemical can then be transferred to another component for analysis, such as for determination of a concentration of the target chemical that is present in the solution.

Abstract

The present disclosure describes systems, methods, and apparatus for a portable and handheld mechanical breath collection device. The mechanical breath collection device collects air from a human subject, filters out saliva from the human subject, and collects aerosolized droplets from the received air via inertial impaction on an impactor surface. A target chemical is then extracted from the collected aerosolized droplets, and analyzed. In this way, a concentration of a target chemical present from the human subject can be determined by the portable and handheld device.

Description

    CROSS REFERENCE TO RELATED APPLICATIONS
  • The present application claims the priority benefit of U.S. Provisional Patent Application No. 62/799,675 filed on Jan. 31, 2019, which is incorporated by reference herein in its entirety.
  • FIELD OF THE INVENTION
  • The present disclosure relates to a portable and handheld mechanical breath collection device, for collection and capture of a chemical present in a human body.
  • BACKGROUND
  • Existing portable systems exist for measuring a concentration of ethanol present in a person's body, via their breath. However, such portable systems do not presently exist for measuring other substances accurately in a human body. The present disclosure is directed to a portable system, apparatus, and associated methods, for measuring such other substances in a human body via a mechanical breath collection device.
  • SUMMARY
  • This summary is provided to introduce a selection of concepts in a simplified form that are further described in the Detailed Description below. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.
  • In one embodiment, the present disclosure is directed to a mechanical breath collection system. The system comprises: a mouthpiece configured to be placed in a human subject mouth to receive air from the human subject; a breath collection module configured to collect a desired volume of air from the human subject, the breath collection module comprising: a saliva trap to separate saliva present in the air received from the human subject; and an impactor surface comprising a plurality of hollow impactor nozzles, the impactor surface capturing aerosol droplets from the received air from the human subject via inertial impaction; a pump configured to suction the received air from the mouthpiece through the breath collection module; and a pressure sensor in communication with the pump, the pressure sensor directing the pump to turn on when the received air is detected in the mouthpiece, and to turn off when no received air is detected in the mouthpiece.
  • In another embodiment, the present disclosure is directed to a method for collecting breath containing a target chemical via a mechanical breath collection system, the method comprising: receiving air from a human subject via a mouthpiece configured to be placed in the human subject mouth; pumping the received air through a breath collection module configured to collect a desired volume of air from the human subject; trapping saliva from the received air in a saliva trap present in the breath collection module; and contacting the received air via inertial impaction on an impactor surface comprising a plurality of hollow impactor nozzles, such that aerosol droplets within the received air are captured by the impactor surface.
  • Other features, examples, and embodiments are described below.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • The accompanying drawings, where like reference numerals refer to identical or functionally similar elements throughout the separate views, together with the detailed description below, are incorporated in and form part of the specification, and serve to further illustrate embodiments of concepts that include the claimed disclosure, and explain various principles and advantages of those embodiments.
  • The methods and systems disclosed herein have been represented where appropriate by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.
  • FIG. 1 illustrates an exemplary front view of a portable breath collection and analysis device.
  • FIG. 2 illustrates an exemplary back view of a portable breath collection and analysis device.
  • FIG. 3 illustrates an exemplary embodiment of a mechanical breath collection device.
  • FIG. 4 illustrates exemplary components of a mechanical breath collection module for a breath collection and analysis device.
  • FIG. 5 illustrates exemplary air flow from a mouthpiece via a pump system.
  • FIG. 6 illustrates exemplary graphs depicting a relationship between a number of aerosol droplets collected and the size of the collected aerosol droplets.
  • FIG. 7 illustrates a simplified top view of elution and air flow through an impactor surface and cartridge.
  • FIG. 8 illustrates an exemplary flow chart for practicing methods of the present disclosure.
  • DETAILED DESCRIPTION
  • In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the disclosure. It will be apparent, however, to one skilled in the art, that the disclosure may be practiced without these specific details. In other instances, structures and devices are shown as block diagram form only in order to avoid obscuring the disclosure.
  • Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” or “according to one embodiment” (or other phrases having similar import) at various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Furthermore, depending on the context of discussion herein, a singular term may include its plural forms and a plural term may include its singular form. Similarly, a hyphenated term (e.g., “on-demand”) may be occasionally interchangeably used with its non-hyphenated version (e.g., “on demand”), a capitalized entry (e.g., “Device”) may be interchangeably used with its non-capitalized version (e.g., “device”), a plural term may be indicated with or without an apostrophe (e.g., PE's or PEs), and an italicized term (e.g., “N+1”) may be interchangeably used with its non-italicized version (e.g., “N+1”). Such occasional interchangeable uses shall not be considered inconsistent with each other.
  • The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. It is further noted that various figures (including component diagrams) shown and discussed herein are for illustrative purpose only, and are not drawn to scale.
  • The present disclosure pertains to methods, systems, and apparatus for capturing particles in human breath, solubilizing and extracting certain chemical(s) from the captured breath, and measuring a concentration of the extracted chemicals. In one example, an amount of tetrahydrocannabinol (THC) level from a breath sample is determined by practicing embodiments of the present disclosure. While THC is discussed herein for simplicity, similar methods can be utilized to extract and measure a concentration of other chemicals in human breath as well, such as ethanol, other controlled substances, or airborne indicators of various disease states.
  • The present disclosure pertains to a portable handheld device and associated components for capturing and accurately measuring an amount of THC present in a person's breath. When THC is present in human breath, the bulk of it is contained within aerosol droplets. The present disclosure relates to mechanisms for capturing those aerosol droplets from human breath, such that a sufficient amount of THC can be captured from a human breath sample to accurately analyze. The THC is extracted from a physical surface of an impactor where it is collected and concentrated. The extracted THC is then mixed into a chemical solution for further analysis, such as to measure a concentration level.
  • FIG. 1 depicts an exemplary front view of a portable breath collection and analysis device 100 (also sometimes referred to herein as simply device 100). In various embodiments, breath collection and analysis device 100 is a handheld device that can be used in any physical location. All components for breath capture and analysis are contained on or within device 100.
  • In the exemplary figure, there is display 110 that may or may not be a touchscreen. From this display 110, an administrator utilizing device 100 to test a subject's breath can view information and results about the breath collection and sampling. As would be understood by persons of ordinary skill in the art, any information can be displayed on the display 110 for the administrator of device 100 and/or a subject whose breath is being tested.
  • Exemplary FIG. 1 also depicts a light array 105. Light array 105 may be one or more lights of any kind (such as LED lights), to quickly indicate a status of breath collecting, analysis, or other items. As would be understood by persons of ordinary skill in the art, light array 105 may be located at other places on device 100, and not solely in the location depicted in FIG. 1.
  • Device 100 also contains a mouthpiece 115, which may be a disposable tube that is placed into a subject's mouth while the subject breathes air into device 100. In various embodiments, mouthpiece 115 may be constructed of PVC (polyvinyl chloride) or similar material. Mouthpiece 115 may be further connected to device 100. In this way, mouthpiece 115 may be a removable and disposable component of device 100.
  • FIG. 2 depicts an exemplary back view of breath collection and analysis device 100. A power button 125 is depicted in the exemplary figure to turn device 100 on and off. In various embodiments, power button 125 may be located at other places on device 100, rather than solely in the location depicted in exemplary FIG. 2.
  • FIG. 3 depicts one exemplary embodiment of a mechanical breath collection device, for capturing aerosol droplets containing THC in a subject's breath. In the exemplary figure, an inertial impactor 300 is depicted. A human subject blows air into mouthpiece 115. The air flow from the human subject contains a plurality of aerosol droplets 310 within it. The aerosol droplets 310 may contain human saliva, THC, and/or other components.
  • As the air flow travels through mouthpiece 115, it is forced to make a sharp ninety degree turn. Because the aerosol droplets 310 are more dense than the surrounding air, they have more inertia and can't make the turn as quickly as the air. Consequently, the aerosol droplets continue to travel straight and are captured in the impactor surface 315. The air without the aerosol droplets turns and continues to travel outwards. In this way, the aerosol droplets containing THC are captured by impactor surface 315.
  • FIG. 4 depicts exemplary components of a mechanical breath collection module 400 for a breath collection and analysis device 100. As depicted in the figure, air flow (breath) from a human subject is first blown into mouthpiece 115. As discussed herein, the breath contains aerosolized droplets containing THC in it. This air then travels into breath collection module 400.
  • In exemplary embodiments, breath collection module 400 comprises mouthpiece seal 410, connector 415, and impactor 420. When air exits mouthpiece 115, it travels through mouthpiece seal 410 and connector 115 to the impactor 420 of breath collection module 400. In various embodiments, there may also be a saliva trap contained within mouthpiece 115 (not shown). The saliva trap may be of a baffle-style design.
  • Mouthpiece seal 410 and connector 415 connect mouthpiece 115 with impactor 420. Connector 415 has a plurality of air vent holes 430 around an outer ring, that align with the impactor air vent holes 440 when assembled in device 100. Impactor 420 consists of impactor air vent holes 440 around an outer ring, and an inner ring area comprising the impactor surface 435 and impactor nozzle holes 425.
  • After passing through connector 415, the air flow contacts impactor surface 435, with impactor nozzles 425. Impactor nozzles 425 may be of the same size, or of varying sizes. Upon contacting impactor surface 435, the aerosol droplets are captured via impactor nozzles 425, and the remainder of the air (without the aerosol droplets) is deflected outwards, as depicted in FIG. 3, or exits through impactor air vent holes 440. In exemplary embodiments, impactor nozzles 425 may be 0.4 mm diameter holes. In other embodiments, impactor nozzles 425 may be a 0.2 mm×1.0 mm rectangular slot, which yields approximately a 0.33 mm hydraulic diameter. In various embodiments, there may be 5-15 impactor nozzles present above impactor surface 435.
  • There are many considerations that affect the efficiency of capture of THC particles. Components of the present disclosure are designed to maximize the collection of aerosol droplets that have THC in them, after passing through impactor nozzles 425. That is, impactor nozzles 425 are specifically designed to be of a size to capture drops with the most THC, based on weight.
  • With smaller size impactor nozzles 425, the smallest of drops can be captured, but decreased hole sizes result in higher pressure drop as the air passes through them, which in turn limits the maximum attainable velocity of air and limits capture by breath collection module 400. On the other hand, increasing the flow rate of air passing through breath collection and analysis device 400 may cause smaller drops to pass through without being collected.
  • That is, higher velocities allow for capture of smaller drop sizes. In addition, a smaller diameter of impactor nozzle 425 also allows for higher velocities to be achieved. Higher velocities also cause a larger pressure drop, which leads to lower volumetric flow rates. Contrarily, a larger number of nozzles yields lower velocities. Thus, based on the pump selected, number of impactor nozzles 425, and nozzle size, the flow rate and velocities are fixed. One can tradeoff drop cutoff for flow rate by adjusting a number of impactor nozzles 425 present and a size of impactor nozzles 425. In one embodiment, a flow rate of 8-9 liters per minute is achieved. The flow rate is proportional to the radius of the impaction nozzles 425 squared. Thus, if the radius doubles, the flow rate is quadrupled.
  • To improve a flow rate through impactor nozzles 425, device 100 may also comprise a pump 505, as depicted in FIG. 5. The pump 505 can be activated via a pressure sensor 510 located within it. Pump 505 provides the necessary vacuum to help a human subject exhale enough breath to overcome any impedance present in the line.
  • Device 100 is a durable component that has all of the hardware and software components to be able to control pump 505, which provides the suction to facilitate breath capture. Pressure sensor 510 is integrated within device 100.
  • When pressure sensor 510 detects that a human subject is blowing air through mouthpiece 115, it activates (suction) pump 505 to increase the flow rate of air into it and facilitate breath capture. Typically a person can blow air at about 1 psi of pressure. In various embodiments, a subject breathes into device 100 at a regulated pressure to trigger the vacuum pump(s). At a predefined pressure threshold, the pump 505 is triggered and turns on. In one example, the predefined pressure threshold is 0.25 kPa, at which point the pump 505 turns on. Thus, the positive pressure upstream of the impactor nozzles 425 is approximately 0.25 kPa. The pressure drop across the impactor nozzles 425 is approximately 10 kPa at a flow rate of 8.5 liters per minute. In various embodiments, pump 505 does not turn on if a person is not actively breathing through mouthpiece 115.
  • When a subject starts to breathe through mouthpiece 115, pressure sensor 510 detects a positive pressure at mouthpiece 115 and triggers the pump 505 to turn on. When the subject stops breathing, then pump 505 stops as well. Pump 505 may be connected via a TTL connection to other hardware components within device 100.
  • Mechanical breath collection via inertial impaction requires the breath to impact impactor surface 435 at a fairly high velocity, such as 100 meters per second. When trying to push air at such a high velocity, it causes a high pressure drop. In this context, pressure drop is proportional to the square of velocity. The faster the velocity, the larger the pressure drop. However, at some point the pressure drop becomes so high, that a human breath alone cannot provide sufficient necessary pressure. Thus, by supplementing the human breath flow pressure with pump suction, it increases the pressure through mouthpiece 115, allowing for air to contact impactor surface 435 with sufficient velocity, despite the pressure drop from initial mouthpiece 115 contact through breath collection module 400.
  • In various embodiments, pump 505 is a suction pump that does not output anything. It may also comprise one or more filters to protect its inner components from contamination. Anything collected at pump 505 does not have a path to travel upstream. Pump 505 may be periodically cleaned and/or replaced during maintenance of device 100.
  • In an alternative embodiment, a mechanical impeller may be placed within mouthpiece 115. The mechanical impeller may spin when a subject blows air into mouthpiece 115 and accelerate air through mouthpiece 115. The mechanical impeller may be utilized instead of, or in conjunction with, pump 505.
  • Some key parameters for the design of impactor surface 435 are the size, number, and placement, of impactor nozzles 425. The size of impactor nozzles 425 dictate the velocity of air flow and the number of nozzles needed. In an exemplary embodiment, there are 10 impactor nozzles 425 and a target airflow velocity is >100 m/s.
  • As depicted in FIG. 5, there are certain usability requirements that are necessary to maximize breath collection for device 100. Chief among those is the form factor of the handheld device 100. The handheld form factor further constrains the size of pump 505. That is, pump 505 can deliver a certain flow rate when attached to a certain pressure drop of air. This yields a maximum dimension for pump size.
  • Given the predetermined size of pump 505 for device 100, with its predetermined relationship between flow rate and pressure drop, it is desirable to achieve the best velocity and maximum flow rate of air possible for optimal breath capture. For a given velocity of air flow, there is a relationship between a size of aerosol droplet collected, and the number of aerosol droplets collected.
  • FIG. 6 depicts a graph 605, with curve 620 depicting a relationship between a number of aerosol droplets collected (n) compared to a size (diameter) of aerosol droplets collected. For a given velocity, there is a sharp cutoff point 610. Above the cutoff point 610, almost all drops are collected, and below the cutoff point 610, almost no drops are collected.
  • Further, the larger the aerosol droplets collected, the more volume is collected. However, there are fewer of those drops of that size. An impactor designed to capture smaller drop sizes has a limitation that the total flow rate is lower. This results in a reduced volume of air which is run through the impactor for a given collection time, and decreases the number of drops captured. By adjusting the size of impactor nozzles 425, one can maximize the collection of aerosol droplets of a desired size range and number, to maximize the total volume of aerosol droplets collected by the impactor. In an exemplary embodiment, the flow rate is maximized such that droplets as small as 0.5 μm can be captured. In typical embodiments, droplets between 0.5-5.0 μm are captured.
  • Breath capture is also affected by a size of impactor nozzle 425, a number of impactor nozzles 425 present, and a geometry of how the nozzles are spaced relative to one another. The smaller the size of impactor nozzle 425, the bigger the pressure drop of air, but the faster the velocity of air as it passes through the nozzle. From an aerosol drop collection standpoint, the curve moves toward smaller drop sizes, as depicted by curve 625 of graph 615, but the overall air flow rates goes down, so the total volume of air collected in a given time goes down.
  • In an exemplary embodiment, 18 liters of breath is desired to be captured within 2 minutes. For a typical human subject, this is approximately 3-10 breaths. Because the total volume of air needed to be collected is fixed, the flow rate of air is important. The higher the flow rate of air, the less time needed to collect the same volume. However, flow rate of air competes with velocity of air contacting impactor surface 435. Higher velocity of air contacting impactor surface 435 is achieved at the cost of lowering the overall flow rate.
  • In various embodiments, device 100 tracks an amount of volume of air collected with each breath of the subject, until the full desired volume is collected. Further, with each breath, pump 505 is activated and then turns off when the breath stops, as detected by pressure sensor 510. That is, if a human subject blows into mouthpiece 115 four times, pump 505 turns on and off with each breath (four times total), within the allotted time (2 minutes in this exemplary embodiment).
  • Further, device 100 can track an amount of volume of air collected via a timer. Pump 505 dictates a flow rate of air passing through breath collection module 400. Thus, a flow rate of air passing through pump 505 is fixed, regardless of how fast or slow a subject blows through mouthpiece 115. Since the flow rate is dictated by pump 505, and is a known value, an amount of time needed to collect a fixed volume of air (such as 18 liters) can be determined. Device 100 may count down the time for each breath, until the requisite amount of time has elapsed and the desired volume of air is captured. This may help determine depth of sample volume from the subject's respiratory tract to minimize a potential for spoofing the system.
  • As would be understood by persons of ordinary skill in the art, although 18 liters is discussed herein as the desired volume of air to be captured, the present disclosure is equally applicable to other amounts of desired volume of air capture.
  • In various embodiments, impactor 420 is manufactured from a material that is easy enough to remove THC from. Generally, THC is a hydrophobic substance—that is, the THC refuses to stay in solution. Further, when presented with a surface, the THC tends to stay on the surface. Thus, a chemical is needed that releases the THC from the impactor surface 435 with sufficient speed and precision.
  • In exemplary embodiments, impactor surface 435 is constructed from one or more substances, such as acrylic (PMMA), polypropylene, polycarbonate, polystyrene, or other fluorinated polymer. Impactor nozzles 425 are molded into impactor surface 435.
  • Extraction of THC
  • After collection of aerosol droplets via impactor surface 435, elution is used to extract the THC from the aerosol droplets. In analytical and organic chemistry, elution is the process of extracting one material from another by washing with a solvent.
  • The captured aerosol droplets exiting impactor nozzles 425, are contacted with a fluid to solubilize the THC from the aerosol droplets into a solution. By minimizing the volume of solution used to extract the THC from the aerosol droplets, the concentration of THC in the solution can be maximized. Further, by utilizing a circular geometry in the breath collection module 400 pieces (such as impactor surface 435), one can minimize the total volume of fluid present in the breath collection module 400. This enables one to maximize the concentration of THC extracted.
  • An elution buffer serves to remove the THC from the impactor surface 435, and is also utilized as a solvent for a reagent in an immunoassay utilized by a cartridge within device 100 to analyze the concentration of THC present in the captured sample. Thus, the elution buffer is compatible to an antibody in the immunoassay utilized downstream in device 100, but also has properties that extract THC from impactor surface 435.
  • In an exemplary embodiment, CASPO (N-cyclohexyl-2-hydroxyl-3-aminopropanesulfonic acid) is a non-ionic buffer utilized as the elution buffer to extract THC from impactor surface 435. Generally, the higher the pH level of CASPO, the better. In exemplary embodiments, a pH level of 9 or greater is utilized. Further, sodium deoxy cholate (0.05-1%) is utilized as a surfactant to help solubilize the THC. The combination of CASPO and sodium deoxy cholate is utilized to extract the THC from impactor surface 435, while not interfering with the immunoassay chemistry utilized downstream in a cartridge in device 100 to analyze the captured sample.
  • As would be understood by persons of ordinary skill in the art, CASPO and sodium deoxy cholate are discussed herein as one exemplary embodiment. Other suitable chemicals may be used instead of, or in conjunction with, one or more of these chemicals in varying embodiments.
  • FIG. 7 depicts a top down view of elution and air flow. After air passes through impactor surface 435 and the desired volume of air is captured, the elution fluid passes through impactor surface 435 to capture the THC.
  • As depicted in FIG. 7, aerosol droplets containing THC are captured from an air flow by impactor surface 435, and the remainder of the air is deflected outwards. In exemplary embodiments, impactor surface 435 may be rotating to facilitate the outward air deflection. While air flow is being captured, no liquid flow is present. Once the desired volume of air has been captured (e.g., 18 liters), then the air ports may be blocked off via one or more valves, and elution fluid is passed through impactor surface 435 to extract the THC from the captured aerosol droplets. The elution liquid with the extracted THC is then sent downstream to a cartridge 705 within device 100, for analysis of THC concentration.
  • FIG. 8 depicts an exemplary flow chart for practicing embodiments of the present disclosure. It would be understood that there may be fewer or additional steps present than those depicted in FIG. 8 in various embodiments of the present disclosure.
  • In the exemplary method for collecting breath containing a target chemical via a mechanical breath collection method, the method begins with receiving air from a human subject in step 805. The air can be received via a mouthpiece, such as mouthpiece 115 discussed herein.
  • In step 810, the air is detected by a pressure sensor, and a pump is activated to increase the flow rate of the received air in step 815. The received air is them pumped through a breath collection module in step 820. Saliva from the received air is trapped in step 825, and the remainder of the received air is contacted with an impactor surface to capture aerosol droplets containing the target chemical in step 830. The impactor surface is then washed with an elution buffer to extract and solubilize the target chemical from the captured aerosol droplets. While not depicted in FIG. 8, the solubilized target chemical can then be transferred to another component for analysis, such as for determination of a concentration of the target chemical that is present in the solution.
  • The corresponding structures, materials, acts, and equivalents of all means or step plus function elements in the claims below are intended to include any structure, material, or act for performing the function in combination with other claimed elements as specifically claimed. The description of the present disclosure has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the present technology in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the present disclosure. Exemplary embodiments were chosen and described in order to best explain the principles of the present disclosure and its practical application, and to enable others of ordinary skill in the art to understand the present disclosure for various embodiments with various modifications as are suited to the particular use contemplated.
  • Aspects of the present disclosure are described above with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems) according to embodiments of the present disclosure.
  • The flowchart and block diagrams in the Figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods and apparatus, according to various embodiments of the present disclosure.
  • Thus, systems and methods for collecting and extracting a target chemical from human breath are described herein. While various embodiments have been described, it should be understood that they have been presented by way of example only, and not limitation. The descriptions are not intended to limit the scope of the disclosure to the particular forms set forth herein. Thus, the breadth and scope of a preferred embodiment should not be limited by any of the above-described exemplary embodiments. It should be understood that the above description is illustrative and not restrictive. To the contrary, the present descriptions are intended to cover such alternatives, modifications, and equivalents as may be included within the spirit and scope of the disclosure as defined by the appended claims and otherwise appreciated by one of ordinary skill in the art. The scope of the present disclosure should, therefore, be determined not with reference to the above description, but instead should be determined with reference to the appended claims along with their full scope of equivalents.

Claims (20)

What is claimed is:
1. A mechanical breath collection system comprising:
a mouthpiece configured to be placed in a human subject mouth to receive air from the human subject;
a breath collection module configured to collect a desired volume of air from the human subject, the breath collection module comprising:
an impactor surface comprising a plurality of hollow impactor nozzles, the impactor surface capturing aerosol droplets from the received air from the human subject via inertial impaction;
a pump configured to suction the received air from the mouthpiece through the breath collection module; and
a pressure sensor in communication with the pump, the pressure sensor directing the pump to turn on when the received air is detected in the mouthpiece, and to turn off when no received air is detected in the mouthpiece.
2. The system of claim 1, wherein the pump is a suction pump.
3. The system of claim 1, wherein the impactor surface is manufactured from polystyrene.
4. The system of claim 1, wherein the captured aerosol droplets from the received air comprise THC.
5. The system of claim 1, further comprising at least one valve between the mouthpiece and the breath collection module, the at least one valve configured to allow air flow from the mouthpiece into the breath collection module when in an open position, and block air flow from the mouthpiece into the breath collection module when in a closed position.
6. The system of claim 1, further comprising an elution buffer solution configured to extract and solubilize a target chemical from the aerosol droplets captured in the impactor surface.
7. The system of claim 6, wherein the elution buffer solution comprises CASPO.
8. The system of claim 6, wherein the elution buffer solution comprises sodium deoxy cholate.
9. The system of claim 6, wherein the elution buffer solution is at a pH level of 9 or greater.
10. The system of claim 6, wherein the solubilized chemical from the aerosol droplets is solubilized THC.
11. The system of claim 1, wherein the mouthpiece further comprises a saliva trap.
12. The system of claim 1, wherein the mouthpiece is removable from the mechanical breath collection system.
13. The system of claim 1, wherein the mouthpiece is disposable.
14. The system of claim 1, wherein the desired volume of air collected from the human subject is 18 liters.
15. A method for collecting breath containing a target chemical via a mechanical breath collection system, the method comprising:
receiving air from a human subject via a mouthpiece configured to be placed in the human subject mouth;
pumping the received air through a breath collection module configured to collect a desired volume of air from the human subject;
trapping saliva from the received air in a saliva trap present in the breath collection module; and
contacting the received air via inertial impaction on an impactor surface comprising a plurality of hollow impactor nozzles, such that aerosol droplets within the received air are captured by the impactor surface.
16. The method of claim 15, wherein the desired volume of air collected from the human subject is 18 liters.
17. The method of claim 15, further comprising:
washing the impactor surface with an elution buffer solution configured to extract and solubilize a target chemical from the captured aerosol droplets.
18. The method of claim 17, wherein the target chemical is THC.
19. The method of claim 17, wherein the elution buffer solution comprises CASPO.
20. The method of claim 17, wherein the elution buffer solution comprises sodium deoxy cholate.
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