Patent Publication Number: US-2023148903-A1

Title: Apparatus and methods for viral and bacterial breath collection

Description:
RELATED APPLICATIONS 
     This application claims the benefit of CoPending Provisional Application Serial No. 63/277,436 filed 9 Nov. 2021. 
    
    
     BACKGROUND OF THE INVENTION 
     Virus detection and analysis is a growing industry. Rapid testing methods are required to help detect viruses and bacteria. 
     Air from the lungs of a person can be used for many different types of testing that would otherwise require the person to undergo an invasive procedure. For example, alveolar air can be analyzed for the noninvasive diagnosis of a wide variety of conditions including the noninvasive diagnosis of stomach infections related to a high incidence of ulcers, enzymatic deficiencies, and metabolic conditions and/or abnormalities. Crucial to any such testing is the ability to get an accurate sample containing a sufficient volume of air representative of true alveolar air, desirable for specific testing. 
     There are several types of diagnostic tests for detection of viral and bacterial maladies. These include molecular assays such as rapid molecular assays and polymerase chain reaction (PCR) tests, and antigen detection tests. 
     There are three key steps to common PCR testing: 1) sample collection, 2) extraction, and 3) PCR analysis. 
     Sample collection is commonly done using a swab to collect respiratory material found for instance in a patient’s nose. A swab contains a soft tip on a long, flexible stick that is inserted into the patient’s nose. After collection, the swab is sealed in a tube and then sent to a laboratory. 
     When a laboratory technologist receives the sample, they perform sample extraction, which mixes liquids with the swab to extract the genetic material of any virus that may be on the swab. 
     The PCR step then tests the liquids from the sample extraction step. In this step, special chemicals and a PCR machine, called a thermal cycler, cause a reaction to occur that makes millions of copies of a small portion of a virus’s genetic material. During this process, one of the chemicals produces a fluorescent light if the targeted virus is present in the sample. This fluorescent light is a “signal” that is detected by the PCR machine and special software is used to interpret the signal as a positive test result. 
     SUMMARY OF THE INVENTION 
     This invention relates to the field of sampling air from the lungs and specifically to the field of obtaining a sample of a person’s breath, filtering the breath through a liquid medium and testing the liquid medium for viruses and bacteria, preferably but not limited to, PCR testing. 
     Breath is used to detect the presence of absence of a wide variety of viruses or bacteria, such as COVID, the flu, etc. A series of devices can be used to collect breath specimens. The breath specimen is then passed through a liquid or mixed with a liquid, or past a filter media. In the case of a breath specimen passed through a liquid, the liquid captures viruses or bacteria, and the liquid can then be tested, such as by a PCR machine. In the case of a breath specimen presented past a filter media, the filter media can be eluted with a liquid. The collected and processed liquid can then be tested by a laboratory, such as by using PCR techniques. 
     An apparatus for sampling exhaled breath of a test subject is disclosed, comprising a breath intake structure, a first one-way valve allowing passage of breath through said breath intake structure into an upstream portion of a chamber, a sealed vessel containing a volume of liquid and an evacuated portion, said sealed vessel selectively coupled with said chamber, a breath introduction passage between said upstream portion of said chamber into said volume of liquid in said sealed vessel, and a breath escape passage between said evacuated portion of said sealed vessel to allow said breath to escape said sealed vessel. Optionally, the apparatus further comprises a downstream portion of said chamber selectively coupled to said breath escape passage, and a dividing wall between said upstream and said downstream portions of said chamber. A second one-way valve allowing passage of breath from said downstream portion of said chamber out of said apparatus can be provided. 
     A method of sampling exhaled breath of a test subject is also disclosed, the method comprising breathing into said breath intake structure, directing the breath through said volume of liquid contained in said sealed vessel and into said evacuated portion of said sealed vessel, sampling said liquid for a presence or an absence of a predetermined malady such as viral or bacterial diseases. Breath is directed from said evacuated portion of said sealed vessel into said downstream portion of said chamber, and optionally, following the step of directing the breath through said volume of liquid contained in said sealed vessel and into said evacuated portion of said sealed vessel, decoupling said sealed vessel from said chamber, removing said liquid from said sealed vessel, sampling said liquid for said predetermined malady using at least one of a rapid molecular assay, a polymerase chain reaction test, and an antigen detection test. 
     A method of sampling exhaled breath of a test subject is also disclosed in which exhaled breath is exposed to a filter medium, passing liquid through said filter medium, collecting said liquid, sampling said liquid for a predetermined malady using at least one of a rapid molecular assay, a polymerase chain reaction test, and an antigen detection test. Optionally, said filter medium is carried by a structure coupled to a breath intake structure, which can comprise at least one of an expandable bag structure, a vial, and a chamber comprising a breath intake upstream of said filter medium and a breath exhaust downstream of said filter medium. 
     A method of sampling exhaled breath of a test subject, the method comprising collecting said exhaled breath in a vessel, introducing a liquid into said vessel, mixing said liquid and said exhaled breath, collecting said liquid, sampling said liquid for a predetermined malady using at least one of a rapid molecular assay, a polymerase chain reaction test, and an antigen detection test, which can be introduced into said vessel prior to or after collecting said exhaled breath in said vessel. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a side view of a device for sampling viruses and or bacteria from a breath sample by passing the breath sample through a liquid; 
         FIG.  2    is a cross-sectional view of the device of  FIG.  1   ; 
         FIG.  3    is a schematic depiction of a method for sampling viruses and or bacteria from a breath sample using the device of  FIG.  1   ; 
         FIG.  4    is a side view of a first alternate device for sampling viruses and or bacteria from a breath sample by passing the breath sample through a filter medium; 
         FIG.  5    is a cross-sectional view of the device of  FIG.  4   ; 
         FIG.  6    shows detachment of the filter medium from the breath testing device; 
         FIG.  7    is a schematic depiction of a method for sampling viruses and or bacteria from a breath sample using the device of  FIGS.  4 - 6   ; 
         FIG.  8    is a side view of a second alternate device for sampling viruses and or bacteria from a breath sample by trapping the breath sample against a filter medium; 
         FIG.  9    is a cross-sectional view of the device of  FIG.  8   ; 
         FIG.  10    is a side view of the device of  FIG.  8    sealed and prepared for transport; 
         FIG.  11    is a schematic depiction of a method for sampling viruses and or bacteria from a breath sample using the device of  FIGS.  8 - 10   ; 
         FIG.  12    is a side view of a third alternate device for sampling viruses and or bacteria from a breath sample by passing the breath sample through a filter medium; 
         FIG.  13 A  is a cross-sectional in use view of the device of  FIG.  12   ; 
         FIG.  13 B  is a cross-sectional view of the device of  FIG.  12   , with a liquid containing vessel detached from a breath expulsion vessel; 
         FIG.  13 C  is a side view of a test tube containing a mixture of breath and liquid; 
         FIG.  14    is a schematic depiction of a method for sampling viruses and or bacteria from a breath sample using the device of  FIGS.  12 - 13 C ; 
         FIG.  15   a    is a side view of a test tube method for sampling viruses and or bacteria from a breath sample; 
         FIG.  15   b    is the device of  FIG.  15   a    shown in use, receiving a breath sample; 
         FIG.  15   c    is the device of  FIG.  15   a    shown in use, carrying a captured a breath sample. 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention which may be embodied in other specific structures. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims. 
     Referring now collectively to  FIGS.  1 - 3   , a side view, a cross-sectional view and a schematic, respectively, of a device  10  for sampling viruses and or bacteria from a breath sample by passing the breath sample through a liquid  82  contained in a vial  80  is shown. A breath intake structure  12  receives breath from an individual. Breath first passes a first one-way flutter valve  18 . Breath next enters an upstream portion  14 ′ of chamber  14  (see  FIG.  2   ), the chamber  14  having a dividing wall  20  between the upstream portion  14 ′ and a downstream portion  14 ″ of said chamber. Next, the breath is routed into long needle  84 , the tip of which is submersed in liquid  82  contained in otherwise evacuated chamber, or vial  80  having a septum  88 . As the breath percolates though liquid  82 , the percolated breath escapes through short needle  86  in the headspace of vial  80  and past dividing wall  20 , and out a second one-way flutter valve  18 , and through discharge chute  16 . It is noted that two discrete needles  84  and  86  are shown with a small gap between them. The small gap can be of variable width, or, alternatively, the needles  84  and  86  can be coupled to one another. 
     Following the percolation of the breath through the liquid  82 , the device is removed from self-sealing membrane or septum  88 , leaving only liquid  82  and breath/headspace air contained within vial  80 . Vial  80  can then be transported for further processing, for example by a PCR machine in a laboratory. 
     Instead of using a vial  80  pre-supplied with liquid  82 , breath can be captured in vial  80 , and liquid  82  added later into vial  80 , and mixed with the collected breath contained in vial  80 . Alternatively, a user would take evacuated vial  80 , and elution liquid  82 , provided to the user separately, could be drawn into the vial  80 . The vial  80 , now containing elution mixture  80 , would be impaled through septum  88  onto needles  84  and  86 . 
     In the embodiment shown in  FIGS.  1  and  2   , it is preferred that needles  84  and  86  be initially be provided with a needle guard (not shown), similar to needle guard  214  as shown in  FIG.  12   , which would be removed immediately prior to impaling vial  80  onto needles  84  and  86 . 
     A breath testing apparatus such as shown in U.S. Pat. No. 10,413,216, incorporated herein by reference, can be also used to collect a breath specimen as described therein. 
     Referring now to  FIGS.  4 - 7   , a side view, a pair of cross-sectional views and a schematic, respectively, of a device  50  is shown. Device  50  is used for sampling viruses and/or bacteria from a breath sample by passing the breath sample through a filter medium  22 . Device  50  is a cylindrical tube shape chamber  52  coupled to breath intake structure  12 . At the outlet of breath intake structure  12  lies a one-way flutter valve  18 , which allows passage of breath into chamber  52 . At an outlet of chamber  52  lies filter medium (could be multiple types or styles of filter or medium)  22 . Filter medium  22  is inline with the flow of breath (could be within the tube, or on an end for removal after procedure). Breath passes one-way flutter valve  18 , and travels through chamber  52  past and across filter medium  22 . Referring to  FIG.  6   , filter medium  22  along with portion  24  of chamber  52  can be removed either by an individual and sent for further processing, or the entire device can be sent for further processing. Whether portion  24  is removed and sent for processing, or the entire device  50  is sent for processing, filter medium  22  would be eluted by a laboratory to process and analyze. 
     Referring now to  FIGS.  8 - 11   , a side view of a second alternate device  100  for sampling viruses and or bacteria from an exhaled breath sample is shown. In this embodiment, the breath sample is trapped against filter medium  118 . The air sampling device  100  is comprised of a breath intake structure  112  is used by a test subject to exhale breath into an expandable bag structure  110  through a bag structure inlet  116 . The breath intake structure  112  can be constructed of commonly available materials, and a drinking straw may be the preferred breath intake structure  112 . The expandable bag structure  110  is preferably constructed of a supple, airtight, gas impermeable, and inert material. 
     An adhesive patch  114  is adhered to an interior surface of the inlet  116 , and the adhesive patch  114  is selectively covered by a removable adhesive patch cover selectively adhered the first side of the adhesive patch  114 . The breath intake structure  112  is selectively communicatively coupled with expandable bag structure  110  through the inlet  116 , between a second interior surface of the inlet and the removable adhesive patch cover. 
     The adhesive patch  114  is coextensive with the inlet at one end, and another end extends into the interior of the expandable bag structure  110 . The removable adhesive patch cover is at one end coextensive with the adhesive patch first end, and the removable adhesive patch cover extends into the expandable bag structure  110  interior at least to the adhesive patch second end, and the other end of the removable adhesive patch cover extends out of the inlet. 
     An adhesive inlet seal patch  120  can be provided to supply additional seal to the expandable bag structure  110 , beyond the seal provided by the adhesive patch  114 . The adhesive inlet seal patch  120  can be labeled with a sample identifier, such as a barcode or machine-readable system. The sample identifier provides a convenient method for sequentially labeling air samples, should the samples include a preloaded dessicant or a chemical indicator, or should samples from different patients be shipped together. 
     A filter/medium  118  is placed within the bag  110 . The user inserts breath intake structure  112  into the bag  110  and blows breath through breath intake structure  112 . Any virus/bacteria present in the breath adheres or is trapped within the filter medium  118 . After exhalation, the user removes breath intake structure  112 , seals the bag  110  with adhesive patch  114  and, optionally, adhesive inlet seal patch  120 , and next wipes expandable bag structure  110  with a provided alcohol wipe and then ships expandable bag structure  110  to the laboratory. The laboratory can cut expandable bag structure  110  open and remove the filter medium and perform their preferred elution method and analyze on their preferred device. 
     Referring now to  FIGS.  12 - 14   , a third alternate device  210  for sampling viruses and/or bacteria from a breath sample is shown. In this embodiment, the breath sample is passed into an evacuated container or vial  80  as shown, the vial  80  having a self-sealable septum (not shown) initially impaled onto needle  216 .  FIG.  13 A  is a cross-sectional in use view of the device  210  of  FIG.  12   .  FIG.  13 B  is a cross-sectional view of the device  210  of  FIG.  12   , with breath containing vessel or vial  80  detached from the remaining components of device  210 , following collection of breath using device  210 .  FIG.  13 C  is a side view of vial  80  containing a mixture of breath and liquid  82 .  FIG.  14    is a schematic depiction of a method for sampling viruses and/or bacteria from a breath sample using device  210 . 
     Referring now to  FIGS.  12  and  13 A , a user breathes into mouthpiece  12 . Breath passes one-way flutter valve  18 , through chamber  14 , and a first portion of breath passes into waste bag  212 . As breathing into mouthpiece  12  continues, back pressure builds in waste bag  212 , until a second portion of breath (preferably alveolar air) passes into evacuated container or vial  80  through needle  216 , the needle  216  protected by needle guard  214 . 
     After the breath sample is collected in vial  80 , vial  80  can be separated from the remaining components of device  210 . A laboratory can then inject a preferred liquid solution for elution through the septum or self-sealing membrane on vial  80 , and next shake vial  80  to mix the headspace air/breath and liquid solution. Alternatively, vial  80  could initially be provided containing the elution liquid  82 , or the liquid  82  could be provided to the user in a test kit, the user then injecting liquid  82  into vial  80 . 
     The laboratory can then extract the liquid sample for further processing; e.g., PCR. 
     Referring now to either  FIGS.  13 A or  13 B , the container  80  could be pre-coupled 
     Referring now to  FIGS.  15 A-C , a side view of a test tube method for sampling viruses and/or bacteria from a breath sample is shown. In this embodiment, a user removes a cap  83  (shown in  FIG.  15 C ) from vial  80 , and inserts a breath intake structure  112  into vial  80 . The user then breathes a full breath through the breath intake structure  112  into the vial  80 , removes the breath intake structure  112  and quickly places the cap  83  back on the vial  80 . 
     Still referring to  FIGS.  15 A, B, and C , as is shown, the elution mixture  82  as described with reference to previous embodiments, is not required to be, but can be, initially within the vial  80 . 
     Also in this embodiment, a laboratory can then inject a preferred liquid solution for elution through a septum on vial  80  and shake the vial  80  to mix the headspace air/breath and liquid solution. Alternatively, a swab (not shown) could be introduced and contained within the vial  80 , and then following breath exhalation into the vial  80 , the swab could then be removed from the inside of the vial  80 , and then an elution mixture could be introduced to the swab. The laboratory can then extract the liquid sample for further processing; e.g., PCR. 
     The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.