JP2023516023A - Breath sampling device and method using controllable volume container - Google Patents

Abstract

Breath sample collection devices and methods are provided. The device has a breath input interface configured to receive exhaled breath and a container connected to the breath input interface for receiving at least a portion of the exhaled breath, the container being controllable. A cavity of volume and at least one controller configured to control the volume of the cavity to increase at a rate of volume increase at most equal to the flow rate of exhaled breath received by the breath input interface.

Description

TECHNICAL FIELD This specification relates generally to sampling systems, and more particularly to devices and methods for collecting breath samples.

Breath sampling has traditionally been performed by collecting exhaled breath from a patient into a large container. A breath sample is then extracted from the container and transferred directly to the analyzer.

More recently, breath samples have been collected in breath sample reservoirs known as sorbent or thermal desorption tubes. A sorbent tube is a tube containing a solid sorbent material with a large surface area. When a gas sample is passed through the sorbent tube, some components such as oxygen and carbon dioxide flow out the opposite end of the sorbent tube while other components are adsorbed onto the sorbent. This allows many of the components in the exhaled breath sample to be trapped on the sorbent while allowing the components with the highest volume to flow out, thereby concentrating the exhaled breath sample. As a result, most of the components of the exhaled breath sample can be collected within a smaller volume.

However, there are many problems with devices that allow direct human filling of these sorbent tubes. There is a significant amount of humidity in human breath that can interfere with breath collection in this mode. This humidity can cause condensation inside the conduit that directs exhaled air to the sorbent tube. This condensation draws in many of the components of exhaled air that are free to attach to water molecules. As a result, many of the breath sample components do not reach the sorbent tube and thus do not appear in at least a portion of the breath sample analyzed.

Another problem is that the sorbent tube traps components of exhaled breath more effectively at certain flow rates of exhaled breath through the sorbent tube. The rate at which exhaled air flows through the sorbent tube in prior art devices is driven by the rate at which exhaled air is blown into these devices by a person. This leads to a loss of some exhaled breath sample.

In one aspect, a breath input interface configured to receive exhaled breath; a reservoir connected to said breath input interface for storing at least a portion of said breath; and when receiving said breath. and at least one controller configured to control the flow of at least a portion of said exhaled breath asynchronously from said container to at least one sorbent tube connected to said container. is provided.

The container can have a cavity in which at least a portion of the exhaled breath is stored, the volume of the cavity being controllable. The volume of the cavity may be controllable by the at least one controller. The container may include a piston chamber having a piston disposed therein, the position of the piston controlling the volume of the cavity. The at least one controller may be configured to actuate the piston to increase the volume of the cavity as the at least a portion of the exhaled breath is received.

The device further includes a valve intermediate the exhalation input interface and the container;
A first conduit connecting the exhalation input interface and the valve, and a second conduit connecting the container to the at least one sorbent tube may be included. The at least one controller is configured to control closing of the valve and control operation of the piston to force the at least a portion of the exhaled breath through a subset of the at least one sorbent tube. can be A tube inlet valve may be positioned between the vessel and each of the at least one sorbent tube. The at least one controller is configured to control each of the at least one tube inlet valve to select the subset of the at least one sorbent tube through which the at least a portion of the exhaled breath flows. obtain.

The subset may be a first subset, the apparatus may further include an inlet valve disposed along the second conduit system between an inlet and the vessel, and the at least one controller may be configured to open the inlet valve and control actuation of the piston to draw air into the cavity through the inlet, and the at least one controller closes the inlet valve to remove the entrained air. It may be configured to propel from the cavity through the second conduit system. The at least one controller can control actuation of the piston to propel the entrained air through a second subset of the at least one sorbent tube. A tube inlet valve may be positioned between the vessel and each of the at least one sorbent tube. The at least one controller is configured to control each of the at least one tube inlet valves to select the second subset of the at least one sorbent tubes through which the entrained air flows. obtain.

The container may include an at least partially flexible collapsible receptacle. The apparatus further comprises a valve intermediate the exhalation input interface and the container, a first conduit system connecting the exhalation input interface and the valve, and a second system connecting the container to the at least one sorbent tube. 2 conduit systems. The apparatus further includes a pump controlled by the at least one controller and capable of propelling the at least a portion of the exhaled breath from the reservoir through the subset of the at least one sorbent tube. A tube inlet valve may be positioned between the vessel and each of the at least one sorbent tube. The at least one controller is configured to control each of the at least one tube inlet valve to select the subset of the at least one sorbent tube through which the at least a portion of the exhaled breath flows. obtain.

The pump may be disposed between the valve and the container, and the at least one controller may be configured to control the pump to draw the at least a portion of the exhaled breath into the container. .

The subset may be a first subset, the apparatus may further include an inlet valve disposed along the second conduit system between an inlet and the vessel, the at least one controller comprising: , closing the inlet valve and controlling the pump to flow air from the vessel through a second subset of the at least one sorbent tube. The at least one controller may be configured to open the inlet valve and control the pump to flow air through the inlet and into the cavity. A tube inlet valve may be positioned between the vessel and each of the at least one sorbent tube. The at least one controller controls each of the at least one tube inlet valves to select the first subset of the at least one sorbent tube through which the at least a portion of the exhaled breath flows. can be configured to

The device may further comprise a valve intermediate the exhalation input interface and the container, and a first conduit connecting the exhalation input interface and the valve. The at least one controller controls the volume of the container by controlling the valve to close to control the volume of the at least one sorbent tube when a target volume of exhaled breath is captured in the container. It may be configured to propel said at least a portion of said exhaled breath through a subset. The at least one controller controls one of at least two exhalation flow rates at which the at least one controller can control the volume of the reservoir to propel the exhalation through the subset of the at least one sorbent tube. and can be configured to control the volume of the container to decrease.

In another aspect, a method of collecting a breath sample is provided, comprising the steps of: receiving exhaled breath via a breath input interface; at least one of the steps of at least one and controlling via a controller.

The storing step may include storing the at least a portion of the exhaled breath in a cavity of the container, the volume of the cavity being controllable. The method may further include controlling the volume of the cavity via the at least one controller. The method may further include activating, via the at least one controller, a piston disposed within a piston chamber of the container, the position of the piston controlling the volume of the cavity. The method may further include actuating the piston to increase the volume of the cavity while receiving the at least a portion of the exhaled breath. The method may further include controlling the flow of the at least a portion of the exhaled breath through a valve intermediate the breath input interface and the container, wherein a first conduit line communicates with the breath input interface. A second conduit system connects the valve and connects the vessel to the at least one sorbent tube. The method further includes controlling, via the at least one controller, the valve to close; It may include driving the part. A tube inlet valve may be disposed between the container and each of the at least one sorbent tube, and the method further controls each of the at least one tube inlet valve to cause the at least selecting said subset of said at least one sorbent tube to be partially flushed.

The method further controls, via the at least one controller, controlling to close the valve; controlling to open an inlet valve that isolates the container from an inlet; and controlling actuation of the piston. drawing air into the cavity through the inlet, controlling the inlet valve to close, and controlling actuation of the piston to propel the entrained air out of the cavity through the second conduit system. can include steps.

The method may further include controlling actuation of the piston to propel the entrained air through a second subset of the at least one sorbent tube. A tube inlet valve may be positioned between the vessel and each of the at least one sorbent tube. The method may further include controlling each of the at least one tube inlet valve to select the second subset of the at least one sorbent tube through which the entrained air is flowed.

The container may include an at least partially flexible collapsible receptacle. The method may further include controlling flow of the at least a portion of the exhaled breath through a valve intermediate the exhaled breath input interface and the container, wherein a first conduit connects the exhaled breath input interface and the valve. and a second conduit system connects the vessel to the at least one sorbent tube. The method may further include controlling a pump to flow at least a portion of the expired air from the reservoir through a subset of the at least one sorbent tube. A tube inlet valve may be positioned between the vessel and each of the at least one sorbent tube. The method may further include controlling each of the at least one tube inlet valve to select the subset of the at least one sorbent tube through which the at least a portion of the exhaled gas is flowed.

The pump may be positioned between the valve and the container, and the method may further include controlling the pump to draw the at least a portion of the exhaled breath into the container.

The subset may be a first subset, the method further comprising: closing the valve; opening an inlet valve intermediate the inlet and the vessel; controlling the pump to cause the at least one flowing air through a second subset of sorbent tubes of . The method may further include opening an inlet valve and controlling the pump to flow air through the inlet and into the cavity. A tube inlet valve may be positioned between the vessel and each of the at least one sorbent tube. The method may further include controlling each of the at least one tube inlet valve to select the subset of the at least one sorbent tube through which the at least a portion of the exhaled breath is flowed.

The method may further include controlling flow of the exhaled breath through a valve to the container from a first line of conduit to which the breath input interface is connected. The method further comprises controlling the valve to close; and, upon capturing a target volume of the exhaled breath within the container, the at least a portion of the exhaled breath through the subset of the at least one sorbent tube. controlling the volume of the vessel to flow the during the step of controlling the volume, the volume may be controlled such that the volume decreases to propel the exhaled breath through the subset of the at least one sorbent tube of at least two exhalation flow rates; can be controlled to decrease with one of

In a further aspect, there is provided a breath sample collection device, the device configured to have a breath input interface configured to receive exhaled breath and to measure a component level in the received breath. a metering device extending from said breath input interface and connected to at least one breath sample reservoir; determining whether the component level is within a component level target range and determining whether the component level rate of change is within the component level rate of change target range; and control to open the valve based at least in part on whether the component level is within the component level target range and whether the rate of change is within the component level rate of change target range. and at least one controller configured to.

said metering device may be a capnometer, said component level may be a carbon dioxide level,
The component level target range may be a carbon dioxide level target range and the component level rate of change target range may be a carbon dioxide level rate of change target range. The device may further include a flow meter configured to measure a flow rate of the exhaled breath being received, wherein the at least one controller determines that the measured flow rate is within a flow target range. is configured to control the valve to open based, at least in part, on . The device may further include a display, and the at least one controller is configured to control the display to cause the display to present a flow rate notification.

The apparatus may further include at least one optical element, and the at least one controller is configured to control the at least one optical element to cause the at least one optical element to present a flow rate notification. .

The device may further include a speaker, and the at least one controller is configured to control the speaker to play an audible flow notification through the speaker.

The component level target range may span between a component level minimum threshold and an upper limit of infinity.

The component level rate of change target range may span between a lower limit of infinity and a maximum component level rate of change threshold.

The flow target range may span between a minimum flow threshold and an infinite upper limit.

The at least one controller may be configured to monitor the component level after opening the valve.

the device may further include a flow meter configured to measure a flow rate of the exhaled breath being received, the at least one controller monitoring the flow rate after opening the valve; configured to control the valve to close based at least in part on the measured flow being within a flow end range.

In yet another aspect, a method of collecting exhaled breath samples is provided, wherein exhaled exhaled breath is passed through a breath input interface having a first line of conduit extending toward at least one exhaled breath sample storage device therefrom. receiving, wherein a valve is arranged to control movement of said exhaled breath from said first conduit system to said at least one breath sample reservoir; determining whether the constituent level in the exhaled breath being measured is within an constituent level target range; and determining that the rate of change of the constituent level is within the constituent level rate of change target range. and controlling the opening of the valve based at least in part on whether the component level is within the component level target range and whether the rate of change is within the component level rate of change target range. including.

The ingredient level may be a carbon dioxide level, the ingredient level target range may be a carbon dioxide level target range, and the ingredient level rate of change target range may be a carbon dioxide level rate of change target range.

The method may further include measuring a flow rate of the exhaled breath being received, wherein capturing is performed based at least in part on the measured flow rate being within a flow target range. be done. The method may further include controlling a display to cause the display to present a flow rate notification. The method may further include controlling at least one optical element to cause the at least one optical element to present a flow rate notification.

The method may further include controlling a speaker to play an audible flow notification through the speaker.

The carbon dioxide level target range may span between a carbon dioxide level minimum threshold and an infinite upper limit.

The carbon dioxide level rate of change target range may span between a lower infinite limit and a maximum carbon dioxide level rate of change threshold.

The flow target range may span between a minimum flow threshold and an infinite upper limit.

The method may further include monitoring the carbon dioxide level after opening the valve.

The method may further include measuring a flow rate of the exhaled breath being received, wherein the at least one controller monitors the flow rate after opening the valve, and wherein the measured flow rate is configured to control the valve to close based at least in part on being within a flow end range.

In yet another aspect, a breath sampling device is provided, the device comprising a breath input interface configured to receive exhaled breath, a first line of tubing connected to the breath input interface; a valve configured to control fluid communication between the first conduit system and at least one breath sample reservoir configured to store a breath sample; an air circulation system configured to circulate air through said first conduit system upon completion; at least one controller configured to control the valve.

The at least one controller may be configured to control the valve based at least in part on whether the rate of change of the humidity level is within a humidity level rate of change target range. The at least one controller closes the valve to remove the at least one gas from the first conduit system until the rate of change of the humidity level in the first conduit system is within the humidity level rate of change target range. It may be configured to inhibit passage of subsequent exhaled breath to one breath sample reservoir. The apparatus may further include a hygrometer connected to the first conduit system and configured to measure the humidity level within the first conduit system. The apparatus may further include a notification system for indicating when the rate of change of the humidity level within the first conduit system is within the target humidity level rate of change range.

The first conduit system may include an exhalation intake conduit extending between the exhalation input interface and the valve, the hygrometer being an exhaust conduit of the first conduit branching from the exhalation intake conduit. can be connected to The fluid circulation system may be directly connected to the exhaust conduit. The exhaust conduit may include a flow meter configured to measure flow along the exhaust conduit.

The at least one controller may be configured to control the valve based at least in part on whether the humidity level is within a humidity level target range. The at least one controller closes the valve from the first conduit to the at least one breath sample reservoir until the humidity level in the first conduit is within the humidity level target range. can be configured to inhibit the passage of subsequent exhaled air from the

In another aspect, a method of collecting breath samples is provided, comprising the steps of: receiving exhaled breath via a breath input interface connected to a first line of conduit; collecting at least a portion of said exhaled breath via at least one connected breath sample reservoir; detecting completion of said exhaled breath; closing a valve between the first conduit and the at least one sorbent tube upon detection; circulating air through a system of conduits; monitoring a humidity level within said first system of conduits; and controlling the valve based on.

The controlling step may include determining whether the rate of change of the humidity level is within a humidity level rate of change target range. The method further includes closing the valve and exhaling the at least one exhaled breath from the first conduit system until the rate of change of the humidity level within the first conduit system is within the target humidity level rate of change range. controlling to inhibit passage of subsequent exhaled breath to the sample reservoir. The method may further include measuring the humidity level within the first conduit system via a hygrometer connected to the first conduit system. The method may further include indicating when the rate of change of the humidity level is within the humidity level rate of change target range.

The first conduit system may include an exhalation intake conduit extending between the exhalation input interface and the valve, and wherein the step of measuring the humidity level comprises the first conduit branching from the exhalation intake conduit. It is performed by a hygrometer connected to the system exhaust conduit. The fluid circulation system may be directly connected to the exhaust conduit. The method may further include measuring flow along the exhaust conduit via a flow meter along the exhaust conduit.

The controlling step may include determining whether the humidity level is within a humidity level target range. The method further includes closing the valve to direct a flow from the first conduit to the at least one exhaled breath sample reservoir until the humidity level in the first conduit is within the humidity level target range. Controlling to inhibit passage of subsequent exhaled breath may be included.

In a further aspect, a breath sample collection device is provided, the device comprising a breath input interface configured to receive exhaled breath, a first conduit system connected to the breath input interface, and the breath sample. at least one breath sample reservoir connected to the breath input interface via a breath intake conduit of the first conduit system extending between the input interface and the breath collection system; The breath sample reservoir is configured to capture said at least a portion of said exhaled breath and further comprises at least one metering device for measuring at least one characteristic, said at least one metering device for measuring said exhaled breath. Disposed along the exhaust conduit of the first conduit branching from the intake conduit.

The at least one metering device may include a flow meter that measures flow of the exhaled breath along the exhaust conduit of the first conduit system. The at least one metering device may include a capnometer positioned along the exhaust conduit of the first conduit system to measure carbon dioxide levels in the exhaled breath.

The at least one metering device may include a hygrometer positioned along the exhaust conduit of the first conduit system for measuring humidity levels within the discharge conduit. The apparatus may further include a pump disposed along the exhaust conduit of the first system of conduits to force air through the exhaust conduit.

In yet another aspect, a method of collecting a breath sample is provided, the method comprising receiving exhaled breath via a breath input interface; a first line of conduit connected to the breath input interface; capturing exhaled breath through said breath collection system connected to said breath input interface via a breath intake conduit of a first conduit system extending between said breath input interface and said breath collection system; and measuring at least one characteristic along an exhaust conduit of said first conduit system branching from said exhalation intake conduit via at least one metering device disposed along said exhaust conduit.

The at least one metering device may include a flow meter, and the at least one characteristic may include flow rate of the exhaled breath along the exhaust conduit.

The at least one metering device may comprise a capnometer and the at least one characteristic may comprise the exhaled breath carbon dioxide level.

The method may further include measuring a humidity level along the exhaust conduit via a hygrometer positioned along the exhaust conduit of the first conduit system. The method may further include flowing air through the exhaust conduit via a pump positioned along the exhaust conduit.

In yet another aspect, a breath sampling device is provided, the device comprising a breath input interface configured to receive exhaled breath, and a breath input interface configured to receive exhaled breath, the breath to receive at least a portion of the exhaled breath. a container connected to an input interface and having a cavity of controllable volume; and at least one controller configured to control.

A first conduit system of breath intake conduits may extend from the breath input interface towards the container, and the first conduit system of exhaust conduits diverges from the breath collection portion at a first end thereof. and has an outlet at its second end. The apparatus may further include a flow meter positioned to measure flow along the exhaust conduit. A volumetric rate of increase of the volume of the vessel may be proportional to the flow rate along the exhaust conduit. The volume of the container may be directly mechanically controllable by the at least one controller. The container may include a piston chamber having an actuatable piston disposed therein, the position of the piston within the piston chamber defining the volume of the cavity. The device may further include a valve arranged to control movement of the exhaled breath into the piston chamber. The apparatus may further include at least one sorbent tube connected to the vessel, the at least one controller controlling the valve to close and controlling the actuation of the piston to actuate the at least one sorbent tube. configured to propel the exhaled air within the cavity through a sorbent tube.

The container may include an at least partially flexible collapsible receptacle, and the device is further configured intermediate the exhalation input interface and the container to include the at least partially flexible collapsible receptacle. A pump may be included therein capable of propelling said exhaled breath at said rate of volume increase. The device may further include at least one sorbent tube connected to the at least partially flexible collapsible receptacle, wherein the at least one controller controls a subset of the at least one sorbent tube. and configured to control the pump to propel the exhaled air within the cavity through a. The device may further include a valve arranged to control movement of the exhaled breath into the piston chamber.

The device may further include a valve arranged to control movement of the exhaled breath into the piston chamber. The apparatus may further include a metering device arranged to measure a component level within the exhaust conduit, the at least one controller determining whether the component level is within a target component level range; determining whether the rate of change of the component level is within the component level rate of change target range, whether the component level is within the component level target range and if the rate of change is within the component level rate of change target range; may be configured to control the valve to open based at least in part on whether there is a The metering device may be a capnometer, the component level may be a carbon dioxide level, the component level target range may be a carbon dioxide level target range, and the component level rate of change target range may be a carbon dioxide level rate of change target range. can be

The device further comprises an exhaled intake conduit of a first conduit system extending from the exhaled breath input interface toward the container; can include totals. The volumetric rate of increase of the volume of the container may be proportional to the flow rate along the respiratory intake conduit. The volume of the container may be directly mechanically controllable by the at least one controller. The container may include a piston chamber having an actuatable piston disposed therein, the position of the piston within the piston chamber defining the volume of the cavity. The device may further include a valve arranged to control movement of the exhaled breath into the piston chamber. The apparatus may further include at least one sorbent tube connected to the vessel, the at least one controller controlling the valve to close and controlling the actuation of the piston to actuate the at least one sorbent tube. is configured to propel the exhaled air within the cavity through a subset of sorbent tubes of the.

The container may include an at least partially flexible collapsible receptacle, the device further configured intermediate the exhalation input interface and the container for exhaling the exhaled breath at the volume increase rate to the at least partially collapsible receptacle. A pump may be included to propel into the flexible collapsible receptacle.

In yet another aspect, a method of collecting a sample of exhaled breath is provided, comprising the steps of: receiving exhaled breath via an exhaled breath input interface; at least partially replenishing said container having a controllable volume cavity; but controlling to increase the volume of the vessel at an equal rate of volume increase.

A first conduit system breath intake conduit can extend from the breath input interface towards the container and a first conduit system exhaust conduit diverges from the breath collection portion at a first end thereof. may have an outlet at its second end. The method may further include measuring flow along the exhaust conduit via a flow meter. The volumetric rate of increase of the volume of the container may be proportional to the flow rate. The method may further include directly mechanically controlling the volume of the container. The container may include a piston chamber in which a piston is disposed, the position of the piston defining the volume of the cavity, and the step of directly mechanically controlling includes actuating the piston. The method may further include transferring the exhaled breath into the piston chamber via a valve positioned between the breath input interface and the container. The method may include controlling the valve to close and controlling actuation of the piston to propel exhaled air within the cavity through at least one sorbent tube connected to the container. .

The container may include an at least partially flexible collapsible receptacle, and the method further comprises: at the volume increase rate, the at least partially flexible receptacle via a pump intermediate the exhalation input interface and the container. propelling the exhaled breath into a flexible collapsible receptacle.

The method further includes controlling the pump to propel the exhaled air within the cavity through a subset of the at least one sorbent tube connected to the at least partially flexible collapsible receptacle. can include The method may include controlling movement of the exhaled breath through a valve to the piston chamber.

The method may further include controlling movement of the exhaled breath through a valve to the piston chamber. The method further comprises measuring a component level in the exhaust conduit; comparing, via the at least one controller, the component level to a target component level range; comparing to a rate of change target range; and based at least in part on whether the component level is within the component level target range and whether the rate of change is within the component level rate of change target range. It may include controlling the valve to open. The component level may be a carbon dioxide level, the component level target range may be a carbon dioxide level target range, and the component level rate of change target range may be a carbon dioxide level rate of change target range. .

A first conduit system inspiratory intake conduit may extend from the expiratory input interface toward the reservoir, and the method further comprises determining a flow rate of the exhaled breath along the expiratory intake conduit via a flow meter. may include the step of measuring The volumetric rate of increase of the volume of the container may be proportional to the flow rate. The method may further include directly mechanically controlling the volume of the container with the at least one controller. The container may include a piston chamber having an actuatable piston disposed therein, and the method may further include actuating a position of the piston within the piston chamber that defines the volume of the cavity. The method may further include controlling movement of the exhaled breath through a valve to the piston chamber. The method further includes controlling the valve to close and controlling actuation of the piston to propel the exhaled gas within the cavity through a subset of at least one sorbent tube connected to the reservoir. may include the step of

The container may include an at least partially flexible collapsible receptacle, and the method further comprises: exhaling the at least partially flexible collapsible receptacle via a pump disposed intermediate the exhalation input interface and the container. propelling the exhaled air at the rate of volume increase into a collapsible receptacle of the .

Other technical advantages will be readily apparent to one of ordinary skill in the art upon examination of the following figures and descriptions.

For a better understanding of the embodiment(s) described herein, and the embodiments (
In order to show more clearly how may be implemented, reference will now be made, by way of example only, to the accompanying drawings.

Fig. 2 shows a breath sampling device according to one embodiment thereof; Figure 2 is a schematic diagram showing a sorbent tube for use with the apparatus of Figure 1; 2 is a flow chart of a general method of collecting exhaled breath using the device of FIG. 1; Figure 2 shows the breath sampling device of Figure 1 with ambient air being drawn into the piston chamber; 4B shows the breath sampling device of FIG. 4A while flushing the device with ambient air; FIG. Figure 4B shows the sorbent tube installed in the breath sampling device of Figure 4A and ambient air being drawn into the container. Figure 4B shows ambient air being forced through one of the sorbent tubes in the breath sampling device of Figure 4A. Figure 4B shows the breath sampling device of Figure 4A as a person begins blowing into the breath sampling device; FIG. 4D shows the breath sampling device of FIG. 4C collecting a breath sample after the breath has been determined to be alveolar breath. FIG. 4D illustrates priming a breath sampling device using the breath sampling device of FIG. 4C. Figure 4D shows the breath sampling device of Figure 4C taking a breath sample after the sorbent tube has been loaded. FIG. 4C shows the breath sampling device of FIG. 4C running a collected breath sample through one of the sorbent tubes. 1 is a graph showing exhaled carbon dioxide levels over time. FIG. 10 shows the humidity level in the breath sampling device while the humidity is being removed by the pump. FIG. 3 illustrates a breath sample collection device including a folded bag and its operating environment, according to another embodiment. Figure 7B shows the device of Figure 7A with the bladder inflated. Fig. 10 shows a breath sampling device according to a further embodiment;

Unless otherwise noted, items depicted in the drawings are not necessarily drawn to scale.

For simplicity and clarity of illustration, reference numerals may be repeated among the figures to indicate corresponding or analogous elements, where considered appropriate. Moreover, numerous specific details are set forth to provide a thorough understanding of the one or more embodiments described herein. However, it will be understood by those skilled in the art that the embodiments described herein may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the embodiments described herein. Although exemplary embodiments are shown in the drawings and described below, it is first understood that the principles of the disclosure may be implemented using any number of techniques, presently known or not. should be understood. In no way should this disclosure be limited to the exemplary embodiments and techniques illustrated in the drawings and described below.

Various terms used throughout this specification may be read as follows, unless the context dictates otherwise. "Or" used throughout is inclusive as if written "and/or" and singular articles and pronouns used throughout include their plural forms and conversely includes the singular, and likewise, pronouns of a gender include their corresponding pronouns, so that the pronouns limit anything described herein to the use, practice, performance, etc., by a single gender. and "exemplary" should be understood as "illustrative" or "exemplifying" and not necessarily "preferred" over other embodiments. not understood. Further definitions of terms may be set forth herein, which may apply to antecedent and subsequent instances of those terms, as understood from a reading of this specification.

Modifications, additions, or omissions may be made to the systems, devices, and methods described herein without departing from the scope of the disclosure. For example, system and device components may be integrated or separated. Moreover, the operations of the systems and devices disclosed herein may be performed by more, fewer, or other components, and the methods described may be performed by more, fewer, or or other steps. Additionally, the steps may be performed in any suitable order. As used herein, "each" refers to each member of a set or each member of a subset of a set.

Any module, unit, component, server, computer, terminal, engine, or device illustrated herein that executes instructions may be stored on a storage medium, such as a magnetic disk, optical disk, or tape, computer storage medium, or data storage medium. Devices (removable and/or non-removable) may include or have access to computer-readable media. Computer storage media are volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules or other data may include Examples of computer storage media include RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, Digital Versatile Disc (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other It includes magnetic storage devices or any other medium that can be used to store desired information and that can be accessed by an application, a module, or both. Any such computer storage media may be part of, accessible to, or connectable to a device. Further, unless the context clearly dictates otherwise, any processor or controller defined herein may be implemented as a single processor or as multiple processors. Multiple processors may be arranged or distributed, and although a single processor is illustrated, any processing function referred to herein may be performed by one processor or may be performed by multiple processors. may be executed by a processor of Any method, application or module described herein may be stored or otherwise carried by such computer readable media and computer readable/executable instructions that may be executed by one or more processors. can be implemented using

A breath sampling device 20 according to one embodiment is shown in FIG. The breath sampling device 20 allows collection of breath samples into the sorbent tube asynchronously with when exhaled breath is provided. Breath sampling device 20 includes a container for receiving exhaled breath. Exhaled air is then flowed through one or more sorbent tubes asynchronously with respect to when exhaled air is received. Flowing exhaled gas through one or more sorbent tubes may be performed by creating a positive relative pressure differential to propel exhaled gas, by creating a negative relative pressure differential to draw in exhaled gas, or any other It can be done in any suitable way. As a result, adsorption of exhaled breath by the sorbent tube can be more tightly controlled.

Breath sampling device 20 includes a breath input interface 24 for receiving exhaled breath from a person. The breath input interface 24 includes a mouthpiece 36 that is secured to the breath intake end 40 of the breath intake conduit 44 of the pre-collection conduit system 46 .

Mouthpiece 36 is preferably made of inexpensive polypropylene or other suitably safe material so that it is disposable/replaceable. More preferably, the mouthpiece 36 does not offgas volatile organic compounds (“VOCs”) or offgas VOCs at a slow rate so as not to significantly contaminate the exhaled breath sample. Mouthpiece 36 may include a virus/bacteria filter to exclude bacteria and particulates from the sample. By making the mouthpiece 36 disposable, a new filter can be provided for each patient to avoid sample cross-contamination and transmission of viruses, bacteria, and the like.

The polypropylene of the mouthpiece 36 is clear and slightly cloudy in the presence of high humidity. Since it may not be desirable to have condensation within the breath sampling device 20, this feature can be used to visually detect condensation.

In other embodiments, the breath input interface may be configured to receive breath from other animals.

The breath sampling device 20 conduit is made of stainless steel coated with an inert coating. The inert coating may be made of any suitably inert material such as silica-based or quartz materials.

Exhaust conduit 48 is connected at its first end to exhalation intake conduit 44 and branches therefrom. A set of metering devices are positioned along the exhaust conduit 48 including a hygrometer 52 for measuring humidity within the exhaust conduit 48 . Condensation can degrade the functionality of the breath sampling device 20 in that the condensation traps components of the person's breath and thus does not accurately represent the collected breath sample. Additionally, certain levels of humidity and/or condensation can affect the functioning of other components of breath sampling device 20 . A capnometer 56 is positioned along the exhaust conduit 48 to measure the carbon dioxide content of the patient's breath. Also disposed along the exhaust conduit 48 is a flow meter 60 that measures the flow of expired air along the exhaust conduit 48 . A low pressure resistance portion 64 along the exhaust conduit 48 provides a low amount of resistance to gas flow along the exhaust conduit 48 toward the exhaust conduit outlet 68 at the second end of the exhaust conduit 48 . The low pressure resistance portion 64 acts as a cap over the exhaust conduit 48 to inhibit return diffusion gas from entering the exhaust conduit 48 while allowing gas to flow in both directions if desired. Any suitable structure may be used to provide the low pressure resistance portion 64, such as flexible or hinged flaps, sections of conduit having constricted cross-sections or change(s) of direction.

The air circulation system includes a pump conduit 76 branching from exhaust conduit 48 and terminating in a pump 72 driven by a motor. Pump 72 is configured to draw ambient air through exhaust conduit 48 and exhalation intake conduit 44, such as through mouthpiece 36, and expel it to the surrounding environment as needed. Any fluid pump suitable for use with gases may be employed.

The inner diameter size of mouthpiece 36 and conduit portions 44 , 48 are selected to provide little resistance to the exhalation of exhaled air through mouthpiece 36 . Additionally, the conduit portions 44, 48 can be heated or cooled as desired to control the formation of condensation therealong. This may be desirable to reduce the likelihood that condensation will pass into a breath sampling device such as a sorbent tube.

A breath collection valve 80 is connected to the breath intake conduit 44 and controls the flow of gas from the breath input interface 24 of the breath intake conduit 44 to the breath collection conduit 84 of the breath capture conduit system 82 . The breath intake conduit 44 forms part of the direct path between the breath input interface 24 and the breath capture conduit system 82 . Suction valve 88 controls the flow of gas into and out of exhaled breath collection conduit 84 via ambient air inlet 92 . An air filter 96 is positioned between the ambient air inlet 92 and the intake valve 88 to filter the incoming ambient air to reduce the ingress of particulate contamination therein.

The reservoir is in fluid communication with exhaled breath collection conduit 84 and is configured to store exhaled air received from the exhaled breath collection conduit. The container in this embodiment includes a piston chamber 100 having a cavity 104 therein defined at least partially by the inner walls of the piston chamber 100 . Piston chamber 100 has a capacity of 2 liters and may have any suitable cross-sectional shape. A piston 108 corresponds in shape to the piston chamber 100 , is arranged in the piston chamber 100 and is driven by a piston motor 112 . Piston 108 seals against the sides of piston chamber 100 to provide an airtight seal. Piston motor 112 may be any suitable type of motor that operates piston 108 within piston chamber 100 .

The volume of cavity 104 is directly mechanically controllable by positioning piston 108 within piston chamber 100 by piston motor 112 . Further, the rate of volume change of cavity 104 increases the volume of cavity 104 by actuating piston 108 within piston chamber 100 at a corresponding rate and moving further into piston chamber 100 to increase the rate of volume increase. It is controllable either by defining or moving further out of the piston chamber 100 to reduce the volume of the cavity 104 to define the rate of volume reduction.

In another embodiment, the piston chamber is configured with an interior space and the piston has a similar cross-sectional shape for slidable movement through the interior space of the piston chamber.

Breath collection conduit 84 is connected to tube manifold 116 . Tube inlet manifold 116 branches into four tube inlet valves 120 . Bypass conduit 124 branches from exhaled breath collection conduit 84 and has a bypass valve 128 disposed along bypass conduit 124 to prevent or allow gas flow therealong. Outlet valve 132 is positioned toward outlet 136 to control gas flow through outlet 136 . A tube outlet manifold 140 is connected to bypass conduit 124 and branches into four tube outlet valves 144 . Tube inlet valve 120 and tube outlet valve 144 have connectors for receiving sorbent tubes. In other embodiments, breath sampling device 20 may be configured to accept and use any number of sorbent tubes.

Controller 148 controls the operation of breath sampling device 20 . A controller 148 is connected to valves 80, 88, 120, 128, 132, and 144 to open and close these valves as described later herein. In other embodiments, the functions of controller 148 may be performed by more than one controller.

The display 150 is controlled by the controller 148 to present instructions and information to the person, as well as measures taken by the breath sampling device 20, such as completion of the procedure, an estimate of time remaining, and the like.

Internal components that are in contact with exhaled air are generally inert. Conduits and valves are made of stainless steel and have an inert coating. The sealing elements within the valve are made of FKM, a family of fluoroelastomer materials, or other suitable elastomeric material with a very low off-gas fraction. Polypropylene mouthpiece 36 may off-gas, but the level is within acceptable tolerance levels.

Referring now to FIG. 2, an exemplary sorbent tube 152 is shown. The sorbent tube 152 has a tubular stainless steel casing 156 defining openings 160 at each end thereof. Receiving end 164 of adsorbent tube 152 receives the gaseous fluid to be adsorbed. In the exemplary described embodiment, the gaseous fluid is human exhaled breath taken from a human for testing. A foam separator 168 is positioned toward the receiving end and is configured to distribute fluid pressure more evenly across the cross-section of the stainless steel casing 156 . Adsorbent material 172 is positioned adjacent to foam separator 168 and another foam separator 110 . The separator may alternatively be made of wire mesh or other suitable material. The adsorbent material 172 is highly porous, has a relatively high surface area, and is selected for sampling a particular compound to trap and retain the compound of interest even in the presence of other compounds. Additionally, the adsorbent material 172 allows the collected compounds to be easily desorbed or extracted for analysis. Furthermore, the solid adsorbent selected does not react with the sample. In a particular embodiment, the solid adsorbent is Tenax TA or a carbon material. As the gaseous fluid is received through receiving end 164 , the sample becomes more concentrated towards receiving end 164 of sorbent tube 152 . In other embodiments, the composition and configuration of the sorbent tube can vary, as will be appreciated by those skilled in the art.

A method 200 of collecting a breath sample using breath sampling device 20 will now be described with reference to FIGS. 1, 3, and 4A-4G.

Method 200 begins by drawing ambient air into the system (210). The system flushes out any stagnant residual air by drawing in ambient air and then exhausting it through conduits 44 , 48 , 68 , 76 , 84 , and 124 . This is done to ensure that there is no cross-contamination between the current sampled breath and the breath from the previous person. Stale room air in the system is replaced with fresh room air during this flushing.

First, it is verified that valves 80, 120 and 128 are closed. The controller 148 then commands the intake valve 88 to open and commands the piston motor 112 to operate to retract the piston 108 within the piston chamber 100 . As the piston 108 is retracted within the piston chamber 100, the volume of the cavity 104 defined by the inner wall of the piston chamber 100 and the piston 108 hermetically enclosed therein increases. As a result, the pressure within cavity 104 drops rapidly. Ambient air is drawn into cavity 104 through ambient air inlet and air filter 96 .

FIG. 4A shows cavity 104 filled with entrained ambient air. In the following, for purposes of explanation, open valves include stippling and closed valves have no stippling. Air filter 96 removes particulates from the ambient air as it is being inhaled and prior to entering breath collection conduit 84 . During this intake of ambient air, the breath collection valve 80 is closed, but traces of the previous person's breath may be present along the breath intake conduit 44 and along the exhaust conduit 48 . It is desirable to keep exhaled breath collection valve 80 closed so that only ambient air is taken in and filtered through air filter 96 .

Once ambient air is drawn into the piston chamber 100, it is used to flush the system (208). When the controller retracts the piston 108 within the piston chamber 100, the controller closes the intake valve 88 and then opens all other valves. When valves 80, 120, 128, 132, and 144 are opened, controller 148 directs piston motor 112 to drive piston 108 into piston chamber 100, directing ambient air there into the exhalation intake conduit. 44 to exit mouthpiece 36, through exhaust conduit 48 to exit exhaust conduit outlet 68, through exhaled breath collection conduit 84 and tube inlet manifold 116 to exit tube inlet valve 120, and It is urged out through bypass conduit 124 and tube outlet manifold 140 and out outlet 136 and tube outlet valve 144 . As a result, the conduits of the system are effectively filled with ambient air.

FIG. 4B shows flushing of breath sampling device 20 .

After the system has been flushed with ambient air, valves 80, 120, 132, and 144 are closed again.

Upon completion of flushing, controller 148 determines 212 whether to repeat flushing. The flushing is repeated 5-10 times with approximately 10-20 liters of air to reduce the probability that the exhaled breath of the previous person will contaminate the exhaled breath sample being collected. If it is determined that the required number of flushes has not yet been completed, controller 148 begins the process of drawing ambient air again at 204 .

Alternatively, if it is determined that sufficient flushing has occurred, one or more sorbent tubes 152a-152d (or hereinafter collectively referred to as sorbent tubes 152) are loaded 213 into breath sampling device 20. ). Bypass valve 128 and outlet valve 132 are closed. One to four sorbent tubes 152 are then loaded into the breath sampling device 20 .

In this embodiment, a sample of ambient air is used as a control against which breath samples can be compared. The ambient air that a person inhales while providing a breath sample may contain several compounds that are quantified during analysis of the breath sample. Ambient air can be adsorbed onto one or more sorbent tubes 152 to identify these compounds in the ambient air of the space in which the breath sampling device 20 is located. Breath sampling device 20 performs sampling of ambient air in a somewhat similar fashion to sampling of breath. Accordingly, at least two sorbent tubes 152 are loaded such that at least one is capable of capturing ambient air and at least another is capable of capturing exhaled air.

Once the sorbent tube is loaded, ambient air is drawn into the piston chamber 100 (214), as shown in FIG. 4C. Ambient air is drawn into the room in which the breath sampling device 20 resides by controlling the piston motor 112 to actuate the piston 108 . As piston 108 is retracted within piston chamber 100 , cavity 104 increases in size and ambient air is drawn into cavity 104 via inlet 92 through air filter 96 and inlet valve 88 .

As ambient air is drawn into piston chamber 100, it is channeled (215) through a subset of sorbent tubes 152, as shown in FIG. 4D. Controller 148 opens a first tube inlet valve of tube inlet valves 120 , a first tube outlet valve of tube outlet valves 144 , and outlet valve 132 . Controller 148 then directs piston motor 112 to actuate piston 108 and move it into piston chamber 100 to decrease the volume of cavity 104 . As the cavity volume decreases, ambient air within cavity 104 is forced through first sorbent tube 152 a and out through outlet 136 . The rate at which ambient air is flowed through adsorbent tube 152a is selected to provide effective adsorption while being time efficient.

If the target volume of ambient air to flow through sorbent tube 152a to capture the ambient air sample is determined to exceed the volume of the piston chamber (approximately 2 liters), then the ambient air sample is captured on sorbent tube 152a. , 214 and 215 are repeated as necessary.

The person 180 from whom a breath sample is to be collected is then instructed via the display 150 to exhale into the mouthpiece 36 during a process called "breath pre-collection," as shown in FIG. 4E ( 216). A “breath pre-sampling” is used to accustom the person 180 to the sensation of exhaling into the breath sampling device 20 in a predetermined manner according to established standards for operation of the breath sampling device 20 . Display 150 presents an indication to person 180 regarding a target exhalation volume of 20 liters per minute. By training the person 180 on how to exhale into the breath sampling device 20, the person 180 will typically have a more stable exhalation. A person typically becomes much better at controlling his or her exhalation volume after just one exhalation exercise. In addition, the exhaled breath provided during the exhaled breath pre-collection phase is used to prime the conduits of the system.

When exhaled breath collection valve 80 is closed, exhaled air exhaled by person 180 travels through exhaled intake conduit 44 and along exhaust conduit 48 .

During the breath pre-collection phase, the capnometer 56 samples the air to measure the level of carbon dioxide therein. Because the capnometer 56 samples the air frequently, the capnometer 56 can also measure the rate of change of carbon dioxide levels. A flow meter 60 measures exhaled air flow. Low pressure resistance portion 64 provides a very low flow restriction to exhalation by person 180 , exhaled air exiting through exhaust conduit outlet 68 .

Controller 148 constantly monitors the signals from capnometer 56 and flow meter 60 to determine if a set of breath collection criteria have been met. These breath collection criteria are: (a) the carbon dioxide level reported by the capnometer 56 is within a target range defined by a minimum threshold and an upper limit of infinity; (c) the expiratory flow rate is within the target range defined by the minimum and maximum flow thresholds; In this embodiment, the minimum flow threshold is 20 liters/minute and the maximum flow threshold is 25 liters/minute. Having the exhalation flow rate within the target range provides consistency in the exhalation provided by the person 180 . As will be appreciated, the target range can be said to be defined by a threshold at one boundary of the target range, since the other boundary can be logically satisfied, such as an infinite or zero boundary.

A first portion of the person's 180 exhaled breath includes air from the mouth and/or throat where oxygen/carbon dioxide exchange in the lungs has not occurred, thereby providing a higher percentage of oxygen. As person 180 continues to exhale, a greater portion of exhaled air is from the lungs where oxygen/carbon dioxide exchange occurs. As a result, carbon dioxide released from the blood stream becomes a larger concomitant portion (about 3-7%) of exhaled breath. The carbon dioxide level then hits the knee where the carbon dioxide rate of change drops sharply. This indicates that the air is exhaled from within the lungs rather than from the mouth or trachea. Such exhalation is called alveolar exhalation. In this embodiment, the carbon dioxide level target range is from 3% of exhaled breath to an infinite upper limit, and the carbon dioxide level rate of change target range is from 0% to 2% of exhaled breath per second.

FIG. 5 shows carbon dioxide levels over time in the exhaled breath versus threshold Ω. The rate of change of carbon dioxide level increases generally consistently until alveolar exhalation is exhaled, at which point the rate of change of carbon dioxide level declines significantly. This rate of change is reflected as knee K. The carbon dioxide level in exhaled breath then stabilizes.

In this configuration, the breath sampling criteria are as follows. Carbon dioxide levels are greater than or equal to 2% of threshold. This level is well above atmospheric levels, but below levels expected to be found in humans (eg, a minimum of 3% from people with reduced lung function). The rate of change of carbon dioxide level is below a predetermined threshold. In addition, expiratory flow rates exceed 20 liters per minute.

These three criteria often prevent exhaled breath collection from being triggered under less than ideal circumstances.

Once all three criteria are met, exhaled breath collection is initiated (224), as shown in FIG. 4F. When the three criteria are met, controller 148 opens exhaled breath collection valve 80 and directs piston motor 112 to drive piston 108 to increase the volume of cavity 104 as exhaled breath is received. Piston 108 is controlled to operate at a speed dependent on the flow rate reported by flow meter 60 to provide a rate of volume increase of cavity 104 . In this particular embodiment, the rate of increase in volume of cavity 104 achieved as a result of actuating piston 108 is proportional to the flow detected by flow meter 60 along exhaust conduit 48 . In other embodiments, the rate of volume change of cavity 104 may be varied in different ways as a function of the flow rate reported by flow meter 60 .

As the volume of cavity 104 increases, it becomes easier for person 180 to exhale due to the resulting pressure differential. If the person 180 is exhaling at 20 liters per minute, the increased volume of the cavity 104 will result in 16 liters per minute being drawn by the pressure differential in the system, so the person 180 will have the force required for 4 liters per minute. I am just exhaling. This can allow a person with a reduced ability to exhale forcefully to provide a breath sample, as can be the case with lung cancer and respiratory system disease.

As previously indicated, the flow meter 60 is normally downstream for the airflow to limit contamination of the currently collected breath sample with exhaled breath from previous breath sample donors that have adhered to the flow meter 60 . Positioned along the path. If the rate of actuation of the piston 108 and thus the cavity volume increase were fixed, some exhaled air would be expelled through the flow meter 60 when the person 180 exhaled faster. This can result in exhaled exhaled air escaping along the exhaust conduit 48 in a larger than desired amount and can cause problems if the flow rate is less than the cavity 104 volume growth rate.

In this configuration, controller 148 controls piston 108 to increase the volume of cavity 104 at a rate dependent on the flow rate measured by flow meter 60 . Specifically, the volume of cavity 104 is increased by four times the flow rate measured by flow meter 60 . That is, the increased volume of cavity 104 captures 80% of exhaled air received from person 180 .

A hygrometer 52 , a capnometer 56 , and a flow meter 60 are all positioned along an exhaust conduit 48 remote from the exhaled intake conduit 44 . These metering devices are capable of off-gassing VOCs. In addition, these metering devices can become contaminated by exhaled breath from a previously exhaled person. By placing these metering devices along the exhaust conduit 48, exhaled air flows along the exhaust conduit 48 away from the direct path along the exhaled intake conduit 44, thereby reducing contamination by other exhaled or off-gassed VOCs. be done. In addition, these metering devices and conduits are provided with inert internal coatings to reduce the probability of exhaled or off-gassed VOCs adhering to their internal surfaces, thereby reducing previously received exhaled and off-gassed VOCs.
further reduce the probability of contamination of breath samples by

A generally generally unrestricted exhalation rate is measured by moving a portion of the received exhaled air along exhaust conduit 48 along which hygrometer 52, capnometer 56, and flow meter 60 are disposed. can be This expiratory volume is equal to the flow rate measured by the flow meter 60 plus the rate of volume increase of the cavity 104 as measured based on the actuation speed of the piston 108 position. This exhaled volume can then be used to determine how quickly to increase the volume of cavity 104 . By keeping the rate of increase in the volume of cavity 104 below the measured exhalation volume, some exhaled air will always travel under exhaust conduit 48, allowing continuous monitoring of total exhalation volume.

This ratio of 80% of total exhaled volume is such that if a person's exhaled volume drops rapidly, it is unlikely that expiratory volume will be exceeded, and the volume increase rate of cavity 104 can be adjusted with a small lag. , the reaction time buffer was chosen with margin. If the volume growth rate of cavity 104 exceeds the person's exhaled volume, the pressure differential in the system will unnaturally draw exhaled air from the person, which can have undesirable consequences, drawing ambient air through the exhaust conduit outlet 68. there is a possibility.

Information regarding the overall dispense rate may be presented to the person 180 on the display 150 to encourage the person 180 to dispense within the target range or at least at the threshold velocity.

When the person 180 increases exhaled volume to the threshold of 25 liters/minute, the piston 108 is instructed by the controller to increase the volume of the cavity 104 so that 80% of exhaled breath is collected in the cavity 104. is actuated to move to

If the person 180 reduces the delivery rate, the piston velocity is adjusted such that the volume change in the cavity 104 is always less than the delivery rate, no air is drawn through the flow meter route, and exhalation is exhaled through the flow meter 60. ensure that it is possible to meter the flow rate of

When the flow detected by the flow meter 60 enters the flow end range, the movement of the piston 108 is stopped and the collection of exhaled breath in the piston chamber 100 is stopped. The flow end range in this embodiment is from a lower limit of infinity to 2 liters of exhalation per minute.

A person 180 may not have enough exhaled breath to fill the entire piston chamber 100 . Therefore, when the flow meter 60 reports that the exhaled volume has fallen below a certain value, the movement of the piston 108 and thus the collection of exhaled breath is stopped.

Controller 148 then determines whether the target volume for priming the system has been sampled (228). The breath sampler 20 collects 1 liter of breath to prime the system. If less than the target volume of 1 liter of breath has been collected, controller 147 controls breath sampling device 20 at 216 to perform a breath pre-sampling.

Alternatively, if it is determined at 228 that enough breath has been sampled to prime the system, then the sampled breath is used to prime the system (232), as shown in FIG. 4G. Controller 184 directs exhaled breath collection valve 80 to close and directs bypass valve 128 and outlet valve 132 to open. Additionally, piston motor 112 directs piston 108 to drive into piston chamber 100 , thereby decreasing the volume of cavity 104 . As the volume of cavity 104 decreases (ie, volume reduction rate), exhaled air contained in cavity 104 is propelled through exhaled breath collection conduit 84 , tube inlet manifold 116 , tube outlet manifold 140 , bypass conduit 124 , and outlet 136 . be done. These conduits are thereby primed with the sampled breath of the person 180 .

Once the capture conduit system 82 is primed, exhaled air is again sampled using the same general approach at 216-228. That is, breath pre-collection is performed again (240). During breath pre-collection, controller 148 determines whether exhalation criteria are met (244). If so, an exhaled breath is collected (248), as shown in FIG. 4H.

Next, it is determined whether the target volume of exhaled breath for adsorption has been sampled or whether the piston chamber 100 is full (252). If the target volume of exhaled breath for adsorption onto the sorbent tube(s) 152 has not yet been collected, and if the piston chamber 100 is not full, then additional exhaled breath is recollected starting from the exhaled pre-collection at 240. be. Person 180 is instructed to take another breath.

Alternatively, if it is determined at 252 that the target volume of exhaled breath has been taken or that the piston chamber 100 is full, exhaled breath is flowed through a second subset of sorbent tubes 152 (256). . FIG. 4I shows that the piston chamber 100 has been filled with exhaled air. Controller 148 is configured to control the flow of at least a portion of exhaled air from the reservoir to the subset of sorbent tubes 152 asynchronously with respect to when exhaled exhaled air is received. That is, the flow of exhaled air from the reservoir to the subset of sorbent tubes 152 can be performed independently of the timing of receiving an exhaled breath, apart from having to occur after receiving exhaled breath. A second subset may be any number of sorbent tubes 152 connected to breath sampling device 20 that are not adsorbed with ambient air. After priming the conduit, when the machine has collected a full piston chamber's worth of breath, the controller 148 closes the breath collection valve 80 and controls each of the tube inlet valves 120 to open the tube inlet valves 120 to their previous positions. Each of the tube inlet valves 120 may be left closed or open, or opened or closed to select a subset of sorbent tubes 152 through which at least a portion of the exhaled gas is flowed. In this embodiment, the controller 148 opens the corresponding one of the tube inlet valve 120 and the tube outlet valve 144 and the outlet valve 132 for the sorbent tube 152 on which the sample is adsorbed. Piston 108 is controlled by controller 148 to slowly move exhaled air thereat at a predetermined rate to push the exhaled air through the selected sorbent tube 152 .

As exhaled air is being flowed through the second subset of sorbent tubes 152, air is concurrently flowed through the pre-collection conduit system 46 to reduce internal condensation (260). Specifically, controller 148 controls pump 72 to turn on to draw ambient air from mouthpiece 36 and exhaust conduit outlet 68 through exhaust conduit 48 to help relieve condensation from the lines. Pump 72 acts to reduce the condensation/humidity within exhaust conduit 48 as the metering device does not function optimally under very humid conditions. The humidity level is monitored via the hygrometer 52 when the pump 72 is activated.

FIG. 6 shows a typical graph of humidity levels detected by hygrometer 52 over time. The humidity is at a first level h1 before the pump 72 is turned on at t1. A high level of condensation can be observed on the clear mouthpiece 36 . After the pump 72 is turned on, the rate of change of humidity is negative because the humidity decreases over time. When the rate of change of the humidity level is within the target rate of change range at time t2, the controller 148 determines that the pre-sampling conduit system 46 is relatively free of condensation and there is relatively little value in continuing to operate the pump 72. pump 7
End the operation of 2. This humidity level change rate target range is from -0.05% relative humidity per second to 0% relative humidity per second in this embodiment, but can vary in other scenarios. In this way, the breath sampling device 20 can perform maintenance during otherwise idle times. In other embodiments, this condensation reduction step may be performed through the use of a secondary external hygrometer based on the humidity level being outside the humidity level target range of zero to the ambient air humidity level. .

The rate at which exhaled air is flowed through sorbent tube 152 is 500 milliliters per minute. It has been found that the leakage capacity of the adsorbent tube 152 is affected by the adsorbent flow rate. The breakthrough volume is the volume in which half of the sample is trapped in the sorbent tube 152 and the other half flows into the opposite side of the sorbent tube 152 . At breakthrough capacity, the sorbent in sorbent tube 152 is such that sufficient surface area is used to facilitate passage of molecules as well as trapping of molecules. Increasing the exhaled air flow rate through the sorbent tube 152 reduces the leakage volume. This biases the trapped sample towards heavier molecules and less towards smaller molecules. By controlling the flow rate of exhaled air through adsorbent tube 152, the adsorption rate for a particular molecule can be controlled.

It is then determined whether the target volume has been flowed through the subset of sorbent tubes 152 (264). If the desired amount of exhaled air has not yet been flowed through the subset of sorbent tubes 152, the method 200 returns to 240 where more exhaled air is collected for flow through the subset of sorbent tubes 152. .

Upon determining that the target volume has been flowed through the currently selected sorbent tube 152, the controller 148 terminates the flow of exhaled air through the sorbent tube 152 via the tube inlet and outlet valves 120, 144 and closes the sorbent tube. Out of 152 exhaled air can begin to flow through another sorbent tube.

The breath sampling device 20 may be configured to select different size subsets of sorbent tubes for ambient air and breath samples. In a preferred embodiment, two sorbent tubes of ambient air samples and two sorbent tubes of breath samples are collected. In other embodiments, ambient air may not be sampled.

Although not explicitly shown, controller 148 is connected to each of the valves, hygrometer 52, capnometer 56, flow meter 60, pump 72, piston motor 112, and other components of breath sampling device 20. It should be understood that

In other embodiments, the controllable volume container may be any other structure for providing a controllable volume cavity. For example, in one particular embodiment, the container can include an accordion-like structure.

FIG. 7A shows a breath sampling device 300 according to another embodiment. Breath sampling device 300 recognizes that breath sampling device 300 employs bi-directional pump 304 and a container that includes at least partially flexible collapsible receptacle 308 in place of piston chamber 100 and piston 108. It is similar to the breath sampling device 20 of FIGS. 1 and 4A-4I except that it is similar to FIG. An at least partially flexible collapsible receptacle 308 is secured to bidirectional pump 304 , which in turn is secured to exhaled breath collection conduit 84 .

In this embodiment, the at least partially flexible collapsible receptacle 308 is a bag made of polyvinyl fluoride, a highly flexible material with high tensile properties. Polyvinyl fluoride is not impermeable, but has a suitably low permeability which does not significantly affect its performance in this application. Additionally, polyvinyl fluoride is relatively inert. Other suitably flexible, relatively non-porous, relatively inert materials may additionally or alternatively be used in other embodiments. Additionally, the receptacle may also include an inflexible portion.

At least partially flexible collapsible receptacle 308 has an internal cavity having a volume defined by the amount of fluid therein. In FIG. 7A, the at least partially flexible collapsible receptacle 308 is shown to have substantially no exhaled air or ambient air therein, and thus the cavity has substantially no volume. . In this folded state, the at least partially flexible folding receptacle 308 can be compressed to facilitate packaging.

Bi-directional pump 304 has a controllable flow rate and allows exhaled and/or ambient air to flow in both directions. A bi-directional pump 304 is controllable by controller 148 to draw exhaled air and/or ambient air from exhaled breath collection conduit system 82 into an at least partially flexible collapsible receptacle 308 and an at least partially flexible collapsible receptacle 308 . The exhaled air and/or ambient air is drawn into the exhaled air collection conduit system 82 from the collapsible receptacle 308 . Accordingly, the controller 148 can control the bi-directional pump 304 and, consequently, the at least partially flexible collapsible receptacle 308 to provide the same power as the piston chamber 100 , the piston motor 112 and the piston 108 . Can provide general functionality. That is, the controller 148 can control the volume of the at least partially flexible collapsible receptacle 308 through operation of the pump.

FIG. 7B illustrates that the bi-directional pump 304 draws exhaled air and/or ambient air into it, thus removing the cavity of the at least partially flexible collapsible receptacle 308 and the at least partially flexible collapsible receptacle 308 itself. 4 shows at least partially flexible collapsible receptacle 308 after expansion.

Breath sampling device 300 also differs in that instead of a display, it has an array of optical elements in the form of LEDs 312 and an audio speaker 316 . Flow notifications may be presented to the user via LEDs 312 . For example, the array of LEDs 312 may include a sequence of red LEDs, yellow LEDs, green LEDs, yellow LEDs, and red LEDs. If the flow rate of exhaled breath through the exhaled breath input interface 24 is too low, a corresponding red or yellow LED can be illuminated. If the flow of exhaled air through the exhaled breath input interface 24 is satisfactory, the green LED can be illuminated. Similarly, if the flow rate of exhaled breath through the exhaled breath input interface 24 is too high, a corresponding second red or yellow LED can be illuminated. In this way, the person can be visually shown how their expiratory flow rate compares to the target flow rate. Other types of optical elements may be employed in other embodiments.

Audio speaker 316 can be used in a similar manner, with flow notifications provided by different frequency clicks, different frequency sounds, different sounds, and the like.

FIG. 8 shows a breath sampling device 400 according to a further embodiment. In this embodiment, flow meter 60 is positioned along exhaled intake conduit 44 . The flow meter 60 thus measures the total exhaled breath volume along the inspiratory conduit 44 . During breath collection, controller 148 can control piston motor 112 to actuate piston 108 such that the rate of volume change of cavity 104 is set to the rate of flow measured by flow meter 60 . In a preferred embodiment, the volume change rate of cavity 104 is set at 80% of the flow measured by flow meter 60 during exhaled breath collection. Excess exhaled air flows along exhaust conduit 48 and exits exhaust conduit outlet 68 .

While in the above-described embodiments a capnometer is employed to measure the level of carbon dioxide in exhaled breath, other embodiments employ exhaled gas, such as what can be indicated when alveolar exhalation is being detected. Other types of metering devices can be employed to measure the levels of other ingredients therein. By detecting the levels of these other components and the rate of change of these levels, these metering devices can determine when alveolar exhalation is being detected. For example, the metering device measures the oxygen level in exhaled breath and detects that the change in oxygen level falls within a target rate of change range with a maximum rate of change threshold, indicating that alveolar exhalation is currently being detected. I can judge.

In other embodiments, other types of breath sample reservoirs may be employed apart from sorbent tubes. For example, solid-phase microextraction (“SPME”) fibers can alternatively be used to store exhaled breath samples. Another example is silica gel. Still other examples are chemical reactions that provide a visible indication (eg, Drierite turns purple in the presence of moisture) or powders that produce by-product chemicals that can be more easily analyzed later. Other types of breath sample storage devices will occur to those skilled in the art.

The volume of the container can be mechanically controlled in other ways. In one particular embodiment, the container can include bellows that can be actuated to expand and contract.

Although certain advantages have been listed above, various embodiments may include some, none, or all of the listed advantages.

Those skilled in the art will appreciate that many more alternative implementations and modifications are possible and that the above examples are merely illustrative of one or more implementations. Accordingly, the scope is to be limited only by the claims appended hereto.

20 breath sampler 24 breath input interface 36 mouthpiece 40 breath intake end 44 breath intake conduit 46 pre-collection conduit system 48 exhaust conduit 52 hygrometer 56 capnometer 60 flow meter 64 low pressure resistance section 68 exhaust conduit outlet 72 pump 76 pump conduit 80 Exhaled breath collection valve 82 Capture conduit system 84 Exhaled collection conduit 88 Intake valve 92 Ambient air inlet 96 Air filter 100 Piston chamber 104 Cavity 108 Piston 112 Piston motor 116 Tube inlet manifold 120 Tube inlet valve 124 Bypass conduit 128 Bypass valve 132 Outlet valve 136 Outlet 140 Tube Outlet Manifold 144 Tube Outlet Valve 148 Controller 150 Display 152 Adsorbent Tube 156 Stainless Steel Casing 160 Orifice 164 Receiving End 168 Foam Separator 172 Adsorbent 176 Foam Separator 180 Person 200 Method 204 Drawing Ambient Air 208 Flushing Device 212 repeat flushing?
213 Load sorbent tubes 214 Draw ambient air 215 Flow air through first subset of sorbent tubes 216 Exhale pre-collect 220 Expiratory criteria met?
224 Collect breath to prime system 228 Target volume?
232 Prime system with collected breath 236 Load sorbent tube 240 Breath pre-collection 244 Exhalation criteria met 248 Collect breath 252 Is target volume or container full?
256 Flow expired air through sorbent tube(s) 260 Flow air through pre-collection conduit system to reduce condensation 264 Target volume?
300 breath sampler 304 bi-directional pump 308 flexible collapsible receptacle 312 LED
316 speaker

Claims (21)

A breath sample collection device comprising:
a breath input interface configured to receive exhaled breath;
a container connected to the breath input interface for receiving at least a portion of the exhaled breath, the container having a cavity of controllable volume;
at least one controller configured to control the volume of the cavity to increase at a rate of volume increase at most equal to the flow rate of the exhaled breath received by the breath input interface. Device. A first conduit system breath intake conduit extends from the breath input interface towards the container, a first conduit system exhaust conduit branches at its first end from the breath collection portion, and its second 2. The device of claim 1, having an outlet at the end of the. 3. The apparatus of claim 2, further comprising a flow meter positioned to measure flow along said exhaust conduit. 4. The apparatus of claim 3, wherein said rate of volume increase of said volume of said vessel is proportional to said flow rate along said exhaust conduit. 5. The apparatus of claim 4, wherein said volume of said container is directly mechanically controllable by said at least one controller. 6. The apparatus of claim 5, wherein the container comprises a piston chamber having an actuatable piston disposed therein, the position of the piston within the piston chamber defining the volume of the cavity. 7. The apparatus of Claim 6, further comprising a valve positioned to control movement of said exhaled breath into said piston chamber. Further comprising at least one sorbent tube connected to the vessel, the at least one controller controlling the closing of the valve, controlling the actuation of the piston, and the at least one sorbent tube. 8. The apparatus of claim 7, configured to propel the exhaled air within the cavity through a tube. The container includes an at least partially flexible collapsible receptacle, and the device is further configured intermediate the respiratory input interface and the container to allow the breath to flow at the volume increase rate to the at least partially flexible receptacle. 5. The device of claim 4, comprising a pump for urging into the flexible collapsible receptacle. further comprising at least one sorbent tube connected to the at least partially flexible collapsible receptacle, wherein the at least one controller controls the pump to control the at least one sorbent tube; 10. The device of claim 9, configured to propel the exhaled air within the cavity through a subset of . 11. The apparatus of claim 10, further comprising a valve positioned to control movement of said exhaled breath into said piston chamber. 5. The device of claim 4, further comprising a valve positioned to control movement of said exhaled breath into said piston chamber. further comprising a metering device positioned to measure a component level within the exhaust conduit, the at least one controller determining whether the component level is within a target component level range; determining whether the rate of change is within the component level rate of change target range, whether the component level is within the component level target range, and whether the rate of change is within the component level rate of change target range. 13. The apparatus of claim 12, configured to control the opening of the valve based at least in part on how. said metering device is a capnometer, said component level is a carbon dioxide level, said component level target range is a carbon dioxide level target range, and said component level rate of change target range is a carbon dioxide level rate of change target range; 14. Apparatus according to claim 13. an exhalation intake conduit of a first conduit system extending from the exhalation input interface toward the container;
2. The device of claim 1, comprising a flow meter positioned to measure the flow rate of the exhaled breath along the expiratory intake conduit. 16. Apparatus according to claim 15, wherein the rate of volume increase of the volume of the container is proportional to the flow rate along the expiratory intake conduit. 17. The apparatus of claim 16, wherein said volume of said container is directly mechanically controllable by said at least one controller. 18. The apparatus of claim 17, wherein the container comprises a piston chamber having an actuatable piston disposed therein, the position of the piston within the piston chamber defining the volume of the cavity. 19. The device of claim 18, further comprising a valve positioned to control movement of said expired air into said piston chamber. Further comprising at least one sorbent tube connected to the vessel, the at least one controller controlling the closing of the valve, controlling the actuation of the piston, and the at least one sorbent tube. 20. The apparatus of claim 19, configured to propel the exhaled air within the cavity through a subset of tubes. The container includes an at least partially flexible collapsible receptacle, and the device is further configured intermediate the expiratory force interface and the container to fold the at least partially flexible fold at the volume increase rate. 17. The device of claim 16, comprising a pump to propel the expired air into the receptacle.

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