DEVICES, METHODS, AND SYSTEMS TO COLLECT, STORE, AND ANALYZE CHEMICAL SUBSTANCES

TECHNICAL FIELD

The present disclosure pertains to collection, storing, and analysis tools, and the like. More particularly, the present disclosure pertains to devices and systems for collecting, storing, and analyzing chemical substances, and methods for manufacturing and using such devices.

BACKGROUND

A wide variety of medical devices have been developed in the medical field for collection, storing, and analysis of samples. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages.

BRIEF SUMMARY

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. Although it is noted that collection, storing and analysis approaches and systems are known, there exists a need for improvement on those approaches and systems.

An example detector may include a detector array configured to detect one or more parameters of at least one analyte from a target location of a subject's anatomy and a structure configured to orient the detector array adjacent the target location of the subject's anatomy and expose the detector array to analyte from the target location.

Alternatively or additionally to any of the embodiments in this section, the structure is a substrate and the detector array may be located on the structure.

Alternatively or additionally to any of the embodiments in this section, the structure may be a hydrophobic, gas permeable material.

Alternatively or additionally to any of the embodiments in this section, the structure may be configured to engage the subject's anatomy.

Alternatively or additionally to any of the embodiments in this section, the structure is flexible.

Alternatively or additionally to any of the embodiments in this section, the detector may include a cover extending over at least the detector array.

Alternatively or additionally to any of the embodiments in this section, the cover may be secured to the structure and the structure is a target facing component configured to engage the subject's anatomy.

Alternatively or additionally to any of the embodiments in this section, the cover may be transparent.

Alternatively or additionally to any of the embodiments in this section, the cover may be configured such that the detector array is analyzable through the cover.

Alternatively or additionally to any of the embodiments in this section, the detector array may be configured to be secured at a location relative to the target location of the subject's anatomy.

Alternatively or additionally to any of the embodiments in this section, the detector may include a band configured to be worn by the subject against skin of the subject and wherein the detector array and the structure are incorporated into the band such that the detector array may be exposed to the target location of the subject's anatomy through the structure when the band is worn by the subject.

Alternatively or additionally to any of the embodiments in this section, the band may form at least part of the structure.

Alternatively or additionally to any of the embodiments in this section, the detector may include a wound dressing configured to cover at least a portion of the detector array.

Alternatively or additionally to any of the embodiments in this section, the detector array may be a colorimetric sensor array (CSA).

Alternatively or additionally to any of the embodiments in this section, the detector array may have a control pattern having a first configuration and an analyte sensitive pattern having a second configuration that is at least substantially similar to the first configuration, the control pattern may be configured to be non-reactive to analytes from the subject, and the analyte sensitive pattern may be configured to react to analytes from the subject.

In a further example, a detector device may include a housing component and a detecting component at least partially covered by the housing component, and wherein the detecting component may be configured to detect one or more parameters of at least one analyte from a target location on a subject's anatomy and the housing component is flexible.

Alternatively or additionally to any of the embodiments in this section, the housing component may be at least partially transparent.

Alternatively or additionally to any of the embodiments in this section, the housing component may include a target facing component and a cover component coupled to the target facing component.

Alternatively or additionally to any of the embodiments in this section, the cover component may be at least partially transparent.

Alternatively or additionally to any of the embodiments in this section, the target facing component may be a gas permeable membrane.

Alternatively or additionally to any of the embodiments in this section, the target facing component may be a gas impermeable membrane.

Alternatively or additionally to any of the embodiments in this section, the target facing component may be a hydrophobic membrane.

Alternatively or additionally to any of the embodiments in this section, the target facing component may be configured to direct a fluid flow including the at least one analyte from the target location of the subject's anatomy to the detecting component.

Alternatively or additionally to any of the embodiments in this section, the detecting component may have an array of analyte sensitive material configured to chemically react to the at least one analyte.

Alternatively or additionally to any of the embodiments in this section, the array of analyte sensitive material may be applied to a substrate.

Alternatively or additionally to any of the embodiments in this section, the substrate may be secured to the housing component.

Alternatively or additionally to any of the embodiments in this section, the housing component may comprise a cover.

Alternatively or additionally to any of the embodiments in this section, the detecting component may be configured to passively detect the one or more parameters of at least one analyte from a target location on a subject's anatomy.

An example method of detecting analytes from a target location of a subject's anatomy may include preparing a surface of the target location of the subject's anatomy for detection of analytes from the target location, positioning a detector at a desired location and exposing a detecting component of the detector to analytes from the target location, the detecting component including a substrate and analyte sensitive material applied to a side of the substrate facing away from the target location, and analyzing the analyte sensitive material of the detecting component after the detecting component is exposed to the analytes from the target location.

Alternatively or additionally to any of the embodiments in this section, the detector may be configured to detect one or more parameters of an analyte from skin of the subject and the target location is on a surface of the skin.

Alternatively or additionally to any of the embodiments in this section, the desired location may be a wound on the subject.

Alternatively or additionally to any of the embodiments in this section, positioning the detector at the desired location may include securing the detector at the desired location.

Alternatively or additionally to any of the embodiments in this section, securing the detector at the desired location may include securing the detector at the desired location with a band.

Alternatively or additionally to any of the embodiments in this section, securing the detector at the desired location may include securing the detector at the desired location with an adhesive configured to adhere to skin of the subject.

Alternatively or additionally to any of the embodiments in this section, removing the detector from the desired location may include removing the detector after a predetermined time at which the adhesive no longer adheres to the skin.

Alternatively or additionally to any of the embodiments in this section, the detector may be configured to be analyzed to identify analytes indicative of bacteria in a wound.

Alternatively or additionally to any of the embodiments in this section, the detector may be configured to be analyzed to identify analytes indicative of the subject's response to a therapy.

Alternatively or additionally to any of the embodiments in this section, the detector may be configured to be analyzed to identify analytes indicative of the subject's wellness.

Alternatively or additionally to any of the embodiments in this section, the detector may be configured to chemically react with the analytes and change colors to identify one or more parameters of the analytes.

Alternatively or additionally to any of the embodiments in this section, exposing the detecting component to analyte from the target location may include passively exposing the detecting component to analyte from the target location.

Alternatively or additionally to any of the embodiments in this section, exposing the detecting component to analyte from the target location may include pumping fluid including the analyte across the detecting component.

Alternatively or additionally to any of the embodiments in this section, the detector may include a hydrophobic, gas permeable component positioned between the desired location and the detecting component.

The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:

FIG. 1 is a schematic perspective view of an illustrative detector on a subject's anatomy;

FIG. 2 is a schematic cross-sectional view of the illustrative detector of FIG. 1, taken along line 2-2;

FIG. 3 is a schematic top view of an illustrative detector;

FIG. 4 is a schematic bottom view of an illustrative detector;

FIG. 5 is a schematic top view of an illustrative detector;

FIG. 6 is a schematic end view of the illustrative detector depicted in FIG. 5;

FIG. 7 is a schematic top view of an illustrative detector;

FIG. 8 is a schematic cross-sectional view of the illustrative detector of FIG. 7, taken along line 8-8;

FIG. 9 is a schematic perspective view of an illustrative detector including a band or strap on a subject's anatomy;

FIG. 10 is a schematic top view of an illustrative detector on a subject's anatomy;

FIG. 11 is a schematic cross-sectional view of the illustrative detector on the subject's anatomy of FIG. 10, taken along line 11-11;

FIG. 12 is a schematic bottom view of the illustrative detector depicted in FIG. 10;

FIG. 13A is a schematic top view of an illustrative detector prior to exposure to analyte;

FIG. 13B is a schematic top view of the illustrative detector of FIG. 13A after exposure to analyte;

FIG. 14 is a schematic top view of an illustrative detecting component;

FIG. 15 is a schematic top view of an illustrative detecting component;

FIG. 16 is a schematic top view of an illustrative detecting component;

FIG. 17 is a schematic top view of an illustrative detecting component;

FIG. 18 is a schematic top view of an illustrative mask component for use with the detecting component of FIG. 17;

FIG. 19 is a schematic side view of the illustrative mask component depicted in FIG. 18;

FIG. 20 is a schematic top view of an illustrative detector;

FIG. 21 is a schematic end view of the illustrative detector depicted in FIG. 20;

FIG. 22 is a schematic cross-sectional view of the illustrative detector of FIG. 20, taken along line 22-22;

FIG. 23 is a schematic cross-sectional view of an illustrative detector;

FIG. 24 is a schematic bottom view of the illustrative detector of FIG. 23;

FIG. 25 is a schematic side view of the illustrative detector of FIG. 23 in communication with a pump;

FIG. 26 is a schematic side view of an illustrative detector in communication with a pump;

FIG. 27 is a schematic top perspective view of an illustrative detector;

FIG. 28 is a schematic cross-sectional view of the illustrative detector of FIG. 27, taken along line 28-28;

FIG. 29 is a schematic exploded view of the illustrative detector of FIG. 27;

FIG. 30 is a schematic bottom perspective view of a base of the illustrative detector of FIG. 27;

FIG. 31 is a schematic bottom perspective view of a cover component of the illustrative detector of FIG. 27;

FIG. 32 is a schematic perspective of the illustrative detector of FIG. 27 in communication with a pump;

FIG. 33 is a schematic perspective view of an illustrative detector;

FIG. 34 is a schematic exploded view of the illustrative detector depicted in FIG. 33; and

FIG. 35 is a schematic flow diagram of an illustrative method of detecting analytes from a target area of a subject's anatomy.

While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

All numeric values are herein assumed to be modified by the term “about”, whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.

It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.

The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same or have similar tens and ones value, but a different hundreds value that is associated with a Figure number (e.g., a first configuration depicted in FIG. 1 of a component may have a reference number of 1XX and a second configuration depicted in FIG. 6 of the component may have a reference number of 6XX). The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

Chemical substances (e.g., analytes) migrate from inside a subject's body to an exterior surface of the subject's anatomy (e.g., a skin surface or other suitable surface) by diffusion across the epidermis from cutaneous capillaries, sweat glands (eccrine, and apocrine glands), and sebaceous glands. In addition, the epidermis of the skin continuously sheds thousands of cells into the environment, which are replaced by differentiating cells from the layer below. These dead cells transport body secretions and importantly bacteria, which act on the dead cells and envelope them in a minute vapor cloud. Example substances emitted, excreted, emanated, released, and/or secreted from, to, or through the exterior surface of a subject's anatomy include, but are not limited to, sweat, water, minerals, natural compounds, xenobiotic compounds, sebum, protein degradation products, volatile organic compounds (VOCs), and/or other suitable substances emitted from, to, or through the skin surface. Through changes in metabolic profiles of chemical substances produced by the body, physiological and pathological information may be identified.

VOCs are chemical compounds containing carbon that have a high enough vapor pressure under normal conditions to significantly vaporize and enter the atmosphere. VOCs and other chemical substances are produced from sweat and sebum as well as and in addition to their interactions with resident skin or wound bacteria. VOCs are continuously being produced by a mammalian body's metabolism, including the metabolism of the human body, and released into the air predominantly via skin, breath, feces, and urine. Thus, VOCs can instantaneously reflect normal or abnormal physiological and pathological biochemical processes occurring in the body at a time of measurement.

A complex profile of VOCs and/or other chemical substances emanates from exterior surfaces of human anatomy (e.g., skin, wounds, etc.), which is altered by changes in the body's metabolic or hormonal state, the external environment, and the bacterial species colonizing at the exterior surfaces. Based on this, bacterial biofilm formation in human ex vivo cutaneous wound models and their specific VOC profiles have been developed. These models and profiles provide a vehicle for human skin-relevant biofilm studies and VOC detection that has potential clinical translatability in efficient non-invasive diagnosis of wound infection, as discussed in Validation Of Biofilm Formation On Human Skin Wound Models And Demonstration Of Clinically Translatable Bacteria-Specific Volatile Signatures, Ashrafi M, Novak Frazer L, Bates M, Baguneid M, Alonso-Rasgado T, Xia G, Rautemaa-Richardson R, Bayat A, Sci Rep. 2018 Jun. 21; 8(1):9431, doi: 10.1038/s41598-018-27504-z), which is hereby incorporated by reference in its entirety for any and all purposes.

Capture and identification of VOCs and other chemical substances emanating from a target location of, on, or from a subject's anatomy (e.g., skin of a human body, wounds on the human body, feces or urine from the human body, exhalation from the human body, etc.) may be utilized for non-invasive, objective, and measurable monitoring and/or analysis of metabolic pathways, and can also illustrate how these pathways are altered and even respond to therapy in disease processes. For example, a change in a human body's metabolism equilibrium in response to a therapy can cause an alteration of VOCs and/or other chemical substances produced from the human body that is measurable and is indicative of how the human body is responding to the therapy.

In addition, microorganisms release VOCs and/or other chemical substances. The ability to identify these VOCs and/or other chemical substances from microorganisms in infected cutaneous wounds of a mammalian subject, such as a human being, results in efficient non-invasive diagnoses.

Diagnostic procedures utilizing VOCs and/or other chemical substances from a subject may be non-invasive and thus are an attractive alternative for patients compared to current invasive laboratory tests performed in hospitals and/or other medical settings, which take significant time and cannot provide instant point of care testing. In one example, use of VOCs to diagnose wound infections is discussed in Volatile Organic Compound Detection As A Potential Means Of Diagnosing Cutaneous Wound Infections, Ashrafi M, Bates M, Baguneid M, Alonso-Rasgado T, Rautemaa-Richardson R, Bayat A, Wound Repair Regen, 2017 August; 25(4):574-590. doi: 10.1111/wrr.12563, Epub 2017 Aug. 31, which is hereby incorporated by reference in its entirety for any and all purposes.

Various devices and system may be utilized to collect and/or analyze VOCs and/or other chemical substances. Some devices used for collection of VOCs and/or other chemical substances are configured to collect VOC onto an adsorption pad. Example devices used for collection of VOC and/or other chemical substances are described in PCT Patent Application No. PCT/US21/53167, filed on Oct. 1, 2021, and titled DEVICES, METHODS, AND SYSTEMS TO COLLECT, STORE, AND ANALYZE CHEMICAL SUBSTANCES, which is hereby incorporated by reference in its entirety for any and all purposes.

In order to analyze VOCs and/or other chemical substances collected on an adsorption pad, additional steps of transporting the VOCs and/or other chemical substances to an analysis system or location and desorbing the collected VOCs and/or other chemical substances from the adsorption pad may be required, which take time and can add complexity to the collection and analysis of VOCs and/or other chemical substances from a subject. Further, some devices or systems used for collection of VOCs and/or other chemical substances are configured to gather VOCs and/or other chemical substances by inhalation of air or other gasses mixed with VOCs and/or other chemical substances. Use of such devices or systems may result in obtaining a relative diluted mixture of gasses and VOC and/or other chemical substances, which may increase the difficulty of collecting and analyzing VOCs and/or other chemical substances that may be produced by a subject in relatively small volumes or concentrations. In some cases, VOCs and/or other chemical substances that are collected at a subject may need to be transported or moved to remote analysis locations, which has the potential to dilute and/or contaminate the collected VOCs and/or other chemical substances and adds to the complexity of the analysis and the length of time needed for the analysis of the collected VOCs and/or other chemical substances.

The disclosed concepts provide devices, systems, and methods that facilitate collection and analysis of analytes (e.g., VOCs and/or other chemical substances, etc.) from a target location on an exterior surface of a subject that may not require additional gasses or liquids to collect the VOCs and/or other chemical substances and that may facilitate analysis of the VOCs and/or other chemical substances at a collection site. In one example, the devices, systems, and methods that facilitate collection and analysis of VOCs and/or other chemical substances may include a device that incorporates a detector, where the device is configured to be located in proximity to an exterior surface of a subject's anatomy such that the detector may be exposed to VOCs and/or other chemical substances produced by the subject. In one example, the detector may be and/or may include a colorimetric sensor array (CSA), but this is not required.

Additionally or alternatively to devices, systems, and methods that facilitate collection and analysis of analytes from a target location on an exterior surface of a subject, the devices, systems, and methods described herein may be utilized to detect and/or analyze analytes from other suitable target locations of, on, or from the subject. For example, devices that facilitate analysis of and/or detection of analytes from a target location may be configured to detect analytes from exhalations (e.g., breath), urine, feces, throat cultures, wound cultures, and/or other suitable target locations of, on, and/or from the subject. In some cases, the target locations and/or analytes from the target locations may be obtained or collected from the subject and the devices, systems, and methods discussed herein may be utilized to detect and/or analyze such obtained or collected analytes or analytes from such obtained or collected target locations at a location remote from the subject or remote from the collection location.

Turning to the Figures, FIG. 1 depicts a schematic perspective view of an illustrative detecting device or detector 100 positioned on a surface 126 of a subject's skin 124 (e.g., a target location of the subject's anatomy). In one example, the detector 100 may be configured to detect analytes (e.g., VOCs and/or other chemical substances) from a mammalian body, such as a human or other animal patient or subject. In some cases, the detected analytes may be of the types emitted, secreted, emanated, released, and/or excreted to, from, or through skin 124 and/or other suitable anatomy of a subject.

The detector 100 may include one or more components. For example, the detector 100 may include one or more of a target facing component 111, a detecting component 113, a cover component 115, and/or one or more other suitable components as discussed herein or otherwise. Further, the functions and/or configurations of the target facing component 111, the detecting component 113, the cover component 115, and/or other suitable components of the detector 100 may be implemented in one or more physical components formed from one or more materials, as desired. In one example configuration of the detector 100, the detector 100 may include at least the detecting component 113 configured to detect analytes (e.g., VOCs and/or other chemical substances) emitted, secreted, emanated, released, and/or excreted to, from, or through the skin 124, wounds, and/or other suitable target locations of, on, or from the subject's anatomy, where the included detecting component 113 may or may not take on certain functions or configurations, discussed herein, of the target facing component 111 and/or the cover component 115.

The detector 100 may be configured in layers and may include any suitable number of layers, but this is not required, and other suitable configurations are contemplated. As depicted in FIG. 1, the detector 100 may include a first layer 112, a second layer 114, and a third layer 116. In some cases, the first layer 112 may be configured as the target facing component 111, the second layer 114 may be configured as the detecting component 113, and the third layer 116 may be configured as the cover component 115, but this is not required, and the detector 100 may have fewer than three layers, more than three layers, and/or layers formed from sub-layers.

The detector 100 may include a housing that is configured from one or more materials of the one or more layers or components or configured from one or more materials different than or separate from the one or more materials of the one or more layers or components. In some cases, the target facing component 111 and the cover component 115 may form a housing for the detecting component 113. Alternatively or additionally, a housing component may be configured to extend at least partially around one or more of, including all of, the target facing component 111, the detecting component 113, and the cover component 115 to house the components of the detector 100.

As depicted in FIG. 1, each of the target facing component 111, the detecting component 113, and the cover component 115 have a same or similar diameter. Other configurations of the target facing component 111, the detecting component 113, and the cover component 115 are contemplated. In one example, the detecting component 113 may have a diameter or dimensions that is less than a diameter or dimensions of the target facing component 111 and/or the cover component 115, such that the target facing component 111 and/or the cover component 115 may form a housing around the detecting component 113. In another example, the target facing component 111 and the detecting component 113 may have diameters or dimensions that are less than a diameter or dimensions of the cover component 115, such that the cover component 115 may extend around (e.g., cover) the target facing component 111 and the detecting component 113 to form a housing that may contact a surface of the target location and/or a surface adjacent the target location.

Further, the components of the detector 100 may be coupled together in any suitable manner. For example, the target facing component 111, the detecting component 113, the cover component 115, and/or other suitable components of the detector 100 may be attached or affixed to one another by use of adhesives, bonding techniques (e.g., ultrasonic welding, laser welding, etc.), heat staking, clips, mechanical clips, over molding, printing the component on another component, friction fits, interlocking features, one or more housings (e.g., as discussed above or otherwise), and/or other suitable coupling techniques.

The detector 100 may take on various suitable configurations. In one illustrative configuration of the detector 100, the target facing component 111 may be coupled to a first side of the cover component 115 and the detecting component 113 may be coupled to the first side of the cover component 115 within an inner circumference of the coupling between the target facing component 111 and the cover component 115. In a further illustrative configuration of the detector 100, the target facing component 111 may include a first side configured to face a target location and a second side opposite of the first side, the detecting component 113 may be coupled to the second side of the target facing component 111, and the cover component 115 may be coupled to the second side of the target facing component 111. In yet another illustrative configuration, the target facing component 111 may be omitted and the detecting component 113 may be coupled to a first side of the cover component 115, such that the detecting component 113 may be exposed to analytes (e.g., VOCs and/or other chemical substances) from the target location. In yet a further illustrative configuration, the cover component 115 may be omitted and the detecting component 113 may be coupled to the target facing component 111 at a side of the target facing component 111 opposite a side configured to face the target location. Other suitable configurations are contemplated.

When the components and/or layers of the detector 100 are affixed or coupled to one another, the components and/layers may be configured to be separated from one another and/or permanently secured to one another. In one example configuration of the detector 100 including the target facing component 111, the detecting component 113, and the cover component 115, the detecting component 113 may be separated from the cover component 115 and the target facing component 111 such that the detecting component 113 may be individually transported and/or analyzed. Such a configuration may allow for the re-use of all or some of the components of the detector 100 and/or inserting a new detecting component 113 into the detector 100. Additionally or alternatively, the detecting component 113 may be analyzed at the detector 100.

The detector 100 may take on any suitable shape, profile, aspect ratio, and size to accommodate various usability, clinical, manufacturing, packaging, marketing, etc. factors. As depicted in FIG. 1, the detector 100 may take on a circular profile, although other suitable shapes (e.g., rectangular, square, hexagonal, ovoid, irregular, etc.) may be utilized.

Further, the detector 100, individual components thereof, and/or portions of components may be rigid, compliant, and/or flexible. When the detector 100 is configured to contact the skin 124 of a subject and/or an area at or around another target location, the rigidity, compliance, and/or flexibility of the components of the detector 100 may be configured to create a desirable seal with the surface 126 of the skin 124 or area at or around another target location that facilitates detecting analytes from the exterior surface of the subject's anatomy (e.g., from a cutaneous surface or other suitable surface). In one example, the target facing component 111 may be a structure configured to orient the detecting component 113 adjacent the target location of the subject's anatomy and expose the detecting component 113 to analyte from the target location, and as such, may be configured to be compliant so as to conform to the surface 126 of the skin 124 or other anatomy of the subject. Further, a compliant and/or flexible detector 100 may facilitate manually creating gas turbulence within the detector 100 by applying manual oscillating pressure to the cover component 115 to mix analytes and promote circulation and efficient contact of analytes with the detecting component 113.

The components 111, 113, 115 and/or layers 112, 114, 116 of the detector 100 may be formed from any suitable materials or combinations of materials. Example materials include, but are not limited to, woven material (e.g., a material formed from a matrix of threads and/or other suitable woven material), porous materials, non-porous material, fabric, paper, filter material, plastic, rubber, glass, metal, aluminum, polymer, polyolefin, silicone, calcium sodium phosphosilicates (e.g., bioglass), bioceramic, polycarbonate, polypropylene, polyethylene terephthalate (PET), coatings, other suitable materials, and/or composites or combinations thereof. Further, the material of the components of the detector 100 may be configured to form a rigid detector 100, a flexible detector 100, a detector 100 having flexible portions, a detector 100 having rigid portions, and/or a detector 100 having one or more other suitably configured portions.

The components 111, 113, 115 of the detector 100 may each be formed from one or more one or more materials and may be formed from one or more sub-components or layers. In one example, a component 111, 113, 115 of the detector 100 may be formed from two or more layers (e.g., where the layers are entirely or at least partially overlapping) or adjacent sub-components (e.g., where the sub-components are entirely or at least partially non-overlapping) of a same material. In another example, a component 111, 113, 115 of the detector 100 may be formed from two or more layers or sub-components, where at least one material is different from another material of the layers or sub-components. In an example of the detecting component 113 including at least two or more layers or sub-components with at least one layer or sub-component formed from a first material different from a second material of another layer or sub-component, the first material may be an analyte sensitive material configured to detect a first type of analyte and the second material may be an analyte sensitive material configured to detect a second type of analyte, but this is not required.

The target facing component 111 may be formed from any suitable material. Example materials used for forming the target facing component 111 include, but are not limited to, plastic, rubber, glass, metal, aluminum polypropylene, polytetrafluorethylene, PET foam, polyurethane foam, reticulated foam, adhesive foam, gas permeable materials, gas impermeable materials, other suitable materials, and/or combinations thereof. In one example, the target facing component 111 may be formed from polypropylene and may form a hydrophobic, gas permeable membrane between the detecting component 113 and a target location, but this is not required. Forming the target facing component 111 at least partially of a hydrophobic, gas permeable membrane may allow for gasses containing analytes to reach the detecting component 113, while preventing contamination of the detecting component 113 from liquids at or adjacent the target location. Additionally or alternatively to forming the target facing component 111 from a hydrophobic, gas permeable membrane, the target facing component 111 may include vent holes define an opening between the target location and the detecting component 113, or include other suitable openings, to facilitate gaseous analytes passing (e.g., permeating) from the target location to the detecting component 113. In some cases, the target facing component 111 may be formed from a gas and/or liquid impermeable material to facilitate creating a seal (e.g., a hermetic seal or other suitable seal) with the cover component 115 at and/or around the target location to isolate the analytes emanating from the target location within the detector 100 for detecting by the detecting component 113.

Further, the target facing component 111 may be entirely or at least partially flexible, pliable, and/or rigid. In one example, the target facing component 111 may be at least partially flexible, pliable, or compliant so as to conform to a surface of a subject's anatomy (e.g., conform to a surface of a subject's arm). In some cases, a flexible, pliable, or compliant target facing component 111 may facilitate creating a seal with a subject's anatomy and isolating the analytes emanating from the target location within the detector 100.

The cover component 115 may be formed from any suitable material. Example materials used for forming the cover component 115 include, but are not limited to, plastic, rubber, glass, metal, aluminum, polymer, polyolefin, silicone, calcium sodium phosphosilicates (e.g., bioglass), bioceramic, polycarbonate, polypropylene, PET, polytetrafluorethylene, other suitable materials, and/or combinations thereof. In some cases, the cover component 115 may be porous, may be gas permeable, may have vent holes, may have a port, and/or otherwise be configured to facilitate a flow of fluid containing analytes through the detector 100. Alternatively or additionally, the cover component 115 may be non-porous to facilitate maintaining analytes from a target location within the detector 100 for detection.

In one example configuration, the cover component 115 may be a transparent (e.g., clear or otherwise transparent to human eyes and/or viewing technologies) material (e.g., a transparent polymer material and/or other suitable material) that may allow for viewing and/or analyzing the detecting component 113 through the cover component 115. A transparent or clear cover component 115 may facilitate heating the subject's anatomy through the cover component 115 using infrared light and/or other heating sources to increase analyte production from the subject's anatomy. Further, a material of a transparent or clear cover component 115 may be configured to provide optical magnification that is configured to magnify a view of analyte sensitive material of the detecting component 113 to help facilitate the analysis process through the cover component 115. Additionally or alternative, a transparent or clear cover component 115 may be configured as a filter so as to filter certain wavelengths of light and cause changes in analyte sensitive material of the detecting component 113 to be more readily viewable and/or understandable relative to not using a filter.

Further, the cover component 115 may be entirely or at least partially flexible, pliable, and/or rigid. In one example, the cover component 115 may be at least partially flexible, pliable, or compliant so as to facilitate the detector 100 conforming to a surface of a subject's anatomy (e.g., conform to a surface of a subject's arm). In some cases, a flexible, pliable, or compliant cover component 115 may facilitate isolating and/or producing the analytes emanating from the target location within the detector 100.

Although not depicted in FIG. 1, the target facing component 111, the cover component 115, and/or other suitable components of the detector 100 may include one or more openings. In some cases, the opening(s) may facilitate a fluid flow (e.g., air flow) through or across the detector 100, facilitate creating turbulence within the detector 100, etc., but this is not required. In one example, the cover component 115 may include a single opening extending through a top of the cover component 115, but configurations with additional or alternative opening configurations are contemplated.

Although not required, the opening of the cover component, when included, may be a vacuum port configured to engage a vacuum producing device via any suitable air-tight connection. In one example, the opening may be fitted or integrated with a nipple, protrusion, and/or other suitable component or configuration to facilitate connecting a vacuum tube or similar receptacle to the detector 100. The nipple, protrusion, and/or other suitable component or configuration may be made from any suitable materials including, but not limited to, polylactic acid and/or other suitable material to facilitate creating a pressure gradient that enhances a flow of analytes from a target location of or on the subject's anatomy to the detecting component 113.

The detecting component 113 may be configured from one or more materials that are selected for one or more purposes including to, but not limited to, detect or react in response to contact with one or more types of analytes (e.g., VOCs and/or other suitable chemical compounds from a target location). In one illustrative configuration, the detecting component 113 may include one or more analyte sensitive materials (e.g., a detector array) applied to one or more sides of a substrate. In one example, the detecting component 113 may be a colorimetric sensor array (CSA) or fluorometric sensor array (FSA), but this is not required, and other suitable arrays or configurations of analyte sensitive material are contemplated. Further, the materials of the detecting component 113 may be selected to form a detection component 113 that is entirely or at least partially rigid, pliable, and/or flexible. Alternatively or additionally, the detecting component 113 may be entirely or at least primarily configured from analyte sensitive material.

The substrate of the detecting component 113, when included, may be a structure configured to orient the analyte sensitive materials adjacent the target location of the subject's anatomy and expose the analyte sensitive materials to analyte from the target location, and may be formed from any suitable material. Example materials utilized for the substrate of the detecting component 113 include, but are not limited to, plastic, rubber, glass, paper, filter material, fabric, woven material, metal, aluminum, polypropylene, polytetrafluorethylene, other suitable materials, and/or combinations thereof. Further, the material utilized for the substrate of the detecting component 113 may be a solid material, a woven material, a hydrophobic material, a gas permeable material, a gas impermeable material, other suitable materials, and/or combinations thereof. In some cases, the substrate may have any suitable dimensional properties (e.g., pore size, diameter, area, volume, etc.)

In one example configuration of the substrate for the detecting component 113, the substrate of the detecting component 113 may be formed from a woven polypropylene material, which may result in a gas permeable, hydrophobic substrate. Although other pore sizes are contemplated, in the example configuration, the woven substrate may have an average pore size of or about 0.2 microns and a diameter of about 25 millimeters (mm). Such a configured substrate may facilitate applying the analyte sensitive material of the detecting component on a side of the substrate opposite a side facing a target location so that the hydrophobic material of the substrate mitigates the chances of and/or prevents liquid fluid from the target location contaminating the analyte sensitive material of the detecting component 113, while allowing analyte to reach the analyte sensitive material.

Additionally or alternatively, an example configuration of the substrate for the detecting component 113 may be fabricated from a hydrophobic, gas permeable material that has sufficient structural integrity to form the entire detector 100, along with the analyte sensitive material, (e.g., omit the target facing component 111 and the cover component 115, and/or other housing components). Such a configured substrate may be comprised of one or more gas permeable materials that provide a desired set of structural properties and gas permeability. In another example configuration of the substrate, the substrate may be formed entirely or at least in part by the cover component 115 and the analyte sensitive material may be applied to the cover component 115. In a further example configuration of the substrate, the substrate may be formed entirely or at least in part by the target facing component 111 and the analyte sensitive material may be applied to the target facing component 111.

The analyte sensitive material of the detecting component 113 may be formed from any suitable material. In some cases, the analyte sensitive material may be an optically responsive chemical material that changes color in response to detecting one or more analytes. Example analyte sensitive materials include dyes from, but not limited to, the following classes: Lewis acid/base dyes (e.g., metal on containing dyes), Brensted acidic or basic dyes (e.g., pH indicators), dyes with large permanent dipoles (e.g., solvatochromic dyes), redox responsive dyes (e.g., metal nanoparticle precursors), and/or other suitable classes of dyes. One example analyte sensitive material may be a silver nanoparticle material. Other suitable analyte sensitive materials are contemplated, including analyte sensitive material that is not a printed dye.

One or more analyte sensitive material(s) (e.g., dyes or other suitable materials) may be selected for the detecting component 113 based on a type of analyte (e.g., a VOC indicative of a bacteria or other condition) the detector 100 is configured to detect. For example, the analyte sensitive material(s) for the detecting component 113 may be selected so as to facilitate detecting analytes indicative of one or more types of bacteria or conditions including, but not limited to, pathogens, a subject's health, cancer, odor causing bacteria, microbiota conditions, pheromones, urinary tract infections, Streptococcus Pyogenes (SP), Methicillin Sensitive Staphylococcus Aureus (MSSA), Pseudomonas Aeruginosa (PA), and/or other suitable types of bacteria and/or conditions. In one example of analyte sensitive material of the detecting component 113, the analyte sensitive material may be an acid/base combination of dyes that is configured to detect analytes (e.g., propanol, butanol, undecane, ethanol, etc.) that may be given off, released, or otherwise produced in a response to a presence of Streptococcus Pyogenes.

Some detecting components 113 may be configured to include an analyte sensitive material that is reversible or semi-reversible. Reversible or semi-reversible analyte sensitive material may be utilized in detecting components 113 that may be configured for repeat monitoring, such as for continuous or periodic sensing of target locations to detect analytes from the target locations. Although other detecting components 113 are contemplated, example detecting components 113 including analyte sensitive material that is reversible or semi-reversible are discussed in U.S. Pat. No. 6,368,558 filed on Mar. 21, 2000, and titled COLORIMETRIC ARTIFICIAL NOSE HAVING AN ARRAY OF DYES AND METHOD FOR ARTIFICIAL OLFACTION; U.S. Pat. No. 6,495,102 filed on Nov. 11, 2000, and titled COLORIMETRIC ARTIFICIAL NOSE HAVING AN ARRAY OF DYES AND METHOD FOR ARTIFICIAL OLFACTION; U.S. Pat. No. 7,261,857 filed on Oct. 24, 2002, and titled COLORIMETRIC ARTIFICIAL NOSE HAVING AN ARRAY OF DYES AND METHOD FOR ARTIFICIAL OLFACTION; U.S. Pat. No. 8,852,504 filed on Oct. 11, 2007, and titled APPARATUS AND METHOD FOR DETECTING AND IDENTIFYING MICROORGANISMS, all of which are hereby incorporated by reference in their entirety and for all purposes.

Some detecting components 113 may be configured to include an analyte sensitive material that is irreversible. Irreversible analyte sensitive material may be utilized in detecting components 113 that are configured for single use monitoring or single use monitoring per analyte material when the detecting component 113 is configured to monitor for a plurality of different analytes, but this is not required. Although other detecting components 113 are contemplated, example detecting components 113 including analyte sensing material that is irreversible are discussed in U.S. Pat. No. 9,880,137 filed on Sep. 2, 2009, and titled COLORIMETRIC SENSOR ARRAYS BASED ON NANOPOROUS PIGMENTS; U.S. Pat. No. 10,539,508 filed on Jun. 9, 2015, and titled PORTABLE DEVICE FOR COLORIMETRIC OR FLUOROMETRIC ANALYSIS AND METHOD OF CONDUCTING COLORIMETRIC OR FLUOROMETRIC ANALYSIS; Li, Zheng, et al., “Ultrasensitive Monitoring of Museum Airborne Pollutants Using a Silver Nanoparticle Sensor Array”, ACS sensors 5.9 (2020): 2783-2791; Li, Zheng, and Kenneth S. Suslick, “Chemically Induced Sintering of Nanoparticles”, Angewandte Chemie 131.40 (2019): 14331-14334; LaGasse, Maria K., et al., “Colorimetric sensor arrays: Development and application to art conservation”, Journal of the American Institute for Conservation 57.3 (2018): 127-140, all of which are hereby incorporated by reference in their entirety and for all purposes.

The analyte sensitive material may be applied to the substrate of the detecting component 113 in any suitable manner. In one example, the analyte sensitive material may be applied to the substrate by printing the analyte sensitive material on the substrate. When printed, any suitable printing techniques may be utilized including, but not limited to, pin transfer, inkjet, silkscreen, and/or other suitable application techniques.

The analyte sensitive material may be applied to the substrate of the detecting component 113 randomly and/or to form one or more patterns. Example configurations of the analyte sensitive material applied to the substrate include, but are not limited to, grid patterns of rows and columns, concentric rings, color matching of a color of printed dye material with a color of a substrate material prior to interactions with analyte, patterns that result in identifiable shapes when the analyte sensitive material reacts to a particular analyte, other suitable configurations, and/or combinations thereof.

To increase analyte detection rates, the substrate on which the analyte sensitive material is applied and/or the analyte sensitive materials may be textured (e.g., with grooves or surface topographical undulations, woven patterns, etc.) so as to increase an effective surface area of the analyte sensitive material for detecting analytes. Such texturing may be applied to the target-contacting or facing surface (e.g., a bottom surface 120) of the detector 100 in any suitable technique including, but not limited to, via etching, thermoforming, pressure forming, molding, machining, weaving, three-dimensional printing, and/or other suitable techniques.

Further, the detector 100 may be used and/or configured to stimulate analyte production from a subject's anatomy. Any suitable technique may be utilized for inducing analyte production including, but not limited to, the techniques discussed herein.

The detector 100 may include and/or be used with skin penetrating agents, such as Transcutol®, polyethylene glycol 400 (PEG 400), polyethylene glycol 200 (PEG 200), menthol and salicylic acid, which, for example, may be utilized to enhance delivery of sweat stimulating chemical agents to the skin 124 of the subject. Alternatively or additionally, iontophoresis techniques can be employed to drive sweat inducing agents into the skin of a subject to increase sweat production. In some cases, gasses or other fluids may be pumped to the skin of the subject or other target location to induce a flow of analytes (e.g., VOCs and/or other chemical substances) from the subject.

In some cases, the detector 100 may include one or more heat producing components that may heat the surface 126 of the subject's skin 124 or heat a portion of the detector 100 (e.g., the bottom surface 120 and/or other suitable portion of the detector 100). When the heat producing component is included in the detector 100, the heating of the detector 100 may be controlled by a control of or separate from the detector 100. Examples of heat producing components include, but are not limited to, heating coils, resistive wires, surface mount (SM) resistors, Peltier temperature control components (e.g., which may be used to heat and/or cool)) and/or other suitable components. In one example incorporation of a heat producing component, the detector 100 may utilize one or more heating coils configured to heat the bottom surface 120 of the detector 100 and induce the subject to sweat at and/or proximate to the detector 100.

Further, the detector 100 may include one or more sensors, which may include or be in communication with a controller. For example, the detector 100 may include a temperature sensor, a humidity sensor, a pressure sensor, and/or one or more other suitable sensors. In one example, when the detector 100 includes a heat producing component, the detector 100 may include a temperature sensor and a pressure sensor, where the heat producing component may be configured to cease heating in response to a sensed temperature crossing a threshold, a sensed pressure crossing a threshold, and/or a sensed temperature crossing a temperature threshold and a sensed pressure crossing a pressure threshold.

FIG. 2 depicts a schematic cross-sectional view of the detector 100, taken along line 2-2 in FIG. 1. Arrow F depicts a flow of analyte from the subject's skin 124 to the detecting component 113.

In some cases, the bottom surface 120 of the detector 100 may be configured to contact and/or engage a surface at or adjacent to a target location, such as a subject's skin or wound or other suitable target location. In some cases, the bottom surface 120 and/or the target facing component 111 may be flexible or pliable to facilitate conforming to a shape of a surface of a subject's anatomy, but other configurations are contemplated including, but not limited to, target facing components 111 that are rigid and/or detectors 100 having an additional target contacting surface for conforming to a shape of the surface of the subject's anatomy.

Although not required, the bottom surface 120 may be configured to adhere to the subject's skin 124 or other surface at or adjacent to a target location such that the detector 100 may remain at a desired location after being initially placed. The bottom surface 120 may have any suitable configuration for adhering to a surface at or adjacent a target location (e.g., the surface 126 of the skin 124, the surface of or adjacent to a wound, etc.) including, but not limited to, a configuration that facilitates a suction connection, an adhesive (e.g., a biocompatible adhesive attached to, impregnated in, or deposited on the bottom surface 120 and/or other suitable adhesive applied in one or more additional or alternative manners)), and/or other suitable configuration. In one example, the target facing component 111 may be or may include an adhesive layer (e.g., an adhesive-backed ring and/or other suitable adhesive layer) to adhere to the surface 126 of the subject's skin 124 in order to create a seal and to hold the detector 100 in place during collection of VOCs and/or other chemical substances. When creating the seal, the adhesive layer may be configured to create an airtight seal (e.g., a hermetic seal) or approximately airtight seal that prevents ambient air from leaking past the seal into the detector 100 once a vacuum (e.g., negative pressure) is applied thereto or otherwise. In other configurations, non-hermetic seals and/or couplings may be utilized.

The detector 100 may be configured to adhere to a surface at or adjacent the target location (e.g., skin 124 of the subject or other surface) for any suitable length of time. In one example, the bottom surface 120 and/or other portions of the detector 100 may be configured to adhere to a subject's skin 124 or other suitable surface for at least a duration sufficient to allow analyte sensitive material to react to otherwise detect analytes from the subject. In some cases, a material adhering the detector 100 to the subject's skin 124 or other suitable surface may be configured to release or separate from the subject's skin 124 or other suitable surface after a predetermined time, but this is not required.

As depicted in FIG. 2, the bottom surface 120 may define a space or an opening 122 through a thickness of the target facing component 111 (e.g., first layer 112) to the detecting component 113 (e.g., the second layer 114) and/or the cover component 115. In some cases, the detecting component 113 may be gas permeable or otherwise include one or more openings such that a flow of analyte through the opening 122 in the target facing component 111 may reach analyte sensitive material of the detecting component 113, but this is not required.

In some cases, the opening 122 may define a sample area. When the detector 100 is applied to a subject's anatomy, the opening 122 and the sample area may be positioned around a target location of a subject's anatomy from which analytes are to be detected.

The opening 122 may be configured such that an inner profile or circumference of the target facing component 111 may take on a shape that complements (e.g., in the depicted example is concentric to) a shape of the outer profile or circumference of the target facing component 111 and/or the detector 100. Although FIGS. 3 and 4 (discussed below) depict the opening 122 as having a circular profile, other profiles or shapes for the opening 122 may be used and such profiles or shapes may or may not render or complement a similar outer profile of one or more of the target facing component 111, the detecting component 113, the cover component 115, and/or the detector 100.

Further, the bottom surface 120 of the detector 100 may include one or more portions that comprise one or more holes, channels, and/or other suitable voids configured to create a capillary action during use of the detector 100 to assist in drawing analytes and/or secretions from the target location of or on the subject toward the detecting component 113. When the target facing component 111 is so configured, negative and/or positive pressure (e.g., as discussed further, below) may or may not be utilized to draw fluid from the target location toward the detecting component 113.

In the configuration depicted in FIG. 2, the detecting component 113 may be sized to extend across an opening 122 at least partially defined by a bottom surface 120 of the target facing component 111 to facilitate detecting analytes emitted, excreted, secreted, emanated, or released from a target location of or on the subject's anatomy (e.g., the surface 126 of the subject's skin 124, a wound on the subject, etc.). In one example, the detecting component 113 may have a circular disc shape, but this is not required and other shapes are contemplated.

FIG. 3 depicts a schematic top view of an illustrative detector 100 having a circular configuration, but this is not required and other suitable shapes and/or configurations are contemplated. The detector 100 may include the cover component 115 (e.g., a transparent cover component 115, as depicted, or other suitable cover component 115), the detecting component 113, and the target facing component 111, where the cover component 115 is transparent and the detecting component 113 and the target facing component 111 may be viewed through the cover component 115 in a top view.

As depicted in FIG. 3, the target facing component 111 may be formed as a ring that has an outer circumference aligned with an outer circumference of the cover component 115. Further, the ring shape of the target facing component 111 may include an inner circumference having a diameter configured to facilitate analytes from the subject's anatomy reaching the detecting component 113. Although not required, when the target facing component 111 is applied to the subject anatomy, the inner circumference of the target facing component 111 may define the desired location (e.g., the sample area) at the target location on the subject's anatomy from which the analytes are to be detected.

The detecting component 113 depicted in FIG. 3 includes a plurality of dots formed from analyte sensitive material 128 on a substrate 130. As depicted, the dots are configured in rows and columns on the substrate 130 having a square configuration, but this is not required.

As discussed in greater detail below with various example configurations, the analyte sensitive material 128 may be applied to the substrate 130 so as to have any suitable configuration that can be visually understood and/or analyzed by human vision and/or computer vision techniques. Further, the analyte sensitive material 128 may be considered as a detector array, on its own, that is applied to the substrate 130 and/or the analyte sensitive material 128 applied to the substrate 130 and/or other suitable materials may be considered a detector array.

The substrate 130 may have any suitable shape as discussed or depicted herein and/or otherwise. In some cases, the substrate 130 may be a structure configured to orient the analyte sensitive material 128 adjacent the target location of the subject's anatomy and expose the analyte sensitive material 128 to analyte from the target location. For example, the substrate 130 may be applied to an area of or adjacent to the target location, the substrate 130 may be secured to or relative to the cover component 115 and/or the target facing component 111, etc. in such a manner that the analyte sensitive material 128 may be exposed to analyte from the target location.

The detecting component 113, as depicted in FIG. 3, may be coupled to the cover component 115. In some cases, the substrate 130 of the detecting component 113 may be coupled to the cover component 115 with any suitable coupling technique discussed herein or otherwise, while allowing for analysis of the detecting component 113 through the cover component 115, but this is not required.

FIG. 4 depicts a schematic bottom view of the illustrative detector 100 shown in FIG. 3, where the target facing component 111 at least partially defines the opening 122 through and in which analytes from the subject's anatomy are configured to travel to the detecting component 113. As depicted, a back surface of the substrate 130 may be viewed through the opening 122 defined by the target facing component 111. As the dots of the analyte sensitive material 128 are applied to the front surface of the substrate 130 in this configuration, the analyte sensitive material 128 is depicted in broken lines to indicate the analyte sensitive material 128 is applied to the front surface of the substrate 130 (or an opposite than is depicted in FIG. 4) and the analyte sensitive material 128 may or may not be viewed from the side or view depicted in FIG. 4. In some cases, however, the analyte sensitive material 128 may be applied to the back side of the substrate 130 in addition to or as an alternative to the front side. Alternatively or additionally, the analyte sensitive material 128 may be applied to one of the front side and the back side of the substrate 130 and due to a configuration of the substrate 130 (e.g., a woven material of the substrate 130 or other suitable configuration), the analyte sensitive material 128 may be absorbed into or through, may leak through, or otherwise move to the other of the back or front side and/or therebetween once it is applied to a side of the substrate 130 so as to increase a surface area of detection for the analyte sensitive material.

FIG. 5 depicts a schematic top view of an illustrative detector 100 having a rectangular shape and configured in a manner similar to the detector depicted in FIGS. 3 and 4. The detector 100 depicted in FIG. 5 may include a clear or transparent top layer 115 and a target facing component 111 having an outer circumference that aligns with an outer circumference of the cover component 115. Further, an inner circumference of the target facing component may define the opening 122 through which analyte may flow or travel to the detecting component 113.

Similar to as discussed with respect to FIGS. 3 and 4, the detecting component may include dots of analyte sensitive material 128 applied to the substrate 130. Although other configurations are contemplated, the analyte sensitive material 128 may be applied to the rectangular substrate 130 in rows and columns or in other suitable patterns. Further, the detecting component 113 may be affixed to the cover component 115 through any suitable coupling technique discussed herein or otherwise, such that the detecting component 113 response to analyte exposure may be analyzed through a transparent or clear cover component 115, as depicted in FIG. 5.

FIG. 6 depicts an end view of the detector 100 depicted in FIG. 5. As depicted in FIG. 6, the target facing component 111 extending between the bottom surface 120 and the cover component 115 and may have a height that is greater than a height of the cover component 115 and a height of the detecting component 113, but this is not required. In some cases, the height of the target facing component 111 may facilitate conforming the detector 100 to a subject's anatomy. Further, as depicted, the detecting component 113 may be affixed to the cover component 115 via any suitable coupling technique that facilitates or at least does not frustrate analysis of the detecting component 113 through the cover component 115.

FIG. 7 depicts a detector 100 that is configured in a manner that is similar to the detector 100 depicted in FIG. 5, however, the detector 100 in FIG. 7 includes supports 132 extending to or toward a plane of the bottom surface 120. In some cases, the supports 132 may extend through the opening 122 defined by the cover component 115 and the target facing component 111 to a surface on which the detector 100 is applied and facilitate maintaining a space or plenum between the detecting component 113 and the subject's anatomy or other surface to which the detector 100 may be applied. As depicted in FIG. 7, the detecting component 113 is positioned within the opening 122 and coupled to a transparent or clear cover component 115, such that the analyte sensing material 128 and the substrate 130 are viewable through the cover component 115.

FIG. 8 depicts a cross-sectional view of the detector 100 taken along line 8-8 in FIG. 7 and facing away from the detecting component 113 depicted in FIG. 7. As depicted, the detector 100 may include supports 132 formed by the cover component 115 that extend through the opening 122, which may be configured to contact a surface on which the detector 100 is applied and space the detecting component 113 from the surface when the detector 100 is applied thereto. Although the supports 132 are depicted as being formed by the cover component 115, it is contemplated that the supports 132 be formed from and/or be a component separate from the cover component 115.

In some cases, the detectors 100 depicted in FIGS. 1-8 and/or other detectors discussed herein may include a seal or release liner extending along the bottom surface 120 and over the opening 122 to keep the detecting component 113 sealed for protecting, not exposed to ambient conditions, sterile, and/or to otherwise maintain a virgin state and protect against contamination. The seal or release liner may be formed from any suitable material including, but not limited to, high-density polyethylene materials. Further, to protect the detecting component from contamination and/or for other suitable purposes, an inert gas (e.g., nitrogen, etc.) may be applied to the opening 122 and sealed therein by the seal or release liner, but this is not required.

When the detector 100 is to be applied to the subject's anatomy or other suitable surface and includes a seal or release liner, the seal or release liner may be removed from the bottom surface 120 and the bottom surface 120 may be applied to subject's anatomy such that analyte may travel from the surface through the opening 122 to the detecting component 113. In some cases, when the target facing component 111 forming the bottom surface 120 may be or may include adhesive material, the seal or release liner may be removed from the bottom surface 120 and the bottom surface 120 may be adhered to the subject's anatomy.

The detector 100 may be provided in a sterilized packaging (e.g., a sterilized double packaging, such as a pressure molded plastic tray with a cover made of TYVEK, which is a trademark for certain synthetic barriers that is owned by E. I. du Pont de Nemours and Company, and/or other suitable sterilized packaging). The detector 100 and/or the packaging may be sterilized using any suitable sterilization technique including, but not limited to, heat techniques, electron-beam techniques, gamma radiation techniques, ethylene oxide techniques, and/or other suitable sterilization techniques that may be suitable for use with detecting components 113.

Additionally or alternatively to the configurations of the detector 100 depicted in FIGS. 1-8, the detector 100 including at least the detecting component 113 may be formed as or may be incorporated in a band, strap, or other wearable component that is configured to be worn by a subject in contact with the subject's skin 124 or otherwise such that the detector 100 receives analytes from a target location of or on the subject's anatomy (e.g., the skin 124, a wound of the subject, etc.). Example bands, straps, and/or wearables include, but are not limited to, wristbands, waistbands, ankle bands, arm bands, leg bands, headbands, equipment strap, watchbands, headphones, hats, eyeglasses, helmets, a wound dressing, a bandage (e.g., for adherence directly over a wound and/or around a wound dressing), etc.

The detector 100 incorporated into or taking the form of a band, strap, and/or other wearable may facilitate applying the detector 100 to or at the target location, facilitate comfortably wearing the detector 100 for long periods of time to detect and/or interact with a desired volume of analytes to detect a presence of an analyte type, condition, bacteria, and/or pathogen, and/or may have one or more other suitable benefits. Further, once the detector 100 formed as a band, strap, and/or other wearable has detected and/or interacted with a desired amount of analytes from the subject wearing the detector 100, the subject or third party (e.g., family member, health care provider, technician, friend, etc.) may remove the detector 100 from the subject and analyze the detecting component 113 to determine which, if any, analytes were detected and/or place the detector 100 or a portion of the detector 100 (e.g., the detecting component 113) in contact with analytes from the subject into an appropriate container for transport and further analysis.

When the detector 100 is configured as or in a band, strap, or other wearable, the detector 100 or at least the detecting component 113 may be permanently integrated with the band, strap, or other wearable such that the detector 100 or at least the detecting component 113 cannot be removed from the wearable without destroying the wearable. When the detecting component 113 is permanently integrated with the band, strap, or other wearable, the analyte sensitive material of the detecting component 113 may be analyzed while the detecting component 113 is part of the band, strap, or other wearable. Alternatively or additionally, the detector 100 or at least the detecting component 113 may be separable from or releasably engaged with the band, strap, or wearable portion such that at least the detecting component 113 may be removed from the wearable portion to facilitate analyzing the analyte sensitive material of the detecting component 113.

The band, strap, or other wearable may be comprised of various layers or components in combination as described herein. In some cases, a layer of the detector 100 formed as a band, strap, or other wearable that includes the detecting component 113 may be formed with and/or utilize capillary pores or channels to draw sweat or sebum or other chemical substances from the target area of the subject wearing the band, strap, or other wearable and direct the analytes from the subject onto and/or into the detecting component 113.

The band, strap, or other wearable may include and/or may be formed of one or more suitable materials. For example, the band, strap, or other wearable may be formed from, among other suitable materials, an adsorbent material, a non-adsorbent material, an analyte sensitive material, hydrophobic material, gas permeable material, a woven material, gauze, polymers, metals, fabrics, paper, coatings, etc. In one example configuration of a detector 100 formed as or in the band, strap, or other wearable, the band, strap, or other wearable may be formed entirely or partially from a hydrophobic, gas permeable material and may include an analyte sensitive material.

Such bands, straps, or wearables including at the least the detecting component 113 of the detector 100 may include a gas permeable portion that facilitates analytes from the subject reaching the detecting component 113. Example materials for the gas permeable portions of the bands, straps, and/or wearables may include, but are not limited to, cotton, gauze, fabric, woven material, porated plastic, and/or other suitable gas permeable materials.

Further, the bands, straps, or wearables may be used and/or configured to stimulate analyte production from a subject's anatomy. Any suitable technique may be utilized for inducing analyte production including, but not limited to, the techniques discussed herein.

When configured as a band, strap, or other wearable, the detector 100 may have any suitable configuration and/or dimensions configured to be placed on or proximate to the target location (e.g., surface 126 of skin 124, a wound, etc.) of the subject over a short and/or an extended period of time for the purpose of detecting analytes emitted, excreted, secreted, emanated, or released from the target location. Example diameters or widths of the detecting component 113 of the band, strap, and/or other wearable may be less than or greater than 1 millimeter (mm). In some cases, the detecting component 113 incorporated in or in the form of a band, strap, or other wearable may have a diameter or width in a range from about 1 mm to about 10 centimeters (cm), a diameter or width in a range of about 1 mm to about 1 cm, or other suitable width or diameter, as desired. In one example of setting the diameter or width, a diameter or width of the detecting component 113 may be configured or set based on target area sizes and different diameters or widths of detecting components 113 may be utilized for different sizes of target locations so as to minimize or reduce the size of the detecting component 113 while maximizing detection of analytes from the target location over time, but this is not required. Other factors may be utilized and are contemplated for setting widths or diameters of the detecting component 113.

FIG. 9 depicts an illustrative detector configured as a wearable 900 (e.g., in band or strap form, as depicted) and positioned on the skin 124 of a subject's wrist or arm 903. Among other components, the wearable 900 may include the detecting component 113 (e.g., represented by broken lines) incorporated into a band or strap 917 configured to be worn around a subject's arm 903 or other suitable extremities. When the band or strap 917 is worn around the subject's arm 903, the detecting component 113 may be positioned at or adjacent to a target location (e.g., a skin surface, wound, wound dressing, etc. on the subject's arm 903) so as to be able to detect analytes from the target location. Although the wearable 900 is depicted with only the detecting component 113, the wearable 900 may include, among other components, the target facing component 111, the cover component 115, and/or a housing. Further, in some cases, the wearable 900 may be fixed at or adjacent the target location using the band or strap 917, but this is not required.

FIGS. 10-12 depict various views of the detector 100 in the form of a wearable. FIG. 10 depicts a top view of the detector 100 on a subject's arm or wrist 903. FIG. 11 depicts a cross sectional view of the detector 100 on the subject's wrist or arm 903, taken along line 11-11 in FIG. 10. FIG. 12 depicts a bottom view of the detector 100 depicted in FIG. 10.

The detector 100 depicted in FIG. 10 is positioned at or over a target location 1034 on the subject's wrist or arm 903. The detector 100 may be configured in a manner similar to the detectors discussed herein and may include the target facing component 111, the detecting component 113, and the cover component 115, where the target facing component 111 and the cover component 115 may define the space or opening 122. The detecting component may include dots of analyte sensitive material 128 applied to the substrate 130, which may be viewable through a transparent or clear material of the cover component 115.

As discussed in greater detail below, the dots and/or other configurations of the analyte sensitive material 128 of the detecting component 113 may be arranged in one or more desired patterns. Further, as discussed herein, the analyte sensitive material 128 may be viewed from a top of the substrate 130, a bottom of the substrate 130, or both from a top and a bottom of the substrate 130.

As depicted in FIG. 11, the detector 100 may be applied to the target location 134 on the subject's arm or wrist 903 and may include bands or straps 917 extending around the subject's arm or wrist 903 to secure the detector 100 at or adjacent the target location 134. The band or straps 917 may include two portions (e.g., as depicted in FIG. 11) and/or other suitable number of portions configured to secure the detector at or around subject's arm or wrist 903. In some cases, the band or straps 917 may include a single portion configured to extend from the detector 100, around the subject's anatomy, and back to the detector 100.

The band and/or straps 917 may include any suitable components/configurations configured to secure the detector 100 at the target location 1034 of the subject. When a plurality of bands and/or straps or portions thereof are utilized, the bands and/or straps 917 or portions thereof may engage one another (e.g., with a buckle, fasteners, hook-loop materials, tie connection, etc.) to grab the subject's arm or wrist 903 and/or otherwise secure the detector at the target location 1034. Alternatively or additionally, the bands and/or straps 917 may be configured with an elastic or resilient material to secure the detector 100 at the target location 1034.

The bottom view of the detector 100 depicted in FIG. 12 shows the band or straps 917 extending from outer sides of the target facing component 111. Although the band or straps 917 are depicted as extending from sides of the target facing component 111, the band or straps 917 may extend from other suitable portions of the detector 100 and/or encompass an entirety of the detector 100. Further, although the analyte sensitive material 128 depicted in FIG. 10 is not depicted in FIG. 12, in some cases, the analyte sensitive material 128 may be viewed from a top view, a bottom view, or both of the detecting component 113, as discussed herein.

As discussed herein, the analyte sensitive materials 128 of the detecting components 113 may be arranged or configured in one or more manners. For example, analyte sensitive material 128 may be arranged on the substrate 130 in a random manner and/or in one or more predetermined patterns. In some cases, the analyte sensitive materials may be selected and/or applied to the substrate 130 in a manner that facilitates identifying specific analytes. When the detector 100 includes such analyte sensitive materials 128, the detector 100 may be configured to detect a plurality of types of analytes, but this is not required. After exposure to analytes, the analyte sensitive materials may be analyzed by a machine (e.g., with a computer vision algorithm and/or other suitable techniques) and/or by human vision.

FIGS. 13A and 13B depict an example detecting component 113 of a detector 100 having numbers (e.g., one through twelve, as depicted in FIGS. 13A and 13B, or other suitable numbers) in a margin 1336 (e.g., a circular margin, which may be clock-like, as depicted in FIGS. 13A and 13B, a rectangular margin providing row and column numbers/identifiers, and/or other suitable configurations for identifying analyte sensitive materials) outside of and/or around various types of analyte sensitive material 128 applied to the substrate 130. Each line of dots from a center dot out to a number in the margin 1336 may be formulated from a different type of analyte sensitive material 128, where each type of analyte sensitive material may be configured to detect a different analyte from the subject's anatomy. A key may be provided to indicate which number is associated with which type of analyte (e.g., a type of analyte configured to detect a type of pathogen, bacteria, condition of the subject, etc.). In some cases, the length of the line from the center dot (e.g., a number of dots that react) may indicate a strength or quantity-present of the detected analyte, but this is not required.

FIG. 13A depicts the detecting component 113 prior to exposure to analyte from the subject's anatomy. FIG. 13B depicts the detecting component 113 after exposure to analyte from the subject's anatomy. As can be seen in FIG. 13B from the dots changing appearance between FIGS. 13A and 13B, a line of analyte sensitive material 128 extending from a center dot to a number six in the margin 1336 has reacted to analytes to which the detector 100 was exposed. Similarly, a line of analyte sensitive material 128 extending from the center dot to the number ten in the margin 1336 has reacted to analytes to which the detector 100 was exposed. As such, the detector 100 has detected two distinct analytes in the flow of analytes from the subject's anatomy and a key may be accessed and utilized to determine which analytes were detected.

As referred to, the detecting component 113 may indicate the strength or quantity of the detected analyte. For example, the center dot of the analyte sensitive material 128 may be configured to react to any or all analyte material (e.g., at least react to the different types of analytes the detector 100 is configured to detect) as an indication the detecting component 113 has been exposed to relevant analyte material. A change in a dot of a second ring of dots of the analyte sensitive material 128 (e.g., in the lines from the center dot to the number six and the number ten, as depicted in FIG. 13B) may indicate at least a first level of a type of analyte material for that line or ray of analyte sensitive material 128 was detected. A change in a dot of a third or outer ring of dots of the analyte sensitive material 128 (e.g., in the line from the center dot to the number six, as depicted in FIG. 13B) may indicate at least a second level of a type of analyte material for that row of analyte sensitive material 128 was detected. As such, FIG. 13B may indicate the detecting component 113 was exposed to at least a first level of an analyte indicative of a first pathogen, analyte, bacteria, and/or condition and at least a second level of an analyte indicative of a second pathogen, analyte, bacteria, and/or condition, where the first level is greater than the second level. Other suitable configurations are contemplated

In some cases, a portion of the detecting component 113 may be utilized as a control set or pattern of analyte sensitive material 128 that is configured to not react with analyte material to which the detecting component 113 is exposed. In such cases, the portion of the detecting component 113 that may be utilized as the control set of analyte sensitive material 128 may be compared to a portion of the analyte sensitive material 128 that is configured to react to the analyte material to which the detecting component 113 is exposed to confirm whether the reactive analyte sensitive material 128 does actually detect a particular type of analyte or otherwise react to the analyte material from the subject. The control portion of the analyte sensitive material 128 may be utilized by a human or computer vision algorithm to confirm and/or improve analysis of the exposed detecting component 113 as compared to an analysis without a control portion of the analyte sensitive material 128.

Further, the detecting component 113 may be configured with different arrangements of the analyte sensitive material 128, such as the row/column and clock-like configurations discussed above and/or other suitable configurations. For example, the analyte sensitive material(s) 128 may be configured on the detecting component 113 to form various desired patterns to indicate various parameter information concerning analyte exposed to the detecting component 113, as desired. For example, the analyte sensitive material may have different chemical configurations and/or may be applied in various quantities and/or patterns to indicate parameter information related to the analyte exposed to the detecting component 113. Example parameter information of the analyte exposed to the detecting component 113 may include, but is not limited to, analyte type detected, a number of different analyte types detected, analyte quantity, etc.

FIG. 14 depicts a detecting component 113 that may be configured to detect a predetermined analyte type indicative of a pathogen or condition of the subject that is to be detected using the detecting component 113. As depicted in FIG. 14, the detecting component 113 may provide an indication 1438 of the pathogen or condition of the subject to be detected. Although FIG. 14 includes the indication 1438 of the pathogen or condition (e.g., streptococcus) to be detected that is readable by a human prior to exposure to an analyte, the indication 1438 may only appear if the analyte is detected (e.g., the indication 1438 may be configured from an analyte sensitive material 128) and/or the indication 1438 may be encoded and configured to only be readable with a decoding system (e.g., a manual decoder, such as a mask or other suitable manual decoder, or a computerized or electronic decoder). Such encoded/decoding may be utilized for maintaining the privacy of the results of using a detector incorporating the detecting component 113. Further, the detecting component 113 may include the analyte sensitive material 128 applied to the substrate 130 to form a recognizable symbol 1440 that may be indicative of a positive test or otherwise indicative of detecting an analyte that was tested-for (e.g., a plus symbol, as depicted in FIG. 14, and/or other suitable symbol).

FIGS. 15 and 16 depict example configurations of detecting components 113 including the analyte sensitive material 128 applied to the substrate in an encoded format that is readable by computer vision algorithms (e.g., a quick response (QR) code as depicted in FIG. 15, a barcode as depicted in FIG. 16, other suitable one-dimensional or two-dimensional barcodes, and/or other suitable encoded patterns that are recognizable by hardware/software configured to detect the pattern) when the analyte sensitive material 128 reacts with an analyte to be detected. In one example, the analyte sensitive material 128 may be applied to the substrate 130 such that the analyte sensitive material 128 may change in color or other suitable appearance to a particular pattern when the analyte sensitive material 128 is exposed to an analyte the analyte sensitive material 128 was configured to detect.

FIGS. 17-19 depict a system that includes a detecting component 113 and a mask 1842. Although a generally rectangular configuration of the detecting component 113, the mask 1842, and features thereof is depicted in FIGS. 17-19, other shapes and/or orientations are contemplated.

FIG. 17 depicts a detecting component with a plurality of dots of analyte sensitive material 128 applied to the substrate 130 of the detecting component 113. Each dot of the analyte sensitive material 128 may be configured to react to particular types of analyte, such that when a particular type of analyte is present, the dots configured to detect that type of analyte form a pattern.

The mask 1842 may take on any suitable configuration. As depicted in FIG. 18, the mask may be a physical component that is analyte or pathogen/condition specific and includes a plurality of openings 1844 therethrough that form a pattern associated with the pathogen/condition, but this configuration is not required. Further, the mask 1842 may include an indication 1438 of the pathogen/condition to be detected (e.g., Pathogen A or other suitable pathogen) and information 1846 that may indicate how a reactive analyte sensitive material 128 that has reacted with the pathogen/condition associated with the pattern may look through the opening 1844 (e.g., “ALL RED”).

Masks having configurations in addition to or as an alternative to a particular set of openings, as depicted in FIG. 18, are contemplated. In one example, a mask may be or include a color decoding mask configured to be indicate certain colors at certain positions on the detecting component 113 indicate a pathogen/condition. In another example, the mask may be or include one or more filters that emphasizes a presence/absence of a specific wavelength or wavelengths of light reflected by the analyte sensitive material 128, where the presences/absence of a specific wavelength or wavelengths of light may indicate a pathogen/condition.

In some cases, the openings 1844 of the mask 1842 may include a color decoding feature, an optical filter, an optical magnifier, and/or other suitable feature that facilitates analyzing reactions of the analyte sensitive material 128. Further, adjacent each of the openings 1844, the mask 1842 may include color material that is the same as or similar to a color of the analyte sensitive material 128 prior to the analyte sensitive material reacting to a detected an analyte.

Further as depicted in FIGS. 18 and 19, the mask 1842 may, optionally, include one or more alignment features 1848 to facilitate aligning and/or registering the detecting component 113 with the mask 1842. When the mask 1842 includes alignment features, the detecting component 113 may be engaged with the alignment features 1848 and the dots of the detecting component 113 may align with the openings 1844 in the mask 1842. If the analyte sensitive material 128 of the dots that align with the mask 1842 appear as provided in the information 1846 (e.g., ALL RED), then it may be determined that the pathogen/condition (e.g., Pathogen A) associated with the mask 1842 was present in the analytes that were exposed to the detecting component 113.

In addition to or as an alternative to the physical mask 1842, numbers may be located on or next to the analyte sensitive material 128 of the detecting component 113. Then, a key may be provided that associates certain numbers (e.g., dots 1, 5, 6, and 9 when numbered left-to-right, top-to-bottom) associated with certain reactions of the analyte sensitive material 128 (e.g., the analyte sensitive material 128 turns red), where the certain numbers and certain reactions is indicative of a detected analyte, pathogen, bacteria and/or condition of the subject (e.g., Pathogen A). Other suitable keys and configurations of the detecting component are contemplated that may be analyzed and/or assessed by a human and/or computing device.

FIG. 20 depicts a detector 100 that includes a transparent cover component 115, a detecting component 113 in an opening 122, and a target facing component 111, which is configured similar to the detector 100 depicted in and discussed with respect to FIG. 5, while also including tubing 2050. The tubing 2050 may be in communication with one or more pumps and may facilitate applying a flow of fluid to the opening 122 and a target location on the subject's anatomy and/or removing a flow of fluid from the opening 122 and the target location on the subject's anatomy. The fluid maybe provided to and/or removed from opening 122 once the detector 100 is applied to the target location to facilitate applying a turbulent flow to and/or above the target location for inducing analyte production and/or interaction with the detecting component 113. Further, although not required, analyte from the target location may be removed from the opening 122 and collected for analysis at a location spaced from the detector 100 and/or the removed analyte may be pumped back into the opening 122 for interacting with the detecting component 113. Applying and/or removing fluid from the opening 122 may be configured to concentrate analytes from the target location at and/or around to the detecting component 113 to facilitate detection of the analyte.

The tubing 2050 may including any suitable number of tubing components and/or any suitable configuration of the tubing 2050 to facilitate detecting analytes. As depicted in FIG. 20, the tubing 2050 may include an inlet tubing 2050a configured to provide a flow of fluid to the opening 122 and an outlet tubing 2050b configured to remove a flow of fluid from the opening 122. Each of the inlet tubing 2050a and outlet tubing 2050b may be connected to separate pumps (e.g., an inlet pump and an outlet pump) or the inlet tubing 2050a and the outlet tubing 2050b may be connected to a single pump that is capable of creating a positive pressure in the opening 122 through the inlet tubing 2050a and a negative pressure in the opening 122 through the outlet tubing 2050b.

In some cases, the outlet tubing 2050b and/or other tubing 2050 extending within the opening 122 (e.g., the inlet tubing 2050b and/or other suitable tubing when it extends into the opening 122) may include holes or openings to form a manifold along a length or a portion of a length of the outlet tubing 2050b. Such a configured tubing 2050 may be utilized to provide localized pressure and/or turbulence to agitate and/or stimulate movement of analytes from subject's anatomy toward the detector 113.

Further, tubing 2050 and the opening 122 may create a closed loop system in which the fluid is pulled from the opening 122 through the outlet tubing 2050b and provided back to the opening 122 through the inlet tubing 2050a. Alternatively, the tubing 2050 and the opening 122 may be an open loop system where fluid is provided to the opening 122 from an ambient source or other suitable sours, which may or may not include fluid from the opening 122.

In some cases, the fluid flow from the outlet tubing 2050b may be provided to a remote detector (e.g., a detector spaced from the detector 100 from which fluid is removed through the outlet tubing 2050b) or storage container for later analysis. In one example use of a detector 100 including the tubing 2050, fluid may be provided to the opening 122 through the inlet tubing 2050a and circulated in the opening 122 therein for a desired or sufficient period of time to gather analytes at the detecting component 113 and/or otherwise to accurately assess and/or analyze the analytes from the target location on the subject.

Fluid circulation through the tubing 2050 and the opening 122 may be performed with a uniform flow rate and/or it may be performed with non-uniform flow rates (e.g., a pulsing flow rate or other suitable non-uniform flow rate) to induce turbulence and mixing of analytes within the opening 122. Further, the flow rate may be a relatively high flow rate (e.g., of or about 300 cm³/min), a relatively low flow rate (e.g., of or about 4 cm³/min), and/or values therebetween, which may be fixed prior to creating the flow and/or adjustable during the flow (e.g., automatically and/or manually adjustable based on a sensed parameter (e.g., temperature, humidity, quantity of analytes, detection of analytes, etc.) and/or other suitable factors). Example flow rates may be less than 40 cm³/min, greater than 600 cm³/min, and/or in a range of or about 40 cm³/min to 600 cm³/min. In another example, the flow rates may be in a range of or about 4 cm³/min to 300 cm³/min.

As depicted in FIG. 20, the tubing 2050 may enter into the opening 122 through a side of the detector 100, however, other suitable configurations are contemplated. The inlet tubing 2050a may terminate at one end of the opening 122 and the outlet tubing 2050b may terminate at a second end of the opening 122, which may facilitate the flow of fluid interacting with analytes from the target location.

FIG. 21 depicts a side view of the detector 100 depicted in FIG. 20, taken from a side opposite the side at which the tubing 2050 may enter the detector 100. As represented in FIG. 21, the tubing 2050 may enter the detector 100 and the opening 122 through the target facing component 111, but other suitable configurations are contemplated.

FIG. 22 depicts a cross-sectional view of a detector 100 similar to the view of the detector 100 in FIG. 8 that includes supports 132. When the tubing 2050 is included with the detector 100 and fluid is actively moved within the opening 122, the supports 132 may facilitate supporting a flexible cover component 115 and a detecting component 113 at a location (e.g., a consistent location) spaced from the target location on the subject.

Although FIGS. 20-22 depict configurations of the detector 100 that include the tubing 2050 for use in inducing fluid flow in the opening 122, pressures and/or fluid flow in the opening 122 may be applied or changed in one or more other suitable manners. In one example, when the target facing component 111, the detecting component 113, and/or the cover component 115 is flexible, a user may be able to manually flex or push one or more components of the detector 100 to induce a fluid flow and/or change pressure in the opening 122. In a further example, the detector 100 may include a one-way valve that allows fluid to leave the opening 122 and does not allow fluid to enter the opening 122. When the detector 100 is secured around the target location of the subject and the detector 100 is flexible and resilient, a user may create a negative pressure in the opening 122 by applying a force to the cover component 115 or other suitable portion of the detector 100 to cause the detector 100 to flex and then removing the force to allow the detector 100 to return to its previous shape and draw analyte from the target location as it returns to its previous shape. In some cases, the detector 100 may include one or more valves to facilitate adjusting pressures in the opening 122. Other suitable configurations are contemplated for creating flows and/or changes of pressure in the opening 122.

FIG. 23 depicts a schematic diagram including a cross-sectional view of an illustrative configuration of a detector 2300 configured to facilitate use of a flow of fluid to detect analytes from the skin 124 of the subject. The detector 2300 may be similar to the detector 100 described above, where a target facing component 2311 may be a conduit component 2360 configured to direct the fluid flow to a target location (e.g., the subject's skin 124, a wound, etc.) and to a detecting component 2313. The detector 2300 may further include a cover component 2315. FIG. 24 depicts a bottom view of the detector 2300 depicted in FIG. 23. Although not depicted in FIG. 23, a pump system may be part of or coupled to the detector 2300.

The detector 2300 depicted in FIG. 23 may be placed directly on the surface of a target location (e.g., the surface 126 of the skin 124 of the subject) or could be held above (e.g., proximal of) the surface. In some cases, allowing for a space between at least a portion of the bottom surface 2320 of the detector 2300 and the target location of or on a subject may facilitate detecting analytes and maintaining cleanliness and/or sanitation of the detector 2300. When a space between at least a portion of the bottom surface 2320 of the detector 2300 and the surface 126 is desired, the bottom surface 2320 of the detector 2300 may be held by a user or a mechanical support at a location spaced from the surface of the target location, a disposable or reusable component may extend between the bottom surface 2320 of the detector 2300 and the surface of the target location as a standoff (e.g., the standoff may be the conduit component 2360 or may be a component that is used in addition to the conduit component 2360), the detector 2300 may be part of or placed in a wound dressing of a subject that spaces the bottom surface 2320 of the detector 2300 from the surface 126, and/or other suitable configuration may be used.

In some cases and similar to as discussed above, the detector 2300 may facilitate providing a fluid flow at positive pressure, represented by arrows P, to the surface of the target location (e.g., the surface 126 of the skin 124 of the subject, as depicted in FIG. 4) and applying a flow of fluid at a negative pressure, represented by arrows N, at a location interior of the location at which positive pressure is applied to draw the flow of fluid and analytes (e.g., as represented by arrows 2366) from or from proximate to the surface of the target location to the detecting component 2313. Further, the detector 2300 may include the conduit component 2360 having a vacuum port or channel 2362 for directing the negative pressure fluid flow toward the detecting component 2313 and a supply port or channel 2364 for directing the positive pressure fluid flow toward the target location.

Arrows R represent a return of the flow of fluid to the detector 2300 (e.g., from a pump) and arrows T represent a transition of the flow of fluid through the detector 400 from positive pressure to negative pressure. In operation, as the fluid flow transitions from being under positive pressure to negative pressure, the analytes may be added to and/or mixed with the fluid flow and directed toward the detecting component 2313. Other configurations, however, are contemplated and the negative pressure fluid flow and the positive pressure fluid flow may be located at one or more other suitable locations or positions relative to one another. Further, the negative pressure fluid flow and the positive pressure fluid flow may be dependent on one another or may be independent of one another.

The conduit component 2360 may be made of any suitable material and may have any suitable configuration. In some cases, the conduit component 2360 may be formed from material similar to and/or configured similar to the material and/or configuration of the target facing components and/or the cover components, discussed herein. In one example, the conduit component 2360 may be configured from conformable foam.

As depicted in FIG. 24, the conduit component 2360 may be formed from two concentric rings, but other designs and configurations are contemplated. The rings forming the conduit component 2360 may be fixed relative to one another via other layers of the detector 2300 and/or directly connected to one another. Although the detector 2300 may have other configurations, an inner circumference of the outer ring and an outer circumference of the inner ring may define the supply channel 2364 for receiving a fluid flow at a positive pressure and an inner circumference of the inner ring may define the vacuum channel 2362 for receiving a fluid flow at a negative pressure, where the supply channel 2364 and the vacuum channel 2362 may extend from the bottom surface 2320 to the detecting component 2313.

FIG. 25 depicts a schematic illustrative configuration of the detector 2300 including or otherwise in communication with a pump 2570, where the detecting component 2313 may be in contact with and/or coupled to the proximal end of the conduit component 2360, which is shown from a side view. Although only one pump 2570 is depicted in FIG. 6, it is contemplated that the detector 2300 may utilize two or more pumps 2570. In one example, a first pump may be for pumping a fluid flow into the detector 2300 (e.g., at a positive pressure) and a second pump may be for pumping fluid flow out of the detector 2300 (e.g., at a negative pressure), but this is not required.

The pump 2570 may be any suitable type of pump. For the example, the pump 2570 may be a vacuum pump, a manually operated vacuum pump, an electric powered vacuum pump, a pneumatically powered vacuum pump, an oscillating pump, a plenum, a pump in communication with a plenum, and/or any suitable device configured to create negative pressure, positive pressure, or both negative and positive pressure to draw a fluid flow through or over the detecting component 2313. In some configurations, the pump 2570 may be configured such that the fluid inlet and the fluid outlet may induce a fluid flow vortex to create turbulent flow and to more efficiently gather analyte and direct the analyte to the detecting component 2313.

To increase efficiency of harvesting and detecting analytes from the surface of a target location (e.g., a skin surface of a subject, a wound of or on a subject, etc.), it may be advantageous to isolate the fluid flow in and out of the detector 2300 such that it creates an oscillating movement of fluid flow over the surface of the target location. In some cases, the oscillating movement of the fluid flow over the surface of the target location may produce a temporary vacuum seal of the detector 2300 against anatomy of the subject to draw sweat and/or other suitable excretions from the subject to increase analyte material to which the detector 2300 may be exposed.

In one illustrative configuration, an oscillating airflow pump may be utilized. In one example, the oscillating airflow pump may have an oscillation range between approximately 0.1 Hz to approximately 1000 Hz to create oscillating movement of fluid flow over the surface of the target location. In another example, the oscillating airflow pump may be configured to create oscillating movement of fluid flow over the surface of the target location at an oscillation of about 4 Hz to about 7 Hz. The pressure induced by the oscillating pump could be mild or strong, ranging between approximately 0.001 atmospheres to 10 or more atmospheres. Other suitable configurations of the oscillating airflow pump are contemplated to improve an efficiency of detecting from around a surface of a target locations.

Although FIG. 25 depicts the pump 2570 in communication with the fluid flow through the vacuum channel 2362, the pump 2570 may not receive an output from the vacuum channel 2362. Instead, the pump 2570 may be configured to evacuate a plenum. After such evacuation, the plenum may be sealed with a manual or automatic valve. The manual or automatic valve may then be used as the supply of vacuum to be applied through the vacuum channel 2362. During evacuation, the fluid flow mixed with analytes may be passed through or along the detecting component 2313 to detect analytes from the subject. Alternatively or additionally, the mixture of fluid flow and analytes may be stored within the plenum for later analysis.

FIG. 26 depicts a schematic illustrative configuration of the detector 2600 including or otherwise in communication with a pump 2570 similar to as in FIG. 25, where a detecting component 2613 is in contact with and/or coupled to a distal end of a conduit component 2660 (e.g., the detecting component 2613 may be positioned between the conduit component 2660 and a target facing component 2611). The conduit component 2660 may be similar to the conduit component 2360, where the conduit component 2660 may be considered a cover component 2615 of the detector 2600 and may include a vacuum port or channel 2662 and/or a supply port or channel 2664.

FIG. 27 depicts a schematic view of an illustrative configuration of a detector 2700. The detector 2700 depicted in FIG. 27 may include a base 2772 (e.g., a target facing component 111 and/or other suitable base) and a cover 2774 (e.g., a cover component 115 and/or other suitable cover). Although not depicted, the cover 2774 and/or the base 2772 may be transparent such that analyte sensitive material may be viewable through the cover 2774 and/or the base 2772.

Although not required in all configurations, the detector 2700 may include a vacuum port 2776 formed from or otherwise extending from the cover 2774. The vacuum port 2776 may define a vacuum channel 2762 configured for fluid communication with a pump, but this is not required.

The detector 2700 may take on any suitable shape or configuration. For example, the detector 2700 may have a circular profile (e.g., as depicted in FIG. 27), a rectangular profile, a square profile, an amorphous profile (e.g., in response to be flexible and/or pliable), and/or one or more other suitable profiles.

FIG. 28 depicts a cross-sectional view taken along line 28-28 of the illustrative configuration of the detector 2700 depicted in FIG. 27. As depicted in FIG. 28, the detector 2700 may include the base 2772, the cover 2774, and a detecting layer 2775 (e.g., a detecting component 113 and/or other suitable detecting layer). In some cases, the detecting layer 2775 may be positioned between the cover 2774 and the base 2772, such that a fluid flow of analytes may be forced through or otherwise move through or along the base 2772 and the detecting layer 2775 prior to exiting the detector 2700 through the vacuum channel 2762 and the vacuum port 2776. In some cases, the fluid flow of analytes directed or focused over or through a small area (e.g., an area less than an entire area) of the detecting layer 2775 (e.g., one or more locations of analyte sensitive material) to concentrate the analytes as the analytes contact the detecting layer 2775.

The detecting layer 2775, the base 2772, and the cover 2774 may be formed from any suitable materials and may have any suitable configuration. In some cases, one or both of the base 2772 and the cover 2774 may be entirely or at least partially formed from elastomeric and/or flexible materials to provide compliance when placed with pressure into contact with the surface (e.g., the surface 126 or other suitable surface) of or adjacent to the target location (e.g., the skin 124, wound, or other suitable target location) of the subject, but this is not required and one or both of the base 2772 and the cover 2774 may be made from rigid materials such as plastics, polycarbonates, polypropylene, polyethylene, ABS, and/or the like. In one example, the detecting layer 2775, the base 2772 and the cover 2774 may be formed of similar materials and in similar configurations as the detecting components, the target facing components, and the cover components, respectively, discussed herein, but this is not required and one or more of the detecting layer 2775, base 2772, and the cover 2774 may take on one or more other suitable configurations.

Although the detector 2700 is depicted as including a single detecting layer 2775, two or more detecting layers 2775 may be utilized. For example, two detecting layers 2775 may be positioned in contact with one another or may be spaced apart from one another by spacers or other suitable components of the detector 2700. In some cases, the two detecting layers 2775 may be positioned so as to partially overlap one another, entirely overlap one another, or be spaced such that there is no overlap between the two detecting layers 2775. As discussed above, when two or more detecting layers 2775 are utilized, one or more may be configured to a particular type of analyte and/or one may be a control detecting layer 2775 configured to be compared to a reacting detecting layer 2775. When included, the control detecting layer 2775 may have a same or similar layout (e.g., analyte sensitive material layout) as the reacting detecting layer 2775, but the control detecting layer 2775 may be configured so as to not react to exposure to analytes and the reacting detecting layer 2775 may be configured to react when exposed to the analytes.

FIG. 29 depicts a schematic exploded view of the detector 2700 depicted in FIG. 27. The detecting layer 2775 is depicted in FIG. 29 as having a disc-like form, but other configurations are contemplated.

As depicted in FIG. 29, the detector 2700 may be assembled by placing the detecting layer 2775 into the base 2772 and the cover 2774 may be placed over the detecting layer 2775. In some cases, a friction fit, a snap connection, and/or other suitable connection may be made between the base 2772 and the cover 2774 to assemble the detector 2700. The components of the detector 2700 may be separated (e.g., to remove the detecting layer 2775 for analysis, to sanitize the detector 2700, etc.) by separating the cover 2774 from the base 2742 and removing the detecting layer 2775 from the base 2772. Alternatively, the components of the detector 2700 may be sealed such that the components of the detector 2700 may not be separated without destroying the detector 2700.

The detecting layer 2775 may be or include a substrate 2730 similar to the other substrates discussed herein. Further, as depicted in FIG. 29, dots of analyte sensitive material 2728 have been applied to the substrate 2730. Although the dots are provided in rows and columns, other configurations are contemplated as discussed herein and/or otherwise.

Once the detecting layer 2775 has been exposed to a desired amount of analyte, the detecting layer 2775 may be separated from other components of the detector 2700 and analyzed. Alternatively or additionally, an entirety of or additional portions of the detector 2700 may be analyzed.

As depicted in FIG. 29, the base 2772 may include one or more ridges 2778 facing the detecting layer 2775. In some cases, the ridges 2778 in the base 2772 may be configured to position or maintain the detecting layer 2775 above a surface of the base 2772 defining openings 2780 in the base 2772 to allow fluid flow through the openings 2780, between the base 2772 defining the openings 2780, and through or along the detecting layer 2775. As such, upon creation of a negative pressure with a pump (e.g., the pump 2570 or other suitable pump), a fluid flow with analytes may be drawn through the base 2772, via the openings 2780, and through and/or around the detecting layer 2775. As the fluid flow passes through or along the detecting layer 2775, analytes may react with the detecting layer 2775 for analysis and the fluid flow may pass into contact with the cover 2774 and out through the vacuum port 2776.

Although the ridges 2778 are depicted in FIG. 29 as elongated raised surfaces being circumferentially equally spaced and extending radially outward from a center portion of the base 2772 to a portion of the base 2772 near an outer circumference, the ridges 2778 may take on any suitable configuration to create a space between the base 2772 and the detecting layer 2775 that facilitates fluid flow through the openings 2780, between the base 2772 defining the openings 2780, and through and/or around the detecting layer 2775. Example ridge 2778 configurations include, but are not limited to, elongated raised surfaces, continuous raised surfaces, non-continuous raised surfaces, grid-like raised surfaces, concentric circle raised surfaces, depressed surfaces, etc. Additionally or alternatively, ridges 2778 may extend from the detecting layer 2775 and/or may be formed from a component separate from the base 2772 and the layer 2775. In some cases, the ridges 2778 may be omitted.

Although the openings 2780 are depicted in FIG. 29 as being circumferentially equally spaced and having a triangular shape extending radially inward toward the center portion of the base 2772 from a portion of the base 2772 near the outer circumference, the openings 2780 may take on any suitable configuration to create an opening between a bottom surface 2720 of the base 2772 and an interior surface 2790 of the base 2772 that facilitates fluid flow through the base 2772. Example configurations for the openings 2780 include, but are not limited to, configurations with triangular profiles, circular profiles, elongated profiles, rectangular profiles, oval profiles, square profiles, etc.

FIG. 30 depicts a bottom perspective view of the base 2772. In addition to the openings 2780, the base 2772 may be configured to define or otherwise include one or more notches 2792. The notches 2792 may be configured to allow ambient airflow to be drawn through the base 2772 and into a space 2794 underneath the bottom surface 2720 of the base 2772 that is in fluid communication with the openings 2780. Further, the notches 2792 may facilitate preventing the surface of the target location or liquid (e.g., sweat and/or other liquids) from being drawn into and/or around the detecting layer 2775.

In some cases, utilizing the notches 2792 in the base 2772 may mitigate a need to provide a fluid flow at a positive pressure to an area proximate the surface (e.g., the surface 126 or other suitable surface) of the target location (e.g., the skin 124, a wound, a wound dressing, or other suitable target location) of or on the subject (e.g., the fluid flow supply from the pump may be omitted, as desired). For example, in operation of the detector 2700, the base 2772 may be placed on or adjacent the target location of the subject, and a negative pressure fluid flow may be created by a pump connected to or otherwise in fluid communication with the detector 2700 that draws fluid through the notches 2792, into the space 2794 adjacent the target location and allows the fluid flow to mix with analytes, then draws the mixed fluid flow through the openings 2780 into contact with the detecting layer 2775 to detect the analytes in the fluid flow, after which the fluid flow may exit the detector 2700 through the cover 2774. Other operational configurations are contemplated.

FIG. 31 is a bottom perspective view of the cover 2774. As depicted in FIG. 31, the cover 2774 may include one or more ridges 2796 facing the detecting layer 2775. In some cases, the ridges 2796 in the cover 2774 may be configured to maintain, position, or orient the detecting layer 2775 below an interior or bottom surface 2798 of the cover 2774 defining an opening 2718 that may lead to the vacuum channel 2762 defined by the vacuum port 2776. Such a configuration of the ridges 2796 may allow for the negative pressure fluid flow to pass through or around the detecting layer 2775, through a space between the detecting layer 2775 and the cover 2774 that may be at least partially defined by the ridges 2796 contacting the detecting layer 2775, and exit the detector 2700 through the vacuum port 2776.

Although the ridges 2796 are depicted in FIG. 31 as elongated raised surfaces being circumferentially equally spaced and extending radially outward from a center portion of the cover 2774 to a portion of the cover 2774 near an outer circumference, the ridges 2796 may take on any suitable configuration to maintain, position, or orient the detecting layer 2775 relative to the cover 2774 and the opening 2718. Example configurations of the ridges 2796 include, but are not limited to, elongated raised surfaces, continuous raised surfaces, non-continuous raised surfaces, grid-like raised surfaces, concentric circle raised surfaces, etc. Additionally or alternatively, ridges 2796 may extend from the detecting layer 2775 and/or may be formed from a component separate from the cover 2774 and the layer 2775. In some cases, the ridges 2796 may be omitted.

FIG. 32 is a schematic perspective view of the detector 2700 including or otherwise coupled (e.g., hermetically coupled or coupled in one or more other suitable manners) to a pump 2570 via the vacuum port 2776. As depicted in FIG. 32, the pump 2570 may be a hand activated pump to manually control vacuum pressure to the detector 2700 in order to allow negative pressure to draw analyte through the detector 2700, but this is not required and the pump may be any other suitable pump discussed herein or otherwise.

Among other components, the pump 2570 may include a vacuum bulb 2781, a fluid inlet 2784, and a fluid outlet 2782. In some cases, the fluid inlet 2784 and/or the fluid outlet 2782 may be or may include one-way valves to facilitate one-way directional flow through the pump 2570 (e.g., fluid may flow in through the fluid inlet 2784 and fluid may flow out through the fluid outlet 2782). In operation, a user may manually squeeze the vacuum bulb 2781 to push fluid out of the fluid outlet and release the vacuum bulb 2781 to draw fluid into the pump 2570 through the fluid inlet 2784, such that fluid may be drawn into the detector 2700, pass through or around the detector 2700, as described herein, pass into the pump 2570 through the fluid inlet 2784, and move out of the pump 2570 through the fluid outlet 2782. Other suitable manual and/or automated pump configurations are contemplated.

The vacuum bulb 2781 may formed from any suitable material. Example materials include, but are not limited to, elastomeric materials, rubber, silicone, and/or other suitable medical grade materials.

The fluid inlet 2784 and/or the fluid outlet 2782 may be formed from any suitable materials and have any suitable configuration that may be the same, similar, or different than a configuration of the other of the fluid inlet 2784 and the fluid outlet 2782. Example materials for forming the fluid inlet 2784 and/or the fluid outlet 2782 include, but are not limited to, plastics, metals, ceramics, and/or other suitable materials. In one example configuration of the fluid inlet 2784 and the fluid outlet 2782, each may have a port or nipple to facilitate fastening and/or connecting directly to the vacuum port 2776 of the detector 2700 and/or tubing defining a flow channel.

In the configuration of FIG. 32, analytes may be drawn into reactive contact with the analyte sensitive material 2728 of the detector 2700 in response to a vacuum pressure applied by the pump 2570. Although not required, fluid pumped out of the detector 2700 by the pump 2570 may be pumped back into headspace above a target location of the subject (e.g., above skin, a wound, a wound dressing, etc.) to circulate analyte fluid through the detector 2700 and concentrate analyte material.

FIG. 33 depicts a schematic top perspective view of an illustrative configuration of a detector 3300. As depicted in FIG. 33, the detector 3300 may include a base 3372 (e.g., a target facing component 111 and/or other suitable base) and a cover 3374 (e.g., a cover component 115 and/or other suitable cover) defining a vacuum port 3376 and a vacuum channel 3362. In some cases, the vacuum port 3376 may be configured to engage a fluid inlet 3384 of the pump 2570 similar to as depicted in FIG. 32, but this is not required.

FIG. 34 depicts a schematic exploded bottom perspective view of the configuration of the detector 3300 depicted in FIG. 33. In addition to the base 3372 and the cover 3374, the detector 3300 depicted in FIG. 34 may include a detecting tube 3391 (e.g., a detecting component 113 and/or other suitable detecting tube) and an end cap 3393, but this is not required. The detecting tube 3391 may include or may be a substrate 3330 and analyte sensitive material 3328 may be applied thereto in a manner that the applied analyte sensitive material 3328 interacts with and reacts to analyte from a subject. In operation, the detector 3300 depicted in FIGS. 33 and 34 may operate in a similar manner to the other configurations of detectors described herein and/or in one or more other suitable manners.

The detecting tube 3391 may be fabricated by applying (e.g., printing and/or applying in one or more other suitable manners) the analyte sensitive material 3328 onto a substantially rectangular substrate 3330. Once the analyte sensitive materials 3328 has been applied to the substrate 3330, the substrate 3330 may be rolled into a tube shape prior to assembly into the cover 3374.

The cover 3374 may include a tube support 3388. The tube support 3388 may be configured to support or otherwise provide stability to the detecting tube 3391 when the detector 3300 is fully assembled. In some cases, the tube support 3388 may include one or more openings or slots 3386 that may be positioned to allow a fluid flow to pass therethrough to or from the detecting tube 3391 and out of the detector 3300 through the vacuum channel 3362.

The detecting tube 3391 may be configured to detect and react to analytes from a subject. As such, the detecting tube 3391 may be configured from similar materials as the materials used to form the detecting components 113 described herein and/or other suitable materials. Further, although the detecting tube 3391 is described as a tube, the detecting tube 3391 may be considered a layer and/or take on one or more other suitable shapes or other configurations.

The end cap 3393 may be configured to be secured to the tube support 3388. For example, the end cap 3393 may be secured to the tube support 3388 using a snap connection, a luer lock connection, a threaded connection, and/or one or more other suitable types of connections. In one example, when the cover 3374 is in contact with the base 3372, the tube support 3388 may extend through the detecting tube 3391 and the end cap 3393 may extend through the base 3372 such that the tube support 3388 and the end cap 3393 engage one another with a snap connection to couple the components of the detector 3300 to one another. Although the end cap 3393 is described as a component separate from the base 3372, the end cap 3393 and/or the function of the end cap 3393 may be incorporated into the base 3372.

The end cap 3393 may be formed from any suitable material. In some cases, the end cap 3393 may be formed from a similar or different material than the base 3372 and/or the cover 3374. In some cases, the end cap 3393 may be made of a suitable elastomeric material, a rigid material, and/or other suitable materials. In one example, a portion 3393a of the end cap 3393 configured to engage the tube support 3388 may be formed from a substantially rigid material and a portion 3393b of the end cap 3393 configured to engage the base 3372 may be formed from an elastomeric material, but this is not required.

In addition to the notches 3352, the base 3372 may include one or more openings 3380 extending thorough the bottom surface 3320 of the base 3372. When the detector 3300 is assembled, the openings 3380 may create a flow path for a fluid flow that extends from a space defined by the base 3372 and the target location of or on the subject (e.g., the skin 124, a wound, etc.), through the openings 3380 and into a space defined by an exterior surface of the detecting tube 3391 and an inner surface of the cover 3374. Once the fluid flow is in the space between the cover 3374 and the detecting tube 3391, the fluid flow may be suctioned through or along the detecting tube 3391, through the slots 3386 in the tube support 3388, and out of the vacuum channel 3362. In another example flow path, the openings 3380 may be configured in the base 3372 and relative to the cover 3374 such that the flow path extends through the openings 3380 and into a space defined by an interior circumference of the detecting tube 3391, through the detecting tube 3391 to the space between the detecting tube 3391 and the cover 3374, and out of the detector 3300, where the vacuum channel 3362 is configured in the cover 3374 to evacuate the fluid flow from the space between the detecting tube 3391 and the cover 3374. Other suitable configurations are contemplated.

The detectors 100, 900, 2300, 2600, 2700, 3300, and/or the components thereof described herein may be manufactured by any suitable techniques. In some cases, the detector and/or the components thereof may be manufactured by techniques to optimize desired properties including, but not limited to, adhesiveness, flexibility, porosity, non-porosity, adsorbent properties, compatibility with adjacent layers, tear-resistance, tensile strength, durability, shear strength (between components), and/or other suitable properties. In one example, advanced three-dimensional printing or deposition techniques may allow for customized properties for each component or layer, such that the components or layers may take on a uniform or predetermined composition or a gradient composition or a matrix composition depending on the property for and within a component, as desired. Such techniques and considerations may be utilized when considering the overall desired properties of the detector, including, but not limited to, the mechanical properties, cost, usability, manufacturability, durability, biocompatibility, etc. of detector.

The detectors 100, 900, 2300, 2600, 2700, 3300 described herein may be utilized in one or more methods of detecting analytes from the target location of a subject. In one example, a method 3500 of using a detector for detecting analytes (e.g., VOCs and/or other chemical substances) emitted, excreted, and/or secreted from a target location (e.g., skin, a wound, etc.) of or on a subject is provided, as depicted in FIG. 35an.

The method 3500 may include cleaning or otherwise preparing 3502 a target location surface of the subject for use with the detector (e.g., where the detector is in contact with or spaced from the surface of the subject from which analytes are to be detected). Cleaning or otherwise preparing the target location surface for use with the detector may include alcohol-swabbing the target location surface, washing the target location surface, applying a sweat inducer to the target locations, and/or cleaning or preparing the target location surface in one or more other suitable manners.

Further, before, while, or after preparing the target location surface, the detector may be removed from a sterilized packaging in which the detector may be transported and/or stored. If the detector includes a seal or a release liner to protect adhesive on the detector and/or to protect the detecting component, the seal or release liner may be removed (e.g., removed from the target facing component and/or other suitable component of the detector).

Further, the method 3500 may include positioning 3504 the detector at a desired location relative to the prepared surface of the target location of or on the subject (e.g., on, or adjacent to and spaced from, the wound and/or skin surface of the subject that has been prepared for use with the detector) and exposing a detecting component of the detector to analytes from the target location. In some cases, the detector may be positioned at a location that will facilitate receiving analytes at or through the detector. To facilitate positioning the detector, the detector may be affixed at a desired location, may be held at a desired location by a person, may be held at a desired location by a support, may be held at a desired location by a band or strap, and/or secured at a desired position in one or more other suitable manners.

When the detector includes an adhesive backing or is otherwise configured to be used with adhesive, the adhesive may be exposed to the surface at or adjacent to the target location of or on the subject and/or a standoff positioned adjacent to the target location to secure the detector at the desired position. When applying the detector to the skin surface at a desired location, an adequate level of pressure may be applied to the detector to create a seal between a bottom side of the detector and the skin surface.

Although not required, after the detector has been positioned at a desired location relative to the prepared surface of the target location, a pump may be utilized to facilitate detection of analytes from the subject. When using the detector with a pump, negative pressure and/or a positive pressure may be applied to the detector. For example, a pump may be connected to a vacuum port of the detector and a negative pressure may be applied across a detecting component. In some cases, the negative pressure may be applied at a level and for a period of time to allow a suitable amount of analytes to emit, excrete, and/or secrete from the target location, be drawn through or around the detecting component, and be detected by the detecting component of the detector.

In some cases, the detector may create a seal or partial seal with the subject's anatomy to contain analyte from the subject within the detector for passive (or active) detection. After a sufficient amount of time, while still sealed to the anatomy of the subject or after being removed from the anatomy of the subject, the analyte sensitive material of the detecting component of the detector may be analyzed 3506 via human vision, computer vision, and/or other suitable techniques. Example techniques for analyzing analyte sensitive material are discussed herein and additional or alternative techniques are known in the art. In one example, analyte sensitive material that has been exposed to analytes may be compared to a key that provides a connection between analyte sensitive material reactions to detected analyte and analyte(s), pathogens, bacteria, and/or conditions to determine which analyte(s), pathogens, bacteria, and/or conditions have been detected.

Further, the detector may be removed from the desired location relative to the prepared surface. In one example, after a desired amount of time detecting analytes and a suitable amount of analytes have been detected such that the analyte sensitive material may be analyzed, the detector may be removed from the desired location.

An amount of time the detector is at the desired location detecting analytes may depend on one or more parameters. Example parameters include, but are not limited to, a type of analyte targeted, properties of interest from analyses of detected analytes, an amount of negative pressure applied to the detector, a temperature at the desired location, a pressure on a surface of the desired location, and/or other suitable parameters.

Once the detector has been removed from the desired location, the detector or at least a detecting component of the detector may be analyzed and/or transported for analysis. In some cases, the detecting component of the detector may be removed from the detector after exposure to analytes and detecting analytes, packaged in a tamper-proof package, and sent to a lab for a detailed analysis of the detected analytes.

This method 3500 and/or other methods of use may be performed entirely or partially by one or more of the subject whose analytes are being detected and/or another person, such as a health care provider (e.g., medical doctor, nurse practitioner, physician's assistant), technician, or other suitable person. The methods may also be entirely or partially robotically performed or assisted by a machine or computing device. Such machine-assisted techniques may improve analyte detection outcomes through more consistent application of pressure to create the desired seal between the detector and the surface of or adjacent the target location, through consistent reading of the results of analyte detection, and/or through other suitable techniques.

The various methods of using the detector 100, 900, 2300, 2600, 2700, 3300 described herein to detect analytes may be augmented or supplemented by increasing analyte emittance, excretion, and/or secretion by the body of the subject whose analytes are being detected. Because it is known that target analytes can reside in sweat, analyte emittance, excretion, and/or secretion may be increased by stimulating sweat glands to increase sweat production. One way to induce or otherwise increase sweat by the subject may be to heat all or portions of detector 100, 900, 2300, 2600, 2700, 3300, particularly portions in contact with the skin surface. Another option for inducing a subject to sweat is by applying chemical agents (e.g., gaseous and/or liquid chemical agents), for example carbachol and pilocarpine, to the skin surface.

In some configurations, the detector 100, 900, 2300, 2600, 2700, 3300 may include or may be used with one or more electrodes that are to be applied to the skin of the subject as part of or an accompaniment to the detector 100, 900, 2300, 2600, 2700, 3300 to create a voltage gradient, for instance at the microampere level of current, not only to create heat but also generate a vibrational element through the subject's skin. Such use of electrodes may drive sweat stimulating agents more effectively through skin. A similar process could be employed to increase sebum production by sebaceous glands to additionally drive sebum to the skin surface, such that the detector 100, 900, 2300, 2600, 2700, 3300 may extract and detect analytes emitting, excreting, or secreting from the sebum of a mammalian subject, including a human subject. All of these methods may be employed singly or in combination.

When using detectors 100, 900, 2300, 2600, 2700, 3300 on a wound, some of the analytes may be related to a bacterial infection, and others may be the result of the subject's own metabolism, including from external sources such as metabolized chemicals from food, drinks, and/or pharmaceuticals. It may be desirable to minimize detection or an effect of analytes that are not produced by the bacteria in the wound. Accordingly and as referred to above, it may improve accuracy of analysis to take a “control” detection of analytes and/or other substances on healthy skin (e.g., a target location) away from the wound site. Then, during analysis of the analytes taken from the wound site, the reading from the healthy skin may be subtracted from the reading on the wound site, substantially canceling out analytes that are unrelated to the wound itself. Alternatively or additionally, the readings from the wound site may be normalized in one or more other suitable manners.

It will be understood that in any of the embodiments described above, the analysis of detected analytes can be used to identify bacteria in a wound and/or to identify illnesses that alter the patient's metabolism in a way that elicits patterns of analytes specific to that particular illness. For example, the detected analytes and analyses thereof can be used to identify bacteria in a wound, identify illnesses that alter the subject's metabolism in a way that causes them to emit, secret, emanate, release, and/or excrete patterns analytes specific to that particular illness, identify a wellness of the subject (e.g., one or more analyses results in a measurement within a healthy range for the subject), and/or make one or more other suitable identifications or determinations.

A variety of methods may be utilized to analyze analytes detected with the detector 100, 900, 2300, 2600, 2700, 3300. Example detection and/or analysis devices include, but are not limited to, a metal oxide semiconductor (MOS) sensor-based device, a gas chromatography device (GC), a mass spectroscopy device (MS), GCMS, Raman spectroscopy device, near-infrared spectroscopy device (NIRS), a Fourier transform infrared spectroscopy device (FTIR spectroscopy), a terahertz spectroscopy device, a chemical detector, a detector array, a UV, Visible, Near-Infrared (NIR) or Short-Wave-Infrared (SWIR) spectrometer, a surface-enhanced Raman spectroscopy device (SERS), other suitable detection devices, and/or combinations thereof.

Hyperspectral imaging techniques and devices, similar to other spectral imaging techniques and devices, collect and process information from across the electromagnetic spectrum and may be useful for the analysis of detected analytes. The goal of such imaging is to obtain spectra for each pixel in an image, with the intent of finding objects, identifying materials, or detecting processes. Whereas the human eye sees color of only the visible light spectrum, in mostly three bands (long wavelengths—red, medium wavelengths—green, and short wavelengths—blue), hyperspectral imaging sees a broader range of wavelengths extending beyond the visible spectrum.

MS devices used to analyze detected analytes by the detector 100, 900, 2300, 2600, 2700, 3300 and methods described herein may require ionization of the detected substances. Example ionization techniques include, but are not limited to, electron impact (EI), thermal desorption (TD), electrospray ionization (ESI), atmospheric pressure chemical ionization (APCI), and any other suitable ambient ionization techniques such as DART and DESI after VOC and/or chemical substance desorption in order to analyze the collected sample.

Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as example forms of implementing the claims.

Unless otherwise expressly stated, it is in no way intended that any method set forth herein be construed as requiring that its steps be performed in a specific order. This holds for any possible non-express basis for interpretation, including matters of logic with respect to arrangement of steps or operational flow, plain meaning derived from grammatical organization or punctuation, and the number or type of embodiments described in the specification

It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention's scope is, of course, defined in the language in which the appended claims are expressed.

Number	Date	Country
63128048	Dec 2020	US
63128050	Dec 2020	US
63114734	Nov 2020	US
63111077	Nov 2020	US
63087128	Oct 2020	US

	Number	Date	Country
Parent	PCT/US2021/058272	Nov 2021	US
Child	18129707		US

	Number	Date	Country
Parent	PCT/US2021/053167	Oct 2021	US
Child	PCT/US2021/058272		US

DEVICES, METHODS, AND SYSTEMS TO COLLECT, STORE, AND ANALYZE CHEMICAL SUBSTANCES

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CROSS-REFERENCE TO RELATED APPLICATIONS

Provisional Applications (5)

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Continuation in Parts (1)