Improvements in or Relating to Ear Apparatus The present invention relates to an ear apparatus, for detecting airborne molecules within an ear-canal of a human or other animal. In particular, the present invention relates to detecting a molecular or chemical signature or indication of one or more airborne molecules or one or more types of airborne molecules.
Many current detection methods carried out on humans and other animals are invasive, e.g. blood testing, including venous samples or arterial samples (both painful and invasive). There are no present non-invasive apparatus which are unobtrusive, or which do not require a change in behaviour of the individual, nor has it been proposed to modify and adapt and, thereby, re-purpose commonplace electrical devices used in everyday tasks for new detection functions.
Breath sampling is known, but has limited application and is used in just a few areas of medical practice, such as FeNO (fractional exhaled nitric oxide) analysis, which provides an indication of the level of inflammation of the lungs and may be used as part of asthma diagnosis and monitoring. Obtaining breath samples requires a dedicated apparatus, and any detection of molecular components and their analysis is affected by passage through respiratory tissue, being affected by physiological breathing pattern changes. Use of such an apparatus cannot provide continuous, real-time analysis, and necessitates dedicated user engagement and behavioural change.
There presently exists no apparatus nor associated method for continuous, real-time analysis for molecular monitoring during normal activities or during exercise.
According to a first aspect, the present invention provides an ear apparatus, for detecting airborne molecules within an ear-canal of a human or other animal, the apparatus comprises: an ear-canal portion, configured to be adjacent said ear-canal and/or at least partially locatable within said ear-canal; wherein, the ear-canal portion comprises sensor means, configured to detect one or more airborne molecules, and/or one or more types of airborne molecules in ear-canal air.
Preferably, the apparatus comprises means for analysing ear-canal airborne molecular data output by the sensor means. Most preferably, the means for analysing is configured to identify an electronic signature associated with a defined scent or smell.
Preferably, the sensor means is configured to detect one or more airborne molecules, and/or one or more types of airborne molecules directly in ear-canal air.
Preferably, the sensor means comprises one or more electrochemical sensors. Most preferably, the sensor means comprises one or more graphenebased electronic sensors.
Preferably, at least part of the ear-canal portion is anatomically shaped and configured to locate at least part of the sensor means within an ear-canal volume of air and/or in fluidic contact with an/said ear-canal volume of air.
Preferably, the sensor means is shielded from direct contact with a wall of said ear-canal.
Preferably, the ear-canal portion comprises an aperture and channel capable of providing fluidic transfer from said ear-canal volume of air to the sensor means, 15 when the sensor means is internally mounted.
Preferably, the aperture comprises a protective, gas permeable membrane.
Preferably, fluidic transfer along the channel is passive. Alternatively, it may be active, providing increased airflow to the sensor means (with or without being ventilated to ambient air).
Preferably, the sensor means is mounted to an exterior surface of the ear-canal portion.
Preferably, the surface-mounted sensor means comprises a protective, gas permeable membrane.
Preferably, each sensor means is configured to: detect a molecular or chemical signature or indication of one or more molecules, or one or more types of molecules; detect a molecular or chemical signature or indication of one or more scents or smells; and/or be targeted at one or more specific molecules.
Preferably, the sensor means is configured to detect a molecular or chemical signature or indication of one or more VOCs (volatile organic compounds); gases; endogenous compounds; and/or exogenous compounds.
Preferably the sensor means is configured to detect one or more of the group comprising: scent; smell; gas(es), such as carbon dioxide, carbon monoxide, hydrogen, nitrogen, and/or nitric oxide; exogenous compounds, such as drugs (medical / illicit) and/or everyday environmental compounds / contaminants, including petrochemicals, smoke; alcohol; explosives; and/or endogenous compounds, such as ketones, cancer-related compounds / signatures, infection-related compounds / signatures, compounds reflecting internal carotid circulation supplying the brain, free blood, cerebrospinal fluid (CSF), hormones, and/or endogenous VOCs linked to specific conditions or illness and/or of presently unknown biological significance. The above list is non-exhaustive.
Preferably, the sensor means comprises an array of sensors configured to: detect a molecular or chemical signature or indication of one or more molecules, or one or more types of molecules; detect a molecular or chemical signature or indication of one or more scents or smells; and/or be targeted at one or more specific molecules.
Preferably, the array of sensors comprises a plurality of sensor means configured to detect molecular or chemical signatures or indications of different scents or smells; and/or be targeted at one or more different molecules. Preferably, the sensor means is configured to actively attract or passively receive one or more airborne molecules, and/or one or more types of airborne molecules. The sensor means may receive one or more airborne molecules, and/or one or more types of airborne molecules which have been pushed or directed towards the sensor means by appropriate means.
Preferably, the apparatus comprises processor means, capable of receiving an output from the sensor means and analysing the output to isolate an electronic signature of one or more target molecules / molecular combinations, and/or concentrations associated with one or more individual scents or smells. Preferably, the apparatus is configured to detect airborne molecules in: intra aural air; or intra aural air and ambient air.
Preferably, the ear apparatus comprises a housing, wherein the housing and/or ear-canal portion comprise one or more substantially arcuate or circumferential portions configured to substantially obstruct said ear-canal.
Preferably, the ear apparatus comprises an elongate channel extending from an intended external aspect of the ear apparatus to an intended internal aspect, for conveying fluid, ventilating said ear-canal, and/or for conveying additional sensor means to said ear-canal.
Preferably, the channel is passively or actively ventilated.
Preferably, when actively ventilated, the apparatus comprises one or more means for ventilating and/or one or more controllable air vents.
Preferably, the ear apparatus additionally comprises second sensor means configured to be externally located so as to detect airborne molecules in ambient air.
Preferably, the ear apparatus comprises an external portion locatable in a concha and/or pinna region of an ear of a human or other animal, the second sensor means being internally or surface mounted.
Preferably, the external portion comprises an aperture and channel capable of providing fluidic transfer from said ambient air to the sensor means. Further preferably, the aperture comprises a protective, gas permeable membrane. Most preferably, fluidic transfer along the channel is passive.
Alternatively, the second sensor means is mounted to an exterior surface of the external portion. Most preferably, the surface-mounted sensor means comprises a protective, gas permeable membrane.
Preferably, the processor means is configured to analyse and compare ear-canal airborne molecular data and ambient airborne molecular data.
Preferably, the sensor means is configured to reverse attachment of molecules, to detach airborne molecules.
Preferably, a transient current is utilised to detach molecules from the graphene-based sensor.
Preferably, the ear apparatus is ear-mounted, being an earpiece, earphone, hearing aid, earbuds or the like.
Alternatively, the ear apparatus is hand-held, optionally being part of a diagnostic apparatus such as an in-ear thermometer.
Preferably, the sensor means comprises, in addition to the above or in the alternative, airborne molecular spectroscopy means and/or gaseous spectroscopy 30 means.
According to a second aspect, the invention provides a method for detecting airborne molecules within an ear-canal of a human or other animal, the method comprising: locating at least part of a sensor means adjacent the ear-canal and/or at least partially within the ear-canal; detecting one or more airborne molecules, and/or one or more types of airborne molecules in ear-canal air.
Preferably, the method comprising locating at least part of the sensor means within an ear-canal volume of air and/or in fluidic contact with an/said ear-canal volume of air.
Preferably, the method comprising directly and/or passively detecting one or more airborne molecules, and/or one or more types of airborne molecules in ear-canal air, without active airflow or suction. In an alternative, actively generating airflow.
Preferably, detecting airborne molecules in: intra aural air; or intra aural air and ambient air.
Preferably, analysing an output of the sensor means to identify an electronic signature associated with a defined scent / smell.
Preferably, utilising a graphene-based electronic sensor means to detect one or more airborne molecules, and/or one or more types of airborne molecules in ear-canal air.
Preferably, utilising an array of sensors, comprising a plurality of sensor means, and detecting molecular or chemical signatures or indications of different scents or smells; and/or targeting one or more different molecules.
Preferably, the method comprising: detecting a molecular or chemical signature or indication of one or more molecules, or one or more types of molecules; detecting a molecular or chemical signature or indication of one or more scents or smells; targeting one or more specific molecules; and/or detecting a molecular or chemical signature or indication of one or more VOCs (volatile organic compounds); gases; endogenous compounds; and/or exogenous compounds.
Preferably detecting one or more of the group comprising: scent; smell; gas(es), such as carbon dioxide, carbon monoxide, hydrogen, nitrogen, and/or nitric oxide; exogenous compounds, such as drugs (medical / illicit) and/or everyday environmental compounds / contaminants, including petrochemicals, smoke; alcohol; explosives; and/or endogenous compounds, such as ketones, cancer-related compounds / signatures, infection-related compounds / signatures, compounds reflecting internal carotid circulation supplying the brain, free blood, cerebrospinal fluid (CSF), hormones, and/or endogenous VOCs linked to specific conditions or illness and/or of presently unknown biological significance. The above list is non-exhaustive.
Preferably, processor means receives an output from the sensor means and analyses the output to isolate an electronic signature of one or more target molecules / molecular combinations associated with an individual scent or smell.
Preferably, detecting and analysing in real-time.
Preferably, externally (of the ear-canal) locating a second sensor means and detecting airborne molecules in ambient air.
Preferably, analysing and comparing ear-canal airborne molecular data and ambient airborne molecular data. Most preferably, a/the processor means is configured to analyse and compare ear-canal airborne molecular data and ambient airborne molecular data.
Preferably, the method comprising: substantially obstructing the ear-canal during detection, to provide an/the enclosed ear-canal volume of air; passively ventilating the ear-canal; or actively ventilating the ear-canal.
Preferably, providing fluidic transfer from ear-canal air to an internally mounted sensor means. Most preferably, providing passive fluidic transfer to the internally mounted sensor means. In an alternative, preferably providing active fluidic transfer to the internally mounted sensor means.
Preferably, applying a transient current to detach molecules from a/the graphene-based sensor.
Preferably, the method comprising use of an ear apparatus according to any one or more features of the first aspect.
According to a third aspect, the invention provides use of an ear apparatus according to the first aspect to detect scents or smells within an ear-canal volume of air of a human or other animal.
Advantageously, the invention can be provided as an add-on to a known earphone or hand-held device, such as an ear thermometer, or as part of another multi-diagnostic apparatus. The invention may alternatively be a standalone diagnostic apparatus. Further, the invention may be provided as part of an in-ear biometrics apparatus, for detecting other biometric data from a human or other animal, including Raman, infrared and/or other spectroscopy data.
Advantageously, detection is localised, being preferably conducted directly in the ear-canal (ear-canal volume) and, further preferably, largely in an inner aspect of the ear-canal.
Advantageously, in a passive embodiment, airborne molecules are brought into direct contact with the sensor through diffusion through air in the ear-canal air, or air within or through the apparatus. The invention involves passive sampling which is, preferably, continuous. There is, preferably, no requirement for active sampling, nor any need for active airflow or suction to bring the airborne molecules into direct contact with the sensor and, thereby, no need for additional piping, motors, pumps or such mechanisms required for active sampling. Further, the invention has no need for a concentrator mechanism and does not require a change of filter(s), concentrator(s) or cartridge(s).
Advantageously, in an active embodiment, airflow is induced -by a fan or other means -and, thereby, further airborne molecules are brought into direct contact with the sensor.
Advantageously, detection of disease and/or health state is/are aided by molecular detection and quantification of biologically relevant molecules which may be endogenous (e.g. metabolites), exogenous (e.g. environmental toxins, drugs, etc.) and/or gases (e.g. carbon dioxide, oxygen or nitric oxide).
The invention avoids sampling from skin of the external ear, which is more prone to contamination caused by, for example, perfume or soap. Contamination and other adverse effects of storage or transport are reduced or prevented.
Advantageously, the invention may be used for exposure monitoring, such as with firefighters, providing detection of noxious gases within the bloodstream, and/or used as an alert.
Advantageously, when the invention comprises two airborne molecular sensors per earbud or diagnostic apparatus, an ear-canal sensor and external sensor, the sensors provide: external environmental (e.g. occupational) exposure information and blood level information (following or during exposure); or a comparison of in-ear gaseous levels with ambient gaseous levels, or those from outer ear-canal regions, from the skin of the pinna, etc. Advantageously, in-ear airborne detection may provide an improved representation of intracerebral metabolism (being diffused from middle-ear and ear-drum vessels which have blood supply, as contributed to by the internal carotid artery) as compared to outer-ear detection.
Advantageously, the invention may identify the presence of and/or a type of infection and/or bacteria present, through detecting a molecular or chemical signature or indication of a scent or smell associated with that infection. For example, Pseudomonas aerouginosa has a very characteristic aroma, and a molecular or chemical signature or indication thereof may be isolated from other molecular signatures.
The invention will now be disclosed, by way of example only, with reference to the following drawings, in which: Figure 1 is a schematic view of a first earbud embodiment of the present invention; Figure 2 is a schematic view of a second earbud embodiment of the present invention; Figures 3a and 3b are schematic views of a third earbud embodiment of the invention; Figure 4 is a schematic view of a fourth earbud embodiment of the invention; Figure 5 is a schematic view of a first hand-held diagnostic apparatus embodiment of the invention; Figure 6 is a schematic view of a second hand-held diagnostic apparatus embodiment; and Figure 7 is a schematic view of a fifth earbud embodiment.
Each of the following embodiments is generally concerned with an ear apparatus, for detecting airborne molecules within an ear-canal of a human or other animal. Each apparatus includes an ear-canal portion, at least part of which is configured to be locatable adjacent the ear-canal of an individual or at least partially locatable within the ear-canal of an individual, and the ear-canal portion includes a sensor means which is configured to detect one or more airborne molecules and/or one or more types of airborne molecules in the ear-canal. An output of the sensor means is analysed by a processor to identify electronic signatures associated with one or more defined scents or smells.
The sensor means is, thereby, located in the ear-canal or adjacent the ear-canal (preferably, at the opening of the ear-canal of the pinna), where it can detect airborne molecules in or from the ear-canal.
In each embodiment, a sensor is configured to: detect a molecular or chemical signature or indication of one or more molecules or one or more types of molecules; detect a molecular or chemical signature or indication of one or more scents or smells; and/or be targeted at one or more specific molecules.
The sensor is a graphene-based sensor, and airborne molecules from or within the ear-canal come into direct contact with the sensor, so that a molecular or chemical signature or indication of those molecules can be detected and an electronic signature -outputted by the sensor -be analysed. The sensor may be provided on a chip (integrated circuit) or as part of a printed circuit board. The sensor may be a 3-D printed version, printed directly onto a surface -with or without application of fluidic dye or material (e.g. graphene-based dye) -or within, a normal earbud, hearing aid, diagnostic apparatus, or the like. Gaseous molecules attach to the sensor during detection, and the sensor, thereby, detects a molecular or chemical signature or indication associated with the attached molecules, and outputs an electronic signature or indication representing the molecule(s) or chemical(s) detected. Specifically, the sensor demonstrates a change in resistance over time or other electrical characteristic, such as current or voltage -by attachment of the gaseous molecules to the sensor. The change in resistance, thereby, provides an electronic signature or indication of those molecules detected. Accordingly, the sensors typically require very low power, and the data requires little signal processing. Further advantageously, application of transient current detaches airborne molecules from the graphene-based sensor. The sensor may be a single sensor or array of several sensors, designed to detect and/or be sensitive to specific molecules, including different molecules. In a variant, the sensors may be configured to provide gaseous spectroscopy on a single chip, rather than requiring an array or collection of multiple sensors, each with different characteristics.
Preferably, the sensor is a graphene field-effect transistor (GFET) or graphene resistor.
If the sensor is highly specific, perhaps to just one type of molecules, the sensor detects a molecular or chemical indication (rather than a complex signature) associated with the attached molecule(s), and outputs an electronic indication representing a parameter or characteristic of the molecule(s) or chemical(s) detected. Such a parameter or characteristic may be a change in concentration over time.
In an alternative, the sensor may be an electrochemical sensor configured to 10 detect one or more airborne molecules and/or one or more types of airborne molecules in ear-canal air.
Analysis broadly involves determining the presence of certain or specific (target) molecules, combinations and/or concentrations thereof, which are the cause of various scents or smells, so as to provide a detection mechanism akin to a sense of smell, the results of which may be used for further detection and/or analysis.
Each embodiment includes a requisite power source and a processor, for receiving an output from the sensor, being an electronic signature or indication of those molecules detected. The processor, and its associated algorithm, analyse the electronic signature or indication and determine which molecules have been detected, or combinations of molecules, so as to identify one or more scents or smells. Although the processor is preferably located as part of an earbud or diagnostic apparatus, this is not essential and the sensor (or its components) may be configured to communicate either wirelessly, or through wired connections, with an external processor and/or computer for data analysis/storage.
Each embodiment may include a second sensor which is configured to be externally located and, thereby, not directed towards the ear-canal nor intended to detect airborne molecules in the ear-canal. The second sensor is also, preferably, a similar sensor to the first sensor, being by way of example a graphene-based sensor of similar specificity (although this is not essential), and airborne molecules from ambient air come into direct contact with the externally located sensor, so that a molecular or chemical signature or indication of those molecules can be detected, and an electronic signature or indication be provided as an output, for subsequent analysis. The second sensor is located so as to detect airborne molecules in ambient air and the processor -either located in the earbud or diagnostic apparatus, or externally located -and its algorithm are configured to analyse data relating to ambient airborne molecules or combinations thereof, which are the cause of various scents or smells, and compare ear-canal molecular data and ambient airborne molecular data. The results of which may be used for further detection and/or analysis. Such a comparison may include a Wheatstone bridge system. For example, ear-canal levels / concentrations of carbon dioxide may be compared to ambient levels / concentrations of carbon dioxide, providing more sensitive and/or contextual analysis.
Although passive detection is preferred, airflow may be improved in each embodiment by use of appropriate means for inducing airflow to the sensor.
Each of embodiments 1 to 4 and 7 describe an earbud embodiment which includes an audio driver. Those skilled in the art will understand that such earbuds may be earphones, having associated electronics for directing sound to an ear-drum of an individual, or may be hearing aids, which may include a microphone for replicating speech and sound to those in need of hearing assistance. The standard functions of earphones and hearing aids will not be described further and the following concentrates on the features corresponding to the present invention.
Earbuds of the present invention may be configured to have one of three general forms, being: obstructed, in which the earbud substantially obstructs the ear-canal, providing an enclosed volume, which improves isolation and increases its ability to detect airborne molecules in the ear-canal (preferred for detection of abnormal substances, such as drugs, explosives exposure, ketones in Type 1 diabetic patients, cancer marker detection, etc.); ventilated, in which the earbud includes a ventilation channel for ventilating the ear-canal, preferred for extended wear, and providing real-time detection and analysis (for such things as real-time changes in blood concentration, real-time quantification of molecular levels, such as carbon dioxide, nitric oxide, etc.); and actively ventilated, in which the earbud includes a ventilation channel through which ventilation can be actively controlled (for example using MEMS (micro-electromechanical systems) to control air vents, or fans, in hearing aids.
Further, the earbud embodiments are shaped and dimensioned for use with humans -although those skilled in the art will know that small modifications to size / shape would, without deviating from the invention, provide earbuds for use with other animals.
In a variant, a location of the sensor within the ear-canal may be adjusted or controlled, so as to improve detection.
Prior to detection and analysis, the earbud is located in an ear of the individual, so as to locate the sensor adjacent or within the ear-canal of the individual, from where detection and analysis of airborne molecules located in the ear-canal of the individual may be conducted as described above.
Earbuds of the invention have various proposed uses, including detecting ketones as a medical monitoring / warning device for people with Type 1 diabetes at risk of keto-acidosis. Further examples are provided just before the claims.
Earbuds of the invention may also be an apparatus used to detect performance, and health and fitness monitoring for humans and/or animals. For example, as part of audio earphones worn during normal daily activities and/or during exercise.
Figure 1 shows a first embodiment of earbud, generally identified by reference 10. The earbud 10 includes an ear-canal portion 11 and an outer ear portion 12. The ear-canal portion 11 is sized and shaped to be locatable in an ear-canal (not shown) of an individual -which theoretically could be a human or other animal -and the ear-canal portion 11 further includes a sensor 13, which may be located towards a distal end 14 of the ear-canal portion 11 or along a side portion 15 of the ear-canal portion 11. The sensor 13 may include a protective, gas-permeable cover 13a. The outer ear portion 12 is shaped and dimensioned to be received in a concha and pinna of the individual (not shown).
In use, detection of a molecular / chemical signature or indication of one or more molecules, one or more types of molecules, one or more scents and/or smells and analysis of the resulting electronic signature of the one or more molecules, one or more types of molecules, one or more scents and/or smells is conducted as described above.
Figure 2 shows a second earbud embodiment, identified generally by reference 20. The earbud 20 includes an ear-canal portion 21 and an outer-ear portion 22. The ear-canal portion 21 includes an aperture 23 and channel 24, extending inwardly from a distal end 25 of the ear-canal portion 21. A sensor 26 is located along the channel 24 and, thereby, internally located with respect to the earbud 20, but provided in fluidic communication with an ear-canal of an individual through the channel 24 and its aperture 23. The channel 24 provides gaseous diffusion of airborne molecules into and out from the channel 24, so as to bring those airborne molecules into direct contact with the sensor 26. The outer ear portion 22 is shaped and dimensioned to be received in a concha and pinna of the individual (not shown).
In use, detection and analysis is conducted as described above.
Figures 3a and 3b show a third earbud embodiment, generally identified by reference 30. The earbud 30 includes an ear-canal portion 31 and an outer-ear portion 32. An audio driver 33 is shown, which alludes to other functions of the earbud 30, such as those when it may be used as an earphone or hearing aid; however, these functions will not be described further. A ventilation channel 34 is provided internally within the ear-canal portion 31 and outer-ear portion 32, so as to provide ventilation to the ear-canal of the individual. Ventilation channel 34a extends through the ear-canal portion 31 to a sensor 35 -thereby, internally located with respect to the earbud 30 -and ventilation channel 34b extends from the sensor 35 through the outer-ear portion 32 to ambient air. Accordingly, ambient air may easily pass through the earbud 30 and ventilate the ear-canal of the individual. The sensor 35 in this configuration may come into direct contact with airborne molecules from the ear-canal of the individual and/or airborne molecules from ambient air.
In a variant, one may control an amount or extent of ventilation so as to allow less or more ventilation, or even none at all if the sensor is required to detect airborne molecules from the ear-canal only. Such control may be achieved through use of one or more baffles, or closures, or active ventilation, such as a fan or the like for increasing airflow.
In use, detection and analysis is conducted as described above.
Figure 4 shows a fourth earbud embodiment, identified generally by reference 40. Earbud 40 includes an ear-canal portion 41, in the form of an in-ear limb 41, and an outer-ear portion 42. An audio driver 43 is shown on an inwardly facing part of the outer-ear portion 42, for directing sound towards an ear-drum of an individual; however, this aspect will not be described further. The ear limb 41 is dimensioned and shaped so as to extend into an ear-canal of the individual, preferably without blocking the ear-canal, and is an elongate limb 41 so as to locate a sensor 44 further along the ear-canal and/or in proximity to an ear-drum of the individual. The sensor 44 may include a protective, gas-permeable cover 44a.
In use, detection and analysis is conducted as described above.
Both of Figures 5 and 6 relate to a hand-held diagnostic apparatus for use within an ear of a human or other animal. The diagnostic apparatus may have various other functions, as required and desired in addition to the invention or be a stand-alone diagnostic apparatus; however, these additional functions will not be described in detail, save as follows. As shown in Figures 5 and 6, the apparatus is based upon an exemplary ear thermometer and includes a thermo-sensor, for taking measurements from an ear of an individual. Those skilled in the art will understand that, in addition or instead of the thermo-sensor, the apparatus may have different or additional sensors.
Further, the hand-held diagnostic apparatus is shaped and dimensioned for use with humans -although those skilled in the art will know that small modifications to size / shape would, without deviating from the invention, provide an apparatus for use with other animals.
Hand-held diagnostic apparatus of the invention may be used within a medical / healthcare setting, at home or in any other environment where detection and/or monitoring is required.
Figure 5 shows a first embodiment of hand-held diagnostic apparatus, identified generally by reference 50. The apparatus 50 includes an ear portion 51 and a hand-held portion 52. The ear portion 51 has a frustoconical shape extending towards a distal end 53 for receipt within an ear-canal of an individual. The distal end 53 includes a sensor 54, being positioned where airborne molecules may make direct contact with the sensor and, thereby, be detected. The sensor may include a protective, gas permeable cover 54a. The distal end 53 also includes a thermosensor 55 for detecting body temperature from the ear-canal; however, this will not be described further. Accordingly, sensor 54 is externally mounted / located with respect to the apparatus 50.
The hand-held portion 52 provides a handle which may include various electronic components, for example a power supply and processor -although the processor may be externally located -and provides a convenient way the apparatus 50 may be held by a medical practitioner.
In use, the distal end 53 of the frustoconical portion 51 is located within an ear of an individual, from where detection and analysis of airborne molecules located in the ear-canal of the individual may be conducted, as described above.
Figure 6 shows a second embodiment of hand-held diagnostic apparatus, identified generally by reference 60. The apparatus 60 includes an ear-portion 61 and a hand-held portion 62. Apparatus 60 is similar to apparatus 50 and, so, only the differences will be discussed in detail. Apparatus 60 includes an internally mounted sensor 63 and includes a ventilation channel 64, having parts 64a and 64b, which extend through the apparatus 60. Part 64a extends from an aperture 65 located at distal end 65a of the frustoconical ear portion 61 to the sensor 63; part 64b extends from the sensor 63 through a part of the ear portion 61 and through a part of the hand-held portion 62, where it exits the hand-held portion 62 at aperture 66. A thermo-sensor 67 is provided towards the distal end 65a of ear portion 61, but will not be described in more detail. Ventilation channel 64 extends right through apparatus 60 and, thereby, provides ambient air ventilation to the ear-canal of the individual.
In a variant, one may control an amount or extent of ventilation so as to allow less or more ventilation, or even none at all if the sensor is required to detect airborne molecules from the ear-canal only. Such control may be achieved through use of one or more baffles, or closures, or active ventilation, including a fan (not shown) which is located within the apparatus 60 and which may draw air through ventilation channel 64 to provide increased airflow.
In use, the distal end 65a of the frustoconical portion 61 is located within an ear of an individual, from where detection and analysis of airborne molecules located in the ear-canal of the individual may be conducted, as described above.
Figure 7 shows a fifth earbud embodiment, identified generally by reference 70. Earbud 70 is based upon earbud 10 of Figure 1 and has common components which will not be described again. In addition to those components, earbud 70 includes an external sensor 71 which is located on the outer-ear portion 12 so as to be capable of detecting airborne molecules from ambient air.
It should be noted that such an external sensor may be included on any of the embodiments relating to Figures 2 to 6, although these will not be described separately.
Detection and analysis from the first and second sensors, one being an ear-canal sensor and the other an ambient air sensor, is conducted as described above.
The following provides an non-exhaustive list of target molecules or compounds and, where applicable, an exemplary use for such detection: carbon dioxide -COPD (chronic obstructive pulmonary disease), asthma and ventilation monitoring on ITU (intensive therapy unit); carbon monoxide -poisoning and smoking; nitrogen -nitrogen narcosis; nitric oxide -inflammation e.g. in asthma; ketones -Type 1 diabetics, ketoacidosis and athletic performance / fatigue / lack of food/ ketogenic and/or fasting diet monitoring; cancer related signatures of compounds -diffused from blood -representing distant cancers such as lung, colorectal, etc.; otitis media -detection of localised infection in the ear; volatile organic compounds -reflecting blood components from the internal carotid circulation supplying the brain (diffused from ear-drum blood supply or through the ear-drum from the middle ear, as supplied by a branch of the internal carotid artery); free blood -after trauma, e.g. after a basal skull fracture; cerebrospinal fluid (CSF) -after trauma, e.g. after a basal skull fracture; hormones; volatile organic compounds -categorisation in assisting determination of disease types, e.g. cancer; and/or drugs (medical / illicit), environmental exposure, alcohol, or evidence of explosives handling, etc. More generally, those skilled in the art will understand that the invention has various potential uses (either alternatively or in addition to the above) including: exercise monitoring and assessment, and muscle disease states, where isoprene (from muscle cells), acetone and methane concentrations may be detected during exercise; detecting and monitoring metabolic disorders where, for example, amino acid levels -such as phenyl-ketonuria -may provide feedback so as to enable adjustment of therapy / treatment (i.e. diet); safety, including monitoring exposure and risk in chemical, biological, radiological, and/or nuclear incidences and/or early detection of alcohol intoxication or exposure to toxic industrial chemicals; sport and regulatory requirements, for example, detection of dopant drugs such as fentanyl, propofol, and tetrahydrocannabionol; and/or identification and quantification of recreational drugs, e.g. as an alternative to blood and urine testing. The above list is non-exhaustive.
Those skilled in the art will further understand the invention may be used to detect various chemicals and substances having an aroma, including alkanes, alkenes, alkynes, benzyl, and phenyl hydro-carbons, alcohols, ethers, aldehydes, acids, esters, ketones, nitrogen-containing volatiles, sulphur-containing volatiles, and/or halogen-containing volatiles. The above includes specific examples being methane, acetone, fumaric, succinic, malic, keto-glutaric, oxaloacetic, and aconitic acids, and/or trimethylsilyl acetonitrile (e.g. in smokers), or drugs such as propofol, valproic acid, eucalyptol, salbutamol, and/or ketamine. The above list is non-exhaustive.
Although the apparatus of the invention may be termed a diagnostic apparatus (this being a generic term for a variety of different medical apparatus), or be an add-on to such an apparatus, that is not to say that its use provides direct diagnosis of medical conditions. The apparatus and method are directed to obtaining information from a human or other animal, for example biometric data, for further analysis, and conducting the gathering of such information is not considered excluded subject-matter.