Infrared Otoscope for Characterization of Effusion
An otoscope uses differential reflected response of optical energy at an absorption range and an adjacent wavelength range to determine the presence of water (where the wavelengths are water absorption wavelength and adjacent non-absorption excitation wavelengths). In another example of the invention, the otoscope utilizes OCT in combination with absorption and non-absorption range for bacteria and water.
The present invention relates to an otoscope for characterization of fluid in an ear. In particular, the invention relates to the detection of bacteria in a fluid opposite a membrane using a measurement of optical properties of the fluid and bacteria using one or more dual wavelength optical sources and a detector which is exclusively responsive to a particular source during a particular time interval.
BACKGROUND OF THE INVENTIONAcute Otitis Media (AOM) is a common disease of the inner ear, involving tissue inflammation and fluidic pressure which impinges on the tympanic membrane. Acute Otitis Media may be caused by a viral infection, which generally resolves without treatment, or it may be caused by a bacterial infection, which may progress and cause hearing loss or other deleterious and irreversible effects. Unfortunately, it is difficult to distinguish between viral or bacterial infection using currently available diagnostic devices, and the treatment methods for the two underlying infections are quite different. For bacterial infections, antibiotics are the treatment of choice, whereas for viral infections, the infection tends to self-resolve, and antibiotics are not only ineffective, but may result in an antibiotic resistance which would make them less effective in treating a subsequent bacterial infection. It is important to accurately diagnose acute otitis media, as AOM can be a precursor to chronic otitis media with effusion (COME), for which surgical drainage of the effusion and insertion of a tube in the tympanic membrane is indicated.
The definitive diagnostic tool for inner ear infections is myringotomy, an invasive procedure which involves incisions into the tympanic membrane, withdrawal of fluid, and examination of the effusion fluid under a microscope to identify the infectious agent in the effusion. Because of complications from this procedure, it is only used in severe cases. This presents a dilemma for medical practitioners, as the prescription of antibiotics for a viral infection is believed to be responsible for the evolution of antibiotic resistance in bacteria, which may result in more serious consequences later in life, and with no efficacious treatment outcome, as treatment of viral infectious agents with antibiotics is ineffective. An improved diagnostic tool for the diagnosis of acute otitis media is desired.
OBJECTS OF THE INVENTIONA first object of the invention is a device for measurement of infectious agents present in an individual suspected of suffering from acute otitis media, the device having a plurality of optical sources, each optical source operative at a unique wavelength or range of wavelengths, each optical source operative within a particular range of wavelengths for an interval of time which is exclusive from the interval of time when optical sources at other wavelengths are operative, the device having a detector for measurement of reflected optical energy, the detector measuring a ratio of detected optical energy at a first wavelength to detected optical energy at a second or third wavelength, thereafter forming a ratio metric value as a proxy for estimated bacterial load.
A second object of the invention is a method for determination of bacterial concentration by successively illuminating a first surface of a membrane using a first and second wavelength at exclusive time intervals, measuring the reflected optical energy from the opposite surface of the membrane during each associated interval, forming a ratio of the first wavelength and second wavelength detector responses from the associated illumination events, each illumination event at a unique wavelength or range of wavelengths, where at least one of the illumination wavelengths corresponds to a bacterial absorption band, and another of the illumination wavelengths is in a wavelength with non-absorption or non-scattering characteristic for a bacterial colony or group of dispersed bacterium.
A third object of the invention is a speculum tip for insertion into an ear canal, one or more pairs of optical sources, each optical source coupling an optical output through the speculum tip, each optical source operative in a unique wavelength or range of wavelengths, each pair of optical sources generating a first optical output at a first wavelength selected for reflective attenuation for either watery fluid or bacteria, and also generating a second wavelength selected for comparative non-attenuation reflection for either watery fluid or bacteria, the second wavelength operative near the first wavelength, where reflected optical energy from the tympanic membrane is directed to a detector responsive to each optical source wavelength for optical energy reflected into the speculum tip, the detector coupled to a controller measuring a ratio of detector response from said first and said second wavelength, thereby forming a metric indicating the presence of bacteria and/or watery fluid from the detector response ratio associated with each pair of emitters.
SUMMARY OF THE INVENTIONIn a first example of the invention, a controller enables one of a first plurality of optical sources, or alternatively a single first optical source at a wavelength for bacterial absorption, and one of a second plurality of optical sources, or alternatively a second optical source operative at an adjacent wavelength which is non-absorptive for bacteria, an optional third source operative at a wavelength absorptive for watery fluid and an optional fourth source operative at an adjacent non-absorptive wavelength for watery fluid, each optical source or sources optionally operative at alternating or exclusive intervals of time. Each wavelength source is optically coupled through a tapered speculum which is inserted into the ear canal of a subject to be examined. The optical beam from each optical source may be carried as a directed beam, or the optical beam may be carried in an annular light guide or light pipe which surrounds the speculum, the optical energy from the illumination configuration impinging onto a front (distal) surface of a tympanic membrane, the tympanic membrane having a bacterial film or bacterial fluid on an opposite (proximal) surface of the tympanic membrane to be characterized. Reflected optical energy is coupled into the speculum tip to a single detector having a first wavelength response for energy reflected from the first source and a second wavelength response for energy reflected from the second wavelength source, or to separate detectors which are operative in each optical wavelength range of a respective optical source. The first wavelength response and second wavelength response are averaged over the associated interval the respective optical source is enabled to form an average measurement for each first wavelength response and each second wavelength response, and a ratio is formed from the two measurements. A first wavelength is in an absorption or scattering range of wavelengths for a bacterium to be characterized, and a second of the wavelengths is adjacent to the first wavelength and outside of the bacterial scattering or absorption wavelength. The response ratio for the first and second wavelength is applied to a polynomial or to a look-up table which provides an estimate of bacterial load from the ratio of power in the first wavelength to the power in the second wavelength, optionally compensating for the wavelength specific attenuation when absorptive or scattering fluid is not present, for example by using a stored wavelength scaling coefficient which compensates for scattering alone. A similar ratio for the detector responses associated with the third and fourth wavelength sources which are in adjacent absorptive and non-absorptive wavelengths, respectively, for water may be formed as well.
In a second example of the invention providing axial extent specificity over the region of measurement, the first and second wavelength sources are selected as adjacent wavelengths for absorption response and non-absorption response for bacteria, and also have a short coherence length, with the optical output of each source directed to the proximal surface of the tympanic membrane and middle ear to be characterized after splitting the optical energy into a measurement path and a reference path. The measurement path directs optical energy to the fluid to be characterized having a length equal to the reference path, the reflected optical energy from the measured path and reflected path are combined, thereby forming a coherent response over a narrow depth range, which is set to include the proximal surface of the tympanic membrane and middle ear region to be characterized. The first wavelength source and second wavelength source are enabled during exclusive intervals of time, and the combined measurement path and reference path optical energy directed to a detector response to the associated wavelengths. The first wavelength detector response and second wavelength detector response form a ratio which is used as a bacterial load metric, the ratio metric acting as a proxy for detection of the presence of bacteria. The third and fourth wavelengths are selected as in the first example to be adjacent but comparatively scattering and non-scattering for watery fluid, and used to form a second ratio which acts as a proxy for detection of watery fluid in the selected axial extent.
For the first or second example, by combining the second metric (presence of watery fluid) with the first metric (presence of bacteria), a more complete survey of the scope of acute otitis media may be determined.
The wavelength metric may be used to estimate the likelihood of presence of bacteria or bacterial load in the inner ear fluid on the opposite (proximal) surface of the tympanic membrane 120.
In an illustrative example,
optionally after which each wavelength λ3 and λ4 are commutated during exclusive intervals 402 and 404 to form fluid metric
Each corresponding metric may then be compared with a threshold for each metric to arrive at an estimated likelihood of presence of fluid or presence of bacteria. In one example of the invention, the respective bacterial or water fluid detector wavelength responses may be corrected for wavelength-specific attenuation or scattering (in the absence of watery fluid or bacteria) so that each pair of wavelengths (pathogen specific and adjacent) provide a unity metric ratio
when bacteria or watery fluid, respectively, are not present.
For the attenuation plot of
As described in the previous response plots, the ratio of reflected signal λ1/λ2 may be used to estimate bacterial concentration, and the ratio of reflected signal λ3/λ4 may be used to estimate fluid presence adjacent to the tympanic membrane, and the ratio may compensate for lower amplitude response from shorter wavelengths (having more Rayleigh scattering) of each pair of wavelengths such that the ratio is normalized to 1 for the absence of either bacteria or watery fluid in each respective ratio.
The foregoing is a description of preferred embodiments of the invention. It is understood that various substitutions can be made without limitation to the scope of the invention. For example, other wavelengths may be preferable for bacterial absorption or water absorption than those specified.
Claims
1. A device for characterization of a liquid which is either watery fluid or bacteria adjacent to a tympanic membrane, the device comprising:
- a speculum tip for insertion into an ear canal;
- one or more pairs of optical sources, each optical source of a pair coupling an optical output through the speculum tip, each optical source of a pair operative in a unique wavelength or range of wavelengths, each pair of optical sources generating a first optical output at a first wavelength selected for reflective attenuation for either watery fluid or bacteria, and also generating a second wavelength selected for comparative non-attenuative reflection for either watery fluid or bacteria, the second wavelength operative near the first wavelength;
- a detector responsive to each optical source wavelength for optical energy reflected into the speculum tip;
- a controller measuring a ratio of detector response from said first and said second wavelength of each said optical source pair;
- the controller forming a metric indicating the presence of bacteria or watery fluid from a detector ratio associated with the detector response for each optical source wavelength pair.
2. The device of claim 1 where the optical detector comprises a first detector responsive to a first wavelength and transparent to a second wavelength positioned in front of a second detector responsive to a second wavelength.
3. The device of claim 1 where the optical detector comprises a diffraction grating for separating wavelengths which are applied to a first detector placed with an edge adjacent to a second detector.
4. The device of claim 1 where said first wavelength is in the range 1050 nm to 1150 nm, and the second wavelength is below 1050 nm.
5. The device of claim 2 where, for each pair of optical sources, said optical source first wavelength and said optical source second wavelength are operative at exclusive intervals of time.
6. The device of claim 3 where, for each pair of optical sources, said optical source first wavelength and said optical source second wavelength are operative concurrently.
7. The device of claim 1 where, for each pair of optical sources, said optical source first wavelength and said optical source second wavelength are coupled through an annular light guide formed by the speculum tip.
8. The device of claim 1 where optical energy reflected into the speculum tip is focused onto said detector using one or more lenses.
9. The device of claim 1 where optical energy reflected into the speculum tip is guided onto said detector using reflective coatings inside the speculum tip.
10. The device of claim 1 where, for each pair of optical wavelengths, an effusion metric is formed from the ratio of optical energy reflected onto said detector at said first wavelength to the optical energy reflected onto said detector at said second wavelength for each said pair of optical sources.
11. A device for the measurement of bacterial or watery fluid adjacent to a membrane, the device having:
- a speculum tip for insertion into a subject's ear canal;
- a plurality of low coherence optical sources, each said optical source operative at a unique wavelength, said plurality of optical sources including a first wavelength which is absorptive for a bacteria of interest, a second wavelength which is comparatively less absorptive for a bacteria of interest, a third wavelength which is absorptive for watery fluid, and a fourth wavelength which is not absorptive for watery fluid;
- said plurality of low coherent optical sources coupled through a first splitter, said first splitter having an output directed to a second splitter which divides incoming optical energy into a reference optical path and a measurement optical path;
- said reference optical path coupled to a reflector having a path length equal to a measurement path length of interest;
- said measurement optical path directed to a tympanic membrane to characterize;
- reflected optical energy from said measurement optical path and said reference optical path combining at said second splitter, said optical energy thereafter directed to said first splitter and to a detector;
- said detector forming a first metric based on the ratio of reflected optical energy at said first wavelength to the reflected optical energy at said second wavelength;
- said detector forming a second metric based on the ratio of reflected optical energy at said third wavelength to the reflected optical energy at said fourth wavelength.
12. The device of claim 11 where the optical detector comprises a first detector responsive to a first wavelength and transparent to a second wavelength positioned in front of a second detector responsive to a second wavelength.
13. The device of claim 11 where the optical detector comprises a diffraction grating for separating wavelengths which are applied to a first detector placed with an edge adjacent to a second detector.
14. The device of claim 11 where said first wavelength is in the range 1050 nm to 1150 nm, and the second wavelength is below 1050 nm.
15. The device of claim 12 where said optical source first wavelength and said optical source second wavelength are operative at exclusive intervals of time.
16. The device of claim 13 where said optical source first wavelength and said optical source second wavelength are operative concurrently.
17. The device of claim 1 where said optical source first wavelength and said optical source second wavelength are coupled through an annular light guide formed by the shell thickness of the speculum tip.
18. The device of claim 11 where said first splitter, said second splitter, said reference optical path and part of said measurement optical path are formed form optical fiber.
19. The device of claim 11 where said first splitter, said second splitter, said reference optical path and said optical path are formed using mirrors and lenses.
20. The device of claim 1, where said metric comprises an indication of the presence of a virus.
21. The device of claim 11, where said metric comprises an indication of the presence of a virus.
22. The device of claim 1, wherein one or more of the first or second wavelengths are selected to maximize the ratio of detector response from the first wavelength to the second wavelength.
23. The device of claim 11, wherein one or more of the first or second wavelengths are selected to maximize the ratio of the reflected optical energy at said first wavelength to the reflected optical energy at the second wavelength.
24. The device of claim 11, wherein one or more of the third or fourth wavelengths are selected to maximize the ratio of the reflected optical energy at said third wavelength to the reflected optical energy at the fourth wavelength.
25. The device of claim 1, wherein said watery fluid comprises a viral effusion.
26. The device of claim 11, wherein said watery fluid comprises a viral effusion.
27. The device of claim 1, wherein said metric comprises an indication of the presence of a bacterial infection.
28. The device of claim 11, wherein said metric comprises an indication of the presence of a bacterial infection.
Type: Application
Filed: May 31, 2017
Publication Date: Jul 4, 2019
Inventors: Jay A. CHESAVAGE (Palo Alto, CA), Mark A. MOEHRING (Seattle, WA), George A GATES (Boerne, TX), Daniel KREINDLER (Foster City, CA)
Application Number: 15/609,015