Patent Application
20240016377
Acute otitis media (AOM) is an inflammatory process in the middle ear and is the most common clinical condition seen by pediatricians in children fifteen years and younger. AOM is generally associated with the presence of a middle ear effusion and is considered a middle ear inflammation. Complications of undiagnosed AOM can include hearing loss. Left untreated in children, recurrent AOM can also lead to delays in the development of speech and language skills.
The likelihood of obtaining an accurate diagnosis using existing non-invasive methods may be no better than 50%. Further, existing non-invasive methods may only be useful in identifying the presence of an effusion, and they often provide no information regarding the type of effusion. Because of the risks associated with undiagnosed AOM and the recognized unreliability of existing diagnostic tests, patients are often prescribed antibiotics, which may be ineffective in treating viral effusion. In addition to the increased cost burden of unnecessary antibiotic treatment, the patients are exposed to the side effects of antibiotics and the attendant and significant risk of developing antibiotic resistance.
Devices and methods described herein may improve upon existing non-invasive techniques by measuring ultrasound data reflected from a biological membrane coincident with a pneumatic excitation. The size of a diagnostic target may be small, and ultrasound is not visible to a human eye. An optical source and detection system may be provided. The optical source and detection system may facilitate alignment of the ultrasound beam. As the size of a biological lumen may be small, the optical source and detection system may be space efficient. The present disclosure provides improvements to delivering optical illumination to a target. The present disclosure provides improvements receiving optical illumination from a target in the presence of an obstruction.
In an aspect, the present disclosure provides a speculum operable to be disposed within an ear of a subject. The speculum may comprise a housing comprising a light conducting element, wherein a transmitted optical illumination is conducted by total internal reflection via the light conducting element, wherein the housing has a lumen therewithin, and wherein the housing is configured to allow a reflected optical illumination to propagate through the lumen; and one or more coupling portions which couple the transmitted optical illumination from a light source to the light conducting element, wherein the one or more coupling portions are shaped as a conic section.
In another aspect, the present disclosure provides an otoscope. The otoscope may comprise: a speculum and having a lumen therewithin and comprising a light conducting element, wherein a transmitted optical illumination is conducted by total internal reflection by the light conducting element, and wherein a reflected optical illumination is propagated through the lumen of the speculum; and one or more coupling portions which couple the transmitted optical illumination from a light source to the light conducting element, wherein the one or more coupling portions are shaped as a conic section.
In another aspect, the present disclosure provides a method of using an otoscope. The method may comprise: directing optical illumination of a light source to one or more coupling portions, wherein the one or more coupling portions are shaped as a conic section; collimating the optical illumination using the one or more coupling portions; directing the optical illumination from the one or more coupling portions to a light conducting element, wherein the optical illumination is conducted by total internal reflection by the light conducting element; and collecting reflected optical illumination from a target within a lumen of the housing, wherein the housing comprises a portion of a speculum of an otoscope.
In some embodiments, the method further comprises directing pneumatic excitation toward the target. In some embodiments, the method further comprises directing ultrasound and/or illumination toward the target. In some embodiments, the method further comprises measuring a response of the target to the pneumatic excitation in a reflected ultrasound signal. In some embodiments, the method further comprises determining a state or condition of a subject based on the reflected optical illumination and the response.
In another aspect, the disclosure provides a speculum operable to be disposed within an ear of a subject, the speculum comprising: a housing comprising a light conducting element, wherein a transmitted optical illumination is conducted by total internal reflection via the light conducting element, wherein the housing has a lumen therewithin, and wherein the housing is configured to allow a reflected optical illumination to propagate through the lumen; and one or more coupling portions which couple the transmitted optical illumination from a light source to the light conducting element, wherein the one or more coupling portions are shaped as a conic section. In some embodiments, the device further comprises an insert, wherein the insert is configured to be mechanically coupled to the housing. In some embodiments, the insert comprises a lens, an ultrasound transducer, one or more electrical leads electrically coupled to the ultrasound transducer, one or more wires electrically coupled to the one or more electrical leads and the ultrasound transducer, or any combination thereof. In some embodiments, the ultrasound transducer comprises a capacitive micromachined ultrasonic transducer. In some embodiments, the light conducting element comprises an ellipsoid shape. In some embodiments, the light conducting element is configured to be a parabolic mirror when light rays of the light source interact with the light conducting element. In some embodiments, the light conducting element comprises a launch point. In some embodiments, the light conducting element comprises one or more launch points. In some embodiments, the launch points comprise a geometry, wherein the geometry comprises: flat, circular, oval, trough, square, flat, or V-shaped. In some embodiments, the housing comprises a proximal sealing member, a distal sealing member, or any combination thereof. In some embodiments, the proximal sealing member and the distal sealing member comprise an elastomeric material configured to seal the housing within the ear of the subject. In some embodiments, the ultrasound transducer is electrically coupled to the one or more electric leads of the insert by the one or more wires. In some embodiments, the insert comprises a spacer structure configured to space the insert from the internal surface of the lumen of the housing. In some embodiments, the insert comprises a structure configured to releasably couple to the housing when inserted into the housing. In some embodiments, the structure comprises a groove, hole, or hook configured to snap to a structure of the housing. In some embodiments, the housing is partially or wholly vapor polished, aluminum coated, chrome coated, or any combination thereof. In some embodiments, the insert comprises an electrical coupling interface comprising an electro-mechanical structure configured to releasably couple with and be in electrically communication with a receptacle. In some embodiments, the electro-mechanical structure comprises one or more electrical pads adjacent a surface of one or more mechanical coupling interface. In some embodiments, the one or more mechanical coupling interface comprises a hook configured to couple with a clasp receptable.
In another aspect, the disclosure provides an otoscope, the otoscope comprising: a speculum and having a lumen therewithin and comprising a light conducting element, wherein a transmitted optical illumination is conducted by total internal reflection by the light conducting element, and wherein a reflected optical illumination is propagated through the lumen of the speculum; and one or more coupling portions which couple the transmitted optical illumination from a light source to the light conducting element, wherein the one or more coupling portions are shaped as a conic section. In some embodiments, the otoscope further comprises an insert, wherein the insert is configured to mechanically couple to the speculum. In some embodiments, the insert comprises a lens, an ultrasound transducer, one or more electrical leads electrically coupled to the ultrasound transducer, one or more wires electrically coupled to the one or more electrical leads and the ultrasound transducer, or any combination thereof. In some embodiments, the ultrasound transducer comprises a capacitive micromachined ultrasonic transducer. In some embodiments, the light conducting element comprises an ellipsoid shape. In some embodiments, the light conducting element is configured to be a parabolic mirror when light rays of the light source interact with the light conducting element. In some embodiments, the light conducting element comprises a launch point. In some embodiments, the light conducting element comprises at least two launch points. In some embodiments, the launch point comprises a geometry, wherein the geometry comprises: flat, circular, oval, trough, square, flat, or V-shaped. In some embodiments, the speculum comprises a proximal sealing member, a distal sealing member, or any combination thereof. In some embodiments, the proximal sealing member and the distal sealing member comprise an elastomeric material configured to seal the housing within the ear of the subject. In some embodiments, the ultrasound transducer is electrically coupled to the one or more electric leads of the insert by the one or more wires. In some embodiments, the insert comprises a spacer structure configured to space the insert from the internal surface of the lumen of the speculum. In some embodiments, the insert comprises a structure configured to releasably couple to the speculum when inserted into the speculum. In some embodiments, the structure comprises a groove, hole, or hook configured to snap to a structure of the speculum. In some embodiments, the speculum is partially or wholly vapor polished, aluminum coated, chrome coated, or any combination thereof. In some embodiments, the insert comprises an electrical coupling interface comprising an electro-mechanical structure configured to releasably couple with and be in electrical communication with a receptacle. In some embodiments, the electro-mechanical structure comprises one or more electrical pads adjacent a surface of the one or more mechanical coupling interface. In some embodiments, the one or more mechanical coupling interfaces comprise a hook configured to couple with a clasp receptable.
In another aspect, the disclosure provides a method of using an otoscope, the method comprising: directing optical illumination of a light source to one or more coupling portions, wherein the one or more coupling portions are shaped as a conic section; collimating the optical illumination using the one or more coupling portions; directing the optical illumination from the one or more coupling portions to a light conducting element, wherein the optical illumination propagates through the light conducting element by total internal reflection; and collecting reflected optical illumination from a target within a lumen of a housing, wherein the housing comprises a portion of a speculum of an otoscope. In some embodiments, the method further comprises directing pneumatic excitation toward the target. In some embodiments, the method further comprises directing ultrasound or illumination toward the target. In some embodiments, the method further comprises measuring a response of the target to the pneumatic excitation in a reflected ultrasound signal. In some embodiments, the method further comprises determining a state or condition of a subject based on the reflected optical illumination and the response.
Another aspect of the present disclosure provides a system comprising one or more computer processors and computer memory coupled thereto. The computer memory comprises machine executable code that, upon execution by the one or more computer processors, implements any of the methods above or elsewhere herein.
Additional aspects and advantages of the present disclosure will become readily apparent to those skilled in this art from the following detailed description, wherein only illustrative embodiments of the present disclosure are shown and described. As will be realized, the present disclosure is capable of other and different embodiments, and its several details are capable of modifications in various obvious respects, all without departing from the disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.
All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. To the extent publications and patents or patent applications incorporated by reference contradict the disclosure contained in the specification, the specification is intended to supersede and/or take precedence over any such contradictory material.
The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings (also “Figure”, “FIG.” and “FIGS.” herein), of which:
The devices, otoscopes, specula, and methods of use and manufacture thereof as disclosed herein may address issues related to devices for measuring optical and ultrasound information. Embodiments of the present disclosure may improve upon the delivery of light and/or collection of light from a biological membrane, which may be characterized simultaneously with ultrasound excitation. The devices, otoscopes, specula, and methods of use and manufacture thereof as disclosed herein may address difficulties in the field regarding the alignment of device for measuring reflected ultrasound signals. In some case, present disclosure addresses issues in the field of otoscopy.
For example, surface characterization using an analysis of reflected ultrasound in the presence of a pneumatic excitation may be improved if the delivery of optical illumination, pneumatic excitation, and ultrasound signal is space efficient. For example, surface characterization using an analysis of reflected ultrasound in the presence of a pneumatic excitation may be improved if the measurement of reflected ultrasound signal and reflected optical illumination is space efficient.
For example, surface characterization using an analysis of reflected ultrasound in the presence of a pneumatic excitation may be improved if the ultrasound is directed at the surface at an angle that will result in ultrasound signal being returned to the transducer. Because ultrasound excitation is not visible to an eye, particularly the eye of a device operator, alignment of the ultrasound may be non-trivial. In one solution, a light source may be directed toward the surface to allow a user to better adjust an alignment of the device. The light source may be substantially aligned with the ultrasound propagation. In an ear, a user may align a light source within an ear canal to reflect light off the tympanic membrane. A good reflection may result in a “cone of light.” However, because a user may not look directly through the center of the lens and/or because a transducer may block the reflected light, the ultrasound and the light may not be propagating in the same direction.
The devices, otoscopes, specula, and methods of use and manufacture thereof as disclosed herein may be used in combination with for example devices and methods to characterize a ductile membrane, surface, and sub-surface properties such as those described in commonly owned U.S. Patent Publication 2020/0107813, U.S. Patent Publication 2018/0310917, and U.S. Patent Publication 2017/0014053, each of which is incorporated by reference in their entireties.
The devices, otoscopes, specula, and methods of use and manufacture thereof as disclosed herein may be used to characterize several biological tissues to provide a variety of diagnostic information. A biological tissue may comprise a patient organ. A speculum may be disposed within a bodily cavity to characterize a patient tissue. A patient organ or bodily cavity may comprise for example: a muscle, a tendon, a ligament, a mouth, a tongue, a pharynx, an esophagus, a stomach, an intestine, an anus, a liver, a gallbladder, a pancreas, a nose, a larynx, a trachea, lungs, kidneys, a bladder, a urethra, a uterus, a vagina, an ovary, a testicle, a prostate, a heart, an artery, a vein, a spleen, a gland, a brain, a spinal cord, a nerve, etc., or any combination thereof to name a few.
The devices, otoscopes, specula, and methods of use and manufacture thereof as disclosed herein may be used to characterize a tympanic membrane. For example, a tympanic membrane may be characterized to determine a condition of an ear, such as acute otitis media (AOM). A characterization that an ear exhibits AOM may include detection of the presence of effusion and characterization of the type of effusion as one of serous, mucoid, purulent, or combinations of these. In AOM, the middle ear effusion (MEE) may be induced by infective agents and may be thin or serous with viral infection and thicker and purulent with bacterial infection. Accordingly, determining various properties (shape or thickness of liquid, viscosity, or and/or other mechanical properties) of a fluid adjacent a tympanic membrane may provide information which may be used to characterize a membrane and/or provide a diagnosis to a patient.
While various embodiments of the invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed.
Whenever the term “at least,” “greater than,” or “greater than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “at least,” “greater than” or “greater than or equal to” applies to each of the numerical values in that series of numerical values. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.
Whenever the term “no more than,” “less than,” or “less than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “no more than,” “less than,” or “less than or equal to” applies to each of the numerical values in that series of numerical values. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.
Certain inventive embodiments herein contemplate numerical ranges. When ranges are present, the ranges include the range endpoints. Additionally, every sub range and value within the range is present as if explicitly written out. The term “about” or “approximately” may mean within an acceptable error range for the particular value, which will depend in part on how the value is measured or determined, e.g., the limitations of the measurement system. For example, “about” may mean within 1 or more than 1 standard deviation, per the practice in the art. Alternatively, “about” may mean a range of up to 20%, up to 10%, up to 5%, or up to 1% of a given value. Where particular values are described in the application and claims, unless otherwise stated the term “about” meaning within an acceptable error range for the particular value may be assumed.
A speculum, for example, one that houses a camera module may be shaped like a conic section funnel, which, in the extreme, mimics a hyperbolic rotation. These hyperbolic funnels are often used to teach physics students about orbits and gravity because of the properties they exhibit. It may be difficult to send something through one of these funnels without a lot of swirling and friction. It may be challenging to approach the center of the funnel on a radial path of the optical axis of the funnel, which may be advantageous to avoid swirling. In the optical case, excessive swirling may result in many rays turning around and exiting at the launch surface instead of the tip, which may result in light loss.
It may be advantageous to direct the rays from the LEDs onto a radial path of the optical axis of the funnel that leads to a direct route through the funnel and therefore avoiding swirling. A method which launches the rays down the radial direction of the funnel may accomplish this goal to a certain extent. However, since an LED is an extended source there may be limits to the efficiency of this scheme. Not all rays may be controlled well enough to make it through the funnel efficiently due, for example, to the etendue properties of the source.
It may be advantageous to provide a shape that is substantially similar to a section of an ellipsoid attached to the funnel shaped speculum. Such a shape may act as a section of an elliptical mirror and direct rays along the radial lines of the speculum thus improving the coupling efficiency between the light source and rays of light exiting the speculum tip for illumination.
In some cases, the devices 200 and 600 described herein may comprise a speculum tip (207, 633), and insert (e.g., an XMC) (224, 602), as shown in
In some instances, the speculum tip (207, 633) may comprise a distal sealing member (204, 628), exit tip (202, 630), speculum conical section (206, 632), one or more light conducting elements (212, 622), a proximal sealing member (208, 626), one or more light source alignment features (227, 620), one or more launch points (214, 618) or any combination thereof, as seen in
In some cases, the light conducting elements (212, 622) may comprise a portion of an ellipsoid shape 316, as seen in
As described elsewhere herein, the light conducting element's ellipsoid shape may prevent secondary and tertiary reflections of the coupled point source or near point source in manner causing the light rays to reflect back out of the light conducting element as light rays are coupled into a conical section, e.g., as shown in
The light conducting elements (212, 622) may be adhered to, combined, molded together, or connected with the speculum conical section (206, 632) of the speculum tip. The intersection geometry between the light conducting elements and the speculum conical section may be a function of both production concerns (molding properties), and efficiency concerns. For example,
In some cases, the exit tip aperture distribution pattern may be affected by changes in the light conducting element conical section design. Changing the number of light conducting elements (i.e., petals) or the type of launch point geometry, described elsewhere herein, may change the illumination pattern at the exit tip. The examples of launch geometry and the number of petals provided herein may provide a sufficient illumination pattern while maintaining satisfactory efficiency.
In some cases, the light conducting elements (212, 622) may collimate or re-direct a light source such that the output light out of the speculum exit tip (202, 630) is at least 30% at least 40% at least 50% at least 60%, at least 70%, at least 80%, at least 90%, or at least 95% the output power of the light source coupled into the one or more launch points (214, 618). In some instances, the light source may comprise a light emitting diode, a surface light emitting diode, a super luminescent diode, a laser, a supercontinuum diode laser, pulsed laser, or any combination thereof. In some instances, the light source may comprise coupling optics between the light source and the one or more launch points (214, 618). In some cases, the coupling optics between the light source and the one or more launch points (214, 618) may comprise one or more lenses and/or index matching material between the one or more lenses and the one or more launch points (214, 618). In some cases, the one or more launch points (214, 618) may be optically coupled to the one or more light conducting elements (212, 622), the speculum conical section (206, 632), and/or the exit tip (202, 630) of the speculum tip. In some cases, the light conducting elements (212, 622) may comprise one or more light source alignment features (227, 620), where the one or more light source alignment features are configured to align placement of the light source with respect to the one or more launch points (214, 618). The one or more light source alignment features (227, 620) may protrude out and away from the surface of one or more light conducting elements.
In some cases, the one or more launch points (214, 618) may be configured to interface and/or couple a light source into the one or more light conducting elements (212, 622). In some cases, the one or more launch points (214, 618) may comprise a geometry. The geometry may comprise flat, circular, oval, trough, triangular, square, or V-shaped geometry as seen in
In some cases, the flat launch point geometry may comprise a length 700, as seen in
In some cases, the circular launch point geometry, as seen in
In some cases, the oval launch point geometry, as seen in
In some instances, the square launch point geometry, as seen in
In some cases, the trough launch point geometry, as seen in
In some cases, the V-shaped launch point geometry, as seen in
In some instances, the distal sealing member (204, 628) and/or the proximal sealing member (208, 626) may be comprised of a material that is configured to provide a seal between the device (200, 600) tip and a tubular cavity or orifice of a patient and/or subject that the speculum tip (207, 633) is inserted into. In some cases, the proximal sealing member 208 and/or the distal sealing member 204 may comprise one or more circular ring structures, as seen in
In some cases, the insert (224, 602) may comprise an ultrasound transducer (222, 614) (e.g., a cMUT), one or more wires (225, 616) in electrical communication with the ultrasound transducer (222, 614) and the one or more leads of the insert (226, 606), a lens (216, 612), one or more mechanical coupling structures (220, 604) configured to couple to the speculum tip conical section (206, 632) at one or more mechanical fastening features (624), one or more electro-mechanical structures (210, 634) configured to interact with a corresponding receptacle, one or more mechanical support structures (228, 610) or any combination thereof as can be seen in
In some cases, the one or more mechanical coupling structures (220, 604), may comprise a hook or protrusion that may to one or more mechanical fastening features (624). The one or more fastening features may comprise a corresponding feature that mates with the one or more mechanical coupling structures (220, 604) e.g., a cut out feature that a hook may snap into.
In some cases, the insert (224, 602) may comprise a lens (216, 612) coupled to the insert. In some cases, the lens may be in contact to or adjacent to the ultrasound transducer (222, 614). In some cases, the lens may be configured to focus reflected light of the light source off a biological surface and/or tissue for viewing by an operator of an otoscope fitted with the device (200, 600). In some cases, the lens may be placed proximal to the ultrasound transducer. In some instances, the lens may focus reflected light of the light source off a biological surface and/or tissue onto an image sensor, of the systems described elsewhere herein, that may convert the reflected light rays into a still image or video of the biological surface and/or tissue. In some cases, the lens may comprise an antireflective coating, where the antireflective coating transmits a first spectra and reflects a second spectra. In some instances, the first spectra may comprise the visible spectra and the second spectra may comprise an infrared spectrum.
In some instances, the one or more wires (225, 616) may be configured to transmit and/or relay electrical signals from the one or more leads (226, 606) to the ultrasound transducer (222, 614). In some cases, the one or more wires (225, 616) may connect to the one or more leads (226, 606) to the ultrasound transducer (222, 614) through wire bonding techniques.
In some cases, the device of the disclosure may comprise an ultrasound transducer (222, 614) that may electrically couple to the one or more leads via a surface mount pad of the ultrasound transducer (222, 614). In some cases, the ultrasound transducer (222, 614) may comprise a capacitive micromachined ultrasonic transducer (cMUT).
The present disclosure provides methods of using devices and related speculum tips, described elsewhere herein. In some cases, the method comprises the use of an otoscope with a speculum tip, as shown in
The present disclosure provides computer systems that are programmed to implement methods of the disclosure.
The computer system 1301 includes a central processing unit (CPU, also “processor” and “computer processor” herein) 1305, which can be a single core or multi core processor, or a plurality of processors for parallel processing. The computer system 1301 also includes memory or memory location 1310 (e.g., random-access memory, read-only memory, flash memory), electronic storage unit 1315 (e.g., hard disk), communication interface 1320 (e.g., network adapter) for communicating with one or more other systems, and peripheral devices 1325, such as cache, other memory, data storage and/or electronic display adapters. The memory 1310, storage unit 1315, interface 1320 and peripheral devices 1325 are in communication with the CPU 1305 through a communication bus (solid lines), such as a motherboard. The storage unit 1315 can be a data storage unit (or data repository) for storing data. The computer system 1301 can be operatively coupled to a computer network (“network”) 1330 with the aid of the communication interface 1320. The network 1330 can be the Internet, an internet and/or extranet, or an intranet and/or extranet that is in communication with the Internet. The network 1330 in some cases is a telecommunication and/or data network. The network 1330 can include one or more computer servers, which can enable distributed computing, such as cloud computing. The network 1330, in some cases with the aid of the computer system 1301, can implement a peer-to-peer network, which may enable devices coupled to the computer system 1301 to behave as a client or a server.
The CPU 1305 can execute a sequence of machine-readable instructions, which can be embodied in a program or software. The instructions may be stored in a memory location, such as the memory 1310. The instructions can be directed to the CPU 1305, which can subsequently program or otherwise configure the CPU 1305 to implement methods of the present disclosure. Examples of operations performed by the CPU 1305 can include fetch, decode, execute, and writeback.
The CPU 1305 can be part of a circuit, such as an integrated circuit. One or more other components of the system 1301 can be included in the circuit. In some cases, the circuit is an application specific integrated circuit (ASIC).
The storage unit 1315 can store files, such as drivers, libraries, and saved programs. The storage unit 1315 can store user data, e.g., user preferences and user programs. The computer system 1301 in some cases can include one or more additional data storage units that are external to the computer system 1301, such as located on a remote server that is in communication with the computer system 1301 through an intranet or the Internet.
The computer system 1301 can communicate with one or more remote computer systems through the network 1330. For instance, the computer system 1301 can communicate with a remote computer system of a user. Examples of remote computer systems include personal computers (e.g., portable PC), slate or tablet PC's (e.g., Apple® iPad, Samsung® Galaxy Tab), telephones, Smart phones (e.g., Apple® iPhone, Android-enabled device, Blackberry®), or personal digital assistants. The user can access the computer system 1301 via the network 1330.
Methods as described herein can be implemented by way of machine (e.g., computer processor) executable code stored on an electronic storage location of the computer system 1301, such as, for example, on the memory 1310 or electronic storage unit 1315. The machine executable or machine-readable code can be provided in the form of software. During use, the code can be executed by the processor 1305. In some cases, the code can be retrieved from the storage unit 1315 and stored on the memory 1310 for ready access by the processor 1305. In some situations, the electronic storage unit 1315 can be precluded, and machine-executable instructions are stored on memory 1310.
The code can be pre-compiled and configured for use with a machine having a processer adapted to execute the code or can be compiled during runtime. The code can be supplied in a programming language that can be selected to enable the code to execute in a pre-compiled or as-compiled fashion.
Aspects of the systems and methods provided herein, such as the computer system 1301, can be embodied in programming. Various aspects of the technology may be thought of as “products” or “articles of manufacture” typically in the form of machine (or processor) executable code and/or associated data that is carried on or embodied in a type of machine readable medium. Machine-executable code can be stored on an electronic storage unit, such as memory (e.g., read-only memory, random-access memory, flash memory) or a hard disk. “Storage” type media can include any or all of the tangible memory of the computers, processors or the like, or associated modules thereof, such as various semiconductor memories, tape drives, disk drives and the like, which may provide non-transitory storage at any time for the software programming. All or portions of the software may at times be communicated through the Internet or various other telecommunication networks. Such communications, for example, may enable loading of the software from one computer or processor into another, for example, from a management server or host computer into the computer platform of an application server. Thus, another type of media that may bear the software elements includes optical, electrical, and electromagnetic waves, such as used across physical interfaces between local devices, through wired and optical landline networks and over various air-links. The physical elements that carry such waves, such as wired or wireless links, optical links, or the like, also may be considered as media bearing the software. As used herein, unless restricted to non-transitory, tangible “storage” media, terms such as computer or machine “readable medium” refer to any medium that participates in providing instructions to a processor for execution.
Hence, a machine readable medium, such as computer-executable code, may take many forms, including but not limited to, a tangible storage medium, a carrier wave medium or physical transmission medium. Non-volatile storage media include, for example, optical or magnetic disks, such as any of the storage devices in any computer(s) or the like, such as may be used to implement the databases, etc. shown in the drawings. Volatile storage media include dynamic memory, such as main memory of such a computer platform. Tangible transmission media include coaxial cables; copper wire and fiber optics, including the wires that comprise a bus within a computer system. Carrier-wave transmission media may take the form of electric or electromagnetic signals, or acoustic or light waves such as those generated during radio frequency (RF) and infrared (IR) data communications. Common forms of computer-readable media therefore include for example: a floppy disk, a flexible disk, hard disk, magnetic tape, any other magnetic medium, a CD-ROM, DVD or DVD-ROM, any other optical medium, punch cards paper tape, any other physical storage medium with patterns of holes, a RAM, a ROM, a PROM and EPROM, a FLASH-EPROM, any other memory chip or cartridge, a carrier wave transporting data or instructions, cables or links transporting such a carrier wave, or any other medium from which a computer may read programming code and/or data. Many of these forms of computer readable media may be involved in carrying one or more sequences of one or more instructions to a processor for execution.
The computer system 1301 can include or be in communication with an electronic display 1335 that comprises a user interface (UI) 1340 for providing, for example, providing alignment information, providing diagnostic information, etc. Examples of UI's include, without limitation, a graphical user interface (GUI) i.e., a monitor screen or device display, and web-based user interface.
Methods and systems of the present disclosure can be implemented by way of one or more algorithms. An algorithm can be implemented by way of software upon execution by the central processing unit 1305. The algorithm can, for example, implement a method of characterizing a tympanic membrane.
Numbered embodiment 1 comprises a speculum operable to be disposed within an ear of a subject, the speculum comprising: a housing comprising a light conducting element, wherein a transmitted optical illumination is conducted by total internal reflection via the light conducting element, wherein the housing has a lumen therewithin, and wherein the housing is configured to allow a reflected optical illumination to propagate through the lumen; and one or more coupling portions which couple the transmitted optical illumination from a light source to the light conducting element, wherein the one or more coupling portions are shaped as a conic section. Numbered embodiment 2 comprises the device of embodiment 1 further comprising an insert, wherein the insert is configured to be mechanically coupled to the housing. Numbered embodiment 3 comprises the device of embodiment 2, wherein the insert comprises a lens, an ultrasound transducer, one or more electrical leads electrically coupled to the ultrasound transducer, one or more wires electrically coupled to the one or more electrical leads and the ultrasound transducer, or any combination thereof. Numbered embodiment 4 comprises the device of embodiment 3 wherein the ultrasound transducer comprises a capacitive micromachined ultrasonic transducer. Numbered embodiment 5 comprises the device of any one of embodiments 1 to 4, wherein the light conducting element comprises an ellipsoid shape. Numbered embodiment 6 comprises the device of any one of embodiments 1 to 5, wherein the light conducting element is configured to be a parabolic mirror when light rays of the light source interact with the light conducting element. Numbered embodiment 7 comprises the device of any one of embodiments 1 to 6, wherein the light conducting element comprises a launch point. Numbered embodiment 8 comprises the device of any one of embodiments 1 to 6, wherein the light conducting element comprises one or more launch points. Numbered embodiment 9 comprises the device of embodiment 7 or 8, wherein the launch points comprise a geometry, wherein the geometry comprises: flat, round, oval, trough, square, or V-shaped. Numbered embodiment 10 comprises the device of embodiment 1, wherein the housing comprises a proximal sealing member, a distal sealing member, or any combination thereof. Numbered embodiment 11 comprises the device of any one of embodiments 1 to 10, wherein the proximal sealing member and the distal sealing member comprise an elastomeric material configured to seal the housing within the ear of the subject. Numbered embodiment 12 comprises the device of embodiment 3, wherein the ultrasound transducer is electrically coupled to the one or more electric leads of the insert by the one or more wires. Numbered embodiment 13 comprises the device as in embodiment 3 or 12, wherein the insert comprises a spacer structure configured to space the insert from the internal surface of the lumen of the housing. Numbered embodiment 14 comprises the device as in embodiments 3, 12, or 13, wherein the insert comprises a structure configured to releasably couple to the housing when inserted into the housing. Numbered embodiment 15 comprises the device of embodiment 14, wherein the structure comprises a groove, hole, or hook configured to snap to a structure of the housing. Numbered embodiment 16 comprises the device of any one of embodiments 1 to 14, wherein the housing is partially or wholly vapor polished, aluminum coated, chrome coated, or any combination thereof. Numbered embodiment 17 comprises the device of any one of embodiments 1 to 16, wherein the insert comprises an electrical coupling interface comprising an electro-mechanical structure configured to releasably couple with and be in electrically communication with a receptacle. Numbered embodiment 18 comprises the device of embodiments 17, wherein the electro-mechanical structure comprises one or more electrical pads adjacent a surface of one or more mechanical coupling interfaces. Numbered embodiment 19 comprises the device of embodiment 18, wherein the one or more mechanical coupling interfaces comprises a hook configured to couple with a clasp receptable.
Numbered embodiment 20 comprises an otoscope, the otoscope comprising: a speculum and having a lumen therewithin and comprising a light conducting element, wherein a transmitted optical illumination is conducted by total internal reflection by the light conducting element, and wherein a reflected optical illumination is propagated through the lumen of the speculum; and one or more coupling portions which couple the transmitted optical illumination from a light source to the light conducting element, wherein the one or more coupling portions are shaped as a conic section. Numbered embodiment 21 comprises the device of embodiment 20, further comprising an insert, wherein the insert is configured to mechanically couple to the speculum. Numbered embodiment 22 comprises the device of embodiment 21, wherein the insert comprises a lens, an ultrasound transducer, one or more electrical leads electrically coupled to the ultrasound transducer, one or more wires electrically coupled to the one or more electrical leads and the ultrasound transducer, or any combination thereof. Numbered embodiment 23 comprises the device of embodiment 22, wherein the ultrasound transducer comprises a capacitive micromachined ultrasonic transducer. Numbered embodiment 24 comprises the device of any one of embodiments 20 to 23, wherein said light conducting element comprises an ellipsoid shape. Numbered embodiment 25 comprises the device of any one of embodiments 20 to 24, wherein the light conducting element is configured to be a parabolic mirror when light rays of the light source interact with the light conducting element. Numbered embodiment 26 comprises the device of any one of embodiments 20 to 25, wherein the light conducting element comprises a launch point. Numbered embodiment 27 comprises the device of any one of embodiments 20 to 25, wherein the light conducting element comprises at least two launch points. Numbered embodiment 28 comprises the device as in embodiment 26 or 27, wherein the launch point comprises a geometry, wherein the geometry comprises: flat, round, oval, trough, square, or V-shaped. Numbered embodiment 29 comprises the device of any one of embodiments 20 to 28, wherein the speculum comprises a proximal sealing member, a distal sealing member, or any combination thereof. Numbered embodiment 30 comprises the device of embodiment 29, wherein the proximal sealing member and the distal sealing member comprise an elastomeric material configured to seal the housing within the ear of the subject. Numbered embodiment 31 comprises the device of any one of embodiments 22 to 27, wherein the ultrasound transducer is electrically coupled to the one or more electric leads of the insert by the one or more wires. Numbered embodiment 32 comprises the device of any one of embodiments 22 to 27 or 31, wherein the insert comprises a spacer structure configured to space the insert from the internal surface of the lumen of the speculum. Numbered embodiment 33 comprises the device of any one embodiments 22 to 27, 31, or 32, wherein the insert comprises a structure configured to releasably couple to the speculum when inserted into the speculum. Number embodiment 34 comprises the device of embodiment 33, wherein the structure comprises a groove, hole, or hook configured to snap to a structure of the speculum. Numbered embodiment 35 comprises the device of any one of embodiments 20 to 34, wherein the speculum is partially or wholly vapor polished, aluminum coated, chrome coated, or any combination thereof. Numbered embodiment 36 comprises the device of any one of embodiments 22 to 27 or 31 to 33, wherein the insert comprises an electrical coupling interface comprising an electro-mechanical structure configured to releasably couple with and be in electrically communication with a receptacle. Numbered embodiment 37 comprises the device of embodiment 36, wherein the electro-mechanical structure comprises one or more electrical pads adjacent a surface of one or more mechanical coupling interface. Numbered embodiment 38 comprises the device of embodiment 37, wherein the one or more mechanical coupling interface comprises a hook configured to couple with a clasp receptable.
Numbered embodiment 39 comprises a method of using an otoscope, the method comprising: directing optical illumination of a light source to one or more coupling portions, wherein the one or more coupling portions are shaped as a conic section; collimating the optical illumination using the one or more coupling portions; directing the optical illumination from the one or more coupling portions to a light conducting element, wherein the optical illumination propagates through the light conducting element by total internal reflection; and collecting reflected optical illumination from a target within a lumen of a housing, wherein the housing comprises a portion of a speculum of an otoscope. Numbered embodiment 40 comprises the method of embodiment 39, further comprising directing pneumatic excitation toward the target. Numbered embodiment 41 comprises the method as in embodiment 39 or 40, further comprising directing ultrasound or illumination toward the target. Numbered embodiment 42 comprises the method of embodiment 40, further comprising measuring a response of the target to the pneumatic excitation in a reflected ultrasound signal. Numbered embodiment 43 comprises the method of any one of embodiments 39 to 42, further comprising determining a state or condition of a subject based on the reflected optical illumination and the response.
Ray tracing analysis of light coupling from a light source into and exiting the ellipsoid (i.e., “petal”) light conducting structure was conducted using Zemax, as seen in
Optical power transmission was compared between a speculum tip with a conical section (
An experiment showing visual brightness variation between speculum tips C0 508, and the conical section with the one or more light conducting elements (“petal”) 504 may be seen in
Speculum tips were hand polished (
The effect of an adjacent biologic surface held against an outer surface of the speculum tip on measured absolute irradiance (μW/cm2) and % irradiance relative to baseline (μW/cm2) was determined, as shown
Illumination performance between vapor polished
Each speculum tip was placed into an experimental illumination receptacle as outlined in Example 5 to prevent stray light from adding noise to the illumination measurement. Illumination measurements (
Simulated ray tracing and optical illumination transmission was completed for various launch point geometries, described elsewhere herein, shown in
In-ear videos were taken using illuminated speculum tips where the speculum tips were chrome coated (
A Hawkeye Pro Super Slim borescope and iPhone 12 camera were used to capture videos of an illuminated tympanic membrane of a subject as the drive current to the illumination LEDs was varied. The iPhone 12 camera exposure settings were locked to the following set points: ISO 100, EV 0, Color Temp 4000K, Shutter speed 1/60 sec, manual focus 50. The Hawkeye focus was adjusted to give the sharpest image while the live in-ear video is being recorded. Representative images from each of the experimental conditions (i.e., varying current light source supply values) are shown in
From the images shown in
Turning to
While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. It is not intended that the invention be limited by the specific examples provided within the specification. While the invention has been described with reference to the aforementioned specification, the descriptions and illustrations of the embodiments herein are not meant to be construed in a limiting sense. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. Furthermore, it shall be understood that all aspects of the invention are not limited to the specific depictions, configurations or relative proportions set forth herein which depend upon a variety of conditions and variables. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is therefore contemplated that the invention shall also cover any such alternatives, modifications, variations, or equivalents. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.
Although the above steps show each of the methods in accordance with embodiments, a person of ordinary skill in the art will recognize many variations based on the teaching described herein. The steps may be completed in a different order. Steps may be added or omitted. Some of the steps may comprise sub-steps. Many of the steps may be repeated as often as beneficial.
One or more of the steps of each of the methods may be performed with circuitry as described herein, for example, one or more of the processor or logic circuitry such as programmable array logic for a field programmable gate array. The circuitry may be programmed to provide one or more of the steps of each of the methods, and the program may comprise program instructions stored on a computer readable memory or programmed steps of the logic circuitry such as the programmable array logic or the field programmable gate array, for example.
This application is a continuation of PCT Application No. PCT/US2022/35003, filed Jun. 24, 2022, which claims benefit of U.S. Provisional Patent Application No. 63/214,938 filed Jun. 25, 2021, which is entirely incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63214938 | Jun 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US22/35003 | Jun 2022 | US |
| Child | 18476263 | US |
