Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10952601-B2
Publication Date
2021-03-23
Expiration Date
Abstract
Provided herein are systems, methods, and designs of speculum tips for pneumatic otoscopy. A speculum tip is disclosed and generally comprises: a cylindrical configuration including a narrow distal tip region longitudinally extending from a larger proximal region.
Core Innovation
The pneumatic otoscopy speculum tip includes a cylindrical configuration having a narrow distal tip region extending longitudinally from a larger proximal region. A central shaft lumen is coaxially disposed within the distal tip region and generates a toroidal vortex, and a distal end of the central shaft lumen includes a distal opening from which the toroidal vortex travels to displace a membrane.
The proximal region includes a proximal opening operably coupled with a proximal lumen coaxially disposed within the proximal region to receive a pulse of fluid. The speculum tip further includes a proximal air escape outlet and a distal air escape inlet fluidly coupled with an air passageway therebetween, such that the speculum tip prevents sealing with the ear canal.
The air passageway coaxially surrounds the central shaft lumen by a plurality of air passageways, thereby directing air escape while allowing the toroidal vortex to exit the distal opening. The disclosed approach is positioned to improve pneumatic otoscopy by displacing the tympanic membrane without requiring an ear-canal pressure seal, and the document describes structural variants including constant, expanding, focusing, or concentric vortex generation, flanged distal designs, and a dual lumen, double-concentric toroidal vortex.
Documented evaluation includes synthetic eardrum tests, comparison versus standard and SofSeal specula using a Life/form ear model and OCT imaging, visualization and velocity measurements of vortex rings, and automated analysis to reduce user variability, including video intensity-based tympanic membrane deflection estimation and OCT validation.
Claims Coverage
The document includes two independent claims that cover a speculum tip configured to generate a toroidal vortex while preventing ear-canal sealing, and a method that generates such a toroidal vortex to displace a membrane, prevents ear-canal pressure seal, and measures membrane displacement. Across these independent claims, the inventive coverage centers on toroidal vortex generation through a central shaft lumen, membrane displacement via a distal opening, and an air-escape arrangement to prevent sealing with the ear canal.
Toroidal vortex speculum tip with central shaft lumen and distal opening
A speculum tip includes a cylindrical configuration with a narrow distal tip region extending from a larger proximal region, where a central shaft lumen coaxially disposed within the distal tip region generates a toroidal vortex, and a distal opening at a distal end of the central shaft lumen from which the toroidal vortex travels to displace a membrane.
Air escape arrangement to prevent ear canal sealing
The speculum tip includes a proximal air escape outlet and a distal air escape inlet fluidly coupled with an air passageway therebetween to prevent the speculum tip from sealing with the ear canal, where the air passageway coaxially surrounds the central shaft lumen by a plurality of air passageways.
Method of generating toroidal vortex while preventing pressure seal and displacing a membrane
A method of generating a toroidal vortex for a speculum tip includes generating a toroidal vortex through a cylindrical configuration with a narrow distal tip region from a larger proximal region, passing a pulse of fluid through a generally central shaft lumen coaxially disposed within the distal tip region and a distal opening at a distal end of the central shaft lumen, preventing a seal with the ear canal by coupling fluid to a proximal air escape outlet and a distal air escape inlet fluidly coupled with an air passageway therebetween, and displacing a membrane by the toroidal vortex exiting the distal opening without the requirement of a pressure seal of the ear canal.
Measuring membrane displacement
The method further includes measuring the displacement of the membrane.
Overall, the independent claims require toroidal vortex generation through a coaxial central shaft lumen with a distal opening that displaces a membrane, together with a proximal and distal air-escape pathway to prevent sealing with the ear canal, and they include measuring the resulting membrane displacement.
Stated Advantages
Displaces the tympanic membrane without requiring an ear-canal pressure seal.
Produces stronger and more consistent tympanic membrane deflection when using the disclosed speculum tip, as reported in the document.
Provides seal-less performance validated by OCT, and includes safety considerations for seal-failure scenarios.
Documented Applications
Diagnosing otitis media using a toroidal vortex that displaces the tympanic membrane.
Imaging the tympanic membrane using Optical Coherence Tomography (OCT).
Video pneumatic otoscopy evaluation using a Life/form ear model and automated video intensity-based tympanic membrane deflection estimation.
Vortex ring visualization and velocity measurements to assess the toroidal vortex behavior.
Synthetic eardrum testing to evaluate tympanic membrane deflection.
Interested in licensing this patent?