Patent Grant
8840558
The present application relates to physically fitting hearing assistance devices and in particular to mathematically characterizing ear canal geometry for physically fitting hearing assistance devices.
Hearing instrument manufacturers have adopted laser scanning of traditional impressions as the method of obtaining mathematical representations of the ear canal geometry. A dispenser will acquire the impression from the patient and mail the impression directly to the manufacturer. Unfortunately, the impression can become distorted during the mailing process due to uncured material and excessive temperatures in the delivery trucks; the result is an inaccurate impression of the patient's physiology thereby leading to a hearing instrument that does not fit properly. It is common practice for the dispenser to acquire another impression from the patient and return the hearing instrument for rework.
In some instances, it is common for the hearing instrument to pop out of the patient's ear during chewing or other jaw motion. Since the impression is obtained in a “static” condition within the ear canal, geometry changes of the ear canal during chewing can cause the hearing instrument to jostle and pop out. In order to mitigate these occurrences, it may be advantageous to acquire two different impressions: one with the jaw closed and one with the jaw open. The final earmold for the hearing instrument can be extrapolated as an average from the two impressions, thereby reducing the potential for “popout”.
Depending on the cure rate of the polymeric material used for ear impressions, the process can typically take from ten to fifteen minutes per pair of impressions, not to mention administrative time in preparing, shipping, and receiving the impressions. It would be advantageous to have a process that acquired the mathematical representation at the dispenser's office in less time and forwarded the data directly to the manufacturer electronically to save time and expense.
The present subject matter provides apparatus and methods for physically fitting a hearing assistance device, including mathematically characterizing a person's ear canal. The apparatus includes an expandable balloon for positioning in the ear canal, the balloon including a hollow interior channel. A flexible catheter extends through the interior portion of the balloon, and the flexible catheter includes a track. A platform is movably coupled to the track. An ultrasonic transducer and a microelectromechanical systems (MEMS) sensor are coupled to the platform. The ultrasonic transducer scans the ear canal and the MEMS sensor senses motion and position of the transducer. According to various embodiments, a mathematical representation of the ear canal is adapted to be computed using information from the transducer and sensor.
This summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details about the present subject matter are found in the detailed description. The scope of the present invention is defined by the appended claims and their equivalents.
The following detailed description of the present subject matter refers to subject matter in the accompanying drawings which show specific aspects and embodiments in which the present subject matter may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the present subject matter. References to “an”, “one”, or “various” embodiments in this disclosure are not necessarily to the same embodiment, and such references contemplate more than one embodiment. The following detailed description is demonstrative and not to be taken in a limiting sense. The scope of the present subject matter is defined by the appended claims, along with the full scope of legal equivalents to which such claims are entitled.
Various embodiments of the present subject matter utilize 1) an ultrasonic transducer system for the purpose of imaging the physiology of the ear canal, 2) a replaceable, fluid-filled medical balloon catheter for the purpose of expanding against the concha and ear canal walls so as to mechanically couple the transducer system to the skin, and 3) a mechanical system to traverse the transducer system within the ear canal in order to image and mathematically compute its shape.
Modem techniques for obtaining a person's ear canal geometry utilize highly-compliant polymeric materials that are injected into a person's ear canal with a syringe. After the material cures, it is pulled from the ear thereby giving a three dimensional impression of the ear canal geometry. Traditionally, the impression is cast in a silicone investment and removed, thereby leaving a representation of the original ear canal. In a procedure that is similar to the traditional casting of a bell, a custom earmold is created by pouring resins into the investment and allowing them to cure into plastic. Although this technique gives a reasonably accurate representation of the ear canal geometry, it does not yield any mathematical information about its shape. A mathematical representation would be valuable for an automated, digital shell making procedure such as stereo lithography, etc.
Recently, laser technology has been used to scan the features of the impression into a mathematical format such as “point cloud” data. These data are used to create a custom shell with automated, digital shell making processes. Unfortunately, the inconvenience of taking a person's ear impression remains the first step in this procedure.
In an effort to preclude the need to “shoot” a person's impression with a syringe of polymeric material, various patents have been filed which use ultrasonic and/or optical devices located on the end of a straight wand. The wand is inserted into the ear canal, and the device scans the geometry. If the device is based on an ultrasonic scanner, the ear canal must be filled with a saline-like fluid thereby making the process inconvenient, messy, and impractical. If the device is based on an optical scanner, complicated mirrors and positioning devices are needed to rotate and control the optical light beam. If the beam is scattered by hair within the ear canal, imaging precision is degraded. In addition, getting useful information beyond the first bend of the ear canal is difficult with a straight wand.
A removable, thin-walled, highly-compliant, elastomeric balloon is pre-formed to fit the physiology of a nominal ear canal and concha. In various embodiments, the physiology of the general population can be characterized with three different pre-formed balloons. The removable balloon is pre-formed with a central, cylindrical, hollow channel, and can be expanded to fit the patient's physiology snugly. The channel contains a conduit for air-pressure relief, a conduit for expanding the balloon with saline or gel, a flexible track and mechanism to position a movable platform, and an ultrasonic transducer probe fixed to the platform. The probe operates in pulse/echo mode and scans the ear canal as the platform is translated and/or rotated down the flexible track. In various embodiments, the transducer system also contains a three-axis microelectromechanical systems (MEMS) gyrator or MEMS accelerator sensor that is used to compute the rate at which the platform is translated and/or rotated. Since the rate at which the platform is translated and/or rotated is known, signal processing can be performed on the acquired ultrasonic and MEMS signal to reconstruct a mathematical representation of the ear canal, much the same way ultrasound is used to image human features inside the human body.
The present subject matter includes a method for scanning and obtaining a mathematical characterization of a person's ear canal geometry, in various embodiments. Various embodiments include a medical balloon that expands with saline within a person's ear canal while relieving internal air pressure to protect the tympanic membrane. A transducer probe transmits and receives ultrasonic acoustical energy within the expanded medical catheter and saline-filled balloon, in an embodiment. Various embodiments include a mechanism that transverses and/or rotates the ultrasonic probe at various locations within the medical catheter and balloon. A method is provided for processing the echoes from the ultrasonic probe and yielding a point cloud mathematical representation of the ear canal geometry, in various embodiments.
This application is intended to cover adaptations or variations of the present subject matter. It is to be understood that the above description is intended to be illustrative, and not restrictive. Thus, the scope of the present subject matter is determined by the appended claims and their legal equivalents.
The present application claims the benefit under 35 U.S.C. 119(e) of U.S. Provisional Patent Application Ser. No. 61/059,025, filed Jun. 5, 2008, which is incorporated herein by reference in its entirety.
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