Patent Publication Number: US-8983084-B2

Title: Modular wireless auditory test instrument with intelligent transducers

Description:
RELATED APPLICATION DATA 
     This application is a continuation of U.S. patent application Ser. No. 10/394,785, filed on Mar. 21, 2003, pending, the entire disclosure of which is expressly incorporated by reference herein. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to auditory test instruments and, more particularly, to portable, wireless auditory test instruments. 
     BACKGROUND OF THE INVENTION 
     Auditory test instruments are generally designed to be mounted to, or maintained on, a desktop. Such instruments often include a display, thus allowing the user to configure the instrument, set the test procedure and/or view the test results. A printer may also be included, thus allowing a hard copy of the test results to be printed. The instrument may also be capable of being connected, for example via an RS-232 connection, to a network, external computer or printer. Examples of such auditory test instruments are those manufactured by GN Otometrics under the Danplex, Madsen, Rastronics, Hortmann and ICS Medical brands. 
     Although the prior art auditory test instruments perform well, there are several disadvantages associated with them, primarily due to their size. First, as they are somewhat difficult to move from location to location, a single office complex may require multiple instruments, one per testing facility (e.g., one for each examination room). If one of the instruments malfunctions, or if the office complex is trying to minimize costs by limiting the number of instruments per complex, the instrument either has to be physically moved between examination rooms or the patients have to be screened and/or diagnosed in a single room, either way limiting the number of patients that can be screened and/or diagnosed within a given time period. Second, these instruments offer limited portability, thus making it difficult to perform tests outside of the facility in which they are normally used, for example at a hospital, patient&#39;s home, etc. Third, the instrument must be located near a suitable power source. Fourth, in order to use the instrument with a separate computer and/or printer, the instrument must be located near the computer and/or printer, or near a suitable network connection. 
     In addition to the afore-mentioned disadvantages, the previous auditory test instruments are specialized, thus offering no patient and/or office management tools. Accordingly, there is a need for a test instrument that overcomes the disadvantages of the previous test instruments while offering expanded capabilities. The present invention provides such a device. 
     SUMMARY OF THE INVENTION 
     The present invention provides a method and apparatus for performing a variety of auditory tests utilizing a hand-held, portable, wireless testing device. Within the device is a diagnostic subsystem which is used to implement selected tests as well as analyze the results of the selected tests. Although the diagnostic subsystem can be fully integrated into the device, preferably it is modular in design, thus allowing the subsystem to be easily replaced as needed to perform system upgrades, testing suite changes, or simple repairs. 
     In order to perform a specific test, one or more probes are attached to the device, either directly or via a flexible cable. Preferably the probe(s) is an intelligent probe that is capable of communicating data other than stimulus signals and response data. Examples of data that can be communicated with the intelligent probe include calibration data, configuration data, and operational information. 
     The device of the invention includes at least one processor, storage means (e.g., volatile and/or non-volatile memory), user input means and display means, thus allowing the device to process and store instructions as well as process, store and display data. Additionally, in at least one embodiment the processor, storage means, user input means and display means arc used to provide the user with a means of interacting with a data bank. The data bank can be used to store test protocols, instrument configuration files, patient profiles, previous test data, appointment schedules, patient contact information, employee information, patient payment histories, office invoices, etc. 
     Another subsystem of the device is a wireless networking subsystem that allows the device to communicate with other, similarly enabled, devices within the system&#39;s range. Examples of devices and systems that can be enabled and used with the invention are printers, facsimile devices, computers, cellular telephones, personal digital assistants (i.e., PDAs), and LAN systems. Accordingly, the user is able to transmit data, print data, connect to a network, obtain device configuration updates, etc. In at least one embodiment, the wireless networking subsystem also allows the user to send and receive patient and office updates, such as appointment reminders, scheduling changes, etc. 
     A further understanding of the nature and advantages of the present invention may be realized by reference to the remaining portions of the specification and the drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a block diagram of a wireless test instrument in accordance with one embodiment of the invention; 
         FIG. 2  is a perspective view of a preferred embodiment of the invention; 
         FIG. 3  is a side view of the instrument system shown in  FIG. 2 ; 
         FIG. 4  is a cross-sectional view of the instrument system shown in  FIG. 2 ; 
         FIG. 5  illustrates a controller/interface portion of a preferred embodiment of the invention; 
         FIG. 6  illustrates an analog input portion of a preferred embodiment of the invention; 
         FIG. 7  illustrates an analog output portion of a preferred embodiment of the invention; 
         FIGS. 8A-C  illustrate a pressure subsystem portion of a preferred embodiment of the invention; and 
         FIG. 9  illustrates a power subsystem portion of a preferred embodiment of the invention. 
     
    
    
     DESCRIPTION OF THE SPECIFIC EMBODIMENTS 
       FIG. 1  is a block diagram of a wireless auditory test instrument  100  in accordance with one embodiment of the invention. Instrument  100  is designed to be completely portable and preferably small enough and light enough to easily hold in one hand. Given the requirements for portability, instrument  100  includes an internal power supply  101 . Power supply  101  can utilize replaceable batteries or rechargeable batteries. If rechargeable batteries are used, they can either be recharged by removal and insertion into a separate battery charger, charged using an internally housed charging circuit temporarily coupled to an external power source, or, as in a preferred embodiment, recharged while housed within instrument  100  using an external charging circuit/unit  103 . Although external charging circuit/unit  103  can utilize contacts to electrically couple to internal power supply  101 , preferably a contactless method of coupling to internal power supply  101  is used. As such methods are well known in the art, further description of the charging circuit/unit  103  is not provided herein. 
     Within instrument  100  is a diagnostic subsystem  105  which can be configured for either screening or diagnostic testing. As will be later described in detail, diagnostic subsystem  105  is configurable to perform one or more of a variety of audiometric tests as well as to gather response data. It will be appreciated that diagnostic subsystem  105  is not necessarily a specific module, rather it is representative of the diagnostic capabilities incorporated into instrument  100 . Accordingly, the inventors have conceived of an instrument  100  that can utilize any of a variety of multiple, preferably interchangeable, diagnostic subsystems, thus allowing the end user to select the desired testing capabilities. Alternately, a diagnostic subsystem  105  can be used within instrument  100  that can be configured to perform one or more tests selected from a variety of tests. 
     Instrument  100  includes a processor  107 . As used herein, the term processor refers to processors, digital signal processors (DSPs), microprocessors, CPUs, application specific integrated circuits (ASICs), etc. Processor  107  is used to implement tests, analyze test results, and, in general, manage instrument  100 &#39;s operation. It will be appreciated that instrument  100  can utilize a single processor or multiple processors. For example, although  FIG. 1  shows a single processor  107  separate from diagnostic subsystem  105 , it is understood that diagnostic subsystem can also include a separate processor. Alternately, instrument  100  can utilize one or more processors that are embedded in diagnostic subsystem  105 . Accordingly it will be understood that processor  107  in  FIG. 1  is only representative of the processing capabilities included in instrument  100 . 
     A user interface  109  provides the user of instrument  100  with a means of entering commands, thus allowing test parameters to be input, testing to be initiated, test results to be analyzed and/or reviewed, etc. User interface  109  also provides a means by which the user can access other features of instrument  100  (e.g., office management tools, patient management tools, data storage, patient histories, etc.) as well as modify the functionality of instrument  100 . User interface  109  includes an input means  111  and a display means  113 . 
     Integrated into instrument  100  is a memory  115 . Memory  115  is used to store user preferences in general and test parameters in particular. Preferably memory  115  is also used to store test data. In addition, memory  115  can be used to store patient information (e.g., test histories), office management data (e.g., appointments), and communication protocols with wirelessly connected devices. Preferably memory  115  is comprised of both non-volatile memory (e.g., ROM) and volatile memory (e.g., RAM). 
     Coupled to instrument  100  is a probe  117 . Preferably probe  117  is coupled to instrument  100  by a flexible cable  119 . Alternately, probe  117  can be coupled directly to the housing of instrument  100 . Regardless of whether probe  117  is coupled via cable  119  or integrated directly into the instrument&#39;s housing, preferably it is easily detached and replaced with other probes. It will be appreciated that probe  117  is only representative of a probe in general and that, in fact, any of a variety of probe types and configurations can be used with the preferred embodiment of the invention. Additionally, probe  117  may be comprised of a single probe or of multiple probes. 
     In order to provide instrument  100  with the desired functionality, it includes a short range wireless networking subsystem  121 . Wireless networking subsystem  121  allows instrument  100  to communicate with other similarly enabled devices that are within the system&#39;s range. Examples of such devices include computers  123 , printers  124 , and networks  125 . 
       FIGS. 2-4  illustrate a preferred embodiment of the invention.  FIG. 2  is a perspective view of an instrument system  200  while  FIG. 3  is a side view of the same instrument system. As shown, instrument system  200  is comprised of portable test instrument  201  along with a variety of accessories including a probe  203 , a probe holder  205 , and a charging unit  207 . Charging unit  207  includes a cradle portion  209  that aids in holding test instrument  201  within the charging unit. Charging unit  207  can be coupled to a desk stand  211 , a wall mount (not shown), or used without a stand. 
       FIG. 4  is a cross-sectional view of instrument system  200 . In addition to the previously identified components, this view further shows the main circuit board  401 , the analog circuit board  403 , pump  405  along with pump motor  407 , charger  207  along with charger dorn  409  and battery chamber  410 , keypad  411 , scroll wheel  413  and organic LED display  415 . 
       FIGS. 5-9  illustrate portions of a preferred embodiment of the invention. Specifically, these figures illustrate the controller/interface, analog input, analog output, pressure subsystem and power subsystem, respectively. As these figures only represent portions of an embodiment, and as there are countless embodiments of the present invention, these figures will not be described in detail herein. 
     Further description of some of the principal subsystems of instrument  100  will now be provided. It is understood that such subsystems can be used with instrument  100  regardless of the instrument&#39;s housing. For example, such subsystems arc applicable to the preferred embodiment shown in  FIGS. 2 and 3 . 
     Diagnostic Subsystem 
     Diagnostic subsystem  105 , in conjunction with probe  117 , provides the means to test the desired auditory function as well as gather the resultant response data. Preferably subsystem  105  is modular and removably connected within instrument  100 , thus allowing the easy removal and replacement of subsystem  105 . Accordingly, instrument  100  can be easily repaired and/or reconfigured by simply removing the diagnostic subsystem and replacing it with another. This approach has several advantages. First, it allows a malfunctioning instrument to be easily repaired, even at the end user&#39;s location. This, in turn, minimizes instrument downtime and inconvenience to the user. Second, a modular approach allows the user to easily modify the instrument&#39;s functionality as the user&#39;s needs change. Third, it allows the instrument&#39;s functionality to be modified as new auditory tests are devised, testing protocols are changed and/or improved, etc., thus preventing obsolescence of the instrument and minimizing user costs. 
     As previously noted, instrument  100 , and more specifically diagnostic subsystem  105 , can be configured to perform a wide variety of audiometric tests. In general, diagnostic subsystem  105  can be configured to offer a range(s) of frequencies and/or discrete frequencies, varying intensities and pressures, thus allowing various hearing disorders to be screened and analyzed. Preferably subsystem  105  also includes a 2 cc calibration cavity  417 . As a variety of audiometric tests, and the components needed to perform such tests, are well known by those of skill in the art, a detailed description of each possible configuration of subsystem  105  is not provided herein. Some of the desired testing capabilities of instrument  100  are provided below as a means of illustrating the invention. It will be appreciated, however, that the invention is not limited to these particular tests. Accordingly, some of the auditory tests envisioned by the inventors include: 
     Middle-Ear Testing 
     A variety of middle-ear tests can be performed by instrument  100 , and more particularly diagnostic subsystem  105 , depending upon the desired information, desired instrument cost and complexity, etc. Preferably multiple diagnostic subsystems  105  are used in conjunction with instrument  100  although a single, configurable diagnostic subsystem can also be used, either approach allowing the instrument to be configured to perform simple middle-ear function screening or more thorough middle-ear function diagnostics. 
     In at least one embodiment, diagnostic subsystem  105  is configured to perform tympanometry tests, preferably providing a number of probe tones (e.g., 266 Hz, 678 Hz, 800 Hz and 1000 Hz). Although diagnostic subsystem  105  can be configured to only provide single frequency testing, preferably multiple frequency testing is provided for, thus allowing the middle-ear resonance frequency to be determined. For tymp sweeps, diagnostic subsystem  105  can be configured to allow user defined pressures (e.g., 50 to 400 daPa/sec or higher), AFAP variable pressure speeds, or both. As a result of being able to apply pressure in a controllable fashion, overpressure or underpressure of the middle-ear can be compensated for during testing. 
     In at least one embodiment, diagnostic subsystem  105  is configured to perform acoustic reflex tests and determine acoustic reflex thresholds (both for contralateral stimulation and ipsilateral stimulation). Stimuli frequencies and intensities are preferably user definable, selected from frequencies and intensity ranges allowed by diagnostic subsystem  105 . Preferably diagnostic subsystem  105  is also configured to perform reflex decay measurements. 
     In at least one embodiment, diagnostic subsystem  105  is configured to determine pure tone thresholds via air conduction. For example, subsystem  105  can be configured with a number of frequencies within the desired auditory frequency range and exhibiting the desired dynamic range (e.g., 8 frequencies with a dynamic range of 1-120 dB). 
     In at least one embodiment, diagnostic subsystem  105  is configured to test Eustachian tube functions, preferably allowing the functionality to be tested with either the tympanic membrane intact or perforated. 
     In at least one embodiment, diagnostic subsystem  105  is configured to test acoustic reflex latency and/or perform Gelle&#39;s test. 
     Other Auditory Testing 
     In addition to the tests outlined above, diagnostic subsystem  105  can be configured to perform numerous other auditory tests. For example, in at least one embodiment diagnostic subsystem  105  is configured to measure the acoustic impedance of the outer ear under varying pressure conditions. In at least one other embodiment, diagnostic subsystem  105  is used to perform audiometric emission measurements. In this configuration, probe  117  includes at least one transducer to generate the stimulus signals and at least one transducer to measure the emission signal. In at least one other embodiment, diagnostic subsystem  105  is configured to perform advanced audiometry (i.e., HL or SPL). In at least one other embodiment, diagnostic subsystem  105  is configured to perform ABLB, Stenger and SISI special testing. In at least one other embodiment, diagnostic subsystem  105  is configured to perform high frequency audiometry, preferably up to 16 kHz. 
     User Interface 
     In its simplest configuration, user interface  109  is used to program the desired test parameters into instrument  100 . For example, the various parameters associated with tympanometry and reflex threshold testing can be entered via interface  109 . More specifically, user interface  109  can be used select the function/test to be performed as well as whether the function/test is to be performed manually, automatically, automatically using a preprogrammed test sequence, or using a previously user-entered test profile. Additionally, user interface  109  can be configured to allow setting and or selecting; (i) sensitivity scales (e.g., for tympanometry testing), (ii) tone or frequency, (iii) single versus multiple tones, (iv) tone presentation timing, (v) Eustachian tube testing mode (e.g., perforated vs. non-perforated tympanic membrane), (vi) pressure, etc. 
     In at least one embodiment, user interface  109  is used to set-up the basic operation of instrument  100 . For example, user interface  109  can be used to select the instrument&#39;s operational language, the format for displaying test results (e.g., graphical versus tabular, side by side displays of data, overlaying data, etc.), configuration of user input means  111 , configuration of display means  113 , enable/disable time and/or date stamping of test data, and configuration/control of wireless communication subsystem  121 . 
     In a preferred embodiment of the invention, user interface  109  is used to enter and/or access individual patient data (e.g., patient profile, previous test data, etc.). Preferably interface  109  can also be used to enter and/or access various office management tools such as patient appointment schedules, patient contact information, and/or patient billing information (e.g., payment history). 
     Input means  111  can use any combination of buttons, switches, rotating/scrolling wheels, etc. In at least one embodiment, input means  111  includes a virtual keyboard, preferably an alphanumeric keyboard, graphically displayed on display means  113 . Individual keys of the virtual keyboard are ‘struck’ (i.e., pushed, entered, accessed, etc.) either through the use of a touch sensitive display means or by a combination of key selection buttons (e.g., arrow keys) and an enter button. In at least one other embodiment, input means  111  also includes at least one microphone for use in dictating (e.g., recordable in memory  115 ), preparing voice files for attachment to test data or for communicating with office personnel, etc. 
     In at least one embodiment display means  113  is used to provide the user with various types of information relating to both the configuration and functionality of instrument  100 . For example, display means  113  can be used in conjunction with input means  111  to configure instrument  100  (e.g., selection of interface language), configure wireless communication subsystem  121 , monitor the performance of instrument  100  (e.g., battery charge level), select an auditory test, and select the desired test parameters. In a preferred embodiment, display means  113  is used to communicate test results, either textually or graphically, to the user. In another preferred embodiment, display  113  is used to present the user with patient data (e.g., patient profile, previous test data, etc.) and/or office management information (e.g., appointment schedules, patient and/or supplier contact information, invoice information, etc.). 
     In at least one embodiment, display  113  includes a touch sensitive screen, thus allowing the display to also function as input means  111 . 
     Display means  113  can utilize various screen sizes and resolutions, depending upon power system constraints, expected tests, desired presentation formats, etc. Preferably display means  113  uses organic light emitting diodes (OLED), although other types of technology can be used. For example, display  113  can use liquid crystal display (LCD) technology, light emitting polymers (LEP), electroluminescent (EL) or active matrix electroluminescent (AMEL) technology, organic thin film transistors (organic TFT), amorphous silicon integrated displays (ASID), pliable display technology (PDT) or any other display technology that can provide a suitable resolution in the desired display size. 
     Probes 
     Depending upon the desired configuration, probe  117  can be coupled to instrument either directly or via a probe cable  119 . One benefit of coupling probe  117  directly to instrument  117  is to achieve an extremely compact device. One benefit of coupling probe  117  via cable  119  is to provide the patient with a light-weight probe that does not overly constrict patient movement. 
     Although instrument  100  can use standard probes, in a preferred embodiment probe  117  is an intelligent probe. As used herein, intelligent probe is defined as a probe that includes the ability to communicate probe information to the instrument to which it is attached (e.g., instrument  100 ) in addition to that information commonly communicated via a probe such as stimulus signals and response data. 
     In at least one embodiment, the probe information communicated via the intelligent probe is calibration data. Calibration data can include data about the probe, which is then used by diagnostic subsystem  105  and/or processor  107  to insure proper instrument set-up. Calibration data can also include a date stamp, thus allowing instrument  100  to notify the user when the date stamp indicates that the calibration data is no longer valid. 
     In at least one embodiment, the probe information communicated via the intelligent probe is probe configuration data. Probe configuration data can include information about the capabilities of the probe, thus allowing the diagnostic subsystem to be properly set-up. Preferably diagnostic subsystem set-up is performed automatically upon connecting probe  117  to instrument  100 . Such automatic set-up is sometimes referred to as a plug and play capability. 
     In at least one embodiment, the probe information communicated via the intelligent probe is system operation information. For example, one or more buttons or other types of input means  131  can be included in the body of probe  117 , the buttons allowing test sequences to be initiated and/or stopped without the use of input means  111  on instrument  100 . Preferably buttons  131  on probe  117  duplicate one or more buttons/input means  111  on instrument  100 . In another example of system operation information that can be communicated via the intelligent probe, one or more LEDs or other types of display means  133  can be included in the body of probe  117 . Preferably LEDs/display means  133  provide status information to the user (e.g., test sequence initiating, test sequence complete, etc.). 
     Processor and Memory 
     Processor  107 , in conjunction with memory  115 , provides for instrument  100 &#39;s functionality (e.g., implement tests, analyze test results, manage instrument operation, etc.). As previously noted, instrument  100  can utilize a single processor or multiple processors. For example, diagnostic subsystem  105  can utilize a dedicated processor while a different processor can control the overall operation of the instrument. Accordingly, processor  107  in  FIG. 1  is only intended to represent the processing capabilities of instrument  100 . 
     Memory  115  is preferably used to store information relating to the instrument&#39;s testing capabilities. For example, test sequences and parameters can be stored in memory  115 . These test sequences and parameters can be factory installed and/or user installed and in the case of the latter, are preferably indexable by user, test type and/or patient. Memory  115  can also be used to store test profiles, including probe requirements if probe  117  is an intelligent probe as previously disclosed. 
     In at least one embodiment, memory  115  is used to store test data, preferably including both current test results and previous test results (assuming that the patient has previous test results). Memory  115  can also be used to store standardized test results, thus providing an easy means of gauging a patient&#39;s test results. For example, standardized test results can be based on a segment of the population (e.g., persons within a predefined age group), based on achieving a certain performance level (e.g., superior, average, below average), based on achieving a percentage of what is considered average performance, etc. 
     In at least one embodiment, memory  115  is used to store data and information generally relating to the user&#39;s office, and more specifically relating to the management of the user&#39;s office and professional practice. This data is accessible, and modifiable, through use of input means  111  and displayable through the use of display means  113 . Examples of such data and information are patient profiles, including personal data, medical data, past test results, billing information, etc. Other examples of data and information that can be stored in memory  115  are employee files, appointment records, supply records and payroll records. 
     Short Range Wireless Communication Subsystem 
     Instrument  100  includes a short distance wireless networking subsystem  121  that provides short distance wireless communications between instrument  100  and a correspondingly enabled peripheral electronic device or system (e.g., devices/systems  123 - 125  in  FIG. 1 ). Preferably short distance wireless networking subsystem  121  has a range on the order of 30 feet or less, more preferably on the order of 100 feet or less, still more preferably on the order of 500 feet or less, and yet still more preferably on the order of 1000 feet or less. 
     Short distance wireless networking subsystem  121  includes a transceiver  127  and can utilize any of a variety of networking technologies and protocols, as long as the selected system provides suitable networking capabilities between instrument  100  and the desired device or system (e.g., devices/systems  123 - 125 ). Examples of suitable technologies and standards include Bluetooth and IEEE802.11. As such technologies and standards are well know in the art (see, for example, the specifications found at www.bluetooth.com, www.standards.ieee.org/getieee802/802.11.htm1 and www.grouper.ieee.org/groups/802/11/, all of which are incorporated herein by reference), further description will not be provided herein. Subsystem  121 , which is coupled to an appropriate antenna, controls the communication of data between instrument  100  and the desired device or system. 
     Due to the inclusion of wireless networking subsystem  121 , instrument  100  can communicate with any similarly enabled device. For example, if the user of instrument  100  wants to make a hard copy of some test results, the test results can be sent to a printer (e.g., device  124 ) which is enabled (e.g., using a Bluetooth adaptor). If the user wants to construct on-screen audiograms in real time, and assuming instrument  100  is NOAH compatible as it is in a preferred embodiment, test data can be feed directly to an enabled PC database via wireless networking module  121 . In an alternate example, wireless networking subsystem  121  can be used to communicate data (e.g., patient data, office management data, etc.) between instrument  100  and either an enabled computer (e.g., device  123 ) or an enabled local area network (LAN) (e.g., system  125 ) or another similarly enabled device (e.g., facsimile devices, personal digital assistants, cellular telephones, etc.). In yet another example, assuming that instrument  100  includes a schedule (e.g., appointment schedule, personal schedule, etc.), wireless networking subsystems  121  can be used to send a reminder such as an e-mail, voice message (e.g., using a voice file or a voice synthesis system), or other reminder to an appropriately enabled receiver (e.g., enabled personal digital assistant, enabled cellular phone, etc.). It will be appreciated that the above examples of the possible uses for wireless networking subsystem  121  arc meant to be illustrative only and that the present invention is not limited to these applications. 
     As will be understood by those familiar with the art, the present invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. Accordingly, the disclosures and descriptions herein are intended to be illustrative, but not limiting, of the scope of the invention which is set forth in the following claims.