Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
     Not Applicable 
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not Applicable 
     REFERENCE TO A MICROFICHE APPENDIX 
     Not Applicable 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention pertains generally to neurological diagnostic techniques, and more particularly to an apparatus for performing self-diagnostic measurements of nerve sensory latency such as may be exhibited as a result of carpal tunnel syndrome. 
     2. Description of the Background Art 
     Median nerve compression in the wrist, also called “carpal tunnel syndrome” is becoming an increasingly common disorder that causes pain and suffering, as well as a substantial economic impact. Carpal tunnel syndrome has various causes and predispositions which include genetic, toxic, metabolic and traumatic factors. The leading causes of the disorder stem from cumulative trauma or repetitive motion mechanisms. Primarily, the causative factors are related to the nature of the work performed and the ergonomic environment of the workplace. 
     Carpal tunnel syndrome has become an agonizing disorder for many sufferers while a far larger segment of the population experiences various levels of discomfort and disability. Concomitant economic costs exist which are more easily quantified as costs for medical treatment, disability payments, insurance premiums, along with the economic impact of decreased worker and industrial productivity. 
     The current medical industry consensus is that measuring the time required for a sensory nerve action to cross the wrist after the occurrence of a depolarizing incident is the most definitive test available for nerve compression. Since nerve conduction is bi-directional, the stimulus can be applied to a finger and recorded from the nerve above the wrist, or the converse, wherein each method is valid and should provide equivalent results. Measurements on conduction times in healthy individuals which are not experiencing compression of the carpal nerves provide a narrow range of conduction times which are reproducible over extended time periods. A nerve under compression responds with a lower conduction velocity, and thereby a longer conduction period, or latency, between the stimulus and the response. Ranges of normal latency values have become well known with a number of comprehensive case studies to be found in the literature. 
     Diagnostic testing is currently being performed by professionals, such as neurologists and physiatrists in medical offices, clinics, or in neurophysiology laboratories. Various laboratory and clinical equipment is currently available to allow a medical practitioner to assess patient nerve conduction, however, the expense of purchasing and using these devices has limited their use. The equipment typically being employed by the medical community provides a suite of testing functions and includes a waveform display in addition to a digital readout. A percentage of insurance plans, including Medicare®, require the submission of a waveform graph in order for the test costs to be reimbursed. Presently the fee for performing this test (approximately five hundred dollars per examination) puts the technique out of the range of economic feasibility for many applications. 
     Due to the cost and limited accessibility of the equipment and practitioners, only a small minority of patients receive the definitive testing, and often by the time the testing is performed, the severity of the nerve compression already warrants surgery. The screening of a larger segment of the population to monitor ongoing sensory nerve conduction of those performing vigorous or repetitive motion activities would be a welcome and valued asset within industry, government, and in the field of ergonomics which endeavors to assess and remediate this major debilitating disorder. 
     Carpal tunnel syndrome may be caused by a number of factors, of which “occupational neuropathy” is but one of at least twenty five identified causes as described in Baker&#39;s Textbook of Clinical Neurology. Other common causes include pregnancy, diabetes, congestive heart failure, arthritis and familial heredity. The screening efforts for carpal tunnel syndrome by professionals and their agents or technicians, has focused on larger organizations with known or suspected risk factors. A large percentage of workers, therefore, are unserved by these screening methods, such as those laboring in small businesses, trades or crafts, services and farms, along with many self-employed workers. 
     Therefore, a need exists for an inexpensive, easy to operate instrument which provides self-diagnostic screening of nerve latency such as median nerve latency which is exhibited as a result of carpal tunnel syndrome. The present invention satisfies those needs as well as others, and overcomes the deficiencies of previous approaches. 
     BRIEF SUMMARY OF THE INVENTION 
     The present invention provides an apparatus for self-diagnosis of nerve sensory latency that is suitable for providing self-diagnostic evaluation of carpal tunnel syndrome. The apparatus provides a series of stimulus pulses at a first electrode while the nerve responses to those stimulus pulses are monitored at a location farther along the nerve path. The apparatus calculates the latency, or delay, from each stimulus to each response, and provides a readout of the latency period. The controls and readout of the apparatus make it ideal for self-diagnostic evaluation of carpal tunnel syndrome as well as other conditions wherein a nerve sensory latency is exhibited. 
     Once the apparatus is activated, the user is free to position the stimulator probe with their free hand, as they are not required to interact with the apparatus to initiate each stimulus pulse. By way of example, the unit may be connected with a stimulus probe positioned just above the wrist and a recording electrode located on a finger. Unless nerve compression is occurring, the delay between stimulus and response along the nerve should typically be less than three milliseconds. Mechanical pressure on the nerve increases conduction time, and this increase, which is referred to as “prolongation”, is proportional to the applied pressure. The apparatus of the present invention provides a portable unit configured to allow for self-diagnostic evaluation. The exemplified unit is designed for wide deployment as it can be manufactured from low cost circuitry. By increasing availability and lowering cost; it is anticipated that periodic evaluation will be made feasible so that early detection and treatment can be provided, perhaps without surgery. 
     An object of the invention is to provide an apparatus for performing self-diagnostic analysis of sensory nerve latency, such as that exhibited as a result of carpal tunnel syndrome. 
     Another object of the invention is to provide accurate measurement of prolongation. 
     Another object of the invention is to provide an easy to use and low cost portable carpal tunnel diagnostic apparatus. 
     Another object of the invention is to provide a carpal tunnel diagnostic apparatus having low power consumption and the ability to operate from a single battery. 
     Another object of the invention is to provide a carpal tunnel diagnostic apparatus having an output display that provides unambiguous nerve propagation readings. 
     Further objects and advantages of the invention will be brought out in the following portions of the specification, wherein the detailed description is for the purpose of fully disclosing preferred embodiments of the invention without placing limitations thereon. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The invention will be more fully understood by reference to the following drawings which are for illustrative purposes only: 
     FIG. 1 is a perspective view of a self-diagnostic nerve sensory latency evaluation apparatus according to the present invention shown held in the hand of the user and connected for evaluating median nerve sensory latency. 
     FIG. 2 is a perspective view of a self-diagnostic nerve latency evaluation apparatus according to the present invention shown held in the hand of the user and connected for evaluating ulnar nerve sensory latency. 
     FIG. 3 is a block diagram of the self-diagnostic nerve latency evaluation apparatus according to the present invention. 
     FIG. 4 is a schematic of the display, driver circuits, and latency measurement circuitry according to an aspect of the present invention. 
     FIG. 5 is a schematic of the power supply circuit according to an aspect of the present invention. 
     FIG. 6 is a schematic of the stimulus circuit according to an aspect of the present invention. 
     FIG. 7 is a schematic of the response sensing circuit according to an aspect of the present invention. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring more specifically to the drawings, for illustrative purposes the present invention is embodied in the apparatus generally shown in FIG.  1  through FIG.  7 . It will be appreciated that the apparatus may vary as to configuration and as to details of the parts, and that the method may vary as to the specific steps and sequence, without departing from the basic concepts as disclosed herein. 
     Referring first to FIG. 1, a self-diagnostic nerve sensory latency apparatus  10  according to the present invention is shown connected to a user for measuring carpal tunnel prolongation. The apparatus  10  is shown with a base unit  12  connected to the hand  14  of a user performing a self-examination. The apparatus is preferably held in the hand  14  of the user to provide beneficial grounding (a neutral), for improved measurement accuracy. The hand  14  (shown in phantom along with intended apparatus positioning) of the user is shown with wrist  16  along with thumb  18   a  and fingers  18   b  through  18   e . A stimulator probe  20 , having electrodes  22   a ,  22   b , is connected to the base unit  12  by a wiring harness  24 . The stimulator electrodes  22   a ,  22   b  are shown positioned in topical proximity with the median nerve on the underside of the wrist (on the middle of the palm side of the wrist). The negative electrode (cathode)  22   a  is shown oriented toward the hand, while the positive electrode (anode)  22   b  is shown oriented toward the forearm. A recording electrode  26  is shown connected on the user&#39;s index finger by a pair of rings  28   a ,  28   b , and is also shown connected to the base unit  12  by a wiring harness  30 . 
     The base unit  12  includes a display  34  upon which the latency readings are registered, a power-on switch  36 , and a stimulator amplitude control  38 . A snap connection  40  is shown on one end of the unit for the attachment of an optional retention strap or the like which provides improved retention and conduction with the hand of the user. The retention strap for this embodiment (not shown) is preferably configured with a snap proximal to one end for attachment to snap connection  40 , and a strip of hook-and-loop fastener, such as Velcro®, to mate with the corresponding hook-and-loop fastener section  42  on the top of base unit  12 . Preferably the strap would contain conductive material to further enhance grounding and the user would simply pull the strap around the back of their hand and over onto the hook-and-loop fastener to secure the unit to their hand. It will be appreciated that the added securement provided by the strap can be implemented using a variety of straps or clips configured with any of numerous fastening mechanisms. The connection to the strap may also be utilized should an application arise in which the apparatus can not be hand-held, such as in the case of a post-surgically bandaged hand, wherein the strap may be held to the hand or a longer grounding strap employed to electrically connect the case of the apparatus to the hand of the patient. 
     It will be appreciated that the apparatus housing may be configured in various shapes to enhance placement within the hand of the user. For example, the apparatus can be constructed of plastic in a variety of smooth cornered shapes wherein the exterior conductivity is achieved by applying metal powder coating, or a similar conductive material, to the exterior of the housing so that advantageous grounding for the apparatus within the hand of the user is provided. 
     In use, the apparatus is first placed in the hand of the user with the optional strap being fastened if added security is desired. The recording electrode  26  is then attached proximal to a position along a nerve pathway for which the nerve response is to be measured. In the illustrated embodiment, electrode rings  28   a ,  28   b , (positive and negative, respectively) are shown annularly disposed on the index finger  18   b  of the user. The recording electrode rings may be placed on the index finger, or the middle finger, with the cathode (−) at the base, and the anode (+) approximately an inch toward the tip of the finger. It is beneficial to enhance the electrical contact of the stimulator probe  20  and the recording electrodes  26  with the skin surface. Enhanced conductivity may be accomplished by lightly coating the rings and probes with a conductive paste or gel. Commercial conductive gels are available and numerous simple household items may alternatively be used, such as toothpaste. 
     Once base unit  12  is activated by switch  36 , electrical stimulus pulses travel from base unit  12  through wiring harness  24  to the stimulator probe  20 . The stimulator probe  20  is placed proximal to the opposing end of the nerve segment of interest, in this case the median nerve, such that the stimulus pulses are now being transmitted along the median nerve to the recording electrode  26 . The amplitude of the stimulus pulses is set by means of amplitude control  38  which is initially adjusted to a low amplitude, or a known amplitude as set from a prior use. 
     A brief twitch of the muscles at the base of the thumb will occur as the motor nerves are activated. The motor nerve twitching indicates that a proper contact path along the nerve has been established and that the stimulus voltage is sufficiently high, since the threshold for activation of the sensory branch (being evaluated) is lower than the threshold for motor nerves. Users quickly adapt to the unusual sensation of the very brief shock pulses and the associated muscle twitch. 
     A series of latency measurements are then registered on the display  34  providing the user with diagnostic information about the sensory delay along the particular nerve being evaluated, which in this case is the median nerve. High latency periods exceeding approximately three-milliseconds for the median nerve often are attributable to the compression of the median nerve by the carpal tunnel which is the condition commonly referred to as carpal tunnel syndrome. A reading below three milliseconds covers at least 95% of normal, asymptomatic subjects. The higher reading is even more meaningful if the subject has been experiencing numbness or tingling in the hand or fingers. In view of the simple self-diagnostic procedure and the low cost for the apparatus itself, periodic diagnostic evaluations can be warranted for individuals at-risk of repetitive motion activities or for checking the positive effects of ergonomic interventions designed to mitigate repetitive motion effects. Response to simple treatments such as wrist splinting or bracing may also be evaluated. The latency time recorded by the diagnostic evaluation may vary by a few tenths of a millisecond if the fingers or hand are cool or cold. In such instances the hand may be warmed in water prior to evaluation so that a nominal exterior body temperature is achieved. 
     Referring now to FIG. 2, the user with similar ease may self-diagnose sensory latency of the ulnar nerve along the nerve pathway from above the wrist to the little finger. Here, electrode rings  28   a ,  28   b  are placed on the fifth (small or pinky) finger  18   e  and the stimulator probe  20  is moved proximal to the ulnar nerve on the underside of the wrist. The user may be required to reposition the stimulus probe on the wrist until stable readings are provided on the display  34 , so as to properly locate the ulnar nerve pathway. An accompanying muscle twitch is expected to occur in the small muscle bulge (hypothenar), between the fifth finger and the wrist, which is a further indicator of proper stimulus contact with the ulnar nerve. The sensory latency interval along the ulnar nerve is typically less than that for the median nerve due to the shorter anatomical length along the segment of ulnar nerve. The ulnar nerve is not carried through the carpal tunnel of the wrist, and as a result prolongation is not exhibited by the ulnar nerve in response to carpal tunnel syndrome. Therefore, if the median nerve sensory latency of the user exceeds the ulnar latency by more than approximately one millisecond, then this provides definitive evidence that the median nerve of the patient is being compressed and that the user has carpal tunnel syndrome. 
     FIG. 3 is a representative block diagram  50  for the electronic circuitry for the embodied self-diagnostic nerve sensory latency evaluation apparatus. The output  52  of the apparatus comprises a pair of electrode outputs  54   a ,  54   b  from the stimulator circuit  56  to which wiring harness  24  (and electrodes  22   a ,  22   b ) is connected. The pulse voltage generated between the positive and negative electrodes stimulate the nerves in the nearby nerve pathway such that the nerve response travels along the pathway and is sensed by the recording electrode. To assure sufficient voltage for the stimulus, a charging circuit  58  boosts the source voltage used within the apparatus, as supplied by a single battery, to a sufficient voltage level to provide an adequate electrical stimulus. Battery voltage is preferably boosted by means of a charge pumping arrangement within the charging circuit  58 . The timer  60  provides numerous functions at the core of the embodied apparatus circuitry. For example, timer  60  generates timing signals for the charging circuit and measures the time that elapses between each generated stimulus pulse and each attendant response which is detected. The charging circuit  58  provides a signal to the timer  60  when the charging output has reached a sufficient voltage level. The timer  60  subsequently triggers the stimulus pulse from the stimulator  56 . Upon triggering the stimulus pulse the timer is reset to a known state (preferably zero) and begins counting upward. The response is monitored along the nerve pathway by electrode input connection  62  comprising a positive electrode input  64   a , a neutral input  64   b , and a negative electrode input  64   c . Positive  64   a  and negative  64   c  inputs are connected to wiring harness  30  (and recording electrode rings  28   a ,  28   b ). The neutral for the recording electrode is in electrical contact with the exterior of the apparatus case, or a portion thereof, to provide a neutral reference (a ground) on the hand of the patient so as to improve the signal to noise ratio for the diagnostic testing. The signal received between the positive and negative electrode inputs  64   a ,  64   c , are amplified by pre-amp  66  to generate a signal which is then filtered by filter  68 . A peak detector  70  receives the filtered signal and generates an output to timer  60  when the peak of the response to the stimulus pulse arrives. The peak response of the incoming signal provides a repeatable position within the response from which to measure the response timing. Using a peak detector provides additional noise immunity in relation to using a fixed threshold as the characteristic of the incoming signal determines the detection and is less prone to false triggering by noise within the signal. The response signal from the peak detector  70  is received within the timer as a load signal wherein the count value is loaded to a display driver  72  and visually indicated on display  74 . The timer then continues counting such that at a predetermined count a subsequent stimulus pulse is generated, whereas timing of a subsequent interval commences. 
     Referring to FIG. 4, an embodiment of circuitry  90  implementing the timer and display elements previously described is shown as a simplified schematic of integrated circuits and signal routing. An oscillator  92  provides a signal at a predetermined frequency as the clock to a counter  94 , herein exemplified as a dual binary-coded-decimal (BCD) counter having a first decade whose output cascades to a second decade counter. The output from the second decade counter within counter  94  is received by a counter  96 , exemplified as another dual binary-coded-decimal (BCD) counter. In combination, the counters provide four decimal decades, although it will be appreciated that a variety of counter depths can be accordingly supported. The BCD outputs of three of the counter stages are received by display driver circuits  98 ,  100 ,  102 , which are exemplified as three BCD to seven-segment liquid crystal display (LCD) driver chips. The drivers in turn provide the segment drives for a three-digit LCD display  104 . The counters  94 ,  96 , in addition to providing for the measurement of the nerve sensory latency periods, provide outputs used for timing of the LCD backplane signal, signals used for driving the charge pump, and a signal for triggering the pulse from the stimulator circuit. The backplane of the LCD is driven by a clock derived from an intermediate counter output which is also received as a phase signal for the drivers so that the segments may be driven in opposite phase of the backplane. In addition, a fixed decimal point within the LCD is shown being driven by a transistor inverter  106  coupled to the backplane signal. As the stimulator pulse is generated, the counters  94 ,  96  are reset to zero and then begin counting up from zero. During this time, the display drivers  98 ,  100 ,  102 , contain a latched BCD value from a previously recorded measurement which is displayed on the LCD  104 . A LOAD signal is generated upon arrival of the peak response of the stimulator pulse at the recording electrode. The LOAD signal is received by the drivers whereupon the current BCD count of the counters is loaded into the drivers  98 ,  100 ,  102 , which updates the display  104 . After receipt of the LOAD signal, the counters continue to count up until a high-order bit of the counter goes active to trigger a subsequent stimulus pulse and reset the counters for timing another nerve latency interval. 
     FIG. 5 shows an embodiment of the power source  110  for the apparatus. Power from a battery  112  is controlled by switch  114  to provide power  116  to the regulator circuitry for the apparatus. A set of voltage regulators are also shown which provide the separate isolated voltages necessary within the circuit. Regulator  118  provides voltage VD 3  of approximately three-volts, while regulator  120  provides V 3  of approximately three-volts with which the three-volt output of regulator  122  is summed to provide V 6  a six-volt output. Regulators  120  and  122  thereby provide a split supply for the op-amps with a positive and negative three volts in reference to the center voltage V 3 . 
     FIG. 6 shows an embodiment of the stimulator and charge-pump circuitry  130  according to the invention. The charge pump boosts the achievable output voltage by stepping up the battery voltage by a process of adding amounts of charge during successive time intervals to thereby “pump up” the voltage on a capacitor. This charge-pump circuit  132  receives two oscillator signals OSC and OSC 2  to drive the pumping phases wherein voltages are essentially “stacked” onto output capacitor  134  in which the stimulus charge is built-up. When the output capacitor reaches a sufficiently high charge level, a sense circuit  136  generates a READY signal. The timer triggers the stimulus pulse by a signal OSC 1  to a switching device  138  which discharges the voltage on capacitor  134  as a current pulse through transformer L 1 . The voltage from capacitor  134  is thereby stepped-up to further increase the output voltage. Preferably, the output voltage of the stimulator can be set to a sufficiently high voltage to allow for proper conduction under the given conditions. Within the exemplified embodiment, transformer L 1  has a turns ratio of 1:10 which provides for a maximum stimulus output voltage around 200 VDC in the illustrated circuit. The width of the stimulus pulse delivered through the transformer is preferably about 0.5 milliseconds. The output of transformer L 1  is clamped by protection diode D 1  and is output on the electrodes of the stimulus probe attached to connector  140  to induce a current across the electrodes. The switching device  138  is herein exemplified as a high-voltage protected MOS FET transistor. The amplitude of the stimulus pulse is regulated by a variable resistor  142  which provides the optional pulse amplitude control  38  as shown in FIG.  1  and FIG.  2 . 
     FIG. 7 shows an embodiment of response detection circuitry  150  for detecting the electrical response which has traversed along a nerve pathway as a result of the stimulus signal from the stimulator. A gain stage  152  contains a connector  154  for connecting with the recording electrode, the signal from which is amplified by op-amp  156 . A second stage  158  primarily provides filtering of unwanted noise components from the signal and comprises two op-amps  160  and  162 . A third stage  164  provides a signal peak-detector for the circuit comprising an op-amp  166  and a capacitive storage element containing C 8  and C 9  within the feedback loop for storing a charge voltage to which the signal is compared. Upon peak detection, the op-amp  166  generates a LOAD signal which is used for loading the BCD count value from the counters into the display drivers while it additionally resets the charge element within the feedback loop in preparation for the next stimulus/response cycle. 
     It will be appreciated that the above description is for the circuitry of a single embodiment for the self-diagnostic analysis apparatus of the present invention and that numerous variations may be derived by one of ordinary skill in the art without departing from the inventive teachings. 
     Accordingly, it will be seen that this invention provides an apparatus for self-diagnostic evaluation of nerve sensory latency such as that which is characteristic of carpal tunnel syndrome. The apparatus has been developed to allow the user to conduct the measurements on themselves with a single free hand. Furthermore, the apparatus has been designed with a single-battery power source to minimize size weight and cost, and the circuitry within the apparatus developed for simplicity and low power consumption so that the units may be mass-produced for wide distribution. It will be appreciated that the illustrated schematics were provided by way of example and that the numerous variations will be obvious to one skilled in the art without departing from the inventive teachings. 
     Although the description above contains many specificities, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of this invention. Thus the scope of this invention should be determined by the appended claims and their legal equivalents. Therefore, it will be appreciated that the scope of the present invention fully encompasses other embodiments which may become obvious to those skilled in the art, and that the scope of the present invention is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.” All structural, chemical, and functional equivalents to the elements of the above-described preferred embodiment that are known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the present claims. Moreover, it is not necessary for a device or method to address each and every problem sought to be solved by the present invention, for it to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element herein is to be construed under the provisions of 35 U.S.C. 112, sixth paragraph, unless the element is expressly recited using the phrase “means for.”

Technology Category: 1