Abstract:
A system for creating an eye-movement record that is useful for diagnosing balance disorders of a patient includes a head-mounted unit having an indicator which generates head position signals. Also included is a computer/controller for progressing the patient through a sequence of predetermined head orientations. An imaging unit in the head-mounted unit is used to create an eye-movement record for each head orientation, and the records are then archived in a recorder. With instructions from the patient, a de-identified eye-movement record can be sent to selected regional specialists for further evaluation and possible treatment.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention pertains generally to systems and methods for diagnosing balance disorders. More particularly, the present invention pertains to head-mounted diagnostic units that can be individually used for generating eye-movement records in an outpatient environment. The present invention is particularly, but not exclusively, useful as a system and method for creating confidential eye-movement records that are maintained and controlled by the person creating the record. 
       BACKGROUND OF THE INVENTION 
       [0002]    Vertigo (i.e. dizziness) is a symptom of a balance disorder that can result for any of various reasons. Anatomically, vertigo results when crystals in the inner ear of an individual are erratically misaligned. In some instances, vertigo may be only temporary, such as when the pilot of an aircraft becomes spatially disoriented while flying on instruments. Vertigo, however, can also be pathological. In any event, it is known that a patient will experience erratic eye-movements during vertigo. For diagnostic purposes, it is known that properly stimulated eye movements can be evaluated to determine whether pathological conditions exist. More specifically, it is well known that a properly trained specialist (physician) can evaluate the results of a Dix-Hallpike Maneuver, or a recognized equivalent of this maneuver, and thereby diagnose the nature and extent of a balance disorder. 
         [0003]    Heretofore, some degree of supervision has been required for the conduct of a Dix-Hallpike Maneuver. Always, it has been, and still is, necessary for a trained specialist to make a proper diagnosis. Nevertheless, the conduct of a Dix-Hallpike Maneuver requires no medical intervention, and it can be accomplished merely by prompting the patient through a sequence of predetermined head orientations. Images of eye movements taken in the different head orientations can then be evaluated and used to diagnose any balance disorder. 
         [0004]    As noted above, vertigo may result for many various reasons. And, for many different reasons, a patient may want to maintain confidentiality for his/her condition (balance disorder). Accordingly, it is desirable there be a system that is available for use by a patient, either alone or with proper supervision, to obtain a reliable diagnosis from a trained specialist under confidential circumstances in an outpatient status. 
         [0005]    With the above in mind, it is an object of the present invention to provide a system for collecting eye-movement data to create an eye-movement record that can be used as a diagnostic of balance disorders, wherein the eye-movements are responsive to a sequence of changes in head orientation, and wherein a required sequence of head orientations are prompted by computer control. Another object of the present invention is to provide a system for creating eye-movement records wherein the required sequence of head orientations can be performed individually without assistant supervision. Still another object of the present invention is to provide a system for creating confidential eye-movement records that can be archived and controlled by the patient for subsequent evaluation and possible treatment. Yet another object of the present invention is to provide a system for creating eye-movement records that is simple to use, is easy to assemble, and is comparatively cost effective. 
       SUMMARY OF THE INVENTION 
       [0006]    In accordance with the present invention, a system and method are provided for collecting eye-movement data that can be used to create a plurality of eye-movement records. Collectively, the plurality of eye-movement records is then used as a diagnostic for evaluating balance disorders. For this purpose, a patient&#39;s eye-movements are responsive to the sequence of changes in head orientation prescribed for a Dix-Hallpike Maneuver. Importantly, as envisioned for the present invention, the eye-movement data can be generated individually by the patient, without assistant supervision, while in an outpatient status. Also, the resultant eye-movement records can be maintained and confidentially controlled by the patient. 
         [0007]    Structurally, the system of the present invention includes goggles that can be positioned and worn on the head of the patient. An indicator is mounted on the goggles and is to be moved with the head of the patient. In particular, the indicator is incorporated to generate position signals that are respectively indicative of each predetermined head orientation required by the Dix-Hallpike Maneuver. Specifically, the Dix-Hallpike Maneuver consists of head movements through a sequence of seven separate head orientations. 
         [0008]    In order, these orientations are: 
         [0009]    1. patient sits with head centered; 
         [0010]    2. patient sits with head 45 degrees to the right; 
         [0011]    3. patient lays back with head 45 degrees to the right and held in approximately 20 degrees of extension; 
         [0012]    4. patient sits back up with head centered; 
         [0013]    5. patient sits with head 45 degrees to the left; 
         [0014]    6. patient lays back with head 45 degrees to the left and held in approximately 20 degrees of extension; and 
         [0015]    7. patient sits back up with head centered. 
         [0016]    Along with the indicator, an imaging unit with a camera is also mounted on the goggles. Like the indicator, the imaging unit is intended to move with the head of the patient to create eye-movement records. Further, the system includes a recorder that is connected to the imaging unit to archive the eye-movement records as they are created by the imaging unit. 
         [0017]    A computer/controller for operating the system is connected to the indicator, to the imaging unit, and to the recorder. Also, the computer/controller is externally connected with a regional data base that contains respectively pertinent information on a plurality of specialists. In this combination, a central server is incorporated with the recorder (i.e. the computer/controller) for forwarding confidential eye-movement records to the data base for subsequent use by at least one selected specialist in response to instructions from the patient. 
         [0018]    In an operation of the system of the present invention, the patient positions the goggles on his/her head. The computer/controller then notifies the patient that an operation of the system will begin when his/her head is moved into the starting orientation required by the Dix-Hallpike Maneuver. In response to a notification from the computer/controller that the head of the patient is being properly held in the predetermined orientation, the patient presses on a “go” button. This activates the imaging unit. Specifically, the camera of the imaging unit then creates an eye-movement record while the head of the patient is held substantially stationary in the particular orientation for a preselected time interval (e.g. less than about ten seconds). Once an eye-movement record has been created at one predetermined orientation, the computer/controller then notifies the patient to move his/her head to the next sequentially predetermined orientation of the patient. All of this is done in accordance with a computer program. In this next orientation, another eye-movement record is created. Thus, an eye-movement record is created with collected eye-movement image data at each head orientation. After completion of the Dix-Hallpike Maneuver, the plurality of eye-movement records are collated and archived at the recorder. As indicated above, the recorder can be connected to an external data base which contains pertinent information on a plurality of specialists. Thereafter, in response to instructions from the patient, these eye-movement records are available for evaluation and use by selected specialists. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0019]    The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which: 
           [0020]      FIG. 1  is a schematic diagram of a system for creating eye-movement records in accordance with the present invention; 
           [0021]      FIG. 2  is a schematic of an environment for operation of the system of the present invention; and 
           [0022]      FIG. 3  is an operational flow chart for the creation of eye-movement records in accordance with the present invention. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0023]    Referring initially to  FIG. 1  a system for collecting eye-movement data, and for creating eye-movement records with the collected data, is shown and is generally designated  10 . As shown, the system  10  includes goggles  12  that can be placed on the head of a patient  14 . The import here is that the goggles  12  are to be held stationary on the head of the patient  14 , for movement with the head of the patient  14 . It is also shown in  FIG. 1  that the goggles  12  include an indicator  16 , and that they are connected with an imaging unit  18 . For the present invention, the indicator  16  can be any type of inertial orienting device that is known in the pertinent art, and that is capable of identifying a spatial, three dimensional orientation for the head of patient  14 . Also, it is to be appreciated that the imaging unit  18  includes a camera (not shown) for generating images of eye movements. For the system  10 , the camera is mounted on the goggles  12 . 
         [0024]    Still referring to  FIG. 1 , it is shown that the system includes a computer/controller  20  that is mounted on the goggles  12  to essentially control the operation of system  10 . This control is accomplished in accordance with a computer program  22 . Further,  FIG. 1  shows that a recorder  24  is electronically connected between the imaging unit  18  and an archive  26 . Preferably, the recorder  24  is also mounted on the goggles  12 . With this connection, the images of eye-movements (i.e. data) that are generated by the imaging unit  18 , can be passed from the recorder  24  to the archive  26  where they will be collected, collated and stored for future use, as desired by the patient  14 . It is also seen in  FIG. 1  that an audio capability  28  is provided within the system  10  so that the computer/controller  20  can effectively give instructions to the patient  14 . In response to these instructions, the patient  14  has the control of a “go” button  30  that is connected directly to the computer/controller  20 . Use of the “go” button  30  is disclosed below, in detail, in conjunction with an operation of the system  10 . 
         [0025]    As envisioned for the present invention, the system  10  can be used in a clinical environment, in a physician&#39;s office, individually by the patient  14  at a remote site, or in any other appropriate outpatient location. Regardless where the system  10  is used,  FIG. 2  indicates that the system  10  will normally be connected directly to a data base  32 . The different systems  10   a ,  10   b  and  10   c  shown in  FIG. 2  are only exemplary of such connections.  FIG. 2  also shows that the data base  32  is accessible by a plurality of specialists  34 , individually or collectively. 
         [0026]      FIG. 3  presents a flow chart  36  for an operation of the system  10 . In detail, after the computer/controller  20  has been programmed and turned “on”, block  38  indicates that the system  10  is to be checked. This involves ensuring that the goggles  12  are properly placed on the head of the patient  14 , and that the system  10  is otherwise prepared for its operation. In this instance, block  40  requires the number of sequential eye-image iterations to be accomplished during an operation of the system  10  (i.e. n) be initially set with n=1. Block  42  of the flow chart  36  then requires the total number of iterations to be accomplished be set to the number m. For the present invention, m is the number of different head orientations x that are to be established in accordance with the Dix-Hallpike Maneuver. In this case, the Dix-Hallpike Maneuver requires head movements through a sequence of seven separate head orientations. Thus, m=7. In order, these orientations are: 
         [0027]    1. patient sits with head centered; 
         [0028]    2. patient sits with head 45 degrees to the right; 
         [0029]    3. patient lays back with head 45 degrees to the right and held in approximately 20 degrees of extension; 
         [0030]    4. patient sits back up with head centered; 
         [0031]    5. patient sits with head 45 degrees to the left; 
         [0032]    6. patient lays back with head 45 degrees to the left and held in approximately 20 degrees of extension; and 
         [0033]    7. patient sits back up with head centered. 
         [0034]    As indicated by block  44  of the operational flow chart  36 , there is an operational cycle for each of the n different head orientations in the Dix-Hallpike Maneuver. In this context, the computer/controller  20  uses the audio  28  to tell the patient  14  what he/she is to do for each head orientation. For example, the initial operational cycle (x 1 ) requires the patient  14  move to a sitting position with his/her head centered. Block  44  specifies this action, and the patient  14  then complies with a prompt from the audio  28  and moves his/her head to the orientation prescribed for the operational cycle (i.e. x 1 ). Additionally, the computer program  22  requires confirmation that the patient&#39;s head is still, and is in the proper orientation in the video screen of the imaging unit  18  for proper video acquisition. At this point, the indicator  16  on goggles  12  will electronically inform the computer/controller  20  that this has been successfully accomplished (see inquiry block  46 ). Next, the computer/controller  20  informs the patient  14  that his/her head is properly oriented for x 1 . When so informed, the patient  14  then presses on the “go” button  30  and the imaging unit  18  records eye-movement data (see action block  48 ) for a predetermined interval of time (e.g. ten seconds). After the time interval has expired (see inquiry block  50 ) the eye-movement data that is taken for x 1  is used to create an eye-movement record. Action block  52  then indicates this eye-movement data is processed by the recorder  24  and sent to the archive  26  for storage. 
         [0035]    Action block  54  indicates that after an eye-movement record has been created for x 1 , n is incremented to 2 (i.e. the system  10  will now function with x 2 ). Since m is 7 and n is 2, inquiry block  56  returns operation to action block  44  and the patient  14  will again be instructed by audio  28 . This time, however, the patient  14  will be instructed to remain sitting and move his/her head 45° to the right. Thus, another operational cycle is initiated (i.e. x 2 ) and an eye-movement record will be created for x 2 . According to the flow chart  36 , these cycles of operation continue until x 7  has been accomplished and the Dix-Hallpike Maneuver has thereby been completed. At that time, action block  58  indicates that a complete set of eye-movement records are collated and passed to the archive  26 . In addition to a video archive of eye-movement records, a dynamically positioned head movement data set is generated. This data set is collected and stored in each recording for subsequent evaluation and verification that the patient&#39;s head was still during the actual recording session. 
         [0036]    Returning to  FIG. 1 , it will again be appreciated that the eye-movement records (i.e. x 1  through x 7 ) of many different patients  14  can be assembled at the centralized data base  32 . Typically, however, these records will be de-identified before they are transferred to the data base  32 . Thus, the confidentiality and use of the various eye-movement records are strictly maintained by the individual patient  14 . Furthermore, once they are at the data base  32  the eye-movement records can be identified with a particular patient  14 , only by instructions from the patient  14 . Also, only with instructions from the patient  14  can eye-movement records be released from the data base  32  for use and evaluation by specialists  34 . 
         [0037]    In a preferred embodiment of the present invention, the indicator  16 , the imaging unit  18  with its camera, the computer/controller  20  and the recorder  24  are integrated into a cohesive assembly. This assembly is then mounted (i.e. clipped) onto the goggles  12  and is used as a self-contained unit. 
         [0038]    While the particular System and Method for Collecting Eye-Movement Data as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that it is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended to the details of construction or design herein shown other than as described in the appended claims.