Abstract:
A sensing and analyzing device for determining when physical limits of a patient have been exceeded by the patient during exercise is provided. The device may comprise a sensing unit, analyzing unit and a warning unit. The sensing unit may be attached to critical locations on a body of the patient. The sensing unit may be operative to sense pressure. The analyzing unit may be attached to a convenient location on the patient&#39;s body. The analyzing unit may be operative to receive pressure data from the sensing unit to determine whether the patient has exceeded the physical limits of the patient. The warning unit may communicate with the analyzing unit and be activated by the analyzing unit when the physical limit of the patient has been exceeded for notifying the patient when the patient&#39;s physical limits have been exceeded.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application claims the benefits of U.S. provisional patent application Ser. No. 60/683,077, filed May 23, 2005, the entire contents of which is expressly incorporated herein by reference. 
     
    
     STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT  
       [0002]     Not Applicable  
       BACKGROUND OF THE INVENTION  
       [0003]     1. Field of the Invention  
         [0004]     The present invention relates to the field of sensing and analyzing devices and more particularly to a novel device which is worn by a patient for dynamic sensing and recording of physiological information while under stress in order to prevent the patient from exceeding predetermined physical limitations.  
         [0005]     2. Description of the Prior Art  
         [0006]     In the past, it has been the conventional practice for persons engaging in recovery physical therapy to exercise by running, walking, or employing other physical procedures in which the person is under stress and may exceed physical limits which will adversely affect recovery and may even cause damage. For example, a person having a leg or arm injury may be advised to perform daily exercise of the limb in order to aid recovery. In following such a procedure, the limb is placed under stress, and the muscles, ligaments and other tissues may not have recovered in sufficiency to permit overload or excessive exercise. Such excessive experience may cause additional stress and may even physically damage the muscles or other body organs which are intended to be conditioned.  
         [0007]     Therefore, a long-standing need has existed to provide a sensing and analyzing apparatus that would sense, analyze and monitor the person&#39;s physical condition while under stress. A warning device is included in the apparatus whereby the person may be notified when the physical limits for his particular condition has been reached or exceeded.  
       SUMMARY OF THE INVENTION  
       [0008]     Accordingly, the above problems and difficulties are avoided by the present invention which employs a sensor and analyzing device which is releasably worn on the limb of the user and that includes a plurality of pressure pad sensors strategically located, such as on the sole of the user&#39;s foot. The plurality of sensors are connected to an analyzer unit by means of a flexible cable wherein the cable may be adjustable in length for comfort and wearability. The analyzer unit includes an adjustable threshold logic circuit for setting limits not to be exceeded by the user during an exercising procedure. A memory network is included for storing information derived during the exercise procedure and a sampler logic circuit which is connected to a clock is coupled between the adjustable threshold logic and the memory network so that periodic information is sampled and placed into the memory network according to a preset timing schedule. Alarm means include visual, audible and vibratory devices coupled to the adjustable threshold logic so that the user may be alerted when exercising limits have been approached or exceeded. Furthermore, an external analyzer remotely located, such as in a physician&#39;s office, may be attached to the memory network via the flex cable for receiving the results of information stored during the full memory network so that periodic information is sampled and placed into the memory network according to a preset timing schedule. Alarm means include visual, audible and vibratory devices coupled to the adjustable threshold logic so that the user may be alerted when exercising limits have been approached or exceeded. Furthermore, an external analyzer remotely located, such as in a physician&#39;s office, may be attached to the memory network via the flex cable for receiving the results of information stored during the full exercise procedure.  
         [0009]     In an aspect of the sensor and analyzing device, a physiological sensing and analyzing device that is strategically located on the body of a patient undergoing physical exercise for alerting the user to cease exercising as his or her physical limit is close or beyond preset limits is provided.  
         [0010]     In another aspect of the physiological sensing and analyzing device, a novel medical device for alerting a patient during an exercise procedure that his physiology is in jeopardy due to his exceeding physical limits as determined by a physician&#39;s standards is provided.  
         [0011]     still another aspect of the physiological sensing and analyzing device, a novel sensing and analyzing medical device adapted to be worn by a person undergoing physical stress which will notify the wearer that further exercise or further intensity of exercise is approaching the limits of stress necessary for recovery is provided.  
         [0012]     In yet another aspect of the physiological sensing and analyzing device, an alarm system on a sensor and analyzing device adapted to be comfortably worn by a patient so that the patient will be notified and alerted by sound, vibrations, or visually, that he is approaching or has exceeded physical limitations is provided. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]     These and other features and advantages of the various embodiments disclosed herein will be better understood with respect to the following description and drawings, in which like numbers refer to like parts throughout, and in which:  
         [0014]      FIG. 1  is a perspective view illustrating the novel sensor and analyzing device in use on a limb of a patient;  
         [0015]      FIG. 2  is an enlarged side elevational view, partly in section, of the sensor and analyzing device shown in  FIG. 1 ;  
         [0016]      FIG. 3  is a bottom view of a patient&#39;s sole illustrating placement of sensors in critical locations;  
         [0017]      FIG. 4  is an enlarged sectional view of a typical sensor as employed in the sensor arrangement shown in  FIG. 3  as taken in the direction of arrows  4 - 4  thereof;  
         [0018]      FIG. 5  is a side elevational view of the analyzer unit shown in  FIG. 1  and illustrating a retaining strap, in sectional view;  
         [0019]      FIG. 6  is a block diagram illustrating the arrangement of circuit and network relationships for the sensor and the analyzer unit; and  
         [0020]      FIG. 7  is an enlarged perspective view illustrating the adjustable connection to lengthen or shorten the flex cable extended between the sensors as shown in  FIG. 3  and the analyzing unit as shown in  FIG. 2 , as well as providing connection for external analyzer equipment. 
     
    
     DESCRIPTION OF PREFERRED EMBODIMENT  
       [0021]     Referring now to  FIG. 1 , the novel sensor and analyzing device is illustrated in the general direction of arrow  10  which includes a case or housing  11  which is carried on a portion of the patient or user&#39;s body, such as the user&#39;s leg. For illustrative purposes, the device  11  is carried adjacent to the user&#39;s lower leg and is held thereon by a strap  12  which temporary secures the case or housing  11  in a suitable position and location. An on/off switch  13  is available for depression by the user in order to control the operation of the device. The device includes an alarm means which, in one form, may take the embodiment of a visual signal, such as energizing of lights, such as light  14 . An elongated flex cable is indicated by numeral  15  which may include a lower portion and an upper portion releasably coupled together by connectors  19 . The flex cable includes a plurality of conductor runs leading from a sensor means, as shown in  FIG. 3 , to a circuit board in the housing  11 .  
         [0022]     Referring now in detail to  FIG. 2 , the housing  11  encloses various components of the unit which includes a nine-volt battery  16 , the switch  13 , and a plurality of LED lights which includes light  14 . In addition to the LED&#39;s in the alarm means, an audible alarm  17  is included as well as a buzzer  18  which provides a vibratory signal. The buzzer resides adjacent the user&#39;s body so that the vibrating signal will alert the user in the same manner that the lights  14  and/or the audible signal  17  does.  
         [0023]     It can also be seen in  FIG. 2  that the elongated flex cable  15  is attached to the connectors of a circuit board within the unit or housing  11  and that the flex cable terminates in a sensing means at its opposite distal end. The sensing means includes short lengths of flex cable, such as indicated by numerals  20 ,  21 , and  22  which terminate in sensing pads  23 ,  24 , and  25 . The elongated flex cable  15  may be provided with connectors along its length so as to permit length adjustment of the flex cable in order to accommodate the placement of the housing  11  in a critical location on the user&#39;s body. Connector points  26  and  27  may be placed at suitable locations along the length of the elongated flex cable  15  to permit shortening or lengthening of the cable, as well as being useful in connecting with external or remote devices. Also these connections or points may take the form of those disclosed in the U.S. Pat. No. 6,739,878. Sensitivity adjustments means, such as indicated by numeral  30 , are provided.  
         [0024]     Referring now in detail to  FIG. 3 , it can be seen that the sensing means is carried on the distal end of cable  15  and is represented by the numeral  31 . As illustrated, it can be seen that the pressure pads  23 ,  24  and  25  are placed at strategic or critical locations on the bottom or sole of the user&#39;s foot. For example, sensor pad  23  is placed on the heel of the user&#39;s foot, while pads  24  and  25  are placed immediately behind the toes of the foot.  
         [0025]     Referring now in detail to  FIG. 4 , an enlargement is shown of pressure pad  23  which is illustrated in broken lines in a depressed condition when the weight of the user is applied to the sensor. The pressure is transferred through the cladding of the cable segment  20  to change the resistance in a conductor  32  which is then introduced to the analyzing portion of the system. Similar resistance changes or modifications are created by the depression of pads  24  and  25  which are combined in the analyzing portion of the system.  
         [0026]     In  FIG. 5 , it can be seen that the buzzer  18  is exposed on the back of the housing  11  so as to touch the skin of the user. Thereby, any vibration of the buzzer will notify the user that threshold levels of exercise are being exceeded or approached. Also, a cushion pad  33  is placed on the backside of housing  11  so as to provide comfort when the housing is worn on the limb or other portion of the user&#39;s body.  
         [0027]     Referring now in detail to  FIG. 6 , it can be seen that the change of resistance signals from the sensors  23 - 25  inclusive are introduced to an adjustable threshold logic network  34  which are then transferred to a memory chip  35  for storage and comparison with previously stored statistical data. The transfer is through a clock  36  and a sampler logic network  37  so that introduction of the signals is made in a timed sequence. A power source  16  is represented by the battery. For remote review of the statistical material stored on the memory chip  35 , an external analyzer  38  is used. The external analyzer may be detachably connected to the system using the connectors  26  and  27  and such a connection  19  is further illustrated in  FIG. 7 .  
         [0028]     In  FIG. 7 , the remote device, such as the analyzer  38 , may be detachably connected by means of a flexible cable  40  having prongs  41  and  42  which are inserted into the connector receptacles  26  and  27  respectively.  
         [0029]     In view of the foregoing, it is to be noted that the flex interconnection allows for easy replacement and also that the control pads allow expansion for load-bearing sensitivity. The flex cable has an adjustment connector and that each sensor can be positioned to match the size of the user&#39;s foot.  
         [0030]     The device may be placed on a patient having a foot, leg, knee, and/or hip injury, for example, or on a limb requiring corrective surgery. The device may be strapped in. a critical location so as to sound or alarm when the patient has exceeded a doctor prescribed shift in weight and/or angle of stance. The use of pressure sensitive pads whose resistance or voltage output changes depending upon the amount of pressure placed on the sensor area is incorporated into the instrumentation. After defining the electrical outputs of a desired sensor material, as relating to the calculated weight span of a normal human being, an electrical circuit allowing for variable sensor positioning is employed where the electric outputs can be continuously monitored by computer logic circuits.  
         [0031]     The circuitry allows for an adjustable threshold to be set and may be determined by a physician, the setting of which, when reached, activates an alarm, such as a vibrating unit like a buzzer, placed against the skin of the user or may employ a visual LED light and/or a siren alarm. The electronics operate on a standard replaceable 9-volt DC battery  16 .  
         [0032]     The electronics are inclusive of an electronic clock set by the physician to activate a “sampler” circuit, where the sensor information is automatically sampled remotely at the physician&#39;s remote computer. The sampling is programmed in time and stored in a memory chip so that when the patient returns to the doctor&#39;s office, the doctor can download the sample data and review the same for diagnosis purposes. The electronic sampler can further be programmed using specially developed software to identify special instructions from/to the physician, such as temperature, pressure, etc. Additional proven ceramic sensors can be added to the same insole and positioned to take an ultrasonic view of the stressed area when the sample is taken as defined by the physician and stored in the memory, and again, download and the picture printed for later review by the physician.  
         [0033]     The electronic package unit  11  has been designed so as to be small in size and to fit the patient&#39;s extremity or limb or other body portion and uses soft adjustment bands to retain the device in position. The interconnect or flex cable has an “adjustable length feature” making use of pressure point contact or flexible cable connectors, as disclosed in U.S. Pat. No. 6,739,878. The electronic sensor data is communicated from the variable location of the sensors on the bottom of the limb up to the conductors of a flat, flexible polyimide insulated cable to a connector-less pressure point set of connections entering the bottom of the computer logic board in the housing  11 . As can be seen, the computer logic board may be reused while the sensor flexible cable circuit is easily detached from the connector-less interconnect and readily replaced.  
         [0034]     The sensors and flat flexible conductor may be mounted in a more rigid limb conforming support, such as an insole which conforms to the patient&#39;s foot and/or can be mounted in a cast as determined by the physician.  
         [0035]     The product incorporating the present invention has many areas of application but most urgent applications involve foot surgery and recovery therefrom.  
         [0036]     The above description is given by way of example, and not limitation. Given the above disclosure, one skilled in the art could devise variations that are within the scope and spirit of the invention disclosed herein. Further, the various features of the embodiments disclosed herein can be used alone, or in varying combinations with each other and are not intended to be limited to the specific combination described herein. Thus, the scope of the claims is not to be limited by the illustrated embodiments.