Patent Abstract:
A wrist watch system is provided. The wrist watch system includes at least one sensor configured to detect biometric data of a user; and a watch communicatively coupled to the at least one sensor and configured to removably couple to a wrist of the user. The watch includes an output device configured to display data from the at least one sensor and a communication device configured to transmit, to an external source, data received from the at least one sensor.

Full Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a continuation application of U.S. patent application Ser. No. 11/625,879 filed on Jan. 23, 2007, which is a continuation of U.S. patent application Ser. No. 10/421,965, now issued as U.S. Pat. No. 7,182,738. The contents of each of the above-identified applications are herein incorporated by reference in their entirety. 
     
    
     BACKGROUND 
       [0002]    1. Field 
         [0003]    The present disclosure relates to a patient monitoring system and method that can be used, for example, with an orthosis for physical therapy. 
         [0004]    2. Description of Related Art 
         [0005]    In the field of medicine, rehabilitation after surgery or other major medical procedures has been an important issue for researchers. As shown in U.S. Pat. Nos. 5,395,303; 5,285,773; 5,213,094; 5,167,612; 6,502,577; 6,113,562 and 5,848,979, continuous passive motion has been used to treat conditions such as the glenohumeral joint adhesive capsulitis. These patents teach using stretching principles in order to treat one of the major problems patients are referred to physical therapists for: lack of a full range of motion in their joints. The orthosis devices of these patents simulate manual therapy techniques used in clinical settings, combining the principles of stress relaxation and progressive stretch to achieve permanent elongation of soft tissue. 
         [0006]    Once a patient has been prescribed treatment with one of the rehabilitation orthosis devices, a major concern is patient education and compliance. To maximize improvement in range of motion the patient must comply with the prescribed protocol and the patient improvement must be tracked. The exercise protocol for these orthosis devices is well established, and should be followed closely to ensure the best treatment possible. First, the patient fits the orthosis as specified by the device specific instructions. Then the patient rotates the knob of the orthosis device until a slight stretch is felt. This stretch should not be painful. Now the patient holds this position for a predetermined time period (e.g., five minutes), and then this procedure is repeated for a predetermined number of stretches (e.g., 6 stretches). During the first week of the patient&#39;s treatment, typically one session a day is performed. During the second week, typically two sessions per day are performed. During the third and following weeks, typically three sessions per day are performed. 
         [0007]    The above described orthosis devices allow the patient to do these sessions outside of the confines of the doctor&#39;s or physical therapist&#39;s office. Due to the fact that there are no medically trained personnel to oversee this treatment the opportunity to stray from the protocol is introduced. In addition, the patient is responsible for the tracking of his or her own progress until reporting back to the physical therapist or doctor. Both of these conditions have the possibility of introducing a high margin of error. Most recently, physicians have expressed an interest in keeping better records of an individual patient&#39;s progress during the rehabilitation process. Unfortunately, in many cases, since the rehabilitation process occurs mostly within the confines of the patient&#39;s home, it is difficult for a physician to keep an accurate record of the patient&#39;s progress. 
         [0008]    There are other areas in which patient education and compliance outside the immediate supervision of a health care professional remain problematic. For example, electrical stimulation of bone growth for treatment of fractures requires a regime of therapy that demands patient adherence in order to optimize the stimulatory effects. 
         [0009]    Thus, there exists a need for an improved patient monitoring system and method. 
       SUMMARY 
       [0010]    In one embodiment of the disclosure, a wrist watch system is provided. The wrist watch system includes at least one sensor configured to detect biometric data of a user; and a watch communicatively coupled to the at least one sensor and configured to removably couple to a wrist of the user. The watch includes an output device configured to display data from the at least one sensor and a communication device configured to transmit, to an external source, data received from the at least one sensor. 
         [0011]    In another embodiment of the disclosure, a wrist watch system is provided. The wrist watch system includes A wrist watch system includes at least one sensor configured to determine biometric data of a user and a watch communicatively coupled to the at least one sensor and configured to removably couple to a wrist of the user. The watch is configured to receive a user data protocol, prompt the user to perform a first task related to the received protocol, record biometric data relating to a first user task from the at least one sensor, transmit the recorded biometric data, and display the recorded biometric data. 
         [0012]    In another embodiment of the disclosure, one or more non-transitory computer-readable storage media having computer-executable instructions embodied thereon is provided. When executed by a processor, the computer-executable instructions cause the processor to record, by a wrist watch, biometric data of a user from at least one sensor communicatively coupled to the wrist watch, display, by the wrist watch, the recorded biometric data, and transmit the recorded biometric data to an external source. 
         [0013]    In another embodiment, the monitoring system notifies the patient that the time period for holding a stretch has terminated in accordance with a stretching protocol. 
         [0014]    Consistent with the title of this section, the above summary is not intended to be an exhaustive discussion of all the features or embodiments of the present disclosure. A more complete, although not necessarily exhaustive, description of the features and embodiments of the disclosure are found in the section entitled “Detailed Description”. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]    A more complete appreciation of the present disclosure and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein: 
           [0016]      FIG. 1  is a view of an illustrative orthosis device used with the monitor in accordance with the present disclosure. 
           [0017]      FIG. 2  is an enlarged sectional view of tower of  FIG. 1  including the drive mechanism. 
           [0018]      FIG. 3  is a block diagram of the monitoring system in accordance with the present disclosure. 
           [0019]      FIG. 4  is a block diagram of the hardware used in the monitor of the present disclosure when in the treatment mode of operation. 
           [0020]      FIG. 5  is a block diagram of the hardware used in the monitor of the present disclosure when in the data transfer mode of operation. 
           [0021]      FIG. 6  is a schematic diagram of the position sensor used in the present disclosure. 
           [0022]      FIG. 7  is a flow chart of the firmware embedded in the monitor of the present disclosure. 
           [0023]      FIG. 8  is a detailed schematic of the hardware used in the monitor of the present disclosure. 
           [0024]      FIG. 9  is a schematic of the circuitry for the sensors used in the monitor of the present disclosure. 
           [0025]      FIG. 10  shows circuit diagram of an alternative embodiment of the monitor which includes a device type sensor in accordance with another aspect of the present disclosure. 
       
    
    
     DETAILED DESCRIPTION 
       [0026]    Referring to  FIGS. 1 and 2 , there is illustrated one of many possible prior art orthosis devices, generally indicated by the reference number  10 , which may be used with the patient monitor of the present disclosure. More specifically, this particular illustrative orthosis device  10  is described in U.S. Pat. Nos. 5,395,303; 5,285,303; 5,285,773; 5,213,094; and 5,167,612 to Bonutti, et al., which are incorporated herein. 
         [0027]    In  FIG. 1  the orthosis device  10  is illustrated as attached to a human arm, for moving the elbow joint which is between the upper arm and the forearm. The orthosis  10  includes a first cuff  12  for attachment to a first body portion  14  such as the forearm, and a second cuff  16  for attachment to a second body portion  18  such as the upper arm. The term “cuff” as used herein means any suitable structure for transmitting the force of the orthosis to the limb portion it engages. The first body portion  14  is joined to the second body portion  18  at the elbow joint designated A. Each of the first and second cuffs  12  and  16  includes a plurality of loop connectors  20  for receiving straps extending around the body portions  14  and  18  to clamp the cuffs  12  and  16  to the body portions  14  and  18 . The first cuff  12  is mounted for sliding movement on a first cuff arm  22 . The term “cuff arm” as used herein means any suitable structure for transmitting the force of the orthosis to the cuff and thence to the limb portion. The first cuff arm  22  is pivotally mounted by a pin  24  to a tower  26 . The first cuff arm  22  includes a support  28 . A first lever arm  30  extends from the tower  26  and is pivotally connected to the support  28  by a pin  32 . The first lever arm  30  is pivotally connected to a cuff actuator block  34 . The cuff actuator block  34  is fixed to the first cuff  12  and is slidable along the first cuff arm  22  in a manner as described below. The second cuff  16  is mounted for sliding movement on a second cuff arm  40 . The second cuff arm  40  is pivotally mounted by a pin  42  to the tower  26 . The second cuff arm  40  includes a support  44 . A second lever arm  46  extends from the tower  26  and is pivotally connected to the support  44  by a pin  48 . The second lever arm  46  is pivotally connected to a cuff actuator block  50 . The cuff actuator block  50  is fixed to the second cuff  16  and is slidable along the second cuff arm  40  in a manner as described below. 
         [0028]    As shown in  FIGS. 1 and 2 , the tower  26  is a box-like structure including a lower housing  66  and an upper housing  70  joined by a front plate (removed) and a back plate  53 . A drive mechanism for the orthosis device  10  is disposed substantially within the tower  26 . The drive mechanism includes a manually actuatable knob  52  ( FIG. 1 ) which is fixed to a shaft  54 . The shaft  54  extends into the tower  26  and a gear  56  ( FIG. 2 ) is fixed to the shaft. The gear  56  engages external gear teeth  58  on a gear  60 . Rotation of the gear  56  about its axis causes rotation of the gear  60  about its axis. The gear  60  is fixed to an externally threaded lead screw  62 . One end of the lead screw  62  is journalled for rotation in a bushing  64  mounted in a lower housing  66  of the tower  26 . The opposite end of the lead screw  62  is journalled for rotation in a bushing  68  mounted in an upper housing  70  of the tower  26 . An arm actuator block or base link  72  has an internally threaded opening  74  though which the lead screw  62  extends in threaded engagement. As the lead screw  62  rotates, the actuator block  72  moves axially along the lead screw  62  within the tower  26 . This mechanism provides the “rotating means” for rotating the first cuff arm  22  relative to the second cuff arm  40  and thereby expanding or reducing the angular relationship there between. 
         [0029]    In operation, the orthosis device  10  of the prior art may provide for distraction of the joint through an entire range of motion. Movement of the cuff arms to extend the joint results in distractive forces being applied to the joint. These distractive forces are limited and controlled by having the cuffs  12  and  16  slidable on the cuff arms  22  and  40 , respectively. The cuffs  12  and  16  are selectively moved along the cuff arms  22  and  40 , during relative movement of the cuff arms  22  and  40 , to provide the proper amount of distractive forces to the joint and to limit compressive forces on the joint. Thus, the orthosis device  10  illustrates one of many orthosis devices that are well suited for stretching therapy. 
         [0030]    It should be understood that the orthosis device  10  can be used to extend or flex other joints in the body, such as a knee joint or a wrist joint or ankle joint, with the construction of the orthosis  10  in such case being varied to fit the particular application. A few more illustrative examples are shown in U.S. Pat. No. 6,502,577 for finger joints orthosis, U.S. Pat. No. 6,113,562 for a shoulder orthosis, and U.S. Pat. No. 5,848,979 for a hand orthosis. Moreover, it is contemplated that the monitoring unit of the present disclosure may also be used for other types of devices, including, but not limited to, rehabilitative devices implementing isometric exercises and those in the continuous passive motion (CPM) area. 
         [0031]    To generalize the description of the one class of orthosis devices that may be used with the present disclosure, such as orthosis devices including (but are not limited to) the stretching orthosis device  10  of  FIGS. 1 and 2 , isometric orthosis devices, and CPM orthosis devices, the following generic terminology is used in the appended claims. The orthosis devices used with the monitoring system in accordance with the present disclosure generally are for moving a first portion and a second body portion of a patient connected by a joint. These orthosis devices typically include a first carriage member for receiving the first body portion and a second carriage member for receiving the second body portion. Each carriage member has proximal and distal ends. The second carriage member and the second carriage member are movably connected about their proximal ends so that the first carriage member pivots relative to the second carriage member about an axis intermediate to the first and second carriage members. Hence, the carriage members may move from a first position to a second position and in so doing change the angle defined by the two carriage members. 
         [0032]    In the illustrative embodiment of the stretching orthosis shown in  FIGS. 1 and 2 , the first and second carriage members each include the cuff arm  22  or  40  and a cuff  12  or  16  for connecting cuff arm  22  or  40  to one of said body portions  14 , with the cuff  12  or  16  slidably mounted on the cuff arm  22  or  40 . In other orthosis devices not directed toward stretching exercises, such those directed toward isometric exercises, the first carriage member and the second carriage member are merely pivotally connected at their proximal ends (frequently adjustably locked in fixed relationship). An example of a simplified orthosis device is shown in U.S. Pat. No. 5,116,296 to Watkins et al. and is incorporated herein by reference thereto. Another example is described in U.S. Pat. No. 5,052,375 to Stark et al. (also incorporated herein by reference thereto), wherein the two carriage members are interconnected by an adjustable hinge and the angle between the respective distal end sections can be adjusted relative to one another. The angular position between the first carriage member and the second carriage member is one of the parameters that is measured by the monitoring system in accordance to be present disclosure, but as will be discussed hereinafter, the monitoring system includes other sensors for measuring other parameters, such the identification of the orthosis device to eliminate the need for external unit configuration and temperature as an indication the orthosis device is actually being used. 
         [0033]    In the case of using the temperature and device identification sensors, the monitoring system of the present disclosure may be used with any number of different types of orthosis devices. More specifically, any orthosis device needing assurances that the user is actually wearing the orthosis device during his/her exercise period using the orthosis, and not falsifying usage, may make use of the monitoring system of the present disclosure for temperature measurements which provides evidence that the orthosis is being properly used. Likewise, with monitors using different parameters or firmware for different orthosis devices, the family of orthosis devices may make use of the device type identification sensor, which will allow the monitor to access the connect parameters and/or firmware appropriate for a particular orthosis device without the need for parameters and/or firmware to be downloaded to the monitor. 
         [0034]    Referring to the block diagram of  FIG. 3 , a patient monitoring system  100  for use with a device such as a physical therapy orthosis, like the orthosis device of  FIGS. 1 and 2 , is shown. The patient monitoring system  100  includes a standalone monitor  102  which can be incorporated into the orthosis device of  FIGS. 1 and 2 . More specifically, the monitor  102  has a data acquisition unit  104  mounted on the outside of the tower  26  (shown by a dashed line), such tower  26  being described with respect to  FIGS. 1 and 2 . Additionally, the monitor  102  includes a plurality of sensors  105 , three of which are shown in  FIG. 3  as a position sensor  106 , a temperature sensor  108 , and an optional device type sensor  110 . As shown by the dashed line, the temperature sensor  102  and the device sensor are mounted on one of the cuff arms  22  and/or  40  shown in  FIGS. 1 and 2 . 
         [0035]    As an overview of the monitoring system  100  when applied to a stretching orthosis such as that shown in  FIGS. 1 and 2 , a patient is prescribed treatment by a physician or physical therapist, with the prescribed treatment using a given orthosis device having a monitor  102 . In a first mode of operation (data transfer or administrative mode), the appropriate orthosis device is modified to fit a patient&#39;s specific requirements by the physician or physical therapist down loading the required parameters to the monitor  102 . This data transfer mode of operation is used only by the physical therapist or doctor. 
         [0036]    In a second mode of operation (treatment mode), the user connects the sensors  105  to the data acquisition unit  104 . The monitor  102  controls each exercise session with the patient by stepping the patient through his or her treatment following the previously described stretching protocol. During the critical sections of this treatment in a first mode of operation, the monitor  102  monitors the operation by taking measurements from the sensors  105  and storing them in memory. These retrieval and storage operations are accomplished via a micro-controller and an EEPROM, which will be described in detail hereinafter. Preferably, the unit  104  is able to store approximately two months worth of sessions. Alternatively, the data can be transmitted to another data storage unit. This transmission can occur instantaneously or at set intervals. 
         [0037]    At the time of the follow-up appointment with a physician or physical therapist, the user disconnects the unit  104  from the orthosis device and disconnects the sensors  105 . Then the user brings the unit  104  to the physician or physical therapist. At this point, the unit  104  again uses the data transfer mode of operation. The information is transferred from the unit  104  to a computer  112  at the office of physician or physical therapist. The memory containing such data in the unit  104  is then erased. This computer  112  uses data analysis software to further manipulate the data and present it for display by the computer  112 . 
         [0038]    Overviews of the hardware of the data acquisition unit  104 , as configured in the above-described modes of operation, are provided in  FIGS. 4 and 5 . The data acquisition unit  104  includes a microprocessor  120  (PIC16F877) and an external memory  122 . In both  FIGS. 4 and 5 , the microprocessor  120  (PIC16F877) uses the external memory  122  and is electrically coupled to a display device  124 , in the form of a parallel LCD.  FIG. 4  shows the hardware configured for the treatment mode, wherein the microcontroller  120  is electrically coupled to the sensors  105  via buses  126  and  128 .  FIG. 5  shows the hardware configured in the data transfer mode to be in communication with the computer  112  via a cable  130  coupled to an RS-232 port  132  on the microprocessor  120 . The MAX  233 , shown by reference numeral  133 , is a Maxim MAX233a device which is used to convert the serial communication voltages used on the microprocessor  120  to the RS-232 levels required by the computer  112 . 
         [0039]    With reference to  FIGS. 3 ,  4  and  5 , the two modes of operation of the monitor  102  will be described in detail, with the mode of operation being set by the computer  112  via the cable  114 . The data transfer mode is entered when the monitor  102  is turned on with the monitor-to-PC cable  114  being inserted into the data acquisition unit interface provided by the port  116  of the monitor  102 . As described above, this mode is used for the configuration of the monitor  112  as well as the retrieval of the acquired data after the monitor is returned by the patient. Through device configuration by the computer  112  various options may be set allowing the monitor  102  not only to be used with the illustrative orthosis device of  FIGS. 1 and 2 , but also to be used with the entire family of rehabilitation devices without modifying the hardware or firmware of the data acquisition unit  104 . The device configuration options are stored on various orthosis devices in the memory  122 . The communications protocol for configuring the monitor  102  is provided below in TABLE I: 
         [0000]    
       
         
               
               
               
               
             
           
               
                 TABLE I 
               
               
                   
               
               
                   
                   
                 Expected 
                   
               
               
                 Command 
                 Name 
                 Arguments 
                 Description 
               
               
                   
               
             
             
               
                 0x00 
                 Send data 
                 none 
                 Sends the patient data to the 
               
               
                   
                   
                   
                 PC via the RS-232 port. 
               
               
                 0x11 
                 Set reps 
                 number of reps 
                 Set the number of stretches 
               
               
                   
                   
                 (ASCII) 
                 the patient performs per 
               
               
                   
                   
                   
                 session. 
               
               
                 0x22 
                 Set mins 
                 number of 
                 Set the number of minutes 
               
               
                   
                   
                 minutes (ASCII) 
                 the patient will hold each 
               
               
                   
                   
                   
                 stretch. 
               
               
                 0x33 
                 Set secs 
                 number of 
                 Set the 10&#39;s position of the 
               
               
                   
                   
                 seconds (ASCII) 
                 number of seconds to hold 
               
               
                   
                   
                   
                 each stretch. 
               
               
                 0x44 
                 Set ID 
                 device id 
                 Sets the device ID. The first 
               
               
                   
                   
                   
                 time monitor is restarted &amp; 
               
               
                   
                   
                   
                 connected to orthosis device 
               
               
                   
                   
                   
                 after setting the device ID, 
               
               
                   
                   
                   
                 the user will be prompted 
               
               
                   
                   
                   
                 to configure the device. 
               
               
                 0x55 
                 Set clock 
                 minutes (BCD) 
                 Sets and configures the 
               
               
                   
                   
                 hours (BCD) 
                 real time clock with the given 
               
               
                   
                   
                 date (BCD) 
                 arguments. 
               
               
                   
                   
                 month (BCD) 
               
               
                 0x66 
                 Set mask 
                 comparison mask 
                 Sets the mask used to 
               
               
                   
                   
                   
                 compare measurements for 
               
               
                   
                   
                   
                 position sensor. This is used 
               
               
                   
                   
                   
                 to compensate for noisy 
               
               
                   
                   
                   
                 sensors. 
               
               
                 0xFF 
                 Delete 
                 none 
                 Marks all data as deleted 
               
               
                   
                   
                   
                 from the EEPROM storage. 
               
               
                   
               
             
          
         
       
     
         [0040]    It should be noted, that with the above protocol, the device id (identification) is set by the computer  112 . In this embodiment, the device type sensor  110  shown in  FIG. 3  is not used. Optionally, the device type sensor  110  may be used, in which case the “id” command is not needed. The alternative embodiment using the device type sensor  110  is described hereinafter. 
         [0041]    The treatment mode is used when connected to the sensor  105  through the data acquisition unit interface  132 . The sensor hardware unit contains all the necessary circuitry for the operation of the current sensors  105  as well as power and ground for the expansion ports. Referring back to  FIGS. 1 ,  2  and  3 , the temperature sensor  108  is embedded into one of the cutis  22  or  40  of the orthosis device  10 . The temperature sensor  108  is not necessarily intended for an accurate measurement of the patient&#39;s body temperature while using the orthosis device  10 , but is a way to ensure that the patient is actually wearing the orthosis device  10  during the treatment session. 
         [0042]    Modifications to the tower  26  shown in  FIG. 2  to include the position sensor  106  of  FIG. 3  are shown in the schematic diagram of  FIG. 6 . Referencing to  FIG. 6 , the overall structure remains the same as shown by the lead screw  62 , lower housing  66 , actuator block  74 , and upper housing  70 . What is added is a spring  130  which extends from the lower housing  66  to the upper housing  70  and is disposed in parallel relationship with the lead screw  62 . The spring  130  passes through an aperture  132  in the actuator block  74 . An electrical contact  134  is embedded in the upper housing  70  and is in electrical contact with an upper end of the spring  130 . A second electrical contact  136  is embedded in the actuator block  74  and is in electrical engagement with the spring as it slidingly passes through the aperture  132  when the actuator block  74  is moved along the lead screw  62 , such movement being caused by the rotation of the lead screw, as discussed with respect to  FIGS. 1 and 2 . More specifically, referring back to  FIGS. 1 and 2 , in addition to  FIG. 6 , the rotation of the lead screw  62  is used to drive the device cuffs  22  and  40 . As the knob  52  on the exterior of the tower  26  is turned, the actuator driver  72  moves up and down accordingly, thus moving the cuffs  22  and  40 . By placing the contact  136  on the actuator driver  72  and one at the top of the spring, a variable resistor is created. This variable resistor is then used in a voltage divider circuit (shown hereinafter) to create a center-tapped potentiometer to monitor the angle formed by the arms  22  and  40  during the treatment. 
         [0043]    Referring to  FIGS. 3-5 , the first time that the hardware sensors  105  are attached after the device identification number has been set during the above described data transfer mode, the user will be prompted to extend the orthosis device  10  to the maximum and then the minimum position to calibrate the device  10 . These measurements are then stored in the memory  122  for use during the remainder of the treatment sessions to calculate the angle between the arms of the device  10 . 
         [0044]    Referring to  FIG. 7 , both the treatment mode of operation and the data transfer mode of operation for the monitor  102  are described in a flow chart of a firmware program  140 , which is embedded in the data acquisition unit  104 . At step  142 , the firmware program  140  waits until a button is pushed by the physician or physical therapist specifying the selected mode of operation. At step  142 , the mode is checked, and if the user selected the treatment mode, the program  140  branches to the “Treatment” branch. If the user selects the data transfer mode of operation, then the program  140  branches to the “Data Transfer” branch. 
         [0045]    After the patient/user begins his or her treatment session, the monitor  102  has already been set for the treatment mode of operation. First, a splash screen is displayed with the name and version of the firmware included in the data acquisition unit  104 . The session runs according to the following flow chart shown in  FIG. 7 , as shown on the left side. At step  146 , the user is prompted to tum the knob  52  (see  FIG. 1 ) until a gentle stretch is felt. At step  146 , the program checks to see if there is power on the sensor bus. If yes, the program goes to step  150  and if no, the program branches to step  152 . The micro-controller  120  at step  150  begins taking measurements of the position sensor  106  in the tower  26  (see  FIG. 3 ) to see if the patient has stopped stretching. The micro-controller  120  (see  FIG. 3 ) continues in a loop  154  until the current position measurement of the position sensor  106  matches the last one, which indicates that the patient has stopped stretching. More specifically, the user definable mask, set via the RS-232 port in data transfer mode, is used to compensate for noisy sensors  106 , and the natural variation in analog to digital conversion. When the two position measurements of the position sensor  106  match, it is assumed that the user of the orthosis device  10  has stopped turning the knob  52  and is ready to hold the stretch. The position sensor  106  of  FIG. 6 , in combination with execution of this firmware routine, provides the “position sensor means” for detecting when there is a stop in movement of the first arm cuff  22  relative to the second arm cuff  40  when a patient starts to hold a stretch. 
         [0046]    Upon the program determining that the patient has started to hold a stretch, the program proceeds to step  156 , where the power is turned off on the sensor bus and the program waits a preset amount of time, e.g., 5 minutes. As specified in the previously described stretching protocol, the user is to hold the stretch for 5 minutes and the time is displayed on the LCD  124  (see  FIG. 3 ). As shown in Table I above, the time to hold a stretch is also configured in the data transfer mode, which allows for easy modifications of this protocol if needed. This firmware routine provides “timing means” for generating a patient detectable signal aster the expiration of the predetermined time period, with in this illustrative example, is 5 minutes. 
         [0047]    Upon completion of the hold for the stretch, the program  140  proceeds to step  158 , where power is turned on to the sensor bus, all measurements of the sensors are recorded and a sound buzzer is triggered to indicate the end of the period for holding the stretch. More specifically, all of the analog conversions of the sensor  106  are repeated and stored into the memory  122 . When all the measurements are saved, a 16 bit address pointer for the memory  122  is updated in the micro-controller. If the user interrupts a stretch before it is completed, then that session will automatically be overwritten by the next session without the need for more complicated error checking. At step  152 , if the number of stretches is less then the amount defined by the treatment protocol, the stretch loop is repeated via loop  160 . If the number of stretches completed is equal to the amount defined by the treatment protocol at step  152 , then a session complete prompt is displayed on the LCD  124  and the program  140  proceeds to step  162 , where the power is turned off and then the program goes to sleep at step  164 . 
         [0048]    Referring to the right side of the flow chart in  FIG. 7 , the data transfer mode of operation is shown. As previously described with respect to  FIG. 5 , the data acquisition unit  104  is in communications with the computer  112 . First, the physician or physical therapist would have selected this mode of operation and the program would recognizes the same at step  144  and taken the “Data transfer” branch to step  170 . If there is a timeout, the program  140  proceeds to a sleep state at step  172 . If there is no timeout, then the program proceeds to step  174 , where the micro-controller of  120  ( FIG. 5 ) fetches an instruction from the computer  112 . The instructions from the computer  112  include, but are not limited to, the commands listed in TABLE I above. The micro-controller  120  interprets the instruction at step  176 . Depending upon the instruction, the program takes the “transfer” branch or the “delete” branch. 
         [0049]    When the program  140  takes the “transfer” branch, at step  178 , the program sends the product ID to the computer  112 . Then at step  180 , all the sensor data is transferred from the memory  122  to the computer  112 . When the program  140  takes the “delete branch”, at step  182 , the program  140  obtains from the computer  122  the product ID (see TABLE I above), then sets the product ID at step  184  and erases the existing sensor data by setting all sensor data to 0xFF (see TABLE I above). Then the program  140  proceeds to its sleep state at step  188 . With this embodiment, it should be clear that the device sensor  110  is not included, because the computer  112  sets the device ID. 
         [0050]    In  FIG. 8  a detailed schematic  190  of the hardware for the data acquisition unit  104  of  FIG. 3  is shown, with such hardware having been generally described on a higher level in  FIGS. 4 and 5 . Referring to  FIG. 8 , the micro-controller  120  preferably comprises a Microchip PIC16F877 micro-controller. This PIC16F877 micro-controller is a 40 pin, 8 bit CMOS Flash microcontroller configured using the following pin assignments in TABLE II below: 
         [0000]    
       
         
               
               
               
               
             
               
               
               
               
             
           
               
                   
                 TABLE II 
               
               
                   
                   
               
               
                   
                   
                 Direction/ 
                   
               
               
                   
                 Name 
                 Mode 
                 Port 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                 1 
                 Temp 
                 Analog 
                 RA0 
               
               
                 2 
                 Position 
                 Analog 
                 RA1 
               
               
                 3 
                 Expand 1 
                 Analog 
                 RA2 
               
               
                 4 
                 Expand 2 
                 Analog 
                 RA3 
               
               
                 5 
                 Expand 3 
                 Analog 
                 RA4 
               
               
                 6 
                 LCD RS 
                 Out 
                 RB0 
               
               
                 7 
                 LCD R/W 
                 Out 
                 RB1 
               
               
                 8 
                 LCD E 
                 Out 
                 RB2 
               
               
                 10 
                 Mode 1 
                 In 
                 RB4 
               
               
                 11 
                 Mode 2 
                 In 
                 RB5 
               
               
                 14 
                 Buzzer 
                 Out 
                 RC0 
               
               
                 16 
                 SCL 
                 I2C 
                 RC3 
               
               
                 17 
                 SDA 
                 I2C 
                 RC4 
               
               
                 18 
                 Serial Tx 
                 USART 
                 RC6 
               
               
                 19 
                 Serial Rx 
                 USART 
                 RC7 
               
               
                 20 
                 LCD DB0 
                 Out 
                 RD0 
               
               
                 21 
                 LCD DB1 
                 Out 
                 RD1 
               
               
                 22 
                 LCD DB2 
                 Out 
                 RD2 
               
               
                 23 
                 LCD DB3 
                 Out 
                 RD3 
               
               
                 24 
                 LCD DB4 
                 Out 
                 RD4 
               
               
                 25 
                 LCD DB5 
                 Out 
                 RD5 
               
               
                 26 
                 LCD DB6 
                 Out 
                 RD6 
               
               
                 27 
                 LCD DB7 
                 Out 
                 RD7 
               
               
                   
               
             
          
         
       
     
         [0051]    The external memory  122  is a Microchip 24AA64 12C EEPROM. The memory  122  is connected to the controller  120  via the I2C serial communications bus  192 . The memory  122  has 64K bits of EEPROM and is used for the storage of the patient data. The operation of this device is limited to the low speed bus operation due to the use of a 4 MHz crystal. The LED  124  is a Hitachi 44780 compatible LCD operating in 8 bit parallel mode. The Hitachi LCD is an industry standard, and was chosen because any 14×2 LCD could then easily be substituted. A Dallas Semiconductor DS 1307 I2C real time clock  194  is provided, which is connected to the I2C bus  192  along with the EEPROM memory  122 . This clock  194  is used to record, to the nearest hour, when the actual stretch sessions were performed. This allows the PC software for the computer  112  (see  FIG. 3 ) to group the stretches into sessions. 
         [0052]    This micro-controller  120  has an onboard poll capable of 8-channel analog to digital conversion at 10-bit resolution making it a powerful tool in data acquisition. The controller  120  also supports both SCI and I2C serial communication. The SCI module of the controller  120  is used to communicate with the computer  112  through standard RS-232 port of a RS-232 communications interface  196 . This communications, for example, allows for further analysis of the data by the physical therapist or doctor. The I2C protocol will used to interface with the memory  122  and the real time clock  194 . The use of external memory  122  will be needed as the 128 bytes of EEPROM storage for the internal memory of the controller  120  is insufficient to store the data acquired from the sensors. The controller  120  is electrically coupled to a Piezo buzzer (not shown) via the pin RCO being connected to the terminal  199 . 
         [0053]    In  FIG. 8 , there is also shown the header  198  (including insulated terminals or leads) for connecting the LCD  124  of  FIGS. 4 and 5 . Also, there is shown a header  200  for connecting with the sensors (terminals J3-J6) and the computer  112  (for selecting the mode of operation via terminals J8 and J9). The sensor hardware schematic  210 , including the header  200 , is shown in  FIG. 9  in more detail. Referring to  FIG. 9 , the terminals J1-J12 of header  200  are electrically coupled to the ports of the controller  120  as specified in TABLE II. A first variable resistor RV 1  comprises the resistance of the position sensor  106  ( FIG. 3 ) and a second variable resistor RV 2  is used to match the resistance to create a voltage divider as previously described, to form a potentiometer, used with the position sensor  106  ( FIG. 3 ). 
         [0054]    In an alternative embodiment of the sensor hardware of  FIG. 9 , it is contemplated that the expansion terminals J5-J7 may be used for additional sensors, including blood pressure, heart rate, and stress indicators. To accomplish this, the sensor bus is modified to use both 3.3 and 5.0 volt supply lines to allow for the plug-in of multiple expansion sensors. With a selectable supply voltage, a universal connector is provided for both patient data acquisition in the treatment mode and for data transmission to the doctor&#39;s office in the data transmission mode selected by cable. 
         [0055]    Referring to  FIG. 3 , the temperature sensor  108  is a Dallas Semiconductor LM34DZ temperature sensor. This temperature sensor was not used to measure the patient&#39;s actual temperature but was used to confirm that the patient was actually using the device. 
         [0056]    With reference to  FIG. 3 , the patient monitoring system software running on the computer  112  briefly will be described. The software application provides a therapist a way of obtaining the data stored on the data acquisition unit  104  and presents it in a meaningful way. One function of the Patient Monitoring System software is the ability to view patient records. The system checks to ensure that all fields are entered and informs the user if one or more of the fields are blank. In addition, the system checks the patient name entered against the array of current patient names. If the entered name is invalid, the system reports no patient found. Otherwise, the system uses the “Patient ID” field from the array to access the data file for that particular patient. This file contains all of the information obtained from the data acquisition unit ( FIG. 3 ) from previous visits. The system then displays the contents of the file in the grid at the bottom of the form. The grid is another built-in control of Visual Basic 6.0 called the “Microsoft FlexGrid Control 6.0”. In addition, the system displays other patient information such as the name of that patient&#39;s physician and the date that patient received their orthosis device. 
         [0057]    Another function provided by the system software is the form for actually acquiring data from the data acquisition unit  104  ( FIG. 3 ). The screen layout is very similar to that of the form for viewing patient records that are already stored in the system. This form also uses a grid to display the data once it has been obtained from the Data Acquisition Unit. In order to facilitate reading from a communications port, Visual Basic has a control entitled “Microsoft Comm Control 6.0”. This control allows communication between the personal computer  112  ( FIG. 3 ) and any device attached to a designated communications port. The user also has the option to change what communications port the system will look for the data acquisition unit on in case other communications ports are already in use by that individual&#39;s computer. By default, this is set to COM1. 
         [0058]    When the user clicks on the “Acquire” command button, as in other forms, the system checks to see first if all proper text fields have been filled in, and then if the patient name entered is valid. Also, it informs the user to make sure that the data acquisition unit is securely connected to the selected communication port. Next, the system sends out a zero byte on the communication port, which informs the data acquisition unit to begin sending data. The patient monitoring system software then reads in the raw data from the unit, one byte at a time, and stores it into a temporary file called “output.dat”. After the data acquisition unit has completed sending all of its data, the system software sends out a byte equal to 0xFF in hexadecimal to inform the data acquisition unit to wipe out its memory and the serial communication is complete. 
         [0059]    The next major task that the software application does involves manipulating data. This includes converting the raw data obtained from the data acquisition unit into meaningful values, saving them in the proper patient&#39;s file, and displaying them in the grid for the user to examine. First, the system goes through and converts all of the data received from the data acquisition unit into actual integers, instead of the binary form that they are initially sent in. The first major changing of any data occurs with the data representing the time and the date. Actually, the date is composed of a byte representing the month, and one representing the day. The data acquisition unit transmits all three of these values: month, day, and hour, in BCD form (see TABLE I). To do this, the system subtracts a factor of six from the data based on the value of its upper four bits. For example, the BCD value of thirty-one is stored in binary as 0011 0001. The system will subtract eighteen (six times the value of the upper four bits, three) from the integer value of the number, forty-nine, to produce the correct result of thirty-one. 
         [0060]    The next major conversion occurs with the “Position” readings taken by the position sensor  106  ( FIG. 3 ) and transmitted from the data acquisition unit  104 . The data acquisition unit transmits values called Stretch_Min and Stretch_Max during its serial communication with the patient monitoring software. The difference between these two numbers is computed and adjusted to fit a scale of based on the particular device. For example, a one orthosis device allows a range of motion from one hundred thirty-eight to negative ten degrees. Next, each “Position” value is then adjusted accordingly to fit within these two values. In reality, this conversion may not be exactly linear, but since the position sensor need not be as highly accurate as other more expensive models, assuming linearity in this case is acceptable. 
         [0061]    The final conversion that the system makes involves the readings from the temperature sensor  108  (see  FIG. 3 ). Based on the specifications of the temperature sensor itself, the voltage increases ten milivolts per degree. The system then fits the binary data into the range of acceptable values. For the most part, the temperature data should be relatively constant. Its primary purpose is to ensure that the patient is actually wearing the device while using it, instead of simply turning it on to take false readings. As a result, the therapist would be able to tell if a reading was false by seeing if any of the temperature values were conspicuously above or below any realistic, expected values. This helps to ensure proper adherence to the stretching protocol. 
         [0062]    In  FIG. 10  an alternative embodiment of the monitoring system  100  shown in  FIG. 3  is shown. In this alternative embodiment, the device type sensor  110  shown in  FIG. 3  is used. Although shown in  FIG. 3 , the sensor  110  was not used in the first embodiment, in that the device ID was downloaded by the application software operating on the computer  112  to the data acquisition unit  104 . But in this alternative embodiment, the device ID is obtained via the sensor  110 . Referring to  FIG. 10 , each orthosis device is given its own unique resistor R 2 . Typically, this resistor is mounted on orthosis separate from the data acquisition unit  104 , so that the data acquisition unit  104  is not device specific. In the case of the orthosis  10 , the resistor R 2  enclosed in a protective casing and the casing is mounted to one of the arms  22  or  40 . The resistor R 2  is electrically coupled on one side to a lead  210  extending from the casing and is electrically coupled at its other side to ground. The lead  210  is connected to the first expansion terminal J5 shown in  FIG. 9 . The device sensor  110  includes additional circuitry located within the data acquisition unit  104 . This additional circuitry includes a node  212 , a capacitor C (having a value of 0.1 uF) electrically coupled between the node  212  and electrical ground, a resistor R 1  electrically coupled between the node  212  and a voltage source Vcc and a 10 bit Analog-to-digital converter (ADC)  214  connected to node  212 . 
         [0063]    When the node  212  is electrically coupled to the lead  210  of the resistor R 2 , the resistor R 2  and Care in parallel. The voltage VADC applied to the ADC  214  is as follows: 
         [0000]    
       
         
           
             VADC 
             = 
             
               
                 ( 
                 
                   
                     R 
                      
                     
                         
                     
                      
                     2 
                   
                   
                     
                       R 
                        
                       
                           
                       
                        
                       2 
                     
                     + 
                     
                       R 
                        
                       
                           
                       
                        
                       1 
                     
                   
                 
                 ) 
               
                
               
                 ( 
                 Vcc 
                 ) 
               
             
           
         
       
     
         [0064]    In this case the following conditions apply: no cable resistance, so that when R 2 =infinity, V ADC =Vcc; for the PC link cable, when resistor R 2 =0, then V ADC =0 and that there is a valid orthosis device with an embedded resister R 2 . In this case, the resolution of this device sensor  110  at Vcc=5V would be 210=1024, so that  5 / 1024  =SmV. The following TABLE III provides illustrative values used to identify different orthosis devices (R 2  is provided in kilo ohms, V ADC  and Range are provided in volts, and R1=10 kilo ohms): 
         [0000]    
       
         
               
               
               
             
               
               
               
             
           
               
                 TABLE III 
               
               
                   
               
               
                 Device - R2 
                 V ADC   
                 Range 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 440 
                 4.89 
                 4.85-4.91 
               
               
                 150 
                 4.76 
                  4.7-4.82 
               
               
                 100 
                 4.54 
                 4.45-4.65 
               
               
                 50 
                 4.17 
                 4.09-4.35 
               
               
                 32 
                 3.8 
                 3.61-4.06 
               
               
                 18 
                 3.21 
                 2.96-3.54 
               
               
                 10 
                 2.5 
                 2.23-2.95 
               
               
                 5.8 
                 1.83 
                 1.59-2.2  
               
               
                 3.3 
                 1.24 
                 1.05-1.55 
               
               
                 1.8 
                 0.96 
                 0.63-1.0  
               
               
                 1.0 
                 0.45 
                 0.37-0.6  
               
               
                 0.5 
                 0.238 
                 0.195-0.55  
               
               
                 0.28 
                 0.136 
                 0.110-0.18  
               
               
                   
               
             
          
         
       
     
         [0065]    As discussed above, this alternative embodiment is utilizable where it is desirable to identify a given orthosis device out of a plurality of possible orthosis devices so as to eliminate the need for downloading parameters, commands and/or firmware for that specific orthosis device. In other words, like the use of the temperature sensor, the orthosis devices making use of this embodiment of the monitor  100  do not need to be directed toward those implementing stretching exercises. 
         [0066]    An additional feature that may be added to the Patient Monitoring System software is a “non-programmers” interface wherein a Microsoft® Windows based graphical user interface (GUI) is provided with a plurality of predetermined unit configurations for the monitor system  100  of  FIG. 3  are provided in a first window. The user is able to select one of these unit configurations by clicking on the same and dragging the same to a selection window. This feature allows for unit configuration by a therapist or family configuration by an Original Equipment Manufacturer (OEM) without the need for factory assistance. Additionally, a third window may be provided wherein the user may select other system or user variables, by once again dragging the same from the third window to the selection window. 
         [0067]    Referring to  FIG. 3 , aspects of the monitor system  100 , such as the device type detector  110  ( FIG. 3 ), may be used with devices other than the stretching orthosis shown by the illustrative embodiment of  FIG. 6 . Other possible applications for these aspects would be to other types of orthosis devices, such as isometric orthosis devices. Via software, the monitor system  100  may be configured to work with any rehabilitation device having position measurements. The monitor also has the ability to accept other sensor inputs not accounted for previously. The firmware and hardware of the monitor system  100  already provides for the possibility of up to 5 sensor inputs, thus only minor changes in the PC software are necessary in order to view data output from other sensor inputs, such as mentioned with respect to  FIG. 9 . 
         [0068]    After thorough testing of the data transfer capabilities of the monitor  102 , it has been concluded that a higher crystal frequency may be more suitable for transmitting the required data over the RS-232 port. Operating the micro-controller at 20 MHz would significantly decrease the data transfer time and would not add much to the cost of the product, but allow the I2C bus to operate in high speed mode as well as allow a higher baud rate for the RS-232 communications. 
         [0069]    Having a spring measure the amount of extension/flexion may be a very cost-effective solution for the position sensor  106  of  FIG. 6 ; however, those skilled in the art will recognize that more accurate position sensors may be used. 
         [0070]    While various values, scalar and otherwise, may be disclosed herein, it is to be understood that these are not exact values, but rather to be interpreted as “about” such values. Further, the use of a modifier such as “about” or “approximately” in this specification with respect to any value is not to imply that the absence of such a modifier with respect to another value indicated the latter to be exact. 
         [0071]    Changes and modifications can be made by those skilled in the art to the embodiments as disclosed herein and such examples, illustrations, and theories are for explanatory purposes and are not intended to limit the scope of the claims. For example, one embodiment of the disclosure has been described as utilizing cables to transfer data. In this regard, the data transfer can be implemented using fiber optics, a phone line, a cellular phone link, an RF link, and/or other communications channels. Thus, the present disclosure also envisions the use of wireless means for data transfer. Such wireless means could use technology like the CENTRINO mobile technology and personal digital assistants (PDA&#39;s). 
         [0072]    Furthermore, the disclosure has been described as being used by patients and health care professionals. However, limited access to the system and/or data by others could be allowed if authorized by the patient and/or health care professional. On such scenario in which limited access could be granted would be for proof of assurance to an insurance company for a worker&#39;s compensation carrier. Others may also have a need to have some assurance that a patient is indeed following through with a compliance protocol. 
         [0073]    Although the monitoring system and method have been described primarily in the context of an orthosis device, other applications are contemplated by the present disclosure. These include other aspects of physical therapy; electrostimulation; bone growth stimulation; drug delivery systems; cardiac rehabilitation; generalized rehabilitation, including compliance; implantable pumps, such as insulin pumps for diabetics; intravenous or implantable pump medication; and implantable or wearable chemical sensors to monitor various physiological parameters such as blood coagulation, blood profile, and blood enzyme content. 
         [0074]    For example, in known pharmaceutical delivery systems, a rotatable wheel has a number of compartments, each containing an incremental dose of medications. As programmed, a door opens at a prescribed time and the pill either by weight or by size would be opened up for patient access. 
         [0075]    With the present disclosure, we can externally monitor these drug deliveries systems or internally monitor them. The delivery systems could be used with an implantable pump or implantable blood chemistry sensor. A wireless readout from the pump or sensor could attach, for example, to a wrist watch which would monitor the compliance through a digital readout. A patient could monitor their own blood chemistries or response to particular medications and then these results would be broadcast to physician, extended care, nurse practitioner, nurse, insurance carrier, etc. This would then monitor the changes to a specific drug and then monitor the serum chemistries, for example, blood sugar, etc. These are monitored and then the patient can be monitored through a wireless format to see how they respond to certain medications and have an instant readout through this chemistry monitor without actually having the patient in the office or in the hospital. If the response is not as desired, the delivery protocol can be remotely changed based on the measurements. 
         [0076]    In light of the foregoing, it should be understood that while various descriptions of the present disclosure are described above, the various features could be used singly or in any combination thereof. Therefore, this disclosure is not to be limited to only the specifically preferred embodiments depicted herein. 
         [0077]    Further, it should be understood that variations and modifications within the spirit and scope of the disclosure might occur to those skilled in the art to which the disclosure pertains. Accordingly, all expedient modifications readily attainable by one versed in the art from the disclosure set forth herein that are within the scope and spirit of the present disclosure are to be included as further embodiments of the present disclosure. The scope of the present disclosure is accordingly defined as set fmih in the appended claims.

Technology Classification (CPC): 8