Abstract:
This invention relates to a system that continuously monitors pressure and force on the foot, analyzes and visualizes the pressure and force exerted on said foot in real-time. The invention measures pressure and force applied to a plurality of sensors placed in various points of an orthotic, shoe, shoe lining, insert, sock or sock type device. If the sensors detect pressure or force, the sensors send a signal to a microcomputer processor located in the shoe that subsequently analyzes and sends the data wireless to either a handheld electronic device, a personal computer, an electronic data capture system or a software program. The handheld electronic device or the personal computer then displays the data to an operator of the device or computer instantaneously; while the data capture system or program forwards the information to a handheld device and/or personal computer.

Description:
[0001]    This application claims the benefit of U.S. Provisional Patent Application No. 60/864,050 filed on Nov. 2, 2006, entitled “PRESSURE ALERT SENSING SYSTEM” which is expressly incorporated herein in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Disclosure 
         [0003]    The present disclosure generally relates to a system for sensing and alerting a user to pressure and force on his foot. 
         [0004]    2. Description of the Related Art 
         [0005]    Diabetics and other afflicted people with medical problems can have failures in the nervous system. This could be detrimental to their health since they often do not recognize pain, discomfort, irritation, changes in pressure, swelling, changes in temperature or have an inability to recognize pain, discomfort, irritation, changes in pressure, swelling, or changes in temperature to a sufficient degree to prevent injury, or illness to themselves. This is especially prevalent in the feet of the afflicted person with failure(s) in their nervous system since their feet are susceptible to increased pressure, irritation, changes in pressure, swelling, or changes in temperature while standing, sitting or lying down. Thus, an afflicted person may place too much pressure on a foot or a portion of a foot by physical activity, by standing or even while sitting or lying down. This is problematic because too much pressure on the foot or a portion of the foot could cause increased nerve damage to the foot, destruction of the skin creating an open wound, or a host of other ailments. Thus, there is a need for a low-cost system to alert the user to problematic pressure, and other physiologic and biomechanical changes to their foot or feet along with continuous active monitoring of the changes in pressure and other physiologic and biomechanical changes being applied to their foot or feet. 
       BRIEF SUMMARY OF THE INVENTION 
       [0006]    The present invention is a system for sensing and alerting a user to changes in pressure and force upon a foot during resting, sitting , standing or exercise, like walking, by using footwear having a plurality of primary pressure sensors, a medical node connected to the plurality of primary pressure sensors, and a base station connected to the medical node. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]    The exact nature of this invention as well as other objects and advantages thereof will be readily apparent from consideration of the following specification in conjunction with the accompanying drawings in which like numerals designate like parts through the figures thereof and wherein: 
           [0008]      FIG. 1  is a block diagram illustration of footwear with pressure sensors; 
           [0009]      FIG. 2  is a block diagram illustrating an alternative embodiment of the invention as footwear; 
           [0010]      FIG. 3  is a block diagram illustrating another alternative embodiment of the invention as footwear; 
           [0011]      FIG. 4  is a block diagram of a preferred embodiment of a system of the present invention; 
           [0012]      FIG. 5  is an abstract illustration of a screen of a base station; and 
           [0013]      FIG. 6  is a pictorial illustration of a preferred embodiment of a system of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0014]      FIG. 1  is a block diagram illustration of footwear  4  with pressure sensors  8 . Footwear  4  may be a removable insert for a shoe as illustrated. Footwear  4  may also be a shoe, a sandal, a sock, sock type device, a boot, or a non-removable insert, an orthotic, shoe lining, etc. Footwear  4  contains a plurality of pressure sensors  8  connected by connections  16  to a medical node  6 . 
         [0015]    Pressure sensors  8  may be resistive pressure sensors, but are not limited to resistive pressure sensors and can be a variety of other types of pressure sensors as well as other physiological and biomechanical sensors. In either case, medical node  6  receives raw data from pressure sensors  8  and generates pressure data for transmission to a first base station  10  ( FIG. 4 ). Although  FIG. 1  only depicts five pressure sensors, it is understood that the number of pressure sensors may vary. As many pressures sensors as needed are contemplated. 
         [0016]    Medical node  6  can be, for example, a MediSens MedNode™. Medical node  6  has a transmitter (not shown) and a microprocessor (not shown). The microprocessor allows the medical node  6  to process the raw data from pressure sensors  8  to generate the pressure data. The transmitter is used to transmit the pressure data to the first base station  10 . 
         [0017]    If footwear  4  is a shoe, a sandal, or a boot, medical node  6  and sensors  8  do not need to be in the general area where the foot applies pressure on pressure sensors  8 . For example, medical node  6  and sensors  8  could be in the tongue of the shoe, or on the straps of a sandal, or in the walls and lining of a boot or shoe. 
         [0018]    In operation, Pressure sensors  8  sense pressure from a foot placed on them. Where pressure sensors  8  are resistive sensors, the resistance in primary pressure sensors  8  varies as different pressure and/or force is applied to them. Medical node  6  sends current through pressure sensors  8  and determines the pressure at each pressure sensor  8  from the resistance detected. 
         [0019]      FIG. 2  is a block diagram illustrating an alternative embodiment of the invention as a footwear  4 . In  FIG. 2 , footwear  4  is an insert for a shoe. Instead of only one type of pressures sensors, however, there are two types of pressure sensors, primary pressure sensor  8   a  and secondary pressures sensors  8   b . Each primary pressure sensor  8   a  is surrounded by secondary pressure sensors  8   b . When medical node  6  detects that the primary pressure sensor  8   a  is defective or fails, it activates one or more of the secondary pressure sensors  8   b . The medical node can receive raw data from the secondary pressure sensors  8   b  instead of primary pressure sensor  8   a . This allows the medical node to still receive raw data in the approximate location of primary pressure sensor  8   a  without using primary pressure sensor  8   a . The medical node can compensate for the location differences between primary pressure sensor  8   a  and secondary pressure sensors  8   b . Primary pressure sensor  8   a  can be determined to be defective or failed if it returns the same raw data for a predetermined period of time. Primary sensor  8   a  can also be determined to be defective or failed if it returns wildly erratic raw data that varies from high to low in a short period of time. 
         [0020]    The secondary pressure sensors  8   b  could be less expensive than the primary pressure sensor  8   a . Secondary pressure sensors  8   b  could also remain dormant and only be active when activated so as to not unnecessarily draw power. Although  FIG. 2  depicts four secondary pressure sensors  8   b  surrounding a primary pressure sensor  8   a , it is understood that the number of secondary pressure sensors  8   b  could vary. There could be one, two, seven, or even eight or more secondary pressure sensors  8   b  for each primary pressure sensor  8   a . Furthermore, it is unnecessary for every primary pressure sensor  8   a  to have secondary pressure sensors  8   b  surrounding it. In addition, is also unnecessary for every primary pressure sensor  8   a  to have the same number of secondary pressure sensors  8   b  surrounding it. 
         [0021]    It is also contemplated that some or all of the secondary pressure sensors  8   b  could be activated even when primary pressure sensor  8   a  has not failed or is not defective. This could be beneficial when more pressure data is necessary such as when fine analysis is required for pressure on the foot. 
         [0022]      FIG. 3  is a block diagram illustrating another embodiment of the invention as footwear. In  FIG. 3 , footwear  4  is an insert for a shoe. Instead of only one type of pressures sensor, however, there are two types of pressure sensors, primary pressures sensors  8   a  and secondary pressures sensors  8   b . As can be seen, primary pressure sensor  8   a  has secondary pressure sensor  8   b  placed on top of it. When medical node  6  detects that primary pressure sensor  8   a  is defective or fails, it activates secondary pressure sensor  8   b . Thus, medical node  6  can receive raw data from the secondary pressure sensors  8   b  instead of primary pressure sensor  8   a . This would allow the medical node to still receive raw data in a location of primary pressure sensor  8   a  without using primary pressure sensor  8   a . However, there would be a depth difference since primary pressure sensor  8   a  would not be at the same depth as secondary pressure sensor  8   b . Medical node  6  can compensate for the depth differences between primary pressure sensor  8   a  and secondary pressure sensor  8   b . Primary pressure sensor  8   a  can be determined to be defective or have failed if it returns the same raw data for a predetermined period of time. Primary sensor  8   a  can also be determined to be defective or have failed if it returns wildly erratic raw data that varies from high to low in a short period of time. 
         [0023]    As shown in  FIG. 4 , the present invention includes a system  2  for sensing and alerting a user to pressure on his foot  12 . 
         [0024]    Instead of or in addition to medical node  6 , first base station  10  and/or second base station  20  could also determine if primary pressure sensor  8   a  is defective or has failed as shown in  FIGS. 4 and 6 . First base station  10  and/or second base station  20  could also update software within medical node  6  such that medical node  6  could compensate for the difference in depth or location between primary pressure sensor  8   a  and secondary pressure sensors  8   b . Alternatively, first base station  10  and/or second base station  20  would compensate for the difference in depth or location between primary pressure sensor  8   a  and secondary pressure sensor  8   b  by altering its analysis of the pressure data received from medical node  6 . 
         [0025]    Secondary pressure sensor  8   b  could be cheaper to manufacture, obtain, and/or implement than primary pressure sensor  8   a . Secondary pressure sensors  8   b  could also remain dormant and only be active when activated so as to not unnecessarily draw power from battery  24 . Although  FIG. 3  depicts a single secondary pressure sensor  8   b  on top of primary pressure sensor  8   a , it is understood that the number of secondary pressure sensors  8   b  could vary. Thus, there could be one, two, seven, or even eight or more secondary pressure sensors  8   b  for each primary pressure sensor  8   a . Furthermore, not every primary pressure sensor  8   a  needs to have a secondary pressure sensors  8   b  on top of it. In addition, it is unnecessary for every primary pressure sensor  8   a  to have the same number of secondary pressure sensors  8   b  on top of it. Furthermore, the location of the secondary sensor  8   b  could vary, such that it could be on bottom of the primary pressure sensor  8   a.    
         [0026]    It is also contemplated that some or all of the secondary pressure sensors  8   b  could also be activated even when primary pressure sensor  8   a  has not failed or is not defective. This could be beneficial when more pressure data is necessary such as when fine analysis is used for the pressure on his foot. 
         [0027]    System  2  has a footwear  4  such as one illustrated in  FIGS. 1 ,  2 , or  3 . Footwear  4  has a plurality of pressure sensors  8  which receive pressure when the foot  12  physically contacts  18  the pressure sensors  8 . The plurality of pressure sensors  8  are connected to medical node  6  through connection  16 . A battery  24  is connected to medical node  6 . Although only one footwear or shoe  4  is shown, the present system has equal application to more than one shoe. 
         [0028]    Battery  24  preferably has a minimized physical presence and weight. Battery  24  can be a rechargeable and removable battery. In the situation where battery  24  is a rechargeable and removable battery, medical node  6  can detect when battery  24  is low on power such that it needs to be removed and recharged. Furthermore, battery  24  can also be recharged through the movements of footwear  4  such as when footwear  4  is inserted in a shoe or is a shoe itself. In such a situation it is unnecessary for battery  24  to be removable. Although not shown, a back-up battery can also be included. 
         [0029]    First base station  10  is connected to footwear  4  by a connection  14 . Connection  14  is a wireless connection in  FIG. 4 , but could also be a wired connection. As a wireless connection, connection  14  could be an Internet connection, a Bluetooth connection, a telephone signal, etc. 
         [0030]    First base station  10  is a computer, but it can also be any other type of electronic device such as a mobile phone, a blackberry, an iPhone, an iPod, etc. First base station  10  can also be an intermediate communication module such as a monitoring station designed to receive and transmit pressure data which allows the medical node  6  to only transmit pressure data to first base station  10 . If first base station  10  is an intermediate communication module, it may have a more powerful transmitter to relay the pressure data to a more distant location to a second base station  20 . Battery  24  connected to medical node  6  may thus be reduced in size, reducing costs, and allowing for a greater degree of portability of footwear  4 . 
         [0031]    First base station  10  can also have a storage device  26  to store the pressure data from the medical node  6 . First base station  10  can then use and/or analyze the pressure data to generate useful analysis of the pressure data in the form of X-Y charts based on time and pressure. For example, this could be helpful in detecting problems the user has with placing pressure on his feet and allowing the user to correct such problems. 
         [0032]    Furthermore, first base station  10  could also have an optional display  30  as shown in  FIG. 5 . 
         [0033]    A second base station  20  may be connected to the first base station  10  by a connection  22 . Second base station  20  is preferably a computer. It can also be any other type of electronic device such as a mobile phone, a blackberry, an iPhone, an iPod, etc. Second base station  20  may be located remotely from first base station  10 . The user of first base station  10  need not be the same as the user for the second base station  20 . The user of the second base station  20  could be a doctor, physician, nurse, or family member, for example. This allows different people to access the pressure data generated by medical node  6 . 
         [0034]    In operation, foot  12  from a user is placed over footwear  4 . The foot  12  applies pressure to footwear  4  through physical contact  18  with the pressure sensor, such as when the user steps on footwear  4 . Pressure sensors  8  ( 8   a  and/or  8   b ) detect the pressure being applied by foot  12  and transmit the raw data to medical node  6 . Medical node  6  receives the raw data from pressure sensors  8  ( 8   a  and/or  8   b ) through connection  16  and generates pressure data from the raw data. 
         [0035]    Medical node  6  transmits the pressure data to a first base station  10  through connection  14 . First base station  10  receives the pressure data from medical node  6  and analyzes the pressure data. First base station  10  can also optionally transmit the pressure data to second base station  20  through connection  22 . 
         [0036]    When first base station  10  analyzes the pressure data, it may generate an event alert if a predetermined event occurs. A predetermined event occurs when the pressure data indicates that there is pressure above a predetermined level and for longer than a predetermined time period at one or more of the primary pressure sensors. This potentially prevents a user from putting too much pressure on a certain portion of his foot  12 , preventing the user from cutting off circulation to a portion of his foot and/or destroying the skin and other surrounding tissue structures of the foot. The present invention is designed to help prevent serious damage to a foot structure leading to possible amputation of his foot or afflicted extremity. 
         [0037]    When first base station  10  generates an event alert, it sends a text message, page, voice mail or e-mail to the user. First base station  10  can also send auditory signals in addition to other visual or vibratory signals to the user. 
         [0038]    As shown in  FIG. 5 , first base station  10  has an optional display  30  showing a simulated image  32  of a user&#39;s foot. Points  28  correspond to locations of primary pressure sensors  8  ( 8   a  and/or  8   b ). When pressure is applied on foot  12  and is detected by primary sensors  8  ( 8   a  and/or  8   b ), points  28  may change colors to indicate the amount of pressure on a user&#39;s foot  12 . The color of points  28  could be the foot&#39;s natural color if there is normal pressure and/or force, but the color of points  28  could change to red if there is high pressure and/or force. 
         [0039]    Display  30  also indicates the user&#39;s information such as his ID number, age, height, weight, etc. It also has a section  34  to allow the user to input his phone numbers and/or check to see if the user wants to automatically send a text message, or other alert media if there is a predetermined event. Section  34  of display  30  can also be used to input multiple phone numbers such as the mobile phone number of a doctor or family member. Section  34  may also be used to input a user&#39;s e-mail address or other e-mail addresses in which case first base station  10  can automatically send an e-mail to the appropriate person when there is a predetermined event. Section  34  may also be used to generate event alerts to a variety of other devices such as a personal digital assistant, iPod, or other handheld or worn electronic device when a predetermined event occurs. 
         [0040]    First base station  10  may also be used to alter the functionality of medical node  6  and pressure sensors  8  ( 8   a  and/or  8   b ). For example, the following alterations to medical node  6  can be performed:
       Reconfiguration of data accusation procedure like change of sampling rate;   Alteration between sensors: switch to primary pressure sensors  8   a  or secondary pressure sensors  8   b  as shown in  FIGS. 2 and 3 ;   Reconfiguring fault tolerant coding techniques: Switch to more/less reliable coding of the sample data for transmission to first base station  10 ;   Change precision and accuracy by adjusting supply voltage and quantization factors in an Analog to Digital Converter (“ADC”);   Rerouting the links among the sensors and transceivers; and   Modification in raw data processing including but not limited to filtering and noise reduction.       
 
         [0047]    When first base station  10  is communicating with medical node  6  to retrieve data or calibrate medical node  6 , first base station  10  and medical node  6  can communicate with a level of security. While it is important to protect medical data, it is also important to minimize cost and realize the limitations of battery  24 . Thus, first base station  10  can choose the sophistication of the security used when communicating with medical node  6 . 
         [0048]    For example, if there are four levels of security possible, with the first security level being the lowest form of security and the fourth security level being the highest form of security, if the situation is urgent, first base station  10  could choose the first security level or lowest form of security. However, if the situation is not urgent, first base station  10  could choose the fourth security level or the highest form of security. A non-urgent situation could be when the user is walking around performing ordinary daily tasks. In that case, the desired security level would be high since the user would want to protect his medical data but has no pressing need to retrieve the pressure data as soon as possible. An urgent situation could be when there is a predetermined event that requires immediate attention. In that case, the desired security level would be minimal since although the user would want to have some form of protection for his medical data, the need to retrieve the pressure data and act on it as soon as possible is more important. 
         [0049]    In one contemplated embodiment, the first level of security is plaintext. The second level of security would be authentication only and a type of cipher block chaining would compute and verify the message integrity. The third level of security would have authentication and encryption with Skipjack cryptography. The fourth level of security would have authentication and encryption with RC5 cryptography. It is contemplated that the authentication and encryption necessary for each level of security is changeable as well as having more or less levels of security. 
         [0050]    The components of the present invention including first base station  10 , second base station  20 , medical node  6 , and/or primary pressure sensors  8  ( 8   a  and/or  8   b ) can be calibrated. To calibrate the present invention, two types of pressure data are used. First is the amount of whole pressure applied to a foot. Second is the pressure sensed at designated points of the foot such as points where the foot touches the shoe or ground. The pressures sensed can be a variety of types of forces such as shear force. This pressure data will be used to measure and assess the correct pressure. When the user uses footwear  4  for the first time, the present invention will calibrate and get the initial and balanced condition&#39;s pressure such as designated points of the foot and the whole foot. 
         [0051]    The total pressure sensed from both feet in the calibration state will be used as a parameter for comparison purposes in the future detection of pressure on the foot. In those instances where only one foot is involved parameters for comparison will be derived from the average norm of similar patients with the same condition, as well as from the patient&#39;s previous calibrated states. When the calibration is done, the present invention will consistently receive the data from medical node  6 , compute the pressure and report the possible percussions based on the following: 
         [0052]    1.) Patient is not moving: In this case the present invention will take the whole pressure sensed from both feet. By comparing the relation between the amount of total pressure applied by each foot, or the average norm in the case of one foot, and the pressure active area with the calibrated data, the present invention can detect if the foot with the higher pressure is projecting the correct amount of pressure or not, or if both feet (or foot) are being subjected to excessive pressure as in the case of excessive lower extremity edema. For example if the user is leaning to the left, he puts all of his weights on the left foot while the right foot is still on the ground. In this case the amount of pressure applied to the right foot will be less than normal but the active area is unchanged. However the left medical node will sense more pressure and the active area will be focused in the outer side of the foot. In this case the present invention will compute the pressure based on active area in each shoe and will compare the results with the calibration result. It will then make a decision, such as whether a predetermined event has occurred, based on the comparison. 
         [0053]    2) Patient is moving: Movement can be detected as extreme changes in the locality of the pressure applied in foot. For example, pressure will be from the right foot to left foot and from the heel to the toe. The present invention will analyze the data in fixed time intervals. In each time interval the present invention will analyze pressure data received from each footwear  4  similar to when the patient is not moving and first places the footwear  4  or shoe on. 
         [0054]    Furthermore, calibration can also be done automatically on medical node  6  each time the shoelace tightness is altered or other events which might alter the analysis of pressure data. Also, since the detected pressure is a function of human mass and the area where the force is applied, the present invention can also be used for measuring the user&#39;s weight. 
         [0055]    As shown in  FIG. 6 , a foot  12  places pressure on footwear  4 . Pressure sensors  8  ( 8   a  and/or  8   b ) transmit raw data to medical node  6 , which in turn generates pressure data and transmits it to base station  10  via connection  14 . In this embodiment, base station  10  is a mobile phone and connection  14  is a Bluetooth connection. Base station  10  then transmits the pressure data to base station  20  through a wireless connection  22 . In this embodiment, base station  20  is a laptop computer and connection  22  is a cellular connection. However, connection  22  can be other types of connections such as a satellite connection. 
         [0056]    Although not shown, footwear  4  could also have temperature sensors connected to medical node  6  to ascertain the temperature of a foot. Alternatively, the pressures sensors  8  ( 8   a  and/or  8   b ) could be configured to sense temperature, too. In addition, footwear  4  could have sensors for the heart rate of a user, galvanic skin response, precipitation, or oximetry, for example. Footwear  4  could also contain an accelerometer. 
         [0057]    Obviously many modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims the invention may be practiced otherwise than as specifically described.