Abstract:
The invention describes a device and a method for examining the sole of a foot. This invention can be used, for example, for the early detection of neuropathy and/or small wounds on the sole of the feet of diabetic patients. The device comprises a sending means for transmitting images of the sole to, for example, a doctor in a hospital. This enables rapid and simple recording of an image of the sole at home, and using relatively simple means, its transmission to, and examination by an expert at a remote location.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     1. Field of the Invention  
         [0002]     The invention relates to a device, a system and method for checking a diabetic foot. The invention relates in particular to a device for recording an image of the sole of a foot, comprising image-recording means for creating an electronic image of the sole of the foot.  
         [0003]     2. Description of the Background Art  
         [0004]     Approximately 15% of diabetic patients sustain a foot wound at one time in the course of their disease and such wounds are often chronic and difficult to treat. Diabetic patients often have little or no sensation in their feet. This phenomenon is known as “diabetic foot.” If not identified in time, the tissue damage in a foot wound of a subject, particularly a diabetic patient, can be so extensive as to require amputation of the leg. Indeed, 40-70% of all lower leg amputations are performed on diabetics. Early identification and treatment of foot wounds in such subjects is therefore very important.  
         [0005]     Recording systems for analyzing a diabetic foot generally use pressure sensors to detect problems. German Patent Publication DE 4337608A1 discloses a system utilizing pressure sensors. The values measured by the pressure sensors are sent to a computer for analysis. Such a device is relatively expensive requires expertise for operation, making it suitable only for use in a clinic or hospital. Moreover, such a measuring apparatus is not suitable for detecting small wounds.  
         [0006]     A device described in PCT Publication WO 91/17708 comprises a computer and a visual display unit for examining measured results which include information on the curvature of the sole of the foot. Such measures are employed for the design and production of a suitable shoe sole. The recorded image of the sole is converted into a contour map, but the image, as such, is used no further.  
       SUMMARY OF THE INVENTION  
       [0007]     The present invention is directed to device, system and method that enables recording of an image of the sole of a foot in a subject, preferably while the subject is at home. This relatively simple device provides a means for having a remotely situated expert collaborate in the detection/diagnostic process without requiring the subject to go to the expert.  
         [0008]     To that end, the present invention provides a device of the type described herein, and in the appended drawings, that comprises sending means for sending the electronic image to a remote monitor.  
         [0009]     In a preferred embodiment, the device contains no sensors, but only image-recording means, for recording an image of the sole of the foot. Sending the electronic image enables remote monitoring, for example by a doctor, who can examine the sole of the foot and take any necessary action. Sending images regularly ensures monitoring over time so that any changes such as deterioration in the condition of the sole can be detected in time.  
         [0010]     The device preferably comprises a transparent support surface, for supporting a foot. A subject can easily place his/her feet on the support surface, after which a image of the sole is made.  
         [0011]     In one embodiment the electronic image comprises or can be converted to a color photograph or of the sole of the foot. Color information is desirable during the examination of diabetic feet.  
         [0012]     In another embodiment the device comprises a connection for a television and/or a computer. In this case a subject can himself/herself view an image using commonly available equipment, such as a TV set or a personal computer.  
         [0013]     Diabetic patients often have impaired vision, so that the image-recording means in one embodiment of the invention comprises tuning means to permit zooming in on, or zooming out from, the sole of the foot. With this device, a monitor can study the sole in great detail, making early detection of a small wounds more likely.  
         [0014]     In a further embodiment the device comprises a regulating means, which is designed to communicate with the image-recording means, in order to control the image-recording means remotely. The regulating device can be, for example, a remote control, the use of which enables a subject standing on the device or resting a foot on the device&#39;s recording surface to control the zooming in or out of the image, and/or the recording and transmission of an image.  
         [0015]     In a further embodiment the transparent supporting surface is placed on a box-shaped construction containing the image-recording means. In this way the device is very practical because the image-recording means is protected.  
         [0016]     In one embodiment the device includes switching means, which is designed to activate the image-recording means after pressure has been exerted upon the supporting surface. All a subject now has to do is place a foot or feet on the device and a image of one or both soles will be acquired.  
         [0017]     In a preferred embodiment the sending means is designed for sending a digital copy by way of a digital network, such as the Internet. The sending means comprises, for example, a modem for sending digital signals via telephone line. An image can then be sent, via the Internet for example, directly to a doctor or another suitable person. This can spare the subject the need to visit the doctor. It will be clear that the modem can be a wireless or telephone modem. In this case, the device is a stand-alone apparatus, which can also be used outdoors.  
         [0018]     The invention also provides a method for examining the sole of a foot, using the following steps: 
        (a) making an electronic image of the sole of a foot of a subject with the aid of the image-recording means;     (b) sending the electronic image to a remote monitor;     (c) examining the sole of the foot by viewing the monitor.        
 
         [0022]     The examining process can further comprise the following: 
        (d) detecting any small wounds that may be present on the sole of the foot;     (e) comparing the condition of the sole of the foot with results of any previous examination of the sole        
 
         [0025]     The subject of the foot sole examination can preferably also views the electronic image himself/herself on a visual display unit that can be connected.  
         [0026]     The present invention also to the use of a foot sole recording device for examining a diabetic foot, said device comprising image-recording means for making an electronic image of the sole, wherein the device comprises sending means for transmitting the electronic image to a remote monitor.  
         [0027]     The invention also includes a monitoring system comprising: 
        1. a communication network;     2. a foot sole recording device configured to create an electronic image of the sole send he electronic image into the communication network;     3. a monitoring device configured to receive the electronic image from the communication network, and to display the image.        
 
         [0031]     The monitoring system enables remote examination of diabetic feet. For example, a doctor in a remote hospital location is able to examine a sole without requiring that the subject visit the hospital.  
         [0032]     Further advantages and features of the present invention will become clear on inspecting the description of a preferred embodiment, with reference to the appended drawings 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0033]      FIG. 1  shows a side view of a device according to the invention;  
         [0034]      FIG. 2  is a top view of a device according to the invention.  
         [0035]      FIG. 3  is a side view of a preferred embodiment of the invention;  
         [0036]      FIG. 4  is a diagram of a monitoring system according to an aspect of the invention. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0037]      FIG. 1  shows a side view of an embodiment of the device according to the invention. The device  1  comprises a transparent supporting surface  11 , made of, for example, glass. A foot  12  can be placed on the supporting surface  11 . The device  1  comprises a video camera  13 , which is directed at the transparent supporting surface  11 . The transparent supporting surface  11  is preferably supported on a box-shaped construction  15 . The device  1  comprises sending means  10 , for example a modem, for transmitting image information to a remote monitor. In a preferred embodiment, the sending means  10  is/are connected to an output port of the video camera  13 . The sending means can comprise a modem, which can be connected to a computer network, such as the Internet, so that the recorded image can be sent to a remote target, for example, a doctor. The latter can then examine the image and, if necessary, invite the user of the device  1  for further examination. An address of the examining doctor to which the data is to be sent may be input in advance, possibly by a supplier. Since privacy and confidentiality of data about any subject&#39;s condition is generally desired, the data preferably are sent in encoded form. The device can also comprise a switching means  20 , such as a switch, which is connected to the camera  13 , and is designed so that when pressure is exerted upon the supporting surface  11 , the camera  13  is engaged or activated, optionally after a delay.  
         [0038]     In one embodiment the device  1  comprises a (wireless) connection  14  of the video camera  13  to a display means such as, for example, a television. The device  1  preferably also comprises a regulating device  16 , such as a remote control, for remote control of the video camera  13 . The device  1  comprises light means  17  for illuminating the sole.  
         [0039]     For user of the device  1  to see the images, the device  1  must be connected to, for example, a television unit. If the connection  14  is a cable, the user must see to it that the cable is connected to an input port of the television. In the case of wireless communication, the wireless connection  14  only need be activated. The television monitor and the video camera  13  then must be switched on and the correct channel selected on the television; this is usually the video channel.  
         [0040]     The user then places one or both feet on the supporting surface  11 . The supporting surface  11  preferably forms an angle with the horizontal plane, so that it is convenient for a subject sitting in a chair to place his feet on the device  1  without exerting too much pressure on the supporting surface  11 . When the feet have been placed, the soles become visible on the TV screen. The user can now increase or reduce the size of the image, if desired, using the regulating device  16 . In another embodiment the sole can be displayed on the visual display unit of a computer. If the correct software and control programs have been loaded, the user can examine the images and store them on, for example, a hard drive of the computer. The video camera  13  can be a digital video camera, an electronic photographic camera or a digital photographic camera. The image-recording means can be a flatbed scanner, preferably connected to a computer.  
         [0041]     In a preferred embodiment, the device  1  comprises a toe-spreading device  21 , which consists of a preferably transparent mat  23  on which elevations or protrusions  22  are provided. The way in which the toe-spreading device  21  operates can be seen more clearly in  FIG. 2 . The toe-spreading device  21  can be placed on the transparent supporting surface  11 , as is shown in  FIG. 1 . The toe-spreading device preferably comprises several elevations or protrusions  22 , which are, for example, in the shape of a cylinder. The toes of the user are placed vertically on the device, so that when they contact the elevations or protrusions  22 , the toes are moved apart, producing larger inter-toe intervals. In this example the toe-spreading device comprises 4 elevations per foot, but fewer elevations are also contemplated.  
         [0042]     The device can also comprise positioning means  24  for positioning the foot  12 . A user can consequently position one or both feet  12  to provide a good view of the soles. The positioning means  24  can consist of two curved lines placed on the supporting surface  11  or on the mat  23 . Alternatively, the positioning means  24  could also comprise two optionally curved, upright arches, against which the heels are placed.  
         [0043]      FIG. 3  shows a side view of a preferred embodiment of the device, wherein the device  1  comprises a triangular shaped box comprising a heel support  31  which is configured to activate a pressure sensor  32  when pressure is exerted on the heel support  31 . The heel support  31  is configured to receive a heel of a foot, in such a way that the sole of the foot remains fully visible to the lens or other recording means of camera  33  present in the triangular shaped box  30 . The pressure sensor  32  is configured to activate the camera  33 . The device  1  may have one or two heel supports  31 . If the device  1  has only one heel support, a user will have to switch feet in order to record images of both foot soles. Using a device  1  as shown in  FIG. 3 , a person can examine the sole of his foot while sitting a chair. This is very convenient, particularly for diabetic patients or others with limited mobility.  
         [0044]      FIG. 4  is a diagram of a monitoring system  40  according to the invention. The monitoring system  40  comprises a communication network  41 , such as the Internet, and a food sole recording device  42  configured to create an electronic image of the sole. The device  42  is configured to send an electronic image to or into the communication network  41 . The device may comprise, for example, a mobile communication device (not shown in this drawing), which is configured to connect to the communication network  41  via a telephone line. The monitoring system  40  preferably further comprises a monitoring device  45  configured to receive the electronic image from the communication network  41 , and to display the electronic image.  
         [0045]     Preferably, the monitoring device  45  comprises memory (not shown in this drawing) for storing electronic images. Furthermore, the monitoring device  45  may be configured to display (e.g., on a screen) the electronic images together with previously received and recorded images. In this way a doctor, or other health professional, can compare images and determine whether a foot, such as a diabetic foot, is deteriorating over time. If the health professional discerns the need for direct action, he can call the subject into the hospital or other medical facility. If no change, or only minor changes are noted, the health professional may choose not to bring the subject in for a face-to-face meeting. Rather, the health professional can elect to phone the subject to discuss or check his status.  
         [0046]     In one embodiment, the food sole recording device  42  is configured to send identification information identifying the recording device  42  and/or a user (not shown in this drawing) to the monitoring device  45 . The monitoring device  45  may be configured to file the electronic images of one subject, in order to organize data by individual subjects from whom the images are obtained. This can be accomplished by reading the identification information which is sent by the recording device  42  together with the electronic images and storing them in a suitably designed database. Such databases are well-known in the art.  
         [0047]     The camera can, for example, be set to record several images after activation and to send those that meet a desired criterion (such as sharpness of image). Light means that emits light of a certain wavelength may be used. For example, infrared light can be used, to create a temperature profile of the sole. This temperature profile maybe sent together with a true copy of the image of the sole, so that a health professional or other recipient of the data has additional useful information. Monochromatic light may also be used. Drying of the sole can be detected most easily with the aid of ultraviolet light. Other wavelengths are also useful, so that, for example, underlying structures in the sole can be made visible. Alarm means may also be included to alert the subject, for example, to the fact that a photograph should be made and sent. The device can also comprise another alarm means to remind the subject at regular, predetermined intervals to examine his foot or feet. This assures regular transmission of an image to an examining point, such as to a health professional. In addition, the device may be equipped to transmit identification data, to clearly identify to a receiving health professional, computer or database the identity of the subject whose image has arrived or will arrive.  
         [0048]     Any references cited above are all incorporated by reference herein, whether specifically incorporated or not.  
         [0049]     Having now fully described this invention, it will be appreciated by those skilled in the art that the same can be performed within a wide range of equivalent parameters and conditions without departing from the spirit and scope of the invention and without undue experimentation.