Abstract:
The present disclosure provides a reusable medical device including a disposable portion and a processor. The disposable portion includes a probe capable of insertion into an opening of the human body for detecting a condition within the body and a memory associated with the probe for storing a value representing an amount of time that the probe has been in use. The processor is electrically connected to the disposable portion and reads and updates the value stored within the memory. The processor further alerts the human or a caretaker of the presence of the condition and/or the expiration of the disposable portion.

Description:
FIELD OF THE INVENTION  
       [0001]     The present invention relates to fecal incontinence assistance devices. More specifically, it relates to a fecal incontinence assistance device with a time of use limitation function.  
       BACKGROUND OF THE INVENTION  
       [0002]     Many personal medical devices are designed to be used for a limited amount of time or a limited number of occurrences of a particular event. In a supervised setting such as a hospital or nursing home, requiring caregivers to follow an established procedure is the normal method to guaranty that those devices are not used beyond their expiration. In that case, the hospital or nursing home must rely on written or computerized care logs to verify that such devices are changed according to their required schedules. In the case of unsupervised care, where patients use the devices themselves, there is no way to ensure that the devices are changed according to their required schedules.  
       SUMMARY OF THE INVENTION  
       [0003]     The present invention provides a reusable medical device comprising a disposable portion and a processor. The disposable portion comprises a probe capable of insertion into an opening of the human body for detecting a condition within the body and a memory associated with the probe for storing a value representing an amount of time that the probe has been in use. The processor is electrically connected to the disposable portion and reads and updates the value stored within the memory. The processor further alerts the human or a caretaker of the presence of the condition. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0004]      FIG. 1  is a perspective view of a disposable catheter according to an embodiment of the of the present invention;  
         [0005]      FIG. 2  is a perspective view of  FIG. 1  having a fecal guard and a filter tip installed upon the probe according to an embodiment of the of the present invention;  
         [0006]      FIG. 3  is a section view of a catheter probe according to an embodiment of the of the present invention;  
         [0007]      FIG. 4  is a perspective view of a memory associated with a disposable catheter according to an embodiment of the of the present invention;  
         [0008]      FIG. 5  is a perspective view of a memory encapsulated in epoxy associated with a disposable catheter according to an embodiment of the of the present invention;  
         [0009]      FIG. 6  is a front perspective view of a processor according to an embodiment of the of the present invention;  
         [0010]      FIG. 7A  is a rear perspective view of a processor without a battery door attached according to an embodiment of the of the present invention;  
         [0011]      FIG. 7B  is a rear perspective view of a processor with a battery door attached according to an embodiment of the of the present invention;  
         [0012]      FIG. 8  is a schematic view of a disposable catheter and processor according to an embodiment of the of the present invention;  
         [0013]      FIGS. 9A, 9B , and  9 C are perspective views of fecal guards according to an embodiment of the of the present invention; and  
         [0014]      FIG. 10  is a perspective view of a filter tip according to an embodiment of the present invention. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0015]     While the invention is susceptible of embodiment in many different forms, there is described in detail preferred embodiments of the invention. It is to be understood that the present disclosure is to be considered only as an example of the principles of the invention. This disclosure is not intended to limit the broad aspect of the invention to the illustrated embodiments. The scope of protection should only be limited by the claims.  
         [0016]     Disclosed is a device for insertion into a human body for blocking an opening of the human body and alerting the person, or an individual caring for the person, when a quantity of effluent has accumulated near the device within the opening. The device is further capable of alerting the person or a caretaker to remove the device to allow the effluent to exit the body. Furthermore, the device has the capability to alert the person when the device should be replaced by the user or caretaker because it has reached a limit beyond which it may no longer be used safely, such that risk of infection or malfunction is minimized.  
         [0017]     In one particular application the device may be used as a fecal incontinence monitor. The fecal incontinence monitor may be inserted in the rectum to block the accidental passage of feces. The device further detects when a quantity of feces has accumulated in the rectum near the monitor to notify the patient or caregiver when fecal matter is present so that it may be expelled at the next opportunity.  
         [0018]     In this regard and referring to  FIGS. 1, 2 , &amp;  3 , the device comprises a silicone catheter tube  10  having a proximal end  12  and a distal end  14 . Near the distal end  14  of the catheter tube  10  is an inflatable balloon  16 . Beyond the inflatable balloon  16  is a probe  18 . The probe  18  is made from a rigid material and comprises a hollow cylinder having two annular exterior barbed ribs  24 ,  26  and two journals  20 , 22 . The silicone tube  10  is placed onto the probe  18  by sliding the tube  10  over barbed rib  26 . The probe  18  further defines two metal electrical contacts  25  molded into the probe  18  such that the contacts  25  protrude through the probe  18  on opposite sides, extend into the interior of the probe  18  and through an opening at an end of the probe  18 . The contacts  25  are attached to electrically conductive wire  34  located within the catheter tube  10 . As a result, if a potential difference is applied to the contacts  25 , when an electrically conductive fluid comes in contact the electrical contacts  25  a complete circuit is accomplished through the fluid, and in this manner comprise a moisture detector.  
         [0019]     The balloon  16  is attached to and is in fluid communication with a hollow air supply tube  28  within the catheter tube  10 . In  FIG. 1 , the balloon  16  is shown in its inflated state. When in its uninflated state, the balloon  16  has an outer diameter generally no greater than that of the catheter tube  10 .  
         [0020]     The hollow air supply tube  28  is further in fluid communication with a check valve  30 . The check valve  30  is biased to a normally closed state wherein air within the air supply tube  28  is trapped within the tube  28 . Furthermore, the balloon  16  is designed to allow air to permeate through the balloon  16  such that an inflated balloon will slowly deflate. In this manner, decubitus ulcers caused by the pressure of the balloon  16  cutting off blood supply to a portion of the rectum are avoided. However, this does require the user to occasionally reinflate the balloon  16 , as described below.  
         [0021]     Referring to  FIGS. 1 and 2 , a small serial memory chip  36  is disposed near the proximal end  12  of the tube  10 . The memory  36  is further attached to electrical wire  38  that leads to a RJ-45 connector. Referring to  FIG. 3 , the memory  36  and the electrical wires  38  are soldered to a printed circuit board and encapsulated in a nonconductive epoxy coating  39  ( FIG. 4 ). The printed circuit board upon which the memory  36  is mounted is preferably no more than generally 0.125 inch by 0.562 inch and more preferably smaller than such dimensions.  
         [0022]     Referring to  FIGS. 6, 7A , and  7 B, the RJ-45 connector  40  is attached to a controller  50 . The controller  50  comprises a small plastic box that may be attached to a user&#39;s belt or pant waistline by means of a clip  52  and further comprises a modular port  54  for insertion of and electrical connection with the RJ-45 connector  40 . The controller  50  further comprises one green light emitting diode (“LED”)  58  and one red LED  56  that notify the user of the status of the electrical contacts  25 , memory  36  and the controller  50 . A switch  59  is provided so that the user may turn the controller on or off. A switch  55  is also provided so that the user may switch between vibrate and beep mode. Referring to  FIG. 8 , the controller  50  further comprises a microprocessor  60  electrically connected to the memory  36  and the electrical contacts  25 . The microprocessor  60  is preferably a CY8C26233-24PVI made by the Cypress Microsystems Corp. of Bothell, Wash. The serial EEPROM is preferably an AT93C46 made by the Atmel Corp. of San Jose, Calif. During operation, the microprocessor  60  occasionally lights the green LED  58  to let the user know that the controller  50  is operating properly. When a low battery condition is present, the microprocessor  60  occasionally lights the red LED  56  to let the user know that the battery (not shown) is low and should be replaced soon.  
         [0023]     When the presence of fecal matter near the probe  18  is indicated by electric current traveling between the metal contacts, the microprocessor  60  causes a vibrator motor  64  to operate if the controller is in vibration mode, or a speaker  62  to sound an audible tone if the controller is in beep mode, to notify the user that he/she should remove the catheter at the next opportunity to expel accumulated feces. To acknowledge and end the alert, the user presses the switch  59 .  
         [0024]     Referring to  FIGS. 2, 9A ,  9 B, and  9 C, in order to control how fecal matter reaches to the contacts, a fecal guard  66  is placed over the probe  18 . The fecal guard  66  is maintained in position over the probe  18  by sliding a fecal guard  66  onto the probe  18  over the rigid, annular rib  24  and placing it over the journals  20 ,  22 . The fecal guards  66  are generally cylindrical in shape with tapered ends  68 . In a central region thereof, the fecal guards  66  comprise cutout portions  70  which may vary in size. By varying the size of the cutout portions  70 , the ability of feces of different consistency to effectively reach the moisture detector can be varied.  
         [0025]     Furthermore, referring to  FIG. 9 , a filter tip  72  is resiliently installed over the barbed rib  24  and held in place by tension and friction. The filter tip also secures the fecal guard  66  to the probe  18 . Filter tip  72  has a tip  74  in the general shape of a paraboloid of revolution and has a hollow, cylindrical body  76 .  
         [0026]     Upon initial communication, the microprocessor  60  functions by polling the memory  36  to determine the present numeric value stored therein. New catheters are provided to the user with the numeric value set to 0. The microprocessor  60  then increments the value of the memory  36  at set time intervals. In this manner, by reading and incrementing the memory  36 , the microprocessor  60  can identify how long the catheter  10  has been in use. The microprocessor  60  can further monitor the memory  36  to determine when the catheter has reached a point beyond which it is no longer safe to use. At such point, the microprocessor  60  can cease to function until a new catheter with a memory  36  value that has not reached an expiration point is attached, can continue to function during a grace period of operation before the microprocessor  60  discontinues operation or can continue indefinitely during the expired period. Preferably, the microprocessor  60  provides a notification to the user or the caretaker when the catheter has expired or will soon expire by lighting one or a combination of multiple LEDs and/or providing audible and/or tactile alerts. Upon expiration, the catheter  10  would be discarded and a new catheter with a new memory  36  set to zero would be implemented.  
         [0027]     In use, the catheter  10  is inserted into the rectum and a balloon  16  on the end of the catheter is inflated through the air supply tube  28  to hold the catheter  10  in place and to seal the rectum. The catheter  10  is inflated by attachment of the check valve  30  to a syringe which forces a measured quantity of air into the balloon  16  to inflate it. When fecal matter is detected, the controller  50  alerts the user by an audible or tactile alert. The user may then stop the alert by pressing the switch  59 , going to a restroom, deflating the balloon  16  by reinstalling the syringe and removing air, and removing the catheter  10  to allow the fecal matter to be expelled.  
         [0028]     Alternatively, rather than providing a memory  36  within the catheter  10  that is incremented, the present invention could implement a memory having a numeric serial number stored thereon. The microprocessor  60  would include a memory that associated a count with the serial number, the count being incremented at predetermined intervals. When the count reached a predetermined threshold, the catheter associated with the serial number would be marked as expired within the memory of the controller and would either cease to function until a new catheter with an unexpired serial number was attached, continue to function during a grace period of operation before the controller discontinues operation with the expired catheter or continue indefinitely during the expired period. Furthermore, the controller  50  would be able to track multiple serial numbers of catheters that have been used with the controller  50 , as well as store the periods of time such catheters were used with the controller  50 .  
         [0029]     In another alternative, the microcontroller could increment the count within the memory  36  not based on time, but instead based upon the occurrence of an event. For example, the memory  36  could be incremented every time an indication of moisture was detected by the moisture sensor  32 . In the event of a catheter that could be used only once, the memory would only need to store a value indicating whether the catheter had detected a single moisture event.  
         [0030]     Furthermore, it is envisioned that a radio frequency transmitter could be provided within the controller  50  to occasionally broadcast a signal to a receiving controller that allows a third party to remotely be notified of a signal from the moisture sensor or be notified of an expired or soon-to-expire condition of the catheter or any other information tracked by the controller.  
         [0031]     Furthermore, it is envisioned that the controller could monitor an air pressure within the air supply tube  28  to determine the inflation status of the balloon  16 . If the controller  50  detected that the balloon  16  was becoming deflated based upon a low air pressure reading, the controller  50  would alert the user or a caretaker so that appropriate action could be taken. It is also envisioned that an electrically operated air pump could also be provided within the controller to reinflate a balloon that, based on the air pressure sensor, was becoming deflated.  
         [0032]     Furthermore, while EEPROM memory is shown and described, any memory capable of holding a value and being incremented could be used instead. Obviously, while the connector is described as a RJ-45 connector, any connector having an appropriate number of conductors would work equally well. Additionally, while it is described that the memory is incremented until an expiration point is reached and new catheters are provided with memory having a value set equal to zero, it is readily apparent to one of ordinary skill in the art that memory could be provided with a value equal to a predetermined value and wherein that value is decremented to zero by the microprocessor.  
         [0033]     While the specific embodiments have been described, numerous modifications come to mind without significantly departing from the spirit of the invention, and the scope of protection should only limited by the scope of the accompanying claims.