Testing of a Medical Fluid Treatment System

Abstract

The present invention relates to medical fluid treatments, such as the treatment of renal failure. More specifically, the present invention relates to the testing of such systems.

1 - 24 . (canceled) 
     
     
         25 . A method for detecting a failure in a system for providing a medical treatment to a patient, the system including a fluid pathway in removable fluidic communication with the patient, a pump, a memory device, and a sensor for measuring a pressure in the fluid pathway, the pump, the memory, and the sensor being operatively connected to an electronic processor, the pump being configured to move a fluid through the fluid pathway and the system being configured to infuse or remove the fluid to or from the patient via the fluid pathway, the method comprising the steps of:
 performing a test to detect an operational failure of the system, the test including,
 actuating the pump, 
 measuring a pressure in the fluidic pathway by the sensor, 
 determining a test result based on the measured pressure, 
 recording data of the test result in the memory device, 
 monitoring a trend of the data of the recorded test result in the memory device, and 
 determining the operational failure of the system based on the data of the recorded test result. 
   
     
     
         26 . The method as in  claim 25 , further comprising the step of:
 initiating the test after the medical treatment is completed.   
     
     
         27 . The method as in  claim 25 , further comprising the step of:
 blocking the fluidic communication between the patient and the fluid pathway.   
     
     
         28 . The method as in  claim 25 , further comprising the step of:
 monitoring the measured pressure by the electronic processor; and   determining by the electronic processor whether the operational failure is present based on the monitored pressure.   
     
     
         29 . The method as in  claim 25 , further comprising the step of:
 stopping the pump when at least one of the monitored pressure reaches a predetermined threshold, a number of pump stroke reaches a predetermined value, and a duration of the test reaches a predetermined time value.   
     
     
         30 . The method as in  claim 25 , wherein the system includes a reusable part and a disposable and non-reusable part, wherein the step of performing the test renders unusable the disposable and non-reusable part. 
     
     
         31 . The method as in  claim 25 , further comprising the step of:
 disconnecting the fluid pathway from the patient before the step of performing the test.   
     
     
         32 . The method as in  claim 25 , further comprising the step of:
 checking that the patient is no longer in fluidic communication with the fluid pathway before the step of performing the test.   
     
     
         33 . The method as in  claim 25 , further comprising the step of:
 preventing the step of performing the test while the patient is fluidly connected to the fluid pathway.   
     
     
         34 . The method as in  claim 25 , wherein the system further includes an occlusion element for the fluid pathway. 
     
     
         35 . The method as in  claim 34 , wherein the occlusion element includes at least one of a valve, connection cap, and clamp, the occlusion element configured to close at least a part of the fluid pathway. 
     
     
         36 . The method as in  claim 34 , wherein the step of blocking the fluid pathway further includes:
 closing the fluid pathway via the occlusion element to define a closed pathway between the pump and the occlusion element, and   wherein the test further includes:   actuating the pump to generate a pressure in the closed fluid pathway.   
     
     
         37 . The method as in  claim 25 , wherein the test further includes the steps of:
 measuring a second pressure in the closed pathway with a second sensor, the second sensor operatively connected to an electronic processor, and   monitoring the second measured pressure by the electronic processor.   
     
     
         38 . The method as in  claim 37 , wherein the test further includes the step of:
 comparing the monitored pressure of the sensor with the monitored second pressure of the second sensor by the electronic processor to detect the operational failure.   
     
     
         39 . The method as in  claim 38 , wherein the test further includes the step of:
 determining the operational failure of the system when a result of the comparing is greater than a predetermined threshold.   
     
     
         40 . The method as in  claim 29 , further comprising the step of:
 determining the operational failure of the system when the pump is stopped before the measured pressure has reached a predetermined threshold.   
     
     
         41 . The method as in  claim 25 , further comprising the step of:
 sending the data to a remote server and alerting the patient of the operational failure of the system, upon detecting the failure by the step of performing the test.   
     
     
         42 . The method as in  claim 25 , further comprising the step of:
 predicting an expected date of maintenance of the system, via at least one of a mathematical model and a table.   
     
     
         43 . The method as in  claim 42 , further comprising the step of:
 sending a report to the remote server, the report including the predicted expected date of maintenance of the system.   
     
     
         44 . The method as in  claim 25 , wherein the operational failure includes a misfunction of the sensor. 
     
     
         45 . The method as in  claim 25 , wherein the operational failure of the system includes a leakage of the fluid pathway caused by a decoupling of the sensor to the fluidic pathway. 
     
     
         46 . The method as in  claim 25 , wherein the operational failure of the system includes an improper interconnection of a cassette for holding the fluid to the fluid pathway. 
     
     
         47 . The method as in  claim 25 , wherein the operational failure of the system includes a wear of the system. 
     
     
         48 . A medical system for providing a medical treatment to a patient, the system including a fluid pathway in removable fluidic communication with the patient, a pump, a memory device, and a sensor for measuring a pressure in the fluid pathway, the pump, the memory, and the sensor operatively connected to an electronic processor, the pump configured to move a fluid through the fluid pathway, the medical system configured to infuse or remove the fluid to or from the patient via the fluid pathway, the electronic processor is configured to actuate the pump,
 receive a pressure in the fluid pathway measured by the sensor,   determine a test result based on the measured pressure,   record data of the test result in the memory device,   monitor a trend of the data of the recorded test result in the memory device, and   determine an operational failure of the system based on the data of the recorded test result.   
     
     
         49 . The system as in  claim 48 , wherein the operational failure includes a misfunction of the sensor. 
     
     
         50 . The system as in  claim 48 , wherein the electronic processor is further configured to:
 initiate the test after the medical treatment is completed.   
     
     
         51 . The system as in  claim 48 , wherein the system further includes an occlusion element for the fluid pathway, and the electronic processor is further configured to block the fluidic communication between the patient and the fluid pathway by the occlusion element. 
     
     
         52 . The system as in  claim 48 , wherein the electronic processor is further configured to:
 monitor the measured pressure, and   determine whether the operational failure is present based on the monitored pressure.   
     
     
         53 . The system as in  claim 48 , wherein the electronic processor is further configured to:
 stop the pump when at least one of the monitored pressure reaches a predetermined threshold, a number of pump stroke reaches a predetermined value, and a duration of the test reaches a predetermined time value.   
     
     
         54 . The system as in  claim 48 , wherein the electronic processor is further configured to:
 check that the patient is no longer in fluidic communication with the fluid pathway before the step of performing the test.   
     
     
         55 . The system as in  claim 51 , wherein the occlusion element includes at least one of a valve, connection cap, and clamp configured to close at least a part of the fluid pathway. 
     
     
         56 . The system as in  claim 51 , wherein the electronic processor is further configured to,
 close the fluid pathway via the occlusion element to define a closed pathway between the pump and the occlusion element, and   actuate the pump to generate a pressure in the closed fluid pathway.   
     
     
         57 . The system as in  claim 48 , wherein the electronic processor is further configured to
 measure a second pressure in the closed pathway with a second sensor, the second sensor operatively connected to an electronic processor, and   monitor the second measured pressure by the electronic processor.   
     
     
         58 . The system as in  claim 57 , wherein the electronic processor is further configured to
 compare the monitored pressure of the sensor with the monitored second pressure of the second sensor by the electronic processor to detect the operational failure.   
     
     
         59 . The system as in  claim 58 , wherein the electronic processor is further configured to
 determine the operational failure of the system when a result of the comparing is greater than a predetermined threshold.   
     
     
         60 . The system as in  claim 51 , wherein the electronic processor is further configured to
 determine the operational failure of the system when the pump is stopped before the measured pressure has reached a predetermined threshold.   
     
     
         61 . The system as in  claim 48 , wherein the electronic processor is further configured to
 send the data to a remote server and alert the patient of the operational failure of the system, upon detecting the failure.   
     
     
         62 . The system as in  claim 48 , wherein the electronic processor is further configured to
 predict an expected date of maintenance of the system, via at least one of a mathematical model and a table.   
     
     
         63 . The system as in  claim 48 , wherein the electronic processor is further configured to
 send a report to the remote server, the report including the predicted expected date of maintenance of the system.   
     
     
         64 . The system as in  claim 48 , wherein the operational failure of the system includes a leakage of the fluid pathway caused by a decoupling of the sensor to the fluidic pathway. 
     
     
         65 . The system as in  claim 48 , wherein the operational failure of the system includes an improper interconnection of a cassette for holding the fluid to the fluid pathway. 
     
     
         66 . The system as in  claim 48 , wherein the operational failure of the system includes a wear of the system.