Systems, devices and methods for sensing physiologic data and draining and analyzing bodily fluids

Abstract

Systems, devices and methods for sensing physiologic data and draining and analyzing bodily fluids are described which are capable of sensing physiologic data based on sensors incorporated into a catheter adapted to reside in any of a urinary tract, gastrointestinal tract, rectal location, pre-peritoneal, pleural space or other body cavity. The devices aid emptying of the bladder, measure urine output and various urine parameters such as oxygen tension, urine conductance and urine specific gravity, monitor renal function, analyze urine parameters, including urine content, including the presence of infection, and track and/or control fluid administration.

1 .- 2 . (canceled) 
     
     
         3 . A system for controlling infusion into a patient body, comprising:
 an elongate catheter having one or more openings at or near a distal end of the catheter and further defining a drainage lumen in fluid communication with the one or more openings;   a controller in communication with the drainage lumen and which is programmed to periodically adjust a pressure level within the drainage lumen to clear obstructions;   a urine reservoir in fluid communication with the drainage lumen and which is in communication with the controller which is further programmed to monitor a urine output received in the urine reservoir from the patient body;   a fluid reservoir in fluid communication with an infusion lumen and which is in communication with the controller; and   wherein the controller is further programmed to adjust a flow of fluid from the fluid reservoir into the patient body based upon the monitored urine output.   
     
     
         4 . The system of  claim 3  further comprising a venting mechanism coupled to the drainage lumen, the venting mechanism configured to pass air therethrough when a negative pressure is applied to the venting mechanism by the controller to clear any obstructions. 
     
     
         5 . The system of  claim 4  wherein the venting mechanism comprises a one-way valve which is configured to prevent fluid from exiting the drainage lumen. 
     
     
         6 . The system of  claim 4  wherein the venting mechanism comprises a vent having a hydrophobic membrane which is configured to transmit gas but not liquid therethrough. 
     
     
         7 . The system of  claim 6  wherein the hydrophobic membrane comprises a PTFE or ePTFE membrane. 
     
     
         8 . The system of  claim 3  wherein the controller is further programmed to apply a negative pressure to the drainage lumen at predefined intervals of time. 
     
     
         9 . The system of  claim 3  wherein the fluid from the fluid reservoir comprises a hydrating fluid. 
     
     
         10 . The system of  claim 3  wherein the fluid from the fluid reservoir comprises a medication. 
     
     
         11 . The system of  claim 3  wherein the controller is programmed to automatically adjust the flow of fluid based on the monitored urine output. 
     
     
         12 . The system of  claim 3  wherein the controller is programmed to adjust the flow of fluid based on an open loop feedback of the monitored urine output. 
     
     
         13 . The system of  claim 3  wherein the controller is programmed to adjust the flow of fluid based on a semi-closed loop feedback of the monitored urine output. 
     
     
         14 . The system of  claim 3  wherein the controller is further configured to store patient data. 
     
     
         15 . The system of  claim 14  wherein the patient data is stored in a memory component. 
     
     
         16 . The system of  claim 14  wherein the system is configured to transfer the patient data to a remote database. 
     
     
         17 . The system of  claim 3  wherein the urine reservoir comprises a cassette component having a rigid housing. 
     
     
         18 . The system of  claim 17  wherein the controller is configured to receive and interface with the cassette component. 
     
     
         19 . The system of  claim 3  wherein the controller is further programmed to analyze patient data obtained from the patient including the urine output and determine one or more trends or relationships between one or more parameters of the patient data as a predictor of infection or patient behavior. 
     
     
         20 . The system of  claim 3  wherein the controller is further programmed to sense one or more physiological parameters of the patient comprising a respiratory rate or a heart rate. 
     
     
         21 . The system of  claim 3  further comprising a light transmitter and receiver in proximity to the reservoir, wherein the reservoir defines an optically clear section. 
     
     
         22 . The system of  claim 21  wherein the receiver is in communication with the controller which is further programmed to detect one or more wavelengths transmitted through the urine reservoir and through a volume of the urine contained within. 
     
     
         23 . The system of  claim 22  wherein the controller is further programmed to analyze the one or more wavelengths for a presence of bacteria, red blood cells, plasma, or white blood cells as indicative of an infection. 
     
     
         24 . A method of controlling infusion into a patient body, comprising:
 receiving urine into one or more openings defined at or near a distal end of an elongate catheter and through a drainage lumen defined through the elongate catheter;   collecting the urine within a urine reservoir which is in fluid communication with the drainage lumen;   monitoring a urine output received within the urine reservoir via the controller;   periodically adjusting a pressure level within the drainage lumen via a controller to clear obstructions within the drainage lumen;   infusing a flow of fluid from a fluid reservoir and into the patient body through an infusion lumen; and   adjusting the flow of fluid from the fluid reservoir based upon the monitored urine output.   
     
     
         25 . The method of  claim 24  wherein periodically adjusting a pressure level further comprises venting air through a venting mechanism which is in communication with the drainage lumen to clear any obstructions. 
     
     
         26 . The method of  claim 24  wherein periodically adjusting a pressure level further comprises applying a negative pressure to the drainage lumen at predefined intervals of time. 
     
     
         27 . The method of  claim 24  wherein infusing a flow of fluid from a fluid reservoir comprises infusing a hydrating fluid. 
     
     
         28 . The method of  claim 24  wherein infusing a flow of fluid from a fluid reservoir comprises infusing a medication. 
     
     
         29 . The method of  claim 24  wherein adjusting the flow of fluid comprises automatically adjusting the flow based the monitored urine output. 
     
     
         30 . The method of  claim 24  wherein adjusting the flow of fluid comprises automatically adjusting the flow based on an open loop feedback of the monitored urine output. 
     
     
         31 . The method of  claim 24  wherein adjusting the flow of fluid comprises automatically adjusting the flow based on a semi-closed loop feedback of the monitored urine output. 
     
     
         32 . The method of  claim 24  further comprising storing patient data via the controller. 
     
     
         33 . The method of  claim 32  further comprising transferring the patient data to a remote database. 
     
     
         34 . The method of  claim 24  wherein monitoring a urine output comprises analyzing patient data obtained from the patient including the urine output and determining one or more trends or relationships between one or more parameters of the patient data as a predictor of infection or patient behavior. 
     
     
         35 . The method of  claim 24  wherein monitoring a urine output comprises transmitting a light through an optically clear section of the urine reservoir and receiving the transmitted light in proximity to the urine reservoir. 
     
     
         36 . The method of  claim 35  further comprising detecting one or more wavelengths transmitted through the urine reservoir and through a volume of the urine contained within. 
     
     
         37 . The method of  claim 36  further comprising analyzing the one or more wavelengths for a presence of bacteria, red blood cells, plasma, or white blood cells as indicative of an infection. 
     
     
         38 . The method of  claim 24  further comprising sensing one or more physiological parameters of the patient comprising a respiratory rate or a heart rate.