Body fluid management systems for patient care

Abstract

Provided are body fluid management systems for patient care that include, in operable combination, a control system assembly comprising a fluid flow detection and control subassembly, a user data interface, a patient interface assembly comprising a wearable pressure sensor subassembly having a pressure sensor in the path of said body fluid for attaching directly to a patient proximate to an anatomical marker and an orientation sensor to monitor and/or control the pressure and/or flowrate of a body fluid such as cerebrospinal fluid, blood, or urine.

What is claimed is: 
     
         1 . A body fluid management system, comprising:
 a control system assembly for real-time monitoring of a pressure of a body fluid, and   a patient interface assembly,   wherein said patient interface assembly comprises a tube and a wearable pressure sensor subassembly in-line with said tube,   wherein said tube is configured at one end for connection to a patient-implanted catheter in direct fluid communication with said body fluid and configured at an opposite end for connection to an infusion source containing an infusion fluid,   wherein said wearable pressure sensor subassembly is configured for attaching proximate to a patient anatomical marker,   wherein said wearable pressure sensor subassembly comprises at least one pressure sensor in direct fluid communication with said body fluid,   wherein said control system assembly is configured for monitoring changes in the pressure of said body fluid based on inputs from the patient interface assembly,   wherein said control system assembly is configured to display data, to make adjustments to a flowrate of said infusion fluid, or to assert an alarm based on user-selected operating modes and user-defined settings.   
     
     
         2 . The body fluid management system of  claim 1  wherein said wearable pressure sensor subassembly further comprises an orientation sensor configured to detect an orientation of a body cavity containing said body fluid and a movement of said body cavity,
 wherein said control system assembly is configured for monitoring changes in patient movement or patient orientation. 
 
     
     
         3 . The body fluid management system of  claim 2  wherein said at least one pressure sensor comprises a first pressure sensor and a second pressure sensor,
 wherein said first pressure sensor, said second pressure sensor, and said orientation sensor are configured on a rigid member, 
 wherein said second pressure sensor is located at a fixed spacing distance from said first pressure sensor, 
 wherein said control system assembly is configured to calculate an anticipated differential pressure between said first pressure sensor and said second pressure sensor based on said fixed spacing distance and orientation of said rigid member as detected by said orientation sensor, 
 wherein said control system assembly is configured to calculate an actual differential pressure between said first pressure sensor and said second pressure sensor based on direct measured pressure of said body fluid, and 
 wherein said control system assembly is configured for detecting drift in the first pressure sensor or the second pressure sensor based on a disparity between the anticipated differential pressure between the first pressure sensor and the second pressure sensor and the actual differential pressure between the first pressure sensor and the second pressure sensor. 
 
     
     
         4 . The body fluid management system of  claim 1  wherein said control system assembly comprises at least one fluid flow detection and control subassembly. 
     
     
         5 . The body fluid management system of  claim 4  wherein said at least one fluid flow detection and control subassembly is configured to monitor and control a flowrate of said infusion fluid and wherein said control system assembly is configured to calculate volume over a user-selected time interval. 
     
     
         6 . The body fluid management system of  claim 5  wherein a static pressure of said infusion fluid is greater than an average pressure of said body fluid, thereby producing an infusion pressure gradient, and wherein said fluid flow detection and control subassembly comprises a valve configured to allow or disallow flow of said infusion fluid from said infusion source through said tube and said patient-implanted catheter utilizing said infusion pressure gradient, thereby maintaining patency of said tube and said patient-implanted catheter. 
     
     
         7 . The body fluid management system of  claim 5 , wherein said fluid flow detection and control subassembly comprises a pump configured to pump said infusion fluid from said infusion source through said tube and said patient-implanted catheter, thereby maintaining patency of said tube and said patient-implanted catheter. 
     
     
         8 . The body fluid management system of  claim 1  wherein said control system assembly comprises a graphical user interface configured to display a pressure waveform. 
     
     
         9 . The body fluid management system of  claim 1  wherein said body fluid is blood and said patient anatomical marker is the fourth intercostal space at the midaxillary line. 
     
     
         10 . The body fluid management system of  claim 1  wherein said body fluid is venous blood and wherein said control system assembly is configured for real-time monitoring of central venous pressure. 
     
     
         11 . The body fluid management system of  claim 1  wherein said body fluid is arterial blood and wherein said control system assembly is configured for real-time monitoring of mean arterial pressure. 
     
     
         12 . A body fluid management system, comprising a control system assembly and a patient interface assembly,
 wherein said control system assembly is configured to monitor real-time pressure of a body fluid and control drainage of said body fluid according to user selected parameters,   wherein said patient interface assembly comprises a bidirectional fluid line and a body fluid drainage line,   wherein said bidirectional fluid line is configured for connecting at its proximal end to a catheter inserted into a body compartment containing said body fluid, and for connecting at its distal end to an infusion source containing an infusion fluid,   wherein said body fluid drainage line is connected at its proximal end to said bidirectional fluid line, and configured for connecting at its distal end to a drainage reservoir,   wherein at least one pressure sensor is disposed in said bidirectional fluid line, configured to be in fluid communication with said body fluid, and configured to be located proximate to an anatomical marker suitable as an anatomical reference for monitoring a pressure of said body fluid and wherein said control system assembly is configured to communicate pressure values from the at least one pressure sensor.   
     
     
         13 . The system of  claim 12  wherein said control system assembly comprises at least one fluid flow detection and control subassembly configured to monitor and control a flowrate of a fluid and wherein said control system assembly is configured to calculate volume over a user-selected time interval. 
     
     
         14 . The body fluid management system of  claim 13  wherein a static pressure of said infusion fluid is greater than an average pressure of said body fluid, thereby producing an infusion pressure gradient, and wherein said fluid flow detection and control subassembly comprises a valve configured to allow or disallow flow of said infusion fluid from said infusion source through said bidirectional line and said patient-implanted catheter utilizing said infusion pressure gradient. 
     
     
         15 . The body fluid management system of  claim 13 , wherein said fluid flow detection and control subassembly comprises a pump configured to pump said infusion fluid from said infusion source through said bidirectional line and said patient-implanted catheter. 
     
     
         16 . The body fluid management system of  claim 12  wherein said at least one pressure sensor is disposed in a wearable pressure sensor subassembly further comprising at least one orientation sensor and an enclosure configured for attaching proximate to said anatomical marker. 
     
     
         17 . The system of  claim 12  wherein said control system assembly comprises a graphical user interface configured to display at least one pressure waveform. 
     
     
         18 . The system of  claim 13  wherein said at least one fluid flow detection and control subassembly includes a first fluid flow detection and control subassembly and a second fluid flow detection and control subassembly,
 wherein said first fluid flow detection and control subassembly is configured for detecting and controlling flow of said body fluid, 
 wherein said second fluid flow detection and control subassembly is configured for detecting and controlling flow of said infusion fluid. 
 
     
     
         19 . The system of  claim 18  wherein said body fluid drainage volume is a net volume calculated as a difference between detected drainage volume and detected infusion volume. 
     
     
         20 . The system of  claim 12  wherein said control system assembly is configured to assert an alarm according to one or more user defined threshold(s) for body fluid drainage volume, body compartment pressure, pressure waveform, or infusion. 
     
     
         21 . The system of  claim 12  wherein said body cavity is the abdominal cavity, said body fluid is urine, and said body fluid pressure is intra-abdominal pressure. 
     
     
         22 . The system of  claim 12  wherein one of said user selected parameters is target intra-abdominal pressure. 
     
     
         23 . The body fluid management system of  claim 16  wherein said orientation sensor is configured to detect an orientation of a body cavity containing said body fluid and movement of said body cavity,
 and wherein said control system assembly is configured for monitoring changes in patient movement or patient orientation. 
 
     
     
         24 . The body fluid management system of  claim 23  wherein said at least one pressure sensor includes a plurality of first pressure sensors at a fixed spacing distance from one another,
 wherein said plurality of first pressure sensors and said at least one orientation sensor are configured on a rigid member for detecting drift in said plurality of first pressure sensors based on a disparity between an anticipated differential pressure between said plurality of first pressure sensors and an actual differential pressure between said plurality of first pressure sensors. 
 
     
     
         25 . A body fluid management system, comprising a control system assembly and a patient interface assembly,
 wherein said control system assembly is configured to monitor real-time arterial blood pressure, real-time pressure of a body fluid, and real-time perfusion pressure of a body compartment containing said body fluid,   wherein said control system assembly is configured to control drainage of said body fluid according to user selected parameters,   wherein said patient interface assembly comprises a first fluid line and a second fluid line,   wherein said first fluid line is configured for connecting at its proximal end to a first catheter inserted into said body compartment and for connecting at its distal end to a body fluid drainage reservoir,   wherein said second fluid line is configured for connecting at its proximal end to a second catheter fluidly connected to arterial blood and for connecting at its distal end to an infusion source,   wherein at least one first pressure sensor and at least one second pressure sensor are disposed in said first fluid line and configured to be in fluid communication with said body fluid,   wherein at least one third pressure sensor is disposed in said second fluid line and configured to be in fluid communication with said arterial blood,   wherein said at least one first pressure sensor is configured to be located proximate to a first anatomical marker suitable as an anatomical reference for monitoring a pressure of said body fluid,   wherein said at least one second pressure sensor and said at least one third pressure sensor are configured to be co-located proximate to a second anatomical marker suitable as an anatomical reference for monitoring arterial blood pressure,   wherein said control system assembly is configured to display pressure values from the at least one first pressure sensor as the true pressure of body fluid in said body compartment,   wherein said control system assembly is configured to display pressure values from the at least one third pressure sensor as the true pressure of said arterial blood, and   wherein said control system assembly is configured to calculate and display perfusion pressure as a difference between pressure values from the at least one third pressure sensor and pressure values from the at least one second pressure sensor.   
     
     
         26 . The body fluid management system of  claim 25  wherein said at least one first pressure sensor is disposed in a first wearable pressure sensor subassembly further comprising a first orientation sensor and a first enclosure configured for attaching proximate to said first anatomical marker, and
 wherein said at least one second pressure sensor and said at least one third pressure sensor are disposed in a second wearable pressure sensor subassembly further comprising a second orientation sensor and a second enclosure configured for attaching proximate to said second anatomical marker. 
 
     
     
         27 . The system of  claim 25  wherein said control system assembly comprises at least one fluid flow detection and control subassembly. 
     
     
         28 . The system of  claim 27  wherein said at least one fluid flow detection and control subassembly includes a first fluid flow detection and control subassembly and a second fluid flow detection and control subassembly,
 wherein said first fluid flow detection and control subassembly is configured for detecting and controlling flow of said body fluid, 
 wherein said second fluid flow detection and control subassembly is configured for detecting and controlling flow of said infusion fluid. 
 
     
     
         29 . The system of  claim 28  wherein said first fluid flow detection and control subassembly comprises a valve configured to allow or disallow flow of said body fluid from said first catheter to said body fluid drainage reservoir and wherein said second fluid flow detection and control subassembly comprises a pump configured to pump said infusion fluid from said infusion source through said second fluid line and said second catheter. 
     
     
         30 . The system of  claim 25  wherein said control system assembly comprises a graphical user interface configured to display at least one pressure waveform. 
     
     
         31 . The system of  claim 25  wherein said perfusion pressure is cerebral perfusion pressure, said body cavity is the cranial cavity, said body fluid is cerebrospinal fluid, and said body fluid pressure is intracranial pressure. 
     
     
         32 . The system of  claim 25  wherein said perfusion pressure is spinal cord perfusion pressure, said body cavity is the spinal cavity, said body fluid is cerebrospinal fluid, and said body fluid pressure is lumbar pressure. 
     
     
         33 . The system of  claim 25  wherein one of said user selected parameters is target perfusion pressure. 
     
     
         34 . The system of  claim 25  wherein one of said user selected parameters is target intercranial pressure. 
     
     
         35 . The system of  claim 25  wherein one of said user selected parameters is target body fluid drainage volume. 
     
     
         36 . The system of  claim 25  wherein said control system assembly is configured to assert an alarm according to one or more user defined threshold(s) for perfusion pressure, body fluid drainage volume, body fluid pressure, blood pressure, or pressure waveform. 
     
     
         37 . The body fluid management system of  claim 26  wherein said at least one first pressure sensor includes a plurality of first pressure sensors at a fixed spacing distance from one another,
 wherein said plurality of first pressure sensors and said first orientation sensor are configured on a rigid member for detecting drift in said plurality of first pressure sensors based on a disparity between an anticipated differential pressure between said plurality of first pressure sensors and an actual differential pressure between said plurality of first pressure sensors. 
 
     
     
         38 . The body fluid management system of  claim 26  wherein one or both of said second pressure sensor or said third pressure sensor each include a plurality of pressure sensors at a fixed spacing distance from one another,
 wherein said plurality of second or third pressure sensors and said second orientation sensor are configured on a rigid member for detecting drift in said plurality of second or third pressure sensors based on a disparity between an anticipated differential pressure between said plurality of second or third pressure sensors and an actual differential pressure between said plurality of second or third pressure sensors. 
 
     
     
         39 . The system of  claim 28  wherein said first fluid line is configured for bidirectional flow and wherein the distal end of said first fluid line is further configured for connection to a second infusion source. 
     
     
         40 . The system of  claim 39  wherein the at least one fluid flow detection and control subassembly further comprises a third fluid flow detection and control subassembly for detecting and controlling flow from said second infusion source into said first fluid line. 
     
     
         41 . The system of  claim 40  wherein said perfusion pressure is abdominal perfusion pressure, said body cavity is the abdominal cavity, said body fluid is urine, and said body fluid pressure is intra-abdominal pressure.