Hypovolemia/hypervolemia and intravenous infiltration detection using peripheral intravenous waveform analysis (piva) and applications of same

Abstract

Peripheral intravenous (IV) waveform analysis (PIVA) systems and methods for determining an intravascular volume status of a living subject and monitoring an IV line functionality of a peripheral IV device are provided. The PIVA system includes a peripheral IV device and a processing device. The peripheral IV device includes a peripheral IV catheter inserted into a vein of the living subject, and a fluid controlling device to control fluid flow from a fluid source to the peripheral IV catheter. The processing device receives peripheral venous signals from the peripheral IV device, performs a spectral analysis on the peripheral venous signals to obtain a peripheral venous pressure frequency spectrum; and performs a statistical analysis on amplitudes of peaks of the peripheral venous pressure frequency spectrum to determine an intravascular volume status of the living subject and/or an IV line functionality of the peripheral IV catheter in real time.

What is claimed is: 
     
         1 . An peripheral intravenous (IV) waveform analysis (PIVA) system, comprising:
 a peripheral IV device configured to acquire, from a vein of a living subject, peripheral venous signals, wherein the peripheral IV device comprises:
 a peripheral IV catheter, configured to be inserted into the vein of the living subject; and 
 a fluid controlling device in fluid communication with the peripheral IV catheter, configured to control fluid flow from a fluid source to the peripheral IV catheter; and 
   a processing device communicatively connected to the peripheral IV device, configured to:
 receive the peripheral venous signals from the peripheral IV device; 
 perform a spectral analysis on the peripheral venous signals to obtain a peripheral venous pressure frequency spectrum; and 
 perform a statistical analysis on amplitudes of peaks of the peripheral venous pressure frequency spectrum to determine an intravascular volume status of the living subject in real time, wherein the intravascular volume status of the living subject indicates hypovolemia when amplitude decreases greater than a first threshold are detected from the peaks of the peripheral venous pressure frequency spectrum; 
   wherein the processing device is capable of performing the statistical analysis on the amplitudes of the peaks of the peripheral venous pressure frequency spectrum to determine an IV line functionality of the peripheral IV catheter in real time, wherein the IV line functionality of the peripheral IV catheter indicates IV infiltration when amplitude decreases greater than a second threshold are detected from the peaks of the peripheral venous pressure frequency spectrum;   wherein when the IV line functionality of the peripheral IV catheter indicates IV infiltration, the processing device is capable of controlling the fluid controlling device to stop the fluid flow from the fluid source to the peripheral IV catheter.   
     
     
         2 . The PIVA system of  claim 1 , wherein the intravascular volume status of the living subject indicates hypervolemia when amplitude increases greater than a third threshold are detected from the peaks of the peripheral venous pressure frequency spectrum. 
     
     
         3 . The PIVA system of  claim 2 , being applied to the living subject during ultrafiltration/dialysis or diuresis of the living subject, wherein the processing device is further configured to:
 generate an alert message when the intravascular volume status of the living subject indicates hypovolemia.   
     
     
         4 . The PIVA system of  claim 1 , being applied to the living subject during resuscitation of the living subject, wherein:
 the intravascular volume status of the living subject indicates a return of euvolemia from a hypovolemic state when the living subject is determined to be in the hypovolemic state at an earlier time period, and amplitude increases greater than a fourth threshold are detected from the peaks of the peripheral venous pressure frequency spectrum; and   the intravascular volume status of the living subject indicates over-resuscitation when the living subject is determined to be in an euvolemic state at the earlier time period, and amplitude increases greater than a fifth threshold are detected from the peaks of the peripheral venous pressure frequency spectrum.   
     
     
         5 . The PIVA system of  claim 4 , wherein the processing device is further configured to:
 detect efficacy of treatment and the return to euvolemia in the living subject based on the intravascular volume status of the living subject.   
     
     
         6 . The PIVA system of  claim 1 , wherein the processing device is a computing device. 
     
     
         7 . The PIVA system of  claim 1 , wherein the processing device is communicatively connected to the peripheral IV device through a wireless connection. 
     
     
         8 . The PIVA system of  claim 1 , wherein the peripheral IV device further comprises:
 a monitoring device connected to the peripheral IV catheter, configured to capture and record the peripheral venous signals from the peripheral IV catheter at a sampling rate.   
     
     
         9 . The PIVA system of  claim 8 , wherein the monitoring device comprises a pressure transducer directly connected to the peripheral IV catheter, wherein the peripheral venous signals are captured and recorded by the pressure transducer. 
     
     
         10 . The PIVA system of  claim 8 , wherein the sampling rate is about 1 kHz. 
     
     
         11 . The PIVA system of  claim 1 , wherein the peripheral IV catheter is a peripherally-inserted central catheter (PICC). 
     
     
         12 . The PIVA system of  claim 1 , wherein the spectral analysis is a spectral fast Fourier transform (FFT) analysis. 
     
     
         13 . The PIVA system of  claim 12 , wherein the statistical analysis comprises:
 obtaining a plurality of baseline peaks {B N_1 } on a baseline peripheral venous pressure frequency spectrum, wherein N is a positive integer, and the plurality of baseline peaks {B N-1 } respectively corresponds to a plurality of frequencies {F 0 , F 1 , . . . , F N }, such that B N-1  is a function of F N-1  satisfying B N-1 =B N-1  (F N-1 ), wherein F N  is greater than F N-1 ;   obtaining a plurality of peaks {P N-1 } on the peripheral venous pressure frequency spectrum, wherein the plurality of peaks {P N-1 } correspond to the plurality of frequencies {F 0 , F 1 , . . . , F N }, such that P N-1  is a function of F N-1  satisfying P N-1 =P N-1  (F N-1 ); and   determining the intravascular volume status of the living subject and the IV line functionality in real time by comparing the amplitudes of the peaks {P N-1 } to that of the baseline peaks {B N_1 } respectively.   
     
     
         14 . The PIVA system of  claim 13 , wherein:
 the plurality of peaks {P N-1 } comprises a first peak P 0  corresponding to a first frequency F 0  and a second peak P 1  corresponding to a second frequency F 1 , wherein the second frequency F 1  is greater than the first frequency F 0 ;   the first peak P 0  corresponding to the first frequency F 0  is associated with a respiratory rate of the living subject; and   the second peak P 1  corresponding to the second frequency F 1  is associated with a heart rate of the living subject.   
     
     
         15 . The PIVA system of  claim 13 , wherein the baseline peripheral venous pressure frequency spectrum is obtained by:
 acquiring, by the peripheral IV device, the peripheral venous signals from the vein of the living subject at an earlier time period; and   processing the peripheral venous signals acquired at the earlier time period by the spectral FFT analysis to obtain the baseline peripheral venous pressure frequency spectrum.   
     
     
         16 . The PIVA system of  claim 1 , further comprising:
 a pump connected to the living subject to perform liquid exchange to the living subject; and   a pump controlling mechanism communicatively connected to the processing device, configured to control the pump by intermittently pausing the pump or subtract the pump signal when the peripheral IV device acquires the peripheral venous signals, and restarting the pump when the peripheral IV device does not acquire the peripheral venous signals;   wherein the processing device is further configured to send a signal to the pump controlling mechanism to notify the pump controlling mechanism to control the pump.   
     
     
         17 . The PIVA system of  claim 16 , wherein the pump is a dialysis pump, a cardiopulmonary bypass pump, an extracorporeal membrane oxygenation (ECMO), or an infusion pump. 
     
     
         18 . A method for determining an intravascular volume status of a living subject and monitoring an intravenous (IV) line functionality of a peripheral IV device, wherein the peripheral IV device comprises:
 a peripheral IV catheter, configured to be inserted into a vein of the living subject; and   a fluid controlling device in fluid communication with the peripheral IV catheter, configured to control fluid flow from a fluid source to the peripheral IV catheter,   
       the method comprising:
 acquiring, from the peripheral IV catheter, peripheral venous signals; 
 performing, by a processing device communicatively connected to the peripheral IV device, a spectral analysis on the acquired peripheral venous signals to obtain a peripheral venous pressure frequency spectrum; 
 performing, by the processing device, a statistical analysis on amplitudes of peaks of the peripheral venous pressure frequency spectrum to determine the intravascular volume status of the living subject and the IV line functionality of the peripheral IV device in real time; and 
 when the IV line functionality of the peripheral IV device is determined to indicate IV infiltration, controlling, by the processing device, the fluid controlling device to stop the fluid flow from the fluid source to the peripheral IV catheter, 
 wherein the intravascular volume status of the living subject indicates hypovolemia when amplitude decreases greater than a first threshold are detected from the peaks of the peripheral venous pressure frequency spectrum. 
 
     
     
         19 . The method of  claim 18 , wherein the intravascular volume status of the living subject indicates hypervolemia when amplitude increases greater than a third threshold are detected from the peaks of the peripheral venous pressure frequency spectrum. 
     
     
         20 . The method of  claim 18 , wherein the processing device is a computing device. 
     
     
         21 . The method of  claim 18 , wherein the processing device is communicatively connected to the peripheral IV device through a wireless connection. 
     
     
         22 . The method of  claim 18 , wherein the peripheral IV catheter is a peripherally-inserted central catheter (PICC). 
     
     
         23 . The method of  claim 18 , wherein the spectral analysis is a spectral fast Fourier transform (FFT) analysis. 
     
     
         24 . The method of  claim 23 , wherein the statistical analysis comprises:
 obtaining a plurality of baseline peaks {B N-1 } on a baseline peripheral venous pressure frequency spectrum, wherein N is a positive integer, and the plurality of baseline peaks {B N-1 } respectively corresponds to a plurality of frequencies {F 0 , F 1 , . . . , F N }, such that B N-1  is a function of F N-1  satisfying B N-1 =B N-1  (F N-1 ), wherein F N  is greater than F N-1 ;   obtaining a plurality of peaks {P N-1 } on the peripheral venous pressure frequency spectrum, wherein the plurality of peaks {P N-1 } correspond to the plurality of frequencies {F 0 , F 1 , . . . , F N }, such that P N-1  is a function of F N-1  satisfying P N-1 =P N-1  (F N-1 ); and   determining the intravascular volume status of the living subject and the IV line functionality in real time by comparing the amplitudes of the peaks {P N-1 } to that of the baseline peaks {B N-1 } respectively.   
     
     
         25 . The method of  claim 24 , wherein:
 the plurality of peaks {P N-1 } comprises a first peak P 0  corresponding to a first frequency F 0  and a second peak P 1  corresponding to a second frequency F 1 , wherein the second frequency F 1  is greater than the first frequency F 0 ;   the first peak P 0  corresponding to the first frequency F 0  is associated with a respiratory rate of the living subject; and   the second peak P 1  corresponding to the second frequency F 1  is associated with a heart rate of the living subject.   
     
     
         26 . The method of  claim 24 , wherein the baseline peripheral venous pressure frequency spectrum is obtained by:
 acquiring the peripheral venous signals from the peripheral IV catheter at an earlier time period; and   processing the peripheral venous signals acquired at the earlier time period by the spectral FFT analysis to obtain the baseline peripheral venous pressure frequency spectrum.   
     
     
         27 . A method for determining hypovolemia, hypervolemia and vascular tone of a living subject based on an intravascular volume status of the living subject using the PIVA system of  claim 1 . 
     
     
         28 . An peripheral intravenous (IV) waveform analysis (PIVA) system, comprising:
 a peripheral IV device configured to acquire, from a vein of a living subject, peripheral venous signals, wherein the peripheral IV device comprises:
 a peripheral IV catheter, configured to be inserted into the vein of the living subject; and 
 a fluid controlling device in fluid communication with the peripheral IV catheter, configured to control fluid flow from a fluid source to the peripheral IV catheter; and 
   a processing device communicatively coupled to the peripheral IV device, configured to:
 receive the peripheral venous signals from the peripheral IV device; 
 perform a spectral analysis on the peripheral venous signals to obtain a peripheral venous pressure frequency spectrum; and 
 perform a statistical analysis on amplitudes of peaks of the peripheral venous pressure frequency spectrum to determine an intravascular volume status of the living subject in real time, wherein the intravascular volume status of the living subject indicates hypovolemia when amplitude decreases greater than a first threshold are detected from the peaks of the peripheral venous pressure frequency spectrum; 
   wherein the processing device is capable of performing the statistical analysis on the amplitudes of the peaks of the peripheral venous pressure frequency spectrum to determine an IV line functionality of the peripheral IV catheter in real time, and wherein the IV line functionality of the peripheral IV catheter indicates IV infiltration when amplitude decreases greater than a second threshold are detected from the peaks of the peripheral venous pressure frequency spectrum.   
     
     
         29 . The PIVA system of  claim 28 , wherein when the IV line functionality of the peripheral IV catheter indicates IV infiltration, the processing device is capable of controlling the fluid controlling device to stop the fluid flow from the fluid source to the peripheral IV catheter. 
     
     
         30 . The PIVA system of  claim 28 , wherein the first threshold and the second threshold of the amplitudes of peaks of the peripheral venous frequency spectrum are different. 
     
     
         31 . The PIVA system of  claim 30 , wherein the value of the first threshold is greater than the value of the second threshold of the amplitudes of peaks of the peripheral venous frequency spectrum. 
     
     
         32 . An peripheral intravenous (IV) waveform analysis (PIVA) system, comprising:
 a peripheral IV device configured to acquire, from a vein of a living subject, peripheral venous signals, wherein the peripheral IV device comprises:
 a peripheral IV catheter, configured to be inserted into the vein of the living subject; and 
 a fluid controlling device in fluid communication with the peripheral IV catheter, configured to control fluid flow from a fluid source to the peripheral IV catheter; and 
   a processing device communicatively coupled to the peripheral IV device, configured to:
 receive the peripheral venous signals from the peripheral IV device; 
 perform a spectral analysis on the peripheral venous signals to obtain a peripheral venous pressure frequency spectrum; and 
 perform at least one of the following statistical analysis on amplitudes of peaks of the peripheral venous pressure frequency spectrum:
 an analysis to determine whether an intravascular volume status of the living subject in real time indicates hypovolemia when amplitude decreases greater than a first threshold are detected from the peaks of the peripheral venous pressure frequency spectrum; and 
 an analysis to determine whether an IV line functionality of the peripheral IV catheter in real time indicates IV infiltration when amplitude decreases greater than a second threshold are detected from the peaks of the peripheral venous pressure frequency spectrum. 
 
   
     
     
         33 . The PIVA system of  claim 32 , wherein when the IV line functionality of the peripheral IV catheter indicates IV infiltration, the processing device is capable of controlling the fluid controlling device to stop the fluid flow from the fluid source to the peripheral IV catheter. 
     
     
         34 . The PIVA system of  claim 32 , wherein the first threshold and the second threshold of the amplitudes of peaks of the peripheral venous frequency spectrum are different. 
     
     
         35 . The PIVA system of  claim 34 , wherein the value of the first threshold is greater than the value of the second threshold of the amplitudes of peaks of the peripheral venous frequency spectrum.