Intravenous access device detecting intravenous infiltration and in-vein placement

• US 10,531,799 B2
• Filed: 02/03/2016
• Issued: 01/14/2020
• Est. Priority Date: 09/12/2014
• Status: Active Grant

• Current Assignee: Vanderbilt University
• Original Assignee: Vanderbilt University
• Inventors: Eagle, Susan S., Brophy, Colleen, Hocking, Kyle Mitchell, Baudenbacher, Franz, Boyer, Richard
• Primary Examiner(s): Weare, Meredith
• Application Number:
  US15/547,935
• Publication Number:
  US 20180020935A1
• Time in Patent Office: 1,441 Days
• CPC Class Codes: A61B 5/02152 specially adapted for venous pressure
• CPC Class Codes: A61B 5/7235 Details of waveform analysis A61B5/349 takes precedence
• CPC Class Codes: A61B 5/7257 using Fourier transforms
• CPC Class Codes: A61M 2005/1588 having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

Aspects of the invention relates to systems and methods for monitoring an intravenous (IV) line functionality of an IV device. In one embodiment, the system includes an IV catheter to be inserted into the vein of the living subject, at least one pressure sensor in fluid communication with the IV catheter to acquire peripheral venous signals; and a processing device. The processing device receives the peripheral venous signals from the pressure sensor, performs a spectral analysis on the peripheral venous signals to obtain a peripheral venous pressure frequency spectrum, and then performs a statistical analysis on amplitudes of peaks of the peripheral venous pressure frequency spectrum to determine an IV line functionality of the IV catheter in real time. When the IV line functionality indicates IV infiltration, the processing device may control the fluid controlling device to stop the fluid flow from the fluid source to the IV catheter.

Claims

1. An intravenous (IV) system, comprising:

an IV catheter, configured to be inserted into a vein of a living subject;

a fluid controlling device in fluid communication with the IV catheter, configured to control fluid flow from a fluid source to the IV catheter;

at least one pressure sensor in fluid communication with the IV catheter, configured to acquire, from the vein of the living subject, peripheral venous signals; and

a processing device communicatively connected to the at least one pressure sensor, configured to;

receive the peripheral venous signals from the at least one pressure sensor;

perform a spectral analysis on the peripheral venous signals to obtain a peripheral venous pressure frequency spectrum;

perform a statistical analysis on amplitudes of peaks of the peripheral venous pressure frequency spectrum to determine an IV line functionality of the IV catheter in real time, wherein the IV line functionality of the IV catheter indicates IV infiltration when amplitude decreases greater than a first threshold are detected from the peaks of the peripheral venous pressure frequency spectrum; and

when the IV line functionality of the IV catheter indicates IV infiltration, control the fluid controlling device to stop the fluid flow from the fluid source to the IV catheter.

2. The system of claim 1, wherein the IV infiltration indicates occlusion or malposition of the IV catheter.

3. The system of claim 1, wherein the spectral analysis is a spectral fast Fourier transform (FFT) analysis.

4. The system of claim 3, 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 {F₀, F₁, . . . , 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 {F₀, F₁, . . . , 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 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.

5. The system of claim 4, wherein the baseline peripheral venous pressure frequency spectrum is obtained by:

acquiring, by the at least one pressure sensor, 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.

6. The system of claim 1, further comprising:

a tubing having a first end and an opposite, second end, wherein the first end is connectable to the fluid source, and the second end is connected to the IV catheter; and

a port device in fluid communication with the tubing, located between the first and second ends of the tubing;

wherein the at least one pressure sensor is in fluid communication with the tubing through the port device.

7. An intravenous (IV) system, comprising:

an IV device configured to acquire, from a vein of a living subject, peripheral venous signals; and

a processing device communicatively connected to the IV device, configured to;

receive the peripheral venous signals from the 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 IV line functionality of the IV device in real time, wherein the IV line functionality of the IV device is determined to indicate IV infiltration when amplitude decreases greater than a first threshold are detected from the peaks of the peripheral venous pressure frequency spectrum,

wherein the IV device comprises;

an IV catheter, configured to be inserted into the vein of the living subject;

a tubing having a first end and an opposite, second end, wherein the first end is connectable to a fluid source, and the second end is connected to the IV catheter; and

a fluid controlling device in fluid communication with the tubing, located between the first and second ends of the tubing to control fluid flow from the fluid source to the IV catheter,

wherein the processing device is further configured to, when the IV line functionality of the IV device is determined to indicate IV infiltration, control the fluid controlling device to stop the fluid flow from the fluid source to the IV catheter.

8. The system of claim 7, wherein the processing device is a computing device.

9. The system of claim 7, wherein the spectral analysis is a spectral fast Fourier transform (FFT) analysis.

10. The system of claim 9, 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 {F₀, F₁, . . . , 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 {F₀, F₁, . . . , 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 IV line functionality of the IV device in real time by comparing the amplitudes of the peaks {P_N-1} to that of the baseline peaks {B_N-1} respectively.

11. The system of claim 10, wherein the baseline peripheral venous pressure frequency spectrum is obtained by:

acquiring, by the 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.

12. The system of claim 7, wherein the IV device further comprises:

a port device in fluid communication with the tubing, located between the first and second ends of the tubing; and

at least one pressure sensor in fluid communication with the tubing through the port device, configured to obtain the peripheral venous signals by measuring fluid pressures in the port device.

13. The system of claim 7, wherein the IV infiltration indicates occlusion or malposition of the IV catheter.

14. A method for monitoring an intravenous (IV) line functionality of an IV device, wherein the IV device comprises:

an IV catheter, configured to be inserted into a vein of the living subject;

a tubing having a first end and an opposite, second end, wherein the first end is connectable to a fluid source, and the second end is connected to the IV catheter; and

a fluid controlling device in fluid communication with the tubing, located between the first and second ends of the tubing to control fluid flow from the fluid source to the IV catheter,

the method comprising;

acquiring, from the IV catheter, peripheral venous signals, wherein the IV catheter is configured to be inserted in the vein of the living subject;

performing, by a processing device communicatively connected to the 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 IV line functionality of the IV device in real time; and

when the IV line functionality of the 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 IV catheter.

15. The method of claim 14, wherein the spectral analysis is a spectral fast Fourier transform (FFT) analysis.

16. The method of claim 15, 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 {F₀, F₁, . . . , 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 {F₀, F₁, . . . , 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 IV line functionality of the IV device in real time by comparing the amplitudes of the peaks {P_N-1} to that of the baseline peaks {B_N-1} respectively.

17. The method of claim 15, wherein the baseline peripheral venous pressure frequency spectrum is obtained by:

acquiring the peripheral venous signals from the 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.

18. The method of claim 14, wherein:

the IV line functionality of the IV device is determined to indicate IV infiltration 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 IV infiltration indicates occlusion or malposition of the IV catheter.

20. The method of claim 14, wherein the IV device further comprises:

a port device in fluid communication with the tubing, located between the first and second ends of the tubing; and

at least one pressure sensor in fluid communication with the tubing through the port device, configured to obtain the peripheral venous signals by measuring fluid pressures in the port device.

21. The method of claim 14, wherein the processing device is a computing device.