Detection of fluid flow faults in the parenteral administration of fluids

• US 4,710,163 A
• Filed: 06/06/1986
• Issued: 12/01/1987
• Est. Priority Date: 06/06/1986
• Status: Expired due to Term

• Current Assignee: ALARIS Medical Systems, Inc. (Becton, Dickinson & Co)
• Original Assignee: Ivax Corporation (Teva Pharmaceutical Industries, Ltd.)
• Inventors: Butterfield, Robert D.
• Primary Examiner(s): Coven, Edward M.
• Application Number:
  US06/872,086
• Time in Patent Office: 543 Days
• Field of Search: 128/DIG. 13, 604/50, 604/65, 604/66, 604/67, 604/245, 137/551, 137/557
• US Class Current: 604/65
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

This invention is directed to a method and system for evaluating the fluid communication between a parenteral fluid delivery system and a patient'"'"'s blood vessel. In accordance with the invention, one or more fluid flow pulses are applied to the fluid within the delivery system. Both positive and negative fluid flow pulses may be applied. The pressure response to the pulses under conditions of normal, unimpeded fluid flow is significantly different than the pressure response to such pulses when an infiltration or other fluid flow fault has occurred and this difference is used to detect fluid faults.

Claims

1. A system for monitoring the flow of parenteral fluid through a parenteral fluid delivery system to a patient wherein the fluid in the delivery system is at a base level of pressure or flow rate, the system comprising:

(a) means to apply to fluid in the fluid delivery system a fluid flow excitation pulse which is at a pressure or flow rate significantly greater or lesser than the base level of pressure or flow rate of fluid therein;

(b) means to sense the pressure response of fluid in the delivery system to the applied excitation pulse and generate a signal representing the response or characteristic thereof;

(c) means to generate a reference signal representing a pressure response or characteristic thereof of fluid in the delivery system to a fluid flow excitation pulse of a magnitude and duration equivalent to the fluid flow excitation pulse applied in (a) above when fault-free fluid flow conditions into the patient exist;

(d) means to compare the signal representing the sensed pressure response or characteristic thereof with the signal representing the reference pressure response or characteristic thereof to detect a difference therebetween; and

(e) means responsive to the difference to generate an alarm signal.

2. The system of claim 1 wherein means responsive to the difference is actuated when the difference between the sensed pressure response signal and the reference pressure response signal exceeds a predetermined amount, the predetermined difference therebetween selected to indicate improper fluid communication between the fluid delivery system and the patient.

3. The system of claim 1 wherein means are provided to determine the differences between a first pressure-time curve representing the sensed pressure response and a second pressure-time curve representing the reference pressure response, the differences representing a numerical integration of the area between the two pressure-time curves.

4. The system of claim 3 wherein the differences are summed absolute values.

5. The system of claim 4 wherein the differences are determined from the equation ##EQU3## wherein S(t) is the value of the sensed pressure response at time t;

R(t) is the value of the reference pressure response at time t.

6. The method of claim 3 wherein the pressure or flow rate of the excitation pulse is at least 15 percent greater than or less than the base level pressure or flow rate of the fluid in the fluid delivery system.

7. The method of claim 3 wherein the pressure or flow rate of the excitation pulse is at least greater than 20 percent greater than or less than the base level pressure or flow rate of the fluid in the fluid delivery system.

8. The system of claim 1 wherein means to apply a fluid flow pulse include means to generate a negative fluid flow pulse to fluid in the fluid delivery system.

9. The system of claim 5 including means to determine the short-term fluid pressure variations, identified as noise, of fluid in the fluid delivery system prior to the application of the fluid flow pulse.

10. The system of claim 9 including means to calculate a factor representing a measure of infiltration (MOI) from the equation:

##EQU4## wherein;

SMOE is the subtractive measure of error as calculated in claim 5;

Noise is the short-term fluid pressure variations as determined in claim 9, and

K is a constant or zero.

11. The system of claim 10 wherein the constant K is 1.

12. The system of claim 1 wherein the fluid delivery system includes a pulsatile pump to pump perenteral fluid through the delivery system to the patient.

13. The system of claim 1 wherein means to apply a fluid flow pulse to the fluid delivery system includes means to generate positive and negative fluid flow pulses to fluid in the fluid delivery system.

14. The system of claim 1 wherein the pressure or flow rate of the excitation pulse is at least 15 percent greater than or less than the base level pressure or flow rate of the fluid in the fluid delivery system.

15. The system of claim 1 wherein the pressure or flow rate of the excitation pulse is at least greater than 20 percent greater than or less than the base level pressure or flow rate of the fluid in the fluid delivery system.

16. A method of monitoring the flow of parenteral fluid through a fluid delivery system to a patient, wherein the fluid in the delivery system is at a base level of pressure or flow rate, the method comprising:

(a) applying to fluid in the fluid delivery system a fluid flow excitation pulse at a pressure or flow rate significantly greater or lesser than the base level of pressure or flow rate of fluid therein;

(b) sensing the pressure response of fluid in the fluid delivery system to the applied excitation pulse and generating a signal representing the pressure response sensed or characteristic thereof;

(c) generating a reference signal representing a pressure response or characteristic thereof of fluid in the fluid delivery system having to a fluid flow excitation pulse of a magnitude and duration equivalent to the fluid flow excitation pulse applied in (a) above when fault-free fluid flow conditions into the patient exist;

(d) comparing the signal representing the sensed response or characteristic thereof with the signal representing the reference pressure response or characteristic thereof to detect a difference therebetween; and

(e) generating an alarm signal when the sensed response signal differs from the reference response signal in a predetermined manner, the predetermined difference therebetween indicating the nature of the fluid communication between the fluid delivery system and the patient.

17. The method of claim 16 wherein the transient pressure response to an applied pulse of the same magnitude as the excitation pulse under normal fluid flow conditions is calculated from a mathematical model of the fluid delivery system and the injection site.

18. The method of claim 16 wherein the excitation pulse is applied to the fluid in the fluid delivery system by adjusting the fluid flow rate therein to a higher or a lower level.

19. The method of claim 16 wherein the excitation pulse applied to the fluid in the fluid delivery system is in a direction opposite to the direction of the normal fluid flow through the delivery system to the patient.

20. The method of claim 16 wherein the excitation pulse is a series of positive and negative fluid flow pulses which form a fluid flow pattern which is sinusoidal.