System and method for detecting abnormalities in intravascular infusion

• US 5,087,245 A
• Filed: 03/13/1989
• Issued: 02/11/1992
• Est. Priority Date: 03/13/1989
• Status: Expired due to Term

• Current Assignee: Carefusion 303 Incorporated (Becton, Dickinson & Co)
• Original Assignee: Ivax Corporation (Teva Pharmaceutical Industries, Ltd.)
• Inventors: Doan, David
• Primary Examiner(s): Howell, Kyle I.
• Assistant Examiner(s): Lacyk, John P.
• Application Number:
  US07/322,291
• Time in Patent Office: 1,065 Days
• Field of Search: 128/DIG. 12, 128/DIG. 13, 604/65-67, 604/246, 604/247
• US Class Current: 604/67
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse
• CPC Class Codes: Y10S 128/12 Pressure infusion

Abstract

The system and method for detecting abnormalities in infusion of parenteral fluid involves producing perturbation of fluid flow by varying the flow rate of the fluid with respect to an equilibrium flow rate, measuring the pressure level, and measuring the pressure of the fluid over a period of time, to determine equilibrium pressure and a pressure response of the fluid to the perturbation, determining an integral of the difference between the equilibrium pressure and the pressure response, determining resistance to fluid flow, determining a second integral of the difference between the pressure response and equilibrium pressure multiplied by time, and determining compliance by dividing the second integral by the first integral. Resistance and compliance values are displayed, and an alarm is generated when the resistance or compliance parameters fall outside of reference ranges.

Claims

1. A system for detecting abnormalities in infusion of parenteral fluid from a parenteral fluid delivery system to a patient comprising:

a) infusion means for producing a perturbation of said fluid flow by varying the rate of fluid flow from an equilibrium flow rate with a specific volume of fluid;

b) sensor means for measuring pressure of said fluid over a period of time and adapted to generate a signal representing a pressure response of said fluid to said perturbation and a signal representing an equilibrium pressure level;

c) first integrator means operatively connected to said sensor means for determining a first integral of the difference between said equilibrium pressure signal and said pressure response signal over time, and for generating a signal representing said first integral;

d) means for determining resistance to said infusion of fluid from the delivery system adapted to scale said first integral signal according to said specific volume, and for producing a signal representing the resistance to fluid flow;

e) second integrator means for determining a second integral by multiplying the difference between said pressure response signal over time and said equilibrium pressure signal by a value representing said time, and integrating the resultant product with respect to said time, and adapted to generate a signal representing said second integral determined; and

f) means responsive to said first and second integrator means for determining compliance of said fluid delivery system by dividing said second integral signal by said first integral signal to produce a signal representing an effective time constant, and by scaling said effective time constant by said previously determined resistance to produce a signal representing compliance of said fluid delivery system.

2. The system of claim 1, further including memory means for receiving and storing reference values corresponding to said resistance, compliance and time constant signals;

comparator means for comparing at least one of said signals with at least one corresponding reference value to determine a difference therebetween; and

output means operatively connected to said comparator means for providing an indication of the value of at least one said difference.

3. The system of claim 2, wherein said output means comprises alarm means.

4. The system of claim 1, further including means for displaying values representative of at least one of said resistance, said compliance, said equilibrium pressure, and said effective time constant.

5. The system of claim 1, wherein said means for measuring pressure includes means for determining said equilibrium pressure from at least one measurement of pressure at a time when said fluid is not perturbed.

6. The system of claim 1, wherein said first integrator means is adapted to determine said first integral during a period of time in which said pressure response of said fluid is being measured.

7. The system of claim 1, wherein said second integrator means is adapted to determine said second integral during a period of time in which said pressure response of said fluid is being measured.

8. The system of claim 1, wherein said infusion means is adapted to produce a series of pulses of said fluid with periods of zero flow intervening between said pulses.

9. The system of claim 1, wherein said infusion means is adapted to increase said fluid flow to a rate above an original rate of flow at said equilibrium pressure for a predetermined period of time and return said rate of flow to said original rate of flow.

10. The system of claim 1, wherein said infusion means is adapted to decrease said fluid flow to a rate below an original rate of flow at said equilibrium pressure for a predetermined period of time and return said rate of flow to said original rate of flow.

11. The system of claim 1, wherein said infusion means is adapted to increase said fluid flow rate above an original rate of flow at said equilibrium pressure, allow said fluid flow rate to return to a said original rate of flow, decrease said fluid flow rate below said original rate of flow, and return said rate of flow to said original rate of flow.

12. The system of claim 1, wherein said infusion means is adapted to produce a cyclic perturbation of said fluid flow, and to vary the character of cycles in said cyclic perturbation in a predetermined manner.

13. The system of claim 7, further including means connected to said second integrator means for generating a signal representing an effective constant time by dividing said second integral signal by said period of time in which said pressure response is measured.

14. The system of claim 1, including means adapted to receive said resistance signal, said compliance signal, said equilibrium pressure signal, and said effective time constant signal, for comparing said signals taken together with a pattern of corresponding reference signals, and for determining a total pattern of deviation of said signals from said pattern of reference signals, and for generating an alarm when said deviation pattern is outside a predetermined range of values.

15. The system of claim 1, wherein said first and second integrator means are microprocessor means.

16. The system of claim 1, wherein said first and second integrator means are electrical analog means.

17. The system of claim 1, wherein said infusion means includes positive displacement pump.

18. The system of claim 1, wherein said infusion means includes a peristaltic pump.

19. The system of claim 1, wherein said infusion means includes a variable duty cycle controller.

20. The system of claim 1 wherein the compliance determining means subtracts a flow factor which is proportional to the time of flow perturbation of the specific volume of fluid from the quotient of the second integral divided by the first integral prior to sealing the quotient by the resistance.

21. The system of claim 20 wherein the compliance determining means determines the flow factor by dividing an integral of the difference between the equilibrium flow and the flow perturbation over time into an integral of the time multiplied by the difference between the equilibrium flow and the flow perturbation over time.

22. The system of claim 1 wherein said first and second integrals are determined over a time period extending until the fluid flow returns to equilibrium.

23. The method of detecting abnormalities in infusion of parenteral fluid from a parenteral fluid delivery system to a patient, the delivery system having an equilibrium flow rate, comprising the steps of:

a) producing a perturbation of said fluid flow by varying the rate of fluid flow from an equilibrium flow rate with a specific volume of fluid;

b) measuring the pressure of said fluid over a period of time, generating a signal representing an equilibrium pressure level, and generating a signal representing a pressure response of said fluid to said perturbation;

c) determining a first integral of the difference between said equilibrium pressure signal and said pressure response signal over time, and generating a signal representing said first integral;

d) determining resistance to fluid flow in the delivery system by scaling said first integral according to said specific volume, and generating a signal representing resistance to fluid flow;

e) determining a second integral by multiplying the difference between said pressure response signal over time and said equilibrium pressure signal by a value representing said time, and integrating the resultant product with respect to said time, and generating a signal representing said second integral; and

f) determining compliance of the fluid delivery system by dividing said second integral signal by said first integral signal to produce a signal representing an effective time constant of said fluid delivery system and scaling said time constant signal by said previously determined resistance to produce a signal representing compliance of said fluid delivery system.

24. The method of claim 23, further including the steps of comparing at least one of said signals with at least one corresponding reference value to determine a difference between said signal and said reference value;

and generating an alarm signal when said difference is greater than a predetermined alarm value.

25. The method of claim 23, further including the step of displaying values representing at least one of said resistance, said compliance, said equilibrium pressure, and said effective time constant.

26. The method of claim 23, wherein the step of measuring pressure includes determining said equilibrium pressure from at least one measurement of pressure at a time when said fluid is not perturbed.

27. The method of claim 23, wherein said first integral is determined during a period of time in which said pressure response of said fluid is being measured.

28. The method of claim 23, wherein said second integral is determined during a period of time in which said pressure response of said fluid is being measured.

29. The method of claim 23, wherein said perturbation of said fluid flow is produced by a series of pulses of said fluid with periods of zero flow intervening between said pulses.

30. The method of claim 23, wherein perturbation of said fluid flow is produced by increasing said fluid flow to a rate above an original rate of flow at said equilibrium pressure for a predetermined period of time, and returning said rate of flow to said original rate of flow.

31. The method of claim 23, wherein said perturbation of fluid flow is produced by decreasing said fluid flow to a rate below an original rate of flow at said equilibrium pressure for a predetermined period of time, and returning said rate of flow to said original rate of flow.

32. The method of claim 23, wherein said perturbation of fluid flow is produced by increasing said fluid flow rate above an original rate of flow at said equilibrium pressure for a predetermined period of time, allowing said fluid flow rate to return to said original flow rate, decreasing said fluid flow rate below said original rate of flow for a second predetermined of time, and returning said rate of flow to said original rate of flow.

33. The method of claim 23, wherein said perturbation of fluid flow is a cyclic perturbation, and the character of cycles in said cyclic perturbation is varied in a predetermined manner.

34. The method of claim 23, wherein said resistance signal, said effective compliance signal, said equilibrium pressure signal and said effective time constant signal are compared as a group with a pattern of corresponding reference signals, a total pattern of deviation of said signals from said pattern of said reference signals is determined, and an alarm is generated when said deviation pattern falls outside a predetermined set of value ranges.

35. The method of claim 23 wherein the step of determine compliance further includes subtracting a flow factor which is proportional to the time of flow perturbation of the specific volume of fluid from the quotient of the second integral divided by the first integral prior to scaling the quotient by the resistance.

36. The method of claim 35 wherein the step of determining compliance comprises the step of determining the flow perturbation over time into an integral of the time multiplied by the difference between the equilibrium flow and the flow perturbation over time.

37. The method of claim 23 wherein the steps of determining the first and second integrals comprise determining said integrals over a time period extending until the fluid flow returns to equilibrium.

38. A system for determining compliance in infusion of a fluid to a patient by a fluid delivery system, the fluid delivery system having an equilibrium flow rate, comprising:

a) an infusion pump for producing a perturbation in said fluid flow by varying the rate of fluid flow from the equilibrium flow rate with a specific volume of fluid;

b) a pressure sensor for measuring the pressure of the fluid in the fluid delivery system over a period of time and adapted to provide a perturbation pressure signal representing the pressure response of said fluid to said perturbation and an equilibrium pressure signal representing an equilibrium fluid pressure;

c) a resistance calculator for determining the resistance to the infusion of fluid and providing a resistance signal representative thereof;

d) a first integrator which receives the perturbation pressure signal and the equilibrium pressure signal and determines a first integral of the difference between said equilibrium pressure signal and said perturbation pressure signal over time, and for providing a pressure difference signal representative thereof; and

e) a compliance calculator which receives the perturbation pressure signal and the equilibrium pressure signal and determines a second integral by multiplying the difference between the perturbation pressure signal and said equilibrium pressure signal over time by a value representing said time, and integrating the resultant product with respect to said time, and adapted to provide a compliance signal representing said second integral divided by said first integral, the quotient of which is divided by the resistance signal.

39. The system of claim 38 in which the resistance signal is provided by dividing the pressure difference signal by the specific volume of fluid.

40. The system of claim 38 wherein said first and second integrals are determined over a time period extending until the fluid flow returns to equilibrium.

41. The system of claim 38 further comprising an alarm comparator which receives the compliance signal and compares it to a predetermined threshold value and provides an alarm signal based on the comparison.

42. The system of claim 38 wherein the compliance calculator subtracts a flow factor which is proportional to the time of flow perturbation of the specific volume of fluid from the quotient of the second integral divided by the first integral prior to scaling the quotient by the resistance.

43. The system of claim 42 wherein the compliance calculator determines the flow factor by dividing an integral of the difference between the equilibrium flow and the flow perturbation over time into an integral of the time multiplied by the difference between the equilibrium flow and the flow perturbation over time.

44. A system for detecting abnormalities in infusion of fluid to a patient from a fluid delivery system, the fluid delivery system having an equilibrium flow rate, comprising:

a) an infusion pump for producing a perturbation in said fluid flow by varying the rate of fluid flow from the equilibrium flow rate with a specific volume of fluid;

b) a pressure sensor for measuring the pressure of the fluid in the fluid delivery system over a period of time and adapted to provide a perturbation pressure signal representing the pressure response of said fluid to said perturbation and an equilibrium pressure signal representing an equilibrium fluid pressure;

c) a resistance calculator for determining the resistance to the infusion of fluid and providing a resistance signal representative thereof;

d) a first integrator which receives the perturbation pressure signal and the equilibrium pressure signal and determines a first integral of the difference between said equilibrium pressure signal and said perturbation pressure signal over time, and for providing a pressure difference signal representative thereof;

e) a compliance calculator which receives the perturbation pressure signal and the equilibrium pressure signal and determines a second integral by multiplying the difference between the perturbation pressure signal and said equilibrium pressure signal over time by a value representing said time, and integrating the resultant product with respect to said time, and adapted to provide a compliance signal representing said second integral divided by said first integral, from the quotient of which is subtracted a flow factor which is proportional to the time of flow perturbation of the specific volume of fluid, all of which is divided by the resistance signal; and

f) an alarm comparator which receives the resistance signal and compares it to a threshold value and provides an alarm based on the comparison and receives the compliance signal and compares it to a threshold value and provides an alarm signal based on the comparison.

45. The system of claim 44 in which the resistance signal is provided by dividing the pressure difference signal by the specific volume of fluid.

46. The system of claim 45 wherein the first and second integrals are determined over a time period extending until the fluid flow returns to equilibrium.

47. The system of claim 44 wherein the first and second integrals are determined over a time period extending until the fluid flow returns to equilibrium.