Medication safety enhancement for secondary infusion

• US 8,672,875 B2
• Filed: 12/31/2003
• Issued: 03/18/2014
• Est. Priority Date: 12/31/2003
• Status: Active Grant

• Current Assignee: Carefusion 303 Incorporated (Becton Dickinson & Co)
• Original Assignee: Carefusion 303 Incorporated (Becton Dickinson & Co)
• Inventors: Vanderveen, Timothy W., Butterfield, Robert D.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US10/750,345
• Publication Number:
  US 20050145010A1
• Time in Patent Office: 3,730 Days
• Field of Search: 137/109, 604/81, 604/67, 604/80
• US Class Current: 604/67
• CPC Class Codes: A61M 2205/3351 Controlling upstream pump pressure
• CPC Class Codes: A61M 5/14212 Pumping with an aspiration and an expulsion action
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: Y10T 137/2554 Reversing or 4-way valve systems
• CPC Class Codes: Y10T 137/2559 Self-controlled branched flow systems

Abstract

A system and method determine when fluid is not flowing properly from a secondary infusion source during a secondary infusion. The system includes an upstream pressure sensor and a processor programmed to receive signals from the sensor and analyze the signals to determine if secondary fluid flow is proper. The processor samples the output signals from the upstream pressure sensor and analyzes the sampled signals to determine if a pressure rise in the infusion line has occurred when the secondary infusion is initiated. If a pressure rise, indicating that fluid from the secondary container has begun flowing into the infusion line, has not been detected, the processor is programmed to provide a signal indicating that attention should be given to the infusion set up.

Claims

1. A method for actively detecting a fault condition in an intravenous (IV) set having a primary line coupled to a first fluid source, a secondary line coupled from a second fluid source to a fitting, upstream of a pumping mechanism, on the primary line, a check valve in the portion of the primary line between the first fluid source and the fitting, a valve in the portion of the secondary line between the second fluid source and the fitting, and a portion of the primary line that is downstream of the fitting being coupled to the pumping mechanism of an infusion pump, the method comprising:

measuring a pressure of a fluid in the primary line at a point between the fitting and the pumping mechanism;

determining a baseline pressure based on the measured pressure;

infusing a bolus of fluid into the primary line between the fitting and the pumping mechanism;

determining a characteristic of an increase in the measured pressure above the baseline pressure subsequent to the infusion of the bolus of fluid;

comparing, using a processor, the determined characteristic with a threshold; and

when the determined characteristic is greater than the threshold, providing an alert indicating a fault condition of the secondary line.

2. The method of claim 1, wherein the step of determining a baseline pressure comprises calculating an average of the measured pressure over an immediately prior period of time.

3. The method of claim 2, wherein the step of infusing a bolus of fluid into the primary line comprises reversing the pumping mechanism so as to withdraw a bolus of fluid from a portion of the primary line that is downstream of the pumping mechanism and infuse the withdrawn bolus into the primary line between the fitting and the pumping mechanism.

4. The method of claim 1, wherein the step of providing an alert comprises notifying a caregiver that the secondary line is blocked.

5. The method of claim 1, wherein the step of determining a characteristic comprises integrating the increase in the measured pressure above the baseline pressure over a period of time.

6. The method of claim 1, wherein the step of determining a characteristic comprises determining a maximum increase in the measured pressure above the baseline pressure.

7. The method of claim 6, wherein the threshold comprises a pressure value, and the step of comparing the determined characteristic to a threshold comprises comparing the maximum increase in the measured pressure to the pressure value.

8. The method of claim 5, wherein the step of providing an alert comprises notifying a caregiver that the valve on the secondary line is closed.

9. The method of claim 5, wherein the threshold comprises a pressure-time value, and the step of comparing the determined characteristic to a threshold comprises comparing the integrated value to the pressure-time value.

10. A system for actively detecting a fault condition in an intravenous (IV) set having a primary line coupled to a first fluid source, a secondary line coupled from a second fluid source to a fitting, upstream of a pumping mechanism, on the primary line, a check valve in the portion of the primary line between the first fluid source and the fitting, a valve in the portion of the secondary line between the second fluid source and the fitting, and a portion of the primary line that is downstream of the fitting being coupled to the pumping mechanism of an infusion pump, the system comprising:

a pumping mechanism operatively coupled to a portion of the primary line that is downstream of the fitting, the pumping mechanism configured to selectably cause a fluid to flow within the primary line;

a pressure sensor operatively coupled to the primary line at a point between the fitting and the pumping mechanism, the pressure sensor configured to measure a pressure of a fluid within the primary line and provide pressure measurements; and

a processor coupled to the pumping mechanism and the pressure sensor, the processor configured to;

receive the pressure measurements from the pressure sensor;

determine a baseline pressure based on the received pressure measurements;

cause the pumping mechanism to selectably infuse a bolus of fluid into the primary line between the fitting and the pumping mechanism;

determine a characteristic of an increase in the received pressure measurements above the baseline pressure;

compare the determined characteristic with a threshold; and

when the determined characteristic is greater than the threshold, indicate a fault condition of the secondary line.

11. The system of claim 10, wherein:

the pumping mechanism is further configured to selectably operate in reverse so as to cause the fluid in the primary line to flow from a portion of the primary line that is downstream of the pumping mechanism into the primary line between the fitting and the pumping mechanism,

wherein causing the pumping mechanism to infuse the bolus of fluid comprises causing the pumping mechanism to operate in reverse for a period of time.

12. The system of claim 11, wherein the bolus of fluid comprises between about 5 microliters to 30 microliters of the fluid.

13. The system of claim 10, wherein the processor being configured to indicate the fault condition comprises processor being configured to provide an alert comprising information regarding the fault condition.

14. The system of claim 13, wherein the information indicates that the secondary line is blocked.

15. The system of claim 14, wherein the information indicates that the valve in the secondary line is closed.

16. The system of claim 10, wherein the characteristic of an increase in the received pressure measurements above the baseline pressure comprises an integration of the increase in the received pressure measurement above the baseline pressure over a period of time, and wherein the threshold comprises a pressure-time value.

17. The system of claim 10, wherein the characteristic of an increase in the received pressure measurements above the baseline pressure comprises a maximum increase in the measured pressure above the baseline pressure, and wherein the threshold comprises a pressure.

18. A method for actively detecting a fault condition in an intravenous (IV) set having a primary line coupled to a first fluid source, a secondary line coupled from a second fluid source to a fitting, upstream of a pumping mechanism on the primary line, a check valve in the portion of the primary line between the first fluid source and the fitting, and a manually operated valve in the portion of the secondary line between the second fluid source and the fitting, and a portion of the primary line that is downstream of the fitting being coupled to the pumping mechanism of an infusion pump, the method comprising:

making a pressure measurement of a fluid in the primary line at a point between the fitting and the pumping mechanism;

reversing the pumping mechanism so as to cause a flow of the fluid from a portion of the primary line that is downstream of the pumping mechanism to flow into the primary line between the fitting and the pumping mechanism for a period of time;

making one or more most-recent pressure measurements during the period of time, each of the one or more most-recent pressure measurements having an associated time of measurement;

determining a pressure threshold for each of one or more most-recent pressure measurements by adding a certain pressure to an average of the pressure measurements made during a respective interval of time that precedes the respective time of measurement;

comparing, using a processor, each of the one or more most-recent pressure measurements with the respective pressure threshold; and

when the comparison indicates that any of the one or more most-recent pressure measurements is greater than or equal to the respective pressure threshold, providing an alert that the manually operated valve in the secondary line is closed.

19. The method of claim 18, further comprising:

after the period of time has elapsed, causing the pumping mechanism to operate in a forward direction so as to cause fluid to flow downstream within the primary line.

20. A method for actively detecting a fault condition in an intravenous (IV) set having a primary line coupled to a first fluid source, a secondary line coupled from a second fluid source to a fitting, upstream of a pumping mechanism, on the primary line, a check valve in the portion of the primary line between the first fluid source and the fitting, a valve in the portion of the secondary line between the second fluid source and the fitting, and a portion of the primary line that is downstream of the fitting being coupled to the pumping mechanism of an infusion pump, the method comprising:

measuring a pressure of a fluid in the primary line at a point between the fitting and the pumping mechanism;

determining a baseline pressure based on the measured pressure;

reducing a volume of a portion of the primary line that is between the fitting and the pumping mechanism;

determining a characteristic of an increase in the measured pressure above the baseline pressure subsequent to the reduction of the volume of the portion of the primary line that is between the fitting and the pumping mechanism;

comparing, using a processor, the determined characteristic with a threshold; and

when the determined characteristic is greater than the threshold, providing an alert indicating a fault condition of the secondary line.