Medication safety enhancement for secondary infusion

• US 9,039,656 B2
• Filed: 01/22/2014
• Issued: 05/26/2015
• 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): Lucchesi, Nicholas
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US14/161,661
• Publication Number:
  US 20140142545A1
• Time in Patent Office: 489 Days
• Field of Search: 604/67, 604/81, 604/80, 137/109
• 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 passively 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:

determining with a processor a window of time around an initiation time of a secondary infusion mode;

generating a series of pressure measurements by measuring a pressure of a fluid in the primary line at a point between the fitting and the pumping mechanism at periodic intervals;

generating one or more most-recent pressure measurements by measuring the pressure of the fluid in the primary line at the point between the fitting and the pumping mechanism within the window of time;

calculating a threshold pressure for each of the one or more most-recent pressure measurements based on the series of pressure measurements prior to the respective most-recent pressure measurement;

comparing the each of the one or more most-recent pressure measurements to the respective threshold pressure; and

indicating a fault condition if none of the one or more most-pressure measurement exceeds the threshold within the window of time.

2. The method of claim 1, wherein the series of pressure measurements generated by measuring a pressure of a fluid in the primary line at a point between the fitting and the pumping mechanism at periodic intervals is generated prior to the initiation time of the secondary infusion mode.

3. The method of claim 1, wherein second fluid source is elevated higher than the first fluid source by a certain elevation.

4. The method of claim 3, wherein a pressure of the fluid in the portion of the primary line that is downstream of the fitting is proportionately greater than a pressure of the fluid in the secondary line according to the certain elevation.

5. The method of claim 4, wherein the pressure of the fluid in the portion of the primary line that is downstream of the fitting is approximately 16 mmHg more than the pressure of the fluid in the secondary line.

6. The method of claim 1, wherein the threshold pressure for each of the one or more most-recent pressure measurements is equal to a sum of a respective one of the series of pressure measurements with a threshold offset constant.

7. The method of claim 6, wherein the threshold offset constant is at least 7 mmHg.

8. The method of claim 1, wherein each of the series of pressure measurements comprises a pressure sampled for a period of time and averaged via low pass filter.

9. The method of claim 1, wherein the series of pressure measurements is regularly updated prior to the initiation time of the secondary infusion mode.

10. The method of claim 1, further comprising indicating the fault condition if each of the one or more most-pressure measurement exceeds the threshold for greater than the window of time.

11. A system for passively 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;

determine a window of time around an initiation time of a secondary infusion mode;

generate a series of pressure measurements by measuring a pressure of a fluid in the primary line at a point between the fitting and the pumping mechanism at periodic intervals;

generate one or more most-recent pressure measurements by measuring the pressure of the fluid in the primary line at the point between the fitting and the pumping mechanism within the window of time;

calculate a threshold pressure for each of the one or more most-recent pressure measurements based on the series of pressure measurements prior to the respective most-recent pressure measurement;

compare the each of the one or more most-recent pressure measurements to the respective threshold pressure; and

indicate a fault condition if none of the one or more most-pressure measurement exceeds the threshold within the window of time.

12. The system of claim 11, wherein the series of pressure measurements generated by measuring a pressure of a fluid in the primary line at a point between the fitting and the pumping mechanism at periodic intervals is generated prior to the initiation time of the secondary infusion mode.

13. The system of claim 11, wherein second fluid source is elevated higher than the first fluid source by a certain elevation.

14. The system of claim 13, wherein a pressure of the fluid in the portion of the primary line that is downstream of the fitting is proportionately greater than a pressure of the fluid in the secondary line according to the certain elevation.

15. The system of claim 14, wherein the pressure of the fluid in the portion of the primary line that is downstream of the fitting is approximately 16 mmHg more than the pressure of the fluid in the secondary line.

16. The system of claim 11, wherein the threshold pressure for each of the one or more most-recent pressure measurements is equal to a sum of a respective one of the series of pressure measurements with a threshold offset constant.

17. The system of claim 16, wherein the threshold offset constant is at least 7 mmHg.

18. The system of claim 11, wherein each of the series of pressure measurements comprises a pressure sampled for a period of time and averaged via low pass filter.

19. The system of claim 11, wherein the series of pressure measurements is regularly updated prior to the initiation time of the secondary infusion mode.

20. The system of claim 11, wherein the processor is also configured to indicate the fault condition if each of the one or more most-pressure measurement exceeds the threshold for greater than the window of time.