Medical infusion pump with closed loop stroke feedback system and method

• US 8,313,308 B2
• Filed: 03/26/2004
• Issued: 11/20/2012
• Est. Priority Date: 03/26/2004
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: Hospira Incorporated (Pfizer Inc.)
• Inventors: Lawless, Michael W., Fathallah, Marwan A., Saleki, Mansour A., Kidd, Brian A., Abrahamson, Kent D., Cousineau, Robert P., Boyd, Robert R., Greene, Howard L.
• Primary Examiner(s): Kramer, Devon C
• Assistant Examiner(s): STIMPERT, PHILIP EARL
• Application Number:
  US10/810,123
• Publication Number:
  US 20050214129A1
• Time in Patent Office: 3,161 Days
• Field of Search: 417/44.1, 417/44.2, 417/118, 417/477.2, 417/20, 604/153
• US Class Current: 417/44.2
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/16809 by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

A medical pump with a closed loop stroke feedback system and method, for use with a pumping chamber, for example in a cassette, is disclosed. The pump includes a pumping element that intermittently pressurizes a pumping chamber during a pumping cycle. A pressure sensor detects the pressure exerted by the pumping element on the pumping chamber. A position sensor detects the position of the pumping element. A processing unit processes pressure data from the pressure sensor and position data from the position sensor to determine a calculated stroke volume of the pump for a pump cycle, and to adjust a stroke frequency of the pump to compensate for variation in the stroke volume.

Claims

1. A medical pump for use with a pumping chamber, comprising:

a plunger, disposed between a passive inlet valve and a passive outlet valve of the pumping chamber, adapted to intermittently pressurize the pumping chamber during a pumping cycle, the pumping cycle defining an attempted fluid delivery stroke of the pump;

a pressure sensor directly connected to the plunger and adapted to detect the pressure, between the passive inlet valve and the passive outlet valve, exerted by the plunger on the pumping chamber;

a position sensor operatively associated with the plunger to detect the position of the plunger;

a processing unit in electronic communication with the pressure sensor and position sensor; and

a memory coupled to the processing unit, wherein the memory contains programming code executed by the processing unit to process pressure data from the pressure sensor and position data from the position sensor to determine a calculated actual stroke volume of the pump for the pumping cycle from a beginning of a compression stroke of the pumping cycle to a point when the passive outlet valve opens, and to modify stroke frequency to compensate for variation between the calculated stroke volume and a desired dosage rate; and

wherein the passive outlet valve is operated by the pressure exerted by the plunger on the pumping chamber, and the programming code executed by the processing unit processes pressure data from the pressure sensor to identify when the passive outlet valve has opened.

2. The medical pump of claim 1, wherein the pressure sensor is the only pressure sensor included in the medical pump.

3. The medical pump of claim 1, wherein the programming code executed by the processing unit processes the pressure data and the position data to determine a calculated pressurization volume from the beginning of the compression stroke of the pumping cycle to the point when the passive outlet valve opens, and uses the calculated pressurization volume to determine the calculated stroke volume.

4. The medical pump of claim 3, wherein the programming code executed by the processing unit determines a change in pressurization volume by subtracting the calculated pressurization volume from a nominal pressurization volume, determines a change in stroke volume by multiplying the change in pressurization volume by a ratio of pumping chamber expansion under pressure at the end of the compression stroke to pumping chamber expansion under pressure at the beginning of the compression stroke of the pumping cycle, and determines the calculated stroke volume based on the change in stroke volume.

5. The medical pump of claim 4, wherein the expected nominal pressurization volume comprises multiple nominal pressurization volumes averaged together.

6. The medical pump of claim 4, wherein the programming code executed by the processing unit determines the calculated stroke volume by adding the change in stroke volume to a nominal stroke volume.

7. The medical pump of claim 3, wherein the programming code executed by the processing unit determines the calculated pressurization volume from the beginning of the compression stroke to the point when the passive outlet valve opens by converting an angle at which the passive outlet vale opens to a displacement distance of the plunger by calculating equation x_i=L_cam * (1−

cos(θ

_i)), wherein x_i is the displacement distance, L_cam is half a distance of a stroke of the plunger, and θ

_i is an angular position of the plunger at which the passive outlet valve opens, and converts the displacement distance x_i into the calculated pressurization volume based on a ratio of volume to displacement distance for the pump.

8. The medical pump of claim 7, wherein the programming code executed by the processing unit determines the ratio of the volume to the displacement distance for the pump based on a nominal pressurization volume and a nominal displacement distance for a typical pump.

9. The medical pump of claim 8, wherein the nominal pressurization volume and the nominal displacement distance is provided using empirical evidence of an average normal stroke volume for all pumps of a particular type or for the particular pump.

10. The medical pump of claim 1 further comprising a cassette for defining the pumping chamber.

11. The medical pump of claim 1, wherein the pumping chamber is pressurized for a plurality of attempted fluid delivery strokes and the calculated stroke volume is an average taken over the plurality of attempted fluid delivery strokes.

12. The medical pump of claim 1, wherein the plunger is disposed against a flexible membrane of the pumping chamber between the passive inlet valve and the passive outlet valve, and the plunger is adapted to displace the flexible membrane to compress the pumping chamber and open the passive outlet valve.

13. The medical pump of claim 1, wherein the pressure sensor directly detects the pressure, between the passive inlet valve and the passive outlet valve, exerted by the plunger on the pumping chamber without using any intervening elements between the pressure sensor and the plunger.

14. The medical pump of claim 1, wherein the plunger is the only plunger used to intermittently pressurize the pumping chamber.

15. The medical pump of claim 1, wherein the pressure sensor is positioned outside of the pumping chamber in-line with and directly connected to the plunger between the pumping chamber and a shaft connected to a motor, wherein the shaft is configured to move the plunger against a flexible membrane of the pumping chamber to displace the flexible membrane and intermittently pressurize the pumping chamber during the pumping cycle.

16. The medical pump of claim 1, wherein the programming code executed by the processing unit does not modify the stroke frequency if the calculated stroke volume is not greater than a given threshold value until the calculated stroke volume exceeds the given threshold value.

17. The medical pump of claim 16, wherein the given threshold value is predetermined based on experimental data for a type of the pump or for the particular pump.

18. The medical pump of claim 1, wherein the programming code executed by the processing unit uses closed loop stroke feedback in which the stroke frequency is continually modified to adjust actual fluid delivery to compensate for variation in the stroke volume of fluid being delivered from the beginning of the compression stroke of the pumping cycle to the point when the passive outlet valve opens.

19. The medical pump of claim 1, wherein the memory contains the programming code executed by the processing unit to establish an expected nominal stroke volume associated with the attempted fluid delivery stroke of the pump, set a first stroke frequency based upon the desired dosage rate and the expected nominal stroke volume, thence, during pressurization of the pumping chamber for at least one attempted fluid delivery stroke, process the pressure data from the pressure sensor and the position data from the position sensor to determine a calculated actual stroke volume of the pump for the pumping cycle from the beginning of the compression stroke of the pumping cycle to the point when the passive outlet valve opens, and, if the calculated actual stroke volume is greater than a given threshold value, to modify the first stroke frequency to a second stroke frequency different than the first stroke frequency in order to compensate for variation between the calculated actual stroke volume and the expected nominal stroke volume so as to more closely approachthe desired dosage rate during a subsequent pumping cycle.

20. The medical pump of claim 19, wherein the passive outlet valve is operated by the pressure, between the passive inlet valve and the passive outlet valve, exerted by the plunger on the pumping chamber, and the programming code executed by the processing unit processes the pressure data from the pressure sensor to identify when the passive outlet valve has opened.

21. The medical pump of claim 20, wherein the programming code executed by the processing unit uses closed loop stroke feedback in which the stroke frequency is continually modified to adjust actual fluid delivery to compensate for variation in the actual stroke volume of fluid being delivered from the beginning of the compression stroke of the pumping cycle to the point when the passive outlet valve opens.

22. A medical pump for use with a pumping chamber, comprising:

a plunger, disposed between a passive inlet valve and a passive outlet valve of the pumping chamber, adapted to intermittently pressurize the pumping chamber during a pumping cycle, the pumping cycle defining an attempted fluid delivery stroke of the pump;

a pressure sensor directly connected to the plunger and adapted to detect the pressure, between the passive inlet valve and the passive outlet valve, exerted by the plunger on the pumping chamber;

a position sensor operatively associated with the plunger to detect the position of the plunger;

a processing unit in electronic communication with the pressure sensor and position sensor; and

a memory coupled to the processing unit, wherein the memory contains programming code executed by the processing unit to establish an expected nominal stroke volume associated with the attempted fluid delivery stroke of the pump, set a first stroke frequency based upon a desired dosage rate and the expected nominal stroke volume, thence, during pressurization of the pumping chamber for at least one attempted fluid delivery stroke, process pressure data from the pressure sensor and position data from the position sensor to;

identify by a slope change in the pressure data when the passive outlet valve of the pumping chamber has opened,

determine a calculated pressurization volume from a beginning of the pumping cycle to the point when the passive outlet valve opens,

determine a change in pressurization volume by subtracting the calculated pressurization volume from a nominal pressurization volume,

determine a change in stroke volume by multiplying the change in pressurization volume by a ratio of pumping chamber expansion under pressure at the end of the compression stroke of the pumping cycle to pumping chamber expansion under pressure at the beginning of a compression stroke of the pumping cycle,

determine a calculated actual stroke volume based on the change in stroke volume, and, if the calculated actual stroke volume is greater than a given threshold value,

modify the stroke frequency to a second stroke frequency that is different than the first stroke frequency in order to compensate for variation between the calculated actual stroke volume and the expected nominal stroke volume; and

wherein the passive outlet valve is operated by the pressure, between the passive inlet valve and the passive outlet valve, exerted by the plunger on the pumping chamber.

23. The medical pump of claim 22 further comprising a cassette for defining the pumping chamber.

24. The medical pump of claim 22, wherein the plunger is disposed against a flexible membrane of the pumping chamber between the passive inlet valve and the passive outlet valve, and the plunger is adapted to displace the flexible membrane to compress the pumping chamber and open the passive outlet valve.

25. The medical pump of claim 22, wherein the pressure sensor directly detects the pressure, between the passive inlet valve and the passive outlet valve, exerted by the plunger on the pumping chamber without using any intervening elements between the pressure sensor and the plunger.

26. The medical pump of claim 22, wherein the plunger is the only plunger used to intermittently pressurize the pumping chamber.

27. The medical pump of claim 22, wherein the pressure sensor is positioned outside of the pumping chamber in-line with and directly connected to the plunger between the pumping chamber and a shaft connected to a motor, wherein the shaft is configured to move the plunger against a flexible membrane of the pumping chamber to displace the flexible membrane and intermittently pressurize the pumping chamber during the pumping cycle.

28. A medical pump for use with a cassette having a pumping chamber, comprising:

a plunger, disposed between a passive inlet valve and a passive outlet valve of the pumping chamber, operatively associated with a shaft and adapted to intermittently pressurize the pumping chamber during a pumping cycle, the pumping cycle defining an attempted fluid delivery stroke of the pump;

a pressure sensor positioned outside of the pumping chamber in-line with and directly connected to the plunger between the pumping chamber and the shaft connected to a motor, wherein the shaft is configured to move the plunger against a flexible membrane of the pumping chamber to displace the flexible membrane and intermittently pressurize the pumping chamber during the pumping cycle, the pressure sensor being adapted to detect the pressure, between the passive inlet valve and the passive outlet valve, exerted by the plunger on the pumping chamber;

a position sensor operatively associated with the plunger to detect the position of the plunger;

a processing unit in electronic communication with the pressure sensor and position sensor; and

a memory coupled to the processing unit, wherein the memory contains programming code executed by the processing unit to establish an expected nominal stroke volume associated with the attempted fluid delivery stroke of the pump, set a first stroke frequency based upon a desired pump flow rate and the expected nominal stroke volume, thence, during pressurization of the pumping chamber for at least one attempted fluid delivery stroke, to process pressure data from the pressure sensor and position data from the position sensor to determine a calculated actual stroke volume of the pump for the pumping cycle, and to modify the first stroke frequency to a second stroke frequency different than the first stroke frequency in order to compensate for variation between the calculated actual stroke volume and the expected nominal stroke volume so as to more closely approach the desired pump flow rate for a subsequent pumping cycle; and

wherein the passive outlet valve is operated by the pressure, between the passive inlet valve and the passive outlet valve, exerted by the plunger on the pumping chamber, and the programming code executed by the processing unit processes pressure data from the pressure sensor to identify when the passive outlet valve has opened.

29. The medical pump of claim 28, wherein the flexible membrane of the pumping chamber is disposed between the passive inlet valve and the passive outlet valve, and the plunger is adapted to displace the flexible membrane to compress the pumping chamber and open the passive outlet valve.

30. The medical pump of claim 28, wherein the pressure sensor directly detects the pressure, between the passive inlet valve and the passive outlet valve, exerted by the plunger on the pumping chamber without using any intervening elements between the pressure sensor and the plunger.

31. The medical pump of claim 28, wherein the plunger is the only plunger used to intermittently pressurize the pumping chamber.

32. A medical pump for use with a pumping chamber, comprising:

a plunger, disposed between a passive inlet valve and a passive outlet valve of the pumping chamber, adapted to intermittently pressurize the pumping chamber during a pumping cycle, the pumping cycle defining an attempted fluid delivery stroke of the pump;

a pressure sensor positioned outside of the pumping chamber in-line with and directly connected to the plunger between the pumping chamber and a shaft connected to a motor, wherein the shaft is configured to move the plunger against a flexible membrane of the pumping chamber to displace the flexible membrane and intermittently pressurize the pumping chamber during the pumping cycle, and the pressure sensor is adapted to detect the pressure exerted by the plunger on the pumping chamber;

a position sensor operatively associated with the plunger to detect the position of the plunger;

a processing unit in electronic communication with the pressure sensor and position sensor; and

a memory coupled to the processing unit, wherein the memory contains programming code executed by the processing unit to process pressure data from the pressure sensor and position data from the position sensor to determine a calculated actual stroke volume of the pump for the pumping cycle, and to modify stroke frequency to compensate for variation between the calculated stroke volume and a desired dosage rate; and

wherein the passive outlet valve is operated by the pressure exerted by the plunger on the pumping chamber, and the programming code executed by the processing unit processes pressure data from the pressure sensor to identify when the passive outlet valve has opened.

33. The medical pump of claim 32, wherein the memory contains the programming code executed by the processing unit to establish an expected nominal stroke volume associated with the attempted fluid delivery stroke of the pump, set a first stroke frequency based upon the desired dosage rate and the expected nominal stroke volume, thence, during pressurization of the pumping chamber for at least one attempted fluid delivery stroke, process the pressure data from the pressure sensor and the position data from the position sensor to determine a calculated actual stroke volume of the pump for the pumping cycle, and, if the calculated actual stroke volume is greater than a given threshold, to modify the first stroke frequency to a second stroke frequency different than the first stroke frequency in order to compensate for variation between the calculated actual stroke volume and the expected nominal stroke volume so as to more closely approach the desired dosage rate during a subsequent pumping cycle.

34. The medical pump of claim 33, wherein the pressure sensor is adapted to detect the pressure, between the passive inlet valve and the passive outlet valve, exerted by the plunger on the pumping chamber, and the passive outlet valve is operated by the pressure, between the passive inlet valve and the passive outlet valve, exerted by the plunger on the pumping chamber.

35. A medical pump for use with a pumping chamber, comprising:

a plunger, disposed between a passive inlet valve and a passive outlet valve of the pumping chamber, adapted to intermittently pressurize the pumping chamber during a pumping cycle, the pumping cycle defining an attempted fluid delivery stroke of the pump;

a pressure sensor directly connected to the plunger and adapted to detect the pressure, between the passive inlet valve and the passive outlet valve, exerted by the plunger on the pumping chamber;

a position sensor operatively associated with the plunger to detect the position of the plunger;

a processing unit in electronic communication with the pressure sensor and position sensor; and

a memory coupled to the processing unit, wherein the memory contains programming code executed by the processing unit to process pressure data from the pressure sensor and position data from the position sensor to determine a calculated stroke volume of the pump for the pumping cycle, and, if the calculated stroke volume is greater than a given threshold value, to modify a stroke frequency in order to compensate for variation between the calculated stroke volume and a desired dosage rate and, if the calculated stroke volume is not greater than the given threshold value, does not modify the stroke frequency until the calculated stroke volume exceeds the given threshold value; and

wherein the passive outlet valve is operated by the pressure exerted by the plunger on the pumping chamber, and the programming code executed by the processing unit processes pressure data from the pressure sensor to identify when the passive outlet valve has opened.

36. The medical pump of claim 35, wherein the memory contains the programming code executed by the processing unit to establish an expected nominal stroke volume associated with the attempted fluid delivery stroke of the pump, set a first stroke frequency based upon the desired dosage rate and the expected nominal stroke volume, thence, during pressurization of the pumping chamber for at least one attempted fluid delivery stroke, process the pressure data from the pressure sensor and the position data from the position sensor to determine a calculated actual stroke volume of the pump for the pumping cycle, and, if the calculated actual stroke volume is greater than a given threshold value, to modify the first stroke frequency to a second stroke frequency different than the first stroke frequency in order to compensate for variation between the calculated actual stroke volume and the expected nominal stroke volume so as to more closely approach the desired dosage rate during a subsequent pumping cycle, and, if the calculated actual stroke volume is not greater than the given threshold value, does not modify the first stroke frequency until the calculated actual stroke volume exceeds the given threshold value.

37. The medical pump of claim 36, wherein the passive outlet valve is operated by the pressure, between the passive inlet valve and the passive outlet valve, exerted by the plunger on the pumping chamber.