Positive pressure infusion system having downstream resistance measurement capability

• US 7,255,680 B1
• Filed: 10/27/1999
• Issued: 08/14/2007
• Est. Priority Date: 10/27/1999
• Status: Expired due to Term

• Current Assignee: Carefusion 303 Incorporated (Becton, Dickinson & Co)
• Original Assignee: Cardinal Health 303 Incorporated (Cardinal Health, Inc.)
• Inventors: Gharib, James E.
• Primary Examiner(s): Sirmons; Kevin C.
• Assistant Examiner(s): Mehta; Bhisma
• Application Number:
  US09/428,006
• Time in Patent Office: 2,848 Days
• Field of Search: 604/67, 604/113, 604 401- 601, 604/65, 604/131, 604/132, 604/140, 604/141, 607/96, 607/104, 607/105, 607/106, 607/113, 607/114
• US Class Current: 604/67
• CPC Class Codes: A61M 2005/16868 Downstream occlusion sensors
• CPC Class Codes: A61M 5/1483 using flexible bags externally pressurised by fluid pressure
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse

Abstract

A fluid delivery system includes a first fluid container having infusion fluid for a patient. The first fluid container has an outlet and a conduit attached to the outlet. A second fluid container applies pressure to the first fluid container to force fluid out of the first container and into the conduit at a desired flow rate. A pressure sensor is coupled to the second fluid container and a flow sensor is coupled to the conduit. The processor monitors the flow rate and controls the duty cycle of a downstream flow control actuator to maintain the desired flow rate. The processor determines the downstream resistance of the system by varying the flow rate about the selected flow rate, receiving pressure signals from the pressure sensor and flow signals from the flow sensor, and calculating the change in pressure over the change in flow rate to produce the fluid resistance measurement.

Claims

1. An apparatus for pumping infusion fluid from a first fluid container having an output communicating with a conduit, said apparatus comprising:

a second fluid container positioned adjacent to the first fluid container and configured for application of pressure to the first fluid container to expel the fluid from the first fluid container;

a flow control actuator coupled to the conduit for controlling the desired flow rate;

a pressure sensor coupled to the second fluid container adapted to sense pressure in the second fluid container and provide a pressure signal in response to the pressure sensed;

a flow sensor coupled to the conduit and adapted to sense fluid flow in the conduit and provide a flow signal in response to the fluid flow sensed; and

a processor operatively coupled to said second fluid container for controlling said application of pressure and operatively coupled to said flow control actuator for controlling said desired flow rate, wherein said processor is configured to determine the downstream resistance in the conduit by selectively applying a plurality of pressure values to said second fluid container to obtain a plurality of pressure signals from said pressure sensor and a plurality of flow signals from said flow sensor, and wherein said processor computes said downstream resistance using a quotient of the difference between two of said plurality of pressure signals and a corresponding two of said plurality of flow signals.

2. The apparatus of claim 1, further comprising:

a pump coupled to the second fluid container for providing said application of pressure to the second fluid container.

3. The apparatus of claim 2 wherein the pump is responsive to pressure control data from the processor.

4. The apparatus of claim 1, wherein said flow control actuator is coupled to the conduit downstream from the flow sensor.

5. The apparatus of claim 4 wherein the flow control actuator is responsive to flow control data from the processor.

6. The apparatus of claim 1 wherein the second fluid container includes an input, and further comprising a dump valve coupled to the input of the second fluid container.

7. The apparatus of claim 6 wherein the dump valve is responsive to dump valve control data from the processor.

8. The apparatus of claim 1 further comprising a display responsive to the processor for displaying downstream resistance measurements.

9. The apparatus of claim 1 further comprising a user input device, coupled to the processor, for entering desired flow-rate data.

10. The apparatus of claim 1 wherein the processor determines the downstream resistance by controlling the pressure applied to the fluid in the first container to cause a plurality of different flow rates to exist at the output of the first container, receiving the flow data resulting from each flow rate and determining the fluid resistance by processing changes in applied pressure and changes in flow together.

11. The apparatus of claim 1 wherein the processor determines the downstream resistance by setting a plurality of target flow rates, measuring the pressure applied to the fluid in the first container to cause each of the plurality of target flow rates to exist at the output of the first fluid container, receiving the flow data resulting from each target flow rate and determining the fluid resistance by processing changes in applied pressure and changes in flow together.

12. The apparatus of claim 11 wherein the plurality of target flow rates deviate from a mean flow rate by small positive and negative amounts to maintain an average flow rate substantially equal to the mean flow rate.

13. A method for pumping infusion fluid from a collapsible fluid container having an outlet communicating with a conduit, said method comprising:

inflating a pressure bladder located in relation to the collapsible fluid container such that the pressure bladder applies pressure to the collapsible fluid container when the pressure bladder is inflated;

applying a mean pressure within the pressure bladder such that the fluid from the collapsible fluid container is expelled from the outlet at a mean flow rate;

sensing a pressure within the pressure bladder;

sensing a flow rate of fluid in the conduit; and

determining a measure of resistance to fluid flow through the conduit based on the sensed pressure and the sensed flow rate, wherein said determining the measure of resistance comprises;

applying a first pressure within the pressure bladder;

sensing a first fluid-flow rate at the outlet corresponding to the first pressure;

applying a second pressure within the pressure bladder wherein the second pressure is different than the first pressure;

sensing a second fluid-flow rate at the outlet corresponding to the second pressure; and

processing a difference between the first and second pressures together with a difference between the first and second fluid-flow rates.

14. The method of claim 13 wherein one of either the first or second pressure is the mean pressure.

15. The method of claim 13 wherein the first pressure and the second pressure deviate from the mean pressure by a positive amount and a negative amount respectively to maintain an average pressure substantially equal to the mean pressure.

16. A method for pumping infusion fluid from a collapsible fluid container having an outlet communicating with a conduit, said method comprising:

inflating a pressure bladder located in relation to the collapsible fluid container such that the pressure bladder applies pressure to the collapsible fluid container when the pressure bladder is inflated;

applying a mean pressure within the pressure bladder such that the fluid from the collapsible fluid container is expelled from the outlet at a mean flow rate;

sensing a pressure within the pressure bladder;

sensing a flow rate of fluid in the conduit; and

determining a measure of resistance to fluid flow through the conduit based on the sensed pressure and the sensed flow rate, wherein said determining the measure of resistance comprises;

setting a first target flow rate from the collapsible fluid container;

applying a first pressure within the pressure bladder to obtain the first target flow rate;

setting a second target flow rate from the collapsible fluid container different than the first target flow rate;

applying a second pressure within the pressure bladder to obtain the second target flow rate;

processing a difference between the first and second pressures together with a difference between the first and second target flow rates.

17. The method of claim 16 wherein one of either the first or second target flow rates is the mean flow rate.

18. The method of claim 16 wherein the first target flow rate and the second target flow rate deviate from the mean flow rate by a positive amount and a negative amount respectively to maintain an average flow rate substantially equal to the mean flow rate.

19. The method of claim 16 further comprising the steps of maintaining the flow rate substantially constant while determining the measure of resistance.

20. A method for pumping infusion fluid from an infusion pump having a collapsible fluid container in which a medical fluid is stored with an outlet communicating with a conduit and a pressure bladder positioned proximal the collapsible fluid container, said method comprising the steps of:

applying pressure within the pressure bladder to inflate the bladder to an extent such that it contacts and applies pressure to the collapsible fluid container to expel medical fluid from the collapsible fluid container into the conduit to create fluid flow;

measuring pressure within the pressure bladder and providing pressure signals;

measuring actual fluid flow through the conduit, and providing fluid flow signals; and

determining a measure of resistance to fluid flow through the conduit, including processing the pressure signals representative of the pressure within the pressure bladder and processing the flow signals representative of the fluid flow in the conduit, wherein said determining the measure of resistance comprises;

applying a plurality of different pressures to the pressure bladder to cause a plurality of different flow rates to exist at the outlet of the collapsible fluid container;

receiving a pressure signal for each of the plurality of different pressures applied to the pressure bladder;

receiving a flow signal for each of the plurality of different flow rates at the outlet of the collapsible fluid container; and

processing changes in the flow signals and changes in the pressure signals together.

21. The method of claim 20 wherein the step of causing a plurality of different flow rates to exist at the outlet of the collapsible fluid container comprises the step of applying a plurality different pressures within the pressure bladder.

22. The method of claim 20 wherein the step of causing a plurality of different flow rates to exist at the outlet of the collapsible fluid container comprises the steps of:

setting a plurality of different target flow rates; and

for each target flow rate, applying within the pressure bladder, a pressure required to achieve the target flow rate.

23. An apparatus for pumping infusion fluid from a collapsible fluid container having an output communicating with a conduit, said apparatus comprising:

a housing within which is disposed a collapsible fluid container having an output communicating with a conduit;

a pressure bladder positioned within the housing in close proximity to the collapsible fluid container such that when the pressure bladder is inflated it applies pressure to collapse the collapsible fluid container and thereby expel the fluid from the collapsible fluid container into the conduit;

a pressure sensor coupled to the pressure bladder, the pressure sensor adapted to measure pressure in the pressure bladder and provide a pressure signal in response to the pressure within the pressure bladder;

a flow sensor separate from the pressure sensor, the flow sensor coupled to the conduit and adapted to measure fluid flow in the conduit and provide a flow signal in response to the fluid flow;

a flow control actuator coupled to the conduit for setting a desired flow rate; and

a processor operatively coupled to said pressure bladder for controlling the pressure in said pressure bladder and operatively connected to said flow control actuator for controlling the desired flow rate, said processor configured to receive said pressure signal and said flow signal and to determine the resistance to the flow of infusion fluid through the conduit based on a plurality of samples of pressure signals and a corresponding plurality of samples of flow signals.

24. The apparatus of claim 23, wherein said pressure bladder further comprises a pump coupled to the pressure bladder for controlling the pressure within the pressure bladder by inflation of the pressure bladder, the pump operatively connected to the processor and is responsive to pressure control signals from the processor.

25. The apparatus of claim 23, wherein said flow control actuator is coupled to the conduit downstream from the flow sensor, wherein the flow control actuator is responsive to flow control signals from the processor.

26. The apparatus of claim 23 further comprising a dump valve coupled to the pressure bladder, the dump valve operatively connected to the processor and is responsive to dump valve control signals from the processor to reduce pressure in the pressure bladder.

27. The apparatus of claim 23 wherein the processor:

controls the pressure applied by the pressure bladder to the fluid in the collapsible fluid container to cause a plurality of different flow rates to exist at the output of the collapsible fluid container;

receives the flow signals resulting from each of the different flow rates; and

processes changes in applied pressure together with changes in flow signals to determine the measure of downstream resistance.

28. The apparatus of claim 23 wherein the processor:

sets a plurality of target flow rates,

measures the pressure applied to the fluid in the first container to cause each of the plurality of target flow rates to exist at the output of the collapsible fluid container,

receives the flow signals resulting from each target flow rate, and

processes changes in applied pressure and changes in flow together to determine the measure of downstream resistance.

29. A method for pumping infusion fluid from an infusion pump having a collapsible fluid container in which a medical fluid is stored with an outlet communicating with a conduit and a pressure bladder positioned proximal the collapsible fluid container, said method comprising:

setting a desired fluid flow rate through the conduit using a flow control actuator connected to said conduit;

applying a desired pressure within the pressure bladder to inflate the bladder to an extent such that it contacts and applies external pressure to the collapsible fluid container to expel medical fluid from the collapsible fluid container into the conduit;

measuring pressure within the pressure bladder to obtain a pressure signal;

measuring actual fluid flow rate through the conduit at the outlet of the collapsible fluid container to obtain a flow signal; and

determining a measure of resistance to fluid flow through the conduit when said actual fluid flow rate is equivalent to the desired fluid flow rate, wherein said determining the measure of resistance comprises;

applying a plurality of different pressures to the pressure bladder to cause a plurality of different flow rates to exist at the outlet of the collapsible fluid container;

obtaining one of said pressure signal for each of the plurality of different pressures applied to the pressure bladder;

obtaining one of said flow signal for each of the plurality of different flow rates at the outlet of the collapsible fluid container; and

generating said measure of resistance by computing the quotient of the difference in the pressure signals and the difference in the flow signals.

30. The method of claim 29, further comprising:

adjusting the desired pressure applied within the pressure bladder when the actual fluid flow rate is not equivalent to the desired fluid flow rate.

31. The method of claim 29, further comprising:

adjusting the flow control actuator when the actual fluid flow rate is not equivalent to the desired fluid flow rate.

32. The method of claim 29, further comprising:

releasing the pressure applied to the pressure bladder when the pressure contained therein is greater than a threshold pressure level.

33. The method of claim 29, further comprising:

releasing the pressure applied to the pressure bladder when it is desired to stop the infusion.

34. The method of claim 29, further comprising:

displaying the measure of resistance of fluid flow through the conduit.

35. A method for pumping infusion fluid from an infusion pump having a collapsible fluid container in which a medical fluid is stored with an outlet communicating with a conduit and a pressure bladder positioned proximal the collapsible fluid container, said method comprising:

setting a desired fluid flow rate through the conduit using a flow control actuator connected to said conduit;

applying a desired pressure within the pressure bladder to inflate the bladder to an extent such that it contacts and applies external pressure to the collapsible fluid container to expel medical fluid from the collapsible fluid container into the conduit;

measuring pressure within the pressure bladder to obtain a pressure signal;

measuring actual fluid flow rate through the conduit at the outlet of the collapsible fluid container to obtain a flow signal; and

determining a measure of resistance to fluid flow through the conduit when said actual fluid flow rate is equivalent to the desired fluid flow rate, wherein said determining the measure of resistance comprises;

applying a first pressure within the pressure bladder;

sensing a first fluid-flow rate at the outlet corresponding to the first pressure;

applying a second pressure within the pressure bladder wherein the second pressure is different than the first pressure;

sensing a second fluid-flow rate at the outlet corresponding to the second pressure; and

generating said measure of resistance by computing the quotient of the difference between the first and second pressure signals and the difference between the first and second fluid-flow rate signals.

36. The method of claim 35, further comprising:

adjusting the desired pressure applied within the pressure bladder when the actual fluid flow rate is not equivalent to the desired fluid flow rate.

37. The method of claim 35, further comprising:

adjusting the flow control actuator when the actual fluid flow rate is not equivalent to the desired fluid flow rate.

38. The method of claim 35, further comprising:

releasing the pressure applied to the pressure bladder when the pressure contained therein is greater than a threshold pressure level.

39. The method of claim 35, further comprising:

releasing the pressure applied to the pressure bladder when it is desired to stop the infusion.

40. The method of claim 35, further comprising:

displaying the measure of resistance of fluid flow through the conduit.