Method for compensating for pressure differences across valves in cassette type IV pump

• US 6,497,680 B1
• Filed: 12/17/1999
• Issued: 12/24/2002
• Est. Priority Date: 12/17/1999
• Status: Expired due to Term

• Current Assignee: ICU Medical Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Maske, Rudolph J., Krajewski, David A., Holst, Peter A.
• Primary Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US09/464,812
• Time in Patent Office: 1,103 Days
• Field of Search: 604/65-67, 604/151-153, 604/132, 128/DIG.12, 128/DIG.13, 417/53, 417/63, 417/282-285, 417/474, 417/477.2
• US Class Current: 604/153
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• 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 5/16827 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 5/365 Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626
• CPC Class Codes: G05D 16/2046 the plurality of throttling means being arranged for the control of a single pressure from a plurality of converging pressures G05D16/204 takes precedence

Abstract

A pump used to infuse a fluid into a patient is controlled in accordance with an algorithm that enables a microprocessor to monitor and adjust each pump cycle to compensate for a differential pressure between the pump'"'"'s inlet and outlet. The algorithm defines a fluid delivery protocol that is applied in controlling the operation of the pump to achieve a desired rate, volume, and timing of the fluid infusion. Fluid is delivered by the pump when a plunger compresses an elastomeric membrane overlying a fluid chamber. Due to the small volume of the chamber, an incremental change in the plunger position before the delivery stroke produces a significant change in the delivery pressure. At the beginning of a pump cycle, the microprocessor determines the differential pressure between the inlet and outlet of the pump, and adjusts the plunger position before the delivery stroke to compensate for the differential pressure. A retraction of the plunger from the home position decreases the delivery pressure of the fluid, and an advancement of the plunger increases it. After the position of the plunger is adjusted to compensate for the differential pressure, the pump cycle proceeds. Following the plunger stroke, the outlet pressure is used to determine the actual volume of fluid delivered. The duration of the plunger stroke in the next pump cycle is adjusted to compensate for any volume delivery error produced by the differential pressure compensation.

Claims

1. A pump employed to infuse a fluid flowing from a source into a patient, comprising:

(a) a disposable cassette having a housing that defines a fluid path from an inlet port that is adapted to couple in fluid communication with the source, to an outlet port that is adapted to couple in fluid communication with an infusion site on the patient, said fluid path including;

(i) a chamber covered by an elastomeric membrane that when forced into the chamber, displaces the fluid from the chamber through the outlet port, said chamber including a pressure sensor that produces a signal indicative of a pressure in the chamber

(ii) an inlet valve controlling flow of the fluid into the chamber from the inlet port, said inlet valve being open as fluid flows into the chamber from the inlet port and closed as the fluid is displaced through the outlet port; and

(iii) an outlet valve controlling flow of the fluid from the chamber toward the outlet port, said outlet valve being open when the fluid is displaced through the outlet port and closed as the fluid flows into the chamber from the inlet port;

(b) a drive unit adapted to couple with disposable cassette and including at least one prime mover and a plunger, said at least one prime mover moving the plunger relative to the chamber to deform the elastomeric membrane, thereby displacing fluid from the chamber toward the outlet port, said drive unit also actuating the inlet valve and outlet valve to open and close said valves; and

(c) a control unit, coupled to receive the signals from the pressure sensor, and coupled to the drive unit to control said at least one prime mover and thereby controlling movement of the plunger, said control unit determining a differential pressure from the signals produced by the pressure sensor and adjusting an initial position of the plunger relative to the chamber before the plunger displaces the fluid from the chamber, to compensate for the differential pressure, so that an accuracy of the pump in infusing the fluid into the patient is substantially improved.

2. A method for determining a difference between a targeted intake fluid volume and an actual intake fluid volume in an infusion pump employed for infusing a fluid into a patient, comprising the steps of:

(a) providing a cassette having a housing that defines a fluid path between an inlet port adapted to couple in fluid communication with a source and an outlet port adapted to couple in fluid communication with an infusion site on the patient, said fluid path including;

(i) a chamber covered by an elastomeric membrane that when forced into the chamber by a driven member displaces the fluid from the chamber through the outlet port;

(ii) an inlet valve controlling a flow of the fluid into the chamber from the inlet port, said inlet valve being open as the fluid flows into the chamber from the inlet port and closed as the fluid is displaced through the outlet port;

(iii) a pressure sensor that produces a signal indicative of a pressure in the chamber; and

(iv) an outlet valve controlling a flow of the fluid from the chamber toward the outlet port, said outlet valve being open when the fluid is displaced through the outlet port and closed as the fluid flows into the chamber from the inlet port;

(b) opening the inlet valve while the outlet valve is closed, and while the inlet valve is open, moving the driven member to a first position such that the elastomeric membrane adjusts a volume of the chamber to correspond to the targeted intake volume, thus filling the chamber with fluid;

(c) determining a first pressure in the pumping chamber using the pressure sensor;

(d) moving the driven member to a second position such that the elastomeric membrane is forced into the chamber, thus decreasing the volume of the chamber, the pressure sensor determining a second pressure in the pumping chamber that exceeds the first pressure by a predetermined amount;

(e) determining the actual intake fluid volume as a function of the first pressure, the second pressure, the first position of the driven member, and the second position of the driven member; and

(f) determining a difference between the targeted intake fluid volume and the actual intake fluid volume.

3. A method for determining a difference between a targeted delivery fluid volume and an actual delivery fluid volume in an infusion pump employed for infusing a fluid into a patient, comprising the steps of:

(a) providing a cassette having a housing that defines a fluid path between an inlet port adapted to couple in fluid communication with a source and an outlet port adapted to couple in fluid communication with an infusion site on the patient, including an outlet pressure sensor that produces a signal indicative of a pressure proximate the outlet port, said fluid path including;

(i) a chamber covered by an elastomeric membrane that when forced into the chamber by a driven member displaces the fluid from the chamber through the outlet port;

(ii) an inlet valve controlling a flow of the fluid into the chamber from the inlet port, said inlet valve being open as the fluid flows into the chamber from the inlet port and closed as the fluid is displaced through the outlet port; and

(iii) an outlet valve controlling a flow of the fluid from the chamber toward the outlet port, said outlet valve being open when the fluid is displaced through the outlet port and closed as the fluid flows into the chamber from the inlet port;

(b) opening the outlet valve while the inlet valve is closed, and while the outlet valve is open, determining a first pressure proximate the outlet port using the outlet pressure sensor;

(c) moving the driven member to a first position such that the elastomeric membrane reduces a volume of the chamber to correspond to the targeted delivery volume, thus emptying the chamber of fluid;

(d) determining a second pressure proximate the outlet port using the outlet pressure sensor;

(e) closing the outlet valve while the inlet valve is still closed, and then opening the inlet valve while the outlet valve is closed;

(f) while the inlet valve is open, moving the driven member to a second position such that the elastomeric membrane expands a volume of the chamber to correspond to the targeted delivery volume, thus filling the chamber with fluid;

(g) determining the actual delivery fluid volume as a function of the first pressure proximate the outlet port, the second pressure proximate the outlet port, the first position of the driven member, and the second position of the driven member; and

(h) determining a difference between the targeted delivery fluid volume and the actual delivery fluid volume.

4. A method for adjusting at least one parameter of an infusion pump for infusing a fluid into a patient, to maintain an accurate delivery of the fluid, compromising the steps of:

(a) providing a cassette having a housing that defines a fluid path between an inlet port adapted to couple in fluid communication with a source and an outlet port adapted to couple in fluid communication with an infusion site on the patient, said fluid path including a chamber from which fluid is displaced through the outlet port;

(b) monitoring at least one of an inlet pressure proximate the inlet port and an outlet pressure proximate the outlet port;

(c) providing a drive unit adapted to couple with the cassette and including a plunger that displaces the fluid from the chamber through the outlet port;

(d) determining an adjustment to an initial position of the plunger relative to the chamber before the plunger displaces the fluid from the chamber, to compensate for a differential pressure between the inlet pressure and the outlet pressure;

(e) changing a position of the plunger relative to the chamber before the plunger begins to displace the fluid from the chamber, in accord with the adjustment to the initial position determined in the preceding step;

(f) determining an actual volume of fluid delivered in a current pump cycle;

(g) determining a change in a duration of a delivery stroke of the plunger required to compensate for any difference between the actual volume of fluid delivered and a desired volume of fluid to be delivered;

(h) applying a change in the duration of the delivery stroke during the next pump cycle; and

wherein the step of determining the change in the duration of a delivery stroke comprises the steps of;

(1) using lookup tables to determine a plunger extend position as a function of an outlet differential pressure, and an error volume at a plunger home position as a function of the inlet pressure; and

(2) determining the duration of the delivery stroke in the next pump cycle required to maintain a desired delivery rate as a function of a time when a previous extend stroke was completed, a time a current extend stroke began, a nominal stroke volume, a user specified delivery rate, a nominal extend stroke position, a plunger corrected position prior to the extend stroke, the plunger extend position, and the error volume.

5. A pump employed to infuse a fluid flowing from a source into a patient, comprising:

(a) a disposable cassette having a housing that defines a fluid path from an inlet port that is adapted to couple in fluid communication with the source, to an outlet port that is adapted to couple in fluid communication with an infusion site on the patient, and including an inlet pressure sensor that produces a signal indicative of a pressure proximate the inlet port, and an outlet pressure sensor that produces a signal indicative of a pressure proximate the outlet port, said fluid path including;

(i) a chamber covered by an elastomeric membrane that when forced into the chamber, displaces the fluid from the chamber through the outlet port;

(ii) an inlet valve controlling flow of the fluid into the chamber from the inlet port, said inlet valve being open as fluid flows into the chamber from the inlet port and closed as the fluid is displaced through the outlet port; and

(iii) an outlet valve controlling flow of the fluid from the chamber toward the outlet port, said outlet valve being open when the fluid displaced through the outlet port and closed as the fluid flows into the chamber from the inlet port;

(b) a drive unit adapted to couple with the disposable cassette and including at least one prime mover and a plunger, said at least one prime mover moving the plunger relative to the chamber to deform the elastomeric membrane, thereby displacing fluid from the chamber toward the outlet port, said drive unit also actuating the inlet valve and outlet valve to open and close said valves; and

(c) a control unit, coupled to receive the signals from the inlet pressure sensor and the outlet pressure sensor, and coupled to the drive unit to control said at least one prime mover and thereby controlling movement of the plunger, said control unit determining a differential pressure from the signals produced by the inlet pressure sensor and the outlet pressure sensor and adjusting an initial position of the plunger relative to the chamber before the plunger displaces the fluid from the chamber, to compensate for the differential pressure, so that an accuracy of the pump in infusing the fluid into the patient is substantially improved.

6. The pump of claim 5, wherein the adjustment to the initial position of the plunger changes a pressure of the fluid in the chamber before the outlet valve is opened to enable the fluid to be displaced from the chamber.

7. The pump of claim 5, wherein as a function of the adjustment to the initial position of the plunger, the control unit changes a duration of time for the fluid to be displaced from the chamber by the plunger.

8. The pump of claim 5, wherein the plunger is always in contact with the elastomeric membrane during the pump cycle.

9. The pump of claim 5, wherein said differential pressure is less than 0.5 psi, after being compensated.

10. The pump of claim 5, wherein the control unit includes a processor coupled to a memory in which machine instructions comprising a control algorithm are stored, said machine instructions being executed by the processor and causing it to determine the differential pressure and to adjust the initial position of the plunger to compensate for the differential pressure.

11. The pump of claim 10, wherein the control algorithm uses a pressure sensed by the outlet pressure sensor, after the outlet valve has just opened and fluid is flowing through the outlet valve to the patient, to determine a calibration difference between the inlet pressure sensor and the outlet pressure sensor, and wherein said calibration difference is used by the algorithm when adjusting the initial position of the plunger to compensate for the differential pressure during a next pump cycle.

12. The pump of claim 10, wherein parameters of the control algorithm are empirically determined for a specific design of the disposable cassette and the drive unit.

13. The pump of claim 10, wherein when the control unit determines that the differential pressure between the inlet pressure sensor and the outlet pressure sensor is such that a greater pressure is indicated at the outlet pressure sensor than at the inlet pressure sensor, the control unit causes the plunger to advance toward the chamber to a position determined by the algorithm, and when the control unit determines that the differential pressure between the inlet pressure sensor and the outlet pressure sensor is such that a lower pressure is indicated at the outlet pressure sensor than at the inlet pressure sensor, the control unit causes the plunger to retract away from the chamber, to a position determined by the algorithm.

14. The pump of claim 13, wherein when the plunger is advanced from its initial position to a compensated position as determined by the algorithm, said advancement causes a greater deformation of the elastomeric membrane, and thus causes a volume of the chamber to decrease and a pressure within the chamber to increase;

and wherein when the plunger is retracted from its initial position to a compensated position as determined by the algorithm, said retraction causes a lesser deformation of the elastomeric membrane, and thus causes a volume of the chamber to increase and a pressure within the chamber to decrease.

15. The pump of claim 10, wherein the algorithm incorporates a first lookup table in which the plunger position is a function of a pressure associated with the inlet, and a second lookup table in which the plunger position is a function of a pressure associated with the outlet, and a compensated plunger position is determined by combining a result from both lookup tables.

16. The pump of claim 15, wherein the first and second lookup tables are empirically determined.

17. The pump of claim 10, wherein after the plunger has exerted a force on the elastomeric membrane and displaced the fluid from the chamber to the outlet port, the control unit uses the algorithm to determine the actual fluid volume displaced from the chamber, and to then determine a correction factor for modifying the next pump cycle to maintain a desired delivery rate of the fluid to the patient.