Apparatus and method to test for valve leakage in a pump assembly

• US 5,000,664 A
• Filed: 06/07/1989
• Issued: 03/19/1991
• Est. Priority Date: 06/07/1989
• Status: Expired due to Term

• Current Assignee: Hospira Incorporated (Pfizer Inc.)
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Yung, Anthony C., Lawless, Michael W., Pastrone, Giovanni, Jimison, Walter L.
• Primary Examiner(s): Fox, John C.
• Application Number:
  US07/362,888
• Time in Patent Office: 650 Days
• Field of Search: 417/9, 417/63, 417/479, 73/40, 73/46, 73/168
• US Class Current: 417/63
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066

Abstract

Apparatus and method for determining leakage, particularly of valves, in a pumping cassette. A cassette (70) includes a primary valve (34) and a secondary valve (36), which may be selectively activated to control the source of fluid input to the cassette. The cassette also includes an inlet valve (48) and an outlet valve (56) disposed on each side of a pumping chamber (52). Downstream of the outlet valve is disposed a pressure sensor (60) which produces a signal indicative of the pressure of fluid within the cassette at that point. The cassette also includes an air-in-line sensor (40), disposed between a manifold line (38) that connects the primary and secondary valve in fluid communication with an air trap reservoir (44). Leakage in the inlet or outlet valves is detected by closing both valves, pressurizing fluid in the pumping chamber for a predetermined period of time, and then opening the outlet valve. If a pressure pulse having an amplitude less than a predetermined level is detected downstream of the outlet valve when it is opened, either the inlet or outlet valve has leaked. The primary and secondary valves are checked for leakage either by pressurizing fluid in the pumping chamber and checking for retrograde flow of air trapped in the air trap reservoir through the air-in-line sensor, or by pressurizing fluid trapped in the cassette, holding the pressure for a period of time before closing the inlet valve, and then opening the outlet valve to detect a pressure pulse propagating downstream of the outlet valve, using the pressure sensor. If a pressure pulse of less than the predetermined magnitude is detected, one of the primary or secondary outlet valves is leaking. Both tests also detect leakage of other portions of the pumping cassette.

Claims

1. A pump assembly having the capacity to self test for leakage, comprising:

(a) a pumping chamber in which a fluid is pressurized during a pumping cycle;

(b) an inlet valve that periodically interrupts fluid flow into and out of the pumping chamber, with respect to a source of the fluid disposed upstream of the inlet valve;

(c) an outlet valve that periodically interrupts fluid flow into and out of the pumping chamber, with respect to a delivery passage through which pressurized fluid flows when the pump assembly is operating to pump the fluid;

(d) a pressure sensor, disposed downstream of the outlet valve and operative to sense the pressure of the fluid and to produce a signal indicative of that pressure; and

(e) control means for controlling the pumping cycle, including self test means connected to receive the signal produced by the pressure sensor for;

(i) filling the pumping chamber with the fluid;

(ii) closing the inlet and the outlet valves;

(iii) effecting at least a partial pumping cycle to pressurize fluid in the pumping chamber and thereafter terminating the pumping cycle;

(iv) after a predetermined time interval during which the pump assembly is inactive to further pressurize fluid in the pumping chamber, opening the outlet valve; and

(v) determining whether the pump assembly has leaked during the predetermined time interval, as a function of the signal produced by the pressure sensor after the outlet valve is opened.

2. The pump assembly of claim 1, wherein said signal produced by the pressure sensor is indicative of a pressure pulse caused by propagation of a pressurized fluid wave down the delivery passage from the pressure chamber when the outlet valve is opened.

3. The pump assembly of claim 2, wherein unacceptable leakage from a volume of fluid nominally trapped between the inlet and outlet valves during the predetermined time interval is detected by the self test means if the maximum magnitude of the pressure pulse is less than a predetermined value.

4. The pump assembly of claim 1, wherein the control means are further operative to effect an alarm if the self test means determine that the pump assembly has leaked during the predetermined time interval.

5. The pump assembly of claim 4, wherein the self test means are operative to repetitively test for fluid leakage, and to determine that the pump assembly is leaking only if a predetermined number of such tests indicate leakage.

6. The pump assembly of claim 1, further comprising selector valve means, disposed upstream of the inlet valve and connected in fluid communication therewith by an inlet passage, for selecting at least one inlet port from among a plurality of inlet ports on the pump assembly for connection to the source supplying the fluid to the inlet valve and pumping chamber.

7. The pump assembly of claim 6, wherein the self test means are further operative to detect leakage by:

(a) filling the inlet passage and pumping chamber with fluid;

(b) closing the selector valve means and the outlet valve;

(c) effecting at least a partial pumping cycle to pressurize fluid in the inlet passage and in the pumping chamber;

(d) after a second predetermined time interval, closing the inlet valve and then opening the outlet valve; and

(e) determining whether the pump assembly has leaked during the second predetermined time interval, as a function of the signal produced by the pressure sensor after the outlet valve is opened.

8. The pump assembly of claim 7, wherein said signal produced by the pressure sensor is indicative of a pressure pulse caused by propagation of a pressurized fluid wave down the delivery passage chamber when the outlet valve is opened.

9. The pump assembly of claim 8, wherein unacceptable leakage from a volume of fluid nominally trapped between the selector valve means and the inlet valve during the second predetermined time interval is detected by the self test means if the maximum magnitude of the pressure pulse is less than a predetermined value.

10. The pump assembly of claim 6, further comprising an air trap reservoir disposed on the inlet passage, and an air-in-line sensor disposed in the inlet passage between the air trap reservoir and the selector valve means, said air-in-line sensor being operative to produce a signal indicative of the presence of air in the inlet passage where said air-in-line sensor is disposed and being connected to provide that signal to the self-test means.

11. The pump assembly of claim 10, wherein the self test means are further operative to alternatively determine whether unacceptable leakage form a volume of fluid nominally trapped between the selector valve means and the outlet valve has occurred, if air is trapped in the air reservoir, by:

(a) filling the inlet passage and pumping chamber with a liquid;

(b) closing the selector valve means and the outlet valve;

(c) effecting at least a partial pumping cycle to pressurize the liquid in the pumping chamber and in the inlet passage; and

(d) determining whether the selector valve means are leaking as a function of the signal produced by the air-in-line sensor.

12. The pump assembly of claim 11, wherein a change in the signal produced by the air-in-line sensor indicating the presence of air flowing from the air trap reservoir into the inlet passage where the air-in-line sensor is located, after said at least partial pumping cycle is initiated is determinative of a leak in the pump assembly.

13. The pump assembly of claim 11, wherein the self test means are further operative to effect a plurality of pumping cycles before closing the selector valve means and the outlet valve, in order to clear any air initially present in the inlet passage where the air-in-line sensor is disposed.

14. The pump assembly of claim 11, wherein the self test means are operative to determine whether the pump assembly is leaking as a function of the signal produced by the air-in-line sensor only if the air trap reservoir initially contains a substantially quantify of air, part of which is forced into the air-in-line sensor if fluid leaks from the pump assembly upstream of the air-in-line sensor when the liquid in the inlet passage is pressurized.

15. In a pump assembly having a plurality of valves, including an inlet valve and an outlet valve, a pumping chamber disposed between the inlet valve and outlet valve, and a control that selectively opens and closes the inlet and outlet valves and activates a driver to pressurize a fluid within the pumping chamber in a pump cycle, apparatus to test for leakage of the pump assembly, comprising:

pressure sensing means for producing a signal indicative of the pressure of fluid in a fluid passage downstream of the outlet valve; and

leak detection means, connected to receive the signal produced by the pressure sensing means, for detecting leakage from the pump assembly as a function of the signal produced by the pressure sensing means immediately after the outlet valve is opened, said outlet valve being opened after fluid within the pumping chamber has been pressurized for an interval of time drain which the driver is inactive to further pressurize fluid in the pumping chamber.

16. The apparatus of claim 15, wherein leakage is detected by the leak detection means if the signal produced by the pressure sensing means indicates that a peak pressure of a pulse propagating through the fluid passage when the outlet valve is opened is less than a predetermined value.

17. The apparatus of claim 15, further comprising means for effecting an alarm when leakage is detected.

18. The apparatus of claim 15, wherein the plurality of valves further include selector valve means for selecting from among a plurality of inlets to the pump assembly a source of fluid for input to the pumping chamber as determined by the control means, said selector valve means being connected in fluid communication with the inlet valve by an inlet passage.

19. The apparatus of claim 18, further comprising an air trap reservoir and air-in-line sensor means, both disposed in the inlet passage, for detecting the presence of air/liquid upstream of the air trap reservoir and producing a signal indicating whether air or liquid is present in the inlet passage at the air-in-line sensor means, wherein the leak detection means are alternatively operative to detect leakage through the selector valve means as a function of the signal produced by the air-in-line sensor means when both the selector valve means and the outlet valve are closed if substantial air is initially present in the air trap reservoir, and if not, to detect leakage through the selector valve means as a function of the signal produced by the pressure sensor means when the outlet valve is opened, releasing pressurized liquid from the pumping chamber, said liquid having been initially trapped between the selector valve means and the outlet valve when initially pressurized.

20. The apparatus of claim 19, wherein the leak detection means determines that the selector valve means are leaking as a function of the signal produced by the air-in-line sensor means if, during pressurization of liquid in the pumping chamber, said air-in-line sensor means begin to indicate the presence of air rather than liquid.

21. In a pump assembly including an inlet valve, an outlet valve, a chamber in which fluid is pressurized during a pump cycle, a pressure sensor disposed downstream of the outlet valve, and a control for selectively initiating the pump cycle, a method for testing the leak proof integrity of the pump assembly, comprising the steps of:

(a) filling the chamber with the fluid;

(b) closing the inlet and the outlet valves;

(c) effecting at least a partial pumping cycle to pressurize fluid in the chamber and then terminating the pumping cycle;

(d) after a predetermined time interval during which the pump assembly is inactive to further pressurize fluid in the chamber, opening the outlet valve; and

(e) monitoring a fluid pressure downstream of the outlet valve, after it is opened and

(f) determining whether the pump assembly has leaked during the predetermined time interval, as a function of said pressure.

22. The method of claim 21, wherein the step of monitoring includes the step of detecting a pressure pulse propagating downstream of the outlet valve after it is opened, and wherein the step of determining whether the pump assembly has leaked includes the step of determining whether a peak of the pressure pulse exceeds a predetermined minimum value, leakage of the fluid from a volume of fluid nominally trapped between the inlet and outlet valved causing the peak to be less than said predetermined value.

23. The method of claim 21, further comprising the step of effecting an alarm if a leak is detected.

24. The method of claim 21, further comprising the step of repeating steps through a plurality of times, wherein step f comprises the step of determining whether the pump assembly is leaking as a function of the pressure in a plurality of such repetitions.

25. A method for testing leakage integrity in a pump cassette including a plurality of valves, comprising the steps of:

(a) filling the pump cassette with a liquid;

(b) closing at least two valves on the pump cassette to define a nominal sealed volume in which liquid is trapped between said valves;

(c) effecting operation of the pump to pressurize the liquid trapped in the nominal sealed volume and thereafter stopping the pump to test for leakage;

(d) waiting an interval of time during which the pump is not operating to further pressurize the liquid trapped in the nominal sealed volume;

(e) opening one of the valves; and

(f) detecting that leakage has occurred from the nominal sealed volume defined by the closed valves, as a function of a pressure downstream of said one of the valves after it is opened.

26. The method of claim 25, wherein the step of detecting leakage comprises the step of determining that a pressure pulse of less than a predetermined magnitude propagates downstream of said one valve when it is opened.

27. The method of claim 26, further comprising the step of closing another of the valves after waiting the interval of time and before opening said one valve, to define a smaller volume of trapped liquid.