IP Library Granted Patent US 9,488,167
Granted Patent B2
US 9,488,167 · App. 14/290,482 · Granted Nov 8, 2016

System, method, and apparatus for utilizing a pumping cassette

Inventors: Larry B. Gray (Merrimack, NH); Robert J. Bryant, Jr. (Manchester, NH); Geoffrey P. Spencer (Manchester, NH)
Assignee: DEKA Products Limited Partnership
F04B45/06A61M1/1649A61M1/267A61M1/367A61M5/14A61M5/14224A61M5/172F04B43/02F04B43/067F04B45/00F04B45/02F04B49/065F04B49/12F04B53/10F04B53/16G01M3/26G01M3/32G05D16/20A61M5/14593A61M39/228A61M2205/12A61M2209/02
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Quick Facts
Patent No.
US 9,488,167
App. No.
14/290,482
Granted
Nov 8, 2016
Kind
B2
Abstract

The present invention involves, in some embodiments, systems and methods for performing an integrity test on a medical grade cassette that is configured to be used on a medical fluid handling system, wherein the cassette may be disposable and may comprise a membrane therein. The test may be configured to determine an error condition, such as detection of membrane leakage above a threshold value, and may in certain cases be implemented by a medical computer system. In certain cases the integrity test is a dry integrity test and in certain cases, the test is configured to determine a leakage rate of fluid through the membrane.

Claims (122)

1. A method for performing a dry integrity test on a medical-grade cassette, the medical-grade cassette being a single-use disposable cassette that can removably mate with a reusable portion of a dialysis machine, the method comprising:

adjusting a pressure of a pressure tank in the reusable portion;

closing a valve in the reusable portion of the dialysis machine connecting the pressure tank to a membrane of a medical-grade disposable cassette;

measuring a first pressure of the pressure tank within the reusable portion;

opening the valve in the reusable portion;

measuring a second pressure of the pressure tank;

determining a difference between the first and second pressures; and

determining whether the membrane of the medical-grade disposable cassette is leaking above a threshold using the difference.

2. The method according to claim 1 , wherein the method is implemented by one or more processors within a medical apparatus.

3. The method according to claim 1 , wherein the cassette is loaded into a dialysis machine, wherein the dialysis machine performs the method.

4. The method according to claim 1 , wherein the act of determining whether the membrane is leaking above the threshold using the difference comprises the act of comparing the difference to a predetermine value to determine if the difference is greater than the predetermined value.

5. The method according to claim 1 , where the acts of opening the value and closing the valve each includes an act of actuating the valve.

6. The method according to claim 1 , further comprising an act of actuating the valve to transition from the open valve position to the closed valve position.

7. The method according to claim 1 , wherein the first pressure measurement is determined by taking a first set of a plurality of measurements of a pressure transducer.

8. The method according to claim 7 , wherein the first set of the plurality of measurements occur at predetermined intervals.

9. The method according to claim 7 , wherein the second pressure measurement is determined by taking a second set of a plurality of measurements of the pressure transducer.

10. The method according to claim 9 , wherein the second set of the plurality of measurements occur at the predetermined intervals.

11. The method according to claim 1 , wherein the first and second measurements are temporally different.

12. The method according to claim 1 , further comprising the act of continuously monitoring the pressure of the pressure tank.

13. The method according to claim 1 , wherein the determining acts are calculating acts performed by at least one processor.

14. The method according to claim 1 , further comprising the act of halting an operation of a dialysis machine when the difference is above the threshold.

15. The method according to claim 1 , wherein the membrane is determined to be leaking if the difference is above the threshold.

16. A method for performing a dry integrity test on a disposable cassette that is configured to be used on a medical fluid handling system, the method comprising:

receiving a pressure on a membrane of the cassette;

measuring a first pressure associated with the membrane;

allowing a predetermined amount of time to pass;

measuring a second pressure associated with the membrane;

determining a difference between the first and second pressures; and

determining whether the difference is above a predetermined threshold.

17. The method according to claim 16 , wherein the method further comprises determining the cassette has a leak if the difference is above the predetermined threshold.

18. The method according claim 16 , wherein the method is configured to have a greater difference as a leak in the membrane is larger.

19. A method for detecting a leakage rate of fluid through a medical grade membrane in a fluid flow control system having a first chamber and a second chamber, the membrane being disposed between the first chamber and the second chamber, the second chamber having a connection to a pressure tank, the pressure tank having a fluid with a pressure, the connection defining a fluid path, the method comprising:

blocking the fluid path;

adjusting the pressure of the fluid in the pressure tank;

measuring a first pressure in the pressure tank to generate a first pressure value while the fluid path is blocked and after the pressure in the pressure tank is adjusted;

unblocking the fluid path;

measuring a second pressure in the pressure tank to generate a second pressure value after the fluid path is unblocked; and

determining whether there is a leak in the membrane based on a difference between the first pressure and the second pressure.

20. A method for detecting a leakage rate of fluid through a medical membrane in a fluid flow control medical system having a first chamber and a second chamber, the membrane being disposed between the first chamber and the second chamber, the second chamber having a medical-grade connection to a pressure tank, the pressure tank having a fluid with a pressure, the connection defining a medical-grade fluid path, the method comprising:

blocking the fluid path;

adjusting the pressure of the fluid in the pressure tank;

measuring a first pressure in the pressure tank to generate a first pressure value while the fluid path is blocked and after the pressure in the pressure tank is adjusted;

unblocking the fluid path;

measuring a second pressure in the pressure tank to generate a second pressure value after the fluid path is unblocked; and

determining a leakage of fluid through the membrane based on the first and second pressure values.

21. The method according to claim 20 , further comprising the act of causing an alarm when the leakage becomes greater than a predetermined threshold value.

22. The method according to claim 21 , wherein the step of causing an alarm occurs in a processor.

23. The method according to claim 21 , wherein the alarm is an auditory alarm.

24. The method according to claim 21 , wherein the alarm is a visual alarm.

25. The method according to claim 20 , wherein in the act of measuring a pressure at a first set of multiple timed intervals and in the act of measuring a pressure at a second set of multiple timed intervals the pressure is measured with a transducer.

26. The method according to claim 20 , wherein in the act of calculating a blocked pressure rate and in the act of calculating an unblocked pressure rate the rates are calculated in a processor.

27. The method according to claim 20 , wherein the fluid is air.

28. The method according to claim 20 , further comprising the acts of:

measuring the pressure at a first set of multiple timed intervals; and

storing each of the pressure measurements in a memory unit; and

providing the pressure measurements in the memory unit to a processor.

29. The method according to claim 20 , further comprising the acts of:

measuring the pressure at a second set of multiple timed intervals;

storing each of the pressure measurements in a memory unit; and

providing the pressure measurements in the memory unit to a processor.

30. A method implemented by a medical computer system for detecting a leakage rate of fluid through a membrane in a fluid flow control system having a first chamber and a second chamber, the membrane disposed between the first chamber and the second chamber, the second chamber having a connection to a pressure tank, the pressure tank having a fluid with a pressure, the connection defining a fluid path, the method implemented by executing a set of instructions on the medical computer, the method performing the acts of:

activating, using the medical computer, a valve controller for blocking the fluid path;

adjusting, using the medical computer, the pressure of the fluid in the pressure tank;

reading, using the medical computer, the pressure in the pressure tank while the fluid path is blocked;

creating, using the medical computer, a pressure measurement at each of a first set of multiple timed intervals while the fluid path is blocked and after the pressure is adjusted;

calculating, using the medical computer, a blocked pressure value based on the pressure measurements in the pressure tank at the first set of multiple timed intervals;

activating, using the medical computer, the valve controller unblocking the fluid path;

reading, using the medical computer, the pressure within the pressure tank while the fluid path is unblocked;

creating, using the medical computer, a pressure measurement at each of a second set of multiple timed intervals after the fluid path is unblocked;

calculating, using the medical computer, an unblocked pressure value based on the pressure measurements in the pressure tank at the second set of multiple timed intervals; and

calculating, using the medical computer, a leakage rate based on the blocked pressure value and the unblocked pressure value.

31. The method according to claim 30 , wherein the blocked pressure value and the unblocked pressure value are pressure measurements.

32. The method according to claim 30 , further comprising the act of alarming the medical computer when the leakage rate becomes greater than a predetermined threshold value.

33. The method according to claim 30 , further comprising the act of causing an alarm to be an auditory alarm.

34. The method according to claim 30 , further comprising an act of causing an alarm to be a visual alarm.

35. A method for detecting a leakage rate of fluid through a membrane in a fluid flow control system having a first chamber and a second chamber, the membrane being disposed between the first chamber and the second chamber, the second chamber having a connection to a pressure tank, the pressure tank having a fluid with a pressure, the connection defining a fluid path, the method comprising:

blocking the fluid path;

adjusting the pressure of the fluid in the pressure tank;

taking a first measurement of the pressure within the pressure tank after the pressure tank is adjusted and the fluid path is blocked;

unblocking the fluid path;

taking a second measurement of the pressure within the pressure tank after the fluid path is unblocked;

taking the difference between the first and second measurements; and

determining whether the difference is above a threshold.

36. The method according to claim 35 , wherein the second measurement occurs at a predetermined amount of time after the first measurement thereby defining a leak rate.

37. The method according to claim 35 , wherein the act of determining whether the difference is above a threshold is determining whether a leak rate is past a critical leak rate.

38. The method according to claim 35 , further comprising the act of causing an alarm when the leakage becomes greater than a predetermined threshold value.

39. The method according to claim 38 , wherein the act of causing an alarm occurs in a processor.

40. The method according to claim 38 , wherein the alarm is an auditory alarm.

41. The method according to claim 38 , wherein the alarm is a visual alarm.

42. The method according to claim 35 , wherein in the acts of taking a first measurement of the pressure includes an act of measuring a pressure at a first set of multiple timed intervals and, the act of taking a second measurement includes the act of measuring a pressure at a second set of multiple timed intervals the pressure.

43. The method according to claim 42 , wherein the act of taking the first and second measurements utilizes a pressure transducer.

44. The method according to claim 35 , wherein in the act of taking a first measurement and in the act of taking a second measurement are at least partially implemented by a calculation of a processor.

45. The method according to claim 35 , wherein the fluid is air.

46. The method according to claim 35 , further comprising the act of:

taking the first measurement using a first set of multiple timed intervals; and

storing each of the pressure measurements in a memory unit; and

providing the pressure measurements in the memory unit to a processor.

47. The method according to claim 35 , further comprising the act of taking the second measurement using a second set of multiple timed intervals;

storing each of the pressure measurements in a memory unit;

providing the pressure multiplied timed interval measurements to the processor; and

calculating, by the processor, the first and second measurements.

48. A method for performing a dry integrity test on a medical-grade cassette, the method comprising:

adjusting a pressure of a pressure tank;

adjusting a valve connecting the pressure tank to a membrane of a cassette to a first position;

measuring a first pressure of the pressure tank after the valve has been in the first position;

adjusting the valve to a second position;

measuring a second pressure of the pressure tank after the valve has been in the second position;

determining a difference between the first and second pressures; and

determining whether the membrane is leaking above a threshold using the difference.

49. The method according to claim 48 , wherein the method is implemented by one or more processors within a medical apparatus.

50. The method according to claim 48 , wherein the cassette is loaded into a dialysis machine, wherein the dialysis machine performs the method.

51. The method according to claim 48 , wherein the act of measuring the first pressure occurs while the valve still remains in the first position.

52. The method according to claim 48 , wherein the act of measuring the second pressure occurs while the valve still remains in the second position.

53. A method for performing a dry integrity test on a medical-grade cassette, the method comprising:

adjusting a pressure of a pressure tank;

adjusting a valve connecting the pressure tank to a membrane of a cassette to a first position;

measuring a first pressure of the pressure tank after the valve has been in the first position;

adjusting the valve to a second position;

measuring a second pressure of the pressure tank after the valve has been in the second position;

determining a difference between the first and second pressures; and

determining whether there is a leak in the membrane based on the difference between the first and second pressures.

54. The method according to claim 53 , wherein the determination of whether there is a leak in the membrane includes the act of determining whether the difference is beyond a threshold.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 10, 2014
From: GRAY, LARRY B.; BRYANT, ROBERT J., JR.; SPENCER, GEOFFREY P.
To: DEKA PRODUCTS LIMITED PARTNERSHIP
Reel/Frame 033065/0960 →
Continuity (6)
Continuation 13973630 · Aug 22, 2013
Continuation 12847980 · Jul 30, 2010
Division 12423665 · Apr 14, 2009
Continuation 10951441 · Sep 28, 2004
Continuation 09357645 · Jul 20, 1999
Related Publication 20140260551A1 · Sep 18, 2014