System, method, and apparatus for utilizing a pumping cassette

• US 9,593,678 B2
• Filed: 05/29/2014
• Issued: 03/14/2017
• Est. Priority Date: 07/20/1999
• Status: Expired due to Fees

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Gray, Larry B., Bryant, Robert J. Jr., Spencer, Geoffrey P.
• Primary Examiner(s): Schneider, Craig
• Assistant Examiner(s): Rost, Andrew J
• Application Number:
  US14/290,464
• Publication Number:
  US 20140276428A1
• Time in Patent Office: 1,020 Days
• Field of Search: 251/61.1, 251/128, 417/477.2, 417/477.1, 417/395, 417/394, 417/392, 417/476, 417/474, 277/646, 604/153
• US Class Current: 1/1
• CPC Class Codes: A61M 1/1649 with pulsatile dialysis fluid flow
• CPC Class Codes: A61M 1/267 used for pumping
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362261 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/362264 the filter being a blood filter
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2209/02 Equipment for testing the apparatus
• CPC Class Codes: A61M 39/228 with a tubular diaphragm constrictable by radial fluid force
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: F04B 43/067 the fluid being actuated directly by a piston
• CPC Class Codes: F04B 45/00 Pumps or pumping installations having flexible working members and specially adapted for elastic fluids
• CPC Class Codes: F04B 45/02 having bellows
• CPC Class Codes: F04B 49/065 and making use of computers
• CPC Class Codes: F04B 49/12 : by varying the length of stroke of the working members
• CPC Class Codes: F04B 53/10 : Valves; Arrangement of valves
• CPC Class Codes: F04B 53/16 : Casings; Cylinders; Cylinder liners or heads; Fluid connections
• CPC Class Codes: G01M 3/26 : by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors
• CPC Class Codes: G01M 3/32 : for containers, e.g. radiators
• CPC Class Codes: G05D 16/20 : characterised by the use of electric means

Abstract

The present invention involves, in some embodiments, systems and methods for pumping fluid into or out of a patient via a cartridge. The cartridge may include a membrane defining a chamber and mechanisms to supply, measure and control pressure in the chamber. The system further includes a processor that can be configured to compare certain pressure measurements to each other to facilitate determining if an error condition exists in the medical system if the difference between measurements is greater than a threshold. In certain cases the error condition may indicate leakage of the membrane, for example due to a pinhole in the membrane.

Claims

1. A medical system for pumping fluid into or out of a patient via a cartridge coupled to a pump drive system, the medical system comprising:

a membrane of the cartridge defining a chamber of the pump drive system when the cartridge is coupled to the pump drive system;

a pressure source in fluid communication with the chamber, wherein the pump drive system is configured to adjust a pressure of the pressure source;

a pressure transducer configured to measure a pressure associated with the pressure-source;

a valve configured to isolate the chamber or operatively connect the pressure source to the chamber; and

a processor configured to perform a dry cartridge integrity test before filling the cartridge with fluid comprising;

adjusting the pressure of the pressure source to a predetermined value with one or more flowpaths of the cartridge open to the surroundings;

connecting the pressure source to the chamber;

measuring a first pressure value of the pressure transducer;

measuring a second pressure value of the pressure transducer after a predetermined amount of time;

determining a difference by comparing the first and second pressure values to each other; and

determining that an error condition exists in the medical system if the difference is greater than a threshold value.

2. The system according to claim 1, wherein the error condition indicates a leaky membrane.

3. The system according to claim 1, wherein the first pressure value is determined by taking a first set of measurements using the pressure transducer.

4. The system according to claim 3, wherein the second pressure value is determined by taking a second set of measurements using the pressure transducer.

5. The system according to claim 1, wherein the error condition indicates that the membrane is unacceptably leaky.

6. The system according to claim 1, wherein the pressure source is a pressure tank.

7. The system according to claim 1, wherein the processor is configured to actuate the valve between a first and second position to thereby isolate the chamber or operatively connect the pressure source to the chamber.

8. The system according to claim 7, wherein the first pressure value is measured with the valve in the first position thereby fluidly coupling the pressure source to the chamber.

9. The system according to claim 7, wherein the second pressure value is measured with the valve in the second position thereby isolating the pressure source from the chamber.

10. The system according to claim 1, wherein the error condition indicates a pin-hole in the membrane.

11. The system according to claim 1, wherein the error condition indicates an air leak in the membrane.

12. The system according to claim 1, wherein the predetermined value is a predetermined positive pressure value.

13. The system according to claim 1, wherein the predetermined value is a predetermined negative pressure value.

14. A medical system for pumping fluid into and out of a patient using a cartridge in operative association with a pump drive system, the medical system comprising:

a membrane defining a chamber of the pump drive system;

a pressure source in fluid communication with the chamber, wherein the pump drive system is configured to adjust a pressure within the pressure source,

a pressure transducer in operative communication with the pressure source and configured to measure a pressure of the pressure source;

a valve configured to isolate the chamber or operatively connect the pressure source to the chamber; and

a medical system processor configured to perform a dry cartridge integrity test before filling the cartridge with fluid comprising;

adjusting the pressure of the pressure source to a predetermined value;

measuring a first pressure value of the pressure transducer;

measuring a second pressure value of the pressure transducer after a predetermined amount of time;

determining a difference by comparing the first and second values to each other; and

determining whether there is leakage of the membrane based on the difference between the first and second values.

15. The system according to claim 14, wherein the processor is further configured to open one or more flowpaths of the cartridge to the surroundings prior to adjusting the pressure of the pressure source to the predetermined value.

16. A medical system for pumping fluid into or out of a patient using a cartridge, the medical system comprising:

a pump drive system configured to provide pressure to a non-porous membrane of the cartridge;

the membrane of the cartridge and a region of the pump drive system defining a chamber;

a pressure source in fluid communication with the chamber, wherein the pump drive system is configured to adjust a pressure associated with the pressure source;

a pressure transducer in operative communication with the pressure source and configured to measure the pressure associated with the pressure source;

a valve configured to isolate the chamber or operatively connect the pressure source to the chamber; and

a processor configured to perform a dry cartridge integrity test before filling the cartridge with fluid comprising;

adjusting the pressure source to a predetermined value with one or more flowpaths of the cartridge open to the surroundings;

controlling the valve to connect the pressure source to the chamber;

measuring a first pressure value of the pressure transducer;

measuring a second pressure value of the pressure transducer after a predetermined amount of time;

determining a difference by comparing the first and second values to each other; and

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

17. A medical fluid flow control system comprising:

a first chamber for pumping a liquid;

a second chamber for delivering positive or negative pressure to the first chamber;

a pressure tank containing a fluid having a pressure connected to the second chamber;

a transducer disposed within the pressure tank for creating a pressure signal;

a valve disposed between the second chamber and the pressure tank;

a medical-grade membrane disposed between the first chamber and the second chamber;

a valve controller connected to the valve;

a pump connected to the pressure tank; and

a processor connected to the transducer, to the pump and to the valve controller for performing a dry integrity test before filling the first chamber with fluid and after opening the first chamber to the surroundings, comprising;

a) signaling the valve controller to shut the valve;

b) adjusting the pressure of the fluid in the pressure tank with the pump;

c) reading the pressure signal from the transducer at a first set of predetermined intervals while the valve is shut creating a first set of pressure signal readings;

d) calculating a baseline value based on the first set of pressure signals while the valve is shut;

e) sending a signal to the valve controller to open the valve before the liquid is allowed to enter the first chamber;

f) reading the pressure signal from the transducer at a second set of predetermined timed intervals creating a second set of pressure signal readings while the valve is open;

g) calculating a second value based on the second set of pressure signals;

h) calculating a leakage rate based on the first and second value; and

i) triggering an alarm signal if the leakage rate exceeds a predefined value.

18. The system according to claim 17, wherein the alarm signal causes an auditory alarm.

19. The system according to claim 17, wherein the alarm signal causes a visual alarm.

20. The system according to claim 17, wherein the fluid is air.

21. The system according to claim 17, further comprising a memory unit for storing the pressure signals at the first set of predetermined timed intervals and storing the pressure signals at the second set of predetermined timed intervals.

22. The system according to claim 17, wherein the first chamber is disposed within a cassette wherein the membrane forms an exterior surface of the cassette.

23. A medical system for pumping fluid into or out of a patient via a cassette, the medical system comprising:

a cassette holder configured to receive a cassette

a cassette received in the cassette holder, the cassette having a membrane capable of receiving a pressure from a chamber of a pump drive system;

a pressure source in fluid communication with the chamber, wherein the pump drive system is configured to adjust a pressure of the pressure source;

a pressure transducer in operative communication with the pressure source and configured to measure a pressure of the pressure source;

a valve configured to isolate the chamber or operatively connect the pressure source to the chamber; and

a processor within the medical system configured to perform a dry integrity test before filling the cassette with fluid comprising;

adjusting the pressure source to a predetermined value with one or more flowpaths of the cassette open to the surroundings;

measuring a first pressure value of the pressure transducer;

closing the valve to isolate the chamber before the cassette is filled with liquid;

measuring a second pressure value of the pressure transducer after a predetermined amount of time;

detecting a leak of the membrane based on the first and second pressure values.

24. The system according to claim 23, wherein the detection includes using the processor to determine a difference between the first and second values.

25. The system according to claim 24, wherein the detection of the membrane leak is established if the difference is greater than a threshold.

26. A medical system for pumping fluid into or out of a patient via a cassette, the medical system comprising:

a cassette holder configured to receive a cassette

a cassette received in the cassette holder, the cassette having a membrane capable of receiving a pressure from a pump drive system;

a pressure source in valved fluid communication with the chamber, wherein the pump drive system is configured to adjust a pressure of the pressure source;

a pressure transducer in operative communication with the pressure source and configured to measure a pressure of the pressure source;

a valve configured to isolate the chamber or operatively connect the pressure source to the chamber; and

a processor within the medical system configured to perform a dry integrity test before filling the cassette with fluid comprising;

opening flowpaths of the cassette to the surroundings;

actuating the value to first or second positions;

adjusting the pressure source to a predetermined value;

measuring a first pressure value of the pressure transducer; and

measuring a second pressure value of the pressure transducer after a predetermined amount of time,

wherein the processor, the valve, the pressure source, and the pressure transducer are configured to detect a leak of the membrane.

27. The system according to claim 26, wherein the processor measures the first pressure value with the valve in the first position.

28. The system according to claim 27, wherein the processor measures the second pressure value with the valve in the second position.