Blood tubing set integrity tests for extracorporeal circuits

• US 6,044,691 A
• Filed: 08/26/1998
• Issued: 04/04/2000
• Est. Priority Date: 08/26/1998
• Status: Expired due to Term

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Aksys Ltd.
• Inventors: Treu, Dennis M., Kenley, Rodney S., Kapadia, Seema A., Feldsien, Thomas M., Peter, Frederick H. Jr., Duch, Michael, Schroeder, Christine F.
• Primary Examiner(s): Williams, Hezron
• Assistant Examiner(s): Cygan, Michael
• Application Number:
  US09/140,483
• Time in Patent Office: 587 Days
• Field of Search: 73/40.5 R, 73/40, 210/646, 210/741
• US Class Current: 73/40.50R
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1684 Checking the module characteristics before reuse
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards

Abstract

Several tests are described for verifying the integrity of the extracorporeal circuit of a medical instrument, such as a dialysis machine. One test verifies the condition of the blood tubing set. Another test verifies that the clamps in the arterial and venous lines adequately occlude the arterial and venous lines. Another test confirms that the arterial and venous lines are properly installed on their respective ports for receiving the lines after the treatment session has ended. In this last test, a fluid such as heated water is then introduced into one of the arterial or venous lines and sent out of the line through its respective port, where it is detected with suitable fluid detection equipment such as a thermistor. The heated fluid and thermistor verify that the arterial line is connected to its arterial port and the venous line is connected to its venous port and that there is an unobstructed fluid path in the blood tubing set. If the lines are installed on the wrong port, the user is prompted to correctly install the arterial and venous lines on their respective ports.

Claims

1. A method for testing the integrity of a blood tubing set for an extracorporeal circuit, said blood tubing set comprising an arterial line with an arterial clamp and a venous line with a venous clamp, the method performed in situ in a machine containing said blood tubing set and having arterial and venous manifold ports for receiving said arterial and venous lines, said ports connected to hydraulic circuitry in said machine by one or more valves,

the method comprising the steps of:

a) connecting said arterial and venous lines to said arterial and venous manifold ports;

b) evacuating fluid which may be present in said blood tubing set, comprising the steps of opening said arterial and venous clamps and introducing air into said arterial and venous lines to push said fluid out of said extracorporeal circuit;

c) isolating said blood tubing set from said hydraulic circuitry in said machine by closing said one or more valves;

d) forcing air into said blood tubing set so as to raise the pressure in said blood tubing set substantially above ambient atmospheric pressure;

e) measuring the pressure in said blood tubing set with a pressure sensor; and

f) measuring the pressure decay in said blood tubing set by making a second pressure measurement after a dwell period, the magnitude of said pressure decay indicative of the condition of said blood tubing set; and

wherein said arterial and venous manifold ports receiving said arterial and venous lines are in fluid communication with a dialysate preparation system and wherein said one or more valves, when closed, isolate said ports from said dialysate preparation system.

2. The method of claim 1, wherein said extracorporeal circuit is incorporated in a machine for treating a patient suffering from inadequate kidney or liver function.

3. The method of claim 1, wherein said dwell period comprises between about 20 and about 30 seconds.

4. The method of claim 2, where said machine further comprises a dialyzer and a computer control system controlling the pressurization of said blood tubing set, and wherein said computer control system operates an air pump connected to said blood tubing set so as to pressurize said blood tubing set to a predetermined value associated with a particular commercial source of said dialyzer.

12. The method of claim 1, further comprising the additional steps after step f) of repressurizing said blood tubing set to a predetermined value, waiting a second dwell period, and measuring the pressure decay of said blood tubing set a second time, and subsequently prompting a user of said machine to replace said blood tubing set or extracorporeal circuit in the event that said pressure decay again exceeds a predetermined threshold.

5. A method for testing the integrity of an arterial line clamp and a venous line clamp of a machine having a blood tubing set, said blood tubing set comprising an arterial line threaded through said arterial line clamp, a venous line threaded through said venous line clamp, and a vent line incorporating an air pump capable of forcing air into or removing air from a first portion of said blood tubing set extending between said arterial line clamp and said venous line clamp;

the method performed in situ in a machine containing said blood tubing set, the machine comprising arterial and venous manifold ports for receiving said arterial and venous lines, said ports connected to hydraulic circuitry in said machine by one or more valves,

the method comprising the steps of;

a) closing said arterial and venous clamps;

b) pressurizing said first portion of said blood tubing set between said arterial clamp and said venous clamp to a pressure substantially above atmospheric pressure;

c) venting a portion of said arterial line between said arterial clamp and said arterial manifold port to ambient pressure;

d) venting a portion of said venous line between said venous clamp and said venous manifold port to atmospheric pressure;

e) measuring the pressure in said first portion of said blood tubing set after said step of venting; and

f) determining from said measurements of pressure the condition of said arterial and venous clamps.

6. The method of claim 5, wherein said machine comprises a machine for treating a patient suffering from inadequate kidney or liver function.

7. The method of claim 5, wherein said step of measuring pressure comprises the step of measuring a level at which the pressure in said first portion of said blood tubing set stabilizes after said step of venting has been completed, wherein said clamps are deemed to have failed if said level is lower than a predetermined threshold level.

8. The method of claim 5, wherein said step of measuring pressure comprises the step of measuring the pressure decay in said first portion of the extracorporeal circuit for a predetermined dwell period.

9. The method of claim 6, where said machine further comprises a dialyzer and a computer control system controlling the pressurization of said blood tubing set, and wherein said computer control system operates an air pump in communication with said blood tubing set to pressurize said blood tubing set to a predetermined value associated with a particular commercial source of said dialyzer.

10. The method of claim 6, wherein said arterial line is vented to atmosphere via an ultrafiltration tank within said machine and wherein said venous line is vented to atmosphere via a dialysate tank within said machine, said ultrafiltration tank and dialysate tanks in fluid communication with said arterial and venous lines via first and second valves and said arterial and venous manifold ports.

11. The method of claim 5, wherein said blood pump is an occlusive pump and said measurements of pressure and pressure decay are taken by first and second pressure sensors located on either side of said blood pump.

13. The method of claim 5, further comprising the step of prompting the user of said machine to initiate a service call for said machine in the event that said measurements of pressure indicate that said arterial and venous lamps are not operating properly.

14. The method of claim 5, wherein said machine is connected via a communication line to a service agency or manufacturer for said machine, and the method further comprising the step of automatically initiating a service call for said machine via said communications line in the event that said pressure decay exceeds a predetermined threshold limit.

15. In a medical instrument having an extracorporeal blood circuit comprising an arterial line with an arterial clamp and a venous line with a venous clamp, said machine having arterial and venous manifold ports for receiving said arterial and venous lines after a treatment session, said ports connected to hydraulic circuitry in said machine by one or more valves,

a method for verifying the proper connection of said arterial and venous lines to said arterial and venous manifold ports, comprising the steps of:

closing said one or more valves to isolate said arterial and venous lines from said hydraulic circuitry;

removing air from said arterial and venous lines and detecting a reduction in pressure with a pressure sensor in said extracorporeal circuit, said reduction in pressure indicating that said arterial and venous lines were installed on said arterial and venous ports and said arterial and venous clamps are in an off condition; and

pumping air into said arterial and venous lines to pressurize said blood tubing set to a predetermined value and measuring the pressure decay of said blood tubing set, the absence of a substantial pressure decay indicative that said arterial and venous lines have been securely received by said arterial and venous manifold ports.

16. The method of claim 15, further comprising the step of introducing a fluid into one of said arterial and venous lines and detecting the presence or absence of said fluid with a fluid detection means downstream of one of said arterial or venous ports normally associated with the line that said fluid is introduced into.

17. The method of claim 16, wherein said fluid comprises water.

18. The method of claim 16, wherein said fluid detection means comprises a thermistor.

19. The method of claim 18, wherein said fluid comprises a heated fluid.

20. The method of claim 15, wherein said machine further comprises a first fluid detection means downstream of said arterial port and a second fluid detection means downstream of said venous port, and wherein the method further comprises the steps of introducing a fluid into one of said arterial and venous lines of said blood tubing set and directing said fluid out of the port that said one of said arterial and venous lines is connected to, and detecting said fluid with one of said first or second fluid detection means, wherein the detection of said fluid by the fluid detection means downstream of the other of said arterial or venous manifold ports for a line that did not receive said fluid indicates that said arterial and venous lines are incorrectly installed on said arterial and venous manifold ports.

21. The method of claim 16, wherein said machine comprises a dialysis machine and wherein said extracorporeal circuit further comprises a dialyzer connected to said arterial and venous lines and having a dialysate side and a blood side, and wherein said step of introducing a fluid comprises the step of backflushing said fluid from said dialysate side into said blood side of said dialyzer into one of said arterial or venous lines.

22. In a medical instrument having an extracorporeal blood circuit comprising an arterial line and a venous line, said machine having arterial and venous manifold ports for receiving said arterial and venous lines after a treatment session, said machine further comprising a fluid detection means downstream of at least one of said arterial port and said venous port,

a method for verifying the proper connection of said arterial and venous lines to said arterial and venous manifold ports, comprising the steps of:

introducing a fluid into one of said arterial and venous lines of said blood tubing set and directing said fluid out of the arterial or venous manifold port that said one of said arterial and venous lines is connected to, and

detecting the presence or absence of said fluid with said fluid detection means.

23. The method of claim 22, wherein said machine comprises a dialysis machine and wherein said extracorporeal circuit further comprises a dialyzer connected to said arterial and venous lines and having a dialysate side and a blood side, and wherein said step of introducing said fluid comprises the step of backflushing said fluid from said dialysate side into said blood side of said dialyzer into one of said arterial or venous lines.

24. The method of claim 23, wherein said machine further comprises occlusive blood pump in said arterial line and wherein said fluid is backflushed into said venous line, and wherein said fluid detection means is positioned downstream of said venous manifold port.

25. The method of claim 22, wherein said fluid is selected from the group of fluids consisting of water, dialysate solution, cleaning solution and saline solution.

26. The method of claim 22, wherein said fluid detection means is selected from the group of detectors consisting of conductivity sensors, pressure sensors, thermistors, capacitative sensors, ultrasonic detectors and optical detectors.

27. The method of claim 22, wherein said fluid detection means is positioned downstream of said venous manifold port and wherein a second fluid detection means is incorporated into said instrument downstream of said arterial manifold port.

28. A method of testing the integrity of a clamp for closing off a blood line of an extracorporeal circuit, said blood line having a first portion upstream of said clamp and a second portion downstream of said clamp terminating in a free end adapted to be connected to a patient, comprising the steps of:

placing said clamp in a closed condition,

pressurizing said first portion of said blood line to a pressure substantially above the pressure of said second portion of said blood line;

measuring the pressure within said first portion of said blood line with a pressure sensor; and

determining from said measuring of pressure the condition of said clamp.

29. The method of claim 28, wherein said step of measuring the pressure comprises the step of measuring a level at which the pressure in said first portion of said blood line stabilizes, wherein said clamp is deemed to have failed if said level is lower than a predetermined threshold level.

30. The method of claim 29, wherein said step of measuring pressure comprises the step of measuring the pressure decay in said first portion of said blood line for a predetermined dwell period.

31. The method of claim 28, wherein said extracorporeal circuit comprises arterial and venous lines and wherein said arterial and venous lines are closed by arterial and venous clamps, and wherein said first portion of said extracorporeal circuit comprises the portion of said extracorporeal circuit between said arterial and venous line clamps, whereby the integrity of both said arterial and venous clamps are tested when said first portion of said extracorporeal circuit is pressurized.

32. In a machine having an extracorporeal circuit comprising an occlusive blood pump and arterial and venous lines terminating in arterial and venous line connectors, said arterial and venous line connectors received in a disinfection manifold port comprising arterial and venous ports for receiving said arterial and venous line connectors, respectively, said arterial and venous ports connected to a hydraulic system via first and second valves normally associated with said arterial and venous ports and arterial and venous lines, respectively,

a method of determining whether said arterial and venous lines are correctly installed on said arterial and venous ports and not vice versa, comprising the steps of:

installing said arterial and venous lines on said disinfection manifold ports;

isolating said arterial and venous lines from said hydraulic system connected to arterial and venous manifold ports by closing said first and second valves linking said arterial and venous manifold ports to said hydraulic system;

creating a pressure differential between said arterial and venous lines and said hydraulic system;

opening one of said first and second valves to thereby bring said hydraulic system and the arterial or venous line connected to the port associated with said first or second valve into equilibrium; and

detecting a change in pressure in either said first arterial line or said venous line;

whereby the detection of a change in pressure in the line associated with the valve that is opened indicates that the arterial and venous lines are correctly installed on said arterial and venous manifold ports.

33. The method of claim 32, wherein said step of creating a pressure differential comprises the step of pressurizing said venous line to a superatmospheric pressure with an air pump connected to a venous drip chamber installed in said venous line of said extracorporeal circuit.

34. The method of claim 32, wherein said hydraulic system is maintained at atmospheric pressure during said step of creating a pressure differential.