Method and apparatus for occlusion monitoring using pressure waveform analysis

• US 5,906,589 A
• Filed: 11/13/1996
• Issued: 05/25/1999
• Est. Priority Date: 11/13/1996
• Status: Expired due to Fees

• Current Assignee: Caridianbct Biotechnologies LLC (Baxter International Inc.)
• Original Assignee: COBE Laboratories Incorporated (Terumo Corporation)
• Inventors: Martin, Scott, Fletcher-Haynes, Peter, Gordon, Timothy M., Scovill, Stephen K.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/747,852
• Time in Patent Office: 923 Days
• Field of Search: 604/65, 604/131, 604/66, 604/67, 604/4, 604/5, 604/6, 604/48, 604/30
• US Class Current: 604/65
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse

Abstract

A method and apparatus for occlusion monitoring in a flow circuit using pressure waveform analysis. The flow circuit includes a first conduit and a second conduit which fluidly interconnects a fluid supply with the first conduit. A pump is disposed in an intermediate portion of the second conduit. Monitoring of the pressure in the first conduit is used to identify any occlusions in that portion of the second conduit which is disposed between the pump and the fluid supply.

Claims

1. A method of monitoring for occlusion of a conduit in a flow circuit, said flow circuit comprising a first conduit having a flow therethrough, a fluid supply, a second conduit extending between said fluid supply and a first location on said first conduit at which said first and second conduits are fluidly connected, and a pump disposed between said first location and said fluid supply and interfacing with said second conduit, said method comprising the steps of:

pumping a fluid from said fluid supply through said second conduit and into said first conduit using said pump;

monitoring a pressure in said first conduit at a second location; and

monitoring for an occlusion of any portion of said second conduit disposed between said fluid supply and said pump using said monitoring a pressure step.

2. A method, as claimed in claim 1, wherein:

said pump is a peristaltic pump comprising at least one roller and said pumping a fluid step comprises progressively occluding said second conduit with said at least one roller.

3. A method, as claimed in claim 1, wherein:

said pumping a fluid step comprises at least periodically substantially isolating said fluid supply from said first conduit.

4. A method, as claimed in claim 1, wherein:

said monitoring a pressure step is performed downstream of said first location, wherein said second location is displaced from said first location.

5. A method, as claimed in claim 1, wherein:

said monitoring a pressure step comprises generating a waveform corresponding with a pressure in said first conduit at said second location.

6. A method, as claimed in claim 1, wherein:

said monitoring a pressure step comprises generating a signal corresponding with a pressure in said first conduit at said second location and processing said signal to account for at least noise in at least part of said flow circuit.

7. A method, as claimed in claim 1, wherein:

said monitoring a pressure step comprises generating a computer-readable signal corresponding with a pressure in said first conduit at said second location.

8. A method, as claimed in claim 1, wherein:

said monitoring for an occlusion step comprises monitoring for a pattern of a plurality of negative pressure spikes of at least a certain magnitude from said monitoring a pressure step.

9. A method, as claimed in claim 1, wherein:

said monitoring for an occlusion step comprises monitoring for a pattern of a plurality of negative pressure spikes, each having at least a certain magnitude and a predetermined width.

10. A method, as claimed in claim 1, wherein:

said pumping a fluid step comprises sequentially and progressively occluding said second conduit using a plurality of spaced rollers of a peristaltic pump, said monitoring for an occlusion step comprising monitoring for a pressure waveform in which there are a plurality of negative pressure spikes of at least a certain magnitude, a time between adjacent said negative pressure spikes corresponding with a time which is equal to an inverse of a product of a rotational speed of said peristaltic pump and a number of said rollers used by said peristaltic pump.

11. A method, as claimed in claim 10, further comprising the step of:

introducing a first occlusion in a portion of said second conduit between said pump and said fluid supply and generating a negative pressure in a portion of said second conduit between one of said rollers performing said occluding step and said first occlusion in said second conduit, wherein said pumping step further comprises the step of sequentially releasing an occlusion in said second conduit, said method further comprising the step of drawing fluid from said first conduit and a portion of said second conduit between said pump and said first location toward said first occlusion in said second conduit after each said releasing step and using said generating step, each said drawing step producing a corresponding pressure drop at said second location to produce one of said pressure spikes.

12. A method, as claimed in claim 1, wherein:

said monitoring for an occlusion step comprises detecting a substantially 100% occlusion in said second conduit between said pump and said fluid supply.

13. A method, as claimed in claim 1, wherein:

said monitoring for an occlusion step comprises detecting at least about a 50% occlusion in said second conduit between said pump and said fluid supply.

14. A method, as claimed in claim 1, wherein:

said monitoring for an occlusion step comprises detecting at least about a 28% occlusion in said second conduit between said pump and said fluid supply.

15. A method, as claimed in claim 1, further comprising the step of:

providing an alarm when an occlusion in any portion of said second conduit disposed between said fluid supply and said pump is identified from said monitoring for an occlusion step.

16. A method of monitoring for occlusion of a conduit in an extracorporeal blood processing system, said blood processing system comprising a blood supply, a blood processing device, a blood inlet conduit extending between said blood supply and said blood processing device, a blood inlet pump disposed between said blood supply and said blood processing device and interfacing with said blood inlet conduit at a first location, an anticoagulant supply, an anticoagulant conduit extending between said anticoagulant supply and a second location on said blood inlet conduit at which said blood inlet conduit and said anticoagulant conduit are fluidly connected, and an anticoagulant pump disposed between said second location and said anticoagulant supply and interfacing with said anticoagulant conduit, said method comprising the steps of:

pumping blood from said blood supply to said blood processing device through said blood inlet conduit using said blood inlet pump;

pumping anticoagulant from said anticoagulant supply through said anticoagulant conduit and into said blood inlet conduit using said anticoagulant pump;

monitoring a pressure in said blood inlet conduit at a third location; and

monitoring for an occlusion of any portion of said anticoagulant conduit located between said anticoagulant supply and said anticoagulant pump using said monitoring a pressure step.

17. A method, as claimed in claim 16, wherein:

said anticoagulant pump is a peristaltic pump comprising at least one roller and said pumping anticoagulant step comprises progressively occluding said anticoagulant conduit with said at least one roller.

18. A method, as claimed in claim 16, wherein:

said pumping anticoagulant step comprises at least periodically substantially isolating said anticoagulant supply from said blood inlet conduit.

19. A method, as claimed in claim 16, wherein:

said third location is located between said first location and said second location.

20. A method, as claimed in claim 16, wherein:

said monitoring a pressure step comprises generating a waveform corresponding with a pressure in said blood inlet conduit at said third location.

21. A method, as claimed in claim 16, wherein:

said monitoring a pressure step comprises generating a signal corresponding with a pressure in said blood inlet conduit at said third location and processing said signal to account for at least noise due to said blood inlet pump.

22. A method, as claimed in claim 16, wherein:

said monitoring a pressure step comprises generating a computer-readable signal corresponding with a pressure in said blood inlet conduit at said third location.

23. A method, as claimed in claim 16, wherein:

said monitoring for an occlusion step comprises monitoring for a pattern of a plurality of negative pressure spikes of at least a certain magnitude from said monitoring a pressure step.

24. A method, as claimed in claim 16, wherein:

said monitoring for an occlusion step comprises monitoring for a certain pattern of a plurality of negative pressure spikes, each having at least a certain magnitude and a predetermined width.

25. A method, as claimed in claim 16, wherein:

said pumping anticoagulant step comprises sequentially and progressively occluding said anticoagulant conduit using a plurality of spaced rollers of said anticoagulant pump, said monitoring for an occlusion step comprising monitoring for a certain pressure versus time waveform in which there are a plurality of negative pressure spikes of at least a certain magnitude, a time between adjacent said negative pressure spikes corresponding with a time which is equal to an inverse of a product of a rotational speed of said anticoagulant pump and a number of said rollers used by said anticoagulant pump.

26. A method, as claimed in claim 25, further comprising the step of:

introducing a first occlusion in a portion of said anticoagulant conduit between said anticoagulant pump and said anticoagulant supply and generating a negative pressure in a portion of said anticoagulant conduit between one of said rollers performing said occluding step and said first occlusion in said anticoagulant conduit, wherein said pumping anticoagulant step further comprises the step of sequentially releasing an occlusion in said anticoagulant conduit, said method further comprising the step of drawing fluid from said blood inlet conduit and a portion of said anticoagulant conduit between said anticoagulant pump and said second location toward said first occlusion in said anticoagulant conduit after each said releasing step and using said generating step, each said drawing step producing a corresponding pressure drop at said third location to produce one of said pressure spikes.

27. A method, as claimed in claim 16, wherein:

said monitoring for an occlusion step comprises detecting at least about a 50% occlusion in said anticoagulant conduit between said anticoagulant pump and said anticoagulant supply.

28. A method, as claimed in claim 16, further comprising the step of:

providing an alarm when an occlusion in any portion of said anticoagulant conduit disposed between said anticoagulant supply and said anticoagulant pump is identified from said monitoring for an occlusion step.

29. A flow circuit, comprising:

a first conduit;

a fluid supply;

a second conduit extending between said fluid supply and a first location on said first conduit at which said first and second conduits are fluidly connected;

a pump disposed between said first location on said first conduit and said fluid supply and interfacing with said second conduit;

a pressure sensing device interfacing with said first conduit at a second location; and

means for monitoring for an occlusion of any portion of said second conduit disposed between said fluid supply and said pump, said means for monitoring comprising said pressure sensing device.

30. A flow circuit, as claimed in claim 29, wherein:

said pump is a peristaltic pump comprising at least one roller which progressively occludes said second conduit.

31. A flow circuit, as claimed in claim 29, further comprising:

means for periodically substantially isolating said fluid supply from said first conduit, said means for periodically substantially isolating comprising said pump.

32. A flow circuit, as claimed in claim 29, wherein:

said second location is downstream of said first location.

33. A flow circuit, as claimed in claim 29, wherein:

said means for monitoring comprises means for generating a waveform corresponding with a pressure in said first conduit at said second location.

34. A flow circuit, as claimed in claim 33, wherein:

said means for monitoring comprises means for monitoring said waveform for a pattern of a plurality of negative pressure spikes of at least a certain magnitude.

35. A flow circuit, as claimed in claim 33, wherein:

said means for monitoring comprises means for monitoring said waveform for a pattern of a plurality of negative pressure spikes, each having at least a certain magnitude and a predetermined width.

36. A flow circuit, as claimed in claim 33, wherein:

said pump comprises a peristaltic pump with a plurality of rollers which sequentially, progressively occlude said second conduit, said means for monitoring comprising means for monitoring said waveform for a plurality of negative pressure spikes of at least a certain magnitude, a time between adjacent said negative pressure spikes corresponding with a time which is equal to an inverse of a product of a rotational speed of said peristaltic pump and a number of said rollers used by said peristaltic pump.

37. A flow circuit, as claimed in claim 33, wherein:

said means for monitoring comprises means for monitoring said waveform for a pattern of a plurality of negative pressure spikes and means for accentuating said negative pressure spikes.

38. A flow circuit, as claimed in claim 29, wherein:

said means for monitoring comprises means for generating a signal corresponding with a pressure in said first conduit at said second location and means for processing said signal to account for at least noise in at least part of said flow circuit.

39. A flow circuit, as claimed in claim 29, wherein:

said means for monitoring comprises means for generating a computer-readable signal corresponding with a pressure in said first conduit at said second location.

40. A flow circuit, as claimed in claim 29, further comprising:

an alarm interconnected with said means for monitoring, wherein said alarm is activated when an occlusion in any portion of said second conduit disposed between said fluid supply and said pump is identified by said means for monitoring.