Patient-side occlusion detection system for a medication infusion system

• US 4,863,425 A
• Filed: 12/04/1987
• Issued: 09/05/1989
• Est. Priority Date: 12/04/1987
• Status: Expired due to Term

• Current Assignee: Cardinal Health 303 Incorporated (Cardinal Health, Inc.)
• Original Assignee: Pacesetter Infusion, Ltd. (Siemens AG)
• Inventors: Henke, James L., Slate, John B.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Lacyk, John P.
• Application Number:
  US07/129,013
• Time in Patent Office: 641 Days
• Field of Search: 604/65, 604/66, 604/67, 128/DIG. 12, 128/DIG. 13
• US Class Current: 604/65
• CPC Class Codes: A61M 2005/16868 Downstream occlusion sensors
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

A system for detecting an occlusion in a fluid line is disclosed which can detect occlusions in the downstream or patient side of a disposable cassette containing a fluid pump thereon. The cassette includes a pressure diaphragm and is for installation onto and use with a main pump unit including a pressure transducer therein for monitoring fluid pressure downstream of the pump. The system utilizes control circuitry to provide an alarm in the event of a patient-side occlusion, and the occlusion detection system works when the system is configured as any of a number of difference device types, including both a flow controller emulation and several different infusion pump configurations.

Claims

1. A patient-side occlusion detection system for use in a medication infusion system having a disposable cassette including a pump mounted onto a main pump unit, comprising:

means for providing an electrical patient-side pressure signal indicative of patient-side fluid pressure;

a differentiator for taking the first difference of said patient-side pressure signal to produce a pressure change rate signal;

a one-step ahead predictor having as inputs said patient-side pressure signal and said pressure change rate signal, said one-step ahead predictor having as an output a predicted future pressure signal;

first means for monitoring said one-step ahead predictor whenever said pressure change rate signal equals or exceeds a first preselected value, said first monitoring means initiating an alarm when said predicted future pressure signal exceeds a second preselected value; and

second means for monitoring said patient-side pressure signal whenever said pressure change rate signal is less than said first preselected value, said second monitoring means initiating an alarm when said patient-side pressure signal exceeds a third preselected value.

2. A patient-side occlusion detection system as defined in claim 1, wherein said providing means comprises:

means for producing an analog electrical patient-side pressure signal indicative of patient-side fluid pressure; and

an analog-to-digital converter for converting said analog electrical patient-side pressure signal into said patient-side pressure signal.

3. A patient-side occlusion detection system as defined in claim 2, wherein said producing means comprises:

a pressure diaphragm in said cassette; and

a pressure transducer in said main pump unit for producing said analog electrical patient-side pressure signal in response to pressure from said pressure diaphragm against said pressure transducer.

4. A patient-side occlusion detection system as defined in claim 3, wherein said pressure transducer periodically samples said patient-side fluid pressure to produce said analog electrical patient-side pressure signal.

5. A patient-side occlusion detection system as defined in claim 4, additionally comprising:

an amplifier for amplifying said analog electrical patient-side pressure signal produced by said pressure transducer; and

a filter for filtering the amplified analog electrical patient-side pressure signal produced by said amplifier.

6. A patient-side occlusion detection system as defined in claim 5, wherein said filter is a first order low pass filter.

7. A patient-side occlusion detection system as defined in claim 2, wherein said analog-to-digital converter comprises:

means for periodically sampling said analog electrical patient-side pressure signal; and

means for quantizing the sampled analog electrical patient-side pressure signal form said sampling means, the output of said quantizing means being said patient-side pressure signal, said patient-side pressure signal being a digital signal.

8. A patient-side occlusion detection system as defined in claim 7, wherein said sampling means comprises a sampler, and said quantizing means comprises an eight-bit quatizer, the sampling period T of the sampler being the largest interval maintaining only a preselected amount of overshoot and udershoot in said predicted future pressure signal when compared to said patient-side pressure signal.

9. A patient-side occlusion detection system as defined in claim 7, additionally comprising:

a first order analog filter for filtering said analog electrical patient-side pressure signal before it is sampled by said sampling means, said analog filter having a time constant of τ

₁, said sampling means having a sampling period of T, wherein said first means uses the formula P_k+1 =(τ

₁ +T)*P_k +P_k to compute a value for the predicted future pressure signal P_k+1, where P_k is said patient-side pressure signal, P_k is said first difference of said patient-side pressure signal, and P_k+1 is said predicted future pressure signal.

10. A patient-side occlusion detection system as defined in claim 1, wherein said first preselected value is approximately five PSI/sec.

11. A patient-side occlusion detection system as defined in claim 1, wherein said medication infusion system may be configured as any of a plurality of different types of pumps, wherein said second preselected value is approximately six PSI if said medication infusion system is configured as a flow controller, or fifteen PSI if said medication infusion system is configured as a device other than a flow controller.

12. A patient-side occlusion detection system as defined in claim 1, wherein said second monitoring means comprises:

flow controller monitoring means for monitoring said patient-side pressure signal whenever said pressure change rate signal is less than said first preselected value and said medication infusion system is configured as a flow controller; and

infusion pump monitoring means for monitoring said patient-side pressure signal whenever said pressure change rate signal is less than said first preselected value and said medication infusion system is configured as an infusion pump other than a flow controller.

13. A patient-side occlusion detection system as defined in claim 12, wherein said flow controller monitoring means compares said patient-side pressure signal to said third preselected value and produces an alarm whenever said patient-side pressure signal equals or exceeds said third preselected value, said third preselected value being between one and one-half and six feet of water.

14. A patient-side occlusion detection system as defined in claim 13, additionally comprising:

a first order low pass filter for filtering said patient-side pressure signal before it is compared to said third preselected value.

15. A patient-side occlusion detection system as defined in claim 12, wherein the pump in the disposable cassette is a reciprocating pump operating in successive strokes, beginning a pumping operation with a first stroke, followed by a second stroke and a third stroke, wherein said infusion pump monitoring means comprises:

means for monitoring said patient-side pressure signal from the beginning of the second stroke of said pump to the beginning of the third stroke of said pump;

means for averaging said monitored patient-side pressure signal from the beginning of the second stroke of said pump to produce a baseline pressure; and

means for initiating an alarm when said patient-side pressure signals exceeds the sum of said baseline pressure plus a fourth preselected value.

16. A patient-side occlusion detection system as defined in claim 15, wherein said monitoring and averaging steps are performed each time an infusion regimen is first initiated by said medication infusion system, and each time the infusion rate of said medication infusion system is changed.

17. A patient-side occlusion detection system as defined in claim 15, wherein said medication infusion system may be configured as any of a plurality of different types of pumps, wherein said fourth preselected value is approximately one PSI if said medication infusion system is configured as a neonatal pump, approximately ten PSI if said medication infusion system is configured as an operating room pump, and approximately five PSI if said medication infusion system is configured as a general purpose pump.

18. A patient-side occlusion detection system as defined in claim 15, additionally comprising:

override means for initiating an alarm whenever said patient-side pressure signal is equal to or exceeds a fifth preselected value, even if said patient-side pressure signal is less than said sum of said baseline pressure plus said fourth preselected value.

19. A patient-side occlusion detection system as defined in claim 18, wherein said fifth preselected value is approximately fifteen PSI.

20. A patient-side occlusion detection system for use in a medication infusion system having a disposable cassette mounted onto a main pump unit, comprising:

means for providing an analog electrical pressure signal indicative of patient-side fluid pressure;

an analog-to-digital converter for converting said analog pressure signal into a digital pressure signal;

a differentiator for taking the first difference of said digital pressure signal to produce a digital pressure change rate signal having a sampling period T;

a one-step ahead predictor having as inputs said digital pressure signal and said digital pressure change rate signal, said one-step ahead predictor having as an output a predicted pressure signal for one sampling period T in the future;

first means for monitoring said one-step ahead predictor whenever said digital pressure change rate signal equals or exceeds a first preselected value, said first monitoring means initiating an alarm when said predicted pressure signal exceeds a second preselected value; and

second means for monitoring said digital pressure signal whenever said digital pressure change rate signal is less than said first preselected value, said second monitoring means initiating an alarm when said digital pressure signal exceeds a third preselected value.

21. A patient-side occlusion detection system for use in a medication infusion system having a disposable cassette mounted onto a main pump unit, comprising:

means for providing a digital electrical pressure signal indicative of patient-side fluid pressure;

means for taking the first difference of said digital pressure signal to produce a digital pressure change rate signal having a sampling period T;

a one-step ahead predictor having as inputs said digital pressure signal and said digital pressure change rate signal, said one-step ahead predictor having as an output a predicted pressure signal for one sampling period T in the future;

first means for monitoring said one-step ahead predictor whenever said digital pressure change rate signal equals or exceeds a first preselected value, said first monitoring means initiating an alarm when said predicted pressure signal exceeds a second preselected value; and

second means for monitoring said digital pressure signal whenever said digital pressure change rate signal is less than said first preselected value, said second monitoring means calculating a baseline pressure shortly after infusion is begun, said second monitoring means initiating an alarm when said digital pressure signal exceeds the sum of said baseline pressure plus a third preselected value.

22. A method of detecting a patient-side occlusion in a medication infusion system having a disposable cassette mounted onto a main pump unit, comprising:

providing an electrical patient-side pressure signal indicative of patient-side fluid pressure;

taking the first difference of said patient-side pressure signal to produce a pressure change rate signal having a sampling period T;

using a one-step ahead predictor to calculate a predicted pressure signal for one sampling period T in the future, said one-step ahead predictor having as inputs said patient-side pressure signal and said pressure change rate signal;

monitoring said one-step ahead predictor whenever said pressure change rate signal equals or exceeds a first preselected value, said first monitoring means initiating an alarm when said predicted pressure signal exceeds a second preselected value; and

monitoring said patient-side pressure signal whenever said pressure change rate signal is less than said first preselected value, said second monitoring means initiating an alarm when said patient-side pressure signal exceeds a third preselected value.