Fuzzy logic alarm system for pulse oximeters

• US 5,830,135 A
• Filed: 03/31/1994
• Issued: 11/03/1998
• Est. Priority Date: 03/31/1994
• Status: Expired due to Fees

• Current Assignee: Elena M. Bosque, Steven L. Goldman, William Siler
• Original Assignee: Elena M. Bosque, Steven L. Goldman, William Siler
• Inventors: Bosque, Elena M., Goldman, Steven L., Siler, William
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US08/220,544
• Time in Patent Office: 1,678 Days
• Field of Search: 128/633-4, 128/664-7, 356/39-41
• US Class Current: 600/323
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A new alarm system for pulse oximeters, based on fuzzy logic, will differentiate false alarms, caused by artifact, from true alarms. Numeric input variables and corresponding fuzzy sets (oxygen saturation HIGH (high O2), NO (normal O2) and YES (desaturation) and rate of change of oxygen saturation (HIGH, MEDIUM and LOW) and their membership functions are defined. An output fuzzy set ARTIFACT is defined. Input voltages from the pulse oximeter are sampled and converted to digital form. The sampled voltages are converted by the membership functions into confidences that each fuzzy set descriptor for oxygen desaturation and reate of change apply. Rules are specified which result in confidences that the fuzzy set descriptors for ARTIFACT apply. Further rules govern the issuance of alarms for oxygen desaturation or for artifacts, momentary or continuous, so that the nurse can take appropriate action. The fuzzy logic alarm system program is written in Quick Basic 4.5, by Microsoft (R). The advantage of using the fuzzy logic alarm system for a pulse oximeter used in infants is that there will be at least 34% fewer false alarms. Pulse oximeter alarms which better reflect the actual situation will improve the specificity of the alarm system and may decrease the potential "Cry Wolf" response of the caretaker, which now exists.

Claims

1. A method for differentiating artifact from true oxygen saturation signals using pulse oximetry and a computer system comprising:

a) generating an oxygen saturation signal which may correspond to the oxygen saturation level in a subject'"'"'s blood;

b) storing the oxygen saturation signal in a data storage area of the computer system;

c) applying a fuzzy logic alarm system computer program to the oxygen saturation signal stored in the computer system in order to determine whether the stored oxygen saturation signal is a true signal actually corresponding to the oxygen saturation level in a subject'"'"'s blood or an artifact, the fuzzy logic alarm system computer program comprising fuzzy sets;

linguistic variables;

membership functions;

confidence values;

rules and constraints;

membership functions for unions of fuzzy sets;

membership functions for triangulations of fuzzy sets; and

decision sets; and

d) generating a detectable indicator signal based upon the determination made when applying the fuzzy logic alarm system computer program to the stored oxygen saturation signal to indicate a state of the oxygen saturation signal;

wherein one of the fuzzy sets includes rate of change of heart rate data.

2. The method of claim 1 wherein the detectable indicator signal indicates one of the following states:

momentary artifact;

continuous artifact;

normal oxygen saturation;

oxygen desaturation; and

, oxygen oversaturation.

3. The method of claim 1 wherein between the generating and storing the oxygen saturation signal steps, the method comprises the further step of converting the oxygen saturation signal to a digital data signal.

4. A method for differentiating artifact from true oxygen saturation signals using pulse oximetry and a computer system, comprising:

a) generating an oxygen saturation signal which may correspond to the oxygen saturation level in a subject'"'"'s blood;

b) converting the oxygen saturation signal to a data signal;

c) storing the data signal in a data storage area of the computer system;

d) applying a fuzzy logic alarm system computer program to the data signal stored in the data storage area of the computer system in order to determine whether the data signal is a true signal actually corresponding to the oxygen saturation level in a subject'"'"'s blood or an artifact, the fuzzy logic alarm system computer program comprising fuzzy sets;

linguistic variables;

membership functions;

confidence values;

rules and constraints;

membership functions for unions of fuzzy sets;

membership functions for triangulations of fuzzy sets; and

decision sets; and

,

e) generating a detectable indicator signal based upon the determination made when applying the fuzzy logic alarm system computer program to the stored data signal to indicate a state of the data signal;

wherein one of the fuzzy sets includes rate of change of heart rate data.

5. The method of claim 4 wherein the detectable indicator signal indicates one of the following states:

momentary artifact;

continuous artifact;

normal oxygen saturation;

oxygen desaturation; and

, oxygen oversaturation.

6. An apparatus for differentiating artifact from true oxygen saturation signals using a computer system with data storage and data processing capabilities, comprising:

a) means for generating an oxygen saturation signal which may correspond to the oxygen saturation level in a subject'"'"'s blood;

b) means for storing the oxygen saturation signal in a data storage area of the computer system;

c) means for applying a fuzzy logic alarm system computer program to the oxygen saturation signal stored in the data storage area of the computer system in order to determine whether the stored oxygen saturation signal is a true signal actually corresponding to the oxygen saturation level in a subject'"'"'s blood or an artifact, the fuzzy logic alarm system computer program comprising fuzzy sets;

linguistic variables;

membership functions;

confidence values;

rules and constraints;

membership functions for unions of fuzzy sets;

membership functions for triangulations of fuzzy sets; and

decision sets; and

,

d) means for generating a detectable indicator signal based upon the determination made when applying the fuzzy logic alarm system computer program to the stored oxygen saturation signal to indicate a state of the oxygen saturation signal;

wherein one of the fuzzy sets includes rate of change of heart rate data.

7. The apparatus of claim 6 wherein the detectable indicator signal means indicates one of the following states:

momentary artifact;

continuous artifact;

normal oxygen saturation;

oxygen desaturation; and

, oxygen oversaturation.

8. An apparatus for differentiating artifact from true oxygen saturation signals using a computer system with data storage and data processing capabilities, comprising:

a) means for generating an oxygen saturation signal which may correspond to the oxygen saturation level in a subject'"'"'s blood;

b) means for converting the oxygen saturation signal to a data signal;

c) means for storing the data signal in a data storage area of the computer system;

d) means for applying a fuzzy logic alarm system computer program to the data signal stored in the data storage area of the computer system in order to determine whether the data signal is a true signal actually corresponding to the oxygen saturation level in a subject'"'"'s blood or an artifact, the fuzzy logic alarm system computer program comprising fuzzy sets;

linguistic variables;

membership functions;

confidence values;

rules and constraints;

membership functions for unions of fuzzy sets;

membership functions for triangulations of fuzzy sets; and

decision sets; and

,

e) means for generating a detectable indicator signal based upon the determination made when applying the fuzzy logic alarm system computer program to the stored data signal to indicate a state of the data signal;

wherein one of the fuzzy sets includes rate of change of heart rate data.

9. The apparatus of claim 8 wherein the detectable indicator signal means indicates one of the following states:

momentary artifact;

continuous artifact;

normal oxygen saturation;

oxygen desaturation; and

, oxygen oversaturation.

10. An apparatus for differentiating artifact from true oxygen saturation signals using a pulse oximeter with data storage and data processing capabilities, comprising:

a) a pulse oximeter for generating an oxygen saturation signal which may correspond to the oxygen saturation level in a subject'"'"'s blood;

b) means for storing the oxygen saturation signal in a data storage area of the pulse oximeter;

c) means for applying a fuzzy logic alarm system computer program to the stored oxygen saturation signal stored in the pulse oximeter data storage area in order to determine whether the stored oxygen saturation signal is a true signal actually corresponding to the oxygen saturation level in a subject'"'"'s blood or an artifact, the fuzzy logic alarm system computer program comprising fuzzy sets;

linguistic variables;

membership functions;

confidence values;

rules and constraints;

membership functions for unions of fuzzy sets;

membership functions for triangulations of fuzzy sets; and

decision sets; and

,

d) means for generating a detectable indicator signal based upon the determination made when applying the fuzzy logic alarm system computer program to the stored oxygen saturation signal to indicate a state of the oxygen saturation signal;

wherein one of the fuzzy sets includes rate of change of heart rate data.

11. The apparatus of claim 10 wherein the fuzzy logic alarm system computer program is stored in a fuzzy logic computer chip contained within the pulse oximeter.

12. The apparatus of claim 10 wherein the detectable indicator signal means indicates one of the following states:

momentary artifact;

continuous artifact;

normal oxygen saturation;

oxygen desaturation; and

, oxygen oversaturation.

13. An apparatus for differentiating artifact from true oxygen saturation signals using a pulse oximeter and a computer system with data storage and data processing capabilities, comprising:

a) a pulse oximeter for generating an oxygen saturation signal which may correspond to the oxygen saturation level in a subject'"'"'s blood;

b) means for storing the oxygen saturation signal in a data storage area of the computer system;

c) means for applying a fuzzy logic alarm system computer program to the stored oxygen saturation signal in order to determine whether the stored oxygen saturation signal is a true signal actually corresponding to the oxygen saturation level in a subject'"'"'s blood or an artifact, the fuzzy logic alarm system computer program comprising fuzzy sets;

linguistic variables;

membership functions;

confidence values;

rules and constraints;

membership functions for unions of fuzzy sets;

membership functions for triangulations of fuzzy sets; and

decision sets; and

,

d) means for generating a detectable indicator signal in the pulse oximeter based upon the determination made when applying the fuzzy logic alarm system computer program to the stored oxygen saturation signal to indicate a state of the oxygen saturation signal;

wherein one of the fuzzy sets includes rate of change of heart rate data.

14. The apparatus of claim 13 wherein the detectable indicator signal means indicates one of the following states:

momentary artifact;

continuous artifact;

normal oxygen saturation;

oxygen desaturation; and

, oxygen oversaturation.

15. An apparatus for differentiating artifact from true oxygen saturation signals using a pulse oximeter and a computer system with data storage and data processing capabilities, comprising:

a) a pulse oximeter for generating an oxygen saturation signal which may correspond to the oxygen saturation level in a subject'"'"'s blood;

b) means for storing the oxygen saturation signal in a data storage area of the computer system;

c) means for applying a fuzzy logic alarm system computer program to the stored oxygen saturation signal in order to determine whether the stored oxygen saturation signal is a true signal actually corresponding to the oxygen saturation level in a subject'"'"'s blood or an artifact, the fuzzy logic alarm system computer program comprising fuzzy sets;

linguistic variables;

membership functions;

confidence values;

rules and constraints;

membership functions for unions of fuzzy sets;

membership functions for triangulations of fuzzy sets; and

decision sets; and

,

d) means for generating a detectable indicator signal in the computer system based upon the determination made when applying the fuzzy logic alarm system computer program to the stored oxygen saturation signal to indicate a state of the oxygen saturation signal;

wherein one of the fuzzy sets includes rate of change of heart rate data.

16. The apparatus of claim 15 wherein the detectable indicator signal means indicates one of the following states:

momentary artifact;

continuous artifact;

normal oxygen saturation;

oxygen desaturation; and

, oxygen oversaturation.