Method and apparatus for the early diagnosis of subacute, potentially catastrophic illness

• US 6,216,032 B1
• Filed: 03/17/1999
• Issued: 04/10/2001
• Est. Priority Date: 03/17/1998
• Status: Expired due to Term

• Current Assignee: University of Virginia Patent Foundation (University of Virginia)
• Original Assignee: University of Virginia Patent Foundation (University of Virginia)
• Inventors: Moorman, J. Randall, Griffin, M. Pamela
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US09/271,279
• Time in Patent Office: 755 Days
• Field of Search: 600/515, 600/516, 600/518, 600/519
• US Class Current: 600/515
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/02411 of foetuses
• CPC Class Codes: A61B 5/344 Foetal cardiography
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/4362 Assessing foetal parameters
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

In one aspect, there is provided a method and apparatus for early detection of subacute, potentially catastrophic infectious illness in a premature newborn infant. The method comprises: (a) continuously monitoring heart rate variability in the premature newborn infant; and (b) identifying at least one characteristic abnormality in the heart rate variability that is associated with the illness. This method can be use to diagnose illnesses such as, but not limited to, sepsis, necrotizing enterocolitis, pneumonia and meningitis. In another aspect, there is provided a method and apparatus for early detection of subacute, potentially catastrophic infectious illness in a patient. The method comprises: (a) continuously monitoring the patient'"'"'s RR intervals; (b) generating a normalized data set of the RR intervals; (c) calculating one or more of (i) moments of the data set selected from the third and higher moments and (ii) percentile values of the data set; and (d) identifying an abnormal heart rate variability associated with the illness based on one or more of the moments and the percentile values.

Claims

1. A method for early detection of subacute, potentially catastrophic infectious illness in a premature newborn infant comprising:

(a) continuously monitoring heart rate variability in the premature newborn infant; and

(b) identifying at least one characteristic abnormality in the heart rate variability that is associated with the illness.

2. The method of claim 1, wherein the illness is sepsis.

3. The method of claim 2, wherein antibiotic therapy is initiated and a diagnostic work-up for the illness, comprising obtaining a blood culture from the newborn infant, is provided when the at least one characteristic abnormality is identified.

4. The method of claim 1, wherein the illness is necrotizing enterocolitis.

5. The method of claim 4, wherein a diagnostic work-up for the illness, comprising an X-ray of the newborn infant or a pathological specimen from the newborn infant, is provided when the at least one characteristic abnormality is identified.

6. The method of claim 1, wherein the illness is selected from the group consisting of pneumonia and meningitis.

7. The method of claim 1, wherein the at least one characteristic abnormality is identified from a normalized data set of RR intervals.

8. The method of claim 7, wherein the data set contains on the order of about 10³ to 10⁴ sequential RR intervals.

9. The method of claim 7, wherein the at least one characteristic abnormality is identified based on at least one of the third and higher moments of the data set.

10. The method of claim 9, wherein the at least one moment of the data set includes the skewness of the data set.

11. The method of claim 10, wherein the illness is selected from the group consisting of sepsis and necrotizing enterocolitis.

12. The method of claim 10, further comprising a diagnostic work-up.

13. The method of claim 9, wherein the wherein the at least one moment of the data set includes the kurtosis of the data set.

14. The method of claim 13, wherein the illness is selected from the group consisting of sepsis and necrotizing enterocolitis.

15. The method of claim 13, further comprising a diagnostic work-up.

16. The method of claim 7, wherein the at least one characteristic abnormality is identified based on at least one percentile value of the data set.

17. The method of claim 16, wherein the at least one percentile value is the 10th percentile value.

18. The method of claim 17, wherein the illness is selected from the group consisting of sepsis and necrotizing enterocolitis.

19. The method of claim 17, further comprising a diagnostic work-up.

20. The method of claim 7, wherein the at least one characteristic abnormality is identified based on the variance, standard deviation or coefficient of variation of the data set.

21. The method of claim 20, wherein the illness is selected from the group consisting of sepsis and necrotizing enterocolitis.

22. The method of claim 20, further comprising a diagnostic work-up.

23. The method of claim 1, wherein a diagnostic work-up is provided when the at least one characteristic abnormality is identified.

24. A method for early detection of subacute, potentially catastrophic infectious illness in a patient comprising:

(a) continuously monitoring the patient'"'"'s RR intervals;

(b) generating a normalized data set of the RR intervals;

(c) calculating one or more of (i) moments of the data set selected from the third and higher moments and (ii) percentile values of the data set; and

(d) identifying an abnormal heart rate variability associated with the illness based on one or more of the moments and the percentile values.

25. The method of claim 24, wherein the moments include the third moment of the data set.

26. The method of claim 24, wherein the moments include the fourth moment of the data set.

27. The method of claim 24, wherein the percentile values include the 10th percentile value.