Continuous subcutaneous insulin infusion therapy

• US 8,096,983 B2
• Filed: 03/07/2006
• Issued: 01/17/2012
• Est. Priority Date: 03/07/2005
• Status: Expired due to Fees

• Current Assignee: Toho University
• Original Assignee: Juntendo University
• Inventors: Uchino, Hiroshi, Tanaka, Yasushi, Kawamori, Ryuzo
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): WITCZAK, CATHERINE
• Application Number:
  US11/817,966
• Publication Number:
  US 20080119826A1
• Time in Patent Office: 2,142 Days
• Field of Search: 604/500, 604502-504, 604506-508, 604 65- 67, 600/368
• US Class Current: 604/503
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

A mechanism for optimizing insulin infusion rate of a CSII pump for each patient. A continuous subcutaneous insulin infusion therapy uses a continuous subcutaneous insulin pump, which includes: determining a circadian variation curve representing sympathetic nerve activity and that represents parasympathetic nerve activity of a target patient; acquiring an inflection point of each of the circadian variation curves representing the two types of nerve activity; detecting a time that corresponds to the inflection point; and employing the time as a point at which the insulin infusion rate of the continuous subcutaneous insulin infusion pump is changed.

Claims

1. A continuous subcutaneous insulin infusion therapy using a continuous subcutaneous insulin pump, which comprises:

determining a circadian variation curve representing sympathetic nerve activity and a circadian variation curve representing parasympathetic nerve activity of a target patient;

acquiring inflection points of the circadian variation curve representing the sympathetic nerve activity and inflection points of the circadian variation curve representing the parasympathetic nerve activity;

detecting times which correspond to the inflection points; and

employing said times as points at which an insulin infusion rate of the continuous subcutaneous insulin infusion pump is changed.

2. The continuous subcutaneous insulin infusion therapy as described in claim 1, wherein a means for determining the circadian variation curve of the sympathetic nerve activity and the circadian variation curve representing parasympathetic nerve activity is (1) a microneurogram method, or (2) a method comprising:

conducting a power spectral analysis of heart rate variability using a heart rate data included in an electrocardiographic data obtained from a signal detected with an electrode attached to the patient; and

extracting the circadian variation curve representing the sympathetic nerve activity and the circadian variation curve representing the parasympathetic nerve activity through the power spectral analysis of heart rate variability.

3. The continuous subcutaneous insulin infusion therapy as described in claim 1, further comprising:

detecting two time points (Dip 1 and Dip 2) each corresponding to the inflection points of the circadian variation curve representing the parasympathetic nerve activity, and two time points (Dip 3 and Dip 4) each corresponding to the inflection points of the circadian variation curve representing the sympathetic nerve activity,

wherein the insulin infusion rate is increased at Dip 1, decreased at Dip 3, increased at Dip 4, and decreased at Dip 2.

4. The continuous subcutaneous insulin infusion therapy as described in claim 1, wherein the patient is notified of detection of a time which corresponds to an inflection point.

5. The continuous subcutaneous insulin infusion therapy as described in claim 1, which further comprises a means for automatically changing the insulin infusion rate in response to detection of a time which corresponds to an inflection point.

6. A method for operating a continuous subcutaneous insulin infusion pump, which comprises:

employing a circadian variation curve representing sympathetic nerve activity and a circadian variation curve representing parasympathetic nerve activity derived from a target patient for acquiring inflection points of the circadian variation curve representing the sympathetic nerve activity and inflection points of the circadian variation curve representing the parasympathetic nerve activity;

detecting times which correspond to the inflection points; and

employing said times as points at which an insulin infusion rate of the continuous subcutaneous insulin infusion pump is changed.

7. The method for operating a continuous subcutaneous insulin infusion pump as described in claim 6, wherein a means for determining the circadian variation curve of the sympathetic nerve activity and the circadian variation curve representing parasympathetic nerve activity is (1) a microneurogram method, or (2) a method comprising:

conducting a power spectral analysis of heart rate variability using a heart rate data included in an electrocardiographic data obtained from a signal detected with an electrode attached to the patient; and

extracting the circadian variation curve representing the sympathetic nerve activity and the circadian variation curve representing the parasympathetic nerve through the power spectral analysis of heart rate variability.

8. The method for operating a continuous subcutaneous insulin infusion pump as described in claim 6, further comprising:

detecting two time points (Dip 1 and Dip 2) each corresponding to the inflection points of the circadian variation curve representing the parasympathetic nerve activity, and two time points (Dip 3 and Dip 4) each corresponding to the inflection points of the circadian variation curve representing sympathetic nerve activity,

wherein the insulin infusion rate is increased at Dip 1, decreased at Dip 3, increased at Dip 4, and decreased at Dip 2.

9. The method for operating a continuous subcutaneous insulin infusion pump as described in claim 6, which further comprises a means for notifying the patient of detection of a time which corresponds to an inflection point.

10. The method for operating a continuous subcutaneous insulin infusion pump as described in claim 6, which further comprises a means for automatically changing the insulin infusion rate in response to detection of a time which corresponds to an inflection point.

11. An apparatus for continuous subcutaneous insulin infusion therapy, which comprises:

a means for determining a circadian variation curve representing sympathetic nerve activity and a circadian variation curve representing parasympathetic nerve activity of a target patient using a probe attached to a target patient;

an operational processing unit; and

a continuous subcutaneous insulin infusion pump,

wherein the operational processing unit has a means for detecting times which correspond to inflection points of the circadian variation curves representing the sympathetic nerve activity and inflection points of the circadian variation curve representing parasympathetic nerve activity to employ said times as points at which an insulin infusion rate of the continuous subcutaneous insulin infusion pump is changed.

12. The apparatus for continuous subcutaneous insulin infusion therapy as described in claim 11, wherein the means for determining the circadian variation curve representing the sympathetic nerve activity and the circadian variation curve representing the parasympathetic nerve activity is (1) a microneurogram for directly detecting the circadian variation curve representing the sympathetic nerve activity and the circadian variation curve representing the parasympathetic nerve activity of the target patient using a probe attached to the patient, or (2) a means comprising:

conducting a power spectral analysis of heart rate variability using a portable electrocardiograph for obtaining an electrocardiographic data via a probe attached to the patient and a heart rate data included in the obtained electrocardiographic data in the operational processing unit; and

extracting the circadian variation curve representing the sympathetic nerve activity and the circadian variation curve representing the parasympathetic nerve activity through the power spectral analysis of heart rate variability.

13. The apparatus for continuous subcutaneous insulin infusion therapy as described in claim 11, further comprising:

detecting two time points (Dip 1 and Dip 2) each corresponding to the inflection points of the circadian variation curve representing the parasympathetic nerve activity, and two time points (Dip 3 and Dip 4) each corresponding to the inflection points of the circadian variation curve representing the sympathetic nerve activity,

wherein the insulin infusion rate is increased at Dip 1, decreased at Dip 3, increased at Dip 4, and decreased at Dip 2.

14. The apparatus for continuous subcutaneous insulin infusion therapy as described in claim 11, which further comprises a means for notifying the patient of detection of a time which corresponds to an inflection point.

15. The apparatus for continuous subcutaneous insulin infusion therapy as described in claim 11, which further comprises a means for automatically changing the insulin infusion rate in response to the detection of a time which corresponds to an inflection point.