Monitoring device and monitoring method

• US 9,357,960 B2
• Filed: 12/04/2014
• Issued: 06/07/2016
• Est. Priority Date: 01/19/2010
• Status: Active Grant

• Current Assignee: ARKRAY, Inc
• Original Assignee: ARKRAY, Inc
• Inventors: Katsuki, Koji
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US14/560,378
• Publication Number:
  US 20150087941A1
• Time in Patent Office: 551 Days
• Field of Search: 600/345, 205/792
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2562/0271 Thermal or temperature sensors
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1491 Heated applicators
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/6849 in combination with a needle set

Abstract

A monitoring device which measures numerical value information on a subject substance in a body fluid has an electrochemical sensor including a sensor unit for detecting the subject substance which is used in the way of being embedded subcutaneously and generating an electric signal correlating to the numerical value information on the subject substance, and a temperature control unit which adjusts the detected ambient temperature as a temperature ambient to a sensor unit when detecting the subject substance so as to reach a target setting temperature when measuring the subject substance.

Claims

1. A monitoring method by which a monitoring device comprising an electrochemical sensor including a sensor unit, for detecting a subject substance in a body fluid, disposed in the way of being embedded subcutaneously, measures numerical value information on the subject substance, said method comprising:

detecting an ambient temperature with a temperature control unit, said ambient temperature being the temperature ambient to the sensor, and wherein the temperature control unit comprises a temperature sensor and a temperature adjusting element;

and

adjusting the ambient temperature with the temperature adjusting element, so as to reach a target setting temperature in the body fluid when measuring the subject substance whereby the temperature control unit controls the operation state of said temperature adjusting element on the basis of the temperature measured by said temperature sensor.

2. A monitoring method according to claim 1, further comprising:

a determining step of comparing the ambient temperature with the target setting temperature and determining whether a temperature difference between the ambient temperature and the target setting temperature is within a specified range or not; and

controlling the operation state of the temperature adjusting element for adjusting the ambient temperature so as to approximate the target setting temperature when determining in said determining step that the temperature difference exceeds the specified range,

wherein the ambient temperature when detecting the subject substance is adjusted, and wherein

said monitoring method further comprises a calculation step of calculating numerical value information on the subject substance on the basis of an electric signal generated by said electrochemical sensor when determining in said determining step that the temperature difference between the ambient temperature and the target setting temperature is within the specified range.

3. A monitoring method according to claim 2, wherein the ambient temperature is adjusted so as to reach a standby target setting temperature that is set lower than the target setting temperature when standing by for measuring the subject substance.

4. A monitoring method according to claim 2, further comprising comparing a first numerical value information defined as the numerical value information on the subject substance calculated in said calculation step and a second numerical value information defined as the numerical value information on the subject substance measured from the body fluid sampled in vitro from an examinee, and, changing the setting value of the target setting temperature when measuring the subject substance if a difference between the first numerical value information and the second numerical value information exceeds a predetermined first threshold value.

5. A monitoring method according to claim 2, further comprising adjusting the ambient temperature to reach a standby target setting temperature set lower than the target setting temperature when standing by for measuring the subject substance,

comparing a first numerical value information defined as the numerical value information on the subject substance calculated in said calculation step and a second numerical value information defined as the numerical value information on the subject substance measured from the body fluid sampled in vitro from the examinee, and

determining if the difference between the first numerical value information and the second numerical value information exceeds a predetermined second threshold value, wherein if the predetermined second threshold value is exceeded, then changing the setting value of the standby target setting temperature when standing by for measuring the subject substance on a low-temperature side.

6. A monitoring method according to claim 2, further comprising comparing a first numerical value information defined as the numerical value information on the subject substance calculated in said calculation step and a second numerical value information defined as the numerical value information on the subject substance measured from the body fluid sampled in vitro from the examinee, thereby obtaining numerical value information corresponding to a first timing after said monitoring device has started the measurement and the numerical value information corresponding to a second timing that traces back to a predetermined period from the first timing, and

changing the setting value of the target setting temperature when measuring the subject substance if a difference between the second numerical value information at the first timing and the second numerical value information at the second timing is within a predetermined third threshold value and if a difference between the first numerical value information at the first timing and the first numerical value information at the second timing exceeds a predetermined fourth threshold value.

7. A monitoring method according to claim 2, further comprising comparing a first numerical value information defined as the numerical value information on the subject substance calculated in said calculation step and a second numerical value information defined as the numerical value information on the subject substance measured from the body fluid sampled in vitro from the examinee, thereby obtaining numerical value information corresponding to a first timing after said monitoring device has started the measurement and the numerical value information corresponding to a second timing that traces back to a predetermined period from the first timing,

adjusting the ambient temperature so as to reach a standby target setting temperature that is set lower than the target setting temperature when standing by for measuring the subject substance, and

changing the setting value of the standby target setting temperature when standing by for measuring the subject substance on the low-temperature side if an elapse period reaching the first timing since the start of the measurement exceeds a predetermined reference period.