Data processing: measuring – calibrating – or testing – Measurement system in a specific environment – Chemical analysis
Reexamination Certificate
1998-08-19
2001-07-31
Hoff, Marc S. (Department: 2857)
Data processing: measuring, calibrating, or testing
Measurement system in a specific environment
Chemical analysis
C128S920000
Reexamination Certificate
active
06269314
ABSTRACT:
FIELD OF THE INVENTION
This invention concerns a blood sugar measuring device to measure the blood sugar value in the body non-invasively or only slightly invasively.
BACKGROUND OF THE INVENTION
Prior art devices to measure blood sugar in the body non-invasively are spectroscopic devices which irradiate the body with visible, near infrared or infrared light and analyze the spectrum of either the light which passes through the body or the light reflected by it. For example, the devices disclosed in Japanese Patent Publications 3-173535 and 5-176917 project a near-infrared beam into the patient's body and estimate the concentration of glucose in the body by measuring the intensity of the light which passes through. The devices disclosed in Japanese Patent Publications 2-286132 and 4-144545 extract a small quantity of humor (body fluid) from the body and measure the concentration of glucose in this humor. In addition to these devices, various other devices have been invented to measure blood sugar either non-invasively or with very slight invasiveness, but to date none have been practically realized.
The reason why none of these non-invasive or slightly invasive devices to measure blood sugar is yet on the market becomes clear when we consider that the measurement is to be used to help diabetics control the concentration of glucose in their bodies. It is because the devices which have been invented up until now have not achieved the level of accuracy required in such an apparatus. In the conventional blood sugar measuring devices which measure the blood sugar in a non-invasive or slightly invasive manner, the absolute sugar value in the blood cannot be directly measured. In such a non-invasive device, it is necessary to know the actual length of the optical path in the body in order to measure the sugar value from the optical absorption of the light emitted by the optical device. It is, however, not possible to measure such an actual length of the optical path if the device measures only the light reflected on the skin or passed through the body. In the slightly invasive measuring device, it measures only the concentration of glucose in the humor extracted from body, but not in the blood itself. These are the reasons why there is no actual device which was released in the market.
For example, a non-invasive device using a light beam does not specifically measure the biochemical blood glucose level, but merely estimates the glucose value from the quantity of light which passes through the body. When it is affected by stray light or changes in the physiological state, the calculated result can, unfortunately, turn out to be a negative value for blood sugar or a value so large it is physically impossible. Even when a slightly invasive method is used to measure the blood sugar, large measurement errors can occur, either because such a small quantity of humor is used or because the concentration of sugar in the humor is so low.
It is, therefore, necessary to adjust the measured value in order to obtain an accurate blood sugar value with such a non-invasive type of blood sugar measuring device. It might be possible to adjust the measured sugar value manually, but it is not practical because errors may happen during the adjustment procedures or while inputting adjustment factors in the measuring device. In the prior arts, there is no automatic adjustment function to adjust the measured blood sugar value.
SUMMARY OF THE INVENTION
In view of the problem of large measurement error which was discussed above, the present invention provides a blood sugar measuring device to measure blood sugar either non-invasively or with only slight invasiveness which is capable of better measurement accuracy. In this application, the terms “slight invasiveness” or “slightly invasive” are used to denote procedures and devices which in use either do not break the patient's skin or mucosa or do so in a minor or insubstantial way.
The device of this invention measures blood sugar in the body either non-invasively or with only slight invasiveness. It has an inputting means to input measured data related to the blood sugar level; an adjusting means to adjust the measured blood sugar value based on the data which are previously input; and/or a retry indication means to retry said measurement if the measurement result is out of a proper and/or predetermined range.
In general, an abrupt change can be seen in the blood sugar level in the body after eating or exercising. At virtually all other times, no abrupt change will be observed. Thus if data are input before the measurement is done to indicate a situation such as eating or exercise which may cause the blood sugar level to fluctuate, these data can be used to adjust the measured (actually, estimated) blood sugar value or prompt the user to redo the measurement. This will enable a more accurate measurement to be made. These data might include such variables as when and how much the patient last ate; when and how much he last exercised; what his most recent blood sugar level was when measured by a conventional invasive blood sugar measuring device; and what the state of his diabetes or other condition affecting blood sugar level is. The inputting means to input these data may include a keypad, voice input, the blood sugar value transmitted from a simple invasive-type blood sugar meter and physical data transmitted from a simple exercise monitor.
REFERENCES:
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Patent Abstracts of Japan, vol. 12, No. 282 (M-726), Aug. 3, 1988 & JP 63 060866, Mar. 16, 1988 abstract.
Patent Abstracts of Japan, vol. 016, No. 359 (M-1289), Aug. 4, 1992, & JP 04 112163, Apr. 18, 1992.
Hirako Shin-ichi
Iitawaki Tomoki
Sakoda Yusaku
Tokita Muneo
Hoff Marc S.
Morrison & Foerster / LLP
Omron Corporation
Raymond Edward
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