Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...
Reexamination Certificate
2002-08-02
2004-02-03
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
Measuring or detecting nonradioactive constituent of body...
C600S310000
Reexamination Certificate
active
06687521
ABSTRACT:
TECHNICAL FIELD
The present invention relates to an optical bioinstrumentation device for noninvasively measuring the concentrations of components in the living body by means of light, a measurement site holder in which the measurement site is placed, and a method of manufacturing the same.
BACKGROUND ART
For example, devices which perform spectroscopic measurements and devices which perform magnetic measurements are known as devices for acquiring information concerning the living body of a patient being examined in a noninvasive manner (noninvasive meaning that there is no need to insert a device or instrument through the skin or bodily orifices for the purpose of diagnosis or treatment). The devices described in Japanese Patent Application Laid-Open No. S60-236631 and U.S. Pat. No. 5,237,178 perform quantitative measurements of components in the living body in noninvasive manner by spectroscopic means.
The devices described in these patents are devices that measure the glucose concentration (blood sugar level) in the living body of the patient being examined in a noninvasive manner. In the device described in Japanese Patent Application Laid-Open No. S60-236631, a construction in which the ear lobe (measurement site) of the patient being examined is illuminated from the outside with light, and the transmitted light that passes through the ear lobe is detected by a photo-detector attached to the inside of the ear lobe by means of adhesive tape, a strap or the like, and a construction in which a photo-detector is applied to the surface of the patient's body (measurement site), and scattered and reflected light are detected, are disclosed.
In the device described in U.S. Pat. No. 5,237,178, a construction is disclosed in which a finger tip stopper and a sponge rubber used to hold the finger are used as finger insertion means for positioning the finger, and the transmitted light that is transmitted through the finger (measurement site) is detected by a photo-detector.
Furthermore, in conventional noninvasive measuring devices, living-body information for a plurality of patients is acquired separately, and the living-body information thus acquired for individual patients is recorded on a recording medium which is installed inside or outside the abovementioned measuring device. The living-body information for individual patients that is recorded on this recording medium is read out on subsequent occasions when living-body information is to be acquired by these patients, and (for example) when diagnoses are made by physicians or when judgements are made by the patients themselves.
DISCLOSURE OF THE INVENTION
However, in the case of such prior art, the measurement conditions fluctuate according to the positional relationship between the measurement site and the photo-detector, so that the problem of measurement error arises.
Specifically, since the distribution of components in the living body is not uniform, the light path at the measurement site shifts (for example) if there is any shift in the mounting position of the photo-detector with respect to the measurement site, or any shift in the set position of the measurement site with respect to the device in which the photo-detector is mounted, so that the information contained in the light that is emitted from the living body fluctuates, thus resulting in the occurrence of measurement error. Furthermore, in cases where measurements are performed with the photo-detector pressed against the measurement site, there is a variation in the manner of flow of subcutaneous blood as a result of fine differences in the pressing force, in addition to a variation in the light path length accompanying shape deformation of the measurement site; as a result, the variation in measurements is increased, so that measurement error occurs.
Furthermore, since living-body information for numerous patients is recorded on the recording medium installed in a conventional measuring device, living-body information for individual patients may be erroneously acquired. In cases where living-body information for individual patients is thus erroneously acquired, this may lead to (for example) erroneous diagnoses by physicians or erroneous judgements by the patients themselves.
When living-body information is acquired by patients on subsequent occasions, and (for example) when diagnoses are made by physicians or when judgements are made by the patients themselves, the living-body information that is recorded on the recording medium installed in the measuring device must be read out. Accordingly, the same measuring device must be used, so that the convenience to the patients is poor.
It would appear that these problems are becoming more conspicuous as a result of the increasing commonness of living-body measurements for multiple numbers of patients in the household with the development of an increasingly aging society in recent years.
The present invention was devised in order to solve such problems. It is an object of the present invention to provide a noninvasive optical bioinstrumentation device which allows highly precise quantitative measurements of components in the living body. Furthermore, it is also an object of the present invention to provide a measurement site holder used in such an apparatus, which prevents erroneous diagnoses and erroneous judgements, and which offers increased convenience to the user.
The noninvasive living body optical measuring device of the present invention is a noninvasive optical bioinstrumentation device in which a specified measurement site in the living body is illuminated with light, the light that is transmitted through this measurement site or the light that is scattered and reflected by this measurement site is detected by a photo-detection system, and the concentrations of components in the living body are measured from this detected light, this device being wherein the device is equipped with a measurement site holder which is constructed using a negative impression of the measurement site, and in which the measurement site is placed at the time of light detection.
In a noninvasive optical bioinstrumentation device constructed as described above, the measurement site holder is constructed using a negative impression of the measurement site; accordingly, this measurement site holder can be caused to fit or conform to the shape of the patient's measurement site. Accordingly, the measurement site can be positioned with good precision when the measurement site is placed in the measurement site holder at the time of light detection, so that shifts in the light path at the measurement site are reduced compared to those in a conventional device. Consequently, variations in the measured values caused by the non-uniform distribution of components in the living body are reduced, and variations in the shape of the measurement site are reduced compared to those seen in conventional devices, so that variations in the measured values caused by variations in the light path length accompanying changes in the shape of the measurement site, or by variations in blood flow due to differences in the contact pressure or the like, can be reduced.
Here, if the measurement site holder has a detachable structure, then the same device can be used in common by numerous patients, by selecting a measurement site holder that fits or conforms to the shape of the patient's measurement site, and mounting this measurement site holder on the device.
Furthermore, if the measurement site holder is manufactured as a negative impression of the measurement site for each individual patient, then this measurement site holder will conform to the shape of the measurement site, so that variation in the measured values can be minimized.
Furthermore, if the measurement site holder is equipped with an opening part that allows the illumination of the measurement site with light, and an opening part that makes it possible to guide the transmitted light or scattered and reflected light from the measurement site into the photo-detection system, or if the m
Hashimoto Seiichiro
Mizuno Toshihiko
Morita Nobuhiro
Sakamoto Shigeru
Sato Katsuhiko
Hamamatsu Photonics K.K.
Morgan & Lewis & Bockius, LLP
Winakur Eric F.
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