WO2012096102A1

WO2012096102A1 - Probe, optical measurement system, provision method, and packaged article for diagnosis purposes

Info

Publication number: WO2012096102A1
Application number: PCT/JP2011/079334
Authority: WO
Inventors: 祥一田尾; 桂田　弘之; 岩坂　喜久男; 夏野　靖幸; 篤澤田; 新　勇一
Original assignee: コニカミノルタオプト株式会社
Priority date: 2011-01-14
Filing date: 2011-12-19
Publication date: 2012-07-19
Also published as: JPWO2012096102A1; JP5915543B2

Abstract

The purpose of the present invention is to provide a unit for establishing a measurement environment for correction purposes, which can provide a known optical environment to a probe tip during a measurement for correction purposes, whereby it becomes possible to provide the optical environment steadily without making the handling of the unit complicated. A probe (10) is equipped with a tip part (11) which comprises a light-receiving optical system involving an optical fiber or an imaging element and is provided at one end of the probe and a connector part (12) which is to be connected to a base unit (20) equipped with a detector and is provided at the other end of the probe, wherein a unit (40) for establishing a measurement-environment for correction purposes is provided in the connector part. The unit for establishing a measurement-environment for correction purposes constitutes an optical-environment-retaining chamber (42) having an opening (41) to which the tip part is to be inserted, and a known optical environment is applied to the tip part by inserting the tip part to the optical-environment-retaining chamber through the opening. A packaged article for diagnosis purposes comprises a tray, a probe accommodated in the tray, an adjusting jig equipped with a correction target, and a packaging bag in which the aforementioned components are accommodated.

Description

Probe, optical measurement system, providing method, and diagnostic package

The present invention relates to a probe for measuring an emitted light having an optical system for irradiating a measurement target site of a living tissue with irradiation light and receiving the emitted light emitted from the measurement target site.

Conventionally, a special diagnostic probe that irradiates a measurement target site of biological tissue with irradiation light such as excitation light and detects emitted light such as fluorescence generated from a biological tissue or a drug that has been previously injected into the biological body by this irradiation light. Has been developed and is used for diagnosis of disease states (eg, disease type and infiltration range) such as degeneration of living tissue and cancer.
In such a probe, an optical fiber, a lens, a light guide for guiding the irradiation light from the light source device, irradiating the measurement target site of the living body and receiving the radiated light emitted from the lesioned part, and guiding it to the detector, An optical system such as a prism is configured.

In order to make a diagnosis by an accurate optical measurement using such a probe, it is necessary to appropriately perform necessary corrections among the following several types of corrections.

First, as the first type of correction, it is required to correct variations in light intensity and detection sensitivity for each wavelength due to a combination of a probe, a light source, and a detector. As a method for that purpose, the setting contents of the apparatus related to the optical characteristics are set so that the measurement target is a substance with known optical characteristics such as reflectance spectrum, emission spectrum and Raman scattering spectrum, and the obtained result corresponds to the known optical characteristics. In general, correction is performed by changing a variable in a calculation process for processing a detection signal of a detector or a calculation process content.
When performing this measurement, it is necessary to accurately detect the optical response of the measurement target, so it is necessary to prevent room light or the like from entering the detector as stray light.

As a second type of correction, for example, when reflected light or light emission derived from the internal configuration of the probe, such as reflected light or light emission from a lens or an optical fiber end face, is incident on the detector, It is also necessary to distinguish between light emitted from and stray light derived from the internal structure. For this purpose, it is effective to previously acquire the intensity spectrum of stray light derived from the internal structure in advance.
In this case, it is necessary to prevent stray light such as room light, and to prevent light emitted from the probe from being reflected or diffused from a substance other than the probe, or light emitted from a substance other than the probe from entering the probe. .

As a third type of correction, when a mechanism for amplifying the output of the detector and a mechanism for adjusting the amount of light incident on the detector are provided integrally or separately from the detector, the probe, light source, and detector Measure substances with known reflectivity and luminous efficiency in order to adjust the detector gain and transmittance of the neutral density filter appropriately according to fluctuations in detected light intensity due to variations in light intensity and detection sensitivity for each wavelength. It is effective to set the gain of the detector and the transmittance of the neutral density filter so that the obtained result becomes an appropriate value compared with the dynamic range of the detector.

As a fourth type of correction, if any of the light source, the detector, and the mechanism that optically connects the probe and the probe is movably installed, the light receiving amount of the detector is monitored and optimized. As described above, it is effective to adjust each movable part to ensure an appropriate amount of received light.

In addition to these corrections, the same configurations as those of the first and second types of correction are used, but there is no need to measure the spectrum shape, and only the light intensity is measured, and accordingly, an apparatus related to the optical characteristics. In some cases, the correction is performed by changing the setting contents or the calculation processing contents for processing the detection signal of the detector. These cases can be regarded as derived from the first and second types of correction measurements, respectively.

The above correction measurement is not only used for calibration of the apparatus and correction of the obtained results, but can also be used for the purpose of determining deterioration or failure of the apparatus over time.

As described above, a probe that performs in-vivo diagnosis by optical measurement needs to perform one or more types of correction as described above. In particular, it is desirable that the probe can be easily performed under room illumination, not in a special environment such as a dark room. Such work is performed at a stage prior to treatment, but there is a demand to avoid as much as possible the compulsory, complicated, and troublesome work of the worker in the medical field.

Patent Document 1 describes an endoscope color balance adjuster. This endoscope color balance adjuster has an opening communicating with the internal space into which the distal end of the endoscope can be inserted at one end and a closed structure at the other end, and is a tube that blocks light from the outside. An inner member (103c in the same document) provided substantially parallel to the insertion axis of the distal end portion of the endoscope and the distal end portion of the endoscope are inserted into the inner surface of the tubular body. And an end face member (102c in the same document) provided so as to fall within the field of view of the objective lens, the inner member has a light absorption surface that absorbs light, and the end face member 102c is fluorescent light that emits fluorescence. Has a generating surface.
Patent Document 2 describes a color adjustment jig for an endoscope. As the color adjusting jig, a jig having a columnar shape, a first opening formed at one end of the jig, and a second opening formed at the other end of the jig, A hollow portion that penetrates the first opening and the second opening and into which the distal end portion of the color scope of the electronic endoscope can be inserted, and a lid that is movably supported in the vicinity of the second opening. The lid has a white balance adjustment chart on one side and a color adjustment chart on the other side, and either the white balance adjustment chart or the color adjustment chart is hollowed by the movement of the lid. It is possible to observe from the first opening through the part, and the movement of the lid is proposed by the rotation about the rotation axis that is pivotally supported by the second opening through the center of the lid. Yes.

JP 2006-223591 A JP 2005-40210 A

Endoscopes (electronic endoscopes) are widely used as devices for observation and optical measurement in the body, and are expensive devices that are generally used for a long period of time. Conventional techniques such as those described above are known as calibration means for image quality calibration / correction.
However, generally used electronic endoscopes aim to improve the contrast between a lesioned part and a normal part by an optical method, and the degree of progression of the lesion is judged by an observer. In order to determine the degree of progression of a lesion by optical measurement, the necessity of correcting the detection characteristics of the apparatus is higher than that of a widely used electronic endoscope. Contamination of the measurement object or deterioration with time during the correction work may deteriorate the correction accuracy and lead to a misjudgment.
In the medical field, there is a problem of contamination with body fluids such as blood. In the method of installing or incorporating a correction measurement target in a part where the frequency of cleaning is low, such as an endoscope processor, the operator needs to periodically clean and wash the correction measurement target, which complicates complicated and troublesome work. It will be. In addition, since it is left to the operator to manage the degree of cleaning of the measurement object for correction, it is difficult to prevent inappropriate correction work by the operator.
In a configuration in which a correction cap as described in

Patent Documents

1 and 2 is attached, if the cap is small, there may be a problem of contamination or loss due to dropping on the floor, and the size is such that it can be easily handled. Is required. Further, in the case of a probe to be used repeatedly, the point that cleaning or replacement is still necessary remains unchanged.

The present invention has been made in view of the above problems in the prior art, and includes an optical system for receiving irradiation light emitted from a measurement target site by irradiating the measurement target site of biological tissue with irradiation light. In providing a measurement environment component for correction (adjustment jig) that gives a known optical environment to the probe tip during measurement for correction to an optical measurement system using a probe for measuring the emitted light. It is an object of the present invention to stably provide the optical environment without incurring complicated handling of the correction measurement environment component.

The invention according to claim 1 for solving the above-described problem is provided with an optical system for receiving radiation light emitted from the measurement target part by irradiating the measurement target part of the living tissue with the irradiation light. A probe for measuring light,
At one end, it has a connector part connected to a base unit having a detector, at the other end, a tip part in which a light receiving optical system including at least an optical fiber or an image sensor is configured,
An optical environment holding chamber having an opening portion into which the tip portion is inserted is configured, and the tip portion is inserted into the optical environment holding chamber from the opening portion, so that the tip portion has a known optical environment. A correction measurement environment component for providing an environment is a probe provided in the connector portion.

The invention according to claim 2 is characterized in that the measurement environment component for correction has a light shielding member that blocks external light from entering the optical environment in a state where at least the tip portion is inserted. The probe according to Item 1.

The invention according to claim 3 is the probe according to

claim

1 or 2, wherein the measurement environment component for correction has a predetermined measurement target substance in the optical environment holding chamber.

The invention according to claim 4 is characterized in that a locking structure for restricting further insertion of the tip portion inserted into the correction measurement environment component with a predetermined insertion length is configured. It is a probe as described in any one of Claim 3.

According to a fifth aspect of the present invention, there is provided a locking structure that restricts further insertion of the tip portion inserted into the measurement environment component for correction with a predetermined insertion length with a predetermined locking force and prevents the tip portion from being pulled out. The probe according to any one of claims 1 to 3, wherein the probe is formed.

The invention according to claim 6 is characterized in that a mark for displaying a length from the tip corresponding to the insertion length to be applied at the time of correction measurement is provided on the outer periphery of the tip. The probe according to any one of Items 5.

Invention of Claim 7 is an optical measurement system provided with the probe as described in any one of Claims 1-6, and the base unit to which the said connector part of the said probe is connected,
The base unit is
A light source device for the irradiation light;
A detector for detecting the light intensity of the emitted light;
The measurement result for correction measured in the optical environment by the measurement environment component for correction is stored and stored, and the measurement result of the living tissue for the living tissue is determined based on the measurement result for correction in accordance with a predetermined algorithm. An optical measurement system having an arithmetic processing unit that corrects the above.

Invention of Claim 8 is an optical measurement system provided with the probe as described in any one of Claims 1-6, and the base unit to which the said connector part of the said probe is connected,
The base unit is
A light source device for the irradiation light;
A detector for detecting the light intensity of the emitted light;
The measurement result for correction measured in the optical environment by the measurement environment component for correction is stored and stored, and based on the measurement result for correction, the gain of the detector or the attenuation filter is determined according to a predetermined algorithm. An optical measurement system having an arithmetic processing unit for setting a transmittance.

Invention of Claim 9 is an optical measurement system provided with the probe as described in any one of Claims 1-6, and the base unit to which the said connector part of the said probe is connected,
The base unit is
A light source device for the irradiation light;
A detector for detecting the light intensity of the emitted light;
The measurement result for correction measured in the optical environment by the measurement environment component for correction is stored and stored, and based on the measurement result for correction, the light source device, the detector, or them according to a predetermined algorithm And an arithmetic processing unit that movably adjusts at least one movable part of the mechanism for optically connecting the probe.

The invention according to claim 10 has a mechanical structure in which the connector portion is allowed to be connected to the base unit only in a certain orientation, and the tip portion is connected in the state where the connector portion is connected to the base unit. 10. The correction measurement environment component is configured such that the insertion direction of the portion into the correction measurement environment component is regulated vertically downward or obliquely downward. This is an optical measurement system.

The invention according to claim 11 is a method for providing a user of the probe according to any one of claims 1 to 6, comprising:
A sterilization step of sterilizing the probe including the correction measurement environment component;
And a packaging process for packaging the probe in the same package including the correction measurement environment component.

The invention according to claim 12 is a tray,
A probe housed in the tray for transmitting, projecting and receiving light;
A calibration target that is irradiated with light emitted from the probe during calibration of the probe, holding the probe during calibration of the probe, and an adjustment jig housed in the tray;
A diagnostic package comprising the probe, the adjustment jig, and a packaging bag enclosing the tray.

According to a thirteenth aspect of the present invention, the tray includes a tray main body, a probe storage recess recessed in the upper surface of the tray main body, and an adjustment jig storage recess recessed in the upper surface of the tray main body. And
The diagnostic packaging according to claim 12, wherein the probe is stored in the probe storage recess, and the adjustment jig is stored in the adjustment jig storage recess.

The invention according to claim 14 is characterized in that the probe storage recess is a ring-shaped cable storage portion recessed in the upper surface of the tray main body, and is recessed in the upper surface of the tray main body, connected to the cable storage portion, A connector storage portion extending from the cable storage portion in the tangential direction of the cable storage portion, and recessed in the upper surface of the tray body, connected to the cable storage portion, and extending from the cable storage portion in the tangential direction of the cable storage portion. A distal end storage portion,
The probe is connected to a cable main body for transmitting light, a connector for inputting / outputting light, and connected to a distal end of the cable main body for light projection and light reception. A light receiving and receiving unit,
The diagnostic packaging according to claim 13, wherein the light projecting / receiving unit is stored in the tip storage unit, the cable body unit is stored in the cable storage unit, and the connector is stored in a connector storage unit. It is.

The invention according to claim 15 is the diagnostic packaging according to claim 14, wherein the cable main body is wound and stored in the cable storage.

The invention according to claim 16 is the diagnostic package according to claim 15, wherein the cable main body is spirally wound so that the connector side overlaps the light projecting / receiving portion side.

The invention according to claim 17 is the diagnostic package according to claim 15, wherein the cable body is spirally wound so that the light projecting / receiving part side overlaps the connector side.

The invention according to claim 18 is characterized in that the adjustment jig includes a jig body housed in the adjustment jig housing recess, an insertion opening opened on a surface of the jig body, and the jig body from the insertion opening. An insertion hole extending in the interior of
The diagnostic packaging according to any one of claims 13 to 17, wherein the calibration target is disposed in the insertion hole.

The invention according to claim 19 is the diagnostic package according to claim 18, wherein the insertion hole is closed on the opposite side of the insertion port.

The invention according to claim 20 is characterized in that the adjustment jig further has a stopper protruding from the inner wall of the insertion hole,
20. The diagnostic package according to claim 18 or 19, wherein the calibration target is disposed in the insertion hole on the opposite side of the insertion port with respect to the stopper.

The invention according to claim 21 is characterized in that the jig body of the adjustment jig is housed in the jig housing recess with the insertion port facing obliquely upward. The diagnostic packaging according to any one of the above.

The invention according to claim 22 is the diagnostic package according to any one of claims 18 to 21, wherein the adjustment jig further includes a light shielding sheet attached to the inner wall of the insertion hole. It is.

23. The invention according to claim 23, wherein the adjustment jig further includes a flexible tube attached to the jig body so as to communicate with the insertion hole through the insertion port. The diagnostic packaging according to any one of the above.

The invention according to claim 24 is the invention from claim 18, wherein the insertion port, the insertion hole, and the number of calibration targets are plural, and the calibration target is disposed in the insertion hole. 24. The diagnostic package according to any one of items 23.

The invention according to claim 25 is the diagnostic packaging according to claim 24, wherein the color is different for each calibration target.

The invention according to claim 26 is the diagnostic device according to claim 24 or 25, wherein the color of any one of the calibration targets is white and the color of any other calibration target is black. It is a package.

According to the probe of the present invention, since the measurement measurement environment component for correction is provided in the connector portion of the probe, one or more measurement environment components for correction can always be provided for one probe, and before the probe is used. Only the correction measurement environment component cannot be lost alone during the correction measurement as preparation, and there is an effect that the correction measurement environment component is not lost.
Further, according to the probe of the present invention, since the measurement environment component for correction is provided integrally with the probe, the troublesome handling and management when the measurement environment component for correction is separate from the probe is drastically eliminated. There is an effect that.
When the probe of the present invention is used repeatedly, the probe is cleaned every time it is used, and the correction measurement environment components are simultaneously cleaned by cleaning the probe. There is no need to clean the components, and it is possible to always perform correction measurements that match the intention of the provider only by periodic replacement.
In addition, when the probe of the present invention is used as a disposable specification, the entire clean probe including the measurement environment component for correction is provided, and the user is concerned about the deterioration over time of the measurement environment component for correction and its storage environment. There is no need to consider it, and there is an effect that it is possible to always perform correction measurement that matches the intention of the provider.

On the other hand, according to the diagnostic packaging of the present invention, since the probe and the adjustment jig are bundled and wrapped in the packaging bag, there is no need to prepare a large-scale adjustment jig different from the adjustment jig. You can do it.
Further, when the user opens the packaging bag, the user notices the presence of the adjusting jig. Therefore, the user must remember to perform calibration using the adjustment jig before making a diagnosis using the probe.
Further, since the probe and the adjustment jig are bundled and wrapped in the packaging bag, the new adjustment jig can be used for calibration. Therefore, there is almost no secular change of the calibration target, and accurate calibration can be performed.

Therefore, the application of the present invention can stably give the optical environment at the time of the correction measurement to the probe while greatly reducing the management burden on the user, and the correction measurement intended by the provider is ensured. There is an effect that it is executed.

It is a perspective view which shows the accommodation state of the probe which concerns on one Embodiment of this invention. It is a perspective view which shows the connection state of the probe which concerns on one Embodiment of this invention. It is a side view schematic diagram which shows an example of the basic composition of a probe. It is a side view schematic diagram which shows another example of the basic composition of a probe. It is a side view schematic diagram which shows another example of the basic composition of a probe. It is a side view schematic diagram which shows another example of the basic composition of a probe. It is a side view schematic diagram which shows another example of the basic composition of a probe. It is a figure which shows the cross section which concerns on an example of the measurement environment component for correction | amendment which concerns on one Embodiment of this invention, and the side surface of a probe. It is a figure which shows the cross section and side surface of a probe which concern on the other example of the measurement environment component for a correction | amendment which concerns on one Embodiment of this invention. It is a figure which shows the cross section and side surface of a probe which concern on the other example of the measurement environment component for a correction | amendment which concerns on one Embodiment of this invention. It is a perspective view of the connector part of the probe concerning one embodiment of the present invention. It is a perspective view of the connector part of the probe concerning one embodiment of the present invention. It is a perspective view of the connector part of the probe concerning one embodiment of the present invention. It is a perspective view of the connector part of the probe concerning one embodiment of the present invention. It is a development state perspective view of the constituent member concerning an example of the measurement environment constituent for amendment. It is a perspective view at the time of the assembly of the structural member which concerns on an example of the measurement environment component for correction | amendment. It is a perspective view of a connector part of a constituent member after an assembly concerning an example of a measurement environment constituent for amendment, and an embodiment of the present invention. It is a perspective view of the connector part of the probe concerning one embodiment of the present invention. It is a perspective view of the connector part of the probe concerning one embodiment of the present invention. It is a figure which shows the cross section and side surface of a probe which concern on the other example of the measurement environment component for a correction | amendment which concerns on one Embodiment of this invention. It is a figure which shows the cross section and side surface of a probe which concern on the other example of the measurement environment component for a correction | amendment which concerns on one Embodiment of this invention. It is an external appearance perspective view of the diagnostic packaging which concerns on other embodiment of this invention. It is a disassembled perspective view of the diagnostic packaging which concerns on other embodiment of this invention. It is a top view of the probe concerning other embodiments of the present invention. It is a disassembled perspective view of the adjustment jig which concerns on other embodiment of this invention. It is sectional drawing of the adjustment jig which concerns on other embodiment of this invention. FIG. 6 is a partial cross-sectional view of a tray according to another embodiment of the present invention. It is a disassembled perspective view of the diagnostic packaging which concerns on other embodiment of this invention. It is a perspective view of the base unit which concerns on other embodiment of this invention. It is a block diagram of the base unit which concerns on other embodiment of this invention. It is the perspective view which showed the use condition of the diagnostic packaging which concerns on other embodiment of this invention. It is the flowchart which showed the flow of the process performed by the computer of the base unit which concerns on other embodiment of this invention. It is a disassembled perspective view of the adjustment jig which concerns on a modification. It is sectional drawing of the adjustment jig which concerns on a modification.

<Embodiment of a probe in which a measurement environment component for correction is provided in a connector>
An embodiment of the present invention will be described below with reference to FIGS. 1 to 12B. The following is one embodiment of the present invention and does not limit the present invention. In the following embodiments, a fluorescence measurement probe will be described as an example.

FIG. 1 shows a probe 10 of this embodiment and a packaging tray 30. 1 and 2 show the main part of the optical measurement system 1 of the present embodiment. The optical measurement system 1 includes an image display device and an operation input device in addition to the probe 10 and the base unit 20.
The probe 10 includes a distal end portion 11, a connector portion 12, and a cable portion 13.
As shown in FIG. 1, the probe 10 is sterilized and stored in a packaging tray 30. Further, the probe 10 is sealed and packaged by a packaging bag (not shown), and is provided to a user such as a medical site.
The user unwraps and connects the connector portion 12 of the probe 10 to the connection portion 21 of the base unit 20 as shown in FIG. Then, after the measurement for correction is performed in a state where the distal end portion 11 is inserted into the measurement environment component for correction 40 provided in the connector unit 12 by the user, the probe 10 is used for measurement of the living tissue. Can do.
The base unit 20 includes a light source device for irradiation light, a detector for detecting the light intensity of emitted light from a living tissue or the like, and an arithmetic processing device. Here, the arithmetic processing device may be provided separately from the base unit, and both may be electrically connected.

[Example of basic configuration of probe]
Here, a basic configuration example of the probe will be described.
A probe for performing in-vivo diagnosis by optical measurement has an optical system in which one end thereof is inserted into the body, and the biological tissue is irradiated with light and reflected by the biological tissue or emitted from the biological tissue. The other end is configured to have a mechanism connected to a device (base unit 20 in the present embodiment) having a light source device and a detector.
The probe has one or more optical fibers for guiding excitation light for optical measurement and light emitted from living tissue. 3A to 3E show the layout of the optical system. Actually, these optical systems are fixed by a holder, an exterior, or the like to form a probe. The simplest optical system configured in the probe is composed of one light guide optical fiber 14a shown in FIG. 3A. In addition to this, an optical element such as a lens or a prism may be provided. Specifically, as shown in FIGS. 3E and 3B, a structure in which a lens 15 is inserted at the tip of the fiber in order to increase the light collection efficiency, or the light traveling direction is changed as shown in FIG. The optical component 16 that is a prism or a mirror is inserted in order to observe and measure the biological tissue 50 that is substantially parallel to the body. As shown in FIG. 3C, a probe that emits light in a direction perpendicular to the axis of the light guide optical fiber 14d is generally provided with an optical component 16 that is a prism or a mirror at the tip of the light guide optical fiber 14d. A method of changing the traveling direction by reflecting is applied. Here, the shape of the reflection surface of the optical component 16 that is a prism or a mirror is generally a plane, a paraboloid, and a spherical surface, but is not limited thereto.
Further, as shown in FIG. 3B, the function is shared between the irradiation light guiding optical fiber 14b for irradiating the living tissue 50 with the irradiation light and the signal light guiding optical fiber 14c for receiving the radiated light from the living tissue 50. As described above, a configuration using a plurality of light guiding

optical fibers

14e, 14f, 14g,... May be employed for the purpose of increasing the measurement area or increasing the light collection efficiency or the light collection amount.

In general, such probes are broadly classified into those that measure a certain point in living tissue in one measurement and those that measure a plurality of points at the same time, but in this embodiment, the two are not distinguished. It explains according to. Typical typical probe configurations are as shown in FIGS. 3A to 3E.
The proximal end side of the probe has a mechanism for connecting and fixing the above-described optical fiber to a device having a light source device and a detector. For example, a mechanism for connecting ordinary optical fibers such as SMA, FC, ST, LC, and SC is used, but is not limited thereto. When there are a plurality of optical fibers and there are a plurality of connectors, the individual connectors are installed and fixed in a case or cover, and the whole corresponds to the connector section 12 shown in FIGS. Become. In this case, the measurement environment component for correction can be installed either in the case where the material is filled therein or in the case where the space is not filled.
Since the entire probe is provided to the user in a sterilized state, the material used is selected to withstand the required sterilization operation.

[Configuration example and installation example of correction measurement environment components]
4A to 4C show configuration examples 40A, 40B, and 40C of the correction measurement environment component 40. FIG.
The correction measurement environment component 40 is configured to hold and fix at least one of the measurement target substance for correction measurement and the light shielding member in the measurement range of the distal end portion 11 of the probe 10. The correction measurement environment component 40 has one of the following configurations in order to ensure light shielding properties.
That is, the correction measurement environment component 40 has an opening 41 into which the tip 11 of the probe 10 is inserted, and an optical environment holding chamber that forms a closed space when the tip 11 of the probe 10 is inserted. 42, and a measurement target substance (43 in FIG. 4A or 44 in FIG. 4B) is installed in the optical environment holding chamber 42, or the optical environment holding chamber is formed by the measurement target substance itself as shown in FIG. 4C. Either of the wall portions 45 constituting 42 is formed.
In the latter case, for example, the wall 45 constituting the optical environment holding chamber 42 is formed of white resin, and the reflected light from the inner surface of the wall 45 is measured to obtain the spectral shape of the irradiation light itself. be able to. At this time, if the room illumination light passes through the wall portion 45 and enters the distal end portion 11 of the probe 10, it becomes stray light and cannot be corrected appropriately. Therefore, it is necessary for the wall 45 to have a thickness sufficient to provide a light shielding property.
In both cases, the optical environment holding chamber 42 of the correction measurement environment component 40 is configured (43, 46, 48 in FIG. 4A, 44, 47, 48 in FIG. 4B, 45, 48 in FIG. 4C). Need not be made of the material to be measured, and the portion not irradiated with the emitted light of the probe 10 may be made of another material having sufficient light shielding properties.

When the correction measurement environment component 40 itself has a sufficient light-shielding property against external light intrusion into the optical environment holding chamber 42, the correction measurement environment component 40 is installed or built in. The case member which comprises the exterior of the connector part 12 may be the structure which does not have sufficient light-shielding property.
Further, even if the light shielding property of the correction measurement environment component 40 is poor, the case member constituting the exterior of the connector portion 12 in which the correction measurement environment component 40 is built has a sufficient light shielding property. If it is.
The degree of sufficient light shielding described here is determined by the performance of the optical measurement system (the light amount of the light source and the ratio of the detected light amount to the irradiation light amount) and the brightness of the indoor lighting in the usage environment. Therefore, it is not always necessary to perform the measurement that the inside of the optical environment holding chamber 42 in which the probe is inserted is kept light-tight. However, for the purpose of realizing accurate correction measurement regardless of the operator or the usage environment, it is desirable to provide a configuration that is kept light tight by simply inserting the tip 11 of the probe 10.

Whether such a measurement environment component for correction 40 is installed outside the connector unit 12 as shown in FIGS. 5 and 11 or inside the connector unit 12 as shown in FIGS. With either structure, the connector unit 12 and the correction measurement environment component 40 are integrated.
As shown in FIGS. 5 to 11, the insertion direction of the tip portion 11 of the probe 10 may take any direction with respect to the insertion direction C of the connector portion 12, and a plurality of correction measurement environment components 40 may be used. , 40..., 40... May be common as shown in FIGS. 6, 7 and 11, or may be different as shown in FIG.
However, in order to prevent the distal end portion 11 of the probe 10 inserted into the measurement environment component for correction 40 from being pulled out by its own weight, the connector unit 12 is allowed to be connected to the base unit 20 only in a certain orientation. For example, it has a mechanical structure such as a protrusion / groove for reducing the symmetry of the connector cross-sectional shape and an asymmetrical connector cross-sectional shape, and in the state where the connector portion 12 is connected to the base unit 20, the tip portion 11 It is preferable that the correction measurement environment component 40 is configured in the connector unit 12 so as to restrict the insertion direction to the correction measurement environment component 40 to be vertically downward or obliquely downward. For example, as shown in FIG. 2, the mechanical structure that is allowed to be connected to the base unit 20 only in the orientation with the surface 12 a of the connector portion 12 facing up is constituted by the connector portion 12 and the connection portion 21 of the base unit 20. In such a case, the arrangement of the measurement environment component for correction 40 shown in FIGS. 5, 6, and 10 is preferable. In the configuration shown in FIGS. 5 and 6, the insertion direction of the distal end portion 11 into the correction measurement environment component 40 is regulated to be vertically downward. In the configuration shown in FIG. 10, the insertion direction of the distal end portion 11 into the correction measurement environment component 40 is restricted obliquely downward.

接着 Adhesion, fitting, integral molding, screwing, and the like are applied to fix the connector portion 12 and the correction measurement environment component 40, but are not limited thereto. When a plurality of types of correction measurements are required, a plurality of correction measurement environment components 40 corresponding to the required types are prepared and similarly installed either outside or inside the connector unit 12.

The shape of the optical environment holding chamber 42 partitioned by the wall portion of the correction measurement environment component 40 is a shape composed of a plane such as a rectangular parallelepiped, a shape composed of a plane and a curved surface such as a cylinder, and a curved surface such as a sphere. Any of the shapes can be selected.
As the measurement object for correction, in the first type of correction described above, a standard color chart (color chart) such as a Munsell color sheet having known optical characteristics, an appropriate fluorescent standard, and a Raman standard sample are used. Depending on the light emission direction of the probe 10, the measurement target substance (43 or 44) is located at the position facing the tip 11 of the probe 10 as shown in FIG. 4A, or the tip 11 as shown in FIG. It is arranged at a position that surrounds. Since these measurement target substances (43 and 44) are integrated with the probe, it is required to withstand each sterilization process.

The optical environment holding chamber 42 is molded either by molding integrally with the outer case of the connector part 12 or by molding alone. Therefore, it is possible to use a material different from the material used for the outer case of the connector portion 12, and a material having an appropriate light shielding property and reflectance can be selected.

The opening 41 for inserting the distal end portion 11 of the probe 10 is required to have the functionality of ensuring light shielding and positioning and fixing the probe 10. In order to ensure the light shielding property, an opening having the same diameter as the probe outer diameter or an elastic light shielding member 48 such as maltoprene is fixed to the inner periphery of the opening 41 as shown in FIGS. 4A to 4C. Thus, it is possible to obtain an appropriate insertion aperture and probe holding property, and to secure the light shielding property of the optical environment holding chamber 42 in which the tip portion 11 is inserted.
9A to 9C show an assembly example of the correction measurement environment component 40. FIG. As shown in FIG. 9A, an elastic light-shielding member 62 such as maltoprene is attached to the member 61 composed of a rectangular portion 61a and a circular portion 61b connected to one side thereof in the vicinity of the opposite side along the opposite side of the one side. To do. As shown in FIG. 9B, this is assembled by winding so that the one side and the circumference of the circular portion 61b are aligned. The bottomed cylindrical structure 60 thus formed is inserted into the hole 12b provided in the connector portion 12 as shown in FIG. 9C, thereby installing the correction measurement environment component in the connector portion 12. Such assembly examples may also be applied to the configurations shown in FIGS. 5 to 8, 10 and 11.

12A and 12B show other configuration examples 40D and 40E of the correction measurement environment component 40. FIG. In order to position and fix the probe 10, as shown in FIGS. 12A and 12B, it is desirable that

projections

49 and 51 for positioning the distal end portion 11 of the probe 10 are provided. Unlike other members, the mechanism for positioning does not necessarily have a light shielding property. In addition, in order to fix the angle of the central axis of the probe 10 or to improve the light shielding property of the opening, it is desirable to have a sufficient insertion portion length.
In the configuration shown in FIG. 12A, the locking structure for restricting further insertion of the distal end portion 11 inserted into the correction measurement environment constituent 40D with a predetermined insertion length L is provided on the distal end surface of the distal end portion 11 and the protrusion. Part 49.
In the configuration shown in FIG. 12B, the distal end portion 11 inserted into the measurement environment component for correction 40E is locked with a predetermined insertion length L with a predetermined locking force to restrict further insertion and prevent extraction. The structure is constituted by the outer peripheral groove 52 and the protrusion 51 of the tip 11.
A mark 53 (see FIG. 12B) for displaying the length from the distal end corresponding to the insertion length L to be applied at the time of the correction measurement is used in place of the above locking structure or together with the above locking structure. The configuration provided in is also effective. By using the mark 53, the user can confirm whether or not the insertion length of the distal end portion 11 is appropriate.

By the way, when light is emitted from the light guide optical fiber 14, the light is reflected and diffused at the fiber end face, the light passing portion of the lens 15, the optical component 16, and the outer tube 17, and a part of the light enters the light guide optical fiber 14. .
As described above, in the second type of correction, measurement is performed so that the spectral intensity of stray light derived from the internal configuration of these probes 10 is extracted alone. Therefore, it is necessary to configure the correction measurement environment component 40 so that the light emitted from the probe 10 to the optical environment holding chamber 42 does not return to the probe 10 again.
Therefore, in the probe to which the second type of correction for measuring the spectral intensity of stray light derived from the internal configuration of the probe 10 is applied, the reflectance is sufficiently high as a material constituting the inner wall of the optical environment holding chamber 42. It is required to use a low material. This is to prevent the light emitted from the distal end portion 11 of the probe 10 from entering the distal end portion 11 again. In order to achieve this purpose more effectively, a material having a low reflectance is used, a space in the optical environment holding chamber 42 is increased, and the distance between the inner wall of the optical environment holding chamber 42 and the distal end portion 11 is increased. Is preferably ensured.

When a plurality of types of correction measurement environment components 40 are installed in the connector section 12, as shown in FIGS. 6 to 8, identification symbols (for example, numbers such as 1 and 2, etc., reflection, It is effective to clearly indicate the characters (e.g., light emission) on the case of the connector portion 12 by means such as molding, printing, or labeling.
Note that when performing correction measurement a plurality of times, the wavelength used for each measurement may be different.

By forming the measurement environment component for correction 40 as described above in the connector portion 12 of the probe 10, the following effects can be expected.
The connector portion 12 of the probe 10 is already large enough to be easily handled by the user for the original purpose of connecting to the base unit 20. Therefore, the possibility of contamination due to falling on the floor can be reduced as compared with the case where the correction measurement environment component is configured as a cap or the like independent of the probe. Moreover, since it is integrated with the probe, there is no risk of loss.
In particular, among probes that perform in-vivo diagnosis by measurement, probes that reach the inside of the body via the forceps channel of the endoscope have an outer diameter of 2.8 mm or less for the general forceps channel (channel) diameter. The opening diameter of the measurement configuration is about the same. However, such a small-diameter cap cannot be said to be easy to handle from the viewpoint of size and strength, and the cap itself must be enlarged in order to provide a cap that is easy to handle.
On the other hand, when the correction measurement environment component 40 is installed in the connector portion 12 of the probe 10, a slight external additional configuration is added to the connector portion that originally has a constant size, or the connector portion is internally provided. In this case, the correction measurement environment component 40 can be added without changing the size of the connector portion.

The probe 10 connector portion 12 is a part that is always operated and connected by the user when using the optical measurement system 1. Therefore, the correction measurement can be performed by writing a word or a drawing for prompting the correction measurement. It also has the effect of preventing you from forgetting to work.
In the present embodiment, a set of measurement environment components for correction 40 is reliably provided for one probe in a state where the entire probe is sterilized and packed in a sterilization bag. Therefore, in the case of a disposable or one-time use probe, the user does not need to consider the deterioration over time of the correction measurement target and its storage environment, and can always perform correction measurement that matches the intention of the provider. .
In the case of a probe that is used repeatedly, the probe is cleaned each time it is used, so that the user does not need to clean the measurement environment component 40 for correction separately, and the correction always matches the intention of the provider only by periodic replacement. Measurement can be performed.
In any case, since one or more correction measurement environment components 40 can be simultaneously provided for one probe 10, even if the design of the probe is changed, the correction measurement environment component is correspondingly changed. The design of 40 can be changed, and the measurement environment component 40 for correction suitable for a specific probe can be provided.

[Measurement procedure for correction]
Next, a correction measurement procedure using the correction measurement environment component 40 of the present embodiment will be described. In the following, a disposable probe that is used only once will be described.
When using the probe 10, the user first takes out the probe 10 from the sterilized package. Thereafter, the connector portion 12 of the probe 10 is connected to the base unit 20.
By providing detection means such as a switch or a sensor in the connection portion 21 of the base unit 20, the base unit 20 automatically detects that the probe 10 is connected, or that the operator has connected the probe 10. Is input to the base unit, and the correction measurement procedure is executed. Here, the present system 1 guides the correction measurement procedure to the user by at least one of voice and screen display.
The user inserts the distal end portion 11 of the probe 10 into the opening 41 of the correction measurement environment component 40 provided in the connector portion 12 according to the guidance. Thereafter, the user inputs a measurement start command to the base unit 20, and light from the light source device of the base unit 20 is guided to the fiber tip and emitted into the optical environment holding chamber 42. At this time, the signal light obtained by the probe 10 is input to the detector in the base unit 20.

When the signal light is input to the detector, the arithmetic processing device provided in the base unit 20 compares the obtained output value relating to the light amount and the spectral characteristics with values set in advance. Here, the arithmetic processing unit performs calculation of a correction coefficient for correcting the obtained data to be in an appropriate error range or correcting to an appropriate result. This is stored in a memory in the base unit 20 and used to correct the subsequent measurement result. That is, the arithmetic processing unit holds and stores the correction measurement result measured in the optical environment by the correction measurement environment component 40, and based on the correction measurement result, in accordance with a predetermined algorithm, the biological tissue An arithmetic process for correcting the biological measurement result for the target is executed.
Alternatively, when a mechanism for amplifying the output of the detector or a mechanism for adjusting the amount of light incident on the detector is provided integrally with or separately from the detector, the arithmetic processing unit relates to the obtained light amount and spectral characteristics. The output value is compared with a preset value, and the gain of the detector or the transmittance of the neutral density filter is changed to set the obtained data within an appropriate error range.
Alternatively, the arithmetic processing unit compares the obtained light quantity and output value related to the spectral characteristic with a preset value, and at least one of a light source, a detector, and a mechanism for optically connecting them to the probe. One movable part is movably adjusted so that the obtained data is within an appropriate error range.
In addition, when the output value at the time of the obtained correction measurement is greatly different from a preset value, the arithmetic processing unit notifies the user that the correction measurement has not been properly completed. Accordingly, the user performs measurement again or determines that the probe is defective, and prepares a new probe.
When performing a plurality of types of correction measurements, the system 1 pulls the probe 10 out to the user, clearly displays the identification symbol as described above, and inserts it into the opening 41 of another correction measurement environment component 40. Or prompt by voice display and move to the next correction measurement.
When all the correction measurements are completed, the present system 1 displays the completion of the correction measurement by image or sound, and the user inserts the distal end portion 11 of the probe 10 into the forceps channel of the endoscope and enters the body of the subject. Lead.

The probe of the present invention may be inserted into the body through a channel formed in the endoscope, or may be inserted into the body independently from the endoscope. It may be.

Fluorescence is broadly defined as an object irradiated with X-rays, ultraviolet rays, or visible light absorbs its energy, excites electrons, and releases excess energy as electromagnetic waves when it returns to the ground state. To do. Here, the excitation light (reference light) causes fluorescence having a wavelength different from that of the light to be generated as the return light. Therefore, the radiated light input in the detector is subjected to wavelength spectroscopy, and this is processed by the arithmetic processing unit as described above. And the amount of fluorescence generated is measured. The arithmetic processing unit performs data processing for recording the fluorescence measurement data in a data recording device or displaying it on an image display device. Also, data processing is performed to synthesize an image obtained by superimposing the surface image of the living tissue imaged by the endoscope and fluorescence measurement data, and this is recorded in a data recording device or displayed on an image display device. Data processing is performed.

In the above embodiments, the excitation light is irradiated to the measurement target site and the fluorescence generated due to the excitation light is received. However, reflected light, scattered light, Raman generated due to the irradiation light are described. Scattered light or harmonics due to nonlinear optical effects may be received. Even in these cases, it is possible to diagnose a disease state such as degeneration of a living tissue or cancer.
Also, an image pickup device is installed at the distal end portion 11, and the received signal light is converted into an electrical signal, which is transmitted from the distal end portion 11 to the probe proximal end and further to the detector of the base unit 20 through an electrical signal cable. Of course, it is possible to implement this method. In other words, what type of signal is used at which stage does not affect the implementation of the present invention.

<Embodiment of Diagnostic Package with Probe, Adjustment Jig, Tray, and Packaging Bag>
Hereinafter, embodiments for carrying out the present invention will be described with reference to FIGS. However, the embodiments described below are given various technically preferable limitations for carrying out the present invention, but the scope of the present invention is not limited to the following embodiments and illustrated examples. Moreover, the code | symbol used for FIGS. 13-25 is not common with the code | symbol used for FIGS. 1-12B.

[Outline of diagnostic packaging]
FIG. 13 is an external perspective view of the diagnostic packaging 1. FIG. 14 is an exploded perspective view of the diagnostic packaging 1. As shown in FIGS. 13 and 14, the diagnostic package 1 includes a probe 10, an adjustment jig 30, a tray 70, a cover 80, a packaging bag 90, and the like.

Probe 10 is a cable material that transmits, projects and receives light. The proximal end portion of the probe 10 is a connector 11 for inputting / outputting light, the distal end portion of the probe 10 is a light projecting / receiving portion 12 for projecting / receiving light, and an intermediate portion of the probe 10 is projected with the connector 11. This is a cable body 13 that transmits light between the light receivers 12. The light projecting / receiving unit 12 is connected to the distal end of the cable body 13, and the connector 11 is connected to the proximal end of the cable body 13.

When the probe 10 is used, the connector 11 is connected to the base unit 100 (shown in FIGS. 20 and 21; details of the base unit 100 will be described later), and the light projecting / receiving unit 12 is inserted into the lumen. Excitation light emitted from the light source of the base unit 100 is input to the connector 11 at the proximal end portion of the probe 10, and the input excitation light is transmitted to the light projecting / receiving portion 12 at the distal end portion by the cable body portion 13. The excited excitation light is irradiated from the light projecting / receiving unit 12 to the measurement site of the living tissue in the lumen. The measurement site emits fluorescence by excitation light. The fluorescence emitted from the measurement site is received by the light projecting / receiving unit 12, and the received fluorescence is transmitted to the connector 11 at the base end by the cable body 13, and the transmitted fluorescence is transmitted from the connector 11 to the base unit 100. Is output. The base unit 100 performs spectral analysis of the fluorescence input to the base unit 100. Using the probe 10 as described above, an optical diagnosis is performed by the probe 10.

This probe 10 is disposable. That is, from the viewpoint of hygiene, the probe 10 that is once inserted into the lumen is not reused.

The adjustment jig 30 is used before the probe 10 is inserted into the lumen and used. When the adjustment jig 30 is used, the light projecting / receiving portion 12 of the probe 10 is held by the adjustment jig 30 and the connector 11 of the probe 10 is connected to the base unit 100. Then, light of known standard intensity emitted from the light source of the base unit 100 is projected from a light projecting / receiving unit 12 of the probe 10 onto a part of the adjustment jig 30 (calibration target), and the reflected light thereof is projected and received. 12, and the received light is transmitted to the base unit 100 by the probe 10. In the base unit 100, the intensity of the input light is measured, and calibration is performed by taking into account the difference between the measured intensity and the known standard intensity.

〔probe〕
The probe 10 will be specifically described.
FIG. 15 is a plan view of the probe 10. As shown in FIG. 15, the probe 10 includes a light projecting optical fiber 14, a light receiving optical fiber 15, an illumination optical fiber 16, a lens 17, an illumination lens 18, a holder 19, a connector housing 21, a tube 25, and the like.

The tube 25 is provided in a tubular shape. The tube 25 forms the outer peripheral wall of the probe 10. The tube 25 has water barrier properties and flexibility. The connector housing 21 is connected to the proximal end of the tube 25, and the holder 19 is connected to the distal end of the tube 25.

The probe 10 has an identifier 26 attached thereto. The location to which the identifier 26 is attached is, for example, the connector housing 21, the tube 25, or the holder 19. The identifier 26 is, for example, an ID, a serial number, a manufacturing number, or a lot number.

The connection pins 22 to 24 are projected on the end face of the connector housing 21. The holder 19 has an internal space, and the internal space communicates with the hollow of the tube 25. A light projecting / receiving window 20 is provided on the front end surface of the holder 19. The lens 17 and the illumination lens 18 are accommodated in the internal space of the holder 19 and are fixed to the holder 19. The lens 17 faces the light projecting / receiving window 20 and the illumination lens 18 faces the light projecting / receiving window 20.

The light projecting optical fiber 14, the light receiving optical fiber 15, and the illumination optical fiber 16 are passed through the tube 25 from the connector housing 21 to the holder 19.
The proximal end portions of the light projecting optical fiber 14, the light receiving optical fiber 15, and the illumination optical fiber 16 are fixed to the connector housing 21 inside the connector housing 21. The portion near the base end of the light projecting optical fiber 14 is passed through the connection pin 22, and the base end of the light projecting optical fiber 14 is exposed at the protruding end of the connection pin 22. Similarly, the proximal end portions of the light receiving optical fiber 15 and the illumination optical fiber 16 are attached to the connection pins 23 and 24, respectively. The light projecting optical fiber 14 guides the excitation light incident on the proximal end thereof to the distal end. The light receiving optical fiber 15 guides the fluorescence incident on the tip thereof to the base end. The illumination optical fiber 16 guides illumination light (for example, visible light) incident on the proximal end thereof to the distal end.

The front end of the light projecting optical fiber 14 is opposed to the lens 17, and the front end of the light receiving optical fiber 15 is also opposed to the lens 17. The lens 17 is a collimating lens. That is, the lens 17 projects the excitation light emitted from the tip of the light projecting optical fiber 14 to the front of the tip of the probe 10 as substantially parallel light. The excitation light projected by the lens 17 passes through the light projection / receiving window 20. A measurement site of biological tissue arranged in front of the tip of the probe 10 is excited by excitation light and emits fluorescence. Fluorescence emitted from the measurement site of the living tissue passes through the light projecting and receiving window 20 and is collected by the lens 17 on the tip of the light receiving optical fiber 15.

The tip of the illumination optical fiber 16 is opposed to the illumination lens 18. Illumination light emitted from the tip of the illumination optical fiber 16 is projected forward of the tip of the probe 10 by the illumination lens 18.

The portion consisting of the connector housing 21, the connection pins 22 to 24, and the proximal end portions of the optical fibers 14 to 16 corresponds to the connector 11 of the probe 10. A portion including the lens 17, the illumination lens 18, the holder 19, and the light projecting / receiving window 20 corresponds to the light projecting / receiving unit 12 of the probe 10. The central portion of the tube 25 and the optical fibers 14 to 16 corresponds to the cable body 13 that connects the connector 11 and the light projecting / receiving unit 12.

Note that the light projecting and receiving window 20 may be provided on the side surface of the holder 19. In that case, a mirror is disposed inside the holder 19 and in front of the lens 17, and excitation light projected by the lens 17 is reflected by the mirror toward the light projecting / receiving window 20. The fluorescence emitted from the measurement site of the living tissue and transmitted through the light projecting and receiving window 20 is reflected toward the lens 17 by the mirror.

In addition, an imaging camera may be built in the holder 19. In that case, the periphery of the holder 19 is photographed by the imaging camera, and an image photographed by the imaging camera is transferred to the base unit 100. Since the probe 10 is disposable, it is preferable that the imaging camera is not incorporated as described above.

The number of optical fibers provided in the above probe 10 is 3, but the number of optical fibers may be 1 or 2, or may be 4 or more. When the number of optical fibers is 2, it is preferable that there is no illumination optical fiber 16 and the light projecting optical fiber 14 is used for both excitation light guiding and illumination light guiding. When the number of optical fibers is 1, it is preferable that the light projecting optical fiber 14 is also used for exciting light guiding, fluorescence guiding, and illumination light guiding.

[Adjustment jig]
The adjustment jig 30 will be specifically described.
FIG. 16 is an exploded perspective view of the adjustment jig 30. FIG. 17 is a cross-sectional view of the adjustment jig 30. As shown in FIGS. 16 and 17, the adjustment jig 30 includes a jig body 31, a first calibration target 52, a second calibration target 55, a push rod 53,

light shielding sheets

50 and 51, and a first light shielding cap 54. And a second light shielding cap 56 and the like.

The outer shape of the jig body 31 is a substantially rectangular parallelepiped shape. The jig body 31 has a light shielding property. If the material itself of the jig body 31 is not light-shielded, the surface of the jig body 31 is coated with a light-shielding coating.

挿入 In the end face 32 of the jig body 31, insertion holes 35 and 41 are opened. A first insertion hole 34 and a second insertion hole 40 that are internal spaces are formed in the jig body 31, and the first insertion hole 34 extends from the insertion port 35 to the inside of the jig body 31. The insertion hole 40 extends from the insertion port 41 into the jig body 31. The center lines of the insertion holes 34 and 40 extend linearly, and the insertion holes 34 and 40 penetrate from the one end surface 32 to the other end surface 33 of the jig body 31. Therefore, one end of each of the insertion holes 34 and 40 is opened at one end surface 32 as the

insertion ports

35 and 41, respectively, and the other end of the insertion holes 34 and 40 is respectively formed as the

insertion ports

36 and 42 at the other end surface 33. It is open. Note that the end surface 32 is the front surface of the jig body 31, and the end surface 33 is the rear surface of the jig body 31.

The first insertion hole 34 includes a first cavity portion 37 near the insertion port 35, a second cavity portion 38 near the intake port 36, and a third space between the first cavity portion 37 and the second cavity portion 38. It consists of a cavity 39. The first cavity part 37 and the third cavity part 39 are connected, and the second cavity part 38 and the third cavity part 39 are connected. The first cavity portion 37 is formed in a truncated cone shape, and the diameter of the first cavity portion 37 gradually decreases from the insertion port 35 toward the third cavity portion 39. The second cavity portion 38 and the third cavity portion 39 are formed in a columnar shape, and the diameters of the second cavity portion 38 and the third cavity portion 39 are equal to each other.

Similarly to the first insertion hole 34, the second insertion hole 40 also includes a first cavity portion 43, a second cavity portion 44, and a third cavity portion 45. However, the second cavity portion 38 of the first insertion hole 34 is formed in a columnar shape, whereas the second cavity portion 44 of the second insertion hole 40 is formed in a truncated cone shape, and the second cavity portion The diameter of 44 gradually decreases from the intake port 42 toward the third cavity 45. The third cavity 45 is formed in the shape of a truncated cone because the distance from the center line of the third cavity 45 to the inner wall of the third cavity 45 is made as large as possible and propagates in the third cavity 45. This is to make the light to be attenuated easily.

A ring-shaped stopper 46 is projected on the inner wall of the first insertion hole 34. The position where the stopper 46 is formed is a boundary portion between the second cavity portion 38 and the third cavity portion 39, and the second cavity portion 38 and the third cavity portion 39 communicate with each other through an opening 47 inside the stopper 46. Yes. A ring-shaped stopper 48 having an opening 49 is also provided on the inner wall of the second insertion hole 40 and at the boundary between the second cavity portion 44 and the third cavity portion 45. When the jig body 31 is formed by injection molding, the parting line is formed on the

stoppers

46 and 48 so as to surround the inner region corresponding to the

stoppers

46 and 48 by the joint of the mold. It is preferable.

Shielding

sheets

50 and 51 are attached to the inner walls of the insertion holes 34 and 40, respectively. Specifically, the

light shielding sheets

50 and 51 are attached to the inner walls of the

third cavities

39 and 45 in the insertion holes 34 and 40, respectively. The

light shielding sheets

50 and 51 are made of a polyurethane foam material (maltoprene) having elasticity. The

light shielding sheets

50 and 51 may be flocked. In addition, the inner wall of the

3rd cavity parts

39 and 45 may be embossed or embossed instead of sticking the

light shielding sheets

50 and 51. FIG.

It is preferable that the inner wall of the second insertion hole 40 is anti-reflection processed. For example, an AR (Anti-Reflection) film is formed on the inner wall of the second insertion hole 40, or an AR film is attached to the second insertion hole 40. The antireflection processing may be applied to the entire inner wall of the second insertion hole 40, or may be applied to the inner wall of the second cavity portion 44 in the second insertion hole 40.

The first calibration target 52 is accommodated in the first insertion hole 34. The installation position of the first calibration target 52 is opposite to the insertion port 35 with respect to the stopper 46, and more specifically, is closer to the stopper 46 in the second cavity portion 38. The first calibration target 52 is in contact with the stopper 46, and the opening 47 of the stopper 46 is closed by the first calibration target 52.

The push rod 53 is inserted into the first insertion hole 34 from the intake port 36 and is accommodated in the second cavity 38. The first calibration target 52 is inserted into the first insertion hole 34 from the intake port 36 by the push rod 53 and is abutted against the stopper 46 by the push rod 53.

A first light shielding cap 54 made of rubber or plastic is fitted into the inlet 36 so as to close the inlet 36 of the first insertion hole 34. The pushing rod 53 is held in a state of being sandwiched between the stopper 46 and the first calibration target 52 and the first light shielding cap 54.

The second calibration target 55 is accommodated in the second insertion hole 40. The installation position of the second calibration target 55 is on the opposite side of the insertion port 41 with respect to the stopper 48, and more specifically, closer to the intake port 42 in the second cavity 38. A second calibration target 55 is fitted into the intake port 42. The second calibration target 55 is integrally formed with a second light shielding cap 56 made of rubber or plastic, and the intake port 42 is covered with the second light shielding cap 56. The distance from the second calibration target 55 to the stopper 48 is longer than the distance from the first calibration target 52 to the stopper 46. The second calibration target 55 and the second light shielding cap 56 may be formed separately, and the second calibration target 55 may be attached to the second light shielding cap 56.

The light shielding caps 54 and 56 may be hardened adhesive. Further, the light shielding caps 54 and 56 may be bonded to the jig main body 31.

The color of the first calibration target 52 and the color of the second calibration target 55 are different. Specifically, the color of the second calibration target 55 is black, and the color of the first calibration target 52 is a color other than black (for example, white, red, green, blue, yellow, magenta, cyan, etc.). Yes, and particularly preferably, the color of the first calibration target 52 is white. The first calibration target 52 may be a uniform single color, or may be one in which various colors are arranged as in a so-called color chart.

The first calibration target 52 is, for example, a standard color chart such as Munsell color, a standard color plate (for example, a standard white plate), a standard fluorescent sample, or a Raman standard sample. The first calibration target 52 may include a base material and a standard color sheet (for example, Munsell color sheet) attached to the base material. The first calibration target 52 may be made of barium sulfate. Preferably, a barium sulfate molded into a tablet shape is used as the first calibration target 52.

The second calibration target 55 is a material that does not reflect light or a material with low light reflectivity. In order to prevent reflection of light at the second calibration target 55, the second calibration target 55 may be anti-reflection coated.

The jig body 31, the first calibration target 52, the second calibration target 55, the push rod 53, the first light shielding cap 54, and the second light shielding cap 56 preferably have chemical resistance. That is, the materials of the jig body 31, the first calibration target 52, the second calibration target 55, the push rod 53, the first light shielding cap 54, and the second light shielding cap 56 do not change in properties even in a sterilized gas environment. A material is preferable. This is because the adjustment jig 30 is mainly used as a medical device.
The material of the jig body 31, the first calibration target 52, the second calibration target 55, the push rod 53, the first light shielding cap 54, and the second light shielding cap 56 is preferably a heat resistant material. The material of the jig body 31, the first calibration target 52, the second calibration target 55, the push rod 53, the first light shielding cap 54, and the second light shielding cap 56 is preferably a material that does not deform even at high temperatures.

When using the adjustment jig 30, the light projecting / receiving part 12, which is the tip of the probe 10, is inserted into the first insertion hole 34 from the insertion port 35. Since the first cavity portion 37 is formed in a truncated cone shape and the insertion port 35 is greatly opened, the light projecting / receiving portion 12 of the probe 10 can be easily inserted into the first insertion hole 34.

Since the first cavity portion 37 is formed in a truncated cone shape, when the light projecting / receiving portion 12 of the probe 10 is pushed into the first insertion hole 34, the light projecting / receiving portion 12 is guided to the center. Therefore, the light projecting / receiving part 12 of the probe 10 can be easily inserted into the third cavity part 39.

When the light projecting / receiving part 12 of the probe 10 is pushed into the first insertion hole 34 and the tip of the light projecting / receiving part 12 (light projecting / receiving window 20) contacts the stopper 46, the light projecting / receiving part 12 is pushed further. Disappear. As a result, the position of the light projecting / receiving unit 12 is determined, and the front end of the light projecting / receiving unit 12 faces the first calibration target 52 in a light-tight state.

In the state where the tip of the light projecting / receiving unit 12 is in contact with the stopper 46, the opening 47 of the stopper 46 is blocked by the light projecting / receiving unit 12. Therefore, even if external light enters the insertion port 35, the external light does not reach the first calibration target 52.

In a state where the light projecting / receiving unit 12 is inserted into the third cavity 39, the light shielding sheet 50 is sandwiched between the inner wall of the third cavity 39 and the peripheral surface of the light projecting / receiving unit 12. Therefore, the first calibration target 52 can be shielded from light. When the inner walls of the

third cavities

39 and 45 are embossed or embossed instead of attaching the

light shielding sheets

50 and 51, the projections or embossed projections are projected and received by the light projecting / receiving unit 12. By contacting the peripheral surface, the first calibration target 52 can be shielded from light.

The light projecting / receiving unit 12 is inserted into the second insertion hole 40 from the insertion port 41 in the same manner as the light projecting / receiving unit 12 of the probe 10 is inserted into the first insertion hole 34 from the insertion port 35. Thereby, the front-end | tip of the light projection light-receiving part 12 can be directly opposed to the target 52 for 1st calibration in a light-tight state.

The order of insertion of the light projecting / receiving unit 12 is the first insertion hole 34 first and the second insertion hole 40 later. On the surface of the jig body 31 (particularly, the upper surface of the jig body 31) and at positions corresponding to the insertion holes 34 and 40,

reference numerals

57 and 58 representing the insertion order are assigned, respectively. With

such codes

57 and 58, the user can visually grasp the insertion order. Note that the insertion order may be reversed.

In the above description, the number of insertion holes formed in the jig body 31 is two. On the other hand, the number of the insertion holes may be 1, and only one of the insertion holes 34 and 40 may be formed in the jig body 31. Further, the number of insertion holes formed in the jig body 31 may be three or more. Even when the number of insertion holes is three or more, one or more insertion holes are formed in the jig body 31 in addition to the insertion holes 34 and 40, and these (or this) additional insertion holes The center line is parallel to the center line of the insertion holes 34, 40, and the opening (insertion opening) of these (or this) additional insertion holes opens at one end surface 32 of the jig body 31. Additional calibration targets of different colors are respectively accommodated in these (or this) additional insertion holes. If the number of insertion holes is 3 or more and the colors of the calibration targets 52 and 55 are white and black, respectively, the color of the additional calibration target is other than white and black, and the additional The color is different for each calibration target.

〔tray〕
The tray 70 will be specifically described.
As shown in FIG. 14, the tray 70 has a box-shaped tray body 71 having an open bottom surface. The tray body 71 is obtained by processing a thin plate material made of resin, paper, or metal into a box shape. The tray body 71 has chemical resistance and heat resistance, and the properties of the tray body 71 do not change even under a sterilization gas environment and a high temperature environment.

A probe storage recess 72 and an adjustment jig storage recess 76 are provided in the upper surface of the tray body 71. The probe 10 is stored in the probe storage recess 72. The adjustment jig 30 is housed in the adjustment jig housing recess 76.

The probe storage recess 72 includes a connector storage portion 73 in which the connector 11 is stored, a cable storage portion 74 in which the cable main body portion 13 is stored, and a tip end storage portion 75 in which the light projecting / receiving portion 12 is stored. . The cable storage portion 74 is a ring-shaped recess that is recessed in the upper surface of the tray body 71. The connector storage portion 73 is a concave portion provided in the upper surface of the tray main body 71. The connector housing 73 is connected to the cable housing 74 and extends in the tangential direction of the cable housing 74. The front end storage portion 75 is a recess provided in the tray body 71. The distal end storage portion 75 is connected to the cable storage portion 74 and extends in the tangential direction of the cable storage portion 74.

The adjustment jig storage recess 76 is formed in a rectangular shape when viewed from above. The position where the adjustment jig storage recess 76 is formed is in the vicinity of the tip end storage section 75.

FIG. 18 is a cross-sectional view of the adjustment jig storage recess 76 viewed from the side. The cross section in FIG. 18 is a plane parallel to the longitudinal direction of the adjustment jig housing recess 76 in plan view, and is a plane perpendicular to the upper surface of the tray body 71. As shown in FIG. 18, the cross-sectional shape of the adjustment jig storage recess 76 is wedge-shaped, and the bottom surface 77 of the adjustment jig storage recess 76 is inclined with respect to the upper surface of the tray body 71. Specifically, as shown in FIG. 14, the bottom surface 77 of the adjustment jig storage recess 76 is inclined downward in the direction toward the tip (butting) of the tip end storage section 75.

FIG. 19 is a perspective view showing a state in which the probe 10 and the adjustment jig 30 are stored on the tray 70. As shown in FIG. 19, the probe 10 is housed in the probe housing recess 72 so as to be fitted into the probe housing recess 72. Specifically, the light projecting / receiving portion 12 of the probe 10 is stored in the tip portion storage portion 75 so as to be fitted into the tip portion storage portion 75. The cable body 13 of the probe 10 is housed in the cable housing 74 so as to be fitted into the cable housing 74 in a spirally wound state. The cable main body 13 is spirally wound so that the connector 11 side overlaps the light projecting / receiving unit 12 side. The connector 11 of the probe 10 is housed in the connector housing portion 73 so as to be fitted into the connector housing portion 73. As described above, the probe 10 is housed in the probe housing recess 72, so that the connector 11 of the probe 10 can be easily taken out first as described later.

Conversely, the cable main body 13 may be spirally wound so that the light projecting / receiving portion 12 side overlaps the connector 11 side and stored in the cable storage portion 74. Depending on the elasticity of the cable main body 13, the cable main body 13 may protrude from the cable storage portion 74, so that the light projecting / receiving portion 12 side of the cable main body 13 overlaps the connector 11 side, so that the connector 11 It is possible to prevent the cable main body portion 13 from jumping out of the cable storage portion 74 at the time of taking out. In any case, considering the elasticity and length of the cable body 13 in a comprehensive manner, the light projecting / receiving part 12 side of the cable body 13 is overlaid on the connector 11 side, or the connector 11 side is projected. Select whether to superimpose on the light receiving unit 12 side.

The jig body 31 of the adjustment jig 30 is housed in the adjustment jig housing recess 76 so as to be fitted into the adjustment jig housing recess 76. Here, the surface of the jig body 31 on which the

reference numerals

57 and 58 are formed (the upper surface of the jig body 31) faces upward, and the opposite surface (the lower surface of the jig body 31) is the adjustment jig housing recess 76. The adjustment jig is housed in the adjustment jig housing recess 76 in a state facing the bottom surface 77.

Since the bottom surface 77 of the adjusting jig housing recess 76 is an inclined surface, the

insertion ports

35 and 41 are directed obliquely upward. The adjustment jig storage recess 76 is a substantially rectangular recess, and the jig of the adjustment jig 30 is placed with the rear surface 33 of the jig body 31 facing down and the front surface 32 of the jig body 31 facing up. The main body 31 may be housed in the adjustment jig housing recess 76, and the

insertion ports

35 and 41 may face upward. In this case,

reference numerals

57 and 58 are preferably attached to the front surface 32 of the jig body 31 in the vicinity of the

insertion ports

35 and 41, respectively.

Since the probe 10 is housed in the probe housing recess 72 as described above, the probe 10 is held by the tray body 71, and the probe 10 can be protected from impact or the like. Similarly, the adjustment jig 30 can be protected. Furthermore, the adjustment jig 30 and the probe 10 do not collide with each other during conveyance of the diagnostic package 1 or the like.

One or a plurality of elastic protrusions may be provided on the side surface of the probe storage recess 72, and when the probe 10 is stored in the probe storage recess 72, the elastic protrusion may be compressed by the probe 10. As a result, the probe 10 is supported by the elastic protrusion, and the probe 10 is unlikely to be detached from the probe storage recess 72. Similarly, one or a plurality of elastic protrusions may be provided on the side surface of the adjustment jig housing recess 76.

〔cover〕
The cover 80 will be specifically described. The cover 80 covers the upper surface of the tray body 71, and the probe storage recess 72 and the adjustment jig storage recess 76 are covered with the cover 80. The accommodated probe 10 and adjustment jig 30 are covered with a cover 80 to protect the probe 10 and adjustment jig 30. The cover 80 has chemical resistance and heat resistance, and the properties of the cover 80 do not change even under a sterilized gas environment and a high temperature environment.

A convex part 81 is formed on the lower surface of the cover 80 so as to overlap the probe accommodating concave part 72, and the convex part 81 enters the probe accommodating concave part 72 from above the probe 10. Thereby, the probe 10 is fixed firmly. Similarly, a convex portion 82 is formed on the lower surface of the cover 80, and the convex portion 82 enters the adjustment jig housing concave portion 76 from above the adjustment jig 30. Note that the cover 80 may be omitted.

[Packaging bag]
The packaging bag 90 will be specifically described.
As shown in FIGS. 13, 14, and 19, the packaging bag 90 wraps the probe 10, the adjustment jig 30, the tray 70 and the cover 80, and the probe 10, the adjustment jig 30, the tray 70 and the cover 80 are the packaging bag. 90. Of course, also in the packaging bag 90, the probe 10 is stored in the probe storage recess 72, and the adjustment jig 30 is stored in the adjustment jig storage recess 76.

FIG. 13 shows a state where the probe 10, the adjustment jig 30, the tray 70, and the cover 80 are packaged by the packaging bag 90. As shown in FIG. 13, the packaging bag 90 is sealed.

The packaging bag 90 preferably has light shielding properties. It is preferable that the packaging bag 90 has airtightness. The packaging bag 90 has chemical resistance, and the properties of the packaging bag 90 do not change even in a sterilized gas environment. Although the packaging bag 90 has gas permeability, micropores formed in the packaging body 90 are very small, and micrometer-order bacteria and dust do not penetrate the packaging body 90.

The packaging bag 90 is sterilized. Specifically, the probe 10, the adjustment jig 30, the tray 70 and the cover 80 are packaged by the packaging bag 90, and the packaging bag 90 is sealed, and the packaging bag 90 is heated at a high temperature in a high-temperature furnace. By being exposed to the atmosphere, the packaging bag 90 is sterilized.

[Base unit]
The base unit 100 will be described.
FIG. 20 is a perspective view of the base unit 100. FIG. 21 is a block diagram of the base unit 100. As shown in FIGS. 20 and 21, the base unit 100 includes a housing 101, a CPU 103, a RAM 104, a ROM 105, a signal processing unit 106, a photometry unit 107, light

emission control units

108 and 110, an illumination light source 109, a light source 111, and an interface 112. And a sensor 113.

The CPU 103, RAM 104, ROM 105, signal processing unit 106, photometry unit 107, light

emission control units

108 and 110, illumination light source 109, light source 111, interface 112, and sensor 113 are built in the housing 101.

A connecting portion 102 is provided on the front surface of the housing 101. The connector 11 of the probe 10 is connected to the connection unit 102. When the connector 11 of the probe 10 is connected to the connection portion 102, the base end of the light projecting optical fiber 14 is connected to the light source 111 via the optical waveguide, and the base end of the light receiving optical fiber 15 is connected to the photometry portion via the optical waveguide. 107, and the proximal end of the illumination optical fiber 16 is connected to the illumination light source 109 via an optical waveguide.

The sensor 113 is attached to the connection unit 102. The sensor 113 detects that the connector 11 is connected to the connection unit 102 and outputs a detection signal to the CPU 103. The sensor 113 is, for example, an infrared sensor, a micro switch, or a proximity sensor.

The ROM 105 stores a program that can be read by the CPU 103. The CPU 103 executes a program stored in the ROM 105, controls the signal processing unit 106, the photometry unit 107, the light

emission control units

108 and 110, and the interface 112 according to the program, and transfers signals and data between them. Do. The RAM 104 provides a work area for the CPU 103.

The CPU 103 performs a calculation related to the calibration according to the program, and records the calculation result (correction coefficient) in the RAM 104. The CPU 103 causes the photometry unit 107 to reflect the calculation result (correction coefficient).

The interface 112 is for transferring data between the CPU 109 and the computer 114 in accordance with a command from the CPU 109. An input device (for example, a keyboard and a mouse) 115 and a display monitor 116 are connected to the computer 114.

The light emission control unit 110 controls the light source 111 according to a command from the CPU 103. The light emission control unit 110 controls the light emission timing, the turn-off timing, the light emission intensity, and the like of the light source 111. Similarly, the light emission control unit 108 controls the illumination light source 109 in accordance with a command from the CPU 103.

The light source 111 generates excitation light (for example, X-rays, ultraviolet rays, visible rays, or electromagnetic waves).
The illumination light source 109 emits visible light as illumination light.

The photometry unit 107 separates the fluorescence input from the light receiving optical fiber 15 of the probe 10 and measures the intensity of the fluorescence for each wavelength. In addition, the photometry unit 107 measures the intensity of the fluorescence without splitting the fluorescence input from the light receiving optical fiber 15 of the probe 10. Hereinafter, the intensity for each wavelength measured by the photometric unit 107 is referred to as spectrum data, and the intensity measured without being spectrally separated by the photometric unit 107 is referred to as intensity data.
The photometry unit 107 measures spectral data and intensity data in a state where the calculation result (correction coefficient) input from the CPU 103 is reflected, and measures spectral data and intensity data in a state where the calculation result (correction coefficient) is not reflected. I also do.
Spectrum data and intensity data measured by the photometry unit 107 are transferred to the signal processing unit 106 by the CPU 103 or transferred to the computer 114 by the CPU 103 and the interface 112.
The signal processing unit 106 performs signal processing of spectrum data and intensity data.

[How to handle diagnostic packaging and operation of base unit]
The handling method of the diagnostic packaging 1 and the operation of the base unit 100 will be described.
FIG. 22 is a perspective view showing a usage state of the diagnostic packaging 1. FIG. 23 is a flowchart showing the flow of processing performed by the CPU 103 according to the program.

First, the CPU 103 waits until a detection signal is input from the sensor 113 (step S1: No).

At that time, the user opens the packaging bag 90 and removes the probe 10, the adjustment jig 30, and the cover 80 together with the tray 70 from the packaging bag 90. Next, the user removes the cover 80 from the tray 70. Next, the user takes out the connector 11 of the probe 10 from the connector storage portion 73 and connects the connector 11 to the connection portion 102 of the base unit 100. Since the cable body 13 is spirally wound so that the connector 11 side of the cable body 13 overlaps the light projecting / receiving part 12 side of the cable body 13, the user can easily take out the connector 11.

Also, the user reads the identifier 26 attached to the probe 10 and inputs the same value as the identifier 26 with the input device 115. The input identifier is transferred from the computer 114 to the CPU 103, and the CPU 103 records the input identifier in the RAM 104.

When the connector 11 is connected to the connection unit 102, the connector 11 is detected by the sensor 113, and a detection signal is output from the sensor 113 to the CPU 103. When the detection signal is input from the sensor 113 (step S1: Yes), the CPU 103 controls the light emission control unit 110 to cause the light source 111 to emit light (step S2). The excitation light emitted from the light source 111 is guided to the tip by the light projecting optical fiber 14 and projected by the lens 17. The connection of the connector 11 may not be detected by the sensor 113. In this case, the light source 111 is always in a light emitting state, and the CPU 103 recognizes the connection of the connector 11 from the change in the measurement result of the photometry unit 107. This is because when the connector 11 is connected to the connection unit 102, the measurement result of the photometry unit 107 changes.

Next, the CPU 103 outputs a display command to the computer 114 via the interface 112 (step S3). Receiving the display command, the computer 114 causes the display monitor 116 to display a screen for prompting the insertion and reception unit 12 of the probe 10 to be inserted into the insertion port 35 of the adjustment jig 30. At the same time, the computer 114 causes the display monitor 116 to display the same code as the code 57 attached to the surface of the jig body 31. Since the same symbol as the symbol 57 is displayed on the display monitor 116, the user can intuitively and visually understand the prompt for insertion of the probe 10 into the insertion port 35.

Next, the user inserts the light projecting / receiving part 12 of the probe 10 into the first insertion hole 34 from the insertion port 35, and brings the tip of the light projecting / receiving part 12 (light projecting / receiving window 20) into contact with the stopper 46. . Since the insertion port 35 is exposed obliquely upward, the light projecting / receiving portion 12 of the probe 10 can be inserted into the insertion port 35 without removing the adjustment jig 30 from the adjustment jig housing recess 76. Further, since the stopper 46 protrudes from the first insertion hole 34, even if the user cannot look into the first insertion hole 34, the tip of the light projecting / receiving unit 12 is positioned at an appropriate position. The first calibration target 52 can be directly opposed. In addition, when the user brings the tip of the light projecting / receiving unit 12 (light projecting / receiving window 20) into contact with the stopper 46, the distance from the tip of the light projecting / receiving unit 12 to the first calibration target 52 is appropriately set. The Further, since the first calibration target 52 is disposed near the stopper 46, the tip of the light projecting / receiving unit 12 can be positioned in the immediate vicinity of the first calibration target 52.

When the leading end of the light projecting / receiving unit 12 is inserted up to the stopper 46, the excitation light emitted from the leading end of the projecting optical fiber 14 is projected onto the first calibration target 52 by the lens 17. The excitation light is reflected by the first calibration target 52, and the reflected light is condensed by the lens 17 on the tip of the light receiving optical fiber 15. The reflected light received at the tip of the light receiving optical fiber 15 is guided to the photometry unit 107 by the light receiving optical fiber 15. Since the tip of the light projecting / receiving unit 12 is located in the immediate vicinity of the first calibration target 52, excitation light and reflected light are hardly attenuated, and reflected light with high intensity is incident on the tip of the light receiving optical fiber 15. .

When the tip of the light projecting / receiving unit 12 is inserted to the stopper 46, the user operates the input device 115. When a signal based on the operation is output from the computer 114 to the CPU 103, the CPU 103 causes the photometry unit 107 to perform photometry processing (step S4). Thereby, spectrum data and intensity data are measured by the photometry unit 107.

Next, the CPU 0103 performs a calibration process (step S5). Specifically, the CPU 103 determines whether or not the spectrum data and intensity data measured by the photometry unit 107 are included in an appropriate range. Further, the CPU 013 calculates a correction coefficient from both or one of spectrum data and intensity data measured by the photometry unit 107. If the color of the first calibration target 52 is white, such calibration processing is intended to adjust the white balance, and also adjusts variations based on individual differences and combinations of the probe 10, the light source 111, and the photometry unit 107. With the goal.

Next, the CPU 103 records the determination result and the correction coefficient in step S5 in the RAM 104 (step S6). At this time, the CPU 103 associates the determination result and the correction coefficient with the previously recorded input identifier.

Next, the CPU 103 outputs a display command to the computer 114 via the interface 112 (step S7). Receiving the display command, the computer 114 causes the display monitor 116 to display a screen that prompts the user to insert the light projecting / receiving unit 12 of the probe 10 into the insertion port 41 of the adjustment jig 30. In addition, the computer 114 causes the display monitor 116 to display the same reference numeral as the reference numeral 58 attached to the surface of the jig main body 31. Thereby, the user can easily understand the insertion prompt to the insertion port 41.

Next, the user pulls out the light projecting / receiving portion 12 of the probe 10 from the first insertion hole 34. Then, the user inserts the light projecting / receiving unit 12 of the probe 10 into the second insertion hole 40 from the insertion port 41, and brings the tip of the light projecting / receiving unit 12 into contact with the stopper 48. Further, since the second calibration target 55 is disposed away from the stopper 48, the tip of the light projecting / receiving unit 12 can be disposed away from the second calibration target 55.

Next, when the user operates the input device 115, the CPU 103 controls the photometry unit 107, and the photometry unit 107 measures spectrum data and intensity data (step S8). In this photometry, the CPU 103 may turn on the light source 111 or may turn it off.

Next, the CPU 0103 determines whether or not the spectrum data and intensity data measured by the photometry unit 107 are included in an appropriate range, and corrects from both or one of the spectrum data and intensity data measured by the photometry unit 107. A coefficient is calculated (step S9). If the color of the second calibration target 55 is black, the excitation light is hardly reflected by the second calibration target 55. Even if the excitation light is reflected by the second calibration target 55, the reflected light is easily attenuated because the distance from the tip of the light projecting / receiving unit 12 to the second calibration target 55 is large. In addition, since the third cavity 45 is formed in a truncated cone shape, the light propagating in the third cavity 45 is likely to be attenuated. Therefore, the intensity of the excitation light incident on the tip of the light receiving optical fiber 15 is also very low. Therefore, the calibration process of step S9 aims at grasping the intensity of stray light and the intensity of reflection noise derived from the lens 17 of the probe 10, the

optical fibers

14, 15 and the like.

Next, the CPU 103 records the determination result in step S9 and the correction coefficient in the RAM 104 in association with the input identifier (step S10). Then, the CPU 103 ends the process with the determination result, the correction coefficient, and the input identifier stored in the RAM 104.

As described above, the user handles the diagnostic package 1 and the processing of the CPU 103 is performed, whereby calibration is performed. When the base unit 100 has a recording medium (for example, a non-volatile memory, a magnetic disk drive, etc.) and the processing shown in FIG. 23 is completed, the CPU 103 records the input identifier, the determination result, and the correction coefficient recorded in the RAM 104. You may record on a medium. By doing so, the input identifier, determination result, and correction coefficient for each probe 10 are accumulated in the recording medium, and it becomes easy to perform feedback such as lot management.

23. When the user removes the connector 11 from the connection unit 102 during or after the process shown in FIG. 23, the sensor 113 detects that fact. Then, the CPU 103 deletes the input identifier, the determination result, and the correction coefficient stored in the RAM 104.

After the calibration as described above is performed, the user pulls out the light projecting / receiving unit 12 of the probe 10 from the second insertion hole 40 without removing the connector 11 from the connection unit 102. Then, if necessary, the light projecting / receiving portion 12 of the probe 10 is inserted into the lumen using the forceps channel of the endoscope. At that time, the illumination light source 109 may be turned on to illuminate the periphery of the light projecting / receiving unit 12.

Thereafter, the light source 111 is turned on by the CPU 103. Then, the excitation light is projected from the tip of the light projecting / receiving unit 12 of the probe 10 onto the measurement site of the living tissue by the projecting optical fiber 14 and the lens 17. The measurement site of the living tissue emits fluorescence due to the excitation light, and the fluorescence is received at the tip of the light projecting / receiving unit 12 of the probe 10. The received fluorescence is transmitted to the photometry unit 107 by the light receiving optical fiber 15. The CPU 103 causes the photometric unit 107 to reflect the correction coefficient recorded in the RAM 104. Then, the intensity data and spectrum data of the fluorescence received by the photometry unit 107 are measured, and the intensity data and spectrum data are corrected with a correction coefficient. The intensity data and spectrum data corrected by the correction coefficient are signal processed by the signal processing unit 106 or transferred to the computer 114 by the CPU 103 and the interface 112. The computer 114 causes the display monitor 116 to display the corrected intensity data and spectrum data. Thereby, the measurement site | part of a biological tissue can be diagnosed.

Since the probe 10 is disposable, after diagnosis, the connector 11 is removed from the connection portion 102 and the probe 10 is discarded. The adjusting jig 30, the tray 70, the cover 80, and the packaging bag 90 are also discarded. Note that the adjustment jig 30 may be reused for calibration of another probe 10.

〔effect〕
According to the above embodiment, the following effects can be obtained.

(1) Since the probe 10 and the adjustment jig 30 are a set, it is not necessary to prepare a large-scale adjustment jig different from the adjustment jig 30.
(2) Since the probe 10 and the adjustment jig 30 are a set, the user notices the presence of the adjustment jig 30 when the packaging bag 90 is opened. Therefore, the user remembers to calibrate the probe 10 using the adjustment jig 30 before performing the fluorescence diagnosis using the probe 10.
(3) Since the probe 10 and the adjustment jig 30 are a set, the new adjustment jig 30 can be used for calibration of the probe 10. There is no deterioration, discoloration, or the like of the calibration targets 52 and 55 of the adjustment jig 30, and accurate calibration can be performed.
(4) Since the diagnostic packaging 1 is simply configured, the cost of the diagnostic packaging 1 is low.
(5) Since the storage of the probe 10 and the adjustment jig 30 is devised, it is easy to use. Calibration can be performed without taking out the adjustment jig 30.
(6) Since the probe 10 and the adjustment jig 30 are disposable, they are convenient and hygienic.
(7) Since the adjustment jig 30 is provided with a plurality of insertion holes and a plurality of calibration targets, the calibration can be performed a plurality of times.
(8) Since the

reference numerals

57 and 58 are attached to the upper surface of the main body 31 of the adjustment jig 30, the order of calibration is not mistaken.
(9) Since the prompt for insertion and the insertion order into the insertion holes 34 and 40 of the light projecting / receiving unit 12 of the probe 10 are displayed on the display monitor 116, the calibration can be performed without mistakes. Furthermore, the calibration is completed without allowing the user to recognize the calibration action.
(10) When the connector 11 of the probe 10 is connected to the connection portion 102 of the base unit 100, insertion prompts to the insertion holes 34 and 40 of the light projecting / receiving portion 12 of the probe 10 are displayed on the display monitor 116. The user never forgets to calibrate.
(11) Calibration can be performed by a simple operation of simply inserting the light projecting / receiving portion 12 of the probe 10 into the insertion holes 34 and 40. For this reason, it is not necessary to require the user to perform special work / load.
(12) By the

stoppers

46 and 48, the distance from the tip of the light projecting / receiving unit 12 of the probe 10 to the calibration targets 52 and 55 can be made appropriate.
(13) Since the calibration targets 52 and 55 are shielded by the

light shielding sheets

50 and 51, the calibration accuracy is high.
(14) When the tip of the light projecting / receiving unit 12 of the probe 10 is brought into contact with the

stoppers

46 and 48, the calibration targets 52 and 55 are shielded from light so that the calibration accuracy is high. Since the

stoppers

46 and 48 are provided in a ring shape, the

stoppers

46 and 48 do not hinder light projection and light reception.

[Modification of adjustment jig]
FIG. 24 is an exploded perspective view of the adjustment jig 30A. FIG. 25 is a cross-sectional view of the adjustment jig 30A. Parts corresponding to each other between the adjustment jig 30 shown in FIGS. 16 and 17 and the adjustment jig 30A shown in FIGS. 24 and 25 are denoted by the same reference numerals. Hereinafter, the difference between the adjustment jig 30 shown in FIGS. 16 and 17 and the adjustment jig 30A shown in FIGS. 24 and 25 will be mainly described.

In the adjustment jig 30, the first insertion hole 34 includes the hollow portions 37 to 38, whereas in the adjustment jig 30 A, the first insertion hole 34 includes the

hollow portions

38 and 39. Similarly, in the adjustment jig 30, the second insertion hole 40 includes the hollow portions 43 to 45, whereas in the adjustment jig 30 A, the second insertion hole 40 includes the

hollow portions

44 and 45. That is, there are no

frustoconical cavities

37 and 43. Therefore, the length of the adjustment jig 30 </ b> A from the end surface 32 to the end surface 33 of the jig main body 31 is shorter than that of the adjustment jig 30. Further, in the adjustment jig 30, the ends of the

hollow portions

37 and 43 are opened as the

insertion ports

35 and 41 on the end surface 32 of the jig main body 31, whereas in the adjustment jig 30 A, the

hollow portions

39 and 43 are formed. 45 ends open on the end face 32 of the jig body 31 as

insertion openings

35 and 41, respectively. That is, in this adjustment jig 30A, the

insertion ports

35 and 41 are the ends of the insertion holes 34 and 40, respectively.

The adjustment jig 30A includes a jig body 31, a first calibration target 52, a second calibration target 55, a push rod 53,

light shielding sheets

50 and 51, a first light shielding cap 54, a second light shielding cap 56, and the like. In addition,

flexible tubes

60 and 61 are provided.

One end of the

flexible tubes

60 and 61 is attached to the end surface 32 of the jig main body 31, and the

flexible tubes

60 and 61 extend in the center line direction of the insertion holes 34 and 40, respectively. Both ends of the

flexible tubes

60 and 61 are open. The internal spaces of the

flexible tubes

60 and 61 communicate with the insertion holes 34 and 40 through the

insertion ports

35 and 41, respectively.

Reference numerals

57 and 58 are attached to the peripheral surfaces of the

flexible tubes

60 and 61, respectively.

Reference numerals

57 and 58 may be attached to the surface of the jig body 31 (particularly, the upper surface of the jig body 31).

The adjustment jig 30 </ b> A is stored in the adjustment jig storage recess 76 of the tray 70 instead of the adjustment jig 30. Since the bottom surface 77 of the adjusting jig housing recess 76 is an inclined surface, the openings at the ends of the

flexible tubes

60 and 61 are directed obliquely upward.

Except as described above, the portions corresponding to each other between the adjustment jig 30 shown in FIGS. 16 and 17 and the adjustment jig 30A shown in FIGS. 24 and 25 are similarly provided. It has been.

When the prompting screen is displayed on the display monitor 116 as in step S3 shown in FIG. 23, the user inserts the light projecting / receiving unit 12 of the probe 10 into the flexible tube 60 and the light projecting / receiving unit 12 The tip is brought into contact with the stopper 46. When the prompting screen is displayed on the display monitor 116 as in step S7 shown in FIG. 23, the user inserts the light projecting / receiving unit 12 of the probe 10 into the flexible tube 61 and the light projecting / receiving unit 12 The tip is brought into contact with the stopper 48.

Since the

flexible tubes

60 and 61 are flexible, the

flexible tubes

60 and 61 can be bent and the end openings of the

flexible tubes

60 and 61 can be directed upward. Therefore, it is easy to insert the light projecting / receiving portion 12 of the probe 10 into the end openings of the

flexible tubes

60 and 61.

The present invention can be used for optical measurement of living tissue.

<References in FIGS. 1 to 12B only>
DESCRIPTION OF SYMBOLS 1 Optical measuring system 10 Probe 11 Tip part 12 Connector part 12a surface (upper surface at the time of a connection)
12b Hole portion 13 Cable portion 14 (a to g) Light guiding optical fiber 15 Lens 16 Optical component 17 Exterior tube 20 Base unit 21 Connection portion 30 Packaging tray 40 (AE) Correction measurement environment component 41 Opening portion 42 Optical

environment holding chambers

43 and 44 Measurement target substances 45 to 47 Wall portion 48 Light shielding member 49 Protruding portion 50 Biological tissue 51 Protruding portion 52 Outer peripheral groove 53 Marking C Connector insertion direction <reference numerals in FIGS.
DESCRIPTION OF SYMBOLS 1 Diagnosis package 10 Probe 11 Connector 12 Light projection light-receiving part 13 Cable main-

body part

30 and 30A Adjustment jig 31 Jig

main body

34 and 40

Insertion hole

35 and 41

Insertion target

52 and 55

Calibration target

46 and 48

Stopper

50 , 51

Shielding sheet

54, 56

Shielding cap

60, 61 Flexible tube 70 Tray 71 Tray body 72 Probe housing recess 73 Connector housing portion 74 Cable housing portion 75 Tip portion housing portion 76 Adjusting jig housing recess 90 Packaging bag

Claims

A probe for measuring the radiated light with an optical system for receiving the radiated light emitted from the measurement target site by irradiating the measurement target site of the biological tissue with irradiation light,
At one end, it has a connector part connected to a base unit having a detector, at the other end, a tip part in which a light receiving optical system including at least an optical fiber or an image sensor is configured,
An optical environment holding chamber having an opening portion into which the tip portion is inserted is configured, and the tip portion is inserted into the optical environment holding chamber from the opening portion, so that the tip portion has a known optical environment. A probe in which a measurement environment component for correction that provides an environment is provided in the connector portion.
2. The probe according to claim 1, wherein the measurement environment component for correction includes a light shielding member that blocks external light from entering the optical environment in a state where at least the tip portion is inserted.
The probe according to claim 1 or 2, wherein the correction measurement environment component includes a predetermined measurement target substance in the optical environment holding chamber.
The locking structure for restricting further insertion of the tip portion inserted into the measurement environment component for correction with a predetermined insertion length is configured. The probe according to 1.
The locking structure is configured to restrict further insertion of the distal end portion inserted into the measurement environment component for correction with a predetermined insertion length with a predetermined locking force and to prevent extraction. The probe according to any one of claims 1 to 3.
The mark which displays the length from the front-end | tip corresponded to the insertion length which should be applied at the time of the measurement for correction | amendment was provided in the outer periphery of the said front-end | tip part, Any one of Claim 1-5 characterized by the above-mentioned. The probe as described.
A probe according to any one of claims 1 to 6;
An optical measurement system comprising a base unit to which the connector portion of the probe is connected,
The base unit is
A light source device for the irradiation light;
A detector for detecting the light intensity of the emitted light;
The measurement result for correction measured in the optical environment by the measurement environment component for correction is stored and stored, and the measurement result of the living tissue for the living tissue is determined based on the measurement result for correction in accordance with a predetermined algorithm. An optical measurement system having an arithmetic processing unit that corrects the signal.
A probe according to any one of claims 1 to 6;
An optical measurement system comprising a base unit to which the connector portion of the probe is connected,
The base unit is
A light source device for the irradiation light;
A detector for detecting the light intensity of the emitted light;
The measurement result for correction measured in the optical environment by the measurement environment component for correction is stored and stored, and based on the measurement result for correction, the gain of the detector or the attenuation filter is determined according to a predetermined algorithm. An optical measurement system having an arithmetic processing unit for setting transmittance.
A probe according to any one of claims 1 to 6;
An optical measurement system comprising a base unit to which the connector portion of the probe is connected,
The base unit is
A light source device for the irradiation light;
A detector for detecting the light intensity of the emitted light;
The measurement result for correction measured in the optical environment by the measurement environment component for correction is stored and stored, and based on the measurement result for correction, the light source device, the detector, or them according to a predetermined algorithm And an arithmetic processing unit that movably adjusts at least one movable part of the mechanism for optically connecting the probe.
The correction measurement environment configuration of the tip portion has a mechanical structure in which connection to the base unit is allowed only in a certain orientation, and the connector portion is connected to the base unit. 10. The optical measurement system according to claim 7, wherein the correction measurement environment component is configured so as to regulate a direction of insertion into an object vertically downward or obliquely downward.
A method for providing a user of the probe according to any one of claims 1 to 6, comprising:
A sterilization step of sterilizing the probe including the correction measurement environment component;
A probe providing method to a user, comprising: a packaging step of packaging the probe in the same package including the correction measurement environment component.
A tray,
A probe housed in the tray for transmitting, projecting and receiving light;
A calibration target that is irradiated with light emitted from the probe during calibration of the probe, holding the probe during calibration of the probe, and an adjustment jig housed in the tray;
A diagnostic package comprising the probe, the adjustment jig, and a packaging bag enclosing the tray.
The tray has a tray body, a probe storage recess recessed in the upper surface of the tray body, and an adjustment jig storage recess recessed in the upper surface of the tray body,
The diagnostic packaging according to claim 12, wherein the probe is stored in the probe storage recess, and the adjustment jig is stored in the adjustment jig storage recess.
The probe storage recess is a ring-shaped cable storage portion recessed in the upper surface of the tray main body, and is recessed in the upper surface of the tray main body, connected to the cable storage portion, and from the cable storage portion to the cable storage portion. A connector storage portion extending in a tangential direction of the tray, and a tip storage portion recessed in the upper surface of the tray body, connected to the cable storage portion, and extending from the cable storage portion in the tangential direction of the cable storage portion. Have
The probe is connected to a cable main body for transmitting light, a connector for inputting / outputting light, and connected to a distal end of the cable main body for light projection and light reception. A light receiving and receiving unit,
The diagnostic packaging according to claim 13, wherein the light projecting / receiving unit is stored in the tip storage unit, the cable body unit is stored in the cable storage unit, and the connector is stored in a connector storage unit. .
The diagnostic packaging according to claim 14, wherein the cable main body is wound and stored in the cable storage.
The diagnostic package according to claim 15, wherein the cable main body is spirally wound so that the connector side overlaps the light projecting / receiving portion side.
The diagnostic package according to claim 15, wherein the cable body is spirally wound so that the light projecting / receiving portion side overlaps the connector side.
The adjustment jig includes a jig main body stored in the adjustment jig storage recess, an insertion opening opened on the surface of the jig main body, and an insertion hole extending from the insertion opening to the inside of the jig main body. And having
The diagnostic packaging according to any one of claims 13 to 17, wherein the calibration target is disposed in the insertion hole.
The diagnostic packaging according to claim 18, wherein the insertion hole is closed on the opposite side of the insertion port.
The adjustment jig further has a stopper protruding from the inner wall of the insertion hole,
20. The diagnostic package according to claim 18 or 19, wherein the calibration target is disposed in the insertion hole on the opposite side of the insertion port with respect to the stopper.
The diagnosis according to any one of claims 18 to 20, wherein the jig body of the adjustment jig is housed in the jig housing recess with the insertion port facing obliquely upward. Packaging.
The diagnostic package according to any one of claims 18 to 21, wherein the adjustment jig further includes a light shielding sheet attached to an inner wall of the insertion hole.
The diagnosis according to any one of claims 18 to 22, wherein the adjustment jig further includes a flexible tube attached to the jig body so as to communicate with the insertion hole through the insertion port. Packaging.
The number of the insertion port, the insertion hole, and the calibration target is plural, and the calibration target is disposed in the insertion hole, respectively. The diagnostic packaging as described.
25. The diagnostic packaging according to claim 24, wherein the color is different for each calibration target.
26. The diagnostic packaging according to claim 24 or 25, wherein any one of the calibration targets has a white color and any other calibration target has a black color.