JP2012034824A - Interface member and interface member peeling mechanism - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an interface member for performing organism light irradiation and detection, which fixes an optical probe and also creates an optically excellent state by adjusting the optical characteristic values of an organism tissue and an optical member even concerning long-term light measurement and light irradiation.SOLUTION: The interface member is used for fixing the optical probe, which irradiates a living body with light or detects light, onto the surface of the living body. The interface member includes: a base member 31, which has an adherence property on both surfaces of a probe adhering surface 31a for fixing and holding the optical probe and an organism adhering surface 31b to be fixed on the surface of the living body; and an optical characteristic matching part 32, of which the thickness is ≥5 μm and ≤50 μm and the refractive index is ≥1.3 and ≤1.6 and which is provided at a position 35 corresponding to the light irradiation part or detection part of the base member 31, to match the refractive index of light between the optical probe and the living body. The base member 31 is integrally constituted with the optical characteristic matching part 32.

Description

  The present invention relates to an interface member for fixing an optical probe used for irradiating or detecting ultraviolet light, visible light, near infrared light, or infrared light to a living body. A living body that is fixed and is interposed between an optical member such as an optical fiber, a glass cover, and a plastic cover that constitute a light irradiation or detection portion of the optical probe and the surface of the living body, and stabilizes the light irradiation or detection state. The present invention relates to an interface member for detecting light irradiation and an interface member peeling mechanism.

  In particular, it optically stabilizes the state of the optical member and the surface of the living body when the optical probe is mounted on the surface of the living body over a long period of time ranging from several hours to several days. The present invention relates to an interface member for detecting detection of living body light and an interface member peeling mechanism for fixing an irradiation probe of a device for performing care and treatment of a living body by light irradiation to a living body surface.

  In recent years, in order to manage the blood glucose level of diabetic patients, there is an increasing need for blood glucose level measurement and blood glucose level monitoring. Furthermore, by managing the blood glucose level in an appropriate range in the intensive care unit (ICU), effects such as a decrease in mortality and a decrease in the incidence of complications have been medically demonstrated.

  There are two main methods for measuring blood glucose levels. One is an invasive technique in which blood is collected and quantified using an enzyme reaction such as glucose oxidase. Invasive methods include enzyme electrode methods such as glucose oxidase (GOD) method and glucose dehydrogenase (GDH) method, and enzyme colorimetric methods such as hexokinase (HX) method. The other is a non-invasive technique for estimating blood glucose levels based on some information obtained from a living body without performing an operation such as blood collection to damage the body.

  Various methods for non-invasively estimating blood glucose levels have been proposed, and among them, a method using near infrared light is known (for example, see Patent Document 1). The method of non-invasively measuring blood glucose levels using near-infrared light irradiates living tissue with near-infrared light, measures the light diffusely reflected inside the living tissue, and qualitatively determines the blood glucose level from the signals and spectrum obtained.・ This is a method for quantitative analysis.

  The technique for estimating blood glucose level non-invasively can measure blood glucose level without imposing a burden on the patient. Therefore, the needs are high, and various measurement techniques have been proposed. However, there are still problems with estimation accuracy and reliability, and there are no products that have obtained Japanese regulatory approval or US FDA approval at this time. In other words, the method for non-invasively estimating the blood glucose level is not limited to the near-infrared spectroscopy, but a signal serving as a substitute characteristic of the blood glucose level included in the signal measured by any method is compared with the disturbance signal. Because it is very small, it is strongly affected by disturbances. For this reason, the measurement method inherently causes a large error. Therefore, the non-invasive technique is inferior to some extent inferior in estimation accuracy and reliability as compared to the invasive technique. However, since the noninvasive method can measure without damaging the living body, frequent measurement and continuous measurement are possible. This frequent measurement and continuous measurement are very important features in blood glucose level management, and there is a possibility that it may compensate for the disadvantage of poor estimation accuracy and reliability in a specific application.

  When performing frequent measurement or continuous measurement by a non-invasive technique, it is necessary to attach an optical probe to the surface of the living body. Typical methods for fixing an optical probe to the surface of a living body include a method of binding to a living body with a binding band, a single-sided tape, a clip, a helmet-shaped holder, etc., and a method of attaching a double-sided tape to the surface of a living body. It is a technique.

  A typical example of a technique for binding an optical probe to a living body is a sensor portion of a medical pulse oximeter. An example of the disposable sensor shown in FIG. 7 is one in which a light receiving / emitting element as an optical member is attached to an adult finger. The light receiving element 1 and the light emitting element 2 encapsulated in resin are attached to a single-sided surgical tape 3. In use, the release paper 4 is peeled off, and the surgical tape 3 is wound around the finger as shown in FIG. 8, so that the light receiving element and the light emitting element can be easily fixed to face each other via the finger 6. In addition, since this disposable sensor is discarded every time it is used, it is easy to prepare for wearing, and there is no need for maintenance related to element deterioration or cleaning of the optical probe. Other patients use the sensor once used. And has the advantage of being hygienic.

  As an example of a method for attaching an optical probe to the surface of a living body through a double-sided tape, there is a method for fixing a measurement probe of a laser Doppler velocimeter using a double-sided tape. The measurement probe shown in FIG. 9 is one in which an optical fiber end portion 9 for receiving and emitting light, which is an optical member, is fixed to an adult finger by using a double-sided tape 7. It has a donut shape that cuts through the center so that it does not hang over the tape.

  However, the optical probe fixing method described above is mainly intended to fix the optical probe to the surface of the living body, and reduces the adverse effects due to the optical characteristics of the optical member and the skin surface, that is, the refractive index and scattering. There is no device that stabilizes the input and output of light.

  As a technique for adjusting the optical characteristics of the optical member and the surface of the skin and improving the input / output of light, a technique is known in which a refractive index matching material (matching material) such as mineral oil is interposed between the living tissue and the optical member. ing. In this method, mineral oil (refractive index 1.48) or the like is interposed so that an air layer (refractive index 1) cannot be formed between a glass material having a refractive index of approximately 1.45 and a living tissue having a refractive index of approximately 1.37. Thus, it is a method of obtaining good light input / output by reducing reflected light caused by a large difference in refractive index from the air layer. Mineral oil, which is a liquid, quickly flows between the living tissue and the glass material due to surface tension, etc., and fills the gap between both, so a liquid having a refractive index close to that of the living tissue and the glass material is interposed between the two. The state of light irradiation to the living body or light detection from the living body can be improved. However, this method is effective for one-shot measurement or light irradiation in a short time, but for long-time measurement or light irradiation, the skin tissue is denatured by mineral oil, the mineral oil is taken into the living tissue, The measurement state changes due to various factors such as vaporization into the air, and a stable light input / output state cannot be maintained.

JP 2006-087913 A

  The conventional method of fixing an optical probe is mainly to fix the optical probe to the surface of a living body, and input / output of ultraviolet, visible, near infrared, and infrared light irradiated or detected by the optical probe. There has been little ingenuity to stabilize the state. Also, the method of interposing a mineral refractive index matching material (matching material) used as a technique to adjust the refractive index of living tissue and optical members to create an optically good state is about light measurement and light irradiation for a long time Cannot obtain stable input / output.

  The present invention has been made in view of such problems of the prior art, and fixes an optical probe and adjusts the optical characteristic values of a living tissue and an optical member for long-time optical measurement and light irradiation. It is an object of the present invention to provide an interface member for detecting detection of living body light and an interface member peeling mechanism capable of producing an optically good state.

  An interface member according to an embodiment of the present invention is an interface member that is used to fix an optical probe that irradiates or detects light to a living body on the surface of the living body, and a probe sticking surface that fixes and holds the optical probe and the living body surface The base member having adhesiveness on both surfaces of the bioadhesive surface to be fixed to the surface, and a position corresponding to the light irradiation part or the detection part of the base member, the thickness is 5 μm or more and 50 μm or less, and the refractive index is 1. It is 3 to 1.6, and includes an optical probe and an optical characteristic matching unit that matches the refractive index of light between living bodies, and the base member and the optical characteristic matching unit are configured integrally. To do.

  An interface member peeling mechanism according to an aspect of the present invention includes an interface member and a reinforcing adhesive member that is attached to an optical property matching portion of the interface member and mechanically reinforces the optical property matching portion. The gist is to use it when peeling the probe.

  According to the present invention, biological light that can fix an optical probe and adjust an optical characteristic value of a biological tissue and an optical member for long-time optical measurement and light irradiation to create an optically good state. An interface member for detecting irradiation and an interface member peeling mechanism can be provided.

It is a plane schematic diagram of the interface member concerning an embodiment of the invention. It is a section schematic at the time of using the interface member concerning an embodiment of the invention. It is the schematic of an optical blood glucose level measurement system. It is a graph which shows the result of having performed blood glucose level measurement using the interface member concerning an embodiment of the invention. It is a graph which shows the result of having conducted the blood glucose level measurement experiment as a comparative example. It is the schematic of the interface member which concerns on embodiment of this invention. It is the schematic (the 1) which shows the sensor used with the conventional measurement system. It is the schematic (the 2) which shows the sensor used with the conventional measurement system. It is the schematic (the 3) which shows the sensor used with the conventional measurement system.

  Embodiments of the present invention will be described below with reference to the drawings. In the following description of the drawings, the same or similar parts are denoted by the same or similar reference numerals. However, the drawings are schematic, and the relationship between the thickness and the planar dimensions, the ratio of the thickness of each layer, and the like are different from the actual ones. Therefore, specific thicknesses and dimensions should be determined in light of the following description. Moreover, it is a matter of course that portions having different dimensional relationships and ratios are included between the drawings.

(Embodiment)
As shown in FIGS. 1 and 2, the interface member according to the embodiment of the present invention is an interface member used for fixing an optical probe 18 that irradiates or detects light to a living body on the surface of the living body, A base member 31 having adhesiveness on both of a probe sticking surface 31a for fixing and holding the optical probe 18 and a biological sticking surface 31b fixed on the surface of the living body, and a position 35 corresponding to the light irradiation part or detection part of the base member 31 An optical characteristic matching unit 32 that has a thickness of 5 μm or more and 50 μm or less, a refractive index of 1.3 or more and 1.6 or less, and that matches the refractive index of light between the optical probe 18 and the living body. The base member 31 and the optical characteristic matching unit 32 are integrally formed.

  The interface member according to the embodiment of the present invention can be used in an optical blood sugar level measuring system as shown in FIG. An optical blood glucose level measurement system can be used. In this optical blood glucose level measurement system, as shown in FIG. 3A, first, near infrared light emitted from a halogen lamp (light source) 10 is converted into a heat shielding plate 11, a pinhole 12, a lens 13, and an optical fiber bundle. 14 is incident on the living tissue 15 via the.

  One end of the measurement optical fiber 16 and one end of the reference optical fiber 17A are connected to the optical fiber bundle 14. One end of the measurement optical fiber 16 is connected to the skin tissue measurement probe 18, and the other end of the reference optical fiber 17 A is connected to the reference probe 19. Furthermore, the skin tissue measurement probe 18 and the reference probe 19 are connected to the measurement-side emitter 20 and the reference-side emitter 21 via the measurement optical fiber 16 and the reference optical fiber 17B, respectively.

  When near-infrared spectrum measurement is performed by bringing the tip of the measurement probe 18 into contact with the surface of a living tissue 15 such as a forearm of a human body, near-infrared light incident on the optical fiber bundle 14 from the halogen lamp 10 is an optical fiber. The light is transmitted through the bundle 14 and irradiated onto the surface of the living tissue 15 from 12 light emitting fibers 30 arranged concentrically at the tip of the measurement probe 18 as shown in FIG.

  After the near-infrared light irradiated to the living tissue 15 is diffusely reflected in the living tissue, a part of the diffuse reflected light is received by the light receiving fiber 29 disposed at the center of the tip of the measurement probe 18. The received light is emitted from the measurement-side emitting body 20 through the light receiving fiber 29 (measuring optical fiber 16). The light emitted from the measurement-side emitting body 20 enters the diffraction grating 23 through the lens 22, is spectrally separated, and is detected by the light receiving element 24.

  The optical signal detected by the light receiving element 24 is subjected to analog-digital conversion (AD conversion) by the A / D converter 25 and then input to an arithmetic device 26 such as a personal computer. The blood glucose level is calculated by analyzing the spectrum data. In the reference measurement, the light reflected from the reference plate 27 such as a ceramic plate is measured and used as the reference light. That is, near-infrared light incident on the optical fiber bundle 14 from the halogen lamp 10 is applied to the surface of the reference plate 27 from the tip of the reference probe 19 through the reference optical fiber 17A.

  The reflected light of the light irradiated on the reference plate 27 is received by the light receiving fiber 29 disposed at the center of the tip of the reference probe 19. The received light is emitted from the reference side emitter 21 via the light receiving fiber 29 (reference optical fiber 17B). A shutter 28 is disposed between the measurement-side emitter 20 and the lens 22 and between the reference-side emitter 21 and the lens 22, and the light from the measurement-side emitter 20 and the reference side are opened and closed by opening and closing the shutter 28. Any one of the light from the emitter 21 is selectively passed.

  As shown in FIG. 3B, the end faces of the measurement probe 18 and the reference probe 19 are composed of twelve light emitting fibers 30 arranged on a circle and one light receiving fiber 29 arranged at the center. Yes. The center distance L between the light emitting fiber 30 and the light receiving fiber 29 is, for example, 0.65 mm. The end faces of the measurement-side emitter 20 and the reference-side emitter 21 are not shown, but the exit fiber is disposed at the center.

  In this apparatus, in order to selectively measure the spectrum of the dermis part of the skin tissue, as shown in FIG. 3B, a light receiving fiber 29 is arranged at a center-to-center distance L = 0.65 mm, and the incident point and detection are detected. The skin tissue measurement probe 18 as a point is used. When spectrum measurement is performed by bringing the skin tissue measurement probe 18 into contact with the skin surface, near-infrared light irradiated from the incident optical fiber is diffusely reflected in the skin tissue, and a part of the incident light is used for detection. It reaches the optical fiber, and its light propagation path takes a path called “banana shape” and propagates around the dermis. Therefore, the SN ratio of the light absorption signal is improved, and the biological component concentration can be accurately measured.

  In the spectrum measurement performed by bringing the skin tissue measurement probe 18 into contact with the skin surface, it is necessary to create an optically good state between the living tissue and the optical fiber and to maintain the state for a long time. One effective method is to adjust the refractive index of living tissue and optical fiber to improve the light input / output state. Therefore, an air layer does not enter the interface between the optical fiber made of silica glass having a refractive index of about 1.45 and the living skin tissue having a refractive index of about 1.37, and the refractive index of both is adjusted. It is effective to use the interface member according to the present embodiment. In order to adjust the refractive index of the incident optical fiber, the detection optical fiber, and the living skin tissue, it is desirable to use a material having a refractive index of 1.3 to 1.6, and the properties thereof are a rigid optical fiber and a soft body. Therefore, a flexible resin having elastic properties such as rubber is desirable.

  Conventionally, liquids such as mineral oil have been used to adjust the refractive index. However, liquids such as mineral oil swell into living tissues or flow out on the surface to maintain a constant state for a long time. Therefore, it is difficult to apply to an application that continuously measures several hours such as blood glucose level monitoring of this embodiment.

  The optical blood glucose level measurement system used in the present embodiment is most preferably one that measures the diffuse reflection spectrum of skin tissue with near infrared light having a wavelength of 1300 nm to 2500 nm. The wavelength region of near-infrared light is in the range of 800 to 2500 nm, but a wavelength of 1300 to 2500 nm is appropriate for measurement of skin tissue. This is because there is a difference in characteristics when propagating through a living body, depending on the wavelength in the near infrared region. That is, the absorption intensity is small at wavelengths shorter than 1300 nm, and the propagation distance of light in this wavelength region is several centimeters, which is not suitable for the measurement of skin tissue having a thickness of about 1 mm at most. Since the absorption intensity is large at wavelengths longer than 1300 nm and the propagation distance of light in this wavelength region is several mm, it is suitable for measurement of living skin tissue having a thickness of about 1 mm.

  Here, the tissue in which the estimated blood glucose level is easily measured in the body tissue is a skin tissue. In particular, blood vessels develop in the dermal tissue of the skin tissue, and blood glucose quickly diffuses into the skin tissue, so that the glucose concentration in the skin tissue is substituted for the glucose concentration in the blood vessel (ie, blood glucose level). Can be used as

  More specifically, the skin tissue of a living body is mainly composed of three layers of tissues, an epidermis tissue, a dermis tissue, and a subcutaneous tissue. The epidermal tissue is a tissue including the stratum corneum, and the capillaries are not so developed in the tissue. The subcutaneous tissue is mainly composed of adipose tissue. Therefore, it is considered that the correlation between the water-soluble biological component concentrations contained in the two tissues, in particular, the glucose concentration and the blood glucose concentration (blood glucose level) is low. On the other hand, for the dermal tissue, since the capillaries are developed and the highly water-soluble biological component, particularly glucose, has high permeability in the tissue, the concentration of the biological component, particularly glucose concentration is interstitial fluid (ISF). : Interstitial Fluid) is considered to change following the blood glucose level. Therefore, if spectrum measurement targeting the dermal tissue is performed, a spectrum signal correlated with blood glucose level fluctuation can be obtained.

  As described above, when near infrared light having a wavelength of 1300 nm to 2500 nm is used, the distance between the centers of the light emitting part (light emitting fiber 30) and the light receiving part (light receiving fiber 29) is set to 0.65 mm. It is preferable to perform near-infrared spectrum measurement by bringing the probe into contact with the skin. In this case, the near-infrared light irradiated from the light emitting unit is irradiated to the skin tissue from the irradiation surface, diffusely reflected in the skin tissue, and a part thereof reaches the light receiving unit. The light propagation path at this time propagates through the skin tissue centering on the dermis layer and takes a shape called “banana shape”, enabling selective measurement in the depth direction of the skin tissue, and accuracy. Good measurement.

  It is necessary to stably measure a qualitatively good measurement spectrum from the start to the end of the measurement as a condition for accurately performing blood glucose level monitoring over a long time of several hours from the start to the end of the measurement. Needless to say.

  Next, the measurement of the component concentration in the living body by fixing the measuring probe 18 to the surface of the living body using the interface member according to the present embodiment in the optical blood sugar level measuring system will be described in detail with reference to examples.

Example 1
Example 1 is an example of an interface member in which the measurement probe 18 is fixed to the surface of a living body when monitoring the glucose concentration (blood glucose level) in the living body.

As shown in FIG. 1, the interface member in which the measurement probe 18 used in Example 1 is fixed to the surface of a living body is a square member having a side of 3 cm and has a base member 31 having a thickness of 100 μm that holds and holds an optical probe. The optical characteristic matching portion 32 (area 28.26 mm ² ) having a diameter of 6 μm and a thickness of 20 μm formed in a position corresponding to the light irradiation portion or the detection portion of the base member 31 is integrally formed. .

  The material of the optical property matching portion 32 has an elastic property mainly composed of acrylic rubber, and its refractive index is 1.46. A release paper 33 is covered on the probe sticking surface 31a side of the interface member, and a release paper 34 is covered on the biological sticking surface 31b side, and a position 35 corresponding to the optical characteristic matching portion 32 of the release paper 34 on the biological sticking surface 31b side. Is transparent.

  The optical characteristic matching portion 32 in Example 1 is 20 μm thick, but it is better to be thin in order to minimize the influence on the optical signal, preferably 50 μm or less, and more preferably 20 μm or less. However, in order to ensure the mechanical strength of the optical property matching portion 32, a thickness of 5 μm or more is suitable.

  In addition, the optical characteristic matching portion 32 is made of acrylic rubber having a refractive index of 1.46 as a main component in Example 1, but can be stretched to a thickness of about 5 μm to about 50 μm and is flexible (elastic characteristics). ) Can be used. The material of the optical property matching portion 32 may be any material having a refractive index of 1.3 or more and 1.6 or less. For example, nitrile rubber, silicone rubber, ethylene propylene rubber, acrylic rubber, urethane rubber, fluorine-based material Rubber or chloroprene rubber can be used.

  As shown in FIG. 2, the optical probe (measurement probe) of Example 1 is a square having a side of 3 cm fixed to the skin tissue measurement probe 18 and the tip of the skin tissue measurement probe 18 having a diameter of 6 mm. The support portion 36 is shaped and is fixed to the surface of the living body skin by the interface member of the first embodiment.

  In order to attach the interface member to the optical probe, the release paper 33 on the probe attaching surface 31a side is peeled off and attached to the lower surface of the optical probe (measurement probe). At that time, the optical characteristic matching portion 32 is located at the same position as the skin tissue measurement probe 18 through the transparent portion 35 of the release paper 34 on the living body affixing surface 31b side, and the skin tissue measurement probe 18 is firmly attached. Make sure that it sticks to the tip of the. Thereafter, the release paper 34 on the side of the living body sticking surface 31b is peeled off and attached to the skin surface on the inner side of the forearm.

The blood glucose level measurement experiment for verifying the effect of the interface member in Example 1 was performed according to the following procedure.
(1) An optical probe is attached to the skin surface, and a near-infrared absorbance spectrum measurement is performed at intervals of 5 minutes, and a blood glucose level by blood sampling is measured at the timing.
(2) Using the absorbance spectrum measured 45 minutes after mounting as a reference spectrum, create a spectrum data set.
(3) A calibration model is created by multivariate analysis of the created spectral data set in the wavelength range from 1430 nm to 1850 nm. PLS regression analysis was used for multivariate analysis. Next, the estimated blood glucose level obtained by substituting the initial absorbance spectrum into the calibration model is calibrated so as to match the actual blood glucose level obtained by blood sampling. The blood glucose level measured by the absorbance spectrum measured before and after that is obtained as a change value from the calibrated blood glucose level.
(4) The blood glucose level for 45 minutes is estimated retroactively until calibration, and the post-calibration blood glucose level estimation by near-infrared absorbance spectrum measurement is repeated at 5-minute intervals.
(5) An oral glucose load is performed 1 hour and 30 minutes after the start of the absorbance spectrum measurement, and the blood glucose level of the subject is varied. For the oral glucose load, a liquid nutritional drink (Otsuka Pharmaceutical Co., Ltd. Calorie Mate (registered trademark)) was used.
(6) Measurement of absorbance spectrum and measurement of blood glucose level by blood sampling were carried out for about 4 hours after the start of measurement.

  The estimation result of the blood glucose level in Example 1 is shown in FIG. FIG. 4 shows the estimated blood glucose level estimated from the near-infrared spectrum with respect to the actual blood glucose level obtained by blood sampling, and an error bar indicating ± 20% error is displayed on the actual blood glucose level. The blood sugar level estimation by the method shown in Example 1 was as good as an estimated blood sugar level of 85% and a correlation coefficient of 0.89 indicating an error within ± 20%. In particular, it is characterized by stable blood sugar level estimation from the start of measurement, indicating that stable spectrum measurement can be performed from the start to the end of measurement by the interface member.

  As a comparative example of the first embodiment, the base member 31 of the interface member used in the first embodiment is of the same shape and material, and is the same as the first embodiment in which the optical characteristic matching portion 32 is hollow. The experiment was performed on the same subject. The result is shown in FIG. FIG. 5 shows the estimated blood sugar level estimated from the near-infrared spectrum with respect to the blood sugar level obtained by blood sampling as in FIG. The blood sugar level estimation by the method shown in this comparative example was a result that the estimated blood sugar level showing an error within ± 20% was 75% and the correlation coefficient was 0.78. In particular, it is characterized by a large estimation error at the start of measurement. This indicates that since the interface member is not used, the optical characteristics of the tip of the optical probe and the skin surface at the start of measurement are poorly matched and are not stable in a short time. In devices such as blood glucose level monitoring, there are uses that require immediate measurement start such as emergency lifesaving, and the realization of a measurement method capable of stable measurement from the start of measurement is a great practical advantage.

  Possible causes of the unstable absorbance spectrum at the start of measurement are as follows. In the comparative example, the optical characteristic matching portion 32 is hollow, and light is input / output while the skin surface and the optical probe are in direct contact. The most unstable part of such a measurement system is the skin surface of the living body. The skin surface of a living body is usually covered with a stratum corneum, and has large individual differences such as water content and surface condition, and daily differences. Simply contacting the skin surface with an optical probe at the start of absorbance spectrum measurement is greatly affected by changes in the air layer and stratum corneum water content that occur in the skin surface structure (skins and dermis). Large and the absorbance spectrum is not stable. On the other hand, by using the interface member as shown in Example 1, it is possible to eliminate the air layer generated in the skin surface structure (skin groove, hide skin), and to reduce the influence of scattering and absorption due to changes in the amount of keratin moisture. Conceivable.

When the optical probe support used in Example 1 is removed from the tip of the optical probe after completion of the absorbance spectrum measurement, the problem is the weak mechanical strength of the optical property matching portion 32. The optical characteristic matching unit 32 is preferably thin in order to reduce the influence on the optical signal as much as possible. However, if the optical characteristic matching unit 32 is thin, the mechanical strength becomes weak, and the optical characteristic matching unit 32 is removed when the optical probe support is removed from the tip of the optical probe. If the optical probe 18 is torn and caught at the tip of the optical probe 18, it takes extra work time, and if there is a possibility that the biological side surface of the optical property matching unit 32 has contacted the optical probe 18, Due to problems, it is necessary to perform disinfection operations with alcohol or the like. In particular, it is necessary to strictly manage hygiene in cases where blood glucose levels are measured using the same optical probe 18 for an unspecified number of users, and the optical characteristic matching unit 32 is located at the tip of the optical probe 18. It is absolutely necessary to prevent tearing. In order to compensate for the weak mechanical strength of the optical characteristic matching section 32, the area of the optical characteristic matching section 32 in contact with the optical probe 18 is reduced and the mechanical strength of the surrounding base member 31 is utilized. It is effective to improve the relative mechanical strength, and it is desirable that the area is not less than the area of the optical probe to be in contact and not more than 64 mm ² . In Example 1, the area is a circular shape with a diameter of 28.26 cm ^{2 and} a diameter of 6 mm so that not only the area is reduced but also the direction of mechanical strength is not given when the shape is peeled off.

(Example 2)
Example 2 is an example of an interface member in which a measurement probe is fixed to the surface of a living body when monitoring the glucose concentration (blood glucose level) in the living body as in Example 1.

  As shown in FIG. 6, the measurement probe 18 used in Example 2 is held by a support portion 36 that fixes and holds the optical probe 18 in a cylindrical shape (height 8 mm) with a bottom surface of 3 cm in diameter. The base member 31 of the interface member used in Example 2 has a cylindrical structure in which the opposite side of the bottom surface (biological adhesive surface) 31b is open, and a part of the bottom surface of the cylindrical structure or the entire bottom surface is the optical structure. This is a characteristic matching unit 32. The interface member in which the measurement probe used in Example 2 is fixed on the surface of the living body is an interface member having a cylindrical base member 31 having a diameter of 3.1 cm (having a height of 8 mm) and having a sticky side surface. No. In other words, the interface member and the support portion 36 can be fitted by the outer diameter of the support portion 36 and the size of the inner diameter of the interface member approximately matching each other.

The interface member according to the second embodiment is provided with a base member 31 having a thickness of 100 μm, and an optical characteristic matching unit having a circular shape with a diameter of 7 mm and a thickness of 20 μm, which is provided at a position corresponding to the light irradiation portion or the detection portion of the base member 31. 32 (area 38.47 mm ² ). The material of the optical characteristic matching portion 32 has an elastic characteristic whose main component is acrylic rubber, and its refractive index is 1.46. The interface member is covered with a release paper (not shown) on the side of the biological application surface 31b, and the position corresponding to the optical characteristic matching portion 32 of the release paper 34 on the side of the biological application surface 31b is transparent. The optical characteristic matching unit 32 in Example 2 was 20 μm thick.

  As shown in FIG. 6, the interface member of Example 2 is attached to the optical probe (measuring probe) so as to fit the interface member. Through the transparent portion 35 of the release-side release paper 34, the optical characteristic matching portion 32 is located at the same position as the skin tissue measurement probe 18, and is firmly attached to the distal end portion of the skin tissue measurement probe 18. Make sure. Thereafter, the release paper on the side of the living body surface is peeled off and attached to the skin surface on the inner side of the forearm.

  As described above, the base member 31 of the interface member constitutes the distal end portion of the cylindrical structure, and a portion of the distal end portion is an optical characteristic matching portion and the other end portion is opened. It is possible to make the optical characteristic matching portion coincide with the distal end portion of the skin tissue measurement probe without strict alignment by simply attaching the interface member to the probe (measurement probe) 18.

  Using the interface member in Example 2, blood glucose level monitoring was performed using the same apparatus and method as in Example 1. As in Example 1, the obtained results showed a stable absorbance spectrum over several hours from the start to the end of the experiment, and the estimated blood glucose level was stable from the start of measurement.

(Example 3)
Example 3 relates to an interface member peeling mechanism including an interface member and a reinforcing adhesive member (not shown) that mechanically reinforces the optical property matching portion 32. The interface member used in Example 1 It is composed of a reinforcing adhesive member attached thereto.

  The reinforcing adhesive member may be in the form of a sheet, or may be a solid having various shapes. The reinforcing adhesive member has an adhesiveness with the interface member that is stronger than the adhesiveness between the optical property matching portion 32 and the optical probe 18, so that the optical property matching portion 32 is broken at the tip of the optical probe 18. , It will not get stuck.

  When blood glucose level monitoring is illustrated as Example 3, blood glucose level monitoring is performed in the same manner as in Example 1. The characteristic of the third embodiment is that the optical probe 18 is peeled off from the interface member after the measurement is completed. The reinforcing adhesive member is attached to the optical characteristic matching portion 32 before the peeling. The optical characteristic matching portion 32 is mechanically reinforced and the optical probe is peeled from the interface member.

  In this way, the mechanical strength of the optical property matching portion 32 is mechanically reinforced and then the interface member is peeled to cover the weak mechanical strength of the optical property matching portion 32, and the interface member is removed from the tip of the optical probe 18. At this time, it is possible to eliminate such a situation that the optical characteristic matching portion 32 is broken and caught at the tip of the optical probe 18. For this reason, the optical characteristic matching section 32 is not torn or caught at the tip of the optical probe, and it is not necessary to perform a disinfection operation with alcohol or the like due to hygiene problems.

(Other embodiments)
As described above, the present invention has been described according to the embodiment. However, it should not be understood that the description and drawings constituting a part of this disclosure limit the present invention. From this disclosure, various alternative embodiments, examples and operational techniques should be apparent to those skilled in the art.

  For example, the optical probe in the embodiment has been exemplified for the measurement probe in which the irradiation light and the detection light are integrated, but the present invention is not limited to this, and the optical probe only for the light irradiation, the light detection Only an optical probe may be used.

  Thus, it should be understood that the present invention includes various embodiments and the like not described herein. Therefore, the present invention is limited only by the invention specifying matters in the scope of claims reasonable from this disclosure.

DESCRIPTION OF SYMBOLS 1,24 ... Light receiving element 2 ... Light emitting element 3 ... Surgical tape 4 ... Release paper 6 ... Finger 7 ... Double-sided tape 9 ... End of receiving / emitting optical fiber 10 ... Halogen lamp 11 ... Heat shielding plate 12 ... Pinhole 13 ... Lens 14 ... Optical fiber bundle 15 ... Biological tissue 16 ... Optical fiber for measurement 17A, 17B ... Optical fiber for reference 18 ... Optical probe (probe for measurement)
DESCRIPTION OF SYMBOLS 19 ... Reference probe 20 ... Measurement side emitting body 21 ... Reference side emitting body 22 ... Lens 23 ... Diffraction grating 25 ... Converter 26 ... Arithmetic device 27 ... Reference plate 28 ... Shutter 29 ... Light receiving fiber 30 ... Light emitting fiber 31 ... Base member 31a ... Probe attachment surface 31b ... Biological attachment surface 32 ... Optical characteristic matching part 33, 34 ... Release paper 36 ... Support part

Claims (9)

An interface member used for fixing an optical probe for irradiating or detecting light to a living body on the surface of the living body,
A base member having adhesiveness on both sides of a probe sticking surface for fixing and holding the optical probe and a biological sticking surface to be fixed to the surface of the living body;
Provided at a position corresponding to the light irradiating part or detecting part of the base member, having a thickness of 5 μm to 50 μm, a refractive index of 1.3 to 1.6, and the optical probe and the living body An interface member characterized in that the base member and the optical property matching part are integrally formed.   2. The interface member according to claim 1, wherein the base member is a rectangular plane having a side of 4 cm or less, a circle having a diameter of 4 cm or less, or an elliptical plane having a minor axis length of 4 cm or less.   2. The base member according to claim 1, wherein the base member has a cylindrical structure in which opposite sides of the bottom surface are open, and a part of the bottom surface of the cylindrical structure or the entire bottom surface is the optical characteristic matching portion. Interface member. 4. The interface member according to claim 1, wherein an area of the optical property matching portion is 64 mm ² or less.   The said biological sticking surface is covered with release paper, The position corresponding to the said optical characteristic matching part of the said release paper is at least transparent, The any one of Claims 1-4 characterized by the above-mentioned. Interface member.   The interface member according to claim 5, wherein the shape of the transparent portion of the release paper matches the shape of the tip portion of the optical probe.   The interface member according to claim 1, wherein the optical property matching portion is a flexible resinous sheet.   The material of the optical property matching portion is made of flexible nitrile rubber, silicone rubber, ethylene propylene rubber, acrylic rubber, urethane rubber, fluorine rubber, or chloroprene rubber. The interface member according to item 1. The interface member according to any one of claims 1 to 8,
An interface that is attached to the optical property matching portion of the interface member and mechanically reinforces the optical property matching portion, and is used when peeling the optical probe from the interface member Member peeling mechanism.

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