JP2011110083A - Skin tissue measuring probe - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a skin tissue measuring probe making the change of optical characteristics hardly occur in the skin tissue by suppressing the effect of the body movement and stabilizing the contact state between the skin tissue measuring probe and the skin. <P>SOLUTION: The skin tissue measuring probe is for measuring optical signals of the skin tissue by bringing a probe 33, the distal end of an optical fiber bundle 32, into contact with the skin surface 31 and irradiating the skin with near infrared light from the probe 33. The skin tissue measuring probe has an attachment assisting member 36 for attaching a fixing part 34 for holding the probe 33 to a measuring position in the skin. The attachment assisting member 36 extends as a flexible attaching member in the vertical and lateral directions with the fixing part 34 as the center, and is attached to the skin surface 31 by a double-sided adhesive tape 46. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention irradiates skin tissue of a living body with near-infrared light, receives diffuse reflection or transmitted light from the skin tissue, measures a signal from the obtained skin tissue, The present invention relates to a biological component sensing technique for performing quantitative analysis. In particular, the present invention relates to a skin tissue measurement probe that measures a skin tissue spectrum in a blood glucose level monitoring device that measures a blood glucose level of a living body using a change in glucose concentration in the skin tissue as a substitute characteristic.

  Regarding blood glucose level monitoring or blood glucose level monitoring, there was a higher need for blood glucose level management in diabetics than before, but in recent years, the mortality rate has been reduced by managing blood glucose levels within an appropriate range in the intensive care unit (ICU). Medical effects such as a decrease in the incidence of complications have been medically verified, and their application fields are expanding.

  The blood glucose level is measured by using an invasive method (enzyme electrode method: GOD method, GDH method, enzyme colorimetric method: HX method, etc.) that uses the collected blood and quantifies it using an enzyme reaction such as glucose oxidase. The blood pressure level can be roughly classified into non-invasive techniques 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.

  As measuring devices, not only large-scale devices for clinical tests but also portable blood glucose meters using invasive techniques are widely used for self-blood glucose measurement (SMBG) in diabetic patients. Puncture with a lancet and collect about 1 drop of blood to measure blood glucose level. The reliability of blood glucose measurement by such blood collection is high, and the measurement error is 10% or less in most models that are commercially available even for portable blood glucose meters used for self blood glucose measurement.

  Various methods have been proposed for non-invasive estimation of blood glucose levels, but there are still problems with estimation accuracy and reliability. At this point, Japan's regulatory approval and US FDA approval There is no product obtained. Among the proposed methods, the method using near infrared light is the most known. The method of non-invasively measuring blood glucose levels with near-infrared light qualifies the living tissue from signals and spectra obtained by irradiating the living tissue with near-infrared light and measuring the light diffusely reflected inside the living tissue.・ Perform quantitative analysis.

  As an example, a technique for measuring a blood glucose level from a near-infrared spectrum obtained from a living tissue as disclosed in Patent Document 1 has been proposed. FIGS. 9A and 9B show a non-invasive optical blood glucose level measuring system disclosed in Patent Document 1, in which near-infrared light emitted from the halogen lamp 1 is a heat shielding plate 2. The light enters the living tissue 6 through the pinhole 3, the lens 4, and the optical fiber bundle 5.

  One end of the measurement optical fiber 7 and one end of the reference optical fiber 8 are connected to the optical fiber bundle 5. One end of the measurement optical fiber 7 is connected to the skin tissue measurement probe 9, and the other end of the reference optical fiber 8 is connected to the reference probe 10. Furthermore, the skin tissue measurement probe 9 and the reference probe 10 are connected to the measurement-side emitter 11 and the reference-side emitter 12 via the optical fiber 7, respectively.

  When near-infrared spectrum measurement is performed by bringing the tip of the skin tissue measurement probe 9 into contact with the surface of a living tissue 6 such as the forearm of a human body, near-infrared light incident on the optical fiber bundle 5 from the halogen lamp 1 is The inside of the optical fiber bundle 5 is transmitted. Near-infrared light is applied to the surface of the living tissue 6 from 12 light emitting fibers 20 arranged concentrically from the tip of the skin tissue measurement probe 9 as shown in FIG. 9B.

  The measurement light applied to the living tissue 6 is diffusely reflected in the living tissue 6, and then a part of the diffuse reflected light is received by the light receiving fiber 19 arranged at the center of the tip of the skin tissue measuring probe 9. The received light is emitted from the measurement-side emitting body 11 through the light receiving fiber 19. The light emitted from the measurement-side emitting body 11 enters the diffraction grating 14 through the lens 13, and after being split, is detected by the light receiving element 15.

  The optical signal detected by the light receiving element 15 is AD converted by the A / D converter 16 and then input to the arithmetic device 17 such as a personal computer. The blood glucose level is calculated by analyzing the spectrum data. In the reference measurement, light reflected from a reference plate 18 such as a ceramic plate is measured, and this is used as reference light. That is, near-infrared light incident on the optical fiber bundle 5 from the halogen lamp 1 is irradiated to the surface of the reference plate 18 from the tip of the reference probe 10 through the reference optical fiber 8.

  The reflected light of the light irradiated on the reference plate 18 is emitted from the refanless emitter 12 through the light receiving fiber 19 disposed at the center of the tip of the reference probe 10. Shutters 22 are disposed between the measurement-side emitter 11 and the lens 13 and between the refanless emitter 12 and the lens 13, respectively. Then, by opening and closing the shutter 22, either the light from the measurement side emitter 11 or the light from the refanless side emitter 12 is selectively passed.

  The end surfaces of the skin tissue measurement probe 9 and the reference probe 10 are twelve light emitting fibers 20 arranged on a circle as shown in FIG. 9B and one light receiving fiber 19 arranged at the center thereof. It is configured. The center distance L between the light emitting fiber 20 and the light receiving fiber 19 is 0.65 mm. The end faces of the measurement-side emitter 11 and the reference-side emitter 12 are not shown, but the exit fiber is arranged 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. 9B, a light receiving fiber 19 is disposed at a center-to-center distance L = 0.65 mm, and the incident point and detection are detected. The skin tissue measuring probe 9 is used as a point. When the skin tissue measurement probe 9 is brought into contact with the skin surface and spectrum measurement is performed, the near-infrared light irradiated from the incident optical fiber is diffusely reflected in the skin tissue, and a part of the incident light is detected light. It reaches the fiber, and its light propagation path is called a 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.

  Further, as a conventional skin tissue measurement probe, there is a structure disclosed in Patent Document 2, for example. The probe for skin tissue measurement includes a support for the tip of the optical fiber bundle that supports the tip of the optical fiber bundle and maintains contact with the skin surface, and a tip of the optical fiber bundle that is provided on the support. And a drive means for holding the contact surface between the tip and the skin surface within a range of −150 μm to 500 μm from the surface position of the living tissue when no load is applied. It is said.

JP 2006-87913 A JP 2008-104838 A

  Non-invasive and non-invasive methods for estimating blood glucose levels regardless of blood sampling are capable of measuring blood glucose levels without imposing a burden on patients. Various measurement methods have been proposed. However, there are still problems in estimation accuracy and reliability, and at this point, there are no products that have obtained Japanese regulatory approval or US FDA approval.

  In addition, in non-invasive blood glucose level measurement using near-infrared light targeted by the present invention, there are still problems in estimation accuracy and reliability, but it is under measurement as one factor that reduces estimation accuracy and reliability. There is a change in the contact state between the skin tissue measurement probe 9 and the skin due to body movement.

  In particular, when blood glucose level measurement is continuously performed, it is necessary to appropriately set the contact state between the skin tissue measurement probe 9 and the skin and stabilize the contact state so as not to change. However, when the skin tissue measurement probe 9 is attached to a living body, particularly a site such as an extremity or an abdomen, the contact surface is a flexible tissue having a curved surface, and thus is easily affected by body movement and is difficult to stabilize the contact state. . The change in the contact state changes the optical characteristic value of the skin tissue, greatly affects the predicted value of the blood glucose level, and becomes a large error.

  Therefore, the present invention provides a skin tissue measurement probe capable of stabilizing the contact state between the skin tissue measurement probe and the skin by suppressing the influence of body movement and making it difficult to cause changes in the optical characteristics of the skin tissue. The purpose is to provide.

  The invention according to claim 1 is a skin tissue measurement in which an optical signal of a skin tissue is measured by fixing a tip portion of an optical fiber bundle to the skin surface and irradiating the skin with near infrared light from the tip portion. A probe for contacting the light receiving and emitting fiber perpendicularly to the skin surface, a fixing portion disposed around the tip, and a tip of the optical fiber bundle. A driving mechanism for driving in a direction approaching and moving away from the skin; and a mounting auxiliary member for mounting the fixing unit on the measurement site of the skin, the mounting auxiliary member being formed as a flexible mounting member, It has an adhesive means that can be repeatedly applied to the skin on the side facing the skin surface.

  Invention of Claim 2 is a probe for skin tissue measurement of Claim 1, Comprising: The said mounting assistance member is each extended and provided in the up-down and left-right direction centering | focusing on the said fixing | fixed part. It is characterized by.

  A third aspect of the present invention is the skin tissue measurement probe according to the first or second aspect, wherein the mounting assisting member is detachable from the fixing portion.

  The invention according to claim 4 is the skin tissue measurement probe according to any one of claims 1 to 3, wherein the bending end portion of the optical fiber bundle that is bent backward from the tip portion is provided. A fixing means for fixing to the mounting auxiliary member is provided.

  Invention of Claim 5 is a probe for skin tissue measurement of Claim 4, Comprising: The said fixing means is attached to the 1st fixing member attached to the said optical fiber bundle, and the said mounting auxiliary member, It consists of a 2nd fixing member which makes this 1st fixing part detachable.

  Invention of Claim 6 is a probe for skin tissue measurement of any one of Claim 1-5, Comprising: The said adhesion | attachment means is the gel form which can be repeatedly affixed with respect to the said skin It consists of a substance.

  A seventh aspect of the present invention is the skin tissue measurement probe according to any one of the first to sixth aspects, wherein one electrode is provided on the contact surface side of the attachment assisting member with the skin. And the tip of the optical fiber bundle is used as a conductive member and the tip is used as the other electrode, and the contact between the tip of the optical fiber bundle and the skin is detected by detecting the state of conduction between the two electrodes. A detection means is provided.

  The invention according to claim 8 is the skin tissue measurement probe according to claim 7, characterized in that it has a display means that lights up when a current flows between the electrodes.

  According to the probe for skin tissue measurement according to claim 1, the attachment assisting member for attaching the fixing portion to the measurement site of the skin is a flexible attachment member, so that the fixing portion is moved by body movement (the body moves). The flexible mounting assisting member absorbs the fluctuation transmitted to. Therefore, in this invention, the contact state of the front-end | tip part of the optical fiber bundle provided in the fixing | fixed part and the skin surface can be stabilized. As a result, the influence on the contact state between the probe, which is the tip of the optical fiber bundle, and the skin surface can be reduced. Therefore, the change in the optical characteristic value of the skin tissue can be reduced, and the prediction error of the blood glucose level estimated from the measured near-infrared spectrum can be reduced. In addition, since the attachment assisting member is provided with an adhesive means that can be repeatedly applied to the skin, the attachment assisting member can be applied to the skin any number of times, and even if the attachment position is shifted, Can be pasted again.

  According to the probe for measuring skin tissue according to claim 2, since the attachment auxiliary members are provided extending in the vertical and horizontal directions with the fixing portion as the center, the fixing portion is particularly attached to the skin surface portion such as the four branches and the abdomen. When attaching a wearable body, each attachment assisting member extending in the vertical and horizontal directions is in close contact with a living body part which is a soft tissue having a curved surface, so that the plurality of attachment assisting members are transmitted to the fixed part by body movement. To absorb fluctuations.

  According to the probe for measuring skin tissue according to claim 3, since the mounting auxiliary member is detachable from the fixed portion, the operation of disinfecting and cleaning the mounting auxiliary member every time measurement is facilitated. Preparation time can be shortened. In addition, if the wearing support member is made disposable, it is not necessary to check the condition of the flexible material that easily deteriorates over time due to the patient's sweat, medical drugs, etc., and those who have no expertise or inexperience in this device. Even so, appropriate measurement preparations can be made.

  According to the skin tissue measurement probe of claim 4, since the bending end portion of the optical fiber bundle bent backward from the distal end portion is fixed to the mounting auxiliary member by the fixing means, the optical fiber bundle is caused by body movement or the like. The force applied to the optical fiber bundle is attenuated by the fixing means, and is difficult to be transmitted to the tip of the optical fiber bundle.

  According to the skin tissue measurement probe of claim 5, the first fixing member attached to the optical fiber bundle and the second fixing member attached to the mounting auxiliary member and detachably attached to the first fixing member are fixed. Since the means is configured, the optical fiber bundle that is easily affected by body movement can be fixed by attaching the first fixing member to the second fixing member during measurement. On the other hand, except for the time of measurement, the first fixing member can be detached from the second fixing member to release the fixing of the optical fiber bundle.

  According to the probe for measuring skin tissue according to claim 6, since the adhesive means is a gel-like substance that can be repeatedly attached to the skin, the property of the gel-like substance that can be repeatedly attached allows the measurement at the time of measurement preparation. Redoing is easy and reliable measurement preparation can be performed.

  According to the skin tissue measurement probe of claim 7, one electrode is provided on the contact surface side of the attachment assisting member with the skin, the tip of the optical fiber bundle is used as a conductive member, and the tip is used as the other electrode. And a detecting means for detecting the contact between the tip of the optical fiber bundle and the skin by detecting the energized state between these two electrodes, the contact between the tip of the optical fiber bundle and the skin is detected by this detecting means. It can detect electrically and can stabilize the contact state of these front-end | tip parts and skin.

  According to the probe for skin tissue measurement according to claim 8, since the display means that is turned on when a current flows between both electrodes is provided, only by confirming that the display means is turned on, the tip of the optical fiber bundle And the skin contact state can be easily confirmed.

FIG. 1 is a diagram schematically showing a skin tissue measured with a probe for skin tissue measurement. 2A and 2B show a skin tissue measurement probe according to the first embodiment, in which FIG. 2A is a plan view and FIG. 2B is a cross-sectional view thereof. FIG. 3 is a view showing a living body part to which the probe for skin tissue measurement of the first embodiment is attached. 4A and 4B show a skin tissue measurement probe according to the second embodiment, in which FIG. 4A is a plan view and FIG. 4B is a cross-sectional view thereof. FIG. 5 shows a probe for skin tissue measurement according to the third embodiment, in which (A) is a plan view and (B) is a sectional view thereof. 6A and 6B show a skin tissue measurement probe according to a fourth embodiment, in which FIG. 6A is a plan view and FIG. 6B is a cross-sectional view thereof. FIG. 7 is a plan view of the skin tissue measurement probe of the fifth embodiment. FIG. 8 is a cross-sectional view of the skin tissue measurement probe of the sixth embodiment. 9A and 9B show a conventional skin tissue measuring apparatus, in which FIG. 9A is an overall configuration diagram and FIG. 9B is an enlarged view of a tip portion of an optical fiber bundle.

  Hereinafter, specific embodiments to which the present invention is applied will be described in detail with reference to the drawings.

  In order to non-invasively estimate the blood glucose level, the optical signal (diffuse reflection spectrum) of the skin tissue is measured by irradiating the skin with near infrared light having a wavelength of 1300 nm to 2500 nm as described above. Can be estimated. As shown in FIG. 1, the living skin tissue is roughly composed of three layers of an epidermal tissue S1, a dermal tissue S2, and a subcutaneous tissue S3.

  The epidermal tissue S1 is a tissue including the stratum corneum, and the capillaries are not so developed in the tissue. The subcutaneous tissue S3 is mainly composed of adipose tissue. Therefore, it is considered that the correlation between the concentration of water-soluble biological components 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 S2, the concentration of biological components in the tissue, especially the glucose concentration, is low because of the development of capillaries and the high concentration of biological components with high water solubility, particularly glucose. Like interstitial fluid (ISF), it is thought to change following blood glucose level. Therefore, if spectrum measurement targeting the dermis tissue S2 is performed, it is possible to measure a spectrum signal that correlates with biological component concentrations, particularly blood glucose level fluctuations.

  When near-infrared light having a wavelength of 1300 nm or more and 2500 nm or less is used, as shown in FIG. 1, the near-infrared spectrum skin formed by separating the light emitting unit 100 and the light receiving unit 101 from each other with a center-to-center distance L = 0.65 mm. A tissue measurement probe is brought into contact with the skin. When near-infrared spectrum measurement is performed, the near-infrared light Hv irradiated from the light emitting unit is irradiated onto the skin tissue from the irradiation surface, diffusely reflected in the skin tissue, and part of it reaches the light receiving unit. In this case, the light propagation path propagates in the skin tissue with the dermis tissue S2 as the center, and takes a shape called a banana shape. This enables selective measurement in the depth direction of the skin tissue, and accurate measurement is possible. it can.

[First Embodiment]
2A and 2B show a skin tissue measurement probe according to the first embodiment, FIG. 2A is a plan view thereof, FIG. 2B is a cross-sectional view thereof, and FIG. 3 shows a living body part to which the probe for skin tissue measurement according to the first embodiment is attached. FIG. The probe 30 for skin tissue measurement according to the first embodiment includes a probe 33 that is a tip portion of an optical fiber bundle 32 that makes a light receiving / emitting fiber vertically contact with a skin surface 31, and a fixing portion that is disposed around the probe 33. 34, a drive mechanism unit 35 for driving the probe 33 in a direction in which the probe 33 approaches and separates from the skin surface 31 (in the direction of arrow X in FIG. 2B), and a mounting aid for mounting and holding the fixing unit 34 on the skin measurement site Member 36.

  As shown in FIG. 1, the tip of the probe 33 receives a light emitting unit that irradiates near-infrared light Hv of 1300 nm or more and 2500 nm or less toward the skin surface 31 and light that is diffused and irradiated inside the skin tissue. And a light receiving portion. Since the light emitting portion and the light receiving portion have the same structure as that in FIG. 9B, description thereof is omitted here.

  The fixing part 34 functions as a base for holding the probe 33, and is formed as a base having a circular shape in plan view, for example. The fixing portion 34 is provided with a hole portion 38 for receiving a probe driving elevating member 37 (described later) for holding and fixing the probe 33 so as to be movable up and down. The hole 38 is not a through hole but a blind hole having a bottom 39. In addition, a through hole 40 for bringing the tip of the probe 33 into contact with the skin surface 31 is formed in the bottom 39.

  The drive mechanism unit 35 includes a probe driving elevating member 37 housed in a hole 38 formed in the fixing unit 34 and movable up and down, and a screw unit 41 that moves the probe driving elevating member 37 up and down. It is configured. The probe driving elevating member 37 has a rectangular shape in plan view, and is inserted into the hole 38 so as to be movable up and down. The probe driving elevating member 37 is formed with a probe insertion holding hole 42 for inserting and holding the probe 33 which is the tip of the optical fiber bundle 32. The probe driving elevating member 37 is provided with a screw hole 43 through which the screw portion 41 is attached.

  The screw portion 41 is rotated clockwise to raise the probe driving elevating member 37 and move the probe 33 held by the probe driving elevating member 37 in a direction away from the skin surface 31. On the other hand, the screw portion 41 is rotated counterclockwise to lower the probe driving elevating member 37 and move the probe 33 in a direction to approach the skin surface 31.

  As the screw portion 41, for example, one having a male screw having a pitch of 0.25 mm is used. By setting the screw portion 41 to a small screw pitch of 0.25 mm, the moving distance of the probe 33 can be precisely controlled in units of several microns. On the other hand, the probe driving elevating member 37 is formed with a screw hole 43 in which a female screw having a pitch corresponding thereto is formed. Note that the tip end portion of the screw portion 41 is always in contact with the bottom surface of the hole portion 38 formed in the fixing portion 34.

  The attachment assisting member 36 attaches and holds the fixing portion 34 to the skin measurement site, and has a cross shape extending in the vertical and horizontal directions around the fixing portion 34. The mounting auxiliary member 36 is formed as a flexible mounting member that keeps the probe 33 perpendicular to the skin surface 31 in close contact with the skin around the measurement site. The mounting auxiliary member 36 is formed of a material such as polyurethane or silicon rubber having high flexibility, for example, and is attached to the fixing portion 34 with an adhesive.

  The attachment assisting members 36 that extend in the vertical and horizontal directions around the fixing portion 34 are in close contact with a living body part, which is a soft tissue having a curved surface, due to its flexible characteristics. For example, in the case where the fixing portion 34 is mounted and held on the portion S indicated by hatching in the arm 44 shown in FIG. 3, the mounting auxiliary member 36 extending in four directions is orthogonal to the direction A extending from the elbow of the arm 44 to the wrist. It is mounted in the direction B that wraps around the arm 44, which is the direction to perform. By attaching the attachment assisting members 36 to the arms 44 in the four directions, it becomes difficult to transmit the influence of body movement to the fixing portion 34.

  An opening hole 45 for bringing the tip of the probe 33 into contact with the skin surface 31 is formed in a central portion of the mounting auxiliary member 36 having a cross shape where the fixing portion 34 is mounted. In addition, a double-sided tape 46, which is an adhesive means that can be repeatedly attached to the skin, is attached to the attachment assisting member 36 on the surface facing the skin surface 31. The double-sided tape 46 has a cross shape that is approximately the same size as the attachment assisting member 36. One adhesive surface of the double-sided tape 46 is bonded to the mounting assisting member 36, and the other adhesive surface is bonded to the skin surface 31. The double-sided tape 46 is formed with a hole 47 that allows the tip of the probe 33 to face the portion facing the opening hole 45.

  In order to measure the blood glucose level of a living body with the skin tissue measurement probe 30 of the present embodiment, an optical fiber bundle is provided along the direction A from the elbow to the wrist at the site S indicated by the oblique lines of the arm 44 shown in FIG. 32, two attachment assisting members 36 parallel to the direction A are attached to the skin surface 31 with a double-sided tape 46. Thereafter, the remaining two attachment assisting members 36 are attached to the skin surface 31 with a double-sided tape 46 so as to be wound around the arm 44. The optical fiber bundle 32 is bent (curved) so as to form an inverted U shape upward from a position where the probe 33 is attached.

  Next, the screw part 41 is rotated counterclockwise. Then, the probe 33 fixed to the probe driving elevating member 37 is lowered from the upper position to the skin surface 31. The probe 33 is lowered until the tip thereof contacts the skin surface 31. Thereafter, the screw portion 41 is rotated in the clockwise direction, and the probe 33 is held at the measurement position slightly raised from the skin surface 31. Then, near-infrared spectrum measurement is performed, in which near-infrared light is irradiated perpendicularly to the skin surface 1 from the light-emitting portion of the probe 33 held at the measurement position, and the light that is diffusely reflected in the skin tissue is received by the light-receiving portion. Do. Thereby, a blood glucose level can be estimated from the spectrum signal obtained by near infrared spectrum measurement.

  According to the skin tissue measurement probe 30 of the present embodiment, since the attachment assisting member 36 that attaches and holds the fixing portion 34 to the measurement site of the skin is a flexible attachment member, a living body site that is a soft tissue having a curved surface is measured. Even in this case, the attachment assisting member 36 sticks to the curved surface due to its flexible material characteristics, and the attachment state of the fixing portion 34 to the skin can be stabilized. In addition, according to the present embodiment, the flexible attachment assisting member 36 absorbs the fluctuation transmitted to the fixing portion 34 due to body movement, and the probe 33 that is the distal end portion of the optical fiber bundle 32 provided on the fixing portion 34 and the skin. The contact state with the surface 31 can be stabilized.

  Further, according to the skin tissue measurement probe 30 of the present embodiment, since the attachment assisting member 36 is provided extending in the vertical and horizontal directions around the fixing portion 34, the flexible material extending in four directions is used. The mounting assisting member 36 thus configured can stably hold the holding portion 34 on the skin. Moreover, it becomes difficult to transmit the influence by body movement to the fixing | fixed part 34 by each mounting | wearing auxiliary member 36 being mounted to a biological body part in four directions. As a result, the influence on the contact state between the probe 33, which is the tip of the optical fiber bundle 31, and the skin surface 31 can be reduced. Therefore, the change in the optical characteristic value of the skin tissue can be reduced, and the prediction error of the blood glucose level estimated from the measured near-infrared spectrum can be reduced.

  In particular, when the skin tissue measurement probe 30 is attached to the limbs or the abdomen, the relative positional relationship between the skin and the probe 33 is likely to fluctuate greatly due to body movement, but the flexible attachment assisting member 36 fluctuates due to body movement. Absorb and reduce the influence on the fixed portion 34. As a result, the optical characteristic value change of the skin tissue can be reduced, and the prediction error of the blood sugar level estimated from the measured near-infrared spectrum can be reduced.

  In FIG. 2, the double-sided tape 46 is used as an adhesive means for attaching the skin tissue measurement probe 30 to a living body site, but a gel pad made of a gel-like substance may be used. For example, a gel pad formed of hydrogel and polyester fiber as an intermediate substrate is used.

  If it is a gel pad, it is not necessary to use the double-sided tape 46, and it can be repeatedly applied to the skin over and over. Therefore, the skin tissue measurement probe 30 can be attached to the skin again and again, and the skin tissue measurement probe 30 can be attached to an appropriate measurement site.

[Second Embodiment]
4A and 4B show a skin tissue measurement probe according to the second embodiment, in which FIG. 4A is a plan view and FIG. 4B is a cross-sectional view thereof. In the second embodiment, only differences from the skin tissue measurement probe 30 of the first embodiment will be described, and the same components as those in the first embodiment will be denoted by the same reference numerals, and description thereof will be omitted. And

  The skin tissue measurement probe 30 according to the second embodiment has a structure in which the mounting auxiliary member 36 is detachable from the fixing portion 34. Specifically, as shown in FIG. 4, a fitting hole 48 for fitting the fixing portion 34 to the attachment auxiliary member 36 is formed by hollowing out, and the fixing portion 34 is fitted into the fitting hole 48 so as to be detachable. It is said.

  The fixing portion 34 fitted in the fitting hole 48 is mounted and held on the skin surface 31 by a double-sided tape 49 attached to the skin contact surface side. The double-sided tape 49 affixed to the fixing portion 34 and the double-sided tape 46 affixed to the mounting assisting member 36 have the same height so as not to be different. Note that a hole 50 is formed in the double-sided tape 49 to be affixed to the fixing portion 34 in order to bring the probe 33 into contact with the skin surface 31.

  According to the skin tissue measurement probe 30 of the second embodiment, since the attachment auxiliary member 36 is detachable with respect to the fixing portion 34, the operation of disinfecting and washing the attachment auxiliary member 36 for each measurement is facilitated. Preparation time can be shortened. In addition, if the mounting assisting member 36 is made disposable, it is not necessary to check the state each time a flexible material that easily deteriorates with age due to the patient's sweat or medical drugs is used. As a result, it is possible to make appropriate measurement preparations even for those who have no specialized knowledge of the present apparatus or who have little experience.

[Third Embodiment]
FIG. 5 shows a probe for skin tissue measurement according to the third embodiment, in which (A) is a plan view and (B) is a sectional view thereof. In the third embodiment, only differences from the skin tissue measurement probe 30 of the first embodiment will be described, and the same components as those in the first embodiment will be denoted by the same reference numerals, and description thereof will be omitted. And

  The skin tissue measurement probe 30 according to the third embodiment has a structure in which the bending end portion of the optical fiber bundle 32 bent backward from the distal end portion is fixed to the mounting auxiliary member 36 by a fixing means. In the vicinity of the probe 33, the optical fiber bundle 32 tends to be elongated in a direction perpendicular to the skin surface 31 so as not to bend the light receiving / emitting fiber as much as possible. However, if the optical fiber bundle 32 is made too long, the handling of the device itself becomes worse. Therefore, a bent portion 32A is formed so as to form an inverted U shape from the probe 33, which is the tip portion, upward and backward, and the bent terminal portion of the bent portion 32A is fixed to the mounting auxiliary member 36 by the fixing means 51.

  The fixing means 51 is a male member 52 that is a first fixing member attached to the bending end portion of the bent portion 32A of the optical fiber bundle 32, and is coupled to the male member 52 to fix the optical fiber bundle 32 to the mounting auxiliary member 36. And a female member 53 as a second fixing member. The fixing means 51 including the male member 52 and the female member 53 has a detachable snap button structure, for example, and is used when the optical fiber bundle 32 is fixed to the attachment auxiliary member 36 at the time of measurement. The male member 52 has a hole 54 for inserting and holding the optical fiber bundle 32.

  The position where the fixing means 51 is provided is a position within a distance L = 50 mm from the position where the probe 33 which is the tip of the optical fiber bundle 32 is provided. At this position, a female member 54 fixed to the mounting assisting member 36 is provided.

  According to the skin tissue measurement probe 30 of the third embodiment, the fixing means 51 fixes the bending end portion of the optical fiber bundle 32 bent backward from the distal end portion, so that the force applied to the optical fiber bundle 32 due to body movement or the like. Is blocked by the fixing means 51 and difficult to be transmitted to the tip of the optical fiber bundle 32. Therefore, the relative position between the probe 33, which is the tip of the optical fiber bundle 32, and the skin surface 31 can be stabilized.

  Further, according to the skin tissue measurement probe 30 of the third embodiment, since the fixing means 51 is made detachable, the handling of the optical fiber bundle 32 is facilitated, and the work of disinfecting and cleaning the attachment auxiliary member 36 is easy. become.

  The skin tissue measurement probe according to the second embodiment in which the fixing portion 34 is fitted into the fitting hole 48 in which a part of the mounting auxiliary member 36 is cut out, and the fixing portion 34 is detachable from the mounting auxiliary member 36. 30 may be applied with the fixing means 51 of the third embodiment.

[Fourth Embodiment]
6A and 6B show a skin tissue measurement probe according to a fourth embodiment, in which FIG. 6A is a plan view and FIG. 6B is a cross-sectional view thereof. In the fourth embodiment, only differences from the skin tissue measurement probe 30 of the third embodiment will be described, and the same components as those of the third embodiment will be denoted by the same reference numerals, and the description thereof will be omitted. And

  The skin tissue measurement probe 30 according to the fourth embodiment includes detection means for detecting the contact state between the probe 33, which is the distal end portion of the optical fiber bundle 32, and the skin in a state of current flowing between both electrodes, which will be described later. Structure. Specifically, one electrode 55 is provided on the contact surface side of the attachment assisting member 36 with the skin, the probe 33 which is the tip of the optical fiber bundle 32 is used as the other electrode, and the energization state between these two electrodes is determined. Detecting the contact between the probe 33 and the skin.

  One electrode 55 is provided on the mounting auxiliary member 36 that extends in any direction among the cross-shaped mounting auxiliary members 36, for example, the mounting auxiliary member 36 on the opposite side of the fixing means 51. The electrode 55 is attached so as to be embedded on the contact surface side of the attachment assisting member 36 with the skin. And the front end surface 55a of this electrode 55 is exposed to the opening hole 56 of the double-sided tape 46 where the part corresponding to this is hollowed out, and is flush with the mounting surface 46a of the double-sided tape 46.

  An external terminal 57 is attached to one of the electrodes 55. The external terminal 57 protrudes on a surface 36 a opposite to the side on which the double-sided tape 46 is attached, penetrating the mounting auxiliary member 36.

  The other electrode is formed, for example, by covering the outer peripheral portion of the probe 33 with a cylindrical member made of stainless steel.

  In order to detect the contact between the probe 33 and the skin by the detection means, a weak and constant alternating current is passed between one electrode 55 and the probe 33 which is the other electrode. Then, a current flows between the one electrode 55 and the probe 33 that are in contact with the skin surface 31 through the skin. The weak current flowing between the electrodes is detected by a detection device such as an ammeter. If the ammeter needle is shaken, it is determined that the probe 33 has contacted the skin surface 31. If the ammeter needle is not shaken, it is determined that the probe 33 is not in contact with the skin surface 31. As the AC power supply unit, for example, a unit that passes a weak current of about several tens kHz to several hundreds kHz is used.

  Note that the AC power supply unit and the detection device for confirming energization are used for initial setting work before blood sugar level measurement, and are removed when blood sugar level is measured.

  According to the skin tissue measurement probe 30 of the fourth embodiment, the contact state between the probe 33, which is the tip of the optical fiber bundle 32, and the skin is detected electrically by detecting the energization state between both electrodes. Therefore, the contact state between the tip of the probe 33 and the skin can be stabilized. As a result, inappropriate settings between the probe 33 and the skin are reduced, and the prediction error of the blood sugar level estimated from the near-infrared spectrum can be reduced.

  Further, according to the skin tissue measurement probe 30 of the fourth embodiment, since one electrode 55 is provided on the attachment auxiliary member 36, it is not necessary to separately attach an electrode to a living body, and the operation at the time of attachment is facilitated. The preparation time until blood glucose level measurement can be shortened.

  The skin tissue measurement probe according to the second embodiment in which the fixing portion 34 is fitted into the fitting hole 48 in which a part of the mounting auxiliary member 36 is cut out, and the fixing portion 34 is detachable from the mounting auxiliary member 36. The detection unit of the fourth embodiment may be applied to 30.

[Fifth Embodiment]
FIG. 7 is a plan view of the skin tissue measurement probe of the fifth embodiment. In the fifth embodiment, only differences from the skin tissue measurement probe 30 of the fourth embodiment will be described, and the same components as in the fourth embodiment will be denoted by the same reference numerals, and the description thereof will be omitted. And

  In the fourth embodiment, a detection device such as an ammeter is used as a means for detecting a current flowing between one electrode 55 and the probe 33 which is the other electrode. In the fifth embodiment, energization between both electrodes is performed. The display unit 58 that detects the state by lighting it is used. Specifically, a light source such as an LED or the like is provided as a display unit 58 on the fixing portion 34 that holds the probe 33. Note that the current passed between the two electrodes is not the alternating current used in the fourth embodiment but a direct current.

  The display means 58 is embedded in the fixed portion 34, and the display portion is exposed on the upper surface 34a. When the display means 58 is lit, it is determined that the probe 33 has contacted the skin surface 31. When the display means is not lit, it is determined that the probe 33 is not in contact with the skin surface 31.

  According to the skin tissue measurement probe 30 of the fifth embodiment, since the display means 58 that is turned on when a current flows between both electrodes is provided, the probe 33 can be simply checked simply by checking the lighting state of the display means 58. It is possible to detect the contact state between the skin and the skin. Further, according to the present embodiment, in order to check the energization state between both electrodes, it is only necessary to connect the power source to the terminal 57 and the probe 33. Therefore, the operation when attaching the skin tissue measurement probe 30 to the skin can be facilitated, and the preparation time until blood glucose level measurement can be shortened.

[Sixth Embodiment]
FIG. 8 is a cross-sectional view of the skin tissue measurement probe of the sixth embodiment. In the sixth embodiment, only differences from the skin tissue measurement probe 30 of the fourth embodiment will be described, and the same components as in the fourth embodiment will be denoted by the same reference numerals, and the description thereof will be omitted. And

  In the fourth embodiment, one electrode 55 is provided on the mounting assisting member 36. However, in the sixth embodiment, the mounting assisting member 36 itself is an electrically conductive gel pad, and the electrode 55 is omitted. Since the gel pad has a characteristic that it can be applied repeatedly any number of times, the double-sided tape 46 used in the fourth embodiment is not necessary. The mounting assisting member 36 of the sixth embodiment is a gel pad that is made conductive by adding a conductive metal to a base material made of hydrogel and polyester fiber as an intermediate base material.

  According to the skin tissue measurement probe 30 of the sixth embodiment, since the mounting assisting member 36 itself becomes one electrode, the contact area with the skin surface 31 is increased, and the contact resistance can be reduced. Therefore, the contact state between the probe 33 and the skin can be detected more accurately.

  In the skin tissue measurement probe 30 of the sixth embodiment, the display means 58 used in the fifth embodiment may be provided in the fixing portion 34. By providing the display means 58, the energization state between the two electrodes can be detected by lighting, and the contact state between the probe 33 and the skin can be detected visually.

DESCRIPTION OF SYMBOLS 30 ... Probe for skin tissue measurement 31 ... Skin surface 32 ... Optical fiber bundle 33 ... Probe (tip part of optical fiber bundle, other electrode)
34... Fixed portion 35... Drive mechanism portion 36... Mounting auxiliary member 37... Probe drive lifting member (drive mechanism portion)
41 ... Screw part (drive mechanism part)
44 ... arm (body part)
46, 49 ... Double-sided tape 51 ... Fixing means 52 ... Male member (first fixing member)
53. Female member (second fixing member)
55 ... Electrode (one electrode)
57 ... External terminal

Claims (8)

A skin tissue measurement probe for fixing an optical fiber bundle tip to the skin surface and measuring an optical signal of the skin tissue by irradiating the skin with near-infrared light from the tip,
A tip portion of the optical fiber bundle in which a light receiving and emitting fiber is brought into perpendicular contact with the skin surface;
A fixing portion disposed around the tip portion;
A drive mechanism for driving the tip of the optical fiber bundle in a direction approaching and separating from the skin;
An attachment auxiliary member for attaching the fixing portion to the measurement site of the skin,
The probe for skin tissue measurement, wherein the attachment assisting member is formed as a flexible attachment member, and has adhesive means that can be repeatedly attached to the skin on the side facing the skin surface. The probe for skin tissue measurement according to claim 1,
The attachment assisting member is provided so as to extend in the vertical and horizontal directions with the fixing portion as a center. The probe for skin tissue measurement according to claim 1 or 2,
The probe for skin tissue measurement, wherein the attachment assisting member is detachable from the fixing portion. The probe for skin tissue measurement according to any one of claims 1 to 3,
A probe for skin tissue measurement, comprising: a fixing means for fixing a bending end portion of an optical fiber bundle bent backward from the tip portion to the mounting auxiliary member. The probe for skin tissue measurement according to claim 4,
The fixing means comprises: a first fixing member attached to the optical fiber bundle; and a second fixing member attached to the attachment auxiliary member and detachably attaching the first fixing portion. Probe for measurement. The probe for skin tissue measurement according to any one of claims 1 to 5,
The probe for measuring skin tissue, wherein the adhesive means is made of a gel substance that can be repeatedly applied to the skin. The probe for skin tissue measurement according to any one of claims 1 to 6,
One electrode is provided on the contact surface side of the wearing auxiliary member with the skin, the distal end portion of the optical fiber bundle is used as a conductive member, and the distal end portion is used as the other electrode. And a detecting means for detecting contact between the tip of the optical fiber bundle and the skin. The probe for skin tissue measurement according to claim 7,
A probe for measuring skin tissue, comprising display means that lights up when a current flows between the electrodes.

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