WO2013046993A1

WO2013046993A1 - Needle sensor and needle sensor unit

Info

Publication number: WO2013046993A1
Application number: PCT/JP2012/070881
Authority: WO
Inventors: 貴平時本; 利夫深井
Original assignee: オリンパス株式会社; テルモ株式会社
Priority date: 2011-09-30
Filing date: 2012-08-17
Publication date: 2013-04-04

Abstract

The sensor (30) comprises: a main body (33); a connector (35), which is provided on the base end of the main body; and a tip (32), which is provided on the tip of the main body (33) and on which a sensor part (10) for measuring the concentration of an analyte is disposed. On at least one portion of the outer surface of the tip (32), which includes the measuring surface of the sensor part (10), a swelling layer (60) that absorbs a body fluid and swells, is provided.

Description

Needle-type sensor and needle-type sensor unit

The present invention relates to a needle-type sensor for measuring the concentration of an analyte in a body and a needle-type sensor unit having the needle-type sensor, and in particular, a short-term indwelling needle-type sensor in which a sensor unit is inserted and indwelled, and the above-mentioned The present invention relates to a needle type sensor unit having a needle type sensor.

In the needle-type sensor, when the tip of the needle is punctured into the subject, an analyte of body fluid or blood in the body, that is, a sensor unit for measuring the concentration of the substance to be measured is inserted and placed in the body. The short-term indwelling needle sensor continuously measures the concentration of the analyte in the body for a predetermined period, for example, one week.

As shown in FIG. 1, US Pat. No. 7,003336 discloses a needle-type sensor unit 101 in which a needle-type sensor 130 having a sensor portion 110 at the tip is inserted into a slot 150 that is a sheath tube. ing.

As shown in FIG. 2, the needle-type sensor unit 101 includes a sensor of the needle-type sensor 130 by removing the slot 150 from the subject 90 after the slot 150 and the needle-type sensor 130 are punctured into the subject 90. Part 110 is placed in the body.

The size D91 of the hole 91 formed in the subject 90 by puncturing the slot 150 is substantially equal to the outer dimension of the slot 150. That is, the size D91 of the hole 91 is larger than the outer dimension D110 of the needle sensor 130. For this reason, at the start of use, that is, immediately after the slot 150 is removed, the sensor unit 110 of the needle sensor 130 is not in contact with the surrounding tissue inside the hole 91. Since the hole 91 gradually contracts due to biological activity, the sensor unit 110 eventually comes into contact with surrounding tissue.

The sensor unit 110 detects an analyte by contact with a body fluid or the like that has oozed into the hole 91 even in a non-contact state with the tissue. However, it cannot be said that the non-contact state is more responsive to changes in the analyte concentration than the contact state. Further, when the position of the sensor unit 110 inside the hole 91 changes, the contact state may be temporarily changed from the non-contact state. For this reason, the needle-type sensor 130 may not be easily measured for a while from the start of use.

An object of the present invention is to provide a needle type sensor capable of performing stable measurement from the start of use and a needle type sensor unit having the needle type sensor.

The needle sensor according to one aspect of the present invention includes a main body portion, a connector portion provided on a proximal end side of the main body portion, and a sensor portion for measuring an analyte concentration provided on a distal end side of the main body portion. A swelling layer that absorbs and swells the liquid component of the subject is disposed on at least a part of the outer peripheral surface of the tip portion including the measurement surface of the sensor portion. ing.

Further, the needle-type sensor unit according to another aspect of the present invention includes a main body part, a connector part provided on the base end side of the main body part, and an analyte concentration provided on the distal end side of the main body part. A swelling layer that absorbs and swells the liquid component of the subject is disposed on at least a part of the outer peripheral surface of the tip portion including the measurement surface of the sensor portion. A needle-type sensor,
An outer dimension of the tip including the swollen swelling layer, which is punctured in the subject with the tip housed therein, and is removed while leaving the tip in the body before starting the measurement of the analyte concentration. A sheath tube having a smaller outer dimension than the outer tube.

It is a schematic diagram which shows the cross-section of the conventional needle type sensor unit. It is a cross-sectional schematic diagram for demonstrating the puncture by the conventional needle type sensor unit. It is a mimetic diagram of a needle type sensor unit which has a needle type sensor of a 1st embodiment. It is a cross-sectional schematic diagram along the IV-IV line of FIG. 3 of the needle type sensor unit having the needle type sensor of the first embodiment. It is a mimetic diagram of a sensor system which has a needle type sensor unit of a 1st embodiment. It is a cross-sectional schematic diagram for demonstrating the puncture by the needle type sensor unit of 1st Embodiment. It is a cross-sectional schematic diagram for demonstrating the puncture by the needle type sensor unit of 1st Embodiment. It is a cross-sectional schematic diagram for demonstrating the structure of the sensor part of the needle type sensor of 1st Embodiment. It is a cross-sectional schematic diagram along the VIII-VIII line of FIG. 7 for demonstrating the state of the front-end | tip part of the needle type sensor of 1st Embodiment. It is a cross-sectional schematic diagram along the VIII-VIII line of FIG. 7 for demonstrating the state of the front-end | tip part of the needle type sensor of 1st Embodiment. It is a cross-sectional schematic diagram along the VIII-VIII line of FIG. 7 for demonstrating the state of the front-end | tip part of the needle type sensor of 1st Embodiment. It is a cross-sectional schematic diagram along the VIII-VIII line of FIG. 7 for demonstrating the state of the front-end | tip part of the needle type sensor of 2nd Embodiment. It is a cross-sectional schematic diagram for demonstrating the structure of the sensor part of the needle type sensor of the modification of 2nd Embodiment.

<First Embodiment>
Hereinafter, a needle type sensor (hereinafter referred to as “sensor”) 30 and a needle type sensor unit 1 according to a first embodiment of the present invention will be described with reference to the drawings. As shown in FIG. 3, the needle-type sensor unit 1 includes a sensor 30 and a sheath tube 50 for puncturing. The sheath tube 50 is a hollow so-called outer needle having a sharp tip, and is an auxiliary tool for puncturing the subject with the sensor 30. That is, the sheath tube 50 has at least the distal end portion 32 of the sensor 30 in the hollow portion. The subject is punctured in a state in which it is accommodated. And before starting the measurement of the analyte concentration, the sensor tube 30 is left in the body and the sheath tube 50 is removed.

The sensor 30 includes a distal end portion 32, a main body portion 33 extending from the distal end portion 32, and a connector portion 35 extending from the main body portion 33. The distal end portion 32, the main body portion 33, and the connector portion 35 are produced, for example, by processing a silicon substrate. In particular, the boundary between the distal end portion 32 and the main body portion 33 may not be clear. However, for convenience, a region where the sensor unit 10 at the tip of the sensor 30 is disposed is referred to as a tip 32.

As shown in FIG. 4, the elongate sheath tube 50 has a substantially C-shaped cross section in the direction perpendicular to the major axis, and has an elongated slit in the major axis direction. In order to accommodate the sensor 30, the dimensions d50 and dW50 of the hollow portion of the sheath tube 50 are larger than the outer dimensions D32 and DW32 of the distal end portion 32, respectively.

The dimension of the hollow part and the outer dimension of the tip part 32 are cross-sectional dimensions (dimensions in plan view) in the direction perpendicular to the major axis, and the shape in plan view is a diameter in the case of a circle. When the planar view shape is substantially rectangular, the lengths are the lengths of the two sides, but for the sake of simplicity, the length of one side will be described as an example.

The measurement surface of the light shielding layer 18 (see FIG. 7) of the sensor unit 10 for measuring the analyte concentration is exposed at a part of the front surface 32 of the sensor 30. Further, the outer peripheral surface on the opposite side across the surface of the sensor portion 10 of the tip portion 32 where the light shielding layer 18 is exposed and the central axis in the major axis direction, in other words, the outer peripheral surface on the back side with respect to the measurement surface of the sensor portion 10 A swelling layer 60 is disposed on the surface. In addition, the swelling layer 60 should just be arrange | positioned at least in the said position, and may be arrange | positioned in the outer peripheral surface of the whole side surface of the front-end | tip part 32 except the measurement surface of the sensor part 10, and a back surface.

As will be described later, the swelling layer 60 swells by absorbing the liquid of the subject, that is, water in the body, but is in a dry and contracted state in a state where it is accommodated in the hollow portion of the sheath tube 50 for puncture. .

As shown in FIG. 5, the sensor 30 is used as the sensor system 2 in combination with the sensor main body 40 and the receiver 45. That is, the sensor system 2 includes a sensor 30, a sensor main body 40, and a receiver 45 that receives and stores a signal from the sensor main body 40. The connector part 35 of the sensor 30 is detachably fitted to the fitting part 41 of the sensor main body part 40. The sensor 30 is electrically connected to the sensor body 40 by mechanically fitting the connector part 35 with the fitting part 41 of the sensor body 40. Transmission / reception of signals between the sensor body 40 and the receiver 45 is performed wirelessly or by wire.

Although not shown, the sensor body 40 includes a wireless antenna for wirelessly transmitting and receiving signals to and from the receiver 45, a power source such as a battery, and various circuits for driving and controlling the sensor unit 10. Examples of the various circuits include an amplifier circuit that amplifies signals, a circuit reference clock generation circuit, a logic circuit, a data processing circuit, an AD conversion processing circuit, a mode control circuit, a memory circuit, and a communication high-frequency generator circuit. be able to. In addition, when transmitting and receiving a signal with the receiver 45 by wire, the sensor main body 40 has a signal line instead of the wireless antenna. Information such as the analyte concentration in the body fluid measured by the sensor unit 10 is stored in the memory of the receiver 45.

The sensor 30 is a disposable part that is disposed of after use to prevent infection, but the sensor body 40 and the receiver 45 are reusable parts that are repeatedly reused.

As shown in FIG. 6A, in a state where the sensor 30 is housed in the hollow portion of the sheath tube 50, the subject himself punctures from the body surface and is inserted into, for example, the dermis layer. Then, as shown in FIG. 6B, before starting the measurement of the analyte concentration, only the sheath tube 50 is removed leaving the tip 32 in the body. That is, the distal end portion 32 is left in the body.

Here, the structure of the sensor unit 10 of the sensor 30 will be described with reference to FIG. The sensor unit 10 includes a silicon substrate as a substrate 11, a photoelectric conversion element (PD element) 12, a silicon oxide layer (not shown), a filter layer 14, and a light emitting element (LED that generates excitation light and transmits fluorescence). (Element) 15, a transparent intermediate layer 16, an indicator layer 17 containing a fluorescent dye, and a light-shielding layer 18 that is the outermost layer are sequentially laminated from the substrate 11 side. Further, at least a part of each of the PD element 12, the filter layer 14, the LED element 15, and the indicator layer 17 is formed in the same region on the substrate 11. The LED element 15, the transparent intermediate layer 16, and the indicator layer 17 are accommodated inside the sensor frame 20.

In the sensor 30 shown in FIG. 7, the surface other than the light shielding layer 18 is covered with a protective layer 19 made of polyparaxylylene or the like having high biocompatibility.

On the surface of the substrate 11, a PD element 12 that converts received fluorescence into an electrical signal is formed. The substrate 11 can be thinned to about several tens of μm in the manufacturing process.

As the photoelectric conversion element, a photodiode or a phototransistor is particularly preferable. This is because the fluorescence detection sensitivity having high sensitivity and excellent stability can be realized, and as a result, the sensor unit 10 having excellent detection sensitivity and detection accuracy can be realized.

The filter layer 14 that covers the light receiving surface of the PD element 12 is, for example, an absorption optical filter that blocks the excitation light E generated by the LED element 15 and transmits fluorescence F having a longer wavelength. The filter layer 14 is preferably a silicon layer such as polycrystalline silicon, a silicon carbide layer, or a gallium phosphide layer. All of the above materials have a low transmittance at a wavelength of excitation light shorter than 375 nm and a high transmittance at a wavelength of fluorescence of 460 nm, that is, a transmittance selection of 6 digits or more as a ratio of the transmittance of excitation light to the transmittance of fluorescence. Have sex.

The LED element 15 is a light emitting element that emits excitation light and transmits fluorescence. As a light-emitting element, a sapphire substrate is used from the viewpoints of fluorescence transmittance, light generation efficiency, wide wavelength selectivity of excitation light, and little emission of light having a wavelength other than ultraviolet light serving as excitation light. A gallium nitride based ultraviolet LED is preferable.

The indicator layer 17 generates fluorescence with a light amount corresponding to the concentration of the analyte by the interaction with the entering analyte and the excitation light. The thickness of the indicator layer 17 is set to about several tens of μm. The indicator layer 17 is made of a base material containing a fluorescent dye that generates fluorescence having an intensity corresponding to the amount of the analyte, that is, the concentration of the analyte in the sample.

Any fluorescent dye can be used as long as it is selected by the analyte and the amount of fluorescent light reversibly changes in accordance with the amount of the analyte. For example, when measuring the concentration of hydrogen ions or carbon dioxide in the body, hydroxypyrenetrisulfonic acid derivatives, when measuring saccharides, phenylboronic acid derivatives having a fluorescent residue, and when measuring potassium ions, the residual fluorescence A crown ether derivative having a group can be used.

When measuring sugars such as glucose, substances that reversibly bind to glucose, such as a ruthenium organic complex, a fluorescent phenylboronic acid derivative, or a glucose binding protein modified with fluorescein, can be used as a fluorescent dye. Ruthenium and 2,2'-bipyridine, 1,10-phenanthroline, 4,7-diphenyl-1,10-phenanthroline, 4,7-dimethyl-1,10-phenanthroline, 4,7-disulfonate Complexes with diphenyl-1,10-phenanthroline, 2,2'-bi-2-thiazoline, 2,2'-bithiazole, 5-bromo-1,10-phenanthroline, 5-chloro-1,10-phenanthroline, etc. Etc. can be particularly preferably used. Furthermore, organic complexes such as osmium, iridium, rhodium, rhenium and chromium can be used instead of ruthenium in the ruthenium organic complex. In particular, a fluorescent phenylboronic acid derivative containing two phenylboronic acids and anthracene as a fluorescent residue has high detection sensitivity.

As described above, the sensor unit 10 can correspond to various uses such as an oxygen sensor, a glucose sensor, a pH sensor, an immunosensor, or a microorganism sensor by selecting a fluorescent dye.

The indicator layer 17 preferably includes a hydrogel containing or binding the fluorescent dye. For example, it is easy to contain water such as polysaccharides such as methylcellulose or dextran, acrylic hydrogel prepared by polymerizing monomers such as acrylamide, methylolacrylamide, and hydroxyethyl acrylate, or urethane hydrogel prepared from polyethylene glycol and diisocyanate. The indicator layer 17 is formed by including a fluorescent dye in the material.

The characteristics of the indicator layer 17 made of hydrogel may change with time before use in a water-containing state. For this reason, it is preferable that the indicator is in a dry state before use and in a water-containing state at the start of use. When the dried hydrogel constituting the indicator layer 17 is inserted into the body at the start of use, it absorbs a body fluid such as blood, that is, water, through the light shielding layer 18, and swells.

The light shielding layer 18 made of, for example, hydrogel containing carbon black or the like is disposed on the indicator layer 17, that is, as the outermost layer constituting the measurement surface of the sensor unit 10. The light shielding layer 18 has the property of blocking external light and excitation light, and the property of allowing analyte and water to pass through.

And the swelling layer 60 arrange | positioned by the surface on the opposite side to the sensor part 10 of the front-end | tip part 32 consists of the same hydrogel as the indicator layer 17, and is a dry state before use start.

Hydrogel swells when it absorbs water, that is, its volume increases. In other words, the hydrous hydrogel shrinks when dried. For example, a water-containing hydrogel having a polymer component of about 10% will have a volume of 50% to 10% of the water content when dried.

When the sensor 30 in a dry state is inserted into the specimen for use, the swelling layer 60 comes into contact with a body fluid that is a liquid component of the specimen, and the swelling layer 60 absorbs the body fluid and swells. .

As shown in FIG. 8, similarly to the conventional needle type sensor unit 101, the outer dimensions D50 and DW50 of the sheath tube 50 are larger than the outer dimensions D32 and DW32 of the distal end portion 32 of the sensor 30 in the needle type sensor unit 1. . Immediately after the sheath tube 50 is removed, the size of the hole 91 formed inside the subject by the sheath tube 50 is equal to the outer dimension of the sheath tube 50. For this reason, the sensor unit 10 is not in contact with the surrounding tissue inside the hole 91 and is in an unstable state.

However, as shown in FIG. 9, since the swelling layer 60 absorbs water and swells in a short time, the sensor unit 10 comes into contact with the tissue and becomes stable. That is, the sensor unit 10 including the swelling layer 60 can be accommodated in a hollow portion that is narrower than the outer dimension of the sheath tube 50 in a dry and contracted state. It becomes larger than the size.

In other words, the amount of change in the thickness of the swelling layer 60 before and after swelling is larger than the difference between the outer dimension of the sheath tube 50 and the outer dimension of the sensor unit 10.

The time required for the swelling layer 60 to swell to a predetermined size is much shorter than the time required for the pores 91 to contract due to biological activity. For this reason, for example, at the start of use after several minutes from the removal of the sheath tube 50, the sensor unit 10 comes into stable contact with the surrounding tissue.

Since the sensor unit 10 is in stable contact with surrounding tissue from the start of use, the sensor 30 can perform stable measurement. Further, the needle-type sensor unit 1 including the sensor 30 can perform stable measurement from the start of use.

In addition, the outer dimension of the front-end | tip part 32 is the distance of the surface where the light shielding layer 18 of the sensor part 10 was exposed, and the surface of the swelling layer 60, and the outer dimension of the sheath tube 50 is the longest outer dimension. For example, when the hollow portion of the sheath tube 50, the distal end portion 32, and the distal end portion 32 have a rectangular cross section, the outer dimension is the length of the long side. Further, for example, the outer dimension when the cross section is circular is the outer diameter.

The dry state of the hydrogel constituting the swelling layer 60 does not mean that the moisture content is 0 wt%. If there is a change due to swelling sufficient to close the gap between the hole 91 and the sensor unit 10, a small amount of water is required. Or a plasticizer such as glycerin. Here, the water content is the weight of hydrogel (water content 100%) which has been immersed in water for 1 hour and swollen, and the hydrogel (water content 0%) heated at 100 ° C. for 12 hours in dry air or nitrogen. %) And the weight of the hydrogel to be measured (moisture content X%). Of course, when the weight of the hydrogel excluding water is different, the correction is performed so that the hydrogel has the same weight.

For example, when the weight difference between the hydrogel having a water content of 0% and the water content of 100% is 100 mg, the water content is 30 wt% when the weight difference between the hydrogel to be measured and the hydrogel having a water content of 0% is 30 mg.

The swelling layer 60 and the indicator layer 17 of the sensor 30 before use preferably have a moisture content of 1 wt% to 25 wt%, and particularly preferably 5 wt% to 10 wt%. If it is more than the said range, the water absorption speed of the swelling layer 60 will not fall, and if it is less than the said range, while being able to perform the stable measurement from the start of use, the characteristic deterioration by the time-dependent change of an indicator can be prevented.

In the sensor 30, when the indicator layer 17 is also inserted into the body at the start of use, it absorbs water and swells. For this reason, as shown in FIG. 10, since the surface of the sensor part 10 becomes convex shape, the stable measurement can be performed in a shorter time. In addition, when the light shielding layer 18 consists of hydrogel, the light shielding layer 18 will also swell.

<Second Embodiment>
Next, a sensor 30A according to a second embodiment of the present invention will be described with reference to FIG. Since the sensor 30A of this embodiment is similar to the sensor 30 of the first embodiment, the same components are denoted by the same reference numerals, and description thereof is omitted.

As shown in FIG. 11, in the sensor 30 A of the needle-type sensor unit 1 A, the swelling layer 60 A through which the analyte can pass is disposed on the entire outer peripheral surface of the tip portion 32 A including the surface of the light shielding layer 18. .

The swelling layer 60A can be so-called dip-coated by, for example, immersing and pulling up the tip 32A of the sensor 30A in a heated hydrogel solution. Since the coated swelling layer 60A is in a water-containing state, it is dried until a desired water content is obtained.

In the sensor 30A of this embodiment, the thickness of the swelling layer 60A is half the thickness of the swelling layer 60 of the sensor 30 of the first embodiment, and has the same level of effect. For this reason, the swelling layer 60A is not only easy to form, but also rapidly expands due to water absorption. Furthermore, since the swelling layer 60A disposed on the sensor unit 10 and the swelling layer 60A disposed on the opposite side of the sensor unit 10 swell at the same time, the sensor unit 10 becomes stable. The time required for the sensor 30 A is half that of the sensor 30.

The sensor 30A has the effect of the sensor 30 and can perform stable measurement in a shorter time. The sensor 30A is easy to manufacture because the swelling layer 60A can be formed by dip coating.

<Modification of Second Embodiment>
Next, a sensor 30B according to a modification of the second embodiment will be described with reference to FIG. Since the sensor 30B of this modification is similar to the sensor 30, the same components are given the same reference numerals beginning with the same numerals, and the description thereof is omitted.

As shown in FIG. 12, the sensor 30B of the needle sensor unit 1B has a sensor unit 10B having a vertical structure. In the sensor unit 10B, a concave portion having a rectangular opening in plan view is formed in a substrate 11 made of a semiconductor such as silicon. The PD element 12B is formed on the wall surface (side surface) of the recess, and the LED element 15B is disposed on the bottom surface of the recess. That is, in the sensor unit having the vertical structure, the PD element 12B is formed in the vertical direction with respect to the main surface. And the filter layer 14B which interrupts | emits excitation light and permeate | transmits fluorescence is arrange | positioned so that the light-receiving surface of PD element 12B formed in the side surface may be covered.

The opening surface of the recess is wider than the bottom surface, and the side surface is not perpendicular to the bottom surface but is inclined at a predetermined angle θ. In addition, the board | substrate 11 which has a recessed part may be produced by joining the frame-shaped sensor frame board | substrate used as a recessed part, and a plane board | substrate.

A dried indicator layer 17B is disposed on the transparent intermediate layer 16B covering the LED element 15B. And the light shielding layer 18B which interrupts external light is arrange | positioned so that the opening of a recessed part may be covered. The surface of the light shielding layer 18B is a measurement surface. And the swelling layer 60B is arrange | positioned by the dip coating, for example in the whole surface of the outer peripheral surface of the front-end | tip part including the measurement surface of the sensor part 10B of the board | substrate 11. FIG.

As described above, in the sensor 30B, the sensor unit 10B has a recess having a bottom surface parallel to the main surface, and the light receiving surfaces of the PD element 12B and the PD element 12B that convert fluorescence into an electric signal are formed on the inner wall of the recess. The substrate 11 on which the covering filter layer 14B is disposed, the LED element 15B that generates excitation light disposed inside the recess, and the excitation light disposed above the LED element 15B inside the recess. When the light is received, it has an indicator layer 17B that emits fluorescence with a light amount corresponding to the analyte concentration, and a light shielding layer 18B through which the analyte that prevents the entry of external light can pass.

When the sensor 30B is inserted into the body, the body fluid containing the analyte is absorbed by the swelling layer 60B and the indicator layer 17B. For this reason, the sensor 30B has the same effect as the sensor 30 shown in FIG. Further, the sensor 30B is easier to miniaturize than the sensor 30 and is more sensitive.

Next, a method for manufacturing the sensor 30B will be briefly described. In addition, although it may manufacture for every sensor 30B, it is preferable to manufacture many sensors collectively as a wafer process.

First, a mask layer having a plurality of rectangular mask patterns in plan view is manufactured on the first main surface of a silicon wafer to be a substrate 11 having an area where a plurality of needle sensors can be manufactured. Then, a plurality of recesses having a bottom surface parallel to the first main surface is formed by an etching method.

The etching method is preferably a wet etching method using a tetramethylammonium hydroxide aqueous solution or a potassium hydroxide aqueous solution, but a dry etching method such as reactive ion etching or chemical dry etching may also be used.

In the wet etching method, when the silicon (100) plane is used as the silicon wafer, the etching speed of the (111) plane is anisotropic etching compared to the (100) plane. ) Plane and the angle with the (100) plane (bottom plane) is 54.7 degrees.

Next, the PD element 12B is formed on the four side surfaces of each recess by a known semiconductor process. The concave portion whose side surface is inclined has a larger area in which the PD element 12 can be formed than the concave portion whose vertical side surface is vertical, and the PD element 12B can be easily formed on the side surface. If the inclination angle of the side surface is 30 to 70 degrees, the above effect is remarkable.

Next, the filter layer 14B is disposed on the side PD element 12B. Next, the LED elements 15B are disposed on the bottom surfaces of the plurality of recesses. Further, after forming the transparent intermediate layer 16B so as to cover the LED element 15B, a buffer solution that becomes the indicator layer 17B is filled in the recess. Further, a light shielding layer 18B is disposed so as to cover the opening of the recess. Then, the silicon wafer on which a plurality of sensors are formed is singulated. Furthermore, the swelling layer 60B is disposed on the tip portion 32B by the dip coating method, and the sensor portion 10B is completed through a hydrogel drying process.

In the sensor 30B, the substrate 11 may be a main constituent member of the tip portion 32B, the main body portion 33, and the connector portion 35. That is, not only the tip portion 32B having the sensor portion 10B but also the main body portion 33 and the connector portion 35 may be manufactured by processing a silicon wafer.

As described above, the sensor 30B is easy to manufacture because the sensor unit 10B is formed in the recess formed in the substrate 11.

The present invention is not limited to the above-described embodiment, and various changes and modifications can be made without departing from the scope of the present invention.

This application is filed on the basis of the priority claim of Japanese Patent Application No. 2011-215815 filed in Japan on September 30, 2011, and the above disclosed contents include the present specification, claims, It shall be cited in the drawing.

Claims

A main body, a connector provided on the base end side of the main body, and a tip provided with a sensor unit for measuring an analyte concentration provided on the front end of the main body. ,
A needle-type sensor, wherein a swelling layer that swells by absorbing a liquid component of a subject is disposed on at least a part of the outer peripheral surface of the tip including the measurement surface of the sensor unit.
The swelling layer swollen more than the outer dimension of the sheath tube, which is punctured into the subject in a state in which the distal end portion is accommodated and is removed before leaving the analyte concentration measurement. The needle type sensor according to claim 1, wherein an outer dimension of the tip portion including the needle sensor is large.
3. The needle sensor according to claim 2, wherein the swelling layer is disposed on the outer peripheral surface on the back side with respect to the measurement surface.
The needle type sensor according to claim 3, wherein the swelling layer allows the analyte to pass therethrough and is disposed on the entire surface of the tip including the measurement surface.
The needle sensor according to claim 4, wherein the swelling layer is made of hydrogel.
The needle sensor according to claim 5, wherein the sensor unit is made of a hydrogel that swells by absorbing water in the body, and has an indicator layer that generates fluorescence according to the analyte concentration.
The sensor unit is
There is a recess having a bottom surface parallel to the main surface, and a substrate on which a photoelectric conversion element for converting fluorescence into an electric signal is formed on the inner wall of the recess,
A filter layer that covers the light receiving surface of the photoelectric conversion element and blocks excitation light and transmits fluorescence;
A light emitting element that emits excitation light, disposed above the filter layer inside the recess;
The indicator layer disposed on the upper side of the light emitting element inside the recess and receiving the excitation light to generate a light amount of fluorescence corresponding to the analyte concentration;
The needle sensor according to claim 6, further comprising an outermost layer that blocks external light.
A main body part, a connector part provided on the base end side of the main body part, and a front end part having a sensor part for measuring an analyte concentration provided on the front end side of the main body part, and the sensor part A needle-type sensor in which a swelling layer that swells by absorbing the liquid component of the subject is disposed on at least a part of the outer peripheral surface of the tip including the measurement surface;
An outer dimension of the tip including the swollen swelling layer, which is punctured in the subject with the tip housed therein, and is removed while leaving the tip in the body before starting the measurement of the analyte concentration. A needle-type sensor unit comprising: a sheath tube having a smaller outer dimension than the outer diameter.
The needle-type sensor unit according to claim 8, wherein the swelling layer is disposed on the outer peripheral surface on the back side with respect to the measurement surface.
The needle-type sensor unit according to claim 9, wherein the swelling layer allows the analyte to pass therethrough and is disposed on the entire surface of the tip including the measurement surface.
The needle-type sensor unit according to claim 10, wherein the swelling layer is made of hydrogel.
The needle-type sensor unit according to claim 11, wherein the sensor unit includes an indicator layer that is made of a hydrogel that swells by absorbing water in the body and generates fluorescence according to the analyte concentration. .
The sensor unit is
There is a recess having a bottom surface parallel to the main surface, a photoelectric conversion element that converts fluorescence into an electric signal on the inner wall of the recess, and a filter that covers the light receiving surface of the photoelectric conversion element and blocks excitation light and transmits fluorescence A substrate on which a layer is disposed;
A light emitting element that generates excitation light, disposed inside the recess;
The indicator layer disposed on the upper side of the light emitting element inside the recess and receiving the excitation light generates fluorescence having a light amount corresponding to the analyte concentration;
The needle-type sensor unit according to claim 12, further comprising an outermost layer that blocks external light.