JP6871985B2 - Biosensor and its manufacturing method - Google Patents

Description

The present invention relates to a biosensor and a method for manufacturing the same.

Conventionally, a stick-on type biosensor that is stuck on the surface of a living body and used is known. For example, a biocompatible polymer substrate has been proposed in which a first layer made of a flexible polymer material, a second layer harder than the first layer, and a data acquisition module are provided in order in the thickness direction (for example, the following patent documents). See 1.).

Japanese Unexamined Patent Publication No. 2012-10978

The biosensor is required to have an excellent wearing feeling when attached to the living body.

For example, if each member of the biosensor is flexible, an excellent wearing feeling can be obtained, and if the area of each member is small, an excellent wearing feeling can be obtained.

The second layer of the biocompatible polymer substrate of Patent Document 1 has a large area and is relatively hard, so that there is a problem that the wearing feeling is impaired.

Further, although the data acquisition module of the biocompatible polymer substrate of Patent Document 1 has a smaller area than that of the second layer, it is hard and thicker because it contains a hard material, so that the wearing feeling is impaired. There is.

The present invention provides a biosensor capable of imparting an excellent wearing feeling in consideration of the compressive elastic modulus, thickness and flat area of the member.

The present inventors pay attention to the rigidity K obtained from the compressive elastic modulus E and the thickness T of the member arranged on the base material, and if the rigidity K and the flat area S of the member satisfy the desired relational expression, they are excellent. We have found that a feeling of wearing can be imparted to a living body, and have come to the present invention.

The present invention [1] is arranged on a base material having a rigidity K of 3.0 N · mm ² or less represented by the following formula (1) and a first main surface of the base material, and has a rigidity of a predetermined value or more. Includes a biosensor that has and includes a component that satisfies the following formula (2).

In the formula (1), E is a compressive elastic modulus at 23 ° C. in which the unit is MPa, and T is the thickness in which the unit is mm. In the formula (2), K is represented by the above formula (1), and R is a rigidity having a ^{unit of N · mm 2} and S is a flat area having a ^{unit of cm 2.}

In this biosensor, the rigidity K of the base material is sufficiently low, and the parts having a certain degree of rigidity satisfy the equation (2) and have the rigidity K corresponding to the flat area S, which is excellent for the living body. It is possible to give a feeling of wearing.

In the present invention [2], the component includes a mounting component mounted on the base material and a sealing component for sealing the mounting component, and the mounted component has a flat area of ^{10 [cm 2] or less.} It has S1 and ^{a rigidity K1 of 1.0 × 10-2} [N · mm ² ] or more, and the sealing component has ^{a flat area S2 of 15 [cm 2} ] or more and 3.0 [N · mm 2] or more. ² ] The biosensor according to (1), which has the following rigidity K2.

In this biosensor, the mounted component has a high rigidity K1 while the flat area S1 is small, so that the wearing feeling is not impaired, and the sealed component has a large flat area S but a rigidity K2. Since it is low, the wearing feeling is not impaired. Therefore, it is possible to impart an excellent wearing feeling to the living body.

The present invention [3] comprises a base material having a rigidity K represented by the following formula (1) of 3.0 N · mm ² or less, and a component having a rigidity of a predetermined value or more and satisfying the following formula (2). The present invention includes a method for manufacturing a biosensor, comprising a first step of preparing the parts and a second step of arranging the parts on the first main surface of the base material.

In the formula (1), E is a compressive elastic modulus at 23 ° C. in which the unit is MPa, and T is the thickness in which the unit is mm. In the formula (2), K is represented by the above formula (1), and R is a rigidity having a ^{unit of N · mm 2} and S is a flat area having a ^{unit of cm 2.}

In this method for manufacturing a biosensor, in the first step, a base material having a sufficiently low rigidity K and a part having a certain degree of rigidity and satisfying the formula (2) are prepared, and in the second step, the part is used as a base. By arranging it on the material, it is possible to manufacture a biosensor capable of imparting an excellent wearing feeling to the living body.

The method for manufacturing a biosensor of the present invention and the biosensor obtained thereby provide an excellent wearing feeling to a living body.

It is a top view which shows one Embodiment of the biological sensor of this invention. It is sectional drawing which shows the position embodiment of the biological sensor of this invention. It is a top view which shows the test example of the biological sensor. It is sectional drawing which shows the test example of the biological sensor. The relationship between the rigidity K and the score (average value) of the wearing feeling is shown. The relationship between the flat area S and the rigidity K is shown. It is a figure which shows the evaluation result of the physical property of each sample group.

<One Embodiment>
<Attachable biosensor>
The patch-type biosensor 1 which is an embodiment of the biosensor of the present invention will be described with reference to FIGS. 1A to 1B.

The stick-on biosensor 1 has a substantially rectangular sheet shape extending in the in-plane direction (in the XY plane). The thickness direction of the stick-on biosensor 1 is the Z direction.

The stick-on biosensor 1 includes a base material 2 and a component 3 in order in the thickness direction (+ Z direction).

<Base material>
The base material 2 is a support material that supports the stick-on biosensor 1 and is an adhesive material that imparts pressure-sensitive adhesiveness (adhesiveness) to the stick-on biosensor 1 (pressure-sensitive adhesive support base material). ).

The substrate 2 preferably has the widest flat area S, the lowest compressive modulus E, and the thinnest thickness T in the patchable biosensor 1. The rigidity K of the base material 2 will be described later, but is preferably the lowest in the stick-on biosensor 1.

The base material 2 has a first main surface 21 on the front surface side in the thickness direction of the stickable biosensor 1 and a second main surface 22 on the back surface side. The plan-view shape of the base material 2 is substantially the same as the plan-view shape of the stick-on biosensor 1. Specifically, the base material 2 has a substantially rectangular sheet shape extending in the longitudinal direction (X direction in the examples of FIGS. 1A and 1B) of the stickable biosensor 1.

The base material 2 includes, for example, a pressure-sensitive adhesive layer 6 and a support layer 7 in order in the thickness direction (Z direction). The pressure-sensitive adhesive layer 6 forms the second main surface 22 of the base material 2, and forms the sticking surface of the base material 2. The support layer 7 forms the first main surface 21 of the base material 2, and forms the support surface that supports the component 3 on the base material 2.

Each of the pressure-sensitive adhesive layer 6 and the support layer 7 has the same plan-view shape as the base material 2.

Examples of the material of the pressure-sensitive adhesive layer 6 include a pressure-sensitive adhesive having biocompatibility, and specifically, it is selected to have a rigidity K described later. Examples of such a pressure-sensitive adhesive include an acrylic pressure-sensitive adhesive, a silicone-based pressure-sensitive adhesive, and preferably an acrylic pressure-sensitive adhesive.

Examples of the material of the support layer 7 include an insulator having elasticity, and specifically, the material is selected to have a rigidity K described later. Examples of such an insulator include polyurethane-based resin, silicone-based resin, acrylic-based resin, polystyrene-based resin, vinyl chloride-based resin, polyester-based resin, and the like, and polyurethane-based resin is preferable.

Stiffness K of the base material 2, but is 3.0 N · mm ² or ^less, or may be ¹⁰ -2 N · mm ² or less. Preferably, it is 10 ^-3 N · mm ² or less, more preferably 10 ^-4 N · mm ² or less, further preferably 10 ^-5 N · mm ² or less, and particularly preferably 5 × 10 ^-6 N · mm. ^{It is 2} or less.

The rigidity K of the base material 2 is represented by the formula (1).
^{K = ET 3/12 (1} )
Here, E is a compressive elastic modulus at 23 ° C. in which the unit is MPa, and T is a thickness in which the unit is mm.

If the rigidity K of the base material 2 exceeds the above-mentioned upper limit, the wearing feeling of the stick-on biosensor 1 on the living body is impaired.

On the other hand, the rigidity K of the base material 2 is, for example, ^10-10 N · mm ² or more, preferably ^10-9 N · mm ² or more. When the rigidity K of the base material 2 is equal to or higher than the above-mentioned lower limit, the mechanical strength of the stickable biosensor 1 is excellent and the handleability is good.

As described in the above formula (1), the rigidity K is determined by the compressive elastic modulus E and the thickness T. Therefore, the compressive elastic modulus E and the thickness T of the base material 2 are within the above range of the rigidity K. Is selected to be.

Specifically, the compressive elastic modulus E at 23 ° C. of the base material 2 is, for example, a value when the pressure-sensitive adhesive layer 6 and the support layer 7 are measured together, and is, for example, 7,000 MPa or less, preferably 3000 MPa. It is less than or equal to, and is, for example, 0.1 MPa or more.

The thickness T of the base material 2 is the total thickness of the pressure-sensitive adhesive layer 6 and the support layer 7, and is, for example, 0.1 mm or less, preferably 0.01 mm or less, and for example, 0.1 μm or more. It is preferably 1 μm or more.

The ratio of the thickness of the pressure-sensitive adhesive layer 6 to the thickness of the support layer 7 (thickness of the pressure-sensitive adhesive layer 6 / thickness of the support layer 7) is, for example, 0.5 or more, preferably larger than 1. It is preferably 3 or more, and is, for example, 20 or less, preferably 10 or less. Specifically, the thickness of the pressure-sensitive adhesive layer 6 is, for example, 10 μm or more, preferably 20 μm or more, and for example, 95 μm or less, preferably 70 μm or less, more preferably 50 μm or less. The thickness of the support layer 7 is 1 μm or more, preferably 5 μm or more, and is, for example, 95 μm or less, preferably 50 μm or less, more preferably 10 μm or less.

The flat area S of the base material 2 is appropriately selected in consideration of the size and number of the parts 3 arranged on the base material 2, the handleability of the stick-on biosensor 1 when the base material 2 is attached to the living body, and the like. Specifically, the flat area S of the base material 2 is, for example, 1 cm ² or more, preferably 10 cm ² or more, and for example, 1000 cm ² or less, preferably 250 cm ² or less.

<Parts>
The component 3 is arranged on the first main surface 21 of the base material 2. The component 3 is included in the XY plane of the base material 2 in a plan view. Within the scope of this specification and claims, the term "part" refers to a component mounted on the base material 2 having a rigidity equal to or higher than a predetermined value, and more specifically, a component having a rigidity equal to or higher than the rigidity of the base material. This is because a component having a hardness higher than that of the base material may cause deterioration of the wearing feeling due to the component.

In the component 3, the compressive elastic modulus E and the thickness T are set so as to have the rigidity K described later, but preferably, the component 3 has a compressive modulus E higher than that of the base material 2 and / or the base material. It is permissible to have a thickness T thicker than 2 and a stiffness K higher than the substrate 2.

A plurality of parts 3 are arranged on the base material 2. Specifically, the component 3 includes, for example, a mounting component 4 mounted on the base material 2 and a sealing component 5 for sealing the mounting component 4.

A plurality of mounting components 4 are arranged adjacent (opposing) to each other on the first main surface 21 of the base material 2 at intervals in the longitudinal direction.

Each of the plurality of mounting components 4 has a relatively small flat area S1 among the plurality of components 3. The flat area S1 of the mounting component 4 is, for example, 12.5 cm ² or less, preferably 10 cm ² or less, more preferably 7.5 cm ² or less, still more preferably 5 cm ² or less, and for example, 0. 01cm ² or more, preferably, 0.1 cm ² or more. The thickness T, compressive modulus E, and rigidity K of the mounting component 4 will be described in detail later.

Specific examples of the mounting component 4 include an electronic board (control circuit board, etc.) in which electronic devices such as a battery, a microcomputer, and a memory are mounted on a board (hard board), and a package in which the electronic board is housed in a housing. Examples include a board package configured as. A plurality of mounting components 4 are appropriately selected from the above-mentioned specific examples. The shape of the mounting component 4 is not particularly limited, and for example, a slightly thick-walled substantially circular shape in a plan view (specifically, a substantially cylindrical shape), for example, a slightly thin-walled substantially rectangular shape in a plan view (specifically, a substantially cylindrical shape). Specifically, a substantially rectangular flat plate shape) and the like can be mentioned.

The mounting component 4 further includes a plurality of electrodes 8 that act as sensors (detection units), and each of the plurality of electrodes 8 is based on such that the electrode surface is exposed on the second main surface 22 of the base material 2. It is buried in the material 2. Each of the plurality of electrodes 8 has, for example, a substantially net (well girder) shape composed of conducting wires (crossing conducting wires) intersecting with each other in bottom view. In the stick-on biosensor 1, the electrode 8 senses (detects) a weak signal in the living body as an electric signal, inputs the weak signal to the control circuit board, and processes the electric signal based on the electric power supplied from the battery. And memorize it as information.

Examples of the material of the mounting component 4 include hard materials such as ceramics, hard resin (specifically, ABS resin, acrylic resin, polyethylene terephthalate resin, etc.), and metal (conductor such as copper).

As an example, the sealing component 5 is a sealing that collectively covers and seals a plurality of mounting components 4 (specifically, mounting components 4 other than the electrode 8) on the first main surface 21 of the base material 2. It is a stop layer. The sealing layer has a sheet shape extending in the XY plane, covers the upper surface and the peripheral side surface in the thickness direction of the mounting component 4, and seals the mounting component 4.

The sealing component 5 has a relatively large flat area S2 among the plurality of components 3. The flat area S2 of the sealing component 5 is larger than the flat area S1 of the mounting component 4, for example, ^{exceeding 12.5 cm 2} , preferably 15 cm ² or more, more preferably 20 cm ² or more, and for example. It is 100 cm ² or less. The thickness T, compressive modulus E, and rigidity K of the sealing component 5 will be described in detail later. The thickness T of the sealing component 5 is the distance between one surface of the base material 2 in the thickness direction and one surface of the sealing component 5 in the thickness direction.

Examples of the material of the sealing component 5 include a soft material, specifically, an insulator (including gel) having elasticity, and more specifically, a hard material of the mounting component 4. Examples include soft materials. Specifically, it is appropriately selected from the soft materials exemplified in the base material 2 so as to have the above-mentioned physical properties.

<Rigidity and flat area of parts>
In this stick-on biosensor 1, the component 3 satisfies the following equation (2).
K ≦ 6.34 × 10 ¹⁴ × S ^-10.6 (2)
Here, K is a rigidity represented by the above formula (1) and having a unit of N · mm ^2. S is a flat area having a unit of cm ^2.

Specifically, when a plurality of parts 3 are arranged on the base material 2, all of the plurality of parts 3 satisfy the formula (2).

More specifically, it is desirable that both the mounting component 4 and the sealing component 5 satisfy the equation (2). In other words, the sticking type biosensor 1 which does not satisfy the formula (2) even at one of the mounting component 4 and the sealing component 5 is not included in the present invention.

When the component 3 does not satisfy the equation (2), that is,
K> 6.34 × 10 ¹⁴ × S ^-10.6
In the case of, the wearing feeling is impaired.

The wearing feeling includes, for example, pain, itching, tension, rash, discomfort caused by stuffiness, and discomfort caused by peeling, which the living body feels.

The formula (2) is synonymous with the following formula (4).
Log10 (K / 6.34) ≦ 14 × S ^-10.6 (4)
The region of the flat area S and the stiffness K that satisfies the equations (2) (and the equation (4)) includes the uppermost curve C1 in FIG. 4 and the hatched range below the curve C1. Area.

Preferably, in this stick-on biosensor 1, both the mounting component 4 and the sealing component 5 satisfy the formula (3).
^{K ≦ 2.97 × 10 8 × S} -7.39 (3)
If the formula (3) is satisfied, a more excellent wearing feeling can be imparted to the living body.
The formula (3) is synonymous with the following formula (5).
Log10 (K / 2.97) ^≤8 × S-7.39 (5)
The region of the flat area S and the rigidity K satisfying the equations (3) (and the equation (5)) includes the range on the curve C2 located at the center and the range below the curve C2 among the three curves in FIG. The area.

On the other hand, it is also preferable to satisfy the following formula (6).
K ≧ 325 × S- ⁵ (6)
The region of the flat area S and the rigidity K that satisfies the formula (6) is a region including the uppermost curve C3 in FIG. 4 and the range above the curve C3.

If the formula (6) is satisfied, each component 3 has sufficient rigidity. However, even in this case, both the equation (1) and the equation (6) are satisfied. Therefore, the stick-on biosensor 1 can impart an excellent wearing feeling to the living body while ensuring the rigidity of each component 3.

Specifically, the thickness T of the component 3 is, for example, 0.01 mm or more, and for example, 10 mm or less.

The compressive elastic modulus E of the component 3 at 23 ° C. is, for example, 100 MPa or more, and for example, 100,000 MPa or more.

The flat area S of the component 3 is, for example, 0.1 cm ² or more, and is, for example, 500 cm ² or less.

Especially, the parts 3, small plane area S1 (preferably, 10 cm ² or less) mounting component 4 having, and, (preferably, 15cm ² or more) planar area S2 greater than the mounting part 4 of sealing part 5 having a When provided, the thickness T1 of the mounting component 4 is preferably more than 2 mm, the compressive modulus E at 23 ° C. is preferably 10,000 MPa or more, and the thickness T1 and the compressive modulus E It is permissible that the rigidity K1 calculated from the equation (2) is as high as 1.0 × 10 ^-2 [N ・ mm ² ] or more, and further 1.0 × 10 ^-1 [N ・ mm ^{2] or more.} To.

The thickness T2 of the sealing component 5 is preferably 2 mm or less, the compressive elastic modulus E at 23 ° C. is preferably 5,000 MPa or less, and the formula (2) is based on the thickness T2 and the compressive elastic modulus E. The rigidity K2 calculated from is 3.0 [N ・ mm ² ] or less, or 1.0 × 10 ^-3 [N ・ mm ² ] or less, and further 1.0 × 10 ^-4 [N ・ mm ^2]. ] It is suppressed as below (set low).

<Method of deriving formulas for rigidity and flat area>
The derivation method of each of the above equations will be described in detail. Specific samples, numerical values, etc. will be described in detail later in the Examples column.

First, the base material 2 and the plurality of parts 3 are prepared.

Next, as shown in FIGS. 2A to 2B, each of the plurality of parts 3 is arranged on the first main surface 21 of the base material 2, and a plurality of samples of the stickable biosensor 1 are manufactured. The base material 2 is commonly used for a plurality of parts 3, and specifically, one type of base material 2 is used.

Here, as shown in FIG. 5, a plurality of samples having the same flat area S but different thickness T and / or compressive elastic modulus E are classified as one sample group.

In one sample group, the rigidity K of the parts 3 of the plurality of samples is different because the thickness T and / or the compressive elastic modulus E are different.

Prepare a plurality of such sample groups. That is, a plurality of sample groups having different flat areas S of the parts 3 are prepared.

The sample is then applied to the skin of the human body. Specifically, the second main surface 22 of the base material 2 (pressure sensitive adhesive layer 6) is attached to the skin.

For each sample, the pain, itchiness, tension, rash, discomfort caused by stuffiness, and discomfort caused by peeling (that is, wearing feeling) that the human body feels are scored. Specifically, each of the above-mentioned plurality of items relating to the feeling of wearing is evaluated on a scale of 1 to 4 points or 1 to 3 points, and points are given. One sample is tested on a plurality of subjects (n = plural), and the average value of the scores given to the plurality of subjects is obtained.

The average value of the points is classified for each sample group (that is, for each flat area S in which the parts 3 are the same), and subsequently, as shown in FIG. 3, the rigidity K is obtained for each of the plurality of samples in one sample group. And plot the score.

Specifically, for a plurality of samples in which the parts 3 have the same flat area S, the horizontal axis is the rigidity K, and the vertical axis is plotted on the graph showing the score of the wearing feeling. After that, approximate lines L (L1 to L4, etc.) that approximate the plotted points are drawn. After that, the intersection of the drawn approximate line L and the reference point of the wearing feeling is obtained, and the reference rigidity K'(first reference rigidity K _1st and further, the second reference rigidity K _2nd ) at such an intersection is acquired. The reference point of the wearing feeling is that if it is below that point, an excellent wearing feeling can be given to the living body, but if it exceeds that point, the wearing feeling is impaired. As shown in FIG. 5, one sample group acquires one reference stiffness K'(specifically, each of the first reference stiffness K _1st and the second reference stiffness K _2nd , which will be described later). Specific examples of the reference point and the reference rigidity K'will be described later in Examples.

The process of obtaining one reference stiffness K'for one sample group described above is also carried out for the other sample groups. As a result, each of the plurality of sample groups acquires each of the plurality of reference stiffnesses K'.

As shown in FIG. 4, subsequently, the reference rigidity K'of the plurality of sample groups and the flat area S corresponding to each of the plurality of sample groups are shown by the flat area S on the horizontal axis and the rigidity K on the vertical axis. Plot on the graph.

Then, approximate curves C (C1 and C2) that approximate the plotted points are drawn, and then equations (2) and (3) expressed as calculation equations for the approximate curve C are obtained.

<Manufacturing method of biosensor>
Next, a method of manufacturing the stick-on biosensor 1 will be described.

The method for manufacturing the stick-on biosensor 1 includes a first step and a second step. In this manufacturing method, the first step and the second step are carried out in order.

In the first step, a base material 2 having a rigidity K of 3.0 N · mm ² or less and a component 3 having a predetermined rigidity and satisfying the formula (2) are prepared.

In this first step, first, only the base material 2 having the flat area S and the rigidity K satisfying the formula (2) is selected and prepared.

Next, when the component 3 includes the mounting component 4 and the sealing component 5, the materials of the mounting component 4 and the sealing component 5 are used, and each of the mounting component 4 and the sealing component 5 has a predetermined compressive elastic modulus E. Further, the thickness T of each of the mounting component 4 and the sealing component 5 is determined. By substituting the compressive elastic modulus E and the thickness T into the equation (1), the rigidity K is obtained. Subsequently, the flat area S corresponding to each component 3 is determined so as to satisfy the equation (2).

In the second step, the component 3 is arranged on the first main surface 21 of the base material 2.

Specifically, first, the mounting component 4 is placed on the first main surface 21 of the base material 2, and then the sealing component 5 covers the first main surface 21 of the base material 2 and the peripheral side surface. Place in. As a result, the sealing component 5 covers (seals) the mounting component 4. The electrode 8 is arranged on the second main surface 22 of the base material 2, or an opening is formed so as to penetrate the thickness direction of the base material 2, and the electrode 8 is arranged on the second main surface 22. Later, the opening can be filled with the material of the base material 2.

As a result, the stick-on biosensor 1 is obtained.

In this stick-on biosensor 1, the rigidity K of the base material 2 is sufficiently low, and the component 3 satisfies the equation (2) and has the rigidity K corresponding to the flat area S. It is possible to give an excellent wearing feeling.

In this stick-on biosensor 1, the mounting component 4 has a high rigidity K1 while the flat area S1 is small, so that the wearing feeling is not impaired, and the sealing component 5 is compared with the mounting component 4. While the flat area S is large, the rigidity K2 is low, so that the wearing feeling is not impaired. Therefore, it is possible to impart an excellent wearing feeling to the living body.

In this method of manufacturing the stick-on biosensor 1, in the first step, a base material 2 having a sufficiently low rigidity K and a component 3 satisfying the formula (2) are prepared, and in the second step, the component 3 is used as a base material. By arranging it in 2, it is possible to manufacture a stick-on biosensor 1 that can give an excellent wearing feeling to the living body.

<Modification example>
In each of the following modifications, the same members and processes as those in the above-described embodiment are designated by the same reference numerals, and detailed description thereof will be omitted. In addition, each modification can be combined as appropriate. Further, each modification can exert the same effect as that of one embodiment, except for special mention.

Living organisms include the human body and non-human organisms. As a living body, it is preferably a human body.

In one embodiment, when the component 3 is prepared in the first step, the physical properties of the component 3 are determined in the order of compressive elastic modulus E, thickness T, and flat area S, but the component 3 satisfies the formula (2). For example, the order is not limited. For example, first, the flat area S is determined, then the compressive elastic modulus E and the thickness T are determined in order so as to satisfy the equation (2), or the thickness T and the compressive elastic modulus E are determined in order, and further, The thickness T and the compressive elastic modulus E can be determined at the same time.

Examples and comparative examples are shown below, and the present invention will be described in more detail. The present invention is not limited to Examples and Comparative Examples. In addition, specific numerical values such as the compounding ratio (content ratio), physical property values, and parameters used in the following description are described in the above-mentioned "Form for carrying out the invention", and the compounding ratios corresponding to them ( Substitute for the upper limit (numerical value defined as "less than or equal to" or "less than") or lower limit (numerical value defined as "greater than or equal to" or "exceeded") such as content ratio), physical property value, parameter, etc. it can.

Test Example 1
<Example of deriving equation (2)>
A base material 2 and a plurality of parts 3 were prepared.

The base material 2 is made of skin-friendly permilol (registered trademark) Lite (polyurethane resin, manufactured by Nitoms Co., Ltd.), has a thickness T of 0.008 mm, a flat area S of 50 cm ² , and a compressive elastic modulus E of 25 MPa.

The materials and physical properties of the plurality of parts 3 are shown in FIG. Details of the test materials 1 to 3 in FIG. 5 are shown below.
Test material 1: ABS resin Test material 2: Elastic gel, polyurethane resin, hardness 0, model number H0-100 (manufactured by EXCEL)
Test material 3: Elastic gel, polyurethane resin, hardness 7, model number H5-100 (manufactured by EXCEL)
The numerical values after “E +” or “E−” in the rigidity K column of FIG. 5 represent an exponent of 10, and for example, “8.3E + 01” means “8.3 × 10 ¹ ”. Also in FIGS. 3 to 4, “E +” or “E−” has the same meaning as described above.

As shown in FIGS. 2A to 2B, each of the plurality of parts 3 was then arranged on the first main surface 21 of the base material 2 to produce a plurality of samples.

As shown in FIG. 5, a plurality of samples including the parts 3 having the same flat area S were classified as one sample group. Specifically, in Test Example 1, three samples having the components 3 having a plane area S of 2 cm ² was classified into the first sample group, four samples comprising a component 3 having a plane area S of 5 cm ² Classify into the second sample group, 5 samples having the part 3 having the flat area S of ^{12 cm 2} are classified into the 3rd sample group, and 3 samples having the part 3 having the flat area S of ^{20 cm 2 are classified into the 4th sample group.} It was classified into a sample group.

Further, one type of sample was produced in the same number (specifically, three) as the number of subjects.

Subsequently, each of a plurality (three) samples of the same type was attached to the skin of each of three human bodies (subjects) (n = 3). Then, each of the following items (fitting feeling) was evaluated for each subject, and a score for wearing feeling was obtained for each subject. Since the indicators of "itch / pain" and "rash" particularly affect the wearing feeling, they were multiplied by a coefficient of 5 times and the scores of each indicator were added to obtain the total. FIG. 5 shows the average value of the wearing feeling points of the three subjects.

(Itching / pain)
4 points Painful 3 points Itchy 2 points Tingling 1 point I didn't mind (tight)
3 points Tightened 2 points at rest and exercise, but not taut at rest, 1 point taut at rest I didn't mind either at rest or during exercise (rash)
4 points 3 points with a rash 2 points with traces 1 point with redness No abnormality (stuffiness)
3 points I felt uncomfortable and couldn't stand 2 points I felt uncomfortable, but I could endure 1 point I didn't mind (peeling)
3 points Completely peeled 2 points Partially peeled 1 point Not peeled In the above evaluations (5 evaluations), a total of 13 points (itch / pain: 1 point x 5 (coefficient), tension: 1 point, rash 1 point x 5 (coefficient), stuffiness: 1 point, peeling: 1 point total) is the lowest point, indicating that the best wearing feeling is given. A total of 49 points (itch / pain: 4 points x 5 (coefficient), tension: 3 points, rash: 4 points x 5 (coefficient), stuffiness: 3 points, peeling: 3 points total points) is the highest point. Yes, it indicates that the wearing feeling is most impaired.

As a result of the evaluation, the average value of the wearing feeling points is shown in FIG. Then, as shown in FIG. 3, each of the plurality of samples in the first sample group to the fourth sample group was plotted on a graph in which the horizontal axis represents the rigidity K and the vertical axis represents the average value of the wearing feeling.

After that, an approximate line L (a thick solid line sloping diagonally upward on the right side) was drawn to approximate a plurality of points plotted for each sample group. Specifically, four approximate lines (thick lines) L1 to L4 were drawn corresponding to the first sample group to the fourth sample group.

Then, four approximation lines L1 to L4, respectively determined the intersection point of the first reference point of the installation feeling, and acquires the first reference stiffness K _1st in such intersections.

In this Test Example 1, the first reference point was set to 23 points. For 23 points, about 28% of the points (36 points) obtained by subtracting the lowest points (13 points) from the highest points (49 points) in the evaluation of wearing comfort (10 points) are added to the lowest points (13 points). Value (13 points + 10 points). If it is below the first reference point, it indicates that the sample imparts an excellent wearing feeling to the living body.

One sample group has one first reference stiffness K _1st . Specifically, as shown in FIG. 5, the first sample group has the first reference rigidity K _1st : 1.8 × 10 ¹⁹ N ・ mm ² , and the second sample group has the first reference rigidity K. _1st : 1.2 × 10 ⁷ N ・ mm ² , the third sample group has the first reference stiffness K _1st : 1.5 × 10 ³ N ・ mm ² , and the fourth sample group is the first. 1 Reference rigidity K _1st : 2.1N ・ mm ² .

Then, as shown in FIG. 4, the first reference stiffness K _1st and the flat area S of the first sample group to the fourth sample group are plotted on a graph shown by the flat area S on the horizontal axis and the stiffness K on the vertical axis. .. In this Test Example 1, four points were plotted on the graph.

After that, an approximate curve C1 that approximates the four plotted points was drawn, and an equation (2) represented as a calculation formula for the approximate curve C1 was obtained.
K ≦ 6.34 × 10 ¹⁴ × S ^-10.6 (2)
Test Example 2
<Example of deriving equation (3)>
The treatment was carried out in the same manner as in Test Example 1 except that the second reference rigidity K _2nd was acquired instead of the acquisition of the first reference rigidity K _{1st shown in FIG.}

In this test example, the second reference point, which has stricter wearing comfort requirements than the first reference point, was adopted. The second reference point was set to 18 points. For 18 points, about 14% of the points (36 points) obtained by subtracting the lowest points (13 points) from the highest points (49 points) in the evaluation of wearing comfort (5 points) are added to the lowest points (13 points). Value (13 points + 5 points). If it is below the second reference point, it indicates that the sample imparts an even better wearing feeling to the living body.

Further, one sample group has one second reference stiffness K _2nd , and its specific value is as shown in FIG.

Further, as shown in FIG. 4, the formula (3) represented as the calculation formula of the approximate curve C2 was obtained.

Example 1
As shown in FIG. 1, a stick-on biosensor 1 including a base material 2 and a plurality of parts 3 arranged on one surface in the thickness direction of the base material 2 was prepared.

The component 3 is a mounting component 4 composed of a battery and a substrate package, and a sealing component 5 composed of a sealing layer.

The base material 2 is made of skin-friendly permilol (registered trademark) Lite (manufactured by Nitoms), and has a thickness T of 0.1 mm, a flat area S of 30 cm ² , and a compressive elastic modulus E of 25 MPa. By substituting the values of the compressive elastic modulus E and the thickness T into the equation (1), the rigidity K1.1 × ^10-6 of the base material 2 was obtained. The rigidity K1.1 × ^10-6 of the base material 2 was within the range of 3.0 N · mm ^{2 or less.}

It is assumed that the battery (mounting component 4) is hard, has a thickness T of 2 mm, a flat area S of 3.1 cm ² , and a compressive elastic modulus E of 200,000 MPa of the hardest stainless steel as a battery constituent material. The compression modulus E and the thickness T are substituted into equation (1), to obtain a rigidity ^{K1.3 × 10 5 N · mm 2} . Then, the rigidity K and the flat area S of the battery (mounting component 4) were substituted into the equation (2) to satisfy the inequality of the equation (2).

The substrate package (mounting component 4) is rigid, has a thickness T of 0.3 mm, a flat area S of 7.5 cm ² , and a compressive elastic modulus E of 3,000 MPa. The compressive elastic modulus E and the thickness T were substituted into the equation (1) to obtain a ^{rigidity K6.8 N · mm 2.} Then, the rigidity K and the flat area S of the board package (mounting component 4) were substituted into the equation (2) to satisfy the inequality of the equation (2).

The thickness T of the sealing layer (sealing component 5) is made of a soft polyurethane resin, the thickness of which is 3 mm, the flat area S is 16.5 cm ² , and the compressive elastic modulus E is 0.04 MPa. The compressive elastic modulus E and the thickness T were substituted into the equation (1) to obtain a ^{rigidity K0.00009N · mm 2.} Then, the rigidity K and the flat area S of the sealing layer (sealing component 5) were substituted into the equation (2) to satisfy the inequality of the equation (2).

That is, the base material 2 satisfied the formula (1), and both the mounting component 4 and the sealing component 5 satisfied the formula (2).

Even if the stick-on biosensor 1 was stuck on the skin of a human body, the wearing feeling was excellent.

Comparative Example 1
A stick-on biosensor 1 was obtained by processing in the same manner as in Example 1 except that the battery (mounting component 4) did not satisfy the formula (1), and the stickable biosensor 1 was stuck on the skin of the human body. Good fit was impaired.

Specifically, the thickness T of the battery (mounting component 4) is 2 mm, the flat area S is 12 cm ² , and the left side> the right side is obtained by substituting into the equations (1) and (2), and the equation (2). ) Did not satisfy the inequality.

Comparative Example 2
Except that the substrate package (mounting component 4) did not satisfy the formula (1), the same treatment as in Example 1 was carried out to obtain a stickable biosensor 1, which was stuck to the skin of a human body. Good fit was impaired.

Specifically, the flat area of the board package (mounting component 4) is 30 cm ² (excessive), and by substituting into equations (1) and (2), the left side> the right side, and the inequality of equation (2). I was not satisfied.

Comparative Example 3
A sticking type biosensor 1 was obtained by treating in the same manner as in Example 1 except that the sealing layer (sealing component 5) did not satisfy the formula (1), and this was stuck to the skin of the human body. Good fit was impaired.

Specifically, the compressive elastic modulus E of the sealing layer (sealing component 5) is 1,000 MPa (excessive), and a rigidity K2250N · mm ² is obtained, which is substituted into the equation (2). , Left side> right side, and did not satisfy the inequality in equation (2).

Comparative Example 4
A stick-on biosensor 1 was obtained by processing in the same manner as in Example 1 except that the battery (mounting component 4) did not satisfy the formula (1), and the stickable biosensor 1 was stuck on the skin of the human body. Good fit was impaired.

Specifically, the thickness T of the battery (mounting component 4) was 80 mm (extremely thick), and the rigidity K8.5 × 10 ⁹ N · mm ² was obtained by substituting into the equation (1). Substituting this into equation (2), left side> right side, and the inequality in equation (2) was not satisfied.

1 Stick-on biosensor 2 Base material 3 Parts 4 Mounting parts 5 Encapsulation parts 21 First main surface 22 Second main surface

Claims (4)

It is a stick-on type biosensor that is pressure-sensitively adhered to the skin surface.
A base material having a rigidity K of 3.0 N · mm ² or less represented by the following formula (1),
It is provided with a component that is arranged on the first main surface of the base material, has rigidity equal to or higher than a predetermined value, and satisfies the following formula (2) .

Here, E in the formula (1) is represented by a compressive elastic modulus at 23 ° C. in which the unit is MPa, T is represented by the thickness formula (2) in which the unit is mm, and K in the formula (1) is represented by the above formula (1). rigid but is N · mm ^2, S is Ri plane area der units are cm ^2, and
The surface of the component is exposed on a mounting component mounted on the first main surface of the base material and sealed with a sealing component, and a second main surface opposite to the first main surface. Both the mounting component and the sealing component, including the electrode, have the following formula (3).
^{K ≦ 2.97 × 10 8 × S} -7.39 (3)
A biosensor characterized by satisfying . The biosensor according to claim 1, wherein the rigidity of the component is equal to or higher than the rigidity of the base material. Before Symbol mounted component has a 10 [cm ^2] or less of the planar area ^{S1, 1.0 × 10 -2 [N} · mm 2] or more and rigidity K1,
The biosensor according to claim 1 or 2, wherein the sealing component has a flat area S2 of ^{15 [cm 2 ] or more and a rigidity K2 of 3.0 [N · mm 2] or less.} .. A method for manufacturing a stick-on biosensor that is pressure-sensitively adhered to the skin surface.
The first step of preparing a base material having a rigidity K of 3.0 N · mm ² or less represented by the following formula (1) and a component having a rigidity of a predetermined value or more and satisfying the following formula (2).
The first major surface of the substrate, e Bei a second step of placing the component,

Here, E in the formula (1) is represented by a compressive elastic modulus at 23 ° C. in which the unit is MPa, T is a thickness in which the unit is mm, and K in the formula (2) is represented by the above formula (1). rigid units is N · mm ^2, S is Ri plane area der units are cm ^2, and
The surface of the component is exposed on a mounting component mounted on the first main surface of the base material and sealed with a sealing component, and a second main surface opposite to the first main surface. Both the mounting component and the sealing component, including the electrode, have the following formula (3).
^{K1 ≦ 2.97 × 10 8 × S1} -7.39 (3)
A method for manufacturing a biosensor, which is characterized by satisfying .

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