JP6214858B2 - Electrode unit and method for manufacturing electrode unit - Google Patents

Description

  The present invention relates to an electrode unit that is mounted on a living body and used to acquire a biological signal. Moreover, this invention relates to the shaping | molding die used in order to cover the electrode element with which the said electrode unit is equipped, and shape | mold the gel member which has adhesiveness and electroconductivity. Furthermore, this invention relates to the manufacturing method of the said electrode unit.

  As this type of electrode unit, one having an arrangement in which an electrode element is arranged on a base material and the electrode element is covered with an adhesive and conductive gel member is known (for example, see Patent Document 1). . When the gel member is brought into contact with the living body to be measured, the electrode unit is held on the living body by the adhesiveness, and a biological signal can be acquired through the electrode element.

JP 2008-12164 A

  An electrode unit used in a neonatal intensive care unit (NICU) or the like is required to be miniaturized in order to be attached to a premature baby or a newborn baby. Since it is necessary to ensure a certain size of the electrode element used for taking out the biological signal, the size of the gel member becomes relatively small, and a step is likely to occur in a portion covering the electrode element. As a result, the adhesiveness is lowered, so that a part of the gel member may be peeled off from the living body during measurement, or the electrode unit itself may be dropped from the living body, and thus there is a possibility that the biosignal may not be acquired normally.

  Therefore, an object of the present invention is to provide a technique for improving the adhesion of an electrode unit to a living body while meeting the demand for miniaturization.

In order to achieve the above object, a first aspect that the present invention can take is an electrode unit attached to a living body,
A substrate;
An electrode element disposed on the substrate;
A signal extraction member electrically connected to the electrode element;
A gel member attached to the base material so as to cover the electrode element and having adhesiveness and conductivity,
At least a part of the portion of the gel member covering the electrode element is thinner than the peripheral edge.

  According to such a configuration, since the thin portion faces the electrode element, a step due to the thickness of the electrode element is unlikely to occur on the contact surface with the living body. By making the said contact surface flat, the adhesiveness with the biological body of an electrode unit can be improved. Moreover, since sufficient quantity of gel can be arrange | positioned to the peripheral part made thick relatively, the drying of the said location can be suppressed. This also improves the adhesion with the living body.

In order to achieve the above object, a second aspect that the present invention can take is an electrode unit attached to a living body,
A substrate;
An electrode element disposed on the substrate;
A signal extraction member electrically connected to the electrode element;
A gel member attached to the base material so as to cover the electrode element and having adhesiveness and conductivity,
On the surface of the gel member that comes into contact with the living body, at least one recess is formed in a region excluding the peripheral edge.

  According to such a configuration, by pressing the gel member against the living body, the concave portion is crushed and air is released, so that a suction cup action can be generated on the contact surface. Therefore, the adhesion between the electrode unit and the living body is improved. On the other hand, when removing the electrode unit from the living body, only the peripheral portion of the gel member is peeled off from the skin, so that the sucker action is lost, and the entire gel member can be easily separated from the living body. Since premature babies and newborns in a neonatal intensive care unit (NICU) have thin and soft skin, it is necessary to minimize the burden on the skin when attaching and detaching the electrode unit. According to this configuration, while being excellent in adhesion to the skin, the gel member can be easily peeled and separated from the skin, so that the requirement can be sufficiently met.

  In any of the first aspect and the second aspect, at least a part of the electrode element is disposed on the first side of the base material, and the signal extraction member includes the first side of the base material and May be arranged on the opposite second side. In this case, the thickness of the electrode element disposed on the first side of the substrate on which the gel member is mounted can be minimized. As a result, a step due to the electrode element is unlikely to occur on the contact surface of the gel member, which contributes to improving the adhesion to the living body.

  As described above, according to the electrode unit of the present invention, even when the size of the gel member with respect to the electrode element is relatively small, it is possible to suppress a decrease in adhesion and to obtain a stable biological signal. It becomes possible. That is, both the miniaturization of the electrode unit and the measurement stability can be achieved.

In order to achieve the above object, a third aspect that the present invention can take is a mold for molding a gel member that covers an electrode element attached to a living body,
A recess containing a material for obtaining a gel member having adhesiveness and conductivity;
And a convex portion formed at the bottom of the concave portion.

  According to such a structure, a part of gel member obtained by shaping | molding can be made thinner than a peripheral part. By appropriately adjusting the dimensions of the convex portions, the contact surface with the living body finally obtained by mounting the gel member on the base material can be flat or have concave portions.

  In the case where the concave portion and the convex portion are formed by vacuum forming, the size of the convex portion can be easily and precisely adjusted, and the shape of the contact surface of the gel member can be easily and precisely determined.

In order to achieve the above object, a fourth aspect that the present invention can take is a method of manufacturing an electrode unit to be attached to a living body,
Prepare a mold having a recess and a protrusion formed on the bottom of the recess,
An ultraviolet curable material is accommodated in the recess,
Forming a gel member having adhesiveness and conductivity by irradiating the material with ultraviolet rays,
An electrode element is placed on the substrate,
The gel member is attached to the substrate so as to cover the electrode element.

  According to such a manufacturing method, an electrode unit having the above-described effects can be easily obtained.

It is a figure which shows the structure of the electrode unit which concerns on the 1st Embodiment of this invention. It is a figure which shows the structure of the electrode unit which concerns on the 2nd Embodiment of this invention. It is a longitudinal cross-sectional view which shows the structure of the apparatus for manufacturing the shaping | molding die of the gel member with which the electrode unit which concerns on this invention is provided. It is a figure which shows the structure of the shaping | molding die formed with said apparatus. It is a figure for demonstrating the manufacturing method of the electrode unit which concerns on this invention. It is a longitudinal cross-sectional view which shows the modification of the electrode unit which concerns on this invention.

  Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. In each drawing, the scale is appropriately changed to make each member a recognizable size.

  FIG. 1 shows a configuration of an electrode unit 1 according to the first embodiment of the present invention. The electrode unit 1 includes a base material 2, an electrode element 3, a covered conductive wire 4, and a gel member 5. 1A is a plan view showing an appearance of the electrode unit 1 as viewed from above, and FIG. 1B is a longitudinal section showing a configuration along line IB-IB in FIG. FIG.

  The base material 2 is made of an insulating material such as a nonwoven fabric or a resin, and has a circular appearance in plan view. An opening 2 a is formed at the center of the base material 2.

  The electrode element 3 has a disk-like appearance having a large-diameter portion 3a and a small-diameter portion 3b, and has at least a surface having conductivity. For example, a configuration in which the surface is molded with ABS resin and silver / silver chloride is coated on the surface, a configuration in which carbon fiber or the like is kneaded into the resin, and the like are conceivable. The large diameter portion 3a is disposed on the lower surface 2b as the first side of the substrate 2. The small diameter portion 3 b is inserted into the opening 2 a of the base material 2, and a part of the small diameter portion 3 b is disposed on the upper surface 2 c side as the second side of the base material 2.

  The coated conductor 4 has a configuration in which a conductive core wire is covered with an insulating coating. The core wire is physically and electrically connected to the electrode element 3 by ultrasonic welding.

  The gel member 5 is made of a material containing a monomer that forms an ultraviolet curable and hydrophilic polymer such as AMPS, for example, and has adhesiveness and conductivity. The gel member 5 is attached to the lower surface 2 b of the base material 2 so as to cover the electrode element 3.

  The electrode unit 1 is mounted so that the gel member 5 is in contact with the skin of the living body. Since the gel member 5 has elasticity and adhesiveness, it adheres while deforming along the skin surface. Thereby, the electrode unit 1 is hold | maintained on the skin surface of a biological body. The gel member 5 has conductivity. The biological information is electrically acquired through the gel member 5 and the electrode element 3, and is extracted as an electric signal through the coated conductor 4 as the signal extraction member of the present invention.

  The central part 5a covering the electrode element 3 in the gel member 5 is thinner than the peripheral part 5b. Here, the peripheral edge portion 5b means a portion including the peripheral edge 5c and the vicinity thereof.

  According to such a configuration, since the thin portion faces the electrode element 3, a step due to the thickness of the electrode element 3 hardly occurs between the central portion 5a and the peripheral portion 5b. Therefore, the contact surface 5d with the skin of the living body can be substantially flat over the entire surface, and the adhesion of the electrode unit 1 to the skin is improved.

  When the periphery of the gel member is thin as in the configuration described in Patent Document 1, the gel is dried at the portion, and peeling from the skin is likely to occur. In the present embodiment, since a sufficient amount of gel can be disposed on the peripheral edge portion 5b that is relatively thick, drying of the portion can be suppressed. This also improves the adhesion to the skin.

  Therefore, even if the size of the gel member 5 with respect to the electrode element 3 is relatively reduced by downsizing the electrode unit 1, it is possible to suppress a decrease in adhesion and to obtain a stable biological signal. Become. That is, both the miniaturization of the electrode unit 1 and the measurement stability can be achieved.

  Further, as shown in FIG. 1B, the large diameter portion 3a of the electrode element 3 is disposed on the lower surface 2b side (first side) of the substrate 2, while the small diameter portion 3b is disposed on the upper surface 2c of the substrate. (The second side opposite to the first side) is disposed, and the covered conductor 4 as a signal extraction member is also disposed on the upper surface 2c side.

  Therefore, the thickness of the electrode element 3 disposed on the lower surface 2b side of the substrate 2 on which the gel member 5 is mounted can be minimized. As a result, a step due to the electrode element 3 is less likely to occur on the contact surface 5d of the gel member 5, which contributes to improved adhesion to the skin.

  FIG. 2 shows a configuration of an electrode unit 1A according to the second embodiment of the present invention. Elements having the same or similar configurations and functions as those of the electrode unit 1 according to the first embodiment are denoted by the same reference numerals, and repeated description is omitted. 2A is a bottom view showing the external appearance of the electrode unit 1A as viewed from below, and FIG. 2B is a longitudinal sectional view showing the configuration along line IIB-IIB in FIG. FIG.

  The electrode unit 1A of the present embodiment is different from the gel member 5 of the electrode unit 1 according to the first embodiment in the shape of the gel member 5A. Specifically, in the contact surface 5d of the gel member 5A with the living body, a recess 5e is formed in a region excluding the peripheral edge 5c. Thereby, the center part 5a which covers the electrode element 3 of 5 A of gel members is made thinner than the peripheral part 5b.

  According to such a configuration, by pressing the gel member 5A against the skin of the living body, the concave portion 5e is crushed and air is released, so that a suction cup action can be generated on the contact surface 5d. Accordingly, the adhesion of the electrode unit 1A to the skin is improved.

  On the other hand, when removing the electrode unit 1A from the skin, only the peripheral portion 5b of the gel member 5A is peeled from the skin, so that the sucker action is lost, and the entire gel member 5A can be easily separated from the skin. . Since premature babies and newborns in a neonatal intensive care unit (NICU) have thin and soft skin, it is necessary to minimize the burden on the skin when attaching and detaching the electrode unit. According to the configuration of the present embodiment, while having excellent adhesion to the skin, the gel member 5A can be easily peeled / separated from the skin, so that the request can be sufficiently met.

  Moreover, since the sufficient quantity of gel can be arrange | positioned to the peripheral part 5b made relatively thick similarly to the electrode unit 1 which concerns on 1st Embodiment, the drying of the said location can be suppressed. This also improves the adhesion to the skin. Therefore, even when the size of the gel member 5A with respect to the electrode element 3 is relatively reduced by downsizing the electrode unit 1A, it is possible to suppress a decrease in adhesion and to obtain a stable biological signal. Become. That is, it is possible to achieve both size reduction and measurement stability of the electrode unit 1A.

  FIG. 3 is a longitudinal sectional view showing a configuration of an apparatus 10 for manufacturing a mold for forming the gel members 5 and 5A included in the electrode units 1 and 1A. The apparatus 10 is a vacuum forming apparatus having a known configuration, in which a first recess 11 is opened on the upper surface 10a, and a plurality of second recesses 12 are opened on the bottom thereof.

  The bottom surface 12a of each second recess 12 is convex upward. A plurality of insertion holes 12b are opened in the bottom surface 12a. A third recess 13 is opened in the lower surface 10b of the apparatus 10 and communicates with a suction pump (not shown). The plurality of insertion holes 12b communicate the third recess 13 and the second recess 12 respectively.

  The mold is manufactured by a known vacuum forming method. First, a raw material sheet 20 made of polyvinyl chloride (PVC), polyethylene terephthalate (PET), polystyrene (PS), acrylic, ABS resin, polycarbonate, polypropylene, polyethylene, ethylene vinyl acetate copolymer, etc. is placed on the upper surface 10a of the apparatus 10. And fixed. A release agent such as silicon is applied to the upper surface (the upper side in FIG. 3) of the raw material sheet 20.

  Next, when the suction pump communicating with the third recess 13 is operated in a state where the raw material sheet 20 is heated and softened, air is sucked through the communication hole 12b, and negative pressure is generated in the first recess 11 and the second recess 12. A state is formed. Thereby, the part which opposes the 1st recessed part 11 and the 2nd recessed part 12 of the raw material sheet | seat 20 is strongly attracted | sucked below, and is deform | transformed into the shape along each recessed part accompanying extending | stretching.

  The mold 30 thus obtained is shown in FIG. 4A is a plan view showing the appearance of the mold 30 as viewed from above, and FIG. 4B is a longitudinal sectional view showing the shape along line IVB-IVB in FIG. is there. Since the apparatus 10 shown in FIG. 3 includes the three second recesses 12, a molded product in which three molding dies 30 having the same shape are integrally connected can be obtained. FIG. 4 shows one of the obtained molds 30.

  The mold 30 includes a recess 32 that opens on the upper surface 31 a of the base 31. The recess 32 is defined by a peripheral wall 33 and a bottom wall 34. The base 31 is formed by the raw material sheet 20 that is deformed by vacuum molding so as to follow the first recess 11 of the apparatus 10.

  The peripheral wall 33 and the bottom wall 34 are formed by the raw material sheet 20 that is deformed along the second recess 12 of the apparatus 10 by vacuum forming. As described above, since the shape of the bottom surface 12 a of the second recess 12 is convex upward, the bottom wall 34 has a convex portion 34 a.

  The concave portion 32 of the mold 30 accommodates an ultraviolet curable liquid material for obtaining the gel members 5 and 5A. By irradiating the material with ultraviolet rays in this state, the material is cured to a certain degree of elasticity, adhesiveness, and conductivity. At this time, the peripheral wall 33 forms the peripheral edge 5c of the gel members 5 and 5A obtained. Moreover, the bottom wall 34 forms the contact surface 5d with the skin of the gel members 5 and 5A obtained. Since the convex part 34a is formed in the bottom wall 34, the center part 5a of the gel members 5 and 5A obtained is made thinner than the peripheral part 5b.

  The mold 30 formed from the raw material sheet 20 is coated with a release agent as described above. For this reason, the obtained gel members 5 and 5A can be easily peeled off from the shaping | molding die 30, and the shape loss of the gel members 5 and 5A can be avoided.

  Next, an assembly method of the electrode units 1 and 1A will be described with reference to FIG. First, the plurality of electrode elements 3 are arranged so as to coincide with the arrangement pitch of the mold 30 shown in FIG. Next, a single base material 2 on which a plurality of openings 2a are formed is covered, and the small diameter portion 3b of each electrode element 3 is fitted into the corresponding opening 2a.

  In this state, the tip of the coated conducting wire 4 is brought into contact with the small diameter portion 3b of the electrode element 3, and ultrasonic welding is performed using a known jig. Thereby, the front-end | tip part of the covered electric wire 4 melt | dissolves, and it connects with the electrode element 3 physically and electrically. Moreover, the base material 2 is fixed in a form sandwiched between the electrode element 3 and the covered electric wire 4. Here, the base material 2 is cut into a predetermined shape and separated into electrode units 1 and 1A.

  Next, as shown in FIG. 5B, the lower surface 2b of the base member 2 is brought into contact with the gel members 5 and 5A accommodated in the mold 30 and pressed with a predetermined force. Thereby, the upper surface 5f of the gel members 5 and 5A is deformed so as to cover the electrode element 3, and has a shape shown in FIG. 1B or 2B.

  By appropriately adjusting the diameter dimension and the height dimension of the convex portion 34a, it is possible to select either the shape shown in FIG. 1B or the shape shown in FIG. 2B. That is, by increasing the size of the convex portion 34a to some extent, the concave portion 5e can be finally left even if the contact surface 5d is deformed downward to absorb the thickness of the electrode element 3. In this case, an electrode unit 1A including the gel member 5A is obtained.

  Further, by making the size of the protrusion 34a somewhat smaller than in the above case, the contact surface 5d is deformed downward so as to absorb the thickness of the electrode element 3, so that the contact surface 5d is finally flattened. Can do. In this case, the electrode unit 1 provided with the gel member 5 is obtained.

  As described above, the mold 30 is formed by the apparatus 10 by vacuum molding. Since the dimension of the convex part 34a is determined based on the shape of the bottom surface 12a of the second concave part 12 of the device 10, the dimension of the convex part 34a can be adjusted easily and precisely by appropriately designing the shape of the bottom surface 12a. Therefore, the shape of the contact surface 5d of the gel members 5 and 5A can be determined easily and precisely.

  Next, the electrode units 1 and 1A with the gel members 5 and 5A attached thereto are taken out of the mold 30 and a release paper (not shown) is attached to the gel members 5 and 5A to protect the gel members 5 and 5A from drying and damage. .

  The above embodiment is for facilitating understanding of the present invention, and does not limit the present invention. The present invention can be modified and improved without departing from the spirit of the present invention, and it is obvious that the present invention includes equivalents thereof.

  In the gel member 5 </ b> A of the electrode unit 1 </ b> A according to the second embodiment, the portion (recessed portion 5 e) that is thinner than the peripheral edge portion 5 b is necessarily formed so as to include all the portions that cover the electrode element 3. I don't need it. A part of the portion covering the electrode element 3 may be thinned as long as it is formed in a region excluding the peripheral edge 5c and can generate a sucker action when attached to a living body.

  In the gel member 5A of the electrode unit 1A according to the second embodiment, the recess 5e is not necessarily provided at a position covering the electrode element 3. As long as the gel member 5B included in the electrode unit 1B shown in FIG. 6 (a) is formed in a region excluding the peripheral edge 5c and can generate a sucker action when attached to a living body, the electrode element 3 is provided. It is good also as a structure by which the recessed part 5e is formed in the part which is not covered. Further, it is not always necessary to form only one recess 5e. As shown in the figure, a plurality of recesses 5e may be formed as long as they are formed in a region excluding the peripheral edge 5c.

  The signal extraction member for extracting the biological signal is not limited to the covered conductor 4. As in the electrode element 3A included in the electrode unit 1C shown in FIG. 6B, the terminal 4A is caulked to the small diameter portion 3b ′ with the base material 2 sandwiched between the large diameter portion 3a and the conductive terminal 4A. It is good also as a structure. In this case, a biological signal is taken out with the terminal 4A sandwiched between clips connected with lead wires and the like. The present invention can also be applied to the configuration of the electrode unit 1 according to the first embodiment.

  The shape of the electrode elements 3 and 3A is not limited to the configuration shown in the above embodiment. A sheet electrode made of a carbon sheet or the like can be used as long as it has electrical conductivity and biological information can be electrically acquired.

  The shapes of the base material 2 and the gel members 5 and 5A are not limited to the circular shape in plan view. An appropriate shape can be taken according to the use of the electrode unit. For example, the base material 2 may have a circular shape in plan view, and the gel members 5 and 5A may have a rectangular shape in plan view. The reverse is also possible.

  DESCRIPTION OF SYMBOLS 1, 1A: Electrode unit, 2: Base material, 2b: The lower surface of a base material, 2c: Upper surface of a base material, 3, 3A: Electrode element, 4: Covered conducting wire, 4A: Terminal, 5, 5A: Gel member, 5a : Center part of the gel member, 5b: Peripheral part of the gel member, 5c: Periphery of the gel member, 5d: Contact surface of the gel member, 5e: Concave part of the gel member, 10: Manufacturing apparatus of the mold, 30: Mold 32: concave part of mold, 34a: convex part of mold

Claims (3)

An electrode unit mounted on a living body,
A substrate;
An electrode element disposed on the substrate;
A signal extraction member electrically connected to the electrode element;
A gel member attached to the base material so as to cover the electrode element and having adhesiveness and conductivity,
At the time of mounting on the living body, only the gel member is configured to come into contact with the skin of the living body,
Surface contacting the living body of the gel member is a flat region including the periphery, Ru least one recess is formed Tei at a position distant from the peripheral edge than the region that is with the flat on the surface , Electrode unit.   The at least part of the electrode element is disposed on a first side of the base material, and the signal extraction member is disposed on a second side opposite to the first side of the base material. 2. The electrode unit according to 1. It is a manufacturing method of the electrode unit according to claim 1 or 2,
Prepare a mold having a recess and a protrusion formed on the bottom of the recess,
An ultraviolet curable material is accommodated in the recess,
Irradiating the material with ultraviolet rays to form the gel member,
An electrode element is placed on the substrate,
The manufacturing method of mounting | wearing the said base material so that the said electrode member may be covered with the said electrode element.

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