JPH0331448B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Application Field] The present invention relates to a method and apparatus for producing a pad for a bioelectrode, particularly a pad for a bioelectrode having a two-layer structure with an insulating base sheet interposed therebetween.

[Conventional technology]

(1) Background of the Invention In general, a bioelectrode pad is formed of a hydrous gel layer that has both conductivity and adhesiveness, and as shown by reference numeral 30 in FIG. One surface 42 is adhered to the electrode plate 20 connected to the body, and the other surface 41 is brought into close contact with the skin surface 50 of the living body. In this way, pad 3
The electrode plate 20 is connected to a living body through the 0, and electrical phenomena inside the living body are derived (biological induction electrode) and input to the medical device 10 (for example, when obtaining a body surface electrocardiogram), or vice versa. Stimulation is introduced into the living body from the medical device 10 (biological stimulation electrode) to treat the living body (for example, treatment of stiff shoulders using a low frequency treatment device).

However, since this pad 30 is brought into close contact with the skin of many patients, it is desirable to make it disposable for hygiene reasons.

For this reason, the pad 30 is attached to the living body side hydrogel layer 30.
A and an electrode-side hydrogel layer 30B have a two-layer structure, and an insulating base sheet 60 is sandwiched between them, with the tip thereof serving as a gripping piece 40. By holding this gripping piece 40 with the fingers of the hand, the electrode plate 20 can be attached to the electrode plate 20. On the other hand, there are some that are easier to attach and detach.

Furthermore, as shown in FIG. 8B, in addition to the gripping piece 400, the pad is made into a two-layer structure through an insulating base sheet 300 constituting the connecting member 330, and the two pads 100 and 200 are connected. There is a type of electrode plate 500 and 600 of the compact low frequency treatment device main body 700 that can be easily and quickly attached and detached.

In particular, the latter two pads connected together has already been disclosed as a "biological stimulation electrode pad" in a utility model registration application filed by the applicant of the present application on December 7, 1962.

The present invention relates to a method and apparatus for producing a pad for a bioelectrode having a two-layer structure with an insulating base sheet interposed therebetween, regardless of whether it is a bioinduction electrode or a biostimulation electrode.

(2) Conventional example The conventional method for manufacturing bioelectrode pads is 2.
There are two methods: the first method is to use a porous and insulating base sheet (Figure 9), and the second method is to use an insulating base sheet, regardless of whether it is porous or not. (Fig. 11).

The first conventional technique (Fig. 9) is that in its first step A,
Lower formwork K2 in which multiple rows of recesses 1', 2'...n' are formed
A porous and insulating base sheet 300 is placed on top so that it covers each recess, and in a second step B,
An upper formwork K1 in which through holes 1, 2...n are formed corresponding to the respective recesses is placed on the base sheet 300, and K1 and K2 are brought into close contact with each other through the base sheet 300. In Step 3 C, conductive and sticky hydrogel stock solutions S1, S2...Sn are poured through the through holes,
The stock solution on the recess side and the through-hole side are communicated through the holes in the base sheet 300, and in the fourth step D, the stock solution is solidified by irradiation with ultraviolet rays and communicated with each other through the holes in the base sheet. Conductive and adhesive hydrogel layer on the living body side and hydrogel layer on the electrode side G11 and G1 to be combined
2. G21 and G22...Gn1 and Gn2 in multiple rows,
In the fifth step E, a predetermined punching form k11,
k12...knn integrates the hydrous gel layer and base sheet on the living body side and the electrode side to form pads P11, P1.
2...It is designed to punch out Pnn.

In addition, the second prior art (Fig. 11)
In step A, a plurality of insulating base material sheets 3001, 300 are placed on the first formwork K1 in which a plurality of rows of recesses 1, 2...n are formed, so that adjacent recesses are exposed.
2...300 (n-1) (arrow A in Figure 11)
1, A2...A(n-1)), each insulating base material sheet is sandwiched between second formworks K2 and K1 in which corresponding recesses 1', 2'...n' were formed in the second step B, In the third step C, conductive and sticky hydrogel stock solutions S11, S12... are poured into the openings of each recess 1, 1', 2, 2'...n, n', and the corresponding recesses 1, 1', 2 and the stock solution on the 2' side are communicated along the end surface of each base sheet, and the fourth step D
Then, the above stock solution is solidified by irradiation with ultraviolet rays, and a conductive and adhesive hydrogel layer on the biological side and a hydrogel layer on the electrode side G11, G12, and G21 are bonded to each other along the end surface of each base sheet. and G22..., and in the fifth step E, predetermined punching forms k11,k are formed.
12...Knn integrates the hydrous gel layer and base sheet on the living body side and the electrode side into pads P11 and P12.
...It is starting to punch out Pnn.

[Problem that the invention seeks to solve]

In the first and second conventional techniques described above (FIGS. 9 and 11), a long band-shaped hydrogel layer is continuously formed. Therefore, after punching in the fifth and final step E, wasteful parts remain as shown by diagonal lines in FIG. 12, resulting in poor yield.

That is, in the first conventional technique (FIG. 13A), a plurality of rows of hydrogel layers formed at equal intervals on one base sheet 300 are punched out as shown by broken lines.
Make pads P11, P12... However, the shaded portion of the integrated product consisting of the hydrous gel layer and the base sheet does not have any gripping pieces, or so-called ears, made of only the base sheet, so it is completely useless as a pad.

Furthermore, in the second prior art (FIG. 13B), pads P11, P12, etc. are made by punching out two rows of hydrogel layers from each of a plurality of base sheets 3001, 3002, etc., as shown by broken lines. In this case, as in the first prior art (FIG. 13A), the shaded area is completely useless as a two-layer pad with a base sheet sandwiched therebetween since it has no ears.

Next, in both of the above-mentioned conventional techniques, not only the hydrous gel layer that is to become a pad but also the exposed base sheet portion is formed continuously in a long band shape. Therefore, it is suitable for punching out two pads connected by a base sheet, but it is not suitable for punching out various shapes of ears with gripping pieces from one pad, and the versatility is limited. There is no.

Furthermore, as is clear from FIG. 10 and FIG.
0), it is perpendicular to the base sheet, whereas in the latter (Fig. 12) it is parallel. Moreover, in the first conventional technique, the device is placed horizontally and used.
In the second prior art, the device must be placed vertically. In other words, in the past, the equipment used was different;
The handling was extremely complicated.

In short, conventional products have had problems such as low yield and lack of versatility, complicated handling of the equipment used, and extremely low efficiency when manufacturing bioelectrode pads with a two-layer structure. Ta.

An object of the present invention is to improve the manufacturing efficiency of a bioelectrode pad having a two-layer structure via an insulating base sheet.

[Means for solving problems]

The above problems are as follows: (1) In the first step, a porous and insulating base sheet is placed on the upper surface of the lower formwork in which at least two pairs of recesses are formed, so as to cover each recess. In the second step, the lower surface of the upper formwork in which two pairs of through holes are formed corresponding to the two pairs of recesses is placed on the base sheet, and the upper surface of the lower formwork and the upper formwork are separated. The lower surface of the third
In the step, a conductive and sticky hydrogel stock solution is injected through the through-hole, and the stock solution on the recess side and the stock solution on the through-hole side are communicated through the holes in the base sheet, and in the fourth step, The above stock solution is solidified to form a conductive and adhesive hydrogel layer on the living body side and a hydrogel layer on the electrode side, which are interconnected through the holes in the base sheet. A pad for a bioelectrode, characterized in that the upper mold is removed and the pad is punched out using a predetermined punching mold, combining the above-mentioned living body side hydrogel layer, electrode side hydrogel layer, and base sheet as one body. (2) In the first step, an insulating base sheet is placed on the upper surface of the lower formwork in which at least two pairs of recesses are formed, so that each recess is exposed; In the process, the lower surface of the upper formwork, in which two pairs of through holes are formed corresponding to the two pairs of recesses, is placed on the base sheet, and the upper surface of the lower formwork and the lower surface of the upper formwork are separated. are brought into close contact with each other through the base sheet, and the upper and lower surfaces are brought into close contact with each other. In the third step, a conductive and sticky hydrogel stock solution is injected through the through hole, and the stock solution on the recess side and the through hole are injected. The stock solution on the hole side is communicated with the solution along the end surface of the base material sheet, and in the fourth step, the stock solution is solidified to form a conductive and sticky biological side water-containing material that is mutually bonded along the end surface of the base material sheet. A gel layer and an electrode-side hydrogel layer are formed, and a fifth
In the step, the lower formwork and the upper formwork are removed and the base sheet is cut. In the fifth step, the lower formwork and the upper formwork are removed and the base sheet is cut. A method for producing a pad for a bioelectrode, characterized in that the pad is formed by integrating the hydrogel layer on the living body side, the hydrogel layer on the electrode side, and the base material sheet; a lower formwork formed with at least two pairs of recesses to receive the hydrogel stock solution;
an upper formwork formed with at least two pairs of through holes corresponding to the recesses and into which the stock solution is to be injected; The problem is solved by a bioelectrode pad manufacturing apparatus characterized in that the upper surface and the lower surface can be brought into close contact with each other via an insulating base sheet inserted between the upper surface and the lower surface.

[Effect]

According to the present invention, after the poured stock solution is solidified by the at least two pairs of recesses and the corresponding through holes, the hydrogel layer 110 having a two-layer structure
A, 120A... are intermittently formed on the base sheet 300 (FIG. 4A). Therefore, according to the first invention (the left diagram in FIG. 4A), only the base sheet in the shaded area is wasted, and according to the second invention (the left diagram in FIG. 4A), only the base sheet in the shaded area is wasted.
13), there was no waste at all, and the yield was significantly improved compared to the conventional technology (FIG. 13A and B), in which both the hydrogel layer and the base sheet were wasted.

Further, according to the present invention, not only the connection pad P8 shown in FIG. 4B, but also the induction electrode pads L1 and L2 and the stimulation electrode pad S as shown above
1. A composite pad P7 can also be manufactured by punching out S2 and the base sheet as one piece. On the one hand, it is also possible to produce single pads P9 to P14 in which the single pads P1 to P6 have changed their shape. Therefore, the versatility is greatly improved compared to the conventional technology which can only manufacture connecting pads.

Furthermore, in the present invention, since the same device (Fig. 3) is used in both the first and second inventions (Figs. 1 and 2), the width dimension of the insulating base sheet 300 and its recess 1110, 1120..., the direction of injecting the stock solution and the installation direction of the device are the same, and the handling of the device is easier than with the conventional technology, which requires the use of different devices (Figures 10 and 12). It became very easy.

Therefore, according to the present invention, the production efficiency of a bioelectrode pad having a two-layer structure via an insulating base sheet can be improved.

〔Example〕

The invention will now be explained by way of example with reference to the accompanying drawings.

(1) First invention First step (Fig. 5A) Two or more pairs of recesses 11101, 11
201... is formed in the lower formwork 1000 (seventh
A porous and insulating base material sheet 300 is placed on the upper surface 1100 of the figure so as to cover each recess.

This base sheet is made of woven fabric, knitted fabric, or the like.

Second step (FIG. 5B) An upper formwork (Fig. 8) in which through holes 21101, 21201... are formed corresponding to the recesses is placed on the base sheet 300, and the upper surface 1100 of the lower formwork is and the lower surface 2100 of the upper formwork are brought into close contact with each other via the base sheet 300.

Third step (FIG. 5C) Conductive and adhesive acrylic hydrogel stock solutions G1, G2, etc. are injected through the through-holes, and the stock solutions on the recess side and the through-hole side are passed through the holes in the base sheet 300. to communicate.

The reason why an acrylic hydrogel stock solution is used is that it has the most desirable advantage as a gel layer forming a pad, that is, it is difficult to dry for a long time.

Fourth step (FIG. 5D) The above stock solution is irradiated with ultraviolet rays as shown by the arrow to solidify it, and it has conductivity and adhesiveness and is bonded to each other through the holes in the base sheet 300. A living body side hydrogel layer and an electrode side hydrogel layer are formed.

Fifth step (Fig. 5E) Finally, predetermined punching forms k1, k2...kn
Accordingly, the hydrogel layer and base sheet on the living body side and the electrode side are punched out as one body to form pads P1, P2, . . . Pn.

As a result, as shown in Fig. 4A and B,
Yields were improved because the base sheet was wasted, and by selecting a punching form instead of just connecting pads, pads of various shapes could be made, increasing versatility.

(2) Second invention First step (Fig. 6A) Using the same apparatus as the above first invention (Fig. 7),
The difference is that it does not matter whether the base sheet is porous or not, and the way it is placed is in the recess 1110.
1, 11201... are exposed, a plurality of elongated base material sheets 300 as shown in the figure are formed.
1,3002...300n.

Second step (Fig. 6B) The upper formwork 2000 is placed in the same way as in the first invention, but the method of close contact is not only through the base sheet but also between the lower surface of the upper form and the upper surface of the lower form. The difference is that it involves the act of bringing them into direct contact.

Third step (FIG. 6C) This invention differs from the first invention in that the stock solution on the recess side and the through hole side is communicated along the end surface of the base sheet. When a porous base sheet is used, communication occurs through each hole.

Fourth step (FIG. 6D) This invention differs from the first invention in that hydrogel layers on the living body side and the electrode side are formed mutually bonded along the end surface of the base sheet. If a porous base sheet is used, they will be interconnected through each hole.

Fifth step (FIG. 6E) The difference from the first invention is that the pads P1, P2, .

According to the second invention, as explained in the right diagram of FIG. 4A, there is no wasted part and the yield is 100%.

(3) Third Invention As is clear from FIG. 7, the device used in the first and second inventions is one in which two or more pairs of recesses 11101, 11201... are formed in the lower formwork 1000, An upper formwork 2000 in which through holes 21101, 21201, .
Screw holes N1 to N4 are formed in the upper formwork 2000, and corresponding holes n1 to n4 are formed in the upper formwork 2000, and screws (not shown) connect the upper and lower surfaces directly to the base sheet 300 or 3001, 3.
002...300n allows for close contact.

According to the third invention, the same device is used in the first and second inventions, and the installation direction of the device and the direction of injection of the stock solution are completely the same, making the device extremely easy to handle.

〔Effect of the invention〕

As mentioned above, the first and second inventions improve the yield and the versatility compared to the past, and the third invention makes the device easier to handle than before, and the two-layer structure can be realized through an insulating base sheet. The technical effect of improving the manufacturing efficiency of bioelectrode pads has been achieved.

[Brief explanation of the drawing]

Fig. 1 is a principle diagram of the first invention, Fig. 2 is a principle diagram of the second invention, Fig. 3 is a principle diagram of the third invention, Fig. 4 is an explanatory diagram of the operation of the present invention, and Fig. 5 is a diagram of the principle of the second invention. A diagram showing an embodiment of the invention, FIG. 6 is a diagram showing an embodiment of the second invention,
FIG. 7 is a diagram showing an embodiment of the third invention, FIG. 8 is a general explanatory diagram of a two-layer pad, FIG. 9 is a diagram showing a manufacturing method of the first prior art, and FIG. 10 is a diagram showing the first prior art. FIG. 11 is a diagram showing the manufacturing method of the second prior art, FIG. 12 is a diagram showing the configuration of the device used in the second prior art, and FIG. 13 is a diagram explaining problems with the prior art. be. 110A and 120A, 210A and 220A, 1
10B and 120B, 210B and 220B...Living body side hydrogel layer and electrode side hydrogel layer, 300...Insulating base sheet, 1000...Lower formwork, 2000
...Top formwork, 1100...Top surface, 2100...Bottom surface, 1110 and 1120, 1130 and 1140...
...Two pairs of recesses, 2100 and 2120, 2130 and 2140...Two pairs of through holes, 311, 312...
End face, G1 and G2, G3 and G4... Hydrogel stock solution, kA, kB... Punching form, PA, PB... Padded.

Claims (1)

[Claims] 1. In the first step (A), at least two pairs of recesses 11
10 and 1120, 1130 and 1140 are formed on the upper surface 1100 of the lower formwork 1000, a porous and insulating base material sheet 30 is placed so as to cover each recess.
0, and in the second step (B), on the base sheet 300,
Two pairs of through holes 2110 corresponding to the two pairs of recesses described above.
2120, 2130, and 2140 are placed on the lower surface 2100 of the upper mold 2000, and the upper surface 1100 of the lower mold and the lower surface 2100 of the upper mold are brought into close contact with each other via the base sheet 300, and the third step In (C), conductive and sticky hydrogel stock solutions G1, G2, G3 and G4 are injected through the through holes, and the stock solutions on the recess side and the stock solution on the through hole side are mixed into the holes 301 of the base sheet. 302..., and in the fourth step (D), the above-mentioned stock solution is solidified to form a conductive and adhesive biological-side hydrogel bonded to each other via the holes 301, 302... of the base sheet 300. Layer and electrode side hydrogel layer 110A and 120A, 210A and 220A, 110B and 120B, 210B and 22
0B is formed, and in the fifth step (E), the lower mold and the upper mold are removed, and the living body side hydrogel layer, the electrode side hydrogel layer, and the base material are cut using predetermined punching molds kA and kB. A method for manufacturing a bioelectrode pad, characterized in that pads PA and PB are punched out together with a sheet. 2 In the first step (A), at least two pairs of recesses 11
An insulating base material sheet 300 is placed on the upper surface 1100 of the lower formwork 1000 on which the shapes 10 and 1120, 1130 and 1140 are formed, so that each recess is exposed. On the material sheet 300,
Two pairs of through holes 2110 corresponding to the two pairs of recesses described above.
2120, 2130, and 2140 are placed on the lower surface 2100 of the upper mold 2000, and the upper surface 1100 of the lower mold and the lower surface 2100 of the upper mold are brought into close contact with each other via the base sheet 300. In the third step (C), conductive and sticky hydrogel stock solutions G1 and G2, G3 and G4 are injected through the through holes, and the stock solutions on the recess side and the stock solution on the through hole side are injected. In the fourth step (D), the stock solution is solidified, and the conductive and conductive materials are connected to each other along the end surfaces 311 and 312 of the base sheet 300. Adhesive living body side hydrogel layer and electrode side hydrogel layer 110A and 120A, 210A and 220A, 110B and 120B, 210B and 22
0B, and in the fifth step (E), the lower formwork and the upper formwork are removed and the base sheet 300 is cut, thereby forming the living body side hydrogel layer, the electrode side hydrogel layer, and the base material. A method for manufacturing a bioelectrode pad, characterized in that pads PA and PB are integrally formed with a material sheet. 3 At least two pairs of recesses 1110 and 1120, 11 to receive conductive and sticky hydrogel stock solution
30 and 1140, and at least two pairs of through holes 2110, 2120, 213 corresponding to the recesses and into which the stock solution is to be injected.
0 and 2140, the upper surface 1100 of the lower formwork 1000 and the upper formwork 2
Insulating base material sheet 30 that allows the lower surface 2100 of 000 to be brought into close contact with the lower surface 2100 and is inserted between the upper surface and the lower surface.
1. An apparatus for manufacturing a pad for a bioelectrode, characterized in that an upper surface and a lower surface can be brought into close contact with each other through a pad.