JP2024049144A - Medical instruments, medical sheets, bioelectrodes - Google Patents

Abstract

[Problem] To provide a medical device capable of reducing the effect of static electricity on a bioelectrode. [Solution] A medical device having a bioelectrode and a connector, in which the bioelectrode includes a substrate having an electrode element, a connected portion, an insulating member, and a shield layer including a conductive material, and the connector includes a connection portion and a housing formed of a conductive material, and in a state in which the bioelectrode and the connector are connected, the shield layer and the housing are in contact with each other. [Selected Figure] Figure 6

Description

The present invention relates to medical devices, medical sheets, and bioelectrodes.

There are bioelectrodes for receiving electrical signals corresponding to bioinformation (e.g. electrocardiogram, pulse wave, brain wave, electromyogram). Bioelectrodes are attached to the surface of the subject's body.

Patent document 1 discloses a bioelectrode that includes an electrode element with a conductive gel layer adhered to one end and a tape that holds the other end of the electrode element and is attached to the surface of a living body.

JP 2000-271100 A

When receiving electrical signals with a bioelectrode, the effect of noise caused by static electricity discharge (hereinafter sometimes referred to as "the effect of static electricity") can be a problem. Static electricity discharge occurs, for example, when the bioelectrode comes into contact with the subject's clothing.

The objective of the present invention is to provide a technology that can reduce the effects of static electricity on bioelectrodes.

One invention for achieving the above object is a medical device having a bioelectrode that is attached to the body surface of a living organism and receives an electrical signal corresponding to bioinformation, and a connector for transmitting the electrical signal received by the bioelectrode to an external device, wherein the bioelectrode includes an electrode element, a connected portion that is connected to the electrode element and connects the bioelectrode to the connector, an insulating member that covers the electrode element and has a first hole through which the connected portion passes, and a substrate that covers the insulating member and has a shielding layer containing a conductive material on the opposite side to the side that contacts the insulating member, and the connector includes a connection portion for connecting the connector to the bioelectrode, and a housing that contains the connection portion and is formed of a conductive material, and when the bioelectrode and the connector are connected, the shielding layer and the housing are in contact with each other.
Another invention for achieving the above object is a medical device having a bioelectrode that is attached to the body surface of a living body and receives an electrical signal corresponding to bioinformation, and a connector for transmitting the electrical signal received by the bioelectrode to an external device, the bioelectrode including an electrode element, a connected portion that is connected to the electrode element and connects the bioelectrode to the connector, an insulating member that covers the electrode element and has a first hole through which the connected portion passes, and a substrate that covers the insulating member and has a shielding layer that includes a conductive material on the side opposite to the side that contacts the insulating member, the connector including a connecting portion for connecting the connector to the bioelectrode, the medical device including a shielding member that is formed of a conductive material and that covers the connector when the bioelectrode and the connector are connected, and the shielding layer and the shielding member are in contact when the bioelectrode and the connector are connected.
Another invention for achieving the above object is a medical device having a bioelectrode that is attached to the body surface of a living body and receives an electrical signal corresponding to bioinformation, and a connector for transmitting the electrical signal received by the bioelectrode to an external device, the bioelectrode including an electrode element, a connected portion that is connected to the electrode element and connects the bioelectrode to the connector, an insulating member that covers the electrode element and has a first hole through which the connected portion passes, and a substrate that covers the insulating member and has a shielding layer containing a conductive material on the opposite side to the side that contacts the insulating member, the connector including a connecting portion for connecting the connector to the bioelectrode, and a housing that contains the connecting portion and is made of a conductive material, the medical device further including a shielding member that covers the connector when the bioelectrode and the connector are connected, and the housing and the shielding member each contact the shielding layer when the bioelectrode and the connector are connected.
Another invention for achieving the above-mentioned object is a medical sheet for covering a medical instrument attached to a living body, the medical sheet having an adhesive layer for attaching the medical sheet to the body surface of the living body, and a shielding layer containing a conductive material and covering the adhesive layer.
Another invention for achieving the above-mentioned object is a bioelectrode for being attached to the body surface of a living organism and receiving an electrical signal from the living organism, comprising: a conductive member having a predetermined length; a connected portion provided at one end of the conductive member for connecting the bioelectrode to the connector; an insulating member having a third hole through which the connected portion passes and covering the conductive member; and a sheet member containing a conductive material, wherein the sheet member has a first shielding region fixed to the side opposite to the side on which the third hole of the insulating member is formed, and a second shielding region for covering the connector when the connector is connected.
Other features of the present invention will become apparent from the following specification and drawings.

The present invention can reduce the effects of static electricity on bioelectrodes.

FIG. 2 is a schematic diagram showing a bioelectrode according to the first embodiment. FIG. 2 is a schematic diagram showing a bioelectrode according to the first embodiment. 1 is a schematic diagram showing a connector according to a first embodiment. FIG. 1 is a schematic diagram showing a connector according to a first embodiment. FIG. FIG. 1 is a schematic diagram showing a medical device according to a first embodiment. FIG. 1 is a schematic diagram showing a medical device according to a first embodiment. FIG. 11 is a schematic diagram showing a connector according to a second embodiment. FIG. 11 is a schematic diagram showing a connector according to a second embodiment. 6A and 6B are schematic diagrams illustrating a shielding member according to a second embodiment. FIG. 6 is a schematic diagram showing a medical device according to a second embodiment. FIG. 6 is a schematic diagram showing a medical device according to a second embodiment. FIG. 13 is a schematic diagram showing a bioelectrode according to a third embodiment. FIG. 13 is a schematic diagram showing a bioelectrode according to a third embodiment. FIG. 11 is a schematic diagram showing a medical sheet according to a third embodiment. FIG. 11 is a schematic diagram showing a medical sheet according to a third embodiment. 13 is a schematic diagram showing a medical sheet and a medical device according to a third embodiment. FIG. 13 is a schematic diagram showing a medical sheet and a medical device according to a third embodiment. FIG. FIG. 13 is a schematic diagram showing a bioelectrode according to a fourth embodiment. FIG. 13 is a schematic diagram showing a bioelectrode according to a fourth embodiment. FIG. 13 is a schematic diagram showing a medical device according to a fourth embodiment. FIG. 13 is a schematic diagram showing a medical device according to a fourth embodiment.

First Embodiment
A medical device 1 according to a first embodiment will be described with reference to Figures 1 to 6. Figure 1 is a view of a bioelectrode 10 as viewed from the front side (described later). Figure 2 is an A-A' cross-sectional view of the bioelectrode 10 shown in Figure 1. Figure 3 is a view of a connector 20 as viewed from the front side (described later). Figure 4 is a B-B' cross-sectional view of the connector 20 shown in Figure 3. Figure 5 is a perspective view showing a state in which the bioelectrode 10 and the connector 20 constituting the medical device 1 are connected. Figure 6 is a C-C' cross-sectional view of the bioelectrode 10 and the connector 20 shown in Figure 5.

==Medical Equipment==
The medical device is used to receive an electrical signal corresponding to biological information from a subject and transmit the electrical signal to an external device. The medical device 1 according to the present embodiment includes a biological electrode 10 and a connector 20.

The bioelectrode 10 is attached to the body surface of a living organism and is configured to receive electrical signals corresponding to bioinformation. Examples of bioinformation include electrocardiograms, pulse waves, brain waves, and electromyograms.

The connector 20 is configured to transmit the electrical signal received by the bioelectrode 10 to an external device. The external device may be a transmitter for a medical telemeter or a bioinformation monitor such as an electrocardiograph.

In this embodiment, the side of the bioelectrode 10 that is attached to the living body and the side of the connector 20 that is connected to the bioelectrode 10 are referred to as the "back side," and the opposite sides are referred to as the "front side." In addition, the direction perpendicular to the front-back direction is referred to as the "width direction."

[Bioelectrode]
As shown in FIGS. 1 and 2 , a bioelectrode 10 according to this embodiment includes an electrode element 11 , a transmission member 12 , a connected portion 13 , an insulating member 14 , and a substrate 15 .

(Electrode element)
The electrode element 11 receives bioinformation emitted by a living body as an electric signal. The electrode element 11 is provided at a position where it can indirectly contact the body surface via the transmission member 12 when the bioelectrode 10 is attached to the body surface of a living body. The electrode element 11 according to this embodiment is disposed so that its front surface contacts the rear surface of the insulating member 14 (see FIG. 2).

The electrode element 11 is made of a material that can conduct electrical signals, such as a metal.

The size and shape of the electrode element 11 are not particularly limited, but since it may be attached to the body surface for a long period of time, a flat shape (a shape with a thin thickness in the front and back directions) is preferable. The electrode element 11 in this embodiment is disc-shaped (see Figures 1 and 2).

(Transmission member)
The transmission member 12 transmits an electrical signal of bioinformation generated by the living body to the electrode element 11. The transmission member 12 is provided at a position that directly contacts the body surface when the bioelectrode 10 is attached to the body surface of the living body. The transmission member 12 according to this embodiment is disposed so that its front surface contacts the rear surface of the electrode element 11 (see FIG. 2).

The transmission member 12 is composed of, for example, an electrode paste or gel that is mainly composed of an electrolyte.

The size and shape of the transmission member 12 are not particularly limited, but it is preferable that the size and shape are the same as or larger than the electrode element 11 so that the electrode element 11 does not directly contact the body surface. The transmission member 12 in this embodiment is disc-shaped with a larger diameter than the electrode element 11 (see Figures 1 and 2).

(Connected part)
The connected portion 13 is a portion for connecting the bioelectrode 10 to the connector 20. By connecting the bioelectrode 10 to the connector 20, electrical conduction is established. Therefore, the bioelectrode 10 can output the received electrical signal to the connector 20. The connected portion 13 is connected to the electrode element 11. In this embodiment, the connected portion 13 is provided in the center of the surface of the electrode element 11 and is formed integrally with the electrode element 11 (see FIG. 2). In addition, the connected portion 13 is composed of a thin-diameter portion that connects to the electrode element 11 and a head portion having a diameter larger than that of the thin-diameter portion (see FIG. 2). Furthermore, the connected portion 13 penetrates a hole 14a formed in the insulating member 14 and a hole 15c formed in the base material 15, and protrudes to the front side (see FIGS. 1 and 2).

The connected portion 13, like the electrode element 11, is made of a material that can conduct electrical signals, such as a metal.

The size and shape of the connected portion 13 correspond to the connecting portion 21 (described below) of the connector 20. The connected portion 13 in this embodiment has a convex shape (corresponding to the convex part of a hook) (see Figures 1 and 2).

(Insulating material)
The insulating member 14 insulates the electrode element 11 and the connected portion 13 from the substrate 15. The insulating member 14 is provided between the electrode element 11 and the substrate 15. The insulating member 14 has a hole 14a formed therein. The hole 14a is a portion through which the connected portion 13 penetrates. The insulating member 14 according to this embodiment has a hole 14a formed in the center (see FIG. 2). The insulating member 14 according to this embodiment is also disposed so that its back surface contacts the front surface of the electrode element 11, and a part of its front surface contacts the back surface of the substrate 15 (see FIG. 2). The hole 14a is an example of a "first hole".

The insulating member 14 is made of an insulating material such as polyvinyl chloride resin or acrylic resin.

The size and shape of the insulating member 14 are not particularly limited, but are preferably the same as or larger than the electrode element 11 so that the electrode element 11 and the connected portion 13 do not come into contact with the substrate 15. The insulating member 14 according to this embodiment is disk-shaped with a larger diameter than the electrode element 11 (see Figures 1 and 2). The size and shape of the hole 14a are not particularly limited as long as it is large enough for the connected portion 13 to pass through. The size and shape of the hole 14a according to this embodiment are approximately the same as the narrow diameter portion of the connected portion 13 (see Figure 2).

(Base material)
The substrate 15 is a member for attaching the bioelectrode 10 to the body surface. The substrate 15 is provided so as to cover the insulating member 14. That is, the electrode element 11, the transmission member 12, and the insulating member 14 are arranged on the back side of the substrate 15. The substrate 15 has a hole 15c formed therein. The hole 15c is a portion through which the connected portion 13 penetrates. The substrate 15 according to this embodiment has a hole 15c formed in the center (see FIGS. 1 and 2). In addition, the substrate 15 according to this embodiment is arranged so as to cover a part of the insulating member 14 (a region other than the center of the insulating member 14) (see FIGS. 1 and 2). The hole 15c is an example of a "second hole".

The size and shape of the substrate 15 are not particularly limited as long as they are large enough to cover the insulating member 14, but are preferably in a shape without corners (for example, a perfect circle or ellipse) so that they are not easily peeled off from the body surface. The substrate 15 according to this embodiment is disk-shaped with a diameter larger than that of the electrode element 11, the transmission member 12, and the insulating member 14 (see Figures 1 and 2). The size and shape of the hole 15c formed in the substrate 15 are not particularly limited as long as the edge of the hole 15c does not come into contact with the connected portion 13 when the insulating member 14 is covered by the substrate 15 (when the connected portion 13 penetrates the hole 15c). In this case, since the substrate 15 and the connected portion 13 do not come into direct contact with each other, the electrical signal received by the electrode element 11 can be prevented from flowing to the substrate 15 side through the connected portion 13. The hole 15c formed in the substrate 15 according to this embodiment is formed in a perfect circle shape that is one size smaller than the insulating member 14 (see Figures 1 and 2).

Here, as shown in FIG. 2, the substrate 15 according to this embodiment has an adhesive layer 15a and a shielding layer 15b.

The adhesive layer 15a is a layer for attaching the bioelectrode 10 to the body surface. The adhesive layer 15a is preferably made of a material that has adhesive strength and is highly biocompatible, such as an acrylic resin. A portion of the adhesive layer 15a (the area near the hole 15c) is in contact with the surface of the insulating member 14.

The shield layer 15b includes a conductive material and is a layer that covers the adhesive layer 15a. The back surface of the shield layer 15b is fixed to the surface of the adhesive layer 15a. That is, the shield layer 15b is provided on the side of the base material 15 opposite to the side in contact with the insulating member 14 (the adhesive layer 15a side). The conductive material is, for example, a material whose surface electrical resistance is 10 ⁷ Ω or less. The conductive material is, for example, a resin material to which an electrolyte such as NaCl or a conductive substance such as conductive carbon has been added. The resin material is not particularly limited, but it is more preferable to use polyurethane, which is flexible, stretchable, and highly biocompatible.

The adhesive layer 15a does not need to be provided over the entire back surface of the shield layer 15b as long as it can maintain the bioelectrode 10 attached to the body surface. In addition, other layers, such as a layer of cushioning material, may be provided between the adhesive layer 15a and the shield layer 15b.

[connector]
As shown in FIGS. 3 and 4 , a connector 20 according to this embodiment includes a connection portion 21 , a housing 22 , and a shielded wire 23 .

(Connection)
The connection part 21 is a part for connecting the connector 20 to the bioelectrode 10. By connecting the connector 20 to the bioelectrode 10, electrical conduction is established. Therefore, an electrical signal output from the bioelectrode 10 is input to the connector 20. The connection part 21 is provided on the back side within the connector 20 (housing 22). In this embodiment, the connection part 21 is disposed in the center of the back side of the connector 20 (housing 22) (see FIG. 4).

The connection portion 21 is made of a material that can conduct electrical signals, such as a metal.

The size and shape of the connection part 21 correspond to the connected part 13 of the bioelectrode 10. The connection part 21 in this embodiment has a concave shape that corresponds to the convex shape of the connected part 13 (a shape equivalent to the concave part of a hook) (see FIG. 3).

(housing)
The housing 22 is a member that constitutes the exterior of the connector 20. The housing 22 contains the connection portion 21 (see FIG. 4).

The size and shape of the housing 22 are not particularly limited as long as it contains the connection portion 21 and is smaller in width than the substrate 15 of the bioelectrode 10. The housing 22 according to this embodiment is cylindrical, contains the connection portion 21, and has a smaller diameter than the substrate 15 (see Figures 3 and 4).

Here, the housing 22 in this embodiment is made of a conductive material.

Specifically, the housing 22 has an outer wall 22a. The outer wall 22a is made of a conductive material. An inner portion 22b of the housing 22 (a portion between the outer wall 22a and the connection portion 21) is made of an insulating material. The insulating material is, for example, polyvinyl chloride resin or acrylic resin .

(Shielded wire)
The shielded wire 23 transmits the received electrical signal to an external device via the connection portion 21 of the connector 20. One end of the shielded wire 23 is connected to the connection portion 21 inside the housing 22. The other end of the shielded wire 23 is connected to an external device (not shown).

==Connecting the bioelectrode and connector==
5, the bioelectrode 10 is attached to the body surface BS by the adhesive layer 15a of the base material 15. The connector 20 is connected to the bioelectrode 10 by attaching the connection part 21 to the connection part 13 of the bioelectrode 10. In this state, the medical device 1 can transmit an electrical signal received by the bioelectrode 10 to an external device via the connector 20.

As shown in FIG. 6, when the bioelectrode 10 and the connector 20 are connected, the shield layer 15b of the substrate 15 comes into contact with the housing 22 (specifically, the outer wall 22a). In other words, the bioelectrode 10 attached to the body surface BS is covered with a member containing a conductive material. Therefore, the bioelectrode 10 is less susceptible to the effects of static electricity from the outside.

Summary of the First Embodiment
As is clear from the above, the medical device 1 according to the present embodiment includes a bioelectrode 10 that is attached to the body surface BS of a living body and receives an electrical signal corresponding to bioinformation, and a connector 20 that transmits the electrical signal received by the bioelectrode 10 to an external device. The bioelectrode 10 includes an electrode element 11, a connected portion 13 that is connected to the electrode element 11 and connects the bioelectrode 10 to the connector 20, an insulating member 14 that covers the electrode element 11 and has a hole 14a through which the connected portion 13 penetrates, and a base material 15 that covers the insulating member 14 and has a hole 15c that is large enough so that the edge portion does not come into contact with the connected portion 13 when the connected portion 13 penetrates the base material 15, and has a shield layer 15b containing a conductive material on the side opposite to the side that contacts the insulating member 14. The connector 20 includes a connection portion 21 for connecting the connector 20 to the bioelectrode 10, and a housing 22 that contains the connection portion 21 and is made of a conductive material. Furthermore, in the medical device 1, when the bioelectrode 10 and the connector 20 are connected, the shield layer 15b and the housing 22 are in contact with each other.

According to such a medical device 1, when the bioelectrode 10 and the connector 20 are connected, the bioelectrode 10 is covered with a member (shield layer 15b and housing 22) containing a conductive material. Therefore, even if the outer wall 22a of the connector 20 comes into contact with the subject's clothing and static electricity is discharged, the static electricity flows through the outer wall 22a and is less likely to accumulate in the bioelectrode 10. Therefore, when the bioelectrode 10 receives an electrical signal, it is less susceptible to the influence of noise generated by the discharge of static electricity. In other words, according to the medical device 1 of this embodiment, the influence of static electricity on the bioelectrode 10 can be reduced.

Second Embodiment
Next, a medical device according to a second embodiment will be described with reference to Fig. 7 to Fig. 11. In this embodiment, an example will be described in which a shielding member is provided to cover the connector when the bioelectrode and the connector are connected. Detailed description of the same configuration as the first embodiment will be omitted.

Figure 7 is a view of the connector 30 from the front side (described later). Figure 8 is a cross-sectional view taken along the line D-D' of the connector 30 shown in Figure 7. Figure 9 is a perspective view of the shielding member 40. Figure 10 is a perspective view showing the connected state of the bioelectrode 10 and connector 30 that constitute the medical device 2. Figure 11 is a cross-sectional view taken along the line E-E' of the bioelectrode 10 and connector 30 shown in Figure 10.

==Medical Equipment==
The medical device 2 according to this embodiment includes a bioelectrode 10 , a connector 30 , and a shield member 40 .

In this embodiment, the side of the bioelectrode 10 that is attached to the living body, the side of the connector 30 that is connected to the bioelectrode 10, and the opening side of the shielding member 40 are referred to as the "back side," and the opposite sides of each are referred to as the "front side." In addition, the direction perpendicular to the front-back direction is referred to as the "width direction."

[Bioelectrode]
The bioelectrode 10 according to this embodiment has the same configuration as that of the first embodiment, and therefore a detailed description thereof will be omitted.

[connector]
As shown in FIGS. 7 and 8 , a connector 30 according to this embodiment includes a connection portion 31 , a housing 32 , and a shielded wire 33 .

(Connection, shielded wire)
The connection portion 31 has a configuration similar to that of the connection portion 21 in the first embodiment, and the shielded wire 33 has a configuration similar to that of the shielded wire 23 in the first embodiment, so detailed description thereof will be omitted.

(housing)
The housing 32 is a member that constitutes the exterior of the connector 30. The housing 32 contains the connection portion 31 (see FIGS. 7 and 8).

The size and shape of the housing 32 are not particularly limited as long as it contains the connection portion 31 and is smaller in width than the substrate 15 of the bioelectrode 10. The housing 32 according to this embodiment contains the connection portion 31 and is cylindrical with a smaller diameter than the substrate 15 (see Figures 7 and 8).

The housing 32 in this embodiment is made of an insulating material.

[Shielding material]
The shield member 40 includes a conductive material and is a member for covering the connector 30 when the bioelectrode 10 and the connector 30 are connected to each other. One end of the shield member 40 is open. As shown in FIG. 9 , the shield member 40 according to the present embodiment includes a frame body 41 and a notch 42.

(Frame)
The frame 41 is a member that constitutes the exterior of the shielding member 40. The frame 41 is made of a conductive material. The frame 41 according to the present embodiment is in the shape of a lid having a hollow portion capable of containing the connector 30 (see FIG. 9 ).

The size and shape of the frame 41 are not particularly limited as long as it can contain the connector 30 and is smaller in width than the base material 15 of the bioelectrode 10. The frame 41 according to this embodiment is cylindrical and can contain the connector 30 (i.e., has a larger diameter than the connector 30) and has a smaller diameter than the base material 15 (see Figures 10 and 11).

(Notch)
The notch 42 is a portion for allowing the shield wire 33 to escape when the connector 30 is covered with the shield member 40. The notch 42 is formed in a part of the housing 41. The shape of the notch 42 is not particularly limited, but it is preferable that the size of the notch 42 is small. In this embodiment, the notch 42 is formed in a semicircular shape from the end of the side surface of the housing 41 (the end on the opening side) (see FIG. 9). Note that the notch 42 is not an essential component of the shield member 40.

==Connecting the bioelectrode and connector==
10, the bioelectrode 10 is attached to the body surface BS by the adhesive layer 15a of the base material 15. The connector 30 is connected to the bioelectrode 10 by attaching the connection part 31 to the connection part 13 of the bioelectrode 10. In this state, the medical device 2 can transmit an electrical signal received by the bioelectrode 10 to an external device via the connector 30. In addition, in a state in which the bioelectrode 10 and the connector 30 are connected, the shielding member 40 is attached so as to cover the connector 30.

As shown in FIG. 11, when the bioelectrode 10 and the connector 30 are connected, the shield layer 15b of the substrate 15 comes into contact with the shield member 40 (specifically, the frame 41). In other words, the bioelectrode 10 attached to the body surface BS is covered with a member containing a conductive material. Therefore, the bioelectrode 10 is less susceptible to the effects of static electricity from the outside.

Summary of the Second Embodiment
As is clear from the above, the medical device 2 according to the present embodiment includes a bioelectrode 10 that is attached to the body surface BS of a living body and receives an electrical signal corresponding to bioinformation, and a connector 30 that transmits the electrical signal received by the bioelectrode 10 to an external device. The bioelectrode 10 includes an electrode element 11, a connected portion 13 that is connected to the electrode element 11 and connects the bioelectrode 10 to the connector 30, an insulating member 14 that covers the electrode element 11 and has a hole 14a through which the connected portion 13 penetrates, and a base material 15 that covers the insulating member 14 and has a hole 15c that is large enough so that the edge portion does not come into contact with the connected portion 13 when the connected portion 13 penetrates the base material 15, and has a shield layer 15b containing a conductive material on the side opposite to the side that contacts the insulating member 14. The connector 30 includes a connection portion 31 for connecting the connector 30 to the bioelectrode 10. In addition, the medical device 2 is formed of a conductive material and further includes a shielding member 40 for covering the connector 30 when the bioelectrode 10 and the connector 30 are connected, and when the bioelectrode 10 and the connector 30 are connected, the shielding layer 15b and the shielding member 40 are in contact with each other.

According to such a medical device 2, when the bioelectrode 10 and the connector 30 are connected, the connector 30 is covered with the shielding member 40, so that the bioelectrode 10 is covered with a member containing a conductive material (the shielding layer 15b and the frame body 41). Therefore, even if the shielding member 40 comes into contact with the subject's clothes and static electricity is discharged, the static electricity flows through the shielding member 40 and is less likely to accumulate in the bioelectrode 10. Therefore, when the bioelectrode 10 receives an electrical signal, it is less susceptible to the influence of noise generated by the discharge of static electricity. In addition, by using the shielding member 40, a connector that has been used conventionally (a connector whose housing is not made of a conductive material) can be used as is. In other words, according to the medical device 2 of this embodiment, the influence of static electricity on the bioelectrode 10 can be reduced.

In this embodiment, the shielding member 40 is an example of a lid-like member having a hollow portion capable of containing the connector 30. On the other hand, the shielding member 40 may be a film-like member that is attached to the outer peripheral surface of the connection portion 31 of the connector 30. The film-like member is a film or sheet that includes a conductive material.

In addition, it is also possible to use the connector 20 described in the first embodiment instead of the connector 30. In this case, the housing 22 and the shielding member 40 each come into contact with the shielding layer 15b of the substrate 15. Therefore, the bioelectrode 10 is less susceptible to the effects of static electricity from the outside.

That is, the medical device 2 according to the present embodiment may have a bioelectrode 10 that is attached to the body surface BS of a living body and receives an electrical signal corresponding to bioinformation, and a connector 20 that transmits the electrical signal received by the bioelectrode 10 to an external device. The bioelectrode 10 includes an electrode element 11, a connected portion 13 that is connected to the electrode element 11 and connects the bioelectrode 10 to the connector 20, an insulating member 14 that covers the electrode element 11 and has a hole 14a through which the connected portion 13 penetrates, and a base material 15 that covers the insulating member 14 and has a hole 15c that is large enough that the edge portion does not come into contact with the connected portion 13 when the connected portion 13 penetrates, and has a shield layer 15b containing a conductive material on the side opposite to the side that contacts the insulating member 14. The connector 20 includes a connection portion 21 for connecting the connector 20 to the bioelectrode 10, and a housing 22 that contains the connection portion 21 and is formed of a conductive material. The medical device 2 is also made of a conductive material and further includes a shielding member 40 for covering the connector 20 when the bioelectrode 10 and the connector 20 are connected, and when the bioelectrode 10 and the connector 20 are connected, the housing 22 and the shielding member 40 each come into contact with the shielding layer 15b.

Third Embodiment
Next, a medical sheet according to a third embodiment will be described with reference to Fig. 12 to Fig. 17. In this embodiment, a medical sheet for covering a medical instrument attached to a living body will be described. Detailed description of the same configuration as the first embodiment will be omitted.

Figure 12 is a view of the bioelectrode 50 from the front side (described later). Figure 13 is an F-F' cross-sectional view of the bioelectrode 50 shown in Figure 12. Figure 14 is a view of the medical sheet 100 from the front side (described later). Figure 15 is a G-G' cross-sectional view of the medical sheet shown in Figure 14. Figure 16 is a perspective view showing a state in which the medical device 3 is covered with the medical sheet 100. Figure 17 is an H-H' cross-sectional view of the bioelectrode 50, connector 30, and medical sheet 100 shown in Figure 16.

==Medical Equipment==
The medical device 3 according to this embodiment has a bioelectrode 50 and a connector 30. In this embodiment, the side of the bioelectrode 50 that is attached to a living body, the side of the connector 30 that is connected to the bioelectrode 50, and the side of the medical sheet 100 that covers the medical device 3 are referred to as the "back side", and the opposite sides are referred to as the "front side". In addition, the direction perpendicular to the front-back direction is referred to as the "width direction".

[Bioelectrode]
As shown in FIGS. 12 and 13 , a bioelectrode 50 according to this embodiment includes an electrode element 51 , a transmission member 52 , a connected portion 53 , and a substrate 54 .

(Electrode element)
The electrode element 51 has the same configuration as the electrode element 11 described in the first embodiment. The electrode element 51 according to this embodiment is disposed so that its front surface is in contact with the rear surface of the substrate 54 (see FIGS. 12 and 13).

(Transmission member)
The transmission member 52 has a similar configuration to the transmission member 12 described in the first embodiment.

(Connected part)
The receptacle 53 has a configuration similar to that of the receptacle 13 described in the first embodiment. In this embodiment, the receptacle 53 protrudes to the front side from a hole 54c formed in the base material 54 (see FIGS. 12 and 13 ).

(Base material)
The substrate 54 is a member for attaching the bioelectrode 50 to the body surface. The substrate 54 is provided so as to cover the electrode element 51 (except for the area where the connected portion 53 is connected). That is, the electrode element 51 and the transmission member 52 are disposed on the back side of the substrate 54. The substrate 54 has a hole 54c formed therein. The hole 54c is a portion through which the connected portion 53 penetrates. The substrate 54 according to this embodiment has a hole 54c formed in the center (see FIGS. 12 and 13). The substrate 54 according to this embodiment is also disposed so as to cover the electrode element 51 (see FIGS. 12 and 13).

The size and shape of the substrate 54 are not particularly limited as long as they are large enough to cover the electrode element 51, but it is preferable that the substrate 54 has a shape without corners (for example, a perfect circle or ellipse) so that it is difficult to peel off from the body surface. The substrate 54 according to this embodiment is disk-shaped with a diameter larger than that of the electrode element 51 and the transmission member 52 (see Figures 12 and 13). The size and shape of the hole 54c formed in the substrate 54 are not particularly limited as long as they are large enough for the connected portion 53 to pass through. The size and shape of the hole 54c according to this embodiment are approximately the same as the narrow diameter portion of the connected portion 53 (see Figure 13).

Here, as shown in FIG. 13, the substrate 54 according to this embodiment has an adhesive layer 54a and a coating layer 54b.

The adhesive layer 54a is the same as the adhesive layer 14a in the first embodiment. On the other hand, the coating layer 54b is made of a nonwoven fabric or a waterproof insulating material, and is a layer that covers the adhesive layer 54a. The back surface of the coating layer 54b is fixed to the surface of the adhesive layer 54a. Note that the adhesive layer 54a does not need to be provided over the entire back surface of the coating layer 54b as long as it can maintain the state in which the bioelectrode 10 is attached to the body surface. In addition, another layer, such as a layer of a cushioning material, may be provided between the adhesive layer 54a and the coating layer 54b.

[connector]
The connector 30 according to this embodiment is similar to that described in the second embodiment.

==Medical Sheets==
The medical sheet 100 is a film-like member for covering the medical device 3 attached to the living body. The size and shape of the medical sheet 100 are not particularly limited as long as it is large enough to cover the medical device 3 (the bioelectrode 50 and the connector 30), but it is preferable that the medical sheet 100 has a shape without corners (for example, a perfect circle or ellipse) so that it is difficult to peel off from the body surface. The medical sheet 100 according to this embodiment is disc-shaped with a diameter larger than the bioelectrode 50 and the connector 30 (see Figs. 14 and 15).

As shown in FIG. 15, the medical sheet 100 according to this embodiment has an adhesive layer 100a and a shielding layer 100b.

The adhesive layer 100a is a layer for attaching the medical sheet 100 to the body surface. The adhesive layer 100a can be made of the same material as the adhesive layer 15a in the first embodiment.

The shield layer 100b contains a conductive material and is a layer that covers the adhesive layer 100a.

The back surface of the shield layer 100b is fixed to the front surface of the adhesive layer 100a. Note that the adhesive layer 100a does not need to be provided over the entire back surface of the shield layer 100b as long as it can maintain the medical sheet 100 attached to the body surface. In addition, another layer, such as a layer of cushioning material, may be provided between the adhesive layer 100a and the shield layer 100b.

The medical sheet 100 according to this embodiment also has a cutout 101 (see FIG. 14). The cutout 101 is a portion for allowing the shield wire 33 to escape when the medical device 3 is covered with the medical sheet 100. The cutout 101 is formed in a portion of the outer periphery of the medical sheet 100. The shape of the cutout 101 is not particularly limited, but it is preferable that the size is small. In this embodiment, the cutout 101 is formed in a semicircular shape in a portion of the outer periphery of the medical sheet 100 (see FIG. 14). Note that the cutout 101 is not an essential component of the medical sheet 100.

==Connecting the bioelectrode and connector==
16 , the bioelectrode 50 is attached to the body surface BS by the adhesive layer 54a of the base material 54. The connector 30 is connected to the bioelectrode 50 by attaching the connection portion 31 to the connection receiving portion 53 of the bioelectrode 50. In this state, the medical device 3 can transmit an electrical signal received by the bioelectrode 50 to an external device via the connector 30. In addition, with the bioelectrode 50 and the connector 30 connected, the medical sheet 100 is attached so as to cover the medical device 3.

As shown in FIG. 17, when the bioelectrode 50 and the connector 30 are connected, the shield layer 100b of the medical sheet 100 covers the entire medical device 3. That is, the bioelectrode 50 attached to the body surface BS is covered by the shield layer 100b containing a conductive material. Therefore, the bioelectrode 50 is less susceptible to the effects of static electricity from the outside.

Summary of the Third Embodiment
As is clear from the above, the medical sheet 100 according to this embodiment is for covering a medical instrument 3 attached to a living body. The medical sheet 100 has an adhesive layer 100a for attaching the medical sheet 100 to the body surface BS of the living body, and a shielding layer 100b that contains a conductive material and covers the adhesive layer 100a.

According to such a medical sheet 100, the medical device 3 attached to the living body can be covered with the shield layer 100b. In this case, the bioelectrode 50 is covered with a member (shield layer 100b) containing a conductive material. Therefore, for example, even if the medical sheet 100 comes into contact with the subject's clothes and static electricity is discharged, the static electricity flows through the medical sheet 100 and is less likely to accumulate in the bioelectrode 50. Therefore, when receiving an electrical signal with the bioelectrode 50, it is less susceptible to the influence of noise generated by the discharge of static electricity. In addition, by using the medical sheet 100, it is possible to use conventionally used bioelectrodes (bielectrodes that do not have a shield layer containing a conductive material) and connectors (connectors whose housings are not formed of a conductive material) as they are. In other words, according to the medical sheet 100 according to this embodiment, the influence of static electricity on the bioelectrode 50 can be reduced.

The medical sheet 100 can also be used for the medical device 1 described in the first embodiment and the medical device 2 described in the second embodiment. In this case, the bioelectrode 10 is less susceptible to the effects of external static electricity.

Fourth Embodiment
A bioelectrode according to a fourth embodiment will be described with reference to Fig. 18 to Fig. 21. In this embodiment, a bioelectrode having a sheet member containing a conductive material will be described. Detailed description of the same configuration as the first embodiment will be omitted.

Figure 18 is a view of the bioelectrode 60 according to this embodiment as seen from the front side (described later). Figure 19 is a cross-sectional view of the bioelectrode 60 shown in Figure 18 taken along line I-I'. Figure 20 is a perspective view showing the bioelectrode 60 and the connector 30 connected together, with the connector 30 covered with a sheet member 65. Figure 21 is a cross-sectional view of the bioelectrode 60 and the connector 30 shown in Figure 20 taken along line J-J'.

==Medical Equipment==
The medical device 4 according to this embodiment has a bioelectrode 60 and a connector 30. In this embodiment, the side of the bioelectrode 60 that is attached to a living body and the side of the connector 30 that is connected to the bioelectrode 60 are referred to as the "back side", and the opposite sides are referred to as the "front side". In addition, the direction perpendicular to the front-back direction is referred to as the "width direction".

[Bioelectrode]
As shown in FIGS. 18 and 19 , a bioelectrode 60 according to this embodiment includes a conductive member 61 , a transmission member 62 , a connected portion 63 , an insulating member 64 , and a sheet member 65 .

(Conductive member)
The conductive member 61 is a member for receiving bioinformation emitted by a living body as an electric signal and guiding the electric signal to the connected portion 63. The conductive member 61 has a predetermined length. The connected portion 63 is provided at one end of the conductive member 61, and the transmission member 62 is provided at the other end (see FIG. 19 ). The conductive member 61 is made of a material capable of conducting an electric signal, such as conductive carbon.

The size and shape of the conductive member 61 are not particularly limited as long as it is smaller in width than the insulating member 64. The conductive member 61 according to this embodiment is smaller in size than the insulating member 64, and has a shape in which circular portions of different sizes are connected by a linear portion with a certain width (see FIG. 18). In addition, a connected portion 63 is provided in the center of one circular portion (the smaller circular portion), and a transmission member 62 is provided on the back side of the center of the other circular portion (the larger circular portion) (see FIGS. 18 and 19).

(Transmission member)
The transmission member 62 transmits an electric signal of bioinformation generated by the living body to the conductive member 61. The transmission member 62 is provided at a position that directly contacts the body surface when the bioelectrode 60 is attached to the body surface of the living body. The transmission member 62 according to the present embodiment is disposed such that its surface contacts the back surface of the conductive member 61 at the other end of the conductive member 61 (the end opposite to the side where the connected portion 63 is provided) (see FIG. 19 ).

The transmission member 62 is composed of, for example, an electrode paste or gel that is mainly made of an electrolyte.

The size and shape of the transmission member 62 are not particularly limited. The transmission member 62 according to the embodiment is disk-shaped with a diameter larger than the other circular portion of the conductive member 61 (see FIG. 18).

(Connected part)
The connected portion 63 is a portion for connecting the bioelectrode 60 to the connector 30. By connecting the bioelectrode 60 to the connector 30, electrical conduction is established. Therefore, the bioelectrode 60 can output the received electrical signal to the connector 30. The connected portion 63 is provided at one end of the conductive member 61 (the end opposite to the side where the transmission member 62 is provided). The connected portion 63 is also composed of a thin-diameter portion having the same diameter as the hole of the conductive member 61, and a head and a base portion having a diameter larger than that of the thin-diameter portion. In this embodiment, the connected portion 63 penetrates a hole formed in the center of one of the true circular portions of the conductive member 61 and a hole 64a formed in the insulating member 64, and protrudes to the front side (see FIG. 19).

The connected portion 63 is made of a material that can conduct electrical signals, such as a metal.

The size and shape of the head of the connected part 63 corresponds to the connecting part 31 of the connector 30. In this embodiment, the head of the connected part 63 has a convex shape (corresponding to the convex part of a hook) (see FIG. 19).

(Insulating material)
The insulating member 64 insulates the conductive member 61 from the sheet member 65. The insulating member 64 is provided between the conductive member 61 and the sheet member 65.

The insulating member 64 is made of an insulating material such as polyvinyl chloride resin or acrylic resin.

The insulating member 64 in this embodiment is arranged so that its back surface is in contact with the surface of the conductive member 61, and a portion of its surface (the area opposite to the side where the hole 64a is formed) is arranged so that it is in contact with the back surface of the sheet member 65 (first shielding region SE1) (see FIG. 19).

The size and shape of the insulating member 64 are not particularly limited as long as it is smaller in width than the sheet member 65 and larger in width than the conductive member 61. The insulating member 64 according to this embodiment is smaller in size than the sheet member 65 and larger in size than the conductive member 61, and has a shape in which circular portions of different sizes are connected by a linear portion with a certain width (see FIG. 18). In addition, a connected portion 63 is provided in the center of one circular portion (the smaller circular portion), and a transmission member 62 is provided on the back side of the center of the other circular portion (the larger circular portion) via the conductive member 61 (see FIGS. 18 and 19).

Here, the insulating member 64 has a hole 64a formed therein. The hole 64a is the portion through which the connected portion 63 passes. In this embodiment, the hole 64a is formed at the end opposite the side on which the transmission member 62 is provided (see FIG. 18). The hole 64a is an example of a "third hole."

(Sheet member)
The sheet member 65 is a film-like member for covering the insulating member 64. The size and shape of the sheet member 65 are not particularly limited as long as it is large enough to cover the insulating member 64, but it is preferable that the sheet member 65 has a shape without corners (for example, a perfect circle or an ellipse) so that it is difficult to peel off from the body surface. The sheet member 65 according to this embodiment is disk-shaped and larger than the insulating member 64 (see FIG. 18).

As shown in FIG. 19, the sheet member 65 according to this embodiment has an adhesive layer 65a and a shielding layer 65b.

The adhesive layer 65a is a layer for attaching the bioelectrode 60 to the body surface. The adhesive layer 65a can be made of the same material as the adhesive layer 15a in the first embodiment.

The shield layer 65b contains a conductive material and is a layer that covers the adhesive layer 65a. The lower surface of the shield layer 65b is fixed to the upper surface of the adhesive layer 65a.

Here, the sheet member 65 has a first shield region SE1 and a second shield region SE2.

The first shield region SE1 is a region that is fixed to the side opposite to the side where the hole 64a of the insulating member 64 is formed (the side opposite to the side where the connected portion 63 is provided). Specifically, the first shield region SE1 is fixed to the surface of the insulating member 64 by an adhesive layer 65a.

The second shield region SE2 is a region for covering the connector 30 when the connector 30 is connected. Specifically, the second shield region SE2 is located on the side where the hole 64a of the insulating member 64 is formed. On the other hand, unlike the first shield region SE1, the second shield region SE2 is not fixed to the insulating member 64 (see FIG. 19).

[connector]
The connector 30 according to this embodiment is similar to that described in the second embodiment.

==Connecting the bioelectrode and connector==
20 , the bioelectrode 60 is attached to the body surface BS by an adhesive layer 65a of a sheet member 65. The connector 30 is connected to the bioelectrode 60 by attaching the connection portion 31 to the connection receiving portion 63 of the bioelectrode 60. In this state, the medical instrument 4 can transmit an electrical signal received by the bioelectrode 60 to an external device via the connector 30. In addition, with the connector 30 connected, the sheet member 65 is attached so as to cover the connector 30.

As shown in FIG. 21, when the bioelectrode 60 and the connector 30 are connected, the second shielding area SE2 of the sheet member 65 covers the connector 30. Also, the first shielding area SE1 of the sheet member 65 covers the transmission member 62. In other words, the bioelectrode 60 attached to the body surface BS is covered by the shielding member 65 that the bioelectrode 60 itself has. Therefore, the bioelectrode 60 is less susceptible to the effects of static electricity from the outside.

Summary of the Fourth Embodiment
As is clear from the above, the bioelectrode 60 according to this embodiment is attached to the body surface BS of a living body and is for receiving an electrical signal from the living body. The bioelectrode 60 includes a conductive member 61 having a predetermined length, a connected portion 63 provided at one end of the conductive member 61 for connecting the bioelectrode 60 to the connector 30, an insulating member 64 having a hole 64a through which the connected portion 63 passes and covering the conductive member 61, and a sheet member 65 containing a conductive material. The sheet member 65 includes a first shield region SE1 fixed to the side opposite to the side where the hole 64a of the insulating member 64 is formed, and a second shield region SE2 for covering the connector 30 when the connector 30 is connected.

With such a bioelectrode 60, when the bioelectrode 60 and the connector 30 are connected, the conductive member 61 and the connector 30 can be covered with a sheet member 65 containing a conductive material. Therefore, even if the sheet member 65 comes into contact with the subject's clothing and static electricity is discharged, the static electricity flows through the sheet member 65 and is less likely to accumulate in the conductive member 61. Therefore, when the bioelectrode 60 receives an electrical signal, it is less susceptible to the effects of noise generated by the discharge of static electricity. In other words, with the bioelectrode 60 according to this embodiment, the effects of static electricity on the bioelectrode 60 can be reduced.

＜Other＞
The above embodiment is presented as an example and does not limit the scope of the invention. The above configurations can be implemented in appropriate combinations, and various omissions, substitutions, and modifications can be made without departing from the gist of the invention. The above embodiment and its modifications are included in the scope of the invention and its equivalents as described in the claims, as well as the scope and gist of the invention.

Reference Signs List 1, 2, 3, 4 Medical device 10, 50, 60 Bioelectrode 11, 51 Electrode element 12, 52, 62 Transmission member 13, 53, 63 Connected portion 14, 64 Insulating member 15, 54 Substrate 15a, 54a, 65a, 100a Adhesive layer 15b, 65b, 100b Shield layer 20, 30 Connector 21, 31 Connection portion 22 Housing 40 Shielding member 61 Conductive member 65 Sheet member 100 Medical sheet

Claims (7)

A medical device having a bioelectrode attached to a body surface of a living body for receiving an electrical signal corresponding to bioinformation, and a connector for transmitting the electrical signal received by the bioelectrode to an external device,
The bioelectrode is
An electrode element;
a connecting portion connected to the electrode element for connecting the bioelectrode to the connector;
an insulating member that covers the electrode element and that has a first hole through which the connected portion passes;
a base material covering the insulating member, the base material having a second hole having a size such that an edge portion of the second hole does not come into contact with the connected portion when the connected portion penetrates the second hole, the base material having a shield layer including a conductive material on an opposite side to the side contacting the insulating member;
Including,
The connector includes:
a connection portion for connecting the connector to the bioelectrode;
a housing that contains the connection portion and is made of a conductive material;
Including,
A medical device in which the shielding layer and the housing are in contact with each other when the bioelectrode and the connector are connected. A medical device having a bioelectrode attached to a body surface of a living body for receiving an electrical signal corresponding to bioinformation, and a connector for transmitting the electrical signal received by the bioelectrode to an external device,
The bioelectrode is
An electrode element;
a connecting portion connected to the electrode element for connecting the bioelectrode to the connector;
an insulating member that covers the electrode element and that has a first hole through which the connected portion passes;
a base material covering the insulating member, the base material having a second hole having a size such that an edge portion of the second hole does not come into contact with the connected portion when the connected portion penetrates the second hole, the base material having a shield layer including a conductive material on an opposite side to the side contacting the insulating member;
Including,
The connector includes:
a connection portion for connecting the connector to the bioelectrode;
The medical device comprises:
The connector further includes a shield member that is formed of a conductive material and that covers the connector when the bioelectrode and the connector are connected to each other.
A medical device in which the shielding layer and the shielding member are in contact with each other when the bioelectrode and the connector are connected. The medical device according to claim 2, characterized in that the shielding member is a lid-shaped member having a hollow portion capable of containing the connector. The medical device according to claim 2, characterized in that the shielding member is a film-like member that is attached to the outer peripheral surface of the connection portion. A medical device having a bioelectrode attached to a body surface of a living body for receiving an electrical signal corresponding to bioinformation, and a connector for transmitting the electrical signal received by the bioelectrode to an external device,
The bioelectrode is
An electrode element;
a connecting portion connected to the electrode element for connecting the bioelectrode to the connector;
an insulating member that covers the electrode element and that has a first hole through which the connected portion passes;
a base material covering the insulating member, the base material having a second hole having a size such that an edge portion of the second hole does not come into contact with the connected portion when the connected portion penetrates the second hole, the base material having a shield layer including a conductive material on an opposite side to the side contacting the insulating member;
Including,
The connector includes:
a connection portion for connecting the connector to the bioelectrode;
a housing that contains the connection portion and is made of a conductive material;
Including,
The medical device comprises:
The connector further includes a shield member that is formed of a conductive material and that covers the connector when the bioelectrode and the connector are connected to each other.
A medical device in which, when the bioelectrode and the connector are connected, the housing and the shielding member each come into contact with the shielding layer. A medical sheet for covering a medical instrument attached to a living body,
an adhesive layer for attaching the medical sheet to a body surface of a living body;
a shield layer including a conductive material and covering the adhesive layer;
A medical sheet having the above structure. A bioelectrode for receiving an electrical signal from a living body, the bioelectrode being attached to a body surface of the living body,
A conductive member having a predetermined length;
a connection portion provided at one end of the conductive member for connecting the bioelectrode to the connector;
an insulating member having a third hole through which the connected portion passes and covering the conductive member;
A sheet member including a conductive material;
having
The sheet member is
a first shielding region fixed to a side of the insulating member opposite to a side on which the third hole is formed;
a second shielding region for covering the connector when the connector is connected;
A bioelectrode having

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