Defibrillation pad, defibrillator, and defibrillation pad manufacturing method

Abstract

To provide a defibrillation pad, a defibrillator, and a defibrillation pad manufacturing method that inhibit the structure from becoming complicated.SOLUTION: A defibrillation pad 100 includes a sheet-like base material 10, an electrode layer 20 formed on a first surface 10a of the base material 10, a conductive gel layer 30 formed on the electrode layer 20, and a terminal 40 attached to the base material 10, to which a lead wire 130 is connected. The terminal 40 includes a protrusion 42 penetrating through the thickness of the base material 10 and a flange 41 spreading from one end of the protrusion 42 in a surface direction of the base material 10. The flange 41 is connected to the electrode layer 20 so as to overlap at least the electrode layer 20 on a first surface 10a side of the base material 10. The protrusion 42 is connected to the lead wire 130 on a second surface 10b side which is the side opposite to the first surface 10a side of the base material 10.SELECTED DRAWING: Figure 6

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to defibrillation pads, defibrillators, and methods of manufacturing defibrillation pads. [Background technology]

[0002] External defibrillators have been widely used as devices that deliver electric shocks to patients suffering from ventricular fibrillation and other specific arrhythmias (ventricular tachycardia, atrial fibrillation, atrial flutter, and supraventricular tachycardia) to restore cardiac function.

[0003] An external defibrillator delivers an electric shock to a patient via a pair of defibrillation paddles that are pressed against the patient's chest by a medical professional or via a pair of defibrillation pads that are attached to the patient's chest.

[0004] Each defibrillation pad in the pair includes a plate-shaped substrate, a conductive gel layer formed on one surface of the substrate, electrodes, and lead wires. The lead wires are detachably connected to the external defibrillator body, and voltage from the external defibrillator body is applied to the conductive gel layer via the lead wires and the electrodes. As a result, defibrillation voltage is applied to the patient from the conductive gel layer attached to the patient's chest.

[0005] As such a defibrillation pad, for example, a disposable type defibrillation pad as described in Patent Document 1 is known. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Japanese Patent Application Laid-Open No. 2010-063771 Summary of the Invention [Problem to be solved by the invention]

[0007] However, there is a demand for reducing manufacturing costs as much as possible for disposable defibrillation pads, and therefore, defibrillation pads often have a simpler configuration than, for example, defibrillation paddles.

[0008] The present disclosure has been made in consideration of the above points, and provides a defibrillation pad, a defibrillator, and a method for manufacturing a defibrillation pad, which are configured in a less complicated manner. [Means for solving the problem]

[0009] One aspect of the defibrillation pad of the present disclosure comprises: A sheet-like substrate; an electrode layer formed on a first surface of the substrate; a conductive gel layer formed on the electrode layer; a terminal attached to the substrate and to which a lead wire is connected; and The terminal is a projection penetrating the thickness of the base material and a flange extending from one end of the projection in a surface direction of the base material, The flange is connected to the electrode layer so as to overlap at least the electrode layer on the first surface side of the base material, and the protrusion is connected to the lead wire on the second surface side of the base material, which is opposite to the first surface.

[0010] One aspect of the defibrillator of the present disclosure comprises: a pair of electrode pads each having a sheet-like substrate, an electrode layer formed on a first surface of the substrate, a conductive gel layer formed on the electrode layer, and a terminal attached to the substrate and to which a lead wire is connected; The lead wire; a defibrillator body connected to the pair of electrode pads via the lead wires; 1. A defibrillator having: The terminal is a projection penetrating the thickness of the base material and a flange extending from one end of the projection in a surface direction of the base material, The flange is connected to the electrode layer so as to overlap at least the electrode layer on the first surface side of the base material, and the protrusion is connected to the lead wire on the second surface side of the base material, which is opposite to the first surface.

[0011] One aspect of the method of manufacturing a defibrillation pad of the present disclosure comprises: forming an electrode layer on a first surface of a sheet-like substrate; a step of attaching a terminal having a protrusion and a flange to the base material such that the protrusion penetrates the thickness of the base material and the flange overlaps at least the electrode layer on the first surface side of the base material; covering the flange with an insulating material; forming a conductive gel on the electrode layer; Attaching a release sheet to the conductive gel; Includes: [Effects of the Invention]

[0012] According to the present disclosure, a defibrillation pad, a defibrillator, and a method for manufacturing a defibrillation pad are provided, which are configured in a less complicated manner. [Brief explanation of the drawings]

[0013] [Figure 1] FIG. 1 is a diagram showing a state in which a defibrillation pad according to an embodiment is in use. [Figure 2] FIG. 1 is a partially exploded perspective view illustrating the configuration of an electrode pad; [Figure 3] 1 is a diagram illustrating a method for manufacturing a defibrillation pad according to an embodiment of the present invention; [Figure 4] A perspective view showing the configuration of the terminal [Figure 5] FIG. 10 is a partially exploded perspective view illustrating the connection state of the terminals; [Figure 6] Cross section of the electrode pad cut along the YZ plane including the terminal DETAILED DESCRIPTION OF THE INVENTION

[0014] Hereinafter, embodiments of the present disclosure will be described in detail with reference to the drawings.

[0015] FIG. 1 shows a defibrillation pad 100 according to an embodiment in use. The defibrillation pad 100 includes a pair of electrode pads 110 and 120, a lead wire 130, and a connector 140. The pair of electrode pads 110 and 120 are attached to predetermined positions on the chest of a patient 1. Of the electrode pads 110 and 120, the electrode pad 110 is the cathode, and the electrode pad 120 is the anode. The connector 140 is connected to a defibrillator main body 200. This applies a voltage to the electrode pads 110 and 120 from the defibrillator main body 200, causing a current corresponding to that voltage to flow through the heart, thereby achieving defibrillation. Note that if the defibrillator main body 200 has a pacing function in addition to a defibrillation function, pacing therapy can also be performed via the defibrillation pads 110 and 120.

[0016] Here, the defibrillator 300 is made up of the defibrillation pad 100 and the defibrillator main body 200. In other words, the defibrillator 300 has a pair of electrode pads 110, 120, a lead wire 130, and the defibrillator main body 200 connected to the pair of electrode pads 110, 120 via the lead wire 130.

[0017] Fig. 2 is a partially exploded perspective view illustrating the configuration of the electrode pads 110 and 120. In order to make the configuration easier to see, Fig. 2 shows the configuration of one of the pair of electrode pads 110 and 120 in detail, and the configuration of the other electrode pad is partially omitted. The electrode pads 110 and 120 have almost the same configuration.

[0018] The electrode pads 110, 120 have a sheet-like substrate 10, an electrode layer 20 formed on the first surface 10a of the substrate 10, a conductive gel layer 30 formed on the electrode layer 20, and a terminal 40 attached to the substrate 10 and to which a lead wire 130 is connected.

[0019] Furthermore, the electrode pads 110 and 120 are provided with an insulating sheet 50 that covers the terminals 40. In this specification, the term "sheet" may be read as "film."

[0020] A release sheet 60 is attached to the conductive gel layer 30. Note that in Fig. 2, the release sheet 60 of the electrode pad 120 is omitted.

[0021] Here, the substrate 10 is an insulating sheet. The electrode layer 20 is conductive and contains a conductive material. The electrode layer 20 in the cathode electrode pad 110 and the electrode layer 20 in the anode electrode pad 120 may both contain the same material. For example, the electrode layer 20 in the cathode electrode pad 110 and the electrode layer 20 in the anode electrode pad 120 may contain silver and silver chloride, or silver, silver chloride, and carbon. Alternatively, the electrode layer 20 in the cathode electrode pad 110 and the electrode layer 20 in the anode electrode pad 120 may be composed of different materials. For example, the electrode layer 20 in the cathode electrode pad 110 may contain silver and silver chloride, or silver, silver chloride, and carbon, while the electrode layer 20 in the anode electrode pad 120 may not contain silver chloride (for example, silver, or silver and carbon). The conductive gel layer 30 is an electrolyte and contains water, sodium chloride, an acrylic polymer, etc. The terminal 40 is made of a conductive material.

[0022] 3 is a diagram illustrating a method for manufacturing the defibrillation pad 100 of this embodiment. In the method for manufacturing the defibrillation pad 100 described below, the electrode layer 20 of the cathode electrode pad 110 and the electrode layer 20 of the anode electrode pad 120 are both assumed to contain silver and silver chloride. Of course, the present invention is not limited to this, and the cathode electrode pad 110 and the anode electrode pad 120 may be made of different materials and manufactured on separate manufacturing lines.

[0023] First, as shown in FIG. 3A, an insulating sheet-like substrate 10 is prepared. Next, as shown in FIG. 3B, an electrode layer 20 is formed by screen printing an ink containing silver and silver chloride on the substrate 10. Specifically, the electrode layer 20 is formed by screen printing an ink composed of powdered silver, silver chloride, a solvent, and the like. Note that the electrode layer 20 may be formed by other printing methods, not limited to screen printing. For example, the electrode layer 20 may be formed by printing the ink using intaglio printing, letterpress printing, lithographic printing, or the like.

[0024] Here, the thickness of the printed film, i.e., the thickness of the electrode layer 20, is, for example, 5 to 10 μm. The thickness of the electrode layer 20 is preferably 3 μm or more to ensure the electrical characteristics required for a defibrillator, and more preferably 5 μm to ensure sufficient electrical characteristics. Furthermore, when an X-ray examination or the like is performed on a patient 1 with the electrode pads 110 and 120 attached, it is preferable that the electrode pads 110 and 120 have high X-ray transparency. Therefore, the thickness of the electrode layer 20 is preferably 10 μm or less, and more preferably 8 μm or less to ensure sufficient X-ray transparency. Note that while FIG. 3B shows an example in which ten electrode layers 20 are printed on one substrate 10, the present invention is not limited to this, and for example, one electrode layer 20 may be printed on one substrate 10.

[0025] 3C and 3D, the substrate 10 is cut into a predetermined shape. In addition, holes 70 are drilled through the thickness of the substrate 10 and the electrode layer 20 at the bottom of the substrate 10 and the electrode layer 20. The cutting step into a predetermined shape and the drilling step of the holes 70 may be performed simultaneously as shown in FIG. 3C, or the cutting step may be performed after the drilling step, or the drilling step may be performed after the cutting step.

[0026] 3E, terminals 40 are attached to holes 70. Furthermore, lead wires 130 are attached to terminals 40. The attachment of terminals 40 to holes 70 and the attachment of lead wires 130 to terminals 40 will be described in detail later.

[0027] Next, as shown in FIG. 3F , the terminals 40 are covered with an insulating sheet 50. Specifically, an adhesive is applied to the surface of the sheet 50 facing the electrode layer 20, and the sheet 50 is adhered to the electrode layer 20. The sheet 50 may be adhered directly to the terminals 40, or may be adhered to the electrode layer 20 printed around the terminals 40, or may be adhered to the substrate 10 located further outside the electrode layer 20. Furthermore, it is sufficient that the sheet 50 is able to cover the terminals 40, and the covering method (adhesion, etc.), covering position of the sheet 50, shape of the sheet 50 (covering shape), etc. may be selected as appropriate.

[0028] 3G, a conductive gel layer 30 is formed on the surface side of the electrode layer 20. As a result, the electrode layer 20 and the conductive gel layer 30 are electrically connected to each other.

[0029] Here, the sheet 50 is sized to completely cover at least the side of the terminal 40 facing the patient 1. By providing the insulating sheet 50 to cover the terminal 40 in this manner, a direct current flow from the terminal 40 to the body surface of the patient 1 without passing through the electrode layer 20 is prevented. As a result, electrical bias at the terminal 40 is prevented, and uniform electricity is supplied to the patient 1 via the electrode layer 20. This also prevents burns to the patient 1's skin facing the terminal 40 when a high voltage is applied. Furthermore, the sheet 50 is preferably sized so as not to cover as much of the electrode layer 20 as possible other than the terminal 40. If the sheet 50 is too large, for example, when the sheet 50 is provided between the terminal 40 (electrode layer 20) and the conductive gel layer 30, the area of ​​electrical connection between the electrode layer 20 and the conductive gel layer 30 becomes small, which is an inconvenience.

[0030] Next, as shown in FIG. 3H, a release sheet 60 is attached to the conductive gel layer 30.

[0031] The electrode pads 110, 120 thus prepared are shipped sealed in a package such as an aluminum bag. When in use, the user removes the electrode pads 110, 120 from the package, peels off the release sheet 60, and attaches the electrode pads 110, 120 to the chest of the patient 1 as shown in Figure 1, and then operates the defibrillator main unit 200.

[0032] 4 is a perspective view showing the configuration of terminal 40. Terminal 40 is preferably made of a material with relatively high conductivity, such as a highly conductive metal such as copper or a compound thereof. Terminal 40 has a flange 41 and a protrusion 42.

[0033] Fig. 5 is a partially exploded perspective view illustrating the connection state of the terminal 40. Fig. 6 is a cross-sectional view (a cross-sectional view of the electrode pads 110, 120 cut along the YZ plane including the terminal 40) illustrating the connection state of the terminal 40 and the configuration of the electrode pads 110, 120 near the terminal 40.

[0034] The terminal 40 is inserted into a hole 70 formed in the base material 10 and the electrode layer 20 from the direction of the electrode layer 20. As a result, a flange 41 of the terminal 40 abuts against the surface of the electrode layer 20. Furthermore, a protrusion 42 of the terminal 40 protrudes from the surface (second surface 10b) of the base material 10 opposite to the surface (first surface 10a) on which the electrode layer 20 is formed. A ring terminal 131 provided at the tip of the lead wire 130 is inserted into the protrusion 42 of the terminal 40 protruding from the base material 10. As a result, the lead wire 130 and the terminal 40 are electrically connected.

[0035] Next, the protrusion 42 of the terminal 40 and the ring terminal 131 of the lead wire 130 are covered with the sheet 80. This prevents mechanical connection failures and the like caused by the ring terminal 131 coming off the protrusion 42. Furthermore, it is more preferable if the sheet 80 is an insulating sheet, since it can electrically protect the connection between the protrusion 42 and the ring terminal 131. Note that, to prevent mechanical connection failures and the like caused by the ring terminal 131 coming off the protrusion 42, the tip of the protrusion 42 (the left end in FIG. 6) may be slightly bulged (thicker than the other portions) as shown in FIG. 6. Furthermore, to prevent mechanical connection failures and the like caused by the ring terminal 131 coming off the protrusion 42, the tip of the protrusion 42 may be crushed after the ring terminal 131 is inserted into the protrusion 42, or a cover member (not shown) may be attached to the tip of the protrusion 42.

[0036] 6, on the flange 41 side, the electrode layer 20 is formed on the substrate 10, and the flange 41 is connected to a part of the electrode layer 20. Note that almost the entire surface of the flange 41 that faces the electrode layer 20 is in contact with the electrode layer 20. Furthermore, an insulating sheet 50 is attached so as to cover the flange 41. Furthermore, the surface of the electrode layer 20 outside the area where the insulating sheet 50 is attached is in contact with the conductive gel layer 30, and the electrode layer 20 and the conductive gel layer 30 are electrically connected.

[0037] As described above, according to this embodiment, the defibrillation pad 100 includes a sheet-like substrate 10, an electrode layer 20 formed on a first surface 10a of the substrate 10, a conductive gel layer 30 formed on the electrode layer 20, and a terminal 40 attached to the substrate 10 and connected to a lead wire 130. Furthermore, in the defibrillation pad 100, the terminal 40 includes a protrusion 42 penetrating the thickness of the substrate 10 and a flange 41 extending from one end of the protrusion 42 in the planar direction of the substrate 10, the flange 41 being connected to the electrode layer 20 on the first surface side of the substrate 10 so as to overlap at least the electrode layer 20, and the protrusion 42 being connected to the lead wire 130 on the second surface 10b side of the substrate 10 opposite the first surface 10a.

[0038] Thus, because the terminal 40 has the protrusion 42 that penetrates the thickness of the base material 10, the lead wire 130 is less likely to come loose in the -Y direction. This improves mechanical strength. Furthermore, because the flange 41 increases the contact area between the terminal 40 and the electrode layer 20, the reliability of the electrical connection between the terminal 40 and the electrode layer 20 improves. Thus, the configuration of this embodiment makes it possible to realize a defibrillation pad with improved electrical characteristics and mechanical strength, while preventing the configuration from becoming too complicated.

[0039] Furthermore, according to this embodiment, the portion corresponding to the flange 41 is covered with an insulating member (sheet 50). This prevents current from flowing from the terminal 40 to the body surface of the patient 1 only through the conductive gel layer 30 (electrolyte) without passing through the electrode layer 20. In other words, electrical bias during defibrillation is suppressed, and uniform electricity is supplied to the patient 1 through the electrode layer 20 and the conductive gel layer 30. As a result, for example, burns caused by a large current flowing through the skin of the patient 1 facing the terminal 40 can be prevented. Furthermore, for example, when an external force is applied to the terminal 40 in the −Z direction, the sheet 50 prevents the flange 41 from moving in the −Z direction and separating from the electrode layer 20, thereby further improving the reliability of the electrical connection.

[0040] Furthermore, according to this embodiment, the electrode layer 20 is configured to contain silver (Ag) and silver chloride (AgCl), thereby realizing a defibrillation pad 100 with good defibrillation recovery properties.

[0041] Here, defibrillation recovery refers to the time required between one defibrillation and the next. High defibrillation recovery refers to a short time required between one defibrillation and the next. To improve defibrillation recovery, it is necessary to make it difficult for electric charge to accumulate between electrode pads 110 and 120 when a defibrillation voltage is applied.

[0042] In this embodiment, the electrode layer 20 of the electrode pad 110 is configured to contain silver (Ag) and silver chloride (AgCl), thereby reducing the energy required to transfer electrons at the interface between the electrode layer 20 and the conductive gel layer 30. As a result, less charge remains at the interface between the electrode layer 20 and the conductive gel layer 30, making it difficult for a potential to be generated at the interface between the electrode layer 20 and the conductive gel layer 30. Therefore, charge is less likely to accumulate in the electrode pads 110, 120, making it possible to realize a defibrillation pad 100 with good defibrillation recovery properties.

[0043] Furthermore, when pacing is performed using the defibrillator pad 100, the defibrillator 300 passes a direct current in one direction. In this case, the amount of silver (Ag) in the defibrillator pad 100 (electrode layer 20), which is the source of the free electrons that can be extracted to pass the current during operation of the defibrillator 300, has a significant effect on the pacing function. In other words, from the perspective of pacing, the greater the amount of reactive silver (= the amount of electrons that can be extracted), the longer the pacing period, which is advantageous.

[0044] The defibrillator 300 defibrillates the patient 1 depending on the patient's condition during pacing. If silver chloride (AgCl) is not present, as described above, charges accumulate at the interface between the electrode layer 20 and the conductive gel layer 30, which is detrimental to defibrillation recovery. In this embodiment, taking these factors into consideration, the electrode layer 20 of the cathode electrode pad 110 contains silver (Ag) and silver chloride (AgCl). In this embodiment, the silver chloride content is 5 to 10%. This configuration can enhance defibrillation recovery while suppressing degradation of the pacing function.

[0045] The above-described embodiments are merely examples of specific embodiments of the present invention, and the technical scope of the present invention should not be construed as being limited by these embodiments. In other words, the present invention can be embodied in various forms without departing from the gist or main characteristics thereof.

[0046] In the above embodiment, the electrode layer 20 of the cathode electrode pad 110 is described as containing silver (Ag) and silver chloride (AgCl), but the electrode layer 20 may be made of, for example, silver only, or may be made of other materials. Also, in the above embodiment, the electrode layer 20 is formed by printing, but this is not limiting and the electrode layer 20 may be formed using other electrode manufacturing techniques, such as a thin film process.

[0047] In the above embodiment, the flange 41 is covered with the insulating sheet 50, but this is not limiting. For example, the flange 41 may be covered with a simple protective sheet that may or may not be insulating, and an insulating paint or the like may be applied to the protective sheet, or an insulating layer may be formed by applying an insulating paint or the like directly to the flange 41. In short, it is sufficient to cover the portion corresponding to the flange 41 with an insulating member.

[0048] In the above embodiment, the flange 41 of the terminal 40 is disposed between the electrode layer 20 and the conductive gel layer 30, but the flange 41 of the terminal 40 may be disposed between the substrate 10 and the electrode layer 20. In this case, the electrode layer 20 may be formed after the terminal 40 is attached to the substrate 41. [Industrial Applicability]

[0049] The present disclosure is widely applicable to defibrillation pads that are attached to the body surface of a patient, defibrillators, and methods for manufacturing defibrillation pads. [Explanation of symbols]

[0050] 1 patient 10 Base material 10a First Side 10b Second Side 20 electrode layer 30 Conductive gel layer 40 terminals 41 flange 42 Protrusion 50, 80 Insulating sheet 60 Peel-off sheet 70 holes 100 defibrillator pads 110, 120 electrode pads 130 lead wire 131 Ring terminal 140 Connector 200 Defibrillator body 300 Defibrillator

Claims

1. A sheet-like substrate; an electrode layer formed on a first surface of the substrate; a conductive gel layer formed on the electrode layer; a terminal attached to the substrate and to which a lead wire is connected; and The terminal is a projection penetrating the thickness of the base material and a flange extending from one end of the projection in a surface direction of the base material, the flange is connected to the electrode layer on the first surface side of the base material so as to overlap at least the electrode layer, and the protrusion is connected to the lead wire on the second surface side of the base material, which is opposite to the first surface. Defibrillation pads.

2. The portion corresponding to the flange is covered with an insulating member.

10. The defibrillation pad of claim 1.

3. The flange is disposed between the electrode layer and the conductive gel layer.

2. The defibrillation pad of claim 1.

4. The lead wire has a ring terminal, and the ring terminal is fitted into the protrusion of the terminal, thereby being electrically connected to the terminal.

10. The defibrillation pad of claim 1.

5. The electrode layer comprises silver and silver chloride.

10. The defibrillation pad of claim 1.

6. a pair of electrode pads, each of which has a sheet-like substrate, an electrode layer formed on a first surface of the substrate, a conductive gel layer formed on the electrode layer, and a terminal attached to the substrate and to which a lead wire is connected; The lead wire; a defibrillator body connected to the pair of electrode pads via the lead wires; 1. A defibrillator having: The terminal is a projection penetrating the thickness of the base material and a flange extending from one end of the projection in a surface direction of the base material, the flange is connected to the electrode layer on the first surface side of the base material so as to overlap at least the electrode layer, and the protrusion is connected to the lead wire on the second surface side of the base material, which is opposite to the first surface. Defibrillator.

7. the defibrillator main body has a defibrillation function and a pacing function, the electrode layer of the cathode side electrode pad of the pair of electrode pads contains silver and silver chloride; 7. The defibrillator of claim 6.

8. forming an electrode layer on a first surface of the sheet-like substrate; a step of attaching a terminal having a protrusion and a flange to the base material such that the protrusion penetrates the thickness of the base material and the flange overlaps at least the electrode layer on the first surface side of the base material; covering the flange with an insulating material; forming a conductive gel on the electrode layer; Attaching a release sheet to the conductive gel; A method for manufacturing a defibrillation pad, comprising:

9. a step of fitting a ring terminal provided at one end of the lead wire into the protrusion protruding from the base on a second surface side of the base opposite to the first surface; covering the protrusion and the ring terminal with an insulating material; further comprising:

9. A method for manufacturing a defibrillation pad according to claim 8.

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