JP2007209432A - Biomedical electrode unit package and method for examining and determining quality of the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To determine the quality of an electrode member, such as an electrode or the like, without opening a package, and to facilitate handling by preventing tangling of two electrical leads when taking out the electrode from a sealed package. <P>SOLUTION: A biomedical electrode unit contains first and second electrode members 20a and 20b and a parallel line section 29. The parallel line section is formed by arranging a first electrical lead 22a connected to the first electrode member 20a and a second electrical lead 22b connected to the second electrode member 20b in parallel and by adhering coating members coating the electrical leads integrally. The other end of the first electrical lead 22a is connected to a second auxiliary electrical lead 25b, a conductive material 27b and the second electrode member 20b via a connector 24 and the other end of the second electrical lead 22b is connected to a first auxiliary electrical lead 25a, a conductive material 27a and the first electrode member 20a via the connector 24 to form a closed circuit in which the first and second electrical leads 22a and 22b are connected in series. The parallel line section 29 is coiled. The biomedical electrode unit is sealed within a sealing package member in such a condition. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a packaging body in which a biological electrode applied to an electrode for a defibrillator or the like is hermetically packaged as a biological electrode unit. Periodically, it is possible to easily and easily perform the quality determination test of the electrode in the packaged state, and to appropriately and quickly determine the quality of the electrode in the packaged state, and to determine the quality of the living body electrode unit package It is about the method.

  Conventionally, as a medical electronic device, for example, a medical electrode is sealed and packaged in order to store the electrode in a stable state. Moreover, the medical electrode preserve | saved as a packaged body sealed in this way is also test | inspected regularly for the electrical use possibility of an electrode, without opening in a preservation | save state.

  Therefore, for example, Patent Document 1 discloses a seal-wrapped medical electrode system used for an electronic medical device that can periodically check the electrical usability of an electrode without opening it. The indicated system is known. In this cited document 1, (1) -a- flat and thin non-conductive base layer, -b- conductive semi-liquid gel layer placed on the side of the base layer and contacting the patient, -c- the gel A first disposable electrode disposed on the patient's body and connected to the electro-medical device comprising conductive connection means communicatively connected to the layer, and (2) -a- a flat and thin non-conductive base layer; b- a conductive semi-liquid gel layer in contact with the patient disposed on the base layer side, -c- an electron disposed on the patient's body comprising conductive connection means connected to the gel layer in a conductive manner. A second disposable electrode connected to the medical device; and (3) a thin, usually flat and flexible, constructed and arranged to form an internal space to surround the first and second electrodes; A package made of a completely non-gas-permeable polymer material; and (4) the first and second electrodes. A connecting means extends through the package to the outer surface, and the gel layers of the first and second electrodes are oriented in an opposing relationship so as to allow electrical communication therebetween, thereby Without opening the package, a current loop is formed between the first electrode connecting means, the first electrode gel layer, the second electrode gel layer, and the second electrode connecting means. A sealed and sealed medical electrode system has been proposed.

  Moreover, the thing of patent document 2 is known as a package of the electrode for disposable defibrillators. Reference 2 includes (1) a base layer, (2) a gel layer in contact with a patient coated on the base layer, and (3) an electrically conductive gel layer attached to the first electrode. A first lead having a first end connected internally and a second end electrically connected internally to the defibrillator; and (4) protecting the first electrode before use. For this purpose, the first electrode and the first end of the first lead wire are covered with a normally gas-impermeable package. (5) Prior to opening the package and using the first electrode, A first disposable defibrillator electrode has been proposed in which the first lead wire extends from the package so that the second end of the lead wire can be internally connected to the defibrillator.

  In addition, this Patent Document 2 includes (1) a base layer, (2) a gel layer in contact with a patient coated on the base layer, and (3) an electroconductive gel layer attached to a second electrode. A second lead having a first end connected internally and a second end electrically connected internally to the defibrillator; and (4) a second electrode before use. For protection purposes, the second electrode and the first end of the second lead wire are usually covered with a gas-impermeable package, (5) prior to opening the package and using the second electrode, Disclosed is a second disposable defibrillator electrode having a configuration in which the second lead extends from the package so that the second end of the second lead can be internally connected to the defibrillator. Yes. The conductive gel layers of the first electrode and the second electrode are electrically connected to each other in the package, whereby the second ends of the first lead wire and the second lead wire are connected. It is disclosed that an electrical circuit is formed between the parts, and the electrical characteristics of the first electrode and the second electrode can be inspected before the package is opened.

  Further, Patent Document 3 is configured to inspect pinholes of sealed packages as a method for inspecting sealed packages in which consumable contents for medical use are encapsulated with an electrically insulating coating. A method and apparatus for inspecting sealed packages has been proposed.

  The inspection method of the sealed package described in Patent Document 3 is as follows: (1) Transporting a blood product and other various electrically conductive contents while encapsulating the package with an electrically insulating coating; Charge the sealed package with high voltage while simultaneously making contact with the opposite sides of the part where the contents exist among the two conductors arranged on the other side and the two conductors on the other side. In addition to detecting whether a current change has occurred in the part where the electrons are in contact with the part where at least one of the two conductors is in contact, and (3) the electric current of each conductor and the sealed package The incident end face of the optical fiber faces the front and back sides of the contact portion with the insulating coating, and it is detected whether or not light emission due to spark discharge occurs in the portion where each conductor is in contact via the optical fiber. (4) Conductor and electrical insulation film While detecting pinholes in sealed packages by detecting current changes in the contact area and detecting the presence or absence of light emission due to electric discharge, (5) detecting only one of the current change detection and the presence or absence of light emission It is possible to determine the defect of the detection means by detection.

US Pat. No. 5,402,884 US Pat. No. 5,579,919 JP 2003-35626 A

  The inventions described in Patent Document 1 and Patent Document 2 relate to a sealed package of disposable medical electrodes, and when using the sealed package electrode, without opening the sealed package, It has a feature that can inspect electrical characteristics of electrodes periodically sealed and packaged.

  However, in the inventions described in Patent Document 1 and Patent Document 2, as means for inspecting the electrical characteristics of the sealed electrode, the connection means connected to the electrode in order to connect the electrode to the electronic medical device. A part of the lead wire is previously led out to the outside of the sealed package body, and further, along with these lead wires, a conductive wire or a conductive piece for inspection with respect to the electrode is further provided, and one end thereof is outside the sealed package body. It consists of the derived structure.

  Thus, by sealing and packaging the electrode, it is possible to maintain safe and proper storage together with the gel substance applied to the electrode surface, but the lead wires connected to the electrodes as described above and Since one end of the conductive wire or piece for inspection is led out to the outside of the sealed package, it is necessary to secure the inside of the lead wire and the like where the lead wire is drawn out from the sealed package. . This complicates the structure for sealed packaging, and the sealed package has lead wires and the like pulled out to the outside, so that excessive force is applied to the lead wires and the like during handling, and the seal may be destroyed. There is.

  Further, the invention described in Patent Document 3 is intended for a sealed package in which a conductive content is encapsulated with an electrically insulating coating, and a pair of electrodes are brought into contact with or in close proximity to the sealed package. By applying a DC high voltage between the electrodes, the presence of a pinhole in the electrically insulating coating encapsulating the contents is detected by a spark discharge generated between the pinhole and the electrode. It is composed. Therefore, it is inappropriate to apply to a disposable medical electrode or the like as an object of such a sealed package.

  Therefore, the object of the present invention is to completely seal and package the biological electrode unit, and sufficiently and reliably suppress the progress of deterioration of the electrode member. It can be performed easily and easily without opening the sealed state periodically or non-periodically, and the pass / fail judgment can be achieved properly and quickly, and it is easy to handle when taking out from the sealed package. An object of the present invention is to provide a living body electrode unit package and a method for inspecting the quality thereof.

  The living body electrode unit package according to the present invention has first and second electrode members attached to a living body, and a parallel portion in which the respective covering members are integrally fixed in a parallel state. A first lead wire that is separated and connected to the first electrode member, a second lead wire that is connected to the second electrode member, and the other end side of the first and second lead wires A connector connected to the first and second lead wires, a first connection means for electrically connecting the first lead wire in the connector and the second electrode member; A second connecting means for electrically connecting the second lead wire and the first electrode member in the connector; the first and second electrodes; and the first and second lead wires. The living body electrode unit having the first and second connecting means is hermetically packaged. A closed circuit in which the first and second connecting means are connected in series by the first and second connecting means, and the first and second lead wires The parallel line portion is wound in a coil shape and sealed by the hermetic packaging member.

  The living body electrode unit package according to the present invention has first and second electrode members attached to a living body and a parallel line portion in which the respective covering members are integrally fixed in a parallel state. First lead wire separated on the side and connected to the first electrode member, second lead wire connected to the second electrode member, and the other end side of the first and second lead wires The first and second lead wires in the connector, the first lead wire in the connector and the first electrode member are electrically connected to each other, and only the first lead wire is connected. A first connecting means for forming a closed circuit including the second lead wire in the connector and the second electrode member to electrically connect between the second lead wire and the closed member including only the second lead wire. A second connecting means for forming a circuit; the first and second electrodes; And a hermetic packaging member that hermetically wraps the biomedical electrode unit including the first and second connecting means, and the parallel line portion is wound in a coil shape and sealed. It is sealed by a packaging member.

  The biological electrode unit package according to the present invention is the structure of claim 2, wherein the first and second lead wires are connected in parallel by sharing a part of the first connecting means and the second connecting means. It has a closed circuit.

  According to the biological electrode unit quality inspection method of the present invention, the biological electrode unit package according to any one of claims 1 to 3 is oscillated in proximity to a coil formed by winding the lead wire. By arranging a coil and a receiving coil, applying an AC voltage having a required frequency and voltage to the oscillation coil, and detecting the voltage generated in the receiving coil, it is possible to determine the quality of electrode members and the like. It is characterized by.

  The biological electrode unit quality determination inspection method according to the present invention is detected by bringing the biological electrode unit package according to any one of claims 1 to 3 close to a coil formed by winding the lead wire. A coil is arranged, an AC voltage having a required frequency is applied to the detection coil via a resistor, and the voltage of the detection coil is detected, thereby making it possible to determine whether the electrode member or the like is good or bad. .

  According to the living body electrode unit package of claims 1, 2, and 3 of the present invention, the entire living body electrode unit can be simply and easily completely sealed and packaged. The effective storage period of the biological electrode unit can be extended by suppressing the progress of deterioration. In addition, the biomedical electrode unit sealed and packaged can easily and easily determine the quality of an electrode member such as an electrode appropriately and quickly without opening. Moreover, since the parallel wire part which the 1st lead wire and the 2nd lead wire were integrally fixed by each coating | coated member is wound by the coil shape and sealed by the sealing packaging member, it took out from sealed packaging. Sometimes, there is an effect that the two lead wires are not intertwined and easy to handle.

  According to the quality determination inspection method for packaged biological electrode units according to claims 4 and 5 of the present invention, without opening the packaged biological electrode unit, periodically or irregularly, Inspection for determining the quality of electrode members such as electrodes can be performed easily and easily, and the quality of electrode members such as electrodes can be determined appropriately and quickly.

  In the present invention, the respective covering members in the first lead wire connected to the first electrode member and the second lead wire connected to the second electrode member are integrally fixed, Adopting a configuration in which the integrally fixed parallel line portions are wound in a coil shape and sealed with a sealing packaging member, and without sealing the sealed biological body electrode unit, the electrode member such as an electrode is opened. This achieves the purpose of making it possible to determine pass / fail appropriately and quickly and facilitating handling when taking out from sealed packaging.

  Hereinafter, with reference to the accompanying drawings, an embodiment of a biological electrode unit package according to the present invention and a quality determination inspection method thereof will be described. In the drawings, the same components are denoted by the same reference numerals, and redundant description is omitted. FIG. 1 shows a schematic cross-sectional view of a main part of a living body electrode unit package according to the present invention, and the living body electrode unit package is used for a defibrillator. In FIG. 1, reference numerals 10a and 10b denote flexible sheet electrodes, respectively, and conductive gel layers 12a and 12b are provided on one side surface of the flexible sheet electrodes 10a and 10b, and non-side surfaces are provided on the other side surfaces. A pair of electrode members 20a and 20b is configured by adhering the conductive members 14a and 14b with an adhesive.

  The pair of electrode members 20 a and 20 b configured as described above are bonded to each other so that the conductive gel layers 12 a and 12 b are opposed to each other with the separator 16 therebetween. Also, one end of each of the lead wires 22a and 22b is electrically connected to one end of the flexible sheet electrodes 10a and 10b via the crimping pins 18a and 18b. Reference numerals 15a and 15b denote non-conductive members that cover the connection portions between the flexible sheet electrodes 10a and 10b and the lead wires 22a and 22b.

  As shown in FIG. 2, each of the lead wires 22a and 22b has a parallel line portion 29 in which the respective covering members are integrally fixed in a parallel state and covered with the covering member at the end. The lead wire 22a and the lead wire 22b covered with the covering member are separated, the lead wire 22a is electrically connected to the electrode member 20a, and the lead wire 22b is electrically connected to the electrode member 20b. For example, when the total length of the lead wires 22a and 22b is about 1 m50 cm, the length of the parallel line portion 29 integrally fixed by the covering member can be about 1 m. The lead wires 22a and 22b are separated and joined to the connector 24 even at an end different from the end connected to the electrode members 20a and 20b.

  Reference numerals 25a and 25b denote auxiliary lead wires for use in the pass / fail judgment inspection of the biological electrode unit. As shown in FIG. 2, the auxiliary lead wire 25a is connected to the lead wire 22b in the connector 24, and the auxiliary lead wire 25 b is connected to the lead wire 22 a in the connector 24. The auxiliary lead wire 25a is electrically connected to a conductive material 27a provided between the conductive gel layer 12a of the electrode member 20a and the separator 16 on the other end side. The auxiliary lead wire 25b is electrically connected to the conductive material 27b provided between the conductive gel layer 12b of the electrode member 20b and the separator 16 on the other end side. As the conductive material 27a (27b), a metal-based sheet or conductive paint, more preferably, a carbon-based conductive material such as a carbon paint, a carbon sheet, or a carbon woven fabric in which carbon powder is mixed with a solvent is used. The conductive material 27a (27b) is attached to or applied to the separator 16, and as this configuration, the conductive material 27a is provided on the surface of one separator 16 as shown in FIG. The conductive material 27b is provided on the back surface, and the conductive materials 27a and 27b are provided side by side on the surface of one separator 16 as shown in FIG. 3B, and are folded from the center. As shown in FIG. 3 (c), a conductive material 27a is provided on one of the two separators 16 and 16, and a conductive material 27b is provided on the other, which are turned upside down and can be used.

  Here, the auxiliary lead wire 25a (25b) employs a non-conductive material coated with a plurality of fine metal wires, and when the auxiliary lead wire 25a (25b) and the conductive material 27a (27b) are electrically connected, As shown in FIG. 4, a plurality of fine metal wires M, which are exposed by peeling off the non-conductive material, are spread on the separator 16, and the fine metal wires M are covered with the conductive material 27a (27b). When the conductive material 27a (27b) is a sheet, the auxiliary lead wire 25a (25b) can be caulked and connected to the conductive material 27a (27b) using a pin or the like. The auxiliary lead wire 25a (25b) and the conductive material 27a (27b) are the first (second) electrical connection between the lead wire 22a (22b) and the electrode member 20a (20b) in the connector 24. A connection means is configured.

  With the configuration as described above, a closed circuit in which the lead wires 22a and 22b are connected in series by the first and second connection means is configured. In this closed circuit, for example, when a current flows from the electrode member 20a to the lead wire 22a, the current reaches the connector 24 via the lead wire 22a at the parallel wire portion 29 of the lead wires 22a and 22b. It reaches the auxiliary lead wire 25b, further flows to the lead wire 22b side through the conductive material 27b and the electrode member 20b, and reaches the connector 24 via the lead wire 22b again at the parallel wire portion 29 of the lead wires 22a and 22b. Thus, a closed circuit is formed so as to pass through the auxiliary lead wire 25a and reach the electrode member 20a from the conductive material 27a (see FIG. 2). At this time, current flows through the lead wires 22a and 22b in the same direction in the parallel line portions 29 of the lead wires 22a and 22b. And the parallel line part 29 in the said lead wires 22a and 22b is wound by the coil shape so that an electromotive force can be generated with an external magnetic field, and is arrange | positioned on one side surface of the pair of said electrode member 20a, 20b joined. Thus, the entire living body electrode unit is hermetically packaged by the non-magnetic and non-conductive hermetic packaging material 26 to form the living body electrode unit packaging 30 according to the present invention. With such a configuration, a closed circuit in which the lead wires 22a and 22b function as the series-connected coils L1 and L2 shown in FIG. 5A is completed. As the sealed packaging material 26, various known packaging materials for sealing and packaging various medical materials can be applied. According to this embodiment, the parallel wire portion 29 to which the lead wires 22a and 22b are integrally fixed is wound in a coil shape and sealed by the hermetic packaging member 26. The lead wires are not intertwined and easy to handle.

  FIG. 2 shows a setting state when packaging the biological electrode unit in the biological electrode unit package 30 described above. That is, in the pair of electrode members 20 a and 20 b described above, the conductive gel layers are opposed to each other and are joined to each other via the separator 16. Next, the lead wires 22a and 22b respectively led out from the electrode members 20a and 20b and the auxiliary lead wires 25a and 25b are connected in the connector 24 in the connection relationship as described above, and the auxiliary lead wires 25a and 25b are not connected. A plurality of thin metal wires M exposed by peeling off the conductive material is spread on the separator 16, and the thin metal wires M are covered with the conductive materials 27a and 27b to form one closed circuit in which the lead wires 22a and 22b are connected in series. Form. And the parallel line part 29 in the said lead wires 22a and 22b is wound in a fixed direction like illustration, and is arrange | positioned on one side surface of said pair of electrode member 20a, 20b. The auxiliary lead wires 25a and 25b have a short length, and are arranged between the end portions of the electrode members 20a and 20b and the connector 24 as shown in FIG. The biological electrode unit set in this manner is hermetically packaged by a hermetic packaging material 26 as shown in FIG.

  Next, a quality determination inspection method for the flexible sheet electrodes 10a and 10b of the biological electrode unit with respect to the biological electrode unit package 30 having the above-described configuration will be described.

  FIG. 6 shows the flexible sheet electrodes 10a, 10b, etc. of the biological electrode unit in a packaged state periodically or irregularly without opening the biological electrode unit package 30 according to the present invention described above. 1 shows an embodiment of a device configuration for carrying out an inspection method for performing a pass / fail determination on a device. That is, the apparatus for carrying out the inspection method of this embodiment is a coil formed by winding the parallel wire portion 29 of the lead wires 22a and 22b in a certain direction around the biological electrode unit package 30 in FIG. Concentrically with the oscillating coil 32 and the receiving coil 36 at the upper and lower positions, respectively, and the oscillating coil 32 is connected to the oscillator 34 to apply an AC voltage of a required frequency and voltage, The receiving coil 36 is connected to voltage (electromotive force) detection means 38 such as an oscilloscope to detect a voltage (electromotive force) generated. When the flexible sheet electrodes 10a, 10b, etc. deteriorate, the internal resistance increases, and the voltage (electromotive force) generated in the receiving coil 36 increases. Therefore, by configuring as described above, it is possible to determine whether the flexible sheet electrodes 10a, 10b, etc. are good or bad based on the voltage (electromotive force) detection output of the voltage (electromotive force) detection means 38 of the oscilloscope or the like. Become.

Next, an example of a change in voltage generated in the reception coil 36 with respect to a change in internal resistance of a closed circuit including the pair of electrode members 20a and 20b will be described as a specific example. In order to vary the internal resistance, measurement was performed by inserting a variable resistor in series in the closed circuit.
The parallel wire portions 29 of the lead wires 22a and 22b are formed in a coil shape with a diameter of about 100 mm and a winding number of 5 turns, and the oscillation coil 32 and the receiving coil 36 are respectively configured as a coil with a diameter of about 120 mm and a winding number of 20 turns. The coils 32 and 36 are arranged to face each other with a distance of about 20 mm, and the biological electrode unit package 30 having a thickness of about 10 mm is arranged between the coils 32 and 36 with a parallel line portion in the lead wires 22a and 22b. The coil formed by winding 29 in a fixed direction was inserted and arranged so as to be concentric with the coils 32 and 36. Further, the oscillation coil 32, the reception coil 36, and the biological electrode unit package 30 were fixed with an appropriate jig or the like so that the relative positions thereof were not shifted. In this way, a voltage having a frequency of 500 KHz and an output (pp) of 2 V was applied to the oscillation coil 32 by the oscillator 34.

  In a normal state, the internal resistance of one closed circuit including the pair of electrode members 20a and 20b in the biological electrode unit is about 4Ω, but the electrical characteristics are deteriorated due to deterioration of the flexible sheet electrodes 10a and 10b and the like. As the value decreases, the internal resistance increases. Therefore, the variable resistor inserted in the closed circuit in the biological electrode unit is changed in the range of 0 to 25Ω (total internal resistance is 4 to 29Ω), and voltage (electromotive force) detection means such as an oscilloscope at that time As a result of measuring the voltage (electromotive force) detected by 38, the characteristic that the detected voltage increases (200 to 600 mV) as the internal resistance increases as shown in FIG. 7 was obtained.

  Therefore, according to the present embodiment, if the detected value of the voltage (electromotive force) detected by the voltage (electromotive force) detecting means 38 is not more than a required reference value, the flexible sheet electrodes 10a, 10b, etc. When it is determined that the detection value is appropriate and the detected value is larger than a required reference value, the flexible sheet electrodes 10a and 10b can be determined to be defective. Since the detection value varies depending on the type of the biomedical electrode unit and the apparatus that performs the inspection method such as the oscillation coil and the reception coil, the reference value is set to an appropriate value.

  In the embodiment of the apparatus configuration that implements the inspection method for determining the quality of the biological electrode unit package 30 described above, the oscillation coil 32 and the reception coil 36 are concentric with the biological electrode unit package 30. However, the arrangement of the coils 32 and 36 is not limited to this. For example, both the oscillating coil 32 and the receiving coil 36 are arranged close to each other in the vertical direction, and both the arranged coils are arranged close to either above or below the living body electrode unit package 30. May be. Also in this case, the coils 32 and 36 and the living body electrode unit package 30 are fixed with an appropriate jig or the like so that the relative positions of the coils 32 and 36 and the living body electrode unit package 30 do not shift. In the case of such a configuration example, the change in the voltage (electromotive force) generated in the receiving coil 36 with respect to the change in the internal resistance is smaller than in the above-described embodiment.

  Next, another embodiment of the apparatus configuration for carrying out an inspection method for performing pass / fail judgment on the flexible sheet electrodes 10a, 10b, etc. of the living body electrode unit in the packaged state will be described with reference to FIG. To do. In the above-described embodiment, two coils of the oscillation coil 32 and the reception coil 36 are used. However, in this embodiment, one coil is used. That is, in FIG. 8, the detection coil 40 is disposed so as to be close to the upper side of the biological electrode unit package 30 and the relative position with respect to the biological electrode unit package 30 is not shifted. The terminal 40 a of the detection coil 40 is connected to the oscillator 34 via the resistor 42, and the terminal 40 b is directly connected to the oscillator 34. The oscillator 34 applies an AC voltage having a required frequency and voltage to the detection coil 40 via the resistor 42. Further, the terminals 40a and 40b of the detection coil 40 are connected to voltage (electromotive force) detection means 38 such as an oscilloscope, and are configured to detect the voltage between the two terminals.

  With this configuration, as described above, when the flexible sheet electrodes 10a, 10b, etc. are deteriorated, the internal resistance of one closed circuit including the pair of electrode members 20a, 20b is increased. The terminal voltage of the coil 40 increases. Therefore, according to the present embodiment, the quality of the flexible sheet electrodes 10a, 10b, etc. can be determined based on the detection output of the detection means 38.

  Next, a second embodiment of the biological electrode unit package according to the present invention will be described. In the second embodiment, as shown in FIG. 9, the connection relationship between the lead wires 22a and 22b and the auxiliary lead wires 25a and 25b in the connector 24 is different from that in the first embodiment. That is, the auxiliary lead wire 25 a is connected to the lead wire 22 a in the connector 24, and the auxiliary lead wire 25 b is connected to the lead wire 22 b in the connector 24. The conductive materials 27a and 27b are carbon sheets, and the auxiliary lead wires 25a and 25b are caulked and connected to each other with pins or the like and placed on the conductive gel layers 12a and 12b. It can also be configured in the same manner as the embodiment. The other configuration is the same as that of the first embodiment.

  With the connection as described above, the auxiliary lead wire 25a as the first connection means and the conductive material 27a constitute a closed circuit including only the lead wire 22a, and the auxiliary lead as the second connection means. A closed circuit including only the lead wire 22b is constituted by the wire 25b and the conductive material 27b. That is, two independent closed circuits are formed. In the closed circuit including only the lead wire 22a, for example, when a current flows from the electrode member 20a to the lead wire 22a side, the current is connected to the connector via the lead wire 22a at the parallel line portion 29 of the lead wires 22a and 22b. 24, and returns to the electrode member 20a through the auxiliary lead wire 25a and the conductive material 27a. On the other hand, in a closed circuit including only the lead wire 22b, for example, when a current flows from the electrode member 20b to the lead wire 22b side, the current flows through the lead wire 22b at the parallel line portion 29 of the lead wires 22a and 22b. To the connector 24 and return to the electrode member 20b through the auxiliary lead wire 25b and the conductive material 27b. At this time, current flows through the lead wires 22a and 22b in the same direction in the parallel line portions 29 of the lead wires 22a and 22b.

  As shown in FIGS. 1 and 9, the parallel wire portions 29 of the lead wires 22a and 22b are wound in a coil shape that can generate an electromotive force by an external magnetic field, and the pair of electrode members 20a and 20b joined together. The living body electrode unit package 30 according to the present invention is configured by being disposed on one side surface and hermetically sealed by the nonmagnetic and non-conductive sealing packaging material 26. With such a configuration, two closed circuits in which the portions of the lead wires 22a and 22b act as independent coils L1 and L2 shown in FIG. 5B are completed. Also in this embodiment, since the parallel wire portion 29 to which the lead wires 22a and 22b are integrally fixed is wound in a coil shape and sealed by the hermetic packaging member 26, the two leads are taken out from the hermetic packaging. The lines are not intertwined and easy to handle. The quality determination inspection method for the flexible sheet electrodes 10a, 10b, etc. of the biological electrode unit with respect to the biological electrode unit package 30 configured as described above will be described in the first embodiment with reference to FIGS. Since it is the same as what was demonstrated as the test | inspection method with respect to the biological electrode unit package 30 which concerns, the detailed description is abbreviate | omitted.

  Next, a third embodiment of the biological electrode unit package according to the present invention will be described. In the third embodiment, the living body electrode unit package according to the second embodiment is changed, and as shown in FIG. 10, the first connecting means and a part of the second connecting means. And having a closed circuit in which lead wires 22a and 22b are connected in parallel. That is, the auxiliary lead wire 25a and the conductive material 27a as the first connection means, and the auxiliary lead wire 25a and the auxiliary lead wire 25b among the auxiliary lead wire 25b and the conductive material 27b as the second connection means. The central part is electrically constituted by a single electric circuit 25.

  As shown in FIGS. 1 and 10, the parallel line portions 29 of the lead wires 22a and 22b are wound in a coil shape that can generate an electromotive force by an external magnetic field, and the pair of electrode members 20a and 20b joined to each other. The living body electrode unit packaging body 30 according to the present invention is configured by arranging the living body electrode unit on one side and sealing and packaging the whole living body electrode unit with a non-magnetic and non-conductive sealing packaging material 26. With such a configuration, the portions of the lead wires 22a and 22b act as the coils L1 and L2, and the coils L1 and L2 are connected in parallel as shown in FIG. The closed circuit connected by is completed.

  In this circuit, for example, a current flows through the electric circuit 25 and branches to the auxiliary lead wires 25a and 25b. One current flows from the electrode member 20a to the lead wire 22a side, and a parallel line portion 29 in the lead wires 22a and 22b. To the connector 24 through the lead wire 22a and return to the electric circuit 25 through the auxiliary lead wire 25a. On the other hand, the current branched to the auxiliary lead wire 25b flows from the electrode member 20b to the lead wire 22b, reaches the connector 24 via the lead wire 22b at the parallel wire portion 29 of the lead wires 22a and 22b, and reaches the auxiliary lead wire 25b. Return to the electric circuit 25 via. At this time, current flows through the lead wires 22a and 22b in the same direction in the parallel line portions 29 of the lead wires 22a and 22b.

  Also in the present embodiment, since the lead wires 22a and 22b are wound in a coil shape with the parallel wire portion 29 wound and sealed by the hermetic packaging member 26, the two lead wires may be entangled when taken out from the hermetic packaging. Not easy to handle. The quality determination inspection method for the flexible sheet electrodes 10a, 10b, etc. of the biological electrode unit with respect to the biological electrode unit package 30 configured as described above will be described in the first embodiment with reference to FIGS. Since it is the same as what was demonstrated as the test | inspection method with respect to the biological electrode unit package 30 which concerns, the detailed description is abbreviate | omitted.

The principal part cross-section schematic block diagram which shows the 1st Example of the electrode unit package for biological bodies which concerns on this invention. The schematic perspective view which shows the setting state at the time of packaging of the biological electrode unit in the biological electrode unit packaging body which concerns on 1st Example of this invention. The top view which shows the structural example in the case of arrange | positioning the electroconductive material used for the biological electrode unit package which concerns on this invention to a separator. The top view which shows the example of a connection in the case of electrically connecting the auxiliary | assistant lead wire used for the biological body electrode unit package which concerns on this invention, and an electroconductive material. The circuit diagram of the closed circuit containing the coil comprised by winding the lead wire in the electrode unit package for biological bodies which concerns on this invention is shown, (a) is a circuit diagram of a 1st Example, (b) is The circuit diagram of 2nd Example, (c) is the circuit diagram of 3rd Example. BRIEF DESCRIPTION OF THE DRAWINGS Schematic explanatory drawing which shows one Example of the apparatus structure which implements the quality determination test | inspection method of the packaged biological electrode unit which concerns on this invention. The characteristic line figure which shows the relationship between the internal resistance of the closed circuit which the biological electrode unit forms in the case of performing the quality determination test | inspection of the packaged biological electrode unit which concerns on this invention, and a detection voltage (electromotive force). Schematic explanatory drawing which shows another Example of the apparatus structure which implements the quality determination test | inspection method of the packaged biological electrode unit which concerns on this invention. The schematic perspective view which shows the setting state at the time of packaging of the biological electrode unit in the biological electrode unit packaging body which concerns on 2nd Example of this invention. The schematic perspective view which shows the setting state at the time of packaging of the biological electrode unit in the biological electrode unit packaging body which concerns on 3rd Example of this invention.

Explanation of symbols

10a, 10b Flexible sheet electrodes 12a, 12b Conductive gel layers 14a, 14b Non-conductive members 15a, 15b Non-conductive members 16 Separator 18a, 18b Crimp pins 20a, 20b Electrode members 22a, 22b Lead wire 24 Connector 25 Conductive Paths 25a and 25b Auxiliary lead wire 26 Sealed packaging materials 27a and 27b Conductive material 29 Parallel line portion 30 Biological electrode unit packaging body 32 Oscillation coil 34 Oscillator 36 Reception coil 38 Voltage (electromotive force) detection means 40 Detection coils 40a and 40b Terminal 42 resistor

Claims (5)

First and second electrode members attached to a living body;
Connected to the first lead wire and the second electrode member which have parallel line portions in which the respective covering members are integrally fixed in parallel and are separated at one end side and connected to the first electrode member A second lead wire,
A connector connected to the first and second lead wires on the other end side of the first and second lead wires;
First connection means for electrically connecting the first lead wire in the connector and the second electrode member;
Second connection means for electrically connecting the second lead wire in the connector and the first electrode member;
A hermetic packaging member that hermetically packages the biological electrode unit including the first and second electrodes, the first and second lead wires, and the first and second connection means;
The first and second connecting means constitute a closed circuit in which the first and second lead wires are connected in series, and the parallel line portion is wound in a coil shape and sealed by the hermetic packaging member. A living body electrode unit package. First and second electrode members attached to a living body;
Connected to the first lead wire and the second electrode member which have parallel line portions in which the respective covering members are integrally fixed in parallel and are separated at one end side and connected to the first electrode member A second lead wire,
A connector connected to the first and second lead wires on the other end side of the first and second lead wires;
First connection means for electrically connecting between the first lead wire and the first electrode member in the connector to form a closed circuit including only the first lead wire;
Second connection means for forming a closed circuit including only the second lead wire by electrically connecting the second lead wire and the second electrode member in the connector;
A hermetic packaging member that hermetically packages the biological electrode unit including the first and second electrodes, the first and second lead wires, and the first and second connection means;
The living body electrode unit packaging body, wherein the parallel line portion is wound in a coil shape and sealed by the sealing packaging member. The living body electrode unit according to claim 2, further comprising a closed circuit in which a part of the first connecting means and the second connecting means is shared and the first and second lead wires are connected in parallel. Packaging body.   The living body electrode unit package according to any one of claims 1 to 3, wherein an oscillating coil and a receiving coil are disposed in proximity to a coil formed by winding the lead wire, A pass / fail judgment test for a packaged biological electrode unit, wherein an AC voltage consisting of a frequency and a voltage is applied and a voltage generated in the receiving coil is detected, thereby making it possible to judge pass / fail of an electrode member or the like. Method.   The living body electrode unit package according to any one of claims 1 to 3, wherein a detection coil is disposed in proximity to a coil formed by winding the lead wire, and the detection coil is provided with a resistor via a resistor. A method for inspecting the quality of a packaged biological electrode unit, comprising: applying an AC voltage having a frequency of 5 and detecting the voltage of the detection coil to enable determination of the quality of an electrode member or the like.

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